DX IRM

Reference Manual
C95318-AA
December 2022
Printed in U.S.A.
© 2022 Beckman Coulter, Inc. All rights reserved.
Beckman Coulter, Inc. • 250 S. Kraemer Blvd. • Brea, CA 92821 • U.S.A.
https://www.beckmancoulter.com
Publication Notes
This manual, C95318-AA, release date 2022-12, supports:
• UniCel DxI published system software version 5, including full versions 5.1, 5.2, 5.3.0, 5.3.1, 5.5.0,
5.6.0, and 5.7.0.
• UniCel DxI published system software version 7, including full version 7.0.0.
Changes to this Revision

Chapter Page Change Description
Publication Notes Publication Notes Added software version 7.0.0.
Revision History:
C88925-AA, October 2022 UniCel DxI software versions 5.1, 5.2, 5.3.0, 5.3.1, 5.5.0, 5.6.0, and 5.7.0
C85242-AA, April 2022 UniCel DxI software versions 5.1, 5.2, 5.3.0, 5.3.1, 5.5.0, 5.6.0, and 5.7.0
C73200-AA, March 2021 UniCel DxI software versions 5.1, 5.2, 5.3.0, 5.3.1, 5.5.0, 5.6.0, and 5.7.0
C48058-AA, August 2020 UniCel DxI software versions 5.1, 5.2, 5.3.0, 5.3.1, 5.5.0, and 5.6.0
C38352-AB, March 2019 UniCel DxI software versions 5.1, 5.2, 5.3.0, 5.3.1, and 5.5.0
C38352, January 2019 UniCel DxI software versions 5.1, 5.2, 5.3.0, 5.3.1, and 5.5.0
This manual is intended for use with:

• The UniCel DxI 800 Access Immunoassay System
• The UniCel DxI 600 Access Immunoassay System.
This guide also can be used as supplemental material for the UniCel DxC 880i, 860i, 680i, and 660i Synchron
Access Clinical System Integrated Workstations. Not all instructions in this manual are applicable to the UniCel
DxC Synchron Access Integrated Workstation running in integrated mode. Refer to the UniCel DxC Synchron
Access Integrated Workstation Instructions for Use manual.
Beckman Coulter, Inc. grants a limited non-exclusive license to the UniCel DxI system owner or operator to
make a copy of all or a portion of this book solely for laboratory use.
May be covered by one or more patents - see www.beckmancoulter.com.
Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks
of Beckman Coulter, Inc. in the United States and other countries.
ProClin™ is a trademark of The Dow Chemical Company ("Dow") or an affiliated company of Dow.
Microsoft, Windows, and the Windows logo are either registered trademarks or trademarks of Microsoft Corporation in the United States and/or
other countries.
Citranox is a registered trademark of Alconox, Inc.
Contrad is a registered trademark of Decon Laboratories, Inc.
All other trademarks are the property of their respective owners.
UniCel DxI Reference Manual Table of Contents
Table of Contents
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface-1
1 System Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

1.1 System Technology Overview . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
1.2 Assay Technology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
1.3 Sample Processing Theory . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
1.4 Assay Calibration Theory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
1.5 Confirmatory Assay Theory . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-23
1.6 Device Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24
2 System Administration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

2.1 System Administration Overview . . . . . . . . . . . . . . . . . . . . . . . . 2-3
2.2 System Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
2.3 Supplies Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
2.4 SPU Bar Code Reader Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25
2.5 LIS Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-30
2.6 Data Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-35
3 Configuring Tests and Results . . . . . . . . . . . . . . . . . . . . . . . 3-1

3.1 Configuring Tests and Results Overview . . . . . . . . . . . . . . . . . . 3-3
3.2 Assay Protocol File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
3.3 Test Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
3.4 Ranges Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19
3.5 Test Panel Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25
3.6 Derived Result Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-35
3.7 Reflex Test Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-44
© 2022 Beckman Coulter, Inc. i

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Table of Contents UniCel DxI Reference Manual
4 Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
4.1 Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
4.2 Initialize System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
4.3 Prime Fluidics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
4.4 System Check Routines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
4.5 Analog and Digital Device Diagnostics . . . . . . . . . . . . . . . . . . 4-26
4.6 Mechanics and Alignments. . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-38
4.7 Carryover Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-43
5 Event Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

5.1 Event Log Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
5.2 Reviewing and Printing the Event Log. . . . . . . . . . . . . . . . . . . . 5-5
5.3 Troubleshooting Caution and Warning Events. . . . . . . . . . . . . 5-11
5.4 Event-Specific Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . 5-15
6 System Support Procedures . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

6.1 System Support Procedures Overview . . . . . . . . . . . . . . . . . . . . 6-3
6.2 Instrument Cover Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
6.3 Shut Down and Restart Procedures . . . . . . . . . . . . . . . . . . . . . 6-14
6.4 Fluidics Support Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-24
6.5 Rack and SPU Support Procedures. . . . . . . . . . . . . . . . . . . . . . 6-38
6.6 Reagent Pack Movement Support Procedures . . . . . . . . . . . . . 6-50
A System Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

A.1 Space and Environmental Requirements . . . . . . . . . . . . . . . . A-2
A.2 Performance Characteristics. . . . . . . . . . . . . . . . . . . . . . . . . . A-8
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Glossary-1
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Index-1
ii © 2022 Beckman Coulter, Inc.

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UniCel DxI Reference Manual Preface
Preface
About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface-2
UniCel DxI System Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface-2
Notes, Cautions, and Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface-3
Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface-3
© 2022 Beckman Coulter, Inc. Preface-1

C95318-AA
Preface UniCel DxI Reference Manual
About This This UniCel DxI Reference Manual provides the same content delivered in the Help
Manual system Reference Information book, but in a manual format.
NOTE
Most screen, window and report examples in this manual are based on the
UniCel DxI 800 system, and may show up to four reagent pipettors. The
UniCel DxI 600 system has two reagent pipettors.
UniCel The UniCel DxI system includes the following documentation.

DxI System • The UniCel DxI Help system, which provides detailed operating and
Documen- reference information, linked to the system software.
tation • The Instructions for Use, which contains information intended to be used
after you have become familiar with the Access 2 system.
• The LIS Vendor Information document, which provides interface information
for your laboratory information system vendor.
• The Operator's Guide and Reference Manual, which provide the same text
delivered in the Help system Operating Procedures and Reference
Information books. These manuals are available in the English language.
Manuals, Instructions for Use, and other supporting documents for your Access 2
system are available on the Beckman Coulter website. Examples of available
documents include:
• UniCel DxI Instructions for Use
• UniCel DxI Operator's Guide & Reference Manual
• Access 2/UniCel DxI LIS Vendor Information Document
• Access assay instructions for use
• Safety Data Sheets for Access assays and consumables
• Certificates of analysis
To view or download electronic copies of UniCel DxI system documentation, visit the
Beckman Coulter website at techdocs.beckmancoulter.com. To receive email alerts
when new or updated UniCel DxI system documents are released on the website,
register for the "My Technical Documents" notification tool.
Preface-2 © 2022 Beckman Coulter, Inc.

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UniCel DxI Reference Manual Preface
Notes, System documentation uses notes, cautions, and warnings to draw your attention to
Cautions, and important information, instrument operation instructions, and safety information.
Warnings
Graphic and Text Description
Notes highlight or provide additional information.

NOTE
Cautions emphasize the possibility of damage to the

CAUTION instrument.
Warnings emphasize the possibility of harm to a

WARNING person, either to the operator or to a patient because of
the possibility of erroneous results.
Table 1 Notes, Cautions, and Warnings
Technical For technical assistance with the UniCel DxI Access Immunoassay System:
Support • In the U.S.A. or Canada, contact Beckman Coulter Technical Support by
phone at 1-800-854-3633 or online at www.beckmancoulter.com. Before
using online support the first time, you will need to register online.
• Outside the U.S.A. and Canada, contact your technical support
representative.
NOTE
Be prepared to provide your system ID.
© 2022 Beckman Coulter, Inc. Preface-3

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Preface UniCel DxI Reference Manual
Preface-4 © 2022 Beckman Coulter, Inc.

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UniCel DxI Reference Manual 1: System Technology
1 System Technology
1.1 System Technology Overview .................................................................... 1-3
LIS Interface ..................................................................................................... 1-4
Integrated Workstations .................................................................................... 1-4
LAS Interface .................................................................................................... 1-4
1.2 Assay Technology ......................................................................................... 1-5
Paramagnetic Particles ...................................................................................... 1-6
Chemiluminescence .......................................................................................... 1-6
Competitive Binding Assays............................................................................. 1-6
Sandwich Assays............................................................................................... 1-7
Antibody Detection Assays............................................................................... 1-8
Reagent Packs ................................................................................................... 1-9
Assay Characteristics ...................................................................................... 1-10
1.3 Sample Processing Theory ......................................................................... 1-11
Process Monitoring ......................................................................................... 1-11
Reserve Volume .............................................................................................. 1-12
Onboard Dilutions........................................................................................... 1-13
Test Requests and Sample Processing ............................................................ 1-14
Supply and Calibration Verification ............................................................... 1-14
Sample Processing Order ................................................................................1-15
Reagent Addition ............................................................................................ 1-16
Sample Washing and Reading ........................................................................ 1-16
© 2022 Beckman Coulter, Inc. 1-1

C95318-AA
1: System Technology UniCel DxI Reference Manual
Sample Expiration........................................................................................... 1-17
1.4 Assay Calibration Theory ........................................................................... 1-18
Assay Calibration Types ................................................................................. 1-19
Quantitative and Semi-Quantitative Calibration............................................. 1-20
Qualitative Calibration .................................................................................... 1-22
1.5 Confirmatory Assay Theory ....................................................................... 1-23
1.6 Device Calibration ...................................................................................... 1-24
1-2 © 2022 Beckman Coulter, Inc.

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UniCel DxI Reference Manual 1.1: System Technology Overview
1.1 System Technology Overview

The UniCel DxI Access Immunoassay System is an in vitro diagnostic device used
for the quantitative, semi-quantitative, or qualitative determination of various analyte
concentrations found in human body fluids.
Access Immunoassay System assays are heterogeneous, enzyme-mediated assays.

During sample processing, coated paramagnetic particles react with patient sample
and assay-specific reagents to form immune complexes. A magnetic field
immobilizes the bound immune complexes while the unbound components are
washed away. Chemiluminescent substrate reacts with an enzyme label present in the
bound complexes and releases light. A luminometer measures the light emitted, and
the system converts this reading, measured in relative light units (RLUs), into a test
result. For more information, see Section 1.2: Assay Technology.
To optimize laboratory efficiency, the system provides continuous random access

processing. The system uses a real-time, multi-tasking environment to allocate
instrument resources and schedule assay steps to process various assay methodologies
at the same time. Pipetting, washing, and reading of multiple assays, in various stages,
can take place concurrently. While the instrument is processing samples, additional
samples can be loaded, reagents and system supplies can be replenished, and waste
containers can be emptied.
To maximize throughput, the UniCel DxI 800 instrument uses four reagent pipettors
to enable the instrument to perform dilutions and add reagents for four samples at
once. The UniCel DxI 600 instrument uses two reagent pipettors, and processes two
samples at once.

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1.1: System Technology Overview UniCel DxI Reference Manual
LIS Interface The UniCel DxI system can be directed by a laboratory information system (LIS)
through the LIS interface. When connected to an LIS, the UniCel DxI instrument
receives test requests from, and sends test results to, the LIS. The LIS interface
consists of two major components:
• The physical, or hardware, interface, which is a 9-pin EIA-232 serial port
located on the back of the external computer
• The logical, or software, interface, which includes the frame-layer protocols
and message formats for sending and receiving messages
For information about setting up the LIS interface on the UniCel DxI system, see
Section 2.5: LIS Setup. The LIS interface is explained in detail on the LIS Vendor
Information CD.
Integrated The UniCel DxI system can be integrated with the UniCel DxC (chemistry) system
Workstations and the UniCel CTA (closed tube aliquoter) to form the UniCel DxC Integrated
Workstation. There are four versions of the integrated workstation, depending on
which versions of the DxI and DxC systems are used.
• The DxC 660i combines the DxC 600, the UCTA, and the DxI 600
For information about integrated workstations, refer to the UniCel DxC Synchron
Access Integrated Workstation Instructions for Use manual.
LAS Interface The UniCel DxI system can be connected to a laboratory automation system (LAS),
such as the Power Processor system. When connected to an LAS, the UniCel DxI
instrument receives samples from a track in addition to samples that are loaded on the
sample presentation unit (SPU). The track can route samples to multiple instruments
in the laboratory.
An LAS connector unit diverts sample tubes from the LAS track, positions the tubes
under the DxI sample pipettor for aspiration, and then routes them back to the track.
The LAS interface on the UniCel DxI system consists of a sample pipettor mechanism
that extends horizontally beyond the back of the instrument to aspirate the required
volume of sample directly from the sample tube on the connector unit.
For information about connecting the UniCel DxI system to an LAS, see the
UniCel DxI LAS Vendor Information document.

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UniCel DxI Reference Manual 1.2: Assay Technology
1.2 Assay Technology

An immunoassay is an analytical method that uses antigen-antibody reactions to
detect or measure a specific antigen or antibody (analyte) in a sample of body fluid,
such as serum or plasma.
Access Immunoassay System assays employ paramagnetic particles in the solid phase
of the assay, and an enzyme-mediated chemiluminescent reaction in the detection
phase. The solid phase and detection technologies allow measurement of a broad
range of analytes.
Immunoassays use a variety of assay formats to measure or detect analyte in samples.

The most common formats are:
• Competitive binding
• Sandwich
• Antibody detection
The type of assay format used depends on the analyte being measured.
In general, assay formats use reagents that include:

• An enzyme-labeled antigen or antibody (conjugate)
• Coated paramagnetic particles
• Other assay-specific reagents (such as antigens or antibodies specific for the
analyte being detected, stripping agents, and buffered protein solutions)
Analyte in the sample reacts with the conjugate and assay-specific reagents to form
immune complexes that bind to the paramagnetic particles. A magnetic field separates
the particle-bound complexes from the unbound components, and washing removes
the unbound components from the system.
In the detection phase, a chemiluminescent substrate is added to the paramagnetic

particles. The substrate reacts with the enzyme label present in the bound immune
complexes and releases light. The luminometer measures the light output and the
system software calculates a test result.
The total assay time depends on the incubation time and number of wash cycles
defined in the assay protocol file (APF). Assays are optimized for rapid time to first
result. Most tests are completed in 15-30 minutes. The UniCel DxI 800 system can

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1.2: Assay Technology UniCel DxI Reference Manual
process tests at a rate of up to 400 tests per hour for one-step assays (assays with one
processing stage), or at a rate of up to 200 tests per hour for two-step assays (two
processing stages). The UniCel DxI 600 system can process one-step assays at a rate
of up to 200 tests per hour, and two-step assays at a rate of up to 100 tests per hour.
NOTE
The number of processing steps for each assay format is defined in the APF, and
can be different for each assay. The text and illustrations describing each format
are meant to provide you with an overview of the technology, not to represent a
specific assay format.
For more information about specific assays, see the reagent instructions for use.
Paramagnetic Access Immunoassay System assays use micron-sized paramagnetic particles, either
Particles directly or indirectly coated with antigen or antibody, to detect analyte in the sample.
After the analyte binds to the particles, a magnetic field pulls the particles to the side
of the reaction vessel (RV) to allow for complete aspiration of the wash fluid
containing the unbound analyte. The system resuspends the particles by adding wash
buffer while spinning the RV.
Chemilumi- Luminescence is the emission of light associated with the dissipation of energy from
nescence an excited substance. When this is caused by a chemical reaction, it is called
chemiluminescence.
The UniCel DxI system uses enzyme-mediated chemiluminescence. Assay conjugates

are labeled with the alkaline phosphatase enzyme. The enzyme-labeled conjugates
form immune complexes with sample analyte and the other assay-specific reagents.
When substrate is added to the washed particles it reacts with the alkaline phosphatase
present in the immune complexes, resulting in chemiluminescence.
A luminometer measures the light emitted from the chemiluminescent reaction and
the system converts the measured RLUs into a test result.
Competitive Competitive binding assays, like sandwich assays, use paramagnetic particles coated
Binding with capture antibody to measure antigen in a sample. The sample is mixed with the
Assays particles, an antigen-specific antibody, and an enzyme-labeled antigen (conjugate).
The sample antigen competes with the conjugate for antibody binding sites. The
antibody and conjugate form immune complexes that bind to the particles. Magnets
separate the particle-bound immune complexes from the unbound components, and
washing removes the unbound components. When the chemiluminescent substrate is

C95318-AA
added, the measured RLUs are inversely proportional to the amount of antigen in the
sample.
0156Bc.bmp
Figure 1-1 Competitive Binding Assay Example
Sandwich Sandwich assays, like competitive binding assays, use paramagnetic particles coated
Assays with capture antibody to measure antigen in a sample. The sample is mixed with the
particles and an enzyme-labeled antibody (conjugate). The sample analyte and
conjugate form immune complexes that bind to the particles. Magnets separate the
particle-bound immune complexes from the unbound components, and washing
removes the unbound components. When the chemiluminescent substrate is added,
the measured RLUs are directly proportional to the amount of antigen in the sample.

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0158Bc.bmp
Figure 1-2 Sandwich Assay Example
Antibody Antibody detection assays measure antibody levels in a sample using paramagnetic
Detection particles coated with antigen to detect antibody in a sample. The sample is mixed with
Assays the particles, forming immune complexes. Magnets separate the particle-bound
immune complexes from the unbound antibody, and washing removes the unbound
components. An enzyme-labeled antibody (conjugate) is added. The conjugate binds
to the antibody captured on the particle to form immune complexes. Magnets separate
the bound immune complexes from the unbound antibody, and washing removes the
unbound components. When the chemiluminescent substrate is added, the measured
RLUs are directly proportional to the amount of antibody in the sample.

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0154Bc.bmp
Figure 1-3 Antibody Detection Assays
Reagent Reagent packs contain assay-specific paramagnetic particles, conjugate, and other
Packs reagents within up to five wells. Most reagent packs contain enough reagents to
perform up to 50 tests.
Reagent packs are sealed with a vapor barrier and an elastomeric coating to maintain
reagent integrity and prevent evaporation. The elastomeric coating will reseal after a
well is punctured by a reagent pipettor.
For information about reagent pack contents and storage, see the reagent instructions
for use or the reagent pack label.

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Reagent Pack Usage

The UniCel DxI system uses bar codes to identify individual reagent packs, and tracks
the number of tests that can be processed with the reagents remaining in the pack.
When you start sample processing, the system matches the requested tests to the
on-board reagent packs, and applies the following rules to determine which packs will
be used:
• Calibrated reagent packs are used before packs that are not calibrated.
• If multiple calibrated reagent packs are on board, the pack that was punctured
first is used first.
• If multiple calibrated, punctured reagent packs are on board, the pack that
expires first is used first.
• If reagent packs on board are not punctured, the pack that expires first is used
first.
• If the unpunctured pack expiration dates match, the pack that was loaded onto
the instrument first is used first.
Because the UniCel DxI system uses multiple independent reagent pipettors, up to
four reagent packs may be used simultaneously on UniCel DxI 800 systems, and up to
two reagent packs may be used simultaneously on UniCel DxI 600 systems. If multiple
test requests call for the same reagent, and multiple packs of that reagent are on-
board, the system can schedule the tests to use all pipettors assigned to the test, and
will use as many available packs as are necessary, following the above rules.
When you run quality control and calibrator samples, you can specify the reagent
pack lot number to use, if multiple lots of the reagent pack are on-board.
For information about loading reagent packs and reagent pack inventory, see
Chapter 2: Supplies in the Operator's Guide.
Assay Char- See the reagent instructions for use for each assay for information about assay
acteristics characteristics including:
• Reagent composition, storage, and handling precautions
• Analytical performance
• Sample handling
• Calibrator characteristics and calibration interval
• Calibrator and control traceability

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UniCel DxI Reference Manual 1.3: Sample Processing Theory
1.3 Sample Processing Theory

All sample processing activities in the UniCel DxI system are directed by an assay
protocol file (APF). Each test that can be run on the instrument has a unique APF,
which specifies the required quantity and dilution of sample, what reagents to use,
incubation time, and how to interpret the results.
Process During sample processing, system sensors monitor the activity of all subsystems
Monitoring involved in handling and processing samples.
The system monitors moving components to verify correct motion by comparing the
actual output of sensors with the output expected for a particular motion. In some
subsystems, multiple sensors are used, and the outputs are compared. If there is a
motion error, the sensors produce conflicting results. The system responds to motion
errors by disabling the failing subsystem or stopping the instrument, depending on the
nature and severity of the failure. One or more events are sent to the Event Log.
To detect obstructions in patient samples, an in-line pressure sensor monitors the

sample pipettor during aspiration and delivery. The system can detect whether the
output of the pressure sensor conforms to the expected pressure profile for the volume
of fluid being handled. Depending on the nature and severity of the failure, the system
may cancel a test, reject a patient sample, or stop further scheduling of tests until the
failure is corrected. Any failure sends one or more events to the Event Log. The CLT
(obstruction) flag is applied to cancelled tests and rejected samples.
Other process monitoring functions include:

• Monitoring the temperatures of the temperature-controlled areas such as
sample storage, reagent storage, and the incubator
• Monitoring the flow of wash buffer in the pipettor washing subsystems
• Monitoring the luminometer output and calculating a drift correction factor to
compensate for changes in sensitivity of the luminometer
• Monitoring the levels of consumable supplies and waste capacity

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1.3: Sample Processing Theory UniCel DxI Reference Manual
Reserve The system can be set up to draw an additional volume of sample that can be used for
Volume system generated reflex tests, LIS downloaded reflex tests, reruns, or late downloaded
LIS requests. The additional volume is called a reserve volume. When the system is
set up to draw reserve volumes, a reserve volume may be drawn from patient and QC
samples in racks that are designated for reserve volume.
Individual sample racks can be designated by rack ID for no reserve volume, or for
one of two types of reserve volume: flexible or standard.
• For samples in flexible reserve volume racks, the system calculates the
reserve volume for each sample based on the tests requested for that sample
and the reflex conditions set up for the requested tests. A flexible reserve
volume is drawn only if at least one reflex condition is defined and enabled for
at least one of the tests requested for the sample.
• For samples in standard reserve volume racks, the system always draws a
fixed volume, regardless of any other considerations.
NOTE
If the instrument is connected to a laboratory automation system (LAS), you can
also set up the system to draw flexible or standard reserve volumes from all
sample containers presented to the instrument by the LAS. This function is
independent of rack designations, and has no effect on the way samples in racks
are handled by the sample presentation unit (SPU).
You enable the reserve volume feature and set up the standard quantity of sample to
draw in the Reserve Volume Setup window. For more information, see the Setting Up
Reserve Volume topic in Section 3.7: Reflex Test Setup.
The system calculates the dead volume and overdraw and draws enough sample to
make the entire reserve volume available for tests. If the volume required for
requested tests plus the reserve volume will not fit in one RV, all of the reserve
volume is dispensed into one or more additional RVs. To calculate the volume
required in a sample container to accommodate the reserve volume, use the formula in
Section A.2: Sample Containers of the Operator's Guide.
The system draws reserve volumes only from sample containers in racks that are
designated for reserve volumes. You designate racks for reserve volumes and select
the type of reserve volume to be used for each rack in the Add/Edit Racks window.
Racks should be labeled according to their designation, with either a Flexible Reserve
or a Standard Reserve label, or, if no reserve volume is to be drawn, with a No
Reserve label. For more information, see the Setting Up Rack IDs topic in Section
2.2: System Setup.

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Unused reserve volume is discarded when the sample expires, or when sample storage
capacity is reached and more room is needed to process samples, whichever comes
first. For more information, see the Sample Expiration topic.
Onboard Assays with the onboard dilution feature provide two tests in the assay protocol file
Dilutions (APF): the parent test, which analyzes a neat (undiluted) sample, and the onboard
dilution test, which uses the same protocols as the parent test, but performs a dilution
step before processing. The dilution factor used for onboard dilution tests is fixed in
the APF.
NOTE
The parent test can be diluted manually, in which case the dilution factor for the
sample must be entered on the Test Requests screen (for more information, see
the Manual Test Requests topic in Section 3.3: Patient Test Requests of the
Operator's Guide).
See the reagent instructions for use to determine if onboard dilutions are supported for
a particular assay.
You can use the reflex test feature, with reserve volume, to automatically request
onboard dilution tests of samples that have analyte concentrations that exceed the
calibration limits of the assay.
If you expect the analyte concentration in a sample to be high, you can request
onboard dilution tests directly from the console or with a laboratory information
system (LIS).
Onboard dilution tests have names that begin with d and they use the same processes
and calibration curves as the corresponding parent tests. Onboard dilution tests
require separate setup, including ranges, units of measure, default sample type, and
decimal places. For information on setting up tests, see Chapter 3: Configuring Tests
and Results.
NOTE
Another type of onboard dilution is the special dilution. Special dilution tests
work similarly to onboard dilution tests, but only a small number of assays
support this feature. Special dilution tests have names beginning with Dil-, and
must be set up on the system by a technical support representative. For more
information, see the Special Dilution Factor topic in Section 3.3: Test Setup.

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Test Requests The system starts sample processing when it receives a test request either from the
and Sample laboratory information system (LIS), or from the system console.
Processing
Each patient test request consists of:
• Sample ID
• Rack number
• Rack position
• Sample type
• Test list
Test requests may contain additional information, including:

• Patient ID
• Sample dilution
• Priority (STAT)
• Comments
• Patient demographic information (from LIS only)
Once a test request is entered, you place the sample in a rack and load it in the sample
presentation unit (SPU) onload area. The instrument automatically moves the rack to
the sample aliquot station, scans the bar codes on the rack and sample tube, calculates
the volume of sample necessary to complete all requested tests and replicates and to
meet reserve volume requirements, and aliquots the sample into one or more reaction
vessels (RVs) to be stored in the refrigerated sample storage area. The rack is then
moved to the SPU offload area, where you can unload and reclaim any unused
quantity of sample for further testing.
Supply and Before the system runs a test, it verifies that it has sufficient quantities of the required
Calibration supplies. These include:
Verification • Assay-specific reagents
• Diluents (for onboard dilution tests)
• Wash buffer
• Substrate
• RVs
• Available capacity for disposal of liquid and solid wastes
If supplies are needed or waste containers need to be emptied, the system prompts you
to take appropriate action.

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The system also verifies that the substrate, reagent pack, and assay calibration for the
requested test are not expired. If a calibration or a time-sensitive supply is expired, the
system prompts you to replace the supply or recalibrate the assay.
NOTES
• You can run tests with expired supplies or calibrations by overriding the
conditions, but the system applies appropriate flags to the test results.
• Quality control tests run with expired supplies or calibrations will produce
results, but the results will not be added to the QC database.
The system notifies you when it cannot run a test because of certain critical
instrument conditions. The Supplies Required screen identifies the affected
instrument subsystem and the procedure that is required to correct the condition.
Select the Help button in the notification to view related information and instructions.
Sample The UniCel DxI system determines the optimal processing order using the criteria
Processing listed below. The system processes the samples with the highest priority first.
Order
Processing
Criteria
Order
1 STAT samples
2 Calibrator sample sets
3 QC samples
4 Patient samples
5 Maintenance sets
Table 1-4 Sample Processing Order Criteria
The priority is assigned when the sample is aliquoted. Sets of calibrator and
maintenance samples are prioritized after all of the samples in the set are aliquoted.
If two or more samples have the same priority, the system gives priority to the first
sample aliquoted. If a higher-priority test cannot start because a system resource (such
as a reagent pack) is not available, a lower-priority test may be processed first.

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Reagent When the system is ready to process a sample, the RV is moved by a robotic module
Addition to one of the reagent carriages, where a dedicated reagent pipettor transfers the
required volume of sample into another RV. If required by the assay protocol file
(APF), a dilution is made at this time.
The reagent pipettor transfers specified quantities of reagents into the RV. The robotic
module moves the RV to the incubator, where it remains for a period of time specified
in the APF. During the incubation period, paramagnetic particles from the reagents
bind with analyte from the sample. For more information, see Section 1.2: Assay
Technology.
In two-step assays, the RV returns to one of the reagent carriages for additional
reagents, followed by another incubation period.
Sample When the sample incubation is complete, the RV is moved to the wash carousel to
Washing and begin final processing. As the wash carousel rotates, the RV moves through three
Reading wash stations.
In each wash station, a dispense probe adds wash buffer to the RV. Magnets then
draw the paramagnetic particles out of suspension, and pull them to the side of the
RV. Finally, an aspirate probe removes the wash buffer, along with the unbound
analyte.
After completing three wash cycles, the RV is moved to the substrate probe, which
dispenses chemiluminescent substrate into the RV.
As the RV continues to move around the wash carousel, the substrate reacts with the
enzyme-tagged analyte, producing light.
The final position on the wash carousel is the luminometer, which reads the light
output from the chemiluminescent reaction. The electrical output of the luminometer
is measured and expressed in relative light units (RLU). RLUs are used, in
conjunction with assay calibration data, to calculate the test result. For more
information, see Section 1.4: Assay Calibration Theory.
After the luminometer reading, the RV is moved to a waste chute and discarded.

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Sample After aspiration, patient and QC samples are stored on the sample wheel until the
Expiration system is ready to run tests on the samples. A sample is kept on the sample wheel for
up to three hours, after which the sample expires and is discarded. Samples are set to
expire within three hours to prevent erroneous results due to sample evaporation.
RVs containing only reserve volume may be discarded earlier than the standard three-
hour expiration time under the following conditions:
• Sixty minutes has elapsed since the last test scheduled for the sample was
completed. A new test request for the sample resets the 60-minute timer.
• The sample wheel is full and no tests are scheduled for the reserve volume
RVs. The RVs that have been on the sample wheel for the longest time are
discarded first.

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1.4: Assay Calibration Theory UniCel DxI Reference Manual
1.4 Assay Calibration Theory

Assay calibrations are used to establish values that the system uses to translate the
relative light unit (RLU) output from the luminometer into test results for patient and
quality control samples. For information about setting up calibrators, requesting
calibration tests, reviewing results, and troubleshooting problems, see Chapter 5:
Assay Calibration, in the Operator's Guide.
The UniCel DxI system supports three types of assay calibrations. The calibrations
differ in the way they calculate and report test results.
• Quantitative
• Semi-quantitative
• Qualitative
To report a test result, the system requires a current calibration for each requested test.
The number of calibrators required, the math model, and all other calibration
parameters are defined in the assay protocol file (APF) for each assay, and by the
information you enter into the system when you set up a new calibrator set.
NOTE
Whether you use calibrators or controls to calibrate an assay, the UniCel DxI
system and this documentation use the term calibrator to refer to these
components.

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UniCel DxI Reference Manual 1.4: Assay Calibration Theory
Assay The UniCel DxI system performs the following types of assay calibrations:
Calibration
Types Quantitative In general, calibrator test results provide a multi-point
calibration curve.
The system uses the calibration curve to convert a
measured response in RLUs to an analyte concentration
and then expresses the result in numerical units.
Semi-Quantitative Calibrator test results provide a multi-point calibration
curve.
The system uses the calibration curve to convert a
measured response in RLUs to an analyte concentration
and then expresses the result in numerical units.
These assays may report their quantitative result as a
qualitative interpretation, such as positive, negative, or
equivocal.
Qualitative Calibrator test results provide a cutoff value based on a
formula defined in the APF.
The system compares a test RLU value to the cutoff
value and then classifies the result as reactive or non-
reactive for the analyte.
In the case of a reactive test result, a confirmatory test
may be indicated, and automatically requested as a reflex
test. The confirmatory assay produces a result of
confirmed or not confirmed.
Table 1-5 Types of Assay Calibrations

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Quantitative To calibrate quantitative and semi-quantitative assays, calibrators with known analyte
and Semi- concentrations are tested and the instrument measures the response in RLUs. The
Quantitative UniCel DxI system derives a mathematical relationship between the measured
Calibration response and the analyte concentration. This mathematical relationship is called a
calibration curve. The shape of the curve is determined by the math model used.
Fitting Calibration Data to the Defined Math Model

The system uses one of the following calibration math models to fit assay calibration
data to a curve:
• Weighted four parameter logistic curve (4PLC)
• Weighted smoothing spline with inflection points
• Weighted smoothing spline with no inflection points
• Straight line
• Ratio
Because the precision of an assay varies at each analyte concentration, the system also
uses weight constants when fitting calibration curve data.
The calibration curve is calculated from the results of individual calibrator replicates.
As the system fits the calibration data to the math model, it tries to minimize the
distance of the individual calibrator data points from the calculated curve by adjusting
the curve parameters. If the system reaches a maximum number of tries without
calculating an acceptable curve, the calibration fails. During processing, if a single
calibrator replicate is flagged with a fatal error, the system can fit the remaining data
to a curve. If more than one replicate is flagged with a fatal error, the calibration fails.
For some assays, calibration data is screened by comparing the coefficient of variation
(%CV) of the replicates of the S0 calibrator to limits defined in the APF. If the %CVs
are outside these limits, the calibration fails.
Acceptance Criteria
For quantitative and semi-quantitative assays, the system uses the precision profile
method to determine if the calibration meets acceptance criteria. The precision profile
method consists of three steps:
1. Fitting calibration data using the math model defined in the APF for that assay.
2. Calculating predicted precision at various analyte concentrations.
3. Comparing predicted precision and the limits defined in the APF for that assay.
NOTE
Some assays have further acceptance criteria, as defined in the APF.

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UniCel DxI Reference Manual 1.4: Assay Calibration Theory
Calculating Predicted Precision

After an acceptable calibration curve is obtained, the system calculates an error band
around the curve. This calculation is based on the distance of the calibration data
points from the curve. The system uses the calibration data and the shape of the math
model to predict the precision at the analyte concentrations stated in the APF.
2 4
1 X axis - analyte concentration

2 Y axis - RLUs
3 Error band (shaded area - the width of the error band is
exaggerated for illustration purposes)
4 Response precision
5 Concentration precision
Figure 1-6 Graphical Representation of an Error Band

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Comparing Predicted Precision to Defined Limits

The system compares the calculated predicted precision to the limits defined in the
APF. If the result for any analyte concentration is outside the acceptable limits
defined by the error band, the calibration fails.
Qualitative To calibrate a qualitative assay, calibrators with known analyte reactivity are tested
Calibration and the instrument measures the response in RLUs. The calibrator set contains both a
reactive and non-reactive calibrator. A qualitative assay calibration is accepted if all
of the individual calibrator replicates and replicate means are within the limits defined
in the APF. The system uses the calibrator results to calculate the cutoff. The cutoff is
used to classify test results.
NOTES
• For some qualitative assays, three replicates are run and the results of one
replicate may be excluded when determining whether the calibration passes or
fails.
• Whether you use calibrators or controls to calibrate an assay, the UniCel DxI
system and this documentation uses the term calibrator to refer to these
components.
Qualitative Acceptance Criteria

The limits for calibration acceptance are applied to the following items:
• Each replicate of the reactive and non-reactive calibrators
• The mean of the reactive and non-reactive calibrator replicates
The APF determines the number of replicates that must be within the RLU limits for
the system to accept the assay calibration. Two or more replicates of each calibrator
must be within the acceptable limits. If the system cannot calculate the mean, or the
calculated mean fails to meet the specified criteria, the calibration fails.
For some qualitative assays, the APF defines acceptable limits for the %CV of the
RLUs obtained for replicates of each calibrator. If the %CV obtained is outside these
limits, the calibration fails. For information on how to respond to failed calibrations,
see Section 5.5: Troubleshooting Failed Calibrations in the Operator's Guide.

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UniCel DxI Reference Manual 1.5: Confirmatory Assay Theory
1.5 Confirmatory Assay Theory

For some qualitative assays, a reactive test result must be confirmed with a
confirmatory assay. The confirmatory assay may consist of multiple tests, the results
of which are evaluated together to determine whether the reactive test result is
confirmed or not confirmed.
The formula for evaluating the test results is provided in the reagent instructions for
use.
To add a layer of protection against potential erroneous test results, the UniCel DxI
system will not calculate confirmatory test results if the samples for the confirmatory
tests are not aspirated at the same time. There are two ways to order tests to satisfy
this requirement:
• Request the confirmatory tests at the same time, so that the samples for each
test are aspirated from the same sample container.
• Set up a reflex condition, with reserve volume enabled, to automatically run
the confirmatory tests if the initial test result is reactive. The reserve volume
feature must be set up so that the system aspirates enough sample to perform
the initial test, as well as the confirmatory tests. For more information, see the
Reserve Volume topic in Section 1.3: Sample Processing Theory.

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1.6: Device Calibration UniCel DxI Reference Manual
1.6 Device Calibration
Luminometer Calibration
The luminometer is calibrated in the factory against a luminous standard. Thereafter,
the UniCel DxI system adjusts the luminometer automatically at system-defined
intervals.
The system uses an on-board reference standard to maintain luminometer reading

consistency. The system calculates a drift correction factor based on the reference
standard reading and applies this factor to RLU output.
Ultrasonics Calibration
The ultrasonic transducers on the reagent pipettors are calibrated in the factory.
Bulk Supply Sensor Calibration

The bulk supply sensors for wash buffer and liquid waste are calibrated by measuring
the sensor output voltage with empty and full containers.
For more information, see the Calibrating Wash Buffer or Liquid Waste Level
Sensors topic in Section 4.5: Analog and Digital Device Diagnostics.
Pressure Sensor Calibration

Pressure sensors in the sample pipettor and in the reagent pipettors are used for
obstruction detection. The instrument calibrates the pressure sensors by drawing
volumes of wash buffer and measuring the pressure required for each draw.
For more information, see the Determining Pressure Sensor Reference Curves topic in
Section 4.5: Analog and Digital Device Diagnostics.
Substrate Drawback Calibration

After substrate is dispensed to an RV, a quantity of substrate remains in the tubing
between the substrate probe and the pump. This quantity is drawn back into the pump
to keep it at the correct operating temperature until the next dispense cycle.

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UniCel DxI Reference Manual 1.6: Device Calibration
Because of potential variations in the length and diameter of substrate tubing, the
volume of the tubing must be measured by the system whenever maintenance is
performed on the substrate probe or tubing. The measurement is performed in
conjunction with the procedure for priming the substrate line. For more information,
see the Priming the Fluidics topic in Section 4.3: Prime Fluidics.

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1.6: Device Calibration UniCel DxI Reference Manual

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UniCel DxI Reference Manual 2: System Administration
2 System Administration
2.1 System Administration Overview ................................................................ 2-3
Configure Menu ................................................................................................ 2-3
2.2 System Setup .................................................................................................. 2-6
System Setup Screen ......................................................................................... 2-6
Changing the System ID ................................................................................... 2-9
Selecting the Language ..................................................................................... 2-9
Viewing System Revisions ............................................................................. 2-10
Setting the Date and Time............................................................................... 2-10
Setting the Date and Time Formats................................................................. 2-10
Setting Up Reports .......................................................................................... 2-11
Changing the System Password ...................................................................... 2-12
2.3 Supplies Setup .............................................................................................. 2-14
Supplies Setup Window .................................................................................. 2-15
Enabling and Disabling Bulk Supplies ........................................................... 2-16
Enabling and Disabling Reagent Pipettors...................................................... 2-17
Enabling or Disabling the Automatic Discarding of Expired Packs............... 2-17
Enabling or Disabling Auto Override of All Expirations ............................... 2-18
Setting Up Rack IDs ....................................................................................... 2-18
Attaching Rack Labels .................................................................................... 2-22

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2: System Administration UniCel DxI Reference Manual
2.4 SPU Bar Code Reader Setup ...................................................................... 2-25
Bar Code Symbology Parameters ................................................................... 2-25
Setting Up the SPU Bar Code Reader............................................................. 2-28
2.5 LIS Setup......................................................................................................... 2-30
Setting Up the LIS Interface ........................................................................... 2-31
Setting the LIS Send Mode ............................................................................. 2-34
2.6 Data Management ...................................................................................... 2-35
PC Admin Screen............................................................................................ 2-37
Setting Up the Auto-Delete Feature................................................................ 2-40
Running Scheduled System Backups.............................................................. 2-41
Performing Immediate System Backups......................................................... 2-45
Replacing the Backup Tape ............................................................................2-46
Restoring System Data.................................................................................... 2-46
Running Database Maintenance...................................................................... 2-46

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UniCel DxI Reference Manual 2.1: System Administration Overview
2.1 System Administration

Overview
System administration tasks include setting up the system, setting up supplies,
backing up system data, and system management functions such as enabling or
disabling pipettors and setting up the auto-delete feature.
Your UniCel DxI system is initially configured during installation. At that time, the
Beckman Coulter technical support representative sets many parameters to customize
the system for your laboratory. Some of these parameters can be changed or fine
tuned by you as you become familiar with the system, or as your specific needs
change.
Configure Use the Configure menu to:

Menu • Display the screens and windows used for setting up the system
• Display configuration information about the system
• Display the screens and windows used for administrative tasks, such as
backing up data and shutting down the system

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2.1: System Administration Overview UniCel DxI Reference Manual
2109B.bmp
System Setup (Button) Select to display the System Setup screen. Use this screen to set the
F1 UniCel DxI system values for the date and time, language, password administration,
laboratory information, bar code reader setup, bulk supplies, rack ID, and print
options. For more information, see Section 2.2: System Setup.
Tests (Button) Select to display the Tests screen. Use this screen to enable, disable, and
F2 define tests and ranges. For more information, see Section 3.3: Test Setup.
Test Panels (Button) Select to display the Test Panels screen. Use this screen to enable, disable,
F3 and define test panels of two or more tests to be run on a sample. For more
information, see Section 3.5: Test Panel Setup.
Derived Results (Button) Select to display the Derived Results screen. Use this screen to enable,
F4 disable, and define the mathematical formulas that operate on test results to report
additional derived results. For more information, see Section 3.6: Derived Result
Setup.
Figure 2-1 Configure Menu Descriptions

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UniCel DxI Reference Manual 2.1: System Administration Overview
Reflex Tests (Button) Select to display the Reflex Tests screen. Use this screen to enable, disable,
F5 and define reflex tests, and to set up reserve volumes. For more information, see
Section 3.7: Reflex Test Setup.
LIS/LAS (Button) Select to display the LIS/LAS Setup menu with the following options:
F6
LIS F1
Select to display the LIS Setup window. Use this window to set up interface
parameters between the system and a laboratory information system (LIS). For more
information, see Section 2.5: LIS Setup.
LAS F2
Not available.
PC Admin (Button) Select to display the PC Admin screen. Use this screen to:
F7
• Back up system data and schedule backups. For more information, see Section 2.6:
Data Management.
• Configure the Auto-Delete function. For more information, see Section 2.6: Data
Management.
• Shut down the system. For more information, see Section 6.3: Shut Down and
Restart Procedures.
About DxI 800 (Button) Select to display license and Technical Support information about the
or DxI 600 UniCel DxI system.
F8
Figure 2-1 Configure Menu Descriptions (continued)

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2.2: System Setup UniCel DxI Reference Manual
2.2 System Setup

You can customize system parameters on the UniCel DxI system to fit the
requirements of your laboratory. Parameters such as date, time, date and time formats,
system ID, and language affect the way information is displayed on screens and
printed on reports. You can also set a system password to restrict access to certain
functions such as scheduling backups and deleting quality control data.
Your changes to the system parameters take effect immediately.
System Setup Use the System Setup screen to:

Screen • Set the system date and time (and how they are formatted)
• Change the system ID
• Select the language used for displayed information
• Set up the SPU bar code reader
• Set the system password
• Define supply handling parameters
• View the instrument serial number, software revisions, and hardware
revisions
• Define laboratory information and printing options for reports
• Assign rack IDs for the types of sample containers used in your laboratory
To get to the System Setup screen from the Main Menu, select Configure F8 and then
System Setup F1.

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UniCel DxI Reference Manual 2.2: System Setup
2153A.bmp
System ID (Field) Displays the system ID, which identifies the system on screens and in
windows. Edit the field to change the system ID.
For more information, see the Changing the System ID topic.
Language (List) Select the language that is appropriate for your laboratory. The information on
the screen, in the system Help, and in reports is displayed and printed in this
language.
For more information, see the Selecting the Language topic.
NOTE
Changing the language also resets the time format to the 12 hour format.
Instrument Serial (Field) Displays the serial number of the UniCel DxI instrument.
Number
The serial number is defined by Beckman Coulter at the factory and is unique for
each instrument.
Figure 2-2 System Setup Screen Descriptions

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Date Format (List) Select the system format for expressing the date on screens and reports. Date
formats indicate the order that the day, month, and year are entered and displayed.
Date formats also indicate the separator used between the day, month, and year. For
more information, see the Setting the Date and Time Formats topic.
Time Format (List) Select the system format for expressing the time on screens and reports. For
more information, see the Setting the Date and Time Formats topic.
NOTE
Changing the language resets the time format to the 12 hour format.
Date/Time Date
Settings (Field) Displays the current date.
Time
(Field) Displays the current time.
For more information, see the Setting the Date and Time topic.
System Revisions (Button) Select to display the system software and hardware revisions. For more
F1 information, see the Viewing System Revisions topic.
Bar Code Reader (Button) Select to configure the internal bar code reader to read the bar code
Setup symbologies used for samples in your laboratory. For more information, see
F2 Section 2.4: SPU Bar Code Reader Setup.
Set Workgroup (Button) Select to set the time and date for the system. For more information, see the
Date/Time Setting the Date and Time topic.
F3
NOTE
Changing the date and time may affect confirmatory tests, derived results, or
reflex tests, which function on results generated within a certain time frame.
Password Setup (Button) Select to change the system password, if you are authorized. For more
F5 information, see the Changing the System Password topic.
Supplies Setup (Button) Select to control the way the system manages on-board supplies and liquid
F6 waste. For more information, see Section 2.3: Supplies Setup.
Reports Setup (Button) Select to define information that prints on the reports, and to define which
F7 reports print automatically. For more information, see the Setting Up Reports topic.
Rack ID Setup (Button) Select to configure rack IDs for the sample container types used by your
F8 laboratory, and to enable or disable reserve volume on specific racks. For more
information, see the Setting Up Rack IDs topic in Section 2.3: Supplies Setup.
Figure 2-2 System Setup Screen Descriptions (continued)

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Changing the Use this procedure to change the system ID.

System ID
System Mode: Any Mode
1. From the System Setup screen, select the System ID field.
2. Enter the new system ID. The System ID can contain up to 40 alphanumeric
characters.
Selecting the Use this procedure to select the language used on the screens, the Help, and the
Language reports.
NOTES
• Some languages may not be immediately available on your system.
• Changing the language changes the time to the 12 hour format. If your
laboratory uses the 24 hour format, see the Setting the Date and Time Formats
topic.
1. From the System Setup screen, select the Language list to display the language
options.
2. Select the language that is appropriate for your laboratory. The screen text is
displayed in the new language.
NOTES
• If you select an unrecognizable language, contact Technical Support to help
you select the appropriate language.
• If you changed the language to or from the Chinese (Simplified) or Japanese
languages, you must configure the operating system to display and print
language-specific characters properly. For instructions, see document
Configuring MicroSoft® Windows® for the Chinese or Japanese User Interface
Languages in your System Software binder or on the Beckman Coulter
website.

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Viewing Use this procedure to view the current revisions for individual components of the
System system.
Revisions System Mode: Ready Not Ready
1. From the System Setup screen, select System Revisions F1.

The System Revisions window displays revision information for software and
hardware components of the UniCel DxI system.
2. Select OK F1 to exit the window.
Setting the Use this procedure to set the date and time.
Date and
Time NOTE
If your lab is in an area with seasonal time changes such as Daylight Savings
Time, you must reset the time to accommodate the change.
System Mode: Ready Not Ready
1. On the System Setup screen, select Set Workgroup Date/Time F3 to display the
Set Workgroup Date/Time window.
2. In the Date field, enter the current date, using the format for your system.
3. In the Time field, enter the current time, using the format for your system.
4. Select OK F1 to save and apply the changes and exit the window.
Setting the Use this procedure to set the date and time formats for the system.
Date and
Time Formats NOTE
When you enter dates and times elsewhere in the system, you must follow the
format selected on the System Setup screen.
1. On the System Setup screen, select a format that is appropriate for your
laboratory from the Date Format list.
DD is the numeric day of the month (for example, 15)
MM or MON is the numeric or abbreviated month (for example, 03 = March or

MAR = March)
YY is the numeric year (for example, 03 = 2003)
2. Select a format that is appropriate for your laboratory from the Time Format list.

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Setting Up Use this procedure to provide report header information, select automatic printing for
Reports some reports, and select the printer to use for printing reports.
1. From the System Setup screen, select Reports Setup F7 to display the Reports
Setup window.
2249B.bmp
Report Header (Fields) Enter the laboratory information to be included at the top of all reports.
Information
Auto Print (Boxes) Select the reports to be automatically printed when the associated tests are
completed or cancelled. If the Continuous Sample Report box is selected, you
can select another box to add the patient name to the report.
Printer (List) Select the printer connected to your system. If more than one printer is
available, select the one recommended by Technical Support.
Figure 2-3 Reports Setup Window Descriptions

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2. To set up report header information, enter the general information for your lab in
the report header information fields. You can enter up to 56 alphanumeric
characters in each field except the Telephone field, which is limited to 30
characters.
3. Select the reports that you want to print automatically:

• Sample Report for STAT Samples - The report is printed when all tests on
the STAT sample are completed, or when tests are cancelled. For more
information, see Section 4.5: Test Result Reports in the Operator's Guide.
• Continuous Sample Report - The report is printed when there are enough
results to fill a page, or when all available samples are processed. For more
information, see Section 4.5: Test Result Reports in the Operator's Guide.
• Calibration Report - The Calibration Data Report is printed when a
calibration is completed or cancelled. For more information, see the Printing a
Calibration Data Report topic in Section 5.4: Reviewing Calibration Data in
the Operator's Guide.
4. Select the printer for your system, as instructed by Technical Support.
5. Select OK F1 to save and apply the changes and exit the window. All changes
take effect immediately.
Changing the If your laboratory has authorized you to do so, use this procedure to change the
System system password.
Password
NOTES
• The password is case-sensitive.
• To keep the password private, asterisks are displayed in the field as you enter
the password.
• You need the system password to use this feature. If you do not know the
password, contact your lab supervisor.
The following functions are secured by password:

• Deleting test result data (for more information, see Section 4.4: Managing
Test Results in the Operator's Guide)
• Deleting a point from quality control data (for more information, see
Section 6.4: Reviewing Quality Control Charts and Data in the Operator's
Guide)
• Deleting a quality control lot (for more information, see Section 6.2: Setting
Up Quality Controls in the Operator's Guide)

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• Deleting a calibrator lot (for more information, see Section 5.2: Setting Up
Calibrators in the Operator's Guide)
• Auto Delete setup and Database Maintenance (for more information, see
Section 2.6: Data Management)
• Shutting down the instrument (for more information, see Section 6.3: Shut
Down and Restart Procedures)
• Restarting the PC, depending on the version of your PC (for more
information, see Section 6.3: Shut Down and Restart Procedures)
• Changing the system password
• Changing the LIS send mode (for more information, see Section 2.5: LIS
Setup)
• Performing PC backup functions (for more information, see Section 2.6: Data
Management)
1. From the System Setup screen, select Password Setup F5 to display the
Password Setup window.
2. In the Current Password field, enter the current password.
NOTES
• The default password is Access2Admin.
• If you do not know the current password, contact the laboratory supervisor.
• If you cannot remember or find the current password, contact Technical
Support.
3. In the New Password field, enter a new password.
4. In the Confirm New Password field, enter the new password again.

