Alinity Ci-Series Operations Manual PDF

Alinity ci‑series Operations
Manual
For use with the Alinity c processing module and the Alinity i processing module
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Table of contents
Read me first........................................................................................ 13
What's new............................................................................................................................... 14
General safety information...................................................................................................... 18
System security........................................................................................................................ 19
Customer service..................................................................................................................... 20
Intended use............................................................................................................................. 21
Proprietary statement...............................................................................................................22
Disclaimers............................................................................................................................... 23
Alinity ci‑series warranty statement for USA customers only................................................25
Alinity ci‑series agency approvals........................................................................................... 26
Intellectual Property statement................................................................................................27
Key to symbols......................................................................................................................... 28
System documentation...........................................................................33
Organization of the operations manual...................................................................................34
Conventions for the operations manual..................................................................................36
Operations manual description................................................................................................37
Toolbar.......................................................................................................................... 38
Navigation pane............................................................................................................ 38
Topic pane.................................................................................................................... 43
Operations manual use............................................................................................................45
Access the operations manual.....................................................................................45
Display and use the procedure map............................................................................46
Use the table of contents............................................................................................. 46
Scroll through a topic or the table of contents...........................................................46
Play an animation......................................................................................................... 47
Access the related information.................................................................................... 48
Use breadcrumbs to access a topic............................................................................48
Redisplay a topic...........................................................................................................49
Page through the content.............................................................................................49
Use the Toggle TOC button......................................................................................... 49
Use the index................................................................................................................ 49
Use the glossary........................................................................................................... 50
Search for a term......................................................................................................... 50
Resize, move, and close the operations manual........................................................ 50
Print a topic from the operations manual....................................................................51
Procedure map description..................................................................................................... 52
Procedure map task lists..............................................................................................53
Use or function..................................................................................... 55
Alinity ci‑series hardware overview......................................................................................... 56
Primary components of an Alinity ci‑series................................................................. 56
Alinity system software overview...........................................................................................139
Descriptions of screen elements............................................................................... 140
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Menu bar..................................................................................................................... 144

Required consumables.......................................................................................................... 146
Reagent kits and components....................................................................................146
Controls....................................................................................................................... 148
Calibrators................................................................................................................... 149
Bulk solutions (c‑series).............................................................................................150
Bulk solutions (i‑series)..............................................................................................151
Onboard solutions (c‑series)......................................................................................152
Maintenance solutions (c‑series)...............................................................................153
ICT module (c‑series).................................................................................................154
Probe conditioning solution (i‑series)........................................................................ 154
Reaction vessels (i‑series).........................................................................................155
Sample cups............................................................................................................... 156
Required accessories............................................................................................................ 157
Racks...........................................................................................................................157
Trays............................................................................................................................158
Reagent cartridge with empty bottles (c‑series).......................................................158
Automatic processing module activities................................................................................161
System flush (c‑series).............................................................................................. 161
System flush (i‑series)............................................................................................... 161
System prime (i‑series).............................................................................................. 162
Processing module wash (c‑series).......................................................................... 162
Automatic rotation of the reagent carousel (c‑series)............................................. 163
Installation procedures and special requirements.....................................165
System installation and relocation........................................................................................ 166
System installation...................................................................................................... 166
System checkout........................................................................................................ 166
System relocation....................................................................................................... 167
System configuration............................................................................................................. 168
Configure screen, General tab.................................................................................. 168
Configure screen, Computer tab............................................................................... 216
Configure screen, Assay tab......................................................................................250
Configure screen, Maintenance & Diagnostics tab.................................................. 367
Utilities screen........................................................................................................................379
Backup/Restore screen..............................................................................................379
System Updates screen............................................................................................. 384
Troubleshooting screen.............................................................................................. 395
Current Software screen............................................................................................ 397
Current Firmware screen............................................................................................398
View or print the Licenses Report..............................................................................399
Principles of operation......................................................................... 401
Principles of operation (c‑series)..........................................................................................402
Photometric method (c‑series).................................................................................. 402
Potentiometric method (c‑series).............................................................................. 408
Assay processing (c‑series).......................................................................................414
Indirect assay processing method (c‑series)............................................................ 423
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Table of contents
SmartWash feature (c‑series)....................................................................................423

Optimum sampling sequence feature (c‑series)...................................................... 424
Sample interference indices (c‑series)..................................................................... 425
Principles of operation (i‑series)...........................................................................................428
CMIA method (i‑series).............................................................................................. 428
Assay processing (i‑series)........................................................................................433
Performance characteristics and specifications....................................... 443
System characteristics...........................................................................................................444
Processing module characteristics (c‑series)...........................................................444
Processing module characteristics (i‑series)............................................................445
Specifications and requirements...........................................................................................446
Operational specifications..........................................................................................446
System capacities.......................................................................................................449
Physical specifications............................................................................................... 452
Typical floor loading................................................................................................... 453
System clearances..................................................................................................... 455
Electrical specifications and requirements............................................................... 455
Optical specifications (c‑series)................................................................................ 458
Water and liquid waste specifications and requirements.........................................459
Environmental specifications and requirements....................................................... 461
Computer and interface specifications......................................................................462
External waste pump specifications and requirements............................................ 463
Bar code label requirements......................................................................................465
Sample specifications and requirements.................................................................. 472
Operating instructions..........................................................................479
System cycle power, start, pause, and stop........................................................................ 480
Cycle power to the system.........................................................................................480
Cycle power to the processing module and the reagent and sample manager
(RSM)..................................................................................................................... 484
Power on the user interface (UI) computer.............................................................. 488
Power off the user interface (UI) computer..............................................................488
Power on the processing module.............................................................................. 489
Power off the processing module..............................................................................494
Power on the reagent and sample manager (RSM).................................................497
Power off the reagent and sample manager (RSM)................................................ 499
Start the processing module and the reagent and sample manager (RSM).......... 500
Pause the processing module....................................................................................500
Pause the reagent and sample manager (RSM)...................................................... 501
Stop the processing module and the reagent and sample manager (RSM).......... 502
Perform an emergency shutdown..............................................................................502
Long-term shutdown (i‑series)................................................................................... 505
Log On screen........................................................................................................................507
Log On screen element descriptions.........................................................................507
Log on..........................................................................................................................510
Lock the user interface.............................................................................................. 510
Notepad flyout........................................................................................................................ 511

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Notepad flyout element descriptions......................................................................... 511

Add Note flyout element descriptions........................................................................513
Add Comment flyout element descriptions................................................................513
View a note................................................................................................................. 514
Create a note.............................................................................................................. 514
Pin or unpin a note..................................................................................................... 515
Edit a note................................................................................................................... 515
Add a comment to a note...........................................................................................516
Delete a note...............................................................................................................517
Delete all unpinned notes...........................................................................................517
Home screen.......................................................................................................................... 519
Home screen element descriptions........................................................................... 520
Host Connection Status flyout....................................................................................529
Printer Status/Queue flyout........................................................................................532
Alinity PRO Connection Status flyout........................................................................ 534
LAS Connection Status flyout.................................................................................... 534
AbbottLink Connection Status flyout..........................................................................537
Abbott Mail Inbox screen............................................................................................538
Instrument statuses.....................................................................................................557
Consumable inventory management.....................................................................................561
Supplies screen.......................................................................................................... 561
Cal/QC Inventory screen............................................................................................ 587
Reagent and sample management....................................................................................... 592
Load racks and cartridges into trays......................................................................... 592
Load trays on the reagent and sample manager (RSM)..........................................594
Load racks on the reagent and sample manager (RSM).........................................595
Load bar-coded specimens for batch processing.................................................... 597
Load cartridges on the reagent and sample manager (RSM)................................. 599
Load onboard vial racks or cartridges on a specific processing module............... 602
Load onboard solutions and sample diluents on the reagent and sample
manager (RSM) (c‑series).................................................................................... 604
Assign a temporary priority position to load racks and cartridges.......................... 606
Unload trays from the reagent and sample manager (RSM)...................................607
Reagent carousel inventory management.................................................................607
Sample management..................................................................................................636
Specimen, calibration, and control orders............................................................................652
Automated ordering.................................................................................................... 652
Orders screen............................................................................................................. 659
Sample Status screen................................................................................................ 693
Results screen........................................................................................................................706
Results screen, Unreleased tab element descriptions............................................. 707
Results screen, Specimen tab element descriptions................................................708
Results screen, Control tab element descriptions.................................................... 710
Results screen, Exception tab element descriptions................................................711
Results screen, Search flyout element descriptions................................................ 713
Result Details screen..................................................................................................715
Rerun Options (Specimen Order) flyout element descriptions................................ 719

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Rerun Options (Control Order) flyout element descriptions.....................................720

Descriptions of specimen result flags....................................................................... 722
Descriptions of quality control result flags................................................................724
Descriptions of transmission statuses....................................................................... 725
View the reaction graph and absorbance data for a result (c‑series)....................726
Delete a sample result or an exception.................................................................... 727
Transmit a result or an exception to the host...........................................................727
Quality control analysis..........................................................................................................729
Westgard rule application...........................................................................................729
Levey-Jennings (Graph) screen.................................................................................733
Quality Control Summary screen...............................................................................740
Print flyout.............................................................................................................................. 751
Print flyout element descriptions................................................................................752
Report File Location window element descriptions.................................................. 754
Print a report............................................................................................................... 755
Print a screen image.................................................................................................. 756
Search flyout.......................................................................................................................... 757
Search for or filter data..............................................................................................757
Archive flyout..........................................................................................................................759
Archive flyout element descriptions...........................................................................759
Archive File Location window element descriptions................................................. 760
Archive the results...................................................................................................... 761
Archive the calibrations.............................................................................................. 762
Insert and remove a USB flash drive....................................................................................764
Calibration procedures......................................................................... 767
Calibration guidelines.............................................................................................................768
Calibration types and methods..............................................................................................769
Calibration method (c‑series potentiometric)............................................................769
Calibration types and methods (c‑series photometric)............................................ 774
Calibration types and methods (i‑series).................................................................. 784
Calibration storage.................................................................................................................793
Active calibration storage...........................................................................................793
Inactive calibration storage........................................................................................ 794
Failed calibration storage...........................................................................................794
Calibration review...................................................................................................................795
System calibration verification................................................................................... 795
Calibration Status screen........................................................................................... 796
Descriptions of calibration statuses...........................................................................804
View the assay calibration status.............................................................................. 805
Transmit a calibration to the host.............................................................................. 806
Fail a calibration......................................................................................................... 806
Operational precautions and limitations..................................................809
General requirements............................................................................................................ 810
Precautions and requirements for system operation........................................................... 811
Precautions and requirements before operation...................................................... 811
Precautions during operation..................................................................................... 811

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Requirements for handling the consumables.......................................................................812

Requirements for storage...........................................................................................812
Requirements for use................................................................................................. 812
Requirements for handling the specimens........................................................................... 814
Limitations of result interpretation.........................................................................................816
Hazards.............................................................................................. 817
Operator responsibility........................................................................................................... 818
Safety icons............................................................................................................................819
Biological hazards..................................................................................................................821
Precautions................................................................................................................. 821
Chemical hazards.................................................................................................................. 823
General precautions................................................................................................... 823
Sodium azide...............................................................................................................824
Sensitizers................................................................................................................... 825
Dry ice......................................................................................................................... 825
Waste handling and disposal................................................................................................ 826
Liquid wastes that contain (potentially) infectious materials................................... 826
Batteries...................................................................................................................... 827
Spill cleanup...........................................................................................................................828
Requirements for decontamination....................................................................................... 829
Preparation of sodium hypochlorite solutions........................................................... 829
Sodium hypochlorite stability......................................................................................830
Electrical hazards.................................................................................................................. 832
Mechanical hazards...............................................................................................................833
Physical hazards.................................................................................................................... 835
Probes and other sharps............................................................................................835
Heavy objects..............................................................................................................835
Hot objects.................................................................................................................. 836
Tripping hazards......................................................................................................... 836
Service, maintenance, and diagnostics................................................... 837
Maintenance and diagnostics................................................................................................838
Procedures screen..................................................................................................... 838
Procedures Log screen.............................................................................................. 851
Descriptions of maintenance and diagnostic procedure statuses........................... 856
Maintenance procedure descriptions........................................................................ 857
Unscheduled cleaning................................................................................................ 873
Diagnostic procedure descriptions............................................................................ 875
Component replacement....................................................................................................... 920
Processing center component replacement (c‑series)............................................ 920
Supply and pump center component replacement (c‑series)................................. 957
Processing center component replacement (i‑series)............................................. 989
Supply center component replacement (i‑series).................................................. 1008
Optional component replacement............................................................................1017
Troubleshooting.................................................................................1023
Approach to troubleshooting............................................................................................... 1024

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System troubleshooting variables (c‑series)...........................................................1025

System troubleshooting variables (i‑series)............................................................ 1027
Reagent troubleshooting variables (c‑series)......................................................... 1029
Reagent troubleshooting variables (i‑series).......................................................... 1030
Operator troubleshooting variables......................................................................... 1031
Environmental troubleshooting variables.................................................................1032
Alert Center flyout................................................................................................................1033
Alert Center flyout element descriptions................................................................. 1033
View the probable cause and corrective action for a message............................ 1034
View additional messages that are associated with a message........................... 1034
Delete a message from the Alert Center................................................................ 1035
Clear all messages...................................................................................................1035
System Logs screen............................................................................................................ 1036
System Logs screen, Notifications/Alerts tab element descriptions......................1036
System Logs screen, Informational tab element descriptions............................... 1038
System Logs screen, Inventory tab element descriptions......................................1039
System Logs screen, User Access tab element descriptions................................1040
System Logs screen, Configuration tab element descriptions...............................1041
System Logs screen, Interfaces tab element descriptions.................................... 1042
System Logs screen, Abbott Mail tab element descriptions.................................. 1043
System Logs screen, All Messages tab element descriptions...............................1044
System Logs screen, Search flyout element descriptions..................................... 1046
Message Details For flyout element descriptions...................................................1049
Descriptions of message types................................................................................1049
Message codes.................................................................................................................... 1051
General message codes (0001-0999).................................................................... 1051
Assay-specific message codes (1000-1999)..........................................................1108
Maintenance and diagnostic message codes (2000-2999)...................................1173
Level sense and fluidics message codes (3000-3999)......................................... 1199
Optics and bar code reader message codes (4000-4999)................................... 1259
Robotics and sensor message codes (5000-5999)................................................1269
Support system message codes (6000-6999)........................................................1346
Temperature message codes (7000-7999)............................................................ 1346
Computer hardware peripheral message codes (8000-8999)...............................1353
Software message codes (9000-9999)...................................................................1378
Observed problems..............................................................................................................1417
Processing module observed problems.................................................................. 1417
Processing module observed problems (c‑series)................................................. 1418
Processing module observed problems (i‑series).................................................. 1422
Sample results observed problems (c‑series)........................................................ 1424
Sample results observed problems (i‑series)......................................................... 1435
User interface (UI) computer observed problems.................................................. 1446
Printer observed problems....................................................................................... 1446
Miscellaneous corrective action procedures......................................................................1449
Processing module corrective action procedures.................................................. 1449
Reagent and sample manager (RSM) corrective action procedure......................1464
User interface (UI) computer corrective action procedures.................................. 1465

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Verification of assay claims................................................................. 1471

Limit of blank, limit of detection, and limit of quantitation.................................................1472
Verify a limit of blank (LoB) claim........................................................................... 1472
Verify a limit of detection (LoD) claim.....................................................................1475
Limit of quantitation (LoQ)....................................................................................... 1478
Precision............................................................................................................................... 1489
Verify the precision...................................................................................................1489
Evaluate the precision data......................................................................................1490
Calculate a precision verification value.................................................................. 1492
Precision worksheet (c‑series)................................................................................ 1493
Precision worksheet (i‑series)..................................................................................1495
Perform a calibration verification........................................................................................1497
Calibration verification worksheet (c‑series)...........................................................1498
Calibration verification worksheet (i‑series)............................................................1499
Verify the linearity................................................................................................................ 1501
Linearity worksheet (c‑series)..................................................................................1502
Linearity worksheet (i‑series)...................................................................................1503
Measuring interval................................................................................................................1505
Verify an automated dilution................................................................................................1506
Automated dilution verification worksheet (c‑series)..............................................1507
Automated dilution verification worksheet (i‑series)...............................................1508
Method comparison............................................................................................................. 1511
Perform a quantitative method comparison............................................................ 1511
Perform a qualitative method comparison.............................................................. 1518
Verify the reference range (expected values)................................................................... 1525
Reference range (expected values) worksheet (c‑series).....................................1526
Reference range (expected values) worksheet (i‑series)......................................1527
List numbers..................................................................................... 1529
Consumable list numbers.................................................................................................... 1530
Consumable list numbers (c‑series)...................................................................................1531
Consumable list numbers (i‑series).................................................................................... 1532
Service accessory list numbers.......................................................................................... 1533
Service accessory list numbers (c‑series)......................................................................... 1534
Service accessory list numbers (i‑series).......................................................................... 1537
Assay applications (c‑series photometric)............................................. 1539
Assay parameters (c‑series photometric, user defined)................................................... 1540
Assay Parameters screen element descriptions (c‑series photometric, user
defined)................................................................................................................ 1541
Create Assay flyout element descriptions...............................................................1542
Assay Parameters screen, General tab element descriptions (c‑series
photometric, user defined)..................................................................................1543
New Reagent flyout element descriptions (c‑series photometric, user defined)..1553
View/Edit Reagent flyout element descriptions (c‑series photometric, user
defined)................................................................................................................ 1554

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Assay Parameters screen, Calibration tab element descriptions (c‑series

New Cal Set flyout element descriptions (c‑series photometric, user defined)... 1563
Assay Parameters screen, Results tab element descriptions (c‑series
Assay Parameters screen, SmartWash tab element descriptions (c‑series)....... 1569
Color correction (c‑series photometric).................................................................. 1574
Dispense types (c‑series)........................................................................................ 1577
FlexRate method and absorbance range (c‑series photometric)..........................1578
Linearity flagging (c‑series)..................................................................................... 1581
Maximum absorbance variation (c‑series photometric)......................................... 1583
Maximum curve fit (c‑series photometric).............................................................. 1585
Photometric timing table (c‑series photometric).....................................................1586
Rate linearity percent (c‑series photometric)......................................................... 1587
Reaction check (c‑series photometric)................................................................... 1590
Sample dilution (c‑series photometric)................................................................... 1592
Self blank (c‑series photometric)............................................................................ 1595
Calculate a calibration factor (c‑series photometric)............................................ 1597
Create a user-defined assay (c‑series photometric)............................................. 1598
Perform an initial user-defined assay run (c‑series)..............................................1603
Reagent carryover evaluation (c‑series)............................................................................ 1605
Perform a reagent carryover evaluation (c‑series)................................................ 1605
Configure and verify SmartWash settings (c‑series)..............................................1608
Edit SmartWash settings (c‑series)......................................................................... 1610
Printed report element descriptions...................................................... 1613
Absorbance Data Report element descriptions (c‑series)................................................ 1614
Assay Information Report element descriptions.................................................................1617
Assay Installation Report element descriptions..................................................................1618
Assay Parameter Report element descriptions (c‑series).................................................1619
Assay Parameter Report element descriptions (i‑series)..................................................1632
Assay Parameter Report (Calculated) element descriptions ........................................... 1638
Calibration Details Report (Linear) element descriptions (c‑series).................................1642
Calibration Details Report (Potentiometric) element descriptions (c‑series)................... 1645
Calibration Details Report (Use Cal Factor Blank) element descriptions (c‑series)....... 1648
Calibration Details Report (Adjust) element descriptions (i‑series)..................................1651
Calibration Details Report (Full) element descriptions (i‑series)...................................... 1654
Calibration Details Report (Index) element descriptions (i‑series)................................... 1657
Calibration Summary Report element descriptions............................................................1660
Diagnostic History Report, Maintenance History Report element descriptions................ 1661
Exception List Report element descriptions....................................................................... 1664
Log Report element descriptions........................................................................................ 1666
Order List Report element descriptions..............................................................................1669
Procedure Report element descriptions............................................................................. 1671
QC Analysis Report element descriptions.......................................................................... 1673
QC Levey-Jennings Report element descriptions.............................................................. 1676
QC Summary Report element descriptions........................................................................ 1679
Reagent Status Report element descriptions.....................................................................1681

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Rerun List Report element descriptions..............................................................................1683

Result Details Report element descriptions....................................................................... 1685
Result List Report element descriptions............................................................................. 1689
Sample Laboratory Report element descriptions...............................................................1691
System Update Details Report element descriptions.........................................................1693
System Update List Report element descriptions.............................................................. 1696
User-Defined Maintenance Details Report element descriptions..................................... 1698
Glossary.................................................................................................... 1701

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Read me first
Foreword
Congratulations on becoming an operator of the Alinity ci‑series. The Alinity ci‑series has a small,
compact, and scalable design to help you adapt to day-to-day and long-term needs within your
laboratory. The system is supported by resourceful advocates consisting of dedicated
professionals who excel in engineering, medical technology, training, and service. As part of a
dedicated customer-training program, Abbott Laboratories will teach you how to operate,
maintain, and troubleshoot the system. We are dedicated to helping you achieve measurably
better health care with our resourceful advocates, harmonized systems, and intelligent insights
by providing you with the highest quality and most reliable instrumentation. We look forward to
serving your needs in any way possible.
Related information...
What's new, page 14
General safety information, page 18
System security, page 19
Customer service, page 20
Intended use, page 21
Proprietary statement, page 22
Disclaimers, page 23
Alinity ci‑series warranty statement for USA customers only, page 25
Alinity ci‑series agency approvals, page 26
Intellectual Property statement, page 27
Key to symbols, page 28

80000071-105 - 2018-09-10
What's new Read me first
What's new
The following new features and changes were introduced in Alinity ci‑series System Software
Version 2.6.0.
Improved search functionality in the Alinity ci‑series Operations Manual
System documentation procedure Search for a term, page 50 has been updated to reflect the
improved search functionality in the Alinity ci‑series Operations Manual.
Distance alert
New configuration items have been added for the distance alert. The operator can enable or
disable specific notifications that cause the distance alert to illuminate. See the following
updated topics:
• Distance alert, page 68
• Distance Alert screen, page 245
• Distance Alert screen element descriptions, page 246
• Configure distance alert settings, page 248
Induction heating
The induction heater wash cup is an optional hardware component that is available for the
Alinity i processing module for the sample pipettor. The sample probe is heated and the wash
buffer is warmed as it flows through the probe to provide improved washing. The induction
heating hardware supports the future launch of i‑series assays. See the following updated and
new topics:
• Pipetting hardware (Alinity i), page 122
• Induction heater wash cup (Alinity i), page 126
• 2630 Manual Wash Cup Cleaning (i‑series), page 870
• 1201 Induction Heater Test (i‑series), page 902
Pre-Trigger Solution stability
The Pre-Trigger Solution onboard stability has been reduced from 28 days on the system to
16 days on the system. See the following updated topics:
• Bulk solutions (i‑series), page 151
• Solutions used in daily operations (i‑series), page 578

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Read me first What's new
Alinity c‑series reagent cartridges with empty bottles
Revised c‑series reagent cartridges with empty bottles are available. References to the reagent
cartridges have been updated to reflect the new options:
• c‑series Reagent Cartridge, Black (Large), LN 04S1750
• c‑series Reagent Cartridge, Clear (Large), LN 04S1740
See the following updated topics:

• Reagent cartridge with empty bottles (c‑series), page 158
• Prepare sample diluents and user-defined reagents (c‑series), page 627
• 4109 Probe Alignment Test (c‑series), page 880
• 4213 Liquid Level Sense Test (c‑series), page 884
• 4703 Reagent Supply Center Test (c‑series), page 887
• Consumable list numbers (c‑series), page 1531
Water and liquid waste specifications and requirements
The incoming water quality specification of the temperature has been updated from 15°C (59°F)
to 37°C (98.6°F) to match the environmental specification of the temperature during operation,
which is 15°C (59°F) to 30°C (86°F).
See Water and liquid waste specifications and requirements, page 459.
New printer drivers
Kyocera Classic Universal Driver PCL6 and Kyocera Classic Universal Driver PCL6 (A4) were
added as available printer drivers.
See Computer and interface specifications, page 462.
Blank calibrator set name
For c‑series assays that use a blank calibrator set with a different lot number than the calibrator
set lot number, the blank calibrator set name, blank calibrator lot number, and expiration date
are displayed in the system software and on reports. The new blank calibrator set configuration
supports the future launch of c‑series assays. The blank calibrator set is not available for user-
defined assays. See the following updated topics:
• Assay Parameters screen, Calibration tab element descriptions (c‑series photometric), page
266
• Edit general settings of assay parameters (c‑series photometric), page 286
• Prepare and load calibrator and control vials into vial racks for onboard storage, page 624
• Prepare and load calibrator and control vials into vial racks for immediate use, page 646

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What's new Read me first
• Automated calibration ordering, page 656

• Create Order screen, Calibration tab element descriptions, page 679
• Create a calibration order, page 688
• Calibration Status Details screen element descriptions, page 800
• Assay Parameter Report element descriptions (c‑series), page 1619
• Calibration Details Report (Linear) element descriptions (c‑series), page 1642
Displayed and printed calibrator concentration values
The c‑series and i‑series calibrator concentration values are now displayed in the configured
assay result units instead of the default result units. Assays that reference the calibration of
another assay, such as c‑series photometric assays with the use cal factor blank calibration
method and i‑series assays with the reference calibration method, display calibrator
concentrations in the result units of the reference assay. See the following updated topics:
• Calibration Status Details screen element descriptions, page 800
• Calibration Details Report (Linear) element descriptions (c‑series), page 1642
• Calibration Details Report (Use Cal Factor Blank) element descriptions (c‑series), page 1648
• Calibration Details Report (Adjust) element descriptions (i‑series), page 1651
• Calibration Details Report (Full) element descriptions (i‑series), page 1654
Maintenance procedures
The frequency of the following Alinity c maintenance procedures has changed from quarterly to
triannual and the procedure numbers have changed to reflect the new category:
• 5833 Change 1 mL Syringes (c‑series), page 863
• 5834 Check and Change ICT Check Valves (c‑series), page 864
• 5835 Check and Clean High-Concentration Waste Sensor (c‑series), page 864
When software version 2.6.0 is installed on the system, the time interval tracking for the new
triannual maintenance procedures will be reset. To ensure efficient tracking of the maintenance
interval during the transition from the quarterly procedures to the triannual procedures, the
operator may want to perform the triannual procedures after software version 2.6.0 has been
installed.
NOTE: Maintenance procedure 5835 Check and Clean High-Concentration Waste Sensor
(c‑series), page 864 is required only if the high-concentration waste bottle is installed on the
system.
Maintenance procedure 2630 Manual Wash Cup Cleaning (i‑series), page 870 has been updated
to reflect the new induction heating hardware.

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Read me first What's new
Diagnostic procedures
The following new diagnostic procedures were added:

• 4113 Pipettor Check (c‑series), page 881
• 1201 Induction Heater Test (i‑series), page 902
• 1209 Empty Bulk Solution Reservoirs (i‑series), page 905
Read me first, page 13

80000071-105 - 2018-09-10
General safety information Read me first
General safety information

Before operating the Alinity ci‑series, you should read and understand the safety information in
this manual.
For information about actions or conditions that can affect system and assay performance,
carefully review Operational precautions and limitations, page 809.
To become familiar with safety icons on the instrument and in this manual that indicate
potentially hazardous situations, review Hazards, page 817. Comply with the hazard and safety
information to minimize the potential for harm to personnel and damage to the laboratory
environment.
These two sections of the manual contain supplemental information. Do not use the
supplemental information to supersede workplace safety requirements. Review any significant
differences between the supplemental information and the workplace safety requirements with
management or a workplace safety representative.

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Read me first System security
System security
Abbott Laboratories is committed to the security of the Alinity systems and reducing
cybersecurity risks associated with our medical devices.
Abbott Laboratories recognizes the importance of incorporating cybersecurity considerations
early and throughout our product design and development process. Our cybersecurity controls
were designed, developed, and implemented based on leading practices, regulatory guidance,
and government agencies.
Although we have designed the Alinity systems with cybersecurity controls, our customers also
play a vital role in protecting information security:
• Use of good laboratory practices and adherence to applicable regulations is recommended
at all times.
• The system should be installed in a secure location.
• Only authorized users should have access to the system because the system may contain
protected health information (PHI) or sensitive data.
• Although Alinity systems incorporate cybersecurity risk mitigation controls relating to network
connectivity, each system should be installed on a secure network that adheres to best
practices from a network security perspective to prevent unauthorized access to data
transmission between the Alinity system and external systems, such as a printer or host.
• Alinity systems also incorporate cybersecurity risk mitigation controls relating to connecting
USB storage devices. Reports or other data exported to USB storage devices should be
controlled with appropriate laboratory practices.

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Customer service Read me first
Customer service
For questions about the Alinity ci‑series, contact the local representative or find country-specific
contact information at abbottdiagnostics.com.

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Read me first Intended use
Intended use
The Alinity ci‑series is intended for In Vitro diagnostic use only.
The Alinity ci‑series has a scalable design to provide full integration of clinical chemistry and
immunoassay analysis. The Alinity ci‑series includes a clinical chemistry module and an
immunoassay module, each performing all sample processing activities, and a system control
module to provide a single user-friendly interface. Each system can be customized by combining
one or more sample processing modules, in multiple configurations, with a system control
module to form a single workstation.
The Alinity c processing module is a fully automated chemistry analyzer allowing random and
continuous access, as well as priority and automated retest processing using photometric and
potentiometric detection technology. The Alinity c processing module uses photometric detection
technology to measure sample absorbance for the quantification of analyte concentration and
uses potentiometric detection technology to measure the electrical potential in a sample. In
addition, the Alinity c processing module uses an integrated chip technology (ICT) module to
measure potentiometric assays (electrolytes).
The Alinity i processing module is a fully automated immunoassay analyzer allowing random and
continuous access, as well as priority and automated retest processing using chemiluminescent
microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the
presence of antigens, antibodies, and analytes in samples.

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Proprietary statement Read me first
Proprietary statement
The Alinity ci‑series software programs and system documentation are protected by copyright
(©2016, 2018 Abbott Laboratories, Abbott Park, Illinois). All rights are reserved.
The software and manual were developed solely for use with the Alinity ci‑series as specified in
the operating instructions.
The information, documents, and related graphics published herein (the "Information") are the
sole property of Abbott Laboratories. Permission to use the Information is granted, provided that:
• the copyright notice appears on all copies;
• use of the Information is for operation of ABBOTT products by Abbott trained personnel or
informational use only;
• the Information is not modified in any way; and
• no graphics are used separate from accompanying text.
Each person assumes full responsibility and all risks arising from use of the Information herein.
The Information is presented "AS IS" without warranties, either express or implied, and may
include technical inaccuracies or typographical errors. Abbott Laboratories reserves the right to
make additions, deletions, or modifications to the Information at any time without any prior
notification.
Portions of the Alinity ci‑series software may include open source or third party software as
further explained in the Software License Attributions document, which can be accessed on the
Utilities screen.
7-Zip copyright ©1999-2016 Igor Pavlov

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Read me first Disclaimers
Disclaimers
All samples (printouts, graphics, displays or screens, etc.) are for information and illustration
purposes only and shall not be used for clinical or maintenance evaluations. Data shown in
sample printouts and screens do not reflect actual patient names or test results.
The Information was developed to be used by Abbott Laboratories-trained personnel, by other
persons knowledgeable or experienced with the operation and service of the product identified,
under the supervision and with cooperation from Abbott Laboratories technical support or service
representatives.
In no event shall Abbott Laboratories or its affiliates be liable for any damages or losses incurred
in connection with or arising from the use of the information by persons not fully trained by
Abbott Laboratories.
No confidential relationship shall be established in the event that any user of the Information
should make any oral, written or electronic response to Abbott Laboratories (such as feedback,
questions, comments, suggestions, ideas, etc.). Such response and any information submitted
therewith shall be considered non-confidential, and Abbott shall be free to reproduce, publish or
otherwise use such information for any purposes whatsoever including, without limitation, the
research, development, manufacture, service, use, or sale of products incorporating such
information. The sender of any information to Abbott is fully responsible for its content, including
its truthfulness and accuracy and its non-infringement of any other person's proprietary rights.
Abbott Laboratories is not engaged in rendering medical advice or services.
Updates to the Information may be provided in either paper or electronic format. Always refer to
the latest documents for the most current information.
Master Table of Contents and / or Index - Incremental manual updates may cause the Master
Table of Contents or Master Index page numbering to change.
No part of this media may be reproduced, stored, retrieved, or transmitted in any form or by any
means without the prior written permission of Abbott Laboratories.
Data Usage Statement for AbbottLink
Data collection:
Abbott's AbbottLink software only collects operational and instrument data. It does not gather or
access patient, sensitive health or other identifiable personal information ("Personal Data").
Use of data:
AbbottLink is intended to transmit connected systems operational data, which may be used by
Abbott, and third parties providing related services and products, for troubleshooting, complaint
investigation, performance monitoring, product improvement, research, development, inventory
management, usage analytics, billing and other related purposes. In addition, AbbottLink may be
used to send system updates, to provide remote service and to facilitate Abbott's delivery of third
party services and products to Customer. The terms and conditions for Customer's use of such

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Disclaimers Read me first
third party services and products are to be provided to Customer separately by the applicable
third parties.
No Personal Data is transferred or accessed for company use.
Data privacy assurance:
All Personal Data is removed from operational data prior to AbbottLink retrieval. It is important
that our customers avoid entering Personal Data in any SID (Sample Identification) or comments
fields.
During Remote Support Instrument Screen Sharing, data is accessed and transferred on the
basis of consent provided by the user at the point of each individual screen-sharing event.
Please refer to the form of consent, displayed on your analyzer screen, when taking advantage
of this service.

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Read me first Alinity ci‑series warranty statement for USA
customers only
Alinity ci‑series warranty statement for USA

customers only
Abbott Laboratories warrants new instruments sold by Abbott Diagnostics Division to be free from
defects in workmanship and materials during normal use by the original purchaser. This warranty
shall continue for a period of one year from the date of shipment to the original purchaser, or
until title is transferred from the original purchaser, whichever occurs first (the "Warranty
Period").
If any defects occur during the Warranty period, contact your Abbott Customer Service
Representative immediately, and be prepared to furnish information including the serial number,
the model number, and pertinent details concerning the defect.
This Warranty does not cover defects or malfunctions which: (1) are not reported to Abbott
during the Warranty Period and within one week of occurrence; (2) result from chemical
decomposition or corrosion; (3) are caused primarily by misuse, alteration, damage or failure to
comply with any requirements or instruction contained in the applicable Abbott Operations
Manual (including the substitution of any reagent not authorized by Abbott); or (4) result from
maintenance, repair, or modification, performed or attempted by personnel not authorized by
Abbott without Abbott's authorization.
Abbott's liability for all matters arising from the supply, installation, use, repair, and maintenance
of the instrument, whether arising under this Warranty or otherwise, shall be limited solely to the
repair or (at Abbott's sole discretion) replacement of the instrument or of components thereof.
Replaced parts shall become the property of Abbott Laboratories. In no event shall Abbott be
liable for injuries sustained by third parties.
The ICT module Warranty is 20,000 samples or three months post-installation, whichever occurs
first.
The cuvette warranty is one year post-installation.
EXCEPT AS EXPRESSLY PROVIDED ABOVE, ABBOTT LABORATORIES HEREBY DISCLAIMS
ALL REPRESENTATIONS AND WARRANTIES, WHETHER EXPRESS OR IMPLIED, CREATED BY
LAW, CONTRACT OR OTHERWISE, INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE OR NON-INFRINGEMENT.
IN NO EVENT SHALL ABBOTT LABORATORIES BE LIABLE FOR ANY INDIRECT, SPECIAL,
PUNITIVE, CONSEQUENTIAL OR INCIDENTAL DAMAGES (INCLUDING WITHOUT LIMITATION
LOST REVENUES, PROFITS, OR DATA) ARISING FROM OR IN CONNECTION WITH THE USE
OF THE INSTRUMENT, REGARDLESS OF WHETHER ABBOTT LABORATORIES HAS BEEN
ADVISED AS TO THE POSSIBILITY OF SUCH DAMAGES.

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Alinity ci‑series agency approvals Read me first
Alinity ci‑series agency approvals

The Alinity c processing module and the Alinity i processing module have been tested and found
to comply with the following agency standards and European Union (EU) directives:
• UL 61010-1 Safety Requirements for Electrical Equipment for Measurement, Control, and
Laboratory Use - Part 1: General Requirements
• IEC/EN 61010-1 Safety Requirements for Electrical Equipment for Measurement, Control,
and Laboratory Use - Part 1: General Requirements
• CAN/CSA-C22.2 No. 61010-1 Safety Requirements for Electrical Equipment for
Measurement, Control, and Laboratory Use - Part 1: General Requirements
• IEC/EN 61010-2-101 Safety requirements for electrical equipment for measurement, control
and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical
equipment
and laboratory use - Part 2-081: Particular requirements for automatic and semi-automatic
laboratory equipment for analysis and other purposes
and laboratory use - Part 2-010: Particular requirements for laboratory equipment for the
heating of materials
• Directive 2012/19/EU: Waste Electrical and Electronic Equipment (WEEE)
• Directive 2011/65/EU: Restriction of the Use of Certain Hazardous Substances in Electrical
and Electronic Equipment (RoHS 2)
• Directive 98/79/EC: In Vitro Diagnostic (IVD) Medical Devices
• IEC/BS EN 61326-1 Electrical equipment for measurement, control and laboratory use -
EMC requirements - Part 1: General requirements
• IEC/BS EN 61326-2-6 Electrical equipment for measurement, control and laboratory use -
EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical
equipment
Legal Manufacturer Abbott GmbH & Co. KG

Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580

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Read me first Intellectual Property statement
Intellectual Property statement

The green and blue striping, ALINITY, and related brand marks are trademarks of Abbott
Laboratories in various jurisdictions.
Other trademarks are the property of their respective owners. No use of any Abbott trademark,
trade name, or trade dress may be made without the prior written authorization of Abbott
Laboratories, except to identify the product or services of Abbott Laboratories.
For U.S. patent information, see abbott.us/patents.

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Key to symbols Read me first
Key to symbols
The following symbols are used on Alinity ci‑series labels and labeling.
Harmonized symbols
Directive 2002/96/EC
Symbol Description
WEEE: Waste Electrical and Electronic Equipment
NOTE: Indicates that the item needs to be disposed
of in a separate waste collection for electrical and
electronic equipment and must not be disposed of
in the general waste or trash.
IEC 61010-1
Symbol Description
Caution: Consult accompanying documents
Caution: Hot surface
Caution: Possibility of electric shock
Off
On
IEC 61010-2-101
Symbol Description
Caution: Biological RISKS
ISO 3287, ISO 3767-1, ISO 7296-1/Amd 1, ISO 11192

Symbol Description
Interior light

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Read me first Key to symbols
ISO 15223-1
Symbol Description
Consult operating instructions
Date of manufacture
Manufacturer
Temperature limitation
Use by/Expiration date
Authorized Representative in the European

Community
Batch code/Lot number
Catalog number/List number
In Vitro Diagnostic Medical Device
Serial number
Nonharmonized symbols
Symbol Description
Caution: Probe stick hazard
Disconnect Mains Plug
Priority
UL Recognized Component Mark
Acid Wash

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Symbol Description
Alkaline Wash
Concentrated Wash Buffer
Detergent A
Detergent B
Distributed by
Distributed in the USA by
For use with
ICT Reference Solution
Kit
Manufactured by
Manufactured for
Pre-Trigger Solution
Produced by
Produced for Abbott by
Product of Japan
Product of Singapore
Product of USA
Quantity
Reaction vessels
Revision
Sample cups
Sequence number
Trigger Solution

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Read me first Key to symbols
Symbol Description
Unit
Wash buffer
Water Bath Additive

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NOTES

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System documentation
Introduction
The Alinity ci‑series Operations Manual provides complete instructions for the use and
maintenance of the Alinity ci‑series and its modules and components.
Learning to use the operations manual helps to save time, avert trouble, and confidently operate
the system.
Organization of the operations manual, page 34
Conventions for the operations manual, page 36
Operations manual description, page 37
Operations manual use, page 45
Procedure map description, page 52

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Organization of the operations manual System documentation
Organization of the operations manual

Section Description
Read me first • General safety information
• Customer service contact information
• Intended use of the system
System documentation • Content organization and conventions
• Use of the operations manual
Section 1: Use or function • Hardware overview
• Software overview
• Required consumables
• Required accessories
Section 2: Installation procedures and special • System installation and relocation
requirements • System configuration
Section 3: Principles of operation • Detection technology
• How the system translates measurements into
results
Section 4: Performance characteristics and System specifications and requirements
specifications
Section 5: Operating instructions Procedures for routine system operation
Section 6: Calibration procedures Procedures for calibration
Section 7: Operational precautions and limitations Operational requirements, precautions, and
limitations to ensure optimal operator safety and
accurate test results
Section 8: Hazards Hazard and safety information
Section 9: Service, maintenance, and diagnostics • Procedures for maintenance and diagnostics
• Description of maintenance and diagnostic
procedures
• Procedures for component replacement
Section 10: Troubleshooting • Troubleshooting basics
• Probable causes and corrective actions for
message codes and observed problems
Appendices Refer to the appendices for the following
information:
• Verification of assay claims
• List numbers
• Assay applications (c-series photometric)
• Printed report element descriptions
Revision history History of revisions to the operations manual
Glossary Alphabetical listing of terms that are used in the
operations manual

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System documentation Organization of the operations manual
Section Description
Index Alphabetical listing of subject matter with
references to the location of information
System documentation, page 33

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Conventions for the operations manual System documentation
Conventions for the operations manual

Conventions are a set of defined standards that are used to communicate meaning in an
expected manner.
Table 1: Text conventions
Description Use
Italic font style Indicates a reference to related information.
Bold font style Emphasizes key words in procedures. For example,
in the numbered steps, bold font style is applied to
the following elements:
• Toolbar, icon, and menu items
• Buttons
• Commands
• Lists and tabs
• Dialog box titles and options
Numbers in brackets (for example, [1] and [2]) Reference specific areas of a graphic.
Table 2: Content conventions
Description Use
Safety symbols and the CAUTION signal word Identify activities that expose the operator to
potentially dangerous conditions.
IMPORTANT signal word Advises the operator to comply with precautions to
prevent a negative impact on system operations or
results.
NOTE signal word Provides information that is relevant to the topic
content.
Related information list Provides references at the end of a topic that are
related to the topic.
Table 3: Graphic conventions
Description Use
Numerical references on graphics Indicate items in a graphic that are described in the
legend.

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System documentation Operations manual description
Operations manual description

The operations manual is designed to be the quickest and most accurate resource for
informational needs. It is accessed from the system software.
Figure 1: Operations manual
Legend:
1. Title bar: Displays the title of the topic
2. Toolbar: Provides elements for navigation
3. Navigation pane: Provides an area to browse the operations manual content
4. Topic pane: Displays the topic content
5. Close button: Closes the operations manual
Toolbar, page 38

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Operations manual description System documentation
Navigation pane, page 38

Topic pane, page 43
Toolbar
The toolbar contains navigation elements and a Print button.
Figure 2: Toolbar
Legend:
1. Home link
2. Search box
3. Procedure Map button
4. Toggle TOC button
5. Back and Forward buttons
6. Previous Topic and Next Topic buttons
7. Print button
Navigation pane
The navigation pane provides the primary navigation functionality. It provides an area to browse
the topic content by using the Contents, Index, Glossary, or Search tab.

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Figure 3: Navigation pane
Contents tab, page 39
Index tab, page 41
Glossary tab, page 41
Search tab, page 42
Contents tab
The Contents tab is an element in the navigation pane that displays the table of contents, which
shows how information in the operations manual is organized. Topics are identified by a Book
icon or a Page icon.

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Figure 4: Contents tab
Legend:
1. Book icon (closed): Indicates that a list of subtopics is collapsed
2. Book icon (open): Indicates that a list of subtopics is expanded
3. Page icon: Indicates that no subtopics are available

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Index tab
The Index tab is an element in the navigation pane that displays an alphabetical list of all index
entries in the operations manual. Entries are sorted by subject and relevance and include terms
for all experience levels and informational types that range from general to specific.
Figure 5: Index tab
Glossary tab
The Glossary tab is an element in the navigation pane that displays an alphabetical list of terms
with definitions for those terms.

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Figure 6: Glossary tab
Search tab
The Search tab is an element in the navigation pane that displays a list of search results. The
search results are topic titles in the operations manual that are associated with a search term in
the Search box.

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Figure 7: Search tab
Legend:
1. Search tab
2. Search box
Topic pane
The topic pane is the area under the toolbar that displays topic content. The topic content may
contain navigation elements (for example, hypertext and image maps) and multimedia.

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Figure 8: Topic pane
Legend:
1. Breadcrumbs: Provide a trail of topic links to show the hierarchy of topics that were previously
accessed
2. Topic content: Provides information about the system
3. Related information: Provides links to related topics

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System documentation Operations manual use
Operations manual use

The operations manual is designed for quick access to information needed to:
• Understand the concepts behind system operation and performance.
• Accomplish a task.
• Recover from a mistake.
• Troubleshoot a problem.
Access the operations manual, page 45
Display and use the procedure map, page 46
Use the table of contents, page 46
Scroll through a topic or the table of contents, page 46
Play an animation, page 47
Access the related information, page 48
Use breadcrumbs to access a topic, page 48
Redisplay a topic, page 49
Page through the content, page 49
Use the Toggle TOC button, page 49
Use the index, page 49
Use the glossary, page 50
Search for a term, page 50
Resize, move, and close the operations manual, page 50
Print a topic from the operations manual, page 51
Access the operations manual

Perform this procedure to display the home page of the operations manual or the content
specific to an active screen, a flyout, or a message code.
• On the menu bar, tap System, and then tap Operations Manual (Help).
As an alternative step, tap the Help button at the top of the active screen.

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Operations manual use System documentation
Display and use the procedure map

Perform this procedure to view a list of procedures that are related to the performance of a
specific task and to display the instructions associated with each procedure.
1. On the toolbar, tap the Procedure Map button .
2. To display a list of related tasks, tap a category on the procedure map that is displayed in
the topic pane.
3. In the expandable list of related tasks for the category, tap a task with a Right Arrow button
.
The Right Arrow button changes to a Down Arrow button and displays a list of subtasks
or procedures.
4. To display a procedure, tap the procedure.
5. To return to the procedure map, tap the Procedure Map button.
Use the table of contents

Perform this procedure to view a list of topic titles in the operations manual and to display
associated topic content.
1. In the navigation pane, tap the Contents tab.
2. To expand or collapse the list of topic titles, tap a Book icon .
3. At the right side of the navigation pane, slide the scroll bar to view the topic titles.
4. To display the topic content in the topic pane, tap a topic title.
Scroll through a topic or the table of contents

Perform this procedure to move through content in a topic or to move through the table of
contents.
• In the topic pane or in the navigation pane, drag the scroll box up or down.
The scroll box indicates the position in the topic or in the table of contents.

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Figure 9: Scroll bars
Legend:
1. Navigation pane scroll bar
2. Topic pane scroll bar
Play an animation
The animation toolbar plays, pauses, and stops animations. It also can be used to seek a
specific location in an animation and to switch to a full-screen display.
Figure 10: Animation toolbar

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Legend:
1. Play button
2. Seek button
3. Full Screen toggle button
Perform this procedure to play an animation.

1. At the bottom of the image, tap the Play button.
The animation plays and the Play button changes to a Pause button .
NOTE: When a mouse is used to start an animation and the cursor is moved away from the
toolbar, the toolbar is not displayed. Move the cursor below the animation to display the
toolbar again.
2. To specify the playback position of the animation, tap a point on the timeline to move the
Seek button to that position.
3. To display the animation in full-screen mode, tap the Full Screen toggle button.
4. To restore the animation to its original size, tap the Full Screen toggle button again.
Access the related information

Perform this procedure to access the related information in a topic.
1. In the topic pane, tap a related information hypertext link.
2. To return to the last topic that was viewed, tap the related information hypertext link for the
topic (or tap the Back button ).
Use breadcrumbs to access a topic

Perform this procedure to access a topic in a breadcrumb trail. As topics are selected in the
navigation pane, a trail of the selected topics, or breadcrumbs, is displayed at the top of the
topic pane.
• At the top of the topic pane, tap a topic breadcrumb.
NOTE: Topic breadcrumbs display associated topic content. The Home link displays the home
page of the operations manual.

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Redisplay a topic
Perform this procedure to display a topic that is viewed in the active Help session.
1. To display the last topic that was viewed, tap the Back button .
2. To display the next topic in a previously displayed sequence of topics, tap the Forward
button .
Page through the content

Perform this procedure to move through a sequence of topics similar to the turning of pages of a
book.
1. On the Contents tab, tap a topic to display its content in the topic pane.
2. On the toolbar, tap the Previous Topic button or the Next Topic button .
NOTE: The Previous Topic button is unavailable for the first topic in the manual. The Next
Topic button is unavailable for the last topic in the manual.
Use the Toggle TOC button

Perform this procedure to hide the navigation pane of the operations manual. The navigation
pane contains the table of contents (TOC).
1. To hide the navigation pane, tap the Toggle TOC button .
2. To display the navigation pane, tap the Toggle TOC button again.
Use the index

Perform this procedure to view index entries and to display associated topic content.
1. In the navigation pane, tap the Index tab.

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2. At the right side of the navigation pane, slide the scroll bar to view index headings (italic
font style) and index entries (plain font style).
3. To display the topic content in the topic pane, tap an index entry.
Use the glossary

Perform this procedure to view glossary terms and to display associated definitions.
1. In the navigation pane, tap the Glossary tab.
2. At the right side of the navigation pane, slide the scroll bar to view the glossary terms.
3. To display a definition in the topic pane, tap a glossary term.
Search for a term

Perform this procedure to search the operations manual.
1. On the toolbar, tap the Search box.
2. With the virtual keyboard, type one or more search terms.
3. Tap the Search icon .
In the Search tab, results are ranked according to the frequency of the search term or
terms found in each topic. Topics that include all the search terms are ranked higher than
topics that contain only some of the search terms. In addition, topics that contain a search
term in the title of the topic are ranked higher than topics that contain a search term in the
body of the topic.
4. In the list of search results on the Search tab, tap a topic title.
In the topic pane, each word of the search term is highlighted in the topic because each
word of the search term is treated individually.
Resize, move, and close the operations manual

Perform this procedure to change the size and the position of the operations manual and to
close the manual.

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1. To enlarge the manual to full-screen mode, at the upper-right corner of the manual, tap the
Maximize button .
2. To restore the manual to its original size and position, tap the Restore Down button .
3. To resize the navigation and topic panes of the manual, drag the divider handle between
the panes toward the left edge or the right edge.
4. To change the height of the manual, drag the top edge or the bottom edge.
5. To change the width of the manual, drag the left edge or the right edge.
6. To move the manual, drag the title bar.
7. To close the manual, tap the Close button .
Print a topic from the operations manual

Perform this procedure to print a topic that is displayed in the topic pane.
1. On the toolbar, tap the Print button .
2. In the Print window, tap Print.
Clean and decontaminate the monitor, page 874

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Procedure map description System documentation
Procedure map description

The procedure map is an image map that displays categories of laboratory-related activities and
provides links to lists of tasks and procedures. The procedure map is used to quickly access
step-by-step instructions to help perform primary laboratory procedures.
Figure 11: Procedure map
Legend:
1. Procedure Map button: Provides access to tasks and procedures that are grouped by categories
2. Sample processing: Provides access to procedures used to prepare for system operation, to order
tests, to load and process samples, to review results, and to print reports
3. Quality control: Provides access to procedures used to review quality control data and to print quality
control reports
4. Manage data: Provides access to procedures used to manage system data
5. Help on Help: Provides access to procedures that describe how to use the operations manual
6. Maintenance: Provides access to procedures used to perform maintenance, to approve maintenance
logs, and to print reports

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System documentation Procedure map description
7. Troubleshooting: Provides access to procedures used to review system logs, to perform diagnostics,
to replace components, and to print diagnostic reports
8. Setup: Provides access to procedures used to configure and view settings for the system, assays,
quality control, and calibration, and to print reports
9. Calibration: Provides access to procedures used to calibrate assays
Procedure map task lists, page 53
Procedure map task lists

Task lists are topics that are accessed from the procedure map. Each topic contains an
expandable list of tasks that are related to a procedure map category or a laboratory-related
activity. Each task has a list of links to related procedures.

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Procedure map description System documentation
Figure 12: Procedure map task list
Legend:
1. Task list item that is collapsed
2. Task list item that is expanded
Procedure map description, page 52

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Section 1 Use or function
Introduction
The Alinity ci‑series of analyzers has a scalable design to provide full integration of multiple
clinical chemistry and immunoassay systems, all of which are controlled by one user-friendly
interface. This intuitive user interface provides a real-time display of each system’s status and a
to-do list of scheduled maintenance activities, which minimizes system interaction and optimizes
productivity. The Alinity ci‑series analyzers have also incorporated numerous features to prevent
and reduce errors and to increase walkaway time.
Alinity ci‑series hardware overview, page 56
Alinity system software overview, page 139
Required consumables, page 146
Required accessories, page 157
Automatic processing module activities, page 161
Operating instructions, page 479

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Alinity ci‑series hardware overview Section 1
Alinity ci‑series hardware overview

With the scalable design of the Alinity ci‑series family of analyzers, multiple processing modules
can perform all sample-processing activities and can be physically joined to form one
workstation or system. The processing modules determine the system configuration.
An Alinity ci‑series can be configured as:
• A chemistry system.
• An immunoassay system.
• A multimodule system that is a fully automated clinical chemistry assay and immunoassay
system.
A multimodule system includes multiple processing modules in different combinations of

chemistry and immunoassay processing modules. The Alinity c‑series can be configured to
process samples by using photometric and potentiometric methods. The Alinity i‑series uses the
chemiluminescent microparticle immunoassay (CMIA) method.
Use or function, page 55
Primary components of an Alinity ci‑series, page 56
Primary components of an Alinity ci‑series

An Alinity ci‑series, regardless of type, has three primary components:
System control Provides a common user interface among all Alinity products.
module (SCM)
Reagent and sample Transports reagents, samples, calibrators, and controls
manager (RSM) through the Alinity ci‑series. Each system has one primary
RSM regardless of the type and number of processing
modules.
Processing module Performs all sample-processing activities from sample

aspiration to final result reporting. The type and number of
processing modules determine the system configuration.

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Section 1 Alinity ci‑series hardware overview
Figure 13: Primary components of an Alinity ci‑series
Legend:
1. Processing module
2. RSM
3. SCM
Alinity ci‑series hardware overview, page 56
Procedure key, page 58
System control module (SCM), page 60
Reagent and sample manager (RSM), page 70
Processing modules, page 74
Optional components, page 136

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Procedure key
The procedure key provides access to the front and rear processing center covers of the
Alinity ci‑series processing modules and the reagent and sample manager by overriding the
interlocks for the processing module and system control module covers. The procedure key can
be used to perform maintenance procedures, diagnostic procedures, and component
replacement procedures.
Figure 14: Procedure key for the Alinity c

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Figure 15: Procedure key for the Alinity i

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Figure 16: Procedure key for the system control module
Descriptions of procedure key settings, page 845
Use a procedure key to perform a procedure, page 846
System control module (SCM)

The system control module (SCM) contains the following items:
• A user interface computer provides the software interface to the Alinity ci‑series and
provides an interface to a host or middleware computer.
• Hardware and software operate the reagent and sample manager (RSM).
• The power supply operates the user interface computer and the RSM.

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Figure 17: Front view of the SCM
Legend:
1. Adjustable monitor: Displays the user interface of the Alinity ci‑series and accepts on-screen
selections from the operator
2. Front SCM cover: Provides access to the RSM transport
NOTE: The front SCM cover is monitored by a sensor. If the cover is opened when the instrument
status of the RSM is Initializing or Running, the status transitions to Stopped.
3. SCM shelf: Provides a small shelf for the operator and provides access to remove the bar code
scanner
4. Bar code scanner: Provides a means to scan sample bar codes and supply bar codes
5. SCM front door: Provides access to the user interface computer and the procedure lock

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Figure 18: Rear view of the SCM
Legend:
1. Rear SCM cover: Provides access to the user interface computer power strip
2. Rear SCM upper access panel: Provides access to the Ethernet switch
3. Network connectors: Provide connections for external devices, such as the host interface and
AbbottLink
4. SCM main power breaker: Powers on and powers off the SCM power supply
5. Rear SCM lower access panel: Provides access to the power supply and RSM electronics
System control module (SCM) hardware components, page 63
Network connectors, page 64
Adjust the monitor position, page 65
Distance alert, page 68

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System control module (SCM) hardware components

Hardware components of the system control module (SCM) include the user interface hardware
and the reagent and sample manager (RSM) hardware.
Figure 19: SCM hardware components
Legend:
1. Bar code scanner: Scans sample bar codes and supply bar codes. When the SCM shelf is accessed,
the bar code scanner can be removed from the holder and can be used as a hand-held scanner.
2. Uninterrupted power supply (UPS): Provides a temporary, continuous flow of power to the user
interface (UI) computer during a power failure, which helps the operator to save data as necessary
and to perform a controlled shutdown procedure. (Optional component, not provided)
3. RSM X motor: Moves the RSM transport from position to position and from module to module.
4. Firewall: Provides data protection between the UI computer and the supporting communications
network.
5. UI power strip: Distributes AC power to the UI computer, the adjustable monitor, and the Ethernet
switch.
6. RSM embedded computer: Provides the software control for the RSM.

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7. Ethernet switch: Joins communication lines and facilitates the electronic transfer of information
among the UI computer and the processing module embedded computer and the RSM embedded
computer.
8. Network connectors: Provides connections for external devices, such as host interface and
AbbottLink.
9. SCM power supply: Provides AC power to the UI power strip and DC power to the RSM hardware.
10. UI computer: Provides the software interface to the Alinity ci‑series and provides an interface to a
host or middleware computer.
11. Water inlet: Provides a common area for the entrance and distribution of water for all processing
modules in a system.
12. Waste manifold: Provides a common waste outlet area for all processing modules in a system.
Network connectors
Network connectors provide connections from the user interface computer, through the firewall,
to the wide area network (WAN) and to other external devices, such as the host interface, a
middleware computer, and Alinity PRO.

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Figure 20: Network connectors
Legend:
1. WAN connector
2. Network connectors
Reseat network cables to the system control module (SCM), page 1469
Adjust the monitor position

Perform this procedure to adjust the height and angle of the monitor. The monitor support arm
has pivot points to adjust the monitor.

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Figure 21: Monitor pivot points
1. Position the monitor at a comfortable level to view.

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2. Adjust the monitor so that it is an arm's length from the face (38 cm to 76 cm or 15 in. to
30 in.).
3. Tilt the monitor slightly downward to eliminate any glare or reflection.

4. Tilt the monitor slightly backward to use the virtual keyboard.

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5. Move the monitor to the right side or the left side of the instrument as needed. The ideal
position depends on the instrument configuration and the location of the operator.
6. Use the attached handles to rotate the monitor to the rear of the instrument when required.
Distance alert
The distance alert is an optional component on the workstation that is used to identify instrument
conditions that require an operator response to maintain the optimal workflow.

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Figure 22: Distance alert
The distance alert illuminates one of three colors (red, amber, or green) based on the status of
the workstation.
The following list provides descriptions of each color. If multiple conditions are present, the
colors are illuminated in the following order:
Red (blinking) • The instrument status of one or more processing modules
in the workstation transitions from Running or Processing
to Stopped or Offline without an operator request to
transition the status.
• A critical alert message is generated and is displayed on
the user interface.
Red The instrument status of one or more processing modules in

the workstation is Running, Processing, or Pausing, and one
of the following conditions is present:

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• If the distance alert is configured for notifications, a red

badge is displayed on any icon on the menu bar.
• An alert message that has not been cleared is present in
the Alert Center.
Amber The instrument status of one or more processing modules in

the workstation is Running, Processing, or Pausing, and one
of the following conditions is present:
• If the distance alert is configured for notifications, an
amber badge is displayed on any icon on the menu bar
except the Results icon.
• If the distance alert is configured for exception
notifications, an amber badge is displayed on the Results
icon.
• A notification message that has not been cleared is
present in the Alert Center.
Green (blinking) The instrument status of one or more processing modules, but
not all modules, in the workstation is Running or Processing.
Green The instrument status of all processing modules in the

workstation is Running or Processing.
Distance alert off The distance alert is not illuminated when one of the following
conditions is present:
• The distance alert is disabled.
• The user interface computer is shut down.
• The instrument status of one or more processing modules
in the workstation is not Running, Processing, or Pausing.
Reagent and sample manager (RSM)

The reagent and sample manager (RSM) is a transport system used to load calibrators, controls,
specimens, reagents, and onboard solutions. The design of the RSM provides random and
continuous access to load and unload sample racks, calibration and control racks, and reagent
cartridges.
One primary RSM transports samples and reagents through an Alinity ci‑series regardless of the
type and number of processing modules.
The RSM performs the following functions:

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• Lifts racks and cartridges from the loading area and moves them past the bar code reader
• Positions racks and cartridges for the bar code reader to identify samples, reagents, and
solutions
• Moves racks and cartridges to the appropriate processing module or returns them to the
loading area
Figure 23: RSM components
Legend:
1. Sample positioner: Positions racks at the sample aspiration position. Each module has two sample
positioners. A rack exchange occurs between the loading area and one sample positioner while the
other sample positioner positions samples for aspiration.
2. RSM bar code reader: An imaging camera that reads bar code labels on samples, racks, and
cartridges.
3. RSM transport: Transports racks and cartridges from the loading area to be read by the bar code
reader and to be placed on the module-specific sample positioner or reagent positioner.
4. Loading area: Positions racks and cartridges for loading and unloading.

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Loading area, page 72
Status indicators, page 73
Reagent supply center (Alinity c), page 100
Reagent supply center (Alinity i), page 133
Loading area
The loading area holds racks and cartridges for routine and priority processing. Each processing
module includes one loading area.
Figure 24: Loading area
Legend:
1. Priority button: Temporarily assigns an RSM position as a priority position.
2. Priority position: Designated with a blue status indicator. Racks or cartridges inserted in this position
are processed before other positions.
3. Status indicators: Indicate the status of sample processing and when samples and reagents can be
accessed.
4. Tray: Holds racks and cartridges to load on the reagent and sample manager (RSM). Each tray holds
a maximum of five racks or cartridges. Empty trays may remain on the loading area to create five
positions to load racks or cartridges one at a time.

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5. Position: Holds one rack or cartridge. Each processing module has 25 positions.
6. Bay: Holds trays that are used to position racks and cartridges for assay processing. Each processing
module contains five bays.
Racks, page 157
Trays, page 158
Reagent kits and components, page 146
Status indicators
Three status indicators (blue, green, and amber) are located above each reagent and sample
manager (RSM) position to indicate the status of sample processing and when racks and
cartridges can be accessed.
Figure 25: Status indicators
The following list shows the position status:

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Indicators off No rack or cartridge is inserted in the position. [1]
Green (steady) The rack or cartridge is inserted but is not in process. The
rack or cartridge can be accessed. [2]
Amber (steady) The rack or cartridge is in process. The rack or cartridge

cannot be accessed. [4]
Green (blinking) Processing is completed. The rack or cartridge can be

accessed.
If a test is added or a rerun is scheduled before the rack is
removed from the loading area, the status indicator for the
position changes to amber and the rack cannot be accessed.
Amber (blinking) Unloading of a cartridge or vial rack is in process. The

position is reserved and is unavailable to load a rack or
cartridge.
Amber and green A bar code scan error or other error occurred. The rack or
(alternating) cartridge can be accessed.
Blue The RSM position is designated as a priority position. [3]
Unload trays from the reagent and sample manager (RSM), page 607
Processing modules
Processing modules perform all sample-processing activities from sample aspiration to final
result reporting.
Unless otherwise indicated, "processing module" is used generically throughout this manual to
refer to both types of modules.
Processing center interior lights, page 74
Processing module (Alinity c), page 76
Processing module (Alinity i), page 102
Processing center interior lights

Processing center interior lights are located on the top panel of the Alinity i and Alinity c. The
interior lights provide additional lighting when routine maintenance and system troubleshooting is
performed. With either the front processing center cover or the rear processing center covers

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opened the interior lights can be turned on. The interior lights are turned on by pressing the
interior light button located on the front edge of the top panel, indicated by the light icon if
present.
The interior lights come on at a preset level of intensity. The light intensity may be adjusted
through any of eight levels by pressing and holding either the front light button or the rear light
button. When the light intensity reaches either the lower extreme or upper extreme the light
intensity cycle will reverse. A single press to either the front light button or the rear light button
will turn off the interior light. Closing both the front processing center cover and the rear
processing center cover of a processing module will turn off the interior light. The power is
supplied to the interior light by the system control module so the interior light will work with the
processing module power turned off.
Figure 26: Processing center interior light button
Processing center (Alinity c), page 78
Processing center (Alinity i), page 105

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Processing module (Alinity c)

The Alinity c processing module is a chemistry analyzer that performs sample processing. The
processing module processes a maximum of 1350 photometric and potentiometric tests per hour
and has 70 positions in the reagent carousel at a controlled temperature.
Figure 27: Front view of the Alinity c processing module
Legend:
1. Front processing center cover: Provides access to the components that perform assay-processing
activities.
NOTE: The front processing center cover is monitored by two sensors. If the cover is opened during
Initializing status, Running status, or Processing status, the reagent and sample manager and the
processing module transition to Stopped status.
2. Bulk solution door: Provides access to the bulk solution storage area and the pump center.
3. Front electronics door: Provides access to the processing module electronics and the procedure lock.

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Figure 28: Rear view of the Alinity c processing module
Legend:
1. Rear processing center cover: Provides access to the components that perform assay-processing
activities.
NOTE: The rear processing center cover is monitored by a sensor. If the cover is opened when the
instrument status of the processing module is Initializing, Running, or Processing, the status
transitions to Stopped.
2. Rear access panel: Provides additional access to processing center components.
3. Rear lower access panel: Provides access to the water management unit.
4. Power supply panel: Provides access to the processing module power supply.
5. Processing module main power breaker: Powers on and powers off the power supply.
Supply and pump center (Alinity c), page 94

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Processing center (Alinity c)

The processing center is the main activity area of the processing module. Samples and reagents
are dispensed and mixed in a reaction carousel where assay processing is performed.
Figure 29: Processing center (Alinity c)
Legend:
1. Pipetting hardware: Aspirates and dispenses sample and reagents
2. Reaction carousel hardware: Positions the cuvettes for sample and reagent dispense, mixing,
photometric or potentiometric analysis, and cuvette washing
Pipetting hardware (Alinity c), page 78
Reaction carousel hardware (Alinity c), page 83
Pipetting hardware (Alinity c)

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Pipetting hardware aspirates and dispenses samples, reagents, and onboard solutions.
Figure 30: Pipetting hardware components (Alinity c)
Legend:
1. Sample pipettor (S): Aspirates and dispenses samples into cuvettes and transfers diluted samples
from one cuvette to another.
2. Reagent pipettors (R1 and R2): Aspirate and dispense reagents and onboard solutions into cuvettes.
The R1 pipettor also aspirates and dispenses diluents.
3. Wash cups (SW, WB, LASW, R1W, and R2W): Wash any fluid that remains from the interior and
exterior surfaces of probes.
Pipettors (Alinity c), page 79
Wash cups (Alinity c), page 81
Sample wash solution area (Alinity c), page 82
Pipettors (Alinity c)

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Pipettors detect, aspirate, transfer, and dispense samples and reagents into cuvettes. These
pipettor assemblies include a fluid sense and a pressure-monitoring system to help identify
aspiration errors. Three pipettors that have the following functions are located on the system:
• The sample pipettor (S) detects, aspirates, transfers, and dispenses samples into cuvettes.
It also transfers diluted samples from the cuvette that is used to make the dilution into the
cuvette that is used for the reaction.
• The reagent 1 pipettor (R1) detects, aspirates, transfers, and dispenses diluents, reagents,
and onboard solutions into cuvettes.
• The reagent 2 pipettor (R2) detects, aspirates, transfers, and dispenses reagents and
onboard solutions into cuvettes.
Figure 31: Pipettors (Alinity c)
Legend:
1. Sample pipettor
2. Reagent 1 pipettor
3. Reagent 2 pipettor

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Wash cups (Alinity c)

The Alinity c wash cups are active wash stations that use system water to clean the pipettors.
The system has five pipettor wash cups.
Figure 32: Wash cups (Alinity c)
Legend:
1. Sample wash cup (SW): Washes the fluid that remains from the probe exterior and interior between
samples to eliminate carryover.
2. Whole blood wash cup (WB): Washes the exterior of the sample probe before a whole blood sample
is dispensed into the cuvette.
3. Reagent 1 pipettor wash cup (R1W): Washes any fluid that remains from the probe exterior and
interior.
4. Reagent 2 pipettor wash cup (R2W): Washes any fluid that remains from the probe exterior and
interior.

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5. Laboratory automation system wash cup (LASW): Washes the fluid that remains from the sample
probe exterior and interior after whole blood samples to eliminate carryover. This wash cup is used
only on systems that are connected to a laboratory automation system (LAS).
Sample wash solution area (Alinity c)

The sample wash solution area stores sample onboard wash solutions that are used for the
SmartWash function and maintenance procedures. The area provides space for two sample
tubes in a removable sample wash solution holder.
Figure 33: Sample wash solution area (Alinity c)
Legend:
1. Sample wash solution holder
2. Detergent A
3. Acid Probe Wash

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Reaction carousel hardware (Alinity c)

The reaction carousel hardware components position the cuvettes for sample and reagent
dispense, mixing, photometric or potentiometric analysis, and cuvette washing.
Figure 34: Reaction carousel hardware (Alinity c)
Legend:
1. Mixers: Mix sample with reagent
2. ICT unit: Measures potentiometric assays (sodium, potassium, and chloride) by using integrated chip
technology (ICT)
3. Lamp: Provides the light source for photometric measurement
4. ICT high-concentration waste area: Receives liquid waste from the ICT unit
5. Cuvette washer: Washes and dries the cuvettes
6. Water bath overflow and waste area: Receives overflow from the water bath, excess water from the
sample pipettor, and liquid waste from the ICT Reference Solution cup

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7. Cuvette segments: Hold the cuvettes in the reaction carousel

8. Reaction carousel: Positions the cuvettes for sample processing
9. High-concentration waste pump: Works with the cuvette washer to aspirate waste from the cuvettes to
the optional high-concentration waste bottle or the drain
Reaction carousel (Alinity c), page 84
Cuvette segments (Alinity c), page 85
Lamp (Alinity c), page 86
Mixers (Alinity c), page 87
Cuvette washer (Alinity c), page 88
ICT unit (Alinity c), page 90
ICT high-concentration waste area (Alinity c), page 91
Water bath overflow and waste area (Alinity c), page 92
High-concentration waste pump (Alinity c), page 93
Reaction carousel (Alinity c)

The reaction carousel supports a variety of assay protocols and has 17 cuvette segments
surrounded by a 37°C water bath. The carousel rotates counterclockwise to position the cuvettes
at the following locations:
• Sample dispense
• Reagent 1 dispense
• Reagent 2 dispense
• ICT sample aspiration
• Mixing
• Photometric read position
• Diluted sample aspiration

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Figure 35: Reaction carousel (Alinity c)
Cuvette segments (Alinity c)

Cuvette segments suspend cuvettes in the reaction carousel. Each cuvette segment holds 11
cuvettes. The Alinity c processing module contains 17 segments for a total of 187 cuvettes in the
reaction carousel.

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Figure 36: Cuvette segment (Alinity c)
Lamp (Alinity c)
The lamp is an optical device that provides the light source for photometric assay measurement.

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Figure 37: Lamp (Alinity c)
Mixers (Alinity c)
The Alinity c processing module has two mixers that mix sample with reagent in the cuvette.
After each mixing operation, the exterior of the mixer is washed in the wash cup located beneath
the mixer.

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Figure 38: Mixers (Alinity c)
Legend:
1. Mixer 1: Mixes the sample with reagent 1 or a diluent
2. Mixer 2: Mixes the sample and reagent 1 mixture with reagent 2
Cuvette washer (Alinity c)

The cuvette washer is a device with eight nozzles that perform the following functions before
and after each cuvette is used. The nozzles are listed in order from right to left on the cuvette
washer:
Nozzle 1 Dispenses water and aspirates the sample and reagent

mixture to waste

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Nozzle 2 Dispenses Alkaline Wash to clean the cuvette and aspirates

the Alkaline Wash to waste
Nozzle 3 Dispenses Acid Wash to clean the cuvette and aspirates the
Acid Wash to waste
Nozzles 4 and 5 Dispense water to rinse the cuvette and aspirate the water to
waste
Nozzle 6 Dispenses water into the cuvette for the water blank
measurement, which ensures cuvette integrity
Nozzle 7 Aspirates the water that remains in the cuvette to waste
Nozzle 8 Dries the cuvette
Figure 39: Cuvette washer (Alinity c)

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ICT unit (Alinity c)

The integrated chip technology (ICT) unit has an ICT probe and an ICT module. It is used to
perform the indirect potentiometric analysis of sodium (Na+), potassium (K+), and chloride (Cl-).
Figure 40: ICT unit (Alinity c)
Legend:
1. ICT module: Measures electrolytes (Na+, K+, and Cl-) at a temperature of 37°C by using integrated
chip technology.
2. ICT probe: Connects to the ICT module in the ICT unit. The ICT probe aspirates the diluted sample
from the cuvettes or ICT Reference Solution from the ICT Reference Solution cup into the ICT
module for processing.
3. ICT Reference Solution cup: Located beneath the ICT probe when the ICT unit is in the home
position. It contains preheated ICT Reference Solution that is aspirated by the ICT probe and
measured by the ICT module. Sensors in the cup confirm that the cup fills completely and that
sufficient solution aspirates during measurement.

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Figure 41: ICT Reference Solution warming ring (Alinity c)
Legend:
1. ICT Reference Solution warming ring: A narrow metal tube located in the water bath. The warming
ring heats the reference solution to 37°C before the ICT Reference Solution cup is filled.
ICT high-concentration waste area (Alinity c)

Liquid waste from the ICT unit collects in a high-concentration waste compartment, and then the
waste is removed through the high-concentration waste tubing.

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Figure 42: ICT high-concentration waste area (Alinity c)
Legend:
1. ICT high-concentration waste area
Water bath overflow and waste area (Alinity c)

The water bath overflow and waste area is a waste collection compartment that receives
overflow from the water bath, excess water from the sample pipettor, and liquid waste from the
ICT Reference Solution cup.
Water from the sample pipettor and waste from the ICT Reference Solution cup collect in a low-
concentration waste compartment, and then the water and waste are removed through the low-
concentration waste tubing.

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Figure 43: Water bath overflow and waste area (Alinity c)
Legend:
1. Sample tubing: Delivers excess purified water from the sample pipettor into the low-concentration
waste compartment
2. ICT Reference Solution cup low-concentration waste tubing: Delivers liquid waste from the ICT
Reference Solution cup into the low-concentration waste compartment
High-concentration waste pump (Alinity c)

The high-concentration waste pump works with the cuvette washer to aspirate waste from the
cuvettes to the optional high-concentration waste bottle or the drain.

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Figure 44: High-concentration waste pump (Alinity c)
Supply and pump center (Alinity c)

The supply and pump center is the onboard storage area for processing module pumps, bulk
solutions, and sample and reagent syringes and drives.

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Figure 45: Supply and pump center (Alinity c)
Legend:
1. Bulk solution storage area: Provides the onboard storage for replacement bulk solution bottles
2. Sample and reagent syringes area: Houses the sample and reagent syringes and drives
3. Bulk solution reservoir area: Provides the onboard storage for the ICT Reference Solution, Alkaline
Wash, and Acid Wash that are in use
4. Pump center: Houses the processing module pumps
Pump center (Alinity c), page 95
Bulk solution storage area (Alinity c), page 97
Bulk solution reservoir area (Alinity c), page 98
Sample and reagent syringe area (Alinity c), page 99
Pump center (Alinity c)

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The pump center houses the processing module pumps. These pumps provide the pressure that
is needed to aspirate and dispense liquids into the appropriate components in the processing
center.
Figure 46: Pump center (Alinity c)
Legend:
1. Wash solution pump: Delivers diluted Alkaline Wash and Acid Wash solutions to the cuvettes during
daily operation and maintenance procedures.
2. ICT Reference Solution pump: Uses the syringe on the left side of the pump to deliver ICT Reference
Solution into the ICT Reference Solution cup. After the ICT Reference Solution is measured, the ICT
Reference Solution pump uses the syringe on the right side of the pump to drain the cup.
3. ICT aspiration pump: Uses the syringe on the right side of the pump to deliver samples or ICT
Reference Solution into the ICT module for measurement. After measurement is completed, the ICT
aspiration pump uses the syringe on the left side of the pump to aspirate waste from the ICT high-
concentration waste area to the high-concentration waste tubing.
4. ICT aspiration valve: Controls the direction of liquid flow while the ICT aspiration pump operates.

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Bulk solution storage area (Alinity c)

The bulk solution storage area, which is located on the bulk solution door, provides the onboard
storage for replacement bulk solution bottles. Bulk solutions from the replacement bottles fill
onboard bulk solution reservoirs. Each bottle has a unique keyed cap that locks into its
appropriate key slot in a bottle holder.
Figure 47: Bulk solution storage area (Alinity c)
Legend:
1. Alkaline Wash: Used by the cuvette washer to clean the cuvettes after sample analysis.
2. Acid Wash: Used by the cuvette washer to clean the cuvettes after sample analysis.
3. ICT Reference Solution: Aspirated and analyzed by the ICT module before and after each sample to
provide a reference potential that is used in result calculation.
4. Bottle release button: Releases a bulk solution cap from a bottle holder to remove and replace a bulk
solution bottle.

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5. Bottle holder: Stores a replacement bulk solution bottle. Contains a mechanism that pierces the bulk
solution septum.
Bulk solutions (c‑series), page 150
Bulk solution reservoir area (Alinity c)

The bulk solution reservoir area, which is located in the supply center, provides the onboard
storage for bulk solutions in use during assay processing. When onboard bulk solution reservoirs
are empty, bulk solutions from replacement bottles on the bulk solution door fill the reservoirs
without an interruption in system operation.
Figure 48: Bulk solution reservoir area (Alinity c)
Legend:
1. Alkaline Wash reservoir: Holds in-use Alkaline Wash solution.
2. Acid Wash reservoir: Holds in-use Acid Wash solution.
3. ICT Reference Solution reservoir: Holds in-use ICT Reference Solution.

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4. Reservoir bottle tray: Holds the bulk solution reservoirs. Slides out to access the bulk solution
reservoirs.
Sample and reagent syringe area (Alinity c)

The sample and reagent syringe area holds the sample and reagent syringes and drives. Each
drive supports a syringe that aspirates and dispenses samples, reagents, and onboard solutions.
Figure 49: Sample and reagent syringe area (Alinity c)
Legend:
1. Sample syringe: Aspirates and dispenses the sample
2. Reagent syringes 1 and 2: Aspirates and dispenses the reagent and onboard solutions

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Reagent supply center (Alinity c)

The reagent supply center provides cooled storage at a controlled temperature for reagent
cartridges, onboard solutions, sample diluents, and frequently used calibrators and controls.
Cartridges and vial racks are loaded on the reagent and sample manager (RSM) and are
transferred to the reagent positioner by the RSM transport.
Figure 50: Reagent supply center (Alinity c)
Legend:
1. Reagent carousel: Holds reagent cartridges and frequently used calibrators and controls. The
carousel rotates to provide reagent access to reagent 1 and reagent 2 pipettors.
2. Reagent positioner: Positions cartridges and onboard vial racks to load in the reagent carousel or
onto the loading area. When the reagent positioner is in the open position, the cartridge or rack can
be transferred to the loading area. When the reagent positioner is in the closed position, the cartridge
or rack can be transferred to the reagent carousel.
3. Reagent transport: Places cartridges and onboard vial racks in the reagent carousel or onto the
reagent positioner.

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Reagent carousel (Alinity c), page 101
Reagent carousel (Alinity c)

The reagent carousel is a rotating, circular device that performs the following functions:
• Holds a maximum of 70 bar-coded reagent cartridges, onboard solutions, sample diluents,
and vial racks in a cooled environment at a controlled temperature
• Rotates to position reagent cartridges and onboard solutions so that reagents or solutions
can be aspirated and dispensed
• Rotates to position vial racks for transfer to the sample positioner so that calibrators and
controls can be aspirated and dispensed
Figure 51: Reagent carousel (Alinity c)

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Legend:
1. Reagent segment: A section of the reagent carousel. The reagent carousel has two types of
segments and 12 total segments:
– Eleven segments can hold a maximum of six cartridges. Vial racks cannot be stored in these
segments.
– The twelfth segment contains the reagent carousel calibration target. This segment can hold a
maximum of four cartridges or vial racks.
The total capacity of the 12 segments is 70 cartridges.

2. Reagent position: A section of a reagent segment that holds one cartridge or vial rack.
3. Reagent carousel calibration target: A calibration target that is used to align the reagent pipettor and
the reagent transport to cartridges and vials.
Processing module (Alinity i)

The Alinity i processing module is an immunoassay analyzer that performs sample processing.
The processing module processes a maximum of 200 chemiluminescent microparticle
immunoassay (CMIA) tests per hour and has 47 positions in the reagent carousel at a controlled
temperature.

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Figure 52: Front view of the Alinity i processing module
Legend:
1. Front processing center cover: Provides access to the components that perform assay-processing
activities.
NOTE: The front processing center cover is monitored by two sensors. If the cover is opened during
Initializing status, Running status, or Processing status, the reagent and sample manager and the
processing module transition to Stopped status.
2. RV hopper cover: Provides access to the RV hopper to replenish reaction vessels.
3. Bulk solution door: Provides access to the bulk solution storage area and the RV waste storage area.
4. Front electronics door: Provides access to the processing module electronics and embedded
computer, and the procedure lock.

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Figure 53: Rear view of the Alinity i processing module
Legend:
1. Rear processing center cover: Provides access to the components that perform assay-processing
activities.
NOTE: The rear processing center cover is monitored by one sensor. If the cover is opened when the
instrument status of the processing module is Initializing, Running, or Processing, the status
2. Rear access panel: Provides additional access to processing center components.
3. Rear electronics panel: Provides access to instrument electronics.
4. Processing module main power breaker: Powers on and powers off the power supply.
5. Rear fluidics panel: Provides access to pumps and syringes.
Supply center (Alinity i), page 128

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Processing center (Alinity i)

The processing center is the main activity area of the processing module. Samples and reagents
are dispensed and mixed in reaction vessels (RVs) in the process and pretreatment paths where
assay processing is performed.
Figure 54: Processing center (Alinity i)
Legend:
1. Process path: Provides incubation at a controlled temperature, liquid aspiration, and wash points as
necessary for assay processing
2. Pretreatment path: Provides incubation at a controlled temperature for pretreatment assay protocols
3. Pipetting hardware: Aspirates and dispenses samples and reagents
4. RV loader: Provides the onboard storage for RVs and transports RVs to the process and pretreatment
paths
Process path light cover (Alinity i), page 106

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Process path (Alinity i), page 107

Pretreatment path (Alinity i), page 118
Pipetting hardware (Alinity i), page 122
RV loader (Alinity i), page 127
CMIA technology and reaction sequence (i‑series), page 428
Assay processing (i‑series), page 433
Assay processing for One Step 25 (i‑series), page 434
Assay processing for Two Step 18-4 (i‑series), page 435
Assay processing for pretreatment (i‑series), page 437
STAT assay processing for One Step 11 (i‑series), page 439
STAT assay processing for Two Step 4-4 (i‑series), page 440
Process path light cover (Alinity i)

The process path light cover on the process path prevents external light interference with the
diverter sensors and the optics. One of two configurations will be installed on the system.

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Figure 55: Process path light cover configurations (Alinity i)
Legend:
1. One-piece process path light cover
2. Two-piece process path light cover
Process path (Alinity i)

The process path is a covered, circular path that provides incubation at a controlled
temperature, liquid aspiration, and wash points as necessary for assay processing. The process
path advances reaction vessels (RVs) every 18 seconds and positions them at the designated
locations to process the CMIA reaction.

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Figure 56: Process path (Alinity i)
Legend:
1. Vortexers (VTXR1, VTXR2, and VTXPT): Mix the reaction mixture to suspend microparticles.
2. Diverters (LD, STD, and WZD): Move RVs in the processing module from one lane of the process
path to a different lane during assay processing.
3. Liquid waste arm: Removes the liquid from RVs.
4. Wash zone assemblies (WZ1 and WZ2): Dispense the wash buffer into RVs, and remove and discard
the unbound material from the RV reaction mixture.
5. RV access door (RVA): Provides access to one position on the reaction lane. Use this door only for
diagnostic purposes.
6. Process path motor (PPM): Rotates the process path disk, which holds the RVs, and advances the
RVs from position to position.
7. Pre-Trigger and Trigger manifold (PTT): First dispenses Pre-Trigger Solution into RVs and then
dispenses Trigger Solution into RVs.
8. Optics: Measures the chemiluminescent emission from RVs and outputs the data that corresponds to
the quantity of emission detected.
9. RV unloader (RVU): Removes used RVs from the process path and discards them into the solid waste
container after assay processing is completed.

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Vortexers (Alinity i), page 109
Diverters (Alinity i), page 110
Liquid waste arm (Alinity i), page 111
Wash zone assemblies (Alinity i), page 112
RV access door (Alinity i), page 113
Process path motor (Alinity i), page 114
Pre-Trigger and Trigger manifold (Alinity i), page 115
Optics (Alinity i), page 116
RV unloader (Alinity i), page 117
Vortexers (Alinity i)
Three vortexers are located on the process path:
• R1 pipettor vortexer (VTXR1)
• R2 pipettor vortexer (VTXR2)
• Pre-Trigger vortexer (VTXPT)
The vortexers mix the reaction mixture to suspend microparticles.

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Figure 57: Vortexer (Alinity i)
Diverters (Alinity i)
Diverters move reaction vessels (RVs) in the processing module from one lane of the process
path to a different lane during assay processing. The following three diverters are located on the
process path:
• The load diverter (LD) directs RVs from the load lane to the incubation lane.
• The STAT diverter (STD) directs RVs from the incubation lane to the reaction lane for STAT
assay processing.
• The wash zone diverter (WZD) directs RVs to one of two lanes. One lane moves RVs
through the wash zone where a wash occurs. The other lane moves RVs to the wash zone
bypass lane where a wash does not occur.

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Figure 58: Diverter (Alinity i)
Liquid waste arm (Alinity i)

The liquid waste arm removes the liquid from reaction vessels before the RV unloader discards
them into the solid waste container.

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Figure 59: Liquid waste arm (Alinity i)
Wash zone assemblies (Alinity i)

The wash zone assemblies (WZ1 and WZ2) dispense the wash buffer into reaction vessels
(RVs), and remove and discard the unbound analyte from the reaction mixture in the RVs. Each
wash zone has four positions where the following actions occur:
• At each position, a magnet attracts paramagnetic microparticles to the wall of the RV.
• At position 1, a dispense nozzle dispenses the wash buffer into the RV.
• At position 2 and position 3, a vacuum is applied to the wash zone probes as they move to
the bottom of RVs and aspirate the liquid from RVs. In addition, nozzles dispense the wash
buffer into RVs. Additional wash and aspiration cycles occur at these positions.
• At position 4, a wash zone probe aspirates liquid waste from the RV.

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Figure 60: Wash zone assembly (Alinity i)
RV access door (Alinity i)

The RV access door (RVA) is an opening that provides access to one position on the reaction
lane on the process path. Use this door only for diagnostic purposes and confirm that it is closed
during system operation.

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Figure 61: RV access door (Alinity i)
Process path motor (Alinity i)

The process path motor (PPM) rotates the process path disk, which holds the reaction vessels
(RVs), and advances the RVs from position to position.

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Figure 62: Process path motor (Alinity i)
Pre-Trigger and Trigger manifold (Alinity i)

The Pre-Trigger and Trigger manifold (PTT) first dispenses Pre-Trigger Solution into reaction
vessels (RVs) and then dispenses Trigger Solution into RVs.

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Figure 63: Pre-Trigger and Trigger manifold (Alinity i)
Optics (Alinity i)
The optics measures the chemiluminescent emission from reaction vessels and outputs the data
that corresponds to the quantity of emission detected.

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Figure 64: Optics (Alinity i)
Optical system and measurement sequence (i‑series), page 431
RV unloader (Alinity i)
The RV unloader (RVU) removes used reaction vessels from the process path and discards
them into the solid waste container after assay processing is completed.

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Figure 65: RV unloader (Alinity i)
Pretreatment path (Alinity i)

The pretreatment path is a covered, circular path that provides incubation at a controlled
temperature for pretreatment assay protocols. The pretreatment path advances reaction vessels
(RVs) in two lockstep durations. It advances RVs at 3 seconds, followed by a 15-second lockstep
for a total of two positions every 18 seconds. RVs are positioned at the designated locations to
process a pretreatment assay protocol. After the pretreatment assay protocol is completed, the
sample is transferred to the process path.

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Figure 66: Pretreatment path (Alinity i)
Legend:
1. Pretreatment path motor (pPM): Rotates the pretreatment path disk, which holds the RVs, and
advances the RVs from position to position
2. Pretreatment vortexer (pVTX): Mixes the reaction mixture
3. Pretreatment unload diverter (pUD): Unloads RVs used for sample pretreatments and sample dilutions
from the pretreatment path into the solid waste container
Pretreatment unload diverter (Alinity i), page 119
Pretreatment path motor (Alinity i), page 120
Pretreatment vortexer (Alinity i), page 121
Pretreatment unload diverter (Alinity i)

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The pretreatment unload diverter (pUD) unloads reaction vessels used for sample pretreatments
and sample dilutions from the pretreatment path into the solid waste container.
Figure 67: Pretreatment unload diverter (Alinity i)
Pretreatment path motor (Alinity i)

The pretreatment path motor (pPM) rotates the pretreatment path disk, which holds the reaction
vessels (RVs), and advances the RVs from position to position.

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Figure 68: Pretreatment path motor (Alinity i)
Pretreatment vortexer (Alinity i)

The pretreatment vortexer (pVTX) is located on the pretreatment path. The pretreatment vortexer
mixes the reaction mixture to suspend microparticles.

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Figure 69: Pretreatment vortexer (Alinity i)
Pipetting hardware (Alinity i)

Pipetting hardware aspirates and dispenses samples and reagents. This hardware includes
sample and reagent pipettors and sample and reagent wash cups. The induction heater wash
cup is an optional hardware component that can replace the sample wash cup. One of two
configurations will be installed on the system.

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Figure 70: Pipetting hardware components (Alinity i)
Legend:
1. Sample pipettor (S): Aspirates and dispenses samples into reaction vessels (RVs)
2. Reagent pipettors (R1 and R2): Aspirate and dispense reagents into RVs
3. Wash cups (SW, R1W, and R2W): Wash any fluid that remains from the interior and exterior surfaces
of probes

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Figure 71: Pipetting hardware components with the induction heater wash cup (Alinity i)
Legend:
1. Sample pipettor (S): Aspirates and dispenses samples into reaction vessels (RVs)
2. Reagent pipettors (R1 and R2): Aspirate and dispense reagents into RVs
3. Wash cups (R1W and R2W): Wash any fluid that remains from the interior and exterior surfaces of
probes
4. Induction heater wash cup (IHW): Washes any fluid that remains from the sample probe interior,
exterior, and tip with wash buffer that is warmed by the heated probe
Pipettors (Alinity i), page 124
Wash cups (Alinity i), page 125
Induction heater wash cup (Alinity i), page 126
Pipettors (Alinity i)

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Pipettors detect, aspirate, transfer, and dispense samples and reagents into reaction vessels
(RVs). These pipettor assemblies include a pressure-monitoring system that helps to identify
aspiration errors. Three pipettors that have the following functions are located on the system:
• The sample pipettor (S) detects, aspirates, transfers, and dispenses samples into RVs in the
process path and the pretreatment path. It also transfers pretreated samples from the
pretreatment path to the process path after the appropriate incubation period.
• The reagent 1 pipettor (R1) detects, aspirates, transfers, and dispenses reagents into RVs in
the process path and the pretreatment path. It also transfers diluted samples from the
pretreatment path to the process path as required.
• The reagent 2 pipettor (R2) detects, aspirates, transfers, and dispenses reagents into RVs in
the process path.
Figure 72: Pipettor (Alinity i)
Wash cups (Alinity i)

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Active wash cups (SW, R1W, and R2W) wash any fluid that remains from the interior and
exterior surfaces of probes. In addition, a vacuum source dries the exterior surfaces of probes.
Figure 73: Wash cup (Alinity i)
Induction heater wash cup (Alinity i)

The induction heater wash cup is an optional hardware component that is available for the
Alinity i processing module. This component is an active wash cup where the sample probe
dispenses excess sample and any remaining fluid is washed from the probe interior, exterior,
and tip with heated wash buffer. The sample probe is heated and the wash buffer is warmed as
it flows through the probe to provide improved washing.
Installation of the induction heating hardware is required for some assays. For more information,
see the assay documentation.

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Figure 74: Induction heater wash cup (Alinity i)
RV loader (Alinity i)
The RV loader system (RVL) provides the onboard storage for reaction vessels (RVs) and
transports RVs to the process path and the pretreatment path.
The RV loader performs the following functions:
• Feeds RVs from the upper hopper to the lower hopper as needed
• Lifts RVs one at a time and places them in an upright position in the linear queue
• Lifts RVs from the linear queue and places them on the process path and the pretreatment
path

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Figure 75: RV loader assembly (Alinity i)
Legend:
1. Upper hopper: Stores bulk RVs loaded by the operator.
2. Lower hopper and RV orienter: The lower hopper stores a limited amount of RVs. The RV orienter lifts
one RV at a time and places the RV in the linear queue.
3. Linear queue: Stages upright RVs in preparation for loading.
4. RV pick and place assembly: Moves RVs one at a time to the process path and the pretreatment
path.
Supply center (Alinity i)

The supply center is the onboard storage area for bulk solutions and reaction vessel (RV) solid
waste.

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Figure 76: Supply center (Alinity i)
Legend:
1. Bulk solution storage area: Provides the onboard storage for replacement bulk solution bottles
2. Bulk solution reservoir area: Provides the onboard storage for in-use bulk solutions
3. RV waste storage area: Provides the storage for used RVs
Bulk solution storage area (Alinity i), page 129
Reservoir areas (Alinity i), page 130
RV waste storage area (Alinity i), page 132
Bulk solution storage area (Alinity i)

The bulk solution storage area, which is located on the bulk solution door, provides the onboard
storage for replacement bulk solution bottles. Bulk solutions from the replacement bottles fill
onboard bulk solution reservoirs. Each bottle has a unique keyed cap that locks into its
appropriate key slot in a bottle holder.

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Figure 77: Bulk solution storage area (Alinity i)
Legend:
1. Concentrated Wash Buffer: Mixed with purified water and then pumped to sample and reagent
pipettor assemblies and to wash zones during assay processing.
2. Trigger Solution: Produces the chemiluminescent reaction that provides the final read.
3. Pre-Trigger Solution: Separates the acridinium dye from the conjugate that is bound to the
microparticle complex. This action prepares the acridinium dye for the addition of Trigger Solution.
4. Bottle release button: Releases a bulk solution cap from a bottle holder to remove and replace a bulk
solution bottle.
5. Bottle holder: Stores a replacement bulk solution bottle. Contains a mechanism that pierces the bulk
solution septum.
Bulk solutions (i‑series), page 151
Reservoir areas (Alinity i)

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The bulk solution reservoir area, which is located in the supply center, provides the onboard
storage for bulk solutions in use during assay processing. When onboard bulk solution reservoirs
are empty, bulk solutions from replacement bottles on the bulk solution door fill the reservoirs
without an interruption in system operation. Concentrated Wash Buffer from its onboard bulk
solution reservoir is diluted tenfold by the system and is stored in a 4 L diluted wash buffer
reservoir for use during assay processing.
Figure 78: Bulk solution reservoir area (Alinity i)
Legend:
1. Reservoir bottle tray: Holds transfer pumps, bulk solution reservoirs, and the vacuum and waste
accumulator. Slides out to access the bulk solution reservoirs.
2. Transfer pump rack: Holds transfer pumps for the Pre-Trigger Solution, the Trigger Solution, and the
Concentrated Wash Buffer. The pumps transfer bulk solutions from replacement bottles to bulk
solution reservoirs.
3. Concentrated Wash Buffer reservoir: Holds in-use Concentrated Wash Buffer.
4. Trigger Solution reservoir: Holds in-use Trigger Solution.
5. Pre-Trigger Solution reservoir: Holds in-use Pre-Trigger Solution.

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Figure 79: Pump drawer (Alinity i)
Legend:
1. Diluted wash buffer reservoir: Holds diluted wash buffer for use during assay processing
RV waste storage area (Alinity i)

The RV waste storage area, which is located in the supply center, provides storage for the RV
waste container and holds used reaction vessels (RVs).

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Figure 80: RV waste storage area (Alinity i)
Legend:
1. RV waste chute: Directs the used RVs into the RV waste container. The RV waste container can be
removed during assay processing. When the container is removed, the RV waste chute closes and
holds 50 RVs before the processing module pauses.
2. RV waste container: Holds the used RVs.
3. RV waste storage tray: Holds the RV waste container.
Reagent supply center (Alinity i)

The reagent supply center provides cooled storage at a controlled temperature for reagent
cartridges, maintenance solutions, and frequently used calibrators and controls. Cartridges and
vial racks are loaded on the reagent and sample manager (RSM) and are transferred to the
reagent positioner by the RSM transport.

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Figure 81: Reagent supply center (Alinity i)
Legend:
1. Reagent carousel: Holds reagent cartridges, maintenance solutions, and frequently used calibrators
and controls. The carousel rotates to provide reagent access to reagent 1 and reagent 2 pipettors.
2. Reagent positioner: Positions cartridges and onboard vial racks to load in the reagent carousel or
onto the loading area. When the reagent positioner is in the open position, the cartridge or rack can
be transferred to the loading area. When the reagent positioner is in the closed position, the cartridge
or rack can be transferred to the reagent carousel.
3. Reagent transport: Places cartridges and onboard vial racks in the reagent carousel or onto the
reagent positioner.
Reagent carousel (Alinity i), page 134
Reagent carousel (Alinity i)

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The reagent carousel is a rotating, circular device that performs the following functions:
• Holds a maximum of 47 bar-coded reagent cartridges, maintenance solutions, and vial racks
in a cooled environment at a controlled temperature
• Provides microparticle dispersion by continuous rotation of microparticle reagent bottles
• Rotates to position reagent cartridges and onboard solutions so that reagents or solutions
can be aspirated and dispensed
• Rotates to position vial racks for transfer to the sample positioner so that calibrators and
controls can be aspirated and dispensed
Figure 82: Reagent carousel (Alinity i)
Legend:
1. Reagent segment: A section of the reagent carousel that holds a maximum of six cartridges or vial
racks. The reagent carousel has a total of eight reagent segments. One segment contains the
reagent carousel calibration target. This segment holds a maximum of five cartridges or vial racks.
2. Reagent position: A section of a reagent segment that holds one cartridge or vial rack.

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3. Reagent carousel calibration target: A calibration target that is used to align the reagent pipettor to
cartridges and vials.
Optional components
The following components are optional for processing modules:
Uninterrupted power Provides a temporary, continuous flow of power to the

supply (UPS) processing module during a power failure.
External waste pump Moves waste from the waste outlet to an elevated drain.
High-concentration Collects the high-concentration liquid waste from the cuvettes

waste bottle (c‑series) and the ICT unit.
External waste pump, page 136
Empty the high-concentration waste bottle and update the inventory (c‑series), page 583
External waste pump

The external waste pump is an optional component that moves waste from the waste manifold to
an elevated drain when a floor drain is not available.

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Figure 83: Front view of the external waste pump
Legend:
1. Power outlet: Provides power to the external waste pump.
2. Power switch: Turns on and turns off the power to the pump. When the power switch is turned on, the
pump automatically activates to move the waste.
3. Voltage select switch: Shifts the allowable voltage from 115 V to 230 V.
4. Manual operating switch: Turns on the power to the pump and activates the pump.

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Figure 84: Rear view of the external waste pump
Legend:
1. Waste outlet quick disconnect: Provides a connection for tubing to an elevated drain
2. Inlet quick disconnect: Provides a connection for tubing from the waste manifold
External waste pump electrical specifications and requirements, page 464

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Section 1 Alinity system software overview
Alinity system software overview

The Alinity system software has a user interface that is designed to provide access to system
information, software functions, and Help for an active screen. The user interface is a display
format where the operator can select icons, buttons, menu commands, and other screen
elements.
The user interface is common among all Alinity systems.
Figure 85: User interface layout
Legend:
1. Menu bar: Provides navigation elements and status indicators. Each icon on this bar represents a
screen category. When an icon is selected, an associated screen is displayed. The Alert Center at
the top of this bar indicates when alerts and notifications occur on the system and provides access to
details about alerts and notifications.
2. Screen header: Provides the screen title, the system name, the Help button, the Notepad button, the
name of the logged-on operator, the Lock button, the date and time, and the software version.
3. Information area: Provides access to all system information and functions associated with the
selected screen element.
4. Function buttons: Provide access to functions associated with the active screen. Buttons with blue
text are available for use. Buttons with purple text are unavailable for use until a screen element is
selected.
5. Flyout: Provides additional details or additional functions associated with the active screen.

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Alinity system software overview Section 1
6. Critical message: Provides information about conditions or errors of system operation.

7. Help button: Provides access to the Help for the active screen, a flyout, or a message code.
Descriptions of screen elements, page 140
Menu bar, page 144
Descriptions of screen elements

Screen elements are items on each screen that are used to interact with the system software.
The following list provides descriptions of screen elements:
Icons Display a screen.
Menus Display a screen.
Tabs Used to group the same type of information or to filter

information.
Buttons Initiate a command such as the following examples:

• Display another screen or flyout.
• Add items to a list.
• Refresh the information on the screen.
• Confirm that entered edits are saved.
• Delete items from the system.
• Display the Help for the active screen, flyout, or message
code.
Flyouts Display additional information or menus, or are used for

specific tasks such as search, print, and update.
Badges Used on menu buttons and icons to display status notifications

such as alerts and warnings, and informational notifications
such as a number on the Notepad button indicating unread
notes.
Data entry boxes • Text boxes: Used to type text. An asterisk is displayed
when the information is required.
• Spin boxes: Used to type text or to enter text by tapping
the Up Arrow and Down Arrow buttons. An asterisk is
displayed when the information is required.

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Drop-down lists Display a list from which to select one item.
Options Display a list of choices from which to select one item.
Check boxes Display a list of choices from which to select one or more
items.
Sliders Used to select a value from a range of values.
Screen tips Display an information button when a cursor is positioned over

a data entry box on the user interface to display information
about the type of data to be entered in the box.
Specific screen element descriptions that explain the kind of information to enter, select, or view
are available for each screen and can be accessed by the links provided in the following
Related information... section.
Home screen element descriptions, page 520
Supplies screen element descriptions (c‑series), page 562
Supplies screen element descriptions (i‑series), page 571
Orders screen element descriptions, page 660
Sample Status screen element descriptions, page 693
Results screen, Unreleased tab element descriptions, page 707
Results screen, Specimen tab element descriptions, page 708
Results screen, Control tab element descriptions, page 710
Results screen, Exception tab element descriptions, page 711
Calibration Status screen element descriptions, page 796
Procedures Log screen, Maintenance tab element descriptions, page 852
System Logs screen, All Messages tab element descriptions, page 1044
System Logs screen, Notifications/Alerts tab element descriptions, page 1036
System Logs screen, Informational tab element descriptions, page 1038
System Logs screen, Inventory tab element descriptions, page 1039
System Logs screen, User Access tab element descriptions, page 1040
System Logs screen, Configuration tab element descriptions, page 1041
System Logs screen, Interfaces tab element descriptions, page 1042
System Logs screen, Abbott Mail tab element descriptions, page 1043
Cal/QC Inventory screen element descriptions, page 588
Reagents screen, Current tab element descriptions, page 609
Reagents screen, Historical tab element descriptions, page 612

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Create Order screen, Specimen tab, Single Specimen element descriptions, page 669
Create Order screen, Control tab element descriptions, page 676
Create Order screen, Calibration tab element descriptions, page 679
Procedures screen element descriptions, page 839
Procedures Log screen, Diagnostics tab element descriptions, page 853
Users Import screen, Users Export screen element descriptions, page 171
Calibrator Set screen element descriptions, page 307
Calibrator Set View/Edit screen element descriptions, page 308
Import Calibrators screen element descriptions (c‑series), page 309
Install/Uninstall Assays screen, Available Files tab element descriptions, page 321
Install/Uninstall Assays screen, Installed Files tab element descriptions, page 323
Import/Export Assays screen, Export Files tab element descriptions (c‑series), page 329
Import/Export Assays screen, Import Files tab element descriptions (c‑series), page 329
Quality Control screen element descriptions, page 343
Control Create/Edit screen element descriptions, page 343
Import screen element descriptions, page 348
Westgard screen element descriptions, page 365
Install/Uninstall Procedures screen, Available Files tab element descriptions, page 368
Install/Uninstall Procedures screen, Installed Files tab element descriptions, page 369
User-Defined Maintenance screen, Create/Edit tab element descriptions, page 372
User-Defined Maintenance screen, Export tab element descriptions, page 374
Backup/Restore screen element descriptions, page 380
System Updates screen element descriptions, page 384
System Update Import screen element descriptions, page 388
Control Summary Details screen element descriptions, page 743
Assay Parameters screen element descriptions, page 252
Assay Display Order screen element descriptions, page 334
Panel Definition screen element descriptions, page 336
Current Firmware screen element descriptions, page 398
Users screen element descriptions, page 170
Create New User screen element descriptions, page 173
Edit User screen element descriptions, page 175
User Profile screen element descriptions, page 180
Modules screen, reagent and sample manager (RSM) element descriptions, page 183
Modules screen, c‑series element descriptions, page 184
Modules screen, i‑series element descriptions, page 187
Printers screen element descriptions, page 191
Bar Codes screen element descriptions, page 199
Reagents and Supplies screen, Reagents/Diluents tab element descriptions, page 202

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Reagents and Supplies screen, Supplies tab element descriptions, page 205
Reports screen element descriptions, page 211
Abbott Mail screen element descriptions, page 214
Audio Settings screen element descriptions, page 223
Host Setup screen element descriptions, page 225
HL7 Communication screen element descriptions, page 230
ASTM Communication screen element descriptions, page 232
Shortcuts screen element descriptions, page 236
Automatic Backup screen element descriptions, page 238
AbbottLink screen element descriptions, page 244
Cal/QC Ordering screen element descriptions, page 340
Troubleshooting screen element descriptions, page 395
Calibration Status Details screen element descriptions, page 800
Perform Procedure screen element descriptions, page 843
Log On screen element descriptions, page 507
Abbott Mail Inbox screen, All tab element descriptions, page 539
Abbott Mail Inbox screen, Assay Files tab element descriptions, page 540
Abbott Mail Inbox screen, Assay Inserts tab element descriptions, page 541
Abbott Mail Inbox screen, System Updates tab element descriptions, page 542
Abbott Mail Inbox screen, Calibrator Data tab element descriptions (c‑series), page 543
Manual File Request screen, Assay Files tab element descriptions, page 547
Manual File Request screen, Calibrator Data tab element descriptions (c‑series), page 548
Reagent Cartridge Details screen element descriptions, page 615
Order Details (Single Specimen, Control, and Calibrator) screen element descriptions, page 664
Sample Details (Specimen, Control, and Calibrator) screen element descriptions, page 698
Result Details (Specimen and Control) screen element descriptions, page 715
Quality Control Summary screen element descriptions, page 740
General Settings screen element descriptions, page 219
Levey-Jennings (Graph) screen element descriptions, page 733
Point Details screen element descriptions, page 736
Alinity PRO screen element descriptions, page 242
Distance Alert screen element descriptions, page 246
Assay Parameters screen, General tab element descriptions (c‑series photometric), page 253
Assay Parameters screen, General tab element descriptions (c‑series potentiometric), page 260
Assay Parameters screen, General tab element descriptions (i‑series), page 262
Assay Parameters screen, Calibration tab element descriptions (c‑series photometric), page 266
Assay Parameters screen, Calibration tab element descriptions (c‑series potentiometric), page
272
Assay Parameters screen, Calibration tab element descriptions (i‑series), page 274

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Order Details (Bar-Coded Batch Specimen) screen element descriptions, page 666
Create Order screen, Specimen tab, Bar-Coded Batch element descriptions, page 671
Assay Parameters screen, General tab element descriptions (calculated), page 265
Assay Parameters screen, Retest Rules tab element descriptions, page 282
Assay Parameters screen, SmartWash tab element descriptions (c‑series), page 1569
LAS Communication screen element descriptions, page 234
Assay Parameters screen, Results tab element descriptions, page 276
Current Software screen element descriptions, page 397
Assay Parameters screen element descriptions (c‑series photometric, user defined), page 1541
Assay Parameters screen, General tab element descriptions (c‑series photometric, user defined),
page 1543
Assay Parameters screen, Calibration tab element descriptions (c‑series photometric, user
defined), page 1556
Assay Parameters screen, Results tab element descriptions (c‑series photometric, user defined),
page 1564
Menu bar
The menu bar provides navigation elements that are used to display screens, flyouts, and
menus. The following figure shows examples of the Alert Center flyout, status indicators, buttons,
icons, and the System menu.
Figure 86: Menu bar

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Legend:
1. Alert Center: Provides the Alert Center button, which displays a flyout of status information, and
provides two types of status indicators for system problems that require attention. Status indicators
called badges are displayed on icons to notify the operator when a specific system problem requires
attention:
– A red triangle (alert) badge indicates system problems that require immediate attention.
– An amber circle (notification) badge indicates system problems that require attention that is not
immediate.
2. Icons: Navigation elements that provide access to specific screens and functions. The menu bar
provides these icons:
– Home
– Sample Status
– Orders
– Results
– QC
– CAL
– Reagents
– Supplies
System button: Displays a menu of commands. System menu commands that are configured as
icons are not displayed on the menu.
3. Configurable icons: Navigation elements that can be configured to provide navigation for common
functions. Some of the System menu commands can be configured for these icons.

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Required consumables Section 1
Required consumables
Required consumables are replenishable items that are needed for sample processing on the
Alinity ci‑series. Be sure to maintain an adequate inventory of required consumables.
CAUTION: Many of the consumables used with the Alinity ci‑series are mixtures of
chemical substances or biological substances. Some of the mixtures may be hazardous
to the operator under certain conditions. See warnings or instructions provided on
product-specific labels, in the product documentation, and in product-specific Safety
Data Sheets.
Reagent kits and components, page 146
Controls, page 148
Calibrators, page 149
Onboard solutions (c‑series), page 152
Maintenance solutions (c‑series), page 153
ICT module (c‑series), page 154
Probe conditioning solution (i‑series), page 154
Reaction vessels (i‑series), page 155
Sample cups, page 156
Biological hazards, page 821
Chemical hazards, page 823
Reagent kits and components

Reagent kits are one or more cartridges that contain all the necessary reagent components for
an Alinity ci‑series assay.
Reagent cartridges can be stored on the system according to the assay-specific instructions. For
more information about onboard storage, see the assay documentation.
Abbott prepackaged reagent cartridges contain a two-dimensional bar code. Each bar code
includes the following information:
• Reagent identifier
• Reagent serial number
• Test size (number of tests for each cartridge)
• Expiration date

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Section 1 Required consumables
• Onboard stability time

• Master calibration information for assays that use the 2-point adjustment calibration method
(only for Alinity i‑series)
Figure 87: Reagent cartridges and components
Legend:
1. Alinity i reagent cartridge: Provides the necessary components for an Alinity ci‑series
chemiluminescent microparticle immunoassay assay. Each reagent bottle in the cartridge contains an
integrated septum unless otherwise indicated in the assay documentation.
2. Alinity c reagent cartridge: Provides the necessary components for an Alinity ci‑series photometric or
potentiometric assay.
3. Alinity Reagent Replacement Cap: Seals a reagent cartridge to prevent reagent leakage when the
cartridge is removed from the system and is stored in an external refrigerator.

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Controls
Controls are samples that contain known concentrations of analyte. Controls are available as
single-constituent and multiconstituent controls. Some controls can be stored for use in the
reagent carousel. To identify the controls that are required for an assay, see the assay
documentation.
Figure 88: Alinity ci‑series controls
Legend:
1. Single-constituent control: An assay-specific sample that contains known concentrations of an
analyte.
2. Multiconstituent control: A sample that contains multiple analytes.
3. Alinity ci‑series Calibrator/Control Replacement Caps: Replace the original caps on calibrator and
control vials that are loaded on the reagent and sample manager for calibration and control testing.
The replacement cap seals the vial to prevent leakage when the vial is removed from the system and
is stored in an external refrigerator. The original cap is not used to prevent analyte cross
contamination.

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Calibrators
Calibrators are samples that contain known concentrations of analyte. A variety of single-
constituent and multiconstituent calibrators are used on the Alinity c‑series. Single-constituent
calibrators are used on the Alinity i‑series. Some calibrators can be stored in the reagent
carousel. To identify the required calibrators for an assay, see the assay documentation.
Figure 89: Alinity ci‑series calibrators
Legend:
1. Alinity i calibrators: Include single-constituent calibrators that are used in the calibration of i‑series
assays.
2. Alinity c calibrators: Include single-constituent and multiconstituent calibrators that are used in the
calibration of c‑series photometric assays.
3. Alinity c ICT calibrators: Used in the calibration of c‑series potentiometric assays.

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4. Alinity ci‑series Calibrator/Control Replacement Caps: Replace the original caps on calibrator and
control vials that are loaded on the reagent and sample manager for calibration and control testing.
The replacement cap seals the vial to prevent leakage when the vial is removed from the system and
is stored in an external refrigerator. The original cap is not used to prevent analyte cross
contamination.
Bulk solutions (c‑series)

Bulk solutions are liquid solutions that are provided in large quantities for use during sample
processing. The Alinity c‑series uses three bulk solutions. Each bulk solution bottle is loaded on
the bulk solution door.
Figure 90: Bulk solutions (c‑series)
Legend:
1. Alkaline Wash (0.5 L bottle): An alkaline wash solution that is used by the cuvette washer to clean the
cuvettes after sample analysis. Alkaline Wash is stored at a temperature of 15°C to 30°C and is
stable on the system for 30 days.
2. ICT Reference Solution (975 mL in a 1 L bottle): A midconcentration standard solution that is
aspirated and analyzed by the ICT module before and after each sample. The solution provides a
reference potential that is used in result calculation. ICT Reference Solution is stored at a
temperature of 15°C to 30°C and is stable on the system for 90 days.
3. Acid Wash (0.5 L bottle): An acidic wash solution that is used by the cuvette washer to clean the
cuvettes after sample analysis. Acid Wash is stored at a temperature of 15°C to 30°C and is stable on
the system for 30 days.
Bulk solution storage area (Alinity c), page 97
Bulk solution reservoir area (Alinity c), page 98
Solutions used in daily operations (c‑series), page 577

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Bulk solutions (i‑series)

Bulk solutions are liquid solutions that are provided in large quantities for use during assay
processing. The Alinity i‑series uses three bulk solutions. Each bulk solution bottle is loaded on
Figure 91: Bulk solutions (i‑series)
Legend:
1. Pre-Trigger Solution, LN 06P1265 (1 L bottle): A solution that contains 1.32% (W/V) hydrogen
peroxide solution that separates the acridinium dye from the conjugate that is bound to the
microparticle complex. This action prepares the acridinium dye for the addition of Trigger Solution.
Pre-Trigger Solution is sensitive to light, is stored at a temperature of 2°C to 8°C, and is stable on the
system for 16 days.
2. Trigger Solution, LN 06P1160 (1 L bottle): A solution that contains 0.35N sodium hydroxide solution
that produces the chemiluminescent reaction that provides the final read. This solution is stored at a
temperature of 2°C to 30°C and is stable on the system for a maximum of 28 days. Some assays
require a shorter onboard stability period. For more information, see the assay documentation.
3. Concentrated Wash Buffer, LN 06P1368 (2 L bottle): A solution that contains phosphate-buffered
saline and antimicrobial agents. This solution is diluted tenfold by the system and then is pumped to
sample and reagent pipettor assemblies and to wash zones during assay processing. This solution is
stored at a temperature of 15°C to 30°C and is stable on the system for 30 days.
Bulk solution storage area (Alinity i), page 129
Reservoir areas (Alinity i), page 130

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Onboard solutions (c‑series)

Onboard solutions are detergents that are used to wash sample probes, reagent probes, mixers,
and reaction cuvettes. The solutions are used by the SmartWash feature during system
operation. They may also be used during some maintenance and diagnostic procedures.
Onboard solutions include Acid Probe Wash, Detergent A, and Detergent B. For specific
information about each solution, see the product documentation.
Figure 92: Onboard solutions (c‑series)
SmartWash feature (c‑series), page 423

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Maintenance solutions (c‑series)

The c‑series maintenance solutions are liquid solutions that are supplied as a three-component
kit and are used during the automated daily maintenance procedure. The large bottle of the
maintenance cartridge is filled with Water Bath Additive, an antimicrobial solution that is used to
prevent and control microbial contamination in the water bath. During maintenance, the solution
is dispensed into the water bath. The small bottle of the maintenance cartridge is empty and is
reserved for the reconstituted Cleaning Solution. Cleaning Solution is supplied as a lyophilized
material with a diluent. The reconstituted cleaning solution is added to the small bottle. During
daily maintenance, the reconstituted cleaning solution is used to clean sample and reagent
probes, mixers, the ICT probe, and the ICT module. The maintenance solutions are stored at a
temperature of 15°C to 30°C and are stable on the system for 14 days or 12 tests, whichever
occurs first.
Figure 93: Maintenance solutions (c‑series)
5501 Daily Maintenance (c‑series), page 858

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ICT module (c‑series)

The ICT module is an integrated chip that is a component of the ICT unit and contains the
sodium (Na+), potassium (K+), chloride (Cl-), and reference electrodes. The warranty for the ICT
module is 20,000 samples or 3 months after installation, whichever occurs first.
Figure 94: ICT module (c‑series)
Probe conditioning solution (i‑series)

Probe conditioning solution is a solution that contains recalcified human plasma. Some
maintenance procedures require this solution after the sample pipettor probe is cleaned to
condition the probe to prevent the nonspecific binding of analytes in the probe. This solution is
stored at a temperature of 2°C to 8°C.

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Figure 95: Probe conditioning solution (i‑series)
Reaction vessels (i‑series)

Reaction vessels (RVs) are disposable containers in which the CMIA reaction occurs. The
operator can add RVs at any time.
Figure 96: Reaction vessel (i‑series)

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Sample cups
Sample cups are 1400 μL disposable containers that hold samples. Volume graduation marks at
125 μL, 500 μL, and 1400 μL eliminate the need to pipette with precision.
To facilitate the positive identification of samples, sample cups can be placed in sample tubes
that have bar code labels.
Figure 97: Sample cup

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Section 1 Required accessories
Required accessories
Required accessories are parts that are needed for sample processing on the Alinity ci‑series.
Be sure to maintain an adequate inventory of required accessories.
Racks, page 157
Trays, page 158
Reagent cartridge with empty bottles (c‑series), page 158
Racks
Racks are accessories that are used on the reagent and sample manager to transport
specimens, calibrators, and controls to the sample pipettor. The Alinity ci‑series uses three types
of racks.
Figure 98: Racks
Legend:
1. Vial rack: Bar-coded for identification with the letter V. Holds six open vials of calibrators or controls
for immediate use. The rack cannot be stored in the reagent carousel.
2. Onboard vial rack: Bar-coded for identification with the letter U. Holds six vials of calibrators or
controls. The rack is stored in the reagent carousel.
3. Sample rack: Bar-coded for identification. Holds six primary tubes, aliquot tubes, or sample cups. Any
combination of tubes and cups can be used in the rack.

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Required accessories Section 1
4. Sample gauge: Used to verify that the amount of sample in an aliquot tube exceeds 8 mm.
Reagent and sample manager (RSM) sample processing for onboard calibrators and controls,
page 641
Onboard storage criteria for calibrator and control vials, page 642
Trays
Trays are accessories that are used to hold multiple racks of samples, calibrators, and controls
and to hold reagent cartridges. Trays of racks and cartridges are loaded on the reagent and
sample manager. Each tray holds a maximum of five racks or cartridges. Empty trays may
remain on the loading area to create five positions to load racks or cartridges one at a time.
Figure 99: Tray
Reagent cartridge with empty bottles (c‑series)

The c‑series reagent cartridges with empty bottles are single-use cartridges that contain two
empty reagent bottles that can be filled with saline, user-defined sample diluents, and user-
defined reagents. When the bottles are filled and labeled with a one-dimensional (1D) reagent
bar code, the cartridges can be loaded in the reagent carousel. The R1 bottle is the larger bottle
and the R2 bottle is the smaller bottle.
Two types of empty cartridges are available: Reagent Cartridge, Clear (Large), LN 04S1740 and
Reagent Cartridge, Black (Large), LN 04S1720 or LN 04S1750.
The c‑series Reagent Cartridge, Clear (Large), contains two empty, clear reagent bottles that
can be filled with saline or non-light-sensitive user-defined sample diluents and user-defined

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Section 1 Required accessories
reagents. The maximum fill volume of the R1 bottle is 74 mL or to the maximum fill line (MAX).
The maximum fill volume of the R2 bottle is 46 mL or to the maximum fill line (MAX).
The c‑series Reagent Cartridge, Black (Large), contains two empty, black reagent bottles that
can be filled with saline or user-defined sample diluents and user-defined reagents. This
cartridge must be used for light-sensitive user-defined sample diluents and user-defined
reagents. The maximum fill volumes depend on the list number of the product used:
• LN 04S1720:
– R1 bottle, saline: 74 mL
– R1 bottle, user-defined diluent: 50 mL
– R1 bottle, user-defined reagent: 50 mL
• LN 04S1750:
– R1 bottle: 74 mL
– R2 bottle: 46 mL
NOTE: Since the black cartridges are visually identical, if the cartridge list number cannot be
determined, use the fill volumes for LN 04S1720.
IMPORTANT: Do not exceed the maximum fill volumes for the reagent bottles to prevent
damage to the reagent carousel.
Figure 100: c‑series Reagent Cartridges, Black (Large) and Clear (Large)
Legend:
1. c‑series Reagent Cartridge, Black (Large)
2. c‑series Reagent Cartridge, Clear (Large)

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Required accessories Section 1
Prepare sample diluents and user-defined reagents (c‑series), page 627

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Section 1 Automatic processing module activities
Automatic processing module activities

Periodically, system operations occur automatically to maintain the optimal performance and
condition of the system.
System flush (c‑series), page 161
System flush (i‑series), page 161
System prime (i‑series), page 162
Processing module wash (c‑series), page 162
Automatic rotation of the reagent carousel (c‑series), page 163
System flush (c‑series)

A system flush is an automated process that removes bubbles that may be present. The system
performs periodic flushes at the beginning of a run on all pipettors by pumping purified water
through the pipettor probes into the wash cups.
ICT Reference Solution, Alkaline Wash, and Acid Wash are flushed automatically when the
following situations occur:
• The first time that the instrument status of the processing module transitions to Running
after the module is powered on
• After a bulk solution is replaced on the bulk solution door and the bulk solution reservoir is
at or below the lowest detectable level
System flush (i‑series)

A system flush is an automated process that removes bubbles that may be present. The system
performs periodic flushes on all pipettors by pumping wash buffer through the pipettor probes
into the wash cups. To flush the wash zone assemblies and the Pre-Trigger and Trigger
manifold, the system pumps fluid through a bypass valve and into the waste line.
Wash buffer, Pre-Trigger Solution, and Trigger Solution are flushed automatically when one of
the following situations occurs:
• After 8 hours of inactivity when the instrument status of the processing module is Running
• The first time that the instrument status of the processing module transitions to Running
after the module is powered on

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Automatic processing module activities Section 1
• After a bulk solution is replaced on the bulk solution door and the bulk solution reservoir is
at or below the lowest detectable level
System prime (i‑series)

A system prime is an automated process that removes air from wash zone delivery nozzles, Pre-
Trigger delivery nozzles, and Trigger delivery nozzles. To perform a prime, the system pushes
fluid through the delivery nozzles and into a reaction vessel (RV). Then, the RV is discarded
automatically.
The wash zone delivery nozzles, the Pre-Trigger delivery nozzles, and Trigger delivery nozzles
are primed when the instrument status of the system transitions from Running to Processing.
Processing module wash (c‑series)

Processing module wash is the process that cleans hardware components that have come in
contact with reagents and samples.
The following table describes the wash solutions used for each hardware component.
Component Wash
Sample probes and • A wash with purified water is performed during assay processing.
reagent probes • Additional washes with purified water, Acid Probe Wash, Detergent A, or
Detergent B (only for reagent probes) may be performed if a SmartWash is
configured in the assay parameters.
• Automatic washes with Detergent A and Acid Probe Wash are performed
during assay processing every 1500 tests.
Cuvette segments • Washes with purified water, Alkaline Wash, and Acid Wash are performed
before and after each use.
• Additional washes with Acid Probe Wash, Detergent A, or Detergent B may be
performed if a SmartWash is configured in the assay parameters.
Mixers • A wash with purified water is performed during assay processing.
• Additional washes with purified water, Acid Probe Wash, Detergent A, or
Detergent B may be performed if a SmartWash is configured in the assay
parameters for the corresponding reagent probe.
• Automatic washes with Detergent A and Acid Probe Wash are performed
during assay processing every 1500 tests.

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Section 1 Automatic processing module activities
Automatic rotation of the reagent carousel (c‑series)

Automatic rotation of the reagent carousel is a programmed rotation that stabilizes the carousel
temperature. The reagent carousel automatically rotates 18 positions every 20 minutes when the
instrument status of the processing module is Running or Idle.

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Automatic processing module activities Section 1
NOTES

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Section 2 Installation procedures and special requirements
Introduction
For accurate test results and optimal system performance, the Alinity ci‑series must be correctly
installed. After the system has been installed, configure it to meet individual laboratory
requirements.
System installation and relocation, page 166
System configuration, page 168
Utilities screen, page 379
Assay applications (c‑series photometric), page 1539

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Installation procedures and special requirements
System installation and relocation Section 2
System installation and relocation

An Abbott Laboratories representative performs the installation and the relocation of the
Alinity ci‑series.
Installation procedures and special requirements, page 165
System installation, page 166
System checkout, page 166
System relocation, page 167
System installation
Before the installation of the Alinity ci‑series, an Abbott Laboratories representative confirms that
the site is prepared. The system location must meet environmental specifications and electrical
requirements before the representative can install the system.
The representative unpacks, positions, and installs the system. During the installation, the
representative performs the system setup and confirms that the system operates within the
manufacturer's specifications.
After the installation, the customization or configuration of the system may be performed before
any testing is initiated.
Specifications and requirements, page 446
System checkout
After the Alinity ci‑series is installed, the following procedures may be performed to ensure that
the system operates appropriately:
• Install assay files.
• Configure system settings.
• Configure Abbott assays.
• Configure user-defined assays.
• Configure calibrator sets.
• Configure quality controls.
• Order and calibrate assays.
• Order and run controls.

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Section 2 System installation and relocation
• Perform testing that is specific to the site requirements.
Install assay files, page 325
Configure screen, General tab, page 168
Configure screen, Computer tab, page 216
Configure screen, Assay tab, page 250
Orders screen, page 659
System relocation
For information about the relocation of the Alinity ci‑series, contact an Abbott Laboratories
representative.
CAUTION: Biological RISKS. This activity or area may expose you to potentially
infectious material.
Before the system can be moved or can be shipped, decontamination is required.
Requirements for decontamination, page 829

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System configuration Section 2
System configuration
Configuration settings define the information that the Alinity ci‑series needs to meet laboratory-
specific requirements. System configuration is performed after system installation. The system
can be reconfigured at any time if necessary.
Configure screen, Maintenance & Diagnostics tab, page 367
Configure screen, General tab

The operator can perform the following tasks from the General tab of the Configure screen:
Users • Create new users.
• Edit existing users.
• Manage user PINs.
• Export and import users from one Alinity ci‑series to a
different Alinity ci‑series.
User Profile • Configure a personal display theme.

• Change a personal user PIN.
Modules • Edit the quality control shift start time.

• Edit parameters that are specific to a processing module.
Printers • Add a printer.

• Delete a printer.
• Edit printer settings.
Bar Codes • Enable and disable bar code types.

• Configure bar code parameters.
Reagents and Configure reagent and supply low alerts.

Supplies

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Section 2 System configuration
Reports Configure automatic printing of reports.

Abbott Mail • Enable and disable download options for Abbott Mail
items.
• Configure the download language for the Abbott Mail
documentation.
Users screen, page 169
User Profile screen, page 180
Modules screen, page 182
Printers screen, page 191
Bar Codes screen, page 198
Reagents and Supplies screen, page 201
Reports screen, page 211
Abbott Mail screen, page 214
Users screen
On the Users screen, the operator can view the following information for users that have been
created on the system:
• Operator ID
• First and last names
• Access level
• Status
• Date on which a user was created
The system administrator can perform the following functions:

• Create new users.
• Edit a user name, the access level, and the status.
• Reset a user PIN.
• Import and export user data.
The operator can search for a specific user.
Users screen element descriptions, page 170

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Users Import screen, Users Export screen element descriptions, page 171
Descriptions of access levels, page 172
Create New User screen element descriptions, page 173
Create a new user, page 174
Edit User screen element descriptions, page 175
Edit a user, page 176
Inactivate or activate a user, page 177
Set PIN flyout element descriptions, page 177
Import users, page 178
Export users, page 179
Manage user PINs, page 179
Users screen element descriptions

On the Users screen, the user can filter and display user profile information.
Elements
Operator ID Displays the operator ID of the user.
Last Name Displays the last name of the user.
First Name Displays the first name of the user.
Level Displays one of the following access levels for the user:
• General
• Supervisor
• Administrator
Status Displays one of the following statuses for the user:
Active The user can log on to the system if

the status of the user profile is Active.
Inactive The user cannot log on to the system if

the status of the user profile is Inactive.
Created On Displays the date and time that the user profile was created.

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Function buttons
Done Saves changes and either displays the previously viewed

screen or closes the flyout.
Search Displays the Search flyout.
Import Navigates to the Users Import screen.
Export Navigates to the Users Export screen.
Create New User Navigates to the Create New User screen.
Edit User Navigates to the Edit User screen.
Set PIN Displays the Set PIN flyout.
Text Size Increases or decreases the size of text displayed.
Users Import screen, Users Export screen element descriptions

On the Users Import screen, the operator can import users on a USB flash drive. On the Users
Export screen, the operator can export users to a USB flash drive.
Elements
button The Previous Folder button navigates to the previously

selected folder.
button The Selected Folders button displays all previously selected

folders.
Folder name Displays the currently selected folder.
button The Home button navigates to the hard drive folder.
File Name Displays the name of the exported user database file.
Created On Displays the date and time that the exported user database
file was created.

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Import File Displays the file location and file name of the selected
exported user database file. The element is displayed only on
the Users Import screen.
Export Location Displays the drive and folder location to which the exported
user database file is exported. The element is displayed only
on the Users Export screen.
Function buttons

Cancel Cancels selections or entries and displays the previously

viewed screen or flyout.
Import Imports the selected file. This function button is displayed only
on the Users Import screen.
Export Exports the users database. This function button is displayed

only on the Users Export screen.
Text Size This function button is unavailable on this screen.
Descriptions of access levels

An access level is the identifier that controls the access to certain user interface functionality.
The system software has three types of operator access levels:
General operator Used to display the current operator ID on various screens

and to print the operator ID of the current user on printouts
and reports.
Supervisor Used to perform supervisor functions such as the following

examples:
• Configure automatically generated reports.
• Configure quality control settings.
• Configure user-defined maintenance.

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• Configure audio settings.

• Configure calibrator settings.
System administrator Used to perform administrator functions such as the following

examples:
• Configure system settings.
• Approve maintenance logs.
• Install and uninstall assays.
• Accept Abbott Mail items.
Additionally, Abbott Customer Service may provide a user name and a temporary password to
operators who call for troubleshooting assistance. This logon authorizes selected functions in
addition to those functions allowed by the system administrator logon.
Log On screen, page 507
Create New User screen element descriptions

On the Create New User screen, the system administrator can create a new user profile.
Elements
Operator ID Displays a box to enter the operator ID of the new user.
First Name Displays a box to enter the first name of the new user.
Last Name Displays a box to enter the last name of the new user.
Level Displays the following access level options for the new user:
• General
• Supervisor
• Administrator
Status Displays the following status options for the new user:
Active The new user can log on to the system

if this option is enabled.

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Inactive The new user cannot log on to the

system if this option is enabled.
PIN Displays a box to enter the four-digit personal identification

number of the new user.
Re-enter PIN Displays a box to reenter the four-digit personal identification

number of the new user.
Function buttons


Save Saves changes.
Create a new user
Operator access level System administrator
Perform this procedure to create a new user. An operator ID and a PIN must be created for an
operator to log on to the system software and use the system.
1. On the menu bar, tap System, and then tap Configure.
NOTE: The Configure command can be configured as an icon on the menu bar and thereby
is removed from the System menu.
2. On the General tab of the Configure screen, tap Users.
3. On the Users screen, tap Create New User.
4. On the Create New User screen, enter the operator ID.
The operator ID can contain a maximum of 12 alphanumeric characters.
5. Type the first and last names.
6. In the Level area, tap an option for the operator access level.

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7. In the Status area, tap a status option.

8. Enter a unique four-digit PIN.
9. To confirm the PIN, reenter it.
10. To save the new user settings, tap Save.
To delete the new user settings, tap Cancel.
11. To create another new user, repeat steps 4, page 174 through 10, page 175.
12. To return to the Users screen, tap Done.
Edit User screen element descriptions

On the Edit User screen, the system administrator can edit an existing user profile.
Elements
Operator ID Displays the operator ID of the user.
Level Displays the access level of the user. One of the following
options is enabled:
• General
• Supervisor
• Administrator
Status Displays the status of the user. One of the following options is
enabled:
Active The user can log on to the system if

this option is enabled.
Inactive The user cannot log on to the system if

this option is enabled.
Created On Displays the date and time that the user profile was created.
Created By Displays the operator ID of the system administrator who

created the user profile.

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Last Updated On Displays the date and time that the user profile was most
recently edited.
Last Updated By Displays the operator ID of the system administrator who most
recently edited the user profile.
Function buttons


Save Saves changes.
Edit a user
Perform this procedure to edit the first name, the last name, the access level, and the status of
a user.
3. On the Users screen, tap an operator ID to edit.
NOTE: To filter the operator IDs, tap Search.
4. Tap Edit User.
5. On the Edit User screen, edit any of the following information:
– First Name
– Last Name
– Level
– Status

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NOTE: A user cannot edit the level and status of the user's own profile.
6. To save the edits to the user settings, tap Save.
To delete the edits to the user settings, tap Cancel.
Search for or filter data, page 757
Inactivate or activate a user
Perform this procedure to inactivate or activate a user.

3. On the Users screen, tap an operator ID to inactivate or activate.
4. Tap Edit User.
5. In the Status area of the Edit User screen, tap one of the following options:
– Tap Inactive to inactivate a user.
– Tap Active to activate a user.
6. To save the edit to the user settings, tap Save.
To delete the edit to the user settings, tap Cancel.
Set PIN flyout element descriptions

In the Set PIN flyout, the operator can change a user PIN.

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Elements
Changing PIN for Displays the first name, last name, and operator ID of the user
being edited.
Your Operator ID Displays the operator ID of the logged-on user.
Your PIN Displays a box to enter the current four-digit PIN of the
logged-on user.
New PIN Displays a box to enter the new four-digit PIN for the selected
operator ID.
Re-enter New PIN Displays a box to reenter and confirm the new PIN for the
selected operator ID.
Function buttons


? Displays Help from the operations manual for the active

screen, flyout, or message code.
Import users
Required materials USB flash drive with user file to import
Perform this procedure to import users on a USB flash drive.

1. Insert the USB flash drive.

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4. On the Users screen, tap Import.
5. On the Users Import screen, tap the USB flash drive, the folder, and the file to import.
6. Tap Import.
7. When a confirmation message is displayed, tap Yes, and then tap OK.
8. Remove the USB flash drive.
Insert and remove a USB flash drive, page 764
Export users
Required materials USB flash drive
Perform this procedure to export users to a USB flash drive. After the users are exported, the
users can be installed on a different system.
4. On the Users screen, tap Export.
5. On the Users Export screen, tap the USB drive and folder to which to export the user files.
6. Tap Export.
7. When a confirmation message is displayed, tap Yes, and then tap OK.
Manage user PINs

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Perform this procedure to change one or more user PINs. System administrators can change
their personal user PINs and the user PINs of other users.
3. On the Users screen, tap an operator ID to edit.
4. Tap Set PIN.
5. In the Set PIN flyout, enter the following information:
a. Your PIN (the current four-digit PIN of the logged-on system administrator or user)
b. New PIN (a new four-digit PIN for the selected operator ID)
c. Re-enter New PIN (the confirmation of the new PIN for the selected operator ID)
6. To save the edits to the user settings and return to the Users screen, tap Done.
7. When a confirmation message is displayed, tap Yes.
8. To delete the edits to the user settings and return to the Users screen, tap Cancel.
User Profile screen

On the User Profile screen, the operator can perform the following functions:
• Configure a personal display theme.
• Change a personal user PIN.
User Profile screen element descriptions, page 180
Configure a personal display theme, page 182
Change a personal user PIN, page 182
Set PIN flyout element descriptions, page 177
User Profile screen element descriptions

On the User Profile screen, the operator can change the user PIN and the display theme.

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General area
Username Displays the configured operator ID.
Level Displays one of the following access levels:

• General
• Supervisor
• Administrator
Created On Displays the date and time that a user was created.
Display area
Theme Displays the current theme options:
Light Bar Changes the theme bar to a light color.
Dark Bar Changes the theme bar to a dark color.
Function buttons

Set PIN Displays the Set PIN flyout.

NOTE: This function button is available after a user is
selected.
Cancel Navigates to the User Profile message box where previous

edits can be deleted by tapping the Continue button.

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Configure a personal display theme

Perform this procedure to configure a display theme. General operators can configure their
personal display themes but cannot configure the display themes of other users.
2. On the General tab of the Configure screen, tap User Profile.
3. Under Display on the User Profile screen, tap an option in the Theme area.
4. To save the edits to the user profile settings, tap Done.
To delete the edits to the user profile settings, tap Cancel.
Change a personal user PIN

Perform this procedure to change a user PIN. General operators can change their personal user
PINs but cannot change the user PINs of other users.
2. On the General tab of the Configure screen, tap User Profile.
3. On the User Profile screen, tap Set PIN.
4. In the Set PIN flyout, enter the following information:
a. Your PIN (the current four-digit PIN of the logged-on user)
b. New PIN (a new four-digit PIN for the selected operator ID)
c. Re-enter New PIN (the confirmation of the new PIN for the selected operator ID)
5. To save the edits to the user profile settings and return to the User Profile screen, tap
Done.
6. To delete the edits to the user profile settings and return to the User Profile screen, tap
Cancel.
Modules screen
On the Modules screen, the operator can view the following information:
• Serial numbers for each processing module and the reagent and sample manager (RSM)

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• The number of assigned reagent carousel positions for onboard calibrators and controls
• The quality control shift start time
• The location and number of priority sections
• Specific parameters for each processing module and the RSM
• Instrument test cycle counts
The supervisor can edit the quality control shift start time.
• Configure the module name.
• Configure the number of assigned reagent carousel positions for onboard calibrators and
controls.
• Configure the location and number of priority sections.
• Configure specific parameters for each processing module and the RSM.
Modules screen, reagent and sample manager (RSM) element descriptions, page 183
Modules screen, c‑series element descriptions, page 184
Modules screen, i‑series element descriptions, page 187
Configure reagent and sample manager module settings, page 189
Configure c‑series module settings, page 189
Configure i‑series module settings, page 190
Modules screen, reagent and sample manager (RSM) element descriptions

On the Modules screen, the operator can configure module settings for the reagent and sample
manager (RSM).
Module Information area
Module Displays a drop-down list that is used to select a module to

display module-specific information.
Module Type Displays the module type.
Module Name Displays a box that is used to enter a maximum of 12

alphanumeric characters. The box is an optional element.

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Module Details area
Retest Options Displays the Automatically Reposition Samples for Retest

options:
• Yes
• No (default)
When this option is enabled, the RSM is configured to

reposition sample racks for automatic retesting.
Priority Positions Displays the following settings:
Location of Priority Displays the following options:

Positions
• Leftmost: The priority position
location can start at position 1.
• Rightmost: The priority position
location can start at position 25.
Number of Priority Displays a slider that is used to

Positions configure priority positions from 0
through 25 in increments of 5.
Function buttons


Save Saves changes.
Modules screen, c‑series element descriptions

On the Modules screen, the operator can configure Alinity c‑series module settings.

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SN Displays the serial number of the selected module.

Module Details area
Onboard Cal/QC Displays the Onboard Cal/QC Positions drop-down list, which
is used to configure the number of reagent carousel positions
that are available for onboard vial racks. When a reagent
carousel position is configured, the position is unavailable for
cartridge storage. A position from 1 through 4 can be
selected. The default position is 1.
Quality Control Displays the Shift Start Time spin box, which is used to
configure a shift start time and to define quality control runs
with respect to Westgard rules that relate to within-run and
between-run data points. To configure the shift start time, use
the system-configured format (HH:MM) and type the time in
the box or tap the Up Arrow and Down Arrow buttons. If the
system is configured for the 12-hour clock format, tap the AM
or PM button to configure the time of day.
ICT Module Displays the Installed options:

• Yes (default)
• No
Liquid Waste Displays the Installed options:

Container
• Yes
• No (default)
Instrument Test Cycle Displays the following settings:

Counts

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Tests Initiated Count Displays the total number of tests that

are scheduled and either have
completed successfully with results or
have become exceptions.
NOTE: This number excludes derived
results and HIL tests. Integrated chip
technology (ICT) tests count only as
one.
Tests Completed Displays the total number of tests that

Count have completed data reduction and a
valid absorbance (c‑series photometric)
or voltage (c‑series potentiometric) is
generated.
NOTE: This number excludes derived
results and HIL tests. ICT tests count
only as one.
Reagent Coolant Displays the following settings:

Details
Lot Number Displays the lot number of the reagent
supply center coolant.
Replacement Date Displays the date that the reagent

supply center coolant was replaced.
Expiration Date Displays the onboard stability expiration

date of the reagent supply center
coolant.
Function buttons


Save Saves changes.

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Modules screen, i‑series element descriptions

On the Modules screen, the operator can configure Alinity i‑series module settings.

SN Displays the serial number of the selected module.

Module Details area
Onboard Cal/QC Displays the Onboard Cal/QC Positions drop-down list, which
is used to configure the number of reagent carousel positions
that are available for onboard vial racks. When a reagent
carousel position is configured, the position is unavailable for
cartridge storage. A position from 1 through 4 can be
selected. The default position is 1.
Quality Control Displays the Shift Start Time spin box, which is used to
configure a shift start time and to define quality control runs
with respect to Westgard rules that relate to within-run and
between-run data points. To configure the shift start time, use
the system-configured format (HH:MM) and type the time in
the box or tap the Up Arrow and Down Arrow buttons. If the
system is configured for the 12-hour clock format, tap the AM
or PM button to configure the time of day.
Optics Values Displays the following settings:
Normalization Displays a box that is used to enter an

optics normalization value.
Linearity Displays a box that is used to enter an

optics linearity value.
STAT Protocol Displays the STAT Protocol Percentage slider, which is used
to configure the number of reaction vessel positions that are

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allocated for STAT assay protocols. If this percentage does

not reflect the actual number of STAT protocols that were
run, throughput may be decreased.
Instrument Test Cycle Displays the following settings:

Counts
Tests Initiated Count Displays the total number of tests that
are scheduled and either have
completed successfully with results or
have become exceptions.
Tests Completed Displays the total number of tests that

Count have completed data reduction and a
valid relative light unit (RLU) reading is
generated.
Reagent Coolant Displays the following settings:

Details
Lot Number Displays the lot number of the reagent
supply center coolant.
Replacement Date Displays the date that the reagent

supply center coolant was replaced.
Expiration Date Displays the onboard stability expiration

date of the reagent supply center
coolant.
Function buttons


Save Saves changes.

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Configure reagent and sample manager module settings
Required instrument Stopped, Warming, or Idle

status
Perform this procedure to configure reagent and sample manager module settings.
2. On the General tab of the Configure screen, tap Modules.
3. In the Module Name box on the Modules screen, if a name other than the name that is
displayed is needed, type a new module name.
4. Under Retest Options, tap an option to reposition samples for retesting automatically.
5. Under Priority Sections, enter the following information:
– Location of Priority Sections
– Number of Priority Sections
6. To save the edits to the module settings, tap Save.
To delete the edits to the module settings, tap Cancel.
7. To return to the Configure screen, tap Done.
Automated retest of specimens, page 658
Configure c‑series module settings

status
Operator access level System administrator, except where noted
Perform this procedure to configure c‑series module settings.

3. Under Module Information on the Modules screen, tap a c‑series module in the drop-down
list.

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4. In the Module Name box, if a name other than the name that is displayed is needed, type a
new module name.
5. In the Onboard Cal/QC Position drop-down list under Onboard Cal/QC, tap the number of
reagent carousel positions that are assigned to onboard calibrators and controls.
6. In the Shift Start Time box under Quality Control, enter the time for quality controls to be
performed automatically.
NOTE: A supervisor can configure the shift start time.
7. In the Installed area under ICT Module, tap an option.
8. In the Installed area under Liquid Waste Container, tap an option.
Westgard rule run descriptions, page 732
Configure i‑series module settings

status
Perform this procedure to configure i‑series module settings.

3. Under Module Information on the Modules screen, tap an i‑series module in the drop-down
list.
4. In the Module Name box, if a name other than the name that is displayed is needed, type a
new module name.
5. In the Onboard Cal/QC Position drop-down list under Onboard Cal/QC, tap the number of
reagent carousel positions that are assigned to onboard calibrators and controls.
6. In the Shift Start Time box under Quality Control, enter the time for quality controls to be
performed automatically.
NOTE: A supervisor can configure shift start time.
7. Under STAT Protocol, slide the STAT Protocol Percentage button to the right or left to
increase or decrease the STAT percentage.

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8. Under Optics Values, enter the values for Normalization and Linearity that are located on
the optics assembly.
NOTE: Normalization and linearity values need to be updated only when an optics assembly
is replaced.
Printers screen
On the Printers screen, the operator can view information for a configured printer.
• Add a new printer.
• Verify a new printer.
• Change the configuration of an existing printer.
• Configure a printer as the default.
• Access the printer queue.
• Remove a configured printer from the software.
Printers screen element descriptions, page 191
Add Printer flyout, Edit Printer flyout element descriptions, page 193
Printer Verification flyout element descriptions, page 194
Printer Queue flyout element descriptions, page 194
Add a printer, page 195
Edit a printer, page 196
Verify a printer, page 197
Change the default printer, page 197
Remove a printer, page 198
Printers screen element descriptions

On the Printers screen, the system administrator can configure or edit new or existing printers.

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Elements
Name Displays the name of each configured printer.
IP Address Displays the Internet protocol address for the printer.
Verified User Displays the identification of the operator who verified the
printer operation.
Verified Date Displays the date and time of the last successful verification
of the printer operation.
Paper Size Displays the paper size configured for the printer: A4 or
Letter.
Duplex Displays a check mark if the printer is configured to print on

both sides (duplex). If the printer is configured to print on one
side (simplex), no check mark is displayed.
Default Displays a check mark if the printer is configured as the

default printer.
Status Displays one of the following statuses for the printer: OK or

Error.
Function buttons

Add Printer Displays the Add Printer flyout.
Edit Printer Displays the Edit Printer flyout.
Verify Printer Displays the Printer Verification flyout.
Make Default Used to select a default printer if more than one printer is
configured. A check mark is displayed in the Default column
in the row of the default printer. Only one printer can be
configured as the default. If only one printer is configured, the
system designates the printer as the default printer.
Printer Queue Displays the Printer Queue flyout.

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Remove Printer Displays a message that requests confirmation to delete a

configured printer. Any print jobs in the printer queue are
deleted. If the currently configured default printer is deleted,
the system designates the most recently configured printer in
the list as the new default printer. Printer drivers are not
deleted.
Add Printer flyout, Edit Printer flyout element descriptions

In the Add Printer flyout, the operator can configure a new printer. In the Edit Printer flyout, the
operator can edit printer information for an existing printer. A maximum of five printers can be
configured.
Elements
Name Displays a box that is used to enter a unique printer name.

The printer name can have from 1 through 20 characters.
IP Address Displays a box that is used to enter the Internet protocol

address for a new printer.
Paper Size Displays the following options:

• A4
• Letter
Print on Both Sides Displays a check box that is used to enable printing on both
sides (duplex) or on one side (simplex) of the paper.
Driver Displays a list of the printer drivers that are installed on the
system. A printer driver can be selected when a new printer is
added.
Function buttons


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Printer Verification flyout element descriptions

The Printer Verification flyout displays a verification report that can be printed. The printed
verification report can be compared to a report that is displayed to verify a printer.
Elements
Print Options Displays the print options for the Printer Verification flyout.
Report Selection Displays a list of the reports that are available to print. A
preview of the selected report is displayed before the report is
printed.
Function buttons


Print Prints the selected report.

Printer Queue flyout element descriptions

The Printer Queue flyout provides information about individual jobs in the printer queue for the
selected printer. A printer queue is displayed for each configured printer.

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Elements
Printer Displays the name of the selected printer.
Status Displays one of the following statuses for the print request:
Queued, Printing, Error, Deleting, or Out of Paper.
Operator ID Displays the identification of the operator who submitted the

print request.
Date Displays the date and time that the print request was
submitted to the printer queue.
Document Displays the name of the document in the printer queue.
Pages Displays the number of pages for the document in the printer
queue.
Size Displays the size of the document in the printer queue.
Function buttons

Delete All Deletes all print requests from the printer queue.
Delete Selected Deletes selected print requests from the printer queue.

Add a printer
Perform this procedure to add a printer.


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2. On the General tab of the Configure screen, tap Printers.

3. On the Printers screen, tap Add Printer.
4. In the Add Printer flyout, enter the following information:
– Name
– IP Address
NOTE: Use the following format for the IP address: xxx.xxx.xxx.xxx
– Paper Size
– Print on Both Sides
– Driver
NOTE: Choose a universal or generic driver for the type of printer.
5. To add the printer, tap Done.
To return to the Printers screen without adding the printer, tap Cancel.
After the new printer is added, the printer must be verified before it is available to print a report
or document.
Verify a printer, page 197
Edit a printer
Perform this procedure to edit the printer settings for a configured printer.
3. In the list on the Printers screen, tap a printer.
4. Tap Edit Printer.
5. In the Edit Printer flyout, edit any of the following information:
– Name
– IP Address
– Paper Size
– Print on Both Sides

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6. To save the edits to the printer settings, tap Done.

To delete the edits to the printer settings, tap Cancel
Verify a printer
Perform this procedure when a new printer is added. After the new printer is added, the printer
must be verified before it is available to print a report or document.
4. Tap Verify Printer.
5. Under Report Selection in the Printer Verification flyout, tap Printer Verification Report.
6. Tap Print.
7. Compare the printed report to the report that is displayed in the Printer Verification flyout.
NOTE: The printed report and the displayed report must contain the same information. Be
sure that the two reports do not contain truncations, missing or cutoff borders, or any loss of
information. If the two reports do not contain the same information, the printer is not verified.
NOTE: To adjust the size of the text in the displayed report, tap the Text Size button.
8. Tap Done.
9. When a confirmation message is displayed, tap one of the following buttons:
– Tap Yes if the printed report and the displayed report are identical.
– Tap No if the printed report and the displayed report are not identical.
Add a printer, page 195
Change the default printer

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Perform this procedure to change the default printer.

4. Tap Make Default.
Remove a printer
Perform this procedure to remove a printer.

4. Tap Remove Printer.
NOTE: If the printer that was removed is the default printer, the most recently configured
printer in the list becomes the default printer.
Bar Codes screen

On the Bar Codes screen, the operator can view the following information:
• Sample bar code types that are enabled or are disabled
• Configuration settings for each bar code type

• Enable or disable sample bar code types.

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• Configure checksums.
• Configure the transmission of checksum digits to the user interface (UI) computer.
• Configure the transmission of start and stop characters to the UI computer.
• Configure primary and secondary code lengths.
Bar Codes screen element descriptions, page 199
Change sample bar code settings, page 200
Bar Codes screen element descriptions

On the Bar Codes screen, the operator can configure bar code symbology settings.
Elements
Bar Codes Displays the following bar code options:

• Code 128
• Code 39
• Interleaved 2 of 5
• Codabar
Bar Code Type Displays the following options for bar code types:
• Enabled
• Disabled
NOTE: Code 128 cannot be disabled.
Checksums Displays the following options for checksums if the selected

bar code type supports checksums:
• Enabled
• Disabled
Send Checksums to Used to specify whether the checksums are sent to the user
UI Computer interface (UI) computer if the selected bar code type supports
it.
Send Start/Stop Used to specify whether the start and stop characters are
Characters to UI sent to the UI computer if the selected bar code type supports
Computer it.

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Primary Code Length Used to specify the length for the primary bar code. The
range is from 2 through 20 with an incremental value of 2.
The default is 10.
Secondary Code Used to specify the length for the secondary bar code if a
Length second code length is necessary. The range is from 2 through
20 with an incremental value of 2. The default is 8.
Function buttons
Done Saves changes and displays the previously viewed screen.

Save Saves changes.
Change sample bar code settings
Required instrument Reagent and sample manager: Stopped, Warming, or Idle

status
Perform this procedure to change the sample bar code settings.

NOTE: For Code 128 symbology, the option is enabled and does not require additional
configuration.
2. On the General tab of the Configure screen, tap Bar Codes.
3. On the Bar Codes screen, for Code 39, Codabar, and Interleaved 2 of 5 symbologies, tap
the Bar Code Type option to enable or disable the bar code type.
4. For Code 39, Codabar, and Interleaved 2 of 5 symbologies, tap the Checksums option to
enable or disable checksums.
5. For Codabar symbology, if the checksums are enabled, tap the Send Checksums to UI
Computer check box to send the checksums to the user interface (UI) computer.

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6. For Codabar symbology, if the checksums are enabled, tap the Send Start/Stop Characters
to UI Computer check box to send start and stop characters to the UI computer.
7. For Interleaved 2 of 5 symbology, edit the following settings:
– Primary Code Length
– Secondary Code Length
8. To save the edits to the bar code settings, tap Save.
To delete the edits to the bar code settings, tap Cancel.
Sample bar code label guidelines, page 469
Reagents and Supplies screen

On the Reagents and Supplies screen, the operator can view reagent and supply settings.
• Configure the ability to run controls for each reagent lot or reagent cartridge.
• Configure the default reagent low alert for all immunoassay reagents and clinical chemistry
reagents.
• Configure the ability to run reagents that are beyond the reagent onboard stability expiration
and the reagent lot expiration.
• Configure reagent low alert settings for individual reagents.
• Configure low alert settings for bulk solutions.
• Configure the ability to use supplies that are beyond the supply stability expiration and the
supply lot expiration.
The system administrator can also perform the following functions only for c‑series modules:
• Configure the ability to run calibrations for each reagent lot or reagent cartridge.
• Configure low alert settings for onboard diluents and onboard solutions.
• Configure which module in a multimodule system uses Detergent B.
Reagents and Supplies screen, Reagents/Diluents tab element descriptions, page 202
Reagents and Supplies screen, Supplies tab element descriptions, page 205
Configure system level reagent settings, page 207
Configure diluent low alert settings (c‑series), page 208

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Configure individual c‑series reagent settings, page 209

Configure individual i‑series reagent settings, page 209
Configure supply settings, page 210
Print a 1D reagent bar code report (c‑series), page 630
Reagents and Supplies screen, Reagents/Diluents tab element descriptions

The Reagents/Diluents tab is used to configure reagent options, diluent options, and supply low
alerts.
System Level Options area
Override Reagent Used to override a reagent's onboard stability.

Stability
The following options are available:
• On
• Off (default)
Override Reagent Lot Used to override a reagent's expiration.

Expiration
• On
• Off (default)
Run Controls for Displays the options that are used to specify which reagent
Onboard Reagents by cartridge to run for quality control:
Lot Runs the controls only on one cartridge

for each lot (default)
Cartridge Runs the controls for all cartridges in a

lot
NOTE: If the control option is changed, the control option

does not change in the assay parameters for individual assays
that are currently installed. This change affects only the new
assay files that are installed or are imported.
Default Assay Displays a box that is used to enter the amount of time in
Calibration Interval hours that the calibration is valid. A value from 0 through 9999
can be entered. The default value is 720 hours. If 0 is
entered, the calibration interval is not tracked.
NOTE: If the calibration interval is changed, the calibration
interval does not change in the assay parameters for

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individual assays that are currently installed. This change

affects only the new assay files that are installed or are
imported.
Default i‑series Displays a box that is used to enter the reagent low alert for
Reagent Low Alert all i‑series reagents. The notification is displayed when the
number of remaining tests falls below the defined value.
Default c‑series Displays a box that is used to enter the reagent low alert for
Reagent Low Alert all c‑series reagents. The notification is displayed when the
number of remaining tests falls below the defined value.
Diluent Low Alert area
Diluent Displays the name of the diluent.
Low Alert (Percent) Displays a box that is used to enter the diluent low alert
percentage. The notification is displayed when the percent
volume level falls below the defined value:
• Range: 1% to 50%
• Default: 20%
NOTE: If the diluent low alert percentage is changed, the

status of all onboard diluents is reevaluated.
c‑series Reagents tab
Reagent Displays a list of assay names that are configured on the

system.
Calibrate Reagent By Displays the options that are used to calibrate an assay:
Lot Calibrates according to the lot number

of the reagent
Cartridge Calibrates each reagent cartridge

according to the assay
Reagent Low Alert Displays the boxes that are used to enter the reagent low
(Test Count) alert for individual assays. The notification is displayed when
the number of remaining tests for all onboard kits for a
specific reagent falls below the defined value. The default for
c‑series tests is 100.

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Alert Low Value Displays the low alert that is used by an assay:
System Uses the system low alert value
Reagent Uses the individual reagent low alert

value
i‑series Reagents tab
Reagent Displays a list of assay names that are configured on the

system.
Reagent Low Alert Displays the boxes that are used to enter the reagent low
(Test Count) alert for individual assays. The notification is displayed when
the number of remaining tests for all onboard kits for a
specific reagent falls below the defined value. The default for
i‑series tests is 50.
Alert Low Value Displays the low alert that is used by an assay:
System Uses the system low alert value
Reagent Uses the individual reagent low alert

value
Function buttons


Save Saves changes.
Print 1D Bar Code Displays the Print 1D Bar Code flyout. This function button is
available only for user-defined assays and diluents.

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Reagents and Supplies screen, Supplies tab element descriptions

The Supplies tab is used to configure supply options and low alerts.
Elements
Supply Options
i‑series Supply
Options Override Stability Used to override the i‑series bulk
solutions stability dates.
• On
• Off (Default)
Override Lot Used to override the bulk solutions lot

Expiration expiration date.
• On
• Off (Default)
c‑series Supply
Options Override Stability Used to override the c‑series bulk
solutions stability dates.
• On
• Off (Default)
Override Lot Used to override the bulk solutions lot

Expiration expiration date.
• On
• Off (Default)
Override ICT Module Used to override the ICT module

Expiration expiration.
• On

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• Off (Default)
c‑series Onboard Displays the c‑series onboard solutions by module.

Solutions
Supply Low Alerts
i‑series Bulk Solutions Displays text boxes that are used to enter low alert level
percentages of the i‑series bulk solutions: Wash Buffer,
Trigger, and Pre-Trigger. The notification is displayed when
the volume falls below the defined value:
• Range: 1% to 50%
• Default: 20%
c‑series Bulk Displays text boxes that are used to enter low alert level
Solutions percentages of the c‑series bulk solutions: ICT Reference
Solution, Alkaline Wash, and Acid Wash. The notification is
displayed when the volume falls below the defined value:
• Range: 1% to 50%
• Default: 20%
c‑series Onboard Displays text boxes that are used to enter low alert level
Solutions percentages of the c‑series onboard solutions: Sample-Acid
Probe Wash, Sample-Detergent A, Reagent-Acid Probe Wash,
Reagent-Detergent A, and Reagent-Detergent B. The
notification is displayed when the volume falls below the
defined value:
• Range: 1% to 50%
• Default: 20%
Function buttons


Save Saves changes.

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Configure system level reagent settings

status
Perform this procedure to configure the following system level reagent settings:
• The option to run controls for each reagent lot or each reagent cartridge
• The option to run reagents that are beyond the reagent onboard stability expiration and the
reagent lot expiration
• Reagent low alert settings for all immunoassay reagents and clinical chemistry reagents

2. On the General tab of the Configure screen, tap Reagents and Supplies.
3. Under System Level Options on the Reagents and Supplies screen, configure the following
override options:
– Override Reagent Stability
– Override Reagent Lot Expiration
NOTE: Running the system with overridden reagents is not recommended except when
troubleshooting is required. All results that are generated from overridden reagents are
flagged with an EXP result flag.
4. Tap one of the following Run Controls for Onboard Reagents by options:
– Lot: Run controls only on one cartridge for each lot.
– Cartridge: Run controls for all cartridges in a lot.
NOTE: If the control option is changed, the control option does not change in the assay
parameters for individual assays that are currently installed. This change affects only the
new assay files that are installed or are imported.
5. In the Default Assay Calibration Interval box, type the number of hours that a calibration
curve is valid.
NOTE: The default assay calibration interval is applied to assays that do not have a defined
calibration interval in the assay file during assay installation. If the calibration interval is
changed, the calibration interval does not change in the assay parameters for individual

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assays that are currently installed. This change affects only the new assay files that are
installed or are imported.
6. In the Default i-series Reagent Low Alert box, type the number of remaining tests that
trigger the low alert status for all i‑series reagents.
7. In the Default c-series Reagent Low Alert box, type the number of remaining tests that
trigger the low alert status for all c‑series reagents.
8. To save the edits to the reagent settings, tap Save.
To delete the edits to the reagent settings, tap Cancel.
Configure diluent low alert settings (c‑series), page 208
Configure individual c‑series reagent settings, page 209
Configure individual i‑series reagent settings, page 209
Configure diluent low alert settings (c‑series)

status
Perform this procedure to configure low alert settings for c‑series onboard diluents.
3. Under Diluent Low Alert on the Reagents and Supplies screen, for the appropriate diluent,
edit the remaining low alert percentage that triggers the low alert status.

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Configure individual c‑series reagent settings

status
Perform this procedure to configure the following individual c‑series reagent settings:
• The option to run calibrations for each reagent lot or each reagent cartridge
NOTE: If this setting is changed for c‑series user-defined assays, both active and inactive
calibration data is deleted.
• Reagent low alert settings for individual c‑series reagents

3. On the Reagents and Supplies screen, tap the c-series Reagents tab.
4. For each appropriate reagent under Calibrate Reagent By on the c-series Reagents tab,
tap one of the following options:
– Lot: Run calibrations only on one cartridge for each lot.
– Cartridge: Run calibrations for all cartridges in a lot.
5. For each appropriate reagent under Reagent Low Alert (Test Count), edit the number of
remaining tests that trigger the low alert status.
Configure individual i‑series reagent settings

status
Perform this procedure configure reagent low alert settings for individual i‑series reagents.

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3. On the Reagents and Supplies screen, tap the i-series Reagents tab.
4. For each appropriate reagent under Reagent Low Alert (Test Count) on the i-series
Reagents tab, edit the number of remaining tests that trigger the low alert status.
Configure supply settings

status
Perform this procedure to configure the following supply settings:

• Low alert settings for bulk solutions and onboard solutions
• The option to run supplies that are beyond the supply onboard stability expiration and the
supply lot expiration
• The c‑series modules that use Detergent B

3. On the Reagents and Supplies screen, tap the Supplies tab.
4. Under Supply Options on the Supplies tab, configure the following override options:
– i-series Supply Options:
• Override i-series Stability
NOTE: The system tracks onboard stability for Pre-Trigger Solution and Trigger
Solution.
• Override i-series Lot Expiration
– c-series Supply Options

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• Override c-series Stability

NOTE: The system tracks onboard stability for sample onboard wash solutions,
Detergent B, and Acid Probe Wash.
• Override c-series Lot Expiration
• Override ICT Module Expiration
5. Under c-series Onboard Solutions, tap the check box for each module that uses Detergent
B.
6. For each appropriate supply under Supply Low Alerts, edit the remaining percentage that
triggers the low alert status.
7. To save the edits to the supply settings, tap Save.
To delete the edits to the supply settings, tap Cancel.
Reports screen
On the Reports screen, the operator can view settings for automatically generated reports.
The operator can configure print screen output options.
The supervisor can configure settings for automatically generated reports.
The system administrator can configure a facility name to display on each report.
Reports screen element descriptions, page 211
Configure report settings, page 213
Configure the print screen file output destination, page 213
Reports screen element descriptions

On the Reports screen, the operator can generate reports automatically and can identify the
print screen output.
Automatic Report Generation area

This area is used to enable automatic printing of the Sample Laboratory Report, the Result List
Report (Released), the Calibration Details Report, and the Procedure Report (Maintenance). This
area provides three automatic printing options:
• Off (default)
• Default Printer

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• Save to File
If the Save to File option is selected, the Sample Laboratory File Location box is displayed to
enter the drive and folder where the file is saved. The Browse button is used to select the drive
and folder location.
Sample Laboratory Automatically prints the Sample Laboratory Report after all
results for a sample are released.
Results List Automatically prints the Result List Report for released results
based on one of the following criteria:
• 15 results
• 15 minutes
Calibration Details Automatically prints the Calibration Details Report after a

calibration is generated and becomes active.
Maintenance Automatically prints the Procedure Report when a

Procedure maintenance procedure is completed.
Site Name Displays a text box that is used to enter the facility name to
display on each report.
Print Screen area
Send Print Screen Displays options that are used to select the destination of a
Output To generated print screen:
• Default Printer
• Save to File (default)
Function buttons


Save Saves changes.

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Configure report settings
Operator access level Supervisor, except where noted
Perform this procedure to configure report settings.

2. On the General tab of the Configure screen, tap Reports.
3. Under Automatic Report Generation on the Reports screen, enter the following information:
– Sample Laboratory Report
– Result List Report
– Calibration Details Report
– Maintenance Procedure Report
– Site Name
NOTE: The site name must be configured by a system administrator.
4. Under Print Screen, tap one of the following Send Print Screen Output To options:
– Default Printer
– Save to File
NOTE: The print screen output can be configured by a general operator.

5. To save the edits to the report settings, tap Save.
To delete the edits to the reports settings, tap Cancel.
Procedure Report element descriptions, page 1671
Configure the print screen file output destination

Perform this procedure to configure when a print screen file is generated, to print the file to
default printer, or to save a copy of the file to a USB flash drive.

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2. On the General tab of the Configure screen, tap Reports.
3. Under Print Screen on the Reports screen, tap one of the following Send Print Screen
Output To options:
– Default Printer
– Save to File
4. To save the edit to the print screen file output destination, tap Save.
To delete the edit to the print screen file output destination, tap Cancel.
Print a screen image, page 756
Abbott Mail screen

On the Abbott Mail screen, the operator can view the Abbott Mail download options.
• Enable or disable Abbott Mail items that can be downloaded automatically.
• Configure the download language for the Abbott Mail documentation.
Abbott Mail screen element descriptions, page 214
Configure Abbott Mail settings, page 216
Abbott Mail screen element descriptions

On the Abbott Mail screen, the operator can configure download and language options.
Elements
Download Options
Automatically Used to configure download options for the following items:

Download
Assay Files • Enable: Requests for assay file
updates are sent automatically.
(Default)

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• Disable: Requests for assay file

updates are not sent automatically.
Assay Inserts • Enable: Requests for assay inserts

are sent automatically when a
reagent is scanned. (Default)
• Disable: Requests for assay
inserts are not sent automatically
when a reagent is scanned.
Assay Insert • Enable: Requests for a new assay

Notifications insert are sent automatically.
(Default)
• Disable: Requests for a new assay
insert are not sent automatically.
Calibrator Data • Enable: Requests for calibrator

value assignment updates are sent
automatically. (Default)
• Disable: Requests for calibrator
value assignment updates are not
sent automatically.
Download Language Displays a drop-down list that is used to specify a language

for Abbott Mail from a set of available languages.
Function buttons


Save Saves changes.

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Configure Abbott Mail settings
Operator access level System Administrator
Perform this procedure to configure Abbott Mail settings.

2. On the General tab of the Configure screen, tap Abbott Mail.
3. Under Download Options on the Abbott Mail screen, enable or disable automatic
downloads for the following Abbott Mail items:
– Assay Files
– Assay Inserts
– Assay Insert Notifications
NOTE: If the assay insert notifications are disabled, assay inserts are assigned
automatically to the new reagent lot without being displayed on the Abbott Mail screen.
The assay insert status is Current.
– Calibrator Data
4. In the Download Language drop-down list, tap the language for the Abbott Mail
documentation.
5. To save the edits to the Abbott Mail settings, tap Save.
To delete the edits to the Abbott Mail settings, tap Cancel.
Configure screen, Computer tab

The operator can perform the following tasks from the Computer tab of the Configure screen:
General Settings Configure the following settings:

• Date and time
• Number format
• Speaker volume
• System name

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• System language
• Online help language
• Screen time-out
• The disabling of sample processing when a maintenance
procedure is overdue
• Authentication requirement for a general user logon
Audio Settings Configure the sound for various alerts.
Host Setup Configure the following settings:

• Host interface options
• Host transmission options
• Specimen and control release modes
HL7 Communication Configure the following settings:

• Message headers
• Sender channel
• Test HL7 communication
ASTM Communication Configure the following settings:

• ASTM channel settings
• Test ASTM communication
LAS Communication Configure the following settings:

• Laboratory automation system configuration
• Sender channel
Shortcuts Configure user-defined System menu commands as icons on

the menu bar.
Automatic Backup Configure automatic backup options.

Alinity PRO • Enable or disable inventory sharing.
• Enable or disable status update messages.
• Configure status update message settings.
AbbottLink View AbbottLink settings.

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Distance Alert Enable or disable the following options:

• Distance alert
• Notification options
General Settings screen, page 218
Audio Settings screen, page 223
Host Setup screen, page 225
HL7 Communication screen, page 229
ASTM Communication screen, page 232
LAS Communication screen, page 234
Shortcuts screen, page 236
Automatic Backup screen, page 238
Alinity PRO screen, page 241
AbbottLink screen, page 243
Distance Alert screen, page 245
General Settings screen

On the General Settings screen, the operator can view the following information:
• Date and time zone
• Number format
• System information
The operator can configure the speaker volume.

• Configure system date and time settings.
• Configure the number format.
• Adjust the speaker volume.
• Configure the system name and the system language.
• Configure the online help language.
• Configure the Log On screen time-out setting.
• Enable or disable instrument processing when maintenance is overdue.
• Configure the system to require authentication for the general operator logon.

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General Settings screen element descriptions, page 219
Configure general settings, page 221
General Settings screen element descriptions

The General Settings screen displays the date and time zone, the number format, the speaker
volume, and the system information.
Date/Time Zone area
System Date Displays a box that is used to edit the system date.
Date Format Displays the options that are used to edit the system date
format:
• MM.DD.YYYY (default)
• DD.MM.YYYY
• YYYY.MM.DD
Time Zone Displays a drop-down list that is used to select the area-
specific time zone.
System Time Displays a spin box that is used to edit the system time. To
edit the system time, use the system-configured format
(HH:MM) and type the time in the box or tap the Up Arrow
and Down Arrow buttons. If the system is configured for the
12-hour clock format, tap the AM or PM button to configure
the time of day.
Time Format Displays the following options:

• 12-hour clock
• 24-hour clock
NOTE: If any other language is changed to English, the time

format is automatically changed from the 24-hour clock
format to the 12-hour clock format.
Automatically Adjust Displays a check box that is used to adjust the clock
Clock for Daylight automatically for Daylight Saving Time.
Saving Time

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Number Format area
Thousand/Decimal Displays the options that are used to edit the number format
Separator for the thousands and decimal separator:
• Comma and Period (1,000,000.00) (default)
• Period and Comma (1.000.000,00)
• None and Period (1000000.00)
• None and Comma (1000000,00)
Speaker Volume area
Speaker Volume Displays a slider that is used to adjust the speaker volume
from 0 through 10.
NOTE: This setting is available only if the system is
configured with speakers.
System Information area
System Name Displays a box that is used to edit the system name.
SCM Serial Number Displays the serial number of the system control module.
System Language Displays a drop-down list that is used to select the system
language.
NOTE: If any other language is changed to English, the time
format is automatically changed from the 24-hour clock
format to the 12-hour clock format.
Online Help Language Displays a drop-down list that is used to select the online help
language.
Log On Screen Time- Displays a box that is used to edit the setting for the screen
out time-out:
• Range is from 0 minutes through 60 minutes.
• Default is 15 minutes.
NOTE: If the time-out is configured as zero, the system does

not track inactivity.

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Disable Sample Displays a check box that is used to disable sample

Processing When processing if maintenance is overdue. For the default setting,
Maintenance Is the check box is selected.
Overdue
Require Displays a check box that is used to require a user PIN for a
Authentication For general operator logon. For the default setting, the check box
General Operator is selected.
Function buttons


Save Saves changes.
Configure general settings
Required instrument Stopped, Warming, or Idle, except where noted

status
Perform this procedure to configure the general settings for the system.
2. On the Configure screen, tap the Computer tab.
3. On the Computer tab of the Configure screen, tap General Settings.
4. Under Date/Time Zone on the General Settings screen, enter the following information:
– System Date
– Date Format
– Time Zone

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– System Time
– Time Format
– Automatically Adjust Clock for Daylight Saving Time
NOTE: When any of the Date/Time Zone settings are changed, the user interface (UI)
computer shuts down and restarts.
5. Under Number Format, tap an option in the Thousand/Decimal Separator area.
NOTE: When the number format is changed, the UI computer shuts down and restarts.
6. Under Speaker Volume, slide the Speaker Volume button to the right or left to increase or
decrease the speaker volume.
NOTE: The speaker volume can be configured at any operator level and in any instrument
status.
7. Under System Information, enter the following information:
– System Name
– System Language
NOTE: The system language can be configured at any operator level. When the system
language is changed, the UI computer shuts down and restarts.
NOTE: If any other language is changed to English, the time format is automatically
changed from the 24-hour clock format to the 12-hour clock format.
– Online Help Language
NOTE: The online help language can be configured at any operator level and in any
instrument status.
The online help language is the same as the system language unless the operator
changes the online help language to a different language. When the online help
language is changed, the system retains the online help language independent of the
system language.
– Disable Sample Processing When Maintenance Is Overdue
– Log On Screen Time-Out
NOTE: The Log On screen time-out can be configured in any instrument status.
– Require Authentication for General Operator
NOTE: Required authentication can be configured in any instrument status.
8. To save the edits to the general settings, tap Save.
To delete the edits to the general settings, tap Cancel.

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Cycle power to the processing module and the reagent and sample manager (RSM), page 484
Import a translated version of the operations manual, page 394
Audio Settings screen

On the Audio Settings screen, the operator can view the following information:
• Audio alert global settings
• Message alert settings
The supervisor can perform the following functions:

• Enable or disable global settings for audible alerts.
• Configure the alert volume.
• Configure a unique audible alert for critical messages.
• Configure a unique audible alert for alert messages.
• Configure a unique audible alert for notification messages.
Audio Settings screen element descriptions, page 223
Configure audio settings, page 224
Audio Settings screen element descriptions

The Audio Settings screen displays the audio and message alert settings.
Global Settings area
Turn Off All Audio Displays a check box that is used to disable all audio alerts
Alerts on the system. For the default setting, the check box is
selected.
Alert Volume Displays a slider that is used to adjust the volume of all audio
alerts from 0 through 10. The default setting is 5.
Message Alert Settings area

Displays settings that are used to select a sound for the following message types:
• Critical
• Alert
• Notification

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Critical, Alert, Displays a drop-down list for each message type that is used
Notification to select an available sound.
Repeat Displays a drop-down list that is used to select the number of

times for an alert to repeat. The alert can repeat from 0 times
through 20 times or continuously for the selected message
type.
Play Displays a button that is used to preview the audio alert

before the setting is saved.
Function buttons


Save Saves changes.
Configure audio settings
Operator access level Supervisor
Perform this procedure to configure the audio settings for the system.
3. On the Computer tab of the Configure screen, tap Audio Settings.
4. Under Global Settings on the Audio Settings screen, enter the following information:
– Tap the Turn Off All Audio Alerts check box to enable or disable audio alerts.
– Slide the Alert Volume button to the right or left to increase or decrease the alert
volume.

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5. Under Message Alert Settings, enter the following information for each message category:
– Tap the audio sound in the message category drop-down list.
– Tap the number of times to repeat the audio sound in the Repeat drop-down list.
NOTE: To hear a sample of the selected sound, tap the Play button next to the drop-down
list.
6. To save the edits to the audio settings, tap Save.
To delete the edits to the audio settings, tap Cancel.
Host Setup screen

On the Host Setup screen, the operator can view the following information:
• Interface options
• Transmission options
• Result release mode options

• Configure interface and query mode options.
• Configure transmission options for specimen, control, calibrator, sample status, and test
status.
• Configure result release mode options for specimen and control.
Configure host settings, page 228
Host Setup screen element descriptions

The Host Setup screen displays the interface, transmission, and result release settings.
Interface Options area

Displays options that are used to configure host interface communication.
Host Interface Displays options that are used to configure the system to
receive orders from and transmit results to a host computer:

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• HL7
• ASTM
• Off (default)
Query Mode Displays options that are used to configure the system to
send queries for orders to the host computer:
• On
• Off (default)
Query Time-Out Displays the maximum time period that the system waits for
Seconds the host computer to respond to a query. The range is from
5 seconds through 60 seconds. The default is 10 seconds.
Transmission Options area

Displays options that are used to define the method for transmitting the released results to the
host computer.
NOTE: The transmission options Calibration, Sample Status, Test Status, Assay Availability,
and Assay Availability Time Interval Minutes are available only if the Host Interface option is
configured for HL7.
Specimens Displays the following options:

• Single
• Collated (default)
• Collated by Module (This option is available only for a
multimodule system.)
Control Displays the following options:

• Single
• Collated (default)
• Collated by Module (This option is available only for a
multimodule system.)
• Off
Calibration Displays the following options:

• On
• Off (default)

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Sample Status Displays options that are used to configure the system to
send sample status information to the host interface:
• On
• Off (default)
Test Status Displays options that are used to configure the system to
send test status information to the host interface:
• On
• Off (default)
Assay Availability Displays options that are used to configure the system to
send assay availability information for each module to the
host interface:
• On
• Off (default)
Assay Availability Displays a box that is used to enter in minutes how often the
Time Interval Minutes Alinity system sends assay availability information to the host
interface. The status update interval is a range from 1 minute
through 10 minutes. The default is 1 minute.
Result Release Mode Options area

Displays options that are used to configure the release mode for specimens, controls, and
exceptions. The following options are available for each result type:
• Manual (default)
• Automatic
• Automatic with Exceptions
• Hold
NOTE: When the Hold option is selected, the operator can configure to hold results for each
type of specimen result flag.
Function buttons



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Save Saves changes.
Descriptions of specimen result flags, page 722
Descriptions of quality control result flags, page 724
Configure host settings
Prerequisite HL7 communication or ASTM communication must be

configured before the host interface type is selected.
Required instrument Any instrument status, except where noted

status
Perform this procedure to configure the host settings for the system.
3. On the Computer tab of the Configure screen, tap Host Setup.
4. Under Interface Options on the Host Setup screen, enter the following information:
– Host Interface
NOTE: To configure Host Interface, the required instrument status is Stopped,
Warming, or Idle.
– Query Mode
– Query Time-Out Seconds
5. Under Transmission Options, enter the following information:
– Specimen
NOTE: To configure Specimen, the required instrument status is Stopped, Warming, or
Idle.
– Control
– Calibrator
– Sample Status

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– Test Status
– Assay Availability
– Assay Availability Time Interval Minutes
NOTE: The transmission options Calibrator, Sample Status, Test Status, Assay
Availability, and Assay Availability Time Interval Minutes are available only if the Host
Interface option is configured for HL7.
6. Under Result Release Mode Options, enter the following information:
NOTE: To configure Result Release Mode Options, the required instrument status is
Stopped, Warming, or Idle, and unreleased results and unreleased exceptions must be
released.
– Specimen
– Control
NOTE: When the Hold option is selected for either Specimen or Control, the operator can
configure to hold results for each type of specimen result flag or quality control flag.
7. To save the edits to the host settings, tap Save.
To delete the edits to the host settings, tap Cancel.
Edit result settings of assay parameters, page 297
Host orders, page 652
Verify the HL7 communication, page 1466
Verify the ASTM communication, page 1468
HL7 Communication screen

On the HL7 Communication screen, the operator can view the following information:
• Message headers
• Sender channel options
• Receiver channel options

• Configure message headers.
• Configure sender channels.
• Test HL7 communication settings.

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HL7 Communication screen element descriptions, page 230
Configure HL7 communication settings, page 231
HL7 Communication screen element descriptions

On the HL7 Communication screen, the operator can configure the host communications settings
for the system.
Message Headers area
MSH-3 Sending Displays a text box that is used to enter the MSH-3 Sending
Application Application for HL7 host messaging for a maximum of 20
alphanumeric characters.
MSH-4 Sending Displays a text box that is used to enter the MSH-4 Sending
Facility Facility for HL7 host messaging for a maximum of 20
MSH-5 Receiving Displays a text box that is used to enter the MSH-5 Receiving
Application Application for HL7 host messaging for a maximum of 20
MSH-6 Receiving Displays a text box that is used to enter the MSH-6 Receiving
Facility Facility for HL7 host messaging for a maximum of 20
Sender Channel area
Connection Type Displays the following options:

• Active Transient (default)
• Active Persistent
IP Address Displays a text box that is used to enter the Internet protocol
(IP) address when the Active Transient or Active Persistent
option is selected. The IP address is configured as four
decimal numbers. The range for each number is from 0
through 255 and is separated by periods (supports the IPv4
address).
Port Number Displays a text box that is used to enter the port number. The
port number range is from 0 through 65535.

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Receiver Channel area
Port Number Displays the port number.
Function buttons


Save/Test Tests previously defined settings and saves changes.
Configure HL7 communication settings
Required instrument Stopped, Warming, or Idle, except where noted

status
Perform this procedure to configure the HL7 communication settings for the system.
3. On the Computer tab of the Configure screen, tap HL7 Communication.
4. Under Message Headers on the HL7 Communication screen, enter the following
information:
– MSH-3 Sending Application
– MSH-4 Sending Facility
– MSH-5 Receiving Application
– MSH-6 Receiving Facility
NOTE: Message headers can be configured in any instrument status.

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5. Under Sender Channel, enter the following information:

– Connection Type
– IP Address
– Port Number
6. To save the edits to the HL7 communication settings, tap Save/Test.
To delete the edits to the HL7 communication settings, tap Cancel.
ASTM Communication screen

On the ASTM Communication screen, the operator can view ASTM channel settings.
• Configure the IP address and the port number.
• Configure the character encoding setting.
• Test the ASTM channel settings.
ASTM Communication screen element descriptions, page 232
Configure ASTM communication settings, page 233
ASTM Communication screen element descriptions

The ASTM Communication screen displays a single TCP/IP communication channel to send and
receive messages to and from an ASTM host. The screen is used to open a connection to the
configured port and Internet protocol (IP) address for the ASTM host channel when the following
conditions are met:
• The host interface is configured for ASTM.
• The host connection status is enabled.
ASTM Channel Settings area
IP Address Displays a text box that is used to enter the IP address. The
IP address is configured as four decimal numbers. The range

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for each number is from 0 through 255 and is separated by

periods (supports the IPv4 address).
Character Encoding Displays a drop-down list that provides the following items:
• UTF-8 (default)
• Shift-JIS
• Windows-1252
• ASCII
Function buttons


Configure ASTM communication settings

status
Perform this procedure to configure the ASTM communication settings for the system.
3. On the Computer tab of the Configure screen, tap ASTM Communication.

