DX IIFU

Instructions for Use
For In Vitro Diagnostic Use
EC REP
Beckman Coulter Ireland, Inc.
Lismeehan, O’Callaghan’s Mills,
Co. Clare, Ireland
Tel: +(353) (0) 65 683 1100
C96782-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, C96782-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:
C94099-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
C85243-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
C73201-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
C48059-AA, August 2020 UniCel DxI software versions 5.1, 5.2, 5.3.0, 5.3.1, 5.5.0, and 5.6.0
C38266-AB, March 2019 UniCel DxI software versions 5.1, 5.2, 5.3.0, 5.3.1, and 5.5.0
C38266, 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.
Monovette is a trademark of Sarstedt A.G. & Co.
Contrad is a trademark of Decon Laboratories, Inc.
Citranox is a trademark of Alconox, Inc.
Quidel is a trademark of Quidel Corporation.
Triage is a trademark of Quidel Corporation.
Bio-Rad is a registered trademark of Bio-Rad Laboratories, Inc.
All other trademarks are the property of their respective owners.
UniCel DxI Instructions for Use Table of Contents
Table of Contents
1 System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
• Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
• Scope of Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
• Reference Materials. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
• Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
• System Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
• Status Indicator Lights. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
• System Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
• System Status Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5
• Help Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
• System Command Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
• Main Menu Workflow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
• Precautions and Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
• Regulatory Symbols and Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
• Other Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
• System Specifications and Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
• Electrical Requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
• Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
• Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17
2 Shut Down and Restart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

• Shutting Down the PC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
• Restarting the PC and UI Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
• Shutting Down the Instrument. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
• Shutting Down the System for an Extended Period . . . . . . . . . . . . . . . . . . . . . . . . 2-6
• Restarting the Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
• Restarting the System After an Extended Shut Down. . . . . . . . . . . . . . . . . . . . . . . 2-8
3 Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
• System Status Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
• Changing an Empty or Expired Substrate Bottle . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
• Changing an Empty Bulk Wash Buffer Container . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
• Adding RVs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
• Changing a Full Bulk Liquid Waste Container . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
• Changing a Full Solid Waste Container . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
• Loading a Reagent Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
• Unloading a Reagent Pack. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
© 2022 Beckman Coulter, Inc. i

C96782-AA
UniCel DxI Instructions for Use Table of Contents
4 Racks and Sample Containers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

• Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
• Calculating Minimum Sample Volume. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
• Sample Containers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
5 Sample Manager . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

• Downloading LIS Test Requests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
• Querying the LIS for Test Requests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
• Manual Test Requests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
• Calibration Test Requests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
• Quality Control Test Requests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
6 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
• Maintenance Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
• Daily Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
• Special Weekly Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
• Test Interval Maintenance: 5,000 Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
• Test Interval Maintenance: 10,000 Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
• Maintenance Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-15
7 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
• Event Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
• Troubleshooting Events. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
• QC Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
• Test Result Flags and Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
8 Theory of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

• Sample Processing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
• Device Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
• Assay Characteristics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
• Assay Calibration Theory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
A Temperature-Sensitive Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
B Ordering Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1

• Assay-Specific Reagents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-1
• System Supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-8
• UniCel DxI System Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-10
© 2022 Beckman Coulter, Inc. ii

C96782-AA
UniCel DxI Instructions for Use 1: System Overview
1 System Overview
Intended Use
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.
FOR PROFESSIONAL USE ONLY
Scope of Manual
The UniCel DxI Instructions for Use manual is designed for use after you have become familiar with the
UniCel DxI system. This manual contains short instructions for everyday use and routine maintenance. It also
contains general information about the UniCel DxI system, such as theory of operation, system specifications,
safety labeling, and troubleshooting.
Reference Materials
Additional UniCel DxI system documentation is listed in Appendix B. For more information, contact your
Beckman Coulter representative.
Technical Support
For technical assistance with the UniCel DxI Access Immunoassay System:
• 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.
Be prepared to provide your system ID.
© 2022 Beckman Coulter, Inc. 1-1

C96782-AA
System Description
The UniCel DxI system consists of two major subsystems: the instrument, which performs all sample
processing functions, and the system console, which provides the human interface. There are several points of
operator interaction:
21 7
1
20 8
2
3
9 10
19
11
4
18 5
12
6
13
14
15
17 16
UniCel DxI 800 System
2055A.eps
1 Touchscreen monitor 2 Keyboard 3 Mouse

4 PC bar code reader 5 Printer 6 External Computer
7 Right main upper cover 8 Status indicator lights 9 Substrate load area
10 Reagent load/unload 11 System status panel 12 STAT/Routine buttons
area (if equipped)
13 Substrate bar code 14 Main power switch (behind 15 Wash buffer supply drawer
reader door)
16 Solid waste door 17 Liquid waste drawer (optional) 18 Sample presentation unit
(SPU)
19 Side offload area 20 Vessel hopper door 21 Left main upper cover

C96782-AA
19 7
1
18 8
2
3
9 10
4
17 5
11
6
12
13
14
16 15
UUniCel DxI 600 System
2055B.eps
1 Touchscreen monitor 2 Keyboard 3 Mouse

4 PC bar code reader 5 Printer 6 External Computer
7 Right main upper cover 8 Status indicator lights 9 Substrate load area (hidden in
picture)
10 Reagent load/unload 11 STAT/Routine buttons 12 Substrate bar code reader
area
13 Main power switch 14 Wash buffer supply drawer 15 Solid waste door
(behind door)
16 Liquid waste drawer 17 Sample presentation unit (SPU) 18 Vessel hopper door
(optional)
19 Left main upper cover

