Operator's Guide - Dimention

Rev.
02, 2019-03
Dimension EXL with LM/EXL 200 System Operator’s Guide
©2010–2019 Siemens Healthcare Diagnostics

All rights reserved.
The Dimension® Customer Information Library, Dimension® software, and reports produced by the
Dimension® software have been provided pursuant to the following agreement containing
restrictions on their use. They are also protected by federal regulations and cannot be copied,
distributed, transmitted, transcribed, or translated into any human or computer language in any form
or by any means, to any third parties, without the express written consent of
Siemens Healthcare Diagnostics, Newark, DE, 19714.
Siemens has validated the provided instructions, reagents, instrument, software and customizable
features for this system to optimize product performance and meet product specifications.
User-defined modifications are not supported by Siemens as they may affect the performance of the
system and assay results. It is the responsibility of the user to validate modifications to these
instructions, instruments, reagents or software provided by Siemens.
The material in this manual is believed adequate for the intended use of the Dimension® EXL ™
integrated chemistry system. If the system or its individual components are used for purposes other
than those specified herein, confirmation of their validity and suitability must be obtained; otherwise,
Siemens does not guarantee results and assumes no obligation or liability. Siemens warrants that the
material itself does not infringe any United States patents. No further warranty is expressed or
implied.
Dimension, EasyLink, Emit, EXL, Flex, LOCI, and QuikLYTE are trademarks of Siemens Healthcare
Diagnostics.
Intralipid ™ is a trademark of Fresenias Kabi Clayton LP.
Krytox® and Surlyn® are registered trademarks of E. I. duPont de Nemours and Company,
Wilmington, DE 19880.
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Dimension® EXL ™ System Operator’s Guide
System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Using this Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
For Additional Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
How this Guide is Organized . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Overview of the Dimension EXL System . . . . . . . . . . . . . . . . . 1-5
Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Major Components of the Dimension EXL System . . . . . . . . . . . . . . . . 1-8
Major Components of the IMT Area . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Major Components of the HM Area . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Major Components of the Reagent Area . . . . . . . . . . . . . . . . . . . . . . . . 1-11
Major Components of the Thermal Chamber Area . . . . . . . . . . . . . . . . 1-12
Major Components of the Printer Area . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
Major Components of the LOCI Module . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Software Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Using the Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Test Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Action Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
Function Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
Keypad Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
Cursor Movement Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
Keyboard Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
Help Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
Keystroke Combinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
Operating Passwords . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20
Using the Touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-21
Instrument Status Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-21
Operating Conditions Status Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24
Reagent Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-25
Cuvette Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26
UPS (Uninterruptible Power Source) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27
Vessel Feeder Empty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27
Cuvette Film Cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27
Reagent Manager . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-28
Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-28
Short Sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-28
Check Needs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-29
Alarm Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-29
Clot Check Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-29
Error Message Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-30
Applications Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-30
Message Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-30
Function Keys Area . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-30
Alert Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-31
Additional Touchscreen Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-31
System Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Daily Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Cleaning the Sample Area and Emptying Cuvette Waste . . . . . . . . . . . 2-2
Daily Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Performing a System Check Using ABS . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
1
Performing a System Check Using CHK . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Recording Manual Daily Maintenance Results . . . . . . . . . . . . . . . . . . . . 2-3
Using the Daily Maintenance Log Screens . . . . . . . . . . . . . . . . . . . . . . . 2-5
CHK Flex Reagent Cartridge Information . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Understanding the System Counters Screens . . . . . . . . . . . . . . . . . . . . 2-7
Dimension EXL System Counters Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Using the Instrument Log Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
HM System Counters Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Managing Offboard Reagent Lots . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8
Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
System Needs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Responding to System Needs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-9
Understanding System Needs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Supplies Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Review Reagent Cartridge Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
Reagent Cartridge Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
Adding Reagent Cartridges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
Manually entering a Reagent Cartridge Barcode . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15
Removing Reagent Cartridges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16
Using Third Lots of Reagent Cartridges . . . . . . . . . . . . . . . . . . . . . . . . . 2-17
Replacing HM Consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18
Replacing HM Fluids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-18
Adding/Discarding Reaction Vessels . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-20
Adding Reaction Vessels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-20
Discarding Reaction Vessels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21
Replacing IMT Consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22
Using the IMT Consumables Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-22
Replacing IMT Fluids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-23
Replacing the QuikLYTE Integrated Multisensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24
Running a Dilution Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25
Resolving a Failed Dilution Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-26
Using the IMT Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-28
Sample Container Information . . . . . . . . . . . . . . . . . . . . . . . . . 2-29
Types of Containers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-29
Types of Segments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-29
Using Sample Cups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-29
Using Primary Sample Tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-31
Using Small Sample Containers (SSC) . . . . . . . . . . . . . . . . . . . . . . . . . . 2-32
Processing Serum or Plasma Samples from SSCs: . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-33
Processing Whole Blood Samples From SSCs: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-33
Using Pediatric Tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-34
Preparing Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-35
Sample Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-35
Placing Barcode Labels on Sample Tubes . . . . . . . . . . . . . . . . . . . . . . . 2-35
Checking for Adequate Sample Volume for Processing . . . . . . . . . . . . 2-35
Enter Sample Data Screen Fields . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-38
Entering and Running Batch Samples . . . . . . . . . . . . . . . . . . . 2-40
Loading Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-41
Samples Without Barcode Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-41
Samples With Barcode Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-42
Processing Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-43
Processing Samples from Standby Status . . . . . . . . . . . . . . . . . . . . . . . 2-43
Adding Samples While the System is in Processing Status . . . . . . . . . . 2-43
Processing Samples Downloaded from an LIS . . . . . . . . . . . . . . . . . . . . 2-44
Configuring the System to Process Downloaded
Samples from an LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-44
2
Processing Non-Barcoded Samples Downloaded from an LIS . . . . . . . . . . . . . . . . . 2-45

Determining the Status of Samples . . . . . . . . . . . . . . . . . . . . . 2-46
Viewing Sample Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-46
Sample Status Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-46
Sample Status Completion Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-47
STAT Status Alert Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-48
Sample Alert Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-49
Segment Status – On Board Segments . . . . . . . . . . . . . . . . . . . . . . . . . 2-50
Segment Status – All Segments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-50
Viewing Segment Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-50
Reaction Vessel Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-52
Sample Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Understanding Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Reporting Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Test Results with Test Report Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Test Results with Reference Range Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
HIL Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Clot Check . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Printed Test Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Displaying Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Reprinting Results from the Test Results Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Searching for a Sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
Search Examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
Editing and Rerunning a Sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Rerunning Assays Using Load Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
Rerunning Assays Using Edit Sample (Clot Check Errors) . . . . . . . . . . . 3-11
Priority of Load List Screen Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
Sample Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
Resolving a Short Sample Detected . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
Short Sample - Primary Tube with a Barcode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
Short Sample – Primary Tube without a Barcode . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
Short Sample – SSC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
Short Sample – Sample Cup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
Test Report Messages and Reference Range Indicators . . . . . . 3-16
Assay Results with Test Report Messages . . . . . . . . . . . . . . . . . . . . . . . 3-16
Assay Results with Reference Range Indicators . . . . . . . . . . . . . . . . . . 3-16
Understanding Test Report Messages . . . . . . . . . . . . . . . . . . . 3-17
Abnormal Assay (abnl assay) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
Abnormal Reaction (abnl reaction) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
Aborted Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
Absorbance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
Above Assay Range (above asy rng) . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
Antigen Excess (antign excess) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
Arithmetic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
Assay Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
Assay Range Diluted (assy rng/dilu) . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
Below Assay Range (below asy rng) . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
Calibration Expired (calib’n exp’d) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-21
Clot Check Err . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22
Diluted . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22
Hemoglobin (TBI and DBI) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22
HI . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23
High ‘A’ Error (hig ‘A’ err) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23
3
HIL Interf . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23

hp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24
LO . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24
Low ‘A’ error (Low ‘A’ err) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24
lp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24
Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-24
No Reagent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25
Not Calibrated (no calib’n) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25
Process Error . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25
Substrate Depletion (subst dplet’n) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25
Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-26
Dilution Examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-27
Dilution of a Sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-27
Mixture of a Sample and a Known Standard . . . . . . . . . . . . . . . . . . . . . 3-27
50% Recovery of a Known Standard Using a Sample . . . . . . . . . . . . . . . . . . . . . . . . 3-28
Test Report Message Priorities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-29
Calibration and
Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Calibration and Verification Overview . . . . . . . . . . . . . . . . . . . 4-2
Calibrating the IMT System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Calibrating Urine Drugs of Abuse Assays . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Calibrating HA1C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Calibrating HB1C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
When to Calibrate or Verify Photometric and LOCI Assays . . . . . . . . . . 4-3
Calibration Alert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Group Calibration Alerts and Run Calibration Group . . . . . . . . 4-5
Calibrating Photometric and LOCI Assays . . . . . . . . . . . . . . . . 4-6
Setting Up and Running a Manual Calibration . . . . . . . . . . . . . . . . . . . . 4-6
Reviewing and Accepting Calibration Results . . . . . . . . . . . . . . . . . . . . 4-7
Cancelling a Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Viewing Calibration History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Restore Calibrations screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Restoring a Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Calibration Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Troubleshooting Precision of Calibration Results . . . . . . . . . . . . . . . . . 4-11
Troubleshooting Calibration Statistics . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
Troubleshooting Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12
Verifying Photometric Assays . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Setting Up and Running a Verification . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Reviewing and Accepting Verification Results . . . . . . . . . . . . . . . . . . . . 4-14
Cancelling a Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
Verification Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
Troubleshooting Precision of Verification Results . . . . . . . . . . . . . . . . . 4-16
Troubleshooting Verification Statistics . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
Troubleshooting Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17
Calibrating the IMT System . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18
Electrolyte Coefficients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18
Using Calibration Status Lists . . . . . . . . . . . . . . . . . . . . . . . . . 4-19
Create a List of Methods for Calibration . . . . . . . . . . . . . . . . . . . . . . . . 4-19
Deleting a Selected Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19
Create a Reminder List for Expiring Calibrations . . . . . . . . . . . . . . . . . . 4-20
4
Remove Calibrations from Instrument Memory . . . . . . . . . . . . . . . . . . 4-20

Calibration (or Verification) Setup Flow Chart . . . . . . . . . . . . . 4-21
Calibration (or Verification) Review Flow Chart . . . . . . . . . . . . 4-22
Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23
Quality Control Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23
Daily QC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-23
QC Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24
New Reagent and Control Lots . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24
Quality Control Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24
Processing QC Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24
Crossover QC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24
QC for Urine Drugs of Abuse Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25
Using the QC Alert Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-26
Entering QC Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-27
Setting a QC Expiration Period and Checking QC Status . . . . . . . . . . . . 4-27
Setting a QC Expiration Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-27
Setting the Same Expiration Period for All Methods . . . . . . . . . . . . . . . . . . . . . . . . 4-27
Checking QC Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-28
Defining QC Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-28
Editing QC Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-29
Defining QC Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-29
Using Previously Defined QC Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30
Editing QC Panels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-30
Grouping QC Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-31
Method Review of QC and Patient Results . . . . . . . . . . . . . . . . 4-32
Results Listing View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-33
Histogram Plot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34
Levey-Jennings Plot Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-35
Method Review Screen — Fields . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-37
Method Review Screen — Function Keys . . . . . . . . . . . . . . . . . . . . . . . 4-39
Rules Field Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-40
Reviewing QC Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-42
Deleting a Result Using the Results Listing Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 4-42
Deleting a Result Using the L-J Plot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-42
Connection Between the QC Results Listing Screen and QC L-J Plot View . . . . . . . . 4-42
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
General Instrument Care and Cleaning . . . . . . . . . . . . . . . . . . 5-2
Undiluted Bleach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Bleach Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Sodium Hydroxide Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Opening the Reagent Lid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Opening the LOCI Access Lid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Removing the HM Incubation Wheel Cover . . . . . . . . . . . . . . . . . . . . . 5-4
Weekly Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Cleaning HM Wash Probes and the R2 Reagent Probe . . . . . . . . . . . . . 5-5
Cleaning the R2 Reagent Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Monthly Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
Cleaning the Clot Check Drain on the IMT Port . . . . . . . . . . . . . . . . . . . 5-8
Replacing IMT Pump Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
Cleaning the IMT System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
Replacing Instrument Air Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12
Styletting HM Wash Probes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-14
Replacing the HM Pump Heads on Wash Station . . . . . . . . . . . . . . . . . 5-17
5
Cleaning the R1, R2 & R3 Drains . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19

Other Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21
Accessory Spare Parts Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21
Lowering and Raising the Thermal Chamber . . . . . . . . . . . . . . . . . . . . . 5-21
Lowering the Thermal Chamber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21
Raising the Thermal Chamber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-22
Calibrating Cuvette System Temperature . . . . . . . . . . . . . . . . . . . . . . . 5-23
Calibrating Reagent System Temperature . . . . . . . . . . . . . . . . . . . . . . . 5-25
Calibrating HM Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-27
Cleaning Cuvette Windows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-28
Cleaning All Windows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-29
Cleaning Bad Windows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-30
Removing and Installing Cuvette Windows . . . . . . . . . . . . . . . . . . . . . .5-32
Removing Cuvette Windows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-32
Installing Cuvette Windows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-33
Cleaning the IMT Waste Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34
Cleaning the Sample Probe and Drain . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35
Cleaning the Water Bottle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37
Replacing the Cuvette Formation Spring, Tip, and E-Clip . . . . . . . . . . . 5-45
Replacing the Cuvette Ring Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-49
Replacing the Flex Loader Home Sensor . . . . . . . . . . . . . . . . . . . . . . . . 5-50
Replacing the Flex Presence Sensor Board . . . . . . . . . . . . . . . . . . . . . . . 5-51
Replacing Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-52
Replacing AC Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-52
Replacing DC Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-53
Replacing the Heat Torch Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-54
Replacing the HM Incubate Wheel or Wash Wheel Home Sensor . . . . . 5-58
Replacing the Probe Cleaner Pump Head . . . . . . . . . . . . . . . . . . . . . . . . 5-61
Replacing the HM Pump and Motor Assembly . . . . . . . . . . . . . . . . . . . . 5-62
Replacing an HM Wash Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-66
Replacing the HM Wash Probe Home Sensor . . . . . . . . . . . . . . . . . . . . . 5-68
Replacing HM Wash Probe Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-71
Replacing the HM Wash Wheel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-72
Replacing IMT QuikLYTE Multisensor Tubing . . . . . . . . . . . . . . . . . . . . . 5-73
IMT Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-75
Replacing the IMT Rotary Valve Seal . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-77
Replacing the IMT Rotary Valve Tubing . . . . . . . . . . . . . . . . . . . . . . . . . 5-80
Replacing the LOCI Insert . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-82
Replacing the LOCI Vacuum Cup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-83
Replacing the Photometer Filter Wheel Dual Sensor . . . . . . . . . . . . . . . 5-84
Replacing the Photometer Home Sensor . . . . . . . . . . . . . . . . . . . . . . . . 5-86
Replacing Printer Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-88
Replacing a Pump Optical Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-88
Replacing a Pump Solenoid Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-93
Replacing a Pump Syringe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-96
Replacing a Reagent Arm Radial Home Sensor . . . . . . . . . . . . . . . . . . . 5-101
Replacing a Reagent Arm Vertical Home Sensor . . . . . . . . . . . . . . . . . . 5-102
Replacing the R2 Reagent Arm Angular Home Sensor . . . . . . . . . . . . . 5-104
Replacing a Reagent Probe Tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-106
Replacing the Reagent Tray Home Sensor . . . . . . . . . . . . . . . . . . . . . . . 5-110
Replacing Reagent Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-114
Replacing the Sample Probe Tip . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-120
Replacing Sample Tubing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-124
Replacing the Source Lamp . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-127
Photometer Lamp Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-128
6
Replacing the U-Seal Element . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-129

Replacing the Vacuum Pump Muffler Filter . . . . . . . . . . . . . . . . . . . . . 5-134
Replacing the Water Bottle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-135
Re-seating a Control Board in the Card Cage . . . . . . . . . . . . . . . . . . . . 5-136
Running a System Check Using ABS . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-137
Running a System Check Using CHK . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-138
Decontamination Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-139
Alignments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
General Alignment Information . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Alignment Offsets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Printing and Viewing Alignment Offsets . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Barcode Scanner Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Cuvette Ring Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
HM Module Alignments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Aligning the Incubate Wheel to the Transfer Opening . . . . . . . . . . . . . 6-7
Aligning the Wash Wheel to the Incubate Wheel . . . . . . . . . . . . . . . . . 6-8
Aligning the Wash Probes to the Wash Wheel . . . . . . . . . . . . . . . . . . . 6-9
Aligning the Vessel Transfer Shuttle to the
Incubate Wheel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
Aligning the Vessel Transfer Shuttle to the Wash Wheel . . . . . . . . . . . 6-11
Aligning the Vessel Transfer Shuttle to Load . . . . . . . . . . . . . . . . . . . . 6-12
LOCI Arm Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15
LOCI Arm to Vessel Alignments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15
LOCI Arm to Detector Alignments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16
Photometer Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17
R1 Reagent Probe Alignments . . . . . . . . . . . . . . . . . . . . . . . . . 6-18
R1 Reagent Arm to Drain Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18
R1 Reagent Arm to Target (Cuvette) Alignment . . . . . . . . . . . . . . . . . . 6-19
R1 Reagent Arm to Reagent Tray Alignment . . . . . . . . . . . . . . . . . . . . . 6-21
R2 Reagent Probe Alignments . . . . . . . . . . . . . . . . . . . . . . . . . 6-22
R2 Reagent Arm to Drain Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-22
If a Coarse Adjustment (R2 Home Flag) is Needed . . . . . . . . . . . . . . . . . . . . . . . . . . 6-23
R2 Reagent Arm to Target (Cuvette) Alignment . . . . . . . . . . . . . . . . . . 6-24
R2 Reagent Arm to Reagent Tray Alignment . . . . . . . . . . . . . . . . . . . . . 6-25
R2 Reagent Arm to HM Incubate Wheel Alignment . . . . . . . . . . . . . . . 6-26
Reagent Tray Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-27
Sample Probe Alignments . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-29
Sample Probe to Cuvette Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-30
Sample Probe to Cup Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-31
Sample Probe to Drain Alignment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33
Sample Probe to the HM Incubate Wheel Alignment . . . . . . . . . . . . . . 6-33
Sample Probe to the IMT Port Alignment . . . . . . . . . . . . . . . . . . . . . . . 6-35
Sample Probe Maximum Depth Alignment . . . . . . . . . . . . . . . . . . . . . . 6-36
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Troubleshooting Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Help Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Specifying the Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Solving the Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
7
Customer Care Center - Technical Solutions . . . . . . . . . . . . . . . . . . . . . 7-3

Remote Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
Remote Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
Chemistry Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
When to Troubleshoot Chemistry Problems . . . . . . . . . . . . . . . . . . . . . 7-5
How to Troubleshoot Chemistry Problems . . . . . . . . . . . . . . . . . . . . . . 7-5
One or more QC results are out of range . . . . . . . . . . . . . . . . . . . . . . . . 7-6
Inaccuracy—Result Obtained is Inconsistent With Patient History . . . . 7-6
Imprecision—Test Results are Not Reproducible . . . . . . . . . . . . . . . . . . 7-7
Printing Filter Data for a Test Result . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
System Check Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . 7-8
Resolving Miscellaneous System Check Error Conditions . . . . . . . . . . . 7-8
Entering a New ABS/CHK Carton Value: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
Unacceptable Photometer Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
Unacceptable Mean or SD for a Reagent Arm (R1, R2) . . . . . . . . . . . . . 7-10
Unacceptable Mean or SD for the Sampler . . . . . . . . . . . . . . . . . . . . . . 7-11
Unacceptable Mean or SD for the HM Wash System . . . . . . . . . . . . . . . 7-12
Unacceptable LOCI Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-12
Error Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13
Active System Errors Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13
Error Log Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13
Software Error Troubleshooting Help . . . . . . . . . . . . . . . . . . . . . . . . . . 7-13
IMT Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-14
IMT Results Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-14
For Na, K, or Cl results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-14
IMT Error Message Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-14
Acceptable IMT Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-14
Clot Check Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15
Clot Check Bypass . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-16
Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Selecting Instrument Options . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Select or Change an Instrument Option . . . . . . . . . . . . . . . . . . . . . . . . 8-3
System Configuration Menu Screen Fields . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
System Configuration Menu Function Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Possible Dimension EXL System to LIS Communication Configurations . . . . . . . . . 8-6
Clot Check Configuration Menu screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
Configuring Automated System Check Using CHK . . . . . . . . . 8-7
Automatic Cuvette Removal . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8
Sample Auto Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9
Automatic Reflex Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
Setting Up an Automatic Reflex Test . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-10
To Use Automatic Reflex Test Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11
To Deactivate Reflex Testing for a Specific Assay . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11
Automatic Panic Rerun . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-12
Setting Up an Automatic Panic Rerun . . . . . . . . . . . . . . . . . . . . . . . . . . 8-12
Automatic Reflex Testing and Panic Rerun Report Slips . . . . . 8-13
Using Calculated Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-15
Calibration Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-19
Define Calibration Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-19
Scanning Barcode Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-19
Entering Data Manually . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-19
8
Edit Calibration Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-19

Define Calibration Auto Acceptance Parameters . . . . . . . . . . . . . . . . . 8-20
Correlations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-23
Correlation of the Dimension EXL System with Other Methods . . . . . . 8-23
Correlation Study . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-23
Result Reporting for Correlated Methods . . . . . . . . . . . . . . . . . . . . . . . 8-24
Using the Correlation Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-24
Entering Observed Results for System Calculation . . . . . . . . . . . . . . . . 8-25
Entering Slope and Intercept Calculated Offline . . . . . . . . . . . . . . . . . . 8-26
Removing a Correlation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-27
Printing a List of Correlated Methods . . . . . . . . . . . . . . . . . . . . . . . . . . 8-27
Correlations Date . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-27
Performing Reagent Hydrations . . . . . . . . . . . . . . . . . . . . . . . . 8-28
Hydrating a Specific Cartridge Lot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-28
Cancelling a Reagent Hydration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-29
Hydrating Using the Inventory/Hydration Screen . . . . . . . . . . . . . . . . . 8-29
Setting a Timed Hydration Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-30
Hydrating Using a Pre-programmed Setup List . . . . . . . . . . . . . . . . . . . 8-31
IMT Configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-32
ECO2 Test Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-32
Bleach/Condition Soak Interval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-32
Entering Method Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . 8-33
Automatic Dilutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-36
Automated Urine Dilutions (AUD) - BUN, CREA, CRE2, EZCR, PHOS, and URCA . . . 8-36
Autodilute (AD) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-36
Creating Panel Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-43
HIL Feature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-44
HIL Alert Index Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-45
HIL Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-46
Configuring Touchscreen Alert Keys . . . . . . . . . . . . . . . . . . . . 8-48
Configuring the STAT Status Alert Key . . . . . . . . . . . . . . . . . . . . . . . . . 8-48
Configuring the Supplies Alert Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-49
Configuring Calibration Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-50
Configuring QC Alerts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-50
Configuring the Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-51
Customizing an External Printer Report . . . . . . . . . . . . . . . . . . 8-52
Customize the External Printer Report . . . . . . . . . . . . . . . . . . . . . . . . . 8-52
Create an External Printer Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-52
External Printer Format - Report Slip Example . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-53
Using the Result Monitor Feature . . . . . . . . . . . . . . . . . . . . . . . 8-55
Limits Side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-55
Accumulated Results Side . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-55
F4 Zero Data Function Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-55
Activating or Deactivating an Assay . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-56
Result Monitor Assays and Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-56
Entering Sample ID Information . . . . . . . . . . . . . . . . . . . . . . . . 8-58
Using Test Counters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-62
Storing Laboratory Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-63
How the Data is Stored . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-63
Understanding the Data Fields . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-65
QC Results Fields in qcdat.xls File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-65
Test Results Fields in rsdat.xls File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-66
Daily Maintenance Fields in mtdat.xls File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-67
9
Photometric Calibration Fields in cldat.xls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-69

IMT Logs Fields in imtdat.xls File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-72
Instrument Log Fields in instrdat.xls File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-74
Selecting a Test Result Order . . . . . . . . . . . . . . . . . . . . . . . . . . 8-75
Test Key Assignments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-76
Programming Test Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-77
User-Defined Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-79
Customer Responsibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-80
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-80
Identifying the Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-80
Defining the Reagent and Sample Deliveries . . . . . . . . . . . . . . . . . . . . . 8-81
Reagent Delivery R1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-82
Sample Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-82
Reagent Deliveries R2 and R3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-83
Reagent and Sample Delivery Fields . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-83
Defining the Photometry Reading Times . . . . . . . . . . . . . . . . . . . . . . . . 8-84
Defining the Flex Cartridge Configuration . . . . . . . . . . . . . . . . . . . . . . . 8-85
Flex Cartridge Configuration Fields . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-86
Defining the Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-87
Writing A Calculation Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-87
Using a Predefined Calculation Template . . . . . . . . . . . . . . . . . . . . . . . 8-88
Storing a User-Defined Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-89
Entering User-Defined Method Parameters . . . . . . . . . . . . . . . . . . . . . .8-90
Filling a Flex Cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-90
Loading the Flex Cartridge . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-91
Calibration and QC of User-Defined Methods . . . . . . . . . . . . . . . . . . . . 8-92
Running a User-Defined Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-92
Reviewing a Method’s Kinetics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-93
Method Kinetics Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-93
Using Method Kinetics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-98
Programming Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-99
Programming Structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-99
Implementation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-99
Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-100
Expressions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-102
Numerical Expressions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-102
Logical Expressions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-103
Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-104
Error Message List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-104
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
General Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Biohazard and Probe Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Instrument Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Safety Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Safety Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-4
Symbols Key . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Instrument Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-8
Performing Power Shutdowns and Startups . . . . . . . . . . . . . . 9-9
Types of Shutdowns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9
Important Power Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-9
Performing a Controlled Power Shutdown . . . . . . . . . . . . . . . . . . . . . . 9-10
Restoring Power After a Controlled Shutdown . . . . . . . . . . . . . . . . . . . 9-10
Performing an Emergency Shutdown . . . . . . . . . . . . . . . . . . . . . . . . . . 9-10
10
Restoring Power After an Emergency Shutdown . . . . . . . . . . . . . . . . . 9-11

General Code Compliance Information . . . . . . . . . . . . . . . . . . 9-12
Safety Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-12
Barcode Scanner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-12
Installation Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13
Space Requirements For Dimension EXL with LM System . . . . . . . . . . 9-13
Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13
Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13
Minimum Clearances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13
Space Requirements For Dimension EXL 200 System . . . . . . . . . . . . . 9-14
Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-14
Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-14
Minimum Clearances . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-14
Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-14
Power Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-14
Leakage Current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-15
Water Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-15
Room Temperature Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-17
External Un-interruptible Power Source (UPS) . . . . . . . . . . . . . . . . . . . 9-17
Printer Shelf . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-18
Additional Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-18
Phone Line . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-18
Host Interfacing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-18
English to Selected Language Keymap . . . . . . . . . . . . . . . . . . . . . . . . . 9-19
Instrument Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-20
HM Wash Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-20
IMT Tubing Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-21
Pump Panel Tubing Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-22
Cuvette Film Diagram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-23
Manual Review Documentation . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Dimension System Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
Dimension EXL with LM/EXL 200 Integrated Chemistry
System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-2
Log 1 - Daily Maintenance Log . . . . . . . . . . . . . . . . . . . . . . . . . 11-3
Log 2 - Daily System Check ABS . . . . . . . . . . . . . . . . . . . . . . . . 11-6
Log 3 - Daily System Check CHK . . . . . . . . . . . . . . . . . . . . . . . . 11-9
Log 4 - QuikLYTE Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-12
Log 5 - Weekly/Monthly Maintenance . . . . . . . . . . . . . . . . . . . 11-14
Log 6 - Instrument Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-16
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
11
12
Dimension EXL with LM/EXL 200 System Operator’s Guide System Overview
Chapter 1: System Overview
1-1
System Overview Dimension EXL with LM/EXL 200 System Operator’s Guide
Intended Use
The Dimension® EXL™ with LM system and Dimension® EXL™ 200 system are in
vitro diagnostic devices that are intended to measure a variety of analytes in
human body fluids. The systems utilize photometric, turbidimetric,
chemiluminescence and integrated ion selective multisensor technology for
chemical and immunochemical applications for clinical use.
This guide is used to supplement a laboratory’s procedure manual. The College
of American Pathologists (CAP) has approved the use of a manufacturer’s
procedure manual as a component of the overall departmental procedures if it
complies with Clinical and Laboratory Standard Institute (CLSI, formerly
NCCLS) GP2-A5 guidelines.
1-2
Using this Guide

Clinical and Laboratory Standard Institute. Clinical Laboratory Technical
Procedure Manuals. Approved Guideline. CLSI (NCCLS) publication GP2-A5,
Wayne, PA, NCCLS; 2006.
Any modification to or deviation from the manufacturer’s procedure must be
clearly documented. This guide has been written to comply with CLSI
GP2-A5 guidelines.
Information that is specific to the structure and operation of each laboratory
should be added. The guide should be reviewed and signed by laboratory
supervision at required intervals. A “Manual Review Documentation” log sheet
is provided after the appendix to assist in documentation.
Only trained operators should operate the instrument and perform the
maintenance procedures in this guide. Each procedure has been written as a
separate stand-alone procedure. However, it is very likely that an entire
portion of maintenance (e. g., monthly maintenance) will be performed at the
same time.
If all maintenance procedures are performed at the same time, wait to perform
one System Check (or pump prime routine, etc.) after all procedures are
completed.
Throughout the rest of this Operator’s guide, the Dimension EXL with LM and
Dimension EXL 200 system will be referred to as the Dimension EXL system
unless otherwise noted.
For Additional Help

For additional help in operating or understanding procedures or information in
this manual, call the Customer Care Center - Technical Solutions.
• For help with instrument problems, call: 1-800-441-9250.
• For help with chemistry problems, call: 1-800-435-7222.
• Outside the U.S., refer to the local support team.
1-3
How this Guide is Organized
Chapter Contains
1: System Overview Describes the contents of the guide, as well as

an overview of the features, hardware
components and software for the Dimension
EXL system.
2: System Operation Describes everything that needs to occur in

order to run a sample.
3: Sample Reports Describes the reports and procedures that

contribute to the preservation of a sample.
4: Calibration & Quality Controls Procedures for reagent calibration and quality
control on the Dimension EXL system.
5: Maintenance Procedures for preventive maintenance

(cleaning, lubricating and replacing
components) on the Dimension EXL system.
6: Alignments Procedures for aligning instrument

components.
7: Troubleshooting Procedures for resolving problems on the

Dimension EXL system.
8: Configuration Procedures for customizing features of the

Dimension EXL system to your laboratory’s
specifications.
Appendix Safety Labels, Compliance, Power Down/Up

Process, Installation Specifications, Manual
Review forms, Maintenance Logs and
Instrument Logs
1-4
Overview of the Dimension EXL System

The Dimension EXL system is a discrete, random-access, microprocessor-
controlled, instrument. It measures a variety of analytes including enzyme
activities in body fluids and has the ability to check for clots during sample
aspiration.
A clot check is performed during the aspiration of all samples and does not
affect turnaround time, time to first result or throughput.
For in vitro diagnostic use.
The system uses Siemens Healthcare Diagnostics Flex® multiple-test reagent
cartridges, disposable reaction cuvettes, Integrated Multisensor Technology
(IMT) with the Siemens QuikLYTE® integrated multisensor to provide rapid,
accurate, and precise test results. The system also uses the heterogeneous
immunoassay (HM) module for processing chromium-based heterogeneous
immunoassays, and the LOCI® module for high-sensitivity homogeneous
immunoassays in both enclosed and competitive reaction formats.
The Dimension EXL 200 system has the same features of a Dimension EXL with
LM System with the exception of the Reagent Management System (RMS).
1-5
Features
Table 1-1: Features: Testing
Testing
Can perform tests in random order.
Can perform automatic reflex testing.
Can perform automatic panic reruns.
Can perform automatic dilutions on patient and QC urine samples.
Can perform up to 440 photometric chemistry tests and 187 IMT test per hour on serum, plasma, urine
and cerebrospinal fluid samples.
Can perform up to 167 heterogeneous immunoassays per hour.
Can produce calculated results.
Can perform automatic rerun capability.
Can perform automatic dilution for over-range samples.
Can detect clots during sample aspiration.
Can process user-defined assays.
Can determine the usability of a sample using the HIL feature.
Can test for electrolytes using the Siemens exclusive QuikLYTE integrated multisensor.
Can process high-sensitivity immunoassays using the Siemens exclusive LOCI technology.
Utilizes automated CHK System Check.
Table 1-2: Features: Consumables
Consumable
Can Perform automatic reagent preparation.
Can hold up to 44 Flex reagent cartridges in a non- CFC refrigeration system.
Can hold an additional 44 Flex reagent cartridges with RMS installed.
Can automatically remove reagent cartridges when these cartridges are empty or their onboard life has
expired.
Can use the Flex reagent cartridge and onboard cuvette manufacturing system.
Table 1-3: Features: QC/Calibration
QC or Calibration
Utilizes automated calibration setup and acceptance.
Utilizes barcoded QC panel processing.
1-6
Table 1-4: Features: Software
Software
Has an easy-to-use computer.
Has ten user-programmable panel keys.
Has the ability to link with other Siemens analyzers (with or without barcode generation capability) or
with a Laboratory Information System (LIS).
Has touchscreen monitor with visual/audio alerts.
Table 1-5: Features: Sample Tubes
Sample Tubes
Uses various sizes and styles of primary sample tubes.
Uses 1.5-mL sample cups.
Uses 1-mL SSC (Small Sample Container) on top of barcoded tubes for short volume samples.
1-7
Major Components of the Dimension EXL System

Figure 1-1: Dimension EXL System
# Description
1 IMT Lid
2 Sample Area
3 LOCI Module
4 HM Area
5 Reagent Lid
6 Touchscreen
7 IMT Area
8 Keyboard
9 Printer Shelf
10 RMS
11 Control Boards
12 Computer
13 Inner and Outer Barcode Readers
14 Pump Panel
15 Cuvette Film Cartridge
16 Flex® Reagent Cartridge Loader
17 Cuvette Waste Container
18 Reagent Area
Note: Dimension EXL 200 system does not have an RMS.
1-8
Major Components of the IMT Area

Figure 1-2: IMT Area
# Description
1 IMT Peristaltic Pump
2 IMT Rotary Valve
3 IMT Port
4 Multisensor Interface Lid
5 Flush Solution
6 Standard A
7 Standard B
8 Salt Bridge Solution
9 Sample Diluent
1-9
Major Components of the HM Area

Figure 1-3: HM Area
# Description
1 Top of vessel feeder track
2 Vessel Holder
3 Wash Probe 2
4 Vacuum Sensor WP2
5 Vacuum Sensor WP1
6 Wash Probe 1
7 Wash Pump 2
8 Wash Pump 1
9 Wash Wheel
10 Incubate Wheel
11 Thermal Ring (Inside incubate wheel)
12 Vessel Shuttle
13 Vessel Gate Solenoid
14 Vessel Shuttle Guide Solenoid
1 - 10
Major Components of the Reagent Area

Figure 1-4: Reagent Area
# Description
1 R2 Reagent Arm
2 Reagent Tray
3 R1 Reagent Arm
1 - 11
Major Components of the Thermal Chamber Area

Figure 1-5: Thermal Chamber Area
# Description
1 Thermal Chamber
2 Thermal Chamber Release
3 Vacuum and Pressure Gauges
4 Flow Meter
5 Compressor
1 - 12
Major Components of the Printer Area

Figure 1-6: Printer Shelf Area
# Description
1 Printer
2 Safety Label
3 Shelf
4 Supports
1 - 13
Major Components of the LOCI Module

Figure 1-7: LOCI Module
# Description
1 LOCI Arm
2 LOCI Reader and Chamber
3 LOCI CAN Communication Board
4 Power Supply
5 Arm CAN Communication Board
6 Arm Drive Gear and Belt
7 Arm Drive Motor
8 Vacuum Assembly
1 - 14
Software Overview
Using the Keyboard
Figure 1-8: Keyboard Layout
The Dimension EXL system Keyboard has six areas which are discussed in the
following sections.
Note: Some of these keys can be used in combination. These are
referred to as keystroke combinations, which are also
described on the following pages.
Test Keys
Use the test keys to select tests and panels of tests.
The test keys labeled P1 through P10 are the panel keys. By programming
groups of frequently used tests to these ten panel keys, a panel of up to 20
tests can be requested with a single keystroke. (See “Creating Panel Keys” on
page 43 of Chapter 8: Configuration). Tests can also be assigned to specific
test keys. (See “Test Key Assignments” on page 76 of Chapter 8:
Configuration).
Figure 1-9: Test Key Panel Setup
1 - 15
Keyboard Overlays
Additional tests may be shown on the overlay above or below the test keys.
To select these tests, press Alt and the key indicated by the overlay. For
example, the TSHL test is on an overlay above the test keys:
Figure 1-10: Keyboard Overlays
Action Keys
Table 1-6: Action Keys
Key Use
Stop The Stop key can be used only with the Control key. This key combination stops
all instrument operations in progress without damaging the instrument. All tests
in progress are aborted; however all scheduled tests are retained in instrument
memory. Press the Reset key to resume operations.
PAUSE The PAUSE key turns the sampler system off, preventing the photometric
sample arm from moving. Press the PAUSE key again to restart the sampler
system.
Reset The Reset key is used to clear error messages on the screen. It initializes any
modules that are not being used and causes the instrument to resume
processing. This key is also used to resume operations if the
Control/Stop key combination is used to halt processing.
Run The Run key causes the instrument to look for and process any new samples. It
is equivalent to the F4: RUN key on the Load List screen.
Function Key
The Function keys, labeled F1–F8, have different actions depending on which
screen is displayed. Keys are identified in the boxes at the bottom of the
screen.
1 - 16
Keypad Keys
Table 1-7: Keypad Keys
Key Use
Delete When entering information in a field, hold down the Shift key and select DELETE
to remove all characters to the right of the cursor in a field.
Exit Press the Exit key to leave the screen that is currently on the display; the system
displays the previous screen. This key operates the same way as the Exit key on the
touchscreen.
Help Press the Help key at any time to get information about the screen that is on the
display or the functions of various keys on the keyboard that are used with that
screen.
Alarm Off When there is a problem with the system, an alarm sounds. Press the Alarm Off
key to turn off this alarm. Press Alarm Off again to enable the alarm.
PgUp Displays the previous full screen, if any.
PgDn Displays the next full screen, if any.
Enter Press ENTER after entering data to store what was entered in the current field or to
activate a command.
Numbers Use to enter numerical data. Numerical data can also be entered using the
Keyboard keys.
Cursor Movement Keys

These keys, commonly referred to as arrow keys, move the cursor on the
screen up, down, right, and left.
The left and right arrow keys move the cursor from data field to data field on
the screen. When pressed with the SHIFT key, the cursor moves one space to
the right or left within that data field.
Keyboard Keys
Table 1-8: Keyboard Keys
Key Use
BACKSPACE Deletes the character immediately to the left of the cursor when entering/
editing data in a field.
ENTER Stores what was entered in the current field or to activate a command.
TAB No function or use on the keyboard.
\ Place the backslash key at the far left of a data field to delete the entire entry in
a data field.
Highlight a character in a data field and press the backslash key to delete all
characters to the right of the cursor.
ALT Used in combination with other keys, displays other screens or performs
routine functions. See “Keystroke Combinations” in the Appendix for a
description of the key combinations.
1 - 17
Help Keys
The Help keys provide help on a specific screen's tasks, Function keys, and in some
cases procedures.
Table 1-9: Help Keys
Keystroke What Appears
ALT+M Pressing ALT + M simultaneously displays only active error

messages.
Help The Quick Index. The Quick Index is a listing of specific tasks and
(From the Operating Menu) how to display the screens where help on performing that task is
available. The Quick Index includes the Function Key sequence to
display those screens from the Operating Menu.
Help Displays information on how to use the screen and the function keys
(From Any Other Screen) that are currently on the display.
SHIFT+Help If the cursor was in a field in which data can be entered (e.g. Patient
Name on the Enter Sample Data screen), information on acceptable
entries for that field appears.
ALT+Help Presents a screen that explains how Help works and a list of the Alt
key combinations. It contains much of the same information
provided in this table.
CTRL+Help Displays a list of information for all operating condition icons. Scroll
down on this page to get information for a particular icon.
1 - 18
Keystroke Combinations
To use a keystroke combination, hold down the first key and press the second
key.
Table 1-10: Keystroke Combinations
Key Combination Function
CONTROL/Stop Stops all operations in progress without damaging the instrument. All tests in
progress are aborted. However, all scheduled tests are retained in instrument
memory.
SHIFT+DELETE When entering information in a field, press SHIFT +DELETE to delete all
characters to the right of the cursor in a field.
SHIFT+EXIT Moves from the current screen directly to the Operating Menu.
SHIFT/--> When entering information in a field, hold down SHIFT and press the right or
left arrow to move the cursor one space to the left or right.
ALT+I Displays the Reagent Cartridge Inventory screen.
ALT+L Displays the Load List – Short Samples screen. To display the All and New
Samples views, press F2: NEXT STATUS.
ALT+M Displays an explanation and troubleshooting information for the error message
that is on the screen.
ALT+N Displays the System Needs screen.
ALT+O Advances the paper feed on the system printer.
ALT+P Prints out the entire screen appearing on the display.
ALT+R When the reagent manager icon appears in the Operating Conditions Status
area of the screen, press ALT+R to see information on why the icon appeared.
ALT+S Displays the Segment Status screen to view the status of either the segment
positions currently loaded on the instrument (On Board Segments view) or all
segments (All Segments view).
1 - 19
Operating Passwords
Operating Passwords let the operator customize the instrument operation to
their work.
1. To start or stop using a password, display the System Configuration
Menu screen.
2. Select F7: PASSWORD and type the password exactly as it appears
below.
Table 1-11: Operating Password
Password What It Does
SHOWCL A chloride test is automatically requested when the Na/K test key is pressed. This
does not require additional sample.
ignoredup The software will not process samples on the instrument that have duplicate
barcode IDs. However, an operator may need to run a load list with samples that
have the same barcode ID by using the password "ignoredup" to ensure those
samples will run.
DATA Turns on Method Diagnostic Data and allows the operator to print filter data for
test result troubleshooting, “Printing Filter Data for a Test Result” on page 7 of
Chapter 7: Troubleshooting
1 - 20
Using the Touchscreen

The Dimension EXL system display has several distinct areas in which a specific
type of information displays. This section describes these areas and the
information they provide.These areas are:
• Instrument Status
• Segment Status
• Operating Conditions Status
• Error Message
• Applications
• Message
• Function Keys
• Alert Keys
Figure 1-11: Touchscreen Overview
Instrument Status Area

At the top of the screen is a row of five boxes. The first three boxes indicate the
processing status of the instrument and its systems. The information that can
appear in each box and its meaning are listed below.
Figure 1-12: Instrument Status Area
1 - 21
Processing Status Box

Table 1-12: Status Message and Meaning
Status Meaning
Standby The system is ready for processing.
Initializing The system is starting up. Samples cannot be processed and access to
the sample wheel is disabled until the system has finished initializing.
Processing The system is processing samples, the IMT system is being calibrated,
or photometric calibrations or reagent hydrations are being
performed.
System Prep Instrument is in system preparation mode.
Can’t Process The system is unable to process samples.
Diagnostics Diagnostic software is being used. Samples cannot process when this
box displays “Diagnostics.” The instrument must be in “Standby” to
access the Diagnostic software.
Photometric Sampler Status Box

Status Meaning
Sampler Idle Remove or add samples.
Sampler Busy The system is using the sample handler or the sample wheel.
Waiting... The PAUSE key was pressed while samples were processing.
The system is waiting for an appropriate place and time to stop the
photometric sampler system.
Waiting...60 The instrument is 60 seconds from pausing. This will count down the
number of seconds until the instrument is paused (“Waiting...59,”
“Waiting...58,” etc.).
Samplers Off Displays when PAUSE is selected. The photometric sampler system
has stopped and will not move until PAUSE is selected again.
Moving Wheel... The instrument is within five seconds of accessing samples in the
sample area.
WARNING: Do not add samples to the sample area when the

box displays "Moving Wheel..." A red light in the
sample area also lights when this status appears.
1 - 22
IMT System Status Box

Status Meaning
IMT OK The integrated multisensor technology (IMT) system is turned on and

is calibrated. IMT tests can be processed.
IMT Paused All activity in the IMT system has been paused. The IMT system will not
move, prime, or calibrate unless the function key is pressed or the
screen is closed.
IMT Calibrating The IMT system is running a calibration. IMT tests can be scheduled
and will be run when status changes to “IMT OK.”
Na, K, Cl One or more of the individual sensors failed calibration or has been
overridden. The color indicates the status of each:
Green = calibrated
Yellow = IMT method has been overridden
Red = not calibrated
IMT Not Calib The IMT system is not calibrated. IMT tests cannot be processed until
the IMT system is calibrated.
IMT Not Config The IMT system has not been configured. IMT tests cannot be
processed.
Date and Time Box

Status Meaning
When Flashing Instrument is in remote access mode and is being controlled by

"Remote Access" Customer Care Center personnel. See “Customer Care Center -
Technical Solutions” on page 3 of Chapter 7: Troubleshooting
WARNING: Remote access may cause unexpected

movement of instrument components.
When Flashing "Local Instrument is in local access mode and is being controlled by on-site
Access" personnel.
WARNING: Remote access may cause unexpected

movement of instrument components.
1 - 23
Segment Status Area

These boxes indicate the status of each of the six segment positions of the
sample wheel. They show which segments were in each position of the sample
wheel the last time the system scanned the sample wheel.
Figure 1-13: Segment Status Area
Segment Box Meaning
A segment box with a letter in it indicates that the instrument has

scanned the sample wheel and identified that lettered segment (the
number in the segment box at the left corresponds to its position in the
segment wheel).
If the background color is GREEN:
All work is completed or no work is required for this segment. It can be
removed and replaced with another segment.
If the background color is RED -:
The instrument is processing work on this segment.
• Do not remove or reposition the segment or sample container within
the segment.
• Do not remove sample fluid from any sample container in this
segment.
WARNING: When the background color is red, failure to follow

the above instructions will affect reported results,
abort the segment and may damage the instrument.
A segment box with a dash indicates that the instrument has scanned the
sample wheel and did not identify a lettered segment in that segment
position.
Operating Conditions Status Area

Icons in these boxes indicate the operating condition status of various systems
and consumables on the instrument. These icons appear only when their
systems or consumables are not within normal operating levels or require
replacement soon. When the icons appear, press CTRL+Help to find out the
meaning.
Figure 1-14: Operating Status Icons
1 - 24
Reagent Temperature
Table 1-17: Icon Symbol and Meaning
Icon Description
Refrigerator Hot: The temperature of the Dimension EXL reagent

cooling system is above specified limits.
Refrigerator Cold: The temperature of the Dimension EXL reagent

cooling system is below specified limits.
1 - 25
Cuvette Temperature
Icon Description
Cuvette Hot: The cuvette heating system temperature is above the

acceptable range for processing. The system stops processing and
no results for the current test are calculated.
Cuvette Cold: The cuvette heating system temperature is below the

HM Hot: The HM heating system temperature is above the

acceptable range for processing. The HM stops processing and no
results for the current test are calculated.
HM Cold: The HM heating system temperature is below the

The LOCI heating system temperature is above the acceptable range

for processing. The LOCI system stops processing and no results for
the current test are calculated.
The LOCI heating system temperature is below the acceptable range

for processing. The system stops processing and no results for the
current test are calculated.
1 - 26
UPS (Uninterruptible Power Source)

Icon Description
A red ON inside this icon indicates that power to the instrument has
just been interrupted and the UPS is in use. An intermittent alarm
also sounds, changing the word to LOW when the instrument is
preparing to shut down before the UPS loses all power. The UPS is
recharged when normal electric power is restored. If LOW appears
continuously while the instrument is connected to the wall outlet,
contact the Customer Care Center - Technical Solution: Inside U.S.:
1-800-441-9250; Outside U.S. Refer to the local support team.
Vessel Feeder Empty

Icon Description
The reaction vessel sensor, located near the top of the vessel feeder
chute, is not detecting a reaction vessel. Add reaction vessels to the
holder or check for a vessel jam in the vessel transfer system.
Cuvette Film Cartridge

Icon Description
Indicates the number of cuvettes remaining in the cuvette film

cartridge. Replacement of the cuvette film cartridge will be required
shortly.
1 - 27
Reagent Manager
Icon Description
The system has a problem with entering or removing reagent

cartridges, the number of empty slots in the reagent tray is 5 or less,
or a reagent cartridge has been placed in the reagent tray which
would force calibration of a third lot. Press ALT/R to view why this
icon is blinking and to remove the icon from the screen.
Additional Reagent Manager Icon Information:

• A number appearing with the icon indicates the total number
of empty slots remaining in the Dimension EXL system reagent
tray.
• If the word FULL appears in black with the icon, the reagent
tray is full.
• If the word FULL appears in red, the instrument has a system
need for a new reagent cartridge to process tests but there is
no room on the reagent tray. A reagent cartridge must be
removed before one can be inserted.
Printer
Icon Description
ERR- There is a communication problem between the PC and the

printer. Make sure the printer platen is in the down position. Make
sure there is paper in the printer.
Short Sample
Icon Description
One or more sample containers in the current Load List does not
have enough sample volume to run all its requested tests. Press
ALT+L to view a list of these short samples. See “Resolving a Short
Sample Detected” on page 13 of Chapter 3: Sample Reports.
1 - 28
Check Needs
Icon Description
The yellow Needs Check icon appears when the system is checking
itself for any needs to process the Load List.
If the red Check Needs icon appears, the system has found needs
that require operator attention before samples can be processed.
Press ALT+N to display the System Needs screen to see which needs
are required. To fill these system needs, see “Responding to System
Needs” on page 9 of Chapter 2.
Alarm Status
Icon Description
The alarm is sounding. A message appears in the error message area

indicating the reason for the alarm.
The alarm has been turned off by the operator. If an error condition
occurs, the alarm will not sound; however, a message indicating the
reason for the alarm appears in the error message area.
Clot Check Status

Icon Description
Indicates that the Clot Check Error sample aborted error has
occurred. It shares the same location as the printer icon. If both a
printer icon and a clot check icon need to be displayed, the screen
will flash from one icon to the other.
Indicates that the Clot Check feature is turned off. It shares the same
location as the printer icon. If both a printer icon and a clot check
icon need to be displayed, the screen will flash from one icon to the
other.
1 - 29
Error Message Area

The area below the segment status and the operating conditions status area is
used to display error messages. If system malfunctions occur, an appropriate
error message displays in red. Press ALT+M key combination to see if there is
Help to resolve the error message.
When an error message displays in this area of the screen, press the Reset key
to clear the message before system processing will continue.
Applications Area
Below the error message area is the applications area, where sample data is
either entered or edited and test requests are made. The color of the words in
the Application Area of any screen indicate whether information in that field
can be changed:
• Black indicates a text field. Information cannot be changed.
• White indicates a data field. Information can be changed.
Message Area
The message area is below the applications area. This area can contain the
following kinds of messages:
Table 1-28: Message Area Type and Meaning
Message Type Meaning
Prompt When the system needs additional information about a certain task, it
displays a message and waits for a response.
Question The system displays query messages when action is required; or if a

required key has not been pressed or a certain task has not been
performed.
Information The system informs the operator what it is currently doing.
Function Keys Area

Figure 1-15: Function Key Area
The function keys area is located at the bottom of the screen. It contains two
rows of four boxes each. The titles on these eight boxes correspond to the
eight function keys, F1 through F8, on the keyboard.
1 - 30
Alert Keys
Five alert keys are displayed vertically on the left side of the screen. These keys
change color to alert situations that require attention. Select the key to find
out the reason for the alert.
Table 1-29: Alert Key Type and Purpose
Key Purpose
STAT Status Displays the STAT Samples screen. Shows the STAT requests that are
pending, in-process, and completed.
Sample Alert Displays the Sample Alert screen. Shows rerun status of sample
requests which encountered exceptions while processing (autodilute,
reflex, panic repeats, process errors)
Supplies Displays the Reagent Cartridge Alerts screen. Shows Flex reagent
cartridge lots which are nearing an operator-defined depletion
threshold. Warns that it is time to load cartridges for specific methods.
QC Alert Displays the QC Tests Out of Range screen. Shows the method, QC level
and high or low status of QC tests.
Calib Alert Displays the Calibration Alert screen. Shows onboard methods/lots and
the amount of time left to calibration expiration. Shows onboard lots
which have triggered configurable calibration alert criteria.
Additional Touchscreen Keys

Table 1-30: Touchscreen Key Type and Purpose
Key Purpose
Help Shows instructions about the screen/fields displayed in the Applications

Area. From the Operating Menu, provides a Quick Index listing of tasks.
Run Looks for and processes new samples.
Home Closes the currently displayed screen and returns to the Operating
Menu (Home) screen.
Enter Select Enter after entering data to store what was entered in the
current field or to activate a command.
Exit Closes the currently displayed screen and returns to the previously
displayed screen.
Arrow Keys Moves the cursor from field to field on the screen displayed in the
Applications Area.
1 - 31
1 - 32
Dimension EXL with LM/EXL 200 System Operator’s Guide System Operation
Chapter 2: System Operation
2-1
System Operation Dimension EXL with LM/EXL 200 System Operator’s Guide
Daily Setup
Overview
The Daily Setup procedure includes four tasks:
• Cleaning the sample area and emptying cuvette waste
• Performing Daily Maintenance
• Running a System Check
• Recording the Daily Maintenance results
• Onboard Maintenance Logs provide the capability to document daily,
weekly, and monthly logs either on paper or in the on-board electronic logs
saved on the instrument.
Note: Systems with the RMS configured should refer to the RMS
Operator’s guide for additional Daily Setup tasks.
Cleaning the Sample Area and Emptying Cuvette Waste

1. With the instrument in standby, select PAUSE.
2. Raise the IMT and reagent lids.
3. Make sure lids are fully open to avoid injury while performing
maintenance.
Note: During diagnostics, modules are moving. Be aware of moving
parts while performing diagnostics.
4. Remove all segments from the sample area.
5. Clean the inside of the sample area with a damp cloth.
6. Put the segments back into the instrument.
7. Close the reagent and IMT lids.
8. Select PAUSE.
9. Open the cabinet door and cut the cuvette string approximately 12
inches down from the instrument.
Note: Ensure to cut between two cuvettes to prevent spilling fluids
from a sealed cuvette.
10. Empty the accumulated cuvette waste.
WARNING: The cuvettes and the contents of the cuvettes may present a
biohazard or chemical hazard. Follow standard laboratory
procedures for protection from biohazards and chemicals
when performing maintenance and troubleshooting
procedures
11. Update the Maintenance Log.
2-2
Daily Maintenance
1. Select F4: SYSTEM PREP > F8: DAILY MAINT.
Note: If all System Check Means are failing and ABS/CHK lots were
recently changed, enter the carton value from the ABS/CHK
carton end flap every time a new ABS/CHK lot is used.
2. Refer to the section “Understanding the System Counters Screens” on
page 7.
Note: Additional maintenance items appear in red. Check the RMS
Operator’s Guide for RMS Daily Maintenance requirements.
Performing a System Check Using ABS

Note: Complete the following procedure with an ABS reagent
cartridge in the instrument as well as fresh ABS solution from
the same lot as the ABS reagent cartridge.
1. Fill a sample cup with ABS solution from an unopened well of an ABS
reagent cartridge.
2. Select F4: SYSTEM PREP > F8: DAILY MAINT, enter a segment position
for this sample cup and operator initials. Place the cup in that position
and load the segment.
3. Close all instrument lids.
4. Select F1: START.
Performing a System Check Using CHK

1. Select F4: SYSTEM PREP > F8: DAILY MAINT, enter operator initials.
3. Press Exit.
Note: To abort a System Check from the Operating Menu, select F4:
SYSTEM PREP > F4: SYSTEM CHECK > F2: REVIEW DATA >
F4: ABORT CHECK.
Recording Manual Daily Maintenance Results

When the System Check results are printed, these items may also be entered in
the Maintenance Log:
• Temperatures for cuvette, reagent, HM, RMS hydration, and RMS reagent
from the printout. Acceptable temperature ranges are shown in Table 2-1.
• Photometer filter wavelength values are all within range. Confirm these
values are within the ranges specified in Table 2-2 for ABS and Table 2-3
for CHK.
• The mean and SD results for the R1 and R2 reagent arms, sampler, HM
wash probes, and RMS, and the highest LOCI value from the System Check
printout. Acceptable results are listed in Table 2-2 for ABS and Table 2-3 for
CHK.
2-3
Unacceptable System Check results appear on the printout in white letters on a

black background. An asterisk indicates cuvette processing problems. If the
System Check printout indicates that any results are not acceptable, “System
Check Troubleshooting” on page 8 of Chapter 7: Troubleshooting“.
Table 2-1: System Temperature
System Temperature Specifications
Cuvette 36.8°C – 37.2°C
Reagent 2°C – 8°C
HM* 37.3°C – 39.6°C
RMS Hydration 2°C – 8°C
RMS 2°C – 8°C
• * The temperature range listed here is of the HM ring itself, not the air bath or liquid in a reaction
vessel. In order to maintain a constant temperature inside the reaction vessel, the system
compensates for ambient temperature, thus varying the HM ring temperature. It is common for the
HM ring temperature to vary throughout the day in order to compensate for ambient temperature.
In this manner, the system is able to maintain the temperature of the liquid in the reaction vessel
between 36.5º C and 37.5º C.
• Numbers in brackets such as [37.0] mean that the temperature is not current. Dashes inside
brackets [--] mean that one or more requirements for monitoring temperature are not met, for
example, the lid may be open.
Note: The Dimension EXL system monitors LOCI temperatures

automatically, no operator action is required.
Table 2-2: System Check Specifications For ABS
System Check Specifications
Photometer –2.5 to +2.5 mAU for the 293nm filter only

–1.5 to +1.5 mAU for all other filters
LOCI® All values 0.001 to 0.144 KCounts
Mean SD
Reagent #1 Assay value listed on the end flap of ≤ 3.8

the ABS carton ±12 mAU

Sampler 10% of the assay value listed on the ≤ 0.8

end flap of the ABS carton ±2 mAU
HM Wash 10% of the assay value listed on the ≤ 1.6

RMS Assay value listed on the end flap of the ≤ 3.8

ABS carton ±12mAU
Sample Probe Cleaner Pass
Reagent Probe Cleaner Pass
2-4
Table 2-3: System Check Specifications For CHK

Mean SD

the CHK carton ±15 mAU


end flap of the CHK carton ±2 mAU


CHK carton ±15mAU
Note: If the System Check fails and tests are aborted, go to the Error
Log screen. Display the Error Log screen by navigating to: F5:
PROCESS CONTROL > F6: ERROR LOG, and resolve any error
messages and rerun the system check. See “System Check
Troubleshooting” on page 8 of Chapter 7: Troubleshooting.
Using the Daily Maintenance Log Screens

1. From the Operating Menu, select F4: SYSTEM PREP > F8: DAILY MAINT
> F7: MAINT LOGS to display the Daily Maintenance Overview screen.
2. Press ENTER to toggle from No to Yes and verify that cuvette waste was
emptied.
Note: The Date Field will update upon selecting the ENTER key.
3. Select F1: STORE MAINT to store the current readings into Maintenance
log history.
Note: The Storage of a failed maintenance record is allowed.
4. Select F3: UPDATE TEMP to update temperatures for a log that has failed
because of a temperature error. This function is only used for the
following conditions:
a. Daily Maintenance (including System Check) has been run and
stored.
b. There is a temperature error in a stored log.
Selecting F5: SEARCH BY DATE allows the operator to search for a
history log by a specific date. Enter the date of the maintenance in the
2-5
MM/DD/YY form. Select F6: <== PREV LOG or F7: NEXT LOG ==> to scroll
through stored logs in the system.
Note: The previous 60 logs are stored on the instrument.
5. Select F8: PRINT.
CHK Flex Reagent Cartridge Information

The product is used to check the proper functioning of the sample and reagent
fluid metering systems as well as the photometric measuring system on the
Table 2-4: Flex Reagent Cartridge Information
Reagents Wells Form Ingredient Concentration
1-6 Ponceau S 0.14 mg/mL
Expiration: Refer to carton for expiration date of individual unopened reagent cartridges. Once
unwrapped, cartridges are stable for 30 days.
Open Well Stability: 3 days for wells 1-6.
There are numerous distinct tests processed during a system check, each using
a different fluid delivery sub-system. For each test, the absorbance difference
between two wavelengths of Ponceau S diluted as sample or reagent are
measured by a two-filter (510, 600 nm) endpoint technique. The results of
these determinations must meet the specifications given in the specific
Operator’s Guide. If these conditions are not met, a system malfunction may
be indicated. Refer to the specific Operator’s Guide for troubleshooting
information.
Table 2-5: System Check Tests & Conditions
Test Condition
Temperature 37º C
Wavelength 510, 600 nm
Type of Measurement Bichromatic, endpoint
The system check checks the instrument system performance.

No calibration is required.
As part of daily maintenance, use the Daily Maintenance System Check

procedure to process CHK reagent. The routine will process 5 replicates of a
variety of tests, which verify that sampler and reagent fluidic performance is
within specified limits.
Instruments with HM Systems are configured to run an automated system
check that does not require manual preparation of CHK fluid.
2-6
Understanding the System Counters Screens

Dimension EXL System Counters Screen
To access system counters, select F4: SYSTEM PREP > F6: SYS COUNTERS.
Note: Items where Cycles exceeds the Clean At or Replace At field
are displayed in red.
When the Dirty Windows display is not zero (0), perform the procedure
“Cleaning Cuvette Windows” on page 28 of Chapter 5: Maintenance.
Note: For HM and RMS modules: See “Using the Instrument Log
Screen” on page 7 of this chapter, and RMS Operator’s Guide.
Using the Instrument Log Screen

1. Select F4: SYSTEM PREP > F8: DAILY MAINT > F6: INSTRUMENT LOG.
2. Select F1: NEW TASK to enter the following information
a. Enter Operator initials.
b. Enter the task to be performed.
c. Enter any comments.
3. Select ENTER.
4. To delete a log entry, select F2: DELETE ENTRY and complete the
following tasks:
a. Enter operator initials.
b. Enter any comments.
5. Select F3: SEE DEL INFO/SEE ORG INFO, to toggle the view between the
deleted task and the original task entered, its date, the initials and the
comment entered before the line was deleted
HM System Counters Screen

The HM System Counters screen shows the status of the consumables for the
HM module. Replace items appearing in red or with Fill Level Est field of 5% or
less or with 0 days left before HM tests are run.
Select F4: SYSTEM PREP > F6: SYS COUNTERS > F6: HM COUNTERS.
When the count for reaction vessels reaches 1500, a “Check Reaction Vessel
Waste - Reset Counter” error message appears and unloading of additional
vessels is prohibited. Empty this waste container and reset this counter to
continue unloading reaction vessels. For more information see “Adding/
Discarding Reaction Vessels” on page 20 of this chapter.
2-7
Managing Offboard Reagent Lots

The Daily Maintenance printout contains a list of the reagent cartridge lot
calibrations that either have expired or are about to expire within a set time
period.
Keep only those lots that are currently being used or still remain in the
laboratory’s refrigerator. This procedure permanently removes these lots and
their calibrations from instrument memory, significantly reducing the length
of the printout.
1. Select F4: SYSTEM PREP > F8: DAILY MAINT.
Note: To display methods on this list, enter the time duration for
displaying methods on the Calibration Status List. See “Using
Calibration Status Lists” on page 19 of Chapter 4: Calibration
and Quality Control.
2. Select F5: OFFBOARD LOTS.
3. Enter the password and select ENTER.
4. Choose the lot that will be permanently removed from the system
memory.
5. Move the cursor to the lot and select F3: DELETE.
6. Repeat this step for each lot to be permanently removed from the system
memory.
Note: Ensure that the correct method lot number is displayed on
the screen before deleting. After permanently deleting a lot
number from instrument memory, the lot must be
re-calibrated before another reagent cartridge with that lot
number can be used.
2-8
Supplies
System Needs
Adding:
• Reagent Cartridges
• IMT Consumables
• Cuvette Film Cartridges
Performing:
• Calibration/Verification on photometric methods, LOCI methods, and the
IMT system
• Quality Control
Before beginning sample processing, the system checks to see if any reagents
or supplies are needed or if any process control functions (calibration or quality
control) need to be performed.
When either F2: PROCESS SINGLE from the Enter Sample Data screen,
F4: RUN from the Load List screen, or RUN is selected, the system checks its
needs (the yellow Needs Check icon appears) for processing the requested
tests.
• If no system needs are required, the system begins processing.
• If system needs are required, the red Check Needs icon appears. Complete
the system needs listed or ignore them (tests that require those needs are
not processed). Tests are processed and reported only if you ignore QC
needs.
• The System Needs screen:
• Shows which system needs must be completed to process all samples on
the Load List. Samples with no system needs are scheduled for processing.
• Shows function keys only for those categories of supplies and procedures
that are needed.
Responding to System Needs

1. When the red Check Needs icon displays, press ALT+N to display the
System Needs screen for the samples on the Load List. Samples that have
no system needs are scheduled for processing.
2. Decide which system needs will be completed. Use Table 2-7
“Understanding System Needs” on page 11to make decisions.
2-9
3. To fill a specific system need, select its function key to see what is
needed. Function keys are displayed only for system needs that must be
filled to run the Load List.
Table 2-6: Function Keys
Function Key Press the function key and follow this procedure
F1: REAGENTS See “Adding Reagent Cartridges ” on page 14 of this chapter.
F2: QC Run laboratory QC for the lots indicated.
F3: CAL/VER See “When to Calibrate or Verify Photometric and LOCI Assays” on
page 3 of Chapter 4: Calibration and Quality Control.
F4: IMT CONSUMS See “Replacing IMT Consumables” on page 22 of this chapter.
F5: IGNORE NEEDS See “Understanding System Needs” on page 11 of this chapter.
F7: SYS COUNTERS To replace the cuvette film cartridge, press F3: FILM LOAD and see
“Replacing the Cuvette Film Cartridge” on page 41 of Chapter 5.
F8: IMT See “Calibrating the IMT System” on page 2 of Chapter 4:

Calibration and Quality Control.
4. If after filling a system need, other system needs are still required, the
System Needs screen displays and allows the operator to press another
function key to fill another need. If no additional system needs are
required, the system begins processing the samples.
2 - 10
Understanding System Needs

Table 2-7: System Needs
Need Occurred Because: If F5: Ignore Needs Is Pressed:
Cartridges Not enough reagent available to run all As many tests as possible are run for
the tests. the assay.
Cuvette Cartridge Not enough film in the cuvette film As many tests as possible are run.
cartridge to make all the necessary
cuvettes.
IMT Consumable The QuikLYTE® sensor or a required IMT As many Na, K, Cl assays as possible
fluid is not sufficient enough to run the are run.
remaining assays.
OR
The time remaining for the QuikLYTE All Na, K, Cl assays are run.
sensor or a required IMT fluid has
expired.
IMT System The IMT system is not calibrated. An IMT calibration is scheduled. If it
fails, no Na, K, Cl assays are run.
QC QC for these lots has not been run All tests are run.
within the specified time period.
Photo Method Calibration status is “Expired” for these All assays are run, but a test report
reagent cartridges. message will appear on the report
slip.
OR
Calibration status is “Never Calibrated” Assays are not run and a test report
for these reagent cartridges. message appears on the report slip.
2 - 11
Supplies Alert
When the Supplies alert key changes to yellow, select the key to display the
Reagent Cartridge Alerts screen.
Figure 2-1: Reagent Cartridge Alerts Screen
Table 2-8: Reagent Cartridge Alert Scenarios
Scenario Description
ACP A single ACP Flex cartridge is on board and has only five tests remaining, five fewer
than the designated alert threshold of 10.
ALB Multiple ALB Flex cartridges are on board, all with the same lot number. The “Tests
Left” field shows the cumulative number of tests from all ALB reagent cartridges.
CHOL Multiple CHOL Flex cartridges from two different lots are on board. The threshold of
161 is compared to the cumulative number of “Tests Left” from all CHOL reagent
cartridges.
When a method displays on the Reagent Cartridge Alerts screen, load enough
reagent cartridges to exceed the “Alert At” threshold for the method (see
“Adding Reagent Cartridges” later in this section).
2 - 12
Review Reagent Cartridge Inventory

The reagent cartridge inventory contains all the information for each
Flex Reagent cartridge currently in the reagent tray. From the Reagent
Cartridge Inventory screen, select a test key on the keyboard to move directly
to that assay in the listing.
Select F4: SYSTEM PREP > F1: INVENTORY.
The Reagent Cartridge Inventory screen can also be accessed by pressing ALT/I
key combination.
Reagent Cartridge Inventory

The reagent cartridge inventory contains all the information for each Flex®
reagent cartridge currently in the reagent tray. From the Reagent Cartridge
Inventory screen, press a test key on the keyboard to move directly to that
method in the listing. The information on this screen is discussed in the table
below.
Note: To access the Reagent Cartridge Inventory screen, press the
ALT/I key combination.
Display the Reagent Cartridge Inventory screen by pressing:
F4: SYSTEM PREP > F1: INVENTORY.
Table 2-9: Reagent Cartridge Inventory Screen Fields
Field Information
Method Assay name abbreviation.
Lot Number The six-character (two letters and four numbers) manufacturing lot number for
the cartridge.
Sequence The unique eight-digit number for each cartridge.