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4. Under ASTM Channel Settings on the ASTM Communication screen, enter the following
information:
– IP Address
– Port Number
– Character Encoding
5. To save the edits to the ASTM communication settings, tap Save/Test.
To delete the edits to the ASTM communication settings, tap Cancel.
6. To return to the Configure screen tap Done.
LAS Communication screen

On the LAS Communication screen, the operator can view the following information:
• Laboratory automation system (LAS) configuration options
• Sender channel settings
• Receiver channel setting
The system administrator can configure sender channel settings.
LAS Communication screen element descriptions, page 234
Configure LAS communication settings, page 235
LAS Communication screen element descriptions

The LAS Communication screen displays the laboratory automation system (LAS) settings for the
system.
LAS Configuration area
LAS Displays the following options:

• On
• Off (default)

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Sender Channel area
(IP) address. The IP address is configured as four decimal
numbers. The range for each number is from 0 through 255
and is separated by periods (supports the IPv4 address).
Receiver Channel area
Port Number Displays the port number assigned by the system. The port
number is not editable.
Function buttons


Configure LAS communication settings

status
Perform this procedure to configure the laboratory automation system (LAS) communication
settings for the system.
NOTE: To enable or disable LAS configuration, contact an Abbott Laboratories representative.
The LAS sender channel settings must be configured before LAS configuration can be enabled.

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3. On the Computer tab of the Configure screen, tap LAS Communication.
4. Under Sender Channel on the LAS Communication screen, enter the following information:
– IP Address
– Port Number
5. To save the edits to the LAS communication settings, tap Save/Test.
To delete the edits to the LAS communication settings, tap Cancel.
Verify the LAS communication, page 1467
Shortcuts screen
On the Shortcuts screen, the operator can view the following information:
• Configured menu bar shortcut icons
• Available shortcut icon options
The system administrator can configure two shortcuts as icons on the menu bar.
Shortcuts screen element descriptions, page 236
Configure shortcut icons, page 237
Shortcuts screen element descriptions

On the Shortcuts screen, the operator can configure user-defined System menu commands as
icons at the bottom of the menu bar.
Elements
Available Shortcuts Displays a list of available icons that can be configured on the
menu bar.
The following icons are available:

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• Cal/QC inventory
• Procedures (default)
• Configure
• Create Order (default)
• Help (Operations Manual)
NOTE: Only two icons can be configured at one time as

shortcuts. The remaining available System menu commands
can be found in the System menu on the menu bar.
First Shortcut Displays the configured icon and a drop-down list that is used
to select an icon.
Second Shortcut Displays the configured icon and a drop-down list that is used
to select an icon.
Function buttons


Save Saves changes.
Configure shortcut icons
Perform this procedure to change configurable menu bar shortcut icons.

3. On the Computer tab of the Configure screen, tap Shortcuts.

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4. In the First Shortcut drop-down list, tap an icon name.

5. In the Second Shortcut drop-down list, tap an icon name.
6. To save the edits to the shortcuts settings, tap Save.
To delete the edits to the shortcuts settings, tap Cancel.
Automatic Backup screen

On the Automatic Backup screen, the operator can view the automatic backup options.
The system administrator can enable or disable the automatic backup and can configure the
automatic backup options.
Automatic Backup screen element descriptions, page 238
Export Location Option window element descriptions, page 239
Configure an automatic backup, page 240
Automatic Backup screen element descriptions

On the Automatic Backup screen, the operator can enable system automatic backups. When the
Automatically Perform Backup check box is selected, seven daily automatic backups and four
weekly automatic backups are saved on the hard drive.
Automatic Backup Options area
Automatically Perform Displays a check box that is used to select if an automatic

Backup backup is performed daily.
Time of Daily Backup Displays a spin box that is used to enter the time of day for
daily automatic backups to be performed. To enter the system
time, use the system-configured format (HH:MM) and type the
time in the box or tap the Up Arrow and Down Arrow buttons.
If the system is configured for the 12-hour clock format, tap
the AM or PM button to configure the time of day. The default
is 01:00 A.M.
Weekly Backup on Displays a drop-down list that is used to select the day of the
week for daily automatic backups to be saved as the weekly
backup. The default is Sunday.

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Automatic Backup Displays a text box that is used to enter the location for
Location system automatic backups to be copied to removable media.
Browse Displays a button that is used to select the drive and folder
location for the automatic backup.
Function buttons


Save Saves changes.
Export Location Option window element descriptions

In the Export Location Option window, the operator can select the drive and folder location for
the automatic backup.
Elements

selected folder.
Name Displays the name of the drive or folder.
Last Update Displays the date and time that the files in the folder were last
updated.

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Function buttons
OK Saves the selection and closes the window.
Cancel Cancels the operation and closes the window.

Configure an automatic backup
Perform this procedure to configure an automatic backup. Seven daily automatic backups and
four weekly automatic backups are saved on the hard drive and a USB flash drive.
The following items are saved in the backup:
• System calibration data (for example, robotics data and optics data)
• User-defined maintenance procedures
• The system database, which includes the following items:
– System configuration settings (for example, host settings, report settings, system serial
number, and system name)
– Reagent cartridge test counts
– Assay configuration settings
– Assay calibration data
– Control configuration
– Control results
– Specimen results
– Installed maintenance and diagnostic procedures and the maintenance and diagnostic
procedure history
– Supply data
– Assay inserts
– Abbott Mail items
– System updates
NOTE: A USB flash drive must be inserted to create automatic backups.

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3. On the Computer tab of the Configure screen, tap Automatic Backup.
4. Under Automatic Backup Options on the Automatic Backup screen, tap the Automatically
Perform Backup check box to enable the automatic backup.
5. Enter the following information:
– Time of Daily Backup
– Weekly Backup On
– Automatic Backup Location
6. To save the edits to the automatic backup settings, tap Save.
To delete the edits to the automatic backup settings, tap Cancel.
Alinity PRO screen

Alinity PRO is a data-sharing software application between Alinity systems and the Alinity PRO
computer. Alinity PRO provides the following options:
• Inventory sharing allows the laboratory to share reagents, calibrators, and controls between
different instruments that are controlled by a different user interface computer.
• The operational dashboard allows the operator to view a live representation of the current
status of all Alinity systems from one computer. With this information, the operator can
schedule activities that are needed on the instrument.
On the Alinity PRO screen, the operator can view the Alinity PRO settings.
• Enable or disable the inventory-sharing feature.
• Enable or disable status update message transmissions.
• Configure the Internet protocol address and the port number.
Alinity PRO screen element descriptions, page 242
Configure Alinity PRO settings, page 243

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Alinity PRO screen element descriptions

On the Alinity PRO screen, the operator can configure the Alinity PRO settings.
Alinity PRO Settings area
Inventory sharing Displays the following options:

• Enable
• Disable (default)
Status Update Displays the following options:

Message
• Enable
When this option is enabled, messages are sent from the

Alinity system to Alinity PRO to update the operational
dashboard. The operational dashboard allows the operator to
view a live representation of the current status of all Alinity
systems from one computer.
Status Update Interval Displays a text box that is used to enter in seconds how often
the Alinity system sends status information to Alinity PRO. The
status update interval is a range from 15 seconds through
600 seconds. The default is 30 seconds.
(IP) address. The IP address is configured as four decimal
numbers. The range for each number is from 0 through 255
and is separated by periods (supports the IPv4 address).
Function buttons


Save Saves changes.

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Configure Alinity PRO settings

status
Perform this procedure to configure the Alinity PRO settings for the system.
3. On the Computer tab of the Configure screen, tap Alinity PRO.
4. Under Alinity PRO Settings on the Alinity PRO screen, tap Enable or Disable for the
following options:
– Inventory Sharing
– Status Update Messages
5. If Status Update Messages is enabled, enter the following information:
– Status Update Interval
– IP Address
– Port Number
6. To save the edits to the Alinity PRO settings, tap Save.
To delete the edits to the Alinity PRO settings, tap Cancel.
AbbottLink screen
AbbottLink is a data-sharing software application between the laboratory instrumentation and the
Abbott internal systems for the transfer of instrument data, Abbott Mail documentation, and
system updates.
On the AbbottLink screen, the operator can view the AbbottLink settings.

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AbbottLink screen element descriptions, page 244
AbbottLink screen element descriptions

The AbbottLink screen displays the AbbottLink settings.
AbbottLink Service area
Enable Used to enable AbbottLink service. This option is the default.
Disable Used to disable AbbottLink service.
Connection Status Displays the connection status of AbbottLink service.
Instrument Information area
Model Displays the model name of the instrument.
Serial Number Displays the serial number of the instrument.
AbbottLink Host Displays the host name of the instrument.
IP Address Displays the Internet protocol address of the instrument.
Proxy Settings area
Enable Used to enable the proxy settings.
Disable Used to disable the proxy settings. This option is the default.
Auto-Configuration Used to configure the host URL address. When this option is
selected, the URL box is displayed and is blank. The URL box
can contain a maximum of 50 characters.
HTTP and SOCKS
Host Used to enter the host address. When
the HTTP option or the SOCKS option
is selected, the Host box is displayed
and is blank. The Host box can contain
a maximum of 50 characters.

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Port Used to enter the port number. When

the HTTP option or the SOCKS option
is selected, the Port box is displayed
and is blank. The integer value of the
port number can be from 0 through
65535.
Authenticate using the Used to designate that the proxy server

following information requires authentication. When this
check box is selected, the Username
and Password boxes are displayed and
are blank. Each box can contain a
maximum of 50 characters.
Function buttons


Save Saves changes.
AbbottLink screen, page 243
Distance Alert screen

On the Distance Alert screen, the operator can view the distance alert settings and can verify
the distance alert function.
• Enable or disable the distance alert.
• Enable or disable distance alert functionality for exception notifications.
• Enable or disable distance alert functionality for badge notifications.
Distance Alert screen element descriptions, page 246

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Configure distance alert settings, page 248

Verify the distance alert function, page 249
Distance Alert screen element descriptions

On the Distance Alert screen, the operator can enable and disable the distance alert settings.
Distance Alert Options area
Distance Alert Displays the following options:

• Enable
When the distance alert is enabled, it illuminates one of the

following colors:
• Red when a critical message or an alert message is
generated
• Amber when a notification message is generated
Notification Options area

This area is available only if Enable was selected in the Distance Alert area.
Exception Notification Displays the following options:

• Enable
Quality Control (QC) Displays the following options:

Notification
• Enable (default)
• Disable
When this notification option is enabled, the distance alert

illuminates one of the following colors:
• Amber when one or more QC tests completed processing
and generated a Westgard warning
• Red when one or more QC tests completed processing
and are out of range or generated a Westgard failure
Calibration (CAL) Displays the following options:

Notification

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• Disable

• Amber when a calibration is within 1 hour of expiration
• Red when a calibration has expired or failed
Reagents Notification Displays the following options:

• Disable

• Amber when a low alert status is applied to one or more
items in the reagent carousel or when an item in the
reagent carousel or on the reagent and sample manager
(RSM) is within 1 hour of lot or onboard stability
expiration
• Red when a cartridge or rack has a load status error or
when a cartridge or rack with a status other than OK,
Mixing, Low Alert, or Disabled is displayed on the Current
tab of the Reagents screen
Supplies Notification Displays the following options:

• Disable

• Amber when one or more inventory items have exceeded
the configured low alert setting
• Red when an inventory item has a status other than OK,
Overridden, or Low
Procedures Displays the following options:

Notification
• Disable


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• Amber when a maintenance procedure or a diagnostic

procedure that is in process has a status of "Waiting user
response"
• Red when a maintenance procedure is overdue
Function buttons


Save Saves changes.
Test Tests the functionality of the distance alert. When this

function button is selected, the distance alert light is turned
off if the light was illuminated. Then, the light blinks red three
times, blinks yellow three times, and blinks green three times.
When the test is completed, the light remains off.
Configure distance alert settings

status
Perform this procedure to configure the distance alert settings.

3. On the Computer tab of the Configure screen, tap Distance Alert.
4. Under Distance Alert Options on the Distance Alert screen, tap Enable or Disable for the
Distance Alert option.

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5. Under Notification Options, tap Enable or Disable for the following options:
– Exception Notification
– Quality Control (QC) Notification
– Calibration (CAL) Notification
– Reagents Notification
– Supplies Notification
– Procedures Notification
6. To save the edits to the distance alert settings, tap Save.
To delete the edits to the distance alert settings, tap Cancel.
Verify the distance alert function
Prerequisite The distance alert must be enabled.
Perform this procedure to verify the functionality of the distance alert light.
3. On the Computer tab of the Configure screen, tap Distance Alert.
4. On the Distance Alert screen, tap Test.
The distance alert light is turned off if the light was illuminated. Then, the light blinks each
color three times in the following order:
a. Red
b. Yellow
c. Green
When the test is completed, the light remains off.


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Configure screen, Assay tab

The operator can perform the following tasks from the Assay tab of the Configure screen:
Assay Parameters • Configure assay settings.
• Configure calibrator settings.
• Add, delete, or edit SmartWash settings.
• Configure result settings.
• Configure retest rules.
Calibrator Set • Create, edit, or delete a calibrator set.

• Import calibrator data.
Install/Uninstall • Install new or revised assay files.

Assays
• Uninstall assay files.
Import/Export Assays • Import assay files from a USB flash drive.

• Export assay files from a USB flash drive.
Assay Display Order Configure the order in which assays are displayed on screens
and in reports.
Panel Definition Configure assay panels for specimens, controls, or

calibrations.
Cal/QC Ordering • Configure general calibration settings.
• Configure general quality control settings.
Quality Control • Configure multiconstituent and single-constituent controls.

• Import control data.
Westgard Enable or disable Westgard rules for each assay.
Assay Parameters screen, page 251
Calibrator Set screen, page 306
Install/Uninstall Assays screen, page 321
Import/Export Assays screen (c‑series), page 328

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Assay Display Order screen, page 333

Panel Definition screen, page 336
Cal/QC Ordering screen, page 339
Quality Control screen, page 342
Westgard screen, page 365
Assay Parameters screen

On the Assay Parameters screen, the operator can view the following information:
• General settings
• Calibration settings
• Results settings
• Retest rules
• SmartWash (c‑series)

• Edit general assay settings.
• Edit calibration settings.
• Edit result and interpretation information.
• Configure assay retest rules.
• Configure SmartWash settings.
• Create a user-defined assay.
Assay Parameters screen, General tab element descriptions (c‑series potentiometric), page 260
Assay Parameters screen, Calibration tab element descriptions (c‑series photometric), page 266
Assay Parameters screen, Calibration tab element descriptions (c‑series potentiometric), page
272
Assay Parameters screen, Calibration tab element descriptions (i‑series), page 274
Add Result flyout, Edit Result flyout element descriptions, page 281
Retest Assays flyout element descriptions, page 286

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Edit general settings of assay parameters (c‑series photometric), page 286

Edit general settings of assay parameters (c‑series potentiometric), page 289
Edit general settings of assay parameters (i‑series), page 290
Edit general settings of assay parameters (calculated), page 291
Edit calibration settings of assay parameters (c‑series photometric), page 293
Edit calibration settings of assay parameters (c‑series potentiometric), page 294
Edit calibration settings of assay parameters (i‑series), page 296
Configure retest rules, page 299
Change the assay status of a correlation assay, page 301
Create a calculated assay, page 302
Create Assay flyout element descriptions, page 1542
Assay Parameters screen element descriptions

The Assay Parameters screen displays the assays that are installed on the system.
Elements
Installed Assays Identifies the total number of assay parameter files that are
configured on the system.
All tab Displays all assays that are available on the system.
i‑series tab Displays all assays that are available on one or more Alinity i
processing modules.
c‑series tab Displays all assays that are available on one or more Alinity c
processing modules.
Calculated tab Displays all calculated assays.
Function buttons
Configure Navigates to the previous configuration screen.
Select All Selects or deselects all items in a list. The button switches
between Select All and Deselect All.
Print Displays the Print flyout.
Create Navigates to the Create Assay flyout where the operator can

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• Calculated
• Photometric
View/Edit Navigates to the General tab of the Assay Parameters screen

for the selected assay or the first assay that is selected when
multiple assays are chosen.
Assay Parameters screen, General tab element descriptions (c‑series photometric)

On the General tab of the Assay Parameters screen, the operator can view general settings.
Parameters that can be accessed by the system administrator are editable.
All parameters are editable for user-defined assays. For more information, see the assay
applications appendix.
Elements
Assay Name Displays a text box that is used to change the default name of
the assay. The new assay name cannot match an existing
assay name. The assay name can have from 1 through 10
characters.
NOTE: This parameter can be edited when the Assay Status
parameter is not Correlation.
If the correlation version of the assay is entered, CORR is
appended to the assay name and is not included in the 10-
character limit.
Assay Type Displays the assay protocol type. One of the following settings
may be displayed:
• Photometric
• Potentiometric
• Hemolysis
• Icterus
• Lipemia

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• Calculated
Assay Status Displays the assay status defined for the assay. One of the
following settings may be displayed:
• Primary
• Correlation
Date/Time Displays the date and time that an operator installed the
assay or an operator last modified the assay parameters.
Assay Number Displays the number of the assay file. The assay number
must be the same number used for a host computer.
NOTE: If an assay parameter is edited for an assay that
affects result measurement, calculation, or validity checks, an
asterisk is displayed next to the assay number to indicate that
the assay was modified.
Assay Version Displays the version of the assay file.
Result Units Displays the concentration units reported for the assay.
Operator Displays the identification of the operator who installed the

assay or the operator who last modified the assay
parameters.
Assay Availability Displays a drop-down list that is used to select one of the
following settings:
Enabled The assay name is listed on all tabs of

the Create Order screen. (Default)
Disabled The assay name is displayed but is

unavailable on any tab of the Create
Order screen.
Patient Disabled The assay name is included in the

assay list on the Control tab and the
Calibration tab of the Create Order
screen. The assay name is displayed
but is unavailable in the assay list on
the Specimen tab of the Create Order
screen.

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Module Displays one or more check boxes to indicate the processing

modules that are allocated to load the reagent of the assay.
The assay is assigned to all appropriate processing modules.
(Default)
Run Controls for Displays a drop-down list that is used to select which reagent
Onboard Reagents by cartridges to run for quality control:

for each lot loaded on the reagent
carousel.
Cartridge Runs the controls for all cartridges and

carousel.
NOTE: This parameter may only be changed from Lot to

Cartridge for non-user-defined assays.
Reaction Definition area
Reaction Mode Displays the type of reaction that occurs for the assay. The
following settings are available:
• End Up (default)
• End Down
• Rate Up
• Rate Down
Wavelength Displays the primary and secondary wavelengths used to

measure the assay concentration.
Read Times Displays the starting and ending photometric read points that
define the following read times:
Main Displays the read points used for data

reduction.
Flex Displays the read points used for data

reduction when one read or no reads
performed during the main read time
fall within the configured absorbance
range.

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Results that are calculated by using the

absorbance data obtained from the flex
read time are identified with a FLEX
result flag.
NOTE: This parameter is available only
for rate assays.
Color Correction Displays the starting and ending

photometric read points used to adjust
the absorbance range limits based on
the measured sample color.
Absorbance Range Displays the lower and upper absorbance limits for the assay.
All photometric readings need to fall within the absorbance
limits if the limits are defined. Any absorbance value that is
measured at the primary wavelength and falls outside the
absorbance limits during the main or the flex read time is not
used to calculate the result.
Last Read Displays the last photometric read point required for result
calculation. Absorbance data is not collected for photometric
read points that occur after the configured value.
Sample Blank Types Displays the assay blank type. The following settings are
available:
• No Blank
• Self Blank
Blank Read Times Displays the starting and ending photometric read points that
define the blank read time.
NOTE: This parameter is available only when the Sample
Blank Types parameter is Self Blank.
Reagent area
Reagent Displays the reagent name used for the assay.
Diluent Displays the sample diluent name used for the assay.
Diluent Dispense Displays the reagent-pipetting profile the system uses to

Mode aspirate and dispense diluents. The following settings may be
displayed:

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• Type 1 (default)
• Type 2
• Type 6
Reagent Volume Displays the reagent 1 (R1) and reagent 2 (R2) volumes that
are dispensed into the cuvette.
Water Volume Displays the water volume dispensed with an R1 or an R2

concentrated reagent.
Dispense Mode Displays the reagent-pipetting profile the system uses to

aspirate and dispense reagents. The following settings may be
displayed:
• Type 2
• Type 5 (only for R2)
Validity Checks area
Reaction Check Displays the reaction type used to evaluate unexpected

reaction performance. The following settings may be
displayed:
• None
• End Subtraction
• End Ratio
• Rate Subtraction
• Rate Ratio
NOTE: The absorbance values for the reaction check are

measured only at the primary wavelength.
A Read Time, B Read Displays the starting and ending photometric read points for
Time the A Read Time range and B Read Time range used for the
reaction check.
NOTE: This parameter is unavailable when the Reaction
Check parameter is None.
Calculation Limits Displays the lower and upper limits for the acceptable range
of the calculated read time difference (A - B) or the

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calculated read time ratio (A ÷ B). If the calculated value

exceeds the limits, the assay result becomes an exception
and is not processed.
Minimum Displays the minimum acceptable absorbance or absorbance

change during the B Read Time range.
NOTE: This parameter is available only when the Reaction
Check parameter is End Ratio or Rate Ratio.
Maximum Abs Displays the acceptable absorbance variation allowed for

Variation absorbance readings during the main read time. When the
absorbance variation exceeds the defined limit, the assay
result becomes an exception and is not processed.
Mode parameter is End Up or End Down.
Rate Linearity% Displays the allowable percentage change in absorbance. The

validity check is performed during the main read times and
the flex read times by using the first three reads and the last
three reads.
Mode parameter is Rate Up or Rate Down and a minimum of
four photometric read points are defined as the main read
times.
Sample area
All parameters except the Dilution Factor parameter can be edited for non-user-defined assays
but only if the parameters are undefined when the assay is installed.
Dilution Name Displays the assay dilution name. A maximum of three dilution
names can be configured. The dilution name can have from 1
through 10 characters. Additional dilutions may be created
when all available dilutions are not configured.
Sample Displays the sample volume to aspirate from the sample cup
or tube for each configured assay dilution. A value from
1.5 µL through 35 µL in increments of 0.1 µL can be
configured.
Diluted Sample Displays the diluted sample volume to aspirate from the
cuvette for each configured assay dilution. A value from

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1.5 µL through 15 µL in increments of 0.1 µL can be

configured or this parameter can be undefined.
Diluent Displays the sample diluent volume to dispense into the

cuvette for each configured assay dilution. A value from 20 µL
through 345 µL in increments of 1 µL can be configured or
this parameter can be undefined.
Water Displays the water volume to dispense into the cuvette for
each configured assay dilution. A value from 25 µL through
300 µL in increments of 1 µL can be configured or this
parameter can be undefined.
Dilution Factor Displays the sample dilution factor that is calculated by the
system software and is based on the configured sample,
diluent, water, and reagent volumes.
Default Dilution Displays the dilution protocol used as the default for sample
orders. A system administrator can edit this parameter for
non-user-defined assays when more than one dilution name is
configured.
Function buttons


Save Saves changes.
New Reagent Displays the New Reagent flyout for user-defined assays.
View/Edit Reagent Displays the View/Edit Reagent flyout for assays that use
previously configured user-defined reagents.
Linearity flagging (c‑series), page 1581

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Assay Parameters screen, General tab element descriptions (c‑series potentiometric)

Elements
characters.
Assay Type Displays Potentiometric as the assay protocol type.

NOTE: Only photometric and calculated assay protocol types
are available for a user-defined assay.
Assay Status Displays the assay status defined for the assay.

parameters.
following settings:


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Order screen.
screen.

(Default)

carousel.

carousel.
Reagent area
Reagent Displays the reagent name used for the assay.
Function buttons


Save Saves changes.

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Assay Parameters screen, General tab element descriptions (i‑series)

Elements
characters.
NOTE: If the correlation version of the assay is entered,
CORR is appended to the assay name and is not included in
the 10-character limit. The name cannot be edited.
Assay Type Displays the assay protocol type.
Assay Status Displays the assay status defined for the assay. One of the
• Primary
• Correlation

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parameters.
following settings:


Order screen.

screen.

(Default)

carousel.

carousel.
Cal Version Displays the calibration version of the assay file.
Pretreatment options Displays the assay pretreatment protocol type.

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Dilution area
Dilution Name Displays the dilution name. The dilution name must be the
same name used for a host computer.
Low Displays the low concentration range allowed for the dilution.
High Displays the high concentration range allowed for the dilution.
Default Displays an option that is used to identify the dilution protocol

that is used as the default for assay processing.
Assay Specific Settings area

Assay-specific settings are used in assay formulas for some Alinity i assays. Assay-specific
settings are not available for all assays and are displayed only when the settings are used.
Name Displays the assay-specific setting name.
Current Value Displays a text box that is used to enter the assay-specific
setting value.
Range Displays the editable range allowed for the assay-specific

setting.
Function buttons


Save Saves changes.

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Assay Parameters screen, General tab element descriptions (calculated)

On the General tab of the Assay Parameters screen, the operator can change general assay
settings for calculated assays.
Elements
Assay Name Displays a text box that is used to change the name of the
calculated assay. The new assay name cannot match an
existing assay name. The assay name can have from 1
through 10 characters.
Assay Type Displays Calculated as the assay protocol type.
Date/Time Displays the date and time that an operator created or

installed the assay or an operator last modified the assay
parameters.
affects result measurement or calculation, an asterisk is
displayed next to the assay number to indicate that the assay
was modified.
Operator Displays the identification of the operator who created or

installed the assay or the operator who last modified the
assay parameters.
following settings:


Order screen.
Calculated Formula Displays the calculated formula that is created by using the
numeric keypad. The calculated formula can have from 1
NOTE: The numeric keypad cannot be displayed for assays
that have assay numbers from 3000 through 3999. The

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calculated formula is created automatically during assay

installation and cannot be edited.
Lower Range Displays a text box that is used to enter the lower limit of the
assay range.
Upper Range Displays a text box that is used to enter the upper limit of the
assay range.
Selected Assay Displays the name of the selected assay that is used in the
calculated formula.
Minimum Displays the minimum result range for the selected assay.
Maximum Displays the maximum result range for the selected assay.
Function buttons


Save Saves changes.
Select Assays Displays the Select Assays flyout.

photometric)
On the Calibration tab of the Assay Parameters screen, the operator can view calibration
settings. Parameters that can be accessed by the system administrator are editable.
All parameters except those parameters configured on the General tab are editable for user-
defined assays. For more information, see the assay applications appendix.

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Elements
Assay Name Displays the assay name.
Assay Number Displays the number of the assay file.


parameters.
Calibration area
Calibration Method Displays one of the following calibration methods:

• Absorbance
• Factor
• Linear (default)
• Logit-4
• Spline
• Use Cal Factor Blank
Full Calibration Displays a text box that is used to change the amount of time
Interval in hours that the full calibration curve is valid after a full
calibration is completed. The value cannot be edited to a
value greater than the number of hours specified in the
released assay file.

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Factor Displays the calibration factor when the Calibration Method

parameter is Factor.
Default Ordering Type Displays the default calibration type used to create calibration
orders for the assay. The following settings may displayed:
• Full
• Adjust
NOTE: This parameter is unavailable when the Adjust Type

parameter is None.
Use Cal Factor From Displays the assay to reference for calibration information
used in result calculation. Configured c‑series photometric
assays are used to configure this parameter.
NOTE: This parameter is displayed only when the Calibration
Method parameter is Use Cal Factor Blank.
Adjust Type Displays a drop-down list that is used to select the type of
adjust calibration performed for the assay:
• None (default)
• Blank
• 1-Point
• 2-Point
NOTE: This parameter is available only when the Calibration

Method parameter is Linear, Spline, or Logit-4.
Adjust Interval Displays a text box that is used to enter the amount of time in
hours that the adjust calibration is valid after an adjustment
calibration is completed. A value from 0 through 9999 can be
configured.
parameter is None.
If 0 is configured, the adjust calibration interval is not tracked.
Adjust Level Displays a drop-down list that is used to select the calibrator
level to use for the 1-Point and 2-Point adjust calibration
types. The configured levels for the calibrator set are used to
configure this parameter.
parameter is None or Blank or when the Calibration Method
parameter is Absorbance, Factor, or Use Cal Factor Blank.

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Calibrators area
Calibrator Set Displays the calibrator set name.

For c‑series assays that use a blank calibrator set, the
calibrator set name is displayed first, followed by the blank
calibrator set name. The blank calibrator set is available only
for non-user-defined assays.
NOTE: This parameter is not displayed when the Calibration
Method parameter is Absorbance or Use Cal Factor Blank.
Replicates Displays a text box that is used to change the number of

replicates to run for the blank and each configured calibrator
level for assay calibration. A value from 1 through 3 can be
configured.
Calibrator Level Displays the name of the blank and displays a maximum of six
calibrator levels used as points in the calibration.
NOTE: This parameter is not displayed when the Calibration
Sample Displays the sample volume dispensed into the cuvette for the
blank and for each configured calibrator level.
Diluted Sample Displays the diluted sample volume for the blank and for each
configured calibrator level. The diluted sample volume is
aspirated from the cuvette for dilution during calibration if a
dilution protocol is defined for the calibrator.
Diluent Displays the diluent volume for the blank and for each
configured calibrator level. The diluent volume is dispensed
into the cuvette for dilution during calibration if a dilution
protocol is defined for the calibrator.
Water Displays the water volume used to dilute a concentrated

diluent for the blank and for each configured calibrator level.
The water volume is dispensed with any aspirated diluent into
the cuvette for dilution during calibration if a dilution protocol
is defined for the calibrator.

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Blank Absorbance Displays boxes that are used to enter the lower and upper
Range limits that define an acceptable blank absorbance value
measured during calibration:
Lower limit A value from -9.9999 through 9.9998

can be configured or this parameter
can be undefined.
Upper limit A value from -9.9998 through 9.9999

can be undefined.
NOTE: If this parameter is undefined, the check is not

performed.
Span Displays a drop-down list that is used to select the calibrator

level used as the upper limit of the calibration span that is
evaluated for the Span Absorbance Range check. This
parameter can be configured as one of the calibrator levels
defined for the assay or can be undefined.
NOTE: The blank defines the lower limit of the calibration
span.
This parameter is available only when the Calibration Method
parameter is Linear, Spline, or Logit-4.
Span Absorbance Displays text boxes that are used to enter the lower and upper
Range limits that define an acceptable absolute absorbance
difference between the blank and the defined calibrator level
during calibration:
Lower limit A value from 0.0001 through 9.9998

can be undefined.
Upper limit A value from 0.0002 through 9.9999

can be undefined.

performed. Both limits must be defined to perform the check.

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Expected Cal Factor Displays a text box that is used to enter the target value for
the calibration factor (1/slope) when the calibration is
calculated. A value from -999999.99 through 9999999.99 can
be configured.
Method parameter is Linear or Spline. For assays that use a
linear calibration method, all segments of the calibration curve
are evaluated. For assays that use a spline calibration
method, only the first segment of the calibration curve is
evaluated.
If this parameter is undefined, the check is not performed.
Expected Cal Factor Displays a text box that is used to enter the percent tolerance
Tolerance % of the calibration factor that is expected when the calibration
is calculated. This parameter is used with the Expected Cal
Factor parameter to determine an acceptable range for the
calibration factor. A value from 1 through 99 can be
evaluated.
Maximum Curve Fit Displays a text box that is used to enter the parameter for
maximum curve fit. This parameter specifies the maximum
limit of the sum of the absolute values of the difference
between the approximated absorbance of the calculated
calibration and the measured absorbance. A value from
0.0001 through 9.9999 can be configured or this parameter
can be undefined.
Method parameter is Logit-4.
Function buttons


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Save Saves changes.
New Cal Set Displays the New Cal Set flyout for user-defined assays.

potentiometric)
Elements


parameters.

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Calibration area
Full Calibration Displays a text box that is used to change the amount of time
Interval in hours that the full calibration curve is valid after a full
configured.
NOTE: The interval cannot exceed the limit provided in the
assay parameter file.
If 0 is configured, the full calibration interval is not tracked.
Slope Limit (%) Displays text boxes that are used to enter the lower and upper
limits that define an acceptable slope value for ICT assay
calibrations:
Lower limit A value from 45 through 119 can be

configured.
Upper limit A value from 46 through 120 can be

configured.
Calibrator Low Displays the name of the low calibrator.
Low Concentration Displays the concentration value of the low calibrator.
Calibrator High Displays the name of the high calibrator.
High Concentration Displays the concentration value of the high calibrator.

replicates to run for the Low, High, and Index calibrator levels
for assay calibration. A value from 1 through 3 can be
configured.
Index Options area
Index Used Displays options that define whether the optional index
solution is measured during ICT calibration and is used to
adjust all ICT results for the assay:
• Yes
• No (default)

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NOTE: If Yes is selected, all Index Options parameters must

be defined.
Index Concentration Displays a text box that is used to enter the concentration of
the index solution. A value from 0 through 9999999 can be
configured.
Index Range Displays text boxes that are used to enter the lower and upper
limits that define the acceptable range for the index
concentration calculated during ICT assay calibration. Values
from 0 through 9999999.9999 can be configured.
NOTE: The lower limit value must be less than the upper limit
value.
Function buttons


Save Saves changes.
Assay Parameters screen, Calibration tab element descriptions (i‑series)

Elements

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parameters.
Calibration area
Calibration Method Displays the data reduction method used in the calibration
math model.
Calibration Type Displays one of the following calibration types:

• Adjust
• Full
• Index
Adjustment Method Displays the type of adjustment used in an adjustment

calibration. An adjustment method is displayed only when the
Calibration Type parameter is Adjust.
Calibration Interval Displays a text box that is used to change the amount of time
in hours that the calibration curve is valid. A value from 0
through 9999 can be configured. If 0 is configured, the
calibration interval is not tracked.
NOTE: If an assay file contains a default calibration interval
other than 0, the calibration interval can be decreased to 1
but cannot be increased.

calibrator replicates used in the calculation of the calibration.

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Reference Assay Displays the reference calibration assay number that is used
to generate results. A reference assay number is displayed
only when the Calibration Method parameter is Reference.
Calibrator Concentrations area
Cal A through Cal F Displays the concentrations of the six calibrators used as
points for a Full calibration type or displays the concentrations
for the master reference curve for an Adjust calibration type.
Calibrator concentrations are not displayed for an Index
calibration type.
Adjust Displays the concentrations for the Cal 1 and Cal 2 adjusters.
Adjust concentrations are displayed only when the Calibration
Type parameter is Adjust.
Function buttons


Save Saves changes.
Assay Parameters screen, Results tab element descriptions

On the Results tab of the Assay Parameters screen, the operator can view and edit result and
interpretation settings.
Elements

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NOTE: This element is not displayed for calculated assays.



parameters.
Result Units area
Result Units Displays a drop-down list that is used to select a result unit.
NOTE: For calculated assays, a text box is displayed that is
used to enter a unit name. The unit name can have from 0
Decimal Places Displays a drop-down list that is used to select the number of
decimal places to display for an assay result.
Result Unit UCUM Displays the Unified Code for Units of Measure (UCUM). The
UCUM is a system of codes that represents the measurement
units that are contemporarily used in international science,
engineering, and business. The UCUM can be used by host
computers.
NOTE: For calculated assays, a text box is displayed that is
used to enter a UCUM result unit. The UCUM result unit can
have from 0 through 20 characters.

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Correlation Factor Displays a text box that is used to enter a factor for c‑series
assays if results require a calculation to match another
system.
NOTE: This element is available only for c‑series
noncalculated assays.
When values are configured for the Correlation Factor and
Intercept parameters, the system calculates the results by
using the following equations:
Samples with no (Original result x Correlation factor) +

dilution factor applied Intercept
Samples with either a [(Original result x Correlation factor) +

manual or an Intercept] x Dilution factor
automated dilution
factor applied
Intercept Displays a text box that is used to enter an intercept for

c‑series assays if results require a calculation to match
another system.
NOTE: This element is available only for c‑series
noncalculated assays.


automated dilution
factor applied
Results area
Low Linearity Displays a text box that is used to enter the low limit value of
the configured measurement range.
NOTE: For i‑series assays, this value can be edited only when
the default dilution is the first dilution.
For c‑series photometric assays, the system adjusts the
configured linearity value by the sample dilution factor.

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Linearity values are adjusted by the sample dilution factor in

each of the following instances:
• When a user-defined assay is created that uses a
standard sample dilution factor other than 1.00
• When linearity values are edited for a non-user-defined
assay that uses a sample dilution factor other than 1.00
High Linearity Displays a text box that is used to enter the high limit value of
the configured measurement range.
NOTE: For i‑series assays, this value can be edited only when
the default dilution is the first dilution. This value cannot be
edited to exceed the default high-linearity value of the assay.
For c‑series photometric assays, the system adjusts the
configured linearity value by the sample dilution factor.
Linearity values are adjusted by the sample dilution factor in
each of the following instances:
• When a user-defined assay is created that uses a
standard sample dilution factor other than 1.00
• When linearity values are edited for a non-user-defined
assay that uses a standard sample dilution factor other
than 1.00
Gender Displays the gender for configured result flags. Result flags
are evaluated based on the sample data that was configured
in the Patient Details flyout. The following settings may be
displayed:
• Male
• Female
• Either
NOTE: This range may be used with any gender setting
(male, female, and unknown).
Age Unit Displays the age unit for the configured age range. The
• Days
• Months
• Years

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Age Range Displays the age range for configured result flags. The
• 0 - 365 (Days)
• 0 - 24 (Months)
• 0 - 130 (Years)
Normal Range Displays the normal range for the configured gender and age
range.
Extreme Range Displays the extreme range for the configured gender and age
range.
NOTE: Assay results are evaluated against the configured ranges in the order in which they are
displayed.
Interpretation area
Interpretation settings are displayed if result interpretations are configured in the assay file.
Name Displays a drop-down list that is used to select the

interpretation name. Names in the drop-down list are assay
specific.
The following c‑series assay and calculated assay names are
available for assays that do not have configured result
interpretations in the assay file:
• <UserDefined>: Customized text can be configured.
• <NotDefined>: No interpretation is provided.
• <Blank>: A range can be configured without interpretation
text.
NOTE: Interpretation settings must be configured beginning

with the first row. Rows cannot be skipped and the Name text
box cannot be empty. To configure a range without
interpretation text, <Blank> must be selected.
Range Displays a text box that is used to enter the range for the
interpretation. If a text box is not displayed, the range is not
editable.
Review Required Displays a check box that is used to select which results are
held until they are reviewed and released manually.

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NOTE: Results are held if the Hold option was configured for
result release mode options and the results fall within the
specified interpretation range.
Function buttons

Add Result Displays the Add Result flyout.

Save Saves changes.
Edit Result Displays the Edit Result flyout.
Delete Result Displays a message requesting confirmation to delete the

selected result flag range.
Add Result flyout, Edit Result flyout element descriptions

In the Add Result flyout, the operator can add results. In the Edit Result flyout, the operator can
edit results.
Elements
Gender Displays a drop-down list that is used to select the gender for
the result flag:
• Either
• Male
• Female

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Age Unit Displays a drop-down list that is used to select the age unit
for the defined age range:
• Years
• Months
• Days
Age Range Displays text boxes that are used to enter the Minimum age
range and the Maximum age range.
Normal Range Displays text boxes that are used to enter the Minimum
normal range and the Maximum normal range for the defined
gender and age range.
Extreme Range Displays text boxes that are used to enter the Minimum
extreme range and the Maximum extreme range for the
defined gender and age range.
Function buttons



page 1564
Assay parameters (c‑series photometric, user defined), page 1540
Assay Parameters screen, Retest Rules tab element descriptions

On the Retest Rules tab of the Assay Parameters screen, the operator can configure or edit
retest rules.
Elements

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Result Units Displays the concentration units reported for the assays.

parameters.
Assay Retest Rules area
Assay Retest Rules Displays a list of configured retest rules.

NOTE: The retest rules are displayed in the chronological
order in which the rules are created. The system runs the first
rule that meets the defined criteria.
Retest Rule Name Displays a text box that is used to change the retest rule
name. The retest rule name can have from 1 through 18
characters.
Result Indicator Displays the following options:
Result Range Retest criteria based on result ranges.
Interpretation Retest criteria based on interpretations.

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Exception Retest criteria based on exceptions.

The assay is retested if one of the
following message codes is generated:
• 1037 Unable to calculate result.
Rate reaction linearity failure.
Insufficient absorbance reads
within absorbance range.
Absorbance exceeded optical
limits.
• 1040 Unable to calculate result. No
absorbance reads within
absorbance range.
Reaction check failure.
ICT reference solution voltage drift
error.
Final RLU read is outside the
specification of the highest
calibrator.
Final RLU read is outside the
specification of the lowest
calibrator.
• 1402 Unable to process test.
Activated read failure.
• 1403 Unable to process test. Final
read failure.
Result Range Displays text boxes that are used to

enter the result range.
NOTE: The Result Range element is
displayed if the Result Range option is
selected as the result indicator.
Interpretation Displays a drop-down list that is used to

select the interpretation.

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NOTE: The Interpretation element is

displayed if the Interpretation option is
selected as the result indicator.
Original Dilution Displays a drop-down list that is used to select the dilution for
the original test. The original test must be run at this dilution
to be considered for retesting.
NOTE: This element is unavailable for calculated assays.
Selected Retest Displays the retest assay name. Any number of assays can be
Assays defined.
Retest Dilution Displays a drop-down list that is used to select the retest
dilution for the specific retest assay.
Replicates Displays a drop-down list that is used to select the number of

replicates for the specific retest assay and dilution.
Function buttons


Save Saves the added rules.
Add Rule Adds the rule to the Assay Retest Rules list and clears the
screen to accept a new rule.
Delete Rule Displays a message requesting confirmation to delete the

selected rule.
Retest Assays Displays the Retest Assays flyout.

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Retest Assays flyout element descriptions

In the Retest Assays flyout, the operator can select one or more retest assays.
Element
Select Retest Assays Displays the options that are available to select assays for
retesting. The following options are available to filter the list of
assays:
All option Displays all assays that are available

for retesting on the system.
i‑series option Displays all assays that are available

for retesting on one or more Alinity i
processing modules.
c‑series option Displays all assays that are available

for retesting on one or more Alinity c
processing modules.
Calculated option Displays all calculated assays that are

available for retesting on the system.
Function buttons



Edit general settings of assay parameters (c‑series photometric)

status

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Perform this procedure to edit the following general settings of assay parameters for a c‑series
photometric assay:
• Assay name
• Assay availability
• Module allocation
• The option to run controls by lot or cartridge
• Default dilution
• The option to add a dilution protocol
NOTE: A user-defined dilution protocol can be created only for assays with fewer than three
configured dilution protocols.
The user-defined dilution protocol is retained except when an additional dilution protocol is
included with an assay file revision in the same position as the user-defined dilution
protocol.
NOTE: All general settings of a user-defined photometric assay can be edited. If the following
general settings are edited, calibration data for the assay is deleted:
• Reaction mode
• Primary wavelength
• Secondary wavelength
• Main read times
• Blank read times
• Reagent name
• Reagent volume
• Water volume
• Reagent dispense mode
The assay parameters of assays with pending orders cannot be edited.

2. On the Configure screen, tap the Assay tab.
3. On the Assay tab of the Configure screen, tap Assay Parameters.
4. On the Assay Parameters screen, tap one or more assays to edit.
NOTE: To filter the list of assays, tap the c-series tab.
5. Tap View/Edit.

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6. In the Assay Name text box on the General tab of the Assay Parameters screen, edit the
default name of the assay if necessary.
NOTE: The assay name can contain a maximum of 10 alphanumeric characters.
The assay name cannot be edited for an assay that has an assay status of Correlation.
7. In the Assay Availability drop-down list, tap an item.
NOTE: For c‑series assays that use a blank calibrator set, both the calibrator set and the
blank calibrator set must be configured fully to enable the assay.
8. In the Module area, tap the module number check boxes for the modules that are allocated
to load the reagent of the assay.
NOTE: This parameter is available only if the Alinity ci‑series is configured with more than
one processing module of the same type.
9. In the Run Controls for Onboard Reagents by drop-down list, tap an item.
10. Under Sample, tap an option in the Default Dilution area if more than one option is
available.
11. Under Sample, enter the following information as necessary to create a new dilution
protocol:
– Dilution Name
NOTE: The dilution name can contain a maximum of 10 alphanumeric characters.
– Sample (volume)
– Diluted Sample (volume)
– Diluent (volume)
– Water (volume)
NOTE: The operator has a responsibility to confirm the performance of the configured
dilution protocol.
12. To save the edits to the assay parameter settings, tap Save.
To delete the edits to the assay parameter settings, tap Cancel.
13. If more than one assay was selected, at the right side of the Assay Parameters screen, tap
the next assay to configure, and then repeat steps 6, page 288 through 12, page 288.
14. To return to the Assay Parameters screen, tap Done.
15. To return to the Configure screen, tap Configure.

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Edit general settings of assay parameters (c‑series potentiometric)

status
Perform this procedure to edit the following general settings of assay parameters for a c‑series
potentiometric assay:
• Assay name
NOTE: The assay parameters of assays with pending orders cannot be edited.
5. Tap View/Edit.

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Edit general settings of assay parameters (i‑series)

status
Perform this procedure to edit the following general settings of assay parameters for an i‑series
assay:
• Assay name
• Default dilution
NOTE: To filter the list of assays, tap the i-series tab.
5. Tap View/Edit.

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10. Under Dilution, tap an option in the Default Dilution area if more than one option is
available.
Edit general settings of assay parameters (calculated)

status
Perform this procedure to edit an assay that uses a mathematical formula to derive a calculated
result.
NOTE: To filter the list of assays, tap the Calculated tab.
5. Tap View/Edit.
default name of the calculated assay.
8. Tap Select Assays.
NOTE: The Select Assays button is unavailable for non-user-defined calculated assays that
have assay numbers from 3000 through 3999.
9. In the Select Assays flyout, tap the constituent assays that are used in the new calculated
formula.

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For example, to create an LDL calculation, tap Chol, tap Ultra HDL, and then tap Trig.
NOTE: Assays are assigned to the calculator buttons in the order in which the assays are
selected.
10. To save the assay selection, tap Done.
To delete the assay selection, tap Cancel.
11. For each assay under Selected Assay, perform one of the following steps to enter a result
range:
– To define a specific result range, type a value in the Minimum text box and type a
value in the Maximum text box.
– To define a range where the results are less than or equal to a specific value, leave the
Minimum text box blank and type a value in the Maximum text box.
– To define a range where the results are greater than or equal to a specific value, type a
value in the Minimum text box and leave the Maximum text box blank.
NOTE: If the selected assay test result falls outside the defined result range, the calculated
test result becomes an exception and the result is not reported.
12. To delete the existing calculated formula, tap the Backspace key.
NOTE: The formulas cannot be edited for non-user-defined calculated assays that have
assay numbers from 3000 through 3999.
13. To enter a new calculated formula, tap one or more constituent assays, which are indicated
by the ASSAY1, ASSAY2, ASSAY3, and ASSAY4 buttons on the calculator, and then tap
the appropriate calculator function buttons.
The formula is displayed as it is entered in the Calculated Formula text box.
For example, to enter the formula for an LDL calculation [Cholesterol - HDL - (Triglyceride ÷
5)], perform the following steps:
a. On the calculator, tap ASSAY1 (Cholesterol), and then tap the Minus Sign button.
b. Tap ASSAY2 (HDL), and then tap the Minus Sign button.
c. Tap the Opening Parenthesis button, and then tap ASSAY3 (Triglyceride).
d. Tap the Slash Mark (divide) button, tap 5, and then tap the Closing Parenthesis
button.

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Edit calibration settings of assay parameters (c‑series photometric)

status
Perform this procedure to edit the following calibration settings of assay parameters for a
c‑series photometric assay:
• Full calibration interval
• Adjust calibration type
• Adjust calibration interval
• Replicates
• Validity checks
All calibration settings of a user-defined photometric assay can be edited. If the following
calibration settings are edited, calibration data for the assay is deleted:
• Calibration mode
• Calibrator volume specifications:
– Sample volume
– Diluted sample volume
– Diluent volume
– Water volume

5. Tap View/Edit.
6. On the Assay Parameters screen, tap the Calibration tab.
7. Under Calibration on the Calibration tab of the Assay Parameters screen, enter the
following information:
– Full Calibration Interval (Hours)

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NOTE: If an assay file contains a default calibration interval other than zero, the
calibration interval can be decreased but cannot be increased. This parameter is
unavailable for assays when the absorbance data reduction method and the use cal
factor blank calibration method are used.
– Adjust Type
NOTE: This parameter is unavailable for assays when the factor data reduction method
and the use cal factor blank calibration method are used.
– Adjust Interval
– Default Ordering Type
NOTE: This parameter is available only if the Adjust Type parameter is configured with
a setting other than None.
8. Under Calibrators, type the number of replicates in the Replicates text box.
9. Under Validity Checks, enter the following information:
– Blank Absorbance Range
– Span
– Span Absorbance Range
– Expected Cal Factor
– Expected Cal Factor Tolerance %
Edit calibration settings of assay parameters (c‑series potentiometric)

status
Perform this procedure to edit the following calibration settings of assay parameters for a
potentiometric assay:
• Full calibration interval
• Replicates

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• Slope limit (%)

• Index options
5. Tap View/Edit.
– Full Calibration Interval (Hours)
NOTE: If an assay file contains a default calibration interval other than zero, the
calibration interval can be decreased but cannot be increased.
– Replicates
– Slope Limit (%)
8. Under Index Options, enter the following information:
– Index Used
– Index Concentration
– Index Range

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Edit calibration settings of assay parameters (i‑series)

status
Perform this procedure to configure the calibrator replicates and the calibration interval.
NOTE: To filter the list of assays, tap the i-series tab.
5. Tap View/Edit.
– Calibration Interval (Hours)
NOTE: If an assay file contains a default calibration interval other than 0, the calibration
interval can be decreased to 1 but cannot be increased.
If 0 is configured, the calibration interval is not tracked.
– Replicates

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Edit result settings of assay parameters

status
Perform this procedure to configure the results settings of assay parameters for an assay.
NOTE: To filter the list of assays, tap the tab for i-series, c-series, or Calculated.
5. Tap View/Edit.
6. On the Assay Parameters screen, tap the Results tab.
7. Under Result Units on the Results tab of the Assay Parameters screen, enter the following
information:
– Result Units
NOTE: For non-user-defined assays, tap a unit setting in the drop-down list if more than
one setting is available.
For user-defined assays or calculated assays, type the unit name.
– Decimal Places
– Result Unit UCUM
NOTE: This parameter can be edited only for user-defined assays or calculated assays.
– Correlation Factor
NOTE: This parameter is available only for c‑series.
– Intercept
NOTE: This parameter is available only for c‑series.
8. If the Result Units parameter is edited, tap Save to update the displayed result values to
the new unit.
9. Under Results, enter the following information:
– Low Linearity

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NOTE: For i‑series assays, this parameter can be edited only when the default dilution
is the first dilution.
– High Linearity
is the first dilution. The value cannot be edited to exceed the high-linearity default of
the assay.
NOTE: If a c‑series assay has a standard dilution factor that is not 1.00, ensure that the
entered values for low linearity and high linearity are adjusted by the standard dilution
factor.
10. To add a new result range, perform the following steps:
a. Tap Add Result.
b. In the Add Result flyout, enter the following information:
• Gender
• Age Unit
• Age Range
• Normal Range
• Extreme Range
NOTE: An extreme range is not required.
c. To save the edits to the result settings, tap Done.
To delete the edits to the result settings, tap Cancel.
11. To edit a result range, perform the following steps:
a. In the Results list, tap a result range.
b. Tap Edit Result.
c. In the Edit Result flyout, edit any of the following information:
• Gender
• Age Unit
• Age Range
• Normal Range
• Extreme Range
d. To save the edits to the result settings, tap Done.
12. To delete a result range, perform the following steps:
a. In the Results list, tap a result range.
b. Tap Delete Result.

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c. When a confirmation message is displayed, tap Yes.

13. Under Interpretation, tap an interpretation in the Name drop-down list.
NOTE: If <UserDefined> is selected, type the name of the interpretation in the Name text
box.
14. In the Range text box, type an interpretation range value.
NOTE: Not all interpretation names and ranges are editable.
15. For the appropriate interpretation, tap Review Required.
NOTE: If the Review Required check box is selected, the results are held for manual
release when the Hold option is configured for the Result Release Mode and the results are
within the specific interpretation range.
16. For each available interpretation, repeat steps 13, page 299 through 15, page 299.
17. Tap Save.
19. To return to the assay list on the Assay Parameters screen, tap Done.
page 1564
Configure retest rules

status
Perform this procedure to configure one or more retest rules with criteria based on result
concentration ranges, interpretations, or exceptions.
NOTE: The retest rules must be defined in order since the system runs the first rule that meets
the defined criteria.

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4. On the Assay Parameters screen, tap one or more assays to configure.
NOTE: To filter the list of assays, tap the tab for i-series, c-series, or Calculated.
5. Tap View/Edit.
6. On the Assay Parameters screen, tap the Retest Rules tab.
7. Under Assay Retest Rules on the Retest Rules tab of the Assay Parameter screen, type
the name in the Retest Rule Name text box.
NOTE: Under Assay Retest Rules, if a retest rule is selected, tap the selected rule to
cancel the selection.
8. If the criteria is based on result ranges, perform the following steps:
a. In the Result Indicator area, tap the Result Range option.
b. To enter a result range, perform one of the following steps:
• To retest all samples automatically when the original results are within a specific
range, type values in both result range text boxes.
• To retest all samples automatically when the original results are less than or equal
to a specific value, leave the first result range text box blank and type a value in
the second result range text box.
• To retest all samples automatically when the original results are greater than or
equal to a specific value, type a value in the first result range text box and leave
the second result range text box blank.
9. If the criteria is based on interpretations, perform the following steps:
a. In the Result Indicator area, tap the Interpretation option.
b. In the Interpretation drop-down list, tap an interpretation.
10. If the criteria is based on exceptions, tap the Exception option in the Result Indicator area.
NOTE: The assay is retested if one of the following message codes is generated:
– 1037 Unable to calculate result. Rate reaction linearity failure.
– 1038 Unable to calculate result. Insufficient absorbance reads within absorbance range.
– 1039 Unable to calculate result. Absorbance exceeded optical limits.
– 1040 Unable to calculate result. No absorbance reads within absorbance range.
– 1041 Unable to calculate result. Reaction check failure.
– 1042 Unable to calculate result. ICT reference solution voltage drift error.
– 1043 Unable to calculate result. Final RLU read is outside the specification of the
highest calibrator.
lowest calibrator.
– 1402 Unable to process test. Activated read failure.

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– 1403 Unable to process test. Final read failure.

11. In the Original Dilution drop-down list, tap an original dilution.
NOTE: Ensure that the values entered in step 8.b, page 300 are adjusted by the original
dilution factor.
12. Tap Retest Assays.
13. In the Retest Assays flyout, tap one or more retest assays.
NOTE: To filter the list of available assays, tap the option for i-series, c-series, or
Calculated. Correlation assays are unavailable for selection.
14. To save the retest assay selection, tap Done.
To delete the retest assay selection, tap Cancel.
15. Under Retest Dilution, tap a retest dilution in the Retest Dilution drop-down list for each
assay.
16. Under Replicates, tap the number of replicates in the Replicates drop-down list for each
assay.
17. To add the retest rule, tap Add Rule.
18. To add additional retest assays, repeat steps 12, page 301 through 17, page 301.
19. To save the edits to the rule settings, tap Save.
To delete the edits to the rule settings, tap Cancel.
Change the assay status of a correlation assay
Prerequisite Complete all remaining orders for the correlation and primary
assay versions.

status
Perform this procedure to convert a correlation assay to a primary assay after correlation studies
have been completed.

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When a correlation assay is converted to a primary assay, the system software performs the
following functions:
• The assay status of the correlation assay is changed from Correlation to Primary.
• The old version of the assay file is uninstalled and cannot be reinstalled.
• Specimen results, quality control results, and calibration information for both the correlation
assay and the primary assay are saved.
• The calibration status for the primary assay is Inactive.
• The calibration status for the correlation assay is maintained.

4. On the Assay Parameters screen, tap one or more correlation assays to convert.
NOTE: To filter the list of assays, tap the i-series tab or the c-series tab.
5. Tap View/Edit.
6. In the Assay Status drop-down list on the General tab of the Assay Parameters screen, tap
Primary.
7. To save the edits to the assay status settings, tap Save.
To delete the edits to the assay status settings, tap Cancel.
Create a calculated assay

status
Perform this procedure to create an assay that uses a mathematical formula to derive a
calculated result.

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4. On the Assay Parameters screen, tap Create.
5. In the Create Assay flyout where the Calculated option is selected, tap Done.
6. On the General tab of the Assay Parameters screen, type the name of the calculated assay
in the Assay Name text box.
7. In the Assay Number text box, if an assay number other than the number that is displayed is
needed, type a number from 2000 through 2999.
NOTE: A non-user-defined calculated assay has an assay number from 3000 through 3999
that cannot be edited.
8. In the Assay Availability drop-down list, tap an assay availability item.
9. Tap Select Assays.
10. In the Select Assays flyout, tap the constituent assays that are used in the calculated
formula.
For example, to create an LDL calculation, tap Chol, tap Ultra HDL, and then tap Trig.
NOTE: Assays are assigned to the calculator buttons in the order in which the assays are
selected.
11. To save the assay selection, tap Done.
To delete the assay selection, tap Cancel.
12. To enter a calculated formula, tap one or more constituent assays, which are indicated by
the ASSAY1, ASSAY2, ASSAY3, and ASSAY4 buttons on the calculator, and then tap the
appropriate calculator function buttons.
The formula is displayed as it is entered in the Calculated Formula text box.
For example, to enter the formula for an LDL calculation [Cholesterol - HDL - (Triglyceride ÷
5)], perform the following steps:
a. On the calculator, tap ASSAY1 (Cholesterol), and then tap the Minus Sign button.
b. Tap ASSAY2 (HDL), and then tap the Minus Sign button.
c. Tap the Opening Parenthesis button, and then tap ASSAY3 (Triglyceride).
d. Tap the Slash Mark (divide) button, tap 5, and then tap the Closing Parenthesis
button.
13. For each assay under Selected Assay, perform one of the following steps to enter a result
range:
– To define a specific result range, type a value in the Minimum text box and type a
value in the Maximum text box.
– To define a range where the results are less than or equal to a specific value, leave the
Minimum text box blank and type a value in the Maximum text box.

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– To define a range where the results are greater than or equal to a specific value, type a
value in the Minimum text box and leave the Maximum text box blank.
NOTE: If the selected assay test result falls outside the defined result range, the calculated
test result becomes an exception and the result is not reported.
14. To save the edits to the calculated assay settings, tap Save.
To delete the edits to the calculated assay settings, tap Cancel.
15. Tap the Results tab.
16. Under Result Units on the Results tab of the Assay Parameters screen, enter the following
information:
– Result Units
– Decimal Places
– Result Unit UCUM
17. If the Result Units parameter is edited, tap Save to update the displayed result values to
the new unit.
18. Under Results, enter the following information:
– Low Linearity
is the first dilution.
– High Linearity
is the first dilution. The value cannot be edited to exceed the high-linearity default of
the assay.
19. To add a new result range, perform the following steps:
a. Tap Add Result.
b. In the Add Result flyout, enter the following information:
• Gender
• Age Unit
• Age Range
• Normal Range
• Extreme Range
c. To save the edits to the result settings, tap Done.
20. Under Interpretation, tap an interpretation in the Name drop-down list.

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NOTE: If <UserDefined> is selected, type the name of the interpretation in the Name text
box.
21. In the Range text box, type an interpretation range value.
22. For the appropriate interpretation, tap the Review Required check box.
release when the Hold option is configured for the Result Release Mode and the results are
within the specific interpretation range.
23. For each available interpretation, repeat steps 20, page 304 through 22, page 305.
24. To save the edits to the review result settings, tap Save.
To delete the edits to the review result settings, tap Cancel.
25. Tap the Retest Rules tab.
26. Under Assay Retest Rules on the Retest Rules tab of the Assay Parameter screen, type
the name in the Retest Rule Name text box.
27. If the criteria is based on result ranges, perform the following steps:
a. In the Result Indicator area, tap the Result Range option.
b. To enter a result range, perform one of the following steps:
28. If the criteria is based on interpretations, perform the following steps:
a. In the Result Indicator area, tap the Interpretation option.
b. In the Interpretation drop-down list, tap an interpretation.
29. If the criteria is based on exceptions, tap the Exception option in the Result Indicator area.
– 1037 Unable to calculate result. Rate reaction linearity failure.
– 1038 Unable to calculate result. Insufficient absorbance reads within absorbance range.
– 1039 Unable to calculate result. Absorbance exceeded optical limits.
– 1040 Unable to calculate result. No absorbance reads within absorbance range.
– 1041 Unable to calculate result. Reaction check failure.

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– 1042 Unable to calculate result. ICT reference solution voltage drift error.
highest calibrator.
lowest calibrator.
– 1402 Unable to process test. Activated read failure.
– 1403 Unable to process test. Final read failure.
30. In the Original Dilution drop-down list, tap an original dilution.
31. Tap Retest Assays.
32. In the Select Retest Assays flyout, tap the retest assays.
33. To save the retest assay selection, tap Done.
34. Under Retest Dilution, tap a retest dilution in the Retest Dilution drop-down list for each
assay.
35. Under Replicates, tap the number of replicates in the Replicates drop-down list for each
assay.
36. To add additional retest assays, repeat steps 31, page 306 through 35, page 306.
37. To save the edits to the retest rule settings, tap Add Rule.
To delete the edits to the retest rule settings, tap Cancel.
38. To save the edits to the assay file and return to the Assay Parameters screen, tap Done.
Create a user-defined assay (c‑series photometric), page 1598
Calibrator Set screen

On the Calibrator Set screen, the operator can perform the following functions:
• View calibrator data.
• View or print calibrator value sheets.
• Create new calibrator lots by scanning the bar codes on the calibrator cartons.
The supervisor and the system administrator can perform the following functions:
• Manually create new calibrator lots or import calibrator data to create new calibrator lots.
• Edit calibrator data.

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• Delete calibrator lots.
The system administrator can delete imported calibrator data.
Calibrator Set screen element descriptions, page 307
Calibrator Set View/Edit screen element descriptions, page 308
Import Calibrators screen element descriptions (c‑series), page 309
View calibrator lot data, page 310
Create a new calibrator master lot (c‑series), page 311
Create a new calibrator master lot (i‑series), page 313
Import calibrator data (c‑series), page 314
Delete imported calibrator data (c‑series), page 315
Delete a calibrator lot, page 316
Descriptions of calibrator import statuses (c‑series), page 317
Edit calibrator data (c‑series), page 317
Edit calibrator data (i‑series), page 319
View or print a calibrator value sheet (c‑series), page 320
Calibrator Set screen element descriptions

The Calibrator Set screen displays the calibrator sets that are configured on the system.
Element
Calibrator Sets Displays the total number of calibrator sets that are
Function buttons
View/Edit Navigates to the Calibrator Set View/Edit screen for the

selected calibrator set.
Delete Displays a message requesting confirmation to delete the

selected items.
Import Navigates to the Import Calibrators screen.

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Calibrator Set View/Edit screen element descriptions

The Calibrator Set View/Edit screen displays the data for the selected calibrator set.
Elements
Calibrator Set Name Displays the name of the selected calibrator set.
Master Lot Displays the master lot number of the selected calibrator set.
The master lot number is located on the label of the calibrator
vial or bottle and is designated by the CN symbol. The master
lot number corresponds to the lot number of the material
contained in the calibrator vial or bottle. The master lot
number can have a maximum of nine characters, but a level
character can be appended at the end of the number.
NOTE: The lot symbol on the carton label represents the lot
number of the packaged kit. The following list provides two
examples:
• CN 74297LI00A is Master Lot 74297LI00.
• CN 49059M5001 is Master Lot 49059M500.
Default Displays a check box that is used to identify the master lot
number that is displayed as the default master lot number for
the calibrator set.
NOTE: The first configured master lot number is identified as
the default master lot number. The default master lot number
can be changed when two or more lot numbers are
configured.
Expiration Date Displays the expiration date of the selected calibrator set.
Level Displays the number of levels defined for the calibrator set.
Concentration values must be defined for all levels of the
default master lot number.
Assay Identifies the name of the assays in the calibrator set.
Cal A through Cal F Displays the concentrations of calibrator levels A through F.

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Cal 1 through Cal 6 Displays the concentrations of calibrator levels 1 through 6.
Low, High Displays the concentrations of the low and high calibrators.
Function buttons


Save Saves changes.

selected items.
Import Calibrators screen element descriptions (c‑series)

The Import Calibrators screen displays the calibrator files that are available for import to the
selected calibrator set. The calibrator files are used to configure a new lot number for an
existing calibrator set and can be located on the system or on a USB flash drive.
Elements
Calibration Set Displays the calibrator set name of the calibrator data file
selected for import.
Lot Number Displays the lot number of the calibrator data file selected for
import.
Number of Levels Displays the number of calibrator levels defined for the
calibrator data file selected for import.
Expiration Date Displays the expiration date of the calibrator data file selected
for import.

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selected folder.
Calibrator Files Displays the calibrator data files in the specified folder that
are available for import for the selected calibrator set.
File Assay/Number Displays the assay name and assay number for each assay in
the calibrator data file selected for import.
System Assay/Number Displays the assay name and assay number for each assay
on the system that corresponds to the assay number in the
calibrator data file selected for import.
Status Displays the import status of the assay. Data for an assay that
has a status of OK is imported. Data is not imported for
assays that have the following statuses:
• No Assay
• Previously Defined
Function buttons

Delete Deletes the selected calibrator file on the hard drive. Files on
a USB flash drive cannot be deleted.
Import Imports the selected calibrator file.
View calibrator lot data

Perform this procedure to view calibrator lot data for configured calibrator sets.

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3. On the Assay tab of the Configure screen, tap Calibrator Set.
4. In the list on the Calibrator Set screen, tap a calibrator set.
5. Tap View/Edit to display the calibrator data for the default master lot number.
6. In the Master Lot drop-down list under Calibrator Set Configuration, tap other calibrator
master lot numbers to display.
7. To return to the list of calibrator sets on the Calibrator Set screen, tap Done.
Create a new calibrator master lot (c‑series)
Operator access level Operator and supervisor
Perform this procedure to create a new calibrator master lot for an existing calibrator set.
Operators can create a new calibrator master lot by scanning a bar code on a calibrator kit.
NOTE: The product documentation for calibrators that have this capability states that calibrator
lots may be configured by using the bar code label on the calibrator carton.
Supervisors can configure parameters manually for a new calibrator master lot and can edit
calibrator values. The supervisor access level is necessary to configure a new calibrator master
lot for calibrators that have lot-specific calibrator values.
IMPORTANT: When the bar code on the calibrator carton is scanned, only the master lot
number and the expiration date are updated. The calibrator values remain from the previously
configured master lot. To configure a new master lot for calibrators that have lot-specific
calibrator values, the supervisor must verify that the correct values are entered and must edit
them if necessary, or the supervisor must configure the master lot by importing the calibrator
data.
NOTE: Calibrator data is retained on the system for a time period of 6 months past the calibrator
expiration date. After the time period has elapsed, the system automatically deletes the
calibrator data.

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NOTE: The first configured master lot number is designated automatically as the default
master lot number.
6. Use the bar code scanner to scan the bar code on the calibrator carton.
The system automatically creates a new calibrator master lot with the master lot number
and expiration date from the bar code on the calibrator carton.
To manually enter the master lot number and the expiration date, perform the following
steps:
a. In the Master Lot drop-down list under Calibrator Set Configuration, tap New Lot.
b. In the Master Lot text box, type the calibrator master lot number.
The master lot number is located on the label of the calibrator vial or bottle and is
designated by the CN symbol. The master lot number corresponds to the lot number of
the material contained in the calibrator vial or bottle. The master lot number can have a
maximum of nine characters, but a character that represents the calibrator level is
appended at the end of the number. The following list provides two examples:
c. In the Expiration Date text box, type the calibrator expiration date.
7. To configure the new calibrator master lot as the default, tap the Default check box.
master lot number. The default master lot can be changed when the instrument status is
Running or Processing if no orders are present for the calibrator set and if the calibrator set
is not loaded in the reagent carousel. The data must be defined for all assays and all levels
of the default master lot.
8. In the Store Onboard area, tap Yes or No to indicate whether the calibrator set is stored in
the reagent carousel:
– If Yes is selected, type the number of hours in the Onboard Stability (Hours) text box.
NOTE: Onboard storage capability is available for some calibrators. To identify the
calibrators that have this capability and the onboard stability time for each calibrator,
see the product documentation.
– If No is selected, proceed to step 9, page 312.
9. Perform one of the following steps:
– Enter a calibrator value for each assay and each level in the calibrator set.
NOTE: Before entering the calibrator values, ensure that the Result Units parameter of
the assay file aligns with the result units of the calibrator values to be entered.
– Confirm that the entered value for each assay and each level in the calibrator set aligns
with the calibrator master lot. Edit the values if necessary.
10. To save the calibrator master lot settings, tap Save.
To delete the calibrator master lot settings, tap Cancel.

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Automated calibration ordering, page 656
New Cal Set flyout element descriptions (c‑series photometric, user defined), page 1563
Create a new calibrator master lot (i‑series)

Perform this procedure to create a new calibrator master lot for an existing calibrator set by
scanning the bar code on the calibrator carton.
NOTE: Calibrator data is retained on the system for a time period of 6 months past the calibrator
expiration date. After the time period has elapsed, the system automatically deletes the
calibrator data.
master lot number.
6. Use the bar code scanner to scan the bar code on the calibrator carton.
The system automatically creates a new calibrator master lot with the master lot number
and expiration date from the bar code on the calibrator carton.
To manually enter the master lot number and the expiration date, perform the following
steps:
a. In the Master Lot drop-down list under Calibrator Set Configuration, tap New Lot.
b. In the Master Lot text box, type the calibrator master lot number.
The master lot number is located on the label of the calibrator vial or bottle and is
designated by the CN symbol. The master lot number corresponds to the lot number of
the material contained in the calibrator vial or bottle. The master lot number can have a
maximum of nine characters, but a character that represents the calibrator level is
appended at the end of the number. The following list provides two examples:
c. In the Expiration Date text box, type the calibrator expiration date.

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7. To configure the new calibrator master lot as the default, tap the Default check box.
master lot number. The default master lot can be changed when the instrument status is
Running or Processing if no orders are present for the calibrator set. The data must be
defined for all assays and all levels of the default master lot.
8. To save the calibrator master lot settings, tap Save.
To delete the calibrator master lot settings, tap Cancel.
Import calibrator data (c‑series)
Required materials A calibrator data file on a USB flash drive or on the hard drive
Perform this procedure to import calibrator data files to create a new calibrator lot for a
configured calibrator set.
NOTE: Imported calibrator data is retained on the system for a time period of 6 months past the
calibrator expiration date. After the time period has elapsed, the system automatically deletes
the imported calibrator data.
Calibrator data files may be accessed at abbottdiagnostics.com or may be requested through
Abbott Mail.
5. Tap Import.
On the Import Calibrators screen, the Hard Drive button is selected.
6. Tap the calibrator data file to import.
If the calibrator data file is located on a USB flash drive, perform the following steps:
a. Insert the USB flash drive.
b. Tap the USB Flash Drive button.

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c. Tap the appropriate folder.

d. Tap the calibrator data file to import.
NOTE: The assay names and assay numbers for the data in the file and for the
corresponding system assays are displayed with an import status. Data for all calibrator
levels is imported for assays that have a status of OK. No data is imported for assays that
have a status of No Assay or Previously Defined. These statuses are displayed in red text.
7. For the selected calibrator data file, perform one of the following steps:
– If no data is available to import because the assays have a status of No Assay or
Previously Defined, tap Done to return to the Calibrator Set screen and end the
procedure.
– To import the data for assays that have a status of OK, tap Import.
8. Under Calibrator Set Configuration on the Calibrator Set screen, tap the Default check box
to configure the calibrator master lot as the default.
master lot number.
The default master lot number can be changed when the instrument status is Running or
Processing if no orders are pending for the calibrator set and the calibrator set is not loaded
in the reagent carousel. For all assays and all levels of the default master lot number, the
data must be defined.
9. To save the calibrator data file settings, tap Save.
To delete the calibrator data file settings, tap Cancel.
11. If a USB flash drive was inserted, remove the USB flash drive.
Calibrator data files that are imported from a USB flash drive are saved to an internal storage
location on the system. To reinstall the calibrator data files on a future date, tap the Hard Drive
button.
Delete imported calibrator data (c‑series)
Perform this procedure to delete calibrator data files from the user interface computer. After a
calibrator data file is deleted, the file is unavailable to be reinstalled.

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NOTE: This procedure cannot be used to delete calibrator data files from a USB flash drive.
Imported calibrator data is deleted automatically from the system 6 months after the calibrator
data has reached the expiration date.
5. Tap Import.
On the Import Calibrators screen, the Hard Drive button is selected.
6. In the Calibrator Files list, tap the calibrator data file to delete.
7. Tap Delete.
8. To delete the calibrator data file, tap Continue.
To cancel the delete function, tap Cancel.
Delete a calibrator lot

status
Perform this procedure to delete a calibrator master lot number.

NOTE: The default master lot number cannot be deleted. To delete a master lot number that is
configured as the default, first change the default master lot number.
The calibrator master lot number is deleted automatically from the system 6 months after the
calibrator lot has reached the configured expiration date.
1. On the menu bar, tap System and then tap Configure.

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6. In the Master Lot drop-down list under Calibrator Set Configuration, tap a calibrator
master lot number that is not the default.
7. Tap Delete.
8. When a confirmation message is displayed, tap Continue.
Descriptions of calibrator import statuses (c‑series)

Calibrator import status information is used to resolve issues that occur when calibrator data is
imported. The system displays one calibrator import status for each assay on the Import
Calibrators screen.
The following list provides descriptions of the calibrator import statuses:
OK The imported assay has the same assay number and result
units as the assay that was configured on the system. The
data is imported.
No Assay No assay on the system has the same assay number in the
imported file. The data is not imported.
Previously Defined The data has been manually entered or imported. The data is
not imported.
Edit calibrator data (c‑series)

status
Perform this procedure to edit calibrator data settings.


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7. To configure the calibrator master lot number as the default, tap the Default check box.
NOTE: The default master lot number can be changed when the instrument status is
Running or Processing if no orders are pending for the calibrator set and the calibrator set
is not loaded in the reagent carousel. The default master lot number can be changed when
the instrument status is Idle if the calibrator set is not loaded in the reagent carousel. The
default master lot number must include all assays that are assigned to the calibrator set.
8. In the Expiration Date text box, enter the calibrator expiration date.
NOTE: The expiration date cannot be edited if one of the following situations occurred:
– The calibrator master lot number has expired.
– The calibrator master lot number was created by scanning the bar code on the
calibrator carton.
– The calibrator master lot number was created by importing calibrator data.
9. In the Store Onboard area, tap Yes or No to indicate whether the calibrator set is stored in
the reagent carousel:
– If Yes is selected, type the number of hours in the Onboard Stability (Hours) text box.
NOTE: Onboard storage capability is available for some calibrators. To identify
calibrators that have this capability and the onboard stability time for each calibrator,
see the product documentation.
– If No is selected, proceed to step 11, page 318.
10. For photometric assay calibrator sets, tap Level, and then enter a calibrator value to
increase the number of levels in the calibrator.
NOTE: The number of calibrator levels cannot be decreased for a previously configured
calibrator. For all enabled assays and all levels of the default master lot number, the data
must be defined.
11. Enter calibrator values for all levels of each enabled assay if the values are not present.
NOTE: Calibrator values cannot be edited for a calibrator master lot number that is created
by scanning the bar code on the calibrator carton label.
12. To delete the selected calibrator master lot number, perform the following steps:
a. Tap Delete.
b. When a confirmation message is displayed, tap Continue.
NOTE: A calibrator master lot number cannot be deleted if the master lot number is the
default or if the calibrator is loaded in the reagent carousel.
13. To save the edits to the calibrator master lot settings, tap Save.

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To delete the edits to the calibrator master lot settings, tap Cancel.
14. To edit another calibrator master lot number, tap a master lot number in the Master Lot
drop-down list, and then repeat steps 7, page 318 through 13, page 318.
Edit calibrator data (i‑series)

status
Perform this procedure to change the default calibrator master lot number and to delete a
calibrator master lot number.
7. To configure the calibrator master lot number as the default, tap the Default check box.
NOTE: The default master lot number can be changed when the instrument status is
Running or Processing if no orders are pending for the calibrator set. The default master lot
number must include all assays that are assigned to the calibrator set.
8. To delete the selected calibrator master lot number, perform the following steps:
a. Tap Delete.
b. When a confirmation message is displayed, tap Yes.
NOTE: A calibrator master lot number cannot be deleted if the master lot number is the
default.
9. To save the edits to the calibrator master lot settings, tap Save.
To delete the edits to the calibrator master lot settings, tap Cancel.
10. To edit another calibrator master lot number, tap a master lot number in the Master Lot
drop-down list, and then repeat steps 7, page 319 through 9, page 319.

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View or print a calibrator value sheet (c‑series)
Required materials USB flash drive (Print to File option only)
Perform this procedure to view or print a calibrator value sheet or to save the calibrator value
sheet as a portable document format (PDF) file.
NOTE: A calibrator value sheet is available only for a calibrator master lot that was created from
an imported file that has not previously been deleted on the hard drive.
7. Tap Print.
8. Under Report Selection in the Print flyout, tap Calibrator Insert.
9. To rotate the document, use the Rotate toolbar.
10. To browse the document, use the Page toolbar.
11. To increase or decrease the font size in the document, use the Zoom toolbar.
12. To fit the document to the window width ( ) or to resize the document to fit one full page in
the window ( ), use the Fit toolbar.
13. To find a word or phrase in the document, use the Find toolbar.
14. In the Print flyout, choose a printer or tap Print to File in the Print Location drop-down list.
15. To print the document, enter the number of copies to print, and then tap Print.
16. If Print to File was selected in the Print Location drop-down list, perform the following
steps to indicate the file destination:
a. Insert a USB flash drive.
b. Tap the appropriate USB flash drive.
c. Tap the destination folder.

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d. Tap OK.
e. Remove the USB flash drive.
17. To return to Calibrator Set Configuration on the Calibrator Set screen, tap Done.
Install/Uninstall Assays screen

On the Install/Uninstall Assays screen, the operator can view or print assay installation reports.
• Install assays.
• Uninstall assays.
• Delete assays on the hard drive.
Install/Uninstall Assays screen, Installed Files tab element descriptions, page 323
Descriptions of file update statuses, page 324
Descriptions of assay file reagent statuses, page 325
Uninstall assay files, page 327
Delete assay files, page 328
Install/Uninstall Assays screen, Available Files tab element descriptions

The Available Files tab displays all assay files that are available for installation on the system or
on a USB flash drive.
Elements
Available Assays Displays the number of assays that are available for
installation for the currently selected option.
All option Displays all assay files that are available for installation.
i‑series option Displays all assay files that are available for installation on
one or more Alinity i processing modules.

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c‑series option Displays all assay files that are available for installation on
one or more Alinity c processing modules.
Calculated option Displays all calculated assay files that are available for
installation.
Status Displays the status of the file installation. The status includes
file integrity and file installation success or failure.

selected folder.
Assay Name Displays the name of the assay file.
Version Displays the version of the assay file.
Update Status Displays the file update status of all assay files that are
available on the system.
The Available Files tab has five file update statuses:
• Current
• New
• Update
• Installed
• Previous
Reagent Status Displays the assay file reagent status to determine if a new
reagent lot is necessary to support a new assay file.
The Available Files tab has three assay file reagent statuses:
• OK
• New reagent needed
• Unknown

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Function buttons

Install Installs the selected files on the current screen.

selected items.
Descriptions of assay file reagent statuses, page 325
Install/Uninstall Assays screen, Installed Files tab element descriptions

The Installed Files tab displays all assay files that are installed on the system.
Elements
Installed Assays Displays the number of assays installed for the currently
selected option.
All option Displays all assay files that are available for installation.
i‑series option Displays all assay files that are available for installation on
one or more Alinity i processing modules.
c‑series option Displays all assay files that are available for installation on
one or more Alinity c processing modules.
Calculated option Displays all calculated assay files that are available for
installation.

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Version Displays the version of the assay file
Release Status Displays the status of the assay file. The Installed Files tab
has one file status: Released.
Function buttons

Uninstall Displays a message requesting confirmation to uninstall files

from the user interface.
Descriptions of file update statuses

File update status information is used to determine if an assay file or a procedure file is new, is
updated, or is installed on the system.
The following list provides descriptions of the file update statuses. The statuses are described in
the order in which they are sorted:
Current The file is the same version as the file that is installed on the
system.
New The file is not installed on the system.
Update The file is a newer version than the file that is installed on the
system.

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Installed The file was installed successfully.

NOTE: Installed is a temporary status that is updated after the
screen is refreshed.
Previous The file is an older version than the file that is installed on the
system.
Install/Uninstall Procedures screen, page 367
Descriptions of assay file reagent statuses

Assay file reagent status information is used to determine if a new reagent lot is necessary to
support a new assay file.
The following list provides descriptions of the assay file reagent statuses. The statuses are
described in the order in which they are sorted:
OK A new reagent lot is not necessary to support the new assay

file.
New reagent needed A new reagent lot is necessary to support the new assay file.
Unknown The assay file is new and has not been installed previously on
the system. The reagent lot information is unknown.
Install assay files

status
Required materials An assay file on the hard drive or on a USB flash drive
Perform this procedure to install assay files on the system.

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NOTE: When an assay is installed that uses the data from a reference assay, the reference
assay must be installed first.
3. On the Assay tab of the Configure screen, tap Install/Uninstall Assays.
On the Available Files tab of the Install/Uninstall Assays screen, the Hard Drive button is
selected.
NOTE: If the assay is located on a USB flash drive, insert the USB flash drive, and then tap
the USB Flash Drive button.
4. Under Assays on the Available Files tab, tap one or more assay files to install (or tap
Select All).
NOTE: To filter the list of installed assay files, tap the option for i-series, c-series, or
Calculated.
5. To print the assay-specific installation information, tap Print.
6. Review the specific information for each assay before installation.
Assays may have specific installation requirements.
7. Tap Install.
8. When a confirmation message is displayed because an updated assay file requires a new
version of the reagent, refer to the assay-specific installation information to verify the
reagent requirements.
Do not install the new assay file until the correct reagent has been received.
Tap one of the following options:
– Tap Yes to install the new assay file.
– Tap No to cancel the specific assay installation.
– Tap Cancel to cancel all assay file installations if more than one assay file was
selected.
9. When a confirmation message is displayed because an assay file requires an update, tap
one of the following options:
– Tap Yes to install a correlation version of the assay file.
NOTE: The original assay file version and the correlation assay file version remain in
the system software so that both versions of the assay file can be run concurrently.
– Tap No to replace the original assay file with the new assay file.
– Tap Cancel to cancel the assay installation and return to the Install/Uninstall Assays
screen.

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10. Refer to the assay-specific installation information for specific calibration and quality control
requirements.
Calibration and all levels of controls may need to be run before results are reported.
Assay files that are installed from a USB flash drive are saved to an internal storage location on
the system.
Uninstall assay files, page 327
Create a control order, page 686
Create a calibration order, page 688
Uninstall assay files

status
Perform this procedure to uninstall assay files from the system software. Assay files remain
available to be reinstalled from the Available Files tab of the Install/Uninstall Assays screen.
NOTE: An assay file cannot be uninstalled if the assay file is referenced by another assay, has
pending orders, is a constituent of a calculated assay, or is a primary assay of the correlation
version that is installed.
When an assay file is uninstalled, calibrations for the assay file and any assay configuration
including controls are deleted.
4. On the Install/Uninstall Assays screen, tap the Installed Files tab.
5. On the Installed Files tab, tap one or more assay files to uninstall (or tap Select All).
Calculated.
6. Tap Uninstall.

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Delete assay files

status
Perform this procedure to delete assay files from the user interface computer. After an assay
file is deleted, the assay file is unavailable to be reinstalled.
NOTE: An assay file cannot be deleted if the assay file is referenced by another assay, has
pending orders, or is a constituent of a calculated assay.
4. On the Available Files tab of the Install/Uninstall Assays screen, tap one or more assay
files to delete (or tap Select All).
Calculated.
5. Tap Delete.
Import/Export Assays screen (c‑series)

On the Import/Export Assays screen, the operator can export assay files for import on an
Alinity ci‑series by using a c‑series processing module.
The system administrator can import assay files to an Alinity ci‑series by using a c‑series
processing module.

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Select Items window element descriptions (c‑series), page 331
Export assay files (c‑series), page 331
Import assay files (c‑series), page 332
Import/Export Assays screen, Export Files tab element descriptions (c‑series)

The Export Files tab displays all c‑series photometric assay files that are available to export.
Elements
Status Displays the status of the assay to be exported or when an

attempt has been made to export an assay.
Release Status Displays the status of the assay file. The Installed Files tab
has one file status: Released.
Function buttons

Export Initiates the process to export an assay file.
Import/Export Assays screen, Import Files tab element descriptions (c‑series)

The Import Files tab displays all assay files that are available to import from a USB flash drive.

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Elements
Status Displays the status of the file import. The status includes file
integrity and file import success or failure.

selected folder.
Update Status Displays the status of the assay file. The Import Files tab has
five file update statuses:
• Current
• New
• Update
• Installed
• Previous
Function buttons

Import Imports the selected files.

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Select Items window element descriptions (c‑series)

The Select Items window displays the drive and folders that are used to export an assay file.
Elements

selected folder.

folders.
updated.
Function buttons
OK Saves the file and closes the window.

Export assay files (c‑series)
Perform this procedure to export c‑series photometric assay files.

NOTE: Multiple versions of the same assay file can be exported to the same location on a USB
flash drive.
If an assay file is exported to a location occupied by the same assay file and version number,
the data in the existing file is overwritten.

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4. On the Assay tab of the Configure screen, tap Import/Export Assays.
5. On the Export Files tab of the Import/Export Assays screen, tap one or more of the installed
assay files (or tap Select All).
6. Tap Export.
7. On the Export screen, select the file location for the exported assay files:
a. Tap the appropriate USB flash drive.
b. Tap the appropriate folder.
8. To complete the export of the assay files, tap OK.
NOTE: In the Status area, a message is displayed that contains the name, number, and
version of each exported assay file and is displayed for any error conditions that occur.
If the USB flash drive has insufficient space for all the assay files that are exported, only
the assay files that can fit on the USB flash drive are exported.
Exported assay files can only be imported. They cannot be installed on the Install/Uninstall
Assays screen.
Import assay files (c‑series)

status
Required materials One or more exported c‑series photometric assay files on a

USB flash drive
Perform this procedure to import c‑series photometric assay files.

NOTE: Exported assay files can only be imported. They cannot be installed on the Install/
Uninstall Assays screen.

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4. On the Assay tab of the Configure screen, tap Import/Export Assays.
5. On the Import/Export Assays screen, tap the Import Files tab.
6. On the Import Files tab, tap the appropriate USB flash drive and folder that contain the
exported assay files.
NOTE: Exported assay files that have an invalid checksum cannot be imported and are not
displayed in the folder.
7. Tap one or more of the exported assay files (or tap Select All).
8. Tap Import.
NOTE: In the Status area, a message is displayed that contains the name, number, and
version of each imported assay file and is displayed for any error conditions that occur. The
assay status of an imported assay file is Installed.
The parameter for Run Controls for Onboard Reagents by is configured as the default for
assay files that do not have the parameter configured. The assay-specific setting is retained
for the imported assay files if the setting is configured.
The import is not completed in the following instances:
– An exported assay with the same version number is present on the system.
– An exported assay requires a reference assay and the reference assay is not installed.
Assay files that have the parameter for Calibrator Set configured as None are enabled when
they are imported.
If an assay file has a setting other than None configured as the parameter for Calibrator Set,
the assay file is disabled and the calibrator concentration values are deleted when the assay file
is imported.
Assay Display Order screen

On the Assay Display Order screen, the operator can view assay display order settings.
The system administrator can configure the assay display order on the user interface and for
reports.

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Assay Display Order screen element descriptions, page 334
Configure the assay display order, page 335
Assay Display Order screen element descriptions

On the Assay Display Order screen, the system administrator can configure the order in which
assays are displayed on screens and flyouts that have an assay list and in the following reports:
• Sample Laboratory Report
• Sample Status Report
• QC Summary Report
Elements
Display Order Applies Displays the following options to indicate the areas to which
to the configured display order is applied:
Reports Only The configured assay display order is

displayed only on printed reports.
Reports and Displays The configured assay display order is

applied to user interface computer
screens that have an assay list and to
the previously listed reports.
Assay Displays a list of the assays that are installed on the system.
Display Order Displays the assay display order list.
Function buttons


Add> Moves the selected assays from the Assay list to the Display
Order list in the order in which the assays were selected.
<Reset Moves the selected assay from the Display Order list to the
Assay list.

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Insert Before Inserts an assay, or a group of assays in the order in which

the assays were selected, before the selected assay in the
Display Order list.
Insert After Inserts an assay, or a group of assays in the order in which

the assays were selected, after the selected assay in the
Display Order list.
<<Reset All Moves all assays from the Display Order list to the Assay list.
Configure the assay display order
Perform this procedure to configure the assay display order on the following user interface
elements:
• Screens and flyouts that have an assay list
• The sample laboratory report, the sample status report, and the quality control summary
report
NOTE: When the assay display order is defined, assays are displayed in the defined order on
screens and in reports as configured. Any new assays and assays that are not defined in the
display order are displayed in alphanumeric order on screens and in reports after the assays in
the display order.
3. On the Assay tab of the Configure screen, tap Assay Display Order.
4. In the Display Order Applies to area of the Assay Display Order screen, tap Reports Only
or Reports and Displays.
5. To edit the assay display order, perform one of the following steps:
– To add assays to the end of the Display Order list, in the Assay list, tap each assay in
the order to display, and then tap ADD>.
– To insert assays in the Display Order list, in the Assay list, tap each assay in the order
to display. Tap the assay in the Display Order list where the assays need to be

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inserted, and then tap Insert Before or Insert After. The assays are inserted in the
selected location.
– To change the order of the assays in the Display Order list, tap the assays that need to
be moved, and then tap Reset. The assays are moved to the Assay list. Perform one of
the previous two steps to move the assays to the Display Order list in the correct order.
– To move all assays from the Display Order list to the Assay list, tap <<Reset All.
6. To save the edits to the display order settings and return to the Configure screen, tap Done.
To delete the edits to the display order settings and return to the Configure screen, tap
Cancel.
Panel Definition screen

On the Panel Definition screen, the operator can view panel definitions for specimens, quality
control (QC), and calibrations.
• Configure new panels for specimens, QC, and calibrations.
• Edit an existing panel.
• Delete a panel.
Panel Definition screen element descriptions, page 336
Configure a panel, page 338
Edit a panel definition, page 338
Delete a panel, page 339
Panel Definition screen element descriptions

The Panel Definition screen displays the panel names and the constituent assays for panels that
are configured on the system.
Panel Configuration area
Panel Name Displays a text box that is used to enter the name of the
selected panel. The operator can type a new panel name that
can contain a maximum of 10 characters.
Panel Type Displays check boxes that are used to configure the screens
on which the panel is displayed:

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• If the Specimen check box is selected, the panel is

displayed on the Specimen tab of the Create Order
screen.
• If the Control check box is selected, the panel is
displayed on the Control tab of the Create Order screen.
• If the Calibration check box is selected, the panel is
displayed on the Calibration tab of the Create Order
screen.
Panels Displays a list of configured panels.

Assays Displays the configured assays on the system.
All option Displays all assays that are available on the system.
i‑series option Displays all assays that are available on one or more Alinity i
processing modules.
c‑series option Displays all assays that are available on one or more Alinity c
processing modules.
Calculated option Displays all calculated assays.
Number of Selected Displays the total number of assays in the panel.

Assays
Function buttons


Save Saves changes.

selected items.

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Configure a panel
Perform this procedure to configure a panel that can be used when ordering specimens, quality
control (QC), and calibrations. Twenty-five unique panels can be configured. A panel can be
configured with any combination of panel types, specimen, QC, and calibration.
3. On the Assay tab of the Configure screen, tap Panel Definition.
4. In the Panel Name box on the Panel Definition screen, type a panel name.
NOTE: A panel name can have a maximum of 10 characters.
5. In the Panel Type area, tap the one or more check boxes.
6. In the Assays list, tap one or more individual assays to include in the panel.
NOTE: To filter the list of assays, tap the option for i-series, c-series, or Calculated.
7. To save the edits to the panel settings, tap Save.
To delete the edits to the panel settings, tap Cancel.
Edit a panel definition
Perform this procedure to edit a panel definition. When a defined panel is edited, existing orders
are not affected.
4. In the Panels list on the Panel Definition screen, tap a panel to edit.
5. Edit any of the following information:
– Panel Name

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NOTE: When a panel name is edited, a new panel is created. If the original panel is not
needed, it must be deleted.
– Panel Type
– Assays
6. To save the edits to the panel settings, tap Save.
To delete the edits to the panel settings, tap Cancel.
Delete a panel, page 339
Delete a panel
Perform this procedure to delete a panel. When a defined panel is deleted, existing orders are
not affected.
4. In the Panels list on the Panel Definition screen, tap a panel to delete.
5. Tap Delete.
Edit a panel definition, page 338
Cal/QC Ordering screen

On the Cal/QC Ordering screen, the operator can view calibration and quality control settings.
• Configure the ability to use calibrations that are beyond the calibration expiration.
• Configure the ability to use calibrators that are beyond the calibrator lot expiration.
• Configure the ability to use controls that are beyond the control lot expiration.

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• Configure the ability to disable a reagent when a control fails.

• Configure the ability to require quality control to run after a calibration is generated.
• Configure whether the control expiration date must be entered before an order is created.
Cal/QC Ordering screen element descriptions, page 340
Configure calibration and control ordering settings, page 341
Cal/QC Ordering screen element descriptions

The Cal/QC Ordering screen displays the calibration and quality control settings.
Elements
Calibration Configuration area

Displays calibration configuration settings.
Calibration Expiration Used to override a calibration status of Expired. One of the

Override following options is enabled:
• On
• Off (default)
Calibration Lot Used to configure if an expired calibrator lot expiration can be

Expiration Override overridden. One of the following options is enabled:
• On
• Off (default)
Control Configuration area

Displays control configuration settings.
Control Lot Expiration Used to override a control status of Expired. One of the
Override following options is enabled:
• On
• Off (default)
Disable Reagent on Used to configure if a reagent needs to be disabled for a

Control Failure quality control failure. One of the following options is enabled:

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• On
• Off (default)
Control Required After Used to configure if quality control must be run after a
Calibration calibration is generated. One of the following options is
enabled:
• On
• Off (default)
Entry of Expiration Used to configure if an expiration date must be entered for all
Date Required control material before a control order can be created. One of
the following options is enabled:
• On
• Off (default)
Function buttons


Save Saves changes.
Configure calibration and control ordering settings

status
Perform this procedure to configure calibration and control ordering settings.


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3. On the Assay tab of the Configure screen, tap Cal/QC Ordering.

4. Under Calibration Configuration on the Cal/QC Ordering screen, enter the following
information:
– Calibration Expiration Override
– Calibrator Lot Expiration Override
5. Under Control Configuration, enter the following information:
– Control Lot Expiration Override
– Disable Reagent on Control Failure
– Control Required after Calibration
– Entry of Expiration Date Required
6. To save the edits to the ordering settings, tap Save.
To delete the edits to the ordering settings, tap Cancel.
Quality Control screen

On the Quality Control screen, the operator can view quality control settings.
The supervisor can perform the following functions:
• Configure multiconstituent and single-constituent controls.
• Edit multiconstituent and single-constituent controls.
• Import control data.
• Delete a quality control.
Quality Control screen element descriptions, page 343
Set Stability flyout element descriptions, page 347
Import screen element descriptions, page 348
Manually create a new quality control lot, page 349
Edit a quality control, page 353
Add an assay to a quality control, page 357
Delete an assay from a quality control, page 358
Delete a quality control lot, page 359

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Delete a quality control, page 360

Import quality control data, page 361
Delete imported quality control data, page 363
View or print a quality control insert, page 363
Descriptions of quality control import statuses, page 364
Quality Control screen element descriptions

The Quality Control screen displays the quality controls that are configured.
Elements
Control Count Displays the total number of quality controls that are
configured.
Selected Assays Displays the number of assays selected for control

configuration.
Function buttons
Create Navigates to the Control Create/Edit screen where a new

quality control can be created.
View/Edit Displays the Control Create/Edit screen for the selected

quality control.

selected items.
Import Navigates to the Import screen where the selected quality
control can be imported.
Control Create/Edit screen element descriptions

On the Control Create/Edit screen, the operator can create a new quality control configuration or
can edit an existing quality control configuration.

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Control Configuration area
Control Name Displays the name of quality control.
Lot Displays the lot number of the selected quality control.
Default Displays a check box that is used to identify the lot number
that is displayed as the default lot number for control orders.
NOTE: The first configured lot number is designated
automatically as the default lot number. To change the default
lot number, two or more control lot numbers must be
configured.
Expiration Date Displays the expiration date of the selected quality control.
Level Displays the level number that corresponds to the listed

control data.
Level Name Displays the level name that corresponds to the level number.
Automated Identifies the control as one that is periodically evaluated for

automated control ordering when the Yes option is selected.
Stored Onboard Indicates that the quality control is stored on the reagent
carousel. This area is available only if Yes was selected in
the Automated area.
Low Alert Volume (%) Indicates the percent remaining volume at which low alert
flags are generated. This area is available only if Yes was
selected in the Automated area.
Start Time Identifies the shift start time for the control if the Use Module
Shift Time check box is not selected. This area is available
only if Yes was selected in the Automated area.
Use Module Shift Displays a check box that is used to identify the control as
Time one that uses the system-configured module shift time to
define control run intervals. The check box is available only if
Yes was selected in the Automated area.
Time Interval Displays the time interval in minutes, after the shift start time,
(Minutes) that is used to create automated orders for the control. This
area is available only if Yes was selected in the Automated
area.

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Onboard Stability Displays the maximum time in hours that the control can
(Hours) remain on the reagent carousel. This area is available only if
Yes was selected in the Stored Onboard area.
NOTE: Onboard stability tracking occurs after the vial is
scanned by the RSM bar code reader and is scheduled to be
loaded in the reagent carousel. The onboard stability tracking
continues when the vial is unloaded from the system. The
data row of an assay with an analyte stability that is greater
than or equal to the control onboard stability is highlighted in
blue.
The onboard stability time can be edited for a control that is
stored on the system to match the onboard stability time of
the analyte that has the shortest, nonzero analyte stability.
In-Use Stability Displays the maximum time in hours that the control can be
(Hours) used on the processing module without refrigerated storage. A
value of zero indicates that in-use stability is not tracked.
Assay check box Enables all assays in the control level for testing when the
Assay check box is selected. Individual assays can be
enabled or disabled for the control level by selecting or
clearing the check box for the corresponding assay name.
Disabled multiconstituent control assays are not run when the
control level is ordered.
Assay Identifies the name of each assay in the control. For

multiconstituent controls that are stored on the system, the
data row of assays that are enabled for onboard use is
highlighted in blue. When the assay is disabled, the data row
is not highlighted.
Expected 1 SD Displays the value that represents the expected one standard
deviation (SD) for the control level if configured.
Expected Mean Displays the expected mean value for the control level if
configured.
NOTE: Quality control reports, Levey-Jennings graphs, and
quality control summary data are not generated if the values
for Expected 1 SD and Expected Mean are not defined.
Manufacturer 1 SD Displays the manufacturer value that represents one SD for

the control level if configured.
Manufacturer Mean Displays the manufacturer mean value for the control level if
configured.

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Expected Range Low Displays the lower limit of the control range for the control
level if configured.
Expected Range High Displays the upper limit of the control range for the control
level if configured.
Default Dilution Displays the selected dilution for the assay for quality control
testing.
Test Interval Displays the test count interval used to create automated
orders for the control.
Time Interval Displays the time interval in minutes that is used to create
(Minutes) automated orders for the assay. The configured assay time
interval supersedes the configured control level time interval if
both intervals are defined for the same lot number.
Calculate Mean/SD Automatically calculates the Expected 1 SD and Expected

Mean values when the Expected Range Low and Expected
Range High values are entered and the check box is selected.
NOTE: To calculate the Expected 1 SD value, the Expected
Range Low value is subtracted from the Expected Range High
value and the difference is divided by four. To calculate the
Expected Mean value, the Expected Range Low value and the
Expected Range High value are added and the sum is divided
by two.
The automatic calculation cannot be performed if a value has
been entered in the Expected 1 SD box or the Expected
Mean box.
Function buttons



selected items.
Save Saves changes.

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Set Stability Navigates to the Set Stability flyout where onboard stability
values for individual analytes are displayed.
Set Stability flyout element descriptions

In the Set Stability flyout, the operator can view or edit the assay onboard stability time in hours
for a multiconstituent control.
Elements
Assay Displays the names of the assays configured for the

multiconstituent control.
Stability Hours Displays the onboard stability in hours for the control assay.
NOTE: Onboard stability cannot be edited for controls that are
currently stored on the system.
If the assay onboard stability is less than the configured
onboard stability for the control, the assay is disabled for
onboard use from the control and the data row for the assay
on the Control Create/Edit screen is not highlighted in blue.
The assay cannot be ordered or processed from the onboard
vial rack.
Multiconstituent control assays that are disabled for onboard
use can be ordered from vials in a vial rack, from a sample in
a sample cup, or from a bar-coded sample tube in a sample
rack when QQQ is added to the beginning of the SID.
Alternatively, the onboard stability time can be edited for a
control that is stored on the system to match the onboard
stability time of the disabled analyte.
Function buttons


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Import screen element descriptions

The Import screen displays the quality control files that are available for import. The quality
control files are used to configure a new control or to configure a new lot number for an existing
control. Quality control files can be located on the system or on a USB flash drive.
Elements
Control Name Displays the control name of the quality control file selected
for import.
Lot Number Displays the lot number of the quality control file selected for
import.
Number of Levels Displays the number of levels defined for the quality control
file selected for import.
Expiration Date Displays the expiration date of the quality control file selected
for import.

selected folder.
Quality Control Files Displays the quality control files in the specified folder that
are available for import for the selected control. If New
Control was selected on the Quality Control screen, all quality
control files in the specified folder are displayed.
File Assay/Number Displays the assay name and assay number for each assay in
the quality control file selected for import.

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System Assay/Number Displays the assay name and assay number for each assay
on the system that corresponds to the assay number in the
quality control file selected for import.
Status Displays the import status of the assay. Data for an assay that
has a status of OK is imported. Data is not imported for
assays that have the following statuses:
• No Assay
• Previously Defined
• Unit Mismatch
• Version Mismatch (only for Technopath control products)
File Units Displays the result units that are available for the quality
control file.
System Units Displays the result units that are available for the assay
installed on the system.
Function buttons

Delete Deletes the selected quality control file on the hard drive.
Files on a USB flash drive cannot be deleted.
Import Imports the selected quality control file.
Manually create a new quality control lot
Perform this procedure to create manually a new single-constituent control lot or multiconstituent
control lot.

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3. On the Assay tab of the Configure screen, tap Quality Control.
4. On the Quality Control screen, tap New Control.
5. In the Selected Assays list, tap one or more individual assays to include in the control.
NOTE: Correlation assays are unavailable for selection. The correlation assay is
automatically added to the control that contains the primary assay. Unique control ranges
cannot be configured for the correlation assay.
For calculated assays, ensure that the constituent assays are selected if the control will be
stored on the system.
6. Tap Create.
7. Under Control Configuration on the Control Create/Edit screen, type a control name in the
Control Name box.
NOTE: A control name can have from 1 through 10 characters.
8. To enter a control lot number, perform one of the following steps:
– Tap the Lot box, and then enter the control lot number.
– Tap the Lot box, tap New Lot, and then enter the control lot number.
NOTE: A control lot number can have from 3 through 9 characters. The first configured lot
number is designated automatically as the default lot number for control orders. To change
the default lot number, two or more control lot numbers must be configured.
A maximum of 20 lot numbers can be configured for a control name.
9. In the Expiration Date box, enter the control expiration date.
NOTE: If the Alinity ci‑series is configured to require a control expiration date, the expiration
date must be entered to create orders for the control.
10. In the Level drop-down list, confirm that the level identifier is correct.
If the level identifier is incorrect, tap a level in the drop-down list.
11. In the Level Name box, type a level name.
NOTE: A level name can have from 1 through 10 characters.
12. In the Automated area, tap Yes or No to indicate whether the system software needs to
periodically evaluate the control and to create orders according to configured time intervals
or test intervals.
13. In the Time Interval (Minutes) box, type the number of minutes to define the frequency to
create an automated order for the control.
NOTE: The Time Interval (Minutes) box is available only if Yes was selected in the
Automated area.

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14. To specify a shift start time for automated control orders to be created that differs from the
configured module shift start time, perform the following steps:
a. Tap to clear the Use Module Shift Time check box.
b. Use the HH:MM format to type a time in the Start Time box, and then tap AM or PM.
NOTE: The Use Module Shift Time check box and the Start Time box are available only if
15. In the Stored Onboard area, tap Yes or No to indicate whether the control can be stored in
the reagent carousel.
NOTE: The Stored Onboard area is available only if Yes was selected in the Automated
area.
Onboard storage capability is available for some controls. To identify controls that have this
capability and the onboard stability time for each control, see the product documentation.
16. In the Onboard Stability (Hours) box, type the number of hours.
NOTE: Onboard storage capability is available for some controls. To identify controls that
have this capability and the onboard stability time for each control, see the product
documentation.
17. In the Low Alert Volume (%) box, type the percentage value.
NOTE: The Low Alert Volume (%) box is available only if Yes was selected in the
Automated area.
18. If the in-use stability time is provided, type the number of hours in the In-Use Stability
(Hours) box.
NOTE: In-use stability reflects the maximum time that the control can be used on the
processing module without refrigerated storage. A value of zero indicates that in-use stability
is not tracked.
19. To disable one or more of the individual assays that were selected in step 5, page 350 from
the control level, tap to clear the check box next to the assay name.
NOTE: Disabled assays for a control level are not run when the control level is ordered.
To disable all the assays for a specific control level, tap the Assay check box. When all the
assays for the control level are disabled, the level is not run when the control is ordered.
20. Enter the following information for each assay:
– Expected 1 SD
– Expected Mean
NOTE: To calculate automatically the values for Expected 1 SD and Expected Mean
from an entered range, type a value in the Expected Range Low box, type a value in
the Expected Range High box, and then tap the Calculate Mean/SD check box for the
assay.
To calculate the Expected 1 SD value, the Expected Range Low value is subtracted
from the Expected Range High value and the difference is divided by four. To calculate

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the Expected Mean value, the Expected Range Low value and the Expected Range
High value are added and the sum is divided by two.
The automatic calculation cannot be performed if a value has been entered in the
Expected 1 SD box or the Expected Mean box.
NOTE: Quality control reports, Levey-Jennings graphs, and quality control summary
data are not generated if the values for Expected 1 SD and Expected Mean are not
defined.
– Manufacturer 1 SD
– Manufacturer Mean
– Expected Range Low
– Expected Range High
NOTE: To flag the controls automatically when the control results fall outside a specific
range, type a value in the Expected Range Low box and type a value in the Expected
Range High box.
To flag the controls automatically when the control results are less than a specific
value, type a value in the Expected Range Low box and leave the Expected Range
High box blank.
To flag the controls automatically when the control results are greater than a specific
value, leave the Expected Range Low box blank and type a value in the Expected
Range High box.
If neither the Expected Range Low value nor the Expected Range High value is
defined, control results are not evaluated for the application of the CNTL flag.
– Default Dilution
– Test Interval
– Time Interval (Minutes)
NOTE: The test interval and the time interval determine the automatic control order
frequency. The configured assay time interval supersedes the configured control level
time interval if both intervals are defined for the same lot number.
21. To enter the onboard stability times for the individual assays, tap Set Stability.
NOTE: If the onboard stability time of an individual assay is less than the onboard stability
time of the control that was entered in step 16, page 351, the assay is disabled for onboard
use from the control. The data row of an assay that is disabled for onboard use is not
highlighted in blue on the Control Create/Edit screen.
The assay cannot be ordered or processed from an onboard vial rack.
Multiconstituent control assays that are disabled for onboard use can be ordered from vials
in a vial rack, from a sample in a sample cup, or from a bar-coded sample tube in a sample
rack when QQQ is added to the beginning of the SID.
For calculated assays, ensure that the onboard stability is configured for the constituent
assays.

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22. To save the edits to the control level settings, tap Save.
To delete the edits to the control level settings, tap Cancel.
23. To add another level, tap a level in the Level drop-down list, type a level name in the Level
Name box, and then repeat steps 20, page 351 through 22, page 353.
NOTE: A maximum of six levels can be configured.
24. To return to the Quality Control screen, tap Done.
Automated control ordering, page 653
Edit a quality control

status
Perform this procedure to edit the settings for a single-constituent control or a multiconstituent
control.
4. Under Control Count on the Quality Control screen, tap a control name.
5. For a multiconstituent control, under Selected Assays, tap one or more individual assays to
include in the control or to remove from the control.
NOTE: For any calculated assays that are added to the control, ensure that the constituent
assays are also added if the control will be stored on the system.
6. Tap View/Edit to display the control data for the default lot number.
NOTE: If an assay was removed from the multiconstituent control, in the confirmation
message that is displayed, tap Yes to confirm the removal. Tap No to retain the assay in the
control.
7. In the Lot drop-down list under Control Configuration on the Control Create/Edit screen,
tap other control lot numbers to display.
8. To configure the selected control lot number as the default, tap the Default check box.

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9. To enter the control expiration date, tap the Expiration Date box.
NOTE: The expiration date cannot be edited if one of the following situations occurred:
– The control lot number has expired.
– The control lot number was created by importing control data.
10. In the Level Name box, type a level name.
NOTE: A level name can have from 1 through 10 characters.
11. In the Automated area, tap Yes or No to indicate whether the system software needs to
evaluate the control periodically and to create orders according to configured time intervals
or test intervals.
12. In the Time Interval (Minutes) box, type the number of minutes to define the frequency to
create an automated order for the control.
NOTE: The Time Interval (Minutes) box is available only if Yes was selected in the
Automated area.
The time interval increases incrementally based on the configured module or control shift
start time.
13. To edit the shift start time for the control, perform one of the following steps:
– Tap the Use Module Shift Time check box.
– Tap to clear the Use Module Shift Time check box. Use the HH:MM format to type a
time in the Start Time box, and then tap AM or PM.
NOTE: The Use Module Shift Time check box and the Start Time box can be edited only if
14. In the Stored Onboard area, tap Yes or No to indicate whether the control can be stored in
NOTE: The Stored Onboard area is available only if Yes was selected in the Automated
area.
This parameter cannot be edited for controls that are currently stored on the system.
Onboard storage capability is available for some multiconstituent controls. To identify
controls that have this capability and the onboard stability time for the control, see the
product documentation.
15. In the Onboard Stability (Hours) box, type the number of hours.
NOTE: This parameter cannot be edited for controls that are currently stored on the system.
16. In the Low Alert Volume (%) box, type the percentage value.
NOTE: The Low Alert Volume (%) box is available only if Yes was selected in the
Automated area.
17. If the in-use stability time is provided, type the number of hours in the In-Use Stability
(Hours) box.

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In-use stability reflects the maximum time that the control can be used on the processing
module without refrigerated storage. A value of zero indicates that in-use stability is not
tracked.
18. To enable or disable one or more assays for the current control level, tap the check box
next to the assay name.
NOTE: Assays that are disabled for a control level are not run when the control level is
ordered.
To disable all the assays for a specific control level, tap the Assay check box. When all the
assays for the control level are disabled, the level is not run when the control is ordered.
When an assay is disabled from a control that is stored on the system, the data row for the
assay is not highlighted in blue. If the assay is enabled and the analyte onboard stability is
greater than or equal to the control onboard stability, the data row is highlighted in blue.
19. Edit the following information for a control assay as necessary:
– Expected 1 SD
– Expected Mean
NOTE: To edit the expected standard deviation and expected mean values, first tap to
clear the Calculate Mean/SD check box for the assay if the check box is selected.
Quality control reports, Levey-Jennings graphs, and quality control summary data are
not generated if the values for Expected 1 SD and Expected Mean are not defined.
Range High box.
High box blank.
Range High box.
Edits to the previously entered control ranges are applied to the Expected Mean and
Expected 1 SD values if the Calculate Mean/SD check box is selected.
To calculate the Expected Mean value, the Expected Range Low value and the
Expected Range High value are added and the sum is divided by two. To calculate the
Expected 1 SD value, the Expected Range Low value is subtracted from the Expected
Range High value and the difference is divided by four.

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The update to the Expected Mean and Expected 1 SD values occurs when the Save
button is selected in step 21, page 356.
– Test Interval
NOTE: The test interval and the time interval determine the automatic control order
frequency. The configured assay time interval supersedes the configured control level
time interval if both intervals are defined for the same lot number.
20. To edit or enter the onboard stability times for the individual assays, perform the following
steps:
a. Tap Set Stability.
b. In the Set Stability flyout, type the number of stability hours.
c. To save the onboard stability setting, tap Done.
To delete the onboard stability setting, tap Cancel.
21. To save the edits to the control level settings, tap Save.
NOTE: If the onboard stability time of an individual assay is less than the onboard stability
time of the control that was entered in step 15, page 354, the assay is disabled for onboard
use from the control. An assay that is disabled for onboard use is not highlighted in blue on
the Control Create/Edit screen. The assay cannot be ordered or processed from an onboard
vial rack. Assays that are disabled for onboard use can be ordered from vials in a vial rack,
from a sample in a sample cup, or from a bar-coded sample tube in a sample rack when
QQQ is added to the beginning of the SID:
– To disable the assay, tap Continue.
– To edit the onboard stability value of the analyte, tap Cancel.
NOTE: If the previously configured value for Expected Mean or Expected 1 SD was edited, a
message is displayed with the option to perform a reevaluation of the control data against
the Westgard rules:
– To reevaluate the control results, tap Continue.
All control results, up to the maximum of 5000 points, for the control lot and level are
recalculated.
– To cancel the reevaluation of the control results, tap Cancel.
22. To edit the assays for another control level, tap a level in the Level drop-down list, and then
repeat steps 18, page 355 through 21, page 356.

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Add an assay to a quality control

status
Perform this procedure to add an assay to a configured multiconstituent control.

5. Tap the name of the assay to add.
6. Tap View/Edit.
7. On the Control Create/Edit screen, tap the check box next to the assay name to enable the
assay for the control level.
8. Enter the following information for the added assay:
– Expected 1 SD
– Expected Mean
NOTE: To calculate automatically the values for Expected 1 SD and Expected Mean
from an entered range, type a value in the Expected Range Low box, type a value in
the Expected Range High box, and then tap the Calculate Mean/SD check box for the
assay.
To calculate the Expected 1 SD value, the Expected Range Low value is subtracted
from the Expected Range High value and the difference is divided by four. To calculate
the Expected Mean value, the Expected Range Low value and the Expected Range
High value are added and the sum is divided by two.
The automatic calculation cannot be performed if a value has been entered in the
Expected 1 SD box or the Expected Mean box.
NOTE: Quality control reports, Levey-Jennings graphs, and quality control summary
data are not generated if the values for Expected 1 SD and Expected Mean are not
defined.

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Range High box.
High box blank.
Range High box.
If neither the Expected Range Low value nor the Expected Range High value is
defined, control results are not evaluated for the application of the CNTL flag.
– Test Interval
NOTE: The test interval and the time interval are available if Yes was selected in the
Automated area. The parameters determine the automatic control order frequency. The
configured assay time interval supersedes the configured control level time interval if
both intervals are defined for the same lot number.
9. To configure an analyte onboard stability if required for a control stored on the system, tap
Set Stability.
10. To save the edits to the control configuration, tap Save.
11. If a confirmation message is displayed, tap OK.
12. To add data for another level, tap a level in the Level drop-down list, and then repeat steps
7, page 357 through 11, page 358.
Delete an assay from a quality control
Prerequisite Ensure that no multiconstituent control orders are pending for

the control to be edited.

status
Perform this procedure to delete an assay from a configured multiconstituent control.

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5. Tap the name of the assay to delete.
6. Tap View/Edit.
7. When a confirmation message is displayed, tap Yes to delete the assay from the control
configuration.
To retain the assay in the quality control and return to the Quality Control screen, tap No.
8. On the Control Create/Edit screen, to save the edits to the control configuration, tap Save.
Delete a quality control lot
Prerequisite Release, archive, and delete the control results that are
associated with the control to be deleted.

status
Perform this procedure to delete a lot number for a configured single-constituent control or a
configured multiconstituent control.
NOTE: Control lot numbers with pending orders or control lot numbers that have vials loaded on
the system cannot be deleted.
Individual control lot numbers are deleted automatically when the following situations occur:
• No pending orders are present for the control lot number.
• The last control data point for the control lot is deleted.


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5. Tap View/Edit to display the control data for the default lot number.
6. In the Lot drop-down list under Control Configuration on the Control Create/Edit screen,
tap other control lot numbers to display.
7. Tap Delete.
To cancel the delete function and return to the Control Create/Edit screen, tap No.
Delete a quality control
Prerequisite Release, archive, and delete the control results that are
associated with the control to be deleted.

status
Perform this procedure to delete a configured single-constituent control or a configured

multiconstituent control.
NOTE: Controls with pending orders or controls that have vials loaded on the system cannot be
deleted.
All the configured lot numbers and the control name are also deleted with the associated quality
control data.
Individual control lot numbers are deleted automatically when the following situations occur:
• No pending orders are present for the control lot number.
• The last control data point for the control lot is deleted.

5. Tap Delete.

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To cancel the delete function and return to the Quality Control screen, tap No.
Release a specimen result or a control result, page 704
Archive the results, page 761
Import quality control data
Required materials One or more quality control data files on a USB flash drive or
on the hard drive
Perform this procedure to import quality control data files to create a new control or to create a
new control lot for a configured multiconstituent control.
NOTE: If a control product has separate c‑series and i‑series data files, both data files must be
imported on the Alinity ci‑series.
If the expected mean and expected standard deviation (1 SD) values are not provided in the
quality control data file, the import process converts manufacturer-provided ranges for these
values.
To calculate the Expected Mean value, the Expected Range Low value and the Expected Range
High value are added and the sum is divided by two. To calculate the Expected 1 SD value, the
Expected Range Low value is subtracted from the Expected Range High value and the
difference is divided by four.
4. Under Control Count on the Quality Control screen, tap a control name or tap New Control.
5. Tap Import.
On the Import screen, the Hard Drive button is selected.
6. In the Quality Control Files list, tap the quality control data file to import.
If the quality control data file is located on a USB flash drive, perform the following steps:
b. Tap the USB Flash Drive button.
c. Tap the appropriate folder.
d. Tap the quality control data file to import.

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NOTE: The assay names and assay numbers for the data in the file and for the
corresponding system assays are displayed with an import status. Data for all quality control
levels is imported for assays that have a status of OK. No data is imported for assays with
the following statuses:
– No Assay
– Previously Defined
– Unit Mismatch
– Version Mismatch
These statuses are displayed in red text.

7. For the selected quality control data file, perform one of the following steps:
– If no data is available to import because of the import status, tap Done to return to the
Quality Control screen and end the procedure.
– To import the data for assays that have a status of OK, tap Import.
8. If New Control was selected in step 4, page 361, under Control Configuration on the
Control Create/Edit screen, type a control name in the Control Name box.
NOTE: A control name can have from 1 through 10 alphanumeric characters.
9. To configure the control lot as the default, tap the Default check box.
NOTE: The first configured lot number is designated automatically as the default lot number
for control orders.
10. To disable an assay for the control level, tap to clear the check box next to the assay name.
NOTE: Assays that are disabled for a control level are not run when the control level is
ordered. All assays for each control level are enabled when a new control is imported.
Disabled and enabled assay statuses are retained when a new control lot number is created
for the control.
11. To save the quality control data file settings, tap Save.
To delete the quality control data file settings, tap Cancel.
12. To edit the assays for another level, tap a level in the Level drop-down list, and then repeat
steps 10, page 362 and 11, page 362.
14. If a USB flash drive was inserted, remove the USB flash drive.
Quality control data files that are imported from a USB flash drive are saved to an internal
storage location on the system. To reinstall the quality control data files on a future date, tap the
Hard Drive button.

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Delete imported quality control data
Perform this procedure to delete quality control data files from the user interface computer. After
a quality control data file is deleted, the file is unavailable to be reinstalled.
NOTE: This procedure cannot be used to delete quality control data files from a USB flash drive.
5. Tap Import.
On the Import screen, the Hard Drive button is selected.
6. In the Quality Control Files list, tap the quality control data file to delete.
7. Tap Delete.
8. To delete the quality control data file, tap Continue.
To cancel the delete function, tap Cancel.
9. To return to the list of control names on the Quality Control screen, tap Done.
View or print a quality control insert
Perform this procedure to view or print a quality control (QC) insert or to save the insert as a
portable document format (PDF) file.
NOTE: A QC insert is available only for selected quality control products and only for control lot
numbers that were created from an imported file and have not been deleted previously on the
hard drive.

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5. Tap View/Edit to display the quality control data for the default lot number.
6. In the Lot drop-down list under Control Configuration, tap a control lot number that is not
the default.
7. Tap Print.
8. Under Report Selection in the Print flyout, tap Control Insert.
d. Tap OK.
17. To return to Control Configuration on the Control Create/Edit screen, tap Done.
Descriptions of quality control import statuses

Quality control import status information is used to resolve issues that occur when quality control
data is imported. The system displays one quality control import status for each assay on the
Import Controls screen.
The following list provides descriptions of the quality control import statuses:
OK The imported assay has the same assay number and result
units as the assay that was configured on the system. The
data is imported.

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No Assay No assay on the system has the same assay number in the
imported file. The data is not imported.
Previously Defined The data has been manually entered or imported. The data is
not imported.
Unit Mismatch The imported assay has a different value in the Unified Code
for Units of Measure (UCUM) area than the system assay
with the same assay number. The data is not imported.
Version Mismatch The imported assay has the same assay number as the assay
that was configured on the system, but the imported assay
does not have the same assay version as the configured
assay. The data is not imported.
Westgard screen
On the Westgard screen, the operator can view the Westgard rule settings for each assay
The supervisor or system administrator can configure Westgard rule settings for each assay
Configure Westgard rules, page 366
Westgard screen element descriptions

The Westgard screen displays the Westgard rule configuration settings for the assays installed
on the system.
Rule Configuration area
Rule Name Displays a list of the Westgard rules that are available for
each assay.
Enable Displays a check box that is used to enable the corresponding

rule for Westgard analysis for the assay.
Rule Settings Displays the following options that are used to configure the
corresponding rule for Westgard analysis:

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Warning Assay results generated after a control

result meets the criteria of a rule that is
configured as a warning are not
flagged with the CNTL flag.
Failure Assay results generated after a control

result meets the criteria of a rule that is
configured as a failure are flagged with
the CNTL flag.
Function buttons


Save Saves changes.
Westgard rule descriptions, page 730
Configure Westgard rules

status
Perform this procedure to configure Westgard rules, which are used to assess quality control
results.
3. On the Assay tab of the Configure screen, tap Westgard.
4. Under Assays on the Westgard screen, tap an assay to configure.

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5. Under Rule Name, tap one or more rules to enable.

6. Under Rule Settings, tap Warning or Failure for each rule that is enabled.
7. To save the edits to the rule settings, tap Save.
To delete the edits to the rule settings, tap Cancel.
Westgard rule application, page 729
Configure screen, Maintenance & Diagnostics tab

The operator can perform the following tasks from the Maintenance & Diagnostics tab of the
Configure screen:
Install/Uninstall M&Ds • Install new or revised maintenance and diagnostic
procedure files.
• Uninstall maintenance and diagnostic procedures files.
User-Defined • Create or edit a user-defined maintenance procedure file.

Maintenance
• Import or export a user-defined maintenance procedure
file.
• Print a list of the user-defined maintenance procedures
with a description of each procedure.
User-Defined Maintenance screen, page 372
Install/Uninstall Procedures screen

On the Install/Uninstall Procedures screen, the system administrator can perform the following
functions:
• Install maintenance and diagnostic procedures.
• Uninstall maintenance and diagnostic procedures.

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Install procedure files, page 371

Uninstall procedure files, page 371
Install/Uninstall Procedures screen, Available Files tab element descriptions

The Available Files tab displays all procedure files that are available for installation on the
system or on a USB flash drive.
Elements
Displaying Procedure Displays the file folder hierarchy that contains the procedure
Files in files displayed in the Procedure list.

selected folder.
Procedure Displays the number and name of the selected procedure.
Type Displays the type of the selected procedure. The Available

Files tab has two procedure types:
• Maintenance
• Diagnostics
Update Status Displays the status of all procedure files that are available.
The Available Files tab has five file statuses:
• Current
• New
• Update
• Installed
• Previous

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Function buttons

Install Installs the selected files on the current screen.
Install/Uninstall Procedures screen, Installed Files tab element descriptions

The Installed Files tab displays all procedure files that are installed on the system.
Elements
Procedure Displays the number and name of the installed procedure.
Version Displays the version of the procedure.
Type Displays the type of the selected procedure. The Installed

Files tab has two procedure types:
• Maintenance
• Diagnostics
Category Displays the category for the procedure. The Installed Files
tab has the following categories.
The following categories are displayed for maintenance
procedures:
• Daily
• Weekly

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• Monthly
• Quarterly
• Triannual
• Semiyearly
• Yearly
• As Needed
The following categories are displayed for diagnostic

procedures:
• Optics
• Pipettors
• Fluidics-Wash
• Temperature
• RV Loader (only for i‑series)
• Process Path (only for i‑series)
• Sample Manager
• Reagent Manager
• Modules
• Utilities
• Reaction Mechanisms (only for c‑series)
• ICT (only for c‑series)
Function buttons


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Install procedure files

status
Perform this procedure to install maintenance and diagnostics procedure files.

2. On the Configure screen, tap the Maintenance & Diagnostics tab.
3. On the Maintenance & Diagnostics tab of the Configure screen, tap Install/Uninstall
M&Ds.
On the Available Files tab of the Install/Uninstall Procedures screen, the Hard Drive button
is selected.
4. Under Procedure on the Available Files tab, tap one or more procedure files to install (or
tap Select All).
5. Tap Install.
Export a user-defined maintenance procedure, page 378
Uninstall procedure files

status
Perform this procedure to uninstall maintenance and diagnostic procedure files. Uninstalled
procedure files are listed in the procedure log with a history of previous actions. Procedure files
remain available to be reinstalled from the Available Files tab of the Install/Uninstall Procedures
screen.

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3. On the Maintenance & Diagnostics tab of the Configure screen, tap Install/Uninstall
Procedures.
4. On the Install/Uninstall Procedures screen, tap the Installed Files tab.
5. On the Installed Files tab, tap one or more procedure files to uninstall (or tap Select All).
6. Tap Uninstall.
User-Defined Maintenance screen

On the User-Defined Maintenance screen, the supervisor or the system administrator can
perform the following functions:
• Create a text-based maintenance procedure.
• Print a procedure.
• Uninstall a procedure.
• Export a procedure.
User-Defined Maintenance screen, Export tab element descriptions, page 374
Create a user-defined maintenance procedure, page 375
Edit a user-defined maintenance procedure, page 376
Uninstall a user-defined maintenance procedure, page 377
User-Defined Maintenance screen, Create/Edit tab element descriptions

The Create/Edit tab displays the user-defined procedures that are editable and allows the
operator to create new user-defined procedures.
Elements
Installed User-Defined Displays the procedure numbers and names of installed

Maintenance procedures.
Procedures

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Operator ID Displays the identification of the operator logged onto the

system when the procedure was created or edited. When a
new procedure is created, this element is blank.
Date/Time Displays the date and time that the procedure was created or
edited. When a new procedure is created, this element is
blank.
Number Displays the number of the procedure. The user-defined

procedure number can be any number from 3950 through
3999.
When a new procedure is created, the next available
procedure number is displayed. After the procedure is created
and saved, this element is not editable.
Version Displays the version of the procedure. When a new procedure

is created, the version is defined as 1. After the procedure is
edited and saved, the version number increases incrementally.
Name Displays the name of the procedure. The procedure name can
have from 1 through 65 characters. After the procedure is
created and saved, this element is not editable.
Frequency Displays a drop-down list that is used to select the frequency

of the procedure:
• Daily
• Weekly
• Monthly
• Quarterly
• Triannual
• Semiyearly
• Yearly
• As Needed
Module Displays the required module type for the procedure. The
following module type options are displayed:
• RSM
• i-series
• c-series

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After the procedure is created and saved, this element is not

editable.
Description Displays a brief procedure description. The description can

have from 1 through 125 characters. When a new procedure
is created, this element is blank.
Instructions Displays the procedure instructions. The instructions can have

from 1 through 5500 characters. When a new procedure is
created, this element is blank.
Function buttons

Cancel Displays a message requesting confirmation to cancel

selections or entries.
Save Saves changes.

Print a report, page 755
User-Defined Maintenance screen, Export tab element descriptions

The Export tab displays all user-defined maintenance procedures that are available for export.
Elements
Status Displays the status of the file export.

selected folder.

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Procedure Displays the number and name of the procedure.
Version Displays the version of the procedure.
Category Displays the category for the procedure. The Export tab has
the following categories.
• Daily
• Weekly
• Monthly
• Quarterly
• Triannual
• Semiyearly
• Yearly
• As Needed
Function buttons

Export Exports the select files from the user interface computer to
the USB flash drive.
Create a user-defined maintenance procedure

status

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Operator access level Supervisor and system administrator
Perform this procedure to create a user-defined, text-based maintenance procedure.

3. On the Maintenance & Diagnostics tab of the Configure screen, tap User-Defined
Maintenance.
4. On the Create/Edit tab of the User-Defined Maintenance screen, if a procedure number
other than the number that is displayed is needed, type a number from 3950 through 3999.
5. Type the name of the procedure.
6. Tap the time interval in the Frequency drop-down list.
7. Tap the Module button for which the procedure is intended.
8. Type a brief procedure description that is displayed on the Procedures screen with the
procedure number and name.
9. Type the procedure instructions.
10. To save the procedure, tap Save.
To delete the procedure, tap Cancel.
11. To create another procedure, repeat steps 4, page 376 through 10, page 376.
Edit a user-defined maintenance procedure, page 376
Edit a user-defined maintenance procedure

status
Perform this procedure to edit a user-defined maintenance procedure.


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Maintenance.
4. On the Create/Edit tab of the User-Defined Maintenance screen, under Installed User-
Defined Maintenance Procedures, tap the procedure to edit.
5. Edit any or all of the following information:
– Frequency
– Description
– Instructions
6. To save the edits to the procedure, tap Save.
To delete the edits to the procedure, tap Cancel.
7. To edit another procedure, repeat steps 4, page 377 through 6, page 377.
Create a user-defined maintenance procedure, page 375
Uninstall a user-defined maintenance procedure

status
Perform this procedure to uninstall user-defined maintenance procedure files. Uninstalled

procedure files are listed in the procedure log with a history of previous actions. Procedure files
remain available to be reinstalled from the Available Files tab of the Install/Uninstall Procedures
screen.
NOTE: If a user-defined maintenance procedure file is uninstalled, the procedure number can be
reused and the new information overwrites the previous information. If a new procedure name is
assigned to a reused procedure number, the previous procedure name remains in the procedure
log for the previous months. However, the new procedure name is displayed for the current
month.
Maintenance.

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4. On the Create/Edit tab of the User-Defined Maintenance screen, under Installed User-
Defined Maintenance Procedures, tap one or more procedure files to uninstall.
5. Tap Uninstall.
Export a user-defined maintenance procedure

status
Perform this procedure to export user-defined maintenance procedure files to a USB flash drive.
After the procedure files are exported, the files can be installed from the USB flash drive to a
different system.
Maintenance.
5. On the User-Defined Maintenance screen, tap the Export tab.
6. On the Export tab, tap the USB flash drive to which to export the procedure files.
7. Tap one or more procedure files to export (or tap Select All).
8. Tap Export.

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Section 2 Utilities screen
Utilities screen
The operator can perform the following tasks from the Utilities screen:
Backup/Restore • Perform a backup.
• Copy a backup to a USB flash drive.
System Updates • Download system updates.

• Install and verify system updates.
• Decline nonmandatory system updates.
Troubleshooting Retrieve system log packages.
Current Firmware View the current firmware.
Licenses View or print the Licenses Report.
Backup/Restore screen, page 379
System Updates screen, page 384
Troubleshooting screen, page 395
Current Software screen, page 397
Current Firmware screen, page 398
View or print the Licenses Report, page 399
Backup/Restore screen
On the Backup/Restore screen, the operator can view a list of previously created backups.
The operator can perform the following functions:
• Perform a backup.
• Copy a backup to a USB flash drive.
Backup/Restore screen element descriptions, page 380
Copy Backup flyout element descriptions, page 381
Backup flyout element descriptions, page 381
Perform a manual backup, page 382

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Utilities screen Section 2
Copy a backup to a USB flash drive, page 383
Backup/Restore screen element descriptions

On the Backup/Restore screen, the operator can create a manual backup.
Elements
Displaying Backup Displays the currently selected drive and folder.

Files In
selected folder.
Date/Time Displays the date and time that the backup was generated.
Type Displays the type of backup. Three backup types are available
on the Backup/Restore screen:
• Daily (automatic backup)
• Weekly (automatic backup)
• Manual
Version Displays the system software version at the time that the
backup was generated.
Comment Displays the comment entered when the backup was

generated. A comment is displayed only for manual backups.
Function buttons
Utilities Displays the Utilities screen.
Create Backup Displays the Backup flyout.
Copy Displays the Copy Backup flyout.

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Copy Backup flyout element descriptions

The Copy Backup flyout displays the drive and folders that are used to save a backup copy.
Elements

selected folder.
Last Update Displays the date and time that the files in the folder were
most recently updated.
Function buttons



Backup flyout element descriptions

In the Backup flyout, the operator can enter a comment.
Element
Comment Displays a text box that is used to enter a comment for a

backup. The comment can contain a maximum of 100
characters.

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Function buttons



Perform a manual backup
Required materials A USB flash drive is required only if a copy of a backup is

saved to the USB flash drive.
Required instrument Any status except Processing and Pausing

status
Perform this procedure after a software update is downloaded, a new assay file is downloaded,
or the system configuration is changed. The last three manual backups are saved on the hard
drive.
The following items are saved in the backup:
• System calibration data (for example, robotics data and optics data)
• User-defined maintenance procedures
• The system database, which includes the following items:
– System configuration settings (for example, host settings, report settings, system serial
number, and system name)
– Reagent cartridge test counts
– Assay configuration settings
– Assay calibration data
– Control configuration
– Control results
– Specimen results
– Installed maintenance and diagnostic procedures and the maintenance and diagnostic
procedure history
– Supply data

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– Assay inserts
– Abbott Mail items
– System updates
1. On the menu bar, tap System, and then tap Utilities.

2. On the Utilities screen, tap Backup/Restore.
3. On the Backup/Restore screen, tap Create Backup to save a backup on the hard drive.
To save a backup on the hard drive and a copy of the backup on a USB flash drive, perform
the following steps:
b. Tap the appropriate USB flash drive and folder.
c. Tap Create Backup.
4. In the Comment box in the Backup flyout, type the reason that the manual backup was
performed, and then tap Done.
5. If the USB flash drive was inserted, remove the USB flash drive.
Copy a backup to a USB flash drive
Perform this procedure to copy a backup from the system to a USB flash drive.
3. On the Utilities screen, tap Backup/Restore.
4. On the Backup/Restore screen, tap a backup to copy.
5. Tap Copy.
6. In the Copy Backup flyout, tap the USB flash drive and folder to which to copy the backup.
7. To copy the backup, tap Done.
To cancel the copy function, tap Cancel.
9. To return to the Utilities screen, tap Utilities.

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System Updates screen

An Abbott Laboratories representative installs the Alinity ci‑series and the system software. After
the system is running, occasional software and hardware updates may be received that need to
be installed manually. System updates are distributed as technical service bulletins (TSBs) and
can be downloaded from the Abbott Mail screen. The system administrator can install simple
TSBs. The Abbott Laboratories representative needs to install more difficult TSBs. All TSBs are
tracked on the System Updates screen.
On the System Updates screen, the operator can view system updates and system update
documentation.
The operator can print system update documentation.
• Download software updates.
• Install and verify system updates.
• Decline nonmandatory system updates.
Comments flyout element descriptions, page 388
System Update Import screen element descriptions, page 388
Descriptions of system update statuses, page 389
View or print system update documentation, page 390
Download the system update software, page 391
Install a system update, page 391
Decline a system update, page 392
Manually verify a system update, page 392
Add a comment to a system update, page 393
Set a declined system update as available for installation, page 393
System Updates screen element descriptions

The System Updates screen displays system updates that are available for installation, system
updates that are installed, and system updates that have been declined by the operator.

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Elements
TSB Number Displays the technical service bulletin (TSB) number. System
updates are distributed as TSBs.
Module SN Displays the serial number of the module associated with the
TSB.
Status Displays the status of each system update. The System

Updates screen has 11 system update statuses:
• Available
• Download Requested
• Download Failed
• Ready to Install
• Install in Progress
• Install Failed
• Pending Verification
• Applied
• Manually Applied
• Superseded
• Ignored
Date Displays the date of the current status for the TSB.
Details area
TSB Number Displays the TSB number. System updates are distributed as
TSBs.
Product Code Displays a list of product codes that apply to the TSB that is
displayed. The following product codes are available:
• 205 (Alinity i)
• 210 (Alinity c)
• 214 (system control module)
Mandatory Displays if the system update is mandatory and must be

installed.

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Requires System Displays if the software needs to be restarted after the TSB is
Restart installed.
Install Access Level Displays the minimum access level that is necessary to install
the TSB. The System Updates screen has five access levels:
• General
• Supervisor
• Administrator
• CSC
NOTE: This access level requires Abbott Customer
Service authorization.
• FSE
NOTE: This access level requires field service
installation.
Requires Verification Displays if the TSB requires a manual verification after the
installation is completed. If the TSB requires a manual
verification, the System Update Letter for the TSB provides
instructions and can be printed.
Prerequisite Update Displays a list of TSB numbers that must be installed before
the TSB that is displayed is installed.
Superseded Updates Displays a list of TSB numbers that are outdated by the
installation of the TSB that is displayed.
Description Displays a short description of the TSB. For more information,
the System Update Letter can be printed.
Activity Log area
Timestamp Displays the date and time of the current status for the TSB.
Status Displays the current status of the TSB. The System Updates
screen has 11 system update statuses:
• Available
• Download Failed

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• Install Failed
• Applied
• Superseded
• Ignored

system when the status was updated for the TSB.
Function buttons
Import Imports the selected file.
Set as Available Sets the system update status of the TSB to Available. This
function button is located on the Installed Updates tab and
the Declined Updates tab.
Install Failed Sets the system update status of the TSB to Install Failed.
This function button is located on the Installed Updates tab.
Download Requests a system software installer to be downloaded. This

function button is located on the Available Files tab.
Install Installs the selected TSB. This function button is located on

the Available Files tab.
Decline Sets the system update status of the TSB to Ignored and
moves the TSB to the Declined Updates tab. This function
button is located on the Available Files tab.
Verify Sets the system update status of the TSB to Manually

Applied. This function button is located on the Available Files
tab.
Change Status Displays the Status Change flyout. The Status drop-down list
has two change statuses:

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Comments Displays the Comments flyout.
Comments flyout element descriptions

In the Comments flyout, the operator can enter a comment.
Element
Comments Displays a text box that is used to enter a comment for the
system update.
Function buttons


Clear Removes text from the comment box without closing the
flyout.

System Update Import screen element descriptions

On the System Update Import screen, the operator can import a translated version of the
operations manual.

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Elements

selected folder.
File Name Displays the name of the system update file.
File Date And Time Displays the date and time of the system update file.
Import File Displays the file location and file name of the selected system
update file.
Function buttons

Import Imports the selected file.
Descriptions of system update statuses

System update status information is used to determine the status of each system update.
The following list provides descriptions of the system update statuses. When the Status column
header is selected, the system update statuses sort alphabetically in ascending order:
Available The software installer for a system update is available to

download.
Download Requested A request to download the system software installer is in

process.

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Download Failed An error occurred and the request was not completed.
Ready to Install The system software installer is present and is ready to

install.
Install in Progress The installation is in process.
Install Failed An error occurred and the installation was not completed.
Pending Verification The installation of the system update was successful, but a
manual verification by the operator is required.
Applied The installation of the system update is completed.
Manually Applied The system update was completed after a manual verification
or by an Abbott Laboratories representative.
Superseded The system update was superseded by a different system

update.
Ignored The system update was declined and was not installed.
System Update Details Report element descriptions, page 1693
System Update List Report element descriptions, page 1696
View or print system update documentation

Perform this procedure to view or print system update documentation.
2. On the Utilities screen, tap System Updates.
3. On the Available Files tab of the System Updates screen, tap a technical service bulletin
(TSB) number in the TSB list.
4. Tap Print.
5. Under Report Selection in the Print flyout, tap System Update Letter.
9. To resize the document to fit the window width ( ) or to resize the document to fit one full
page in the window ( ), use the Fit toolbar.

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11. To print the document, tap Print.
To return to the System Updates screen, tap Done.
Download the system update software
System update status Available or Download Failed
Operator access level The access level depends on the system update.
Perform this procedure to download the software installer for a new system update or a previous
software installer download that failed. After the software installer is downloaded, the system
update is ready for installation.
4. Tap Download.
Install a system update, page 391
Install a system update
System update status Ready to Install

status
Perform this procedure to install a system update.

4. Tap Install.

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Download the system update software, page 391
Decline a system update
System update status Ready to Install or Available
Operator access level The access level depends on the system update. Mandatory
system updates can be declined only by an Abbott
Laboratories representative.
Perform this procedure to decline a system update. After the system update is declined, the
update is moved to the Declined Updates tab. System updates that have been declined can be
set as available for installation if necessary.
4. Tap Decline.
5. In the Comment box, type the reason that the TSB needs to be declined.
NOTE: Additional comments can be added to a TSB record. To maintain the traceability of
the comments, include a date and an operator ID with each comment.
6. To decline the TSB, tap Done.
To return to the TSB list without declining the TSB, tap Cancel.
Set a declined system update as available for installation, page 393
Manually verify a system update
System update status Pending Verification
Perform this procedure when a software system update requires a manual verification.

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4. Tap Verify.
Add a comment to a system update

Perform this procedure to add a comment to a system update.
3. To add a comment to an available update, a declined update, or an installed update, tap the
appropriate tab on the System Updates screen.
4. On the appropriate tab of the System Updates screen, tap a technical service bulletin (TSB)
number in the TSB list.
5. Tap Comments.
6. In the Comments flyout, type the information that is associated with the update.
7. To save the comment, tap Done.
To delete the comment, tap Cancel.
To clear the entered comments, tap Clear.
Set a declined system update as available for installation
System update status Declined
Perform this procedure to change the status of a system update from Declined to Available and
to allow a declined update to be set as available for installation.

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3. On the System Updates screen, tap the Declined Updates tab.
4. On the Declined Updates tab of the System Updates screen, tap a technical service bulletin
5. Tap Set As Available.
6. In the Comment box, type the reason that the TSB needs to be set as available for
installation.
7. To save the change to the TSB status, tap Done.
To return to the TSB list without changing the TSB status, tap Cancel.
Decline a system update, page 392
Import a translated version of the operations manual
Perform this procedure to import a translated version of the operations manual (online help).
After the translated operations manual is imported, the appropriate language can be selected in
the Online Help Language drop-down list on the Configuration screen, Computer tab, General
Settings screen.
1. Insert a USB flash drive that contains the system update.
4. On the Available Files tab of the System Updates screen, tap Import.
5. Tap the appropriate USB flash drive and folder that contain the system update.
6. Under File Name, tap the system update name in the list of updates.
7. Tap Import.
9. When a system update import message is displayed, tap OK.

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Cycle power to the system, page 480
Troubleshooting screen
On the Troubleshooting screen, the operator can retrieve system log packages that can be used
for troubleshooting by an Abbott Laboratories representative.
Descriptions of troubleshooting packages, page 396
Retrieve a troubleshooting package, page 396
Troubleshooting screen element descriptions

System logs are used primarily to troubleshoot instrument problems and to gather data about an
instrument operation. All troubleshooting packages can be retrieved when the instrument status
is Idle.
Troubleshooting Data area
Troubleshooting Displays a list of the troubleshooting packages that are

Packages available.
Function buttons
Utilities Navigates to the Utilities screen.
Retrieve AbbottLink Used to send the troubleshooting package to AbbottLink.
Retrieve Removable Used to save the troubleshooting package to a USB flash

Media drive.
Descriptions of troubleshooting packages, page 396

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Descriptions of troubleshooting packages

Troubleshooting package information contains system logs and data that is used by an Abbott
Laboratories representative to troubleshoot instrument and assay issues.
The following list provides descriptions of the troubleshooting packages:
Core Operational Data Includes core operational data (for example, result data,
calibration data, and instrument operational data) that is
located in the operational data recorder (ODR) of the
instrument.
Instrument Logs Includes instrument logs.
External Includes all communication logs with external systems (for

Communication Logs example, HL7 and ASTM host communication logs).
Retrieve a troubleshooting package

status
Required materials A USB flash drive is required only if a troubleshooting
package is saved to the USB flash drive.
Perform this procedure to retrieve a troubleshooting package that can be used for
troubleshooting by an Abbott Laboratories representative.
2. On the Utilities screen, tap Troubleshooting.
3. Under Troubleshooting Packages on the Troubleshooting screen, tap a package to
retrieve.
4. To send the troubleshooting package to AbbottLink, tap Retrieve AbbottLink.
To save the troubleshooting package on a USB flash drive, tap Retrieve Removable Media,
and then perform the following steps:
b. In the Retrieve to Removable Media flyout, tap the appropriate USB flash drive and
folder.
c. To save the troubleshooting package, tap Done.
To cancel the save function, tap Cancel.

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d. Remove the USB flash drive.

Current Software screen

On the Current Software screen, the operator can view the current software version information.
Current Software screen element descriptions, page 397
Current Software screen element descriptions

On the Current Software screen, the operator can view the current software version information.
Elements
Module ID The module identification is blank for the system software

located on the system control module.
Component Name Displays the name of the software component.
Version Number Displays the version number of the software component.
Build Date/Time Displays the date and time that the software was created.
Refresh Date/Time Displays the date and time that the software version
information was obtained.
Unique Identifier Displays the list number of the software version.
Part Number Displays the part number of the software version.
Function buttons

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Current Software screen, page 397
Current Firmware screen

On the Current Firmware screen, the operator can view the i‑series processing module firmware,
the reagent and sample manager firmware, and the pressure monitor board firmware for the
c‑series processing module when requested by an Abbott Laboratories representative.
Current Firmware screen element descriptions, page 398
Current Firmware screen element descriptions

The Current Firmware screen displays the firmware for the i‑series processing module and the
reagent and sample manager (RSM).
Elements
Module ID Displays the number of the processing module or the RSM.
Device Name Displays the name of the device.
Version Number Displays the version number of the firmware.
Build Date/Time Displays the date and time that the firmware was created. If
the firmware version information is unavailable because of a
device communication failure, dashes are displayed.
NOTE: The build date and time are not applicable to the bar
code reader, servo controller boards, and the PHM data
board.
Refresh Date/Time Displays the date and time that the version information was
obtained. If the firmware version information is unavailable
because of a device communication failure, dashes are
displayed.
Function buttons

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Current Firmware screen, page 398
View or print the Licenses Report

Perform this procedure to view or print the Licenses Report.

2. On the Utilities screen, tap Licenses.
3. Under Report Selection in the Print flyout, tap Licenses.
d. Tap OK.
12. To return to the Utilities screen, tap Done.
Print flyout, page 751

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NOTES

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Section 3 Principles of operation
Introduction
The Alinity ci‑series uses photometric, potentiometric, and chemiluminescent microparticle
immunoassay (CMIA) detection technologies to measure analyte concentrations in samples.
Principles of operation (c‑series), page 402
Principles of operation (i‑series), page 428

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Principles of operation
Principles of operation (c‑series) Section 3
Principles of operation (c‑series)

Principles of operation for the c‑series provide an overview of photometric and potentiometric
detection technologies, the assay processing, and the SmartWash feature used for analyte
measurement. The principles also include an overview of sample interference indices for lipemic,
hemolyzed, and icteric samples.
Principles of operation, page 401
Photometric method (c‑series), page 402
Potentiometric method (c‑series), page 408
Assay processing (c‑series), page 414
Indirect assay processing method (c‑series), page 423
Optimum sampling sequence feature (c‑series), page 424
Sample interference indices (c‑series), page 425
Photometric method (c‑series)

The c‑series uses the photometric detection technology to measure sample absorbance for the
quantitation of analyte concentration.
Photometric technology (c‑series), page 402
Optical measurement (c‑series), page 405
Photometric technology (c‑series)

Photometric technology is the measurement of the amount of light that a sample absorbs. A
beam of light is passed through a sample and the intensity of light that reaches a detector is
measured. Beer's Law establishes the mathematical relationship between the absorbance of the
solution and the concentration of the analyte. The absorbance of the solution changes as the
reaction progresses. Measurements occur either when all the reactant is depleted and the
reaction is stable (end-point assays) or when the reactant reaches a stable rate (rate assays).
End-point assay reactions (c‑series), page 403
Rate assay reactions (c‑series), page 404

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Section 3 Principles of operation (c‑series)
End-point assay reactions (c‑series)

End-point assay reactions proceed until all reactant is depleted and the absorbance is stable.
When the reaction is completed, the system measures the absorbance readings used for
calibration and to calculate results.
For end-point assays, the system calculates the concentration by using the absorbance data
obtained during the main read time specified on the General tab of the Assay Parameters
screen.
The following illustration shows a typical end-point assay reaction curve.
Figure 101: Example of an end-point assay reaction curve (c‑series)
Where:
Abs Absorbance
T Time measured in photometric read points
SD Sample dispense
FRD First reagent dispense
SRD Second reagent dispense
M Main read time

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page 1543
Rate assay reactions (c‑series)

Rate assay reactions reach a stable rate in which the change in absorbance between readings is
constant. The system performs several readings during this time, calculates the change of
absorbance per minute (rate), and then uses the rate to calculate results.
For rate assays, the system uses the linear least squares method to calculate the change of
absorbance per minute (Δ Abs/min) during the main read time specified on the General tab of
the Assay Parameters screen. The calculation must include a minimum of three photometric
points to receive a result without a flag. The maximum number of photometric points is 38.
The following illustration shows a typical rate assay reaction curve.
Figure 102: Example of a rate down assay reaction curve (c‑series)
Where:
Abs Absorbance
SD Sample dispense
FRD First reagent dispense
SRD Second reagent dispense
M Main read time

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ABL Lower limit of the absorbance range
page 1543
FlexRate method and absorbance range (c‑series photometric), page 1578
Optical measurement (c‑series)

The c‑series uses an optical measurement to obtain absorbance readings and then converts
them to assay-specific analyte concentration units or assay-specific qualitative interpretations.
Optical system and measurement sequence (c‑series), page 405
Data reduction calculation (c‑series photometric), page 407
Optical system and measurement sequence (c‑series)

The optical system on the processing module is a direct photometry system that directs and
aligns the light from the source lamp, through the water bath and the cuvette, to the optics unit.
The optical system directs and aligns only the light that originates from the source lamp and
simultaneously measures the intensity of 16 different wavelengths.

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Figure 103: Optical system (c‑series)
Legend:
1. Preamp board
2. Linear photodiode array
3. Diffraction grating
4. Entrance slit
5. Convex lens
6. Water bath lens
7. Cuvette
8. Heat glass
9. Lamp
10. Data acquisition (DAQ) board
11. Central processing unit (CPU) board
The measurement sequence occurs as the optical system performs the following actions:
1. A convex lens focuses the light from a tungsten halogen lamp and passes the light through
the cuvette to measure absorbance changes as the reaction progresses.

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2. A second convex lens focuses the light through the entrance slit onto the diffraction grating.
3. The diffraction grating separates the focused light beam into 16 component wavelengths
(340 nm to 804 nm) and reflects the light spectrum onto the photodiode array.
4. The photodiode array measures the light intensity at the different wavelengths.
5. The preamp board, the DAQ board, and the CPU board convert and amplify the signal from
the photodiode array and then communicate transmittance values to the user interface
computer where data reduction and result calculation occur.
Data reduction calculation (c‑series photometric)

The data reduction calculation is used to calculate final absorbance values and the result
concentration.
The system control module (SCM) receives transmittance readings from the processing module
for each cuvette, determines the readings that are necessary to calculate the result, and then
converts these readings to absorbance values. The system uses readings from one wavelength
(monochromatic) or two wavelengths (bichromatic) to calculate assay results. Most assays are
bichromatic.
Number of wavelengths measured at How the absorbance values are calculated
each read point
1 - Monochromatic Uses the reading from one wavelength
2 - Bichromatic Subtracts the readings that occur at the secondary wavelength
from the readings that occur at the primary wavelength and
uses the difference as the absorbance value
The reaction mode and the number of read points in the reading window determine which
absorbance values are used in the result calculation as shown in the following table.
Reaction mode Photometric points Absorbance values used for result calculation
in read time
End Up, End Down 1 The absorbance value that corresponds to the specified point.
2 The average of the two absorbance values.
3 The maximum and minimum values are excluded and the
remaining value is used for calculation.
>3 The maximum and minimum values are excluded and the
average of the remaining values is used for calculation.
Rate Up, Rate Down N The absorbance values for all defined photometric read points
(N) are used to calculate the change in absorbance per
minute for the reaction.
NOTE: The system adjusts the absorbance data readings to light path length values of 10 mm.

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The absorbance data readings are blank corrected, as specified for each test, and then are
converted to concentration units.
page 1543
Color correction (c‑series photometric), page 1574
Potentiometric method (c‑series)

The c‑series uses the potentiometric detection technology to measure the electrical potential in
a sample. In addition, the c‑series uses an integrated chip technology (ICT) module to measure
potentiometric assays (electrolytes).
Integrated chip technology (c‑series), page 408
ICT measurement (c‑series), page 409
Integrated chip technology (c‑series)

Integrated chip technology (ICT) is the method that the c‑series uses to simultaneously measure
sodium, potassium, and chloride. ICT methodology uses solid-state, ion-selective electrodes that
are contained in one chip (ICT module), which reduces the maintenance that is necessary to
perform electrolyte measurements.
The ICT module contains the following electrodes:
Sodium (Na+) A crown ether ionophore that is incorporated into an ion-

selective plastic membrane. (Because the electrode does not
use a glass membrane, it is less affected by sample pH
changes.)
Potassium (K+) Valinomycin that is incorporated into an ion-selective plastic

membrane.
Chloride (Cl-) A solid silver chloride (AgCl) disk.
Reference A silver-silver chloride electrode in a potassium chloride (KCl)

gel inner solution that is separated from the sample by a
porous ceramic tube.

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ICT measurement (c‑series)

The c‑series uses ICT measurement to obtain millivolt readings and then converts them to
assay-specific analyte conversion units. The measurements of ICT Reference Solution and ICT
samples are used to calculate assay results.
ICT Reference Solution and sample delivery and processing (c‑series), page 409
Measurement by the ICT module (c‑series), page 412
Data reduction calculation (c‑series potentiometric), page 413
ICT Reference Solution and sample delivery and processing (c‑series)

ICT Reference Solution and ICT samples are delivered to the ICT module where measurements
occur.
Figure 104: ICT Reference Solution delivery (c‑series)

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During ICT Reference Solution delivery and processing, the ICT Reference Solution cup is filled
with the ICT Reference Solution, which is analyzed, and then the waste is removed:
1. The syringe on the left side of the ICT Reference Solution pump moves the ICT Reference
Solution from the bottle, through the warming ring, and into the ICT Reference Solution cup.
2. The ICT unit moves down to position the ICT probe in the ICT Reference Solution cup.
3. The syringe on the right side of the ICT aspiration pump aspirates the ICT Reference
Solution from the cup into the ICT module.
4. The ICT module measures the ICT Reference Solution. The system converts the
measurements into millivolt readings that are used for reference when sample result
concentrations are calculated.
5. High-concentration waste processing begins:
The syringe on the right side of the ICT aspiration pump moves the ICT Reference Solution
from the ICT module to the high-concentration waste compartment.
6. The syringe on the left side of the ICT aspiration pump moves the liquid waste from the
high-concentration waste compartment.
7. The syringe on the left side of the ICT aspiration pump moves the liquid waste to the high-
8. Low-concentration waste processing begins:
The syringe on the right side of the ICT Reference Solution pump moves the remaining ICT
Reference Solution from the ICT Reference Solution cup.
9. The syringe on the right side of the ICT Reference Solution pump moves the solution to the
low-concentration waste compartment in the water bath overflow and waste area.
10. Gravity causes the liquid waste to drain from the low-concentration waste compartment in
the water bath overflow and waste area to the low-concentration waste tubing.

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Figure 105: ICT sample delivery (c‑series)
During ICT sample delivery and processing, the sample and the ICT Sample Diluent are
dispensed, the sample is analyzed, and then the waste is removed:
1. The sample pipettor dispenses 15 μL of sample into a cuvette.
2. Reagent pipettor 1 dispenses 69 μL of ICT Sample Diluent (ICTD5) and 276 μL of water into
the cuvette.
3. Mixer 1 mixes the sample, the diluent, and the water.
4. The reaction carousel continues to rotate until the cuvette aligns with the ICT unit. The
cuvette alignment occurs after 37 reaction carousel movements.
5. The ICT unit moves out and down to position the ICT probe in the cuvette.
6. The syringe on the right side of the ICT aspiration pump aspirates the sample from the
cuvette into the ICT module.
7. The ICT module measures the sample. The system converts the measurements into millivolt
readings that are used to calculate sample result concentrations.

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8. The syringe on the right side of the ICT aspiration pump moves the sample from the ICT
module to the high-concentration waste compartment.
9. The syringe on the left side of the ICT aspiration pump aspirates the liquid waste from the
high-concentration waste compartment.
10. The syringe on the left side of the ICT aspiration pump moves the liquid waste to the high-
Measurement by the ICT module (c‑series)

The ICT module measures:
• ICT Reference Solution (once before and after each serum sample and twice before and
after each urine sample) to provide a reference potential that is used to calculate results.
• Samples (patient, quality control, and calibrator) to obtain readings that are used to
calculate results.
The following measurements are captured:

• The potential difference between the sample and the ICT Reference Solution for each
electrode
• The potential of each electrode in contact with the ICT Reference Solution
• The potential of each electrode in contact with the sample
The following figure shows internal components of the ICT module. The direction of the sample
flow is indicated by the arrow.

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Figure 106: ICT module and internal components (c‑series)
Legend:
1. O-ring
2. Reference electrode
3. Cl- electrode
4. K+ electrode
5. Na+ electrode
Data reduction calculation (c‑series potentiometric)

The data reduction calculation is used to calculate the final result concentration. For each
sample, the system compares millivolt readings from the sample to millivolt readings from the
ICT Reference Solution that is analyzed immediately after the sample. The difference in the
millivolt readings is used to calculate assay results.

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Assay processing (c‑series)

Many kinds of assay-processing activities occur between sample aspiration and final result
reporting. Components that are located around the reaction carousel perform these activities.
Figure 107: Assay-processing components (c‑series)
Legend:
1. Sample pipettor
2. Sample probe and whole blood wash cups
3. Mixers
4. Mixer wash cups
5. ICT unit
6. Lamp
7. Reagent 2 pipettor and wash cup

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8. Cuvette washer
9. Cuvette segments
10. Reagent 1 pipettor and wash cup
The movement of the reaction carousel, the timing of these movements, and the position of the
components cause each reaction activity to occur at a specified time and location.
During assay processing, the reaction carousel rotates counterclockwise one-fourth turn every 4
seconds to position the cuvettes at each location. Each rotation moves incrementally to 47
cuvette positions in the reaction carousel. As each rotation occurs, the cuvettes pass the
photometric position where the lamp is located, and the photometer measures the absorbance of
each cuvette.
The following illustration shows key positions in the reaction carousel where activities occur.
Figure 108: Reaction carousel positions
The following table describes the movement and timing for all assay protocol types.
Position Description
1 The sample pipettor dispenses the sample into the cuvette at the starting position
[1].

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2 The reaction carousel rotates one-fourth turn (47 cuvette positions). The cuvette
that contains the sample is located at the first reagent dispense position [2].
Reagent 1 pipettor dispenses reagent 1 into the cuvette.
3 The reaction carousel rotates one-fourth turn to the first mixing position [3] where
mixer 1 mixes the sample and reagent 1.
Rotation from 3 to 4 As the reaction carousel rotates from position 3 to position 4, the cuvette passes
the photometric position [6] where the lamp is located, and the photometer
measures the absorbance.
4 No activity occurs in this position [4].
5 The reaction carousel completes a full rotation of four cycles. Each cycle rotates
the reaction carousel 47 cuvette positions (one-fourth turn). After four cycles are
completed, the cuvette has moved 188 positions (4 x 47 = 188). Since the reaction
carousel has 187 cuvettes, the cuvette is now one position beyond the original
starting position [5].
6 through 153 The reaction carousel continues to rotate and the reaction mixture incubates. The
photometer measures the absorbance each time that the cuvette passes the
photometric position [6] for a total of 38 readings.
154 through 182 The cuvette washer [7] aspirates the reaction mixture to waste and cleans the
cuvette with Alkaline Wash, Acid Wash, and purified water. Then, the cuvette
washer dispenses purified water into the cuvette for the water blank measurement,
which ensures cuvette integrity. Finally, the cuvette washer aspirates the water and
dries the cuvette.
183 through 188 The clean cuvette rotates to the starting position [1].
Some assay protocols can also use the following positions.

5 If onboard dilution is required, the sample pipettor aspirates the diluted sample [5]
and dispenses the sample into the new cuvette that is located at position 1.
40 For an ICT sample, the ICT probe aspirates the diluted sample into the ICT unit [8].
75 If the reaction requires a second reagent, the reagent 2 pipettor dispenses reagent
2 into the cuvette [9].
76 Mixer 2 [10] mixes the second reagent with the sample and reagent mixture.
The following illustration shows the relationship between the timing of photometric readings and
the dispense of samples and reagents. The maximum reaction time is 10 minutes.

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Figure 109: Photometric timing (c‑series)
Where:
Abs Absorbance
SD Sample dispense
FRD First reagent dispense and mixing
SRD Second reagent dispense and mixing
Assay processing for a one-reagent protocol (c‑series), page 417
Assay processing for a two-reagent protocol (c‑series), page 419
Assay processing for a dilution protocol (c‑series), page 420
Assay processing for a pretreatment protocol (c‑series), page 421
Assay processing for an ICT protocol (c‑series), page 422
Assay processing for a one-reagent protocol (c‑series)

The following steps describe the assay processing and the photometric reaction that occurs
during a one-reagent assay protocol.

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Figure 110: One-reagent assay protocol (c‑series)
Legend:
1. At position 1, the sample pipettor aspirates sample and then dispenses the sample into a cuvette.
2. At position 2, the reagent 1 pipettor aspirates reagent and then dispenses the reagent into the
cuvette.
3. At position 3, mixer 1 mixes the sample and the reagent.
4. At positions 4 through 153, the reaction mixture incubates, and the photometer measures the
absorbance each time that the cuvette passes the photometric position [6].
5. At positions 154 through 182, the cuvette washer aspirates the reaction mixture to waste and cleans
the cuvette with Alkaline Wash, Acid Wash, and purified water. Then, the cuvette washer dispenses
purified water into the cuvette for the water blank measurement, which ensures cuvette integrity.
Finally, the cuvette washer aspirates the water and dries the cuvette.

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Assay processing for a two-reagent protocol (c‑series)

The following steps describe the assay processing and the photometric reaction that occurs
during a two-reagent assay protocol.
Figure 111: Two-reagent assay protocol (c‑series)
Legend:
2. At position 2, the reagent 1 pipettor aspirates reagent and then dispenses the reagent into the
cuvette.
3. At position 3, mixer 1 mixes the sample and the reagent.
4. At positions 4 through 74, the reaction mixture incubates and the photometer measures the
absorbance each time that the cuvette passes the photometric position [7].
5. At position 75, the reagent 2 pipettor aspirates the reagent and then dispenses the second reagent
into the cuvette.
6. At position 76, mixer 2 mixes the second reagent with the sample and reagent mixture.
7. At positions 77 through 153, the reaction mixture incubates, and the photometer measures the
absorbance each time that the cuvette passes the photometric position.

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Finally, the cuvette washer aspirates the water and dries the cuvette.
Assay processing for a dilution protocol (c‑series)

The following steps describe the assay processing that occurs when a sample is diluted before a
one-reagent or two-reagent assay protocol is performed.
Figure 112: Assay processing for a dilution protocol (c‑series)
Legend:
1. At position 1, the sample pipettor aspirates the sample and then dispenses the sample into a cuvette.
2. At position 2, the reagent 1 pipettor aspirates the diluent and then dispenses the diluent into the
cuvette.
3. At position 3, mixer 1 mixes the sample and the diluent.

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4. At position 5, the sample pipettor aspirates the diluted sample and then dispenses the diluted sample
into a new cuvette. Then, the system processes the diluted sample according to the one-reagent or
two-reagent assay protocol as appropriate.
Assay processing for a pretreatment protocol (c‑series)

The following steps describe the assay processing that occurs when a sample is pretreated
before a one-reagent or two-reagent assay protocol is performed.
Figure 113: Assay processing for a pretreatment protocol (c‑series)
Legend:
1. At position 1, the sample pipettor aspirates the sample and then dispenses the sample into a cuvette.
2. At position 2, the reagent 1 pipettor aspirates the pretreatment reagent and then dispenses the
pretreatment reagent into the cuvette.
3. At position 3, mixer 1 mixes the sample and the pretreatment reagent.

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4. At position 5, the sample pipettor aspirates the pretreated sample and then dispenses the pretreated
sample into a new cuvette. Then, the system processes the pretreated sample according to the one-
reagent or two-reagent assay protocol as appropriate.
Assay processing for an ICT protocol (c‑series)

The following steps describe the assay processing and the potentiometric reaction that occurs
for integrated chip technology (ICT) assays.
Figure 114: ICT assay protocol (c‑series)
Legend:
2. At position 2, the reagent 1 pipettor aspirates ICT Sample Diluent and then dispenses the ICT Sample
Diluent into the cuvette.
3. At position 3, mixer 1 mixes the sample and the ICT Sample Diluent.

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4. At position 40, the ICT probe aspirates the diluted sample, and then the ICT module analyzes the
diluted sample.
NOTE: The ICT module analyzes the ICT Reference Solution once before and after each serum
sample and twice before and after each urine sample to provide a reference potential that is used to
calculate results.
Finally, the cuvette washer aspirates the purified water and dries the cuvette.
Indirect assay processing method (c‑series)

The indirect assay processing method for photometric assays provides for two results to be
generated from one cuvette during a single assay processing cycle. The assay pair has primary
and secondary assays. The two assays are used as constituent assays for the calculated assay
result. This option is available only when the assay parameters are installed from an assay file
that is provided by Abbott Laboratories.
The two assays must be ordered at the same time when calibrations, specimens, and controls
are processed. Each assay generates its own calibration, control results, and specimen results.
The information on the General tab of the Assay Parameters screen can be used to determine if
an assay is a primary or a secondary assay. The reagent volumes of the secondary assay are
configured as zero.
SmartWash feature (c‑series)

SmartWash is a c‑series feature that provides an additional wash process (when needed) for
reagent probes, sample probes, and cuvettes. The SmartWash feature is used during assay
processing to reduce interference (carryover) between specific assay combinations.
To reduce reagent carryover between assays known to demonstrate it, configure the assay
combination as a SmartWash pair. This configuration option provides for an additional wash
process between the measurement of the assays.
NOTE: The configuration of SmartWash parameters for Abbott reagents is determined by
reagent carryover studies that identify assay pairs that do not meet the reagent carryover
criteria.
Reagent carryover specifications of the c‑series meet or exceed the bias or total allowable error
requirements for each assay. The specifications are developed by using internationally

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recognized assay performance criteria. The following list provides examples of recognized assay
performance criteria:
• The U.S. Clinical Laboratory Improvement Act (CLIA)
• Guidelines for Quality Assurance of Medical Laboratory Examinations of the German
Medical Association
• National Academy of Clinical Biochemistry (NACB)
• National Kidney Disease Education Program (NKDEP) Guidelines
• Desirable Biological Variation Database Specifications (C. Ricos et al.)
When possible, reagent carryover testing is performed by using serum-based control samples
that contain analyte concentrations near medical decision levels. Assay pairs that meet the
reagent carryover criteria are not configured with SmartWash parameters. In some instances,
because of system-specific conditions, customers may choose to configure SmartWash
parameters for Abbott assay pairs.
To minimize the consecutive measurement of assays configured as SmartWash pairs, the
c‑series uses the optimum sampling sequence feature, which automatically changes the
sampling sequence.
Reagent carryover evaluation (c‑series), page 1605
Perform a reagent carryover evaluation (c‑series), page 1605
Configure and verify SmartWash settings (c‑series), page 1608
Edit SmartWash settings (c‑series), page 1610
Optimum sampling sequence feature (c‑series)

The optimum sampling sequence (OSS) feature is an automatic process in which the c‑series
rearranges the sampling sequence to maximize the processing speed and the system
throughput. This rearrangement prevents the consecutive aspiration of interfering reagents and
therefore reduces the number of required washes and unused cuvettes. If this rearrangement is
not possible, the system automatically activates the SmartWash feature.
In the following example, assays A, B, and C are ordered and a SmartWash parameter is
configured for A and B. The elimination of the wash cycle shows how throughput is improved
when the OSS feature is used.
OSS feature not used OSS feature used
Cycle System operations Cycle System operations
1 Sampling for assay A 1 Sampling for assay B
2 Wash (empty cuvettes) 2 Sampling for assay A

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OSS feature not used OSS feature used

Cycle System operations Cycle System operations
3 Sampling for assay B 3 Sampling for assay C
4 Sampling for assay C
Sample interference indices (c‑series)

The sample interference indices are sample measurements that estimate the presence of lipids,
hemoglobin, and bilirubin in lipemic, hemolyzed, and icteric samples, respectively. The estimation
is based on the absorbance measurement of:
• Turbidity for lipids (lipemia).
• Red color for hemoglobin (hemolysis).
• Yellow color for bilirubin (icterus).
Sample interference indices protocol (c‑series), page 425
Sample interference indices measurement (c‑series), page 425
Sample interference indices protocol (c‑series)

The sample interference indices protocol measures lipemia, hemolysis, and icterus in a sample.
Saline is configured as a reference photometric assay that the system uses to estimate the
indices for a sample. Analysis of the three indices requires one additional cuvette for each
sample.
Sample interference indices measurement (c‑series)

Sample interference indices measurement is the process that the c‑series uses to measure
lipemia, hemolysis, and icterus in a sample after the sample has been mixed with saline.
Specimens that contain interfering substances such as lipemia, hemolysis, and icterus absorb at
different wavelengths as shown in the following figure.

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Figure 115: Absorption spectra of NADH and hemolyzed, icteric, and lipemic samples
(c‑series)
Where:
Abs Absorbance
λ (nm) Wavelength (nm)
N NADH, the reference absorbance peak
H Hemolysis
I Icterus
L Lipemia
To measure the three interfering substances, first the system measures absorbance values of
four wavelength pairs. Then by using the appropriate photometric reads, the system applies a
mathematical calculation to determine the relative interferent concentration:
• Lipemia = M (a01 x A1 + a02 x A2 + a03 x A3 + a04 x A4)
• Hemolysis = M (a05 x A1 + a06 x A2 + a07 x A3 + a08 x A4)
• Icterus = M (a09 x A1 + a10 x A2 + a11 x A3 + a12 x A4)

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Where:
M The correction for the sample dilution is (Reagent
volume + Sample volume) ÷ Sample volume.
Constants that are specific to each interferent: Constants are used by the system to calculate the
• a01, a02, a03, a04 (lipemia) sample interference indices. Constants are not
• a05, a06, a07, a08 (hemolysis) definable by the operator.
• a09, a10, a11, a12 (icterus)
Absorbance level that is measured at wavelength Absorbance primary wavelength - Absorbance
pairs: secondary wavelength
• A1 (500 nm/524 nm)
• A2 (572 nm/604 nm)
• A3 (628 nm/660 nm)
• A4 (524 nm/804 nm)

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Principles of operation (i‑series) Section 3
Principles of operation (i‑series)

Principles of operation for the i‑series provide an overview of chemiluminescent microparticle
immunoassay (CMIA) detection technology, assay processing, and the optical system used for
analyte measurement.
Principles of operation, page 401
CMIA method (i‑series), page 428
CMIA method (i‑series)

Chemiluminescent microparticle immunoassay (CMIA) is a detection technology used to measure
analyte concentration.
CMIA technology and reaction sequence (i‑series), page 428
Optical system and measurement sequence (i‑series), page 431
Data reduction calculation (i‑series), page 433
CMIA technology and reaction sequence (i‑series)

Chemiluminescent microparticle immunoassay (CMIA) detection technology is used to determine
the presence of antigens, antibodies, and analytes in samples.
The following reactants and analyte are necessary for CMIA detection technology:
Paramagnetic microparticles coated with capture molecules (antigens,

antibodies, or viral particles) that are specific for the analyte being
measured
Sample analyte that is measured

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Section 3 Principles of operation (i‑series)
Acridinium-labeled conjugate
Trigger Solution
A CMIA reaction sequence is the order of interactions between the analyte in the sample and the
reactants. The sequence is specific to the assay protocol.
The following two-step sequence illustrates the basic principles of a reaction.

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Figure 116: CMIA reaction sequence
1. The sample and the paramagnetic microparticles coated with capture molecules are
dispensed into the reaction vessel (RV). The vortexer mixes the reaction mixture.
2. The reaction mixture incubates. The analyte in the sample binds to the capture molecules
on the paramagnetic microparticles and forms an immune complex.
3. A magnet attracts the paramagnetic microparticles (which are bound to the specific analyte)
to a wall of the RV. The wash zone assembly washes the reaction mixture to remove
unbound materials. Additional assay processing can now occur.
4. The pipettor dispenses a chemiluminescent, acridinium-labeled conjugate into the RV. The
conjugate binds to the immune complex to complete the reaction mixture. The vortexer
mixes the reaction mixture.
The reaction mixture incubates.
5. The wash zone assembly washes the reaction mixture to remove unbound materials.
6. The Pre-Trigger Solution nozzle dispenses the Pre-Trigger Solution (hydrogen peroxide) into
the reaction mixture. The vortexer mixes the reaction mixture. The Pre-Trigger Solution:
– Creates an acidic environment to prevent the early release of energy (light emission).

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– Helps to prevent any clumping in microparticles.

– Separates the acridinium dye from the conjugate that is bound to the microparticle
complex. This action prepares the acridinium dye for the next step.
The CMIA optical system performs a background read.

7. The Trigger Solution nozzle dispenses the Trigger Solution (sodium hydroxide) into the
reaction mixture. The Trigger Solution creates an alkaline environment that, with the
exposure to peroxide in the Pre-Trigger Solution, causes the acridinium dye to undergo an
oxidative reaction. The oxidative reaction causes a chemiluminescent reaction to occur. N-
methylacridone forms and releases energy (light emission) as N-methylacridone returns to
its ground state.
The CMIA optical system measures the chemiluminescent emission (activated read) over a
predefined time period to determine a result.
Optical system and measurement sequence (i‑series)

The optical system on the processing module directs the chemiluminescent emission from the
reaction vessel (RV) to the optics. The i‑series module uses an optical measurement to obtain
relative light unit (RLU) readings and then converts them to assay-specific analyte concentration
units or qualitative interpretations for index (cutoff) assays.

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Figure 117: Optical system (i‑series)
Legend:
1. Photomultiplier tube (PMT)
2. Optics
3. Light pipe
4. Trigger Solution delivery nozzle
5. RV
6. Shutter assembly
7. Magnet
The measurement sequence occurs as the optical system performs the following actions:
1. Closes the shutter around the RV to seal off ambient light.
2. Turns on the high voltage to the PMT, performs a background read (the Pre-Trigger Solution
has been dispensed), and transfers the data to the computer.
3. Dispenses the Trigger Solution into the RV. This solution initiates the chemiluminescent
reaction that results in the emission of photons of light.
4. Uses the light pipe to collect the emitted photons of light and directs them to the PMT,
which is located in the CMIA reader.
5. Performs an activated read with the collected photons of light.
6. Transfers the count data to the computer. Based on the assay type, the chemiluminescent
light produced during this reaction is directly proportional or indirectly proportional to the
amount of analyte in the sample.

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7. Sums the signal over a defined time period to yield the RLU.
8. Turns off the high voltage to the PMT.
9. Opens the shutter.
Optics (Alinity i), page 116
Data reduction calculation (i‑series)

The data reduction calculation is used to calculate the final read in relative light units (RLUs):
Final read (RLUs) = Activated read - Background
When the calculation is performed:
1. The system sums the signal measured by the CMIA optical system.
2. The system verifies the following information:
– Background counts fall within an acceptable range.
– The activated read profile falls within an acceptable set of ranges.
3. The system subtracts background counts from activated read counts to calculate the final
read.
Assay processing (i‑series)

Many kinds of assay-processing activities occur between sample aspiration and final result
reporting. Movements of the process path, the timing of these movements, and positions of
components cause each reaction activity to occur at a specified time and location.
The technology of the i‑series provides a variety of assay protocols or assay-processing
methods. Based on the protocol type, assay-processing steps occur at different positions on the
process path.
Assay processing for One Step 25 (i‑series), page 434
Assay processing for Two Step 18-4 (i‑series), page 435
STAT assay processing for One Step 11 (i‑series), page 439
STAT assay processing for Two Step 4-4 (i‑series), page 440

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Assay processing for One Step 25 (i‑series)

A One Step 25 assay protocol is a method of assay processing in which the sample and all
required reagents are added to the reaction vessel (RV) before the microparticles are washed.
The total processing time for a One Step 25 assay protocol is 29 minutes, which includes a 25-
minute incubation time.
The following steps describe the assay processing and the CMIA reaction that occurs during a
One Step 25 assay protocol.
Figure 118: One Step 25 assay protocol (i‑series)
1. At position 1, the sample pipettor dispenses the sample into the RV.
2. At position 2, the reagent 1 pipettor dispenses microparticles and the acridinium-labeled
conjugate.
NOTE: For a delayed one-step assay, the reagent 2 pipettor adds the acridinium-labeled
conjugate at position 71 and the vortexer mixes the reaction mixture at position 72.
3. At position 3, the vortexer mixes the sample, microparticles, and the conjugate.

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4. At positions 4 through 86, the reaction mixture incubates for 25 minutes.

5. At positions 87 through 90, wash zone 2 washes the reaction mixture in the RV and then
removes unbound materials.
6. At position 94, the Pre-Trigger Solution nozzle dispenses the Pre-Trigger Solution into the
reaction mixture, and then the vortexer mixes the reaction mixture.
7. At position 98, the CMIA optical system performs a background read, the Trigger Solution
nozzle dispenses the Trigger Solution into the reaction mixture, and then the CMIA optical
system performs an activated read.
8. At position 100, the liquid waste arm aspirates the liquid waste from the RV.
9. At position 101, the RV unloader removes the RV and discards it into the solid waste
container.
Assay processing for Two Step 18-4 (i‑series)

A Two Step 18-4 assay protocol is a method of assay processing in which the sample and some
reagents are added to the reaction vessel (RV) before the microparticles are washed. The
conjugate reagent is added to the RV after the microparticles are washed. The total processing
time for a Two Step 18-4 assay protocol is 29 minutes, which includes a 22-minute incubation
time.
Two Step 18-4 assay protocol.

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Figure 119: Two Step 18-4 assay protocol (i‑series)
2. At position 2, the reagent 1 pipettor dispenses microparticles.
3. At position 3, the vortexer mixes the sample and microparticles.
6. At position 71, the reagent 2 pipettor dispenses the acridinium-labeled conjugate.
7. At position 72, the vortexer mixes the reaction mixture.

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container.
Assay processing for pretreatment (i‑series)

A pretreatment assay protocol has additional steps that are performed before a one-step or two-
step assay protocol is performed. The i‑series module automatically performs these steps when
pretreatment is required.
Based on the pretreatment type, incubation times and the number of pretreatment reagents vary.
Two pretreatment assay protocols are available for use:
• Pretreatment 7 performs the pretreatment assay protocol once and requires an additional 7
minutes.
• Pretreatment 7-7 performs the pretreatment assay protocol twice and requires an additional
14 minutes.
pretreatment assay protocol.

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Figure 120: Pretreatment assay protocol (i‑series)
1. At pretreatment position 1, the sample pipettor dispenses the sample into the reaction vessel
(RV).
2. At pretreatment position 2, the reagent 1 pipettor dispenses the first pretreatment reagents
into the sample in the RV.
3. At pretreatment position 6, the vortexer mixes the sample and pretreatment reagents.
4. At pretreatment positions 7 through 48, the reaction mixture incubates for 7 minutes.
5. At pretreatment position 48, the sample pipettor performs one of the following actions to
complete the pretreatment assay protocol:
– Transfers the pretreated sample to a new RV in pretreatment position 1 to process a
second 7-minute pretreatment assay protocol (Pretreatment 7-7)
– Transfers the pretreated sample to a new RV in process path position 1 (Pretreatment
7)
After the pretreatment assay protocol is completed, the one-step or two-step assay protocol
begins.

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STAT assay processing for One Step 11 (i‑series)

A One Step 11 assay protocol is a method of assay processing in which the sample and all
required reagents are added to the reaction vessel (RV) before the microparticles are washed. A
One Step 11 assay protocol has a shorter incubation time than a One Step 25 assay protocol.
The total processing time for a One Step 11 assay protocol is 15 minutes, which includes an 11-
minute incubation time.
One Step 11 assay protocol.
Figure 121: One Step 11 assay protocol (i‑series)

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2. At position 2, the reagent 1 pipettor dispenses microparticles and the acridinium-labeled

conjugate.
3. At position 3, the vortexer mixes the sample, microparticles, and the conjugate.
container.
STAT assay processing for Two Step 4-4 (i‑series)

A Two Step 4-4 assay protocol is a method of assay processing in which the sample and some
reagents are added to the reaction vessel (RV) before the microparticles are washed. The
conjugate reagent is added to the RV after the microparticles are washed. A Two Step 4-4 assay
protocol has a shorter incubation time than a Two Step 18-4 assay protocol. The total
processing time for a Two Step 4-4 assay protocol is 18 minutes, which includes an 8-minute
incubation time.
Two Step 4-4 assay protocol.

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Figure 122: Two Step 4-4 assay protocol (i‑series)
2. At position 2, the reagent 1 pipettor dispenses microparticles.
3. At position 3, the vortexer mixes the sample and microparticles.
6. At position 25, the reagent 2 pipettor dispenses the acridinium-labeled conjugate.
7. At position 26, the vortexer mixes the reaction mixture.

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container.