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2.3: Supplies Setup UniCel DxI Reference Manual
2.3 Supplies Setup

For maximum throughput, the UniCel DxI instrument operates with two substrate
bottles, two bulk wash buffer containers, and a liquid waste drain or two on-board
liquid waste containers. You can replace one container while the instrument uses the
other to continue processing. If one container becomes unusable or is suspected of a
failure, it can be disabled on the Supplies Setup window. The system can operate
using the remaining container. However, processing will stop when you change that
container.
NOTE
The standard DxI system installation includes directing the liquid waste to an
external floor drain. Alternatively, Beckman Coulter can install a liquid waste
drawer holding two internal bulk liquid waste containers. As site conditions vary,
Beckman Coulter requires that you consult with Technical Support to determine
which liquid waste management solution is best for your laboratory.
The UniCel DxI 800 instrument has four reagent pipettors which can operate
simultaneously to process up to four tests at once. The UniCel DxI 600 instrument has
two reagent pipettors which can operate simultaneously to process up to two tests at
once. If a reagent pipettor is suspected of a failure, you can disable it on the Supplies
Setup window.
You can also set up the system to automatically discard expired reagent packs and
automatically override expired supply conditions.

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UniCel DxI Reference Manual 2.3: Supplies Setup
Supplies Use the Supplies Setup window to:

Setup Window • Enable or disable individual bulk supplies
• Enable or disable individual reagent pipettors
• Enable or disable the automatic discarding of expired reagent packs
• Enable or disable the auto override feature for expired supplies
2158B.bmp
Reagent Pipettor (Boxes) Select to enable, or clear to disable, each of the reagent pipettors. You can
disable up to three pipettors on the UniCel DxI 800 instrument, or one pipettor on
the UniCel DxI 600 instrument. The current status of each pipettor is displayed in
parentheses. A pipettor may be set to Enabled, but have a status of Disabled when
there is a technical problem with the pipettor. For more information, see the
Enabling and Disabling Reagent Pipettors topic.
Pack Expirations (Box) Select to enable, or clear to disable, the automatic discarding of expired
reagent packs. This setting has priority over the setting in the All Expirations
section of the window. For more information, see the Enabling or Disabling the
Automatic Discarding of Expired Packs topic.
Figure 2-4 Supplies Setup Window Descriptions

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All Expirations (Box) Select to enable, or clear to disable, automatic overriding of expired
conditions, such as expired curves, reagent packs, and substrate. The setting in the
Pack Expirations section of the window has priority over this setting. For more
information, see the Enabling or Disabling Auto Override of All Expirations topic.
Substrate (Boxes) Select to enable, or clear to disable, the substrate bottle that is not in use.
The bottle in use is labeled In Use, and the box for that bottle is not available.
Wash Buffer (Boxes) Select to enable, or clear to disable, the bulk wash buffer container that is
not in use. The container in use is labeled In Use, and the box for that container is
not available.
Liquid Waste (Boxes) To use the internal bulk liquid waste containers, select the Use Internal
Containers box. If the liquid waste drain kit is installed, clear the Use Internal
Containers box.
To enable the bulk liquid waste container that is not in use, select the box for that
container. Clear the box to disable the container. The container in use is labeled In
Use, and the box for that container is not available. If the Use Internal Containers
box is clear, you cannot select containers.
Figure 2-4 Supplies Setup Window Descriptions (continued)
Enabling and Use this procedure to enable or disable a substrate bottle, a bulk wash buffer
Disabling Bulk container, or a bulk liquid waste container. You can also use this procedure to disable
Supplies the internal bulk liquid waste containers in order to use the liquid waste drain kit.
1. From the System Setup screen, select Supplies Setup F6 to display the Supplies
Setup window.
2. Select a box to enable the supply container, or clear a box to disable the container.
NOTES
• For each supply, only one container can be disabled.
• Supplies labeled In Use cannot be disabled.
• If you disable the Use Internal Containers box, the other liquid waste
settings are not available.

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Enabling and If a reagent pipettor becomes inoperable or is suspected of a failure, it can be disabled
Disabling and the system can continue processing patient and QC tests with the remaining
Reagent enabled pipettors. Use this procedure to enable or disable reagent pipettors.
Pipettors
1. From the Configure menu, select System Setup F1 to display the System Setup
screen.
2. Select Supplies Setup F6 to display the Supplies Setup window.
3. Select the box for each reagent pipettor you intend to enable, or clear the box to
disable a pipettor.
NOTES
• At least one pipettor must be enabled to operate the system.
• If a pipettor assigned to a requested test is disabled, the condition is listed on
the Supplies Required screen and a message is sent to the Event Log.
• If you disable a pipettor for servicing, reconfigure all tests assigned to the
disabled pipettor, and all QC tests designated for that pipettor. For more
information, see the Assigning Pipettors to Tests topic in Section 3.3: Test
Setup. Also see Section 6.2: Setting Up Quality Controls in the Operator's
Guide.
• When you enable a pipettor that was previously disabled, you may need to
initialize the system before the pipettor can be used again.
4. Select OK F1 to save and apply your changes and exit the Supplies Setup
window.
Enabling or Use this procedure to configure the instrument to keep or discard expired reagent
Disabling the packs.
Automatic
Discarding of NOTE
Expired Packs When this option is enabled, expired packs are discarded regardless of whether
the Auto Override box is selected. For more information, see the Enabling or
Disabling Auto Override of All Expirations topic.
Setup window.
2. In the Pack Expirations section of the window, select the Discard Expired Packs
box, or clear the box to keep expired packs on board the instrument.

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Enabling or Use this procedure to automatically override conditions which normally would result
Disabling in a supply wait condition:
Auto Override
• Reagent calibration curve expired
of All
Expirations • No reagent calibration curve
• Reagent pack expired
• Substrate expired
Auto override has the same effect as selecting Override F8 on the Supplies Required
screen. For more information, see Section 2.1: Supply and Supply Conditions
Overview of the Operator's Guide.
NOTES
• When conditions are detected and overridden, test results are flagged for those
conditions.
• If you override a reagent pack that is not calibrated (no curve), the sample is
processed but the results are not reported.
• Enabling Auto Override of all expirations allows for the use of reagent packs
that expire while they are onboard the system. Enabling Auto Override does
not allow for the use of packs that expire while they are offboard the system,
even if another pack from the same lot is onboard when the expiration occurs.
• If the Discard Expired Packs box is selected, that setting has priority over the
Auto Override setting. For more information, see the Enabling or Disabling
the Automatic Discarding of Expired Packs topic.
Setup window.
2. In the All Expirations section of the window, select the Auto Override box to
automatically override expirations, or clear the box to disable this function.
Setting Up You can change the association of rack IDs and ranges of rack IDs with the types of
Rack IDs sample containers used in your laboratory. Rack ID setup functions include:
• Adding rack IDs
• Editing rack IDs
• Deleting rack IDs

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• Designating racks for reserve volumes (for more information, see the Setting
Up Reserve Volume topic in Section 3.7: Reflex Test Setup; also see the
Reserve Volume topic in Section 1.3: Sample Processing Theory)
CAUTIONS
• All rack ID changes in the setup must be accompanied by corresponding
changes to the container type labels on the racks. Failure to correctly label
racks can result in damage to the instrument and loss of samples due to
placement of incorrect container types in the rack. For more information,
see the Attaching Rack Labels topic.
• Do not change the rack ID setup while there are racks in the SPU. Either
wait for the racks to be processed, or remove them from the SPU.
Adding and Editing Rack IDs

Use this procedure to add or edit a rack ID or a range of rack IDs.
1. From the System Setup screen, select Rack ID F8 to display the Rack ID window.
2160C.bmp
Rack ID/Range (Column) Displays a rack ID or a range of rack IDs that are associated with a
particular container type.
Container Type (Column) Displays the container type that is associated with a particular rack ID or
range of rack IDs.
Draw Reserve (Column) Displays the reserve volume setting for a rack ID or range of rack IDs.
Volume Possible values are Standard, Flexible, and No Reserve.
Add Racks (Button) Select to add a rack ID or a range of rack IDs.
F2
Figure 2-5 Rack ID Window Descriptions

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Edit Racks (Button) Select to edit the highlighted rack ID or range of rack IDs.
F3
Delete Racks (Button) Select to delete the highlighted rack ID or range of rack IDs.
F4
Figure 2-5 Rack ID Window Descriptions (continued)
2. Add a new rack, or edit an existing one:

• To add a new rack, select Add Racks F2 to display the Add/Edit Racks
window.
• To edit an existing rack, select Edit Racks F3 to display the Add/Edit Racks
window.
2165C.bmp
Rack ID (Option and field) Select the option to enter a single rack
ID in the associated field. The field is not available if the
option is not selected.
Figure 2-6 Add/Edit Racks Window Descriptions

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Range of IDs (Option and fields) Select the option to enter a range of
rack IDs in the associated From: and To: fields. The
fields are not available if the option is not selected.
Container Type (List) Select the container type to associate with the
selected rack ID or range of rack IDs.
Draw Reserve (Box and options) Select to designate the selected rack
Volume ID or range of rack IDs for reserve volume. Reserve
volume is drawn from patient and QC samples in
designated racks. When the Draw Reserve Volume box
is selected, options are available to select flexible reserve
volume or standard reserve volume.
• Flexible Reserve (Option): Select to use flexible
reserve volume for the selected rack ID or range of
rack IDs
• Standard Reserve (Option): Select to use standard
reserve volume for the selected rack ID or range of
rack IDs
Figure 2-6 Add/Edit Racks Window Descriptions (continued)
3. Select a rack ID option:

• To enter a single rack ID, select the Rack ID option.
• To enter a range of rack IDs, select the Range of IDs option.
4. Enter a rack ID or range of rack IDs in the fields below the selected option.
5. Select the type of sample container that can be placed in one of these racks from
the Container Type list.
6. Select the Draw Reserve Volume box if a reserve volume is to be drawn from
patient and QC samples in one of these racks.
7. If you selected the Draw Reserve Volume box in step 6, select the type of reserve
volume to use for the selected rack ID or range of rack IDs:
• To use flexible reserve volume, select the Flexible Reserve option.
• To use standard reserve volume, select the Standard Reserve option.
9. Select OK F1 to exit the Rack ID window.

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Deleting Rack IDs

Use this procedure to delete a rack ID or a range of rack IDs.
1. Select the rack ID or range of rack IDs to delete.
2. Select Delete Racks F4.
3. Select OK F1 to confirm the deletion and apply changes. All changes take effect
immediately.
4. Select OK F1 to exit the Rack ID window.
Attaching There are four types of sample rack labels.

Rack Labels • Rack bar code label - The identification label scanned by the SPU bar code
reader.
• Container type label - An illustration of the accepted container type.
• Reserve Volume labels - Three labels to identify what type of reserve volume
is designated for the rack (No Reserve, Standard Reserve, or Flexible
Reserve).
• Rack ID label - The unique identification number that distinguishes one rack
from another, and designates the accepted sample container type. The number
on the rack ID label is the same number that is encoded on the bar code label.
Both labels are supplied together, on the same sheet.
NOTE
You can configure the types of sample containers that are accepted for a range of
rack IDs. For more information, see the Setting Up Rack IDs topic.
Use these procedures to attach labels to a rack.
Attaching the Rack Bar Code Label

1. Locate the rack indentation on the body of the rack. The indentation is to the right
of sample container position 3.
2. Lay the rack on a table so the indentation faces up.
3. With the bar code nearest the top of the rack and the corresponding rack ID
number underneath it, align the bar code label with the indentation and attach the
label securely to the rack. To be sure the rack bar code is scanned correctly, leave
no more than a 0-1 mm gap at the bottom of the label.

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Attaching the Container Type Label

1. Rotate the rack so the side closest to sample container position 1 faces you.
2. Align the container type label so it is centered with the side and near the bottom
of the rack, and attach the label securely to the rack.
1 4
3
2
3
13
x 1
51
0
4
7
R
6
13x
75
5
2149B.eps
1 Sample container position 1

2 Sample container position 3
3 Rack indentation
4 Rack bar code label
5 Container type label
6 Reserve Volume label
7 Rack ID label
Figure 2-7 Sample Rack Label Positions

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Attaching the Reserve Volume Label

Attach the Reserve Volume label that corresponds to the type of reserve volume you
have designated for the rack (see Table 2-8).
Flexible Reserve Standard Reserve No Reserve
2342A.eps 2342A.eps 2341A.eps
Table 2-8 Reserve Volume Labels
1. Position the rack so the container type label faces you.
2. Align the Reserve Volume label so it is centered above the container type label
and attach the label securely to the rack.
Attaching the Rack ID Label

1. Rotate the rack so the side closest to sample container position 1 faces you.
2. Align the rack ID label so it is centered with the shoulder adjacent to sample
position 1, and attach the label securely to the rack.

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UniCel DxI Reference Manual 2.4: SPU Bar Code Reader Setup
2.4 SPU Bar Code Reader Setup

The SPU bar code reader scans printed bar code labels on sample containers and
racks, and sends the information to the system software. The SPU bar code reader can
read the following bar code symbologies:
• Interleaved 2 of 5
• CODABAR
• CODE 39
• CODE 93
• CODE 128
Bar Code Some bar code symbologies include parameters that can be configured to improve
Symbology data integrity. If you are not sure which parameters to configure, contact the supplier
Parameters of your printed sample bar code labels or consult the documentation provided by the
manufacturer of your sample bar code printer.
NOTE
The bar code parameters configured for the SPU bar code reader must match the
parameters of your sample bar code labels. If, after consulting your bar code
printer documentation, you cannot identify which bar code or bar code
parameters you need to configure, contact Technical Support.
Available Parameters
Symbology Check Digit Send Send Number of

On Check Digit Start/Stop Characters to
Characters Send
Interleaved Available Available Not available 4-15*

2 of 5
Table 2-9 Available Bar Code Parameters

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2.4: SPU Bar Code Reader Setup UniCel DxI Reference Manual
Available Parameters
Symbology Check Digit Send Send Number of

On Check Digit Start/Stop Characters to
Characters Send
CODABAR Available Available Available Not specified

CODE 39 Available Available Not available Not specified
CODE 93 All parameters are factory-set and cannot be changed
CODE 128 All parameters are factory-set and cannot be changed
Table 2-9 Available Bar Code Parameters

* For Interleaved 2 of 5, the bar code must be an even number of characters. If check digit is
enabled, but sending check digit is not, an odd number of characters are required in the
Characters field, from 5 to 15. Otherwise, an even number of characters are required in the
Characters field, from 4 to 14.
Check Digit On
Some bar code symbologies include an optional check digit in the bar code (see Table
2-9). The check digit is calculated by applying a standard formula to the data as it is
encoded. When the bar code reader scans the bar code, it applies the same formula to
the data that it reads, and compares the result with the check digit in the bar code. The
data is transmitted to the system software only if the scanned and calculated check
digits match.
WARNING
Beckman Coulter strongly recommends using the check digit with the less
accurate symbologies, such as Interleaved 2 of 5 and CODABAR.
Send Check Digit

When a check digit is included in a bar code symbology, and the bar code reader is set
up to calculate and read the check digit (Check Digit On), the bar code reader can
send that digit to the system software with the data, or it can withhold the digit. If the
check digit is sent, it is also displayed on screens and reports as part of the Sample ID.
Also see the Check Digit On topic.
NOTE
Withholding the check digit does not disable error checking. It only prevents the
check digit from being sent to the system as part of the sample ID.

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Send Start/Stop Characters

Some bar code symbologies include characters at the beginning and end of the bar
code to indicate where the bar code information starts and stops (see Table 2-9). The
bar code reader can send these characters to the system software, or it can withhold
them. If the start and stop characters are sent, they are also displayed on screens and in
reports as part of the Sample ID.
Number of Characters to Send

The Interleaved 2 of 5 symbology requires that bar codes always have the same
number of characters, and that this must be an even number, including the optional
check digit, if used. The bar code reader must be set up to read and send the correct
number of characters. For more information, see the Setting Up the SPU Bar Code
Reader topic.
The number of characters that can be sent falls into one of three ranges, depending on
how the check digit is used. For the allowable ranges, see Table 2-10.
Check Digit Send Check

On Digit Number of Characters to Send
No No 4-14 (even number)
Yes No 5-15 (odd number)
Yes Yes 4-14 (even number, including check digit)
Table 2-10 Number of Characters to Send (Interleaved 2 of 5 Symbology)
For more information about the bar code readers, see the Bar Code Hardware
Performance Properties and Sample Bar Code Label Specifications topics in Section
A.2: Performance Characteristics.

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2.4: SPU Bar Code Reader Setup UniCel DxI Reference Manual
Setting Up the Use this procedure to configure the SPU bar code reader. You can configure the bar
SPU Bar Code code reader to read more than one symbology.
Reader
CAUTION
Do not change the bar code reader setup while there are racks in the SPU. Either
wait for the racks to be processed, or remove them from the SPU.
System Mode: Ready
1. From the System Setup screen, select Bar Code Reader Setup F2 to display the
Bar Code Reader Setup window.
2154A.bmp
Read Sample IDs (Box) Select to set up the bar code reader to read bar codes on sample containers.
Clear the box to stop reading bar codes on sample containers.
Interleaved 2 of 5 Check Digit On
(Box) Select to read, calculate, and compare the check digit to improve data integrity.
For more information, see the Check Digit On topic.
Send Check Digit
(Box) Select to send the check digit to the system software as part of the sample ID.
This box is available only when the Check Digit On box is selected. For more
information, see the Send Check Digit topic.
Characters
(Field) Enter the number of characters to send to the system software. For more
information, see the Number of Characters to Send topic.
Figure 2-11 Bar Code Reader Setup Window Descriptions

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CODABAR Check Digit On

Send Check Digit
Send Start/Stop
(Box) Select to send start/stop characters to the system software as part of the sample
ID. For more information, see the Send Start/Stop Characters topic.
CODE 39 Check Digit On
Send Check Digit
Figure 2-11 Bar Code Reader Setup Window Descriptions (continued)
2. To configure the bar code reader to scan the bar codes on the sample containers,
select the Read Sample IDs box.
NOTE
This option is selected by default. Leave the bar code reader enabled unless it is
malfunctioning. If it is malfunctioning, contact Technical Support immediately.
3. To enable error checking, select the Check Digit On box for the symbologies
used in your laboratory. For more information, see the Check Digit On topic.
4. To send the check digit to the system software as part of the sample ID, select the
Send Check Digit box for the symbologies used in your laboratory. For more
5. To send the start and stop characters to the system software as part of the sample
ID when reading CODABAR bar codes, select the Send Start/Stop box. For
more information, see the Send Start/Stop Characters topic.
6. Select OK F1 to save and apply the changes.

A progress message is displayed. Another message is displayed when the
configuration is complete.

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2.5: LIS Setup UniCel DxI Reference Manual
2.5 LIS Setup

The Laboratory Information System (LIS) interface allows the UniCel DxI system to
communicate with an LIS using the ASTM E1394-97 and ASTM E1381-95 standard
protocols. Your LIS vendor configures the LIS to communicate with the UniCel DxI
system using these standards and the LIS Vendor Information CD.
When the LIS interface is on, test requests can be entered at the LIS and downloaded
to the UniCel DxI system for processing. Received test requests are stored in the LIS
workpool until samples are loaded and the corresponding sample IDs are scanned by
the SPU bar code reader. Then the associated LIS test requests are scheduled and
displayed on the Sample Manager screen.
When host query is enabled, and a sample is loaded for which no test requests can be
found in the LIS workpool, the instrument can send a query to the LIS. The LIS must
respond with a test request within the time period specified in the LIS setup, or the
sample is rejected by the instrument.
After sample processing, patient sample results with associated flags can be
automatically sent to the LIS, or each result can be reviewed and then manually
transmitted to the LIS from the Test Results screen. To set up the UniCel DxI system
to send only results that are within certain ranges, see Section 3.4: Ranges Setup.
Quality control and calibration tests cannot be requested from the LIS, but quality
control test results can be transmitted to the LIS. Calibration results cannot be
transmitted to the LIS.
For more information about sample processing and the LIS, see Section 3.2: LIS
Requests and Work Pending in the Operator's Guide.

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UniCel DxI Reference Manual 2.5: LIS Setup
Setting Up the Use this procedure to set up the LIS interface to communicate with the LIS.
LIS Interface
1. From the Configure menu, select LIS/LAS F6 and then LIS F1 to display the LIS
Setup window.
2155A.bmp
Local LIS Interface (List) Select On to enable the LIS interface for this instrument. The Global LIS
Interface setting must also be On.
Select Off to disable the LIS interface for this instrument.

Auto Send to LIS (List) Select which results to send automatically to the LIS.
Figure 2-12 LIS Setup Window Descriptions

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Host Query On (Box) Select to enable the system to query the LIS for test requests. For more
information, see the Querying the LIS for Test Requests topic in Section 3.2: LIS
Requests and Work Pending of the Operator's Guide.
Clear to disable host query.
LIS Communication (Box) Enter the number of seconds that the system will wait for the result of a host
Wait Time Per query for each sample container.
Sample Container
(9-90 Seconds)
Port (Field) Displays the name of the port used to connect the instrument to the LIS.
Baud Rate (List) Select the data rate for communication with the LIS. This setting is made by
the technical support representative when your system is installed.
Data Bits (Field) Displays the number of data bits to be used for each transmitted character.
Global LIS Interface (List) Select On to enable the LIS interface. Both this setting and the local LIS
interface must be enabled to communicate with the LIS. This setting is made by the
technical support representative when your system is installed.
LIS Send Mode (List) Select By Test to send individual test results as they are calculated. Select
By Sample Container to send all results for one sample container in a single
message.
NOTES
• You need the system password to use this feature.
• Reflex test results may be sent separately when By Sample Container is
selected.
Parity (Field) Displays the parity setting for each transmitted character.
Stop Bits (Field) Displays the number of stop bits for each transmitted character.
Start Bits (Field) Displays the number of start bits for each transmitted character.
Figure 2-12 LIS Setup Window Descriptions (continued)
2. From the Local LIS Interface list, select On to enable the LIS interface.
3. From the Global LIS Interface list, select On to enable the system to
communicate with the LIS.
NOTE
Select Offline to temporarily suspend the transmission of data to the LIS
interface. When the LIS Interface is offline, the system stores any data waiting to
be sent to the LIS until you set the Global LIS Interface field to On.

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UniCel DxI Reference Manual 2.5: LIS Setup
4. In the Auto Send to LIS field, select an item from the list.
• Select Send All Results to automatically send all patient test results to the
LIS as soon as results are calculated. Calibration results are not sent to the
LIS.
• Select Send Only Auto-Verified Results to automatically send only results
verified according to LIS ranges to the LIS. For information about setting up
verification criteria, see Section 3.4: Ranges Setup.
• Select Off to prevent automatic sending of results to the LIS. You can send
results to the LIS manually when automatic sending is disabled. For more
information, see Section 4.4: Managing Test Results in the Operator's Guide.
5. To enable the system to query the LIS for specific test requests:
a. Select the Host Query On box.
b. In the LIS Communication Wait Time Per Sample Container (9-90
Seconds) field, enter the number of seconds (from 9-90) for the LIS to send a
test request after a host query is sent from the instrument.
6. Set the LIS send mode. For more information, see the Setting the LIS Send Mode
topic.
NOTE
You need the system password to use this feature.
7. Select OK F1 to save and apply the changes and exit the LIS Setup window.

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Setting the LIS Test results can be sent to the LIS either after each test is completed, or in a single
Send Mode message after all test results for a sample container are completed.
Use this procedure to set the LIS send mode.
NOTE
You need the system password to use this feature. If you do not know the
password, contact your lab supervisor. For more information about passwords,
see the Changing the System Password topic in Section 2.2: System Setup.
1. From the Configure menu, select LIS/LAS F6 and then LIS F1 to display the LIS
Setup window.
2. Confirm that the Global LIS Interface is off. If it is on, perform the following
steps:
a. In the Global LIS Interface field, select Off.
b. Select OK F1 to save and apply the changes and exit the LIS Setup window.
c. Return to the LIS Setup window and continue with step 3.
3. In the LIS Send Mode field, either select By Test to send test results after each
test is completed, or select By Sample Container to send test results in a single
message after all tests for one sample container are completed.
NOTE
Reflex test results may be sent separately when By Sample Container is
selected.
4. Enter the system password, then select OK F1.
5. Select OK F1 to save and apply the changes and exit the LIS Setup window.
6. To turn the Global LIS Interface on, perform the following steps:
a. Return to the LIS Setup window.
b. In the Global LIS Interface field, select On.
c. Select OK F1 to save and apply the changes and exit the LIS Setup window.

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UniCel DxI Reference Manual 2.6: Data Management
2.6 Data Management

Data management on the UniCel DxI system includes database size management and
periodic system backups.
Database Size Management

When a database becomes very large, filtering and sorting functions take longer to
perform. LIS downloads can be delayed so long that samples are released to Work
Pending, and must be loaded again. Without management, the database would fill the
hard disk.
NOTE
If data management efforts do not improve system performance to your
satisfaction, contact Technical Support for assistance.
The system uses the following features to manage the size of the database: auto-trim
and auto-delete.
The auto-trim feature deletes the oldest patient and QC sample data when the number
of samples exceeds internal limits. As tests are completed, the oldest samples are
deleted from the database to make room for new samples. Auto-trim is enabled by
default and cannot be configured in the user interface.
The auto-delete feature as configured by the user deletes data after a certain number
of days. Auto-delete can be enabled and configured separately for patient samples,
QC samples, and expired offboard reagent pack data.
The auto-delete feature for calibration data deletes unusable calibrations after 365
days. Unusable calibration data no longer has an Active, Previous Active, or Last Run
status. For more information on calibration status, see Section 5.4: Reviewing
Calibration Data in the Operator’s Guide. Auto-delete for calibration data is enabled
by default and cannot be configured in the user interface.
Auto-delete and auto-trim operations occur at the following times:

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2.6: Data Management UniCel DxI Reference Manual
• 10 minutes after the user interface software is started.

• Immediately, any time the auto-delete feature is reconfigured.
• Automatically, once per day, at a time that initially is set by the technical
support representative during installation.
NOTE
After you set up scheduled backups, the auto-delete and auto-trim operations
occur daily, one hour after the scheduled backup time (regardless of whether
the backups are scheduled to occur daily or weekly).
System Backups
Data stored on electronic storage media is susceptible to corruption and loss due to
accidents, power failure, or equipment failure. To prevent such catastrophic losses,
back up your system regularly. Backing up the system saves system related files,
including test results data, configuration settings, and utilities.
System backup data is stored on either of the following media:
• A tape, using the tape drive of the external computer. The tape can hold a
maximum of 20 GB of data
• A flash drive plugged into the USB port of the external computer. The USB
flash drive can hold a maximum of 8 GB of data.
Either medium provides sufficient storage capacity for complete system backups.
When the system stores data on the USB flash drive, the system stores the same
backup data on the disk drive of the external computer, which maintains several of the
most recent backups. This provides redundancy of backups and enables quick
restoration of data in most cases.
You can schedule system backups to run automatically, or you can manually back up
the system. Determining the appropriate backup schedule is a matter of laboratory
preference. You establish an initial backup schedule with the technical support
representative when your system is installed.
NOTES
• To limit the amount of data that is lost in the event of catastrophic failure,
Beckman Coulter recommends that you back up your data daily.
• When you back up your data, the current data overwrites the previous contents
of the tape or USB flash drive.
• If using tape, keep at least three backup tapes. Cycle the tapes to be sure that at
least three backup cycles are available. Store the backup tapes in a safe place.

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PC Admin Use the PC Admin Screen to:

Screen • Set up the auto-delete function to manage the size of the database
• Schedule automatic system backups
• Perform immediate system backups
• Shut down the instrument or the external computer
To get to the PC Admin screen from the Main Menu, select Configure F8, then PC
Admin F7.
2159D.bmp
Last Backup Status

(Field) Displays the status of the last system backup.
Began
(Field) Displays the date and time that the last system backup began.
Completed
(Field) Displays the date and time that the last system backup was completed.
Figure 2-13 PC Admin Screen Descriptions

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Next Backup Status

(Field) Displays whether another automatic backup is scheduled.
Begin
(Field) Displays the date and time that the next system backup is scheduled to begin.
Frequency
(Field) Displays how frequently the automatic system backups are scheduled to occur.
Scheduled (Button) Select to display the Scheduled Backup window. Use the window to schedule
Backup system backups to occur weekly or daily at the date and time you select. For more
F1 information, see the Running Scheduled System Backups topic.
NOTE
Immediate (Button) Select to run an immediate system backup. For more information, see the
Backup Performing Immediate System Backups topic.
F2
NOTE
Eject Tape (Button) Select to remove the backup tape from the instrument.
F3
NOTE
Do not select this button if your system uses a USB flash drive for backups.
Restore (Button) Select to restore backed up data only as instructed by Technical Support.
F4
Auto-Delete (Button) Select to display the Auto-Delete Setup window. The auto-delete function
Setup deletes patient and QC sample data after a specified number of days. For more
F5 information, see the Setting Up the Auto-Delete Feature topic.
NOTE
Reset Verbosity (Button) Select to reset the amount of information recorded in internal log files to the
F6 default after receiving an Event Log message saying that verbosity levels are set too
high. Use this button only as directed by Technical Support.
Database (Button) Select to run database maintenance and optimize database performance. Use
Maintenance this button only as directed by Technical Support.
F7
NOTE
Figure 2-13 PC Admin Screen Descriptions (continued)

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System Admin (Button) Select to display a menu of system administration functions.

F8
WARNING
Do not turn off power to the instrument after using Shut Down PC F1 to shut
down the instrument software. Doing so can corrupt the disk drive in the
instrument. If you intend to turn off power to the instrument, select Shut Down
Instrument F2 instead.
Shut Down PC F1
Select to shut down the external computer and, optionally, to shut down the instrument
software. For more information, see the Shutting Down the PC topic in Section 6.3:
Shut Down and Restart Procedures.
Shut Down Instrument F2
Select to shut down the instrument. For more information, see the Shutting Down the
Instrument topic in Section 6.3: Shut Down and Restart Procedures.
NOTE
Instrument Service F3
Select to perform service functions. Use this function only as directed by your technical
support representative.
NOTE
Remote Management F4
Select to set up instrument control sharing. Use this function only as directed by your
technical support representative.
NOTE
Integrated System Setup F5

Select to set up a UniCel DxC Synchron Access Clinical Systems Integrated
Workstation. Use this function only as directed by your technical support
representative.
NOTE
Figure 2-13 PC Admin Screen Descriptions (continued)

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Setting Up the Use this procedure to set up the auto-delete database size management feature.
Auto-Delete
Feature NOTES
• The auto-delete feature is activated immediately after completing this setup
procedure.
password, contact your lab supervisor. For more information about
passwords, see the Changing the System Password topic in Section 2.2:
System Setup.
1. From the PC Admin screen, select Auto-Delete Setup F5.
2299A.bmp
Automatically (Box and field) To automatically delete patient samples from the database after a
delete patient certain number of days, select the box and enter the number of days in the Days field.
samples after: Clear the box to discontinue automatically deleting patient samples.
Automatically (Box and field) To automatically delete QC samples from the database after a certain
delete QC number of days, select the box and enter the number of days in the Days field. Clear the
samples after: box to discontinue automatically deleting QC samples.
Automatically (Box) Select to automatically delete expired off-board reagent packs from the database
delete expired after 30 days. Clear to discontinue automatically deleting expired off-board reagent
off-board packs.
reagent packs
after 30 days
Figure 2-14 Auto-Delete Setup Window Descriptions

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3. In the Auto-Delete Setup window, select the boxes for the types of database
deletions you intend to automate. You can automatically delete patient samples,
QC samples, and expired off-board reagent packs.
 (Optional) To disable the auto-delete feature for a sample type, clear its box.
4. If a selected box has an associated Days field, enter the number of days to wait
before deleting samples from the database. Beckman Coulter recommends that
you select the Automatically delete patient samples after: box and enter 21 in
the Days field.
5. Select OK F1.
6. In the confirmation window, select Yes F1 to save the changes and return to the
PC Admin screen.
The changes take effect immediately, and an information event is created in the
Event Log.
Running Use this procedure to schedule and run automatic system data backups to tape or USB
Scheduled flash drive.
System
Backups NOTE
1. Skip this step if you back up to a USB flash drive. If you back up to tape, confirm
that a backup tape is loaded in the tape drive. Load a backup tape if necessary.
2. From the PC Admin screen, select Scheduled Backup F1.

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2156B.bmp
Enable Automatic (Box) Select to enable scheduled system backups. The

Backup system backups run automatically on the scheduled day
and time.
Daily Backup (Option) Select to schedule the system backup to run
every day at the time selected in the Start Time list.
Weekly Backup (Option with list) Select to schedule the system backup to
run weekly.
NOTE
When you select the Weekly Backup option, also
select a day of the week and the time of day for the
backup to run.
Start Time (List) Select a time from the list. The system backup will
run at this time.
CAUTION
Do not set the start time to 23:00. Doing so will
prevent the auto-delete and auto-trim functions from
running.
Figure 2-15 Scheduled Backup Window Descriptions
4. In the Scheduled Backup window, select the Enable Automatic Backup box.

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5. Select the Daily Backup or the Weekly Backup option to set the backup
frequency.
6. If you selected the Weekly Backup option, select the day of the week that you
want the backup to run.
7. Select the time that you want the backup to run from the Start Time list.
CAUTION
Do not set the start time to 23:00. Doing so will prevent the auto-delete and
auto-trim functions from running.
The backup will automatically run at the selected time. When the system
completes a backup, it displays a message to notify you if the backup succeeded,
failed, or was cancelled.
NOTE
If there are pending tests, or if the system is in the Running or Paused mode, the
backup is postponed for five minutes. After 100 postponements (approximately
eight hours), the scheduled backup is cancelled, and the system displays a
message.
9. If the backup failed or was cancelled, manually back up the system (see the
Performing Immediate System Backups procedure).
If the backup fails or is cancelled again, contact Technical Support.
10. If you back up to tape, replace the tape containing the successful backup with a
fresh tape for the next scheduled backup. For more information, see the
Replacing the Backup Tape topic.

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USB Flash Backups Tape Backups
Confirm that the correct tape

is in the backup tape drive
PC Admin
1. Select Enable Automatic
Scheduled Backup Backup.
2. Select Back Up Daily or
Back Up Weekly.
3. For a weekly backup,
Scheduled Backup F1 select the day of the week.
OK F1
4. Select the time of day to
run the backup.
Password
Perform immediate system

Enter your system password
Was the backup
No backup. If immediate backup
fails, contact Technical
successful?
Support.
OK F1
Yes
USB Flash Backups Tape Backups
If you are backing up to tape,

If you are backing up to a
label the tape with the date
USB flash drive, no further
and time, and store it in a
action is necessary.
safe place
Load a tape for the next

scheduled backup
2171B.wmf
Figure 2-16 Scheduling System Backups Flowchart

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Performing Use this procedure to perform an immediate system backup to tape or USB flash
Immediate drive.
System
Backups NOTE
1. Skip this step if you back up to a USB flash drive. If you back up to tape, load the
backup tape in the tape drive.
2. From the PC Admin screen, select Immediate Backup F2.
4. In the Immediate Backup window, select OK F1 to begin the backup.
NOTE
You cannot run an immediate backup while a scheduled backup is running.
5. When the backup is complete, the system displays a message to notify you if the
backup succeeded, failed, or was cancelled. Select OK F1 to close the backup
status message window.
6. If the backup failed or was cancelled, repeat this procedure. If the backup fails or
is cancelled again, contact Technical Support.
7. If you back up to tape, replace the tape containing the successful backup with a
fresh tape for the next scheduled backup. For more information, see the
Replacing the Backup Tape topic.

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Replacing the If you back up to tape, use this procedure to replace the backup tape after a successful
Backup Tape immediate or scheduled backup. If you back up to a USB flash drive, skip this
procedure.
1. From the PC Admin screen, select Eject Tape F3.

If no tape is in the drive, or a backup is in progress, the system displays an error
message.
2. Remove the tape from the tape drive on the external computer.
3. Label the tape according to laboratory policy. At a minimum, mark the tape with
the backup date and time and the system ID.
4. Store the backup tape in a safe place.
5. Place another tape in the tape drive for the next backup. Push the tape until it is
properly seated.
Restoring Contact Technical Support for instructions on how to perform this procedure.
System Data
CAUTION
Restoring system data erases critical data from your system. Use this function
only as directed by your technical support representative.
Running Contact Technical Support for assistance with performing this procedure.
Database
Maintenance

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UniCel DxI Reference Manual 3: Configuring Tests and Results
3 Configuring Tests and

Results
3.1 Configuring Tests and Results Overview ................................................... 3-3
3.2 Assay Protocol File ........................................................................................ 3-4
Updating the APF.............................................................................................. 3-4
3.3 Test Setup ........................................................................................................ 3-5
Tests Screen ...................................................................................................... 3-5
Applying Filters and Sort Orders for Tests ....................................................... 3-8
Setting Up a Test............................................................................................... 3-9
Disabling a Test .............................................................................................. 3-10
Editing Units ................................................................................................... 3-11
Setting a Gray Zone ........................................................................................ 3-13
Special Dilution Factor ................................................................................... 3-16
Assigning Pipettors to Tests............................................................................3-16
Printing the Tests Setup Report ...................................................................... 3-17
3.4 Ranges Setup ................................................................................................ 3-19
Range Windows .............................................................................................. 3-20
Setting Up Ranges........................................................................................... 3-21
Clearing a Range ............................................................................................. 3-22
Printing Ranges Reports.................................................................................. 3-23

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3: Configuring Tests and Results UniCel DxI Reference Manual
3.5 Test Panel Setup ........................................................................................... 3-25
Test Panels Screen .......................................................................................... 3-25
Applying a Test Panel Filter ........................................................................... 3-27
Adding a Test Panel ........................................................................................ 3-28
Editing a Test Panel ........................................................................................ 3-32
Deleting a Test Panel ...................................................................................... 3-33
Printing the Test Panels Setup Report............................................................. 3-33
3.6 Derived Result Setup ................................................................................... 3-35
Derived Result Operators................................................................................3-36
Derived Results Screen ................................................................................... 3-37
Adding a Derived Result................................................................................. 3-39
Editing a Derived Result ................................................................................. 3-41
Deleting a Derived Result ............................................................................... 3-42
Printing the Derived Results Setup Report ..................................................... 3-42
3.7 Reflex Test Setup .......................................................................................... 3-44
Reflex Condition Elements ............................................................................. 3-45
Reflex Condition Keywords............................................................................3-46
Reflex Condition Operators and Syntax ......................................................... 3-46
Reflex Test Condition Special Considerations ............................................... 3-48
Reflex Tests Screen......................................................................................... 3-49
Setting Up Reserve Volume............................................................................3-51
Adding a Reflex Test ...................................................................................... 3-55
Editing a Reflex Test....................................................................................... 3-57
Deleting a Reflex Test..................................................................................... 3-58
Printing the Reflex Tests Setup Report........................................................... 3-58
Enabling or Disabling All Reflex Tests .......................................................... 3-60

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UniCel DxI Reference Manual 3.1: Configuring Tests and Results Overview
3.1 Configuring Tests and

Results Overview
The UniCel DxI system provides the flexibility for your laboratory to configure which
tests to run on the instrument and how the results will be reported. You configure test
and result information using the Configuration menu. For more information, see
Section 2.1: System Administration Overview.
Only the Access Immunoassay System assays included in the assay protocol file
(APF) can be run on the system. When you install an updated APF, prepare to use any
new test by configuring the following kinds of test information.
• The default sample type
• The units of measure for reporting results
• The result ranges and demographics for associating flags with test results
You can also add the test to a new or existing test panel, include the test in a derived
result, or set up the test as a condition or result of a reflex test.
NOTE
If you send test requests to the UniCel DxI system using an LIS, you may choose
to use either the capabilities of your LIS or the features of the UniCel DxI system
for reflex tests or derived results.

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3.2: Assay Protocol File UniCel DxI Reference Manual
3.2 Assay Protocol File

The tests that are available to run on the UniCel DxI Access Immunoassay System are
defined in an assay protocol file (APF) stored on the instrument. The APF contains all
of the information that the instrument needs to run a test, including how much sample
is required, what reagents to use, incubation steps, calibration information, and so on.
Updating the Use the instructions included with the new APF to update the APF. Updating the APF
APF adds new assays to your system, revises existing assays, and removes assays that are
no longer available. To update the APF, you need:
• The CD containing the new APF
• Installation instructions (included with the CD or DVD)
NOTES
• If the APF includes a new test with a default test ID that is already assigned to
a different test on your instrument, the system automatically renumbers the
new test. The system records the change in the Event Log.
• If the APF includes a new test with a test name that matches a test panel or
derived result name, the system changes the test panel or derived result name
to begin with the letter X. The system records the change in the Event Log.
• When you install a new APF that removes a test that is no longer available, the
system removes the test and all system data that relates to the test. (Patient
data is not removed.) The system records the change in the Event Log.

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UniCel DxI Reference Manual 3.3: Test Setup
3.3 Test Setup

Before you can run an available test on the UniCel DxI instrument, the test must be
set up on the Tests screen. The minimum setup requirement is to enable the test. You
can also change the default sample type and assign reagent pipettors to be available
for each test, define ranges for evaluating quantitative test results, define gray zones
for evaluating qualitative test results, change the units of measure and number of
decimal places for reporting results, and print test setup reports.
Tests Screen Use the Tests screen to:

• Enable and disable tests
• Change the Test ID and the default sample type for a test
• Change the units of measure and number of decimal places for expressing test
results
• Define reference, critical, and LIS ranges for quantitative tests
• Define gray zones for qualitative tests
• Assign reagent pipettors to use for individual tests
• Print setup and ranges reports
• Update the APF
To get to the Tests screen from the Main Menu, select Configure F8, then Tests F2.

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3.3: Test Setup UniCel DxI Reference Manual
2110A.bmp
Filter (Field) Displays the filter and sort order applied to the Tests screen. For more
information, see the Applying Filters and Sort Orders for Tests topic.
APF Revision (Field) Displays the revision number of the assay protocol file (APF). For more
information, see Section 3.2: Assay Protocol File.
Test Name (Field) Displays the test name, which is defined by the APF.
Test ID (Field) Displays the unique test ID for the named test. The initial Test ID is defined
in the APF. Select to change the test ID to another unique number. For more
information, see the Setting Up a Test topic.
Enabled (Box) Select to enable tests. Clear to disable tests. Only enabled tests can be run on
the system.
If you disable a test, all of the test panels, derived results, and reflex tests related to
the test are also disabled. For more information, see the Setting Up a Test topic.
Figure 3-1 Tests Screen Descriptions

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Default Sample (Field and List) Displays the default sample type for the test. The initial sample type
Type is defined in the APF. Select to change the default sample type. For more
information, see the Setting Up a Test topic.
Default Units (Field) Displays the unit of measure corresponding to the default sample type for the
test. The initial units are defined in the APF. To change the units for quantitative tests
only, see the Editing Units topic.
Decimal Places (Field) Displays the number of decimal places that the system uses to report test
results. The initial number is defined in the APF. Select to change the number of
decimal places for quantitative tests. For more information, see the Setting Up a Test
topic.
Revision (Field) Displays the revision number of each test.
Pipettor (Field) Displays the pipettors that are assigned to the test for patient tests, quality
controls and calibrations. To change the pipettor assignment, see the Assigning
Pipettors to Tests topic.
Filter (Button) Select to change the filter and sort order for the tests displayed on the Tests
F1 screen. For more information, see the Applying Filters and Sort Orders for Tests
topic.
Edit Units (Button) Select to change the default unit of measure for the selected sample type.
F2 For more information, see the Editing Units topic.
Ranges (Button) Select to display a menu of the following ranges for the selected test.
F3
Reference Range F1
Select to add or edit a range of values
Critical Range F2
LIS Range F3
For more information, see Section 3.4: Ranges Setup.
Gray Zone (Button) Select to define upper and lower gray zone limits for the selected test. For
F4 more information, see the Setting a Gray Zone topic.
The button is only available for qualitative assays.
Special (Button) Select to display a menu of special features that you can configure for some
F5 assays.
The button is only available for tests that support special features.
Assign Pipettor (Button) Select to assign one or more reagent pipettors to be used for the selected
F6 test. For more information, see the Assigning Pipettors to Tests topic.
Figure 3-1 Tests Screen Descriptions (continued)

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Print (Button) Select to print one or more of the following reports:

F7
• Tests Setup Report. For more information, see the Printing the Tests Setup Report
topic.
• Reference, Critical, and LIS Ranges Reports. For more information, see the
Printing Ranges Reports topic in Section 3.4: Ranges Setup.
Update APF (Button) Select to install an APF on the system. For more information, see the
F8 Updating the APF topic in Section 3.2: Assay Protocol File.
Figure 3-1 Tests Screen Descriptions (continued)
Applying Use this procedure to apply a different filter and sort order for the tests on the Tests
Filters and screen.
Sort Orders for
Tests
1. From the Tests screen, select Filter F1 to display the Filter window.
0828B.bmp
Filter (List) Select a filter that limits or expands the tests that are
displayed on the Tests screen, or are printed in the Test Setup
Report.
Sort Order (Options) Select to change the default sort order of the tests.
Ascending (Box) Select to sort the tests in ascending order. Clear to sort in
descending order.
Figure 3-2 Filter (Tests) Window Descriptions

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2. Select a filter and sort order.
3. Select the Ascending box to sort the tests in ascending order.
 (Optional) Clear the Ascending box to sort the tests in descending order.
The system displays the tests that meet the selected filter parameters on the Tests
screen.
Setting Up a Use this procedure to enable a test, change its test ID, and to change the default
Test sample type, units of measure, or the number of decimal places for expressing test
results.
NOTE
Units of measure, decimal places, and sample type default settings for an onboard
dilution test are independent of the settings for the corresponding parent test.
Beckman Coulter recommends that you use the same settings for both tests of
each assay that supports onboard dilutions. For more information, see the
Onboard Dilutions topic in Section 1.3: Sample Processing Theory.
1. On the Tests screen, select the Enabled box for any test you intend to run on the
system.
NOTES
• New tests received in an updated APF are disabled until you enable them.
Previously enabled or disabled tests are unaffected.
• Onboard dilution tests can be enabled only if the corresponding parent tests
are enabled.
2. To change the test ID, enter a unique number in the Test ID field.
NOTE
Test IDs must be unique. You cannot assign a test ID that is already assigned to
another test or test panel.

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3. To change the default sample type, select a sample type from the Default Sample
Type list.
NOTE
When you request a test, either through the LIS or the system console, you can
override the default sample type by specifying a sample type in the test request.
4. To change the number of decimal places that the system displays in test results,
select the Decimal Places field and enter the number of digits to display after the
decimal point.
NOTE
Changing the number of decimal places does not change the precision of the
assay. For more information, see the reagent instructions for use.
All changes made in the preceding steps take effect immediately.

 (Optional) Edit the units of measure for displaying and printing results. For more
information, see the Editing Units topic.
 (Optional) Define reference, critical, and LIS ranges for quantitative tests. For
more information, see Section 3.4: Ranges Setup.
 (Optional) Set the gray zone for qualitative tests. For more information, see the
Setting a Gray Zone topic.
 (Optional) Set the special dilution factor for tests that support this feature. For
more information, see the Special Dilution Factor topic.
 (Optional) Assign the reagent pipettors that can be used for this test. For more
information, see the Assigning Pipettors to Tests topic.
 (Optional) To document your changes, print the Test Setup Report. For more
information, see the Printing the Tests Setup Report topic.
Disabling a Use this procedure to disable a test.

Test
NOTE
When you disable a test that has an associated onboard dilution test, the dilution
test is also disabled.

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1. On the Tests screen, clear the Enabled box for the test you intend to disable.
The test and any panels, derived results, and reflex tests that include the test are
disabled immediately. For more information, see the Test Panel Setup, Derived Result
Setup, and Reflex Test Setup sections in this chapter.
Editing Units The units of measure are used to calculate and report results. Use this procedure to
edit the units of measure for each sample type that is associated with a test.
NOTES
• You can only change the units for quantitative tests.
• Units and default sample type settings for onboard dilution tests are
independent of the settings for the corresponding parent tests.
Beckman Coulter recommends that you use the same settings for both tests of
each assay that supports onboard dilutions. For more information, see the
Onboard Dilutions topic in Section 1.3: Sample Processing Theory.
• Changing the units affects future test results, but does not change past results.
• If you change the units, the system automatically converts the stored ranges
data (including reference ranges, critical ranges, LIS ranges, and quality
control limits) for that test and sample type to the new unit of measure. This
may cause certain reference, LIS, and control ranges to become invalid. For
• The system does not automatically adjust derived result formulas. For more
information, see Section 3.6: Derived Result Setup.
1. On the Tests screen, select a test to edit.
2. Select Edit Units F2 to display the Edit Unit window.

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0829A.bmp
Test Name (Field) Displays the name of the test.

Test ID (Field) Displays the test ID of the test.
Default (Option) Select the default sample type for the test.
Sample Type (Column) Displays the available sample types for the test.
Units (Column and Field) Displays the unit of measure for the
test for each sample type. To edit the unit for a sample
type, select the Units field and then select a unit of
measurement from the list.
Figure 3-3 Edit Units Window Descriptions
3. Each sample type can have different units associated with its results. Select a
Units field to change, then select the new unit of measure from the list. Repeat for
each sample type that you are editing.
NOTE
The available reporting units for each test are determined by the APF.
 (Optional) To select a different default sample type for this test, select the Default
option to the left of the listed sample type.