C96782-AA
Status Indicator Lights

The four status indicator lights are arranged vertically on the front panel of the instrument. The Red, Green, and
Blue indicator lights designate a specific instrument operating mode. The Amber indicator light informs you
when a supply level requires your attention.
2091A.bmp
1 Red: Not ready. Indicates either that the system has stopped, or that initialization is in progress.
2 Amber, steady: Supplies required. One or more system supply areas are low, or waste containers
are almost full. The system will continue to process samples and schedule new tests.
Amber, blinking: Supplies required. One or more system supplies are out, or an area requires
attention. The system will not schedule new tests, but will complete tests in progress.
3 Green: Running. System is processing tests or performing a maintenance routine.
4 Blue: Ready. No processing operations are in progress, but the system is ready to begin processing.
SPU operations such as aliquoting of samples can take place while in the Ready mode.
System Modes
The UniCel DxI system operates in one of four system modes. The current mode is displayed in the upper left
corner of each screen. When the system is in the Running mode, the estimated completion time for the
scheduled tests is displayed as a text line above the three system command buttons.
System Mode Description
Ready The system is ready to begin processing samples. SPU operations such as aliquoting
of samples can take place while in the Ready mode.
Running The system is performing a function, such as processing samples or running a

maintenance routine.
Paused No new tests are scheduled, but currently scheduled tests continue processing.
Not Ready The system is not ready to process samples. The system requires initialization, or it is
checking the status of subsystems, initializing motors, or homing movable parts.

C96782-AA
System Status Buttons

There are six system status buttons. Under normal operating conditions the button colors are neutral. Select a
button to view its related screen.
The buttons change color to inform you when a supply level requires your attention, a sample processing issue
exists, or the Event Log is reporting a caution or a warning. A button stays red or yellow until you select it to
review the alert condition.
System Status Button Description Button Colors
Rack Exceptions Select to display the Exceptions Yellow

view of the Sample Manager One or more sample containers has an
screen. error associated with it.
Work Pending Select to display the Work Pending Yellow

screen for information about test A test request cannot be processed
requests that the system cannot because a sample is required.
schedule.
Supplies Required Select to display the Supplies Yellow

Required screen for information The system requires supplies or
about needed supplies or calibration to complete the requested
calibrations. tests.
Red
The system cannot start tests until the

underlying instrument condition has
been resolved. Certain conditions
provide a Help button in the Status
column that link directly to the
corresponding Help procedure topic for
rectifying the condition.
NOTE
The icon color reflects the
condition currently displayed on the
screen with the highest concern
level. If there is at least one
instrument condition that meets a
red icon state, that condition takes
precedence and the Supplies
Required icon displays red.

C96782-AA
System Status Button Description Button Colors
Bulk Supplies Select to display the Bulk Supplies Yellow

screen for information on the A supply is low or near expiration, or a
available quantities of substrate, waste container is nearly full. The
wash buffer, and RVs, and the needle on the gauge is displayed near
available space in the solid waste the left end of the scale.
container and in the bulk liquid
waste container. Red
A supply is empty or expired, or a waste

container is full. The needle on the
gauge is displayed all the way to the
left.
Quality Control Select to display the Quality Red
Control screen to set up quality A quality control result is not within the
controls or to review quality acceptable range of expected values.
control results.
Event Log Select to display the Event Log Yellow

screen for information about events The system has generated a caution
generated by the system. From this event indicating a condition that
screen you can display requires your attention soon.
troubleshooting information about
caution or warning events. Red
The system has generated a warning

event, indicating that a serious fault or
error condition exists.
Help Button
Select the Help button to display a topic with information about the screen you are on, a View Screen link to a
picture with descriptions of the screen, and a list of related topics. From the screen topic, you can navigate to
anywhere in the Help system.
The Help button also provides links to procedures for critical instrument conditions displayed on the Supplies
Required screen.

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System Command Buttons

You use the three system command buttons to stop, pause, or resume processing.
Button Screen
Description
Display
Stop Select to stop the instrument. The system stops processing and cancels any tests in
progress. The system requires initialization before tests can be run again.
Pause Select to pause the instrument. The system stops aliquoting after it finishes the
current aliquot. No new tests are scheduled. Processing continues on samples
already in progress.
Resume Select to resume processing when the system is in the Paused mode.
Main Menu Workflow

Select one of the Main Menu function buttons to display an associated screen or menu. Across the bottom of a
new screen is another row of function buttons. Select one of these buttons to perform an action or to display a
menu with additional function buttons.
The following flowchart outlines the workflow for each of the Main Menu function buttons.

C96782-AA
Main Menu Workflow
F1 In Progress
F1 Views F2 Requested F1 Rack ID
F3 Daily F2 Delete Sample
F4 Exceptions F3 New Request
F4 Test Results
F5 Request QC
F2 Edit Request (Requested and Daily views) F6 Cancel Request
Clear Exceptions (Exceptions view) F7 Clear All Samples
Sample Manager F8 More Options
F1 F1 Patient/QC Requests
F3 New Request F2 Calibration
F1 Rack ID
F3 Maintenance
F3 New Request
F4 Test Results (N/A for
F4 Test Results F1 Filter maintenance requests)
F5 Work Pending F2 Sample Manager F6 Cancel Request
F6 Find F6 Delete
F8 Details F7 Print
F8 Options
F1 Filter
F2 Find
F3 Rerun Test
F4 Sample Details
F5 Send to LIS
Test Results
F6 Copy to Disk F1 Report
F2
F7 Print F2 Completed Samples
F1 Refresh Screen
F8 More Options F2 Configure Screen
F3 Delete Data
F1 Reagent Supplies F1 Substrate