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Section 4 Performance characteristics and specifications
Introduction
Before operating the Alinity ci‑series, become familiar with system performance characteristics,
throughput capabilities and capacities, specifications, and requirements for samples,
temperature, waste, and clearance.
System characteristics, page 444

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Performance characteristics and specifications
System characteristics Section 4
System characteristics
System characteristics provide a basic overview of the Alinity ci‑series.
For additional characteristics that are specific to a processing module, see the appropriate
module type.
Table 4: System characteristics
Primary components • System control module

• Reagent and sample manager
• Processing module
Bar code reader Located on the RSM transport
Onboard data storage 2 solid-state hard drives
Operator interface • Touchscreen monitor
• Bar code scanner
Priority scheduling • 0 to 25 configurable priority positions per processing module
• Unlimited temporary priority positions
Quality control • Levey-Jennings and Westgard rules
• Control range tracking
Stored data protection Uninterrupted power supply (UPS) (optional)
Performance characteristics and specifications, page 443
Processing module characteristics (c‑series), page 444
Processing module characteristics (i‑series), page 445
Processing module characteristics (c‑series)

Table 5: Processing module characteristics (c‑series)
Detection technology:
• Photometric End-point and rate
• Potentiometric Integrated chip technology (ICT) ion-selective electrodes
Pipetting capability Robotic precision with clot detection

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Section 4 System characteristics
Processing module characteristics (i‑series)

Table 6: Processing module characteristics (i‑series)
Detection technology Chemiluminescent microparticle immunoassay (CMIA)

Emission measurement The optics measures the chemiluminescent emission from reaction
vessels and outputs the data that corresponds to the quantity of emission
detected.
Pipetting capability Robotic precision with clot detection

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Specifications and requirements Section 4
Specifications and requirements

Specifications and requirements for the Alinity ci‑series pertain to the appropriate installation and
operation of the system.
Performance characteristics and specifications, page 443
Operational specifications, page 446
System capacities, page 449
Physical specifications, page 452
Typical floor loading, page 453
System clearances, page 455
Electrical specifications and requirements, page 455
Optical specifications (c‑series), page 458
Water and liquid waste specifications and requirements, page 459
Environmental specifications and requirements, page 461
Computer and interface specifications, page 462
External waste pump specifications and requirements, page 463
Bar code label requirements, page 465
Sample specifications and requirements, page 472
System installation, page 166
Operational specifications
Operational specifications for processing modules include the following information:
• Dispensing volumes
• Sample probe carryover specifications
• Processing temperatures
• Module throughput and time to first result
• System status transition times
Processing module operational specifications (c‑series), page 447
Processing module operational specifications (i‑series), page 448

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Section 4 Specifications and requirements
Processing module operational specifications (c‑series)

Table 7: Processing module operational specifications (c‑series)
Dispensing volumes:
• Sample pipettor 1.5 µL to 35 µL in 0.1 µL increments
• Sample pipettor (ICT) 15 µL per sample
• Reagent 1 pipettor • Reagent 1
45 µL to 250 µL in 1 µL increments
• Onboard solutions
• Reagent 2 pipettor • Reagent 2
• ICT Reference Solution 550 µL per sample
Sample probe carryover performance:
• Serum, plasma, urine, cerebrospinal fluid, and ≤ 0.10 ppm
hemolysate (single replicate)
• Whole blood ≤ 1000 ppm
Temperature:
• Onboard reagent refrigerator 2°C to 10°C
• Reaction mixture 36.7°C to 37.3°C
Throughput:
• Photometric assays Maximum of 900 tests per hour (serum, plasma,
urine, cerebrospinal fluid, and hemolysate
applications)
• Potentiometric assays Maximum of 675 tests per hour
• Whole blood assays Maximum of 225 tests per hour
• Photometric and potentiometric assay mix: Maximum of 1350 tests per hour
– 25% potentiometric (3 tests per sample)
• Mixed load list: Maximum of 900 tests per hour
– 1% to 3% whole blood tests
– 10% to 20% potentiometric tests
• Time to first result • 10 min or less (photometric)
NOTE: The time to first result starts at • 4 min or less (potentiometric)
aspiration and does not include sample
handling.
System status transition times:
NOTE: The Stopped to Processing and Idle to
Processing time intervals were generated with a

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sample loaded on the reagent and sample manager

(RSM). If a sample is not loaded, the cuvettes are
filled with water and the system status transitions to
Running.
Processing module (c‑series):

• Offline to Stopped 1 min
• Stopped to Idle 2 min
• Stopped to Processing 6 min
• Idle to Processing (with a sample loaded on 4 min
the RSM)
• Idle to Processing (with no sample loaded on 21 min
the RSM)
RSM:
• Stopped to Idle 15 s
• Stopped to Running 30 s
• Idle to Running 30 s
Processing module operational specifications (i‑series)

Table 8: Processing module operational specifications (i‑series)
Dispensing volumes:
• Sample 2 µL to 200 µL in 1 µL increments
• Reagent 5 µL to 150 µL in 1 µL increments
• Pre-Trigger Solution 100 µL per test
• Trigger Solution 300 µL per test
Sample probe carryover performance ≤ 0.10 ppm (serum, plasma, and other body fluids)
Temperature:
• Onboard reagent refrigerator 2°C to 12°C
• Reaction mixture 36.4°C to 37.6°C
Throughput:
• Routine assays Maximum of 200 tests per hour
• STAT assays Maximum of 200 tests per hour
• Pretreatment 7 assays Maximum of 200 tests per hour
• Pretreatment 7-7 assays Maximum of 100 tests per hour
• Mixed load list: Maximum of 170 tests per hour
– 10% pretreatment

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– 25% STAT
– 65% routine
• Time to first result • 29 min (routine)
NOTE: The time to first result starts at • 36 min to 43 min (pretreatment)
aspiration and does not include sample • 15 min (STAT)*
handling. * The estimated processing time including
sample handling is 18 min.
System status transition times:
Processing module (i‑series):
• Stopped to Idle 3 min
• Stopped to Running 7 min
• Idle to Running 4 min to 7 min*
* If the pretreatment path is repopulated with
reaction vessels, the duration of initialization is
7 min.
Reagent and sample manager:
• Stopped to Idle 15 s
• Stopped to Running 30 s
• Idle to Running 30 s
System capacities
System capacities include storage information for the software data, processing modules, and
the reagent and sample manager.
Software data storage capacities, page 449
Processing module capacities (c‑series), page 450
Processing module capacities (i‑series), page 451
Reagent and sample manager capacities, page 452
Software data storage capacities

Table 9: Software data storage capacities
Assay files 200 assay files

Calibrations:

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• Active • 1 active calibration for a maximum of 4

different reagent lots for each assay on a
processing module
• Inactive • Maximum of 3 months
Calibration and quality control inventory 2500 vials per processing module
Levey-Jennings graph data Maximum of 4 months
System log 120,000 messages
Print spooler 10 print requests
Reagent cartridges 1000 cartridges per processing module
Released control results* 20,000 results per processing module
Released specimen results* 200,000 results
Unreleased results:* 20,000 results
• Specimens
• Controls
• Calibrations
Unreleased results include test orders, tests in
process, and exceptions.
* Results include system-ordered constituents for calculated assays. The constituent results
cannot be displayed on the Results screen.
Processing module capacities (c‑series)

Table 10: Processing module capacities (c‑series)
Bulk solutions:
• ICT Reference Solution 975 mL
• Alkaline Wash 500 mL
• Acid Wash 500 mL
Bulk solution reservoirs:
• ICT Reference Solution reservoir 1L
• Alkaline Wash reservoir 0.5 L
• Acid Wash reservoir 0.5 L
Reagent carousel positions 70
NOTE: Four of the 70 positions are available for the
storage of onboard vial racks.
Reaction carousel 187 cuvettes

Reaction cuvettes:
• Minimum volume 80 µL

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• Maximum volume 360 µL

High-concentration waste bottle:
• Volume 10 L
• Weight 10 kg (22 lb)
Processing module capacities (i‑series)

Table 11: Processing module capacities (i‑series)
Bulk solutions:
• Pre-Trigger Solution 975 mL
• Trigger Solution 975 mL
• Concentrated Wash Buffer 2L
Bulk solution reservoirs:
• Pre-Trigger Solution reservoir 1L
• Trigger Solution reservoir 1L
• Concentrated Wash Buffer reservoir 2L
• Diluted wash buffer reservoir 4L
Biohazard bag size • 5 gal
• 39.37 cm (15.5 in.) x 57.15 cm (22.5 in.)
Process path positions 46
Pretreatment path positions 61
Reagent carousel positions 47
Reaction vessel (RV):
• Total volume 1000 µL
• Maximum reaction mixture volume 400 µL
RV hopper 1000 RVs
Solid waste:
• Container capacity • 1000 RVs
• 5 h of run time at 200 RVs/h
• Waste chute capacity • 50 RVs before system operation is paused
• 208 RVs total capacity
• 30 min of run time when the waste container is
removed during assay processing

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Reagent and sample manager capacities

Table 12: Reagent and sample manager capacities
Bays 5 per processing module

Priority sections Configurable
0 to 25
Racks: 6 positions per rack
• Sample rack
• Vial rack
• Onboard vial rack
Trays • 5 sample racks or 30 positions
• 5 reagent cartridges
Physical specifications
The approximate physical specifications for the Alinity ci‑series are described in the table for the
following configurations:
Stand-alone Includes the specifications for the processing module

processing module (Alinity c or Alinity i), the reagent and sample manager (RSM),
and the system control module (SCM)
Each additional Includes the specifications for one processing module

processing module (Alinity c or Alinity i)
All weights include fluids and bulk solutions at capacity to depict a worst-case scenario.
Table 13: Physical specifications
Module Depth Width Height Weight

Stand-alone 116.9 cm (46.0 in.) 118.9 cm (46.8 in.) 133.5 cm (52.6 in.) • Alinity c
processing module 711.6 kg
(1568.9 lb)
• Alinity i
623.2 kg
(1373.9 lb)
Each additional 116.9 cm (46.0 in.) 80.3 cm (31.6 in.) 133.5 cm (52.6 in.) • Alinity c
processing module 536.6 kg
(1183.0 lb)
• Alinity i

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Module Depth Width Height Weight

448.2 kg
(988.1 lb)
Typical floor loading

Typical floor loads at each pad are provided in the following tables.
NOTE: Floor loading is the distribution of force at the pads on a leveled system. Distributed
loads vary with the mechanical linking of modules and pad adjustment.
Figure 123: Alinity c single-module system
Table 14: Alinity c weight specifications
Load at each foot 1. 118.8 kg (262 lb)

2. 186.9 kg (412 lb)
3. 140.1 kg (309 lb)
4. 83.5 kg (184 lb)

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5. 22.7 kg (50 lb)

6. 27.2 kg (60 lb)
7. 29 kg (64 lb)
8. 32.2 kg (71 lb)
Figure 124: Alinity i single-module system
Table 15: Alinity i weight specifications
Load at each foot 1. 189.6 kg (418 lb)

2. 125.6 kg (277 lb)
3. 37.2 kg (82 lb)
4. 141.1 kg (311 lb)
5. 11.3 kg (25 lb)
6. 17.2 kg (38 lb)
7. 52.6 kg (116 lb)
8. 10 kg (22 lb)

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System clearances
Table 16: System clearances
Left and right clearances 60 cm (24 in.)

(to allow the positioning of the processing module
so that the power connector can be disconnected
from the module without difficulty)
Rear clearance 107 cm (42 in.)
(for safety access to main circuit breakers, cooling,
airflow, cable and tubing routing, maintenance, and
traffic)
Above clearance 195.6 cm (77 in.)
(to open the processing center covers and to allow
for the height of the distance alert)
Front clearance 122 cm (48 in.)
(to open the front doors and to access, remove, and
replace bulk solutions)
NOTE: For the required clearances of systems that are connected to a laboratory automation
system (LAS), refer to the LAS vendor documentation.
General requirements, page 810
Electrical specifications and requirements

Electrical specifications and requirements include information about circuits, outlet types, and
outlet requirements.
System control module (SCM) electrical specifications and requirements, page 456
Processing module electrical specifications and requirements (c‑series), page 456
Processing module electrical specifications and requirements (i‑series), page 457
Electrical hazards, page 832

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System control module (SCM) electrical specifications and requirements

Table 17: System control module (SCM) electrical specifications and requirements
AC power:*
• Voltage 90 VAC to 264 VAC
• Frequency 47 Hz to 63 Hz
Typical circuit breaker that can be reset:**
• North America 20 A
• International 16 A
NOTE: If an uninterrupted power supply (UPS) is

used with the system, see the UPS manufacturer
specifications.
Outlet (1):
• North America (twistlock) NEMA L6-20R (240 VAC, 20 A)
• North America NEMA 5-20R (120 VAC, 20 A)
• Universal IEC 60309 (IP44 Blue) 2P 3W (250 VAC, 16/20 A)
NOTE: If an UPS is used with the system, see the

UPS manufacturer specifications.
Power cord length 3.7 m (12 ft)

Rated power consumption* Maximum of 1500 VA (1.5 kVA)
* If an UPS is used, the UPS must meet the voltage, frequency, and power consumption
requirements for the combined modules connected to the UPS. It is recommended that the UPS
be approved for safety by a Nationally Recognized Testing Laboratory (NRTL) such as UL or
TUV. In addition, it is recommended that the UPS meets the electromagnetic compatibility (EMC)
requirements in IEC 62040-2.
** The circuit breaker selection is dependent on the input voltage supplied by the laboratory and
the Volt-Ampere requirement of the module.
Processing module electrical specifications and requirements (c‑series)

Table 18: Processing module electrical specifications and requirements (c‑series)
AC power:*

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• Frequency 50 Hz or 60 Hz

specifications.
Heat dissipation • Idle: 1950 Btu

• Processing: 2005 Btu
Outlet (1):
• Universal IEC 60309 (IP44 Blue) 2P 3W (250 VAC, 16 A)

NOTE: Additional power cord configurations are
available. The length of the power cords is 2.5 m
(8 ft). For more information, contact an Abbott
Rated power consumption* Maximum of 3000 VA (3 kVA)
Processing module electrical specifications and requirements (i‑series)

Table 19: Processing module electrical specifications and requirements (i‑series)
AC power:*

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• Frequency 47 Hz to 63 Hz

specifications.
Heat dissipation • Idle: 1054 Btu

• Typical running mode: 1634 Btu
NOTE: The system includes one processing module
and one system control module.
Outlet (1):
• Universal IEC 60309 (IP44 Blue) 2P 3W (250 VAC, 16 A)

NOTE: An additional power cord configuration is
available. For more information, contact an Abbott
Rated power consumption* Maximum of 3000 VA (3 kVA)
Optical specifications (c‑series)

Table 20: Optical specifications (c‑series)
Light source Tungsten-halogen lamp

Detector Silicon photodiode array

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Light path length 5 mm ± 0.02 mm

Photometric method Diffraction grating
Reaction cuvette Rectangular glass cuvette
Wavelengths 16 wavelengths (nm): 340, 380, 404, 416, 450, 476,
500, 524, 548, 572, 604, 628, 660, 700, 748, and
804
Photometric range -0.1 Abs to 3.2 Abs (converted to a 10 mm light path
length)
Linearity ≤ ± 2% at 2.0 Abs
Water and liquid waste specifications and requirements

Water and liquid waste specifications and requirements provide a basic overview of the
For additional characteristics that are specific to a processing module, see the appropriate
module type.
Table 21: Water and liquid waste specifications and requirements
Water quality:
• Maximum microbial contamination ≤ 1000 colony-forming units per mL
• Minimum resistivity 1 MΩ • cm at 25°C (77°F)
• Pressure (at the system control module) 10 psi to 90 psi
IMPORTANT: Do not process samples when
maintenance is performed on the purified
water system. After maintenance is
completed, ensure that the pressure is within
specifications.
• Temperature 15°C (59°F) to 30°C (86°F)
Liquid waste configuration (system control Maximum of 2 gravity-fed waste tubes and
module) 2 pressure waste tubes
Drainage port:
• Location Within 3 m (9.5 ft) from the rear of the system
• Height • c‑series ≤ 10 cm (4 in.) above floor level
• i‑series ≤ 50.8 cm (20 in.) above floor level
NOTE: If the drainage port specifications are not NOTE: In a multimodule system, use the
met or if the drain is located in a sink or is specifications for the most restrictive processing
otherwise elevated, the external waste pump module type.
(optional accessory) must be used.

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For the required drainage port specifications of

systems that are connected to a laboratory
automation system (LAS), refer to the LAS vendor
documentation.
Processing module water and liquid waste specifications and requirements (c‑series), page 460
Processing module water and liquid waste specifications and requirements (i‑series), page 460
Processing module water and liquid waste specifications and requirements (c‑series)
Table 22: Processing module water and liquid waste specifications and requirements
(c‑series)
Purified water consumption per processing

module:
• Average 27 L/h
• Maximum (during cuvette wash) ≤ 30 L/h
Liquid waste configuration 2 gravity-fed waste tubes and 1 pressure waste tube
Each waste tube drains to the system control
module waste manifold.
Liquid waste output per processing module:
• Average 30 L/h
• Maximum (during water bath exchange) ≤ 200 L/h
• High-concentration waste ≤ 2.5 L/h
Drainage capacity per processing module ≥ 300 L/h
Processing module water and liquid waste specifications and requirements (i‑series)
Table 23: Processing module water and liquid waste specifications and requirements
(i‑series)
Purified water consumption:

• Average ≤ 10 L/h
• Peak flow rates • ≤ 20 L/h (maximum of 15 min)
• ≤ 30 L/h (maximum of 2 min during the prime
of the wash buffer dilution assembly)
Liquid waste configuration 1 gravity-fed waste tube and 1 pressure waste tube

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Each waste tube drains to the system control

module waste manifold.
Liquid waste output per processing module:
• Average 8 L/h
• Maximum (during the prime of the wash buffer 30 L/h
dilution assembly)
Drainage capacity per processing module 0.5 L/min or 30 L/h for a maximum of 2 min
Environmental specifications and requirements

Table 24: Environmental specifications and requirements
Altitude 30.8 m (100 ft) below sea level to 2590.8 m

(8500 ft) above sea level
Electrical safety parameters:
• Installation category II (overvoltage category)
• Pollution degree 2
Heat dissipation while in a typical running mode See electrical specifications and requirements that
are specific to a module.
Humidity • Relative humidity from 20% through 85%
• Maximum dew point of 22.3°C (72.14°F) at
standard atmospheric pressure
Noise levels:
• Alinity c Does not exceed 55.9 dBA at 1 m from the system
• Alinity i Does not exceed 63.4 dBA at 1 m from the system
Placement • For indoor use only. Do not install the system
near direct sunlight.
• Do not install the system near drafts from
heating and cooling vents.
Storage and transport • Keep dry.
• Fragile: Handle with care.
Temperature during operation 15°C to 30°C (59°F to 86°F)
CAUTION: This equipment is not intended for use in residential environments and may
not provide adequate protection to radio reception in such environments. Do not use this
equipment in close proximity to sources of strong electromagnetic radiation, as this can
interfere with appropriate operation.

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System control module (SCM) electrical specifications and requirements, page 456
Processing module electrical specifications and requirements (c‑series), page 456
Processing module electrical specifications and requirements (i‑series), page 457
Computer and interface specifications

Table 25: Computer and interface specifications
Processor Minimum: Intel Core i7-2600 Class Processor;

3.4 GHz, 8 GB RAM
Hard drive:
• C drive Minimum: 100 GB solid-state hard drive
• D drive Minimum: 100 GB solid-state hard drive
USB flash drive Minimum: 2 GB
NOTE: Do not use a USB flash drive that is
software encrypted with password protection.
Operator interface:
• Monitor LCD (minimum 21 in.)
Speakers are included in the monitor.
• Touchscreen Standard DVI or higher connection including a USB
connector
• Keyboard Not provided. If a keyboard is provided by the user,
the keyboard needs to have a USB connection.
• Mouse Not provided. If a mouse is provided by the user, the
mouse needs to use optical movement technology
with a USB connection.
• Bar code scanner USB connection
Symbologies (bar code types) that can be read:
• Code 128
• Standard Code 39
• Codabar
• Data Matrix ECC 200 (reagents and supplies)
Printer drivers • Brother Mono Universal (PCL)
• Brother Universal (BR-Script3)
• Canon Generic PCL6
• Epson Universal
• HP Universal Printing PCL 6
• Lexmark Universal v2 XL
• Samsung Universal 2

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• Kyocera Classic Universal PCL6

• Kyocera Classic Universal PCL6 (A4)
Ports • USB
• 9-PIN serial
• 2 LAN connections capable of a minimum of 1
Gbps
Host interface:
• Communications mode Bidirectional
• Connections • ASTM - Single TCP/IP
• HL7 - Dual TCP/IP
• Interface reference documents ASTM:
• CLSI LIS01-A2: Specification for Low-Level
Protocol to Transfer Messages Between
Clinical Laboratory Instruments and Computer
Systems
• CLSI LIS2-A2: Specification for Transferring
Information Between Clinical Laboratory
Instruments and Information Systems
HL7:
• HL7 version 2.5.1 Messaging Standard
• HL7 version 2.3.1 Implementation Support
Guide, Appendix C
• IHE Laboratory Technical Framework,
Laboratory Analytical Workflow (LAW) profile
Processing module interface Ethernet
External waste pump specifications and requirements

The external waste pump is an optional component for use with the Alinity ci‑series when a floor
drain is unavailable. The pump moves waste from the waste outlet to an elevated drain.
External waste pump general specifications, page 464
External waste pump electrical specifications and requirements, page 464
External waste pump clearances, page 464

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External waste pump general specifications

Table 26: External waste pump general specifications
Depth 33 cm (13 in.)

Width 33 cm (13 in.)
Height 33 cm (13 in.)
Weight 8 kg (18 lb)
External waste pump electrical specifications and requirements

Table 27: External waste pump electrical specifications and requirements
AC power:
• North America • Voltage: 104 VAC to 126 VAC
• Frequency: 47 Hz to 63 Hz
• International • Voltage: 207 VAC to 253 VAC
• Frequency: 47 Hz to 63 Hz
NOTE: The voltage selector must be set manually.
Circuit breaker that can be reset:

• North America 1.6 A
• Universal 0.8 A
Outlet (1):
• North America NEMA 5-15 three prong (120 VAC, 15 A)
• Universal IEC 320 M grounded (220 VAC to 240 VAC)
External waste pump, page 136
External waste pump clearances

Table 28: External waste pump clearances
Clearance on either side 12.7 cm (5 in.)

(for access)
Clearance in front 22.9 cm (9 in.)
(for access)
Clearance in rear 22.9 cm (9 in.)

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(for access)
Bar code label requirements

Bar code label requirements include information about bar code guidelines and the format, label
length, and placement of bar codes.
1D reagent bar code label requirements (c‑series), page 465
Sample bar code label requirements, page 468
1D reagent bar code label requirements (c‑series)

One-dimensional (1D) reagent bar code label requirements are provided to ensure that 1D
reagent bar code labels meet the recommended guidelines and are correctly affixed to reagent
cartridges.
1D reagent bar code label guidelines (c‑series), page 465
1D reagent bar code label data format (c‑series), page 466
1D reagent bar code label placement (c‑series), page 468
1D reagent bar code label guidelines (c‑series)

Table 29: 1D reagent bar code label guidelines (c‑series)
Component Description
Printer type Use a printer with a minimum resolution of 300 dots per inch (DPI). The
appropriate maintenance of a bar code printer is essential.
NOTE: Laser and ink-jet printers with resolutions that are less than
300 DPI and dot-matrix printers are not recommended to produce
acceptable labels.
Label stock Use a good-quality, white label stock. The black ink used for bar codes
must be compatible with the label stock used for bar codes.
Printed labels must be clean and dry when they are presented to a bar
code reader.
NOTE: The contrast between the bars and the background label must be
the maximum contrast that is possible. For help with increasing the

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contrast, contact the bar code label supplier. If the use of color on the
label is needed, a color band may be used outside the bar code portion
of the label. For optimal performance, use only black bars on a white
background for the bar code portion of the label.
When labels are printed, the system software provides the following
Avery label templates:
• 5520
• L4773
• L7060
Bar code print quality Use labels with an American National Standards Institute (ANSI) grade of
A, B, or C.
Label print quality is an important factor that affects the functionality of
the bar code reader to correctly decode label information. The
performance of the bar code reader can be enhanced by using labels
with an ANSI grade of A, B, or C. Although bar code labels with ANSI
grades lower than C can provide valid reads, the number of no reads is
higher and the possibility of misreads is increased.
NOTE: ANSI document X3.182-1990, Guideline for Bar Code Print Quality,
provides a standardized methodology to measure and grade bar code
print quality. As a usual practice, evaluate all bar code labels according
to this methodology. For help with grading the labels, contact the bar
code label supplier or the print supplier. In addition, commercially
available verifier systems can perform these evaluations.
Symbology The symbology to use on the c‑series is Code 128.

Length Maximum length of the printed bar code is 50 mm (1.97 in.).
Height Minimum height of the printed bar code is 10 mm (0.39 in.).
Quiet zone Minimum quiet zone distance is 5 mm (0.2 in.).
The quiet zone is the distance from the left edge of the label to the first
black bar and from the last black bar to the right edge of the label.
Density Minimum density (narrow bar width) is 7.5 mil (0.19 mm or 0.0075 in.).
1D reagent bar code label data format (c‑series)

Table 30: 1D reagent bar code label data format (c‑series)
Digit Description
1 to 6 Reagent name: A unique six-digit alphanumeric entry is assigned to the reagent.

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Digit Description
NOTE: The reagent name (digits 1 to 6) of the 1D reagent bar code label must be
identical to the name of the corresponding user-defined reagent.
7 to 10 Serial number: A four-digit numeric entry identifies the unique serial number of the
reagent cartridge.
Range: 0000-9999
NOTE: Each cartridge in one lot of reagent must have a unique numeric identifier.
11 to 15 Lot number: A five-digit alphanumeric entry identifies the unique lot number of the
reagent cartridge.
NOTE: The system software creates lot and serial number data for the reagent
cartridge from digits 1 through 6 of the reagent name, digits 11 through 13 of the
reagent lot number, and digits 7 through 10 of the reagent serial number. In the
system software, alpha characters that are used in lot numbers are not case
sensitive.
16 Expiration year: The one-digit numeric entry identifies the year that the reagent
expires.
Range: 0-9
The selection represents the last digit of the year. The range is then interpreted as
1 year before the selection and 8 years in the future. For example, if the current
year is 2003, the following information is applicable:
• A bar code entry of 3 represents an expiration year of 2003.
17 to 18 Expiration week: The two-digit numeric entry identifies the day of the year that the
reagent expires.
Range: 00-52
Examples:
• 00 = Expires at the end of the 7th day of the year
• 52 = Expires at the end of the last day of the year
NOTE: If a value greater than 52 is entered, the reagent expiration is not tracked.

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1D reagent bar code label placement (c‑series)

Table 31: 1D reagent bar code label placement (c‑series)
Orientation With the handle of the reagent cartridge facing to the right side of the
cartridge, the label can be affixed to the R1 reagent bottle. The R1
reagent bottle is the larger bottle and is positioned leftmost in the
cartridge. The printed bars of the label must be vertically oriented.
Placement The top edge of the label must be aligned with the cartridge transport
tab. The left edge of the label must be aligned with the left edge of the
R1 reagent bottle.
Vertical angle The vertical angle of the label must be ±5 degrees.
When the label is not as vertically straight as possible, the bar code
reader may not locate the required quiet zones and the start and stop
characters.
Figure 125: Correct placement of the 1D reagent bar code label (c‑series)
Sample bar code label requirements

Sample bar code label requirements are provided to ensure that sample bar code labels meet
the recommended guidelines and are correctly affixed to sample tubes.

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Sample bar code label guidelines, page 469
SID length, page 470
Sample bar code label placement, page 471
Sample management, page 636
Load samples into sample racks, page 643
Sample bar code label guidelines

Table 32: Bar code label guidelines
Printer type Use a printer with a minimum resolution of 300 dots per inch (DPI). The
appropriate maintenance of a bar code printer is essential.
NOTE: Laser and ink-jet printers with resolutions that are less than
300 DPI and dot-matrix printers are not recommended to produce
acceptable labels.
Printers with resolutions that are less than 600 DPI are not recommended
to produce labels that have a 5.0 mil density (narrow bar width).
Label stock Use a good-quality, white label stock. The black ink used for bar codes
must be compatible with the label stock used for bar codes.
Printed labels must be clean and dry when they are presented to a bar
code reader.
NOTE: The contrast between the bars and the background label must be
the maximum contrast that is possible. For help with increasing the
contrast, contact the bar code label supplier. If the use of color on the
label is needed, a color band may be used outside the bar code portion
of the label. For optimal performance, use only black bars on a white
background for the bar code portion of the label.
Bar code print quality Use labels with an American National Standards Institute (ANSI) grade of
A, B, or C.
Label print quality is an important factor that affects the functionality of
the bar code reader to correctly decode label information. The
performance of the bar code reader can be enhanced by using labels
with an ANSI grade of A, B, or C. Although bar code labels with ANSI
grades lower than C can provide valid reads, the number of no reads is
higher and the possibility of misreads is increased.
NOTE: ANSI document X3.182-1990, Guideline for Bar Code Print Quality,
provides a standardized methodology to measure and grade bar code
print quality. As a usual practice, evaluate all bar code labels according
to this methodology. For help with grading the labels, contact the bar

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code label supplier or the printer supplier. In addition, commercially

available verifier systems can perform these evaluations.
Symbology The following symbologies can be used on the Alinity ci‑series:

• Standard Code 39
• Codabar
• Code 128 (Subsets A, B, and C)
Quiet zone Minimum quiet zone distance is 6.35 mm (0.25 in.).
The quiet zone is the distance from the top edge of the label to the first
black bar and from the last black bar to the bottom edge of the label.
Density Minimum density (narrow bar width) is 5.0 mil (0.127 mm or 0.005 in.).
Ratio (wide to narrow bar) Minimum ratio: 2:1
Maximum ratio: 3:1
Sample bar code label length Generally, a 51 mm label fits a 75 mm sample tube and a 76 mm label
fits a 100 mm sample tube.
Change sample bar code settings, page 200
SID length
The following factors affect the number of characters that can fit on a sample bar code label:
• Sample bar code label length
• Sample bar code label placement
• Symbology
• Density
• Ratio
• Quiet zone
A maximum of 20 characters are permitted on the sample bar code label. However, the
maximum number of readable characters may be less than 20 for some symbologies because of
the overall label length, the narrow bar width, and the ratio.
If a checksum function is enabled when a bar code label (Code 39, Codabar, or Interleaved 2 of
5) is printed, a checksum character is added to the label. The checksum character is usually
added after the last character on the right side of the label and on the left side of the stop
character. The operator-readable portion of the label may or may not display the checksum
character. When a checksum function is used on an Interleaved 2 of 5 bar code label, use a
minimum of four characters.

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Sample bar code label placement

Table 33: Sample bar code label placement
Orientation The label must be perpendicular to the axis of the tube and must be
affixed to the tube in a ladder orientation where the printed bars are
horizontal.
Placement:
• Top • The label must not exceed the top of the tube.
• Bottom • The label must be a minimum of 8 mm from the bottom of the tube.
This placement ensures that the entire label is visible to the bar code
reader when the tube is placed in a sample rack.
Vertical angle The vertical angle of the label must be ±5 degrees.
When the label is not as vertically straight as possible, the bar code
reader may not locate the required quiet zones and the start and stop
characters.
Figure 126: Correct placement of the sample bar code label

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Figure 127: Incorrect placement of the sample bar code label
Legend:
1. Label placement is too low.
2. Label placement exceeds the vertical angle.
3. Label edges are peeled loose.
4. Clear tape covers the label.
5. A flap extends from the label.
Sample specifications and requirements

Sample specifications and requirements include criteria for onboard sample storage, sample cup
and tube specifications, and sample volume requirements. Sample type and sample volume are
assay dependent. For more information about specimen collection, preparation, and storage, see
the assay documentation.
Sample cup and tube specifications and requirements, page 473
Sample volume requirements, page 476

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Onboard sample storage, page 477

Rerun a test or an exception for a specimen or control, page 703
Sample cup and tube specifications and requirements

The following sample cups and tubes are acceptable for use on the Alinity ci‑series.
Figure 128: Alinity ci‑series sample cups

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Figure 129: Alinity ci‑series sample cups used with sample tubes
Measurement Maximum limit

Height 108 mm
Figure 130: Aliquot and primary sample tubes

IMPORTANT: Conical tubes can be used only for c‑series whole blood applications. For sample
cup and tube requirements that are specific to assays, see the assay documentation.

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Measurement Limits
1. Height • Nominal: 75 mm to 100 mm
• Extreme: 72 mm to 102 mm
2. Outside diameter Sample racks with bar code IDs that begin with
letters A through C:
• Nominal: 10 mm to 13 mm
• Extreme: Maximum of 13.2 mm
Sample racks with bar code IDs that begin with
letters E through T:
• Nominal: 10 mm to 16 mm
• Extreme: 9.6 mm to 16.1 mm
3. Inside diameter • Nominal: Not applicable
• Extreme: Minimum of 7.75 mm
NOTE: The use of serum filters in sample tubes is acceptable if the filter opening (inside
diameter) and the filter height meet the sample tube specifications.
Rack IDs that begin with the letter D, I, O, or Q are invalid rack IDs and are not used.
4107 Sample Pipettor LAS Calibration (c‑series), page 879

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Sample volume requirements

Sample volume requirements depend on the sample vessel type, the onboard sample storage
conditions, and the ordered assays. For sample volume information, see the assay
documentation.
The Alinity ci‑series calculates the minimum sample cup volume that is necessary to test a
sample. The sample cup volume is printed on the order list report.
NOTE:
• The minimum sample cup volume for controls and calibrators is valid for the current
inventory on all processing modules in a workstation at the time of the sample order.
• If the minimum sample cup volume is less than 150 μL, the sample must be priority loaded
to avoid concentration effects because of sample evaporation. If the sample is not priority
loaded, a minimum volume of 150 μL is necessary to test the sample.
• To ensure accurate liquid level detection, do not fill the sample cups above the 1400 μL
graduation mark.
• The reliability of assay results cannot be guaranteed if an adequate sample volume is not
used.
• Ensure that the sample volume is adequate so that retesting can be performed if the
samples are loaded on the reagent and sample manager (RSM) and the RSM is configured
to reposition the samples automatically for retesting.
Table 34: Minimum sample volume requirements
Sample cup:
IMPORTANT: Sample cups cannot be used with
whole blood samples on a c‑series because of the
potential for sample probe damage.
• c‑series 50 μL (sample cup dead volume) + 8 μL
(overaspiration volume) + Combined sample volume
of the ordered assays and replicates
NOTE: The overaspiration volume in the sample
probe is dispensed into the wash cup after the
sample is pipetted for an assay in the following
instances:
• The sample requires an onboard dilution.
• The test has a sample volume that is greater
than 15 μL.
• The aspiration is for the second or higher
number replicate (n = 2 or higher) for either an
individual ICT assay [sodium (Na), potassium
(K), or chloride (Cl)] or all three ICT assays
(Na, K, and Cl).

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Each time that one of these actions occurs, an

additional 8 μL overaspiration volume is aspirated
from the sample for the next assay or group of
three ICT assays.
• i‑series 50 μL (sample cup dead volume) + Combined
sample volume of the ordered assays and replicates
Aliquot tube volumes The minimum sample volume must not be less than
8 mm from the bottom of the tube.
Primary tube volumes The minimum sample volume must not be less than
8 mm above the separation point (clot, gel
separator, or plasma or red cell interface) to
prevent contamination of the sample during
aspiration.
Primary tube volumes (whole blood) The maximum sample volume must not be more
than 78 mm above the bottom of the sample tube.
Requirements for handling the specimens, page 814
Order List Report element descriptions, page 1669
Onboard sample storage

The Alinity ci‑series requires a minimum of 150 µL for routine testing of controls and specimens.
This recommendation supports onboard sample storage for 3 hours under average laboratory
conditions without observable concentration effects because of sample evaporation. The
reliability of assay results cannot be guaranteed if the recommendation is not followed.
The following table describes the approximate amount of time required to decrease the weight of
various starting sample volumes by 5% when the weight is measured in sample cups under
different environmental conditions.
The high and low temperatures (30°C and 15°C) were tested with low humidity. An environment
of 25°C and 45% relative humidity (RH) is considered to be representative of average laboratory
conditions.
Table 35: Onboard sample storage
Onboard time 15°C 25°C 30°C

(h) 15% RH 45% RH 15% RH
1 60 µL 60 µL 100 µL
2 70 µL 80 µL 180 µL
3 100 µL 120 µL 280 µL
4 130 µL 160 µL 365 µL
5 160 µL 200 µL 450 µL

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Section 5 Operating instructions
Introduction
This section provides instructions on how to perform normal operating procedures on the
Before operating the system, become familiar with hardware components of the system and with
fundamental principles of the user interface.
System cycle power, start, pause, and stop, page 480
Notepad flyout, page 511
Home screen, page 519
Consumable inventory management, page 561
Reagent and sample management, page 592
Specimen, calibration, and control orders, page 652
Results screen, page 706
Quality control analysis, page 729
Search flyout, page 757
Archive flyout, page 759
Calibration procedures, page 767
Mechanical hazards, page 833

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Operating instructions
System cycle power, start, pause, and stop Section 5
System cycle power, start, pause, and stop

To perform certain tasks, the operator may need to cycle power to the entire Alinity ci‑series, to
the reagent and sample manager (RSM), or to one or more processing modules.
To cycle power, the specific component must be powered off and then must be powered on
after a certain time period has elapsed. After the power is on, a start must be performed to
transition the instrument status to Idle.
Based on the instrument status of the RSM and the processing module, a pause may be
required so that the following tasks can be performed:
• Maintenance and diagnostics
• Component replacement
• Loading of c‑series sample onboard wash solutions
Power on the user interface (UI) computer, page 488
Power off the user interface (UI) computer, page 488
Power on the processing module, page 489
Power off the processing module, page 494
Power on the reagent and sample manager (RSM), page 497
Power off the reagent and sample manager (RSM), page 499
Start the processing module and the reagent and sample manager (RSM), page 500
Pause the processing module, page 500
Pause the reagent and sample manager (RSM), page 501
Stop the processing module and the reagent and sample manager (RSM), page 502
Perform an emergency shutdown, page 502
Long-term shutdown (i‑series), page 505
Cycle power to the system

Required instrument • Processing module: Offline, Stopped, Warming, or Idle
status
• Reagent and sample manager (RSM): Offline, Stopped,
or Idle
NOTE: The instrument status for each processing module and the RSM must be one of the
required statuses to ensure that sample processing is not interrupted.

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Section 5 System cycle power, start, pause, and stop
Perform this procedure to cycle power to the system control module (SCM), the RSM, and one
or more processing modules to reestablish communication among the system components, to
store configuration information, or to troubleshoot the system.
1. On the menu bar, tap the Home icon.
2. On the Home screen, tap Shutdown.
The user interface (UI) computer powers off when the system software completes the
shutdown.
4. Open the SCM front door.
5. Move the SCM power switch downward.
NOTE: When the SCM power switch is turned off, the power is turned off to the RSM for all
processing modules in a multimodule system.
6. Open the front electronics door of each Alinity c processing module in the system.
7. Locate the power switch for each Alinity c processing module.

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Figure 131: Alinity c processing module power switch
8. Locate the main power breaker for each Alinity i processing module.

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Figure 132: Alinity i processing module main power breaker
9. Move the power switch downward to power off each Alinity c processing module.
Power off the main power breaker of each Alinity i processing module.
10. Ensure that each processing module remains powered off for 1 minute.
11. Power on the UI computer.
12. Wait for the Log On screen to display on the UI computer.
13. Move the SCM power switch upward to power on the RSM and the SCM bar code scanner.
14. Move the power switch upward to power on each Alinity c processing module.
Power on the main power breaker of each Alinity i processing module.
NOTE: After the power is turned on, the RSM and the processing modules initialize and the
instrument statuses transition to Stopped.
15. Log on to the system software.
16. To transition the instrument statuses to Idle, start the RSM and each processing module.
17. Close the front electronics door of each Alinity c processing module.

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18. Close the SCM front door.
Log on, page 510
Cycle power to the processing module and the reagent and sample
manager (RSM)
status
or Idle
Perform this procedure to cycle power to the RSM and one or more processing modules to
reestablish communication with the system control module (SCM), to store configuration
information, or to troubleshoot the system.
NOTE: When the SCM power switch is turned off, the power is turned off to the RSM for
each processing module in a multimodule system and for the SCM bar code scanner.

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3. Open the front electronics door of one or more of the processing modules.
4. Locate the processing module power switch for one or more of the processing modules.

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Figure 134: Alinity i processing module power switch
5. Move the processing module power switch downward to power off one or more of the
processing modules.
6. Ensure that each processing module remains powered off for 1 minute.
7. Move the SCM power switch upward to power on the RSM and the SCM bar code scanner.
8. Move the processing module power switch upward to power on one or more of the
processing modules.
NOTE: After the power is turned on, the RSM and one or more of the processing modules
initialize and the instrument statuses transition to Stopped.
9. To transition the instrument statuses to Idle, start the RSM and one or more of the
processing modules.
10. Close the front electronics door of one or more of the processing modules.

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Power on the user interface (UI) computer

Perform this procedure to power on the user interface (UI) computer.
2. Press the power switch on the front of the UI computer.
3. Wait for the Log On screen to display on the UI computer.
4. If the power to the processing module and the reagent and sample manager (RSM) is on,
cycle power to the processing module and the RSM.
NOTE: Use the main power breaker to cycle power to the Alinity i processing module.
If the power to the processing module and the RSM is off, power on the processing module
and the RSM.
Power off the user interface (UI) computer

status
or Idle
Perform this procedure to power off the user interface (UI) computer.
2. On the Home screen, tap Shutdown.

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The UI computer powers off when the system software completes the shutdown.
Power on the processing module

Prerequisite Confirm that the following criteria are met to ensure the
appropriate initialization of communication between the
system components:
• The system control module is powered on and the user
interface is displayed.
• One or more processing modules have been powered off
for a minimum of 1 minute.
Perform this procedure to power on one or more of the processing modules.

NOTE: If only the front power switch of a processing module is off, the reagent carousel power
is maintained.
1. Locate the main power breaker of the processing module.

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Figure 135: Alinity c processing module main power breaker

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2. If the main power breaker of the processing module is off, move the breaker to the ON/I
position.
3. Open the front electronics door of the processing module.
4. Locate the power switch of the processing module.

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5. If the power switch of the processing module is off, move the switch upward to power on the
processing module.
NOTE: After the power is turned on, the processing module initializes and the instrument
status transitions to Stopped.
6. To transition the instrument status to Idle, start the processing module.
7. Close the front electronics door of the processing module.

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Power off the processing module

Required instrument Offline, Stopped, Warming, or Idle
status
NOTE: The instrument status for each processing module must be one of the required statuses
to ensure that sample processing is not interrupted.
Perform this procedure to power off one or more processing modules during component
replacement or troubleshooting.
NOTE: If only the front power switch of a processing module is off, the reagent carousel power
is maintained. To turn off all power to the processing module, move the main power breaker of
the module to the off position.
1. Open the front electronics door of the processing module.
2. Locate the power switch of the processing module.

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3. Move the processing module power switch downward to power off the processing module.
NOTE: To power off all processing modules in a multimodule system, the power must be
turned off separately for each module.
4. To turn off all power to the processing module, perform steps 5, page 495 and 6, page 497.
If the reagent carousel power does not need to be turned off, proceed to step 7, page 497.
5. Locate the main power breaker of the processing module.

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6. Move the main power breaker of the processing module to the OFF/O position to turn off all
power to the processing module.
7. Let the processing module power remain off for a minimum of 1 minute before the power is
turned on again.
8. Close the front electronics door of the processing module.
To power off the Alinity i processing module for more than 7 days, perform a long-term
shutdown.
Power on the reagent and sample manager (RSM)

Prerequisite Confirm that the user interface computer is powered on and
the user interface is displayed to ensure the appropriate

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initialization of communication between the system

components.
Perform this procedure to power on the reagent and sample manager (RSM).
NOTE: The SCM power switch provides power to the RSM.
2. Move the SCM power switch upward.

NOTE: When the SCM power switch is turned on, the power is turned on for the RSM of
each processing module in a multimodule system. After the power is turned on, the RSM
initializes and the instrument status transitions to Stopped.
3. To transition the instrument status to Idle, start the RSM.

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Power off the reagent and sample manager (RSM)

Required instrument Offline, Stopped, Warming, or Idle
status
NOTE: The instrument status for the RSM must be one of the required statuses to ensure that
sample processing is not interrupted.
Perform this procedure to power off the RSM to perform maintenance or troubleshooting
procedures.
1. Open the system control module (SCM) front door.

NOTE: When the SCM power switch is turned off, the power is turned off for the RSM of
each processing module in a multimodule system and for the SCM bar code scanner.

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Start the processing module and the reagent and sample manager
(RSM)
Required instrument Stopped or Idle
status
Perform this procedure to complete the following tasks:
• Initialize a processing module or the reagent and sample manager (RSM) and transition the
instrument status from Stopped to Idle.
• Reinitialize a processing module or the RSM when the instrument status is Idle.
• Prepare for sample processing.

2. On the Home screen, perform one of the following steps:
– Tap one or more of the processing modules or the RSM.
– Tap one or more of the processing modules and the RSM.
3. Tap Start.
Replace the level sensor for Pre-Trigger Solution, Trigger Solution, or Concentrated Wash Buffer
(i‑series), page 1010
Replace the diluted wash buffer level sensor (i‑series), page 1014
Empty the bulk solution reservoirs (i‑series), page 1456
Empty the diluted wash buffer reservoir (i‑series), page 1460
Remove racks from the sample positioners, page 1464
Pause the processing module

Required instrument Running or Processing
status

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Perform this procedure to transition the instrument status of the processing module from Running
or Processing to Idle. The instrument status must be Idle to perform the following tasks:
• Maintenance and diagnostics
• Component replacement
• Loading of c‑series sample onboard wash solutions

2. On the Home screen, tap one or more of the processing modules.
3. Tap Pause.
NOTE: When the processing module is paused, the instrument status of the module transitions to
Pausing. Then, the processing module performs the following steps:
• Completes the aspiration for the test in process and completes one or two additional
aspirations for the sample in process.
• Returns the sample rack to the reagent and sample manager.
• Transitions to Idle status. All scheduled tests remain as scheduled until the instrument status
of the processing module transitions to Idle. After the processing module transitions to Idle
status, all scheduled tests become exceptions.
The instrument status of the processing module transitions to Idle unless the Run button is
selected to initiate a run before the status transitions.
NOTE: Do not lift a front or rear processing center cover before the instrument status of the
processing module transitions to Idle.
Pause the reagent and sample manager (RSM)

Required instrument Running
status
Perform this procedure to transition the instrument status of the reagent and sample manager
(RSM) from Running to Idle. The instrument status must be Idle to perform the following tasks:
• Perform maintenance procedures or diagnostic procedures.
• Remove a rack or cartridge when the status indicator is amber.
• Stop the transportation of samples to one or more of the processing modules.

2. On the Home screen, tap the RSM.

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3. Tap Pause.
NOTE: When the RSM is paused, the instrument status of the RSM transitions to Pausing.
The processing module completes sample aspiration for all scheduled tests and the RSM
returns the racks to their original locations. Scheduled loading and unloading of reagent
cartridges are completed. The instrument status of the RSM transitions to Idle unless the
Run button is selected to initiate a run before the status transitions.
NOTE: Do not lift a front processing center cover before the instrument status of the processing
module transitions to Idle.
Stop the processing module and the reagent and sample manager
(RSM)
Required instrument Running, Processing, or Idle
status
Perform this procedure to transition the instrument status of the system from Running,
Processing, or Idle to Stopped.
3. Tap Stop.
Perform an emergency shutdown

Perform this procedure to shut down the system when an emergency situation occurs.
1. Locate the main power breaker for the system control module (SCM) and all processing
modules.

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Figure 143: SCM main power breaker

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2. Move each main power breaker to the OFF/O position.

3. Unplug the power connector from the power supply.
IMPORTANT: To remove all power to all processing modules and the reagent and sample
manager, unplug the power connector from the power supply for each processing module
and the SCM.
Long-term shutdown (i‑series)

If the Alinity i‑series needs to be shut down for more than 7 days, a long-term shutdown
procedure must be performed. The procedure flushes the system with water and air to remove
bulk solutions from pumps and tubing. The procedure prevents salt buildup, which may cause
damage to the system. Contact an Abbott Laboratories representative to perform the long-term
shutdown procedure.

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Section 5 Log On screen
Log On screen
On the Log On screen, the operator can view the following information:
• System information
• Status information
The operator can log on to the system.
Log On screen element descriptions, page 507
Log on, page 510
Lock the user interface, page 510
Descriptions of access levels, page 172
Log On screen element descriptions

On the Log On screen, the operator can log on to the system and can view system and status
information for all modules.
Log On area
This area is used to enter an operator ID and a four-digit numeric pin to log on to the system.
The system has three types of access levels: General, Supervisor, and Administrator.
Log On Displays elements that are used to enter an operator ID or to

display the identification of the previous operator. The default
logon is Admin (system administrator). The following
elements are available:
, + Done The Plus button displays a box that is

used to enter the operator ID. The
operator ID can contain a maximum of
12 alphanumeric characters. The +
Done button displays the operator ID
that was entered. The button switches
between and + Done.
Four operator logon Display the identification of the last four

buttons operators who logged on to the system.

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Log On screen Section 5
Four circles Indicate the entry of the four-digit PIN.

As each digit of the PIN is entered,
each circle is shaded.
Numeric keypad Displays buttons that are used to enter

the four-digit PIN for the operator ID.
The Clear All button is used to clear all
digits that were entered. The
Backspace button is used clear the
last digit that was entered.
If the system is configured for a
password-controlled logon, the
challenge ID and password must be
configured before the password-
controlled logon is used.
System Information area

Displays the current statuses of tests in process on the system.
Time of Completion Displays the completion time for the last test in process on
the system.
Total Samples Displays the total number of samples that have a status of
Scheduled, Running, or In Process.
Orders Pending Displays the number of specimen orders that have a status of
Pending, Scheduled, Running, or In Process.
Exceptions Displays the number of exceptions that have not been rerun
or released. The number is displayed in red text.
System Status area

Displays badges to indicate the statuses of instruments, reagents, and supplies for all system
modules.
Instrument Status Displays the overall instrument status for all system modules.
icon The instrument status is indicated by the following badges:
Green check mark The instrument status for all modules is

Running or Processing.

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Section 5 Log On screen
Amber circle The instrument status for one or more

modules is Idle, Initializing, Warming,
Pausing, or Maintenance.
Red triangle The instrument status for all modules is

Offline or Stopped.
Reagent Status icon Displays the overall reagent status for all system modules.
The status of reagents loaded on the system is indicated by
the following badges:
Green check mark The reagent status for all modules is

OK, Mixing, Overridden, or Disabled.
Amber circle One or more reagent carousel inventory

items have reached or exceeded the
configured low alert setting.
Red triangle One or more cartridges or racks have a

status of Expired, LLS Error, Empty, No
Assay, Incomplete, BC Fail, or
Undefined.
Supply Status icon Displays the overall status of supplies for all system
processing modules. The status of the supplies is indicated by
the following badges:
Green check mark The status of supply items and waste

containers for all processing modules is
OK.
Amber circle One or more supply items have

reached or exceeded the configured
low alert setting.
Red triangle One or more supply items are empty or

expired, or the waste container is full.
Function button


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Log On screen Section 5
Log on
Perform this procedure to log on to the Alinity ci‑series.
1. If the Log On screen is displayed, proceed to step 2, page 510.
If any other screen is displayed, tap the Lock button .
2. Tap an operator logon button.
If the appropriate operator logon button is not displayed, perform the following steps:
a. Tap the Plus button .
b. Type the operator ID.
c. Tap the + Done button.
3. To display the Home screen, tap the four-digit PIN for the operator ID.
Lock the user interface

Perform this procedure to lock the user interface.
NOTE: When the user interface is locked, the operator is not logged off. Any samples that are in
process generate results with the last logged-on operator ID until a new operator logs on.
• On the screen header, tap the Lock button .

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Section 5 Notepad flyout
Notepad flyout
The Notepad feature allows operators to document information that is posted to each user
account. For example, notes can be created to provide the instrument status, the status of
sample processing, or laboratory procedures and guidelines. Pinned notes cannot be deleted
from the personal view of an operator. The maximum number of notes displayed for all operators
is 99.
In the Notepad flyout, the operator can view all notes.
• Create a note.
• Add a comment to a note.
• Delete notes from the personal view of the operator.
• Pin or unpin notes that the operator created.
The system administrator can pin or unpin any operator notes.
Notepad flyout element descriptions, page 511
Add Note flyout element descriptions, page 513
Add Comment flyout element descriptions, page 513
View a note, page 514
Create a note, page 514
Pin or unpin a note, page 515
Edit a note, page 515
Add a comment to a note, page 516
Delete a note, page 517
Delete all unpinned notes, page 517
Notepad flyout element descriptions

In the Notepad flyout, the operator can document information that is posted to each user
account.
A badge is displayed on the Notepad button when a note for the logged-on operator has not
been viewed. A number from 1 through 99 is displayed on the badge, which indicates the
number of unread notes. After the operator views all unread notes, the badge is removed.

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Notepad flyout Section 5
Elements
Author Displays a drop-down list that is used to filter the list of notes
by the author of the original note. The default is All Users.
After notes are added, a list of notes is displayed under the
Author drop-down list.
When a note is selected, the text of the selected note is
displayed in the note box on the right side of the list of notes.
The note box header displays the name of the selected note
and the date and time that the selected note was last
modified. When no note is selected, the note box header
displays Select a note to view.
Comments Displays comments added to a note.
Function buttons

Add Note Displays the Add Note flyout.
Add Comment Displays the Add Comment flyout.
Pin Pins or unpins the selected note. The button switches

between Pin and Unpin. A pinned note cannot be deleted by
other operators from their personal views.
Delete Deletes the selected note or all notes. The button switches
between Delete and Delete All. Delete All is active when a
note is not selected.
Save Saves the edits when a note is edited.
Cancel Deletes the edits when a note is edited.


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Add Note flyout element descriptions
Elements
Title Displays a box that is used to enter a title for a note.
Note Displays a box that is used to enter the note text.
Function buttons



Add Comment flyout element descriptions
Element
Comment Displays a text box that is used to enter a comment for the
selected note.
Function buttons




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View a note
Perform this procedure to view a note. A blue dot indicates a note or comment that has not been
read.
1. On the screen header, tap Notepad.
2. In the list of notes in the Notepad flyout, tap a note to view.
Notes are displayed in the following order:
a. Pinned notes and comments that have not been read
b. Unpinned notes and comments that have not been read
c. Pinned notes and comments that have been read
d. Unpinned notes and comments that have been read
NOTE: To filter the list by the author of the original note, tap an author in the Author drop-
down list.
Create a note
Perform this procedure to create a note that is displayed to all operators when they are logged
on the system. For example, notes can be created to provide the instrument status, the status of
sample processing, or laboratory procedures and guidelines.
2. In the Notepad flyout, tap Add Note.
3. In the Add Note flyout, tap the Title box and type the title of the note.
4. Tap the Note box and type the note.
NOTE: The author of a note can edit the note until a comment is added to the note. After a
comment has been added, the note cannot be edited.
5. To save the note, tap Done.
To delete the note, tap Cancel. When the confirmation message is displayed, tap Yes.
6. To create a new note, repeat steps 2, page 514 through 5, page 514.
7. To close the Notepad flyout, tap Done.

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Pin or unpin a note

Operator access level • System administrator: Pins or unpins all operator notes
• Operator: Pins or unpins the notes that were created by

the operator
Perform this procedure to pin a note so that the note cannot be deleted by other operators from
their personal views or to unpin a note so that the note can be deleted.
2. In the list of notes in the Notepad flyout, tap a note to pin.
down list.
3. To pin a note, tap Pin.
To unpin a note, tap Unpin.
4. To pin or unpin additional notes, repeat steps 2, page 515 and 3, page 515.
Edit a note
Perform this procedure to edit a note. The author of a note can edit the note until a comment is
added to the note. After a comment has been added, the note cannot be edited.
2. In the list of notes in the Notepad flyout, tap a note to edit.

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down list.
3. In the note box, tap Tap to Edit.
4. Edit the note.
5. To save the edits to the note, tap Save.
To delete the edits to the note, tap Cancel.
6. To edit a different note, repeat steps 2, page 515 through 5, page 516.
Add a comment to a note

Perform this procedure to add a comment to a note. If the original note is still available in the
view of the operator, a badge is displayed on the Notepad button to notify the operator that a
new comment was added.
NOTE: A maximum of 20 comments can be added to each note.
2. In the list of notes in the Notepad flyout, tap a note.
down list.
3. Tap Add Comment.
4. In the Comment box in the Add Comment flyout, type a comment.
5. To save the comment, tap Done.
To delete the comment, tap Cancel. When the confirmation message is displayed, tap Yes.
6. To add a comment to a different note, repeat steps 2, page 516 through 5, page 516.

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Delete a note
Operator access level • System administrator: Deletes pinned notes from the
views of all operators
• Operator: Deletes pinned notes, which were created by
the operator, from the views of all operators and deletes
unpinned notes from the view of the operator
Perform this procedure to delete pinned and unpinned notes. Unpinned notes are deleted from
the view of the operator. Pinned notes are deleted from the views of all operators.
2. In the list of notes in the Notepad flyout, tap a note to delete.
down list.
3. Tap Delete.
4. To delete an additional note, repeat steps 2, page 517 and 3, page 517.
Delete all unpinned notes

Perform this procedure to delete all unpinned notes from the view of the operator permanently.
2. In the Notepad flyout, tap Delete All.

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Section 5 Home screen
Home screen
On the Home screen, the operator can view the following information:
• System information and module status information
• System conditions and module conditions that require an operator response

• Start, run, pause, and stop modules.
• Shut down the computer.
Figure 146: Home screen
Host Connection Status flyout, page 529
Printer Status/Queue flyout, page 532
Alinity PRO Connection Status flyout, page 534
LAS Connection Status flyout, page 534
AbbottLink Connection Status flyout, page 537
Abbott Mail Inbox screen, page 538
Instrument statuses, page 557

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Home screen Section 5
Home screen element descriptions
Menu bar
Alert Center - Alert The red triangle (alert badge) navigates to the Alerts tab in
badge the Alert Center flyout. The number of alert messages in the
Alert Center is displayed next to the alert badge. Alerts are
generated for system problems that require immediate
attention.
Alert Center - The amber circle (notification badge) navigates to the

Notification badge Notifications tab in the Alert Center flyout. The number of
notification messages in the Alert Center is displayed next to
the notification badge. Notifications are generated for system
problems that do not require immediate attention.
Alert Center button Displays the Alert Center flyout.
Home icon Navigates to the Home screen.
Sample Status icon Navigates to the All Samples tab on the Sample Status
screen.
Orders icon Navigates to the All Orders tab on the Orders screen.
Results icon Navigates to one of the following tabs on the Results screen:
• Unreleased tab when no badge is present and the system
is configured for manual or hold release of specimen
results.
• Specimen tab when no badge is present and the system
is configured for automatic release of specimen results.
• Exception tab when an amber badge is present,
indicating that one or more test exceptions have been
generated.
QC icon Navigates to one of the following views:

• The All view on the Quality Control screen when no
badges are present.
• The module-specific view for the lowest numbered
module with a module-specific badge.

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An amber badge is displayed on the QC icon when one or

more quality control (QC) tests completed processing and
generated a Westgard warning.
A red badge is displayed on the QC icon when one or more
QC tests completed processing and are out of range or
generated a Westgard failure.
CAL icon Navigates to one of the following views:

• The All view of the Current tab on the Calibration Status
screen when no badges are present.
An amber badge is displayed on the CAL icon when a

calibration is within 1 hour of expiration.
A red badge is displayed on the CAL icon when a calibration
has expired or failed.
Reagents icon Navigates to one of the following views:

• The All view of the Current tab on the Reagents screen
when no badges are present.
NOTE: A badge can be generated for a reagent on the
reagent and sample manager (RSM). These badges are
not module specific.
An amber badge is displayed on the Reagents icon when a

low alert status is applied to one or more items in the reagent
carousel or when an item in the reagent carousel or on the
RSM is within 1 hour of lot or onboard stability expiration.
A red badge is displayed on the Reagents icon when a
cartridge or rack has a load status error or when a cartridge
or rack with a status other than OK, Mixing, Low Alert, or
Disabled is displayed on the Current tab.
Supplies icon Navigates to the Supplies screen.

If no badges are present, the module 1 view is displayed. If
badges are present, the module-specific view for the lowest
numbered module with a module-specific badge is displayed.
An amber badge is displayed on the Supplies icon when one
or more inventory items have exceeded the configured low
alert setting.

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A red badge is displayed on the Supplies icon when an

inventory item has a status other than OK, Overridden, or Low.
System button Displays a menu of commands. The following list describes

the default menu commands:
Cal/QC Inventory Navigates to the Cal/QC Inventory

screen. The Cal/QC Inventory icon can
be configured to display on the menu
bar.
Procedures Log Navigates to the Procedures Log

screen.
Abbott Mail Navigates to the Abbott Mail screen.
Configure Navigates to the Configure screen. The

Configure icon can be configured to
display on the menu bar.
System Logs Navigates to the System Logs screen.
Utilities Navigates to the Utilities screen.
Operations Manual Displays the online Alinity ci‑series

(Help) Operations Manual. The Operations
Manual (Help) icon can be configured
to display on the menu bar.
Commands configured as icons are not displayed in the

menu.
Procedures icon Navigates to the Maintenance tab, the Diagnostics tab, or

the In Process tab on the Procedures screen.
An amber badge is displayed on the Procedures icon when a
maintenance procedure or a diagnostic procedure that is in
process has a status of "Waiting user response."
A red badge is displayed when a maintenance procedure is
overdue.
Create Order icon Navigates to the Specimen tab on the Create Order screen.

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Screen header
Home/System name Displays the screen title and the configured system name.
? Help button Displays Help from the operations manual for the active
screen.
Notepad button Displays the Notepad flyout. A notification badge showing the
number of unread notes is displayed on the Notepad button
when a note for the logged-on operator has not been viewed.
The badge is removed after all unread notes have been
viewed.
Lock button Locks the screen and displays the Log On screen. The
operator must enter a user name and password to unlock the
screen.
Logged on Displays the user name of the operator logged on the system.
Time Displays the current system time.
Date Displays the current system date.
Software version Displays the current version of software installed on the

system.
Abbott A button Prints a copy of the screen. The screen is printed to the
configured default printer or to a USB flash drive. The
destination of the generated print screen can be configured
on the Configure screen, General tab, Reports screen. The
operator can print the screen to a configured printer or to a
file.
System Status bar

The System Status bar provides system-monitoring information and status information for
devices connected to the system. The following statuses may be displayed on the System
Status bar: Host, Printer, Alinity PRO, LAS, AbbottLink, and Abbott Mail.
Host button Displays the Host Connection Status flyout. The button is
displayed only when the system is configured for the host
computer. The status of the host communication is indicated
by the following button colors:

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Green The system is communicating with the

host and detects no errors.
Yellow The system is establishing a connection

to the host.
Red Communication is unavailable.
Printer button Displays the Printer Status/Queue flyout. The button is

displayed only when the system is configured for a printer.
The status of the printer connection is indicated by the
following button colors:
Green The printer interface detects no errors.
Alinity PRO button Displays the Alinity PRO Connection Status flyout. The button
is displayed only when the system is configured for an Alinity
PRO interface. The status of the Alinity PRO connection is
indicated by the following button colors:
Green The system is communicating with

Alinity PRO and detects no errors.
Red Communication with Alinity PRO has an

error condition.
LAS button Displays the LAS Connection Status flyout. The button is
displayed only when the system is configured for a laboratory
automation system (LAS) interface. The status of the LAS
connection is indicated by the following button colors:
Green The system is communicating with the

LAS and detects no errors.
Yellow The system is connecting to the LAS.
Red Communication with the LAS has an

error condition or is disabled.
AbbottLink button Displays the AbbottLink Connection Status flyout. The button
is displayed only when the system is configured for
AbbottLink. The status of the AbbottLink communication is
indicated by the following button colors:

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Green The system is communicating with

AbbottLink.
Mail button Navigates to the All tab on the Abbott Mail Inbox screen. The
button is displayed only when the system is configured for
AbbottLink. A badge displays the number of new mail items
received since the last time the Abbott Mail Inbox was viewed.
Information area
RSM image Displays the RSM, the RSM name (if configured), and the
current status for the RSM.
Processing module Displays the module type, the module name (if configured),
image the module number, and the current status of the processing
module. A separate image is displayed for each processing
module in the system. The following status updates are
displayed on the processing module image:
• Instrument Status
• Reagent Status
• Supply Status
• QC Status
• Calibration Status
• Maintenance
• Tests In Progress
Instrument Status Displays the current status of the RSM and individual
button processing modules. The instrument status is indicated by the
following colors:
Green The instrument status of the module is

Running or Processing.
Yellow The instrument status of the module is

Idle, Initializing, Warming, Pausing, or
Maintenance.
Red The instrument status of the module is

Offline or Stopped.

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NOTE: The Processing status and the Warming status are not
displayed for the RSM.
Reagent Status button Navigates to the Current tab on the Reagent Status screen
for the module selected. The status of reagents loaded in the
reagent carousel and loading area of the RSM is indicated by
the following colors:
Green The cartridge status is OK, Mixing,

Overridden, or Disabled.
Yellow The volume of one or more reagent

carousel items is below the configured
low alert setting.
Red One or more reagent carousel items

have a cartridge status of Expired, LLS
Error, Empty, No Assay, Incomplete, BC
Fail, Load Error, or Undefined. A
reagent status of Empty triggers a red
status only if no additional tests for the
reagent are present on the module.
Supply Status button Navigates to the Supplies screen for the module selected.
The status of supplies loaded on the system is indicated by
Green The status of all supply items and the

waste container is OK.
Yellow The volume of a supply item is at or

below the configured low alert setting,
the waste container is near capacity, or
the ICT module has exceeded the
warranty period (number of days on the
system or number of samples
processed).
Red A supply item is empty or the waste

container is full.
QC Status button Navigates to the Quality Control Summary screen for the
selected module. The status of the quality control is indicated
by the following colors:

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Green All control results are within the

acceptable range. No Westgard failures
or warnings for the module are present.
Yellow A Westgard warning has occurred on

the module.
Red A control result, lot, or level for the

module is out of range or has a
Westgard failure status.
Calibration Status Navigates to the Current tab on the Calibration Status screen
button for the module selected. The status of current assay
calibrations is indicated by the following colors:
Green All calibrations for onboard reagents

are Active, Pending QC, or In Process.
Yellow One or more calibrations for onboard

reagents are within 1 hour of expiration.
Red One or more calibrations for onboard

reagents have expired or failed, or are
not active.
Maintenance button Navigates to the Maintenance tab or the In Process tab on

the Procedures screen for the module selected. The status of
the system maintenance is indicated by the following colors:
Green All required maintenance procedures

have been performed. Navigates to the
Maintenance tab.
Yellow A maintenance procedure or a

diagnostic procedure is in process and
requires an operator response.
Navigates to the In Process tab.
Red One or more maintenance procedures

are overdue. Navigates to the
Maintenance tab.
Tests In Progress Displays the total number of tests in progress (Scheduled, In

button Process, and Running). If no tests are in progress on the

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module, three dashes are displayed. Navigates to the All

Orders tab on the Orders screen.
Total Samples Displays the total number of samples with a status of

Scheduled, Running, or In Process. Navigates to the Sample
Status screen.
Sample Status button Navigates to the Sample Status screen.
Exceptions Displays the number of exceptions in the Exception tab on

the Results screen that have not been rerun or released.
Navigates to the Exception tab on the Results screen.
Exceptions button Navigates to the Exception tab on the Results screen.
Orders Pending Displays the number of specimen orders with a status of

Pending, Scheduled, Running, or In Process. Navigates to the
All Orders tab on the Orders screen.
Orders button Navigates to the All Orders tab on the Orders screen.
Function buttons
Shutdown Displays a message requesting confirmation to shut down the

system.
Start Initializes and homes the RSM or one or more selected

processing modules, and transitions the instrument status
from Stopped to Idle.
Stop Displays a message requesting confirmation to transition the

instrument status of the RSM or the selected processing
module from Running, Processing, or Idle to Stopped.
Pause Displays a message requesting confirmation to transition the

instrument status of the RSM from Running to Idle or to
transition the instrument status of the selected processing
module from Running or Processing to Idle.
Run Transitions the instrument status of the RSM or the selected

processing module from Stopped, Idle, or Pausing to Running
or Processing (only for c‑series).

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Host Connection Status flyout

In the Host Connection Status flyout, the operator can view the status of the host connection.
• Cancel pending transmissions.
• Enable or disable the host connection.
Host Connection Status flyout element descriptions, page 529
Descriptions of host connection statuses, page 530
Cancel pending transmissions, page 531
Enable or disable the host connection, page 531
Host Connection Status flyout element descriptions

The Host Connection Status flyout provides host communication information.
Elements
Host Type Displays the type of host communication interface: HL7 or

ASTM.
Channel Status Displays the current connection status and the date and time
of the most recent status change for the ASTM channel. The
channel displays one of the following statuses: Connected,
Connecting, Error, or Disabled.
This element is only available when the host communication
interface is ASTM.
Sender Channel Displays the current connection status and the date and time
Status of the most recent status change for the HL7 sender channel.
The channel displays one of the following statuses:
Connected, Connecting, Idle, Error, or Disabled.
interface is HL7.

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Receiver Channel Displays the current connection status and the date and time
Status of the most recent status change for the HL7 receiver
channel. The channel displays one of the following statuses:
Connected, Connecting, Error, or Disabled.
interface is HL7.
Queued Messages Displays the number of messages pending transmission to the

host interface connection.
Message Displays a message code to explain the Error status or the

Disabled host communication status.
Function buttons

Enable Resets the host communication interface.
Disable Disconnects the host communication interface.
Clear Queue Removes all messages pending transmission to the host. The
button is unavailable until messages are waiting to be
transmitted.

Descriptions of host connection statuses

Host connection status information is used to determine if the host connection is enabled or is
disabled.
The following list provides descriptions of the host connection statuses:
Connected The connection is established with the host.
Connecting The system is attempting to establish a connection with the

host.
Idle No connection is established with the host because there are

no messages to send.

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This status is only available for the HL7 sender channel when
the Active Transmit option is configured.
Error No connection is established with the host because of a

communication error.
Disabled Communication with the host is disabled because the operator

disabled the connection or the send message queue is full.
Cancel pending transmissions
Prerequisite The host connection status must be Disabled.
Perform this procedure to clear all queued messages (including results) that are pending
transmission to the host.
2. On the System Status bar of the Home screen, tap Host.
3. In the Host Connection Status flyout, tap Clear Queue.
4. To close the Host Connection Status flyout, tap Done.
User interface (UI) computer corrective action procedures, page 1465
Enable or disable the host connection

Perform this procedure to enable or disable the host connection.
2. On the System Status bar of the Home screen, tap Host.
3. In the Host Connection Status flyout, tap one of the following options:
– Tap Enable to enable the host connection.
– Tap Disable to disable the host connection.
4. To close the Host Connection Status flyout, tap Done.

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Printer Status/Queue flyout

In the Printer Status/Queue flyout, the operator can view a print job in the printer queue and can
delete a print job.
Printer Status/Queue flyout element descriptions, page 532
View a print job in the printer queue, page 533
Delete a print job, page 533
Printer Status/Queue flyout element descriptions

The Printer Status/Queue flyout provides information about the printer status and jobs in the
printer queue for the configured default printer.
Elements
Printer Displays the name of the configured default printer.
Printer Status Displays one of the following statuses for the printer: OK or
Error.
Number of Printer Displays the number of print requests in the printer queue. A
Jobs maximum of 10 printer jobs are allowed in the queue. Print
requests are performed in the order in which they are
received.
Printer Queue Displays information about individual jobs in the printer queue.
Status Displays one of the following statuses for the print request:
Queued, Printing, Error, Deleting, or Out of Paper.
Operator ID Displays the identification of the operator who submitted the

print request.
Date Displays the date and time that the print request was
submitted to the printer queue.
Document Displays the name of the document in the printer queue.
Pages Displays the number of pages for the document in the printer
queue.
Size Displays the size of the document in the printer queue.

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Function buttons

Delete All Deletes all print requests from the printer queue.
Delete Selected Deletes selected print requests from the printer queue.

View a print job in the printer queue

Perform this procedure to view a print job in the printer queue.
2. On the System Status bar of the Home screen, tap Printer.
NOTE: If a printer is not configured, the Printer button is not displayed.
3. In the Printer Status/Queue flyout, view the print job.
4. To close the Printer Status/Queue flyout, tap Done.
Delete a print job

Perform this procedure to delete a print job that is printing, is waiting to be printed, or has
generated a print error.
2. On the System Status bar of the Home screen, tap Printer.
3. In the Printer Status/Queue flyout, perform one of the following options:
– To delete one print job in the printer queue, tap the print job, and then tap Delete
Selected.
– To delete all print jobs in the printer queue, tap Delete All.
4. To close the Printer Status/Queue flyout, tap Done.

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Alinity PRO Connection Status flyout

In the Alinity PRO Connection Status flyout, the operator can view the status of the Alinity PRO
connection.
Alinity PRO Connection Status flyout element descriptions, page 534
Alinity PRO Connection Status flyout element descriptions

The Alinity PRO Connection Status flyout provides Alinity PRO connection information.
Elements
Status Displays one of the following connection statuses for Alinity

PRO: OK or Error.
Last Update Displays the date and time of the last connection status
update.
Message Displays a message code to explain a connection status of

Error.
Function buttons


Alinity PRO Connection Status flyout, page 534
LAS Connection Status flyout

In the LAS Connection Status flyout, the operator can view the status of the laboratory
automation system (LAS) connection.
The operator can enable or disable the LAS connection.

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LAS Connection Status flyout element descriptions, page 535

Descriptions of LAS connection statuses, page 536
Enable or disable the LAS connection, page 536
LAS Connection Status flyout element descriptions

The LAS Connection Status flyout provides laboratory automation system (LAS) connection
information.
Elements
Sender Channel Displays the sender channel status and the date and time that
Status the status was updated. One of the following sender channel
statuses is displayed:
• Connected
• Connecting
• Error
• Disabled
Receiver Channel Displays the receiver channel status and the date and time
Status the status was updated. One of the following receiver channel
statuses is displayed:
• Connected
• Connecting
• Error
• Disabled
Queued Messages Displays the number of messages pending transmission to the

LAS connection.
Message Displays a message code to explain an error with the sender

channel or the receiver channel, or to explain the disabled
LAS communication.
Function buttons

Enable Resets the LAS communication interface.

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Disable Disconnects the LAS communication interface.

Descriptions of LAS connection statuses

Laboratory automation system (LAS) connection status information is used to determine if the
LAS connection is connected, is connecting, has produced an error, or is disabled.
The following list provides descriptions of the LAS connection statuses:
Connected The LAS sender channel and the LAS receiver channel are
connected.
Connecting The LAS sender channel is connecting or the LAS receiver

channel is connecting, and neither channel has produced an
error.
Error The LAS sender channel or the LAS receiver channel has
produced an error.
Disabled The LAS communication is disabled.
Enable or disable the LAS connection

Perform this procedure to enable or disable the laboratory automation system (LAS) connection.
2. On the System Status bar of the Home screen, tap LAS.
3. In the LAS Connection Status flyout, tap one of the following options:
– Tap Enable to enable the LAS connection.
– Tap Disable to disable the LAS connection.
4. To close the LAS Connection Status flyout, tap Done.

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AbbottLink Connection Status flyout

In the AbbottLink Connection Status flyout, the operator can view the status of the AbbottLink
connection and can restart AbbottLink.
AbbottLink Connection Status flyout element descriptions, page 537
Restart AbbottLink, page 537
AbbottLink Connection Status flyout element descriptions

The AbbottLink Connection Status flyout provides AbbottLink connection information.
Elements
Status Displays the connection status for AbbottLink: Connected or

Disconnected.
Last Update Displays the date and time of the last connection status
update.
Function buttons

Restart Restarts the AbbottLink program on the user interface

computer.

Restart AbbottLink
Perform this procedure to restart the AbbottLink software on the user interface computer.
2. On the System Status bar of the Home screen, tap AbbottLink.
3. In the AbbottLink Connection Status flyout, tap Restart.
The AbbottLink software stops and restarts.

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4. To close the AbbottLink Connection Status flyout, tap Done.
Abbott Mail Inbox screen

On the Abbott Mail Inbox screen, the operator can view Abbott Mail items and Abbott Mail
documentation.
• Accept Abbott Mail items.
• Delete Abbott Mail items.
• Request assay files.
• Request calibration data files.
• Decline system updates.
Abbott Mail Inbox screen, All tab element descriptions, page 539
Abbott Mail Inbox screen, Assay Files tab element descriptions, page 540
Abbott Mail Inbox screen, Assay Inserts tab element descriptions, page 541
Abbott Mail Inbox screen, System Updates tab element descriptions, page 542
Abbott Mail Inbox screen, Calibrator Data tab element descriptions (c‑series), page 543
Abbott Mail Inbox screen, Search flyout element descriptions, page 545
Manual File Request screen, page 546
Assay file mail description, page 550
Assay insert mail description, page 550
System update mail description, page 551
Calibrator data mail description (c‑series), page 551
Descriptions of mail statuses, page 552
Descriptions of view statuses, page 552
View Abbott Mail items, page 552
View or print Abbott Mail documentation, page 553
Accept Abbott Mail items, page 553
Delete Abbott Mail items, page 554
Manually request assay files, page 554
Manually request calibrator data files, page 555
Decline Abbott Mail system updates, page 556

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Abbott Mail Inbox screen, All tab element descriptions

The All tab displays the new and viewed mail for all categories of mail items received in the
Abbott Mail Inbox. Mail items can be filtered into four categories (Assay Files, Assay Inserts,
System Updates, and Calibrator Data) by selecting the appropriate tab.
Elements
View Status Displays a status to show whether the mail is new or has been
viewed. The mail item displays one of the following statuses:
New or Viewed.
Mail Status Displays the status of each item in the Abbott Mail Inbox. The
mail item displays one of the following statues:
• New
• Update
• Error
Category Displays the type of mail item in the Abbott Mail Inbox. The
mail item is associated with one of the following four
categories:
• Assay Files
• Assay Inserts
• System Updates
• Calibrator Data
Date/Time Displays the date and time that the mail item was received.
Subject Displays a description of the mail item.
Number Displays a number identifier for the mail item if applicable.
Revision Displays the version of the document for mail items with
revisions.
Function buttons
Install Assay Navigates to the Install/Uninstall Assays screen.
Import Cal Lot Navigates to the Calibrator Set screen.

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Request Navigates to the Manual File Request screen.
Accept Used to remove assay inserts from the Abbott Mail Inbox or to
make selected mail items available for installation or import.
Delete Deletes the selected mail item.
Abbott Mail Inbox screen, Assay Files tab element descriptions

The Assay Files tab displays the new and viewed assay file mail items received in the Abbott
Mail Inbox.
Elements
New or Viewed.
• New
• Update
• Error
List Number Displays the list number associated with the assay file.
Revision Displays the assay file version.

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Function buttons
Install Assay Navigates to the Install/Uninstall Assays screen.
Request Assay Navigates to the Manual File Request screen.
Accept Used to make the selected mail item available for installation.
Assay files with a version number less than or equal to the
installed assay file or a version currently available to install
are not available for installation.
Abbott Mail Inbox screen, Assay Inserts tab element descriptions

The Assay Inserts tab displays the new and viewed assay file mail items received in the Abbott
Mail Inbox.
Elements
New or Viewed.
mail item displays one of the following statuses:
• New
• Update
• Error

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Commodity Number Displays the commodity number assigned to the assay insert.
Revision Displays the assay insert version.
Function buttons
Accept Used to set the assay insert status to Current on the Reagent
Cartridge Details screen and removes the mail item from the
Abbott Mail Inbox.
Abbott Mail Inbox screen, System Updates tab element descriptions

The System Updates tab displays the new and viewed system update notifications and system
software updates received in the Abbott Mail Inbox.
Elements
New or Viewed.
• New

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• Update
• Error
TSB Number Displays the technical service bulletin (TSB) number for the
mail item.
Priority Displays the priority level of the TSB. The mail item displays
one of the following statuses: Mandatory or Optional.
Function buttons
System Updates Navigates to the System Updates screen.
Accept Used to make hardware and software system updates

available for installation and removes the items from the
Abbott Mail Inbox.
Decline Used to decline the download of system update mail items.
Abbott Mail Inbox screen, Calibrator Data tab element descriptions (c‑series)
The Calibrator Data tab displays the new and viewed calibrator data mail items received in the
Abbott Mail Inbox.

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Elements
New or Viewed.
• New
• Update
• Error
Lot number Displays the calibrator lot number.
List number Displays the calibrator list number.
Expiration Date Displays the calibrator expiration date.
Function buttons
Import Cal Lot Navigates to the Calibrator Set screen.
Request Calibrator Navigates to the Manual File Request screen.
Accept Used to make the selected mail calibrator data item available
for import.

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Abbott Mail Inbox screen, Search flyout element descriptions

In the Search flyout of the Abbott Mail Inbox screen, the operator can enter specific data that is
used to filter the data on the screen.
Elements
Mail Status Displays a check box for each mail status. The following mail
status check boxes may be displayed:
• New
• Update
• Error
View Status Displays a check box for each view status. The following view
status check boxes may be displayed:
• New
• Viewed
Category Displays a check box for each category option. The following
category check boxes may be displayed:
• Assay Files
• Assay Inserts
• Updates
• Calibrator Data
NOTE: This element is displayed only on the All tab.
Subject Displays a text box that is used to enter the subject of the
mail item.
Number Displays a text box that is used to enter the number of the
mail item.
Date From Displays a text box that is used to enter a search start date.
To enter the search start date, tap the calendar inside the
box. To configure the month and year, tap the Left Arrow or
Right Arrow button, and then tap the day.

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To Displays a text box that is used to enter a search end date.

To enter the search end date, tap the calendar inside the box.
To configure the month and year, tap the Left Arrow or Right
Arrow button, and then tap the day.
Start Time Displays a spin box that is used to enter a search start time.
To enter the search start time, use the system-configured
format (HH:MM) and type the time in the box or tap the Up
Arrow and Down Arrow buttons. If the system is configured
for the 12-hour clock format, tap the AM or PM button to
configure the time of day.
End Time Displays a spin box that is used to enter a search end time.
To enter the search end time, use the system-configured
Function buttons



Descriptions of mail statuses, page 552
Descriptions of view statuses, page 552
Manual File Request screen

On the Manual File Request screen, the operator can view manual requests for assay files and
clinical chemistry assay calibrator data. The screen displays one pending request and the last
five completed requests.
The system administrator can use an AbbottLink connection to request manually the assay files
to send to the system software.

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Manual File Request screen, Assay Files tab element descriptions, page 547
Manual File Request screen, Calibrator Data tab element descriptions (c‑series), page 548
Requested Categories flyout element descriptions, page 549
Descriptions of assay file request statuses, page 549
Manual File Request screen, Assay Files tab element descriptions

On the Assay Files tab, the operator can manually request the immunoassay and clinical
chemistry assay files to be downloaded.
Elements
i‑series Displays the immunoassay assay categories.
c‑series Displays the clinical chemistry assay categories.
Request Status Displays information about the status of the manual file
request. A maximum of five manual file requests are
displayed.
Date/Time Displays the date and time that the assay file was requested,
timed out, or was completed.
Operator ID Displays the identification of the operator who requested the

file.
Items Requested Displays the list of assay categories that was requested. If
one category is selected, the name of the category is
displayed. If multiple assay categories are selected, the
number of categories selected is displayed.
Status Displays the status of the manual file request.

One of the following statues is displayed:
• Pending
• Complete
• Expired
• Failed

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Message Displays more information about the status of the manual file
request.
Function buttons
Done Saves changes and displays the previously viewed screen or

closes the flyout.
Request Assay Used to request assay file downloads for the selected assay
categories.
Details Displays the Requested Categories flyout.
Manual File Request screen, Calibrator Data tab element descriptions (c‑series)
On the Calibrator Data tab, the operator can manually request the clinical chemistry calibrator
value assignment data to be downloaded.
Elements
Request Status Displays information about the status of the manual file
request. A maximum of five manual file requests are
displayed.
Date/Time Displays the date and time that the file was requested, timed
out, or was completed.
Operator ID Displays the identification of the operator who requested the

file.
Items Requested Displays the list of clinical chemistry calibrator value
assignment data that was requested.
Status Displays the status of the manual file request.
One of the following statues is displayed:
• Pending
• Complete

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• Expired
• Failed
Message Displays more information about the status of the manual file
request. Displays the number of calibrator data files that were
downloaded or the number of file errors if applicable.
Function buttons

closes the flyout.
Request Calibrator Used to request downloads of the clinical chemistry calibrator

value assignment data.
Requested Categories flyout element descriptions

In the Requested Categories flyout, the operator can view requested assay categories when
multiple categories are selected.
Elements
Categories Displays a list of the requested assay categories.
Function buttons

closes the flyout.

Descriptions of assay file request statuses

Assay file request status information is used to monitor the status of the requested download.

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The following list provides descriptions of the assay file request statuses. The statuses are
described in the order in which they are sorted:
Pending The request is in process.

The download speed capability of the laboratory affects the
amount of time needed to process a request. The status of a
request for an Abbott Mail item can remain as Pending for a
maximum of 24 hours.
Completed The request is completed.
Expired The request was not received within the 24-hour time-out.
Failed An error occurred and the request was not completed.
Assay file mail description

Abbott Mail allows assay files to be sent automatically or manually to the system software. When
a new assay file is needed on the system, the system administrator can use an AbbottLink
connection to request the new assay file to send to the system software. After the new assay file
is installed, the system software checks weekly for any updates to the assay file. If an updated
assay file is available, the updated assay file is sent automatically to the Abbott Mail Inbox
screen. The system administrator needs to review the assay file documentation before the
updated assay file is installed. If the assay file update requires specific reagents, the system
administrator needs to wait until the appropriate reagents are available before the updated assay
file is installed.
Assay insert mail description

Abbott Mail allows assay inserts to be sent automatically to the system software. When a new
reagent lot is loaded on the system, the system software uses the new reagent lot number to
request a new assay insert through an AbbottLink connection. AbbottLink determines if the new
reagent lot requires a new assay insert.
If a new assay insert is required, the new assay insert is downloaded to Abbott Mail and is
assigned to the new reagent lot in the reagent cartridge details. The status of the assay insert
remains as New until the system administrator reviews and accepts the assay insert in Abbott
Mail.
If the reagent lot uses the current assay insert, the current assay insert is assigned to the new
reagent lot.

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System update mail description

Abbott Mail allows system update notifications and system software updates to be sent to the
system software when new updates are available for installation. System updates are tracked as
technical service bulletins.
The following list provides the categories of Abbott Mail system updates:
Hardware notifications A hardware update is available to install on the system. An

Abbott Laboratories representative schedules and installs the
hardware update.
Software notifications A software update is available to install on the system, but the
software installer has not been downloaded. When the
software notification is accepted, the software installer is
downloaded to the system and is available for installation.
Software notifications The software notification and the software installer are
and installer downloaded to the system. When the software notification is
accepted, the software is available for installation.
Calibrator data mail description (c‑series)

Abbott Mail allows c‑series calibrator data to be sent automatically or manually to the system
software. When new calibrator sets require calibrator data to be imported to the system, the
system administrator can use an AbbottLink connection to request the calibrator data files to
send to the system software. After the calibrator data is imported, the system software checks
weekly for any calibrator data that is associated with new lot numbers for each calibrator set.
When calibrator data is requested for a new calibrator set that has not been configured with a
calibrator lot number, all available calibrator lot number data is downloaded to the system.
When calibrator data is requested for an existing calibrator set that has been configured with
one or more calibrator lot numbers, only the calibrator lot number data that is newer than the
configured data is sent to the system software.

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Descriptions of mail statuses

Mail status information is used to determine if an Abbott Mail item is new, is updated, or has
produced an error.
The following list provides descriptions of the mail statuses. When the Mail Status column
header is selected, the statuses are sorted in the following order:
Error An error occurred when the mail item was downloaded from
AbbottLink.
New The mail item is not installed on the system
Update The mail item is a newer version than the mail item that is
Descriptions of view statuses

View status information is used to determine if an Abbott Mail item has been previously viewed.
The following list provides descriptions of the view statuses. The statuses are described in the
order in which they are sorted:
New The mail item has not been viewed by an operator.
Viewed The mail item has been viewed by an operator.
View Abbott Mail items

Perform this procedure to view new and unaccepted Abbott Mail items.
2. On the System Status bar of the Home screen, tap Mail.
The All tab of the Abbott Mail Inbox screen displays new and unaccepted mail items.
3. To filter the list of mail items on the Abbott Mail Inbox screen, tap a tab (or tap Search).

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View or print Abbott Mail documentation

Perform this procedure to view or print Abbott Mail documentation. The documentation includes
assay inserts, system update information, assay file information, and calibrator value assignment
information.
3. In the list of mail items on the All tab of the Abbott Mail Inbox screen, tap one or more items
(or tap Select All).
4. Tap Print.
5. Under Report Selection in the Print flyout, tap the documentation type that is associated
with the mail item to print.
7. To browse through the document, use the Page toolbar.
11. If more than one document was selected, tap Previous or Next to view the previous or next
document.
To return to the Abbott Mail Inbox screen, tap Done.
Reagents screen, page 608
Accept Abbott Mail items
Perform this procedure to accept Abbott Mail items. When Abbott Mail items are accepted, files
are available for installation or assay inserts are designated as reviewed by the system
administrator, and the items are removed from the Abbott Mail Inbox screen.
NOTE: Thoroughly review the Abbott Mail documentation of the item before accepting the item.

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NOTE: To filter the list of mail items, tap Search.
4. Tap Accept.
Delete Abbott Mail items
Perform this procedure to delete the following Abbott Mail items:

• Assay files that are not wanted for installation
• Calibrator value data files that are not wanted for installation
• Assay inserts that have a mail status of Error
• System update files that have a mail status of Error

NOTE: To filter the list of mail items, tap Search.
4. Tap Delete.
Manually request assay files
Perform this procedure to request new assay files manually. When new assay files are
requested, all assays files that are not installed or are not available to be installed are
downloaded for each assay category that is selected.
NOTE: Only one active request at a time can be performed. If an automatic request or a manual
request for a file is pending, a new request cannot be initiated.

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3. On the Abbott Mail Inbox screen, tap Request.
4. On the Assay Files tab of the Manual File Request screen, tap each assay category that
contains the assay files to download.
NOTE: An individual assay file cannot be requested to download. When new assay files are
requested, all assays files that are not installed or are not available to be installed are
downloaded for each assay category that is selected. After the assay files are downloaded,
any file that is not needed can be deleted from the Abbott Mail Inbox screen.
5. Tap Request Assay.
NOTE: The download speed capability of the laboratory affects the amount of time needed
to process a request. The status of an assay file request can remain as Pending for a
maximum of 24 hours.
6. To return to the Abbott Mail Inbox screen, tap Done.
Assay file mail description, page 550
Manually request calibrator data files
Perform this procedure to request new calibrator data files manually. When new calibrator data
files are requested, all calibrator data files that are not installed or are not available to be
installed are downloaded.
NOTE: Only one active request at a time can be performed. If an automatic request or a manual
request for a file is pending, a new request cannot be initiated.
3. On the Abbott Mail Inbox screen, tap Request.
4. On the Manual File Request screen, tap the Calibrator Data tab.
5. On the Calibrator Data tab of the Manual File Request screen, tap Request Calibrator.
NOTE: When new calibrator data files are requested, all calibrator data files that are not
installed or are not available to be installed are downloaded. After the calibrator data files
are downloaded, any file that is not needed can be deleted from the Abbott Mail Inbox
screen.

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The download speed capability of the laboratory affects the amount of time needed to
process a request. The status of a file request can remain as Pending for a maximum of 24
hours.
6. To return to the Abbott Mail Inbox screen, tap Done.
Calibrator data mail description (c‑series), page 551
Decline Abbott Mail system updates

NOTE: The system administrator cannot decline mandatory
updates.
Perform this procedure to decline a system update that is not wanted. A system update that has
been downloaded successfully cannot be deleted. A system update that is declined is removed
from the Abbott Mail Inbox screen.
NOTE: Thoroughly review the system update documentation before declining the system update.
3. On the Abbott Mail Inbox screen, tap the System Updates tab.
4. In the list of system updates on the System Updates tab, tap one or more updates (or tap
Select All).
NOTE: To filter the list of system updates, tap Search.
5. Tap Decline.
NOTE: The system administrator cannot decline mandatory updates.
6. In the Comment box in the Reason to Decline System Update flyout, type a reason to
decline for each system update.
NOTE: To decline a system update, a comment must be entered.
7. To confirm the decline of the system update, tap Done.
To cancel the decline of the system update and return to the Abbott Mail Inbox screen, tap
Cancel.

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Instrument statuses
Instrument status refers to the operational modes of the Alinity ci‑series. The processing modules
and the reagent and sample manager (RSM) have the following instrument statuses:
Table 36: Instrument statuses
Status Description
Offline Indicates when the processing module is not communicating with the
system control module (SCM).
This status is displayed for the following conditions:
• Power to the processing module is off.
• Power to the processing module has been turned on, but
communication between the module and the SCM has not been
reestablished.
• Communication failure between the processing module and the SCM
has occurred because of a software error or a system error.
Stopped Indicates when the processing module is turned on and is communicating
with the SCM.
• Power to the processing module is on, but Start on the Home screen
has not been selected.
• Stop on the Home screen was selected.
• A diagnostic procedure has completed.
• A procedure has completed with an error.
• A fatal error was detected during assay processing.
Start on the Home screen must be selected to initialize the processing
module and to transition the status to Idle.
Initializing Indicates a temporary status that occurs when Start or Run on the Home
screen is selected.
After initialization is completed, the status transitions to Running,
Processing, or Idle based on whether Start or Run on the Home screen
was selected. Initialization is specific to a module. Based on the module,
the following functions are performed:
• c‑series • Initialization after Start is selected:
– Confirms that the volume of water dispensed from the cuvette
washer is adequate
• Initialization after Start or Run is selected:
– Homes the motors
– Confirms that processing center covers are closed
– Verifies that the reagent carousel inventory is adequate
– Confirms that racks and cartridges are not located on the
reagent positioner
– Confirms that the volume of the bulk solutions is adequate
– Confirms that the volume of the sample onboard wash solutions
is adequate
• Initialization after Run is selected:

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Status Description
– Washes the probes
– Washes the cuvettes
– Verifies that the supply inventory is adequate
• i‑series • Initialization after Start or Run is selected:
– Homes the motors
– Confirms that processing center covers are closed
– Confirms that the RV unloader is in the correct position
– Performs a vacuum check
– Verifies that the reagent carousel inventory is adequate
reagent positioner
• Initialization after Run is selected:
– Washes the pipettor probes
– Starts the mixing of the microparticles
– Verifies that the supply inventory is adequate
– Performs a background check
– Fills the process path load lane with clean reaction vessels
(RVs)
– Clears RVs from the pretreatment path and adds clean RVs
• RSM • Initialization after Start or Run is selected:
– Homes all moving parts
– Confirms that front processing center covers are closed for
each processing module
– Confirms that the bar code reader is functioning correctly
– Homes the sample positioner for each processing module
sample positioners or the RSM transport
Warming Indicates when the processing module has completed initialization but
has not reached the required temperature.
NOTE: This status is not displayed for the RSM.
Idle Indicates when the processing module has successfully completed

initialization and is ready to accept a run request.
• Start is initiated and is completed (including temperature
initialization).
• Pausing status is completed.
Running Indicates when the processing module has successfully completed
initialization and is ready to process tests.
• Run on the Home screen was selected.
• Tests have completed processing, but Pause or Stop on the Home
screen has not been selected.
Processing Indicates when the processing module is actively processing tests.
For c‑series, this status is displayed after Run on the Home screen is
selected and initialization is completed. During this time, cuvettes are
washed and filled with water. If a sample is not loaded on the RSM, the
module status transitions to Running after these activities are completed.

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Status Description
NOTE: This status is not displayed for the RSM.
Pausing Indicates when the processing module is not aspirating samples and is
completing assay processing before the module status transitions to Idle
or Stopped.
The module status transitions to Idle for the following conditions:
• Pause on the Home screen was selected.
• Supply inventory is insufficient.
When an error is detected during assay processing, the module status
Maintenance Indicates when a maintenance procedure or a diagnostic procedure is in
process on the processing module.
Instrument status transition, page 559
Instrument status transition

The processing module has several types of instrument statuses. The following tables describe
the progression of instrument statuses from Offline to Running and the approximate duration of
each transition.
NOTE: When Run is selected for multiple processing modules, if any module produces an error,
the reagent and sample manager transitions to its original status before the run request is
performed.
Table 37: Alinity c‑series
Starting status Function Transitional status Duration of Ending status

transition
(minutes)
Offline Power on the None 1 Stopped
module.
Stopped Tap Start. Initializing 3 Idle
Stopped Tap Run after Initializing 6 Processing
loading a sample.
Idle Tap Run after Initializing 4 Processing
loading a sample.
Idle Tap Run without Initializing 21* Processing
loading a sample.
Running Load a sample. None Immediate Processing
Processing Tap Pause. Pausing 0 to 15 Idle

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transition
(minutes)
(Sample processing
is completed.)
Running Tap Pause. Pausing Immediate Idle
* The number of cuvettes that are washed and filled with water is 187.
Table 38: Alinity i‑series

transition
(minutes)
Offline Power on the None 3 Stopped
module.
Stopped Tap Start. Initializing 4 Idle
Stopped Tap Run. Initializing 7 Running
Idle Tap Run. Initializing 4 to 7* Running
Running Load a sample. None Immediate Processing
Processing Tap Pause. Pausing 0 to 45 Idle
(Sample processing
is completed.)
Running Tap Pause. Pausing Immediate Idle
* If the pretreatment path is repopulated with reaction vessels, the duration of initialization is
7 minutes.

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Section 5 Consumable inventory management
Consumable inventory management

Consumable inventory management includes procedures to prepare and replenish supplies and
to empty waste. Use the Supplies screen to view and manage in-use supply inventory.
Before performing sample processing, verify that onboard consumable inventory is adequate.
Supplies screen, page 561
Cal/QC Inventory screen, page 587
Supplies screen
On the Supplies screen, the operator can view the following information:
• c‑series
– Percentage of bulk solutions
– Percentage of onboard solutions in the sample wash solution area
– Status of the liquid waste in the high-concentration waste bottle
– Status of the ICT module
• i‑series
– Percentage of bulk solutions
– Status of the reaction vessel (RV) waste
– Status of RVs

• c‑series: Update the inventory for bulk solutions, onboard solutions, the liquid waste, and the
ICT module.
• i‑series: Update the inventory for bulk solutions, RVs, and the RV waste.
NOTE: The c‑series and the i‑series calculate the supply volume and the percent-remaining
information on required tests for samples that have been scheduled on the reagent and sample
manager.
Supplies screen, Supply Details flyouts for Alkaline Wash, Acid Wash, and ICT Reference element
descriptions (c‑series), page 567
Supplies screen, Supply Details flyout for ICT Module element descriptions (c‑series), page 569

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Consumable inventory management Section 5
Supplies screen, Supply Details flyouts for Acid Probe Wash and Detergent A element
descriptions (c‑series), page 570
Supplies screen, Supply Details flyout for Liquid Waste element descriptions (c‑series), page
570
Supplies screen element descriptions (i‑series), page 571
Supplies screen, Supply Details flyouts for Pre-Trigger, Trigger, and Wash Buffer element
descriptions (i‑series), page 574
Supplies screen, Supply Details flyout for RVs element descriptions (i‑series), page 575
Supplies screen, Supply Details flyout for RV Waste element descriptions (i‑series), page 576
Solutions used in daily operations (i‑series), page 578
Verify the supply and waste inventory, page 579
Replace bulk solutions and update the inventory, page 579
Replace sample onboard wash solutions and update the inventory (c‑series), page 581
Remove the RV waste and update the inventory (i‑series), page 584
Replenish reaction vessels (RVs) and update the inventory (i‑series), page 586
Replace the ICT module or the ICT probe (c‑series), page 952
Supplies screen element descriptions (c‑series)
Elements
Module bar Used to select an individual module to view supply status

information.
Alkaline Wash area, Acid Wash area, ICT Reference area

The following statuses may be displayed in the Alkaline Wash area, the Acid Wash area, and
the ICT Reference area:
• Bottle empty: The bottle located in the bulk solution storage area is empty.
• Confirm bottle replaced: The bottle located in the bulk solution storage area was replaced
but has not been confirmed in the software.
• Transfer in process: The bulk solution from the bulk solution bottle located in the bulk
solution area is being transferred to the bulk solution reservoir.
Status bar The Alkaline Wash area and the Acid Wash area display a
graphical representation of the status and total remaining
supply. The ICT Reference area displays a graphical
representation of the status and total remaining supply only if

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the c‑series is configured to use the ICT module. Statuses are

indicated by the following colors:
1. Green = OK
2. Yellow = Low Level or Overridden
3. Red = Empty, Lot Expired
When an item meets the criteria for more than one status, the
higher number status is applied to the item. For example, an
item that is both Low Level and Lot Expired is displayed as Lot
Expired.
Total Remaining Estimated percent of bulk solution available in both the

reservoir and bulk solution storage area. The total remaining
volume includes the reservoir bottle and the bulk solution
bottle volumes minus the solution volume needed for tests
that have been scheduled but not yet processed. The color-
coded indicator changes colors as follows:
Green The supply item percent remaining is

above the low alert setting.
Yellow The supply item percent remaining is at

or below the low alert setting.
Red The supply item percent remaining is

zero.
Replaced button Used to confirm bottle replacement when the bar code
scanner is not used.
Update button Displays the Supply Details flyout.
Currently in Use Displays information about the solution contained in the

reservoir.
Expiration Displays the expiration date for the bulk solution currently in
use. The color-coded indicator changes colors as follows:
Green The supply item has not yet exceeded

the lot expiration.
Yellow The supply item is within 8 hours of

exceeding the lot expiration.

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Red The supply item has exceeded the lot

expiration.
Lot Displays the lot number for the solution currently in use.
Stability Days Displays the number of days that the bulk solution has been
on the system. The color-coded indicator changes colors as
follows:

the onboard stability.

exceeding the onboard stability.
Red The supply item has exceeded the

onboard stability.
The indicator is yellow when the supply item status has been
overridden.
ICT Module area
Status bar Displays a graphical representation of the ICT module status

and the warranty period (number of days on the system and
number of samples processed) only if the c‑series is
configured to use the ICT module. Statuses are indicated by
1. Green = OK
2. Yellow = Overridden, Exceeded
3. Red = Lot Expired, Update Required
higher number item status is applied. For example, an item
that is both Exceeded and Lot Expired is displayed as Lot
Expired.
Expiration Displays the expiration date for the ICT module currently in

the serial number expiration.

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exceeding the serial number expiration.

serial number expiration.
SN Displays the serial number of the ICT module.
Days on Board Displays the number of days that the ICT module has been
installed. The color-coded indicator changes to yellow when
the number of days on the system exceeds 90 days.
Samples Processed Displays the number of ICT samples processed. The color-
coded indicator changes to yellow when the number of
samples processed exceeds 20,000 samples.
Acid Probe Wash area, Detergent A area
Status bar Displays a graphical representation of the status and total

remaining supply. Statuses are indicated by the following
colors:
1. Green = OK
3. Red = Empty, Lot Expired
that is both Low Level and Lot Expired is displayed as Lot
Expired.
Expiration Displays the expiration date for the sample onboard wash
solution. The color-coded indicator changes colors as follows:

the lot expiration.


expiration.

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Stability Hours Displays the number of hours of onboard stability for the
sample onboard wash solution. The color-coded indicator
changes colors as follows:



onboard stability.
The sample onboard wash solution is stable for 24 hours.
Position The Acid Probe Wash area displays position 1, the location of
the sample onboard wash solution in the sample wash
solution area. The Detergent A area displays position 2, the
location of the sample onboard wash solution in the sample
wash solution area.
Liquid Waste area

NOTE: The Liquid Waste area is displayed only when the area is configured for Liquid Waste
Container.
Status bar Displays a graphical representation of the status and available

capacity. Statuses are indicated by the following colors:
1. Green = OK
2. Yellow = Near Capacity
3. Red = Full
The liquid waste status on each module is indicated as the

percent of capacity remaining.

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Function button
Supplies screen, Supply Details flyouts for Alkaline Wash, Acid Wash, and ICT Reference
element descriptions (c‑series)
In the Supply Details flyouts for Alkaline Wash, Acid Wash, and ICT Reference, the operator can
view the following information:
• The expiration date and lot number for the bulk solution bottle located in the bulk solution
storage area on the bulk solution door.
• The expiration date and lot number for the in-use bulk solution stored in the bulk solution
reservoir.
The operator can manually enter the expiration date and lot number when a new bulk solution
bottle is replaced.
Bottle Status Summary area

Under Bottle Status Summary, the following statuses are displayed:
• Bottle full: The bottle located on the bulk solution door is full.
• Bottle empty: The bottle located on the bulk solution door is empty.
• Confirm bottle replaced: The bottle located on the bulk solution door was replaced but has
not been confirmed in the system software.
• Transfer in process: The bulk solution from the bulk solution bottle located on the bulk
solution door is being transferred to the bulk solution reservoir.
Expiration Displays the expiration date of the bulk solution bottle located
on the bulk solution door. The color-coded indicator changes
colors as follows:

the lot expiration or the stability
expiration.

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Yellow The supply item exceeded the low alert

or is within 8 hours of exceeding the lot
expiration or the stability expiration.

Lot Displays the lot number of the bulk solution bottle located on
Expiration Displays a box that is used to select the lot expiration date
when a bulk solution is replaced.
Lot Number Displays a box that is used to enter the lot number when a
bulk solution is replaced.
Reservoir Summary area
Expiration Displays the expiration date of the in-use bulk solution stored
in the bulk solution reservoir. The color-coded indicator

expiration.
Yellow The supply item exceeded the low alert

or is within 8 hours of exceeding the lot

Lot Displays the lot number of the in-use bulk solution stored in
the bulk solution reservoir.
Function buttons



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Supplies screen, Supply Details flyout for ICT Module element descriptions (c‑series)
In the Supply Details flyout for the ICT module, the operator can manually enter an expiration
date and a lot number when the ICT module is replaced and can flush the new ICT module.
Elements
Expiration Displays a box that is used to select the expiration date when
the ICT module is replaced.
Serial Number Displays a box that is used to enter the serial number when
the ICT module is replaced.
Function buttons


Flush ICT Flushes the ICT module with ICT Reference Solution.
NOTE: The ICT module replacement cannot be completed
until the new ICT module is flushed.
Replace Displays a message requesting confirmation to replace the

ICT module and to inactivate all ICT assay calibrations.


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Supplies screen, Supply Details flyouts for Acid Probe Wash and Detergent A element
descriptions (c‑series)
In the Supply Details flyouts for Acid Probe Wash and Detergent A, the operator can manually
enter an expiration date and a lot number when a sample onboard wash solution located in the
sample wash solution holder is replaced.
Elements
when a sample onboard wash solution is replaced.
sample onboard wash solution is replaced.
Function buttons



Supplies screen, Supply Details flyout for Liquid Waste element descriptions (c‑series)
In the Supply Details flyout for Liquid Waste, the operator can update the status of the liquid
waste in the high-concentration waste bottle.
Element
Emptied Liquid Waste Displays a check box that is used to update the status of the
liquid waste in the high-concentration waste bottle.
Function buttons


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Supplies screen element descriptions (i‑series)
Elements
Module bar Used to select an individual module to view supply status

information.
Pre-Trigger area, Trigger area, Wash Buffer area

The following statuses may be displayed in the Pre-Trigger area, the Trigger area, and the
Wash Buffer area:
• Bottle empty: The bottle located in the bulk solution storage area is empty.
• Confirm bottle replaced: The bottle located in the bulk solution storage area was replaced
but has not been confirmed in the software.

colors:
1. Green = OK
3. Red = Empty, Lot Expired, Stability Expired
that is both Low Level and Stability Expired is displayed as
Stability Expired.
Total Remaining Estimated percent of bulk solution available in both the

reservoir and bulk solution storage area. The total remaining
volume includes the reservoir bottle and the bulk solution
bottle volumes minus the solution volume needed for tests

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that have been scheduled but not yet processed. The color-
coded indicator changes colors as follows:
Green The supply item percent remaining is

above the low alert setting.
Yellow The supply item percent remaining is at

or below the low alert setting.
Red The supply item percent remaining is

zero.
Replaced button Used to confirm bottle replacement when the bar code
scanner is not used. This action resets the onboard stability
time when the operator indicates that the item is replaced.
Currently in Use Displays information about the solution contained in the

reservoir.
Expiration Displays the expiration date for the bulk solution currently in

the lot expiration.


expiration.
Stability Days Displays the number of days that the bulk solution has been
onboard the system. The color-coded indicator changes
colors as follows:



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onboard stability.
The indicator is yellow when the supply item status has been
overridden.
RVs area

colors:
1. Green = OK
2. Yellow = Low Level
3. Red = Empty
Lot Displays the lot number for the RVs currently in use.
RV Waste area

colors:
1. Green = OK
2. Yellow = Near Capacity
3. Red = Full
The solid waste status on each module is indicated as

percent of capacity remaining and is displayed as a numeric
value between 0 and 100.
Function button

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Supplies screen, Supply Details flyouts for Pre-Trigger, Trigger, and Wash Buffer element
descriptions (i‑series)
In the Supply Details flyouts for Pre-Trigger, Trigger, and Wash Buffer, the operator can view the
• The expiration date and lot number for the bulk solution bottle located in the bulk solution
storage area on the bulk solution door.
• The expiration date and lot number for the in-use bulk solution stored in the bulk solution
reservoir.
The operator can manually enter the expiration date and lot number when a new bulk solution
bottle is replaced.
Bottle Status Summary area

Under Bottle Status Summary, the following statuses are displayed:
• Bottle full: The bottle located on the bulk solution door is full.
• Bottle empty: The bottle located on the bulk solution door is empty.
• Confirm bottle replaced: The bottle located on the bulk solution door was replaced but has
not been confirmed in the system software.
Expiration Displays the expiration date of the bulk solution bottle located
on the bulk solution door. The color-coded indicator changes
colors as follows:

expiration.

exceeding the lot expiration or the
stability expiration.

Lot Displays the lot number of the bulk solution bottle located on
when a bulk solution is replaced.

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bulk solution is replaced.
Reservoir Summary area
Expiration Displays the expiration date of the in-use bulk solution stored
in the bulk solution reservoir. The color-coded indicator

expiration.

exceeding the lot expiration or the
stability expiration.

Lot Displays the lot number of the in-use bulk solution stored in
the bulk solution reservoir.
Function buttons



Supplies screen, Supply Details flyout for RVs element descriptions (i‑series)
In the Supply Details flyout for RVs, the operator can update the status of the reaction vessels
(RVs) in the RV hopper.

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Elements
bag of RVs is added to the RV hopper.
RVs on Board Displays the total number of RVs in the RV hopper and
displays a box that is used to enter the estimated number of
RVs added to the RV hopper when a partial bag of RVs is
used.
Add 500 RVs Used to update the RV inventory when a full bag of RVs is
added to the RV hopper.
NOTE: The Add 500 RVs button is unavailable when the
number of RVs in the RV hopper is greater than 500.
Max. capacity Displays the maximum number of RVs that can be loaded into
the RV hopper. The maximum capacity of the RV hopper is
1000 RVs.
Function buttons



Supplies screen, Supply Details flyout for RV Waste element descriptions (i‑series)
In the Supply Details flyout for RV Waste, the operator can update the status of the reaction
vessels (RVs) in the RV waste container.
Element
Emptied RV Waste Displays a check box that is used to update the status of the
RV waste container.

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Function buttons



Solutions used in daily operations (c‑series)

The following tables describe the purpose, onboard stability, and placement information for
c‑series solutions used in daily operations.
Table 39: Bulk solutions (c‑series)
Solution Purpose Onboard stability Placement

ICT Reference Solution • ICT analysis 90 days Bulk solution door
• 5501 Daily
Maintenance
Alkaline Wash Wash the cuvettes 30 days Bulk solution door
Acid Wash Wash the cuvettes 30 days Bulk solution door
Table 40: Sample onboard wash solutions (c‑series)

Acid Probe Wash • Wash the sample 1 day Sample wash solution
probe area, position 1
• 5501 Daily
Maintenance
Detergent A • Wash the sample 1 day Sample wash solution
probe area, position 2
• 5501 Daily
Maintenance
Table 41: Onboard wash solutions (c‑series)

Acid Probe Wash • Wash the reagent 30 days Reagent carousel
probes

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• 5501 Daily
Maintenance
Detergent A • Wash the reagent 30 days Reagent carousel
probes
• 5501 Daily
Maintenance
Detergent B Wash the reagent probes 30 days Reagent carousel
c‑series Maintenance 5501 Daily Maintenance 14 days or 12 tests, Reagent carousel
Solutions whichever occurs first
Solutions used in daily operations (i‑series)

The following tables describe the purpose, onboard stability, and placement information for
i‑series solutions used in daily operations.
Table 42: Bulk solutions (i‑series)

Pre-Trigger Solution Assay processing 16 days Bulk solution door
(LN 06P1265)
Trigger Solution Assay processing 28 days Bulk solution door
(LN 06P1160)
Concentrated Wash Buffer Assay processing 30 days Bulk solution door
(LN 06P1368)
Table 43: Onboard solutions (i‑series)

Probe conditioning solution 2500 Daily Maintenance 52 days or 48 tests, Reagent carousel
whichever occurs first

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Verify the supply and waste inventory

Perform this procedure to verify the supply and waste inventory before sample processing is
initiated or when a status indicator is displayed.
NOTE: The status that is displayed reflects the inventory that remains after the system
processes samples that are scanned by the RSM bar code reader.
Orders can be created when inventory levels are insufficient. However, when sample processing
is initiated while the levels are insufficient, tests become exceptions and are not processed.
1. On the menu bar, tap Supplies.
2. On the Supplies screen, tap a Module button.
3. Verify the supply and waste inventory.
Initiate or resume sample processing, page 648
Replace bulk solutions and update the inventory

Perform this procedure to replace and update the bulk solution inventory when a bottle is empty,
has reached the onboard stability expiration date, or is expired.
NOTE: For bulk solutions that have an onboard stability claim, onboard stability tracking occurs
when the bottle is replaced and is updated. To achieve the maximum usage of the bulk solution,
do not replace the solution until the total percent of the remaining solution is below the low alert
setting.
NOTE: To replace a new lot number of ICT Reference Solution, the instrument status of the
c‑series processing module must be Stopped, Warming, or Idle and the bulk solution status must
be Empty. Perform quality control testing before assay processing.
CAUTION: Chemical Hazard. This activity or area exposes you to a chemical hazard.
1. Verify that a new bulk solution is within the expiration date on the bulk solution bottle label.
Do not use solutions that are expired.
NOTE: When bulk solution bottles are installed, the Alinity ci‑series tracks and maintains a
record of the bulk solution lot number, the expiration date and, when applicable, the onboard
stability.
NOTE: On the Supplies screen, the bar code scanner is activated. The operator must be on
the module-specific Supplies screen before scanning an inventory bar code.
4. Use the bar code scanner to scan the bar code on the new bulk solution bottle.

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Under Supply Details in the flyout, the system automatically updates the bulk solution with
the lot number and expiration date of the new bottle.
5. If the bar code cannot be scanned, manually enter the lot number and the expiration date,
and perform the following steps:
a. Tap Update for the new bulk solution.
b. Under Supply Details in the flyout, enter the expiration date and the lot number.
c. To save the information, tap Done.
6. Repeat step 4, page 579 or 5, page 580 for each bulk solution that is replaced.
7. Open the bulk solution door.
8. Press the bottle release button to disengage the empty bulk solution bottle from the bottle
holder.
NOTE: The color of the bulk solution cap matches the color of the bottle release button.
9. Remove and discard the empty bulk solution bottle according to the laboratory waste
disposal procedures of the facility.
10. Remove the protective cover from the cap of the new bulk solution bottle.

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11. Invert the new bulk solution bottle and place it in the bottle holder.
12. Push down the bottle until it locks.
13. Close the bulk solution door.
NOTE: When the bulk solution door is closed, the door sensor confirms that the bottle was
replaced.
To confirm manually that the bottle was replaced, tap Replaced on the Supplies screen.
Waste handling and disposal, page 826
Replace sample onboard wash solutions and update the inventory (c‑series)
Required instrument Idle

status
Required materials • 16 mm x 100 mm sample tubes
• Cartridge of Acid Probe Wash, LN 01R6070
• Cartridge of Detergent A, LN 08P9670
• Measuring device that can deliver up to 10 mL
Perform this procedure to replace the sample onboard wash solutions, Acid Probe Wash and
Detergent A, and to update the inventory when the sample tubes are empty or the wash solutions
are expired.
1. To replace Acid Probe Wash, use a measuring device to dispense from 1 mL through 10 mL
of the wash solution from either cartridge bottle into a 16 mm x 100 mm sample tube.
2. To replace Detergent A, use a measuring device to dispense from 1 mL through 10 mL of
the wash solution from either cartridge bottle into a 16 mm x 100 mm sample tube.
3. Lift the rear processing center cover.
4. Locate the sample wash solution holder.

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5. Remove each empty or expired tube of wash solution and place each new tube in the
appropriate position:
– Acid Probe Wash [1]
– Detergent A [2]
IMPORTANT: The operator has a responsibility to load the correct wash solution in the
correct position.
6. Discard the used sample tubes according to the laboratory waste disposal procedures of the
facility.
7. Close the rear processing center cover.
10. Use the bar code scanner to scan the bar code on the Acid Probe Wash cartridge.

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Under Supply Details in the flyout, the system automatically updates the sample onboard
wash solution with the lot number and expiration date of the cartridge.
To enter manually the lot number and the expiration date, perform the following steps:
a. Tap Update for the new sample onboard wash solution.
b. Under Supply Details in the flyout, enter the expiration date and the lot number.
c. To save the information, tap Done.
NOTE: After the new sample onboard wash solution is updated in the system software, the
onboard stability of the solution is 24 hours.
11. Repeat step 10, page 582 for the Detergent A cartridge.
12. Place a new replacement cap on each bottle in each cartridge to store the cartridges for
future use.
13. Store the cartridges in an upright position according to instructions in the product
documentation.
Empty the high-concentration waste bottle and update the inventory (c‑series)
Required instrument Offline, Stopped, or Idle

status
Required materials Absorbent towels
Perform this procedure to empty the high-concentration waste bottle when the bottle is full.
CAUTION: Lifting Hazard. This activity or area exposes you to a lifting hazard.
1. Disconnect the float switch cable from the waste bottle cap.
2. Place an absorbent towel next to the waste bottle to absorb any spills from the cap.
3. Unscrew the waste bottle from the cap. Ensure that the tubing attached to the cap is not
kinked.
4. Place the cap with the attached tubing on the absorbent towel.
5. Dispose of liquid waste according to the laboratory biohazard waste disposal procedures of
the facility.

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CAUTION: Do not move open waste containers that are filled with liquid. Close full
or partially full containers before attempting to move them. Keep the closures in
place while the containers are moved.
6. Screw the cap onto the waste bottle. Ensure that the tubing attached to the cap is not
kinked.
7. Reconnect the float switch cable.
10. Tap Update for the liquid waste.
11. Under Supply Details in the flyout, tap the Emptied Liquid Waste check box.
12. To save the information, tap Done.
Remove the RV waste and update the inventory (i‑series)
Required materials Biohazard bag
Perform this procedure to empty the RV waste container and to update the RV waste status.
1. Open the bulk solution door and the front electronics door.

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2. Pull out the RV waste storage tray.

3. Remove and discard the biohazard bag and its contents according to the laboratory
biohazard waste disposal procedures of the facility.
4. Install a new biohazard bag in the RV waste container.
NOTE: The biohazard bag must fit snugly and must be opened fully in the RV waste
container so that reaction vessels can drop freely into the container.
5. Slide the RV waste storage tray into the RV waste storage area until the RV waste chute is
fully open.
6. Close the bulk solution door and the front electronics door.
9. Tap Update for the RV waste.
10. Under Supply Details in the flyout, tap the Emptied RV Waste check box.

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Replenish reaction vessels (RVs) and update the inventory (i‑series)

Perform this procedure to replenish and update the reaction vessel (RV) inventory when the
inventory is low or is empty.
3. Tap Update for the RVs.
4. Use the bar code scanner to scan the bar code on the new RV bag (or manually enter the
lot number in the Lot Number box).
Under Supply Details in the flyout, the system automatically updates the RVs with the lot
number of the new RV bag.
NOTE: To ensure that the bar code is read, perform the following steps:
– Verify that RVs are present behind the bar code on the RV bag to provide a contrast for
the bar code.
– Place the RV bar code 10 cm to 13 cm (4 in. to 5 in.) from the bar code scanner.
– Center the bar code scanner beam on the bar code label.
5. If one or more full bags of RVs are added to the RV hopper, tap Add 500 RVs after each
bag is added.
If a partial bag of RVs is added to the RV hopper, enter the estimated number of RVs that
are added.
The maximum capacity of the RV hopper is 1000 RVs.
7. Open the RV hopper cover.

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8. To add a full bag of RVs, pour all contents of the bag into the RV hopper.
To add a partial bag of RVs, pour some contents of the bag into the RV hopper and
estimate the quantity of RVs that were added.
NOTE: Do not overfill the RV hopper.
9. Close the RV hopper cover.
Cal/QC Inventory screen

On the Cal/QC Inventory screen, the operator can view the following information:
• Inventory details for quality control vials that are run on the system
• Inventory details for calibrator vials that are used to calibrate assays

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Cal/QC Inventory screen element descriptions, page 588
Cal/QC Inventory screen, Search flyout element descriptions, page 589
Descriptions of vial statuses, page 590
Verify vial inventory data, page 591
page 641
Cal/QC Inventory screen element descriptions
All Vials tab, Calibrator tab, Control tab

Display status information for all calibrator and control vials that are scanned by the system.
Calibrator and control vial status information can be filtered by selecting the Calibrator tab or
the Control tab.
Elements
M/P Displays the module (M) number and position (P) number in
the reagent carousel for vial racks that are stored on the
system. Dashes are displayed for the module and position
when the vial rack is not located in the reagent carousel.
RSM/P Displays the reagent and sample manager (RSM) module

number and position (P) number where the rack that contains
the calibrator or control vial is located. The RSM and position
are blank when the vial rack is not located on the RSM.
Rack/P Displays the rack ID and position (P) of the calibrator or

control vial in the rack.
Name Displays the calibrator or control name, which can be one of

the following items:
• The calibrator assay or calibrator set name, CAL (only for
i‑series), and the calibrator level.
• The control name and, if configured, the control level
number and control level name for control orders.
Lot Displays the lot number of the calibrator or control.
SN Displays the serial number of the calibrator or control vial.

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Vial Status Displays the calibrator or control vial status (Empty, LLS Error,
Expired, Low Alert, Overridden, or OK).
Remaining Capacity Displays the percentage of volume that remains in the

calibrator or control vial. The percentage of remaining volume
is based on a maximum fill volume of 3 mL for the small vial
and 5.5 mL for the tall vial. Some calibrator products that are
filled in the tall vial may have the maximum fill volume defined
in the assay parameters, and the percent remaining is based
on this value. The remaining capacity is not displayed until
after the first aspiration.
Onboard Stability Displays the stability of open vials of calibrators or controls

that are stored on the system in the reagent carousel.
Onboard stability tracking occurs after the vial is scanned by
the RSM bar code reader and is scheduled to be loaded in
the reagent carousel. The onboard stability tracking continues
when the vial is unloaded from the system.
In Use Stability Displays the remaining time that the calibrator or control is
known to have been removed from refrigerated storage. In-
use stability tracking occurs after the vial is scanned by the
RSM bar code reader. For calibrators, in-use stability tracking
stops when the vial is unloaded from the RSM (for c‑series
and i‑series) or is returned to the reagent carousel (only for
c‑series). For controls, in-use stability tracking stops when the
vial is unloaded from the RSM or is returned to the reagent
carousel. Quality controls that have the in-use stability
configured as zero are not tracked.
Expiration Displays the expiration date of the calibrator or control.
Load Status Displays the status of vial racks that are loaded or unloaded
between the RSM and the reagent carousel.
Function button
Cal/QC Inventory screen, Search flyout element descriptions

The Search flyout of the Cal/QC Inventory screen provides calibrator or control information.

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Elements
Name Filters data by the name of the calibrator or control.
Lot Filters data by the lot number of the calibrator or control.
SN Filters data by the serial number of the calibrator or control

vial.
Function buttons



Descriptions of vial statuses

Vial status information is used to determine the status of each calibrator (Cal) vial and quality
control (QC) vial and to determine if any problems with onboard vials have occurred.
When all the vials in an onboard vial rack have a status of Empty, LLS Error, or Expired, the
onboard vial rack is unloaded automatically from the reagent carousel.
The following list provides descriptions of the vial statuses. When the Vial Status column header
is selected, the statuses are sorted in the following order:
Empty A Cal or QC vial is empty.
LLS Error One liquid level sense or pressure monitor error occurred
during aspiration of a Cal or QC vial.
Expired A Cal or QC vial is expired or has exceeded the stability time.
Low Alert The remaining volume of a Cal or QC vial is below the

configured volume for the low alert notification.

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Overridden The operator has overridden a Cal or QC vial that is expired

or has exceeded the stability time.
OK A Cal or QC vial is okay.
Verify vial inventory data

Perform this procedure to verify the vial inventory data for calibrator and control vials that were
previously scanned by the RSM bar code reader before performing sample processing.
NOTE: Calibrator and control vials that were previously stored on the system must be loaded into
the same onboard vial rack if the vials are returned to onboard storage.
The data on the Cal/QC Inventory screen does not reflect the usage of the calibrator and control
vials on a processing module that is controlled by a different system control module.
1. On the menu bar, tap System, and then tap Cal/QC Inventory.
NOTE: The Cal/QC Inventory command can be configured as an icon on the menu bar and
thereby is removed from the System menu.
2. On the All Vials tab of the Cal/QC Inventory screen, use the bar code scanner to scan the
bar code on the vial.
NOTE: The vial inventory data is filtered and the scanned vial data is displayed.
3. Verify the vial inventory data for the scanned vial.
4. Repeat steps 2, page 591 and 3, page 591 for each vial to be scanned.
NOTE: Vials that are scanned after the first vial are added to the list that is displayed on the
screen in the order in which they are scanned.
5. To display the inventory data for all vials, tap Clear Filter.

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Reagent and sample management Section 5
Reagent and sample management

Reagent and sample management includes procedures for the following activities:
• Manage reagent carousel inventory.
• Prepare, load, and unload samples.
• Initiate sample processing.
Load racks and cartridges into trays, page 592
Load trays on the reagent and sample manager (RSM), page 594
Load racks on the reagent and sample manager (RSM), page 595
Load bar-coded specimens for batch processing, page 597
Load cartridges on the reagent and sample manager (RSM), page 599
Load onboard vial racks or cartridges on a specific processing module, page 602
Load onboard solutions and sample diluents on the reagent and sample manager (RSM)
(c‑series), page 604
Assign a temporary priority position to load racks and cartridges, page 606
Unload trays from the reagent and sample manager (RSM), page 607
Reagent carousel inventory management, page 607
Load racks and cartridges into trays

Perform this procedure to load prepared racks and cartridges into trays.
IMPORTANT: When transporting or loading racks, avoid splashing the sample outside the
sample cups and tubes.
1. Position the rack or cartridge so that the rack handle or cartridge handle is located at the
front of the tray, which is indicated by an arrow.
2. Slide the rack or cartridge into the tray until the rack or cartridge stops.

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Section 5 Reagent and sample management
3. Confirm that the rack or cartridge is flush against the back of the tray.
Prepare reagent cartridges, page 622
Prepare onboard solutions (c‑series), page 625
Prepare and load calibrator and control vials into vial racks for immediate use, page 646
Prepare and load calibrator and control vials into vial racks for onboard storage, page 624

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Load trays on the reagent and sample manager (RSM)

Perform this procedure to load trays in routine positions or priority positions on the reagent and
sample manager (RSM). Empty trays may remain on the loading area to create five positions to
load racks or cartridges one at a time.
1. For routine loading on the RSM, confirm that the status indicators above the bay positions to
load are not illuminated, which indicates that the positions are available.
For priority loading on the RSM, confirm that the status indicators above the bay positions to
load are blue, which indicates that the positions are available.
2. Hold the tray handle, which is indicated with an arrow, and slide the tray into a bay on the
RSM until the tray stops.
If the tray contains racks or cartridges, green status indicators are illuminated.

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Assign a temporary priority position to load racks and cartridges, page 606
Load racks on the reagent and sample manager (RSM)

Required instrument • Processing module: Warming, Idle, Running, Processing,
status or Pausing
• Reagent and sample manager (RSM): Running
Perform this procedure to load prepared sample racks or vial racks on the RSM. Racks can be
loaded in routine positions or priority positions.

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2. Hold the rack handle, and slide the rack into a routine position or a priority position on the
RSM until the rack is flush against the back of the tray. Confirm that the green status
indicator illuminates.
If the position on the RSM does not contain a tray, load the rack into a tray and slide the
tray into the RSM.
NOTE: For calibrator and control vials that have an onboard stability claim, onboard stability
tracking occurs after the vial is scanned by the bar code reader.

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For calibrators that have an in-use stability claim, in-use stability tracking occurs after the vial is
scanned by the bar code reader. After the vial is unloaded from the RSM, the timer for in-use
stability tracking stops.
Load bar-coded specimens for batch processing

Perform this procedure to load bar-coded specimens for batch processing.
IMPORTANT: When loading specimens for batch processing, do not load calibrators or leave
empty spaces between samples. Empty spaces are identified as invalid samples and generate a
message code. The functionality for host query and laboratory automation system is unavailable
when a batch order is being processed.
Samples with explicit orders and controls can be processed within a batch order. The system
runs only the explicit orders associated with a sample and does not create batch orders for the
sample.
1. Locate the sample rack that contains the sample labeled with the starting SID that was
entered in the batch order.
Verify that the sample is loaded in position 1 of the rack.
2. Position the rack so that the rack handle is located at the front of the tray, which is
indicated by an arrow.
3. Slide the rack into the tray until the rack stops.

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4. Confirm that the rack is flush against the back of the tray.
5. Load additional racks from the left side to the right side of the tray until the tray is full or all
samples are loaded.
6. If more than one tray is needed, repeat steps 2, page 597 through 5, page 598 with
additional trays until all samples are loaded.
7. Ensure that the sample labeled with the ending SID is loaded at the end of all samples in
the batch.
8. Confirm that the status indicators above the bay positions to load are not illuminated, which
indicates that the positions are available.
9. Hold the tray handle, which is indicated with an arrow, and slide the tray into the bay that is
leftmost on the reagent and sample manager until the tray stops.
The green status indicators will illuminate.

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10. If more than one tray is needed, repeat steps 7, page 598 through 9, page 598 with
additional trays by using the next bay on the right side of the loaded bay until all samples
are loaded.
Load cartridges on the reagent and sample manager (RSM)

status or Pausing
Perform this procedure to load prepared cartridges on the RSM. The RSM automatically loads
cartridges in the reagent carousel. Cartridges can be loaded in routine positions or priority
positions. If one cartridge of a two-cartridge reagent set is loaded in a priority position, both
cartridges will be priority loaded.

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If a reagent cartridge is loaded, and a specific processing module is not specified, and more
than one module is eligible to accept the cartridge, the cartridge is loaded on the module with
the lowest usable, onboard total test count for the reagent.
If a diluent cartridge or an onboard solution cartridge is loaded, and a specific processing
module is not specified, and more than one module is eligible to accept the cartridge, the
cartridge is loaded on the module with the lowest usable, onboard total volume for the diluent or
onboard solution.
If a maintenance cartridge is loaded, and a specific processing module is not specified, and
more than one module is eligible to accept the cartridge, the cartridge is loaded on the lowest
numbered, eligible module.
NOTE: To ensure correct tracking status, do not move the cartridges to a processing module
that is controlled by a different system control module.
2. Hold the cartridge handle, and slide the cartridge into a routine position or a priority position
on the RSM until a green status indicator illuminates.
If the position on the RSM does not contain a tray, load the cartridge into a tray and slide
the tray into the RSM.
NOTE: Some assays require two reagent cartridges. These reagent cartridges are indicated
with 1/2 and 2/2 on them. Both reagent cartridges must be loaded, but they do not need to
be inserted into adjacent positions. After the reagent cartridges are loaded on the RSM and
the bar code reader scans the bar code label, the system software links the two reagent
cartridges as a set. If a two-cartridge reagent set is removed from the system, the reagent
set must be replaced as a set.

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NOTE: For products that have an onboard stability claim, onboard stability tracking occurs
after the cartridge is scanned by the bar code reader. After the cartridge is unloaded from
the reagent carousel and is removed from the RSM, the timer for onboard stability tracking
stops.
For information about product onboard stability, see the product documentation.
2500 Daily Maintenance (i‑series), page 868
Perform an initial user-defined assay run (c‑series), page 1603

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Load onboard vial racks or cartridges on a specific processing

module
status or Pausing
Perform this procedure to load onboard vial racks into the reagent carousel of a specific
processing module or to load prepared cartridges into the reagent carousel of a specific
processing module if more than one processing module of the same type is configured for a
system.
1. On the left side of the loading area of the specific processing module, press the priority
button.
When the priority button is pressed, the button illuminates.

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2. Confirm that the status indicators above the bay positions to load are not illuminated, which
indicates that the positions are available.
3. Hold the cartridge handle, and slide the cartridge into any position on the loading area of the
specific processing module until a green status indicator illuminates.
When a cartridge is inserted into a position, the system designates the cartridge to be
loaded in the reagent carousel of the specific processing module.
NOTE: After the priority button is pressed, the cartridge must be inserted into a position
within 10 seconds. To deactivate the RSM priority button before the time-out expires, press
the priority button again.
Some assays require two reagent cartridges. These reagent cartridges are indicated with
1/2 and 2/2 on them. Both reagent cartridges must be loaded, but they do not need to be
inserted into adjacent positions. After the reagent cartridges are loaded on the RSM and the
bar code reader scans the bar code label, the system software links the two reagent
cartridges as a set. If a two-cartridge reagent set is removed from the system, the reagent
set must be replaced as a set.

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– Tap Yes to load the cartridge on the selected processing module.
– Tap No to priority load the cartridge on a processing module by using the system
scheduler.
NOTE: If a reagent cartridge is loaded, and a specific processing module is not specified,
and more than one module is eligible to accept the cartridge, the cartridge is loaded on the
module with the lowest usable, onboard total test count for the reagent.
If a diluent cartridge or an onboard solution cartridge is loaded, and a specific processing
module is not specified, and more than one module is eligible to accept the cartridge, the
cartridge is loaded on the module with the lowest usable, onboard total volume for the
diluent or onboard solution.
If a maintenance cartridge is loaded, and a specific processing module is not specified, and
more than one module is eligible to accept the cartridge, the cartridge is loaded on the
lowest numbered, eligible module.
NOTE: For products that have an onboard stability claim, onboard stability tracking occurs
after the cartridge is scanned by the bar code reader. After the cartridge is unloaded from
the reagent carousel and is removed from the RSM, the timer for onboard stability tracking
stops.
Load onboard solutions and sample diluents on the reagent and

sample manager (RSM) (c‑series)
Required instrument • Processing module: Idle, Running, Processing, or Pausing
status
Perform this procedure to load prepared onboard solution and sample diluent cartridges on the
RSM. The RSM automatically loads cartridges in the reagent carousel. Cartridges can be loaded
in routine positions or priority positions.

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2. Hold the cartridge handle, and slide the cartridge into a routine position or a priority position
on the RSM until a green status indicator illuminates.

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NOTE: For onboard solutions that have an onboard stability claim, onboard stability tracking
occurs after the cartridge is scanned by the bar code reader. After the cartridge is unloaded
from the reagent carousel and is removed from the RSM, the timer for onboard stability
tracking stops.
Assign a temporary priority position to load racks and cartridges

Perform this procedure to assign temporarily a reagent and sample manager (RSM) position as
a priority position if no priority positions are configured or if additional priority positions are
required. Priority positions are designated with a blue status indicator above the bay position.
1. On the left side of the loading area of a processing module, press the priority button [1].
When the priority button is pressed, the button illuminates.

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2. Insert a rack, cartridge, or tray into any position on the loading area of the specific
processing module.
If a rack is inserted into a position, the system designates the position as a priority position.
If a tray is inserted into a position, all positions of the tray are designated as priority
positions. When the rack is removed, the blue status indicator for the priority position is not
illuminated.
NOTE: After the priority button is pressed, the rack, cartridge, or tray must be inserted into a
position within 10 seconds. To deactivate the RSM priority button before the time-out
expires, press the priority button again.
Unload trays from the reagent and sample manager (RSM)

Prerequisite Confirm that one of the following position indicators is
illuminated on the reagent and sample manager (RSM):
• Blinking green
• Steady green
• Alternating green and amber
Perform this procedure to unload trays from the RSM.

• Grasp the tray handle, which is indicated with an arrow, and slide the tray out of the RSM.
Reagent carousel inventory management

Reagent carousel inventory management includes procedures to prepare and unload reagent
carousel inventory items. Use the Reagents screen to view and manage in-use inventory.
Before performing sample processing, verify that onboard reagent inventory is adequate.

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Reagents screen
On the Reagents screen, the operator can view the following information for cartridges and
racks that are loaded in the reagent carousel:
• The Current tab displays:
– A list of cartridges and racks that are currently loaded on the system for all modules.
– A graphical representation of the reagent carousel for individual modules that indicates
the position and status of the cartridges and racks.
• The Historical tab displays a list of cartridges and racks that are currently loaded on the
system and were previously loaded on the system.

• Search for a specific cartridge or rack based on specified search criteria.
• Access reagent cartridge details.
• Unload a cartridge.
• Print a reagent report.
Reagent carousel inventory management, page 607
Reagents screen, Current tab element descriptions, page 609
Reagents screen, Historical tab element descriptions, page 612
Reagents screen, Search flyout element descriptions, page 614
Reagent Cartridge Details screen, page 615
Descriptions of cartridge statuses, page 617
Descriptions of load statuses, page 619
Descriptions of assay insert statuses, page 621
Verify the reagent carousel inventory, page 622
Unload racks and cartridges from a reagent carousel to the RSM, page 631
Cancel a rack unload or a cartridge unload, page 632
Unload reagents from the reagent and sample manager (RSM), page 633

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Disable a reagent cartridge, page 634

Enable a reagent cartridge, page 634
View or print assay inserts, page 635
Descriptions of vial statuses, page 590
View or print Abbott Mail documentation, page 553
Reagents screen, Current tab element descriptions

The Current tab displays the reagent carousel inventory information for items loaded in the
reagent carousel or on the reagent and sample manager (RSM).
Elements
Module bar - All button
Module bar Used to select all modules or an individual module to view

reagent status information.
All button Displays the reagent status information in a table format for
all modules.
the reagent carousel where the reagent carousel inventory
item is loaded. If cartridges are stuck on the reagent
positioner because of a load error or an unload error, a
module number and an asterisk for the position number are
displayed.
RSM/P Displays the RSM module number and position (P) number on
the loading area where the reagent carousel inventory item is
loaded or unloaded.
Name Displays the name of the reagent carousel inventory item.
Cartridge Status Displays the status of the reagent carousel inventory item.
For statuses other than OK, Mixing (only for i‑series), Low
Alert, Disabled, and Overridden, the text in the list associated
with the item is displayed in red.
Remaining Displays the estimated amount that remains in the reagent

carousel inventory item. Information is not displayed for vial
racks.

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Cal Status Displays the calibration status of the assay that uses the
reagent cartridge. Information is displayed only for reagent
cartridges.
Lot Displays the lot number of the reagent carousel inventory

item. Information is not displayed for vial racks.
SN Displays the serial number of the reagent carousel inventory

Expiration Displays the expiration date of the reagent carousel inventory

item. If the expiration date is overridden, a cartridge status of
Overridden is displayed. Information is not displayed for vial
racks.
Load Status Displays the load or unload status of the reagent carousel
inventory item.
Onboard Stability Displays the number of onboard stability days that remain for
reagent carousel inventory items that have an onboard
stability claim. If the remaining time is less than 24 hours, < 1
is displayed. Information is not displayed for vial racks.
Module bar - Module button

reagent status information.
Module button Displays the reagent carousel graphic for an individual

module. In addition, reagent status information for the
individual module is displayed in the Reagent Carousel List
area.
An amber badge is displayed on the Module button when a
low alert status is triggered for one or more items in the
reagent carousel or when an item in the reagent carousel or
on the RSM is within 1 hour of the lot or onboard stability
expiration.
A red badge is displayed on the Module button when a
reagent carousel inventory item that has a load status error is
present or when a cartridge or rack that has a status other
than OK, Mixing (only for i‑series), Low Alert, Overridden, or
Disabled is displayed on the Current tab.
Reagent carousel Displays a graphical representation of the reagent carousel

graphic that displays the reagent carousel positions.

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The status of reagents and racks in the reagent carousel

positions is indicated by the following colors:
White No cartridge is loaded in the position.
Green A cartridge that has a status of OK or

Mixing (only for i‑series) is loaded in
the position.
Yellow A cartridge that has a status of Low

Alert, Overridden, or Disabled is loaded
in the position. This status also includes
reagents that have a lot or onboard
stability expiration within 1 hour.
Red A cartridge has an error condition

(such as LLS Error or Load Error) or a
status of Expired, Empty, No Assay,
Undefined, Incomplete, or BC Fail. The
text in the list associated with the item
is displayed in red.
Purple An onboard vial rack is loaded in the

position.
P Displays the reagent carousel position numbers.
Remaining Displays the estimated number of tests that remain in the

reagent cartridge. Information is not displayed for vial racks.
reagent cartridge. Information is not displayed for vial racks.
Load Status Displays the load or unload status of the reagent carousel
inventory item.
Scheduled Tests Displays the number of scheduled tests for the reagent
carousel inventory item.

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Ready to Unload Displays the time that the reagent carousel inventory item is
ready to unload.
Function buttons
between Select All and Deselect All. This function button is
displayed only when the All button is selected.
Details Navigates to the Details screen for the selected items on the
current screen.
Unload Unloads the selected reagent carousel inventory item.
Cancel Unload Cancels the unloading of the selected reagent carousel

inventory item.
Reagents screen, Historical tab element descriptions

The Historical tab displays the reagent carousel inventory information for reagents that are
currently loaded on the system or for reagents that were previously loaded on the system and
removed.
Elements
the reagent carousel where the reagent carousel inventory
item is loaded. If cartridges are stuck on the reagent
positioner because of a load error or an unload error, a
module number and an asterisk for the position number are
displayed.

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number and position (P) number on the loading area where
the reagent carousel inventory item is loaded or unloaded.

reagent carousel inventory item. Information is not displayed
for vial racks.
reagent cartridge. Information is displayed only for reagent
cartridges.
Lot Displays the lot number of the reagent carousel inventory

SN Displays the serial number of the reagent carousel inventory

Expiration Displays the expiration date of the reagent carousel inventory

Overridden is displayed. Information is not displayed for vial
racks.
Onboard Stability Displays the number of onboard stability days that remain for
is displayed. Information is not displayed for vial racks.
Unload Time Displays the time that the reagent carousel inventory item was
unloaded.
Function buttons

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current screen.
Reagents screen, Search flyout element descriptions

The Search flyout of the Reagents screen can be used to filter the Reagents screen to display
specific reagent carousel inventory items.
Elements
Module Used to search by the module.
Position Used to search by the reagent carousel position.

Reagent Lot Used to search by the lot number of the reagent carousel
inventory item.
Name Used to search by the name of the reagent carousel inventory
item.
Reagent SN Used to search by the serial number of the reagent carousel

inventory item.
Calibration Status Used to search by the calibration status.

Cartridge Status Used to search by the cartridge status.
Function buttons




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Descriptions of calibration statuses, page 804
Reagent Cartridge Details screen

On the Reagent Cartridge Details screen, the operator can view the following information:
• Cartridge details for reagents, onboard solutions, diluents, and maintenance solutions
• Calibrator and control vial information
• Assay details
• Assay insert details

• Disable a reagent cartridge.
• Enable a reagent cartridge.
• View or print an assay insert.
Reagent Cartridge Details screen element descriptions, page 615
Reagent Cartridge Details screen element descriptions

The Reagent Cartridge Details screen displays the details of the selected reagent cartridge.
Reagent Cartridge Information area

Displays details of the selected reagent cartridge.
Status Displays the current status of the reagent cartridge.
Lot Number Displays the lot number of the reagent.
Expiration Displays the expiration date of the reagent carousel item. If

the expiration date is overridden, Overridden is displayed.
Expiration Status Displays the expiration status of the reagent cartridge:

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• OK: The expiration has not been exceeded.

• Expired: The expiration has been exceeded.

reagent cartridge.
Onboard Stability Displays the number of onboard stability hours that remain for
(Hours) the reagent cartridge.
Stability Status Displays the status of the stability of the reagent cartridge:
• OK: The stability has not been exceeded.
• Expired: The stability has been exceeded.
NOTE: Stability status is not shown for sample diluents.
Assay Details area

Displays the specific assay details.
Module Displays the number of the module used to process the test.
Assay Number Displays the assay number.
Assay Version Displays the assay version.
reagent cartridge.
Cartridge Details area

Displays the specific reagent cartridge details.
ID Displays the cartridge ID number.
SN Displays the serial number of the reagent cartridge.
Position Displays the position on the reagent carousel in which the

reagent cartridge is placed for processing. If cartridges are
stuck on the reagent positioner because of a load error or an
unload error, an asterisk is displayed for the position.

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number and position number where the reagent cartridge is
located.
Load Status Displays the status of reagents that are loaded or unloaded
between the RSM and the reagent carousel.
Assay Insert Details area

Used to view a portable document format (PDF) version of an assay insert if the status of the
assay insert details is New or Current.
Date and Time Displays the date and time that an assay insert download was
requested.
Status Displays the download status when an assay insert is

requested.
Function buttons

Disable Disables the selected reagent. This function button switches

between Disable and Enable.
Previous Displays the previous item when multiple items are selected.
Next Displays the next item when multiple items are selected.
Descriptions of cartridge statuses

Cartridge status information is used to determine the status of each reagent carousel inventory
item and to determine if any problems with onboard inventory items have occurred. Reagent
carousel inventory can include the following items:
• Reagents

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• Calibrators and controls
• Maintenance solutions
• Diluents
When a reagent carousel inventory item has a status of Empty, LLS Error, or Expired, the system
initiates a cartridge unload request.
The following list provides descriptions of the cartridge statuses. When the Cartridge Status
column header is selected, the statuses are sorted in the following order:
BC Fail The bar code on a reagent carousel inventory item is not

readable.
NOTE: This status is also displayed when the reagent
carousel cover is removed. When the instrument status of the
reagent and sample manager (RSM) is Running, reagent
carousel items are removed from the reagent carousel, are
scanned, and are reloaded.
Undefined The reagent configuration for a 1D reagent bar code is not

defined.
Load Error A hardware error occurred when a reagent cartridge was

loaded and prevented the loading of the cartridge in the
reagent carousel.
Incomplete A hardware error occurred when a two-cartridge reagent set

was loaded or unloaded, which caused the reagent cartridges
to be separated.
NOTE: One of the following conditions can cause this status
to display:
• One reagent cartridge is located on the RSM and the
other cartridge is located in the reagent carousel.
• One reagent cartridge is located on the RSM or the
reagent carousel and the other cartridge is no longer
stored on the system.
No Assay A reagent is not used by any assay file that is installed on the
system.
Empty A reagent carousel inventory item is empty.

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LLS Error Three consecutive liquid level sense or pressure monitor

errors occurred during aspiration of a reagent carousel
inventory item.
Expired A reagent inventory item is expired or has exceeded the

onboard stability time.
Disabled The operator or the system has disabled a reagent cartridge

to prevent the processing of patient samples.
Low Alert The remaining volume of a reagent carousel inventory item is

below the configured number of tests for the low alert
notification.
Overridden The operator has overridden a reagent carousel inventory

item that is expired or has exceeded the onboard stability
time.
Mixing The reagent is being mixed to disperse the microparticles.

NOTE: This status is not displayed for c‑series reagents.
OK A reagent carousel inventory item is okay.
Reagent Status Report element descriptions, page 1681
Descriptions of load statuses

Load status information is used to determine the status of the loading and unloading of
cartridges and racks and to determine if loading problems or unloading problems have occurred.
The following list provides descriptions of the load statuses. The statuses are described in the
Unload Error A cartridge or rack cannot be unloaded because one of the

following situations occurred:
• A hardware error occurs when the cartridge or rack is
unloaded.
• A hardware condition prevents the unloading of cartridges
or racks.

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• The instrument status of the processing module

transitions to Stopped while the cartridge or rack is being
unloaded.
• The instrument status of the reagent and sample
manager (RSM) transitions to Stopped or Idle while the
cartridge or rack is being unloaded.
Load Error A hardware error occurred when a cartridge or rack was

loaded, or a hardware condition prevents the loading of
cartridges or racks.
Scheduled Unload A cartridge or rack needs to be unloaded from the reagent

carousel, but the cartridge or rack cannot be unloaded
immediately because one of the following situations occurred:
• Tests are in process for the cartridge or rack.
• No positions are available on the RSM for the cartridge or
rack.
• The system is loading or unloading another cartridge or
rack.
Scheduled Load A cartridge or rack needs to be loaded in the reagent

carousel, but the cartridge or rack cannot be loaded
immediately because one of the following situations occurred:
• No positions are available in the reagent carousel for the
cartridge or rack.
• The system is loading another cartridge or rack.
Partially Unloaded The first cartridge of a two-cartridge reagent set has been
unloaded into the RSM, but the second cartridge cannot be
unloaded into the RSM because no positions are available.
Scanning The bar code reader has scanned the first cartridge of a two-
cartridge reagent set and is waiting to scan the second
cartridge.
Unloading A cartridge or rack is being unloaded from the reagent

carousel. For a two-cartridge reagent set, the load status
remains as Unloading until both cartridges have been
unloaded.
Loading A cartridge or rack is being loaded in the reagent carousel.

For a two-cartridge reagent set, the load status remains as
Loading until both cartridges have been loaded.

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<Blank> A status is not displayed for any of the following conditions:

• A cartridge or rack is loaded successfully in the reagent
carousel.
• A cartridge or rack is unloaded successfully into the
RSM.
• A cartridge or rack is loaded on the RSM but is not
scanned by the bar code reader.
Processing An onboard vial rack has been removed from the reagent
carousel for control processing or calibration processing.
Descriptions of assay insert statuses

Assay insert status information is used to determine if an assay insert is available to download, is
new, is current, or is disabled. The following list provides descriptions of the assay insert
statuses:
Requested An automatic request to download an assay insert has been

sent. The system software is waiting for a response from
AbbottLink.
New A new assay insert has been downloaded to the system

software and has been assigned to a reagent. The system
administrator has not reviewed and has not accepted the
assay insert in Abbott Mail.
Current The system administrator has reviewed and has accepted the
assay insert in Abbott Mail.
Unavailable An assay insert was not provided by AbbottLink, or the assay

insert is missing or is corrupted.
Disabled The system is not configured for Abbott Mail to send
automatic requests for assay inserts.
View or print assay inserts, page 635

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Verify the reagent carousel inventory

Perform this procedure to verify the reagent carousel inventory before sample processing is
initiated or when a status indicator is displayed. Reagent carousel inventory may include the
following items:
• Reagents
• Onboard solutions and diluents
• Maintenance cartridges
NOTE: The status that is displayed reflects the inventory that remains after the system
processes samples that are scanned by the RSM bar code reader.
Orders can be created when inventory levels are insufficient. However, when sample processing
is initiated while the levels are insufficient, tests become exceptions and are not processed.
1. On the menu bar, tap Reagents.
The Current tab of the Reagents screen displays the reagent carousel inventory for all
modules.
2. To display the reagent carousel inventory for one module, tap a Module button.
3. Verify the reagent carousel inventory.
Prepare reagent cartridges
Prerequisite For instructions for reagent handling and use, see the assay
documentation.
Perform this procedure to prepare reagent cartridges to load on the reagent and sample
manager (RSM).
IMPORTANT: For i‑series reagent cartridges that have an integrated septum, during assay
processing, the reagent pipettor pierces the reagent cartridge septum. After the septum is
pierced, do not invert the cartridge since this action causes reagent leakage and may
compromise test results. Store pierced cartridges in an upright position.

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1. Verify that the reagent cartridges are within the expiration date on the cartridge label. Do not
use cartridges that are expired.
NOTE: When a reagent cartridge is scanned by the RSM bar code reader, the
Alinity ci‑series tracks and maintains a record of the cartridge reagent lot number and
expiration date.
2. Verify that the reagent bottles have not leaked.
3. Turn the cap counterclockwise on each reagent bottle until the cap stops.
4. Align the tabs on the cap with the grooves in the reagent cartridge and pull the cap to
remove it.
NOTE: A reagent bottle that has a yellow cap requires special preparation. For specific
instructions for reagent handling, see the assay documentation.

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Prepare and load calibrator and control vials into vial racks for onboard storage
Prerequisite For instructions for calibrator or control handling and use, see
Required instrument Reagent and sample manager (RSM): Running

status
Perform this procedure to prepare and load calibrator or control vials for storage on the
NOTE: To ensure correct tracking status, do not move the vials to a processing module that is
controlled by a different system control module.
Onboard stability tracking occurs after the vial is scanned by the RSM bar code reader. In-use
stability tracking occurs when the calibrator is not in refrigerated storage while on the system.
If the calibrators or controls meet the criteria for automated orders when the calibrators or
controls are scanned by the RSM bar code reader, and the instrument status of the processing
module is Running or Processing, the orders are completed before the onboard vial rack is
loaded in the reagent carousel.
NOTE: Any c‑series assays that use a blank calibrator set are not eligible for onboard storage.
1. Verify that the calibrators or controls are within the expiration dates on the vial labels. Do
not use calibrators or controls that are expired.
NOTE: When a calibrator or control vial is scanned by the RSM bar code reader, the
Alinity ci‑series tracks and maintains a record of the calibrator lot number and expiration
date or the control lot number and expiration date.
2. Open each vial and discard the caps.
3. Inspect each vial for bubbles. Remove bubbles with a clean applicator stick before
performing sample processing. Use a new applicator stick for each vial to prevent cross
contamination.
4. Place each vial in the onboard vial rack with standoffs so that the vial bar code is visible in
the rack window and the bar code fills the width of the window.
5. Load the onboard vial rack on the RSM.
NOTE: After a vial is scanned by the RSM bar code reader, the vial is assigned to the
onboard vial rack and cannot be moved.

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Prepare onboard solutions (c‑series)
Prerequisite For instructions for onboard solution handling and use, see
the product documentation.
Perform this procedure to prepare cartridges of c‑series onboard solutions to load on the
reagent and sample manager (RSM).

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1. Verify that the onboard solution cartridges are within the expiration date on the cartridge
label. Do not use cartridges that are expired.
NOTE: When a cartridge is scanned by the RSM bar code reader, the Alinity ci‑series tracks
and maintains a record of the cartridge lot number and expiration date.
2. Verify that the onboard solution bottles have not leaked.
3. Turn the cap counterclockwise on each onboard solution bottle until the cap stops.
4. Align the tabs on the cap with the grooves in the cartridge and pull the cap to remove it.

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Prepare sample diluents and user-defined reagents (c‑series)

Required materials • c‑series Reagent Cartridge, Black (Large), LN 04S1720
or LN 04S1750; or c‑series Reagent Cartridge, Clear
(Large), LN 04S1740
• Measuring device that can deliver volumes from 46 mL
through 74 mL
• One-dimensional (1D) reagent bar code label that
corresponds to the diluent or reagent to be filled
Perform this procedure to fill and label reagent cartridges with the following items to load on the
reagent and sample manager (RSM):
• Saline for use as a diluent
• Saline for use with the Sample Interference Indices Saline Protocol
• User-defined diluents
• User-defined reagents
NOTE: The c‑series Reagent Cartridge, Black (Large), must be used for light-sensitive user-
defined diluents and user-defined reagents.
1. Verify that the saline, the diluent, and the reagents are within the expiration dates if dates
are provided. Do not use solutions that are expired.
2. Affix the 1D reagent bar code label to an R1 reagent bottle according to the following
guidelines. The R1 bottle is the larger bottle and is positioned leftmost in the cartridge when
the cartridge handle faces to the right side of the cartridge:
– Vertically orient the printed bars of the label within a vertical angle limit of ±5 degrees.
– Align the top edge of the label with the cartridge transport tab at the left edge of the R1
bottle.

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Figure 147: Correct placement of the 1D reagent bar code label on an empty reagent
cartridge
3. Determine whether the R1 bottle or the R1 and R2 bottles need to be filled:

– Saline diluent: R1 bottle
– Saline for use with the Sample Interference Indices Saline Protocol: R1 bottle
– User-defined diluent: R1 bottle
– User-defined reagent: R1 bottle or R1 and R2 bottles, based on the application
4. Turn the cap counterclockwise on each reagent bottle until the cap stops.
5. Align the tabs on the cap with the grooves in the cartridge and pull the cap to remove it.
NOTE: If only the R1 bottle needs to be filled, both reagent cartridge caps must be removed
to load the cartridge on the RSM.
6. Pour the saline, the other diluent, or the user-defined reagent into the measuring device.
NOTE: Between measurements of different solutions, use a separate measuring device,
dispose of the device, or thoroughly clean the device. Fill each reagent bottle according to
the maximum fill volumes for the cartridge list number used.
IMPORTANT: Since LN 04S1720 and LN 04S1750 are visually identical, if the cartridge list
number cannot be determined, use the fill volumes for LN 04S1720.
For LN 04S1720:
– R1 bottle, saline diluent: 74 mL
– R1 bottle, saline for use with the Sample Interference Indices Saline Protocol: 74 mL
– R1 bottle, user-defined diluent: 50 mL

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For LN 04S1740 or LN 04S1750:

– R1 bottle: 74 mL or to the maximum fill line (MAX)
– R2 bottle: 46 mL or to the maximum fill line (MAX)
For all list numbers, the dead volume of the R1 bottle is 3 mL and the dead volume of the
R2 bottle is 2.6 mL.
IMPORTANT: Do not exceed the maximum fill volumes for the reagent bottles to prevent
damage to the reagent carousel.
Figure 148: Prepare sample diluents and user-defined reagents
Reagent cartridge with empty bottles (c‑series), page 158

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Print a 1D reagent bar code report (c‑series)
Required materials Use one of the following Avery labels:

• 5520
• L4773
• L7060
Perform this procedure to print a one-dimensional (1D) reagent bar code report. The report
provides reagent cartridge labels to use with the following solutions:
• Saline for use as a diluent
• Saline for use with the Sample Interference Indices Saline Protocol
• User-defined diluents
• User-defined reagents
NOTE: The 1D reagent bar code report can be printed only for one diluent or one reagent at a
time. Additional reports can be generated after one report is completed.
3. On the Reagents and Supplies screen, tap the name of the diluent or reagent to print the
report:
– To print a label report for saline or another diluent, tap the diluent name under Diluent
Low Alert on the Reagents/Diluents tab.
– To print a label report for saline for the sample interference indices or a user-defined
reagent, tap the reagent name on the c-series Reagents tab.
4. Tap Print 1D Bar Code.
5. In the Print 1D Bar Code flyout, choose a printer or tap Print to File in the Print Location
drop-down list.
6. In the Label Options area, enter the following information:
– Lot
– Expiration
NOTE: The 1D reagent bar code format encodes expiration dates by the week. If the
entered expiration date does not correspond to the end of a seven-day week, the
expiration date for the printed bar code is the end of the previous week.
– Starting Serial Number

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– Number of Labels
NOTE: When the entry for the starting serial number is added to the number of labels to
print, the entry must not exceed 9999.
7. In the Report Selection list, tap one of the following options that correspond to the label
type:
– 1D Bar Code Report - 5520
– 1D Bar Code Report - L4773
– 1D Bar Code Report - L7060
8. Ensure that the printer contains a sufficient amount of label stock.
9. Tap Print.
d. Tap OK.
1D reagent bar code label placement (c‑series), page 468
Unload racks and cartridges from a reagent carousel to the RSM

status or Pausing
• Reagent and sample manager (RSM): Running or
Pausing
Perform this procedure to unload an item from a reagent carousel to the RSM. This procedure
provides space for a different item in the reagent carousel. Reagent carousel inventory may
include the following items:

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• Reagents
• Onboard solutions and diluents
• Maintenance items
The Alinity ci‑series automatically unloads items that have a cartridge status of Empty, Expired,
or LLS Error.
modules.
3. Confirm that the carousel item to unload is not required for tests that are in process.
If an item is unloaded, all scheduled tests that require the item become exceptions.
NOTE: View the Scheduled Tests column to identify whether a reagent has any scheduled
tests.
4. Tap the item to unload.
5. Tap Unload.
The item is unloaded to an available position on the RSM that is nearest to the system
control module.
NOTE: Multiple items can be selected and unloaded from the reagent carousel inventory
that is displayed for all modules on the Current tab. Only one item can be selected and
unloaded from the reagent carousel inventory that is displayed for the selected module.
Unload reagents from the reagent and sample manager (RSM), page 633
Cancel a rack unload or a cartridge unload
Prerequisite The load status of the rack or cartridge must be Scheduled

Unload.
Perform this procedure to cancel an unload request that was initiated by an operator and to
leave an item in the reagent carousel.
NOTE: If the system initiates an unload request because the carousel item has a cartridge status
of Expired, Empty, or LLS Error, the operator cannot cancel the unload request.
modules.

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3. Confirm that the carousel item has a load status of Scheduled Unload.
4. Tap the carousel item.
5. Tap Cancel Unload.
Unload reagents from the reagent and sample manager (RSM)
Prerequisite Confirm that one of the following status indicators is

• Blinking green
• Steady green
Perform this procedure to unload reagents from the RSM when the reagents are not needed on
the system.
1. Slide the reagent cartridge, or the tray that contains the cartridge, out of the RSM.
NOTE: Onboard stability tracking occurs after the reagent cartridge is scanned by the bar
code reader and is being loaded in the reagent carousel. After the reagent cartridge is
unloaded from the reagent carousel and is removed from the RSM, the timer for onboard
stability tracking stops.
For information about reagent onboard stability, see the assay documentation.
2. Place a new replacement cap on each reagent bottle in the reagent cartridge to store the
cartridge for future use.
Empty reagent cartridges can be discarded without replacement caps.
3. Store reagent cartridges in an upright position in refrigerated storage according to
instructions in the assay documentation.
Two reagent cartridges that are linked together by the system software must be stored
together as a set.
IMPORTANT: After an immunoassay reagent cartridge septum is pierced, do not invert the
reagent cartridge since this action causes reagent leakage and may compromise test
results.

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Unload racks and cartridges from a reagent carousel to the RSM, page 631
Disable a reagent cartridge

Perform this procedure to disable a reagent cartridge manually. A reagent cartridge is disabled
to prevent the processing of specimens by the system but to permit the manual ordering of
quality controls and calibrations to resolve performance issues with the cartridge. After the
issues are resolved, enable the cartridge so that the system can process the specimens.
modules.
3. Under Reagent Carousel List, tap a reagent cartridge to disable.
4. Tap Details.
5. On the Reagent Cartridge Details screen, tap Disable.
7. To return to the Reagents screen, tap Done.
IMPORTANT: To order a calibration or control for a disabled reagent cartridge, the cartridge
must be selected in the Assay Options flyout. If only one reagent cartridge is loaded on the
system, the disabled reagent cartridge is selected automatically.
Processing module corrective action procedures, page 1449
Enable a reagent cartridge

Perform this procedure to enable a reagent cartridge manually. A reagent cartridge is disabled to
prevent the processing of specimens by the system but to permit the manual ordering of quality
controls and calibrations to resolve performance issues with the cartridge. After the issues are
resolved, enable the cartridge so that the system can process the specimens.
modules.
3. Under Reagent Carousel List, tap a reagent cartridge to enable.
4. Tap Details.

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5. On the Reagent Cartridge Details screen, tap Enable.

7. To return to the Reagents screen, tap Done.
View or print assay inserts
Assay insert status New or Current
Perform this procedure to view or print assay inserts from the Reagent Cartridge Details screen.
modules.
3. Under Reagent Carousel List, tap a reagent cartridge.
4. Tap Details.
5. On the Reagent Cartridge Details screen, tap Print.
6. Under Report Selection in the Print flyout, tap Assay Insert.
To return to the Reagents screen, tap Done.
Descriptions of assay insert statuses, page 621

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Sample management
Sample management includes procedures used to prepare samples, to initiate processing, and
to unload samples. For more information about specimen collection, preparation, and storage,
see requirements for handling the specimens and see the assay documentation.
Before samples are loaded on the Alinity ci‑series, the operator must be familiar with sample and
sample bar code label requirements.
Sample processing, page 636
Suspend and access a sample that has tests in process, page 649
Unload samples from the reagent and sample manager (RSM), page 650
Unload vials from the reagent and sample manager (RSM), page 650
Sample processing
The progression of samples through the Alinity ci‑series differs based on the system
configuration and the available reagent inventory.
Various hardware components are used to process assays. Not all assay types use every
component on the system. The system continues to process assays when the appropriate
hardware component is available.
Control sample processing, page 637
Calibration sample processing, page 638
Reagent and sample manager (RSM) processing priorities, page 638
Reagent and sample manager (RSM) sample processing, page 639
page 641
Reagent inventory processing, page 643

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Control sample processing

When multiple reagent cartridges for an assay are loaded on the system and before the
sampling process for a control order begins, the system determines which cartridges to use
based on the following configuration parameter and the Reagent Selection options that are
chosen for the order.
Run Controls for • If the assay is configured to run controls for onboard
Onboard Reagents by reagents by cartridge, the control order runs for each
cartridge of the corresponding reagent for each module.
• If the assay is configured to run controls for onboard
reagents by lot, the control order runs only for one
cartridge of each reagent lot for each module.
NOTE: Control orders for calculated assays are processed independently of the configuration
parameter. The system software automatically runs one replicate of each constituent assay for
one reagent cartridge on each module.
All Reagent Selection options require the following conditions for the control order to process:
• A calibration for the assay either is available with a status of Active or Pending QC, or is in
process.
• Reagent cartridges with the same lot as the available or in-process calibration are loaded on
the system.
The following list provides descriptions of the Reagent Selection options:
Module For each selected module, the system runs the control order
for each reagent lot or cartridge, based on the Run Controls
for Onboard Reagents by configuration parameter, if the
assay is configured for use on each selected module.
NOTE: The Module option is available only for multimodule
systems that have more that one module of the same type.
Auto The system runs the control order on each module with the
assay that is configured for use and for each reagent lot or
cartridge, based on the Run Controls for Onboard Reagents
by configuration parameter.
Select cartridge The system runs the control order for the selected reagent
cartridge if the cartridge status is OK, Low Alert, Overridden,
Disabled, or Mixing and the assay is configured for use on the
module where the selected reagent cartridge is located.

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Calibration sample processing

When multiple reagent lots for an assay are loaded on the system and before the sampling
process for a calibration order begins, the system determines which lots to calibrate by using the
calibration status of the reagent lot and the selected order options for the reagent and module
according to the following rules.
NOTE: For c‑series photometric assays that are configured to perform calibrations by cartridge,
the reagent lot is composed of the reagent lot number and the reagent cartridge serial number.
This combination of the two numbers is evaluated for calibration processing. The calibration-by-
cartridge option is unavailable for i‑series assays.
If the Reagent Selection option is Module, the following conditions are applicable for each
selected module that has an instrument status of Running or Processing when the calibrator
samples are scanned:
• The system calibrates all reagent lots that are loaded on the system when no reagent lots
for the assay have a calibration status of Active or Pending QC.
• The system calibrates all reagent lots that are loaded on the system when all reagent lots
• The system calibrates only the reagent lots that are loaded on the system that do not have
a calibration status of Active or Pending QC when some reagent lots for the assay have a
calibration status of Active or Pending QC and some do not.
NOTE: The Module option is available only for multimodule systems that have more than one
module of the same type.
If the Reagent Selection option is Auto, the following conditions are applicable for all modules
that have an instrument status of Running or Processing when the calibrator samples are
scanned:
• The system calibrates all reagent lots that are loaded on the system when no reagent lots
• The system calibrates all reagent lots that are loaded on the system when all reagent lots
• The system calibrates only the reagent lots that are loaded on the system that do not have
a calibration status of Active or Pending QC when some reagent lots for the assay have a
calibration status of Active or Pending QC and some do not.
Reagent and sample manager (RSM) processing priorities

After a rack or cartridge is loaded on the reagent and sample manager (RSM), the RSM
transport moves the rack or cartridge to or from a processing module location. The RSM
transport performs the processing priorities in the following order:

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1. Unload a completed sample rack from a module-specific sample positioner.

2. Load priority retest sample racks on the designated module-specific sample positioner in the
order in which the racks are presented to the RSM.
NOTE: If both lanes of the module-specific sample positioner are occupied, when a routine
sample rack is available, the rack is removed from the sample positioner and processing for
the routine sample is delayed until the sample positioner is available.
3. Load priority sample racks, vial racks, or onboard vial racks on the designated module-
specific sample positioner in the order in which the racks are presented to the RSM.
NOTE: If both lanes of the module-specific sample positioner are occupied, when a routine
sample rack is available, the rack is removed from the sample positioner and processing for
the routine sample is delayed until the sample positioner is available.
4. Load priority cartridges or onboard vial racks in the reagent storage area in the order in
which the cartridges or racks are presented to the RSM.
5. Load routine retest sample racks on the designated module-specific sample positioner.
6. Load routine sample racks on the designated module-specific sample positioner in the order
in which the racks are presented to the RSM.
7. Load routine cartridges in the reagent storage area in the order in which the cartridges are
presented to the RSM.
8. Unload cartridges or onboard vial racks from the reagent storage area.
NOTE: If the Alinity ci‑series is connected to a laboratory automation system (LAS), specimen
interleaving occurs.
Sample processing for specimens that are currently aspirated at the sample positioner is
completed before sample processing begins for an LAS specimen.
If an LAS specimen is being aspirated, the system completes sample processing before the
system begins to process a rack on the sample positioner.
Reagent and sample manager (RSM) sample processing

After a sample rack or vial rack for immediate use is loaded on the loading area of the reagent
and sample manager (RSM), the rack is moved to the aspiration location.
On a multimodule system, samples are routed to the first available processing module. If multiple
processing modules are available, the system first routes the samples to the numbered module
that has the lowest number.

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Figure 149: RSM sample processing
After a sample rack or a vial rack for immediate use is loaded on the loading area of the RSM
and a run is initiated, the RSM performs the following functions:
1. The RSM transport moves to the position of the first rack according to the system software
prioritization and picks up the rack. The status indicator on the RSM is amber, which
indicates that the rack is being accessed by the RSM transport.
2. The RSM transport positions the rack for the bar code reader to identify the rack ID and the
SID. Then the RSM transport returns the rack to its original position on the loading area.
3. The system software determines if an order is present in the software for each sample in
the rack. If no orders are present and the system is configured for host order queries, the
user interface computer sends a query to the host.
4. The RSM transport moves the rack to an available sample positioner lane if an order is
present or a query returns a test order. If a sample positioner lane is not available, the rack
remains on the loading area until a sample positioner lane is available.
5. The sample positioner moves the rack to the aspiration position.
6. The sample pipettor aspirates the sample.

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7. The sample positioner moves the rack to the transport position.

8. The RSM transport picks up the rack and, if necessary, moves the rack to a sample
positioner on the next processing module if a sample positioner is available. Then the RSM
transport returns the rack to its original position on the loading area.
NOTE: If a sample positioner is not available on the next processing module, the rack is
returned to its original position on the loading area until a sample positioner on the next
module is available.
9. The status indicator blinks green after all samples in the rack are aspirated.
If the system is configured to reposition samples for reruns automatically, the status
indicator is amber until all reruns are aspirated.
If tests are added to a sample or reruns are requested before the sample is unloaded, the
status indicator changes from blinking green to amber while the sample is reaspirated.
Reagent and sample manager (RSM) sample processing for onboard calibrators and
controls
After an onboard vial rack is loaded on the loading area of the reagent and sample manager
(RSM) and a run is initiated, the required sample processing is completed and the rack is loaded
in the reagent carousel.
On a multimodule system, samples are routed to the first available processing module. If multiple
processing modules are available, the system first routes the samples to the numbered module
that has lowest number.
NOTE: All vials in the onboard vial rack must meet the criteria for onboard storage.
Onboard vial racks are processed as priority racks regardless of the position of the rack on the
loading area of the RSM.
Onboard stability tracking occurs when the software schedules the rack to be loaded on the
system. The onboard stability tracking of calibrators and controls continues when the rack is
unloaded.
After an onboard vial rack is loaded on the loading area of the RSM and a run is initiated, the
RSM performs the following functions:
1. The RSM transport moves to the position of the first onboard vial rack according to the
system software prioritization and picks up the rack. The status indicator on the RSM is
amber, which indicates that the rack is being accessed by the RSM transport.
2. The RSM transport positions the onboard vial rack for the bar code reader to identify the
rack ID and the SID. Then the RSM transport returns the rack to its original position on the
loading area.

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3. The system software determines if an order is present in the software for each calibrator set
and control in the onboard vial rack. If no orders are present, the samples are evaluated to
determine whether automated orders for calibration sets and controls can be created.
4. If no automated orders are created, the onboard vial rack is scheduled to be loaded in the
reagent carousel. The RSM transport loads the onboard vial rack on the reagent positioner
according to the processing priorities of the RSM.
5. The reagent transport moves the onboard vial rack to an available position in the reagent
carousel for storage.
NOTE: If the onboard vial rack cannot be loaded in the reagent carousel, the rack remains
in its original position on the loading area and the status indicator blinks green.
6. If sample processing is required as a result of existing or automated orders, the onboard vial
rack is moved to an available sample positioner lane and sample processing is completed
according to the processing priorities of the RSM.
7. After all sample processing is completed, the onboard vial rack is processed as described in
steps 4, page 642 and 5, page 642.
Racks, page 157
Onboard storage criteria for calibrator and control vials

Onboard vial racks that contain bar-coded calibrator and control vials are loaded in the reagent
carousel for onboard storage if the following criteria are met. Vials that are ineligible for onboard
storage can be processed in a vial rack or can be pipetted into sample cups and processed in a
sample rack.
1. All vials that are needed for a complete calibrator set are loaded in the onboard vial rack.
2. Each vial in a calibrator set has the same lot number and the lot number is configured as
the default.
3. Each calibrator set is configured as stored in the reagent carousel.
4. Each control vial is configured as stored in the reagent carousel.
5. A position in the reagent carousel is configured for the onboard storage of an onboard vial
rack and is available to receive the rack.
6. All vials have at least 48 hours before the lot expiration and onboard stability expiration are
exceeded.
NOTE: A status of Overridden does not meet this requirement.
7. All calibrator vials have a vial status of OK.
8. No control vials have a vial status of Expired, Low Alert, or Empty.
9. None of the vials have been processed previously in a different onboard vial rack.

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10. The bar code label of each vial in a rack matches the lot number of a configured calibrator
or control.
Racks, page 157
Reagent inventory processing

When multiple reagent cartridges with active calibrations are loaded on the Alinity ci‑series, the
following criteria are evaluated in this order to determine which one to use to process a test:
1. The reagent cartridge nearest to its open stability expiration date
2. The reagent cartridge nearest to its reagent lot expiration date
3. The reagent cartridge with the fewest remaining tests
NOTE: Regardless of these criteria, available reagent cartridges are used before cartridges that
have a status of Mixing.
When more than one reagent cartridge is required for an assay, the cartridges are linked
together when loaded on the system and are evaluated as a set.
Constituents of calculated assays that use the same reagent cartridge must be run with the
same reagent lot.
Create a single specimen order, page 682
Load samples into sample racks

Perform this procedure to load aliquot tubes, primary tubes, or sample cups that contain samples
(specimens, calibrators, or controls) into sample racks.
Before loading samples into the sample rack, become familiar with sample specifications and
requirements and sample bar code label requirements.
1. If loading calibrators or controls, verify that they are within the expiration date on the bottle
label. Do not use calibrators or controls that are expired.

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2. Refer to the assay documentation to determine the minimum sample volume that is required
in the sample cup for the tests to be processed.
NOTE: The minimum sample volume information is printed in the Order List Report.
3. Use the sample gauge to verify that the sample volume in an aliquot tube is adequate:
a. Load the aliquot tube into the sample rack so that the sample volume is visible in the
sample rack window [1].
b. Verify that the amount of sample in the aliquot tube exceeds the 8 mm sample gauge
line [2].
IMPORTANT: Do not use the sample gauge to verify aliquot tube volumes for c‑series
whole blood applications.
4. Verify that the sample volume above the separation point (clot, gel separator, or plasma or
red cell interface) in a primary tube is a minimum of 8 mm.

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5. Use the sample cup volume graduation marks to verify that the sample volume in a sample
cup is adequate.
6. If loading non-bar-coded samples, print the Order List Report to ensure that each sample is
loaded in the correct rack and position.
IMPORTANT: The operator has a responsibility to load the correct sample in the correct
rack and position.

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7. Load the sample into the sample rack so that the sample bar code, if used, is visible in the
sample rack window and the bar code fills the width of the window.
IMPORTANT: If loading sample cups or tubes, ensure that they are pushed down
completely in the sample rack and they are not tilted.
Avoid splashing the sample outside the sample cups or tubes.
Prepare and load calibrator and control vials into vial racks for immediate use
Prerequisite For instructions for calibrator or control handling and use, see
Required instrument • Processing module: Running or Processing
status
Perform this procedure to prepare and load calibrator or control vials for assay processing on
the Alinity ci‑series.

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NOTE: To ensure correct in-use stability tracking status, do not move the vials to a processing
module that is controlled by a different system control module.
In-use stability tracking occurs after the vial is scanned by the RSM bar code reader. After the
vial is removed from the RSM, the timer for in-use stability tracking stops.
1. Verify that the calibrators or controls are within the expiration dates on the vial labels. Do
not use calibrators or controls that are expired.
NOTE: When a calibrator or control vial is scanned by the RSM bar code reader, the
Alinity ci‑series tracks and maintains a record of the calibrator lot number and expiration
date or the control lot number and expiration date.
2. Open each vial and discard the caps.
3. Inspect each vial for bubbles. Remove bubbles with a clean applicator stick before
performing sample processing. Use a new applicator stick for each vial to prevent cross
contamination.
4. Place each vial in the white vial rack with standoffs so that the vial bar code is visible in the
rack window and the bar code fills the width of the window.
NOTE: For c‑series assays that use a blank calibrator set, only one blank calibrator vial is
required for each vial rack when more than one assay is calibrated. The vial rack must
contain a complete calibrator set for each assay.
5. Load the vial rack on the RSM.

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Initiate or resume sample processing
Required instrument Stopped, Idle, or Pausing

status
Perform this procedure to process a run after ordering and loading samples or to resume sample
processing after pausing or stopping the processing module or the reagent and sample manager
(RSM).

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NOTE: Verify that each processing module has adequate supplies and reagents before initiating
or resuming sample processing.
3. Tap Run.
Verify the reagent carousel inventory, page 622
Verify the supply and waste inventory, page 579
Create a bar-coded batch specimen order, page 684
Add a test to a specimen order, page 689
Suspend and access a sample that has tests in process
Required instrument Running

status
Perform this procedure to suspend sample processing of a rack to immediately access a
sample. Sample processing cannot be suspended for a sample in the following instances:
• When the sample is part of an in-process bar-coded batch
• When the sample is located in an onboard vial rack
• When the sample is located on the laboratory automation system
NOTE: When a rack is suspended, the processing module completes sample aspiration of the
current sample. After sample aspiration is completed, the rack is returned to its original position
on the reagent and sample manager (RSM), and any scheduled tests become exceptions and
are not processed.
1. On the menu bar, tap Sample Status.
2. Under SID Name, tap a sample.
NOTE: To filter the list of results, tap a tab (or tap Search).
3. Tap Suspend.

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The rack is returned to its original position on the RSM.
Sample Status screen, page 693
Unload samples from the reagent and sample manager (RSM)

• Blinking green
• Steady green
Perform this procedure to unload samples from the RSM when the samples are not needed on
the system.
IMPORTANT: When transporting or unloading racks, avoid splashing the samples outside the
1. Slide the rack, or the tray that contains the rack, out of the RSM.
2. Remove the samples from the rack.
3. Dispose of sample cups in a biohazardous waste container.
4. Store the remaining samples according to laboratory guidelines.
Unload vials from the reagent and sample manager (RSM)

• Blinking green
• Steady green

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Perform this procedure to unload calibrator or control vials from the RSM when the calibrator or
control is not needed on the system.
IMPORTANT: When transporting or unloading racks, avoid splashing the calibrators or controls
outside the vials.
1. Slide the rack, or the tray that contains the rack, out of the RSM.
NOTE: In-use stability tracking occurs after a vial is scanned by the bar code reader. After
the vial is removed from the RSM, the timer for in-use stability tracking stops.
For information about reagent in-use stability, see the assay documentation.
2. Remove the vials from the rack.
NOTE: Racks that contain vials can be placed in refrigerated storage. To maintain reagent
in-use stability for storage, each vial must contain a replacement cap before the vials are
stored.
3. Place a new replacement cap on each vial to store the vials for future use.
NOTE: Empty vials without replacement caps can be discarded in a biohazard waste
container.
4. Store the vials in refrigerated storage according to instructions in the assay documentation.

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Specimen, calibration, and control orders Section 5
Specimen, calibration, and control orders

Order requests for specimens, calibrator samples, and quality control samples can be created
automatically or manually by an operator.
Automated ordering, page 652
Automated ordering
Order requests for specimens, controls, and calibrations can be created automatically. The
following list describes automated ordering capabilities according to sample type:
Specimen Automated specimen ordering is available by using host

computer downloads, host order queries, or the retest option
of the Alinity ci‑series.
Control Automated control ordering is available by configuring the

system parameters of the Alinity ci‑series.
Calibration Automated calibration ordering is available by configuring the

system parameters of the Alinity ci‑series.
Host orders
Automated specimen ordering is available by using host computer downloads or host order
queries. For automated ordering by a host computer, the system must be configured to
communicate with the host.
NOTE: Host orders are not generated for an assay that has an assay status of Correlation.
Host computer Specimen orders are downloaded from the host computer to
download the user interface (UI) computer. When the bar code reader
scans a bar-coded specimen, and the host computer has

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Section 5 Specimen, calibration, and control orders
downloaded an order to the UI computer, the system

processes the order.
NOTE: If the system is configured for a laboratory automation
system (LAS) track, when the LAS sends sample information
to the UI computer and the host computer has downloaded an
order to the UI computer, the system processes the order.
Rerun orders that are sent by the host computer are rerun if
the specimen has not been unloaded from the reagent and
sample manager (RSM). Orders that are downloaded can be
viewed on the Orders screen.
Host order query A specimen order is downloaded from the host computer to
the UI computer after a request is sent from the UI computer.
The following activities occur after a specimen is loaded on
the RSM or the LAS:
• When the RSM bar code reader scans a bar-coded
specimen on the RSM, and an order does not exist on the
UI computer, the UI computer sends a query to the host
computer.
• When the LAS sends specimen arrival information to the
UI computer and an order does not exist, the UI computer
sends a query to the host computer.
If the host computer has an order request for the specimen,

the order is sent to the UI computer. When the order is
received, the order can be viewed on the Orders screen.
If the host computer has no order requests for the specimen
(or no record of the sample), a message is generated and is
displayed on the Interfaces tab of the System Logs screen.
NOTE: If the host computer creates rerun orders, the orders
must be downloaded to the UI computer. The UI computer
does not send queries for rerun orders.
Automated control ordering

Automated control ordering is the process that the system uses to order quality control tests
automatically. The control SID is associated with a predefined test list. Automated control orders
are created in the following ways:

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• When a control sample bar code label from an onboard vial rack, a vial rack, or a sample
rack is scanned
• When the system software periodically evaluates the control vials that are stored in onboard
vial racks in the reagent carousel
• When the configured time interval or test interval is exceeded
Evaluation of controls for automated orders
Controls are evaluated for automated orders in three ways:

• When they are scanned by the reagent and sample manager (RSM)
• Every 15 minutes when they are stored on the system and the instrument status of the
processing module is Processing
• Every 15 minutes when they are stored off the system and at least one processing module
has an instrument status of Processing
Evaluation by the RSM
Control vials in vial racks and onboard vial racks and bar-coded samples in sample racks are
evaluated when they are scanned by the RSM bar code reader for each processing module that
has an instrument status of Running or Processing.
The rack ID of a vial rack or an onboard vial rack notifies the system software that calibrators or
controls are loaded in the rack. The SID for controls in a vial rack or an onboard vial rack is
composed of the control lot number, the control level, and the vial serial number. The SID for
controls in a sample rack is composed of the control lot number and level, and QQQ is added to
the beginning of the SID.
The scanned bar code is compared to the configured single-constituent and multiconstituent
controls. If the bar code corresponds to a configured control lot number and level, and an order
for the control is present in the system software, the order is completed. The order is not
completed for a control vial that has a vial status of Empty, Expired, or LLS Error. Orders for
assays that are disabled for onboard use in a multiconstituent control that is stored on the
reagent carousel become exceptions when the orders are run.
If no control order is present in the system software and the control vial meets the criteria to
create an automated order, the system automatically creates the order and processes the tests
for the SID. The order that is created can be viewed on the Orders screen.
Evaluation of controls stored on the system
Control vials that are stored on the system are evaluated for automated control orders every 15
minutes on each processing module that has an instrument status of Processing (and when the
instrument status transitions from Stopped or Idle to Running or Processing).
On multimodule systems, automated control orders are evaluated on all processing modules on
which the analyte can be run.