Number
Tests Left The number of reagent tests remaining in the cartridge.
Calib Exp Date The date that the calibration for that lot expires.
System Exp Date The date after which the cartridge will not be used by the system and must be
discarded.
In Use YES (red)The cartridge is currently being hydrated or is being used by the
system to process a Load List or a System Check.
NO (white) The cartridge is not being used.
Note: A yellow "No" in the In Use field indicates that an automatic

removal of the reagent cartridge was unsuccessful. The
cartridge must be removed manually. See “Removing
Reagent Cartridges” on page 16 of this chapter.
2 - 13
Table 2-10: Reagent Cartridge Inventory Screen Function Keys
Function Key Procedure to use:
F1: SHOW HOLDS Using Third Lots of Reagent Cartridges.
F3: REMOVE REAG Removing Reagent Cartridges
F4: ADD REAGENT Manually Entering a Reagent Cartridge Barcode.
F5: PRINT Press to print out entire reagent cartridge inventory.
F6: FIX INVENTORY Removing Reagent Cartridges

F7: REMOVE ZERO’D
F8: REMOVE ALL
Adding Reagent Cartridges

Place reagent cartridges in the loader. The system reads the information on the
barcode label and moves the cartridge into the reagent tray.
Place reagent cartridges into the automatic loader so that its narrow end goes
into the instrument first and its barcode label is on the right side of the
cartridge. For bulk loading on the RMS, if installed, refer to the RMS Operator’s
guide.
WARNING: LOCI cartridges for the Dimension EXL system are

differentiated by color. These cartridges should never be used
on other Dimension systems or the Dimension Vista® System.
WARNING: Do not add any reagent cartridge that:

• Has been used in any other Dimension System
• Has exceeded its on-system expiration period
• Has exceeded its shelf life date
• Is empty
Figure 2-2: Add Reagent Cartridge
2 - 14
If the automatic loader will not insert the cartridge into the instrument, the
loader light blinks and a blinking reagent manager icon displays. Remove the
cartridge from the loader. Press the Alt/R key combination to see why the
reagent did not load.
• If the reagent tray is full, remove a reagent cartridge from the instrument
to make room for an additional cartridge. See “Removing Reagent
Cartridges” on page 16 of this chapter.
• If the reagent cartridge barcode could not be read, see “Manually entering
a Reagent Cartridge Barcode” on page 15 of this chapter.
WARNING: Do not place anything except a reagent cartridge or the

reagent tray alignment gauge into the automatic loader slot.
Doing so could cause operator injury or damage to the
instrument.
Manually entering a Reagent Cartridge Barcode

Use this procedure when the reagent cartridge barcode cannot be read.
1. Record the following information from the reagent cartridge label:
• Assay name abbreviation
• Lot number
• Sequence number
Note: A barcode label appears on each reagent cartridge in the
following standard format: GB0301 25131096.
GB0301 = Lot number (two letters and four numbers);
25131096 = Sequence number (eight numbers)
2. Select F4: SYSTEM PREP > F1: INVENTORY > F4: ADD REAGENT.
WARNING: Do not add any reagent cartridge that:

• Has been used in any other Dimension System
• Has exceeded its on-system expiration period (check
method IFU)
• Has exceeded its shelf life date (check reagent cartridge
wrapper)
• Is empty
3. Put the reagent cartridge into the automatic loader so that its narrow end
goes into the instrument first and its barcode label is on the right side of
the cartridge.
4. When the barcode reader fails to read the barcode this time, use the
keyboard to enter the information recorded in Step 1.
a. Type the assay name abbreviation and select ENTER.
b. Type the lot number and select ENTER.
c. Type the first five numbers of the sequence number and select
ENTER.
2 - 15
d. Type the last three numbers of the sequence number and select
ENTER.
5. Select F1: ACCEPT DATA to confirm the addition of the reagent
cartridge. The automatic loader then places the cartridge into the
system.
Removing Reagent Cartridges

1. Select F4: SYSTEM PREP > F1: INVENTORY.
2. Using the Reagent Cartridge Inventory screen, decide between removing:
• A specific cartridge
• All empty cartridges
• All reagent cartridges
3. Complete using the following appropriate tasks.
Note: To configure the system to remove empty or expired reagent
cartridges automatically, from the operating menu, select
F6: Sys Config and set the Automatic Cartridge Removal field
to "YES". A password is required to change this field.
Note: A yellow "No" in the In Use field indicates that an automatic
removal of the reagent cartridge was unsuccessful. The
cartridge must be removed manually.
WARNING: Wait until the red loader light is blinking before placing hands
or fingers into the loader to remove a reagent cartridge.
To remove a specific reagent cartridge:

1. Move the cursor to the cartridge and then select F3: REMOVE REAG.
2. When the red loader light begins blinking, remove the reagent cartridge
from the loader.
3. Select F1: CONFIRM REMOVE.
To remove all empty reagent cartridges:
1. Select F7: REMOVE ZERO’D.
2. Remove the reagent cartridges from the loader as they arrive from the
reagent tray.
To remove all reagent cartridges:
1. Select F8: REMOVE ALL.
2. Remove the reagent cartridges from the loader as they arrive from the
reagent tray.
2 - 16
To remove a reagent cartridge when a barcode cannot be read:

1. Remove the reagent cartridge from the loader.
2. Check the barcode on the cartridge to be sure it is the one to be
removed.
3. Select F6: FIX INVENTORY on the Reagent Cartridge Inventory screen.
4. Move the cursor to the reagent cartridge and select F3: VERIFY SLOT.
5. When prompted, select F2: REMOVE DATA.
6. Select F1: VERIFY ALL to verify the entire inventory.
Using Third Lots of Reagent Cartridges

When a third lot is loaded onto the system, a blinking reagent manager icon
displays. Select ALT+R to see why this icon displayed contains the following
message: A reagent cartridge has been added which would force
calibration of a 3rd lot. It has been stored as method ‘HOLD.’ Please go into
the inventory 3rd lots screen to replace a currently calibrated lot or
remove it from inventory.
To begin using a third lot of reagent cartridges:
1. Select F4: SYSTEM PREP > F1: INVENTORY > F1: SHOW HOLD > F1:
SHOW 3rd LOT.
2. Move the cursor to the reagent cartridge that will be used. Press
F1: REPLACE LOT.
3. Since this action permanently removes a previous lot ID from instrument
memory, the system displays the message: New lot would replace
calibrated lot (Lot ID that will be replaced). Do you approve? (y/n).
4. Press Y to confirm removal of this lot’s calibration from system memory.
If this lot will not be replaced, press N.
Note: To remove a third lot loaded by mistake, move the cursor to
the reagent cartridge. Select F3: Remove Reag. The cartridge
will be moved to the autoloader for removal.
2 - 17
Replacing HM Consumables
Replacing HM Fluids
The HM module requires three fluids:
• Chemistry Wash
• Reagent Probe Cleaner
• Sample Probe Cleaner
The volume of chemistry wash, reagent probe cleaner, and sample probe
cleaner is monitored by a low level sensor in each bottle.
WARNING: Do not pool the Chemistry Wash solution. To prevent

contamination of these solutions, wear clean gloves when
handling the pump assemblies.
Replace these fluids when less than 5% remains in the bottle, when an error
message indicates that the bottle is empty, or when Chemistry Wash has been
opened for 30 days.
1. With the system in standby, select
F4: SYSTEM PREP > F6: SYS COUNTERS > F6: HM COUNTERS.
Note: To display the HM System Counters screen from the System
Needs screen, select F7: SYS COUNTERS >
F6: HM COUNTERS. To display from the Daily Maintenance
screen select F3: CHECK HM COUNTS.
2. Open the system doors.
3. Press the pump assembly release button, open the pump assembly and
locate the bottle (chemistry wash, sample probe cleaner, reagent probe
cleaner) to be replaced.
2 - 18
Figure 2-3: Chemistry Wash
Figure 2-4: Probe Cleaner
WARNING: Wear clean gloves to avoid contaminating the dip tube

assemblies and new bottles of solution. When removing a dip
tube assembly from its bottle, touch only the bottle cap; do
not touch the dip tube assembly or allow it to contact the
instrument or floor.
4. Remove the cap from the new bottle.
2 - 19
5. Unscrew and remove the bottle cap/pump assembly on the empty bottle,
and transfer it to the new bottle.
6. If it is necessary to put down the assembly, place it on a clean paper
towel.
7. Screw the bottle cap/dip tube assembly onto the new bottle and place
the bottle in the instrument.
8. Move the cursor to each bottle that was replaced and select ENTER.
9. Select F1: STORE CHANGES.
10. Run QC on HM methods after changing the Chemistry Wash.
Adding/Discarding Reaction Vessels

WARNING: Do not reuse reaction vessels.
Adding Reaction Vessels

1. Raise the reaction vessel cover in the sample area lid.
2. Pour reaction vessels up to the red line on the reaction vessel holder.
CAUTION: Do not overfill the holder. Overfilling may cause jams in the
feeder. Use the red line on the holder as a guide for the maximum
reaction vessel limit.
2 - 20
Discarding Reaction Vessels

1. Open the cabinet door.
2. Remove the HM waste container and remove the waste container
biohazard bag and discard.
Note: Biohazard bags are not supplied by Siemens Healthcare
Diagnostics.
WARNING: The used reaction vessels and waste container liner are
biohazards; use your laboratory’s safe biohazard waste
disposal procedures when discarding.
Figure 2-5: Reaction Vessel Holder
3. Place a new biohazard bag in the HM waste container. Ensure the bag is
fully open and conforms to the inside walls and bottom of the container.
4. Reinsert the waste container.
5. Select F4: SYSTEM PREP > F6: SYSTEM COUNTERS > F6: HM
COUNTERS.
6. Move the cursor to the Vessels in Waste field, and select ENTER to
change the field to YES.
2 - 21
Replacing IMT Consumables

1. Select F4: SYSTEM PREP > F3: IMT > F1: CHANGE CONSUM.
2. Determine which IMT consumables are empty or have no time left, or
need to be replaced.
a. Replace any IMT fluid that does not have enough reagent
remaining to run tests.
b. Replace any IMT fluid that has no time left for its on-board life.
c. Replace the QuikLYTE® sensor if it does not have enough reagent or
time left to run tests.
See Table 2-11 for the recommended minimum fluid volume needed for a
72-hour (or weekend) period with the instrument in Standby.
Table 2-11: Recommended Fluid Volume
Fluid Minimum Volume
Salt Bridge Solution 101
Diluent 39
Standard A 300
Standard B 57
Flush 90
Using the IMT Consumables Screen

2. Select one of the following keys:
a. F1: CHANGE STD A to enter the lot ID
b. F2: CHANGE STD B to enter the lot ID
c. F3: CHANGE FLUSH to enter the lot ID.
d. F5: CHANGE SALT to enter the lot ID
e. F6: CHANGE DILUENT to enter the lot ID
f. F7: CHANGE SENSOR to enter the lot ID
Note: Pressing the enter key without updating the lot will retain the
current lot ID.
2 - 22
Replacing IMT Fluids

2. Replace required fluids:
a. Diluent or Salt Bridge Solution: Unscrew the cap and replace the
used bottle.
b. Standard A, Standard B, or Flush: Remove the tubing connector
from the used bag and push the tubing connector onto a new bag.
Place the new bag in its tray so that the label on the bag faces left.
WARNING: Never pour the remnants of a Salt Bridge Solution bottle or

Diluent bottle into a new bottle. If the Salt Bridge Solution
and Diluent bottles are replaced at the same time, do not let
the dip tubes touch each other.
3. Select the appropriate function key for each fluid replaced.
Table 2-12: Maximum Assays/On-Board Time
Fluid Type Maximum Assays Maximum On-Board Time
Salt Bridge Solution 655
Diluent 1400 21 Days
Standard A 2000 21 Days
Standard B 660 21 Days
Flush 3000
4. Enter new lot number or press enter to retrieve the old lot number.
2 - 23
Replacing the QuikLYTE Integrated Multisensor

Check the Change IMT Consumables screen to determine if the IMT system
should be cleaned before replacing the QuikLYTE sensor. If the bleach/
conditioning soak due is zero (0) days, see “Cleaning the IMT System” on
page 11 of Chapter 5, before replacing the QuikLYTE® sensor.
2. Press down on the rear of the sensor holder and pull the holder forward
just far enough to remove the sensor.
WARNING: Do not pull the holder all the way forward or it may lock.
Forcing it back into position may cause damage.
3. Slide the used QuikLYTE sensor out of the holder.
4. Insert the new QuikLYTE sensor. Apply equal pressure on both sides of
the sensor holder to close it properly.
5. Select F7: CHANGE SENSOR. The screen updates with the maximum
assays and time for the new QuikLYTE sensor.
6. Enter new lot number for the new sensor.
7. Select F8: STORE CHANGE. The system automatically primes the Salt
Bridge Solution and the IMT Condition and Dilution Check screen
appears.
2 - 24
Running a Dilution Check

The dilution check monitors the accuracy and precision of the 1:10 sample
dilution ratio made by the IMT diluent pump.
Table 2-13: Dilution Check Chart
Only Always Never
Run a dilution check as part Refrigerate bottles of Dilution Never run a dilution check on a
of the replacement Check solution sensor that has already been used
procedure for the QuikLYTE to run samples
sensor
Use the same bottle of Dilution Never use Dilution Check solution
Check solution when checking from a bottle that has less than
performance across multiple one inch of fluid remaining in it
instruments
Never rerun a dilution check using
the same sample cup. Always pour
a fresh cup
1. Select F4: SYSTEM PREP > F3: IMT > F4: COND /DILCHK.
2. At the IMT Condition and Dilution Check screen, type the segment
position for the conditioning sample in the Start at Position field.
Note: Select a segment that has two consecutive positions with
adapters available
3. Select ENTER.
4. Select F4: COND & DILCHK to update assigned positions for the
conditioning and dilution check fluids.
5. Fill a sample cup with conditioning sample (fresh plasma or serum) and
place it into its assigned position shown on the screen.
6. Remove the cap from the Dilution Check Solution bottle.
7. Fill a sample cup by pouring directly from the bottle and load this sample
cup into its assigned position shown on the screen.
8. Select F5: START. An IMT calibration is scheduled automatically with the
dilution check.
a. If the dilution check passed, continue with Step 9 below.
b. If the dilution check failed, refer to the section “Resolving a Failed
Dilution Check ” in this chapter. When the dilution check passes,
running an IMT calibration is not required.
c. If the IMT calibration fails, press ALT+M and follow the help
procedures to resolve why the IMT calibration failed.
9. Review the IMT results on the IMT log electronically, or record the
calibration and dilution check results from the printout on the QuikLYTE
Results Log sheet.
10. Run QC for Na, K, and Cl.
2 - 25
Resolving a Failed Dilution Check

A dilution check that is not acceptable generates a printout with the status of
FAIL in reverse print. A dilution check will fail if:
• The bias is greater than ±1%
• The standard deviation (SD) for Na is ≥ 1.4 or for K is ≥ 0.04
• The dilution check did not completely process (or did not process properly)
If both the bias and SD are unacceptable, resolve the SD problem first.
Follow the appropriate procedure to correct a failed dilution check.
If the Bias Is Greater than ±1%:

1. Select F4: SYSTEM PREP > F3: IMT > F6: REVIEW DILCHK.
2. Select F1: CORRECT BIAS. At the prompt, Do you want the dilution
calibration factor to be corrected? (y/n), type a Y for yes.
a. If the Bias field corrects to 0%, record both the FAILED and the
PASSED dilution check results from their printouts on the QuikLYTE
Results log sheet and then run QC for NA, K, and Cl.
b. If the Bias field does not correct, continue with Step 3. When the
bias does not correct, the following message displays: The
calibration is beyond the allowable limits. Prepare a fresh cup
of Dilchk solution, select F4: RUN DILCHK or press Help key.
3. If the Bias field does not correct to 0%, follow the steps below:
a. Replace the bottle of QuikLYTE Sample Diluent.
b. Use a new bottle of Dilution Check solution to rerun the dilution
check.
4. Select F4: RUN DILCHK to display the IMT Condition and Dilution Check
screen.
5. Select F2: DILCHK and then pour fresh Dilution Check solution into a new
sample cup. Place it in the assigned position indicated on the screen.
7. After running the dilution check:
a. If the dilution check passes, record the results from the printout on
the QuikLYTE Results log sheet and then run QC for Na, K, and Cl.
b. If the dilution check does not pass, refer to the appropriate
discussion in this section to resolve the issue.
c. If the bias still fails, and selecting F1: CORRECT BIAS does not
correct it, contact the Customer Care Center - Technical Solution:
Inside U.S.: 1-800-441-9250; Outside U.S. Refer to the local support
team.
2 - 26
If the Na and/or K Standard Deviation (SD) Is Unacceptable:

1. Select F4: SYSTEM PREP > F3: IMT > F3: ALIGN PRIME.
2. Check the IMT pumping rate field. If the IMT pumping rate is less than 68,
replace the X tubing inside the IMT pump.
3. See “Sample Probe to the IMT Port Alignment” on page 35 of Chapter 6:
Alignments and complete the procedure.
4. Perform another dilution check using fresh Dilution Check solution in a
new sample cup. See “Running a Dilution Check” on page 25 of this
chapter, beginning at Step 4.
the QuikLYTE Results log sheet and then run QC for NA, K, and Cl.
b. If the SDs are now acceptable but the bias fails, see “If the Bias Is
Greater than ±1%:” on page 26 of this chapter.
c. If the SDs are still unacceptable, contact the Customer Care Center -
Technical Solution: Inside U.S.: 1-800-441-9250; Outside U.S. Refer
to the local support team.
If the Dilution Check Did Not Process Completely

1. Select F4: RUN DILCHK to display the IMT Condition and Dilution Check
screen.
2. Select F2: DILCHK. Pour fresh Dilution Check solution into a new sample
cup. Place it in the assigned position indicated on the screen.
the QuikLYTE Results log sheet and then run QC for NA, K, and Cl.
b. If the dilution check does not pass but all the results are complete,
refer to “Resolving a Failed Dilution Check ” on page 26 of this
chapter.
c. If the dilution check still does not process completely, contact the
Customer Care Center - Technical Solution: Inside U.S.: 1-800-441-
9250; Outside U.S. Refer to the local support team.
2 - 27
Using the IMT Logs

1. Select F4: SYSTEM PREP > F3: IMT > F5: IMT OVERVIEW > F1: IMT
LOGS.
2. Select F1: STORE DATA to store the current log readings.
3. Selecting F2: SEARCH BY DATE allows the operator to enter and view an
IMT log for a specific date. Enter the date of the maintenance in the
following format: MM/DD/YY.
Note: If the instrument is formatted for international date, use the
following format DD/MM/YY.
4. Select F3: SEARCH CAL ID to search and view an IMT log by its calibration
id.
5. Select F5: VIEW UNCORRECTED/VIEW CORRECTED to view corrected
and uncorrected DilChk values.
6. Select F6: <== PREV LOG or F7: NEXT LOG ==> to scroll through stored
logs in the system.
7. Selecting F8: SRCH LST DILCHK displays the last DILCHK recorded.
8. To print an IMT log, select F4: PRINT.
9. Ensure that log data is transferred monthly. Refer to the following
procedure: “Storing Laboratory Data” on page 63 of Chapter 8:
Configuration.
2 - 28
Sample Container Information

Types of Containers
The following types of sample containers can be used on the Dimension EXL
integrated chemistry system:
• Sample cup with lid.
• Small sample container (SSC) supplied by Siemens.
• Unstoppered 5 mL, 7 mL, and 10 mL primary sample tube.
• Pediatric tubes of various sizes and capacities.
All sample containers require an adapter to load them into the sample wheel
segments except for the 10-mL primary sample tube.
When loading a 5 mL or 7 mL primary sample tube, use only the adapters that
were shipped with the Dimension EXL system.
Types of Segments
There are three colors of segments (black, yellow, and orange) available from
Siemens for use in loading sample containers onto the sample wheel. All are
identical except for their color. It is useful to use the yellow and orange colored
segments to:
• Designate SSC segments.
• Differentiate sample cup and tube segments.
• Identify STAT segments.
• Identify segments with calibrators and verifiers.
• Identify instruments by segment colors (in multi-instrument laboratories).
• Separate work from satellite or other labs.
Using Sample Cups

The Siemens Sample cup holds a maximum of 1.5 mL of sample. The dead
volume in a Siemens sample cup is 30 µL.
WARNING: Ensure that prior to processing a sample cup, sufficient

sample is present in the cup to allow for any possible
automatic rerun of tests from that cup. If certain instrument
options are turned on (autorerun, autodilute, automatic
reflex, automatic panic rerun, or HIL feature), insufficient
sample in a sample cup may cause erroneous results or
system error.
Verify on the System Configuration Menu or Process Control

screens whether these options are turned on. From the
operating menu select F6: SYS CONFIG, or F5: PROCESS CTRL >
F8: MORE OPTIONS > F6: HIL SETUP.
2 - 29
When using sample cups:

• Press the lid on the sample cup securely so it does not interfere with the
sample probe.
Figure 2-6: Sample Cup Lid
• Sample cups must be placed into one of the adapters supplied by Siemens
to load them into a segment. Push the sample cup completely down onto
the adapter.
Figure 2-7: Sample Cup Adapters
# Description
1 Adapter with sample cup
2 Teal 5mL Adapter
3 Beige 7 mL Adapter
2 - 30
Using Primary Sample Tubes

Before using primary sample tubes, perform the sample probe maximum
depth alignment using the primary tube and, if applicable, adapter
combination that sits the highest in a segment. See “Sample Probe Maximum
Depth Alignment” on page 36 of Chapter 6: Alignments. Ensure that there is
sufficient sample for the requested tests. See “Checking for Adequate Sample
Volume for Processing” on page 35 of this chapter.
When using primary sample tubes:
• Follow the manufacturer’s recommendations for factors such as tube
storage temperature and orientation, clotting time, spin time, and RPMs
(g force).
• Always inspect the tube after centrifugation to ensure there is sufficient
sample for the requested tests.
• Remove the stopper and use an appropriate adapter, if necessary, to load
the tube into a segment.
• Use tubes with dimensions as listed in Table 2-14.
Table 2-14: Primary Sample Tubes
Adapter* Adapter
D L
Size Color
13.0 mm 75.0 mm* 5-mL (green/teal)
13.0 mm 100.0 mm* 7-mL (beige)
16.0 mm 100.0 mm none n/a
* requires using a Siemens adapter
2 - 31
Using Small Sample Containers (SSC)

SSCs are intended for use when the probe cannot reach the sample or when a
whole blood test is requested. Using an SSC allows for efficient sample
processing by retaining the use of the barcode information on a primary tube.
To configure the instrument to use SSCs:
• Display the Sample ID/Computer Menu screen and then:
• Enter the inside diameter of the Siemens SSC (8 mm).
• Designate SSC segments. See “Entering Sample ID Information” on
page 58 of Chapter 8: Configuration.
• Perform the sample probe maximum depth alignment using the SSC and
tube (and, if necessary, adapter) combination that places the SSC highest
in a segment. See “Sample Probe Maximum Depth Alignment” on
page 36 of Chapter 6: Alignments.
WARNING: Do not place an SSC on a sample tube that presents the SSC at
a higher position than the tube that was used to perform the
maximum depth alignment for the SSC. Failure to follow
these instructions can result in operator injury, exposure to
biohazardous samples, or damage to the instrument.
Figure 2-8: SSC Tube
# Description
1 SSC Placed Properly In Tube
2 1 mL
3 Barcoded Draw Tube
2 - 32
Processing Serum or Plasma Samples from SSCs:

1. Fill the SSC with a maximum of 1.0 mL of sample.
Note: The Siemens Sample cup holds a maximum of 1.5 mL of
sample. The dead volume in a Siemens sample cup is 30 µL
only when placed in the same size sample tube that was used
to perform the sample probe maximum depth alignment.
WARNING: Before processing an SSC, ensure that sufficient sample is

present to allow for any automatic test rerun from that SSC. If
certain system options are turned on insufficient sample in a
sample cup may cause erroneous results.
WARNING: Verify on the System Configuration Menu or Process Control

screens whether these options are turned on.
WARNING: Select F6: SYS CONFIG, or F5: PROCESS CTRL >

F8: MORE OPTIONS > F6: HIL SETUP.
2. Place the SSC on a sample tube that presents the SSC at the same height
used in the sample probe maximum depth alignment for SSCs.
3. Tubes that present the SSC at a lower position may be used, but the SSC
must be filled completely. Ensure that sufficient sample is present for the
requested tests.
Processing Whole Blood Samples From SSCs:

1. Pipette the volume of whole blood specified for the sample cup (see the
specific method IFU) into the SSC.
WARNING: Due to whole blood mixing requirements in the SSC, do not

place more or less than the specified volume of sample in the
SSC.
2. Place the SSC on a sample tube that presents the SSC at the same height
used in the sample probe maximum depth alignment for SSCs.
WARNING: To avoid the potential for erroneous results, tubes that

present the SSC at a lower position must not be used for
whole blood samples.
2 - 33
Using Pediatric Tubes

Siemens does not recommend a specific pediatric blood collection tube for use
on the instrument. The tube must be cylindrical at the point where the sample
is aspirated. Any pediatric tube may be used if a proper adapter is available.
Note: SSCs and sample cups are not designed for use in the "PED
tube" mode.
To configure the instrument to use pediatric tubes:
1. Supply an adapter that holds the pediatric tube securely and at a
consistent height to allow the sample probe maximum depth alignment
procedure to be performed properly.
2. Select F6: SYSTEM CONFIG > F4: COMPUTER.
3. Enter the inner diameter of the pediatric tube, and if required designate
PED segments.
4. Perform the sample probe maximum depth alignment using the pediatric
tube and adapter combination that sits the highest in the segment.
5. Always test the pediatric tube configuration before using actual patient
samples in the pediatric tubes.
When using pediatric sample tubes:
• Follow the manufacturer’s recommendations for factors such as tube
storage temperature and orientation, clotting time, spin time, and RPMs.
WARNING: Failure to follow manufacturer’s recommendations for

pediatric sample tube handling could result in erroneous
results or damage to the instrument.
• Always inspect the tube after centrifugation to ensure there is sufficient
sample for the requested tests. Make sure the probe will not penetrate
unusable sample material and that the probe will not go below the
cylindrical area of the tube.
• Remove the stopper.
• Use the appropriate adapter to load the pediatric tube into a segment.
2 - 34
Preparing Samples
Sample Preparation
Ensure the sample is free of clots, fibrin strands, and other impurities that may
affect metering fluids through the instrument before it is loaded into a
segment. There should be no air bubbles in the sample container.
The Dimension EXL System HIL feature can alert for undesirable hemolysis,
icterus and lipemia in a serum or plasma sample; proper preparation is very
important. Follow the sample container manufacturer’s instructions and
specifications on proper storage and handling techniques for mixing, timing,
and centrifugation.
Placing Barcode Labels on Sample Tubes

Place the barcode label on the tube so that:
• It is oriented along the length of the tube. Do not wrap the label
horizontally around the tube.
• It does not overlap the top or bottom of the tube
• There is no slant (or minimal slant) to the label
• There is at least 1/4 inch (6.4 mm) of blank space before and after the
barcode.
Checking for Adequate Sample Volume for Processing

Before loading a sample tube into a segment, use the sample tube fill guide as
a quick check for adequate sample volume.
Hold the sample tube up to the proper side of the guide for that size tube. If
the sample is within the indicated sufficient sample height area, there is
adequate sample volume to run that sample.
Instances where the sample tube fill guide indicates that the sample is out of
reach:
Table 2-15: Sample Out of Reach and Causes
Sample out of reach due to: Solution
A sample tube does not have a barcode on Pipette the fluid into a sample cup before
it or there is less than 1 mL of sample processing
available
Using a barcode on the sample tube and Pipette the fluid into an SSC and place the
there is at least 1 mL of sample available SSC on that same barcoded sample tube.
Place this SSC/tube combination onto a
segment that has been designated for SSC
containers
2 - 35
Figure 2-9: Tube Fill Guide
2 - 36
Entering Sample Data

Use this screen to enter data about a sample. Shortcuts when using this screen
are:
• Manual Query. If the LIS download capability uses the Send ID/Receive
option, use the Manual Query feature to enter sample information. Type
an asterisk (*) in front of the sample number and the rest of the Enter
Sample Data screen will be filled in automatically.
• QC Recall. Enter a unique QC identifier in the Patient Name field beginning
with the letters QC for each QC sample to retrieve all sample information
from the last time that QC sample was processed. However, if a QC panel is
rerun for selected overrange/underrange results, only the tests that were
rerun will be retrieved the next time QC recall is used.
• Default Data. If one mode and/or one fluid type is primarily used, defaults
can be set so that when a blank Enter Sample Data screen appears, those
defaults will display in those fields. See “Entering Sample ID Information”
on page 58 of Chapter 8: Configuration.
1. Select F1: ENTER DATA.
2. Enter information in the following operator-assigned fields:
Table 2-16: Enter Sample Data Field
Field Enter
Position Segment letter and position number of the sample.
Patient Name Information must be entered in one of these two fields.

(and/or Sample Number)
Patient ID Displays only if External Printer mode = Test Results Only and the LIS
Communications mode = OFF.
Tests Use the test keys or panel keys P1–P10.
3. Check the information in the following fields. If necessary, change the

information.
Table 2-17: Changing Sample Data Fields
To change field Use
Mode F7: NEXT MODE
Priority F4: NEXT PRIORITY
Fluid F8: NEXT FLUID
Dilution (if used) Use the arrow keys to move the cursor down to the Location field and then over to
the Dilution field.
Location (if Use the arrow keys to move the cursor to this field.
used)
4. Select F1: NEW SAMPLE to store the sample information.
2 - 37
5. A new Enter Sample Data screen displays with the Position field
automatically updated to the next available position in that segment.
6. Repeat Step 2 through and Step 4 to enter more samples.
Enter Sample Data Screen Fields

Table 2-18: Sample Data Screen Fields
Field Explanation
Position Where the sample container should be placed in the segment.
Mode To choose a different mode, select F7: NEXT MODE to view the type of sample container
used with the sample. Possible modes are:
• Primary Tube • SSC Tube - If Configured

• Barcode Tube • Limited Cup - No Level Sense
• Sample Cup
Fluid To choose a different sample fluid, select F8: NEXT FLUID. There are nine sample fluid
types to choose from: 4 Sample Fluids, and 5 QC Fluids.
Sample Fluids
• Serum • Plasma
• Urine • CSF/Blood
QC Fluids
• SerumQC1 • UrineQC1
• SerumQC2 • UrineQC2
• SerumQC3
When a QC fluid is selected, the Priority field must be QC or XQC. When a urine drugs of
abuse test is selected, the fluid field must be set to Urine.
Note: If position entries indicate none are available, press ALT/S to

display the Segment Status screen. Select F1: SEE ALL to see
the status of positions in each segment. To delete segments
and make positions available for samples, select
F3: DELETE SEG and answer the prompts as they appear. To
delete a segment enter its letter. To delete all on-board
segments enter an asterisk (*). To delete all segments enter
an exclamation point (!).
2 - 38
Table 2-19: Data Screen Fields
Field Explanation
Priority The system automatically sets the priority to Routine. To choose a different priority,
select F4: NEXT PRIORITY.
There are five priorities to choose from:
• Routine • QC
• ASAP • XQC (Crossover QC)
• STAT
When QC or XQC priority is selected, the sample fluid must be set to SerumQC1,
SerumQC2, SerumQC3, UrineQC1 or UrineQC2. If there are two Flex® reagent lots of
the method on board and they have been calibrated, QC will be performed on both
lots.
Volume For reference only. It shows only how many µL of sample are needed to run the tests
requested.
Do not use the volume field to determine the amount of sample needed for
processing.
Dilution Enter a dilution factor in this field if a dilution of the sample was made manually.
Enter the manually made dilution factor as a whole number.
When a dilution factor is entered, that sample will not be autodiluted by the
instrument, except in certain circumstances see “Automatic Dilutions” on page 36 of
Chapter 8. To move the cursor to the Dilution field, move it to the Location field and
press the right arrow key.
Location This is a six character optional field used to indicate types of sample identification
information.
Tests Select tests by pressing a test key or a predefined panel key [P1-P10]. Up to 36 tests
can be ordered for a sample.
2 - 39
Entering and Running Batch Samples

To run batch samples, ensure the Enter Batch Sample Data screen displays. See
“Selecting Instrument Options” on page 3 of Chapter 8: Configuration.
1. Select F1: ENTER DATA.
Note: All batch samples are run with a routine priority.
2. Using the Enter Batch Sample Data screen, enter information in the
following fields:
• Position—segment letter and position number where the
first sample of the batch will be placed.
• Batch ID—the unique identification number for the batch.
• Number of Samples to process—the number of samples in
the batch.
• Tests—use the test keys or panel keys P1–P10.
3. Check the information in the following fields. If necessary, change the
information as shown below.
Table 2-20: Changing Batch Sample Information
To change Use
Mode F6: NEXT MODE
Fluid F8: NEXT FLUID
Note: All remaining sample positions for the batch are assigned
automatically to onboard segments alphabetically and
numerically beginning with the segment position entered in
the Position field.
4. Select F1: ASSIGN POS.
5. Repeat Step 2 through Step 4 to enter more batch samples.
Note: If onboard segments in the segment status area of the screen
are A, X, L, M, then the remaining samples are automatically
assigned to the next available positions in the segment.
6. Select F3: LOAD LIST and use the Load List screen to load samples in
their assigned segment positions.
7. Make a separate handwritten list of patient samples and their positions
on the segment wheel.
8. Select the F4: RUN or RUN.
Note: To add single (non-batch) samples from the Enter Batch
sample Data screen, select F4: ENTER DATA.
2 - 40
Loading Samples
Samples Without Barcode Labels
For samples without barcode labels, use the Load List screen to see the
segment position assigned to each sample.
1. Select F1: ENTER DATA > F3: LOAD LIST.
2. If "New Samples" does not display, select F2: NEXT STATUS.
Note: Load List segment positions: c = Sample Cup, l = Limited Cup -
No Level Sense, t = Sample Tube, x = SSC.
3. Ensure that any lids on sample cups are pressed down and that all
stoppers have been removed from sample tubes
WARNING: Failure to remove stoppers can result in operator injury,

exposure to biohazardous samples, or damage to the
instrument
4. Seat the correct sample container in its correct segment position.

Note: Do not load samples/segments into the sample area if the
instrument is initializing, the moving wheel light is lit, or if
the message "Moving Wheel" is in the photometric sampler
status box.
WARNING: Do not touch the sample wheel area while the instrument is
initializing or processing. It could cause self -injury or damage
to the instrument.
WARNING: Test tubes must be fully seated to the bottom of the adapter.
Do not touch a tube or segment while the instrument is
operating.
Note: Barcode sample tubes will not appear on the Load List screen
until they are located on the instrument. LIS-downloaded,
non-barcoded samples do not appear on the Load List screen
until they are assigned a segment position. See “Processing
Samples Downloaded from an LIS” on page 44 of this chapter
to assign positions.
2 - 41
Samples With Barcode Data

1. For samples with barcode data, position labels so that the barcode is
visible in the opening of the segment and can be read by the barcode
scanner.
Figure 2-10: Barcode Label Positioning
2. Completely seat the segment in its position on the sample wheel. Do not
remove segments when the Moving Wheel Light is on or when the
photometric sampler status box displays Moving Wheel.
WARNING: Incorrect results could occur if a segment is not completely

seated in its segment position.
Figure 2-11: Moving Wheel Light
2 - 42
Processing Samples
When the sample information is available and segments have been loaded into
the sample wheel, begin processing by selecting the appropriate option.
Processing Samples from Standby Status

1. Ensure that all instrument lids are closed and all instrument doors and
panels are closed.
2. Process samples using one of the three options shown below:
a. Press Run on the keyboard.
b. If processing a single sample from the Enter Sample Data screen,
select F2: PROCESS SINGLE.
c. If processing a group of samples from the Load List screen select
F4: RUN.
Adding Samples While the System is in Processing Status

1. Before adding samples while the system is in processing status, check the
segment position in the segment status area of the screen.
a. If there is no segment letter in the position, load a new segment
into that position.
b. If the segment letter has a green background color, add new
samples to empty or unassigned positions of the segment or
remove and replace the segment.
c. If the segment letter has a red background color, add new samples
to empty or unassigned positions of the segment.
WARNING: If the background color is red, do not remove the segment,

move it to another position of the sample wheel, or reposition
any sample containers on the segment.
2. Be sure that the sample data information is available to the instrument.
Sample data information is available if:
•
It is entered using the Enter Sample Data screen.
•
The sample tube is barcoded and its information has been
downloaded to the system.
• The sample tube is barcoded and its information is available
from an LIS.
3. Load the samples/segments into their correct positions.
2 - 43
WARNING: Do not load samples/segments into the sample area if the

instrument is initializing or processing, the moving wheel
light is lit, or the message "Moving Wheel" is in the
photometric sampler status box.
WARNING: Do not touch the sample wheel area while the instrument is
initializing or processing. It could cause self-injury or damage
the instrument.
4. Select Run.
Processing Samples Downloaded from an LIS

Samples that have had their sample information downloaded to the
Dimension EXL system from an LIS will be run:
• For barcoded sample tubes, when the instrument reads the barcode during
its scan of the sample segments.
• For non-barcoded sample tubes, after the operator assigns a position for
those samples.
Configuring the System to Process Downloaded

Samples from an LIS
To run samples downloaded from an LIS, both Communications Set Up and
Sample ID/Computer Menu should have their fields filled out as shown in the
table below. With the screens and fields filled in, use the Sample Status screen
to assign segment positions for any downloaded samples that are not
barcoded.
Note: If there is an LIS, laboratory specific system configurations
have already been set during installation to meet any
necessary requirements. Do not change instrument options
or configuration settings without approval from a laboratory
supervisor.
Table 2-21: Download Samples from an LIS
Screen Navigation Field Set field to
Communications F6: SYSTEM CONFIG > Mode Send ID/Receive

Set Up F4: COMPUTER > F4: (or Send/Receive)
COMUNICATIONS
Sample ID/ F6: SYSTEM CONFIG > F4: Sample Sample cup (or to the
Computer Menu COMPUTER Edit type of sample container
used most frequently).
2 - 44
Processing Non-Barcoded Samples Downloaded from an LIS

Note: All downloaded samples appear at the top of the Sample
Status screen with double asterisks (**) in the Position field.
1. From the Sample Status screen, select F2: NEXT STATUS to change the
status to “ENTERED”.
2. Move the cursor to any sample with double asterisks (**). To see the
tests requested for that sample, select F1: SHOW TESTS.
Note: The cursor will not change into a box if the Sample Edit field
on the Sample ID/Computer Menu screen is set to No Default.
Change the setting on this screen to Primary Tube or Sample
Cup (the type of container used most frequently).
3. Enter a segment position for the sample.
4. Select the ENTER key.
5. Load the proper sample container into the segment and position that
was assigned.
Note: If the sample container being used is not the same as what is
configured in this field, use F4: EDIT/RERUN to change the
mode field to the actual sample container for the sample.
WARNING: Failure to use the proper sample container can result in

operator injury, exposure to biohazardous samples, or
damage to the instrument.
WARNING:
6. Repeat Step 2 through Step 5 until all required asterisked (**) samples
have been assigned positions and loaded.
7. Select Run.
2 - 45
Determining the Status of Samples

The Sample Status program checks the progress of samples through the
instrument. There are several ways to determine the status of samples and
their segments:
• Sample Status Screen
• Sample Status Completion Time
• STAT Status Alert Key
• Sample Alert Key
• Segment Status - On Board Segments screen
• Segment Status - All segments screen
Viewing Sample Status

Sample Status Screen
The Sample Status screen contains the last 500 sample requests entered into
instrument memory. After is it entered, a sample will remain on this screen
until it is automatically discarded when either 500-sample or 5000-test result
limit is exceeded.
A search function is available from this screen to help locate specific samples
quickly see “Searching for a Sample” on page 8 of Chapter 3.
If there is more than one page of samples use the following options to
navigate:
• Use the up and down arrow keys to move through the list.
• Use F5 or F6 to move to the first or last page of the list.
• Use PgUp and PgDn keys on the keypad to move forward or back in the list
one screen at a time.
Note: To determine the assay results for a sample, move the cursor
to the sample and select F8: TEST RESULTS.
Note: If there is an asterisk (*) present to the left of the status
column, at least one assay on the sample had a test report
message on its printout.
2 - 46
To Determine what tests were run on a sample:

1. Move the cursor to the sample.
2. Select F1: SHOW TESTS. A list of the assays displays in the message area.
If this list ends with a series of dots, select F8: TEST RESULTS to see all assays
for the sample.
Ensure that the sample status category displays in the brackets in the upper
right-hand corner of the screen.
If this is not the appropriate status category, select F2: NEXT STATUS until the
required status category displays.
Table 2-22: Sample Status Table
Status Meaning
Entered This sample’s data has been entered into a Load List, but the operator has not
requested the system to run this sample yet.
Ready This samples data has been entered into a Load List, the sample has been loaded into
the sample area, and the operator has requested the system to run this sample.
Begun The system has begun to process tests for the sample; some test results may be
available.
Done All tests for the sample have been processed; all test results are available.
Printed All tests for the sample have been processed; all test results have been sent to the
printer.
Report All tests for the sample have been processed; all test results have been sent to an
external host computer.
All This is a comprehensive list of all samples currently in instrument memory.
Sample Status Completion Time

To show the completion time for all samples,
1. Select F2: SAMPLE STATUS > F7: COMPLETN TIME.
2. Select F3: NXT DSPLY MODE to toggle between the following display
modes: Show All, Show STAT, Show Completed, and Show Processing.
3. Select F4: SORT BY NAME to sort by Name, ID, or Time.
2 - 47
STAT Status Alert Key

The STAT Status alert key can be configured to change to red or yellow to alert
to a specific situation (see Chapter 8: Configuring the STAT Status Alert Key).
When the key on the touchscreen is selected, the STAT Samples screen is
displayed.
The information that is displayed in the “Sample Available In” field depends on
the status of the sample:
Table 2-23: Sample Available Field
Status of Sample When Sample Available In field displays
Processing is completed Now
Currently processing Time to completion
Entered but not yet processing Not Started (if alert is active)
Entered (if alert is not active)
There are four display modes for the STAT Samples screen, depending on the
configuration. See “Configuring the STAT Status Alert Key” on page 48 of
Chapter 8: Configuration.
To change the display, select F3: Next Display.
Table 2-24: Sample Field Modes
Mode Displays
Show All Displays all STAT samples, regardless of status.
Show Completed Displays all completed STAT samples.
Show Processing Displays all STAT samples currently processing. The When
Available field is updated every five seconds. When a sample is
completed, it is removed from this list.
STATS Not Started Displays STAT samples entered but not started within a specified
time period.
2 - 48
Additional function keys on the STAT Samples screen can save time by
displaying screens to research and resolve errors. To use the following function
keys, first move the cursor to an individual sample.
Table 2-25: STAT Sample Fields
Function Key Purpose
F1: TEST RESULTS Displays the Test Results screen. For additional information, see
"Displaying Test Results" later in this section.
F2: EDIT/RERUN Displays the Enter Sample Data screen. For more information, see
"Editing and Rerunning a Sample" later in this section.
F5: CLEAR ALERT Removes the yellow or red alert status from the selected sample and
the stat key.
F8: COMPLETE ALERT When processing is complete for the highlighted sample, the alert is
activated.
Sample Alert Key

The Sample Alert key changes color to yellow when a test is being reprocessed
for any of these reasons:
Table 2-26: Sample Alert Status Reasons
Autodilute Panic Repeat
Reflex Test Process Error
Select the Sample Alert key to display the Sample Alert screen. Samples appear
on the screen at the time the initial test is completed and are removed after
the rerun is completed. The display is refreshed every 10 seconds.
While the sample is displayed, select it with the cursor and select F1: TEST
RESULTS to see the detail (see “Displaying Test Results” on page 7 of Chapter
3).
Table 2-27: Sample Results Field Terms
Field Information
Patient Name Name of patient associated with the sample.
Sample ID ID from barcode label or Enter Sample Data screen.
Position Segment position of the sample.
Reason for Rerunning Possibilities are:

- Auto Dilute - Panic Repeat
- Reflex - Process Error
Meth The assay that is being rerun or reflexed for the sample.
Samp Available In Time remaining until sample is finished processing. Expressed

in minutes and seconds or as READY.
2 - 49
Segment Status – On Board Segments

The position assignments status of segments can be viewed by pressing ALT/S
or selecting F8: SEGMENT STATUS from the Operating Menu.
The On Board Segments screen shows each segment position and the sample
ID of the sample that is assigned to that position. The segment ID uses the
information in the sample number field from the sample’s Enter Sample Data
screen.
Note: To toggle between the On Board Segments and the All
Segments screens, press the F1 function key.
Segment Status – All Segments

View the processing status of segment positions for all segments by pressing
ALT/S and then selecting F1: SEE ALL.
Viewing Segment Status

Use the Segment Status - On Board Segments screen to view the position
assignments status of the segments displaying in the Segment Status area of
the screen. Press ALT/S to see this screen.
The On Board Segments screen shows each segment position and the sample
ID of the sample that is assigned to that position. The segment ID column uses
the information in the sample number field from the sample’s Enter Sample
Data screen.
Press the Alt/S key combination on the keyboard.
Note: If "No Data" displays in a field, there is no data available in
system memory or from the LIS for the sample.
Note: Select F3: DELETE SEG to delete or clear segments that have
been programmed manually. Delete a segment by entering
its letter, and all on-board segments by entering an asterisk
(*), all segments by entering an exclamation point (!).
Note: Select F4: DELETE SAMPLE and follow message prompts as
they appear to delete individual samples from a segment.
Note: Do not press Function Keys F7: DELETE ENTERED, or
F8: DEL. RECORDS unless directed to do so.
2 - 50
Use the Segment Status - All Segments screen to view the processing status of
segment positions for all segments. From the Segment Status - On Board
Segments screen, select F1: SEE ALL to view this screen. Use this screen when
pre-entering samples into segments that are not currently on the instrument,
or when the availability of segment positions is unknown.
Table 2-28: Letters and Colors Used for Sample Status
Letter Description Color
N No Data Red
E Entered White
R Ready Green
B Begun Yellow
D Done Light Red
P Printed Blue
r Reported Light Blue
2 - 51
Reaction Vessel Status

The status of each of the 45 slots in the HM incubate wheel is available from
the Process Control Menu. To see the status of each slot in the incubate wheel:
1. Select F5: PROCESS CTRL > F8: MORE OPTIONS > F3: SHOW VSL MAP.
2. Select EXIT to go back to the Process Control Menu screen.
3. The status of the slots in the incubate wheel is now shown whenever this
screen appears.
Note: See the next page for a discussion on how to use these
locator marks. The letters indicate the status of the 45
positions on the incubate wheel.
Table 2-29: Incubate Wheel Letters and Status Explanation
Letter Indication Explanation
U Unloaded No vessel is loaded or slot empty.
L Loaded Vessel has been successfully loaded.
A Allocated Vessel has been allocated by system for use.
i incubating Vessel contains sample/reagent and is incubating.
w washing Vessel is on the wash wheel.
W Washed Vessel has returned from wash wheel to incubate wheel.
P Processed Assay complete, vessel has been used and will be discarded.
t transferred Vessel has been transferred to the LOCI chamber.
The dot on the screen above status position 1 and the line above position 23
correspond to the white alignment dot and the white alignment mark on the
incubate wheel itself. If there is a vessel listed on this screen that needs to be
located, use these reference points and refer to the illustration below.
2 - 52
Figure 2-12: Incubate Wheel Position
# Description
1 White Alignment Mark
2 White Alignment Dot
2 - 53
2 - 54
Dimension EXL with LM/EXL 200 System Operator’s Guide Sample Reports
Chapter 3: Sample Reports
3-1
Sample Reports Dimension EXL with LM/EXL 200 System Operator’s Guide
Understanding Test Results

Reporting Test Results
The operator can report a test result if it displays without a message on its line
of the printed test report. If a message displays, see the information below.
Test Results with Test Report Messages

A test result may display with a test report message next to the result in the
Reference Range column.
WARNING: Do not report the result of a printed test report whose

meaning indicates that it is non reportable, even though the
result may display on the printed report slip.
A test result line on the test report can display only one test report message. If
more than one message has affected the result, the system prints the highest
priority message. See “Test Report Message Priorities” on page 29. See Test
Report Messages on page 15 of this Chapter for an alphabetical listing of all the
test report messages along with the appropriate operator action.
Test Results with Reference Range Indicators

A test result may have a reference range indicator next to it. The four reference
range indicators are: HI, LO, hp, and lp. Test results that display with a
reference range indicator only are reportable.
WARNING: Do not report the result of a printed test report whose

meaning indicates that it is non reportable, even though the
result may display on the printed report slip.
These reference range indicators display next to a result according to the
ranges the laboratory has programmed for that method in the Method
Parameters screen. See “Entering User-Defined Method Parameters” on
page 90 of Chapter 8: Configuration. Remember to follow laboratory
procedures for lp and hp indicators.
HIL Index
The HIL index alerts for potential interference from hemolysis, icterus, and
lipemia in a sample, where:
• H = hemoglobin resulting from lysis of red blood cells
• I = icterus resulting from endogenous bilirubin
• L = lipemia or turbidity caused by insoluble lipids
3-2
When the HIL feature has been programmed (See “HIL Feature” on page 44 of
Chapter 8: Configuration), the instrument automatically pipets 20 µL of
sample into an empty cuvette along with system water. Spectral absorbance
measurements are used to generate a sample-specific HIL index. The HIL index
displays on the report slip as a three-digit value where:
• 1st digit = H index
• 2nd digit = I index
• 3rd digit = L index
Each index value correlates to an approximate concentration for each of the
potential interferents, as specified in this table:
Table 3-1: Concentration of Potential Interferents
H I L
Hemoglobin Bilirubin Intralipid ™
Index (mg/dL) (mg/dL) (mg/dL)
1 H ≤ 25 I ≤ 2 L ≤ 25
2 25 < H ≤ 50 2<I ≤ 5 25 < L ≤ 50
3 50 < H ≤ 200 5 < I ≤ 20 50 < L ≤ 200
4 200 < H ≤ 300 20 < I ≤ 40 200 < L ≤ 600
5 300 < H ≤ 500 40 < I ≤ 60 600 < L ≤ 1000
6 500 < H ≤ 1000 60 < I ≤ 80 1000 < L ≤ 3000
If the following conditions are met, the test report displays the “HIL Interf”
message next to the affected test result:
• The HIL Operating Mode has been set to an “AUTO-ON” mode.
• A method with entered Alert Index values between 2 and 6 has been
processed on the sample.
• Any of the measured HIL index values (H, I or L) is greater than or equal to
the corresponding Alert Index value entered for that method.
If the “HIL Interf” message is displayed, follow laboratory procedures for
reporting results when the sample is hemolyzed, icteric and/or lipemic.
If the maximum number of tests (36) has been ordered for a sample, HIL is not
processed.
3-3
Clot Check
A test result with a "ClotCheckErr" report message will not include a numerical
result. Any successfully completed test results from the same sample cup will
be displayed. Any tests that have not yet aspirated sample from the same
sample cup will be aborted, and have an "Aborted Test" message associated
with them.
Figure 3-1: Test Report
3-4
Printed Test Report

The printed test report is automatically output by the printer when all the
requested tests on a sample have been processed. If an instrument problem
occurs during the processing of a assay, the test report shows an appropriate
message for each test that was affected.
If two or more of the same assays are requested or performed on a sample, the
mean, sd, and cv for these tests are displayed at the bottom of the test report.
The following formulas are used to calculate the standard deviation and the
coefficient of variation for these tests:
Figure 3-2: Test Report Equation
3-5
Figure 3-3: Printed Test Report
The order for listing test results is configurable. Test results can be printed and
displayed on the screen in the order they were processed or a customized
order. See “Selecting a Test Result Order” on page 75 of Chapter 8:
Configuration.
Note: If connecting an external printer to the instrument, test

reports can be printed on either the external printer or the
instrument’s printer. In addition, the external printer test
report for the laboratory can be customized. Refer to the
“Configuring the Printer” and “Customizing an External Printer
Report” procedures in Chapter 9.
3-6
The top header of the system printer’s test report can be customized with a
laboratory name. See “Configuring the Printer” on page 51 of Chapter 8:
Configuration.
Table 3-2: Test Report
Test Description
HIL Indicates the three indices for HIL measurement in the sample.
CA This indicates that two CA tests were requested and run on this sample.
CREA These lowercase letters indicate that this method’s standard sample volume
was changed on the Method Parameters screen or the method was correlated.
See “Entering Method Parameters” on page 33 of Chapter 8: Configuration.
MG The result exceeded the assay range of the method. Although a result appears
with an "HI" test report message, it cannot be reported because of the "assay
range" non-reportable test report message.
VANC The result was above the assay range of the method and could not be
calculated. No result is reported with the "above asy rng" non-reportable test
report message.
CA The last line was automatically calculated by the instrument because more
than one CA test was run on the sample.
Displaying Test Results

1. Select F3: TEST RESULTS.
2. Type the patient name or sample number and select ENTER.
3. The most recently processed sample with that patient name or sample
number displays.
4. Select F1: SEARCH BACK to search for a sample processed prior to the
sample or F2: SEARCH FORWARD to search for one processed after the
sample.
Note: The results can be printed out in the order they were
processed in (referred to as "sample order") or in a
customized order (referred to as "selected order").
5. Select F7: SMP ORD ON/OFF and answer the prompt to see the
difference between a sample order sequence and a processed order
sequence for these assay results.
Reprinting Results from the Test Results Screen

1. Select F5: PRINT RESULTS to reprint the results.
Note: If the results have already been sent to a host computer, the
following message displays: Do you want to retransmit to
Host Computer (y/n).
Note: Before using the retransmit feature, ensure that the host
computer is capable of receiving multiple reports for the
same sample without creating a problem.
3-7
2. Select N to print out the results; select Y to retransmit to the host

computer.
Note: A reprinted report displays Print Results on it. The original
report displays Test Report.
Searching for a Sample

1. Select F2: SAMPLE STATUS.
2. Using the Sample Status screen, check that the sample status category to
be searched is in the brackets in the upper right-hand corner of the
screen. To search through a different status category, select F2: NEXT
STATUS.
Note: An asterisk (*) next to the sample on the Sample Status
screen indicates that the sample had one or more failed
assays.
3. Select F3: SEARCH.
Note: Type the required search pattern for the patient name or
sample number of the sample.
4. Select ENTER.
Note: The Test Results screen for the most recently processed
sample matching the search pattern displays.
5. Select F1: SEARCH BACK to see if any more matches were found for the
search pattern entered.
Note: To search for samples in another way, from the Operating
Menu Select: F3: TEST RESULTS > F6: SEARCH and follow the
procedure from Step 3.
3-8
Search Examples
Table 3-3: Search Examples
Search Result
John Smith Samples that match John Smith exactly.

It would not find: John Smith-123, A-John Smith.
Smith-Jackson Samples that match Smith exactly.

Punctuation marks are not recognized.
*Smith Samples that end with Smith. It would find: John Smith, 123-
Smith.
It would not find: John Smith-123, Smith-Jones.
Smith* Samples that begin with Smith.

It would find: Smith-Jones, Smith-123-A.
It would not find: John Smith-123, 123-Smith.
*Smith* All samples that have the word Smith in it.

It would find: John Smith-123, ICU Smith-A, John Smith, Smith-
Jones.
123* All sample ID numbers that begin with 123.

It would find: 123456, 123333, 123999, 123957.
123**9 Numbers that begin with 123, end with 9, and have two characters
between the 3 and 9.
It would find: 123649, 123AZ9, 123GB9, 1235W9.
Using an Asterisk (*) in the Search Pattern

The * is a match for anything.
In the example *Smith, anything can precede the word Smith. In the example
Smith*, anything can follow the word Smith. In the example *Smith*,
anything can precede or follow Smith.
3-9
Editing and Rerunning a Sample

1. To find the Enter Sample Data screen for the sample use one of the three
screens listed below:
Table 3-4: Screens
Screen Action
Load List Press Alt/L to display the Load List and select F2: NEXT STATUS to
access all. If the sample is still on the Load List, move the cursor to
the sample and select F8: EDIT SAMPLE.
Sample Status 1. Select F2: NEXT STATUS until the status category in the upper
right corner of the display changes to the status category of the
sample, if known or All.
2. Find the sample in this list by either moving the cursor to the
sample using the arrow keys or by selecting F3: SEARCH and
entering the required search pattern
Test Results Enter the required search pattern.

Once the sample has been located, select F4: EDIT/RERUN.
2. The Enter Sample Data screen or the Add Tests screen will display.
Change or add information.
3. After editing the information:
a. Select F2: PROCESS SINGLE or select RUN to begin processing the
sample.
b. Select F3: LOAD LIST to enter the sample into the Load List.
c. Select F4: RUN or select RUN to begin processing all samples
shown on the Load List.
4. Select F1: NEW SAMPLE to enter a new sample.
Note: If the status of the sample to be edited is Begun, the Add
Tests screen appears and changing the sample’s priority or
adding new tests are the only available options. The sample’s
container cannot be changed until it finishes processing.
3 - 10
Rerunning Assays Using Load Errors

Note: Do not remove any segments or sample containers from their
original positions. Do not delete any segments using the
software.
1. Review the Test Report slip and correct any instrument problems that
might have caused a message.
2. Press ALT+L.
3. Select F2: NEXT STATUS.
4. Select F6: LOAD ERRORS.
5. Respond to the prompt that appears: Designate the segment(s) with
error samples to be added to the Load List.
Table 3-5: Segments
Segment Selection
Segment letter Any samples with errors on that segment.
* Any segment currently appearing in the segment status box that has
samples with errors on it.
! All segments on the Load List
6. Respond to the next prompt by typing a Y.