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The system records the change in the Event Log.
5. If the test you edited is included in a derived result formula, review and update
the formula as needed. For more information, see Section 3.6: Derived Result
Setup.
6. If the test you edited is set up with range information, review and update the
information as needed. The system automatically converts the range units, but
you may need to adjust the decimal places. For more information, see
Section 3.4: Ranges Setup.
Setting a Gray There are a number of qualitative Access assays for which gray zones, also known as
Zone equivocal zones, are applicable. A gray zone defines a range of values near the cutoff
value for which the results are considered equivocal. Gray zones are not set in the
assay protocol file (APF), but must be configured on your system. If a gray zone is
recommended for a specific assay, the gray zone limits will be defined in the reagent
instructions for use.
When a test result falls in the gray zone, the GRY flag is applied to the result. The
GRY flag indicates that the result is near the cutoff and may require further
interpretation.
For information about the gray zone (GRY) or other non-fatal flags, see Section 4.3:
Reviewing Test Results in the Operator's Guide.
NOTES
• You can only set a gray zone for a qualitative test.
• Refer to the reagent instructions for use to determine if a gray zone is
recommended for a test, and to identify the recommended limits.
• In some cases, the GRY flag may be applied to a result with an S/CO value
which appears to be at the upper or lower limit of the gray zone, so would not
be expected to be in the gray zone. You may also observe multiple results with
the same S/CO, some of which have the GRY flag and some of which do not.
If your laboratory prefers to avoid these situations, see section Gray Zone
Limits Table.

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1. On the Tests screen, select the qualitative test for which you intend to define a
gray zone.
2. Select Gray Zone F4 to display the Gray Zone window.
2111A.bmp
Test Name (Field) Displays the name of the qualitative test.

Test ID (Field) Displays the test ID for the test.
Lower Limit (Field) Enter the lower limit for the gray zone.
Upper Limit (Field) Enter the upper limit for the gray zone.
Figure 3-4 Gray Zone Window Descriptions
3. In the Lower Limit and Upper Limit fields, enter decimal percentages of the
cutoff value.
NOTES
• The values you enter in these fields are not included in the gray zone.
• The lowest supported value for the lower limit is 0.800, which represents a
lower limit of 20% less than the cutoff value.
• The highest supported value for the upper limit is 1.200, which represents an
upper limit of 20% more than the cutoff value.

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 (Optional) To stop gray zone checking, set both the upper and lower limits to
1.000 (the cutoff value).
 (Optional) To document your changes, print the Tests Setup Report. For more
Gray Zone Limits Table

In some cases, the GRY flag may be applied to a result with an S/CO value which
appears to be at the upper or lower limit of the gray zone, so would not be expected to
be in the gray zone. You may also observe multiple results with the same S/CO, some
of which have the GRY flag and some of which do not. This is because the GRY flag
is applied before the final rounding of the S/CO to two decimal places. You cannot
change the decimal precision for a qualitative assay.
The GRY result flag is valid in the above conditions. No corrective action is needed.
However, if your laboratory prefers to avoid these situations, use the following table
when setting gray zones.
Enter this
Target value per the reagent IFU value in the
limit field
 0.800 Greater than or equal to 0.800 0.800

Lower
Limit
> 0.800 Greater than 0.800 0.804
Lower
> 0.900 Greater than 0.900 0.904
Limit
> 1.000 Greater than 1.000 1.004
1.000 Less than or equal to 1.000 1.005
Upper
1.100 Less than or equal to 1.100 1.105
Limit
 1.200 Less than or equal to 1.200 1.200
< 1.000 Less than 1.000 0.995
Upper
< 1.100 Less than 1.100 1.095
Limit
< 1.200 Less than 1.200 1.195
Table 3-5 Gray Zone Limits

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Special In addition to onboard dilution tests, a small number of tests include a special dilution
Dilution Factor process in the APF. These tests, which have test names beginning with "Dil-", differ
from onboard dilution tests because the dilution factor is not fixed in the APF, and
they can be run on samples with manual dilution factors in addition to the special
dilution factor. For more information about onboard dilution tests, see the Onboard
Dilutions topic in Section 1.3: Sample Processing Theory.
NOTES
• Technical Support sets the special dilution factor initially during installation
of your system. Technical Support adjusts the factor as needed after
performing maintenance on the fluidics system.
• Contact Technical Support before changing the special dilution factor. A
dilution factor should only be determined by Technical Support.
• You can only set the special dilution factor for tests that support this feature.
• The TSH3d assay is available on the Special menu, but you cannot set or
change the dilution factor.
Assigning You can set up tests to run using any available reagent pipettors. The UniCel DxI
Pipettors to system runs most efficiently when all pipettors are assigned to a test. Under most
Tests circumstances, there is no need to change pipettor assignments.
NOTES
• When multiple pipettors are assigned to a test, the instrument selects the
pipettor to use when it schedules a test.
• Pipettor assignments are set individually for each test, including onboard
dilution tests and corresponding parent tests.
• When calibrating an assay, all calibrator levels are run using the same
pipettor, which is selected from the pipettors assigned to the test. If that
pipettor is disabled during the run, remaining calibrator levels will not run,
and a supply condition will be displayed on the Supplies Required screen.
• If a test is requested and all pipettors assigned to that test are disabled, the test
will not run, and a supply condition will be displayed on the Supplies
Required screen. For more information, see the Enabling and Disabling
Reagent Pipettors topic in Section 2.3: Supplies Setup.
Use this procedure to assign reagent pipettors to tests.

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1. From the Tests screen, select the test for which you are setting up pipettors.
2. Select Assign Pipettor F6.
3. In the Assign Pipettor window, select the box for each pipettor that can be used
for the test.
NOTE
At least one pipettor must be assigned to each test.
4. Select Done F1 to save the changes and return to the Tests screen.
5. Run QC and verify that the results are in range.
Printing the Use this procedure to print the Tests Setup Report.
Tests Setup
Report NOTE
The report information is limited to tests in the current filter and sort order.
1. From the Tests screen, select Print F7 to display the Print window.
2. Select the Tests Setup Report box.
3. Select OK F1 to print the report.

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Laboratories, Inc.
Laboratory A
123 Lake Street
Tests Setup Report Townsville, ST 33333
UniCel DxI 800, Access Immunoassay System 101 - 555 - 2323 ext. 109
S/N 654321 Jane Smith
Filter: All Tests - Sorted by Test ID - Ascending
Default Sample Decimal

Test Name Test ID Enabled Type Default Units Places Revision Pipettor
Rub-IgG 102 x Serum IU/mL 1 23 1,2

IgM-Toxo 112 Serum S/CO 3 3
Prog 114 Serum ng/mL 2 1 4
hFSH 115 Serum mIU/mL 2 15 1
hLH 116 Serum mIU/mL 2 12 1
Dig 117 x Serum ng/mL 2 22 1
Cortisol 119 Serum ug/dL 2 12 1
TU 120 x Serum %Uptake 1 19 3,4
TotIgE 123 Serum IU/mL 2 22 1,2,3
FOL2 124 x Serum ng/mL 2 21 3
Ferritin 125 x Serum ng/mL 1 14 3
uE3 126 Serum ng/mL 3 1 3
PRL 128 Serum ng/mL 2 13 2
RBC2 133 x Serum ng/mL 2 2 1
TotT4 134 x Serum ug/dL 2 1 3,4
HAV-IgM 141 Serum S/CO 3 3
HBc-IgM 142 Serum S/CO 3 3
HBc-Ab 143 Serum S/CO 3 3
TBhCG2 151 Serum mIU/mL 2 3 3
HBsAb 222 Serum AU/mL 1 18 3,4
FRT4 226 x Serum ng/dL 2 1 3
MRub 233 Serum AU/mL 1 13 2
Page 1 of 2
Technologist ________________________________________ Printed 10-10-2010 10:10
2113C.bmp
Figure 3-6 Tests Setup Report

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UniCel DxI Reference Manual 3.4: Ranges Setup
3.4 Ranges Setup

The UniCel DxI system produces numeric results for quantitative tests,
semi-quantitative tests, and derived results. If a range is also defined for the test or
derived result, the system compares the numeric results to the range before reporting
the results. The system flags the results that are out of range.
Separate ranges for onboard dilution tests and the corresponding parent tests must be
defined. For more information, see the Onboard Dilutions topic in Section 1.3:
Sample Processing Theory.
A result may be compared to multiple ranges. The ranges are determined by various
factors, including patient demographics (age or sex).
You can define three kinds of ranges.

• Reference Range: The range of expected values for a normal demographic
population.
• Critical Range: A range determined by your laboratory, which may depend
on environmental, lab policy, or other factors.
• LIS Range: The range of results to be sent directly to the LIS when the Send
Only Auto-Verified Results value is selected in the Auto Send to LIS list. The
system holds out-of-range results for your review. For more information, see
Section 2.5: LIS Setup.
NOTE
Demographics can be entered for a Patient ID when a test request is made from
the LIS. If you enter a manual test request with the same Patient ID after the
initial LIS request, the DxI system will evaluate the manually requested results
against default ranges even if your laboratory has defined different ranges
(reference, critical, and/or LIS) based on demographics. Test results are not
affected by this issue, but ORH, ORL, CRH, CRL, LRH, or LRL flags may be

C95318-AA
3.4: Ranges Setup UniCel DxI Reference Manual
incorrectly applied or incorrectly not applied to the result if the wrong range is
used for evaluation.
If you enter a manual test request for an assay with established reference, critical,
or LIS ranges, and patient demographics exist, manually compare the test result
to the appropriate range. For more information about patient demographics, see
the Viewing Sample Details procedure in Section 4.3: Reviewing Test Results of
Ranges for a test are retained when the test is disabled and then enabled again.
If a derived result is deleted, or a test is removed from the APF, the associated ranges
are deleted.
Range Use the range windows to:

Windows • Display ranges defined for a test or derived result
• Set the reference, critical, and LIS ranges
• Edit a range or its demographic conditions
NOTE
Because of their similarity, only one of the three range windows is shown here.
0797A.bmp

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Test Name (Field) Displays the name of the test or derived result to which the ranges in this
window apply.
Test ID (Field) Displays the test ID for the named test or derived result.
Units (Field) Displays the unit of measure for the sample type.
Sample Type (List) Displays the sample type of the range. To display or change ranges for a
different sample type, select that sample type from the list.
Range Type (List) Displays the type of range. To display or change the range information for a
different range type, select that range from the list.
Sex (Field and List) Displays the gender for the range described across the row. To set the
gender for the range, select a gender from the list.
Age Range (Fields and Lists) Displays the low and high patient ages for the range described
across the row. To set the age range, enter the low and high numbers and select from
available units.
Range Low and (Fields) Enter the lower and upper limits of the ranges described across the row.
Range High
Clear (Button) Select to delete a selected range in the window.

F3
Figure 3-7 Reference Range Window Descriptions
Setting Up Use this procedure to add or edit reference, critical, or LIS ranges for a test or derived
Ranges result.
1. On the Tests screen or on the Derived Results screen, select the test or derived
result.
2. Select Ranges F3 and then one of the following menu items to display the
corresponding ranges window:
• Reference Ranges F1
• Critical Ranges F2
• LIS Ranges F3
 (Optional) Select a sample type from the Sample Type list if different from the
default.
3. Confirm that the first row contains a generic range. To set up a generic range,
follow these steps:

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a. Select Unknown in the Sex field.

b. Confirm that the Age Range Low and High fields are blank. If necessary,
clear the fields by selecting the contents and pressing the [Delete] key.
c. Enter low and high range values in the Range Low and Range High fields. If
a test does not have a low range, set the value to zero.
4. Select the row of the range to edit or select the blank row at the bottom to add a
new range. (If the bottom row is not empty, select the blank area beneath the
bottom row to create a new blank row.)
NOTE
The following two optional steps set up the sex and age range demographics. You
can set either or both demographics, but you must set at least one.
 (Optional) Select a gender from the Sex field.
 (Optional) Enter or edit the age range:

a. Select low and high age unit values from the lists in the two Units fields.
The low and high age units do not need to be the same. For example, you can
set up a range of from 6 weeks to 2 years.
b. Enter the low and high values in the Age Range Low and High fields.
The ages must not overlap other ranges for the same sex, and must also be
contiguous. For example, the ranges 1-20, 20-40, 40-80 are contiguous.
5. Enter or edit the low and high values in the Range Low and Range High fields. If
a test does not have a low range, set the value to zero.
 (Optional) Continue adding or editing ranges for this sample type and range type,
or select a different sample type or range type to add or edit.
 (Optional) To document your changes, print a range report for the ranges you
added or edited. For more information, see the Printing Ranges Reports topic.
Clearing a Use this procedure to delete a range from a ranges window.

Range
1. On the Tests screen or on the Derived Results screen, select a test or derived
result.

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2. Select Ranges F3 and then one of the following menu items to display the
corresponding ranges window:
• Reference Ranges F1
• Critical Ranges F2
• LIS Ranges F3
 (Optional) Select a sample type from the list in the Sample Type field if different
from the default.
3. Select the row of the range to clear.
4. Select Clear F3. The range is deleted from the window.
 (Optional) To document your changes, print a range report for the range you
cleared. For more information, see the Printing Ranges Reports topic.
Printing Use this procedure to print ranges reports for test setup or derived results.
Ranges
Reports NOTE
The report information is limited to tests in the current filter and sort order.
1. From the Tests screen or from the Derived Results screen, select Print F7 to
display the Print window.
2. Select the boxes for the range reports you intend to print.
NOTE
The Reference Ranges, Critical Ranges, and LIS Ranges Reports are very similar.
Therefore, only the Reference Ranges Report is shown here.

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Laboratories, Inc.
Laboratory A
123 Lake Street
Test Result Reference Ranges Townsville, ST 33333
Test Name Test ID Sample Type Sex Age Range Reference Range
Ferritin 125 Serum Unknown 10.000 - 300.000 ng/mL
Ferritin 125 Serum Male 20.0 Years - 65.0 Years 23.900 - 336.200 ng/mL
Ferritin 125 Serum Female 15.0 Years - 70.0 Years 11.000 - 306.800 ng/mL
VitB12 190 Serum Unknown 180.000 - 914.000 pg/mL
VitB12 190 Serum Unknown 0 days - 6 weeks 160.000 - 1300.000 pg/mL
Page 1 of 1
2114C.bmp
Figure 3-8 Test Result Reference Ranges Report

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UniCel DxI Reference Manual 3.5: Test Panel Setup
3.5 Test Panel Setup

A test panel is a customer-defined grouping of from two to twenty-four tests,
including replicates. When you request that a test panel run, all of the tests in the
panel run on the patient sample. The results of the tests in the panel report
individually.
NOTE
Test panels that are set up on the UniCel DxI system cannot be requested through
an LIS.
You set up a test panel by naming the panel, assigning it a unique test ID, and adding
tests to the panel. You run the test panel by entering a manual test request. For more
information, see Section 3.3: Patient Test Requests in the Operator's Guide.
Test Panels Use the Test Panels screen to:

Screen • Add, edit, or delete a test panel
• Print the Test Panels Setup Report
To get to the Test Panels screen from the Main Menu, select Configure F8, then Test
Panels F3.

C95318-AA
3.5: Test Panel Setup UniCel DxI Reference Manual
2202B.bmp
Filter (Field) Displays the filter and sort order applied to the list of test panels displayed on
the screen.
Panel Name (Field) Displays the name of the test panel which is described across the row.
Test ID (Field) Displays the test ID for the named test panel. Select this field to change the test
ID to another unique number.
Enabled (Box) Select to enable a test panel. Clear the box to disable a test panel. Enabled test
panels are displayed in blue on the test buttons of the Test Request screen. For more
information, see Section 3.3: Patient Test Requests in the Operator's Guide.
Tests in Panel (Field) Displays the list of individual tests that are in the test panel.
Filter (Button) Select to apply a different filter and sort order for the test panels displayed on
F1 the Test Panels screen. For more information, see the Applying a Test Panel Filter
topic.
Add Panel (Button) Select to display the Add Panel window. Use this window to create a new test
F4 panel. For more information, see the Adding a Test Panel topic.
Figure 3-9 Test Panels Screen Descriptions

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Edit Panel (Button) Select to display the Edit Panel window. Use this window to edit the selected
F5 test panel. For more information, see the Editing a Test Panel topic.
Delete Panel (Button) Select to delete the selected test panel. For more information, see the Deleting
F6 a Test Panel topic.
NOTE
Only disabled test panels can be deleted.
Print (Button) Select to print the Test Panels Setup Report. Test panel information prints for
F7 the current filter in the current sort order. For more information, see the Printing the
Test Panels Setup Report topic.
Figure 3-9 Test Panels Screen Descriptions (continued)
Applying a Use this procedure to apply a different filter and sort order to the test panels on the
Test Panel Test Panels screen.
Filter
1. From the Test Panels screen, select Filter F1 to display the Filter window.
0833B.bmp
Filter (Options) Select a filter that limits or expands the number of

test panels that are displayed on the Test Panels screen, or are
printed in the Test Panels Setup Report.
Figure 3-10 Filter (Test Panels) Window Descriptions

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Sort Order (Options) Select an option to change the default sort order of
the test panels.
Ascending (Box) Select to sort the test panels in ascending order or clear
the box to sort them in descending order.
Figure 3-10 Filter (Test Panels) Window Descriptions (continued)
2. Select a filter and sort order.
3. Select the Ascending box to sort the test panels in ascending order.
 (Optional) Clear the Ascending box to sort the test panels in descending order.
The system displays the test panels that meet the selected filter parameters on the
Test Panels Screen.
Adding a Test Use this procedure to add a test panel to the system.
Panel
NOTES
• Each test must be enabled before you can add it to a test panel. For more
information, see the Setting Up a Test topic in Section 3.3: Test Setup.
• You can add up to 100 test panels. When the maximum number of test panels
exists, the Add Panel F4 key is not available on the Test Panels screen. To
add more test panels, you must delete existing test panels.

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1. From the Test Panels screen, select Add Panel F4 to display the Add Panel
window.
2248A.bmp
Panel Name (Field) Enter a unique name for the test panel.
Test ID (Field) Enter a unique test ID for the test panel.
Enabled Tests (List) Displays all of the tests that are enabled on the Tests
screen. Select a test that you intend to add to the panel.
Tests in Panel (List) Displays the tests that have been added to the test panel.
Select a test if you intend to remove it.
Add (Button) Select to add a test selected in the Enabled Tests list
F3 to the test panel. Select multiple times to add replicates of the
selected test.
Remove (Button) Select to remove a test selected in the Tests in Panel
F4 list from the test panel.
Figure 3-11 Add Panel Window Descriptions
2. In the Panel Name field, enter a unique name for the test panel.

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NOTES
• A test panel name must start with a letter and can contain up to eight
characters.
• A test panel name cannot share the name of another test, test panel, or derived
result.
3. In the Test ID field, enter a unique test ID.
4. From the Enabled Tests list, select a test to add to the panel, then select Add F3.
The test is added to the Tests in Panel list.
 (Optional) To add a replicate for the test, select Add F3 again.
5. To add more tests to the panel, repeat step 4 for each test and the optional step for
each replicate.
The system displays the new test panel in the Test Panel window.
 (Optional) To document your changes, print the Test Panels Setup Report. For
more information, see the Printing the Test Panels Setup Report topic.

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Configure F8
All tests for the Yes

test panel
enabled?
Test Panels F3
No
Test Panels
Tests F2
Tests
Add Panel F4
Enable the tests for
the test panel
Add Panels
Enter a unique name and

test ID
Select an enabled test
Select F3 again
Add F3
to add replicates
Are all tests No

added?
Yes
OK F1
2116B.wmf
Figure 3-12 Add Test Panel Flowchart

C95318-AA
Editing a Test Use this procedure to edit a test panel.

Panel
NOTE
Only enabled tests can be added to a test panel. For more information, see the
Setting Up a Test topic in Section 3.3: Test Setup.
1. On the Test Panels screen, locate the test panel to be edited. If needed, apply a
different filter. For more information, see the Applying a Test Panel Filter topic.
2. To disable the test panel, clear the Enabled box. The test panel is disabled
immediately.
3. To change the test ID, select the Test ID field and enter a unique number.
4. Select Edit Panel F5 to display the Edit Panel window. This window is the same
as the Add Panel window (see Figure 3-11), except that the fields contain data.
5. To add a test to the panel, select a test from the Enabled Tests list and then select
Add F3. Select Add F3 again to add each replicate.
6. To remove a test from the panel, select a test from the Tests in Panel list and
then select Remove F4. Select Remove F4 again to remove each replicate.
7. Repeat step 5 or step 6 to add or to remove more tests.

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Deleting a Use this procedure to delete a test panel.

Test Panel
1. On the Test Panels screen, locate the test panel to be deleted. If needed, apply a
different filter. For more information, see the Applying a Test Panel Filter topic.
2. If the test panel is enabled, clear the Enabled box to disable it.
3. Select Delete F6 to delete the test panel.
4. Confirm your selection and then select OK F1 to delete the test panel and exit the
window.
Printing the The Test Panels Setup Report lists the test panels in the current filter and sort order on
Test Panels the Test Panels screen. To print a copy of the report, select Print F7.
Setup Report

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Laboratories, Inc.
Laboratory A
123 Lake Street
Test Panels Setup Report Townsville, ST 33333
Filter: All Panels - Sorted by Panel Name - Ascending
Panel Name Test ID Enabled Tests in Panel
Anemia 801 X Ferritin, FOL2, VitB12
Repro 804 X E2, TBhCG2, uE3
Thyroid 802 TotT4(2), TSH
Cardiac 803 X CK-MB, MYO
Page 1 of 1
2117B.bmp
Figure 3-13 Test Panels Setup Report

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UniCel DxI Reference Manual 3.6: Derived Result Setup
3.6 Derived Result Setup

With some tests results, you can calculate additional results that can be clinically
useful. These additional results are called derived results on the UniCel DxI system.
Derived result names must be unique on the system. Derived result formulas are either
defined in the APF or are set up according to your laboratory preferences.
NOTE
Results must be less than 48 hours old to be used to calculate derived results.
Derived results are reported with other test results on screens and in reports. If one of
the tests specified in the calculation does not produce a numeric result (for example, if
the test produced an OVR or fatal flag), the CCR flag is associated with the derived
result. For more information, see Section 4.3: Reviewing Test Results in the
Operator's Guide.
If your LIS interface is set up to send all results or to send only auto-verified results,
derived results are sent according to that option. For more information, see
You can assign critical, reference, and LIS ranges to derived results. For more
information, see Section 3.4: Ranges Setup.
Derived result formulas are constructed from the following elements.

• One or more test names, which represent the numeric results of enabled tests.
For a quantitative test, the numeric result is the concentration value. For
qualitative tests, the numeric result is the sample-to-cutoff ratio.
• Valid mathematical operators. For a list of these operators, see the Derived
Result Operators topic. Valid operators are also listed in the Add and Edit
Derived Result windows.
• Numeric constants (n), which may be integers or decimal numbers. Numeric
constants are not required components of a derived result formula.

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3.6: Derived Result Setup UniCel DxI Reference Manual
WARNING
The system confirms that derived result formulas are valid mathematical
expressions. However, it may not detect all formula errors. To avoid generating
erroneous patient results, test the formula by running samples of known
reactivity, such as controls and calibrators, before you run patient samples.
Derived Result Only a few mathematical operators can be used to compute derived results. Valid
Operators operations are performed in a certain sequence. Operations with the same priority are
performed from left to right.
Highest priority () operations grouped within parentheses

(performed first)
abs( ), log( ), absolute value, base 10 logarithm, natural
ln( ), and logarithm, and exponential (e^x)
exp( )
(+n) and (-n) positive and negative numbers
Lowest priority ^ exponentiation
(performed last)
* and / multiplication and division
+ and - addition and subtraction
Table 3-14 Valid Derived Result Operators
Example
In this example, parentheses are used to control the order of operation used to
calculate a derived result.
Example Formula: (Test A + Test B) + Test C * n
• First, the results from Test A and Test B are added together.
• Next, the result from Test C is multiplied by n.
• Last, the sum of the first operation is added to the result of the second
operation.

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Derived Use the Derived Results screen to:

Results Screen • Add, edit, and delete derived results
• Print the derived results setup and ranges reports
To get to the Derived Results screen from the Main Menu, select Configure F8, then
Derived Results F4.
2203A.bmp
Name (Field) Displays the name of the derived result formula.

Enabled (Option) Select to enable or clear to disable a derived result formula.
If you disable a derived result, it will not be calculated by the system.
Formula (Field) Displays the formula for calculating the derived result.
Figure 3-15 Derived Results Screen Descriptions

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Units (Field) Displays the reporting units for the derived result.
NOTE
Units defined for derived results are for reporting purposes only, and have no
mathematical significance. Changing the displayed units does not change the
numerical test result value.
Decimal Places (Field) Displays the number of digits after the decimal point that the system reports for
a derived result. Select to change the number of digits.
Predefined (Field) Indicates whether the formula is predefined in the assay protocol file (APF). If
the formula is predefined, you cannot edit the derived result formula.
Ranges (Button) Select to display a menu of the following ranges for the selected derived
F3 result.
Reference Range F1
Select to add or edit a range of expected values
Critical Range F2
LIS Range F3
For more information, see Section 3.4: Ranges Setup.
Add Derived (Button) Select to create a new derived result formula.
Result
F4
Edit Derived (Button) Select to edit the selected derived result formula.
Result
F5
This button is not available if the derived result is predefined.
Delete (Button) Select to delete the selected derived result.

F6
This button is not available if the derived result is enabled or predefined.
Print (Button) Select to print one or more of the derived result reports:
F7
• Derived Results Setup Report. For more information, see the Printing the Derived
Results Setup Report topic.
• Reference, Critical, and LIS Ranges Reports. For more information, see the Printing
Ranges Reports topic in Section 3.4: Ranges Setup.
Figure 3-15 Derived Results Screen Descriptions (continued)

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Adding a Use this procedure to add a derived result formula.

Derived Result
1. From the Derived Results screen, select Add Derived Result F4 to display the
Add Derived Result window.
0803b.bmp
Derived Result (Field) Enter a unique name for the derived result.
Name
Units (Optional) (Field) Enter the unit of measure for the derived result. A
unit of measure is optional.
NOTE
Units defined for derived results are for reporting
purposes only, and have no mathematical
significance. Changing the displayed units does not
change the numerical test result value.
Figure 3-16 Add Derived Result Window Descriptions

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Formula (Field) Enter the formula, using items from the Tests and
Operators fields. You can also use numeric constants.
For more information, see the Derived Result Operators
topic.
Tests (List) Displays all of the enabled tests on the system.
You can use these tests in the Formula field.
Operators (List) Displays the valid arithmetic operators. You can
use these operators in the Formula field. For more
information, see the Derived Result Operators topic.
Clear (Button) Select to clear the Formula field.
F3
Figure 3-16 Add Derived Result Window Descriptions (continued)
2. In the Derived Result Name field, enter a unique name for the derived result.
NOTES
• A derived result name cannot share the name of another test, test panel, or
derived result.
• If a new version of the APF includes a new test with a test name that matches
a derived result name, the system changes the derived result name to begin
with the letter X. The system records the change in the Event Log.
 (Optional) In the Units (Optional) field, enter a unit of measure for reporting the
result.
NOTE
Units defined for derived results are for reporting purposes only, and have no
mathematical significance. Changing the displayed units does not change the
numerical test result value.
3. In the Formula field, enter a derived result formula. You can use numeric
constants, tests included in the Tests list, and arithmetic operators included in the
Operators list. For more information, see the Derived Result Operators topic.
5. To enable the derived result, select the Enabled box.
 (Optional) Define reference, critical, and LIS ranges for the derived result. For
 (Optional) To document your changes, print the Derived Results Setup report.
For more information, see the Printing the Derived Results Setup Report topic.

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WARNING
6. Test the formula with samples of known reactivity, such as controls and
calibrators.
Editing a Use this procedure to edit a derived result.

Derived Result
NOTES
• You cannot edit derived results that are defined in the APF.
• You cannot change the name of a derived result.
• If you edit a derived result, previously calculated results are not recalculated.
1. On the Derived Results screen, select the derived result to edit.
2. To enable the derived result, select the Enabled box for the derived result you
want to enable.
3. To disable the derived result, clear the Enabled box.
4. To change the number of digits after the decimal point that the system reports for
the derived result, enter a number, from 0-4, in the Decimal Places field.
5. Select Edit Derived Result F5 to display the Edit Derived Result window. This
window is the same as the Add Derived Result window (see Figure 3-16), except
that the fields contain data.
6. To change the derived result formula, enter different components in the Formula
field. For more information, see the Derived Result Operators topic. Or, you can
use copy and paste functions to modify parts of the formula. For more
information, see the Copy and Paste topic in Section 1.3: Software Overview of
 (Optional) To change the unit of measure, edit or delete the text in the Units
(Optional) field.

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WARNING
8. Test the formula with samples of known reactivity, such as controls and
calibrators.
Deleting a Use this procedure to delete a derived result.

Derived Result
NOTES
• You can only delete laboratory-defined derived results.
• You can only delete disabled derived results.
1. On the Derived Results screen, select the derived result to delete.
2. Confirm that the derived result is disabled. If it is not, clear the Enabled box.
3. Select Delete F6 to delete the derived result.
4. Confirm your selection by selecting OK F1 to delete the derived result and exit
the window.
Printing the Use this procedure to print the Derived Results Setup report.
Derived
Results Setup NOTE
Report The report information is limited to tests in the current filter and sort order.
1. On the Derived Results screen, select Print F7 to display the Print window.
2. Select the Derived Results Setup Report box.

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Laboratories, Inc.
Laboratory A
123 Lake Street
Derived Results Setup Report Townsville, ST 33333
Name Enabled Formula Units Decimal Predefined

Places
FTIndex X TotT4 * TU / (40) µg/dL 2 Yes
fPSA % X (freePSA/PSA-Hyb)*100 % 2 No
Page 1 of 1
2120B.bmp
Figure 3-17 Derived Results Setup Report

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3.7: Reflex Test Setup UniCel DxI Reference Manual
3.7 Reflex Test Setup

When tests are complete on the UniCel DxI instrument, the system reports the results
for evaluation. You can set up the system to automatically run other tests based on the
results or on information associated with the results. For example, if the test results
are out of range, the system can request additional tests to be run on the sample. In
cases where the result exceeds a specified value, a range, or the highest calibrator
value, the system can request the corresponding onboard dilution test, if one is
provided in the APF (for more information, see the Onboard Dilutions topic in
Section 1.3: Sample Processing Theory).
The additional tests that are automatically requested by the system are called reflex
tests. You define all reflex tests and the conditions under which they are requested.
NOTES
• If a result included in a reflex condition generates a fatal flag, the system
generates an Event Log message and the reflex test is not requested.
• If a test is run STAT, the reflex tests also run STAT.
To provide the system with sufficient sample for running reflex tests without
reloading the sample, you can set up a reserve volume for patient and QC samples on
racks designated for reserve volumes. Then, when samples are presented, the system
attempts to draw and store the reserve volume. Two types of reserve volume are
available: flexible and standard. A flexible reserve volume is drawn only if one or
more of the tests requested for the sample have reflex conditions defined and enabled.
A standard reserve volume is drawn without regard to whether the tests requested for
the sample have reflex conditions. Once drawn, the reserve volume is available for
reflex tests, reruns, late LIS test requests, or for any other test that may be requested
for that sample. Reserve volumes are not drawn from maintenance and calibrator
samples. For more information, see the Setting Up Reserve Volume topic in this
section.
When the system requests a reflex test, it checks for an on-board aliquot. If an aliquot
of the sample is located and it contains sufficient volume, the reflex test is scheduled.
If the sample is not on board, or if there is not enough sample volume remaining, the
reflex test is added to the work pending list, and the Work Pending button turns

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UniCel DxI Reference Manual 3.7: Reflex Test Setup
yellow. You must load a sample to process the reflex test. For more information, see
Section 3.2: LIS Requests and Work Pending in the Operator's Guide.
If your LIS interface is set up to send all results or to send only auto-verified results,
reflex test results are sent according to that option. For more information, see
NOTE
The system confirms that reflex conditions are valid comparative expressions.
However, it may not detect all errors in the expression. To ensure that reflex tests
are run under the intended conditions, test the reflex conditions by running
samples of known reactivity, such as controls and calibrators, before you run
patient samples.
Reflex Reflex conditions are expressions that produce results of TRUE or FALSE. If the
Condition result is TRUE, the reflex test is ordered.
Elements
Reflex conditions are composed of a combination of any of the following elements.
• One or more test names, which represent the results of enabled tests, and any
associated result flags. The reflex test cannot be named in the reflex
conditions. A test name followed by a number sign (#) and a number indicate
the number of the replicate that the results are from.
− For a quantitative test, the result is the numeric concentration value.
− For a semi-quantitative test, the result is the sample-to-cutoff ratio.
− For qualitative tests, the result is the reactive or nonreactive interpretation.
• Valid keywords, which represent patient demographics, result flags, or
qualitative interpretations associated with the results. For a list of these
keywords, see the Reflex Condition Keywords topic. Valid keywords are also
listed in the Add and Edit Reflex Tests windows.
• Valid relational or logical operators. For a list of these operators, see the
Reflex Condition Operators and Syntax topic. Valid operators are also listed
in the Add and Edit Reflex Tests windows.
• Numeric constants, which may be integers or decimal numbers, and must be
in the same unit of measure as the results they are being compared to.

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Reflex Keywords have specific meanings in reflex condition expressions. They must be
Condition spelled correctly in English and composed of all capital letters.
Keywords
Result Flag Keywords Qualitative Result Keywords
OVR - Above highest calibrator REACTIVE - Qualitative test result

LOW - Below stated lower limit NONREACTIVE - Qualitative test result
of sensitivity
Additional Keywords
ORH - Above reference range
ORL - Below reference range AGE - Patient age for an LIS test request
CRH - Above critical range SEX - Patient gender for an LIS test request
CRL - Below critical range MALE - Possible value of the keyword SEX
GRY - Within gray zone FEMALE - Possible value of the keyword SEX
REFLEXED - The named test was run because
of a reflex condition
Table 3-18 Valid Reflex Condition Keywords
For more information about result flags, see Section 4.3: Reviewing Test Results in
Reflex Reflex condition expressions use relational and logical operators, according to
Condition required syntax. Arithmetic operators cannot be used.
Operators
Reflex conditions are evaluated from left to right, according to set priorities. A test
and Syntax
name must be followed on the right by a relational operator. A numeric constant can
only follow a relational operator that follows either a test name or the keyword AGE.
The keyword REFLEXED may only be used before a test name. Additional
syntactical information is provided in the table. Also see the Reflex Test Condition
Special Considerations topic.
Priority Operator Operation, Expression, or Syntax
Evaluated () Grouped expression. For expressions within more than

first one set of parentheses, the innermost expression is
evaluated first.
Table 3-19 Valid Reflex Condition Operators

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Priority Operator Operation, Expression, or Syntax
Relational = Is equal to. Only valid after a test name or the keyword
operators SEX or AGE. Required after the keyword SEX,
(evaluated followed by either the keyword MALE or FEMALE.
second) Also required between a test name and a flag or
qualitative test result keyword. Flag keywords are valid
only after this operator.
<> Does not equal. After a test name, must be followed by
a numeric constant.
< Is less than. Only valid after a test name or the keyword
AGE, and must be followed by a numeric constant.
> Is greater than. Only valid after a test name or the
keyword AGE, and must be followed by a numeric
constant.
<= Is less than or equal to. After a test name, must be
followed by a numeric constant.
>= Is greater than or equal to. After a test name, must be
followed by a numeric constant.
Logical AND The expressions connected must both be true.
operators
OR Only one of the expressions connected must be true.
(evaluated
last)
Table 3-19 Valid Reflex Condition Operators (continued)
Example
In this example, a complex reflex condition runs TestB based on the results of
TestA and demographic factors.
REFLEXED TestA#2=ORH AND (AGE>60 OR AGE<15) AND SEX=MALE
• TestA was run because of another defined reflex condition, and at least two
replicates were run.
• The result from the second replicate of test TestA has the ORH flag associated
with it.
• The age of the patient is either over 60 or less than 15.
• The gender of the patient is male.
• If all statements above are true, the system requests TestB.

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Reflex Test The way a reflex condition is defined can prevent a reflex test from being run when
Condition you might want it to run. Take note of the following special considerations for
Special Con- defining reflex conditions.
siderations
Precision of Results
Use the equal sign (=) cautiously when defining reflex conditions. A numeric result
will not usually be identical to a defined numeric condition. For example, a result of
1.0001 does not meet the condition Test = 1.0000.
Results Near or Outside of Calibration Curve Limits

Because the system cannot calculate results for concentrations that are outside the
limits of the assay calibration curve, a reflex condition based on concentrations near
the limits of the curve will not initiate a reflex test when the concentration falls
outside the limits. To assure that a reflex test is requested for high concentrations
(such as for reflexing a dilution assay), use the OVR flag for a reflex condition instead
of, or in addition to, a concentration value.
Examples
• TESTA=OVR
• TESTA>10000 OR TESTA=OVR
In the first example, the reflex test will run if the concentration is outside the
calibration curve limits.
In the second example, the reflex test will run if the concentration either is greater
than 10,000 units, or is greater than the most concentrated calibrator.

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Reflex Tests Use the Reflex Tests screen to:

Screen • Add, edit, and delete reflex tests
• Suppress redundant reflex tests
• Set up the reserve volume feature
• Designate racks for reserve volume
• Print the Reflex Tests Setup Report
NOTE
For systems running with software version 5.2 or higher,
you can also use the Reflex Tests screen to:
• Direct the system to schedule an alternate pipettor
or reagent pack serial number for a reflex test
• Enable or disable all reflex tests
To get to the Reflex Tests screen from the Main Menu, select Configure F8, then
Reflex Tests F5.
2204C.bmp

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Reflex Test (Field) Displays the name of the reflex test. When the conditions are met, this test is
automatically requested by the system.
Enabled (Box) Select to enable, or clear to disable, a reflex test. Only enabled reflex tests are
automatically requested when the reflex conditions are met.
Replicates (Field) Displays the number of replicates of the reflex test to run. To change the
number of replicates, select the field and enter a new number.
Conditions (Field) Displays the conditions that the system uses to determine whether to run the
reflex test. For more information, see the Reflex Condition Operators and Syntax topic.
Age Units (Field) Displays the unit of measure for ages if the reflex conditions include the AGE
keyword. For more information, see the Reflex Condition Keywords topic.
Alt. Pipettor (Box) For systems running with software version 5.2 or higher, select if the system
should use an alternate pipettor for a reflex test. Clear the box if the system can use any
pipettor for a reflex test.
NOTE
If the alternate pipettor is not available, the system changes the status to Supply
Wait and the reflex test is not run until the alternate pipettor is available.
Alt. Pack (Box) For systems running with software version 5.2 or higher, select if the system
should use a reagent pack with an alternate serial number for a reflex test. Clear the box
if the system can use the same reagent pack serial number for a reflex test.
NOTE
If the alternate reagent pack serial number is not available, the system changes the
status to Supply Wait and the reflex test is not run until the alternate serial number
is available.
Suppress (Box) Select to suppress the reflex test if it duplicates a test already requested for the
sample. Clear the box to run the reflex test without checking for duplicates.
Rack ID Setup (Button) Select to configure rack IDs for the sample container types used by your
F2 laboratory, and to designate racks for reserve volumes. For more information, see the
Setting Up Rack IDs topic in Section 2.3: Supplies Setup.
Reserve Volume (Button) Select to configure reserve volumes for patient and QC samples in designated
Setup F3 racks. For more information, see the Setting Up Reserve Volume topic in this section.
Add Reflex Test (Button) Select to define a reflex test. For more information, see the Adding a Reflex
F4 Test topic.
Edit Reflex Test (Button) Select to edit the existing reflex conditions of the scheduled test. For more
F5 information, see the Editing a Reflex Test topic.
Delete (Button) Select to delete the selected reflex test. For more information, see the Deleting
F6 a Reflex Test topic.
Figure 3-20 Reflex Tests Screen Descriptions

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Print (Button) Select to print the Reflex Tests Setup Report. For more information, see the
F7 Printing the Reflex Tests Setup Report topic.
More Options (Button) For systems running with software version 5.2 or higher, select to enable or
F8 disable all reflex tests. For more information, see the Enabling or Disabling All Reflex
Tests topic.
Figure 3-20 Reflex Tests Screen Descriptions (continued)
Setting Up The UniCel DxI system can be set up to draw and store a reserve volume from
Reserve samples in designated racks for processing reflex tests and test reruns. For more
Volume information, see the Reserve Volume topic in Section 1.3: Sample Processing Theory.
Determining the Amount to Draw

Determine the amount to draw for standard reserve volumes based on the typical
workflow of your laboratory. Consider the current demand for additional sample
volume for reflex tests and test reruns, and the reserve volume setup limits of from
10 μL to 1000 μL.When determining the standard reserve volume, consider the
following:
• If certain tests or test panels frequently result in reflex test requests or test
reruns, allocate enough reserve volume to accommodate the additional tests.
• Select a volume that is large enough for most situations, but small enough to
minimize wasted sample when the reserve volume is not used.
• If certain tests are not frequently reflexed or rerun, you may not want to
include that additional volume in the reserve volume.
For flexible reserve volumes, the system calculates the required reserve volume to
perform first-level reflex tests. If no reflex tests are set up for the requested tests, no
reserve volume is drawn from the sample.
NOTE
For flexible reserve volumes greater than 500 μL, the system may aliquot
insufficient reserve volume for some tests. Affected reflex tests are sent to Work
Pending and the Work Pending icon turns yellow. If this happens, load the
sample again. The reflex test is run automatically.
For tests not frequently reflexed or rerun, or if there is limited availability of sample,
consider loading the sample in racks that are not designated for reserve volume. For
more information, see the Setting Up Rack IDs topic in Section 2.3: Supplies Setup.
If there is insufficient sample to run additional requested tests, the test will be added
to the Work Pending list and you can manually load additional sample. For more
information, see Section 3.2: LIS Requests and Work Pending in the Operator's
Guide.

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Remember to reassess your reserve volume needs as you add or remove reflex tests,
or the demand for additional sample changes.
Enabling and Disabling Reserve Volume

Use this procedure to set up the DxI Reserve volume feature.
1. From the Reflex Tests screen, select Reserve Volume Setup F3 to display the
Reserve Volume Setup window.
NOTE
If the instrument is connected to a laboratory automation system (LAS), a
submenu is displayed. Select DxI Reserve F1 from the submenu to display the
Reserve Volume Setup window. If you want to set up reserve volume for an LAS,
see Using Reserve Volume with a Laboratory Automation System.
2295B.bmp

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Enable Reserve (Box) Select to enable the system to draw reserve volumes
Volume from patient and QC samples on designated racks. Clear to
discontinue drawing reserve volumes.
Standard (Field) Enter the standard number of microliters to draw and
Reserve: store from patient and QC samples in racks that are
Standard designated for standard reserve volume.
Amount (μL)
to Draw
Figure 3-21 Reserve Volume Setup Window Descriptions
2. Select or clear the Enable Reserve Volume box:

• To draw reserve volume from patient and QC samples on designated racks,
select the box.
• To discontinue drawing reserve volume, clear the box.
3. If you use standard reserve volume, set up the amount to draw for standard
reserve volumes. In the Standard Reserve: Standard Amount (μL) to Draw
field, enter the number of microliters to draw in addition to the amount required
for requested tests.
NOTE
If you always use flexible reserve volume, you can ignore this setting.
4. Select OK F1 to save the changes and exit the window.
Designating Racks for Reserve Volume

Reserve volume is drawn only from racks that are designated for reserve volume. To
designate racks for flexible or standard reserve volume, see the Setting Up Rack IDs
topic in Section 2.3: Supplies Setup.
Using Reserve Volume with an Integrated System

If your instrument is part of a UniCel DxC Synchron Access Clinical System
Integrated Workstation, follow the instructions in the UniCel DxC system
documentation.
Using Reserve Volume with a Laboratory Automation System

You can set up the system to draw flexible or standard reserve volume, or no reserve
volume, from all samples presented to the instrument by a laboratory automation
system (LAS). Use this procedure to set up the reserve volume feature for an LAS.

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1. From the Reflex Tests screen, select Reserve Volume Setup F3 and then LAS
Reserve F2 to display the LAS Reserve Volume Setup window.
2344A.bmp
Draw LAS Reserve (Box and options) Select to draw reserve volume from all
Volume patient and QC samples presented to the instrument by
the LAS. When the Draw LAS Reserve Volume box is
selected, options are available to select flexible reserve
volume or standard reserve volume.
• Flexible Reserve (Option): Select to use flexible
reserve volume for all samples
• Standard Reserve (Option): Select to use standard
reserve volume for all samples
Figure 3-22 LAS Draw Reserve Volume Window Descriptions
2. Select the Draw LAS Reserve Volume box if a reserve volume is to be drawn
from all patient and QC samples presented to the instrument by the LAS.
3. If you selected the Draw LAS Reserve Volume box in step 2, select the type of
reserve volume to use:
• To use flexible reserve volume, select the Flexible Reserve option.
• To use standard reserve volume, select the Standard Reserve option.

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Adding a Use this procedure to add a reflex test to the system.

Reflex Test
1. From the Reflex Tests screen, select Add Reflex Test F4 to display the Add
Reflex Condition window.
2122A.bmp
Reflex Test (List) Select the name of the reflex test to be requested. Only
enabled tests are included in the list.
Age Units (List) Select an age unit of measure if the AGE keyword is
(Optional) included in the reflex condition. Otherwise, leave the field
blank.
Conditions (Field) Type the reflex condition, using only the values listed
in the Tests, Keywords, and Operators fields. For more
information, see the Reflex Condition Elements topic.
Tests (Field) Displays the tests that are enabled, and available for
entry in the Conditions field.
Keywords (Field) Displays the keywords that can be entered in the
Conditions field. For more information, see the Reflex
Condition Keywords topic.
Figure 3-23 Add Reflex Condition Window Descriptions

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Operators (Field) Displays the relational and logical operators that can
be entered in the Conditions field. For more information, see
the Reflex Condition Operators and Syntax topic.
Clear (Button) Clears the Conditions field so you can enter new
Conditions conditions. The Conditions field cannot be blank.
F3
Figure 3-23 Add Reflex Condition Window Descriptions (continued)
2. Select a test from the Reflex Test field. The list contains the tests that are enabled
on the instrument.
3. Type the conditions for the reflex test in the Conditions field. The valid values
are listed in the Tests, Keywords, and Operators fields. You must capitalize the
test and keyword values exactly as displayed in the lists. For more information,
see the Reflex Condition Elements topic.
NOTE
You can include spaces in the formula to make it easier for you to read. Spaces
have no effect on the formula.
4. If you included an age condition for the reflex test, select the units from the list in
the Age Units (Optional) field.
5. Select OK F1 to save and apply the changes and exit the window. The reflex test
is enabled automatically.
NOTE
The system checks the formula in the conditions, and displays a message if it
finds errors. The reflex test is added only after the errors are corrected.
6. To change the number of replicates to run of the reflex test, select the Replicates
field and enter a new number from 1-99.
7. To suppress the scheduling of this reflex test when it is already requested for the
same sample, select the Suppress box.
 (Optional) To document your changes, print the Reflex Tests Setup Report. For
more information, see the Printing the Reflex Tests Setup Report topic.
8. Test the reflex test by using samples of known reactivity, such as calibrators or
controls. Edit the conditions as needed. For more information, see the Editing a
Reflex Test topic.

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Editing a Use this procedure to edit a reflex test. You can:

Reflex Test • Enable or disable a reflex test
• Change the reflex conditions
• Set the number of replicates to run
• Set the age units
• Suppress redundant reflex tests
1. On the Reflex Tests screen, select a reflex test to edit.
2. To enable or disable a reflex test, select or clear the Enabled box for the reflex
test.
3. To change the reflex conditions, follow these steps:

a. Select Edit Reflex Test F5 to display the Edit Reflex Condition window,
which is basically the same as the Add Reflex Condition window.
b. Change the conditions for the reflex test in the Conditions field. The valid
values are listed in the Tests, Keywords, and Operators fields. You must
capitalize the test and keyword values exactly as displayed in the lists. For
more information, see the Reflex Condition Elements topic.
NOTE
You can include spaces in the formula to make it easier for you to read. Spaces
have no effect on the formula.
c. To change the age units, select the units from the list in the Age Units field.
d. Select OK F1 to save and apply the changes and exit the window.
The system checks the formula for errors (such as syntax errors), and displays a
message if it finds errors.
4. To change the number of replicates to run of the reflex test, select the Replicates
field and enter a new number from 1-99.
5. To suppress the scheduling of a reflex test when that test is already requested for
the same sample, select the Suppress box.
6. Test the reflex test by using samples of known reactivity, such as calibrators or
controls. Edit the conditions as needed.

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Deleting a Use this procedure to delete a reflex test.

Reflex Test
1. On the Reflex Tests screen, select a reflex test to delete.
2. Confirm that the reflex test is disabled. If it is not, clear the Enabled box.
3. Select Delete F6 to delete the reflex test. The system displays a confirmation
message.
4. Select OK F1 to delete the selected reflex test.
Printing the The Reflex Tests Setup Report is a printout of the entries on the Reflex Test screen.
Reflex Tests To print a copy of the report, select Print F7 on the Reflex Tests screen.
Setup Report System Mode: Any Mode

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Laboratories, Inc.
Laboratory A
123 Lake Street
Reflex Test Setup Report Townsville, ST 33333
Reflex Test Enabled Replicates Conditions Age Units
Dig X 1 Cortisol > 20 AND SEX=MALE
FOL2 X 1 Ferritin=ORL OR VitB12=ORL
freePSA X 2 PSA-Hyb>=4 AND AGE <=30 Years
TSH X 1 TU <= 10 AND AGE>6 Years
Page 1 of 1
2123B.bmp
Figure 3-24 Reflex Tests Setup Report

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Enabling or For systems running with software version 5.2 or higher, use this procedure to enable
Disabling All or disable all of the available reflex tests.
Reflex Tests
1. On the Reflex Tests screen, select More Options F8.
2. Select one of the following options from the menu:

a. Select Enable All F1 to enable all of the reflex tests on the Reflex Tests
screen. A check mark appears in the Enabled box for each reflex test on the
screen.
b. Select Disable All F2 to disable all of the enabled reflex tests on the Reflex
Tests screen. The Enabled box is cleared for each reflex test on the screen.