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NOTE: Automated control orders are not created for multiconstituent control assays that are
disabled for onboard use when the control is located in an onboard vial rack that is assigned a
position in the reagent carousel.
Evaluation of controls not stored on the system
After the evaluation of control vials that are stored on the system is completed, control vials that
are stored off the system are evaluated for automated control orders. The evaluation occurs
every 15 minutes when at least one processing module has an instrument status of Processing
(and when the instrument status transitions from Stopped or Idle to Running or Processing). If
one processing module has an instrument status of Processing, the evaluation is performed for
all processing modules that have an instrument status of Running or Processing. Only the default
lot number is evaluated and only for those controls that have the Automated parameter on the
Control Configuration screen configured as Yes. A notification instructs the operator to load the
control vials and orders are created when the vials are loaded.
Notification does not occur in the following instances:
• When a control order is present for the specified assay and control level
• If the control lot number is expired
• When no reagent cartridge is available for the assay
Creation of automated orders when the Automated parameter is enabled
Automated control orders are created for controls that have the Automated parameter on the
Control Configuration screen configured as Yes if the following criteria are met:
• No order has been created since the configured shift start time.
The order is created for all analytes that use the control lot number and level with an
onboard reagent lot or reagent lot and cartridge combination for assays configured to run
controls by using a cartridge.
• The time interval or test interval has been exceeded.
The order is created for each onboard reagent lot or reagent lot and cartridge combination.
NOTE: The time interval is determined from the configured shift start time and resets daily
at the shift start time. Orders that are created when the time interval is exceeded are
created independently from manual orders and those orders created as the result of a
configured test interval.
Orders are created for a calculated assay only when the Start Time parameter on the
Control Configuration screen is defined for the control level.
After the initial configuration, the test interval for an assay begins when an order for the
control lot number and level is completed without a Westgard failure or a quality control
(QC) range failure. The interval is based on the number of specimen tests initiated for the
assay since the last completed control result for the assay and control level. The test
interval resets after every completed control result for the control level and analyte.

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• The most recent control result for the analyte generated a Westgard failure or a QC range
failure.
Orders are created for the onboard reagent lot or reagent lot and cartridge combination.
NOTE: Orders are not created if the control is in an onboard vial rack that has been
assigned a position in the reagent carousel.
• A usable calibration is present for the assay that has not been verified by quality control or
a calibration order for the assay has a status of Scheduled or Running.
Creation of automated orders when the Automated parameter is disabled
Automated control orders are created for controls that have the Automated parameter on the
Control Configuration screen configured as No when control samples are scanned by the RSM
bar code reader if no order has been created since the configured shift start time.
NOTE: The order is created for all analytes that use the control lot number and level if an
onboard reagent lot or reagent lot and cartridge combination is present.
Regardless of the configured option for the Automated parameter, automated control orders are
not created in the following instances:
• A control order that has a status of Pending is present.
• The reagent cartridge status is Disabled.
• The control vial status is Empty, Expired, or LLS Error.
• Assays that have an assay status of Correlation are present.
Edit a quality control, page 353
Automated calibration ordering

Automated calibration ordering is the process that the system uses to create calibration orders
automatically. Automated calibration orders are created in the following ways:
• When a bar code label from an onboard vial rack or a vial rack is scanned
• When the system software periodically evaluates the calibrator vials that are stored in
onboard vial racks in the reagent carousel
Calibrator vials in vial racks and onboard vial racks are evaluated when they are scanned by the
RSM bar code reader for each processing module that has an instrument status of Running or
Processing.

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The rack ID of a vial rack or an onboard vial rack notifies the system software that calibrators or
controls are loaded in the rack. The SID for calibrators in a vial rack or an onboard vial rack is
composed of the calibrator lot number and the vial serial number.
The scanned bar code is compared to the configured calibrator set. If the bar code corresponds
to a configured calibrator lot number and an order for the calibrator set is present in the system
software, the order is completed. No automated orders are created. The order is not completed
for a calibrator vial in the calibrator set that has a vial status of Empty, Expired, or LLS Error.
If no calibration order is present in the system software and the calibrator vial meets the criteria
to create an automated order, the system automatically creates and processes the order. The
order that is created can be viewed on the Orders screen.
NOTE: For c‑series assays that are used for full and adjustment calibrations, calibrator vials are
evaluated first for the full calibration. If orders are not created for the full calibration, the
adjustment calibration is evaluated.
NOTE: When a blank adjustment is performed for c‑series assays that use a blank calibrator set,
the system accepts a vial rack that contains only the blank calibrator, with or without other
calibrators. For a full calibration, only one blank calibrator is required for each vial rack when
the vial rack is loaded with more than one complete calibrator set.
NOTE: Calibrator vials that are stored on the system are evaluated for automated calibration
orders every 15 minutes on each processing module that has an instrument status of Processing
(and when the instrument status transitions from Idle to Running or Processing).
On multimodule systems, automated calibration orders are evaluated on all processing modules
on which the analyte can be run.
Automated calibration orders are created if the following criteria are met:
• No calibration with a status of Active or Overridden is present for the assay.
Orders are created for each uncalibrated onboard reagent lot or reagent lot and cartridge
combination for assays configured to run calibrations by using a cartridge.
• All onboard reagent lots or reagent lot and cartridge combinations have a status of Active or
Overridden, but one or more lots or lot and cartridge combinations will expire within 1 hour if
calibrators are stored on the reagent supply center or within 8 hours for all other calibrators.
Orders are created for the onboard reagent lots or reagent lot and cartridge combinations
that will expire if a calibration is not in process.
• The calibrator is a single-constituent calibrator, all onboard reagent lots or reagent lot and
cartridge combinations have a status of Active or Overridden, and no calibrations are in
process.
Orders are created for all onboard reagent lots or reagent lot and cartridge combinations.
NOTE: Order are not created if the calibrator is in an onboard vial rack that has been
assigned a position in the reagent carousel.
• The calibrator is in an onboard vial rack and a calibration that has a status of Active is
present, but the calibration will expire before the onboard vial rack is evaluated again, and
no calibrations are in process.

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The order is created for each onboard reagent lot or reagent lot and cartridge combination
that will expire.
• The assay is a c‑series assay that uses the factor data reduction method, and the
calibration is expired or will expire before the next evaluation interval.
Orders are created for all onboard reagent lots or reagent lot and cartridge combinations.
Automated calibration orders are not created in the following instances:

• A calibration order for the same assay is present.
• The reagent cartridge status is Disabled.
• The vial status of any calibrator vial in the calibrator set is Empty, Expired, or LLS Error.
• Assays that have an assay status of Correlation are present.
Create a new calibrator master lot (i‑series), page 313
Automated retest of specimens

Automated retest is the process that the system uses to generate rerun orders for specimen
tests automatically. For each test, the system can generate a maximum of four automatic rerun
orders.
Retest rules are not applied to the following items:
• Calibrator tests
• Control tests
• Tests that are performed with a manual dilution
• Assays that have an assay status of Correlation
• Tests that are performed from a specimen that is run on a laboratory automation system
Automated retest has two steps:

1. The system compares test results to the configured retest rules, starting with the first rule. If
a test result meets the criteria of a retest rule, the system generates a rerun order without
further evaluation of the configured retest rules.
NOTE: If the rerun order that is generated is used for a different assay, the order is
suppressed if a test for the specimen is present that has a status of Pending, Scheduled,
Running, or Complete. The order is not suppressed if the test is a calculated assay or the
system-ordered constituent of a calculated assay.

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The rerun order is scheduled and uses the Automatic option of reagent selection. The rerun
order is displayed with the R processing code on the Sample Status screen, the All Orders
tab of the Orders screen, and the Rerun tab of the Orders screen.
The system can be configured to reposition specimens for retest automatically. Specimens
that are loaded on the reagent and sample manager (RSM) are moved to the sample
aspiration point and rerun orders are generated automatically. If the system is not
configured to reposition specimens automatically, the specimens must be loaded manually
on the RSM.
2. The system compares the specimen rerun test results to the configured retest rules. If a
rerun test result meets the criteria of a retest rule, the system generates a second rerun
order. This rerun order is displayed and processed in the same manner as the first order.
NOTE: The system suppresses a second rerun order if the order is based on the same
retest rule criteria as the first rerun order.
Configure reagent and sample manager module settings, page 189
Orders screen
On the Orders screen, the operator can view specimen, control, calibration, and rerun orders.
• Find information about a specific order based on specified search criteria.
• Access the order information.
• Add a comment to a test order.
• Delete an order.
• Create a new specimen order, control order, or calibration order.
Orders screen, Search flyout element descriptions, page 661
Order Details screen, page 664
Create Order screen, page 668
Descriptions of test statuses, page 691
Descriptions of processing codes, page 691
Delete a test from a sample order, page 692

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Orders screen element descriptions
All Orders tab, Rerun tab, Specimen tab, Control tab, Calibrator tab
Displays rerun, specimen, control, and calibrator test orders. Order status information can be
filtered by order type by selecting the Rerun tab, Specimen tab, Control tab, or Calibrator tab.
Elements
R/P Displays the rack ID (R) and position (P) number. The rack/
position can be sorted in ascending order, first
alphanumerically by rack, and then numerically by position.
system (LAS) and the specimen is run on the LAS, the R/P is
displayed as LAS/1.
SID Displays the sample identification of the order, which can be

one of the following items:
• The bar code number or identification assigned to the
specimen.
• The control lot number and control level number. Bar-
coded controls include a serial number when quality
controls are run in a vial rack. Bar-coded controls include
the prefix QQQ followed by the control lot number and
level when the controls are run in a sample rack.
• The calibrator lot number and calibrator level number.
The SID can be sorted alphanumerically in ascending order.
Name Displays the name, which can be one of the following items:
• The patient's name.
• The calibrator or calibrator set name, CAL (only for
i‑series), and the calibrator level for calibration orders.
Assay Displays the name of the test ordered.
Test Type Displays the sample type for the order: Specimen, Control, or
Calibrator. The Test Type column is displayed only on the All
Orders tab and the Rerun tab.

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Status Displays the current test status (Pending, Scheduled, Running,

In Process, or Complete) of the assay ordered.
Time Displays the estimated time that the order will be completed
(in a 24-hour format). Time information is displayed for all
samples with a status of Running.
Code Displays the processing codes to indicate the processing

conditions.
Function buttons
Create Order Navigates to the Create Order screen.
current screen.

selected items.
Orders screen, Search flyout element descriptions

In the Search flyout of the Orders screen, the operator can enter specific data that is used to
filter the data on the screen.
Elements
Module Displays check boxes that are used to search by the module.
The module number for the specimen results of calculated

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assays is 6 (the system control module). The module number

for control results of calculated assays is the processing
module used to produce the constituent results.
Name Displays a text box that is used to search by the name, which
can be one of the following items:
SID Displays a text box that is used to search by the sample

identification of the order, which can be one of the following
items:
specimen.
Rack Displays a text box that is used to search by the rack

identification number.
PID Displays a text box that is used to search by the patient

Position Displays a drop-down list that is used to search by the rack

position.
RSM Position Displays a drop-down list that is used to search by a position

on the reagent and sample manager.
Assay Displays a text box that is used to search by the assay name.
Time From Displays a spin box that is used to enter a search start time.

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Time To Displays a spin box that is used to enter a search end time.
Status Displays check boxes that are used to search by the test
status. The Search flyout has four test statuses:
• Pending
• In Process
• Scheduled
• Running
Test Type Displays check boxes that are used to search the results for a
specific sample type. The Search flyout has three test types:
• Specimen
• Control
• Calibrator
Function buttons




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Order Details screen

On the Order Details screen, the operator can view the details for a specimen test order, a
control test order, or a calibrator test order.
The operator can add a comment to a specimen test order, a control test order, or an individual
calibrator test order.
Order Details (Single Specimen, Control, and Calibrator) screen element descriptions, page 664
Order Details (Bar-Coded Batch Specimen) screen element descriptions, page 666
Add a comment to an order, page 668
Order Details (Single Specimen, Control, and Calibrator) screen element descriptions
The Order Details screen displays the order details for specimens, controls, and calibrators.
Test Information area
SID Displays the sample identification.
Rack/Position Displays the rack ID and position number.

system (LAS) and the specimen is run on the LAS, the rack ID
and position number are displayed as LAS/1.

system when the test was ordered.
Test Type Displays the sample type for the test: Specimen, Control, or
Calibrator.
Module/Position Displays the module number and position of the rack on the
loading area.
Time of Completion Displays the date and time that the tests in process were
completed.
Status Displays the current status (Pending, Scheduled, Running, In

Process, or Complete) of the assay ordered.
PID Displays the patient identification. This element is displayed

only for specimens.

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Gender Displays the gender of the patient. This element is displayed

only for specimens.
Control Lot Displays the lot number of the control. This element is
displayed only for controls.
Calibrator Lot Displays the lot number of the calibrator. This element is
displayed only for calibrators.
completed.
Name Displays the name of the patient.
Date of Birth Displays the date of birth for the patient. This element is
displayed only for specimens.
Draw Date/Time Displays the date and time that the sample was drawn. This
element is displayed only for specimens.
Lot Expiration Displays the date and time of the control or calibrator lot
expiration. This element is not displayed for specimens.
Assay Information area
Dilution Displays the type of dilution used to process the test.
Codes Displays the processing codes associated with the test.
Reference Assay Displays the photometric reference assay.
Reagent Information area
Reagent Lot Displays the master lot number for the reagent.
Reagent SN Displays the serial number of the reagent cartridge.

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Reagent Lot Displays the expiration date of the reagent cartridge.

Expiration
Additional Information area
Doctor Displays the name of the patient's doctor. This element is

Location Displays the location associated with the patient. This element
is displayed only for specimens.
test.
Function buttons


Order Details (Bar-Coded Batch Specimen) screen element descriptions

The Order Details screen displays the order details for a bar-coded batch specimen order.
Batch Information area
Starting SID Displays the SID of the first sample in the batch order.
Ending SID Displays the SID of the last sample in the batch order.

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system when the batch was entered.
Test Type Displays the sample type for the test: Specimen.
Samples Scanned Displays the number of samples scanned in the batch order
by the RSM bar code reader.
Status Displays the current status (Pending or In Process) of the

batch order.
Batch Name Displays the name of the batch. The default batch name is
BatchXX:XX:XX, where XX:XX:XX is the time that the batch
was ordered in hours, minutes, and seconds.
Assay Displays the name of the assay file that is part of the batch
order.
Replicates Displays the number of replicates for the specific assay and
dilution factor.
Module Selection Displays the module number of the processing module used
to perform the assay. If only one processing module of the
same type is configured for a system or if a specific module
is not identified, the module selection is Auto.
batch order. Comments are displayed and are printed with
each sample order in the batch. Comments can have a
Function buttons


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Add a comment to an order

Perform this procedure to add a comment to a specimen order, a bar-coded batch order, a
control order, or a calibration order.
1. On the menu bar, tap Orders.
2. In the list on the Orders screen, tap one or more tests (or tap Select All).
NOTE: To filter the list, tap a tab (or tap Search).
3. Tap Details.
4. In the Comment box on the Order Details screen, type additional information that is
associated with the test.
NOTE: Comments are displayed and are printed with the test. In addition, comments for
samples are displayed if comments were entered when the order was created.
For batch orders, if the test status is In Process, a comment for the batch order cannot be
entered. However, a comment can be entered when the batch order is created or if the test
status is Pending.
5. If more than one order was selected, tap Next or Previous to display each order, and then
type a comment for each order.
6. To save the comments, tap Done.
Create Order screen

On the Create Order screen, the operator can create an order when the following situations
occur:
• The system is not connected to a host computer.
• The host computer is not functioning.
• An additional test is needed.

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• Add information that is specific to a specimen.

• Add assay options that are specific to a test.
Create Order screen, Specimen tab, Single Specimen element descriptions, page 669
Create Order screen, Specimen tab, Bar-Coded Batch element descriptions, page 671
Create Order screen, Specimen tab, Patient Details flyout element descriptions, page 673
Create Order screen, Specimen tab, Assay Options flyout element descriptions, page 675
Create Order screen, Control tab element descriptions, page 676
Create Order screen, Control tab, Assay Options flyout element descriptions, page 677
Create Order screen, Calibration tab element descriptions, page 679
Create Order screen, Calibration tab, Assay Options flyout element descriptions, page 681
Create a bar-coded batch specimen order, page 684
Create Order screen, Specimen tab, Single Specimen element descriptions

On the Specimen tab, the operator can create a single specimen order when the Single
Specimen option in the Order Type area is selected.
Order Type area
Single Specimen Orders one or more tests as a single sample. (Default)

option
Bar-Coded Batch Orders the same tests for multiple bar-coded specimens.
option
Sample Data area
SID Displays a text box that is used to enter the bar code number
or identification assigned to the specimen. The SID can have
a maximum of 20 alphanumeric characters, which are defined
by Abbott Laboratories as A through Z, a through z, 0 through
9, and special characters , / > < ? ; : ] [ \ } { ' - = ~ ! @ # $ %
^ & * ) ( _ + and <space>.
IMPORTANT: Contact the host computer vendor to verify if
the host computer handles special characters (if used in

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SIDs) as characters rather than functions. Some computers

may interpret special characters as a line return, line feed,
delimiter, or wildcard character.
Rack Displays a text box that is used to enter the rack ID in which
samples are placed for processing. This element is optional
when bar-coded samples are used.
Position Displays a text box that is used to enter the position of the
sample in the rack. This element is optional when bar-coded
samples are used.
Manual Dilution: 1: Displays a text box that is used to enter the dilution factor to
calculate the sample concentration automatically and to
report the result.
Designate Sample Displays a check box that is used to display the S code on
STAT the Orders screen, the Results screen, and the Sample Status
screen. The operator must priority load the samples with the S
code to process the samples first.
Comments Displays a text box that is used to enter comments for the
sample. Comments are displayed and can be printed for each
test ordered for the sample. Comments can have a maximum
of 50 characters.
Assays area
processing modules.
processing modules.
Panels Displays all assay panels that are available.
Assays Displays all assays that are available for a selected module.
Number of Selected Displays the number of assays that are selected.

Assays

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Function buttons
Order Status Navigates to the Orders screen.
Patient Details Displays the Patient Details flyout.
Assay Options Displays the Assay Options flyout.
Add Order Saves the order and clears the screen to accept a new order.
Create Order screen, Specimen tab, Bar-Coded Batch element descriptions

On the Specimen tab, the operator can create a bar-coded batch order when the Bar-Coded
Batch option in the Order Type area is selected.
Order Type area
Single Specimen Orders one or more tests as a single sample. (Default)

option
Bar-Coded Batch Orders the same tests for multiple bar-coded specimens.
option
Sample Data area
Starting SID Displays a text box that is used to enter the starting SID of the
batch to be processed. The SID can have a maximum of 20
alphanumeric characters, which are defined by Abbott
Laboratories as A through Z, a through z, 0 through 9, and
special characters , / > < ? ; : ] [ \ } { ' - = ~ ! @ # $ % ^ & * )
( _ + and <space>.

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Ending SID Displays a text box that is used to enter the ending SID of the
batch to be processed. The SID can have a maximum of 20
alphanumeric characters, which are defined by Abbott
Laboratories as A through Z, a through z, 0 through 9, and
special characters , / > < ? ; : ] [ \ } { ' - = ~ ! @ # $ % ^ & * )
( _ + and <space>.
Batch Name Displays a text box that is used to change the default name of
the batch order. The default batch name is BATCHXX:XX:XX,
where XX:XX:XX is the time that the batch was ordered in
hours, minutes, and seconds. The batch name can have a
maximum of 20 alphanumeric characters.
report the result.
Comments Displays a text box that is used to enter comments for the
batch. Comments are displayed and can be printed for each
sample ordered for the batch. Comments can have a
Assays area
processing modules.
processing modules.

Assays

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Function buttons
Add Order Saves the order and clears the screen to accept a new order.
Create Order screen, Specimen tab, Patient Details flyout element descriptions
In the Patient Details flyout on the Specimen tab, the operator can enter patient demographic
information for the specimen.
Elements
SID Displays the bar code number or identification assigned to the

specimen.
PID Displays a text box that is used to enter the patient

identification number. A maximum of 20 alphanumeric
characters can be entered.
NOTE: When entering a PID, enter only details that are known
to be accurate. The PID is recognized as a different and
unique patient if previously entered information is edited.
Last Name Displays a text box that is used to enter the last name of the
patient. A maximum of 20 alphanumeric characters can be
entered.
First Name Displays a text box that is used to enter the first name of the
patient. A maximum of 20 alphanumeric characters can be
entered.
M. Displays a text box that is used to enter the middle name of

the patient. A maximum of 12 alphanumeric characters can
be entered.

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Date of Birth Displays a text box that is used to enter the date of birth for
the patient. This information provides an age-specific
reference range if the assay is configured to provide
reference ranges.
Gender Displays the following options that are used to select the
gender of the patient:
• Male
• Female
• Unknown
NOTE: This option provides a gender-specific reference
range if the assay is configured to provide reference
ranges.
Draw Date Displays a text box that is used to enter the date that the
sample was drawn. To enter the draw date, tap the calendar
inside the box. To configure the month and year, tap the Left
Arrow or Right Arrow button, and then tap the day.
Time Displays a spin box that is used to enter the time that the
sample was drawn. To enter the draw time, use the system-
configured format (HH:MM) and type the time in the box or
tap the Up Arrow and Down Arrow buttons. If the system is
configured for the 12-hour clock format, tap the AM or PM
button to configure the time of day.
Location Displays a text box that is used to enter the location

associated with the patient. A maximum of 20 alphanumeric
characters can be entered.
Doctor Displays a text box that is used to enter the name of the
patient's doctor. A maximum of 20 alphanumeric characters
can be entered.
Function buttons



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Create Order screen, Specimen tab, Assay Options flyout element descriptions
In the Assay Options flyout on the Specimen tab, the operator can enter assay-specific
information for each test included in the specimen order.
Elements
Selected Assays Displays the names of the assays selected for the order.

specimen.
Module Selection Displays Auto and Module options that are used to select a
processing module that performs the assay. If only one
processing module type is configured for a system or if a
specific module is not identified, the Auto option is enabled
and the Module option is not displayed:
Auto The system scheduler selects the

processing module.
Module Displays an option for each processing

module that performs the assay.
Module options are used to override
the system scheduler.
NOTE: Module options are available
only for multimodule systems that have
more than one module of the same
type.
Dilution Protocols/ Displays the dilution protocols that are available for the
Number of Replicates selected assay and displays drop-down lists that are used to
select the correct number of replicates for the corresponding
dilution protocol.

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Function buttons



Create Order screen, Control tab element descriptions

On the Control tab, the operator can create a control order.
Orders area
Position Displays a text box that is used to enter the position of the
sample in the rack. This element is optional when bar-coded
samples are used.
Control Data area
Control Name Displays a drop-down list that is used to select the control
identification name.
Control Lot Displays a drop-down list that is used to select the control lot
number.
Control Level Displays a drop-down list that is used to select the control
level.
report the result.

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Designate Sample Displays a check box that is used to display the S code on
STAT the Orders screen, the Results screen, and the Sample Status
screen. The operator must priority load the samples with the S
code to process the samples first.
Assays area
processing modules.
processing modules.

Assays
Function buttons
Add Order Saves and navigates to the order on the Orders screen.
Create Order screen, Control tab, Assay Options flyout element descriptions
In the Assay Options flyout on the Control tab, the operator can enter assay-specific information
for each test included in the control order.

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Elements
Control Lot Displays the lot number of the control.
Control Name Displays the name of the control.
Control Level Displays the name of the control level.
Reagent Selection Displays Auto, Select Cartridge, and Module options that are
used to select a reagent cartridge and a processing module
that performs the assay. If only one processing module type is
configured for a system, the Module option is not displayed:

reagent cartridge.
Select Cartridge Displays an option that is used to

designate the reagent cartridge. When
the option is selected, the following
information is available:
• Module ID: Displays the number of
the processing module where the
reagent cartridge is located.
• Position: Displays the reagent
carousel position where the
• Reagent Lot: Displays the reagent
cartridge lot number.
• Serial Number: Displays the
reagent cartridge serial number.
• Cartridge Status: Displays the
reagent cartridge status.
Module Displays an option that is used to

designate the processing module.
When the option is selected, a check
box is displayed for each processing

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Module check boxes are used to

override the system scheduler.
NOTE: Module check boxes are
available only for multimodule systems
that have more than one module of the
same type.
Dilution Protocols/ Displays the dilution protocols that are available for the
Number of Replicates selected assay and displays drop-down lists that are used to
select the correct number of replicates for the corresponding
dilution protocol.
Function buttons



Create Order screen, Calibration tab element descriptions

On the Calibration tab, the operator can create a calibration order.
Sample Data area
Starting Position Displays a text box that is used to enter the position of the
first calibrator.
Assays area

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processing modules.
processing modules.
The default master lot number for a calibrator set is displayed
with the assay name. The default master lot number for a
blank calibrator set is listed after the calibrator set master lot
number for c‑series assays that use a blank calibrator set.
If an alternate calibrator master lot number is selected for a
manual calibration order, the selected calibrator master lot
number is displayed.
NOTE: Only the default master lot number for a blank
calibrator can be used to create a manual order.
The assay name and the calibrator master lot number are
displayed in red text if the calibrator master lot number is
expired. The assay name and the blank calibrator master lot
number are displayed in red text if the blank calibrator master
lot number is expired.
Lot numbers are not displayed for c‑series assays that use
the factor data reduction method.

Assays
Function buttons
Add Order Saves and navigates to the order on the Orders screen.

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Create Order screen, Calibration tab, Assay Options flyout element descriptions
In the Assay Options flyout on the Calibration tab, the operator can enter assay-specific
information for each test included in the calibration order.
Elements
Calibrator Lot Displays the lot number of the default calibrator or displays a
drop-down list that is used to select an alternate calibrator lot
for the selected assay if more than one lot was configured.
Calibrator Expiration Displays the expiration date of the calibrator lot.

Date
Calibration Type Displays the type of assay calibration to be performed for the
selected assay or displays a drop-down list that is used to
select an alternate calibration type if more than one type was
configured.
Reagent Selection Displays Auto, Select Cartridge, and Module options that are
used to select a reagent cartridge and a processing module
that performs the assay. If only one processing module type is
configured for a system, the Module option is not displayed:

reagent cartridge.

the option is selected, the following
information is available:

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Module Displays an option that is used to

designate the processing module.
When the option is selected, a check
box is displayed for each processing
Module check boxes are used to
override the system scheduler.
NOTE: Module check boxes are
available only for multimodule systems
that have more than one module of the
same type.
Function buttons



Create a single specimen order

Perform this procedure to create a specimen order manually.
2. On the Orders screen, tap Create Order.
3. Under Sample Data on the Specimen tab of the Create Order screen:
– Enter the SID.
IMPORTANT: To ensure that the processed tests include the correct information,
confirm that the SID is not reused before previously pending orders are completed or
are deleted.
– Enter the rack ID and the position number.
NOTE: If bar-coded samples are used, the rack ID and the position number are not
required. If a rack and a position are entered and the bar code on the sample is not

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read, the system automatically uses the scanned rack ID as the unique rack ID and the
sample is processed as entered.
– If the specimen was diluted manually, type the dilution factor in the Manual Dilution: 1:
box.
NOTE: Not all assays support manual dilutions. Assays that do not support manual
dilution are displayed as unavailable when a manual dilution is selected. For dilution
information, see the assay documentation.
– To display the STAT processing code for the SID, tap the Designate Sample STAT
check box.
NOTE: Samples that are designated as STAT must be priority loaded to be processed
as STAT samples.
4. In the Comments box, type additional information that is associated with the sample.
Comments are displayed and are printed with each test that is ordered for the sample.
5. Under Assays, tap an assay panel to run (or tap one or more of the individual assays to
run).
The number of selected assays is displayed.
Calculated.
To order a calculated assay, perform one of the following steps:
– Tap only the calculated assay.
The system automatically orders the assays that are necessary to complete the
calculation but does not release or report the results ordered by the system.
Constituent assays for some calculated immunoassays that are installed from an assay
file (assay numbers 3000 through 3999) cannot be ordered automatically by the system
and must be ordered separately. For specific assay requirements, see the assay
documentation.
– Tap the calculated assay and one or more of its constituent assays.
The system automatically orders the additional constituent assays that are necessary to
complete the calculation but does not release or report the constituent results ordered
by the system.
– Tap the calculated assay and all of its constituent assays.
The system releases and reports all results.
6. Tap Assay Options.
7. For each selected assay in the Assay Options flyout, perform the following steps if these
situations occur:
– If more than one processing module of the same type is configured for a system, under
Module Selection, tap Module to specify a processing module, and then tap the
appropriate module check boxes to override the system scheduler.

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– Under Dilution Protocols/Number of Replicates, if the default number of replicates for

one or more dilutions is incorrect, tap the correct number of replicates for each dilution.
IMPORTANT: For i‑series assays, do not order more than 10 tests for each sample that
is loaded in sample cups.
For c‑series ICT assays, do not order more than 15 tests for each sample that is loaded
in sample cups or tubes.
The total number of tests for each sample includes all assays, replicates, dilutions, and
available reagent lots for the order. Ensure that the total number of tests for a c‑series
sample does not exceed 220.
8. To save the assay option selections, tap Done.
9. Tap Patient Details.
10. In the Patient Details flyout, enter the patient demographic information.
If a draw date or a time is entered, both the draw date and the time must be entered.
11. To save the patient demographic information, tap Done.
12. To save the specimen order, tap Add Order.
13. To view the specimen order, tap Order Status.
Create a bar-coded batch specimen order

Perform this procedure to order the same tests for multiple bar-coded specimens. When running
a bar-coded batch order:
• Do not load calibrators.
• Do not leave empty spaces in a rack.
NOTE: Do not add a test to an order within a batch. If a test is added to an order that is part of
the batch order, the additional test is processed instead of the batch tests. Separately order the
additional test and load the sample after batch processing is completed.
3. Under Order Type on the Specimen tab of the Create Order screen, tap Bar-Coded Batch.
4. Under Sample Data, perform the following steps:
– Enter the starting SID.

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– Enter the ending SID.

NOTE: The ending SID must be different than the starting SID.
Batch processing begins on the sample labeled with the starting SID and continues until
the sample labeled with the ending SID is processed. All samples between the starting
SID and the ending SID, regardless of the sequence or SID, are included in the batch
process.
– Edit the default name of the batch order if necessary.
NOTE: The default batch name is BATCHXX:XX:XX, where XX:XX:XX is the time that
the batch was ordered in hours, minutes, and seconds. The batch name can have a
maximum of 20 alphanumeric characters.
– If each specimen was diluted manually, type the dilution factor in the Manual Dilution:
1: box.
NOTE: Not all assays support manual dilutions. Assays that do not support manual
dilution are displayed as unavailable when a manual dilution is selected. For dilution
5. In the Comments box, type additional information that is associated with the sample.
Comments are displayed and are printed with each sample order in the batch. Comments
can have a maximum of 50 characters.
run).
Calculated.
documentation.
by the system.

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situations occur:
10. To save the batch order, tap Add Order.
11. To view the batch order, tap Order Status.
Create a control order

Perform this procedure to create a control order manually.
3. On the Create Order screen, tap the Control tab.
4. Under Orders on the Control tab, enter the rack ID and the position number that correspond
to the sample location.
NOTE: If bar-coded samples are used or if the control product is located in the reagent
carousel, the rack ID and the position number are not required.
5. Under Control Data:
– Tap a control name in the Control Name drop-down list.
– Tap a control lot in the Control Lot drop-down list.
– Tap a control level in the Control Level drop-down list.
– If the control was diluted manually, type the dilution factor in the Manual Dilution: 1:
box.

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– To display the STAT processing code for the control, tap the Designate Sample STAT
check box.
NOTE: Controls that are designated as STAT must be priority loaded to be processed
as STAT controls.
run).
Calculated.
When a multiconstituent control vial is located on the reagent carousel, orders for assays
that are disabled for onboard use become exceptions when the orders are run.
Multiconstituent control assays that are disabled for onboard use can be ordered from vials
in a vial rack, from a sample in a sample cup, or from a bar-coded sample tube in a sample
rack that has QQQ added to the beginning of the SID.
8. For each selected assay in the Assay Options flyout, perform the following steps:
– Tap a Reagent Selection option to designate the reagent cartridge or the processing
module to run the control:
• The default is Auto. The system determines which reagent cartridge is used to
perform the test according to reagent inventory processing.
• If more than one reagent cartridge is loaded in the reagent carousel, tap Select
Cartridge, and then tap a reagent cartridge in the list.
• If more than one processing module of the same type is configured for a system,
tap Module to specify a processing module, and then tap the appropriate module
check boxes to override the system scheduler.
10. To save the control order, tap Add Order.
11. To view the control order, tap Order Status.

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Create a calibration order

Perform this procedure to create a calibration order manually.
NOTE: If the calibrators are in vials, a manual order is not required. The vials can be loaded into
a vial rack and can be presented to the reagent and sample manager (RSM) for immediate use.
3. On the Create Order screen, tap the Calibration tab.
4. Under Sample Data on the Calibration tab, enter the rack ID and the starting position.
NOTE: The rack ID and the starting position specify the use of samples that are loaded on
the RSM. However, the ID and the position are not required if the calibration uses bar-coded
samples, the calibration uses only water, or the calibrator product is loaded in the reagent
carousel.
5. Under Assays, tap an assay panel to calibrate (or tap one or more of the individual assays
to calibrate).
NOTE: If multiple c‑series assays that use a blank calibrator set are selected, a blank
calibrator is required for each calibrator set even if all the calibrator sets compose one rack.
NOTE: To filter the list of available assays, tap the option for i-series or c-series.
7. For each selected assay in the Assay Options flyout, perform the following steps:
a. In the Calibrator Lot drop-down list, tap a calibrator lot or confirm the default data.
NOTE: Only the default master lot number for the blank calibrator can be used for a
manual order.
b. If an adjust type is available, tap it to perform an adjust calibration.
c. Tap a Reagent Selection option to designate the reagent cartridge or the processing
module to perform the calibration:
• The default is Auto. The system determines which reagent cartridge is used to
perform the calibration according to calibration sample processing.
• If more than one reagent cartridge is loaded in the reagent carousel, tap Select
Cartridge, and then tap a reagent cartridge in the list.

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• If more than one processing module of the same type is configured for a system,
tap Module to specify a processing module, and then tap the appropriate module
check boxes to override the system scheduler.
9. To save the calibration order, tap Add Order.
10. To view the calibration order, tap Order Status.
Calibration sample processing, page 638
Adjustment calibration (c‑series photometric), page 781
Adjustment calibration (i‑series), page 788
Add a test to a specimen order

Perform this procedure to add a test to a specimen order.
NOTE: If a calculated assay is added and new constituent results are wanted for the calculation,
add the constituent assays in addition to the calculated assay.
Do not add a test to an order within a batch. If a test is added to an order that is part of a batch
order, the additional test is processed instead of the batch tests. Separately order the additional
test and load the sample after batch processing is completed.
3. Under Sample Data on the Specimen tab of the Create Order screen:
– Enter the SID of the original specimen.
– If the original specimen was diluted manually, type the dilution factor of the specimen in
the Manual Dilution: 1: box.
run).
Calculated.

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documentation.
by the system.
situations occur:
IMPORTANT: For i‑series assays, do not order more than 10 tests for each sample
loaded in sample cups.
For c‑series ICT assays, do not order more than 15 tests for each sample loaded in
sample cups or tubes.
8. To save the additional specimen order, tap Add Order.
9. To view the additional specimen order, tap Order Status.

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Descriptions of test statuses

Test status information is used to determine the progress of an ordered test or to manage
specimen and control results. The system tracks the test statuses for each ordered or completed
test.
The following list provides descriptions of the test statuses. The statuses are described in the
order in which they are displayed, are sorted, and are printed:
Pending The test is ordered, but the RSM bar code reader has not
scanned the corresponding sample.
Scheduled The test is ordered and the sample is scanned by the RSM
bar code reader, but the instrument has not aspirated the
sample.
Running The test is ordered, the sample is scanned, and the

instrument is processing the sample.
In Process For a calculated test, the tests that are necessary to calculate
the test result are in process.
For a batch order, the sample labeled with the starting SID of
the batch order was scanned by the RSM bar code reader,
and the batch order is in process.
Exception The test order failed and a test result was not generated.
Complete The test is completed.
Rerun List Report element descriptions, page 1683
Descriptions of processing codes

Processing code information is used to determine how samples are processed. One or more
processing codes are displayed if the codes are applicable to an ordered test or test results.
The following list provides descriptions of the processing codes. The codes are described in the
order in which they are displayed, are sorted, and are printed:
S The sample is ordered as a STAT sample.

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D The test is an automated dilution with a dilution factor that is

greater than 1, or the test is an automated dilution that is not
the first configured dilution.
M The sample is diluted manually.
R The test is a rerun.
* The test is an original result for a rerun.
B The test is part of a batch order.
C The test has a comment.
Result Details Report element descriptions, page 1685
Result List Report element descriptions, page 1689
Sample Laboratory Report element descriptions, page 1691
Delete a test from a sample order
Prerequisite The test status must be Pending or In Process.
Perform this procedure to delete a test or batch order that does not need to be processed. A
batch order that has a status of In Process completes all tests that have a status of Scheduled
or Running. No additional samples associated with the batch order are processed.
NOTE: A calculated assay that has a status of In Process cannot be deleted.
2. In the list on the Orders screen, tap one or more tests (or tap Select All).
NOTE: To filter the list, tap a tab (or tap Search).
3. Tap Delete.
4. When a confirmation message is displayed, tap OK.

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Sample Status screen

On the Sample Status screen, the operator can view the following information:
• Specimen orders, control orders, and calibration orders
• Unreleased results for specimens and controls
• Tests that are scheduled for reruns
• Test exceptions that have not been rerun, released, or deleted

• Find information about a specific test based on specified search criteria.
• Access test information.
• Add a comment to a test order.
• Transmit a result.
• Suspend the processing of a sample.
• Rerun a test.
• Print a sample status report.
Sample Status screen, Search flyout element descriptions, page 696
Sample Details screen, page 698
Sample Status screen element descriptions
All Samples tab, Specimen tab, Control tab, Calibrator tab

Displays the status of the following items:
• Specimen orders
• Control orders, exceptions, and results
• Calibrator orders and exceptions

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Sample status information can be filtered by sample type by selecting the Specimen tab,
Control tab, or Calibrator tab.
Elements
SID Name SID: Displays the sample identification, which can be one of
the following items:
specimen.
• The control name and level.
• The calibrator name and level.
The SID can be sorted alphanumerically in ascending order.

Name: Displays the name, which can be one of the following
items:
• The patient's name for specimen orders.
• The control name and level for control orders.
• The calibrator name and level for calibration orders.
The name is displayed in green text.
R/P M/P R/P: Displays the rack ID (R) and position (P) number. The
rack/position can be sorted in ascending order, first
alphanumerically by rack, and then numerically by position.
M/P: Displays the module (M) number and position (P)
number of the rack on the loading area. The M/P is displayed
in green text.
displayed as LAS/1. The M/P is blank for LAS specimens and
onboard vial racks.
Assay/Codes Assay: Displays the name of the test requested for

processing.
Codes: Displays one or more single-character codes to
indicate processing conditions.
Additional information is indicated by the following colors:
Black The test has a status of Scheduled,

Pending, Running, or In Process.

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Green The test has completed but is not

released.
Blue The test has completed and has been

released.
Red The test is an exception or has a flag.
Status/Result Status: Displays the current status (Pending, Scheduled,

Running, In Process, Exceptions, or Complete) of specimen
orders, control orders, and calibration orders or displays
specimen results and control results.
Result: Displays the following test descriptions:
• Date and time (estimated completion time when tests are
processing).
• Result value and result units.
• Date and time (time of completion).
• Message code and description (where applicable).
Additional information is indicated by the following colors:
Black The test has a status of Scheduled,

Pending, Running, or In Process.
Green The test has completed but is not

released.
Blue The test has completed and has been

released.
Red The test is an exception or has a flag.
Interpretation Displays the interpretation of the result value obtained.
Flags Displays the flags associated with specimen results and

quality control results.
Function buttons

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current screen.
Suspend Displays a message requesting confirmation to suspend

processing on the selected module or section to access a
sample.
Rerun Displays the Rerun Options flyout.
Release Releases the selected test results or exceptions. Test results

remain on the Sample Status screen until all results for the
specimen or control are released. Test exceptions that have
not been rerun or released for transmission remain on the
screen. Rerun or released test exceptions remain on the
Sample Status screen until all results are transmitted.
Sample Status screen, Search flyout element descriptions

In the Search flyout of the Sample Status screen, the operator can enter specific data that is
Elements
Find Sample Used to select a location in the database to find the sample.
The Search flyout has two options:
Sample Status Used to search for the sample on the

Sample Status screen.

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System Wide Used to search for the sample on all

data screens.
Module Displays a drop-down list that is used to search for a module

by the module number.
RSM Position Used to search by a position number on the reagent and

sample manager.
SID Used to search by the bar code number or identification

assigned to the sample.
PID Used to search by the patient identification number.
Last Name Used to search by the patient's last name.
First Name Used to search by the patient's first name.
Rack Used to search by the rack ID.

position.
Start Date Used to enter a search start date.
End Date Used to enter a search end date.
Function buttons




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Sample Details screen

On the Sample Details screen, the operator can view the following information:
• Details for specimen results, control results, or exceptions
• Details for a specimen test order, a control test order, or a calibrator test order
The operator can add a comment to an order, a result, or an exception.
Sample Details (Specimen, Control, and Calibrator) screen element descriptions, page 698
Add a comment to a result or an exception, page 702
Sample Details (Specimen, Control, and Calibrator) screen element descriptions

The Sample Details screen displays the sample details for specimens, controls, and calibrators.


system when the test was processed.
Sample Type Displays the sample type for the test:

• Specimen
• Control
• Calibrator
loading area.
completed.

only for specimens.

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only for specimens.
Name Displays the name of the patient. This element is displayed

only for specimens.
Transmission Status Displays the status of the test transmission to the host. This
element is not displayed for calibrators.
Released By Displays the identification of the operator logged onto the

system when the test was released. This element is not
displayed for calibrators.
Control Information area

This area is displayed only for controls.
Control Lot Exp. Displays the expiration date of the control lot.
Calibrator Information area

This area is displayed only for calibrators.
Calibrator Name Displays the name of the calibrator.
Calibrator Lot Displays the lot number of the calibrator.
Calibration Method Displays the data reduction method used for the assay.
Calibrator Level Displays the name of the calibrator level.
Calibrator Lot Exp. Displays the expiration date of the calibrator lot.
Calibration Type Displays the type of assay calibration performed.

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Result Displays the value, unit, and (where applicable) interpretation

of the result.
Absorbance/mV Displays the response value used to calculate the result:

(c‑series)
• Millivolt (only for ICT)
• Absorbance (only for photometric assays)
NOTE: This element is not displayed for sample interference

index assays.
RLU (i‑series) Displays the response value in relative light units that is used
to calculate the result.
Flag Displays the flags associated with specimen results and

Normal Range Displays the normal or therapeutic range for the assay. This
Control Range Displays the control range configured for the assay. If a
control range is not configured, the control range that is
displayed is calculated based on the configured expected
mean and expected standard deviation (1 SD). This element is
Cuvette (c‑series) Displays the number of the cuvette used to process the test.
This element is not displayed for calibrators.
Module/SN Displays the serial number of the module.
Message Displays the message code number and description.

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Expiration
Calibration Displays the date and time of the reagent calibration.

Archive Status Displays the archive status of the test: Archived or Not
Archived. This element is not displayed for calibrators.
Archive Date and Time Displays the date and time that the test was archived. This
test.
Function buttons



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Add a comment to a result or an exception

Perform this procedure to add a comment to a result or an exception. This procedure can be
performed from the Sample Status screen or the Results screen.
1. To find test results that require a comment, perform the steps from one of the following
screens:
Sample Status screen:
– On the menu bar, tap Sample Status.
– Under SID Name on the All Samples tab, tap a sample.
NOTE: To filter the list, tap the Specimen tab or the Control tab (or tap Search).
Results screen:
– On the menu bar, tap Results.
The default is the Unreleased tab.
– To add a comment to a released specimen, a released control, or an exception, tap the
appropriate tab.
NOTE: To filter the list, tap Search.
2. In the list, tap one or more results or exceptions (or tap Select All).
3. Tap Details.
4. In the Comment box, type additional information that is associated with the result or
exception.
Comments are displayed and are printed with the result or exception. In addition, comments
for samples and tests are displayed if comments were entered.
5. If more than one result or exception was selected, tap Next or Previous to display each
order, and then type a comment for each order.
6. To save the comments, tap Done.
Result Details screen, page 715

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Rerun a test or an exception for a specimen or control

Perform this procedure to rerun a specimen test, a control test, or an exception. If additional
tests are required, a new order must be created. This procedure can be performed from the
Sample Status screen or the Results screen.
NOTE: Only exceptions with a status of Blank can be rerun.
1. Retrieve the original sample and verify the following conditions:

– The volume is adequate.
– The sample integrity is acceptable.
2. Return the sample to the reagent and sample manager.
3. To find the test result to rerun, perform the steps from one of the following screens:
– Under SID Name on the All Samples tab, tap the sample.
Results screen:
– To rerun an exception, tap the Exception tab.
4. In the list, tap one or more tests to rerun (or tap Select All).
NOTE: To rerun a calculated assay, perform one of the following steps:
documentation.
by the system.

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5. Tap Rerun.
6. For each selected assay in the Rerun Options flyout, perform the following steps:
– Enter the rack ID and the position number.
NOTE: When bar-coded samples are used, the rack ID and the position number are not
required.
7. To save the rerun option selections, tap Done.
The rerun tests that are scheduled can be viewed on the Sample Status screen or the
Orders screen.
Release a specimen result or a control result

Perform this procedure to release manually the specimen results or control results that have
been reviewed. This procedure can be performed from the Sample Status screen or the Results
screen.
1. To find test results to release, perform the steps from one of the following screens:
– Under SID Name on the All Samples tab, tap a sample.
Results screen:

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2. In the list, tap one or more tests to release (or tap Select All).
3. Tap Release.

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Results screen Section 5
Results screen
On the Results screen, the operator can view the following information:
• Specimen and control results
• Specimen and control exceptions

• Find information about a specific test based on specified search criteria.
• Access result information.
• Release or delete a result.
• Rerun a test.
Results screen, Exception tab element descriptions, page 711
Results screen, Search flyout element descriptions, page 713
Rerun Options (Specimen Order) flyout element descriptions, page 719
Rerun Options (Control Order) flyout element descriptions, page 720
Descriptions of transmission statuses, page 725
View the reaction graph and absorbance data for a result (c‑series), page 726
Delete a sample result or an exception, page 727
Transmit a result or an exception to the host, page 727

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Section 5 Results screen
Results screen, Unreleased tab element descriptions

The Unreleased tab displays completed specimen and control results that have not been
released. The Unreleased tab is not displayed if patient and control release modes are set to
automatic or automatic with exceptions.
Elements
Module ID Displays the module number of the module used to process

the test. The module number for specimen results of
calculated assays is 6 (system control module). The module
number for control results of calculated assays is the
processing module used to produce the constituent results.
R/P Displays the rack ID (R) and position (P) number.

displayed as LAS/1.
SID Displays the sample identification, which can be one of the

following items:
specimen.
Name Displays the name, which can be one of the following items:
• The name of the specimen.
Assay Displays the name of the test.
Result Displays the value and unit of the test result.

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Interpretation Displays the interpretation of the test result.

quality control results. All results with flags are displayed in
red text.
Code Displays one or more single-character codes to indicate

processing conditions.
Time Displays the date and time that the test completed processing.
Function buttons
current screen.
Release Moves the selected test results to the Specimen tab or the
Control tab.

selected items.
Results screen, Specimen tab element descriptions

The Specimen tab displays released specimen results.

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Elements
Module ID Displays the number of the module used to process the test.
The module number for results of calculated assays is 6 (the
system control module).

displayed as LAS/1.

specimen.
Name Displays the name of the specimen.
Interpretation Displays the interpretation of the test result.
Flag Displays the flags associated with the specimen results.
Code Displays one or more single-character codes to indicate

processing conditions.
Function buttons
Archive Displays the Archive flyout.
current screen.
Transmit Sends selected test results to the host computer.

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selected items.
Results screen, Control tab element descriptions

The Control tab displays released control results.
Elements
The module number for results of calculated assays is the
processing module used to produce the constituent results.

displayed as LAS/1.

control.
Control Displays the name of the control that was processed.
Lot Displays the lot number of the control that was processed.
Level Displays the level of the control that was processed.
Flag Displays the flags associated with the quality control results.

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Function buttons
Archive Displays the Archive flyout.
current screen.

selected items.
Results screen, Exception tab element descriptions

The Exception tab displays rerun and unreleased test exceptions and test exceptions that have
been released manually or automatically for transmission. A test exception remains on the
Exception tab until the exception is deleted by an operator or is deleted automatically after
24 hours based on the completion time of the exception.
Elements

displayed as LAS/1.

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specimen, control, or calibrator test order.
Name Displays the name of the specimen, control, or calibrator.
Test Type Displays the type of sample that was ordered: Specimen,
Control, or Calibrator.
Status Displays the status of the exception, which can be one of the
following statuses:
<Blank> Exceptions have not been rerun or

released.
Rerun Exceptions have been rerun, but they

have not been released.
Released Exceptions have been released

manually or automatically for
transmission to a host computer.
Message Code Displays the numeric message code for the exception and the
message text that describes the error.
Function buttons
current screen.

selected items.

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Results screen, Search flyout element descriptions

In the Search flyout of the Results screen, the operator can enter specific data that is used to
filter the data on the screen.
Elements
The module number for the specimen results of calculated
assays is 6 (the system control module). The module number
for control results of calculated assays is the processing
module used to produce the constituent results.
Name Displays a text box that is used to search by the name, which
can be one of the following items:
• The name of the specimen.
Control Lot Displays a text box that is used to search by the control lot.
Control Level Displays a text box that is used to search by the control level.
SID Displays a text box that is used to search by the bar code
number or identification assigned to the sample.
PID Displays a text box that is used to search by the patient
Rack Displays a text box that is used to search by the rack


position.
RSM Position Displays a drop-down list that is used to search by a position


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Reagent Lot Displays a text box that is used to search by the reagent lot
number.

Start Time Displays a spin box that is used to enter a search start time.
End Time Displays a spin box that is used to enter a search end time.
Operator Displays a text box that is used to search by the operator ID.
Results with Displays check boxes that are used to select results that have
one of the following associated items:
• Flags
• Interpretations
Test Type Displays check boxes that are used to select results for a
specific sample type. This element is displayed only for
unreleased results. The Search flyout has two test types:
• Specimen
• Control
Status Displays check boxes that are used to select result statuses.
This element is not displayed for unreleased results. The
Search flyout has six status types:

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• Pending Transmission
• Pending Collation
• Transmitted
• Not Transmitted
• Archived
• Not Archived
Function buttons



Result Details screen

On the Result Details screen, the operator can view the following information:
• Details for specimen results, control results, or exceptions
• Reaction graphs only for c‑series
The operator can add a comment to a result or an exception.
Result Details (Specimen and Control) screen element descriptions, page 715
Result Details (Specimen and Control) screen element descriptions

The Result Details screen displays the result details for specimens and controls.

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system when the test was processed.
Sample Type Displays one of the following sample types for the test:
• Specimen
• Control
loading area.
completed.

only for specimens.

only for specimens.
Name Displays the name of the patient. This element is displayed

only for specimens.
Transmission Status Displays the status of the test transmission to the host.
Released By Displays the identification of the operator logged onto the

system when the test was released.

This area is displayed only for controls.

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Result Displays the value, unit, and (where applicable) interpretation

of the result.
Absorbance/mV Displays the response value used to calculate the result:

(c‑series)
• Millivolt (only for ICT)
• Absorbance (only for photometric assays)
NOTE: This element is not displayed for sample interference

index assays.
RLU (i‑series) Displays the response value in relative light units that is used
to calculate the result.

Normal Range Displays the normal or therapeutic range for the assay. This
Control Range Displays the control range configured for the assay. If a
control range is not configured, the control range that is
displayed is calculated based on the configured expected
mean and expected standard deviation (1 SD). This element is

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Cuvette (c‑series) Displays the number of the cuvette used to process the test.
This element is not displayed for calibrators.
Module/SN Displays the serial number of the module.

Expiration

Archive Status Displays the archive status of the test: Archived or Not
Archived. This element is not displayed for calibrators.
Archive Date and Time Displays the date and time that the test was archived. This
test.

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Function buttons


Rerun Options (Specimen Order) flyout element descriptions

In the Rerun Options flyout, the operator can order a rerun for a specimen test.
Elements
Sample ID Displays the bar code number or identification assigned to the

specimen.
Rack Displays the rack ID if it was entered in the original order.
Position Displays the rack position if a rack ID was entered in the

original order.

specimen.
Assay Displays the name of the assay ordered.

Name Displays the specimen name.
Module Selection Displays the following options:

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processing module.
Module Displays options that are used to select

a processing module if more than one
module of the same type is configured
for a system.
Dilution Protocols/ Used to select the correct number of replicates for each
Number of Replicates dilution protocol.
Function buttons



Rerun Options (Control Order) flyout element descriptions

In the Rerun Options flyout, the operator can order a rerun on a control test.
Elements
Sample ID Displays the control lot number and control level number. Bar-
coded controls include a serial number when quality controls
are run in a vial rack. Bar-coded controls include the prefix
QQQ followed by the control lot number and level when the
controls are run in a sample rack.
Rack Displays the rack ID if it was entered in the original order.
Position Displays the rack position if a rack ID was entered in the

original order.

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Control Name Displays the control name.
Assay Displays the name of the assay ordered.
Control Level Displays the control level.
Control Lot Displays the control lot.
Reagent Selection Displays the following options:

reagent cartridge.

Select Cartridge is selected, the
following information is available:
Dilution Protocols/ Used to select the correct number of replicates for each
Number of Replicates dilution protocol.
Function buttons



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Descriptions of specimen result flags

Specimen result flag information is used to provide additional information about a result and to
indicate that the result may need to be reviewed. When a specimen result has a flag, the
information is displayed in red text on the Results screen. One or more result flags are displayed
if they are applicable to a specimen result.
The following list provides descriptions of the specimen result flags. The flags are described in
the order in which they are sorted:
EXP* The result was measured by using one of the following

expired items:
• Reagent
• Supply
• Onboard solution
EXPC* The result was calculated by using an expired calibration or

expired calibrators.
A#1* (c‑series) The result was calculated by using the only reading, of all the
readings in the main read time, that has measured
absorbance within the defined absorbance range. This
condition can occur when the result concentration is high or
the sample is lipemic.
A#2* (c‑series) The result was calculated by using the only two readings, of
all the readings in the main or flex read time, that have
measured absorbance within the defined absorbance range.
This condition can occur when the result concentration is high
or the sample is lipemic.
CNTL* The result was calculated after the quality control failed.
The flag is displayed on subsequent results until the failed
quality control (QC) result is rerun for the same control name
and control level and the result is within acceptable limits.

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When the control material cannot be repeated to obtain an

acceptable value, the procedure to clear a control failure
must be performed.
When out-of-range QC results are deleted or the assay is
uninstalled, the CNTL flag is not removed from patient results.
NOTE: Only Westgard rules that are configured as a failure
produce a CNTL flag for a patient result.
< or > The result falls outside the dynamic or linear range.
NOTE: For c‑series assays, the displayed value is the result
of an adjustment by the sample dilution factor. Additionally,
the displayed > value reflects an adjustment by the entered
correlation factor and intercept for assays that use nonlinear
calibration methods when the sample absorbance exceeds
the highest calibrator absorbance.
FLEX* (c‑series) The result was calculated by using the reading data that was
measured during the flex read time.
LL or HH The result falls outside the defined extreme range.

NOTE: The result is rounded to the reporting number of
decimals for an assay and then is compared against the
range.
PSHH* (c‑series ICT The result may be affected by the ICT sample that was
assays) measured immediately before this sample. The sample must
be rerun to verify that no affects have occurred.
LOW or HIGH The result falls outside the defined normal range.
NOTE: The result is rounded to the reporting number of
decimals for an assay and then is compared against the
range.
CORR* The result was produced by using a correlation version of the

assay.
* These flags are carried over from a constituent assay result to a calculated assay result.

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Clear a control failure, page 748
A#1 result flag (c‑series), page 1425
FLEX result flag (c‑series), page 1434
PSHH result flag (c‑series), page 1434
Descriptions of quality control result flags

Quality control (QC) result flag information is used to provide additional information about a
result and to indicate that the result may need to be reviewed. When a QC result has a flag, the
information is displayed in red text on the Results screen. One or more result flags are
displayed if they are applicable to a QC result.
The following list provides descriptions of the QC result flags. The flags are described in the
CNTL The QC result falls outside the minimum and maximum

control level range.
Westgard rule The QC result failed a Westgard rule.
EXP* The result was measured by using one of the following

expired items:
• Reagent
• Supply
• Onboard solution
• Control material
• ICT module (only for c‑series)
EXPC* The result was calculated by using an expired calibration or

expired calibrators.
A#1* (c‑series) The result was calculated by using the only reading, of all the
readings in the main read time, that has measured
absorbance within the defined absorbance range. This
condition can occur when the result concentration is high or
the sample is lipemic.

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A#2* (c‑series) The result was calculated by using the only two readings, of
all the readings in the main or flex read time, that have
measured absorbance within the defined absorbance range.
This condition can occur when the result concentration is high
or the sample is lipemic.
< or > The result falls outside the dynamic or linear range.
NOTE: For c‑series assays, the displayed value is the result
of an adjustment by the sample dilution factor. Additionally,
the displayed > value reflects an adjustment by the entered
correlation factor and intercept for assays that use nonlinear
calibration methods when the sample absorbance exceeds
the highest calibrator absorbance.
FLEX* (c‑series) The result was calculated by using the reading data that was
measured during the flex read time.
PSHH* (c‑series ICT The result may be affected by the ICT sample that was
assays) measured immediately before this sample. The sample must
be rerun to verify that no affects have occurred.
CORR* The result was produced by using a correlation version of the

assay.
* These flags are carried over from a constituent assay result to a calculated assay result.
Descriptions of transmission statuses

Transmission status information is used to determine the progress of a result transmission to the
host. The transmission status is displayed on the Result Details flyout.

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The following list provides descriptions of the transmission statuses:
Transmitted The test is completed and has been successfully transmitted

to the host.
Pending Transmission The test is completed, but the test is waiting to be transmitted
to the host.
Pending Collation The test is completed, but the system is waiting for one of the
following actions to occur before the system transmits to the
host:
• All tests that are associated with the SID are completed.
• All tests that are associated with the SID on a specific
processing module are completed.
<Blank> The test is completed, but the test is not transmitted, is not
pending transmission, or is not pending collation.
View the reaction graph and absorbance data for a result (c‑series)
Perform this procedure to view the reaction graphs and absorbance data for the released and
unreleased specimen and control results for c‑series.
1. On the menu bar, tap Results.
The Unreleased tab on the Results screen is the default.
2. To view the reaction graph or absorbance data for a released specimen or a released
control, tap the appropriate tab.
NOTE: To filter the list of results, tap Search.
3. In the list on the tab, tap one or more results (or tap Select All).
4. Tap Details.
5. On the Result Details screen, tap Graph View to display the reaction graph and absorbance
data for the first result.
6. To edit the absorbance scale of the reaction graph, type the values in the Y Axis Scale
boxes, and then tap Rescale.
NOTE: Although an updated view of the reaction graph is displayed, edits to the Y axis scale
are not saved.

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7. If more than one result was selected, tap Next or Previous to display the reaction graph
and absorbance data for each result.
8. To return to the reagent and additional information on the Result Details screen, tap Details
View.
9. To return to the Results screen, tap Done.
page 1543
Delete a sample result or an exception

Perform this procedure to complete the following tasks:
• Delete a released or an unreleased sample result that is not needed on the system.
• Delete a control result that is not needed on the system.
• Delete an exception that is not needed for troubleshooting.

2. To delete released specimens, released controls, or exceptions, tap the appropriate tab.
3. In the list on the tab, tap one or more results or exceptions (or tap Select All).
4. Tap Delete.
Transmit a result or an exception to the host

Perform this procedure to transmit a released specimen result, a released control result, or an
exception to the host.
2. To transmit released specimens, released controls, or exceptions, tap the appropriate tab.

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3. In the list on the tab, tap one or more results or exceptions (or tap Select All).
NOTE: No more than 10,000 records can be transmitted (pending transmission and new
selections) at one time.
4. Tap Transmit.

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Section 5 Quality control analysis
Quality control analysis

Quality control analysis is the process by which quality control (QC) data is monitored. QC data
includes both unreleased and released control results. The Alinity ci‑series monitors QC data
with Levey-Jennings graphs, Westgard rules, control range tracking, and QC data summaries.
To help ensure quality results and maintain optimal system performance, comply with the
following requirements:
• Carefully follow all directions in the operations manual and the reagent manufacturer's
assay documentation.
• Do not use expired or contaminated consumables.
• Perform maintenance procedures and calibration procedures as recommended.
IMPORTANT: Quality control issues must be evaluated and resolved before specimens are
tested.
The system evaluates quality control (QC) results by assay for each control lot. If reagents are
configured to be disabled when a control failure occurs, and a control failure occurs for one or
more reagent cartridges, the failure prevents the use of one or more of the cartridges on the
module on which the failure occurred.
A system configuration parameter determines whether controls are run for an assay for each
reagent lot or each reagent cartridge. If quality control is run for each reagent cartridge and any
control level fails, the individual reagent cartridge is disabled. If quality control is run for each
reagent lot and a tested control level fails, all reagent cartridges for that lot are disabled,
including any cartridges that are subsequently loaded on the system. The system enables the
reagent cartridge or the reagent lot after the failed QC result is rerun and the result is within
acceptable limits.
Levey-Jennings (Graph) screen, page 733
Quality Control Summary screen, page 740
Westgard rule application

When Westgard rules are configured, the Alinity ci‑series compares a control result at
completion against the expected mean and standard deviation for the control level. Previous
results, released and unreleased, for the same assay and module are considered in the analysis.
Control results that are marked as excluded are not considered.

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Quality control analysis Section 5
Westgard rule descriptions, page 730

Configure Westgard rules, page 366
Westgard rule descriptions

Control results for an assay are evaluated at completion against all Westgard rules that are
enabled for the assay. Westgard rules that are configured as a failure are evaluated first, and
then the rules that are configured as a warning are evaluated.
NOTE: When one-material (1M) rules are evaluated, previous control results that have the same
control name, control level name, and control lot number are considered.
When across-materials (xM) rules are evaluated, previous control results that have the same
control name, the same control lot number, and different control level names are considered.
If a control result meets the failure criteria for only one Westgard rule, the result is flagged with
the corresponding rule flag. If the failure criteria for more than one Westgard rule is met, only
one rule flag is applied to the control result according to the following order:
1. 1-3s
2. 2-2s 1R 1M
3. 2-2s 1R xM
4. 2-2s xR 1M
5. R-4s
6. 4-1s 1m
7. 4-1s xM
8. 10-x 1M
9. 10-x xM
10. 1-2s
When a failure is identified, no further evaluation occurs. A CNTL flag is applied to each patient
result associated with an assay that has a control failure. The CNTL flag is not applied to patient
results for control failures that are configured as a warning.
The following list provides descriptions of the Westgard rules:
1-2s Control rule to test whether a control measurement exceeds

the control limits of Mean (x) + 2 standard deviation (SD) or x
- 2 SD.
1-3s Control rule to test whether a control measurement exceeds

the control limits of x + 3 SD or x - 3 SD.

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2-2s 1R 1M Control rule to test whether two consecutive control

measurements for the same control material within the same
run exceed the same control limit of either x + 2 SD or x -
2 SD. Both control results must fall on the same side of the
mean.
2-2s 1R xM Control rule to test whether two consecutive control

measurements across control materials within the same run
exceed the same control limit of either x + 2 SD or x - 2 SD.
Both control results must fall on the same side of the mean.
The two control results must have different control level
names.
2-2s xR 1M Control rule to test whether two consecutive control

measurements for the same control material across two
different runs exceed the same control limit of either x + 2 SD
or x - 2 SD. Both control results must fall on the same side of
the mean. The previous consecutive control result can be
obtained during any previous run.
R-4s Control rule to test whether the range, or difference, between

control measurements that are run within 30 minutes of each
other exceeds 4 SD. The two control results must have the
same control name, can have the same or different control
level names, and do not need to be consecutive. The current
control result is compared against each control result, which
is older than the current result by 30 minutes or less. Each
result must be greater than 2 SD, but in opposite directions.
4-1s 1M Control rule to test whether four consecutive control

measurements for the same control material exceed the same
control limit of either x + 1 SD or x - 1 SD. All four control
results must fall on the same side of the mean. The previous
control results can be obtained during any run.
4-1s xM Control rule to test whether four consecutive control

measurements across control materials exceed the same
control limit of either x + 1 SD or x - 1 SD. All four control
results must fall on the same side of the mean. The previous
control results can be obtained during any run. For this rule,
both control results with the same or different control level
names are considered.
10-x 1M Control rule to test whether 10 consecutive control

measurements for the same control material fall on the same
side of the mean. If a control result falls on the mean, the rule

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does not fail. The previous control results can be obtained

during any run.
10-x xM Control rule to test whether 10 consecutive control

measurements across control materials fall on the same side
of the mean. If a control result falls on the mean, the rule
does not fail. The previous control results can be obtained
during any run. For this rule, both control results with the
same or different control level names are considered.
Westgard rule run descriptions

Westgard rule run descriptions identify the options to define quality control run intervals on the
Alinity ci‑series. A time-based quality control run is configured by using a start time and a time
interval to define the number of hours in the run. The run period is used to evaluate the following
Westgard rules:
• 2-2s 1R 1M
• 2-2s 1R xM
• 2-2s xR 1M
• 4-1s 1M
• 4-1s xM
The following list provides Westgard rule run descriptions:
Start time for the first The quality control shift start time is defined for each c‑series
run processing module and each i‑series processing module by
configuring the Shift Start Time parameter on the Modules
screen. The system creates quality control orders at the
configured time for those controls for which the Automated
and Use Module Shift Time options are enabled.
The quality control shift start time is defined for a control by
configuring the Start Time parameter in the Control
Configuration area of the Control Create/Edit screen. The
system creates quality control orders at the configured time
for the control when the Automated option is enabled.
Run period length On a control-level basis, the Time Interval (Minutes)

parameter defines the time interval in minutes after the shift
start time for additional control orders to be created. If the

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configured time interval cannot be divided equally into timed

run periods in the 24-hour day, the last run is composed of
the remaining hours.
If the assay time interval is configured, the configured assay
time interval supersedes the configured control level time
interval if both intervals are defined for the same quality
control lot number.
Configure c‑series module settings, page 189
Configure i‑series module settings, page 190
Levey-Jennings (Graph) screen

On the Levey-Jennings (Graph) screen, the operator can perform the following functions:
• View a maximum of six Levey-Jennings graphs and the statistical data for the same control
name and lot number for a specific processing module.
• View the Levey-Jennings graphs for the same assay, control name, and lot number for a
maximum of four processing modules of the same type in a multimodule system.
• Change the criteria for a Levey-Jennings graph and its data.
• Include or exclude points from a Levey-Jennings graph.
• Print a Levey-Jennings report.
• Recalculate the Westgard analysis for a Levey-Jennings point.
• View the details of a selected Levey-Jennings point.
• Add a comment to a Levey-Jennings point.
Levey-Jennings (Graph) screen element descriptions, page 733
Point Details screen element descriptions, page 736
Display the value for a Levey-Jennings point, page 738
Exclude or include a Levey-Jennings point, page 738
View the details for a Levey-Jennings point, page 739
Add a comment to a Levey-Jennings point, page 739
Levey-Jennings (Graph) screen element descriptions

The Levey-Jennings (Graph) screen displays the quality control graphs for the selected assay.

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Elements
Assay Displays the name of the assay selected on the Quality

Control Summary screen.
Control Displays the name of the control.
Lot Number Displays the lot number of the control.
Exp. Date Displays the expiration date of the control lot.
Comparison Type Displays the source of the mean and standard deviation (SD)
used to compare to the expected mean and SD.
The following comparison types are available in the drop-
down list:
• None
• Manufacturer
• Module Cumulative
• System Cumulative
Selected Data Range Displays control data for the date range selected on the
Quality Control Summary screen.
Displayed Data Range Displays the date range of the displayed points. As the graph
is navigated, the displayed data range changes to reflect the
points being viewed.
Level Displays the name of the control level.
Module Displays the number of the module used to process one or

more controls.
Mean Displays the expected mean value as configured.
SD Displays the expected SD value as configured.
Control Range Displays the expected control range as configured.
Comparison Mean Displays the mean used to compare to the expected control
mean. Information that is displayed is determined by the
comparison type selected.

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Comparison SD Displays the SD used to compare to the expected control SD.

Information that is displayed is determined by the comparison
type selected.
N Displays the number of control points covered by the selected

date range.
Graph elements
Mean Represented by the center line of the graph and indicates the
expected control mean.
+1 SD and -1 SD Represented by the first line above and below the mean
(green area).
+2 SD and -2 SD Represented by the second line above and below the mean
(yellow area).
+3 SD and -3 SD Represented by the third line above and below the mean (red
area).
Points Control results that fall within the defined control range and
do not fail configured Westgard rules are represented by a
black dot and are graphed in the order of completion.
Control points that caused a warning condition based on the
Westgard analysis are represented by a yellow dot.
Control points that failed Westgard analysis are represented
by a red dot.
Control points beyond +/- 3 SD are shown as a horizontal line.
Excluded control points are represented by a white circle with
a black dot.
Function buttons
QC Summary Navigates to the Quality Control Summary screen.
Point Details Navigates to the Point Details screen.

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Point Details screen element descriptions

The Point Details screen displays the details for the selected control value.

system when the control result was generated or released.
Time of Completion Displays the date and time that the control result was
generated.
Point Information area
Point Value Displays the control result.
Flags Displays the flags associated with the quality control result.
Codes Displays the processing codes associated with the control

result.
Point SD Displays the standard deviation of the control result.
Mean Displays the expected mean value as configured.
1 SD Displays the expected standard deviation value as configured.

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Expiration
Module/Position Displays the module number and the position number in the
reagent carousel where the cartridge is loaded. Dashes are
displayed for the module and position number when the
cartridge is not loaded on the system.
Include or Exclude Used to exclude a quality control result or to include a

Point previously excluded result.
Perform Westgard Re- Used to recalculate the Westgard analysis.

evaluation
System Comment Displays the system comments.
Comment Displays a text box that is used to enter a reason for the
inclusion or exclusion of the control point.
Function buttons



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Display the value for a Levey-Jennings point

Perform this procedure to display the result value and the date and time for a specific point on
the Levey-Jennings (Graph) screen.
1. Create a Levey-Jennings graph.
2. Tap a point on the Levey-Jennings graph.
3. Tap Point Details.
4. On the Point Details screen, view the point value and the date and time that the control was
run.
5. To return to the Levey-Jennings (Graph) screen, tap Done.
6. To display the value for another Levey-Jennings point, repeat steps 2, page 738 through 5,
page 738.
7. To return to the Quality Control Summary screen, tap QC Summary.
Create a Levey-Jennings graph, page 747
Exclude or include a Levey-Jennings point

Perform this procedure to exclude a point, or to include a previously excluded point, from the
quality control statistics.
4. On the Point Details screen, perform one of the following steps:
– Tap Include to include a previously excluded point.
– Tap Exclude to exclude a point.
NOTE: The system software automatically excludes a control result that exceeds a value
that is six times the expected standard deviation (SD).
5. In the Comment box, type a reason for the inclusion or exclusion of the point.
NOTE: The comment replaces a previously entered comment.
After a point is included or excluded, the system software recalculates the cumulative mean,
SD, and sample size for the quality control (QC) data. Excluded points are not included in
the recalculation.
6. To recalculate the Westgard analysis, tap the Perform Westgard Re-evaluation check box.
NOTE: The system software does not recalculate the Westgard data if more than 5000 QC
data points are pending an adjustment.

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7. To save the edits and return to the Levey-Jennings (Graph) screen, tap Done.
8. To include or exclude another Levey-Jennings point, repeat steps 2, page 738 through 7,
page 739.
View the details for a Levey-Jennings point

Perform this procedure to view the details for a specific point on a Levey-Jennings graph.
2. Tap a point on the Levey-Jennings graph to display the point value and the date and time
that the control was run.
3. Tap Point Details to display all data that is available for the selected point.
4. On the Point Details screen, view the details for the selected point.
5. To return to the Levey-Jennings (Graph) screen, tap Done.
6. To view the details for another Levey-Jennings point, repeat steps 2, page 739 through 5,
page 739.
Add a comment to a Levey-Jennings point

Perform this procedure to add a comment to a point on a Levey-Jennings graph.
4. In the Comment box on the Point Details screen, type a comment.
NOTE: The new comment replaces any existing comment for the point.
5. To save the comment and return to the Levey-Jennings (Graph) screen, tap Done.
6. To add a comment to another Levey-Jennings point, repeat steps 2, page 739 through 5,
page 739.

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Quality Control Summary screen

On the Quality Control Summary screen, the operator can view the statistical data for all assay
control levels.
NOTE: Statistical calculations are performed for all released results, including quality control
results for a specific processing module, assay, control name, lot number, and level
combination.
The quality control summary data is not displayed if the values for expected mean and expected
standard deviation (1 SD) are not defined for the control.
• Find information about a specific control based on specified search criteria.
• Access quality control information.
• Create a Levey-Jennings graph for a selected assay control level.
• Print the QC Analysis Report and the QC Summary Report.
The system administrator can clear a control failure for an assay for a specific control, lot
number, and level.
Quality Control Summary screen element descriptions, page 740
Quality Control Summary screen, Search flyout element descriptions, page 742
Control Summary Details screen, page 743
Clear Control Failure flyout element descriptions, page 746
Clear a control failure, page 748
View the quality control (QC) summary data, page 749
View the control summary details, page 750
Quality Control Summary screen element descriptions
Elements
Module Used to select all modules or individual modules to view

information.

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Date Range Used to enter a date range to search or displays the control
summary information for the selected date range.
Update button Searches and displays data for the entered date range when
a new date is selected.
Module Displays the module number.
Assay Displays the name of the assay.
Lot Number Displays the lot number for the control.
Level Displays the level for the control that was processed.
N Displays the number of control points that are available for

the same level, lot, assay, and module used in the calculation.
Flagged Displays the number of flagged control results.
Actual Mean Displays the mean calculated for the level, lot, and assay for
a processing module and the specified date range.
Actual SD Displays the standard deviation calculated for the level, lot,
and assay for a processing module and the specified date
range.
%CV Displays the percent coefficient of variation calculated for the

level, lot, and assay for a processing module and the
specified date range.
Expected Mean Displays the expected mean configured for the control level.
Expected SD Displays the expected standard deviation configured for the

control level.
Expected Range Displays the expected control range configured for the control
level.
Function buttons

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current screen.
Graph Displays the Levey-Jennings (Graph) screen for the selected

assay.

Quality Control Summary screen, Search flyout element descriptions

In the Search flyout of the Quality Control Summary screen, the operator can enter specific data
that is used to filter the data on the screen.
Elements
Control Name Displays a text box that is used to search by the control
name.
Lot Displays a text box that is used to search by the control lot
number.
Level Displays a text box that is used to search by the level of the
control that was processed.
SID Displays a text box that is used to search by the sample

identification (SID) of the control. The control SID is the
control lot number and control level number. Bar-coded
controls include a serial number when quality controls are run
in a vial rack. Bar-coded controls include the prefix QQQ
followed by the control lot number and level when the controls
are run in a sample rack.

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Results with Flags Displays a check box that is used to search for control results
that have flags.
Function buttons



Control Summary Details screen

On the Control Summary Details screen, the operator can view the following statistical data for a
selected control lot number and level:
• Expected mean and expected standard deviation (SD)
• Manufacturer mean and SD
• Quality control data for the selected processing module and the defined date range
• System control data that represents the data for all processing modules of the same type in
a multimodule system for the defined date range
• Module cumulative data that represents all the data for the selected processing module
• System cumulative data that represents the data for all processing modules of the same
type in a multimodule system
Control Summary Details screen element descriptions, page 743
Control Summary Details screen element descriptions

The Control Summary Details screen displays the details for an assay control level.

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Date Range Displays the default date range or the date range entered on
the Quality Control Summary screen.
Module/Serial No. Displays the module number and serial number of the module
used to process the control.
NOTE: The processing module used to produce the
constituent results displays the quality control summary data
for calculated assays.
Expected area
Mean Displays the configured mean for the control.
SD Displays the configured standard deviation (SD) for the

control.
Range Displays the configured range for the control.
Manufacturer area
Mean Displays the configured manufacturer's mean for the control.
SD Displays the configured manufacturer's SD for the control.
Module Date Range area
Mean Displays the calculated mean for the selected module and
date range.
NOTE: The statistical calculations in the Module Date Range
area are based on all released results. These calculations
also include the results in the date range for a specific
combination of module, assay, control name, control lot
number, and control level.
SD Displays the calculated SD for the selected module and date

range.

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% CV Displays the calculated percent coefficient of variation (%CV)

for the selected module and date range.
N Displays the number of data points in the control file for the
selected module and date range.
Range Displays the range of values in the control file for the selected
module and date range.
System Date Range area
Mean Displays the calculated mean for the data in the date range
for all modules of the same type in a multimodule system.
SD Displays the calculated SD for the data in the date range for
all modules of the same type in a multimodule system.
% CV Displays the calculated %CV for the data in the date range for
all modules of the same type in a multimodule system.
N Displays the number of data points in the control file in the

date range for all modules of the same type in a multimodule
system.
Range Displays the range of values in the control file in the date
range for all modules of the same type in a multimodule
system.
Module Cumulative area
Mean Displays the cumulative calculated mean for the selected

module.
SD Displays the cumulative calculated SD for the selected

module.
% CV Displays the cumulative calculated %CV for the selected

module.
N Displays the cumulative number of data points in the control

file for the selected module.
Range Displays the range of values in the control file for the selected
module.

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System Cumulative area
Mean Displays the cumulative calculated mean for the data for all
modules of the same type in a multimodule system.
SD Displays the cumulative calculated SD for the data for all

% CV Displays the cumulative calculated %CV for the data for all
N Displays the cumulative number of data points in the control

file for all modules of the same type in a multimodule system.
Range Displays the range of values in the control file for all modules
of the same type in a multimodule system.
Function buttons

Control Summary Details screen, page 743
Clear Control Failure flyout element descriptions

In the Clear Control Failure flyout, the operator can clear a control failure.
Element
Comment Displays a text box that is used to enter a required comment

when a control failure is cleared.

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Function buttons



Create a Levey-Jennings graph

Perform this procedure to create a Levey-Jennings graph to monitor quality control activity.
NOTE: The Levey-Jennings graph is not displayed if the values for expected mean and expected
1. On the menu bar, tap QC.
On the Quality Control Summary screen, the quality control (QC) summary data for all
modules is displayed.
– To create a Levey-Jennings graph for the same assay, control name, and lot number
for a maximum of four modules of the same type in a multimodule system, proceed to
step 3, page 747.
– To display the QC summary data for one module, tap a Module button.
NOTE: To display the QC summary data for calculated assays, tap the module number
of the processing module used to produce the constituent results.
3. To enter a date range, type a value in the Date Range box and type a value in the To box.
NOTE: The default date range is composed of the last 31 days, including the current date.
4. Tap Update.
NOTE: Control results that were run between and on the entered dates are included in the
QC summary data.
5. In the list of QC summary data, tap a maximum of six assay control levels for the same
assay, control name, and lot number.
NOTE: To filter the list of QC summary data, tap Search.
A maximum of three Levey-Jennings graphs can be viewed on the Levey-Jennings (Graph)
screen at the same time for the same module, control name, and lot number. Use the scroll
bar to display the remaining graphs.

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6. Tap Graph.
NOTE: The Graph button is unavailable if more than one assay or lot number is selected on
the Quality Control Summary screen.
7. On the Levey-Jennings (Graph) screen, tap a comparison type in the Comparison Type
drop-down list:
– None: A comparison method is not used.
– Manufacturer: This method compares the expected mean and expected SD to the
manufacturer's mean and SD that are configured for the control.
NOTE: If Manufacturer is configured, the manufacturer's mean and SD are displayed
as the Comparison Mean and Comparison SD elements on the left side of the Levey-
Jennings (Graph) screen. A dashed line indicates the manufacturer's mean on the
graph.
– Module Cumulative: This method compares the expected mean and expected SD to
the cumulative mean and cumulative SD of the selected module.
NOTE: If Module Cumulative is configured, the module cumulative mean and module
cumulative SD are displayed as the Comparison Mean and Comparison SD elements
on the left side of the Levey-Jennings (Graph) screen. A dashed line indicates the
module cumulative mean on the graph.
– System Cumulative: This method compares the expected mean and expected SD to
the cumulative mean and cumulative SD of all modules in a multimodule system.
NOTE: If System Cumulative is configured, the system cumulative mean and system
cumulative SD are displayed as the Comparison Mean and Comparison SD elements
on the left side of the Levey-Jennings (Graph) screen. A dashed line indicates the
system cumulative mean on the graph.
NOTE: The previous selections for module, assay, control name, lot number, control level,
and date range are displayed on the Quality Control Summary screen.
9. To create a Levey-Jennings graph for another assay, repeat steps 2, page 747 through 8,
page 748.
Display the value for a Levey-Jennings point, page 738
Exclude or include a Levey-Jennings point, page 738
View the details for a Levey-Jennings point, page 739
Add a comment to a Levey-Jennings point, page 739
Clear a control failure

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Perform this procedure to clear a control failure when the control material cannot be repeated to
obtain an acceptable value.
The control failure can occur as the result of a value that exceeds a control range or a
Westgard rule failure.
On the Quality Control Summary screen, the quality control (QC) summary data for all
modules is displayed.
2. To display the QC summary data for one module, tap a Module button.
NOTE: To display the QC summary data for calculated assays, tap the module number of
the processing module used to produce the constituent results.
3. In the list of QC summary data, tap an assay control level that has a control failure.
NOTE: An assay control level that has a control failure is displayed in red text on the Quality
Control Summary screen.
4. Tap Clear Control Failure.
5. In the Comment box in the Clear Control Failure flyout, type a comment.
6. To save the comment and return to the Quality Control Summary screen, tap Done.
NOTE: After the control failure is cleared, Message code 1171 is logged with the comment
and the text of the assay control level is displayed in black.
View the quality control (QC) summary data

Perform this procedure to view the quality control (QC) summary data for a specific control
level.
NOTE: The QC summary data is not displayed if the values for expected mean and expected
On the Quality Control Summary screen, the QC summary data for all modules is displayed.
– To view the QC summary data for the same assay, control name, and lot number for a
maximum of four modules of the same type in a multimodule system, proceed to step 3,
page 750.
– To display the QC summary data for one module, tap a Module button.
NOTE: To display the QC summary data for calculated assays, tap the module number
of the processing module used to produce the constituent results.

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4. Tap Update.
QC summary data.
View the control summary details

Perform this procedure to view the control summary details for a specific control level.
NOTE: The quality control (QC) summary data is not displayed if the values for expected mean
and expected standard deviation (1 SD) are not defined for the control.
On the Quality Control Summary screen, the QC summary data for all modules is displayed.
2. To display the QC summary data for one module, tap a Module button.
NOTE: To display the QC summary data for calculated assays, tap the module number of
the processing module used to produce the constituent results.
4. Tap Update.
QC summary data.
5. In the list of QC summary data, tap one or more assay control levels.
6. Tap Details.
7. If more than one assay control level was selected, tap Next or Previous on the Control
Summary Details screen to display each assay control level.
8. To return to the Quality Control Summary screen, tap Done.

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Section 5 Print flyout
Print flyout
Screen images, reports generated by the system, and Abbott Mail documentation can be printed
or can be saved as a portable document format (PDF) file. The system can be configured to
print or save the following reports automatically:
• Calibration details
• Result list
• Sample laboratory
• Maintenance
Reports and Abbott Mail documentation are available from related screens. The following table
provides the report availability:
To print the ... Access the ...
Abbott Mail Log Report System Logs screen, Abbott Mail tab
Absorbance Data Report Results screen
(c‑series)
Assay Information Report • Assay Parameters screen
• Install/Uninstall Assays screen
Assay Insert • Abbott Mail Inbox screen
• Reagent Cartridge Details screen
Assay Installation Report Abbott Mail Inbox screen
Assay Parameter Report Assay Parameters screen
Calibration Details Report Calibration Status screen
Calibration Summary Report Calibration Status screen
Calibrator Value Sheet • Calibrator Set View/Edit screen
NOTE: A calibrator value sheet is available only for a calibrator lot
that was created from an imported file.
• Abbott Mail Inbox screen
Configuration Log Report System Logs screen, Configuration tab
Control Insert Control Create/Edit screen
Diagnostic History Report Procedures Log screen
Exception List Report Results screen, Exceptions tab
Information Log Report System Logs screen, Informational tab
Interfaces Log Report System Logs screen, Interfaces tab
Inventory Log Report System Logs screen, Inventory tab
Licenses Report Utilities screen
Maintenance History Report Procedures Log screen
Notifications Log Report System Logs screen, Notifications/Alerts tab
Order List Report Orders screen

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Print flyout Section 5
To print the ... Access the ...

Print Verification Report Printers screen
Procedure Report Procedures screen
QC Analysis Report Quality Control Summary screen
QC Levey-Jennings Report Levey-Jennings (Graph) screen
QC Summary Report Quality Control Summary screen
Reagent Status Report Reagent screen
Rerun List Report Orders screen
Result Details Report Results screen
Result List Report Results screen
Sample Laboratory Report Sample Status screen
System Log Report System Logs screen
System Update Details Report System Update screen, All Messages tab
System Update Letter • Abbott Mail Inbox screen
• System Update screen
System Update List Report System Update screen
User Access Log Report System Logs screen, User Access tab
User-Defined Maintenance User-Defined Maintenance screen
Details Report
Print flyout element descriptions, page 752
Report File Location window element descriptions, page 754
View or print the Licenses Report, page 399
Print flyout element descriptions
Print Options
Displays the print options for report selections.
Print Location Displays a drop-down list of the following options:

• Configured printer
• Print to File

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Copies Displays a drop-down list of the number of copies that can be

selected to print. The default is one copy. A maximum of five
copies can be selected.
Print Selection Displays the print selection options: All Items or Selected
Items.
If no items were selected on the previous screen, the default
is the All Items option. The Selected Items option is
unavailable.
If one or more items were selected on the previous screen,
the default is the Selected Items option. The All Items option
is available.
Report Selection Displays a list of the reports that are available to print. A
preview of the selected report is displayed before the report is
printed.
PDF viewer area

Displays a preview of a portable document format (PDF) file that is downloaded or imported.
Rotate Used to rotate the PDF document clockwise or

counterclockwise.
Page Displays the number of pages in the PDF document. Each

page of the document can be viewed by tapping the Previous
Page button or the Next Page button or by typing a page
number to display to a specific page.
Zoom Used to increase or decrease the size of the PDF document

by tapping the Zoom In button or the Zoom Out button, by
typing a document size, or by tapping a document size in the
drop-down list.
Fit Used to resize the PDF document to fit the window width ( )
and enable the scroll bar, or to resize the document to fit one
full page in the window ( ).
Find Used to find a word or phrase in the PDF document. The Find
Previous button and the Find Next button are used to browse
the document to find the word or phrase.

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Function buttons

Print Prints the selected reports.
Previous Navigates to the previous PDF document if more than one

document was selected.
Next Navigates to the next PDF document if more than one

document was selected.
Text Size Increases or decreases the size of text displayed. This

function button is not displayed with the PDF viewer.

Report File Location window element descriptions

The Report File Location window displays the drive and folders that are used to save a report file
as a portable document format (PDF) file.
Elements

selected folder.

folders.
updated.

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Function buttons

Print a report
Perform this procedure to print a system-generated report to a configured printer or to save the
report as a portable document format (PDF) file.
1. On a screen, tap one or more items to include in the report.
NOTE: Items are printed in the order in which they are displayed on the screen. If a specific
item is not selected, all items are printed.
2. Tap Print.
4. In the Copies drop-down list, tap the number of copies to print (printer only).
5. Tap a Print Selection option.
NOTE: If one or more items were not selected, All items is the only available option.
6. In the Report Selection list, tap a report.
7. Tap Print.
d. Tap OK.
9. To return to the screen, tap Done.

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Print a screen image

Perform this procedure to print a screen image to save graphical or troubleshooting information.
1. On the screen header, tap the Abbott A button .
2. If the system is configured to save the print screen output as a file, perform the following
a. Tap the appropriate USB flash drive.
b. Tap the destination folder.
c. To save the file to the destination folder, tap OK.
To cancel the save function, tap Cancel.
Configure the print screen file output destination, page 213

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Section 5 Search flyout
Search flyout
In the Search flyout, the operator can search for specific data by entering search criteria.
Cal/QC Inventory screen, Search flyout element descriptions, page 589
Search for or filter data

Perform this procedure to search for specific data or to filter data on a screen.
1. On a screen, tap Search.
2. In the Search flyout, enter the search criteria.
To limit the search results, enter more criteria.
NOTE: Data is filtered based on the results that contain the criteria entered.
For example, if 123 is entered in the SID box, all search results that contain 123 are
displayed. The search results can include SID numbers 12345, 45123, and 41235.
3. To search for and display the filtered data, tap Done.
4. To display all records, tap Clear Filter.
Edit a user, page 176
Inactivate or activate a user, page 177
Manage user PINs, page 179
Verify vial inventory data, page 591
Add a comment to an order, page 668

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Search flyout Section 5

Delete a test from a sample order, page 692
Delete a sample result or an exception, page 727
Archive the calibrations, page 762
Transmit a calibration to the host, page 806

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Section 5 Archive flyout
Archive flyout
In the Archive flyout, the operator can archive specimen results, control results, or calibrations.
Archive flyout element descriptions, page 759
Archive File Location window element descriptions, page 760
Archive flyout element descriptions

The Archive flyout is used to archive data.
Elements
Archive Options
Archive Selection Displays the archive options. The Archive flyout has three
options:
All Items This option archives data within a

defined date range.
Incremental This option archives data that does not

have a status of Archived within a
defined date range.
Selected Items This option archives selected data.
From Used to enter a start date. A start date is available only for
the All Items option and the Incremental option.
To Used to enter an end date. An end date is available only for
the All Items option and the Incremental option.
Archive Mode Displays the archive modes. The Archive flyout has two
archive modes:
Only Archive This option saves archived data to a

USB flash drive.

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Archive flyout Section 5
Archive & Delete This option deletes data after all the
selected data has been archived to a
USB flash drive.
Function buttons

Archive Archives data and closes the flyout.

Archive File Location window element descriptions

The Archive File Location window displays the drive and folders that are used to save an
archive file.
Elements

selected folder.
Last Update Displays the date and time that files in the folder were last
updated.
Function buttons

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Archive the results

Perform this procedure to archive specimen and control results on a USB flash drive.
NOTE: The results are archived in an Excel file format with a digital signature and can be
imported into a spreadsheet. If the spreadsheet is edited, the digital signature is removed from
the Excel file. The archived results cannot be viewed on the Alinity ci‑series.
3. To archive released samples or released controls, tap the appropriate tab.
4. In the list on the tab, tap one or more results (or tap Select All).
NOTE: To filter the list of results, tap Search.
5. Tap Archive.
6. Under Archive Options in the Archive flyout, tap an Archive Selection option:
– All items: This option archives all results within a defined date range.
To enter a date range, tap From and enter a start date, tap To and enter an end date,
or enter both a start date and an end date.
– Incremental: This option archives all results that do not have a status of Archived within
a defined date range.
– Selected items: This option is available only if results were selected in step 4, page
761.
7. Tap an Archive Mode option:
– Only Archive: This option saves archived results to a USB flash drive.
– Archive & Delete: This option deletes results after all the selected results have been
archived to a USB flash drive.
NOTE: Results with a status of Pending Transmission or Pending Collation are not
deleted.

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Archive flyout Section 5
8. Tap Archive.
9. On the Archive File Location screen, tap the USB flash drive and folder to which to archive
the results.
10. Tap OK.
– Tap Yes to complete the archive process.
– Tap No to close the Archive flyout.
Archive the calibrations

Perform this procedure to archive active and inactive calibrations on a USB flash drive.
NOTE: The calibrations are archived in an Excel file format with a digital signature and can be
imported into a spreadsheet. If the spreadsheet is edited, the digital signature is removed from
the Excel file. The archived calibrations cannot be viewed on the Alinity ci‑series.
2. On the menu bar, tap CAL.
The Current tab of the Calibration Status screen displays the calibration data for all
modules.
3. On the Calibration Status screen, tap the Historical tab.
4. On the Historical tab of the Calibration Status screen, tap one or more calibrations (or tap
Select All).
NOTE: To filter the list of calibrations, tap Search.
5. Tap Archive.
6. Under Archive Options in the Archive flyout, tap an Archive Selection option:
– All items: This option archives all calibrations within a defined date range.

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– Incremental: This option archives all calibrations that do not have a status of Archived
within a defined date range.
– Selected items: This option is available only if calibrations were selected in step 4,
page 762.
7. Tap an Archive Mode option:
– Only Archive: This option saves archived calibrations to a USB flash drive.
– Archive & Delete: This option deletes inactive calibrations after all the selected
calibrations have been archived to a USB flash drive.
NOTE: If Archive & Delete is selected, only calibrations that have a status of Inactive are
deleted. If calibrations that have a status of Active are selected, an informational message
notifies the operator that calibrations are not deleted.
8. Tap Archive.
9. On the Archive File Location screen, tap the USB flash drive and folder to which to archive
the calibrations.
10. Tap OK.
– Tap Yes to complete the archive process.
– Tap No to close the Archive flyout.
Calibration review, page 795

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Insert and remove a USB flash drive Section 5
Insert and remove a USB flash drive

Perform this procedure to insert a USB flash drive into a USB port and to remove the USB flash
drive from the USB port on the user interface computer.
NOTE: USB flash drives that are software encrypted with password protection are not permitted
for use on the Alinity ci‑series.
1. Open the system control module (SCM) front door.
2. Insert the USB flash drive into a USB port.
3. After the procedure that uses the USB flash drive is completed, remove the USB flash drive
from the USB port.
Import users, page 178

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Section 5 Insert and remove a USB flash drive
Export users, page 179

Configure an automatic backup, page 240
View or print a calibrator value sheet (c‑series), page 320
Perform a manual backup, page 382
Copy a backup to a USB flash drive, page 383
Retrieve a troubleshooting package, page 396
Export assay files (c‑series), page 331
Import assay files (c‑series), page 332

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Insert and remove a USB flash drive Section 5
NOTES

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Section 6 Calibration procedures
Introduction
Calibration is the process used to analyze calibrators of a known concentration, to record
system response values, and to plot measured values against the known concentration.
Before performing sample processing, calibrate all assays.
Calibration guidelines, page 768
Calibration types and methods, page 769
Calibration storage, page 793

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Calibration procedures
Calibration guidelines Section 6
Calibration guidelines
After an assay is installed that requires a calibration, an active calibration must be generated. A
calibration is not required every time that an assay is run. However, a recalibration is required
with certain variables.
Mandatory assay A calibration must be performed when:

calibration
• A new reagent lot number is used.
• Assay documentation states that a calibration is required
when a reagent cartridge is changed.
• Documentation that accompanies a new version of an
existing assay file states that a calibration is required.
• A new assay file that requires a calibration is installed.
• The calibration has expired.
Optional assay A calibration may need to be performed when:

calibration
• Assay control values do not meet required specifications.
For specific information about quality control, see the
manufacturer's documentation.
• Certain system maintenance procedures or component
replacement procedures are performed.
• Certain errors occur. To determine whether a
recalibration is required when an error occurs, see assay-
specific message codes.
Running all levels of appropriate controls is recommended when an assay is calibrated.

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Section 6 Calibration types and methods
Calibration types and methods

Calibration types and methods define the system-specific processes that are used to create a
calibration curve or determine a cutoff value.
Calibration method (c‑series potentiometric), page 769
Calibration types and methods (c‑series photometric), page 774
Calibration types and methods (i‑series), page 784
Calibration method (c‑series potentiometric)

The potentiometric calibration method is used to calculate results for the ICT assays of sodium
(Na+), potassium (K+), and chloride (Cl-). Serum and urine calibrators are available for use and
contain known concentrations of electrolytes. The serum calibrators are protein-based materials.
The urine calibrators are aqueous-based materials that span a greater concentration range.
The millivolts measured by each electrode of the ICT module are plotted against the known
concentration of electrolyte in the calibrator. The slope of the calibration is expressed as a
percentage of the ideal slope. Electrolyte determinations are made at 37°C. Therefore, the ideal
slope of the electrode is 100% (61.5 millivolts per decade).
The potentiometric calibration method is specific to these assays, is defined in the system
software, and has three components:
• Electromotive force measurement
• Slope calculation
• Sample measurement
Electromotive force measurement (c‑series potentiometric), page 769
Slope calculation (c‑series potentiometric), page 770
Sample measurement (c‑series potentiometric), page 772
Electromotive force measurement (c‑series potentiometric)

The electromotive force measurement uses the potential difference between the electromotive
force of an unknown sample and the electromotive force of the ICT Reference Solution,
measured immediately after the sample, to determine the electrolyte concentration.

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Calibration types and methods Section 6
Figure 150: Electromotive force calculation
Where:
E Electromotive force expressed in millivolts
T Time
ΔEi Potential difference between the sample and the ICT

Reference Solution for each electrode
Ei Potential of each electrode (i) in contact with the sample
i Ion of interest (Na+, K+, and Cl-)
EB Potential of each electrode (i) in contact with the ICT

Reference Solution
Slope calculation (c‑series potentiometric)

The slope calculation uses the potential differences between the electromotive forces of two
calibrators and the electromotive force of the ICT Reference Solution and compares them to the
calibrator concentrations to generate a calibration curve. When the calculation occurs, the
system software generates two graphs:
• A calibration graph that shows the relationship between the ion concentration and the
electromotive force

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• An electrode response curve during calibration
Figure 151: Relationship between the ion concentration and the electromotive force
Electromotive force is derived from the Nernst equation:

E = E0 + S logCi:
Where:
E0 Electromotive force under standard conditions
S Slope (millivolts per decade) of each electrode
CL, CH Concentration of low and high calibrators
CN Concentration of the ICT Reference Solution
ΔEL, ΔEH Potential difference between the ICT Reference Solution and
the calibrator for each electrode
logCi Logarithm of the concentration of the ion of interest

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Figure 152: Electrode response curve during calibration
Where:
ΔEL, ΔEH Potential difference between the ICT Reference Solution and
the calibrator for each electrode
T Time
EL Electromotive force of the low calibrator
EH Electromotive force of the high calibrator
EN, EN' Electromotive force of the ICT Reference Solution
Sample measurement (c‑series potentiometric)

The sample measurement uses the following data to determine the electrolyte (ICT)
concentration in an unknown sample:
• The difference between the electromotive forces of the unknown sample and the ICT
Reference Solution
• The difference between the electromotive forces of the low calibrator and the ICT
Reference Solution

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• The slope of the specific ICT electrode
The electrolyte concentration is calculated by using the following equation:

− ΔEL / S
Ci = CL × 10 ΔEi
Figure 153: Electrode response curve during sample measurement
Where:
Ci Concentration of the ion of interest in the sample
CL Concentration of the ion of interest in the low calibrator

(baseline for sample calculations)
ΔEi Difference in the electrode potential when exposed to the

sample and the ICT Reference Solution
ΔEL Difference in the ICT electrode potential when exposed to the

ICT Reference Solution and the low calibrator during
calibration
S Slope of the ICT electrode of interest
EN Electromotive force of the ICT Reference Solution
Ei Electrode potential of the sample for the ion of interest
T Time

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ICT index
An index solution can be used to compensate for differences between ICT modules, day-to-day
instrument variations, and matrix differences between calibrators and patient samples. The index
solution is a sample with a known concentration and is used during calibration of an ICT analyte.
After calibration is completed, sample measurements are adjusted automatically.
Measured sample values are adjusted by using the following equation:
Conc' = Conc - (Comp' - Comp)
Where:
Conc' Adjusted ICT sample value
Conc Measured ICT sample value (not adjusted)
Comp' Measured value of the index solution
Comp Nominal index concentration (known value)
(Comp' - Comp) Adjustment value
The measured value of the index solution for the specific analyte is calculated by using the
following equation:
− ΔEL / S
Ci = CL × 10 ΔEi
NOTE: When the index concentration is set to zero, the index value is not calculated.
Calibration types and methods (c‑series photometric)

Two c‑series assay calibration types, full and adjustment, apply only to photometric assays and
indicate whether a calibration curve is created or adjusted.
The photometric calibration methods use measured absorbance values to plot a calibration curve
or to determine a cutoff value.
The system software provides six full calibration methods and three adjustment calibration types.
The type and method are defined in each assay parameter file.
For information about calibration types and methods for an assay, see the assay documentation.
Full calibration (c‑series photometric), page 775

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Full calibration (c‑series photometric)

A full calibration for an assay is the measurement of a reagent blank and all specified data
points. The absorbance value for each point is plotted against the known concentration and the
system software generates a new calibration curve. Unknown samples are then evaluated
against the calibration curve.
A full calibration is necessary to update the full calibration interval.
Absorbance method (c‑series photometric), page 775
Factor method (c‑series photometric), page 775
Linear method (c‑series photometric), page 776
Logit-4 method (c‑series photometric), page 778
Spline method (c‑series photometric), page 779
Use cal factor blank method (c‑series photometric), page 781
defined), page 1556
Absorbance method (c‑series photometric)

The absorbance data reduction method uses the comparison between the absorbance of the
sample and the absorbance of water to calculate results. For end-point assays, the data is
expressed as absorbance. For rate assays, the data is expressed as the rate of absorbance
change per minute.
Factor method (c‑series photometric)

The factor data reduction method uses a reagent blank and a fixed calibration factor value to
calculate results. This method is applicable to assays for which the reaction is linear and stable
across all reagent lots. This method is used to measure enzyme activity in a sample at a
predictable and steady rate that can be determined for the chromophore, wavelengths, and
processing module in use.
The enzyme activity or the sample concentration is calculated by using the following equation:
X = (A - Ablk) x Factor
Where:
X Activity or concentration of the unknown sample
A Absorbance or absorbance change of the unknown sample

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Ablk Absorbance or absorbance change of the reagent blank
Factor Calibration factor
Linear method (c‑series photometric)

The linear data reduction method uses a reagent blank and one to six calibrators to generate a
point-to-point calibration curve. The slope is calculated for each segment of the curve between
calibrator levels.
Figure 154: Linear calibration curve for six calibrators
Where:
Abs Absorbance
Conc Concentration
blk Concentration of the reagent blank
C1 to C6 Concentration of the calibrator

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Ac1 to Ac6 Absorbance or absorbance change of the calibrator
The absorbance or absorbance change that is measured for the sample determines which of the
following equations are used to calculate the sample concentration.
When A ≤ Ac1, X = F1 x (A - Ablk) + blk
C1 − blk
F1 = Ac1 − Ablk
When Ac1 < A ≤ Ac2, X = F2 x (A - Ac1) + C1

C2 − C1
F2 = Ac2 − Ac1

C3 − C2
F3 = Ac3 − Ac2

C4 − C3
F4 = Ac4 − Ac3

C5 − C4
F5 = Ac5 − Ac4
When Ac5 < A, X = F6 x (A - Ac5) + C5

C6 − C5
F6 = Ac6 − Ac5
Where:
Ac1 to Ac6 Absorbance or absorbance change of the calibrator
X Concentration of the unknown sample
C1 to C6 Concentration of the calibrator
F1 to F6 Cal factor (1/slope)

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Logit-4 method (c‑series photometric)

The logit-4 data reduction method uses a reagent blank and three to six calibrators to generate
a calibration curve. This method is applicable to assays for which the absorbance or absorbance
change increases as the calibrator concentration increases.
Figure 155: Logit-4 calibration curve for three to six calibrators
Where:
Abs Absorbance
Conc Concentration
C1 to C(N) Concentration of the calibrator
Ac1 to Ac(N) Absorbance or absorbance change of the calibrator
An approximation is calculated by using the following equation:

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Kc
A = 1
+ Ablk
1 +
e a + b × lnX
Where:
Kc, a, b Constants of the approximation expression
Ablk Approximate value of the absorbance or absorbance change

of the reagent blank
ln Natural log
When the concentration is near zero, the logit-4 calibration curve converges asymptotically
toward the absorbance or absorbance change of the reagent blank as the concentration
approaches zero. A graph may not show this convergence if the scale is too large.
The approximation expression is simple and the constant is determined through an approximation
by nonlinear regression. Therefore, the curve may not consistently pass through the absorbance
(or absorbance change) data points of the calibrator.
A parameter is available to detect an error if the standard deviation of the absorbance or
absorbance change of the calibrators exceeds a specified value.
Spline method (c‑series photometric)

The spline data reduction method uses a reagent blank and three to six calibrators to generate a
calibration curve. The concentration axis of the calibration curve graph is divided into multiple
sections. The sections correspond to the concentrations of the calibrators. Each section of the
curve is interpolated by using a polynomial equation so that the adjoining sections are connected
smoothly.

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Figure 156: Spline calibration curve for three to six calibrators
Where:
Abs Absorbance
Conc Concentration
C1 to C(N) Concentration of the calibrator
Ac1 to Ac(N) Absorbance or absorbance change of the calibrator
An interpolation is calculated by using the following polynomial equation:

A = a(n) + b(n) x X + c(n) x X2 + d(n) x X3
Where:
a(n), b(n), c(n), d(n) Constants of the approximation expression

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Use cal factor blank method (c‑series photometric)

The use cal factor blank calibration method uses the factor and reagent blank of a calibration
curve generated for another assay (reference assay) to calculate results. This method is used
when two or more assays use the same reagent and have the same sample volume to reagent
volume ratios. The reference assay is defined in an assay parameter file.
The unknown sample concentration is calculated by using the following equation:
A − Ablk′
X = Ac1′ − Ablk′
× C1′
Where:
Ac1' Absorbance or absorbance change of the calibrator used for

the reference test
Ablk' Absorbance or absorbance change of the reagent blank used

for the reference test
C1' Concentration of the calibrator used for the reference test
Adjustment calibration (c‑series photometric)

An adjustment calibration uses one of the following measurement options:
• A new measurement of a reagent blank
• A new measurement of one specific point of a full calibration curve
• A new measurement of a reagent blank and one specific point of a full calibration curve
The system software uses the new measurements to adjust the existing calibration data points
and then generates a new calibration curve.
The adjustment calibration interval is updated when either a full calibration or a designated
adjustment calibration is performed.
The c‑series provides the following adjustment options:
• Blank adjustment
• 1-point adjustment

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• 2-point adjustment
Blank adjustment (c‑series photometric), page 782
1-point adjustment (c‑series photometric), page 782
2-point adjustment (c‑series photometric), page 783
defined), page 1556
Blank adjustment (c‑series photometric)

In a blank adjustment, the system reanalyzes only the reagent blank. The following steps show
how the calibration curve is adjusted with the new reagent blank data. The calibration curve is
plotted as absorbance (Abs) versus concentration (Conc).
Step Description
1 The system software performs the new measurement (Ablk')
for the reagent blank (Ablk).
2 The new reagent blank absorbance value (Ablk') replaces the

previous value and the curve adjusts up or down based on the
new reagent blank value.
3 The system software generates a new calibration curve.
1-point adjustment (c‑series photometric)

In a 1-point adjustment, the system reanalyzes one calibrator. The calibrator used is defined on
the Calibration tab of the Assay Parameters screen. The following steps show how the

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calibration is adjusted with the new calibrator data. The calibration is plotted as absorbance
(Abs) versus concentration (Conc).
Step Description
1 The system performs the new measurement (A2') for the
designated adjustment calibrator (A2).
2 A ratio (R) that compares the new (A2') and previous (A2)
absorbance data is calculated:
All other calibrators (A1 and A3) are adjusted by using the
calculated ratio. The adjusted absorbance values are A1' and
A3'. The reagent blank is not adjusted.
3 The system software uses the adjusted data points to

generate a new calibration.
2-point adjustment (c‑series photometric)

In a 2-point adjustment, the system reanalyzes the reagent blank and one calibrator. The
calibrator used is defined on the Calibration tab of the Assay Parameters screen. The following
steps show how the calibration is adjusted with the new calibrator data. The calibration is plotted
as absorbance (Abs) versus concentration (Conc).
Step Description
1 The system performs the new measurement (Ablk') for the
reagent blank (Ablk).

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Step Description
The system performs the new measurement (A2') for the
designated adjustment calibrator (A2).
2 The new reagent blank absorbance value (Ablk') replaces the

previous value and the curve adjusts up or down based on the
change in the reagent blank.
A ratio (R) that compares the new (A2') and previous (A2)
absorbance data is calculated:
All other calibrators (A1 and A3) are adjusted by using the
calculated ratio. The adjusted absorbance values are A1' and
A3'.
3 The system software uses the adjusted data points to

generate a new calibration.
Calibration types and methods (i‑series)

A calibration type indicates whether a new calibration curve is created, a master reference curve
is adjusted, or a cutoff value is created for i‑series assays on a processing module. The system
software uses a specific calibration method to create each calibration. The type and method are
defined in each assay parameter file and are specific to the assay. For a detailed description of
assay calibrators and calibration types and methods for an assay, see the assay documentation.

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Full calibration (i‑series), page 785
Index calibration (i‑series), page 792
Reference method (i‑series), page 792
Full calibration (i‑series)

A full calibration is a measurement of six points specified for a quantitative assay plotted against
known concentrations. The system software uses calibration data to generate a calibration curve
that is specific to a processing module. A full calibration is created by using one of the three
calibration (data reduction) methods that the Alinity i‑series provides.
Point-to-point method (i‑series), page 785
Linear regression method (i‑series), page 786
4PLC methods (i‑series), page 787
Point-to-point method (i‑series)

The point-to-point data reduction method uses the average relative light unit (RLU) value
obtained for each calibrator compared to the calibrator concentration (Conc) to generate a
calibration curve. A straight line is used to connect each point. The slope is calculated for each
line segment. Concentrations of unknown samples are calculated from the line segment that
brackets sample RLU values.
Figure 157: Point-to-point data reduction method
For example, if a sample has an RLU value between the RLU values for calibrator B and
calibrator C, the unknown sample concentration is calculated by using the following equation:
Conc (C) − Conc (B)
Conc (X) = RLU (C) − RLU (B)
× RLU (X) − RLU (B) + Conc (B)

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Linear regression method (i‑series)

The linear regression data reduction method uses the linear relationship between the relative
light unit (RLU) value and the concentration of the analyte in the sample to generate a
calibration curve. The curve is calculated by using the following equation:
RLU = Intercept (b) + Slope (m) x Concentration (Conc)
Figure 158: Linear regression data reduction method
The unknown specimen concentration is calculated by using the following equation:

RLU − b
Conc = m
Slope (m) and intercept (b) are obtained from the calibration. To calculate the slope and the
intercept, the system software minimizes the sum of squares of the difference between an
observed value and a predicted value (by the regression equation) for all calibrators. The
following equations show the calculations:
S xx × S y − S x × S xy
b = Δ
S × S xy − S x × S y
m = Δ
Δ = S × Sxx − S2x
1
S = Σ 2
σi
xi
sx = Σ 2
σi
yi
Sy = Σ 2
σi
x 2i
Sxx = Σ 2
σi
xi × yi
Sxy = Σ
σ 2i
Where:
σi Standard deviation associated with a calibrator
xi Observed calibrator concentration

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yi Observed calibrator RLU value
4PLC methods (i‑series)

Data reduction methods for four-parameter logistic curve fit or four-parameter logistic calibration
(4PLC) use the difference between predicted and observed calibrator concentrations (Conc) or
signals to generate a calibration curve.
A 4PLC curve is calculated by using the following equation:
P2
RLU = P1 +
P3 + Conc P4
Four parameters (P1 through P4) control the shape of the curve. Based on the data generated,
a 4PLC curve can be sigmoidal (S-shaped) or can have a shape with no second bend.
The following list shows how the four parameters are used:
P1 Defines the signal at an infinite concentration

P2
P3
Defines the maximum theoretical range of a relative light unit
(RLU) value from zero concentration to infinity
1
P4
X50 = P Defines the concentration that yields a signal midway between
3
the highest possible signal and the lowest possible signal
P4 Determines whether the curve is S-shaped. The curve is S-

shaped when P4 is greater than 1.
These parameters are calculated to find the P values that generate a curve with the lowest sum
of squares:
1
P2 P4
Conc = RLU − P1
− P3
The 4PLC data reduction methods are an x residual minimization (x-weighted) method and a y
residual minimization (y-weighted) method.
4PLC with x residual minimization (x-weighted) method
The 4PLC with x residual minimization (x-weighted) method uses the difference between
predicted and observed calibrator concentrations to generate a calibration curve. To generate a
curve with the lowest possible sum of squares, the four parameters are calculated by using the
following equation:
xi − xi 2
Σ σi

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Where:
xi Observed calibrator concentration
xi Predicted calibrator concentration
4PLC with y residual minimization (y-weighted) method
The 4PLC with y residual minimization (y-weighted) method uses the difference between
predicted and observed calibrator signals to generate a calibration curve. To generate a curve
with the lowest possible sum of squares, the four parameters are calculated by using the
following equation:
yi − yi 2
Σ = σi
Where:
yi Observed calibrator signal (RLU value)
yi Predicted calibrator signal (RLU value)
Adjustment calibration (i‑series)

An adjustment (adjust) calibration is a measurement of two points of a master reference curve
specified for an assay. The system software uses master calibration data to generate a
calibration curve that is specific to a processing module when quantitative assays are used.
A two-point adjust calibration assay has master calibration data encoded within a two-
dimensional bar code on the reagent cartridge label. After the operator loads a reagent cartridge
on a processing module, the system performs a scan and stores master calibration data in the
system software. The stored data is specific for the assay, but the data must be adjusted to fit a
specific processing module. Therefore, the operator must run two calibrators.
The Alinity i‑series provides four methods of calibration adjustment.
Ratio technique methods (i‑series), page 789
Linear transformation method (i‑series), page 790
Parameter method (i‑series), page 790

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Curve shape methods (i‑series), page 791

Ratio technique methods (i‑series)

The ratio technique adjustment methods compare the relative light unit (RLU) value of calibrators
to the corresponding calibrator values from a master calibration curve. This technique is used
when the lower end of the calibration curve has different characteristics than the rest of the
curve, but the general behavior of the curve is still proportional and linear.
Ratios are calculated for calibrator 1 and calibrator 2 by using the following equations:
C1
R1 = M1
Where:
R1 Ratio 1
C1 RLU value measured for calibrator 1
M1 RLU value stored in a reagent bar code for a calibrator that

corresponds to calibrator 1
C2
R2 = M2
Where:
R2 Ratio 2
C2 RLU value measured for calibrator 2
M2 RLU value stored in a reagent bar code for a calibrator that

corresponds to calibrator 2
The system software uses two types of ratio techniques, A and AB. The type that is used
depends on which master calibrator level is multiplied by ratio 1 and ratio 2.
Both types of ratio techniques produce estimates of RLU values. The following calculations are
used to determine the estimates:
Ratio A technique The RLU value stored in the reagent bar code for calibrator A
adjustment method is multiplied by ratio 1.
The RLU value stored in the reagent bar code for calibrators
B through F is multiplied by ratio 2.
Ratio AB technique The RLU value stored in the reagent bar code for calibrators
adjustment method A and B is multiplied by ratio 1.

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The RLU value stored in the reagent bar code for calibrators
C through F is multiplied by ratio 2.
The estimates of instrument-specific RLU values are used to generate the calibration curve.
Linear transformation method (i‑series)

The linear transformation adjustment method assumes a linear relationship between the
calibrator relative light unit (RLU) values that are generated by the system and the master
calibration information that is stored in a reagent bar code.
The following equations show an example of this method. The slope and the intercept that
describe the linear relationship are based on the RLU values of calibrator 1 and calibrator 2 that
are generated by the system and on the corresponding RLU values that are stored in the reagent
bar code.
The slope (m) and the intercept (b) are calculated by using the following equations:
C2 − C1
m = M2 − M1
C2 − C1
b = C1 − M1 × M2 − M1
Where:
C Calibrator
M Master
Instrument-specific RLU values for the six calibrators in the master calibration can be estimated
by using the following equation:
Calibrator1 = Master1 x Slope + Intercept
The estimates of the instrument-specific RLU values for the six calibrators are used to generate
a calibration curve by using the appropriate calibration curve model.
Parameter method (i‑series)

The parameter adjustment method uses relative light unit (RLU) values that are stored in a
reagent bar code for calibrators A through F to determine the four-parameter logistic curve fit or
four-parameter logistic calibration (4PLC) parameters of a master calibration. Calibrator 1 and
calibrator 2 adjusters are used to provide an instrument-specific calibration curve that is based
on the parameters.
For this method, the residual sum of squares is calculated by using the following equation:

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P j − Pj 2 yi − yi 2
Σ σj
+ Σ σi
Where:
Pj Population average parameter
Pj System-specific parameter
σj Standard deviation parameter
yi Predicted calibrator signal
yi Observed calibrator signal
σi Standard deviation of a calibrator signal
Curve shape methods (i‑series)

The curve shape adjustment methods use relative light unit (RLU) values that are stored in a
reagent bar code for calibrators A through F to determine the four-parameter logistic curve fit or
four-parameter logistic calibration (4PLC) parameters of a master calibration. Calibrator 1 and
calibrator 2 adjusters are used to provide an instrument-specific calibration curve that is based
on the shape of the curve.
For this method, the residual sum of squares is calculated by using the following equation:
Sj − Sj 2 yi − yi 2
Σ σj
+ Σ σi
Where:
Sj Population average shape parameter
Sj System-specific shape parameter
σj Standard deviation shape parameter
yi Predicted calibrator signal
yi Observed calibrator signal
σi Standard deviation of a calibrator signal

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Index calibration (i‑series)

An index calibration is a measurement of one point or two points specified for a qualitative
assay. The system software uses calibration data to generate an index (cutoff) value that is
specific to a processing module.
Cutoff assay method (i‑series), page 792
Cutoff assay method (i‑series)

The cutoff assay data reduction method measures relative light unit (RLU) values and calculates
a cutoff value. This method uses a one-point or two-point calibration to calculate the point
(cutoff) value where reactive and nonreactive samples are differentiated. Cutoff formulas can
use addition, subtraction, and multiplication, and constants can be added. After the cutoff value
is calculated, the unknown sample RLU value is divided by the cutoff value to determine a cutoff
ratio (index).
The system software uses the following cutoff calibration methods:
One-point qualitative This method uses one calibrator in the index formula. Based
(index formula) on the cutoff formula, the calibrator can be either reactive or
method nonreactive for an assay.
The following example is a one-point cutoff formula where a
and b are assay-specific constants:
Cutoff = a x Calibrator RLU + b
Two-point qualitative This method uses two calibrators in the index formula. The
(index formula) calibrator concentrations are based on the cutoff formula.
method
The following example is a two-point cutoff formula where a
and b are assay-specific constants:
Cutoff = a x Calibrator 1 RLU + Calibrator 2 RLU - b
Index calibration (i‑series), page 792
Reference method (i‑series)

The reference data reduction method uses a calibration curve generated for another assay
(reference assay) to calculate results. This method is used when two or more assays use the
same reagent. The reference assay is defined in an assay parameter file.

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Section 6 Calibration storage
Calibration storage
The Alinity ci‑series stores active, inactive, and failed calibrations.
Active calibration storage, page 793
Inactive calibration storage, page 794
Failed calibration storage, page 794
Active calibration storage

The system stores active calibrations according to the following guidelines:
• A calibration that is specific to a processing module is stored as the active calibration for
the reagent lot. If the system is configured to require calibration by cartridge, the calibration
is stored as the active calibration for the reagent lot and cartridge combination.
• If the system is configured to require quality control to run after a calibration is generated,
the status of the calibration is Pending QC.
NOTE: A calibration that has a status of Pending QC is considered to be an active
calibration that cannot be used to process tests until one level of quality control is
completed.
• The active calibration replaces any previous calibrations that have a status of Active,
Expired, Overridden, Overridden Lot, or Pending QC. For previous calibrations that have
these statuses, their statuses change to Inactive.
• The system automatically uses the active calibration as the default calibration for the
onboard reagent lot or the onboard reagent lot and cartridge combination.
• Stored calibrations that have a status of Failed are deleted for the reagent lot, or the
reagent lot and cartridge combination, that is specific to a processing module.
• One active calibration is stored for a maximum of four different reagent lots, or four
different reagent lot and cartridge combinations, for each assay on a processing module.
• When a fifth reagent lot or a fifth reagent lot and cartridge combination is calibrated
successfully, the system replaces the oldest active calibration and the status of the
calibration changes to Inactive.
• Stored active calibrations are deleted when the corresponding assay file is deleted.
NOTE: On the Calibration Details screen, the statuses of active calibrations can be manually
changed to Failed.

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Calibration storage Section 6
Fail a calibration, page 806
Inactive calibration storage

The system stores the previous calibration as an inactive calibration when a new calibration is
generated for the reagent lot, or the reagent lot and cartridge combination, that is specific to a
processing module. Inactive calibrations are stored for a maximum of 3 months.
All calibrations are deleted from the system when the last cartridge of a reagent master lot is
deleted. The system deletes reagents when the reagent cartridge storage capacity is exceeded.
In addition, reagents are deleted when c‑series user-defined assays are deleted manually.
Failed calibration storage

The system stores a failed calibration until an active calibration or another failed calibration is
generated for the reagent lot, or the reagent lot and cartridge combination, that is specific to a
processing module.

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Section 6 Calibration review
Calibration review
An assay calibration run must pass calibration verification before the system stores the
calibration. The status of each calibration is displayed on the Current tab and the Historical tab
of the Calibration Status screen.
System calibration verification, page 795
Calibration Status screen, page 796
View the assay calibration status, page 805
Transmit a calibration to the host, page 806
Fail a calibration, page 806
System calibration verification

After calibrators are processed, the system verifies the results by comparing them to the
calibration parameters and calibration validity checks that are specific to an assay. If the results
of a calibration fall within the specified range for the assay, the new calibration replaces any
previous calibration and the status of the previous calibration changes to Inactive. If the results
of a calibration fall outside the specified range for the assay, the status of the new calibration is
Failed. If the assay has an existing calibration, the calibration is not replaced. Unless otherwise
indicated, calibration statuses are displayed on the Current tab and the Historical tab of the
Calibration Status screen, and include the following options:
Active The calibrator values fall within the assay specifications. The
system software calculates patient and control test results
from this calibration.
Pending QC The calibrator values fall within the assay specifications. The
system is configured to require quality control to run after a
calibration is generated, and no control sample has
completed. When one control level for the assay is
completed, a calibration status of Active is displayed.
NOTE: A completed control does not require the control result
to fall within the configured specifications.
Failed The calibrator values fall outside the assay specifications. If a

reagent lot has an existing active calibration, the system
software calculates patient and control test results from the
existing active calibration.

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Calibration review Section 6
Inactive This status is associated with an older, previously active

calibration that was replaced by a more recent calibration.
This status is displayed only on the Historical tab of the
Calibration Status screen.
Calibration Status screen

On the Calibration Status screen, the operator can view a list of the calibration statuses for
assays and reagent lots that are loaded on the system.
• Search for specific calibrations based on specified search criteria.
• Access calibration details.
• Fail a calibration.
• Print a calibration report.
Calibration Status screen, Search flyout element descriptions, page 798
Calibration Status Details screen, page 800
Calibration Status screen element descriptions
Current tab, Historical tab

The Current tab displays the current calibration information for reagents loaded on the system
based on the last reagent scan. The Historical tab displays all calibration information on the
system for up to 3 months.
Elements

information. The Module bar is available only on the Current
tab.
An amber badge is displayed on the module number when a
calibration is within 1 hour of expiration.

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A red badge is displayed on the module number when a

calibration has expired or failed.
Module Displays the module on which the calibration was ordered and
processed. The module number is displayed only when the All
button is selected.
Calibration Method Displays the data reduction method defined for the assay.
The following c‑series methods are displayed:
• Abs (Absorbance)
• Factor
• Linear
• Logit-4
• Spline
The following i‑series methods are displayed:

• Point to Point
• Linear Regression
• 4PLC X
• 4PLC Y
• 4PLC X Transform
• Qual 1 Point
• Qual 2 Point
• Reference
• No Cal
Reagent Lot Displays the lot number of the reagent.
Cal Date/Time Displays the completion date and time of the calibration.
Status Displays the calibration status of the reagent lot.
Expiration Date/Time Displays the expiration date and time of the full or adjustment
calibration.

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Function buttons
Archive Displays the Archive flyout. This function button is displayed

only on the Historical tab.
current screen.
Calibration Status screen, Search flyout element descriptions

In the Search flyout of the Calibration Status screen, the operator can enter specific data that is
Elements
This search element is available only on the Current tab when
the All button is selected and on the Historical tab.
Reagent Lot Displays a text box that is used to search by the reagent lot
number.
Expires (In Hours) Displays a text box that is used to search for calibrations that
will expire within a specific number of hours. The search
range is from 1 hour through 24 hours.

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Calibration Status Displays check boxes that are used to search by the
calibration statuses. The Search flyout on the Current tab has
eight calibration statuses:
• Active
• In Process
• Pending QC
• No Cal
• Expired
• Failed
• Overridden
• Overridden Lot
The Search flyout on the Historical tab has seven calibration

statuses:
• Active
• Inactive
• Pending QC
• Expired
• Failed
• Overridden
• Overridden Lot
Archive Status Displays check boxes that are used to search by the archive
statuses. This search element is available only on the
Historical tab. The Search flyout has two archive statuses:
• Archived
• Not Archived
Function buttons



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Calibration Status Details screen

On the Calibration Status Details screen, the operator can view the following information:
• Details for calibrations
• Calibration graphs only for c‑series
The operator can fail a calibration.
Calibration Status Details screen element descriptions

The Calibration Status Details screen displays the details of the assay, reagent, and calibrator
information that are used to generate a calibration.
Assay and Reagent Information area

Displays assay, reagent, operator, and instrument information.
Assay Name Displays the name of the assay.
Assay Number Displays the number defined for the assay. The assay number
must be the same number that is used for the host.
Assay Version Displays the version defined for the assay.
Reagent Lot Displays the lot number of the reagent cartridge.
Lot Expiration Displays the lot expiration date of the reagent cartridge.

system when the calibration was performed.
Processing Module Displays the module used to order and process the
calibration.

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Module SN Displays the serial number of the module used to order and
process the calibration.
Calibration Information area

Displays the details of the calibration information.
Calibration Status Displays the calibration status of the reagent lot.
Calibration Type Displays the calibration type for the assay.
Calibration Method Displays the mathematical procedure used to analyze the

data.
Calibration Date/Time Displays the completion date and time of the calibration.
Calibrator Lot Displays the lot number of the calibrator used to calibrate the
assay.
calibrator lot number is displayed first, followed by the blank
calibrator lot number.
Lot Expiration Displays the lot expiration date of the calibrators used to
calibrate the assay.
calibrator lot expiration date is displayed first, followed by the
blank calibrator lot expiration date.
Full Curve Expiration Displays the expiration date and time of the full calibration.
This element is available only for assays that have a defined
calibration interval.
Adjustment Curve Displays the expiration date and time of the adjustment
Expiration calibration. This element is available only for assays that have
a defined calibration interval.
Archive Status Displays the following status information:
Archived The data has been successfully

archived.
Not Archived The data has not been successfully

archived.
Archive Date/Time Displays the date and time that the data was archived.

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Transmission Status Displays the transmission status information, which is used to

determine the progress of a transmission.
Transmission Date/ Displays the date and time that the archive record was
Time transmitted.
Message Code Displays the message code number and description.
Calibrator Results area

Displays the calibration details. Calibration information that is displayed varies based on the
assay type and the calibration method.
Current Calibration Displays the last active calibration. This information is

Curve displayed only for c‑series.
Previous Calibration Displays the previous active calibration. This information is

Curve displayed only for c‑series.
NOTE: A failed calibration will not be displayed.
Cutoff Displays the calculated cutoff value used for assay data
reduction.
Cal 1 Ratio, Cal 2 Displays the ratios calculated for calibrator 1 and calibrator 2.
Ratio This information is displayed only for i‑series.
Calibrator ID Displays the name of the calibrator level.
Conc Displays the concentration value for each calibrator level

defined in the assay parameters. Values are displayed with
the configured assay units.
For c‑series assays that use the use cal factor blank
calibration method and i‑series assays that use the reference
calibration method, values are displayed with the configured
units of the reference assay.
Fit Conc Displays the fit curve concentration value for each calibrator
level defined in the assay parameters. Values are displayed
with the configured assay units.
This information is displayed only for i‑series. For i‑series
assays that use the reference calibration method, values are
displayed with the configured units of the reference assay.

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%CV Displays the calculated percent coefficient of variation for the

calibrator.
Cal mV Displays the median millivolt value for each calibrator level.
This information is displayed only for c‑series potentiometric
assays.
Absorbance Displays the median absorbance value for the calibrator level.
Factor Displays the calibration factor for the calibrator level.
Slope Displays the percent response of the integrated chip

technology (ICT) module for the low and high calibrators. This
information is displayed only for c‑series potentiometric
assays.
Mean RLU Displays the mean relative light units (RLUs) of the calibrator
replicates. This information is displayed only for i‑series.
Reference Cal RLU Displays the reference (master calibrator) data read from the
reagent bar code label. This information is displayed only for
i‑series.
Fit RLU Displays the fit curve RLU data for each calibrator. This
information is displayed only for i‑series.
Rep 1, Rep 2, Rep 3 Displays the absorbance value, the millivolt value, or the RLU
value for replicates 1, 2, and 3.
Rep 1 RLU, Rep 2 Displays the RLU value for replicates 1, 2, and 3. This
RLU, Rep 3 RLU information is displayed only for i‑series.
Function buttons

Fail Invalidates the current calibration.

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Calibration Status Details screen, page 800
Descriptions of calibration statuses

The following list provides descriptions of the calibration statuses. The statuses are described in
the order in which they are sorted. Unless otherwise indicated, the statuses are displayed on the
Current tab and the Historical tab of the Calibration Status screen:
Failed One of the following situations occurred:

• The calibration failed an assay-specific calibration
parameter or assay-specific calibration validity checks.
• The calibration was not completed successfully because
of a hardware error.
• The operator manually failed the calibration.
Expired The calibration exceeded the full interval or the adjustment

interval.
No Cal This status is displayed only on the Current tab of the

Calibration Status screen when one of the following situations
occurs:
• A calibration has not been run for the reagent lot, or the
reagent lot and cartridge combination, that is loaded on
the system.
• One or more c‑series assay parameters were edited.
• The c‑series parameter that designates whether to
calibrate an assay by lot or cartridge was edited.
• One or more calibrator concentration values were edited.
Pending QC The system is configured to require quality control to run after

a calibration is generated. The calibration was completed
successfully and no control level has completed.
Overridden The operator has manually overridden an expired calibration.
Overridden Lot The system is configured to track the calibrator lot expiration
date and the operator has manually overridden an expired
calibrator lot.

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In Process This status is displayed only on the Current tab of the

Calibration Status screen and indicates that a calibration
order is in process.
Active The calibration completed successfully and is not expired.
Inactive This status is displayed only on the Historical tab of the

Calibration Status screen when one of the following situations
occurs:
• A previously active calibration is replaced by a more
recent calibration.
• The number of supported active calibrations for a specific
processing module, assay, and reagent lot or reagent lot
and cartridge combination has been exceeded. The
oldest active calibration becomes inactive.
Calibration Status screen, Search flyout element descriptions, page 798
View the assay calibration status

Perform this procedure to view the calibration status of an assay before sample processing is
initiated or when a status indicator is displayed.
NOTE: When no active calibration is stored, tests that are initiated become exceptions and are
not processed.
modules.
2. To display the data for one module, tap a Module button.
3. In the Status column, view the calibration statuses.

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Transmit a calibration to the host

Perform this procedure to transmit calibration information to the host. To transmit calibration
information to the host, the following conditions must be met:
• On the Host Setup screen, the Host Interface option must be configured for HL7.
• Under Transmission Options on the Host Setup screen, the Calibration option must be
configured for On.
• The calibration status is active.
• The calibration result transmission status is not Pending Transmission.

2. On the Current tab of the Calibration Status screen, tap one or more calibrations to transmit
NOTE: To filter the list, tap a Module button or tap Search.
3. Tap Transmit.
Fail a calibration
Required instrument • Processing module: Stopped, Warming, or Idle
status
• Reagent and sample manager: Stopped or Idle
Perform this procedure to fail a calibration that has a status of Active or Pending QC and to
prevent subsequent result generation from the calibration for existing control and specimen
orders.
NOTE: The procedure cannot be performed on assays with calibration methods of Use Cal
Factor Blank (c‑series) and Reference (i‑series). The procedure can be performed from the
Historical tab of the Calibration Status screen.
modules.
2. To display the data for one module, tap a Module button.
3. Tap one or more assays.
4. Tap Details.

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5. On the Calibration Status Details screen, tap Fail for the selected calibration.
7. If more than one calibration was selected, tap Next to go to each calibration, and then
repeat steps 5, page 807 and 6, page 807 for each calibration.
8. To return to the Calibration Status screen, tap Done.
After a calibration is failed, if a new assay calibration is ordered and specimen and control tests
are included, and the new assay calibration fails, the specimen and control tests become
exceptions.
Active calibration storage, page 793

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NOTES

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Section 7 Operational precautions and limitations
Introduction
For optimal operator safety and accurate test results, comply with operational requirements,
precautions, and limitations. Failure to comply can affect system performance, and may cause
damage to the system or may adversely affect test results.
Precautions and requirements for system operation, page 811
Requirements for handling the consumables, page 812
Limitations of result interpretation, page 816
Operator responsibility, page 818

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Operational precautions and limitations
General requirements Section 7
General requirements
For optimal system performance, comply with the following general requirements of the system:
• Contact an Abbott Laboratories representative to install or relocate the system.
• Do not install the system near direct sunlight, heat, drafts, and heat-generating devices.
Exposure to heat and drafts can interfere with the system's ability to maintain an acceptable
operating temperature.
• Maintain the required space on all sides of the system. This space buffer is essential for the
following conditions:
– Adequate cooling of electrical components
– Accurate temperature control of the system
– Access for maintenance
– Access to disconnect the power cord when required
• Leave on the system power at all times unless instructed otherwise for a maintenance
procedure or a troubleshooting procedure, or unless an emergency situation occurs.
• Perform maintenance procedures as recommended later in this manual.
• Do not attempt any maintenance or repairs that are not specified in documentation provided
by Abbott Laboratories.
Operational precautions and limitations, page 809
Service, maintenance, and diagnostics, page 837
System clearances, page 455

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Section 7 Precautions and requirements for system operation
Precautions and requirements for system

operation
When operating the system, comply with the precautions and requirements for system operation.
Failure to comply may cause damage to the system or may adversely affect test results.
Precautions and requirements before operation, page 811
Precautions during operation, page 811
Precautions and requirements before operation

Before operating the system, comply with the following precautions and requirements:
• Thoroughly read this manual to become familiar with the system functionality and associated
hazards.
• Read the sections of the product documentation that contain the following information:
– Warnings and general precautions
– Safety precautions
– Precautions for handling
• Verify that adequate supplies and reagents are loaded on the system.
Precautions during operation

While operating the system, comply with the following precautions:
• Close all system doors and covers unless instructed otherwise for a maintenance procedure
or a troubleshooting procedure.
• Do not disconnect any electrical connection during normal system operation.
• Respond to system notifications that relate to waste levels during system processing.
Dispose of all waste in accordance with local, state, and national regulations.
• Do not replace any fuses. Fuses are not replaceable by the operator.

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Requirements for handling the consumables Section 7
Requirements for handling the consumables

For optimal operator safety and accurate test results, comply with the requirements for handling
the consumables.
For more information about handling the consumables, see the following documentation:
• Product package inserts
• Specific product labels
• Safety Data Sheets
Requirements for storage, page 812
Requirements for use, page 812
Requirements for storage

When storing reaction vessels, reagent cartridges, reagent replacement caps, and sample cups,
comply with the following requirements:
• Keep all consumables clean and dust-free.
• Store all consumables in their original containers so that information such as expiration
dates and lot numbers is available if necessary.
When storing reagents, calibrators, controls, and bulk solutions, comply with the following
requirements:
• Store reagents, calibrators, controls, and bulk solutions as instructed on their labels or in the
product documentation.
• Store reagents in an upright position. For more information, see the product documentation.
If reagents, calibrators, controls, or bulk solutions are received in a condition that is contrary to
the label recommendation or the product documentation, or are damaged, contact the local
representative or find country-specific contact information at abbottdiagnostics.com.
Requirements for use

When using reaction vessels (RVs), reagent cartridges, reagent replacement caps, and sample
cups, comply with the following requirements:

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Section 7 Requirements for handling the consumables
• Do not reuse or substitute consumables. Abbott Laboratories cannot accept responsibility for
system performance and test results when consumables are reused or have been
manufactured by anyone other than Abbott Laboratories.
• Use caution to prevent contamination and operator exposure when handling the RVs,
reagent replacement caps, and sample cups.
• Consider all used RVs, reagent cartridges, reagent replacement caps, and sample cups as
potentially infectious. Follow appropriate procedures for handling the consumables.
When using reagents, calibrators, controls, and bulk solutions, comply with the following
requirements:
• Do not substitute materials. Abbott Laboratories manufactures substances and components
according to quality standards that are controlled rigidly. Substitution of materials may
adversely affect system performance, test results, safety, and equipment life.
• Do not excessively mix or shake liquids, minimizing the formation of foam and bubbles.
• Do not pipette by mouth.
• Do not smoke, eat, drink, apply cosmetics, or handle contact lenses in areas where
specimens, reagents, calibrators, controls, or bulk solutions are handled.
• Consider all reagents, calibrators, and controls that contain human-sourced materials as
potentially infectious.
• Use caution to prevent contamination and operator exposure when handling the reagents,
calibrators, controls, and bulk solutions.
• Wear clean gloves to prevent contamination and operator exposure when placing reagent
cartridges on the system.
• Do not invert used reagent cartridges since this action causes reagent leakage and may
compromise test results.
• Verify that reagent cartridges are within the expiration date before loading them on the
system.
• Do not use reagents, calibrators, controls, and bulk solutions beyond their expiration dates.
• Do not use reagents on the system beyond the maximum number of cumulative days. For
more information, see the product documentation.
• Verify that bulk solutions are loaded in the appropriate position to ensure that test results
are not adversely affected.
• Do not mix reagents, calibrators, controls, and bulk solutions within a lot or between lots.

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Requirements for handling the specimens Section 7
Requirements for handling the specimens

For information about specimen collection, preparation, and storage, see the product
documentation. Consider all specimens as potentially infectious. In addition, consider all system
surfaces or components that have come in contact with specimens as potentially infectious.
Requirements for collection
When collecting specimens, comply with the following requirements:

• Comply with all precautions for blood collection by venipuncture to prevent specimen
hemolysis.
• Verify that the correct specimen type is used. The system does not verify the specimen
type.
Requirements for preparation and storage
When preparing and storing specimens, comply with the following requirements:
• Inspect all specimens for bubbles. Remove bubbles with a clean applicator stick before
performing sample processing. Use a new applicator stick for each specimen to prevent
cross contamination.
• Verify that serum and plasma specimens do not contain fibrin, red blood cells, or other
particulate matter.
• For sample volume information, see the product documentation.
• Separate serum specimens or plasma specimens from clots, serum separators, or red blood
cells before freezing the specimens.
• Mix and centrifuge serum specimens or plasma specimens after any freeze-thaw cycle or to
remove red blood cells or other particulate matter. For information about limitations and
interfering substances, see the product documentation.
• Avoid multiple freeze-thaw cycles. After thawing a specimen, thoroughly mix it at a low
speed or gently invert it. Mixed specimens produce consistent test results.
• Remove closures from specimen tubes before loading the tubes on the reagent and sample
manager.
• After loading samples on the system, process the samples within the number of hours
specified in the product documentation to minimize evaporation effects.

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Section 7 Requirements for handling the specimens

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Limitations of result interpretation Section 7
Limitations of result interpretation

Test results must be used with other clinical data, such as symptoms, other test results, the
patient history, clinical impressions, the clinical evaluation information, and other diagnostic
procedures. Consider all data for patient care management.
If test results are inconsistent with the clinical evidence, additional testing is recommended to
confirm the results.
Errors can occur because of potential operator errors and system technology limitations.

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Section 8 Hazards
Introduction
To minimize the potential for harm to personnel and damage to the laboratory environment,
comply with the hazard and safety information.
This section contains supplemental information. Do not use the supplemental information to
supersede workplace safety requirements. Review any significant differences between the
supplemental information and the workplace safety requirements with management or a
workplace safety representative.
Operator responsibility, page 818
Safety icons, page 819
Spill cleanup, page 828
Physical hazards, page 835

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Hazards
Operator responsibility Section 8
Operator responsibility
Use the system only according to its designed purpose. Operators must be trained before
operating the system. Failure to comply with safe-use instructions may cause personal injury,
harm the environment, damage the system, or adversely affect test results.
Any tool use to override interlocks must be controlled and distributed by the operator or the
operator's management.
Hazards, page 817

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Hazards
Section 8 Safety icons
Safety icons
Safety icons are used on the system and in the system documentation to identify potentially
dangerous conditions. Become familiar with these icons to know the type of potential hazard.
Table 44: Safety icons and descriptions
Icon Description
CAUTION: Biological RISKS
Identifies an activity or an area where you may be exposed to potentially infectious
material.
CAUTION: Possibility of electric shock

Indicates the possibility of electric shock if procedural controls or engineering
controls are not observed.
CAUTION: Hot Surface
Identifies an activity or an area where you may be exposed to hot surfaces.
CAUTION: Probe Stick Hazard

Identifies an activity or an area where you may be exposed to probes.
CAUTION
When used in this manual, this icon is accompanied by a description of the hazard
and a related-information reference to safety content in this section. Examples
include the following conditions:
• CAUTION: Lifting Hazard
Identifies an activity where you may be required to lift or move a heavy object.
• CAUTION: Moving Parts
Identifies an activity or an area where you may be exposed to moving parts.
• CAUTION: Chemical Hazard
Identifies an activity or an area where you may be exposed to hazardous
chemicals.
CAUTION: Disconnect Mains Plug
Identifies a main electrical disconnect.
Electrical and electronic equipment waste

Indicates that the item needs to be disposed of in a separate waste collection for
electrical and electronic equipment and must not be disposed of in the general
waste or trash.
Hazards, page 817

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Hazards
Safety icons Section 8
Probes and other sharps, page 835

Heavy objects, page 835
Hot objects, page 836

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Hazards
Section 8 Biological hazards
Biological hazards
Exposure to potentially infectious materials may occur when the following activities are
performed:
• Handling of specimens, reagents, calibrators, and controls
• Spill cleanup
• Waste handling and disposal
• System relocation
• Maintenance procedures
• Decontamination procedures
• Component replacement procedures
Comply with the precautions to help minimize the impact of this exposure.
Hazards, page 817
Precautions, page 821
Component replacement, page 920
Precautions
Consider as potentially infectious all products that are derived from human-sourced materials
and all system surfaces and components that have come in contact with human-sourced
materials. No known test method can offer complete assurance that products derived from
human-sourced materials do not transmit infection.
It is recommended that all potentially infectious materials are handled according to the OSHA
Standard on Bloodborne Pathogens1. Use Biosafety Level 22 or appropriate biosafety
practices3,4 for materials that contain or are suspected to contain infectious agents. Precautions
include the following actions:
• When handling human-sourced materials or contaminated system components:
– Wear gloves, a lab coat, and protective eyewear.
– Do not eat, drink, smoke, apply cosmetics, or handle contact lenses.
• Do not pipette by mouth.

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Hazards
Biological hazards Section 8
• Clean spills of potentially infectious materials and contaminated system components with a
quaternary ammonium detergent. Then mist or wipe the surface with 0.5% sodium
hypochlorite solution. Let the disinfectant remain on the surface for a minimum of 10
minutes of contact time.
• Decontaminate and dispose of all samples, reagents, and other potentially contaminated
materials in accordance with local, state, and national regulations.
Immediately clean an affected area if any exposure to biohazardous or potentially infectious

materials occurs:
Eyes Rinse with water for 15 minutes.
Mouth Rinse with water.
Skin Wash the affected area with soap and water. Apply alcohol,
povidone iodine, chlorhexidine, or another antiseptic.
Puncture wound Let the wound bleed freely. Wash the affected area with soap
and water.
Seek medical attention as soon as possible for appropriate follow-up.
Bibliography references
1. US Department of Labor, Occupational Safety and Health Administration, 29 CFR Part

1910.1030, Bloodborne pathogens.
2. US Department of Health and Human Services. Biosafety in Microbiological and Biomedical
Laboratories. 5th ed. Washington, DC: US Government Printing Office; December 2009.
3. World Health Organization. Laboratory Biosafety Manual. 3rd ed. Geneva: World Health
Organization; 2004.
4. Clinical and Laboratory Standards Institute (CLSI). Protection of Laboratory Workers From
Occupationally Acquired Infections; Approved Guideline--Fourth Edition. CLSI Document
M29-A4. Wayne, PA: CLSI; 2014.

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Hazards
Section 8 Chemical hazards
Chemical hazards
Exposure to hazardous chemicals may occur when consumables are handled.
To minimize any exposure to hazardous chemicals, follow the instructions provided in the
following documentation:
• Product package inserts
• Specific product labels
• Safety Data Sheets (SDSs)
When the Alinity ci‑series is installed and is used correctly, system design features further
reduce exposure levels.
System products are classified and labeled in accordance with the Globally Harmonized System
of Classification and Labelling of Chemicals (GHS) as implemented in regional regulations.
Examples of regional regulations include the U.S. OSHA Hazard Communication Standard (HCS)
and the European Regulation (EC) 1272/2008 on classification, labelling, and packaging of
substances and mixtures (CLP).
Pictograms (red-bordered diamonds), signal words (such as Warning and Danger), hazard
statements (H), and precautionary statements (P) are included on respective product labeling.
Other country-specific warnings and precautions may also be included on product labeling.
For SDSs, contact the local representative or find country-specific contact information at
abbottdiagnostics.com.
Hazards, page 817
General precautions, page 823
Sodium azide, page 824
Sensitizers, page 825
Dry ice, page 825
General precautions
In general, comply with the following precautions when handling chemicals:
• Consult the Safety Data Sheets for safe-use instructions and precautions.
• Avoid contact with skin and eyes. If contact with material is anticipated, wear impervious
gloves and protective clothing and eyewear.
• Maintain good housekeeping. Do not eat, drink, or store food and beverages in areas where
chemicals are used.

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Hazards
Chemical hazards Section 8
• Immediately clean spilled fluids.

• Seek medical attention if irritation or signs of toxicity occur after exposure.
CAUTION: This product contains chemicals known to the state of California to
cause cancer and birth defects or other reproductive harm.
• For information related to Article 33 of the EU REACH regulation (EC 1907/2006,

Registration, Evaluation, Authorisation, and Restriction of Chemicals), go to pmis.abbott.com.
For website logon issues, contact Abbott Laboratories at abbott.REACH@abbott.com.
• To view the China RoHS 2 Hazardous Substance tables, in accordance with the People’s
Republic of China Electronic Industry Standard SJ/T 11364-2014, go to
abbottdiagnostics.com/registration-ous (select Technical Library > Other Reference
Documents > China RoHS Hazardous Substance Tables).
Sodium azide
Some products contain sodium azide. Comply with the following precautions when using
products or handling waste that contains sodium azide:
• Do not use any chemical or product with a pH below 6 to disinfect waste that contains
sodium azide. Hydrazoic acid, a highly toxic gas, is released when the pH is lower than 6.
Normal operation of the system uses small amounts of sodium azide with other reagent
components and does not generate hydrazoic acid at levels that are harmful to the operator.
• Thoroughly flush drains with water several times each day to prevent the formation of
potentially explosive metal azides on lead components, copper components, brass
components, or the solder in laboratory plumbing if product waste or instrument waste is
released to a drain. More information about azides in laboratory drains is available in
Current Intelligence Bulletin No.13: Explosive Azide Hazard (August 16, 1976), a publication
issued by the U.S. National Institute for Occupational Safety and Health (NIOSH). For a copy
of this bulletin, contact the local representative or go to one of the following websites:
– cdc.gov/niosh
Search for the bulletin title.
– abbottdiagnostics.com
Go to the international website or the U.S. website. Select Support/Technical Library/
Other Reference Documents.

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Hazards
Section 8 Chemical hazards
Sensitizers
Some products contain low levels of ingredients that are reported to be sensitizers. Sensitizers
can stimulate allergic reactions in some people. The allergic reactions may occur with the first
exposure or only after repeated exposures. Methylisothiazolones, which are used as
preservatives in some products, have been associated with the stimulation of allergic skin
reactions (allergic contact dermatitis). Certain enzymatic cleansers may stimulate allergic
reactions in the respiratory systems of people who are sensitive to the ingredients.
To reduce the potential for exposure to sensitizers, comply with the following precautions:
• Use good laboratory techniques to minimize spatters, spills, and other aerosolization of
liquids and powders, particularly when pouring or transferring materials.
• Wear impervious gloves and other personal protective equipment that is appropriate for
biomedical laboratories.
• Immediately remove gloves if they are damaged or contaminated.
• Wash hands after removing gloves and immediately before putting on a fresh pair of gloves.
• Handle containers at a comfortable height that is below chest level.
Dry ice
Some products are shipped on dry ice. Dry ice is solid carbon dioxide and is cryogenic at a
temperature of -78.5°C. Wear appropriate personal protective equipment such as cold-insulating
gloves and ensure appropriate ventilation when handling the dry ice.
If unprotected skin comes in contact with dry ice for an extended period of time, skin cells may
freeze and produce a freeze burn. Symptoms of a freeze burn are redness, blisters, and peeling
skin. Symptoms can vary based on the duration of exposure.
Solid carbon dioxide transitions into a gaseous state through a process known as sublimation.
Carbon dioxide is a colorless, odorless gas that is approximately 1.5 times heavier than air and
therefore flows downward. In closed, unventilated areas, carbon dioxide is displaced from the air
and accumulates on the floor in increased concentrations as a "carbon dioxide lake." Ambient
indoor air in areas with adequate ventilation contains approximately 0.03% carbon dioxide by
volume.
Inhalation of air with 3% to 5% carbon dioxide by volume causes headaches, respiratory
disorders, and malaise. Inhalation of air with 8% to 10% carbon dioxide by volume may cause
cramps, fainting, respiratory arrest, and death.

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Hazards
Waste handling and disposal Section 8
Waste handling and disposal

Each facility has the responsibility to label all waste containers and to characterize its waste
stream to confirm that waste is disposed of in accordance with local, state, and national
regulations.
Hazards, page 817
Liquid wastes that contain (potentially) infectious materials, page 826
Batteries, page 827
Remove the RV waste and update the inventory (i‑series), page 584
Liquid wastes that contain (potentially) infectious materials

To meet institutional or local requirements for the decontamination or disinfection of liquid
wastes that contain infectious or potentially infectious materials, consider the following
precautions:
• Select a disinfectant that is effective against bloodborne infectious agents and against other
microbial agents that may be prevalent in the local population. A disinfectant that is effective
against Mycobacterium tuberculosis generally is effective against all known viruses and non-
spore-forming bacteria and is suitable for most clinical laboratory situations.
• Select a disinfectant and a method that do not bubble, effervesce, or generate aerosols.
• Do not use any chemical or product with a pH below 6. The use of materials with a pH
below 6 generates highly toxic hydrazoic acid gas if wastes from the materials contain
sodium azide.
• Do not use any chemical or product for disinfection that contains any metal. This precaution
prevents the creation of highly explosive metal azides in wastes that may contain sodium
azide.
• Obtain and review the manufacturer's safety information before using any disinfectant.
• Use disinfectants according to the manufacturer's directions (for example, do not use
excess disinfectant). Failure to follow the manufacturer's directions may cause unexpected
effects.
• Do not use a disinfectant if the facility, the equipment, and other protective measures are
not appropriate for safe use with the disinfectant.
• Autoclaving is not recommended for materials contaminated with products that contain
chemicals that are hazardous by inhalation at low concentrations (for example, cyanides).
• Wear appropriate personal protective equipment (such as gloves, a lab coat, and eyewear)
when performing decontamination activities.

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Hazards
Section 8 Waste handling and disposal
Batteries
The European Battery Directive requires separate collection of spent batteries to facilitate
recycling and protect the environment.
The system contains batteries that are not intended for the operator to service or remove. Only
an Abbott Laboratories representative or a qualified individual may remove the batteries in the
system at the end of the life of the system and may dispose of them in accordance with local
regulations for separate collection of spent batteries.
Contact the local representative or find country-specific contact information at

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Hazards
Spill cleanup Section 8
Spill cleanup
Clean spills according to established biosafety practices and follow instructions in the Safety
Data Sheets. In general, safe work practices for spill cleanup include the following requirements:
1. Wear appropriate personal protective equipment, such as gloves, a lab coat, and eyewear.
2. Absorb the spill with an absorbent material.
3. Wipe the spill area with a quaternary ammonium detergent.
4. Mist or wipe the spill area with 0.5% sodium hypochlorite solution. Let the disinfectant
remain on the surface for a minimum of 10 minutes of contact time.
5. Dispose of all absorbent material and wipes according to local, state, and national
regulations.
Hazards, page 817
Unscheduled cleaning, page 873

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Hazards
Section 8 Requirements for decontamination
Requirements for decontamination

Sodium hypochlorite and other disinfectants are typically hazardous chemicals that react with
many chemicals, materials, and living tissues. To reduce the potential for exposure to
disinfectants, comply with the following general precautions:
• Obtain and review the manufacturer's safety information before using any disinfectant.
• Wear appropriate personal protective equipment (such as gloves, a lab coat, and eyewear)
when performing decontamination activities.
Hazards, page 817
Preparation of sodium hypochlorite solutions, page 829
Sodium hypochlorite stability, page 830
System relocation, page 167
Clean and decontaminate external components, page 873
Clean and decontaminate the bar code scanner, page 874
Preparation of sodium hypochlorite solutions

To calculate the number of parts of water required to mix with one part of manufacturer-supplied
sodium hypochlorite solution, use the following equation:
B − A
X = A
Where:
A Percent of sodium hypochlorite solution that is wanted
B Percent of sodium hypochlorite (active or available chlorine)

in manufacturer-supplied sodium hypochlorite solution
X Number of parts of water required to mix with one part of

manufacturer-supplied sodium hypochlorite (active or
available chlorine) solution
Example:
A = 0.5%
B = 5%

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Hazards
Requirements for decontamination Section 8
5% − 0.5%
X = 0.5%
= 9
Mix one part of sodium hypochlorite with nine parts of water.

To calculate the volume of sodium hypochlorite required to make a specific volume of sodium
hypochlorite solution, use the following equation:
A × V2
V1 = B
Where:
A Percent of sodium hypochlorite solution that is wanted
B Percent of sodium hypochlorite (active or available chlorine)

in manufacturer-supplied sodium hypochlorite solution
V1 Volume of manufacturer-supplied sodium hypochlorite solution
V2 Total volume that is wanted
Example:
A = 0.5%
B = 5%
V2 = 1000 mL (1 L)
0.5% × 1000 mL
V1 = 5%
= 100 mL
Mix 100 mL of manufacturer-supplied sodium hypochlorite solution with 900 mL of water to make
1 L of sodium hypochlorite solution.
Sodium hypochlorite stability

Use a freshly prepared solution of sodium hypochlorite for decontamination. Sodium hypochlorite
needs to be prepared fresh daily to ensure that the solution contains a sufficient quantity of
active compound (for example, chlorine) to be effective. The amount of active chlorine in sodium
hypochlorite solutions, for example, is reduced by the following factors:
• The presence of organic matter in the water used for dilution
• The temperature at which the solution is stored
• The type and size of the container and closure
• The frequency and nature of use

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Hazards
Section 8 Requirements for decontamination
If a facility has data that demonstrates a longer shelf-life is valid under the specific conditions of
solution preparation and storage in the facility, prepare solutions in advance and store them.

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Hazards
Electrical hazards Section 8
Electrical hazards
The system does not pose uncommon electrical hazards to operators if it is installed and is
operated without alteration, and if it is connected to a power source that meets the required
specifications.
Basic electrical hazard awareness is essential to the safe operation of the system. Only qualified
personnel may perform electrical servicing.
Elements of electrical safety include the following requirements:
• Inspect cables that connect to the system for signs of wear and damage.
• Use only approved power cords and electrical accessories, such as the cords and
accessories that are supplied with the system, to protect against electric shock.
• Use an appropriately grounded electrical outlet of correct voltage and current-handling
capability.
• Do not disconnect any electrical connections or service any electrical and internal
components while the system power is on.
• Keep liquids away from all connectors of electrical and communication components.
• Do not touch any switches or outlets with wet hands.
• Keep the floor dry and clean under and near the system.
• Use a ground fault circuit interrupter when working in a wet environment.
• Immediately clean liquid spills. Turn off the system power and disconnect the system power
cord before cleaning major liquid spills.
Hazards, page 817

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Hazards
Section 8 Mechanical hazards
Mechanical hazards
The Alinity ci‑series is an automated system that operates by computer control. As with most
automated equipment, the potential for injury and bodily harm from moving mechanical
components is present when system operation occurs.
To minimize mechanical hazards, the system provides guards to protect against accidental
contact with moving components and incorporates safety features in the hardware.
The system requires the operator to accurately position all specimens, reagents, calibrators,
controls, sample cups, and tubes on the system. Be sure to correctly position sample cups,
tubes, and reagent cartridges before any operation is initiated.
Although the system is equipped with safety features to stop the lowering of probes, do not
reach into the processing center during system operation. To interrupt a run, follow the operating
instructions in this manual.
The top of the RSM transport is equipped with white light-emitting diodes (LEDs) as visual safety
indicators. The LEDs provide visibility to the RSM transport position and movement at all times.
Do not reach into the path of the RSM transport at any time. Do not run the system unless at
least one LED is illuminated. If neither LED is illuminated, contact Customer Service to resolve
the failure.
If necessary for maintenance and diagnostic procedures, interlocks can be overridden by an
Abbott Laboratories representative or trained operators only by using the procedure key. Be
aware that potential mechanical hazards and Biological RISK may be present. Be aware of
moving parts. Do not reach into the paths of moving parts.
During system operation, the operator may be exposed to the following moving components:
• Pipettors and probes
• Sample transport
• RV loader assembly
• Wash aspiration probes
• Processing center
• Processing module pumps
Elements of mechanical safety include the following requirements:

• Keep all protective covers and barriers in the appropriate positions.
• Do not perform manual tasks on the work surface of the system.
• Do not insert any parts of the body into an area of mechanical movement during system
operation.
• Do not wear articles of clothing or accessories that can catch on the system.
• Empty pockets of items that can fall into the system.

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Hazards
Mechanical hazards Section 8
• Be aware that reflex actions can occur and cause injury in the event of a system
malfunction or an unexpected sequence of movements.
• Use caution when performing procedures for adjustment, maintenance, cleaning, and repair.
• Use caution when loading sample racks or sample trays.
• Use caution when loading reagent cartridges.
• Use caution when moving full waste containers.
Hazards, page 817

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Hazards
Section 8 Physical hazards
Physical hazards
Use safe practices to avoid injury when any exposure to potential physical hazards occurs.
Hazards, page 817
Probes and other sharps, page 835
Heavy objects, page 835
Hot objects, page 836
Tripping hazards, page 836
Probes and other sharps

Probes are sharp and may be contaminated with infectious material. Avoid contact with tips of
probes. Although the system is equipped with safety features to stop the lowering of probes, do
not reach into the processing center during system operation.
In general, minimize the use of sharps and glassware. Use mechanical means to remove
contaminated, broken glassware. Dispose of sharps in an appropriately labeled, puncture-
resistant, leakproof container before treatment and disposal.
Heavy objects
The system is a heavy instrument. Confirm that adequate help is available before relocating the
system. For information about the relocation of the system, contact an Abbott Laboratories
representative.
Obtain adequate help or use mechanical devices to move or lift heavy items.
Use the following techniques to help reduce the risk of injury when lifting objects:
• Keep the head up and the back straight. Bend at the hips and knees.
• Bring the load as near to the body as possible and keep the load directly in front of the
body.
• Tighten the abdominal muscles, push the feet down into the ground, and straighten the
knees (that is, lift with the legs, not with the back).
• Do not twist and reach to the side or twist and lift. Instead, move the feet to turn the body.
• Bend at the knees by using only the leg muscles and place the load in the appropriate
location.

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Hazards
Physical hazards Section 8
• Try to perform lifts at waist height with the elbows near the body.
Hot objects
The lamp and the lamp housing may be hot. Before replacing the lamp, power off the c‑series
processing module. Wait a minimum of 5 minutes so that the lamp and the lamp housing can
cool. Wear gloves if necessary.
Tripping hazards
The Alinity ci‑series is equipped with a power cord for each processing module, several
computer cables, and water and waste tubing for the system control module. To avoid a tripping
hazard, ensure that the cords, cables, and tubing in high-traffic areas are routed safely.

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Section 9 Service, maintenance, and diagnostics
Introduction
The appropriate service, maintenance, and diagnostics of the system are some of the most
important aspects of a complete quality assurance program. A thorough service, maintenance,
and diagnostic program:
• Minimizes downtime.
• Maintains records for inspection and accreditation.
• Maintains system performance to provide optimal test results.
Maintenance and diagnostics, page 838
Troubleshooting, page 1023

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Service, maintenance, and diagnostics
Maintenance and diagnostics Section 9
Maintenance and diagnostics

The system software provides a user-friendly interface to perform and track maintenance and
diagnostic activities.
The Procedures screen displays maintenance and diagnostic procedures that can be performed.
After initiating a procedure, follow step-by-step instructions through the procedure to completion.
The online log indicates the date and time that the procedure is completed. The performance of
the procedure is tracked in the online log.
If a maintenance procedure or a diagnostic procedure requires the cover interlocks to be
overridden by using the procedure key, the interlocks can be overridden only by trained
operators. Be aware that potential mechanical hazards and Biological RISK may be present. Be
aware of moving parts. Do not reach into the paths of moving parts.
Procedures screen, page 838
Procedures Log screen, page 851
Descriptions of maintenance and diagnostic procedure statuses, page 856
Maintenance procedure descriptions, page 857
Diagnostic procedure descriptions, page 875
Procedures screen
On the Procedures screen, the operator can view the following information:
• Scheduled maintenance procedures to perform by category
• Available diagnostic procedures to perform by category
• In-process maintenance procedures or in-process diagnostic procedures
A trained operator can perform the following functions:

• Access details for a maintenance procedure or a diagnostic procedure.
• Perform a maintenance procedure or a diagnostic procedure.
• Print a maintenance procedure or a diagnostic procedure.
• Access maintenance logs or diagnostic logs.
Procedures screen element descriptions, page 839
Version Details for Procedure flyout element descriptions, page 841

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Section 9 Maintenance and diagnostics
Perform Procedure screen, page 843

Perform Procedure screen element descriptions, page 843
Show Video flyout element descriptions, page 844
Show Picture flyout element descriptions, page 845
Descriptions of procedure key settings, page 845
Perform a maintenance procedure or a diagnostic procedure, page 849
Return to a maintenance procedure or a diagnostic procedure in process, page 851
Procedures screen element descriptions
Maintenance tab, Diagnostics tab

The Maintenance tab displays maintenance procedures that can be performed for a selected
module. The Diagnostics tab displays diagnostic procedures that can be performed for a
selected module. Maintenance and diagnostic procedures are grouped by categories. Category
tabs are displayed on the right side of the Procedures screen.
Elements
Module bar Used to select an individual module to perform maintenance

or diagnostic procedures.
maintenance or diagnostic procedure is in process and
A red badge is displayed on the module number when one or
more maintenance procedures are overdue.
Procedure Displays a list of the procedures that can be performed for

the selected module. The procedures are grouped by
categories. The Minus button next to each category
collapses the list of procedures associated with the category.
The Plus button next to each category expands the list of
procedures associated with the category.
Last Performed Displays the date and time that the procedure was last
performed.
Operator ID Displays the operator ID that is logged onto the system when
the procedure was performed.
Category tabs The following categories are displayed for maintenance

procedures if applicable:

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• All
• To Do
• Daily
• Weekly
• Monthly
• Quarterly
• Triannual
• Semiyearly
• Yearly
• As Needed
The following categories are displayed for diagnostic

procedures:
• All
• Optics
• Pipettors
• Fluidics-Wash
• Temperature
• RV Loader (only for i‑series)
• Process Path (only for i‑series)
• Sample Manager
• Reagent Manager
• Modules
• Utilities
• Reaction Mechanisms (only for c‑series)
• ICT (only for c‑series)
Function buttons
Log button Navigates to the Procedures Log screen.
Details Displays the Version Details for Procedure flyout.

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Perform Navigates to the Perform Procedure screen.
In Process tab
The In Process tab displays the maintenance or diagnostic procedure that is in process for a
selected module.
Elements
Module bar Used to select an individual module to view the status of a

procedure that is in process.
maintenance or diagnostic procedure is in process and
Procedure Displays the procedure that is in process for the selected

module.
Status Displays the status of the maintenance or diagnostic

procedure.
Time Started Displays the date and time that the procedure was started.
Function button
Continue Navigates to the Perform Procedure screen of the

maintenance or diagnostic procedure that is in process.
Version Details for Procedure flyout element descriptions

The Version Details for Procedure flyout provides the version details of the selected
maintenance or diagnostic procedure.
Procedure Details area
Procedure Displays the number and name of the selected procedure.
Description Provides a short description of the selected procedure.

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Current Version Displays the current version of the selected procedure.
Category Displays the category of the selected procedure.
Status to Perform Displays the instrument status of the processing module that
Procedure is necessary to perform the selected procedure.
Operator Access Level Displays the operator access level that is necessary to
perform the selected procedure.
Procedure Key Setting Displays the procedure key setting that is necessary to
perform the selected procedure.
Last Performed Details area
Version Displays the version of the selected procedure when the

procedure was last performed. If the procedure has not been
performed, the element is blank.
Completion Date Displays the date and time that the selected procedure was
last performed. If the procedure has not been performed, the
element is blank.

system when the selected procedure was performed. If the
procedure has not been performed, the element is blank.
Completion Status Displays the last status of the selected procedure. If the
procedure has not been performed, the element is blank.
Function buttons



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Perform Procedure screen

On the Perform Procedure screen, the operator can view the following information for a
procedure in process:
• Procedure category and name
• Procedure status
• Procedure description

• Continue the procedure.
• Close the screen to perform a procedure on another module.
• Access other screens.
• Quit the procedure.
Perform Procedure screen element descriptions

Displays information about the procedure and step-by-step instructions for performing the
procedure.
Elements
Type Displays the type of procedure being performed:

• Maintenance
• Diagnostic
Category Displays the maintenance or diagnostic category for the

procedure.
Procedure Displays the procedure number and name.
Status Displays the status of the maintenance or diagnostic

procedure.
Instructions Displays step-by-step instructions to perform the maintenance

or diagnostic procedure.
User Input Displays the buttons and fields to continue the procedure or
provide user input.

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Activity Displays the activity of the module while performing the

procedure.
Results Displays the results of the procedure.
Function buttons
Show Video Displays the Show Video flyout.
Show Picture Displays the Show Picture flyout.

Quit Cancels selections or entries and displays the Done button to

exit the procedure.
Show Video flyout element descriptions

In the Show Video flyout, the operator can play a video that is specific for the maintenance or
diagnostic procedure being performed.
Element
Close button Closes the flyout.
Function buttons
Video slider Advances and rewinds the video.
Play button Starts the video.
Pause button Pauses the video.
Stop button Stops the video.

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Audio button Audio is currently unavailable for the maintenance and

diagnostic videos.
Volume slider Audio is currently unavailable for the maintenance and

diagnostic videos.

Show Picture flyout element descriptions

In the Show Picture flyout, the operator can display a picture that is specific for the maintenance
or diagnostic procedure being performed.
Element
Close button Closes the flyout.
Function button

Descriptions of procedure key settings

The procedure key provides access to the front and rear processing center covers of the
Alinity ci‑series processing modules and the reagent and sample manager (RSM) when
maintenance procedures, diagnostic procedures, and component replacement procedures are in
process. The procedure documentation includes the procedure key settings.
NOTE: For procedures that require a processing module and the RSM, the procedure keys for
the processing module and the system control module (SCM) need to be positioned at the
designated procedure key settings.
The following list provides descriptions of the procedure key settings:
Off The setting is indicated by the black dot on the procedure

lock. To perform a procedure, the procedure key is not
required to be inserted into the procedure lock.

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Required On The setting is indicated by the white dot on the procedure

lock. To perform a procedure, the procedure key must be
inserted into the procedure lock and must be positioned at the
On setting.
Optional On The procedure key is or is not inserted into the procedure

lock. If the procedure key is inserted, the key can be
positioned at the setting for On or Off. However, access to the
front and rear processing center covers is permitted only
when the procedure key is inserted and is positioned at the
On setting. If the front or rear processing center cover is lifted
during the procedure when the procedure key is positioned at
the Off setting or when the key is not inserted, the instrument
statuses of the processing module and the RSM transition to
Stopped and power is removed from the following module
components:
• c‑series: Sample pipettor
• i‑series: Sample, R1, and R2 pipettors
• RSM: RSM transport
Use a procedure key to perform a procedure

status
Perform this procedure to adjust the procedure key setting on the Alinity c processing module,
the Alinity i processing module, and the system control module (SCM). A procedure key is
provided for use with a maintenance procedure, a diagnostic procedure, or a component
replacement procedure. To determine the procedure key setting for a specific procedure, see
the procedure documentation.
When the processing module procedure key is positioned at the On setting, access to the front
and rear processing center covers of the processing module is permitted when the procedure is
in process. The SCM procedure key is required for procedures that use the reagent and sample
manager (RSM) and require access to the front processing center cover.
NOTE: When procedures are performed with the procedure key positioned at the On setting,
important safety features are bypassed and the operator may be exposed to one or more of the
following potential hazards:
• CAUTION: Biological RISKS. This activity or area may expose you to potentially

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• CAUTION: Chemical Hazard. This activity or area exposes you to a chemical

hazard.
• CAUTION: Moving Parts. This activity or area may expose you to moving parts.
• CAUTION: Probe Stick Hazard. This activity or area may expose you to probes.
Be aware of moving parts. Do not reach into the processing center during system operation.
1. To access each procedure lock, perform the following steps:
– Open the front electronics door of the processing module.
– Open the SCM front door.
2. Insert the procedure key into the procedure lock, and then turn the key to the On (white dot)
setting.
Figure 159: Procedure key for the SCM

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Figure 160: Procedure key for the Alinity c

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Figure 161: Procedure key for the Alinity i
3. Perform the procedure that requires the procedure key.

4. Turn the procedure key to the Off setting (black dot), and then remove the key.
5. Close the front electronics door of the processing module and the SCM front door.
Perform a maintenance procedure or a diagnostic procedure

Perform this procedure to perform and track maintenance and diagnostic procedures.
The Maintenance tab includes scheduled procedures to perform and as-needed cleaning
procedures to perform.
The Diagnostics tab includes procedures that can be used to confirm the status of assemblies
and mechanisms to help identify and resolve operational problems.

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CAUTION: Maintenance and diagnostic procedures may expose operators to one or

more potentially hazardous conditions. Untrained operators must not perform these
procedures.
1. On the menu bar, tap Procedures.
The default is the Maintenance tab. To perform diagnostic procedures, tap the Diagnostics
tab.
NOTE: If Procedures is not an icon on the menu bar, tap System, and then tap
Procedures.
2. On the Procedures screen, tap a Module button.
The Maintenance tab displays To Do procedures. The Diagnostics tab displays All
procedures.
3. On the right side of the Procedures screen, tap a tab.
4. Under Procedure, tap a procedure.
5. Tap Perform.
On the Perform Procedure screen, a procedure description is displayed in the Instructions
box. If a procedure is selected by mistake, tap Quit to exit the procedure.
6. To perform the procedure, tap the Proceed user input button.
7. Follow the instructions in the Instructions box.
Some procedures have pictures and videos to use as aids to perform the procedure. The
Show Video button and the Show Picture button are displayed when pictures and videos
are available.
8. To leave the procedure while it is in process, tap any icon on the menu bar.
The system software provides the ability to perform a procedure on a different module or to
use other areas of the user interface while a procedure runs in the background. If a
procedure uses the reagent and sample manager (RSM) (which is controlled by the system
control module procedure key), it cannot be performed concurrently with another procedure
that also uses the RSM, with the exception of 2500 Daily Maintenance.
When a procedure requires an operator response, an amber badge is displayed on the
Procedures icon.
NOTE: The In Process tab of the Procedures screen displays procedures in process.
9. To print a procedure report, tap Print.
10. To complete the procedure, tap Done.
Return to a maintenance procedure or a diagnostic procedure in process, page 851

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Return to a maintenance procedure or a diagnostic procedure in process

Perform this procedure to return to the Perform Procedure screen of an in-process maintenance
procedure or an in-process diagnostic procedure. The operator must return to this screen to
provide a response when required or to complete the procedure.
NOTE: If a procedure requires a response, the In Process tab is displayed. If the tab is not
displayed, tap the In Process tab.
2. On the Procedures screen, tap a Module button.
3. Under Procedure, tap an in-process procedure.
4. Tap Continue.
5. On the Perform Procedure screen, follow the instructions in the Instructions box.
6. To print a procedure report, tap Print.
7. To complete the procedure, tap Done.
Procedures Log screen

On the Procedures Log screen, the operator can view information about maintenance and
diagnostic procedures that were performed. The system stores data for a maximum of 2 years.
• Approve a log.
• Print a log.
• Add a comment to a procedure.
Procedures Log screen, Maintenance tab element descriptions, page 852
Procedures Log screen, Diagnostics tab element descriptions, page 853
Details for Log flyout element descriptions, page 854
Add a comment to a maintenance procedure or a diagnostic procedure, page 855
Approve a maintenance log, page 856

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Procedures Log screen, Maintenance tab element descriptions
Maintenance tab
The Maintenance tab displays the maintenance logs. The following list explains the descriptive
elements of the maintenance logs:
• A gray box indicates that the procedure has a status of Scheduled, Pending, Canceled, Not
Performed, or Failed. If the procedure is performed multiple times on the same day, the
status of the last performed procedure is displayed.
Tap the box to display the Details for Log flyout.
• A blue box indicates that the procedure has been performed and has a status of Completed.
• An asterisk within the box indicates that a comment has been entered for the procedure in
the Details for Log flyout.
• A number within the box indicates that the procedure was performed multiple times on the
same day.
• No box indicates that the procedure was not performed or scheduled for that day.
Elements
Module bar Used to select an individual module to view the maintenance

logs.
Procedure Displays the name of the maintenance procedure.
Status Displays the approval status of the selected maintenance log.

The statuses are Approved and Unapproved.
Operator ID Displays the identification of the operator who approved the

log. The element is blank if the log has not been approved.
Approval Date/Time Displays the date and time that the log was approved. The
element is blank if the log has not been approved.
Activity Month Displays the month and year for the log displayed.
Back and Forward Navigate to the previous or next maintenance log.

buttons

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Function buttons
Procedures Navigates to the Procedures screen.
Approve Used to approve the maintenance log for the month displayed.
Procedures Log screen, Diagnostics tab element descriptions
Diagnostics tab
The Diagnostics tab displays the diagnostic logs. The following list explains the descriptive
elements of the diagnostic logs:
• A gray box indicates procedures that did not complete successfully. If the procedure is
performed multiple times on the same day, the status of the last performed procedure is
displayed.
• A blue box indicates that the procedure has been performed and has a status of Completed.
• An asterisk within the box indicates that a comment has been entered for the procedure in
the Details for Log flyout.
• A number within the box indicates that the procedure was performed multiple times on the
same day.
• No box indicates that the procedure was not performed or scheduled for that day.
Elements
Module bar Used to select an individual module to view the diagnostic

logs.
Procedure Displays the name of the diagnostic procedure.
Activity Month Displays the month and year for the log displayed.
Back and Forward Navigates to the previous or next diagnostic log.

buttons

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Function buttons
Procedures Navigates to the Procedures screen.
Details for Log flyout element descriptions

The Details for Log flyout provides details of the selected maintenance or diagnostic procedure.
Elements
Procedure Displays the name of the selected maintenance or diagnostic

procedure.
Version Displays the version number of the procedure.
Category Displays the category of the maintenance or diagnostic

procedure.

system when the procedure was performed. For maintenance
logs, this element is blank if the procedure has a status of
Scheduled, Pending, or Not Performed.
Completion Date Displays the date and time that the procedure is completed.
For maintenance logs, this element is blank if the procedure
has a status of Scheduled, Pending, or Not Performed.
Completion Status Displays the final status of the completed procedure.
Comment Displays a text box that is used to enter comments for the
selected procedure.
Results Displays results generated for the selected procedure.

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Function buttons


Previous Displays the previously viewed details for the log. The button
is displayed only when the procedure is performed multiple
times on the same day.
Next Displays the next details for the log. The button is displayed
only when the procedure is performed multiple times on the
same day.

Add a comment to a maintenance procedure or a diagnostic procedure

Perform this procedure to add a comment to a procedure listed in the maintenance log or the
diagnostic log. Add comments as needed to document the following information:
• Why a maintenance procedure was not completed when scheduled
• Why a procedure failed or was repeated
• Why a nonscheduled procedure was performed

NOTE: If Procedures is not an icon on the menu bar, tap System, and then tap Procedures.
2. On the Procedures screen, tap Log.
3. On the Log screen, tap a Module button.
4. In the Activity Month area, tap the Right Arrow and Left Arrow buttons to display the
needed month.
5. Under Procedure, find the needed procedure.
If the procedure is not displayed on the screen, flick up and down to view more procedures.
6. To display the procedure in the Details for Log flyout, tap a date for the procedure.

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7. If the procedure was performed multiple times on that date, tap Next or Previous to display
the details for each time that the procedure was performed.
8. In the Comments box, type a comment.
9. To save the comment and return to the Log screen, tap Done.
To discard the comment and return to the Log screen, tap Cancel.
Approve a maintenance log
Perform this procedure to approve a monthly maintenance log.

NOTE: The maintenance log can be approved on the first day of the next month.
NOTE: If Procedures is not an icon on the menu bar, tap System, and then tap Procedures.
2. On the Maintenance tab of the Procedures screen, tap Log.
3. In the Activity Month area, tap the Left Arrow and Right Arrow buttons to display the
needed month.
4. Tap Approve.
The status of the maintenance log changes from unapproved to approved and displays the
operator ID and the approval date and time.
Descriptions of maintenance and diagnostic procedure statuses

Maintenance and diagnostic procedure status refers to the completion status of a procedure.
Procedures have the following completion statuses:
Scheduled A maintenance procedure is scheduled for a future date.
Pending A maintenance procedure is scheduled for the current date.
Completed The procedure is completed. For procedures that produce

results with pass-or-fail criteria, all results passed.
User Canceled Quit is selected before the procedure is completed.

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Failed The procedure generated an error or a failed result.
<Blank> The procedure has not been performed.
Running The procedure is in process.
Waiting user response The procedure in process requires an operator response.
Not performed The maintenance procedure was not performed on the date
due.
Version Details for Procedure flyout element descriptions, page 841
Diagnostic History Report, Maintenance History Report element descriptions, page 1661
Maintenance procedure descriptions

Maintenance procedures are grouped first by module type and then by category. The type of
module determines the categories and procedures that are available. Each category is
represented by a tab on the right side of the Maintenance tab of the Procedures screen.
The To Do tab displays scheduled procedures for the selected module.
The All tab displays all procedures for the selected module. Each additional tab represents a
frequency (for example, Daily or Weekly). Any procedure that is displayed can be performed
even if it is not scheduled.
Maintenance suggestions, page 857
Processing module maintenance procedures (c‑series), page 858
Processing module maintenance procedures (i‑series), page 868
Reagent and sample manager (RSM) maintenance procedures, page 872
Maintenance suggestions
The appropriate maintenance of the system is important. Abbott Laboratories provides
suggestions for efficient strategies to perform maintenance procedures and reduce downtime.
When scheduling and performing maintenance procedures:
• Schedule maintenance procedures for times when the workflow is slow.

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• Verify that adequate supplies are loaded, or are available to load, on the system before
initiating a maintenance procedure.
• Perform procedures within a maintenance category on different shifts or days. To avoid
scheduling these procedures for the same day, perform some of them early to stagger the
schedule.
NOTE: All maintenance procedures must be completed on or before the due date.
Processing module maintenance procedures (c‑series)

Maintenance procedures for the c‑series processing module are grouped by the module type
and by frequency categories on the Maintenance tab of the Procedures screen.
Daily maintenance procedures (c‑series), page 858
Weekly maintenance procedures (c‑series), page 859
Monthly maintenance procedures (c‑series), page 860
Quarterly maintenance procedures (c‑series), page 860
Triannual maintenance procedures (c‑series), page 863
As-needed maintenance procedures (c‑series), page 865
Daily maintenance procedures (c‑series)

Daily maintenance procedures are required on the c‑series processing module.
5501 Daily Maintenance (c‑series)

Perform this Daily maintenance procedure to complete the following tasks:
• Flush the water lines of the sample, the reagent, and the cuvette washer.
• Exchange the water in the water bath.
• Add Water Bath Additive to the water bath.
• Wash the ICT module with ICT Reference Solution and Cleaning Solution.
• Drain and fill the ICT Reference Solution cup.
• Wash the sample and reagent probes and the mixers with Acid Probe Wash and Detergent
A.
• Clean the sample probe, the R2 probe, and the mixers with Cleaning Solution.