7. Select what to do next:
a. To rerun the tests now, select F4: RUN.
b. To enter new samples, go to the Enter Sample Data screen.
Note: If the prompt is responded to with an “n”, the number of tests
in the selected area are displayed but cannot be loaded at
this time.
Rerunning Assays Using Edit Sample (Clot Check Errors)

Before rerunning the sample, ensure the sample is free of particulate matter,
fibrin, or clots.
1. Press ALT+M for troubleshooting steps.
2. Press ALT+L and select F2: NEXT STATUS.
3. Place the cursor on the sample to be edited on the Load List screen.
4. From the Load List screen select F8: EDIT SAMPLE.
5. Selecting F8: EDIT SAMPLE will display the Enter Sample Data screen
with all original assays displayed.
6. After editing the sample, select F2: PROCESS SINGLE or F3: LOAD LIST
to return to the Load List screen.
3 - 11
Priority of Load List Screen Errors

Table 3-6: Load List Screen Errors
Error Type Status Message
Short Sample Error and Clot Check Error on load "Short Sample"
list
Short Sample Error and no Clot Check Error on "Short Sample"

load list
No Short Sample Error and a Clot Check Error on "Clot Check Error"
load list
No Short Sample Error and no Clot Check Error on "Short Sample"

load list
3 - 12
Sample Troubleshooting
Resolving a Short Sample Detected
When the short sample icon displays, the instrument sounds the alarm and
displays the error message “No Sample Found During Level Sense”. This
indicates that there is not enough sample in the sample container to perform
all the assays requested. Choose from the following options:
• Add more of the same sample to the sample container.
• Reduce the number of assays on the sample using F8: EDIT SAMPLE.
• Transfer the sample into a different sample container using the procedures
below.
1. Press ALT+L to display the Load List screen.
2. View the list of samples that do not have enough fluid to perform the
requested assays.
Sample container letter designations on the Load List screen are:
a. t = sample tube
b. c = sample cup
c. x = SSC
d. p = pediatric tube
e. l = limited cup - no level sense
Table 3-7: Sample Container Procedures
Sample Container Procedure
Tube (with bar code) Short Sample – Primary Tube with a barcode
Tube (no bar code) Short Sample – Primary Tube without a barcode
Sample Cup Short Sample – Sample Cup
SSC Short Sample – SSC
Pediatric Tube Short-Sample- Primary Tube without a barcode
3 - 13
Short Sample - Primary Tube with a Barcode

When a short sample occurs in a primary tube with a barcode label, transfer
the sample into an SSC or a sample cup depending on the amount of sample
available. If transferring to a sample cup, follow the instructions below.
The dead volume in a Siemens SSC is 30 µL only in the sample tube that was
used to perform the sample probe maximum depth alignment for an SSC.
Tubes that present the SSC at a lower position may be used but must be filled
with 1.0 mL of sample.
1. Select PAUSE.
2. Remove the barcoded tube from its segment position. Use a pipette to
transfer the sample into an SSC.
3. Place the SSC on top of the same barcoded tube. Place it in the same
segment position on the same sample segment.
WARNING: Failure to place the SSC/barcoded sample tube combination

into the same segment position as the original sample will
cause erroneous patient identification and erroneous results.
4. Select PAUSE.
5. Using the Load List short sample screen, move the cursor to the short
sample. Select F6: CHANGE TO SSC, and answer the prompt by typing a
Y.
6. After all of the short samples are resolved, press Reset to clear the short
sample error message from the screen.
Short Sample – Primary Tube without a Barcode

When a short sample occurs in a primary tube without a barcode label, transfer
the sample into a sample cup or an SSC depending on the amount of sample
available.
1. Select PAUSE.
2. Remove the sample tube from its segment position and use a pipette to
transfer the sample into a sample cup.
3. Place the sample cup directly on top of the adapter in the same segment
position on the sample segment.
WARNING: Failure to place the sample cup into the same segment
position that the sample tube was in will cause erroneous
patient identification and erroneous results.
4. Select PAUSE.
5. From the Load List short sample screen, move the cursor to the short
sample.
6. Select F8: EDIT SAMPLE to display the sample’s Enter Sample Data
screen.
7. Select F7: NEXT MODE until the Mode field changes to "sample cup".
8. Select F2: PROCESS SINGLE.
3 - 14
Short Sample – SSC

When a short sample occurs in an SSC, transfer the sample into a sample cup.
1. Select PAUSE.
2. Remove the sample tube from its segment position. Use a pipette to
transfer the sample into a sample cup.
3. Place the sample cup directly on top of the adapter in the same segment
position on the sample segment.
WARNING: Failure to place the sample cup into the same segment
position that the sample tube was in will cause erroneous
patient identification and erroneous results.
4. Select PAUSE.
5. Move the cursor to the short sample.
6. Select F8: EDIT SAMPLE to go to the sample’s Enter Sample Data screen.
7. Select F7: NEXT MODE until the Mode field changes to "sample cup".
8. Select F2: PROCESS SINGLE.
Short Sample – Sample Cup

When a short sample occurs in a sample cup, change the sample container
type for the sample to a limited cup.
Note: Ensure that some sample remains in the sample cup after the
sample is run.
1. From the Load List short sample screen, move the cursor to the short
sample.
2. Select F7: NO LEVEL/CUP. Answer the prompt by typing a Y.
3. After the sample has been run, there must be some sample fluid
remaining in the sample cup.
If there is no sample in the sample cup after processing is complete, review
assay results carefully to decide which are reportable.
Note: When running the Limited Cup- No Level Sense mode, run
one test per sample request and check the volume of sample
in the cup after each assay.To determine which assays were
processed first, view the assay results in their sampled order
sequence. Display the Test Results screen for that sample and
select F7: SMP ORD ON/OFF. At the prompt enter Y to list the
assay results by sample sequence. Tests at the top of this
screen were processed first.
3 - 15
Test Report Messages and Reference Range Indicators
Assay Results with Test Report Messages

An assay result on the printed test report may have a test report message in
the Reference Range column of the printout. Depending on the specific test
report message, the assay result may or may not be reportable.
WARNING: Do not report an assay result that appears on the printed

report with a message indicating that the result is NON-
REPORTABLE.
An assay result line on the test report can display only one test report message.
If more than one test report message has affected the result, the instrument
prints the highest priority message. See “Test Report Message Priorities” on
page 29 of this Chapter.
Assay Results with Reference Range Indicators

An assay result on the printed test report may contain a reference range
indicator next to the result. There are four reference range indicators: HI, LO,
hp, and lp. Assay results that appear with only a reference range indicator are
reportable.
WARNING: Do not report an assay result that appears on the printed test
report with a reference range indicator if it also appears with
a test report message indicating that the result is NON-
REPORTABLE.
These reference range indicators appear next to a result according to the
ranges that are programmed for that assay in the Method Parameters screen.
See “Entering User-Defined Method Parameters” on page 90 of Chapter 8:
Configuration. Remember to follow laboratory procedures for lp and hp
indicators.
3 - 16
Understanding Test Report Messages

Abnormal Assay (abnl assay)
Explanation:
For photometric methods, the Abnormal Assay message indicates that the
expected absorbance was not met for a specific cuvette. For chemiluminescent
(LOCI) methods, the Abnormal assay message indicates that expected K counts
were not met for a specific LOCI test.
What to Do:
This result cannot be reported. Rerun the sample. If the same message
appears:
1. Run a QC sample for that assay.
a. If the error does not reoccur for this QC sample, contact the
Customer Care Center - Technical Solution: Inside U.S.: 1-800-441-
9250; Outside U.S. Refer to the local support team.
b. If the error reoccurs, remove and confirm the removal of the Flex
reagent cartridge for the assay. Then add that same reagent
cartridge back into the instrument. If the instrument will not accept
it, obtain and add a new Flex reagent cartridge.
2. Rerun the sample. If the message reoccurs, contact the Customer Center
- Technical Support: Inside U.S.: 1-800-441-9250; Outside U.S. Refer to
the local support team.
Abnormal Reaction (abnl reaction)

Explanation:
For non-HM assays:
An abnormal condition (foaming, air bubbles, or turbidity) occurred in the
reaction mixture in the cuvette.
For HM assays:
Absorbance readings are taken to ensure that the reaction is completely
transferred from the HM module to the cuvette and that there is no system
contamination of reagents.
For LOCI assays:
A sample produced a signal significantly lower than the lowest calibrator (on
an inverse curve such as the FT4L assay, this indicates a signal lower than the
highest calibrator). The flag means that there is a chance that the sample
either has an interferrent, the reaction did not receive the required reagents or
the patient sample is actually recovering far below normal samples.
3 - 17
What to Do:
For non-HM assays:
This result cannot be reported. Align the sample and reagent probes, and then
rerun the sample.
For HM assays:
This result cannot be reported. If the sample is fibrinated, centrifuge the
sample and rerun. If the sample is not fibrinated or the error persists, contact
the Customer Care Center - Technical Solution: Inside U.S.: 1-800-441-9250;
Outside U.S. Refer to the local support team.
For LOCI assays:
This result cannot be reported:
If multiple samples are sequentially reporting with this flag, do not report any
results and please call Customer Care Center - Technical Solution as the results
require further investigation by Siemens personnel.
If only one flagged result is seen:
Verify the system operation by repeating the sample with fresh Quality Control
samples.
If the abnormal reaction on the sample persists and the Quality Control is
within expected limits, dilute the sample 1:2 with a patient/QC sample with a
known value as described in the section “Mixture of a Sample and a Known
Standard” .
If the abnormal reaction flag persists, the result should not be reported and the
specimen should be analyzed by an alternate method. Please contact the
Customer Care Center - Technical Solution in the event this occurs.
Aborted Test
Explanation:
An action by either the operator or instrument aborted this assay.
What to Do:
Rerun the assay.
Absorbance
Explanation:
The MAU at the measurement wavelength exceeded 2000.
What to Do:
Rerun the sample. If the error occurs on the rerun, it may be due to optical
interference.
3 - 18
Above Assay Range (above asy rng)

Explanation:
The result is above the assay range and cannot be calculated
What to Do:
Check the assay IFU to determine if the sample can be diluted. If yes, manually
dilute the sample and rerun the assay. Make the smallest dilution possible to
bring the result down into the assay range. Enter the dilution factor as a whole
number on the Enter Sample Data screen and the instrument will multiply the
result by this factor.
Antigen Excess (antign excess)

Explanation:
The result is extremely high for that assay.
What to Do:
dilute the sample and rerun the test. Make the smallest dilution possible to
result by this factor. See “Dilution of a Sample” on page 27 of this Chapter.
Arithmetic
Explanation:
This error is associated with nonlinear (logit) assays only. This error occurred in
result calculations because the change in absorbance was less than the C0 or
greater than C0 + C1.
What to Do:
If on a patient sample, the concentration is either very high or very low. Rerun
the sample or contact the Customer Care Center - Technical Solution: Inside
U.S.:
1-800-441-9250; Outside U.S. Refer to the local support team. If QC has also
shifted low, change the R2 reagent pump 2500 µL syringe, cancel the well in
use and prepare new reagent.
3 - 19
Assay Range
Explanation:
The result is above or below the assay range listed in Method Parameters on
the instrument. Can be either low or high.
What to Do:
If the result is LOW, analyte values may be depressed below the assay range
because the patient sample has very little or no concentration of the analyte,
insufficient sample, is falsely depressed because of interfering substances, or
there was an instrument system failure. Each laboratory should establish its
own protocol for addressing the "Below Assay" test report message before
reporting the result as less than the established clinical reportable range. The
procedure should check:
• The sample container has sufficient usable sample for the assays ordered.
• The sample container was placed in the appropriate segment and cup
position.
• Verify instrument function.
If no obvious reason for the low analyte result is found, or the result is
inconsistent with the available clinical information and prior assays, confirm
the accuracy of the result with additional testing such as:
• If the result is a negative number, perform a 50% recovery of a known
standard or QC material to confirm that there was no activity in the sample,
that there was enough sample volume used by the instrument, and that
there was no system malfunction. See “50% Recovery of a Known Standard
Using a Sample” on page 28 of this Chapter.
• If the result is below the reportable assay range, prepare and run a mixture
of the sample with a known standard or QC material to confirm that there
was low activity in the sample below the assay range, that there was
enough sample volume used by the instrument, and that there was no
system malfunction. See “50% Recovery of a Known Standard Using a
Sample” on page 28 of this Chapter.
If the result is HIGH, check the assay IFU to determine if the sample can be
diluted. If yes, manually dilute the sample (see IFU for recommended diluent)
and rerun the test. Make the smallest dilution possible to bring the result down
into the assay range. Enter the dilution factor as a whole number on the Enter
Sample Data screen and the instrument will multiply the result by this factor.
See “Dilution of a Sample” on page 27 in this Chapter.
3 - 20
Assay Range Diluted (assy rng/dilu)

Explanation:
Assay result exceeded the assay range, The sample was then autodiluted and
rerun. The result of the rerun still exceeded the assay range.
What to Do:
dilute the sample and rerun the assay. Make the smallest dilution possible to
result by this factor.
Below Assay Range (below asy rng)

Explanation:
The result is below the assay range and cannot be calculated.
What to Do:
Analyte values may be depressed below the assay range because the patient
sample has very little or no concentration of the analyte, insufficient sample, is
falsely depressed because of interfering substances, or there was an
instrument system failure. Each laboratory should establish its own protocol
for addressing the "Below Assay" test report message before reporting the
result as less than the established clinical reportable range. The procedure
should check:
• The sample container has sufficient usable sample for the tests ordered
• The sample container was placed in the appropriate segment and cup
position
• Verify instrument function
If no obvious reason for the low analyte result is found, or the result is
inconsistent with the available clinical information and prior assay, confirm the
accuracy of the result with additional testing such as:
• Perform a 50% recovery of a known standard or QC material to confirm
that there was no activity in the sample, that there was enough sample
volume used by the instrument, and that there was no system
malfunction. See “50% Recovery of a Known Standard Using a Sample” on
page 28 of this Chapter.
Calibration Expired (calib’n exp’d)

Explanation:
The calibration or verification for this assay/lot is expired.
What to Do:
Recalibrate/reverify the assay lot number.
3 - 21
Clot Check Err

Explanation:
Any successfully completed test results from the same sample cup will be
displayed. Any tests that have not yet aspirated sample from the same sample
cup will be aborted and will have an "Aborted Test" message associated with
them.
What to Do:
For all clot check errors follow the Alt/M troubleshooting steps in the
Dimension EXL software. See “Clot Check Bypass” on page 16 of Chapter 7
Troubleshooting.
Diluted
Explanation:
The test has been autodiluted.
What to Do:
If the assay result is printed, the assay range was not exceeded and the result
may be reported.
If no assay result is printed, the result did exceed the assay range. Do the
following:
• Ensure that sufficient sample volume was available in the sample
container.
• Verify the sample quality (fibrin, air bubbles, etc.).
• Rerun the test.
Hemoglobin (TBI and DBI)

Explanation:
When this message appears with the DBI result, it indicates a hemoglobin
concentration greater than 50 mg/dL and will lower the DBI result for that
sample.
What to Do:
Follow laboratory’procedures for reporting results when the sample is
hemolyzed.
Explanation:
When this message appears with the TBI result, it indicates a hemoglobin
concentration greater than 1000 mg/dL and will lower the TBI result for that
sample.
What to Do:
Follow laboratory procedures for reporting results when the sample is
hemolyzed.
3 - 22
HI
Explanation:
Result is higher than the reference interval.
What to Do:
Result may be reported.
High ‘A’ Error (hig ‘A’ err)

Explanation:
The absorbance at the measurement wavelength was higher that the limit set
in the system software for that assay.
What to Do:
Urine drugs of abuse assays should be centrifuged and rerun. For other assays,
manually dilute the sample and rerun the assay. Make the smallest dilution
possible to bring the result down into the assay range. Enter the dilution factor
as a whole number on the Enter Sample Data screen and the instrument will
multiply the result by this factor.
For UCFP:
During calibration of the UCFP method, the high ‘A’ error may be observed on
the level 5 calibration. This error for UCFP does not affect the proper assay
calibration and may be disregarded. Successful calibration can be verified
using quality control materials.
Explanation:
Autodilution was not performed.
What to Do:
If the system is set up to perform automatic dilutions, refer to “Automatic
Dilutions” in the Customizing section for possible reasons why autodilution
was not performed.
HIL Interf
Explanation:
One or more of the HIL indexes for the assay is equal to or greater than the HIL
Alert Index entered during HIL Setup.
What to Do:
Follow laboratory procedures for reporting results when the sample is
hemolyzed, icteric, and/or lipemic.
3 - 23
hp
Explanation:
Result is higher than the panic interval.
What to Do:
Follow laboratory’procedure for panic values that are out of range.
LO
Explanation:
Result is lower than the reference interval.
What to Do:
Result may be reported.
Low ‘A’ error (Low ‘A’ err)

Explanation:
The absorbance at the measurement wavelength was lower than the limit set
in the system software for that assay.
What to Do:
Urine drugs of abuse assays should be centrifuged and rerun. For other assays,
manually dilute the sample and rerun the assay. Make the smallest dilution
possible to bring the result down into the assay range. Enter the dilution factor
as a whole number on the Enter Sample Data screen and the instrument will
multiply the result by this factor.
lp
Explanation:
Result is lower than the panic interval.
What to Do:
Follow laboratory procedure for panic values that are out of range.
Measurement
Explanation:
During photometric measurement, the system detected an insignificant
software timing error.
What to Do:
Rerun sample.
• If this error recurs for a photometric assay, a problem may exist in the
instrument measurement system. Call the Technical Solutions Center.
• If this error recurs for an IMT assay, troubleshoot the IMT error message.
3 - 24
No Reagent
Explanation:
There is no reagent cartridge on the reagent tray for this assay.
What to Do:
Load a new reagent cartridge into the instrument. If a reagent cartridge was
previously loaded but did not obtain any results, check for and troubleshoot
any reagent preparation errors listed on the Error Log screen.
Not Calibrated (no calib’n)

Explanation:
The assay lot used for this assay was never calibrated or verified.
What to Do:
Calibrate/verify the assay lot number.
Process Error
Explanation:
An error occurred that prevented the system from determining the result.
What to Do:
If this error message appears in the message field on the screen, press Alt/M
and follow the steps that appear. If it does not appear in the message field, go
to the Error Log screen. Move the cursor to the error, press F5: MORE INFO,
and follow the steps to resolve it. To navigate to the Error Log screen from the
Operating Menu, press F5: PROCESS CTRL > F6: ERROR LOG.
Substrate Depletion (subst dplet’n)

Explanation:
The kinetic check on the reaction exceeded the limits set in the system
software for that assay.
What to Do:
Manually dilute the sample and rerun the assay. Make the smallest dilution
possible to bring the result down into the assay range. A minimum dilution of
1:10 is recommended. Enter the dilution factor as a whole number on the
Enter Sample Data screen.
3 - 25
Temperature
Explanation:
This message appears when one of the following modules is outside of
temperature range: cuvette, HM incubation wheel, and LOCI reader module.
What to Do:
Check the operating conditions status area for a temperature icon.
If a cuvette temperature icon is present in the status area, calibrate the cuvette
system temperature. If an HM temperature icon is present in the status area,
calibrate the HM temperature. If a LOCI temperature icon is present, call the
Customer Care Center - Technical Solution.
3 - 26
Dilution Examples
This section contains three examples of dilutions and how they are used to
resolve samples with test report messages.
Dilution of a Sample
When a result exceeds the assay range for an assay, the Dimension EXL system
will automatically dilute the sample and rerun the assay.
If the test result still exceeds the assay range the printed test report will
contain the message “assy rng/dilu” indicating that the instrument diluted the
sample and the result is still above the assay range for the assay.
Make a manual dilution of the sample and rerun it. If the sample can be
diluted, make the smallest dilution possible to bring the result down into the
assay range. Make a dilution slightly greater than what was done by the
instrument.
To run this diluted sample, enter the number 5 in the Dilution field on the
Enter Sample Data screen and the instrument will multiply the result by this
factor.
Mixture of a Sample and a Known Standard

If a test result is low (below the reportable assay range), a mixture of the
sample with a known standard may be rerun to confirm the result was below
the reportable assay range, that there was adequate volume of sample used by
the instrument, and that there was no system malfunction.
Example:
The “assay range” test report message was printed next to a TP result of 0.5 g/
dL on the printed test report. Before reporting a result of “less than 2.0 g/dL,” a
mixture of the sample with a known standard must be rerun to confirm the
result.
Make a mixture of equal volumes of sample and a known standard. Run this
mixture and obtain a result. Enter this mixture result into the formula below.
If the calculated sample concentration matches the original sample
concentration, then a result of “less than 2.0 g/dL” may be reported for the
original sample.
(Mixture Vol * Mixture Result) – (Std Vol * Std Conc) = Calculated Sample Conc
Sample Vol
Volume of sample = 0.5 mL
Volume of known standard = 0.5 mL
Mixture volume = Volume of sample + Volume of known standard = 1.0 mL
Concentration of known standard = 10.0 g/dL
Result of running the mixture on Dimension EXL = 5.25 g/dL
(1 mL * 5.25 g/dL) – (0.5 mL * 10.0 g/dL) = 0.5 g/dL
0.5 mL
3 - 27
Since this calculated result matches the original sample result of 0.5 g/dL
report a result of “less than 2.0 g/dL” for the original sample.
50% Recovery of a Known Standard Using a Sample

If a sample has a negative result, a 50% recovery of a known standard may be
done to confirm that there was no activity in the sample, that there was
enough volume of sample used by the system, and that there was no system
malfunction.
For example, the “assay range” test report message was printed next to an ALC
result of -1 on the printed test report. Before reporting no activity or “0,” a 50%
recovery of a known standard may be performed.
Prepare a 1:2 dilution of a known standard using the formulas below. If the
ALC assay result for this mixture matches the concentration of ALC in the
known standard, then a “0” may be reported for the original sample.
To run this mixture, enter the number 2 in the Dilution field on the Enter
Sample Data screen and the system will multiply the result by this factor.
3 - 28
Test Report Message Priorities

There is room for only one test report message for each test result on the
printed test report. If a test had more than one message associated with it, the
message with the highest priority will appear.
Table 3-8: Test Report Message Priorities
Report Message Priorities
Highest Priority System Error
Process Error
Aborted Test
Clot Check Err
No Reagent
No Calib’n
Arithmetic
Above Assay Range
Below Assay Range
Abnl Assay
Subst Dplet’n
To Antigen Excess
High ’A’ Err
Low ’A’ Err
Absorbance
Hemoglobin
Measurement
Assay Rng/Dilu
Assay Range
HIL Interf
Calib’n Exp’d
Diluted
Lowest Priority Temperature
3 - 29
3 - 30
Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Calibration and Quality Control
Chapter 4: Calibration and

Quality Control
4-1
Calibration and Quality Control Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Calibration and Verification Overview

Calibration and Verification is performed to maintain the accuracy of the
measurement processes for assays used on the system.
Operators calibrate nonenzyme assays and verify enzyme assays. Assays on
the instrument are referred to as either photometric or chemiluminescent
assays except for Na, K, and Cl. These must be calibrated through the IMT
system.
For photometric assays, the Dimension EXL system uses the following
equations to convert an absorbance reading into concentration of analyte:
For logit methods: Conc =

For linear and verify methods: Conc = (C1 x ΔAbs) + C0
Y = mx + b
For chemiluminescent methods (LOCI) the Dimension EXL system uses the
following equation to convert signal (kcounts) into concentration of analyte:
Calibrating the IMT System

The IMT system automatically performs a two-point calibration:
• Every two hours
• After a condition cycle
• After you prime Standard A, Standard B, Salt Bridge Solution or Flush
• After you replace Standard A, Standard B, Salt Bridge Solution or Flush
• After you replace the QuikLYTE integrated multisensor
The IMT system can be calibrated on demand. See “Calibrating the IMT System”
on page 18 of this chapter.
4-2
Calibrating Urine Drugs of Abuse Assays

To calibrate urine drugs of abuse assays in either the qualitative or
semi-quantitative mode, refer to the “Calibrating Urine Drugs of Abuse
Methods” procedure in the Urine Drugs of Abuse Manual Supplement.
In the semi-quantitative report mode, the assays have a multilevel logit-type
calibration procedure; in the qualitative report mode, the software reserves
the SerumQC3 fluid for calibration and stores a cutoff.
Note: The urine drugs of abuse assays are: AMPH, BARB, BENZ,
COC, EXTC, METH, OPI, PCP, and THC.
Calibrating HA1C
To calibrate the HA1C assay, refer to the “Calibrating the Hemoglobin A1c
(HA1C) Assay” procedure in the Hemoglobin A1c (HA1C) Kit Supplement.
Calibrating HB1C
To calibrate the HB1C assay, refer to the Hemoglobin A1c (HB1C) Kit
Supplement.
When to Calibrate or Verify Photometric and LOCI Assays

Perform Calibration or Verification for an assay whenever:
• Reagent lots are changed.
• Whenever its calibration time interval has expired.
• Whenever a new assay is added.
Calibrate or verify C3, C4, CCRP, CRBM, CRP, GENT, HA1C,HB1C, IGA, IGG, IGM,
LIDO, MALB, MPAT, NAPA, PALB, PHNO, PROC, PTN, RCRP, THEO, TOBR, TRNF,
VALP, and VANC whenever the source lamp is replaced because these assays
are light-dependent.
The system processes samples using reagent lots that have an expired
calibration or verification status, but prints and displays a “Calib Expired”
processing message with the results. The system will not use a reagent lot that
has not been previously calibrated or verified on the system or whose
calibration has been rejected by the operator.
4-3
Calibration Alert
The Calib Alert key can be configured to change color when a calibrated lot
approaches or reaches its expiration date and when a Flex cartridge is in
inventory but not calibrated. The threshold used (1 to 240 hours before
expiration) is operator-assigned and is the same for each method. See
“Configuring Calibration Alerts” in Chapter 8.
1. When the Calib Alert key is yellow, select it to display the Calibration
Alert screen.
Table 4-1: Calibration Alert Fields
Field Information
Method The assay related to the alert.
Lot Reagent lot number of the assay.
Alert or Will Expire In Provides these messages:

• Expiration time
• EXPIRED, if calibration time has elapsed
• CAL REQUIRED, if a reagent cartridge is in inventory and not
calibrated
• AUTO ACCEPT, if automatic calibration acceptance failed
2. From the Calibration Alert screen, the operator can perform several tasks
by selecting the appropriate function key.
Key Task
F1: SET UP & RUN Highlight a method and press this key to display the Calibration
Setup screen.
(see “Setting Up and Running a Manual Calibration” section later in
this chapter).
F2: CALIB REVIEW Highlight a method and press this key to display the Calibration
Review screen when the alert indicates auto-accept.
F3: GROUP CALS Press this key to display assays with calibrator alerts grouped by
Calibration Product.
See the “Group Calibration Alerts and Run Calibration Group” section
later in this chapter.
F4: CONFIG ALERTS Press this key to display the Configure Calibration Alerts screen.
See the“Group Calibration Alerts and Run Calibration Group” section
later in this chapter
F5: DEF CAL PRODCT Press this key to enter a calibration product.
4-4
Group Calibration Alerts and Run Calibration Group

QCC PowerPak® functions automate the input of calibrator values and allows
for auto-acceptance of calibrations according to predefined acceptance
criteria. In addition, the QCC PowerPak Group Calibration Alert function
minimizes setup steps by calibrating multiple assays from a single set of
calibration cups.
1. Select the Calib Alert key on the touchscreen to display the Calibration
Alert screen.
2. Select F3: GROUP CALS on the Calibration Alert screen to display the
Group Cal Alerts screen.
3. Highlight the group and select F2: SETUP GROUP.
4. If more than one calibrator lot is available, the Select Calibration Product
screen displays. If it does not display, skip to Step 5, otherwise do the
following:
a. Highlight the calibrator lot to be used.
b. Type Y in response to the prompt.
5. Enter initials in the Operator field.
6. To remove an assay from a group, highlight the method then select
F1: DELETE METHOD.
Note: Selecting F1: DELETE METHOD may need to be done when
the Volume Exceeded field reads Yes.
7. Select F8: QC YES/NO to toggle the Run QC field between Yes and No. If
Yes is chosen, at least two levels of QC must be run with the calibration
for the Auto Accept option to apply.
8. Select F4: ASSIGN CUPS to assign calibrator cups and, if Run QC is Yes,
QC cups.
9. A setup list will print automatically.
a. Select F7: LOAD/RUN to display the load list
b. Select F4: RUN to begin calibration processing.
4-5
Calibrating Photometric and LOCI Assays

Calibrations can be initiated manually by ordering through Calibration setup
and entering calibrator information.
Setting Up and Running a Manual Calibration

A completed calibration of an assay must be reviewed by the operator and
either accepted or rejected before a new calibration for the lot can be set up.
See “Reviewing and Accepting Calibration Results” on page 7 of this chapter.
1. Select F5: PROCESS CTRL > F1: CALIBRATION.
2. Enter password and select ENTER.
3. Select F2: SET-UP & RUN.
4. Select the assay to be calibrated by pressing its test key.
Note: Check the assay IFU for the calibrator/verifier product to use.
5. Check the information on the screen and make any changes to the fields
listed in the table below.
Table 4-3: Calibration Set-Up Screen
Field Information
Lot If this is not the correct reagent lot number, select F1: OTHER LOT.
Status The calibration status of this lot for the assay.
Operator Enter initials.
Calibrator QCC PowerPak: Calibrator product name is automatically entered from

Product previously defined products. If multiple products are available, select one from
the list.
Manual: Enter the calibrator product name.
Calibrator Lot QCC PowerPak: Lot number is automatically entered from previously defined
calibrator products.
Manual: Enter the calibrator lot number. The system uses the same calibrator
cup for assays which are in the Calibrator Product/Lot field. In this case, enter
the calibration lot number in only one set of cups for each calibration setup.
Start at Position Enter the segment position where the first cup will be placed. Do not use SSC
segments for calibrations.
Bottle Values QCC PowerPak: Bottle values are automatically entered from previously defined
calibrator products.
Manual: Enter the bottle values from the calibrator product IFU in ascending
order (lowest to highest).
Note: The status field for an assay lot can either Never Calibrated,
In Progress, Not Accepted, Calibrated, or Expired. A
calibration cannot be set up for an assay if its status is “Not
Accepted”. Accept or Reject the calibration before proceeding.
6. Select F8: QC YES/NO to change the QC Levels fields to Yes.
4-6
7. Select F4: ASSIGN CUPS.

8. Repeat Step 4 through Step 7 to set up more assays for calibration.
9. Select F7: LOAD/RUN to display the Load List screen and view a summary
of all the calibrations you have set up.
10. Load the samples as indicated on the Load List.
11. Select F4: RUN or press RUN.
Note: After pressing RUN, the Status field changes to In Progress.
When the calibration is finished, the Status field changes to
Not Accepted.
Reviewing and Accepting Calibration Results

When the calibration is complete, a report slip is printed.
If the Auto Acceptance option is configured and the calibration passes all
acceptance criteria, skip Step 1 and Step 2.
1. From the Operating Menu, select Calib Alert key then select F2: CALIB
REVIEW. Select the assay by pressing its test key. If the correct lot
number is not displayed, select F1: OTHER LOT.
Note: HM assays have a different number of replicates per level of
calibrator depending on the specific HM assay being
calibrated.
a. Select: F5: PROCESS CTRL > F1: CALIBRATION.
b. Enter a Password and select ENTER.
c. Select F3: REVIEW DATA.
d. To display tests setup for Auto Acceptance that do not auto accept,
select Calib Alert. Highlight the method with the Auto-Accept alert.
e. Select F2: CALIB REVIEW.
4-7
2. Review the individual calibration results for precision. If there are no

obvious outliers, continue with Step 3.
a. For linear assays: Delete up to three obvious outliers; however
ensure that at least two results in each calibration level is retained.
If there are more than three obvious outliers, select F8: REJECT
DATA. See “Troubleshooting Precision of Calibration Results” on
page 11 of this chapter.
b. To delete a result, move the cursor to the result and select F3:
DELETE RESULT.
c. For logit assays: Outliers cannot be deleted. Select F8: REJECT
DATA if there are any obvious outliers for a logit assay calibration.
See “Troubleshooting Precision of Calibration Results” on page 11
of this chapter to resolve the problem.
Note: If a result is inadvertently deleted, type any number in the
field where the result was deleted to restore the result.
3. Review the calibration statistics m, b, and r that appear on the bottom of
the screen and decide if these values are acceptable.
Table 4-4: Acceptable Criteria for Calibrations
Linear Logit
Slope (m) 0.97–1.03 Slope (m): 0.95–1.05
Intercept (b) 0.0 or clinically insignificant Intercept (b): 0.0 or clinically insignificant
Correlation Coefficient (r) 0.990 - 1.000 Correlation Coefficient (r): 0.990 - 1.000
Note: When reviewing assays set up for auto-acceptance, items

that passed acceptance criteria are displayed in green. Items
that failed acceptance criteria are displayed in red.
a. Select F2: ACCEPT DATA. The status field on the screen changes to
CALIBRATED.
b. If the calibration statistics are not acceptable, reject this calibration
by selecting F8: REJECT DATA.
Note: See “Troubleshooting Calibration Statistics” on page 11 of
this chapter to resolve the problem and rerun the calibration.
Cancelling a Calibration
A calibration can be cancelled only if it has been scheduled. After cancellation,
the Calibration Set Up screen status field changes to Not Accepted for that lot.
The lot will then need to be rejected and recalibrated.
1. From the Calibration Set Up screen, select F4: CANCEL CALIB.
2. Select EXIT.
3. Select F3: REVIEW DATA.
4. Select the test key for the assay being cancelled.
5. Select F8: REJECT DATA and press Y.
4-8
Viewing Calibration History

Use the Calibration History screen to view and print information about
completed calibrations. This screen is password-protected.
When the screen displays and an assay is selected, the most recent calibration
is shown. Use the function keys to find the calibration information needed.
1. Select F5: PROCESS CTRL > F1: CALIBRATION > F7: CALIB HISTORY.
Table 4-5: Calibration History Screen Function Keys
Key Function
F1: <==PREV CAL Displays the previous calibration.
F2: NEXT CAL==> Displays the next newest calibration.
F3: SEARCH BY LOT Searches for a specific lot number.
F4: PLOT PRINT Presents the information in a plot format that can be printed.
F6: SEE QC/SHOW HB Toggle key. Displays the QC result.

SHOW HB is available only for HA1C/HB1C calibrations.
F7: SEARCH CALIB Displays calibration history for a Calibration ID that was specified.
F8: SHOW RESTORED Displays the restored Calibration.
Restore Calibrations screen

The Restore Calibrations feature provides operators with the ability to restore
previously accepted calibration records. This provides an alternative to
performing a new calibration on a previously calibrated lot. The system is
limited to two active lots per assay.
The calibration to be restored, must be selected (viewed) on the Calibration
History screen before it can be restored.
The reagent lot number on the calibration record must match the active lot
number on the system.
Open Channel assay calibrations can be restored, provided there are no
changes made to the method parameters since calibration.
If an assay parameter changes in a way that invalidates calibration, that
calibration can no longer be restored.
4-9
Restoring a Calibration
1. From the Home screen, select F5: PROCESS CTRL > F1: CALIBRATION.
2. Enter a password and press ENTER.
3. Select F7: CALIB HISTORY.
4. Select an assay (method).
5. Use F1: <== PREV CAL or F2: NEXT CAL ==> to scroll through all
available archived calibrations for that assay or search by calibration id
and date until the desired record is selected.
Note: The Dimension instrument can only store the 70 most recent
calibrations run per assay. Any additional calibrations will
overwrite existing assay records in the system.
6. Select F5: RESTORE CAL.
7. Press ENTER to confirm the calibration.
Note: If Exit or any other key is entered, the restore calibration is
canceled.
8. Enter initials and press ENTER. A calibration restore record is created.
Note: The calibration will not be restored if operator initials are not
entered.
When a calibration is successfully restored, the calibration data is loaded as the
active instrument calibration for that lot. The original calibration date (not the
restoration date) remains in effect. The restoration date and the initials
entered when the calibration was restored are preserved.
A new calibration history record (file) is created for the assay. Restored
calibration history records are grouped separately from standard calibrations.
They can be viewed by selecting F8: VIEW RESTORED. Restored calibrations
display the date of restoration and the user’s initials.
4 - 10
Calibration Troubleshooting
This topic describes troubleshooting for a calibration that has unacceptable
precision, calibration statistics or quality control.
Troubleshooting Precision of Calibration Results

• Review calibrator preparation, storage conditions, and expiration date on
the calibrator product IFU. For lyophilized products, follow the preparation
steps precisely.
• Review the instrument maintenance logs and the System Counters screen
for any maintenance that may be overdue. Check the cycle count for the
sample probe tip, especially on assays with a low sample volume.
• Check that all temperatures are within range on the Daily Maintenance
screen. Check the temperatures with a calibrated thermometer using the
“Calibrating Cuvette System Temperature” , “Calibrating Reagent System
Temperature” , and “Calibrating HM Temperature” procedures in Chapter 5:
Maintenance.
• If any data points are missing due to a process error:
• For logit assays, reject the calibration.
• For linear assays, up to three data points can be missing as long as
there are two data point for each level.
Troubleshooting Calibration Statistics

• Ensure that you are using the IFU from the correct calibrator lot.
the calibrator product IFU. For lyophilized products, follow the preparation
steps precisely.
• Check that the sample cups were loaded into the segment in the proper
order. If they were not, select F8: REJECT DATA and rerun the calibration.
• Review the system maintenance logs and the System Counters screen for
any maintenance that may be overdue. Check the cycle count for the
sample probe tip, especially on assays with a low sample volume.
screen. Check the temperatures with a calibrated thermometer using the
“Calibrating Cuvette System Temperature” , “Calibrating Reagent System
Temperature” , and “Calibrating HM Temperature” procedures in Chapter 5:
Maintenance.
• Compare the C4 term on the Calibration Review Data screen to the C4
value on the assay IFU. If it is not the same, contact Customer Care Center -
Technical Solution: Inside the U.S.: 1-800-441-9250; Outside U.S. refer to
the local support team. Only logit members have a C4 term.
4 - 11
Troubleshooting Quality Control

These suggestions for addressing QC Shifts assume optimal instrument
conditions and that the verification has met precision and accuracy guidelines.
• Ensure there is enough QC material in the sample cup and repeat
the QC using the same sample cup.
• Use the correct control product/lot number
• Rerun the QC using a fresh vial of QC material.
• Run an alternate control product or a different lot number of the
same product.
• Compare established QC ranges to peer group.
• Run previously reported patient sample containing acceptable
performance values.
• Run patient crossovers (split patient samples).
4 - 12
Verifying Photometric Assays

Verifications can be manually initiated by ordering through Calibration setup
and entering verifier information.
Setting Up and Running a Verification

A verification must be reviewed and either accepted or rejected. See
“Reviewing and Accepting Calibration Results” on page 7 of this chapter before
a verification for this lot can be set up.
2. Enter a Password and select ENTER.
Note: The Status field options for an assay can be Never
Calibrated, In Progress, Not Accepted, Calibrated, or
Expired. Operators cannot set up a verification for a method
if its status is Not Accepted. Accept or Reject the verification
before proceeding.
4. Select the test key of the assay to be verified.
Note: Check the assay IFU for the calibrator/verifier product to use.
Use the calibrator product IFU for the product name, product
lot number, and bottle values.
5. Check the information on the screen and make any changes to the fields
listed in the table below.
Table 4-6: Calibration Set-Up Screen
Field Information
Lot If this is not the correct reagent lot number, press F1: OTHER LOT.
Status The status of this lot for the method. A verification for this lot cannot be set up
if its status is “Not Accepted”.
Operator Enter initials.
Calibrator QCC PowerPak®: Verifier product name is automatically entered from

Product previously defined products. If multiple products are available, select one from
the list.
Manual: Enter the verifier product name.
Calibrator Lot QCC PowerPak: Lot number is automatically entered from previously defined
verifier products.
Manual: Enter the verifier lot number.
Bottle Values QCC PowerPak: Bottle values are automatically entered from previously defined
verifier products.
Manual: Enter the bottle values from the verifier product IFU in ascending
order (lowest to highest).
6. Select F8: QC YES/NO to change the QC Levels fields to Yes.
4 - 13
7. Select F4: ASSIGN CUPS.

8. Repeat Step 4 through Step 7 to set up more assays for verification.
9. Select F7: LOAD/RUN to display the Load List screen and view a summary
of the verifications you have set up.
10. Load the samples as indicated on the Load List.
11. Select F4: RUN or RUN. The Status field changes to “In Progress”.
Note: After the verification is run, the Status field changes to “Not
Accepted”.
Reviewing and Accepting Verification Results

When the verification is complete, a report slip is printed.
If the Auto Acceptance option is configured and the verification passes all
acceptance criteria, skip Step 1 through Step 6.
1. Select: F5: PROCESS CTRL > F1: CALIBRATION.
2. Enter password and select ENTER.
Note: The Calibration Review screen can also be accessed for
assays that failed auto-acceptance criteria by selecting Calib
Alert. Highlight the assay that is displaying an Auto-Accept
alert and select F2: CALIB REVIEW.
4. Press a test key to select the method. If the correct lot number is not
displayed, select F1: OTHER LOT.
Note: To display assays not set up for Auto Acceptance, from the
Operating menu select F5: PROCESS CTRL >
F1: CALIBRATION > F3: REVIEW DATA.
5. Review the individual verification results for precision. If there are no
obvious outliers, continue with Step 6.
Note: Do not select F7: CALCULATE.
a. If there are obvious outliers:
1) Delete up to three obvious outliers, but retain at least two
result in each level. If there are more than three obvious
outliers, press F8: REJECT DATA. See “Troubleshooting
Precision of Calibration Results” on page 11 of this chapter to
resolve the problem.
2) To delete a result, move the cursor to the result and select
F3: DELETE RESULT.
Note: If a result is inadvertently deleted, select EXIT and begin
reviewing and accepting verification results again.
4 - 14
6. Review the verification statistics m, b, and r that appear on the bottom of

the screen and decide if these values are acceptable.
Note: To print a plot of the verification results, select
F4: PLOT/PRINT and type Y for yes.
Table 4-7: Acceptable Criteria for Verifications
Slope (m) Intercept (b) Correlation Coefficient (r)
0.90–1.10 0.0 or clinically insignificant 0.990–1.000
• If the verification statistics are acceptable, select F2: ACCEPT DATA (the
Status field on the screen changes to CALIBRATED).
• If the verification statistics are not acceptable, reject this verification by
selecting F8: REJECT DATA. See “Verification Troubleshooting” on page 16
of this chapter to resolve the problem and rerun the verification.
Cancelling a Verification
A verification can be cancelled only if it has been scheduled. After cancelling
and rejecting a verification, the Calibration Set Up screen Status field changes
to Rejected for that lot.
1. From the Calibration Set Up screen, select F4: CANCEL CALIB.
2. Select EXIT.
4. Press the method test key for the assay that was cancelled (be sure to
check the Lot number).
5. Select F8: REJECT DATA and enter Y.
4 - 15
Verification Troubleshooting
This topic describes troubleshooting for a verification that has unacceptable
precision, calibration statistics or quality control.
Troubleshooting Precision of Verification Results

• Review verifier preparation, storage conditions, and expiration date on the
verifier product IFU.
sample probe tip.
screen. Check the temperatures with a calibrated thermometer according
to the “Calibrating Cuvette System Temperature” . See “Calibrating Reagent
System Temperature” on page 25 of Chapter 5: Maintenance.
• If any data points are missing due to a process error, up to three data
points can be missing as long as there is at least two data points for each
level. If the verification meets the criteria, it can be accepted.
Troubleshooting Verification Statistics

• Ensure that the IFU from the correct verifier lot is used.
the calibrator product IFU. For lyophilized products, the preparation steps
must be followed precisely.
• Check that the sample cups were loaded into the segment in the proper
order. If they were not, select F8: REJECT DATA and rerun the verification.
sample probe tip.
screen. Check the temperatures with a calibrated thermometer. See
“Calibrating Cuvette System Temperature” on page 23 of Chapter 5:
Maintenance.
• The F7: CALCULATE function key is not used in verification. If it is pressed,
be sure to select F7: UN-CALCULATE before accepting the verification. If
F2: ACCEPT has been pressed, contact the Customer Care Center -
Technical Solution:Inside U.S.: 1-800-441-9250; Outside U.S. Refer to the
local support team.
4 - 16
Troubleshooting Quality Control

These suggestions for addressing QC Shifts assume optimal system conditions
and that the verification has met precision and accuracy guidelines.
• Ensure there is enough QC material in the sample cup and repeat
the QC using the same sample cup.
• Use the correct control product/lot number
• Rerun the QC using a fresh vial of QC material.
• Run an alternate control product or a different lot number of the
same product.
• Compare established QC ranges to peer group.
• Run previously reported patient sample containing acceptable
performance values.
• Run patient crossovers (split patient samples).
4 - 17
Calibrating the IMT System

1. Select F4: SYSTEM PREP > F3: IMT > F2: CALIBRATION >
F1: CALIBRATE.
2. After the calibration is completed:
a. If all assays (Na, K, Cl) passed calibration, the system displays an
IMT OK message in the IMT status box.
b. If one or more assays did not pass calibration, either:
• The system displays the uncalibrated assays in red in the IMT
status box.
• The IMT calibration has asterisks in the slope field for the
uncalibrated assay.
• The IMT Calibration screen will contain the slope reading with
asterisks to the left of the reading.
Note: It is possible to override a specific IMT assay or troubleshoot
the IMT to resolve a failed IMT calibration. See “IMT
Troubleshooting” on page 14 of Chapter 7: Troubleshooting.
3. To override a specific IMT assay, use the arrow keys to move the cursor
box in the Override column to the required assay.
4. Select ENTER to change the field to Yes. If the K assay is overridden, the
Na assay will also be overridden.
Electrolyte Coefficients
The following are the default coefficients used by the software when urine is
selected as the fluid type:
Table 4-8: Urine Default Coefficients
C0 C1
Na+ 0 1.0
K+ 0 1.0
Cl- 0 1.06
To compare the QuikLYTE system results to other indirect “diluted” electrolyte

systems, use the C0 and C1 coefficients recommended in Table 4-9.
Table 4-9: Recommended
Indirect (diluted) C0 C1
Na+ 1.5 1.01
K+ –0.2 1.05
Cl- –10.0 1.09
4 - 18
Using Calibration Status Lists

2. Enter Password and select ENTER.
3. Select F1: STATUS LIST.
The Calibration Status List screen can be used to:
• Create a list of assays for calibration.
• Send alerts for calibration intervals due to expire within a specific time
period.
• Permanently remove reagent cartridges from instrument memory that
have expired or are used up. See “Remove Calibrations from Instrument
Memory” on page 20 of this chapter for more information.
Create a List of Methods for Calibration

1. From any Calibration Status List screen, move the cursor to the assay and
select F3: SELECT.
a. Select function key F7 to view four other groups of this information
as described in Table 4-10.
b. To see a list of all the selected methods, select F7: SELECTED LOTS.
Table 4-10: Calibration Status Lists
List Contents
Recommended Shows a list of reagent lots that are within X hours of their expiration date.
Lots
Same Product Shows all reagent lots that use the same calibrator/verifier product.
All Lots Shows all reagent lots that are in system memory.
Selected Lots Shows all the selected reagent lots to be calibrated/verified from the three
status list screens listed above.
2. Select EXIT to display the Calibration Set Up screen.

4. Select F5: NEXT METHOD to display each assay in the Selected Lots List
that was created.
Deleting a Selected Calibration

1. Select F7 until the ”Selected Lots“ grouping of the Calibration Status List
screen appears.
2. Move the cursor to the assay.
3. Select F3: DELETE.
4 - 19
Create a Reminder List for Expiring Calibrations

The Calibration Status List screen displays the reagent calibrations that will
expire within a specific number of hours.
After entering the number of hours in the “expires in” field, the screen is
updated automatically to show a list of reagent cartridge calibrations that will
expire within that number of hours. The instrument will also print out this list
automatically. The list is also included in Daily Maintenance printouts.
To enter a value in the “expires in” field:
1. Select F4: EXP PERIOD.
2. Type the number of hours.
3. Select ENTER.
Note: If the calibration alert key has been configured, the system
will alert the operator to calibrations that are expiring.
Remove Calibrations from Instrument Memory

1. Select F5: OFFBOARD LOTS.
Note: This screen can be accessed from any Calibration Status List
screen, by selecting F2: OFFBOARD LOTS.
2. Move the cursor to the assay to be deleted from instrument memory.
3. Select F3: DELETE.
4. Repeat Step 2 and Step 3 for each assay lot that will be permanently
removed from system memory.
Note: Be sure to check the assay lot number on the screen before
deleting. If another reagent cartridge with this lot number is
used, the lot will need to be recalibrated unless a previous
calibration can be restored. See the section titled “Restoring a
Calibration” in this chapter.
4 - 20
Calibration (or Verification) Setup Flow Chart

Figure 4-1: Calibration/Verification Setup Flow Chart
4 - 21
Calibration (or Verification) Review Flow Chart

Figure 4-2: Calibration/Verification Flow Chart
4 - 22
Quality Control
Quality control (QC) is a system of checks to ensure that the system and its
associated materials meet with the laboratory’s acceptable standards of
performance.
The laboratory is responsible for the proper functioning of the Dimension EXL
system after installation. Siemens assists in setting up the system and ensures
that the assays to be used initially are calibrated and verified.
Quality Control Program

A quality control program should monitor all assays and show changes in the
system that may affect patient results. It also takes into account those sources
of nonanalytical errors which may affect results.
Routine quality control procedures involve checking known samples for
reproducibility and accuracy on the Dimension EXL system. The assay IFUs
describe typical performance characteristics for each assay.
Recommended quality control practices include the following:
• Perform System Check at least once per day.
• Process two levels of quality control material at least once every 24 hours
per assay used.
• Perform calibration/verification whenever the reagent lots for an assay are
changed and at the calibration and verification intervals specified in the
associated assay IFU.
The Dimension EXL system includes software to assist in maintaining
information necessary for a good quality control program, including:
• Storage of at least 100,800 QC results, allocating up to 540 points for each
assay, meaning storage from 108 to 270 days of results.
• The ability to display these results as a histogram or as a
Levey-Jennings–like plot.
• The ability to display QC results for a specific period of time, to display lines
from one to four standard deviations on the Levey-Jennings-like plot, and
to keep specific QC results from being used in the creation of these plots.
Note: QC results cannot be deleted from the QC memory.
Daily QC
Check the Dimension EXL system daily for proper performance by using one of
the System Check procedures found in Chapter 2: System Operation, and by
performing routine maintenance as described in Chapter 5: Maintenance.
Each day run two levels of quality control material of known activity or
concentration for each assay that will run during that day. If the results are
outside laboratory acceptable limits, investigate the cause immediately.
4 - 23
QC Materials
The quality control material used should not be the same material that was
used to calibrate or verify an assay. This could cause an undetected error and
lead to inaccurate results.
Carefully follow the procedures provided by the manufacturer of the quality
control material for handling and reconstruction.
It is best to use a quality control material with a concentration (or activity) at a
clinical decision-making level (as used by the laboratory).
New Reagent and Control Lots

Siemens recommends that operators compare new lots of reagent and control
products with lots that have given acceptable performance.
Each new quality control product or new lot of quality control material
introduced should be evaluated in conjunction with the old lot during a trial
period. This allows the newly established mean and standard deviation to be
compared to the values of the old material.
Quality Control Review

Determine if the system is processing samples precisely and accurately by
performing QC on the system. The instrument’s computer keeps track of the
QC status of each assay on the system.
To perform QC, process QC samples that have a known value and compare the
measured results to that known value. Check the laboratory guidelines for
interpreting QC results.
Processing QC Samples
When processing a QC sample for an assay, the system runs a test using each
Flex reagent cartridge lot that is on the system for that assay. All QC samples
are processed like patient samples.
When the test results are complete, the QC status becomes valid and the QC
expiration time period begins. If another QC sample isn’t processed before the
QC expiration time period is up, the QC status for that method expires.
The QC expiration time period can be determined by using the Quality Control
Status List screen.
Crossover QC
Before using a new lot of QC material, you will want to perform crossover QC
tests on it. If you give a sample of the new lot of QC material a crossover QC
priority (XQC) on the Enter Sample Data screen, the system provides results for
the sample to use in calculating your new QC ranges for the new lot. However,
since the system does not compare these crossover QC results to the QC
ranges of the current lot number of QC material, these results do not affect the
QC status of the method. Crossover QC results are stored in the Method Review
files.
4 - 24
QC for Urine Drugs of Abuse Assays

For QC of Urine Drugs of Abuse assays (AMPH, BARB, BENZ, COC, EXTC, METH,
OPI, PCP, and THC) refer to the procedure “Processing Quality Control Tests” in
the Urine Drugs of Abuse Supplement.
Note: Follow this procedure exactly and be sure not to use the
SerumQC3 fluid for any QC sample. The SerumQC3 fluid is
specifically reserved for calibration of these assays.
WARNING: For urine Drugs of Abuse assays, negative and positive quality
control samples must be run using the fluid types SerumQC1,
SerumQC2, UrineQC1, or UrineQC2. Processing QC samples as
SerumQC3 overrides the current calibration and could result
in an erroneous calibration of these methods.
Note: When processing QC Samples for Urine Drugs of Abuse
Assays, follow the QC procedure in the Urine Drugs of Abuse
Supplement.
4 - 25
Using the QC Alert Key

The QC Alert key changes color to yellow when the QC result for an assay
meets any of the following configurable alerts:
• Out of range. For this alert condition, QC ranges must be configured.
• Has an error message and no result.
• Expired. The alert uses the QC expiration period.
• Result is greater than 2SD.
When the QC Alert key is yellow, select it to display the QC Tests Out of Range
screen and view the Result (described in Table 4-11)
Table 4-11: QC Tests Out of Range Results
Result Explanation
Expired The information about an expired QC remains on the screen up to 48 hours

after the time the QC reported results.
Error If an error occurs during QC processing which suppresses the result, the
assay is flagged on this screen.
High The QC result is above the upper limit of the stored QC range.
Low The QC result is below the lower limit of the stored QC range.
>2SD Indicates result is greater than two Standard Deviations.
Table 4-12 explains the tasks that can be performed with the QC Alert function
keys:
Table 4-12: QC Alert Function Keys
Key Task
F1: TEST RESULTS To view QC results, highlight the assay and select this key. See “Editing and
Rerunning a Sample” on page 10 of Chapter 3: Sample Reports.
F2: EDIT/RERUN To rerun the QC, highlight the assay and select this key. See “Editing and
Rerunning a Sample” on page 10 of Chapter 3: Sample Reports.
F3: CLEAR ALERT To clear an alert (change key color from yellow to gray) without rerunning
the QC, highlight the assay and select this key.
F4: CONFIG ALERT To set parameters for QC alerts, select this key. See “Configuring QC Alerts”
on page 50 of Chapter 8: Configuration.
F5: DEFINE QC PRODUCT To display the Define QC Product screen, select this key. See “Defining QC
Products” on page 28 of this chapter.
F6: GROUP ALERTS To group alerts with the same product definition, select this key. See
“Grouping QC Alerts” on page 31 of this chapter.
F7: METHOD REVIEW To review the QC levels and applicable Westgard rule, highlight the assay
and select this key. See “Reviewing QC Results” on page 42 of Chapter 4:
Calibration and Quality Control.
F8: PRINT To print the information on the screen, select this key.
4 - 26
Entering QC Ranges
1. Select F5: PROCESS CTRL > F4: QC RANGES.
2. Select the test key for the assay that will be edited.
3. Select the Lytes test key, then select F1: NEXT METHOD to see the K and
Cl assays.
4. For each QC level, enter the QC range (low and high), expected mean, or
expected SD as appropriate. The number of QC levels used determines
how many days of QC data can be stored in the software for an assay.
Note: For the auto-acceptance option enter a minimum of two QC
ranges.
Table 4-13: QC Levels
QC Levels Set for Each Assay Days of QC Results Stored for Each Assay
2 270 Days
3 180 Days
4 135 Days
5 108 Days
Setting a QC Expiration Period and Checking QC Status

Select F5: PROCESS CTRL > F3: QC STATUS to display the Quality Control
Status list.
Setting a QC Expiration Period

1. Using the Quality Control Status List screen, move the cursor to the
Period (hrs) column of the required assay.
2. Enter the new expiration period in hours. QC expiration periods must be
between 4 hours and 24 hours and must be entered in one-hour units.
Note: The system changes the expiration period for all lots of that
assay in system memory.
Setting the Same Expiration Period for All Methods

1. Move the cursor to the Period (hrs) field for any assay that already has
that expiration time.
2. Select F4: SET ALL SAME. To set the same expiration time for all assay:
a. Move the cursor to the Period (hrs) field for any assay.
b. Enter the expiration period in hours.
c. Select F4: SET ALL SAME.
4 - 27
Checking QC Status
An asterisk (*) to the left of the QC Expires column indicates that the QC for
that reagent lot has expired.
Defining QC Products
The Dimension EXL system will display up to 100 QC products. QC panels must
be defined using a previously defined QC product.
1. Select the QC Alert key.
2. Select F5: DEFINE QC PRODUCT.
3. Type the QC product name and select ENTER.
4. Type the product level and select ENTER.
5. Type the QC Lot number and select ENTER.
6. Use F3: NEXT QC FLD LEV to select a QC Level.
7. Use F4: NEXT FLUID to select the fluid appropriate for the product.
8. Change the Active QC and Cal fields with F5 and F6 if this product will be
active for daily QC and included with current calibrations and select
ENTER.
Note: For Auto Urine Dilute assays (BUN, CREA, CRE2, EZCR, PHOS,
URCA) toggle the F6 key to make the calibration fields
inactive.
9. Use the test keys to enter assays associated with the product.
10. Select F7: STORE.
a. To enter additional levels of the product, change the product level,
QC fluid level and select F7: STORE.
b. To define another QC product, select F1: NEW PRODUCT.
c. To view a list of defined products, display the Edit QC Products
screen.
4 - 28
Editing QC Products
1. Select: F5: PROCESS CTRL > F3: QC STATUS > F2: EDIT QC PRODUCT to
display the Edit QC Product screen.
2. Highlight the product to edit and use the appropriate function keys to
make changes.
Table 4-14: Edit QC Product Function Keys
Key Function
F1: EDIT PRODUCT Displays the information to be edited.
F2: DELETE PRODUCT Removes the highlighted product from the list.
F3: SORT BY PROD/QC FLD/FLUID Toggles among choices for sorting the QC products list by product
name, QC fluid level, and fluid.
F4: SEARCH Displays all products related to a specific assay.
F5: LOAD FROM PROD Displays the selected product to be edited.
F6: SET QC ACTIVE/SET QC Toggles between activating and deactivating QC.

INACTV
F7: SET CAL ACTIVE/SET CAL Toggles between activating and deactivating calibration.
INACTV
F8: PRINT Prints the information on the screen.
Defining QC Panels
Use this screen to create up to 50 different QC panel definitions with up to
36 methods in each. Panels are designed to be run in SSC (Small Sample
Container) placed on barcoded tubes.
When an SSC with a panel ID is processed, the system completes the following
actions:
• Queries the LIS, if configured for the ID.
• Searches the QC panel database for a match.
1. Select F5: PROCESS CTRL > F3: QC STATUS > F6: DEFINE QC PANELS.
2. Select F1: NEW PANEL to define the new QC Panel.
4 - 29
Using Previously Defined QC Product

1. Select F6: LOAD FROM PROD to display the Select QC Product screen.
2. Highlight the product and select F1: SELECT PRODUCT.
Note: Delete any tests from the product that will not be included in
the panel.
3. Select F5: ASSIGN SAMPLE ID. Either scan a barcode label or enter data
manually. Enter a unique reusable number for the QC panel.
Note: When scanning a barcode label, make sure the Caps Lock
function is turned off.
4. To delete a test, highlight it and select F2: DELETE TEST.
Note: If the volume (vol) exceeds 950 µL the volume will be
displayed in red and tests will need to be deleted from the
panel.
6. Select F1: NEW PANEL to define a new QC panel.
Editing QC Panels
Use the Edit QC Panel screen to view a list of defined QC panels and to edit the
panel.
1. Select F5: PROCESS CTRL > F3: QC STATUS > F7: EDIT QC PANEL.
Table 4-15: Edit QC Panels Function Keys
Key Function
F1: EDIT PANEL Displays the information to be edited.
F2: DELETE PANEL Removes the highlighted panel from the list.
F3: SORT BY PRODUCT Lists QC panels by product name, sample ID or level.
F4: SEARCH Displays all products related to a specific test method.
2. Highlight the panel to be edited and select F1: EDIT PANEL to make
changes.
3. Move the cursor to the field to be changed.
4. Type in the new QC product name or QC lot.
5. Use test keys to add tests or select F2: DELETE TEST to remove tests.
Note: If adding tests to a panel always add to the product first.
6. Use the function keys to change Sample ID, QC Fluid Level Types and
Priority. Priority options include QC Active (Quality Control) or XQC
(Crossover Quality Control).
4 - 30
Grouping QC Alerts
Use the QC Groups screen to combine assays with the same assigned QC
product and active QC alert into one sample ID and SSC. Using this feature
allows QC to be run on a maximum number of methods in a minimum number
of sample cups or SSCs in barcoded tubes.
1. Select the QC Alert key.
2. Select F6: GROUP ALERTS.
3. Move the cursor to a product.
4. Select F1: ASSIGN SAMPLE ID. Enter the ID by scanning the barcode or
by typing it.
5. Select ENTER.
6. Repeat Step 3 and Step 4 for additional products.
7. To remove assays that will not be processed, highlight the assay and
select F2: DELETE METHOD.
8. Select F5: Load One to select a sample for processing, or select F6: LOAD
ALL to process all samples listed.
Note: If this is a QC Rerun, move the sample to a new location.
9. To remove assays that will not be processed, highlight the assay and
select F2: DELETE METHOD.
10. Select F8: PRINT to create a report of the QC group.
4 - 31
Method Review of QC and Patient Results

1. Select F5: PROCESS CTRL > F7: METH REVIEW.
2. Select a test key to display results for a assay.
3. Check the time period and specific lot shown on the first line of this
screen. Change these entries to view the specific results set that are
needed.
Table 4-16: Method QC Review Screen Fields
Field To enter information in the field
Fluid Select F5: QC/PATIENT for patient results or QC results.

After selecting either, select F6: NEXT FLUID to see another fluid type.
[Time Period] Select F1: SET PERIOD/LOT.

• To see results for a specific month: Type the first 3 letters of the month
and select ENTER.
• To see results for a specific time period in days, type the number of the
days and select ENTER.
• To see results for a specific time period in hours, type the percent
symbol and the number of hours and select ENTER.
(Specific Lot) Select F1: SET PERIOD/LOT and type an asterisk (*) followed by the lot ID
number and select ENTER. To return to viewing results for all lots of the
method, select F1: SET PERIOD/LOT, type an asterisk (*) and select ENTER.
4. Select F3 to select the view of this information to be seen. Three views

are available: a Result listing, a Histogram plot, and a
Levey-Jennings–type plot.
5. Select F3 to move from one view to another.
Crossover QC results can also be selected for review
To view crossover QC results:
1. Select F1: SET PERIOD/LOT.
2. Type an asterisk (*) followed by the letters XQC.
3. Select ENTER.
To return to viewing non-crossover QC results:
1. Select F1: SET PERIOD/LOT.
2. Type an asterisk (*).
3. Select ENTER.
4 - 32
Results Listing View

1. Select F5: PROCESS CTRL > F7: METHOD REVIEW.
2. Select F8: PRINT from the Results Listing view of the Method Review
screen and answer the messages that appear. See the topic “Using F8:
PRINT”.
The Results Listing view can show patient or QC results depending on what
type of fluid is selected. The Results Listing view contains the following fields:
Table 4-17: Results Listing View Screen Fields
Field Meaning
Result Test result (units are those appearing in the Units field).
Error Any processing messages for the assay result.
Lot The lot ID of the Flex® reagent cartridge used to process the assay.
Sample ID ID of the sample.
Date Time and date that the sample was processed.
Using F8: PRINT

Answer two messages after selecting F8: PRINT:
Message 1-Do you want to print just a summary? (y/n)
Message 2-Do you want to print ALL Methods/Levels? (y/n)
Note: Respond with Y to Message 1, in order to display Message 2.
Use the Pg Dn and Pg Up keys on the keypad to see more of this list. The Tests
field shows how many results the list contains.
Asterisks (*) indicate that the data point has been deleted by the operator and
is not used in the information at the top of the screen.
When a patient fluid is selected, > and < signs indicate that the data point is
greater than (>) or less than (<) the limits shown in the Interval field.
4 - 33
When a QC fluid is selected, the > and < signs indicate that the data point
exceeds the rule (>) or is lower than the rule (<) shown in the Rule field.
Table 4-18: Fluid Type Chart & Answer Message
Answer
Message
If the Fluid Type Is To Print Out
1 2
Patient The summary information (the top half of the screen). The Y N
summary information and supporting data for the assay and
fluid combination. N
QC All QC information for all levels and assay. Y Y

The summary information (the top half of the screen). Y N
The summary information and supporting data for each level
of QC for the assay. N
All QC information for all levels and assay. Y Y
Note: If Y is applied to “All QC information for all levels and

methods”, the report prints the data in a standard 80-column
format.
Histogram Plot
To create a histogram plot, five results are required for the assay/fluid
combination. Each result must fall within the time period and the specific
reagent cartridge lot that appear on the top line of the screen.
Select: F3: SEE HISTOGRAM.
The X-axis shows the test result. The Y-axis shows the number of tests having that
test result.
For better viewing, use the left and right arrow keys on the keyboard to
change the scale of the X-axis as appropriate. The left arrow key expands the
range of the X-axis; the right arrow key compresses the range of the X-axis.
Printing Histogram Plot Information
1. To print only the data listed at the top of the view, select F8: PRINT.
2. To print the entire screen, select ALT+P.
Note: Both of these printouts can only be printed by the system
printer; they will not print to an external printer.
4 - 34
Levey-Jennings Plot Views

The Levey-Jennings plot view can be displayed for either patient results or QC
results.
To create a Levey-Jennings plot, five results are required for the assay/fluid
combination. Each result must fall within the time period and the specific
reagent cartridge lot that appear on the top line of the screen.
Levey-Jennings Patient Results Plot
1. Select F3: SEE L-J PLOT.
2. Select F5: QC/PATIENT until a patient fluid appears in the Fluid field.
• A green + is a result that is within the values in the Interval field.
• A red x is a result that is outside the values in the Interval field.
• A blue * is a result that has been deleted by the user.
3. To see the result value and date for a specific point, press the right or left
arrow key to move a marker onto the point.
Printing L-J Patient Information
1. To print the L-J plot, select F8: PRINT.
2. To print the entire screen, select ALT+P.
Note: Both of these printouts only use the system printer.
Levey-Jennings QC Results Plot
QC plots are created using the ACTUAL mean and SD values.
1. From the Histogram Plot view, select F3: SEE L-J PLOT (or from the L-J
Patients Results view, select F5: QC/PATIENT until a QC fluid appears in
the Fluid field).
2. Select F5: QC/PATIENT until a QC fluid displays in the Fluid field.
• A green + is a result that does not violate the rule in the Rule field.
• A red x is a result that violates the rule in the Rule field.
• A blue asterisk * is a result that has been deleted by the user.
The mean for the data appears as a solid line in the center of the plot and
its value is listed on the scale at the left side of the plot.
3. To see the result value and date for a specific point, press the right or left
arrow key to move a marker onto the point. The data for that point will
appear in the Marker field. A greater-than or less-than sign after the date
in this field indicates that the point exceeds (>) or is lower than (<) the
limits shown in the Interval field.
4 - 35
Changing the SD on the screen:

To reposition the dashed SD line to ±1, ±2, or ±3 SD:
1. Press the up or down arrow key. The dashed SD line is repositioned;
however, the SD values at the top of the screen do not change.
To change SD:
1. Select F4: SET INTERVAL.
2. At the prompt, enter an SD level between 1.0 and 4.0. (Select a decimal
SD by entering the letters SD after the decimal, for example, 2.5 SD.)
3. Select ENTER.
The Interval, In, and Out field values at the top of the screen and the colored
data points will change to reflect this new SD; however, the dashed SD lines on
the screen remain at ±2 SD.
Printing L-J QC Information
1. To print the 2SD plot, select F8: PRINT.
2. To print other SD plots created on the screen, press ALT+P.
Any deleted results on these printouts will appear as either an up or down
arrow, depending on whether the deleted result was above or below 2 SD.
Both of these printouts only use the system printer.
4 - 36
Method Review Screen — Fields

Table 4-19: Method Review Fields
Field Meaning
Fluid The fluid for the patient or QC results shown on the screen. Select F5: QC/PATIENT to go
from patient to QC results and vice versa. Select F6: NEXT FLUID to display results for
another fluid.
[dates] Time period brackets. If there is nothing entered in the brackets, all results in the test result
buffer for the assay and fluid combination display on the screen.
If a time period is entered, all screens (patient and QC) will display only results that fall
within this time period. See “Method Review Screen—Function Keys”.
(lot ID) Lot ID or crossover QC parentheses. If there is nothing entered in the parentheses, all results
for all reagent cartridge lots in the test result buffer for the method and fluid combination
display. If the parentheses contain the letters XQC, only crossover QC results display.
If a reagent cartridge lot ID or crossover QC is entered, all screens (patient and QC) will
display only those results that use the specific lot ID or are crossover QC results. See
“Method Review Screen—Function Keys”.
Tests The total number of results in the test result buffer that match the assay and fluid on the
screen (and, if specified, are within the specific time frame or are for the specific reagent
cartridge lot ID or crossover QC).
(Tests) The number and percentage of results in the Tests field that are within the Interval field
In shown on the screen.
(Tests) The number and percentage of results in the Tests field that are outside the Interval field
Out shown on the screen.
4 - 37
Field Meaning
Interval The interval to which results are compared to determine the numbers and percentages
shown in the In and Out fields.
See “Method Review Screen—Function Keys”.
Units Results units. These units are taken from the Method Parameters screen for the method.
Expecte Value only appears when QC results are selected. The value that appears (if any) was
d Mean entered by the operator on the Quality Control Ranges screen.
Expecte Value only appears when QC results are selected. The value that appears (if any) was
d SD entered by the operator on the Quality Control Ranges screen.
Actual The actual mean is calculated using all the Tests field results.
Mean
Actual The actual standard deviation is calculated using all the Tests field results.
SD
CV % The coefficient of variation percentage is calculated using all the Tests field results.
Rule The rule or constraint against which the results are compared. Each result is compared to
the Interval field to determine whether it exceeds or is below the interval.
Marker: This field contains the result and the date of the result corresponding to the position of the
( ) marker on Levey-Jennings–like plots. See “Levey-Jennings Plots”.
4 - 38
Method Review Screen — Function Keys

Function keys on Method Review screens are different depending upon
whether patient results or QC results are viewed.
The function keys for patient and QC result screens are described in
Table 4-20.
Table 4-20: Method Review Screen Function Keys
Function Key Patient Results QC Results
F1: SET Used to enter a specific time period in Same as patient results. Also
PERIOD/LOT brackets [ ] and a specific reagent allows crossover QC data to be
cartridge lot ID in the parentheses ( ) selectively displayed inside the
fields in the upper right corner of the parentheses ( ).
screen. See “Method Review Screen —
Fields” on page 37 of this chapter.
F2: DELET RESULT Patient results cannot be deleted. This Deletes the QC result where the
(F2: UN-DELETE) function key is disabled when patient cursor is positioned on the Data
results are displayed. screen or where the marker is
(Function key F2 is positioned on the L-J like QC plot.
always Delete For more information on deleting
unless the cursor and un-deleting results using this
or marker is function key, see “Reviewing QC
positioned on a Results” on page 42 of this chapter.
data point that has
been deleted).
F3: See DATA Used to display the results as a list, a Same as patient results.
(F3: See histogram, or a Levey-Jennings like
HISTOGRAM) plot. These views must be displayed in
(F3: SEE L-J PLOT) sequential order.
F4: SET INTERVAL Used to select results within a specific Same as patient results. Also
user-defined interval/ To enter a new allows a decimal SD to be entered.
range in the Interval field, select F4: Set See “Levey-Jennings Plot Views” on
Interval and at the prompt enter the page 35 of this chapter.
low range for the new interval and then
the high range. Select ENTER after each
entry. The In and Out fields will update
automatically based on the new range.
Note: When Using
F4: SET INTERVAL, all
Method Review Screens
for this assay/fluid
combination will use
this interval.
Note: The Interval field shows
the new interval as the
result histogram and L-J
plot views are displayed
for the assay and fluid
combination. It reverts
to the appropriate
intervals from the
Method Parameters
screen upon exiting and
reentering the Review
screen or when another
patient fluid or assay is
selected.
4 - 39
Function Key Patient Results QC Results
F5: QC/PRINT Used to change displayed results from Same as patient results.
patient to QC and vice versa.
F6: NEXT FLUID Used to display results for the next Used to display results for the next
patient fluid type. QC fluid type.
F7: SHOW mAU Used to toggle result units between Does not appear on the QC display.
SHOW CONC mAUs and concentration units. When
mAU’s are selected, the Interval field
will always be
0.0 - 9999.9 (The mAU information is
typically used for troubleshooting).
F7: NEXT RULE Does not appear on the patient results Used to change the Rule field
display. selection. There are 7 possible rule
selections, 6 of which are
Shewhart Rules. See “Rules Field
Definitions” on page 40 of this
chapter.
F8: PRINT Used to print out results information Same as patient results.
appearing at the top of the screen using
the system printer. (This does not print
to an external printer).
1. Select F8: PRINT.
2. Answer the prompt with a Y to print
out only the information listed at the
top of the screen, or with an N to
print out a report that contains all the
individual results in that method’s
test results buffer on this instrument.
3. Select ENTER.
Rules Field Definitions

All but the first field definition listed below are “Shewhart Rules,” by which the
results are examined in several ways to determine if the overall system is in
control.
4 - 40
When a new rule is selected, the Interval, In, and Out fields are updated
automatically to reflect the new rule selected.
Table 4-21: Method Review Screen Function Keys
Rule field Meaning
High/Low Interval Any result that falls outside the range listed on the Quality Control Ranges
screen for that fluid.
any point > 2 sd Any result that falls outside ±2 standard deviations from the mean. This is
termed a “warning” rule and requires further evaluation to judge whether
the data presents a problem.
any point > 3 sd Any result that falls outside ±3 standard deviations from the mean. A
violation of this rule suggests systematic error.
two consecutive > 2 sd Two consecutive results that fall outside ±2 standard deviations from the
mean. A violation of this rule suggests systematic error.
four consecutive > 1 sd Four consecutive results that fall outside ±1 standard deviation from the
mean. A violation of this rule suggests systematic error.
two consecutive > 4 sd The absolute difference between two consecutive results is greater than
or equal to 4 standard deviations. A violation of this rule suggests random
error.
ten consecutive Ten consecutive results above or below the mean. An above/below mean
violation of this rule suggests systematic error.
Note: These rules use the expected mean and SD values, unless
actual mean and SD values are entered. If entered, the actual
values are used to create the plots. These rules consider only
results “within” a given material and not across materials. To
review results across materials, print out a plot of both levels
and then visually examine them.
4 - 41
Reviewing QC Results
Any deleted results are not included in or used to calculate the values in the
fields at the top of a Method Review QC screen. These results are not
permanently deleted from the QC test result buffer.
Note: Patient results cannot be deleted.
Deleting a Result Using the Results Listing Screen

1. Move the cursor to the result and select F2: DELETE RESULT.
Note: An asterisk (*) on the screen indicates that the result is now
deleted.
2. To undelete a deleted result, move the cursor to the result and select
F2: UN-DELETE.
Deleting a Result Using the L-J Plot

1. Use the arrow keys to move the marker onto the result and then select
F2: DELETE RESULT.
Note: A yellow asterisk (*) appears on the screen to indicate that
the result is now deleted.
2. To undelete a deleted result, move the cursor to the result and select
F2: UN-DELETE.
Note: When a result is un-deleted, it is compared against the
current rule in the Rule field and becomes a red x or a green +
accordingly.
Connection Between the QC Results Listing Screen and QC L-J Plot

View
Any deleted/undeleted result made on the Results Listing screen is also
deleted/undeleted on the L-J plot view and vice versa.
The result appears on the Results Listing screen with an asterisk (*) in the far
left column to indicate that it has been deleted. If the deleted result also
exceeds the current rule shown on the display, a > displays in the left column.
If the result is lower than the current rule, a < displays in the left column.
A deleted result is not used in any of the calculations shown at the top of the
screen. Therefore, when a result is deleted, the Tests, In, Out, Actual Mean,
Actual SD, and % CV fields all change accordingly.
4 - 42
Dimension EXL with LM/EXL 200 System Operator’s Guide Maintenance
Chapter 5: Maintenance
5-1
Maintenance Dimension EXL with LM/EXL 200 System Operator’s Guide
General Instrument Care and Cleaning

The instrument and areas around it should be kept clean based on guidelines
set forth by the Department of Labor (OSHA) 29 CFP 1910.1030, Occupational
Exposure to Blood and Pathogens: Final Rule.
Routinely clean the outside surfaces of the entire Dimension EXL integrated
chemistry system using a cloth dampened with warm, soapy water.
Instrument surfaces can be cleaned with a 10% bleach solution.
Materials Used for Cleaning
Undiluted Bleach
All references to “undiluted bleach” in this guide refer to a product that meets
the following criteria:
• 5-12% sodium hypochlorite
• No additives
• No detergents
• No surfactants
• No fragrances
• Minimal impurities
Bleach Solutions
Note: All bleach solutions should be prepared fresh prior to use.
All references to a bleach solution, refer to a solution that is made by diluting
an undiluted bleach product that meets the criteria listed above with water.
Sodium Hydroxide Solutions

When 0.1N sodium hydroxide solution is required, use a dedicated bottle of
Reagent Probe Cleaner (Cat. No. RD 702) or prepare a 0.1N NaOH solution.
Decontamination
Decontaminate surfaces in or on the instrument where biohazard material has
spilled.
1. With the system in standby, select PAUSE.
2. Lift the instrument lid.
3. Locate the spill.
4. Decontaminate the area using a 10% bleach solution.
5. Thoroughly dry the decontaminated area using a lint-free cloth.
6. Close the lid, if necessary.
7. Select PAUSE, and then select RESET.
5-2
Opening the Reagent Lid

The reagent lid is the large lid covering the reagent area. To open this lid,
release the safety latch as follows:
1. Raise the IMT lid.
2. Insert a long slender tool such as a screwdriver into the reagent lid latch.
3. Press firmly and raise the lid.
WARNING: Ensure that all lids are fully open to avoid injury while
performing maintenance.
WARNING: During diagnostics, modules are moving. Be aware of moving

parts while performing maintenance.
Figure 5-1: Reagent Lid
Opening the LOCI Access Lid

The LOCI access door is located behind the instrument. To gain access, open
the LOCI access door while standing behind the instrument. Use a T-30- Torx
wrench to loosen the captive screw securing the LOCI access door.
Figure 5-2: LOCI Access Lid
5-3
Removing the HM Incubation Wheel Cover

The HM incubation wheel cover improves the temperature stability of the HM
incubation area.
1. Remove the HM wash probe clear plastic shield by loosening the flat
head screws located on the right side of the HM wash pump.
2. Grasp the incubate wheel cover by the tabs on top and pull up being
careful not to damage the HM wash probes, or the vessel transfer ribbon
cable.
3. Pull cover out away from wheel and set aside.
4. Reverse steps to reinstall making sure to align the three tabs.
Figure 5-3: HM Incubation Wheel Cover
5-4
Weekly Maintenance

Only trained operators should perform this procedure.
Cleaning HM Wash Probes and the R2 Reagent Probe

Note: Perform this task using cotton swabs, 0.1N sodium hydroxide
solution and water.
Cleaning the HM Wash Probe
Clean the HM wash station probes and the R2 reagent arm probe weekly to
remove any residue.
1. With the instrument in standby, select F4: SYSTEM PREP >
F7: PUMP PRIME > F6: HM.
Note: Navigating to the HM Pump Prime screen prevents any
automatic priming of the HM wash probes. This is also the
correct screen to prime the probes later in this procedure.
3. Use a moist cotton swab dipped in water and beginning at the top of the
probe, wipe down the outside of both HM wash probes.
Figure 5-4: Cotton Swab
5-5
Cleaning the R2 Reagent Probe

1. Turn the splined shaft on the R2 reagent arm until the R2 probe rises out
of the R2 reagent drain.
2. Move the arm counterclockwise until the R2 probe can be accessed.
Figure 5-5: Splined Shaft
3. Use a cotton swab dipped in 0.1N sodium hydroxide and scrub the nut at
the top of the probe.
4. Beginning at the top, wipe down the outside of the R2 reagent probe.
5-6
Figure 5-6: Reagent Probe
Note: If a bottle of reagent probe cleaner is used for 0.1N sodium

hydroxide in this procedure, do not use that bottle on the
instrument. Use it only for weekly cleaning fo the R2 probe.
5. Select F1: HM WASH PUMP to prime the HM wash pumps.
6. Record completion of this procedure. Refer to the section titled “Using
the Instrument Log Screen” in Chapter 2.
5-7
Monthly Maintenance

WARNING: Only trained operators should perform these procedures.