F1 Bulk Supplies F3 Change In-Use Bottle F2 Liquid Waste
F3 Wash Buffer
F8 Reagent Inventory
Supplies
F3
F1 Reagent Supplies
F1 Bulk Supplies
F2 Unload Reagent Pack
F2 Unload Reagent Packs
F5 Delete Pack
F3 Unload All Reagent Packs
F7 Print
F6 Details
F2 Reagent Supplies F8 Filter
F7 Print
F8 Reagent Inventory
F1 Filter F1 Filter
F2 Review Chart F5 Delete Point
and Data F6 Copy to Disk
F7 Print
Quality Control
F4 F3 Compare Charts F1 Save Comparison F1 Chart 1
F4 Delete Comparison F2 Review Chart and Data F2 Chart 2
F4 Edit Date Range F3 Chart 3
F5 QC Setup F1 Add Control

F7 Print F2 Edit Control
F6 Delete Control
F1 Filter F1 Active
F2 Review Data F1 Select Curve/Limits F2 Previous Active
F2 Switch Active Curve F3 Last Run
F3 Comment
Calibration F7 Print
F5
F5 Calibrator Setup F1 Add Calibrator

F6 Delete F2 Edit Calibrator
F7 Print F6 Delete Calibrator
3003C.wmf

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Main Menu Workflow, continued
F1 Pipettor Matching F1 Reag. Pipettor Matching

F2 System Checks F2 Low Volume Matching
F3 Carryover
F4 Decontaminate
Maintenance Review
Substrate
F6
F5 Run Utility Routine
F6 Enable/Disable
Utility Routine
F7 Print
F1 RV Feeder
F1 Initialize System F2 RV Mixer
F2 Prime Fluidics F3 Pick and Places
F3 Subsystem F4 Reagent Storage
Diagnostics F5 Volume Checks
F1 Home All
F1 Mechanics F2 Alignments
F1 Pressure
F2 Wash Buffer
F2 Analog Devices F1 Analog Data F3 Liquid Waste
F2 Sensor Calibration F4 Wash Buffer Flow
F4 Device Diagnostics
F3 Digital Devices F1 Panel Lights
F2 Peristaltic and
F1 Read
Diagnostics
Vacuum Pumps
F2 Load/Read Vessel
F7 F3 Digital Inputs
F3 Save LED Reading
F4 Digital Outputs
F4 Luminometer F4 Save High Voltage
Control
F5 Dark Count Check
F8 Cancel
F1 Ultrasonic Settings
F5 Ultrasonics F2 Ultrasonics Adjustments F1 SPU
F6 Exerciser
F2 LAS
F7 RF Level Sense
F1 LIS F1 LIS Setup

F5 LIS/LAS
F2 LAS F3 Loopback Check
F6 Save Data F1 Copy to Disk F4 Query for
F7 Diagnostic Reports F2 Export Logs Test Requests
F8 Unlock SPU
F6 Copy to Disk
F8 Clear Screen
F1 System Setup F1 System Revisions

F2 Bar Code
F1 Filter Reader Setup
F2 Edit Units F3 Set Workgroup
F3 Ranges Date/Time
F2 Tests F4 Gray Zone F5 Password Setup
F5 Special F6 Supplies Setup
F6 Assign Pipettor F7 Reports Setup
F7 Print F8 Rack ID Setup
F8 Update APF
F3 Test Panels F1 Filter

Configure
F4 Add Panel
F8
F3 Ranges F5 Edit Panel
F4 Add Derived F6 Delete Panel
Result F7 Print
F4 Derived Results F5 Edit Derived
Result
F6 Delete F2 Rack ID Setup
F1 DxI Reserve
F7 Print F3 Reserve Volume Setup
F2 LAS Reserve
F4 Add Reflex Test
F5 Reflex Tests F5 Edit Reflex Test
F6 LIS/LAS F1 Scheduled Backup F6 Delete
F7 PC Admin F2 Immediate Backup F7 Print
F8 About DxI 800 F1 Enable All
F3 Eject Tape F8 More Options
or DxI 600 F2 Disable All
F4 Restore
F5 Auto-Delete Setup F1 Shut Down PC
F6 Reset Verbosity F2 Shut Down Instrument
F7 Database Maintenance F3 Instrument Service
F8 System Admin F4 Remote Management
F5 Integrated System Setup
3004J.wmf

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Precautions and Hazards

Safety Features
The UniCel DxI Access Immunoassay System is designed to meet U.S. and international safety standards.
Safety labels are affixed to the instrument to alert you to safety considerations. Interlock switches stop the
movement of the pipettors and robotic modules to protect you from injury if you open the instrument covers
while the system is running.
Interlock Switches
The UniCel DxI system is equipped with interlock switches to protect you from injury. If you open the covers
of the instrument, the interlock switches stop all moving parts. If you open the covers while the system is
processing samples, the system cancels all tests in progress.
Safety Symbols
Certain areas of the UniCel DxI instrument present a risk of personal injury or damage to the instrument if
proper safety procedures are not followed. These areas are marked with one or more safety symbols to identify
the hazard. These symbols are defined in the Access Immunoassay Systems Symbol Glossary, available at
techdocs.BeckmanCoulter.com.
Laser Symbol
The laser symbol indicates areas of the instrument where laser light is used. Do not
stare into the laser beam.
Laser Warning Labels

The UniCel DxI system uses lasers that read and process bar code information. Under certain conditions laser
light can cause eye injuries. As a safety measure, the locations of lasers on the UniCel DxI system are marked
with warning labels. The lasers are located and shielded beneath housings that protect operators from accidental
exposure to the laser beam.
The UniCel DxI laser products conform with the provisions outlined in Code of Federal Regulations Title 21
(subchapter J, section 1040.12), and with IEC 60825-1.
CAUTION
Do not remove the laser warning labels or the protective housings that shield the lasers. The lasers
are accessible if the protective housings are removed. Only a trained Beckman Coulter technical
support representative should service the lasers. Do not stare directly into a laser beam if the
instrument cover is opened or removed.
Laser Warning Label Location
LASER LIGHT IS EMITTED