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• Clean the sample probe exterior (only for whole blood).
Estimated time 12 minutes

Required materials • c‑series Maintenance Solutions, LN 08P9870 or LN
08P9871 (USA)
• Purified water (required only for systems with whole blood
applications)
• Cotton swabs (required only for systems with whole blood
applications)
Required instrument Warming or Idle

status
Procedure key setting Processing module: Required On
Daily maintenance procedures (c‑series), page 858
Weekly maintenance procedures (c‑series)

Weekly maintenance procedures are required on the c‑series processing module.
5601 Clean Cuvettes with Detergent A (c‑series), page 859
5601 Clean Cuvettes with Detergent A (c‑series)

Perform this Weekly maintenance procedure to wash all cuvettes and to fill them with Detergent
A solution.
Required materials None

status
Weekly maintenance procedures (c‑series), page 859

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Monthly maintenance procedures (c‑series)

Monthly maintenance procedures are required on the c‑series processing module.
5701 Clean ICT Drain Tip (c‑series), page 860
5701 Clean ICT Drain Tip (c‑series)

Perform this Monthly maintenance procedure to clean the ICT drain tip.

Required materials • Lint-free tissue
• Purified water

status
Procedure key setting Processing module: Off
Monthly maintenance procedures (c‑series), page 860
Quarterly maintenance procedures (c‑series)

Quarterly maintenance procedures are required on the c‑series processing module.
5801 Sample Syringe Maintenance (c‑series), page 860
5802 Wash Solution Syringe Maintenance (c‑series), page 861
5803 Reagent Syringe Maintenance (c‑series), page 862
5806 Change Lamp (c‑series), page 862
5808 Inspect Wash Cup Tubing (c‑series), page 863
5801 Sample Syringe Maintenance (c‑series)

Perform this Quarterly maintenance procedure to replace the sample syringe O-ring and sample
syringe seal tips 1 and 2.

Required materials • Phillips screwdriver

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• Slotted screwdriver
• 10 mm wrench
• Absorbent towel
• Sample and Wash Solution Syringe O-ring, LN 09D5203
• Sample and Wash Solution Syringe Seal Tip #1, LN
09D3703
09D3803
• Cotton swabs

status
Procedure key setting Processing module: Optional On
5802 Wash Solution Syringe Maintenance (c‑series)

Perform this Quarterly maintenance procedure to replace the wash solution syringe O-ring and
wash solution syringe seal tips 1 and 2.

• 10 mm wrench
• Absorbent towel
• Sample and Wash Solution Syringe O-ring, LN 09D5203
09D3703
09D3803
• Cotton swabs

status

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5803 Reagent Syringe Maintenance (c‑series)

Perform this Quarterly maintenance procedure to replace the reagent syringe O-rings and
reagent syringe seal tips 1 and 2.

• 15 mm wrench
• Absorbent towel
• Reagent Syringe O-ring, LN 09D5303
• Reagent Syringe Seal Tip #1, LN 09D3903
• Cotton swabs

status
5806 Change Lamp (c‑series)

Perform this Quarterly maintenance procedure to change the lamp.

• Gloves
• Source lamp, LN 09D4503
• Lint-free tissue (optional)
• Ethanol (optional)

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status
5808 Inspect Wash Cup Tubing (c‑series)

Perform this Quarterly maintenance procedure to inspect the wash cup tubing.

Required materials • 3 mm hex wrench

status
Triannual maintenance procedures (c‑series)

Triannual maintenance procedures are required on the c‑series processing module.
5833 Change 1 mL Syringes (c‑series), page 863
5834 Check and Change ICT Check Valves (c‑series), page 864
5835 Check and Clean High-Concentration Waste Sensor (c‑series), page 864
5833 Change 1 mL Syringes (c‑series)

Perform this Triannual maintenance procedure to change the 1 mL syringes on the following
pumps:
• ICT Reference Solution pump
• ICT aspiration pump
• Wash solution pump

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Required materials • Seven 1 mL syringes, LN 09D4103 (If the system is not

configured to use the ICT module, only three 1 mL
syringes are required.)
• Absorbent towels

status
5834 Check and Change ICT Check Valves (c‑series)

Perform this Triannual maintenance procedure to change the ICT aspiration check valve and to
confirm the functionality of the ICT Reference Solution check valves.

Required materials • Absorbent towel
• ICT check valve, LN 09D3503
• Beaker that is large enough to hold the 1 mL syringe and
the check valve
• Purified water

status
5835 Check and Clean High-Concentration Waste Sensor (c‑series)

Perform this Triannual maintenance procedure to test the functionality of the high-concentration
waste sensor and to clean the sensor.
NOTE: This procedure is required only if the high-concentration waste bottle is installed.

Required materials • Absorbent towels

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• 0.5% sodium hypochlorite solution

• Beaker that is large enough to hold the high-
concentration waste sensor

status
As-needed maintenance procedures (c‑series)

The operator can perform as-needed maintenance procedures for the c‑series processing
module to clean cuvettes and module-specific reagent and sample manager (RSM) mechanisms
when messages codes and observed problems associated with the cuvettes and the module-
specific RSM are diagnosed.
5901 Clean Wash Cups (c‑series), page 865
5906 Clean Sample and Reagent Probes (c‑series), page 866
5907 Clean Mixers (c‑series), page 866
5908 Clean Cuvette Washer Nozzles (c‑series), page 867
5910 Wash Cuvettes (c‑series), page 867
5925 Manual RSM Loading Area and Positioners Cleaning (c‑series), page 867
5901 Clean Wash Cups (c‑series)

Perform this As-Needed maintenance procedure to clean the processing module wash cups.

• 150 mL 2.5% sodium hypochlorite solution
• Lint-free tissue
• Two syringes that can dispense 25 mL
• Cotton swabs
• Purified water

status

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5906 Clean Sample and Reagent Probes (c‑series)

Perform this As-Needed maintenance procedure to clean the exterior surfaces of the sample
probe, the R1 probe, and the R2 probe.

Required materials • Aliquot of Detergent A from a cartridge
• Purified water
• Cotton swabs
• Absorbent tissue

status
5907 Clean Mixers (c‑series)

Perform this As-Needed maintenance procedure to clean mixer 1 and mixer 2.

Required materials • 70% isopropyl alcohol
• Cotton swabs
• Purified water

status

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5908 Clean Cuvette Washer Nozzles (c‑series)

Perform this As-Needed maintenance procedure to clean the cuvette washer nozzles.
Required materials Nozzle cleaning wire

status
5910 Wash Cuvettes (c‑series)

Perform this As-Needed maintenance procedure to wash all cuvettes with Alkaline Wash, Acid
Wash, and water.

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5925 Manual RSM Loading Area and Positioners Cleaning (c‑series)

Perform this As-Needed maintenance procedure to clean manually the loading area, sample
positioners, and reagent positioner of the module-specific reagent and sample manager (RSM).
Estimated time 4 minutes*

* This time does not include the 10 minutes of contact time
that is required for 0.5% sodium hypochlorite solution.
Required materials • 0.5% sodium hypochlorite solution
• Quaternary ammonium detergent

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Procedure key setting • System control module: Required On
• Processing module: Required On
Processing module maintenance procedures (i‑series)

Maintenance procedures for the i‑series processing module are grouped by the module type and
by frequency categories on the Maintenance tab of the Procedures screen.
Daily maintenance procedures (i‑series), page 868
Weekly maintenance procedures (i‑series), page 869
Semiyearly maintenance procedures (i‑series), page 870
As-needed maintenance procedures (i‑series), page 871
Daily maintenance procedures (i‑series)

Daily maintenance procedures are required on the i‑series processing module.
2500 Daily Maintenance (i‑series)

Perform this Daily maintenance procedure to complete the following tasks:
• Clean and condition the sample pipettor probe.
• Clean wash zone 1 probes and wash zone 2 probes with 0.5% sodium hypochlorite solution.
• Flush and prime the Pre-Trigger Solution and the Trigger Solution.
NOTE: This maintenance procedure can be performed concurrently on systems that have
redundant Alinity i processing modules.

* This procedure may require an additional 5 minutes to
25 minutes if a bulk solution transfer is necessary.

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Required materials • Maintenance Cleaning Cartridge, LN 02R52

NOTE: The prepared solution is stable for 30 days.
• Measuring device that can deliver 25 mL
• Probe Conditioning Solution, LN 01R5840 (in the reagent
carousel)

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Procedure key setting • System control module: Optional On
• Processing module: Optional On
Daily maintenance procedures (i‑series), page 868
Weekly maintenance procedures (i‑series)

Weekly maintenance procedures are required on the i‑series processing module.
2620 Manual Pipettor Probe Cleaning (i‑series), page 869
2625 Manual Wash Zone Probe Cleaning (i‑series), page 870
2630 Manual Wash Cup Cleaning (i‑series), page 870
2620 Manual Pipettor Probe Cleaning (i‑series)

Perform this Weekly maintenance procedure to remove manually the salt buildup from the
reagent 1, reagent 2, and sample pipettor probes.

Required materials • Purified water
• Cotton swabs

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2625 Manual Wash Zone Probe Cleaning (i‑series)

Perform this Weekly maintenance procedure to remove manually the salt buildup from the wash
zone 1 and wash zone 2 probes.

• Cotton swabs

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2630 Manual Wash Cup Cleaning (i‑series)

Perform this Weekly maintenance procedure to remove manually the salt buildup from the
reagent 1, reagent 2, and sample wash cups (including the induction heater wash cup where
applicable) and the wash cup baffles.

• Cotton swabs

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Semiyearly maintenance procedures (i‑series)

Semiyearly maintenance procedures are required on the i‑series processing module.
2850 Air Filter Cleaning (i‑series), page 871

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2850 Air Filter Cleaning (i‑series)

Perform this Semiyearly maintenance procedure to remove manually the dust buildup from the
processing module air filters. Rotating between two sets of air filters is recommended because
the filters must be dry when they are reinstalled.

Required materials • Two Filters, Processing Center, LN 04S6701
• Tap water

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Semiyearly maintenance procedures (i‑series), page 870
As-needed maintenance procedures (i‑series)

The operator can perform as-needed maintenance procedures for the i‑series processing
module to clean and decontaminate the processing module or module-specific reagent and
sample manager (RSM) mechanisms after a spill has occurred or when message codes and
observed problems associated with the processing module or the module-specific RSM are
diagnosed.
2925 Manual RSM Loading Area and Positioner Cleaning (i‑series), page 871
2925 Manual RSM Loading Area and Positioner Cleaning (i‑series)

Perform this As-Needed maintenance procedure to clean manually the loading area, sample
positioners, and reagent positioner of the module-specific reagent and sample manager (RSM).

Required materials • 0.5% sodium hypochlorite solution

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As-needed maintenance procedures (i‑series), page 871
Reagent and sample manager (RSM) maintenance procedures

Maintenance procedures for the reagent and sample manager are grouped by the module type
and by frequency categories on the Maintenance tab of the Procedures screen.
As-needed maintenance procedure (RSM), page 872
As-needed maintenance procedure (RSM)

The operator can perform the as-needed maintenance procedure for the reagent and sample
manager (RSM) to clean RSM mechanisms after a spill has occurred or when message codes
and observed problems associated with the RSM are diagnosed.
Reagent and sample manager (RSM) maintenance procedures, page 872
2920 Manual RSM Transport Cleaning, page 872
2920 Manual RSM Transport Cleaning

Perform this As-Needed maintenance procedure to clean manually the bar code reader mirror
and transport arm of the reagent and sample manager (RSM).

Required materials • 0.5% sodium hypochlorite solution**
• Quaternary ammonium detergent**
• Isopropyl alcohol***
• Microfiber cloth***
** These items are only for the RSM transport arm.

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*** These items are only for the RSM bar code reader mirror.

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Procedure key setting System control module: Required On
As-needed maintenance procedure (RSM), page 872
Unscheduled cleaning
Some system components may need to be cleaned or decontaminated because of normal use
from daily system operations or because of spills.
Clean and decontaminate external components, page 873
Clean and decontaminate the bar code scanner, page 874
Clean and decontaminate external components

Required materials • Lint-free tissues
Perform this procedure to clean and decontaminate the following components:

• Processing module external surfaces
• System control module external surfaces
• RV waste container (i‑series)
• Sample racks
• Vial racks
• Trays

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1. Wipe the surface area with a quaternary ammonium detergent.

2. Mist or wipe the surface area with 0.5% sodium hypochlorite solution. Let the disinfectant
remain on the surface for a minimum of 10 minutes of contact time.
regulations.
Clean and decontaminate the bar code scanner


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Perform this procedure to clean and decontaminate the bar code scanner.
1. Wipe the surface area and scan window of the bar code scanner with a quaternary
ammonium detergent.
2. Mist or wipe the surface area and the scan window with 0.5% sodium hypochlorite solution.
Let the disinfectant remain on the surface for a minimum of 10 minutes of contact time.
regulations.
Clean and decontaminate the monitor


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Perform this procedure to clean and decontaminate the monitor.

NOTE: Before the procedure is performed, the monitor must be powered off. Thoroughly read
the procedure and print a copy of it to use as a reference.
1. Power off the monitor. Do not wipe the screen while the monitor is turned on.
2. Wipe the screen with a quaternary ammonium detergent.
3. Mist or wipe the screen with 0.5% sodium hypochlorite solution. Let the disinfectant remain
on the screen for a minimum of 10 minutes of contact time.
4. When the screen is dry, power on the monitor.
regulations.
Print a topic from the operations manual, page 51
Diagnostic procedure descriptions

Diagnostic procedures are grouped first by module type and then by category. The type of
module determines the categories and procedures that are available. Each category is
represented by a tab on the right side of the Diagnostics tab of the Procedures screen.
The All tab displays all procedures for the selected module. Each additional tab represents a
functional subsection of the system.
Processing module diagnostic procedures (c‑series), page 875
Processing module diagnostic procedures (i‑series), page 892
Reagent and sample manager (RSM) diagnostic procedures, page 916
Processing module diagnostic procedures (c‑series)

Diagnostic procedures for the c‑series processing module are grouped by functional categories
on the Diagnostics tab of the Procedures screen.

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Optics diagnostic procedures (c‑series), page 876
Pipettor diagnostic procedures (c‑series), page 877
Fluidics-wash diagnostic procedures (c‑series), page 882
Temperature diagnostic procedures (c‑series), page 885
Sample manager diagnostic procedures (c‑series), page 885
Reagent manager diagnostic procedures (c‑series), page 886
Module diagnostic procedures (c‑series), page 888
Reaction mechanism diagnostic procedures (c‑series), page 889
ICT diagnostic procedures (c‑series), page 891
Optics diagnostic procedures (c‑series)

The operator may need to perform optics diagnostic procedures when optics components are
replaced or when message codes and observed problems associated with the optics are
diagnosed.
4001 Optics Trigger Sensor Check (c‑series), page 876
4002 Absorbance Reads (c‑series), page 876
4005 Cuvette Integrity Test (c‑series), page 877
4001 Optics Trigger Sensor Check (c‑series)

Perform this Optics diagnostic procedure to test the functionality of the optics trigger sensor.

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4002 Absorbance Reads (c‑series)

Perform this Optics diagnostic procedure to measure absorbance readings and to generate a
printed report for manually pipetted samples.

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Estimated time 11 minutes for each cuvette segment that is used

Required materials • Sample
• Calibrated pipettor with disposable tips that can dispense
160 µL to 250 µL

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4005 Cuvette Integrity Test (c‑series)

Perform this Optics diagnostic procedure to test the condition of each one of the 187 cuvettes in
the reaction carousel.
Estimated time 1 minute

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Pipettor diagnostic procedures (c‑series)

The operator may need to perform pipettor diagnostic procedures when pipettor components are
replaced or when message codes and observed problems associated with the pipettor are
diagnosed.
4102 Sample Pipettor Calibration (c‑series), page 878
4103 R1 Pipettor Calibration (c‑series), page 878
4104 R2 Pipettor Calibration (c‑series), page 879
4106 Component Move (c‑series), page 879
4107 Sample Pipettor LAS Calibration (c‑series), page 879
4109 Probe Alignment Test (c‑series), page 880

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4110 Crash Sensor Test (c‑series), page 881

4113 Pipettor Check (c‑series), page 881
4102 Sample Pipettor Calibration (c‑series)

Perform this Pipettors diagnostic procedure to calibrate the sample pipettor.

Required materials • Cuvette Segment Alignment Tool, LN 04S70
• Tap water
• 16 mm x 100 mm sample tube

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4103 R1 Pipettor Calibration (c‑series)

Perform this Pipettors diagnostic procedure to calibrate the R1 pipettor.

• Tap water

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4104 R2 Pipettor Calibration (c‑series)

Perform this Pipettors diagnostic procedure to calibrate the R2 pipettor.

• Tap water

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4106 Component Move (c‑series)

Perform this Pipettors diagnostic procedure to move the sample, R1, and R2 pipettors and the
mixers for component replacement and troubleshooting.

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4107 Sample Pipettor LAS Calibration (c‑series)

Perform this Pipettors diagnostic procedure to complete the following tasks:
• Confirm the current sample pipettor calibration at the laboratory automation system (LAS)
aspiration position.
• Calibrate the sample pipettor at the LAS aspiration position and the LAS wash cup.

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Required materials • Short calibration tool (supplied by the LAS vendor)

• Tall calibration tool (supplied by the LAS vendor)
• Cotton swabs
• Tap water
• 13 mm x 75 mm sample tube or any sample tube that
meets the system specifications

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Sample cup and tube specifications and requirements, page 473
4109 Probe Alignment Test (c‑series)

Perform this Pipettors diagnostic procedure to move the sample, R1, and R2 pipettors over the
aspiration, dispense, and wash positions to confirm visually the alignment.
Estimated time • 6 minutes for the sample pipettor
• 4 minutes for the R1 pipettor
• 15 minutes for all pipettors
Required materials • Two sample racks

• Two sample cups
• Two 16 mm x 100 mm sample tubes
(Large), LN 04S1740
• Phillips screwdriver
• Graduated cylinder that can deliver up to 35 mL
• Tap water or saline

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4110 Crash Sensor Test (c‑series)

Perform this Pipettors diagnostic procedure to test the crash sensor for the sample, R1, and R2
pipettors.
Estimated time • 1 minute for one pipettor

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4113 Pipettor Check (c‑series)

Perform this Pipettors diagnostic procedure to confirm visually the sample, R1, and R2 pipettors
for precision and accuracy.
Estimated time • 14 minutes for the sample pipettor
Required materials • Tap water or saline

(Large), LN 04S1740
• 16 mm x 100 mm sample tube
• Calibrated pipettor that can deliver 150 µL

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Fluidics-wash diagnostic procedures (c‑series)

The operator may need to perform fluidics-wash diagnostic procedures when components from
the following systems are replaced or when message codes and observed problems associated
with the following systems are diagnosed:
• Bulk solutions
• Cuvette washer
• Pumps and valves
• Wash cups
4205 Flush Water Lines (c‑series), page 882
4206 Flush Bulk Solutions (c‑series), page 883
4207 Move Cuvette Washer (c‑series), page 883
4208 Probe and Mixer Wash (c‑series), page 883
4212 Bulk Solution Sensor Test (c‑series), page 884
4213 Liquid Level Sense Test (c‑series), page 884
4205 Flush Water Lines (c‑series)

Perform this Fluidics-Wash diagnostic procedure to flush the sample, reagent, and cuvette
washer water lines.

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4206 Flush Bulk Solutions (c‑series)

Perform this Fluidics-Wash diagnostic procedure to flush the following bulk solutions:
• Acid Wash
• Alkaline Wash
• ICT Reference Solution

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4207 Move Cuvette Washer (c‑series)

Perform this Fluidics-Wash diagnostic procedure to vertically move the cuvette washer.

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4208 Probe and Mixer Wash (c‑series)

Perform this Fluidics-Wash diagnostic procedure to wash mixers, sample probes, and reagent
probes with water, Acid Probe Wash solution, Detergent A solution, or Detergent B solution.
Required materials Detergent B, LN 08P9780

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4212 Bulk Solution Sensor Test (c‑series)

Perform this Fluidics-Wash diagnostic procedure to test the functionality of the bulk solution level
sensors.
Estimated time • 1 minute to obtain the current fluid level for all sensors
• 4 minutes to test the functionality of each level sensor

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4213 Liquid Level Sense Test (c‑series)

Perform this Fluidics-Wash diagnostic procedure to test the capability of the sample probe and
reagent probes to detect liquid.

Required materials • Sample rack
• Sample cup
(Large), LN 04S1740
• Measuring device that can deliver 25 mL and 35 mL

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Temperature diagnostic procedures (c‑series)

The operator may need to perform temperature diagnostic procedures when temperature
components are replaced or when message codes and observed problems associated with
c‑series module temperatures are diagnosed.
4301 Temperature Status (c‑series), page 885
4301 Temperature Status (c‑series)

Perform this Temperature diagnostic procedure to display the temperature and status of the
following module components:
• Processing module interior
• Reagent carousel
• Water bath

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Temperature diagnostic procedures (c‑series), page 885
Sample manager diagnostic procedures (c‑series)

The operator may need to perform sample manager diagnostic procedures when reagent and
sample manager (RSM) components are replaced or when message codes and observed
problems associated with the RSM are diagnosed. These procedures are located on the
Procedures screen of the c‑series processing module.
1631 Sample Positioner Test (c‑series), page 886

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1631 Sample Positioner Test (c‑series)

Perform this Sample Manager diagnostic procedure to test the functionality of the sample
positioner motors.

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Sample manager diagnostic procedures (c‑series), page 885
Reagent manager diagnostic procedures (c‑series)

The operator may need to perform reagent manager diagnostic procedures when reagent supply
center components are replaced or when message codes and observed problems associated
with the reagent supply center are diagnosed.
4701 Reagent Carousel Home (c‑series), page 886
4703 Reagent Supply Center Test (c‑series), page 887
4715 Reagent Transport Calibration (c‑series), page 887
4701 Reagent Carousel Home (c‑series)

Perform this Reagent Manager diagnostic procedure to rotate the reagent carousel to the home
position.

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4703 Reagent Supply Center Test (c‑series)

Perform this Reagent Manager diagnostic procedure to test the functionality of the following
items:
• Reagent positioner
• Reagent transport
Estimated time 6 minutes for the full-function test

Required materials • One c‑series Reagent Cartridge, Black (Large), LN
04S1720 or LN 04S1750; or one c‑series Reagent
Cartridge, Clear (Large), LN 04S1740; or one c‑series
cartridge
• Onboard Vial Rack, LN 04S6501

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4715 Reagent Transport Calibration (c‑series)

Perform this Reagent Manager diagnostic procedure to calibrate the reagent transport.

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Module diagnostic procedures (c‑series)

The operator may need to perform module diagnostic procedures when message codes and
observed problems associated with the c‑series module are diagnosed.
4801 Module Initialization (c‑series), page 888
4803 Voltage Test (c‑series), page 888
4801 Module Initialization (c‑series)

Perform this Modules diagnostic procedure to initialize the selected processing module.

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4803 Voltage Test (c‑series)

Perform this Modules diagnostic procedure to test voltages of the following power supplies:
• +5 V
• +11.5 V
• +12 V
• +15 V
• -15 V
• +24 V

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Reaction mechanism diagnostic procedures (c‑series)

The operator may need to perform reaction mechanism diagnostic procedures when reaction
mechanism components are replaced or when message codes and observed problems
associated with reaction mechanism components are diagnosed.
5002 Mixer Vibration Test (c‑series), page 889
5003 Clean Cuvettes - Manually (c‑series), page 889
5004 Reaction Carousel Home and Move (c‑series), page 890
5005 Exchange Water in Bath (c‑series), page 890
5006 Reaction Carousel Calibration (c‑series), page 891
5002 Mixer Vibration Test (c‑series)

Perform this Reaction Mechanisms diagnostic procedure to test the vibration of mixer 1 and
mixer 2 at low and high frequencies.

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5003 Clean Cuvettes - Manually (c‑series)

Perform this Reaction Mechanisms diagnostic procedure to clean the cuvettes manually.
Estimated time • 10 minutes for one segment
• 35 minutes for all segments
Required materials • Slotted screwdriver

• Detergent A, LN 08P9670

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• Cotton swabs
• Purified water
• Clean, residue-free container in which to submerge the
segments
• Gloves

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5004 Reaction Carousel Home and Move (c‑series)

Perform this Reaction Mechanisms diagnostic procedure to rotate the reaction carousel
counterclockwise by one cuvette or one cuvette segment.

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5005 Exchange Water in Bath (c‑series)

Perform this Reaction Mechanisms diagnostic procedure to drain and fill the water bath and to
add Water Bath Additive.
Required materials c‑series Maintenance Solutions, LN 08P9870 or LN 08P9871

(USA)

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5006 Reaction Carousel Calibration (c‑series)

Perform this Reaction Mechanisms diagnostic procedure to calibrate the reaction carousel.

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ICT diagnostic procedures (c‑series)

The operator may need to perform ICT diagnostic procedures when ICT components are
replaced or when message codes and observed problems associated with the ICT unit are
diagnosed.
5101 Flush ICT Reference Solution Cup (c‑series), page 891
5102 Flush ICT Module (c‑series), page 892
5101 Flush ICT Reference Solution Cup (c‑series)

Perform this ICT diagnostic procedure to flush the ICT Reference Solution cup.

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5102 Flush ICT Module (c‑series)

Perform this ICT diagnostic procedure to flush the ICT module with ICT Reference Solution.

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Processing module diagnostic procedures (i‑series)

Diagnostic procedures for the i‑series processing module are grouped by functional categories
on the Diagnostics tab of the Procedures screen.
Optics diagnostic procedures (i‑series), page 892
Pipettor diagnostic procedures (i‑series), page 893
Fluidics-wash diagnostic procedures (i‑series), page 901
Temperature diagnostic procedures (i‑series), page 909
RV loader diagnostic procedures (i‑series), page 910
Process path diagnostic procedures (i‑series), page 910
Sample manager diagnostic procedures (i‑series), page 913
Reagent manager diagnostic procedures (i‑series), page 914
Module diagnostic procedures (i‑series), page 915
Optics diagnostic procedures (i‑series)

The operator may need to perform optics diagnostic procedures when optics components are
replaced or when message codes and observed problems associated with the optics are
diagnosed.
1000 Optics Background (i‑series), page 893
1005 Shutter Test (i‑series), page 893

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1000 Optics Background (i‑series)

Perform this Optics diagnostic procedure to determine optics background readings. This
procedure generates the following readings:
• Background with no reaction vessel (RV)
• Background with an empty RV
• Background with Pre-Trigger Solution in the RV
For the procedure to pass, raw counts must be between 3 relative light units (RLUs) and
500 RLUs. In addition, specifications of the software background quality checks must not
generate an error.

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1005 Shutter Test (i‑series)

Perform this Optics diagnostic procedure to test the functionality of the shutter.

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Pipettor diagnostic procedures (i‑series)

The operator may need to perform pipettor diagnostic procedures when pipettor components are
replaced or when message codes and observed problems associated with the pipettor are
diagnosed.

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1100 Pipettor Motors Test (i‑series), page 894
1105 Pipettor Syringe and Pump Test (i‑series), page 894
1111 Sample Pipettor Check and Calibration (i‑series), page 895
1112 R1 Pipettor Check and Calibration (i‑series), page 895
1113 R2 Pipettor Check and Calibration (i‑series), page 896
1115 Sample Pipettor LAS Calibration (i‑series), page 896
1120 Sample Pipettor Syringe Precision and Accuracy (i‑series), page 897
1121 R1 Pipettor Syringe Precision and Accuracy (i‑series), page 897
1122 R2 Pipettor Syringe Precision and Accuracy (i‑series), page 898
1130 Sample Pipettor Pump Precision and Accuracy (i‑series), page 898
1131 R1 Pipettor Pump Precision and Accuracy (i‑series), page 899
1132 R2 Pipettor Pump Precision and Accuracy (i‑series), page 899
1160 Liquid Level Sense Test (i‑series), page 900
1161 Pipettor Probe Move (i‑series), page 901
1100 Pipettor Motors Test (i‑series)

Perform this Pipettors diagnostic procedure to test the functionality of theta and Z motors of
sample, R1, and R2 pipettors.
Estimated time • 2 minutes for each pipettor

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1105 Pipettor Syringe and Pump Test (i‑series)

Perform this Pipettors diagnostic procedure to test the functionality of the following components
of sample, R1, and R2 pipettors:
• Syringe motors
• Syringe valves
• 100 µL buffer pumps

80000071-105 - 2018-09-10

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1111 Sample Pipettor Check and Calibration (i‑series)

• Set the position of the sample probes that are necessary to aspirate and dispense
specimens during assay processing.
• Determine the probe straightness.
Estimated time • 14 minutes for pipettor calibration

• 4 minutes for probe straightness
Required materials • Water (purified or tap)


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1112 R1 Pipettor Check and Calibration (i‑series)

• Set the position of the R1 probe that is necessary to aspirate and dispense reagents during
assay processing.

80000071-105 - 2018-09-10


• Cotton swab

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1113 R2 Pipettor Check and Calibration (i‑series)

• Set the position of the R2 probe that is necessary to aspirate and dispense reagents during
assay processing.


• Cotton swab

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1115 Sample Pipettor LAS Calibration (i‑series)

Perform this Pipettors diagnostic procedure to verify that the sample probe is positioned
correctly at the laboratory automation system (LAS) track. The procedure allows the operator to
calibrate the sample pipettor if the position is not optimal.

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Estimated time 4 minutes without adjustments to the LAS or the Alinity i

Required materials • Tall calibration tool (supplied by the LAS vendor)
• Short calibration tool (supplied by the LAS vendor)

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1120 Sample Pipettor Syringe Precision and Accuracy (i‑series)

Perform this Pipettors diagnostic procedure to confirm visually the precision and accuracy of the
sample pipettor syringe aspiration and dispense.

Required materials • Sample cup
• Sample rack
• Calibrated manual pipettor that can pipette 250 µL

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1121 R1 Pipettor Syringe Precision and Accuracy (i‑series)

R1 pipettor syringe aspiration and dispense.


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Required materials • Diagnostics Kit, LN 01R59


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1122 R2 Pipettor Syringe Precision and Accuracy (i‑series)

R2 pipettor syringe aspiration and dispense.

Required materials • Diagnostics Kit, LN 01R59

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1130 Sample Pipettor Pump Precision and Accuracy (i‑series)

sample pipettor pump dispense.

Required materials • Water (tap or purified)

80000071-105 - 2018-09-10

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1131 R1 Pipettor Pump Precision and Accuracy (i‑series)

R1 pipettor pump dispense.


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1132 R2 Pipettor Pump Precision and Accuracy (i‑series)

R2 pipettor pump dispense.


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1160 Liquid Level Sense Test (i‑series)

Perform this Pipettors diagnostic procedure to test the capability of a probe to detect liquid in
sample positioners, the process path, the pretreatment path, and the reagent carousel.
For each of the following positions, tests for noise and for the liquid level sense response
between air and fluid are performed:
• Sample positioner inner lane
• Sample positioner outer lane
• Sample pretreatment RV 48
• R1 inner reagent carousel
• R1 middle reagent carousel
• R1 outer reagent carousel
• R1 pretreatment RV 2
• R2 inner reagent carousel
• R2 middle reagent carousel
Estimated time • 1 minute for each position

• 7 minutes for all positions
Required materials Materials can vary based on the option that is selected:
• Diagnostics Kit, LN 01R59
• Sample rack
• Sample cup

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1161 Pipettor Probe Move (i‑series)

Perform this Pipettors diagnostic procedure to move the pipettor probes to an appropriate
position for component replacement.

* This time does not include the time needed to replace the
pipettor probe.

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Fluidics-wash diagnostic procedures (i‑series)

The operator may need to perform fluidics-wash diagnostic procedures when components from
the following systems are replaced or when message codes and observed problems associated
with the following systems are diagnosed:
• Pre-Trigger
• Trigger
• Wash cup
• Wash zone
• Waste
1200 Flush and Prime Fluidics (i‑series), page 902
1201 Induction Heater Test (i‑series), page 902
1202 Wash Cup Valves Test (i‑series), page 903
1205 Wash Buffer Dilution Assembly Test (i‑series), page 903
1206 Pre-Trigger and Trigger Valves and Pumps Test (i‑series), page 903
1207 Trigger Wash Cup Dispense Test (i‑series), page 904
1208 Wash Zone Valves, Pumps, and Motors Test (i‑series), page 904
1209 Empty Bulk Solution Reservoirs (i‑series), page 905
1210 Pre-Trigger Precision and Accuracy (i‑series), page 905

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1211 Trigger Precision and Accuracy (i‑series), page 906

1221 Wash Zone 1 Precision and Accuracy (i‑series), page 906
1222 Wash Zone 2 Precision and Accuracy (i‑series), page 906
1231 Wash Zone 1 Residual Volume (i‑series), page 907
1232 Wash Zone 2 Residual Volume (i‑series), page 907
1261 Wash Zone 1 Wash Monitoring (i‑series), page 908
1262 Wash Zone 2 Wash Monitoring (i‑series), page 908
1270 Bulk Solutions Motors and Sensors Test (i‑series), page 909
1200 Flush and Prime Fluidics (i‑series)

Perform this Fluidics-Wash diagnostic procedure to complete the following tasks:
• Flush one or all pipettors, wash zones, and Pre-Trigger and Trigger systems.
• Flush and prime one or all wash zones and Pre-Trigger and Trigger systems.
• Prime the wash buffer dilution assembly.
Estimated time 1 minute to 10 minutes based on the selected option*


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1201 Induction Heater Test (i‑series)

Perform this Fluidics-Wash diagnostic procedure to test the functionality of the induction heater.
Estimated time 1 minute to 30 minutes based on the selected option

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1202 Wash Cup Valves Test (i‑series)

Perform this Fluidics-Wash diagnostic procedure to test the functionality of sample, R1, and R2
wash cup valves.
Estimated time • 1 minute for each valve
• 3 minutes for all valves

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1205 Wash Buffer Dilution Assembly Test (i‑series)

Perform this Fluidics-Wash diagnostic procedure to test the functionality of the following wash
buffer dilution assembly components:
• Waste valve
• Water inlet valve
• Wash buffer dilution pump
• Conductivity sensor

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1206 Pre-Trigger and Trigger Valves and Pumps Test (i‑series)

Perform this Fluidics-Wash diagnostic procedure to test the functionality of the following Pre-
Trigger and Trigger components:

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• Dispense pumps
• Dispense pump direction valves
• Manifold valves

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1207 Trigger Wash Cup Dispense Test (i‑series)

Perform this Fluidics-Wash diagnostic procedure to confirm that the Trigger Solution is
adequately dispensed to the R1 and R2 wash cups.

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1208 Wash Zone Valves, Pumps, and Motors Test (i‑series)

Perform this Fluidics-Wash diagnostic procedure to test the functionality of the following wash
zone components:
• Manifold valves
• Waste valves
• Dispense pump direction valves
• Motors
• Dispense pumps

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1209 Empty Bulk Solution Reservoirs (i‑series)

Perform this Fluidics-Wash diagnostic procedure to remove the Concentrated Wash Buffer, the
diluted wash buffer, the Trigger Solution, or the Pre-Trigger Solution from the bulk solution or
wash buffer reservoir.
Estimated time 20 minutes to 40 minutes based on the selected options

Required materials • Absorbent tissue
• Purified water

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1210 Pre-Trigger Precision and Accuracy (i‑series)

Perform this Fluidics-Wash diagnostic procedure to confirm visually the precision and accuracy
of the Pre-Trigger dispense.


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1211 Trigger Precision and Accuracy (i‑series)

of the Trigger dispense.


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1221 Wash Zone 1 Precision and Accuracy (i‑series)

of the wash zone 1 dispense.
The system dispenses 200 µL of wash buffer into 15 reaction vessels (RVs) four times each.
The operator accurately dispenses 800 µL of water (tap or purified) into a reference RV.
Compare each RV that was pipetted by the system to the reference RV to determine if the
correct volume was dispensed.

• Calibrated manual pipettor than can pipette 800 µL

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1222 Wash Zone 2 Precision and Accuracy (i‑series)

of the wash zone 2 dispense.
The system dispenses 200 µL of wash buffer into 15 reaction vessels (RVs) four times each.
The operator accurately dispenses 800 µL of water (tap or purified) into a reference RV.

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Compare each RV that was pipetted by the system to the reference RV to determine if the
correct volume was dispensed.


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1231 Wash Zone 1 Residual Volume (i‑series)

Perform this Fluidics-Wash diagnostic procedure to confirm visually the residual liquid volume
that remains in a reaction vessel (RV) after a wash zone 1 dispense and aspiration.

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1232 Wash Zone 2 Residual Volume (i‑series)

Perform this Fluidics-Wash diagnostic procedure to confirm visually the residual liquid volume
that remains in a reaction vessel (RV) after a wash zone 2 dispense and aspiration.

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1261 Wash Zone 1 Wash Monitoring (i‑series)

• Calibrate the wash zone 1 wash monitoring system.
• Confirm the functionality of wash zone 1 aspiration and dispense.
Estimated time 14 minutes for calibration and test

9 minutes only for test

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1262 Wash Zone 2 Wash Monitoring (i‑series)

• Calibrate the wash zone 2 wash monitoring system.
• Confirm the functionality of wash zone 2 aspiration and dispense.
Estimated time 14 minutes for calibration and test

10 minutes only for test

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1270 Bulk Solutions Motors and Sensors Test (i‑series)

Perform this Fluidics-Wash diagnostic procedure to test the functionality of the bulk solution level
sensors.
Estimated time • 1 minute to obtain the current fluid level for all sensors
• 3 minutes to test the functionality of each level sensor
Required materials Absorbent towel

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Temperature diagnostic procedures (i‑series)

The operator may need to perform temperature diagnostic procedures when temperature
components are replaced or when message codes and observed problems associated with
i‑series module temperatures are diagnosed.
1300 Temperature Status (i‑series), page 909
1300 Temperature Status (i‑series)

Perform this Temperature diagnostic procedure to read and display processing module
temperatures and to evaluate the temperature reads at the following positions:
• Process path
• Pre-Trigger and Trigger manifold
• Wash zones
• Reagent supply center

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Temperature diagnostic procedures (i‑series), page 909
RV loader diagnostic procedures (i‑series)

The operator may need to perform RV loader diagnostic procedures when RV loader
components are replaced or when message codes and observed problems associated with the
RV loader are diagnosed.
1400 RV Loader and Sensors Test (i‑series), page 910
1400 RV Loader and Sensors Test (i‑series)

Perform this RV Loader diagnostic procedure to complete the following tasks:
• Home RV loader motors.
• Test RV loader sensors.
• Manually unload reaction vessels from the linear queue.

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RV loader diagnostic procedures (i‑series), page 910
Process path diagnostic procedures (i‑series)

The operator may need to perform process path diagnostic procedures when process path
components are replaced or when message codes and observed problems associated with the
process path are diagnosed.
1505 Diverter Test (i‑series), page 911
1510 Vortexer Test (i‑series), page 911
1515 Process Path Motors Test (i‑series), page 912
1520 RV Load and Unload Test (i‑series), page 912

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1525 Process Path Sensors Test (i‑series), page 912
1505 Diverter Test (i‑series)

Perform this Process Path diagnostic procedure to test the functionality of the following
diverters:
• Load diverter (LD)
• STAT diverter (STD)
• Wash zone diverter (WZD)
• Pretreatment unload diverter (pUD)
Estimated time • 1 minute for each diverter

• 4 minutes for all diverters

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1510 Vortexer Test (i‑series)

Perform this Process Path diagnostic procedure to test the functionality of the following
vortexers:
• Reagent 1 pipettor vortexer (VTXR1)
• Reagent 2 pipettor vortexer (VTXR2)
• Pre-Trigger vortexer (VTXPT)
• Pretreatment vortexer (pVTX)
Estimated time • 1 minute for each vortexer

• 4 minutes for all vortexers

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1515 Process Path Motors Test (i‑series)

Perform this Process Path diagnostic procedure to test the functionality of the process path and
pretreatment path motors.

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1520 RV Load and Unload Test (i‑series)

Perform this Process Path diagnostic procedure to load and unload reaction vessels (RVs) from
the process path and pretreatment path.
Estimated time 3 minutes to 7 minutes based on the selected option

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1525 Process Path Sensors Test (i‑series)

Perform this Process Path diagnostic procedure to test the functionality of the following process
path sensors:
• RV unloader sensor
• RV present sensor
• Process path home sensor

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• Pretreatment path home sensor

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Sample manager diagnostic procedures (i‑series)

The operator may need to perform sample manager diagnostic procedures when reagent and
sample manager (RSM) components are replaced or when message codes and observed
problems associated with the RSM are diagnosed. These procedures are located on the
Procedures screen of the i‑series processing module.
1630 Sample Positioner Test (i‑series), page 913
1630 Sample Positioner Test (i‑series)

Perform this Sample Manager diagnostic procedure to test the functionality of sample positioner
motors.

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Sample manager diagnostic procedures (i‑series), page 913

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Reagent manager diagnostic procedures (i‑series)

The operator may need to perform reagent manager diagnostic procedures when reagent supply
center components are replaced or when message codes and observed problems associated
with the reagent supply center are diagnosed.
1703 Reagent Supply Center Test (i‑series), page 914
1715 Reagent Carousel and Reagent Transport Calibration (i‑series), page 914
1703 Reagent Supply Center Test (i‑series)

Perform this Reagent Manager diagnostic procedure to test the functionality of the following
items:
• Reagent transport
• Dispersion motor
Estimated time 6 minutes for the full-function test

Required materials • Diagnostics Kit, LN 01R59 (one cartridge); or one i‑series
cartridge
• Onboard Vial Rack, LN 04S6501

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1715 Reagent Carousel and Reagent Transport Calibration (i‑series)

Perform this Reagent Manager diagnostic procedure to calibrate the reagent transport to the
reagent carousel to accurately load reagent cartridges and vial racks in the reagent carousel.

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Module diagnostic procedures (i‑series)

The operator may need to perform module diagnostic procedures when message codes and
observed problems associated with the i‑series module are diagnosed.
1805 RV Waste Sensor Test (i‑series), page 915
1830 Buffer Run (i‑series), page 915
1890 Processing Module Initialization (i‑series), page 916
1805 RV Waste Sensor Test (i‑series)

Perform this Modules diagnostic procedure to test the functionality of the RV waste sensor.

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1830 Buffer Run (i‑series)

Perform this Modules diagnostic procedure to run one-step and two-step assay protocols by
using tap water or saline instead of reagents. When troubleshooting is performed for system
failures, assay processing can be simulated without the use of reagents.
Estimated time Variable time based on the number of tests that are ordered.
The minimum completion time is 30 minutes.
Required materials • Diagnostics Kit, LN 01R59 (two cartridges)

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• Sample racks
• Sample cups or tubes

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Procedure key setting • System control module: Off
• Processing module: Off
NOTE: To perform this procedure, the procedure key for the

system control module and the processing module must be
positioned at the Off setting. This procedure simulates assay
processing and the procedure key cannot be positioned at the
On setting during assay processing.
1890 Processing Module Initialization (i‑series)

Perform this Modules diagnostic procedure to observe the i‑series processing module during an
initialization.

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Reagent and sample manager (RSM) diagnostic procedures

Reagent and sample manager (RSM) diagnostic procedures are grouped in the Sample Manager
category on the Diagnostics tab of the Procedures screen. The operator may need to perform
sample manager diagnostic procedures when RSM components are replaced or when message
codes and observed problems associated with the RSM are diagnosed.

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1600 RSM Transport Calibration, page 917

1610 Reagent and Sample Manager Test, page 917
1620 RSM Bar Code Reader Test, page 918
1635 RSM Transport Test, page 918
1690 Reagent and Sample Manager Initialization, page 919
1600 RSM Transport Calibration

Perform this Sample Manager diagnostic procedure to calibrate the RSM transport to the
following assemblies:
• Sample positioner
• Loading area
Estimated time Variable time based on the number of modules that are
calibrated:
• 12 minutes for one module
• 9 minutes for each additional module

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1610 Reagent and Sample Manager Test

Perform this Sample Manager diagnostic procedure to test the functionality of the following
components:
• RSM transport
• Sample positioner (inner and outer lanes)
• Loading area lights and sensors
Estimated time • 3 minutes for the RSM transport full-function test

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• 1 minute for individual tests
Required materials • Racks

• Reagent cartridge

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1620 RSM Bar Code Reader Test

Perform this Sample Manager diagnostic procedure to test the functionality of the RSM bar code
reader.
Estimated time Variable time based on the number of bar codes that are
scanned
Required materials • Racks
• Bar-coded tubes
• Reagent cartridge

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Procedure key setting System control module: Optional On
1635 RSM Transport Test

Perform this Sample Manager diagnostic procedure to test the functionality of the following RSM
transport components:
• Motors
• Rack pick sensor
• Rack detect sensor

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• Bar code reader
Required materials Sample rack or vial rack

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1690 Reagent and Sample Manager Initialization

Perform this Sample Manager diagnostic procedure to observe the reagent and sample manager
during an initialization.

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Component replacement Section 9
Component replacement
Some system components may need to be replaced because of normal wear from daily system
operation.
The laboratory has a responsibility to maintain an adequate supply of replacement parts. List
numbers are provided in the procedures only for guidance and are subject to change.
When replacing components, comply with the following general safety precautions:
• Dispose of replaced components and materials that are used during component
replacement (for example, absorbent towels or lint-free tissues) according to the laboratory
waste disposal procedures of the facility.
• When drips or leaks occur, clean up the liquid and decontaminate the surface if necessary.
Processing center component replacement (c‑series), page 920
Supply and pump center component replacement (c‑series), page 957
Processing center component replacement (i‑series), page 989
Supply center component replacement (i‑series), page 1008
Optional component replacement, page 1017
Processing center component replacement (c‑series)

Certain processing center components may need to be replaced because of normal wear from
daily system operation. The following illustration shows the location of each replaceable
component. Step-by-step instructions are provided for each replaceable component.

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Section 9 Component replacement
Figure 162: Processing center components (c‑series)
Legend:
1. Sample probe (S)
2. Mixer 2
3. ICT module
4. Lamp
5. Mixer 1
6. Cuvette dry tip
7. Cuvette segment
8. Reagent probe (R1)
9. ICT probe
10. Reagent probe (R2)
Replace the sample probe (c‑series), page 922

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Replace the reagent probes (c‑series), page 925

Replace the sample probe tubing (c‑series), page 930
Replace the reagent probe tubing (c‑series), page 933
Replace the lamp or the lamp plate (c‑series), page 937
Replace the cuvette segments (c‑series), page 941
Replace the cuvette dry tip (c‑series), page 945
Replace the mixers (c‑series), page 948
Replace the sample probe (c‑series)

NOTE: Recording and tracking the date of the sample probe installation is recommended to
ensure that the sample probe is not used for longer than the following intervals:
• Six months for systems that use whole blood assays
• One year for systems that do not use whole blood assays
To replace the sample probe, perform the following procedures:

• Removal, page 923
– Remove the sample probe, page 923
• Replacement, page 924
– Install the sample probe, page 924
• Verification, page 925
– Calibrate the sample pipettor, page 925

• Absorbent towel

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Replacement parts • Sample probe, LN 04S5101
• Sample probe screw, LN 04S5301 (optional)
CAUTION: Probe Stick Hazard. This activity or area may expose you to probes.

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Removal
Remove the sample probe
1. Insert the procedure key into the processing module procedure lock and turn the key to the
On setting.
2. Lift the rear processing center cover to access the sample probe.
3. To move the sample pipettor to the rear of the processing module, initiate Pipettors
diagnostic procedure 4106 Component Move (c‑series), page 879.
4. To remove the sample pipettor cover, gently squeeze the squeeze points to release the
locking tabs and lift the cover.
5. Place an absorbent towel under the probe tip.
6. Use a slotted screwdriver to slightly loosen the probe screw.

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7. Loosen, but do not remove, the probe screw by hand until the probe releases from the
sample pipettor.
8. Loosen, but do not remove, the screw that secures the sample probe grounding wire.
9. Detach the grounding wire.
10. Gently disconnect the tubing from the top of the probe.
Replacement
Install the sample probe
1. Attach the tubing to the top of the new sample probe.

NOTE: Do not flare or stretch the tubing. The tubing needs to fit firmly on the sample probe
but must not be pushed past the bend of the probe so that the tubing does not become too
loose. If the tubing is loose or if the probe has been replaced several times by using the
same tubing, replacing the sample probe tubing is recommended.
2. Position the new sample probe on the alignment pins. Verify that the probe plate is flush
with the plate on the sample pipettor.

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3. Remove the probe screw from the old sample probe and insert the screw into the new
sample probe. Tighten the screw by hand to secure the probe.
4. Stabilize the pipettor and tighten the screw with the slotted screwdriver.
5. Attach the new sample probe grounding wire and tighten the screw.
NOTE: Ensure that the connector for the new sample probe grounding wire is positioned
under the ring-shaped connector.
6. Remove the absorbent towel under the probe tip.
7. To return the sample pipettor to the home position, complete Pipettors diagnostic procedure
4106 Component Move (c‑series), page 879.
8. Perform Fluidics-Wash diagnostic procedure 4205 Flush Water Lines (c‑series), page 882.
While performing the flush, inspect the sample probe for drips and inspect the sample probe
tubing and connections for leaks. If drips or leaks are observed, repeat the installation
procedure.
9. Gently replace the pipettor cover. Ensure that the tubing is not pinched or kinked below the
pipettor cover.
10. Press down on the end of the cover over the pipettor shaft until the cover snaps into
position.
The pipettor cover must be seated completely to ensure correct liquid level sense operation.
Verification
Calibrate the sample pipettor
1. Perform Pipettors diagnostic procedure 4102 Sample Pipettor Calibration (c‑series), page
878.
2. If the system is attached to a laboratory automation system, perform Pipettors diagnostic
procedure 4107 Sample Pipettor LAS Calibration (c‑series), page 879.
4. Turn the procedure key to the Off setting and remove the key from the processing module
procedure lock.
5. Perform quality control testing to verify the system performance before reporting sample
results.
Replace the reagent probes (c‑series)

To replace one or more reagent probes, perform the following procedures:

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– Remove the reagent probe, page 927
– Install the reagent probe, page 928
– Calibrate the reagent pipettor, page 929

• Absorbent towel
Required instrument • Processing module: Idle

status
• Reagent and sample manager: Idle (only if replacing the
R1 probe)

Replacement parts • Reagent probe, LN 04S4901
• Reagent probe screw, LN 04S5401 (optional)

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Removal
Remove the reagent probe
On setting.
2. Lift the appropriate processing center cover:
– To replace the R1 probe, lift the front processing center cover.
– To replace the R2 probe, lift the rear processing center cover.
3. To move the reagent pipettor to the reagent aspiration position, initiate Pipettors diagnostic
procedure 4106 Component Move (c‑series), page 879.
4. To remove the reagent pipettor cover, squeeze the squeeze points to release the locking
tabs and lift the cover.
6. Use a slotted screwdriver to slightly loosen the probe screw.

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7. Loosen, but do not remove, the probe screw by hand until the probe releases from the
reagent pipettor.
8. Loosen, but do not remove, the screw that secures the reagent probe grounding wire.
9. Detach the grounding wire.
Replacement
Install the reagent probe
1. Attach the tubing to the top of the new reagent probe.

NOTE: Do not flare or stretch the tubing. The tubing needs to fit firmly on the reagent probe
loose. If the tubing is loose or if the probe has been replaced several times by using the
same tubing, replacing the reagent probe tubing is recommended.
2. Position the new reagent probe on the alignment pins. Verify that the probe plate is flush
with the plate on the reagent pipettor.

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3. Remove the probe screw from the old reagent probe and insert the screw into the new
reagent probe. Tighten the screw by hand to secure the probe.
4. Stabilize the pipettor and tighten the screw with the slotted screwdriver.
5. Attach the new reagent probe grounding wire and tighten the screw.
NOTE: Ensure that the connector for the new reagent probe grounding wire is positioned
under the ring-shaped connector.
7. To return the reagent pipettor to the home position, complete Pipettors diagnostic procedure
While performing the flush, inspect the reagent probe for drips and inspect the reagent
probe tubing and connections for leaks. If drips or leaks are observed, repeat the installation
procedure.
9. Gently replace the pipettor cover:
– Insert the rear of the pipettor cover into the pipettor and press backward to fully seat
the tabs.
– Align the tabs at the front end of the pipettor cover and press down until the tabs snap
into position.
– Ensure that the tubing is not pinched or kinked below the pipettor cover.
10. Stabilize the pipettor so that it does not drop and damage the probe. Press down on the
middle of the pipettor cover to confirm that it is seated completely.
Verification
Calibrate the reagent pipettor
1. Perform the appropriate Pipettors diagnostic procedure:

– 4103 R1 Pipettor Calibration (c‑series), page 878
– 4104 R2 Pipettor Calibration (c‑series), page 879
2. Close the appropriate processing center cover:
– For the R1 probe, close the front processing center cover.
– For the R2 probe, close the rear processing center cover.
procedure lock.
results.

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Replace the sample probe tubing (c‑series)

To replace the sample probe tubing, perform the following procedures:
– Remove the sample probe tubing, page 931
– Install the sample probe tubing, page 932
– Run quality control samples, page 933

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Replacement parts Sample probe tubing

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Removal
Remove the sample probe tubing
On setting.
2. Lift the rear processing center cover to access the sample probe.
3. To remove the sample pipettor cover, gently squeeze the squeeze points to release the
locking tabs and lift the cover.
4. Unscrew the tubing from the probe tubing connector. Ensure that the black O-ring inside the
tubing connector remains in position.
5. Gently disconnect the tubing from the top of the probe. Use the absorbent towel to absorb
any water from the end of the probe tubing.

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Replacement
Install the sample probe tubing
1. Attach the end of the new tubing to the top of the sample probe.
NOTE: Do not flare or stretch the tubing. The tubing needs to fit firmly on the sample probe
loose.
2. Verify that the black O-ring is inside the probe tubing connector.
3. Screw the opposite end of the tubing into the tubing connector.
While performing the flush, inspect the sample probe for drips and inspect the sample probe
tubing and connections for leaks. If drips or leaks are observed, repeat the installation
procedure.

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5. Gently replace the pipettor cover. Ensure that the tubing is not pinched or kinked below the
pipettor cover.
6. Press down on the end of the cover over the pipettor shaft until the cover snaps into
position.
procedure lock.
Verification
Run quality control samples
Perform quality control testing to verify the system performance before reporting sample results.
Replace the reagent probe tubing (c‑series)

To replace the reagent probe tubing, perform the following procedures:
– Remove the reagent probe tubing, page 934
– Install the reagent probe tubing, page 935

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• Reagent and sample manager: Idle (only if replacing the
R1 probe tubing)

Replacement parts Reagent probe tubing, LN 04S5001

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Removal
Remove the reagent probe tubing
On setting.
– To replace the R1 probe tubing, lift the front processing center cover.

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– To replace the R2 probe tubing, lift the rear processing center cover.
3. To move the reagent pipettor to the reagent aspiration position, initiate Pipettors diagnostic
procedure 4106 Component Move (c‑series), page 879.
5. To remove the reagent pipettor cover, squeeze the squeeze points to release the locking
tabs and lift the cover.
6. Observe the position of the tubing in the routing guides.
8. Gently disconnect the metal connector from the reagent pipettor tubing. Ensure that the
protective sleeve remains on the reagent pipettor tubing.
Replacement
Install the reagent probe tubing

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1. Attach the end of the new tubing with the metal connector to the reagent pipettor tubing.
Verify that the metal connector is inserted into the reagent pipettor tubing and the protective
sleeve.
2. Position the tubing in the routing guides.
3. Attach the other end of new tubing to the reagent probe.
NOTE: Do not flare or stretch the tubing. The tubing needs to fit firmly on the reagent probe
loose.
5. To return the reagent pipettor to the home position, complete Pipettors diagnostic procedure
While performing the flush, inspect the reagent probe for drips and inspect the reagent
probe tubing and connections for leaks. If drips or leaks are observed, repeat the installation
procedure.
7. Gently replace the pipettor cover:
– Insert the rear of the pipettor cover into the pipettor and press backward to fully seat
the tabs.
– Align the tabs at the front end of the pipettor cover and press down until the tabs snap
into position.
– Ensure that the tubing is not pinched or kinked below the pipettor cover.
8. Stabilize the pipettor so that it does not drop and damage the probe. Press down on the
middle of the pipettor cover to confirm that it is seated completely.
– For the R1 probe tubing, close the front processing center cover.
– For the R2 probe tubing, close the rear processing center cover.
procedure lock.
Verification

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Replace the lamp or the lamp plate (c‑series)

To replace the lamp or the lamp plate, perform the following procedures:
– Remove the lamp or lamp plate, page 938
– Install the lamp and the lamp plate, page 940

* This time does not include the 30-minute lamp warm-up
period that is required after replacement.
• 3 mm hex wrench
• Gloves
• Lint-free tissue (optional)
• Ethanol (optional)

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Replacement parts Source lamp, LN 09D4503
To document the lamp change in the maintenance log, perform Quarterly maintenance
procedure 5806 Change Lamp (c‑series), page 862.
CAUTION: Possibility of electric shock. This activity or area may expose you to
electrical shock.
CAUTION: Hot Surface. This activity or area may expose you to hot surfaces.

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Removal
Remove the lamp or lamp plate
1. Power off the processing module by using the main power breaker that is located at the rear
of the module.
NOTE: Do not remove the lamp or the lamp plate when the processing module is powered
on.
2. After turning off the power, wait a minimum of 5 minutes so that the lamp and the lamp
housing can cool.
3. Lift the rear processing center cover.
4. Remove the two screw covers from the rear access panel.
5. Perform one of the following steps to loosen the screws to remove the rear access panel:
– Use the 3 mm hex wrench to loosen the captive hex screws.
– Use the slotted screwdriver to loosen the captive screws.

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6. Remove the rear access panel.

7. Use the slotted screwdriver to loosen the slotted screw on the lamp cover to remove the
cover.
8. Remove the lamp cables from the plastic clamp.
9. Locate the lamp terminal block and lift up both ends of the transparent cover to remove the
cover.
10. Use the Phillips screwdriver to completely loosen the two captive screws that secure the
lamp cables to the lamp terminal block.
11. Raise the screws and lower the lamp cables completely to disengage the cables from the
bottom of the screws.
12. Locate the lamp housing and ensure that it is cool before proceeding to the next step.
13. Completely loosen the tall thumbscrew on the lamp plate. If necessary, use the slotted
screwdriver.
14. Lift the lamp plate out of the lamp housing.
15. Use the slotted screwdriver to loosen the thumbscrew so that the lamp can be removed
from the lamp plate.
16. Remove the lamp and cable from the lamp plate.

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Replacement
Install the lamp and the lamp plate
IMPORTANT: Wear gloves to perform the following steps. Residual oil from an ungloved hand on
the glass surface of the lamp shortens the lamp life. If the glass surface needs to be cleaned,
use lint-free tissue and ethanol.
1. To install the lamp on the lamp plate, align the pins on the lamp plate with the holes on the
new lamp. Ensure that the lamp filament is perpendicular to the lamp plate.
2. With the lamp seated completely on the pins, use the slotted screwdriver to tighten the
screw on the lamp plate.
3. To insert the lamp assembly into the lamp housing, press the assembly against the leaf
spring, and then lower the assembly into the housing. Ensure that the lamp assembly is
seated completely in the lamp housing.
4. Verify that the lamp cables exit the lamp housing through the slot behind the lamp and that
the cables are not pinched by the lamp plate.

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5. Press down on the lamp plate and tighten the thumbscrew to secure the plate to the lamp
housing.
6. On the terminal block, lift the Phillips screws and insert the cables under the screws.
7. Use the Phillips screwdriver to tighten the two captive screws and to secure the two lamp
cables to the terminal block.
8. Replace the transparent cover on the terminal block.
9. Replace the lamp cables in the plastic clamp.
10. Replace the lamp cover and tighten the slotted screw.
11. Install the rear access panel.
12. Perform one of the following steps to secure the rear access panel:
– Use the 3 mm hex wrench to tighten the captive hex screws.
– Use the slotted screwdriver to tighten the captive screws.
13. Replace the two screw covers.
15. Power on the processing module.
NOTE: To ensure the appropriate initialization of the processing module, the system control
module power must be turned on before the processing module power is turned on.
16. Let the lamp warm up for 30 minutes before performing assay processing.
Verification
Replace the cuvette segments (c‑series)

To replace one or more cuvette segments, perform the following procedures:
– Remove the cuvette segment, page 943
– Clean and install the cuvette segment, page 944
– Verify that the cuvette segment is installed correctly, page 945

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Required materials • Detergent A, LN 08P9670
• Lint-free, absorbent towel
• Cotton swabs
• Purified water
• Clean, residue-free container in which to submerge the
cuvette segments
• Gloves

status
Replacement parts Cuvette segment, LN 04S4701

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Removal
Remove the cuvette segment
On setting.
2. Lift the rear processing center cover to access the reaction carousel.
3. Identify the location of the first cuvette segment to replace in the reaction carousel.
4. To rotate the reaction carousel so that the appropriate cuvette segment is located at the
rear of the processing module, perform Reaction Mechanisms diagnostic procedure 5004
Reaction Carousel Home and Move (c‑series), page 890.
5. Use the slotted screwdriver to loosen the slotted screw on the top of the cuvette segment to
remove the segment from the reaction carousel.
6. Dispose of the used cuvette segment.

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7. Repeat steps 4, page 943 through 6, page 943 until all the cuvette segments to replace are
removed.
Replacement
Clean and install the cuvette segment
IMPORTANT: Wear gloves to perform the following steps. Residual oil from an ungloved hand
can cause imprecise optical readings.
1. Remove the new cuvette segment from the shipping container and place the segment on a
lint-free, absorbent towel.
2. Wet a cotton swab with Detergent A and clean the inside and outside of all the cuvettes in
the cuvette segment.
3. Fill a clean, residue-free container with enough purified water to completely submerge the
cuvette segment.
4. Rinse the cuvette segment in the purified water to remove the Detergent A. Drain any
excess purified water from the cuvettes.

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5. Dry the top of the cuvette segment, especially the slotted edges, to remove any remaining
purified water.
6. Position the cuvette segment on the reaction carousel alignment pins.
NOTE: To ensure optimal performance throughout the life span of the c‑series processing
module, the cuvettes need to be replaced after 12 years of use.
7. Tighten the slotted screw by hand on the cuvette segment.
8. Gently tighten the slotted screw with a slotted screwdriver.
9. Repeat steps 1, page 944 through 8, page 945 until all the cuvette segments to replace are
cleaned and are installed.
procedure lock.
Verification
Verify that the cuvette segment is installed correctly
Perform Reaction Mechanisms diagnostic procedure 5004 Reaction Carousel Home and Move
(c‑series), page 890.
Replace the cuvette dry tip (c‑series)

To replace the cuvette dry tip, perform the following procedures:
– Remove the cuvette dry tip, page 946
– Install the cuvette dry tip, page 947
– Wash the cuvettes, page 948

Required materials • Metric ruler
• Gloves

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• Reagent and sample manager: Idle

Replacement parts Cuvette dry tip, LN 04S5201
IMPORTANT: Wear gloves to perform the following steps. Residual oil from an ungloved hand
interferes with the appropriate drying function of the cuvette dry tip.
Removal
Remove the cuvette dry tip

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On setting.
2. Lift the front processing center cover.
3. Loosen the black knurled knob at the left side of the cuvette washer until the cuvette
washer assembly can be lifted from the mounting bracket.
4. Lift the cuvette washer assembly and rotate it so that the white cuvette dry tip can be
accessed easily.
NOTE: The cuvette washer nozzles are attached to the nozzle mounting plate. The screws
that secure the cuvette washer nozzles to the mounting plate do not need to be removed.
5. To remove the cuvette dry tip, pull the tip off the metal nozzle.
6. Dispose of the used cuvette dry tip.
Replacement
Install the cuvette dry tip

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1. Gently install the new cuvette dry tip. Carefully and appropriately orient the cuvette dry tip.
NOTE: The cuvette dry tip and the cuvette are both rectangular in shape. Install the cuvette
dry tip so that it fits into the cuvette.
2. Position the bottom of the cuvette dry tip 61 mm ± 0.5 mm from the underside of the cuvette
washer assembly.
3. Position the cuvette washer assembly on the alignment pins, and then tighten the black
knurled knob.
4. To return the cuvette washer assembly and the reaction carousel to the home position,
perform Fluidics-Wash diagnostic procedure 4207 Move Cuvette Washer (c‑series), page
883.
5. Verify the rectangular orientation and alignment of the cuvette dry tip with the cuvette.
NOTE: If the cuvette dry tip needs to be adjusted, wear gloves. Residual oil from an
ungloved hand interferes with the appropriate drying function of the cuvette dry tip.
6. On the Perform Procedure screen, tap Down to move the cuvette washer assembly
downward.
7. Verify that the cuvette dry tip is correctly aligned and that it moves smoothly into the
cuvettes.
8. To move the cuvette washer assembly upward, tap Up.
9. To end the procedure, tap End Procedure.
10. To complete the procedure, tap Done on the Perform Procedure screen.
11. Close the front processing center cover.
procedure lock.
Verification
Wash the cuvettes
1. Perform As-Needed maintenance procedure 5910 Wash Cuvettes (c‑series), page 867.
results.
Replace the mixers (c‑series)

To replace one or both mixers, perform the following procedures:

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– Remove the mixer, page 950

– Install the mixer, page 951
– Verify the mixer function, page 951

status
• Reagent and sample manager: Idle (only if replacing
mixer 1)

Replacement parts Mixer, LN 09D5903

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Removal
Remove the mixer
On setting.
– To replace mixer 1, lift the front processing center cover.
– To replace mixer 2, lift the rear processing center cover.
3. To unplug the mixer cable, pinch the white connector.
4. Loosen the thumbscrew on the top of the mixer assembly.
5. Remove the mixer.

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Replacement
Install the mixer
1. Align the new mixer so that the flat side faces away from the mixer arm.
2. Align the positioning pins on the top of the mixer with the holes on the mixer arm. Tighten
the thumbscrew until the top of the mixer is flush with the mixer arm.
3. Attach the mixer cable connector to the white connector on the mixer assembly.
NOTE: The mixer cable connector is keyed and can be inserted only one way.
Verification
Verify the mixer function
1. Perform Reaction Mechanisms diagnostic procedure 5002 Mixer Vibration Test (c‑series),
page 889.

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– For mixer 1, close the front processing center cover.
– For mixer 2, close the rear processing center cover.
procedure lock.
results.
Replace the ICT module or the ICT probe (c‑series)

To replace the ICT module or the ICT probe, perform the following procedures:
– Remove the ICT module or the ICT probe, page 953
– Install the ICT module and the ICT probe, page 955
– Calibrate the ICT assays, page 956
Required instrument Processing module: Idle

status
Replacement parts • ICT Module, LN 09D2804
• ICT Probe, LN 09D6304

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Removal
Remove the ICT module or the ICT probe
1. To replace the ICT probe, proceed to step 7, page 954.

2. To replace the ICT module, verify that the new ICT module is within the expiration date on
the ICT module box. Do not use an expired ICT module.
NOTE: When the ICT module is replaced, the c‑series processing module tracks and
maintains a record of the serial number, the expiration date, the warranty sample count, and
the warranty days on the system.
The warranty for the ICT module is 20,000 samples or 3 months after installation, whichever
occurs first.

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5. Use the bar code scanner to scan the two-dimensional (2D) bar code on the Alinity c label
of the new ICT module box.
Under Supply Details in the ICT Module flyout, the system automatically updates the ICT
module with the serial number and expiration date of the new module.
To enter manually the lot number and the expiration date, perform the following steps:
a. Tap Update for the ICT module.
b. Under Supply Details in the ICT Module flyout, enter the serial number and the
expiration date.
NOTE: Entry of the expiration date is optional. If the expiration date is not provided,
expiration tracking for the module is disabled.
c. Tap Replace.
6. When a confirmation message is displayed, perform one of the following steps:
– Tap Yes to continue and confirm that calibrations for all ICT assays are inactivated.
Instructions to replace the ICT module are displayed.
– Tap No to continue without saving the changes. Tap Done to return to the Supplies
screen.
7. Lift the rear processing center cover to access the ICT unit.
8. Loosen the two captive thumbscrews that secure the black plate on the top of the unit.
9. Remove the black plate.
11. Loosen the thumbscrew on the side of the ICT holder until the ICT module can be lifted
upward.
12. To disconnect the black electrical connector from the side of the module, pull the connector
straight out of the module.
13. Verify that the black electrical connector is disconnected completely from the ICT module.
14. Lift the ICT module until the connectors on the side of the ICT module clear the ICT holder.
IMPORTANT: To avoid damage to the ICT probe, do not lift the ICT module and the probe
all the way out of the ICT holder.
15. Gently unscrew the ICT module to disconnect it from the top connector.
16. Lift the ICT module and the ICT probe straight upward and out of the ICT holder.
17. Unscrew the ICT probe holder from the ICT module.
18. Inspect the ports on the ICT module. The yellow O-rings must be present.
IMPORTANT: If the c‑series processing module is run without the yellow O-rings in the
appropriate position, sample results may be adversely affected.
19. If the ICT module will be replaced, dispose of the used module.
If the ICT module will not be replaced, set aside the module for use with the new ICT probe.

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20. Remove the ICT probe from the probe holder.

21. If the ICT probe will be replaced, dispose of the used probe.
If the ICT probe will not be replaced, set aside the probe for use with the new ICT module.
Replacement
Install the ICT module and the ICT probe
1. To replace the ICT module, remove the new ICT module from the box.
2. Disconnect and discard the plastic tubing that is attached to both ends of the ICT module.
3. Inspect the ports on the ICT module. The yellow O-rings must be present.
IMPORTANT: If the system is run without the yellow O-rings in the appropriate position,
sample results may be adversely affected.
4. Align the ICT module so that the gap between the side connectors is on top of the module
and the module label is facing upward and is legible.
5. Place the ICT probe into the ICT probe holder.

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6. If an O-ring from the previous ICT module is attached to the ICT probe, remove the O-ring.
7. Attach the ICT probe holder and ICT probe to the bottom of the ICT module. Do not
overtighten the ICT probe holder.
IMPORTANT: The O-rings may twist and obstruct the flow through the ICT module if the ICT
probe holder connection is overtightened.
8. Insert the ICT module with the ICT probe into the ICT probe holder until the connectors on
the side of the module are located above the top of the holder.
9. Rotate the ICT module to reattach the module to the top port and to the connector. Do not
overtighten the ICT module.
10. If an O-ring from a previous ICT module is attached to the connector, remove the O-ring
before attaching the ICT module.
11. Lower the ICT module until the module is seated completely and the module connectors are
aligned with the slot in the ICT holder.
12. Gently reconnect the black electrical connector to the ICT module connectors. Ensure that
the ICT module is plugged completely into the connector.
13. Press down on the ICT module and simultaneously tighten the side thumbscrew until the
module is secure. Do not overtighten the thumbscrew to prevent damage to the ICT module.
15. To flush the ICT module, perform one of the following steps:
– If the ICT module was replaced, tap Flush ICT in the ICT Module flyout.
– If the ICT probe was replaced, perform ICT diagnostic procedure 5102 Flush ICT
Module (c‑series), page 892.
16. During the flush, perform the following steps:
– Inspect the tubing from the ICT module for bubbles.
– Inspect the ICT probe to ensure that it does not drip.
NOTE: If bubbles or drips are observed, see Processing module observed problems
17. Replace the black plate and tighten the two captive thumbscrews.
18. If the ICT module was replaced, tap Done in the ICT Module flyout.
Verification
Calibrate the ICT assays
1. Perform a calibration for the ICT assays.

2. Perform quality control testing to verify the calibration.

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Supplies screen, Supply Details flyout for ICT Module element descriptions (c‑series), page 569
Supply and pump center component replacement (c‑series)

Certain supply and pump center components may need to be replaced because of normal wear
from daily system operation. The following illustration shows the location of each replaceable
component. Step-by-step instructions are provided for each replaceable component.
Figure 163: Supply and pump center components (c‑series)
Legend:
1. Sample syringe
2. Reagent syringes

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3. Wash solution syringes

4. Wash solution pump syringes (1 mL) and check valves
5. ICT Reference Solution pump syringes (1 mL) and check valves
6. ICT aspiration pump syringes (1 mL) and check valve
Replace the 1 mL syringes (c‑series), page 958
Replace the check valves (c‑series), page 961
Replace the wash solution syringe O-ring and seal tips 1 and 2 (c‑series), page 965
Replace the reagent syringe O-ring and seal tips 1 and 2 (c‑series), page 972
Replace the sample syringe O-ring and seal tips 1 and 2 (c‑series) , page 979
Replace the bulk solution level sensor (c‑series), page 986
Replace the 1 mL syringes (c‑series)

To replace the 1 mL syringes on the ICT Reference Solution pump, the ICT aspiration pump,
and the wash solution pump, perform the following procedures:
– Remove the 1 mL syringe, page 959
– Install the 1 mL syringe, page 960

status
NOTE: The procedure key setting depends on the location of
the 1 mL syringe to be replaced. See step 3 of Remove the
1 mL syringe, page 959.
Replacement parts 1 mL syringe, LN 09D4103
To replace all 1 mL syringes and to document the procedure in the maintenance log, perform
Triannual maintenance procedure 5833 Change 1 mL Syringes (c‑series), page 863.

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Removal
Remove the 1 mL syringe

2. Identify the 1 mL syringe to replace:
– ICT Reference Solution pump
– ICT aspiration pump
– Wash solution pump

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3. If the 1 mL syringe to replace is located on the ICT Reference Solution pump or the ICT
aspiration pump, insert the procedure key into the processing module procedure lock and
turn the key to the On setting.
4. To remove the clear plunger shield from the pump, remove the two black knobs.
5. Pull the 1 mL syringe forward to remove it from the syringe holder.
6. Place an absorbent towel under the pump area to absorb any liquid.
7. Unscrew the syringe assembly from the check valve.
Replacement
Install the 1 mL syringe
1. Screw the new syringe assembly onto the check valve.

2. Install the 1 mL syringe. Ensure that the plunger flange and the bottom of the syringe barrel
are aligned in the syringe holder.

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3. Reinstall the clear plunger shield and secure it with the black knobs. Tighten the black
knobs by hand.
4. Remove the absorbent towel from the pump area.
5. Perform the following diagnostic procedures to remove any air that may be present:
– For the ICT Reference Solution pump and the ICT aspiration pump, perform ICT
diagnostic procedure 5102 Flush ICT Module (c‑series), page 892.
– For the wash solution pump, perform Fluidics-Wash diagnostic procedure 4206 Flush
Bulk Solutions (c‑series), page 883.
6. Inspect the syringe tubing and connections for drips and leaks during the flush. If drips or
leaks are observed, repeat the installation procedure.
7. If the procedure key was turned on, turn the key to the Off setting and remove the key from
the processing module procedure lock.
Verification
Replace the check valves (c‑series)

To replace the check valves on the ICT Reference Solution pump, the ICT aspiration pump, or
the wash solution pump, perform the following procedures:
– Remove the check valve, page 963
– Install the check valve, page 964

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NOTE: The procedure key setting depends on the location of
the check valve to be replaced. See step 3 of Remove the
check valve, page 963.
Replacement parts • ICT Check Valve, LN 09D3503
• Wash Solution Check Valve, LN 09D3403
To replace the ICT check valves and to document the procedure in the maintenance log,
perform Triannual maintenance procedure 5834 Check and Change ICT Check Valves (c‑series),
page 864.

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Removal
Remove the check valve

2. Identify the check valve to replace:
– ICT Reference Solution check valve
– ICT aspiration check valve
– Wash solution check valve
3. To replace one of the ICT check valves, insert the procedure key into the processing
module procedure lock and turn the key to the On setting.
4. To remove the clear plunger shield from the pump, remove the two black knobs.
5. Pull the 1 mL syringe forward to remove it from the syringe holder.
6. Place an absorbent towel under the pump area to absorb any liquid.

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7. Disconnect the top and side tubing from the check valve.
8. Unscrew the check valve from the syringe.
Replacement
Install the check valve
1. Install the new check valve onto the syringe and tighten the valve by hand.
2. Reattach the tubing to the side and top ports on the check valve and tighten the tubing by
hand.
3. Install the syringe. Ensure that the plunger flange and the bottom of the syringe barrel are
aligned in the syringe holder.
4. Remove the absorbent towel from the pump area.
5. Reinstall the clear plunger shield and secure it with the black knobs. Tighten the black
knobs by hand.
6. Perform the following diagnostic procedures to remove any air that may be present:

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– For the ICT Reference Solution pump and the ICT aspiration pump, perform ICT
diagnostic procedure 5102 Flush ICT Module (c‑series), page 892.
– For the wash solution pump, perform Fluidics-Wash diagnostic procedure 4206 Flush
Bulk Solutions (c‑series), page 883.
7. Inspect the syringe tubing and check valve connections for drips and leaks during the flush.
If drips or leaks are observed, repeat the installation procedure.
8. If the procedure key was turned on, turn the key to the Off setting and remove the key from
the processing module procedure lock.
Verification
Replace the wash solution syringe O-ring and seal tips 1 and 2 (c‑series)
To replace the wash solution syringe O-ring and seal tips 1 and 2, perform the following
procedures:
– Remove the wash solution syringe, page 967
– Remove the seal tips and the O-ring, page 968
– Install the seal tips and the O-ring, page 970
– Install the wash solution syringe, page 971

• 10 mm wrench

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• Cotton swabs

status
Replacement parts • Sample and Wash Solution Syringe O-ring, LN 09D5203
09D3703
09D3803
To replace the O-rings and seal tips for both wash solution syringes and to document the
procedure in the maintenance log, perform Quarterly maintenance procedure 5802 Wash
Solution Syringe Maintenance (c‑series), page 861.

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Removal
Remove the wash solution syringe
1. Open the bulk solution door and locate the wash solution pump.
2. Unscrew the two black knobs to remove the clear plastic plunger shield.
3. Pull the three 1 mL syringes forward to remove them from the white syringe holder. Do not
disconnect the tubing from the syringes.
4. Place the three 1 mL syringes to the left side of the white syringe holder.
5. Use the Phillips screwdriver to unscrew the two Phillips screws to remove the white syringe
holder.
6. Use the slotted screwdriver to loosen the slotted screw that secures the clear syringe block.
NOTE: The screw is captive and cannot be removed completely.
7. Pull the clear syringe block forward to remove it from the syringe drive.

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8. Place absorbent towels under the clear syringe block to absorb any liquid when the tubing is
disconnected.
9. Disconnect the tubing labeled 2 and labeled 3 from the top and front of the clear syringe
block.
NOTE: Ensure that the black O-rings remain in the clear syringe block after the tubing is
disconnected.
10. Identify the wash solution syringe for which the O-ring and seal tips will be replaced.
Remove the seal tips and the O-ring
1. Use the 10 mm wrench to loosen the nut that secures the syringe plunger to the bottom of
the clear syringe block.
2. Turn the nut by hand until the syringe plunger can be removed from the clear syringe block.
The plunger assembly includes the following parts in order:
a. O-ring
b. Seal tip 2

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c. Spacer
d. Seal tip 1
e. Spring
f. Nut
g. Plunger with the plunger flange
The O-ring can remain in the syringe when the plunger assembly is removed.
3. Remove and discard the following items:
– O-ring
– Seal tip 2
– Seal tip 1
NOTE: Do not discard the spacer. Set aside the spacer and the remainder of the plunger
assembly parts.
Do not remove the spring from the nut.
4. Dry the interior of the syringe barrel with a cotton swab. Dry the plunger completely with an
absorbent towel if liquid is present.

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Replacement
Install the seal tips and the O-ring
1. Install seal tip 1 on the plunger so that the seal tip sits above the spring with the open side
away from the spring.
2. Install the spacer so that it fits into the open side of seal tip 1.
3. Install seal tip 2 on top of the spacer with the open side toward the spacer.
4. Install the O-ring so that it fits into the groove of seal tip 2. Do not push the O-ring out of
alignment. The O-ring must sit flat against the inside of the clear syringe block.
5. Press lightly to push all the components together.
6. Install the plunger assembly into the clear syringe block.
7. Tighten by hand the nut that holds the plunger assembly in the clear syringe block until the
nut is tight.

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NOTE: The nut must be flush with the clear syringe block. If the nut binds when tightening it,
do not apply excessive force. Back out the nut one turn. Then, push in the nut to apply
pressure against the spring and continue to tighten the nut.
8. Use the 10 mm wrench to further tighten the nut, but do not overtighten it.
Install the wash solution syringe
1. Ensure that the black O-rings remain in the clear syringe block.
2. Reattach the knurled connection for the tubing labeled 2 to the top left opening of the clear
syringe block.
3. Reattach the knurled connection for the tubing labeled 3 to the top right opening of the clear
syringe block.
4. Reattach the knurled connection for the tubing labeled 2 from the 1 mL syringe to the front
left opening of the clear syringe block.
5. Reattach the knurled connection for the tubing labeled 3 from the 1 mL syringe to the front
right opening of the clear syringe block.

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6. Remove the absorbent towels under the clear syringe block.

7. Place the wash solution syringe block on the alignment pins and tighten the slotted screw by
hand until the screw is tight.
8. Further tighten the slotted screw with the slotted screwdriver.
9. Ensure that the plunger flanges are seated on the metal block beneath the syringes.
10. Replace the white syringe holder and tighten the two Phillips screws with the Phillips
screwdriver.
11. Verify that the 1 mL syringe tubing connections did not loosen during the removal and
replacement procedure.
12. Reinstall the 1 mL syringes into the syringe holder in the following order:
a. Place the 1 mL syringe with tubing labeled 2 in the left syringe holder position.
b. Place the 1 mL syringe with no tubing label in the center syringe holder position.
c. Place the 1 mL syringe with tubing labeled 3 in the right syringe holder position.
13. Ensure that the 1 mL syringe plunger flanges and the bottom of the syringe barrels are
aligned in the syringe holder.
14. Attach the clear plastic plunger shield and tighten the two black knobs by hand.
15. To remove any air that may be present, perform Fluidics-Wash diagnostic procedure 4205
Flush Water Lines (c‑series), page 882.
Verification
Replace the reagent syringe O-ring and seal tips 1 and 2 (c‑series)
To replace the reagent syringe O-ring and seal tips 1 and 2, perform the following procedures:
– Remove the reagent syringe, page 974

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– Install the reagent syringe, page 978

• 15 mm wrench
• Cotton swabs

status
Replacement parts • Reagent syringe O-ring, LN 09D5303
To replace the O-rings and seal tips for both the R1 and R2 reagent syringes and to document
the procedure in the maintenance log, perform Quarterly maintenance procedure 5803 Reagent
Syringe Maintenance (c‑series), page 862.

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Removal
Remove the reagent syringe
1. Open the bulk solution door and locate the syringe cover for the sample and reagent
syringes.
2. Remove the sample and reagent syringe tubing from the clamps on the syringe cover.
3. Use the Phillips screwdriver to loosen the two Phillips screws enough to pull the cover away
from the syringes.
4. Identify the reagent syringe for which the O-rings and seal tips will be replaced.
5. Use the slotted screwdriver to loosen the slotted screw that secures the syringe block. Do
not attempt to remove the syringe block.
6. Use the slotted screwdriver to loosen the slotted screw that holds the syringe bracket over
the syringe plunger. Do not remove the screw or the syringe bracket.
7. Pull the reagent syringe away from the syringe drive and the syringe bracket.

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8. Place an absorbent towel under the reagent syringe to absorb any liquid.
9. Unscrew the knurled connections at the top and side of the syringe block to disconnect the
tubing.
NOTE: Ensure that the black O-rings remain in the syringe block after the tubing is
disconnected.
the syringe block.
2. Turn the nut by hand until the syringe plunger can be removed from the syringe block.
a. O-ring
b. Seal tip 2
c. Spacer

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d. Seal tip 1
e. Spring
f. Nut
– O-ring
– Seal tip 2
– Seal tip 1
assembly parts.

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Replacement
alignment. The O-ring must sit flat against the inside of the syringe block.
6. Install the plunger assembly into the syringe block.
7. Tighten by hand the nut that holds the plunger assembly in the syringe block until the nut is
tight.

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NOTE: The nut must be flush with the syringe block. If the nut binds when tightening it, do
not apply excessive force. Back out the nut one turn. Then, push in the nut to apply
Install the reagent syringe
1. Ensure that the black O-rings remain in the syringe block.

2. Reattach the knurled connections at the top and side of the syringe block to connect the
tubing.
3. Remove the absorbent towel from the syringe drive area.
4. Insert the plunger flange into the syringe bracket. Align the reagent syringe block with the
pin on the syringe drive.
5. Push the reagent syringe block onto the syringe drive. Ensure that the syringe plunger is
pushed back into the U-shape of the syringe bracket.

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6. Place the syringe block on the alignment pin and tighten the slotted screw by hand until the
screw is tight.
8. Use the slotted screwdriver to tighten the slotted screw that holds the syringe bracket to the
syringe drive.
9. Replace the syringe cover and tighten the two Phillips screws with the Phillips screwdriver.
10. Replace the sample and reagent syringe tubing in the clamps on the syringe cover.
Verification
Replace the sample syringe O-ring and seal tips 1 and 2 (c‑series)
To replace the sample syringe O-ring and seal tips 1 and 2, perform the following procedures:
– Remove the sample syringe, page 981
– Install the sample syringe, page 985


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• 10 mm wrench
• Cotton swabs

status
Replacement parts • Sample and Wash Solution Syringe O-ring, LN 09D5203
09D3703
09D3803
To replace the O-ring and seal tips for the sample syringe and to document the procedure in the
maintenance log, perform Quarterly maintenance procedure 5801 Sample Syringe Maintenance

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Removal
Remove the sample syringe
1. Open the bulk solution door and locate the syringe cover for the sample and reagent
syringes.
2. Remove the sample and reagent syringe tubing from the clamps on the syringe cover.
3. Use the Phillips screwdriver to loosen the two Phillips screws enough to pull the cover away
from the syringes.
4. Identify the sample syringe.
5. Use the slotted screwdriver to loosen the slotted screw that secures the syringe block. Do
not attempt to remove the syringe block.
6. Use the slotted screwdriver to loosen the slotted screw that holds the syringe bracket over
the syringe plunger. Do not remove the screw or the syringe bracket.
7. Pull the sample syringe away from the syringe drive and the syringe bracket.

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8. Place an absorbent towel under the sample syringe to absorb any liquid.
9. Unscrew the knurled connections at the top and side of the syringe block to disconnect the
tubing.
NOTE: Ensure that the black O-rings remain in the syringe block after the tubing is
disconnected.
the syringe block.
2. Turn the nut by hand until the syringe plunger can be removed from the syringe block.
a. O-ring
b. Seal tip 2
c. Spacer

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d. Seal tip 1
e. Spring
f. Nut
– O-ring
– Seal tip 2
– Seal tip 1
assembly parts.

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Replacement
alignment. The O-ring must sit flat against the inside of the syringe block.
6. Install the plunger assembly into the syringe block.
7. Tighten by hand the nut that holds the plunger assembly in the syringe block until the nut is
tight.

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NOTE: The nut must be flush with the syringe block. If the nut binds when tightening it, do
not apply excessive force. Back out the nut one turn. Then, push in the nut to apply
Install the sample syringe
1. Ensure that the black O-rings remain in the syringe block.

2. Reattach the knurled connections at the top and side of the syringe block to connect the
tubing.
3. Remove the absorbent towel from the syringe drive area.
4. Insert the plunger flange into the syringe bracket. Align the sample syringe block with the pin
on the syringe drive.
5. Push the sample syringe block onto the syringe drive. Ensure that the syringe plunger is
pushed back into the U-shape of the bracket.

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6. Place the syringe block on the alignment pin and tighten the slotted screw by hand until the
screw is tight.
8. Use the slotted screwdriver to tighten the slotted screw that holds the syringe bracket to the
syringe drive.
9. Replace the syringe cover and tighten the two Phillips screws with the Phillips screwdriver.
10. Replace the sample and reagent syringe tubing in the clamps on the syringe cover.
Verification
Replace the bulk solution level sensor (c‑series)

To replace the level sensor for Acid Wash, Alkaline Wash or ICT Reference Solution, perform
the following procedures:
– Remove the bulk solution level sensor, page 987
– Install the bulk solution level sensor, page 988
– Verify the functionality of the bulk solution level sensors, page 989

status

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Replacement parts Level sensor, bulk solution, LN 04S6801
IMPORTANT: To ensure that the correct tubing and connections are used for the bulk solution
level sensors, replace one level sensor at a time.
Removal
Remove the bulk solution level sensor
1. Open the bulk solution door and pull out the reservoir tray.
NOTE: Use caution when handling the bulk solution level sensors. Avoid applying stress on
the wiring and connector.
2. Disconnect the electrical connector from the appropriate bulk solution level sensor.
3. Use an absorbent towel to absorb any spills.

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4. Unscrew the two tubing fittings from the bulk solution level sensor.
5. Unscrew the bulk solution level sensor cap.
6. Remove the bulk solution level sensor from the reservoir.
Replacement
Install the bulk solution level sensor
1. Place the bulk solution level sensor into the container.

2. Tighten the bulk solution level sensor cap.
3. Connect the tubing from the bulk solution transfer pump to the input connector (labeled with
an arrow that points toward the connector) on the bulk solution level sensor.
4. Connect the tubing from the syringe pump to the output connector (labeled with an arrow
that points away from the connector) on the bulk solution level sensor.
5. Verify that both tubing connectors are tightened completely.
6. Connect the electrical connector of the bulk solution level sensor.

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7. Start the processing module.

Flush Bulk Solutions (c‑series), page 883.
While performing the flush, inspect the tubing and connections of the bulk solution level
sensor for drips and leaks. If drips or leaks are observed, repeat the installation procedure.
9. Slide the reservoir bottle tray into the bulk solution reservoir area and close the bulk solution
door.
Verification
Verify the functionality of the bulk solution level sensors
Perform Fluidics-Wash diagnostic procedure 4212 Bulk Solution Sensor Test (c‑series), page
884.
Processing center component replacement (i‑series)

Certain processing center components may need to be replaced because of normal wear from
daily system operation. The following illustration shows the location of each replaceable
component. Step-by-step instructions are provided for each replaceable components.

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Figure 164: Processing center components (i‑series)
Legend:
1. Sample pipettor probe (S)
2. Reagent pipettor probe (R2)
3. Wash zone 1 probes (WZ1)
4. Liquid waste arm probe
5. Reagent pipettor probe (R1)
6. Wash zone 2 probes (WZ2)
Removal and replacement of the process path light cover (i‑series), page 991
Replace a sample or reagent pipettor probe (i‑series), page 998
Replace the wash zone probes (i‑series), page 1001
Replace the liquid waste arm probe (i‑series), page 1005

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Removal and replacement of the process path light cover (i‑series)

The process path light cover on the process path prevents external light interference with the
diverter sensors and the optics. The cover must be removed to access the RV unloader and the
waste aspirate probe. One of two configurations will be installed on the system. Determine the
configuration that is installed on the Alinity i. Then, refer to the appropriate removal and
replacement procedure.
Figure 165: Process path light cover configurations (i‑series)
Legend:
1. One-piece process path light cover
2. Two-piece process path light cover
Remove and replace the one-piece process path light cover (i‑series), page 992
Remove and replace the two-piece process path light cover (i‑series), page 995

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Remove and replace the one-piece process path light cover (i‑series)
To remove and replace the one-piece process path light cover, perform the following
procedures:
– Remove the process path light cover, page 993
– Install the process path light cover, page 994
– Initialize the processing module, page 995

status
CAUTION: Moving Parts. This activity or area may expose you to moving parts.

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Removal
Remove the process path light cover
1. Open the front processing center cover to access the process path light cover.
2. Gently pull the process path light cover straight up and out of the processing center. Be
sure to clear the waste aspirate probe.

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Replacement
Install the process path light cover
1. Place the front right corner of the process path light cover directly in front of the knurled
screw, near the STAT diverter (STD), on the process path.
2. Align the cables and tubing with the small notches at the bottom of the process path light
cover.
3. Open the rear processing center cover.
4. Verify that the process path light cover is seated completely on the process path.

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Verification
Initialize the processing module
1. Perform Modules diagnostic procedure 1890 Processing Module Initialization (i‑series), page
916.
2. While the processing module initializes, verify that the waste aspirate probe does not
interfere with the process path light cover.
3. Close the front and rear processing center covers.
Replace the liquid waste arm probe (i‑series), page 1005
Remove and replace the two-piece process path light cover (i‑series)
To remove and replace the RV unloader access piece of the two-piece process path light cover,
perform the following procedures:
– Remove the RV unloader access piece of the process path light cover, page 996
– Install the RV unloader access piece of the process path light cover, page 997
– Initialize the processing module, page 997

status

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Removal
Remove the RV unloader access piece of the process path light cover
1. Open the rear or front processing center cover to access the process path light cover.
2. Gently pull the RV unloader access piece of the process path light cover upward to remove
the RV unloader access piece. Set aside the RV unloader access piece.
NOTE: To access the RV unloader or the waste aspirate probe, the unload access sensor
does not need to be disconnected.

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Replacement
Install the RV unloader access piece of the process path light cover
1. Place the guides on the right and left sides of the RV unloader access piece of the process
path light cover into the slots on the second piece of the cover, which is secured to the
process path.
2. Verify that the RV unloader access piece is seated completely on the second piece of the
process path light cover.
Verification
Initialize the processing module
1. Perform Modules diagnostic procedure 1890 Processing Module Initialization (i‑series), page
916.

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2. While the processing module initializes, verify that the RV unloader access piece does not
interfere with the waste aspirate probe.
Replace a sample or reagent pipettor probe (i‑series)

To replace a sample or reagent pipettor probe, perform the following procedures:
– Remove the pipettor probe, page 999
– Install the pipettor probe, page 1000
– Perform a pipettor probe calibration, page 1001

status
Replacement parts Pipettor Probe, LN 03R9601

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Removal
Remove the pipettor probe
On setting.
2. Lift the rear processing center cover to access the pipettor probe.
3. Initiate Pipettors diagnostic procedure 1161 Pipettor Probe Move (i‑series), page 901 to
move the pipettor probes to an appropriate position for component replacement.
4. If replacing the sample pipettor probe, place an absorbent towel on the process path under
the probe.
5. Place an absorbent towel under the probe tubing connection.
6. Loosen the metal fitting on the probe and remove the probe tubing from the probe.
7. Rotate the probe retainer counterclockwise until it clears the probe.
8. Lift the probe and remove it from the boom arm.

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Replacement
Install the pipettor probe
1. Slide the pipettor probe into the boom arm.

2. Rotate the probe retainer clockwise until the probe is secured.
3. Align the probe tubing with the probe and tighten the probe fitting by hand.
4. Remove the absorbent towels.
5. Complete Pipettors diagnostic procedure 1161 Pipettor Probe Move (i‑series), page 901.
Flush and Prime Fluidics (i‑series), page 902, Flush Wash Buffer, All option.
While performing the flush, inspect the probe for drips and inspect the probe tubing and
connections for leaks. If drips or leaks are observed, repeat the installation procedure.

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Verification
Perform a pipettor probe calibration
1. Perform the appropriate Pipettors diagnostic procedure:

– 1111 Sample Pipettor Check and Calibration (i‑series), page 895
– 1112 R1 Pipettor Check and Calibration (i‑series), page 895
– 1113 R2 Pipettor Check and Calibration (i‑series), page 896
2. If the system is attached to a laboratory automation system and the sample pipettor probe
was replaced, perform Pipettors diagnostic procedure 1115 Sample Pipettor LAS Calibration
(i‑series), page 896.
procedure lock.
Replace the wash zone probes (i‑series)

To replace one or more wash zone probes, perform the following procedures:
– Remove the wash zone probe, page 1002
– Install the wash zone probe, page 1004
– Calibrate and test the wash monitoring, page 1005

status
Replacement parts Wash Zone Probe, LN 08C9436

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Removal
Remove the wash zone probe
On setting.
2. Lift the rear processing center cover to access the wash zone probes.
3. Locate the wash zone probe to replace on the appropriate wash zone.

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4. To disconnect the electrical connector from the WZ ASP cable, press the connector tab and
pull apart the electrical connector and the connector tab.
5. Unscrew the thumbscrew that secures the probe block assembly to the wash zone elevator
assembly.
6. Lift the probe block assembly to access the wash zone probe tubing.
7. To disconnect the wash zone probe tubing from the wash zone probes, gently pull the tubing
and slide it off each probe.
8. Invert the probe block assembly so that the wash zone probes are facing upward.
9. Unscrew the two thumbscrews that secure the wash zone monitor housing (black) to the
probe housing (blue). Do not disconnect the two assemblies.
10. With the wash zone monitor housing and the probe housing still connected, invert the probe
block assembly so that the wash zone probes are facing downward.
11. Disconnect the wash zone monitor housing from the probe housing.
12. Remove the wash zone probe.

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Replacement
Install the wash zone probe
1. Slide the wash zone probe into the probe housing (blue).
2. Align the L-shaped cutout of the wash zone monitor housing (black) with the L-shaped
cutout of the probe housing. Guide the wash zone probes into the probe channel in the
wash zone monitor housing.
3. With the wash zone monitor housing and the probe housing connected, invert the probe
block assembly so that the wash zone probes are facing upward.
4. Tighten the two thumbscrews that secure the wash zone monitor housing to the probe
housing.
5. Push the wash zone probe tubing onto the wash zone probe until the tubing passes the ridge
on the probe.
NOTE: Position the tubing halfway between the bend and the ridge of the probe.

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6. To install the probe block assembly on the wash zone elevator assembly, align the holes on
the probe block assembly with the pins on the wash zone elevator assembly.
7. Tighten the thumbscrew that secures the probe block assembly to the wash zone elevator
assembly.
8. To reconnect the electrical connector to the WZ ASP cable, align the notch on the electrical
connector with the connector tab.
Verification
Calibrate and test the wash monitoring
Perform the appropriate Fluidics-Wash diagnostic procedure:

• 1261 Wash Zone 1 Wash Monitoring (i‑series), page 908, Calibrate and Test option
• 1262 Wash Zone 2 Wash Monitoring (i‑series), page 908, Calibrate and Test option
Replace the liquid waste arm probe (i‑series)

To replace the waste arm probe, perform the following procedures:
– Remove the liquid waste arm probe, page 1006
– Install the liquid waste arm probe, page 1007
– Perform a wash zone prime, page 1008

status
Replacement parts Wash Zone Probe, LN 08C9436

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Removal
Remove the liquid waste arm probe
On setting.
2. Lift the front processing center cover to access the liquid waste arm probe.
3. Remove the process path light cover.
4. Remove the liquid waste arm probe tubing from the tubing clip on the liquid waste arm.
5. Lift the probe and remove it from the front of the liquid waste arm.

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6. To disconnect the liquid waste arm probe tubing from the probe, gently pull the tubing and
slide it off the probe.
Replacement
Install the liquid waste arm probe
1. Push the liquid waste arm probe tubing onto the liquid waste arm probe until the tubing
passes the ridge on the probe.
NOTE: Position the tubing halfway between the bend and the ridge of the probe.
2. Slide the probe into the front of the liquid waste arm until the probe is seated completely.
3. Insert the liquid waste arm probe tubing into the tubing clip on the liquid waste arm.

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Verification
Perform a wash zone prime
1. Perform Fluidics-Wash diagnostic procedure 1200 Flush and Prime Fluidics (i‑series), page
902, Flush and Prime Manifolds, Wash Zone 1 option.
While performing the prime, observe the liquid waste arm probe tubing and confirm that
liquid is dispensed through the tubing.
2. Replace the process path light cover.
procedure lock.
Remove and replace the one-piece process path light cover (i‑series), page 992
Supply center component replacement (i‑series)

Certain supply center components may need to be replaced because of normal wear from daily
system operation. The following illustration shows the location of each replaceable component.
Step-by-step instructions are provided for each replaceable component.

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Figure 166: Bulk solution reservoir components (i‑series)
Legend:
1. Concentrated Wash Buffer level sensor
2. Trigger Solution level sensor
3. Pre-Trigger Solution level sensor

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Figure 167: Pump drawer component (i‑series)
Legend:
1. Diluted wash buffer level sensor
Replace the level sensor for Pre-Trigger Solution, Trigger Solution, or Concentrated Wash Buffer
(i‑series), page 1010
Replace the diluted wash buffer level sensor (i‑series), page 1014
Replace the level sensor for Pre-Trigger Solution, Trigger Solution, or Concentrated Wash
Buffer (i‑series)
To replace the level sensor for Pre-Trigger Solution, Trigger Solution, or Concentrated Wash
Buffer, perform the following procedures:
– Remove the bulk solution level sensor, page 1012

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– Install the bulk solution level sensor, page 1013
– Verify the functionality of the bulk solution level sensors, page 1014

status
Replacement parts Level sensor, bulk solution, LN 04S6801
level sensors, replace one level sensor at a time.

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Removal
Remove the bulk solution level sensor
3. Use an absorbent towel to absorb any spills.

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Replacement
Install the bulk solution level sensor

Flush and Prime Fluidics (i‑series), page 902 for the appropriate bulk solution.

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Perform one of the following procedure options:

– Flush Pre-Trigger and Trigger
– Prime Dilution Assembly
door.
Verification
Verify the functionality of the bulk solution level sensors
Perform Fluidics-Wash diagnostic procedure 1270 Bulk Solutions Motors and Sensors Test
(i‑series), page 909, Read All Sensors option.
Replace the diluted wash buffer level sensor (i‑series)

To replace the level sensor for the diluted wash buffer, perform the following procedures:
– Remove the diluted wash buffer level sensor, page 1015
– Install the diluted wash buffer level sensor, page 1016
– Verify the functionality of the diluted wash buffer level sensor, page 1017

Required materials • Absorbent tissue
• Lock ring release tool

status
Replacement parts Level Sensor, Diluted Wash Buffer, LN 04S6901

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Removal
Remove the diluted wash buffer level sensor
1. Remove the rear fluidics panel and pull out the pump drawer.
NOTE: Use caution when handling the diluted wash buffer level sensor. Avoid applying
stress on the wiring and connector.
2. Disconnect the electrical connector from the diluted wash buffer level sensor.
3. Use absorbent tissue to absorb any spills.

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4. Insert the lock ring release tool between the tube fitting and the diluted wash buffer level
sensor.
5. Press the lock ring release tool toward the diluted wash buffer level sensor and pull the
tubing straight out of the level sensor.
6. Repeat steps 4, page 1016 and 5, page 1016 to remove the remaining tubing.
7. Unscrew the diluted wash buffer level sensor cap.
8. Remove the diluted wash buffer level sensor from the reservoir.
Replacement
Install the diluted wash buffer level sensor
1. Place the diluted wash buffer level sensor into the container.
2. Tighten the diluted wash buffer level sensor cap.

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3. Connect the tubing from the buffer waste valve (located at the top of the dilution assembly
tray) to the input connector (labeled with an arrow that points toward the connector) on the
diluted wash buffer level sensor.
4. Align the tubing connector with the fitting and press the connector straight into the fitting.
5. Connect the tubing from the manifold in the pump drawer to the output connector (labeled
with an arrow that points away from the connector) on the diluted wash buffer level sensor.
7. Slightly pull the connector to confirm that it is connected completely.
8. Connect the electrical connector of the diluted wash buffer level sensor.
Flush and Prime Fluidics (i‑series), page 902, Flush Wash Buffer option.
While performing the flush, inspect the tubing and connections of the diluted wash buffer
level sensor for drips and leaks. If drips or leaks are observed, repeat the installation
procedure.
11. Slide the pump drawer into the rear fluidics area and replace the rear fluidics panel.
Verification
Verify the functionality of the diluted wash buffer level sensor
Perform Fluidics-Wash diagnostic procedure 1270 Bulk Solutions Motors and Sensors Test
(i‑series), page 909, Read All Sensors option.
Optional component replacement

Certain optional components may need to be replaced because of normal wear from daily
system operation.
Step-by-step instructions are provided for each replaceable component.
Replace the external waste pump, page 1017
Replace the external waste pump

To replace the external waste pump, perform the following procedures:

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– Remove the external waste pump, page 1019
– Install the external waste pump, page 1020
– Perform a flush procedure, page 1021

status
Replacement parts External Waste Pump, LN 04S7401

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Removal
Remove the external waste pump
1. Power off the external waste pump.

2. Unplug the power cord from the external waste pump.
3. Disconnect the waste outlet quick disconnect.
4. Disconnect the inlet quick disconnect.

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Replacement
Install the external waste pump
1. Move the voltage switch on the external waste pump assembly to the correct position (115 V
or 230 V) according to the voltage requirements of the country.
2. Attach the power cord.
3. Connect the inlet lines.
4. Connect the outlet waste line.
5. Power on the external waste pump.
6. Press and hold the manual operation switch until the pump turns on.
7. Release the manual operation switch to leave the pump in Automatic mode.

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Verification
Perform a flush procedure
Perform the appropriate Fluidics-Wash diagnostic procedure consecutive times to verify that the
external waste pump turns on and transports the waste fluid to the drain:
• 4205 Flush Water Lines (c‑series), page 882
• 1200 Flush and Prime Fluidics (i‑series), page 902, Flush Wash Buffer, All option
Optional component replacement, page 1017

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NOTES

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Section 10 Troubleshooting
Introduction
Problems with the Alinity ci‑series are characterized by symptoms. Troubleshooting tools,
references, and suggested techniques help to trace the symptom to one or more root causes.
After determining the root cause, perform the corrective actions to resolve the problem.
Approach to troubleshooting, page 1024
Alert Center flyout, page 1033
System Logs screen, page 1036
Message codes, page 1051
Observed problems, page 1417
Miscellaneous corrective action procedures, page 1449

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Troubleshooting
Approach to troubleshooting Section 10
Approach to troubleshooting
To identify and resolve operational problems, become thoroughly familiar with normal system
operation. Effective troubleshooting requires a logical, step-by-step approach to resolve
problems. This approach focuses on the following activities:
• Observation, recognition, and categorization of symptoms
• Identification of the probable cause
• Systematic elimination of each potential problem (from the most likely problem to the least
likely problem)
The following troubleshooting model describes a five-step approach to define symptoms, identify
problems, and implement solutions. To troubleshoot the system, include considerations that are
appropriate to the laboratory environment.
1. Observe and recognize symptoms.
To analyze and resolve a problem, investigate what is incorrect and observe what is correct.
Symptoms help to identify the problem area and to eliminate areas that operate correctly.
Examples of symptoms include:
– Message codes.
– Observed problems such as a noise, a fluid leak, a monitor that flickers, or a trend in
controls.
2. Categorize symptoms.
To eliminate symptoms automatically as probable causes, classify symptoms by categories.
Categories of symptoms include:
– System
– Reagents
– Operator
– Environmental
3. Isolate the root cause and create a plan of action.
Based on the probable causes that are identified, devise a plan that first addresses the most
likely cause and then progresses to the least likely cause.
Address one probable cause at a time to isolate the resolution, and then apply the resolution
to a specific problem. Diagnostic resources and tools include:
– Message codes and messages.
– System logs.
– Control information.
– Maintenance and diagnostic procedures.

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Troubleshooting
Section 10 Approach to troubleshooting
– This manual or the Help. Specific reference topics include the following sections in this
manual:
• Troubleshooting
• Service, maintenance, and diagnostics
• Performance characteristics and specifications
• Principles of operation
– The product documentation such as reagent and consumable information.
4. Resolve the problem.
Carefully perform the required steps to resolve the problem. Problems can be resolved by
the following actions:
– Make adjustments, such as tighten connections.
– Perform a calibration.
– Replace or repair system components.
– Run new controls.
5. Verify that the resolution worked.
Verify that symptoms do not occur:
– Perform the appropriate verification procedure.
– Confirm control values if appropriate.
If symptoms continue to occur, perform the steps to resolve the next most likely problem. Repeat
this process until the problem is resolved.
System troubleshooting variables (c‑series), page 1025
System troubleshooting variables (i‑series), page 1027
Reagent troubleshooting variables (c‑series), page 1029
Reagent troubleshooting variables (i‑series), page 1030
Operator troubleshooting variables, page 1031
Environmental troubleshooting variables, page 1032
System troubleshooting variables (c‑series)

The system category is a high-level group of symptoms that relate to system performance. This
category contains more specific subcategories or variables. Trace an error or a problem to one
of these variables to begin to isolate the probable cause.

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Troubleshooting
Fluidics subsystems
Fluidics subsystems are hardware components that control the precision and accuracy of liquid
level sensing, aspiration, and dispense. In addition, these components distribute the fluids used
to wash the probes:
Examples • Pipettors and probes
• Pressure monitors
• Syringes and valves
• Tubing
• Processing module circuit boards
• Pumps
• ICT unit
Symptoms • LLS and fluidics message codes (3000-3999)

• Imprecise results or erratic results
Optical subsystem
The optical subsystem has hardware components that control concise and accurate optical
readings:
Examples • Lamp
• Heat absorbing filter
• Lenses
• Cuvettes
• Water bath
• Optics
Symptoms • Optical read message codes (4000-4999)

• Shift in values
Hardware
The hardware has mechanical components that move consumables and samples through the
system and distribute power and electrical signals:
Examples • Reagent carousel

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Troubleshooting
• Reaction carousel
• Sensors
• RSM bar code reader
Symptoms • Robotics and sensor message codes (5000-5999)

• Bar code read message codes (4000-4999)
• Homing failures, jams, and step losses
Software
The software has computer instructions that interpret the system and assay information,
calculate results, and provide the interface to control the system hardware:
Examples System, assay, maintenance, and diagnostic software

Symptoms • Software message codes (9000-9999)
• Inability to power on the system control module
Consumables
Consumables are supplies that are necessary to run assays:

Examples • Sample cups
• Bulk solutions
• Reagent cartridges
Symptoms Imprecise results or erratic results
System troubleshooting variables (i‑series)

The system category is a high-level group of symptoms that relate to system performance. This
category contains more specific subcategories or variables. Trace an error or a problem to one
of these variables to begin to isolate the probable cause.

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Troubleshooting
Fluidics subsystems
Fluidics subsystems are hardware components that control the precision and accuracy of liquid
level sensing, aspiration, and dispense. In addition, these components distribute the fluids used
to wash the probes:
Examples • Pipettors and probes
• Liquid level sense (LLS) antennae
• Syringes and valves
• Pumps
Symptoms • LLS and fluidics message codes (3000-3999)

• Imprecise results or erratic results
Optical subsystem
The optical subsystem has hardware components that control concise and accurate optical
readings:
Examples • Optics
• Shutter
• Read magnet
Symptoms • Optical read message codes (4000-4999)

• Shift in values
Hardware
The hardware has mechanical components that move consumables and samples through the
system and distribute power and electrical signals:
Examples • Reagent carousel
• Sensors
• RV loader
• RSM bar code reader
Symptoms • Robotics and sensor message codes (5000-5999)

• Bar code read message codes (4000-4999)

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Troubleshooting
• Homing failures, jams, and step losses
Software
The software has computer instructions that interpret the system and assay information,
calculate results, and provide the interface to control the system hardware:
Examples System, assay, maintenance, and diagnostic software

Symptoms • Software message codes (9000-9999)
• Inability to power on the system control module
Consumables
Consumables are supplies that are necessary to run assays:

Examples • Sample cups
• Bulk solutions
• Reaction vessels
Symptoms Imprecise results or erratic results
Reagent troubleshooting variables (c‑series)

The reagent category is a high-level group of symptoms that relate to the processing of results.
This category contains more specific subcategories or variables. Trace an error or a problem to
one of these variables to begin to isolate the probable cause.
Reagent kits
Reagent kits contain consumables that detect and measure the specific analyte presence or
concentration in samples:
Examples • Reagents
• Sample diluents
• Pretreatments
Symptoms • Controls that fall outside the range

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• Trends and shifts in control results or patient results
Calibrators
Calibrators are samples with known concentrations of analytes that are used to create the
calibration against which samples are measured:
Examples Analyte-specific and multiconstituent calibrators
Symptoms Shifts in control results and patient results
Controls
Controls are samples with known concentrations of analytes that are used for performance
monitoring within a clinical range:
Examples Analyte-specific and multiconstituent controls

• Imprecise control results
Reagent troubleshooting variables (i‑series)

The reagent category is a high-level group of symptoms that relate to the processing of results.
This category contains more specific subcategories or variables. Trace an error or a problem to
one of these variables to begin to isolate the probable cause.
Reagent cartridges
Reagent cartridges contain consumables that detect and measure the specific analyte presence
or concentration in samples:
Examples • Antibody-coated microparticles
• Conjugate
• Assay-specific diluent

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Calibrators
Calibrators are samples with known concentrations of analytes that are used to create the
calibration against which samples are measured:
Examples Analyte-specific calibrators
Symptoms Shifts in control results and patient results
Controls
Controls are samples with known concentrations of analytes that are used for performance
monitoring within a clinical range:
Examples Analyte-specific and multiconstituent controls

• Imprecise control results
Operator troubleshooting variables

The operator category is a group of symptoms that relate to correct system operation and
maintenance. Within this category, the actions of one operator or multiple operators can result in
a variety of symptoms:
Examples A new user and a trained operator

Symptoms • Bubbles in reagents or samples
• Particulate matter or fibrin in samples
• General message codes (0001-0999)
• Assay-specific message codes (1000-1999)
• Message codes that are generated because of incorrect
maintenance or incorrect component replacement

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Environmental troubleshooting variables

The environmental category is a high-level group of symptoms that relate to the processing of
results. This category contains more specific subcategories or variables. Trace an error or a
problem to one of these variables to begin to isolate the probable cause.
Physical requirements
Physical requirements identify the environmental conditions that are needed for optimal system
performance:
Examples • Room temperature and humidity
• Location and instrument clearances
• Water quality
Symptoms • Temperature message codes (7000-7999)

• Inadequate airflow
Electrical requirements
Electrical requirements identify the power requirements that are needed for optimal system
performance and optical readings:
Examples Power outlet, voltages, and dedicated line
Symptom Loss of power to the system
Host interface components
Host interface components enable communication between the host interface and the
Alinity ci‑series:
Examples Ports, cables, and connections
Symptoms Communication message codes (8000-8999)

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Section 10 Alert Center flyout
Alert Center flyout

In the Alert Center flyout, the operator can view the following information:
• The last 25 alerts and notifications.
• The probable cause and corrective action for a message.
The operator can clear all messages in the Alert Center flyout.
Alert Center flyout element descriptions, page 1033
View the probable cause and corrective action for a message, page 1034
View additional messages that are associated with a message, page 1034
Delete a message from the Alert Center, page 1035
Clear all messages, page 1035
Alert Center flyout element descriptions

The Alert Center flyout displays alert and notification messages for system problems that require
attention. The Alert Center stores a maximum of 25 messages that are sorted based on newest
to oldest. Messages are displayed in the Alert Center until they are cleared.
Elements
All tab Displays all alert and notification messages generated.
Alerts tab Displays all alert messages generated.
Notifications tab Displays all notification messages generated.
Function buttons

Clear All Displays a message requesting confirmation to clear all

messages in the Alert Center. Individual messages can be
cleared by tapping the X in the upper-right corner of the
message. Cleared messages are retained in system logs.
Show Logs Navigates to the System Logs screen.

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Alert Center flyout Section 10
? Message Displays Help from the operations manual for the selected
message code.

View the probable cause and corrective action for a message

Perform this procedure to view the probable cause and corrective action for a message.
1. On the menu bar, tap Alert Center.
2. In the Alert Center flyout, tap a message to view.
NOTE: To display older messages, slide the horizontal scroll bar to the right side of the
flyout. To filter the list of messages, tap the Alerts tab or the Notifications tab.
3. Tap ? Message.
The probable cause and corrective action in the operations manual is displayed for the
selected message.
View additional messages that are associated with a message

Perform this procedure to view additional messages that are associated with a message that is
displayed in the Alert Center.
2. In the Alert Center flyout, tap a message to view.
3. Tap Show Logs.
On the System Logs screen, the selected message is displayed. If additional messages are
associated with the selected message, a Plus button is displayed at the left side of the
Date/Time column.
4. Tap to display the additional messages.

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Section 10 Alert Center flyout
Delete a message from the Alert Center

Perform this procedure to delete a message from the Alert Center.
2. In the Alert Center flyout, tap a message to delete.
3. To delete the message, tap the Close button in the upper-right corner of the message
box.
Clear all messages

Perform this procedure to delete all messages from the Alert Center.
2. In the Alert Center flyout, tap Clear All.
4. To close the Alert Center flyout, tap the Close button in the upper-right corner.

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System Logs screen Section 10
System Logs screen

On the System Logs screen, the operator can view a record of all system messages that can be
used to troubleshoot problems associated with system performance and results reporting. On the
screen, the messages are filtered by the following categories:
• Alerts and notifications: A record of critical messages, alert messages, and notification
messages
• Informational: A record of informational messages
• Inventory: A record of supply-related messages
• User access: A record of new users that have been created, edits to user data, and logon
and logoff events
• Configuration: A record of changes to configuration
• Interfaces: A record of host interface communication messages, laboratory automation
system messages, and Alinity PRO messages
• Abbott Mail: A record of Abbott Mail activities and status messages
• All messages: A record of all system messages

• Print a log.
• Search for specific log data.
System Logs screen, Notifications/Alerts tab element descriptions, page 1036
System Logs screen, Informational tab element descriptions, page 1038
System Logs screen, Inventory tab element descriptions, page 1039
System Logs screen, User Access tab element descriptions, page 1040
System Logs screen, Configuration tab element descriptions, page 1041
System Logs screen, Interfaces tab element descriptions, page 1042
System Logs screen, Abbott Mail tab element descriptions, page 1043
System Logs screen, All Messages tab element descriptions, page 1044
System Logs screen, Search flyout element descriptions, page 1046
Message Details For flyout element descriptions, page 1049
Descriptions of message types, page 1049
System Logs screen, Notifications/Alerts tab element descriptions

The Notifications/Alerts tab displays alert, critical, and notification message codes.

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Section 10 System Logs screen
Elements
button Displays the Message Details For flyout.
Date/Time Displays the date and time that the message code was
generated.
Module Displays the number of the module that generated the

message code. The module number for messages associated
with the system control module is 6.
Message Displays the message code number and description. In the

first column, a Plus button associated with the message
code indicates that related message codes with additional
details are available.
Message Type Displays the type of message code generated. The

Notifications/Alerts tab has three message types:
• Alert
• Critical
• Notification
Category Displays the related message category. The Notifications/

Alerts tab has seven message categories:
• Abbott Mail
• Alinity PRO
• Configuration
• Host
• Inventory
• LAS
• User Access
Function buttons

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Message Help Displays Help from the operations manual for the selected
message code.
System Logs screen, Informational tab element descriptions

The Informational tab displays informational message codes.
Elements
generated.


Category Displays the related message category. The Informational tab

has seven message categories:
• Abbott Mail
• Alinity PRO
• Configuration
• Host
• Inventory
• LAS
• User Access

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Function buttons
message code.
System Logs screen, Inventory tab element descriptions

The Inventory tab displays message codes related to inventory.
Elements
generated.


Message Type Displays the type of message code generated. The Inventory
tab has four message types:
• Alert
• Critical
• Informational
• Notification

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Supply Name Displays the name of the supply item associated with the
message code.

system when the message code was generated.
Function buttons
message code.
System Logs screen, User Access tab element descriptions

The User Access tab displays message codes related to user access.
Elements
generated.

Message Type Displays the type of message code generated. The User
Access tab has four message types:
• Alert
• Critical

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• Informational
• Notification
Function buttons
message code.
System Logs screen, Configuration tab element descriptions

The Configuration tab displays message codes related to configuration.
Elements
generated.


Message Type Displays the type of message code generated. The

Configuration tab has four message types:
• Alert

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• Critical
• Informational
• Notification

Function buttons
message code.
System Logs screen, Interfaces tab element descriptions

The Interfaces tab displays message codes related to host communications.
Elements
generated.

Message Type Displays the type of message code generated. The Interfaces
tab has four message types:
• Alert

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• Critical
• Informational
• Notification
Category Displays the related message category. The Interfaces tab

has three message categories:
• Alinity PRO
• Host
• LAS
Function buttons
message code.
System Logs screen, Abbott Mail tab element descriptions

The Abbott Mail tab displays message codes related to Abbott Mail.
Elements
generated.


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Message Type Displays the type of message code generated. The Abbott
Mail tab has four message types:
• Alert
• Critical
• Informational
• Notification
Mail Category Displays the type of Abbott Mail item associated with the
message code. The Abbott Mail tab has four mail categories:
• Assay File
• Assay Insert
• System Update
• Calibrator Data

Function buttons
message code.
System Logs screen, All Messages tab element descriptions

The All Messages tab displays all message codes generated by the system. Message codes
can be filtered by message types and message categories by selecting the appropriate tab.

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Elements
generated.


Message Type Displays the type of message code generated. The All
Messages tab has four message types:
• Alert
• Critical
• Informational
• Notification
Category Displays the related message category. The All Messages

tab has seven message categories:
• Abbott Mail
• Alinity PRO
• Configuration
• Host
• Inventory
• LAS
• User Access
Function buttons

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Troubleshooting
message code.
System Logs screen, Search flyout element descriptions

In the Search flyout of the System Logs screen, the operator can enter specific data that is used
to filter the data on the screen. The search criteria differ based on the specific tab of the
System Logs screen. Thus, not all the following criteria (elements) are displayed on all tabs on
the System Logs screen.
Elements
Module Displays a check box for each module in the system. Module
0 indicates the reagent and sample manager messages.
Module 6 indicates the system control module.
Message Code Displays a text box that is used to enter the message code
number.
Message Type Displays a check box for each message type. The following
message type check boxes may be displayed:
• Alert
• Critical
• Informational
• Notification
Supply Name Displays a drop-down list that is used to select a supply

name.
NOTE: This element is displayed only on the Inventory tab.
Mail Category Displays a drop-down list that is used to select a mail

category. The following mail category items may be provided
in the drop-down list:
• Assay File

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Troubleshooting
• Assay Insert
• Calibrator Data
• System Update
NOTE: This element is displayed only on the Abbott Mail tab.

system when the message was generated.
Message Category Displays a check box for each message category. The
following message category check boxes may be displayed:
• Abbott Mail
• Alinity PRO
• Configuration
• Host
• Inventory
• LAS
• User Access
Message Text Displays a text box that is used to enter the message code
text.
Message Class Displays a check box for each message class. The following
message class check boxes may be displayed:
0001-0999 General message codes
1000-1999 Assay-specific message codes
2000-2999 Maintenance and diagnostic message

codes
3000-3999 Level sense and fluidics message

codes
4000-4999 Optics and bar code reader message

codes
5000-5999 Robotics and sensor message codes
6000-6999 Support system message codes

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7000-7999 Temperature message codes
8000-8999 Computer hardware peripheral

message codes
9000-9999 Software message codes

Time From Displays a spin box that is used to enter a search start time.
To Displays a spin box that is used to enter a search end time.

Function buttons




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Message Details For flyout element descriptions

The Message Details For flyout displays additional message codes that provide detailed
information related to the primary message code.
Elements
generated.
Message Type Displays the type of message code generated. The Message
Details For flyout has four message types:
• Alert
• Critical
• Informational
• Notification
Function buttons

Descriptions of message types

Message type information is used to determine the severity of a message code.
The following list provides descriptions of the message types. The message types are described
in the order in which they are sorted:
Alert The message is displayed in the Alert Center flyout and

indicates a condition that affects the system's ability to
generate results.
Critical The message is displayed in a pop-up window and indicates a

critical condition that requires immediate corrective action.

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Informational The message is displayed only in system logs and indicates

an additional message associated with an alert message or
information that is tracked but does not require corrective
action.
Notification The message is displayed in the Alert Center flyout and

indicates a condition that can affect the system's ability to
generate results if the condition is not resolved.
System Logs screen, Search flyout element descriptions, page 1046
Log Report element descriptions, page 1666

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Section 10 Message codes
Message codes
Message codes are divided into 10 sections that reflect the major categories in which errors may
occur. Probable causes and associated corrective actions are provided for each message code.
If the corrective actions for a message code do not resolve the problem, contact the local
NOTE: Corrective actions may involve hazardous activity. Use caution to minimize operator
exposure and to prevent personal injury or system damage. Examples of hazardous activities
include:
• The replacement of system probes.
• The use of reagents, calibrators, controls, and specimens.
• The removal of physical obstructions.
• The removal of system waste.
General message codes (0001-0999), page 1051
Assay-specific message codes (1000-1999), page 1108
Maintenance and diagnostic message codes (2000-2999), page 1173
Level sense and fluidics message codes (3000-3999), page 1199
Optics and bar code reader message codes (4000-4999), page 1259
Robotics and sensor message codes (5000-5999), page 1269
Support system message codes (6000-6999), page 1346
Temperature message codes (7000-7999), page 1346
Computer hardware peripheral message codes (8000-8999), page 1353
Software message codes (9000-9999), page 1378
General message codes (0001-0999)

The general message code category includes message codes from 0001 through 0999.
0106, page 1056
0108, page 1056
0109, page 1056
0110, page 1057
0117, page 1057

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Message codes Section 10
0118, page 1057

0139, page 1057
0145, page 1058
0147, page 1058
0148, page 1058
0149, page 1059
0150, page 1059
0151, page 1059
0153, page 1060
0154, page 1060
0155, page 1060
0156, page 1061
0157, page 1061
0158, page 1061
0161, page 1062
0169, page 1062
0172, page 1062
0173, page 1063
0177, page 1063
0178, page 1063
0197, page 1063
0200, page 1064
0201, page 1064
0202, page 1064
0203, page 1064
0204, page 1065
0206, page 1065
0207, page 1066
0209, page 1066
0210, page 1066
0211, page 1066
0212, page 1067
0213, page 1067
0214, page 1067
0215, page 1067
0217, page 1068
0218, page 1068
0220, page 1068
0221, page 1069

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Troubleshooting
0222, page 1069

0223, page 1069
0224, page 1069
0225, page 1070
0226, page 1070
0228, page 1070
0229, page 1071
0230, page 1071
0231, page 1071
0232, page 1071
0233, page 1072
0234, page 1072
0235, page 1072
0236, page 1072
0237, page 1073
0238, page 1073
0248, page 1073
0250, page 1074
0251, page 1074
0252, page 1074
0253, page 1074
0254, page 1075
0255, page 1075
0256, page 1075
0257, page 1075
0258, page 1076
0259, page 1076
0260, page 1076
0261, page 1077
0262, page 1077
0263, page 1077
0264, page 1077
0265, page 1078
0266, page 1078
0267, page 1078
0268, page 1079
0269, page 1079
0270, page 1079
0271, page 1080

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0272, page 1080

0273, page 1081
0274, page 1081
0300, page 1081
0301, page 1082
0302, page 1082
0303, page 1082
0304, page 1083
0305, page 1083
0306, page 1083
0307, page 1084
0308, page 1084
0309, page 1084
0310, page 1084
0321, page 1085
0328, page 1086
0331, page 1086
0335, page 1086
0336, page 1086
0337, page 1087
0338, page 1087
0339, page 1088
0340, page 1088
0341, page 1088
0342, page 1089
0343, page 1089
0344, page 1089
0348, page 1090
0357, page 1090
0358, page 1090
0600, page 1090
0601, page 1091
0602, page 1091
0603, page 1091
0604, page 1091
0605, page 1092
0606, page 1092
0607, page 1092
0608, page 1092

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0622, page 1093

0623, page 1093
0626, page 1093
0627, page 1093
0628, page 1094
0656, page 1094
0657, page 1094
0658, page 1094
0659, page 1095
0660, page 1095
0661, page 1095
0662, page 1095
0663, page 1096
0664, page 1096
0665, page 1096
0666, page 1097
0667, page 1097
0679, page 1097
0680, page 1097
0681, page 1098
0682, page 1098
0683, page 1099
0684, page 1099
0685, page 1099
0686, page 1099
0689, page 1099
0690, page 1100
0691, page 1100
0692, page 1100
0693, page 1101
0694, page 1101
0695, page 1101
0696, page 1102
0697, page 1102
0698, page 1102
0699, page 1102
0700, page 1103
0701, page 1103
0702, page 1103

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0703, page 1103

0704, page 1104
0705, page 1104
0706, page 1104
0707, page 1104
0708, page 1104
0709, page 1105
0710, page 1105
0711, page 1105
0712, page 1106
0713, page 1106
0714, page 1106
0749, page 1107
0750, page 1107
0758, page 1107
0759, page 1107
0760, page 1108
Message code: 0106

Authentication failed. Operator ID (0) inactive.
0 = Operator ID
Probable cause Corrective action
An inactive operator ID was entered. Status message. No corrective action is required.
Message code: 0108

Authentication failed. Operator ID (0) invalid.
0 = Operator ID
An invalid operator ID was entered. Enter the correct operator ID.
Message code: 0109

An unexpected error (0) occurred while exporting user data.
0 = Error description

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User export failed because of an unexpected error. A Review the specific message text. Perform the
specific error description is provided where available. corrective action for the specific message text.
Message code: 0110

An unexpected error (0) occurred while importing user data.
0 = Error
The data file is damaged or corrupted. Repeat the data import procedure with a new file.
Software error. Contact Customer Service. Provide information about
the operation that was attempted when the error
occurred.
Message code: 0117

Unable to retrieve log. Invalid log file type (0) or invalid log name (1).
0 = File type
1 = Log name
The requested log file cannot be retrieved by Abbottlink. Contact Customer Service. Provide information about
occurred.
Message code: 0118

Authentication failed. (0) for operator ID (1) invalid.
0 = PIN or password
1 = Operator ID
The authentication failed. The supplied credential was Status message. No corrective action is required.
invalid.
Message code: 0139

Unable to perform automatic system backup. Instrument is not in the correct status.

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Troubleshooting

The instrument was not in the correct status for the Perform a manual backup, page 382 or wait until the
automatic backup to be performed. next scheduled automatic backup.
Message code: 0145

Unable to perform requested operation. Cuvette segment alignment tool detected in cuvette (0).
0 = Cuvette
The cuvette segment alignment tool was not removed 1. Remove the cuvette segment alignment tool from
from the reaction carousel after a pipettor calibration the reaction carousel.
procedure was performed.
2. Place the cuvette segment into the position.
Water is present on the slotted edges of a cuvette Dry the slotted edge of the cuvette segment.
segment.
The cuvette tab is broken. Replace the cuvette segments (c‑series), page 941.
Hardware failure. Contact Customer Service to resolve any hardware
failure.
Message code: 0147

Unable to perform requested operation. Remove racks from sample positioners on module (0).
0 = Module
The initialization of the reagent and sample manager Remove racks from the sample positioners, page 1464.
(RSM) failed.
A physical interference is blocking the movement of the Locate and remove any physical obstruction.
RSM.
The module was unable to pick racks at the sample Perform Sample Manager diagnostic procedure 1600
positioners. RSM Transport Calibration, page 917.
failure.
Message code: 0148

Run initialization failed.

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Hardware failure. Additional messages that are associated with this
message can be used to determine the appropriate
corrective action. View additional messages that are
associated with a message, page 1034.
Message code: 0149

Unable to process test. Reagent cartridge unavailable.
A reagent cartridge that was selected to be unloaded 1. Load the required reagent cartridge. Perform Load
had scheduled tests in process. cartridges on the reagent and sample manager
(RSM), page 599.
2. Rerun the test. Perform Rerun a test or an
exception for a specimen or control, page 703.
Message code: 0150

Unable to process test. Previous processing module error.
A processing module error occurred. 1. Review the message log for messages that
occurred at the same time as this message.
Perform the corrective action.
Message code: 0151

Duplicate rack detected on module (0) position (1).
0 = Module
1 = Position
A rack with a duplicate rack ID is already loaded on the • Remove the second rack with the duplicate rack ID.
system. After the first rack on the instrument with the
duplicate rack ID is completed processing and is
unloaded, the second rack can be reloaded.

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Troubleshooting

• Load the samples from the rack with the duplicate
rack ID into a rack with a different rack ID, and
then load the rack on the reagent and sample
manager.
Message code: 0153

Unable to process test. ICT Reference Solution empty.
The ICT Reference Solution bottle is empty. Load a new bottle and update the inventory. Perform
Replace bulk solutions and update the inventory, page
579.
The Supplies screen was not updated when the ICT Update the inventory. Perform Replace bulk solutions
Reference Solution bottle was replaced. and update the inventory, page 579.
failure.
Message code: 0154

Unable to process test. Rack removed from RSM before access granted.
The rack was removed from the reagent and sample 1. Rerun the test. Perform Rerun a test or an
manager (RSM). exception for a specimen or control, page 703.
2. Reload the rack into the RSM.
Message code: 0155

Unable to load reagent cartridge in RSM position (0). No assay installed.
0 = RSM position
The assay file is not installed on the system. Install the assay. Perform Install assay files, page 325.
NOTE: Assay files are available at
abbottdiagnostics.com or can be requested through
Abbott Mail.

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Message code: 0156

Unable to load reagent cartridge in RSM position (0). All reagent carousel positions are full.
0 = RSM position
The reagent carousel is full. 1. Unload a reagent cartridge before new reagent
cartridges are loaded. Perform Unload racks and
cartridges from a reagent carousel to the RSM,
page 631.
2. Load a new reagent cartridge. Perform Load
cartridges on the reagent and sample manager
(RSM), page 599.

failure.
Message code: 0157

Unable to load reagent cartridge in RSM position (0). Reagent cartridge empty.
0 = RSM position
No tests or volume remain for the indicated reagent Load a new reagent cartridge or load a reagent
cartridge. cartridge that has tests or volume remaining. Perform
Load cartridges on the reagent and sample manager
(RSM), page 599.
Message code: 0158

Unable to perform requested operation. Remove rack from reagent positioner.
A rack was found on the reagent positioner. 1. Remove the rack from the reagent positioner.
2. Reinitialize the reagent and sample manager.
Perform Start the processing module and the
reagent and sample manager (RSM), page 500.

failure.

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Message code: 0161

Unable to process test. Water bath level low or temperature out of range.
A water bath level or temperature error occurred while 1. Additional messages that are associated with this
the test was being processed. message can be used to determine the appropriate
Message code: 0169

Reagent access cover removed.
The reagent access cover was removed. Replace the reagent access cover.
Reagent access cover sensor failure. Contact Customer Service to resolve any hardware
failure.
Message code: 0172

Unable to process test. Processing module not in Running status.
The operator stopped the processing module before Reinitialize the processing module. Perform Start the
processing began. processing module and the reagent and sample manager
(RSM), page 500.
Hardware failure. 1. Review the message log for messages that

80000071-105 - 2018-09-10
Troubleshooting
Message code: 0173

Unable to process test. Reagent sample manager not in Running status.
The operator stopped the reagent and sample manager Reinitialize the RSM. Perform Start the processing
(RSM) before processing began. module and the reagent and sample manager (RSM),
page 500.
Message code: 0177

Unable to perform automatic system backup. Automatic backup disabled.
The automatic backup is disabled. Enable the automatic backup. Perform Configure an
automatic backup, page 240.
Message code: 0178

Invalid order for SID (0). Rack/position (1/2) already contains order for SID (3).
0 = SID
1 = Rack ID
2 = Position
3 = SID
An order exists for the indicated rack and position. Create an order that uses a different rack and position.
Message code: 0197

FSE logon required to complete initial system configuration settings.
An FSE logon is required to change the module Contact Customer Service.
configuration.

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Troubleshooting
Message code: 0200

Unable to process test. Rack transport error.
An error occurred with the RSM transport when a rack Rerun the test. Perform Rerun a test or an exception for
was transported. a specimen or control, page 703.
The rack is damaged. Replace the damaged rack.
The RSM transport is out of alignment. Perform Sample Manager diagnostic procedure 1600
RSM Transport Calibration, page 917.
failure.
Message code: 0201

Run request denied. Module is not in the correct status.
An attempt was made to run the module when the Repeat the request to run the module when the system
system was in an incorrect instrument status. is in a status of Stopped, Idle, or Pausing.
Message code: 0202

Unable to process test. Process path disabled.
An error occurred on the process path or pretreatment 1. Review the message log for messages that
path. occurred at the same time as this message.
Message code: 0203

Processing module initialization failed. The unload access sensor is not detected.

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Troubleshooting

The RV unloader was not detected during initialization. The RV unloader is not installed. See Process path
(Alinity i), page 107 to locate the RV unloader.
The RV unloader is not seated correctly. Verify that the RV unloader is in the correct position.
See Process path (Alinity i), page 107 to locate the RV
unloader.
For the two-piece process path light cover, the RV Replace the RV unloader access piece of the process
unloader access piece of the process path light cover is path light cover. Perform Remove and replace the two-
missing. piece process path light cover (i‑series), page 995.
For the two-piece process path light cover, the RV Verify that the RV unloader access piece of the process
unloader access piece of the process path light cover is path light cover is in the correct position. Perform
not seated correctly. Remove and replace the two-piece process path light
cover (i‑series), page 995.
failure.
Message code: 0204

The reagent access cover was removed. Status message. Reagents in the reagent carousel are
removed, scanned, and replaced.
Message code: 0206

Unable to execute command. Operator requested Stop or hardware error.
The operator transitioned the instrument to the Stopped 1. Resolve the reason the instrument was transitioned
status. to the Stopped status.
2. Start the processing module and the reagent and
sample manager (RSM), page 500.
Communication error. Review the message log for messages that occurred at
the same time as this message. Perform the corrective
action.
failure.

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Troubleshooting
Message code: 0207

Start initialization failed.
Message code: 0209

Start or Run initialization failed.
Message code: 0210

Module transitioning to Pausing status. (0) failed.
0 = Mechanism
Hardware failure. • Review the specific message text. Perform the
corrective action for the specific message text.
• Contact Customer Service to resolve any hardware
failure.
Message code: 0211

Rack detected at module (1) position (0). Remove rack. This position is not available.
0 = Position
1 = Module
A rack was loaded in a position that is already in use. Remove the rack that was loaded in a position that is
already in use.

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Troubleshooting
Message code: 0212

Rack ID (0) removed from module (2) position (1) before access granted.
0 = Rack ID
1 = Position
2 = Module
The rack was removed before access was granted. Tests with a scheduled status become exceptions.
Reorder the tests.
Message code: 0213

Unable to load reagent cartridge in RSM position (0). Reagent cartridge is for the (1) processing module.
0 = RSM position
1 = Module
No processing module is available for the reagent type. Load a new reagent cartridge for the correct module
type.
Message code: 0214

Unable to process test. Sample diluent insufficient or not available.
The required sample diluent is empty or expired. Load a new onboard solution cartridge. Perform Load
onboard solutions and sample diluents on the reagent
and sample manager (RSM) (c‑series), page 604.
Message code: 0215

Unable to process test. Reagent cartridge for assay number (0) version (1) has insufficient volume or is
unusable.
0 = Assay number
1 = Assay version

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The indicated reagent cartridge is empty or expired. Load a new reagent cartridge. Perform Load cartridges
on the reagent and sample manager (RSM), page 599.
The calibration has exceeded the expiration date for the Calibrate the reagent lot again.
assay.
Message code: 0217

Unable to create order for sample in rack ID (0). Position ordered (2) does not match position scanned
(1).
0 = Rack ID
1 = Position scanned
2 = Position ordered
The control sample was found in a different position in Verify that the control sample is in the correct position in
the rack. the rack.
Message code: 0218

Unable to process test. Module (0) not available.
0 = Module
The processing module transitioned to a status of Start the processing module and the reagent and sample
Offline or Stopped when tests were in process. manager (RSM), page 500.
Message code: 0220

No pending orders found for SID (0) in rack ID (1) position (2).
0 = SID
1 = Rack ID
2 = Position
No orders were found for a bar-coded sample. Create an order for the bar-coded sample.

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Troubleshooting
Message code: 0221

Priority order for SID (0) in rack ID (1) position (2) loaded in RSM routine position. SID will not be
processed as priority sample.
0 = SID
1 = Rack ID
2 = Position
Samples that are designated as STAT must be priority Load STAT samples in a priority position of the reagent
loaded to be processed as STAT samples. and sample manager.
Message code: 0222

Module initialization failed after fault condition detected.
The initialization failed. Cycle power to the processing module and the reagent
and sample manager (RSM), page 484.
failure.
Message code: 0223

Unable to process test. Instrument status is not Running or Processing.
The processing module is no longer in the Running To transition the instrument status of the processing
status or the Processing status. module to Running, perform Initiate or resume sample
processing, page 648 for the appropriate module.
Message code: 0224

Run request denied. RV waste container not present.
The RV waste container is not present in a processing Replace the RV waste container.
module.

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Troubleshooting
Message code: 0225

Unable to process test. Hardware error or operator requested Stop.
The operator transitioned the instrument status to 1. Resolve the reason that the instrument status was
Stopped. transitioned to Stopped.
3. Rerun a test or an exception for a specimen or
control, page 703.

2. Rerun a test or an exception for a specimen or
control, page 703.
Message code: 0226

The reagent access cover is missing. 1. Replace the reagent access cover.
The reagent access cover sensor failed. Contact Customer Service to resolve any hardware
failure.
Message code: 0228

Rack or cartridge detected on module (0) RSM position (1) without a tray.
0 = Module
1 = RSM position
A rack or cartridge was detected on the loading area Remove the rack or cartridge from the loading area.
without a tray. Place the rack or cartridge in a tray, and then load the
tray on the reagent and sample manager of the
processing module.

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Troubleshooting
Message code: 0229

Tray on module (0) bay (1) removed before access was granted.
0 = Module
1 = RSM bay
The tray was removed from the loading area of the Load the tray into the bay indicated on the processing
processing module before access was granted. module. Do not remove trays before access is granted.
Message code: 0230

Unable to process test. Control lot expired.
The control is expired. Load a new control.
Message code: 0231

Number of unreleased results reached limit. New orders will not be accepted.
The limit of the number of unreleased results has been Delete or release results, controls, or exceptions before
reached. new orders are created. Perform Delete a sample result
or an exception, page 727 and Transmit a result or an
exception to the host, page 727.
Message code: 0232

Unable to process test. Sample removed from system.
The rack or tray was removed from the reagent and 1. Load the rack on the RSM. Perform Load racks on
sample manager (RSM) before the access indicator was the reagent and sample manager (RSM), page 595.
activated.
2. Rerun the exception. Perform Rerun a test or an

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Troubleshooting
Message code: 0233

Unable to process test. Reagent onboard solution cartridge empty.
The R1 onboard solution cartridge is empty. Load a new onboard solution cartridge. Perform Prepare
onboard solutions (c‑series), page 625 or Load onboard
solutions and sample diluents on the reagent and sample
manager (RSM) (c‑series), page 604.
Message code: 0234

Unable to process test. Reagent onboard solution cartridge empty.
The R2 onboard solution cartridge is empty. Load a new onboard solution cartridge. Perform Prepare
onboard solutions (c‑series), page 625 or Load onboard
solutions and sample diluents on the reagent and sample
manager (RSM) (c‑series), page 604.
Message code: 0235

RSM load error for a two-cartridge reagent set. Unload reagent cartridges in RSM positions (0) and (1).
0 = RSM position
1 = RSM position
A two-cartridge reagent set did not load successfully. Unload and reload the reagent cartridges from the
reagent and sample manager. Perform Load cartridges
A reagent cartridge is damaged. Load a new reagent cartridge. Perform Load cartridges
failure.
Message code: 0236

Number of unreleased results reached 90% of the allowable limit.

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The number of unreleased results reached 90% Release or delete unreleased specimen results, control
capacity. results, or exceptions on the system. Perform Delete a
sample result or an exception, page 727.
Message code: 0237

Unable to process test. Reagent cartridge unavailable.
A reagent cartridge was scheduled to be unloaded when 1. Prepare reagent cartridges, page 622.
tests were in process.
2. Load a new reagent cartridge for the assay.
Perform Load cartridges on the reagent and sample
manager (RSM), page 599.
3. Rerun the exception. Perform Rerun a test or an
Message code: 0238

Unable to perform requested operation. Remove rack from reagent positioner.
A rack was found on the reagent positioner. Remove the rack from the reagent positioner. Perform
Start the processing module and the reagent and sample
failure.
Message code: 0248

Unable to add order. SID (0) exists with different sample type.
0 = SID
An order exists for the SID that uses a different sample Create a new order that uses the correct sample type.
type (calibrator, control, or specimen). Perform Create a single specimen order, page 682.

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Troubleshooting
Message code: 0250

Unable to update order for SID (1). Manual dilution factor (0) is different than manual dilution factor for
pending order.
0 = Manual dilution
1 = SID
The manual dilution that was entered for the current Enter the same manual dilution that was entered for the
order is different from the manual dilution that was pending order. Perform Create a single specimen order,
entered for the pending order. page 682.
Message code: 0251

Invalid order. Calibration order already exists for SID (0) in rack ID/position (1/2).
0 = SID
1 = Rack ID
2 = Position
A calibration order already exists for the rack ID and Create the calibration order using a different rack ID and
position. position. Perform Create a calibration order, page 688.
Message code: 0252

Invalid order. SID (0) exists for previously ordered sample.
0 = SID
An attempt was made to create a new order for an SID Create the new order for the SID with a different rack ID
without a rack ID and position. An order already exists and position. Perform Create a single specimen order,
for the SID. page 682.
The system received an order from the host for an SID 1. Wait until the batch order is completed.
that is the starting SID for an existing batch order. The
2. Load the sample rack with the SID for the host
host order is ignored by the system.
order.
Message code: 0253

Unable to create order. HIL replicate or calculated assay (0) already exists for sample.
0 = HIL or calculated assay

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Troubleshooting

An attempt was made to order a replicate for HIL or a Complete the test for the existing order before the
calculated assay when an order already exists. replicate is ordered.
Message code: 0254

Duplicate rack ID (0) detected.
0 = Rack ID
The rack ID is already loaded on the reagent and Load the samples in a rack with a different rack ID and
sample manager (RSM). load the rack on the RSM.
Message code: 0255

Sample with pending priority order loaded in rack ID (0) position (1).
0 = Rack ID
1 = Position
Samples that are designated as STAT must be priority Load STAT samples in a priority position of the reagent
loaded to be processed as STAT samples. and sample manager.
Message code: 0256

A tray has been removed from the RSM on module (0) that is needed to place the rack back in RSM
position (1).
0 = Module
1 = RSM position
A tray with racks in process has been removed from the Load trays on the reagent and sample manager (RSM),
reagent and sample manager (RSM). page 594.
Message code: 0257

(0) cover opened when module status is Running or Processing.
0 = Processing center cover

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Troubleshooting

A processing center cover was opened. 1. Close the processing center cover.
2. Perform Start the processing module and the

failure.
Message code: 0258

RSM stopped. Front processing center cover opened.
A front processing center cover was opened while the 1. Close the processing center cover.
reagent and sample manager was in a Running status.

failure.
Message code: 0259

Unable to delete all selected results. Result is either a constituent of a calculated assay or pending
transmission to the host.
An attempt was made to delete an assay that is a • Delete or edit the calculated assay before the
constituent assay for a calculated assay. constituent assay is deleted.
• Wait until the results have been transmitted to the
host before the results are deleted.
Message code: 0260

Unable to process test. Calculated result exceeds limits.
A calculated result cannot be computed. The result Modify the calculated result formula or the constituent
exceeds the numerical limit of the software. assay ranges. Perform Create a calculated assay, page
302.

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Troubleshooting
Message code: 0261

Tray in bay (1) on module (0) has been unexpectedly removed.
0 = Module
1 = Bay
A tray with racks in process was removed from the 1. Restart the RSM. Perform Start the processing
reagent and sample manager (RSM) before the access module and the reagent and sample manager
indicator was activated. (RSM), page 500.
2. Load trays on the reagent and sample manager
(RSM), page 594.
A tray is defective. Replace the tray.
Message code: 0262

A retest rule with the same name is already defined.
The name of the retest rule already exists. Use a different name for the retest rule.
Message code: 0263

Operator ID (0) changed one or more module configuration parameters for module (1).
0 = Operator ID
1 = Module
A change was made to the module configuration. Status message. No corrective action is required.
Message code: 0264

Unable to create retest order. Assay not longer available on system.
An assay that is required for a retest is not loaded on Install the assay. Perform Install assay files, page 325.
the system.

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Troubleshooting

Abbott Mail.
Message code: 0265

Unable to add order. Insufficient positions in rack ID (0) for all calibrators.
0 = Rack ID
The number of positions required for the calibration Create the calibration order using a rack with the
exceeds the number of available positions in the rack. required number of available positions. Perform Create a
calibration order, page 688.
Message code: 0266

Run request denied. Reagent cartridges or racks are currently being loaded or unloaded from the
reagent carousel.
Reagent cartridges or racks are in the process of Wait for the unload or load process to be completed
unloading from the reagent carousel or loading to the before requesting a Run initialization.
reagent carousel.
Message code: 0267

Unable to create order. Invalid rack ID (0).
0 = Rack ID
An invalid rack was used for the sample type. • To load aliquot tubes, primary tubes, or sample
cups that contain samples (specimens, calibrators,
or controls) into sample racks, perform Load
samples into sample racks, page 643.
• To load calibrator and control vials into vial racks,
perform Prepare and load calibrator and control
vials into vial racks for immediate use, page 646.

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Troubleshooting
Message code: 0268

Vial with bar code (0) is already loaded onboard.
0 = Vial bar code
A vial with same bar code is already loaded on the Contact Customer Service to report the duplicate vial
system. bar code.
Message code: 0269

The vial rack is on the RSM at location (0). Remove the vial rack and store in refrigerated storage.
0 = RSM location
The vial rack processing is completed. Remove the vial rack and place the vials into
refrigerated storage. Perform Unload vials from the
Message code: 0270

Unable to process test. No processing module available.
The processing module is not in the Running status or Initiate or resume sample processing, page 648.
Processing status.
One or more onboard solutions are empty, expired, or 1. Prepare onboard solutions (c‑series), page 625.
not available on all processing modules that have an
2. Load cartridges on the reagent and sample
instrument status of Running.
One or more reagent kits for the assay are empty, Load a new reagent cartridge. Perform Load cartridges
expired, or not available on all processing modules that on the reagent and sample manager (RSM), page 599.
have an instrument status of Running.
Processing modules in the Running status do not have Load the required inventory items on the system and
sufficient supplies to process the tests. update the inventory. Perform Verify the supply and
waste inventory, page 579.
A previous hardware failure prevented the Run 1. Review the message log for the messages that
initialization. The processing module transitioned to the occurred at the same time as this message.
Stopped status. Perform the corrective action.

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Troubleshooting

2. Reinitialize the processing module. Perform Start
the processing module and the reagent and sample
The requested assay is not installed on the system. Install the assay. Perform Install assay files, page 325.
Abbott Mail.
Message code: 0271

Unknown calibrator or control bar code (0) found in rack ID (1) position (2). Onboard vial rack cannot be
loaded into reagent carousel.
0 = Control bar code
1 = Rack ID
2 = Position
The bar-coded vial is not positioned correctly in the vial Reposition vial in the vial rack.
rack.
The bar code is damaged. 1. Load a different calibrator or control vial.
2. Contact Customer Service. Provide information
about the operation that was attempted when the
error occurred.
The calibrator or control was configured incorrectly or Verify that the calibrators or controls are configured on
has not been configured. the system. Perform Create a new calibrator master lot
(c‑series), page 311 or Create a new calibrator master
lot (i‑series), page 313.
Message code: 0272

Unable to process test. Assay is not enabled.
The requested assay is disabled. 1. Enable the assay. Perform Edit general settings of
assay parameters (c‑series photometric), page 286,
Edit general settings of assay parameters (c‑series
potentiometric), page 289, or Edit general settings
of assay parameters (i‑series), page 290.
2. Rerun the test.

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Troubleshooting
Message code: 0273

Power interrupted to RSM when the module was running. Discard samples in the rack if the rack is
located on the RSM transport.
The main power to the reagent and sample manager 1. Discard the samples in the rack if the rack is
was interrupted while the module had a status of located on RSM transport.
Scheduled or Running.
2. Cycle power to the processing module and the
reagent and sample manager (RSM), page 484

failure.
Message code: 0274

Improper shutdown on user interface computer due to power interruption. Discard samples in rack if rack
is located on RSM transport.
The main power source to the user interface computer 1. If the RSM transport was holding a rack at the time
was interrupted, which caused an improper shutdown. of the power loss, all samples on the rack should
be discarded.
2. Cycle power to the system, page 480

failure.
Message code: 0300

Procedure key is ON. Instrument status transitioned to Idle or Stopped.
The SCM procedure key or the processing module Perform Use a procedure key to perform a procedure,
procedure key was turned to the On setting when a run page 846 to turn the procedure key to the Off setting.
request was attempted while the system control module Repeat the run request.
(SCM) or the processing module was in an instrument
status of Idle.
procedure key was turned to the On setting when a run page 846 to turn the procedure key to the Off setting.
Repeat the run request.

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Troubleshooting

request was attempted while the SCM or the processing
module was in an instrument status of Stopped.
The processing module procedure key was turned to the 1. Perform Use a procedure key to perform a
On setting when the processing module was in an procedure, page 846 to turn the procedure key to
instrument status of Running, Processing, or Pausing. the Off setting.
Message code: 0301

Unable to perform requested operation. Procedure key on.
procedure key is turned to the On setting. page 846 to turn the SCM procedure key or the
processing module procedure key to the Off setting
before a run is requested.
failure.
Message code: 0302

Front or rear processing cover opened when module status is initializing.
A processing center cover was opened. 1. Close the processing center cover.

failure.
Message code: 0303

Unable to process test. Calibrator found during a batch run.
A calibration order was found when a batch run was in • Complete the batch run and reorder the calibration.
process.

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Troubleshooting

• If the calibration is required immediately, terminate
the batch run in process and order the calibration.
Message code: 0304

Batch (0) terminated. Batch (1) started.
0=Batch name
1=Batch name
A batch order was in process when a rack was loaded Create another batch order to complete the processing
that contained a starting SID for a different batch. Batch for the remaining samples. Perform Create a bar-coded
tests in process continue and the remaining tests from batch specimen order, page 684.
this batch are deleted. The new batch order begins.
NOTE: To avoid future occurrences, do not start another
batch order until the batch order in process is
completed.
Message code: 0305

Batch (0) deleted. Batch was in process when the user interface computer was shutdown.
0 = Batch name
The batch was in process when the user interface 1. Cycle power to the system, page 480.
computer unexpectedly shut down. All tests with a status
2. Rerun the test exceptions. Perform Rerun a test or
of Scheduled or Running are sent to exception.
an exception for a specimen or control, page 703.
3. Order another batch for the remaining samples.
Perform Create a bar-coded batch specimen order,
page 684.
Message code: 0306

Non-bar-coded sample in rack ID (0) position (1) detected in bar-coded batch (2).
0 = Rack ID
1 = Position
2 = Batch name

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Troubleshooting

A non-bar-coded sample was detected in a batch that is Status message. No corrective action is required.
in process. The non-bar-coded sample is not processed as part of
the batch.
Message code: 0307

Invalid order. SID (0) exists for a different order.
0 = SID
The specified SID already exists for a specimen, Assign a different SID for the order to be created.
calibrator, control, or batch order.
Message code: 0308

Unable to process test. Sample suspend requested.
The sample was suspended. The tests were sent to Rerun the sample. Perform Rerun a test or an exception
exception and were not processed. for a specimen or control, page 703.
Message code: 0309

Unable to process test. Rack transport error.
An error occurred with the RSM transport when a rack Rerun the test. Perform Rerun a test or an exception for
failure.
Message code: 0310

Unable to process test. Rack removed before access was granted.

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Troubleshooting

The rack was removed from the reagent and sample 1. Rerun the test. Perform Rerun a test or an
manager (RSM) after the test was scheduled but before exception for a specimen or control, page 703.
aspiration could occur.
2. Reload the rack into the RSM.
Message code: 0321

Run or Start request denied. (0).
0 = Initialization error
The available bulk solution inventory is insufficient. Load the required inventory items on the system and
update the inventory. Perform Verify the supply and
The required onboard solutions are not loaded on the Prepare and load a new onboard solution cartridge.
system. Perform Prepare onboard solutions (c‑series), page 625
and Load cartridges on the reagent and sample manager
(RSM), page 599.
The liquid waste container is full. Empty and replace the liquid waste container. Perform
Verify the supply and waste inventory, page 579.
A processing center cover is open. 1. Close the processing center cover.
A previous hardware failure prevented the Run 1. Review the message log for the messages that
initialization. The processing module transitioned to the occurred at the same time as this message.
Stopped status. Perform the corrective action.
The water in the water bath is not circulating because Change the water bath. Perform Reaction Mechanisms
the system was idle for an extended period of time. diagnostic procedure 5005 Exchange Water in Bath
The water bath is filling after the system was idle for an Verify that the temperature returns to specifications.
extended period of time. Perform Temperature diagnostic procedure 4301
Temperature Status (c‑series), page 885.
The room temperature is outside specifications. Modify the room temperature to be within specifications.
failure.

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Troubleshooting
Message code: 0328

Unable to transition to Running. One or more maintenance procedures are overdue.
The operator attempted to transition the system to a Perform the overdue maintenance procedure.
status of Running when maintenance is overdue.
Message code: 0331

Unable to print report automatically. Default printer is not verified. Automatic report printing to the default
printer changed to Off.
The default printer has not been verified. Verify a printer, page 197.
Reports have not been configured for automatic report To verify or enable the default printer for automatic
generation for the default printer. report generation, perform Configure report settings,
page 213.
Message code: 0335

One or more vials (0) in onboard vial rack (1) have been used previously on another rack and are not
allowed to be loaded in the reagent carousel.
0 = Vial bar code
1 = Rack bar code
One or more scanned calibrator or control vials were Load new calibrator or control vials if the vials are
previously scanned for another vial rack. requested to be stored in the reagent carousel. Perform
Prepare and load calibrator and control vials into vial
racks for onboard storage, page 624 and Load racks on
the reagent and sample manager (RSM), page 595.
Message code: 0336

One or more vials (0) in onboard vial rack (1) have a status which is not allowed to be loaded in the
reagent carousel.
0 = Vial bar code
1 = Rack bar code

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Troubleshooting

One or more scanned calibrator or control vials have a Load new calibrator or control vials if the vials are
status of Expired, Low Alert, or Empty, which does not requested to be stored in the reagent carousel. Perform
allow the onboard vial rack to be loaded in the reagent Prepare and load calibrator and control vials into vial
carousel. racks for onboard storage, page 624 and Load racks on
Message code: 0337

The module or modules are not in the correct status or do not presently have space for onboard vial
rack (0) to be loaded in the reagent carousel.
0 = Rack bar code
The instrument status of one or more processing Verify that the instrument status of one or more
modules is Stopped or Offline. processing modules is Idle, Running, or Processing so
that an onboard vial rack can be loaded.
No reagent carousel positions are available on one or Verify that an empty reagent carousel position is
more processing modules and an onboard vial rack available to load the onboard vial rack. Perform Unload
cannot be loaded. racks and cartridges from a reagent carousel to the
RSM, page 631.
Message code: 0338

One or more vials (0) in onboard vial rack (1) have insufficient remaining stability or hours before lot
expiration and are not allowed to be loaded in the reagent carousel.
0 = Vial bar code
1 = Rack bar code
One or more calibrator or control vials in an onboard vial Load new calibrator or control vials if the vials are
rack to be loaded in the reagent carousel have less than requested to be stored in the reagent carousel. Perform
48 hours before the lot expiration and onboard stability Prepare and load calibrator and control vials into vial
expiration are exceeded. racks for onboard storage, page 624 and Load racks on
Vials that are ineligible for onboard storage can be
processed in a vial rack or can be pipetted into sample
cups and processed in a sample rack.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 0339

One or more vial lots (0) in onboard vial rack (1) is not the default lot and is not allowed to be loaded in
0 = Vial bar code
1 = Rack bar code
The bar code of one or more vials does not match the Configure the default lot number to match the bar code
default lot number of the configured calibrator or of the vials loaded in the onboard vial rack. Perform Edit
control. calibrator data (c‑series), page 317, Edit calibrator data
(i‑series), page 319, or Edit a quality control, page 353.
Message code: 0340

One or more vial lots (0) in onboard vial rack (1) is not configured for onboard storage and are not
allowed to be loaded in the reagent carousel.
0 = Vial bar code
1 = Rack bar code
One or more vials in an onboard vial rack were not 1. Verify that all the control vial lot levels for the
configured to be stored in the reagent carousel. onboard vial rack are configured for onboard
storage.
2. Verify that the calibrator vial lot is configured for
onboard storage.
Message code: 0341

One or more vials (0) in onboard vial rack (1) are incomplete and are not allowed to be loaded in the
reagent carousel.
0 = Vial bar code
1 = Rack bar code
One or more vials that are needed for a complete Load all required calibrator vials in the onboard vial
calibrator set are not loaded in an onboard vial rack. rack.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 0342

Vials (0) in onboard vial rack (1) are not in adjacent positions and are not allowed to be loaded in the
reagent carousel.
0 = Vial bar code
1 = Rack bar code
Calibrator vials are not loaded in adjacent positions in Load the calibrator vials in adjacent positions in the
an onboard vial rack. onboard vial rack.
Message code: 0343

Vial rack (0) is not an onboard vial rack and is not allowed to be loaded in the reagent carousel.
0 = Rack bar code
Calibrator or control vials were not loaded in an onboard 1. Load the calibrator or control vials in an onboard
vial rack. vial rack, which is bar-coded for identification with
the letter U.
2. Verify that a position in the reagent carousel is
configured for the onboard storage of the onboard
vial rack and is available to receive the rack.
Message code: 0344

Vial (0) in onboard vial rack (1) has an ineligible status (2) for automatically ordering tests.
0 = Vial bar code
1 = Rack bar code
2 = Vial status
The RSM bar code reader scanned a calibrator or 1. Load a new vial of calibrator or control material in
control vial in an onboard vial rack that has a vial status the onboard vial rack. Perform Prepare and load
of Empty or Expired. calibrator and control vials into vial racks for
onboard storage, page 624.
2. Load the onboard vial rack on the reagent and
sample manager. Perform Load racks on the

80000071-105 - 2018-09-10
Troubleshooting
Message code: 0348

Unable to process test. The sample has more than 220 tests ordered.
More than 220 tests were ordered for a sample on a Reorder the sample with more than 220 tests.
processing module.
Message code: 0357

The blank calibrator set (0) in onboard vial rack (1) is not eligible for onboard storage.
0 = Lot number
1 = Rack bar code
One or more scanned calibrator vials in the onboard vial Remove the vials from the onboard vial rack that are
rack are not allowed to be loaded in the reagent ineligible for onboard storage.
carousel. Vials that are ineligible for onboard storage can be
processed in a vial rack or can be pipetted into sample
cups and processed in a sample rack.
Message code: 0358

Unable to create calibration order. Blank calibrator set lot (0) in rack (1) is missing or expired.
0 = Lot number
1 = Rack bar code
The blank calibrator set is missing or is expired. Configure a new calibrator lot. Perform Create a new
calibrator master lot (c‑series), page 311.
Message code: 0600

Operator ID (0) created by (1).
0 = Operator ID
1 = Operator ID of user who performed the action
A new operator ID was created. Status message. No corrective action is required.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 0601

(0) deleted for operator ID (1) by (2).
0 = PIN or password
1 = Operator ID
A PIN or a password was deleted for the operator ID. Status message. No corrective action is required.
Message code: 0602

(0) created for operator ID (1) by (2).
0 = PIN or password
1 = Operator ID
A PIN or a password was created for the operator ID. Status message. No corrective action is required.
Message code: 0603

Operator ID (0) inactivated by (1).
0 = Operator ID
The status for an operator ID changed from active to Status message. No corrective action is required.
inactive.
Message code: 0604

Operator ID (0) reactivated by (1).
0 = Operator ID
The status for an operator ID changed from inactive to Status message. No corrective action is required.
active.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 0605

Operator ID (0) changed from level (1) to level (2) by (3).
0 = Operator ID
1 = Original level name
2 = Current level name
The level for an operator ID was changed. Status message. No corrective action is required.
Message code: 0606

Operator ID (0) updated by (1).
0 = Operator ID
The first name or the last name of an operator ID was Status message. No corrective action is required.
changed.
Message code: 0607

Operator ID (0) logged on with a (1).
0 = Operator ID
1 = PIN or password
The user logged on. Status message. No corrective action is required.
Message code: 0608

Operator ID (0) logged off.
0 = Operator ID
The user was logged off because another user logged Status message. No corrective action is required.
on.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 0622

System automatically requested (0).
0 = Mail category
An automatic request for updated assay files was sent Status message. No corrective action is required.
to AbbottLink. When assay file versions are available, updates are sent
to Abbott Mail.
Message code: 0623

(0) (1) records archived.
0 = Number of records
1 = Archive report
The archive was completed. Status message. No corrective action is required.
Message code: 0626

System language changed from (0) to (1).
0 = Current language
1 = Updated language
The user configured a different language. Status message. No corrective action is required.
Message code: 0627

Instrument status transitioned to Offline.
The processing module is Offline. Start the processing module and the reagent and sample

80000071-105 - 2018-09-10
Troubleshooting
Message code: 0628

Communication between the computer and instrument established. Instrument status transitioned to
Stopped.
SCM communication was established with the Status message. No corrective action is required.
processing module.
Message code: 0656

No updated items downloaded for automatically requested (0).
0 = Mail category
An automatic request for updated items was sent to Status message. No corrective action is required.
AbbottLink and no updated items were available to
download.
Message code: 0657

Unable to request (0) automatically. A manual request is currently pending.
0 = Mail category
A manual request for assay files is pending. Only one Status message. No corrective action is required.
active request at a time can be performed. The automatic request is canceled and will be
performed in 7 days.
Message code: 0658

Operator ID (0) manually requested (1).
0 = Operator ID
1 = Mail category
A manual file request was performed. Status message. No corrective action is required.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 0659

System automatically requested the (1) for reagent lot (0).
0 = Reagent lot
1 = Mail category
A new reagent lot was scanned and an automatic Status message. No corrective action is required.
request for the assay insert was sent to AbbottLink.
Message code: 0660

(1) unavailable for reagent lot (0).
0 = Reagent lot
1 = Mail category
An error occurred when the assay insert was requested • To request the assay insert again, unload the
in Abbott Mail. reagent and reload the reagent.
• Refer to the assay insert that was shipped with the
reagent kit or obtain the appropriate insert at
The assay insert is not available in Abbott Mail. Refer to the assay insert that was shipped with the
Message code: 0661

Operator ID (0) accepted mail item (1) for (2) number (3) revision (4).
0 = Operator ID
1 = Mail category
2 = Subject
3 = List number
4 = Revision
The operator accepted a mail item. Status message. No corrective action is required.
Message code: 0662

Operator ID (0) accepted mail item (1) for (2) number (3).
0 = Operator ID

80000071-105 - 2018-09-10
Troubleshooting
1 = Mail category
2 = Subject
3 = TSB number
The operator accepted a system update. Status message. No corrective action is required.
Message code: 0663

Operator ID (0) declined mail item (1) for (2) number (3).
0 = Operator ID
1 = Mail category
2 = Subject
3 = TSB number
The operator declined a system update. Status message. No corrective action is required.
Message code: 0664

Operator ID (0) deleted mail item (1) for (2) number (3) revision (4).
0 = Operator ID
1 = Mail category
2 = Subject
3 = List number
4 = Revision
The operator deleted a mail item. Status message. No corrective action is required.
Message code: 0665

Operator ID (0) deleted mail item (1) for (2) number (3).
0 = Operator ID
1 = Mail category
2 = Subject
3 = TSB number
The operator deleted a system update. Status message. No corrective action is required.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 0666

Received mail item (0) for (1) number (2) revision (3).
0 = Mail category
1 = Subject
2 = List number
3 = Revision
A new Abbott Mail item was received. Status message. No corrective action is required.
Message code: 0667

Received mail item (0) for (1) number (2).
0 = Mail category
1 = Subject
2 = List number
A new Abbott Mail item was received. Status message. No corrective action is required.
Message code: 0679

(1) already exists for reagent lot (0).
0 = Reagent lot
1 = Mail category
A new reagent lot was loaded on the system. The assay Status message. No corrective action is required.
insert for the new reagent lot already exists on the
system and is assigned to reagent cartridges of the new
reagent lot.
Message code: 0680

Unable to accept mail item for (0) number (1) revision (2). (3) no longer available.
0 = Subject
1 = List number
2 = Revision

80000071-105 - 2018-09-10
Troubleshooting
3 = Mail category
The reagent lot that is associated with the assay insert Status message. The Abbott Mail item has been deleted.
is no longer stored on the system. The associated assay
insert has been deleted and is not available to be
accepted.
Message code: 0681

Processing module stopped during water bath automatic fill.
The water source supply was interrupted. 1. Verify that the water source supply is functioning.
2. Perform 4205 Flush Water Lines (c‑series), page
882.
The water source supply is restricted. 1. Verify that the tubing from the water source is not
crimped or blocked.
882.
The incoming purified water pressure is too low. Increase the incoming purified water pressure to be
within specifications.
failure.
Message code: 0682

Processing module status Stopped. (0) open.
0 = Cover
A processing module cover was opened during a run. 1. Close the processing module cover.
2. Restart the run.
A processing module cover was opened when a Tap OK on the screen. No corrective action is required.
diagnostic procedure was in process.
The processing module cover sensor failed. Contact Customer Service to resolve any hardware
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 0683

Processing module configured for exhibition mode.
The CPU board is configured for exhibition mode. Contact Customer Service to resolve any hardware
failure.
Message code: 0684

Unable to process test. Sample suspend requested.
The sample was suspended. The tests were sent to Rerun the sample. Perform Rerun a test or an exception
exception and not processed. for a specimen or control, page 703.
Message code: 0685

Reagent cartridge in position (0) has expired.
0 = Position
The reagent cartridge has expired. Load a new reagent cartridge. Perform Prepare reagent
cartridges, page 622 and Load cartridges on the reagent
Message code: 0686

Reagent cartridge in position (0) has exceeded onboard stability time.
0 = Position
The onboard stability time for the reagent cartridge has Load a new reagent cartridge. Perform Prepare reagent
been exceeded. cartridges, page 622 and Load cartridges on the reagent
Message code: 0689

Assay (0) number (1) version (2) is required for reagent lot (3) and is ready to be accepted from Abbott
Mail.

80000071-105 - 2018-09-10
Troubleshooting
0 = Assay name
1 = Assay number
2 = Assay version
3 = Reagent lot
The assay file version is not loaded on the system. 1. Download the assay file version from Abbott Mail.
Perform Manually request assay files, page 554.
2. Install the assay. Perform Install assay files, page
325.
Message code: 0690

Assay (0) number (1) version (2) is required for reagent lot (3) and is available for installation.
0 = Assay name
1 = Assay number
2 = Assay version
3 = Reagent lot
The required assay file version is not installed on the Install the required assay file. Perform Install assay files,
system. page 325.
Message code: 0691

Starting creation of weekly backup (0).
0 = Backup name
The weekly backup is in progress. Status message. No corrective action is required.
Message code: 0692

Starting creation of daily system backup (0).
0 = Backup name
The automatic daily backup is in progress. Status message. No corrective action is required.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 0693

Control configuration category (1) changed from (2) to (3) by operator ID (0).
0 = Operator ID
1 = Control configuration item
2 = Changed from
3 = Changed to
The control configuration was updated. Status message. No corrective action is required.
Message code: 0694

Control lot expired for control (0) lot (1).
0 = Control name
1 = Control lot
The control lot number that was scanned has expired. Load a new control lot number. Perform Prepare and
load calibrator and control vials into vial racks for
Message code: 0695

Control (0) lot (1) not found.
0 = Control name
1 = Control lot
The control is empty for the specified lot. Load a new control. Perform Prepare and load calibrator
and control vials into vial racks for onboard storage,
page 624.
A control lot is not configured for the SID. • Configure the correct control lot information.
Perform Manually create a new quality control lot,
page 349.
• Load a different control lot.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 0696

No reagent cartridge available to process control (0) lot (1) for assay (2) version (3) module (4).
0 = Control name
1 = Control lot
2 = Assay name
3 = Assay version
4 = Module
The required reagent cartridge is not loaded on the Load a reagent cartridge for the requested assay.
processing module.
Message code: 0697

Westgard rule (2) for assay (1) changed from (3) to (4) by operator ID (0).
0 = Operator ID
1 = Assay name
2 = Westgard rule
3 = Changed from
4 = Changed to
The Westgard rule configuration was updated. Status message. No corrective action is required.
Message code: 0698

Control configuration changed for (0) parameter (1) from (2) to (3) by operator ID (4).
0 = Control configuration item
1 = Parameter
2 = Changed from
3 = Changed to
4 = Operator ID
The control configuration was updated. Status message. No corrective action is required.
Message code: 0699

CPU firmware update in progress. Please wait.

80000071-105 - 2018-09-10
Troubleshooting

A CPU firmware update is in progress. Status message. No corrective action is required.
Message code: 0700

CPU firmware update complete. The system will automatically cycle power on the c‑series module.
The CPU firmware update is completed. Status message. No corrective action is required.
Message code: 0701

DAQ firmware update complete. Cycle power on the c‑series module to complete the update.
The DAQ firmware update is completed. Cycle power on the c‑series module to complete the
update. Perform Cycle power to the processing module
and the reagent and sample manager (RSM), page 484.
Message code: 0702

DAQ firmware update in progress. Please wait.
A DAQ firmware update is in progress. Status message. No corrective action is required.
Message code: 0703

Module (0) added.
0 = Module
A new module was added and configured. Status message. No corrective action is required.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 0704

(0) panel deleted.
0 = Panel
All assays within a panel have been deleted. Status message. No corrective action is required.
Message code: 0705

Assay uninstalled. (0) panel updated.
0 = Panel
An assay within a panel has been removed. Status message. No corrective action is required.
Message code: 0706

Reagent access cover removal detected.
The reagent access cover was removed. Replace the reagent access cover.
The reagent access cover sensor failed. Contact Customer Service to resolve any hardware
failure.
Message code: 0707

(0) assay result for SID (1) deleted by operator ID (2).
0 = Assay name
1 = SID
2 = Operator ID
The operator deleted an unreleased result. Status message. No corrective action is required.
Message code: 0708

Instrument status transitioned to (0).
0 = Instrument status

80000071-105 - 2018-09-10
Troubleshooting

The module status has changed. Status message. No corrective action is required.
Message code: 0709

Processing center cover opened.
One or both of the processing covers are open. 1. Close the processing cover that is open.
Message code: 0710

Automatically reposition samples for retest is disabled. System ordered retest will not be processed for
assay (0) SID (1).
0 = Assay name
1 = SID
The option to reposition samples automatically for To enable the option to reposition samples automatically
retesting was turned off. for retesting, perform Configure reagent and sample
manager module settings, page 189.
Message code: 0711

The same lot of this (0) is already available for installation for (1) LN (2) lot (3).
0 = Calibrator mail item
1 = Subject
2 = LN
3 = Lot
The operator attempted to accept a calibrator mail item Status message. No corrective action is required.
that is already available for installation.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 0712

The same lot of this (0) is already installed for (1) LN (2) lot (3).
0 = Calibrator mail item
1 = Subject
2 = LN
3 = Lot
The operator attempted to accept a calibrator mail item Status message. No corrective action is required.
that is already installed.
Message code: 0713

Received same lot of this (0) that is installed or available for install for (1) LN (2) lot (3).
0 = Mail category
1 = Subject
2 = LN
3 = Lot
The calibrator file was already available or installed Status message. No corrective action required.
before the AbbottLink request was sent.
Message code: 0714

Instrument status transitioned to offline while a maintenance or diagnostic procedure was running.
An unexpected error occurred during the running of the 1. Reinitialize the processing module. Perform Start
maintenance or diagnostic procedure. the processing module and the reagent and sample
2. Rerun the maintenance or diagnostic procedure.

failure.
occurred.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 0749

Suspend request denied for onboard vial rack (0) on module (1) reagent carousel position (2).
0 = Rack ID
1 = Module number
2 = Reagent carousel position
An onboard vial rack was selected to be suspended. Status message. No corrective action is required.
Onboard vial racks cannot be suspended.
Message code: 0750

Suspend request denied for onboard vial rack.
An onboard vial rack was selected to be suspended. Status message. No corrective action is required.
Onboard vial racks cannot be suspended.
Message code: 0758

Unreleased results are below capacity. Orders can be processed.
The number of unreleased results is less than the Status message. No corrective action is required.
maximum capacity.
Message code: 0759

Coolant lot number (0) replacement date (1) is approaching expiration date (2) on module (3).
0 = Coolant lot number
1 = Replacement date
2 = Expiration date
3 = Module
The coolant is nearing the expiration date. Contact Customer Service to replace the coolant.
NOTE: This message is generated approximately
28 days before the expiration date and is repeated
approximately every 7 days until the coolant is replaced
and the system is updated.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 0760

Coolant lot number (0) replacement date (1) expiration date (2) is expired on module (3).
0 = Coolant lot number
1 = Replacement date
2 = Expiration date
3 = Module
The coolant is expired. Contact Customer Service to replace the coolant.
Assay-specific message codes (1000-1999)

The assay-specific message code category includes message codes from 1000 through 1999.
1000, page 1112
1001, page 1112
1002, page 1112
1009, page 1113
1037, page 1113
1038, page 1114
1039, page 1115
1040, page 1116
1041, page 1117
1042, page 1118
1043, page 1119
1044, page 1121
1045, page 1122
1046, page 1122
1047, page 1122
1060, page 1123
1061, page 1124
1062, page 1124
1063, page 1125

80000071-105 - 2018-09-10
Troubleshooting
1064, page 1125

1065, page 1126
1066, page 1126
1067, page 1127
1068, page 1128
1069, page 1128
1070, page 1129
1071, page 1130
1072, page 1130
1075, page 1130
1076, page 1131
1082, page 1132
1092, page 1132
1093, page 1133
1094, page 1133
1095, page 1133
1096, page 1134
1097, page 1134
1098, page 1135
1099, page 1135
1100, page 1135
1101, page 1135
1102, page 1136
1103, page 1136
1104, page 1136
1105, page 1137
1106, page 1137
1107, page 1137
1108, page 1137
1109, page 1138
1110, page 1138
1111, page 1138
1113, page 1139
1116, page 1139
1117, page 1139
1118, page 1139
1119, page 1140
1120, page 1140
1122, page 1141

80000071-105 - 2018-09-10
Troubleshooting
1123, page 1141

1124, page 1142
1125, page 1142
1126, page 1142
1128, page 1143
1129, page 1143
1130, page 1143
1131, page 1143
1132, page 1144
1133, page 1144
1134, page 1144
1135, page 1144
1136, page 1145
1137, page 1145
1138, page 1145
1139, page 1146
1140, page 1146
1141, page 1146
1142, page 1146
1143, page 1147
1144, page 1147
1146, page 1147
1147, page 1148
1148, page 1148
1149, page 1148
1150, page 1149
1151, page 1149
1152, page 1149
1153, page 1150
1154, page 1150
1155, page 1150
1156, page 1151
1157, page 1151
1158, page 1151
1159, page 1151
1160, page 1152
1161, page 1152
1162, page 1152
1163, page 1153

80000071-105 - 2018-09-10
Troubleshooting
1164, page 1153

1165, page 1153
1166, page 1153
1167, page 1154
1169, page 1154
1170, page 1155
1171, page 1155
1172, page 1155
1173, page 1155
1174, page 1156
1180, page 1156
1182, page 1156
1183, page 1157
1184, page 1157
1185, page 1157
1186, page 1158
1187, page 1158
1188, page 1158
1400, page 1159
1401, page 1161
1402, page 1161
1403, page 1162
1404, page 1163
1405, page 1163
1406, page 1164
1415, page 1164
1423, page 1164
1424, page 1165
1600, page 1165
1601, page 1165
1602, page 1166
1603, page 1166
1604, page 1167
1605, page 1167
1606, page 1168
1607, page 1169
1608, page 1169
1609, page 1170
1610, page 1171

80000071-105 - 2018-09-10
Troubleshooting
1611, page 1171

1612, page 1172
1613, page 1172
1614, page 1173
1615, page 1173
Message code: 1000

Calibration failed for assay (0) number (1). Did not complete results for all calibrator levels.
0 = Assay name
1 = Assay number
The required number of replicates for a calibrator failed Review the specific message text for the calibrator
to complete because of an error. failure. Perform the corrective action for the specific
message text for the calibrator failure.
Message code: 1001

Calibration failed for assay (0) number (1). Calibrators incorrectly loaded.
0 = Assay name
1 = Assay number
The wrong calibrator was used or the calibrator was Place fresh calibrators into clean sample cups or tubes.
loaded incorrectly. Verify that the calibrators are placed in the correct
positions.
The calibrator is not performing as expected. Open a new calibrator.
The reagent is not performing as expected. Load a new reagent.
Message code: 1002

Calibration failed for assay (0) number (1). Unable to generate a calibration.
0 = Assay name
1 = Assay number
The reagent cartridge not is performing as expected. Load a new reagent.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 1009

Correlation assay (2) number (1) version (3) status updated to primary assay (5) number (4) version (6)
by operator ID (0).
0 = Operator ID
1 = Correlation assay number
2 = Correlation assay name
3 = Correlation assay version
4 = Primary assay number
5 = Primary assay name
6 = Primary assay version
The operator updated a correlation assay to a primary Status message. No corrective action is required.
assay.
Message code: 1037

Unable to calculate result. Rate reaction linearity failure.
The sample concentration is too high. Dilute and rerun the sample. For more information, see
The lamp was not seated correctly when it was Replace the lamp or the lamp plate (c‑series), page 937.
replaced. Perform Quarterly maintenance procedure 5806 Change
Lamp (c‑series), page 862:
• Ensure that the lamp is seated correctly against the
lamp plate and in the housing.
• Ensure that the lamp cables are secured by the
screws in terminal block.
The lamp is not performing as expected. Replace the lamp or the lamp plate (c‑series), page 937.
Perform Quarterly maintenance procedure 5806 Change
Lamp (c‑series), page 862.
The cuvettes are dirty. Clean the cuvettes. Perform Reaction Mechanisms
diagnostic procedure 5003 Clean Cuvettes - Manually
The cuvette washer is not functioning correctly. 1. Perform As-Needed maintenance procedure 5910
Wash Cuvettes (c‑series), page 867. Observe the
cuvette washer nozzles for drops or leaks.
2. Inspect the high-concentration waste pump tubing
for blockage.
a. Open the front processing center cover.
b. Locate the high-concentration waste pump.

80000071-105 - 2018-09-10
Troubleshooting

c. Inspect the input tubing from the cuvette
washer to the pump and the output tubing from
the pump to the high-concentrated waste. To
view the location of the high-concentration
waste pump, see Reaction carousel hardware
(Alinity c), page 83.
If a blockage is observed, contact Customer

Service.
The cuvette dry tip is damaged. Replace the cuvette dry tip (c‑series), page 945.
Debris is present in the water bath incubator. Perform Reaction Mechanisms diagnostic procedure
5005 Exchange Water in Bath (c‑series), page 890.
The R2 pipettor is out of alignment. Perform Pipettors diagnostic procedure 4104 R2 Pipettor
Calibration (c‑series), page 879.
Bubbles are present in the water bath incubator because Decrease the incoming purified water pressure to be
of the pressure of the incoming water. within specifications.
Bubbles are present in the water bath incubator because Contact Customer Service to resolve any hardware
of a high gas content of the incoming water. failure.
failure.
Message code: 1038

Unable to calculate result. Insufficient absorbance reads within absorbance range.
The sample is lipemic. Ultra-centrifuge the sample and rerun the infranatant.
For more information, see the assay documentation.
Bubbles or foam is present on the surface of the Allow the reagent cartridge to sit for the recommended
reagent. hold time to allow the bubbles or foam to dissipate. For
more information, see the assay documentation.
The reagent probe is damaged. Replace the reagent probes (c‑series), page 925.

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Troubleshooting

The reagent is not performing as expected. Load a new reagent cartridge.
for blockage.

Service.
failure.
Message code: 1039

Unable to calculate result. Absorbance exceeded optical limits.
An incorrect sample type was used. 1. Clean the cuvettes. Perform Weekly maintenance
procedure 5601 Clean Cuvettes with Detergent A
2. Load the correct sample type.
3. Repeat the test.

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Troubleshooting

for blockage.

Service.
failure.
Message code: 1040

Unable to calculate result. No absorbance reads within absorbance range.

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Troubleshooting

for blockage.

Service.
failure.
Message code: 1041

Unable to calculate result. Reaction check failure.