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UniCel DxI Reference Manual 4: Diagnostics
4
Diagnostics
4.1 Diagnostics...................................................................................................... 4-3
Diagnostics Menu ............................................................................................. 4-3
4.2 Initialize System .............................................................................................. 4-6
Initializing the System ...................................................................................... 4-6
4.3 Prime Fluidics ................................................................................................ 4-10
Priming the Fluidics ........................................................................................ 4-10
Monitoring Priming Information .................................................................... 4-13
4.4 System Check Routines .............................................................................. 4-15
System Checks Screen .................................................................................... 4-16
System Check Data Screen ............................................................................. 4-18
Displaying and Printing System Check Result Data....................................... 4-20
Running System Check Routines.................................................................... 4-22
System Check Expected Results ..................................................................... 4-25
4.5 Analog and Digital Device Diagnostics .................................................. 4-26
Viewing Analog Device Information.............................................................. 4-26
Determining Pressure Sensor Reference Curves ............................................ 4-28
Calibrating Wash Buffer or Liquid Waste Level Sensors............................... 4-30
Calibrating the Wash Buffer Flow Sensor ...................................................... 4-33
Testing Instrument Panel Lights ..................................................................... 4-35
Viewing Peristaltic and Vacuum Pump Status ............................................... 4-36

C95318-AA
4: Diagnostics UniCel DxI Reference Manual
4.6 Mechanics and Alignments ...................................................................... 4-38
Alignments Screen .......................................................................................... 4-38
Viewing Alignment Information..................................................................... 4-41
Homing a Device ............................................................................................ 4-42
4.7 Carryover Testing ......................................................................................... 4-43
Running the Automated Carryover Test ......................................................... 4-43
Reviewing and Printing Carryover Results..................................................... 4-45

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UniCel DxI Reference Manual 4.1: Diagnostics
4.1
Diagnostics
The UniCel DxI system includes features to help diagnose an instrument problem if
one occurs. Using the Diagnostics menu, you can monitor the instrument hardware,
perform diagnostic actions, and verify the effectiveness of troubleshooting steps
taken.
Perform instrument diagnostic activities based on procedures in the UniCel DxI

system documentation, or on instructions you receive when contacting a technical
support representative.
When performing any procedures on your system, always pay careful attention to the
notes, cautions, and warnings in the procedures to avoid injury to yourself or damage
to the instrument.
Diagnostics Use the Diagnostics menu to:

Menu • View or print system parameters
• Run diagnostic or maintenance procedures
• Perform validation procedures after troubleshooting
• Copy test result information to a disk
NOTES
• Many diagnostic procedures should be used only as directed by a technical
support representative or when you are following instructions in the system
documentation.
• Except for LIS/LAS F5 and Diagnostics Reports F7, Diagnostics menu
options cannot be selected while the system is in the Running mode.

C95318-AA
4.1: Diagnostics UniCel DxI Reference Manual
2142E.bmp
Initialize System (Button) Select to initialize all devices. From the Initialize System window, you
F1 can select which vessels are removed from the system, and whether you want to
map each reagent pack in the reagent storage chamber. For more information, see
the Initializing the System procedure in Section 4.2: Initialize System.
Prime Fluidics (Button) Select to prime the substrate fluidics, the sample or reagent pipettors, or
F2 the dispense probes and the first aspirate probe. From the Prime Fluidics
window, you can also select the number of cycles for each component. For more
information, see the Priming the Fluidics procedure in Section 4.3: Prime
Fluidics.
Subsystem (Button) Select to display a menu of subsystem diagnostic options.
Diagnostics
F3 Use this function only as instructed by a technical support representative.
Device Diagnostics (Button) Select to display the Device Diagnostics screen.

F4
Use this function only as instructed by a technical support representative or when
you are following instructions in the system documentation.
Figure 4-1 Diagnostics Menu Descriptions

C95318-AA
UniCel DxI Reference Manual 4.1: Diagnostics
LIS/LAS (Button) Select to display a menu of the LIS and LAS diagnostic options.
F5
Use this function only as instructed by a technical support representative.
Save Data (Button) Select to display a menu of storage options for diagnostic data.
F6
• Copy to Disk F1
(Button) Select to copy information onto a disk. If you need assistance, contact
Technical Support.
• Export Logs F2
(Button) Select to collect and save system status logs to a single location. Use
this function only as directed by a technical support representative or when
Diagnostic Reports (Button) Select to print one of the diagnostic reports.
F7
If you need assistance, contact Technical Support.
Unlock SPU (Button) Select to unlock the SPU cover. This button is unavailable under normal
F8 operating conditions.
Use this function only as directed by a technical support representative or when
Figure 4-1 Diagnostics Menu Descriptions (continued)

C95318-AA
4.2: Initialize System UniCel DxI Reference Manual
4.2
Initialize System
When you initialize the system, the system brings all devices to a known safe state
and ends the routine in the Ready mode. You can select how thoroughly the system
checks for and removes RVs during the initialization. You can also select whether to
map reagent packs, which re-establishes their identity and location. When
initialization is complete, the system is prepared for processing.
Initializing the Use this procedure to initialize the system.

System
CAUTIONS
• Once initialization begins, do not select any buttons or press any keys until
initializing is complete.
• Once initialization begins, do not open the solid waste door. Opening the
solid waste door will cancel initialization and the system will enter the Not
Ready mode. For more information, see Shaking Down the Solid Waste
Container in Section 7.2: Daily Maintenance of the Operator's Guide, or see
Changing a Full Solid Waste Container in Section 2.6: Solid Waste of the
Operator's Guide.
NOTES
• The system needs at least one substrate bottle to complete the initialization
routine. Initializing without substrate will cause the instrument to go to the
Not Ready mode.
• If the system is in the Ready mode, but the SPU is busy, the system cannot be
initialized.
• If the system does not successfully initialize, contact Technical Support.

C95318-AA
UniCel DxI Reference Manual 4.2: Initialize System
1. From the Diagnostics menu, select Initialize System F1 to display the Initialize
System window.
2148a.bmp
Clean Out (Options) Select a sample wheel clean out option.

Sample Wheel
Vessels
• Expired Only - Select to remove only expired samples
from the sample wheel during system initialization. This is
the standard initialization selection.
• All Positions - Select this option only as directed by a
technical support representative. It removes the RVs from
every position in the sample wheel during system
initialization.
Figure 4-2 Initialize System Window Descriptions

C95318-AA
4.2: Initialize System UniCel DxI Reference Manual
Clean Out (Options) Select an analytical module clean out option.

Analytical
Module Vessels
• In Progress Only - Select to remove all RVs in known
positions from the analytical module during system
initialization. This is the standard initialization selection.
• All Positions - Select this option only as directed by a
technical support representative. It checks for and removes
the RVs from every position in the analytical module
during system initialization.
Initialization (Fields) Display the status of an initialization in progress.
status
• Progress bar - Displays a visual measure of the status as
the bar extends to the right end of the field, which
represents completion.
• Text box - Displays the current operation.
• List box - Displays a chronological list of operations.
Remap (Box) Select to re-establish the reagent storage area contents
during system initialization.
Figure 4-2 Initialize System Window Descriptions (continued)
2. Select sample wheel and analytical module clean out options for RVs.
• For a standard initialization, select the Expired Only option for the sample
wheel and the In Progress Only option for the analytical module. During
initialization, the system removes only expired sample RVs from the sample
wheel and all identified RVs from the analytical module.
• Only if a technical support representative instructs you to do so, select the All
positions options for both the sample wheel and the analytical module. If the
non-volatile random access memory (NVRAM) is compromised and the
system cannot verify RV positions, you may need to select this option to
check for and remove the RVs from every position in the sample wheel and
the analytical module.
 (Optional) Select the Remap box to re-establish the location and identity of every
reagent pack in reagent inventory during system initialization. Typical reasons for
remapping:
• The reagent gripper dropped a pack in the reagent storage area.
• Power to the system is lost while a pack was being moved in the reagent
storage area.

C95318-AA
UniCel DxI Reference Manual 4.2: Initialize System
• The cover to the reagent storage area has been removed and packs have been
moved, added, or removed manually.
NOTE
The reagent storage cover should only be removed as directed by Technical
Support or by system documentation.
• The power to the system has been lost for more than 48 hours.
• Technical Support directed you to remap.
NOTE
System initialization with the Remap box selected may take up to 20 minutes.
3. Select OK F1.
The initialization begins, and progress is displayed in the Initialization Status
fields. When initialization is complete, the system returns to the Ready mode.
• If the system does not return to the Ready mode, contact Technical Support.
4. Select Yes F1 to confirm that you are done with the initialization and to return to
the Main Menu.

C95318-AA
4.3: Prime Fluidics UniCel DxI Reference Manual
4.3
Prime Fluidics
Priming fills lines with fluid in preparation for operating the instrument. You can
prime one or more components and you can select the number of priming cycles for
each component. Use the default setting for the number of priming cycles unless the
UniCel DxI documentation or a technical support representative directs you to change
the number.
The following options, available from the Prime Fluidics window, should only be
selected if directed to do so by the UniCel DxI documentation or a technical support
representative.
• Calibrate Drawback - Calibrating substrate drawback determines the amount
of substrate that remains between the substrate probe and the pump after each
substrate dispense. For more information, see Section 1.6: Device Calibration.
• Disable Process Monitoring - The process monitoring system measures the
pressure in the fluidics system and helps to determine if fluids are being
aspirated and dispensed correctly.
Priming the Use this procedure to prime one or more of the pipettors, the dispense probes, the
Fluidics aspirate probe, or the substrate fluidic lines.
System Mode: Ready

1. From the Diagnostics menu, select Prime Fluidics F2 to display the Prime
Fluidics window.

C95318-AA
UniCel DxI Reference Manual 4.3: Prime Fluidics
2226E.bmp
Prime (Boxes) Select one or more components to prime. If you select the Substrate in
use box, you can also calibrate the drawback. For more information, see
Section 1.6: Device Calibration.
NOTES
• Do not select the Calibrate Drawback box unless you are directed to do so
by a technical support representative or by the system documentation.
• The Wash Buffer Bubble Detector selection is only available if your
system is equipped with a wash buffer flow sensor.
Cycles Requested (Field) Displays the default number of cycles for each component. If instructed by
Technical Support or system documentation, select and type a number to change
the number of cycles for a selected component.
Cycles Remaining (Field) Displays the cycles remaining for each device while priming is in progress.
The value in this field decreases by one as each cycle completes.
Disable Process (Box) Do not select this option unless you are directed to do so by a technical
Monitoring support representative or by the system documentation. Selecting this option
temporarily disables process monitoring.
Priming Status (Field) Displays the priming status.
Start Priming (Button) Select Start Priming F2 to prime the selected components. When priming
or starts, the button changes to Stop Priming F2.
Stop Priming
(Button) Select Stop Priming F2 to stop priming at the end of the next complete
F2
cycle.
Figure 4-3 Prime Fluidics Window Descriptions

C95318-AA
Select All (Button) Select to prime the following fluidic components:

F3
• Substrate in use
• Sample pipettor
• Dispense and aspirate probes
• Wash buffer bubble detector (for systems with a wash buffer flow sensor)
• Reagent pipettors (enabled pipettors only)
NOTE
The Select All F3 button does not select the Calibrate Drawback or Disable
Process Monitoring options. If directed to do so by Technical Support, select
these options manually.
Clear All (Button) Select to clear all boxes before selecting components again.
F4
Monitoring (Button) Select to display substrate priming information in the Monitoring

Statistics Statistics window.
F5
For more information, see the Monitoring Priming Information topic.
Figure 4-3 Prime Fluidics Window Descriptions (continued)
2. Select one or more of the components you want to prime.

To prime all components, select Select All F3. To clear your selections and begin
again, select Clear All F4.
• Select the Substrate in use box to fill the fluidic line with substrate from the
active substrate bottle through various fluidic components to the substrate
probe. If you select the Substrate in use box, you can also calibrate the
drawback. For more information, see Section 1.6: Device Calibration.
NOTE
Do not select the Calibrate Drawback box unless you are directed to do so by
a technical support representative or by the system documentation.
• Select the Sample Pipettor box to fill the fluidic line with wash buffer from
the wash buffer reservoir through various fluidic components to the sample
probe.
• Select the Aspirate 1 & Dispense Probes box to fill the fluidic lines with
wash buffer from the wash buffer reservoir through various fluidic
components to the three dispense probes and the first aspirate probe.
• Select one or more Reagent Pipettor boxes to fill the fluidic lines with wash
buffer from the wash buffer reservoir through various fluidic components to
the selected reagent pipettors.

C95318-AA
UniCel DxI Reference Manual 4.3: Prime Fluidics
• Select the Wash Buffer Bubble Detector box to flush wash buffer past the
wash buffer flow sensor. This selection is only available if your system is
equipped with a wash buffer flow sensor.
NOTE
Before priming the wash buffer flow sensor, make sure that the system has
sufficient wash buffer. Priming will fail if either container is low on fluid. For
more information on monitoring wash buffer levels, see Section 2.3: Wash
Buffer in the Operator's Guide.
3. For each component to be primed, confirm or change the default number of

cycles displayed. Change the default number of cycles only as instructed by a
technical support representative or by a procedure you are following in the
UniCel DxI system documentation. To change the number of cycles for a
component, select the Cycles Requested field across from that component and
type the number.
 (Optional) Only as directed by a technical support representative or by the system

documentation, select Disable Process Monitoring. This option is typically used
only when a technical support representative installs the UniCel DxI instrument
and primes the dry fluidic lines.
4. Select Start Priming F2.

The system primes the selected components and displays messages about the
progress of the procedure. When priming is complete, a confirmation message is
displayed.
5. Select OK F1 to return to the Prime Fluidics window.
 (Optional) Select Monitoring Statistics F5 to view substrate priming

information. For more information, see the Monitoring Priming Information
procedure in this section.
6. Select Done F1 to return to the Main Menu.
Monitoring Use this procedure to view priming information for the most recent substrate priming
Priming operation.
Information
System Mode: Ready
Fluidics window.
2. Select Monitoring Statistics F5 to display the Monitoring Statistics window.

C95318-AA
2227A.bmp
Bubble Detector (Field) Displays the outcome of the most recent substrate
Status bubble detector check. The substrate runs through the
bubble detector while priming and either passes or fails
the check.
Percent Fluid (Field) Displays the percentage of substrate detected in
Detected the substrate fluidic line. Values outside the acceptable
range are displayed in red.
Date/Time (Field) Displays the date and time that the substrate was
last primed.
Table 4-4 Monitoring Statistics Window Descriptions
3. View the information presented in the window.

If the bubble detector fails or the percent fluid value is outside the acceptable
range, repeat the substrate prime. For more information, see the Priming the
Fluidics procedure. If the prime fails again, contact Technical Support.
4. Select OK F1 to close the window and return to the Prime Fluidics window.

C95318-AA
UniCel DxI Reference Manual 4.4: System Check Routines
4.4
System Check Routines
The System Check routines are instrument diagnostics procedures that verify the
performance of the UniCel DxI system. Beckman Coulter recommends running all
System Check routines together to confirm that all instrument components are
operating within their expected parameters. There are three separate System Check
routines.
• Washed routine
• Unwashed routine
• Substrate routine
Data from each routine is used separately and in combination with other routines to
calculate results that are important in the confirmation of proper component
operation.

C95318-AA
4.4: System Check Routines UniCel DxI Reference Manual
System The System Checks screen displays the results from the System Check routines.
Checks When all of the routines are run together, the system calculates six different values
Screen and reports the results on the screen.
Use the System Checks screen to:

• View the results for up to 50 maintenance requests for the System Check
routines
• Display the System Check Data screen
2178B.bmp
Out-of-Limits (Field) Displays two icons that identify any System Check routine results outside
Legend of the expected range.
• Red triangles - The results are above (triangle points up) or below (triangle
points down) the expected range.
• Red diamonds - The results are within the expected range, but the %CV is not
within the expected range.
Figure 4-5 System Checks Screen Descriptions

C95318-AA
Date Run Displays the dates of the last 50 maintenance requests for the System Check
routines in a timeline along the bottom of the screen. The system displays up to 25
dates on the screen at one time. Use the arrow buttons at either end of the timeline
to view the additional data points. If more than one maintenance request is run for
the System Check routines, the date is repeated in the timeline.
Point Cursor (Cursor) Highlights the selected System Check routine results with a blue vertical
line. The point cursor is moved to the left or right by selecting another data point
on the screen.
Washed RLU (Chart) Displays the mean RLUs of the Washed routine within the range of
expected results 5,000-20,000 RLUs.
Substrate RLU (Chart) Displays the mean RLUs of the Substrate routine within the range of
expected results: 5,000-9,000 RLUs.
Unwashed RLU (Chart) Displays the mean RLUs of the Unwashed routine within the range of
expected results: 4-10 million RLUs (guideline only).
Wash Efficiency (Chart) Displays the results of the wash efficiency calculation within the range of
PPM expected results: -1.0 - 1.0 PPM (parts per million).
Substrate Ratio (Chart) Displays the results of the substrate ratio calculation within the range of
expected results: 0-1.40.
Substrate: Washed (Chart) Displays the results of the substrate to washed ratio calculation within the
Ratio range of expected results: 0-1.25 (guideline only). Results are displayed only when
all of the System Check routines are requested together.
System Check Data (Button) Select to display the System Check Data screen for the system check
F2 results highlighted by the point cursor. For more information, see the System
Check Data Screen topic.
Figure 4-5 System Checks Screen Descriptions (continued)

C95318-AA
System Use the System Check Data screen to:

Check Data • View the detailed results for a maintenance request for System Check routines
Screen
• Print the System Check Report
2188B.bmp
Completion (Field) Displays the date and time that the results for the System Check routines
were completed.
Wash Efficiency (Field) Displays the results of the wash efficiency calculation in parts per million
(PPM). Out-of-range results are displayed in red.
Substrate Ratio (Field) Displays the results of the substrate ratio calculation. Out-of-range results
are displayed in red.
Substrate: Washed (Field) Displays the results of the substrate to washed ratio calculation if all of the
Ratio System Check routines were requested together. Out-of-range results (guideline
only) are displayed in red.
Figure 4-6 System Check Data Screen Descriptions

C95318-AA
Washed (Fields) Displays the mean RLUs, SD, and %CV of the Washed routine in three
separate fields. Out-of-range results are displayed in red.
The results in all three fields are displayed in red if any replicate generates a fatal
flag.
Clean (Fields) Displays the mean RLUs, SD, and %CV of the clean check in three
separate fields. The results of the clean check are used for troubleshooting
purposes only. As a guideline, the clean check mean should be less than the washed
and substrate check means.
Substrate (Field) Displays the mean RLUs, SD, and %CV of the Substrate routine.
Out-of-range results are displayed in red.
flag.
Unwashed (Field) Displays the mean RLUs, SD, and %CV of the Unwashed routine.
Out-of-range results (guideline only) are displayed in red.
flag.
Sample ID (Column) Displays the name of the check or routine run on each replicate.
RLU (Column) Displays the RLUs for each replicate.
Dark Count (Column) Displays the dark count in RLUs for each replicate.
Drift Corr (Column) Displays the drift correction factor applied to the luminometer reading
for each replicate.
Pipettor (Column) Displays the number of the reagent pipettor (1- 4 for the UniCel DxI 800
instrument, 1 - 2 for the UniCel DxI 600 instrument) used to aliquot sample for
each replicate.
Flags (Column) Displays up to two result flags for each replicate.
Previous Check (Button) Select to display the results for the previous maintenance request for
F2 System Check routines.
Next Check (Button) Select to display the results for the subsequent maintenance request for
F3 System Check routines.
Print (Button) Select to print the System Check Report. For more information, see the
F7 Displaying and Printing System Check Result Data procedure.
Figure 4-6 System Check Data Screen Descriptions (continued)

C95318-AA
Displaying Use this procedure to display and print the detailed data from System Check routines
and Printing for a completed maintenance request.
System
Check Result
Data 1. From the Maintenance Review screen, select System Checks F2.
2. On the System Checks screen, select the completed maintenance request for the
System Check routine results that you intend to display or print. If you cannot
locate the results, use the Arrow buttons to view additional System Check routine
results.
3. Select System Check Data F2 to display the System Check Data screen.
4. To print the System Check Report, select Print F7.
NOTE
The Status column of the report displays the pass/fail status of each of the critical
calculated results. A status of Pass indicates that the result meets the Expected
Result criteria. For more information, see the System Check Expected Results
topic.

C95318-AA
Laboratories, Inc.
Laboratory A
System Check Report 123 Lake Street
UniCel DxI 800, Access Immunoassay System Townsville, ST 33333
S/N 654321 101-555-2323 ext. 109 Jane Smith
Completion: 10/10/10 11:42 Value Status Limits

Wash Efficiency: 0.20 Pass -1.00-1.00
*Substrate : Washed Ratio 0.80 Pass 0.00-1.25
*=Guideline only Substrate Ratio 1.11 Pass 0.00-1.40
System Check Mean Status Limits SD %CV Status Limits

Washed 8616.16 Pass 5000-20000 268.13 3.11 Pass 0.00-12.00
Clean 6910.75 140.01 2.03
Substrate 6873.57 Pass 5000-9000 89.05 1.30 Pass 0.00-5.00
*Unwashed 5755939.00 Pass 4000000-10000000 57194.13 0.99 Pass 0.00-2.00
Sample ID RLU Dark Count Drift Corr Pipettor Flags
Washed 9014 2.9 1.0 4
Washed 8765 2.9 1.0 4
Washed 8761 2.9 1.0 4
Washed 8847 2.9 1.0 2
Washed 8715 2.9 1.0 2
Washed 8500 2.9 1.0 2
Washed 8239 2.9 1.0 1
Washed 8700 2.9 1.0 1
Washed 8209 2.9 1.0 1
Washed 8383 2.9 1.0 3
Clean 6864 2.9 1.0 4
Clean 6929 2.9 1.0 4
Clean 7108 2.9 1.0 4
Clean 6780 2.9 1.0 2
Clean 6772 2.9 1.0 2
Substrate 7241 2.9 1.0 2
Substrate 7081 2.9 1.0 1
Substrate 7621 2.9 1.0 3
Substrate 7084 2.9 1.0 4
Substrate 6837 2.9 1.0 2
Substrate 7005 2.9 1.0 1
Substrate 6791 2.9 1.0 3
Substrate 6799 2.9 1.0 1
Substrate 6847 2.9 1.0 1
Substrate 6963 2.9 1.0 1
Unwashed 5765840 2.9 1.0 1
Unwashed 5839490 2.9 1.0 1
Unwashed 5763130 2.9 1.0 1
Unwashed 5701660 2.9 1.0 1
Unwashed 5709680 2.9 1.0 1
Unwashed 5721760 2.9 1.0 1
Unwashed 5708910 2.9 1.0 1
Unwashed 5870080 2.9 1.0 3
Unwashed 5751040 2.9 1.0 3
Unwashed 5727800 2.9 1.0 3
Technologist ____________________ Page 1 of 2

S/N 654321 Printed 10/10/2010 14:36
2179C.bmp
Figure 4-7 System Check Report

C95318-AA
Running Use this procedure to run a maintenance request for all System Check routines. After
System you prepare and load the rack, the request takes approximately 30 minutes to
Check complete.
Routines
NOTE
Do not run patient, QC, or calibrator samples while System Check routines are
running. The Unwashed routine may fail. Wait until the System Check routines
are complete before loading patient, QC, or calibrator samples.
WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
Required Materials
• 13x100 mm sample rack
• 13x100 mm sample containers (4)
NOTE
Use only the 13x100 mm sample containers when performing the System Check
routine. Using any other sample containers can result in level sensing errors, and
cause the UniCel DxI system to cancel the routine.
• System Check Solution

• Wash buffer
WARNINGS
• Access System Check Solution contains ProClin™ 300 preservative, which
may cause sensitization by skin contact. After contact with skin, wash
immediately with plenty of soap and water. Wear suitable gloves.
• UniCel DxI wash buffer contains a preservative which may cause
sensitization by skin contact. After contact with skin, wash immediately with
plenty of soap and water. Wear suitable gloves.
Procedure Steps
System Mode: Ready
1. From the Sample Manager screen, select New Request F2, and then select
Maintenance F3 to display the Request Maintenance window.
2. From the System Check Routines options, select All.

C95318-AA
3. Select OK F1 to display the Maintenance Requests screen.
4. Enter the rack ID in the Enter ID field and press [Enter].
5. Place four empty 13x100 mm sample containers in a 13x100 mm sample rack.
6. Pipette 4 mL of 100% System Check Solution into the sample container in

position 1.
7. Pipette 2 mL of wash buffer into the sample container in position 2.
8. Leave the sample container in position 3 empty.
9. Prepare a 1:501 dilution of System Check Solution by mixing 20 μL of System

Check Solution with 10.0 mL of wash buffer.
10. Pipette 2 mL of the 1:501 diluted System Check Solution into the sample
container in position 4.
11. Load the sample rack. For more information, see the Loading a Rack for Routine
Processing procedure in Section 3.4: Loading and Unloading Racks in the
Operator's Guide.
12. Compare the obtained results with the expected results. For more information, see
the System Check Expected Results topic.
• If the results are within the expected limits, proceed to step 13.
• If the results are outside the expected limits, repeat the System Check routine.
If out-of-range results persist, contact Technical Support.
13. If you are troubleshooting, continue as instructed in the system documentation or

by a technical support representative.

C95318-AA
Sample Manager
Leave the sample container

in position 3 empty
New Request F2
Maintenance F3
Pipette 2 mL of a 1:501
dilution of System Check
Solution into the sample
Request Maintenance container in position 4
From the System Check

Routines options, select
the All option
Load the sample rack
OK F1
Maintenance Requests
The system begins the
System Check routines
(approximately 30 minutes)
Enter the rack ID and press
[Enter]
Review the system check

results
Place four sample containers
in a 13 x 100 mm sample
rack
Repeat the procedure,

Are the results No contact Technical Support if
Pipette 4 mL of 100% acceptable? the results are still
System Check Solution into unacceptable
the sample container in
position 1
Yes
Pipette 2 mL of wash buffer

Continue with the diagnostic
into the sample container in
or troubleshooting activities
position 2
3008D,svg
Figure 4-8 Running the System Check Routines Flowchart

C95318-AA
System The results of the System Check routines are displayed on the System Checks and
Check System Check Data screens, and on the System Check Report.
Expected
Results NOTE
If a fatal flag is applied to a system check result, the UniCel DxI system will not
use the result when it calculates the mean, SD, or %CV. For more information
about fatal flags, see Section 4.3: Reviewing Test Results in the Operator's
Guide.
System Check Expected Results
Washed routine 5,000-20,000 RLU mean

%CV ≤ 12.00
Clean check* The RLU mean should be less than the
Washed and Substrate RLU means*
Substrate routine 5,000-9,000 RLU mean
%CV ≤ 5.00
Unwashed routine** 4-10 million RLU mean**
%CV ≤ 2.00
Wash efficiency PPM -1.0 - 1.0 PPM
Substrate ratio 0 - 1.40
Substrate: washed ratio* 0 - 1.25*
Table 4-9 System Check Routine Expected Results

* Not a system specification. Use for reference purposes only.
** Not a system specification. Use for reference purposes only. If results are not in the range of 4-10
million, try preparing the 1:501 dilution of System Check Solution again and repeating the System
Check routines.

C95318-AA
4.5: Analog and Digital Device Diagnostics UniCel DxI Reference Manual
4.5
Analog and Digital Device
Diagnostics
Analog devices in the UniCel DxI instrument are controlled by the system software.
Analog device sensors measure temperature, pressure, power supply, and voltage.
You can view analog device information from the Analog Devices window. You can
also calibrate analog device subsystems.
Digital devices monitor and control hardware movements within the instrument. You
can test or view the status of the following digital devices:
• Test instrument panel lights
• View the status of peristaltic and vacuum pumps
CAUTION
Use these procedures only as directed by a technical support representative or if
you are following instructions in system documentation.
Viewing Use this procedure to review the temperatures, pressures, and voltages of various
Analog analog devices. The system updates the Analog Devices window in real-time.
Device
Information
1. From the Device Diagnostics screen, select Analog Devices F2, then Analog
Data F1 to display the Analog Devices window.
Out-of-range values are displayed in red.

C95318-AA
UniCel DxI Reference Manual 4.5: Analog and Digital Device Diagnostics
2235B.bmp
Temperature (Column) Displays the names of the devices with which a temperature sensor is
Sensor associated, or the location of the temperature sensor.
Temp. (°C) (Column) Displays the temperature readings in degrees Celsius for the temperature
sensors named to the left.
Duty Cycle (Column) Displays the percent of time (expressed in hundredths) that the
temperature control devices operate in order to maintain temperature for the
devices to the left. For example, a reading of .23 for the incubator means that in
order to maintain temperature, the incubator heater runs 23 percent of the time that
the instrument is on.
Pressure Sensor (Column) Displays the names of the devices with which a pressure sensor is
associated.
Exception: The air compressor duty cycle is listed after the air compressor sensor.
Value (Column) Displays the pressure or vacuum sensor signals for the sensor listed in
the column to the left.
Exception: The compressor duty cycle value displays the percent of time that the
air compressor operates in order to maintain the air compressor pressure.
Power Supply (Column) Displays the names of power supplies for subsystems, and the PMT
High Voltage category for the luminometer.
Voltage (Column) Displays the voltage readings for the power supplies listed to the left.
Figure 4-10 Analog Devices Window Descriptions
2. Select OK F1, to return to the Device Diagnostics screen.

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Determining Use this procedure to determine a reference curve for pressure sensors associated with
Pressure sample and reagent pipettors.
Sensor
Reference CAUTION
Curves Use this procedure only as directed by a technical support representative or by
the system documentation.

1. From the Diagnostics Menu, select Device Diagnostics F4, Analog Devices F2,
Sensor Calibration F2, then Pressure F1 to display the Pressure Sensor
Reference Curve window.
2236B.bmp
Pressure Sensor (Options) Select a pressure sensor to determine its reference curve.
Reference Curve
NOTES
• To determine reference curves for all pressure sensors, select Determine
All Curves F3.
• You can only select enabled pipettors. For more information, see the
Enabling and Disabling Reagent Pipettors procedure in Section 2.3:
Supplies Setup.
Curve (Field) Displays the date of the last successful reference curve determination for
Determination Date the selected pressure sensor.
Reference Curve (Table) Displays the reference curves and associated curve parameters generated
and Curve for the sensor during the last curve generation. Parameters that are out of range are
Parameters displayed in red and indicate that the curve failed.
Figure 4-11 Pressure Sensor Reference Curve Window Descriptions

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Determine Curve (Button) Select to determine a reference curve for the selected pressure sensor.
F2
Determine All (Button) Select to determine reference curves for all of the pressure sensors.
Curves
F3 NOTE
Reference curves are not determined for sensors of disabled pipettors.
Figure 4-11 Pressure Sensor Reference Curve Window Descriptions (continued)
2. Select a sensor from the Pressure Sensor Reference Curve options.
 (Optional) To view the reference curve data for any of the sensors, select the
sensor. The reference curve parameters are displayed in the table.
 (Optional) To determine reference curves for all of the pressure sensors, select
Determine All Curves F3, then proceed to step 4.
3. Select Determine Curve F2 to begin the determination.
4. When the curve is complete, a window that shows the results of the determination
is displayed.
• If the determination is successful, select OK F1 to return to the Pressure
Sensor Reference Curve window. Then, continue with step 5.
• If the determination fails, repeat this procedure one time. If the determination
fails again, contact Technical Support.
5. Select Done F1 to return to the Device Diagnostics window.

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Calibrating Use this procedure to calibrate wash buffer or liquid waste level sensors.
Wash Buffer or
Liquid Waste CAUTION
Level Sensors Use this procedure only as directed by a technical support representative or by
WARNINGS
• You will come in contact with potentially infectious materials during this
Required Materials
• If calibrating the wash buffer sensors, one full and one empty bulk wash
buffer container
• If calibrating the liquid waste sensors, one full and one empty bulk liquid
waste container
Container Definition
Full Wash A new, unused bulk wash buffer container.

Buffer
Empty Wash A bulk wash buffer container with no remaining wash buffer.
Buffer
Full Liquid A bulk liquid waste container filled to within approximately

Waste one inch (2.54 cm) of the bottom of the container cap.
NOTE
If necessary, fill an empty bulk liquid waste container to
the appropriate level with water.
Empty Liquid A bulk liquid waste container with no liquid waste.
Waste
Table 4-12 Full and Empty Container Definitions

C95318-AA
Procedure
1. From the Device Diagnostics screen, select Analog Devices F2, then Sensor
Calibration F2, and then select one of the following menu options.
• Select Wash Buffer F2 to calibrate the wash buffer sensor.

• Select Liquid Waste F3 to calibrate the liquid waste sensor.
The appropriate Sensor Calibration window is displayed, along with the first step
of the sensor calibration procedure.
NOTE
The Wash Buffer Sensor Calibration window is shown as an example in this
procedure. The Liquid Waste Sensor Calibration window is very similar.
2237A.bmp
Voltages (Table) Displays the volts measured by the level sensors for the front and rear
container positions.
NOTE
When calibrating the wash buffer sensor, the value N/A is displayed in the
No Container column if your system uses the redesigned wash buffer cap and
tube assembly. For more information, see the Changing an Empty Bulk Wash
Buffer Container topic in the Operator's Guide.
Figure 4-13 Wash Buffer Sensor Calibration Window Descriptions

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Calibration Steps (Boxes and Steps) Display the steps necessary for sensor calibration and indicate
which steps are complete. When you select Done F1, the box for the completed
step is selected, and if there is another step, the next step is displayed in the
window.
Procedure Status (Field) Displays the status of the procedure and then the results of the calibration
when the procedure is complete.
Done F1 (Button) Select to indicate that a step has been completed. When the calibration is
complete, select this button to close the window and return to the Device
Diagnostics screen.
Figure 4-13 Wash Buffer Sensor Calibration Window Descriptions (continued)
2. Remove the bulk wash buffer containers or the bulk liquid waste containers as
described in step 1 in the window. For more information about changing bulk
wash buffer containers or bulk liquid waste containers, see Section 2.3: Wash
Buffer or Section 2.5: Liquid Waste in the Operator's Guide.
3. Wait one minute after the second container is removed, then select Done F1 to
display the next step in the Sensor Calibration window.
4. Place full and empty containers as instructed in step 2 in the window.
5. Wait one minute and then select Done F1 to display the next step in the window.
6. Place full and empty supply containers as instructed in step 3 in the window.
7. Wait one minute and then select Done F1 to display the sensor calibration results.
NOTE
If the calibration fails, repeat this procedure. If the calibration fails again, contact
Technical Support.
8. Select Done F1 to return to the Device Diagnostics screen.
9. Take one of the following actions.

• After calibrating the wash buffer sensors, replace the empty container with a
full or partially filled container.
• After calibrating the liquid waste sensors, replace the full container with an
empty container.

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Calibrating Use this procedure to calibrate the wash buffer flow sensor on instruments equipped
the Wash with the sensor. The sensor must be calibrated before tests are run.
Buffer Flow
Sensor CAUTION
Use this procedure only as directed by a technical support representative or by
WARNING
UniCel DxI wash buffer contains a preservative which may cause sensitization
by skin contact. After contact with skin, wash immediately with plenty of soap
and water. Wear suitable gloves.

1. From the Device Diagnostics screen, select Analog Devices F2, then Sensor
Calibration F2, and then Wash Buffer Flow F4 to display the Wash Buffer Flow
Sensor Calibration window.
2318A.bmp
Voltages (Table) Displays the volts measured by the optical and pressure sensors used to
determine acceptable wash buffer flow. The fluid/air voltage ratio and the
minimum and maximum values for all results are also displayed. Results displayed
in red indicate failed areas of the calibration.
Figure 4-14 Wash Buffer Flow Sensor Calibration Window Descriptions

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Procedure and (Field) Displays the procedure to follow and the progress of the calibration.
Status
Start /Continue (Button) Select to start, continue, or complete the calibration procedure. The button
/Done F1 text changes depending on the progress of the calibration.
Figure 4-14 Wash Buffer Flow Sensor Calibration Window Descriptions (continued)
2. Pull out the wash buffer supply drawer (UniCel DxI 800 instrument:
see Figure 1-1 in Section 1.2: Instrument Overview of the Operator's Guide;
UniCel DxI 600 instrument: see Figure 1-2.)
3. Make sure that the bulk wash buffer container in the rear position of the wash
buffer supply drawer is at least one third full. For more information,
see Section 2.3: Wash Buffer in the Operator's Guide.
CAUTION
To avoid contaminating the wash buffer supply, do not touch any of the assembly
tubes in the following steps. Handle the cap and tube assembly by the cap only.
4. Unscrew the cap and tube assembly from the rear container. Lift the tube, or
tubes, connected to the cap and tube assembly completely out of the container,
and then rest the assembly on the top of the container. For more information, see
Figure 2-17 or see Figure 2-18 in the Operator's Guide.
5. Select Start F1.

Wait until the procedure displayed in the window instructs you to insert the
assembly back in the container, then screw the cap and tube assembly in place.
6. Carefully push in the wash buffer supply drawer. Be sure that none of the wash
buffer tubing is pinched between the drawer and the wall.
7. Select Continue F1.
After approximately 30 seconds, the sensor calibration results are displayed. The
calibration is successful if no values are displayed in red.
8. When the flow sensor calibrates successfully, select Done F1 to return to the
Device Diagnostics screen.
NOTE
If the calibration fails, repeat this procedure. If the calibration fails again, contact
Technical Support.

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Testing Use this procedure to test instrument panel lights. The following lights are included in
Instrument the test
Panel Lights • Status indicator (UniCel DxI 800 instrument: see Figure 1-1 in the Operator's
Guide; UniCel DxI 600 instrument: see Figure 1-2)
• System status panel icons (if equipped- see Figure 1-1 in the Operator's
Guide)
• Onload pusher motion indicator (see Figure 3-16 in the Operator's Guide)
• Reagent tray in-use (see Figure 2-35 in the Operator's Guide)
• Substrate load area (UniCel DxI 800 instrument: see Figure 1-1 in the
Operator's Guide; UniCel DxI 600 instrument: see Figure 1-2)

1. From the Diagnostics menu, select Device Diagnostics F4, Digital Devices F3,
then select Panel Lights F1 to display the Panel Lights window.
2. Select OK F1 to test the panel lights.

All the lights on the instrument turn on for approximately 3 seconds, and then
turn off for 3 seconds. Then all lights return to indicating the system status.
 (Optional) If you are unable to observe all lights in the allotted time, select OK F1
to repeat the test.
NOTE
If any of the lights fail to turn on and off, contact Technical Support.
3. Select Cancel F8 to return to the Device Diagnostics screen.

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Viewing Use this procedure to view the status of peristaltic and vacuum pumps.
Peristaltic and
Vacuum System Mode: Ready Not Ready
Pump Status 1. From the Device Diagnostics screen, select Digital Devices F3, and then select
Peristaltic and Vacuum Pumps F2 to display the Peristaltic and Vacuum Pumps
window.
2276A.bmp
Vacuum On (Boxes) Displays whether the wash tower vacuum is on or off. The vacuum is on
when the box is selected.
CAUTION
Do not select or clear this box unless directed to do so by Technical Support or
in system documentation.
Peristaltic On (Boxes) Display whether the peristaltic pump is on or off. The pump is on when the
box is selected.
The pump is turned on or off automatically when the associated Vacuum On box is
selected or cleared.
Figure 4-15 Peristaltic and Vacuum Pumps Window Descriptions

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Index Sensor (Fields) Display the status of the peristaltic pump named to the left.
• If this field displays Pass, the index sensor is successfully detecting the motion
of the peristaltic pump.
• If this field displays Fail, the failure can be either the sensor or the pump.
Vacuum (mmHg) (Fields) Display the vacuum pressure of the pump listed to the left.
Auto Control (Boxes) Display whether auto control is on or off. Auto control uses fluid sensors
and pumps to prevent flooding of the instrument with wash buffer or liquid waste.
Auto control is on when the box is selected.
CAUTION
Turning either of the auto controls off for an extended period of time can
flood the instrument. Use this function only as directed by a technical support
representative or by system documentation.
Liquid Waste Reservoir Auto Control On

When auto control is on, and the sensor detects that the reservoir is nearly full,
liquid waste is pumped from the reservoir into the active bulk liquid waste
container.
Wash Buffer Reservoir Auto Control On
When auto control is on, and the sensor detects that the reservoir is nearly empty,
the pump transfers wash buffer from the active bulk wash buffer container into the
wash buffer reservoir.
Wash Buffer (Fields) Display wash buffer information. The information in the In Use and
Supplies Present indicators and the Estimated % Full fields, is also provided on the Bulk
Supplies screen. For more information, see the Bulk Supplies Screen topic in
Section 2.1: Supply and Supply Conditions Overview of the Operator's Guide.
Wash Buffer Reservoir
(Field) Displays whether the wash buffer reservoir is full, not full, or empty.
Figure 4-15 Peristaltic and Vacuum Pumps Window Descriptions (continued)
2. Select Done F1 to return to the Device Diagnostics screen.

If changes were made in the window, the pumps and auto controls are
automatically restored to the state they were in before you displayed the window.

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4.6: Mechanics and Alignments UniCel DxI Reference Manual
4.6
Mechanics and Alignments
When a UniCel DxI instrument is in the Ready mode, mechanical devices are aligned
properly to their sensors and to their intersecting mechanical devices. When technical
support representatives service the instrument, they often align devices as part of their
verification routine.
Occasionally during troubleshooting, you may need to home devices and view or
adjust alignments.
CAUTION
Use these procedures only as directed by a technical support representative or by
Alignments You use the Alignments screen to:

Screen • View device alignment information in real-time
• Home a device
• Move devices to specified positions
From the Diagnostics menu, select Device Diagnostics F4, Mechanics F1, then
Alignments F2 to display the Alignments screen.

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UniCel DxI Reference Manual 4.6: Mechanics and Alignments
2144a.bmp
Device (Field) Select a device from the alphabetical list of devices. The name of the
selected device is repeated at the top of the middle section of the screen. The
middle section contains alignment information about the device.
NOTE
Device names preceded with an asterisk sort alphabetically above names
without an asterisk.
Position (List) Select an alignment position for the device named in the Device field.
Some alignment positions are intersecting devices, while other positions indicate
states such as end of onload, full, or empty. If the position is a device, the name
of the device is repeated at the top of the right section of the screen above the
alignment information about the device. If the position is not a device, the right
section is empty.
Figure 4-16 Alignments Screen Descriptions

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Selected Device (Option) Select the device to be homed, moved, or otherwise aligned. By default,
the selected device is the one named in the Device field.
If the item selected from the Position list is not a device, it cannot be selected.
Offset (Field and Arrows) The value in an offset field indicates the number of steps in a
positive or negative direction that the device is positioned from a default offset
of 0. Some devices have more than one offset, such as the sample pipettor Y-axis
(front/back) and Z-axis (top/bottom) offsets.
CAUTION
Perform alignments only as directed by a technical support representative
or by the system documentation.
Current Position (Fields) Display the number of steps a device is from the home position. Devices
can display an X (right/left) step count, a Y (front/back) step count, or a Z
(up/down) step count.
Number of Cycles (Field) Displays the number of completed cycles after a cycling operation.
Position/Status (Indicators) Display the position or status of the selected device. Indicators turn
Indicators or stay bright green when the device is in the position named by the indicator or
when device movement activates a sensor.
Home Device (Button) Select to move the selected device to the home position. When homing
F1 is complete, the Home indicator turns bright green. For more information, see the
Homing a Device procedure.
Move X/Y to Position (Button) Select to move the selected device to a right/left (X), front/back (Y), or
F2 up/down (Z) alignment position. If the device is not homed, the system first
or homes the device and then moves the device to the alignment position.
Move Z to Position
F3 Both a device and a position must be selected to move a device to a position.
For more information on moving the aspirate probe plate when doing 10,000 test
maintenance, see the Installing Clean Aspirate Probes topic
in Section 7.5: Test Interval Maintenance: 10,000 Tests of the Operator's Guide.
CAUTION
Figure 4-16 Alignments Screen Descriptions (continued)

C95318-AA
UniCel DxI Reference Manual 4.6: Mechanics and Alignments
Advance CW (Button) Select to move the device clockwise (CW) or counter clockwise (CCW)
F4 to the next position.
or
Advance CCW These buttons are available only when the device can be rotated CW or CCW.
F5
CAUTION
Start Cycling (Button) Select Start Cycling F6 to start cycling the device named in the Device
F6 field. The device cycles between its home position and the alignment position
or until you select Stop Cycling F6. Then the device reaches a known state and
Stop Cycling
stops.
F6
The button name switches between Stop Cycling F6 and Start Cycling F6 each
time you select it.
CAUTION
Alignments / Offsets (Button) Select to display a menu of advanced alignment options.
F7
CAUTION
Perform and save alignments only as directed by a technical support
Motors (Button) Select to display a menu of buttons used to enable and disable motors.
F8
CAUTION
Perform and save alignments only as directed by a technical support
Figure 4-16 Alignments Screen Descriptions (continued)
Viewing Use this procedure to view alignment information.

Alignment
Information
1. From the Diagnostics menu, select Device Diagnostics F4. It may take a little
while for the Device Diagnostics screen to be displayed.
2. Select Mechanics F1, and then Alignments F2. If the system prompts you to
skip the alignment information build process, select Yes F1 to do so.

C95318-AA
3. Select a device from the alphabetical list in the Device field. Note that device
names preceded with an asterisk sort alphabetically above names without an
asterisk.
Alignment information about the device is displayed in the middle section of the
Alignments screen.
 (Optional) Select a device from the Position list.
Position alignment information is displayed in the right section of the Alignments
screen.
4. When you are done viewing an alignment for a device, select another device or
select an appropriate button or tab to exit this screen.
Homing a Use this procedure to home a device.

Device
CAUTION
Use this function only as directed by a technical support representative or by the
system documentation.
NOTE
Always begin this procedure with the covers closed. You cannot successfully
home a device with the covers open.
1. Select Device Diagnostics F4 from the Diagnostics Menu to display the Device
Diagnostics screen.
2. Select Mechanics F1, then select Alignments F2 to display the Alignments
screen.
• If the system prompts you to skip the alignment information build process,
select Yes F1 to do so.
3. Select the device to home from the alphabetical list in the Device field. Note that
device names preceded with an asterisk sort alphabetically above names without
an asterisk.
Alignment information about the device is displayed in the middle section of the
Mechanics screen.
4. Select Home Device F1.
The instrument takes the necessary steps to home the device.
• If the Home sensor indicator turns bright green, the device is homed.
• If the indicator does not turn bright green, contact Technical Support.

C95318-AA
UniCel DxI Reference Manual 4.7: Carryover Testing
4.7
Carryover Testing
Carryover refers to residual analyte being carried on a pipettor from one sample to a
subsequent sample, thereby contaminating the subsequent sample. If the carryover
amount is significant, falsely elevated patient results may be reported.
The UniCel DxI automated carryover test may be performed as needed to fulfill your
laboratory’s inspection requirements. Results that fail will alert you to the need for
corrective action.
Carryover testing is often performed:
• After instrument installation
• After major maintenance procedures or major repairs
• During instrument troubleshooting
Running the Use this procedure to run the automated carryover test on your UniCel DxI
Automated instrument.
Carryover
Test NOTES
• To prevent contamination of the wash buffer cups with Access System Check
solution, it is important that you follow the steps in the order they are
presented.
• Once you prepare and load the racks, the system takes approximately
30 minutes to complete the carryover test.
• The carryover test can only be run when all reagent pipettors are enabled. For
information on enabling pipettors, see the Enabling and Disabling Reagent
Pipettors procedure in Section 2.3: Supplies Setup.

C95318-AA
4.7: Carryover Testing UniCel DxI Reference Manual
Required Materials
• Nine 2 mL sample cups
• Three sample racks for use with 2 mL sample cups
To find rack ID ranges set up for 2 mL cups or to set up racks for use with
2 mL cups, see the Setting Up Rack IDs procedure in Section 2.3: Supplies
Setup.
• Access System Check Solution

• UniCel DxI Wash Buffer
CAUTION
Racks are configured to accept only one type of sample container. The sample
containers used must match the ID configured for the rack. Placing an incorrect
sample container in a rack may damage the system. You can find the rack ID
ranges set up for each type of sample container on the System Setup screen. For
more information, see Section 2.3: Supplies Setup in the Reference Manual.
WARNINGS
• Access System Check Solution contains ProClin™ 300 preservative, which
may cause sensitization by skin contact. After contact with skin, wash
immediately with plenty of soap and water. Wear suitable gloves.
The Carryover Test

System Mode: Ready Running
1. From the Sample Manager screen, select New Request F3, and then select
Maintenance F3 to display the Request Maintenance window.
2. Select the DxI Carryover option, and then select OK F1.

The Maintenance Requests screen is displayed with the first of three Carryover
sample racks selected.
3. Place empty 2 mL cups in positions 1 and 3 of two racks configured for 2 mL

sample cups.

C95318-AA
4. Pipette 0.5 mL undiluted Access System Check Solution in each of the cups in
positions 1 and 3 of the two racks.
5. Place empty 2 mL cups in position 1 of the empty rack, and in positions 2 and 4 of
the other two racks.
6. Pipette 2 mL of wash buffer into the cup in the rack containing a single cup.
7. Pipette 0.5 mL of wash buffer into each of the two empty cups in the other two
racks.
Sample
1 2 3 4
Position
2 mL
Rack 1 — — —
wash buffer
0.5 mL System 0.5 mL 0.5 mL System 0.5 mL
Rack 2
Check Solution wash buffer Check Solution wash buffer
0.5 mL System 0.5 mL 0.5 mL System 0.5 mL
Rack 3
Check Solution wash buffer Check Solution wash buffer
8. Rack 1 is the rack with the single cup. Enter the ID for rack 1 in the Rack field of
the Maintenance Requests screen and press [Enter].
9. Select the icon for rack 2 on the Maintenance Requests screen and enter the ID
for either one of the remaining two racks.
10. Select the icon for rack 3 on the Maintenance Requests screen and enter the ID
for the remaining rack.
11. Load the racks in the order shown on the Maintenance Requests screen. For more
information, see the Loading a Rack for Routine Processing procedure in Section
3.4: Loading and Unloading Racks in the Operator's Guide.
12. Carryover tests take approximately 30 minutes to complete after you load the
racks. Monitor the status of a carryover request, and review results of a completed
carryover test, on the DxI Carryover screen. For more information, see the
Reviewing and Printing Carryover Results procedure in this section.
Reviewing Use this procedure to review and print the results of the DxI carryover test.
and Printing
Carryover
Results 1. From the Main Menu, select Maintenance Review F6, then select
DxI Carryover F3 to display the DxI Carryover screen.