This label is attached to the sample presentation unit (SPU) bar code
AVOID EXPOSURE
reader and the reagent storage bar code reader.
FROM THIS APERTURE
CAUTION
VORSICHT
11-110008-01
LASER RADIATION
LASERSTRAHLUNG, NICHT IN DEN
DO NOT STARE INTO BEAM LICHTSTRAHL BLICKEN. SICHTBARE
CLASS 2 LASER PRODUCT LASERSTRAHLUNG.
670nm 1.0mW 101~186µs
LASERKLASSE 2
IEC 60825-1 Ed. 2 (2007)
CAUTION - CLASS 2 LASER RADIATION WHEN OPEN-DO NOT STARE INTO THE BEAM.
PRODUCT COMPLIES WITH 21 CFR 1040.10 AND 1040.11 EXCEPT FOR DEVIATIONS
PURSUANT TO LASER NOTICE NO. 50, DATED JUNE 24, 2007

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Laser Warning Label Location
These labels are attached to the housing that shields the reagent
storage bar code reader.
&
These labels are attached to the back of the UniCel DxI instrument.
CLASS 1 LASER PRODUCT
PRODUCT COMPLIES WITH

21 CFR CHAPTER 1, SUBCHAPTER J
Beckman Coulter, Inc. MADE IN U.S.A. MARCA REG

%
Safety Statements
The following statements describe general safety concerns and provide information about attention symbols
with no accompanying text.
WARNINGS
• The UniCel DxI instrument has moving parts and uses high voltage in the ultrasonic transducers.
Both present an injury hazard. Do not operate the UniCel DxI instrument with the covers or
doors open.
• 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).
• Always plug the UniCel DxI system into a grounded three-conductor outlet. DO NOT bypass the
grounding prong on the plug.
• Do not defeat the safety interlock switches on the covers.
CAUTION
Replace substrate bottles only with the main upper covers closed to avoid spillage into the
instrument.

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Regulatory Symbols and Statements

The UniCel DxIAccess Immunoassay System meets the requirements of a variety of domestic and international
regulatory agencies, standards, and directives. This compliance is indicated by symbols and marks on the
instrument,. These symbols are defined in the Access Immunoassay Systems Symbol Glossary, available at
techdocs.BeckmanCoulter.com.
Notice to User
For a patient/user/third party in the European Union and in countries with identical regulatory regime
(Regulation 2017/746/EU or In vitro Diagnostic Medical Devices): if, during the use of this device or as a result
of its use, a serious incident has occurred, please report it to the manufacturer and/or its authorized
representative and to your national authority.
Radio Frequency Emissions Statement

This IVD equipment complies with the emission and immunity requirements described in IEC 61326-2-6.
The UniCel DxI system has been tested and shown to be compliant with the requirements of CISPR 11 and part
15 of FCC rules for a Class A digital device. These requirements are intended to provide reasonable protection
from interference when the instrument is operated in a commercial environment.
CAUTIONS
• This equipment has been designed and tested to CISPR 11 Class A. In a domestic environment it
could cause radio interference, in which case you may need to take measures to mitigate the
interference.
• Prior to operation of this device, the electromagnetic environment should be evaluated. Do not
use this device in close proximity to sources of strong electromagnetic radiation (for example,
unshielded intentional RF sources) as these could interfere with proper operation.
• If you suspect interference between the UniCel DxI system and other equipment, you must take
whatever action is required to correct the interference. Beckman Coulter suggests the following
actions:
- Move the equipment so there is a greater distance between the equipment and the
UniCel DxI system.
- Re-orient the equipment with respect to the UniCel DxIsystem.
- Be sure that the equipment is operating from a different power service connector than that of
the UniCel DxI system.
LED Safety Statement

The handheld bar code reader has been tested in accordance with EN60825-1 LED safety, and has been certified
to be under the limits of a Class 1 LED device.

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Other Symbols
In addition to safety and regulatory symbols, other symbols are placed on the instrument to identify functional
elements such as network jacks and the air filter. These symbols are defined in the Access Immunoassay
Systems Symbol Glossary, available at techdocs.BeckmanCoulter.com.
System Specifications and Characteristics

Space Requirements
The dimensions of the instrument and the peripheral devices are listed in the following table. Be sure that the
area designated for these components is large enough to accommodate the system.
UniCel DxI 800 System UniCel DxI 600 System
Instrument: Covers and Width = 67.5 inches (171 cm) Width = 61.5 inches (156 cm)
Drawers Closed Height = 67 inches (170 cm) Height = 67 inches (170 cm)
Depth = 37.5 inches (97 cm) Depth = 37.5 inches (97 cm)
Instrument: Covers and Width = 67.5 inches (171 cm) Width = 61.5 inches (156 cm)
Drawers Opened Height = 75.2 inches (191 cm) Height = 75.2 inches (191 cm)
Instrument Clearance Rear = 11.8 inches (30 cm) Rear = 11.8 inches (30 cm)
Required for Ventilation Top = 8.5 inches (22 cm) Top = 8.5 inches (22 cm)
Instrument Clearance Front = 15.5 inches (39 cm) Front = 15.5 inches (39 cm)
Required for Opening Rear = 14.5 inches (37 cm) Rear = 14.5 inches (37 cm)
Covers and Drawers
Top = 8.5 inches (22 cm) Top = 8.5 inches (22 cm)
Service Clearance Required Front = 38.5 inches (98 cm) Front = 36.5 inches (93 cm)
for Opening SPU
System Console (Cart with Width = 29.8 inches (76 cm) Width = 29.8 inches (76 cm)
External Computer and Height = 67.5 inches (171 cm) Height = 67.5 inches (171 cm)
Peripherals)
Instrument and Peripheral Device Weights