The seven monthly maintenance procedures are:
• Cleaning the Clot Check Drain on the IMT Port
• Replacing IMT Pump Tubing
• Cleaning the IMT System
• Replacing Instrument Air Filters
• Styletting HM Wash Probes
• Replacing HM Pump Heads on wash station
• Cleaning the R1, R2 and R3 (if RMS equipped) Drains
Note: The replacement procedures use tools and commonly
replaced parts that are provided in the Accessory Spare Parts
kit. After using a spare part from this kit, be sure to order a
new one from Siemens Healthcare Diagnostics.
Cleaning the Clot Check Drain on the IMT Port

Note: Perform this procedure using undiluted bleach, water and a
disposable pipette.
3. Access the clot check drain.
4. Dispense approximately 1mL of undiluted bleach into the clot check
drain 10 times.
Note: Allow the clot check drain to empty itself before each
subsequent addition.
5-8
Figure 5-7: Clot Check Drain
5. Dispense approximately 1mL of water into the Clot Check drain 10 times.
Note: Allow the port to empty itself before each subsequent
addition.
5-9
Replacing IMT Pump Tubing

Note: Perform this procedure using the Indirect IMT Pump Tubing
kit.
3. Select F4: SYSTEM PREP > F3: IMT > F3: ALIGN/PRIME.
4. Use the fluidics label on the instrument to locate IMT pump tubing X
around the IMT peristaltic pump.
5. Turn and remove the pressure plates foot bar.
6. Open the pressure plates.
7. Remove and replace tubing X which is located around the top of the
pump. Pull to fit the end of the tubing in place.
WARNING: IMT pump tubing X is a biohazard. Follow laboratory specific

safe biohazard waste disposal procedures when discarding
this tubing.
Figure 5-8: IMT Pump Tubing
# Description
1 Pressure Plates Foot Bar
2 X2 Tubing
3 X Tubing
4 Pressure Plates
Note: Do not use the bottom tube position on the pump. The X
tubing goes around the top position of the pump and
connects to the straight (top) portion of the IMT pump.
8. Close the pressure plates.
5 - 10
9. Reinsert the pressure plates foot bar and turn it to lock in the pressure
plates.
10. Select PAUSE to restart the sampling system.
11. Select F1: PRIME SALT BRIDGE solution.
12. Prime with Salt Bridge solution until the solution exits the IMT sensor and
is visible in the X2 tubing.
13. Select HOME on the touchscreen or press SHIFT+ EXIT.
Note: The system performs an IMT pump alignment and IMT
calibration.
Cleaning the IMT System

Clean the IMT System monthly if fewer than 100 IMT tests per day are run.
Clean the IMT System every 15 days or other appropriate interval if more than
100 IMT tests per day are run.
Note: Complete this procedure using paper towels, undiluted
bleach, serum or plasma, disposable pipettes, water and the
QuikLYTE Integrated multisensor.
1. With the instrument in standby, select F4: SYSTEM PREP >
F3: IMT > F8: IMT SYS CLEAN.
2. Select F3: OPEN PORT.
3. Dispense approximately 1mL of undiluted bleach into the IMT port 10
times.
addition.
4. Dispense approximately 1mL of water into the IMT port 10 times.
addition.
5. Select F3: CLOSE PORT.
6. Fill the port with undiluted bleach.
7. Select F8: START SOAK.
Note: The fluid sits inside the tubing for two minutes. When the
soak is complete, the system primes Standard A.
8. Fill the port with fresh serum or plasma free of hemolysis, icterus or
lipemia.
9. Select F8: START SOAK.
Note: The fluid sits inside the tubing for two minutes. When the
soak is complete, the system primes Standard A.
10. Select F7: CHANGE SENSOR.
5 - 11
CAUTION: Replace the QuikLYTE sensor after bleaching the IMT system.
11. Replace the QuikLYTE Integrated Multisensor. See “Replacing the
QuikLYTE Integrated Multisensor” on page 24 of System Operation.
12. After changing the QuikLYTE sensor, close the IMT lid.
Replacing Instrument Air Filters

1. Ensure the system is in standby mode, use Table 5-1 to locate and
replace each filter.
CAUTION: When installing these filters, make sure that the air flow arrows
on the frame of each filter are pointing as indicated in Table 5-1.
Table 5-1: Replacing Air Filters
Filter Replacement Procedure
Cabinet/Cuvette Ring This filter is located on the rear of the instrument.

1. Slide the filter up and out of its holder.
2. Insert the new filter with the air flow arrow pointing in toward the
instrument.
Figure 5-9: Cabinet Filter
Cabinet (non-RMS This filter is located on the rear of the instrument.

only) 1. Slide the filter up our of its holder and replace with the new filter.
The air flow on the new filter should point in towards the instrument.
Figure 5-10: Cabinet Filter (Non-RMS)
5 - 12
Cuvette Ring (Non This filter is located in the front right of the instrument panel.
RMS) 1. Open the right instrument cabinet panel.
2. Slide the filter out of it’s holder and replace with the new filter.
Figure 5-11: Cuvette Ring (Non-RMS)
Power Supply This filter is located below the card cage.

1. Open the left instrument door and locate the filter to the left of the
instrument power switch below the card cage.
2. Loosen the thumbscrew above the filter.
3. Remove the holding bracket.
4. Pull the filter out of its holder.
5. Insert the new filter with the air flow arrow pointing in toward the
instrument.
Figure 5-12: Power Supply Filter
5 - 13
Thermal Chamber This filter is located in the rear right corner of the instrument.
1. Pull the filter cover and filter off of the plastic frame. This filter does not
have any air flow arrows and cannot be installed backwards.
2. Discard the used filter.
Figure 5-13: Thermal Chamber Filter
2. Remove all dust from the used filter by washing with water and air drying
or by using a vacuum cleaner.
Note: All filters can be reused with the exception of the thermal
chamber filter, which must be replaced.
the Instrument Log Screens” in Chapter 2.
Styletting HM Wash Probes

Note: Complete this procedure using a screwdriver, IMT stylet, and
paper towels.
F4: SYSTEM PREP > F7: PUMP PRIME > F6: HM.
automatic priming of the HM wash probes that may occur.
This is also the correct screen to prime the probes later in this
procedure.
2. Raise the IMT & reagent lids and locate the wash probes.
3. Disconnect the aspirate tubing from the wash probes.
Table 5-2: Tubing
Tubing Color Number Detach from
Green 4 Wash Probe 1 aspirate (bent top) probe
Blue 2 Wash Probe 2 aspirate (bent top) probe
5 - 14
Figure 5-14: HM Wash Probe
# Description
1 Wash Probe Aspirate Tubing
2 Bottom Plastic Guard
4. Remove the plastic guard from the wash station by loosening the two
screws on the facing side until the guard can slide out from under the
screws.
5. Pass the IMT stylet through the aspirate probe of each wash station,
pulling the stylet out through the bottom of each probe to dislodge any
obstruction or accumulations.
WARNING: The beveled wash station probes are a biohazard and a

puncture hazard. Use laboratory safe biohazard procedures
for contact with these probes.
5 - 15
Figure 5-15: Wash Probe Diagram
# Description
1 Insert Stylet
2 Lip
3 Sleeve
4 Positioning Groove
5 Aspirate Probe
6 Dispense Probe
6. Dispose of the IMT stylet.
WARNING: This IMT stylet is a biohazard; follow laboratory specific

biohazard procedures for contact with this stylet.
7. Reconnect the tubing to the probes.

8. Reinstall the bottom plastic guard onto the wash station.
9. Select F1: HM WASH PUMP to prime the HM wash pump.
10. Close the instrument lids.
11. Perform a System Check.
5 - 16
Replacing the HM Pump Heads on Wash Station

F4: SYSTEM PREP > F7: PUMP PRIME > F6: HM.
2. Access the pump head to be replaced by raising the IMT and reagent lids.
Note: Only the HM pump heads on the wash station are required to
be replaced monthly.
Table 5-3: HM Pump Heads
Pump Heads Access
Wash Station The aspirate and dispense pump heads are located on the wash station frame.
Figure 5-16: Wash Pump
# Description
1 Pump Head Wash Pump 2
2 Pump Head Wash Pump 1
3. Disconnect the tubing from the pump head at its connectors.

4. Squeeze the two tabs on the edge of the pump head and pull it off of the
pump base and discard it.
5 - 17
WARNING: The pump head is a biohazard; use laboratory safe biohazard

waste disposal procedures when discarding.
Figure 5-17: Pump Head Tubing Tabs
5. Install the new pump head on the motor:

a. Insert the shipping plug (or “T”) that came with the pump head
completely into the front of the cassette.
b. Slide the pump head onto the shaft of the motor, allowing the
shipping plug to fall as the new pump head is installed.
c. Snap the pump head into place.
d. Reattach the tubing to the pump head.
CAUTION: The shipping plug (or “T”) must be inserted into the pump head
before installing onto the motor to prevent damage to the pump
rollers as the pump head is pushed onto the motor shaft.
6. Prime the HM wash pump.
a. Select F1: HM WASH PUMP.
b. Close all instrument lids.
c. Perform a System Check.
5 - 18
Cleaning the R1, R2 & R3 Drains

Note: Complete this procedure using undiluted bleach, a disposable
pipette and paper towel.
3. Turn the bottom gold colored splined shaft on the R2 reagent arm to
raise the reagent probe out of the reagent drain.
4. Move the R2 arm away from the drain by moving it counterclockwise.
WARNING: The R2 probe is a biohazard. Follow laboratory safe handling

procedures for contact with and disposal of this probe.
5. Remove the R1 Reagent Probe from the drain by turning the gold colored
splined shaft of the R1 Reagent arm.
6. Remove the R3 Reagent Probe from the drain by turning the gold colored
splined shaft of the R3 reagent arm.
7. Turn off vacuum to Dimension EXL system.
8. Select F7: DIAGNOSTICS > F1: ELECTRO MECHANICAL >
F6: WATERWORKS.
9. Select F4: VACUUM ON/OFF twice to turn vacuum off.
10. Clamp off non-labeled drain line directly at R1, R2 or R3 drains (if
installed) using hemostats.
11. Place a paper towel under the probe.
5 - 19
12. Insert the disposable pipette tip into the drain near to the bottom and
dispense the undiluted bleach into the drain unit until it is completely
filled with liquid.
Note: Sample probe cleaner can be used instead of bleach. Ensure
that a paper towel is around the drain to catch any overflow.
Note: Do not overflow the R1 drain. Significant overflow of liquid
from the R1 drain can destroy the photometer home sensor.
13. Remove the pipette.
14. Let bleach sit in drain for 5 minutes.
15. Un-clamp drain lines.
16. Select F4: VACUUM ON/OFF to turn system vacuum back on.
17. Go to Pump Prime screen and select F1: PRIME WATER (10x).
18. Close all instrument lids.
5 - 20
Other Maintenance
WARNING: Ensure that the lids are fully open to avoid injury while

Only trained operators should perform these procedures.
Accessory Spare Parts Kit

The replacement procedures use tools and commonly replaced parts that are
provided in the Accessory Spare Parts kit.
Lowering and Raising the Thermal Chamber

Occasionally the thermal chamber will need to be lowered and raised for
maintenance and troubleshooting.
Lowering the Thermal Chamber

1. With the system in standby, open the 2nd door from the right (RMS only)
or end door of the instrument and remove the cuvette waste container.
2. Place a screwdriver into the hole of the thermal chamber release bracket
and push the screwdriver down on the internal release plate until the
thermal chamber drops down completely.
CAUTION: Using a prying motion may cause damage to the release plate.
CAUTION: When lowering the thermal chamber, ensure the waste tubing on
top of the waste bottle is clear before lowering completely.
Figure 5-19: Release Thermal Chamber
5 - 21
Raising the Thermal Chamber

CAUTION: Do not raise the thermal chamber by lifting up on the plastic
components where the air hose connects to the thermal
chamber.
1. Lift up on the side or bottom of chamber until the thermal chamber
seats completely against the baseplate.
Figure 5-20: Thermal Chamber
2. The tape indicators should align indicating that the chamber is closed
completely (See Figure 5-21).
WARNING: If the thermal chamber is not completely closed, patient

results may be affected.
Figure 5-21: Completely Closed - Correct
5 - 22
Figure 5-22: Partially Closed - Incorrect
3. Adjust the tension in the cuvette film, if needed by:

a. Select F4: SYSTEM PREP > F6: SYS COUNTERS > F3: FILM LOAD >
F2: TENSION.
4. When tensioning is complete select F2: TENSION again if the film is not
taut.
Calibrating Cuvette System Temperature

Note: Perform this procedure using an annually calibrated digital
thermometer and a probe positioning sleeve.
Note: The instrument must be turned on for more than two hours
before a proper temperature calibration can be performed.
1. Select F4: SYSTEM PREP > F5: TEMP MONITOR.
2. Select F8: TEMP DIAG.
Note: The status may read: Ok, Open, or Short. This may help
determine the location of a problem area. Contact the
Customer Care Center - Technical Solution: Inside U.S.:
1-800-441-9250; Outside U.S. Refer to the local support
team.
3. Select F1: CHECK CUVETTE and answer the message that displays.
Note: Wait for the message to place the temperature probe in
position before continuing.
4. Slide the plastic probe positioning sleeve completely onto the digital
thermometer temperature probe.
Note: Ensure that the side labeled "XPAND-THIS SIDE UP" faces up.
5 - 23
Figure 5-23: Probe Positioning Sleeve

6. Place the digital thermometer probe in the fourth cuvette hole at the
sample access position.
7. Place the thermometer in the sample segment area.
Figure 5-24: IMT Lid Raised
Figure 5-25: Digital Thermometer
5 - 24
8. Close the IMT and reagent lids.

Note: Ensure that all instrument doors and panels are closed.
9. Wait until the cuvette Thermal Signal Acquisition Interval field counts
down to 0 and changes to YES.
a. If the cuvette temperature on the thermometer is between 32°C
and 42°C, continue with Step 10.
b. If it is outside this temperature range, do not enter the
temperature. Contact the Customer Care Center - Technical
Solution: Inside U.S.: 1-800-441-9250; Outside U.S. Refer to the
local support team.
10. Lift the IMT and reagent lids and remove the digital thermometer probe
and sleeve from the cuvette access hole.
12. Press SPACEBAR and wait until all the cuvette fields display YES.
13. Select F2: CALIB CUVETTE.
14. Enter the temperature from the digital thermometer.
15. Select ENTER.
16. The system makes cuvette thermal adjustments automatically.
17. Run QC.
Calibrating Reagent System Temperature

Note: Complete this procedure using a digital thermometer.
1. With the system in standby, select: F4: SYSTEM PREP >
F5: TEMP MONITOR.
2. Wait until the reagent Thermal Signal Acquisition Interval field displays
YES.
3. Select F5: CHECK REAGENT and answer the message that displays.
Note: Wait for the message to place the temperature probe in
position before continuing.
5. Place the digital thermometer probe in the reagent tray temperature
measurement hole.
5 - 25
Figure 5-26: Probe Hole
6. Close the reagent lid and ensure that all instrument doors and panels are
closed.
Figure 5-27: Digital Thermometer
7. Wait until the temperature on the digital thermometer equilibrates

(approximately 30 seconds).
Note: If all the reagent fields are also YES, read the temperature on
the digital thermometer.
a. If the reagent tray temperature on the thermometer is between
–2°C and 10°C, continue with Step 8.
b. If it is outside this temperature range, contact the Customer Care
Center - Technical Solution: Inside U.S.: 1-800-441-9250; Outside
U.S. Refer to the local support team.
8. Remove the digital thermometer probe from the reagent tray
temperature measurement hole.
10. Press SPACEBAR.
11. Select F6: CALIB REAGENT.
12. Enter the temperature from the digital thermometer and select ENTER.
5 - 26
13. Run QC.

Note: The system will now make reagent thermal adjustments
automatically.
Note: If the message The value entered is outside the allowed
calibration range displays and the temperature entered is
within the –2° C to 10° C temperature range, contact the
Customer Care Center - Technical Solution: Inside U.S.:
1-800-441-9250; Outside U.S. Refer to the local support
team.
Calibrating HM Temperature
Note: Complete this procedure using a digital thermometer.
Note: The system must be turned on for more than two hours
before a proper temperature calibration can be performed.
1. Select F4: SYSTEM PREP > F5: TEMP MONITOR.
2. Select F3: CHECK HM INCU and type Y in response to the system warm
up prompt.
3. When the message to place the temperature probe appears, raise the IMT
and reagent lids.
4. Place the digital thermometer probe in the temperature monitoring hole
of the HM thermal ring.
Note: This small hole is in the inside rim of the heater ring at the 6
o'clock position. The HM wheel cover has an arrow indicating
the position.
Figure 5-28: Temperature Probe
5 - 27
5. Wait three minutes for the temperature to equilibrate and then read the
temperature on the digital thermometer.
a. If the temperature is between 35° C -41°C, continue with Step 6.
b. If the temperature is outside this range, call the Customer Care
Center - Technical Solution: Inside U.S.: 1-800-441-9250; Outside
6. Remove the digital thermometer probe.
7. Select F4: CALIB HM INCU.
8. Enter the temperature from the digital thermometer and press ENTER.
9. Run QC.
Note: If the message “The value entered is outside the allowed
calibration range” displays and the temperature entered is
within the 35°C- 41.0°C temperature range, contact the
Customer Care Center: Inside U.S.: 1-800-441-9250; Outside
Cleaning Cuvette Windows

There are two procedures for cleaning cuvette windows:
• Cleaning all the cuvette windows
• Cleaning only the bad (dirty) cuvette windows
Figure 5-29: Cuvette Window
Follow the appropriate procedure for the required cleaning.
5 - 28
Cleaning All Windows

Note: Complete this procedure using needlenose pliers or window
extractor, lens paper, and water.
1. With the system in standby, raise the IMT and reagent lids.
2. Select F7: DIAGNOSTICS > F5: CHECK WINDOWS.
3. Set the Access field at the top of the screen to ACCESS ALL.
4. Select F1: START CLEAN.
5. When the message Clean and replace window, then press any key to
continue displays, remove the window that is in the window access
position on the cuvette ring.
Note: Use needlenose pliers or the cuvette window extractor tool to
remove the cuvette windows. See Installing & Removing
Cuvette windows on page 32.
6. Clean the window with lens paper (and water, if necessary) and reinstall
it.
7. If the window cannot be cleaned (or it is scratched or damaged), discard
the cuvette window and install a new window from the Accessory Spare
Parts kit.
Note: A window must be in each position on the cuvette ring. Use
replacements in the accessory spare parts kit. If no
replacements remain in the kit, put the damaged window
back in the instrument. Do not leave any empty hole in the
cuvette ring.
8. Press any key.
9. Wait for the message Clean and replace window, then press any key
to continue to display.
10. The system automatically advances nine window positions before the
message displays.
11. Remove, clean, and reinstall the window.
12. Press any key.
13. Repeat this step until all windows are cleaned.
14. When all the windows have been cleaned, and they have been
determined to be clean by the system, the message: All windows have
successfully passed QC displays and window QC ranges are printed.
15. Close the IMT and reagent lid.
16. Select HOME or SHIFT+EXIT to return to the Operating Menu.
17. Select RESET to initialize the system.
5 - 29
Cleaning Bad Windows

Note: Complete this procedure using needlenose pliers or the
cuvette extractor tool, lens paper and water.
2. Select F7: DIAGNOSTICS > F5: CHECK WINDOWS.
3. Set the access field at the top of the screen to ACCESS BAD.
4. Select F2: ACCESS MODE > F1: START CLEAN.
5. When the message: Clean and replace window, then press any key to
continue displays, remove the window that is in the window access
position on the cuvette ring.
Note: Use the needlenose pliers or using the cuvette window
extractor tool to remove the cuvette window.
6. Clean the window with lens paper (and water, if necessary) and reinstall
it.
7. If the window cannot be cleaned (or it is scratched or damaged), discard
the cuvette window and install a new window from the Accessory Spare
Parts kit.
Note: A window must be in each position on the cuvette ring.
Note: Use replacements in the accessory spare parts kit. If no
replacements remain in the kit, put the damaged window
back in the system. Do not leave any empty hole in the
cuvette ring.
8. Press any key to go to the next window.
9. When the message displays, remove the window and replace it.
10. After cleaning the first two windows, the system automatically checks all
the remaining windows and alerts when a window requires cleaning.
Note: If it is determined that any of these windows is damaged,
discard it and replace it with one from the accessory spare
parts kit.
11. When all the windows and have been cleaned and all the windows are
determined to be clean by the system, the message All windows have
successfully passed QC displays and window QC ranges are printed.
13. Select HOME or SHIFT+EXIT to return to the Operating Menu.
14. Select RESET to initialize the system.
5 - 30
Note: To configure custom window check limits, use the “Check Bad
Limit” field. Enter the limit for the software to use in
determining whether a window is acceptable to use. Values
in this field can be between 10 and 35. The default value is
15. (The lower the limit, the more the windows will require
cleaning during this check, but in general windows will need
to be cleaned less often). The system indicates windows that
do not meet the defined limit with red “x”s. These windows
will be presented for cleaning.
5 - 31
Removing and Installing Cuvette Windows

Removing Cuvette Windows
Table 5-4: Removing Cuvette Window
Tool Type Procedure
Needlenose Pliers Grasp the top of the cuvette window with the pliers and pull the window
straight up and out of the cuvette wheel.
Figure 5-30: Using Needlenose Pliers
Cuvette Extractor Tool 1. With the flat side of the extractor facing the cuvette ring, insert the
extractor straight down until it touches the top of the window.
2. Tilt the handle outward to grip the window and hold it in place. Pull the
extractor up to remove the window.
Figure 5-31: Using Cuvette Window Extractor Tool
5 - 32
Installing Cuvette Windows

Install the cuvette window with its top curved area facing outward and press it
completely into position
System processing problems can occur if a window is installed incorrectly.
Figure 5-32: Cuvette Window
5 - 33
Cleaning the IMT Waste Tubing

Note: Complete this procedure using undiluted bleach and a
sample cup.
2. Disconnect the waste tubing from the IMT peristaltic pump tubing.
WARNING: The waste tubing is a biohazard. Follow laboratory safe

handling procedures for contact with and disposal of this
tubing.
Figure 5-33: Disconnect Waste Tubing
# Description
1 Check Valve
2 Waste Tubing
3. Fill a sample cup with 1.5 mL of undiluted bleach.

4. Place the waste tubing into the sample cup.
Note: The bleach should be drawn out of the cup within 3–4
seconds. If it is not, repeat Step 3 with additional cups of
bleach until it does.
5 - 34
Figure 5-34: Clean Waste Tubing
5. Fill a sample cup with water and place the waste tubing in the cup to
flush any residual bleach from the waste line.
6. Connect the waste tubing to the IMT peristaltic pump tubing.
7. Close the IMT lid.
8. Calibrate the IMT.
Cleaning the Sample Probe and Drain

Note: Perform these procedures using the following tools and
supplies:
To clean the sample probe use undiluted bleach, and a
sample cup.
To clean the sample drain use 10% bleach solution and a
drain brush.
1. With the system in standby, select F4: SYSTEM PREP >
F6: SYS COUNTERS.
2. In the Pos: field of the Sample Probe line, enter the segment and cup
position where the 1.5 mL sample cup is placed.
3. Select ENTER.
4. Place the 1.5 mL sample cup of undiluted bleach in an adapter in that
segment position.
5. Select F4: CLEAN PROBE to begin the probe cleaning.
6. When the probe cleaning is finished, follow the prompt Wait until the
sample probe stops, then press the ENTER key.
7. After the prompt Manually clean sample probe drain displays, raise the
IMT and Reagent lids.
8. Dip the drain brush into a 10% bleach solution.
9. Insert the drain brush into the hole closest to the reagent tray and scrub
inside the drain.
5 - 35
WARNING: The drain brush is a biohazard. Use laboratory safe biohazard

waste disposal procedures when discarding this brush.
Figure 5-35: Drain Brush
10. Repeat Step 8 and Step 9 three times.

Note: Do not push the sample probe into the drain tubing.
11. Follow the prompt Remove cup from segment position then press any
key.
13. Select RESET.
5 - 36
Cleaning the Water Bottle

Note: Perform this procedure using 10% bleach solution and spare
water bottle.
Note: If the water bottle is periodically changed, use the following
procedure to clean the used water bottle.
1. Fill the used water bottle with a 10% bleach solution.
2. Let the solution stand in the bottle at least one hour.
3. Thoroughly rinse the bottle out and then allow it to air dry.
4. Cover the top of the bottle and store the bottle until the water bottle is
replaced again.
Replacing the Cuvette Diaphragm
Note: Complete this procedure using the diaphragm (included with
the film canister).
2. Select F4: SYSTEM PREP > F6: SYS COUNTERS >
F2: DIAPH CHANGE.
3. Locate the cuvette diaphragm.
Figure 5-36: Cuvette Diaphragm
4. Raise the barcode reader and unscrew the alignment bar thumbscrew.
5. Raise the alignment bar out of the way.
5 - 37
WARNING: All components in the cuvette manufacturing area can be

extremely HOT. Wait at least five minutes for the components
in this area to cool before continuing with this procedure.
Figure 5-37: Barcode Reader and Thumb Screw on Alignment Bar
# Description
1 Barcode Reader
2 Thumbscrew
6. Unlock the U-seal solenoid assembly by pulling its curved locking bar to
the right.
7. Move the assembly to the left and out of the way.
5 - 38
Figure 5-38: Curved Locking Bar
# Description
1 Cuvette Formation Assembly Arm
2 Curved Locking Bar
3 U-Seal Solenoid
8. Pull the cuvette formation assembly arm away from the cuvette ring.
9. Remove the used cuvette diaphragm by lifting an edge and pulling it up
off the heat torch.
5 - 39
CAUTION: Do not pull the soft tip out of position while replacing the
diaphragm.
10. Install the new cuvette diaphragm.
Note: The circular hole should be toward the bottom of the heat
torch with the U-shaped notches facing outward. Ensure the
diaphragm is pushed down completely.
Figure 5-40: New Cuvette Diaphragm
11. Push the cuvette formation assembly back into position next to the
cuvette ring.
12. Put the U-seal solenoid assembly in its original position and lock it in
place with the curved bar.
13. Position the alignment bar and tighten its screw.
14. Lower the barcode reader.
15. Press any key. When the prompt Do you want to store the NEW system
information? (y/n) displays, type Y to update the System Counters
screen.
16. Close the reagent and IMT lids.
5 - 40
Replacing the Cuvette Film Cartridge

F6: SYS COUNTERS > F3: FILM LOAD.
2. Open the cabinet doors and remove the waste container. See “Cuvette
Film Diagram” on page 23 of Appendix.
3. Use scissors to cut the right and left film strips on the used cuvette
cartridge between the cartridge and the baseplate.
Note: Leave at least six inches of film hanging from the system.
Figure 5-41: Cuvette Film Cartridge
4. Slide the used cartridge off the film holder and discard it.
5. Remove the red plastic key from the center of the new cartridge by
pulling up on its ring.
5 - 41
Figure 5-42: Anti-Rotation Key
Note: Place the extra diaphragms in the Accessory Spare Parts Kit.
6. Slide the new cartridge onto the film holder.
Note: Ensure the new canister is completely seated onto the film
holder.
7. Pull the left film strip out of the cartridge. Overlap it about 1/2” inch over
the left strip of old film hanging from the system and align the sides of
these two film strips.
8. Use the red tape from the new cartridge to tape these strips together.
Repeat the overlapping, aligning and taping with the right strip of film.
Note: If the red tape is damaged or unusable, use transparent tape.
This tape must be applied to both the front and rear of the
film strips to ensure that they do not separate when pulled
through the instrument.
5 - 42
Figure 5-43: Correct Film Strip
# Description
1 Film
2 Tape (If using transparent tape, apply two

pieces, one on front and one on rear of
film strips)
3 1/2” Overlap of Film Strips
4 Film
Figure 5-44: Incorrect Film Strip
# Description
1 Do not let tape extend beyond

the edge of the film.
2 Do not wrap tape around film.
5 - 43
9. Select F1: LOAD FILM.

Note: Wait for the counter to reset to 12,000 and for movement to
stop.
10. After film loading is complete, check to see that there is no slack in the
film coming out of the cuvette film cartridge.
11. If there is, select F2: TENSION.
12. Insert the waste container and close the cabinet door.
5 - 44
Replacing the Cuvette Formation Spring, Tip, and E-Clip

Note: Complete this procedure using a screwdriver and needlenose
pliers.
2. Select F7: DIAGNOSTICS > F1: ELECTRO/MECH > F4: CUVETTE.
3. Select F4: U-SEAL SOLENOID twice to de-energize the U-Seal Solenoid.
Note: The large, flat, round plate on the end of the solenoid valve
moves away (de-energizes) from the rounded portion of the
valve, and may release air as it de-energizes.
4. Raise the barcode reader.
5. Unscrew the alignment bar thumbscrew and raise the alignment bar.

Figure 5-45: Barcode Reader and Thumb Screw on Alignment Bar
# Description
1 Barcode Reader
2 Alignment Bar Thumbscrew
6. Move the assembly to the left away from the cuvette ring.
5 - 45
# Description
3 U-Seal Solenoid
the right.
8. Pull the spring toward the form plunger head and separate it from the
E-ring.
9. Move the E-ring and plunger shaft slightly toward the spring (but still
separate from the spring).
10. Use the needlenose pliers to pull out the E-ring.
5 - 46
Figure 5-47: E-Ring
# Description
1 Plunger Shaft
2 Cuvette Diaphragm
3 E-ring
11. Remove the cuvette diaphragm by lifting an edge and pulling it up off the
heat torch.
12. Remove the plunger shaft and tip from the form block.
Figure 5-48: Plunger Shaft
13. If only the spring needs replacing, skip to Step 15. Otherwise, remove the
old soft tip from the plunger head.
Note: If the tip is broken, be sure to remove the remaining part of
the tip. Do not scratch the plunger head.
5 - 47
14. Install a new rubber tip on the plunger head.

Note: Ensure the bottom of the rubber tip is flush with the plunger
head. The bump on the rubber tip should rest in the small
cavity inside the metal plunger slot. If it does not, use a small
screwdriver to push it into position as shown below. Skip to
Step 21.
Figure 5-49: Plunger Head
# Description
1 Plunger Head (Pictured Upside Down)
2 Rubber Tip
15. Remove the old spring and place a new spring in the middle of the form
block.
16. Install the plunger shaft.
17. Push the spring toward the plunger head and away from the groove on
the shaft.
18. Push the plunger forward slightly to expose the groove.
19. Install the E-ring, making sure not to crush the spring.
20. Replace the cuvette diaphragm. See “Replacing the Cuvette Diaphragm”
21. Reposition the U-seal solenoid near the cuvette ring and push the curved
locking bar into place.
22. Position the alignment bar and tighten its thumbscrew.
25. Enter 20 and select ENTER.
26. Select F1: CYCLE to make 20 cuvettes.
5 - 48
Replacing the Cuvette Ring Sensor

Note: Complete this procedure using a screwdriver.
1. Power down the system. See “Performing a Controlled Power Shutdown”
on page 10 of Appendix.
3. Open the cabinet doors and remove the cuvette waste container.
4. Lower the thermal chamber. Refer to the procedure “Lowering and
Raising the Thermal Chamber” on page 21 of this chapter.
5. Locate the cuvette ring sensor.
Figure 5-50: Cuvette Ring Sensor
6. Grip the sensor firmly and pull it straight down off its spring clip and post
and then disconnect P/J 32B.
7. Install the new cuvette ring sensor.
Note: Push the sensor completely up until it snaps into place.
8. Raise the thermal chamber.
9. Restore power to the system following “Restoring Power After a
Controlled Shutdown” on page 10 of Appendix
5 - 49
10. Perform the “Cuvette Ring Alignment” on page 5 of Alignments. Perform

Step 3 through Step 4 of the procedure: “Photometer Alignment ” on
page 17 of Alignments.
11. Raise the thermal chamber and close all lids.
Replacing the Flex Loader Home Sensor

Note: Complete this procedure using a screwdriver, 5/32 Allen
wrench and a 5/64 Allen wrench.
3. Locate the Flex loader home sensor.
4. Using the 5/32 Allen wrench, loosen the screw holding the small black
metal shield that covers the sensor.
Figure 5-52: Home Position Sensor
5. Slide the bracket up and remove it.

6. Disconnect sensor connector P/J 22B.
7. Use the 5/64 Allen wrench to remove the screw that secures the sensor
to the system.
8. Install the new home sensor by reversing the previous steps.
9. Slide the bracket into position and tighten its holding screw.
5 - 50
Replacing the Flex Presence Sensor Board

Note: Complete this procedure using a 3/32 Allen wrench, 1/4 open
Allen wrench and a screwdriver.
3. Locate the sensor to the left of the reagent cartridge loader.
Figure 5-53: Presence Sensor Board
# Description
1 Hexagonal Standoff
2 Flex Presence Sensor Board
4. Using the 1/4 open-end wrench, remove the hexagonal standoff.

5. Disconnect the Flex presence sensor connector, P/J 22C.
6. Using the 3/32 Allen wrench, remove the screw from the sensor board.
7. Remove the sensor and the small plastic spacer.
8. Install the new sensor by reversing the previous steps.
Note: Ensure to install the hexagonal standoff and to install the
small plastic spacer between the sensor and the system
frame.
9. Close the reagent and IMT lids and select PAUSE to restart the sampling
system.
5 - 51
Replacing Fuses
Replacing AC Fuses
The AC fuse panel is located on the left side of the instrument.
2. Lift the printer shelf.
3. Using a screwdriver, turn the fuse holder to the left (counterclockwise) to
release the fuse from the instrument.
Figure 5-54: Fuse Panel
5 - 52
4. Replace the fuse with a fuse of the same voltage/amperage rating.

The amperage is printed above the fuse holder.
Note: AC fuses are numbered from right to left on the faceplate.
The amperages are:
Table 5-5: AC Fuse Chart
Fuse Amperage Description
F1 0.5 Card Cage Fans
F2 1.6 Thermal Chamber Fan
F3 0.5 Rear Panel Fans
F4 1.6 Waste Pump
F5 6.3 Refrigerator Compressor
F6 1.6 Refrigerator Solenoid
F7 3.15 Vacuum Pump
F8 1.6 Air Compressor
F9 1.6 Instrument Cabinet Fan

Controlled Shutdown” on page 10 of Appendix.
Replacing DC Fuses
2. Open the left front cabinet door. Locate the two vertical rows of fuses on
the card cage.
Figure 5-55: DC Fuses
3. Using a screwdriver, turn the fuse holder to the left (counterclockwise) to

release the fuse from the instrument.
5 - 53
4. Replace the fuse with a fuse of the same voltage/amperage rating.

Note: The voltage is printed to the left of the fuse holder. The
amperage is printed to the right of the fuse holder.
Replacing the Heat Torch Assembly

Note: Complete this procedure using a 3/22 Allen wrench and a
screwdriver.
3. Raise the reagent and Flex bar code reader out of the way, unscrew the
alignment bar thumbscrew and raise the alignment bar out of the way.

Figure 5-56: Barcode Reader and Thumb Screw Alignment Bar
# Description
1 Barcode Reader
2 Alignment Bar Thumbscrew
the right.
5. Move this assembly to the left and out of the way.
5 - 54
# Description
3 U-Seal Solenoid
6. Pull the cuvette formation assembly away from the cuvette ring.
5 - 55
7. Locate and disconnect P/J 13K.

Figure 5-58: P/J 13 K
# Description
1 Cuvette Nozzle Diaphragm
2 Screw
3 Compressed Air Manifold
4 P/J13K
8. Remove the cuvette nozzle diaphragm.

9. Remove the air manifold screw using the 3/32 Allen wrench.
10. Pull the compressed air manifold out of the heat torch.
11. Remove the screw that holds the heat torch assembly.
12. Remove the heat torch assembly from the instrument.
5 - 56
Figure 5-59: Torch Assembly
# Description
1 Screw
2 Assembly Removed
13. Install the new heat torch assembly by reversing the previous steps.
Note: The circular holes should face toward the bottom of the
cuvette diaphragm. The u-shaped notches should face
forward. Be sure the diaphragm is pushed down completely.
15. Close all lids.
5 - 57
Replacing the HM Incubate Wheel or Wash Wheel Home

Sensor
Note: Complete this procedure using a 9/64 T-handle Allen wrench
and a screwdriver.
3. Using a screwdriver, remove the bottom plastic guard from the wash
station.
Note: The two screws on the guard only need to be loosened until
the guard can be slid from underneath them.
4. Remove the HM wheel cover.
5. Remove and discard all reaction vessels from the wash and incubate
wheels.
WARNING: All reaction vessels removed from the wash wheel and
incubate wheel are biohazards. Dispose of them according to
your laboratory’s safe biohazard disposal procedures.
5 - 58
6. Unscrew the wash wheel locking knob and then use the knob to lift the
wash wheel out of the instrument.
Figure 5-60: HM Tower
# Description
1 Wash Probe Tubing
2 Probe Thumbscrew
3 Wash Wheel Locking Knob
4 Wash Wheel
5 Incubate Wheel
7. Lift the incubate wheel out of the instrument.

8. Using a 9/64 T-handle allen wrench, remove the three screws that hold
the magnet ring in the instrument.
9. Lift the magnet ring out of the instrument.
5 - 59
Figure 5-61: Magnet Ring
# Description
1 Magnet Ring Screws
2 Bracket Screw Wash Wheel Home Sensor
3 Bracket Screw Incubate Wheel Home

Sensor
10. Using a screwdriver, remove the sensor bracket screw.

11. Lift the sensor up until its electrical connector (P/J 41B for the incubate
wheel home sensor; P/J 42B for the wash wheel home sensor) can be
disconnected.
12. Remove the sensor and bracket from the instrument.
13. Using a screwdriver, remove one screw to remove the sensor from the
bracket.
14. Install the new sensor:
a. Position the new sensor onto the bracket.
b. Connect the sensor electrical connector and reinsert and tighten
the sensor bracket screw.
c. Position the magnet ring in the instrument. Insert and tighten the
three screws.
d. Place any of the three alignment cutouts in the incubate wheel
onto the incubate wheel alignment pin.
e. Place any of the three alignment holes in the wash wheel onto the
wash wheel alignment pin and push the wash wheel onto the
instrument.
f. Tighten the wash wheel locking knob.
g. Replace the HM wheel cover.
h. Reinstall the plastic guard onto the wash station.
i. Close all lids.
5 - 60

16. Perform all the alignment procedures in “HM Module Alignments” on
page 7 of Alignments.
Replacing the Probe Cleaner Pump Head

F7: PUMP PRIME > F6: HM.
2. Open the front cabinet doors and the pump panel. The probe cleaner
pump heads are located on the top left side on the back of the pump
panel assembly.
Figure 5-62: Probe Cleaner
# Description
1 Pump Head Reagent Probe Cleaner
2 Pump Head Sample Probe Cleaner
3. Disconnect the tubing from the pump head at its connectors.

4. Using your fingers, squeeze the two tabs on the edge of the pump head
and pull it off of the pump base and discard it.
5 - 61
WARNING: The pump head is a biohazard; follow safe laboratory

biohazard waste disposal procedures when discarding.
Figure 5-63: Pump Head Tubing Tabs
5. Install the new pump head on the motor:

completely into the front of the cassette.
b. Slide the pump head onto the shaft of the motor, allowing the
shipping plug to fall as the new pump head is installed.
c. Snap the pump head into place.
d. Reattach the tubing to the pump head.
CAUTION: The shipping plug (or “T”) must be inserted into the pump head
6. Prime the fluid for the pump of the pump head that was replaced.
a. Type the number 3 in the CYCLES field.
b. Select ENTER.
c. Select the appropriate function key for the fluid: F1: HM Wash
Pump.
Replacing the HM Pump and Motor Assembly

Note: Complete this procedure using a screwdriver and a 3/32 Allen
wrench.
5 - 62
2. Access the pump and motor to be replaced.

Table 5-6: Pump Head Assembly
Pump Head/Motor To Access
Figure 5-64: Wash Station Raise the IMT lid and reagent lids.
1. Pump Head Wash Pump #2

2. Pump Head Wash Pump #1
Figure 5-65: Pump Panel Open the front cabinet doors and acess the
pump panel.
1. Pump Head Reagent Probe Cleaner

2. Pump Head Sample Probe Cleaner
Note: See “HM Wash Diagram” in Appendix.
5 - 63
3. Disconnect the top and bottom tubing from the pump head at its
connectors.
Table 5-7: Pump Head/Motor, Connector and Tubing Identification
Pump Head/Motor Connector Tubing Identification
Wash Station Pump Head #1 Top Tubing 4 (green) to wash probe #1

Bottom To Chemistry Waste container
Wash Station Pump Head #2 Top Tubing 2 (blue) to wash probe #2

Bottom To Chemistry Waste container
Pump Panel (Right Pump) Top To Sample Drain

Bottom To Sample Probe Cleaner bottle
Pump Panel (Left Pump) Top To R2 Drain

Bottom To Probe Cleaner bottle (reagent)
4. Disconnect the motor electrical connector.

5. Remove the two screws that hold the pump and motor assembly using
the following methods.
a. Use a 3/32 Allen wrench for the assembly on the wash station.
b. Use a screwdriver for the assembly on the pump panel.
WARNING: The pump head is a biohazard; follow safe laboratory

Figure 5-66: Probe Cleaner Pump Screws
Note: Screws to remove a wash station pump and motor assembly

are in a similar location on the wash station.
5 - 64
6. Attach the new pump head to the new motor.

completely into the front of the pump head.
b. Slide the pump head onto the shaft of the motor.
c. Reattach the tubing to the pump head.
CAUTION: The shipping plug (“T”) must be inserted into the pump head
7. Install the new HM pump and motor assembly.
a. Insert and tighten two screws.
b. Connect the motor electrical connector.
c. Connect the tubing to the pump head.
9. Prime the pump on the assembly that was replaced.
a. Select F4 SYSTEM PREP > F7: PUMP PRIME > F6: HM.
b. Type the number 3 in the CYCLES field.
c. Select ENTER.
d. Prime the pump and motor assembly that was replaced by pressing
on one of the following:
• F1: HM WASH PUMP (chemistry wash)
• F2: REAG CLEANER (reagent cleaner)
• F3: SAMP CLEANER (sample cleaner)
Note: If the wash station pump or motor assembly was replaced,
prime the chemistry wash. If the left pump motor assembly
on the pump panel was replaced, prime the reagent cleaner.
If the right pump motor assembly on the pump panel was
replaced, prime the sample cleaner.
5 - 65
Replacing an HM Wash Probe

1. With the system in standby, select F4: SYSTEM PREP > F7: PUMP PRIME
> F6: HM.
3. Disconnect the tubing from the wash probe.
Figure 5-67: HM Tower Wash Probe
# Description
1 Wash Probe Tubing
2 Probe Thumbscrew
4. Loosen the probe thumbscrew until the probe can be lifted up and out of
the wash station.
5. Discard the probe.
5 - 66
WARNING: These beveled wash station probes are a biohazard and a

puncture hazard. Follow laboratory specific safe biohazard
waste disposal procedures for disposal of these probes in a
sharps container.
6. Position the new wash probe in the wash station so that its dispense
probe is toward the front edge of the wash station.
Note: Gently push the probe all the way down until its lip contacts
the probe holder.
Figure 5-68: Probe
# Description
1 Insert Stylet
2 Lip
3 Sleeve
4 Positioning Groove
5 Aspirate Probe
6 Dispense Probe
Note: When the probe is inserted properly, the positioning groove

on the probe ensures that the probe lip contacts its holder in
the wash station.
7. Tighten the probe thumbscrew.
8. Connect the tubing to the new probe.
5 - 67
9. Select F1: HM Wash Pump to prime the wash station pumps.

Table 5-8: Wash Probe Attachment Chart
Tubing Color Number Attaches to
Red 3 Wash Probe 1 dispense (straight top) probe.
Green 4 Wash Probe 1 aspirate (bent top) probe.
Yellow 1 Wash Probe 2 dispense (straight top) probe.
Blue 2 Wash Probe 2 aspirate (bent top) probe.
10. Align the wash probe to the wash wheel by completing the following
steps:
a. Select F7: DIAGNOSTICS > F3: ALIGNMENTS > F6: HM MODULE.
b. Move the cursor to the Wash Probes to Wash Wheel field.
c. Select F7: CHECK ALIGN.
Replacing the HM Wash Probe Home Sensor

Note: Complete this procedure using a 5/64 Allen wrench and a
screwdriver.
3. Push the wash probe platform down until the wash probe home sensor
can be accessed.
5 - 68
Figure 5-69: Wash Probe Home Sensor
# Description
1 Wash Probe Home Sensor
2 Wash Probe Elevator
4. Using a flat blade screwdriver, remove the two screws that hold the
vacuum sensor tower to the station.
5 - 69
Figure 5-70: Vacuum Sensor
5. Set the vacuum sensor tower to the side of the wash station as shown by
allowing it to hang.
CAUTION: Use caution when setting the tower aside so as not to disconnect
any tubing or electrical connections.
5 - 70
6. Using a 5/64 Allen wrench, remove the screw that holds the wash probe
home sensor in the system.
7. Disconnect electrical connector P/J 45B.
8. Remove the sensor from the instrument.
9. Install the new wash probe home sensor.
10. Reconnect P/J 45B and reinstall the vacuum sensor tower.
12. Align the wash probes to the wash wheel by completing the steps as
found in the procedure“Aligning the Wash Probes to the Wash Wheel” on
page 9 of Chapter 6 Alignments.
Replacing HM Wash Probe Tubing

1. With the system in standby, select: F4: SYSTEM PREP > F7: PUMP PRIME
> F6: HM.
3. Disconnect and discard the following pieces of tubing:
WARNING: These pieces of tubing are biohazards. Follow safe laboratory

Table 5-9: Tubing Wrap
Color Number Attachment
Yellow 1 Wash Probe 2 dispense (straight top) probe
Blue 2 (long) WP 2 vacuum sensor and wash pump 2 (top pump)
Blue 2 (short) Wash Probe 2 aspirate (bent top) probe and vacuum sensor
Red 3 Wash Probe 1 dispense (straight top) probe
Green 4 (long) WP 1 vacuum sensor and wash pump 1 (bottom pump)
Green 4 (short) Wash Probe 1 aspirate (bent top) probe and vacuum sensor
4. Install the new tubing.
5 - 71
5. Select F1: HM WASH PUMP.

a. Type the number 3 in the Cycles field.
b. Select ENTER.
c. Select F1: HM WASH PUMP.
Replacing the HM Wash Wheel

3. Remove the HM cover.
4. Using a screwdriver, remove the plastic guard from the wash station by
loosening the two screws on the facing side until the guard can slide out
from under the screws.
5. Remove and discard all reaction vessels from the wash and incubate
wheels.
5 - 72
WARNING: All reaction vessels removed from the wash wheel and
incubate wheel are biohazards. Follow laboratory safe
biohazard disposal procedures to discard reaction vessels.
6. Unscrew the wash wheel locking knob.

7. Use the knob to lift the wash wheel out of the instrument.
8. Install the new wash wheel.
a. Place any of the wash wheel’s three alignment holes onto the wash
wheel alignment pin.
b. Tighten the wash wheel locking knob.
c. Reinstall the HM cover.
d. Reinstall the guard onto the wash station.
9. Select PAUSE.
10. Select F7: DIAGNOSTICS> F3: ALIGNMENTS > F6: HM MODULE.
11. Perform the three incubate and wash wheel alignments located in the
top half of the HM Module Alignments screen.
the system Log Screen” in Chapter 2.
Replacing IMT QuikLYTE Multisensor Tubing

Note: Complete this procedure using a 3/32 allen wrench.
3. Select: F4: SYSTEM PREP > F3: IMT > F3: ALIGN/PRIME.
4. Lift the QuikLYTE multisensor cover and pull the multisensor interface
forward.
5 - 73
Figure 5-73: QuikLYTE Multisensor
5. Refer to the label on the instrument lid to identify where tubing is located
within the IMT system.
Note: The tubing to be replaced is labeled: R1, D1, D2, F1, F2, X2,
X3, W2, and Waste.
WARNING: The X2, X3, W2, and Waste tubing are biohazards. Follow
laboratory safe biohazard waste disposal procedures to
discard this tubing.
6. After replacing all the tubing, return the QuikLYTE multisensor interface
to its locked, upright position.
7. Select PAUSE.
8. Prime the IMT system with Salt Bridge solution.
9. Run a condition/soak cycle.
5 - 74
IMT Tubing
Note: Remove and replace tubing one at a time. When routing
tubing, place in plastic tubing guides wherever possible.
Table 5-10: IMT Tubing
Tubing Replacement
R1 1. Disconnect and replace this tubing and bottle cap combination.

2. Ensure the new tubing is placed completely into the pinch valve on the back
of the multisensor interface.
Figure 5-74: R1 Tubing
• 1: R1 attaches here
• 2: X1 attaches here
D1 and D2 Disconnect and replace this tubing.
F1 and F2 Disconnect and replace this tubing.
5 - 75
Tubing Replacement
W 1. Using the 3/32 Allen wrench, remove the two screws that hold the IMT port
to the baseplate.
Figure 5-75: Baseplate
2. Lift the IMT port up until its solenoid valve is accessible.

3. Disconnect and replace W2.
Note: W2 connects position 2 on the valve to the bottom of the IMT
port.
4. Reinstall the IMT port onto the baseplate using the two holes as noted in
the figure below.
Figure 5-76: Baseplate with IMT port removed
5. Perform Sample Probe to the IMT Port Alignment. See “IMT Port Alignment”
on page 35 of Alignments.
WARNING: The W2 tubing is a biohazard. Follow laboratory safe

biohazard waste disposal procedures to discard this
tubing.
5 - 76
Tubing Replacement
X2 1. Disconnect and replace this tubing.

Note: X2 connects the QuikLYTE integrated multisensor with the IMT
Pump.
2. Route this tubing through the holes in the sides of the sensor cartridge
interface. This will prevent pinching these lines when the interface is
closed.
WARNING: The X2 tubing is a biohazard. Follow laboratory safe

tubing.
X3 Disconnect and replace this tubing. X3 Connects the IMT Pump to the filter
T-fitting.
WARNING: The X3 tubing is a biohazard. Follow laboratory safe

tubing.
Waste Disconnect and replace this tubing. The waste tubing connects to the waste
bottle inside the system cabinet.
WARNING: The waste tubing is a biohazard. Follow laboratory safe

tubing.
Replacing the IMT Rotary Valve Seal

Note: Complete this procedure using Krytox® Grease, 3/32 allen
wrench, paper towels, disposable gloves, gauze, and
needlenose pliers.
2. Open the IMT lid.
3. Disconnect the tubing from the Standard A and Standard B bags.
5. Prime both Standard A and Standard B two times to remove fluid from
the A and B tubing.
5 - 77
Figure 5-77: IMT Rotary Valve
6. Locate the IMT Rotary Valve (to the right of the IMT interface).
7. Using needlenose pliers, remove the four screws or posts at each corner
in the top of the IMT Rotary Valve.
Figure 5-78: IMT Rotary Valve
8. Lift the rotary valve motor off the valve body. Turn it over and remove
the rotary valve seal from the valve seal holder on the encoder assembly.
9. Press down firmly on the encoder assembly and ensure that it springs
back with a click sound.
Note: If it does not, contact the Customer Care Center - Technical
Solution: Inside U.S.: 1-800-441-9250; Outside U.S. Refer to
the local support team.
5 - 78
Figure 5-79: Valve Seal
# Description
1 Motor
2 Encoder Assembly
3 Valve Seal
4 Inside Valve Body
5 Valve Body
10. Clean the inside of the valve body with a gauze pad lightly moistened
with water.
11. Place a pinhead-sized drop of Krytox grease on a gloved forefinger.
Gently rub the gloved forefinger and thumb together, then rub both
sides of the new rotary valve seal between the thumb and forefinger.
12. Install the new rotary valve seal with the flat side against the valve seal
holder on the valve motor assembly.
Note: The X and the slot on the seal should be facing towards the
operator.
13. Reinstall the motor assembly into the valve body by tightening the four
screws using the needlenose pliers.
14. Reconnect the tubing to the Standard A and Standard B bags.
15. Prime Standard A, Standard B, and the Flush solution.
5 - 79
Replacing the IMT Rotary Valve Tubing

CAUTION: Tubing for the Dimension EXL system is labeled in triplicate.

3. Open the QuikLYTE Multisensor interface lid.
Figure 5-80: QuikLYTE Multisensor
Note: The QuikLYTE Multisensor interface is located inside the IMT

interface.
4. Remove the plastic tubing connectors from the Standard A and Standard
B bags to disconnect the tubing.
6. Prime Standard A and Standard B each two times to remove fluid from
the tubing.
7. Disconnect the A and B tubing at the fittings on the IMT rotary valve.
5 - 80
Figure 5-81: IMT Rotary Valve Tube Fittings
# Description
1 From IMT Sample Port
2 From Standard A Bag
3 From Standard B Bag
4 To QuikLYTE Integrated Multisensor
8. Disconnect the X1 tubing from the QuikLYTE integrated multisensor and

the X0 tubing from the IMT sample port and at the fittings on the IMT
rotary valve.
WARNING: The X0 and X1 tubing are biohazards. Follow laboratory safe

biohazard waste disposal procedures when discarding them.
9. Connect new tubing A, B, X0, and X1.

10. Select PAUSE.
11. Run a condition/soak cycle (see “Cleaning the IMT System” on page 11 of
this chapter).
5 - 81
Replacing the LOCI Insert

Note: Complete this procedure using a pipette tip.
2. Open the LOCI access door.
3. Lift up the LOCI arm and rotate it out of the way.
4. Remove the rubber seal.
5. Carefully insert a pipette tip or slender object into the read chamber.
6. Press the tip against the inside of the insert and draw the insert out.
7. Hold the new insert by the top edge and carefully drop it into the LOCI
chamber.
8. Carefully re-insert the rubber seal and press firmly down around the
entire surface to ensure it is inserted fully.
9. Close LOCI access door.
Figure 5-82: LOCI Insert
11. Select F7: DIAGNOSTICS > F1: ELECTRO/MECH > F2: SAMPLE SYSTEM >
F7: LOCI MODULE > F7: STATISTICS.
12. Select F1: RESET to reset the LOCI statistics. The following message
displays Do you really want to clear the LOCI statistics file? y/n. Press Y
to confirm.
13. In the field next to CYCLE, enter 40 as the number of cycles to perform.
14. Select F8: CYCLE.
15. Exit to the main operating screen.
5 - 82
Replacing the LOCI Vacuum Cup

1. Select F7: DIAGNOSTICS > F1: ELECTRO/MECH > F2: SAMPLE SYSTEM >
F7: LOCI MODULE.
2. Select F6: INSPECT to rotate the LOCI arm out above the HM wheel.
3. With one hand grasp the arm and with the other, grasp the rubber
vacuum cup.
4. Pull down on the vacuum cup to remove it.
5. Press new vacuum cup on arm in reverse motion making sure it is
pressed firmly to the underside of the arm.
6. Exit to the main operating screen.
7. Realign the LOCI arm. See “LOCI Arm Alignment ” on page 15 of
Alignments.
Figure 5-83: LOCI Vacuum Cup
Note: During this procedure, a LOCI arm mis-positioned error may

appear. Disregard and select Reset when procedure is
complete.
5 - 83
Replacing the Photometer Filter Wheel Dual Sensor

3. Turn the bottom splined shaft on the R2 reagent arm to raise the reagent
probe out of the drain.
Figure 5-84: Probe and Splined Shaft
4. Using the screwdriver, loosen the three captive screws that secure the R2
reagent arm to the instrument.
Note: Move the R2 arm counterclockwise to access and loosen
captive screw number 3.
5. Carefully lift the R2 reagent arm and set it aside.
5 - 84
Figure 5-85: R2 Reagent Arm Alignment Pin and Captive Screws
6. Unplug P/J 34C.

7. Remove the screw in the center of the S1 sensor and remove the sensor
from the instrument.
CAUTION: Be careful not to touch, scratch, or damage any of the optical

filters during this procedure.
Figure 5-86: Optical Filters
8. Install the new dual sensor by reversing the previous steps.

9. Reinstall the R2 reagent arm.
5 - 85
10. Position the alignment slot in the R2 reagent arm over the alignment pin
in the instrument baseplate. Tighten the captive screws.
12. Perform the R2 Reagent Probe Alignment procedure. See “R2 Reagent
Probe Alignments” on page 22 of Alignments.
13. Perform a System Check and Daily QC.
Replacing the Photometer Home Sensor

Note: Complete this procedure using a 5/64 allen wrench and a
screwdriver.
probe out of the reagent drain.
4. Using a screwdriver, remove the three captive screws that secure the R1
arm to the instrument.
5. Use the 5/64 Allen wrench to remove the screw that secures the sensor
to the baseplate.
5 - 86
6. Pull sensor connector P/J 13D up through the hole in the baseplate and
disconnect it.
Figure 5-87: Photometer Home Sensor
# Description
1 R1 Reagent Arm
2 Photometer Home Sensor
7. Install the new photometer home sensor and the R1 reagent arm by
reversing the previous steps.
9. Perform Step 1 through Step 4 of the Photometer Alignment procedure.
See “Photometer Alignment ” on page 17 of Alignments.
5 - 87
Replacing Printer Paper

1. Push the Cover Open lever on the top right side of the printer.
2. Lift the cover.
3. Remove any remaining paper.
4. Position the new paper roll so the paper comes out from the bottom.
5. Pull the leading edge of the paper over the front of the printer.
6. Push down both sides of the printer cover until you hear a click.
Replacing a Pump Optical Sensor

Note: Complete this procedure using a screwdriver, 3/32 allen
wrench, 11/32 allen wrench, needlenose pliers and a 5/64
hex wrench.
1. With the system in standby, select F4: SYSTEM PREP > F7: PUMP PRIME.
2. Open the instrument doors.
3. Locate the pump assembly.
4. Press the pump assembly release button and pull the pump assembly
outward.
5 - 88
Figure 5-88: Pump Panel
# Description
1 Pump Panel Release Button
2 Hold With Needlenose Pliers
3 Thumbscrew
4 Sampler (100 µL and 2500 µL)
5 Diluent (500 µL)
6 HM (2500 µL)
7 R2 Reagent (500 µL and 2500 µL)
5. Remove the plastic shield on the rear of the pump assembly by loosening
the captive screw at the top of the shield.
6. Locate the sensor to be replaced and disconnect its connector.
7. Use the 5/64 hex wrench to remove the hex screw holding the sensor to
its bracket.
8. Remove and discard the sensor.
5 - 89
9. Install the optical sensor on the bracket using the 2-56 x.25 hex screw.
CAUTION: Overtightening the screw could damage the sensor.

10. Plug the optical sensor into the connector.
11. Check the syringe gap between the bottom of the syringe and the top of
the metal plunger using a folded piece of printer paper.
Note: Printer paper should be equal to four thickness to set a gap of
0.005-0.010 inches (0.13-0.25 mm).
a. If the setting is correct, skip to Step 17.
b. If the setting needs adjustment, continue with Step 12.
Figure 5-89: Gap Setting Chart
12. Using the 11/32 wrench, loosen the locking nut.

Figure 5-90: Optical Sensor
# Description
1 Optical Sensor
2 Locking Nut
3 Adjustment Screw
5 - 90
13. Turn the adjusting screw to lower the adjusting screw away from the
optical sensor.
Note: The syringe indicator light (LED) on the front panel of the
appropriate Motor Control Board in the card cage should now
be off.
14. Turn the lead screw on the pump panel to the raise the syringe plunger
and check the syringe gap between the bottom of the syringe and the
top of the metal plunger using a folded piece of paper.
Note: Printer paper should be equal to four thickness to set a gap of
0.005-0.010 inches (0.13-0.25 mm).
15. With the gap held steady, turn the adjustment screw until the syringe
indicator light (LED) on the front panel of the appropriate Motor Control
Board in the card cage just lights.
Table 5-11: Syringe Motor Control Board Slot Chart
Syringe Motor Control Board Slot LED
Sample 2500 µL Slot 3 CR2A
Sample 100 µL Slot 3 CR2C
R2 2500 µL Slot 3 CR3A
R2 500 µL Slot 3 CR3C
Diluent Slot 4 CR6C
HM Wash Slot 5 CR5C
16. Recheck the gap using Step 11.
5 - 91
Figure 5-91: Lead Screws
17. Prime the appropriate pump.

a. Select F4: SYSTEM PREP > F7: PUMP PRIME.
b. Move the cursor to the Cycles field and type the number of cycles to
be performed.
c. Press the appropriate function key to begin priming the pump.
18. If the gap setting is correct, tighten the locknut and prime 6 more times.
19. After priming the pump, recheck the gap setting.
a. If the gap setting is correct, skip to Step 20.
b. If further adjustment is required, use the 3/32 allen wrench to turn
the adjustment screw as needed and repeat Step 11.
c. Select RESET and check the gap.
20. Using the 3/32 allen wrench to keep the adjustment screw from turning,
tighten the locking nut using the 11/32 wrench.
21. After tightening this nut, perform another pump prime.
22. Check the gap to ensure that it did not move while the locking nut was
tightened.
23. Replace the plastic shield on the rear of the pump assembly.
24. Close the assembly.
25. Prime the pump.
5 - 92
Replacing a Pump Solenoid Valve

Do not use the valves in the Accessory Kit to replace IMT Diluent Solenoid 1 or
IMT Diluent Solenoid 2. If both solenoid valves need to be replaced, contact
the Customer Care Center - Technical Solution: Inside U.S.: 1-800-441-9250;
Outside U.S. Refer to the local support team.
2. Open the front instrument doors.
outward.
4. Locate the solenoid valve to be replaced and disconnect its connector.
5. Follow the yellow wires from the solenoid valve to locate the solenoid
connectors in the rear of the pump panel.
5 - 93
Figure 5-92: Pump Panel Solenoid Valve
# Description
1 Sampler Solenoid 1
2 Reagent 2 Solenoid
3 Sampler Solenoid 2
4 HM Solenoid 1
5 Reagent 1 Solenoid
6 IMT Diluent Solenoid 1
7 HM Solenoid 2
8 IMT Diluent Solenoid 2
6. Remove the tubing from the old solenoid valve.

7. Using the 3/32 Allen wrench, loosen two screws on the top of the old
solenoid valve to remove it from its support bracket.
a. Replace it with the new valve.
b. Attach the tubing to the new valve.
5 - 94
CAUTION: If Sampler solenoid valve 2, or HM solenoid valves 1 and 2 or

need to be replaced, refer to the illustration below to ensure that
the circular label on the valve faces outward. If replacing Sampler
solenoid valve 1, or Reagent solenoid valves 1 and 2, ensure that
the circular label faces inward.
Figure 5-93: Pump Solenoid Valve
8. Display the Pump Prime Menu screen and prime the appropriate pump.
b. Move the cursor to the Cycles field and type 6 for the number of
cycles to be performed.
c. Press the appropriate function key to begin priming the pump for
the solenoid valve that was replaced.
d. While priming, check for any tubing leaks.
e. Continue priming the pump until all the air is out of its tubing.
9. Perform a System Check and the Daily QC.
5 - 95
Replacing a Pump Syringe

Note: Complete this procedure using a 7/64 allen wrench, 3/32
allen wrench, 3/16 allen wrench, 11/32 wrench, needlenose
pliers and a screwdriver.
2. Open both front instrument doors and locate the syringe to be replaced.
Figure 5-94: Pump Panel
# Description
1 Pump Panel Release Button
2 Hold With Needlenose Pliers
3 Thumbscrew
4 Sampler (100 µL and 2500 µL)
5 Diluent (500 µL)
6 HM (2500 µL)
5 - 96
3. Remove the thumbscrew from the bottom bracket of the syringe.
CAUTION: Use the needlenose pliers on the metal part of the syringe
plunger. Do not use pliers on the glass part of the syringe.
outward.
5. Remove the plastic shield on the rear of the pump assembly by loosening
the captive screw at the top of the shield.
6. Manually turn the syringe’s pump lead screw to completely lower the
syringe plunger.
Figure 5-95: Pump Lead Screws
7. Remove the tubing on both sides of the syringe.