C95318-AA
2329A.bmp
Status (Field) Displays the status of the most recently completed carryover test. The field
is displayed in red when the test fails.
Completion Time (Field) Displays the date and time the test was completed.
Reason (Field) Displays a failure code for a carryover test with the Failed status. This field
is blank if the test passed.
NOTE
If a carryover test fails, the warning event message DxI Carryover Test Failed
is posted to the event log. For more information, see Section 5.4:
Event-Specific Troubleshooting.
Figure 4-17 DxI Carryover Screen Descriptions

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Plot (Chart) Displays the results of the most recently completed carryover test. RLU
values for each replicate run for each of the pipettors is represented as a data point
on the plot. A passing data point is displayed as a green diamond. A failed data
point is displayed as a red X.
Pipettor codes:
• SP – Sample Pipettorxxxx
• RP1 to RP4 – Reagent Pipettors 1 to 4
Baseline RLU (Field) Displays the median RLU value obtained from the first three replicates of
wash buffer pipetted by a reagent pipettor. If any of the three baseline replicates
exceed the maximum RLU value, the baseline RLU value fails and the field is
displayed in red.
Cutoff RLU (Field) Displays the highest acceptable RLU value for each pipettor. The
cutoff RLU value is calculated by adding the baseline RLU value to a
system-defined default. If the maximum RLU value is higher than the cutoff RLU
value, this field is displayed in red, indicating the carryover test failed.
Maximum RLU (Field) Displays the highest RLU value measured for the pipettor. If the
maximum RLU value is higher than the cutoff RLU value, this field is displayed in
red, indicating the carryover test failed.
Mean RLU (Field) Displays the mean RLU value calculated from all replicates for the pipettor.
If the maximum RLU value is higher than the cutoff RLU value, this field is
displayed in red, indicating the carryover test failed.
Minimum RLU (Field) Displays the lowest RLU value measured for the pipettor. If the maximum
RLU value is higher than the cutoff RLU value, this field is displayed in red,
indicating the carryover test failed.
Print (Button) Select to print the DxI Carryover screen.
F7
Figure 4-17 DxI Carryover Screen Descriptions (continued)
2. Select Print F7 to print the DxI Carryover screen. Add the printout to the
Maintenance and Service Log, or to your other lab documentation to indicate
completion of the carryover test.
NOTE
If a carryover test fails, the warning event message DxI Carryover Test Failed is
posted to the event log. For more information, see Section 5.4: Event-Specific
Troubleshooting.

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UniCel DxI Reference Manual 5: Event Log
5 Event Log
5.1 Event Log Overview ...................................................................................... 5-2
Event Log Screen .............................................................................................. 5-2
5.2 Reviewing and Printing the Event Log ....................................................... 5-5
Applying an Event Log Filter ........................................................................... 5-6
Finding an Event ............................................................................................... 5-7
Sorting Events ................................................................................................... 5-8
Printing the Event Log Report .......................................................................... 5-8
5.3 Troubleshooting Caution and Warning Events ....................................... 5-11
Viewing and Printing Event Details................................................................ 5-12
Troubleshooting Events .................................................................................. 5-13
5.4 Event-Specific Troubleshooting ................................................................ 5-15

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5.1: Event Log Overview UniCel DxI Reference Manual
5.1 Event Log Overview

The Event Log is a list of events the UniCel DxI system generates as it monitors the
status of various system parameters. You can review these events to keep informed of
system operations and to assist with troubleshooting.
The Event Log screen displays events from the database according to the applied
filter.
The system retains events for up to 30 days, or until 10,000 events are stored. The
oldest event is overwritten when either of these limits is exceeded.
Event Log Use the Event Log screen to:

Screen • View events
• Locate an event and display detailed information about it
• Display troubleshooting information about an event
• Print the list of events

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UniCel DxI Reference Manual 5.1: Event Log Overview
2245D.bmp
Filter Status (Indicator) Displays the current status of the filter. For more information, see the
Indicator Applying an Event Log Filter topic in Section 5.2: Reviewing and Printing the
Event Log.
Type (Column) Identifies the type of event by the following icons:
Warning - A serious fault or error condition occurred. If the word FATAL
appears at the beginning of the description, do not continue system
operation until you correct the condition.
Caution - A condition requires your attention.
Information - A notable event occurred.
Diagnostic - An event that may be displayed at the request of Technical

Support to aid in diagnosing instrument conditions.
Date/Time (Column) Displays the date and time when the event occurred.
Figure 5-1 Event Log Screen Descriptions

C95318-AA
5.1: Event Log Overview UniCel DxI Reference Manual
Event (Column) Displays a brief description of the event.

Filter (Button) Select to apply a filter to the event list. For more information, see the
F1 Applying an Event Log Filter topic in Section 5.2: Reviewing and Printing the
Event Log.
Troubleshoot (Button) Select to view troubleshooting Help information for the selected event.
F2
This function is not available for information events.
Recover (Button) Select only as directed by a technical support representative or by system
F3 documentation. The button is available only when an event is selected for which
the recover function is available.
Details (Button) Select to display technical information about an event, which may be
F4 useful for Technical Support during troubleshooting. For more information, see the
Viewing and Printing Event Details topic in Section 5.3: Troubleshooting Caution
and Warning Events.
Find (Button) Select to search the event list for a specific event by text in the event
F5 description. If a filter is applied, the search is limited to the events that fit the filter
criteria. For more information, see the Finding an Event topic in Section 5.2:
Reviewing and Printing the Event Log.
Sort (Button) Select to sort the event list in ascending or descending chronological
F6 order. For more information, see the Sorting Events topic in Section 5.2:
Reviewing and Printing the Event Log.
Print (Button) Select to print all events that fit the filter criteria or only the events
F7 currently displayed on the screen. You can also choose to print details. For more
information, see the Printing the Event Log Report topic in Section 5.2: Reviewing
and Printing the Event Log.
Copy to Disk (Button) Select to copy event information onto a disk for analysis by Technical
F8 Support. For assistance, contact Technical Support.
Figure 5-1 Event Log Screen Descriptions (continued)

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UniCel DxI Reference Manual 5.2: Reviewing and Printing the Event Log
5.2 Reviewing and Printing the

Event Log
The Event Log button turns red when a warning event occurs, or yellow when a
caution event occurs. Information and diagnostic events do not change the button
color.
When you display the Event Log screen, the Event Log button returns to neutral and
the most recent event is highlighted. Any events that have occurred since the last time
you viewed the screen are displayed in blue.
If a new event occurs while you are viewing the Event Log screen, the screen is
updated with the new information.
Events are labeled with icons to identify them as caution, warning, information, or
diagnostic events.
Warning event - A serious fault or error condition occurred. If the word

FATAL appears at the beginning of the description, do not continue
system operation until you correct the condition.
Caution event - A condition requires your attention.
Information event - A notable event occurred.
Diagnostic event - An event that may be displayed at the request of

Technical Support to aid in diagnosing instrument conditions.
Table 5-2 Warning, Caution, and Information Icon Descriptions
To use the event log more effectively, you can:

• Apply a filter
• Use the Find option to locate a specific event or set of events
• Display the events sorted in either ascending or descending chronological
order

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5.2: Reviewing and Printing the Event Log UniCel DxI Reference Manual
Applying an Use this procedure to apply a different filter to the Event Log screen.
Event Log
Filter
1. From the Event Log screen, select Filter F1 to display the Filter window.
2209B.bmp
Date Range (Option) Select a date range to include in the filter.

Start Date and (Fields) If you select the Specify option, the Start Date
End Date and End Date fields display the current date.
Select the fields and enter the starting and ending dates to
include in the filter.
The date format selected during system setup determines
the acceptable format for the dates.
Type (Boxes) Select one or more of the following event types:
• Information - Include information events in the filter
• Caution - Include caution events in the filter
• Warning - Include warning events in the filter
• Diagnostic - Include diagnostic events in the filter
View All Events (Button) Select to include all events in the Event Log.
F2
Figure 5-3 Filter (Event Log) Window Descriptions

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2. Select the settings for the filter.

 (Optional) To remove any filter limitations, select View All Events F2.
3. Select OK F1.
The system displays the events that fit the selected filter parameters on the Event
Log screen. The system uses the selected filter until you apply a new one.
NOTE
Diagnostic events are removed from the filter when you exit the Event Log
screen.
Finding an Use this procedure to search the Event Log for a specific event.
Event
NOTE
If a filter is applied, the search is limited to the events that fit the filter criteria. If
your search does not find the expected event, change the filter parameters or
include all events in the filter. For more information, see the Applying an Event
Log Filter topic.
1. From the Event Log screen, select Find F5 to display the Find window.
0628A.bmp
Find What (Field) Enter the text to find.

Direction (Option) Select the Up or Down option to change the
direction of the search.
• Down - The system begins the search at the selected
result and continues down the list.
• Up - The system begins the search at the selected
result and continues up the list.
When a search reaches the top or bottom of the list, the
search continues from the opposite end.
Find Next (Button) Select to find the next event in the selected
F1 direction that includes the text you are looking for.
Figure 5-4 Find (Event Log) Window Descriptions

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2. In the Find What field, enter the text to find.
Example
To find events that contain the word "pipettor" in the event text, enter "pipettor"
in the Find What field.
 (Optional) To change the direction of the search, select the Up or Down option.
3. To find an event that includes the text you entered, select Find Next F1.
The next event that includes the text you entered becomes the selected event.
If the system does not find a match, it displays a message in the status bar.
 (Optional) To find the next event that includes the text you entered, select
Find Next F1 again.
4. Select Cancel F8 to exit the Find window.
Sorting Events Use this procedure to change the sort order of the events in the Event Log.
NOTE
If a filter is applied, the list is limited to the events that fit the filter criteria.
1. From the Event Log screen, select Sort F6 to display the Sort window.
2. Select an option to change the sort order:

• Ascending - The system displays the most recent events at the bottom.
• Descending - The system displays the most recent events at the top.
3. Select OK F1.
The Event Log screen is displayed in the selected sort order. The system uses the
selected sort order until you change it or you restart the system.
Printing the Use this procedure to print the Event Log Report.
Event Log
Report
1. On the Event Log screen, confirm that the events you intend to print are included
in the applied filter. If needed, try finding an event or applying a different filter.
For more information, see the Finding an Event or Applying an Event Log Filter
topics.

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2. Select Print F7 to display the Print window.
0624A.bmp
Print Range (Option) Select a print range option for the Event Log
Report.
• All - Prints all events in the applied filter.
• Current Page - Prints a maximum of ten events
displayed on the Event Log screen.
Print Details (Box) Select to include the details for each event.
Figure 5-5 Print (Event Log) Window Descriptions
 (Optional) To change the print range, select a different option.

• Select the All option to print all events that fit the filter criteria.
• Select the Current Page option to print the displayed events.
 (Optional) To include the details for each event, select the Print Details box. For
more information, see the Viewing and Printing Event Details procedure in
Section 5.3: Troubleshooting Caution and Warning Events.
3. Select OK F1. The report is sent to the printer.
NOTE
If you selected the All option, and there are more than 50 events in the Event Log,
a confirmation message is displayed.

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Laboratory A
Laboratories, Inc.
123 Lake Street
Event Log Report Townsville, ST 33333-3333
UniCel DxI 800, Access Immunoassay System 101-555-2323 ext. 109
S/N 654321, Version 4.4 Jane Smith
______________________________________________________________________________________________________
Filter: On
Type Date/Time Event

04/04/11 5:45 AM Database size management service completed.
Code: 0 Process:DBMaintenanceUD(10a) Run Hours:Test Count: 13:48
Database size management service completed:||Auto-Delete patient samples:
Deleted 0, skipped 12.||Auto-Delete QC samples: Deleted 0, skipped 0.||Auto-Trim
patient samples: Deleted 0, skipped 0.||Auto-Trim QC samples: Deleted 0,
skipped 0.||Clean Curve: Cleaned 0, skipped 0.||Auto-Delete expired off-board
reagent packs: Deleted 0, skipped 0.||
04/04/11 5:45 AM Database size management service activated.

Code: 0 Process:DBMaintenanceUD(10a) Run Hours:Test Count: 13:48
Database size management service activated.
04/04/11 5:45 AM System initialized

Code: 360002 Process: NexGenUIUD(95) Run Hours:Test Count: 13:48
||System initialized
04/04/11 1:08 AM Substrate will expire within three days

Code: 82006 Process: ReduceUDR (000000DA) Run Hours:Test Count: 13:47
Substrate Lot:500505 Serial Number:8 Expiration date 9/11/05 5:47 AM
04/04/11 12:53 AM No substrate bottles are present

Code: 545a Process: INSTRU~1(c5) Run Hours:Test Count: 13:47
System initialization requires the presence of at least one bottle of substrate
@2560233776, Thread:Substrate.Worker,0x0000545A from Subsystem Substrate
during FindHome, dev Substrate: (VType:)
0||Rep:(0-0#0)||Sv:(0-0#0)||Pack:(0-0#0)||Occurrence: 4||First
Event Time: 09/09/05 5:45 AM||Last Event Time: 09/09/05 5:47 AM
04/04/11 12:15 AM Console requested pipettor enabled, but system must be initialized before use
Code: 5404 Process: INSTRU~1(c7) Run Hours:Test Count: 13:47
@536668142, Thread:Dispatcher,0x00005404 from Subsystem ReagentPipettor4
during NoOperation, dev ReagentPipettor: 'Console requested pipettor enabled,
but system must be initialized before use', (VType:)
0.||Rep:(0-0#0)||Sv:(0-0#0)||Pack:(0-0#0)||Occurrence: 1||First Event Time: 9/9/05
12:15:33 AM||Last Event Time: 9/9/05 12:15:33 AM
Page 1 of 1
Technologist ________________________ Printed 4/4/11 05:55 AM
2246D.bmp
Figure 5-6 Event Log Report Example

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UniCel DxI Reference Manual 5.3: Troubleshooting Caution and Warning Events
5.3 Troubleshooting Caution

and Warning Events
If a system error or potential problem generates an event in the Event Log, you can
view troubleshooting information for the event. This troubleshooting information
includes:
• Possible causes for the event.
• Brief outline of troubleshooting instructions.
• Links to detailed procedures. Always review the detailed procedures if you
are not completely familiar with them.
You can view technical information about an event (in English only) in the Details
window. The event details can be useful for troubleshooting. Caution and warning
events may include suggestions for fixing the problem.
Before you contact Technical Support for assistance regarding an event, either print
the event details or write down all of the information displayed in the Details window.
For an overview of troubleshooting events, see the Troubleshooting Events topic in

this section. Also see Section 5.4: Event-Specific Troubleshooting.

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5.3: Troubleshooting Caution and Warning Events UniCel DxI Reference Manual
Viewing and Use this procedure to view the details for an event. Details are provided in the English
Printing Event language only, to assist Technical Support with troubleshooting.
Details
1. On the Event Log screen, select the caution or warning event for which you want
to view details.
2. Select Details F4 to display the Details window.
2269B.bmp
Event (Field) Displays the event selected from the Event Log
screen.
Code (Field) Displays a numeric code that identifies the event.
Date/Time (Field) Displays the date and time the event occurred.
Process (Field) Displays a software process identifier, intended
for interpretation by a technical support representative.
Run Hours:Test (Field) Displays the number of hours that the instrument
Count has been in the Running mode, and then the number of
tests that have been run, separated by a colon.
Instrument (Field) Displays the user-defined system ID.
Table 5-7 Details (Event Log) Window Descriptions

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UniCel DxI Reference Manual 5.3: Troubleshooting Caution and Warning Events
Details (Field) Displays technical information that further

explains the event and may include an abbreviated device
or parameter name. This information is intended for
interpretation by a technical support representative.
Troubleshoot (Button) Select to view troubleshooting information for
F2 the selected event from the Help system.
This button is not available for information events.
Print (Button) Select to print the Event Log Report for the
F7 event displayed in the Details window.
Table 5-7 Details (Event Log) Window Descriptions (continued)
3. To print the event details, select Print F7.
Trouble- For many events, event-specific troubleshooting procedures have been developed. For
shooting more information, see Section 5.4: Event-Specific Troubleshooting.
Events
For some events, only generic troubleshooting information is available. Use this
procedure if you need assistance in responding to these events.
1. Read the event text. Many supply-related caution and warning events are
self-explanatory, and suggest a course of action to correct the problem.
2. Look for other events that may have occurred a short time before or after the
event you are troubleshooting. Equipment failures may produce a series of events
which, when considered together, can provide valuable information for resolving
the issues that caused the events.
3. If you are unable to resolve the problem and need assistance:

a. Print the event details.
• To print details for a single event from the Details window, select Print F7.
For more information, see the Viewing and Printing Event Details topic.
• To print details for multiple events, use the Printing the Event Log Report
procedure in Section 5.2: Reviewing and Printing the Event Log.
• If you are unable to print the details, write down all of the information
shown in the Details window.
b. Contact Technical Support.

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5.3: Troubleshooting Caution and Warning Events UniCel DxI Reference Manual
Event Log
Read event text
No No
Take appropriate action Need help? Multiple related
events?
Yes Yes
Event Log Print F7 Details F4
Print F7
Select the event you need
help for Print
Troubleshoot F2 Select Print Details and a

print range
DxI Help OK F1
Follow troubleshooting
instructions
Contact Technical Support
No Yes
Take appropriate action Need help?
2255D.wmf
Figure 5-8 Troubleshooting Caution and Warning Events Flowchart

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UniCel DxI Reference Manual 5.4: Event-Specific Troubleshooting
5.4 Event-Specific
Troubleshooting
For many events, specific troubleshooting procedures have been developed, and may
be displayed by selecting the Troubleshoot F2 button in the Event Log Details
window. To review possible causes and troubleshooting instructions for selected
events in alphabetical order, see Table 5-9.
Some events include variable information. For example, the name of the related test
or instrument component may be included in the event. Because that text is variable, it
is represented in the event list by an X, Y or Z. Variable text is often provided in
English only.
Event Possible Causes Troubleshooting Instructions
A backwards rack • Backward rack in SPU Clear all backward racks (see Section 6.5).
has been detected
• Damaged rack Clear the damaged rack (see Section 6.5).
APF update attempt APF or AAF disk is not for this 1. Remove the disk from the CD-ROM/DVD drive.
with a disk from immunoassay system • If the removed disk is not for the UniCel DxI system, begin
another system the update APF procedure again with the correct system
failed disk.
• If the removed disk is for the correct system, contact
Technical Support for assistance.
APF update attempt APF disk is from a previous APF 1. Remove the disk from the CD-ROM/DVD drive.
with a disk from a 2. From the Main Menu, select Configure F8, then Tests F2 to
previous revision display the Test screen. Compare the APF revision number to
failed the number on the removed CD-ROM.
• If the removed disk is for a revision number lower than the
current APF, begin the update APF procedure again with a
disk with the same or a higher revision number.
• If the removed disk is for the same or a higher revision
number, contact Technical Support for assistance.
Table 5-9 Alphabetical List of Events

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5.4: Event-Specific Troubleshooting UniCel DxI Reference Manual
Aspiration monitor • Problems with cleaning 1. If error occurred during clean routine, prepare new cleaning
detected possible solutions solutions.
obstruction 2. Run clean routine again.
3. Contact Technical Support for assistance if failures continue.
• Clot or other solids in patient 1. Prepare a new sample.

sample 2. Run test again.
• Sample pipettor pressure sensor 1. Determine a new pressure sensor reference curve for the
needs reference curve sample pipettor (see Section 4.5).
2. Run test again.
• Reagent pipettor pressure 1. Determine a new pressure sensor reference curve for the
sensor needs reference curve indicated reagent pipettor (see Section 4.5).
2. Run test again.
• Probe is obstructed Contact Technical Support for assistance.

• Pressure sensor failure
Assay updated to a • Incorrect APF used for update When an APF is updated to an earlier APF, assays not on the
revision from an • Intentional update to an earlier earlier APF CD are deleted as obsolete. Assays on the earlier
earlier APF: X APF APF CD are updated to the earlier revision.
• If the incorrect APF CD was used for the update, contact
Technical Support to discuss restoring the system to the
backup you made before updating the APF.
• If the update was intentional, continue processing.
Bulk RV feeder: • Encoder failure Contact Technical Support for assistance.
Elevator encoder • Loose motor shaft sprocket
and motor mismatch
during initialization
• Elevator motor failure
Bulk RV feeder: • Index sensor failure Contact Technical Support for assistance.
Elevator index
sensor failure
Bulk RV feeder: • Hopper sensor failure 1. Open the vessel hopper and if the supply is low, add RVs (see
Failed to fill the • Vessels are located in front of Section 2.4 in the Operator's Guide).
chute, vessel hopper the elevator preventing elevator 2. If RVs are not needed or if the system does not recover with
full entry additional RVs, contact Technical Support for assistance.
Bulk RV feeder: • Vessel hopper out of RVs 1. Open the vessel hopper and if the supply is low, add RVs (see
Failed to fill the • Vessels are located in front of Section 2.4 in the Operator's Guide).
chute, vessel hopper the elevator preventing elevator 2. If RVs are not needed or if the system does not recover with
low entry additional RVs, contact Technical Support for assistance.
Table 5-9 Alphabetical List of Events (continued)

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Bulk RV feeder • RV jam at top or bottom of bulk 1. Select Recover F3 if the button is available on the Event Log
motor is jammed feeder screen. Then select Initialize Subsystem F1.
• RV pusher not fully retracted 2. If the Recover F3 button is not available, or if the system does
• Defective motor index sensor not recover, contact Technical Support for assistance.
• Defective motor
• MCC board
• MCC motor cabling
Bulk RV feeder: • Defective home sensor Contact Technical Support for assistance.
Pusher homing • Pusher obstruction
failure
• Defective pusher motor
• Motor shaft pulley slipping
• Incorrect belt tension
• Motor or sensor disconnected
Bulk RV feeder: • RV jam in orienter Contact Technical Support for assistance.

Pusher motion error • Incorrect belt tension
• Motor shaft pulley slipping
• Scoop and pusher not aligned
• Pusher motor failure
• Pusher obstruction
Bulk RV feeder: • RV jam at top or bottom of bulk Contact Technical Support for assistance.
Upper or lower feeder
ejector motion • RV pusher not fully retracted
failure
• Bent push rod
• Incorrectly positioned sensor
• Sensor failure
• RV elevator chain not in
position
• MCC board
• MCC motor cabling
• Low air pressure
Calibration failed • Insufficient calibrator volume 1. Review the Event Log and troubleshoot according to any
for assay X • Insufficient substrate device error event with a date and time shortly before this
event.
• Expired calibrator or reagent
pack 2. If there are no device error events shortly before this event,
follow the assay calibration troubleshooting instructions in
• Calibrators not in correct order Section 5.5: Troubleshooting Failed Calibrations of the
on sample rack
Operator's Guide.
• Unstable or contaminated 3. Repeat the calibration. If you need assistance or if the problem
calibrator or reagent
persists, contact Technical Support.
• Level sense failure

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Clean routine failed • Probes contaminated 1. Run Special Clean routine (see Section 7.2 in the Operator's
• Mechanical failure Guide).
2. Review the Event Log and troubleshoot according to any
device error event with a date and time shortly before this
event.
• Expired or wrong solution used 1. Mix new cleaning solutions (see Section 7.2 in the Operator's
during clean routine Guide).
2. Run Special Clean routine.
Communication • Error in communication 1. Go to the screen that was displayed when the error occurred.
Error between the instrument and the Exit and re-enter the screen.
PC • If the problem persists, continue troubleshooting.
2. Restart the PC (see Section 6.3).
• If the problem persists, continue troubleshooting.
3. Restart the instrument (see Section 6.3).
• If the problem persists, contact Technical Support.
Dark count reading • External light leakage 1. Verify that covers are securely closed(see Section 6.3).
out of range • Wash buffer spill into wash • If the problem persists, continue troubleshooting.
carousel from probes or duck 2. Replace the duck bill valve. For more information, see
bill valve Section 7.4 in the Operator's Guide.
• Dried wash buffer in wash 3. Contact Technical Support for assistance if failures continue.
carousel/luminometer cutout
• Adjacent hole crosstalk
• Luminometer electronics
problem
Dispense probe DX: • System interruption during 1. Prime all fluidics (see Section 4.3).
Drawback is dispense operation 2. Contact Technical Support for assistance if failures continue.
compromised, so • Pump or valve failure
tests cannot run

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DxI carryover test • Dirty probes 1. Run the Special Clean routine (see Section 7.2 in the
failed Operator's Guide).
2. Repeat the carryover test with new sample cups and fresh
solutions (see Section 4.7).
3. If the carryover test fails again, contact Technical Support.
• Contaminated wash buffer or 1. Repeat the carryover test with new sample cups and fresh
Access System Check solutions (see Section 4.7).
2. If the carryover test fails again, contact Technical Support.
• Sample or reagent pipettors Contact Technical Support for assistance.

• Y and Z alignments of the
pipettors
• Flat tubing on the peristaltic
pumps
• Clogged wash tower nozzle or
tubing
• Low or blocked wash tower
vacuum
• Defective probes
• Baseline failure
Execution of An attempt was made to load or Do not install any software except as directed by the system
unauthorized run unauthorized software on the documentation or a Beckman Coulter technical support
application PC or instrument representative. Do not use the external computer to view
prevented documentation other than the system Help.
1. Cancel the software installation and remove the software
media.
2. Continue normal operation of the system.
Note: If you received this event message while following the
directions in your system documentation, contact Technical
Support.
Fluidics process • Wash buffer flow sensor needs 1. Calibrate wash buffer flow sensor (see Section 4.5).
monitoring sensor calibration 2. Determine pressure sensor reference curve for the sample
not calibrated, • Pressure sensors need reference pipettor (see Section 4.5).
cannot load racks curves 3. Determine pressure sensor reference curves for reagent
• Pump failure pipettors (see Section 4.5).
4. Load racks (see Section 3.4 in the Operator's Guide) and
continue processing.

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Fluid type in LIS • LIS test request had incorrect 1. Confirm that the sample type specified in the test request is
test request is not sample type correct for the patient sample.
supported • Sample type of the test request • If the sample type was not correct, request the test again
is not supported for that test in (see Section 3.3 in the Operator's Guide) with the correct
the APF sample type.
2. Check the reagent instructions for use to verify that the
specified sample type is supported for the requested test.
• If the assay cannot be run on this sample type, notify your
supervisor.
3. If you have a sample which can be tested with this assay,
request the test again and load the sample.
4. If you need assistance or if the problem persists, contact
Technical Support.
IND flag is • For sandwich assays, which 1. For IND flagged results which meet the following criteria,
associated with the use positive slope calibration dilute and rerun the sample:
result curves, the result is at the low • The result is on a competitive assay, and
end of the concentration curve
• Sample dilution is allowed for the assay, and
and cannot be distinguished
from a system failure because • The sample RLU is low.
the RLU reading is too low. See the reagent instructions for use to determine the assay type
• For competitive assays, which and whether sample dilution is allowed.
use negative slope calibration 2. Rule out a system problem by reviewing the Event Log for
curves, the result is at either: error events with a date and time shortly before this event.
• The high end of the Troubleshoot accordingly.
concentration curve and 3. If you have ruled out a system problem and the IND flag event
cannot be distinguished from is the only issue, recalibrating the affected assay may resolve
a system failure because the the problem.
RLU reading is too low, or • Recalibrate the assay using a new reagent pack and a new
• The low end of the set of calibrators.
concentration curve and • Run QC.
cannot be distinguished from
a system failure because the • Repeat the test on the affected sample.
RLU reading is too high. If IND flags persist, contact Technical Support.

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Insufficient sample • Incorrect or undefined sample 1. Verify that the sample container is in a rack configured for the
in sample tube container container type being used:
Insufficient sample
• Not enough sample in sample a. Select Sample Manager F1, then Views F1, then
container Exceptions F4.
in sample tube for
reserve volume • Misaligned sample container or b. Note the rack ID of the sample that the error occurred on,
rack then clear the exception (see Section 3.1 in the Operator's
• Leaking fittings Guide).
• Defective sample pipettor c. Remove the rack from the offload area of the SPU (see
Section 3.4 in the Operator's Guide).
• Defective electronics board
d. Select Configure F8, then System Setup F1, then Rack ID
Setup F8.
e. Find the rack ID identified in step b and note the sample
container type configured for the rack.
f. According to the rack setup, determine whether the correct
container type was used for the sample (see Section 2.3). If
the rack or container is not correct, place the container in an
appropriate rack or move the sample into an appropriate
container.
2. Verify that there is enough sample for requested tests (see
Appendix A in the Operator's Guide) and, as applicable, for
the reserve volume (see Section 3.7).
3. Verify that the sample container is properly aligned in the rack
(see Section 3.4 in the Operator's Guide).
4. Repeat the test.

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Insufficient sample • Bubbles in sample vessel from 1. Prime the sample pipettor (see Section 4.3).
volume in sample sample pipettor 2. Verify that the sample container is in a rack configured for the
vessel • Insufficient volume in sample container type being used:
vessel from sample pipettor a. Select Sample Manager F1, then Views F1, then
• Carriage RV top alignment Exceptions F4.
• Leaking fittings b. Note the rack ID of the sample that the error occurred on,
• Defective ultrasonics board or then clear the exception (see Section 3.1 in the Operator's
cable connections Guide).
c. Remove the rack from the offload area of the SPU (see
Setup F8.
container.
Appendix A in the Operator's Guide) and, as applicable, for
4. Repeat the test.
Interacting • See other subsystem errors 1. Review the Event Log and troubleshoot according to any
subsystem was device error event with a date and time shortly before this
disabled: X event.
2. Initialize the system (see Section 4.2).
Interacting
subsystem was not 3. Contact Technical Support for assistance if failures continue.
ready: X
Internal probe wash • Pump dispense obstructed 1. Prime all fluidic components (see Section 4.3).
pressure outside of • Pump pressure sensor 2. Contact Technical Support for assistance if failures continue.
limits
Invalid reagent • Defective bar code label on 1. Open the reagent load door (see Section 2.7 in the Operator's
barcode: X reagent pack Guide).
Invalid reagent
• Defective barcode reader 2. Inspect the tray for improperly seated reagent packs. If found,
• Reagent load tray is out of seat them properly in the tray.
barcode length: X
alignment with the bar code 3. Check the reagent pack bar codes for damage. If damaged,
reader remove the pack and load a new one.
4. Check for moisture on top of the reagent pack bar code labels.
If found, wipe moisture off with clean, lint-free tissue.
5. Close the reagent load door.
6. If the problem is not resolved, initialize the system (see
Section 4.2).

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Invalid reagent slot • Processor, memory, or UI 1. Shut down the instrument and turn off the power switch (see
number software corrupted Section 6.3).
2. Turn on the power switch to restart the instrument (see
Section 6.3).
No reagent pipettor • Pressure sensor needs reference 1. Review event details (see Section 5.3) to identify which
pressure sensors curve reagent pipettors need reference curves.
calibrated • Pressure sensor reference curve 2. Determine pressure sensor reference curves for reagent
failed pipettors (see Section 4.5).
No reagent pipettors • No reagent pipettors are 1. Identify the test not run in the event parameter (X) or in the
are available to run assigned to the test event details (see Section 5.2).
No reagent pipettors
• Assigned reagent pipettors are 2. Check the Test Setup screen to verify that the test has assigned
disabled reagent pipettors (see Section 3.3). Assign as needed.
are available to run
test: X 3. Check the Supplies Setup window to verify that reagent
pipettors assigned to the test are also enabled (see Section 2.3).
Enable as needed.
No slot available in • Reagent storage area is full 1. Check the reagent inventory (see Section 2.8 in the Operator's
reagent storage Guide).
chamber for reagent 2. If all slots are full, unload one or more packs (see Section 2.7
pack in the Operator's Guide).
3. Load the reagent pack (see Section 2.7 in the Operator's
Guide).
No tube type is • Rack ID is not set up 1. Unload the rack (see Section 3.4 in the Operator's Guide).
assigned to this rack • Bar code label not read 2. Verify that the rack is set up properly:
ID correctly due to bad alignment a. Select Configure F8, then System Setup F1, then Rack ID
or faulty label Setup F8.
• Defective SPU bar code reader b. Confirm that the rack ID has a container type assigned.
c. If necessary, set up the rack ID for the correct container type
(see Section 2.3).
3. Load the rack again.
4. If failures continue, put the samples in another rack and reload.

C95318-AA
Onboard dilution • Onboard dilution test ordered The DxI system cannot accept a request for an onboard dilution
test cannot be on a manually diluted sample on a diluted sample. Refer to the LIS or the DxC integrated
ordered on a diluted (with a dilution factor greater system documentation for more information on ordering tests. As
sample: X than 1) needed, contact Technical Support for assistance.
Note: This event As an alternative, you can request the test on the DxI system (see
occurs only when Section 3.3 in the Operator's Guide).
the test is ordered by • Request the onboard dilution test for a sample that is not
an LIS or a DxC diluted.
integrated system.
• Request the parent test for a sample that is diluted.
Note: If other tests were requested for this sample, confirm that
they were tested with the correct dilution factor.
Pick and place • P&P (pick and place) Z-axis 1. Inspect instrument for fallen RVs and remove if found (see
dropped vessel after alignment Section 7.5 in the Operator's Guide).
pickup • P&P X-axis alignment 2. Initialize the system (see Section 4.2).
Pick and place • Ejector magnet failure 3. If initialization fails, repeat the initialization with the All
failed to detect • Ejector sensor failure Positions option selected for both the sample wheel and the
vessel after pickup analytical module.
• Intermittent cable connections
• Air line compromised
• Air valve failure
Pick and place still • Pick and place sensor 1. Initialize the system (see Section 4.2).
detects placed • Air pressure (kinked line, valve 2. Initialize the system again, with the All Positions option
vessel: X failure, low pressure, defective selected for the analytical module (see Section 4.2).
compressor) 3. Contact Technical Support for assistance if failures continue.
• Ribbon or power cable failure

C95318-AA
Pick and place • P&P Z-axis alignment Take one of the following actions:
vessel did not eject • P&P X-axis alignment • If this event occurs while troubleshooting using the options
• Ejector magnet failure available from the Diagnostics menu:
• Ejector sensor failure 1. Inspect instrument for fallen RVs and remove if found (see
• Intermittent cable connections
• Air valve failure 3. If initialization fails, repeat the initialization with the All
Positions option selected for both the sample wheel and
4. Contact Technical Support for assistance if failures
continue.
• If this event occurs while testing samples:
2. If initialization fails, repeat the initialization with the All
Positions option selected for both the sample wheel and
3. Repeat the test.
4. Contact Technical Support for assistance if failures
continue.
Pressure sensor for • Pressure sensor needs reference 1. Review event details (see Section 5.3) to identify which
reagent pipettor is curve reagent pipettors need reference curves.
not yet calibrated, so • Pressure sensor reference curve 2. Determine pressure sensor reference curves for reagent
tests cannot be run failed pipettors (see Section 4.5).
Pressure sensor for • Pressure sensor needs reference 1. Determine a pressure sensor reference curve for the sample
the sample pipettor curve pipettor (see Section 4.5).
is not yet calibrated, • Pressure sensor reference curve 2. Contact Technical Support for assistance if failures continue.
so aliquots cannot failed
be drawn
Pressure sensor for

the sample pipettor
is not yet calibrated,
so racks cannot be
loaded
Pump external • System command sent to move 1. Shut down the instrument and turn off the power switch (see
communications the pump, but Communication Section 6.3).
error failed due to a cable or board 2. Turn on the power switch to restart the instrument (see
issue Section 6.3).

C95318-AA
Pump motion failure • Pump belt 1. Initialize the system (see Section 4.2).
detected: X • Sticky piston 2. Prime the fluidics (see Section 4.3), selecting the fluidic
• MCC board system for the failed component.
• MCC motor cabling • For the sample pump, select the Sample Pipettor.
• Probe plugged or misaligned • If you cannot identify the component or fluidic system,
prime all fluidics.
• Kinked, damaged, or plugged
tubing 3. Contact Technical Support for assistance if failures continue.
QC manual rerun • Reagent pack used for original 1. If the reagent pack is not on board, load the reagent pack (see
cannot be run at this QC run empty or unloaded Section 2.7 in the Operator's Guide).
time • Reagent pipettor used for 2. If the reagent pack is empty or unavailable, QC cannot be
original QC run disabled rerun. Request a new QC (see Section 6.3 in the Operator's
Guide).
3. Locate the QC result on the Test Results screen (see
Section 4.3 in the Operator's Guide). Identify the pipettor
used.
4. Confirm that the reagent pipettor is enabled (see Section 2.3).
Enable the pipettor as needed.
QC result not • Previous device motion error 1. Review the Event Log and troubleshoot according to any
obtained - No value device motion error event with a date and time shortly before
stored this event.
2. Repeat the test (see Section 6.3 in the Operator's Guide) with
a freshly prepared control. If you need assistance or if the
problem persists, contact Technical Support.
Rack configuration • Rack ID not set up on system 1. Unload the unprocessed rack that caused the error (see
missing Section 3.4 in the Operator's Guide).
2. Add the rack ID to the system (see Section 2.3).
3. Load the rack again.

C95318-AA
Rack loading error • Rack in SPU is backward Clear all backward racks (see Section 6.5).
in the presentation
tray • Offload area is full, preventing 1. For a UniCel DxI 600 instrument, continue at step 2. For a
additional racks from moving UniCel DxI 800 instrument, open the side offload area cover,
through the SPU unload the racks, and then close the cover (see Section 3.4 in
the Operator's Guide).
Note: After removing racks from the side offload area, you
may need to wait 30 to 45 seconds before you can open the
SPU cover.
2. Open the SPU cover, and remove the racks from the front
offload area (see Section 3.4 in the Operator's Guide).
• Rack is damaged 1. Open the SPU cover and clear damaged or out of position
• SPU is Obstructed racks from the onload, offload, and sample presentation areas
of the SPU (see Section 6.5). Then close the cover and press
the Routine button.
• If the SPU cover does not open, the Clearing a Damaged or
Out of Position Rack procedure (see Section 6.5) contains
steps to take to open the cover.
• If the sample presentation tray is inside the sample aliquot
station, remove the rack (see Section 6.5).
2. Open the SPU cover again. Remove any other obstructions
from the SPU.
• If you cannot remove a rack or other obstruction in the area,
contact Technical Support for assistance.
3. If you opened the SPU lower panel in order to release the SPU
cover lock or clear a sample aliquot station obstruction, close
the SPU lower panel (see Section 6.2).
4. Close the SPU cover.
5. If you closed the SPU lower panel in step 3, initialize the
system (see Section 4.2).
6. Inspect the removed racks and load undamaged, properly
labeled racks for processing (see Section 3.4 in the Operator's
Guide).
Rack offload area is • Offload area is full, preventing 1. For a UniCel DxI 600 instrument, continue at step 2. For a
full additional racks from moving UniCel DxI 800 instrument, open the side offload area cover,
through the SPU unload the racks, and then close the cover (see Section 3.4 in
SPU cover.
• Offload rack sensor is sticky or 1. Clean the offload rack sensor (see Section 6.5).
damaged (UniCel DxI 800 2. If cleaning does not resolve the problem, contact Technical
only) Support for assistance.
Reading patient • LIS test request did not include 1. The Patient ID is required information in an LIS test request.
record: Patient ID the Patient ID The test must be requested again with the Patient ID.
missing 2. Share this information with the LIS Vendor and if needed,
refer the vendor to Technical Support for clarification.

C95318-AA
Reagent load door is • Reagent load door is open or 1. Open the reagent load door (see Section 2.7 in the Operator's
open obstructed during system Guide).
initialization 2. Inspect the tray for improperly seated reagent packs. If found,
• Reagent load tray interlock seat them properly in the tray.
switch failure 3. Close the reagent load door.
Reagent load tray is • Reagent packs not properly • If the door will not close, the latch may be in the locked
jammed seated position. Manually unlock the reagent load door before
closing (see Section 6.6).
• The reagent load door is
partially open • Contact Technical Support for assistance if the reagent load
door will not close.
• Defective reagent tray hardware
Reagent load tray: • Reagent load tray obstructed 1. Open the reagent load door (see Section 2.7 in the Operator's
Failure to read bar • Reagent load door hinge or Guide).
code at pack interlock issues 2. Inspect the tray for improperly seated reagent packs. If found,
position 1 seat them properly in the tray.
• Poor reagent pack bar code
• Clear plastic window scratched 3. Check the reagent pack bar codes for damage. If damaged,
remove the pack and load a new one.
• Bar code reader failed
4. Check for moisture on top of the reagent pack bar code labels.
• Reagent pack upside down
If found, wipe moisture off with clean, lint-free tissue.
Reagent load tray: • Poor reagent pack bar code 5. Close the reagent load door.
Failure to read bar • Clear plastic window scratched 6. If the problem is not resolved, initialize the system (see
code at pack Section 4.2).
position 2, 3, or 4
• Bar code reader failed
• Reagent pack upside down 7. Contact Technical Support for assistance if failures continue.
Reagent pack bar • Reagent pack loaded

code cannot be read improperly
• Defective bar code label on
reagent pack
• Defective barcode reader
• Tray motion error
Reagent pack • Reagent pack gripper or sensor 1. Remove reagent pack obstructions from inside the instrument
dropped or gripper failure (see Section 6.6).
sensors failed • Obstruction in the path of the 2. Contact Technical Support for assistance if failures continue.
reagent pack gripper
• Low air pressure
Reagent pack • X or Z motor coupler failed 1. Initialize the system with the Remap box selected (see
gripper assembly • X/Z pulley bearing Section 4.2).
motion failure • If initialization is successful, continue processing.
• Encoder failed
• Upper X guide shaft dirty or • If initialization is not successful, or if the error occurs
greasy again, continue with step 2.
• Obstruction in the path of the 2. Remove reagent pack obstructions from inside the instrument
reagent pack gripper (see Section 6.6).
• Damaged reagent slot 3. Contact Technical Support for assistance if failures continue.

C95318-AA
Reagent pack • Reagent pack was dropped 1. Initialize the system with the Remap box selected (see
gripper did not grip during movement within Section 4.2).
the reagent pack reagent storage • If initialization is successful, continue processing.
• Gripper mounting screws too • If initialization is not successful, or if the error occurs
tight again, continue with step 2.
• Low air pressure or leaks in the 2. Remove reagent pack obstructions from inside the instrument
air line (see Section 6.6).
• Broken gripper sensor cable 3. Contact Technical Support for assistance if failures continue.
• Reagent pack gripper or sensor
failure
• Loose bracket screw on bottom
of gripper
• Gripper bent
• Intermittent wire or sensor
Reagent pack • Reagent pack was dropped 1. Remove reagent pack obstructions from inside the instrument
gripper did not during movement within (see Section 6.6).
release the reagent reagent storage 2. Contact Technical Support for assistance if failures continue.
pack • Alignment issue
• Damaged reagent slot
• Gripper mounting screws too
tight
• Low air pressure or leaks in the
air line
• Broken gripper sensor cable
• Sensor failure
Reagent pack • Reagent pack gripper motion 1. Initialize the system with the Remap box selected (see
gripper home error Section 4.2).
position was not • Defective or loose sensor • If initialization is successful, continue processing.
found
• Defective encoder • If initialization is not successful, or if the error occurs
• Defective or loose drive belt again, continue with step 2.
2. Remove reagent pack obstructions from inside the instrument
(see Section 6.6).
Reagent pack • Reagent gripper or sensor error 1. Initialize the system with the Remap box selected (see
information is not • Database corrupted Section 4.2).
consistent 2. Continue processing.
• NVRAM or restore operation
issues • Contact Technical Support for assistance if failures
continue.

C95318-AA
Reagent pack • Empty reagent pack 1. Load a new reagent pack (see Section 2.7 in the Operator's
monitoring failed to Guide).
initialize 2. Contact Technical Support for assistance if failures continue.
• Air in tubing 1. Review event details (see Section 5.3) to identify which
reagent pipettors to prime.
2. Prime the reagent pipettors (see Section 4.2) indicated in the
Event Details.
• Calibration drift 1. Review event details (see Section 5.3) to identify which
reagent pipettors need reference curves.
2. Determine pressure sensor reference curves for reagent
pipettors (see Section 4.5).
• Pressure sensor failure Contact Technical Support for assistance.

• Malfunctioning pump
Reagent pack • Empty reagent pack 1. Review the Event Log (see Section 5.2) and troubleshoot
monitoring has according to any process monitoring failures with a date and
detected a reagent time shortly before this event.
dispense failure 2. If no failures were found in step 1, load a new reagent pack.
• Displaced reagent pack 1. Initialize the system with the Remap box selected (see
Section 4.2).
• Reagent pipettor, pressure 1. Review the Event Log (see Section 5.2) and troubleshoot
sensor, or pump problem according to any process monitoring failures with a date and
time shortly before this event.
Reagent pack • Corrupt INI file Contact Technical Support for assistance.
monitoring has • Nonvolatile memory fault
encountered a fault
condition
Reagent pack no • Pressure signal drift 1. Review event details (see Section 5.3) to identify which
longer usable due to reagent pipettors need reference curves.
process monitoring 2. Determine pressure sensor reference curves for reagent
failures pipettors (see Section 4.5).
• Empty reagent pack Contact Technical Support for assistance.

• Pack shared between
instruments
• Pressure sensor failure

C95318-AA
Reagent pipettor • Bubbles in sample vessel from 1. Prime the sample pipettor (see Section 4.3).
detects sample sample pipettor 2. Verify that sample container is in a rack configured for the
vessel fluid at • Air in fluidic lines container type being used:
unexpected height
• Insufficient volume in sample a. Select Sample Manager F1, then Views F1, then
vessel from sample pipettor Exceptions F4.
• Supply carriage alignment b. Note the rack ID of the sample that the error occurred on,
• Leaking fittings then clear the exception (see Section 3.1 in the Operator's
Guide).
• Defective ultrasonics board or
cable connections c. Remove the rack from the offload area of the SPU (see
Setup F8.
container.
Section A.2 in the Operator's Guide).
4. Repeat the test.
Reagent pipettor no • Pressure signal drift 1. Review event details (see Section 5.3) to identify which
longer usable due to reagent pipettors need reference curves.
process monitoring 2. Determine pressure sensor reference curves for reagent
failures pipettors (see Section 4.5).
• Pressure sensor failure Contact Technical Support for assistance.

Reagent pipettor • Ultrasonics board or cable 1. Repeat the test.
ultrasonics connections 2. If the failure is repeated, disable the named pipettor (see
failure: X • Ultrasonics transducer Section 2.3) and repeat the test again.
• Ultrasonics calibration 3. Contact Technical Support for assistance if you disabled a
• Pipettor tip torque pipettor to resolve the problem, or if failures continue.

C95318-AA
Reagent pipettor • Low vacuum: Vacuum pump or 1. Initialize the system (see Section 4.2).
wash tower X tubing failure; no fluid 2. Contact Technical Support for assistance if failures continue.
vacuum outside dispensed during wash
limits • High vacuum: Possible
obstruction in wash tower or
fittings
• Defective sensor on vacuum
interface board
• Defective DAQC board or
cables
Reagent storage • Defective reagent storage 1. Shut down the instrument and turn off the power switch (see
encoder is NAK interface board Section 6.3).
2. Turn on the power switch to restart the instrument (see
Section 6.3).
Reagent storage • Reagent pack gripper was 1. This event occurs while you are removing reagent pack
encoder moved moved manually while the obstructions from inside the instrument (see Section 6.6).
during dwell mode capacitor dwell time continued Complete that procedure.
Reagent storage • Reagent storage cover was
cover is off -- opened and has a defective
motors are disabled switch
Reagent supply • System has been without power 1. Initialize the system with the Remap box selected (see
internal status is for an extended period of time Section 4.2).
unknown. Remap • Loss of power to the interface 2. Continue processing.
required PCB • Contact Technical Support for assistance if failures
• System failure of reagent supply continue.
Reflex test for test X • An onboard dilution reflex test 1. An onboard dilution test cannot be requested for a manually
not added to was requested for a manually diluted sample. If a reflex test is still appropriate, request the
sample Y diluted sample (with a dilution parent test for this assay (see Section 3.3 in the Operator's
factor greater than 1) Guide).
Note: To use available diluted reserve volume instead of
loading fresh sample, order the test with your LIS.
2. For a test requested from the DxI console, load a fresh, diluted
sample (see Section 3.4 in the Operator's Guide).
• A dilution factor greater than 1 Warning: If the sample is not diluted, other tests run on this
was entered in error for a sample may have generated erroneous results.
sample that is not diluted 1. A reflex test for an onboard dilution cannot be run on a sample
with a dilution factor greater than 1. Request the onboard
dilution test again (see Section 3.3 in the Operator's Guide).
2. Load a fresh undiluted sample (see Section 3.4 in the
Operator's Guide). Make sure there is sufficient volume for
other requested tests and possible reflex tests (see Section A.2
in the Operator's Guide).