The weight of the instrument and the peripheral devices are listed in the following table. Be sure that the surface
where these components will reside can support the system.
UniCel DxI 800 Instrument (before supplies 1390 pounds (630 kg)
and samples are added)

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UniCel DxI 600 Instrument (before supplies 1065 pounds (483.1 kg)
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
Operating Environment Requirements

The UniCel DxI system is for indoor use only and requires the following environmental conditions to operate
properly:
Humidity, RH (Non-condensing) Operational: 20-85%

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 Temperature Change 3.6°F per 30 minutes (2°C)
Rate During Operation
Ambient Light Results not affected by ambient light levels between
0-200 foot-candles
Pollution Degrees 2
* Some assays require additional temperature restrictions. See Appendix A of this 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 Requirements
The UniCel DxI system uses two separate power supplies: one for the instrument, and 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 (UniCel DxI instrument is the only
equipment connected to the electrical line)

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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.
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 Voltage 180 VAC
Maximum Tested Operating Voltage 264 VAC
Maximum Voltage Between Neutral Not to exceed 2 VAC root mean square (RMS)
Conductor and Safety Ground Conductor
Maximum Resistance Between the Safety Not to exceed 0.1 ohm
Ground Conductor and an Accessible
Building Safety Ground
Transient Overvoltages According to UL3101 Installation Category II
Electrical Line: External Computer
Line Power Supply 110-120 VAC at 6 amps, 50/60 Hz, or 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 British Thermal Units (BTU)/hour

External See documentation provided by the See documentation provided by the
Computer manufacturer manufacturer
LCD Monitor See documentation provided by the See documentation provided by the
manufacturer manufacturer
Laser Printer See documentation provided by the See documentation provided by the
manufacturer manufacturer
Surge Suppressors
Beckman Coulter recommends that you do not use a surge suppressor with the UniCel DxIinstrument. The
instrument has built-in protection similar to that provided by a surge suppressor.

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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.
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)
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 port located on 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 Help topic LIS Setup or the
LIS Vendor Information document.

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Integrated Workstations
The UniCel DxI system can be integrated with the UniCel DxC (chemistry) system 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.
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), 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. The track can route samples to multiple instruments in the laboratory.
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, contact your Beckman Coulter
representative.
Installation
The UniCel DxI Access Immunoassay System must be installed by a qualified Beckman Coulter technical
support representative. Do not remove the instrument from the shipping crate until a technical support
representative is present.
Warranty
The UniCel DxI Access Immunoassay System is covered by and subject to the provisions of the warranty
included in your contractual agreement for the system or its reagents.
The customer is responsible for routine preventive maintenance procedures. Repairs arising from the failure to
perform these maintenance procedures at the indicated time intervals will be made at the discretion of
Beckman Coulter, and at the customer’s expense.

C96782-AA
UniCel DxI Instructions for Use 2: Shut Down and Restart
2 Shut Down and Restart

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.
Shutting Down the PC

There are two methods for shutting down 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.
NOTE
If you are shutting down the PC and the instrument at the same time, shut down the instrument first.

C96782-AA
Shutting Down the PC with the UI Software

Use this procedure to shut down the PC with the UI software.
System Mode: Ready Not Ready
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.
• 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. Wait at
least 20 seconds before restarting the PC.
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
• 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.
• Only use the computer keyboard to shut down the UI if you have no other 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. Then wait at least 20
seconds before restarting the PC.
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 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.

C96782-AA
2379A.bmp
Windows® XPe Windows® 8e
1. Simultaneously press the [Ctrl], [Alt], and 1. If necessary, press the Windows® key [®] on
[Delete] keys on the computer keyboard. the keyboard to display the Start screen.
2. Select Shut Down. 2. Move the mouse cursor to the lower-right corner
3. 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.
4. Select OK. 3. Select the Settings icon.
2380A.bmp
The Settings panel is displayed.
4. Select the Power icon.
5. Select Shut down or Restart, depending upon

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

down anyway or Restart anyway near the
bottom of the screen, select the button.

C96782-AA
Restarting the PC and UI Software

Use this procedure to restart the PC and the 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 and press and hold the switch for 2 seconds to turn
the power on and start the UI software.
 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.
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.
NOTE
To be sure that all test results are sent, display the Test Results screen and filter the results by completion
time. 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.

C96782-AA
Shutting Down the Instrument

In some circumstances, it may be necessary to shut down the instrument and not the PC. Shut down the
instrument only if instructed to do so by a technical support representative or by the system documentation.
NOTES
• You need the system password to use this feature. If you do not know the password, contact your lab
supervisor.
• 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 area.

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.
3. Enter the system password, then select OK F1.
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.
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.

C96782-AA
Shutting Down the System for an Extended Period

If you plan to have the instrument moved, or if power to the system will be turned off for an extended period of
time (more than five days), shut down the entire UniCel DxI system. Before moving or shutting down the
system, contact Technical Support to confirm your strategy.
WARNINGS
• You will come in contact with potentially infectious materials during these procedures. Handle
and dispose of biohazard materials according to proper laboratory procedures. Proper hand,
eye, and facial protection is required.
• 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
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.
2. Remove all racks and sample containers from the onboard and offboard areas of the sample presentation
unit (SPU).
3. Unload and refrigerate all of the reagent packs.
4. Change the bulk liquid waste containers if your system uses them.
5. Change the solid waste container.
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.
7. Remove and refrigerate the bottles equilibrating in the substrate equilibration area.
8. Shut down the PC and the instrument. This includes shutting off the power switch for the instrument and
the PC.