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Troubleshooting

NOTE: View the reaction graph to confirm the high
sample concentration. Perform View the reaction graph
and absorbance data for a result (c‑series), page 726.
Sample interferences (such as hemolysis or lipemia) Visually inspect the sample for possible interference
occurred. because of hemolysis, icterus, or turbidity, and then
perform one of the following actions:
• Redraw and rerun the sample if an interference is
observed.
• Rerun the sample if no interference is observed.
NOTE: View the sample interference indices to
determine increased interference levels, or view the
reaction graph to confirm abnormal absorbance
readings during the blank read time (compare the
error to a normal result). Perform View the reaction
graph and absorbance data for a result (c‑series),
page 726.
A high anticoagulant to plasma ratio is present (such as Redraw the sample into a anticoagulant tube that is
the sample tube is not filled adequately). adequately filled or use a serum sample. For more
If an error occurs for calibration samples:
The wrong calibrator was used or the calibrator was Place new calibrators into clean sample cups or tubes
loaded incorrectly. to ensure they are placed in the correct positions.
Repeat the calibration.
If an error occurs for all samples:
Message code: 1042

Unable to calculate result. ICT reference solution voltage drift error.

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Troubleshooting

The black electrical connector for the ICT module is Reseat the connection. Perform Replace the ICT module
loose or not connected. or the ICT probe (c‑series), page 952.
The ICT module O-rings are missing or are not seated Ensure that the ICT module O-rings are present and are
correctly, or extra O-rings from a previous ICT module seated correctly. If extra O-rings are present, remove
are present. them. If necessary, perform Replace the ICT module or
the ICT probe (c‑series), page 952.
The ICT probe is not connected correctly. Tighten the probe to the ICT module by hand. Perform
Replace the ICT module or the ICT probe (c‑series),
page 952.
The ICT aspiration tubing is not connected correctly. Tighten the tubing connections at the top of the ICT
module and at the top of the 1 mL syringes in the ICT
aspiration pump.
The ICT Reference Solution tubing is not connected Tighten the connections at the top and at the side of
correctly. each check valve in the ICT Reference Solution pump.
The ICT check valves are not connected correctly. Tighten the connections to the 1 mL syringes in the ICT
Reference Solution pump and in the ICT aspiration
pump.
The ICT check valves are not functioning. Perform Triannual maintenance procedure 5834 Check
and Change ICT Check Valves (c‑series), page 864.
The 1 mL syringes in the ICT aspiration pump or the ICT Reseat the 1 mL syringes.
Reference Solution pump are not seated correctly.
The 1 mL syringes in the ICT aspiration pump or the ICT Perform Triannual maintenance procedure 5833 Change
Reference Solution pump are leaking. 1 mL Syringes (c‑series), page 863.
The ICT module is expired or has exceeded its time or Replace the ICT module. Perform Replace the ICT
sample warranty (greater than 3 months after installation module or the ICT probe (c‑series), page 952.
or greater than 20,000 samples).
The ICT module is not performing as expected. Replace the ICT module. Perform Replace the ICT
module or the ICT probe (c‑series), page 952.
The ICT Reference Solution is not performing as 1. Replace the ICT Reference Solution bottle. Perform
expected. Replace bulk solutions and update the inventory,
page 579.
2. Perform ICT diagnostics procedure 5101 Flush ICT
Reference Solution Cup (c‑series), page 891.

failure.
Message code: 1043

Unable to calculate result. Final RLU read is outside the specification of the highest calibrator.

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Troubleshooting

The RLU read is outside the specifications for the
descending curve assay.
If an error occurs for one sample:
The sample contains an interfering substance. 1. See the section on limitations of the procedure and
specific performance characteristics in the assay-
specific documentation.
2. Redraw and rerun the sample if an interference is
observed.
A sample handling error occurred. • Follow the sample handling instructions in the
assay-specific documentation.
• Rerun the sample.
• Source a different sample.
If an error occurs for more than one sample:
The Pre-Trigger Solution and Trigger Solution tubing 1. Empty the reservoirs. Rinse the reservoirs and
assemblies are switched. floats with purified water, and then remove excess
water.
2. Replace the Pre-Trigger Solution and Trigger
Solution bottles. Perform Replace bulk solutions
and update the inventory, page 579.
3. Perform the Fluidics-Wash diagnostic procedure
1200 Flush and Prime Fluidics (i‑series), page 902.
The level sensor is not installed correctly. 1. Adjust the level sensor in the Pre-Trigger Solution
or Trigger Solution bottle so the level sensor is fully
seated in the reservoir.
2. Perform Fluidics-Wash diagnostic procedure 1200
Flush and Prime Fluidics (i‑series), page 902.
The Pre-Trigger Solution or Trigger Solution volume is Replace the Pre-Trigger Solution or Trigger Solution and
too low. update the inventory.
Hardware failure: Contact Customer Service to resolve any hardware
• The Pre-Trigger or Trigger pump failed. failure.
• The Pre-Trigger or Trigger valve failed.
• The Pre-Trigger or Trigger tubing connections are
loose.
• The temp-optics control board has a poor
connection or has failed.
• The optics failed.
• The shutter failed.
• The Pre-Trigger or Trigger manifold failed.
• The Pre-Trigger vortexer failed.

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Troubleshooting
Message code: 1044

Unable to calculate result. Final RLU read is outside the specification of the lowest calibrator.
The RLU read is outside the specifications for the
ascending curve assay.
If an error occurs for one sample:
Normal for some nonreactive samples. 1. Follow the sample handling instructions in the
2. Rerun the sample.
3. Source a different sample.
4. Contact Customer Service.
A sample handling error occurred. • Follow the sample handling instructions in the
• Source a different sample.
If an error occurs for more than one sample:
The Pre-Trigger Solution and Trigger Solution tubing 1. Empty the reservoirs. Rinse the reservoirs and
assemblies are switched. floats with purified water, and then remove excess
water.
2. Replace the Pre-Trigger Solution and Trigger
Solution bottles. Perform Replace bulk solutions
and update the inventory, page 579.
3. Perform the Fluidics-Wash diagnostic procedure
1200 Flush and Prime Fluidics (i‑series), page 902.
The Pre-Trigger Solution or Trigger Solution volume is Replace the Pre-Trigger Solution or Trigger Solution and
too low. update the inventory.
• The Pre-Trigger or Trigger pump failed. failure.
• The Pre-Trigger or Trigger valve failed.
• The Pre-Trigger or Trigger tubing connections are
loose.
• The temp-optics control board has a poor
connection or has failed.

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Troubleshooting

• The shutter failed.
• The Pre-Trigger or Trigger manifold failed.
• The Pre-Trigger vortexer failed.
Message code: 1045

An equal or higher version of this (3) is already available for installation for (0) number (1) revision (2).
0 = Subject
1 = List number
2 = Revision
3 = Mail category
The operator attempted to accept an assay file that is a • Accept the higher version of the assay file.
lower version than another unaccepted assay file. Only • To accept the lower version of the assay file,
the highest version of available assay files can be delete the higher version before accepting the
accepted. lower version.
Message code: 1046

An equal or higher version of this (3) is already installed for (0) number (1) revision (2).
0 = Subject
1 = List number
2 = Revision
3 = Mail category
The operator attempted to accept an assay file that is a Status message. To accept the lower version of the
lower version than another installed assay file. Only the assay file, perform one of the following corrective
highest version of available assay files can be accepted. actions:
• Uninstall the higher version of the assay file.
NOTE: When an assay file is uninstalled,
calibrations for the assay file and any assay
configuration including controls are deleted.
• Delete the assay file.
Message code: 1047

Received lower or equal version of an (3) than is installed or is available for install for (0) number (1)
revision (2).

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Troubleshooting
0 = Subject
1 = List number
2 = Revision
3 = Mail category
A manual request or an automatic request for an assay Status message. No corrective action is required.
file was in process. Before the system received the
assay file, an assay file of the same or higher version
was installed on the system.
Message code: 1060

Unable to calculate result. mV reading outside measurable range of ICT unit.
The black electrical connector for the ICT module is Reseat the black electrical connector to the ICT module.
loose or not connected.
page 952.
aspiration pump.
The ICT Reference Solution tubing is not connected Tighten the tubing connections at the top and at the side
correctly. of each check valve in the ICT Reference Solution
pump.
pump.
The ICT module is expired or has exceeded its time or Replace the ICT module or the ICT probe (c‑series),
sample warranty (greater than 3 months after installation page 952.
The ICT module is not performing as expected. Replace the ICT module or the ICT probe (c‑series),
page 952.

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Troubleshooting

failure.
Message code: 1061

Unable to calculate result. Endpoint absorbance reads unstable.
Debris or bubbles are present in the water bath because 1. Perform Reaction Mechanisms diagnostic
of the pressure or the high gas content of the incoming procedure 5005 Exchange Water in Bath (c‑series),
water. page 890.
2. Verify that the incoming purified water pressure is
within specifications.
3. If bubbles remain present, contact Customer
Service.
The lamp was not seated correctly when it was Repeat the lamp replacement procedure. Perform
replaced. Replace the lamp or the lamp plate (c‑series), page 937.
• Ensure the lamp is seated correctly against the
• Ensure the lamp cables are secured by the screws
in terminal block.
The lamp is not performing as expected. Perform Quarterly maintenance procedure 5806 Change
failure.
Message code: 1062

Unable to calculate result. Convergence error.
The sample absorbance lies between two segments of Rerun the sample.
the Spline calibration curve, and the result cannot be
calculated.
An invalid Spline calibration curve was generated. Recalibrate the assay.

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Troubleshooting
Message code: 1063

Unable to calculate result. Absorbance below calibration curve lower limit.
The sample concentration is too low. Rerun the sample.
replaced. Replace the lamp or the lamp plate (c‑series), page 937.
in terminal block.
failure.
Message code: 1064

Unable to calculate result. Absorbance exceeds highest calibrator.
The sample concentration is too high. Dilute and rerun the sample.
for blockage.

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Troubleshooting


Service.
failure.
Message code: 1065

Unable to calculate result. Flex read absorbance invalid for calibration.
The incorrect calibrator or calibrators were used, or the 1. Load the correct calibrator.
calibrator or calibrators were loaded incorrectly.
2. Repeat the calibration.

in terminal block.
failure.
Message code: 1066

Unable to calculate calibrator result. Insufficient absorbance reads within absorbance range.

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Troubleshooting

in terminal block.
The cuvettes are dirty. Perform Reaction Mechanisms diagnostic procedure
5003 Clean Cuvettes - Manually (c‑series), page 889.
for blockage.

Service.
failure.
Message code: 1067

Unable to calculate result. Absorbance collection error.

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Troubleshooting

in terminal block.
failure.
Message code: 1068

Unable to calculate result. Assay configuration error.
The combined sample and reagent volume is less than If the assay uses a photometric read point of less than
80 μL at a defined read time. 19, for any defined read time, verify that the combined
sample and reagent volume defined for the sample or
diluted sample, the R1 reagent, or the R1 water is
greater than or equal to 80 μL.
An assay parameter setting is defined incorrectly. Verify that the assay settings are configured correctly in
the assay parameter file. See Edit calibration settings of
assay parameters (c‑series photometric), page 293.
Message code: 1069

Unable to calculate result. Invalid mathematical calculation.
The sample concentration is too low. Rerun the sample.
replaced. Quarterly maintenance procedure 5806 Change Lamp
(c‑series), page 862:
The calibration is not optimal. Recalibrate the assay.

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Troubleshooting

failure.
Message code: 1070

Unable to calculate result. ICT Reference Solution voltage out of range.
page 952.
aspiration pump.
pump.
pump.
page 952.
The ICT Reference Solution is not performing as 1. Replace the ICT Reference Solution bottle. Perform
expected. Replace bulk solutions and update the inventory,
page 579.

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Troubleshooting

2. Perform ICT diagnostic procedure 5102 Flush ICT
Module (c‑series), page 892.

failure.
Message code: 1071

Unable to calculate result. Calibration curve allows multiple solutions.
failure.
Message code: 1072

Unable to calculate result. Processing module response outside of defined range.
occurred.
Message code: 1075

ICT measurement error for (0).
0 = Electrode

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Troubleshooting

page 952.
aspiration pump.
pump.
failure.
Message code: 1076

ICT DAC adjustment measurement range failed for (0).
0 = ICT DAC error
page 952.
aspiration pump.

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Troubleshooting

pump.
failure.
Message code: 1082

Unable to delete assay (1) number (0) version (2). A correlation assay (4) (3) version (5) exists.
0 = Assay number
1 = Assay name
2 = Assay version
3 = Correlation assay number
4 = Correlation assay name
5 = Correlation assay version
The operator attempted to delete a primary assay when • Configure the correlation assay to a primary assay.
a correlation assay exists for the same assay number. The previous primary assay is automatically
deleted.
• Delete the correlation assay first, and then delete
the primary assay.
Message code: 1092

Unable to process test. Assay number (0) version (1) not calibrated.
0 = Assay number
1 = Assay version

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Troubleshooting

An attempt was made to process a control or sample Calibrate the assay. Perform Create a calibration order,
when the assay is not calibrated. page 688.
Message code: 1093

Unable to process test. ICT module not configured.
An attempt was made to process an ICT sample when Configure the ICT module. Perform Configure c‑series
the ICT module is not configured on the processing module settings, page 189.
module.
Message code: 1094

Unable to process test. No reagent cartridge available for assay number (0) version (1).
0 = Assay number
1 = Assay version
The required reagent cartridge is not available on the Load a new reagent cartridge. Perform Load cartridges
selected processing module. All of the reagent kits on on the reagent and sample manager (RSM), page 599.
the module for the assay are empty, expired, not
calibrated, or disabled.
Message code: 1095

Westgard rule (0) failed for assay (1)/(2) control (3)/(5)/(4) on module (6).
0 = Westgard rule
1 = Assay name
2 = Assay version
3 = Control name
4 = Control lot
5 = Control level
6 = Module
A control received a Westgard rule failure flag. 1. Review the QC results for the specified control.
2. See Controls out of range (c‑series), page 1427 of
the sample results observed problems for the

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Troubleshooting

corrective action. See Controls out of range
(i‑series), page 1435 of the sample results
observed problems for the corrective action.
3. Rerun the same control level or levels after the
corrective action is performed.
Message code: 1096

Westgard rule (0) warning for assay (1)/(2) control (3)/(5)/(4) on module (6).
0 = Westgard rule
1 = Assay name
2 = Assay version
3 = Control name
4 = Control lot
5 = Control level
6 = Module
A control received a Westgard rule warning flag. 1. Review the QC results for the specified control.
2. See Controls out of range (c‑series), page 1427 of
the sample results observed problems for the
corrective action. See Controls out of range
(i‑series), page 1435 of the sample results
observed problems for the corrective action.
3. Rerun the same control level or levels after the
corrective action is performed.
Message code: 1097

Unable to delete assay (0) from control (1). Pending orders exist for this assay.
0 = Assay
1 = Control
An attempt was made to delete an assay when pending Delete the pending order or wait until the orders are
or running orders exist for the assay. completed before the assay is deleted.

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Troubleshooting
Message code: 1098

Unable to delete assay (0) from Control (1) / Level (3) / Lot (2). Pending orders exist for this assay.
0 = Assay
1 = Control name
2 = Control level
3 = Control lot
An attempt was made to delete an assay when pending Delete the pending order or wait until the orders are
or running orders exist for the assay. completed before the assay is deleted.
Message code: 1099

Unable to process test. Constituent assay (0) number (1) can not be system ordered. System ordering
disabled.
0 = Constituent assay
1 = Constituent assay number
The calculated assay that was ordered does not support Order the calculated assay and the constituent assay
constituent assays ordered by the system. with the correct dilutions.
Message code: 1100

Unable to process test. Constituent assay (0) number (1) can not be system ordered. Offline dilution not
supported.
A calculated assay was ordered for a manually diluted Order the calculated assay for a sample that is
sample. The calculated assay has a constituent assay undiluted or that uses an automated dilution protocol.
that does not support a manual dilution.
Message code: 1101

Unable to process test. Constituent assay (0) number (1) can not be system ordered. Assay disabled.
0 = Assay name
1 = Assay number

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Troubleshooting

The constituent assay is disabled. 1. Enable the required assay. Perform Edit general
settings of assay parameters (c‑series photometric),
page 286, Edit general settings of assay parameters
(c‑series potentiometric), page 289, or Edit general
settings of assay parameters (i‑series), page 290.
2. Rerun the test.
Message code: 1102

Unable to calculate result. Constituent assay (0) number (1) result not found.
A constituent result was deleted before other Reorder the constituent assay.
constituents of a calculated result completed.
The constituent result was flagged outside the Rerun the constituent assay with a manual or automatic
configured measurement range of the assay. dilution if one is available. Perform Rerun a test or an
One of the constituent results became an exception. 1. Determine and correct the cause of the exception.
Message code: 1103

Unable to calculate result. Constituent assay (0) number (1) result out of range.
A constituent result was outside the constituent range Status message. No corrective action is required.
that is specified in the calculated assay parameters.
Message code: 1104

Unable to calculate result. No constituent results exist to calculate results.

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Troubleshooting

The constituent results that are required for the Rerun the constituent assays and the calculated assay.
calculated result are not found. Perform Rerun a test or an exception for a specimen or
control, page 703.
Message code: 1105

Unable to calculate result. More than one reagent lot used to process constituent assays.
Constituent assays of a calculated assay that use the 1. Verify that adequate inventory of the same reagent
same reagent cartridge were not run on the same lot is on the reagent carousel.
reagent lot number.
2. Rerun the calculated assay. Perform Rerun a test
or an exception for a specimen or control, page
703.
Message code: 1106

Unable to process test. Primary indirect (0) assay result not found.
0 = Assay
A primary indirect photometric test replicate was not Repeat the test order.
found.
Message code: 1107

Unable to process test. Secondary indirect (0) assay result not found.
0 = Assay
A secondary indirect photometric test replicate was not Repeat the test order.
found.
Message code: 1108

Unable to calculate result. Constituent result not available.

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Troubleshooting

A constituent result was deleted before other Reorder the constituent assay.
constituents of a calculated result completed.
The constituent result was flagged outside the Rerun the constituent assay with a manual or automatic
configured measurement range of the assay. dilution if one is available. Perform Rerun a test or an
One of the constituent results became an exception. 1. Determine and correct the cause of the exception.
Message code: 1109

Unable to calculate result. (0) result exceeds maximum allowable limit.
0 = Result
The calculated result cannot be determined because the Modify the calculated result formula or constituent assay
result exceeds the numerical limit. ranges. Perform Create a calculated assay, page 302.
Message code: 1110

Unable to process test. Required number of probe washes not completed.
The required number of probe washes did not occur. Rerun a test or an exception for a specimen or control,
page 703.
Message code: 1111

Unable to delete assay from calibrator set (0). Pending orders exist.
0 = Calibrator set
A pending order exists for the calibrator set. Complete or delete the pending orders before the assay
from the calibrator set is deleted.

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Troubleshooting
Message code: 1113

Unable to delete calibrator set (0). Pending orders exist.
0 = Calibrator set
A pending order exists for the calibrator set. Complete or delete the pending orders before the
calibrator set is deleted.
Message code: 1116

Configuration for calibrator set (0) parameter (1) edited from (2) to (3) by operator ID (4).
0 = Calibrator set
1 = Parameter
2 = Original value
3 = New value
4 = Operator ID
A calibrator set parameter has been modified. Status message. No corrective action is required.
Message code: 1117

Assay (0) number (1) version (2) edited by operator ID (3).
0 = Assay name
1 = Assay number
2 = Assay version
3 = Operator ID
One or more assay parameters have been modified. Status message. No corrective action is required.
Message code: 1118

Unable to install assay (1) number (0) version (2). Primary and correlation versions already installed.
0 = Assay number
1 = Assay name
2 = Assay version

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Troubleshooting

The operator attempted to install a newer version of an 1. To select the appropriate primary assay, perform
assay and the assay already has primary and correlation one of the following steps:
versions that are installed. – Replace the primary assay with the installed
correlation assay. Perform Change the assay
status of a correlation assay, page 301.
– Uninstall the correlation assay. Perform
Uninstall assay files, page 327.
2. Install the new correlation assay. Perform Install
assay files, page 325.
Message code: 1119

Calibration failed for assay (0) lot (1) on module (2). System shutdown occurred.
0 = Assay name
1 = Lot
2 = Module
An unexplained system shutdown occurred. Cycle power to the system, page 480.
occurred.
Message code: 1120

Unable to process order for (1) control lot (0) assay (2) version (3). Assay not installed.
0 = Control lot
1 = Control level
2 = Assay name
3 = Assay version
The assay is not installed on the system. Install the assay on the system and configure the control
lot before the order is processed. Perform Install assay
files, page 325 and Manually create a new quality
control lot, page 349.

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Troubleshooting
Message code: 1122

Unable to create calibration order for cal set (0) lot (1). Some of the calibrator levels not loaded, are
unusable or processing module is not available.
0 = Calibrator set
1 = Calibrator lot
Some calibrator vial levels are not loaded in the rack. Load all required calibrator vial levels in the rack.
Perform Load racks on the reagent and sample manager
(RSM), page 595.
The processing module is not in the Running status. Verify that the processing module is in the Running
status.
The assay is not enabled. On the Assay Parameters screen, tap Enabled or
Patient Disabled in the Assay Availability drop-down
list.
A scanned calibrator vial has a vial status of Expired. Replace the calibrator vial.
A scanned calibrator vial has a vial status of Empty or Replace the calibrator vial.
LLS Error.
The sample probe is out of alignment. Verify that the targets and the probe are clean. Perform
Pipettors diagnostic procedures 4102 Sample Pipettor
Calibration (c‑series), page 878 and 1111 Sample
Pipettor Check and Calibration (i‑series), page 895.
Message code: 1123

Unable to calculate result. Assay is not calibrated.
No reagent cartridges are calibrated for the assay. 1. Calibrate the assay for the reagent cartridge.
Perform Prepare and load calibrator and control
vials into vial racks for immediate use, page 646
and Load racks on the reagent and sample manager
(RSM), page 595.
A calibration failed when an order was in process. 1. Calibrate the assay for the reagent cartridge.
Perform Prepare and load calibrator and control
vials into vial racks for immediate use, page 646
and Load racks on the reagent and sample manager
(RSM), page 595.

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Troubleshooting
Message code: 1124

Unable to process test. Calibrators not loaded in the same rack.
All calibrator vial levels are not loaded in the same rack. 1. Verify that all calibrator vial levels are loaded in the
same rack. Perform Prepare and load calibrator and
control vials into vial racks for immediate use, page
646.
2. Load the rack on the reagent and sample manager.
Perform Load racks on the reagent and sample
Message code: 1125

Reagent cartridge in position (0) disabled due to control failure.
The reagent cartridge was disabled by the system 1. Review the results for the specific control.
because of a quality control failure.
2. Rerun the same control level for the specific
reagent cartridge.
3. Load and run a new control sample. Perform
Prepare and load calibrator and control vials into
vial racks for immediate use, page 646 and Load
racks on the reagent and sample manager (RSM),
page 595.
Message code: 1126

Unable to process test. Calibrator lot (0) for assay number (1) version (2) expired.
0 = Calibrator lot
1 = Assay number
2 = Assay version
The calibrator lot is expired. Load a new calibrator lot. Perform Prepare and load
calibrator and control vials into vial racks for immediate
use, page 646 and Load racks on the reagent and

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Troubleshooting
Message code: 1128

Unable to add calculated assay. The calculation formula (0) is invalid.
0 = Formula
A valid formula is not entered for a calculated assay. Enter a valid formula for the calculated assay. Perform
Create a calculated assay, page 302.
Message code: 1129

Unable to create order for (2) control level (1) lot (0). Control lot expired.
0 = Control lot
1 = Control level
2 = Control name
The control lot is expired. Manually create a new quality control lot, page 349.
Message code: 1130

Unable to create order for (2) control level (1) lot (0). No expiration date configured for control lot.
0 = Control lot
1 = Control level
2 = Control name
The control lot configuration is missing a required Manually create a new quality control lot, page 349.
expiration date.
Message code: 1131

Invalid order for (2) control level (1) lot (0). Order exists for rack ID (3) position (4).
0 = Control lot
1 = Control level
2 = Control name
3 = Rack ID
4 = Position

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Troubleshooting

An order already exists for the rack or position. • Process the existing order.
• Reorder the test by using a different position or
rack.
Message code: 1132

Reagent cartridge at location (0) re-enabled by control set (1) level (2).
0 = Location
1 = Control set
2 = Level
The QC is within range. The reagent cartridge has been Status message. No corrective action is required.
re-enabled.
Message code: 1133

No control order created for (2) level (1) lot (0).
0 = Control lot
1 = Control level
2 = Control name
No control order is due. Status message. No corrective action is required.
Message code: 1134

Reagent cartridge in position (0) disabled by operator (1).
1 = Operator ID
The operator disabled a reagent cartridge. Status message. No corrective action is required.
Message code: 1135

Reagent cartridge in position (0) re-enabled by operator (1).

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Troubleshooting
1 = Operator ID
The operator enabled a reagent cartridge. Status message. No corrective action is required.
Message code: 1136

Reagent cartridge stability for assay (0) lot (1) SN (2) has been updated with Alinity PRO data.
0 = Assay name
1 = Lot
2 = SN
The reagent cartridge stability has been updated with Status message. No corrective action is required.
Alinity PRO data.
Message code: 1137

Reagent cartridge test count for assay (0) lot (1) SN (2) has been updated with Alinity PRO data.
0 = Assay name
1 = Lot
2 = SN
The reagent cartridge test count has been updated with Status message. No corrective action is required.
Alinity PRO data.
Message code: 1138

Reagent cartridge liquid level for assay (0) lot (1) SN (2) has been updated with Alinity PRO data.
0 = Assay name
1 = Lot
2 = SN
The reagent cartridge liquid level has been updated with Status message. No corrective action is required.
Alinity PRO data.

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Troubleshooting
Message code: 1139

Calibrator stability for assay (0) lot (1) SN (2) has been updated with Alinity PRO data.
0 = Assay name
1 = Lot
2 = SN
The calibrator stability has been updated with Alinity Status message. No corrective action is required.
PRO data.
Message code: 1140

Calibrator test count for assay (0) lot (1) SN (2) has been updated with Alinity PRO data.
0 = Assay name
1 = Lot
2 = SN
The calibrator test count has been updated with Alinity Status message. No corrective action is required.
PRO data.
Message code: 1141

Control stability for assay (0) lot (1) SN (2) has been updated with Alinity PRO data.
0 = Assay name
1 = Lot
2 = SN
The control stability has been updated with Alinity PRO Status message. No corrective action is required.
data.
Message code: 1142

Control test count for assay (0) lot (1) SN (2) has been updated with Alinity PRO data.
0 = Assay name
1 = Lot
2 = SN

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Troubleshooting

The control test count has been updated with Alinity Status message. No corrective action is required.
PRO data.
Message code: 1143

Retest rule (0) for assay (1) number (2) version (3) deleted because all target assays have been
deleted.
0 = Retest rule
1 = Assay name
2 = Assay number
3 = Assay version
The system was unable to perform the retest rule. The Install the required assays to complete the retest rule.
required assays are not installed. Perform Install assay files, page 325.
Message code: 1144

Retest rule (0) for assay (1) number (2) version (3) modified because an assay required for this rule was
deleted.
0 = Retest rule
1 = Assay name
2 = Assay number
3 = Assay version
The system was unable to perform the retest rule. The Install the required assays to complete the retest rule.
required assays were deleted. Perform Install assay files, page 325.
Message code: 1146

Reagent cartridge assay (0) lot (1) SN (2) inventory information is questionable. Cartridge will not be
tracked for inventory sharing.
0 = Assay name
1 = Lot
2 = SN
Inventory tracking is invalid for the specified reagent Manual inventory tracking is required for the reagent
cartridges: cartridges.

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Troubleshooting

• A two-cartridge reagent set does not match the set
in Alinity PRO.
• The reagent cartridge was loaded on a different
instrument, and the reagent cartridge unload was
not recorded.
Message code: 1147

Calibrator for assay (0) lot (1) SN (2) inventory information is questionable. Calibrator will not be tracked
for inventory sharing.
0 = Assay name
1 = Lot
2 = SN
Inventory tracking is invalid for the specified calibrator: Manual inventory tracking is required for the calibrator
• The calibrator bottle serial number does not match lot.
the serial number in Alinity PRO.
• The calibrator has been loaded on another
instrument, and the calibrator unload was not
recorded.
Message code: 1148

Control for assay (0) lot (1) SN (2) inventory information is questionable. Control will not be tracked for
inventory sharing.
0 = Assay name
1 = Lot
2 = SN
Inventory tracking is invalid for the specified control: Manual inventory tracking is required for the control lot.
• The control bottle serial number does not match
the serial number in Alinity PRO.
• The control has been loaded on another instrument,
and the control unload was not recorded.
Message code: 1149

Automated calibration order failed for calibrator set (0) lot (1) level (2).

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Troubleshooting
0 = Calibrator set
1 = Calibrator lot
2 = Calibrator level
The calibration order failed for the specified calibrator Additional messages that are associated with this
set. message can be used to determine the appropriate
Message code: 1150

Calibrator set (0) lot (1) expired.
0 = Calibrator set
1 = Calibrator lot
The calibrator lot is expired. • Use a different calibrator lot.
• Configure a new calibrator lot. Perform Create a
new calibrator master lot (c‑series), page 311 or
Create a new calibrator master lot (i‑series), page
313.
Message code: 1151

Operator ID (0) manually failed calibration.
0 = Operator ID
The operator manually failed a calibration. Status message. No corrective action is required.
Message code: 1152

Calibrator lot mismatch.
The calibrator order does not match the calibrator vial Create the calibration order using the correct lot
lot number. number. Perform Create a calibration order, page 688.

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Troubleshooting
Message code: 1153

Unable to process test. Onboard calibrators or controls not available for rack ID (0).
0 = Rack ID
The onboard calibrator vials or control vials have a vial 1. Remove the onboard vial rack if it is loaded in the
status of Empty or Expired. reagent carousel or remove it from the reagent and
sample manager (RSM).
2. Replace the empty or expired vials with new
calibrator vials or control vials. Perform Prepare
and load calibrator and control vials into vial racks
for onboard storage, page 624 and Load racks on
An aspiration error occurred for one or more vials and 1. Remove the onboard vial rack if it is loaded in the
the vial status is LLS Error. reagent carousel or remove it from the RSM.
2. Remove all bubbles or foam from the sample by
using a clean disposable pipette or applicator stick.
Message code: 1154

Onboard vial (0) is (1).
0 = Vial bar code
1 = Vial status
The indicated onboard vial volume is almost empty. Verify vial inventory data, page 591.
Message code: 1155

Unable to process test. Error in formula (0) for calculated assay.
0 = Calculated assay formula
The formula for the calculated assay is incorrect. Verify the formula configured for the calculated assay.
Perform Create a calculated assay, page 302.
occurred.

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Message code: 1156

Unable to create control order. Invalid control lot (0) or level (1).
0 = Control lot
1 = Control level
The control lot or level scanned is not configured. Configure the control for the lot number and level.
Perform Manually create a new quality control lot, page
349.
Message code: 1157

Remaining tests for assay (0) lot (1) SN (2) has been updated with Alinity PRO data.
0 = Assay name
1 = Lot
2 = SN
The remaining tests have been updated with Alinity PRO Status message. No corrective action is required.
data.
Message code: 1158

(0) lot (1) SN (2) has invalid inventory sharing data. Material will not be tracked for inventory sharing.
0 = Calibrator or control name
1 = Calibrator or control lot
2 = SN
Inventory tracking is invalid for the specified calibrator or Manually track the calibrator or control inventory.
control:
• Inventory tracking is invalid for the specified
calibrator or control.
• Calibrator or control bottle serial number does not
match the bottle serial number in Alinity PRO.
Message code: 1159

(0) lot (1) SN (2) stability has been updated with Alinity PRO shared inventory data.

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Troubleshooting
2 = SN
The calibrator or control stability has been updated with Status message. No corrective action is required.
Alinity PRO data.
Message code: 1160

Remaining tests for (0) lot (1) SN (2) has been updated with Alinity PRO data.
2 = SN
The remaining tests for the calibrator or control have Status message. No corrective action is required.
been updated with Alinity PRO data.
Message code: 1161

(0) lot (1) SN (2) status updated. Status (3) stability (4).
2 = SN
3 = Status
4 = Stability
The calibrator or control expiration or stability status has Status message. No corrective action is required.
been updated with Alinity PRO data.
Message code: 1162

Retest rule (0) deleted for assay (1) number (2) version (3). No target assays installed.
0 = Retest rule name
1 = Assay name
2 = Assay number
3 = Assay version
The retest rule was deleted. Status message. No corrective action is required.

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Troubleshooting
Message code: 1163

Target assay (0) deleted from retest rule (1) for assay (2) number (3) version (4). Target assay no
longer installed.
0 = Target assay name
1 = Retest rule
2 = Assay name
3 = Assay number
4 = Assay version
A target assay for a retest rule was deleted. Status message. No corrective action is required.
Message code: 1164

Onboard stability time was lowered to (1) for calibration set (0).
0 = Onboard stability time
1 = Calibration set name
The onboard stability time for a calibration set was Status message. No corrective action is required.
edited by the operator.
Message code: 1165

Calibration expired for assay (0) lot (1) on module (2).
0 = Assay name
1 = Lot
2 = Module
The calibration has exceeded the expiration date for the Calibrate the reagent lot again.
assay.
Message code: 1166

Calibration failed for assay (0) lot (1) on module (2).
0 = Assay name
1 = Lot

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Troubleshooting
2 = Module
The wrong calibrator was used or the calibrator was 1. Place new calibrator vials into racks or new
loaded incorrectly. calibrator into clean sample cups or tubes. Verify
that the vials are placed in the correct positions.
The calibrators are not performing as expected. 1. Open new calibrator bottles or vials.
The reagent is not performing as expected. 1. Load a new reagent cartridge. Perform Load
cartridges on the reagent and sample manager
(RSM), page 599
Message code: 1167

No calibration exists for assay (0) lot (1) on module (2).
0 = Assay name
1 = Lot
2 = Module
There is no active calibration for the assay on the Calibrate the assay for the specified lot on the module.
module.
Message code: 1169

Reagent cartridge (0) in reagent carousel position (1) is empty.
0 = Reagent cartridge
The required reagent cartridge is empty, and no other Load a new reagent cartridge for the required assay.
reagent cartridges are loaded on the reagent carousel Perform Load cartridges on the reagent and sample
for this assay. manager (RSM), page 599

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Troubleshooting
Message code: 1170

Reagent cartridge in reagent carousel positions (3) are low. Remaining test count is (2).
2 = Remaining tests
The remaining tests for the reagent cartridge are low. Load a new reagent cartridge for the required assay.
Perform Load cartridges on the reagent and sample
manager (RSM), page 599
Message code: 1171

Control failures for assay (0) control (1) lot (2) level (3) on module (4) were cleared by operator ID (5).
Comment (6).
0 = Assay name
1 = Control name
2 = Control lot
3 = Control level
4 = Module
5 = Operator ID
6 = Comment
The control failures for the specified assays were Status message. No corrective action is required.
cleared by the operator.
Message code: 1172

Configuration for onboard cal / QC positions have changed. At least one reagent carousel position has a
reagent cartridge or rack loaded in the position.
The configured onboard Cal and QC positions are Unload the reagent cartridge or rack that is occupying
occupied by a reagent cartridge or rack. the reserved positions. Perform Unload reagents from
the reagent and sample manager (RSM), page 633 and
Load cartridges on the reagent and sample manager
(RSM), page 599).
Message code: 1173

(0) material (1) is expired.

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Troubleshooting
0 = Vial material
1 = Vial bar code
The vial material is expired. Load new vial material. Perform Prepare and load
calibrator and control vials into vial racks for immediate
use, page 646
Message code: 1174

Unable to delete assay (1) number (0) version (2). Instrument status must be Offline, Stopped, or Idle.
0 = Assay number
1 = Assay name
2 = Assay version
The operator attempted to delete an assay when the Transition the instrument to a status of Idle, Stopped, or
instrument was not in the correct status. Offline to delete an assay.
Message code: 1180

Automated calibration canceled. Calibration scheduled for calibrator set (0) lot (1) level (2) during a
batch run.
0 = Calibrator set name
1 = Calibrator lot number
The automated calibration for the specified calibrator • Complete the batch run and reorder the calibration.
set, lot number, and level was scheduled during a batch • If the calibration is required immediately, terminate
run. the batch run in process and order the calibration.
Message code: 1182

Unable to process test. The assay has exceeded the onboard stability.
The onboard control vials have exceeded the onboard Load new onboard control vials. Perform Prepare and
stability. load calibrator and control vials into vial racks for

80000071-105 - 2018-09-10
Troubleshooting
Message code: 1183

Unable to install assay (0) number (1) version (2). Previous version (4) included result unit (3).
0 = Assay name
1 = Assay number
2 = Assay version
3 = Result unit
4 = Previous assay version
The operator attempted to install an assay whose Contact Customer Service. Provide information about
previous version included an additional result unit. the operation that was attempted when the error
occurred.
Message code: 1184

Unable to calculate result. More than one module processed the constituent assays.
Constituent assays of a calculated assay control were 1. Verify that the constituent assays of the derived
not run on the same processing module. control order were run on the same processing
module.
2. Rerun the calculated assay control. Perform Rerun
a test or an exception for a specimen or control,
page 703.
Message code: 1185

Control (0) lot (1) level (2) for assay (3) time interval has expired. Load specified control.
0 = Control name
1 = Control lot
2 = Control level
3 = Assay name
The time interval for the control has expired. Load control vials. Perform Prepare and load calibrator
and control vials into vial racks for immediate use, page
646.

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Troubleshooting
Message code: 1186

Control (0) lot (1) level (2) for assay (3) test count interval has been exceeded. Load specified control.
0 = Control name
1 = Control lot
2 = Control level
3 = Assay name
The test count interval for the control has exceeded the Load control vials. Perform Prepare and load calibrator
configured limit. and control vials into vial racks for immediate use, page
646.
Message code: 1187

Unable to process test. Induction heating is required but the hardware is not present on the module.
A test was ordered for an assay that requires induction 1. Verify that the induction heating hardware is not
heating, but the induction heating hardware has not installed on the processing module. See Induction
been installed on the processing module. heater wash cup (Alinity i), page 126.
2. Contact Customer Service to install the induction
heating hardware on the processing module.
Message code: 1188

(0) number (1) version (2) was disabled on module (3) due to missing or incompatible hardware.
0 = Assay name
1 = Assay number
2 = Assay version
3 = Module ID
An assay that was installed and enabled on the 1. If the assay was loaded in error on the processing
processing module requires induction heating, but the module, perform Uninstall assay files, page 327.
induction heating hardware has not been installed on the
2. If the assay was not loaded in error on the
processing module or the hardware is not compatible for
processing module, perform the following steps:
induction heating.

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Troubleshooting

a. Confirm that the installed assay requires
induction heating. For more information, see
the assay-specific reagent package insert.
b. Contact Customer Service to install the
induction heating hardware on the processing
module.
c. Ensure that the assay is re-enabled after
installation.

failure.
Message code: 1400

Calibration failed for assay (0) number (1). (2).
0 = Assay name
1 = Assay number
2 = Validity check name
The wrong calibrator was used or the calibrator was Place fresh calibrators into clean sample cups or tubes.
loaded incorrectly. Verify that the calibrators are placed in the correct
positions.
Calibrator replacement caps were reused. After calibrator vials are opened, seal the vials with new
replacement caps after each use before the vials are
stored.
The reagent was stored incorrectly. Load a new reagent.
The reagent is contaminated. Load a new reagent.
The reagent was not mixed correctly when it was 1. Upon receipt, gently invert the unopened reagent kit
received. by rotating it over and back for a full 180 degrees,
five times with the green label stripe facing up and
then five times with the green label stripe facing
down. This process ensures that the liquid covers
all sides of the bottles within the cartridges. During
reagent shipment, microparticles can settle on the
reagent cartridge septum.
2. Refer to the assay documentation for additional
assay-specific mixing instructions.
Bubbles are present in the tubing. Perform Fluidics-Wash diagnostic procedure 1200 Flush
and Prime Fluidics (i‑series), page 902.

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Troubleshooting

The Pre-Trigger Solution or the Trigger Solution level Replace the appropriate level sensor as required.
sensor is cracked. Perform Replace the level sensor for Pre-Trigger
Solution, Trigger Solution, or Concentrated Wash Buffer
The tubing connections are loose. Tighten the tubing connections.
The Pre-Trigger Solution or the Trigger Solution Perform Fluidics-Wash diagnostic procedure 1210 Pre-
dispense is inadequate. Trigger Precision and Accuracy (i‑series), page 905 or
1211 Trigger Precision and Accuracy (i‑series), page
906.
The wash zone probes are not seated correctly in the Reseat the wash zone probes. Perform Replace the
probe block assembly. wash zone probes (i‑series), page 1001.
The diluted wash buffer level sensor assembly is Replace the diluted wash buffer level sensor (i‑series),
cracked or leaking. page 1014.
The wash zone probes are bent or damaged. Replace the wash zone probes (i‑series), page 1001.
The wash buffer dispense at the wash zones is Perform Fluidics-Wash diagnostic procedure 1221 Wash
inadequate. Zone 1 Precision and Accuracy (i‑series), page 906 or
1222 Wash Zone 2 Precision and Accuracy (i‑series),
page 906.
The sample probe is not positioned correctly. Perform the Calibration option of the Pipettors
diagnostic procedure 1111 Sample Pipettor Check and
Calibration (i‑series), page 895.
The pipettor probes are not straight. Perform the Probe Straightness option of the Pipettors
Calibration (i‑series), page 895, 1112 R1 Pipettor Check
and Calibration (i‑series), page 895, or 1113 R2 Pipettor
Check and Calibration (i‑series), page 896.
The probe is not positioned correctly. Perform Pipettors diagnostic procedure 1111 Sample
Pipettor Check and Calibration (i‑series), page 895, 1112
R1 Pipettor Check and Calibration (i‑series), page 895,
or 1113 R2 Pipettor Check and Calibration (i‑series),
page 896.
The probe is dirty or partially obstructed. • Perform Fluidics-Wash diagnostic procedure 1200
Flush and Prime Fluidics (i‑series), page 902 and
observe that the pipettors dispense liquid and no
leaks or bubbles are observed in the tubing.
• Replace the appropriate probe. Perform Replace a
sample or reagent pipettor probe (i‑series), page
998.
The probe is damaged. Replace the appropriate probe. Perform Replace a
sample or reagent pipettor probe (i‑series), page 998.
The water quality is below specifications. Verify that the purified water purity is within
specifications.
The pipettor aspiration or dispense is insufficient. Perform Pipettors diagnostic procedure 1120 Sample
Pipettor Syringe Precision and Accuracy (i‑series), page
897, 1121 R1 Pipettor Syringe Precision and Accuracy

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Troubleshooting

(i‑series), page 897, or 1122 R2 Pipettor Syringe
Precision and Accuracy (i‑series), page 898.
The Pre-Trigger Solution or the Trigger Solution is not Empty the Pre-Trigger Solution reservoir or the Trigger
performing as expected. Solution reservoir and replace the Pre-Trigger Solution
or the Trigger Solution. Perform Fluidics-Wash
diagnostic procedure 1209 Empty Bulk Solution
Reservoirs (i‑series), page 905.
• The wash zone assembly is leaking. failure.
• Static electricity is present.
• The vortexer failed.
Message code: 1401

Unable to process test. Background read failure.
The ambient light level is too high. • Verify that all the system panels are correctly
installed.
• Block the system from direct sunlight.
or the Trigger Solution.
failure.
Message code: 1402

Unable to process test. Activated read failure.
or the Trigger Solution.
The Pre-Trigger and Trigger bulk solution level sensors • Perform Empty the bulk solution reservoirs
or tubing was switched. (i‑series), page 1456 to empty the bulk solution
reservoirs for both the Trigger Solution and the Pre-
Trigger Solution.
• Perform Fluidics-Wash diagnostic procedure 1200
Flush and Prime Fluidics (i‑series), page 902 for
Trigger Solution and Pre-Trigger Solution.

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Troubleshooting

installed.
failure.
Message code: 1403

Unable to process test. Final read failure.
installed.

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Troubleshooting

906.
or the Trigger Solution. Perform Fluidics-Wash
diagnostic procedure 1209 Empty Bulk Solution
Reservoirs (i‑series), page 905.
failure.
Message code: 1404

Calibration failed for assay (0) number (1). Correlation coefficient out of range.
0 = Assay name
1 = Assay number
Message code: 1405

Calibration failed for assay (0) number (1). Intercept out of range.
0 = Assay name
1 = Assay number

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Troubleshooting
Message code: 1406

Calibration failed for assay (0) number (1). Cal 1 or Cal 2 final read below specifications.
0 = Assay name
1 = Assay number
Message code: 1415

Calibration for assay (1) reagent lot (2) on module (3) expires in (0) hours.
0 = Number of hours
1 = Assay name
2 = Lot
3 = Module
The calibration expires in the specified number of hours. 1. Prepare and load the appropriate calibrators in a
rack. Perform Prepare and load calibrator and
control vials into vial racks for immediate use, page
646.
2. Load the rack on the reagent and sample manager.
Perform Load racks on the reagent and sample
Message code: 1423

Unable to process test. Calibrators are not loaded in the positions defined by the calibration order.
A manual calibration order was created and calibrators Load the calibrators in the correct rack positions defined
were not loaded in the correct rack positions. by the manual calibration order.

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Troubleshooting
Message code: 1424

Unable to process cal set (0) lot (1) level (2). Calibrators are not loaded in the positions defined by the
existing calibration order for the cal set.
0 = Calibrator set name
1 = Calibrator lot number
A manual calibration order was created and calibrators • Load the calibrator vials in the correct vial rack
were not loaded in the correct vial rack positions. positions defined by the manual calibration order.
• Delete the manual calibration order. Perform Delete
a test from a sample order, page 692.
Message code: 1600

Calibration failed for assay (0) number (1). Assay configuration error.
0 = Assay name
1 = Assay number
The combined sample and reagent volume is less than If the assay uses a photometric read point of less than
80 μL at a defined read time. 19, for any defined read time, verify that the combined
sample and reagent volume defined for the sample or
diluted sample, the R1 reagent, or the R1 water is
greater than or equal to 80 μL.
The assay has been configured with no calibrator set 1. Select or configure a calibrator set for the assay.
when one was previously defined.
2. Recalibrate the assay.
An assay setting is defined incorrectly. Verify that the assay configuration settings are
configured correctly. See Edit calibration settings of
assay parameters (c‑series photometric), page 293.
Message code: 1601

Calibration failed for assay (0) number (1). Convergence error.
0 = Assay name
1 = Assay number
Bubbles or foam is present on the surface of the Remove all bubbles or foam from the sample by using a
sample. clean disposable pipette or applicator stick.

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Troubleshooting

The incorrect calibrator was used, or the calibrator was 1. Load the correct calibrator.
loaded incorrectly.
The reaction mode is incorrectly defined. Select the appropriate reaction mode.
The dispense system is not performing correctly. Verify that the dispense components are functioning
correctly.
failure.
Message code: 1602

Calibration failed for assay (0) number (1).
0 = Assay name
1 = Assay number
The required assay parameter is not defined for a Compare the following assay parameter settings to the
c‑series assay. default assay parameter settings to determine which
parameter is missing a value:
• All calibrator value fields (including blank and water
concentration)
• Blank absorbance range lower limit
• Blank absorbance range upper limit
• Expected calibration factor
• Expected calibration factor tolerance percent
• Span absorbance range lower limit
• Span absorbance range upper limit
Software error. If the error continues, contact Customer Service. Provide
information about the operation that was attempted
when the error occurred.
Message code: 1603

Calibration failed for assay (0) number (1). Calibrator deviation too large.
0 = Assay name
1 = Assay number

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Troubleshooting

Bubbles are present in the calibrator sample cup. Remove any bubbles from the sample cup.
correctly.
The calibrator is not performing as expected. Load a new calibrator.
failure.
Message code: 1604

Calibration failed for assay (0) number (1). Maximum curve fit too large.
0 = Assay name
1 = Assay number
The incorrect calibrator was used, or the calibrator was 1. Load the correct calibrator in the correct order.
loaded incorrectly.
correctly.
failure.
Message code: 1605

Calibration failed for assay (0) number (1). Calibration factor out of range.
0 = Assay name
1 = Assay number
The calibrator concentration values are incorrectly Verify that the correct values for the lot number of the
defined. calibrator are used.

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Troubleshooting

loaded incorrectly.
The calibrators were on the system for an extended Load new calibrators into clean sample cups or tubes.
period of time.
correctly.
The expected cal factor or expected cal factor tolerance If a re-evaluation of the expected cal factor is needed
percent values need to be re-evaluated. for the laboratory, perform the following steps:
1. Collect cal factor values from multiple calibration
curves, or review calibration curve details reports
for recent historical curves. (A thorough study
requires multiple cartridges and multiple reagent
lots.) During this collection period, ensure the
control values that are run against those cal factors
are in range and do not display trends or shifts.
2. Average the acceptable cal factors, and enter the
mean in the expected cal factor field.
3. If the average expected cal factor is correct and
the control values have been in range, consider
slightly increasing the expected cal factor tolerance
percent.

failure.
Message code: 1606

Calibration failed for assay (0) number (1). Slope outside of defined range.
0 = Assay name
1 = Assay number
The incorrect calibrator was used, or the calibrator was 1. Load the correct calibrator in the correct order.
loaded incorrectly.

80000071-105 - 2018-09-10
Troubleshooting

The ICT probe is not connected correctly. Tighten the tubing connections at the top of the ICT
aspiration pump.
pump.
pump.
page 952.
failure.
Message code: 1607

Calibration failed for assay (0) number (1). Insufficient calibrator replicates.
0 = Assay name
1 = Assay number
The required number of replicates for a calibrator failed Review the specific message text to determine the
to complete because of an error. reason for the failed calibrator replicates. Refer to the
Message code: 1608

Calibration failed for assay (0) number (1). Invalid mathematical calculation.
0 = Assay name

80000071-105 - 2018-09-10
Troubleshooting
1 = Assay number
loaded incorrectly.
correctly.
failure.
Message code: 1609

Calibration failed for assay (0) number (1). Blank absorbance out of range.
0 = Assay name
1 = Assay number
specifications.
The calibrator is not performing as expected if the blank Load a new calibrator.
calibrator is defined to use a zero concentration
calibrator rather than water.
The cuvettes are dirty. Perform Reaction Mechanisms diagnostic procedure
5003 Clean Cuvettes - Manually (c‑series), page 889.

80000071-105 - 2018-09-10
Troubleshooting

failure.
Message code: 1610

Calibration failed for assay (0) number (1). Defined span out of range.
0 = Assay name
1 = Assay number
Bubbles are present in the calibrator sample cup. Remove any bubbles from the sample cup.
loaded incorrectly.
correctly.
failure.
Message code: 1611

Calibration failed for assay (0) number (1). Slope too low.
0 = Assay name
1 = Assay number
loaded incorrectly.

80000071-105 - 2018-09-10
Troubleshooting

page 952.
aspiration pump.
The ICT Reference Solution tubing is not connected Tighten the connections at the top and at the side of
correctly. each check valve in the ICT Reference Solution pump.
pump.
page 952.
failure.
Message code: 1612

Calibration failed for assay (0) number (1). Results not completed for all calibrator levels.
0 = Assay name
1 = Assay number
The required number of replicates for a calibrator failed Review the specific message text for the failed
to complete because of an error. calibrator replicates. Perform the the corrective action
for the specific message text.
Message code: 1613

Calibration failed for assay (0) number (1). Concentration out of range for ICT index.
0 = Assay name

80000071-105 - 2018-09-10
Troubleshooting
1 = Assay number
The incorrect index calibrator was used for calibration. Load the correct calibrator.
The index calibrator is not performing as expected. Load new calibrator vials.
The index concentration or index range is defined Define the correct index concentration and index range
incorrectly. in the assay parameters.
Message code: 1614

Calibration failed for assay (0) number (1). Insufficient calibrator replicates.
0 = Assay name
1 = Assay number
The required number of replicates for a calibrator failed Review the specific message text for the failed
to complete because of an error. calibrator replicates. Perform the the corrective action
for the specific message text.
Message code: 1615

Unable to perform adjustment calibration. No full calibration exists for assay (0) number (1) version (2)
reagent lot (3).
0 = Assay name
1 = Assay number
2 = Assay version
3 = Reagent lot
A full calibration does not exist for the specified assay. Perform a full calibration. Perform Create a calibration
order, page 688.
Maintenance and diagnostic message codes (2000-2999)

The maintenance and diagnostic message code category includes message codes from 2000
through 2999.

80000071-105 - 2018-09-10
Troubleshooting
2050, page 1176

2057, page 1176
2058, page 1176
2059, page 1176
2060, page 1177
2062, page 1177
2075, page 1177
2076, page 1178
2077, page 1178
2081, page 1178
2082, page 1178
2083, page 1179
2084, page 1179
2085, page 1179
2087, page 1179
2089, page 1180
2090, page 1180
2091, page 1180
2092, page 1181
2093, page 1181
2094, page 1181
2095, page 1182
2096, page 1182
2100, page 1182
2101, page 1183
2102, page 1183
2103, page 1183
2104, page 1183
2105, page 1184
2121, page 1184
2122, page 1184
2123, page 1184
2124, page 1185
2500, page 1185
2501, page 1186
2502, page 1186
2503, page 1186
2505, page 1186
2506, page 1187

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Troubleshooting
2507, page 1187

2509, page 1187
2510, page 1188
2511, page 1188
2512, page 1188
2513, page 1189
2514, page 1189
2515, page 1189
2516, page 1189
2517, page 1190
2518, page 1190
2519, page 1190
2520, page 1191
2521, page 1191
2522, page 1192
2523, page 1192
2524, page 1192
2525, page 1192
2526, page 1193
2527, page 1193
2528, page 1193
2529, page 1194
2530, page 1194
2531, page 1194
2532, page 1195
2533, page 1195
2534, page 1195
2535, page 1196
2536, page 1196
2537, page 1196
2538, page 1197
2539, page 1197
2558, page 1197
2559, page 1197
2560, page 1198
2561, page 1198
2562, page 1198

80000071-105 - 2018-09-10
Troubleshooting
Message code: 2050

Run request denied. Insufficient supply inventory.
Insufficient inventory exists to process tests. Load the required inventory items on the system and
The diluted wash buffer reservoir is empty. The corrective action for the specific message text.
instrument was unable to dilute the wash buffer. • Contact Customer Service to resolve any hardware
failure.
Message code: 2057

High concentration waste bottle full.
The high-concentration waste bottle is full. Empty the high-concentration waste bottle and update
the inventory (c‑series), page 583.
The high-concentration waste bottle float switch is dirty. Perform Triannual maintenance procedure 5835 Check
and Clean High-Concentration Waste Sensor (c‑series),
page 864.
The float switch cable has a poor connection. Reseat the float switch cable to the module and to the
high-concentration waste bottle.
The float switch cable failed. Replace the float switch cable.
The float switch failed. Replace the high-concentration waste bottle.
Message code: 2058

Alkaline Wash empty.
The Alkaline Wash reservoir and the Alkaline Wash Replace the Alkaline Wash bottle. Perform Replace bulk
bottle are empty. solutions and update the inventory, page 579.
Message code: 2059

Acid Wash empty.

80000071-105 - 2018-09-10
Troubleshooting

The Acid Wash reservoir and the Acid Wash bottle are Replace Acid Wash bottle. Perform Replace bulk
empty. solutions and update the inventory, page 579.
Message code: 2060

RV waste chute full.
The RV waste chute is designed to hold approximately 1. Replace the empty solid waste container.
50 used reaction vessels when the solid waste container
2. Update the Supplies screen if necessary.
is removed to be emptied.
failure.
Message code: 2062

Unable to process test. ICT Reference Solution empty.
The ICT Reference Solution bottle is empty. Replace the ICT Reference Solution bottle. Perform
579.
NOTE: The replacement of a new lot number of ICT
Reference Solution must be performed in the Idle status.
Message code: 2075

Unable to transfer ICT Reference Solution to reservoir. (0).
0 = Transfer error
579.

failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 2076

Reagent carousel scan error.
Message code: 2077

ICT module has expired.
The ICT module is expired. Replace the ICT module. Perform Replace the ICT
Message code: 2081

Run request denied for module (1). (0) empty.
0 = Inventory item
1 = Module
The indicated inventory item supply is empty. Load the required inventory items on the system and
Message code: 2082

Run request denied for module (0). (1) expired.
0 = Inventory item
1 = Module
The indicated inventory item supply is expired. Load the required inventory items on the system and

80000071-105 - 2018-09-10
Troubleshooting
Message code: 2083

Expiration date updated for (0) to (1) for module (2).
0 = Inventory item
1 = Expiration date
2 = Module
A new inventory item was loaded on the system and the Status message. No corrective action is required.
inventory was updated.
The indicated inventory item expiration date was Status message. No corrective action is required.
changed by the operator.
Message code: 2084

Lot updated for (0) to (1) for module (2).
0 = Inventory item
1 = Updated lot
2 = Module
A new inventory item was loaded on the system and the Status message. No corrective action is required.
inventory was updated.
The indicated inventory item lot number was changed by Status message. No corrective action is required.
the operator.
Message code: 2085

Processing module (0) status changed to Pausing. Liquid waste container full.
0 = Module
The liquid waste container is full. Empty and replace the liquid waste container. Perform
Verify the supply and waste inventory, page 579.
Message code: 2087

(0) level low on module (1).

80000071-105 - 2018-09-10
Troubleshooting
0 = Inventory item
1 = Module
The indicated inventory item supply is low. Load the required inventory items on the system and
Message code: 2089

RV waste container full on module (0).
0 = Module
The RV waste container is full. Remove the RV waste and update the inventory (i‑series),
page 584.
Message code: 2090

(0) lot (1) expired on processing module (2).
0 = Inventory item
1 = Lot
2 = Module
The indicated inventory item is expired. Load the required inventory items on the system and
The indicated bulk solution is expired in the bulk solution Empty the bulk solution reservoir and transfer the new
reservoir. bulk solution. Perform one of the following procedures
based on the bulk solution:
• Empty the bulk solution reservoirs (c‑series), page
1452
• Empty the bulk solution reservoirs (i‑series), page
1456
• Empty the diluted wash buffer reservoir (i‑series),
page 1460
Message code: 2091

(0) lot (1) onboard stability expired on module (2) .
0 = Inventory item

80000071-105 - 2018-09-10
Troubleshooting
1 = Lot
2 = Module
The indicated inventory stability is expired. Load the required inventory items on the system and
The indicated bulk solution is expired in the bulk solution Empty the bulk solution reservoir and transfer the new
reservoir. bulk solution. Perform one of the following procedures
based on the bulk solution:
• Empty the bulk solution reservoirs (c‑series), page
1452
• Empty the bulk solution reservoirs (i‑series), page
1456
• Empty the diluted wash buffer reservoir (i‑series),
page 1460
Message code: 2092

Replace supply for (0) lot (1) on module (2).
0 = Inventory item
1 = Lot
2 = Module
A new bulk solution bottle was scanned or the lot Replace the required bulk solution on the system.
number and expiration date were entered manually. Perform Replace bulk solutions and update the inventory,
page 579.
Message code: 2093

ICT module replaced on module (0). Previous ICT module SN (1) had sample count of (3) and days on
board (2).
The ICT module replacement procedure is completed. Status message. No corrective action is required.
Message code: 2094

(0) reservoir empty.
0 = Bulk solution reservoir

80000071-105 - 2018-09-10
Troubleshooting

The bulk solution bottle reservoir is empty. Replace bulk solutions and update the inventory, page
579.
failure.
Message code: 2095

No (0) bottle loaded in bulk solution storage area.
0 = Bulk solution
The bulk solution bottle inventory is empty, has reached Replace bulk solutions and update the inventory, page
the onboard stability expiration date, or is expired. 579.
failure.
Message code: 2096

RV waste container near full on module (0).
0 = Module ID
The RV waste container is near capacity. Remove the RV waste and update the inventory (i‑series),
page 584.
Message code: 2100

Unable to process test. Bulk solution (0) insufficient or expired.
0 = Bulk solution
The bulk solution inventory is empty or expired. Replace bulk solutions and update the inventory, page
579.
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 2101

Module (1) (0) inventory discrepancy. Update supplies.
0 = Inventory item
1 = Module
The expected inventory does not match the available On the processing module, repeat Initiate or resume
inventory because of a database restore or service sample processing, page 648.
activity.
failure.
Message code: 2102

Module (1) (0) inventory empty.
0 = Inventory item
1 = Module
The specified inventory is empty. Load the required inventory items on the system and
Message code: 2103

ICT module warranty expired for SN (1) on module (0). (2) days onboard. (3) samples processed.
0 = Module
1 = Serial number
2 = Days on board
3 = Samples processed
The ICT module has exceeded its time or sample Replace the ICT module. Perform Replace the ICT
warranty of 3 months on the system or 20,000 samples. module or the ICT probe (c‑series), page 952.
Message code: 2104

(1) inventory low on module (0). Module is pausing.
0 = Module
1 = Bulk solution

80000071-105 - 2018-09-10
Troubleshooting

The specified inventory item is almost empty. Verify the supply and waste inventory, page 579.
Message code: 2105

Onboard solution lot (0) created for (1).
0 = Onboard solution lot
1 = Onboard solution
A new onboard solution lot number was created. Status message. No corrective action is required.
Message code: 2121

RSM transport theta calibration error.
Hardware failure. • Additional messages that are associated with this
failure.
Message code: 2122

RSM transport theta calibration concurrent move error.
failure.
Message code: 2123

Calibration failed during (0) pipettor LLS check.

80000071-105 - 2018-09-10
Troubleshooting
0 = Pipettor
The probe is dirty. Clean the appropriate probe.
The pipettor RV calibration target is dirty. Clean the pipettor RV calibration target.
The pipettor LLS cable is disconnected. Verify that the pipettor LLS cable and tubing assembly
are connected correctly.
The probe tubing connection is leaking. Clean and tighten the probe tubing connection fitting.
• The LLS sensor cable is loose or disconnected. failure.
• The probe tubing connector is damaged.
• The LLS antenna board is wet.
• The pipettor control board is defective.
• The pipettor LLS cable and tubing assembly are
damaged.
Message code: 2124

(0) transfer complete. Stability days reduced from (1) to (2) days due to reservoir stability limitation.
0 = Inventory type
1 = Original stability days
2 = Effective stability days
The onboard stability time was reduced for the bulk Status message. No corrective action is required.
solution inventory after a transfer from a bulk solution
bottle on the door to a bulk solution reservoir was
completed.
Message code: 2500

(0) (1) version (2) uninstalled by (3).
0 = Procedure number
1 = Procedure name
2 = Procedure version
3 = Operator ID
The selected procedure was uninstalled. Status message. No corrective action is required.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 2501

Unable to install (0) (1) version (2). A higher version already installed.
1 = Procedure name
A higher version of the procedure is already installed. • No corrective action is required if the request was
made in error.
• To install a lower version, uninstall the procedure
and then install the necessary version.
Message code: 2502

(0) (1) version (2) installed.
1 = Procedure name
The selected procedure was installed. Status message. No corrective action is required.
Message code: 2503

Unable to uninstall (0) (1) version (2). Procedure is in process.
1 = Procedure name
The operator attempted to uninstall a procedure while Uninstall the procedure after the procedure is
the procedure is in process. completed.
Message code: 2505

User canceled (0) (1).
1 = Procedure name

80000071-105 - 2018-09-10
Troubleshooting

The operator canceled the procedure. Status message. No corrective action is required.
Message code: 2506

Unable to install (0) (1) version (2). Procedure is running.
1 = Procedure name
An installation was attempted while a procedure is Perform the installation after the procedure is
running. completed.
Message code: 2507

(0) (1) failed.
1 = Procedure name
A system error message occurred. • Review the message text for the error indicated in
the Activity box or Results box on the Perform
Procedure screen. Perform the corrective action for
the specific error message text.
• If the procedure is completed and is not running,
the message text can be reviewed for the specific
procedure in the Details for Log flyout on the Logs
screen.
The acceptance criteria that is specified in the Correct the issue that caused the failure and repeat the
procedure was not met. procedure.
Message code: 2509

System software version not compatible. Requires version (0). Version (1) is installed.
0 = Software version required
1 = Software version installed

80000071-105 - 2018-09-10
Troubleshooting

The procedure requires a newer version of system Contact Customer Service. Provide information about
software. the operation that was attempted when the error
occurred.
Message code: 2510

User-defined maintenance procedure (0) (1) version (2) created by (3).
1 = Procedure name
3 = Operator ID
A user-defined maintenance procedure was created. Status message. No corrective action is required.
Message code: 2511

User-defined maintenance procedure (0) (1) version (2) updated by (3).
1 = Procedure name
3 = Operator ID
A user-defined maintenance procedure was updated. Status message. No corrective action is required.
Message code: 2512

(0) (1) version (2) exported to (3).
1 = Procedure name
3 = USB flash drive
A user-defined maintenance procedure was exported. Status message. No corrective action is required.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 2513

One or more maintenance procedures are overdue. System is pausing.
A maintenance procedure is overdue. Perform any overdue maintenance procedures.
Message code: 2514

User selected (0) (1) version (2) to be excluded from the import.
1 = Procedure name
A procedure was excluded from the import. Status message. No corrective action is required.
Message code: 2515

Unable to perform (0) (1) version (2). Procedure is running on module (3).
1 = Procedure name
3 = Module
The maintenance or diagnostic procedure is already in 1. Wait until the procedure is completed.
progress.
2. To end the procedure, tap Quit on the screen.
Message code: 2516

Unable to perform (0) (1) version (2). Module (3) is in an incorrect state.
1 = Procedure name
3 = Module
The module is not in the correct status that is defined in Transition the module to the correct status to perform
the maintenance or diagnostic procedure. the procedure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 2517

Unable to perform (0) (1) version (2). Procedure is in process.
1 = Procedure name
The procedure is already in process. Status message. No corrective action is required.
Message code: 2518

Unable to install procedure. English language file corrupted or not found.
The maintenance or diagnostic procedure file is Repeat the installation with a new copy of the
corrupted. procedure.
occurred.
Message code: 2519

Sample pipettor calibration failed.
The cuvette alignment tool is not seated correctly in the Reseat the cuvette segment alignment tool on the
reaction carousel. alignment pins in the reaction carousel. Install the
cuvette alignment tool in the reaction carousel.
The cuvette alignment tool is not present. Install the cuvette alignment tool in the reaction
carousel.
The pipettor cover, the probe screw, or the probe 1. Remove the pipettor cover.
ground wire screw is loose.
2. Tighten the probe screw and the probe ground wire
screw with a slotted screwdriver.
3. Replace the pipettor cover and verify that the cover
is seated firmly on the end of the pipettor shaft.
The sample probe is dirty or is damaged. • Clean the sample probe.

• Replace the sample probe (c‑series), page 922.

80000071-105 - 2018-09-10
Troubleshooting

failure.
Message code: 2520

R1 pipettor calibration failed.
carousel.
The R1 pipettor cover, the probe screw, or the probe 1. Remove the pipettor cover.
The R1 probe is dirty or is damaged. • Clean the R1 probe.

• Replace the reagent probes (c‑series), page 925.
failure.
Message code: 2521

R2 pipettor calibration failed.
carousel.
The R2 pipettor cover, the probe screw, or the probe 1. Remove the pipettor cover.

80000071-105 - 2018-09-10
Troubleshooting

The R2 probe is dirty or is damaged. • Clean the R2 probe.
• Replace the reagent probes (c‑series), page 925.
failure.
Message code: 2522

Reagent carousel calibration failed.
The reagent carousel calibration failed. Perform Reagent Manager diagnostic procedure 4703
Reagent Supply Center Test (c‑series), page 887.
failure.
Message code: 2523

Reagent transport calibration failed.
failure.
Message code: 2524

Light beam alignment failed.
failure.
Message code: 2525

Instrument status is displayed as Maintenance. While running a procedure the instrument status was
internally changed to (0).
0 = Instrument status

80000071-105 - 2018-09-10
Troubleshooting

The instrument is in the Maintenance status. Status message. No corrective action is required.
Message code: 2526

Procedure (0) (1) version (2) installed successfully. Unable to copy files to internal location.
1 = Procedure name
The system was unable to copy the procedure to an Contact Customer Service. Provide information about
internal hard drive after the procedure was installed the operation that was attempted when the error
from a USB flash drive. occurred.
Message code: 2527

Unable to install library file (0). (1) error.
0 = File name
1 = Error
occurred.
Message code: 2528

(1) error occurred processing (0) system update package.
0 = System update package file
1 = Error
An error occurred when the maintenance and diagnostic Reinstall the system update package that contains the
procedure file was installed during a system update. maintenance and diagnostic procedure file.
occurred.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 2529

(0) pipettor calibration error.
0 = Pipettor
The pipettor calibration failed. The probe is out of Verify that the targets and the probe are clean. Perform
alignment. Pipettors diagnostic procedure 1111 Sample Pipettor
Check and Calibration (i‑series), page 895, 1112 R1
Pipettor Check and Calibration (i‑series), page 895, or
1113 R2 Pipettor Check and Calibration (i‑series), page
896.
The probe is damaged. Replace a sample or reagent pipettor probe (i‑series),
page 998.
Hardware failure. Review the specific message text. Perform the
Contact Customer Service to resolve any hardware
failure.
Message code: 2530

(0) positioner calibration error.
0 = Positioner
failure.
Message code: 2531

(0) pipettor ground calibration error.
0 = Pipettor
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 2532

(0) pipettor reagent carousel calibration error.
0 = Pipettor
The pipettor calibration failed. The probe is out of Verify that the targets and the probe are clean. Perform
alignment. Pipettors diagnostic procedure 1112 R1 Pipettor Check
and Calibration (i‑series), page 895 or 1113 R2 Pipettor
The probe is damaged. Replace the R1 or R2 pipettor probe. Perform Replace a
Hardware failure. Review the specific message text. Perform the
failure.
Message code: 2533

(0) positioner lane calibration error.
0 = Positioner
failure.
Message code: 2534

RV loader upper hopper empty.
The RV loader upper hopper is empty. Replenish reaction vessels (RVs) and update the
inventory (i‑series), page 586.
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 2535

Reagent carousel and transport calibration error.
failure.
Message code: 2536

Probe straightness check failed. Offsets (0).
0 = Offsets
The probe failed the straightness check of the probe Repeat Pipettors diagnostic procedure 1111 Sample
calibration procedure. Pipettor Check and Calibration (i‑series), page 895, 1112
page 896.
The probe is damaged. Replace the probe. Perform Replace a sample or
reagent pipettor probe (i‑series), page 998.
failure.
Message code: 2537

Calibration target not found.
The calibration target was not found. Repeat Pipettors diagnostic procedure 1111 Sample
page 896. During the calibration, verify that all
calibration targets are cleaned with water (purified or
tap).
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 2538

Reagent carousel calibration failed.
A hardware error occurred. The reagent carousel Additional messages that are associated with this
calibration failed. message can be used to determine the appropriate
Message code: 2539

Reagent carousel and reagent transport calibration failed.
The reagent carousel and the reagent transport Additional messages that are associated with this
calibration failed. message can be used to determine the appropriate
Message code: 2558

R1 pipettor exceeded maximum inner offset during R1 pipettor calibration. Offset (0) range (1) to (2).
0 = Offset value
1 = Minimum offset
2 = Maximum offset
The R1 pipettor calibration failed at the R1 inner reagent Confirm that the R1 pipettor wash cup is installed
position. correctly. Repeat Pipettors diagnostic procedure 4103
R1 Pipettor Calibration (c‑series), page 878.
failure.
Message code: 2559

Cuvette washing not completed, hardware failure or user pressed Stop. Promptly perform procedure
5910 Wash Cuvettes.

80000071-105 - 2018-09-10
Troubleshooting

The operator selected the Stop button before the Perform As-Needed maintenance procedure 5910 Wash
cuvette washing was completed. Cuvettes (c‑series), page 867.
failure.
Message code: 2560

(0) (1) version (2) was obsoleted.
1 = Procedure name
A maintenance or diagnostic procedure was uninstalled Status message. No corrective action is required.
and deleted during a software startup or a system
update.
Message code: 2561

Unable to obsolete file: (0). (1) error occurred.
0 = File name
1 = Error message
Software error. 1. Cycle power to the system, page 480.
2. If the error continues, contact Customer Service.
Provide information about the operation that was
attempted when the error occurred.
Message code: 2562

(0) error occurred reading the obsolete file.
0 = Error message
occurred.

80000071-105 - 2018-09-10
Troubleshooting
Level sense and fluidics message codes (3000-3999)

The level sense and fluidics message code category includes message codes from 3000
through 3999.
3002, page 1203
3003, page 1203
3004, page 1203
3005, page 1203
3006, page 1204
3007, page 1205
3008, page 1205
3009, page 1206
3010, page 1206
3011, page 1206
3012, page 1207
3013, page 1207
3014, page 1208
3019, page 1208
3020, page 1209
3021, page 1209
3022, page 1210
3023, page 1210
3033, page 1211
3034, page 1211
3035, page 1212
3036, page 1212
3037, page 1213
3038, page 1213
3039, page 1214
3041, page 1214
3042, page 1214
3043, page 1215
3044, page 1215

80000071-105 - 2018-09-10
Troubleshooting
3045, page 1216

3046, page 1216
3047, page 1217
3048, page 1217
3049, page 1217
3050, page 1218
3051, page 1219
3052, page 1220
3058, page 1220
3201, page 1221
3202, page 1221
3203, page 1221
3213, page 1222
3214, page 1222
3215, page 1223
3302, page 1223
3303, page 1223
3304, page 1224
3305, page 1224
3306, page 1224
3307, page 1224
3308, page 1224
3309, page 1225
3310, page 1225
3316, page 1225
3317, page 1225
3319, page 1226
3320, page 1226
3417, page 1226
3418, page 1226
3420, page 1227
3421, page 1227
3422, page 1227
3423, page 1228
3424, page 1228
3425, page 1228
3426, page 1228
3427, page 1229
3428, page 1230

80000071-105 - 2018-09-10
Troubleshooting
3429, page 1230

3430, page 1230
3431, page 1231
3436, page 1231
3437, page 1232
3446, page 1233
3447, page 1234
3449, page 1234
3450, page 1235
3451, page 1235
3452, page 1236
3453, page 1236
3454, page 1237
3455, page 1237
3457, page 1237
3458, page 1238
3459, page 1238
3460, page 1239
3462, page 1239
3463, page 1240
3471, page 1240
3472, page 1240
3473, page 1241
3474, page 1241
3475, page 1241
3601, page 1242
3603, page 1242
3604, page 1242
3607, page 1243
3608, page 1243
3609, page 1243
3610, page 1244
3611, page 1244
3612, page 1244
3613, page 1245
3614, page 1245
3615, page 1245
3616, page 1246
3617, page 1246

80000071-105 - 2018-09-10
Troubleshooting
3630, page 1246

3631, page 1247
3640, page 1247
3641, page 1247
3642, page 1248
3643, page 1248
3645, page 1248
3647, page 1248
3648, page 1249
3650, page 1249
3651, page 1249
3652, page 1250
3654, page 1250
3655, page 1251
3656, page 1251
3657, page 1251
3658, page 1251
3659, page 1252
3660, page 1252
3661, page 1253
3662, page 1253
3663, page 1253
3664, page 1254
3665, page 1255
3680, page 1255
3681, page 1255
3682, page 1255
3686, page 1256
3687, page 1256
3688, page 1256
3689, page 1257
3690, page 1257
3691, page 1257
3694, page 1258
3695, page 1258
3696, page 1258
3800, page 1259

80000071-105 - 2018-09-10
Troubleshooting
Message code: 3002

Alkaline Wash level sensor failed.
failure.
Message code: 3003

Acid Wash level sensor failed.
failure.
Message code: 3004

Liquid too high for R1 pipettor at position (0).
0 = Position
The reagent probe is dirty. Perform Fluidics-Wash diagnostic procedure 4208 Probe
and Mixer Wash (c‑series), page 883.
3. Replace the pipettor cover. Ensure the cover is
seated firmly on the end of the pipettor above the
pipettor shaft.
The reagent probe is out of alignment. Perform Pipettors diagnostic procedure 4103 R1 Pipettor
Message code: 3005

Liquid too low for R1 pipettor at position (0).

80000071-105 - 2018-09-10
Troubleshooting
0 = Position
No reagent cartridge is present, or the reagent cartridge Load cartridges on the reagent and sample manager
is empty. (RSM), page 599.
pipettor shaft.
Message code: 3006

Liquid not found for R1 pipettor at position (0).
0 = Position
pipettor shaft.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 3007

Liquid too low for R2 pipettor at position (0).
0 = Position
pipettor shaft.
Message code: 3008

Liquid not found for R2 pipettor at position (0).
0 = Position
pipettor shaft.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 3009

Liquid too high for R2 pipettor at position (0).
0 = Position
pipettor shaft.
Message code: 3010

Unable to process test. Reagent cartridge empty or had LLS error.
The reagent cartridge is empty or has an LLS error. 1. Verify the reagent carousel inventory, page 622. If
necessary, replace the reagent cartridge.
2. Rerun the test.
Message code: 3011

Unable to process test. Liquid too high for R1 pipettor.

80000071-105 - 2018-09-10
Troubleshooting

pipettor shaft.
Message code: 3012

Unable to process test. Liquid contact broken during aspiration for R1 pipettor.
pipettor shaft.
Message code: 3013

Unable to process test. Liquid contact broken during aspiration for R2 pipettor.

80000071-105 - 2018-09-10
Troubleshooting

pipettor shaft.
Message code: 3014

ICT Reference Solution level sensor failed.
failure.
Message code: 3019

Unable to process test. Liquid not found for R1 pipettor.
pipettor shaft.

80000071-105 - 2018-09-10
Troubleshooting

specifications.
failure.
Message code: 3020

Unable to process test. Liquid not found for R2 pipettor.
pipettor shaft.
specifications.
failure.
Message code: 3021

Unable to process test. Liquid too high for R2 pipettor.

80000071-105 - 2018-09-10
Troubleshooting

pipettor shaft.
specifications.
failure.
Message code: 3022

Unable to process test due to previous aspiration error on sample.
A pressure monitor error was generated during the Review the specific message text. Perform the
aspiration of the sample for a previous test. corrective action for the specific message text.
Message code: 3023

Unable to process test. Liquid too high for sample pipettor at rack.
The sample cup or tube contains too much liquid. Load a sample cup or tube that contains the correct
amount of sample. See Sample volume requirements,
page 476.
The sample pipettor probe is dirty. Perform Fluidics-Wash diagnostic procedure 4208 Probe

80000071-105 - 2018-09-10
Troubleshooting

pipettor shaft.
The sample pipettor probe is out of alignment. Perform Pipettors diagnostic procedure 4102 Sample
Pipettor Calibration (c‑series), page 878.
The sample pipettor probe is damaged. Replace the sample probe (c‑series), page 922.
specifications.
failure.
Message code: 3033

LLS error occurred for (0) on module (1).
0 = Onboard solution
1 = Module
The sample onboard wash solutions level is low or Verify that adequate sample onboard wash solutions
empty. inventory is available and is not expired. Perform Verify
the supply and waste inventory, page 579.
The sample probe is damaged. Replace the sample probe (c‑series), page 922.
failure.
Message code: 3034

Liquid not found for (0) pipettor in (5) reagent carousel position (4).
0 = Pipettor
5 = Location
A reagent carousel inventory item is empty. Load a new reagent carousel inventory item.
The reagent probe is not straight. Perform Pipettors diagnostic procedure 1112 R1 Pipettor
Check and Calibration (i‑series), page 895 or 1113 R2

80000071-105 - 2018-09-10
Troubleshooting

The reagent probe is not positioned correctly. Perform Pipettors diagnostic procedure 1112 R1 Pipettor
The reagent probe is damaged. Replace the reagent probe. Perform Replace a sample
or reagent pipettor probe (i‑series), page 998.
failure.
Message code: 3035

Liquid not found at (0) pipettor in (5) reagent carousel position (3).
0 = Pipettor
3 = Location
No reagent cartridge is present or the reagent cartridge Load the reagent or replace the empty reagent
is empty. cartridge.
The reagent probe is dirty. Perform Weekly maintenance procedure 2620 Manual
Pipettor Probe Cleaning (i‑series), page 869.
failure.
Message code: 3036

0 = Pipettor
4 = Location

80000071-105 - 2018-09-10
Troubleshooting

failure.
Message code: 3037

0 = Pipettor
5 = Location
The probe traveled too far into the liquid after the initial Rerun the test. Perform Rerun a test or an exception for
fluid contact. a specimen or control, page 703.
Message code: 3038

Liquid too low at (0) pipettor in (5) reagent carousel position (4).
0 = Pipettor
5 = Location

80000071-105 - 2018-09-10
Troubleshooting

failure.
Message code: 3039

Unable to process test. Maximum number of LLS or PM errors exceeded for reagent cartridge.
LLS errors, PM errors, aspiration errors, or movement Review the system logs for messages that occurred at
restrictions are detected for the indicated pipettor. the same time as this message. Perform the corrective
action for the specific message text.
failure.
Message code: 3041

Liquid not found for (0) pipettor in (4).
0 = Pipettor
4 = Location
The sample probe is out of alignment. Perform the Probe Straightness option of Pipettors
The sample probe is damaged. Replace the sample probe. Perform Replace a sample or
failure.
Message code: 3042

0 = Pipettor
5 = Location

80000071-105 - 2018-09-10
Troubleshooting

A sample cup or tube is not present. Verify that a sample cup or tube is present.
The sample volume in the sample cup or tube is Place adequate sample in the cup or tube. See Sample
inadequate. volume requirements, page 476.
The sample probe is out of alignment. Perform the Calibration option of Pipettors diagnostic
procedure 1111 Sample Pipettor Check and Calibration
failure.
Message code: 3043

Liquid too low for (0) pipettor in (5).
0 = Pipettor
5 = Location
The sample probe is out of alignment. Perform Pipettors diagnostic procedure 1111 Sample
failure.
Message code: 3044

0 = Pipettor
5 = Location
The probe clamp is loose. Tighten probe clamp by hand.
The probe is out of alignment. Perform the Probe Straightness option of Pipettors
The probe is damaged. Replace the sample probe. Perform Replace a sample or

80000071-105 - 2018-09-10
Troubleshooting

failure.
Message code: 3045

Unable to process test. Liquid contact broken during aspiration for (0) pipettor in (5).
0 = Pipettor
5 = Location
The sample cup or tube is tilted in the rack. Reposition the sample cup or tube in the rack so that it
is not tilted.
A drop of liquid is present on the side of the sample cup Transfer the sample to a new sample cup or tube.
or tube.
A drop of liquid is present on the end of the probe. Tighten the probe tubing connections by hand.
failure.
Message code: 3046

0 = Pipettor
5 = Location
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 3047

0 = Pipettor
2 = Location
Bubbles, foam, or fibrin clots are present in the sample. Remove bubbles, foam, or fibrin clots by using a clean
disposable pipette or applicator stick.
or tube.
failure.
Message code: 3048

Maximum number of LLS errors exceeded in reagent cartridge (0) position located in reagent carousel
position (1).
0 = Bottle
Consecutive liquid level sense errors were detected for Additional messages that are associated with this
the indicated reagent cartridge. message can be used to determine the appropriate
Message code: 3049

Liquid too low for sample at (0).
0 = Pipetting location

80000071-105 - 2018-09-10
Troubleshooting

A sample cup or tube is not present. Verify that the sample cup or tube is present.
The sample volume in the sample cup or tube is Place adequate sample in the sample cup or tube.
inadequate.
A sample probe is out of alignment. Perform Pipettors diagnostic procedure 4102 Sample
A sample probe is damaged. Replace the sample probe (c‑series), page 922.
specifications. See Processing module water and liquid
waste specifications and requirements (c‑series), page
460.
• The liquid level sense board threshold voltage is failure.
out of range.
• The liquid level sense cable is defective.
Message code: 3050

Liquid not found for sample at (0).
A sample cup or tube is not present. Verify that the sample cup or tube is present.
The sample volume in the sample cup or tube is Place adequate sample in the sample cup or tube.
inadequate.

80000071-105 - 2018-09-10
Troubleshooting

460.
out of range.
• The liquid level sense board is defective.
• A connector on the SCM board is loose.
Message code: 3051

Liquid contact broken during aspiration for sample at (0).
The sample cup or tube is tilted in the rack. Reposition the sample cup or tube in the rack.
or tube.
The sample probe tubing connections are loose or Tighten the tubing connections or replace the tubing.
leaking.
The sample probe tubing is damaged. Replace the sample probe tubing (c‑series), page 930.
460.
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 3052

Liquid sensed too high for sample at (0).
Too much sample is present in the sample cup or tube. Place adequate sample in the sample cup or tube. See
the assay-specific sample volume requirements.
460.
out of range.
• The liquid level sense board is defective.
• A connector on the SCM board is loose.
Message code: 3058

Unable to process test. (0) is missing, empty or had LLS error.
0 = Onboard solution or sample onboard wash solution
An onboard solution cartridge is missing or is empty. Prepare and load a new onboard solution cartridge.
Perform Prepare onboard solutions (c‑series), page 625
(RSM), page 599.
An LLS error occurred for an onboard solution cartridge. Prepare and load a new onboard solution cartridge.
Perform Prepare onboard solutions (c‑series), page 625

80000071-105 - 2018-09-10
Troubleshooting

(RSM), page 599.
A sample onboard wash solution is missing or is empty. Replace sample onboard wash solutions and update the
inventory (c‑series), page 581.
An LLS error occurred for a sample onboard wash Replace sample onboard wash solutions and update the
solution. inventory (c‑series), page 581.
failure.
Message code: 3201

Degasser pressure high.
The incoming purified water pressure is high or has a Verify that the incoming purified water pressure is within
high gas content. specification.
failure.
Message code: 3202

Pressure monitoring error on (0) pipettor during wash.
0 = Pipettor
The pipettor is obstructed. Replace a sample or reagent pipettor probe (i‑series),
page 998.
failure.
Message code: 3203

Pressure monitoring error on (0) pipettor at location (5) carousel position (3).
0 = Pipettor
5 = Location

80000071-105 - 2018-09-10
Troubleshooting

The bulk solution level sensor connections are not 1. Verify that the bulk solution level sensor
connected correctly or are loose. connections are connected correctly and are
tightened.

failure.
Message code: 3213

(3) pipettor wash pressure error.
3 = Pipettor
Communication error. Cycle power to the processing module and the reagent
failure.
Message code: 3214

Pressure monitor communication error for (2) pipettor.
2 = Pipettor
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 3215

Pressure monitoring error for (0) pipettor in (5).
0 = Pipettor
1 = Location
The sample volume in the sample cup or tube is Place adequate sample in the sample cup or tube. See
inadequate. Sample volume requirements, page 476.
or tube.
failure.
Message code: 3302

Liquid too high in vacuum and waste accumulator.
failure.
Message code: 3303

Vacuum system failed. Vacuum sensor base too low.
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 3304

Vacuum system failed. Vacuum pressure too high.
failure.
Message code: 3305

Vacuum system failed. Vacuum pressure error.
failure.
Message code: 3306

Vacuum system failed. Liquid too high.
failure.
Message code: 3307

Vacuum system failed. Vacuum too low.
failure.
Message code: 3308

Vacuum (0) error.
0 = Error
Vacuum error. Additional messages that are associated with this

80000071-105 - 2018-09-10
Troubleshooting

Message code: 3309

Vacuum system pressure error.
Hardware failure. • Review the system log for errors that occurred at
the same time as this message. Perform corrective
actions for the specific message text.
failure.
Message code: 3310

Vacuum system failed. Waste pump pressure too low.
failure.
Message code: 3316

Vacuum initialization failed.
The vacuum system failed to initialize. Additional messages that are associated with this
Message code: 3317

Vacuum system failed. Waste pump error.

80000071-105 - 2018-09-10
Troubleshooting

failure.
Message code: 3319

Vacuum system detected low speed.
The vacuum system speed is low. Status message. No corrective action is required.
Message code: 3320

Vacuum system failed during initialization.
The vacuum system failed to initialize during startup or Cycle power to the processing module and the reagent
Run initialization. and sample manager (RSM), page 484.
Hardware failure. If the error continues, contact Customer Service. Provide
Message code: 3417

Pressure monitor board communications error. (0) (1) (2).
0 = Communication error
1 = Numeric code
2 = Dispense channel
failure.
Message code: 3418

(0) pipettor dispense error.

80000071-105 - 2018-09-10
Troubleshooting
0 = Pipettor
Pipettor error. Additional messages that are associated with this
Message code: 3420

Wash zone (0) aspiration error.
0 = Wash zone
Wash zone aspiration error. Additional messages that are associated with this
Message code: 3421

Wash zone (0) pump fill error.
0 = Wash zone
Wash zone pump fill error. Additional messages that are associated with this
Message code: 3422

Wash zone (0) dispense failed.
0 = Wash zone
Wash zone dispense error. Additional messages that are associated with this

80000071-105 - 2018-09-10
Troubleshooting
Message code: 3423

Cuvette washer water volume (0). Cuvette (1) volume (2).
0 = Volume
1 = Cuvette
2 = Volume
failure.
Message code: 3424

(0) pipettor aspiration error.
0 = Pipettor
Pipettor aspiration error. Additional messages that are associated with this
Message code: 3425

(0) pipettor sensor error.
0 = Pipettor
Pipettor sensor error. Additional messages that are associated with this
Message code: 3426

R1 aspiration error at position (0).
0 = Position

80000071-105 - 2018-09-10
Troubleshooting

The reagent probe tubing connections are loose or Replace the reagent probe tubing (c‑series), page 933.
leaking.
The tubing connection to the reagent syringe is loose. Tighten the tubing connections to the syringe body.
The reagent cartridge level is low or empty. Load cartridges on the reagent and sample manager
(RSM), page 599.
failure.
Message code: 3427

R2 aspiration error at position (0).
0 = Position
The reagent probe tubing connections are loose or Replace the reagent probe tubing (c‑series), page 933.
leaking.
The tubing connection to the reagent syringe is loose. Tighten the tubing connections to the syringe body.
(RSM), page 599.
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 3428

Unable to process test. R1 aspiration error.
(RSM), page 599.
failure.
Message code: 3429

Unable to process test. R2 aspiration error.
(RSM), page 599.
failure.
Message code: 3430

Unable to process test. Sample aspiration error.

80000071-105 - 2018-09-10
Troubleshooting

Bubbles, foam, or fibrin clots are present in the sample. • Remove bubbles or foam by using a clean
• Remove fibrin clots by using an applicator stick or
by recentrifuging the sample.
A drop of liquid is on the side of the sample cup or tube. Transfer the sample to a new sample cup or tube.
A drop of liquid is on the end of the probe. Tighten the tubing connection by hand.
failure.
Message code: 3431

Wash monitoring communication error on (2).
2 = Board
failure.
Message code: 3436

ICT reference aspiration check error (0).
0 = Error
A single flush did not remove all air from the ICT Perform ICT diagnostic procedure 5101 Flush ICT
Reference Solution tubing. Reference Solution Cup (c‑series), page 891.
page 952.

80000071-105 - 2018-09-10
Troubleshooting

The ICT probe is damaged. Replace the ICT probe. Perform Replace the ICT module
or the ICT probe (c‑series), page 952.
The ICT aspiration tubing is not connected correctly. Tighten the tubing connections at the top and at the side
of each check valve in the ICT Reference Solution
pump.
The ICT Reference Solution tubing is crimped or 1. Ensure that the ICT Reference Solution tubing is
damaged. not crimped or damaged.
2. Contact Customer Service to resolve any hardware
failure.
Reference Solution pump.
The ICT check valves are not functioning. Replace the check valves (c‑series), page 961.
The 1 mL syringes in the ICT Reference Solution pump Reseat the 1 mL syringes.
are not seated correctly.
The 1 mL syringes in the ICT Reference Solution pump Replace the 1 mL syringes (c‑series), page 958.
are leaking.
failure.
Message code: 3437

Unable to process test. Liquid contact broken during aspiration for sample pipettor at rack.
The sample cup or tube is not seated correctly in the Reseat the sample cup or tube in the rack.
rack.
A drop of liquid is on the side of the sample cup or tube. Transfer the sample to a new sample cup or tube.
The sample probe is dirty. Perform Fluidics-Wash diagnostic procedure 4208 Probe
pipettor shaft.

80000071-105 - 2018-09-10
Troubleshooting

The sample probe tubing connections are loose or • Tighten the tubing connections by hand.
leaking. • Replace the sample probe tubing (c‑series), page
930.
specifications.
failure.
Message code: 3446

Air during aspiration for (0) pipettor in (5) reagent carousel position (3).
0 = Pipettor
The reagent probe tubing connections are loose or • Tighten the reagent probe tubing connections by
leaking. hand.
• Replace a sample or reagent pipettor probe
Bubbles or foam is present on the surface of the • Allow the reagent cartridge to sit for the
reagent. recommended hold time to allow the bubbles or
foam to dissipate. For more information, see the
• Load a new reagent cartridge.
The reagent probe is out of alignment. 1. Perform Pipettors diagnostic procedure 1112 R1
2. Perform Pipettors diagnostic procedure 1113 R2
The reagent probe is damaged. Replace a sample or reagent pipettor probe (i‑series),
page 998.
(RSM), page 599.
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 3447

Air during aspiration for (0) pipettor in (5) reagent carousel position (3).
0 = Pipettor
The reagent probe tubing connections are loose or • Tighten the reagent probe tubing connections by
leaking. hand.
• Replace the reagent probe tubing (c‑series), page
933.
Bubbles or foam is present on the surface of the • Allow the reagent cartridge to sit for the
reagent. recommended hold time to allow the bubbles or
foam to dissipate. For more information, see the
• Load a new reagent cartridge.
The reagent probe is out of alignment. 1. Perform Pipettors diagnostic procedure 1112 R1
2. Perform Pipettors diagnostic procedure 1113 R2
The reagent probe is damaged. Replace a sample or reagent pipettor probe (i‑series),
page 998.
(RSM), page 599.
failure.
Message code: 3449

Unable to process test. Sample aspiration error.
Bubbles, foam, or fibrin clots are present in the sample. • Remove bubbles or foam by using a clean
• Remove fibrin clots by using an applicator stick or
by recentrifuging the sample.
The sample cup or tube is not seated correctly in the Ensure that the sample cup or tube is seated correctly
sample rack. in the sample rack.

80000071-105 - 2018-09-10
Troubleshooting

The sample probe is obstructed. Perform Replace a sample or reagent pipettor probe
The sample probe is damaged. Replace a sample or reagent pipettor probe (i‑series),
page 998.
The sample probe tubing failed. Contact Customer Service to resolve any hardware
failure.
Message code: 3450

(2) dispense monitoring error (0) (1).
0 = Board
1 = Error
2 = Mechanism
failure.
Message code: 3451

Wash monitoring failed to detect liquid at wash zone (0) position (1). Expected dispensed volume (3).
0 = Wash zone
1 = Position
3 = Expected dispense volume
No liquid is present in the reaction vessel at the wash • Repeat the sample that generated the error.
zone. • Perform Fluidics-Wash diagnostic procedure 1221
Wash Zone 1 Precision and Accuracy (i‑series),
page 906 or Fluidics-Wash diagnostic procedure
1222 Wash Zone 2 Precision and Accuracy
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 3452

Wash monitoring failed at wash zone (0) position (1). (3) volume dispensed. Expected volume range (4)
to (5).
0 = Wash zone
1 = Position
3 = Volume dispensed
4 = Expected range
5 = Expected range
The wash zone tubing connections are loose or leaking. Reconnect the wash zone tubing to the affected probe
for the indicated wash zone.
A wash zone probe is obstructed. Replace the wash zone probes (i‑series), page 1001.
The wash zone assembly is not seated correctly. 1. Loosen the knurled screws that secure the wash
zone assembly to the process path cover.
2. Reseat the wash zone assembly.
3. Tighten the knurled screws.
The knurled screws that secure the wash zone assembly 1. Tighten the four knurled screws that secure the
to the process path are loose. wash zone elevator assembly to the process path.
2. Tighten the two knurled screws that secure the
wash zone assembly to the wash zone elevator
assembly.
A wash zone probe is out of alignment. Remove the wash zone probe. Realign the wash zone
probe in the wash zone probe housing. Perform Replace
the wash zone probes (i‑series), page 1001.
The wash monitoring system is not calibrated. Perform the Calibration and Test option of Fluidics-
Wash diagnostic procedure 1261 Wash Zone 1 Wash
Monitoring (i‑series), page 908 or 1262 Wash Zone 2
Wash Monitoring (i‑series), page 908.
failure.
Message code: 3453

Wash monitoring failed at wash zone (0) position (1). LLS value (3) below expected value (4).
0 = Wash zone
1 = Position
3 = LLS valve
4 = Expected value

80000071-105 - 2018-09-10
Troubleshooting

The wash zone tubing connections are loose or leaking. Reconnect the wash zone tubing to the affected probe
for the indicated wash zone.
failure.
Message code: 3454

(0) pipettor trigger dispense error.
0 = Pipettor
The Trigger Solution dispense volume is inadequate. Additional messages that are associated with this
Message code: 3455

(0) dispense error.
0 = Mechanism
Dispense error. Additional messages that are associated with this
Message code: 3457

(0) pipettor trigger wash error.
0 = Pipettor
Pipettor trigger wash error. Additional messages that are associated with this

80000071-105 - 2018-09-10
Troubleshooting

Message code: 3458

Maximum number of consecutive wash monitoring errors at wash zone (0) exceeded.
0 = Wash zone
The tubing is connected incorrectly to the wash zone Reconnect the tubing to the affected probes for the
probes. indicated wash zone.
The wash zone assembly is not seated correctly. 1. Loosen the knurled screws that secure the wash
The knurled screws that secure the wash zone assembly 1. Tighten the four knurled screws that secure the
to the process path are loose. wash zone elevator assembly to the process path.
assembly.
A wash zone probe is out of alignment. Remove the wash zone probe. Realign the wash zone
probe in the wash zone probe housing. Perform Replace
the wash zone probes (i‑series), page 1001.
failure.
Message code: 3459

Unable to process test. Aspiration error for (0) pipettor in (5).
0 = Pipettor
5 = Location

80000071-105 - 2018-09-10
Troubleshooting

or tube.
failure.
Message code: 3460

Aspiration error for sample at (0).
The sample cup or tube is tilted in the rack. Reposition the sample cup or tube in the rack.
A sample probe is clogged or obstructed. Replace the sample probe (c‑series), page 922.
or tube.
A drop of liquid is present on the end of the probe. Tighten the sample tubing connection by hand.
• The pressure monitoring (PM) sensor is defective. failure.
• The PM sensor cable is disconnected.
• The PM board is defective.
Message code: 3462

Automatic probe wash failed for sample or R1 probe during aspiration.

80000071-105 - 2018-09-10
Troubleshooting

The onboard wash solutions are empty or insufficient. Verify that adequate onboard solutions are loaded.
Perform Verify the supply and waste inventory, page 579
and Verify the reagent carousel inventory, page 622.
failure.
Message code: 3463

Automatic probe wash failed for R2 probe during aspiration.
The onboard wash solutions are empty or insufficient. Verify that adequate onboard solutions are loaded.
Perform Verify the reagent carousel inventory, page 622.
failure.
Message code: 3471

Unable to process test. Aspiration error occurred previously for sample.
An aspiration error occurred during the aspiration from 1. Verify that the sample cup or tube contains an
the sample for a previous test. adequate volume of the sample. See Sample
volume requirements, page 476.
2. Remove bubbles, foam, or fibrin clots by using a
clean disposable pipette or applicator stick.
Message code: 3472

Pipettor (0) failed a trigger verification due to a PM error.
0 = Mechanism
A Trigger Solution dispense error occurred at the On the processing module, repeat Initiate or resume
reagent wash cup during the Run initialization. sample processing, page 648.
The reagent probe is leaking. • Tighten the probe fitting by hand.

80000071-105 - 2018-09-10
Troubleshooting

• Replace the reagent probe. Perform Replace a
998.
• The pressure monitor sensor is broken or failure.
disconnected.
• The probe tubing with the LLS cable failed.
• The Trigger dispense failed at the wash cup.
Message code: 3473

Pipettor (0) failed a trigger verification due to a trigger dispense error.
0 = Mechanism
A Trigger Solution dispense error occurred at the On the processing module, repeat Initiate or resume
reagent wash cup during the Run initialization. sample processing, page 648.
disconnected.
• The Trigger dispense failed at the wash cup.
Message code: 3474

Trigger verification error for (0).
0 = Mechanism
Trigger Solution dispense verification failed. Additional messages that are associated with this
Message code: 3475

Fluid was detected during an air aspiration of trigger solution during trigger solution verification.
The Trigger Solution tubing connections are loose or Tighten the Trigger Solution tubing connections.
leaking.

80000071-105 - 2018-09-10
Troubleshooting

The reagent probe is leaking. • Tighten the probe fitting by hand.
• Replace the reagent probe. Perform Replace a
998.
disconnected.
• The probe tubing with the LLS cable failed.
Message code: 3601

Low concentration waste tank full.
The drainage tubing or the overflow tubing is crimped. Reposition the drainage tubing or the overflow tubing so
that it is not crimped.
The waste tubing is too high. Adjust the waste tubing so it is less than 100 mm (4 in.)
from the ground.
failure.
Message code: 3603

(0) transfer error.
0 = Bulk solution
failure.
Software error. If the error continues, contact Customer Service. Provide
Message code: 3604

Diluted wash buffer transfer error.

80000071-105 - 2018-09-10
Troubleshooting

The diluted wash buffer level sensor is not connected Reseat the connection to the diluted wash buffer level
correctly. sensor.
The diluted wash buffer tubing is crimped. Reposition the diluted wash buffer tubing so that it is not
crimped.
The diluted wash buffer level sensor is damaged. Contact Customer Service to resolve any hardware
failure.
failure.
Message code: 3607

(0) failed.
0 = Sensor
failure.
Message code: 3608

Diluted wash buffer fill failed.
Diluted wash buffer fill failure. Additional messages that are associated with this
Message code: 3609

Wash buffer dilution assembly flush failed.
Wash buffer dilution assembly flush failure. Additional messages that are associated with this

80000071-105 - 2018-09-10
Troubleshooting
Message code: 3610

Wash buffer dilution assembly initialization failed.
Wash buffer dilution assembly initialization error. Additional messages that are associated with this
Message code: 3611

Conductivity error during (0). Conductivity (2) temperature (3).
0 = Fill or flush
2 = Conductivity
3 = Temperature
Bubbles are present in the wash buffer dilution Reinitialize the processing module. Perform Start the
assembly. processing module and the reagent and sample manager
(RSM), page 500.
The purified water quality is below specifications. Verify that the purified water purity is within
specifications.
The water temperature is too low. Verify that the water temperature is within specifications.
The water valve is turned off or damaged. Verify that the water valve is turned on and is not
damaged.
The water pressure is too low. Increase the incoming purified water pressure to be
within specifications. See Processing module water and
liquid waste specifications and requirements (i‑series),
page 460.
• The conductivity sensor failed. failure.
• The conductivity sensor board failed.
• The lower controller board failed.
Message code: 3612

Vacuum and waste accumulator sensor error.

80000071-105 - 2018-09-10
Troubleshooting

The vacuum accumulator is not seated correctly in the Verify that the vacuum accumulator is seated correctly
drawer. in the drawer.
Communication error. Cycle power to the system, page 480.
• The wasted accumulator sensor failed. failure.
• The sensor float failed.
• The sensor cable failed.
Message code: 3613

(0) pipettor flush error.
0 = Pipettor
Pipettor flush error. Additional messages that are associated with this
Message code: 3614

(0) wash error.
0 = Mechanism
Wash error. Additional messages that are associated with this
Message code: 3615

Wash zone (0) flush failed.
0 = Wash zone
Wash zone flush failure. Additional messages that are associated with this

80000071-105 - 2018-09-10
Troubleshooting

Message code: 3616

Waste pump error.
Waste pump error. Additional messages that are associated with this
Message code: 3617

Waste pump high pressure condition detected.
The waste line is obstructed. Verify that the waste line is not obstructed.
failure.
Message code: 3630

ICT reference filling check error. (0).
0 = Empty or failed
579.
pump.
ICT Reference Solution tubing is crimped or damaged. Ensure the ICT Reference Solution tubing is not crimped
or damaged.
Reference Solution pump.

80000071-105 - 2018-09-10
Troubleshooting

The 1 mL syringes in the ICT Reference Solution pump Reseat the 1 mL syringes.
are not seated correctly.
The 1 mL syringes in the ICT Reference Solution pump Replace the 1 mL syringes (c‑series), page 958.
are leaking.
failure.
Message code: 3631

Unexpected sensor status for internal water tank.
failure.
Message code: 3640

Flush failed.
Flush failure. Additional messages that are associated with this
Message code: 3641

(0) fluidics error.
0 = Mechanism
Fluidics error. Additional messages that are associated with this

80000071-105 - 2018-09-10
Troubleshooting
Message code: 3642

(0) flush error.
0 = Mechanism
Flush error. Additional messages that are associated with this
Message code: 3643

Waste pressure sensor error.
Water pressure sensor error. Additional messages that are associated with this
Message code: 3645

Conductivity sensor failed.
The conductivity sensor connection failed. Contact Customer Service to resolve any hardware
failure.
Message code: 3647

(0) transfer too slow.
0 = Bulk solution
The tubing connections are loose, leaking, or crimped. Tighten the tubing connections. Perform Replace the
level sensor for Pre-Trigger Solution, Trigger Solution, or
Concentrated Wash Buffer (i‑series), page 1010.
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 3648

(0) fluid transfer failed on module (1).
0 = Bulk solution
1 = Module
The bulk solution bottle is empty. Verify that the bulk solution bottle on the door is seated
correctly and has adequate fluid for a full transfer.
Perform Replace bulk solutions and update the inventory,
page 579.
The bulk solution bottle or cap is damaged. 1. Verify that the bulk solution bottle or cap is not
damaged.
2. Replace bulk solutions and update the inventory,
page 579.

failure.
Message code: 3650

(0) pipettor failed to aspirate wash buffer.
0 = Pipettor
A hardware error occurred. Additional messages that are associated with this
Message code: 3651

(0) reservoir filling process failed.
The fluid transfer failed. Verify that the bulk solution bottle on the door is seated
579.

80000071-105 - 2018-09-10
Troubleshooting

The level sensor connections are loose. Verify that the reservoir level sensor connections are
connected correctly.
The level sensor is damaged. • Replace the level sensor if it is cracked or leaking.
• Start the processing module and the reagent and
sample manager (RSM), page 500. Repeat the
transfer.
failure.
Message code: 3652

(0) reservoir partially filled.
The fluid transfer failed. Verify that the bulk solution bottle on the door is seated
579.
The level sensor connections are loose. Verify that the reservoir level sensor connections are
The level sensor is damaged. • Replace the level sensor if it is cracked or leaking.
• Start the processing module and the reagent and
sample manager (RSM), page 500. Repeat the
transfer.
failure.
Message code: 3654

Accumulator low sensor not detecting fluid.
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 3655

Vacuum and waste accumulator not draining in expected time.
failure.
Message code: 3656

Automatic probe wash failed for (1).
1 = Sample onboard wash solution
The sample probe wash failed. Verify that adequate sample onboard wash solutions
inventory is available and is not expired. Perform Verify
failure.
Message code: 3657

Sample probe wash dispense failed for (1).
1 = Sample onboard wash solution
The sample probe wash failed. Verify that adequate sample onboard wash solutions
inventory is available and is not expired. Perform Verify
The sample probe tubing is crimped or obstructed. Replace the sample probe tubing (c‑series), page 930.
failure.
Message code: 3658

Unexpected sensor status for internal water tank.

80000071-105 - 2018-09-10
Troubleshooting

failure.
Message code: 3659

Internal water tank filling error.
Maintenance is being performed on the purified water Do not operate the system while the purified water
system. system is undergoing cleaning or maintenance.
The water source supply was interrupted. Verify that the water source is functioning correctly.
Perform Fluidics-Wash diagnostic procedure 4205 Flush
Water Lines (c‑series), page 882.
The water source supply is restricted. Verify that the tubing from the water source is not
crimped or obstructed. Perform Fluidics-Wash diagnostic
procedure 4205 Flush Water Lines (c‑series), page 882.
The incoming purified water pressure is too low. Increase the incoming purified water pressure to be
liquid waste specifications and requirements (c‑series),
page 460.
Air bubbles are present in the water supply tubing. Verify the tubing connections. Perform Fluidics-Wash
diagnostic procedure 4205 Flush Water Lines (c‑series),
page 882.
• The supply water tubing is disconnected. failure.
• The incoming On/Off valve failed.
• The float sensor is disconnected or defective.
• The AC/DC driver board is defective.
• The AC/DC controller board is defective.
Message code: 3660

Transfer pump error detected on (2) pump (3).
2 = Board
3 = Pump
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 3661

Internal water tank is empty.
The water source supply was interrupted. Verify that the purified water system is functioning.
The water source supply is obstructed. Verify that the purified water system tubing is not
The incoming water pressure is too low. Increase the incoming water pressure to within be
specifications. See Processing module characteristics
The incoming water pressure is too high. Decrease the incoming water pressure to within be
Air bubbles are present in the water source supply. 1. Verify that the purified water system tubing
connections are functioning correctly.
failure.
Message code: 3662

Internal water tank overflow detected.
Hardware failure. Contact Customer Service to investigate and resolve the
hardware failures related to the incoming water on/off
valve and the internal water tank float sensor.
Message code: 3663

Internal water tank failed to fill.

80000071-105 - 2018-09-10
Troubleshooting

The water source supply is obstructed. Verify that the tubing from the purified water system is
not crimped or obstructed. Perform Fluidics-Wash
diagnostic procedure 4205 Flush Water Lines (c‑series),
page 882.
The incoming water pressure is too low. Increase the incoming water pressure to within
The incoming water pressure is too high. Decrease the incoming water pressure to within
failure.
Message code: 3664

Internal water tank failed to fill to the middle sensor.
The water source supply is obstructed. Verify that the purified water system tubing is not
The incoming water pressure is too low. Increase the incoming water pressure to within be
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 3665

Induction heating error on (2).
2 = Board
failure.
Message code: 3680

Diluted wash buffer level sensor error.
Diluted wash buffer level sensor error. Additional messages that are associated with this
Message code: 3681

Wash buffer dilution assembly failed to read the periodic conductivity.
• The conductivity sensor failed. failure.
Message code: 3682

Induction heating error for sample pipettor.
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 3686

Leak detected for Acid Wash reservoir. Current level sensor ADC (0), previous level sensor ADC (1) and
aspiration count (2).
0 = Current ADC level
1 = Previous ADC level
2 = Aspiration count
The bulk solution level sensor is damaged. Replace the bulk solution level sensor (c‑series), page
986.
The reservoir bottle is cracked. failure.
Message code: 3687

No aspiration detected for Acid Wash reservoir. Current level sensor ADC (0), previous level sensor ADC
(1) and aspiration count (2).
The level sensor tubing connections are loose or Tighten the tubing connections.
leaking.
The level sensor outlet tubing is pinched or crimped. Ensure that the outlet tubing is not pinched or crimped.
986.
The bulk solution valve assembly is broken. failure.
Message code: 3688

Leak detected for Alkaline Wash reservoir. Current level sensor ADC (0), previous level sensor ADC (1)
and aspiration count (2).
986.

80000071-105 - 2018-09-10
Troubleshooting

Message code: 3689

No aspiration detected for Alkaline Wash reservoir. Current level sensor ADC (0), previous level sensor
ADC (1) and aspiration count (2).
leaking.
986.
Message code: 3690

Leak detected for ICT Reference Solution reservoir. Current level sensor ADC (0), previous level sensor
ADC (1) and aspiration count (2).
986.
Message code: 3691

No aspiration detected for ICT Reference Solution reservoir. Current level sensor ADC (0), previous level
sensor ADC (1) and aspiration count (2).

80000071-105 - 2018-09-10
Troubleshooting

leaking.
986.
Message code: 3694

Induction heating detected a warning fault (0).
0 = Induction heating fault
A fault condition was detected during induction heating. Status message. No corrective action is required.
Message code: 3695

Waste pump connection error.
The waste pump connection check failed. failure.
Message code: 3696

The sample probe is not washed after aspirating a whole-blood or red blood cell sample.
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 3800

(0) Level sensor error.
0 = Bulk solution
Level sensor error. Additional messages that are associated with this
Optics and bar code reader message codes (4000-4999)

The optics and bar code reader message code category includes message codes from 4000
through 4999.
4000, page 1260
4011, page 1260
4012, page 1260
4013, page 1260
4014, page 1261
4015, page 1261
4016, page 1261
4017, page 1261
4018, page 1262
4019, page 1262
4021, page 1262
4023, page 1263
4301, page 1263
4309, page 1263
4310, page 1263
4311, page 1264
4312, page 1264
4313, page 1264
4314, page 1265
4315, page 1265
4335, page 1265

80000071-105 - 2018-09-10
Troubleshooting
4400, page 1266

4401, page 1266
4402, page 1267
4403, page 1267
4404, page 1267
4405, page 1267
4406, page 1268
4703, page 1268
4704, page 1269
Message code: 4000

Zero read detected.
failure.
Message code: 4011

Optics read error.
Optics read error. Additional messages that are associated with this
Message code: 4012

Optics initialization error.
Optics initialization error. Additional messages that are associated with this
Message code: 4013

Optics read data retrieval error.

80000071-105 - 2018-09-10
Troubleshooting

Optics read data retrieval error. Additional messages that are associated with this
Message code: 4014

Optics zero read error.
failure.
Message code: 4015

Background read error.
Background read error. Additional messages that are associated with this
Message code: 4016

Activated read error.
Activated read error. Additional messages that are associated with this
Message code: 4017

Optics error.

80000071-105 - 2018-09-10
Troubleshooting

Optics error. Additional messages that are associated with this
Message code: 4018

Optics communication error.
Optics communication error. Additional messages that are associated with this
Message code: 4019

Optics check failed during initialization.
The optics linearity or the normalization values are not Configure i‑series module settings, page 190.
entered correctly on the Module screen for the Alinity i
processing module.
The CMIA reader failed. Contact Customer Service to resolve any hardware
failure.
Message code: 4021

Shutter opened unexpectedly.
Shutter sensor failure. 1. Perform Optics diagnostic procedure 1005 Shutter
Test (i‑series), page 893.
2. Perform Cycle power to the processing module and

failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 4023

Unable to process test. Unexpected optical noise detected from the optics system.
An unexpected noise from the optics system was Rerun the sample.
detected.
Message code: 4301

RSM bar code reader communication error (0).
0 = Communication error
failure.
Message code: 4309

RSM error for rack at module (0) position (1).
0 = Module
1 = Position
The rack transfer failed at the load area. Reinsert the rack into the reagent and sample manager
or use a different rack.
failure.
Message code: 4310

Bar code read error for rack in RSM position (0).
0 = RSM position
The rack is missing a bar code or the bar code is Reinsert the rack into the reagent and sample manager
damaged. or use a different rack.

80000071-105 - 2018-09-10
Troubleshooting

The RSM bar code reader is dirty. Clean the RSM bar code reader. Perform As-Needed
maintenance procedure 2920 Manual RSM Transport
Cleaning, page 872.
failure.
Message code: 4311

Unable to read SID bar code in rack ID (0) position (1).
0 = Rack ID
1 = Position
The tube is not correctly positioned in the rack. Place the tube in the rack so that the bar code is visible
in the sample rack window and the bar code fills the
width of the window.
A bar code is damaged. Use a new bar code.
A bar code parameter configuration error occurred. Change sample bar code settings, page 200.
Cleaning, page 872.
The bar code reader failed. Contact Customer Service to resolve any hardware
failure.
Message code: 4312

Unable to read SID (0) bar code. Bar code contains invalid characters.
0 = SID
The SID contains an invalid character. Use valid characters only. Valid characters are defined
by Abbott Laboratories as A through Z, a through z, 0
through 9, and special characters.
Message code: 4313

Unable to process test. SID (0) does not match bar code (1) in rack ID (2) position (3).
0 = SID
1 = Bar code

80000071-105 - 2018-09-10
Troubleshooting
2 = Rack ID
3 = Position
The SID in the rack and position does not match the SID Load the tube with the correct SID in the rack and
in the order. position.
Message code: 4314

Unable to load reagent cartridge in RSM position (0). Bar code label cannot be read.
The reagent bottle bar code label is dirty. Clean the bar code label.
The reagent bottle bar code label is damaged. Load a new reagent cartridge. Perform Load cartridges
Cleaning, page 872.
failure.
Message code: 4315

Reagent cartridge scanned in RSM position (0) is already loaded on the reagent carousel at position (1).
0 = RSM position
A reagent cartridge with the same bar code is already Load a new reagent cartridge. Perform Load cartridges
loaded on the reagent carousel. on the reagent and sample manager (RSM), page 599.
failure.
Message code: 4335

Handheld bar code scanner status is (0).
0 = Hand-held bar code scanner status

80000071-105 - 2018-09-10
Troubleshooting

Hardware failure of the hand-held bar code scanner. 1. Verify that the hand-held bar code scanner cable is
plugged into the system control module computer.
failure.
Message code: 4400

Unable to process test. Lamp failed.
The lamp was not seated correctly when it was Repeat Replace the lamp or the lamp plate (c‑series),
replaced. page 937:
lamp plate and in the lamp housing.
screws to the lamp terminal block.
failure.
Message code: 4401

Optics system error. (0).
0 = Optics error
The lamp was not seated correctly when it was Repeat Replace the lamp or the lamp plate (c‑series),
replaced. page 937:
lamp plate and in the lamp housing.
screws to the lamp terminal block.
The water bath level is low. Perform Reaction Mechanisms diagnostic procedure
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 4402

Optics trigger sensor error.
failure.
Message code: 4403

Optics system warning. Fluctuation detected.
The lamp was not seated correctly when it was Repeat Quarterly maintenance procedure 5806 Change
replaced. Lamp (c‑series), page 862.
failure.
Message code: 4404

Optics system failed. Fluctuation above maximum range.
failure.
Message code: 4405

ADC over range at lamp check. (0).
0 = ADC error

80000071-105 - 2018-09-10
Troubleshooting

failure.
Message code: 4406

Optics system error. Lamp intensity too high.
failure.
Message code: 4703

Cuvette integrity check failed on cuvette (0).
0 = Cuvette number
The cuvettes are dirty. Clean the cuvettes. Perform Weekly Maintenance
procedure 5601 Clean Cuvettes with Detergent A
The cuvette is damaged. Replace the cuvette segment. Perform Replace the
cuvette segments (c‑series), page 941
The lamp was not seated correctly when it was Perform Quarterly maintenance procedure 5806 Change
replaced. Lamp (c‑series), page 862:
The water or wash solutions are not aspirated or Clean cuvette washer nozzles.
dispensed correctly into the reaction cuvettes.
of the pressure of the incoming water. within specifications. See Processing module water and
page 460.

80000071-105 - 2018-09-10
Troubleshooting

failure.
Message code: 4704

DAQ board failed.
failure.
Robotics and sensor message codes (5000-5999)

The robotics and sensor message code category includes message codes from 5000 through
5999.
5006, page 1275
5007, page 1275
5008, page 1275
5009, page 1276
5010, page 1276
5013, page 1276
5014, page 1277
5015, page 1277
5016, page 1277
5017, page 1277
5018, page 1278
5019, page 1278
5020, page 1278
5021, page 1278
5022, page 1279
5023, page 1279
5027, page 1279
5028, page 1280

80000071-105 - 2018-09-10
Troubleshooting
5110, page 1280

5111, page 1281
5112, page 1281
5113, page 1281
5114, page 1282
5115, page 1282
5116, page 1282
5117, page 1282
5119, page 1283
5125, page 1283
5126, page 1283
5127, page 1283
5128, page 1284
5129, page 1284
5130, page 1284
5131, page 1285
5132, page 1285
5133, page 1286
5210, page 1287
5211, page 1287
5212, page 1287
5213, page 1287
5214, page 1288
5215, page 1288
5216, page 1288
5217, page 1288
5218, page 1289
5219, page 1289
5220, page 1289
5221, page 1290
5222, page 1290
5223, page 1290
5224, page 1290
5225, page 1291
5228, page 1291
5229, page 1291
5230, page 1292
5231, page 1292
5232, page 1292

80000071-105 - 2018-09-10
Troubleshooting
5306, page 1292

5307, page 1293
5308, page 1293
5309, page 1293
5310, page 1294
5311, page 1294
5500, page 1294
5501, page 1294
5502, page 1295
5648, page 1295
5649, page 1295
5650, page 1296
5651, page 1297
5652, page 1297
5654, page 1297
5656, page 1297
5657, page 1298
5658, page 1299
5659, page 1299
5660, page 1299
5661, page 1299
5662, page 1300
5664, page 1300
5665, page 1300
5666, page 1301
5667, page 1301
5668, page 1301
5669, page 1301
5671, page 1302
5672, page 1302
5673, page 1302
5674, page 1302
5675, page 1303
5676, page 1304
5677, page 1305
5678, page 1305
5679, page 1305
5680, page 1306
5681, page 1306

80000071-105 - 2018-09-10
Troubleshooting
5682, page 1306

5683, page 1306
5684, page 1307
5685, page 1307
5686, page 1307
5687, page 1307
5688, page 1308
5689, page 1308
5690, page 1308
5691, page 1309
5692, page 1309
5693, page 1309
5694, page 1310
5695, page 1310
5696, page 1310
5697, page 1311
5698, page 1311
5722, page 1311
5723, page 1312
5724, page 1312
5725, page 1313
5726, page 1313
5727, page 1313
5728, page 1313
5729, page 1314
5731, page 1314
5732, page 1314
5733, page 1314
5734, page 1315
5735, page 1315
5736, page 1315
5744, page 1315
5745, page 1316
5747, page 1316
5748, page 1316
5749, page 1317
5750, page 1317
5751, page 1317
5752, page 1318

80000071-105 - 2018-09-10
Troubleshooting
5753, page 1318

5754, page 1318
5755, page 1318
5756, page 1319
5757, page 1319
5758, page 1319
5759, page 1319
5760, page 1320
5761, page 1320
5762, page 1320
5763, page 1321
5764, page 1321
5765, page 1321
5766, page 1321
5767, page 1322
5768, page 1322
5769, page 1322
5770, page 1322
5771, page 1323
5772, page 1323
5773, page 1323
5774, page 1324
5775, page 1324
5776, page 1324
5777, page 1324
5779, page 1325
5780, page 1325
5781, page 1325
5782, page 1325
5784, page 1326
5786, page 1326
5787, page 1326
5788, page 1326
5789, page 1327
5790, page 1327
5791, page 1327
5792, page 1328
5793, page 1328
5794, page 1329

80000071-105 - 2018-09-10
Troubleshooting
5795, page 1329

5796, page 1329
5797, page 1329
5798, page 1330
5799, page 1330
5800, page 1330
5801, page 1330
5802, page 1331
5803, page 1331
5804, page 1332
5805, page 1332
5806, page 1332
5807, page 1333
5809, page 1333
5810, page 1333
5811, page 1334
5812, page 1334
5813, page 1334
5814, page 1335
5815, page 1335
5816, page 1335
5817, page 1336
5818, page 1336
5819, page 1337
5820, page 1337
5821, page 1338
5822, page 1339
5823, page 1339
5824, page 1339
5825, page 1339
5826, page 1340
5827, page 1340
5828, page 1340
5829, page 1340
5830, page 1341
5831, page 1341
5832, page 1341
5833, page 1342
5859, page 1342

80000071-105 - 2018-09-10
Troubleshooting
5860, page 1343

5861, page 1343
5862, page 1343
5866, page 1344
5868, page 1344
5869, page 1345
5870, page 1345
Message code: 5006

RSM transport theta motor failed.
An error was detected with the RSM transport. Cycle power to the processing module and the reagent
failure.
Message code: 5007

(0) servo drive error (1).
0 = Motor
1 = Motor error
An error was detected with a servo drive motor. Cycle power to the processing module and the reagent
failure.
Message code: 5008

(0) motor communications error (1) (2).
0 = Motor
1 = Driver error
2 = Driver error number
An error occurred with motor communications. Additional messages that are associated with this

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5009

(0) servo drive error (1) (2).
0 = Motor
1 = Driver error
2 = Driver error number
An error was detected with the servo driver. Cycle power to the processing module and the reagent
failure.
Message code: 5010

Step loss detected on wash zone (0).
0 = Wash zone
A physical obstruction is blocking the movement of the Locate and remove any physical obstruction.
wash zone.
The wash zone probes are out of alignment. Remove the wash zone probes and realign the probes in
the wash zone probe housing. Perform Replace the
wash zone probes (i‑series), page 1001.
failure.
Message code: 5013

(0) motor error.
0 = Motor
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5014

(0) servo motor error.
0 = Motor
failure.
Message code: 5015

(0) concurrency error.
0 = Motor
An error was detected during motor movement. Cycle power to the processing module and the reagent
failure.
Message code: 5016

(0) error during homing.
0 = Motor
failure.
Message code: 5017

(0) time-out error.
0 = Motor
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5018

Number of specified pulses for (0) motor out of range.
0 = Motor
failure.
Message code: 5019

(0) sensor error.
0 = Sensor
failure.
Message code: 5020

(0) movement error.
0 = Motor
failure.
Message code: 5021

(0) drive starting status error.
0 = Motor

80000071-105 - 2018-09-10
Troubleshooting

failure.
Message code: 5022

(0) controller failed.
0 = Motor
failure.
Message code: 5023

(0) module initialization failed. Tray sensor error.
0 = Module number
The tray is not loaded correctly on the reagent and Unload and reload the tray on the RSM.
sample manager (RSM).
The bottom of tray is dirty. Clean the tray. Perform Clean and decontaminate
external components, page 873.
The tray is damaged. Use a different tray.
failure.
Message code: 5027

Unable to move rack in (0) for aspiration.
0 = Lane
A sample positioner movement error occurred. Additional messages that are associated with this

80000071-105 - 2018-09-10
Troubleshooting

Message code: 5028

The (0) sensor failed.
0 = RSM transport or latch
A physical obstruction is blocking the movement of the 1. Locate and remove any physical obstruction.
RSM transport or latch.
2. Perform Sample Manager diagnostic procedure
1610 Reagent and Sample Manager Test, page
917.

failure.
Message code: 5110

Water bath level low.
The system power is off. 1. Power on the processing module, page 489 or
Power on the reagent and sample manager (RSM),
page 497.
2. Fill the water bath. Perform Daily maintenance
procedure 5501 Daily Maintenance (c‑series), page
858 or Reaction Mechanisms diagnostic procedure
882.
The pressure of the incoming purified water is too low. Increase the incoming purified water pressure to be
page 460.
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5111

Cuvette washer upper limit not found.
A physical obstruction is blocking the movement of the Look for and remove any physical obstructions.
cuvette washer.
The black knob that holds the cuvette washer is loose. Tighten the black knob.
The dry tip of the cuvette washer is not aligned Align the cuvette dry tip. Perform Replace the cuvette
correctly. dry tip (c‑series), page 945.
failure.
Message code: 5112

Cuvette washer lower limit not found.
cuvette washer.
failure.
Message code: 5113

No RV detected in process path. Processing module status Stopped.
The reaction vessel was not detected on the process Contact Customer Service to resolve any hardware
path during initialization. failure.
The RV sensor is dirty or defective. Contact Customer Service to resolve any hardware
failure.
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5114

No reagent cartridge or rack detected at reagent carousel position (0).
failure.
Message code: 5115

(0) pick sensor failed.
0 = Sensor
failure.
Message code: 5116

No reagent cartridge or rack detected on module (0) position (1).
0 = Module
1 = Position
The rack or reagent cartridge was inserted incorrectly. Insert the rack or reagent cartridge correctly.
The rack or reagent cartridge is damaged. Replace the rack or reagent cartridge.
failure.
Message code: 5117

Reagent transport pick sensor failed.
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5119

(0) sensor failed.
0 = Sensor
failure.
Message code: 5125

Reagent transport sensor error.
The reagent transport sensor is dirty. Use a cotton swab and purified water to clean the
reagent transport sensors that are located on the
reagent transport picker head.
The reagent transport sensor failed. Contact Customer Service to resolve any hardware
failure.
Message code: 5126

Shutter sensor error. Shutter open sensor status (0) shutter close sensor status (1).
0 = Open sensor status
1 = Closed sensor status
Shutter sensor failure. Cycle power to the processing module and the reagent
failure.
Message code: 5127

Reagent transport cartridge present sensor error during initialization.

80000071-105 - 2018-09-10
Troubleshooting

failure.
Message code: 5128

(0) board (1) sensor failed.
0 = Board
1 = Sensor
failure.
Message code: 5129

Unable to load reagent cartridge or rack in reagent carousel. Reagent carousel sensor error at position
(0).
The RSM transport is unable to load the reagent Perform Reagent Manager diagnostic procedure 4703
cartridge after several attempts because of a sensor Reagent Supply Center Test (c‑series), page 887.
error.
failure.
Message code: 5130

Unable to load reagent cartridge or rack in reagent carousel position (0). Reagent transport pick sensor
error.
The RSM transport is unable to load the reagent Perform Reagent Manager diagnostic procedure 4703
cartridge after several attempts because of a sensor Reagent Supply Center Test (c‑series), page 887.
error.
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5131

Unable to load reagent cartridge or rack in reagent carousel. Latch sensor error at position (0).
The RSM transport is unable to load the reagent 1. Remove the reagent cartridge or onboard vial rack
cartridge or onboard vial rack after several attempts from the reagent carousel. Perform Manually
because of a sensor error. unload a cartridge or rack from the reagent
carousel, page 1449.
NOTE: The cartridge or rack must be loaded on the
system to reconcile the software inventory. If the
cartridge will not load on the system or is
unavailable to load on the system, contact
Customer Service to delete the cartridge.
2. Reinitialize the processing module and the reagent
and sample manager. Perform Start the processing
module and the reagent and sample manager
(RSM), page 500.
To test the functionality of the reagent supply center,

perform Reagent Manager diagnostic procedure 4703
A wedge latch is stuck or broken in the reagent failure.
carousel.
Message code: 5132

Unable to unload reagent cartridge or rack from reagent carousel position (0). Latch sensor error.
The RSM transport is unable to unload the reagent 1. Remove the reagent cartridge or onboard vial rack

80000071-105 - 2018-09-10
Troubleshooting

(RSM), page 500.

The reagent carousel and the reagent transport are out Perform Reagent Manager diagnostic procedure 4715
of alignment. Reagent Transport Calibration (c‑series), page 887.
A wedge latch is stuck or broken in the reagent failure.
carousel.
Message code: 5133

Unable to unload reagent cartridge or rack from reagent carousel position (0). Reagent transport pick
sensor error.
The RSM transport is unable to unload the reagent 1. Remove the reagent cartridge or onboard vial rack
(RSM), page 500.

• A wedge latch is stuck or broken in the reagent failure.
carousel.
• The reagent positioner is out of alignment.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5210

Memory check error on (0) board.
0 = Board
A communication failure with the CPU board has Cycle power to the processing module and the reagent
occurred. and sample manager (RSM), page 484.
failure.
Message code: 5211

(0) Ethernet error.
0 = Board
failure.
Message code: 5212

POST error on processing module. (0) (1).
0 = Board
1 = Board status
A communication failure with the PM board has Cycle power to the processing module and the reagent
failure.
Message code: 5213

Analog channel error on (2) (3).
2 = Sensor
3 = Board

80000071-105 - 2018-09-10
Troubleshooting

failure.
Message code: 5214

Wash buffer dilution assembly error on lower controller board.
failure.
Message code: 5215

Initialization error on (2) (3).
2 = Motor
3 = Board
failure.
Message code: 5216

Board configuration error on (2).
2 = Board
failure.
Message code: 5217

Power up error on (2).
2 = Board

80000071-105 - 2018-09-10
Troubleshooting

failure.
Message code: 5218

Vortexer error on (2) (3).
2 = Motor
3 = Board
failure.
Message code: 5219

Error on (2) LED (3).
2 = Board
3 = LED number
Hardware failure. • Cycle power to the processing module and the
failure.
Message code: 5220

LLS command error on (2).
2 = Board
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5221

Motor error on (2) (3).
2 = Motor
3 = Board
Communication error. • Cycle power to the system, page 480.
failure.
failure.
Message code: 5222

Status error on (2) (3).
2 = Motor
3 = Board
Communication error. • Cycle power to the system, page 480.
failure.
failure.
Message code: 5223

Optics command error temp-optics board.
Hardware failure. • Cycle power to the system, page 480.
failure.
Message code: 5224

Motor settings error on (2) (3).
2 = Motor
3 = Board

80000071-105 - 2018-09-10
Troubleshooting

Hardware failure. • Cycle power to the system, page 480.
failure.
Message code: 5225

Storage media error.
A communication failure with the CPU board has • Cycle power to the system, page 480.
occurred. • Contact Customer Service to resolve any hardware
failure.
failure.
Message code: 5228

(0) board firmware error (1) (2).
0 = Board
1 = Board Error
2 = Error
An error occurred with the firmware on the specified Additional messages that are associated with this
board. message can be used to determine the appropriate
Message code: 5229

Board communication error.
A communication error occurred with a board. Additional messages that are associated with this

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5230

Board failed during POST.
The initialization of the processing module failed. Cycle power to the processing module and the reagent
failure.
Message code: 5231

PHM error (0) (1) detected on control board.
0 = PHM error
1 = PHM error
A hardware error was detected on a control board. If the error continues, contact Customer Service. Provide
NOTE: Frequent occurrences of this message code may
indicate a pending hardware failure.
Message code: 5232

(0) offline.
0 = Board
The RSM load control board is Offline. Cycle power to the specified module. Perform Cycle
power to the processing module and the reagent and
failure.
Message code: 5306

(0) vortexer did not disengage from RV.
0 = Vortexer
failure.

80000071-105 - 2018-09-10
Troubleshooting

• The cable for the specified vortexer had a failed or
poor connection.
• The vortexer is not in the specified position.
Message code: 5307

(0) vortexer did not engage with RV.
0 = Vortexer
• The cable for the specified vortexer had a failed or failure.
poor connection.
Message code: 5308

(0) vortexer mixing error.
0 = Vortexer
Hardware failure. Additional messages can be associated with this
message to determine the appropriate corrective action.
View additional messages that are associated with a
message, page 1034.
Message code: 5309

(0) vortexer did not reach required speed.
0 = Vortexer
• The cable for the specified vortexer had a failed or failure.
poor connection.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5310

(0) vortexer initialization failed.
0 = Vortexer
The vortexer failed to initialize. Additional messages can be associated with this
message to determine the appropriate corrective action.
View additional messages that are associated with a
message, page 1034.
Message code: 5311

Maximum number of consecutive mixing errors exceeded for (0) vortexer.
0 = Vortexer
The vortexer failed. • Verify that the cable for the specified vortexer is
correctly connected.
• Perform Process Path diagnostic procedure 1510
Vortexer Test (i‑series), page 911.
failure.
Message code: 5500

(0) diverter failed.
0 = Diverter
failure.
Message code: 5501

(0) diverter error. Diverter did not return to rest position.
0 = Diverter
The diverter failed. Start the processing module and the reagent and sample
manager (RSM), page 500. Perform Process Path

80000071-105 - 2018-09-10
Troubleshooting

diagnostic procedure 1505 Diverter Test (i‑series), page
911.
failure.
Message code: 5502

(0) diverter error. Diverter did not move to active position.
0 = Diverter
The diverter failed. Start the processing module and the reagent and sample
manager (RSM), page 500. Perform Process Path
diagnostic procedure 1505 Diverter Test (i‑series), page
911.
failure.
Message code: 5648

Water bath drain error. (0).
0 = Drain error
The water bath drain tubing is crimped. Reposition the water bath drain tubing so that the tubing
is not crimped.
The external drain is obstructed. Remove the obstruction from the external drain.
failure.
Message code: 5649

Water bath fill time exceeded.
882.

80000071-105 - 2018-09-10
Troubleshooting

The water source supply is obstructed. 1. Verify that the tubing from the water source is not
crimped or obstructed.
882.
page 460.
Air bubbles are present in the water supply tubing. 1. Verify the tubing connections.

failure.
Message code: 5650

Water bath automatic fill failed.
882.
The water source supply is obstructed. 1. Verify that the tubing from the water source is not
crimped or obstructed.
882.
page 460.
Air bubbles are present in the water supply tubing. 1. Verify the tubing connections.

failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5651

Cuvette washer movement restricted at position (0) step number (1).
0 = Position
1 = Step number
cuvette washer.
failure.
Message code: 5652

Reagent carousel load failed. Latch error at position (0).
The reagent latch failed on the reagent carousel. Contact Customer Service to resolve any hardware
error.
failure.
Message code: 5654

Reagent carousel monitoring error.
An error occurred with the reagent carousel. Additional messages that are associated with this
Message code: 5656

Pick error at sample positioner (0) lane on module (1).
0 = Lane
1 = Module

80000071-105 - 2018-09-10
Troubleshooting

The RSM transport is unable to pick up the rack after 1. Remove the rack from the sample positioner.
several attempts.
2. Reinitialize the reagent and sample manager.
3. Perform Sample Manager diagnostic procedure
1600 RSM Transport Calibration, page 917.

failure.
Message code: 5657

Pick error at reagent positioner on module (0).
0 = Module
The reagent transport is unable to pick up the reagent 1. Remove the reagent cartridge or onboard vial rack
cartridge from the reagent positioner. from the reagent positioner.
2. Load the reagent cartridge or onboard vial rack on
the reagent and sample manager (RSM). Perform
Load cartridges on the reagent and sample
manager (RSM), page 599 or Load racks on the
3. Initiate sample processing for the RSM. Perform
Initiate or resume sample processing, page 648.
4. Reinitialize the processing module and the RSM.
The RSM transport is not calibrated. Perform Sample Manager diagnostic procedure 1600
The reagent positioner is out of alignment. failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5658

Pick error at loading area on module (0) position (1).
0 = Module
1 = Position
The rack or reagent cartridge was inserted incorrectly Insert the rack or reagent cartridge correctly.
The rack or reagent cartridge is damaged. Replace the rack or reagent cartridge.
The RSM transport is not calibrated. Perform Sample Manager diagnostic procedure 1600
failure.
Message code: 5659

Reagent positioner close failed.
The reagent positioner is jammed or obstructed. 1. Clear the jam or obstruction.

failure.
Message code: 5660

Reagent positioner move failed.
The reagent positioner is jammed or obstructed. Clear the jam or obstruction and reinitialize the reagent
and sample manager.
failure.
Message code: 5661

Reagent cartridge or rack no longer detected on reagent transport.

80000071-105 - 2018-09-10
Troubleshooting

The reagent transport sensor is dirty. Use a cotton swab and purified water to clean the
reagent transport sensors that are located on the
reagent transport picker head.
The reagent transport sensor failed. 1. Remove the rack or reagent cartridge from the
reagent transport.

failure.
Message code: 5662

Reagent transport failed to load reagent cartridge or rack in reagent carousel.
An error occurred with the reagent transport. Additional messages that are associated with this
Message code: 5664

Reagent transport failed to unload reagent cartridge or rack from reagent carousel.
An error occurred when a reagent cartridge or rack was Additional messages that are associated with this
unloaded. message can be used to determine the appropriate
Message code: 5665

Reagent carousel dispersion failed.
Initialization error. Start the processing module and the reagent and sample
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5666

RV loader linear queue error.
An error occurred with the RV loader linear queue. Additional messages that are associated with this
Message code: 5667

Pipettor Z motion error.
Hardware failure. • Reinitialize the processing module. Perform Start
failure.
Message code: 5668

(0) pipettor initialization error.
Pipettor initialization error. Additional messages that are associated with this
Message code: 5669

(0) pipettor monitoring error.
An error occurred with the pipettor. Additional messages that are associated with this

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5671

Process path initialization failed.
Process path initialization failed. Additional messages that are associated with this
Message code: 5672

Reagent supply center load error at processing module.
A reagent carousel load error occurred. Additional messages that are associated with this
Message code: 5673

Reagent supply center load error at RSM.
A load error occurred at the reagent and sample Additional messages that are associated with this
manager. message can be used to determine the appropriate
Message code: 5674

Reagent carousel operation failed.
An error occurred with the reagent carousel. Additional messages that are associated with this

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5675

Unable to pick up reagent cartridge or rack from (0).
0 = Location
The reagent transport is unable to load the reagent 1. Remove the reagent cartridge or onboard vial rack
cartridge or onboard vial rack in the reagent positioner. from the reagent positioner.

cartridge or onboard vial rack in the reagent carousel from the reagent carousel. Perform Manually
position. unload a cartridge or rack from the reagent
The reagent carousel and the reagent transport are not Perform Reagent Manager diagnostic procedure 1715
calibrated. Reagent Carousel and Reagent Transport Calibration
The reagent positioner is out of alignment. failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5676

Unable to load reagent cartridge or rack at (0).
0 = Location
cartridge or onboard vial rack in the reagent positioner. from the reagent transport.

Reagent Supply Center Test (i‑series), page 914.
cartridge or onboard vial rack in the reagent carousel. from the reagent carousel. Perform Manually
unload a cartridge or rack from the reagent
(RSM), page 500.


80000071-105 - 2018-09-10
Troubleshooting

failure.
Message code: 5677

Reagent supply center unload error at processing module.
unloaded from the reagent carousel. message can be used to determine the appropriate
Message code: 5678

Reagent supply center unload error at RSM.
unloaded from the reagent carousel. message can be used to determine the appropriate
Message code: 5679

RV detected in process path when attempting to load an RV.
The RV sensor is dirty or defective. Contact Customer Service to resolve any hardware
failure.
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5680

RV loader conveyor error.
An error occurred with the RV loader conveyor. Additional messages that are associated with this
Message code: 5681

RV loader initialization error.
RV loader initialization error. Additional messages that are associated with this
Message code: 5682

RV load error. RV detected on picker arm after load attempted.
A reaction vessel (RV) was detected on the RV pick and • Remove the RV from the RV pick and place
place assembly after an attempt to load the RV in the assembly.
process path. • Start the processing module and the reagent and
failure.
Message code: 5683

RV pick and place movement error.
RV pick and place movement error. Additional messages that are associated with this

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5684

RSM transport pick error at sample positioner.
An RSM transport pick error occurred at the sample Additional messages that are associated with this
positioner. message can be used to determine the appropriate
Message code: 5685

RSM transport place error at sample positioner.
An RSM transport place error occurred at the sample Additional messages that are associated with this
positioner. message can be used to determine the appropriate
Message code: 5686

Rack or reagent cartridge load error on RSM.
A load error occurred on the reagent and sample Additional messages that are associated with this
manager. message can be used to determine the appropriate
Message code: 5687

Rack or reagent cartridge load error on reagent positioner.
A load error occurred at the reagent positioner. Additional messages that are associated with this

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5688

RV waste error.
RV waste error. Additional messages that are associated with this
Message code: 5689

Sample pipettor movement restricted.
The stopper is not removed from the sample tube. Remove the stopper from the sample tube.
The sample cup or tube was not correctly placed in the Ensure the sample cup or tube is fully seated into the
rack. sample rack and is positioned straight.
sample pipettor.
failure.
Message code: 5690

Sample pipettor movement restricted at rack.
sample pipettor.

80000071-105 - 2018-09-10
Troubleshooting

failure.
Message code: 5691

Unable to process test. Water bath level low.
A water bath level or temperature error occurred while • Review the specific message text. Perform the
the system was processing the test. corrective action for the specific message text.
• Rerun the test. Perform Rerun a test or an
Message code: 5692

R1 pipettor upper limit not found at position (1).
1 = Position
A communication failure with the SMC board has Cycle power to the processing module and the reagent
failure.
Message code: 5693

R2 pipettor upper limit not found at position (1).
1 = Position
A communication failure with the SMC board has Cycle power to the processing module and the reagent
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5694

Reagent carousel inventory check error.
failure.
Message code: 5695

Unable to process test. R1 pipettor movement restricted.
The reagent cartridge is empty. Load a new reagent.
R1 reagent pipettor.
The R1 reagent pipettor probe is out of alignment. Perform Pipettors diagnostic procedure 4103 R1 Pipettor
The R1 reagent pipettor probe is damaged. Replace the reagent probes (c‑series), page 925.
failure.
Message code: 5696

Unable to process test. R2 pipettor movement restricted.
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5697

Sample pipettor movement restricted at rack.
sample pipettor.
failure.
Message code: 5698

Unable to process test. Sample pipettor vertical homing failed.
A physical interference is blocking the movement of the 1. Locate and remove any physical obstruction.
sample pipettor.

failure.
Message code: 5722

Reagent cartridge or rack not found at reagent carousel position (1).
1 = Position
The reagent cartridge or onboard vial rack is damaged. 1. If the reagent cartridge or onboard vial rack is still
in the reagent carousel position and is not
detected, perform Manually unload a cartridge or
rack from the reagent carousel, page 1449.

80000071-105 - 2018-09-10
Troubleshooting

(RSM), page 500.
If the cartridge or rack is damaged, load a different or

new cartridge or rack. Perform Load cartridges on the
reagent and sample manager (RSM), page 599 or Load
racks on the reagent and sample manager (RSM), page
595.
failure.
Message code: 5723

Reagent cartridge or rack at reagent carousel position (1) no longer detected by reagent transport.
1 = Position
The RSM transport arm is dirty. Clean the RSM transport arm.
RSM transport sensor failure. Clean the RSM transport sensor.
Reagent carousel reagent pack detector failure. Contact Customer Service to resolve any hardware
failure.
failure.
Message code: 5724

Mixer 1 high frequency vibration error.

80000071-105 - 2018-09-10
Troubleshooting

Mixer 1 is damaged. Replace the mixers (c‑series), page 948.
failure.
Message code: 5725

Mixer 1 low frequency vibration error.
failure.
Message code: 5726

Mixer 1 vibration error.
failure.
Message code: 5727

Mixer 2 high frequency vibration error.
failure.
Message code: 5728

Mixer 2 low frequency vibration error.

80000071-105 - 2018-09-10
Troubleshooting

failure.
Message code: 5729

Mixer 2 vibration error.
failure.
Message code: 5731

ICT unit lower limit not found at ICT Reference Solution cup.
failure.
Message code: 5732

ICT unit obstacle detected at ICT Reference Solution cup.
ICT unit.
failure.
Message code: 5733

ICT unit upper limit not found at ICT Reference Solution cup.
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5734

ICT unit lower limit not found at cuvette.
failure.
Message code: 5735

ICT unit obstacle detected at cuvette.
ICT unit.
failure.
Message code: 5736

ICT unit upper limit not found at cuvette.
failure.
Message code: 5744

R1 pipettor movement restricted at (0) position (1).
0 = Location
1 = Position

80000071-105 - 2018-09-10
Troubleshooting

failure.
Message code: 5745

R2 pipettor movement restricted at (0) position (1).
0 = Location
1 = Position
failure.
Message code: 5747

Unload to (0) reagent cartridge at position (1) within specified time.
0 = Reagent cartridge
1 = Position
The reagent cartridge is damaged. Replace the reagent cartridge.
The reagent cartridge was not loaded or unloaded Perform Sample Manager diagnostic procedure 1600
during the specific time. RSM Transport Calibration, page 917.
failure.
Message code: 5748

Reagent transport (0) error at reagent carousel position (1).
0 = Error
1 = Position

80000071-105 - 2018-09-10
Troubleshooting

failure.
Message code: 5749

Shutter move error.
An error occurred with the shutter. Additional messages that are associated with this
Message code: 5750

Reagent carousel or dispersion motor homing failed.
The reagent carousel or the dispersion motor failed to Cycle power to the processing module and the reagent
move to the home position. and sample manager (RSM), page 484.
failure.
Message code: 5751

(2) board (3) (0) (1) error.
0 = Error
1 = Error
2 = Board
3 = Board DIO
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5752

Process path move error on (0) lane.
0 = Process path lane
The process path move failed. • Initiate or resume sample processing.
• Cycle power to the processing module and the
failure.
Message code: 5753

Reagent transport failed.
The reagent cartridge is damaged. Replace the reagent cartridge.
The RSM transport arm sensor is dirty. Perform As-Needed maintenance procedure 2920
Manual RSM Transport Cleaning, page 872.
failure.
Message code: 5754

RSM transport initialization error.
RSM transport initialization error. Additional messages that are associated with this
Message code: 5755

RV linear queue empty.

80000071-105 - 2018-09-10
Troubleshooting

The RV hopper is empty. Replenish reaction vessels (RVs) and update the
Message code: 5756

Process path jam recovery on (0) successful.
RV jam recovery was performed successfully. Status message. No corrective action is required.
Message code: 5757

Process path jam recoveries on (0) excessive.
RV jam recoveries in the process path have exceeded Contact Customer Service to resolve any hardware
the allowable limit. failure.
Message code: 5758

Process path jam recovery successful on (0). Process path may require servicing.
An RV was jammed in the process path. A recovery was performed to clear the RV jam.
NOTE: Frequent occurrences of this message code may
indicate a pending hardware failure.

failure.
Message code: 5759

(2) (3) solenoid error.
2 = Board
3 = Solenoid

80000071-105 - 2018-09-10
Troubleshooting

failure.
Message code: 5760

Servo module error (0) (1).
0 = Error
1 = Error
failure.
Message code: 5761

Prime error.
An error occurred during a prime of the Pre-Trigger and Initiate or resume sample processing.
Trigger manifold.
failure.
Message code: 5762

Wash zone (0) initialization failed.
0 = Wash zone
Wash zone initialization error. Additional messages that are associated with this

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5763

(0) pipettor homing failed.
0 = Pipettor
A homing error occurred on the specified pipettor. Additional messages that are associated with this
Message code: 5764

RSM transport homing error.
RSM transport homing error. Additional messages that are associated with this
Message code: 5765

RSM transport Z error.
RSM transport Z error. Additional messages that are associated with this
Message code: 5766

RSM transport X error.
RSM transport X error. Additional messages that are associated with this

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5767

RSM transport theta error.
Message code: 5768

RV load failed.
A hardware error occurred and the RV loader failed. Additional messages that are associated with this
Message code: 5769

Step loss detected on (0).
0 = Motor
Motor homing failure. Cycle power to the processing module and the reagent
failure.
Message code: 5770

Step loss detected on (0).
0 = Motor
component.

80000071-105 - 2018-09-10
Troubleshooting


failure.
Message code: 5771

(0) pipettor move error.
0 = Pipettor
Pipettor move error. Additional messages that are associated with this
Message code: 5772

Loading area pick error.
Loading area pick error. Additional messages that are associated with this
Message code: 5773

Reagent positioner pick error.
Reagent positioner pick error. Additional messages that are associated with this

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5774

RV loader orienter correction attempts excessive.
failure.
Message code: 5775

Sample positioner initialization error.
Sample positioner initialization failed. Additional messages that are associated with this
Message code: 5776

RSM transport pick error.
An RSM transport pick error occurred. Additional messages that are associated with this
Message code: 5777

RSM transport pick sensor error.
An RSM transport pick sensor error occurred. Additional messages that are associated with this

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5779

Reagent supply center initialization failed.
failure.
Message code: 5780

Priority button error.
A priority button error occurred. Additional messages that are associated with this
Message code: 5781

Loading area position error.
A position error occurred on the loading area. Additional messages that are associated with this
Message code: 5782

Loading area tray error.
An error occurred when a tray was loaded on the Additional messages that are associated with this
reagent and sample manager. message can be used to determine the appropriate

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5784

Shutter error.
A shutter error has occurred. Additional messages that are associated with this
Message code: 5786

Sample positioner initialization error.
Sample positioner initialization failed. Additional messages that are associated with this
Message code: 5787

RSM transport error from module (0) position (1) to module (2) position (3).
0 = Module
1 = Position
2 = Module
3 = Position
An RSM transport error has occurred. Additional messages that are associated with this
Message code: 5788

RSM transport error moving to park position.
A physical interference is blocking the RSM transport 1. Locate and remove any physical obstruction.
movement to the park position.

80000071-105 - 2018-09-10
Troubleshooting


failure.
Message code: 5789

Unable to process sample. RSM rack transport error.
An error occurred with the RSM transport when a rack Rerun the tests. Perform Rerun a test or an exception for
failure.
Message code: 5790

Pick error at loading area on module (0) position (1).
0 = Module
1 = RSM position
The rack or reagent cartridge was inserted incorrectly. Insert the rack or reagent cartridge correctly.
The rack or reagent cartridge is damaged. Load a new rack or reagent cartridge.
The RSM transport arm is dirty. Perform As-Needed maintenance procedure 2920
Manual RSM Transport Cleaning, page 872.
The reagent and sample manager is out of alignment. Perform Sample Manager diagnostic procedure 1600
failure.
Message code: 5791

Place error at loading area on module (0) position (1).

80000071-105 - 2018-09-10
Troubleshooting
0 = Module
1 = RSM position
failure.
Message code: 5792

Unable to process test. Step loss detected for (0) pipettor at reagent carousel.
0 = Pipettor
pipettor.
reagent and sample manager (RSM), page 500 for
the appropriate module.

failure.
Message code: 5793

Rack prematurely removed from RSM transport arm.
A physical obstruction caused a rack transport failure. 1. Locate and remove any physical obstruction.
reagent and sample manager (RSM), page 500 for
the appropriate module.

failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5794

Reagent carousel load error.
A hardware error occurred. An item was unable to load Additional messages that are associated with this
in the reagent carousel. message can be used to determine the appropriate
Message code: 5795

Reagent carousel unload error.
A hardware error occurred. An item was unable to Additional messages that are associated with this
unload from the reagent carousel. message can be used to determine the appropriate
Message code: 5796

Reagent positioner movement failed.
The reagent positioner cannot open or close. Start the processing module and the reagent and sample
manager (RSM), page 500. Perform Sample Manager
diagnostic procedure 1610 Reagent and Sample
Manager Test, page 917.
failure.
Message code: 5797

(0) sample positioner movement error.
0 = Sample positioner
A sample positioner movement error occurred. Additional messages that are associated with this

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5798

(0) sample positioner latch movement error.
A sample positioner latch movement error occurred. Additional messages that are associated with this
Message code: 5799

(0) sample positioner homing error.
A sample positioner homing error occurred. Additional messages that are associated with this
Message code: 5800

(0) sample positioner initialization error.
A sample positioner initialization error occurred. Additional messages that are associated with this
Message code: 5801

(0) sample positioner failed to latch rack in sample positioner pocket.

80000071-105 - 2018-09-10
Troubleshooting

The rack failed to latch in the sample positioner. 1. Remove the rack from the sample positioner.
The rack is damaged. Use a different rack.

The reagent and sampler manager is out of alignment. Perform Sample Manager diagnostic procedure 1600
failure.
Message code: 5802

Processing module initialization failed. RV load check error.
RVs are blocking the access path to the RV orienter 1. Open the RV access door and stir the RVs in the
wheel. RV hopper by hand.
2. If the RVs are not picked up, wait until all tests in
process are completed.
3. Remove all the RVs from the RV hopper when the
instrument status of the processing module is Idle.
4. Inspect the path to the RV loader wheel and
remove any RVs.
The RV pickers on the RV orienter wheel are broken. Contact Customer Service to resolve any hardware
failure.
An RV is jammed in the linear queue. 1. If accessible, clear the RV jam in the linear queue.
An RV pick and place assembly error occurred. Contact Customer Service to resolve any hardware
failure.
failure.
Message code: 5803

RV load error. RV dropped from picker arm.

80000071-105 - 2018-09-10
Troubleshooting

No RV is detected on the picker arm. If the error occurs infrequently, no corrective action is
required.
Perform Process Path diagnostic procedure 1520 RV
Load and Unload Test (i‑series), page 912.
failure.
Message code: 5804

RV picker arm step loss error.
RV picker arm.

failure.
Message code: 5805

RV load error. No RV detected in linear queue after attempting to pick an RV.
RV sensor failure. Start the processing module and the reagent and sample
manager (RSM), page 500. If the error continues,
perform RV Loader diagnostic procedure 1400 RV
Loader and Sensors Test (i‑series), page 910.
failure.
Message code: 5806

RV load error. RV left in linear queue.
The RV loaded incorrectly. Start the processing module and the reagent and sample
manager (RSM), page 500. If the error continues,
perform RV Loader diagnostic procedure 1400 RV

80000071-105 - 2018-09-10
Troubleshooting

failure.
Message code: 5807

RVs have not been picked up by RV orienter for an extended period of time.
RVs are blocking the access path to the RV orienter. 1. If the RVs are not picked when all tests in process
are completed, pause the processing module.
2. Perform Process Path diagnostic procedure 1520
RV Load and Unload Test (i‑series), page 912.
3. Perform the Conveyor Motor option of the RV
Loader diagnostic procedure 1400 RV Loader and
Sensors Test (i‑series), page 910.

failure.
Message code: 5809

Unable to process test. Pretreatment path disabled.
The pretreatment path is disabled. • Start the processing module and the reagent and
• Additional messages that are associated with this
failure.
Message code: 5810

Unable to process test. Wash zone 1 disabled.
A wash zone 1 error occurred. Additional messages that are associated with this

80000071-105 - 2018-09-10
Troubleshooting

Message code: 5811

RSM transport home flag not found.
RSM transport.
The RSM transport cable has a poor connection. Contact Customer Service to resolve any hardware
failure.
failure.
Message code: 5812

Unable to transfer onboard vial rack (0) on module (1) reagent carousel position (2).
0 = Rack ID
1 = Module
The onboard vial rack was unable to transfer to or from Additional messages that are associated with this
the reagent carousel. message can be used to determine the appropriate
Message code: 5813

Unable to turn on (0).
0 = Device
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5814

Unable to turn off (0).
0 = Device
failure.
Message code: 5815

(0) sample positioner move request failed during calibration.
sample positioner.
3. If the error continues, perform Sample Manager
diagnostic procedure 1600 RSM Transport
Calibration, page 917.

failure.
Message code: 5816

Sample positioner move request failed during pipettor calibration.
The reagent and sample manager is obstructed. 1. Locate and remove any physical obstruction.
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5817

Unable to initialize module due to previous load or unload error. Remove reagent cartridge or rack with
load or unload error from reagent carousel.
The reagent transport is unable to load or unload the 1. Remove the reagent cartridge or onboard vial rack
reagent cartridge or onboard vial rack from the reagent from the reagent carousel. Perform Manually
carousel. unload a cartridge or rack from the reagent
(RSM), page 500 for the appropriate module.

The reagent cartridge or onboard vial rack is damaged. Load a different or new reagent cartridge or onboard
vial rack. Perform Load cartridges on the reagent and
sample manager (RSM), page 599 or Load racks on the
The reagent transport cable or sensor connections are failure.
loose.
Message code: 5818

Reagent transport error.
An error occurred when the reagent transport moved. Reinitialize the reagent and sample manager. Perform
Start the processing module and the reagent and sample
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5819

Reagent cartridge load error at reagent carousel position (0).
The reagent cartridge or onboard vial rack is damaged. 1. Remove the reagent cartridge or onboard vial rack
from the reagent carousel. Perform Manually

595.
• A physical obstruction is blocking the movement of failure.
the reagent transport.
• The reagent transport connections are loose or not
seated correctly.
• One or more reagent carousel positions are
damaged.
Message code: 5820

Reagent cartridge unload error at reagent carousel position (0).
The reagent cartridge or onboard vial rack is damaged. 1. Remove the reagent cartridge or onboard vial rack
from the reagent carousel. Perform Manually

80000071-105 - 2018-09-10
Troubleshooting


595.
A physical interference is blocking the unloading of the Locate and remove any physical obstruction.
reagent cartridge or onboard vial rack.
• A physical obstruction is blocking the movement of failure.
the reagent transport.
• The reagent transport connections are loose or not
seated correctly.
• One or more reagent carousel positions are
damaged.
• The reagent transport motors or belts are damaged.
Message code: 5821

Power supply error on voltage (1).
1 = Voltage
The power supply voltage failed. Contact Customer Service to resolve any hardware
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5822

Sample pipettor upper limit not found.
The sample pipettor was physically pushed down from 1. Transition the processing module to a status of
its vertical home position. Stopped.
sample pipettor.

failure.
Message code: 5823

Mixer 1 lower limit not found.
failure.
Message code: 5824

Mixer 1 upper limit not found.
failure.
Message code: 5825

Mixer 2 lower limit not found.

80000071-105 - 2018-09-10
Troubleshooting

failure.
Message code: 5826

Mixer 2 upper limit not found.
failure.
Message code: 5827

Unable to initialize process path. Hardware error.
The process path failed to initialize. Additional messages that are associated with this
Message code: 5828

Module initialization failed. Hardware error.
The module failed to initialize. Additional messages that are associated with this
Message code: 5829

Processing center cover error.

80000071-105 - 2018-09-10
Troubleshooting

A processing center cover sensor error occurred. Additional messages that are associated with this
Message code: 5830

RSM transport safety LED has a defect.
One of the RSM transport safety LEDs is defective. Status message. No corrective action is required.
NOTE: The RSM transport safety LED needs to be
replaced by an Abbott Laboratories representative during
the next time that servicing is performed on the system.
Message code: 5831

Both RSM transport safety LEDs have a defect.
Both of the RSM transport safety LEDs are defective. Contact Customer Service to replace the RSM transport
safety LEDs. The LEDs must be replaced by an Abbott
Message code: 5832

Unable to unload reagent cartridge or rack from reagent carousel position (0). Reagent cartridge or rack
in reagent positioner.
A reagent cartridge or an onboard vial rack is already 1. Remove the reagent cartridge or onboard vial rack
loaded in the reagent positioner. from the reagent positioner.

80000071-105 - 2018-09-10
Troubleshooting


• The reagent transport cable or sensor connections failure.
are loose.
• The reagent positioner is out of alignment.
Message code: 5833

Unable to load reagent cartridge in RSM position (0).
0 = RSM position
No processing module is available to load the reagent 1. Verify that a processing module is available with
cartridge. the required assay enabled.
2. Reload the reagent cartridge on the reagent and
sample manager.
Message code: 5859

RV load error. No RV detected in the process path.
Process path initialization failed. Additional messages that are associated with this

80000071-105 - 2018-09-10
Troubleshooting
Message code: 5860

Sample positioner (0) lane failed.
0 = Lane
An error occurred at the sample positioner. Additional messages that are associated with this
Message code: 5861

RV loader orienter error.
An error occurred on the RV orienter. Additional messages that are associated with this
Message code: 5862

RV orienter error. RV not loading in linear queue.
The RV hopper is empty. Replenish reaction vessels (RVs) and update the
An RV did not drop from the RV picker arm into the 1. Remove the RV from the RV orienter.
linear queue.
3. Perform RV Loader diagnostic procedure 1400 RV
An RV fell off the RV orienter before the RV reached the If this problem occurs infrequently (three times a day or
linear queue. fewer), no corrective action is required.
An RV is jammed in the RV waste chute. 1. Remove the RV waste chute cover and then
remove the RV.

80000071-105 - 2018-09-10
Troubleshooting

2. Replace the RV waste chute cover.
The RV pickers on the RV orienter wheel are broken. Contact Customer Service to resolve any hardware
failure.
An RV orienter sensor failure occurred. Contact Customer Service to resolve any hardware
failure.
failure.
Message code: 5866

(0) is not connected.
0 = Solenoid name
failure.
Message code: 5868

Remove rack or reagent cartridge from RSM transport at reagent positioner, module (0) prior to
initialization.
0 = Module
A reagent cartridge or an onboard vial rack remains on 1. Remove the reagent cartridge or onboard vial rack
the reagent positioner. from the reagent positioner.
2. To transition the instrument status of the reagent
and sample manager (RSM) to Running, perform
the RSM. Perform Load cartridges on the reagent
and sample manager (RSM), page 599 or Load
page 595.

80000071-105 - 2018-09-10
Troubleshooting


failure.
Message code: 5869

Remove rack or reagent cartridge from RSM transport at module (0) position (1) prior to initialization.
0 = Module
1 = Position
A reagent cartridge or an onboard vial rack remains on 1. Remove the reagent cartridge or onboard vial rack
the RSM transport. from the RSM transport.
2. To transition the instrument status of the reagent
and sample manager (RSM) to Running, perform
the RSM. Perform Load cartridges on the reagent
and sample manager (RSM), page 599 or Load
page 595.

failure.
Message code: 5870

Unable to process test. R2 pipettor is disabled.

80000071-105 - 2018-09-10
Troubleshooting

The R2 pipettor is disabled. 1. Review the system logs for messages that occurred
at the same time as this message. Perform the

failure.
Support system message codes (6000-6999)

The support system message code category includes message codes from 6000 through 6999.
The following list provides examples of support systems:
• Uninterruptible power supply
• Water supply
Temperature message codes (7000-7999)

The temperature message code category includes message codes from 7000 through 7999.
7010, page 1347
7011, page 1347
7012, page 1348
7013, page 1348
7014, page 1348
7015, page 1349
7016, page 1349
7017, page 1349
7018, page 1350
7020, page 1350

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Troubleshooting
7021, page 1350

7022, page 1351
7023, page 1351
7024, page 1351
7025, page 1351
7026, page 1352
7027, page 1352
7028, page 1352
7050, page 1352
7051, page 1352
Message code: 7010

Water bath temperature out of range. Temperature (0).
0 = Temperature
The water in the water bath is not circulating because Change the water in the water bath. Perform Daily
the system was idle for an extended period of time. maintenance procedure 5501 Daily Maintenance
The system was recently powered on. Check the temperature status to verify that the
temperature returns to specifications. Perform
Temperature diagnostic procedure 4301 Temperature
Status (c‑series), page 885.
The water bath is filling after the system was idle for an Check the temperature status to verify that the
extended period of time. temperature returns to specifications. Perform
Temperature diagnostic procedure 4301 Temperature
Status (c‑series), page 885.
The room temperature is too high. Modify the room temperature to be within specifications.
See Environmental specifications and requirements,
page 461.
failure.
Message code: 7011

Ambient temperature out of range. Temperature (0).
0 = Temperature
The room temperature is too low. Modify the room temperature to be within specification.
page 461.

80000071-105 - 2018-09-10
Troubleshooting

The room temperature is too high. Modify the room temperature to be within specification.
page 461.
Message code: 7012

Temperature stability failed on (0).
0 = Mechanism
The specified heater is unable to maintain the 1. Observe the temperature status to verify the
temperature within specification. temperature. Perform Temperature diagnostic
procedure 1300 Temperature Status (i‑series), page
909.
error.
Message code: 7013

Unable to process test. Water bath temperature below minimum acceptable value.
A water bath level or temperature error occurred while Additional messages that are associated with this
the system was processing the test. message can be used to determine the appropriate
Message code: 7014

Unable to process test. Water bath temperature above maximum acceptable value.
A water bath level or temperature error occurred while Additional messages that are associated with this
the system was processing the test. message can be used to determine the appropriate

80000071-105 - 2018-09-10
Troubleshooting
Message code: 7015

Reagent carousel temperature (0) out of range (1).
0 = Temperature
1 = Low or High
The room temperature is too low. Modify the room temperature to be within specification.
page 461.
The room temperature is too high. Modify the room temperature to be within specification.
page 461.
The system was powered on recently. Observe the temperature status to verify the
temperature. Perform Temperature diagnostic procedure
4301 Temperature Status (c‑series), page 885.
failure.
Message code: 7016

Reagent carousel temperature (0) out of range (1) while processing module powered off.
0 = Temperature
1 = Low or high
The reagent carousel temperature was not maintained Observe the temperature status to verify the
while the processing module was powered off. temperature. Perform Temperature diagnostic procedure
4301 Temperature Status (c‑series), page 885.
failure.
Message code: 7017

Reagent carousel temperature control hardware error on (0).
0 = Mechanism
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 7018

Reagent carousel temperature controller board communication error.
The module temperature controller board has a poor Cycle power to the processing module and the reagent
connection or has failed. and sample manager (RSM), page 484.
failure.
Hardware failure. Contact Customer Service. Provide information about
occurred.
Message code: 7020

(2) (3) temperature error.
2 = Board
3 = Mechanism
A temperature error occurred. Start the processing module and the reagent and sample
Communication or hardware failure. Cycle power to the processing module and the reagent
failure.
Message code: 7021

(0) above maximum temperature.
0 = Mechanism
The room temperature is out of specifications. Modify the room temperature to be within specifications.
page 461.
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 7022

(0) below minimum temperature.
0 = Mechanism
The room temperature is out of specifications. Modify the room temperature to be within specifications.
page 461.
failure.
Message code: 7023

Reagent supply center coolant level low.
The coolant level is low. Contact Customer Service to replace the coolant.
Message code: 7024

(0) temperature alarm. Temperature (1).
0 = Mechanism
1 = Temperature
A temperature alert occurred. Status message. No corrective action is required.
Message code: 7025

(0) temperature error.
0 = Mechanism
A temperature error has occurred. Additional messages that are associated with this

80000071-105 - 2018-09-10
Troubleshooting
Message code: 7026

Reagent storage area coolant error.
A reagent storage area coolant error occurred. Additional messages that are associated with this
Message code: 7027

Reagent storage area coolant level below middle level.
The coolant level is nearing the low level. Contact Customer Service to replace the coolant.
Message code: 7028

Thermo-electric controller error (0).
0 = Error
failure.
Message code: 7050

Reagent supply center coolant level empty.
The coolant level is empty. Contact Customer Service to replace the coolant.
Message code: 7051

Reagent supply center coolant sensors are disconnected.
The coolant sensors are disconnected. Verify that the coolant sensor connections are

80000071-105 - 2018-09-10
Troubleshooting

failure.
Computer hardware peripheral message codes (8000-8999)

The computer hardware peripheral message code category includes message codes from 8000
through 8999. The following list provides examples of computer hardware peripherals:
• Host interface
• Computer and monitor
• Media
• Ports
8000, page 1355
8001, page 1355
8002, page 1355
8003, page 1356
8004, page 1356
8005, page 1356
8006, page 1356
8007, page 1357
8008, page 1357
8010, page 1357
8011, page 1357
8012, page 1358
8013, page 1358
8016, page 1358
8017, page 1358
8018, page 1359
8020, page 1359
8021, page 1360
8022, page 1360
8023, page 1360
8024, page 1361

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Troubleshooting
8026, page 1362

8027, page 1362
8028, page 1362
8029, page 1363
8034, page 1363
8036, page 1363
8037, page 1363
8038, page 1364
8040, page 1364
8041, page 1364
8042, page 1365
8043, page 1365
8046, page 1365
8047, page 1365
8048, page 1366
8049, page 1366
8050, page 1366
8052, page 1367
8053, page 1367
8054, page 1367
8055, page 1368
8070, page 1368
8071, page 1368
8072, page 1369
8073, page 1369
8074, page 1369
8075, page 1369
8076, page 1369
8077, page 1370
8078, page 1370
8079, page 1370
8080, page 1370
8081, page 1371
8082, page 1371
8083, page 1371
8084, page 1371
8085, page 1371
8086, page 1372
8087, page 1372

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Troubleshooting
8088, page 1372

8089, page 1372
8090, page 1373
8091, page 1373
8092, page 1373
8093, page 1373
8094, page 1374
8095, page 1374
8096, page 1374
8102, page 1374
8103, page 1375
8104, page 1375
8105, page 1375
8113, page 1376
8114, page 1376
8115, page 1376
8116, page 1377
8117, page 1377
8118, page 1377
Message code: 8000

AbbottLink communications restored.
The connection to AbbottLink was restored. Status message. No corrective action is required.
Message code: 8001

AbbottLink communication is offline.
AbbottLink communication is Offline. • Restart AbbottLink, page 537.
• Contact Customer Service to resolve the AbbottLink
failure.
Message code: 8002

Status for (0) printer unavailable at this time.
0 = Printer

80000071-105 - 2018-09-10
Troubleshooting

The printer is not available. • Verify that the printer is plugged in, turned on, and
ready.
• Verify that the cable from the printer to the
computer is plugged in.
• Refer to the printer documentation for more
information.
Message code: 8003

Unknown printer error occurred for (0) printer.
0 = Printer
A printer error occurred. Refer to the printer documentation for more information.
Message code: 8004

Printer error (0) occurred for (1) printer.
0 = Printer error
1 = Printer
A printer error occurred. Refer to the printer documentation for more information.
Message code: 8005

Host communication error. Message queue full for data pending transmission.
The message queue is full. Clear the message queue and enable the host
connection on the Host Connection Status flyout.
Perform Enable or disable the host connection, page
531.
Message code: 8006

Host communication error. Unknown error occurred when transmitting data to host.

80000071-105 - 2018-09-10
Troubleshooting

An unknown error was detected when data was • Verify that the host communication is enabled on
transmitted to the host. the Host Connection Status flyout. Perform Enable
or disable the host connection, page 531.
• Cycle power to the system, page 480.
• Refer to the host communications documentation
for more information.
Message code: 8007

Host message queue cleared by operator ID (0).
0 = Operator ID
The message queue was cleared by the operator. Status message. No corrective action is required.
Message code: 8008

Host connection disabled by operator ID (0).
0 = Operator ID
The operator disabled the host connection. Status message. No corrective action is required.
Message code: 8010

Host connection enabled by operator ID (0).
0 = Operator ID
The operator enabled the host connection. Status message. No corrective action is required.
Message code: 8011

Host connection disabled. Message queue full.
The message queue is full. Clear the message queue and enable the host
connection on the Host Connection Status flyout.

80000071-105 - 2018-09-10
Troubleshooting

Perform Enable or disable the host connection, page
531.
Message code: 8012

Invalid host cancellation request. SID (0) does not exist.
0 = SID
The system received a cancellation request from the If the error occurs frequently with no explanation, verify
host on a test order that does not exist in the database. the function of the host interface.
The cancellation request by the host is ignored by the
system.
Message code: 8013

Invalid host order for SID (0). Sample type of (1) invalid for order.
0 = SID
1 = Sample type
The host order for the SID is for an invalid sample type. Verify that the host is sending only specimen and control
orders.
Message code: 8016

Invalid host order for SID (0). No order data sent.
0 = SID
The host order for the SID does not contain order data. Verify the order in the Host Connection Status flyout.
Message code: 8017

Invalid host order for SID (0). Specified dilution (1) for assay (2) number (3) does not exist or is in
conflict with the specified dilution factor.
0 = SID
1 = Dilution

80000071-105 - 2018-09-10
Troubleshooting
2 = Assay name
3 = Assay number
The host order contains an invalid dilution option. Order a dilution that is available for the specified assay.
The dilution name is case sensitive. Verify that the host
dilution name is exactly the same as the dilution name in
the system software.
Message code: 8018

Negative query response received for SID (0).
0 = SID
• The SID was not recognized by the host. Verify that orders exist for the SID.
• The SID has no outstanding orders.
Message code: 8020

(0) request timed out.
0 = Mail category
AbbottLink did not respond to an automatic request or a
manual request for an assay file within the required time
period.
AbbottLink response is slow. • The download speed capability of the laboratory
affects the amount of time needed to process a
request. The status of an assay file request can
remain as Pending for a maximum of 24 hours
before the request times out.
• If a manual request for an assay file failed, repeat
the manual request.
• If an automatic request for an assay file failed, the
system will automatically request the assay file
again in 7 days. No corrective action is required.
The status of AbbottLink is Disconnected.
• The Ethernet cable has a poor connection. • Reconnect the Ethernet cable.
• The Internet connection of the laboratory is not • Reestablish the Internet connection.
functioning.
• AbbottLink at Abbott Laboratories is not • Contact Customer Service. Provide information
functioning. about the operation that was attempted when the
error occurred.

80000071-105 - 2018-09-10
Troubleshooting

failure.
Message code: 8021

Communications error occurred while requesting (0).
0 = Mail category
The status of AbbottLink is Disconnected. • Restart AbbottLink, page 537.
• Contact Customer Service. Provide information
error occurred.
After the AbbottLink connection is reestablished, to
request the assay insert again, unload the reagent and
reload the reagent.
Message code: 8022

Unexpected response received for (0).
0 = Mail category
An Abbott Mail item was received after a request for the Review the system logs for message code 8020.
item had previously timed out.
Message code: 8023

Communications error occurred during (1) request for reagent lot (0).
0 = Reagent lot
1 = Mail category
The status of AbbottLink is Disconnected. Refer to the assay insert that was shipped with the
• Restart AbbottLink, page 537.
error occurred.

80000071-105 - 2018-09-10
Troubleshooting

reload the reagent.
Message code: 8024

(1) request timed out for reagent lot (0).
0 = Reagent lot
1 = Mail category
AbbottLink did not respond to a request for an assay
insert within the required time period.
• AbbottLink response is slow. • The download speed capability of the laboratory
affects the amount of time needed to process a
request. The status of an assay insert request can
remain as Pending for a maximum of 24 hours
before the request times out.
• To request the assay insert again, unload the
reagent and reload the reagent.
• The status of AbbottLink is Disconnected. • Restart AbbottLink, page 537.
error occurred.
reload the reagent.
• The Ethernet cable has a poor connection. Reconnect the Ethernet cable.
• The Internet connection of the laboratory is not Reestablish the Internet connection.
functioning.
• AbbottLink at Abbott Laboratories is not Contact Customer Service. Provide information about
functioning. the operation that was attempted when the error
occurred.
• Hardware failure. Contact Customer Service to resolve any hardware
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 8026

File error (0) for mail item (1) for (2) number (3) revision (4).
0 = File error
1 = Mail category
2 = Subject
3 = Number
4 = Revision
A problem occurred with an Abbott Mail item that was Contact Customer Service. Provide information about
downloaded. the operation that was attempted when the error
occurred.
Message code: 8027

File error (0) for mail item (1) for (2) number (3) revision (4). Error (5).
0 = File error
1 = Mail category
2 = Subject
3 = Number
4 = Revision
5 = Error
occurred.
Message code: 8028

File error (0) for mail item (1) for (2) number (3).
0 = File error
1 = Mail category
2 = Subject
3 = Number
occurred.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 8029

Unable to connect to host. Unknown communication error.
An unknown error occurred when an attempt was made Contact Customer Service. Provide information about
to connect to the host. the operation that was attempted when the error
occurred.
Message code: 8034

Unable to print report. Printer error. Configuration option for automatic report printing turned off.
A printer error occurred. Resolve the printer error and set automatic report
generation to the default printer.
Message code: 8036

Connection error between SCM and processing module. Error (0).
0 = Error
Power to the processing module is turned off. Power on the processing module, page 489. Power on
The processing module is in the process of powering on. Wait until the processing module is powered on and the
instrument status of the module is Stopped.
Communication error. If the processing module stopped running because of
the communication error, perform Cycle power to the
processing module and the reagent and sample manager
(RSM), page 484.
The CPU board has a poor connection or has failed. Contact Customer Service to resolve any hardware
failure.
Message code: 8037

Invalid host order for SID (0). Assay (1) number (2) disabled.
0 = SID
1 = Assay name
2 = Assay number

80000071-105 - 2018-09-10
Troubleshooting

The system received a test order from the host that 1. Determine the cause for the disabled assay.
requested an assay that is disabled.
2. Enable the assay and run the test.
Message code: 8038

Invalid host order for SID (0). Assay number (1) not installed.
0 = SID
1 = Assay number
The system received a test order from the host that Install assay files, page 325.
requested an assay that is not installed.
The assay number is incorrectly defined in the host. Edit the assay number in the host.
Message code: 8040

Invalid host order. Order already exists for SID (0) assay (1) number (2) dilution (3).
0 = SID
1 = Assay name
2 = Assay number
3 = Dilution
The system received an order from the host that If the error continues, verify that the host interface is functioning
already exists. The system ignored the new correctly.
order.
Message code: 8041

Unspecified error received from host for SID (0) in Rack ID/Position (1/2) in RSM position (3).
0 = SID
1 = Rack ID
2 = Position
3 = Module/Position
An unspecified error was received from the host. Verify the host connection in the Host Connection Status
flyout.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 8042

Export error. Unable to export report to (0). Automatic report printing changed to Off.
0 = File location ID
An error occurred when data was exported to a USB Resolve the error with the USB flash drive. After the
flash drive. The automatic report printing is turned off. error is resolved, configure the automatic report
generation option to be Save to File.
Message code: 8043

Invalid host order for SID (0). Assay (1) number (2) is a correlation assay.
0 = SID
1 = Assay name
2 = Assay number
The host attempted to request an order for a correlation Verify the host interface.
assay, but the host cannot request an order for a
correlation assay.
Message code: 8046

Host query time-out exceeded for SID (0) in rack ID (1) position (2) RSM position (3).
0 = SID
1 = Rack ID
2 = Position
3 = Module/Position
The order query was not acknowledged by the host. Verify that the host communication is enabled in the
Host Connection Status flyout. Perform Enable or disable
the host connection, page 531.
Message code: 8047

Invalid host order. SID (0) contains invalid characters or is configured for a calibrator or control.
0 = SID

80000071-105 - 2018-09-10
Troubleshooting

The SID contains invalid characters. Verify the bar code format.
The SID for the specimen is already in use as a Verify the SID for the specimen.
calibrator SID or a control SID.
The bar code label does not meet specifications. Verify the bar code label meets specifications.
Message code: 8048

Invalid host order. AWOS ID (0) already exists.
0 = AWOS ID
The system received an order from the host, but the • Status message. No corrective action is required.
order already exists. The new order from the host is • If the error continues, contact Customer Service.
ignored. Provide information about the operation that was
Message code: 8049

Invalid host order for SID (0). Dilution protocol and manual dilution specified for assay (1) number (2).
0 = SID
1 = Assay name
2 = Assay number
The host order contained both a manual dilution factor Edit the host order to contain either a manual dilution
and an automatic dilution factor. The order can only factor or an automatic dilution factor.
contain one dilution factor type.
Message code: 8050

Invalid host order for SID (0). Specified manual dilution factor (1) is invalid or manual dilution is not
supported for assay (2) number (3).
0 = SID
1 = Dilution
2 = Assay name
3 = Assay number
A manual dilution option is unavailable for the requested Edit the host order to remove the manual dilution factor.
assay.

80000071-105 - 2018-09-10
Troubleshooting

The manual dilution factor is invalid for the requested Edit the host order to include a valid manual dilution
assay. factor.
Message code: 8052

Invalid host cancellation request. No pending order for SID (2) assay number (0) dilution (1) AWOS ID
(3).
0 = Assay number
1 = Dilution
2 = SID
3 = AWOS ID
The host cannot locate the order for cancellation. Status message. No corrective action is required.
occurred.
Message code: 8053

Invalid host cancellation request. No pending order for SID (2) assay number (0) dilution (1).
0 = Assay number
1 = Dilution
2 = SID
The host cannot locate the order for cancellation. Status message. No corrective action is required.
occurred.
Message code: 8054

File error (0) for mail item (1) for (2) number (3). Error (4).
0 = Mail file status
1 = Mail item
2 = Subject
3 = Number
4 = Error

80000071-105 - 2018-09-10
Troubleshooting

occurred.
Message code: 8055

Embedded computer (0) failed to boot up.
0 = Embedded computer
The RSM embedded computer failed to initialize. 1. Perform Cycle power to the processing module and
the reagent and sample manager (RSM), page 484
on the specified module.
2. If the RSM embedded computer fails to initialize,
perform Cycle power to the system, page 480.

occurred.
Message code: 8070

Unable to process test. A different LAS SID was presented before the LAS SID in process completed.
A different laboratory automation system (LAS) SID was Refer to the LAS vendor documentation for
presented to the module by the LAS before the LAS SID troubleshooting information.
in process was completed.
Message code: 8071

Unable to process test. LAS sample presentation error.
The laboratory automation system (LAS) failed to hold Refer to the LAS vendor documentation for
the sample tube in position during sample acquisition. troubleshooting information.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 8072

Unable to process test. The LAS released the LAS SID before the test completed.
The laboratory automation system (LAS) SID was Refer to the LAS vendor documentation for
released before the scheduled test was processed. troubleshooting information.
Message code: 8073

Unable to process test. The LAS canceled the LAS SID before the test completed.
The laboratory automation system (LAS) SID was Refer to the LAS vendor documentation for
canceled for the scheduled test in process. troubleshooting information.
Message code: 8074

Unable to process test. The required reagent cartridge to perform the LAS SID processing is mixing.
The reagent was still being mixed when the laboratory Refer to the LAS vendor documentation for
automation system (LAS) SID was presented to the troubleshooting information.
module for aspiration.
Message code: 8075

Host communication error. Improper message acknowledgment.
An unknown error was detected during a host 1. Retransmit the result that generated the error.
transmission.
2. If the error occurs frequently, contact Customer
Service.
Message code: 8076

Host transmission failure. Unable to transmit results.