C95318-AA
Sample pick and • Bulk feeder failed to dispense 1. Inspect instrument for fallen RVs, and remove if found (see
place: Detected no RV into the supply carriage Section 7.5 in the Operator's Guide).
dilution vessel in the • P&P move error to the supply 2. Initialize the system (see Section 4.2).
supply carriage carriage 3. If initialization fails, repeat the initialization with the All
Sample pick and • P&P X- or Z-axis alignment to Positions option selected for both the sample wheel and the
place: Detected no the supply carriage analytical module.
reaction vessel in • P&P ribbon or power cable 4. Contact Technical Support for assistance if failures continue.
the supply carriage failure
Sample pick and • Ejector magnet failure

place: Detected no • Ejector sensor failure
sample vessel in the • Intermittent cable connections
supply carriage
• Air valve failure
Sample pipettor • Pressure sensor needs reference 1. Determine a pressure sensor reference curve for the sample
pressure sensor not curve pipettor (see Section 4.5).
calibrated • Pressure sensor reference curve 2. Contact Technical Support for assistance if failures continue.
failed

C95318-AA
Sample pipettor: RF • Rack or sample container 1. Verify that the sample container is in a rack configured for the
level sense failure configuration error container type being used:
• Inadequate sample volume a. Select Sample Manager F1, then Views F1, then
Exceptions F4.
b. Note the rack ID of the sample that the error occurred on,
then clear the exception (see Section 3.1 in the Operator's
Guide).
c. Remove the rack from the offload area of the SPU (see
Setup F8.
container.
Section A.2 in the Operator's Guide) and, as applicable, for
3. Verify that the sample container is properly aligned in the rack
(see Section 3.4 in the Operator's Guide).
4. Repeat the test.
• Sample pipettor motion failure 1. Check the Event Log for sample pipettor motion errors.
• RF level sense board failure 2. If errors are present, initialize the system (see Section 4.2).
• Leaking fittings 3. If not successful, shut down the instrument and restart it (see
• Defective sample pipettor Section 6.3).
• Defective COM Board 4. Repeat the test.
Sample Presentation • Rack label is damaged or 1. Open the SPU cover and remove the suspected rack from the
Unit bad rack improperly positioned offload area of the SPU (see Section 3.4 in the Operator's
barcode Guide).
2. Move the samples to a properly labeled rack (see Section 2.3).
3. Clear the rack label exception (see Section 3.1 in the
Operator's Guide).
4. Load the properly labeled rack and continue processing (see
• If the rack is successfully scanned, replace the label on the
removed rack.
• If the error continues, contact Technical Support.
• Bar code reader is out of Contact Technical Support for assistance.

alignment
• Bar code lens needs cleaning
• Bar code reader failure

C95318-AA
Sample Presentation • Offload area is full, preventing 1. For a UniCel DxI 600 instrument, continue at step 2. For a
Unit: Onload pusher additional racks from moving UniCel DxI 800 instrument, open the side offload area cover,
failed to move racks through the SPU unload the racks, and then close the cover (see Section 3.4 in
SPU cover.
• Rack in SPU is out of position 1. Open the SPU cover and clear damaged or out of position
or damaged racks from the onload, offload, and sample presentation areas
• RV is under the sample of the SPU (see Section 6.5). Then close the cover and press
presentation tray the Routine button.
from the SPU.
Guide).
• End of onload sensor is sticky, 1. Clean the SPU and end of onload sensor (see Section 6.5).
dirty, or broken 2. If cleaning does not resolve the problem, contact Technical
• Guide rails inside the SPU are Support for assistance.
sticky or dirty, causing racks to
be out of position
• Onload pusher is out of
alignment

C95318-AA
Sample Presentation • Rack in SPU is backward or 1. Open the SPU cover and clear damaged or out of position
Unit: Presentation damaged racks from the onload, offload, and sample presentation areas
tray motor failed to • RV is under the sample of the SPU (see Section 6.5). Then close the cover and press
move racks presentation tray the Routine button.
from the SPU.
Guide)
• Presentation tray home sensor is Contact Technical Support for assistance.

dirty
• Presentation tray lead screw is
binding or worn
• Electrical failure
• MCC board or cabling failure
Sample presentation • Debris between racks 1. Open the SPU cover and clear damaged or out of position
unit: Rack detection • Damage to the rack racks (see Section 6.5) from the sample presentation areas of
or rack movement the SPU.
error
• Onload sensor error
• Onload pusher motion error
Guide).
3. Contact Technical Support if failures continue.
Sample Presentation Troubleshoot according to the "Rack loading error in the presentation tray" event.
Unit Remove
rack(s) on
Presentation Unit
Tray
Sample vessel in • Software issue 1. Shut down the instrument and turn off the power switch (see
wrong reagent • NVRAM issue Section 6.3).
carriage position 2. Turn on the power switch to restart the instrument (see
Section 6.3).

C95318-AA
Sample vessel not • Sample not found for 1. Review the Event Log and troubleshoot according to any
found on sample processing device error event with a date and time shortly before this
wheel or in reagent event.
carriage 2. Repeat the test.
Sample wash tower • Low vacuum: Vacuum pump or 1. Initialize the system (see Section 4.2).
vacuum outside tubing failure; no fluid 2. Contact Technical Support for assistance if failures continue.
limits dispensed during wash
• High vacuum: Possible
obstruction in wash tower or
fittings
• Defective sensor on vacuum
interface board
• Defective DAQC board or
cables
Security tool is Security tool is disabled on the PC Contact Technical Support for assistance.
disabled on the X or Instrument
Substrate bottle • Bottle expired during substrate 1. Verify that both substrate bottles are present on the system
switch failed: New switch (see Section 2.2 in the Operator's Guide).
bottle cannot be • Defective bottle present sensor 2. Check to see if either bottle is expired or empty.
used
• Defective interface board 3. Replace bottles as needed.
Substrate bottle 4. Initialize the system (see Section 4.2).
switch failed: 5. Prime the substrate 6 cycles (see Section 4.3).
System cannot
detect used bottle 6. Contact Technical Support for assistance if failures continue.
Substrate dispense • Calibration not performed after 1. Prime substrate 10 cycles with Calibrate Drawback selected.
failure: Air in substrate probe replacement For more information, see Section 4.3.
fluidics line or other • Loose fitting to substrate 2. Contact Technical Support for assistance if failures continue.
pump-related stopper, to bottle valve, to
dispense failure probe, or to valve
• Substrate seal
• LED board
• Constricted tubing
Substrate expired • Substrate expiration date has 1. Replace the substrate bottle with a fresh bottle (see Section 2.2
passed in the Operator's Guide).
• Substrate bottle has been on 2. Continue normal operation. If you need assistance or if the
board the instrument for more problem persists, contact Technical Support.
than 14 days

C95318-AA
Substrate load door • Substrate bottle not installed 1. Check substrate load door for obstructions (see Section 2.2 in
did not close within properly the Operator's Guide).
time limit • Door blocked from closing 2. Clear any obstructions and reposition substrate bottle to allow
• Defective/broken door or sensor door to close.
• Low air pressure 3. Contact Technical Support for assistance if failures continue.
• Defective valves or electrical
parts
Substrate probe • Substrate drawback not 1. Prime substrate 10 cycles with Calibrate Drawback selected
drawback calibrated (see Section 4.3).
calibration failed, so • Defective substrate pump, 2. Contact Technical Support for assistance if failures continue.
tests cannot run valve, or probe
Substrate probe • System interruption during
drawback is dispense operation
compromised, so
tests cannot run
Substrate probe
drawback is not
calibrated, so tests
cannot run
Subsystem unable to • Motor failure 1. Initialize the system (see Section 4.2).
home: X • Sensor failure 2. Contact Technical Support for assistance if failures continue.
• Obstruction
System Check result • Hardware failure 1. Be sure all maintenance routines have been performed (see
out of range • Reagent failure Section 7.1).
2. Repeat the System Check routine. Be sure to follow the
instructions as written in the Running System Check Routines
procedure in Section 4.4: System Check Routines.
3. If System Check results are still out of range, display, print,
and review System Check result data (see Section 4.4).
4. Contact Technical Support for assistance.
Temperature • Thermistor 1. Shut down the instrument and turn off the power switch (see
controller failure • Electrical failure Section 6.3).
• Hardware failure 2. Turn on the power switch to restart the instrument (see
Section 6.3).
3. Delay system processing until temperatures on the
Maintenance Review screen (see Section 7.1) come into range.
4. Contact Technical Support for assistance if temperatures do
not come into range or if failures continue.

C95318-AA
Temperature X out • One or more thermal zone 1. Delay system processing until thermal zone temperatures on
of limits: Y temperatures are out of limits the Maintenance Review screen (see Section 7.1 in the
Operator's Guide) come into range.
2. If the Upper Cabinet temperature is out of range, perform steps
a. and b. Otherwise, proceed to step 3.
a. Check the operating environment temperature of the system
and make sure it is within range (see Section A.1).
Note: In addition to room temperature, factors such as air
circulation, heat sources near the system, and direct sunlight
can influence the operating environment temperature.
b. If the operating environment temperature is out of range,
make adjustments as needed.
3. Contact Technical Support for assistance if temperatures do
not come into range or if failures continue.
Ultrasonics level • Bubbles in sample vessel from 1. Prime all fluidics components (see Section 4.3).
sense failure sample pipettor 2. Verify that sample container is in a rack configured for the
• Insufficient volume in sample container type being used:
vessel from sample pipettor a. Select Sample Manager F1, then Views F1, then
• Leaking fittings Exceptions F4.
• Reagent pipettor tip worn b. Note the rack ID of the sample that the error occurred on,
• Ultrasonics calibration then clear the exception (see Section 3.1 in the Operator's
Guide).
• Defective ultrasonics board or
cable connections c. Remove the rack from the offload area of the SPU (see
• Defective COM board
Setup F8.
container.
Section A.2 in the Operator's Guide).
4. Repeat the test.

C95318-AA
Unable to The system is configured to automatically rerun failed tests. However, the test cannot be rerun for one
automatically rerun of the following reasons/possible causes:
test X for sample Y:
Z • Dilution factor is not 1 When there is insufficient sample on board, manual dilution tests
cannot be rerun from the work pending list.
Note: Z is one of the
possible causes for 1. Request the test again (see Section 3.3 in the Operator's
this event. Guide).
2. Load a fresh, diluted sample.
• Confirmatory tests cannot be Confirmatory tests must be aspirated at the same time as the
rerun original qualitative test, and there was insufficient sample
remaining on board.
1. Request the qualitative and confirmatory tests again (see
2. Load a fresh sample.
• Test name or units changed, or Because the configuration of the test changed from the time it
the test is no longer enabled was originally requested, the test as previously requested cannot
be rerun.
• If appropriate, request the test again (see Section 3.3 in the
Operator's Guide) after confirming the change to the test set
up (see Section 3.3).
Unable to run • One or more reagent pipettors 1. Enable all reagent pipettors (see Section 2.3).
cleaning operation. are disabled 2. Contact Technical Support for assistance if failures continue.
All pipettors are not
available
Unable to start • Obstruction 1. Inspect instrument for fallen RVs, and remove if found (see
subsystem • Defective components Section 7.5 in the Operator's Guide).
• Device motion error 2. Initialize the system (see Section 4.2).
Unauthorized An unauthorized attempt was Do not modify system software files except as directed by the
modification of made to modify a system software system documentation or a Beckman Coulter technical support
application file representative.
prevented 1. Close the files and folders you were attempting to change.
2. Continue normal operation of the system.
Note: If you received this event message while following the
directions in your system documentation, contact Technical
Support.
Vessel not present • P&P alignment to failing device 1. Inspect instrument for fallen RVs, and remove any found (see
for Pick and Place • Defective P&P sensor Section 7.5 in the Operator's Guide).
(P&P) 2. Initialize the system (see Section 4.2).
• Device motion error
Wash buffer flow • Calibration never performed 1. Calibrate the wash buffer flow sensor (see Section 4.5)
sensor is not yet • Calibration failed 2. Contact Technical Support for assistance if failures continue.
calibrated, so tests
cannot be run

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Wash buffer • Wash buffer supply 1. Open the wash buffer supply drawer.
reservoir is empty or tubing/fitting not properly 2. Check the bulk wash buffer containers to verify that adequate
lower sensor failed connected supply exists. If not, change replace the empty containers (see
• Empty wash buffer bottle Section 2.3 of the Operator's Guide).
• Defective or uncalibrated wash 3. Inspect the wash buffer supply drawer and containers for
buffer weight sensors damaged or missing draw tubes, loose caps, or kinked tubing.
• Defective fluid level control For more information, see the Inspecting the Wash Buffer
pump Supply Drawer procedure in Section 7.5: Test Interval
Maintenance: 10,000 Tests of the Operator's Guide.
• Defective float sensor
5. If initialization is successful, prime all fluidic components (see
Section 4.3).
6. If initialization is not successful, or if failures continue,
Wash buffer transfer • Peristaltic pump tubing not 1. Initialize the system (see Section 4.2).
pump: Motion seated correctly 2. Prime the fluidics with the reagent pipettors selected (see
failure • Peristaltic pump head, sensor, Section 4.3).
or motor failure 3. Contact Technical Support for assistance if failures continue.
Wash buffer transfer
pump: Motion • Loose or defective electrical
failure during initial connections
movement • Broken motor shaft on the
transfer pump
• Wash buffer transfer pump
failure
Wash carousel: Physical issues preventing the 1. Initialize the system with the All Positions option selected for
Motion error wash carousel from rotating: the analytical module (see Section 4.2).
• Debris, duckbill valve, or 2. Contact Technical Support for assistance if failures continue.
damaged vessel in the wash
carousel
• Wash buffer buildup
• Loose or misplaced
analytical module covers
• Defective idler bearings
• Wash carousel drive motor
or home position issues
• Wash P&P or incubator P&P
vessel placement issues
• Gripper/spinner vessel
ejection issues
• Air leak or low air pressure
Electrical issues:
• Loose connections, damaged
cables, defective MCC 7
PCB, defective sensor
• Corroded or defective
encoder

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Wash collar vacuum • Duck bill valve 1. Replace the duck bill valve (see Section 7.4 in the Operator's
failure • Vacuum pump 3 failure Guide).
• Wash collar failure 2. If the problem persists, remove and install a clean aspirate
probe 1 (see Section 7.5 in the Operator's Guide).
• Vacuum sensor failure
• Vacuum tubing partial
obstruction
Wheel or carousel • Wash carousel or wash pick and 1. Initialize the system (see Section 4.2) according to the
not in expected place out of position subsystem that failed.
position: X • Incubator or incubator pick and • For the wash carousel, wash pick and place, incubator, or
place out of position incubator pick and place, select the All Positions option for
• Sample wheel or sample pick the analytical module.
and place out of position • For the sample wheel or sample pick and place, select the
All Positions option for the sample wheel.
• If you cannot identify which subsystem failed, select the All
Positions option for the analytical module and the sample
wheel.

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UniCel DxI Reference Manual 6: System Support Procedures
6
System Support Procedures
6.1 System Support Procedures Overview ...................................................... 6-3
6.2 Instrument Cover Procedures ..................................................................... 6-4
Opening and Closing the Main Upper Covers .................................................. 6-4
Opening and Closing the SPU Lower Panel ..................................................... 6-8
Releasing the SPU Cover Lock....................................................................... 6-12
6.3 Shut Down and Restart Procedures .......................................................... 6-14
Shutting Down the PC..................................................................................... 6-15
Restarting the PC and UI Software ................................................................. 6-17
Shutting Down the Instrument ........................................................................ 6-18
Shutting Down the System for an Extended Period........................................ 6-19
Restarting the Instrument ................................................................................6-20
Restarting the System After an Extended Shut Down .................................... 6-21
6.4 Fluidics Support Procedures ...................................................................... 6-24
Decontaminating the Substrate System........................................................... 6-24
Cleaning a Sample Probe ................................................................................6-30
Replacing a Sample Probe .............................................................................. 6-36
6.5 Rack and SPU Support Procedures .......................................................... 6-38
Clearing a Backward Rack.............................................................................. 6-38
Clearing a Damaged or Out of Position Rack................................................. 6-41
Removing a Rack Obstructing the Sample Aliquot Station............................ 6-43

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6: System Support Procedures UniCel DxI Reference Manual
Cleaning the SPU and Sensors........................................................................ 6-47
6.6 Reagent Pack Movement Support Procedures .....................................6-50
Removing a Reagent Pack Obstruction from Inside the Instrument............... 6-50
Manually Unlocking the Reagent Load Door ................................................. 6-56

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UniCel DxI Reference Manual 6.1: System Support Procedures Overview
6.1
System Support Procedures
Overview
If you experience a system problem while operating your UniCel DxI instrument, you
can perform specific support procedures to isolate or correct the problem. Many
support procedures should only be performed if you are directed to do so by the
system documentation or by a technical support representative. These restricted
procedures include the restriction in the procedure introduction.
A few support procedures are commonly performed, such as opening covers to

maintain your instrument or restarting the system to install software. Regardless of the
frequency with which you perform a procedure, regularly review the written
procedures, including their cautions for protecting the instrument from damage, and
their warnings for ensuring your personal safety.
Be sure you understand all of the instructions in a support procedure before you begin
working on the instrument. If you have any questions about a support procedure,
contact Technical Support.

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6.2: Instrument Cover Procedures UniCel DxI Reference Manual
6.2
Instrument Cover Procedures
Open the instrument covers to inspect specific areas or devices within the instrument.
The instrument cover procedures explain how to properly open and close instrument
covers to avoid causing personal injury or damage to the instrument.
Open a cover only if you are directed to do so by a technical support representative or

by the system documentation.
WARNINGS
• Never wear exposed metal that can come into contact with electrical
components of the instrument.
• You will come in contact with potentially infectious materials during these
procedures. Handle and dispose of biohazard materials according to proper
• If you have difficulty locating the components listed in any instrument cover
procedure, contact your technical support representative.
Opening and Use these procedures to open or close the left or right main upper cover.
Closing the
Main Upper WARNINGS
Covers • Never wear exposed metal that can come into contact with electrical
• You will come in contact with potentially infectious materials during these

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UniCel DxI Reference Manual 6.2: Instrument Cover Procedures
NOTES
• When you open a main upper cover, the power to the upper cabinet is shut off.
• Opening the main upper covers generates the Main cover is open event. If the
BNexGenAUEvent(Unknown ... event immediately follows the Main cover
is open event, the BNexGenAUEvent(Unknown... event may be ignored. It
has no impact on instrument operation or test results.
Preparing to Open a Main Cover
CAUTION
Opening the covers abruptly shuts off power to the upper cabinet, and may cause
damage if the system is not in a proper mode and the user interface is not
displaying the correct screen. Always prepare the instrument before opening a
main upper cover.
NOTE
Skip this procedure if the power to the instrument is turned off.
From the Diagnostics menu, select Device Diagnostics F4 to display the Device
Diagnostics screen. You can now open one or both of the main upper covers.
Opening the Left Main Upper Cover
WARNINGS
1. Grasp the lower corners of the closed left main upper cover with both hands (see
Figure 6-1).
2. Gently lift the cover until the cover is completely open.
NOTE
A cover is completely open when the internal air cylinders hold the cover in
place.

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2 3
6
5
1
4
UniCel DxI 800 Instrument

2125A.eps
2 3
6 5
1 4
UniCel DxI 600 Instrument

2125B.eps
1 Lower corners of the left main upper cover

2 Left main upper cover
3 Right main upper cover
4 Lower right corner of the right main upper cover
5 Substrate load area (hidden on the DxI 600)
6 Lower left corner of the right main upper cover
Figure 6-1 UniCel DxI Instrument Upper Main Covers

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Opening the Right Main Upper Cover
WARNINGS
1. Grasp the lower right corner of the closed right main upper cover with your right
hand (see Figure 6-1).
2. Gently lift the cover approximately 2-3 inches (5.1-7.6 cm).
3. While you continue to hold the lower right corner with your right hand, grasp the
lower left corner with your left hand.
4. Gently lift the cover until the cover is completely open.
NOTE
A cover is completely open when the internal air cylinders hold the cover in
place.
Closing the Main Upper Covers
WARNINGS
System Mode: Not Ready
1. With both hands, grasp the lower corners of the open left or right main upper
cover (see Figure 6-1).
2. Gently lower the cover until it rests completely against the main body of the
instrument. Keep your fingers away from the cover corners while lowering the
cover.
3. Initialize the system. For more information, see Section 4.2: Initialize System.

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Opening and Use this procedure to open the sample presentation unit (SPU) lower panel. You may
Closing the need to open the SPU lower panel if one of the following conditions occur.
SPU Lower
• Unexpected loss of power
Panel
• Rack jam in the sample aliquot station
• Reagent pack jam or gripper failure in the reagent storage area.
Required Materials
• 3/16-inch hex wrench
• 5/32-inch hex wrench, if you need to loosen the screw beneath the vessel
hopper
Opening the SPU Lower Panel

Use this procedure to open the SPU lower panel.
WARNINGS
• If you have difficulty locating the components listed in this procedure,
contact your technical support representative.
1. If the system is in the Paused or Running mode, wait for the system to enter the
Ready or Not Ready mode.
NOTE
It may take up to two hours for the system to produce results for the samples that
are in process. If you begin troubleshooting before the system has completed
processing, you may lose the tests in progress and will need to load samples
again.
2. Remove the substrate bar code reader from its holder and set it on the PC cart,
away from the SPU lower panel opening.
3. Select Device Diagnostics F4 from the Diagnostics Menu, and then open the left
main upper cover. For more information, see the Opening and Closing the Main
Upper Covers procedure.

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4. Locate the hex bolt above the SPU cover and to the left of the Routine and STAT
buttons (see Figure 6-2).
2277B.eps
1 System status panel (UniCel DxI 800 instrument only, not all systems are
equipped)
2 Routine and STAT buttons, and the onload pusher motion indicator
3 3/16-inch hex bolt
Figure 6-2 SPU Cover Hex Bolt, Under the Left Main Upper Cover
(UniCel DxI 800 Instrument Shown)
5. Loosen and remove the hex bolt with a 3/16-inch hex wrench. Set the hex bolt in
a safe area so it is not misplaced.
6. Place your finger in the indentation between the wash buffer supply drawer and
the lower right door. Open the lower right door by swinging it to the right.

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7. Locate the SPU holding pin that keeps the SPU lower panel in place (see Figure
6-3).
1 3
2
2252A.eps
1 SPU holding pin

2 Instrument power switch
3 Lower right door (open)
Figure 6-3 SPU Holding Pin Location
8. Lift and hold the SPU holding pin, then carefully swing the SPU lower panel
away from the instrument a few inches and release the holding pin.
• If the panel resists movement, make sure there is proper clearance. The SPU
area along the left side of the instrument slides toward the back of the
instrument as the front of the SPU swings out. Watch the left side of the SPU
and ensure that no personnel, material, or other items obstruct this movement.
• If the panel has proper clearance but still resists movement, follow the steps in
the Loosening the Hex Screw Beneath the Vessel Hopper procedure.
9. If you are opening the SPU lower panel to release a locked SPU, continue with
the Releasing the SPU Cover Lock procedure. Otherwise, continue
troubleshooting according to the procedure that directed you to open the SPU
lower panel.

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Loosening the Hex Screw Beneath the Vessel Hopper

In order to open the SPU lower panel, the hex screw beneath the vessel hopper must
be loosened. Once it is loose, the screw does not need to be tightened again, but
should not be removed from the system.
1. Locate the hex screw on the base plate beneath the vessel hopper (see Figure 6-4).
2278B.eps
1 Vessel hopper (top view)

2 Circuit board beneath the vessel hopper (top view)
3 5/32-inch hex screw (top view)
4 SPU cover (top view)
Figure 6-4 SPU Lower Panel Hex Screw, Under the Left Main Upper Cover
CAUTION
When reaching beneath the vessel hopper, be careful not to touch the circuit
board. You can disturb important electronic connections if you brush against the
board.
2. Loosen (do not remove) the hex screw one to two full turns with a 5/32-inch hex
wrench.

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Closing the SPU Lower Panel

This procedure begins with the left main upper cover, the SPU lower panel, and the
lower right door open.
System Mode: Not Ready
1. Face the instrument and carefully push the SPU lower panel until the panel is near
the SPU holding pin.
2. Lift and hold the SPU holding pin, and then push the SPU lower panel into place.
• If the SPU lower panel does not move into position, you may need to loosen
the hex screw under the bulk feeder a quarter turn more. For more
information, see the Loosening the Hex Screw Beneath the Vessel Hopper
procedure.
3. When the panel is in place, release the holding pin to secure the panel to the
instrument frame.
4. Close the lower right door.
5. Return the hex bolt and tighten it with a 3/16-inch hex wrench.
6. Close the left main upper cover and initialize the system. For more information,
see the Opening and Closing the Main Upper Covers procedure, and see
Section 4.2: Initialize System.
7. Return the substrate bar code reader to its holder.
8. Continue troubleshooting according to the procedure that directed you to close

the SPU lower panel.
Releasing the Use this procedure to release the sample presentation unit (SPU) cover lock. You may
SPU Cover need to release the cover lock to open the SPU when one of the following conditions
Lock occur.
• Unexpected loss of power
• Rack jam in the sample aliquot station
This procedure begins with the left main upper cover, the SPU lower panel, and the
lower right door open. For more information, see the Opening and Closing the Main
Upper Covers, and the Opening and Closing the SPU Lower Panel procedures.

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1. While facing the instrument, carefully swing the SPU lower panel to the left until
you can reach the SPU cover lock lever located on the back of the panel.
• On the UniCel DxI 800 instrument, the lever is near the open edge of the
panel (see Figure 6-5).
• On the UniCel DxI 600 instrument, the lever is inside a cutout, near the
middle of the panel.
2279C.eps
Figure 6-5 SPU Cover Lock Lever, on the Back of the SPU Lower Panel
2. Face the back of the SPU lower panel and slide the lever to the right to release the
cover lock.
3. Continue troubleshooting according to the procedure that directed you to release

the SPU cover lock.

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6.3: Shut Down and Restart Procedures UniCel DxI Reference Manual
6.3
Shut Down and Restart
Procedures
As you operate the UniCel DxI system, you occasionally need to shut down the PC,
the instrument, or both. The shut down and restart procedures explain how to properly
shut down and restart the system.
CAUTION
If you do not follow these procedures, you may damage the instrument or
corrupt the system database.
Shut down and restart the PC if you are directed to do so by a technical support
representative or by the system documentation.
NOTE
If you shut down and restart the PC, the instrument continues processing samples.
The test data is sent automatically when the PC re-establishes communication
with the instrument.
Restarting an instrument after shut down resets the software, and returns all
instrument devices to their home positions.

C95318-AA
UniCel DxI Reference Manual 6.3: Shut Down and Restart Procedures
Shutting Down There are two methods for shutting down the PC.
the PC • Using the user interface (UI) software
• Using the computer keyboard
Use the UI software for standard shut downs. Use the keyboard only when the UI is
not available. If you use the computer keyboard to shut down the PC, you may require
additional assistance from Technical Support to clean up your database.
NOTES
• Depending on the version of your PC, you may need the system password to
restart the PC. If you do not know the password, contact the lab supervisor.
• If you are shutting down the PC and the instrument at the same time, shut
down the instrument first. For more information, see the Shutting Down the
Instrument procedure.
Shutting Down the PC with the UI Software

Use this procedure to shut down the PC with the UI software.
NOTES
• In emergencies you can shut down the PC when the instrument is in the
Running or Paused mode.
1. From the Configure menu, select PC Admin F7 to display the PC Admin screen.
2. From the PC Admin screen, select System Admin F8 and then select Shut Down
PC F1 to display the UniCel DxI Shut Down window.
WARNING
Do not select the Shut down the instrument software box.
3. Select Yes F1.
4. Select OK F1 to shut down the PC software.

 (Optional) To shut off the power to the PC, press and hold the power switch for at
least 10 seconds (see Figure 6-6). Wait at least 20 seconds before restarting the
PC. For more information, see the Restarting the PC and UI Software procedure.

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1054B.eps
Figure 6-6 PC Power Switch Symbol
Shutting Down the PC Using the Computer Keyboard

If you do not have access to the UI software, use this procedure to shut down the PC
with the computer keyboard.
NOTES
• Use the computer keyboard to shut down the UI if you have no alternative.
• If the keyboard does not respond during the performance of this procedure,
shut down the PC by turning off the power. Press and hold the power switch
for at least 10 seconds (see Figure 6-6). Then wait at least 20 seconds before
restarting the PC. For more information, see the Restarting the PC and UI
Software procedure.
System Mode: Not Applicable
1. Take one of the following actions:

• If you know the software operating system on your DxI system PC, proceed to
the appropriate instructions in the table below.
• To determine the software operating system on your DxI system PC, press the
Windows® key [®] on the computer keyboard, or press [Ctrl] + [Esc].
For PCs operating with Windows® 8e, the Windows® 8e Start screen is
displayed. The image below (see Figure 6-7) is visible in the upper left portion
of the screen. If the Windows® 8e Start screen is not displayed, your system is
operating with Windows® XPe.
2379A.bmp
Figure 6-7 Windows® 8e Start Screen

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Windows® XPe Windows® 8e
2. Simultaneously press the [Ctrl], [Alt], and 2. If necessary, press the Windows® key [®] on
[Delete] keys on the computer keyboard. the keyboard to display the Start screen.
3. Select Shut Down. 3. Move the mouse cursor to the lower-right corner
4. Select one of the shut down options, depending of the Start screen.
upon whether you want to immediately restart A narrow vertical panel of icons is displayed
the PC software. along the right side of the screen.
5. Select OK. 4. Select the Settings icon.
2380A.bmp
The Settings panel is displayed.
5. Select the Power icon.
6. Select Shut down or Restart, depending upon

whether you want to immediately restart the PC
software.
7. If a screen displays with a button named Shut

down anyway or Restart anyway near the
bottom of the screen, select the button.
Restarting the Use this procedure to restart the PC and the UI software.
PC and UI
Software
1. Restart the PC or the UI software.
• If the power to the PC is not off, select Restart in the Shutdown Computer
window to restart the UI software.
• If the power to the PC is off, locate the power switch (see Figure 6-6) and
press and hold the switch for at least 2 seconds to turn the power on and restart
the UI software.
 Depending on the version of your PC, you may need the system password to
2. Wait until the UniCel DxI Main Menu is displayed. If this procedure fails to
restart the PC or the UI software, contact Technical Support.
3. If the PC was shut down for more than 30 minutes, and the instrument was
processing tests, it may take a few minutes for the instrument to send test results
to the PC. Do not use the system until the PC receives all of the test results.

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NOTE
To be sure that all test results are sent, display the Test Results screen and filter
the results by completion time. For more information, see Section 4.2: Test
Result Filters in the Operator's Guide. Watch the Result and Comp. Time
columns for the system to stop sending results. If you have any questions, contact
Technical Support.
4. Continue normal operation.
Shutting Down In some circumstances, it may be necessary to shut down the instrument and not the
the Instrument PC. Shut down the instrument only if instructed to do so by a technical support
representative or by the system documentation.
NOTES
password, contact your lab supervisor. For more information about
passwords, see Section 2.2: System Setup.
• If you are shutting down the PC and the instrument at the same time, shut
down the instrument first.
• Shutting down the instrument turns off the refrigeration in the reagent storage
chamber and other areas.
1. From the Configure menu, select PC Admin F7 to display the PC Admin screen.
2. From the PC Admin screen, select System Admin F8 and then select Shut Down
Instrument F2 to display the Shut Down Instrument Software window.
NOTE
If there is no connection between the UI software and your UniCel DxI
instrument, a message is displayed informing you that the connection was lost.
The system cancels the shut down operation. If this occurs, contact Technical
Support before attempting to shut down the instrument with the power switch.
4. When the software has shut down, a message is displayed instructing you to turn
off the instrument power switch. Select OK F1 to exit the message window.
5. The instrument power switch is behind the lower right door as you face the
instrument. Open the door and locate the power switch (see Figure 6-3).

C95318-AA
6. Press the lower part of the switch to turn the power off (O position).
The system mode area of the system software screen turns red, but no system
mode is displayed.
7. Wait at least 20 seconds to restart the instrument. For more information, see the
Restarting the Instrument procedure.
Shutting Down If you plan to have the instrument moved, or if power to the system will be turned off
the System for for an extended period of time (more than five days), shut down the entire UniCel DxI
an Extended system. Before moving or shutting down the system, contact Technical Support to
Period confirm your strategy.
WARNINGS
• If you plan to have the instrument moved, make sure that the new location is
properly plumbed. Reagents, calibrators, and controls used with the system
may contain small quantities of sodium azide preservative. Sodium azide
preservative may form explosive compounds in metal drain lines. Refer to
National Institute for Occupational Safety and Health Bulletin: Explosive
Azide Hazards (8/18/76).
NOTE
Shutting down the instrument turns off the refrigeration in the reagent storage
chamber and other areas.
1. Run the Special Clean routine. For more information, see Section 7.2: Daily
Maintenance in the Operator's Guide.
2. Remove all racks and sample containers from the onboard and offboard areas of
the sample presentation unit (SPU). For more information, see Section 3.4:
Loading and Unloading Racks in the Operator's Guide.
3. Unload and refrigerate all of the reagent packs. For more information, see
Section 2.7: Reagent Supplies in the Operator's Guide.
4. Change the bulk liquid waste containers if your system uses them. For more
information, see Section 2.5: Liquid Waste in the Operator's Guide.

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5. Change the solid waste container. For more information, see Section 2.6: Solid
Waste in the Operator's Guide.
6. Remove the on-board substrate bottles and replace with empty substrate bottles.
Discard the in-use substrate bottle in the biohazard waste. Refrigerate the second
bottle if it has not been used. For more information, see Section 2.2: Substrate in
7. Remove and refrigerate the bottles equilibrating in the substrate equilibration area
(UniCel DxI 800 instrument: see Figure 2-10 in Section 2.2: Substrate of the
Operator's Guide; UniCel DxI 600 instrument: see Figure 2-11).
8. Shut down the PC and the instrument. This includes shutting off the power switch
for the instrument and the PC. For more information, see the Shutting Down the
PC and the Shutting Down the Instrument procedures.
Restarting the Use this procedure to restart the UniCel DxI instrument if the power to the instrument
Instrument is off.
To re-establish communication between the instrument and console PC, it is

necessary to restart the console PC after restarting the instrument. Consequently, this
procedure contains steps to verify that the console PC is off before restarting the
instrument, and to restart the console PC after restarting the instrument.
CAUTION
Do not select any buttons on the PC touchscreen or press any keys while the
instrument restarts and initializes. After you start this procedure, the system
pauses for approximately two minutes as it resets the software. Then the system
enters the Not Ready mode and begins the system initialization process.
NOTE
If the PC is on, the system mode area of the system software screen is red, but no
system mode is displayed.
1. Verify that the console PC is shut down. For more information, see the Shutting
Down the PC procedure.
2. Verify that the main upper covers are closed.
3. Locate the instrument power switch behind the lower right door as you face the
instrument (see Figure 6-3).
4. Press the top part of the switch to turn the power on ( | position) and then wait 90
seconds.

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5. Press and hold the console PC power switch for two seconds to turn power on and
start the UI software (see Figure 6-6).
6. The system restarts and initializes.
Observe the following sequence of events.
• During system initialization, the system homes mechanical devices and
displays a flashing message in the system mode area. When most system
devices complete initialization, the system enters the Ready mode.
• While in the Ready mode, the system continues to initialize any remaining
devices and displays a flashing message in the system mode area. When this
message disappears, system initialization is complete.
7. Verify that the system is in the Ready mode and no message is displayed in the
system mode area. If the instrument does not initialize successfully, contact
Technical Support.
8. Wait for the system to restore the internal temperatures. If the instrument was
shut down for a short period of time, it will take 15-20 minutes for the system to
restore the internal temperatures. Do not load samples on the instrument until all
temperature zones are in range. For more information, see the Maintenance
Review Screen topic in Section 7.1: Maintenance Overview of the Operator's
Guide.
9. Continue normal operation.
Restarting the Use this procedure to restart the UniCel DxI system following an extended shut down.
System After
an Extended WARNINGS
Shut Down • You will come in contact with potentially infectious materials during this
• Wash buffer contains a preservative which may cause sensitization by skin
contact. After contact with skin, wash immediately with soap and water.
Wear suitable gloves.
1. Restart the PC and the UI software. For more information, see the Restarting the
PC and UI Software procedure.
2. Restart the instrument. For more information, see the Restarting the Instrument
procedure.

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NOTE
Wait for the system to restore the internal temperatures. Because the system was
shut down for an extended period of time, it will take up to one hour for the
system to restore the internal temperatures. Do not load samples on the
instrument until all temperature zones are in range.
3. Verify that the wash buffer supply is adequate. If necessary, change the bulk
wash buffer containers. For more information, see Section 2.3: Wash Buffer in
4. Empty the solid waste container if it is full. If your system uses on-board bulk
liquid waste containers, empty them if they are full. For more information, see
Section 2.6: Solid Waste and see Section 2.5: Liquid Waste in the Operator's
Guide.
5. Check the RV supply. If necessary, add more RVs. For more information, see
Section 2.4: Reaction Vessels in the Operator's Guide.
6. Load new substrate bottles. For more information, see Section 2.2: Substrate in
NOTE
Before you load substrate onto the instrument, the bottles must equilibrate at
room temperature for the time specified in the reagent instructions for use. For
more information, see the reagent instructions for use.
Fluidics window.
8. Select Select All F3. All of the components are selected for priming.
9. Enter the following number of priming cycles in the Cycles Requested field for
each component:
• Substrate In Use - Enter 6 cycles.
• Sample Pipettor - Enter 5 cycles.
• Aspirate 1 & Dispense Probes - Enter 3 cycles.
• Reagent Pipettors #1to #4 - Enter 4 cycles in each box.
10. Select Start Priming F2. When the priming is complete, a message is displayed.
11. Select OK F1 to exit the message window.
12. Select Done F1 to exit the Prime Fluidics window.

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13. Depending upon how long the system has been shut down, perform the following
procedures.
> 2 Weeks 1-2 Weeks < 1 Week
10,000 Test Interval Maintenance X

Special Clean Routine X X X
All System Check Routines X X
Run QC X X X
Table 6-8 Procedures for Restarting the System After

an Extended Shut Down
For more information, see the following procedures.

• For information about 10,000 test interval maintenance, see Section 7.5: Test
Interval Maintenance: 10,000 Tests in the Operator's Guide.
• For information about the Special Clean routine, see Section 7.2: Daily
Maintenance in the Operator's Guide.
• For information about System Check routines, see Section 4.4: System Check
Routines.
• For information about QC, see Section 6.3: Running Quality Control Tests in

C95318-AA
6.4: Fluidics Support Procedures UniCel DxI Reference Manual
6.4
Fluidics Support Procedures
Perform a fluidics support procedure only if you are instructed to do so by a technical
support representative or by the system documentation.
WARNING
You will come in contact with potentially infectious materials during these
Decontam- Use this procedure to decontaminate the substrate system and any components that
inating the come in direct contact with the substrate.
Substrate
System CAUTION
Perform this procedure only when instructed to do so by a technical support
representative.
WARNINGS
• You will use Citranox cleaning solution in this procedure. Citranox is acidic
and may cause eye or skin irritation. Handle according to proper laboratory
procedures. See the manufacturer's label for details.

C95318-AA
UniCel DxI Reference Manual 6.4: Fluidics Support Procedures
Symptoms of Substrate Contamination

The following symptoms may indicate that your substrate system is contaminated.
• High substrate check values (> 9,000 RLUs)
• Low substrate check values (<3,000 RLUs)
• Increased zero calibrator RLUs for sandwich assays
• Shift up in the analyte concentration responses for sandwich assays
• Shift down in the analyte concentration responses for competitive assays
• Increased variability in results, especially low signal calibrators
Substrate System Contaminants
Bacteria Dust
Metal ions Oil from fingertips
Talc from gloves Wash buffer
Alkaline phosphatase from a test Residual Citranox from an unsuccessful
reagent pack decontamination procedure
If you suspect that your UniCel DxI system is contaminated, contact Technical
Support to verify before you perform the decontamination procedure.
Required Materials
• Container or glassware for measuring 100 mL of cleaning solution
• Citranox cleaning solution
• Empty substrate bottles (2)
• Lint-free tissues
• Unopened bottles of substrate (2)
NOTE
Allow the substrate to equilibrate at room temperature for the amount of time
specified in the reagent instructions for use before loading the bottles on the
instrument. For more information, see the reagent instructions for use.

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Preparing Diluted Cleaning Solution

Use this procedure to prepare 100 mL of a 20% dilution of Citranox cleaning solution.
WARNING
Citranox cleaning solution is acidic and may cause eye or skin irritation. Handle
according to proper laboratory procedures. See the manufacturer's label for
details.
1. Measure 80 mL of deionized water into a container.
2. Add 20 mL of Citranox cleaning solution.
Priming with 20% Citranox

Use this procedure to prime the substrate system with 20% Citranox cleaning solution
during a substrate system decontamination.
WARNING
In this procedure you will handle Citranox cleaning solution. Citranox is acidic
and may cause eye or skin irritation. Handle according to proper laboratory
procedures. See the manufacturer's label for details.
System Mode: Ready

1. Fill two empty substrate bottles with 50 mL of 20% Citranox.
2. From the Maintenance Review screen, select Decontaminate Substrate F4.

A message informs you that any on-board substrate will be lost.
3. Select OK F1 to continue, which displays the Decontaminate Substrate window.

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2271B.bmp
Cycles (Table) Displays the priming cycle information for the left and right substrate
bottles. The system primes three different times during the decontamination
procedure.
• Citranox Cycles - The system begins the decontamination procedure by
priming with 20% Citranox.
• Air Cycles - The system follows the 20% Citranox prime by priming with air.
• Final Cycles - The system completes the procedure by priming with substrate.
Each row in the table displays the total and remaining number of primes for a given
cycle. The total number of priming cycles is the value displayed on the left, and the
remaining number of priming cycles is displayed on the right. A flashing set of
values indicates the current priming cycle and bottle being primed.
Dwelling Time (Field) Displays the length of time the cleaning solution remains in the substrate
(Seconds) system before the instrument draws a cycle of air through the substrate lines. The
acceptable range is from 0-3600 seconds.
Next (Button) Select to continue with the next step of the procedure.
F1
Figure 6-9 Decontaminate Substrate Window Descriptions

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4. Enter the number of seconds in the Dwelling Time field. The dwelling time is the
length of time the cleaning solution remains in the substrate system before the
instrument draws a cycle of air through the substrate lines. The acceptable range
is from 0-3600 seconds.
5. Select Next F1 to confirm the dwelling time and to display the next step in the
window.
6. Unload both of the on-board bottles of substrate. Discard the bottles in your
biohazard waste container. For more information, see Section 2.2: Substrate in
7. Load the substrate bottles that each contain 50 mL of 20% Citranox cleaning
solution.
8. Select Next F1 to continue.

The system primes the substrate system with the cleaning solution from the two
substrate bottles. Priming begins with the left bottle, and the system alternates
between the left and right bottles. You can monitor the progress in the Citranox
Cycles row. For example, the number 8/4 means there are 8 total priming cycles
and 4 remaining cycles. A flashing set of values indicates the current priming
cycle and bottle being primed.
After the 20% Citranox priming is complete, the cleaning solution remains in the
pump circuit for the amount of time specified in the Dwelling Time field.
NOTE
If you select Cancel F8 while the system is priming with 20% Citranox, an event
is logged in the Event Log and you cannot load substrate until the
decontamination procedure is completed successfully.
Air Priming Cycle

1. After the system finishes priming with 20% Citranox, both substrate doors open
and the system primes five cycles of air from both bottles.
NOTE
If you select Cancel F8 while the system is priming with air, an event is logged in
the Event Log and you cannot load substrate until the decontamination procedure
is completed successfully.
2. When the next step is displayed in the window, unload both bottles of cleaning
solution. For more information, see Section 2.2: Substrate in the Operator's
Guide.

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3. Pull down gently on the left substrate door handle to lower the substrate draw
tube. Pull down far enough to allow you to reach the draw tube easily.
4. While holding the substrate door handle in position, wipe down the draw tube
with a clean, lint-free tissue.
5. Gently raise the substrate door handle until the substrate door is completely open.
6. Repeat steps 3-5 to wipe down the right draw tube inside of the right substrate
door.
CAUTION
In the following step, be sure both load trays are pushed in and locked into place
before you select Next F1. If the load trays are extended when you select Next F1,
the substrate load doors will close down on both trays and may damage them.
7. Additional options are displayed in the window. Select the

New Substrate Bottles option and then select Next F1.
Both of the substrate loading doors close. Then the left substrate loading door
opens.
2275B.bmp
New Substrate (Option) Select this priming option to prime the substrate
Bottles system with two fresh bottles of substrate.
Empty Bottles (Button) This priming option is only used by
Beckman Coulter manufacturing personnel and your
technical support representative. Do not select this
option.
Figure 6-10 Decontaminate Substrate Window Descriptions -

Bottle Options
Final Priming Cycle

1. Open two new, equilibrated bottles of substrate.
2. Load a new bottle of substrate behind the left load door. For more information,
see Section 2.2: Substrate in the Operator's Guide.
The right substrate load door opens after you scan the bar code label on the left
bottle of substrate.

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3. Load a new bottle of substrate behind the right load door.
4. Select Next F1 to begin the final priming cycles.

When the system finishes the decontamination procedure, an event is logged in
the Event Log.
NOTE
If you select Cancel F8 while the system is priming with substrate, an event is
logged in the Event Log and you cannot process samples until the
decontamination procedure is completed successfully.
5. Select Done F1 to exit the Decontaminate Substrate window.
6. Run the System Check routines to confirm that the substrate is no longer
contaminated. For more information, see the Running System Check Routines
procedure in Section 4.4: System Check Routines.
7. Verify system performance. For more information, see Section 7.4: Test Interval
Maintenance: 5,000 Tests in the Operator's Guide.
Cleaning a Cleaning a sample probe is not part of the UniCel DxI routine maintenance
Sample Probe procedures. Clean the sample probe if any of the following conditions occurs.
• The sample probe is not aspirating as indicated by aspiration monitor errors,

QNS errors, or failed carryover tests.
• The sample probe comes into contact with a clot or gel from a primary tube,
and fails a subsequent carryover test.
• You are directed to clean the sample probe by Beckman CoulterTechnical
Support.
NOTE
Do not perform this procedure if the sample probe assembly on your instrument
does not match the assembly presented in Figure 6-11. Contact Technical Support
if your system is fitted with a different sample probe assembly.
Required Materials
To remove, clean, and install the sample probe:
• dry paper towel
• 70% ethanol or methanol solution

C95318-AA
• alcohol wipes
• lint-free tissues
• empty beakers or containers
• syringe and syringe fitting assembly from the aspirate probe clean kit
To perform the automated sample carryover procedure:

• nine 2 mL sample cups
• three sample racks for use with 2 mL sample cups
• Access System Check Solution
• UniCel DxI Wash Buffer
Remove the Sample Probe

Perform these steps to remove the sample probe.
WARNINGS
• Always be careful when placing your hands inside the instrument. Some
mechanical parts contain sharp edges that may puncture your skin. Do not
touch any component except as instructed to do so in this procedure.
CAUTION
You will open the instrument covers during this procedure. Opening the covers
abruptly shuts off power to the upper cabinet, and may cause damage if the
system is not in a proper mode and the user interface is not displaying the
correct screen that is described in this procedure.
1. Open the left main upper cover of the instrument. The system should immediately
go to the Not Ready mode.

C95318-AA
WARNING
If the system remains in the Ready mode after opening the left main upper cover,
then close the cover and contact Technical Support before proceeding.
CAUTION
Handle the sample probe with care to avoid damaging the probe tip.
3
4
5
2375A.eps
1 Track
2 Front z-guide
3 Probe tubing
4 Probe tubing fitting
5 Probe guide
6 Sample probe
7 Probe guard
Figure 6-11 Redesigned Sample Probe

C95318-AA
NOTE
2. Grasp the sample pipettor assembly and pull the assembly forward along the track
toward the front of the instrument. The assembly should move easily with the
motors disabled.
3. Place a dry paper towel underneath the probe guard to protect the top of the SPU
from any residual liquid that may drip from the probe tubing.
4. Remove the probe tubing from the front z-guide pathway.
5. Turn the probe tubing fitting counterclockwise to disconnect the probe tubing
from the probe guide.
6. Grasp the sample probe and push it up through the probe guide to remove the
sample probe from the instrument.
Clean the Sample Probe
WARNINGS
• Ethanol and methanol are extremely flammable. Do not use near heat or
flame. Do not ingest. Avoid contact with eyes, skin, and clothing. Use with
adequate ventilation.
CAUTION
1. Wipe the outside of the probe with an alcohol wipe or lint-free tissue soaked in
alcohol. Remove any visible residue.
2. Soak the entire sample probe in 70% ethanol or methanol in an empty beaker or
container for 5-10 minutes to help loosen any gel inside the probe.
3. Remove the sample probe from the 70% alcohol and wipe with a lint-free tissue.

C95318-AA
4. Attach the syringe fitting assembly to the syringe (see Figure 6-12).
0400e.eps
1 Syringe
2 Syringe fitting assembly
Figure 6-12 Attaching the Syringe Fitting Assembly
5. Push the sample probe tip into the open end of the tubing on the syringe fitting
assembly. Place the other end of the sample probe into a container of 70% ethanol
or methanol.
CAUTION
To avoid forcing any obstructions further into the probe. only draw the
solution through the probe into the syringe. Do not push the liquid from the
syringe back through the probe.
6. Draw the alcohol solution through the probe tubing fitting and into the syringe.
7. Remove the syringe from the syringe fitting assembly and push the alcohol
solution into a container for discard.
8. Reattach the syringe to the syringe fitting assembly and repeat steps 6-7 two more
times.
9. Remove the probe fitting from the alcohol solution.
10. Reattach the syringe to the syringe fitting assembly.
11. Draw air through the probe and into the syringe.
12. Remove the syringe from the fitting assembly, and then gently remove the
assembly from the probe tip.
13. Position the probe upright on absorbent paper for about 10 minutes to drain any
residual fluid. Wipe the outside of the probe with a lint-free tissue.

C95318-AA
14. Dispose of the 70% ethanol or methanol solution according to your laboratory
guidelines.
Install the Sample Probe
WARNINGS
• Always be careful when placing your hands inside the instrument. Some
mechanical parts contain sharp edges that may puncture your skin. Do not
touch any component except as instructed to do so in this procedure.
CAUTION
1. Insert the sample probe into the probe guide from the top and then lower the
sample probe into position.
2. Insert the probe tubing fitting into the probe guide.
3. Turn the probe tubing fitting clockwise until the fitting clicks into place.
NOTE
The probe guide is pre-aligned at installation. No alignment is required after
sample probe replacement.
4. Route the probe tubing through the front z-guide pathway.

5. Remove the paper towel.
6. Close the left main upper cover. For more information, see the Opening and
Closing the Main Upper Covers procedure in Section 6.2: Instrument Cover
Procedures.
7. Initialize the system. For more information, see the Initializing the System
procedure in Section 4.2: Initialize System. Wait until the system returns to the
Ready mode before proceeding.

C95318-AA
Prime the Sample Pipettor

Perform these steps to prime the sample pipettor on the DxI instrument after installing
a sample probe.
System Mode: Ready
1. From the DxI user interface, select Prime Fluidics F2 from the Diagnostics menu
to display the Prime Fluidics window
2. Check the Sample Pipettor box and enter 10 cycles in the Cycles Requested
field.
3. Select Start Priming F2 to prime the sample pipettor. When the priming is
complete, a confirmation message is displayed.
4. Select OK F1 to return to the Prime Fluidics window.
5. Select Done F1 to return to the Main Menu.
Confirm the Sample Probe Function

1. Run the automated carryover test to verify the sample probe is functioning
correctly. For more information, see the Running the Automated Carryover Test
procedure in Section 4.7: Carryover Testing.
2. Review and print the results of a completed carryover test on the DxI Carryover
screen. For more information, see the Reviewing and Printing Carryover Results
procedure in Section 4.7: Carryover Testing.
3. Run Quality Controls and ensure that laboratory specifications are met.
Recalibrate and repeat as necessary.
Replacing a Replacing a sample probe is not part of the UniCel DxI routine maintenance
Sample Probe procedures. Replace the sample probe if any of the following conditions occurs.
• The sample probe is damaged and is not aspirating.as indicated by aspiration
monitor errors, QNS errors, or failed carryover tests, AND the problem was
not resolved by cleaning the sample probe
• The sample probe comes into contact with a clot or gel from from a primary
tube, fails a subsequent carryover test, AND the problem was not resolved by
cleaning the sample probe
• You are directed to replace the sample probe by Beckman Coulter Technical
Support.