C96782-AA
Restarting the Instrument

Use this procedure to restart the UniCel DxI instrument if the power to the 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.
4. Press the top part of the switch to turn the power on ( | position) and then wait 90 seconds.
5. Press and hold the console PC power switch for two seconds to turn power on and start the UI software.
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.
9. Continue normal operation.

C96782-AA
Restarting the System After an Extended Shut Down

Use this procedure to restart the UniCel DxI system following an extended shut down.
WARNINGS
• 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.
• 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.

1. Restart the PC and the UI software.
2. Restart the instrument.
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.
4. Empty the solid waste container if it is full. If your system uses bulk liquid waste containers, empty them if
they are full. Check the RV supply. If necessary, add more RVs.
5. Load new substrate bottles.
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.
6. From the Diagnostics menu, select Prime Fluidics F2 to display the Prime Fluidics window.
7. Select All F3. All of the components are selected for priming.
8. 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 #1 to #4 - Enter 4 cycles in each box.
9. Select Start Priming F2. When the priming is complete, a message is displayed.
10. Select OK F1 to exit the message window.
11. Select Done F1 to exit the Prime Fluidics window.

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12. Depending upon how long the system has been shut down, perform the following procedures.
> 2 Weeks 1-2 Weeks < 1 Week
10,000 Test
X
Interval Maintenance
Special Clean Routine X X X
All System Check Routines X X
Run QC X X X

C96782-AA
UniCel DxI Instructions for Use 3: Supplies
3 Supplies
System Status Panel
(UniCel DxI 800 System Only; not all systems are equipped)
Some UniCel DxI 800 instruments have a system status panel located directly below the status indicator lights.
The panel has six icons that correspond to specific supply areas. A panel icon is lit if a supply is low,
approaches its expiration date, or a waste container is almost full. The icon blinks if a supply runs out, expires,
or if a waste container is full.
The Console panel icon is lit if one or more of the following system status buttons turns yellow or red:
• Rack Exceptions
• Work Pending
• Supplies Required
• Quality Control
• Event Log
The Console panel icon blinks if the Event Log button turns red.
2033A.bmp
1 RVs icon
2 Substrate icons
3 Console icon
4 Wash Buffer icons
5 Solid Waste icon
6 Liquid Waste icons

C96782-AA
Changing an Empty or Expired Substrate Bottle

Check the substrate status to determine how many bottles to change. When all of the on-board substrate bottles
are empty or expired, the system completes any in progress tests, but does not schedule any new tests until you
change at least one bottle.
System Mode: Any Mode
UniCel DxI System with

UniCel DxI 600 or 800 System
System Status Panel
Check the Bulk Supplies screen for
Check the Substrate panel icons for
container status
container status
Open the substrate load door

and release the load tray
UniCel DxI system with UniCel DxI 600 or 800 System
System Status Panel
Consult the Bulk Supplies screen to
If equipped, check the Substrate determine whether a lot is near
Remove the empty or
panel icons to determine how many expired bottle and discard expiration or if a bottle is empty.
bottles to change.
Blinking: Change all empty or
expired bottles.
Remove a new bottle from
the substrate equilibration
Solid: Consult the Bulk Supplies area
screen to determine whether a lot is
near expiration or if a bottle is
empty. Remove the cap from the
new bottle and place the
bottle in the load tray with
the bar code facing out
Push in the load tray until it

locks in place and the
system closes the door
Scan the bar code label
Place an unequilibrated
bottle in the substrate
equilibration area
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Changing an Empty Bulk Wash Buffer Container

Check the wash buffer status to determine how many containers to change. When all of the on-board containers
are empty, the system completes any in progress tests, but does not schedule any new tests until you change at
least one container.

System Status Panel
Check the Wash Buffer panel icons
container status
for container status
CAUTION WARNING
Pull out the wash buffer
To avoid contaminating supply drawer Wash buffer contains a
the wash buffer supply, preservative which may
do not touch any tubes cause sensitization by skin
Remove the perforated
that enter the container. panels from a new container contact. After contact with
and gently mix the container
Handle the assembly by skin, wash immediately
the cap only. with soap and water. Wear
Extend the neck of the new suitable gloves.
container and remove the
cap and inner seal
Is there a
UniCel DxI system with disconnect on the No UniCel DxI 600 or 800
cap and tube System
System Status Panel assembly?
Consult the Bulk Supplies
If equipped, check the Wash screen.
Yes Remove the shim from the
Buffer panel icons. empty container and slide it If the Wash Buffer
Blinking: Change all low wash into place on the new
Estimated % Full field is
container
buffer containers. If there is only red, change all low wash
one on-board container, load buffer containers. If there is
two new containers. Press the disconnect button Remove the empty container only one on-board container,
Solid: Change the wash buffer on the empty container to from the drawer and set it load two new containers.
release the tubing beside the new container
container that is not in use. If the Wash Buffer
If you cannot determine the Estimated % Full field is
in-use container, consult the Remove the empty container
Remove the cap and tube yellow, change the wash
assembly from the empty
Bulk Supplies screen. from the drawer and replace
container and insert it into
buffer container that is not in
it with the new container
the new container use.
Remove the cap and tube

assembly from the empty Tighten the cap and set the
container and insert it into new container in the drawer
the new container
Connect the tubing to the Route the tubing alongside

new container and close the the new container and close
drawer the drawer
2018E.svg

C96782-AA
Adding RVs
Check the RV status to determine how many bags of RVs to add to the vessel hopper. When the vessel hopper
is empty, the system completes any in progress tests, but does not schedule any new tests until you add more
RVs.
WARNING
To avoid contaminating the RV supply, only add full, previously unopened bags to the hopper
whenever it is possible. If you add a previously opened bag of RVs to the hopper, be sure the bag was
closed to protect the RVs from dust and other contaminants.
CAUTION
Only add UniCel DxI system RVs to the hopper. If you add other RVs or containers, the instrument
will malfunction.