Note: Use the needlenose pliers to loosen the knurled fitting before
removing by hand, if needed.
8. Using the 7/64 Allen wrench, remove the screw from the top bracket of
the syringe.
WARNING: The pump syringe is a biohazard. Follow laboratory safe

biohazard procedures when performing maintenance and
troubleshooting.
9. Fit the new syringe into the upper bracket and loosely tighten the 7/64
Allen screw in the upper bracket.
10. Attach the tubing to the fitting, turning the syringe slightly to obtain
better access.
5 - 97
11. Slowly pull the plunger down until it is snug in the bottom syringe
bracket, then attach and completely tighten the thumbscrew.
CAUTION: Use the needlenose pliers only on the metal part of the syringe
plunger. Do not use pliers on the glass part of the syringe.
12. Completely tighten the 7/64 Allen screw at the top of the syringe bracket.
13. Check the syringe gap between the bottom of the syringe and the top of
the metal plunger using folded piece of paper.
Note: The printer paper should be folded to equal four thickness to
set a gap of 0.005-0.010 inches (0.13-0.25 mm).
a. If the gap setting is correct, the printer paper should barely be able
to slide between the bottom of the syringe and the top of the metal
plunger. If adjustment is not required, proceed to step 19.
b. If a gap adjustment is required, continue with step 14.
Figure 5-96: Syringe
# Description
1 Plunger
2 Syringe
3 Foot of Plunger
4 Slide Paper into this Gap
5 - 98
Figure 5-97: Lead Screws
14. Using the 11/32 wrench, loosen the locking nut.
# Description
1 Optical Sensor
2 Locking Nut
3 Adjustment Screw
5 - 99
15. Turn the adjusting screw to lower the adjusting screw away from the
optical sensor.
Note: The syringe indicator light (LED) on the front of the panel of
the appropriate Motor Control Board in the card cage should
now be off.
16. Turn the lead screw on the pump panel to the right of the syringe
plunger and check the syringe gap between the bottom of the syringe
and the top of the metal plunger using a folded printer paper.
17. With the gap held steady, turn the adjustment screw until the syringe
indicator light (LED) on the front of the panel of the appropriate Motor
Control Board in the card cage just lights.
18. Recheck the gap using step 13.
Table 5-12: Syringe Motor Control Board Slot Chart
Syringe Motor Control Board Slot LED
Sample 2500 µL Slot 3 CR2A
Sample 100 µL Slot 3 CR2C
Diluent Slot 4 CR6C
HM Wash Slot 10 CR3A
19. Display the Pump Prime Menu screen and prime the appropriate pump.
c. Press the appropriate function key to begin priming the pump for
the solenoid valve that was replaced.
d. While priming, check for any tubing leaks.
e. Continue priming the pump until all the air is out of its tubing.
20. After priming the pump, check the gap setting again.
21. If the gap setting is correct, use the 3/32 allen wrench inserted at the
bottom of the adjusting screw to keep the screw from turning, tighten
the locking nut using the 11/32 allen wrench.
22. After tightening the nut, perform another pump prime. Make a final
check of the gap to ensure that it did not move while the locking nut was
tightened.
23. If further adjustment is required, repeat step 14.
24. Select RESET and recheck the gap.
5 - 100
25. Replace the shield on the rear of the pump assembly.

26. Close the assembly.
27. Perform a System Check and your Daily QC.
Replacing a Reagent Arm Radial Home Sensor

screwdriver.
The reagent arm radial home sensor is located midway along the reagent arm.
3. Turn the bottom splined shaft on the reagent arm to raise the reagent
WARNING: The R2 probe is a biohazard. Follow laboratory safe biohazard

procedures when performing maintenance and
troubleshooting.
4. Move the probe away from its reagent drain until the sensor is accessed.
5. Disconnect P/J 20C for R1 (or P/J 80D for R2).
6. Using a screwdriver, remove the screw that holds the radial home sensor
to the reagent arm.
7. Remove the sensor.
Figure 5-98: Radial Home Sensor
5 - 101
CAUTION: Be careful not to damage any other connectors when cutting tie
wraps.
Note: Position the R1 sensor with the yellow and black wires at the
top.
10. Perform all the reagent arm alignments for the probe on which the
sensor was replaced. See “R1 Reagent Probe Alignments” on page 18 of
Alignments. See “R2 Reagent Probe Alignments” on page 22 of
Alignments. See R3 Probe Alignments in the RMS Operator’s Guide.
Replacing a Reagent Arm Vertical Home Sensor

screwdriver.
The reagent arm vertical home sensor is located at the probe end of the
reagent arm.

troubleshooting procedures.
4. Move the probe away from its reagent drain (by turning the top shaft of
the R1 reagent arm).
5. Disconnect P/J 20D for R1 or P/J 80B for R2.
5 - 102
Figure 5-99: Vertical Home Sensor
# Description
1 Vertical Home Sensor
2 Cable Holder
CAUTION: Be careful not to damage any other connectors when cutting tie
wraps.
6. Using a screwdriver, remove the screw that holds the vertical sensor to
the sensor housing bracket and remove the sensor from the reagent arm.
9. Press PAUSE to restart the sampling system.
10. Perform all the reagent arm alignments for the probe on which the
sensor was replaced.
11. Close the system lids.
5 - 103
Replacing the R2 Reagent Arm Angular Home Sensor

screwdriver.

4. Move the probe away from its reagent drain until the sensor can be
accessed.
5. Disconnect P/J 32D.
6. Using a screwdriver, remove the screw that holds the sensor to its
bracket.
7. Remove the sensor from the instrument.
Figure 5-100: Rotational Home Sensor
8. Separate the metal clip from the old sensor and place it on the new
sensor.
5 - 104
Figure 5-101: Metal Clip
# Description
1 Metal Clip
2 Sensor
3 Bracket
4 Wires From Sensor Straddling Bracket Arm
9. Install the sensor by reversing the previous steps.

12. Perform all the R2 reagent arm alignments.
5 - 105
Replacing a Reagent Probe Tip

Note: Complete this procedure using 5/16 and 1/4 wrenches or
ratchet and offset wrenches.
Figure 5-102: Wrenches
# Description
1 Ratchet Wrench
2 Offset Wrench
3 Open-End Wrench

5 - 106

procedures for contact with and disposal of this probe.
4. If replacing the R2, move the probe away from its reagent drain until its
reagent probe tip can be accessed.
5. Place a paper towel under the probe to prevent anything from falling into
a reagent cartridge while moving the probe tip.
6. Remove the probe tip and nut by using the 5/16 wrench with either the
offset wrench or the ratchet wrench.
a. Using the 5/16 wrench and the offset wrench:
1) Place the 5/16 wrench on the reagent probe body to keep it
from turning.
2) Slide the 1/4 end of the offset wrench up the reagent probe
and onto the probe tip nut.
3) Turn the offset wrench clockwise to loosen the probe tip nut.
Once loose, unscrew it by hand to remove the probe tip and
nut.
5 - 107
Figure 5-104: Offset Wrench
# Description
1 Open-end Wrench
2 Offset Wrench (Turn clockwise to remove probe)
b. Using the 5/16 open-end wrench and the ratchet wrench:

from turning.
2) With the “ON” marking on the ratchet wrench facing upward,
slide the 1/4 opening of the ratchet wrench up the reagent
probe and onto the probe tip nut.
3) Once the probe tip nut is loose, unscrew it by hand to remove
the probe tip and nut.
5 - 108
Figure 5-105: Ratchet Wrench
# Description
1 Open-End Wrench
2 Ratchet Wrench (Turn Clockwise to

Loosen Probe)
7. Insert a new reagent probe tip into a new probe tip nut.
8. Screw the new reagent probe tip onto the reagent probe body
finger-tight.
Figure 5-106: Reagent Probe Tip
# Description
1 Reagent Probe
2 Nut
5 - 109
9. Completely tighten the new reagent probe tip using the 5/16 open-end
wrench with offset wrench or ratchet wrench.
a. Using the ratchet wrench to tighten the probe tip:
from turning.
2) With the “Off” marking on the ratchet wrench facing up, slide
the 1/4 opening of the ratchet wrench up the reagent probe
3) Turn the ratchet wrench counterclockwise to completely
tighten the probe tip and nut to the probe body.
10. Close the instrument lids and select PAUSE to restart the sampling
system.
11. Select F4: SYSTEM PREP > F7: PUMP PRIME.
12. Move the cursor box to the appropriate reagent probe tip field, and select
ENTER to change the field from NO to YES.
14. Prime the reagent pump by:
a. Selecting F4 SYSTEM PREP > F7: PUMP PRIME.
c. Select the appropriate function key to begin priming the reagent
pump for the tip that was replaced.
15. Perform the Reagent Probe Alignments procedures, see Chapter 6:
Alignments
16. Perform the Daily QC.
Replacing the Reagent Tray Home Sensor

Note: Complete this procedure using a 9/64 allen wrench, 5/32
allen wrench and a screwdriver.
3. Locate the reagent tray drive.
4. Disconnect the two reagent tray drive motor connectors, P/J 50G and
P/J 3C.
5. Remove all tubing clamps from the reagent tray drive bracket.
5 - 110
Figure 5-107: Reagent Tray Home Sensor
# Description
1 P/J50G and 3C wires
2 Bar
3 Tubing Clamps
6. Using the 9/64 Allen wrench, loosen the four screws that secure the drive
motor to its bracket.
7. Slide the drive motor toward the front of the instrument to disengage its
gears.
5 - 111
Figure 5-108: Drive Motor and Screws
# Description
1 Motor Screws
2 Allen Screws
8. Use a screwdriver to remove the three screws that secure the reagent
tray drive assembly to the instrument baseplate.
9. Remove the assembly by carefully lifting it up and out of the instrument.
10. Gently pull the spring bar outward until the reagent tray home sensor
can be pushed out of its hole in the spring bar.
11. Remove one cable clamp and disconnect P/J 50H.
5 - 112
Figure 5-109: Springbar
# Description
1 Springbar
2 Sensor
12. Install the new reagent tray home sensor.

13. Install the reagent tray drive assembly:
a. Slide the drive motor to the rear of its bracket, then place it in the
instrument and tighten the three screws that secure its bracket to
the instrument baseplate.
b. Slide the drive motor all the way toward the center of the
instrument to engage its gears and then, holding it in this position,
tighten the four screws that secure the drive motor to the bracket.
Note: If the gears do not engage, remove the reagent tray cover
and manually turn the reagent tray until the gears fit
properly.
15. Restore power to the instrument following “Restoring Power After a
16. Perform the reagent tray alignments, see “Reagent Tray Alignment” on
5 - 113
Replacing Reagent Tubing

Note: Complete the following procedure using a screwdriver.
2. Raise the IMT lid and reagent lids.
Note: Perform Step 3 only if replacing the R2 reagent tubing;
otherwise skip to Step 7.
3. Turn the bottom splined shaft on reagent arm R2 to raise its reagent
4. Move reagent arm R2 counterclockwise toward the front of the
instrument until its tubing can be accessed.
5 - 114
Figure 5-111: Rotate R2 Arm
5. Unscrew the knurled fitting from the tubing.

Figure 5-112: Knurled Fitting
# Description
1 Knurled Fitting
2 500 µL Syringe
6. Save this knurled fitting because it will be installed later in this

procedure.
7. Open the front cabinet doors and remove the reagent tubing from the
left port of the reagent arm 500 µL syringe by pulling on the knurled
fitting
5 - 115
8. Disconnect the reagent tubing from the reagent probe by pulling on the
probe knurled fitting.
9. Unscrew the knurled fitting from the tubing and pull the tubing through
the spring guide.
Figure 5-113: Spring Guide
# Description
1 Spring Guide
2 Knurled Fitting
10. Remove the tubing from tubing clamps or guides as necessary and pull it
up through the instrument.
11. Discard the tubing.
12. Start from the reagent probe and thread the new tubing down through
the instrument to the reagent pump.
13. Position the black wrappings (or stamped markings) on the reagent
tubing as shown in Figure 5-114.
5 - 116
Figure 5-114: Reagent Probe Tube Routing
# Description
1 R2 Tubing
2 Tubing Clamps
3 R1 Tubing
4 Tubing Guide
5 Spring Clamp
5 - 117
Figure 5-115: R1 Tubing
# Description
1 R1 Tubing
2 R2 Tubing
14. Attach the knurled fitting removed from the old tubing in step 5 of this
procedure to the pump end of the new tubing by screwing the fitting on
by hand until approximately 1/16 inch (1.5 mm) of the tubing extends
past the fitting.
15. Press the tubing onto the 500 µL reagent syringe fitting.
Figure 5-116: 1/16” of Tubing
16. Install the new reagent tubing through the spring guide and onto the
reagent probe.
5 - 118
17. To install the reagent tubing through the spring guide:

a. Pull the tubing through the spring guide to position the black
wrapping (or stamped marking).
Figure 5-117: Stamped Marking
# Description
1 Spring Guide
2 Metal Fitting
3 Knurled Fitting
4 2.25 inches (5.7 cm)
b. Attach the knurled fitting removed in Step 8 to the reagent probe

end of the tubing as described in Step 12. Press tubing completely
onto the metal fitting on the reagent probe.
18. Close the instrument doors and lids.
20. Display the Pump Prime menu screen from the operating menu by
Selecting F4: SYSTEM PREP > F7: PUMP PRIME.
21. Move the cursor to the Cycles field and type 3 for the number of prime
22. Select ENTER.
23. Select the function key for the reagent pump that had its tubing
replaced.
24. Check the reagent tubing for leaks while the system is priming.
5 - 119
Replacing the Sample Probe Tip

Note: Complete this procedure using 5/16 and 1/4 wrenches or
ratchet and offset wrenches.
Figure 5-118: Wrenches
# Description
1 Ratchet Wrench
2 Offset Wrench
3 Open-End Wrench

3. Lift and move the sample probe out of and away from the sample drain.
5 - 120
WARNING: The sample probe is a biohazard. Follow laboratory safe

protection biohazard procedures when performing
maintenance and troubleshooting procedures.
Figure 5-119: Sample Probe
4. Remove the probe tip and nut using the 5/16 open-end wrench with
either the offset wrench or the ratchet wrench:
a. Using the 5/16 open-end wrench and the offset wrench:
1) Place the 5/16 wrench on the sample probe body to stabilize it
and prevent it from turning.
2) Slide the 1/4 end of the offset wrench up the sample probe
3) Turn the offset wrench clockwise to loosen the probe tip nut.
Once loose, unscrew it by hand to remove the probe tip and
nut.
5 - 121
Figure 5-120: Sample Probe and Offset Wrench
# Description
1 Open Ended Wrench
2 Offset Wrench
b. Using the 5/16 open-end wrench and the ratchet wrench:

1) Place the 5/16 wrench on the sample probe body to stabilize it
and keep it from turning.
2) With the “ON” marking of the ratchet wrench facing upward,
slide the 1/4 opening of the ratchet wrench up the sample
3) Turn the ratchet wrench clockwise to loosen the probe tip
nut. Once loose, unscrew it by hand to remove the probe tip
and nut.
5 - 122
Figure 5-121: Sample Probe Ratchet Wrench
# Description
1 Ratchet Wrench
2 Open Ended Wrench
5. Insert a new sample probe tip into a new probe tip nut and screw it onto
the sample probe body finger-tight.
6. Completely tighten the new sample probe tip using the 5/16 open-end
wrench with offset wrench or ratchet wrench.
a. To use a ratchet wrench to tighten the probe tip:
1) Place the 5/16 wrench on the sample probe body to keep it
from turning.
2) With the “OFF” marking on the ratchet wrench facing upward,
slide the 1/4 opening of the ratchet wrench up the reagent
3) Turn the ratchet wrench counterclockwise to completely
tighten the probe tip and nut to the probe body.
7. Close the instrument lids and select PAUSE to restart the sampling
system.
8. Select F4: SYSTEM PREP > F6: SYS COUNTERS.
9. Move the cursor box to the Sample Probe Tip field.
10. Select ENTER to change the field from NO to YES.
5 - 123
12. Prime the sample pump by:

a. Selecting F4: SYSTEM PREP > F7: PUMP PRIME.
c. Select F2: SAMPLER to begin priming the sample pump.
13. Perform the Sample Probe Alignments procedure, see “Sample Probe
Alignments” on page 29 of Chapter 6: Alignments.
14. Perform Daily QC.
Replacing Sample Tubing

WARNING: All used sample tubing may present a biohazard or chemical
hazard. Follow safe laboratory biohazard procedures for
protection from biohazards and chemicals when performing
maintenance and troubleshooting procedures.
1. With the instrument in standby, press PAUSE to stop the sampling

system.
3. Open both system doors to remove the existing clot check tubing.
Remove the sample tubing from the left port of the 100 µL syringe.
Figure 5-122: Syringe Left Port
# Description
1 Left Port
2 To Sample Probe
3 100 µL Syringe
4. Remove the plastic sleeve from the end of the tubing. Set this fitting
aside for use later in the procedure.
5 - 124
5. Open the pump panel to access the tubing on the end of the clot check
board.
6. Slide the plastic sleeve back and remove the tubing from both sides of
the clot check fittings. Remove the plastic sleeves from both pieces of
tubing before removing the tubings from the conduit.
Figure 5-123: Clot Check Tubing
7. Remove the sample tubing from the 100 µL syringe and pull through the
conduit.
8. At the sample probe, gently pull out on the sides of the sample cover and
lift it off the probe assembly.
Figure 5-124: Sample Probe Cover Assembly
9. Remove the sample tubing from the sample probe connection and pull
the tubing up through the system.
10. Press the black sheathed end of the new sample tubing onto the sample
probe connection. Remove the plastic sleeves from the end of the sample
tubing.
5 - 125
11. Rout the other end of the sample tubing down through the corrugated
black plastic conduit until it comes out of the opening on the left side of
the clot check board.
12. Slide the plastic sleeve onto the end of the tubing and slide the tubing
onto the clot check board fitting.
13. Attach the sample tubing and press the tubing onto the left port of the
100 µL syringe.
14. Remove the plastic sleeve from the end of the tubing and feed it through
the corrugated black plastic conduit until it comes out of the opening on
the right side of the clot check board.
15. Slide the plastic sleeve on the end of the tubing.
16. Flare the sample tubing if needed. Flare the tubing by inserting the flare
tool from the Spare Parts kit into the end of the tubing that will be
slipped onto the fitting. Slide the tubing onto the clot check board fitting.
17. Close the system lids and press PAUSE to turn on the sampling system.
18. Display the Pump Prime menu.
a. Move the cursor to the Cycles field.
b. Type 3 for the number of prime cycles to be performed.
c. Press ENTER.
d. Select F2: SAMPLER.
19. Check the sample tubing for leaks while the system is priming.
20. Perform a system check and daily QC.
5 - 126
Replacing the Source Lamp

WARNING: Wait at least five minutes after turning off the instrument
power for the source lamp assembly to cool before continuing
this procedure.
2. Lower the cuvette thermal chamber, see “Lowering and Raising the
Thermal Chamber” on page 21 of this chapter.
3. Loosen the two captive thumbscrews that hold the source lamp assembly
in place.
Figure 5-125: Source Lamp Assembly
# Description
1 P/J 72B
2 Screws
3 Source Lamp Assembly
WARNING: Source lamp assembly may be hot.
4. Unplug the source lamp connector P/J 72 B located inside the cuvette
thermal chamber. Remove the source lamp assembly.
5. Install the new source lamp assembly by reversing Step 2 through Step 4.
5 - 127
CAUTION: Do not raise the thermal chamber by lifting up on the plastic

components where the air hose connects to the thermal
chamber.
6. Raise the thermal chamber.
7. Restore power to the instrument following “Restoring Power After a
CAUTION: If the photometer fails to initialize, perform the Photometer Lamp

Calibration procedure, see “Photometer Lamp Calibration” on
page 128 of this chapter before continuing with Step 8.
8. Verify that there is no slack in the film coming out of the cuvette film
cartridge. If there is:
a. Select F4: SYSTEM PREP > F6: SYS COUNTERS> F3: FILM LOAD.
b. Select F2: TENSION.
9. Perform the Photometer Alignment, see “Photometer Alignment ” on
11. Recalibrate the following methods: C3, C4, CCRP, CRBM, CRP, GENT,
HA1C, HB1C, IGA, IGG, IGM, LIDO, MALB, MPAT, NAPA, PALB, PHNO,
PROC, PTN, RCRP, THEO, TOBR, TRNF, VALP, VANC. Their performance can
be affected by a new source lamp.
Photometer Lamp Calibration

1. Ensure that all instrument doors and lids are closed.
2. Select F7: DIAGNOSTICS > F3: ALIGNMENTS > F4: PHOTOMETER.
3. Select F1: DARK CALIB.
Note: If the system has been on for more than 30 minutes and the
cuvette temperature icon is not appearing at the top of the
screen, answer the message with a Y. The dark calibration
takes approximately 30 seconds.
4. When the dark calibration is complete select F2: LAMP CALIB.
Note: When the time on the High field on the screen is ≥ 30
minutes, answer the message with a Y. The lamp calibration
takes approximately 30 seconds.
5. Press EXIT.
6. Continue with Step 8 of section titled “Replacing the Source Lamp” .
5 - 128
Replacing the U-Seal Element

Note: Complete this procedure using a screwdriver, needlenose
pliers, and a tie-wrap.
2. Select F7: DIAGNOSTICS > F1: ELETRO/MECH > F4: CUVETTE.
3. Select F4: U-SEAL SOLENOID twice.
4. Raise the barcode reader.
5. Unscrew the alignment bar thumbscrew and raise the alignment bar out
of the way.

extremely hot. Wait five minutes for the components in this
area to cool before continuing with this procedure.
# Description
1 Barcode reader
2 Alignment bar thumbscrew
the right.
7. Move this assembly to the left away from the cuvette ring.
5 - 129
# Description
3 U-Seal Solenoid
8. Unplug the U-Seal element connector: P/J 13L.
5 - 130
Figure 5-128: U-Seal Element Connector
# Description
1 Tie Wrap
2 Tie Mount
3 P/J 13 L
9. The cable is looped around the tie wrap. With needlenose pliers, break
the tie wrap and remove it.
10. Using the screwdriver gently pry the U-Seal element off its metal frame.
5 - 131
# Description
1 U-Seal Element
2 Pry Here
11. Snap the new U-seal element onto the metal frame.
12. Curl the end of a new tie wrap to permit easy access.
13. Insert the tie wrap through the tie mount on the cuvette arm.
14. Insert the end of the tie wrap through the head of the tie wrap and form
a loop about 3/4” in diameter.
5 - 132
# Description
1 Tie Wrap
2 Tie Mount
3 P/J 13 L
15. Pass the P/J 13L cable through the tie wrap loop and wrap it around once.
Connect P/J13L.
16. Tighten the tie wrap around the cable enough to hold but not pinch it.
17. Cut off the excess tie wrap.
18. Reposition the U-seal solenoid near the cuvette ring and push the curved
locking bar into place.
19. Position the alignment bar and tighten its thumbscrew.
5 - 133
Replacing the Vacuum Pump Muffler Filter

1. With the system in standby, open the instrument doors.
2. Open the pump panel assembly by pressing its release button.
3. Remove the chemistry wash and water bottle from the instrument to
access the vacuum pump muffler.
4. Unscrew the black plastic cover from the vacuum pump muffler by
turning it toward the rear of the instrument.
Figure 5-131: Vacuum Pump Muffler
Figure 5-132: Vacuum Pump Filter
# Description
1 Cover
2 Filter
5. Remove the old felt filter off of the vacuum pump fitting and replace it.
5 - 134

Replacing the Water Bottle

1. With the system in standby, open the instrument doors.
2. Open the pump panel assembly by pressing its release button.
3. Remove the water bottle from the system.
4. Disconnect connector P/J 1A. Follow the cable that comes out of the hole
labeled LEVEL to locate P/J 1A.
Figure 5-133: Water Bottle
5. Loosen the collar ring on the cap of the water bottle (the collar ring turns
without moving the cap).
6. Remove the dip tube assembly and place it in the spare water bottle.
7. Reconnect P/J 1A.
8. Place the water bottle back in the system.
Note: The water bottle should begin filling with water.
9. Wait until the water bottle is filled, and prime all system pumps:
c. Select ENTER.
d. Select F1: ALL.
10. Document this replacement on the Instrument Log screen. Refer to the
section titled “Using the Instrument Log Screen” in Chapter 2.
11. Clean the used water bottle. See “Cleaning the Water Bottle” on page 37
of this chapter.
5 - 135
Re-seating a Control Board in the Card Cage

2. Open the left cabinet door and attach the grounding wrist strap.
WARNING: Using the grounding wrist strap eliminates the possibility of

electrostatic discharge to the board.
3. Using a screwdriver, loosen the two captive screws.
Figure 5-134: Card Cage
# Description
1 Captive Screws
2 Square Handles
4. Use the square handles on the board faceplate to pull the board halfway
out of its slot and then firmly re-seat it.
5. Tighten the two captive screws.
5 - 136
Running a System Check Using ABS

Note: Complete this procedure using the ABS reagent cartridge in
the system, fresh ABS solution from the same lot of ABS
reagent cartridge on the instrument, a sample cup, transfer
pipette and a segment.
F4: SYSTEM CHECK.
2. Fill a sample cup with fresh ABS solution.
3. From the System Check Load List screen, enter a segment position for
this sample cup and then place the cup in that position.
4. Enter operator initials.
6. Acceptable ranges for the system check results are listed below. If the
System Check printout indicates that any of your results are not
acceptable, see “System Check Troubleshooting” on page 8 of Chapter 7:
Troubleshooting.
Note: To delete this System Check, press ALT+S to go to the
Segment Status screen. select F1: ON BOARD >
F4: DELETE SAMPLE and follow the message prompts as they
appear.
Note: If all System Check Means are failing, and ABS lots were
recently changed, enter the carton value from the ABS carton
end flap every time a new ABS lot is used.
Table 5-13: System Check Specifications For ABS

Mean SD





ABS carton ±12mAU
5 - 137
Note: If a mean or standard deviation is not reported, the system

check tests were aborted for the reagent or sampler systems.
Display the Error Log screen by navigating to:
F5: PROCESS CONTROL > F6: ERROR LOG, and resolve any
error messages and rerun the system check. See “System
Check Troubleshooting” on page 8 of Troubleshooting.
Running a System Check Using CHK

Note: Complete this procedure using the CHK reagent cartridge on
the instrument.
To schedule a time to run automated System Check, see “Configuring
Automated System Check Using CHK” on page 7 of Chapter 8: Configuration.
1. With the system in standby, display the System Check Load List screen by
selecting F4: SYSTEM PREP > F4: SYSTEM CHECK.
2. Ensure all instrument lids are closed.
4. Acceptable ranges for the system check results are listed below. If the
System Check printout indicates that any of the results are not
acceptable, refer to the section titled “System Check Troubleshooting” on
page 8 of Troubleshooting.
Note: Select F4: SYSTEM CHECK > F2: REVIEW DATA >
F4: ABORT CHECK to delete this system check.
Note: If all System Check Means are failing, and CHK lots were
recently changed, enter the carton value from the CHK carton
end flap every time a new CHK lot is used.
5 - 138
Table 5-14: System Check Specifications For CHK

Mean SD





CHK carton ± 15 mAU
Note: If a mean or standard deviation is not reported, see “System

Check Troubleshooting” on page 8 of Chapter 7: Troubleshooting.
Decontamination Procedure
Note: Perform this procedure only if advised to do so by a Siemens
representative. It takes approximately 50 minutes to
complete these steps.
1. Disable the water system supply:
a. From the Operating Menu, select F6: SYSTEM CONFIG.
b. Move the cursor to “Water In”.
c. Enter a password.
d. Select ENTER to change the selection from PLUMBED to MANUAL.
5 - 139
2. Prepare decontamination solution:

a. Use this table to determine the amount of bleach to add:
If % of Sodium Hypochlorite Then add this amount of bleach to

(bleach) in the product IS: water bottle:
5.25 500 mL
6.00 438 mL
8.00 328 mL
10.00 263 mL
12.00 219 mL
15.00 175 mL
Note: The bleach product must contain a minimum of 5.25%

sodium hypochlorite. It must contain no additives,
detergents, surfactants or fragrances and be 99.9% free of
impurities.
b. Fill a Dimension EXL system water bottle with deionized water and
add the required volume of bleach.
c. Cover and agitate the bottle to mix the solution.
d. Fill an empty Chemistry Wash bottle with the bleach solution and
pour half of the remaining solution into another water bottle.
3. Decontaminate the water and chemistry wash system:
a. Install a water bottle containing the bleach solution, then agitate
gently to wash the inside of the bottle, the bottom of the lid, and
the water bottle float switch assembly.
b. Install the Chemistry Wash bottle containing the bleach solution.
Gently agitate the bottle to clean the bottom of the lid and the
bottle float switch assembly.
c. Select F4: SYSTEM PREP > F7: PUMP PRIME.
d. Set CYCLES: to 10.
e. Select F1: PRIME WATER to pump bleach solution through the
system.
f. Select F6: HM
g. Set CYCLES: to 10.
h. Select F1: HM WASH PUMP to pump bleach solution through the
chemistry wash system.
i. Repeat this step 3 times.
4. Allow the bleach solution to remain in the lines for at least 30 minutes.
5 - 140
5. Rinse the water and chemistry wash systems:

a. Remove the water and Chemistry Wash bottle lids and float switch
assemblies and set them into spare bottles.
b. Discard each bottle's contents. Rinse each bottle 3 times with
deionized water.
c. Fill the bottles with deionized water and install the lid assemblies.
d. Agitate each bottle gently to rinse the bottom of the lids and the
float switch assemblies.
e. Cycle water through the system as described in step 3e through 3h.
f. Remove the bottles again as described in steps 5a and 5b. Discard
the contents.
g. Rinse the water bottle one more time with deionized water.
6. Reassemble the water and chemistry wash systems:
a. Install the water bottle and lid assembly on the system.
b. Change the Water In field from MANUAL to PLUMBED.
1) Select F6: SYSTEM CONFIG.
2) Move the cursor down to “Water In”.
3) Enter a password.
4) Allow the system to fill the water bottle.
5) Select ENTER to change from manual to plumbed.
6) Install a new Chemistry Wash bottle and update the count.
7) Perform another system prime as described in steps 3e
through 3h. Set each prime cycle back to the original number.
7. Select the CLEAN PROBE routine.
Note: Condition the photometric sample probe by using a normal
serum sample instead of bleach for the fluid.
8. Perform Daily QC.
the Instrument Log Screen” in Chapter 2
5 - 141
5 - 142
Dimension EXL with LM/EXL 200 System Operator’s Guide Alignments
Chapter 6: Alignments
6-1
Alignments Dimension EXL with LM/EXL 200 System Operator’s Guide
General Alignment Information

Alignments on the Dimension EXL system are performed with the help of
system software. This section contains procedures for aligning the following
instrument components:
• Barcode Scanners
• Cuvette Ring
• HM Module
• IMT Peristaltic Pump
• LOCI Arm
• Photometer
• R1 Reagent Probe
• R2 Reagent Probe
• Reagent Tray
• Sample Probe
Alignment Offsets
Each component is set to a specific position during manufacturing. To
compensate for these variations, the system’s components are corrected to
manufacturing specifications using offset values determined when the
component is aligned.
Printing and Viewing Alignment Offsets

Current alignment offsets are automatically printed each time system power is
turned on. To print or view current alignments, use the following procedure.
Select F7: DIAGNOSTICS > F3: ALIGNMENTS > F8: ALIGN FILE.
Note: The alignment file is longer than what is viewable in one
screen. Use the PgDn and PgUp keys on the keyboard to
scroll through the screen. Select F4: PRNT ALGN FILE to
create a printout. Printing after performing any alignment
will provide a record of current alignment data for reference
or troubleshooting.
6-2
Barcode Scanner Alignment

Note: Complete this procedure using the sample tubes with
barcoded labels and a 9/64 allen wrench (needed only if the
alignment fails).
Note: Perform this alignment if only using barcode labeled tubes.
WARNING: Sample wheel barcode alignment must be completed after

removal and installation of the following components:
sample wheel home sensor, outer or inner barcode scanner,
segment wheel, or the motor/encoder. Failure to do so could
result in misidentification of barcoded sample tubes.
1. With the system in standby, select F7: DIAGNOSTICS > F3: ALIGNMENTS
> F2: SAMPLER > F8: PROBE/BARCODE.
2. Select F5: BARCODE ALIGN.
3. Place barcode labeled tubes in position #5 and position #6 of an empty
segment.
4. Place this segment in position 1 of the sample wheel.
5. Select ENTER.
Note: The system automatically scans the barcode label taking
approximately two minutes to complete.
6. If the following message is displayed: Mechanical align inner barcode
reader clockwise disregard and continue with Step 7.
7. New alignment values are displayed on the lower part of the screen.
Note: To stop an alignment press the SPACEBAR at any time.
8. Compare the values on the screen to the alignment limits in Step a and
Step b:
a. Calculate the SUM of the [outer] and [inner] values on the screen:
(Outer) + (Inner) = _____ include the + and - signs
This SUM must be equal to or more positive than -30.
b. The Interval value (from the lower right corner of the display
screen) must be equal to or more positive than -15.
c. If both alignments pass, skip to Step 9.
d. If either of the above alignment limits fails:
1) Check for proper barcode label placement on the tube. Ensure
that the label is visible through the slot in the segment. Select
F5: BARCODE ALIGN to rerun the alignment. Compare the
new alignment values with the alignment limits noted in Step
a and Step b above.
2) If both alignments pass, skip to Step 9. If either alignment
fails, continue with Step e through Step g.
e. Loosen the two screws that attach the inner barcode scanner
bracket to the baseplate and rotate the scanner bracket fully
clockwise.
6-3
f. Retighten the screws. Then select F5: BARCODE ALIGN to rerun the
alignment.
Figure 6-1: Barcode Scanner Screws
g. Compare the new alignment values with the alignment limits noted
in Step a and Step b above.
1) If both alignments pass, continue with Step 9.
2) If both alignments fail, contact the Customer Care Center -
Technical Solution: Inside U.S.: 1-800-441-9250; Outside U.S.
Refer to the local support team.
9. Select EXIT and follow the messages to remove the barcode labeled
sample tubes in segment #1, position #5 and position #6.
6-4
Cuvette Ring Alignment

Note: Complete this procedure using a 5/64 allen wrench (needed
only if the alignment fails).
2. Ensure lids are fully open to avoid injury while performing maintenance.

3. Select F7: DIAGNOSTICS > F3: ALIGNMENTS > F5: CUVETTE >
F1: START.
4. Visually check the alignment position of the cuvette ring.
a. If an adjustment is needed, continue with Step 5.
b. If the cuvette ring is properly aligned, select EXIT and do not
continue this procedure.
Figure 6-2: Cuvette Ring Plunger
# Description
1 Cuvette Ring
2 Plunger
3 Cuvette Diaphragm
5. Lower the thermal chamber to access the cuvette ring sensor.

6. Push up on the cuvette ring sensor to check that it is fully seated.
6-5

8. Visually inspect the alignment position of the cuvette ring.
a. If the center of the plunger on the heat torch still does not align
with the center of a notch in the cuvette ring, adjust the cuvette
ring sensor using a 5/64 Allen wrench.
b. To adjust the ring to the left, turn the wrench clockwise, to adjust
the ring to the right, turn the wrench counterclockwise.
Figure 6-4: Allen Wrench
9. Select F1: START and visually inspect the position of the cuvette ring.
10. Repeat Step 8 if necessary.
11. Select EXIT.
12. Close the reagent lid.
13. Perform the “Photometer Alignment ” on page 17 of this chapter.
6-6
HM Module Alignments
This procedure includes alignments of parts on the HM module. To completely
align the HM module, perform the following two alignments as well:
• Sample arm to incubate wheel
• R2 reagent arm to incubate wheel
The HM module component alignments consist of the following:
• Incubate and Wash Wheel Alignments:
a. Incubate wheel to transfer opening
b. Wash wheel to incubate wheel
c. Wash probes to wash wheel
• Vessel Transfer Shuttle Alignments:
d. Vessel transfer shuttle to incubate wheel
e. Vessel transfer shuttle to wash wheel
f. Vessel transfer shuttle to load
All six alignments listed above must be checked/performed to align the HM
module components. Use message prompts as they display to help with each
alignment.
WARNING: Ensure lids are fully open to avoid injury while performing
maintenance.

2. See “Removing the HM Incubation Wheel Cover” on page 4 of Chapter 5:
Maintenance.
3. Select F7: DIAGNOSTICS > F3: ALIGNMENTS > F6: HM MODULE.
Aligning the Incubate Wheel to the Transfer Opening

1. Select F7: CHECK ALIGN. The edges of the transfer station and the
incubate wheel reaction vessel slots should be aligned with each other so
that there is an unobstructed path into the incubate wheel.
2. If the alignment is correct, move the cursor down to the Wash Wheel to
Incubate Wheel field and continue to “Aligning the Wash Wheel to the
Incubate Wheel” on page 8 of this chapter.
3. If an adjustment is needed, use F1 and F2 to visually align the incubate
wheel slot to the vessel transfer slot. When this alignment is complete,
Select F8: ACCEPT.
4. After visually performing an alignment, press F7: CHECK ALIGN and
ensure that the component moves and returns to the new alignment
position.
6-7
5. Continue to “Aligning the Wash Wheel to the Incubate Wheel” on page 8

of this chapter.
Table 6-1: Alignment Positions
Alignment Correct Alignment Position
Incubate Wheel to The edges of the transfer station and the incubate wheel slots are
Transfer Opening aligned with each other so that there is an unobstructed path into
the incubate wheel.
Figure 6-5: Incubate Wheel Alignment
Aligning the Wash Wheel to the Incubate Wheel

1. Ensure the HM incubation wheel cover is removed. See “Removing the
HM Incubation Wheel Cover” on page 4 of Chapter 5: Maintenance.
2. Select F7: CHECK ALIGN. The white alignment mark on the wash wheel
and the incubate wheel should be aligned with each other.
3. If the alignment is correct move the cursor down to the Wash Probes to
Wash Wheel field and continue with “Aligning the Wash Probes to the
Wash Wheel” on page 9 of this chapter.
4. If an adjustment is needed, use F1 and F2 to visually align the wash
wheel mark to the incubate wheel mark.
5. Select F8: ACCEPT.
6. Select F7: CHECK ALIGN and ensure that the component moves and
returns to the new alignment position.
7. Continue to “Aligning the Wash Probes to the Wash Wheel” on page 9 of
this chapter.
Table 6-2: Alignment and Correct Positioning
Wash Wheel The white alignment mark on the wash wheel is aligned to the white
to Incubate Wheel alignment mark on the incubate wheel.
6-8
Figure 6-6: Incubate Wheel Alignment
Aligning the Wash Probes to the Wash Wheel

1. Ensure the HM incubation wheel cover is removed. See “Removing the
HM Incubation Wheel Cover” on page 4 of Chapter 5: Maintenance.
2. With the cursor at the Wash Probes to Wash Wheel field, select
F7: CHECK ALIGN.
a. Probe Position:
1) Both wash probe tips should be centered over the white
alignment dots in the wash wheel. If a probe is not centered
over its dot, perform a manual alignment.
2) Use a 3/32 Allen wrench to loosen the two screws that secure
the wash probe holder to the wash probe platform.
3) Move the top of the wash probe until its tip is within the
white alignment marks.
4) While keeping the tip from moving, tighten the two screws
5) Select F7: CHECK ALIGN and check the wash probe tip
alignment to the white dot.
6) When this alignment is complete, press F8: ACCEPT and
continue.
7) Select F7: CHECK ALIGN and ensure that the component
moves and returns to the new alignment position.
b. Probe Height:
1) Each probe tip should be above the white alignment dots on
the wash wheel. If an adjustment is needed, use F1 and F2 to
visually align the height of the wash probes above the white
alignment dots.
6-9
2) If a wash probe tip is not over any position of the white

alignment dot, repeat step a 1 - 7.
Wash Probes The wash probe tips are centered over and above the white
to Wash Wheel alignment dots on the wash wheel.
Figure 6-7: Wash Probe Alignment
Aligning the Vessel Transfer Shuttle to the

Incubate Wheel
1. With the cursor at the Vessel Transfer Shuttle to Incubate Wheel field,
select F7: CHECK ALIGN and follow the message to place a reaction
vessel in the slot of the incubate wheel directly across from the transfer
slot.
2. Depress the vessel shuttle guide solenoid valve plunger to manually
lower the shuttle guide to the reaction vessel and then visually
determine if the guides are centered around the reaction vessel.
3. If an adjustment is needed use F3 and F4 to visually align the vessel
transfer shuttle guides around the reaction vessel.
4. After visually performing an alignment, press F7: CHECK ALIGN and
position.
6 - 10
5. Select F8: ACCEPT and continue with “Aligning the Vessel Transfer
Shuttle to the Wash Wheel” on page 11 of this chapter.
Vessel Transfer Shuttle The edges of the vessel guide on the end of the vessel transfer
to Incubate Wheel shuttle are centered around the top of the vessel in the incubate
wheel.
Figure 6-8: Vessel Transfer Shuttle Alignment
Aligning the Vessel Transfer Shuttle to the Wash Wheel

1. With the cursor at the Vessel Transfer Shuttle to Wash Wheel field, select
F7: CHECK ALIGN. Follow the message to push the reaction vessel all the
way into the wash wheel.
2. Depress the vessel shuttle guide solenoid valve plunger to manually
lower the shuttle guide to the reaction vessel.
a. If the alignment is correct, move the cursor down to the Vessel
Transfer Shuttle to Load field and continue “Aligning the Vessel
Transfer Shuttle to Load” on page 12 of this chapter.
b. If an adjustment is needed use F3 and F4 to visually align the left
edge of the shuttle guide until it just touches the reaction vessel.
3. After visually performing an alignment, select F7: CHECK ALIGN and
position.
Vessel Transfer Shuttle The left edge of the shuttle vessel guide on the end of the vessel
to Wash Wheel transfer shuttle is just touching the vessel in the wash wheel.
6 - 11
4. When this alignment is complete select F8: ACCEPT.

5. Continue with “Aligning the Vessel Transfer Shuttle to Load” on page 12
of this chapter.
Aligning the Vessel Transfer Shuttle to Load

1. With the cursor at the Vessel Transfer Shuttle to Load field, select
F7: CHECK ALIGN.
2. Depress the vessel gate solenoid valve plunger to manually move its
guide around the reaction vessel.
3. While keeping the vessel gate solenoid valve plunger depressed, also
depress the vessel shuttle guide solenoid valve plunger to manually
lower the shuttle guide over the reaction vessel.
6 - 12
Figure 6-10: Vessel Shuttle Solenoid
# Description
1 Valve Plunger Press Here
2 Vessel Shuttle Guide Solenoid
3 Vessel Gate Solenoid
4 Valve Plunger Press Here
a. If the alignment is correct, skip any adjustment instructions.

b. If an adjustment is needed, use F3 and F4 to visually center the
vessel transfer shuttle guides around the top of the reaction vessel.
c. When the alignment is complete, select F8: ACCEPT.
position.
Vessel Transfer Shuttle The vessel guide on the end of the vessel transfer shuttle is
to Load centered over the top of the vessel in the transfer station.
6 - 13
5. Select EXIT and follow the message to remove any reaction vessels
placed on the wheel during the alignment procedure.
Note: Remember to replace the HM incubation wheel cover after all
alignments are complete.
6 - 14
LOCI Arm Alignment

maintenance.

LOCI Arm to Vessel Alignments

Figure 6-12: LOCI Arm Alignment
2. Select F7: DIAGNOSTICS > F3: ALIGNMENTS > F6: HM MODULE >
F6: LOCI ALIGNMENTS.
3. Move the cursor first to the Automatic selection above LOCI ARM TO
VESSEL ALIGNMENTS and select F7: CHECK ALIGN.
4. When prompted, place the LOCI alignment gauge on the incubation
wheel just left of the white dot.
6 - 15
5. Select ENTER.
Note: The HM wheel and the LOCI arm will move through the
auto-align process. When complete, the instrument gives the
opportunity to manually adjust the alignment.
6. Select F8: ACCEPT when complete.
7. Exit to the main operating screen and remember to remove the LOCI
alignment gauge.
LOCI Arm to Detector Alignments

Note: If conducting both LOCI alignments at the same time and the
LOCI to vessel alignment is already completed, skip to Step 3
below.
2. Select F7: DIAGNOSTICS > F3: ALIGNMENTS > F6: HM MODULE >
F6: LOCI ALIGNMENTS.
3. Move the cursor to the Automatic selection as shown below for the LOCI
ARM TO DETECTOR ALIGNMENTS section by pressing the down arrow
button.
4. Select F7: CHECK ALIGN.
Note: If previous alignments were performed, ensure that the LOCI
alignment gauge has been removed, as indicated by the
prompt and press ENTER.
5. When prompted, place the LOCI alignment gauge on the incubation
wheel just left of the white dot. The instrument has placed this position
at the rear of the incubation wheel close to the LOCI module.
6. Select ENTER.
Note: The HM wheel and the LOCI arm will move through the
auto-align process. When complete, the instrument gives the
opportunity to manually adjust the alignment.
7. Select F8: ACCEPT when complete.
Note: If finished, exit to the main operating screen and remember
to remove the LOCI alignment gauge.
6 - 16
Photometer Alignment
1. Ensure that all instrument doors and lids are closed.
2. Select F7: DIAGNOSTICS > F3: ALIGNMENTS > F4: PHOTOMETER >
F3: ARM ALIGN > F1: START.
Note: Do not touch any other keyboard keys until this alignment
has been completed.
3. When the message New alignment is: (old value: ) Do you want to
store? (y/n) displays, the alignment is complete. The alignment is in
progress when the screen plot at the right slowly displays.
Figure 6-13: Photometer Alignment Screen
4. The alignment is acceptable if the new alignment value is between –2

and –10 and the screen shows a U-shape with a straight, flat line along
the bottom of the U.
If the alignment is acceptable, press Y and continue with the next step. If
either the new alignment value or shape of the curve is not correct, press
N and contact the Customer Care Center - Technical Solution: Inside U.S.:
5. Press EXIT to display the Photometric Align screen and select F4: mAU
OFFSET CAL.
6. When the Time on HIGH field on the screen is ≥ 30 minutes, answer the
message with a “Y”. The mAU offset calibration takes approximately
60 seconds.
7. When the alignment is complete, select EXIT.
6 - 17
R1 Reagent Probe Alignments

maintenance.

Three alignments are needed to align the R1 reagent probe in this order:
1) R1 reagent arm to drain
2) R1 reagent arm to target (cuvette)
3) R1 reagent arm to reagent tray
These alignments should be done in the sequence listed above (the order in
which they are presented in this procedure).
2. Select F7: DIAGNOSTICS > F3: ALIGNMENTS > F1: REAGENT. Each of
the R1 reagent probe alignments begins from this screen.
Note: Continue with “R1 Reagent Arm to Drain Alignment” on
R1 Reagent Arm to Drain Alignment

1. Select F6: ALIGN R1 DRAIN.
2. If the probe is aligned correctly, the tip of the probe will be centered
above the hole in the cover of the drain.
Note: If an adjustment is needed, continue with Step 3. If the probe
is aligned correctly, skip to Step 4.
6 - 18
Note: For a better view of the probe position, use the down arrow
key on the keyboard to lower the probe into the drain.
Figure 6-14: Drain Alignment
3. Visually align the probe using the function keys described on the screen.
4. When the probe is aligned, select F8: ACCEPT.
6. Continue with the procedure “R1 Reagent Arm to Target (Cuvette)
Alignment” in this chapter.
R1 Reagent Arm to Target (Cuvette) Alignment

1. Select F7: ALIGN R1 TARGET > F6: INSERT GAUGE.
2. Place the probe alignment gauge into the R1 cuvette access hole. .
3. Select ENTER.
6 - 19
Figure 6-15: Probe Alignment Gauge
4. If the probe is aligned correctly, the probe will be within the flat circled
tip in the center of the alignment gauge and above the gauge. If an
adjustment is needed, continue with Step 5; if the probe is aligned
correctly, skip to Step 6.
Note: The operator should be able to fit a piece of printer paper
between the probe tip and the gauge and be able to feel
resistance without ripping the paper.
CAUTION: Perform the Up/Down alignment first to avoid possible damage to

the probe.
6. When the probe is aligned, select F8: ACCEPT and follow the instructions
as they appear in the message area of the screen to remove the reagent
probe alignment gauge.
Note: Ensure that the component moves and returns to the new
alignment position.
8. Continue with the procedure“R1 Reagent Arm to Reagent Tray
6 - 20
R1 Reagent Arm to Reagent Tray Alignment

1. Select F2: ALIGN CARTRIDGE.
2. Use the right arrow key to move the cursor on the screen to “R1 arm.”
3. Select F5: INSERT GAUGE and follow the messages as they appear on
the screen to insert the reagent tray alignment gauge into the
instrument.
Note: If prompted to remove a reagent cartridge, this same
cartridge must be placed into the instrument at the end of the
procedure.
4. If the probe is aligned correctly, the probe should be centered within the
target circle on the gauge and above the gauge. If an adjustment is
needed, continue with Step 5; if the probe is aligned correctly, skip to
Step 6.
Figure 6-16: reagent Arm Alignment
7. Select Exit and follow the messages as they appear to remove the
reagent tray alignment gauge and return the reagent cartridge to its
original slot in the reagent tray.
Note: If a reagent cartridge was removed, place the same cartridge
in the reagent tray slot from which it was removed. In
addition, record the positions of the cartridges prior to
removal.
6 - 21
R2 Reagent Probe Alignments

maintenance.

1. Align the R2 probe with these four alignments in this order:
a. R2 Reagent Arm to Drain
b. R2 Reagent Arm to Target (Cuvette)
c. R2 Reagent Arm to Reagent Tray
d. R2 Reagent Arm to HM Incubate Wheel
3. Select F7: DIAGNOSTICS > F3: ALIGNMENTS > F1: REAGENT.
4. Continue with “R2 Reagent Arm to Drain Alignment” on page 22 of this
chapter.
Note: Alignments for Up/Down should be performed using
instrument printer paper.
R2 Reagent Arm to Drain Alignment

Note: Complete this procedure using a screwdriver (if needed).
1. Select F1: ALIGN R2 DRAIN.
a. If any part of the R2 probe tip or securing nut is directly above the
hole in the cover of the drain, type n in response to the prompt and
continue with Step 3.
b. If not type “Y” and first perform the “If a Coarse Adjustment (R2
Home Flag) is Needed” procedure.
3. If the probe is aligned correctly, the tip of the probe will be centered
above the hole in the cover of the drain. If a fine adjustment is needed
visually align the probe using the function keys described on screen.
position.
6. Continue with the procedure“R2 Reagent Arm to Target (Cuvette)
6 - 22
If a Coarse Adjustment (R2 Home Flag) is Needed

1. Use a screwdriver to loosen (do not remove) the two alignment bracket
screws.
Figure 6-17: Alignment Bracket Screws
# Description
1 Adjustment screw (Located above the

baseplate under left side of bracket.)
2 Loosen These 2 Screws
2. Use the 9/64 Allen wrench to turn the adjustment screw on the bracket in
the same direction that the reagent probe needs to be moved.
3. Select F7: CHECK ALIGN after each time the adjustment screw is turned.
When any part of the probe tip or securing nut is above the hole in the
cover of the drain, tighten the two alignment bracket screws.
4. Return to Step 3 of the “R2 Reagent Arm to Drain Alignment” procedure.
6 - 23
R2 Reagent Arm to Target (Cuvette) Alignment

1. Select F3: ALIGN R2 TARGET > F6: INSERT GAUGE.
2. Place the probe alignment gauge into the 18th hole from the cuvette
access hole of the cuvette ring.
3. Select ENTER.
Note: There is a small indentation in the baseplate at the 18th hole.
Figure 6-18: 18th Access Hole
Note: The operator should be able to fit a piece of print paper

Note: If the probe is aligned correctly, the probe should be within
the flat circled tip in the center of the alignment gauge and
above the gauge.
4. If an adjustment is needed, continue with Step 5; if the probe is aligned

the probe.
7. Answer the prompt “Additional reagent arm to cuvette alignments
should be checked. Check? (y/n)” by pressing y.
8. Continue with the procedure “R2 Reagent Arm to Reagent Tray
Alignment” in this Chapter.
6 - 24
R2 Reagent Arm to Reagent Tray Alignment

1. Select F2: ALIGN CARTRIDGE.
2. Use the right arrow key to move the box on the screen to “R2 arm.”
3. Select F5: INSERT GAUGE and follow the messages displayed. If
prompted to remove a reagent cartridge, this same cartridge must be
placed into the instrument at the end of this procedure.
4. If the probe is aligned correctly, the probe should be centered within the
target circle on the gauge and above the gauge.
Figure 6-19: R2 Alignment

position.
8. When the probe is aligned, press F8: ACCEPT.
9. Continue with the procedure “R2 Reagent Arm to HM Incubate Wheel
6 - 25
R2 Reagent Arm to HM Incubate Wheel Alignment

1. Remove the HM incubation wheel cover. See “Removing the HM
Incubation Wheel Cover” on page 4 of Chapter 5: Maintenance.
2. Select F4: ALIGN R2 VESSEL.
3. If the R2 arm is aligned correctly to the incubate wheel, the R2 probe will
be centered and above the white alignment dot on the incubate wheel. If
an adjustment is needed, continue with Step 5; if the probe is aligned
Figure 6-20: HM Incubate Wheel Alignment

5. Visually align the probe using the function keys on the screen.
a. F1 and F2 move the incubate wheel clockwise and
counterclockwise.
b. F3 and F4 move the R2 probe in and out.
c. F5 and F6 move the R2 probe up and down.
position.
8. Press Exit and follow the messages as they appear to remove the reagent
tray alignment gauge and return the reagent cartridge to its original slot
in the reagent tray.
WARNING: If a reagent cartridge was removed, place that same cartridge

in the reagent tray slot from which it was removed.
9. Replace the HM incubation wheel cover.
6 - 26
Reagent Tray Alignment

maintenance.

Reagent tray alignments require four alignments that are to be performed in
the left-to-right order that displays on the screen.
2. Select F7: DIAGNOSTICS > F3: ALIGNMENTS > F1: REAGENT > F2:
ALIGN CARTRIDGE.
Note: Inspect the automatic loader channel to see whether the
reagent cartridge is centered. If an adjustment is required,
use the function keys described on the screen to move the
reagent tray clockwise or counterclockwise as needed.
5. Use the right arrow key to move the cursor box to the Auto Loader mode.
Figure 6-21: Reagent Tray
6 - 27
6. Select F5: INSERT GAUGE and follow the messages on the screen to
insert the reagent tray alignment gauge into the instrument.
Note: If prompted to remove a reagent cartridge, this same
cartridge must be placed into the instrument at the end of
this procedure. Record the positions of the cartridges prior to
removal. The Alignment positions are described and shown
in Table 6-7.
Table 6-7: Alignment Positions
Mode Alignment Position
Auto Loader Press F6: CALIB LOADER. There is no alignment position to check. When the
automatic Flex loader stops all movement, the alignment is complete.
R1 Arm Press F1: POS GAUGE. The R1 probe should be above and centered within the target
circle on the gauge. Use the function keys to return to the alignment position.
R2 Arm Press F1: POS GAUGE. The R2 probe should be above and centered within the target
circle on the gauge. Use the function keys to return to the alignment position.
7. The operator should be able to fit a piece of printer paper between the
probe tip and the gauge and be able to feel resistance without ripping
the paper.
9. Use the right arrow key to move to the next mode and repeat Step 6.
10. When the alignment is complete, select F8: ACCEPT.
position.
12. Select Exit and follow the messages that display to remove the reagent
tray alignment gauge and return the reagent cartridge to its original slot
in the reagent tray.
WARNING: If a reagent cartridge was removed, place that same cartridge

in the reagent tray slot from which it was removed.
6 - 28
Sample Probe Alignments

maintenance.

Five sequential alignments are needed to align the sample probe in this order:
1. Sample Probe to Cuvette
2. Sample Probe to Cup
3. Sample Probe to Drain
4. Sample Probe to HM Incubate Wheel
5. Sample Probe to IMT Port
Note: Sample Probe max depth alignment is required for initial
sample probe alignment, but is not routinely performed.
Note: All Up/Down alignments should be performed with
instrument printer paper.
Perform these alignments in the order in which they appear on the Sampler
Arm Alignment screen and are presented here.
Depending on the reason for performing the alignment (part replacement,
troubleshooting), you may need to complete one, several, or all of these
alignments.
2. Select F7: DIAGNOSTICS > F3: ALIGNMENTS > F2: SAMPLER.
Note: Each sample probe alignment begins from this screen.
6 - 29
Sample Probe to Cuvette Alignment

1. Select F1: CUVT ALIGN > F6: INSERT GAUGE.
2. Place the probe alignment gauge into the first cuvette access hole of the
cuvette ring.
3. Select ENTER.
Note: There is an indentation in the baseplate at the sample probe
cuvette access hole.
Figure 6-22: Cuvette Access
Note: If the probe is aligned correctly, it should be positioned above

the gauge and within the small flat circled tip in the center of
the alignment gauge.
4. If an adjustment is needed, continue with Step 5; If the probe is aligned

the probe.
6. When the probe is aligned, select F8: ACCEPT and follow the instructions
as they appear in the message area of the screen to remove the probe
alignment gauge.
position.
8. Continue with the procedure“Sample Probe to Cup Alignment” in this
Chapter.
6 - 30
Sample Probe to Cup Alignment

1. Select F2: CUP ALIGN > F7: CHECK ALIGN.
Figure 6-23: Cup Alignment
# Description
1 Alignment Gauge
2 Adapter
2. Follow the messages as they display on the screen to place the cup
alignment gauge in the top of an adapter in segment #1, position #1
(marked inside the sample area).
Note: If the probe is aligned correctly, it should be positioned above
the gauge and within the target circle of the gauge.

the probe.
Note: After visually performing an alignment, select F7: CHECK
ALIGN and ensure that the component moves and returns to
the new alignment position.
6. Use the right arrow key to move the box on the screen to Segment Inner.
6 - 31
7. Select F7: CHECK ALIGN and follow the messages on the screen to move
the cup alignment gauge into the top of an adapter in segment #1,
position #2.
Note: If the probe is aligned correctly, it should be positioned just
above the gauge, within the target circle. If an adjustment is
needed, continue with Step 8. If the probe is aligned correctly,
skip to Step 9.
10. Select EXIT and follow the messages on the screen to remove the cup
alignment gauge.
11. Continue with the procedure “Sample Probe to Drain Alignment” in this
Chapter.
6 - 32
Sample Probe to Drain Alignment

1. Select F3: DRAIN ALIGN > F7: CHECK ALIGN.
Figure 6-24: Probe Drain Alignment
Note: If the probe is aligned correctly, the probe should be centered

above the drain hole that is closest to the reagent tray.
2. If an adjustment is needed, continue with Step 3. If the probe is aligned
3. Visually align the probe using the F1 and F2 function keys.
4. Select F3: PROBE DOWN for an improved view of the probe position and
to see if it is centered above the drain hole.
position.
7. Continue with the procedure“Sample Probe to the HM Incubate Wheel
Sample Probe to the HM Incubate Wheel Alignment

1. Remove the HM incubation wheel cover. See “Removing the HM
Incubation Wheel Cover” on page 4 of Chapter 5: Maintenance.
2. Select F4: VESSEL ALIGN.
Note: If the sample probe is aligned correctly to the HM incubate
wheel, it is centered above the white alignment dot on the
incubate wheel.
6 - 33
Figure 6-25: HM Incubate Wheel Dot
a. F1 and F2 move the sample probe clockwise and counterclockwise.
b. F3 and F4 move the sample probe up and down.
c. F5 and F6 move the incubate wheel clockwise and
counterclockwise.
6. Replace the HM incubation wheel cover
7. Continue with the procedure “Sample Probe to the IMT Port Alignment”
in this Chapter.
6 - 34
Sample Probe to the IMT Port Alignment

1. Select F7: PORT ALIGN > F7: CHECK ALIGN.
Note: If the sample probe is aligned correctly, it is centered within
and just above the notch on the IMT port.
Figure 6-26: IMT Port Alignment
a. F1 and F2 move the sample probe clockwise and counterclockwise.
b. F3 and F4 move the sample probe up and down.
5. After aligning, select F7: CHECK ALIGN.
6 - 35
Sample Probe Maximum Depth Alignment

Note: Sample Probe max depth alignment is required for initial
sample probe alignment, but is not routinely performed.
CAUTION: Ensure that the sample probe to cup alignment has been
performed before performing this alignment.
1. Select F7: DIAGNOSTICS > F3: ALIGNMENTS > F2: SAMPLER >
F8: PROBE / BAR CODE.
2. Move the box in the Max Depth in: field to the appropriate sample
container.
3. Select F7: CHECK PROBE and follow messages as they display.
4. Set the correct probe depth using the F3 and F4 function keys.
5. Select F7: CHECK ALIGN and ensure that the system moves and returns
to the new alignment position.
Table 6-8: Container and Correct Probe Depth
Container For Correct Probe Depth
Primary Tube Align to the primary tube that sits the highest in the segment. The bottom
edge of the nut on the sample probe should be even with the top of the
primary tube.
PED Align to the pediatric (PED) tube that sits highest in the segment. The sample
probe tip should be above the bottom of the pediatric (PED) tube.
SSC Align to the primary tube/SSC combination that sits the highest in the
segments. The sample probe tip should be above the bottom of the SSC. The
size of the sample tube used during this SSC alignment should now be used
with all SSC samples.
• For processing whole blood samples, always place the SSC in the same
size tube used for the SSC sample probe maximum depth alignment.
Refer to the method IFU for sample handling details.
• For processing serum and plasma, primary tube/SSC combinations that
present the SSC at a lower height may be used only if the SSC is filled with
a maximum of 1.0 mL of sample.
6 - 36
Figure 6-27: Primary Tube
# Description
1 Bottom edge of this nut should be

level with the top of primary tube.
2 Probe
Note: After visually performing an alignment, select F7: CHECK

ALIGN and ensure that the component moves and returns to
the new alignment position.
6. When the probe depth is correct, select F8: ACCEPT.
7. To do another sample container depth setting, repeat Step 2 through
Step 6.
8. Select Exit.
Note: Follow the instructions as they appear in the message area of
the screen to remove the container inserted into segment #1.
6 - 37
6 - 38
Dimension EXL with LM/EXL 200 System Operator’s Guide Troubleshooting
Chapter 7: Troubleshooting
7-1
Troubleshooting Dimension EXL with LM/EXL 200 System Operator’s Guide
Troubleshooting Overview
Help Keys
The Help Keys provide information on:
• A specific screen
• Tasks performed on a screen
• Function keys actions
• A brief procedure for how to perform the tasks or cross-reference to
a procedure in this Operator’s Guide
Table 7-1 shows how to access Help screens.
Table 7-1: Help Screens
Press What Appears
ALT+M This key combination displays active error messages. It does not display error
messages that have been viewed and reset.
Help (from the Displays the screens where help for performing a task is available. The Quick
Operating Menu) Index includes the function key sequence to display the screens from the
Operating Menu.
Help (from any Displays information on how to use the screen and its function keys.
other screen)
SHIFT+Help If the cursor is in a field where data can be entered, pressing this key
combination displays acceptable entries for the field.
ALT+Help Displays a screen that explains how Help works and a list of the ALT key
combinations.
CTRL+Help Pressing this key combination displays a list of information for all operating
condition icons. Scroll down on this page to get information on a particular
icon.
Specifying the Problem

Most problems can be specified by systematically reviewing the major aspects
of instrument problems:
1. What are the indicators of the problem?
a. Alarm
b. Error messages
c. Inaccuracy—when system results are not correct or as expected
d. Imprecision—when system results are not reproducible
2. What is the frequency of the problem?
a. Check the printed test reports for test report messages or HI/LO
results.
b. Check QC results using your laboratory’s quality control guidelines.
c. Display (and print, if required) the instrument’s error log.
3. What major changes have occurred recently with the system?
7-2
a. Has the lab started to use any new methods or manufacturing lot
numbers of existing assays?
b. Has anyone replaced or adjusted any system parts?
c. What type of maintenance (daily, monthly, other) was last
performed on the instrument?
4. What common characteristics do the problems share?
5. Is the problem specific to one method or several? If several, do they have
something (such as wavelength) in common?
Solving the Problem

Once the problem has been specified, solving it usually involves one or more of
the following actions:
• Performing an alignment
• Replacing expired supplies
• Recalibrating any affected assays
• Performing maintenance
• Replacing a component
Customer Care Center - Technical Solutions

If the previous recommendations have been followed but have not resolved
the problem, contact the Customer Care Center - Technical Solution.
The staff at the Customer Care Center - Technical Solution will ask for some or
all of the information listed below, please have it ready when calling.
• Serial number of the instrument
• Software revision currently in use
• Description of the problem
• Any assays affected
• Reagent lot or lots affected and their expiration dates
• Calibrator/verifier product lot or lots used and their expiration dates
• Any data obtained from troubleshooting
• Recent QC data (upper and lower QC limits, group mean and
standard deviation)
• Instrument maintenance log data, including system check data,
instrument maintenance, and troubleshooting history
• The modem number of the instrument for remote access (see
below)
Record information here for future reference
Serial No. _______________
Modem No.______________.
7-3
Remote Access
The Customer Care Center - Technical Solution may ask to remotely access an
instrument using the instrument modem. There are two modes of access:
monitor and control. In monitor mode, the specialist can look at files in the
system’s computer memory and/or see the screens. In control mode, the
Customer Care Center specialist can perform the same keyboard functions as
the operator standing at the instrument. The Customer Care Center specialist
will give specific directions over the telephone to establish the remote link
between the system and the Customer Care Center.
WARNING: Remote access in the control mode may cause unexpected

movement of instrument components. The Customer Care
Center - Technical Solution will ask for permission before
entering the control mode. Before giving permission, the
operator must ensure that the safety precautions listed below
and any additional precautions as directed by the Customer
Care Center - Technical Solution are followed.
• All instrument lids and doors should be closed.
• All instrument cabinet panels should be in place.
• All interlocks should be returned to their operating positions. Do not
bypass any interlocks.
• The remote access warning sign should be placed conspicuously on the
instrument to warn personnel that the instrument is in the remote access
mode.
Remote Control
WARNING: When taking control of an instrument, ensure that instrument
operators are aware that remote access may move
instrument components thereby presenting a hazard to the
operator.
Remote control is used with various types of servers and/or devices. When an
instrument is engaged in a remote control session where VNC software is
resident on an instrument, a notification will be displayed: Exercise caution
while performing activities involving the physical movement of
instrument modules. Please ensure that users stay clear of the instrument.
7-4
Chemistry Troubleshooting
Instrument problems are evident when the system displays an error message.
Chemistry problems, however, may not display an error message and may
become evident only when test results are reviewed.
Refer to “Understanding Test Results” on page 2 of Chapter 3: Sample Reports
for details on how to interpret the messages accompanying test results.
The following tips help prevent chemistry problems:
• Perform scheduled maintenance.
• Calibrate or verify a new lot of Flex reagent cartridges before the current
lot runs out.
• Check the expiration date of the calibrator/verifier in use.
• Use fresh quality control materials and check their expiration dates.
• Be sure that QC values are within the assay range identified for each assay.
• Check for interfering substances that may affect test results (see the assay
IFU).
• Assure proper handling and preparation of samples (pretreatment,
preservative, etc.).
When to Troubleshoot Chemistry Problems

Situations that may require chemistry troubleshooting include:
• Calibration and verification results do not meet specific method
performance guidelines.
• QC results fall outside established limits.
• Several test results are inconsistent with each other.
• A test result is inconsistent with patient history.
How to Troubleshoot Chemistry Problems

To solve a chemistry problem refer to the Quality Control or Specific
Performance Characteristics sections on the assay IFU packaged inside each
reagent cartridge box for specific chemistry information.
Procedures for troubleshooting three common chemistry problem areas are on
the following pages. These problem areas are:
• One or more QC results are out of range.
• Inaccuracy—result obtained is not consistent with patient history.
• Imprecision—test results are not reproducible.
Stop at any point in the procedure when the problem is resolved. If the
problem cannot be resolved, contact the Customer Care Center - Technical
Solutions for assistance. See “Customer Care Center - Technical Solutions” on
7-5
One or more QC results are out of range

1. Check sample cup for sufficient sample volume.
2. Fill a fresh sample cup and repeat the QC test in question.
3. Make fresh QC material.
4. Repeat the QC test using an alternate well by removing and reinserting
the Flex cartridge.
5. Repeat the test using another reagent cartridge from the same lot.
6. Run calibrators/verifiers to check the calibration/verification.
7. Repeat QC tests.
8. Repeat Step 5 through Step 7 using a different reagent cartridge lot.
9. Examine the QC charts for trends, a slow drift of results in one direction,
random outliers, or a sudden shift in results.
10. Repeat System Check.
11. For photometric assays, check the alignment of the sample arm, reagent
probes, and photometer.
12. For chemiluminescent (LOCI) assays, check the alignment of the sample
arm and R2 probe.
13. Check the Instrument Log sheets for recent instrument problems.
Inaccuracy—Result Obtained is Inconsistent With