C95318-AA
NOTE
1. Remove the used sample probe. For instructions, see the Remove the Sample
Probe procedure in this section. Dispose of the used sample probe according to
local regulations.
2. Insert a new sample probe. For instructions, see the Install the Sample Probe
3. Prime the sample pipettor. For instructions, see the Prime the Sample Pipettor
4. Confirm the sample probe function. For instructions, see the Confirm the Sample
Probe Function procedure in this section.

C95318-AA
6.5: Rack and SPU Support Procedures UniCel DxI Reference Manual
6.5
Rack and SPU Support
Procedures
The sample presentation unit (SPU) can become obstructed by damaged sample racks
or by racks loaded improperly in the SPU. In addition, stray vessels or pieces of
sample bar code labels may impede movement of the sample presentation tray. Rack
labels may become too damaged for bar code scanning. And, if completed racks fill
up the offload areas of the SPU, new racks cannot be loaded. You can identify rack
and SPU errors from the kinds of events that display in the Event Log. Handle these
and other rack and SPU errors promptly to limit disruption to new sample processing.
Event troubleshooting procedures available from the Event Log refer you to support
procedures for resolving rack and SPU errors.
WARNING
You will come in contact with potentially infectious materials during these
Clearing a When a rack is loaded in the SPU facing the wrong direction, the bar code reader is
Backward not able to scan the rack to obtain the information necessary to continue processing.
Rack Use this procedure to remove and properly reload the rack for processing.
WARNING

C95318-AA
UniCel DxI Reference Manual 6.5: Rack and SPU Support Procedures
1. Open the SPU cover (see Figure 6-13). If the onload pusher motion indicator light
is on or blinking, press the Routine button and wait for the light to turn off. Then
open the SPU cover.
• If all of the racks are backward, the SPU cover will not open until all of the
racks have moved to the offload area of the SPU.
• If racks are no longer moving through the SPU and the SPU cover does not
open, continue troubleshooting with the Clearing a Damaged or Out of
Position Rack procedure.
3
1 4
2
LOAD LOAD
ROUTINE STAT
5
2182C.eps
1 SPU cover
2 Routine button
3 Load lights
4 STAT button
5 Onload pusher motion indicator
Figure 6-13 SPU Cover and Load Button Locations
2. With the SPU cover open, remove all racks that are facing the wrong direction
(see Figure 6-14 for the correct direction) from the front onload and front offload
areas of the SPU.

C95318-AA
4
6
3
2
5
1
51
0
2
4
3
1
2150B.eps
1 Guide rails
2 Rack correctly loaded, with bar code facing right
3 Rack ID label side of the rack, with the rack arm on the guide rail
4 Front onload area of the SPU
5 End of onload sensor
6 Presentation tray gate in the sample presentation area (gate is up)
Note: The tray gate shown is for the UniCel DxI 800 instrument.
7 Sample aliquot station (with the sample presentation tray inside)
Figure 6-14 Rack Correctly Loaded in the SPU
3. For the UniCel DxI 800 instrument only, open the side offload area cover and
remove all backward racks from the side offload area of the SPU.
4. Select the Rack Exceptions button from any screen and then review and remove
the exceptions. For more information, see the Clearing an Exception from the
Exceptions View procedure in Section 3.1: Sample Manager Overview of the
Operator's Guide.
5. Correctly load all backward racks removed from the system, making sure that the
rack bar code label faces the right (see Figure 6-14) as you face the instrument,
and the rack ID label is on the side of the rack closest to you. For more
information, see the Loading a Rack for Routine Processing procedure
in Section 3.4: Loading and Unloading Racks of the Operator's Guide.
6. Close the SPU covers and continue processing.

C95318-AA
Clearing a When a rack in the SPU is damaged or is pushed out of position by a sticky substance
Damaged or or stray object in the SPU, the rack may not move properly through the SPU. Use this
Out of Position procedure to remove and properly load the rack or its contents again for processing.
Rack
WARNING
1. Try to open the SPU cover. When the SPU cover opens, continue troubleshooting
with step 2 of this procedure.
If the SPU Then ... For more information ...

cover ...
Does not Press the Routine button and See the SPU cover and
open wait for the onload pusher indicator light in Figure 6-13
motion indicator light to turn off.
Still does Select Diagnostics F7 from the See the Diagnostic Menu in
not open Main Menu. If available, select Figure 4-1
Unlock SPU F8 and wait for the
onload pusher motion indicator
light to turn off.
Still does Initialize the system. See the Initializing the System
not open Note: The system initialization
procedure in Section 4.2:
function becomes available when Initialize System.
all samples in process are
completed, which may take up to
two hours.
Still does Shut down and restart the See the Shutting Down the
not open instrument. Instrument and the Restarting
the Instrument procedures in
Section 6.3: Shut Down and
Restart Procedures.
Still does Open the SPU lower panel and See the Opening and Closing
not open release the cover lock. the SPU Lower Panel and
Releasing the SPU Cover
Lock procedures in Section
6.2: Instrument Cover
Procedures.

C95318-AA
2. With the SPU cover open, remove any damaged or out of position racks from the
onload and offload areas of the SPU.
CAUTION
In the following step, do not try to force the sample presentation tray out of the
sample aliquot station. Pulling on the tray, or for the UniCel DxI 800 only,
pushing down on the gate, can bend the tray and may result in damage or
continued SPU errors.
3. Remove any racks in the sample presentation area (see Figure 6-14). However, do
not try to remove racks from inside the sample aliquot station.
NOTE
When the presentation tray gate is up (see Figure 6-14), the sample presentation
tray is in the sample aliquot station.
4. Close the SPU cover and press the Routine button (see Figure 6-13).
5. When the onload pusher motion indicator light turns off, open the SPU cover
again.
6. If any racks remain in the sample aliquot station (see Figure 6-14), continue with
the Removing a Rack Obstructing the Sample Aliquot Station procedure.
7. If there are racks in the sample presentation tray, remove them.
8. Inspect the sample presentation area. Clear any obstructions, including bits of
sample label or rack label material, or broken pieces from a rack, if found.
• If there was a grinding sound prior to the rack obstruction, a stray vessel may
be in the area. Look under the sample presentation tray. Remove the vessel if
you can. Contact Technical Support if you locate a vessel in the sample
presentation area that you cannot remove.
9. Inspect the onload and offload areas of the SPU. If repeated rack and SPU errors
are occurring or if the onload or offload areas contain spilled sample, clean the
SPU. For more information, see the Cleaning the SPU and Sensors procedure.
10. Inspect the sample racks that you removed from the instrument. Look for broken
rack arms (see Figure 6-14). Look for curled or ripped labels. Remove the
samples and lay the empty racks on a flat surface and look for warping.
• If a rack or its label is damaged, replace it. For more information on label
placement, see the Attaching Rack Labels procedure in Section 2.3: Supplies
Setup.

C95318-AA
• If you replace any racks that have manually requested tests that have not been
successfully scanned, edit the Rack ID of the test requests. For more
information, see the Editing a Manual Test Request procedure in Section 3.6:
Editing Test Requests of the Operator's Guide.
11. Return unprocessed samples to racks that pass the inspection.
12. Load the racks on the system. For more information, see the Loading a Rack for
Routine Processing procedure in Section 3.4: Loading and Unloading Racks of
• If the Event Log button is red or yellow, select the button and review the
events before you continue processing.
Removing a Use this procedure to manually remove a rack obstructing the sample aliquot station.
Rack The SPU lower panel may be closed or open.
Obstructing
the Sample NOTE
Aliquot Before beginning this procedure, try to remove the rack by following the Clearing
Station a Damaged or Out of Position Rack procedure. That procedure refers you to this
procedure if the system has not ejected the rack.
WARNING
1. If the SPU lower panel is open, continue with step 6.
2. Initialize the system. For more information, see the Initializing the System
procedure in Section 4.2: Initialize System.
NOTE
The system initialization function becomes available when all samples in process
are completed, which may take up to two hours.
3. If the system ejected the sample presentation tray from the aliquot station during
initialization, continue with step 9.

C95318-AA
4. If the rack is still obstructing the sample aliquot station, shut down and restart the
instrument. For more information, see the Shutting Down the Instrument and the
Restarting the Instrument procedures in Section 6.3: Shut Down and Restart
Procedures.
• If the system ejects the sample presentation tray from the aliquot station
during shut down or restart, continue with step 6.
5. If the rack is still obstructing the sample aliquot station, open the left main upper
cover and the SPU lower panel. For more information, see the Opening and
Closing the SPU Lower Panel procedure.
6. Step behind the open SPU lower panel and move toward the hinge connecting the
panel to the instrument. Open the panel wider, as needed (see Figure 6-15).
1
3
2325A.eps
1 Instrument, viewed from the top, with the SPU lower panel open
2 Back side of the SPU from behind the open SPU lower panel view, at the hinge end
3 Presentation tray drive belt, with isolated view of the direction to turn the top of the belt
Figure 6-15 Presentation Tray Drive Belt, Back Side of the SPU Lower Panel

C95318-AA
CAUTION
In the following step, if the presentation tray drive belt does not move smoothly
with minor resistance, stop moving the belt and look for an obstruction under
the sample presentation tray. Clear the obstruction. Contact Technical Support
if you need assistance.
7. Locate the presentation tray drive belt (see Figure 6-15) and move the top of the
belt toward you. Repeat this movement until the sample presentation tray is
completely out of the sample aliquot station and the belt stops moving.
NOTE
You can watch the sample presentation tray move by leaning over the SPU and
looking under the SPU cover.
CAUTION
Contact Technical Support if you cannot remove the racks in the following step.
8. Return to the front of the instrument and remove the racks in the sample
presentation tray.
9. Inspect the sample presentation area. Clear any obstructions, including bits of
sample or rack label material, or broken pieces from a rack, if found.
• If there was a grinding sound prior to the rack obstruction, a stray vessel may
be in the area. Look under the sample presentation tray. Remove the vessel if
you can. Contact Technical Support if you locate a vessel in the sample
presentation area that you cannot remove.
10. Inspect the onload and offload areas of the SPU. If repeated rack and SPU errors
are occurring or the onload or offload areas contain spilled sample, clean the
SPU. For more information, see the Cleaning the SPU and Sensors procedure.
11. Close the SPU lower panel and the left main upper cover. For more information,
see the Opening and Closing the SPU Lower Panel procedure.
NOTES
• Although you are closing the SPU lower panel, you can delay initializing the
system until a later step in this procedure.
• The temperatures may be out of range from having the covers open. Samples
will not run until temperatures are within operating range. After opening the
SPU lower panel, it commonly takes about ten minutes to restore
temperatures.

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13. With the system in the Ready or Not Ready mode, initialize the system. For
more information, see the Initializing the System procedure in Section 4.2:
Initialize System.
• If the system fails to initialize and return to the Ready mode, contact
Technical Support.
• If the system enters the Paused mode, select the Resume button.
14. If the Event Log button is red or yellow, select the button and review the events
before you continue processing.
15. Inspect the sample racks that you removed from the instrument. Look for broken
rack arms (see Figure 6-14). Look for curled or ripped labels. Remove the
samples and lay the empty racks on a flat surface and look for warping.
• If a rack or its label is damaged, replace it. For more information on label
placement, see the Attaching Rack Labels procedure in Section 2.3: Supplies
Setup.
• If you replace any racks that have manually requested tests that have not been
successfully scanned, edit the Rack ID of the test requests. For more
information, see the Editing a Manual Test Request procedure in Section 3.6:
Editing Test Requests of the Operator's Guide.
16. Return unprocessed samples to racks that pass the inspection.
17. Open the SPU cover and load the racks on the system. For more information, see
the Loading a Rack for Routine Processing procedure in Section 3.4: Loading and
Unloading Racks of the Operator's Guide.

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Cleaning the Sample may spill from improperly loaded racks or racks that get jammed in the SPU.
SPU and When sample dries, it can become sticky and prevent proper rack movement or sensor
Sensors operation. Use this procedure to clean the onload and offload areas of the SPU, the
end of onload sensor, and the offload rack sensor.
NOTE
If repeated rack and SPU errors are occurring and cleaning the SPU and sensors
does not resolve the problem, contact Technical Support.
WARNING
Required Materials
• Proper hand, eye, and facial protection
• Deionized (DI) water
• Lint-free tissues
• Lint-free swab
• Tweezers, as needed
1. This procedure begins with the SPU cover open. For information on opening the
SPU cover, see the Loading a Rack for Routine Processing procedure in Section
3.4: Loading and Unloading Racks of the Operator's Guide.
2. Depending on the troubleshooting procedure that you are following, or the visible
condition of the SPU, determine which of the following areas of the SPU that you
will clean (see Figure 6-16).
• The onload area and end of onload sensor
• The front offload area
• On a UniCel DxI 800 instrument only, the offload rack sensor
• On a UniCel DxI 800 instrument only, the side offload area

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1
3
2
2305C.eps
1 Front onload and offload areas of the SPU

2 Location of the end of onload sensor, to the right of the sample
presentation area inside the SPU
3 On a UniCel DxI 800 instrument only, the location of the offload rack
sensor, on the bottom of the SPU
4 On a UniCel DxI 800 instrument only, the side offload area of the SPU
Figure 6-16 Location of Rack Sensors in the SPU, Top View
Cleaning the Onload Area and Sensor

1. Remove all racks from the onload area of the SPU.
2. Moisten a lint-free, clean tissue with DI water, and then wipe down the interior of
the onload area of the SPU with the tissue. Use additional moist tissues, as
needed.
• Wipe the bottom and sides of the SPU.
• Wipe the guide rails (see Figure 6-14), but avoid the end of onload sensor,
which will be cleaned with a swab.
3. Moisten a lint-free swab with DI water, and then carefully wipe all sides of the
end of onload sensor clean with the swab.
4. Return the racks to the onload area of the SPU and close the SPU cover.
Cleaning the Front Offload Area

1. Remove all racks from the front offload area of the SPU. For more information,
see the Unloading a Rack procedure in Section 3.4: Loading and Unloading
Racks of the Operator's Guide.

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CAUTION
On the UniCel DxI 800 instrument, be careful cleaning around the offload rack
sensor (see Figure 6-16), which can break if forced.
2. Moisten a lint-free, clean tissue with DI water, and then wipe the interior (guide
rails, sides, and bottom) of the front offload area of the SPU with the tissue. Use
additional moist tissues, as needed.
Cleaning the Front Offload Sensor

(UniCel DxI 800 Instrument Only)
CAUTION
Be careful cleaning the offload rack sensor, which can break if forced.
1. Locate the offload rack sensor at the bottom of the left end of the SPU (see Figure
6-16). When the front offload area of the SPU fills, the rack on the left end
activates this sensor by pushing it below the bottom surface of the SPU. With the
racks removed, the sensor should be visible above the bottom surface of the SPU.
• If the offload rack sensor is stuck below the bottom surface of the SPU, use
your gloved finger to lightly tap and release it, or a tweezers to gently lift it
up.
2. Moisten a lint-free swab with DI water and carefully wipe all sides of the sensor
clean.
Cleaning the Side Offload Area of the SPU

(UniCel DxI 800 Instrument Only)
1. Open the cover of the side offload area (see Figure 6-16).
2. Moisten a lint-free, clean tissue with DI water, and then wipe the interior (sides
and bottom) of the side offload area of the SPU with the tissue. Use additional
moist tissues, as needed.
3. Close the side offload area cover.

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6.6: Reagent Pack Movement Support Procedures UniCel DxI Reference Manual
6.6
Reagent Pack Movement
Support Procedures
The reagent pack gripper moves each reagent pack from the reagent load area to one
of 50 slots in the reagent storage area of the DxI instrument. As reagent is needed for
requested tests, the gripper moves the pack from its inventoried slot to a reagent
pipetting station. The pack is then returned to an open slot or, when empty, moved for
disposal as solid waste. A reagent pack gripper failure can disrupt movement of the
packs and may cause packs to drop or be damaged.
You can identify reagent pack and gripper errors from the kinds of events in the Event
Log. Handle these and other DxI instrument errors promptly to limit disruption to
onboard sample processing. Event Log troubleshooting procedures refer you to
support procedures for resolving reagent pack movement errors. You may need to
contact Technical Support to resolve underlying mechanical, electrical, or alignment
problems.
Removing a
CAUTION
Reagent Pack
Obstruction Perform this procedure only as directed by Technical Support or by system
from Inside documentation.
the Instrument Reagent delivery can be interrupted when a reagent pack obstructs movement in the
reagent storage area or when a reagent pack slot or the reagent gripper is dirty,
damaged, or out of position. You may suspect a reagent pack obstruction when the
Event Log reports that the reagent pack gripper fails to home or to initialize. Use this
procedure to remove the reagent storage cover and inspect for and resolve reagent
pack errors inside the instrument.

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UniCel DxI Reference Manual 6.6: Reagent Pack Movement Support Procedures
WARNINGS
Required Supplies
• Proper hand, eye, and facial protection
• 3/16-inch hex wrench to open the SPU lower panel
• 5/32-inch hex wrench to open the reagent storage cover
NOTE
If you do not have the required hex wrenches, you can order them individually as
3/16- and 5/32-inch ball screwdrivers through Beckman Coulter.
1. Select Device Diagnostics F4 from the Diagnostics Menu, and then open the left
main upper cover. For more information, see the Opening and Closing the Main
Upper Covers topic in Section 6.2: Instrument Cover Procedures.
2. Open the SPU lower panel. For more information, see the Opening and Closing
the SPU Lower Panel topic in Section 6.2: Instrument Cover Procedures.
3. Step inside the SPU lower panel opening and face the reagent storage cover (see
Figure 6-17).

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2336A.eps
Figure 6-17 Reagent Storage Cover and Location of Screws
4. Using a hex wrench, remove the six 5/32" screws securing the reagent storage
cover (see Figure 6-17) and set the screws in a secure place. Then, pull the cover
away from the instrument and set the cover aside.
WARNING
In the following step, if a reagent pack has tipped over, discard the pack.
Reagent may have spilled out of the pack or may have cross-contaminated
reagents within individual wells of the pack. Missing or contaminated reagent
may adversely affect patient results.
5. Look for and remove dropped reagent packs at the bottom of the reagent storage
area (see Figure 6-18, item 4). If a reagent pack has tipped over, discard the pack.

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1 3
4
5
2337A.eps]
1 Reagent pack gripper slide arm

2 Reagent pack gripper jaw (see Figure 6-19 for a closer view)
3 Reagent pack out of position in its slot
4 Dropped reagent pack
5 Reagent pack gripper body
Figure 6-18 Reagent Storage Area with Out of Position Reagent Packs
CAUTIONS
• If a reagent pack is out of position, always try to remove it. Do not try to
force it into position in the slot at the risk of damaging the pack or the
brackets for the slot.
• If you cannot remove an out of position reagent pack with minimal effort in
the following steps, contact Technical Support.
6. Look for and remove reagent packs that are clearly out of position (see Figure
6-18, item 3).

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7. Visually scan all remaining reagent packs to verify their proper position in the
slots. Remove any pack suspected to be out of position.
8. Examine the reagent gripper (see Figure 6-19).

• If either side of the gripping mechanism (gripper jaw) is out of position, or if
you see damage, contact Technical Support.
2338A.eps
Figure 6-19 Reagent Pack Gripper
9. Manually move the reagent pack gripper to home position, at the lower left of the
storage area (see Figure 6-20).
Gripper movement
• The reagent pack gripper can be moved only horizontally and vertically
between pairs of two reagent slots. Take hold of the reagent gripper body to
slide the gripper up or down along a vertical path. Take hold of the gripper
slide arm to slide the gripper to the left or right along a horizontal path.
• The gripper moves best along the main pathways (see Figure 6-20).
• If you cannot move the gripper smoothly to or along a pathway, the gripper
jaw may be open. Squeeze the gripper jaw together to close it before
attempting the move again. If you continue to have trouble moving the
gripper, contact Technical Support.

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2340A.eps
Figure 6-20 Pathways to the Reagent Pack Gripper Home Position
10. With the reagent gripper in home position and all out-of-position packs removed,
align the reagent storage cover above the screw holes and fasten the top screw in
the middle of the cover. You may need to lift the cover to align the screw with the
hole.
11. Fasten the remaining five 5/32-inch hex screws.
12. Close the SPU lower panel and lower right door. For more information, see the
Opening and Closing the SPU Lower Panel topic in Section 6.2: Instrument
Cover Procedures.
13. Close the left main upper cover of the instrument. For more information, see the
Opening and Closing the Main Upper Covers topic in Section 6.2: Instrument
Cover Procedures.
14. Initialize the system with the Remap option selected. For more information, see
the Initializing the System topic in Section 4.2: Initialize System.
NOTES
• Whenever the reagent storage cover has been removed, the Remap option for
initialization must be selected.
• Remapping the reagent inventory may take up to 20 minutes, depending on
how many reagent packs are on board the instrument.

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15. Inspect the removed reagent packs.
• If a pack shows evidence of damage or leaking, discard the pack.
16. Load the reagent packs showing no evidence of damage or leaking back on the
instrument. For more information, see the Loading a Reagent Pack topic in
Section 2.7: Reagent Supplies of the Operator's Guide.
Manually The reagent load door is locked when the instrument moves reagent packs to or from
Unlocking the reagent storage. The door is automatically unlocked when the instrument is done
Reagent Load moving the reagent packs. If the door does not unlock automatically, you can unlock
Door the door manually.
1. Locate the lower right door of the DxI instrument (see Figure 1-1 of the
Operator's Guide).
2. Open the lower right door by placing your finger in the indentation between the
the left side of the door and the right side of the wash buffer supply drawer.
Swing the door to the right, out and away from the instrument.
3. The release lever is located under the reagent load tray, in the cavity to the left of
the upper door hinge (see Figure 6-21).

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2335A.eps
Figure 6-21 Reagent Load Tray Release Lever inside the Lower Right Door
4. Move the release lever to the left, in the direction of the Unlock arrow.
5. Open the reagent load door.

• If the reagent load door still does not open, contact Technical Support.
6. Close the lower right door and continue routine or troubleshooting procedures.

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UniCel DxI Reference Manual :
A System Specifications
A.1 Space and Environmental Requirements ................................................ A-2
Space Requirements ......................................................................................... A-2
Instrument and Peripheral Device Weights ..................................................... A-3
Operating Environment Requirements............................................................. A-4
Electrical Requirements ................................................................................... A-4
A.2 Performance Characteristics ..................................................................... A-8
Instrument Operating Characteristics............................................................... A-8
Instrument Temperatures ................................................................................. A-9
Luminometer Performance .............................................................................. A-9
Reaction Vessel Properties............................................................................... A-9
Database Capacities ....................................................................................... A-10
Supply and Sample Capacities ....................................................................... A-11
Bar Code Hardware Performance Properties ................................................. A-12
Sample Bar Code Label Specifications.......................................................... A-15
© 2022 Beckman Coulter, Inc. A-1

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A.1: Space and Environmental Requirements UniCel DxI Reference Manual
A.1 Space and Environmental

Requirements
To operate properly, the UniCel DxI system requires specific spatial, environmental,
and electrical conditions.
Space The dimensions of the instrument and the peripheral devices are listed in the
Requirements following table. Be sure that the area designated for these components is large enough
to accommodate the system.
Instrument: Covers and Width = 67.5 inches (171 cm)

drawers closed
Height = 67 inches (170 cm)
Depth = 37.5 inches (97 cm)
drawers opened
Height = 75.2 inches (191 cm)
Instrument clearance Rear = 11.8 inches (30 cm)
required for ventilation
Top = 8.5 inches (22 cm)
Instrument clearance Front = 15.5 inches (39 cm)
required for opening covers
and drawers
Rear = 14.5 inches (37 cm)
Service clearance required Front = 38.5 inches (98 cm)
for opening SPU
System console (cart with Width = 29.8 inches (76 cm)

external computer and
peripherals)
Table A-1 UniCel DxI 800 Instrument Component Dimensions
A-2 © 2022 Beckman Coulter, Inc.

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UniCel DxI Reference Manual A.1: Space and Environmental Requirements

drawers closed
Height = 67 inches (170 cm)
drawers opened
Instrument clearance Rear = 11.8 inches (30 cm)
required for ventilation
Instrument clearance Front = 15.5 inches (39 cm)
required for opening covers
and drawers
Rear = 14.5 inches (37 cm)
Service clearance required Front = 36.5 inches (93 cm)
for opening SPU
System console (cart with Width = 29.8 inches (76 cm)

external computer and
peripherals)
Table A-2 UniCel DxI 600 Instrument Component Dimensions
Instrument The weight of the instrument and the peripheral devices are listed in the following
and table. Be sure that the area designated for these components can support the system.
Peripheral
Device UniCel DxI 800 Instrument 1,390 pounds (630 kg)
Weights (before supplies and
samples are added)
UniCel DxI 600 Instrument 1,065 pounds (483.1 kg)

(before supplies and
samples are added)
External computer See documentation provided by the

manufacturer
Monitor See documentation provided by the
manufacturer
Printer See documentation provided by the
manufacturer
Table A-3 Instrument Component Weights

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Operating The UniCel DxI system is for indoor use only and requires the following
Environment environmental conditions to operate properly:
Requirements
Humidity, RH Operational: 20-85%
(non-condensing)
Exposure: 10-85%
Maximum altitude Operational: 7,500 feet (2,300 m)
Exposure: 40,000 feet (12,200 m)
Temperature Operational*,†: 64°F to 86°F (18°C to 30°C)
Exposure: -22°F to 122°F (-30°C to 50°C)
Maximum ambient 3.6°F (2°C) per 30 minutes
temperature change rate
during operation
Ambient light Results not affected by ambient light levels

between 0-200 foot-candles
Pollution degrees 2
Table A-4 Operating Environment Requirements

* Some assays require additional temperature restrictions. See Appendix A of the UniCel DxI
Instructions for Use manual for information on these restrictions.
† The operating environment temperature is influenced by factors such as room temperature, air
circulation, heat sources near the system, and direct sunlight.
Electrical The UniCel DxI system uses two separate power supplies: one for the instrument, and
Requirements one for the external computer. Each power supply must meet specific requirements.
Electrical Line: Instrument

The electrical line supplies power to the UniCel DxI instrument. To avoid damaging
the instrument, the electrical line at the outlet should meet the following requirements:
Line power supply 200-240 VAC at 1,100 VA, at 50/60 hertz (Hz),
single phase power
Line dedication Dedicated (only the UniCel DxI instrument is
connected to the electrical line)
Line outlet Located within 5 feet (1.5 m) of the UniCel DxI
system. Must be compatible with the L6-20P
twist lock plug on the instrument.
Table A-5 Electrical Line Requirements: Instrument

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Line protection device AC outlet: Must be protected by a circuit

breaker rated at 20 amps (250 VAC line)
Instrument line fuse: T 10A, 240V
Line voltage fluctuations Not to exceed ±10 VAC per cycle

Minimum tested operating 180 VAC
voltage
Maximum tested operating 264 VAC

voltage
Maximum voltage between Not to exceed 2 VAC root mean square (RMS)
neutral conductor and
safety ground conductor
Maximum resistance Not to exceed 0.1 ohm

between the safety ground
conductor and an
accessible building safety
ground
Transient overvoltages According to UL3101 Installation Category II
Table A-5 Electrical Line Requirements: Instrument (continued)
Electrical Line: External Computer

The electrical line for the external computer must meet one of the following
requirements, depending on the available AC voltage range:
• 110-120 VAC at 6 amps, 50/60 Hz

• 220-240 VAC at 3 amps, 50/60 Hz
Electrical Power Consumption and Heat Production

The UniCel DxI components consume current and power, and produce heat at the
following levels:
Component Power Consumption Heat Production
Instrument < 1,100 watts 3,775 BTU/hour

External See documentation provided See documentation provided
computer by the manufacturer by the manufacturer
Table A-6 Power Consumption and Heat Production

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Component Power Consumption Heat Production
LCD monitor See documentation provided See documentation provided

by the manufacturer by the manufacturer
Laser printer See documentation provided See documentation provided
by the manufacturer by the manufacturer
Table A-6 Power Consumption and Heat Production (continued)
Surge Suppressors
Beckman Coulter recommends that you do not use a surge suppressor with the
UniCel DxI instrument. The instrument has built-in protection similar to that provided
by a surge suppressor.
PC Backup Power Supply (UPS Unit)

The UniCel DxI system is shipped with a backup power supply (UPS) for the PC
only. This UPS unit is designed to provide continuous AC power to the PC when the
main AC line power is lost.
NOTE
Consult the documentation provided by the UPS unit manufacturer for proper and
safe operation, including ventilation clearance requirements, of UPS units.
Instrument Backup Power Supply (UPS Unit)

If you intend to use an uninterruptable power supply (UPS unit) as a backup power
supply, Beckman Coulter recommends a UPS unit with local ground isolation and a
low-battery indicator. UPS units are designed to provide continuous AC power to
equipment when the main AC line power is lost. These units use a standby battery
with an AC inverter circuit to provide the required electrical output. Some units also
provide various combinations of the protection features found in surge suppressors
and line conditioning transformers.
NOTES
• Contact Beckman Coulter Technical Support for a recommended backup
power supply.
• Consult the documentation provided by the UPS unit manufacturer for proper
and safe operation, including ventilation clearance requirements, of UPS
units.

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Your UPS unit should meet the following requirements:
Minimum output capacity 2,400 VA

Output voltage 240 VAC, 120 VAC
Output frequency 50 or 60 Hz, single phase
Output wave form True sine wave (< 5% distortion)
Standby runtime Minimum 15 minutes at 1,500 watts output
Approvals UL 1778, CSA C22.2 107.1 (UL 544, optional),
CE Mark (Europe only)
Table A-7 Instrument Backup Power Supply Requirements

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A.2: Performance Characteristics UniCel DxI Reference Manual
A.2 Performance
Characteristics
The UniCel DxI instrument performance characteristics include instrument operating
characteristics and temperatures, luminometer performance, RV characteristics,
instrument capacities, and bar code hardware characteristics.
Instrument The UniCel DxI system has the following operating characteristics:
Operating
Character- Warm up Three hour maximum at operational temperature for
istics assay processing, internal sample storage area, and
reagent pack storage area.
Upper cabinet The system will not report results when the upper cabinet
temperature temperature is outside the acceptable limits of
64°F to 97°F (18°C to 36°C). The upper cabinet
temperature is influenced by factors such as room
temperature, air circulation, heat sources near the system,
and direct sunlight.
Processing speed The system throughput rate depends on individual assay
protocols and the mix of assays in any run.
Maximum throughput rate (UniCel DxI 800 instrument):
• 400 test results per hour for one-step assays
• 200 test results per hour for two-step assays
Maximum throughput rate (UniCel DxI 600 instrument):
• 200 test results per hour for one-step assays
• 100 test results per hour for two-step assays
Random access The instrument can run up to 50 different tests on any
sample, depending on available sample volume.
Table A-8 Instrument Operating Characteristics

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UniCel DxI Reference Manual A.2: Performance Characteristics
STAT access You can add STAT samples at any time during routine
operation. The instrument automatically adjusts the
priority of test requests for on-board samples and runs
the STAT sample first.
Continuous access You can enter new test requests while other samples are
in process. You can load system supplies while the
system continues to process tests.
Table A-8 Instrument Operating Characteristics (continued)
Instrument The UniCel DxI instrument keeps temperature-sensitive devices and reagents within
Temperatures the following temperature ranges:
Sample wheel 4.00ºC to 10.00ºC

Reagent storage 4.00ºC to 10.00ºC
Wash carousel 36.80ºC to 37.20ºC
Substrate (in the incubator) 36.90°C to 37.90°C
Table A-9 Instrument Temperatures
Luminometer The luminometer performs within the following read precision and drift limits:
Performance
Read precision within a ≤ 0.2% CV
single RV
Drift ≤ 0.5% in 4 weeks
Table A-10 Luminometer Performance
Reaction The UniCel DxI system RVs have the following properties:
Vessel
Properties Size Diameter = 0.315 inches (8 mm)
Height = 1.5 inches (38 mm)
Composition Polypropylene
Maximum capacity 1 mL
Table A-11 Reaction Vessel Properties

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Database The UniCel DxI system database stores a variety of processing information. The
Capacities system database capacity for each item stored is listed in the following table.
.
Database Item System Capacity
Calibrations 1,400 (6 per reagent lot)

Calibrator lots 300
Control lots 200
Control ranges 1,000
Event log entries 30 days of events (10,000 maximum)
Panels 100
Patient sample IDs 50,000
QC sample IDs 40,000
QC data points 40,000
Racks 400
Reagent packs 3,000 bar codes
Reference ranges 2,500
Sample IDs 100,000
Substrate lots 400
Tests 200,000
Table A-12 Database Capacities

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Supply and The UniCel DxI instrument can hold a sufficient quantity of supplies, reagents, RVs,
Sample liquid waste, solid waste, and samples to run for at least three hours without operator
Capacities intervention.
The following table lists the supply and sample capacities of the system.
Item Capacity Location
Racks - before UniCel DxI 800 instrument: 30 SPU onload area

aliquoting
UniCel DxI 600 instrument: 15
Racks - after aliquoting UniCel DxI 800 instrument: 31 SPU offload area
UniCel DxI 600 instrument: 15
On-board sample 288 Sample wheel
aliquots
Liquid waste (for UniCel DxI 800 instrument: 2 x 9.5 L Liquid waste drawer
systems using
on-board bulk liquid
UniCel DxI 600 instrument: 2 x 5.0 L
waste containers)
Solid waste UniCel DxI 800 instrument: 20 pounds (9.1 kg) Solid waste container
UniCel DxI 600 instrument: 10 pounds (4.6 kg)
RVs 1700-1800 Vessel hopper
Reagent packs 50 Reagent storage chamber
Substrate 2 x 130 mL (1,200 tests) Substrate load area
Wash buffer 2 x 10 L Wash buffer supply drawer
2 L reserve Wash buffer reservoir
Table A-13 Supply and Sample Capacities

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Bar Code The UniCel DxI system is equipped with four bar code readers:
Hardware
• The PC bar code reader (handheld)
Performance
Properties • The substrate bar code reader (handheld)
• The SPU bar code reader (internal), used to identify sample tubes and racks
• The reagent bar code reader (internal), used to identify reagent packs
PC Bar Code Reader

The PC bar code reader is a handheld unit on the system console, used to identify
calibrators and Access Immunoassay Systems controls. The PC bar code reader has
the following performance properties:
Bar code symbologies • CODABAR

• CODE 39
• CODE 93
• CODE 128
Read distance 1-8 inches (25-203 mm) on medium density
codes
Resolution 0.005 inches (0.13 mm) at a distance of
3.5 inches (89 mm)
Power requirements +5 ± 0.5 VDC
Table A-14 PC Bar Code Reader Performance Properties
Substrate Bar Code Reader

The substrate bar code reader is a handheld unit used to identify substrate bottles. The
substrate bar code reader has the following performance properties:
Bar code symbology CODE 93

Read distance 1-8 inches (25-203 mm) on medium density
codes
Resolution 0.005 inches (0.13 mm) at a distance of
3.5 inches (89 mm)
Power requirements +5 ± 0.5 VDC
Table A-15 Substrate Bar Code Reader Performance Properties

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SPU and Reagent Bar Code Readers

The SPU and reagent bar code readers are internal units used to identify sample racks
and containers, and reagent packs. The SPU and reagent bar code readers have the
following performance properties:
Bar code symbologies • CODABAR

• CODE 39
• CODE 93
• CODE 128
Minimum readable module 0.0075 inches (0.19 mm)
dimensions
Reflectance Light Bar: 50% minimum

Dark Bar: 10% maximum
Minimum reflectivity 37.5%
difference (MRD)
Table A-16 Internal Bar Code Reader Properties
SPU Bar Code Reader Default Settings

The bar code reader in the SPU is installed with the default settings shown in the
following tables. Settings that you can configure for your laboratory are noted.
CODABAR Parameter Setting Can Configure?
Send start/stop Disabled Yes

Check digit on Off Yes
Send check digit Disabled Yes
Large intercharacter gap Disabled No
Fixed code length Disabled No
Concatenation On No
Message length 1-24 characters* No
Table A-17 CODABAR Default Settings

* Includes start/stop digit and check digit, if set to send. Allowable characters are: A-Z, a-z, 0-9, +,
-, /, *.

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CODE 39 Parameter Setting Can Configure?
Send start/stop Disabled Yes

Large intercharacter gap Disabled No
Table A-18 CODE 39 Default Settings

* Includes start/stop digit and check digit, if set to send. Allowable characters are: A-Z, a-z, 0-9, +,
-, /, *.

* Includes start/stop digit and check digit. Allowable characters are: A-Z, a-z, 0-9, +, -, /, *.


* Includes start/stop digit and check digit. Allowable characters are: A-Z, a-z, 0-9, +, -, /, *.
Interleaved 2 of 5 Parameter Setting Can Configure?

Message length 4-15 characters* Yes
Table A-21 Interleaved 2 of 5 Default Settings

* Includes start/stop digit or check digit, if set to send. Allowable characters are: A-Z, a-z, 0-9, +, -,
/, *.

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Sample Bar A bar code label consists of vertical black bars (the bar code), the equivalent
Code Label characters printed underneath the bar code, and quiet zones at either end of the bar
Specifications code.
2
ABC123456789 3
2201A.eps
1 Quiet zones
2 Bar code
3 Equivalent characters
Figure A-22 Bar Code Label
When you scan a bar code label, the characters entered into a field are identical to the
characters printed below the bar code. However, if you configure the system not to
send the bar code check digits or start and stop characters, the system does not enter
those characters into the field. For information about how to configure the SPU bar
code reader and enable or disable the bar code reader parameters, see Section 2.4:
SPU Bar Code Reader Setup.
Beckman Coulter does not provide sample container bar code labels. Sample
container bar code labels must meet the following specifications.
Quiet zones 10 × (ten times) the element width of

the bar code, with a minimum of
0.2 inches (5 mm) at either end of the
label.
Message length 1-24 characters
Symbol length 3.0 inches (80 mm) maximum,
including quiet zones at either end
Symbol height 0.39 inches (10 mm) minimum
Symbology Must meet the specifications for the
SPU bar code reader as installed and
configured for your laboratory.
Table A-23 Sample Tube Bar Code Label Specifications

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Label print quality Quality B or better, as specified in

CLSI standard AUTO2-A, Laboratory
Automation: Bar Codes for Specimen
Container Identification
Label angular skew ≤ ±7.5 degrees tilt
Bar code label background Printed on reflective, matte finish with
a background diffuse reflectance of
70-80%
Bar code label ink color and type 10% for internal bar code reader
(maximum allowed reflectance at
the reading wavelength) 25% for handheld bar code reader
Table A-23 Sample Tube Bar Code Label Specifications (continued)

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UniCel DxI Reference Manual Glossary
Glossary
%CV
See coefficient of variation (CV).
A
A-D converter
A device that converts the analog signals from the instrument into a binary coded
form for the computer.
acceptance limits
See acceptance criteria.
acceptance criteria
The specifications within the assay protocol file that cause a calibration result to
pass or to fail.
For qualitative assays, the APF defines acceptance limits for the RLUs obtained
for means and replicates of each calibrator. If the RLUs obtained are outside these
limits, the assay calibration fails.
For some quantitative assays, the APF defines acceptance limits for the %CV of
the RLUs obtained for replicates of the S0 (zero) calibrator. If the %CV obtained
is outside these limits, the assay calibration fails.
For quantitative assays, the precision profile method is used to evaluate whether a
calibration curve meets the acceptance criteria.
active calibration
The assay calibration currently being used for reporting assay results.
alkaline phosphatase
An enzyme that acts on a wide variety of organic compounds by removing a
phosphate group. The enzyme label used in Access Immunoassay System assays
to produce chemiluminescence when substrate is added.
analyte
The specific substance in the sample (blood, urine, or other body fluid) that is
being measured or otherwise evaluated.
© 2022 Beckman Coulter, Inc. Glossary-1

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Glossary UniCel DxI Reference Manual
analytical module
The part of the instrument that receives and processes RVs containing sample.
Processing includes sample incubation, washing, reading, and positioning for
removal from the instrument.
antibody
A protein in body fluid that is formed in response to, and is capable of binding
with, an antigen. See also capture antibody.
antibody detection immunoassay
An assay that detects the presence of an antibody in a patient sample. In an
Access Immunoassay System antibody detection assay, the antibody binds to
paramagnetic particles, and is detected by an enzyme-labeled antibody that binds
to the antibody captured on the particle. For this assay result, the measured RLUs
are roughly proportional to the amount of antibody in the sample.
antigen
A protein or other molecule that initiates the production of antibodies by an
organism.
APF
See assay protocol file (APF).
aspirate probe
A tube that draws up fluids and unbound components from RVs after the bound
complexes have been pulled out of suspension by magnets. Aspirate probes are
removed and cleaned at recommended intervals during routine maintenance.
assay
See immunoassay.
assay protocol file (APF)
A software file that provides processing instructions specific for each assay. The
APF may be included on the system software CD or supplied on its own CD. An
updated APF may be supplied by Beckman Coulter, Inc. to introduce new
Access Immunoassay Systems assays or change existing assay protocols.
auto sample ID
A test request option that automatically assigns sequential sample IDs as you
manually enter test request information. After you enter the initial sample ID, the
system increments each subsequent sample ID by one until you exit the Test
Requests screen or you turn the auto sample ID option off.
B
bar code
An array of parallel rectangular bars of varied widths, which use a standard bar
code symbology to present sample and reagent information. The UniCel DxI
system reads bar codes on sample racks, reagent packs, substrate bottles, and
calibrator cards. The system can also read sample IDs from bar code labels on
sample containers.
Glossary-2 © 2022 Beckman Coulter, Inc.

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bar code reader

A device that scans and transfers bar coded information to a system that decodes
the information. The UniCel DxI system uses two handheld bar code readers: the
PC bar code reader and the substrate bar code reader. It also uses internal bar code
readers to scan bar codes on racks, samples, and reagent packs.
base plate
The surface beneath the reagent and sample pipettors. This is one of the nine
thermal zones monitored by the system. See also thermal zones.
batch request
A test request option that automatically assigns the test list from the previous
sample to the next sample as you manually enter test request information. The
system continues to assign the same tests to each subsequent entry until you exit
the Test Requests screen or you turn the batch request option off.
baud rate
The unit of measure of data transmission speed.
bound analyte
An analyte in an assay, which through attraction to a paramagnetic particle
becomes part of an immune complex. See also paramagnetic particles. For
contrast, see unbound analyte.
bubble detector
A device that detects the presence of air bubbles in liquid flowing through the
substrate line. Detection is based on the principle that light transmission in liquids
weakens when bubbles are present in the fluid.
bulk liquid waste container (optional)
A reusable container that holds waste fluid generated by the instrument during
processing. Two of these containers are stored inside the liquid waste drawer. The
instrument fills one container at a time. While one container is filling, the other
container can be changed.
bulk RV feeder
The device that moves empty RVs from the on-board supply to the supply
carriage. Components of the bulk RV feeder include the vessel hopper, where
RVs are loaded onto the instrument, and the vertical dispense chute, which
dispenses the RVs individually into a position in the supply carriage. Also see
vessel hopper, vertical dispense chute, and supply carriage.
bulk supplies
The large-volume supplies and waste containers that enable continuous
processing of the UniCel DxI instrument. The refillable supplies are substrate,
wash buffer, and RVs. Solid waste is collected in the solid waste container.
Liquid waste is drained to an external floor drain or to two on-board bulk liquid
waste containers. Bulk supplies can be monitored on the Bulk Supplies screen.

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bulk wash buffer container

A 10-liter container that holds the wash buffer that is used for various instrument
operations. Two of these containers are stored in the wash buffer supply drawer.
The instrument draws from one container at a time. While one container is in use,
the other can be changed.
C
calculated concentration
The concentration of analyte in a calibrator, as measured and calculated by the
system. For contrast, see stated concentration.
calibrator
One or more solutions that contain stated concentrations of analyte. Most
calibrators are multi-level, composed of more than one solution which span a
range of concentrations for an assay. Calibrators are tested on the system to
establish assay calibration curves or cutoffs. The system uses the assay
calibrations to calculate patient and quality control test results.
Whether you use calibrators or controls to calibrate an assay, the UniCel DxI
system and this documentation use the term calibrator to refer to these
components.
carryover
An amount of residual analyte carried on a pipettor from one sample to a
subsequent sample, thereby contaminating the subsequent sample. If the
carryover amount is significant, false positive patient reports may be reported.
The system provides a maintenance routine to test for carryover, which can be
performed to meet your laboratory requirements.
capture antibody
An antibody used to bind immune complexes to paramagnetic particles.
Complexes that are bound to the paramagnetic particles are separated from
unbound components by magnetism. See also antibody or paramagnetic
particles.
central processing unit (CPU)
The part of a computer or instrument that processes data. Both the external
computer (PC) and the instrument computer have CPUs.
chemiluminescence
The emission of light resulting from a chemical reaction.
Citranox cleaning solution
An industrial detergent used to clean appropriate parts of the instrument
according to documented UniCel DxI procedures.

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clean check
A system check that evaluates how effectively the instrument has washed the
Access System Check Solution from the UniCel DxI system. The clean check
cannot be requested. It is run automatically when the three System Check routines
are run together.
CLSI
The Clinical and Laboratory Standards Institute, a World Health Organization
(WHO) collaborative center for worldwide clinical laboratory standards and
accreditation, which publishes those standards according to consensus. Formerly
known as NCCLS.
coefficient of variation (CV)
A measure of the relative precision of a group of data points. The CV is
calculated by dividing the standard deviation by the mean. The CV is used to
measure the precision of different sets of data that have different means. The CV
is often calculated as the %CV, which is the CV multiplied by 100.
competitive binding assay
An assay in which a labeled analyte (the assay reagent) and an unlabeled analyte
(antigen in the test sample) compete for a limited number of binding sites on the
binding reagent.
concentration
The amount of analyte in a sample. See also stated concentration or calculated
concentration.
confirmatory assay
An assay that is run to confirm the results of a qualitative assay.
conjugate
The antigen or antibody component of a reagent that has an enzyme (alkaline
phosphatase) label attached to it. The substrate reacts with the conjugate present
in bound immune complexes, which results in chemiluminescence.
Contrad 70 cleaning solution
A solution used to clean or decontaminate appropriate parts of the instrument
according to documented UniCel DxI procedures.
control
See quality controls (QC).
corrupt
An item, such as data or a database, that is altered from its correct or original
form.
CPU
See central processing unit (CPU).

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critical range
A range of results determined by your laboratory, which may depend on
demographics, lab policy, or other factors. You configure critical ranges by test.
The system flags results that are out of range. See also reference range and LIS
range.
cutoff
The level of response which distinguishes a reactive from a non-reactive (positive
from negative) qualitative test. Cutoff values are established by assay
calibrations, and produce the point at which a result is determined clinically
significant, according to information provided in the reagent instructions for use.
CSF
An abbreviation for cerebrospinal fluid. This abbreviation is used as a sample
type on the UniCel DxI system.
CV
See coefficient of variation (CV).
D
Daily Clean System routine
A maintenance routine that cleans the sample, reagent, and aspirate probes. The
routine is run once every 24 hours as a part of daily maintenance if you are not
running the vitamin B12 assay. See also Special Clean routine.
daily maintenance
Instrument maintenance that you perform each day prior to beginning your daily
workload. Daily maintenance consists of procedures for cleaning and preparing
the system to process samples each day. See also test interval maintenance.
dark count
The background light that is present in the instrument when there is no RV in
front of the luminometer. Dark counts are measured in RLUs. High dark counts
affect results. An event is generated for results with high dark counts.
dead volume
The amount of sample in a sample container that is not available for processing
and must be included in the sufficient sample volume calculation.
deflection
The movement of a structural component in response to stress. After aspirate
probes are installed, deflection is tested by lifting and then releasing the probe.
With proper deflection, the probe snaps back into position.
deionized (DI) water
The purified water created by removing ions through ion exchange. You use
deionized water to clean appropriate parts of the instrument according to
documented UniCel DxI procedures.

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demographics
The characteristics of patient populations, such as age, sex, weight, height, and
other physical attributes.
derived result
A calculated result that is generated when a test result is operated on by a derived
result formula. Derived result formulas are either predefined in the APF or are set
up according to laboratory preference. Derived results are included on the test
result reports and they can be sent to the LIS.
detection phase
The part of an assay in which the immune complexes that are bound to
paramagnetic particles (in the solid phase) are detected by adding substrate and
measuring the resulting chemiluminescence.
dioxetane
A chemiluminescent compound that is activated by alkaline phosphatase.
Dioxetane is the light producing portion of the substrate. See also substrate.
dispense chute
See vertical dispense chute.
dispense probe
A probe through which wash buffer is dispensed into RVs to wash the
paramagnetic particles. Dispense probes are removed and inspected at
recommended intervals during routine maintenance.
download
The transmission of data from a host computer, usually by an LIS to the
UniCel DxI system. See also host query.
drift correction factor
A multiplier applied to the luminometer output, which accounts for small changes
to the photomultiplier tube as it ages.
duck bill valve
The duck bill valve prevents wash buffer from entering the RVs in the wash
carousel during the aspirate probe wash. The duck bill valve is replaced at
recommended intervals during routine maintenance.
duty cycle
The relationship between the operating and rest times of a device. For example, a
duty cycle of 23 for a device means that the device runs 23 percent of the time
that the instrument is on.