System Status Panel
Check the Bulk Supplies screen
Check the RVs panel icon for the
for RV status
number of RVs required

System Status Panel Open the vessel hopper door Consult the Bulk Supplies screen to
If equipped, check the RVs panel determine how many RVs to add.
icon. If there are fewer than 100 RVs,
Blinking: Add enough RVs to fill add enough RVs to fill the vessel
Open a bag of RVs and pour
the vessel hopper (nearly two bags). the contents into the vessel hopper (nearly two bags).
hopper
Solid: Add one bag of RVs. If there are between 100 and 1000
RVs, add one bag of RVs.
Close the vessel hopper

door
2019D.svg

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Changing a Full Bulk Liquid Waste Container

Use this procedure only if your system uses bulk liquid waste containers. Check the liquid waste status to
determine which container is in use and how many containers to change. When all on-board containers are full,
the system completes any in progress tests, but does not schedule any new tests until you change at least one
container.
WARNINGS
• Thoroughly flush any decontaminant from the bulk liquid waste container before you store the
container. If you reuse a container without flushing it, any remaining decontaminant may react
with chemicals dispensed into the waste container. The resulting chemical reactions may create
gases harmful to you or the instrument.
• Reagents, calibrators, and controls used with the system may contain small quantities of sodium
Hazards (8/18/76).

System Status Panel
Check the Liquid Waste panel icons
container status
Pull out the liquid waste

UniCel DxI system with drawer UniCel DxI 600 or 800 System
System Status Panel Consult the Bulk Supplies screen.
If equipped, check the Liquid Press the disconnect button If the Liquid Waste Estimated %
on the full container to
Waste panel icons. release the tubing
Empty field is red, change all
Blinking: Change all liquid waste liquid waste containers. If there is
containers. If there is only one Remove the full container only one on-board container, load
and replace it with an empty
on-board container, load two new container two new containers.
containers. If the Liquid Waste Estimated %
Solid: Change the liquid waste Connect the tubing to the Empty field is yellow, change the
empty container and close
container that is not in use. the drawer liquid waste container that is not in
use.
If you cannot determine the in-use
Decontaminate the contents
container, consult the Bulk of the full container and
dispose of the
Supplies screen. liquid waste
Rinse the container

thoroughly and store it for
future use
2020D.svg

C96782-AA
Changing a Full Solid Waste Container

Check the solid waste status. When the container is full, the system completes any tests in progress, but does not
schedule any new tests until you change the solid waste container bag.
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.
CAUTIONS
• If you change a full solid waste container while the system is in the Running or Paused mode, be
sure to complete the procedure within five minutes. Solid waste may accumulate and obstruct the
waste chute if it takes longer than five minutes to change the container.
• Do not overfill the solid waste container. Excess solid waste may obstruct the waste chute.
• Do not open the solid waste door while the system is initializing, running a Daily Clean System
routine, or running a Special Clean routine. Opening the solid waste door will cancel the routine
and the system will enter the Not Ready mode.

System Status Panel
Check the Solid Waste panel icon
container status

System Status Panel Pull down on the solid waste
door handle Consult the Bulk Supplies screen.
If equipped, check the Solid Waste
If the Solid Waste Estimated %
panel icon.
Empty field is red, change the solid
Slide the full container out of
Blinking: Change the solid waste the storage area and seal waste container.
the waste bag
container.
If the Solid Waste Estimated %
Solid: The solid waste container is Empty field is yellow, the solid
almost full, change the container Remove the full waste bag waste container is almost full,
and insert a new bag into the
soon. container change the container soon.
Slide the empty container

and bag into the storage
area
Press the green reset button

and close the door
2021D.svg

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Loading a Reagent Pack

When a reagent is not present, an on-board pack does not contain enough reagent to process the requested tests,
or if the lot or open pack stability has expired, the system assigns the Supply Wait status to those tests and turns
the Supplies Required button yellow. On a UniCel DxI 800 system equipped with the system status panel, the
Console panel icon also is lit.
WARNINGS
• Do not load partial packs from another UniCel DxI or Access system onto your instrument.
• If you load a used pack, make sure the number of tests displayed for the pack is less than 50.
Erroneous but believable results may be obtained if a used pack is incorrectly identified as a new
pack containing 50 tests. If a used pack is identified as a new pack, unload it and use this
procedure to load a fresh pack.
CAUTION
To prevent damaging the reagent packs, be sure they are properly seated in the tray positions.
Check the status of the

reagent tray in-use light
No Wait until the green light

Is the light off?
turns off
Yes
Gently mix the packs and

open the reagent load door *
* For the Access 25(OH)

DxI 800: Vitamin D Total assay, see
Place up to 4 packs in the the reagent IFU for reagent
tray positions pack mixing instructions
DxI 600:
Place up to 2 packs in the
tray positions
Close the reagent load door
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C96782-AA
Unloading a Reagent Pack

The UniCel DxI system automatically unloads empty reagent packs and places them in the solid waste
container. Use this procedure to manually unload a reagent pack from the instrument.
WARNING
NOTES
• You can unload up to four reagent packs at a time on the Reagent Supplies screen for the
UniCel DxI 800 instrument (up to two packs on the UniCel DxI 600 instrument). You can only unload
packs one at a time on the Reagent Inventory screen.
• If a reagent pack is in use, you cannot unload it from the system (identified by the in-use [padlock] icon
on the Supplies screen).
(Any Screen)
Bulk Supplies
Reagent Supplies F1 Reagent Inventory F8
Reagent Supplies Reagent Inventory