Patient History
2. Repeat QC tests for the affected assay.
3. Make fresh QC material.
4. Repeat QC test using an alternate well in the same cartridge.
5. Repeat the test using another reagent cartridge from the same lot.
7. Obtain a list of the patient’s medications and check the assay IFU for
known interfering substances.
8. Check for proper sample handling (pretreatment, storage, or
preservative).
9. Check recent test results for that sample to see if other assays also had
suspicious results.
10. Check for proper sample arm and reagent probe alignments.
11. Repeat the test on fresh sample.
7-6
Imprecision—Test Results are Not Reproducible

2. Run five replicates of the same assay on a sample to check precision.
3. Refer to the assay IFU for specific precision limits for each level.
5. Check for proper storage of reagents (temperature, humidity).
6. Check the Instrument Log sheets for any relevant system problems.
7. Check for proper sample probe and reagent probe alignments.
8. Repeat the test on fresh sample.
Printing Filter Data for a Test Result

1. Turn on the DATA password:
a. Select F6: SYSTEM CONFIG > F7: PASSWORD.
b. Type the word DATA (must be in capital letters) and select ENTER.
c. The message: System password: [DATA] method diagnostics: ON
displays in the message area.
2. Select the test result associated with the desired data:
a. Select F2: SAMPLE STATUS.
b. Move the cursor to the sample ID and select F8: TEST RESULTS.
c. Move the cursor to the test result and select F8: FILTER DATA.
d. Select F4: PRINT DATA.
3. When finished, turn off the DATA password.
a. Select F6: SYSTEM CONFIG > F7: PASSWORD.
b. Type the word DATA (must be in capital letters) and select ENTER.
c. The message: System password: [DATA] method diagnostics:
OFF displays in the message area.
7-7
System Check Troubleshooting

When the system check results do not meet specifications, rerun the system
check. If the system check continues to fail, follow the troubleshooting items
below and then rerun the system check. If the problem cannot be resolved,
contact the Customer Care Center - Technical Solution: Inside U.S.:
Resolving Miscellaneous System Check Error Conditions

Table 7-2: System Check Error Conditions
System Error Check

Meaning Resolution
Condition
Asterisk Displays Next Indicates that foaming Rerun the System Check. If the asterisk
to one or more System occurred in one or more of still displays, follow the appropriate
Check Results the cuvettes during the troubleshooting in this section for the
System Check. system that has the asterisk.
Asterisks Display Indicates that an error Select F5: PROCESS CTRL > F6: ERROR
Instead of Max Diff, condition occurred that LOG, or F7: DIAGNOSTICS >
Mean and SD caused the instrument to F6: ERROR LOG and resolve the error
Calculations abort the system check. condition before rerunning the system
check.
Probe Cleaner Failed Indicates that there was Note: Ensure that all other System
insufficient Sample Probe Check results are acceptable
Cleaner or Reagent Probe before troubleshooting this
Cleaner present in the problem.
appropriate drain. 1. Prime the appropriate probe cleaner
from the Pump Prime screen.
2. Check the tightness of the probe
cleaner tubing connections to the
pump and drain.
3. Check that the probe drain and
fittings are not leaking.
4. Check that the probe cleaner tubing
is completely inserted into and
reaches the bottom of the bottle.
5. Check that the correct cleaner
solution is in place.
No System Check A system condition 1. Check the sample status to see if the
Printout prevented the printout. system check is still processing.
2. Check that F1: START was selected
to start the system check.
3. Check that there is not a system
need for an ABS/CHK Flex reagent
cartridge.
4. Check the short sample load list for a
possible short sample in the cup
that contains the ABS solution.
7-8
Entering a New ABS/CHK Carton Value:

Use the Daily Maintenance Routines screen.
1. Select: F4: SYSTEM PREP > F8: DAILY MAINT.
2. Enter the ABS/CHK carton value and select ENTER.
Unacceptable Photometer Ranges

The acceptable Photometer ranges are:
• -2.5 to +2.5 mAU for the 293 nm filter
• -1.5 to +1.5 mAU for all other filters
Rerun the System Check. If the System Check continues to fail, follow the
troubleshooting items listed below and rerun.
Table 7-3: System Check Failure and Resolution Table
Possible Cause To resolve
Stray light entering The reagent lid must be closed and all instrument side panels and doors
must be closed when a system check is processing.
Photometer is Realign the photometer. See “Photometer Alignment ” on page 17 of

misaligned Chapter 6: Alignments.
Dirty cuvette windows Clean cuvette windows. See “Cleaning Cuvette Windows” on page 28 of
Chapter 5: Maintenance.
Source lamp was This will be the cause only if a new source lamp has been installed. Remove
installed incorrectly and reinstall the source lamp. See “Replacing the Source Lamp” on
page 127 of Chapter 5: Maintenance.
Optical filter is dirty or Remove the specific optical filter that is failing, inspect it, and either clean
has become or replace it.
delaminated
7-9
Unacceptable Mean or SD for a Reagent Arm (R1, R2)

The acceptable mean and SD for a reagent arm are:
• Mean = the absorbance value listed on the end flap of the ABS
carton.
• ABS ±12 mAU SD ≤ 3.8
• CHK ±15 mAU SD ≤ 3.8
Rerun the system check. If the system check continues to fail, follow the
troubleshooting items listed below as appropriate and then rerun the system
check.
Using a new lot of ABS/CHK and Display the Daily Maintenance screen and enter the value from
failing to enter ABS/CHK carton the ABS/CHK carton flap into the Carton Value field for the
flap value into the software. ABS/CHK lot.
Loose tubing on the reagent Check the tightness of all tubing connections on the R1 or R2
syringes. reagent pump panel.
Reagent probe is misaligned. Realign the reagent probe. See “R1 Reagent Probe Alignments”
on page 18 of Chapter 6: Alignments and see “R2 Reagent Probe
Alignments” on page 22 of Chapter 6.
Crimped or pinched reagent Check if the reagent tubing is crimped (bent) or pinched.
tubing. Replace any tubing that appears to be damaged.
Reagent probe tip is not Replace the probe tip. See “Replacing a Reagent Probe Tip” on
functioning properly. page 106 of Chapter 5: Maintenance.
Reagent syringe plunger tips Replace both the 500-µL and the 2500-µL reagent syringes on
are not functioning properly. the reagent pump panel for the appropriate pump. See
“Replacing a Pump Syringe” on page 96 of Chapter 5:
Maintenance.
7 - 10
Unacceptable Mean or SD for the Sampler

The acceptable mean and SD for the photometric sampler are:
• Mean = 10% of the assay value listed on the end flap of the ABS
carton.
• ABS ±2 mAU, SD ≤ 0.8
• CHK ±2 mAU, SD ≤ 1.6
troubleshooting items listed below as appropriate and then rerun the system
check.
Not filling the sample cup with Look at the System Check printout and see what ABS/CHK Flex®
ABS from the same lot that the lot number was used for the System Check by the instrument.
instrument used for the System Ensure that the sample cup was filled with ABS from this same
Check. lot number.
Using an old ABS sample. ABS sample older than one hour should be discarded and
replaced with a fresh ABS sample.
Using a new lot of ABS/CHK and Display the Daily Maintenance screen and enter the value from
failing to enter ABS/CHK carton the ABS/CHK carton flap into the Carton Value field for the
flap value into the software. ABS/CHK lot.
Loose tubing on the syringe. Check the tightness of all tubing connections on the sampler
pump panel.
Sample probe is misaligned. Realign the sample probe. See “Sample Probe Alignments” on
Plugged sample probe or dirty Clean the sample probe and drain. See “Cleaning the Sample
sample drain. Probe and Drain” on page 35 of Chapter 5: Maintenance.
Loss of water to the sample Replace any tubing that appears to be damaged. Tighten (or
drain. replace) any loose sample water tubing. If the sample drain
fitting is broken, contact the Customer Care Center - Technical
Solution: Inside U.S.: 1-800-441-9250; Outside U.S. Refer to the
local support team.
Sample syringe plunger tips are Replace both the 100-µL and the 2500-µL sample syringes on
not functioning properly. the sample pump panel. See “Replacing a Pump Syringe” on
7 - 11
Unacceptable Mean or SD for the HM Wash System

Figure 7-1: HM Wash System Check
The acceptable mean and SD for the HM wash system are:
• Mean = 10% of the assay value listed on the end flap of the
ABS/CHK carton ±4 mAU, SD ≤ 1.6
troubleshooting items listed in this section as appropriate and then rerun the
system check.
Unacceptable Mean/SD Possible Causes Resolution
Wash Probe Clogged Stylet or Replace Probe
Vacuum Sensor Tube Pinched Ensure that the tubing is not

Low Mean For Wash pinched.
Probe 1 or 2
Wash Station Pump Failure Ensure that the pump on the
wash station for the probe is
functional.
High Mean for Wash Chemistry Wash Tubing Pinched Ensure that the tubing is not
Probe 1 and 2 pinched or cut.
Wash Probe Tubing Ensure that the wash probe

Disconnected tubing is connected to the
proper vacuum sensor.
Misaligned R2 Probe Check the R2 probe to vessel

SD > 1.6 alignment.
Partially Blocked Wash Probe Stylet or replace the wash

probe.
Unacceptable LOCI Ranges

The acceptable range is 0.001 to 0.144.
Table 7-7: LOCI Failure and Resolution Table
Probable Cause To Resolve
Contaminated LOCI Insert Replace LOCI Insert
Contaminated LOCI Vacuum Cup Replace LOCI Vacuum Cup
7 - 12
Error Messages
The area near the top of the Dimension EXL system screen is used to show only
error messages. The system software has two screens, Active System Errors
and Error Log, to review errors that have occurred.
When the system detects an error condition, it displays an error message in the
error message area, and the alarm sounds.
The system can display only one error message at a time. If more than one
error condition occurs at the same time, the system uses a priority ranking to
determine which one to display.
If system processing stops, reset the instrument by pressing the Reset key to
clear the error message and resume processing.
An error message may have one or more minor error messages associated with
it. These minor error messages provide more specific information about why
the error occurred and are helpful with troubleshooting.
Active System Errors Screen

The Active System Errors screen (F5: PROCESS CTRL > F5: ACTIVE ERROR)
shows all the error messages that have occurred since the last time the Reset
key was pressed. Selecting Reset deletes the Active System Errors list.
This screen shows the priority of the error message, the major error message
itself, and a code that identifies the minor error message that caused the error.
These error log screens may contain a long list, use the cursor and PgDn or
PgUp keys to scroll through this list. To view the error that corresponds to the
code, select F3: SEE MINOR.
Error Log Screen

The Error Log screen shows the error message, code, time each error message
occurred, and any assay/location associated with the error. The error log
contains the last 50 major error messages.
1. Select F5: PROCESS CTRL or F7: DIAGNOSTICS > F6: ERROR LOG to
access this screen.
2. Select F4: PRINT LOG.
Software Error Troubleshooting Help

Software help for troubleshooting an error message is available from the Error
Log screen. To see this software help:
1. Move the cursor to the error message and press either ALT+M or
F5: MORE INFO. The troubleshooting help information in the software is
displayed.
2. Select EXIT to remove the help message from the screen.
Note: Select F6: ERROR CODE and enter the number of a specific
error code to be viewed.
7 - 13
IMT Troubleshooting
IMT Results Troubleshooting
If the IMT results are questionable and no error message is indicated by the
instrument or test report slip, any of the following issues may have occurred:
• QC is out
• Failed delta check on the LIS
• Results are inconsistent for the patient‘s clinical picture
• Abnormal Anion gap
Follow the steps in this section to troubleshoot these situations.
1. Check for insufficient sample in the sample container.
2. Rerun the sample. If the results are still questionable, perform the basic
troubleshooting steps below for Na, K, and Cl results.
For Na, K, or Cl results

1. Roll up the Standard A, Standard B, and Flush fluid bags.
a. Check for sufficient volume of fluid and that the bag fitting is in the
down (toward the tray) position.
b. Check the tubing from each bag to ensure there are no air bubbles.
If necessary, replace the bags.
2. Display the Fluids Prime/Pump Alignment screen and check the IMT
pump alignment. If the IMT pumping rate field is less than 72:
a. Replace the X tubing inside the IMT pump.
b. Prime with Salt Bridge solution.
c. Calibrate the IMT.
3. Bleach the IMT waste tubing. See “Cleaning the IMT Waste Tubing” on
4. Bleach the IMT system. See “Cleaning the IMT System” on page 11 of
Chapter 5: Maintenance.
5. Clean the IMT port.
See “Cleaning the IMT System” on page 11 of Chapter 5: Maintenance.
IMT Error Message Troubleshooting

Before troubleshooting any patient/QC results or IMT error messages, rerun the
sample or IMT calibration. If either is successful, no troubleshooting is needed.
Acceptable IMT Values

Table 7-8: Acceptable IMT Values
Sensor Slopes Standard A Liquid Value Standard A Air Value
Na = 53 to 65 Any value <0.6 Any Value > 0.8

K = 53 to 65 Air value must be at least 2 times the Liquid
Cl = -55 to -40 value.
7 - 14
Clot Check Overview

The system has the ability to check for clots during sample aspiration. The clot
check feature functions with the following sample types: CSF, serum, plasma,
whole blood, urine, and QC (except QC run as part of a calibration). A clot
check is performed during the aspiration of all samples and does not affect
turnaround time, time to first result, or throughput.
The clot check pressure transducer board is mounted underneath the sample
wheel hub. To access the board, open the two front instrument doors. Open
the latch for the pump panel. The right piece of tubing is installed from the
100 µL syringe and is labeled TO PUMP. The left piece of tubing is installed
from the sample probe and is labeled TO SAMPLE ARM.
Clot check functionality has the following Error Codes:

• (864) Sample Probe Clot - unable to clear
• (865) Clot Check Error - sample aborted
• (866) Clot Check hardware failure
• (867) Clot Check Error - hanging clot detected
• (868) Sample probe failed to enter the drain
Follow the ALT+M troubleshooting steps in Dimension software if any of these
errors occur. Once the system detects a clotted sample, the contents of the
aspirated sample is not returned to sample container. The remaining sample is
flushed down the IMT clot check drain during the clot check recovery
sequence.
7 - 15
Figure 7-3: Clot Check Drain
Clot Check also includes a bypass feature which permits the operator to bypass
clot check hardware and run the system without clot check functionality if
needed. Clot check must be re-configured within the software, and bypass
tubing must be installed.
Clot Check Bypass

hazard. Follow safe laboratory biohazard procedures and
chemicals when performing maintenance and
Note: Perform this procedure if it has been determined that the clot
check board has failed and the system must continue to
process without the clot check functionality.
1. With the system in standby, select HOME.
2. Select F6: SYSTEM CONFIG > F8: MORE OPTIONS > F1: CLOT CONFIG.
3. Under Clot Check Hardware Installed, change the selection to NO by
selecting ENTER.
Note: A warning prompt will display at the bottom of the screen:
See Operator’s Guide for bypass warnings and
information. Enter Initials.
4. Enter user initials.
Note: The clot check icon will turn yellow.

hazard. Follow standard laboratory procedures for protection
from and disposal of biohazards and chemicals when
performing maintenance and troubleshooting procedures.
Note: There are two separate pieces of sample tubing to be
replaced with clot check.
6. Select PAUSE.
7 - 16
8. Open the instrument front doors to remove the existing clot check
tubing.
Figure 7-4: Syringe Left Port
# Description
1 Left Port
2 TO Clot Check Board
3 100 µL Syringe
9. Remove the plastic sleeve from the end of this tubing and set it aside for
use later in this procedure.
10. Open the pump panel to access the tubing on the end of the clot detector
board.
11. Slide the plastic sleeve back and remove the tubing from the right and
left sides of the clot check metal fittings.
12. Remove the plastic sleeves from both pieces of tubing before removing
the tubings from the conduit.
7 - 17
13. Remove the sample tubing from the 100 µL syringe by pulling through
the conduit.
14. At the sample probe, gently pull on the sides of the sample cover and lift
it off the probe assembly.
Figure 7-6: Sample Cover Probe Assembly
15. Remove the sample tubing from the sample connection and pull the
tubing up through the conduit.
16. Press the black sheathed end of the new sample tubing onto the sample
probe connection.
17. Remove the plastic sleeves from the end of the sample tubing.
18. Route the other end of the sample tubing down through the corrugated
black plastic conduit until it comes out of the opening on the left side of
the clot check board.
19. Continue routing the tubing through the right side of the conduit all the
way through to the 100 µL syringe.
7 - 18
20. Slide the plastic sleeve back onto the tubing and connect onto the left
port of the 100 µL syringe.
21. Flare the sample tubing if needed. Flare the tubing by inserting the flare
tool from the Spare Parts kit into the end of the tubing that will be
slipped onto the fitting.
22. Slide the sleeve fitting over the tubing and left port of the 100 µL syringe.
Note: The clot check bypass tubing should look like the image
below.
Figure 7-7: Clot Check (with Bypass)
# Description
1 Clot Check Bypass Tubing
23. Close the instrument lids and select PAUSE to turn on the sampling
system.
24. Prime the sample pump by:
a. Selecting F4: SYSTEM PREP > F7: PUMP PRIME.
c. Select F2: SAMPLER to begin priming the sample pump.
25. Check the sample tubing for leaks while the system is priming.
26. Perform a system check and daily QC.
27. With the bypass tubing installed, perform the following steps:
a. Close the instrument lids and select PAUSE.
b. Display the Pump Prime menu.
c. Move the cursor to the Cycles field.
7 - 19
d. Type 3 for the number of prime cycles to be performed.

e. Select ENTER.
f. Select F2: SAMPLER.
g. Check the sample tubing for leaks while the system is priming.
h. Perform a system check and daily QC.
i. Record completion of this procedure in the Instrument Log.
7 - 20
Dimension EXL with LM/EXL 200 System Operator’s Guide Configuration
Chapter 8: Configuration
8-1
Configuration Dimension EXL with LM/EXL 200 System Operator’s Guide
Overview
The procedures in this chapter describe how to configure systems and reports
of the Dimension EXL system to meet the specific requirements of the
laboratory. Typically, these configurations are set at the time of installation
and may not need to be changed again. However, operators may want to set
up configurations and do other customizing to meet day-to-day changes in
workload and laboratory operation.
Siemens Healthcare Diagnostics provides validated instructions for using
certain Emit® assays. Contact the Customer Care Center - Technical Solutions
for a copy of the application sheets.
8-2
Selecting Instrument Options

Select or Change an Instrument Option
WARNING: The system configuration selections have been set to meet
the requirements of the laboratory during instrument
installation. Do not change an instrument option without
approval from the laboratory supervisor.
1. Select: F6: SYSTEM CONFIG.
2. Move the cursor to the required field and select ENTER to change the
information for the field.
Note: If prompted, type the system password and select ENTER to
confirm the change.
Note: Each of the fields and function keys that appear on the
System Configuration screen are described in Table 8-1 and
will vary based on additional modules that may be installed
on the instrument.
System Configuration Menu Screen Fields

Table 8-1: Screen Fields
Field Meaning
Enter Sample Data Indicates which type of Enter Sample Data screen, NORMAL (single samples) or
Mode BATCH (batch samples), displays for entering patient sample information.
*RMS Option ON indicates that RMS module is used. OFF indicates that RMS module is not
Configured used. Applies to the EXL with LM only.
*Automatic ON indicates that empty or expired reagent cartridges will be removed

Cartridge Removal automatically from the instrument. Applies to the EXL 200 instrument only.
*Automatic Rerun ON indicates that the system will rerun an assay if there were system errors
during the initial test processing that were resolved by the system. The assay
will be rescheduled without any operator intervention.
Note: This field must be set to ON to use the Automatic Dilution,
Automatic Repeat for Panics and Automatic Reflex Testing.
*Automatic Dilution ON indicates that the system will rerun the assay using a smaller sample
volume when autodilution conditions are met.
*Water In PLUMBED indicates that the instrument is connected to an external water

purification system.
MANUAL indicates that purified water is being added manually to the
instrument‘s water bottle.
*Waste Out PLUMBED indicates that system chemistry wastes are automatically pumped to
an external waste collection system. MANUAL indicates that these wastes are
collected in the instrument waste bottle and must be emptied by the operator.
*Changing these fields requires entering a password.
8-3
Field Meaning
*Automatic Repeat ON indicates that an automatic rerun of an assay will be run if the test result is
for Panics outside the panic values entered by the operator for that method. See
”Automatic Panic Rerun” in this chapter.
*Automatic Reflex ON indicates that an automatic reflex test will be run if the test result is outside
Testing the reflex limits entered by the operator for that method. See “Automatic
Reflex Testing” on page 10 of this chapter.
*HM Module YES indicates that the HM module is available for use. Both HM fields must be
Configured set to ON.
LOCI Module ON indicates that the LOCI module is available for use.
Configured
Clot Check ON activates clot check for samples and enables the software to take actions if
Configured a clot is detected.
OFF indicates that the instrument will not perform clot check when aspirating
samples. Only the hardware monitoring will be active. The clot check icon will
turn yellow.
*Changing these fields requires entering a password.
8-4
System Configuration Menu Function Keys

Additional configurations can be set using the function keys on the System
Configuration Menu screen. The use of these function keys is discussed in
Table 8-2.
Function Key Use to:
*F1: METHOD Enter/view method-specific information for each assay run on Dimension EXL
PARAM system. See “Entering Method Parameters” on page 33 of this chapter.
F2: DEFINE PANELS Create ten panels with up to 20 assays on each panel. All 20 assays can then be
requested with a single keystroke. See “Creating Panel Keys” on page 43 of this
chapter.
*F3: DATE/TIME Change the date and time. To change the date and time
1. Select F5: DATE/TIME.
2. In the Date field, type the day.
3. Select F2: NEXT MONTH to select the month.
4. Type the year.
5. Move the cursor to the Hour and Minute fields and enter the time.
Note: Use the 24-hour time convention for the hour.
6. To display the date/time as MM-DD-YY rather than DD-MM-YY as in steps 2-3,
select ENTER.
Note: The date time display can not be changed if data is already
entered.
7. Select F1: STORE CHANGES before exiting this screen.
*F4: COMPUTER Set up the Dimension EXL system for the laboratory computer operations. See
“Entering Sample ID Information” on page 58 of this chapter.
To establish communications with an LIS:
1. Select F4: COMPUTER > F4: COMMUNICATIONS.
2. Move the cursor to each field on the screen and select ENTER to change its
setting to the appropriate information for the laboratory.
3. Select F2: STORE CHANGES to store changes before leaving this screen.
F5: IMT ON / OFF Configure the IMT system. Press this function key and the IMT status box at the
top of the screen will change appropriately. “IMT Not Config” in the box
indicates that the IMT is OFF.
F6: SELECT PRINTER Configure the printer, creating the header and setting paper specifications for
printed test reports, and if applicable, creating a custom format for an external
printer. See “Configuring the Printer” on page 51 and “Customizing an External
Printer Report” on page 52 of this chapter.
*F7: PASSWORD Change the system password by pressing the function key and follow the
messages as they display.
F8: MORE OPTIONS Displays the System Configuration Secondary Menu screen.
1. Select F1: CLOT CONFIG to go to the Clot Check Configuration menu.
2. Select F5: SAMPLE AUTO REMOVAL to change sample auto removal time.
3. Select F8: TEMPERATURE to override system temperature warnings.
*Changing these keys requires entering a password.
8-5
Possible Dimension EXL System to LIS Communication

Configurations
Table 8-3: LIS Configurations
Configuration Description
Send Only Data can only be sent to an LIS.
Send/Receive Data can be sent to and received from an LIS.
Send ID/Receive In addition to sending data to and receiving from an LIS,

the system will query the LIS for data when needed.
Clot Check Configuration Menu screen

Table 8-4: Configurations Menu
Field Meaning
Clot Check YES activates clot check hardware.

Hardware Installed
NO deactivates clot check hardware. (Used when clot check software
is de-configured and bypass tubing is installed).
Translate Clot OFF is the default selection and allows Clot Check Err to be
Check LIS Error transmitted through the LIS.
ON transmits the Clot Check Err as a process error.
8-6
Configuring Automated System Check Using CHK

1. Select SUPPLIES > F1: CONFIG ALERTS.
2. Move the cursor to the CHK reagent and enter 10.
3. Select F1: STORE ALERTS.
4. Select: F4: SYSTEM PREP > F8: DAILY MAINTENANCE.
5. Select F8: AUTO SETUP to configure system check to run automatically.
6. Use the left and right arrow keys or the touch screen to toggle between
fields.
a. Enter the Start Time Day field and toggle through the days of the
week, selecting ENTER to set.
b. Toggle to the Start Time field and enter the appropriate time using
a 24 hour clock.
c. To activate, toggle between ON/OFF in the activated field.
7. Select F1: SAVE CHANGES.
8. Select HOME.
Note: The automated system check will not run as programmed if
the system remains on the Daily Maintenance or Daily
Maintenance Auto Run screens.
Note: A series of warning screens appear prior to the automated
system check starting. The warnings appear in three time
intervals: 5 minutes, 1 minute, and a final ten seconds prior
to the scheduled start of the routine. The instrument will also
beep 5 times when the ten second warning is displayed.
8-7
Automatic Cuvette Removal

If the system is idle for a long period, activate the Automatic Cuvette Removal
option. With this option the operator can specify a number of idle hours, after
which all used cuvettes will be removed from the cuvette wheel.
The time period choices for this option are 4, 8, 12, 16, 20, and 24 hours.
To activate Automatic Cuvette Removal:
1. Select: F5: PROCESS CTRL > F8: MORE OPTIONS.
2. Select F5: CUVT AUTO REM until the correct number of hours is
displayed.
Note: The specification remains in effect until changed to OFF or to
a different number of hours.
8-8
Sample Auto Removal

The Sample Status screen has been modified to automatically remove entered
sample assay orders that have been in the instrument longer than the entered
Sample Auto Removal Time.
Entered Sample Auto Removal Time can be set to OFF (default option), or from
1 to 8 hours by selecting F6: SYSTEM CONFIGURATION >
F8: MORE OPTIONS. Select F5: SAMP AUTO REM to change the amount of
hours to remove.
8-9
Automatic Reflex Testing

If an assay result is outside the reflex limit, the system will automatically reflex
the assay that was entered in the Reflex If < and or > field on the Method
Parameters screen for that assay. Only one reflex test can be run per result;
however, if the reflex test’s result is outside of its reflex limits, it can trigger its
own reflex test.
The following general conditions are required for a reflex test to run:
• Sample fluid type must be undiluted serum or plasma.
• No error conditions or non-reportable results due to test report messages
must appear on the test report with the original assay result.
• A reflex test will not be run if it is already in the test list for the sample.
• A reflex test will not be run if a calibration or QC is needed for that assay.
• Sufficient reagent cartridge inventory must be on board the instrument to
perform the reflex test.
• For a Lytes reflex test to run, the IMT system must indicate IMT OK in its
status box.
• If an LIS is being used, it must be capable of accepting test results for
assays that were not requested originally.
WARNING: Ensure that there is enough sample in the sample container

to run not only the requested assays but also any subsequent
reflex tests that may be automatically run.
Setting Up an Automatic Reflex Test

The system performs automatic reflex tests only if this feature has been
activated on the System Configuration Menu screen.
1. Select: F6: SYSTEM CONFIG > F1: METHOD PARAM.
2. Press the method test key for which to enter reflex values and a reflex
test.
3. Move the cursor box to the Reflex fields and enter the less than (<) and
greater than (>) limits that will trigger the reflex test. Any limits can be
entered, even those that are within the “normal” results for the method.
One-sided limits can be entered by entering only one of these fields.
4. With the cursor box now positioned to the right of the Run field, press
the test key for the assay that will reflex automatically when the test
result is outside the reflex limits entered in the previous step. Only one
reflex test is permitted per assay.
Table 8-5: Automatic Reflex Test Chart
If you set The reflex test is automatically rerun when:
Low and high limits The result is outside this range, either above or below it.
Low single-sided limit The result is lower than this limit.
High single-sided limit The result is higher than this limit
8 - 10
5. Select F4: STORE PARAM’S.
WARNING: As with any sample run on the Dimension EXL system, ensure
that there is enough sample in the sample container to run
not only the requested assays but also any subsequent reflex
assays that may be automatically run.
6. To set up a reflex test for another assay, press any arrow key to move the
cursor out of the Run field, then press the test key for the next assay.
To Use Automatic Reflex Test Feature

The Autorerun and Automatic Reflex fields on the System Configuration Menu
screen must both be set to ON.
To Deactivate Reflex Testing for a Specific Assay

1. Enter a 0 (zero) in both the upper and lower reflex limits.
8 - 11
Automatic Panic Rerun

Note: Before activating this feature, check with the LIS
administrator to ensure that the LIS can accept two results for
the same assay.
An automatic rerun of an assay can be performed when the test result is
outside the assay’s panic values as entered by the laboratory.
Setting Up an Automatic Panic Rerun

1. From the System Configuration Menu, configure the Automatic Repeat
for Panics field to ON.
2. Select F6: SYSTEM CONFIG > F1: METHOD PARAM.
Note: To use the Automatic Panic Rerun feature, the Autorerun and
Automatic Repeat for Panics fields on the System
Configuration Menu screen must both be set to ON.
3. Select the method test key for which to enter panic values.
4. Move the cursor box to the Panic row in the Serum/Plasma column and
enter the low and high panic values for that method.
Table 8-6: Automatic Rerun Test Chart
If you set The test is automatically rerun when:
Low and high limits The result is outside this range, either above or below it.
Low single-sided limit The result is lower than this limit.
High single-sided limit The result is higher than this limit.
5. Select F4: Store PARAM’S.
WARNING: Ensure that there is enough sample in the sample container

to run not only the requested assays but also any subsequent
panic repeat tests that may be automatically run.
8 - 12
Automatic Reflex Testing and Panic Rerun Report Slips

When both the automatic reflex and panic rerun features are activated for an
assay, test results might be seen on the printed test report that were not
ordered directly by an operator or downloaded from an LIS.
For LIS users: All results are sent to the LIS.
All of these test results, including those that were not directly ordered by the
operator or downloaded from an LIS, will also be sent to the LIS.
For example, suppose the automatic panic and reflex features have both been
configured to ON and that the Method Parameters screen for CA, PHOS, and
MG have been set up as follows:
• CA has been set up with a single-sided high panic range of 12 and a reflex
range of < 6 and > 9.5 with a reflex test of PHOS.
• PHOS has been set up with a reflex range of < 2 and > 5 and with a reflex
test of MG but has no panic range.
• MG has no reflex range or panic range specified.
The following depicts the report slip and a table of what the system would do
when a CA test result exceeds both its panic and reflex limits.
8 - 13
Figure 8-1: Report Slip
Note: A result with a high panic value on the test report slip has the
letters ”hp“ after it (or ”lp“ for a low panic value). Since two
results are shown because of the automatic panic rerun,
mean, SD, and CV for these results also appear on the test
report. All results are sent to the host computer.
Table 8-7: Automatic Reflex Testing Chart
Why was
Test test run? Test Result
1-CA Original test 13.1 exceeds both the panic and reflex limits for CA.
2-CA Hp rerun This test was run because the 1-CA result exceeded the
from 1-CA panic limits for CA.
3-PHOS Reflex test This test was run because the 1-CA exceeded the reflex
from 1-CA limits for CA.
This test was run because the 3-PHOS 1.2 result exceeds
reflex limits for PHOS. No additional reflex testing will be
4-MG Reflex test done for 4-MG because in this example the MG method did
from 3-PHOS not have a reflex test specified.
HI was reported because all values outside the reference

interval are reported HI or LO.
5-CA Statistics Printed because more than one CA test was reported.
8 - 14
Using Calculated Results

If the Dimension EXL system is connected to an LIS, ensure that the LIS is
capable of receiving calculated test results before turning on any calculated
result. Check with the local LIS consultant.
Calculated results are transmitted only if the Mode field on the Communication
Set Up screen has been set to Send Only, Send ID/Receive, or Send/Receive. See
F4: Computer under “Other System Configuration Options” earlier in this
chapter.
Information about using calculated results:
• Calculated results will not be reported for QC samples, except for
HB1CI.
• All assay results used in the equation for a calculated result must be
error-free for the calculated result to appear.
The equations used in the calculated results software program are listed in the
table on the next page.
To set up calculated results:
1. Select F6: SYSTEM CONFIG > F6: SELECT PRINTER >
F8: CALCULATED RES.
Note: To view the equation used in calculating the result, press
F4: SHOW CALC’N.
2. Move the cursor to the Interval field for a calculated result.
3. Enter the reference interval.
4. Select F3: ON/OFF to turn on that calculated result.
8 - 15
Note: Only those calculated results that are turned on will have
their changes stored.
Note: If the calculated result always appears with a Hi or Lo error
message, check the Interval field entry for that result. If a
calculated result is turned on but no interval is entered, all
reporting of that calculated result will contain a Hi or Lo error
because the system will use 0.0 - 0.0 as the interval.
Table 8-8: Calculated Results Equations and k Values
Result Abbreviations Equation
AGAP Anion Gap Anion GAP (1) (Na + K) – (Cl + CO2)

Anion GAP (2) Na – (Cl + CO2)
Only one AGAP equation can be used at a time.
A/G Albumin/Globulin ALB / (TP – ALB)
BN/C2 BUN/CRE2 (BUN) (k)/CRE2 (BN=BUN, C2 = CRE2) where:

k = 1 if both results are reported in mg/dL
k = 1000 if BUN is reported in mmol/L and CRE2 in µmol/L
BN/EC BUN/EZCR (BUN) (k)/EZCR where:

k = 1000 if BUN is reported in mmol/L and CREA in µmol/L
Note: A new equation was necessary in order to enter a new BN/EC
interval.
BN/CR BUN/CREA (BUN) (k) / CREA where:

k = 1000 if BUN is reported in mmol/L and CREA in µmol/L
FTI Free Thyroxine (TU) (T4) / 100.0

Index
GLOB Globulin TP – ALB
HB1CI Unit Conversion % to mmol/mol:(10.93 x %) - 23.50

mmol/mol to %: (0.918 x mmol/mol) + 2.152
The calculation used will depend on the reporting unit selected.
These calculations are based on the IFCC master equations.
IBIL Indirect Bilirubin TBI – DBI
LDL Calculated LDL CHOL – AHDL – [(k1)(TGL)] where:

k1 = 0.20 when TGL is reported in mg/dL
k1 = 0.46 when TGL is reported in mmol/L
The LDL calculated result will use either HDL or AHDL and TGL
results in the equation, whichever were run on the sample. The
CHOL, AHDL or HDL, and TGL results must be in the same units.
The LDL result will be reported in the same unit.
MA/CR Microalbumin/ (MALB/CREA [CREA (CRE2 (EZCR)]) x 100

Creatinine Ratio MALB must be in the unit mg/L and CREA (CRE2) or (EZCR) must be
in the unit mg/dL. The MA/CR ratio is reported with the unit mg/g.
MBRI MB Relative Index (MMB / CKI) x 100

The MBRI calculated result will use either the MMB or LMMB result
in the equation, whichever was run on the sample.
8 - 16
Result Abbreviations Equation
%FPSA Percent Free PSA (FPSA/TPSA) x 100

FPSA and TPSA must be in the same units. %FPSA will be calculated
only if the TPSA result is within the reference interval specified in
the CSF/Blood field of the TPSA method parameters screen.
%ISAT Percent Iron (IRON x 100) / IBCT

Saturation The %ISAT calculated result will use the IRON result in the
equation, whichever was run on the sample. The IBCT and IRON
results must be in the same units, and the IBCT or TIBC result must
be greater than or equal to the IRON result to have %ISAT
reported. The %ISAT result will be reported with the unit (%).
(k1) (Na) + (k2) (GLUC) + (k3) (BUN) + 9 where:

k1 = 1.86
k1 is the slope of the linear regression of mmol/L of Na to the
calculated osmolality.
k2 = 0.056
k2 converts GLUC results reported in mg/dL to millimolar
OSMO Calculated
Osmolality concentration. If GLUC is reported in mmol/L, then k2 = 1.0
k3 = 0.36
k3 converts BUN results reported in mg/dL to millimolar
concentration. If BUN is reported in mmol/L, then k3 =1.0
9
The number 9 is a constant to account for all other osmotically
active solutes present in the solution.
The OSMO calculated result uses the GLUC result in the equation.
RISK AHDL Risk Factor CHOL / AHDL

The RISK calculated result will use the AHDL result in the equation,
whichever was run on the sample.
UIBC Unbound IBCT – IBCT – IRON

Iron-Binding The IBCT and IRON results must be in the same units, and the IBCT
Capacity result must be greater than or equal to the or IRON result to have
UIBC reported. The UIBC result will be reported in the same unit.
8 - 17
An unused Reference Interval fluid field, such as CSF/Blood for the BUN assay,
may contain the reference interval for a calculated result.
Table 8-9: Reference Interval Fluid Field
Method Fluid Calc Result
ALB CSF/Blood A/G
AHDL CSF/Blood RISK
BUN CSF/Blood OSMO
CHOL CSF/Blood LDL
CRE2 CSF/Blood BN/C2
CREA CSF/Blood BN/CR
EZCR CSF/Blood BN/CR
DBI CSF/Blood IBIL
ECO2 Urine AGAP
EZCR CSF/Blood BN/EC
FPSA CSF/Blood %FPSA
HB1C Urine HB1CI
IBCT CSF/Blood %ISAT
IRON CSF/Blood UIBC
LMMB CSF/Blood MBRI
MALB CSF/Blood MA/CR
MMB CSF/Blood MBRI
TIBC CSF/Blood %ISAT
TP CSF/Blood GLOB
TPSA CSF/Blood TPSA range

in which %FPSA
is calculated.
TU CSF/Blood FTI
8 - 18
Calibration Configuration
Define Calibration Product
1. Select the Calib Alert key on the touchscreen.
2. Select F5: DEF CAL PRODCT.
An alternate procedure would be:
2. Enter Password.
3. Select F5: DEF CAL PRODCT.
Scanning Barcode Data

1. Use the barcode reader to scan the barcode on the calibration product
IFU. This fills all fields on the screen.
Entering Data Manually

1. Select the ENTER key.
2. Type the calibration product name and select ENTER.
3. Type the product lot number and select ENTER.
4. Type the lot expiration date and select ENTER.
5. Use the test keys to enter methods associated with the product. Units for
each test are automatically supplied.
6. Enter the appropriate bottle values in the Level fields.
8. To enter additional levels of the product, change the Level and Fluid
fields and select F7: STORE.
Bottle value units are not converted automatically to the instrument units
when data is entered manually. Use the appropriate units when entering
values.
Edit Calibration Product

3. Select F6: EDIT CAL PRODUCT.
4. Highlight the product to be edited.
5. Select F1: EDIT PRODUCT to display the Define Calibration Products
screen.
8 - 19
6. Use the appropriate function keys to make changes.

Key Function
F1: NEW PRODUCT Use to clear the screen and enter additional products.
F2: DELTE METHOD Use to remove the highlighted assay from the list.
F3: CHG PROD NAME Use to enter a different name in the Cal Product field.
F4: CHG PROD LOT Use to enter a different lot number in the Cal Lot field.
F5: CHG PROD EXP Use to enter a different date in the Product Expiration field.
F6: DELETE LEVEL Use to delete a calibration level.
F7: STORE Stores the edited data.
Note: To add tests to the product, use the test keys, then enter the
bottle values in the appropriate Level fields.
Define Calibration Auto Acceptance Parameters

Use this procedure to specify that an assay calibration or verification will or will
not be accepted automatically. By defining automatic acceptance criteria for a
calibration, you can eliminate the step in calibration processing where an
operator must accept the calibration results.
Siemens has determined default values for slope, intercept and correlation
coefficient (r), as well as standard deviation and maximum negative and
positive bias at each calibrator level. Default parameters are based on the total
error of multiple reagent lots and acceptable instrument variance. Wider
acceptance limits increase the total error of accepted calibration, while
narrower limits may reject calibrations which are in the normal variation of the
assay and system.
8 - 20
CAUTION: Because these values are integral to determining if a calibration is

accurate, it is important to be cautious about changing them.
This table describes the auto acceptance parameters as displayed on the
system:
Table 8-11: Calibration Parameter Chart
Parameter Meaning
Slope Low Lowest acceptable slope value.
Slope High Highest acceptable slope value.
Intercept Close to zero or clinically insignificant. (Intercept 0.000-0.000 is the default value
that turns off intercept as an auto acceptance parameter).
Correlation Lowest acceptable r value.

Coefficient (r)
SD Mean Maximum allowable standard deviation of replicates for each calibrated level.
Max Neg Bias Maximum allowable negative bias (residual) for each calibrated level.
Max Pos Bias Maximum allowable positive bias (residual) for each calibrated level.
F8: Print Prints the information on the screen.
1. Select: F5: PROCESS CTRL > F1: CALIBRATION.

2. Enter the Password and select ENTER.
3. Select F4: AUTO-ACCEPT.
4. Select the method to define.
5. Enter the operator name in Approved By.
6. Select F4: CAAP ON.
Note: This keys toggles between on and off.
7. Review the automatic acceptance parameters.
Note: To change, highlight the parameter and type the new value.
8. The default parameters can be restored by selecting F2: DEFAULT CAAP.
9. Select F7: STORE > F5: PRINT.
Note: To display all active (ON) assays, select F8: SHOW ACTIVE.
8 - 21
10. When F8: SHOW ACTIVE is selected, these print options are displayed:
Table 8-12: Print Options
Key Function
F6: PRNT ALL PARMS Prints all parameters for all assays listed on the screen in
alphabetical order.
F7: PRNT SEL PARMS Prints parameters for the highlighted assay.
F8: PRINT ACT LIST Prints the list displayed on the screen.
Note: If assays are shown on the screen, F6: PRINT ACTIVE

displays. If no assays are shown on the screen,
F8: SHOW ACTIVE displays.
8 - 22
Correlations
Some situations may require that the Dimension EXL system and an alternate
system or method provide comparable results. If it is necessary to correlate the
Dimension EXL system to the alternate method, the Correlation feature
provides a way to adjust results by applying slope and intercept values derived
from a correlation between the two methods.
The correlation feature uses simple linear regression to calculate the
correlation curve y = mx + b where x is the expected result and y is the
observed result. When you store the correlation curve, the applied slope (mA)
and intercept (bA) are calculated as mA = 1/m and bA = -b/m. The applied slope
and intercept, stored in the Correlation Entry screen, are used to calculate a
correlated result using the follow.ing equation: correlated result =
(mA)(uncorrelated result) + b
When the correlation is performed offline, the applied slope and intercept
values (as calculated above) are entered in the Correlation Entry screen.
Correlation is applied only to patient samples and QC. Correlation is not
applied to calibration; therefore, do not adjust calibrator bottle values when
you calibrate a correlated method.
Correlation of the Dimension EXL System with Other

Methods
Adjusting the Dimension EXL system to correlate with another method means
that laboratory results will no longer be the same as those of other laboratories
using the Dimension EXL system.
Before correlation, it is important to properly calibrate or verify the assay on
the Dimension EXL system and the alternate method to ensure that the
systems are currently performing acceptably.
Correlation Study
A split sample correlation study should be run using at least 20 patient samples
spread throughout the assay range of the assay. Do not use quality control
material or calibrators as the sample. Use the observed results from the study
to calculate slope and intercept values for the assay.
WARNING: Run correlation samples simultaneously on both instruments

to minimize error. Do not use control or calibrator samples.
Use only patient samples.
Recommendations for Correlation Samples

It is recommended that a minimum of 20 patient samples be used and that the
results span the assay range of the method as indicated on the Dimension
assay IFU. The Dimension system correlation feature will allow the operator to
enter 50 data pairs.
If the correlation samples are run in duplicate, use the average of the results
obtained.
8 - 23
Result Reporting for Correlated Methods

When a test report includes results for a correlated method, the assay
mnemonic is shown in lowercase letters. See Figure 8-2.
Figure 8-2: Correlation Test Report
Using the Correlation Feature

There are two ways to use the correlation feature:
• System Calculation. Enter the results from the correlation study using the
Correlation screen and let the Dimension EXL system calculate the applied
slope and intercept values. (See “Entering Observed Results for System
Calculation” later in this section.)
• Manual (Offline) Calculation. Using the slope and intercept from the
offline correlation study, calculate applied slope and intercept values. Enter
these new values onto the Dimension EXL system using the Correlation
Entry screen. “Entering Slope and Intercept Calculated Offline” on page 26
of this chapter.
After storing the applied slope and intercept, be sure to establish new QC
ranges for the assay.
Note: When correlating an assay, the reference interval, panic
values, reflex values, and quality control ranges may change.
8 - 24
Entering Observed Results for System Calculation

1. Select F5: PROCESS CTRL > F2: CORRELATION.
3. Select F1: CORRELATE.
Note: It is recommended that a minimum of 20 patient samples be
used and that the results span the assay range of the assay as
indicated in the Dimension EXL method IFU.
4. Select the test key for the assay that to correlate.
a. To view specific IMT Assays:
1) Select the Lytes or Na/K test key.
2) Select F5: NEXT METHOD.
5. Enter the following data for each set of samples processed.
Note: As these results are entered, the slope, intercept, and
correlation coefficient fields are updated automatically and a
plot of the data displays on the screen.
Table 8-13: Correlation Coefficient Fields
Field Enter
Sample Sample ID
Expected Result obtained using comparison method or system
Observed Result obtained using the Dimension® EXL ™ system
Note: When entering data, only the same number of decimal places
as shown on the Method Parameters screen for an assay are
permitted.
6. After entering all the sample results, select F7: SHOW CORREL’D.
Note: The screen now shows the expected and correlated data and
a linear regression plot for the correlated data.
7. Review the information on this screen.
a. Expected and correlated values should now be nearly identical.
b. Statistics should be close to the following:
slope = 1.000
intercept = 0.000
r = 1.000
8. Decide if the information on this screen is acceptable for the laboratory
operations.
a. If the information is acceptable, skip to Step 10.
b. If the information is not acceptable, continue with Step 9.
Note: To delete all data; place the cursor on the line where the first
data entry mistake occurs and press F4: DELETE TO END.
8 - 25
9. Look for possible discrepant result pairs. Delete discrepant result pairs as
determined necessary. To delete a discrepant result pair:
a. Select F7: SHOW OBSERVED.
b. Move the cursor to the result pair line.
c. Select F3: DELETE LINE.
d. Select F7: SHOW CORREL’D.
e. Return to Step 7.
10. Select F6: CORRELATED TO and enter the name of the method or
instrument to which will be correlated the Dimension EXL system.
11. Select F7: SHOW OBSERVED > F8: PRINT to produce a report of the data
entered.
Note: This data will not be able to be viewed after the correlation is
stored.
12. Select F7: SHOW CORREL’D.
13. Select F8: PRINT to produce a report of the correlated data.
14. Select F3: ACCEPT CORR to store the information for the method.
15. Select EXIT to view the Correlation Entry screen.
16. Confirm that the assay range from the Siemens assay IFU is entered in
the Method Parameters screen.
17. Establish and enter new reference interval, panic values, and reflex limits
for the correlated assay.
18. Establish new QC ranges for the correlated method.
Entering Slope and Intercept Calculated Offline

1. Use the correlation slope and intercept from the offline correlation to
calculate applied slope and intercept value.
Applied Slope = 1/Correlation Slope
Applied Intercept = (-1)(intercept)/correlation slope
For Example:
Correlation Slope From Offline Correlation = 1.021
Intercept From Offline Correlation = 1.434
Applied Slope =1/1.021 = 0.979
Applied Intercept = (-1)(1.434)/1.021 = -1.405
2. Select F5: PROCESS CTRL > F2: CORRELATION to display the Correlation
Entry screen.
3. Type a password and select ENTER.
4. Move the cursor to the method to correlate, or press the test key for the
assay.
5. Enter the slope value calculated in step 1 and select ENTER.
6. Enter the intercept value calculated in step 1 and select ENTER.
7. Type the name of the method or instrument which will correlate to the
system.
8. Select ENTER.
8 - 26

for the correlated method.
12. Establish new QC ranges for the correlated method.
Removing a Correlation
If the correlation data for an assay can no longer be used, simply change the
slope and intercept values to 0 (zero):
2. Type the password and select ENTER.
3. Move the cursor to the method, or press the test key for the method.
4. Enter 0 for the slope value and select ENTER.
5. Enter 0 for the intercept value and select ENTER.
for the assay.
9. Establish new QC ranges for the assay.
Printing a List of Correlated Methods

To print a list of methods, with Slope, Intercept and Correlated To data:
2. Type the password and select ENTER.
3. Select F4: PRINT. When the prompt “Print all Methods? (y/n)” appears:
a. To print only correlated methods, type n.
b. To print both correlated and non-correlated methods, type y.
Correlations Date
The F5 function key on the Correlation Entry screen, toggles the display
between “Correlated To” and “Date Correlated”. Selecting
F5: SHOW COR DATE, shows the correlation date where applicable.
8 - 27
Performing Reagent Hydrations

The Dimension EXL system can automatically hydrate reagent cartridge wells.
However, it is possible to select a specific reagent cartridge to be hydrated, and
create specific hydration setup lists, which can be stored in the system and
run.
Pre-programmed setup lists and panel keys can fill out the Inventory/Hydration
screen, schedule and manage peak workload hydration requirements.
Three ways to hydrate reagents are:
• The system hydrates reagents as needed to satisfy the test requests. If
there is calibrated reagent for the assay on board, the system hydrates
wells in the reagent cartridge as needed.
• Create a list of assays to be hydrated using the Inventory/Hydration
screen to control the system hydrations.
• The Inventory/Hydration screen, which enables:
• The creation of pre-programmed setup lists that contain the
number of test equivalents of each specific reagent to be
hydrated, then enter the entire setup list by pressing one key.
• A specific panel of tests to be hydrated using
pre-programmed panel keys, P1–P10, from the keyboard.
• Hydrate the selected assays on the Inventory/Hydration
screen now or at a pre-programmed time by setting up a
timed hydration schedule. “Setting a Timed Hydration
Schedule” on page 30 of this chapter.
Note: Select specific reagent cartridge lots and hydrate a specific
number of test equivalents in those lots.
Hydrating a Specific Cartridge Lot

The Hydration By Lot screen shows the number of available test equivalents of
reagent that are hydrated, un-hydrated, and to be hydrated for each reagent
cartridge lot on the instrument.
The Hydration by Lot screen is used only to pre-hydrate small quantities of
reagent.
1. Select F4: SYSTEM PREP > F2: REAGENT PREP.
2. Move the cursor to the assay lot to be hydrated.
3. Enter the number of tests to hydrate for that assay lot.
4. Select ENTER.
5. Repeat Step 2 through Step 3 until all hydrations are entered.
6. Select F4: HYDRATE to begin hydration.
Note: To delete an entry press the SHIFT+DELETE key combination.
8 - 28
Cancelling a Reagent Hydration

1. Select F4: HYDRATE > F5: DELETE.
2. Select Y to answer the message prompt. Hydrations not yet begun will be
deleted.
Note: F5: DELETE is used for cancelling hydrations that are already
in progress.
Hydrating Using the Inventory/Hydration Screen

The Inventory/Hydration screen shows the number of tests available in the
reagent cartridges on the instrument in the first column in blue. The second
column will have all zeroes in it until hydrations are requested.
1. Select F4: SYSTEM PREP > F2: REAGENT PREP > F6: REAGENT SETUP.
Note: An assay name appears in red if there is insufficient inventory
on the instrument to perform the requested hydrations. Add
another reagent cartridge for that assay.
Note: To print a listing of these assays, press F6: PRINT. Enter Y to
print the entire reagent inventory from the display. Asterisks
to the left of the assay names on the printout indicate which
reagent cartridges must be added to the system for requested
hydrations. Enter N to print only those assays that need
reagent cartridges added.
2. Enter the number of tests to hydrate for each assay using any or all of the
assays listed in.
Table 8-14: Methods
Using How to use it.
Cursor Keys Move the cursor to the assay to hydrate and then enter the
number of tests to hydrate.
Test Keys Press the test key for the assay to hydrate and then enter the
number of tests to hydrate.
Panel Keys Press a predefined panel key, P1–P10, and then enter how
many times this panel will be hydrated.
Pre-programmed Setup Lists Press F1: LOAD SETUP 1 or F2: LOAD SETUP 2 for the
pre-programmed setup list.
3. Select ENTER.
4. Repeat Step 2 through Step 3 until all hydrations have been entered.
5. Select F4: HYDRATE NOW.
Note: If a Timed Hydration is scheduled, and F4: HYDRATE NOW is
pressed, the entire pre-programmed setup will begin to
hydrate.
8 - 29
Setting a Timed Hydration Schedule

1. Select F4: SYSTEM PREP > F2: REAGENT PREP > F6: REAGENT SETUP.
2. Move the cursor to the Day field and select ENTER for the start day. Move
the cursor to the right and select ENTER for the stop day.
Table 8-15: Times Hydration Schedule
Set Day to Select When hydrations will be performed
ONLY Hydrations will be performed only on the next Monday.
Mon to Mon WEEKLY Hydrations will be performed on all future Mondays.
ONLY Hydrations will be performed only on each day through the next
Friday.
Mon to Fri
WEEKLY Hydrations will be performed Monday through Friday of each
week until the hydration period is changed.
ONLY Hydrations will be performed only on each day through the next
Sunday.
Mon to Sun
WEEKLY Hydrations will be performed each day until the hydration period
is changed.
3. Move the cursor to the hour and minute fields.

4. Enter the time for the hydration to begin.
Note: Use the 24-hr clock convention.
5. Move the cursor to the right. Use ENTER to select WEEKLY or ONLY. See
the table above for how this field works with the Day field.
6. Move the cursor to the Activated field and select ENTER.
Note: The Activated field changes to On and the Timer Countdown
field indicates the time remaining until hydration begins.
Note: If a Timed Hydration is scheduled, and F4: HYDRATE NOW is
pressed, the entire pre-programmed setup will begin to
hydrate.
8 - 30
Hydrating Using a Pre-programmed Setup List

Use the Define Inventory/Hydration Setups screen to set up a pre-programmed
hydration list. Up to two setup lists can be defined.
1. Select: F4: SYSTEMM PREP > F2: REAGENT PREP > F6: REAGENT SETUP
> F5: DEFINE SETUPS.
2. Use the test keys on the keyboard or the cursor keys to move the cursor
to the assay to be hydrated.
3. Enter the number of tests you want to hydrate for that assay.
4. Select ENTER.
5. Repeat Step 2 through Step 3 until all hydrations are entered.
6. Select F3: STORE SETUP. To print the hydration setup press F2: PRINT.
a. To use a pre-programmed hydration setup list:
1) From the Inventory/Hydration screen select
F1: LOAD SETUP 1.
2) Select ENTER.
8 - 31
IMT Configuration
Two items can be customized related to IMT processing for laboratory needs:
• Include ECO2 in Lytes test method key
• Specify the time interval for IMT bleach/condition soak
ECO2 Test Method

To include the ECO2 test method when the Lytes test key is selected, do the
following:
1. Select F4: SYSTEM PREP > F3: IMT > F7: IMT CONFIG.
2. Move the cursor to the Select ECO2 with Lytes field.
3. Select ENTER to change the field to ON.
4. Select F8: STORE PARAMS.
Bleach/Condition Soak Interval

The bleach/condition soak interval is used to alert that it is time to clean the
IMT system and replace the QuikLYTE integrated multisensor. Select a number
of days (0 - 30) to elapse between cleanings. The recommended interval is 30
days if performing less than 100 lytes per day. If performing more than 100
lytes per day, the interval is 15 days.
Select the number of days based on the test volume. The higher the volume,
the shorter the interval between cleanings should be.
To specify the bleach/condition soak interval:
1. Display the IMT Configuration Menu.
2. With the cursor in the IMT bleach/condition soak interval days field, type
the number of days to elapse between IMT system cleanings.
3. Select ENTER.
8 - 32
Entering Method Parameters

1. Select F6: SYSTEM CONFIG > F1: METHOD PARAM.
3. To select a test method, select F1: NEXT METHOD or a test key.
Note: To select ABS/CHK: When the Method Parameters screen first
appears, select F1: NEXT METHOD.
4. Move the cursor to the appropriate fields and enter data.
Note: Refer to the tables on the pages that follow for information
about these fields.
8 - 33

Note: To print all parameters select F6: PRINT ALL. Abort the
F6: PRINT ALL printout at any time by selecting any key.
Table 8-16: Method Parameter Fields
Field To Enter Information in the Field
Decimal Places Select F2: NEXT DECIMAL.
Select F3: NEXT UNIT.

Result Units
WARNING: To ensure accurate results after the Result Units
is changed, always recalibrate/reverify the
method before running patient samples.
Standard Vol This field name can be either Standard Vol or Selected Vol.
or Selected Vol When Standard Vol appears, the volume on the screen is the
recommended standard volume of sample for the assay as indicated
in the method IFU.
Selected Vol displays if a volume different from the recommended
standard volume on the method IFU was entered. This volume could
be either:
• A Siemens approved reduced sample volume for the assay, or
• A decreased volume (not approved by Siemens) that is used by
the laboratory. When such volume is used, perform assay
validation in the laboratory for CLIA compliance
WARNING: To ensure accurate results if a new sample

volume is selected, recalibrate/reverify the
assay using the new sample volume before
patient samples are run. Siemens does not
recommend using any assay parameters other
than those published in our product literature.
Recalibration/reverification of the assay is required whenever a
Standard or Selected Vol is changed.
Note: The system printer prints the assay abbreviation on
the test report in uppercase for an assay that is using
the standard volume and in lowercase for an assay
that is using a selected volume.
Note: Standard Vol cannot be changed when the
Calibration Vol field appears beneath it for an assay.
These assays require these two volumes to remain
locked.
Calibration Vol This field cannot be changed. It appears under the Standard Vol field
only for those assays (such as C3, C4, IGA, IGG, IGM) that must use
this volume for their calibrations.
8 - 34
Field To Enter Information in the Field
Auto Dilute Vols Use the keyboard or keypad to enter values for both serum/plasma
and urine samples. Refer to the tables on the pages that follow for
the recommended autodilute AD sample volumes for each
autodilute assay.
Intervals Use the keyboard or keypad to enter the upper and lower limits for
the reference, assay range, and panic intervals for a fluid.
• Reference Intervals:
May be adjusted according to laboratory normal
population.
• Assay Intervals:
Set by Siemens. Only use assay intervals published in
each method’s IFU.
• Panic Intervals:
Can be set using upper and lower limits or can be single
sided. Enter a lower limit to automatically rerun test
results that are lower than this limit. Enter a higher limit
to automatically rerun test results that are higher than
this limit.
Reflex If < or > Use the keyboard or keypad to enter a less than and/or greater than
value which, if exceeded, will trigger the automatic reflex test
entered in the Run field.
To deactivate Reflex for an assay, enter a 0 in both the upper and

lower reflex limits and then select F4: Store Param’s. The Run field
assay remains on the screen, but it will not be reflexed because the
upper and lower limits have been set to zero.
Run Use the test keys to enter the method to be automatically reflexed if
the test result for this assay is outside the reflex limits entered in the
Reflex If field. Only one assay can be entered in this Run field.
LOT ID and (C0 - C4) The lot ID and calibration coefficients (C0-C4) are entered
automatically in these fields by the software following the
calibration/verification of the lot. Some coefficients are constant for
certain assays. Refer to the assay IFU for more information. The
system can hold a maximum of two lot numbers per assay in system
memory.
8 - 35
Automatic Dilutions
The system can perform two types of automatic dilutions:
• Automated Urine Dilutions (AUD) – for BUN, CREA, CRE2, EZCR, PHOS, and
URCA
• Autodilute (AD) – user programmable for urine and serum/plasma samples
Automated Urine Dilutions (AUD) - BUN, CREA, CRE2, EZCR, PHOS,

and URCA
When urine is selected as the sample fluid on the Enter Sample Data screen
and BUN, CREA, PHOS, or URCA tests are requested, the sample is
automatically diluted with water by the instrument to make a times 10
dilution. The test results for BUN, CREA, PHOS, and URCA urine samples are
then automatically calculated and printed out using the times 10 dilution. For
EZCR or CRE2, urine samples are automatically diluted 1:20 with the
Dimension system water (1 part urine sample and 19 parts water). Test results
for EZCR or CRE2 on urine samples are then automatically calculated and
printed out using the times 20 dilution. If the AUD test result is outside of the
urine assay range for the method, the operator must prepare a manual
dilution. For example, if a times 3 dilution of the sample is manually prepared
and a dilution factor of 3 is entered on the Enter Sample Data screen, the
instrument will make a times 30 dilution for BUN, CREA, PHOS, or URCA and a
times 60 dilution for EZCR or CRE2 of the sample. Test results are then
automatically calculated and printed out using the appropriate dilution.
Autodilute (AD)
Once the autodilute Method Parameters are entered and the system is
configured to autorerun and autodilute, the Dimension EXL system
automatically performs sample dilutions whenever the calculated result is
above the assay range, or the absorbance of the sample and reagent exceeds
the upper absorbance limit for the assay. To perform the automatic dilution,
the system aspirates a reduced sample volume (similar to the way a manual
dilution would be made). The dilution ratios are based on incremental sample
volume adjustments.
The Dimension EXL system does not perform dilutions based on the Dilution
field on the Enter Sample Data screen – this field is used for convenience when
the instrument calculates the results of the manual dilutions. (If a number is
entered in the Dilution field, the Dimension system will not autodilute the
sample.) For HCG and LHCG and the above AUD only, entering a number in the
Dilution field will not disable automatic dilution.
To configure the Dimension EXL system autodilute feature, first activate both
the autodilute and autorerun features on the System Configuration screen.
1. If either the Automatic Rerun or Automatic Dilution fields is off, move the
cursor to the field and select ENTER to change the setting to ON.
2. When both fields are on, select F1: METHOD PARAMETERS. Type the
password and select ENTER.
8 - 36
3. Select the test key of the first method to edit and highlight the first
autodilute volume field.
4. Enter the proper autodilute volume for each sample type. Select
F4: STORE PARAM’S or F5: STORE & PRINT before exiting or choosing
the next method.
Note: To use the Autodilute (AD) feature, the Autorerun and
Autodilute fields on the System Configuration Menu screen
must both be set to ON.
Note: If the system automatically dilutes a sample, the word
“Diluted” appears next to the assay on the printout. If the
sample was diluted and the result is still above the assay
range for the assay, the message “assy rng/dilu” will appear
next to the assay. In this case a manual dilution should be
performed to determine the correct result.
8 - 37
Recommended Autodilute (AD) for Urine Samples

To use the autodilute feature for urine samples, you must enter the
Recommended AD Sample Volume from the table below in the urine portion of
the Auto Dilute Vols field on the Method Parameters screen.
Table 8-17: Recommended Autodilute (AD) Sample Volumes for Urine Samples
Standard Recommended
Dilution Other Qualified AD
Method Sample AD Sample
Factor Sample Volumes (µL)
Volume (µL) Volume (µL)
CA 5 2 2.5 3, 4
GLUC 3 2 1.5 —
MALB 17 2 8.5 —
UCFP 10 5 2.0 —
AMPH 300 6 2 3.0 semi-quantitative only
BARB 10 2 5.0 semi-quantitative only
BENZ 10 2 5.0 semi-quantitative only
COC 150 12 2 6.0 semi-quantitative only
COC 300 12 2 6.0 semi-quantitative only
EXTC 300 13 2 6.5 semi-quantitative only
EXTC 500 8 2 4.0 semi-quantitative only
METH 6 2 3.0 semi-quantitative only
OPI 300 12 6 2.0 semi-quantitative only
PCP 14 2 7.0 semi-quantitative only
THC 13 3 4.3 semi-quantitative only
(Standard Sample Volume)

Dilution Factor =_________________________________
(Recommended AD Sample Volume)
8 - 38
not only the requested tests but also any subsequent reflex
tests that may be run automatically.
Recommended Autodilute (AD) for Serum/Plasma Samples

To use the autodilute feature for serum/plasma samples, you must enter the
Recommended AD Sample Volume from Table 8-18 in the serum/plasma
portion of the Auto Dilute Vols field on the method’s Method Parameters
screen.
Table 8-18: Recommended Autodilute (AD) Sample Volumes for Serum/Plasma Samples
Sample AD Sample Dilution Other Qualified AD

Method Volume (µL) Volume (µL) Factor Sample Volumes (µL)
ACP 24/cuvette 5 4.8 2, 4
ACTM 4/cuvette 2 2.0 —
AHDL 3 2 1.5 —
ALB 5 2 2.5 3, 4
ALC 3 2 1.5 —
ALDL 3 2 1.5 —
ALP 7 3 2.3 2, 4
ALPI 7 3 2.3 24
ALT 35 10 3.5 2, 5, 7, 8, 12, 15
ALTI 35 10 3.5 —
AMON 53 26 2.0 10, 13, 31, 40
AMM 44 22 2.0
AMY 14 7 2.0 12
AST 40 20 2.0 2, 5, 10
BUN 3 2 1.5 —
CA 5 3 1.7 2, 4
CCRP 12 2 6.0 —
CHOL 3 2 1.5 —
CKI 14 2 7 —
CRBM 3 2 1.5 —
CRE2 20 10 2.0 —
a = The HCG and LHCG methods use an additional 10-fold dilution prior to taking the auto
dilute sample. Therefore a 2 µL autodilute sample for HCG or LHCG is equivalent to a 1:200
dilution. The instrument does calculations automatically.
b = For autodiluted HCG and LHCG results > 200,000 mIU/mL [IU/L], prepare a manual
dilution and enter the appropriate dilution factor on the Enter Sample Data Screen. The
instrument does calculations automatically.
8 - 39

CREA 20 10 2.0 5, 8, 15
CRP 3 2 1.5 —
DBI 10 5 2.0 —
ETOH 9 3 3 —
EZCR 6 2 3.0 —
FERR 40 2 20.0 —
FOLA 10 2 5.0 —
GENT 3 2 1.5 —
GGT 32 16 2.0 4, 8, 14, 18, 20
GLUC 3 2 1.5 —
HCG,a,b 40 2 200.0b —
IBCT 25 12 2.0 —
IGA 10 2 5.0 —
IGG 10 2 5.0 —
IGM 10 2 5.0 —
IRON 40 20 2.0 —
LA 4 2 2.0 3
LDI 8 2 4 —
LHCGa,b 40 2 200.0b —
LIDO 6 2 3.0 —
LIP 4 2 2.0 —
LIPL 3 2 1.5 —
LMMB 60 30 2.0 —
MBI 20 5 4 —
MMB 60 30 2.0 —
MYO 20 2 10.0 —
PHNO 4 2 2.0 3
PHOS 3 2 1.5 —
PTN 4 2 2.0 3
8 - 40

SAL 15 5 3.0 8, 10
T4 16 4 4.0 3,5,7,10
TBI 10 5 2.0 —
TGL 4 2 2.0 —
THEO 4 2 2.0 3
TOBR 3 2 1.5 —
TP 15 8 1.9 5, 7, 10
TPSA 40 2 20 —
UCFP 10 5 2.0 —
URCA 17 5 3.4 —
VB12 12 4 3.0 —
VALP 3 2 1.5 —
If an autodilution is not performed for results on these assays, here are

possible reasons why:
• No reagent from the last calibrated reagent lot for that assay is on board.
• No calibrated reagent for that assay is on board.
• The Flex reagent cartridge needs to be hydrated.
• A "reagent prep" error message occurred.
• Autorerun was not turned on.
• Autodilute volume was not entered or stored.
The autodilute (AD) feature was not tested on serum/plasma samples for the
following methods:
• MG, NAPA, PALB, PCHE, PROC, RCRP, and VANC because the normal sample
size is 2 µL.
• IRON due to lack of samples above our assay range.
8 - 41
not only the requested tests but also any subsequent reflex
tests that may be automatically run.
Recommended Autodilute (AD) Sample Volumes for Reduced Sample

Volumes of Serum
To use a Siemens approved reduced sample volume for any of the following
methods, enter the Recommended AD Sample Volume from the table below in
the serum/plasma portion of the Auto Dilute Vols field on the Method
Parameters screen.
Table 8-19: Recommended Autodilute Sample Volumes for
Reduced Sample Volumes of Serum/Plasma Samples
Reduced Recommended
Dilution
Method Sample Volume AD Sample
Factor
(µL) Volume (µL)
ALTI 20 10 2
AMY 10 5 2
AST 20 10 2
CREA 15 10 1.5
GGT 15 10 1.5
IRON 25 N/A N/A
TP 10 5 2
URCA 10 5 2
not only the requested tests but also any subsequent
autodiluted tests that may be automatically run.
8 - 42
Creating Panel Keys

1. Select F6: SYSTEM CONFIG >F2: DEFINE PANELS.
2. Select F1: EDIT NEXT until the number of the panel to be created/edited
appears on the Edit Panel line.
3. Use the test keys to add tests to the panel.
Note: A maximum of 20 tests can be assigned per panel key.
To remove a test from the panel:

1. Move the cursor to the test.
2. Select F4: DELETE TEST.
8 - 43
HIL Feature
Note: If the Dimension EXL system is connected to an LIS, ensure
that the LIS is able to receive results for tests it did not request
originally. Check with the local LIS consultant.
The HIL feature, which is based on the spectral characteristics of a serum or
plasma sample, provides an index that can alert to potential interference from
hemolysis, icterus, and lipemia in the sample, where:
H = hemoglobin resulting from lysis of red blood cells
I = icterus resulting from endogenous bilirubin
L = lipemia or turbidity caused by insoluble lipids
The HIL feature can be programmed to run automatically in an Operating
Mode that best suits the needs of the laboratory, or by request on individual
samples. Once programmed, the instrument automatically pipets 20 µL of
sample into an empty cuvette along with system water. Spectral absorbance
measurements, taken at 405nm (hemoglobin), 452nm (bilirubin), and 700nm
(turbidity), are used to generate a sample-specific HIL Index. The HIL Index
appears on the report slip as a three-digit value where:
• 1st digit = H index
• 2nd digit = I index
• 3rd digit = L index
Each index value correlates to an approximate concentration range in mg/dL
for each of the potential interferents, as specified in Table 8-20. HIL is not
processed if the maximum of 36 tests for a sample are ordered.
Table 8-20: HIL
H I L
Index
Hemoglobin (mg/dL) Bilirubin (mg/dL) Intralipid ™ (mg/dL)
1 H ≤ 25 I ≤ 2 L ≤ 25
2 25 < H ≤ 50 2<I ≤ 5 25 < L ≤ 50
3 50 < H ≤ 200 5 < I ≤ 20 50 < L ≤ 200
4 200 < H ≤ 300 20 < I ≤ 40 200 < L ≤ 600
5 300 < H ≤ 500 40 < I ≤ 60 600 < L ≤ 1000
6 500 < H ≤ 1000 60 < I ≤ 80 1000 < L ≤ 3000
8 - 44
The following general conditions are required for HIL to be run automatically:
• Sample must be serum or plasma.
• Sample must be undiluted (dilution does not eliminate spectral
interference).
• Operating mode must be set to ON or AUTO-ON.
• If the operating mode is AUTO-ON, Alert Index values between 2 and 6
must be entered in the HIL Setup screen.
• Sample Mode must be primary tube, bar code tube, sample cup or SSC (as
specified in the selected operating mode).
• HIL will not run automatically in the "limited cup - no level sense" (sample
volume may be limited).
HIL Alert Index Values

HIL Alert Index values are used to specify the concentration range at which
interference may be observed. Customize these values to meet the needs of
the laboratory, using interference information from the Siemens assay IFU, the
laboratory testing, or other sources to guide in selecting HIL Alert Index values.
Consider the following before selecting values and implementing the HIL
feature:
• The maximum effect of a potential interferent may vary based on the assay
and the amount of analyte present.
• The laboratory's individual patient population should be considered when
determining if a potential interferent is clinically significant.
When the operating mode is set to auto-on the test report displays the "HIL
Interf" message if any of the measured HIL index values (H, I, or L) is greater
than or equal to the corresponding Alert Index value entered for the method
(See “HIL Setup” on page 46 of this chapter). If the "HIL Interf" message is
displayed, follow laboratory procedures for reporting results when the sample
is hemolyzed, icteric and/or lipemic.
WARNING: Do not use the results of this feature to report hemoglobin,

bilirubin, or triglyceride concentrations.
8 - 45
HIL Setup
To set up the HIL feature, select an Operating Mode. The selections for
operating modes are listed in Table 8-21. If the mode is "AUTO-ON -Tubes,
Cups, SSCs" or "AUTO-ON -Tubes, Cups", also enter HIL Alert Index values.
not only the requested tests but also any subsequent tests
that may be automatically run.
To specify parameters for HIL setup:
1. Select F5: PROCESS CTRL > F8: MORE OPTIONS.
3. Select F6: HIL SETUP.
4. Select F1: NEXT MODE to display the Operating Mode that best suits
laboratory needs.
Table 8-21: Operating Modes
Operating Modes
AUTO-ON -Tubes, Cups, HIL is run automatically when an assay with an alert index between 2 and
SSC's 6 is requested and the sample mode is primary tube, bar code tube,
sample cup or SSC. The test report displays the "HIL Interf" message for an
affected assay if any of the measured HIL index values is greater than or
equal to the corresponding Alert Index for that assay.
AUTO-ON Tubes, Cups HIL is run automatically when a method with an alert index between 2
and 6 is requested and the sample mode is primary tube, bar code tube or
sample cup. The test report displays the "HIL Interf" message for an
affected assay if any of the measured HIL index values is greater than or
equal to the corresponding Alert Index for that assay.
ON HIL is run automatically and reported for all serum and plasma samples
when the sample mode is primary tube, bar code tube, sample cup or
SSC. The test report does NOT display the "HIL Interf" message for an
affected assay.
OFF HIL is not run automatically for any sample. However, the operator can
request HIL by including it in the list of tests requested by LIS or by
pressing the HIL test key when ordering tests manually. The test report
displays the HIL index, but does NOT display the "HIL Interf" message for
an affected assay.