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E
e format
A method of expressing numbers with many digits by placing the decimal to the
right of the first single digit, by rounding the last digit to the right of the decimal,
and by indicating the number of places right (-) or left (+) that the decimal shifted
from the original number. For example, the 11-character number 12345678.99 is
expressed as the 10-character number 1.235e+007 in e format. The UniCel DxI
system uses e format in some calculated fields.
EIA 232
A standard of the Electronic Industries Alliance that specifies the characteristics
of the serial communications line. The serial communications line is used to
connect the UniCel DxI system to an LIS. Formerly known as RS 232. See also
laboratory information system (LIS).
equivocal zone
See gray zone.
error band
The calculated acceptable limits of variability around a calibration curve.
event details
The technical information you can display for an event. Technical Support may
use the event details to troubleshoot the instrument if you contact them for
assistance.
Event Log
A list of events that the UniCel DxI system generates as it monitors the status of
various system parameters. An event can be one of three types: information,
caution, or warning. Some warning events are also fatal events, which stop the
system from further processing. See also fatal event.
external computer (PC)
The personal computer that is connected to a UniCel DxI system. The PC has its
own hard disk, 3.5-inch (8.9 cm) disk drive, CD-ROM or DVD drive, modem,
and tape or USB flash drive. The following peripheral devices are connected to
the PC: touchscreen monitor, keyboard, printer, mouse, and PC bar code reader.
The PC also includes the port for connecting to the LIS.
F
fatal event
A condition that stops the UniCel DxI system, or a portion of the system, and
must be corrected before the system can continue processing samples. Fatal
events are recorded in the Event Log. See also Event Log.

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fatal flag
A flag applied to a test result when the system encounters a condition that may
cause the result to be invalid. The system suppresses these test results.
filter
A software mechanism that you can use to control the quantity and organization
of the data displayed on a screen, printed on reports, or saved to disk. You can
limit the data to certain types, dates, or ranges of dates, and sort the data
according to parameters provided by the filter.
flag
A code that the UniCel DxI system attaches to a test result when a special
circumstance requires your attention.
G
gray zone
A range of values (up to 20%) above and below the cutoff value of a qualitative
assay. The system can be configured so that it flags results in the gray zone
(GRY). The GRY flag indicates that the result is near the cutoff. A gray zone may
also be called an "equivocal zone".
H
heterogeneous assay
An assay that requires the separation of bound labeled material from unbound
labeled material. All Access Immunoassay System assays are heterogeneous
assays.
home position
A set starting position for any instrument device. Restarting the instrument resets
the UniCel DxI system software and returns devices to their home positions.
hopper
See vessel hopper.
host query
An information request sent from the UniCel DxI system to the LIS for new test
requests. When host query is enabled, the UniCel DxI system queries the LIS for
test request information instead of waiting for a download. See also download.
I
immune complex
An antigen and antibody that are physically bound together.
immunoassay
An analytical method that depends on the antigen-antibody reaction to detect the
substance being measured in a sample of body fluid, such as serum or plasma.

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incubator
The temperature-controlled area inside the instrument that holds up to 258 RVs,
each for the time required for a reaction to occur between the sample and the
reagent.
indicator light
See status indicator light.
initialization
A routine that resets the UniCel DxI system software, and brings all devices to a
known safe state. Initialization prepares the system for further processing.
Specific initialization options are required for different kinds of initialization. If
you are uncertain about the initialization options, confirm your selections with
Technical Support.
insert cup
A type of sample container that you place within another sample container and
then in a sample rack. See also sample container.
instrument software
The software program that controls the motion of devices and the production of
results within the instrument. Results are transferred from the instrument software
to the user interface. See also user interface (UI).
interlock switch
A safety feature designed to protect you from injury.
L
laboratory information system (LIS)
A computer system that manages the workflow in a clinical laboratory from
collecting specimens to creating patient reports. The LIS interfaces with the
UniCel DxI system to provide test request information and receive results.
last run calibration
The results of the most recent calibration request, which either passed or failed.
Levey-Jennings chart
A graphical representation of quality control test results that shows each result as
a point on, above, or below the expected mean result in distances measured in
units of standard deviation (SD) between -3 SD and +3 SD.
liquid waste container
See bulk liquid waste container (optional).
LIS
See laboratory information system (LIS).
LIS interface
The connection between the UniCel DxI system and the LIS.

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LIS range
A range of results to be sent directly to the LIS, as determined by your laboratory
and configured by test. The system holds out-of-range results for your review.
See also critical range and reference range.
LIS workpool
A list of pending test requests that were downloaded from the LIS. Downloaded
test requests remain in the LIS workpool until their corresponding sample
containers are loaded on the instrument, scanned by the SPU bar code reader, and
scheduled for processing. See also work pending.
luminometer
The device that measures the amount of light in relative light units (RLUs)
produced by the chemiluminescent reaction in RVs.
M
maintenance log
A form on which you record the completion of routine maintenance procedures.
maintenance routine
One of the cleaning, checking, or matching routines that can be run as a
maintenance request in order to maintain the instrument or to verify its
performance.
math model
The mathematical formula defined in the APF that the UniCel DxI system uses to
fit assay calibration data to a curve.
methanol
A light, volatile, and flammable poisonous liquid alcohol (CH3OH). It is used to
clean appropriate parts of the instrument according to documented UniCel DxI
procedures.
minimum sample volume
The amount of sample required to minimize the effects of evaporation and to
allow for factors that can cause variations in sample height, such as clot or gel
height, in a sample container.
N
NCCLS
See CLSI.
non-fatal event
A condition that does not stop the UniCel DxI system, but is posted to the Event
Log, and should be examined before the system continues processing samples.
non-fatal flag
A flag applied to a test result when the system encounters a notable condition.
The system does not suppress these test results.

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non-volatile random access memory (NVRAM)

A data storage area that maintains critical system information. The information is
maintained when the power is off.
NVRAM
See non-volatile random access memory (NVRAM).
O
obstruction detection
The process monitoring activity that the system uses to detect clots or other
obstructions in the sample pipettor during aspiration and dispensing. When an
obstruction is detected, the system generates an event. An attempt may be made
to recover from the problem, or the system may reject the sample. See also
process monitoring.
off board
The location of a bulk supply or reagent pack when it is not loaded on the
instrument. This term is not used for samples or racks.
offload area
The area of the sample presentation unit (SPU) that moves sample racks away
from the sample aliquot station. Sample racks accumulate in the front and side
offload areas, awaiting removal by the operator.
on board
The location of a bulk supply or reagent pack when it is loaded on the instrument.
This term is not used for samples or racks.
one-step assay
An immunoassay that mixes assay-specific reagent with the sample in one
processing stage, and requires only one incubation period. See also two-step
assay.
onload area
The area of the sample presentation unit (SPU) where you load sample racks for
processing.
override
A feature that allows the system to start sample processing using expired supplies
or calibrations. You can override expired supplies and calibrations from the
Supplies Required screen, or you can set up your system to automatically
override expired supplies and calibrations. The system flags test results obtained
using expired supplies or calibrations.
P
P&P
See pick and place (P&P).

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panel icon
See system status panel (UniCel DxI 800 instrument only, if equipped).
paramagnetic particles
Small particles of ferrous material surrounded by cellulose or polystyrene and
coated with capture antibodies or antigen. The particles are used in the solid
phase of assays to bind to immune complexes. Magnetism is used to separate
bound complexes from unbound components.
PC
See external computer (PC).
Peltier
See reagent Peltier device.
pick and place (P&P)
A device used to pick up RVs from one location and place them in another
location. The pick and place may move the RV to a new position, or another
device may move into the location under the pick and place.
pipettor matching
See reagent pipettor matching.
power switch
The UniCel DxI system has two power switches. One is for the PC and the other
is for the instrument. Be sure to follow the appropriate PC or instrument shut
down procedures before turning off the power.
precision profile
The method that the UniCel DxI system uses to determine if a quantitative or
semi-quantitative assay calibration meets the acceptance criteria defined in the
APF. See also acceptance criteria.
previous active calibration
The calibration that was previously the active calibration. You can switch the
previous active calibration to the active calibration.
primary test
The test name on a reagent pack. Some assays can provide a secondary test from
the same reagent pack, such as Folate (primary) and RBC Folate (secondary).
prime fluidics (priming)
To fill the fluidic lines with liquid and eliminate air in the lines, which ensures
that the system dispenses and aspirates accurate volumes.
process monitoring
A feature that the system uses to monitor the activity of all subsystems involved
in handling and processing samples. The system monitors instrument
temperatures, moving components, fluidic movements, and luminometer outputs.
The system also detects sample obstructions. If a failure occurs, one or more

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events are generated and, depending on the severity of the failure, the system may
stop processing the sample or stop running. See also obstruction detection.
Q
QC
See quality controls (QC).
QC rule
See Westgard QC rule.
qualitative assay
An assay that establishes a calibration cutoff that the system uses to classify
samples as reactive or non-reactive for an analyte. See also cutoff.
quality controls (QC)
Samples of known concentration, composed of a material similar to patient
samples, which are run along with patient samples to monitor system
performance.
quality control (QC) calculations
The comparison of results to the acceptable range of expected values you entered
during QC setup. QC calculations include the mean (average) test result value,
the standard deviation (SD) from the mean, and the percent coefficient of
variation (%CV).
quantitative assay
An assay that establishes a calibration curve that the system uses to convert
sample RLU (relative light unit) readings to an analyte concentration, and to
express the result in incremental units.
R
rack
See sample rack.
reaction vessel (RV)
A plastic, 1 mL ringed container used to process tests on the UniCel DxI
instrument. Reaction vessels (RVs) are dispensed into the instrument from the
vessel hopper. RVs are used to hold sample, to make sample dilutions, or to
combine patient sample and assay-specific reagent to produce a chemical reaction
that is measured as the test result.
reagent
A substance used to perform an assay. Access Immunoassay Systems reagents
include conjugate, paramagnetic particles, and other assay-specific reagents such
as antigens or antibodies specific for the analyte being detected, stripping agents,
or buffered protein solutions.

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reagent carriage
One of four electromechanical devices that receive RVs from the sample storage
area and present them to the reagent pipettors, which transfer sample to another
RV and add reagent. For two-step assays, a reagent carriage receives the RV
again after incubation, and presents it to the reagent pipettors for additional
reagent. See also reagent pipettor (RP).
reagent inventory
A system process that defines and tracks information about reagent packs. You
can view the reagent name, lot number, serial number, number of tests left, pack
expiration date, calibration expiration date, and slot position (if the pack is on
board the instrument) for each reagent pack from the Reagent Inventory screen.
reagent pack
A container that holds up to five assay-specific reagents in separate
compartments. Reagent packs are stored on the instrument in the reagent storage
chamber, and are automatically moved to the reagent aliquot station as they are
needed. The operator adds reagent packs to the storage chamber from the reagent
load area. The system automatically discards empty reagent packs in the solid
waste container.
reagent Peltier device
One of three devices that use electrical current to create both heated and cooled
surfaces. The cooled surface of the devices are used to maintain the reagent
storage area temperature. Named for Jean C. A. Peltier, the French physicist who
discovered the Peltier effect of thermoelectricity.
reagent pipettor (RP)
One of four devices that aspirate and dispense specific amounts of sample and
reagent into a single RV for processing all replicates of a requested test.
reagent pipettor matching
A routine that matches the delivery volume from the four reagent pipettors.
Matched pipettors can be used interchangeably when processing calibrators,
controls, and patient samples for an assay. The matching routine is run
immediately after the instrument is manufactured and thereafter as directed by
Technical Support.
reagent storage chamber
A refrigerated internal chamber with 50 slot positions for storing reagent packs at
an optimum temperature until they are needed for processing tests. When a
reagent pack is needed, the system moves the pack from its slot to an available
reagent aliquot station, and then returns it to an open slot. If the pack is empty, it
is transported to the solid waste container.
reagent supplies
On board reagent packs. See also reagent pack and reagent inventory.

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real-time
In the same time frame. Real-time responses or file updates occur immediately.
For example, if you display the Maintenance Review screen over a long period of
time, thermal zone temperatures change to the current reading in real-time. You
do not need to refresh the screen to view the most current reading. See also
refresh.
reference range
The range of expected test result values for a normal demographic population, as
configured by your lab. The system flags results that are out of range. See also
critical range and LIS range.
reflex test
A test that the system runs automatically in response to one or more test results
that meet conditions set up by your laboratory. The test runs using the reserve
volume of sample stored on the instrument when the reserve volume feature is
enabled. If sufficient sample is not on board, the test is added to the work pending
list until more sample is loaded on the instrument.
refresh
To update the information that is not updated in real-time on a screen or in a
window. To refresh the information, you can exit the screen and display it again.
As an alternative to exiting the screen, a few screens provide refresh buttons. See
also real-time.
relative light unit (RLU)
A unit of measure used to express the amount of light reaching the luminometer.
replicate
The multiplier for the number of times a test is run on the system. Tests are run in
replicates of 1, 2, 3, and so on.
reserve volume
An additional volume of sample that is drawn from a QC or patient sample and is
stored on the instrument for processing tests not initially requested for the sample.
reset button
A button that tells the software that the emptied solid waste container is again on
board. The button, which is behind the solid waste door, must be pressed by the
operator or the system will continue to track the solid waste container as filling.
RLU
See relative light unit (RLU).
robotic module
One of several modules that move RVs and reagent packs from one area of the
instrument to another.

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RP
See reagent pipettor (RP).
RV
See reaction vessel (RV).
RV feeder
See bulk RV feeder.
S
sample
The material that you load on the instrument for processing.
sample aliquot station
The area of the sample presentation unit (SPU) where the instrument scans rack
and sample container bar codes, and then aliquots sample for processing. After
samples are aliquoted, the sample racks move to the offload area of the SPU. See
also sample presentation unit (SPU) and offload area.
sample container
A container that can hold a defined volume of sample material. There are two
classes of sample containers: sample cups and sample tubes. Most sample
containers are placed directly into sample racks for processing.
sample cup
See sample container.
sample pipettor (SP)
A device that transfers a measured aliquot of sample from a sample container in a
rack in the sample aliquot station to one or more RVs for processing. See also
sample aliquot station.
sample presentation unit (SPU)
The area of the instrument where an operator loads sample racks for processing
and unloads racks after they have been aliquoted by the instrument. Racks can be
loaded and unloaded at any time without interrupting sample processing.
sample processing
The process of running a test on an aliquot of sample, and then generating the test
result for that patient sample, quality control, or calibrator. Sample processing
begins when the system downloads test requests from an LIS, or when an
operator enters a request on the Test Requests screen.
sample rack
A frame for holding sample containers, which you use to load samples on the
instrument. Each rack holds up to four sample containers, and the instrument
holds up to 30 racks in the onload area of the sample presentation unit (SPU).
Laboratories assign and configure ranges of rack IDs for different types of sample
containers.

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sample tube
See sample container.
sample type
The type of body fluid being analyzed, such as serum, urine, or plasma.
sample wheel
The area inside of the instrument where sample aliquots are stored. This is one of
the nine thermal zones monitored by the system. See also thermal zones.
sandwich assay
An assay in which unlabeled analyte (antigen in the test sample) is sandwiched
between an antibody bound to the paramagnetic particles and a labeled antibody
(conjugate).
secondary test
An alternative format for a test that uses the same reagent pack as the primary
test. For example, RBC Folate is a secondary test for Folate.
semi-quantitative assay
An assay that establishes a calibration curve that the system uses to convert
sample RLU (relative light unit) readings to analyte concentrations, and then to
interpret the sample results as reactive, non-reactive, or equivocal.
solid phase
The processing stage of an assay in which the immune complexes bind to
paramagnetic particles and are then separated from unbound materials. See also
paramagnetic particles.
solid waste container
A large plastic bin lined with a biohazardous waste bag, stored behind the solid
waste door. The container collects empty or expired reagent packs, used RVs, and
condensation generated during processing. The contents of the container are
biohazardous and should be disposed of according to proper laboratory
procedures.
sort order
The order that items are displayed on a screen or on a report. For example, you
can sort test results by sample ID, then by completion time in ascending (0-9) or
descending (Z-A) sort order.
SP
See sample pipettor (SP).
Special Clean routine
A maintenance routine that cleans and prevents the buildup of debris on the
sample, reagent, and aspirate probes. The routine is run during daily maintenance
if your lab has run the Vitamin B12 assay in the last 24 hours. See also Daily
Clean System routine.

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special weekly maintenance

Routine maintenance that is performed weekly to clean the aspirate probes on
instruments that run tests for HIV antibodies. Laboratories that install clean
aspirate probes during special weekly maintenance are not required to install
clean probes based on test interval maintenance. See also daily maintenance and
test interval maintenance.
SPU
See sample presentation unit (SPU).
stated concentration
The concentration of analyte material in the calibrator level, as stated on the
calibrator card. For contrast, see calculated concentration.
status indicator light
One of four lights aligned vertically on the front panel of the instrument. An
indicator light is lit or blinks to indicate the instrument operating status or the
need for operator attention. The indicator lights are system indicators of the
following system statuses:
• Red: the system is stopped.
• Amber: the system has a supply condition that requires attention.
• Green: the system is running.
• Blue: the system is ready to run.
For entries about other system indicators, see system status button and system
status panel (UniCel DxI 800 instrument only, if equipped).
substrate
A substance acted upon by an enzyme. In an Access Immunoassay System assay,
the substrate is a dioxetane-based chemiluminescent compound that emits light in
response to the amount of alkaline phosphatase (enzyme) to which it is exposed.
substrate : washed ratio
A calculation based on the system check results from the Substrate and Washed
routines when all System Check routines are run together. A failed
substrate : washed ratio could be caused by an improperly performed System
Check routine, or by contaminated substrate. See also System Check routines.
substrate check
See Substrate routine.
substrate probe
A probe that dispenses substrate into RVs to initiate a chemiluminescent reaction.

C95318-AA
substrate ratio
A calculation based on results from the Substrate routine. A failed substrate ratio
is indicative of a compromised waste system. To get a substrate ratio result, you
must run all of the System Check routines together. See also System Check
routines.
Substrate routine
An individual System Check routine that evaluates the performance of the
substrate dispense system and luminometer. See also System Check routines.
supply carriage
A device that receives up to three RVs from the bulk RV feeder and carries them
to a pick and place position. The pick and place device removes the RVs
individually from the supply carriage and places them in the sample wheel for
sample aliquots or in a reagent carriage for test aliquots or sample dilutions. Also
see bulk RV feeder and pick and place (P&P).
supplies
The stock items that are used up or filled up by the UniCel DxI instrument while
it processes tests. Most supplies are bulk supplies, which keep the instrument
running for long periods of time without requiring attention. Also see bulk
supplies or one of the individual supply glossary entries: bulk liquid waste
container (optional), reagent pack, solid waste container, substrate, reaction
vessel (RV), or wash buffer.
System Check routines
Three individual maintenance routines that verify the wash efficiency and
pipetting precision of the UniCel DxI system. You run System Check routines as
instructed by system documentation or as directed by a technical support
representative.
system console
The part of the instrument that includes the external computer, keyboard, mouse,
touchscreen monitor, printer, PC bar code reader, and port for connecting to the
LIS.
system indicators
One of three sets of indicators that inform the operator that the system needs
attention. For more information, see the status indicator light, system status
button, and system status panel (UniCel DxI 800 instrument only, if equipped)
entries.
system mode
The operational state of the UniCel DxI system displayed in the upper left corner
of each screen. The four system modes are Ready, Running, Paused, and Not
Ready. For information about individual modes, see Chapter 1: System Overview
in the Operator's Guide.

C95318-AA
system status button

One of six round buttons in a horizontal line at the upper right of each UI screen.
The buttons change colors to indicate when a problem occurs with a rack, one or
more tests cannot be processed (see work pending), calibrations are required,
supplies are needed or waste containers are full, QC samples have failed, or
caution or warning events need to be reviewed. The operator can select a button
to view a screen with more information about the status. For information about
the individual buttons, see Chapter 1: System Overview in the Operator's Guide.
system status panel (UniCel DxI 800 instrument only, if equipped)
A group of system status icons located on the horizontal panel directly below the
status indicator lights. The panel icons are arranged on a picture of the
instrument, to indicate the area of the instrument that requires attention. Blinking
or solid lit icons indicate a system requirement. Five of the six panel icons (such
as the RVs icon or the liquid waste icon) are related to supply needs which the
operator can meet by adding or removing supplies from the instrument without
consulting the UI software. The console icon indicates that the operator needs to
view the UI for supply or processing information.
T
test interval maintenance
Routine maintenance on the instrument that is performed after a specific number
of tests have run. See also daily maintenance.
test list
The list of tests requested for a given patient sample or quality control.
test panel
On the UniCel DxI system, a group of two or more tests that can be run from one
test request. You define test panels on the system, according to your laboratory
needs. Test panels cannot be requested through an LIS.
test request
The sample and test request information downloaded from the LIS, or manually
entered by an operator on the Test Requests screen.
test result
The analyte concentration in a sample, or the designation of a sample as reactive
or nonreactive. The system calculates the test result by comparing the RLU
measurement to a calibration curve or cutoff value.
test result flag
See flag.

C95318-AA
test state
Status of a given test, as displayed on either the Test Results or the Sample
Manager screen. The status value indicates the current stage of processing for a
patient sample, quality control, or calibrator.
thermal zones
Nine areas of the instrument that are cooled or heated by temperature control
devices.
troubleshooting Help
The online troubleshooting information from the UniCel DxI Help system that
you can display for a test result flag by selecting Troubleshoot F2.
two-step assay
An immunoassay that mixes assay-specific reagent with sample at two different
stages of processing, and requires incubation after each reagent addition. See also
one-step assay.
U
UI
See user interface (UI).
ultrasonic transducer
The instrument device on each of the reagent pipettors that applies ultrasonic
vibrations to the tip of the probe. These vibrations mix reagents in the reagent
pack before sampling, mix the contents in the RV, clean the probe after each use,
and sense the level of the sample fluid.
unbound analyte
The analytes in an assay that are not bound to paramagnetic particles. See also
paramagnetic particles. For contrast, see bound analyte.
unwashed check
See Unwashed routine.
Unwashed routine
An individual System Check routine that evaluates the precision of the reagent
pipettors. See also System Check routines.
upper cabinet
The area behind the main upper covers that contains many of the instrument
modules. This is one of the nine thermal zones monitored by the system. See also
thermal zones.
user interface (UI)
The software you use to interact with and direct the instrument software. The UI
contains sample database, calibration, quality control, and LIS information, as
well as the assay protocol file (APF). The UI software is stored on the hard drive
of the external computer (PC). See also instrument software.

C95318-AA
Utility routine
A maintenance routine that flushes the probes and fluidic lines after the system
completes processing a continuous run of samples. If the Utility routine is
enabled, it runs every four hours when the system is not processing samples. You
can run the routine manually when additional cleaning is requested by Technical
Support or required for troubleshooting.
V
verbosity
In software terms, the level from concise to comprehensive at which information
is recorded in internal log files. The more comprehensive the record, the greater
the verbosity. The system may automatically check and adjust the system
verbosity level during installation. Occasionally, the user interface may prompt
you to reset the level of verbosity to the default level on the PC Admin screen.
vertical dispense chute
The component of the bulk RV feeder that receives individual empty RVs, which
have been vertically oriented to receive sample, and provides them a downward
path for dispensing into the supply carriage. Also see bulk RV feeder and supply
carriage.
vessel
See reaction vessel (RV).
vessel hopper
The receptacle behind the hopper door which holds up to 2,000 RVs. RVs in the
hopper are automatically fed into the instrument when needed for processing.
W
wash buffer
The buffered solution used by the UniCel DxI system to remove unbound
material during processing, to wash the probes, to prime the system, and for some
assays, to dilute sample. The UniCel DxI system holds two bulk wash buffer
containers. See also bulk wash buffer container.
wash carousel
A rotating ring that holds up to 69 RVs. As the wash carousel rotates, it moves the
RVs into positions to be washed of unreactive material, read by the luminometer,
and then removed from the system.
wash efficiency
A calculation based on the results from the Washed, Substrate, and Unwashed
routines. To obtain a wash efficiency result you must run all of the System Check
routines together. See also System Check routines.

C95318-AA
washed check
See Washed routine.
Washed routine
An individual System Check routine that evaluates the performance of the RV
wash and mixing systems. See also System Check routines.
Westgard QC rule
One of a set of interpretive rules that the system uses to avoid excessive false
rejection rates, to improve quality monitoring, and to decrease subjectivity of data
analysis. (Also called Westgard rules or QC rules.)
The application of a Westgard QC rule consists of screening quality control test
results for an amount of standard deviation above or below the mean, and the
number of consecutive occurrences. For example, the 41S rule checks for 4
consecutive results that exceed ±1 SD from the mean. Your laboratory determines
the QC rules to apply and the course of action you need to take when a result
violates a rule.
The UniCel DxI system uses five Westgard QC rules (12S, 13S, 22S, 41S, 10X).
work pending
A list of pending test requests that the UniCel DxI system cannot schedule for
processing because the samples are missing. These test requests remain in work
pending until their corresponding sample containers are loaded on the instrument,
scanned by the bar code reader, and scheduled for processing. See also LIS
workpool.
workpool
See LIS workpool.

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UniCel DxI Reference Manual Index
Index
assay protocol file
A see APF
alignments assays
diagnostics 4-38 assay protocol file (APF) 3-4
screen 4-38 technology overview 1-5
viewing information 4-41
ASTM standard protocols 2-30
altitude requirements A-4
auto-delete feature 2-35, 2-40
analog devices
auto-trim feature 2-35
diagnostics 4-26
viewing sensor information 4-26
B
analytical performance 1-10
backup power supply A-6
antibody detection assays 1-8
backups
APF automatic 2-41
calibration acceptance criteria 1-20 flash drive 2-36
calibration acceptance limits 1-22 immediate 2-45
event troubleshooting 5-16 running 2-41
new tests 3-4 scheduling 2-36, 2-41
removing tests 3-4 scheduling (flowchart) 2-44
test definitions 3-4 start time caution 2-43
updating 3-4 system overview 2-36
aspirate probes tape 2-36, 2-45, 2-46
priming probe 1 4-12 USB flash drive 2-45
assay calibration theory bar code labels
acceptance criteria 1-20 attaching to racks 2-22
acceptance limits 1-22 reagent troubleshooting 5-22
calibration failures 1-20, 1-22 sample container specifications A-15
calibration types 1-19 bar code readers
fitting to a curve 1-20 PC properties A-12
overview 1-18 performance properties A-12
predicted precision 1-21, 1-22 reagent properties A-13
qualitative 1-22 SPU default settings A-13
quantitative 1-20 SPU properties A-13
semi-quantitative 1-20 SPU setup 2-25, 2-28
assay calibrations substrate properties A-12
troubleshooting event 5-17 symbology setup 2-28
assay characteristics 1-10
© 2022 Beckman Coulter, Inc. Index-1

C95318-AA
Index UniCel DxI Reference Manual
bar code symbologies carryover testing

character parameters 2-27 carryover screen 4-46
check digit parameters 2-26 diagnostics 4-43
codabar 2-25, A-13 preparation 4-44
code 128 2-25, A-14 required materials 4-43
code 39 2-25, A-14 results 4-45
code 93 2-25, A-14 running 4-43
error checking 2-29 troubleshooting 5-19
interleaved 2 of 5 2-25, A-14 caution events 5-5
parameter setup 2-25 without troubleshooting 5-13
bubble detector cautions
priming 4-13 description - Preface-3
priming failure 4-14 chemiluminescence 1-5, 1-6
bulk RV feeder clean routines
event troubleshooting 5-16, 5-17 event troubleshooting 5-18
cleaning
C
offload rack sensor (DxI 800 only) 6-49
calibration curves rack sensors 6-47, 6-48
error bands 1-21 sample probe 6-30
math models 1-20 SPU 6-48
precision profile method 1-20 SPU side offload area (DxI 800 only)
predicted precision 1-21 6-49
theory 1-20 cleaning a sample probe 6-30
calibration cutoffs clot detection 1-11
acceptance limits 1-22
communication error troubleshooting 5-18
theory 1-22
competitive binding assays 1-6
calibration data
configurations
auto-delete 2-35
derived results 3-35
replicates 1-22
reflex tests 3-44
calibration theory
results 3-3
see assay calibration theory
system setup 2-3
calibrations test 3-3
assay 1-18 test panels 3-25
device 1-24 test setup 3-5
event troubleshooting 5-33, 5-38, 5-40
confirmatory assays
liquid waste sensors 4-30, 4-33
screening assays 1-23
luminometer 1-24
theory 1-23
pressure sensor 1-24, 4-28
covers
sensor 1-24, 4-30, 4-33
before opening 6-5
substrate drawback 1-24, 4-10
closing main upper 6-7
ultrasonics 1-24
lock release 6-12
wash buffer sensors 4-30, 4-33
main upper 6-4
capacities
opening caution 6-5
database A-10
opening left upper 6-5
sample racks A-11
opening right upper 6-7
supplies A-11
Index-2 © 2022 Beckman Coulter, Inc.

C95318-AA
procedures 6-4 device

reagent storage location 6-51, 6-52 alignments 4-38
critical ranges 3-19 analog 4-26
calibrations 1-24
D diagnostics 4-26
dark count troubleshooting 5-18 digital 4-26
homing 4-42
data management
initialization 4-6
auto-delete setup 2-40
mechanical 4-38
automatic backups 2-41
database 2-46 diagnostic events 5-5
immediate backups 2-45 diagnostics
overview 2-35 alignments 4-38
system backups 2-36 analog devices 4-26
database carryover testing 4-43
auto-delete 2-35, 2-40 digital devices 4-26
auto-trim 2-35 fluidics 4-10
capacities A-10 mechanics 4-38
maintenance 2-46 menu 4-3
management 2-35 overview 4-3
restore erases data 2-46 priming fluidics 4-10
pump statuses 4-36
date
remap reagent packs 4-8
format setup 2-10
substrate priming information 4-13
system setup 2-10
system checks 4-15
dead volumes
system initializing 4-6
reserve volume theory 1-12
testing indicator lights 4-35
decimal places setup 3-10 wash efficiency 4-25
decontaminate digital devices
substrate system 6-24 diagnostics 4-26
demographic ranges 3-21 dilution factor
derived results onboard dilution theory 1-13
adding 3-39 special dilution setup 3-16
deleting 3-42 dilution test
editing 3-41 onboard 1-13
formula test 3-41, 3-42 special 1-13
formula warning 3-36, 3-41, 3-42
dimensions
formulas 3-35, 3-36
instrument A-2
naming 3-40
disabling all
operations sequence 3-36
reflex tests 3-60
operators 3-36
overview 3-35 dispense probes
range reports 3-23 priming 4-12
ranges setup 3-21 DxI system
screen 3-37 documentation - Preface-2
setup 3-35 technology overview 1-3
setup report 3-42

C95318-AA
processing with 1-15

E
external computer
EIA-232 electrical line A-5
LIS technology 1-4
electrical F
exposed metal warning 6-4 filters
instrument line requirements A-4 event log 5-6
PC line requirements A-5 test panels 3-27
power consumption A-5 tests (setup) 3-8
specifications A-4
find function
surge suppressors A-6
event log 5-7
enabling all
flowcharts
reflex tests 3-60
backups 2-44
environmental requirements A-4 event troubleshooting 5-14
equivocal zone system check routines 4-24
see gray zones 3-13 test panels 3-31
errors fluidics
see events priming 4-10
event log probe drawback troubleshooting 5-18
button 5-5 support procedures 6-24
filter 5-6
overview 5-2 G
printing 5-5, 5-8 gray zones
report 5-8 definition Glossary-9
reviewing 5-5 limits 3-15
screen 5-2 setting up 3-13
sorting 5-8 ground requirements A-4
events
alphabetical list with troubleshooting H
5-15
hardware revision information 2-10
event log 5-2
Help
finding 5-7
System - Preface-2
in blue 5-5
printing details 5-12 help
troubleshooting 5-11 system documentation - Preface-2
troubleshooting (flowchart) 5-13 technical support - Preface-3
troubleshooting by event 5-15 homing a device 4-42
troubleshooting overview 5-13 host query LIS setup 2-33
variable information 5-15 humidity A-4
viewing details 5-12
expired calibrations I
overriding all 2-18 immunoassays
processing with 1-15 antibody detection 1-8
expired sample 1-17 competitive binding 1-6
expired supplies sandwich 1-7
overriding all 2-18 technology 1-5

C95318-AA
incubator LAS
event troubleshooting 5-42 reserve volume 1-12
information events 5-5 reserve volume setup 3-52, 3-53
initialize system 4-6 level sense failure 5-34
cleanout RVs 4-8 light requirements A-4
not successful 4-6 lights
remap reagent packs 4-8 testing panel 4-35
installation liquid waste
APF 3-4 sensor calibration 4-30, 4-33
Instructions for Use - Preface-2 supply setup 2-16
Instrument - Preface-2 LIS
Instrument ASTM standards 2-30
Instructions for Use - Preface-2 event troubleshooting 5-20, 5-24
instrument global interface 2-32
clearance A-2 host query setup 2-33
cover lock 6-12 interface 1-4
cover procedures 6-4 interface setup 2-30, 2-31
diagnostics 4-3 local interface 2-32
dimensions A-2 ranges 3-19
electrical line A-4 send results by sample 2-34
extended shut down 6-19 send results by test 2-34
initializing 4-6 locks
operating characteristics A-8 SPU cover 6-12
performance A-8 luminometer
power switch 6-18, 6-20 calibration 1-24
priming fluidics 4-10 drift A-9
restart 6-14, 6-20 precision A-9
restart after extended shut down 6-21
shut down 6-14, 6-18 M
SPU lower panel procedures 6-8 main upper covers 6-4
support procedures 6-3
maintenance
temperatures A-9
after extended shutdown 6-23
UPS A-6
database 2-46
weight A-3
system check routines 4-22
insufficient sample
Manuals
troubleshooting 5-21, 5-22
Instrument Instructions for Use -
Preface-2
L Operator’s Guide - Preface-2
labels Material Safety Data Sheets - Preface-2
attaching to racks 2-22
mechanics
sample container specifications A-15
diagnostics 4-38
laboratory automation system
menus
see LAS
configure 2-4
laboratory information system diagnostics 4-4
see LIS
language selection 2-9

C95318-AA
surge suppressor A-6

O UPS A-6
obstruction detection 1-11 percent fluid detected 4-14
event troubleshooting 5-16
peripheral
onboard dilution device weights A-3
pick and place
parent test theory 1-13
pipettor assignment 3-16
pipettor assignment
processing theory 1-13
see reagent pipettors
reflex tests 1-13, 3-44
setting up units of measure 3-11 power
special dilution tests 1-13 instrument backup supply A-6
test names 1-13 instrument switch 6-18, 6-20
test setup 3-9 PC backup supply A-6
PC switch 6-15
onboard dilution test 3-9
power supply
Operator’s Guide - Preface-2
electrical line requirements A-4
instrument backup A-6
P
PC backup A-6
panels
UPS A-4
see test panels
precision profile method 1-20
paramagnetic particles 1-5, 1-6
pressure sensors
parent test
determining curve 4-28
assays with onboard dilutions 1-13
of dilution assay 3-9
viewing information 4-26
parent test of dilution assay 3-9
priming fluidics
password protected after extended shut down 6-22
auto-delete setup 2-40 aspirate probe 1 4-12
backups 2-45 calibrate drawback 4-12
instrument shutdown 6-18 cycles requested 4-13
LIS send mode 2-34 dispense probes 4-12
password changing 2-12 monitoring substrate information 4-13
PC restart 6-15, 6-16, 6-17 overview 4-10
running backups 2-41 percent fluid 4-14
scheduling backups 2-41 reagent pipettors 4-12
system administration 2-12 sample pipettor 4-12
patient samples substrate 4-12
database auto-delete 2-35 wash buffer bubble detector 4-13
database auto-trim 2-35 wash buffer flow sensor 4-13
PC printer setup 2-11
administration 2-37 process monitoring
power switch 6-15 disabling 4-10, 4-13
restart 6-17 event troubleshooting 5-16, 5-19, 5-30,
shut down 6-15 5-31
shut down using keyboard 6-16 wash pressure troubleshooting 5-22
shut down with no UI 6-16
shut down with UI 6-15

C95318-AA
processing tests assignment priority 1-10

priorities 1-15 automatic discard 2-17
system monitoring 1-11 database auto-delete 2-35
pumps event troubleshooting 5-28, 5-29, 5-30
event troubleshooting 5-25, 5-26, 5-41 expired discard 2-17
peristaltic status 4-36 remap diagnostics 4-8
vacuum status 4-36 removing obstructions 6-50
storage area 6-53
Q support procedures 6-50
QC troubleshooting slot positions 5-23
database auto-delete 2-35 usage 1-10
database auto-trim 2-35 reagent pipettors
troubleshooting events 5-26 assigned to calibrators 3-16
qualitative calibrations 1-19 assigning for tests 3-16
carryover testing 4-43
quantitative calibrations 1-19
disabling 2-17
enabling 2-17
R
event troubleshooting 5-23, 5-25, 5-31,
rack IDs 5-32, 5-40
adding 2-19 pressure sensor curves 4-28
attaching labels 2-24 priming 4-12
deleting 2-22
reagent storage
editing 2-19
clearing obstruction 6-50
setup 2-18
cover 6-51, 6-52
ranges event troubleshooting 5-32
clearing 3-22
reagent supplies
critical 3-19
deleting 3-22
reboot
LIS 3-19
see restart or shut down
onboard dilutions 3-19
reference 3-19 reference ranges 3-19
reports 3-23 reflex tests
setup 3-19, 3-21 adding 3-55
windows 3-20 changing conditions 3-57
reagent load door condition elements 3-45
event troubleshooting 5-28 condition keywords 3-46
manually unlocking 6-56 condition operators 3-46
condition syntax 3-46
reagent load tray
deleting 3-58
disabling 3-57
manually unlocking 6-57
editing 3-57
reagent pack gripper
enabling 3-57
event troubleshooting 5-28, 5-29
enabling or disabling all 3-60
examining 6-54
home position 6-54, 6-55
movement 6-54
overview 3-44
reagent packs replicates 3-57
assay technology 1-9 reserve volume 3-44, 3-51

C95318-AA
screen 3-49 restoring data

setup 3-44 assistance 2-46
setup reports 3-58 system backups 2-36
suppression 3-57 RVs
replacing cleanout 4-8
sample probe 6-36 specifications A-9
replacing a sample probe 6-36 troubleshooting missing 5-33, 5-36, 5-37,
5-40
reports
auto print setup 2-11
S
derived results setup 3-43
event log 5-10 safety
heading information 2-11 ground requirements A-4
ranges 3-24 material safety data sheets - Preface-2
reflex tests setup 3-59 procedure warnings - Preface-3
system check 4-21 Safety Data Sheets - Preface-2
system setup 2-11 sample aliquot station
test panels setup 3-34 rack obstruction 6-43
tests setup 3-18 sample IDs
rerunning tests bar code setup 2-28
automatic rerun troubleshooting 5-40 sample pick and place
QC troubleshooting 5-26 event troubleshooting 5-33
setting up reserve volume 3-44, 3-51 sample pipettor
reserve volume event troubleshooting 5-25, 5-33, 5-34
attaching rack labels 2-24 pressure sensor curve 4-28
designating racks 1-12 priming 4-12
determining the amount 3-51 sample probe
disabling 3-52 cleaning 6-30
enabling 3-52 redesigned 6-32
fixed 1-12 replacing 6-36
flexible 1-12, 2-21, 3-44, 3-51
sample processing
LAS setup 1-12
calibration verification 1-14
limits 3-51
dilution addition 1-16
processing theory 1-12
monitoring process 1-11
reflex tests 3-44
onboard dilution theory 1-13
reruns 3-44
order criteria 1-15
setting up 3-51
overview 1-14
setting up racks 2-18
reagent addition 1-16
standard 1-12, 2-21, 3-44, 3-51
reserve volume theory 1-12
unused 1-13
sample expiration 1-17
restart supply verification 1-14
after extended shut down 6-21 theory 1-11
cautions 6-20 washing and reading 1-16
initializing 6-21
sample racks
instrument only 6-20
attaching container type labels 2-23
PC 6-17
capacities A-11
PC power switch 6-17
label placement 2-22
user interface 6-17
label types 2-22

C95318-AA
loading position 6-40 shut down

out of position 6-41 for extended period 6-19
rack ID labels 2-24 instrument only 6-18
reserve volume labels 2-24 PC 6-15
setting up rack IDs 2-18 PC with no UI 6-16
setting up reserve volume 2-18 PC with UI 6-15
support procedures 6-38 software
troubleshooting backward 6-38 revision information 2-10
troubleshooting damaged 6-41 updating APF 3-4
troubleshooting events 5-15, 5-23, 5-26, space requirements A-2
5-27, 5-34, 5-35, 5-36
special dilution setup 3-16
troubleshooting obstruction 6-43
specifications
sample type setup 3-10
electrical A-4
sample wheel
environmental requirements A-2
sample bar code labels A-15
sandwich assays 1-7 space requirements A-2
screens temperature A-9
alignments 4-39 SPU
carryover 4-46 bar code reader defaults A-13
derived results 3-37 bar code reader properties A-13
event log 5-3 bar code reader setup 2-25
PC admin 2-37 cleaning 6-47
reflex tests 3-50 closing the lower panel 6-12
system check data 4-18 cover lock 6-12
system checks 4-16 event troubleshooting 5-34, 5-35, 5-36
system setup 2-7 hex bolt location 6-9
test panels 3-26 hex screw location 6-11
tests (setup) 3-6 holding pin location 6-10
search for (find) events 5-7 opening the lower panel 6-8
semi-quantitative calibrations 1-19 presentation tray drive belt 6-45
sensor calibrations rack sensors 6-48
bulk supply 1-24 routine button 6-38, 6-41
pressure 1-24 support procedures 6-38
sensors unlock SPU F8 6-41
calibrating pressures 4-28 substrate
calibrating wash buffer 4-30, 4-33 contaminants 6-25
calibrating waste 4-30, 4-33 contamination symptoms 6-25
cleaning SPU 6-47 decontamination 6-24
front offload (DxI 800 only) 6-49 drawback calibration 1-24, 4-10, 4-12
offload rack (DxI 800 only) 6-49 event troubleshooting 5-37, 5-38
process monitoring 1-11 priming 4-12
rack location 6-48 priming information 4-13
rack onload 6-48 supply bottle setup 2-16
viewing pressures 4-26 substrate checks
viewing temperatures 4-26 substrate ratio results 4-25

C95318-AA
substrate probe PC admin 2-37

drawback troubleshooting 5-38 report setup 2-11
subsystem restore with assistance 2-46
event troubleshooting 5-22, 5-38, 5-40 system setup 2-6
supplies setup system backups
bulk supplies 2-16 overview 2-36
expiration override 2-18 performing immediate 2-45
expired pack discard 2-17 replacing tapes 2-46
overview 2-14 restore with assistance 2-46
reagent pipettors 2-17 running scheduled 2-41
reserve volume racks 2-18 setting up 2-41
sample rack IDs 2-18 system checks
window 2-15 clean check results 4-25
supply capacities A-11 data screen 4-18
supply conditions diagnostics 4-15
overriding all expirations 2-18 displaying data 4-20
expected results 4-25
support procedures
report 4-20
fluidics 6-24
routines (flowchart) 4-24
general 6-3
running 4-22
rack and SPU 6-38
screen 4-16
reagent pack movement 6-50
solution handling warning 4-22
restart 6-14
substrate routine results 4-25
sample probe cleaning 6-30
substrate to washed ratio 4-25
sample probe replacing 6-36
unwashed routine results 4-25
shut down 6-14
washed routine results 4-25
substrate decontamination 6-24
upper main covers 6-4 system documentation
cautions - Preface-3
surge suppressors
warnings - Preface-3
instrument A-6
PC A-6 system ID change 2-9
recommendation A-6 system setup
system also see system administration
backups 2-36 bar code symbologies 2-25
initializing 4-6 customizing 2-6
process monitoring 1-11 date formats 2-10
setup 2-6 date setup 2-10
support procedures 6-3 language selection 2-9
LIS interface 2-31
system administration
LIS overview 2-30
LIS send mode 2-34
backups 2-36
overview 2-6
component revision information 2-10
screen 2-6
configure menu 2-3
SPU bar code reader 2-25
data management 2-35
supplies 2-14
managing database size 2-35
system ID change 2-9
overview 2-3
time formats 2-10
passwords 2-12
time setup 2-10

C95318-AA
test setup 3-9

T disabling tests 3-10
technical support - Preface-3 new assays 3-3
technology overview 3-5
assay 1-5 pipettor assignment 3-16
incubation 1-16 procedure 3-9
luminometer reading 1-16 range reports 3-23
sample processing 1-11, 1-14 ranges 3-19, 3-21
system overview 1-3 report 3-17
wash stations 1-16 result decimal places 3-10
temperature sample type 3-10
event troubleshooting 5-38 screen 3-5
heat production A-5 screen filter 3-8
requirements A-4 special dilution factor 3-16
specifications A-9 test IDs 3-9
viewing sensor information 4-26 units of measure 3-11
warm up time A-8 Tests
test configurations setting gray zones 3-13
also see test setup theory
APF 3-4 assay calibrations 1-18
derived results 3-35 confirmatory assays 1-23
overview 3-3 process monitoring 1-11
ranges 3-19 sample processing 1-11
reflex tests 3-44 time
test panels 3-25 format setup 2-10
test IDs system setup 2-10
test panel setup 3-30 troubleshooting
test setup 3-9 APF event 5-16
test panels assay calibration events 5-17
adding 3-28 bar code events 5-28
adding (flowchart) 3-31 bulk RV feeder events 5-16, 5-17
deleting 3-33 clean routine event 5-18
editing 3-32 device calibration events 5-33, 5-38, 5-40
filters 3-27 diagnostic procedures 4-3
naming 3-29 events 5-11
overview 3-25 events overview 5-13
screen 3-25 event-specific 5-15
setup 3-25 pick and place events 5-24, 5-25, 5-40
setup report 3-33 pressure sensor events 5-25, 5-33
test IDs 3-30 process monitoring events 5-16, 5-19,
5-30, 5-31
test requests
rack events 5-15, 5-23, 5-26, 5-27, 5-34,
confirmatory assays 1-23
5-35, 5-36
priorities 1-15
reagent pack events 5-28, 5-29, 5-30
test results reagent pack gripper events 5-28, 5-29
QC event troubleshooting 5-26 reagent pipettor events 5-23, 5-31, 5-32,
reporting configuration 3-3 5-40
units by sample type 3-11 reagent storage events 5-32

C95318-AA
sample pick and place events 5-33 windows

sample pipettor events 5-33, 5-34 add derived result 3-39
SPU events 5-34, 5-35, 5-36 add panel 3-29
substrate events 5-37, 5-38 add reflex condition 3-55
support procedures 6-3 add/edit racks 2-20
wash buffer events 5-40, 5-41 analog devices 4-27
U bar code reader setup 2-28
ultrasonics decontaminate substrate 6-27
calibration 1-24 decontaminate substrate, bottle options
6-29
details (event log) 5-12
units (of measure) setup
edit units (test setup) 3-12
editing 3-11
filter (event log) 5-6
filter (test panels) 3-27
UPS
filter (tests) 3-8
instrument backup power A-6
find (event log) 5-7
PC backup power A-6
gray zone 3-14
recommendations A-6
initialize system 4-7
user interface (UI) LAS draw reserve volume 3-54
shut down PC 6-15 LIS setup 2-31
monitoring statistics (priming) 4-14
V peristaltic and vacuum pumps 4-36
vacuum failure pressure sensor calibration 4-28
sample wash tower 5-37 prime fluidics 4-11
wash collar 5-42 print (event log) 5-9
voltage information rack ID 2-19
power supply 4-26 ranges 3-21
sensor calibration 4-30, 4-33 reports setup 2-11
reserve volume setup 3-53
W scheduled backup 2-42
warning events 5-5 supplies setup 2-15
without troubleshooting 5-13 wash buffer sensor calibration 4-31, 4-33
warnings
description - Preface-3
wash buffer
priming bubble detector 4-13
priming the flow sensor 4-13
sensor calibration 4-30, 4-33
supply container setup 2-16
warning 4-22
wash carousel
weights
instrument A-3
peripheral devices A-3

C95318-AA

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Reference Manual

Changes to this Revision

This manual is intended for use with:

May be covered by one or more patents - see www.beckmancoulter.com.

1 System Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

2 System Administration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

3 Configuring Tests and Results . . . . . . . . . . . . . . . . . . . . . . . 3-1

© 2022 Beckman Coulter, Inc. i

5 Event Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

6 System Support Procedures . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

A System Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

ii © 2022 Beckman Coulter, Inc.

UniCel DxI System Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface-2

Notes, Cautions, and Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface-3

Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface-3

© 2022 Beckman Coulter, Inc. Preface-1

UniCel The UniCel DxI system includes the following documentation.

Preface-2 © 2022 Beckman Coulter, Inc.

Notes highlight or provide additional information.

Cautions emphasize the possibility of damage to the

Warnings emphasize the possibility of harm to a

Table 1 Notes, Cautions, and Warnings

© 2022 Beckman Coulter, Inc. Preface-3

Preface-4 © 2022 Beckman Coulter, Inc.

LIS Interface ..................................................................................................... 1-4

Integrated Workstations .................................................................................... 1-4

LAS Interface .................................................................................................... 1-4

1.2 Assay Technology ......................................................................................... 1-5

Paramagnetic Particles ...................................................................................... 1-6

Chemiluminescence .......................................................................................... 1-6

Competitive Binding Assays............................................................................. 1-6

Sandwich Assays............................................................................................... 1-7

Antibody Detection Assays............................................................................... 1-8

Reagent Packs ................................................................................................... 1-9

Assay Characteristics ...................................................................................... 1-10

1.3 Sample Processing Theory ......................................................................... 1-11

Process Monitoring ......................................................................................... 1-11

Reserve Volume .............................................................................................. 1-12

Onboard Dilutions........................................................................................... 1-13

Test Requests and Sample Processing ............................................................ 1-14

Supply and Calibration Verification ............................................................... 1-14

Sample Processing Order ................................................................................1-15

Reagent Addition ............................................................................................ 1-16

Sample Washing and Reading ........................................................................ 1-16

© 2022 Beckman Coulter, Inc. 1-1

Sample Expiration........................................................................................... 1-17

1.4 Assay Calibration Theory ........................................................................... 1-18

Assay Calibration Types ................................................................................. 1-19

Quantitative and Semi-Quantitative Calibration............................................. 1-20

Qualitative Calibration .................................................................................... 1-22

1.5 Confirmatory Assay Theory ....................................................................... 1-23

1.6 Device Calibration ...................................................................................... 1-24

1-2 © 2022 Beckman Coulter, Inc.

1.1 System Technology Overview

Access Immunoassay System assays are heterogeneous, enzyme-mediated assays.

To optimize laboratory efficiency, the system provides continuous random access

© 2022 Beckman Coulter, Inc. 1-3

1-4 © 2022 Beckman Coulter, Inc.

1.2 Assay Technology

Immunoassays use a variety of assay formats to measure or detect analyte in samples.

In general, assay formats use reagents that include:

In the detection phase, a chemiluminescent substrate is added to the paramagnetic

© 2022 Beckman Coulter, Inc. 1-5