80000071-105 - 2018-09-10
Troubleshooting

Host transmission failure. The system was unable to Transmit the result to the host. Perform Transmit a result
transmit results. or an exception to the host, page 727.
Message code: 8077

Host transmission failure. Unable to transmit assay calibration.
Host transmission failure. The result was not transmitted Transmit the assay calibration to the host. Perform
to the host. Transmit a calibration to the host, page 806.
Message code: 8078

LAS communication error. Improper message acknowledgment.
An unknown error was detected during a laboratory Refer to the LAS vendor documentation for
automation system (LAS) transmission. troubleshooting information.
Message code: 8079

Unable to process test. LAS communication error.
The laboratory automation system (LAS) was unable to Refer to the LAS vendor documentation for
determine whether a specimen moved during sample troubleshooting information.
acquisition.
Message code: 8080

LAS communication error. LAS rejected the transmitted message.
the specimen in position during aspiration. troubleshooting information.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 8081

LAS connection disabled by operator ID (0).
0 = Operator ID
The operator disabled the laboratory automation system Status message. No corrective action is required.
(LAS) connection.
Message code: 8082

LAS connection enabled by operator ID (0).
0 = Operator ID
The operator enabled the laboratory automation system Status message. No corrective action is required.
(LAS) connection.
Message code: 8083

LAS internal communication error.
occurred.
Message code: 8084

LAS communication error. LAS receiver channel is unable to establish connection.
The laboratory automation system (LAS) receiver Refer to the LAS vendor documentation for
channel was unable to establish a connection to the troubleshooting information.
user interface computer.
Message code: 8085

LAS communication error. LAS sender channel is unable to establish connection.

80000071-105 - 2018-09-10
Troubleshooting

The laboratory automation system (LAS) sender channel Refer to the LAS vendor documentation for
was unable to establish a connection to the LAS. troubleshooting information.
Message code: 8086

LAS message time-out error.
The laboratory automation system (LAS) did not receive 1. Verify the LAS communication, page 1467.
a reply message within the required time.
2. Refer to the LAS vendor documentation for
troubleshooting information.
Message code: 8087

LAS communication error. Unknown error occurred when the system transmitted data.
An unknown error was detected when the system 1. Verify the LAS communication, page 1467.
transmitted data to the laboratory automation system
2. Refer to the LAS vendor documentation for
(LAS).
troubleshooting information.
Message code: 8088

Invalid LAS (0). Duplicate command received.
0 = LAS command
The system received an existing laboratory automation Refer to the LAS vendor documentation for
system (LAS) command that is in process. The troubleshooting information.
command is ignored.
Message code: 8089

Invalid LAS (1). Command number (0) is not unique.
0 = Command number
1 = LAS command

80000071-105 - 2018-09-10
Troubleshooting

The system received a laboratory automation system Refer to the LAS vendor documentation for
(LAS) command that is not unique. troubleshooting information.
Message code: 8090

Unknown command message received from LAS.
The system received an unknown command message Refer to the LAS vendor documentation for
from the laboratory automation system (LAS). troubleshooting information.
Message code: 8091

Invalid LAS command. (1) is out of range for module (0).
0 = Module ID
1 = LAS command
The system received a laboratory automation system Refer to the LAS vendor documentation for
(LAS) command that is out of range for the module. troubleshooting information.
Message code: 8092

Invalid LAS command. (1) has invalid format for SID (0).
0 = SID
1 = LAS command
The SID format was invalid for the laboratory automation Refer to the LAS vendor documentation for
system (LAS) command. troubleshooting information.
Message code: 8093

Unexpected LAS (0). Clear command in process.
0 = LAS command

80000071-105 - 2018-09-10
Troubleshooting

A laboratory automation system (LAS) command cannot Refer to the LAS vendor documentation for
be sent while the Clear command is in process. troubleshooting information.
Message code: 8094

Unable to process LAS SID (0). Batch in process.
0 = SID
A laboratory automation system (LAS) specimen was Wait until the batch order is completed before running
detected while a batch order was in process. the LAS specimen.
Message code: 8095

Unable to process LAS SID (0). Starting or ending SID is used for a batch order.
0 = SID
The laboratory automation system (LAS) SID is the same Verify the SID for the LAS specimen.
as a starting SID or an ending SID used in a batch
order.
Message code: 8096

Unable to process LAS SID (0). SID configured for calibrator.
0 = SID
The SID is configured for a calibrator. Verify the SID for the laboratory automation system
(LAS) specimen.
Message code: 8102

Invalid host order for SID (2). New patient demographic (0) does not match existing patient demographic
(1).
0 = New demographic
1 = Existing demographic
2 = SID

80000071-105 - 2018-09-10
Troubleshooting

The host order already exists for the SID. The patient Create a host order with a new SID.
demographics do not match.
Message code: 8103

Unable to process LAS SID (0). SID configured for the control is in an incorrect format.
0 = SID
The SID that is configured for a control uses an Verify that the correct format is used to configure the
incorrect format. control SID.
Message code: 8104

Invalid host order for SID (3). Birth date (0) year, (1) month, (2) day is an incorrect format or greater
than the current date.
0 = Year
1 = Month
2 = Day
3 = SID
The host is sending an invalid birth date format. Verify that the host is sending the correct birth date
format of MM/DD/YYYY.
The host is sending a birth date that is greater than the Verify that the host is sending the correct birth date.
current date.
Message code: 8105

Invalid host order for SID (6). Draw date time (0) year, (1) month, (2) day, (3) hour, (4) minute, (5)
second is an incorrect format or greater than the current date.
0 = Year
1 = Month
2 = Day
3 = Hour
4 = Minute
5 = Second
6 = SID

80000071-105 - 2018-09-10
Troubleshooting

The host is sending an invalid specimen collection date Verify that the host is sending a valid specimen
format. collection date format of YYYYMMDDHHMMSS.
The host is sending a specimen collection date that is Verify that the host is sending the correct specimen
greater than the current date. collection date.
Message code: 8113

Host query is not performed for SID (0) in rack ID (1) position (2) RSM position (3)/(4) due to host
connection being down.
0 = SID
1 = Rack ID
2 = Position
3 = Module
4 = Position
The host connection is disabled. Enable the host connection in the Host Connection
Status flyout. Perform Enable or disable the host
connection, page 531.
Message code: 8114

Host communication error. Host sender channel is unable to establish connection.
The host sender channel is unable to establish a 1. Verify that the network connections are plugged in
connection. correctly.
2. Verify that the IP address and port number are
configured correctly.
3. Cycle power to the system, page 480.
4. Refer to the host communications document for
more information.
Message code: 8115

Host communication error. Host receiver channel is unable to establish connection.

80000071-105 - 2018-09-10
Troubleshooting

The host receiver channel is unable to establish a 1. Verify that the network connections are plugged in
connection. correctly.
2. Verify that the IP address and port number are
configured correctly.
3. Cycle power to the system, page 480.
4. Refer to the host communications document for
more information.
Message code: 8116

Host message time-out error.
The host did not receive a reply message within the 1. Status message. No corrective action is required.
required time, but the host connection is still enabled.
Message code: 8117

Unable to establish connection on communication channel.
The host connection could not be established. The host 1. Status message. No corrective action is required.
connection is still enabled and attempts to establish
communication.
Message code: 8118

LAS rejected message due to sample immobilization error detected during aspiration of sample (0).
0 = SID
the specimen in position during aspiration. troubleshooting information.

80000071-105 - 2018-09-10
Troubleshooting
Software message codes (9000-9999)

The software message code category includes message codes from 9000 through 9999.
9000, page 1381
9001, page 1381
9002, page 1382
9003, page 1382
9005, page 1382
9008, page 1383
9009, page 1383
9010, page 1383
9011, page 1383
9303, page 1384
9304, page 1384
9305, page 1384
9306, page 1384
9307, page 1385
9308, page 1385
9309, page 1385
9310, page 1385
9311, page 1386
9314, page 1386
9315, page 1386
9316, page 1387
9324, page 1387
9325, page 1387
9329, page 1387
9330, page 1388
9337, page 1388
9339, page 1388
9340, page 1389
9341, page 1389
9346, page 1389

80000071-105 - 2018-09-10
Troubleshooting
9348, page 1389

9349, page 1389
9350, page 1390
9351, page 1390
9352, page 1390
9355, page 1391
9356, page 1391
9357, page 1391
9358, page 1391
9359, page 1392
9360, page 1392
9361, page 1392
9362, page 1393
9363, page 1393
9364, page 1393
9365, page 1393
9366, page 1394
9367, page 1394
9368, page 1394
9369, page 1395
9370, page 1395
9371, page 1395
9372, page 1395
9374, page 1396
9375, page 1396
9376, page 1396
9377, page 1396
9378, page 1397
9379, page 1397
9380, page 1397
9381, page 1398
9382, page 1398
9383, page 1398
9384, page 1399
9385, page 1399
9386, page 1399
9387, page 1400
9388, page 1400
9389, page 1400

80000071-105 - 2018-09-10
Troubleshooting
9390, page 1401

9391, page 1401
9392, page 1401
9393, page 1401
9394, page 1402
9395, page 1402
9397, page 1402
9398, page 1403
9399, page 1403
9400, page 1403
9402, page 1403
9403, page 1404
9404, page 1404
9405, page 1404
9406, page 1404
9407, page 1405
9408, page 1405
9409, page 1405
9410, page 1405
9412, page 1406
9413, page 1406
9414, page 1406
9415, page 1406
9416, page 1407
9417, page 1407
9418, page 1407
9419, page 1407
9421, page 1408
9422, page 1408
9423, page 1408
9424, page 1408
9426, page 1409
9427, page 1409
9428, page 1409
9429, page 1410
9430, page 1410
9431, page 1410
9432, page 1411
9433, page 1411

80000071-105 - 2018-09-10
Troubleshooting
9434, page 1411

9435, page 1412
9436, page 1412
9437, page 1412
9438, page 1413
9441, page 1413
9442, page 1413
9443, page 1414
9444, page 1414
9445, page 1414
9446, page 1414
9447, page 1415
9448, page 1415
9449, page 1415
9528, page 1415
9529, page 1416
9530, page 1416
9999, page 1416
Message code: 9000

Call Abbott. Runtime error occurred while running (0) (1): (2).
1 = Procedure name
2 = Exception message
An error occurred when a maintenance procedure was 1. Review the Maintenance screen.
run.
Message code: 9001

Call Abbott. Procedure file (0) is invalid.
0 = Decryption error message
Procedure file error. Contact Customer Service. Provide information about
occurred.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 9002

Runtime error occurred while (0) (1) was running. Consecutive command errors occurred.
1 = Procedure name
occurred.
Message code: 9003

Call Abbott. Unable to create or update (0) (1) version (2). Error occurred: (3).
1 = Procedure name
occurred.
Message code: 9005

Unable to export (0) (1) version (2) to (3). Error occurred: (4).
1 = Procedure name
3 = USB flash drive
An error occurred while exporting files to a USB flash Review the specific message text. Perform the
drive. corrective action for the specific message text.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 9008

Pipettor operation detected a timing error.
A timing error occurred during a pipettor operation. Rerun the test. Perform Rerun a test or an exception for
a specimen or control, page 703.
Message code: 9009

Lockstep operation detected a timing error between (0) and (1).
0 = Mechanism
1 = Mechanism
The operator cannot perform an operation on the device Start the processing module and the reagent and sample
that was indicated because of a conflict with another manager (RSM), page 500.
device.
The operator selected the Stop button while the Start the processing module and the reagent and sample
instrument status of a processing module is Running. manager (RSM), page 500.
Previous hardware failure. Contact Customer Service to resolve any hardware
failure.
occurred.
Message code: 9010

Call Abbott. Motor command sent to R1 pipettor when reagent carousel was rotating.
occurred.
Message code: 9011

Call Abbott. Motor command sent to R2 pipettor when reagent carousel was rotating.

80000071-105 - 2018-09-10
Troubleshooting

occurred.
Message code: 9303

Call Abbott. Calibration failed for assay (0) number (1). Unknown math model.
0 = Assay name
1 = Assay number
occurred.
Message code: 9304

Invalid read interval during data processing.
occurred.
Message code: 9305

Calibration failed for assay (0) number (1). Memory allocation error.
0 = Assay name
1 = Assay number
occurred.
Message code: 9306

Call Abbott. Calibration adjustment method (0) is not defined.

80000071-105 - 2018-09-10
Troubleshooting
0 = Calibration adjustment method

occurred.
Message code: 9307

Call Abbott. Calibration method (0) is not defined.
0 = Calibration method
occurred.
Message code: 9308

Call Abbott. (0) formula contains unknown variables (1).
0 = Formula
1 = Unknown variable
occurred.
Message code: 9309

Call Abbott. An AbbottLink request message contains invalid parameters.
occurred.
Message code: 9310

Unable to retrieve requested (0) (1) log.

80000071-105 - 2018-09-10
Troubleshooting
0 = Log component
1 = Log name
The requested log file cannot be retrieved by AbbottLink. Restart AbbottLink, page 537.
Time-out occurred during log file retrieval to AbbottLink. Contact Customer Service. Provide information about
occurred.
Message code: 9311

Call Abbott. Unexpected archive failure.
An unexpected error occurred when an archive was • Archive the file again. Perform Archive the results,
attempted. page 761.
error occurred.
Message code: 9314

Call Abbott. Software ICS application error.
An error occurred when the informatics reply was Contact Customer Service. Provide information about
processed. the operation that was attempted when the error
occurred.
Message code: 9315

Call Abbott. Software unable to convert message to HL7.
A software error occurred with the HL7 communication. Contact Customer Service. Provide information about
occurred.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 9316

Call Abbott. Software version mismatch.
A software version mismatch error occurred. Contact Customer Service. Provide information about
occurred.
Message code: 9324

Error occurred setting mail language to (0). Mail language will default to English.
0 = Language
The operator configured a mail language that is not • Cycle power to the system, page 480.
supported by the operating system. • If the error continues, contact Customer Service.
Message code: 9325

Invalid mail language (0).
0 = Language
An invalid mail language was detected during software • Cycle power to the system, page 480.
startup. • If the error continues, contact Customer Service.
Message code: 9329

Call Abbott. Software database error.
occurred.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 9330

Lockstep timing error on (0).
0 = Device
The operator cannot perform an operation on the device Start the processing module and the reagent and sample
that was indicated because of a conflict with another manager (RSM), page 500.
device.
The operator selected the Stop button while the Start the processing module and the reagent and sample
instrument status of a processing module is Running or manager (RSM), page 500.
Processing.
Previous hardware failure. Contact Customer Service to resolve any hardware
failure.
occurred.
Message code: 9337

Firmware update failed on (0) board.
0 = Board
occurred.
Message code: 9339

File transfer error between SCM and processing module. Error (0).
0 = Transfer error
Power to the processing module is turned off. Power on the processing module, page 489.
The processing module is in the process of powering on. Wait until the processing module is powered on and the
instrument status of the module is Stopped.
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 9340

Call Abbott. Unable to calculate result. Optical read data not received from processing module.
occurred.
Message code: 9341

Call Abbott. Invalid optical read data received from processing module.
occurred.
Message code: 9346

Successfully updated database (0) from version (1) to version (2).
0 = Database
1 = Version from
2 = Version to
The database was updated. Status message. No corrective action is required.
Message code: 9348

Call Abbott. Software error.
occurred.
Message code: 9349

CPU firmware update failed.

80000071-105 - 2018-09-10
Troubleshooting

occurred.
Message code: 9350

DAQ firmware update failed.
occurred.
Message code: 9351

Unknown processing module error (0).
0 = Error
occurred.
failure.
Message code: 9352

Unable to add backup data to backup file (0).
0 = Backup file
The system is unable to perform a backup. 1. Cycle power to the system, page 480.
2. Perform a manual backup, page 382.

occurred.

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Troubleshooting
Message code: 9355

System backup completed with error.
The backup process was completed, but the software • Copy a backup to a USB flash drive, page 383.
was unable to copy the backup to the specified location. • Contact Customer Service. Provide information
error occurred.
Message code: 9356

System backup (0) copied to external storage location (1).
0 = Backup file name
1 = File location
The backup has been copied to an external storage Status message. No corrective action is required.
location.
Message code: 9357

System software version not compatible. Version (0) required but version (1) installed.
0 = Version required
1 = Version installed
The system attempted to install an invalid assay version. Obtain a new assay file for installation. Perform Install
assay files, page 325.
Message code: 9358

(1) occurred during backup process (0). Backup did not complete successfully.
0 = Backup process
1 = Error
The system is unable to complete the backup 1. Cycle power to the system, page 480.
successfully.

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Troubleshooting

2. Perform a manual backup, page 382.
error occurred.
Message code: 9359

Unable to copy or export completed backup file to location. (0).
0 = File location
A copy of the backup file exists at the export location. Select a different backup file or a different export
location.
Message code: 9360

Unable to copy or export backup file. (0).
0 = Error
The system was unable to copy the backup file because 1. Perform a manual backup, page 382.
the file does not exist on the system.
2. Copy a backup to a USB flash drive, page 383.
error occurred.
Message code: 9361

Export of backup files completed successfully.
The backup file was copied and exported successfully Status message. No corrective action is required.
to a USB flash drive.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 9362

Unable to copy backup to external location. (0) error.
0 = Error
The backup file was not copied to the external location. • Verify that the correct USB flash drive was
selected.
• Verify that the USB flash drive is not full.
• Use a new USB flash drive.
error occurred.
Message code: 9363

Software performed (0) during backup process.
0 = Database repair
The software performed the indicated database repair Status message. No corrective action is required.
during the backup process.
Message code: 9364

Unable to create backup file. (0) (1).
0 = File included in backup
1 = Error
The system was unable to create a backup file. • Perform a manual backup, page 382.
error occurred.
Message code: 9365

Unable to perform system backup. System not in correct status.
The instrument is not in the correct status to perform the • Perform a manual backup, page 382.
system backup.

80000071-105 - 2018-09-10
Troubleshooting

error occurred.
Message code: 9366

Unexpected (0) error occurred after backup failed.
0 = Error
An unexpected error occurred after a backup process • Perform a manual backup, page 382.
failed. • Contact Customer Service. Provide information
error occurred.
Message code: 9367

Unable to delete (0) from backup.
0 = File name
The system was unable to delete a file during the • Perform a manual backup, page 382.
backup process. • Contact Customer Service. Provide information
error occurred.
Message code: 9368

Unable to complete system restore. (1) error occurred while deleting the current database (0).
0 = Database name
1 = Error
The current database cannot be deleted before the Contact Customer Service. Provide information about
database is restored. the operation that was attempted when the error
occurred.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 9369

Maximum number of backups exceeded. (0) backup deleted from external storage.
The maximum number of external backups was Status message. No corrective action is required.
exceeded. The oldest backup was deleted.
Message code: 9370

Maximum number of backups exceeded. (0) backup deleted from internal storage.
The maximum number of internal backups was Status message. No corrective action is required.
exceeded. The oldest backup is deleted.
Message code: 9371

System restore not performed. Backup archive does not match (0) manifest file.
0 = Manifest file
The manifest file for the backup does not match the 1. Restore the database from a previously stored
manifest file for the previously stored backup. backup.
Message code: 9372

System restore not performed. (0) manifest file invalid.
0 = Manifest file
The manifest file could not be read. 1. Restore the database from a previously stored
backup.

80000071-105 - 2018-09-10
Troubleshooting

Message code: 9374

Manual backup (0) initiated.
A manual backup was initiated. Status message. No corrective action is required.
Message code: 9375

System backup (0) completed with error.
The system backup was completed successfully, but the • Perform a manual backup, page 382.
backup file contained warnings. • Contact Customer Service. Provide information
error occurred.
Message code: 9376

Scheduled automatic backup not performed.
The scheduled automatic backup was not performed Status message. No corrective action is required.
because the system was powered off.
Message code: 9377

System restore not performed. Unable to extract data from (0) backup file.

80000071-105 - 2018-09-10
Troubleshooting

Data was unable to be extracted from the backup file. 1. Restore the database from a different previously
stored backup.
Message code: 9378

System restore not performed. (0) backup archive file not found.
The backup file could not be accessed. 1. Restore the database from a different previously
stored backup.
Message code: 9379

System restore (0) completed successfully.
The system restore was completed successfully. Status message. No corrective action is required.
Message code: 9380

System restore not performed. (1) error occurred while restoring (0) database.
0 = Database name
1 = Error
The current database could not be restored. 1. Restore the database from a different previously
stored backup.

80000071-105 - 2018-09-10
Troubleshooting

Message code: 9381

System restore not performed. (1) error occurred while restoring (0) directory.
0 = Directory
1 = Error
stored backup.
Message code: 9382

System restore not performed. (1) error occurred while restoring (0) file.
0 = File name
1 = Error
The current backup could not be restored. 1. Restore the database from a different previously
stored backup.
Message code: 9383

System restore not performed. Unable to extract manifest from (0) backup file.

80000071-105 - 2018-09-10
Troubleshooting

stored backup.
Message code: 9384

System restore not performed. Restore manifest does not match selected (0) backup.
The manifest file for the system restore does not match 1. Restore the database from a different previously
the manifest file for the selected backup. stored backup.
Message code: 9385

System restore not performed. Restore manifest (0) not found.
0 = Manifest file name
The manifest file was not found during the system 1. Restore the database from a different previously
restore. stored backup.
Message code: 9386

System restore failed. Software unable to restore current backup due to (0) error.
0 = Error

80000071-105 - 2018-09-10
Troubleshooting

The current backup could not be restored. 1. Restore the database from a different previously
stored backup.
Message code: 9387

System backup failed. (0).
0 = Error
The system backup could not be performed. • Perform a manual backup, page 382.
error occurred.
Message code: 9388

System restore from (0) backup started.
The system restore process was initiated. Status message. No corrective action is required.
Message code: 9389

Unexpected error (0) occurred while performing automatic backup.
0 = Error
An error occurred when an automatic backup was • Perform a manual backup, page 382.
performed. • Contact Customer Service. Provide information
error occurred.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 9390

Unexpected error (0) occurred while performing backup.
0 = Error
An error occurred when the backup was performed. • Perform a manual backup, page 382.
error occurred.
Message code: 9391

Unexpected error (0) occurred while performing file export.
0 = Error
An error occurred when the procedure to copy a backup • Perform Copy a backup to a USB flash drive, page
to a USB flash drive was performed. 383.
error occurred.
Message code: 9392

Unexpected error (0) occurred while performing requested operation.
0 = Error
An error occurred when the backup was performed. • Perform a manual backup, page 382.
error occurred.
Message code: 9393

Unexpected error (0) occurred while completing system restore.
0 = Error
An error occurred during a cleaning of the internal • Cycle power to the system, page 480.
restore directory after a backup was restored.

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Troubleshooting

error occurred.
Message code: 9394

System restore not performed. Unexpected error (0) occurred.
0 = Error
An error occurred when the system restore was 1. Restore the database from a previously stored
performed. backup.
Message code: 9395

(1) error occurred while getting available backups and accessing (0) file.
0 = File name
1 = Error
An error occurred when available backup files were • Perform a manual backup, page 382.
accessed. • Contact Customer Service. Provide information
error occurred.
Message code: 9397

Unable to send CLI command. Instrument is offline.
The instrument is Offline. Verify that the instrument is powered on.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 9398

Timeout occurred waiting for CLI command response.
The system was unable to perform the requested CLI Contact Customer Service. Provide information about
command. the operation that was attempted when the error
occurred.
failure.
Message code: 9399

Unknown error sending CLI command.
occurred.
Message code: 9400

Unable to retrieve selected troubleshooting package.
The USB flash drive storage capacity is full. Use a USB flash drive with enough storage capacity to
retrieve the troubleshooting package.
The system was unable to retrieve the troubleshooting Contact Customer Service. Provide information about
package. the operation that was attempted when the error
occurred.
Message code: 9402

(1) error occurred extracting (0) package.
0 = Package name
1 = Error
occurred.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 9403

(1) error occurred signing (0) package.
0 = Package name
1 = Error
occurred.
Message code: 9404

(1) error occurred counter signing (0) package.
0 = Package name
1 = Error
occurred.
Message code: 9405

(1) error occurred creating (0) package.
0 = Package name
1 = Error
occurred.
Message code: 9406

(1) error occurred verifying (0) package.
0 = Package name
1 = Error

80000071-105 - 2018-09-10
Troubleshooting

occurred.
Message code: 9407

System update completed successfully.
The system update completed successfully. Status message. No corrective action is required.
Message code: 9408

Unable to connect to the system during the power on process. IP address (0) invalid.
0 = IP address
The host IP address is invalid. 1. Verify the host IP address. Perform Verify the HL7
communication, page 1466 or Verify the ASTM
communication, page 1468.
2. Request the system package download.
Message code: 9409

Unknown system update download request received for (0).
0 = System update file
occurred.
Message code: 9410

System update (0) download requested.
0 = System update file

80000071-105 - 2018-09-10
Troubleshooting

A download was requested for a system update. Status message. No corrective action is required.
Message code: 9412

Unexpected error occurred while scheduling automatic backup (0). Automatic backup function may not
be available.
0 = Automatic backup
Software error. • Perform a manual backup, page 382.
error occurred.
Message code: 9413

Unable to complete installation of system update due to startup error (1). Telnet IP address (0).
0 = Telnet IP address
1 = Error
The system update was unable to be completed Request the system update again.
because of a startup failure.
occurred.
Message code: 9414

System update status changed to (0).
0 = System update status
The system update status was changed. Status message. No corrective action is required.
Message code: 9415

Processing module (c‑series) error. (0) (1,4:X4)/(2,4:X4)/(3,4:X4).

80000071-105 - 2018-09-10
Troubleshooting

occurred.
Message code: 9416

Call Abbott. Calibration file (0) error.
0 = File name
occurred.
Message code: 9417

Unable to execute CLI command. Unknown return code (0).
0 = Return code
An invalid CLI command was entered. Enter a valid CLI command.
occurred.
Message code: 9418

Unable to process test. Internal software error.
occurred.
Message code: 9419

Unable to process test. Incomplete results found during system startup.

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Troubleshooting

An unexpected error occurred or the system stopped Rerun the test. Perform Rerun a test or an exception for
before the test result was completed. a specimen or control, page 703.
occurred.
Message code: 9421

Unable to process test. Internal software error.
occurred.
Message code: 9422

Software error. Configuration file read error (0).
0 = Error
occurred.
Message code: 9423

(0) board firmware not updated.
0 = Board
occurred.
Message code: 9424

Archive failed. Unexpected error.

80000071-105 - 2018-09-10
Troubleshooting

The archive to the USB flash drive failed. Archive the file again with a different USB flash drive.
occurred.
Message code: 9426

Error writing pipettor calibration data to file.
The software is unable to store the pipettor calibration 1. Repeat the applicable pipettor diagnostic
data. procedure. Perform Pipettors diagnostic procedure
1111 Sample Pipettor Check and Calibration
(i‑series), page 895, 1112 R1 Pipettor Check and
Calibration (i‑series), page 895, or 1113 R2 Pipettor
Message code: 9427

Unable to execute CLI command. (0) command is invalid.
0 = CLI command
occurred.
failure.
Message code: 9428

Unable to execute CLI command. (0) file is invalid.
0 = File name

80000071-105 - 2018-09-10
Troubleshooting

occurred.
failure.
Message code: 9429

(0) CLI command received an unspecified error response.
0 = CLI command
occurred.
failure.
Message code: 9430

Unable to execute CLI command. Incorrect number of CLI parameters (0).
0 = Number of parameters
occurred.
failure.
Message code: 9431

Unable to execute CLI command. Incorrect number of parameters (0).
0 = Number of parameters
occurred.

80000071-105 - 2018-09-10
Troubleshooting

failure.
Message code: 9432

Unable to execute CLI command. Incorrect parameter value (0).
0 = Parameter value
occurred.
failure.
Message code: 9433

Unable to execute CLI command. (0) process is unavailable.
0 = Software process
occurred.
failure.
Message code: 9434

Unable to execute CLI command. (0) failed.
0 = CLI error
occurred.
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 9435

Software error. Control configuration corrupted for lot (0).
0 = Control lot
An error occurred in the configured quality control file Manually create a new quality control lot, page 349.
for the indicated lot number.
occurred.
Message code: 9436

CLI Command Error. (0).
0 = Error
A hardware error occurred during a maintenance or 1. Review the specific message text. Perform the
diagnostic procedure. corrective action for the specific message text.
failure.

occurred.
Message code: 9437

Module (0) (1) failed.
0 = Module
1 = Firmware board
The firmware upgrade was not completed. Cycle power to the indicated processing module.
Perform Cycle power to the processing module and the
occurred.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 9438

(0) initialization failed.
0 = Firmware board
A hardware initialization error occurred. Cycle power to the processing module. Perform Cycle
power to the processing module and the reagent and
failure.
Message code: 9441

Module (0) (1) upgrade error. File unreadable.
0 = Module
1 = Firmware board
A firmware board error occurred during an upgrade. Cycle power to the indicated processing module.
failure.
Message code: 9442

Module (0) (1) application not responding.
0 = Module
1 = Firmware board
The high availability monitor detected an error. Cycle power to the indicated processing module.
failure.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 9443

Unable to process test. Unit conversion formula (0) error.
0 = Formula
The unit conversion formula evaluation failed. Rerun the test. Perform Rerun a test or an exception for
a specimen or control, page 703.
occurred.
Message code: 9444

Unable to open calibrator data file (0). Invalid file.
0 = Calibrator data file
Software error. The calibrator file is damaged or Contact Customer Service. Provide information about
corrupted. the operation that was attempted when the error
occurred.
Message code: 9445

Calibrator data file (0) not accessible.
0 = Calibrator data file
Software error. The calibrator file is damaged or Contact Customer Service. Provide information about
corrupted. the operation that was attempted when the error
occurred.
Message code: 9446

Quality control data file (0) does not contain printable quality control insert.
0 = Control data file
Software error. The file is damaged or corrupted. Contact Customer Service. Provide information about
occurred.

80000071-105 - 2018-09-10
Troubleshooting
Message code: 9447

Call Abbott. Unsupported reagent at RSM location (0).
0 = RSM location
The system is not configured to support the reagent. Contact Customer Service to resolve the software
configuration error.
Message code: 9448

Embedded software (0) upgrade failed.
The software upgrade for the embedded computer Perform Cycle power to the processing module and the
failed. reagent and sample manager (RSM), page 484 on the
specified module.
occurred.
Message code: 9449

Embedded computer file corrupted (0).
occurred.
Message code: 9528

Firmware update started for (0) board. Wait for firmware update to complete.
0 = Board

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Troubleshooting

An update to the firmware is in process for the specified Status message. No corrective action is required.
board.
Message code: 9529

Firmware update completed for (0) board.
0 = Board
An update to the firmware has completed for the Status message. No corrective action is required.
specified board.
Message code: 9530

Firmware update completed for (0). Cycle power to module (1).
0 = CCPM board
1 = Module
An update to the firmware has completed. Cycle power to the specified processing module.
Message code: 9999

Call Abbott.
occurred.

80000071-105 - 2018-09-10
Troubleshooting
Section 10 Observed problems
Observed problems
Observed problems provide information about problems that may occur on the system and
provide corrective actions that help to resolve the problems.
If the corrective actions for an observed problem do not resolve the problem, contact the local
NOTE: Corrective actions may involve hazardous activity. Use caution to minimize operator
exposure and to prevent personal injury or system damage. Examples of hazardous activities
include:
• The replacement of system probes.
• The use of reagents, calibrators, controls, and specimens.
• The removal of physical obstructions.
• The removal of system waste.
Processing module observed problems, page 1417
Processing module observed problems (c‑series), page 1418
Processing module observed problems (i‑series), page 1422
Sample results observed problems (c‑series), page 1424
Sample results observed problems (i‑series), page 1435
User interface (UI) computer observed problems, page 1446
Printer observed problems, page 1446
Processing module observed problems

Processing module observed problems include problems that may occur on a processing
module.
A procedure failed and a procedure item remained in the reagent carousel, page 1417
A procedure failed and a procedure item remained in the reagent carousel

A procedure failed before a procedure item was • Verify that the processing module status with the
removed from the reagent carousel. procedure item is Idle, Running, or Processing.
If the processing module status is Stopped, perform
Start the processing module and the reagent and

80000071-105 - 2018-09-10
Troubleshooting
Observed problems Section 10

• To transition the RSM status to Running, perform
When the RSM status is Running, the procedure
item is removed from the reagent carousel.
Processing module observed problems, page 1417
Processing module observed problems (c‑series)

Processing module observed problems for c‑series include problems that may occur on the
c‑series processing module.
1 mL wash solution syringe leaks (c‑series), page 1418
Bubbles in ICT module tubing (c‑series), page 1419
Bubbles in sample or reagent probe tubing (c‑series), page 1419
Bubbles in the sample or reagent syringes (c‑series), page 1420
ICT aspiration pump syringe or ICT Reference Solution pump syringe leaks (c‑series), page 1420
ICT probe leaks (c‑series), page 1420
Lamp is not on (c‑series), page 1421
Liquid at the top of the cuvettes after washing (c‑series), page 1421
Mixer is bent or is making an unexpected noise (c‑series), page 1421
Reagent probe tubing is discolored or contains precipitate (c‑series), page 1421
Sample or reagent probe is damaged or clogged (c‑series), page 1422
Sample or reagent probe tubing leaks (c‑series), page 1422
Sample or reagent syringe leaks (c‑series), page 1422
1 mL wash solution syringe leaks (c‑series)

The syringe is not tightened at the check valve Tighten the check valve connection.
connection.
The syringe plunger is damaged. Replace the 1 mL syringes (c‑series), page 958.
The check valve is defective. Replace the check valves (c‑series), page 961.
The tubing is crimped or damaged. Contact Customer Service to resolve any hardware
failure.

80000071-105 - 2018-09-10
Troubleshooting
Bubbles in ICT module tubing (c‑series)

The ICT Reference Solution reservoir is empty, but the 1. Replace the ICT Reference Solution bottle. Perform
bottle sensor failed to detect it. Replace bulk solutions and update the inventory,
page 579.
failure.
The ICT module O-rings are missing or are not seated Reseat the ICT module O-rings or remove the extra O-
correctly, or extra O-rings from a previous ICT module rings. If necessary, perform Replace the ICT module or
are present. the ICT probe (c‑series), page 952.
The ICT probe is not connected correctly. Tighten the probe to the ICT module by hand.
aspiration pump.
failure.
Bubbles in sample or reagent probe tubing (c‑series)

The tubing connection to the sample or reagent syringe Tighten the tubing connections to the syringe body.
is loose.
The probe tubing is damaged. Perform Replace the reagent probe tubing (c‑series),
page 933 or Replace the sample probe tubing (c‑series),
page 930.
A syringe seal or an O-ring has failed. Perform Quarterly maintenance procedure 5801 Sample
Syringe Maintenance (c‑series), page 860 or 5803
Reagent Syringe Maintenance (c‑series), page 862.
failure.

80000071-105 - 2018-09-10
Troubleshooting
Bubbles in the sample or reagent syringes (c‑series)

The tubing connection to the sample or reagent syringe Tighten the tubing connections to the syringe body.
is loose.
failure.
ICT aspiration pump syringe or ICT Reference Solution pump syringe leaks (c‑series)
The ICT aspiration pump syringe or the ICT Reference Replace the 1 mL syringes (c‑series), page 958.
Solution pump syringe is damaged.
The connections between the ICT aspiration pump Tighten the connections to the 1 mL syringes in the ICT
syringe or the ICT Reference Solution pump syringe and aspiration pump or the ICT Reference Solution pump.
the check valve or the tubing are loose.
ICT probe leaks (c‑series)

The ICT aspiration tubing is not connected correctly. Tighten the tubing connections.

80000071-105 - 2018-09-10
Troubleshooting
Lamp is not on (c‑series)

The cable terminals are not securely connected to the Perform Quarterly maintenance procedure 5806 Change
terminal block. Lamp (c‑series), page 862.
The lamp is out. Perform Quarterly maintenance procedure 5806 Change
Liquid at the top of the cuvettes after washing (c‑series)

The cuvette washer is not functioning correctly. Perform Weekly maintenance procedure 5601 Clean
Cuvettes with Detergent A (c‑series), page 859 and
observe the cuvette washer nozzles for hanging drops,
leaks, or blockage in the tubing.
Calibration (c‑series), page 878 or 4104 R2 Pipettor
failure.
Mixer is bent or is making an unexpected noise (c‑series)

A mixer is installed incorrectly or is out of alignment. Replace the mixers (c‑series), page 948.
Reagent probe tubing is discolored or contains precipitate (c‑series)

The reagent probe tubing is discolored or contains Replace the reagent probe tubing (c‑series), page 933.
precipitate.

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Troubleshooting
Sample or reagent probe is damaged or clogged (c‑series)

Particulate matter in the sample caused an obstruction Use a cleaning wire to dislodge particulate matter from
in the probe. the probe.
The sample or reagent probe is damaged. Replace the damaged probe. Perform Replace the
sample probe (c‑series), page 922 or Replace the
reagent probes (c‑series), page 925.
Sample or reagent probe tubing leaks (c‑series)

The sample or reagent probe tubing is damaged. Replace the reagent probe tubing (c‑series), page 933 or
Replace the sample probe tubing (c‑series), page 930.
Sample or reagent syringe leaks (c‑series)

The tubing connection to the sample or reagent syringe Tighten the tubing connections to the sample or reagent
is loose. syringe.
failure.
Processing module observed problems (i‑series)

Processing module observed problems for i‑series include problems that may occur on the
i‑series processing module.

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Troubleshooting
Wash zone 1 or wash zone 2 wash monitoring test failure (i‑series), page 1423
Wash zone 1 or wash zone 2 wash monitoring calibration failure (i‑series), page 1424
Wash zone 1 or wash zone 2 wash monitoring test failure (i‑series)

For aspiration failures:
• The wash zone assembly is not seated correctly. 1. Loosen the knurled screws that secure the wash
• The knurled screws that secure the wash zone 1. Tighten the four knurled screws that secure the
assembly to the process path are loose. wash zone elevator assembly to the process path.
assembly.
• A wash zone probe is out of alignment. • Remove the wash zone probe. Realign the wash
zone probe in the wash zone probe housing.
Perform Replace the wash zone probes (i‑series),
page 1001.
• The wash zone tubing connections are loose or • Reconnect the wash zone tubing to the affected
leaking. probe for the indicated wash zone.
• A wash zone probe is obstructed. • Replace the wash zone probes (i‑series), page
1001.
• The wash monitoring system is not calibrated. • Perform the Calibration and Test option of
Fluidics-Wash diagnostic procedure 1261 Wash
Zone 1 Wash Monitoring (i‑series), page 908 or
1262 Wash Zone 2 Wash Monitoring (i‑series),
page 908.
• Hardware failure. • Contact Customer Service to resolve any hardware
failure.
For dispense failures:
• Bubbles are present in the wash buffer tubing. • Perform the Flush and Prime Manifolds option of
Fluidics-Wash diagnostic procedure 1200 Flush
• The diluted wash buffer level sensor is cracked. • Replace the diluted wash buffer level sensor
• The wash monitoring system is not calibrated. • Perform the Calibration and Test option of
Fluidics-Wash diagnostic procedure 1261 Wash
Zone 1 Wash Monitoring (i‑series), page 908 or
1262 Wash Zone 2 Wash Monitoring (i‑series),
page 908.
failure.

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Troubleshooting
Wash zone 1 or wash zone 2 wash monitoring calibration failure (i‑series)

For aspiration failures:
• A wash zone probe is out of alignment. • Remove the wash zone probe. Realign the wash
zone probe in the wash zone probe housing.
Perform Replace the wash zone probes (i‑series),
page 1001.
• The wash zone tubing connections are loose or • Reconnect the wash zone tubing to the affected
leaking. probe for the indicated wash zone.
• A wash zone probe is obstructed. • Replace the wash zone probes (i‑series), page
1001.
failure.
For dispense failures:
• Bubbles are present in the wash buffer tubing. • Perform the Flush and Prime Manifolds option of
Fluidics-Wash diagnostic procedure 1200 Flush
• The diluted wash buffer level sensor is cracked. • Replace the diluted wash buffer level sensor
failure.
Sample results observed problems (c‑series)

Observed problems for sample results include problems that occur with the sample results on
the c‑series processing module.
All ICT results have similar values: Na = 140, K = 4.0, Cl = 100 mmol/L (c‑series), page 1426
Controls out of range (c‑series), page 1427
Depressed concentration: ICT results entire run (c‑series), page 1427
Depressed concentration: ICT results single assay (c‑series), page 1428
Depressed concentration: K+ results single assay (c‑series), page 1428
Depressed concentration: Photometric results entire run (c‑series), page 1428
Depressed concentration: Photometric results single assay (c‑series), page 1429

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Troubleshooting
Elevated concentration: ICT results entire run (c‑series), page 1429

Elevated concentration: ICT results single assay (c‑series), page 1429
Elevated concentration: Photometric results single assay (c‑series), page 1430
Erratic results, poor precision: ICT results (c‑series), page 1430
Erratic results, poor precision: Photometric results (c‑series), page 1432
A#1 result flag (c‑series)

The sample concentration is too high. Dilute and rerun the sample. For the dilution protocol,
see the assay-specific reagent package insert.
For more information about sample integrity, see the
assay-specific reagent package insert.
The cuvettes are dirty. Perform Weekly maintenance procedure 5601 Clean
Cuvettes with Detergent A (c‑series), page 859.
observe the cuvette washer nozzles for hanging drops or
leaks.
failure.
A#2 result flag (c‑series)

The sample concentration is too high. Dilute and rerun the sample. For the dilution protocol,
see the assay-specific reagent package insert.
For more information about sample integrity, see the

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Troubleshooting

observe the cuvette washer nozzles for hanging drops or
leaks.
failure.
All ICT results have similar values: Na = 140, K = 4.0, Cl = 100 mmol/L (c‑series)
The ICT aspiration tubing is not connected correctly. Tighten the tubing connections.
aspiration pump.
failure.

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Troubleshooting
Controls out of range (c‑series)

The controls are expired or have exceeded the open vial Open a new control.
stability in the control package insert.
The controls were stored incorrectly or were not stored Open a new control.
according to the storage conditions in the control
package insert.
The controls were reconstituted incorrectly. If the controls require reconstitution, verify the condition
of the diluent, the water, or the pipettors. For information
about quality control reconstitution, see the control
package insert.
A change to the system has occurred: 1. Verify that the bulk solutions were loaded correctly
• New bulk solutions were loaded. if new bulk solutions were recently loaded.
• The component was replaced. 2. Verify that the components were replaced correctly
• The instrument was calibrated. if components were recently replaced.
The sample volume in the sample cup or tube is Place an adequate volume of the sample in the cup or
inadequate. tube. Refer to the assay-specific insert for required
volumes.
Scheduled maintenance is due. Perform and verify that all required maintenance is
completed.
The calibration is not optimal. Recalibrate the assay and repeat the controls.
The cuvette washer is malfunctioning. Contact Customer Service to resolve any hardware
failure.
Depressed concentration: ICT results entire run (c‑series)


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Troubleshooting
Depressed concentration: ICT results single assay (c‑series)

The sample volume in the sample cup or tube is Place an adequate volume of the sample in the cup or
inadequate. tube. Refer to the assay-specific reagent package insert
for required volumes.
Depressed concentration: K+ results single assay (c‑series)

The ICT module is contaminated. Replace the ICT module. Perform Replace the ICT
Depressed concentration: Photometric results entire run (c‑series)

The pipettor aspiration or dispense is insufficient. Perform Pipettors diagnostic procedure 4113 Pipettor
Check (c‑series), page 881.
failure.

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Troubleshooting
Depressed concentration: Photometric results single assay (c‑series)

The sample volume in the sample cup or tube is Place adequate sample in the cup or tube. Refer to the
inadequate. assay-specific reagent package insert for required
volumes.
The water bath temperature is too low. Verify that the temperature is within specifications.
Perform Temperature diagnostic procedure 4301
Temperature Status (c‑series), page 885.
failure.
Elevated concentration: ICT results entire run (c‑series)

Elevated concentration: ICT results single assay (c‑series)

failure.

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Troubleshooting
Elevated concentration: Photometric results single assay (c‑series)

The water bath temperature is too high. Verify that the water bath temperature is within
specifications. Perform Temperature diagnostic
procedure 4301 Temperature Status (c‑series), page
885.
failure.
Erratic results, poor precision: ICT results (c‑series)

Scheduled maintenance is due. Perform all required maintenance.
The sample contains fibrin clots or particulate matter. Examine samples for fibrin or other large particles.
Remove fibrin clots with a clean applicator stick or
centrifuge samples.
The sample was not collected or prepared correctly. • Follow the specimen collection and handling
instructions in the assay-specific reagent package
insert.
• Source another sample if the issue is not resolved.
The ICT module is contaminated. Replace the ICT module. Perform Replace the ICT
The 1 mL syringes in the ICT aspiration pump or the ICT Replace the 1 mL syringes (c‑series), page 958.
Reference Solution pump are leaking.
aspiration pump.

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Troubleshooting

page 952.
aspiration pump.
The black electrical connector for the ICT module is Reseat the black electrical connector to the ICT module.
loose.
The sample or reagent probe is partially obstructed. 1. Perform Fluidics-Wash diagnostic procedure 4208
Probe and Mixer Wash (c‑series), page 883.
2. Replace the appropriate probe. Perform Replace
the sample probe (c‑series), page 922 or Replace
the reagent probes (c‑series), page 925.
The ICT Reference Solution is not performing as Replace the ICT Reference Solution bottle. Perform
expected. Replace bulk solutions and update the inventory, page
579.
The ICT Sample Diluent is not performing as expected. • Replace the ICT Sample Diluent.
• Recalibrate the ICT assays.
specifications.
• The ICT aspiration tubing failed. failure.
• The ICT aspiration pump failed.
• The cuvette washer failed.
• The data acquisition (DAQ) board failed.
• The AC/DC driver board failed.

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Troubleshooting
Erratic results, poor precision: Photometric results (c‑series)

centrifuge samples.
insert.
A syringe seal or an O-ring has failed. Replace the sample syringe O-ring and seal tips 1 and 2
(c‑series) , page 979 or Replace the reagent syringe O-
ring and seal tips 1 and 2 (c‑series), page 972.
The probe tubing connections are loose or leaking. • Tighten the tubing connections by hand.
• Replace the sample probe tubing (c‑series), page
930 or Replace the reagent probe tubing (c‑series),
page 933.
The reagent probe tubing is discolored or contains Replace the reagent probe tubing (c‑series), page 933.
precipitate.
The sample or reagent probe tubing is damaged. Replace the sample probe tubing (c‑series), page 930 or
Replace the reagent probe tubing (c‑series), page 933.
The tubing connection to the sample or reagent syringe Tighten the tubing connections to the sample or reagent
is loose. syringe body. Perform Fluidics-Wash diagnostic
The sample or reagent probe is partially obstructed. 1. Perform Fluidics-Wash diagnostic procedure 4208
Probe and Mixer Wash (c‑series), page 883.
2. Replace the appropriate probe. Perform Replace
the sample probe (c‑series), page 922 or Replace
the reagent probes (c‑series), page 925.
Buildup is present in the sample, the reagent, or one or 1. Inspect all surfaces of the sample, reagent, and
more mixer wash cups. mixer wash cups (including drain openings) for a
buildup of biomass or other contaminants.
2. Perform As-Needed maintenance procedure 5901
Clean Wash Cups (c‑series), page 865.
specifications.

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Troubleshooting

of the pressure of the incoming water. within specifications. See Processing module water and
page 460.
The sample or reagent probe is out of alignment. Perform Pipettors diagnostic procedure 4102 Sample
Pipettor Calibration (c‑series), page 878, 4103 R1
Pipettor Calibration (c‑series), page 878, or 4104 R2
Clean Cuvette Washer Nozzles (c‑series), page
867.
2. Perform As-Needed maintenance procedure 5910
Wash Cuvettes (c‑series), page 867.
for blockage:

Service.
The reagent is not performing as expected. 1. Open a new reagent.
2. If required, recalibrate the new reagent.

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Troubleshooting

The cuvette segment screws are loose. Tighten the cuvette segment screws with a slotted
screwdriver.
The cuvette is damaged. Replace the cuvette segment. Perform Replace the
cuvette segments (c‑series), page 941.
• The mixer malfunctioned. failure.
• The cuvette washer malfunctioned.
• The data acquisition (DAQ) board failed.
• The AC/DC driver board failed.
FLEX result flag (c‑series)

The sample concentration is high. Evaluate the result before it is reported. The sample can
be diluted and rerun. For the dilution protocol, see the
PSHH result flag (c‑series)

The ICT sample that was run before this sample had a Rerun the sample to verify that there was no effect from
concentration outside the linear or defined extreme the previous sample.
range.

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Troubleshooting
Sample results observed problems (i‑series)

Observed problems for sample results include problems that occur with the sample results on
the i‑series processing module.
Controls out of range (i‑series), page 1435
Depressed concentration: Entire run, direct assay, with decreased RLUs (i‑series), page 1436
Depressed concentration: Entire run, indirect assay, with increased RLUs (i‑series), page 1436
Depressed concentration: Single point, direct assay, with decreased RLUs (i‑series), page 1437
Depressed concentration: Single point, indirect assay, with increased RLUs (i‑series), page 1439
Elevated concentration: Entire run, direct assay, with increased RLUs (i‑series), page 1440
Elevated concentration: Entire run, indirect assay, with decreased RLUs (i‑series), page 1440
Elevated concentration: Single point, direct assay, with increased RLUs (i‑series), page 1441
Elevated concentration: Single point, indirect assay, with decreased RLUs (i‑series), page 1442
Erratic assay results (i‑series), page 1444
Controls out of range (i‑series)

Controls are expired or have exceeded the open vial Open new controls.
stability in the control package insert.
Controls were stored incorrectly or were not stored Open new controls.
according to the storage conditions in the control
package insert.
Controls were incorrectly reconstituted. If controls require reconstitution, verify the condition of
the diluent, the water, or the pipettors. For information
about quality control reconstitution, see the control
package insert.
A change to the system has occurred: 1. Verify that the bulk solutions were loaded correctly
• New bulk solutions were loaded. if new bulk solutions were recently loaded.
• A component was replaced. 2. Verify that the components were replaced correctly
• The instrument was calibrated. if components were recently replaced.
volumes.
The wrong quality control lot was used. Use the correct quality control lot for the established
quality control ranges.
Establish new quality control ranges as required.

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Troubleshooting

Depressed concentration: Entire run, direct assay, with decreased RLUs (i‑series)
The pipettor or wash zone assembly tubing connections Tighten the pipettor or wash zone assembly tubing
are loose. connections.
Bubbles are present in the wash buffer tubing. Perform Fluidics-Wash diagnostics procedure 1200
wash zone motor assembly. wash zone probes (i‑series), page 1001.
page 906.
The sample probe is obstructed. • Perform the Flush Wash Buffer option of the
Fluidics-Wash diagnostic procedure 1200 Flush and
Prime Fluidics (i‑series), page 902. Verify that the
pipettors dispense liquid and no leaks or bubbles
are observed in the tubing.
Depressed concentration: Entire run, indirect assay, with increased RLUs (i‑series)
Bubbles are present in the wash buffer tubing. Perform the Flush Wash Buffer option of the Fluidics-
Wash diagnostic procedure 1200 Flush and Prime
Fluidics (i‑series), page 902.

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Troubleshooting

page 906.
Depressed concentration: Single point, direct assay, with decreased RLUs (i‑series)
The reagent was not mixed correctly when it was Upon receipt, gently invert the unopened reagent kit by
received. rotating it over and back for a full 180 degrees, five
times with the green label stripe facing up and then five
times with the green label stripe facing down. This
process ensures that the liquid covers all sides of the
bottles within the cartridges. During reagent shipment,
microparticles can settle on the reagent cartridge
septum.
906.

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Troubleshooting

page 906.
The sample probe is obstructed. • Perform the Flush Wash Buffer option of the
The sample probe is damaged. Replace a sample or reagent pipettor probe (i‑series),
page 998.
volumes.
The pipettor probes are not straight. Perform Pipettors diagnostic procedure 1111 Sample
page 896.
The pipettor probes are not aligned. Perform Pipettors diagnostic procedure 1111 Sample
page 896.
The R1 or the R2 probe is obstructed. • Perform the Flush Wash Buffer option of the
998.
The R1 or the R2 pipettor probe is not positioned Perform the Calibration option of the Pipettors
correctly. diagnostic procedure 1112 R1 Pipettor Check and
Calibration (i‑series), page 895 or 1113 R2 Pipettor

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Troubleshooting

• The syringe assembly or valve is leaking.
• The wash zone assembly is not seated correctly on
the process path.
Depressed concentration: Single point, indirect assay, with increased RLUs (i‑series)
volumes.
The sample cup or tube was not placed correctly in the Reseat the sample cup or tube in the rack.
rack.
The R2 pipettor tubing connections are loose. Tighten the R2 pipettor tubing connections.
The R2 pipettor is not positioned correctly. Perform the Calibration option of the Pipettors
diagnostic procedure 1113 R2 Pipettor Check and
Bubbles are present in the Pre-Trigger Solution or the Perform the Flush Wash Buffer option of the Fluidics-
Trigger Solution tubing. Wash diagnostic procedure 1200 Flush and Prime
Fluidics (i‑series), page 902. Verify that the pipettors
dispense liquid and no leaks or bubbles are observed in
the tubing.
906.
cracked. page 1014.

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Troubleshooting

page 906.
• The R2 syringe assembly or valve is leaking. failure.
the process path.
• The wash zone assembly is leaking.
Elevated concentration: Entire run, direct assay, with increased RLUs (i‑series)
The diluted wash buffer level sensor is cracked. Replace the diluted wash buffer level sensor (i‑series),
page 1014.
page 906.
Elevated concentration: Entire run, indirect assay, with decreased RLUs (i‑series)

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Troubleshooting

page 1014.
page 906.
The probe is obstructed. • Perform the Flush Wash Buffer option of the
Prime Fluidics (i‑series), page 902 and observe that
the pipettors dispense liquid and no leaks or
bubbles are observed in the tubing.
998.
Elevated concentration: Single point, direct assay, with increased RLUs (i‑series)
The reagent was not mixed correctly when it was Upon receipt, gently invert the unopened reagent kit by
received. rotating it over and back for a full 180 degrees, five
times with the green label stripe facing up and then five
times with the green label stripe facing down. This
process ensures that the liquid covers all sides of the
bottles within the cartridges. During reagent shipment,
microparticles can settle on the reagent cartridge
septum.

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Troubleshooting

906.
page 1014.
page 906.
998.
The sample probe is not positioned correctly. Perform Pipettors diagnostic procedure 1111 Sample
The R2 pipettor tubing connections are loose. Tighten the R2 pipettor tubing connections.
The R2 pipettor is not positioned correctly. Perform the Calibration option of the Pipettors
diagnostic procedure 1113 R2 Pipettor Check and
• The R2 syringe assembly or valve is leaking.
Elevated concentration: Single point, indirect assay, with decreased RLUs (i‑series)

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Troubleshooting

906.
page 906.
998.
The sample probe is not positioned correctly. Perform Pipettors diagnostic procedure 1111 Sample
The R1 or R2 probe is obstructed. • Perform Fluidics-Wash diagnostic procedure 1200
998.

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Troubleshooting

• The syringe assembly or valve is leaking.
the process path.
Erratic assay results (i‑series)

906.

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Troubleshooting

page 906.
insert.
inadequate. assay-specific insert for required volumes.
centrifuge samples.
The pipettor probes are not straight. Perform the Probe Straightness option of the Pipettors
Calibration (i‑series), page 895, 1112 R1 Pipettor Check
and Calibration (i‑series), page 895, or 1113 R2 Pipettor
The probe is not positioned correctly. Perform Pipettors diagnostic procedure 1111 Sample
page 896.
The probe is dirty or partially obstructed. Replace the appropriate probe. Perform Replace a
specifications.

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Troubleshooting
User interface (UI) computer observed problems

User interface (UI) computer observed problems include problems that occur with the system
software, the UI computer, or external systems (for example, the host, AbbottLink, and Alinity
PRO).
Assay files on the USB flash drive are missing, page 1446
User interface does not respond, page 1446
Assay files on the USB flash drive are missing

On the Available Files tab of the Install/Uninstall Assays If the assay is located on a USB flash drive, insert the
screen, the USB Flash Drive button was not selected. USB flash drive, and then tap the USB Flash Drive
button.
Assay files were not unzipped after the files were If more than one assay file package is selected from
downloaded from abbottdiagnostics.com. abbottdiagnostics.com, the files are available as a zip
file. The files must be unzipped before they are installed
on the Alinity system.
User interface does not respond

Software error. 1. Open the system control module (SCM) front door.
2. Briefly press the power switch on the user interface
(UI) computer. The software shuts down and the UI
computer powers off.
Printer observed problems

Printer observed problems include problems that may occur with the printer or while printing
reports.

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Troubleshooting
Printer is not displayed in the print location drop-down list, page 1447
Print screen output is configured for the default printer but the print screen is saved to a file, page
1447
A report did not print and the Alinity ci‑series user interface did not generate a message code,
page 1447
When reports are viewed as a PDF, a warning is displayed: "At least one signature has a problem",
page 1447
Printer is not displayed in the print location drop-down list

A printer is not configured. Add a printer, page 195.
A printer is not verified. Verify a printer, page 197.
Print screen output is configured for the default printer but the print screen is saved to a file
A default printer is not configured. Add a printer, page 195.
A report did not print and the Alinity ci‑series user interface did not generate a message
code
A printer error occurred. Certain printer errors are visible only on the printer and
are not communicated to the Alinity ci‑series user
interface. Refer to the printer instructions for use (IFU)
and troubleshoot the error according to the IFU.
When reports are viewed as a PDF, a warning is displayed: "At least one signature has a
problem"
The software used to view a portable document format View the description of the warning in the software. If
(PDF) file cannot identify the digital signature. the PDF file has not been modified since the digital
signature was applied, no further action is required.

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Troubleshooting

A file created on an Abbott instrument has a digital
signature. The digital signature allows an operator who
views the file to know if the file has been modified since
it was created.

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Troubleshooting
Section 10 Miscellaneous corrective action procedures
Miscellaneous corrective action procedures

Corrective action procedures are a series of steps that are recommended to resolve a probable
cause associated with a message code or an observed problem. These procedures are common
to more than one message code or observed problem.
Reagent and sample manager (RSM) corrective action procedure, page 1464
Processing module corrective action procedures

The operator may need to perform corrective action procedures for the processing module when
message codes and observed problems associated with the processing module are diagnosed.
Manually unload a cartridge or rack from the reagent carousel, page 1449
Empty the bulk solution reservoirs (c‑series), page 1452
Empty the diluted wash buffer reservoir (i‑series), page 1460
Enable or disable the ICT module (c‑series), page 1463
Manually unload a cartridge or rack from the reagent carousel

Required materials • #1 Phillips screwdriver
• Cartridge removal tool
Required instrument Processing module: Stopped

status
Perform this procedure to remove a reagent cartridge or onboard vial rack that has a cartridge
status of Load Error.

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Troubleshooting
Miscellaneous corrective action procedures Section 10
1. Turn off all power to the processing module by moving the main power breaker at the rear
of the module to the off position.
2. Lift the front processing center cover to access the reagent supply center.
Figure 168: Manual removal of the reagent carousel cartridge (c‑series)

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Troubleshooting
Figure 169: Manual removal of the reagent carousel cartridge (i‑series)
3. If the reagent positioner is closed, perform the following steps:

a. Insert a #1 Phillips screwdriver into the small hole on the reagent positioner.
b. Firmly press down the screwdriver until the reagent positioner latch releases and moves
slightly to the left of the reagent positioner.
c. Gently push on the reagent positioner base to open the reagent positioner.
NOTE: Do not push on the reagent positioner pocket.
4. If the cartridge or rack is not secured in the reagent carousel, gently remove the cartridge or
rack from the reagent carousel through the opening in the reagent positioner.
5. If the cartridge or rack is secured in the reagent carousel and cannot be removed from the
reagent carousel, perform the following steps:
a. If the reagent transport is down, raise the reagent transport to gain access to the
reagent position spring latch.

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Troubleshooting
b. With a hand on the cartridge or rack, insert the cartridge removal tool into the reagent
carousel and press the reagent position spring latch toward the center of the reagent
carousel to release the cartridge or rack.
IMPORTANT: Before pressing the reagent position spring latch, secure the cartridge or
rack in the reagent position. If the cartridge or rack is not secured in the reagent
position, the cartridge or rack can fall into the reagent carousel, causing the contents of
the cartridge or rack to spill.
c. Remove the cartridge or rack.
7. Power on the processing module.
9. Initiate sample processing for the RSM.
10. Load the cartridge or rack on the RSM.
NOTE: The cartridge or rack must be loaded on the system to reconcile the software
inventory. If the cartridge will not load on the system or is unavailable to load on the system,
contact Customer Service to delete the cartridge.
Empty the bulk solution reservoirs (c‑series)

• Purified water

status
Perform this procedure to remove the Alkaline Wash [1], the Acid Wash [2], or the ICT
Reference Solution [3] from the bulk solution reservoir when the bulk solution expires.

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Troubleshooting
level sensors, empty one reservoir bottle at a time.

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Troubleshooting
3. Use absorbent towels to absorb any spills.

7. Remove the bulk solution reservoir from the reservoir bottle tray.
8. Empty the reservoir and rinse it with purified water.
9. Replace the reservoir in the reservoir bottle tray.

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Troubleshooting

12. Connect the tubing from the bulk solution transfer pump (labeled IN) to the input connector
(labeled with an arrow that points toward the connector) on the bulk solution level sensor.
13. Connect the tubing from the syringe pump (labeled OUT) to the output connector (labeled
with an arrow that points away from the connector) on the bulk solution level sensor.
16. Confirm that a full bottle of the appropriate bulk solution is located on the bulk solution door.
Confirm that the bulk solution is within the expiration date on the bulk solution bottle label. If
necessary, replace the bulk solution and update the inventory.
17. Start the processing module to initiate the transfer of bulk solution.
18. While the system performs the bulk solution transfer, inspect the tubing and connections of
the bulk solution level sensor for drips and leaks. If drips or leaks are observed, repeat the
installation procedure.
Flush Bulk Solutions (c‑series), page 883.

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Troubleshooting
door.
Empty the bulk solution reservoirs (i‑series)

• Purified water

status
Perform this procedure to remove the Concentrated Wash Buffer [1], the Trigger Solution [2], or
the Pre-Trigger Solution [3] from the bulk solution reservoir when the bulk solution expires.

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Troubleshooting
level sensors, empty one reservoir bottle at a time.

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Troubleshooting

5. Remove the bulk solution reservoir from the reservoir bottle tray.
7. Remove the bulk solution level sensor from the reservoir. Set aside the level sensor on a
clean absorbent towel.
8. Empty the reservoir and rinse it multiple times with purified water. Drain the excess liquid
from the reservoir.

80000071-105 - 2018-09-10
Troubleshooting

11. Replace the reservoir in the reservoir bottle tray.
14. Confirm that both tubing connectors are tightened completely.
16. Confirm that a full bottle of the appropriate bulk solution is located on the bulk solution door.
Confirm that the bulk solution is within the expiration date on the bulk solution bottle label. If
necessary, replace the bulk solution and update the inventory.
17. Start the processing module to initiate the transfer of bulk solution.
18. While the system performs the bulk solution transfer, inspect the tubing and connections of
the bulk solution level sensor for drips and leaks. If drips or leaks are observed, repeat the
installation procedure.

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Troubleshooting
Flush and Prime Fluidics (i‑series), page 902 twice for the appropriate bulk solution.
Perform one of the following procedure options:
– Flush Pre-Trigger and Trigger
– Prime Dilution Assembly
door.
1401, page 1161
1402, page 1161
1403, page 1162
Empty the diluted wash buffer reservoir (i‑series)

• Purified water
• Lock ring release tool

status
Perform this procedure to remove the diluted wash buffer from the diluted wash buffer reservoir
when the wash buffer expires.
1. Remove the rear fluidics panel and pull out the pump drawer.
NOTE: Use caution when handling the diluted wash buffer level sensor. Avoid applying
stress on the wiring and connector.

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Troubleshooting
3. Use the lock ring release tool to press the lock ring against the diluted wash buffer level
sensor and pull the tubing straight out of the level sensor.
4. Repeat step 3, page 1461 to remove the remaining tubing.
5. Disconnect the electrical connector from the diluted wash buffer level sensor.
NOTE: To gain access to the electrical connector, lift the right side of the dilution assembly
tray and rotate it on its hinges.
6. Remove the diluted wash buffer reservoir from the pump drawer.
7. Unscrew the diluted wash buffer level sensor cap.
8. Remove the diluted wash buffer level sensor from the reservoir. Set aside the level sensor
on a clean absorbent towel.
9. Empty the reservoir and rinse it multiple times with purified water. Drain the excess liquid
from the reservoir.
10. Place the diluted wash buffer level sensor into the container.

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Troubleshooting
11. Tighten the diluted wash buffer level sensor cap.

12. Replace the reservoir in the pump drawer.
13. Connect the tubing from the buffer waste valve (located at the top of the dilution assembly
tray) to the input connector (labeled with an arrow that points toward the connector) on the
diluted wash buffer level sensor.
15. Connect the tubing from the manifold in the pump drawer to the output connector (labeled
with an arrow that points away from the connector) on the diluted wash buffer level sensor.
17. Slightly pull the tubing connector to confirm that it is connected completely.
18. Connect the electrical connector of the diluted wash buffer level sensor.
19. Rotate the dilution assembly tray downward.
20. Start the processing module to initiate the dilution of the Concentrated Wash Buffer.

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Troubleshooting
21. While the diluted wash buffer reservoir is filled with diluted wash buffer, inspect the tubing
and connections of the diluted wash buffer level sensor for drips and leaks. If drips or leaks
are observed, repeat the installation procedure.
Flush and Prime Fluidics (i‑series), page 902, Flush Wash Buffer option.
While performing the flush, inspect the tubing and connections of the diluted wash buffer
level sensor for drips and leaks. If drips or leaks are observed, repeat the installation
procedure.
23. Slide the pump drawer into the rear fluidics area and replace the rear fluidics panel.
Enable or disable the ICT module (c‑series)

status
Perform this procedure to enable or disable the ICT module.

3. Under Module Information on the Modules screen, tap a c‑series module in the drop-down
list.
4. In the Installed area under ICT Module, tap one of the following options:
– Tap Yes to enable the ICT module.
– Tap No to disable the ICT module.

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Troubleshooting
Reagent and sample manager (RSM) corrective action procedure

The operator may need to perform the corrective action procedure for the reagent and sample
manager (RSM) when message codes and observed problems associated with the RSM are
diagnosed.
Remove racks from the sample positioners, page 1464
Remove racks from the sample positioners

status
Perform this procedure to remove sample and vial racks from the inner and outer sample
positioners after one of the following situations occurs:
• Power to the processing module or the reagent and sample manager (RSM) is interrupted.
• An error has caused the instrument status of the processing module or the RSM to transition
unexpectedly to Stopped.
• A maintenance procedure or a diagnostic procedure has caused the instrument status of the
processing module or the RSM to transition unexpectedly to Stopped.
1. Lift the front processing center cover.

2. Observe the inner sample positioner to determine if a rack is present.

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Troubleshooting
3. Gently push the sample positioner pocket to the front of the processing module until the
pocket touches the end of the lane and the pocket latch is pressed in.
4. Remove the rack.
5. Repeat steps 2, page 1464 through 4, page 1465 for the outer sample positioner.
6. Start the RSM to home the sample positioner pockets.
Reagent and sample manager (RSM) corrective action procedure, page 1464
User interface (UI) computer corrective action procedures

The operator may need to perform corrective action procedures for the user interface (UI)
computer when message codes and observed problems associated with the UI computer and the
host interface are diagnosed.

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Troubleshooting
Verify the LAS communication, page 1467
Enable or disable the host connection, page 531
Cancel pending transmissions, page 531
Verify the HL7 communication

Prerequisite • The host interface must be configured for HL7
communication.
• HL7 communication settings must be configured.
• The message queue must be empty.

status
Perform this procedure to verify the HL7 communication.

3. On the Computer tab of the Configure screen, tap HL7 Communication.
4. On the HL7 Communication screen, tap Save/Test.
5. In the Connection Tests flyout, verify the test results that are displayed:
If all connection tests No additional action is required.

passed
If a connection test – Verify that the host interface option is configured for
failed or was not HL7 communication.
performed
– Verify that the HL7 communication settings are
accurate.
– Verify that the Ethernet cable from the user interface
computer to the host interface is connected.

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Troubleshooting
6. To return to the HL7 Communication screen, tap Done.
Verify the LAS communication

Prerequisite • The laboratory automation system (LAS) interface
channel settings must be configured.
• The LAS configuration must be enabled.
• The LAS connection status must be enabled.

status
Perform this procedure to verify the LAS communication.

3. On the Computer tab of the Configure screen, tap LAS Communication.
4. On the LAS Communication screen, tap Save/Test.

passed
If a connection test – Verify that the On option is enabled for LAS
failed or was not configuration.
performed
– Verify that the LAS communication settings are
accurate.
– Verify that the Ethernet cable from the user interface
computer to the LAS interface is connected.
6. To return to the LAS Communication screen, tap Done.

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Troubleshooting
Configure LAS communication settings, page 235
Verify the ASTM communication

Prerequisite • The host interface must be configured for ASTM
communication.
• ASTM communication settings must be configured.
• The message queue must be empty.

status
Perform this procedure to verify the ASTM communication.

3. On the Computer tab of the Configure screen, tap ASTM Communication.
4. On the ASTM Communication screen, tap Save/Test.

passed
If a connection test – Verify that the host interface option is configured for
failed or was not ASTM communication.
performed
– Verify that the ASTM communication settings are
accurate.
– Verify that the network connection between the system
and the host is established.
6. To return to the ASTM Communication screen, tap Done.

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Troubleshooting
Reseat network cables to the system control module (SCM)

Perform this procedure to reseat the network cables to the system control module (SCM) when
communication time-out errors occur or when suggested by the corrective action of an error
message.
1. Power off the user interface (UI) computer.
2. Locate the network cables at the rear of the SCM.
3. Disconnect and then reconnect the network cables.
NOTE: Do not proceed to the next step until the UI computer displays the Log On screen.
5. Cycle power to the processing module and the reagent and sample manager.
Power off the user interface (UI) computer, page 488
Network connectors, page 64

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Troubleshooting
NOTES

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Appendix A Verification of assay claims
Introduction
Verification procedures are performed to verify Alinity ci‑series assay claims. These procedures
are used only to verify that a method operates according to the manufacturer's claims. The
procedures are not intended to establish or validate the analytical performance of the method.
Not all procedures are required for each assay. For the manufacturer's claims that are specific
to the assay, see the assay documentation.
Limit of blank, limit of detection, and limit of quantitation, page 1472
Precision, page 1489
Perform a calibration verification, page 1497
Verify the linearity, page 1501
Measuring interval, page 1505
Verify an automated dilution, page 1506
Method comparison, page 1511
Verify the reference range (expected values), page 1525
page 1564

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Verification of assay claims
Limit of blank, limit of detection, and limit of quantitation Appendix A
Limit of blank, limit of detection, and limit of

quantitation
Limit of blank (LoB), limit of detection (LoD), and limit of quantitation (LoQ) represent the
smallest concentration of a measurand that can be measured reliably by an analytical
procedure. The measure of analytical sensitivity correlates to LoB, while the functional sensitivity
data is considered comparable to LoQ values.
Procedures for LoB, LoD, and LoQ are developed from Clinical and Laboratory Standards
Institute (CLSI) document EP17-A2 and provide a recommended study design and statistical
analysis plan to verify that the manufacturer's claims for LoB, LoD, and LoQ can be met. The
procedures are used only to verify that a method operates according to the manufacturer's
claims. The procedures are not intended to establish or validate the analytical performance of
the method. When a laboratory has successfully completed this study, the laboratory has verified
that the method operates according to the manufacturer's claims for LoB, LoD, and LoQ.
For LoB, LoD, and LoQ data for assays on the Alinity ci‑series, see the assay documentation.
Verification of assay claims, page 1471
Verify a limit of blank (LoB) claim, page 1472
Verify a limit of detection (LoD) claim, page 1475
Limit of quantitation (LoQ), page 1478
Verify a limit of blank (LoB) claim

The following prerequisites are the minimum experimental design requirements:
• Reagent lot
• Instrument system
• 3 days
• Two blank samples (zero concentration levels)
NOTE: Ensure that the sample volume is adequate to test each sample a minimum of 10
times.
• Two replicates per sample per day
• Twenty replicates across all samples and days
NOTE: To yield the minimum requirement of 20 replicates, test the samples for 5 days. Based on
the available resources and time, the study design can be modified by increasing the number of
replicates or the number of samples such that a minimum of 20 measurable results are
generated across all samples and days.

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Appendix A Limit of blank, limit of detection, and limit of quantitation
Perform this procedure to verify a limit of blank (LoB) claim based on the definition from Clinical
and Laboratory Standards Institute (CLSI) document EP17-A2, which uses proportions of false
positives that are less than 5%.
1. Test each sample in duplicate one time each day for 5 days.
2. Count the number of replicates that are greater than the LoB claim.
NOTE: For LoB data for assays on the Alinity ci‑series, see the assay documentation.
For a sample size of 20 measurements, the LoB claim is verified if three or fewer replicates are
greater than the claim.
Limit of blank (LoB) worksheet (c‑series), page 1473
Limit of blank (LoB) worksheet (i‑series), page 1474
Limit of blank (LoB) worksheet (c‑series)

Date: Analyte:
Instrument: Serial number:
Product Lot number Expiration date

Reagent
Calibrators
Controls
Acid Wash
Alkaline Wash
Diluent
Data
Replicate Concentration Replicate Concentration

1 11
2 12
3 13
4 14
5 15

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6 16
7 17
8 18
9 19
10 20
Reference values
LoB claim measurand concentration:
For LoB data for assays on the system, see the assay documentation.
Results
Number of values > Manufacturer's LoB claim:
Comments:
Technologist: Date:
Reviewed by: Date:
Limit of blank (LoB) worksheet (i‑series)

Date: Analyte:

Reagent
Calibrators
Controls
Trigger Solution
Wash buffer
Reaction vessel
Diluent
Data

1 11
2 12

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3 13
4 14
5 15
6 16
7 17
8 18
9 19
10 20
Reference values
For LoB data for assays on the system, see the assay documentation.
Results
Number of values > Manufacturer's LoB claim:
Comments:
Technologist: Date:
Reviewed by: Date:
Verify a limit of detection (LoD) claim

The associated limit of blank (LoB) claim is necessary to verify the limit of detection (LoD) claim.
Verify the LoB claim before verifying the LoD claim.
• Reagent lot
• 3 days
• Two samples at the LoD claim measurand concentration
NOTE: Samples can be spiked or can be diluted to obtain the correct concentration if the
spiked or diluted samples perform similarly to unaffected patient samples.
times.

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Perform this procedure to verify the LoD claim based on the definition from Clinical and
Laboratory Standards Institute (CLSI) document EP17-A2, which uses proportions of false
positives that are less than 5%.
2. Count the number of replicates that are less than the LoB claim.
NOTE: For LoB data for assays on the Alinity ci‑series, see the assay documentation.
For a sample size of 20 measurements, the LoD claim is verified if three or fewer replicates are
less than the LoB claim.
Limit of detection (LoD) worksheet (c‑series), page 1476
Limit of detection (LoD) worksheet (i‑series), page 1477
Limit of detection (LoD) worksheet (c‑series)

Date: Analyte:

Reagent
Calibrators
Controls
Acid Wash
Alkaline Wash
Diluent
Data

1 11
2 12

80000071-105 - 2018-09-10

3 13
4 14
5 15
6 16
7 17
8 18
9 19
10 20
Reference values
LoD claim measurand concentration:
For LoB and LoD data for assays on the system, see the assay documentation.
Results
Number of values < Manufacturer's LoB claim:
Comments:
Technologist: Date:
Reviewed by: Date:
Limit of detection (LoD) worksheet (i‑series)

Date: Analyte:

Reagent
Calibrators
Controls
Trigger Solution
Wash buffer
Reaction vessel
Diluent
Data

80000071-105 - 2018-09-10

1 11
2 12
3 13
4 14
5 15
6 16
7 17
8 18
9 19
10 20
Reference values
LoD claim measurand concentration:
For LoB and LoD data for assays on the system, see the assay documentation.
Results
Number of values < Manufacturer's LoB claim:
Comments:
Technologist: Date:
Reviewed by: Date:
Limit of quantitation (LoQ)

Limit of quantitation (LoQ) is defined in one of the following ways:
• The lowest concentration at which the total allowable error is met
• The lowest concentration at which precision and bias specifications are met independently
• The lowest concentration at which a given precision is met
To determine the definition and specifications that are used to establish the LoQ for assays on
the Alinity ci‑series, see the assay documentation.
Verify a limit of quantitation (LoQ) claim based on the total allowable error method, page 1479
Verify a limit of quantitation (LoQ) claim based on the precision and bias method, page 1483

80000071-105 - 2018-09-10
Limit of quantitation (LoQ) claim: Precision method, page 1488
Verify a limit of quantitation (LoQ) claim based on the total allowable error method
• Reagent lot
• 3 days
• Two samples with known values at the limit of quantitation (LoQ) claim measurand
concentration
NOTE: Concentration values can be obtained from external assignment (for example, a
reference standard) or can be determined by testing with a reference method. Samples can
be spiked or can be diluted to obtain the correct concentration.
times.
Perform this procedure to verify the LoQ claim when the claim is defined as the lowest amount
of analyte in a sample that can be quantitatively determined based on the total allowable error or
based on independent precision and bias specifications. This procedure is based on
recommendations from Clinical and Laboratory Standards Institute (CLSI) document EP17-A2.
2. Obtain the total allowable error (TEa) goal for the assay from the assay documentation.
3. Calculate the tolerance interval around the target concentration for the sample by using one
of the following equations:
– If TEa is represented as a percentage:
Tolerance interval = A - [A x (B ÷ 100)] to A + [A x (B ÷ 100)]
Where:
A LoQ target concentration
B TEa

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For example, if the target concentration is 5 ng/mL and the TEa is 20%, the tolerance
interval is 4 ng/mL to 6 ng/mL:
5 - [5 x (20 ÷ 100)] = 4 to 5 + [5 x (20 ÷ 100)] = 6
– If TEa is represented as an absolute number:
Tolerance interval = A - B to A + B
Where:
B TEa
For example, if the target concentration is 8 mg/dL and the TEa is 0.5 mg/dL, the
tolerance interval is 7.5 mg/dL to 8.5 mg/dL:
8 - 0.5 = 7.5 to 8 + 0.5 = 8.5
4. Compare each replicate to the tolerance interval and count the number of measurements
that fall outside the interval.
NOTE: For LoQ data for assays on the Alinity ci‑series, see the assay documentation.
For a sample size of 20 measurements, the LoQ claim is verified if three or fewer replicates fall
outside the tolerance interval.
Limit of quantitation (LoQ): Total allowable error method worksheet (c‑series), page 1480
Limit of quantitation (LoQ): Total allowable error method worksheet (i‑series), page 1482
Limit of quantitation (LoQ): Total allowable error method worksheet (c‑series)

Date: Analyte:

Reagent
Calibrators
Controls
Acid Wash
Alkaline Wash
Diluent
Data

80000071-105 - 2018-09-10

1 11
2 12
3 13
4 14
5 15
6 16
7 17
8 18
9 19
10 20
Reference values
LoQ claim measurand concentration:
Total allowable error (TEa) claim:
For LoQ and TEa data for assays on the system, see the assay documentation.
Calculations
TEa represented as a percentage:
Tolerance interval = LoQ - [LoQ x (TEa ÷ 100)] to LoQ + [LoQ x (TEa ÷ 100)]
Lower limit:
− × 100
=
Upper limit:
+ × 100
=
TEa represented as an absolute number:

Lower limit:
− =
Upper limit:
+ =
Results
Tolerance interval:
Number of values that fall outside the tolerance interval:
Comments:
Technologist: Date:
Reviewed by: Date:

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Limit of quantitation (LoQ): Total allowable error method worksheet (i‑series)

Date: Analyte:

Reagent
Calibrators
Controls
Trigger Solution
Wash buffer
Reaction vessel
Diluent
Data

1 11
2 12
3 13
4 14
5 15
6 16
7 17
8 18
9 19
10 20
Reference values
Total allowable error (TEa) claim:
For LoQ and TEa data for assays on the system, see the assay documentation.
Calculations

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Lower limit:
− × 100
=
Upper limit:
+ × 100
=

Lower limit:
− =
Upper limit:
+ =
Comments:
Technologist: Date:
Reviewed by: Date:
Verify a limit of quantitation (LoQ) claim based on the precision and bias method
• Reagent lot
• 3 days
• Two samples with known values at the limit of quantitation (LoQ) claim measurand
concentration
NOTE: Concentration values can be obtained from external assignment (for example, a
reference standard) or can be determined by testing with a reference method. Samples can
be spiked or can be diluted to obtain the correct concentration.
times.
Perform this procedure to verify the LoQ claim when the claim is defined as the lowest amount
of analyte in a sample that can be quantitatively determined based on independent precision and

80000071-105 - 2018-09-10
bias specifications. This procedure is based on recommendations from Clinical and Laboratory
Standards Institute (CLSI) document EP17-A2.
2. Calculate the total allowable error (TEa) goal for the assay:
TEa = Precision x 2 + Bias
NOTE: Obtain the maximum allowable precision and bias values for assays from the assay
documentation.
3. Calculate the tolerance interval around the target concentration for the sample by using one
of the following equations:
– If TEa is represented as a percentage:
Tolerance interval = A - [A x (B ÷ 100)] to A + [A x (B ÷ 100)]
Where:
B TEa
For example, if the target concentration is 5 ng/mL and the TEa is 20%, the tolerance
interval is 4 ng/mL to 6 ng/mL:
5 - [5 x (20 ÷ 100)] = 4 to 5 + [5 x (20 ÷ 100)] = 6
– If TEa is represented as an absolute number:
Where:
B TEa
For example, if the target concentration is 8 mg/dL and the TEa is 0.5 mg/dL, the
tolerance interval is 7.5 mg/dL to 8.5 mg/dL:
8 - 0.5 = 7.5 to 8 + 0.5 = 8.5
4. Compare each replicate to the tolerance interval and count the number of measurements
that fall outside the interval.
For a sample size of 20 measurements, the LoQ claim is verified if three or fewer replicates fall
outside the tolerance interval.

80000071-105 - 2018-09-10
Limit of quantitation (LoQ): Precision and bias method worksheet (c‑series), page 1485
Limit of quantitation (LoQ): Precision and bias method worksheet (i‑series), page 1486
Limit of quantitation (LoQ): Precision and bias method worksheet (c‑series)

Date: Analyte:

Reagent
Calibrators
Controls
Acid Wash
Alkaline Wash
Diluent
Data

1 11
2 12
3 13
4 14
5 15
6 16
7 17
8 18
9 19
10 20
Reference values
Precision claim:
Bias claim:
For LoQ, precision, and bias data for assays on the system, see the assay documentation.
Calculations

80000071-105 - 2018-09-10

× 2 + =
Lower limit:
− × 100
=
Upper limit:
+ × 100
=

Lower limit:
− =
Upper limit:
+ =
Results
TEa:
Tolerance interval:
Comments:
Technologist: Date:
Reviewed by: Date:
Limit of quantitation (LoQ): Precision and bias method worksheet (i‑series)

Date: Analyte:

Reagent
Calibrators
Controls
Trigger Solution
Wash buffer

80000071-105 - 2018-09-10

Reaction vessel
Diluent
Data

1 11
2 12
3 13
4 14
5 15
6 16
7 17
8 18
9 19
10 20
Reference values
Precision claim:
Bias claim:
For LoQ, precision, and bias data for assays on the system, see the assay documentation.
Calculations
× 2 + =
Lower limit:
− × 100
=
Upper limit:
+ × 100
=

Lower limit:
− =
Upper limit:
+ =

80000071-105 - 2018-09-10
Results
TEa:
Tolerance interval:
Comments:
Technologist: Date:
Reviewed by: Date:
Limit of quantitation (LoQ) claim: Precision method

Limit of quantitation (LoQ) claims that are based only on a precision goal can be verified by
using the procedure to verify the precision at the LoQ claim measurand concentration.
Verify the precision, page 1489

80000071-105 - 2018-09-10
Appendix A Precision
Precision
Precision indicates how well an assay or a system provides the same result when a given
sample is tested repeatedly and over time. Specifically, within-run (repeatability) and within-
laboratory (total) precision are used to evaluate the performance of the assay or system. Within-
run precision provides a best-case estimate of the expected performance since the opportunity
for conditions to change during the course of the run is minimal. Within-laboratory precision is a
more realistic assessment of the performance because it incorporates performance over time.
The procedure to determine the precision is developed from Clinical and Laboratory Standards
Institute (CLSI) document EP15-A2. The procedure provides a recommended study design and
statistical analysis plan to verify that the manufacturer's claims for within-laboratory precision
can be met. Because the study design does not provide an adequate statistical basis to reject
the claims, the procedure is used only to verify that a method operates according to the
manufacturer's claims. The procedure is not intended to establish or validate the analytical
performance of the method. When a laboratory has successfully completed the study, the
laboratory has verified that the method operates according to the manufacturer's claims for
within-laboratory precision.
For precision data for assays on the Alinity ci‑series, see the assay documentation.
Evaluate the precision data, page 1490
Calculate a precision verification value, page 1492
Precision worksheet (c‑series), page 1493
Precision worksheet (i‑series), page 1495
Verify the precision

Required materials Two samples at different concentration levels
NOTE: The concentration levels need to be at or near the
medical decision points for the assay.
NOTE: Ensure that the sample volume is adequate to test
each sample 15 times.
Perform this procedure to verify the precision for an assay on the Alinity ci‑series.
1. Test each sample in triplicate one time each day for 5 days.
2. Test quality control (QC) samples in each day's run.

80000071-105 - 2018-09-10
Precision Appendix A
3. If quality control does not meet the acceptance criteria:

a. Reject the run.
b. Discard the data.
c. Correct the problem.
d. Retest the QC samples in an additional run.
After this procedure is completed, evaluate the precision data.
Limit of quantitation (LoQ) claim: Precision method, page 1488
Evaluate the precision data

Required materials Two precision worksheets
Perform this procedure to evaluate the data that is generated from the following procedures:
• Verify the precision.
• Calculate a precision verification value.
NOTE: Use a separate worksheet for each sample concentration level. The statistical
calculations in this procedure and on the associated worksheet are from Clinical and Laboratory
Standards Institute (CLSI) document EP15-A2. These calculations are valid only according to the
conditions that are specified. As an alternative to performing the calculations manually, a
laboratory can use a software package that is designed to perform the calculations.
1. For each run, enter three replicate values (Xd1, Xd2, and Xd3) on lines 1 through 3 of the
worksheet.
d = The number that corresponds to the run day
2. Calculate the mean (Xd) of the three replicates and enter the value on line 4.
3. For each replicate, subtract the mean value from the replicate value:
a. Enter (Xd1 - Xd) on line 5.
b. Enter (Xd2 - Xd) on line 7.
c. Enter (Xd3 - Xd) on line 9.
4. Square the values that were obtained in step 3, page 1490:
a. Enter (Xd1 - Xd)2 on line 6.
b. Enter (Xd2 - Xd)2 on line 8.

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c. Enter (Xd3 - Xd)2 on line 10.

5. For each run, add the values that were obtained in step 4, page 1490 and enter the sum on
line 11.
6. Calculate the average variance (standard deviation squared) of the run (SD2run av):
– Add all of the values on line 11. If 5 runs were performed, divide the sum by 10 and
enter the new value on line 12.
7. Calculate the grand mean (=
x ):
– Add all of the mean values on line 4. If 5 runs were performed, divide the sum by 5 and
– Add all of the mean values on line 4. If 7 runs were performed, divide the sum by 7 and
8. For each run, subtract the grand mean value (line 13) from the mean value (line 4) and
enter (Xd - =
x ) on line 14.
9. For each run, square the value on line 14 and enter (Xd - =
x )2 on line 15.
10. Calculate the square root of the SD2run av and enter the value on line 16.
The value is the estimated repeatability standard deviation (sr).
11. Calculate the between-run variance term (sb2):
12. Calculate the standard deviation of the within-laboratory (total) precision and enter the value
on line 18:
2
sl = 3
× s 2r + s 2b
sr = The value on line 16

sb2 = The value on line 17
13. Compare the within-laboratory standard deviation (sl) from line 18 to the manufacturer’s
claim for within-laboratory standard deviation.
NOTE: If the manufacturer's within-laboratory precision claim is provided in terms of the
percent coefficient of variation (%CV), use the following equation to convert the %CV to a
standard deviation (SD) at the average concentration for all results for the material that is
tested:
Manufacturer's within-laboratory SD = Manufacturer's claim within-laboratory %CV x =
x
(grand mean on line 13)

80000071-105 - 2018-09-10
– If the calculated value is less than the claim value, the procedure demonstrates that the
precision data is consistent with the claim.
– If the calculated value is greater than the claim value, calculate a precision verification
value to determine whether the difference is statistically significant.
Calculate a precision verification value

Required materials The precision worksheet that contains the evaluated precision
data
When the calculated within-laboratory standard deviation exceeds the manufacturer's claim,
perform this procedure to determine whether the difference is statistically significant.
1. Calculate the effective degrees of freedom (T):
– For a procedure that requires 5 days and tests three replicates per day, use the
following equation:
2 2
2s 2r + ( 3s b )
T =
0.4s 4r + 2.25 ( s 2b ) 2
– For a procedure that requires 7 days and tests three replicates per day, use the
following equation:
2
2s 2r + ( 3s b ) 2
T =
0.286s 4r + 1.5 ( s 2b ) 2
2. Calculate the verification value:

– For a precision verification that requires 5 days and uses three replicates and two
concentration levels per day, use the following equation:
σ l × 4.53
V = T
Where:
V Verification value
σl Manufacturer's within-laboratory (total) precision claim

80000071-105 - 2018-09-10
T Degrees of freedom from step 1, page 1492
– For a precision verification that requires 7 days and uses three replicates and two
concentration levels per day, use the following equation:
σ l × 5.11
V = T
Where:
V Verification value
σl Manufacturer's within-laboratory (total) precision claim
T Degrees of freedom from step 1, page 1492
3. Compare the estimated within-laboratory standard deviation (sl) from line 18 of the precision
worksheet to the verification value:
– If sl is less than or equal to the verification value, the precision data is consistent with
the claim and is verified.
– If sl is greater than the verification value and the evaluated precision data was
generated with a precision verification procedure that requires 5 days, perform two
additional data runs. Recalculate all statistics by repeating the procedure to evaluate
the precision data.
– If sl is greater than the verification value and the evaluated precision data was
generated with a precision verification procedure that requires 7 days, troubleshoot to
identify the cause of the imprecision. When the imprecision is resolved, repeat the
procedure to verify the precision.
Precision worksheet (c‑series)

Date: Analyte:

Reagent
Calibrators

80000071-105 - 2018-09-10

Controls
Acid Wash
Alkaline Wash
Diluent
Line Run 1 Run 2 Run 3 Run 4 Run 5 Optional run Optional run
(d=1) (d=2) (d=3) (d=4) (d=5) 6 (d=6) 7 (d=7)
Operator
1 Replicate 1 (Xd1)
2 Replicate 2 (Xd2)
3 Replicate 3 (Xd3)
4 Mean of run (Xd)
5 (Xd1 - Xd)
6 (Xd1 - Xd)2
7 (Xd2 - Xd)
8 (Xd2 - Xd)2
9 (Xd3 - Xd)
10 (Xd3 - Xd)2
11 Total of lines 6, 8, and 10
12 SD2run av
13 Grand mean (=
x)
14 =
(X - x )
d
15 (Xd - =
x )2
16 sr = √SD2run av
17 sb2
18 2
sl = 3
× s 2r + s 2b
Line Verification value calculations

1 T (5 days)
2 T (7 days)
3 Verification value (5 days)
Comments:
Technologist: Date:

80000071-105 - 2018-09-10
Reviewed by: Date:
Precision worksheet (i‑series)

Date: Analyte:

Reagent
Calibrators
Controls
Trigger Solution
Wash buffer
Reaction vessel
Diluent
(d=1) (d=2) (d=3) (d=4) (d=5) 6 (d=6) 7 (d=7)
Operator
1 Replicate 1 (Xd1)
2 Replicate 2 (Xd2)
3 Replicate 3 (Xd3)
4 Mean of run (Xd)
5 (Xd1 - Xd)
6 (Xd1 - Xd)2
7 (Xd2 - Xd)
8 (Xd2 - Xd)2
9 (Xd3 - Xd)
10 (Xd3 - Xd)2
11 Total of lines 6, 8, and 10
12 SD2run av
13 Grand mean (=
x)

80000071-105 - 2018-09-10
(d=1) (d=2) (d=3) (d=4) (d=5) 6 (d=6) 7 (d=7)
14 (Xd - =
x)
15 (X - =
d x )2
16 sr = √SD2run av
17 sb2
18 2
sl = 3
× s 2r + s 2b
Line Verification value calculations

1 T (5 days)
2 T (7 days)
Comments:
Technologist: Date:
Reviewed by: Date:

80000071-105 - 2018-09-10
Appendix A Perform a calibration verification
Perform a calibration verification

• Reagent lot
• Sample at or near the lower limit of the measuring interval claim
• Sample with a concentration level that is near the midpoint or the clinically relevant area of
the assay range
• Sample with a concentration level that is within or below the upper limit of the measuring
interval claim
NOTE: If the sample concentration is above the high linearity, dilute the sample accordingly
to bring the concentration within the measuring interval.
Perform this procedure to confirm that the Alinity ci‑series accurately measures samples within
the tolerance limits that are established.
This evaluation is based on the U.S. Clinical Laboratory Improvement Act (CLIA), 42 CFR 493.2;
and the laboratory quality management protocol of the College of American Pathologists (CAP),
Calibration Verification/Linearity Surveys--User's Guide 2009.
1. Calibrate the assay.

2. Test each sample in triplicate.
3. Determine the tolerance limits at the target concentration for each sample:
– Half of the goal for total allowable error (TEa)
– Additional magnitude of error that the laboratory considers to be appropriate
For example, if the target concentration is 10 mg/dL and the TEa is 20%, the tolerance limit
around the target concentration is 10%. The lower tolerance limit is 9 mg/dL and the upper
tolerance limit is 11 mg/dL.
4. For each sample, calculate the percent difference (%D) for each measurement (Xi) with
respect to the target concentration (µ):
Xi − μ
%D = μ
× 100
NOTE: The target concentration (µ) is the concentration of the reference method against
which the assay is calibrated or the value-assigned concentration.
5. Plot the %D versus the target concentration for each sample.
6. Plot the low and high tolerance limits versus the target concentration for each sample.
7. Join the points to generate the tolerance band.

80000071-105 - 2018-09-10
Perform a calibration verification Appendix A
The calibration verification evaluation is verified if the %D for each sample is within the tolerance
limits.
Calibration verification worksheet (c‑series), page 1498
Calibration verification worksheet (i‑series), page 1499
Calibration verification worksheet (c‑series)

Date: Analyte:

Reagent
Calibrators
Controls
Acid Wash
Alkaline Wash
Diluent
Data
Sample Target Measured %Difference Lower tolerance Upper tolerance

concentration concentration limit limit
X1
X1
X1
X2
X2
X2
X3
X3
X3
Calculations
For each sample, calculate the percent difference (%D) for each measurement (Xi) with respect to the target
concentration (μ):
Xi − μ
%D = μ
× 100

80000071-105 - 2018-09-10
Appendix A Perform a calibration verification
Comments:
Technologist: Date:
Reviewed by: Date:
Calibration verification worksheet (i‑series)

Date: Analyte:

Reagent
Calibrators
Controls
Trigger Solution
Wash buffer
Reaction vessel
Diluent
Data
Sample Target Measured %Difference Lower tolerance Upper tolerance

concentration concentration limit limit
X1
X1
X1
X2
X2
X2
X3
X3
X3
Calculations
For each sample, calculate the percent difference (%D) for each measurement (Xi) with respect to the target
concentration (μ):

80000071-105 - 2018-09-10
Perform a calibration verification Appendix A
Xi − μ
%D = μ
× 100
Comments:
Technologist: Date:
Reviewed by: Date:

80000071-105 - 2018-09-10
Appendix A Verify the linearity
Verify the linearity

• Reagent lot
• Low sample pool with a concentration within 10% greater than the lower limit of the
measuring interval claim
• High sample pool with a concentration within 10% less than the upper limit of the measuring
interval claim
NOTE: Commercial linearity material can be used instead of the low and high sample pools.
A linearity study consists of testing a dilution series of known concentrations. Then, the
difference between the measured concentration and the expected or known concentration is
determined and is evaluated against defined specifications. Visual evaluation can be performed
by plotting the measured concentration against the expected or known concentration.
Perform this procedure to verify that the linearity of the assay is within the manufacturer's
claims. The procedure is a simplified version of the study in Clinical and Laboratory Standards
Institute (CLSI) document EP06-A.
NOTE: For linearity data for assays on the Alinity ci‑series, see the assay documentation.
1. Prepare the commercial linearity material if necessary.

As an alternative step, prepare dilutions of the pooled samples:
a. Prepare a low sample pool with a concentration within 10% greater than the lower limit
of the measuring interval claim. Label the sample as level 1.
b. Prepare a high sample pool with a concentration within 10% less than the upper limit of
the measuring interval claim. Label the sample as level 5.
c. Prepare a level 2 sample with three parts of level 1 and one part of level 5.
d. Prepare a level 3 sample with two parts of level 1 and two parts of level 5.
e. Prepare a level 4 sample with one part of level 1 and three parts of level 5.
2. In replicates of three, test each level of the commercial linearity material or the pooled
samples.
3. To evaluate the data, perform the following steps:
a. Calculate the replicate mean concentration for each sample level.
b. Calculate the expected concentration for each sample level.
If admixtures were prepared, use the following equation:

80000071-105 - 2018-09-10
Verify the linearity Appendix A
Expected concentration = (C1 x V1 + C5 x V5) ÷ (V1 + V5)

Where:
C1 Concentration of level 1
V1 Volume part of level 1
C5 Concentration of level 5
V5 Volume part of level 5
c. Plot the replicate mean for each sample level on the Y-axis and plot the corresponding
expected concentrations on the X-axis.
d. Observe the graph for evidence of nonlinearity.
e. Calculate the percent difference (%D) between the expected concentration (EC) and
the replicate mean (RM) for each sample level:
%D = 100 x (RM - EC) ÷ EC
The assay linearity is verified if the percent difference for each sample level is within the
manufacturer's linearity claim limits in the assay documentation.
Linearity worksheet (c‑series), page 1502
Linearity worksheet (i‑series), page 1503
Linearity worksheet (c‑series)

Date: Analyte:

Reagent
Calibrators
Controls
Acid Wash
Alkaline Wash
Diluent
Data

80000071-105 - 2018-09-10
Appendix A Verify the linearity
Replicate Level 1 Level 2 Level 3 Level 4 Level 5

1
2
3
Data evaluation
Sample Expected Replicate mean %Difference Lower tolerance Upper tolerance

concentration limit limit
Level 1
Level 2
Level 3
Level 4
Level 5
Comments:
Technologist: Date:
Reviewed by: Date:
Linearity worksheet (i‑series)

Date: Analyte:

Reagent
Calibrators
Controls
Trigger Solution
Wash buffer
Reaction vessel
Diluent
Data

80000071-105 - 2018-09-10
Verify the linearity Appendix A
Replicate Level 1 Level 2 Level 3 Level 4 Level 5

1
2
3
Data evaluation
Sample Expected Replicate mean %Difference Lower tolerance Upper tolerance

concentration limit limit
Level 1
Level 2
Level 3
Level 4
Level 5
Comments:
Technologist: Date:
Reviewed by: Date:

80000071-105 - 2018-09-10
Appendix A Measuring interval
Measuring interval
Study results for linearity, precision, limit of quantitation (LoQ), and method comparison are used
to establish a measuring interval for an assay.
The Clinical and Laboratory Standards Institute (CLSI) Harmonized Terminology Database
defines the following terms:
Linear range "The range over which the testing systems results are
acceptably linear; that is, where nonlinear error is less than
the error criterion."
Measuring interval "Set of values of quantities of the same kind that can be
measured by a given measuring instrument or measuring
system with specified instrumental measurement uncertainty,
under defined conditions ([Joint Committee for Guides in
Metrology] 200:2012)."
Analytical "The range of analyte values that a method can directly

measurement range measure on the specimen without any dilution, concentration,
or other pretreatment, not part of the usual assay procedure."
Linear range, LoQ, and bias are performance characteristics. The measuring interval is derived
from these performance characteristics. To establish the measuring interval, a manufacturer
performs a linearity study so that samples encompass the entire measuring interval of the assay.
Samples that are assessed in precision and method comparison studies also encompass the
measuring interval of the assay.
Ultimately, the measuring interval is the range of concentration levels for which the assay has
been demonstrated to have acceptable linearity, precision, and bias. The extremes of the
measuring interval are limited by the LoQ on the lower end and by the upper linear limit on the
upper end.

80000071-105 - 2018-09-10
Verify an automated dilution Appendix A
Verify an automated dilution

Prerequisite Obtain a sample with a concentration value at the upper limit
of the measuring interval for an assay. Perform sample testing
within the same run.
Perform this procedure to verify that dilutions performed by the Alinity ci‑series are within
acceptance limits. A high-concentration sample at the upper limit of the measuring interval is
tested with the assay's undiluted sample protocol and with the automated dilution protocol.
Multiple replicate measurements are performed. The mean of the automated dilution protocol
results is compared to the expected diluted mean of the undiluted sample protocol results. The
difference between the means is determined and is evaluated against the acceptance criteria.
NOTE: Ten replicate measurements are performed with both the undiluted sample protocol and
the automated dilution protocol. This number of replicates is adequate for most assays with a
repeatability percent coefficient of variation (%CV) of less than 8% and a bias requirement of
greater than or equal to 10%.
1. Obtain a high-concentration sample at the upper limit of the measuring interval.
2. If necessary, dilute the sample to ensure that the concentration is within the measuring
interval of the assay.
This sample is the prepared sample.
3. Calibrate the assay.
4. Perform 10 replicate measurements of the prepared sample with the undiluted sample
protocol.
Ensure that the sample volume is adequate to test the sample for 10 replicates.
5. Perform 10 replicate measurements of the prepared sample with the automated dilution
protocol.
Ensure that the sample volume is adequate to test the sample for 10 replicates.
a. Calculate the mean of the prepared sample replicates tested with the undiluted sample
protocol. Use this value as the expected sample concentration (ES).
b. Calculate the mean of the prepared sample replicates tested with the automated
dilution protocol (DS).
c. Calculate the difference (D) between the ES and the mean of the diluted sample
replicates (DS):
D = DS - ES
d. Calculate the percent difference (%D):

80000071-105 - 2018-09-10
Appendix A Verify an automated dilution
%D = 100 x (DS - ES) ÷ ES
The automated dilution protocol is verified if the calculated %D is within the limits of the
acceptable percent bias.
Automated dilution verification worksheet (c‑series), page 1507
Automated dilution verification worksheet (i‑series), page 1508
Automated dilution verification worksheet (c‑series)

Date: Analyte:

Reagent
Calibrators
Controls
Acid Wash
Alkaline Wash
Diluent
Undiluted sample replicates
Replicate Concentration
1
2
3
4
5
6
7
8
9
10
Diluted sample replicates

80000071-105 - 2018-09-10
1
2
3
4
5
6
7
8
9
10
Data evaluation
Step Task Value

1 Mean of prepared sample, undiluted (ES)
2 Mean of prepared sample, autodiluted ________:________ (DS)
3 Difference = DS - ES
4 %Difference = 100 x (DS - ES) ÷ ES
5 Lower acceptance limit (-)________%
6 Upper acceptance limit (+)________%
Comments:
Technologist: Date:
Reviewed by: Date:
Automated dilution verification worksheet (i‑series)

Date: Analyte:

Reagent
Calibrators
Controls

80000071-105 - 2018-09-10
Appendix A Verify an automated dilution

Trigger Solution
Wash buffer
Reaction vessel
Diluent
Undiluted sample replicates
1
2
3
4
5
6
7
8
9
10
Diluted sample replicates
1
2
3
4
5
6
7
8
9
10
Data evaluation
Step Task Value

1 Mean of prepared sample, undiluted (ES)
2 Mean of prepared sample, autodiluted ________:________ (DS)
3 Difference = DS - ES

80000071-105 - 2018-09-10
Step Task Value

4 %Difference = 100 x (DS - ES) ÷ ES
5 Lower acceptance limit (-)________%
6 Upper acceptance limit (+)________%
Comments:
Technologist: Date:
Reviewed by: Date:

80000071-105 - 2018-09-10
Appendix A Method comparison
Method comparison
Method comparison is defined in one of the following ways:
Method comparison This evaluation determines the bias of an Alinity ci‑series

for quantitative assay (the candidate assay) to a comparator assay.
assays
Method comparison This evaluation determines the level of agreement between an
for qualitative assays Alinity ci‑series assay (the candidate assay) and a comparator
assay.
For specifications that are used for method comparison for the assays on the Alinity ci‑series,
see the assay documentation.
Perform a quantitative method comparison, page 1511
Perform a qualitative method comparison, page 1518
Perform a quantitative method comparison

• Reagent lot
• Calibrator lot
• Control material lot
• Forty specimens that encompass the measuring interval of both assays
NOTE: When possible, use biological specimens that are stored according to the specimen
storage claims. However, if specimens with concentrations in the upper limit of the measuring
interval are rare, testing samples can be prepared by supplementing low-concentration samples
with analyte from high-concentration samples.
Method comparison is a study conducted to determine the bias of a candidate assay to a
comparator assay. Two types of biases are determined: proportional bias and constant bias.
Proportional bias refers to the relative concentration change. Constant bias refers to the fixed
concentration change. Specimens from the intended population of the assay are sourced and
their concentrations are measured. Candidate assay measurements are compared to comparator
assay measurements across the assay measuring interval. Proportional bias, constant bias, and
strength of association are calculated. By definition, this study compares the candidate assay
quantification to the comparator assay quantification of the same analyte and the same quantity
of samples in the same matrix.

80000071-105 - 2018-09-10
Method comparison Appendix A
Perform this procedure to determine the quantitation bias of an Alinity ci‑series assay (the
candidate assay) to a comparator assay. This study is based on Clinical and Laboratory
NOTE: For method comparison data for assays on the Alinity ci‑series, see the assay
documentation.
1. Calibrate the assay on the Alinity ci‑series and on the comparator assay instrument system.
2. Perform quality control testing on both assays to verify the calibration.
3. Test the 40 specimens in single replicates according to the corresponding assay
documentation.
NOTE: If the assay method requires each specimen to be tested in duplicate and the test
results to be averaged, the average test result constitutes one replicate. Sample preparation
and testing can be performed on multiple days. Each day, prepare and test the same
sample with both methods.
4. For each specimen, record the following results:
– Candidate assay result
– Comparator assay result
– Difference between the candidate assay result and the comparator assay result
(Comparator assay result - Candidate assay result)
a. Plot the data so that the candidate assay result is on the Y-axis and the comparator
assay result is on the X-axis.
b. Visually determine if the data displays a linear relationship.
c. For any result that is noticeably outside the line, retest the specimen with both assays.
If the result is confirmed, evaluate the specimen for possible cross-reactivity by either
method and remove the specimen from the study.
d. Calculate the following metrics by using regression analysis:
• Correlation coefficient: The closeness of results by both methods for each
specimen
• Slope: The proportional bias or concentration increase by the investigational
method for every unit increase by the comparator method
• Intercept: The systemic bias or constant bias at any concentration within the
measuring interval
NOTE: The most common regression methodology is least squares regression, which
requires that the error in the candidate assay is distributed normally and that no error is
present in the comparator assay. These criteria are not typically met because both

80000071-105 - 2018-09-10
methods have errors. When the data shows increasing variability, weighted least
squares regression can be used to determine a more precise estimate of the bias (that
is, a smaller width of the 95% confidence interval). If no confidence interval is wanted,
both methodologies estimate the bias with the same trueness.
Passing-Bablok regression methodology does not use assumptions about the
distribution of errors. This nonparametric methodology is widely used in method
comparison studies. Deming regression methodology considers the variance of x and y,
and requires knowledge and input of the variability of both methods. A statistician may
be needed when the Passing-Bablok and Deming regression methodologies are used to
estimate biases. Generally, when the data is evenly distributed and has a relatively
constant variance, the least squares regression methodology yields biases that are
similar to the other methodologies.
e. Calculate the percent bias (%Bias) at each medical decision concentration (mdc):
Ymdc = Intercept + Slope • Xmdc
Biasmdc = Ymdc - Xmdc
%Biasmdc = Biasmdc ÷ Xmdc • 100
f. Plot the data in a scatterplot so that the average of the candidate assay result and
comparator assay result for each specimen is on the X-axis and the difference between
the candidate assay result and the average result is on the Y-axis.
Compare the method comparison results to the reference results provided in the candidate
If specific data is unavailable, the method comparison study is acceptable for most assays if the
following criteria are met:
• The correlation coefficient value is greater than 0.90.
• The slope value is between 0.90 and 1.10.
• The intercept value is near zero.
• The percent bias value at each medical decision concentration is less than 10%.
Method comparison: Quantitative worksheet (c‑series), page 1513
Method comparison: Quantitative worksheet (i‑series), page 1516
Method comparison: Quantitative worksheet (c‑series)

Date: Analyte:

Reagent

80000071-105 - 2018-09-10

Calibrators
Controls
Acid Wash
Alkaline Wash
Diluent
Data
Sample Comparator result (X-axis) Candidate result (Y-axis) Comparator result -

Candidate result
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26

80000071-105 - 2018-09-10

Candidate result
27
28
29
30
31
32
33
34
35
36
37
38
39
40
Summary statistics
Regression Number of samples Slope Intercept Correlation

methodology coefficient
Least squares
Weighted least
squares
Passing-Bablok
Deming
Bias at the medical decision concentration
Medical decision concentration Concentration by candidate Bias %Bias

(Xmdc) method (Ymdc)
1
2
Comments:
Technologist: Date:
Reviewed by: Date:

80000071-105 - 2018-09-10
Method comparison: Quantitative worksheet (i‑series)

Date: Analyte:

Reagent
Calibrators
Controls
Trigger Solution
Wash buffer
Reaction vessel
Diluent
Data

Candidate result
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19

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Candidate result
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
Summary statistics
Regression Number of samples Slope Intercept Correlation

methodology coefficient
Least squares
Weighted least
squares
Passing-Bablok
Deming
Bias at the medical decision concentration

1

80000071-105 - 2018-09-10

2
Comments:
Technologist: Date:
Reviewed by: Date:
Perform a qualitative method comparison

• Reagent lot
• Calibrator lot
• Control material lot
• Forty positive samples and 40 negative samples
NOTE: Specimens, reference panels, proficiency-testing samples, or other samples

characterized by the same matrix as specified in the assay documentation can be used.
Perform this procedure to determine the level of agreement between an Alinity ci‑series assay
(the candidate assay) and a comparator assay. The procedure does not determine or verify the
diagnostic accuracy of the assay method. This study is based on Clinical and Laboratory
NOTE: For method comparison data for assays on the Alinity ci‑series, see the assay
documentation.
1. Calibrate the assay on the Alinity ci‑series and on the comparator assay instrument system.
2. Perform quality control testing on both assays to verify the calibration.
3. Test the 40 positive samples and 40 negative samples in single replicates according to the
corresponding assay documentation.
NOTE: Sample preparation and testing can be performed on multiple days. Each day,
prepare and test the same sample with both methods.
4. For each sample, record the candidate assay result and the comparator assay result.
5. Count the number of positive results and negative results for each method, and then
summarize the results in a two-by-two table.

80000071-105 - 2018-09-10
6. Calculate the following percent agreements:

– Positive percent agreement (PPA) = 100 x [a ÷ (a + c)]
– Negative percent agreement (NPA) = 100 x [d ÷ (b + d)]
– Overall percent agreement (OPA) = 100 x [(a + d) ÷ (a + b + c + d)]
Comparator Comparator
Positive Negative
Candidate a b
Positive
Candidate c d
Negative
Where:
a Number of samples that tested positive with both

methods
b Number of samples that tested positive with the

candidate method but tested negative with the
comparator method
c Number of samples that tested negative with the

candidate method but tested positive with the
comparator method
d Number of samples that tested negative with both

methods
Compare the PPA, NPA, and OPA results to the reference values in the candidate assay
documentation. The PPA and NPA results need to be compared to the laboratory's own criteria.
The PPA and NPA results can be compared to the candidate documentation only if the
laboratory uses the same comparator method.
Method comparison: Qualitative worksheet (c‑series), page 1519
Method comparison: Qualitative worksheet (i‑series), page 1522
Method comparison: Qualitative worksheet (c‑series)

Date: Analyte:

80000071-105 - 2018-09-10

Reagent
Calibrators
Controls
Acid Wash
Alkaline Wash
Diluent
Data
Sample Candidate Comparator Sample Candidate Comparator

1 21
2 22
3 23
4 24
5 25
6 26
7 27
8 28
9 29
10 31
11 31
12 32
13 33
14 34
15 35
16 36
17 37
18 38
19 39
20 40

1 21
2 22
3 23
4 24

80000071-105 - 2018-09-10

5 25
6 26
7 27
8 28
9 29
10 31
11 31
12 32
13 33
14 34
15 35
16 36
17 37
18 38
19 39
20 40
Data evaluation
Count the number of positive results and negative results, and then summarize the results in a two-by-two table.
Positive Negative
Candidate a b
Positive
Candidate c d
Negative
a Number of samples that tested positive with both methods

b Number of samples that tested positive with the candidate method but tested negative with the
comparator method
c Number of samples that tested negative with the candidate method but tested positive with the
comparator method
d Number of samples that tested negative with both methods
Calculations
Calculate the following percent agreements:
Positive percent agreement (PPA) = 100 x [a ÷ (a + c)] =
Negative percent agreement (NPA) = 100 x [d ÷ (b + d)] =

80000071-105 - 2018-09-10
Total percent agreement (TPA) = 100 x [(a + d) ÷ (a + b + c + d)] =
Comments:
Technologist: Date:
Reviewed by: Date:
Method comparison: Qualitative worksheet (i‑series)

Date: Analyte:

Reagent
Calibrators
Controls
Trigger Solution
Wash buffer
Reaction vessel
Diluent
Data

1 21
2 22
3 23
4 24
5 25
6 26
7 27
8 28
9 29
10 31
11 31
12 32
13 33

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14 34
15 35
16 36
17 37
18 38
19 39
20 40

1 21
2 22
3 23
4 24
5 25
6 26
7 27
8 28
9 29
10 31
11 31
12 32
13 33
14 34
15 35
16 36
17 37
18 38
19 39
20 40
Data evaluation
Count the number of positive results and negative results, and then summarize the results in a two-by-two table.
Positive Negative
Candidate a b
Positive

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Candidate c d
Negative
a Number of samples that tested positive with both methods

b Number of samples that tested positive with the candidate method but tested negative with the
comparator method
c Number of samples that tested negative with the candidate method but tested positive with the
comparator method
d Number of samples that tested negative with both methods
Calculations
Calculate the following percent agreements:
Positive percent agreement (PPA) = 100 x [a ÷ (a + c)] =
Negative percent agreement (NPA) = 100 x [d ÷ (b + d)] =
Total percent agreement (TPA) = 100 x [(a + d) ÷ (a + b + c + d)] =
Comments:
Technologist: Date:
Reviewed by: Date:

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Appendix A Verify the reference range (expected values)
Verify the reference range (expected values)

• Reagent lot
• Twenty unique specimens from reference individuals from the laboratory subject population
• One replicate per specimen
Perform this procedure to verify the reference range, based on the definition from Clinical and
Laboratory Standards Institute (CLSI) document EP28-A3, when the reference range represents
95% of the expected values from a specific group of subjects. Do not use the procedure to
establish the reference range of a method.
The laboratory needs to establish its own reference range of a method if substantial differences
in the geographic location or demographic variables are present between the manufacturer's
reference range population and the laboratory's population. These factors can cause differences
in reference values.
1. Test one replicate per specimen.

2. Count the number of specimens that have concentration values that fall outside the
reference range.
NOTE: For reference range information for assays on the Alinity ci‑series, see the Expected
Values section of the assay documentation.
3. Evaluate the results:
– If two or fewer results (≤ 10%) fall outside the reference range and test, the range is
verified.
– If three or four results fall outside the reference range, obtain an additional 20
reference specimens that are similar to the first 20 reference specimens but are
collected from different subjects:
• If four or fewer of the 40 specimens fall outside the reference range, the range is
verified.
• If five or more results fall outside the reference range, the range is not verified and
the laboratory needs to establish its own reference range.
– If five or more results fall outside the reference range, the range is not verified and the
laboratory needs to establish its own reference range.

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Verify the reference range (expected values) Appendix A
Reference range (expected values) worksheet (c‑series), page 1526

Reference range (expected values) worksheet (i‑series), page 1527
Reference range (expected values) worksheet (c‑series)

Date: Analyte:

Reagent
Calibrators
Controls
Acid Wash
Alkaline Wash
Diluent
Data
Sample Concentration Sample Concentration

1 11
2 12
3 13
4 14
5 15
6 16
7 17
8 18
9 19
10 20

21 31
22 32
23 33
24 34
25 35
26 36
27 37

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Appendix A Verify the reference range (expected values)

28 38
29 39
30 40
Reference values
Reference range (expected values):
For reference range information for assays on the system, see the Expected Values section of the assay
documentation.
Results
Number of values that are outside the reference range:
Comments:
Technologist: Date:
Reviewed by: Date:
Reference range (expected values) worksheet (i‑series)

Date: Analyte:

Reagent
Calibrators
Controls
Trigger Solution
Wash buffer
Reaction vessel
Diluent
Data

1 11
2 12

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Verify the reference range (expected values) Appendix A

3 13
4 14
5 15
6 16
7 17
8 18
9 19
10 20

21 31
22 32
23 33
24 34
25 35
26 36
27 37
28 38
29 39
30 40
Reference values
Reference range (expected values):
For reference range information for assays on the system, see the Expected Values section of the assay
documentation.
Results
Number of values that are outside the reference range:
Comments:
Technologist: Date:
Reviewed by: Date:

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Appendix B List numbers
Introduction
List numbers are unique identifiers that are used to order products. The list numbers are
provided only for guidance and are subject to change. For the most current list numbers, contact
an Abbott Laboratories representative.
Consumable list numbers, page 1530
Consumable list numbers (c‑series), page 1531
Consumable list numbers (i‑series), page 1532
Service accessory list numbers, page 1533
Service accessory list numbers (c‑series), page 1534
Service accessory list numbers (i‑series), page 1537

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List numbers
Consumable list numbers Appendix B
Consumable list numbers

Consumables are replenishable items that are needed for sample processing on the
Alinity ci‑series. To order the following consumables, contact an Abbott Laboratories
representative.
For additional consumables that are specific to a processing module, see the appropriate
module type.
Table 45: Consumables
Item Quantity List number

Sample Cups 1000 per box 01R3801
Reagent Replacement Caps 100 per box 04R4701
Calibrator/Control Replacement Caps 100 per box 04R1001
List numbers, page 1529

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List numbers
Appendix B Consumable list numbers (c‑series)
Consumable list numbers (c‑series)

Table 46: Consumables (c‑series)

ICT Reference Solution 4 x 975 mL 08P7640
Acid Wash 2 x 500 mL 08P7740
Alkaline Wash 2 x 500 mL 08P7840
Detergent A 10 cartridges 08P9670
Detergent B 10 cartridges 08P9780
Acid Probe Wash 10 cartridges 01R6070
ICT Module 1 09D2804
c‑series Maintenance Solutions 10 cartridges 08P9870
c‑series Maintenance Solutions (USA) 10 cartridges 08P9871
c‑series Reagent Cartridge, Black (Large) 10 cartridges 04S1720
c‑series Reagent Cartridge, Black (Large) 10 cartridges 04S1750
c‑series Reagent Cartridge, Clear (Large) 10 cartridges 04S1740

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List numbers
Consumable list numbers (i‑series) Appendix B
Consumable list numbers (i‑series)

Table 47: Consumables (i‑series)

Concentrated Wash Buffer 2 x 2L 06P1368
Pre-Trigger Solution 4 x 975 mL 06P1265
Trigger Solution 4 x 975 mL 06P1160
Probe Conditioning Solution 2 x 48 tests 01R5840
Reaction Vessels 4000 per box 06P1401

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List numbers
Appendix B Service accessory list numbers
Service accessory list numbers

Service accessories are items that are used for system installation and for maintenance and
troubleshooting procedures. Some spare parts are used as needed for component replacement.
For service accessories that are specific to a processing module, see the appropriate module
type.
Table 48: Accessories

Tray 6 per box 04S6301
Sample Racks 10 per box 04R5202
Vial Rack 5 per box 04S6401
Onboard Vial Rack 5 per box 04S6501
External Waste Pump 1 04S7401
Hand Held Barcode Scanner 1 04S7701
Monitor 1 03R7201
Firewall 1 04S5601

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List numbers
Service accessory list numbers (c‑series) Appendix B
Service accessory list numbers (c‑series)

Three accessory kits are available for the Alinity c‑series:
• Accessory kit #1 contains items used for the installation of the system, items used to
perform maintenance and troubleshooting procedures, and some spare parts for as-needed
component replacement.
• Accessory kit #2 contains some items used during the installation of the system and items
used to perform maintenance and troubleshooting procedures.
• The customer maintenance kit contains all components needed to perform scheduled
maintenance for 1 year.
An Abbott Laboratories representative orders the accessory kits for customers. To order
individual items, contact an Abbott Laboratories representative.
Table 49: Alinity c accessory kit #1, LN 03R6802

Installation component:
• Filter, Water Bath 1 Not applicable (NA)
Maintenance components:
• Cuvette Segment Alignment Tool 1 04S7002
• Nozzle, Cleaning Wire 5 NA
• Phillips Screwdriver 1 NA
• Slotted Screwdriver 1 NA
• 10 mm/15 mm Wrench 1 NA
• 30 mL Syringe 2 NA
Spare components:
• Cuvette Dry Tip 1 04S5201
• Source Lamp 1 09D4503
• Sample and Wash Solution Syringe Seal Tip #1 1 09D3703
• Sample and Wash Solution Syringe Seal Tip #2 1 09D3803
• Reagent Syringe Seal Tip #1 2 09D3903
• Reagent Syringe Seal Tip #2 2 09D4004
• 1 mL Syringe 7 09D4103
• Sample Probe 1 04S5101
• Reagent Probe 1 04S4901
• Mixer 1 09D5903
• Sample and Wash Solution Syringe O-ring 2 09D5203
• Reagent Syringe O-ring 4 09D5303
• Sample Probe Tubing 1 01G4805

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List numbers
Appendix B Service accessory list numbers (c‑series)

• Reagent Probe Tubing 1 04S5001
• ICT Probe 1 09D6304
• ICT Probe Holder 1 NA
• Sample Probe Screw 1 04S5301
• Reagent Probe Screw 1 04S5401
Table 50: Alinity c accessory kit #2, LN 03R69

Maintenance components:
• Flashlight 1 NA
• Microfiber Cloth 1 NA
• Screwdriver, #2 Phillips 1 NA
• Hex Wrench, 3 mm 1 NA
• Cartridge Removal Tool 1 NA
• SH Barcode Tool 1 (2 per bag) 06E6902
• 25 mL Graduated Cylinder 1 N/A
Installation components:
• Pressure Monitor PCB 1 NA
• Water and Waste Tubing 7 NA
• Hex Screws 5 NA
• Hex Screws with Washers 4 NA
• Washers, Flat 4 NA
• Washers, Split Lock 4 NA
• Cable, CAT5E 1 NA
• Plastic cap 2 NA
• Tubing clamp 2 NA
Sample Tubes (16 mm x 100 mm) 2 NA
Sample Racks 30 NA
Vial Rack 10 NA
Onboard Vial Rack 5 NA
Tray 6 NA
Level Sensor, Bulk Solution 1 04S68
Table 51: Customer maintenance kit, LN 04S4601

ICT Check Valve 4 09D3503
Sample and Wash Solution Syringe Seal Tip #1 12 09D3703

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List numbers
Service accessory list numbers (c‑series) Appendix B

Sample and Wash Solution Syringe Seal Tip #2 12 09D3803
Reagent Syringe Seal Tip #1 8 09D3903
Reagent Syringe Seal Tip #2 8 09D4004
1 mL Syringe 28 09D4103
Source Lamp 4 09D4503
Sample and Wash Solution Syringe O-ring 12 09D5203
Reagent Syringe O-ring 8 09D5303
Table 52: Additional components

Cuvette Segment 1 04S4701
Sample Wash Solution Holder 1 04S7601
Wash Solution Check Valve 1 09D3403
High Concentration Waste Bottle 1 04T5801
High Concentration Waste Bottle Kit 1 04T5901

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List numbers
Appendix B Service accessory list numbers (i‑series)
Service accessory list numbers (i‑series)

Table 53: Alinity i accessory kit, LN 03R66

Customer Maintenance Kit: 1 04S3701
• Flashlight 1 Not applicable (NA)
• Microfiber Cloth 1 NA
• Optics Cap 1 NA
• Thermistor Removal Wrench 1 NA
• Valve Removal Tool 1 NA
• Fuse Kit 1 NA
• Ground Strap 1 NA
• Reverse Tweezers 1 NA
• Hex Wrench Set (mm): 2.5, 3, 4, and 6 1 NA
• O-ring Removal Tool 1 NA
• Cartridge Removal Tool 1 NA
• Lock Ring Release Tool 1 NA
• SH Barcode Tool 2 (2 per bag) 06E6902
Bag, Biohazard 12 NA
25 mL Graduated Cylinder 1 NA
Sample Rack 30 NA
Vial Rack 10 NA
Onboard Vial Rack 5 NA
Tray 6 NA
Pipettor Probes 2 (2 per box) 03R9601
Wash Zone Probe 7 (1 per box) 08C9436
Probe Tubing, Wash Zone 6 (3 per bag) 04S6002
Probe Tubing, Waste Aspirate 1 04S6101
Baffle, Wash Cup 3 (3 per bag) 04S6202
Level Sensor, Bulk Solution 1 04S68
Level Sensor, Diluted Wash Buffer 1 04S69
Installation items:
• Waste and Water Tubing 6 NA

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List numbers
Service accessory list numbers (i‑series) Appendix B
Table 54: Additional accessories

Diagnostics Kit 2 per box 01R59
Filter, Processing Center* 2 per container 04S6701
Maintenance Cleaning Cartridge 2 per box 02R52
* Four Filters, Processing Center, are shipped with the instrument.

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Appendix C Assay applications (c‑series photometric)
Introduction
The c‑series provides the capability to configure a user-defined assay for laboratory
implementation and verification. This appendix provides information about the photometric assay
parameters and is supplemental to the assay manufacturer's information.
NOTE: Information about the configuration of user-defined calculated assays is not presented in
this appendix, but can be found in the installation procedures and special requirements in this
manual.
Implementation of the user-defined photometric assay application includes the following items:
• Configuration of the user-defined assay parameters
NOTE: This procedure is also used to create a user-defined reagent, a user-defined diluent,
and a user-defined calibrator set. A maximum of 10 user-defined reagents may be created
for each system.
• Configuration of calibrator concentrations
• Configuration of quality control for the user-defined assay
• Preparation of the user-defined reagent and the user-defined diluent, including the
application of a 1D bar code label on the reagent cartridge
• An initial assay run
• Verification of the assay performance
• A reagent carryover evaluation
• Panel configuration (optional)
• Retest rule configuration (optional)
Edit general settings of assay parameters (calculated), page 291

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Assay applications (c‑series photometric)
Assay parameters (c‑series photometric, user defined) Appendix C
Assay parameters (c‑series photometric, user

defined)
The photometric user-defined assay parameters define the information needed to calibrate and
run samples for a user-defined assay. The parameters are displayed on the following five tabs of
the Assay Parameters screen:
• General
• Calibration
• Results
• Retest rules
• SmartWash
Assay Parameters screen element descriptions (c‑series photometric, user defined), page 1541
page 1543
New Reagent flyout element descriptions (c‑series photometric, user defined), page 1553
View/Edit Reagent flyout element descriptions (c‑series photometric, user defined), page 1554
defined), page 1556
New Cal Set flyout element descriptions (c‑series photometric, user defined), page 1563
page 1564
Color correction (c‑series photometric), page 1574
Dispense types (c‑series), page 1577
FlexRate method and absorbance range (c‑series photometric), page 1578
Maximum absorbance variation (c‑series photometric), page 1583
Maximum curve fit (c‑series photometric), page 1585
Photometric timing table (c‑series photometric), page 1586
Rate linearity percent (c‑series photometric), page 1587
Reaction check (c‑series photometric), page 1590
Sample dilution (c‑series photometric), page 1592
Self blank (c‑series photometric), page 1595

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Appendix C Assay parameters (c‑series photometric, user defined)
Calculate a calibration factor (c‑series photometric), page 1597

Retest Assays flyout element descriptions, page 286
Configure retest rules, page 299
Add an assay to a quality control, page 357
Assay Parameters screen element descriptions (c‑series photometric,

user defined)
The Assay Parameters screen displays the assays that are installed on the system.
Elements
Installed Assays Identifies the total number of assay parameter files that are
All tab Displays all assays that are available on the system.
i‑series tab Displays all assays that are available on one or more Alinity i
processing modules.
c‑series tab Displays all assays that are available on one or more Alinity c
processing modules.
Calculated tab Displays all calculated assays.
Function buttons

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Create Navigates to the Create Assay flyout where the operator can
• Calculated
• Photometric
View/Edit Navigates to the General tab of the Assay Parameters screen

for the selected assay or the first assay that is selected when
multiple assays are chosen.
Create Assay flyout element descriptions

In the Create Assay flyout, the system administrator can configure calculated assay parameters
or c‑series user-defined photometric assay parameters.
Elements
Calculated Displays an option that is used to create a calculated assay.
Photometric Displays an option that is used to create a c‑series user-

defined photometric assay.
NOTE: This option is not available on systems without an
Alinity c processing module.
Function buttons




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Assay Parameters screen, General tab element descriptions (c‑series

photometric, user defined)
The General tab of the Assay Parameters screen for a user-defined assay contains the
parameters that define the type of reaction to be performed, the wavelength and timing of the
absorbance readings, the reagent volumes, the sample dilutions, and the reaction validity
checks. The system administrator can edit all parameters. When no default is defined, the
parameter is empty by default.
In addition to the Assay Name and Assay Number parameters, the following parameters on the
General tab are highlighted in pink and must be defined before the parameters on the General
tab can be saved and navigation to other assay parameter tabs can be performed:
• Main (read times)
• Sample Blank Types
• Reagent
• Dilution Name
• Sample
Elements
Assay Name Displays a text box that is used to enter the assay name. The
assay name cannot match an existing assay name. The assay
name can have from 1 through 10 characters.
Assay Type Displays the assay protocol type. Only the Photometric and
Calculated assay protocol types are available for a user-
defined assay.
Assay Status Displays the assay status defined for the assay. Only the
Primary assay status is available for a user-defined assay.
Date/Time Displays the date and time that an operator configured the
Assay Number Displays a text box that is used to enter the number of the
assay file. For a user-defined assay, a value from 2000

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through 2999 can be configured. The assay number must be

the same number used for a host computer.
Result Units Displays the concentration units reported for the assay when
assay parameter configuration is completed.
Operator Displays the identification of the operator who configured the

parameters.
following settings:


Order screen.

screen.

(Default)

carousel. (Default)

carousel.

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Reaction Mode Displays a drop-down list that is used to select the type of
reaction that occurs for the assay. An end-point reaction is
completed when the absorbance values are stable. A rate
reaction is completed when the rate of change in absorbance
over time is constant. The following settings are available:
• End Up (default)
• End Down
• Rate Up
• Rate Down
Wavelength Displays drop-down lists that are used to select the primary
and secondary wavelengths. These wavelengths are used to
measure the assay concentration. One of the following
settings (in nanometers) can be configured for each
wavelength: 340, 380, 404, 416, 450, 476, 500, 524, 548, 572,
604, 628, 660, 700, 748, or 804. The default for the primary
wavelength is 340. An additional setting of None is available
only for the secondary wavelength.
NOTE: The primary wavelength may not be the same as the
secondary wavelength. If the exact wavelength setting is not
available, select the nearest wavelength setting.
The selection of bichromatic (primary and secondary)
wavelengths minimizes the interference from endogenous
inhibitors (for example, hemoglobin and bilirubin) that are
present in hemolyzed and icteric specimens.
Read Times Displays text boxes that are used to enter the starting and
ending photometric read points that define the following read
times:
Main Displays text boxes to configure the

read points used for data reduction.
Values from 1 through 38 can be
configured.
NOTE: For a rate reaction, the starting
read point must be less than the ending
read point. For an end-point reaction,
the starting read point must be less
than or equal to the ending read point.

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Flex If the Reaction Mode parameter is

Rate Up or Rate Down, text boxes are
displayed to configure the read points
used for data reduction when one read
or no reads performed during the main
read time fall within the configured
absorbance range. Values from 1
through 38 can be configured.
Results that are calculated by using the
absorbance data obtained from the flex
read time are identified with a FLEX
result flag. See FlexRate method and
absorbance range (c‑series
photometric), page 1578.
NOTE: If this parameter is defined, the
Absorbance Range parameter must
also be defined. The starting read point
must be less than the ending read
point. If one read point is undefined, the
other read point must be undefined.
Color Correction Displays text boxes to configure the

read points used to adjust the
absorbance range limits based on the
measured sample color. Values from 1
through 38 can be configured. See
Color correction (c‑series photometric),
page 1574.
NOTE: The starting read point must be
less than the ending read point. If one
read point is undefined, the other read
point must be undefined.
Absorbance Range If the Flex Read Time parameter is configured, text boxes are
displayed to configure the lower and upper absorbance limits
for the assay. Values from -0.1 through 3.2000 can be
configured.
All photometric readings need to fall within the absorbance
limits if the limits are defined. Any absorbance value that is
absorbance limits during the main read time or the flex read
time is not used to calculate the result.

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If the Absorbance Range values are undefined, the system

evaluates absorbance values against an internal range from
-0.1 through 3.0000. When absorbance values at the primary
wavelength exceed this range, the following message code is
generated for all reaction modes: 1038 Unable to calculate
result. Insufficient absorbance reads within absorbance range.
See FlexRate method and absorbance range (c‑series
photometric), page 1578.
Last Read Displays a drop-down list that is used to select the last
photometric read point required for result calculation. A value
from 1 through 38 (default) can be configured. Absorbance
data is not collected for photometric read points that occur
after the configured value and the data is not displayed in the
reaction graph. A value less than 38 reduces the assay
reaction time.
NOTE: The configured value must be greater than or equal to
the last read time for the Main, Flex, Blank, Color
Correction, or Reaction Check parameter.
If the default value is not edited, all 38 reads are completed
before results are reported regardless of the configured
values for the Main, Flex, Blank, Color Correction, and
Reaction Check parameters. The additional absorbance data
and reaction graph data from all 38 read points may be
helpful for troubleshooting during initial assay development.
Sample Blank Types Displays a drop-down list that is used to select the assay
blank type. The sample blank data is used to correct the
sample absorbance for the presence of color in the sample
as a result of lipemia, hemolysis, bilirubin, or other
interferences. The following settings are available:
• No Blank
• Self Blank
See Self blank (c‑series photometric), page 1595.
Blank Read Times If the Sample Blank Types parameter is Self Blank, text
boxes are displayed to configure the starting and ending
photometric read points that define the blank read time.
Values from 1 through 38 can be configured.
NOTE: For a rate reaction, the starting read point must be
less than the ending read point. For an end-point reaction, the
starting read point must be less than or equal to the ending
read point.

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Reagent area
Parameters for reagent and water dispense volumes are defined. These volumes and the
Sample area volumes for sample, diluent, and water dispense compose the cuvette volume. The
minimum cuvette volume is 80 µL. The maximum cuvette volume is 360 µL.
Reagent Displays a drop-down list that is used to select a configured

c‑series reagent to use for the assay. To configure a new
reagent, tap the New Reagent function button. See Create a
user-defined assay (c‑series photometric), page 1598.
Diluent Displays a drop-down list that is used to select a configured

c‑series sample diluent to use for the assay. The default is
None. To configure a new sample diluent, tap the New
Reagent function button. See Create a user-defined assay
(c‑series photometric), page 1598.
Diluent Dispense Displays a drop-down list that is used to select the reagent-
Mode pipetting profile the system uses to aspirate and dispense
diluents. The following settings are available:
• Type 2
• Type 6
See Dispense types (c‑series), page 1577.
Reagent Volume Displays text boxes that are used to enter the reagent 1 (R1)
and reagent 2 (R2) volumes (if required) that are dispensed
into the cuvette:
R1 A value from 20 µL through 250 µL can

be configured.
R2 A value from 20 µL through 160 µL can

be configured.
Water Volume Displays text boxes that are used to enter the water volume
dispensed with R1 and R2 concentrated reagents:
R1 A value from 20 µL to 230 µL can be

configured.
R2 A value from 20 µL to 140 µL can be

configured.

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Dispense Mode Displays drop-down lists that are used to select the reagent-
pipetting profile the system uses to aspirate and dispense
reagents. The following settings are available:
• Type 2
See Dispense types (c‑series), page 1577.

Validity checks for the reaction and the absorbance values measured during the reaction are
defined.
Reaction Check Displays a drop-down list that is used to select the reaction
type used to evaluate unexpected reaction performance. See
Reaction check (c‑series photometric), page 1590. The
None No reaction check is performed.

(Default)
End Subtraction The difference between the

absorbance measured during the A
Read Time range and the B Read Time
range (A - B) is calculated.
End Ratio The ratio of the absorbance measured

during the A Read Time range and the
B Read Time range (A ÷ B) is
calculated.
Rate Subtraction The difference between the rate per

minute measured during the A Read
Time range and the B Read Time range
(A - B) is calculated.
Rate Ratio The ratio of the rate per minute

measured during the A Read Time
range and the B Read Time range (A ÷
B) is calculated.

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A Read Time, B Read Displays text boxes that are used to enter the starting and
Time ending photometric read points for the A Read Time range
and B Read Time range used for the reaction check. Values
from 1 through 38 can be configured according to the
following criteria.
If one A Read Time value or one B Read Time value is
undefined, the corresponding A Read Time value or B Read
Time value must be undefined.
When the Reaction Check parameter is End Subtraction or
End Ratio, at least one read point must be defined and the
starting read point must be equal to or less than the ending
read point.
When the Reaction Check parameter is Rate Subtraction or
Rate Ratio, two read points must be defined and the starting
read point must less than the ending read point.
Calculation Limits Displays text boxes that are used to enter the lower and upper
limits for the acceptable range of the calculated read time
difference (A - B) or the calculated read time ratio (A ÷ B). If
the calculated value exceeds the limits, the assay result
becomes an exception and is not processed. Values from
-999999 through 9999999 can be configured for the lower
and upper limits. The lower limit value must be less than the
upper limit value.
Minimum Displays a text box that is used to enter the minimum

acceptable absorbance or absorbance change during the B
Read Time range. A value from -9.9999 through 9.9999 can
be configured.
Check parameter is End Ratio or Rate Ratio. The reaction
check is not performed if the absorbance change during the B
Read Time is less than the configured value for the Minimum
parameter.
Maximum Abs Displays a text box that is used to enter the acceptable
Variation absorbance variation allowed for absorbance readings during

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the main read time. When the absorbance variation exceeds

the defined limit, the assay result becomes an exception and
is not processed. A value from 0.0001 through 3.2 can be
Mode parameter is End Up or End Down. See Maximum
absorbance variation (c‑series photometric), page 1583.
Rate Linearity% Displays a text box that is used to enter the allowable
percentage change in absorbance that is measured during the
main read time or the flex read time. The validity check is
performed by using the first three readings and the last three
readings from the main read time or the flex read time. A
value from 1 through 99 can be configured or this parameter
can be undefined.
times. See Rate linearity percent (c‑series photometric), page
1587.
Sample area
Parameters for sample dispense are defined. The value for the Dilution Factor parameter is
calculated based on the configured assay parameter volumes and is not editable. See Sample
dilution (c‑series photometric), page 1592.
Dilution Name Displays a text box that is used to enter the assay dilution
name. A maximum of three dilution names can be configured.
The dilution name can have from 1 through 10 characters.
Sample Displays a text box that is used to enter the sample volume to
aspirate from the sample cup or tube for each configured
assay dilution. A value from 1.5 µL through 35 µL in
increments of 0.1 µL can be configured.
Diluted Sample Displays a text box that is used to enter the diluted sample
volume to aspirate from the cuvette for each configured assay
dilution. The diluted sample volume is aspirated from the
cuvette used to perform the onboard dilution and is dispensed
into a new cuvette. A value from 1.5 µL through 15 µL in
increments of 0.1 µL can be configured or this parameter can
be undefined.

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Diluent Displays a text box that is used to enter the sample diluent
volume to dispense into the cuvette for each configured assay
dilution. The R1 bottle of an empty reagent cartridge is filled
with a sample diluent, the bottle is bar-coded, and the
cartridge is loaded in the reagent carousel. A value from
20 µL through 345 µL in increments of 1 µL can be configured
or this parameter can be undefined.
Water Displays a text box that is used to enter the water volume to
dispense into the cuvette for each configured assay dilution. A
value from 25 µL through 300 µL in increments of 1 µL can be
Dilution Factor Displays the sample dilution factor that is calculated by the
Default Dilution Displays an option that is used to configure the dilution

protocol used as the default for sample orders. This
parameter is editable when more than one dilution name is
configured.
Function buttons


Save Saves changes.
New Reagent Displays the New Reagent flyout for user-defined assays.
View/Edit Reagent Displays the View/Edit Reagent flyout for assays that use
previously configured user-defined reagents.

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New Reagent flyout element descriptions (c‑series photometric, user

defined)
In the New Reagent flyout, the operator can configure user-defined reagent settings.
Elements
Reagent Name Displays a text box that is used to enter the name of the user-
defined reagent. The reagent name has six alphanumeric
characters.
Reagent Type Displays a drop-down list that is used to select the reagent
type:
• R1 (default)
• R1 and R2
• Sample Diluent
Low Alert Displays a text box that is used to enter the reagent low alert.
A notification is displayed when the number of tests in all
onboard cartridges falls below the defined value. A value from
0 through 999999 can be configured.
NOTE: The sample diluent low alert value corresponds to the
percentage of the remaining volume for a sample diluent. The
range is from 0% through 50%.
Number of Tests Displays a text box that is used to enter the number of tests
for each cartridge of the user-defined reagent. A value from 0
When the number of tests is determined, the following values
need to be considered:
• The dead volume of the R1 and R2 bottles
• The overaspiration volumes for the reagent dispense
types used by the assay
NOTE: This parameter is unavailable for a sample diluent.
Onboard Stability Displays a text box that is used to enter the onboard stability
in hours. A value from 0 through 9999 can be configured.

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Run Calibrations for Displays the following options:

Reagent by
Lot Runs the calibrations on one cartridge
of each lot loaded on the reagent
carousel.
Cartridge Runs the calibrations for each reagent

lot and cartridge combination loaded on
Function buttons



View/Edit Reagent flyout element descriptions (c‑series photometric,

user defined)
In the View/Edit Reagent flyout, the operator can edit user-defined reagent settings.
Elements
Reagent Name Displays the name of the user-defined reagent.

NOTE: This parameter cannot be edited.
Reagent Type Displays the reagent type.

NOTE: This parameter cannot be edited.

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Low Alert Displays the reagent low alert as the number of tests for a
reagent and the percentage of the remaining volume for a
sample diluent.
NOTE: The low alert value cannot be edited in the flyout. The
value can be edited on the Reagents/Diluents tab of the
Reagents and Supplies screen.
Number of Tests Displays a text box that is used to edit the number of tests for
each cartridge of the user-defined reagent. A value from 0
NOTE: If the number of tests is edited after reagent cartridges
are created, only the reagent cartridges created after the edit
reflect the new value.
Onboard Stability Displays a text box that is used to edit the onboard stability in
hours. A value from 0 through 9999 can be configured.
NOTE: If the onboard stability is edited after reagent
cartridges are created, only the reagent cartridges created
after the edit reflect the new value.
Run Calibrations for Displays the configured option:

Reagent by
Lot Runs the calibrations on one cartridge
of each lot loaded on the reagent
carousel.
Cartridge Runs the calibrations for each reagent

lot and cartridge combination loaded on
NOTE: This parameter cannot be edited in the flyout.
Function buttons




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Assay Parameters screen, Calibration tab element descriptions

(c‑series photometric, user defined)
The Calibration tab of the Assay Parameters screen for a user-defined assay contains the
parameters that define the calibration method, the calibrator set, the calibrator interval, the
calibrator sample volumes, and the calibration validity checks. The system administrator can edit
all parameters. When no default is defined, the parameter is empty by default.
The Replicates and Sample parameters on the Calibration tab are highlighted in pink and must
be defined before the parameters on the Calibration tab can be saved and navigation to other
assay parameter tabs can be performed.
Elements

parameters.
Calibration area
The calibration method and expiration interval for the full calibration are defined. If required, the
calibration adjustment type and interval are defined.
Calibration Method Displays a drop-down list that is used to select the calibration
method:

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• Absorbance
• Factor
• Linear (default)
• Logit-4
• Spline
The selected calibration method determines the additional

parameters that are displayed on the tab. For more
information about the calibration types and methods, see the
calibration section in this manual.
Full Calibration Displays a text box that is used to enter the amount of time in
Interval hours that the full calibration curve is valid after a full
configured.
NOTE: If 0 is configured, the full calibration interval is not
tracked.
Factor Displays a text box that is used to enter the calibration factor
when the Calibration Method parameter is Factor. A value
from 0 through 9999999 can be configured.
Default Ordering Type Displays a drop-down list that is used to select the default
calibration type used to create calibration orders for the
assay:
• Full
• Adjust

parameter is None.
Use Cal Factor From Displays a drop-down list that is used to select the assay to
reference for calibration information used in result calculation.
Configured c‑series photometric assays are used to configure
this parameter.
Method parameter is Use Cal Factor Blank. The assay
selected as the reference assay may not use the Use Cal
Factor Blank calibration method.
This parameter may be used when two assays use the same
reagent and have the same sample volume to reagent volume

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ratios. For example, a urine application may reference the

serum application for calibration data.
Adjust Type Displays a drop-down list that is used to select the type of
adjust calibration performed for the assay:
• None (default)
• Blank
• 1-Point
• 2-Point
For more information about the adjust types, see the

calibration section in this manual.
Method parameter is Linear, Spline, or Logit-4. If the Adjust
Type parameter is 1-Point or 2-Point, the Adjust Level
parameter must be defined.
This parameter may be used as an alternative to a reduction
of the full calibration interval when day-to-day absorbance
variations cause quality control values to exceed the
acceptable total precision for an assay. One example is to
perform an adjust calibration when new reagent cartridges are
loaded on the system.
Adjust Interval Displays a text box that is used to enter the amount of time in
hours that the adjust calibration is valid after an adjustment
configured.
parameter is None.
If 0 is configured, the adjust calibration interval is not tracked.
Adjust Level Displays a drop-down list that is used to select a configured

calibrator level for the calibrator set (Cal 1 to Cal 6) to use
for the 1-Point and 2-Point adjust calibration types.

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Calibrators area
The calibrator set, replicates, and parameters for calibrator dispense volumes are defined. To
minimize the number of calibrators that need to be loaded on the system, one calibrator level
can be diluted to create additional calibrator levels.
NOTE: All calibrator and sample dilutions are compared to the volumes defined for the highest
calibrator level to determine the dilution factor. If the sample volume of the highest calibrator
does not equal the standard sample volume, concentration values on the Calibration Status
Details screen will not reflect the dilution factor. However, because an assay-specific dilution
factor is generated internally, sample results are calculated accurately.
Calibrator Set Displays a drop-down list that is used to select the calibrator
set name. The available settings are None (default) and the
configured c‑series calibrator set names. If the Calibration
Method parameter is Factor, None needs to be selected. New
user-defined calibrator sets can be configured in the New Cal
Set flyout.
NOTE: This parameter is unavailable when the Calibration

replicates to run for the blank and each configured calibrator
level for assay calibration. A value from 1 through 3 can be
configured.
To calculate the calibration for a user-defined assay, only one
valid calibrator replicate is required for each calibrator level.
The absorbance value used to calculate the calibration is
based on the number of valid replicates:
• For one valid replicate, one absorbance value is used.
• For two valid replicates, the average of the absorbance
values is used.
• For three valid replicates, the maximum and minimum
absorbance values are excluded and the remaining
median absorbance value is used.
Calibrator Level Displays the name of the blank and displays a maximum of six
calibrator levels used as points in the calibration:
Blank This parameter can be configured as

Water (default) or as one of the
calibrator levels for the configured
calibrator set.

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The Blank level is considered as a

reagent blank for the assay because
the absorbance measurement is
performed only with water (or the blank
calibrator) and the reagent in the
cuvette. For enzymatic assays or rate
assays, the blank may also be
considered as a kinetic blank.
NOTE: When the Calibrator Set
parameter is None, Water is the only
available setting for the Blank
parameter. Water for the blank is
dispensed by the sample probe. Thus,
a manually loaded water sample is not
required.
Cal 1 through Cal 6 Each parameter can be configured as

Water or as one of the calibrator levels
for the configured calibrator set.
NOTE: This parameter is unavailable when the Calibration

Sample Displays the sample volume dispensed into the cuvette for the
blank and for each configured calibrator level. A value from
1.5 µL through 35 µL can be configured or this parameter can
be undefined.
Diluted Sample Displays the diluted sample volume for the blank and for each
configured calibrator level. The diluted sample volume is
dilution protocol is defined for the calibrator. A value from
1.5 µL through 35 µL can be configured or this parameter can
be undefined.
Diluent Displays the diluent volume for the blank and for each
protocol is defined for the calibrator. A value from 20 µL
through 345 µL can be configured or this parameter can be
undefined.
NOTE: The sum of the diluent volume and the water volume
must be greater than or equal to 45 µL.

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Water Displays the water volume used to dilute a concentrated

diluent for the blank and for each configured calibrator level.
The water volume is dispensed with any aspirated diluent into
the cuvette for dilution during calibration if a dilution protocol
is defined for the calibrator. A value from 25 µL through
345 µL can be configured or this parameter can be undefined.
NOTE: The sum of the diluent volume and the water volume
must be greater than or equal to 45 µL.

Validity checks for the calibration and the measured calibrator absorbance values are defined.
Blank Absorbance Displays text boxes that are used to enter the lower and upper
Range limits that define an acceptable blank absorbance value
measured during calibration:
Lower limit A value from -9.9999 through 9.9998

can be undefined.
Upper limit A value from -9.9998 through 9.9999

can be undefined.

performed. If this parameter is defined and any blank
replicate exceeds the configured range, the calibration fails.
Span Displays a drop-down list that is used to select the calibrator

level used as the upper limit of the calibration span that is
evaluated for the Span Absorbance Range check. This
parameter can be configured as one of the calibrator levels
defined for the assay or can be undefined.
span.
Span Absorbance Displays text boxes that are used to enter the lower and upper
Range limits that define an acceptable absolute absorbance
difference between the blank calibrator and the configured
calibrator level for the Span parameter:

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Lower limit A value from 0.0001 through 9.9998

can be undefined.
Upper limit A value from 0.0002 through 9.9999

can be undefined.

If the span absorbance difference exceeds the configured
limits for the Span Absorbance Range parameter, the
calibration fails.
Expected Cal Factor Displays a text box that is used to enter the target value for
the calibration factor (1/slope) when the calibration is
calculated. A value from -999999.99 through 9999999.99 can
be configured.
evaluated.
See Calculate a calibration factor (c‑series photometric), page
1597.
Expected Cal Factor Displays a text box that is used to enter the percent tolerance
Tolerance % of the calibration factor that is expected when the calibration
is calculated. This parameter is used with the Expected Cal
Factor parameter to determine an acceptable range for the
calibration factor. A value from 1 through 99 can be
evaluated.

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See Calculate a calibration factor (c‑series photometric), page

1597.
Maximum Curve Fit Displays a text box that is used to enter the parameter for
maximum curve fit. This parameter specifies the maximum
limit of the sum of the absolute values of the difference
between the approximated absorbance of the calculated
calibration and the measured absorbance. A value from
0.0001 through 9.9999 can be configured or this parameter
can be undefined.
See Maximum curve fit (c‑series photometric), page 1585.
Function buttons


Save Saves changes.
New Cal Set Displays the New Cal Set flyout for user-defined assays.
New Cal Set flyout element descriptions (c‑series photometric, user

defined)
In the New Cal Set flyout, the system administrator can configure user-defined calibrator
settings.

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Elements
Calibrator Set Name Displays a text box that is used to enter a calibrator set name.
The calibrator set name can have from 1 through 10
characters.
Calibrator Set Levels Displays a drop-down list that is used to select the number of
levels. A value from 1 (default) through 6 can be configured.
Function buttons



Assay Parameters screen, Results tab element descriptions (c‑series

photometric, user defined)
On the Results tab of the Assay Parameters screen, the system administrator can edit result
and interpretation settings.
Elements

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parameters.
Result Units area
Result Units Displays a text box that is used enter a unit name. The unit
name can have from 0 through 8 characters.
Decimal Places Displays a drop-down list that is used to select the number of
decimal places to display for an assay result. Zero through
four decimal places can be configured.
Result Unit UCUM Displays a text box that is used to enter the Unified Code for
Units of Measure (UCUM) for the result unit. The UCUM result
unit can have from 0 through 20 characters. The UCUM is a
system of codes that represents the measurement units that
are contemporarily used in international science, engineering,
and business. The UCUM can be used by host computers.
Correlation Factor Displays a text box that is used to enter a factor for c‑series
assays if results require a calculation to match another
system. A value from 0 through 99999.9999 can be
configured. The default is 1.0000.
A method comparison study needs to be performed to
determine the correlation factor and intercept. For more
information, see the appendix for verification of assay claims.



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automated dilution
factor applied
Intercept Displays a text box that is used to enter an intercept for

c‑series assays if results require a calculation to match
another system. A value from -9999.9999 through 99999.9999
can be configured. The default is 0.0000.
A method comparison study needs to be performed to
determine the correlation factor and intercept. For more
information, see the appendix for verification of assay claims.


automated dilution
factor applied
Results area
The linearity range and the normal and extreme ranges for gender and age can be configured
and the current settings are displayed.
Low Linearity Displays a text box that is used to enter the low limit value of
the measuring interval.
NOTE: The system adjusts the configured linearity value by
the sample dilution factor. If the assay has a standard sample
dilution factor other than 1.00, the linearity value needs to be
edited to account for the sample dilution factor.
High Linearity Displays a text box that is used to enter the high limit value of
the measuring interval.
NOTE: The system adjusts the configured linearity value by
the sample dilution factor. If the assay has a standard sample
dilution factor other than 1.00, the linearity value needs to be
edited to account for the sample dilution factor.
Gender Displays the gender for configured result flags. Result flags
are evaluated based on the sample data that was configured

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in the Patient Details flyout. The following settings are

available:
• Male
• Female
• Either
NOTE: This range may be used with any gender setting
(male, female, and unknown).
Age Unit Displays the age unit for the configured age range. The
• Days
• Months
• Years
Age Range Displays the age range for configured result flags. The
• 0 - 365 (Days)
• 0 - 24 (Months)
• 0 - 130 (Years)
Normal Range Displays the normal range for the configured gender and age
range.
Extreme Range Displays the extreme range for the configured gender and age
range.
NOTE: Assay results are evaluated against the configured ranges in the order in which they are
displayed. To ensure that the ranges for gender and age are evaluated first, those ranges must
be configured first.
Interpretation area
Result interpretation settings can be configured and the current settings are displayed.
Name Displays a drop-down list that is used to select the

interpretation name:
• Nonreactive
• Reactive
• Grayzone

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• GZ-Reactive
• GZ-Nonreactive
• High Reactive
• Normal
• Abnormal
• Positive
• Negative
• Intermediate
• 1+
• 2+
• 3+
• 4+
• <UserDefined> (Customized text can be configured.)
• <NotDefined> (No interpretation is provided.)
• <Blank> (A range can be configured without
interpretation text.)
NOTE: Interpretation settings must be configured beginning

with the first row. Rows cannot be skipped and the Name text
box cannot be empty. To configure a range without
interpretation text, <Blank> must be selected.
Range Displays a text box that is used to enter the range for the
interpretation.
Review Required Displays a check box that is used to select which results are
held until they are reviewed and released manually.
Function buttons


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Add Result Displays the Add Result flyout, which is used to configure a
new result range.

Save Saves changes.
Edit Result Displays the Edit Result flyout, which is used to edit
configured result ranges.
Delete Result Displays a message requesting confirmation to delete the

selected result range.
Assay Parameters screen, SmartWash tab element descriptions

(c‑series)
The SmartWash tab of the Assay Parameters screen displays configured SmartWash protocols.
On this tab, the operator can configure additional SmartWashes for reagent probes, sample
probes, and cuvettes and can edit user-defined SmartWashes. The washes reduce assay-to-
assay interference (carryover). Carryover can occur between successive sample probe
aspirations or when the reagent for an interfering assay is dispensed before the reagent for an
affected assay. When possible, the system attempts to avoid performing the washes by
modifying the assay sampling sequence of the tests that are ordered for each sample.
NOTE: Settings in the SmartWash Information area and the Define SmartWash area are
editable for user-defined assays. In the SmartWash Information area, the configured
SmartWash protocols and the virtual line designation cannot be changed for non-user-defined
assays. Additional SmartWashes are displayed in the order in which they are configured.
Elements

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parameters.
SmartWash Information area
Virtual Line Displays a drop-down list that is used to select the cuvette
setting for assay processing. Assays that interfere with each
other can be assigned to separate virtual lines to avoid
interference. The following settings are available:
• Line A: Only the Line A cuvettes (odd-numbered cuvettes)
are used for assay processing.
• Line B: Only the Line B cuvettes (even-numbered
cuvettes) are used for assay processing.
• Both: Both the Line A and Line B cuvettes are used for
assay processing. (Default)
Component Displays the hardware component used for the configured

SmartWash. The following components may be displayed:
• Reagent Probe R1
• Cuvette
• Sample Probe
Reagent/Assay Displays the reagent name of the interfering reagent.

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NOTE: This parameter is not displayed when the Component

parameter is Sample Probe.
Wash Solution Displays the wash solution used for the configured
SmartWash. The following wash solutions may be displayed:
• Detergent A
• Detergent B
• Acid Probe Wash
• Water
Volume Displays the volume of wash solution used for the configured
SmartWash.
NOTE: This parameter is not displayed when the Component
Replicates Displays the number of replicates for the configured

SmartWash for the Reagent Probe R1 component or the
Reagent Probe R2 component.
Define SmartWash area
Component Displays the following hardware component options for a

SmartWash configuration:
Reagent Probe R1 When an interfering assay precedes an

affected assay, the R1 probe aspirates
the required volume of wash solution to
clean the probe between the reagents
and dispenses the wash solution into
an empty cuvette to clean mixer 1. An
extra cuvette is used for this
SmartWash.
Reagent Probe R2 When an interfering assay precedes an

affected assay, the R2 probe aspirates
the required volume of wash solution to
clean the probe between the reagents
and dispenses the wash solution into
an empty cuvette to clean mixer 2. An
extra cuvette is used for this
SmartWash.

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Cuvette If an interfering assay was measured in

a cuvette during any one of the last
three uses of the cuvette, wash solution
is added to the cuvette to perform the
SmartWash. The system evaluates
cuvettes until an acceptable cuvette is
identified, and then the sample is
dispensed.
Sample Probe All user-defined SmartWashes for a

sample probe wash the sample probe
with wash solution before sample
aspiration. For each wash that is
performed, throughput is delayed by
one cycle.
Interfering Reagent Displays a list that is used to select one or all interfering
reagents. One of the following hardware component options
can be selected for the interfering reagents:
Reagent Probe R1 Displays a list of all configured c‑series

reagents and sample diluents, and an
All setting.
Reagent Probe R2 Displays a list of all configured c‑series

reagents and an All setting.
Cuvette Displays a list of all configured c‑series

reagents.
Sample Probe This parameter is not applicable for the

Sample Probe component option.
NOTE: When the All setting is selected, the reagent probe is

washed regardless of which assay was previously run. This
setting is not used to perform a wash between consecutive
dispenses of the same reagent. To perform a wash between
aspirations of the same reagent, a separate SmartWash for
the reagent probe needs to be configured for the specific
reagent. The SmartWash that uses the All setting needs to be
configured last.
Wash Solution Displays a drop-down list that is used to select one of the
following wash solutions for the SmartWash:
• Detergent A (default)

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• Detergent B
NOTE: Detergent B is unavailable for the Sample Probe
component option.
• Acid Probe Wash
• Water
NOTE: Water is unavailable for the Cuvette component
option.
Wash Volume Displays a text box that is used to enter the volume of wash
solution used for the SmartWash. One of the following
hardware component options can be selected for the wash
volume:
Reagent 1 Probe Values from 45 µL through 345 µL

(default) can be configured.
Reagent 2 Probe Values from 20 µL through 345 µL

(default) can be configured.
Cuvette A value of 345 µL is displayed.
NOTE: This parameter is unavailable for the Sample Probe

component option.
Replicates Displays a drop-down list that is used to select the number of

times to perform the SmartWash. Values from 1 (default)
NOTE: This parameter is available only for the Reagent
Probe R1 and Reagent Probe R2 component options.
Function buttons


Save Saves changes.
Add SmartWash Adds the SmartWash to the SmartWash Information area.

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Delete SmartWash Deletes the selected user-defined SmartWash from the

SmartWash Information area.
Color correction (c‑series photometric)

If the Absorbance Range parameter is configured, the color correction parameter adjusts the
upper and lower limits of the absorbance range to correct for the presence of color in the
sample. Any flags or message codes generated use the adjusted absorbance range and reflect
the analyte concentration instead of the sample color. The adjusted range also determines if flex
read time data is used for result calculation.
To perform the adjustment, the system measures the sample absorbance at the primary
wavelength for each photometric read point during the configured color correction read time.
The reagent blank is subtracted from the sample absorbance value, which is determined by data
reduction calculation, to determine the absorbance as a result of sample color. The following
formula is used:
AColor = AS - ARB
Where:
AColor Absorbance as a result of sample color
AS Absorbance of the sample during the color correction read

time
ARB Absorbance of the reagent blank. The reagent blank value is

obtained during assay calibration.
If the color correction read time starts before the addition of the second reagent, the system
corrects the absorbance measured during the color correction read time for the sample volume
and reagent volume. The following formula includes the volume correction:
AColor = (AS - ARB) x (A ÷ B)
Where:
A Sample volume + Reagent 1 volume + Reagent 1 water

volume

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B Sample volume + Reagent 1 volume + Reagent 1 water

volume + Reagent 2 volume + Reagent 2 water volume
NOTE: If the diluted sample volume is not zero, the diluted sample volume is used in the volume
correction instead of the sample volume.
The color correction check is not performed in the following instances:
• When the Color Correction read time parameter is undefined
• When the Absorbance Range parameter is undefined
• When the sample is part of a calibration
• When the color correction absorbance change is negative
The following graphs are examples of a normal sample and a lipemic sample with adjustment for
color correction.
Figure 170: Normal sample (c‑series photometric)
Where:
Abs Absorbance
S Sample dispense
R1 First reagent dispense
R2 Second reagent dispense

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C Color correction read time
M Main read time
AbU Absorbance range upper limit
AbU' Adjusted absorbance range upper limit
Rblk Reagent blank
N Normal sample
Figure 171: Lipemic sample (c‑series photometric)
Where:
Abs Absorbance
S Sample dispense

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C Color correction read time
M Main read time
AbU' Adjusted absorbance range upper limit
Rblk Reagent blank
L Lipemic sample
Dispense types (c‑series)

The following reagent-pipetting profiles are available to aspirate and dispense reagents. The
syringe speed differences that are listed in the following table are relative to those of Type 1
dispense, which is the default dispense type.
NOTE: Dispense type 5 is available only for R2 reagents. Type 6 is available only for R1
reagents. Sample diluents use the R1-pipetting profile options.
Table 55: Dispense types (c‑series)
Type Volume Syringe speed Overaspiration Volume

(µL) volume correction
1 (Default) • 20 to 100 Normal Normal Yes
• 101 to 270 (8% + 6 µL)
• 271 to 345
2 • 20 to 100 Normal Decreased Yes
• 101 to 270 (4% + 3 µL)
• 271 to 345
5 (R2 only) • 20 to 100 • Normal Normal Yes
• 101 to 180 • Faster (126% of normal) (8% + 6 µL)
• 181 to 345 • Normal
6 (R1 only) • 20 to 100 • Normal Normal Yes
• 101 to 180 • Slower (59% of normal) (8% + 6 µL)
• 181 to 345 • Normal
The following information may be used to determine which dispense type to use.

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Type Intended use Notes

1 General purpose Not recommended for viscous or foaming reagents
2 Minimal reagent waste Not recommended for viscous or foaming reagents
5 Viscous or foaming reagents Not available for R1 reagents or diluents
6 Viscous or foaming reagents Not available for R2 reagents
FlexRate method and absorbance range (c‑series photometric)
FlexRate method
The FlexRate method is used to determine the concentration of high-activity and high-
concentration samples for a rate assay that exceeds the linear range.
The flex read time occurs before the main read time and can be used when sufficient substrate
is present and the reaction rate is linear. The Flex Read Time parameter is available only for
assays that have the Reaction Mode parameter configured as Rate Up or Rate Down. The flex
read time is used when one of the first two reads in the main read time exceeds the absorbance
range. Results that are calculated by using the absorbance data obtained from the flex read time
are identified with a FLEX result flag.
Figure 172: Example of the FlexRate method (c‑series photometric)

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Where:
Abs Absorbance
S Sample dispense
F Flex read time
M Main read time
AbL Absorbance range lower limit
N Normal sample
H High-concentration sample
NOTE: If the Flex Read Time parameter is configured, the Absorbance Range parameter must
also be configured.
Absorbance range
The Absorbance Range parameter defines the lower and upper absorbance limits for the
photometric read points for an assay. If the parameter is configured, the system evaluates the
absorbance values at the primary wavelength against the defined range.
If the parameter is not configured, the system evaluates the absorbance values for each
photometric read point at the primary wavelength against an internal range from -0.1 through 3.0
absorbance units.
When absorbance values exceed either the upper limit or the lower limit, the data is not used for
result calculation. The following message code is generated for all photometric reaction mode
types: 1039 Unable to calculate result. Absorbance exceeded optical limits.
The absorbance range is evaluated during the following read times if the read times are
configured:
• Blank read time
• Color correction read time
• Flex read time
• Main read time
• Reaction check read time

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The absorbance range helps to detect unexpected assay performance and determines when
absorbance data from the flex read time is used for result calculation.
If the absorbance value for the photometric read points in the main read time exceed the
absorbance limits, the data is not used for result calculation. If the number of acceptable
absorbance data points in the main read time is insufficient and the flex read time is defined, the
flex read time data is used for result calculation if the data falls within the absorbance range. If
the flex read time is undefined or the number of acceptable absorbance data points in the flex
read time is insufficient, the result becomes an exception.
NOTE: If some data within the main read time or the flex read time falls outside the absorbance
range, but the absorbance range has sufficient data to calculate a result, the system generates
the result. The A#1 flag or the A#2 flag is applied to the result to indicate that the data from only
one or two photometric read points was used.
Because a rate assay result requires data from a minimum of two photometric read points, the
A#1 flag is not applied to results that are calculated by using the flex read time. If the data from
only one point or no read point falls within the absorbance limits for a rate reaction, the result
becomes an exception.
Figure 173: Example of the absorbance range (c‑series photometric)
Where:
Abs Absorbance

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S Sample dispense
F Flex read time
M Main read time
AbL Absorbance range lower limit
U Unexpected reaction performance
N Normal sample
H High-concentration sample
Linearity flagging (c‑series)

The application of linearity flags is influenced by the data reduction method of the assay. Assays
with linear calibration methods are evaluated by using the configured linearity flags. Assays with
nonlinear calibration methods, spline and logit-4, use an additional extrapolation flag. The
extrapolation flag is an internal limit that cannot be viewed. The flag is applied to samples that
have absorbance values that exceed the highest calibrator absorbance.
Linearity flagging for the linear data reduction method
The following steps describe the linearity evaluation performed for assays that use the linear
data reduction method:
1. The sample absorbance value is used to calculate a concentration value.
2. The concentration is corrected by the configured correlation factor and intercept.
3. The concentration is corrected by the sample dilution factor. This value is the adjusted
sample concentration.
4. The configured linearity value is adjusted by the sample dilution factor. This value is the
adjusted linearity value.
5. A linearity check is performed to determine whether the adjusted sample concentration is
greater than the adjusted linearity value:

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a. If the adjusted sample concentration is less than the adjusted linearity value, the
linearity flag is not generated and the adjusted sample concentration is reported.
b. If the adjusted sample concentration is greater than the adjusted linearity value, the
linearity flag is generated and reflects the adjusted linearity value.
Table 56: Linear calibration method
Sample dilution factor 2

Linearity limit 500
Calculated concentration 485
Correlation factor 1.10
Correlation intercept 0
Adjusted concentration = [(Calculated concentration x Correlation factor) + Intercept] x Sample dilution

factor
1067 = [(485 x 1.10) + 0] x 2
Adjusted linearity value = Entered linearity value x Sample dilution factor
1000 = 500 x 2
The adjusted concentration exceeds the adjusted linearity value. Thus, the sample result is
reported as greater than the adjusted linearity (> 1000).
Linearity flagging for spline and logit-4 nonlinear data reduction methods
The following steps describe the linearity evaluation performed for assays that use the spline or
the logit-4 data reduction method:
1. The sample absorbance is evaluated against the highest calibrator absorbance, the
extrapolation limit:
a. If the sample absorbance is less than the extrapolation limit, the sample is evaluated
according to linearity flagging for assays that use the linear data reduction method.
b. If the sample absorbance is greater than the extrapolation limit, flagging is applied as
described in steps 2, page 1582 through 5, page 1582.
2. The highest calibrator absorbance is used to generate a concentration value.
3. The concentration value is adjusted by the configured correlation factor and intercept.
4. The concentration is adjusted by the sample dilution factor. This value is the adjusted
concentration value.
5. The extrapolation flag is generated by using the greater-than sign (>) and reflects the
adjusted concentration value.
Table 57: Nonlinear calibration method and sample absorbance that exceeds the highest
calibrator absorbance
Sample dilution factor 1

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Linearity limit 500

Calculated concentration 500
Correlation factor 0.91
Correlation intercept 0
Adjusted concentration = [(Calculated concentration x Correlation factor) + Intercept] x Sample dilution

factor
455 = [(500 x 0.91) + 0] x 1
The extrapolation flag reflects the adjusted concentration. Thus, the sample result is reported as
> 455.
Edit general settings of assay parameters (c‑series photometric), page 286
Maximum absorbance variation (c‑series photometric)

The maximum absorbance variation (Maximum Abs Variation) parameter is designed to
evaluate the absorbance variation within the main read time. The parameter is available only if
the Reaction Mode parameter is End Up or End Down.
To perform the maximum absorbance variation check, the system software subtracts the
minimum absorbance value from the maximum absorbance value within the main read time.
When the absorbance reads vary by more than the defined limit, the result becomes an
exception and is not reported.
NOTE: The maximum absorbance variation check is not performed in the following instances:
• When the Maximum Abs Variation parameter is undefined
• When the number of valid photometric read points in the read time is less than two

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Figure 174: Example of the maximum absorbance variation (c‑series photometric)
Where:
Abs Absorbance
S Sample dispense
M Main read time
Max Maximum acceptable absorbance variation
N Example of a normal reaction
A Example of an abnormal reaction

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Maximum curve fit (c‑series photometric)

The Maximum Curve Fit parameter is a calibration validity check that uses the nominal
calibrator concentration. The parameter is available only for assays that have the Calibration
Method parameter configured as Logit-4. The parameter specifies the maximum limit of the sum
of the absolute values of the difference between the approximated absorbance of the calculated
calibration curve and the measured absorbance values. If the curve fit that is calculated for the
calibration curve is greater than the defined maximum curve fit, the calibration fails.
The curve fit is calculated by using the following formula:
Curve fit = Diffcal1 + Diffcal2 + Diffcal3 + Diffcal4 + Diffcal5 + Diffcal6
Where:
Diffcal(x) Absolute value of the difference between the measured

absorbance for Cal (x) and the absorbance calculated for Cal
(x) by using the curve
Figure 175: Maximum curve fit calculation (c‑series photometric)
Where:
Abs Absorbance
Conc Concentration

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Diffcal(x) Absolute value of the difference between the measured

absorbance for Cal (x) and the absorbance calculated for Cal
(x) by using the curve
Photometric timing table (c‑series photometric)

The following table shows conversions of photometric read points to time in seconds. The time in
seconds is then converted to minutes and seconds. Millisecond values that are greater than or
equal to 0.5 seconds are rounded to the next second:
• The time of the first photometric read point is defined at 0 seconds. Values from 1 through
38 can be configured to specify the read points that are used for data reduction.
• The second reagent dispense occurs just before read point 19.
• The first read point for use by a FlexRate read time is read point 20.
• The first read point for use by a rate assay is read point 24.
• At least one read point must be defined for an end-point assay.
• At least two read points must be defined for a rate assay.
Table 58: Photometric timing table (c‑series)
Photometric point Photometric timing Time after reagent 2 dispense

Time (s)* Time (min:s)* Time (s)* Time (min:s)*
1 0.000 0:0
2 15.976 0:16
3 31.951 0:32
4 47.927 0:48
5 63.903 1:04
6 79.879 1:20
7 95.854 1:36
8 111.830 1:52
9 127.806 2:08
10 143.782 2:24
11 159.757 2:40
12 175.733 2:56
13 191.709 3:12
14 207.685 3:28
15 223.660 3:44

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Photometric point Photometric timing Time after reagent 2 dispense

Time (s)* Time (min:s)* Time (s)* Time (min:s)*
16 239.636 4:00
17 255.612 4:16
18 271.588 4:32
19 287.563 4:48 3.100 0:03
20 303.539 5:04 19.076 0:19
21 319.515 5:20 35.051 0:35
22 335.491 5:35 51.027 0:51
23 351.466 5:51 67.003 1:07
24 367.442 6:07 82.979 1:23
25 383.418 6:23 98.954 1:39
26 399.394 6:39 114.930 1:55
27 415.369 6:55 130.906 2:11
28 431.345 7:11 146.882 2:27
29 447.321 7:27 162.857 2:43
30 463.296 7:43 178.833 2:59
31 479.292 7:59 194.809 3:15
32 495.248 8:15 210.785 3:31
33 511.224 8:31 226.760 3:47
34 527.199 8:47 242.736 4:03
35 543.175 9:03 258.712 4:19
36 559.151 9:19 274.688 4:35
37 575.127 9:35 290.663 4:51
38 591.102 9:51 306.639 5:07
* Time values greater than or equal to 0.500 seconds are rounded up to the next full second for
the purpose of conversion to minutes and seconds.
Rate linearity percent (c‑series photometric)

The Rate Linearity% (RL%) parameter is designed to evaluate the linearity of the absorbance
change within the main read time or the flex read time. The parameter is available only if the
Reaction Mode parameter is Rate Up or Rate Down and a minimum of four photometric read
points are defined in the main read time.

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To perform the RL% check, the system software evaluates the rate change that occurs during
the last three photometric read points of the configured read time and subtracts the value from
the rate change that occurs during the first three photometric read points of the configured read
time. Then, the value is divided by the rate change for all configured photometric reads and is
expressed as a percentage:
RL% = (∆Af/min - ∆Ab/min) ÷ ∆A/min x 100
Where:
∆Af/min Absorbance change per minute during the first three

configured photometric reads in the read time
∆Ab/min Absorbance change per minute during the last three

∆A/min Absorbance change per minute for all configured photometric

reads in the read time
NOTE: The RL% check is not performed in the following instances:

• When the Rate Linearity% parameter is undefined
• When the number of photometric read points in the read time is less than four
• When ∆Af/min - ∆Ab/min is 0.006 Abs/min or less
• When ∆A/min is 0.06 Abs/min or less
When the RL% exceeds the defined limit, the result becomes an exception and is not reported.

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Figure 176: Rate linearity percent calculation (c‑series photometric)
Where:
Abs Absorbance
S Sample dispense
M Main read time
∆Af/min Absorbance change per minute during the first three

∆Ab/min Absorbance change per minute during the last three

∆A/min Absorbance change per minute for all configured photometric

reads in the read time

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Reaction check (c‑series photometric)

The reaction check can be used to identify unexpected reaction performance because of the
following possible causes:
• Absorbance changes because of sample interference (hemolysis, lipemia, etc.)
• Absorbance changes because of incorrect specimen handling or collection
• Interference from an endogenous substance or a drug
• Substrate depletion because of high-analyte concentration
The reaction check uses two configured read time ranges, the A Read Time range and the B
Read Time range. The absorbance values measured during the read time ranges are measured
at the primary wavelength. The absorbance values are used to perform the selected reaction
check calculation and then are compared to the configured values for the Calculation Limits
parameter. If the Reaction Check parameter is End Ratio or Rate Ratio, the absorbance values
from the B Read Time range are also compared to the configured value for the Minimum
parameter. If the absorbance values do not fall within the configured parameters, the result
NOTE: No requirement exists for which read time must occur first. The A Read Time can
precede the B Read Time or vice versa. Additionally, the read times may overlap.
Four settings for the Reaction Check parameter determine the absorbance calculation that is
performed:
None No reaction check is performed.
End Subtraction The difference between the absorbance measured during the
A Read Time range and the B Read Time range (A - B) is
calculated.
End Ratio The ratio of the absorbance measured during the A Read
Time range and the B Read Time range (A ÷ B) is calculated.
Rate Subtraction The difference between the rate per minute measured during
the A Read Time range and the B Read Time range (A - B) is
calculated.
Rate Ratio The ratio of the rate per minute measured during the A Read
Time range and the B Read Time range (A ÷ B) is calculated.
NOTE: The reaction check is not performed if the sample is a blank calibrator or if the
parameter is undefined.

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If one of the reaction check read times starts before the addition of the second reagent, the
system corrects the measured absorbance for the sample volume and reagent volume by
multiplying the measured absorbance by the following formula:
Vs+VR1+W1
Vs+VR1+W1+VR2+W2
Where:
Vs Sample volume
VR1 Reagent 1 volume
W1 Reagent 1 water volume
Figure 177: Example of the reaction check (c‑series photometric)
Where:
Abs Absorbance
RB B read time
RA A read time

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N Normal sample
A Abnormal sample
For the example, the following reaction check settings can be configured:
• Reaction Check: End Subtraction
• A Read Time: 21 - 24
• B Read Time: 7 - 10
• Calculation Limits: 0 - 9999999
For the normal sample example, when the B Read Time absorbance is subtracted from the A
Read Time absorbance, the B Read Time absorbance is greater than zero. The value falls within
the defined limits for the calculation. Therefore, no result message code is generated.
For the abnormal sample example, when the B Read Time absorbance is subtracted from the A
Read Time absorbance, the B Read Time absorbance is less than zero. Therefore, the result
Sample dilution (c‑series photometric)
Dilution factor
In the Sample area on the General tab of the Assay Parameters screen, the Dilution Factor
parameter is displayed to two decimal places for each configured dilution. Sample results are
adjusted by the dilution factor that corresponds to the dilution protocol used for testing. The
sample dilution factor is calculated by the system and is based on the following configured
parameters:
• Sample volume
• Reagent volume
• Diluent volume
• Water volume
• The volume of the highest calibrator level
Three variables compose the calculation for the displayed sample dilution factor:
Sample dilution factor = (OD x S) ÷ SMax
Where:
OD Onboard dilution factor

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S Cuvette sample volume factor
SMax Cuvette sample volume factor of the highest calibrator level
Onboard dilution factor (OD)
OD = VD ÷ VS
Where:
VD Sample volume + Diluent volume + Water volume
VS Sample volume
NOTE: If the sample is not diluted, the onboard dilution factor is 1.
Cuvette sample volume factor (S)
S = Vcuv ÷ VSD
Where:
Vcuv Total volume in the cuvette = (Sample volume for an

undiluted sample or diluted sample volume for a diluted
sample) + Reagent 1 volume + Reagent 1 water volume +
Reagent 2 volume + Reagent 2 water volume
VSD Sample volume for an undiluted sample or diluted sample

volume for a diluted sample
Cuvette sample volume factor of the highest calibrator level (SMax)
SMax = VT ÷ VHC
Where:
VT Total volume in the cuvette of the highest calibrator level =

(Sample volume of the highest calibrator level if the volume is
undiluted or diluted sample volume of the highest calibrator
level if the volume is diluted) + Reagent 1 volume + Reagent
1 water volume + Reagent 2 volume + Reagent 2 water
volume
VHC Sample volume of the highest calibrator level if the volume is

undiluted or diluted sample volume of the highest calibrator
level if the volume is diluted

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The following example illustrates the calculation for an assay with the following
volumes:
Reagent 1 volume 28 µL
Reagent 1 water 252 µL

volume
Reagent 2 volume 28 µL
Sample volume of the 4.0 µL

highest calibrator
level
Dilution name Sample Diluted sample Diluent Water Dilution factor
(µL) (µL) (µL) (µL)
Undiluted 4.0 1:1.00
1:2 2.0 1:1.99
1:5 10.0 8.0 90 1:5.06
Dilution 1 (Undiluted):
• OD = 1
• S = (4.0 + 28 + 252 + 28 + 0) ÷ 4.0 = 78
• SMax = (4.0 + 28 + 252 + 28 + 0) ÷ 4.0 = 78
• Sample dilution factor = (1 × 78) ÷ 78 = 1.00
Dilution 2 (1:2):
• OD = 1
• S = (2.0 + 28 + 252 + 28 + 0) ÷ 2.0 = 155
• SMax = (4.0 + 28 + 252 + 28 + 0) ÷ 4.0 = 78
• Sample dilution factor = (1 × 155) ÷ 78 = 1.99
Dilution 3 (1:5):
• OD = (10.0 + 90 + 0) ÷ 10.0 = 10
• S = (8.0 + 28 + 252 + 28 + 0) ÷ 8.0 = 39.5
• SMax = (4.0 + 28 + 252 + 28 + 0) ÷ 4.0 = 78
• Sample dilution factor = (10 × 39.5) ÷ 78 = 5.06

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Self blank (c‑series photometric)

Sample interference indices such as lipemia, hemolysis, and icterus can add color to samples
that are measured with photometric reactions. If the Sample Blank Types parameter is
configured as Self Blank, the absorbance values of samples with color can be corrected for the
coloring.
To perform the self blank, the blank read time must be configured for the assay. The self blank
is performed during the configured blank read time in the same cuvette as the assay
measurement.
If the blank read time starts before the addition of the second reagent, the system corrects the
absorbance measured during the blank read time for the sample volume and reagent volume,
and then uses the following formula to subtract this value from the absorbance value.
Vs+VR1+W1
A = Ai − Vs+VR1+W1+VR2+W2
× Ab
Where:
A Absorbance or absorbance change after the blank correction
Ai Absorbance or absorbance change that occurs during the

main read time
Ab Absorbance or absorbance change that occurs during the

blank read time
Vs Sample volume
NOTE: If the sample blank measurement is performed after the addition of the second reagent,
the system does not correct the measured absorbance for the sample volume and reagent
volume. The system uses the following formula:
A = Ai - Ab

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Figure 178: Example of a reaction graph with a blank read time
Where:
Abs Absorbance
S Sample dispense
B Blank read time
M Main read time

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Calculate a calibration factor (c‑series photometric)

Prerequisite Data from at least 10 successful assay calibrations performed
with several different reagent lot numbers and calibrator lot
numbers is recommended. Quality control results for the
candidate calibrations need to meet the acceptance criteria
defined by the laboratory and should not display trends or
shifts.
A preliminary calibration factor can be estimated with data
from three or four calibrations and then can be revised when
the data set is completed.
Perform this procedure to determine a c‑series photometric calibration factor.