6. If the Operating Mode is AUTO-ON, enter HIL Alert Index values:
a. Press the method key for which to enter values or position the
cursor on the row for the method to be configured.
b. Enter values (2 through 6) for H, I, and L to specify the
concentration range at which interference may be observed.
c. To indicate that no interference was observed at an approximate
concentration of 1000 mg/dL (H), 80 mg/dL (I), or 3000 mg/dL (L),
enter zero (0) for the Alert Index value.
8 - 46
d. To discontinue using a specific Alert Index, enter zero (0) in the

appropriate index field for that assay.
e. To deactivate the HIL feature for a assay, enter zero (0) in all the
Alert Index fields.
f. To prevent inappropriate flagging of samples which are not
hemolyzed, icteric or lipemic, the system does not accept an Alert
Index value of 1.
7. When all required HIL Alert Index values are entered, select F2: STORE.
To view a list of methods and HIL Alert Index values:
a. Select F5: SHOW ALL to display all HIL eligible assays.
b. Select F5: SHOW ACTIVE to display only assays with stored alert
indexes.
8. To print a list of assays and HIL Alert Index values, select F4: PRINT.
8 - 47
Configuring Touchscreen Alert Keys

The 5 Alert Keys on the touchscreen change color to warn of operating
conditions requiring a quick response. Before this feature can be used, enter
specific settings for these four keys:
• STAT Status
• Supplies
• Calib Alert
• QC Alert
The Sample Alert key uses automated test rerun features which are configured
individually.
Configuring the STAT Status Alert Key

Three conditions can trigger a STAT Status alert:
• STAT sample is complete, but no result. In this situation, the alert key
turns red. The sample information appears in red on the Show All and
Show Completed display modes on the STAT Samples screen.
• STAT sample not run. In this situation, the alert key turns red. The sample
information appears in red on the Show All and Stats Not Started display
modes on the STAT Samples screen.
• STAT sample completed. In this situation, the alert key turns yellow. The
sample information appears in blue on the STAT Samples screen.
Configure the STAT Status feature to alert to any or all of these conditions.
1. Select the STAT Status alert key to display the STAT Samples screen.
2. Select F4: CONFIG ALERTS.
3. Move the cursor to the required field. Select ENTER until the choice is
displayed or type the required number for time fields, then select ENTER.
8 - 48
4. Select EXIT.
Table 8-22: Status Configuration Screen Fields and Selection Choices
Field Choices
Sound audio alarm when any STAT OFF alarm will never sound
alert is triggered ON alarm will sound for all configured alerts
Alert when a STAT sample is OFF alert key will not turn yellow when sample processing is
available finished.
ALWAYS alert key will turn yellow when any STAT sample is
finished processing.
SELECTABLE allows the operator to select a specific sample and
select the F8: Complete Alert key:
• If the sample line is white (alert OFF) when F8 is selected, it
turns yellow while processing and blue when finished.
• If the sample line is yellow when F8 is selected, it turns white
(alert OFF).
Alert when a STAT sample is OFF alert key will not turn red when sample processing is finished
available but has an error with no with an error and no result
result ON alert key will turn red when sample processing is finished with
an error and no result
Alert when a STAT has been OFF alert key will not turn red for samples not started
entered but not run in a specified ON alert key turns red if a sample does not start processing within
time the specified time period
Time from STAT entry to alert - in Can be used only if the previous entry is ON. Enter the number of
minutes minutes (1-60) a STAT request can wait before the Not Started
alert is triggered.
Time for STAT alerts to be Enter the number of minutes (1-120) that an alert will be
displayed - in minutes displayed on the STAT Samples screen. After the time has elapsed,
the information is removed from the display.
Configuring the Supplies Alert Key

Pressing the Supplies alert key displays the Reagent Cartridge Alerts screen.
When the number of tests available is equal to or less than the Alert At
number, the Supplies alert key changes color to yellow.
To configure a test method for the Supplies alert:
1. Select F1: CONFIG ALERTS
2. Move the cursor to the "Alert At" field for the test method to configure.
3. Type the number of tests.
4. Select ENTER.
Note: If the "Alert At" number is zero, the Supplies alert will not
apply to the method.
5. When finished configuring methods, select F1: STORE ALERTS.
8 - 49
Configuring Calibration Alerts

1. SELECT CALIB ALERT.
2. Select F4: CONFIG ALERTS.
3. For the Alert parameters, move the cursor to the required field and select
ENTER to toggle between ON and OFF.
4. Move the cursor to the Time parameter.
5. Enter a number between 1 and 240 (hours) to define the time interval for
expiration.
6. Select Exit to store changes.
Configuring QC Alerts
1. Select QC Alert.
2. Select: F4: CONFIG ALERTS.
3. For each parameter, move the cursor to the required field and select
ENTER to toggle between ON and OFF.
4. Enter a number between 1 and 240 (minutes) to define the time interval
for expiration.
Note: This is done only if the operator turns ON the Alert when QC
expires.
5. Select Exit to store changes
8 - 50
Configuring the Printer

Use the Printer Set Up screen to create a report title, set system printer report
printout specifications, and configure the printer(s).
1. Select F6: SYSTEM CONFIG > F6: SELECT PRINTER.
a. If using an external printer as well as the system printer, set the
system printer to Online- No Test Reports, and the external printer
to Online - Test Results Only.
Table 8-23: Printer Configuration Screen Field Names and Explanations
Field Explanation
Report Title This creates the header that appears on your printed test report.
Enter a title for the report (up to 30 characters).
System Printer Indicates the status of the system printer. Select F1: SYS PRINTER
to select another status.
Spacing between reports Enter the number of centimeters of blank paper that will be
between printed test reports.
Minimum number of lines Enter how many test result lines will appear in all test reports.
External Printer Indicates the status of the external printer. Select F2: EXT PRINTER
to select another status.
Mode May be set to Serial or Parallel depending on the type of external

printer that is used.

Note: To configure all test reports to be the same length, enter the
maximum number of tests that are typically run on a sample.
8 - 51
Customizing an External Printer Report

1. Select F6: SYSTEM CONFIG > F6: SELECT PRINTER > F6: REPORT SETUP.
Note: The system software has a default report layout with preset
column and line values to create a suitable report.
2. Select F1: DEFAULT SETUP > F8: STORE CHANGES.
Customize the External Printer Report

1. On the Print Test Results—Format screen, use the arrow keys to scroll
down through four sections of fields and type/edit the information as
required.
Note: All information that appears in white can be edited.
Note: See Figure 8-3 on page 53 of this chapter for an example of a
printed report.
Create an External Printer Report

Below are some additional points about customizing the four sections of an
external printer report:
Table 8-24: Printer Report Headers
Header Description
Report Title & Banner The date and time the report was printed are placed on the last line of the
label.
Patient Header The label section fields can be chosen from any information on the Enter
Information Sample Data Screen
Test Result Line - Header This section consists of only two lines, both use the same line and column
positioning data. This section sets the headers for the data.
Test Result Line - Data The Data Item column contains results information that can be selected for
the report.
Note: The field “Chemistry” means that the full name of the method
(such as Triglyceride) will be printed on the report; the field
“Test” means that the method abbreviation will appear on
the report.
8 - 52
External Printer Format - Report Slip Example

Figure 8-3: Report Slip
The above settings should produce the output shown in Figure 8-4.
8 - 53
Figure 8-4: Output
Note: Follow the dashed lines to view how the line and column
specifications relate from the format to printout.
Note: Use “-1” in the Column field to prevent printing.
Note: To align the title entries use spaces. The “^^^^” in Figure 8-4
indicate spaces added using the space bar to center the titles.
8 - 54
Using the Result Monitor Feature

Select F5: PROCESS CTRL > F8: MORE OPTIONS > F2: RSLT MONITOR.
Each Dimension EXL system can collect its absorbance readings by assay and
lot of reagent, and then use this data to establish instrument-specific limits for
that assay. Any test result that exceeds these limits on the particular
Dimension EXL system will generate an “abnormal assay” (abnl assay) flag on
the test results printout. If this occurs, the result should not be reported and
the sample should be rerun. This feature is not available for all assay.
The Result Monitor screen is divided into two sections. The left side (Limits) is
used to activate an assay and to enter/change assay-specific limits. The right
side (Accumulated Results) will be filled in by the system for each assay that
has been activated.
Limits Side
Includes an A column and a B column, depending on whether the assays use
one or two monitoring checks. The fields in each column define the limit using
either percentage or SD limits. Above Mean Factor numbers are given as a
percentage factor of the mean absorbance result. For the Mean Plus/Minus SD
fields, the number entered is the factor times the SD to define the limit around
the mean.
Accumulated Results Side

The Reagent Lot ID field displays the lots active on the instrument. To view
accumulated results for a second reagent lot, use the F2 key to switch lots. The
Status field shows whether the feature is actively checking results or collecting
initial baseline data. The monitor columns display the mean, SD, lower and
upper limits around the mean, and a count of the number of results checked
and flagged. The results count does not begin until the baseline data are
accumulated and the status is active.
F4 Zero Data Function Key

Do not press F4: ZERO DATA without first checking with your lab supervision
or the Customer Care Center - Technical Solution. This function key deletes (or
zeroes) all data in the Accumulated Results portion of the screen and changes
the Status field for the method to “Setting Baseline.”
8 - 55
Activating or Deactivating an Assay

1. Select F5: PROCESS CTRL > F8: MORE OPTIONS > F2: RSLT MONITOR.
2. Select one of the assays that can be used with this feature by pressing its
method key or F1: NEXT METHOD.
3. Select F7: METHOD ON/OFF to turn the result monitor feature ON or
OFF.
The Result Monitoring in Effect field will indicate the on or off status.
5. Repeat Step 2 through Step 4 for each method to activate or deactivate.
Result Monitor Assays and Settings

Table 8-25: Result Monitor
Above Mean Factor Below Mean Factor Mean ±SD
Assay A B A B A B
ACP 1.25 1.25 0.80 0.80 0.00 0.00
ALDL 1.30 0.00 0.70 0.00 0.00 0.00
ALP 1.80 0.00 0.60 0.00 0.00 0.00
ALPI 1.80 0.00 0.60 0.00 0.00 0.00
ALT 1.30 0.00 0.75 0.00 0.00 0.00
ALTI 1.30 0.00 0.75 0.00 0.00 0.00
AMM 1.10 0.00 0.90 0.00 0.00 0.00
AMON 1.15 1.25 0.75 0.75 0.00 0.00
AST 1.20 0.00 0.75 0.00 0.00 0.00
BUN 1.08 0.00 0.92 0.00 0.00 0.00
CA 0.00 1.07 0.00 0.97 5.00 0.00
CCRP 1.25 1.10 0.65 0.75 0.00 0.00
CRE2 2.00 1.00 0.50 1.00 0.00 0.00
CREA 2.00 1.00 0.80 1.00 0.00 0.00
CSA 1.20 2.00 0.80 0.40 0.00 0.00
CSAE 1.20 1.10 0.90 0.80 0.00 0.00
ECO2 1.12 2.00 0.88 0.10 0.00 0.00
EZCR 1.20 0.00 0.80 0.00 0.00 0.00
FOLA 1.20 0.00 0.80 0.00 0.00 0.00
FPSA 1.2 0.00 0.80 0.00 0.00 0.00
FT3 1.15 0.00 0.85 0.00 0.00 0.00
FT4L 1.22 0.00 0.78 0.00 0.00 0.00
GGT 3.50 0.00 0.50 0.00 0.00 0.00
8 - 56
Above Mean Factor Below Mean Factor Mean ±SD
Assay A B A B A B
GLUC 1.20 1.02 0.85 0.96 0.00 0.00
HA1C 1.50 1.15 0.85 0.80 0.00 0.00
HB1C 1.50 1.15 0.85 0.80 0.00 0.00
HIL 2.50 0.00 0.60 0.00 0.00 0.00
LI 1.18 0.00 0.82 0.00 0.00 0.00
LIDO 1.50 0.00 0.50 0.00 0.00 0.00
LIPL 1.50 0.00 0.50 0.00 0.00 0.00
LNTP 1.20 0.00 0.80 0.00 0.00 0.00
MALB 4.00 0.00 0.50 0.00 0.00 0.00
MG 0.00 2.00 0.00 0.85 10.00 0.00
MPAT 1.5 1.5 0.5 0.5 0.00 0.00
MYO 1.20 0.00 0.80 0.00 0.00 0.00
NAPA 1.50 1.50 0.50 0.50 0.00 0.00
NTP 1.20 0.00 0.80 0.00 0.00 0.00
PALB 1.05 0.00 0.95 0.00 0.00 0.00
PROC 1.50 1.50 0.50 0.50 0.00 0.00
PTN 0.00 0.00 0.00 0.00 7.00 0.00
RCRP 1.20 1.20 0.80 0.80 0.00 0.00
SIRO 1.20 2.00 0.80 0.40 0.00 0.00
TAC 1.20 2.00 0.80 0.40 0.00 0.00
TACR 1.20 2.0 0.80 0.40 0.00 0.00
TGL 1.50 0.00 0.80 0.00 0.00 0.00
TNI 1.20 0.00 0.80 0.00 0.00 0.00
TP 0.00 0.00 0.00 0.00 10.00 0.00
TPSA 1.2 0.00 0.80 0.00 0.00 0.00
TSHL 1.20 0.00 0.80 0.00 0.00 0.00
VB12 1.20 0.00 0.80 0.00 0.00 0.00
8 - 57
Entering Sample ID Information

1. Select F6: SYSTEM CONFIG > F4: COMPUTER.
2. After making changes, press F7: STORE before exiting this screen.
The Sample ID/Computer Menu screen has four distinct sections:
• Segmented Wheel Setup
• Pediatric tube and SSC configuration
• Bar Code Configuration
• Test Scheduling and Reporting
The Segmented Wheel Setup section is used to indicate the information that
appears automatically on the Enter Sample Data screen.
The SSC sample container configuration section indicates the inside diameter
of the SSC container and, if necessary, designates those segments that are
used primarily with SSCs. The inside diameter must be entered before
segments can be assigned.
The system interprets any barcoded tube that it finds in an SSC designated
segment to be an SSC container. Whenever an SSC designated segment letter
is entered in the Position field on the Enter Sample Data screen, the Mode field
automatically changes to SSC.To use another container for that position,
change the mode field using F7: NEXT MODE.
The Bar Code Configuration section is used to read and interpret the barcode
system used by the laboratory and to set certain instrument actions when the
barcode is read. This section is also where you indicate whether to translate
certain LIS assay names to Dimension EXL system assay names. Turn these
functions on as needed for LIS compatibility.
The Test Scheduling and Reporting section is used to define information about
test priority scheduling and test reporting on the instrument.
Note: System configurations have already been set to meet
laboratory requirements during instrument installation. Do
not change any instrument option without laboratory
supervisor approval.
8 - 58
Table 8-26: Sample ID Information Fields
Field Explanation
Segmented Wheel Setup The Mode field on blank Enter Sample Data screens defaults to this.
Default Mode Use F8: NEXT SETTING to select other modes.
Default Fluid The Fluid field on blank Enter Sample Data screens defaults to this
entry. Use F8: NEXT SETTING to select other fluids.
Sample Edit Indicates the type of sample container that will be assigned to all
downloaded samples that are assigned segment positions by the
operator from the Sample Status screen. Use F8: NEXT SETTING to
select a sample container type.
If this field is set to No Default, sample positions cannot be assigned
for downloaded samples using the Sample Status screen.
Pediatric Tube and SSC Containers
Pediatric Tube Segments Indicates those segments that have been configured for Pediatric
tubes. Move the cursor to this field, select F5: ADD SEGS, enter the
segment letters and select ENTER, then select F7: STORE. The Mode
field on the Enter Sample Data screen defaults to PED Tube when
positions in these segments are entered.
PED Tube I.D. (mm) The inside diameter in millimeters of the PED tube used by the
laboratory.
SSC Indicates segments that have been configured for SSC use. Move the
cursor to this field, select F5: ADD SEGS, and use the keyboard to
enter the segment letters. Select ENTER, then F7: STORE. The Mode
field on the Enter Sample Data screen defaults to SSC when positions
in these segments are entered.
SSC I.D. (mm) The inside diameter in millimeters of the SSC. The inside diameter of
the SSC is 8 mm.
8 - 59
Field Explanation
Test Scheduling/Reporting Indicates how tests for a sample are processed.

Schedule Tests • “As Entered” processes assays in the order they were entered on
the Enter Sample Data screen.
• “Optimize Time to Result” processes assays by scheduling assays
requiring the longest processing time first. This produces
completed report slips faster.
• “Optimize Time/HM First” processes assays by scheduling HM
assays first, reducing the effect of the incubation periods of
these assays. When HM assays are part of the sample request,
this produces completed report slips faster.
STAT tests are always run first

Using either of the two "optimize" selections for the Schedule Test
field does not alter the scheduling of STAT tests. STAT tests are always
run first.
Priority Panel (schedule) Allows specific assays within samples to be given a higher scheduling
priority than the sample itself. This enables critical assays to be
processed in a STAT-like manner while the remainder of the assays for
the sample are processed with the priority given on the Enter Sample
Data screen (or downloaded through a host computer). When a
priority panel schedule is requested on a sample, the system raises the
priority of the assays in the designated panel one level above the
other assays requested on that sample. Enter the number of the panel
key defined for priority scheduled tests. Then select “STAT only” or “All
samples.”
Note: The priority scheduling option is not active for QC
samples or samples that include multiple test requests
of the same assay. All tests in the priority panel must
be ordered for scheduling to occur.
• If “STAT only” is selected, the priority panel is performed only on
samples that were entered as STAT.
• If “All samples” is selected, the priority panel is performed on all
samples, regardless of their priority.
Priority Panels:
The Priority Panel (schedule) and Priority Panel (report) fields do not
need to have the same information in them. Define different panels
for use in each of these fields.
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Field Explanation
Priority Panel (report) Enables the system to print a test report for a sample as soon as all the
assays in the panel are completed.
All assays in the priority panel must be ordered for the report to print.
Before enabling priority panel reporting, ensure that the host
computer is capable of receiving two reports for the same sample. If
the operator is not sure of this, check with the local host computer
consultant.
In addition, when the remaining assays of the sample are completed,
another report is prepared that includes all assays (including the
priority panel assays) requested on the sample. The priority of the
priority panel report printout is STAT, so that it can be distinguished
from the final sample report.
Note: The priority reporting option is not active for QC
samples or samples that include multiple test requests
of the same assay. Enter the number of the panel key
defined for priority report tests. Select “STAT only” or
“All samples” as discussed above for Priority Panel
(schedule).
Priority Panel (report) information on printouts and host

computer users:
The demographic data for both reports will match exactly. However,
the priority of the first report will always be STAT and its time/date will
be the time of completion of the priority panel, rather than the time of
entry. This permits the host system to distinguish the two reports.
Bar Code Configuration The test panel that is run on a barcoded sample if the system cannot
Default Test Panel find any patient data for the sample. Use the keyboard to enter a
panel number. If a default panel is not selected, enter a zero in this
field.
Processing Whole Blood Samples: Do not configure a default panel if
whole blood samples are processed. If a default panel is not
configured, deconfigure the option to avoid the potential for
inappropriately processing the default panel tests from a whole blood
sample.
Download Pretreats Indicates whether or not samples with pretreatment tests can be
downloaded from the laboratory LIS. Use F2: PRETREATS to select
YES or NO.
Bar Code Label Format The format of the barcode used by the laboratory. Use F8: NEXT
SETTING for other formats recognized by the system.
Label Length The field length of the barcodes used by the laboratory. This field can
be zero or a number from 3 to 12.
Leading Zeros Indicates whether or not the system recognizes zeros that precede a
barcode. If YES is selected, enter all the zeros that precede the
barcode when entering a Sample No. on the Enter Sample Data
screen. Use F3: ZEROS’S YES/NO to make a selection.
Translate TCO2 to ECO2 If turned ON, the system interprets an LIS request for assay TCO2 as a
request for tassayECO2.
Translate Low Volume If turned ON, the system interprets LIS requests for assay HCG, MMB
Test Method Names and TNI as requests for LHCG, LMMB, and LTNI when using the
reduced test Flex reagent cartridges for those assay.
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Using Test Counters

The Test Counters program keeps track of how many tests of each assay have
been run on the system. Only assays that consumed reagent are included in
this count. Display Method Test Counters screen by selecting:
F5: PROCESS CTRL > F8: MORE OPTIONS > F1: TEST COUNTS.
Table 8-27: Method Test Counters Fields
Fields Explanation
Total Results Includes all patient tests that produced a reportable result. Test results
with an “aborted test,” “no reagent,” or “not calibrated” processing
message are not counted because they did not consume reagent.
Conditional Results Includes all patient tests that produced a reportable result and included
an error code with the result. The Conditional Results count is included in
the Total Results count.
QC/Calib Includes all QC and Calibration tests that produced a printed result and
consumed reagent. The QC/Calib count is not included in the Total
Results count.
Last Saved The count that was in the Total Results column when F8: SAVE COUNTS
was last pressed.
Tests Since Last Save The difference between the Total Results column and the Last Saved
column.
Last Save Date The date and time when F8: SAVE COUNTS was last pressed.
Note: Total Results, Conditional Results, and QC/Calib fields can

each have a maximum count of 65,535 tests. When this
maximum is exceeded, the field automatically rolls over and
begins again from zero.
Selecting F8: SAVE COUNTS copies the Total Results count into the Last Saved
column and resets the Tests Since Last Save field to 0. The operator is
prompted with a message asking to continue. F8: SAVE COUNTS prevents loss
of the Total Results count before the automatic rollover occurs. Select
F5: PRINT to print these totals before saving counts. The Method Name, Total
Results, Conditional Results, QC/Calib, and Tests Since Last Save columns for all
assays appear on the printout.
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Storing Laboratory Data

The Store Laboratory Data feature contains various log files, QC records,
patient test results, and calibrations that are stored on the system hard drive
and can be transferred to a USB storage device. Based on the system volume,
and number of logs, establish a routine time interval for storing data using this
feature. Siemens recommends a monthly interval for Daily Maintenance, IMT
and Instrument Logs.
The data retrieved using this feature cannot be restored to the Dimension EXL
system and should not be considered an emergency backup for assay results
and QC records.
1. Connect the USB drive to the instrument.
2. Select F5: PROCESS CONTROL > F8: MORE OPTIONS >
F7: STORE LAB DATA.
3. Use the arrow keys (on the screen or on the keyboard) to advance the
cursor to one of the following fields:
• STORE QC RESULTS
• STROE TEST RESULTS
• STORE DAILY MAINTENANCE
• STORE PHOTO CALIBRATIONS
• STORE INSTRUMENT LOG
• STORE IMT LOGS
4. Select ENTER to toggle between OFF and ON.
Note: Stored Photo Calibrations includes LOCI calibrations.
5. Select F2: CHANGE DATE RANGE and record the new start date.
6. Select ENTER. Record the new end date and select ENTER.
7. The system will display a storing data and checking data integrity
message.
8. Select F1: STORE DATA to store the date to the USB drive. When finished,
disconnect the device and label properly.
Note: The USB drive is not intended to be used as a storage device,
but only as a transfer device for data.
How the Data is Stored

The data is stored in fields in a tab delimited text file. The extension ”.xls” lets
the operator open the file using the Microsoft® Excel spreadsheet program.
When the file is opened, the text appears with commas and tabs separating the
fields. Use the Excel text import wizard to format the fields into columns and
rows.
8 - 63
Figure 8-5: Quality Control Results (qcdat.xls) Example
Figure 8-6: Test Results (rsdat.xls) Example
8 - 64
Understanding the Data Fields

QC Results Fields in qcdat.xls File
These fields are from the example of field structure in QC data shown
previously. Headings are included in the data download. The actual headings
may differ slightly from what is shown here.
Table 8-28: Test Results Data File Structure (Excel Format)
Field Description
Method Abbreviation for the assay.
Shows one of these QC levels:
SerumQC1
SerumQC2
QC level
SerumQC3
UrineQC1
UrineQC2
Result Shows the QC test result.
Might show one of these indicators:

HI/LO
HI – result exceeds high QC value
LO – result is below low QC value
QC Lo The operator-entered low value for QC range.
QC Hi The operator-entered high value for QC range.
Error Error, if any, for the result.
Units Units used for the method.
Prod Name The name entered by the operator in the Patient Name field (on Enter Sample Data
screen) or downloaded from the LIS.
QC Lot # The lot number entered by the operator in the Sample No. field (on Enter Sample
Data screen) or downloaded from the LIS.
Flex Lot # Lot number of the Flex® reagent cartridge used in the QC run.
Note: LYTE will appear in this field for Na, K, and Cl.
Inst Type DIMEXL means Dimension® EXL ™ system.
Inst ID Unique identifier entered in the Instrument ID field in the Communication Set Up
screen.
Date The date the instrument reported the QC result.
Time The time the instrument reported the QC result.
8 - 65
Test Results Fields in rsdat.xls File

These fields are from the example of field structure in test results shown
previously. Headings are included in the data download. The actual headings
may differ slightly from what is shown here.
Table 8-29: Test Results Data File Structure (Excel Format)
Field Description
Patient Name Name of the patient entered in the ENTER DATA screen or downloaded from LIS.
Sample No. Sample number entered on the ENTER DATA screen or downloaded from LIS.
Method Abbreviation for the test assay.
Result Shows the patient test result.
Might show one of these indicators:
HI – result exceeds high reference value

HI/LO hp/lp
LO – result is below low reference value
hp - result exceeds high panic value
lp - result exceeds low panic value
R Lo The operator-entered low reference value for the assay.
R Hi The operator-entered high reference value for the assay.
Error Error, if any, for the result.
Units Units used for the assay.
Fluid Fluid type tested.
Lot number of the Flex® reagent cartridge used in the run.

Flex Lot #
Note: LYTE will appear in this field for Na, K, and Cl.
Inst Type DIMEXL means Dimension® EXL ™ System.
Inst ID Unique identifier entered in the Instrument ID field in the Communication Set Up
screen.
Date The date the system reported the test result.
Time The time the system reported the test result.
8 - 66
Daily Maintenance Fields in mtdat.xls File

The fields in mtdat.xls are displayed below. Column headings are included in
the data download. The actual headings may differ slightly from what is shown
here.
Table 8-30: Daily Maintenance Data File Structure (Excel Format)
Field Description
Daily Passed Shows Passed or Failed.
Daily Stored Date log was stored.
Initials Operator Initials.
Instr SN Instrument serial number.
Instr ID Instrument identification number.
Cuvt Temp Temperature Range - 36.8ºC-37.2º
HM Temp Temperature Range - 42º-44ºC (EXL HM 35º-41ºC )
Hyd Temp Temperature Range - 2ºC-8ºC
Reag Temp Temperature Range - 2º-8ºC
RMS Temp Temperature Range - 2ºC-8ºC
Temp Shows Passed or Failed.
Prime Date Date and time that the pump was primed.
Prime Cycles Number of pump prime cycles.
Sys Chk Date Date the system check was run.
Cuvettes Number of cuvettes left on the film.
Failed QC System check field specifications.
Photometer Shows Passed or Failed
Reag 1 Mean WHITE if within spec – RED if not
Reag 1 SD WHITE if within spec – RED if not
Reag 2 Mean WHITE if within spec – RED if not
Reag 2 SD WHITE if within spec – RED if not
Samp Mean WHITE if within spec – RED if not
Samp SD WHITE if within spec – RED if not
HM Wash HM WASH if HM is configured – otherwise IMT DIL

Mean/IMT Dil If HM:
Mean Mean: 10% value ±4 mAU
SD: ≤ 1.6
HM Wash If no HM:
SD/IMT Dil SD Dil 10% value ±2 mAU
SD ≤ 1.4
RMS Mean WHITE if within spec – RED if not
RMS SD WHITE if within spec – RED if not
8 - 67
Field Description
Cleaner Shows Passed or Failed.

Present if the HM is configured
Will pass if both Sample Probe Cleaner Passes and Reagent Probe Cleaner Pass
LOCI Shows Passed or Failed.

Will be present if the Loci is configured
Records highest value of 5 reads
All results: 0.001-0.144 counts
ABS/CHK Lot Contains the lot number of the CHK or ABS lex
Carton Value Contains the user entered bottle values of CHK or ABS
Empty Date Date and time that the cuvette waste was emptied.
Waste Emptied Shows Yes or No to indicate whether the cuvette waste was emptied or not.
8 - 68
Photometric Calibration Fields in cldat.xls

The fields in cldat.xls are displayed below. Column headings are included in
here.
Table 8-31: Photometric Calibration Data File Structure (Excel Format)
Field Description
Method Abbreviation for the assay.
Lot Reagent lot of method calibrated.
Date Date of calibration acceptance.
Time Time of calibration acceptance.
Cal Product Calibrator Product Name.
Cal Lot Calibrator product lot ID.
Calc Type Selection options include LINEAR, VERIFY, POWER, LOGIT, EXPLOG
Set Up By Technician who set up the calibration.
Accepted By Technician who accepted the calibration results.
Mode Calibration Mode: Operator, Instr - Default, or Instr -Customized
Cal ID Identification number associated with the calibration performed.
Instr SN Serial number of the Dimension System.
C0 Coefficent 0
C1 Coefficent 1
C2 Coefficent 2
C3 Coefficent 3
C4 Coefficent 4
E Coeff Extinction Coefficient if HA1C
esd Standard deviation of the Extinction coefficient.
Trip Level Options include: trip point, extended read vs, short read
Scaler A if scalers used (such as HA1C or PBNP)
Scaler B
Scaler C
Scaler D
Units Units used for the method.
BV1 Bottle Value - level 1
Mean 1 Mean of level 1 results
SD1 sd level 1 results
Lev1 Rep1 Result Concentration Repetition 1 - level 1
Lev1 Rep2 Result Concentration Repetition 2- level 1
8 - 69
Field Description
BV2 Bottle Value Level 2.
Mean 2 Mean of level 2 results.
SD SD of level 2 results.
Lev2 Rep1 Result Concentration Repetition 1 - level 2.
Lev2 Rep3 Result Concentration Repetition3 - level 2.
BV3 Bottle Value - level 3.
SD 3 SD of level 3 results.
8 - 70
Field Description
QC Level Level of QC fluid (1-5)
QC Result The QC result as displayed when the calibration was accepted.
QC Error # Instrument error when running QC.
Ref Range Lo Low en of the QC reference range for this fluid
Ref Range Hi High end of the QC reference range for this fluid level when the calibration was
accepted.
QC Out? Lo, Hi, or blank, depending on the result compared to the Ref Range.
Note: QC info is repeated 4 more times to accommodate 5 QC results.
HB BV L3 Bottle Value for HB Level 3.
HB SD L3 Standard Deviation for HB Level 3 Results.
HB3-1 Res Result 1 for HB Level 3.
HB3-2 Res REsult 2 for HB Level 3/
HB BV L4 Bottle Value for HB Level 4.
HB SD L4 Standard Deviation for HB Level 4 results.
m Slope of curve when the calibration was accepted.
b Intercept of when the calibration was accepted.
r Correlation coefficient when the calibration was accepted.
8 - 71
IMT Logs Fields in imtdat.xls File

The fields in imtdat.xls are displayed below. Column headings are included in
here.
Table 8-32: IMT Logs Data File Structure (Excel Format)
Field Description
Initials The initials of the person who stored the log. Will be XXX if stored automatically.
Date Stored Date and time the log was stored
Instr SN Instrument Serial Number
Instr ID Instrument Identification Number
Cal ID Identification number associated with the calibration performed.
Dil Chk Date Date the Dilution Check was performed.
Dil Chk Time Time the Dilution Check was performed.
Dil Chk Passed Will either be DIL CHK PASSED in GREEN or DIL CHK FAILED in RED or blank if no
DIL CHK was run
Corrected Shows either Yes or No
Bias White if below the limit, Red if above <.04
Uncorr Na Indicates if corrected or uncorrected values are being displayed.

Slope
Uncorr Na SD
Na Slope IMT Calibration Slope. Range equals 53 -65.
Na SD White if below the limit, Red if above <1.4
Na Bottle Bottle value is hard-coded - always 140.0
Uncorr K Slope Indicates if corrected or uncorrected values are being displayed.
Uncorr K SD
K Slope IMT Calibration Slope. Range equals 53 - 65
K SD White if below limit, Red if above <.01
K Bottle Bottle value hard coded - always 4.0
Cal Date Date Calibration was performed
Cal Time Time Calibration was performed
Cal Passed Will be either CALIBRATION PASSED in GREEN or CALIBRATION FAILED in RED
or blank if no CALIBRATION was run
Na Slope IMT Calibration Slope. Range equals 53-65
Na Slope Shows either Yes or No

Passed
K Slope 53-65
K Slope Passed Shows either Yes or No
CI Slope -55-40
8 - 72
Field Description
CI Slope Passed Shows either Yes or No
TC02 Slope 30-55
TC02 Slope Shows either Yes or No

Passed
IMT Air >=0.800
IMT Liquid <=0.600
Std A Lot ID Contains the lot ID for the IMT Consumables.
Std B Lot ID
Flush Lot ID
Salt Sol Lot ID
Diluent Lot ID
Sensor Lot ID
TC02 Lot ID
8 - 73
Instrument Log Fields in instrdat.xls File

The fields in instrdat.xls are displayed below. Column headings are included in
here.
Table 8-33: Instrument Log Data File Structure (Excel Format)
Field Description
Initials Operator Initials
Date Date the log was stored
Instr SN Instrument serial number
Instr ID Instrument identification number
Task Recorded task
Comment User Comments
Deleted Deleted log entry
Deleted Date Deleted log date
Deleted Initials Operator Initials
Deleted Log Comment

Comment
8 - 74
Selecting a Test Result Order

1. Select F6: SYSTEM CONFIG > F6: SELECT PRINTER >
F4: ORDER OF PRINT.
2. Select the first test to be printed on the test results printout.
3. When finished selecting the order of tests for the test result printout,
select F1: STORE CHANGES.
4. Use F8 to select how the tests will display on the test result printout.
Note: F8 toggles between Selected Ord and Sample Seq.
a. Select F8: SELECTED ORD to list the test results listed in the order
selected using this procedure (Selected Order);
b. Select F8: SAMPLE SEQ to list them in the order in which the tests
were actually processed (Sample Sequence).
A message displays indicating the order selected.
c. To delete a test, highlight the test in the box and select F2: DELETE
TEST. The next test selected displays wherever the cursor is
located.
Note: After selecting specific test order, do not use F4: DEFAULT
FILL to select the remaining tests. Using this option will
change your selection.
Note: To start over, press F3: CLEAR SCREEN. To print the selected
order, press F5: PRINT ORDER.
8 - 75
Test Key Assignments

Use the Assign Method Keys screen to customize the keys used to select test
methods.
The key assignment for each assay in the Dimension EXL system test menu is
preset in the software. However, these preset (or default) key assignments
may not be convenient to use in the laboratory because:
• The laboratory may not run all these assays.
• The operator may want to group the assays that are run regularly.
Test keys have been assigned numbers to use with the Assign Method Keys
screen. The illustration at the bottom of this page shows the number given to
each test key.
Note: The assigned keys for the assays have been set to laboratory
requirements during system installation. Do not change the
assigned key(s) for an assay without approval from a
laboratory supervisor.
Each test key has four possible positions for assigning assays. These are
referred to as positions 1 – 4. However, some positions on these test keys
cannot be customized.
Figure 8-7: Test Key
8 - 76
Figure 8-8: Test Keys
Table 8-34: Test Key Assignment
# Description
1 Keys 1-10: Four assays can be assigned to each of these keys.
2 Keys 11-15: Three assays can be assigned to each of these keys.

Position 1 cannot be reassigned.
3 Keys 16-25: Three assays can be assigned to each of these keys.

Position 4 cannot be used.
4 Keys 26-30: Three test methods can be assigned to each of these

keys. Position 1 cannot be reassigned.
Note: If fewer than 20 methods are run in the laboratory, the

operator can program an assay to position 1 on test keys
1-10 and 16-25. Tests can be selected without having to use
SHIFT, CTRL, or ALT keys as well.
Programming Test Keys

1. Select F5: PROCESS CTRL > F8: MORE OPTIONS > F8: METHOD KEYS.
Note: Use the function keys F1-F4 to select the view to use in
programming the assays.
a. F1: VIEW BY METHOD: Test key assignments are sorted
alphabetically by method. This is the view that always displays
when the Assign Method Keys screen are entered.
b. F2: VIEW BY GROUP: Test key assignments are sorted by the
additional keys (none, Shift, Ctrl, Alt) used with a key.
c. F3: VIEW BY KEY: Test key assignments are sorted by key number.
d. F4: UNASSIGNED: Displays the Unassigned Method Keys screen.
Use this screen to view what key or key combinations have not
been assigned to an assay.
2. Move the cursor to the assay. Use the current keys assigned to the assay
to locate the assay.
8 - 77
3. With the assay highlighted, select F5: ASSIGN KEY. Press the new keys to
assign to the assay. If the new key assignment causes an assay that will
be run in the laboratory to be unassigned, reassign it following steps 2
and 3.
4. Repeat Step 2 and Step 3 to program keys for other assays.
5. After changing the assays, select F8: STORE and enter a password.
Note: To return to the default key assignments in the software,
select F6: DEFAULT KEYS.
8 - 78
User-Defined Assays
This section contains all the information needed to understand and operate
the User-Defined Method feature on the Dimension EXL system. With this
feature operators can define their own assays using reagents that are not
purchased from Siemens. Operators can define these assays by choosing the
characteristics that fully describe an analysis. Up to ten assays can be defined
and stored.
Siemens provides validated instructions for using certain Emit assays. Contact
the Customer Care Center - Technical Solutions for the assay-specific
Application Sheet.
Assays defined with the User-Defined Methods feature are requested for
sample processing in the same way that Siemens assays are requested. They
can be processed along with Siemens assays in random, batch, or profile
modes.
Before using User-Defined Methods, operators should be familiar with the
basic operation of the Dimension EXL system because the procedures for
calibrating, performing quality control, and running patient samples are the
same as for Siemens assays.
To program and run a user-defined method, perform the following 12 steps in
sequence:
Table 8-35: Programming a User Defined Assay
Step Procedure to Follow
1. Enter the assay reaction parameters on the “Identifying the Method” on page 80
User-Defined Method screen. “Defining the Reagent and Sample Deliveries” on
page 81
“Defining the Photometry Reading Times” on
page 84
“Defining the Flex Cartridge Configuration” on
page 85
2. Program the user defined calculations on the “Defining the Calculation” on page 87
template and calculation screens.
3. Accept the template.
4. Accept the calculation.
5. Store the assay reaction parameters and “Storing a User-Defined Method” on page 89
calculation routine.
6. Print the assay reaction parameters and

calculation routine.
7. Enter the assay parameters under the System “Entering User-Defined Method Parameters” on
Configuration screen. page 90
8 - 79
Step Procedure to Follow
8. Fill a Flex reagent cartridge. “Filling a Flex Cartridge” on page 90
9. Load a Flex reagent cartridge. “Loading the Flex Cartridge” on page 91
10. Calibrate the assay. Calibration and QC of User-Defined Methods
11. Run QC samples.
12. Run patient samples. “Running a User-Defined Method” on page 92
Customer Responsibility
The Customer assumes all responsibility for the selection of the proper
reagents and entering the proper test parameters, use of the proper test
protocol, correctness of the test results, and any associated errors or
omissions.
Warranty
SIEMENS EXPRESSLY DISCLAIMS ALL WARRANTIES WITH RESPECT TO THIS
USER-DEFINED METHODS PRODUCT WHETHER EXPRESS OR IMPLIED,
INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE.
Since Siemens does not manufacture the reagents that our customers may use
in the user-defined Flex reagent cartridge, the warranty for the Dimension EXL
system does not extend to the performance of user-defined reagents
(including user-defined test results or standard Dimension EXL system test
results that are affected by user-defined testing), their effect on the system
operation and types and frequency of maintenance, or their effect on operator
safety.
Identifying the Method

1. Display the User-Defined Method screen by selecting:
F7:DIAGNOSTICS > F8: OPEN CHANNELS.
2. Select F5: NEXT CHANNEL to elect an unused channel.
Note: Fields that have blue characters cannot be edited. Only fields
with white characters can be changed. The F6: UNDO
CHANGES function key erases all changes on the screen that
were made since a method was last stored.
3. Enter up to three letters or numbers after the X in the Name field. Choose
a unique, original name for your method.
WARNING: Never assign the same name to more than one method.
This could result in erroneous or misleading test results.
4. Press F1: NEXT SELECT. to select a mode.
8 - 80
5. Press F1: NEXT SELECT to select a standard curve.

Table 8-36: Method Identification Fields
Field Information
Channel Ten channels (numbers 1–10) are available for user programming.
Name User-defined method names always start with an X. You can add
up to three additional alpha-numeric characters (XABC, XAB1, and
so on). Each user-defined method must have a different name.
Mode Absorbance or Turbidimetric.
Standard Curve Linear, Logit, or Verify.
Defining the Reagent and Sample Deliveries

Figure 8-9: User Defined Methods Screen
8 - 81
Reagent Delivery R1
1. Enter a delivery time (in seconds) for the reagent to be delivered. The
delivery time for R1 is preset and cannot be changed.
2. Select a component (Component 1) for the reagent delivery by pressing
F1: NEXT SELECT.
3. Enter the volume of Component 1 to be added to the cuvette.
4. If your method requires more than one component, repeat Step 2 and
Step 3 for Components 2 and 3 as necessary.
5. Enter the volume of chase to follow the reagent delivery.
6. Select a mix level for the reagent delivery by pressing F1: NEXT SELECT.
Note: All methods must specify a volume for at least one
component of R1.
Sample Delivery
1. Enter the volume of sample to be added to the cuvette.
Note: Sample volumes can range from 2 µL to 60 µL.
2. Enter the volume of chase to follow the sample delivery.
3. Select a mix level for the sample addition by pressing F1: NEXT SELECT.
8 - 82
Reagent Deliveries R2 and R3

Repeat Step 1 through Step 6 in “Reagent Delivery R1” on page 82 for a second
(R2) and third (R3) delivery as required by the method.
Note: If a volume is not specified for R2 or R3, no reagent will be
delivered. Also, R3 can only be added after R2. Multiple
deliveries occur when the reagent arm aspirates component
one first, followed by component two, and then if used,
component three. It will deliver these components to the
cuvette in the opposite order.
Reagent and Sample Delivery Fields

Table 8-37: Reagent Sample Delivery Fields and Descriptions
Field Explanation
Time R1 –57.6 seconds. Cannot be changed.

S1 00.0 seconds. Cannot be changed.
R2 Enter any time between 60.0 and 920 seconds.
R3 Must be at least 30 seconds later than R2 but not more than 920
seconds. In addition, do not specify a time between 257.3 and 389.3
seconds. Refer to the “Error Message List” at the end of this chapter for
details on timing restrictions.
The R2 and R3 times that actually display on the screen when Enter is
pressed may be a few seconds different from the times that were entered
because of the competitive scheduling of the system.
Component A component is a reagent that is stored in a well of the Flex cartridge. The
cartridge may contain up to five different components, but a component may
be stored in more than one well. it is possible to add as many as three
components in any single reagent delivery. Components are designated by the
letters A–E and correlate to well positions 1–5 in the Flex cartridge. Refer to
“Filling a Flex Cartridge” for details on specifying the location of components
within a cartridge. No order of use or delivery is implied by these letters.
Volume Enter volume in increments of whole µL. The total sample volume delivered
(including chase) must be less than 100 µL. Total volume, V, in the cuvette
(includes reagent, chase, and sample volumes) must be between 350 and
500 µL. Siemens recommends that at least 15 µL of chase per reagent delivery
is used to ensure that the reagents are adequately washed from the probe.
Chase Chase is a diluent (water) supplied by the instrument to flush the reagent lines,
sample probes, or systems after an addition. Enter any amount of chase
(water) that is consistent with the volume limitations described above and the
mix strength described below.
Mix Describes how vigorously to mix the reagent components (or sample) and
chase. GENTLE, MODERATE, STRONG, or NONE are the available choices. The
mix strength involves a combination of how long the solution is mixed, how
much energy is used, and how many pulses are applied. For gentle mixes, the
ultrasonics pulse for longer times at a lower energy level, while strong mixes
occur over a shorter time period with a higher energy level.
When selecting a mix level:
• be careful to prevent foaming.
• consider the chemical properties (such as viscosity) of the reagents and
sample.
The reagent chase volume must be at least 20 µL when a reagent mix is
requested. The sample chase volume must be at least 10 µL when a sample
mix is requested.
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Defining the Photometry Reading Times

Figure 8-10: User Defined Methods Screen
1. Enter a time (in seconds) for the first photometry reading (P1).
WARNING: Do not schedule a photometry reading within 10 seconds of a

reagent or sample delivery.
2. If the method requires additional photometry readings, repeat Step 1 for
P2, P3, and P4 as necessary.
Table 8-38: Allowable Photometry Read Times
Reading Time Range
P1 –30 to 675 seconds.
P2 0 (zero) to 675 seconds, but must be later than the first reading (P1).
P3 must be greater than P2, but less than 675 seconds.
P4 must be greater than P3, but less than 675 seconds.
Note: When defining a photometry read time, there must be at

least 350 µL in the cuvette when any photometric reading
occurs.
8 - 84
Defining the Flex Cartridge Configuration

Figure 8-11: User Defined Method Screen
1. Enter the component location for each well in the Flex cartridge by
putting the letter identification of the component under the appropriate
cartridge configuration number (well number 1, 2, 3, 4, 5, or 6) where it
is located in the Flex cartridge.
a. To do this, position the cursor in the parentheses under the well
number and press F1: NEXT SELECT until the proper letter appears.
2. Enter the number of tests for each well. The total number of tests must
be equal for each component (but not necessarily for each well) within a
Flex cartridge.
3. Enter the Well Life, which is the number of hours that each well will
remain stable after the well has been punctured by the reagent probe.
WARNING: The Well Life, On-Board Life, and Calibration fields should be
carefully determined prior to routine use of a user-defined
method.
4. Enter the On-Board Life, which is the number of hours that the Flex
cartridge remains stable after it has been placed in the instrument.
5. Enter how often this method must be calibrated (in hours).
WARNING: Use caution in determining the calibration life with respect to

variations in reagent preparation. Make sure that the
calibration will hold from cartridge to cartridge.
6. Do not press F4: STORE. The calculation to be used with this method
must be defined before storing. Continue with “Defining the Calculation.”
8 - 85
Flex Cartridge Configuration Fields

Table 8-39: Configuration Fields
Field Explanation
Component Reagent component designation and well location. Reagent components can be
located in one or more wells. Nominal Flex cartridge dead volume is 200 µL per well
when used with a user-defined method. The maximum volume of each well is 4.0
mL.
Relates to the number of test volumes in a cartridge well. This is the number of tests
available for all components in a cartridge. For example:
CARTRIDGE CONFIG 1 2 3 4 5 6
COMPONENT A B B C
NUMBER OF TESTS 20 10 10 20
Notice that, as required, components A, B, and C each have a total of 20 tests
Number available.
of Tests
Well Life The number of hours that a reagent (a component in a given well) remains stable
after the well has been punctured by the instrument. This can be up to 760 hours.
The default time is 72 hours.
On-Board The number of hours that reagents in a cartridge remain stable after the cartridge
Life has been placed on the instrument. This can be a maximum of 760 hours. The
default time is 720 hours (or 30 days).
The instrument maintains the cartridge at 2°–8°C as with all other reagents.
Calibration The maximum number of hours allowed between calibration. This can be a
maximum of 8760 hours (or 365 days). The default time is 2160 hours (or 90 days).
Calibration will remain valid within the same lot number of a method, as with
Siemens chemistries.
WARNING: Well Life, On-Board Life, and Calibration should be carefully determined prior
to routine use of a user-defined method. Use caution in determining the
calibration life with respect to variations in reagent preparation. Ensure that
the calibration will hold from cartridge to cartridge.
Note: Up to 99 tests can be assigned per well in the Flex cartridge.
8 - 86
Defining the Calculation

Press F7: CALCULATION to display the Multipoint MAU Calculation screen.
Using this screen, program the instrument to calculate a result for the
user-defined method that has been created.
Use the lines provide to write calculation programs or choose a standard
program (template) this is compatible with the data entered in defining the
laboratory method.
Writing A Calculation Program

1. Enter the programming commands on the lines provided using
acceptable programming terms described in “Programming Terms” later
in this chapter.
Note: Up to 25 lines of programming can be written.
2. Select F4: ACCEPT when the entries have been completed.
Note: The User-Defined Method: Multipoint MAU Calculation screen
displays with the calculation (in acceptable programming
terms).
4. Select Exit.
8 - 87
Using a Predefined Calculation Template

1. For a two-point calculation, select a calculation mode.
a. Move the cursor to the Mode field.
b. Select a calculation mode by pressing F1: NEXT SELECT.
2. Select a measuring filter by pressing F1: NEXT SELECT.
3. Select a blanking filter (if required) by pressing F1: NEXT SELECT.
4. For a three-point calculation, enter a depletion factor.
Note: This field displays only on a three-point calculation screen.
Move the cursor to the Depletion Factor field and enter a
number using the keypad keys.
5. For a single-point or two-point calculation, enter a dilution value.
a. Move the cursor to the Dilution field on the P1 line.
b. Enter a dilution value for P1 using the keypad keys.
6. Enter the IOD or FOD value in mAU using the keypad keys.
Note: Use F1: NEXT SELECT to choose the IOD or FOD message
indicator and select ENTER again.
7. Repeat steps 5 and 6 for P2 and P3 as required by the method.
Note: The User-Defined Method: Multipoint MAU Calculation screen
appears with the calculation in acceptable programming
terms.

10. Select Exit.
8 - 88
Table 8-40: Calculation Fields
Field Explanation
Mode Calculation mode: Rate or Endpoint.
Measuring Filter 293, 340, 383, 405, 452, 510, 540, 577, 600, 700, or NONE.
Blanking Filter 293, 340, 383, 405, 452, 510, 540, 577, 600, 700, or NONE.
Depletion Factor The system calculates a P1/P2 rate and a P2/P3 rate. If these rates differ from
each other by more than a given percentage (the depletion factor you
entered), an absorbance error message will appear on the printed test
results. A depletion factor must be entered on three-point calculation
templates.
Dilution Indicates the weighting factor or multiplier that compensates for the dilution
of the sample. This applies when sample or reagent is added between
photometry readings.
For example:
• R1 (at –60.0 seconds) involved the addition of 370 µL to the cuvette.
• P1 is at –30.0 seconds (the volume in the cuvette is 370 µL at this time).
• S1 (30 µL) the addition of 30 µL of sample occurred at 0.0 seconds.
• P2 is 65.0 seconds after the sample was added
(Total volume in the cuvette is now 370 + 30 = 400 µL.)
The dilution value is 400 µL divided by 370 µL (1.081).
The dilution value may be positive or negative. An undiluted sample would
have a dilution value of:
• 0 or 1.0 for a rate method
• 1.0 for an end point method
Initial Optical No limitations. Enter an IOD (in mAU) in the numerical field.
Density (IOD) Next to this field are parentheses where the operator must indicate if they
want an absorbance error message to be printed on the test results report.
Select BELOW if the operator wants the message to display when results fall
below the IOD that was entered. Select ABOVE if the operator wants the
message to appear when results fall above the IOD that was entered. Select
INACTIVE if the operator does not want a message to be printed.
Final Optical No limitations. Enter an FOD (in mAU) in the numerical field.
Density (FOD) Next to this field are parentheses where to indicate if the operator wants an
absorbance error message to be printed on the test results report. Select
BELOW if the operator wants the message to display when results fall below
the FOD that was entered. Select ABOVE if the operator wants the message
to display when results fall above the FOD that was entered. Select INACTIVE
if the operator does not want a message to be printed.
Storing a User-Defined Method

1. At the end of programming, go back to the first User-Defined Method
screen and press F4: STORE to store the method reaction parameters.
Note: The system performs checks on the data that was entered. If
there is an error, a message displays on the screen. The data
will not be stored until the error is corrected and F4: STORE is
pressed.
Note: If all data entries are acceptable, the message “Method
Parameters have been stored” displays.
2. Press F8: PRINT.
8 - 89
Entering User-Defined Method Parameters

Method parameters must be entered for all user-defined methods before a
user-defined Flex cartridge is inserted into the system or a sample is run.
These parameters are different from the ones entered on the User-Defined
Method screen. These include the linear range, the reference range,
auto-dilution volume, C0, C1, etc. They tell the system general information
included on the results report. Enter information in the following areas for the
method to operate: reference interval, assay range, calculation type, C terms,
and lot number. The procedure for entering method parameters for
user-defined methods is the same as for Siemens methods. See “Entering
Method Parameters” on page 33 of this chapter.
Filling a Flex Cartridge

WARNING: Use caution when considering reagents such as strong
alkaline and acid solutions, organic solvents, viscous liquids,
heavy metals, or metal chelating agents. They may have
adverse effects on the system.
To fill a Flex cartridge, puncture the clear film that covers the individual wells
as needed. Fill the wells with the appropriate volume of reagent, as defined in
the Cartridge Configuration section of the User-Defined Method screen.
Note: The clear film should not be removed and puncture holes
should not be resealed.
Use the six-well Flex cartridge (Order Number DF99) as the reagent vessel with
User-Defined Methods. This is an empty Flex cartridge to which the operator
adds their own reagents. The empty Flex cartridge can be stored at room
temperature until the expiration date.
CAUTION: Use only liquid reagents. No onboard preparation is permitted.

Figure 8-12: Flex® Cartridge
CAUTION: Do not try to use an eight-well Flex cartridge because this will
damage the reagent probe.
8 - 90
Loading the Flex Cartridge

Method parameters must already be entered before inserting a user-defined
Flex cartridge into the instrument.
1. Select F4: SYSTEM PREP > F1: INVENTORY > F4: ADD REAGENT.
Note: This is the same process as “Manually entering a Reagent
Cartridge Barcode” on page 15 of Chapter 2: System
Operation.
2. Place the Flex cartridge in the automatic loader.
3. When instructed to do so, use the keyboard to enter the Flex cartridge
information.
Table 8-41: Field Cartridge Information
Field Information
Method Enter the same name that was already assigned to this method on the
Method Parameters screen
Lot number A unique and valid six-character designation.
Sequence number A unique, five-digit number. This number must be different for all
reagent cartridges for this method.
4. Press F1: ACCEPT.