The Expected Cal Factor parameter and the Expected Cal Factor Tolerance % parameter are
used to define a range for the calibration factor validity check. After the calibration factor range
is established, if the actual calibration factor is not within the defined range, the calibration fails.
The following message code is generated, where 0 is the assay name and 1 is the assay
number: 1605 Calibration failed for assay (0) number (1). Calibration factor out of range.
The following graph demonstrates the feature for a linear assay where the expected calibration
factor is 50 and the expected calibration factor tolerance percent is 20. The system evaluates
each section of the calibration to determine whether the calibration factor is from 40 through 60.
Where:

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Abs Absorbance
Conc Concentration
Actual calibration factor
Expected calibration factor
Expected calibration factor tolerance %
1. To determine the expected calibration factor, calculate the average calibration factor from
the calibration data.
NOTE: All sections of a calibration are evaluated for assays that have the Calibration
Method parameter configured as Linear. Calculate the average by using the data from all
sections of all calibrations to determine the expected calibration factor.
Only the first section of the calibration is evaluated for an assay that has the Calibration
Method parameter configured as Spline. Calculate the average by using the data from only
the first section of all calibrations to determine the expected calibration factor.
2. In the Expected Cal Factor text box, type the average calibration factor.
3. In the Expected Cal Factor Tolerance % text box, type a value.
4. To confirm the parameters entered in steps 2, page 1598 and 3, page 1598, monitor the
calibration factor values and quality control results for successive calibrations.
5. To adjust the calibration factor and the expected calibration factor tolerance percent as
additional reagent and calibrator lots are analyzed over time, repeat steps 1, page 1598
through 4, page 1598.
NOTE: The calibration factor tolerance percent may require an adjustment if the calibration
fails, the expected calibration factor is correct, and the quality control values are within the
acceptance criteria defined by the laboratory.
Create a user-defined assay (c‑series photometric)

status
Perform this procedure to create a c‑series photometric user-defined assay. A user-defined

assay has an assay number from 2000 through 2999.

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NOTE: The system count for user-defined assays is determined by the number of configured
user-defined reagents. The system software automatically deletes user-defined reagents when
no cartridges are present for the reagent and no assay is configured to use the reagent.
4. On the Assay Parameters screen, tap Create.
5. In the Create Assay flyout, tap Photometric, and then tap Done.
6. On the General tab of the Assay Parameters screen, configure the following settings:
a. In the Assay Name text box, type the name of the assay.
The next available assay number is displayed in the Assay Number text box.
b. If an alternate assay number is needed, type a number from 2000 through 2999 in the
Assay Number text box.
c. In the Assay Availability drop-down list, tap an item.
NOTE: If the Enabled setting is selected, the setting is not retained after the assay
parameter is saved until the calibrator values are defined for assays that require a
calibrator set.
d. In the Module area, tap the module number check boxes for the modules that are
allocated to load the reagent of the assay.
NOTE: This parameter is available only if the Alinity ci‑series is configured with more
than one processing module of the same type.
e. In the Run Controls for Onboard Reagents by drop-down list, tap an item.
f. In the Reaction Definition area, enter the information.
g. In the Validity Checks area, enter the information.
h. In the Sample area, enter the information.
i. To configure a new reagent, tap New Reagent.
j. In the New Reagent flyout, enter the information, and then tap Done.
The new reagent name is displayed in the Reagent drop-down list in the Reagent area.
k. If a new sample diluent needs to be configured, repeat steps 6.i, page 1599 and 6.j,
page 1599.
The new sample diluent name is displayed in the Diluent drop-down list in the Reagent
area.
l. In the Reagent area, configure the remaining settings.
7. Tap the Calibration tab, and then configure the following settings:

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a. In the Calibration area, enter the information.

b. To configure a new calibrator set, tap New Cal Set, enter the information in the New
Cal Set flyout, and then tap Done.
c. In the Calibrators area, enter the information.
d. In the Validity Checks area, enter the information.
e. To save the general and calibration assay parameter settings, tap Save.
8. Tap the Results tab, and then configure the following settings:
a. In the Result Units area, enter the information.
b. If the Result Units parameter is edited, tap Save to update the displayed result values
to the new unit.
c. Under Results, type a value in the Low Linearity text box.
d. In the High Linearity text box, type a value.
e. To configure a result range, tap Add Result.
f. In the Add Result flyout, enter the information.
g. Tap Done.
h. To complete the result range configuration, repeat steps 8.f, page 1600 and 8.g, page
1600.
i. To configure an interpretation range, under Interpretation, tap an interpretation in the
Name drop-down list.
NOTE: If <UserDefined> is selected, type the name of the interpretation in the Name
text box.
j. In the Range text box, type an interpretation range value.
k. For the appropriate interpretation, tap the Review Required check box.
release when the Hold option is configured for the Result Release Mode and the results
are within the specific interpretation range.
l. To configure additional interpretation range settings, repeat steps 8.j, page 1600 and
8.k, page 1600.
9. Tap the Retest Rules tab, and then configure the following settings:
a. In the Retest Rule Name text box, type a name.
b. If the criteria is based on result ranges, tap Result Range in the Result Indicator area,
and then perform one of the following steps to enter a range:

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c. If the criteria is based on interpretations, tap Interpretation in the Result Indicator
area.
d. In the Interpretation drop-down list, tap an interpretation.
e. If the criteria is based on exceptions, tap Exception in the Result Indicator area.
• 1037 Unable to calculate result. Rate reaction linearity failure.
• 1038 Unable to calculate result. Insufficient absorbance reads within absorbance
range.
• 1039 Unable to calculate result. Absorbance exceeded optical limits.
• 1040 Unable to calculate result. No absorbance reads within absorbance range.
• 1041 Unable to calculate result. Reaction check failure.
• 1042 Unable to calculate result. ICT reference solution voltage drift error.
• 1043 Unable to calculate result. Final RLU read is outside the specification of the
highest calibrator.
• 1044 Unable to calculate result. Final RLU read is outside the specification of the
lowest calibrator.
• 1402 Unable to process test. Activated read failure.
• 1403 Unable to process test. Final read failure.
f. In the Original Dilution drop-down list, tap an original dilution.
g. Tap Retest Assays.
h. In the Retest Assays flyout, tap one or more retest assays.
Calculated.
i. To save the retest assay selection, tap Done.
j. Under Retest Dilution, tap a retest dilution in the Retest Dilution drop-down list for
each assay.
k. Under Replicates, tap the number of replicates in the Replicates drop-down list for
each assay.

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l. To add additional retest assays, repeat steps 9.g, page 1601 through 9.k, page 1601.
m. Tap Add Rule to add the retest rule.
n. To configure additional retest rules, repeat steps 9.a, page 1600 through 9.m, page
1602.
10. Tap the SmartWash tab, and then configure the following settings:
a. In the Virtual Line drop-down list, tap one of the following items:
• Both: The assay does not require separation from another assay and can use Line
A or Line B cuvettes.
• Line A: The assay uses only the odd-numbered cuvettes.
• Line B: The assay uses only the even-numbered cuvettes.
b. Under Define SmartWash, tap an option in the Component area.
c. In the Interfering Reagent list, tap the name of the reagent that interferes with the
assay.
NOTE: This list is unavailable if the Sample Probe component option was selected.
d. In the Wash Solution drop-down list, tap an item.
e. In the Wash Volume text box, type a wash volume value.
NOTE: This text box is unavailable if the Sample Probe component option was
selected.
f. In the Replicates drop-down list, tap a number.
NOTE: This drop-down list is unavailable if the Cuvette or Sample Probe component
option was selected.
g. Tap Add SmartWash to add the SmartWash to the SmartWash Information area.
h. To complete the SmartWash settings, repeat steps 10.a, page 1602 through 10.g, page
1602.

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Perform an initial user-defined assay run (c‑series)

Prerequisite Confirm that a reagent cartridge filled with the user-defined
reagent and labeled with a 1D reagent bar code is loaded in
Required materials • Calibrators
• Quality control material
Perform this procedure to evaluate user-defined assay parameters.

1. Create a calibration order and perform a calibration for the new assay:
– If the calibration results are acceptable, proceed to step 9, page 1604.
– If the calibration results are unacceptable, proceed to step 2, page 1603.
2. Determine whether other assays can be successfully calibrated on the same processing
module:
– If other assay calibration results are acceptable, proceed to step 3, page 1603.
– If other assay calibration results are unacceptable, investigate and resolve any
instrument issues, and then repeat step 1, page 1603.
3. Perform the following troubleshooting steps for the new assay and resolve any issues:
a. Confirm that the reagent preparation was performed according to the assay
documentation.
b. Verify that the configured calibrator concentrations are correct.
c. Confirm that the calibrators are loaded in the correct order and have sufficient volume
for testing.
If issues were identified and resolved, repeat step 1, page 1603.

If issues were not identified, proceed to step 4, page 1603.
4. Change the Calibration Method parameter setting to Absorbance.
5. Create a single specimen order to test each calibrator sample as a specimen.
6. Review the reaction graph and the Absorbance Data Report for each calibrator sample
result.
7. Based on the review of the calibrator sample result data, edit the following assay
parameters if indicated:
– Calibration method

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– Calibration validity checks

– Photometric read times
– Volumes
– Wavelengths
8. After the assay parameters have been edited, confirm that the Calibration Method
parameter setting is not Absorbance, and then repeat step 1, page 1603.
9. To perform quality control testing, create a single specimen order for each quality control
sample:
– If the quality control results meet the acceptance criteria defined by the laboratory, the
initial assay run is completed. Perform a reagent carryover evaluation and assay
verification testing as indicated by the laboratory standard operating procedure.
– If the quality control results do not meet the acceptance criteria defined by the
laboratory, review the reaction graph and the Absorbance Data Report for each result.
Repeat quality control testing. If the quality control results still do not meet the
acceptance criteria defined by the laboratory, contact the assay vendor for assistance.

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Appendix C Reagent carryover evaluation (c‑series)
Reagent carryover evaluation (c‑series)

Reagent carryover studies need to be performed as part of the routine evaluation and integration
of user-defined assays on the c‑series. Identification of reagent carryover allows the operator to
take the appropriate precautions (for example, use of the SmartWash feature) to ensure that
reliable results are obtained.
NOTE: The effectivity of SmartWashes that are implemented as a result of a reagent carryover
evaluation needs to be confirmed by repeating the evaluation. Based on the results, a different
wash solution may need to be selected and tested.
A reagent carryover evaluation may also be performed as a corrective action to resolve message
codes and sample results observed problems on the c‑series.
Edit SmartWash settings (c‑series), page 1610
Perform a reagent carryover evaluation (c‑series)

Prerequisite Confirm that the donor and recipient assays have an active
calibration, the assays have a reagent cartridge loaded in the
reagent carousel, and control values for the assays are within
the acceptable range.
Required materials Control material that has a laboratory-established control

range for the recipient assay
Perform this procedure to determine if reagent carryover is present in the following instances:
• Between the reagent of a new assay application and the reagents of the current assay
menu
• Between the reagents of existing assay pairs
Use the following definitions of assay types:

Recipient assay An assay whose results may be affected by reagent carryover
from another assay
Donor assay An assay that may contribute reagent carryover into
subsequent assays
NOTE: Each assay pair needs to be evaluated as both a donor assay and a recipient assay.

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Reagent carryover evaluation (c‑series) Appendix C
1. Identify the assay pair to be evaluated.

2. Print the Assay Parameter Report for the donor and recipient assays to retain the current
SmartWash settings.
3. Create the following specimen order.
NOTE: Alternate sequential SIDs can be used.
R/P SID Assay Replicates Description
1/1 99001 Recipient 5 Baseline recipient assay replicates. The mean
assay value of these replicates determines the baseline
mean value for the recipient assay.
1/2 99002 Donor assay 1 Donor assay challenge 1
1/3 99003 Recipient 1 Recipient assay result after challenge 1
assay
1/4 99004 Donor assay 1 Donor assay challenge 2
1/5 99005 Recipient 1 Recipient assay result after challenge 2
assay
4. Load five sample cups of the control material in a sample rack.

NOTE: The same control level needs to be used for each of the recipient samples in an
order.
5. Load the sample rack on the reagent and sample manager and initiate sample processing.
6. Wait until sample processing is completed.
8. On the Results screen, if the patient and control release modes are configured as automatic
or automatic with exceptions, tap the Specimen tab.
If the patient and control release modes are not configured as automatic or automatic with
exceptions, proceed to step 9, page 1606.
9. Tap Search.
10. In the Search flyout, perform the following steps:
a. Tap a Module check box.
b. In the SID text box, type 9900 or the first four digits of the SID.
c. In the Date From and To text boxes, enter the current date.
d. To display the assay results, tap Done.
11. Determine the baseline mean, which is the mean of the baseline recipient assay replicates
for SID 99001 or the alternate SID.

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12. Ensure that the percent coefficient of variation (%CV) for the baseline recipient assay
replicates meets the precision claim for the assay.
13. If the %CV does not meet the precision claim, perform the following steps:
a. Troubleshoot the system to resolve the issue.
b. Repeat the run request described in step 3, page 1606 until the %CV for the results is
within the precision claim.
14. Review the recipient assay results after the donor assay challenges for SID 99003 and SID
99005 or for the alternate third and fifth SIDs.
15. Determine whether the recipient assay results are elevated or decreased when compared to
the baseline mean:
– If reagent carryover is present, the recipient assay results after the donor assay
challenges will not match the baseline mean.
– If reagent carryover is not present, the recipient assay results after the donor assay
challenges will closely agree with the baseline mean.
NOTE: No specific value defines the acceptance criteria for the difference or percent
difference from the baseline mean. Laboratories can establish acceptance criteria
based on their individual laboratory needs. The total allowable error for the recipient
assay may be used as a guideline for acceptable assay bias.
Alternatively, the imprecision claim and the clinically relevant bias of the recipient assay
may be used to establish the acceptance criteria.
16. If the difference from the baseline mean exceeds the acceptance criteria, configure and
verify the SmartWash settings.
17. If the difference from the baseline mean is within the acceptance criteria, repeat the reagent
carryover evaluation for the assay pair by testing the recipient assay as the donor assay.
18. If the reagent carryover evaluation tested the reagent for a new assay application, continue
testing with the new reagent until the evaluation of the current assay menu is completed.
The following information is provided as an example and is not intended to

illustrate actual results.
No carryover observed
SID Assay Result
99001 Recipient assay 31
Recipient assay 31
Recipient assay 31
Recipient assay 31
Recipient assay 31
Recipient assay 31
Recipient assay 31

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SID Assay Result

99002 Donor assay 68.2
Carryover observed
SID Assay Result
Recipient assay 31
Recipient assay 31
Recipient assay 31
Recipient assay 31
Recipient assay 31
Recipient assay 31
Configure and verify SmartWash settings (c‑series)

status
The SmartWash feature provides an additional wash for the reagent probes, sample probe, and
cuvette to prevent assay-to-assay interference.
Perform this procedure to configure and verify the following settings:
• SmartWash settings for user-defined assays
• Additional SmartWash settings for a c‑series photometric or potentiometric assay

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NOTE: Consider the following information when SmartWash settings are configured:
• The assay parameters of an assay with a pending order cannot be edited.
• Only one wash solution needs to be configured for each component. The system uses only
one configured wash solution for each component.
• SmartWash settings are performed in the order in which they are configured.
• Reagent probe settings that use the All setting need to be configured last.
• User-defined SmartWash parameters are retained unless additional SmartWash parameters
are included with an assay file revision.
• The effectivity of the new settings to reduce assay-to-assay interference needs to be
evaluated.
Based on internal testing, the following guidelines can be used to select a wash solution to use
for SmartWash settings:
• Water may be adequate for removing any soluble salts.
• Alkaline wash solutions, such as Detergent A and Detergent B, are more effective than
water or Acid Probe Wash for removing any proteins, latex particles, and contaminants that
enhance viscosity.
• Acid Probe Wash is more effective than alkaline wash solutions or water for removing any
metal contaminants or their salts.

5. Tap View/Edit.
6. Tap the SmartWash tab.
7. In the Virtual Line drop-down list, tap one of the following items:
– Both: The assay does not require separation from another assay and can use Line A or
Line B cuvettes.
– Line A: The assay uses only the odd-numbered cuvettes.
– Line B: The assay uses only the even-numbered cuvettes.
8. Under Define SmartWash, tap one of the following options in the Component area:
– Reagent Probe R1
– Reagent Probe R2

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– Cuvette
– Sample Probe
9. In the Interfering Reagent list, tap the name of the reagent that interferes with the selected
assay.
10. In the Wash Solution drop-down list, tap an item.
11. In the Wash Volume text box, type a wash volume value.
NOTE: This text box is unavailable if the Sample Probe component option was selected.
12. In the Replicates drop-down list, tap a number.
NOTE: This drop-down list is unavailable if the Cuvette or Sample Probe component option
was selected.
13. Tap Add SmartWash to add the SmartWash to the SmartWash Information area.
14. If a SmartWash is needed for another component, repeat steps 8, page 1609 through 13,
page 1610.
Edit SmartWash settings (c‑series)

status
The SmartWash feature provides an additional wash for the reagent probes, sample probe, and
cuvette to prevent assay-to-assay interference.
Perform this procedure to edit the following settings:
• SmartWash settings for user-defined assays

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• Additional SmartWash settings that were configured for a c‑series photometric or

potentiometric assay
NOTE: Consider the following information when SmartWash settings are edited:
• The assay parameters of an assay with a pending order cannot be edited.
• Abbott-provided SmartWash settings cannot be edited.
• Only one wash solution needs to be configured for each component. The system uses only
one configured wash solution for each component.
• SmartWash settings are performed in the order in which they are configured.
• Reagent probe settings that use the All setting need to be configured last.
• User-defined SmartWash parameters are retained unless additional SmartWash parameters
are included with an assay file revision.
• The effectivity of the new settings to reduce assay-to-assay interference needs to be
evaluated.
Based on internal testing, the following guidelines can be used to select a wash solution to use
for SmartWash settings:
• Water may be adequate for removing any soluble salts.
• Alkaline wash solutions, such as Detergent A and Detergent B, are more effective than
water or Acid Probe Wash for removing any proteins, latex particles, and contaminants that
enhance viscosity.
• Acid Probe Wash is more effective than alkaline wash solutions or water for removing any
metal contaminants or their salts.

5. Tap View/Edit.
6. Tap the SmartWash tab.
7. In the Virtual Line drop-down list, tap an item to change the virtual line setting.
NOTE: This step is performed only for user-defined assays.
8. Under SmartWash Information, tap a SmartWash to edit.
9. Tap Delete SmartWash to delete a configured SmartWash or to edit the option in the
Component area.

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10. In the Interfering Reagent list, tap the name of the reagent that interferes with the selected
assay.
11. In the Wash Solution drop-down list, tap an item.
12. In the Wash Volume text box, type a wash volume value.
NOTE: This text box is unavailable if the Sample Probe component option was selected.
13. In the Replicates drop-down list, tap a number.
NOTE: This drop-down list is unavailable if the Cuvette or Sample Probe component option
was selected.
14. Tap Add SmartWash to add the edited SmartWash to the SmartWash Information area.
15. If a SmartWash is needed for another component, repeat steps 8, page 1611 through 14,
page 1612.

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Appendix D Printed report element descriptions
Introduction
Printed report element descriptions describe the information that is printed on individual reports.
NOTE: Items are printed on the reports in the order in which they are displayed on the screen.
Absorbance Data Report element descriptions (c‑series), page 1614
Assay Information Report element descriptions, page 1617
Assay Installation Report element descriptions, page 1618
Assay Parameter Report element descriptions (c‑series), page 1619
Assay Parameter Report element descriptions (i‑series), page 1632
Assay Parameter Report (Calculated) element descriptions , page 1638
Calibration Details Report (Linear) element descriptions (c‑series), page 1642
Calibration Details Report (Potentiometric) element descriptions (c‑series), page 1645
Calibration Details Report (Use Cal Factor Blank) element descriptions (c‑series), page 1648
Calibration Details Report (Adjust) element descriptions (i‑series), page 1651
Calibration Details Report (Full) element descriptions (i‑series), page 1654
Calibration Details Report (Index) element descriptions (i‑series), page 1657
Calibration Summary Report element descriptions, page 1660
Diagnostic History Report, Maintenance History Report element descriptions, page 1661
Exception List Report element descriptions, page 1664
Log Report element descriptions, page 1666
QC Analysis Report element descriptions, page 1673
QC Levey-Jennings Report element descriptions, page 1676
QC Summary Report element descriptions, page 1679
System Update Details Report element descriptions, page 1693
System Update List Report element descriptions, page 1696
User-Defined Maintenance Details Report element descriptions, page 1698

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Printed report element descriptions
Absorbance Data Report element descriptions (c‑series) Appendix D
Absorbance Data Report element descriptions

(c‑series)
The Absorbance Data Report contains information about the absorbance data obtained for
unreleased and released test results. The report can be printed and used as a record of
absorbance data for the laboratory.
Report Header area
Operator ID Prints the identification of the operator logged onto the system
when the report was printed.
SN Prints the serial number of the system control module.
Site Prints the configured facility name.
Software Version Prints the system software version at the time that the report
was printed.
System Name Prints the configured system name.
Elements
Assay Name Prints the name of the assay file.
Sample ID Prints the sample identification.
Assay Number Prints the number of the assay file.
Name Prints the name, which can be one of the following items:
Assay Version Prints the version of the assay file.
Module/SN Prints the module number and serial number of the module
used to process the test.

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Appendix D Absorbance Data Report element descriptions (c‑series)
Results area
R/P Prints the rack ID (R) and position (P) number.

printed as LAS/1.
Result Prints the value and unit of the result.
Interpretation Prints the interpretation of the result value obtained.
Flags Prints the flags associated with the result.
Code Prints the processing codes associated with the test.
Cuvette Prints the number of the cuvette used to process the test.
Primary Wavelength Prints the primary wavelength used to measure the assay
concentration.
Secondary Prints the secondary wavelength used to measure the assay

Wavelength concentration.
Point Prints the photometric read points that define the read times.
Numbers 1 through 38 may be printed.
Primary Prints the absorbance value measured at the primary

wavelength for each photometric read point.
Secondary Prints the absorbance value measured at the secondary

wavelength for each photometric read point.
Primary - Secondary Prints the difference between the absorbance values

measured at the primary and secondary wavelengths.
B-B Prints the photometric read points defined as the blank read
time for the assay.
F-F Prints the photometric read points defined as the flex read
time for the assay.
M-M Prints the photometric read points defined as the main read
time for the assay.

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Absorbance Data Report element descriptions (c‑series) Appendix D
Printed report element descriptions, page 1613

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Appendix D Assay Information Report element descriptions
Assay Information Report element descriptions

The Assay Information Report contains a list of the currently installed assays. The report can be
printed and used as a record of installed assays for the laboratory.
Report Header area
was printed.
Elements
Assay Name Prints the assay name.
Dilution 1 through Prints the specific information for each defined dilution in the
Dilution 6 assay file.

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Assay Installation Report element descriptions Appendix D
Assay Installation Report element descriptions

The Assay Installation Report contains a list of assay specification information for the currently
installed assays. Module-specific installation instructions are included before the list. Multiple
assay files can be selected for the report. The report can be printed and used as a record of
installed assays for the laboratory.
Report Header area
was printed.
Assay Specification Information area
List Number Prints the list number of the assay file.
Assay changes Prints special instructions for each assay and the assay
approval date.
NOTE: The Assay changes header is not displayed or printed
for this element.

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Appendix D Assay Parameter Report element descriptions (c‑series)
Assay Parameter Report element descriptions

(c‑series)
The Assay Parameter Report contains the parameters for selected c‑series assays. The report
can be configured to print automatically.
Report Header area
when the report was printed or the last operator logged onto
the system for automatically generated reports.
was printed.
General Parameters area
Assay Type Prints one of the following assay protocol types:

• Photometric
• Potentiometric
• Hemolysis
• Icterus
• Lipemia
• Calculated
Assay Number Prints the number assigned to the assay file. The assay
number must be the same number used for a host computer.

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Assay Parameter Report element descriptions (c‑series) Appendix D
Assay Availability Prints the availability of the assay for ordering. The following
settings may be printed:
• Enabled
• Disabled
• Patient Disabled
Assay Status Prints the assay status defined for the assay. The following
• Primary
• Correlation
Date/Time Prints the date and time that an operator installed the assay
or an operator last modified the assay parameters.
Run Controls for Prints the setting used to specify which reagent cartridge to
Reagents By run for quality control. The following settings may be printed:
• Lot: Runs the controls only on one cartridge for each lot
loaded on the reagent carousel.
• Cartridge: Runs the controls for all cartridges and for
each lot loaded on the reagent carousel.
Operator Prints the identification of the operator who installed the assay
or the operator who last modified the assay parameters.
Virtual line Prints the cuvette setting used for assay processing. Assays
that interfere with each other can be assigned to separate
virtual lines to avoid interference. The following settings may
be printed:
• Line A: Only the Line A cuvettes (odd-numbered cuvettes)
are used for assay processing.
• Line B: Only the Line B cuvettes (even-numbered
cuvettes) are used for assay processing.
• Both: Both the Line A and Line B cuvettes are used for
assay processing.
Module ID Prints the numbers of the processing modules that are


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Reaction Mode Prints the type of reaction that occurs for the assay. The
following settings may be printed:
• End Up
• End Down
• Rate Up
• Rate Down
Main Read Time Prints the starting and ending photometric read points used
for data reduction.
Absorbance Range Prints the lower and upper absorbance limits for the assay. All
photometric readings need to fall within the absorbance limits
if the limits are defined. Any absorbance value that is
absorbance limits during the main or the flex read time is not
used to calculate the result.
Primary Wavelength Prints the primary wavelength used to measure the assay
concentration.
Flex Read Time Prints the starting and ending photometric read points used
for data reduction when one read or no reads performed
during the main read time fall within the configured
absorbance range.
Results that are calculated by using the absorbance data
obtained from the flex read time are identified with a FLEX
result flag.
NOTE: This parameter is available only for rate assays.
Sample Blank Type Prints the assay blank type. The following settings may be
printed:
• No Blank
• Self Blank
Secondary Prints the secondary wavelength used to measure the assay

Wavelength concentration.
Blank Read Time Prints the starting and ending photometric read points that
define the blank read time.

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NOTE: This parameter is available only when the Sample

Blank Types parameter is Self Blank.
Blank Assay Prints the name of the reference assay to use as a blank.
This functionality is currently not available.
Last Read Required Prints the last photometric read point required for result
calculation. Absorbance data is not collected for photometric
read points that occur after the configured value.
Color Correction Read Prints the starting and ending photometric read points used to
Time adjust the absorbance range limits based on the measured
sample color.
Reagent/Sample area
Reagent Prints the reagent name used for the assay.
R1 Reagent Volume Prints the reagent 1 (R1) volume that is dispensed into the
cuvette.
R2 Reagent Volume Prints the reagent 2 (R2) volume that is dispensed into the
cuvette.
Diluent Name Prints the sample diluent name used for the assay.
R1 Water Volume Prints the water volume dispensed with an R1 concentrated

reagent.
R2 Water Volume Prints the water volume dispensed with an R2 concentrated

reagent.
Diluent Dispense Prints the reagent-pipetting profile the system uses to aspirate
Mode and dispense diluents. The following settings may be printed:
• Type 1
• Type 2
• Type 6
R1 Dispense Mode Prints the reagent-pipetting profile the system uses to aspirate
and dispense reagents. The following settings may be printed:
• Type 1
• Type 2

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• Type 6
R2 Dispense Mode Prints the reagent-pipetting profile the system uses to aspirate
and dispense reagents. The following settings may be printed:
• Type 1
• Type 2
• Type 5
Default Dilution Prints the dilution protocol used as the default for sample
orders. A system administrator can edit this parameter for
non-user-defined assays when more than one dilution name is
configured.
Dilution Name Prints the assay dilution name. A maximum of three dilution
names can be configured.
Sample Volume Prints the sample volume to aspirate from the sample cup or
tube for each configured assay dilution.
Diluted Sample Prints the diluted sample volume to aspirate from the cuvette
Volume for each configured assay dilution.
Diluent Volume Prints the sample diluent volume to dispense into the cuvette
for each configured assay dilution.
Water Volume Prints the water volume to dispense into the cuvette for each
configured assay dilution.
Dilution Factor Prints the sample dilution factor that is calculated by the
Reaction Check Type Prints the reaction type used to evaluate unexpected reaction
performance. The following settings may be printed:
• None
• End Subtraction
• End Ratio
• Rate Subtraction

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• Rate Ratio

Read Time A Range Prints the starting and ending photometric read points for the
A Read Time range used for the reaction check.
Calculation Limit Prints the lower and upper limits for the acceptable range of
the calculated read time difference (A - B) or the calculated
read time ratio (A ÷ B). If the calculated value exceeds the
limits, the assay result becomes an exception and is not
processed.
Minimum Absorbance Prints the minimum acceptable absorbance or absorbance

change during the B Read Time range.
Check parameter is End Ratio or Rate Ratio.
Read Time B Range Prints the starting and ending photometric read points for the
B Read Time range used for the reaction check.
Rate Linearity% Prints the allowable percentage change in absorbance. The

check is performed during the main read times and the flex
read times by using the first three reads and the last three
reads.
times.
Maximum Absorbance Prints the acceptable absorbance variation allowed for

Variation absorbance readings during the main read time. When the
absorbance variation exceeds the defined limit, the assay
result becomes an exception and is not processed.
Mode parameter is End Up or End Down.

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Calibration Parameters area
Calibration Method Prints one of the following calibration methods:

• Absorbance
• Factor
• Linear
• Logit-4
• Spline
Full Interval Hours Prints the amount of time in hours that the full calibration
curve is valid after a full calibration is completed. The value
cannot be edited to a value greater than the number of hours
specified in the released assay file.
Adjust Interval Hours Prints the amount of time in hours that the adjust calibration is
valid after an adjustment calibration is completed. A value
from 0 through 9999 can be configured. If 0 is configured, the
adjust calibration interval is not tracked.
parameter is None.
Factor Prints the calibration factor when the Calibration Method

parameter is Factor.
Adjust Type Prints the type of adjust calibration performed for the assay.
The following settings may be printed:
• None
• Blank
• 1-Point
• 2-Point

Method parameter is Linear, Spline, or Logit-4.
Adjust Level Prints the calibrator level to use for the 1-Point and 2-Point
adjust calibration types. The configured levels for the
calibrator set are used to configure this parameter.

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Use Cal Factor From Prints the assay to reference for calibration information used
in result calculation.
NOTE: This parameter is printed only when the Calibration
Method parameter is Use Cal Factor Blank.
Maximum Curve Fit Prints the parameter for maximum curve fit. This parameter
specifies the maximum limit of the sum of the absolute values
of the difference between the approximated absorbance of
the calculated calibration and the measured absorbance. A
value from 0.0001 through 9.9999 can be configured or this
parameter can be undefined.
Default Ordering Type Prints the default calibration type used to create calibration
orders for the assay.
parameter is None.
Expected Cal Factor Prints the target value for the calibration factor (1/slope)
when the calibration is calculated. A value from -999999.99
through 9999999.99 can be configured.
method, only the first segment of the curve is evaluated.
Blank Absorbance Prints the lower and upper limits that define an acceptable
Range blank absorbance value measured during calibration:
• Lower limit: A value from -9.9999 through 9.9998 can be
• Upper limit: A value from -9.9998 through 9.9999 can be

performed.

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Expected Cal Factor Prints the percent tolerance of the calibration factor that is
Tolerance % expected when the calibration is calculated. This parameter is
used with the Expected Cal Factor parameter to determine an
acceptable range for the calibration factor. A value from 1
through 99 can be configured or this parameter can be
undefined.
method, only the first segment of the curve is evaluated.
Span Prints the calibrator level used as the upper limit of the
calibration span that is evaluated for the Span Absorbance
Range check. This parameter can be configured as one of
the calibrator levels defined for the assay or can be
undefined.
span.
Span Absorbance Prints the lower and upper limits that define an acceptable
Range absolute absorbance difference between the blank and the
defined calibrator level during calibration:
• Lower limit: A value from 0.0001 through 9.9998 can be
• Upper limit: A value from 0.0002 through 9.9999 can be

In-Use Stability Prints the maximum time in hours that the calibrator can be
(Hours) used on the processing module without refrigerated storage.
In-use stability is not tracked if a value is not configured.
Calibrator Set Name Prints the name of the selected calibrator set.

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calibrator set name is printed first, followed by the blank
calibrator set name.
NOTE: This parameter is not printed when the Calibration
Replicates Prints the number of replicates to run for the blank and each
configured calibrator level for assay calibration.
Cal Level Prints the name of the blank and prints a maximum of six
calibrator levels used as points in the calibration.
NOTE: This parameter is not printed when the Calibration
Concentration Prints the concentration value for each calibrator level defined
in the assay parameters. Only the default units are printed.
Sample Volume Prints the sample volume dispensed into the cuvette for the
blank and for each configured calibrator level.
Diluted Sample Prints the diluted sample volume for the blank and for each
Volume configured calibrator level. The diluted sample volume is
dilution protocol is defined for the calibrator.
Diluent Volume Prints the diluent volume for the blank and for each
protocol is defined for the calibrator.
Water Volume Prints the water volume used to dilute a concentrated diluent
for the blank and for each configured calibrator level. The
water volume is dispensed with any aspirated diluent into the
cuvette for dilution during calibration if a dilution protocol is
defined for the calibrator.
Smart Wash area
Component Prints the hardware component used for the configured

SmartWash. The following components may be printed:

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• Cuvette
• Sample Probe
Reagent/Assay Prints the reagent name of the interfering reagent.

NOTE: This parameter is not printed when the Component
Wash Prints the wash solution used for the configured SmartWash.
The following wash solutions may be printed:
• Detergent A
• Detergent B
• Acid Probe Wash
• Water
Volume Prints the volume of wash solution used for the configured
SmartWash.
NOTE: This parameter is not printed when the Component
Replicates Prints the number of replicates for the configured SmartWash

for the Reagent Probe R1 component or the Reagent Probe
R2 component.
Wash Protocol Prints the SmartWash protocol type.
Results Parameters area
Linearity Range Prints the configured linearity range.
Flag Range Prints the flag range associated with the results:
Specifications
Gender Prints the gender for the configured
result flags.
Age Prints the age range and unit for the

configured result flags.
Normal Range Prints the normal range for the

configured gender and age range.

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Extreme Range Prints the extreme range for the

Interpretation Parameters area
Name Prints the interpretation name. If an interpretation is not

configured, <NotDefined> is printed.
Range Prints the range for the interpretation.
Results Review Prints Yes or No to indicate whether the results are held until
Required they are reviewed and released manually.
Result Units area
Result Units Prints the configured result unit.
Correlation Factor Prints the configured correlation factor if results require a

calculation to match another system.
UCUM Prints the Unified Code for Units of Measure (UCUM). The
computers.
Decimal Places Prints the number of decimal places displayed for a result.
Intercept Prints the configured intercept if results require a calculation

to match another system.
Retest Rules area
Rule Name Prints the retest rule name.
Result Indicator Prints one of the following settings:

• Result Range: Retest criteria based on result ranges.

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• Interpretation: Retest criteria based on interpretations.

• Exception: Retest criteria based on exceptions.
Original Dilution Prints the dilution for the original test. The original test must
be run at this dilution to be considered for retesting.
NOTE: This element is unavailable for calculated assays.
Result Range Prints the result range for the configured retest rule. This
element is printed if the Result Indicator parameter is Result
Range.
Retest Assay Prints the retest assay name.
Retest Assay Number Prints the retest assay number.
Retest Dilution Prints the retest dilution for the specific retest assay.
Replicates Prints the number of replicates for the specific retest assay
and dilution.

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Assay Parameter Report element descriptions (i‑series) Appendix D
Assay Parameter Report element descriptions

(i‑series)
The Assay Parameter Report contains the parameters for selected i‑series assays. The report
Report Header area
was printed.
Assay Type Prints one of the following assay protocol types:

• One Step 25
• Two Step 18-4
• One Step 11
• Two Step 4-4

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Appendix D Assay Parameter Report element descriptions (i‑series)
• Enabled
• Disabled
Assay Status Prints the assay status defined for the assay. The following
• Primary
• Correlation
Date/Time Prints the date and time that an operator installed the assay
or an operator last modified the assay parameters.
Run Controls for Prints the setting used to specify which reagent cartridge to
Reagents By run for quality control. The following settings may be printed:
• Lot: Runs the controls only on one cartridge for each lot
loaded on the reagent carousel.
• Cartridge: Runs the controls for all cartridges and for
each lot loaded on the reagent carousel.
Operator Prints the identification of the operator who installed the assay
or the operator who last modified the assay parameters.
Module ID Prints the numbers of the processing modules that are

Pretreatment Option Prints one of the following assay pretreatment protocol types:
• None
• Pretreatment 7
• Pretreatment 7-7
Calibration Parameters area
Calibration Method Prints one of the following calibration methods:

• Point-to-point
• Linear regression
• 4PLC X - 4PLC Y

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• Cutoff
• Reference
Use Cal Factor From Prints the assay to reference for calibration information used
in result calculation.
NOTE: This parameter is printed only when the Calibration
Method parameter is Reference.
Calibration Interval Prints the amount of time in hours that the calibration curve is
valid. A value from 0 through 9999 can be configured. If 0 is
configured, the calibration interval is not tracked.
Replicates Prints the number of calibrator replicates used in the

calculation of the calibration.
Adjustment Method Prints the type of adjustment used in an adjustment

calibration. The following settings may be printed:
• Ratio techniques (Ratio A, Ratio AB, Adjustment)
• Linear transformation
• Parameter adjustment
• Curve shape

Type parameter is Adjust.
Type Prints the type of calibration performed for the assay. The
following settings may be printed:
• Full
• Adjust
• Index
Reference Assay Prints the reference calibration assay number that is used to
generate results.
Method parameter is Reference.
In-Use Stability Prints the maximum time in hours that the calibrators can be
(Hours) used on the processing module without refrigerated storage. A
value of zero indicates that in-use stability is not tracked.
Cal Prints the calibrator name.

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Concentration Prints the concentrations of the six calibrators used as points

for a Full calibration type or prints the concentrations for the
master reference curve and concatenations of the two-point
calibrators for an Adjust calibration type. Calibrator
concentrations are not printed for an Index calibration type.
Dilution Parameters area
Manual Dilution Prints the availability of the manual dilution factor for the
assay.
Default Dilution Prints the dilution protocol that is used as the default for
assay processing.
Dilution Ranges Prints the dilution information for the available automated
dilutions:
Dilution Name Prints the dilution name. The dilution

name must be the same name used for
a host computer.
Low Prints the low concentration range

allowed for the dilution.
High Prints the high concentration range

allowed for the dilution.
Specifications
result flags.
Age Prints the age and unit for the

configured age range.


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Result Units area
Result Units Prints the configured result unit.
computers.
Retest Rules area

Original Dilution Prints the dilution for the original test. The original test must
be run at this dilution to be considered for retesting.

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Result Range Prints the result range.
Replicates Prints the number of replicates for the specific retest assay
and dilution.

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Assay Parameter Report (Calculated) element descriptions Appendix D
Assay Parameter Report (Calculated) element

descriptions
The Assay Parameter Report contains information about calculated assays. The report can be
printed and used as a record of calculated assays for the laboratory.
Report Header area
was printed.
Assay Type Prints Calculated as the assay protocol type.
affects result measurement or calculation, an asterisk is
displayed next to the assay number to indicate that the assay
was modified.
• Enabled
• Disabled
Assay Status Prints Primary as the assay status.

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Appendix D Assay Parameter Report (Calculated) element descriptions
Date/Time Prints the date and time that an operator created or installed
the assay or an operator last modified the assay parameters.
Operator Prints the identification of the operator who created or

installed the assay or the operator who last modified the
assay parameters.
Formula Prints the calculated formula.
Constituent Prints the constituent assay label that is displayed in the

calculated formula. The following labels may be printed:
• Assay 1
• Assay 2
• Assay 3
• Assay 4
Assay Prints the name of the selected assay that is assigned to the
constituent assay label.
Minimum Prints the minimum result range for the selected assay.
Maximum Prints the maximum result range for the selected assay.
Specifications
result flags.
Age Prints the age and unit for the

configured age range.



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Assay Parameter Report (Calculated) element descriptions Appendix D

Result Units area
Result Units Prints the constituent result unit.
computers.
Retest Rules area

Original Dilution This parameter is not used for calculated assays.
Result Range Prints the result range.

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Appendix D Assay Parameter Report (Calculated) element descriptions

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Calibration Details Report (Linear) element descriptions (c‑series) Appendix D
Calibration Details Report (Linear) element

descriptions (c‑series)
The Calibration Details Report contains assay calibration details of a linear calibration. The
report can be configured to print automatically.
Report Header area
was printed.
Assay Name Prints the name of the assay.
used to order and process the calibration.
Reagent Lot Prints the lot number of the reagent cartridge.
Assay Number Prints the number defined for the assay. The assay number
when the calibration was performed.
Reagent SN Prints the serial number of the reagent cartridge.
Assay Version Prints the version defined for the assay.
Lot Expiration Prints the lot expiration date of the reagent cartridge.

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Appendix D Calibration Details Report (Linear) element descriptions (c‑series)
Cal Status Prints the calibration status of the reagent lot.
Calibrator Lot Prints the lot number of the calibrator used to calibrate the
assay.
For c‑series assays that use a blank calibrator set, the lot
number of the calibrator used to calibrate the assay is printed
first, followed by the lot number of the blank calibrator used to
Cal Date/Time Prints the completion date and time of the calibration.
Cal Type Prints the calibration type for the assay.
Lot Expiration Prints the lot expiration date of the calibrators used to
For c‑series assays that use a blank calibrator set, the lot
expiration date of the calibrator used to calibrate the assay is
printed first, followed by the lot expiration date of the blank
calibrator used to calibrate the assay.
Archive Status Prints the archive status of the data.
Cal Method Prints the mathematical procedure used to analyze the data.
Calibrator SN Prints the serial number of the first bottle used in the
calibrator set.
For c‑series assays that use a blank calibrator set, the serial
number of the first bottle used in the calibrator set is printed
first, followed by the serial number of the blank calibrator.
Archive Date/Time Prints the date and time that the data was archived.
Full Calibration Prints the expiration date and time of the full calibration. This
Expiration Date/Time element is printed only for assays that have a defined
Adjust Calibration Prints the expiration date and time of the adjust calibration.
Expiration Date/Time This element is printed only for assays that have a defined
Transmission Status Prints the transmission status information, which is used to


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Calibration Details Report (Linear) element descriptions (c‑series) Appendix D
Transmission Date/ Prints the date and time that the archive record was
Time transmitted.
Message Prints the message code number and description only if the
calibration status is Failed.
Calibrator ID Prints the name of the calibrator level.
in the assay parameters. Values are printed with the
configured assay units.
Absorbance Prints the median absorbance value for the calibrator level.
Factor Prints the calibration factor for the calibrator level.
Rep 1 Absorbance Prints the absorbance value for replicate 1.

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Appendix D Calibration Details Report (Potentiometric) element descriptions (c‑series)
Calibration Details Report (Potentiometric)

The Calibration Details Report contains assay calibration details of a potentiometric calibration.
The report can be configured to print automatically.
Report Header area
was printed.

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Calibration Details Report (Potentiometric) element descriptions (c‑series) Appendix D
assay.
calibrator set.

Transmission Date/ Prints the date and time that the calibration was transmitted.
Time
in the assay parameters. Only the default units are printed.
Cal mV Prints the median millivolt value for each calibrator level.

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Appendix D Calibration Details Report (Potentiometric) element descriptions (c‑series)
Slope Prints the percent response of the integrated chip technology

(ICT) module for the low and high calibrators.
Rep 1 mV Prints the millivolt value for replicate 1.

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Calibration Details Report (Use Cal Factor Blank) element descriptions
(c‑series) Appendix D
Calibration Details Report (Use Cal Factor Blank)

The Calibration Details Report contains assay calibration details of a Use Cal Factor Blank
calibration. The report can be configured to print automatically.
Report Header area
was printed.
Reference Assay Prints the photometric reference calibration assay used to

generate results.

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Appendix D (c‑series)
assay.
calibrator set.
Adjust Calibration Prints the expiration date and time of the adjust calibration.
Expiration Date/Time This element is printed only for assays that have a defined

Time transmitted.

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(c‑series) Appendix D
configured units of the reference assay.
Absorbance Prints the median absorbance value for the calibrator level.
Factor Prints the calibration factor for the calibrator level.

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Appendix D Calibration Details Report (Adjust) element descriptions (i‑series)
Calibration Details Report (Adjust) element

The Calibration Details Report contains assay calibration details of an adjust calibration. The
report can be configured to print automatically.
Report Header area
was printed.

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Calibration Details Report (Adjust) element descriptions (i‑series) Appendix D
assay.
Cal Date/Time Prints the completion date and time of the calibration only for
assays that have a defined calibration interval.
calibrator set.
Calibration Expiration Prints the expiration date and time of the calibration. This
Date/Time element is printed only for assays that have a defined

Time transmitted.
Cal 1 Ratio Prints the ratios for the calibration adjustment 1.
Cal 2 Ratio Prints the ratios for the calibration adjustment 2.

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Appendix D Calibration Details Report (Adjust) element descriptions (i‑series)
Mean RLU Prints the mean relative light units (RLUs) of the calibrator
replicates.
Rep 1 RLU Prints the RLU value for replicate 1.
For i‑series assays that use the reference calibration method,
values are printed with the configured units of the reference
assay.
Fit Concentration Prints the fit curve concentration value for each calibrator
level defined in the assay parameters. Values are printed with
assay.
Ref Cal RLU Prints the reference (master calibrator) data read from the
reagent bar code label.
Fit RLU Prints the fit curve RLU data for each calibrator.

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Calibration Details Report (Full) element descriptions (i‑series) Appendix D
Calibration Details Report (Full) element

The Calibration Details Report contains assay calibration details of a full calibration. The report
Report Header area
was printed.

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Appendix D Calibration Details Report (Full) element descriptions (i‑series)
assay.
calibrator set.

Time transmitted.

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Calibration Details Report (Full) element descriptions (i‑series) Appendix D

assay.
Fit Concentration Prints the fit curve concentration value for each calibrator
level defined in the assay parameters. Values are printed with
assay.
Fit RLU Prints the fit curve relative light unit (RLU) data for each
calibrator.
Mean RLU Prints the mean RLUs of the calibrator replicates.

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Appendix D Calibration Details Report (Index) element descriptions (i‑series)
Calibration Details Report (Index) element

The Calibration Details Report contains assay calibration details of an index calibration, which
provides the calibration data needed to determine a cutoff value. The report can be configured
to print automatically.
Report Header area
was printed.

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Calibration Details Report (Index) element descriptions (i‑series) Appendix D
assay.
Cal Date/Time Prints the completion date and time of the calibration only for
assays that have a defined calibration interval.
calibrator set.

Time transmitted.
Cutoff Prints the calculated cutoff value used for assay data
reduction.

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Appendix D Calibration Details Report (Index) element descriptions (i‑series)
%CV Prints the calculated percent coefficient of variation for the

calibrator.
Mean RLU Prints the mean relative light units (RLUs) of the calibrator
replicates.

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Calibration Summary Report element descriptions Appendix D
Calibration Summary Report element descriptions

The Calibration Summary Report contains assay calibration information about reagents that are
currently loaded on the system based on the last reagent scan. The report can be configured to
print automatically.
Report Header area
was printed.
Elements
Assay Prints the name of the assay.
Cal Date/Time Prints the date and time that the reagent lot was calibrated.
Status Prints the calibration status of the reagent lot.
Exp Date/Time Prints the date and time that the calibration expires for the
reagent lot.

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Appendix D Diagnostic History Report, Maintenance History Report element descriptions
Diagnostic History Report, Maintenance History

Report element descriptions
The Diagnostic History Report or the Maintenance History Report contains a summary table of
the maintenance procedures or diagnostics procedures that were performed during a specific
month. The Maintenance History Report also includes maintenance procedures that needed to
be performed during the specific month.
For each procedure listed in the summary table, additional details are included after the table.
Each report can be printed and used as a record of the maintenance procedures or diagnostic
procedures that were performed on the system.
Report Header area
was printed.
Elements
Status Prints one of the following approval statuses for the

Maintenance History Report:
• Approved
• Unapproved
This element is not printed on the Diagnostic History Report.
Approved Date/Time Prints the date and time that the log was approved. This
element is blank if the log has not been approved. This
element is not printed on the Diagnostic History Report.
Operator ID Prints the identification of the operator who approved the log.
This element is blank if the log has not been approved. This
element is not printed on the Diagnostic History Report.

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Diagnostic History Report, Maintenance History Report element descriptions Appendix D
used to perform the procedure.
Activity Month Prints the month and year of the log printed.
Summary Table area
Diagnostic Procedure, Prints the names of the procedures that have been performed
Maintenance for the specified month. The Maintenance History Report also
Procedure includes maintenance procedures that are scheduled or past
due for the month printed. Procedure names are grouped by
procedure category.
Numbers 1 through 31 Prints the status of each procedure performed for the month
printed. Numbers represent the days of the month. Bold
numbers represent Sundays. The following list explains the
descriptive elements of the summary table:
• A check mark indicates that the procedure has been
performed and has a status of Completed.
• An X indicates that the procedure has a status of
Scheduled, Pending, Canceled, Not Performed, or Failed.
If the procedure is performed multiple times on the same
day, the status of the last performed procedure is printed.
• An asterisk within the box indicates that a comment has
been entered for the procedure.
Procedure Details area
Procedure Name Prints the number and name of the procedure.
Procedure Category Prints the category of the procedure.
Date/Time Prints the date and time that the procedure was completed.
For maintenance logs, this element is blank if the procedure
has a status of Scheduled, Pending, or Not Performed.
Completion Status Prints the final status of the completed procedure. For
maintenance logs, this element is blank if the procedure has a
status of Scheduled, Pending, or Not Performed.
when the procedure was performed. For the Maintenance

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Appendix D Diagnostic History Report, Maintenance History Report element descriptions
History Report, this element is blank if the procedure has a

status of Scheduled, Pending, or Not Performed.
Comment Prints comments entered for the procedure.

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Exception List Report element descriptions Appendix D
Exception List Report element descriptions

The Exception List Report contains the number of exceptions on the Exception tab that have not
been rerun or released. The report can be printed and used as a record of exceptions for the
laboratory.
Report Header area
was printed.
Results area
Module Prints the module number of the module used to generate the
test exception.

printed as LAS/1.
SID Prints the sample identification.
Sample Type Prints one of the following sample types:

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Appendix D Exception List Report element descriptions
• Specimen
• Control
• Calibrator
Date/Time Prints the date and time that the samples were processed.
Message Prints the message code number and description.

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Log Report element descriptions Appendix D
Log Report element descriptions

Log reports contain the message codes generated by the instrument. The following unique log
reports can be generated and printed from the appropriate tab on the System Logs screen:
• System Log Report from the All Messages tab
• Notifications Log Report from the Notifications/Alerts tab
• Information Log Report from the Informational tab
• Inventory Log Report from the Inventory tab
• User Access Log Report from the User Access tab
• Configuration Log Report from the Configuration tab
• Interfaces Log Report from the Interfaces tab
• Abbott Mail Log Report from the Abbott Mail tab
Report Header area
was printed.
Elements
Date/Time Prints the date and time that the message code was
generated.
Module Prints the module number of the module that generated the
with the system control module is 6. This element is not
printed on the User Access Log Report, the Interfaces Log
Report, and the Abbott Mail Log Report.
Message Prints the message code number and description.

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Appendix D Log Report element descriptions
Message Type Prints the type of message code generated. This element is
not printed on the Information Log Report. Log reports have
four message types:
• Alert
• Critical
• Informational
• Notification
Category Prints the related message category. This element is not

printed on the Inventory Log Report, the User Access Log
Report, the Configuration Log Report, and the Abbott Mail Log
Report. Log reports have seven message categories:
• Abbott Mail
• Alinity PRO
• Configuration
• Host
• Inventory
• LAS
• User Access
Supply Name Prints the name of the supply item associated with the
message code. This element is printed only on the Inventory
Log Report.
when the message code was generated. This element is
printed only on the Inventory Log Report, the Configuration
Log Report, and the Abbott Mail Log Report.
Mail Category Prints the type of Abbott Mail item associated with the
message code. The Abbott Mail Log Report has four mail
categories:
• Assay File
• Assay Insert
• Calibrator Data
• System Update

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Log Report element descriptions Appendix D

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Appendix D Order List Report element descriptions
Order List Report element descriptions

The Order List Report contains information, including the minimum sample volume, about
pending specimens, controls, and calibrators. The report can be printed and used as an aid to
load samples.
Report Header area
was printed.
Elements

printed as LAS/1.
SID Prints the sample identification of the order, which can be one
of the following items:
specimen.

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Order List Report element descriptions Appendix D


• Specimen
• Control
• Calibrator
Code Prints the processing codes to indicate the processing

conditions.
Min Sample Volume Prints the minimum sample volume that is required in the
sample cup for the tests to be processed.

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Appendix D Procedure Report element descriptions
Procedure Report element descriptions

The Procedure Report contains information about a maintenance or diagnostic procedure that is
performed on the system. The report can be configured to print automatically when a
maintenance procedure is completed.
Report Header area
was printed.
Elements
Procedure Name Prints the number and name of the procedure.
Module Prints the module number of the module used to perform the
procedure.
Version Prints the version number of the procedure.

Date Prints the date that the procedure was completed.
Time Prints the time that the procedure was completed.
Category Prints the category of the procedure.
when the procedure was performed.
Status Prints one of the following statuses for the completed

procedure:
• Completed
• Failed
• User Canceled

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Procedure Report element descriptions Appendix D
Results Prints the results of the procedure.
Configure report settings, page 213

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Appendix D QC Analysis Report element descriptions
QC Analysis Report element descriptions

The QC Analysis Report contains detailed statistical data for assay control levels, including
module data for a date range, module cumulative data, and system cumulative data for a
multimodule system that has more than one processing module of the same type. The report can
be printed and used as a record of assay control levels for the laboratory.
Report Header area
was printed.
Control Name Prints the name of the control.
Control Lot Prints the lot number of the control.
Control Level Prints the level of the control that was processed.
Date Range Prints the control summary information for the selected date
range.
Control Expiration Prints the expiration date of the control lot and level.

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QC Analysis Report element descriptions Appendix D
Data area
Expected Prints the expected mean and standard deviation (SD) that
were configured for the control lot and level.
Manufacturer Prints the manufacturer's mean and SD that were configured

for the control lot and level.
Module Data for Date Prints the module cumulative data that was calculated for a
Range specific processing module and date range. Excluded results
are not included. The data includes the following information:
• Mean
• SD
• % CV (percent coefficient of variation)
• N (number of samples included)
• Range (calculated control range)
System Data for Date Prints the system cumulative data that was calculated for all
Range processing modules of the same type in the system and for a
specific date range. Excluded results are not included. The
data includes the following information:
• Mean
• SD
• % CV
• N
• Range
Module Cumulative Prints the module cumulative data that was calculated for a
specific processing module. Excluded results are not
included. The data includes the following information:
• Mean
• SD
• % CV
• N
• Range
System Cumulative Prints the system cumulative data that was calculated for all
processing modules of the same type in the system. Excluded

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Appendix D QC Analysis Report element descriptions
results are not included. The data includes the following

information:
• Mean
• SD
• % CV
• N
• Range
Results area
Prints the control information for the specified processing module and date range.
Date/Time Prints the date and time of each control result.
Result Prints the value and unit of the test result. Results that have
an asterisk are excluded from the calculations.
Reagent Lot Prints the master lot number of the reagent.
when the control was processed.
Released By Prints the identification of the operator logged onto the system
when the control result was released.
Flags Prints the flags associated with the control result.
Codes Prints the processing codes associated with the control result.
Excluded Prints an asterisk in the column if the control result was

excluded from the cumulative data.

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QC Levey-Jennings Report element descriptions Appendix D
QC Levey-Jennings Report element descriptions

The QC Levey-Jennings Report contains information about quality control graphs for the selected
assay. The report can be printed and used as a quality control record for the laboratory.
Report Header area
was printed.

Control Level Prints the level of the control that was processed.
Date Range Prints the date range of the control summary information.
Control Expiration Prints the expiration date of the control lot.
Comparison Type Prints one of the following comparison types, which is the
source of the mean and standard deviation (SD) used to
compare to the expected mean and SD:
• None
• Manufacturer
• Module Cumulative

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Appendix D QC Levey-Jennings Report element descriptions
• System Cumulative
Expected Prints the expected mean and SD that were configured for the
control lot and level.
Manufacturer Prints the manufacturer's mean and SD that were configured

for the control lot and level.
Module Data for Date Prints the module cumulative data that was calculated for a
Range specific processing module and date range. Excluded results
are not included. The data includes the following information:
• Mean
• SD
• % CV (percent coefficient of variation)
• N (number of samples included)
• Range (calculated control range)
System Data for Date Prints the system cumulative data that was calculated for all
Range processing modules of the same type in the system and for a
specific date range. Excluded results are not included. The
data includes the following information:
• Mean
• SD
• % CV
• N
• Range
If a system has only one processing module, the system

cumulative data is the same as the module cumulative data
that was calculated for the specific date range.
Module Cumulative Prints the module cumulative data that was calculated for a
specific processing module. Excluded results are not
included. The data includes the following information:
• Mean
• SD
• % CV
• N
• Range

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QC Levey-Jennings Report element descriptions Appendix D
System Cumulative Prints the system cumulative data that was calculated for all
processing modules of the same type in the system. Excluded
results are not included. The data includes the following
information:
• Mean
• SD
• % CV
• N
• Range
If a system has only one processing module, the system

cumulative data is the same as the module cumulative data
that was calculated.
Results area
Date/Time Prints the date and time of each control result.
Result Prints the value and unit of the test result. Results that have
an asterisk are excluded from the calculations.
Flags Prints the flags associated with the control result.
-2SD, -1SD, Mean, Prints a graphical view of where the point is located within the
+1SD, +2SD configured range. The point is represented by a plus sign.

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Appendix D QC Summary Report element descriptions
QC Summary Report element descriptions

The QC Summary report contains statistical data for assay control levels. The report can be
printed and used as a record of assay control levels for the laboratory.
Report Header area
was printed.
Elements
Date Range Prints the control summary information for the selected date
range.
Level Prints the level of the control that was processed.
N Prints the number of control points that are available for the
same control level, control lot, assay, and processing module
used in the calculation.
Flagged Prints the number of flagged control results.
Actual Mean Prints the mean that was calculated for the control level,
control lot, and assay for a processing module and the
specified date range.

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QC Summary Report element descriptions Appendix D
Actual SD Prints the standard deviation (SD) that was calculated for the
control level, control lot, and assay for a processing module
and the specified date range.
Actual %CV Prints the percent coefficient of variation that was calculated
for the control level, control lot, and assay for a processing
module and the specified date range.
Expected Mean Prints the expected mean that was configured for the control
level.
Expected SD Prints the expected SD that was configured for the control
level.
Expected Range Prints the expected control range that was configured for the
control level.

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Appendix D Reagent Status Report element descriptions
Reagent Status Report element descriptions

The Reagent Status report contains information about reagents that are currently loaded on the
system. The report can be printed and used as an aid to identify low or empty reagent kits
quickly.
Report Header area
was printed.
Elements
M/P Prints the module (M) number and position (P) number in the
reagent carousel where the reagent carousel inventory item is
loaded.
RSM/P Prints the reagent and sample manager (RSM) module

number and position (P) number on the loading area where
the reagent carousel inventory item is loaded or unloaded.
Name Prints the name of the reagent carousel inventory item.
Cartridge Status Prints the status of the reagent carousel inventory item.
Remaining Tests Prints the estimated amount that remains in the reagent
carousel inventory item. Information is not printed for vial
racks.
Cal Status Prints the calibration status of the assay that uses the reagent
cartridge. Information is printed only for reagent cartridges.
Lot Prints the lot number of the reagent carousel inventory item.
Information is not printed for vial racks.

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Reagent Status Report element descriptions Appendix D
SN Prints the serial number of the reagent carousel inventory

item. Information is not printed for vial racks.
Expiration Prints the expiration date of the reagent carousel inventory

Overridden is printed. Information is not printed for vial racks.
Load Status Prints the load or unload status of the reagent carousel
inventory item.
Onboard Stability Prints the number of onboard stability days that remain for
is printed. Information is not printed for vial racks.
Descriptions of load statuses, page 619

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Appendix D Rerun List Report element descriptions
Rerun List Report element descriptions

The Rerun List Report contains information about rerun orders for pending specimens and
controls. The report can be printed and used as an aid to locate samples that were ordered for
reruns.
Report Header area
was printed.
Elements
Module Prints the module number when the number is specified in the
Rerun Options flyout.

printed as LAS/1.
SID Prints the sample identification of the order, which can be one
of the following items:
specimen.

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Rerun List Report element descriptions Appendix D


• Specimen
• Control
Assay Prints the name of the assay ordered.
Status Prints the current test status (Pending, Scheduled, Running, In

Process, or Complete) of the assay ordered.
Code Prints the processing codes to indicate the processing

conditions.

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Appendix D Result Details Report element descriptions
Result Details Report element descriptions

The Result Details Report contains the result details for specimens and controls. The report can
be printed and used as a record of result details for the laboratory.
Report Header area
was printed.
Elements
Patient Name Prints the name of the patient. This element is printed only for
specimens.
Control Name Prints the name of the control and the control level. This
element is printed only for controls.
Patient ID Prints the patient identification. This element is printed only

for specimens.
Control Level Prints the name of the control level. This element is printed
only for controls.
when the test was processed.
Gender Prints the gender of the patient. This element is printed only
for specimens.
Control Lot Prints the lot number of the control. This element is printed
only for controls.

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Result Details Report element descriptions Appendix D
Completion Date/Time Prints the date and time that the tests in process were
completed.
Date of Birth Prints the date of birth for the patient. This element is printed
only for specimens.
Control Lot Exp. Prints the expiration date of the control lot. This element is
printed only for controls.
Transmission Status Prints the status of the test transmission to the host.
Released By Prints the identification of the operator logged onto the system
when the test was released.
Assay Name Prints the name of the assay file.
Reference Assay Prints the reference calibration assay used to generate

results. This element is printed only when the Calibration
Method parameter is Reference or Use Cal Factor Blank.
Doctor Prints the name of the patient's doctor. This element is printed
only for specimens.
Calibrator Lot Prints the lot number of the calibrator used to generate the
calibration curve to produce the results. Functionality is
currently not available.
Location Prints the location associated with the patient. This element is
printed only for specimens.
Calibration Date/Time Prints the date and time of the reagent calibration.
Archive Status Prints one of the following archive statuses for the test:
• Archived

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Appendix D Result Details Report element descriptions
• Not Archived
Draw Date/Time Prints the date and time that the sample was drawn. This
element is printed only for specimens.
Archive Date/Time Prints the date and time that the test was archived.
Comment Prints the comment entered for the test.
Data Table area

printed as LAS/1.
Result Prints the value and unit of the result.
Range Prints one of the following range types:

• For specimens, the normal or therapeutic range that was
configured for the assay.
• For controls, the control range that was configured for
the assay.
Dilution Prints the type of dilution used to process the test.
RLU (i‑series) Prints the response value in relative light units that is used to
calculate the result.
Absorbance (c‑series) Prints the response value in absorbance that is used to

calculate photometric result.
mV (c‑series) Prints the response value in millivolts that is used to calculate

ICT result.
Cuvette (c‑series) Prints the number of the cuvette used to process the test.

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Result Details Report element descriptions Appendix D
Constituent Information area

This area is printed only for calculated assay results.
Module Prints the module number and serial number of the module
used to process the constituent test.
Assay Prints the constituent assay name.
Reagent Lot Prints the master lot number of the constituent reagent.
Reagent SN Prints the serial number of the constituent reagent cartridge.
Result Prints the value and unit of the constituent result.
Flags Prints the flags associated with the constituent results.

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Appendix D Result List Report element descriptions
Result List Report element descriptions

The Result List Report contains the results for specimens and controls. The report can be
printed and used as a specimen and control record for the laboratory.
Report Header area
was printed.
Elements
Module Prints the module number of the module used to process the
test.

printed as LAS/1.
SID Prints the sample identification.
• The patient's name for specimen orders.
Assay Prints the name of the test.
Result Prints the value and unit of the test result.
Interpretation Prints the interpretation of the result value obtained. This

element is printed only for specimens.

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Result List Report element descriptions Appendix D
Time Prints the date and time that the tests in process were
completed.

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Appendix D Sample Laboratory Report element descriptions
Sample Laboratory Report element descriptions

The Sample Laboratory Report contains the specimen results for a specific sample. The report
can be printed and used as a sample record for the laboratory.
Report Header area
was printed.
Elements
Name Prints the name of the patient.
Gender Prints the gender of the patient.

printed as LAS/1.
Patient ID Prints the patient identification.
Draw Date/Time Prints the date and time that the sample was drawn.
Date of Birth Prints the date of birth for the patient.
Doctor Prints the name of the patient's doctor.
Location Prints the location associated with the patient.

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Sample Laboratory Report element descriptions Appendix D
Data Table area
Assay Prints the name of the assay file.
Result In Range Prints the result and result unit when the result falls within the
normal or therapeutic range for the assay.
Result Out of Range Prints the result and result unit when the result falls outside
the normal or therapeutic range for the assay.
Range Prints the normal or therapeutic range for the assay.

Comment Prints the comment entered for the test.

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Appendix D System Update Details Report element descriptions
System Update Details Report element

descriptions
The System Update Report contains a detailed log of a system update. The report can be
printed and used as a record of the system update for the laboratory.
Report Header area
was printed.
Details area
TSB Number Prints the technical service bulletin (TSB) number. System
Product Code Prints a list of product codes that apply to the TSB that is
printed. The following product codes are available:
• 205 (Alinity i)
• 210 (Alinity c)
• 214 (system control module)
Module SN Prints the serial number of the module associated with the
TSB.
Access Level Prints the minimum access level that is necessary to install
the TSB. The System Updates screen has five access levels:
• General
• Supervisor
• Administrator

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System Update Details Report element descriptions Appendix D
• CSC
NOTE: This access level requires Abbott Customer
Service authorization.
• FSE
NOTE: This access level requires field service
installation.
Mandatory Prints if the system update is mandatory and must be

installed.
Requires Verification Prints if the TSB requires a manual verification after the
installation is completed. If the TSB requires a manual
verification, the System Update Letter for the TSB provides
instructions and can be printed.
Requires System Prints if the software needs to be restarted after the TSB is
Restart installed.
Prerequisite Update Prints a list of TSB numbers that must be installed before the
TSB that is printed is installed.
Superseded Updates Prints a list of TSB numbers that are outdated by the
installation of the TSB that is printed.
Description Prints a short description of the TSB. For more information,
the System Update Letter can be printed.
Comments Prints the comment for the system update.
Activity Log area
Date/Time Prints the date and time of the current status for the TSB.
Status Prints the status of each system update. The System Updates
• Available
• Download Failed
• Install Failed

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Appendix D System Update Details Report element descriptions
• Applied
• Superseded
• Ignored
when the status was updated for the TSB.

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System Update List Report element descriptions Appendix D
System Update List Report element descriptions

The System Update List Report contains system updates that are available for installation,
system updates that are installed, and system updates that have been declined by the operator.
The report can be printed and used as a record of system updates for the laboratory.
Report Header area
was printed.
Elements
TSB Number Prints the technical service bulletin (TSB) number. System
Module SN Prints the serial number of the module associated with the
TSB.
Status Prints the status of each system update. The System Updates
• Available
• Download Failed
• Install Failed
• Applied

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Appendix D System Update List Report element descriptions
• Superseded
• Ignored
Date/Time Prints the date and time of the current status for the TSB.

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User-Defined Maintenance Details Report element descriptions Appendix D
User-Defined Maintenance Details Report element

descriptions
The User-Defined Maintenance Report contains a detailed description, including the procedure
instructions, of a user-defined maintenance procedure. The report can be printed and used as a
record of the user-defined maintenance procedure that was performed on the system.
Report Header area
was printed.
Elements
Procedure Number Prints the number and name of the procedure.

and Name
Version Prints the version of the procedure. When a new procedure is
created, the version is defined as 1. After the procedure is
edited and saved, the version number increases incrementally.
Frequency Prints the frequency of the procedure:

• Daily
• Weekly
• Monthly
• Quarterly
• Triannual
• Semiyearly
• Yearly
• As Needed

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Appendix D User-Defined Maintenance Details Report element descriptions
when the procedure was created or edited.
Last Edited Prints the date and time that the procedure was created or
edited.
Module Prints the required module type for the procedure. The
following module types may be printed:
• RSM
• i‑series
• c‑series
Procedure Description Prints a brief procedure description.

Procedure Prints the procedure instructions.
Instructions

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User-Defined Maintenance Details Report element descriptions Appendix D
NOTES

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Glossary
Glossary
1-point adjustment (c‑series photometric) A calibration type that uses the absorbance data of one
calibrator to adjust the calibration curve.
2-point adjustment (c‑series photometric) A calibration type that uses the absorbance data of the reagent
blank and one calibrator to adjust the calibration curve.
4PLC methods (i‑series) Full calibration methods for four-parameter logistic curve fit or four-
parameter logistic calibration (4PLC) that use the difference between predicted and
observed calibrator concentrations or signals to generate a calibration curve. The
system software uses the 4PLC with x residual minimization (x-weighted) method and
the 4PLC with y residual minimization (y-weighted) method.
AbbottLink A data-sharing software between laboratory instrumentation and Abbott internal

systems that collects and transmits instrument data.
Abbott Mail A data-sharing mechanism that is used to receive information to download from
AbbottLink.
absorbance limit (c‑series) A configured range of absorbance values that are considered as acceptable
for measurement purposes. Absorbance values that fall outside the range are not
used to calculate results.
absorbance method (c‑series photometric) A full calibration method that uses the comparison between the
absorbance of the sample and the absorbance of water to calculate results. For end-
point assays, the data is expressed as absorbance. For rate assays, the data is
expressed as the rate of absorbance change per minute.
accessories Service accessories are items that are used for system installation and for
maintenance and troubleshooting procedures. Some spare parts are used as needed
for component replacement.
Acid Wash (c‑series) An acidic wash solution that is used by the cuvette washer to clean the
cuvettes after sample analysis. A dilution of the Acid Wash solution is used to wash
the probes.
active screen The screen that is displayed on the user interface.
active window The window that is displayed on the user interface.
adjustment (c‑series photometric) The method that uses one of the following measurements to
calibration adjust a calibration curve:
• A new measurement of a reagent blank
• A new measurement of one specific point of a full calibration curve
• A new measurement of a reagent blank and one specific point of a full calibration
curve

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Glossary
The system software uses the new measurements to adjust the existing calibration
data points and then generates a new calibration curve. See also blank adjustment,
page 1703, 1-point adjustment, page 1701, and 2-point adjustment, page 1701.
adjustment (i‑series) The measurement of two points of a master reference curve specified for an
calibration assay. The system software uses master calibration data to generate a calibration
curve that is specific to a processing module when quantitative assays are used. See
also ratio technique method, page 1711, linear transformation method, page 1708,
parameter method, page 1709, and curve shape method, page 1705.
Alinity ci‑series A multimodule system that includes a clinical chemistry module and an immunoassay
module, each performing all sample-processing activities, and a system control
module to provide a single user-friendly interface.
Alinity c processing A chemistry analyzer that performs sample processing. The Alinity c processing
module module allows random and continuous access as well as priority and automated retest
processing by using photometric and potentiometric detection technologies. The
Alinity c processing module uses photometric detection technology to measure sample
absorbance for the quantification of analyte concentration, uses potentiometric
detection technology to measure the electrical potential in a sample, and uses an
integrated chip technology (ICT) module to measure potentiometric assays
(electrolytes).
Alinity i processing A fully automated immunoassay analyzer that performs sample processing. The
module Alinity i processing module allows random and continuous access as well as priority
and automated retest processing by using chemiluminescent microparticle
immunoassay (CMIA) detection technology. CMIA detection technology is used to
determine the presence of antigens, antibodies, and analytes in samples.
Alinity PRO A data-sharing software application between Alinity systems and the Alinity PRO
computer. Alinity PRO allows the laboratory to share its inventory of reagents,
calibrators, and controls between different instruments that are controlled by a
different user interface computer. In addition, Alinity PRO provides an operational
dashboard that allows the operator to view a live representation of the current status
of all Alinity systems from one computer.
aliquot tube A tube (75 mm to 100 mm in height) that contains an aliquot of sample. Aliquot tubes
may be used with sample cups. If only a tube is used, the sample gauge can be used
to verify that the sample volume in the tube is adequate.
Alkaline Wash (c‑series) An alkaline wash solution that is used by the cuvette washer to clean the
cuvettes after sample analysis.
alphanumeric Characters that are defined by Abbott Laboratories as A through Z, a through z, 0

characters through 9, and special characters , / > < ? ; : ] [ \ } { ' - = ~ ! @ # $ % ^ & * ) ( _ +
and <space>.
American Society for An organization that defines the specifications for the transfer of information between
Testing and Materials laboratory instruments and computer systems.
assay An analysis to determine the presence, absence, or quantity of one or more analytes.

80000071-105 - 2018-09-10
Glossary
assay calibration The method by which the known concentrations of samples are analyzed, the
instrument response values are recorded, and the measured values are plotted
against the known concentration to create a curve.
assay file A file that contains assay-specific parameters.
assay parameters Values that define specific characteristics of an assay or verify the performance of an
assay.
assay settings Settings within each assay configuration category that the system administrator
configures to meet site-specific requirements.
assay-specific Assay-specific information that is included with each reagent kit.

reagent package
insert
ASTM See American Society for Testing and Materials, page 1702.
automated retest The process that the system uses to generate rerun orders for specimens
automatically.
bar code label A unique identifier that contains black bars that represent the sample information.
bar code scanner A hardware component on the system control module that is used to scan sample bar
codes and supply bar codes.
batch processing A type of sample processing where each sample has the same assay or assays that
were ordered. Batch processing begins on the sample labeled with the starting SID
and continues until the sample labeled with the ending SID is processed. All samples
between the starting SID and the ending SID, regardless of the sequence or SID, are
included in the batch process.
biological hazard An activity or an area where the operator may be exposed to potentially infectious
material.
blank adjustment (c‑series photometric) A calibration type that uses the absorbance data of the reagent
blank to adjust the calibration curve.
bulk solution (Alinity c) An area in the supply and pump center that provides the onboard storage
reservoir area for bulk solutions (ICT Reference Solution, Alkaline Wash, and Acid Wash) in use
during assay processing.
bulk solution (Alinity i) An area in the supply center that provides the onboard storage for bulk
reservoir area solutions (Concentrated Wash Buffer, Trigger Solution, and Pre-Trigger Solution) in
use during assay processing.
bulk solutions Liquid solutions that are provided in large quantities for use during assay processing.
bulk solution storage (Alinity c) An area in the supply and pump center that provides the onboard storage
area for replacement bulk solution bottles of ICT Reference Solution, Alkaline Wash, and
Acid Wash.

80000071-105 - 2018-09-10
Glossary
bulk solution storage (Alinity i) An area in the supply center that provides the onboard storage for
area replacement bulk solution bottles of Concentrated Wash Buffer, Trigger Solution, and
Pre-Trigger Solution.
calibration The method used to determine the reportable range of an assay.

verification
calibrator Material that has a known concentration of a specific analyte. Calibrators are used to
create the calibration against which samples are measured. See also single-
constituent calibrator, page 1712.
chemiluminescence (i‑series) The emission of light produced by a chemical reaction.
chemiluminescent (i‑series) A detection technology used to measure analyte concentration.

microparticle
immunoassay
Clinical and A nonprofit organization that provides a communication forum for the development,
Laboratory Standards promotion, and use of standards for the worldwide medical science community.
Institute
CLSI See Clinical and Laboratory Standards Institute, page 1704.
CMIA (i‑series) See chemiluminescent microparticle immunoassay, page 1704.
color correction (c‑series photometric) An adjustment performed on the upper and lower limits of the
absorbance range to correct for the presence of color in the sample. Any flags or
message codes generated use the adjusted absorbance range and reflect the analyte
concentration instead of the sample color. Color correction does not adjust the
reported result.
Concentrated Wash (i‑series) A solution that contains phosphate-buffered saline and antimicrobial agents.
Buffer The solution is diluted tenfold by the system and then is pumped to sample and
reagent pipettor assemblies and to wash zones during assay processing. See also
wash buffer, page 1714.
Concentrated Wash (i‑series) An assembly with a magnetic float sensor that indicates when the liquid level
Buffer level sensor in the Concentrated Wash Buffer reservoir is low.
configuration The process that is used to define the system, assay, quality control, and calibration
settings to meet the site-specific requirements.
consumables Replenishable items that are needed for sample processing on the Alinity ci‑series.
Examples of consumables include bulk and onboard solutions, calibrators, controls,
reagents, and sample cups.
context-sensitive help Information that is displayed online and is specific for the active screen, flyout, or
message code.
control Material that has a known concentration of a specific analyte. Controls are run with
patient samples and are used to monitor the assay and system performance over time.
See also single-constituent control, page 1712 and multiconstituent control, page
1709.

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Glossary
c‑series The name used to refer to all Alinity chemistry processing modules in general.
curve shape method (i‑series) An adjustment method that uses the relative light unit values that are stored
in a reagent bar code for calibrators A through F to determine the four-parameter
logistic curve fit or four-parameter logistic calibration parameters of a master
calibration. Calibrator 1 and calibrator 2 adjusters are used to provide an instrument-
specific calibration curve that is based on the shape of the curve.
cutoff assay method (i‑series) An index calibration method that measures relative light unit values and
calculates a cutoff value.
cuvette (Alinity c) A rectangular glass container that holds the assay reaction components for
sample analysis.
cuvette dry tip (c‑series) Absorbent material on the end of a cuvette washer nozzle that is used to
dry a cuvette after it has been washed and before a sample is dispensed into it.
cuvette segment (Alinity c) A component of the reaction carousel that holds the cuvettes. Each cuvette
segment holds 11 cuvettes. The processing module contains 17 cuvette segments.
cuvette segment (c‑series) An accessory that is placed in the reaction carousel during the sample and
alignment tool reagent pipettor calibration procedures.
cuvette washer (c‑series) A device with eight nozzles that washes and dries the cuvettes before and
after each use.
cycle power The process of removing power from a system component and then reapplying power
to the component after a certain time period has elapsed.
decontamination The process that is used to remove contamination because of normal use from daily
system operations or because of spills.
depressed Concentration that is less than expected.

concentration
diagnostic procedure A procedure that can be used to confirm the status of assemblies and mechanisms to
help identify and resolve operational problems.
diluted wash buffer (i‑series) An assembly with a magnetic float sensor that indicates when the liquid level
level sensor in the diluted wash buffer reservoir is low.
diluted wash buffer (Alinity i) An onboard container in the supply center that holds 4 L of diluted wash
reservoir buffer.
elevated Concentration that is greater than expected.

concentration
end-point assay (c‑series) Reactions that are allowed to proceed until all reactant is depleted and the
absorbance is stable. When the reaction is completed, the system measures the
absorbance readings used for calibration and to calculate results.
end ratio (c‑series) An assay validity reaction check that uses a ratio of absorbances (A ÷ B)
measured at two different times during the reaction to verify whether prozone or other
reaction anomalies have occurred.

80000071-105 - 2018-09-10
Glossary
end subtraction (c‑series) An assay validity reaction check that uses the difference between
absorbances (A - B) measured at two different times during the reaction to verify
whether prozone or other reaction anomalies have occurred.
erratic results Results that exceed the expected tolerance limits for an assay.
exception A test in progress or a scheduled order that fails to be completed.
factor method (c‑series photometric) A full calibration method that uses a reagent blank and a fixed
calibration factor value to calculate results.
FlexRate method (Alinity c) A method used to determine the concentration of samples for an enzymatic
assay that exceeds the linear range. Data points in the flex read time are used for
high-activity and high-concentration samples. Results calculated by using these data
points are identified by the FLEX result flag.
flush A procedure that is performed to flush solution through the fluidics system to remove
bubbles.
full calibration (c‑series) The measurement of a reagent blank and all specified data points. The
absorbance value for each point is plotted against the known concentration and the
system software generates a new calibration curve. Unknown samples are then
evaluated against the calibration curve. See also absorbance method, page 1701,
factor method, page 1706, linear method, page 1707, logit-4 method, page 1708,
spline method, page 1712, and use cal factor blank method, page 1714.
full calibration (i‑series) The measurement of six points specified for a quantitative assay plotted
against known concentrations. The system software uses calibration data to generate
a calibration curve that is specific to a processing module. See also point-to-point
method, page 1710, linear regression method, page 1708, and 4PLC methods, page
1701.
general operator An access level (operator ID and optional personal identification number) for the
logon system control module that is used to display the current operator ID on various
screens and to print the operator ID of the current user on printouts and reports.
Health Level Seven An organization that develops standards for the exchange of information between
International medical applications.
HL7 See Health Level Seven International, page 1706.
host An auxiliary computer system or a laboratory information system (LIS) that can
communicate with the Alinity ci‑series.
host query time-out The length of time that the Alinity ci‑series waits for a response from the host.
ICT (c‑series) See integrated chip technology, page 1707.
ICT aspiration pump (c‑series) A syringe-drive pump that uses the syringe on the right side of the pump to
deliver samples or ICT Reference Solution into the ICT module for measurement. After
measurement is completed, the ICT aspiration pump uses the syringe on the left side
of the pump to aspirate waste from the ICT high-concentration waste area to the high-

80000071-105 - 2018-09-10
Glossary
ICT module (c‑series) An integrated chip that is a component of the ICT unit and contains the
sodium (Na+), potassium (K+), chloride (Cl-), and reference electrodes.
ICT Reference (c‑series) A midconcentration standard solution that is aspirated and analyzed by the
Solution ICT module before and after each sample. The solution provides a reference potential
that is used in result calculation.
ICT unit (c‑series) A device that has an ICT probe and an ICT module. The ICT unit is used to
perform the indirect potentiometric analysis of sodium (Na+), potassium (K+), and
chloride (Cl-). The ICT probe aspirates the sample. The ICT module simultaneously
measures Na+, K+, and Cl- by using integrated chip technology.
index calibration (i‑series) The method used for qualitative (cutoff) assays in which an index calibrator
is run to generate the cutoff value for the assay. See also cutoff assay method, page
1705.
induction heater (Alinity i) An optional hardware component in which the sample probe is heated and
wash cup the wash buffer is warmed as it flows through the probe to provide improved washing.
integrated chip (c‑series) The method used to simultaneously measure sodium, potassium, and
technology chloride. ICT methodology uses solid-state, ion-selective electrodes that are contained
in one chip (ICT module), which reduces the maintenance that is necessary to perform
electrolyte measurements.
i‑series The name used to refer to all Alinity immunoassay processing modules in general.
laboratory A track system that automates preanalytical processing, sample handling, and delivery
automation system of samples to analyzers for sample test processing, and that prepares samples for
refrigerated storage.
lamp (c‑series) An optical device that provides the light source for photometric assay
measurement. The processing module uses a tungsten-halogen lamp.
LAS See laboratory automation system, page 1707.
limit of blank The highest value that is likely to be observed in a series of results for a sample that
contains no analyte.
limit of detection The actual concentration at which an observed test result is likely to exceed the limit
of blank and therefore may be declared as detectable.
limit of quantitation The lowest actual concentration at which the analyte is reliably detected and at which
the uncertainty of the observed test result is less than or equal to the goal of
uncertainty.
linearity range (c‑series photometric) Minimum and maximum reportable values of an assay. For
c‑series photometric assays, the system adjusts these values by the sample dilution
factor.
linear method (c‑series photometric) A full calibration method that uses a reagent blank and one to
six calibrators to generate a point-to-point calibration curve.

80000071-105 - 2018-09-10
Glossary
linear regression (i‑series) A full calibration method that uses the linear relationship between the
method relative light unit value and the concentration of the analyte in the sample to generate
a calibration curve.
linear transformation (i‑series) An adjustment method that assumes a linear relationship between the
method calibrator relative light unit values that are generated by the system and the master
calibration information that is stored in a reagent bar code.
load diverter (i‑series) A mechanism that directs reaction vessels on the process path from the load
lane to the incubation lane during assay processing.
LoB See limit of blank, page 1707.
LoD See limit of detection, page 1707.
logit-4 method (c‑series photometric) A full calibration method that uses a reagent blank and one to
six calibrators to generate a point-to-point calibration curve. This method is applicable
to assays for which the absorbance or absorbance change increases as the calibrator
concentration increases.
logon An identifier that controls access to certain functionality on the system control module.
The system software has three types of logons:
• General operator
• Supervisor
• System administrator
Additionally, Abbott Customer Service may provide a user name and a temporary
password to operators who call for troubleshooting assistance. This logon authorizes
selected functions in addition to those functions allowed by the system administrator
logon.
LoQ See limit of quantitation, page 1707.
maintenance log An electronic log that is updated by the system to track the performance of
maintenance procedures.
maintenance A scheduled procedure or an as-needed cleaning procedure that is performed to

procedure ensure the appropriate functionality of the system.
maximum absorbance (c‑series photometric) An assay validity check that defines maximum acceptable
variation absorbance variation that is allowed for absorbance readings within the main read
time.
menu bar The area at the left side of the system software screens that provides navigation
elements that are used to display screens, flyouts, and menus.
message A user interface element that provides information about conditions or errors of
system operation.
message code A numeric identifier for a message.

80000071-105 - 2018-09-10
Glossary
multiconstituent A sample that contains multiple analytes. For each multiconstituent control, a
control maximum of six levels can be configured and analyzed.
network connector A device that provides a connection from the user interface computer, through the
firewall, to the wide area network (WAN) and to other external devices, such as the
host interface, a middleware computer, and Alinity PRO.
onboard solutions (c‑series) Detergents that are used to wash sample probes, reagent probes, mixers,
and reaction cuvettes.
onboard stability The amount of time that a reagent or solution remains stable after it is opened and
placed on the system in its designated location.
onboard vial rack An accessory that holds six vials of calibrators or controls. Onboard vial racks are
stored in the reagent carousel.
operator ID A string of alphanumeric characters that an operator enters when the operator logs on
to the system. An operator ID can contain a maximum of 12 alphanumeric characters.
The operator ID can be used with a password to provide access to system control
module functionality.
optimum sampling (c‑series) An automatic process in which the processing module rearranges the
sequence feature sampling sequence to maximize the processing speed and the system throughput. This
rearrangement prevents the consecutive aspiration of interfering reagents and
therefore reduces the number of required washes and unused cuvettes.
O-ring A flexible seal that is used in many fluidics connections to prevent leakage at the
connections.
OSS (c‑series) See optimum sampling sequence feature, page 1709.
overaspiration The additional volume of sample that is aspirated by the system to prevent the water
volume in the sample probe from diluting the sample.
parameter method (i‑series) An adjustment method that uses relative light unit values that are stored in a
reagent bar code for calibrators A through F to determine the four-parameter logistic
curve fit or four-parameter logistic calibration parameters of a master calibration.
Calibrator 1 and calibrator 2 adjusters are used to provide an instrument-specific
calibration curve that is based on the parameters.
password A string of alphanumeric characters that an operator enters when the operator logs on
to the system. A password is used with an operator ID to provide access to system
control module functionality. A password can be a personal identification number.
personal A string of numeric characters that an operator enters when the operator logs on to
identification number the system. A personal identification number is used with an operator ID to provide
access to system control module functionality.
photometer (c‑series) A device that uses a concave diffraction grating to measure the luminous
intensity, luminous flux, illumination, and brightness at 16 different wavelengths.
photometric reads (c‑series) A series of absorbance measurements that occur for each reaction cuvette
as it passes the photometric read position. These measurements are used to calculate
the result concentration.

80000071-105 - 2018-09-10
Glossary
photometric timing (c‑series) The progression of a reaction from the initial sample dispense to the final
read phase, which is represented as the elapsed time at each of the 38 photometric
points.
photomultiplier tube (i‑series) A detector in the chemiluminescent microparticle immunoassay (CMIA)

reader that receives and amplifies light signals from the reaction solution.
PIN See personal identification number, page 1709.
pipettor A device that detects, aspirates, transfers, and dispenses samples and reagents.
PMT (i‑series) See photomultiplier tube, page 1710.
point-to-point method (i‑series) A full calibration method that uses the average relative light unit value
obtained for each calibrator compared to the calibrator concentration to generate a
calibration curve.
Pre-Trigger Solution (i‑series) A solution that contains 1.32% (W/V) hydrogen peroxide solution that
separates the acridinium dye from the conjugate that is bound to the microparticle
complex. This action prepares the acridinium dye for the addition of Trigger Solution.
Pre-Trigger Solution (i‑series) An assembly with a magnetic float sensor that indicates when the liquid level
level sensor in the Pre-Trigger Solution reservoir is low.
primary tube A tube (75 mm to 100 mm in height) that contains a sample obtained by venipuncture.
Primary tubes may be used with sample cups. If only a tube is used, the sample
gauge can be used to verify that the sample volume in the tube is adequate.
processing module An analyzer that performs all sample-processing activities from sample aspiration to
final result reporting. The type and number of processing modules determine the
system configuration.
purified (instrument) Water that has a resistivity of 1 MΩ • cm or greater and a microbiological content of
water 1000 colony-forming units per milliliter or less.
rack An accessory that is used on the reagent and sample manager to transport
specimens, calibrators, and controls to the sample pipettor.
rack ID The identification number assigned to a rack. A rack ID has five alphanumeric
characters.
rate assay (c‑series) Reactions that are allowed to reach a stable rate in which the change in
absorbance between readings is constant. The system performs several readings
during this time, calculates the change of absorbance per minute (rate), and then
uses the rate to calculate results.
rate ratio (c‑series) An assay validity reaction check that uses a ratio of rates (A ÷ B) measured
at two different times during the reaction to verify whether prozone or other reaction
anomalies have occurred.
rate subtraction (c‑series) An assay validity reaction check that uses the difference between rates (A -
B) measured at two different times during the reaction to verify whether prozone or
other reaction anomalies have occurred.

80000071-105 - 2018-09-10
Glossary
ratio technique (i‑series) An adjustment method that compares the relative light unit value of
method calibrators to the corresponding calibrator values from a master calibration curve.
reaction carousel (c‑series) A device that rotates counterclockwise to position the cuvettes for sample
and reagent dispense, mixing, photometric or potentiometric analysis, and cuvette
washing.
reaction vessel (i‑series) A disposable container in which the chemiluminescent microparticle

immunoassay (CMIA) reaction occurs. Reaction vessels (RVs) are stored in bulk in the
RV hopper and are loaded automatically into the process path as needed. The
maximum onboard storage is 1000 RVs. RVs can be added to the RV hopper at any
time.
reagent and sample A transport system used to load calibrators, controls, specimens, reagents, and
manager onboard solutions. The design of the reagent and sample manager (RSM) provides
random and continuous access to load and unload sample racks, calibration and
control racks, and reagent cartridges. One primary RSM transports samples and
reagents through an Alinity ci‑series regardless of the type and number of processing
modules.
reagent carousel (Alinity c) A rotating, circular device in the reagent supply center that holds a
maximum of 70 bar-coded reagent cartridges, onboard solutions, sample diluents, and
vial racks in a cooled environment at a controlled temperature.
reagent carousel (Alinity i) A rotating, circular device in the reagent supply center that holds a maximum
of 47 bar-coded reagent cartridges, maintenance solutions, and vial racks in a cooled
environment at a controlled temperature.
reagent kit One or more cartridges that contain all the necessary reagent components for an
Alinity ci‑series assay. See also consumables, page 1704.
reference method (i‑series) The calibration method that uses a calibration curve generated for another
assay (reference assay) to calculate results. This method is used when two or more
assays use the same reagent.
relative light unit The sum of the chemiluminescent light signal produced during the final reaction.
released result A control or patient result that was determined to be acceptable. Released results can
be viewed on the Control tab and Specimen tab of the Results screen. If the system
interfaces with a host computer, the released results are transmitted to the host.
RLU See relative light unit, page 1711.
RSM See reagent and sample manager, page 1711.
RSM bar code reader An imaging camera on the reagent and sample manager that reads bar code labels on
samples, racks, and cartridges.
RV (i‑series) See reaction vessel, page 1711.
RV access door (Alinity i) An opening used only for diagnostic purposes that provides access to one
position on the reaction lane on the process path. The RV access door must be
closed during system operation.

80000071-105 - 2018-09-10
Glossary
RV waste chute (Alinity i) A device in the supply center that receives used reaction vessels (RVs) by
gravity and directs them into the RV waste container. The RV waste container can be
removed during assay processing. When the container is removed, the RV waste chute
closes and holds 50 RVs before the processing module pauses.
RV waste container (Alinity i) A container in the supply center that holds the used reaction vessels.
RV waste storage tray (Alinity i) A tray in the supply center that holds the RV waste container.
sample cup A 1400 µL disposable container that holds a sample. To facilitate the positive
identification of samples, sample cups can be placed in sample tubes that have bar
code labels.
sample rack An accessory that holds six primary tubes, aliquot tubes, or sample cups. Any
combination of tubes and cups can be used in a sample rack.
SCM See system control module, page 1713.
self blank (c‑series) The blank read time used to correct the absorbance for sample coloring
because of lipemia, hemolysis, bilirubin, and so forth.
shutdown A procedure that is used to turn off the power to the processing module and the
system control module.
SID The bar code number or identification assigned to a specimen. An SID can have from
1 through 20 alphanumeric characters.
single-constituent An assay-specific sample that contains known concentrations of an analyte that is

calibrator used for assay calibration.
single-constituent An assay-specific sample that contains known concentrations of an analyte.

control
SmartWash feature (c‑series) An additional wash process (when needed) for reagent probes, sample
probes, and cuvettes. The SmartWash feature is used during assay processing to
reduce interference (carryover) between specific assay combinations.
solenoid valves (c‑series) Six valves that are located at the top of the sample and reagent syringe
drives that open or close as required for flushing, aspiration, and dispense.
spline method (c‑series photometric) A full calibration method that uses a reagent blank and three to
six calibrators to generate a calibration curve that has multiple sections. Each section
of the calibration curve is interpolated by using a polynomial equation so that the
adjoining sections are connected smoothly.
startup A procedure used to home motors and initialize the processing module and the
reagent and sample manager (RSM). When the procedure is performed, the
instrument statuses of the processing module and the RSM transition from Stopped to
Idle.
supervisor logon An access level (operator ID and personal identification number) for the system
control module that is used to perform supervisor functions such as configure
automatically generated reports; configure settings for quality control, audio, and
calibrators; and configure user-defined maintenance.

80000071-105 - 2018-09-10
Glossary
supply and pump (Alinity c) The onboard storage area for processing module pumps, bulk solutions, and
center sample and reagent syringes and drives.
supply center (Alinity i) The onboard storage area for bulk solutions and reaction vessel solid waste.
system administrator An access level (operator ID and personal identification number) for the system
logon control module that is used to perform administrator functions such as configure
system settings, approve maintenance logs, install and uninstall assays, and accept
Abbott Mail items.
system control A computer system that provides the software interface to the Alinity ci‑series and
module provides an interface to a host or middleware computer.
system log An electronic log that displays and stores a record of error-related and informational
message codes that can be used to troubleshoot problems associated with system
performance and results reporting. The maximum capacity of the system log is
120,000 messages. When the maximum capacity is reached, messages are replaced
on a first-in and first-out basis.
System menu A command on the System menu that represents an available screen. When a
command System menu command is selected, the associated screen is displayed.
system software The software application that controls the operation of an Alinity ci‑series.
technical service A document that is used to notify Abbott Service and Support personnel about how to
bulletin make a physical change or modification to an instrument that requires implementation
by Abbott personnel.
time-out An error that may occur for software communication functions when a defined time
limit is exceeded while the operator waits for a response from a device.
touchscreen monitor The main interface between the operator and the Alinity ci‑series that allows the
operator to select icons, buttons, menu commands, and other screen elements.
Trigger Solution (i‑series) A solution that contains 0.35N sodium hydroxide solution that produces the
chemiluminescent reaction that provides the final read.
Trigger Solution level (i‑series) An assembly with a magnetic float sensor that indicates when the liquid level
sensor in the Trigger Solution reservoir is low.
TSB See technical service bulletin, page 1713.
uninterrupted power An optional component that provides a temporary, continuous flow of power to the
supply user interface computer during a power failure, which helps the operator to save data
as necessary and to perform a controlled shutdown procedure.
unreleased result A specimen, control, or calibration result that has not been reviewed and released.
Unreleased results include test orders, tests in process, exceptions, and system-
ordered constituents for calculated assays. Most unreleased results can be viewed on
the Sample Status screen and the Results screen, but constituent results cannot be
displayed on the Results screen.
UPS See uninterrupted power supply, page 1713.

80000071-105 - 2018-09-10
Glossary
USB flash drive A removable flash memory device that can be inserted into a USB port on the user
interface computer. A USB flash drive can be used to import calibrator set data,
import multiconstituent control data, export and import c‑series photometric assay
files, and save system logs for troubleshooting purposes.
use cal factor blank (c‑series photometric) A full calibration method that uses the factor and reagent blank
method of a calibration curve generated for another assay (reference assay) to calculate
results. This method is used when two or more assays use the same reagent and have
the same sample volume to reagent volume ratios.
user-defined assay (c‑series) An assay that uses an assay parameter file that is configured manually in
the system software by the operator.
user-defined reagent (c‑series) A reagent that is manually filled in a one-dimensional bar-code-labeled

reagent cartridge for use with a user-defined assay.
vial rack An accessory that holds six open vials of calibrators or controls for immediate use.
Vial racks cannot be stored in the reagent carousel.
vortexer (i‑series) A device that mixes the reaction mixture in a reaction vessel to suspend
paramagnetic microparticles. The process path has three vortexers. The pretreatment
path has one vortexer.
wash buffer (i‑series) A solution that is composed of Concentrated Wash Buffer and purified water
and that contains phosphate-buffered saline. Wash buffer is pumped to sample and
reagent pipettor assemblies and to wash zones during assay processing.
wash solution pump (Alinity c) A syringe drive pump in the supply and pump center that delivers Alkaline
Wash and Acid Wash solutions to the cuvettes during daily operation and maintenance
procedures.
wash zone assembly (Alinity i) A device that dispenses the wash buffer into reaction vessels (RVs), and
removes and discards the unbound analyte from the reaction mixture in the RVs. The
Alinity i processing module has two wash zone assemblies.
wash zone diverter (Alinity i) A device in the processing center that directs reaction vessels (RVs) to one
of two lanes. One lane moves RVs through the wash zone where a wash occurs. The
other lane moves RVs to the wash zone bypass lane where a wash does not occur.
water bath (Alinity c) An incubator that surrounds the reaction cuvettes and maintains the reaction
temperature. The temperature of the water bath is 37°C.
Water Bath Additive (c‑series) An antimicrobial solution that is used to prevent and control microbial
contamination in the water bath. During the daily maintenance procedure, the solution
is dispensed into the water bath.
water bath overflow (Alinity c) A waste collection compartment that receives overflow from the water bath,
and waste area excess water from the sample pipettor, and liquid waste from the ICT Reference
Solution cup.
Westgard rules Control rules that use various standard deviation limits to monitor the performance of
the Alinity ci‑series by detecting trends or shifts.

80000071-105 - 2018-09-10
Glossary
window A screen element that provides more information or functions related to the active
screen. A window can be accessed by tapping a button on the screen. The window
displays on top of, or in front of, the screen.

80000071-105 - 2018-09-10
Glossary
NOTES

80000071-105 - 2018-09-10
Revision history
Document control numbers Revision date Content revised

80000071-105 (Customer) 2018-09-10 Read me first; System documentation;
Sections 1, 2, 4, 5, 6, 8, 9, and 10;
Appendices A, B, C, and D; Glossary

80000071-105 - 2018-09-10
Revision history
NOTES

80000071-105 - 2018-09-10
Index
Index
1205 Wash Buffer Dilution Assembly Test (i-series)
1 mL syringes (c-series) diagnostic description, 903
replacing, 958 1206 Pre-Trigger and Trigger Valves and Pumps Test
1-point adjustment (c-series photometric) (i-series)
description of, 782 diagnostic description, 903
1000 Optics Background (i-series) 1207 Trigger Wash Cup Dispense Test (i-series)
diagnostic description, 893 diagnostic description, 904
1005 Shutter Test (i-series) 1208 Wash Zone Valves, Pumps, and Motors Test (i-
diagnostic description, 893 series)
1100 Pipettor Motors Test (i-series) diagnostic description, 904
diagnostic description, 894 1209 Empty Bulk Solution Reservoirs (i-series)
1105 Pipettor Syringe and Pump Test (i-series) diagnostic description, 905
diagnostic description, 894 1210 Pre-Trigger Precision and Accuracy (i-series)
1111 Sample Pipettor Check and Calibration (i-series) diagnostic description, 905
diagnostic description, 895 1211 Trigger Precision and Accuracy (i-series)
1112 R1 Pipettor Check and Calibration (i-series) diagnostic description, 906
diagnostic description, 895 1221 Wash Zone 1 Precision and Accuracy (i-series)
1113 R2 Pipettor Check and Calibration (i-series) diagnostic description, 906
diagnostic description, 896 1222 Wash Zone 2 Precision and Accuracy (i-series)
1115 Sample Pipettor LAS Calibration (i-series) diagnostic description, 906
diagnostic description, 896 1231 Wash Zone 1 Residual Volume (i-series)
1120 Sample Pipettor Syringe Precision and Accuracy
diagnostic description, 907
(i-series) 1232 Wash Zone 2 Residual Volume (i-series)
1121 R1 Pipettor Syringe Precision and Accuracy (i- 1261 Wash Zone 1 Wash Monitoring (i-series)
series) diagnostic description, 908
diagnostic description, 897 1262 Wash Zone 2 Wash Monitoring (i-series)
1122 R2 Pipettor Syringe Precision and Accuracy (i- diagnostic description, 908
series) 1270 Bulk Solutions Motors and Sensors Test (i-
diagnostic description, 898 series)
1130 Sample Pipettor Pump Precision and Accuracy diagnostic description, 909
(i-series) 1300 Temperature Status (i-series)
1131 R1 Pipettor Pump Precision and Accuracy (i- 1400 RV Loader and Sensors Test (i-series)
series) diagnostic description, 910
diagnostic description, 899 1505 Diverter Test (i-series)
1132 R2 Pipettor Pump Precision and Accuracy (i- diagnostic description, 911
series) 1510 Vortexer Test (i-series)
1160 Liquid Level Sense Test (i-series) 1515 Process Path Motors Test (i-series)
1161 Pipettor Probe Move (i-series) 1520 RV Load and Unload Test (i-series)
1200 Flush and Prime Fluidics (i-series) 1525 Process Path Sensors Test (i-series)
1201 Induction Heater Test (i-series) 1600 RSM Transport Calibration
1202 Wash Cup Valves Test (i-series)
diagnostic description, 903

80000071-105 - 2018-09-10
Index
1610 Reagent and Sample Manager Test 4103 R1 Pipettor Calibration (c-series)
diagnostic description, 917 description of, 878
1620 RSM Bar Code Reader Test 4104 R2 Pipettor Calibration (c-series)
1630 Sample Positioner Test (i-series) 4106 Component Move (c-series)
1631 Sample Positioner Test (c-series) 4107 Sample Pipettor LAS Calibration (c-series)
1635 RSM Transport Test 4109 Probe Alignment Test (c-series)
1690 Reagent and Sample Manager Initialization 4110 Crash Sensor Test (c-series)
1703 Reagent Supply Center Test (i-series) 4113 Pipettor Check (c-series)
1715 Reagent Carousel and Reagent Transport 4205 Flush Water Lines (c-series)
Calibration (i-series) diagnostic description, 882
diagnostic description, 914 4206 Flush Bulk Solutions (c-series)
1805 RV Waste Sensor Test (i-series) diagnostic description, 883
diagnostic description, 915 4207 Move Cuvette Washer (c-series)
1830 Buffer Run (i-series) diagnostic description, 883
diagnostic description, 915 4208 Probe and Mixer Wash (c-series)
1890 Processing Module Initialization (i-series) diagnostic description, 883
diagnostic description, 916 4212 Bulk Solution Sensor Test (c-series)
1D reagent bar code labels (c-series) diagnostic description, 884
guidelines, 465 4213 Liquid Level Sense Test (c-series)
1D reagent bar code report diagnostic description, 884
printing, 630 4301 Temperature Status (c-series)
2-point adjustment (c-series photometric) diagnostic description, 885
description of, 783 4701 Reagent Carousel Home (c-series)
2500 Daily Maintenance (i-series) diagnostic description, 886
maintenance description, 868 4703 Reagent Supply Center Test (c-series)
2620 Manual Pipettor Probe Cleaning (i-series) diagnostic description, 887
maintenance description, 869 4715 Reagent Transport Calibration (c-series)
2625 Manual Wash Zone Probe Cleaning (i-series) diagnostic description, 887
maintenance description, 870 4801 Module Initialization (c-series)
2630 Manual Wash Cup Cleaning (i-series) diagnostic description, 888
maintenance description, 870 4803 Voltage Test (c-series)
2850 Air Filter Cleaning (i-series) diagnostic description, 888
maintenance description, 871 4PLC data reduction methods (i-series)
2920 Manual RSM Transport Cleaning description of, 787
maintenance description, 872 x residual minimization (x-weighted), 787
2925 Manual RSM Loading Area and Positioner y residual minimization (y-weighted), 787
Cleaning (i-series) 5002 Mixer Vibration Test (c-series)
maintenance description, 871 diagnostic description, 889
4001 Optics Trigger Sensor Check (c-series) 5003 Clean Cuvettes - Manually (c-series)
4002 Absorbance Reads (c-series) 5004 Reaction Carousel Home and Move (c-series)
4005 Cuvette Integrity Test (c-series) 5005 Exchange Water in Bath (c-series)
4102 Sample Pipettor Calibration (c-series) 5006 Reaction Carousel Calibration (c-series)

80000071-105 - 2018-09-10
Index
5101 Flush ICT Reference Solution Cup (c-series) Abbott Mail Inbox screen
5102 Flush ICT Module (c-series) Abbott Mail Inbox screen, All tab
diagnostic description, 892 element descriptions, 539
5501 Daily Maintenance (c-series) Abbott Mail Inbox screen, Assay Files tab
maintenance description, 858 element descriptions, 540
5601 Clean Cuvettes with Detergent A (c-series) Abbott Mail Inbox screen, Assay Inserts tab
5701 Clean ICT Drain Tip (c-series) Abbott Mail Inbox screen, Calibrator Data tab
5801 Sample Syringe Maintenance (c-series) Abbott Mail Inbox screen, Search flyout
5802 Wash Solution Syringe Maintenance (c-series) Abbott Mail Inbox screen, System Updates tab
5803 Reagent Syringe Maintenance (c-series) Abbott Mail screen
maintenance description, 862 description of, 214
5806 Change Lamp (c-series) element descriptions, 214
maintenance description, 862 AbbottLink
5808 Inspect Wash Cup Tubing (c-series) data usage statement, 23
maintenance description, 863 restarting, 537
5833 Change 1 mL Syringes (c-series) AbbottLink Connection Status flyout
5834 Check and Change ICT Check Valves (c-series) element descriptions, 537
maintenance description, 864 AbbottLink screen
5835 Check and Clean High-Concentration Waste description of, 243
Sensor (c-series) element descriptions, 244
maintenance description, 864 absorbance data for results
5901 Clean Wash Cups (c-series) viewing, 726
maintenance description, 865 absorbance data reduction method (c-series
5906 Clean Sample and Reagent Probes (c-series) photometric)
5907 Clean Mixers (c-series) Absorbance Data Report (c-series)
5908 Clean Cuvette Washer Nozzles (c-series) absorbance range (c-series photometric)
5910 Wash Cuvettes (c-series) access levels
maintenance description, 867 descriptions of, 172
5925 Manual RSM Loading Area and Positioners operator, 172
Cleaning (c-series) accessing
maintenance description, 867 samples that have tests in process, 649
accessing configuration screens
A Configure screen, Assay tab, 250
Configure screen, Computer tab, 216
Abbott Mail Configure screen, General tab, 168
accepting items, 553 Configure screen, Maintenance & Diagnostics tab,
configuring, 216 367
declining system updates, 556 accessories
deleting items, 554 racks, 157
printing documentation, 553 reagent cartridge with empty bottles (c-series), 158
viewing documentation, 553 required, 157
viewing items, 552 trays, 158

80000071-105 - 2018-09-10
Index
Acid Probe Wash (c-series) SCM, 60

replacing and updating inventory, 581 system characteristics, 444
activating What's new, 14
users, 177 workstation configuration, 56
Add Comment flyout Alinity ci-series Calibrator/Control Replacement Caps
element descriptions, 513 description of, 149
Add Note flyout illustration of, 149
element descriptions, 513 Alinity ci-series sample cups
Add Printer flyout illustrations and measurement, 473
element descriptions, 193 Alinity i
Add Result flyout description of, 102
element descriptions, 281 illustration of front view, 102
adding illustration of rear view, 102
assay from a quality control, 357 procedure key, 58
comment to an order, 668 reagent carousel, 134
comments to a system update, 393 reagent supply center, 133
comments to Levey-Jennings points, 739 supply center, 128
comments to results or exceptions, 702 Alinity PRO
printer, 195 configuring, 243
test to a specimen order, 689 Alinity PRO Connection Status flyout
adjustment calibration (c-series photometric) description of, 534
1-point adjustment, 781 element descriptions, 534
2-point adjustment, 781 Alinity PRO screen
blank adjustment, 782 description of, 241
description of, 781 element descriptions, 242
adjustment calibration (i-series) Alinity system security
description of, 788 description of, 19
adjustment methods (i-series) responsibility for, 19
curve shape, 791 Alinity system software
linear transformation, 790 description of user interface, 139
parameter, 790 descriptions of screen elements, 140
ratio technique, 789 illustration of user interface, 139
agency approvals overview, 139
description of, 26 aliquot sample tubes
Alert Center illustration of, 473
deleting a message, 1035 specifications, 473
Alert Center flyout verifying sample volume with the sample gauge, 643
description of, 1033 volumes, 476
element descriptions, 1033 animations
Alinity c playing, 47
description of, 76 approving
illustration of front view, 76 maintenance log, 856
illustration of rear view, 76 archive
procedure key, 58 calibrations, 762
reagent carousel, 101 results, 761
reagent supply center, 100 Archive File Location window
supply and pump center, 94 element descriptions, 760
Alinity ci-series Archive flyout
hardware overview, 56 description of, 759
optional components, 136 element descriptions, 759
primary components, 56 assay applications (c-series photometric)
RSM, 70 description of, 1539

80000071-105 - 2018-09-10
Index
reagent carryover evaluation, 1605 color correction, 1574

user-defined assay parameters, 1540 creating a user-defined assay, 1598
assay calibration description of, 1540
guidelines, 768 dispense types, 1577
mandatory, 768 FlexRate method, 1578
optional, 768 linearity flagging, 1581
system verification, 795 maximum absorbance variation, 1583
types and methods, 769 maximum curve fit, 1585
validity checks, 795 photometric timing table, 1586
viewing status, 805 rate linearity percent, 1587
assay claims reaction check, 1590
verification of, 1471 sample dilution, 1592
assay display order self blank, 1595
configuring, 335 assay parameters (c-series photometric)
Assay Display Order screen editing calibration settings, 293
description of, 333 editing general settings, 286
element descriptions, 334 assay parameters (c-series potentiometric)
assay file reagent statuses editing calibration settings, 294
descriptions of, 325 editing general settings, 289
assay file request statuses assay parameters (calculated)
descriptions of, 549 editing general settings, 291
assay files assay parameters (i-series)
deleting, 328 editing calibration settings, 296
installing, 325 editing general settings, 290
requesting, 554 Assay Parameters screen
uninstalling, 327 Create Assay flyout element descriptions, 1542
assay files (c-series) description of, 251
exporting, 331 element descriptions, 252
importing, 332 New Cal Set flyout element descriptions, 1563
Assay Information Report New Reagent flyout element descriptions, 1553
element descriptions, 1617 View/Edit Reagent flyout element descriptions, 1554
assay insert statuses Assay Parameters screen (c-series photometric, user
descriptions of, 621 defined)
assay inserts element descriptions, 1541
printing, 635 Assay Parameters screen, Calibration tab
viewing, 635 element descriptions, 274
Assay Installation Report Assay Parameters screen, Calibration tab (c-series
element descriptions, 1618 photometric)
Assay Parameter Report (c-series) element descriptions, 266
element descriptions, 1619 Assay Parameters screen, Calibration tab (c-series
Assay Parameter Report (Calculated) potentiometric)
element descriptions, 1638 element descriptions, 272
Assay Parameter Report (i-series) Assay Parameters screen, General tab
element descriptions, 1632 element descriptions, 262, 265
Assay Parameter screen, Calibration tab (c-series Assay Parameters screen, General tab (c-series
photometric, user defined) photometric, user defined)
assay parameters Assay Parameters screen, General tab (c-series
editing result settings, 297 photometric)
assay parameters (c-series photometric, user defined) element descriptions, 253
absorbance range, 1578
calculating a calibration factor, 1597

80000071-105 - 2018-09-10
Index
Assay Parameters screen, General tab (c-series automated dilution verification

potentiometric) c-series worksheet, 1507
element descriptions, 260 i-series worksheet, 1508
Assay Parameters screen, Results tab automated ordering
element descriptions, 276 by a host, 652
Assay Parameters screen, Results tab (c-series calibrations, 656
photometric, user defined) capabilities, 652
element descriptions, 1564 controls, 653
Assay Parameters screen, Retest Rules tab description of, 652
element descriptions, 282 specimens, 658
Assay Parameters screen, SmartWash tab (c-series) automated retest of specimens
assay processing (c-series) automatic backup
principles of operation, 414 configuring, 240
assay processing (i-series) Automatic Backup screen
principles of operation, 433 description of, 238
assay protocol types (c-series) element descriptions, 238
dilution protocol, 420 automatic processing module activities
ICT protocol, 422 automatic rotation of the reagent carousel (c-series),
one-reagent protocol, 417 163
pretreatment protocol, 421 description of, 161
two-reagent protocol, 419 processing module wash (c-series), 162
assay protocol types (i-series) system flush (c-series), 161
One Step 25, 434 system flush (i-series), 161
pretreatment, 437 system prime (i-series), 162
STAT for One Step 11, 439 automatic rotation of the reagent carousel (c-series)
STAT for Two Step 4-4, 440 description of, 163
Two Step 18-4, 435
assay status of a correlation assay B
changing, 301
assigning backup
temporary priority positions to load racks and copying to a USB flash drive, 383
cartridges, 606 performing manually, 382
ASTM communication Backup flyout
configuring, 233 element descriptions, 381
verifying, 1468 Backup/Restore screen
ASTM Communication screen description of, 379
element descriptions, 232 bar code label guidelines
audio alert 1D reagent (c-series), 465
configuring, 224 1D reagent labels (c-series), bar code print quality
Audio Settings screen of, 465
description of, 223 1D reagent labels (c-series), density of, 465
element descriptions, 223 1D reagent labels (c-series), label stock for, 465
authentication 1D reagent labels (c-series), length of, 465
configuring, 221 1D reagent labels (c-series), printer type for, 465
automated calibration ordering 1D reagent labels (c-series), quiet zone for, 465
description of, 656 1D reagent labels (c-series), symbology for, 465
automated control ordering sample labels, bar code print quality of, 469
description of, 653 sample labels, density of, 469
automated dilution sample labels, label stock for, 469
verifying, 1506 sample labels, length of, 469

80000071-105 - 2018-09-10
Index
sample labels, printer type for, 469 bulk solutions (i-series)

sample labels, quiet zone for, 469 Concentrated Wash Buffer, 151
sample labels, ratio for, 469 description of, 151
sample labels, symbology for, 469 illustration of, 151
bar code label requirements Pre-Trigger Solution, 151
1D reagent bar code label data format (c-series), Trigger Solution, 151
466
1D reagent labels (c-series), placement, 468 C
sample labels, placement of, 471
sample labels, SID length of, 470 c-series
bar code scanner electrical specifications and requirements, 456
specifications, 462 optical specifications, 458
Bar Codes screen principles of operation, 402
description of, 198 processing module capacities, 450
element descriptions, 199 processing module characteristics, 444
bar-coded specimens for batch processing processing module specifications, operational, 447
loading, 597 Cal/QC Inventory screen
batteries description of, 587
precautions, 827 element descriptions, 588
biological hazards Cal/QC Inventory screen, Search flyout
blank adjustment (c-series photometric) Cal/QC Ordering screen
bulk solution inventory element descriptions, 340
configuring low alert settings, 210 calculated assays
bulk solution inventory low alert settings creating, 302
configuring, 210 calculating
bulk solution reservoir area (Alinity c) calibration factor (c-series photometric), 1597
components, 98 precision verification value, 1492
description of, 98 calibration
illustration of, 98 guidelines, 768
bulk solution reservoirs (c-series) mandatory, 768
emptying, 1452 optional, 768
bulk solution reservoirs (i-series) system verification, 795
emptying, 1456 types and methods, 769
bulk solution storage area (Alinity c) validity checks, 795
components, 97 viewing status, 805
description of, 97 Calibration Details Report (c-series linear)
illustration of, 97 element descriptions, 1642
bulk solution storage area (Alinity i) Calibration Details Report (c-series potentiometric)
components, 129 element descriptions, 1645
description of, 129 Calibration Details Report (c-series use cal factor
illustration of, 129 blank)
bulk solutions element descriptions, 1648
replacing and updating inventory, 579 Calibration Details Report (i-series adjust)
bulk solutions (c-series) element descriptions, 1651
Acid Wash Solution, 150 Calibration Details Report (i-series full)
Alkaline Wash Solution, 150 element descriptions, 1654
description of, 150 Calibration Details Report (i-series index)
ICT Reference Solution, 150 element descriptions, 1657
illustration of, 150 calibration expiration
overriding, 341

80000071-105 - 2018-09-10
Index
calibration factor (c-series photometric) transmitting to the host, 806

calculating, 1597 calibrator data
calibration methods deleting, 315
c-series photometric, 774 importing, 314
c-series potentiometric, 769 calibrator data (c-series)
i-series 4PLC data reduction, 787 editing, 317
i-series cutoff assay data reduction, 792 calibrator data (i-series)
i-series description, 784 editing, 319
i-series linear regression data reduction, 786 calibrator data files
i-series point-to-point data reduction, 785 requesting, 555
i-series reference data reduction, 792 calibrator import statuses (c-series)
calibration ordering settings descriptions of, 317
configuring, 341 calibrator lot
calibration review deleting, 316
description, 795 viewing data, 310
calibration sample processing calibrator lot expiration
description of, 638 overriding, 341
Calibration Status Details screen calibrator master lot (c-series)
description of, 800 creating, 311
element descriptions, 800 calibrator master lot (i-series)
Calibration Status screen creating, 313
description of, 796 calibrator sample processing
element descriptions, 796 configuring, 209
Calibration Status screen, Search flyout Calibrator Set screen
calibration statuses element descriptions, 307
descriptions of, 804 Calibrator Set View/Edit screen
calibration storage element descriptions, 308
active calibrations, 793 calibrator value sheet (c-series)
description, 793 printing, 320
failed calibrations, 794 viewing, 320
inactive calibrations, 794 calibrator vials
Calibration Summary Report loading for immediate use, 646
element descriptions, 1660 loading for onboard storage, 624
calibration types onboard storage criteria, 642
c-series description, 774 preparing for immediate use, 646
c-series full, 775 preparing for onboard storage, 624
c-series photometric 1-point adjustment, 781 calibrators
c-series photometric 2-point adjustment, 781 Alinity c, 149
c-series photometric blank adjustment, 781 Alinity c ICT, 149
i-series adjustment, 788 Alinity ci-series Calibrator/Control Replacement
i-series description, 784 Caps, 149
i-series full, 785 Alinity i, 149
i-series index, 792 description of, 149
calibration verification illustration of, 149
c-series worksheet, 1498 calibrators troubleshooting
i-series worksheet, 1499 c-series, 1029
performing, 1497 i-series, 1030
calibrations cancelling
archiving, 762 pending transmissions, 531
automated ordering, 656 unloading a rack or a cartridge, 632
failing, 806

80000071-105 - 2018-09-10
Index
capacities Comments flyout

c-series, 450 element descriptions, 388
i-series, 451 comments, adding
reagent and sample manager (RSM), 452 to Levey-Jennings points, 739
software data storage, 449 component replacement
cartridge statuses c-series processing center, 920
descriptions of, 617 c-series supply and pump center, 957
cartridges description of, 920
unloading from the reagent carousel, 1449 i-series processing center, 989
cartridges on a specific processing module i-series supply and pump center, 1008
loading, 602 optional, 1017
changing computer and interface
assay status of a correlation assay, 301 specifications, 462
default printer, 197 Configure screen, Assay tab
sample bar code labels, 200 description of, 250
user PINs, 182 Configure screen, Computer tab
check valves (c-series) description of, 216
replacing, 961 Configure screen, General tab
checking description of, 168
system operation after installation, 166 Configure screen, Maintenance & Diagnostics tab
chemical hazards description of, 367
dry ice, 825 configuring
general precautions, 823 Abbott Mail, 216
overview of, 823 Alinity PRO, 243
Clear Control Failure flyout assay display order, 335
element descriptions, 746 ASTM communication, 233
clearances audio alert, 224
external waste pump, 464 authentication, 221
system, 455 automatic backup, 240
clearing calibration ordering settings, 341
control failures, 748 control ordering settings, 341
messages, 1035 date, 221
CMIA method (i-series) distance alert settings, 248
CMIA technology and reaction sequence, 428 HL7 communication, 231
data reduction calculation, 433 host interface settings, 228
optical system and measurement sequence, 431 ICT module (c-series), 189
principles of operation, 428 language, 221
CMIA reaction sequence (i-series) LAS communication, 235
description of, 428 liquid waste container (c-series), 189
illustration of, 428 message alert, 224
CMIA technology (i-series) module name (c-series), 189
description of, 428 module name (i-series), 190
codes name, 221
processing, 691 number format, 221
color correction (c-series photometric) onboard calibrators and controls (c-series), 189
description of, 1574 onboard calibrators and controls (i-series), 190
comment optics values (i-series), 190
adding to an order, 668 panels, 338
comments personal display theme, 182
adding to a system update, 393 print screen file output destination, 213
adding to notes, 516 printer, 195
adding to results or exceptions, 702 priority sections, 189

80000071-105 - 2018-09-10
Index
reagent and sample manager, 189 control lot expiration

reports, 213 overriding, 341
retest options, 189 control lot number
retest rules, 299 number of characters, 349
sample bar code checksums, 200 control name
sample bar code labels, 200 maximum lot numbers, 349
sample bar code length, 200 control ordering settings
sample bar code start/stop characters, 200 configuring, 341
sample bar code type, 200 control results
screen time-out, 221 releasing, 704
shortcut icons, 237 control sample processing
SmartWash settings (c-series), 1608 description of, 637
speaker volume, 221 control summary details
STAT protocol (i-series), 190 viewing, 750
system, 168 Control Summary Details screen
time, 221 description of, 743
Westgard rules, 366 element descriptions, 743
consumable inventory management control vials
description of, 561 loading for immediate use, 646
consumable list numbers loading for onboard storage, 624
description of, 1530 onboard storage criteria, 642
consumables preparing for immediate use, 646
Alinity ci-series Calibrator/Control Replacement preparing for onboard storage, 624
Caps, 149 controls
bulk solutions (c-series), 150 Alinity ci-series Calibrator/Control Replacement
bulk solutions (i-series), 151 Caps, 148
calibrators, 149 automated ordering, 653
controls, 148 description of, 148
ICT module (c-series), 154 illustration of, 148
list numbers (c-series), 1531 multiconstituent, 148
list numbers (i-series), 1532 single-constituent, 148
maintenance solutions (c-series), 153 controls troubleshooting
onboard solutions (c-series), 152 c-series, 1029
probe conditioning solution (i-series), 154 i-series, 1030
reaction vessels (i-series), 155 Copy Backup flyout
reagent kits and components, 146 element descriptions, 381
required, 146 corrective action procedure, reagent and sample
requirements for use, 812 manager (RSM)
sample cups, 156 removing racks from the sample positioners, 1464
consumables troubleshooting corrective action procedures
c-series, 1025 miscellaneous, 1449
i-series, 1027 processing module, 1449
Contents tab reagent and sample manager (RSM), 1464
Help window description, 39 user interface (UI) computer, 1465
Help window illustration, 39 corrective action procedures, processing module
procedure for use, operations manual, 46 emptying the bulk solution reservoirs (c-series), 1452
Control Create/Edit screen emptying the bulk solution reservoirs (i-series), 1456
element descriptions, 343 emptying the diluted wash buffer reservoir (i-series),
control failures 1460
clearing, 748 enabling or disabling the ICT module (c-series),
control lot 1463
manually creating, 349

80000071-105 - 2018-09-10
Index
manually unloading a cartridge or rack from the element descriptions, 397

reagent carousel, 1449 curve shape adjustment methods (i-series)
corrective action procedures, user interface (UI) description of, 791
computer customer service
verifying the ASTM communication, 1468 contacting, 20
verifying the HL7 communication, 1466 cutoff assay data reduction method (i-series)
verifying the LAS communication, 1467 description of, 792
Create Assay flyout one-point qualitative (index formula) method, 792
element descriptions, 1542 two-point qualitative (index formula) method, 792
Create New User screen cuvette dry tip (c-series)
element descriptions, 173 replacing, 945
Create Order screen cuvette segments (Alinity c)
Create Order screen, Calibration tab illustration of, 85
element descriptions, 679 cuvette segments (c-series)
Create Order screen, Calibration tab, Assay Options replacing, 941
flyout cycling power
element descriptions, 681 processing module, 484
Create Order screen, Control tab reagent and sample manager (RSM), 484
element descriptions, 676 system, 480
Create Order screen, Control tab, Assay Options flyout system control module, 480
element descriptions, 677
Create Order screen, Specimen tab, Assay Options D
flyout
element descriptions, 675 daily operations
Create Order screen, Specimen tab, Bar-Coded Batch c-series solutions, 577
element descriptions, 671 i-series solutions, 578
Create Order screen, Specimen tab, Patient Details data
flyout filtering, 757
element descriptions, 673 searching, 757
Create Order screen, Specimen tab, Single Specimen data reduction calculation
element descriptions, 669 c-series photometric description, 407
creating c-series potentiometric description, 413
bar-coded batch specimen orders, 684 i-series description, 433
calculated assays, 302 date
calibration orders, 688 configuring, 221
control lot manually, 349 declining
control orders, 686 system update, 392
Levey-Jennings graphs, 747 decontamination
new calibrator master lot (c-series), 311 bar code scanner, 874
new calibrator master lot (i-series), 313 external components, 873
new users, 174 monitor, 874
notes, 514 requirements, 829
quality control lot manually, 349 deleting
single specimen orders, 682 assay files, 328
user-defined assays (c-series photometric), 1598 assay from a quality control, 358
user-defined maintenance procedures, 375 calibrator data, 315
Current Firmware screen calibrator lot, 316
description of, 398 exceptions, 727
element descriptions, 398 imported quality control data, 363
Current Software screen message from the Alert Center, 1035
description of, 397 messages from the Alert Center, 1035

80000071-105 - 2018-09-10
Index
notes, 517 E
panel, 339
print job, 533 Edit Printer flyout
quality control lots, 359 element descriptions, 193
quality controls, 360 Edit Result flyout
sample results, 727 element descriptions, 281
tests from sample orders, 692 Edit User screen
Details for Log flyout element descriptions, 175
element descriptions, 854 editing
Detergent A (c-series) calibration settings of assay parameters (c-series
replacing and updating inventory, 581 photometric), 293
Detergent B (c-series) calibration settings of assay parameters (c-series
configuring modules, 210 potentiometric), 294
Diagnostic History Report calibration settings of assay parameters (i-series),
element descriptions, 1661 296
diagnostic procedure calibrator data (c-series, 317
performing, 849 calibrator data (i-series), 319
diagnostics general settings of assay parameters (c-series
overview of, 838 photometric), 286
diluent (c-series) low alert setting general settings of assay parameters (c-series
configuring, 208 potentiometric), 289
diluted wash buffer reservoir (i-series) general settings of assay parameters (calculated),
emptying the, 1460 291
dilution protocol (c-series) general settings of assay parameters (i-series), 290
assay protocol type, 420 notes, 515
dimensions panel definition, 338
external waste pump, 464 printer, 196
disabling quality controls, 353
LAS connection, 536 result settings of assay parameters, 297
reagent cartridge, 634 SmartWash settings (c-series), 1610
sample processing, 221 user-defined maintenance procedures, 376
disclaimers users, 176
description of, 23 electrical hazards
dispense types (c-series) awareness of, 832
description of, 1577 electrical safety
displaying requirements, 832
values for Levey-Jennings points, 738 electrical specifications
distance alert system control module (SCM), 456
configuring settings, 248 electromotive force measurement data reduction (c-
description of, 68 series potentiometric)
illustration of, 68 calculation, 769
verifying the function, 249 description of, 769
Distance Alert screen element descriptions
description of, 245 Abbott Mail Inbox screen, All tab, 539
element descriptions, 246 Abbott Mail Inbox screen, Assay Files tab, 540
downloading Abbott Mail Inbox screen, Assay Inserts tab, 541
system update software, 391 Abbott Mail Inbox screen, Calibrator Data tab, 543
dry ice Abbott Mail Inbox screen, Search flyout, 545
precautions, 825 Abbott Mail Inbox screen, System Updates tab, 542
Abbott Mail screen, 214
AbbottLink Connection Status flyout, 537
AbbottLink screen, 244

80000071-105 - 2018-09-10
Index
Absorbance Data Report (c-series), 1614 Calibration Details Report (c-series use cal factor
Add Comment flyout, 513 blank), 1648
Add Note flyout, 513 Calibration Details Report (i-series adjust), 1651
Add Printer flyout, 193 Calibration Details Report (i-series full), 1654
Add Result flyout, 281 Calibration Details Report (i-series index), 1657
Alert Center flyout, 1033 Calibration Status Details screen, 800
Alinity PRO Connection Status flyout, 534 Calibration Status screen, 796
Alinity PRO screen, 242 Calibration Status screen, Search flyout, 798
Archive File Location window, 760 Calibration Summary Report, 1660
Archive flyout, 759 Calibrator Set screen, 307
Assay Display Order screen, 334 Calibrator Set View/Edit screen, 308
Assay Information Report, 1617 Clear Control Failure flyout, 746
Assay Installation Report, 1618 Comments flyout, 388
Assay Parameter Report (c-series), 1619 Control Create/Edit screen, 343
Assay Parameter Report (Calculated), 1638 Control Summary Details screen, 743
Assay Parameter Report (i-series), 1632 Copy Backup flyout, 381
Assay Parameters screen, 252 Create Assay flyout, 1542
Assay Parameters screen (c-series photometric, Create New User screen, 173
user defined), 1541 Create Order screen, Calibration tab, 679
Assay Parameters screen, Calibration tab, 274 Create Order screen, Calibration tab, Assay Options
Assay Parameters screen, Calibration tab (c-series flyout, 681
photometric, user defined), 1556 Create Order screen, Control tab, 676
Assay Parameters screen, Calibration tab (c-series Create Order screen, Control tab, Assay Options
photometric), 266 flyout, 677
Assay Parameters screen, Calibration tab (c-series Create Order screen, Specimen tab, Assay Options
potentiometric), 272 flyout, 675
Assay Parameters screen, General tab, 262, 265 Create Order screen, Specimen tab, Bar-Coded
Assay Parameters screen, General tab (c-series Batch, 671
photometric, user defined), 1543 Create Order screen, Specimen tab, Patient Details
Assay Parameters screen, General tab (c-series flyout, 673
photometric), 253 Create Order screen, Specimen tab, Single
Assay Parameters screen, General tab (c-series Specimen, 669
potentiometric), 260 Current Firmware screen, 398
Assay Parameters screen, Results tab, 276 Current Software screen, 397
Assay Parameters screen, Results tab (c-series Details for Log flyout, 854
photometric, user defined), 1564 Diagnostic History Report, 1661
Assay Parameters screen, Retest Rules tab, 282 Distance Alert screen, 246
Assay Parameters screen, SmartWash tab (c- Edit Printer flyout, 193
series), 1569 Edit Result flyout, 281
ASTM Communication screen, 232 Edit User screen, 175
Audio Settings screen, 223 Exception List Report, 1664
Automatic Backup screen, 238 Export Location Option window, 239
Backup flyout, 381 General Settings screen, 219
Backup/Restore screen, 380 HL7 Communication screen, 230
Bar Codes screen, 199 Home screen, 520
Cal/QC Inventory screen, 588 Host Connection Status flyout, 529
Cal/QC Inventory screen, Search flyout, 589 Host Setup screen, 225
Cal/QC Ordering screen, 340 Import Calibrators screen (c-series), 309
Calibration Details Report (c-series linear), 1642 Import screen, 348
Calibration Details Report (c-series potentiometric), Import/Export Assays screen, Export Files tab (c-
1645 series), 329

80000071-105 - 2018-09-10
Index
Import/Export Assays screen, Import Files tab (c- Quality Control Summary screen, 740
series), 329 Quality Control Summary screen, Search flyout, 742
Install/Uninstall Assays screen, Available Files tab, Reagent Cartridge Details screen, 615
321 Reagent Status Report, 1681
Install/Uninstall Assays screen, Installed Files tab, Reagents and Supplies screen, Reagents/Diluents
323 tab, 202
Install/Uninstall Procedures screen, Available Files Reagents and Supplies screen, Supplies tab, 205
tab, 368 Reagents screen, Current tab, 609
Install/Uninstall Procedures screen, Installed Files Reagents screen, Historical tab, 612
tab, 369 Reagents screen, Search flyout, 614
LAS Communication screen, 234 Report File Location window, 754
LAS Connection Status flyout, 535 Reports screen, 211
Levey-Jennings (Graph) screen, 733 Requested Categories flyout, 549
Log On screen, 507 Rerun List Report, 1683
Log Report, 1666 Rerun Options (Control Order) flyout, 720
Maintenance History Report, 1661 Rerun Options (Specimen Order) flyout, 719
Manual File Request screen, Assay Files tab, 547 Result Details (Specimen and Control) screen, 715
Manual File Request screen, Calibrator Data tab (c- Result Details Report, 1685
series), 548 Result List Report, 1689
Message Details For flyout, 1049 Results screen, Control tab, 710
Modules screen (c-series), 184 Results screen, Exception tab, 711
Modules screen (i-series), 187 Results screen, Search flyout, 713
Modules screen, reagent and sample manager Results screen, Specimen tab, 708
(RSM), 183 Results screen, Unreleased tab, 707
New Cal Set flyout (c-series photometric, user Retest Assays flyout, 286
defined), 1563 Sample Details (Specimen, Control, and Calibrator)
New Reagent flyout (c-series photometric, user screen, 698
defined), 1553 Sample Laboratory Report, 1691
Notepad flyout, 511 Sample Status screen, 693
Order Details (Bar-Coded Batch Specimen) screen, Sample Status screen, Search flyout, 696
666 Select Items window (c-series), 331
Order Details (Single Specimen, Control, and Set PIN flyout, 177
Calibrator) screen, 664 Set Stability flyout, 347
Order List Report, 1669 Shortcuts, 236
Orders screen, 660 Show Picture flyout, 845
Orders screen, Search flyout, 661 Show Video flyout, 844
Panel Definition screen, 336 Supplies screen (c-series), 562
Perform Procedure screen, 843 Supplies screen (i-series), 571
Point Details screen, 736 Supplies screen, Supply Details flyout for ICT
Print flyout, 752 Module (c-series), 569
Printer Queue flyout, 194 Supplies screen, Supply Details flyout for Liquid
Printer Status/Queue flyout, 532 Waste (c-series), 570
Printer Verification flyout, 194 Supplies screen, Supply Details flyout for RV Waste
Printers screen, 191 (i-series), 576
Procedure Report, 1671 Supplies screen, Supply Details flyout for RVs, 575
Procedures Log screen, Diagnostics tab, 853 Supplies screen, Supply Details flyouts for Acid
Procedures Log screen, Maintenance tab, 852 Probe Wash and Detergent A (c-series), 570
Procedures screen, 839 Supplies screen, Supply Details flyouts for Alkaline
QC Analysis Report, 1673 Wash, Acid Wash, and ICT Reference (c-series),
QC Levey-Jennings Report, 1676 567
QC Summary Report, 1679 Supplies screen, Supply Details flyouts for Pre-
Quality Control screen, 343 Trigger, Trigger, and Wash Buffer, 574

80000071-105 - 2018-09-10
Index
System Logs screen, Abbott Mail tab, 1043 evaluating

System Logs screen, All Messages tab, 1044 precision data, 1490
System Logs screen, Configuration tab, 1041 Exception List Report
System Logs screen, Informational tab, 1038 element descriptions, 1664
System Logs screen, Interfaces tab, 1042 exceptions
System Logs screen, Inventory tab, 1039 deleting, 727
System Logs screen, Notifications/Alerts tab, 1036 transmitting to the host, 727
System Logs screen, Search flyout, 1046 excluding
System Logs screen, User Access tab, 1040 Levey-Jennings points, 738
System Update Details Report, 1693 Export Location Option window
System Update Import screen, 388 element descriptions, 239
System Update List Report, 1696 exporting
System Updates screen, 384 c-series assay files, 331
Troubleshooting screen, 395 user-defined maintenance procedures, 378
User Profile screen, 180 users, 179
User-Defined Maintenance Details Report, 1698 exposure
User-Defined Maintenance screen, Create/Edit tab, to hot objects, 836
372 external waste pump
User-Defined Maintenance screen, Export tab, 374 clearances, 464
Users Export screen, 171 description of, 136
Users Import screen, 171 dimensions, 464
Users screen, 170 electrical specifications and requirements, 464
Version Details for Procedure flyout, 841 illustration of, 136
View/Edit Reagent flyout (c-series photometric, user replacing, 1017
defined), 1554 weight, 464
Westgard screen, 365
emergency shutdown F
performing, 502
emptying factor data reduction method (c-series photometric)
bulk solution reservoirs (c-series), 1452 description of, 775
bulk solution reservoirs (i-series), 1456 file update statuses
diluted wash buffer reservoir (i-series), 1460 descriptions of, 324
high-concentration waste bottle and updating flags
inventory (c-series), 583 quality control result, 724
enabling specimen result, 722
LAS connection, 536 FlexRate method (c-series photometric)
reagent cartridge, 634 description of, 1578
enabling or disabling floor loading, typical
ICT module (c-series), 1463 Alinity c, 453
end-point assay reaction curve (c-series photometric) Alinity ci-series, 453
illustration of, 403 Alinity i, 453
end-point assay reactions (c-series photometric) fluidics subsystems troubleshooting
photometric technology, 403 c-series, 1025
environmental specifications and requirements i-series, 1027
Alinity ci-series, 461 flyout
altitude, 461 AbbottLink Connection Status, 537
electrical safety parameters, 461 Alert Center, 1033
humidity, 461 Alinity PRO Connection Status, 534
noise levels, 461 Archive, 759
placement, 461 Host Connection Status, 529
storage and transport, 461 LAS Connection Status, 534
temperature during operation, 461 Notepad, 511

80000071-105 - 2018-09-10
Index
Print, 751 HL7 Communication screen

Printer Status/Queue, 532 description of, 229
Search, 757 element descriptions, 230
full calibration Home screen
c-series description, 775 AbbottLink Connection Status flyout element
i-series description, 785 descriptions, 537
Alert Center flyout element descriptions, 1033
G description of, 519
general requirements Host Connection Status flyout element descriptions,
description of, 810 529
general safety information illustration of, 519
overview, 18 Notepad flyout element descriptions, 511
General Settings screen host connection
description of, 218 enabling or disabling, 531
element descriptions, 219 Host Connection Status flyout
Glossary tab description of, 529
Help window description, 41 element descriptions, 529
Help window illustration, 41 host connection statuses
procedure for use, operations manual, 50 descriptions of, 530
graphical symbols host interface settings
assay technology, 428 configuring, 228
guidelines host interface specifications
1D reagent bar code labels (c-series), 465 description of, 462
sample bar code labels, 469 host orders
description of, 652
H Host Setup screen
description of, 225
handling consumables element descriptions, 225
requirements, 812 hot objects
hard drive exposure to, 836
specifications, 462
hardware overview
I
Alinity ci-series, 56
hardware troubleshooting i-series
c-series, 1025 electrical specifications and requirements, 457
i-series, 1027 principles of operation, 428
hazards processing module capacities, 451
hot objects, 836 processing module characteristics, 445
mechanical, 833 processing module specifications, operational, 448
tripping, 836 ICT measurement (c-series potentiometric)
heat dissipation data reduction calculation, 413
c-series electrical specifications, 456 description of, 409
i-series electrical specifications, 457 ICT Reference Solution and sample delivery and
heavy objects processing, 409
lifting techniques, 835 measurement by the ICT module, 412
precautions, 835 ICT module (c-series)
high-concentration waste bottle (c-series) configuring processing module settings, 189
emptying bottle and updating inventory, 583 configuring the expiration, 210
HL7 communication description of, 154
configuring, 231 enabling or disabling, 1463
verifying, 1466 illustration of, 154

80000071-105 - 2018-09-10
Index
illustration of internal components, 412 initializing

location of, 90 processing module and reagent and sample
replacing, 952 manager (RSM), 500
ICT module expiration (c-series) initiating
configuring, 210 sample processing, 648
ICT probe (c-series) inserting and removing
location of, 90 USB flash drive, 764
replacing, 952 Install/Uninstall Assays screen
ICT protocol (c-series) description of, 321
assay protocol type, 422 Install/Uninstall Assays screen, Available Files tab
ICT Reference Solution delivery (c-series) element descriptions, 321
description of sequence, 409 Install/Uninstall Assays screen, Installed Files tab
ICT sample delivery (c-series) Install/Uninstall Procedures screen
description of sequence, 409 description of, 367
illustration of, 409 Install/Uninstall Procedures screen, Available Files tab
ICT unit (Alinity c) element descriptions, 368
description of, 90 Install/Uninstall Procedures screen, Installed Files tab
location of, 952 installation procedures and special requirements
Import Calibrators screen overview, 165
c-series element descriptions, 309 installing
Import screen assay files, 325
element descriptions, 348 maintenance and diagnostic procedure files, 371
Import/Export Assays screen (c-series) system, 166
description of, 328 system update, 391
Import/Export Assays screen, Export Files tab instrument statuses
c-series element descriptions, 329 descriptions of, 557
Import/Export Assays screen, Import Files tab transition of, 559
c-series element descriptions, 329 integrated chip technology (c-series potentiometric)
importing description of, 408
c-series assay files, 332 Intellectual Property statement
calibrator data, 314 description of, 27
quality control data, 361 intended use
translated version of the operations manual, 394 description of, 21
users, 178
inactivating K
users, 177
including key to symbols
Levey-Jennings points, 738 descriptions of, 28
index calibration (i-series) illustrations of, 28
description of, 792
Index tab L
Help window description, 41
Help window illustration, 41 labels
procedure for use, operations manual, 49 1D reagent bar code label guidelines (series), 465
indirect assay processing method (c-series) sample bar code label guidelines, 469
principles of operation, 423 lamp (Alinity c)
induction heater wash cup (Alinity i) description of, 86
description of, 126 illustration of, 86
illustration of, 126 lamp (c-series)
pipetting hardware, 126 replacing, 937

80000071-105 - 2018-09-10
Index
lamp plate (c-series) description of, 1472

replacing, 937 i-series precision and bias method worksheet, 1486
language i-series total allowable error method worksheet, 1482
configuring, 221 LoQ claim, precision method, 1488
LAS communication verifying an LoQ claim, precision and bias method,
configuring, 235 1483
verifying, 1467 verifying an LoQ claim, total allowable error method,
LAS Communication screen 1479
description of, 234 linear data reduction method (c-series photometric)
LAS connection linear regression data reduction method (i-series)
disabling, 536 description of, 786
enabling, 536 illustration of, 786
LAS Connection Status flyout linear transformation adjustment method (i-series)
element descriptions, 535 linearity
LAS connection statuses c-series flagging, 1581
descriptions of, 536 c-series worksheet, 1502
level sensor i-series worksheet, 1503
c-series bulk solution, replacing, 986 verifying, 1501
Concentrated Wash Buffer (i-series), replacing, 1010 linearity flagging (c-series)
i-series diluted wash buffer, replacing, 1014 description of, 1581
Pre-Trigger Solution (i-series), replacing, 1010 linear data reduction method, 1581
Trigger Solution (i-series), replacing, 1010 spline and logit-4 nonlinear data reduction methods,
Levey-Jennings (Graph) screen 1581
description of, 733 liquid waste arm
element descriptions, 733 illustration of, 111
Levey-Jennings graphs liquid waste arm probe (i-series)
creating, 747 replacing, 1005
Levey-Jennings points liquid waste container (c-series)
adding comments to, 739 configuring, 189
displaying the values for, 738 liquid wastes
excluding or including, 738 waste handling precautions, 826
viewing details for, 739 list numbers
licenses consumables, 1530
printing reports, 399 consumables (c-series), 1531
viewing reports, 399 consumables (i-series), 1532
limit of blank (LoB) description of, 1529
c-series worksheet, 1473 service accessories, 1533
description of, 1472 load statuses
i-series worksheet, 1474 descriptions of, 619
verifying an LoB claim, 1472 loading
limit of detection (LoD) bar-coded specimens for batch processing, 597
c-series worksheet, 1476 calibrator and control vials for immediate use, 646
description of, 1472 calibrator and control vials for onboard storage, 624
i-series worksheet, 1477 cartridges on reagent and sample manager (RSM),
verifying an LoD claim, 1475 599
limit of quantitation (LoQ) floor, typical, 453
assay claim definitions, 1478 onboard solutions on reagent and sample manager
c-series precision and bias method worksheet, 1485 (RSM), 604
c-series total allowable error method worksheet, onboard vial racks or cartridges on a specific
1480 processing module, 602

80000071-105 - 2018-09-10
Index
racks on reagent and sample manager (RSM), 595 Manual File Request screen, Calibrator Data tab (c-
sample diluents on reagent and sample manager series)
(RSM), 604 element descriptions, 548
samples into sample racks, 643 maximum absorbance variation (c-series photometric)
vial racks for immediate use, 646 description of, 1583
vial racks for onboard storage, 624 maximum curve fit (c-series photometric)
loading area description of, 1585
description of, 72 measuring interval
illustration of, 72 description of, 1505
locking mechanical hazards
user interface, 510 description of, 833
Log On screen menu bar
Log Report message alert
logging on message codes
system, 510 assay-specific (1000-1999), 1051
logit-4 data reduction method (c-series photometric) computer hardware peripheral (8000-8999), 1051
description of, 778 general (0001-0999), 1051
long-term shutdown (i-series) level sense and fluidics (3000-3999), 1051
description of, 505 maintenance and diagnostic (2000-2999), 1051
optics and bar code reader (4000-4999), 1051
M robotics and sensor (5000-5999), 1051
software (9000-9999), 1051
mail statuses support system (6000-6999), 1051
descriptions of, 552 temperature (7000-7999), 1051
maintenance Message Details For flyout
overview of, 838 element descriptions, 1049
maintenance and diagnostic procedure files message probable cause and corrective action
installing, 371 viewing, 1034
uninstalling, 371 message types
maintenance and diagnostic procedure statuses descriptions of, 1049
descriptions of, 856 messages
Maintenance History Report clearing, 1035
element descriptions, 1661 deleting a message from the Alert Center, 1035
maintenance log deleting all messages from the Alert Center, 1035
approving, 856 viewing associated messages, 1034
maintenance procedure method comparison
performing, 849 description of, 1511
maintenance solutions (c-series) qualitative worksheet (c-series), 1519
description of, 153 qualitative worksheet (i-series), 1522
illustration of, 153 qualitative, performing, 1518
managing quantitative worksheet (c-series), 1513
user PINs, 179 quantitative worksheet (i-series), 1516
manual backup quantitative, performing, 1511
performing, 382 minimum sample volume
Manual File Request screen requirements, 476
description of, 546 mixers (Alinity c)
Manual File Request screen, Assay Files tab description of, 87

80000071-105 - 2018-09-10
Index
mixers (c-series) O
replacing, 948
module name observed problems
configuring for c-series, 189 c-series processing module, 1418
configuring for i-series, 190 c-series sample results, 1424
Modules screen general description, 1417
c-series element descriptions, 184 i-series processing module, 1422
description of, 182 i-series sample results, 1435
i-series element descriptions, 187 printer, 1446
Modules screen, reagent and sample manager (RSM) user interface (UI) computer, 1446
element descriptions, 183 onboard calibrator and control sample processing
monitor reagent and sample manager (RSM), 641
adjusting the position, 65 onboard calibrators and controls
specifications, 462 configuring for c-series, 189
configuring for i-series, 190
onboard sample storage
N requirements, 477
name onboard solution inventory
configuring, 221 configuring low alert settings, 210
navigation pane onboard solution inventory low alert settings
Help window description, 38 configuring, 210
Help window illustration, 38 onboard solutions
network cables to the system control module (SCM) preparing, 625
reseating, 1469 onboard solutions (c-series)
network connectors Acid Probe Wash, 152
illustration of, 64 Detergent A, 152
New Cal Set flyout (c-series photometric, user defined) Detergent B, 152
New Reagent flyout (c-series photometric, user onboard storage criteria
defined) calibrator vials, 642
element descriptions, 1553 control vials, 642
new users onboard vial racks on a specific processing module
creating, 174 loading, 602
Notepad flyout One Step 25 protocol (i-series)
description of, 511 assay protocol type, 434
element descriptions, 511 one-reagent protocol (c-series)
notes assay protocol type, 417
adding comments, 516 operational precautions and limitations
creating, 514 impact of failure to comply, 809
deleting, 517 operations manual
deleting all unpinned, 517 accessing, 45
display order of comments, 516 changing the position, 50
editing, 515 closing, 50
maximum number of comments, 516 conventions for, 36
pinning, 515 Help window description, 37
unpinning, 515 Help window illustration, 37
viewing, 514 importing translated version, 394
number format organization of, 34
configuring, 221 using the, 45
operations manual content
moving through a sequence of topics, 49

80000071-105 - 2018-09-10
Index
paging through, 49 orders

operations manual glossary automated, 652
using, 50 bar-coded batch specimen, creating, 684
operations manual home page calibration, creating, 688
displaying, 45 control, creating, 686
operations manual index host, 652
using, 49 single specimen, creating, 682
operations manual navigation pane specimen, adding test to, 689
hiding, 49 Orders screen
operations manual related information description of, 659
accessing, 48 element descriptions, 660
operations manual table of contents Orders screen, Search flyout
hiding, 49 element descriptions, 661
scrolling through the, 46 overriding
operations manual terms calibration expiration, 341
searching for, 50 calibrator lot expiration, 341
operations manual topic control lot expiration, 341
printing, 51
redisplaying, 49 P
scrolling through an, 46
using breadcrumbs to access, 48 packages
operator troubleshooting, 396
responsibility for using the system, 818 panel
optical measurement (c-series photometric) configuring, 338
data reduction calculation, 407 deleting, 339
description of, 405 panel definition
optical system and measurement sequence, 405 editing, 338
optical subsystem troubleshooting Panel Definition screen
c-series, 1025 description of, 336
i-series, 1027 element descriptions, 336
optical system parameter adjustment method (i-series)
c-series illustration, 405 description of, 790
i-series illustration, 431 pausing
optics (Alinity i) processing module, 500
illustration of, 116 reagent and sample manager (RSM), 501
optics values (i-series) pending transmissions
configuring, 190 cancelling, 531
optimum sampling sequence feature (c-series) Perform Procedure screen
optional components element descriptions, 843
description of, 136 Performance characteristics and specifications
external waste pump, 136 overview, 443
induction heater wash cup (Alinity i), 126 performing
Order Details (Bar-Coded Batch Specimen) screen calibration verification, 1497
element descriptions, 666 emergency shutdown, 502
Order Details (Single Specimen, Control, and initial user-defined assay run, 1603
Calibrator) screen maintenance or diagnostic procedure, 849
element descriptions, 664 manual backup, 382
Order Details screen qualitative method comparison, 1518
description of, 664 quantitative method comparison, 1511
Order List Report reagent carryover evaluation (c-series), 1605

80000071-105 - 2018-09-10
Index
personal display theme point-to-point data reduction method (i-series)

configuring, 182 description of, 785
photometric calibration methods (c-series) illustration of, 785
description of, 774 potentiometric calibration method (c-series)
use cal factor blank, 781 description of, 769
photometric calibration types (c-series) potentiometric data reduction method (c-series)
description of, 774 electromotive force measurement, 769
photometric data reduction methods (c-series) sample measurement, 772
absorbance, 775 slope calculation, 770
factor, 775 potentiometric method (c-series)
linear, 776 ICT measurement, 409
logit-4, 778 integrated chip technology, 408
spline, 779 principles of operation, 408
photometric method (c-series) powering off
optical measurement, 405 processing module, 494
photometric technology, 402 reagent and sample manager (RSM), 499
principles of operation, 402 user interface (UI) computer, 488
photometric technology (c-series photometric) powering on
description of, 402 processing module, 489
end-point assay reactions, 403 reagent and sample manager (RSM), 497
rate assay reactions, 404 user interface (UI) computer, 488
photometric timing table (c-series photometric, user Pre-Trigger and Trigger manifold (Alinity i)
defined) illustration of, 115
description of, 1586 precautions
physical hazards description of, 821
overview, 835 precautions and requirements before operation
physical specifications description of, 811
Alinity ci-series, 452 precautions during operation
pipetting hardware (Alinity c) description of, 811
description of, 78 precision
illustration of, 78 c-series worksheet, 1493
processing center, 78 calculating a verification value, 1492
pipetting hardware (Alinity i) description of, 1489
configurations, 122 evaluating the data, 1490
description of, 122 i-series worksheet, 1495
illustration of, 122 verifying the, 1489
processing center, 122 precision and bias method
pipettor probes (i-series) verifying an LoQ claim, 1483
reagent, replacing, 998 precision method
sample, replacing, 998 LoQ claim, 1488
pipettors (Alinity c) preparing
illustration of, 79 calibrator and control vials for immediate use, 646
reagent 1, description, 79 calibrator and control vials for onboard storage, 624
reagent 2, description, 79 onboard solutions, 625
sample, description, 79 reagent cartridges, 622
pipettors (Alinity i) sample diluents and user-defined reagents, 627
illustration of, 124 vial racks for immediate use, 646
reagent 1, description, 124 vial racks for onboard storage, 624
reagent 2, description, 124 pretreatment path (Alinity i)
sample, description, 124 illustration of, 118
Point Details screen pretreatment path motor (Alinity i)

80000071-105 - 2018-09-10
Index
pretreatment protocol (c-series) Printer Verification flyout

assay protocol type, 421 element descriptions, 194
pretreatment protocol (i-series) Printers screen
assay protocol type, 437 description of, 191
pretreatment unload diverter (Alinity i) element descriptions, 191
illustration of, 119 printing
pretreatment vortexer (Alinity i) 1D reagent bar code report, 630
illustration of, 121 Abbott Mail documentation, 553
primary components assay inserts, 635
Alinity ci-series, 56 calibrator value sheet (c-series), 320
primary sample tubes Licenses Report, 399
specifications, 473 quality control inserts, 363
volumes, 476 reports, 755
principles of operation screen images, 756
c-series, 402 system update documentation, 390
i-series, 428 priority positions
principles of operation (c-series) assigning temporary positions to load racks and
assay processing, 414 cartridges, 606
indirect assay processing method, 423 priority sections
optimum sampling sequence feature, 424 configuring, 189
photometric method, 402 probe conditioning solution (i-series)
potentiometric method, 408 description of, 154
sample interference indices, 425 illustration of, 154
SmartWash feature, 423 probe tubing
principles of operation (i-series) c-series reagent, replacing, 933
assay processing, 433 c-series sample, replacing, 930
CMIA method, 428 probes
Print flyout c-series reagent, replacing, 925
description of, 751 c-series sample, replacing, 922
element descriptions, 752 i-series liquid waste arm, replacing, 1005
print job i-series reagent pipettor, replacing, 998
deleting, 533 i-series sample pipettor, replacing, 998
print jobs i-series wash zone, replacing, 1001
viewing the printer queue, 533 probes and other sharps
print screen precautions, 835
configuring, 213 procedure key
printed report element descriptions Alinity c illustration, 58
description of, 1613 Alinity i illustration, 58
printer description of, 58
adding, 195 SCM illustration, 58
changing default, 197 procedure key settings
configuring, 195 descriptions of, 845
editing, 196 procedure map
observed problems, 1446 description of, 52
removing, 198 displaying and using, 46
verifying, 197 illustration of, 52
Printer Queue flyout task lists, 53
element descriptions, 194 Procedure Report
Printer Status/Queue flyout element descriptions, 1671
description of, 532 Procedures Log screen

80000071-105 - 2018-09-10
Index
Procedures Log screen, Diagnostics tab emptying the diluted wash buffer reservoir (i-series),
Procedures Log screen, Maintenance tab enabling or disabling the ICT module (c-series),
Procedures screen manually unloading a cartridge or rack from the
description of, 838 reagent carousel, 1449
element descriptions, 839 processing module interface specifications
process path (Alinity i) description of, 462
illustration of, 107 processing module specifications, electrical
process path light cover (Alinity i) c-series, 456
configurations, 106 i-series, 457
illustration of one-piece cover, 106 processing module specifications, liquid waste output
illustration of two-piece cover, 106 c-series, 460
process path light cover (i-series) i-series, 460
illustration of configurations, 991 processing module specifications, operational
removal and replacement overview, 991 c-series, 447
process path light cover, one piece (i-series) i-series, 448
removing, 992 processing module wash (c-series)
replacing, 992 description of, 162
process path light cover, two piece (i-series) processing priorities
removing, 995 reagent and sample manager (RSM), 638
replacing, 995 proprietary statement
process path motor (Alinity i) description of, 22
illustration of, 114 pump center (Alinity c)
processing center components, 95
Alinity i description, 105 description of, 95
Alinity i illustration, 105 illustration of, 95
processing center interior lights
button illustration, 74 Q
description of, 74
processing codes QC Analysis Report
descriptions of, 691 element descriptions, 1673
processing module QC Levey-Jennings Report
Alinity c description, 76 element descriptions, 1676
Alinity i description, 102 QC Summary Report
c-series observed problems, 1418 element descriptions, 1679
general description, 74 qualitative method comparison
general observed problems, 1417 c-series worksheet, 1519
i-series observed problems, 1422 i-series worksheet, 1522
optional components, 136 performing, 1518
pausing, 500 quality control
processing center interior lights, 74 adding an assay, 357
processing module capacities deleting an assay, 358
c-series, 450 quality control (QC) summary data
i-series, 451 viewing, 749
processing module characteristics quality control analysis
c-series, 444 description of, 729
i-series, 445 quality control data
processing module corrective action procedures importing, 361
emptying the bulk solution reservoirs (c-series), 1452 quality control data, imported
emptying the bulk solution reservoirs (i-series), 1456 deleting, 363

80000071-105 - 2018-09-10
Index
quality control import statuses reaction check (c-series photometric)

descriptions of, 364 description of, 1590
quality control inserts reaction graphs for results
printing, 363 viewing, 726
viewing, 363 reaction vessels (i-series)
quality control lot description of, 155
manually creating, 349 illustration of, 155
quality control lots replenishing and updating inventory, 586
deleting, 359 reagent and sample manager
quality control result flags configuring, 189
descriptions of, 724 reagent and sample manager (RSM)
Quality Control screen capacities, 452
description of, 342 components, 70
Quality Control Summary screen illustration of, 70
description of, 740 loading area, 72
element descriptions, 740 processing priorities, 638
Quality Control Summary screen, Search flyout sample processing, 639
element descriptions, 742 sample processing for onboard calibrators and
quality controls controls, 641
deleting, 360 status indicators, 73
editing, 353 reagent and sample manager (RSM) corrective action
quantitative method comparison procedure
c-series worksheet, 1513 removing racks from the sample positioners, 1464
i-series worksheet, 1516 reagent carousel
performing, 1511 manually unloading cartridges, 1449
quiet zone manually unloading racks, 1449
1D reagent bar code labels (c-series), 465 reagent carousel (Alinity c)
sample bar code labels, 469 components, 101
description of, 101
R illustration of, 101
reagent carousel (Alinity i)
racks components, 134
illustration of, 157 description of, 134
removing from the sample positioners, 1464 illustration of, 134
unloading from the reagent carousel, 1449 reagent carousel inventory
racks and cartridges verifying, 622
loading into trays, 592 reagent carousel inventory management
racks, vial description of, 607
loading for immediate use, 646 reagent carryover evaluation (c-series photometric)
loading for onboard storage, 624 description of, 1605
preparing for immediate use, 646 reagent carryover evaluation (c-series)
preparing for onboard storage, 624 performing, 1605
rate assay reactions (c-series photometric) reagent cartridge
photometric technology, 404 disabling, 634
rate down assay reaction curve (c-series photometric) enabling, 634
illustration of, 404 Reagent Cartridge Details screen
rate linearity percent (c-series photometric) description of, 615
ratio technique adjustment methods (i-series) reagent cartridge with empty bottles (c-series)
illustration of, 158

80000071-105 - 2018-09-10
Index
reagent cartridges Reagents screen, Current tab

preparing, 622 element descriptions, 609
reagent inventory Reagents screen, Historical tab
processing, 643 element descriptions, 612
reagent inventory (individual c-series) Reagents screen, Search flyout
reagent inventory (individual i-series) reference data reduction method (i-series)
reagent kits and components reference range (expected values)
Alinity c reagent cartridge, 146 c-series worksheet, 1526
Alinity i reagent cartridge, 146 i-series worksheet, 1527
Alinity Reagent Replacement Cap, 146 verifying the, 1525
description of, 146 releasing
illustration of, 146 control results, 704
reagent troubleshooting (c-series), 1029 specimen results, 704
reagent troubleshooting (i-series), 1030 relocating
reagent lot expiration system, 167
overriding, 207 removing
reagent low alert setting (individual c-series) one-piece process path light cover (i-series), 992
configuring, 209 printer, 198
reagent low alert setting (individual i-series) racks from the sample positioners, 1464
configuring, 209 RV waste and updating inventory (i-series), 584
reagent probes (c-series) two-piece process path light cover (i-series), 995
replacing, 925 replacing
replacing the tubing, 933 1 mL syringes (c-series), 958
reagent stability Acid Probe Wash (c-series), 581
overriding, 207 bulk solution level sensor (c-series), 986
Reagent Status Report bulk solution level sensor for Concentrated Wash
element descriptions, 1681 Buffer (i-series), 1010
reagent supply center (Alinity c) bulk solution level sensor for Pre-Trigger Solution (i-
description of, 100 series), 1010
illustration of, 100 bulk solution level sensor for Trigger Solution (i-
reagent carousel, 101 series), 1010
reagent supply center (Alinity i) bulk solutions and updating inventory, 579
components, 100, 133 check valves (c-series), 961
description of, 133 cuvette dry tip (c-series), 945
illustration of, 133 cuvette segments (c-series), 941
reagent carousel, 134 Detergent A (c-series), 581
reagent syringe (c-series) diluted wash buffer level sensor (i-series), 1014
replacing the O-ring and seal tips, 972 external waste pump, 1017
reagent syringes (Alinity c) ICT module (c-series), 952
description of, 99 ICT probe (c-series), 952
illustration of, 99 lamp (c-series), 937
Reagents and Supplies screen lamp plate (c-series), 937
description of, 201 liquid waste arm probe (i-series), 1005
Reagents and Supplies screen, Reagents/Diluents tab mixers (c-series), 948
element descriptions, 202 one-piece process path light cover (i-series), 992
Reagents and Supplies screen, Supplies tab reagent pipettor probes (i-series), 998
element descriptions, 205 reagent probe tubing (c-series), 933
Reagents screen reagent probes (c-series), 925
description of, 608 reagent syringe O-ring and seal tips (c-series), 972

80000071-105 - 2018-09-10
Index
sample onboard wash solutions and updating Result List Report

inventory (c-series), 581 element descriptions, 1689
sample pipettor probe (i-series), 998 results
sample probe (c-series), 922 archiving, 761
sample probe tubing (c-series), 930 transmitting to the host, 727
sample syringe O-ring and seal tips (c-series), 979 viewing absorbance data for, 726
two-piece process path light cover (i-series), 995 viewing reaction graphs for, 726
wash solution syringe O-ring and seal tips (c-series), Results screen
965 description of, 706
wash zone probes (i-series), 1001 Results screen, Control tab
replenishing element descriptions, 710
reaction vessels and updating inventory (i-series), Results screen, Exception tab
586 element descriptions, 711
Report File Location window Results screen, Search flyout
reports Results screen, Specimen tab
printing, 755 Results screen, Unreleased tab
Reports screen element descriptions, 707
description of, 211 results, sample
element descriptions, 211 deleting, 727
Requested Categories flyout resuming
element descriptions, 549 sample processing, 648
requirements for Retest Assays flyout
handling consumables, 812 element descriptions, 286
Rerun List Report retest options
Rerun Options (Control Order) flyout retest rules
Rerun Options (Specimen Order) flyout retrieving
element descriptions, 719 troubleshooting package, 396
rerunning RV access door (Alinity i)
tests or exceptions for a specimen or control, 703 illustration of, 113
reseating RV loader system (Alinity i)
network cables to the system control module (SCM), illustration of, 127
1469 RV unloader (Alinity i)
reservoir areas (Alinity i) illustration of, 117
bulk solution reservoir area, 130 RV waste (i-series)
descriptions of, 130 removing and updating inventory, 584
illustrations of, 130 RV waste storage area (Alinity i)
pump drawer, 130 components, 132
restarting description of, 132
AbbottLink, 537 illustration of, 132
Result Details (Specimen and Control) screen
element descriptions, 715 S
Result Details Report
element descriptions, 1685 safety icons
Result Details screen description of, 819
description of, 715 sample and reagent syringe area (Alinity c)
result interpretation components, 99
limitations of, 816 description of, 99
illustration of, 99

80000071-105 - 2018-09-10
Index
sample bar code checksums sample processing for onboard calibrators and
configuring, 200 controls
sample bar code labels reagent and sample manager (RSM), 641
changing, 200 sample results
configuring, 200 c-series observed problems, 1424
guidelines, 469 deleting, 727
sample bar code length i-series observed problems, 1435
configuring, 200 Sample Status screen
sample bar code start/stop characters description of, 693
sample bar code type Sample Status screen, Search flyout
sample cups sample syringe (Alinity c)
illustration of, 156 illustration of, 99
illustrations and measurement, 473 sample syringe (c-series)
volumes, 476 replacing the O-ring and seal tips, 979
Sample Details (Specimen, Control, and Calibrator) sample tube specifications (aliquot and primary)
screen illustration and measurements, 473
element descriptions, 698 sample volume requirements
Sample Details screen aliquot tube, 476
sample diluents and user-defined reagents primary tube, 476
preparing, 627 sample cup, 476
sample dilution (c-series photometric) samples
description of, 1592 loading into sample racks, 643
sample gauge samples that have tests in process
verifying sample volume in aliquot sample tubes, 643 accessing, 649
sample interference indices (c-series) suspending, 649
illustration of absorption spectra, 425 SCM hardware components
measurement, 425 bar code scanner, 63
protocol, 425 Ethernet switch, 63
Sample Laboratory Report firewall, 63
sample management network connectors, 63
description of, 636 RSM embedded computer, 63
sample measurement data reduction (c-series RSM X motor, 63
potentiometric) SCM power supply, 63
description of, 772 UI computer, 63
sample onboard wash solutions (c-series) UI power strip, 63
replacing and updating inventory, 581 uninterrupted power supply (UPS), 63
sample probe (c-series) waste manifold, 63
replacing, 922 water inlet, 63
replacing the tubing, 930 screen elements
sample processing descriptions of, 140
calibration, 638 screen images
control, 637 printing, 756
description of, 636 screen time-out
disabling, 221 configuring, 221
initiating or resuming, 648 Search flyout
reagent and sample manager (RSM), 639 description of, 757

80000071-105 - 2018-09-10
Index
Search tab software data storage

Help window description, 42 capacities, 449
Help window illustration, 42 software troubleshooting
procedure for use, operations manual, 50 c-series, 1025
Select Items window i-series, 1027
c-series element descriptions, 331 solutions
self blank (c-series photometric) used in daily operations (c-series), 577
description of, 1595 used in daily operations (i-series), 578
sensitizers speaker volume
precautions, 825 configuring, 221
service accessory list numbers specifications
additional accessories (i-series), 1537 electrical (c-series), 456
additional components (c-series), 1534 electrical (i-series), 457
Alinity c accessory kit #1, 1534 host interface, 462
Alinity c accessory kit #2, 1534 operator interface, 462
Alinity i accessory kit, 1537 physical, 452
customer maintenance kit (c-series), 1534 processing module interface, 462
description of, 1533 specifications, external waste pump
Set PIN flyout clearances, 464
element descriptions, 177 dimensions, 464
Set Stability flyout electrical, 464
element descriptions, 347 weight, 464
setting specifications, liquid waste output
declined system update as available for installation, c-series, 460
393 i-series, 460
settings specifications, operational
procedure key, 845 c-series, 447
shortcut icons i-series, 448
configuring, 237 specifications, optical
Shortcuts c-series, 458
element descriptions, 236 specifications, SCM
Shortcuts screen hard drive, 462
description of, 236 monitor, 462
Show Picture flyout specimen collection
element descriptions, 845 requirements, 814
Show Video flyout specimen handling
element descriptions, 844 requirements, 814
slope calculation data reduction (c-series specimen preparation and storage
potentiometric) requirements, 814
description of, 770 specimen result flags
SmartWash (c-series) descriptions of, 722
configuring settings, 1608 specimen results
editing settings, 1610 releasing, 704
verifying settings, 1608 spills
SmartWash feature (c-series) cleanup precautions, 828
principles of operation, 423 spline data reduction method (c-series photometric)
sodium azide description of, 779
precautions, 824 stability
sodium hydroxide solution sodium hypochlorite, 830
preparing, 829 starting
sodium hypochlorite processing module and reagent and sample
stability, 830 manager (RSM), 500

80000071-105 - 2018-09-10
Index
STAT for One Step 11 protocol (i-series) Supplies screen, Supply Details flyouts for Acid Probe
assay protocol type, 439 Wash and Detergent A (c-series)
STAT for Two Step 4-4 protocol (i-series) element descriptions, 570
assay protocol type, 440 Supplies screen, Supply Details flyouts for Alkaline
STAT protocol (i-series) Wash, Acid Wash, and ICT Reference (c-series)
status indicators Supplies screen, Supply Details flyouts for Pre-Trigger,
description of, 73 Trigger, and Wash Buffer
statuses supply and pump center (Alinity c)
assay file reagent, 325 bulk solution reservoir area, 98
assay file request, 549 bulk solution storage area, 97
assay insert, 621 components, 94
calibration, 804 description of, 94
calibrator import (c-series), 317 illustration of, 94
cartridge, 617 pump center, 95
file update, 324 sample and reagent syringe area, 99
host connection, 530 supply and waste inventory
instrument, 557 verifying, 579
LAS connection, 536 supply center (Alinity i)
load, 619 bulk solution storage area, 129
mail, 552 components, 128
maintenance and diagnostic procedures, 856 description of, 128
quality control import, 364 illustration of, 128
test, 691 reservoir areas, 130
transmission, 725 RV waste storage area, 132
vial, 590 supply low alerts
view, 552 configuring, 210
stopping supply options
processing module and reagent and sample overriding lot expiration, 210
manager (RSM), 502 overriding stability, 210
storage suspending
description of requirements, 812 samples that have tests in process, 649
storage requirements symbology
description of, 812 1D reagent bar code labels (c-series), 465
Supplies screen sample bar code labels, 469
c-series element descriptions, 562 symbols
description of, 561 key to, 28
i-series element descriptions, 571 syringe area (Alinity c)
Supplies screen, Supply Details flyout for ICT Module sample and reagent, 99
(c-series) syringes (c-series)
element descriptions, 569 1 mL, replacing, 958
Supplies screen, Supply Details flyout for Liquid Waste O-ring and seal tips for reagent, replacing, 972
(c-series) O-ring and seal tips for sample, replacing, 979
element descriptions, 570 O-ring and seal tips for wash solution, replacing, 965
Supplies screen, Supply Details flyout for RV Waste (i- reagent, description of, 99
series) reagent, illustration of, 99
element descriptions, 576 sample, description of, 99
Supplies screen, Supply Details flyout for RVs sample, illustration of, 99
element descriptions, 575 system
checking for appropriate operation, 166
clearances, 455

80000071-105 - 2018-09-10
Index
configuring, 168 System Logs screen, User Access tab

installing, 166 element descriptions, 1040
logging on, 510 system operation precautions and requirements
relocating, 167 impact of failure to comply, 811
system characteristics system prime (i-series)
Alinity ci-series, 444 description of, 162
system control module (SCM) system security
computer and interface specifications, 462 Alinity systems, 19
distance alert, 68 responsibility for, 19
electrical specifications and requirements, 456 system update
hardware components, 63 adding comments, 393
illustration of, 60 declining, 392
network connectors, 64 downloading software, 391
procedure key, 58 installing, 391
processor specifications, 462 printing documentation, 390
reseating network cables, 1469 setting a declined update as available for
software data storage capacities, 449 installation, 393
system documentation verifying manually, 392
description of, 33 viewing documentation, 390
system flush (c-series) System Update Details Report
system flush (i-series) System Update Import screen
system installation and relocation System Update List Report
overview, 166 element descriptions, 1696
system level control sample processing System Updates screen
system level reagent inventory element descriptions, 384
configuring, 207
system level reagent low alert setting T
configuring, 207
System Logs screen temperature
description of, 1036 c-series, 447
Message Details For flyout element descriptions, environmental requirements, 461
1049 i-series, 448
System Logs screen, Abbott Mail tab test statuses
element descriptions, 1043 descriptions of, 691
System Logs screen, All Messages tab tests from sample orders
element descriptions, 1044 deleting, 692
System Logs screen, Configuration tab tests or exceptions for a specimen or control
element descriptions, 1041 rerunning, 703
System Logs screen, Informational tab time
System Logs screen, Interfaces tab toolbar
element descriptions, 1042 Help window description, 38
System Logs screen, Inventory tab Help window illustration, 38
element descriptions, 1039 topic pane
System Logs screen, Notifications/Alerts tab Help window description, 43
element descriptions, 1036 Help window illustration, 43
System Logs screen, Search flyout total allowable error method
element descriptions, 1046 verifying an LoQ claim, 1479

80000071-105 - 2018-09-10
Index
transmission statuses U
descriptions of, 725
transmitting uninstalling
calibrations to the host, 806 assay files, 327
exceptions to the host, 727 maintenance and diagnostic procedure files, 371
results to the host, 727 user-defined maintenance procedures, 377
trays unloading
illustration of, 158 cartridges from the reagent carousel, 1449
loading on reagent and sample manager (RSM), 594 racks and cartridges from reagent carousel to RSM,
tripping hazards 631
description of, 836 racks from the reagent carousel, 1449
troubleshooting reagents from reagent and sample manager (RSM),
Alert Center flyout element descriptions, 1033 633
approach to, 1024 samples from reagent and sample manager (RSM),
troubleshooting package 650
retrieving, 396 trays from reagent and sample manager (RSM), 607
troubleshooting packages vials from reagent and sample manager (RSM), 650
descriptions of, 396 unscheduled cleaning
troubleshooting reagent variables (c-series) cleaning and decontaminating external components,
calibrators, 1029 873
controls, 1029 cleaning and decontaminating the bar code scanner,
description of, 1029 874
reagent kits, 1029 cleaning and decontaminating the monitor, 874
troubleshooting reagent variables (i-series) description of, 873
calibrators, 1030 USB flash drive
controls, 1030 copying a backup, 383
description of, 1030 inserting and removing, 764
reagent cartridges, 1030 use cal factor blank calibration method (c-series
Troubleshooting screen photometric)
element descriptions, 395 user interface
troubleshooting system variables (c-series) description of, 139
consumables, 1025 illustration of, 139
description of, 1025 locking, 510
fluidics subsystems, 1025 user interface (UI) computer
hardware, 1025 observed problems, 1446
optical subsystem, 1025 powering off, 488
software, 1025 powering on, 488
troubleshooting system variables (i-series) user interface (UI) computer corrective action
consumables, 1027 procedures
description of, 1027 verifying the ASTM communication, 1468
fluidics subsystems, 1027 verifying the HL7 communication, 1466
hardware, 1027 verifying the LAS communication, 1467
optical subsystem, 1027 user PINs
software, 1027 changing, 182
Two Step 18-4 protocol (i-series) managing, 179
assay protocol type, 435 User Profile screen
two-reagent protocol (c-series) description of, 180
assay protocol type, 419 element descriptions, 180
types user-defined assay run, initial
message, 1049 performing, 1603

80000071-105 - 2018-09-10
Index
user-defined assays (c-series photometric) supply and waste inventory, 579

creating, 1598 vial inventory data, 591
User-Defined Maintenance Details Report verifying manually
element descriptions, 1698 system update, 392
user-defined maintenance procedures Version Details for Procedure flyout
creating, 375 element descriptions, 841
editing, 376 vial inventory data
exporting, 378 verifying, 591
uninstalling, 377 vial racks
User-Defined Maintenance screen loading for immediate use, 646
description of, 372 loading for onboard storage, 624
User-Defined Maintenance screen, Create/Edit tab preparing for immediate use, 646
screen preparing for onboard storage, 624
element descriptions, 372 vial statuses
User-Defined Maintenance screen, Export tab descriptions of, 590
element descriptions, 374 vials, calibrator
users loading for immediate use, 646
activating, 177 loading for onboard storage, 624
editing, 176 onboard storage criteria, 642
exporting, 179 preparing for immediate use, 646
importing, 178 preparing for onboard storage, 624
inactivating, 177 vials, control
Users Export screen loading for immediate use, 646
element descriptions, 171 loading for onboard storage, 624
Users Import screen onboard storage criteria, 642
element descriptions, 171 preparing for immediate use, 646
Users screen preparing for onboard storage, 624
description of, 169 view statuses
element descriptions, 170 descriptions of, 552
Utilities screen View/Edit Reagent flyout (c-series photometric, user
description of, 379 defined)
V viewing
Abbott Mail documentation, 553
verification Abbott Mail items, 552
assay claims, 1471 absorbance data for results, 726
verifying assay calibration status, 805
ASTM communication, 1468 assay inserts, 635
automated dilution, 1506 calibrator lot data, 310
distance alert function, 249 calibrator value sheet (c-series), 320
HL7 communication, 1466 control summary details, 750
LAS communication, 1467 details for Levey-Jennings points, 739
linearity, 1501 Licenses Report, 399
LoB claim, 1472 notes, 514
LoD claim, 1475 print jobs in the printer queue, 533
LoQ claim, precision and bias method, 1483 quality control (QC) summary data, 749
LoQ claim, total allowable error method, 1479 quality control inserts, 363
precision, 1489 reaction graphs for results, 726
printer, 197 system update documentation, 390
reagent carousel inventory, 622 vortexers (Alinity i)
reference range (expected values), 1525 illustration of, 109
SmartWash settings (c-series), 1608

80000071-105 - 2018-09-10
Index
W element descriptions, 365

What's new
warranty Alinity ci-series software changes, 14
description of, 25 Alinity ci-series software features, 14
wash cups (Alinity c) worksheets
illustration of, 81 c-series automated dilution verification, 1507
laboratory automation system, 81 c-series calibration verification, 1498
reagent 1 pipettor, 81 c-series limit of blank (LoB), 1473
reagent 2 pipettor, 81 c-series limit of detection (LoD), 1476
sample, 81 c-series limit of quantitation (LoQ), precision and
whole blood, 81 bias method, 1485
wash cups (Alinity i) c-series limit of quantitation (LoQ), total allowable
illustration of, 125 error method, 1480
reagent 1, 125 c-series linearity, 1502
reagent 2, 125 c-series precision, 1493
sample, 125 c-series qualitative method comparison, 1519
wash solution syringe (c-series) c-series quantitative method comparison, 1513
replacing the O-ring and seal tips, 965 c-series reference range (expected values), 1526
wash zone assemblies (Alinity i) i-series automated dilution verification, 1508
description of, 112 i-series calibration verification, 1499
illustration of, 112 i-series limit of blank (LoB), 1474
wash zone probes (i-series) i-series limit of detection (LoD), 1477
replacing, 1001 i-series limit of quantitation (LoQ), precision and bias
waste handling and disposal method, 1486
overview, 826 i-series limit of quantitation (LoQ), total allowable
water and liquid waste requirements error method, 1482
Alinity ci-series, 459 i-series linearity, 1503
c-series, 460 i-series precision, 1495
i-series, 460 i-series qualitative method comparison, 1522
Westgard rules i-series quantitative method comparison, 1516
application, 729 i-series reference range (expected values), 1527
configuring, 366 workstation configuration
descriptions, 730 Alinity ci-series, 56
run descriptions, 732
Westgard screen
description of, 365

80000071-105 - 2018-09-10

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Alinity ci‑series Operations

Alinity ci‑series Operations Manual 3

Menu bar..................................................................................................................... 144

4 Alinity ci‑series Operations Manual

SmartWash feature (c‑series)....................................................................................423

Alinity ci‑series Operations Manual 5

Notepad flyout element descriptions......................................................................... 511

6 Alinity ci‑series Operations Manual

Rerun Options (Control Order) flyout element descriptions.....................................720

Alinity ci‑series Operations Manual 7

Requirements for handling the consumables.......................................................................812

8 Alinity ci‑series Operations Manual

System troubleshooting variables (c‑series)...........................................................1025

Alinity ci‑series Operations Manual 9

Verification of assay claims................................................................. 1471

10 Alinity ci‑series Operations Manual

Assay Parameters screen, Calibration tab element descriptions (c‑series

Alinity ci‑series Operations Manual 11

Rerun List Report element descriptions..............................................................................1683

12 Alinity ci‑series Operations Manual

Alinity ci‑series Operations Manual 13

Improved search functionality in the Alinity ci‑series Operations Manual

Pre-Trigger Solution stability

14 Alinity ci‑series Operations Manual

Alinity c‑series reagent cartridges with empty bottles

See the following updated topics:

Water and liquid waste specifications and requirements

New printer drivers

Blank calibrator set name

Alinity ci‑series Operations Manual 15

• Automated calibration ordering, page 656

Displayed and printed calibrator concentration values

16 Alinity ci‑series Operations Manual

The following new diagnostic procedures were added:

Alinity ci‑series Operations Manual 17

General safety information

18 Alinity ci‑series Operations Manual

Alinity ci‑series Operations Manual 19

20 Alinity ci‑series Operations Manual

Alinity ci‑series Operations Manual 21

22 Alinity ci‑series Operations Manual

Data Usage Statement for AbbottLink

Alinity ci‑series Operations Manual 23

24 Alinity ci‑series Operations Manual

Alinity ci‑series warranty statement for USA

Alinity ci‑series Operations Manual 25

Alinity ci‑series agency approvals

Legal Manufacturer Abbott GmbH & Co. KG

26 Alinity ci‑series Operations Manual

Intellectual Property statement

Alinity ci‑series Operations Manual 27

Caution: Hot surface

Caution: Possibility of electric shock

ISO 3287, ISO 3767-1, ISO 7296-1/Amd 1, ISO 11192

28 Alinity ci‑series Operations Manual

Use by/Expiration date

Authorized Representative in the European

Catalog number/List number