Note: A valid lot number consists of six digits, such as FM1082 in
the following sequence: Any two letters (FM); the last digit of
the year the Flex cartridge will expire (4 for 2014); the month
and day the reagent cartridge will expire, expressed as a
Julian date (March 23 = 082).
8 - 91
Calibration and QC of User-Defined Methods

Calibration of user-defined methods is the same as for Siemens methods.
However, the operator is responsible for determining how often calibration
must be performed. Refer to “Calibrating/Verification Overview” in Chapter 6
for further information on calibration and verification.
It is also up to the operator to determine which quality control products to use
and how often to use them. Ordering a quality control test for a user-defined
method is the same as for any Siemens method.
Running a User-Defined Method

CAUTION: Method parameters must already be entered before attempting
to run a sample with a user-defined method.
User-defined methods can be requested and processed along with Siemens
methods in random, batch, or profile modes.
To request a user-defined method, refer to Table 8-42. These keystrokes may
be different on the instrument if these methods were programmed to other
keys. To program different tests to the test keys, see “Programming Test Keys”
Table 8-42: Default User-Defined Method Keystrokes
To Request This
User-Defined Test Press this Key Combination
Method
X01 Control/GGT
X02 Control/GLUC
X03 Control/LDI
X04 Control/LYTES
X05 Control/NA/K
X06 Control/PHOS
X07 Control/TBI
X08 Control/TP
X09 Control/TGL
X10 Control/URCA
WARNING: Use caution when considering reagents such as strong

alkaline and acid solutions, organic solvents, viscous liquids,
heavy metals, or metal chelating agents. They may have
adverse effects on the system.
8 - 92
Reviewing a Method’s Kinetics

The Method Kinetics program allows the operator to observe and review a
method’s kinetics while it is running. Display the Method Kinetics screen by
pressing F7: DIAGNOSTICS > F7: KINETICS.
Method Kinetics Screen

The data fields at the top of the screen may be blank or they may contain
default data until a method is selected and F1: START ASSAY is pressed.
At the bottom of this screen is a graph that displays absorbance vs. time for the
user-defined method that were chosen to review. The x-axis represents time
(seconds) and the y-axis represents absorbance (mAU).
8 - 93
Method Kinetics Screen Fields

Table 8-43: Method Kinetics Screen Fields
Field Explanation
Method () The method name displays in this field when the method is selected. The
description “6 well” for the Flex cartridge is always displayed within the
parentheses.
Filters The 3-digit fields to describe the wavelengths to be graphed on the kinetics
screen.
1st field Shows which single wavelength to display on the graph. Press F6: FILTER
DISPLAY to change this field. To display more than one wavelength, choose
“bic” for bichromatic, or “---” to display all ten wavelengths.
2nd and 3rd fields Initially show the Measuring Filter and Blanking Filter wavelengths you
chose when programming the method. These wavelengths appear on the
graph if you chose “bic” for the 1st field. To change the first wavelength,
press F3: 1st BICHROME; to change the second, press F4: 2nd BICHROME.
If a single wavelength or all ten wavelengths are chosen, these last two
fields display the wavelengths programmed into the method. Changing
them does not affect what is displayed on the graph. If turbidimetric mode
is chosen when identifying the method, an asterisk (*) follows the Filters
field until the kinetics reaction has started. After the kinetics reaction has
started, the running time of the assay follows the Filters field regardless of
which mode is selected.
Scale mAU Describes the absorbance scale (in mAU) of the y-axis.
Time Describes the time scale (in seconds) of the x-axis.
Filename A file name displays in the Filename field when the data is archived. For
user-defined methods, the file name is always “kinetics.ar” and the system
saves the most recent study. Press F5: ARCHIVE DATA to archive the data.
Marker Up to two markers (blue vertical lines, x and o) can be displayed on the
graph.These markers can also be moved during the reaction but only to the
point where the reaction has progressed. Move the cursor to the Marker
field and select Enter to select the marker(s) that you to be viewed or move.
Use the arrow keys to move the marker(s) that were selected. Markers can
continue to be moved throughout the reaction process.
Other fields related to the x and o markers
dmA(x-o) The change (delta) in mAU between the x and o markers.
dT The change (delta) in time between the x and o markers.
mA, bic dmA mAU with respect to a bichromatic reaction, specifically the change (delta)
in mAU, x and o.
mA/min With respect to bichromatic reactions, this is the change (delta) in mAU per
minute.
8 - 94
Note: Changing filters using F3, F4, and F6 does not affect the
programmed method. They only change the wavelengths
displayed on the Method Kinetics screen being viewed, but
do not change what has been programmed in the method
itself.
Note: If using an external printer, all the photometrics data from
the kinetics assay that was run will be printed when
F5: ARCHIVE DATA is pressed.
8 - 95
Table 8-44: Cartridge Configuration Table
Cartridge Configuration:
Well #
Component
Volume (max 4.0 mL)
# tests/well
8 - 96
Table 8-45: Reaction Kinetics Table
Reaction Kinetics:
Reaction Timeline
Event
Time
Volume: Component 1
Component 2
Component 3
Total Volume in Cuvette
(Reminder: Volume in the cuvette must be > 350 µL whenever a photometer reading is programmed.)
8 - 97
Using Method Kinetics

1. Display the Method Kinetics screen by pressing F7: DIAGNOSTICS >
F7: KINETICS.
2. Load the sample in segment #1, position #1.
WARNING: Do not load samples into the sample area if:

• The segment's status box is red
• The system is initializing or processing
• The moving wheel light is lit
• The message “Moving Wheel...” is in the photometric
sampler status box
Do not place hands in the sample wheel area while the
instrument is initializing or processing as it could cause injury
or damage to the instrument.
3. Select a user-defined method. Event markers (R1, R2, S, etc.) display on
the x-axis at the times programmed.
4. Press F1: START ASSAY.
5. When the message Insert 6-well Flex. (**Investigative Use Only**)
appears, place the Flex cartridge to be used with this method in the
automatic loader.
CAUTION: Do not load the Flex cartridge into the automatic loader until this
prompt displays.
6. Observe the messages as the method reaction progresses.
After the time clock has started, you can stop the reaction at any time by
pressing F1: STOP ASSAY.
You can also change the filter display during the reaction and the graph
automatically updates to the new wavelengths.
7. After the reaction is complete, you can:
a. Choose a print option:
1) Press CRTL+P key combination for a printout of the screen.
2) Press F8: PRINT (with 1 or 2 wavelengths displayed) for a
graph of the active wavelength.
3) Press F8: PRINT (with all wavelengths displayed) for a
complete data dump of all readings for all wavelengths.
4) Make note of any data that you want to edit into the
User-Defined Methods screen for that method.
8. Select EXIT to leave the Method Kinetics screen.
Note: The system displays a message to remove the
investigative-use Flex cartridge.
9. Remove and discard the investigative-use Flex cartridge.
8 - 98
WARNING: Always prepare a new Flex cartridge for running routine

samples because the cartridge used for kinetics is not tracked
in inventory.
Programming Terms
The Dimension EXL system user-defined software application provides a
versatile method of specifying how raw photometric data is transformed prior
to conversion to analyte concentration through the method’s standard curve.
Examples of simple transformations would include bichromatic endpoints and
two-point rates. More complex transformations include polychromatic sums,
volume-corrected blanking for endpoint reactions, and checking for substrate
depletion through comparison of early/late reaction rates.
The capability provided by the transformation program is similar to the
functionality provided by a four-function calculator. The four common
arithmetic functions—add, subtract, divide, multiply—are provided, as well as
parentheses. Twenty-six temporary memory registers are provided for the
storage of intermediate results. Functions are available for calculating
monochromatic and bichromatic rates and endpoints from the raw
photometric data arrays.
Programming Structure
All programs must have a left brace ({) as the first character and a right brace
(}) as the last. At least one RETURN statement is required to forward
meaningful results from the calculation.
Enclosed within the braces are program statements. Statements are used to
assign intermediate results to registers, test logical conditions, set error codes,
and return transformed mAU to the system.
Implementation
The MAU Calculation screen provides the 25 lines in which to enter a
transformation program. The input is in the form of a simple programming
language, which provides functions to retrieve raw data from the photometric
data arrays, algebraic statements to transform that data mathematically, and
test statements (if/else) that can be used to set error flags. In addition, there
are 26 registers labeled A–Z that can be used for temporary storage of
intermediate results. The final result is RETURNED for input into the standard
curve transformation.
8 - 99
For instance, the program

1. {
2. A = BICH(P1,340NM,383NM);
3. RETURN A;
4. }
calculates a bichromatic 340–383 nm endpoint. The braces { } surrounding the
calculation (lines 1 and 4) demarcate the beginning and end of the calculation,
and must be included in all programs. Any text outside of these brackets is
ignored. The BICH function on line 2 calculates the bichromatic difference
observed for photometric reading P1. The value is placed in the temporary
register A, whose value is RETURNED to the system by statement 3.
Similarly, the program
1. {
2. A = RATE(P1,P2,340NM,383NM);
3. RETURN A;
4. }
calculates a bichromatic 340–383 nm rate. The RATE function on line 2
calculates the rate of reaction (in mAU/min) observed between photometric
readings P1 and P2. The value is placed in the temporary register A, whose
value is RETURNED to the system by statement 3.
For these simple examples, there is no need to place the intermediate result in
register A. The endpoint program could have been written simply as:
• {RETURN BICH(P1,340NM,383NM);}
To improve readability, statements can be broken across lines, and spaces can
be inserted:
1. {
2. RETURN
3. BICH(P1, 340NM, 383NM);
4. }
Statements
Statements can take any of the following forms:
• Register = numerical expression;
• SET errorcode ERROR;
• RETURN numerical expression;
• { statement1; statement2; ...; statement N; }
• IF (logical expression) statement
• IF (logical expression) statement ELSE statement
Examples of these types of statements appear as follows:
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register = numerical expression

This statement is used to assign an intermediate result to a register. Register
can be any of the 26 general registers A,B,C...X,Y,Z. Numerical expressions are
described later.
SET errorcode ERROR
This statement is used to set error codes on the report slip. Accepted values for
errorcode are ABSORBANCE, ARITHMETIC, MEASUREMENT, and REACTION.
For simplicity, the last error set is the one that is forwarded for publication.
Therefore, the programmer can establish error precedence. If an arithmetic
error is detected by the system, the system will automatically forward an
ARITHMETIC error with no numerical result.
RETURN numerical expression
This statement is used to forward a transformed mAU to the system. The
numerical expression is frequently a register, but may be any numerical
expression (refer to “Expressions” later in this chapter). Once a RETURN
statement is encountered in a program, no further statements are executed.
{ statement1; statement2; ...; statement N; }
The statement syntax is a compound statement, used to group several
statements. This syntax is most useful when multiple simple statements must
be executed as a group, as within the context of an IF or IF/ELSE statement.
IF (logical expression) statement
This statement is used to test logical conditions and execute a statement if the
logical condition is TRUE. IF statements are most often used to conditionally
execute SET errorcode ERROR statements, as in this substrate depletion
scenario:
1. {
2. A = RATE(P1,P2,340NM,383NM);
3. B = RATE(P2,P3,340NM,383NM);
4. IF (B < 0.80 * A) {
5. SET ABSORBANCE ERROR;
6. RETURN A;
7. } ELSE {
8. RETURN B;
9. }
10. }
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The first statement calculates the rate of reaction between readings P1 and P2,
and assigns it to register A. The second statement calculates the rate between
readings P2 and P3, and assigns it to register B. The IF statement will flag an
absorbance error (if the later rate is less than 80% of the earlier rate) and
RETURN the value of the early rate as the transformed mAU value. Otherwise,
no error is set, and the later rate in register B is returned.
Note that the TRUE clause of the IF/ELSE statement contains a compound
statement, which is used to group the SET and RETURN statements into a
single clause.
IF (logical expression) statement ELSE statement
This statement is similar to the IF statement. However, the ELSE statement is
executed when the logical expression is FALSE.
Expressions
Two classes of expressions are possible, depending on the kind of value
produced by the expression. The first class, referred to as numerical
expressions, produce numerical results that can be assigned to registers or
returned as values. The other class, called logical expressions, produce logical
results from Boolean operations. Logical expressions are used exclusively
within IF statements. The output of a logical expression cannot be used to
assign values to registers, nor can it be returned.
Numerical Expressions
Numerical expressions allow the user to combine values from function calls,
registers, and constants together using the arithmetic operators *, /, +, and – .
The precedence of these operators corresponds to common usage, where *
and / have the same precedence, and are evaluated as encountered in
left-to-right order; + and – have lower precedence than * and /, and are also
evaluated in left-to-right order. Operator precedence and evaluation order can
be modified through use of parentheses, which can be nested. The following
are valid expressions:
a. (a) A + (B + C) * D
b. (b) (A + B) * 0.5
c. (c) MAU(P1,340NM) – MAU(P1,383NM)
d. (d) A/B * RATE(P1,P2,340NM,510NM)
The resulting value from a numerical expression is usually assigned
to a register or returned:
e. (e) RETURN A + (B + C) * D;
f. (f) C = (A + B) * 0.5;
g. (g) Z = MAU(P1,340NM) – MAU(P1,383NM);
h. (h) RETURN A/B
* RATE(P1,P2,340NM,510NM);
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Note: Note that assignment and return statements are always

terminated by a semicolon. Also, expressions may be broken
into multiple lines to enhance readability as in (h) above.
In addition to assignment (=) and being RETURNED, the value of a numerical
expression may be used in a comparison operation within a logical expression
(refer to Logical Expressions discussion below).
Logical Expressions
Logical expressions are used within IF statements, which allow a statement or
group of statements to be executed when the logical expression evaluates to
TRUE.
Logical expressions are composed of comparison operations, combined
together using the AND and OR operators. (No NOT operator is provided, since
the comparison operations can be structured to effect the NOT operator).
Comparison operators include > (greater than) , < (less than), and two equal
signs == (equal to). Numerical expressions serve as operands for these
comparison operators. (Note that testing for equality is strongly discouraged,
since floating point calculations often experience rounding errors, which cause
equality comparisons to fail.)
Several AND and OR operators may appear within a logical expression. The
AND operator has higher precedence than the OR operator. The default
precedence and order of evaluation may be altered using parentheses. For
example:
• A>B
TRUE if register A is greater than register B.
• A > B AND C/D < 0.5
TRUE if register A exceeds register B, and C/D is less than 0.5.
• A > 100.0 OR B < 100.0 AND A/B > 0.50
TRUE if either of the two the conditions listed below tests TRUE:
1) register A exceeds 100.0.
2) register B is less than 100.0 and the ratio of register A to
register B exceeds 0.50.
Note: In example (c) the AND operator has precedence over the OR
operator; the AND operation is tested first, despite the fact
that it is the rightmost operator.
The operators AND and OR are lower in precedence than the arithmetic *, /, –,
and + operators. Consequently, there is no need to use parentheses to
surround numerical expressions in comparison operations.
8 - 103
Functions
There are several functions that are useful for extracting data from the raw
photometer data arrays. In all cases, arguments must be supplied to the
function that tells the system which photometric reading(s) and which
wavelength(s) are of interest. Photometric readings are specified as P1, P2, P3,
or P4 and correspond to the readings specified on the User-Defined Method
screen. Wavelengths are specified as 293NM, 340NM, 383NM, 405NM,
452NM, 510NM, 540NM, 577NM, 600NM, or 700NM. In addition, the value
---NM is accepted as a null wavelength specifier, which indicates that no
wavelength is desired.
Table 8-46: Available Functions and Their meanings
The available functions are:
MAU(Px, yyyNM) Returns the milliabsorbance value of wavelength yyyNM of

photometric reading Px.
BICH(Px, yyyNM, zzzNM) Returns the bichromatic difference in mAU of wavelength

yyyNM minus mAU wavelength zzzNM of photometric reading
Px.
RATE(Pw, Px, yyyNM, zzzNM) Returns the rate of reaction (mAU/min) between photometric
readings Pw and Px for the bichromatic difference of
wavelength yyyNM minus wavelength zzzNM.
Note that there is no explicit monochromatic rate function. In order to obtain a monochromatic rate,
the null wavelength specifier should be used:
RATE(Pw, Px, yyyNM, ---NM) Returns the monochromatic rate of reaction (mAU/min)
between photometric readings Pw and Px for the wavelength
yyyNM.
In addition to these data abstraction functions, an absolute value function is provided:
ABS (numerical expression) Returns the absolute value of the expression.
Error Message List

Note: Error messages are in bold and arranged in alphabetical
order. Their explanation (where included) is listed beneath.
A reagent delivery component or component volume is inconsistently
specified.
Each reagent delivery component must specify both an identifier (A, B, C, D, E)
and a nonzero volume. If these two conditions are not met, this message will
be displayed.
A time must be provided for the second reagent delivery.
This message occurs when the user neglects to enter a time for the R2 delivery.
A time must be provided for the third reagent delivery.
This message occurs when the user neglects to enter a time for the R3 delivery.
A total volume of 0 for the first reagent delivery is not permitted.
8 - 104
All assays must provide some volume during the first reagent delivery. Either
chase or reagent component(s) (or both) need to be specified for the R1
delivery.
A well component or aliquot needs to be provided.
If a well has nonzero aliquots but no identifier (A, B, C, D, E), this message will
be displayed. Similarly, an identifier with zero aliquots will generate this
message.
Every reagent component delivered must appear in at least one well.
If a component identifier (A, B, C, D, E) appears in a reagent delivery (R1, R2,
or R3), it must also appear in the reagent cartridge.
Photometries must be time-ordered, and at least 15 seconds apart.
Photometry must occur within the interval <–30...950> seconds.
Please UNDO CHANGES before attempting to advance channel.
This message displays when the user attempts to move to another channel
without storing changes on the current channel.
Syntax errors have been found on this line.
If a syntax error is detected, the system attempts to move the cursor to the line
in which the error was detected. Note that occasionally the syntax error may
be on a preceding line; the program parser was unable to conclude that there
was an error until it had “looked ahead” a bit to see what came later!
The calculation is either too complex or not correctly terminated.
If a trailing right brace is missing, or a compound statement was not correctly
closed, the system will be unable to detect the end of the program. Check that
the braces balance, i.e., that total number of left braces ({) equals the number
of right braces (}).
This error may also occur if an expression is found that contains deeply nested
pairs of parentheses [e.g., ((((1 + (2/3) / (3 * (A) + (((0.1))))))))]. If such an
expression exists, simplify it using register assignments.
The second reagent delivery must fall within the interval <60...920
seconds>.
In order to easily access the reagent delivery stations, reagent deliveries should
fall within this time interval. Deliveries are excluded between 257.3 and 389.3
seconds, since the cuvette cannot be accessed during this time. However,
there is opportunity for access during the interval 389.3 to 461.3 seconds,
which has an undesirable side effect of requiring the system to index cuvettes
until the cuvette enters an accessible zone. The system will accept a reagent
delivery during this interval, although it may sometimes result in wasted
cuvettes.
The sum of all volumes exceeds the maximum cuvette capacity (500 µl).
The cuvette can only hold 500 µL of volume. When this message displays, try
scaling all volumes to bring the total volume under 500 µL.
8 - 105
WARNING: No error is generated if the total volume is unrealistically low.

350 µL of volume is required to fill the optical area of the
cuvette. Therefore, it is particularly important that there be at
least 350 µL of volume present in the cuvette before a
photometric read is attempted.
The sum of the reagent component volumes plus chase cannot exceed
490 µl.
The reagent syringe can accommodate only 500 µL of total volume; 10 µL is
reserved for air separators. Either the reagent volume(s) or chase volume must
be reduced.
The sum of the sample volume plus sample chase cannot exceed 100 µl.
The sample syringe can accommodate only 100 µL of total volume. Reduce
either the sample or chase volume.
The system must be in STANDBY before attempting to STORE any changes.
Upon entry, or in response to pressing F4: STORE, the system checks to be sure
no assays are in process. Since storing data may affect assays that are in
process, the system will not store new parameters until the system returns to
Standby.
The third reagent delivery must fall within the interval <60...920
seconds>.
In order to easily access the reagent delivery stations, reagent deliveries should
fall within this time interval. Deliveries are excluded between 257.3 and 389.3
seconds, since the cuvette cannot be accessed during this time. However,
there is opportunity for access during the interval 389.3 to 461.3 seconds,
which has an undesirable side effect of requiring the system to index cuvettes
until the cuvette enters an accessible zone. The system will accept a reagent
delivery during this interval, although it may sometimes result in wasted
cuvettes.
The third reagent delivery must follow the second by at least 30 seconds.
The reagent delivery system requires time to complete each delivery cycle. R2
and R3 reagent deliveries are precluded from being within 30 seconds of each
other.
The well aliquots total for each component must be the same (and
non-zero).
The number of aliquots for each reagent component identified must be the
same. It is not necessary that the number of aliquots for all components A, B,...
be the same in each well. However, the total of all the A component aliquots in
all A wells must equal the number of B aliquots in all B wells.
There are no current changes to undo. Do you wish to NULL the entire
record?
This message displays when F6: UNDO CHANGES is pressed and there are no
current changes made to the channel. If the user enters Y, the channel is
initialized. Otherwise, the operation is aborted.
8 - 106
This password is not correct. You will not be permitted to STORE any
changes.
The user is prompted for the system password upon entry into User-Defined
Methods. If no password or an incorrect password is entered, this message is
presented to the user. If an invalid password is entered, anþattempt to store
using F4: STORE will again result in a prompt for password, at which time
correct entry of the system password will permit data to be stored.
Undo current changes to this channel?
This message appears when F6: UNDO CHANGES is pressed. If the user enters
N, the undo operation is aborted.
When reagent mix is requested, the reagent chase volume must be at
least 20 µL.
The ultrasonic system requires some chase to be expelled as ultrasonic mix
begins. When reagent mix is requested, there must be at least 20 µL of chase
available.
When sample mix is requested, the sample chase volume must be at least
10 µL.
The ultrasonic system requires some chase to be expelled as the ultrasonic mix
begins. There must be at least 10 µL of chase available when a sample mix is
requested.
8 - 107
Figure 8-13: User-Defined MEthods Worksheet
8 - 108
Dimension EXL with LM/EXL 200 System Operator’s Guide Appendix
Appendix
9-1
Appendix Dimension EXL with LM/EXL 200 System Operator’s Guide
Safety
General Safety
To operate the system, the operator must be proficient in its operation and
maintenance procedures.
To ensure safety, follow basic precautions.
• Always wear gloves when operating the Dimension EXL system.
• Observe all warnings and cautions in the manual.
• Remove safety guards only if specifically instructed in the procedures.
Replace all guards after completing the procedures.
• Stow cables and tubing properly to eliminate tripping hazards.
• Use only specified cleaners on the Dimension EXL system. Using other than
the specified cleaner will cause imprecision in some methods.
• Review the Flex reagent cartridge Instructions for Use (IFU) for specific
chemicals and safety information about the reagents in each method
cartridge.
Note: If the equipment is used in a manner not specified by the
manufacturer, the protection provided by the equipment may
be impaired.
Biohazard and Probe Safety

Follow standard laboratory practice for protection from biohazards when
performing maintenance and troubleshooting.
• Observe all warnings and cautions stated in the manual.
• Always perform every step in a procedure in sequence as written, including
pressing PAUSE or raising instrument lids to prevent probes from moving
while performing a procedure.
• All materials that come in contact with patient samples should be
considered potential biohazards and treated according to local biohazard
handling and disposal procedures.
Instrument Removal
Please contact a Siemens Healthcare Diagnostics service representative for any
system removal for repair or disposal.
9-2
Safety Notes
Warnings and cautions are included throughout this guide to emphasize
important and critical instructions.
WARNING: An operating procedure, step, or practice that, if not followed

correctly, could result in personal injury, affect the operator’s
health, contaminate the environment, or cause erroneous
and misleading results.
CAUTION: An operating procedure, step, or practice that, if not observed

strictly, could result in damage to equipment.
Note: Additional information is included to clarify a particular step,
procedure or paragraph.
9-3
Safety Labels
Safety labels are affixed to the instrument to alert operators to safety
considerations.
Table 9-1: Safety Labels and Their Description
Label Description
Attention Indicates specific safety instructions involving the marked

areas of the instrument. When used with another symbol, the
attention label points out another warning label defined in
this guide. Operators should understand that warning before
accessing the labeled area of the instrument.
Potential Biohazard Indicates an area of the instrument that could have been in
contact with biohazardous materials. Do not handle the
contents or touch the area unless properly protected. Refer to
applicable laboratory procedures and to the guidelines set
forth by the Department of Labor (OSHA) 29CFR Part
1910.1030, Occupational Exposure to Bloodborne Pathogens:
Final Rule.
Pinch Hazard Indicates an area of the instrument where the operator can be
exposed to moving parts. Be careful around these parts when
performing diagnostic and maintenance operations with
safety shield removal.
Puncture Hazard Indicates an area of the instrument where the operator can be
exposed to a sharp tip that could puncture the skin. In
particular do not extend fingers under the guard over the
sample area during operation.
Burn Hazard Indicates a heated area of the instrument that can burn an
operator. Be sure to power off the instrument and let these
areas cool before touching them or performing diagnostic and
maintenance operations around them.
Electrostatic Discharge Indicates potential damage to electronic boards from

electrostatic discharge. Firmly attach the grounding wrist strap
to the wrist prior to handling any electronic board.
9-4
Label Description
Protective Earth Terminal Indicates the terminal that connects the power supply line
external earth (ground) to the instrument.
Indicates the terminal that connects the power supply line

external earth (ground) to secondary instrument systems.
Open Lid Indicates an area of the instrument where the operator can be
exposed to a closing lid. Be careful around these parts when
performing diagnostic and maintenance operations.
Crush Hazard Indicates an area of the instrument where the operator can be
exposed to moving parts. Be careful around these parts when
performing diagnostic and maintenance operations.
Link Symbol Indicates that the instrument is being operated from a remote
location.
Laser Label Indicates an area of the instrument where an operator can be

exposed to direct laser emissions. Do not look directly into the
aperture of the emitted laser beam. The maximum radiant
power at the aperture of the laser barcode reader is 1.0
milliwatt.
Printer Shelf Indicates the weight limit for the printer shelf. The shelf is in
the proper position when two clicks are heard, indicating that
both support brackets are locked into place.
Keyboard/Monitor Indicates the safe swing path of the keyboard/monitor arm on

the instrument. Swinging the arm beyond this zone presents a
striking hazard to materials on the shelf and to the IMT lid.
9-5
Label Description
Vessel Label Indicates the appropriate reaction vessel to utilize in the

reaction vessel holder.
IFU Consult Instructions For Use.
Electrical Disposal Symbol Equipment is subject to European Directive on Waste Electrical

and Electronic Equipment (WEEE) 2002/96/EC, amended by
Directive 2003/108/EC. This symbol indicates separate
collection and return required.
Safety Rating Symbol Certified to the following standards and regulations:

• CAN/CSA C22.2 No. 61010-1: 2004, Safety requirements
for Electrical Equipment for Measurement, Control, and
Laboratory use, Part 1: General Requirements.
CAN/CSA C22.2 No. 61010-2-081: 2004, Safety
requirements for Electrical Equipment for Measurement,
Control, and Laboratory use, Part 2: Particular
requirements for automatic and semi-automatic
laboratory equipment for analysis and other purposes.
• CAN/CSA C22.2 No. 61010-2-101: 2004, Safety
requirements for Electrical Equipment for Measurement,
Control, and Laboratory use, Part 2: Particular
requirements for in vitro diagnostic (IVD) medical
equipment.
• UL 61010-1: 2004, Safety requirements for Electrical
Equipment for Measurement, Control, and Laboratory
use, Part 1: General Requirements;.
• EN61010-1: 2001, Safety requirements for Electrical
use, Part 1: General Requirements.
• EN61010-2-081: 2002, Safety requirements for Electrical
use, Part 2: Particular requirements for automatic and
semi-automatic laboratory equipment for analysis and
other purposes.
• EN61010-2-101: 2002, Safety requirements for Electrical
use, Part 2: Particular requirements for in vitro diagnostic
(IVD) medical equipment.
• EN60825-1/A1: 2002 Safety of Laser Products, Part 1:
Equipment classification, requirements and user guide.
9-6
Symbols Key
Figure 9-1: IFU Symbols Key
9-7
Instrument Labeling
Figure 9-2: Instrument Labeling Diagram - Front Open View
Figure 9-3: Instrument Labeling Diagram - Doors Open View
9-8
Performing Power Shutdowns and Startups

Types of Shutdowns
There are two procedures for removing power from the Dimension EXL system:
Controlled Power Shutdown and Emergency Power Shutdown. Use the
Controlled Power Shutdown when required for performing certain
maintenance procedures. Use the Emergency Power Shutdown when safety is
the primary reason for removing power.
The procedures in this section are for removing power from the Dimension EXL
system only.
Table 9-2: Power Shutdown Types
Shutdown What it does
Controlled Removes power from all areas of the instrument except the compressor.
Before shutting the instrument down, perform a data backup to ensure that
all data and alignment files are saved. The Controlled Shutdown may be
required to perform maintenance procedures.
Emergency Removes power from the entire instrument. No data backup is performed
before power loss. Although the instrument performs an automatic data
backup every 2 hours, any changes to files after the backup and before the
shutdown are not saved.
To remove power from the RMS only or from both the Dimension EXL system
and the RMS, see the RMS Operator’s Guide.
Important Power Safety Information

The Dimension EXL system uses an online double conversion un-interruptible
Power Supply (UPS) to provide power to the instrument should a power surge
or power outage occur.
The power down procedures must be followed in the exact sequence they are
presented, for the following reasons:
• Turning OFF power at the instrument's main power switch activates a
signal that prevents the UPS from providing power to the instrument
components when the instrument power cord is disconnected from the
wall outlet.
• If the instrument main power switch is ON, you must press the UPS
power button to turn the UPS OFF, even if you have removed the
instrument power cord from the wall outlet. If the power to the UPS is
OFF (i.e. the is no power coming from the outlet), the UPS will supply
power to the instrument to allow tests on the cuvette ring to complete
before performing a controlled power shutdown.
9-9
Performing a Controlled Power Shutdown

1. With the system in Standby mode, from the Operating Menu press EXIT.
2. When the prompt Do you really want to exit? (Hit EXIT to confirm,
ENTER to continue) displays, press the EXIT key.
3. When the prompt If you really want to shut the system down, type 'y'.
displays, press the Y key.
4. Wait for the Console Menu to display.
5. Select option 4 or press ALT+4.
6. Wait for the Shutdown menu to display and select option 2 or press ALT+
2 to shutdown.
7. When the message Do you really want to shutdown the computer?
displays, touch option 1 or ALT+1 key.
8. Push the instrument main power switch to the down position.
Restoring Power After a Controlled Shutdown

1. Push the instrument main power switch to its up (|) position.
2. At the console menu, select option 1 or press ALT+1 to start the system.
3. When the Operating Menu displays, run a System Check and the
laboratory’s daily QC to ensure that all instrument systems are operating
properly.
Performing an Emergency Shutdown

1. Open the left cabinet door.
2. Locate and push the main power switch to its down (O) position.
Figure 9-4: Main Power Switch
3. Turn OFF the UPS power by turning off the main power switch located at
the rear of the UPS, then press the UPS Off button at the front of the UPS.
The UPS will shutdown in approximately 30 seconds.
9 - 10
WARNING: Full power is provided to the instrument by a fully-charged

UPS for 21 minutes, even after the power cord is
disconnected. Ensure that the OFF button on the front of the
UPS is pressed.
Figure 9-5: UPS Front and Rear
4. Disconnect the instrument power cord from the outlet.
Restoring Power After an Emergency Shutdown

1. Connect the instrument power cord to the outlet.
2. Press the UPS ON/OFF power switch located on the rear of the
instrument. Do not press the button located on the front panel.
3. Push the instrument main power switch to its up (|) position.
4. At the console menu, select option 1 or press ALT+1 to start the
5. When the Operating Menu appears, run a System Check and the
laboratory’s daily QC to ensure that all instrument systems are operating
properly.
9 - 11
General Code Compliance Information
Safety Compliance
The Dimension EXL with LM system has been designed and tested to comply
with these safety standards:
• EN61010-1 (2001)
• EN61010-2-081 (2002)
• EN61010-2-101 (2002)
• EN61326
• EN61326-1
• EN61326-2-6
• CAN/CSA-C22.2 No. 61010-1 (2004)
• CAN/CSA-C22.2 No. 61010-2-081 (2004)
• CAN/CSA-C22.2 No. 61010-2-101 (2004)
• UL61010-1 (2nd edition)
under the following environmental conditions [subclause 1.4]:
Table 9-3: Safety Compliance
Temperature 5°C (41°F) to 40°C (104°F)
Humidity Maximum 80% at 31°C to 50% at 40°C
Altitude Maximum 2,000 m (6,562 ft)
Mains supply 115 ±10% VAC or 230 ±10% VAC, 50/60 Hz, 100+/-10% VAC
Overvoltage Category Category II, connected to a branch circuit
Pollution Degree Degree 2, normal indoor laboratory environment. Air contains only
non-conductive pollutants with occasional condensation.
Additional instrument-specific functional environmental conditions are in

Chapter 2.
Barcode Scanner
The barcode scanner uses Class I LEDs (light-emitting diodes), and is not
hazardous to your eyes.
WARNING: The Dimension EXL system should not be used next to any
Industrial Scientific and Medical (ISM) equipment that must
functionally produce RF energy (such as Diathermy
Equipment).
9 - 12
Installation Specifications
The Dimension EXL system is installed by a qualified Siemens representative.
Installation includes a full checkout to ensure that the equipment is fully
operational.
Space Requirements For Dimension EXL with LM System

Weight
1095 lb. (496 kg)
Dimensions
Length: 82 in. (208 cm)
Height: 49 in (124 cm) (without raised lids)
Height: 74 in. (188 cm) (Height includes raised lids)
Depth: 41 in. (104 cm)
These dimensions are without the printer shelf elevated.
Add 18 in. (46 cm) to the length if the printer shelf is used.
Minimum Clearances
Left Side: 24 in. (60 cm)
Right Side: 3 in. (8 cm)
Rear: 5 in. (13 cm) beyond LOCI module
The instrument requires 360-degree access and at least 36 in. (91 cm) of
working space on each side. Access to the rear of the instrument requires
moving it forward.
No leveling is required. However, a reasonably level floor is required for proper
operation. The two front casters of the instrument should be in their locked
position during operation.
9 - 13
Space Requirements For Dimension EXL 200 System

Weight
770 lb. (349 kg)
Dimensions
Length: 56 in. (142 cm)
Height: 49 in (124cm) (without raised lids)
Height: 72 in. (183 cm) (Height includes raised lids)
Depth: 40 in. (102 cm)
These dimensions are without the printer shelf elevated.
Add 16 in. (41 cm) to the length if the printer shelf is used.
Minimum Clearances
Left Side: 24 in. (60 cm)
Right Side: 3 in. (8 cm)
Rear: 5 in. (13 cm) beyond LOCI module
The instrument requires 360-degree access and at least 36 in. (91 cm) of
working space on each side. Access to the rear of the instrument requires
moving it forward.
No leveling is required. However, a reasonably level floor is required for proper
operation. The two front casters of the instrument should be in their locked
position during operation.
Power Requirements
Power Specifications
Table 9-4: Power Specifications
Maximum
Nominal Line Line Voltage Nominal Line Maximum
Continuous
Voltage vac Range vac Frequency Hz Power
Current
EXL System 100 90 to 110 47 to 63 ~13.5A 1900W

115 103 to 127 47 to 63 ~11A 1900W
230 207 to 253 47 to 63 ~5.5A 1900W
RMS 100 90 to 110 47 to 63 ~ 5.5A 550W

115 103 to 127 47 to 63 ~ 4A 550W
230 207 to 253 47 to 63 ~ 2.4A 550W
9 - 14
Table 9-5: Thermal Printer Power Specifications
Nominal Line Line Voltage Nominal Line Maximum

Continuous
Voltage vac Range vac Frequency Hz Power
Thermal 100 90 to 110 47 to 63 ~1.5A 100W

Printer 115 103 to 127 47 to 63 ~1.5A 100W
230 207 to 253 47 to 63 ~0.75A 100W
Table 9-6: Power Specifications (contd)
Service 100V AC, 50/60 Hz, Single Phase, 20A

115V AC, 60 Hz, Single Phase, 20A
230V AC, 50 Hz, Single Phase, 16 A
Transient Overvoltage Installation category II (branch circuit)
Circuit A separate dedicated circuit with grounded 3-wire distribution to the

receptacle is required. The third (green) ground wire should be an
isolated ground that initiates at the distribution panel and is
continuous to the receptacle in accordance NEC paragraph NEC
250-146(D), exception 4 (Reference: NATIONAL ELECTRICAL CODE
2005 Edition, ARTICLE 250 — GROUNDING AND BONDING), or current
guideline, unless local codes prohibit. The ground wire should not be
tied to grounds from other loads.
Shield Not required.
Ground Should initiate at distribution panel unless local codes prohibit.
Wire Size Number 10 AWG minimum.
Receptacle Hospital grade receptacle must be installed by the hospital electrician

before the instrument arrives. The receptacle must be accessible to the
9 foot (2.74 meter) power cord furnished with the instrument.
Leakage Current
Table 9-7: Leakage Current
Supply Voltage and Frequency 115VAC/60 Hz 230V AC/50 Hz
Normal Supply Connections Under 10 µA Under 100µA
Ground Disconnected Under 70 µA Under 150µA
Leakage current complies with the requirements of CSA C22.2 No.1010.1 safety standards for
laboratory equipment in non-patient vicinity areas.
Water Requirements
The Dimension EXL system requires and external source of CLSI Clinical
Laboratory Reagent Water or the use of a Purified Water Diluent. The external
system must be connected to the water inlet. Maximum rate of water
consumption and maximum rate of liquid waste output is 0.53 gal. (2.0 L)/hr.
Drain line check valves are installed to prevent back siphoning. Maintenance of
the disposal point is the responsibility of the operator and should be selected
in accordance with local hazardous waste guidelines.
9 - 15
The purified water supply systems for the Dimension EXL system must produce
water to the specifications shown below which meet the definition of CLSI
Clinical Laboratory Reagent Water (Clinical Laboratory Standards Institute,
C3-A4, Vol. 26, No. 22). Water supply maximum valve pressure is <55 psi
9 - 16
Table 9-8: Water Requirements
Parameter Units Specification
Ionic Purity megohm-cm, 25°C ≥ 10
Microbiological Impurities Colony Forming Units/mL < 10
Organic Impurities ng/gas < 500
Particulate Content µm < 0.22
Dissolved Oxygen1 ppm 5 to 8
TOC (Total Organic Carbon) ppb <500
1Not applicable to CLSI Clinical Laboratory Reagent Water (CLRW), but required for proper
instrument performance.
Room Temperature Requirements

Normal indoor environment is acceptable. Pollution degree 2: nonconductive
pollution with occasional condensation.
Room temperature must be between 64°F (18°C) and 86°F (30°C), with a
maximum fluctuation of 5°F (2.8°C) per hour.
Relative humidity must be maintained at ≥ 20% and ≤ 80%.
Average thermal output of the instrument (Btu/hr): 5293
The system requires 120 minutes (maximum) to warm up to incubation
temperature from a cold start.
External Un-interruptible Power Source (UPS)

The Dimension EXL system includes a large external UPS which maintains
power to the instrument. If the power to the UPS is OFF (i.e. there is no power
coming from the outlet), the UPS will supply power to the instrument to allow
tests on the cuvette ring to complete before performing a controlled power
shutdown.
The UPS:
• Must be installed in the same room as the Dimension EXL System
• Should be installed on the left side of the instrument; if the UPS
needs to be installed behind the Dimension EXL system, allow for
11 in. (28 cm) of clearance between the UPS and any wall.
For further information, see the manufacturer's manual accompanying the
UPS.
9 - 17
Printer Shelf
Note: The printer shelf can support a maximum of 50lbs. (23kg)
The Dimension EXL system includes a shelf folded into the left side which can
hold the printer.
1. To raise the shelf, grasp the lower edge and pull out and up until the
supports click into position. Press slightly on the shelf to ensure the
supports are fully engaged.
2. To lower the shelf, pull up on the release levers on both supports. Push
the shelf down and toward the instrument until it clicks into its storage
position
Additional Requirements
Phone Line
A dedicated, direct phone line will be connected to the Dimension EXL system
for its exclusive use.
Host Interfacing
For host interfacing, a 9-pin female connector is required for hookup to the
male connector on the Dimension EXL system host communications port.
Specifications for this phone line are:
• Full Duplex - capable of two way transmission.
• Standard analog phone jack connection - RJ11C or RJ11W (Digital
not supported).
Figure 9-6: Interface Port
9 - 18
English to Selected Language Keymap

When a lab selects a language for the Dimension application screen text, the
instrument will remap the keyboard to provide characters specific to the lab’s
selected language and any replacement key caps used by the lab for an
alternate character set.
A new feature allows the operator to toggle between the US English keymap
and the lab language specific keymap. Pressing <Alt><Spacebar> will toggle
between the US and the language specific keymap. When the keyboard is
mapped for a lab specific language other than English, a dark blue border will
appear around the screen area. The dark blue border will not appear, if the US
English keymap is used.
The instrument will revert to the US English keymap when the instrument
shuts down to the CONSOLE MENU. The operator must press <Alt><Spacebar>
to restore the lab language specific keymap after the instrument boots to the
OPERATING MENU.
9 - 19
Instrument Labels
HM Wash Diagram
Figure 9-7: HM Wash Diagram
9 - 20
IMT Tubing Diagram

Figure 9-8: IMT Tubing Diagram
9 - 21
Pump Panel Tubing Diagram

Figure 9-9: Pump Panel Tubing Diagram
9 - 22
Cuvette Film Diagram

Figure 9-10: Cuvette Film Diagram
9 - 23
9 - 24
Manual Review Documentation
Review Date Adopted Revised Title of Reviewer Reviewer Signature Notes
Use the notes column to document all revisions made to a method and/or any method revision levels sent by manufacturer.
Manuals must be reviewed by supervisor/lab manager at a minimum frequency of once per year per CLSI/NCCLS GP2-A5 guidelines.
10 - 1
10 - 2
Dimension System Logs
11- 1
Dimension EXL with LM/EXL 200 Integrated Chemistry System

ATTENTION!
Do Not Mark These Log Sheets.
Use them as Masters to make copies as needed
This package of Maintenance Log Masters contains 6 Logs:
Log 1 - Daily Maintenance
Log 2 - Daily System Check - ABS
Log 3 - Daily System Check - CHK
Log 4 - QuikLYTE Results
Log 5 - Weekly/Monthly Maintenance
Log 6 - Instrument Log
• Record maintenance information in the appropriate columns of these
maintenance logs as you perform these procedures.
• Use the Instrument Log (log 6) to record any maintenance performed that
is not part of scheduled maintenance, such as Replacing the Source Lamp.
• Procedures for the scheduled maintenance listed in these logs are detailed
in the Operator’s Guide. Refer to these procedures as necessary.
• Complete documentation of maintenance procedures is beneficial in
instrument and chemistry troubleshooting.
The Dimension EXL system is designed to process clinical laboratory
specimens, some of which may be a potential biohazard. It is important to
follow standard laboratory practice for protection from biohazards when
specimens are placed on the instrument and when maintenance and
troubleshooting procedures are performed.
11 - 2
Log 1 - Daily Maintenance Log

Table 11-1: Daily Maintenance Log
Dimension EXL with LM and Dimension EXL 200 integrated chemistry system
Instrument Serial Number: _____________________ Month & Year: ____________________
Record Temperatures (Cº)
RMS RMS Empty Run

Cuvette Reagent HM Hydration* Reagent* Cuvette System Operator
# Waste Check
36.8 to 37.2 2 to 8 37.3-39.6 2 to 8 2 to 8 Initials
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
*RMS is applicable to Dimension® EXL ™ with LM
11- 3
Instrument Serial Number: _____________________ Month & Year: ____________________
Record Temperatures (Cº)
RMS RMS Empty Run

Cuvette Reagent HM Hydration* Reagent* Cuvette System Operator
#
36.8 to 37.2 2 to 8 37.3-39.6 2 to 8 2 to 8 Waste Check Initials
25
26
27
28
29
30
31
*RMS is applicable to Dimension® EXL ™ with LM
11 - 4
11- 5
Log 2 - Daily System Check ABS

Table 11-2: Daily System Check ABS
Dimension EXL with LM and Dimension EXL 200 integrated chemistry system: Daily System Check (ABS)
Instrument Serial Number: ________________ Month & Year: ____________
Are all LOCI®

wavelength Reagent 1 Reagent 2 Sampler HM RMS* Highest
s Value
Mean SD Mean SD Mean SD Mean SD Mean SD

ABS Operator
293 Filter: Lot Initials
-2.5 to +2.5 10% of 10% of
ABS ABS ABS All
All other ABS ABS
Carton Carton Carton ≤ Values
filters: ≤ 3.8 ≤ 3.8 Carton ≤ 0.8 Carton ≤ 1.6
-1.5 to + 1.5 Value ± Value ± Value 3.8 0.001 to
Value Value
12 12 ±12 0.144
±2 ±4
10
11
12
13
14
15
16
17
18
19
20
21
22
23
*RMS is only applicable to Dimension® EXL ™ with LM
11 - 6
Dimension EXL with LM and Dimension EXL 200 integrated chemistry system: Daily System Check (ABS)
Are all LOCI®

wavelength Reagent 1 Reagent 2 Sampler HM RMS* Highest
s Value

ABS Operator
293 Filter:
Lot Initials
-2.5 to +2.5 10% of 10% of
All other ABS ABS ABS All
ABS ABS
Carton Carton Carton ≤ Values
filters: ≤ 3.8 ≤ 3.8 Carton ≤ 0.8 Carton ≤ 1.6
-1.5 to + 1.5 Value ± Value ± Value 3.8 0.001 to
Value Value
12 12 ±12 0.144
±2 ±4
24
25
26
27
28
29
30
31
11- 7
11 - 8
Log 3 - Daily System Check CHK

Table 11-3: Daily System Check CHK
Dimension EXL with LM and Dimension EXL 200 integrated chemistry system: Daily System Check (CHK)
LOCI®
Are all
Reagent 1 Reagent 2 Sampler HM RMS* Highest
wavelengths
Value

CHK Operator
293 Filter: Lot Initials
-2.5 to +2.5 10% of 10% of
CHK CHK CHK All
All other CHK CHK
filters: Carton Carton Carton Values
≤ 3.8 ≤ 3.8 Carton ≤ 1.6 Carton ≤ 1.6 ≤ 3.8
Value ± Value ± Value 0.001 to
-1.5 to + 1.5 Value Value
15 15 ±15 0.144
±2 ±4
10
11
12
13
14
15
16
17
18
19
20
21
22
23
11- 9
Dimension EXL with LM and Dimension EXL 200 integrated chemistry system: Daily System Check (CHK)
LOCI®
Are all
Reagent 1 Reagent 2 Sampler HM RMS* Highest
wavelengths
Value

CHK Operator
293 Filter:
Lot Initials
-2.5 to +2.5 10% of 10% of
All other CHK CHK CHK All
CHK CHK
Carton Carton Carton Values
filters: ≤ 3.8 ≤ 3.8 Carton ≤ 1.6 Carton ≤ 1.6 ≤ 3.8
-1.5 to + 1.5 Value ± Value ± Value 0.001 to
Value Value
15 15 ±15 0.144
±2 ±4
24
25
26
27
28
29
30
31
11 - 10
11- 11
Log 4 - QuikLYTE Results

Table 11-4: QuikLYTE Results
Dimension EXL with LM and Dimension EXL 200 integrated chemistry system QuikLYTE Results
Instrument Serial Number: _______________ Month & Year: _________________
Slope Std A Na K Bias
Na K Cl Air Liq. Mean SD Mean SD %
Na K
53 to 53 to Bottle Bottle
Date -55 to -40 > 0.8 < 0.6 <1.4 <0.04 ≤ 1.0 Initials
65 65 Value Value
140.00 4.00
11 - 12
11- 13
Log 5 - Weekly/Monthly Maintenance

Table 11-5: Weekly/Monthly Maintenance
Weekly/Monthly Maintenance
Instrument Serial Number: ___________ Year: _______
Weekly
Monthly
(HM)
Clean Clean Clean Clot Replace Stylette Replace

Clean Replace/ Clean
Outside Outside of Check IMT HM HM Clean R3 Operator
Date IMT Clean Air R1/R2
of R2 HM Wash Drain on Pump Wash Pump Drain** Initials
System* Filters Drain
Probe Probes IMT Port Tubing Probes Heads^
* If more than 100 IMT samples are run daily, clean IMT System every 15 days.
** Instruments with RMS Only
^ Perform System Check after replacing HM pump heads
11 - 14
11- 15
Log 6 - Instrument Log

Table 11-6: Instrument Log
Instrument Log
Instrument Serial Number: ___________ Year: ___________
Date & Initial Procedure Performed Comments
11 - 16
11- 17
11 - 18
Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide Index
Chapter 12: Index
A
About this Guide 1-1
How this Guide is Organized 1-4
About this guide
Using this Guide 1-2
Air Filters
Replacing 5-12
Alert Keys 8-48
Configuration Calibration Alerts 8-50
Configuring QC Alerts 8-50
Configuring STAT Status 8-48
Configuring the Supplies Alert 8-49
Alignments 6-1
Barcode Scanner 6-3
Cuvette Ring 6-5
General Information 6-2
HM Module 6-7
LOCI® Arm 6-15
Offsets 6-2
Printing and Viewing 6-2
Photometer 6-17
R1 Reagent Probe 6-18
R2 Reagent Probe Alignments 6-22
Reagent Tray Alignment 6-27
Sample Probe 6-29
Appendix
Calibration (Verification) Review Flow Chart 4-22
Calibration (Verification)Setup Flow Chart 4-21
Keystroke Combinations 1-19
Operating Passwords 1-20
Understanding Test Report Messages 3-17
Automated System Check
CHK 8-7
Automatic Panic Rerun 8-12
Setting Up 8-12
12 - 1
Index Dimension® EXL ™ with LM/EXL ™ 200 System Operator’s Guide
Automatic Reflex Testing 8-10

Setting Up 8-10
C
Calculated Results 8-15
Calibration 4-2
Alerts 8-50
Calibration Alert 4-4
Configuration
Definine Calibration Auto Acceptance Parameters 8-20
Definine Calibration Product 8-19
Edit Calibration Product 8-19
Entering Data Manually 8-19
Scanning Barcode Data 8-19
Cuvette System Temperature 5-23
Group 4-5
Alerts 4-5
HA1C 4-3
HB1C 4-3
HM Temperature 5-27
IMT 4-18
Electrolyte Coefficients 4-18
IMT System 4-2
Overview 4-2
Photometric and LOCI® Methods 4-3, 4-6
Cancelling Calibration 4-8
Reviewing and Accepting Results 4-7
Setting Up and Running a Calibration 4-6
Viewing History 4-9
Reagent System Temperature 5-25
Review Flow Chart 4-22
Setup Flow Chart 4-21
Troubleshooting 4-11
Calibration Statistics 4-11
Precision of Calibration Results 4-11
Quality Control 4-12
Urine Drugs of Abuse Methods 4-3
User-Defined Methods 8-92
Using Status Lists 4-19
Create a List of Methods 4-19
Create a Reminder List for Expiring Calibrations 4-20
Removing Calibrations from Instrument Memory 4-20
Verifying Photometric Methods 4-13
Calibration and Quality Control 4-1
Calibrating Photometric and LOCI® Methods 4-6
Calibrating the IMT System 4-18
Calibration Troubleshooting 4-11
Calibration/Verification Overview 4-2
Group Calibration Alerts/Run Calibration Group 4-5
Using Calibration Status Lists 4-19
Verification Troubleshooting 4-16
Verifying Photometric Methods 4-13
12 - 2
Card Cage
Control Board 5-136
Chemistry Troubleshooting 7-5
How to Troubleshoot 7-5
Imprecision 7-7
Inaccuracy 7-6
Printing Filter Data for Test Results 7-7
QC Results Out of Range 7-6
When to Troubleshoot 7-5
CHK
Configuring Automated System Check 8-7
Enter New Carton Value 7-9
Flex Reagent Cartridge Information 2-6
Running A System Check 2-3, 5-138
Specifications 2-5
Clot Check 3-4, 3-11
Clot Check Err Message 3-22
Configured 8-3
Drain on the IMT Port 5-8
Replacing Sample Tubing 5-126
Status Icons 1-29
Clot Check Overview 7-15
Code Compliance
Safety Compliance 9-12
Configuration
Flex® Cartridge 8-85
IMT 8-32
Consumable Screen
IMT 2-23
Correlations 8-23
Correlation Study 8-23
Dimension® EXL ™ System with Other Methods 8-23
Entering Observed Results for System Calculation 8-25
Entering Slope And Intercept 8-26
Printing a List of Correlated Methods 8-27
Removing a Correlation 8-27
Result Reporting For Methods 8-24
Using the Correlation Feature 8-24
Customizing 8-1
Automatic Cuvette Removal 8-8
Automatic Panic Rerun 8-12
Automatic Reflex Testing and Panic Rerun Report Slips 8-13
Calibration Configuration 8-19
Configuring the Printer 8-51
Configuring Touch Screen Alert Keys 8-48
Correlations 8-23
Creating Panel Keys 8-43
Entering Method Parameters 8-33
Entering Sample ID Information 8-58
External Printer Report 8-52
HIL Feature 8-44
IMT Configuration 8-32
Overview 8-2
12 - 3
Performing Reagent Hydrations 8-28

Selecting a Test Result Order 8-75
Selecting Instrument Options 8-3
Storing Laboratory Data 8-63
Test Key Assignments 8-76
Using Calculated Results 8-15
Using Test Counters 8-62
Using the Result Monitor Feature 8-55
Cuvette
Automatic Removal 8-8
Diaphragm 5-37
Emptying Waste 2-2
Film Cartridge 5-41
Film Cartridge Icon 1-27
Ring Alignment 6-5
Ring Sensor 5-49
Spring Tip and E-Clip 5-45
Temperature Icon 1-26
Window
Cleaning 5-29
Removing and Installing 5-32
Windows 5-28
D
Daily Setup 2-2
Checking for Other Maintenance 2-3
Cleaning the Sample Area and Emptying Cuvette Waste 2-2
Managing Offboard Reagent Lots 2-8
Overview 2-2
Recording Daily Maintenance Results 2-3
Running a System Check 2-3
Understanding the System Counters Screen 2-7
Decontamination 5-139
E
Entering and Running Batch Samples 2-40
Entering Sample Data 2-37
Entering Sample Data Screen Fields 2-38
Error Messages 7-13, 8-104
Active System Errors Screen 7-13
Error Log Screen 7-13
Software Error Troubleshooting Help 7-13
User-Defined List 8-104
F
Flex®
Cartridge Configuration 8-85
Cartridge Configuration Fields 8-86
Filling a Cartridge 8-90
Loader Home Sensor 5-50
Loading Cartridge 8-91
Presence Sensor Board 5-51
12 - 4
Fuses 5-52
Replacing AC 5-52
Replacing DC 5-53
G
General Instrument Care and Cleaning 5-2
Materials for Cleaning 5-2
Opening the LOCI® Access Lid 5-3
Opening the Reagent Lid 5-3
Removing the HM Incubation Wheel Cover 5-4
H
Heat Torch Assembly 5-54
HIL 8-44
Alert Index Values 8-45
Setup 8-46
Histogram Plot 4-34
Printing Information 4-34
HM Consumables 2-18
Replacing HM Fluids 2-18
HM Incubate Wheel 5-58
HM Incubation Wheel Cover 5-4
HM Module
Alignments 6-7
HM Pump 5-62
HM Pump Heads
Replacing 5-17
HM Wash Probe 5-66, 5-68
Tubing 5-71
HM Wash Probes 5-5
Styletting 5-14
HM Wash Wheel 5-72
Alignment 6-8
I
IMT
Cleaning the System 5-11
Configuration 8-32
Bleach/Condition Soak Interval 8-32
ECO2 Test Method 8-32
Consumables Screen 2-23
Miscellaneous Tubing 5-73
Pump Tubing 5-10
Rotary Valve Seal 5-77
Rotary Valve Tubing 5-80
Using the IMT Consumables Screen 2-22
Using the IMT Logs 2-28
Waste Tubing 5-34
IMT Consumables 2-28
Replace 2-22
Replacing the QuikLYTE® Integrated Multisensor 2-24
Resolving a Failed Dilution Check 2-26
Running a Dilution Check 2-25
12 - 5
IMT Troubleshooting 7-14

Error Message 7-14
IMT Results 7-14
IMT Tubing 5-75
Installation Specifications
Room Temperature Requirements 9-17
Space Requirements For Dimension® EXL ™ 200 System 9-14
Dimensions 9-14
Minimum Clearances 9-14
Weight 9-14
Space Requirements For Dimension® EXL ™ with LM System 9-13
Dimensions 9-13
Minimum Clearances 9-13
Weight 9-13
Instrument Options 8-3
Select/Change 8-3
System Configuration Menu Function Keys 8-5
System Configuration Menu Screen Fields 8-3
System Configuration Secondary Menu Screen Fields 8-6
L
Laboratory Data 8-63
Understanding Data Fields 8-65
Levey-Jennings Plot 4-35
Patient Results 4-35
Printing L-J Patient Information 4-35
Printing L-J QC Information 4-36
QC Results Plot 4-35
Load Errors 3-11
Load List Errors 3-12
Loading Samples 2-41
LOCI®
Arm Alignment 6-15
Arm to Detector Alignments 6-16
Arm to Vessel Alignments 6-15
Insert 5-82
Vacuum Cup 5-83
M
Maintenance 5-1
General Instrument Care and Cleaning 5-2
Monthly Maintenance 5-8
Other Maintenance 5-21
Weekly Maintenance 5-5
Maintenance Logs
Using the Daily Maintenance Logs Screens 2-5
Major Components of the Dimension® EXL ™ system
Major Components of the HM Area 1-10
Major Components of the IMT Area 1-9
Major Components of the LOCI® Module 1-14
Major Components of the Printer Area 1-13
Major Components of the Reagent Area 1-11
Major Components of the Thermal Chamber Area 1-12
12 - 6
Materials for Cleaning 5-2

Bleach Solutions 5-2
Decontamination 5-2
Sodium Hydroxide Solutions 5-2
Undiluted Bleach 5-2
Method Kinetics 8-93
Screen 8-93
Screen Fields 8-94
Using 8-98
Method Parameters 8-33
Automatic Dilutions 8-36
Autodilute 8-36
Automated Urine Dilutions 8-36
Method Review
Histogram Plot 4-34
Levey-Jennings Plot Views 4-35
Method Review Screen Fields 4-37
Method Review Screen Function Keys 4-39
Results Listing View 4-33
Reviewing QC Results 4-42
Rules Field Definitions 4-40
Monthly Maintenance 5-8
Cleaning the Clot Check Drain on the IMT Port 5-8
Cleaning the IMT System 5-11
Cleaning the R2 and R3 Drains 5-19
Replacing IMT Pump Tubing 5-10
Replacing Instrument Air Filters 5-12
Replacing the HM Pump Heads on Wash Station 5-17
Styletting HM Wash Probes 5-14
O
Offboard Reagent Lots 2-8
Operating Passwords 1-20
Other Maintenance 5-21
Accessory Spare Parts Kit 5-21
Calibrating Cuvette System Temperature 5-23
Calibrating HM Temperature 5-27
Calibrating Reagent System Temperature 5-25
Checking 2-3
Cleaning Cuvette Windows 5-28
Cleaning the IMT Waste Tubing 5-34
Cleaning the Sample Probe and Drain 5-35
Cleaning the Water Bottle 5-37
Decontamination 5-139
Lowering and Raising the Thermal Chamber 5-21
Replace Sample Tubing (Clot Check Configured) 5-126
Replacing a Pump Limit Sensor 5-88
Replacing a Pump Solenoid Valve 5-93
Replacing a Pump Syringe 5-96
Replacing a Reagent Arm Radial Home Sensor 5-101
Replacing a Reagent Arm Vertical Home Sensor 5-102
Replacing a Reagent Probe Tip 5-106
Replacing an HM Pump and Motor Assembly 5-62
12 - 7
Replacing an HM Wash Probe 5-66

Replacing Fuses 5-52
Replacing HM Wash Probe Tubing 5-71
Replacing HM Wash Wheel 5-72
Replacing IMT Miscellaneous Tubing 5-73
Replacing Printer Paper 5-88
Replacing Sample Tubing 5-124
Replacing the Cuvette Diaphragm 5-37
Replacing the Cuvette Film Cartridge 5-41
Replacing the Cuvette Formation Spring Tip and E-Clip 5-45
Replacing the Cuvette Ring Sensor 5-49
Replacing the Flex® Loader Home Sensor 5-50
Replacing the Flex® Presence Sensor Board 5-51
Replacing the Heat Torch Assembly 5-54
Replacing the HM Incubate Wheel or Wash Wheel Home Sensor 5-58
Replacing the HM Wash Probe Home Sensor 5-68
Replacing the IMT Rotary Valve Seal 5-77
Replacing the IMT Rotary Valve Tubing 5-80
Replacing the LOCI® Insert 5-82
Replacing the LOCI® Vacuum Cup 5-83
Replacing the Photometer Filter Wheel Dual Sensor 5-84
Replacing the Photometer Home Sensor 5-86
Replacing the R2 Reagent Arm Rotational Home Sensor 5-104
Replacing the Reagent Tray Home Sensor 5-110
Replacing the Sample Probe Tip 5-120
Replacing the Source Lamp 5-127
Replacing the U-Seal Element 5-129
Replacing the Vacuum Pump Muffler Filter 5-134
Replacing the Water Bottle 5-135
Reseating a Control Board in the Card Cage 5-136
Running a System Check 5-137
Overview of the Dimension® EXL ™ System 1-5
Features 1-6
Major Components of the Dimension® EXL ™ system 1-8
P
Panel Keys 8-43
Pediatric Tubes
Using 2-34
Performing Power Shutdowns and Startups 9-9
Important Power Safety Information 9-9
Performing a Controlled Power Shutdown 9-10
Performing an Emergency Shutdown 9-10
Restoring Power After a Controlled Shutdown 9-10
Restoring Power After an Emergency Shutdown 9-11
Types of Shutdowns 9-9
Controlled 9-9
Emergency 9-9
Photometer
Alignment 6-17
Filter Wheel Dual Sensor 5-84
Home Sensor 5-86
12 - 8
Photometric Methods
Verification
Cancelling 4-15
Reviewing and Accepting Results 4-14
Setting Up and Running 4-13
Preparing Samples 2-2
Checking for Adequate Sample Volume 2-35
Placing Barcode Labels on Sample Tubes 2-35
Sample Preparation 2-35
Types of Containers 2-29
Using Pediatric Tubes 2-34
Using Primary Sample Tubes 2-31
Using Sample Cups 2-29
Using SSC (Small Sample Containers) 2-32
Configuring SSC (Small Sample Containers 2-32
Printer
Configuring 8-51
Paper 5-88
Processing Samples 2-43
Adding Samples While the System is Processing 2-43
Processing Samples from Standby Status 2-43
Samples Downloaded from an LIS 2-44
Configuring 2-44
Pump Limit Sensor 5-88
Pump Solenoid Valve 5-93
Q
QC
Alerts 8-50
Reviewing Results 4-42
QC Patient Results 4-32
Crossover QC 4-24
Daily QC 4-23
Defining QC Panels 4-29
Defining QC Products 4-28
Editing QC Panels 4-30
Editing QC Products 4-29
Entering Ranges 4-27
Grouping Alerts 4-31
New Reagent and Control Lots 4-24
Previously Defined QC Product 4-30
Program 4-23
QC Materials 4-24
Review 4-24
Setting Expiration Period and Checking Status 4-27
Urine Drugs of Abuse Methods 4-25
Using Alert Key 4-26
12 - 9
R
R1 Reagent Arm
Delivery 8-82
Drain Alignment 6-18
Target Cuvette Alignment 6-19
R2 Reagent Arm
Drain Alignment 6-22
HM Incubate Wheel Alignment 6-26
Probe Alignments 6-22
Reagent Arm Rotational Home Sensor 5-104
Target Cuvette Alignment 6-24
R2, R3 5-19, 8-83
Reaction Vessels 2-20
Adding Reaction Vessels 2-20
Discarding Reaction Vessels 2-21
Reagent Arm Radial Home Sensor 5-101
Reagent Arm Vertical Home Sensor 5-102
Reagent Cartridge Inventory 2-13
Adding Reagent Cartridges 2-14
Manually Entering a Reagent Cartridge Barcode 2-15
Removing Reagent Cartridges 2-16
Using Third Lots of Reagent Cartridges 2-17
Reagent Hydrations 8-28
Cancelling a Reagent Hydration 8-29
Hydrating a Specific Cartridge Lot 8-28
Hydrating Using the Inventory/Hydration Screen 8-29
Setting a Timed Hydration Schedule 8-30
Reagent Probe Tip 5-106
Reagent Temperature 1-25
Reagent Tray
Alignment 6-27
Reagent Tray Home Sensor 5-110
Reference Range Indicators 3-16
Replacing
IMT Consumables 2-22
Reports
External Printer 8-52
Creating 8-52
Customizing 8-52
Format 8-53
Result Monitor 8-55
Accumulated Results Side 8-55
Limits Side 8-55
Methods and Settings 8-56
S
Safety and Specifications
Safety 9-2
Biohazard and Probe Safety 9-2
12 - 10
Instrument Removal 9-2

General Safety 9-2
Instrument Labeling 9-8
Safety Labels 9-4
Safety Notes 9-3
Sample
Delivery 8-82
Sample ID 8-58
Sample Probe
Alignments 6-29
Cup 6-31
Cuvette 6-30
Drain 6-33
HM Incubate Wheel 6-33
IMT Port 6-35
Maximum Depth 6-36
Cleaning 5-35
Tip 5-120
Sample Processing and Test Reports
Determining Sample Status 2-46
Entering and Running Batch Samples 2-40
Loading Samples 2-41
Sample Troubleshooting 3-13
Understanding Test Results 3-2
Sample Processing and Test Results
Entering Sample Data 2-37
Preparing Samples 2-2
Sample Reports 3-1
Sample Status 2-46
Editing and Rerunning a Sample 3-10
Priority Load List Screen Errors 3-12
Reaction Vessel Status 2-52
Rerunning Tests Using Edit Sample 3-11
Rerunning Tests Using Load Errors 3-11
Sample Alert Key 2-49
Sample Status Screen 2-46
Searching for a Sample 3-8
Segment Status 2-50
All Segments 2-50
On-Board Segments 2-50
Viewing 2-50
STAT Status Alert Key 2-48
Viewing Sample Status 2-46
Sample Troubleshooting 3-13
Resolving a Short Sample Detected 3-13
Sample Tubing
Replacing 5-124
Samples 2-43
Setup and Supplies
Daily Setup 2-2
System Needs 2-9
Short Sample 3-13
Icon 1-28
12 - 11
Primary Tube Without Barcode 3-14

Sample Cup 3-15
SSC 3-15
Software Overview
Using the Keyboard 1-15
Function Keys 1-16

Action Keys 1-16
Pause 1-16
Reset 1-16
Run 1-16
Stop 1-16
Cursor Movement Keys 1-17
Keyboard Keys 1-17
1-17
Alt 1-17
Backspace 1-17
Enter 1-17
Tab 1-17
Keypad Keys 1-17
Alarm Off 1-17
Delete 1-17
Enter 1-17
Exit 1-17
Help 1-17
Numbers 1-17
PgDn 1-17
PgUp 1-17
Test Keys 1-15
Keyboard Overlays 1-16
Using the Touchscreen
Additional Touchscreen Keys 1-31
Alert Keys 1-31
Applications Area 1-30
Error Message Area 1-30
Function Keys Area 1-30
Instrument Status Area 1-21
Date and Time Box 1-23
IMT System Status Box 1-23
Photometric Sampler Status Box 1-22
Processing Status Box 1-22
Message Area 1-30
Operating Conditions Status Area Icons 1-24
Status Area Icons
Alarm Status 1-29
Check Needs 1-29
Clot Check Status 1-29
Cuvette Film Cartridge 1-27
Cuvette Temperature 1-26
Printer 1-28
Reagent Manager 1-28
Reagent Temperature 1-25
Short Sample 1-28
UPS 1-27
12 - 12
Store Laboratory Data 8-63

Storing Laboratory Data
How Data is Stored 8-63
System Check
Running 5-137
System Check Troubleshooting
7-8
Resolving Miscellaneous System Check Error Conditions 7-8
Unacceptable LOCI® Ranges 7-12
Unacceptable Mean or SD for a Reagent Arm 7-10
Unacceptable Mean or SD for HM Wash System 7-12
Unacceptable Mean or SD for the Sampler 7-11
System Configuration
Menu Screen Fields 8-3
Automatic Cartridge Removal 8-3
Automatic Dilution 8-3
Automatic Repeat for Panics 8-4
Automatic Rerun 8-3
Clot Check Configured 8-3
Enter Sample Data Mode 8-3
HM Module Configured 8-3
RMS Option Configured 8-3
Waste Out 8-3
Water In 8-3
System Configuration Menu Function Keys 8-5
System Counters 2-7
System Needs 2-9
Adding Reagent Cartridges 2-14
Adding/Discarding Reaction Vessels 2-20
Removing Reagent Cartridges 2-16
Replacing HM Consumables 2-18
Replacing HM Fluids 2-18
Replacing IMT Consumables 2-28
Responding to System Needs 2-9
Understanding System Needs 2-11
Review Reagent Cartridge Inventory 2-13
Supplies Alert 2-12
Using Third Lots of Reagent Cartridges 2-17
System Operations 2-1
System Overview
Overview of the Dimension® EXL ™ System 1-5
Software Overview 1-15
T
Test Counters 8-62
Test Keys 8-76
Assignments 8-76
Programming 8-77
Test Report 3-5
Messages 3-17
Abnormal Assay 3-17
Abnormal Reaction 3-17
Aborted Test 3-18
12 - 13
Above Assay Range 3-19

Absorbance 3-18
Antigen Excess 3-19
Aritmetic 3-19
Assay Range 3-20
Assay Range Diluted 3-21
Below Assay Range 3-21
Calibration Expired 3-21
Clot Check Err 3-22
Diluted 3-22
Dilution Examples 3-27
Hemoglobin 3-22
HI 3-23
High "A" Error 3-23
HIL Interf 3-23
hp 3-24
LO 3-24
Low "A" Error 3-24
lp 3-24
Measurement 3-24
Mixture of a Sample and a Known Standard 3-27
No Reagent 3-25
Not Calibrated 3-25
Priorities 3-29
Process Error 3-25
Substrate Depletion 3-25
Temperature 3-26
Test Report Messages
Test Results 3-16
Test Result Order 8-75
Test Results 3-2
Clot Check 3-4
Displaying Test Results 3-7
HIL Index 3-2
Reference Range Indicators 3-2, 3-16
Reporting Test Results 3-2
Test Report Messages 3-2
Reprinting Results 3-7
Test Report 3-5
Test Report Messages 3-16
Thermal Chamber 5-21
Lowering 5-21
Raising 5-22
Third Lots Reagent Cartridges 2-17
Touchscreen Alert Keys 8-48
TroubleShooting
Help Keys 7-2
Troubleshooting 7-1
Chemistry Troubleshooting 7-5
Clot Check Bypass 7-16
Error Messages 7-13
IMT Troubleshooting 7-14
Overview 7-2
Remote Access 7-4
12 - 14
Solving the Problem 7-3

Specifying the Problem 7-2
System Check Troubleshooting 7-8
When to Contact the Technical Solutions Center 7-3
U
Unacceptable Photometer Ranges
Photometer 7-9
Unacceptable Ranges 7-9
Understanding Data Fields
Daily Maintenance Fields mtdat.xls File 8-67
IMT Logs Fields imtdat.xls File 8-72
Instrument Log Fields instrdat.xls File 8-74
Photometric Calibration Fields cldat.xls File 8-69
QC Results Fields qcdat.xls File 8-65
Test Results Fields rsdat.xls File 8-66
Understanding the System Counters Screen 2-7
Dimension® EXL ™ System Counters Screen 2-7
Using Instrument Log Screen 2-7
UPS (Uninterruptible Power Source) 1-27
U-Seal Element 5-129
Calibration and QC 8-92
Customer Responsibility 8-80
Defining Flex® Cartridge Configuration 8-85
Defining Photometry Reading Times 8-84
Allowable Time Ranges 8-84
Defining Reagent and Sample Deliveries 8-81
Reagent and Sample Delivery Fields 8-83
Reagent Deliveries R2 and R3 8-83
Reagent Delivery R1 8-82
Sample Delivery 8-82
Defining the Calculation 8-87
Writing 8-87
Entering Method Parameters 8-90
Error Messages List 8-104
Filling a Flex® Cartridge 8-90
Flex® Cartridge Configuration Fields 8-86
Identifying the Method 8-80
Loading the Flex® Cartridge 8-91
Predefined Calculation Template 8-88
Fields 8-89
Programming Structure 8-99
Expressions 8-102
Functions 8-104
IF ELSE Statement 8-102
Implementation 8-99
Logical Expressions 8-103
Numerical Expressions 8-102
Statements 8-100
Programming Terms 8-99
Reviewing Method Kinetics 8-93
Running 8-92
Storing a Method 8-89
12 - 15
Warranty 8-80
Using this Guide
College of American Pathologists 1-2
For Additional Help 1-3
V
Vacuum Pump Muffler Filter 5-134
Verifcation Troubleshooting 4-16
Precision of Results 4-16
Statistics 4-16
W
Wash Wheel Home Sensor 5-58
Water Bottle 5-37, 5-135
Weekly Maintenance 5-5
Cleaning HM Wash Probes and the R2 Reagent Probe 5-5
12 - 16

Operator's Guide - Dimention

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Operator's Guide - Dimention

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Rev.

©2010–2019 Siemens Healthcare Diagnostics

Dimension® EXL ™ System Operator’s Guide

System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

System Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

Performing a System Check Using CHK . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

Processing Non-Barcoded Samples Downloaded from an LIS . . . . . . . . . . . . . . . . . 2-45

Sample Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

HIL Interf . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23

Remove Calibrations from Instrument Memory . . . . . . . . . . . . . . . . . . 4-20

Cleaning the R1, R2 & R3 Drains . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19

Replacing the U-Seal Element . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-129

Customer Care Center - Technical Solutions . . . . . . . . . . . . . . . . . . . . . 7-3

Edit Calibration Product . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-19

Photometric Calibration Fields in cldat.xls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-69

Restoring Power After an Emergency Shutdown . . . . . . . . . . . . . . . . . 9-11

Chapter 1: System Overview

Using this Guide

For Additional Help

How this Guide is Organized

1: System Overview Describes the contents of the guide, as well as

2: System Operation Describes everything that needs to occur in

3: Sample Reports Describes the reports and procedures that

5: Maintenance Procedures for preventive maintenance

6: Alignments Procedures for aligning instrument

7: Troubleshooting Procedures for resolving problems on the

8: Configuration Procedures for customizing features of the

Appendix Safety Labels, Compliance, Power Down/Up

Overview of the Dimension EXL System

Can perform tests in random order.

Can perform automatic reflex testing.

Can perform automatic panic reruns.

Can perform automatic dilutions on patient and QC urine samples.

Can perform up to 167 heterogeneous immunoassays per hour.

Can produce calculated results.

Can perform automatic rerun capability.

Can perform automatic dilution for over-range samples.

Can detect clots during sample aspiration.

Can process user-defined assays.

Can determine the usability of a sample using the HIL feature.

Utilizes automated CHK System Check.

Table 1-2: Features: Consumables

Can Perform automatic reagent preparation.

Can hold up to 44 Flex reagent cartridges in a non- CFC refrigeration system.

Can hold an additional 44 Flex reagent cartridges with RMS installed.

Table 1-3: Features: QC/Calibration

Utilizes automated calibration setup and acceptance.

Utilizes barcoded QC panel processing.

Table 1-4: Features: Software

Has an easy-to-use computer.

Has ten user-programmable panel keys.

Has touchscreen monitor with visual/audio alerts.

Table 1-5: Features: Sample Tubes

Uses various sizes and styles of primary sample tubes.

Uses 1.5-mL sample cups.

Major Components of the Dimension EXL System

13 Inner and Outer Barcode Readers

15 Cuvette Film Cartridge

16 Flex® Reagent Cartridge Loader

17 Cuvette Waste Container

Note: Dimension EXL 200 system does not have an RMS.

Major Components of the IMT Area

1 IMT Peristaltic Pump