DxI 800:
Select up to 4 reagent packs
DxI 600: Select one reagent pack
Select up to 2 reagent packs
Unload Reagent Pack F2 Unload Reagent Pack F2
Wait for the reagent tray

in-use light to turn off
Open the reagent load door

and remove the packs
Close the reagent load door
2023C.svg

C96782-AA
UniCel DxI Instructions for Use 4: Racks and Sample Containers
4 Racks and Sample Containers

You load sample containers onto the UniCel DxI instrument in sample racks. Each rack holds up to four sample
containers in the available rack positions. The onload area of the sample presentation unit (SPU) of the
UniCel DxI 800 instrument holds approximately 30 sample racks. The onload area of the UniCel DxI 600
instrument holds approximately 15 racks.
Racks
There are four sample rack sizes: 13 x 75 mm, 13 x 100 mm, 16 x 75 mm, and 16 x 100 mm.
Sample racks are identified by four different labels: Rack bar code label, Container type label, Rack ID label,
and the Reserve Volume label.
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
Flexible Reserve Standard Reserve No Reserve
7 Rack ID label

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The rack bar code label includes the bar code and rack ID number. The container type label includes an
illustration of the only sample container type you can use with the rack. The Rack ID label distinguishes one
sample rack from another, and also identifies the accepted sample container type for the rack. The Reserve
Volume label indicates what type of reserve volume is designated for the rack.
NOTE
You can find the rack ID ranges set up for each type of sample container from the System Setup screen.
The instrument recognizes the type of sample containers held in the sample rack when it scans the rack bar code
label.
Calculating Minimum Sample Volume

The sample volume in a container must be sufficient to process the requested tests, and can be increased to
accommodate reflex tests or patient and QC reruns.
Use this equation whenever you need to calculate the minimum sample volume for a container in a rack:
A B C D E
Minimum sample
Sample assay + System dead + Reserve volume + Sample pipettor + Sample container = volume required
volume volume (if set up) overdraw dead volume
2223B.wmf
A The sample assay volume is the sum of the sample volumes for each requested test. To find
the sample volume for each test, see the corresponding reagent instructions for use.
B The system dead volume is the amount of sample that cannot be drawn from an RV inside
of the instrument. The system dead volume is 60 µL for each RV.
C (If set up) The reserve volume is the amount of sample the system stores for additional
testing.
D The sample pipettor overdraw is 20 µL or 5% of the volume of sample in the RV (A + B +
C), whichever is greater.
E The sample container dead volume is the amount of sample that cannot be aliquoted from
the sample container.
NOTE
If the sum of the sample and reserve volumes (A + C) is greater than 500 µL, the system aliquots the
reserve volume into 1-2 additional reaction vessels (RVs). For each additional RV, include the system dead
volume and sample pipettor overdraw calculation.

C96782-AA
Example
Sample volume aliquot in one RV - The PSA assay has a sample volume of 25 µL, and the fPSA assay
has a sample volume of 25 µL. The system is set up to draw 200 µL of reserve volume. Here is how to
calculate the minimum sample volume required for these two assays if you are using a 2 mL cup.
A Total sample volume for the requested tests 50 µL

(25 µL + 25 µL)
B System dead volume for one RV 60 µL
C Reserve volume (Standard or Flexible) 200 µL
D Overdraw of 20 µL or 5% of the volume in the RV, whichever is larger 20 µL
One RV: 5% of (50 µL + 60 µL + 200 µL) = 16 µL,
so use an overdraw of 20 µL
E Dead volume for a 2 mL cup 150 µL
Minimum sample volume required for one RV 480 µL
Example
Sample volume aliquot in two RVs - The PSA assay has a sample volume of 25 µL, and the fPSA assay
has a sample volume of 25 µL. The system is set up to remove 500 µL of reserve volume. Here is how to
calculate the minimum sample volume required for these two assays if you are using a 2 mL cup.
.
A Total sample volume for the requested tests 50 µL

(25 µL + 25 µL)
B System dead volume for two RVs 120 µL
(60 µL + 60 µL)
C Reserve volume (Standard or Flexible) 500 µL
D Overdraw of 20 µL or 5% of the volume for each RV, whichever is larger 48 µL
First RV: 5% of (50 µL + 60 µL) = 6 µL,
so use an overdraw of 20 µL
Second RV: 5% of (60 µL + 500 µL) = 28 µL
E Dead volume for a 2 mL cup 150 µL
Minimum sample volume required for two RVs 868 µL

C96782-AA
Sample Containers
The following table lists the sample containers that are accepted on the UniCel DxI instrument, along with their
dead volume requirements.
WARNING
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 container in a rack may damage the
system and compromise the integrity of your test results. You can find the rack ID ranges set up for
each type of container from the System Setup screen.
CAUTION
Remove caps from all sample containers before loading on the UniCel DxI system.
Container Type Container Type

Sample Container Information Sample Container Information
Label Label
11.5x66 mm 3.5 mL S.60.549 12 or 13x75 mm glass tube
Sarstedt tube
Glass
• Dead volume: 500 µL
• Dead volume: 200 µL • Sample rack: 13x75 mm
• Sample rack: 13x75 mm
12/13
x75
12 or 13x75 mm plastic tube 13x100 mm tube

Plastic
• Dead volume: 200 µL • Dead volume: 500 µL

• Sample rack: 13x75 mm • Sample rack: 13x100 mm
12/13
x75 13x100
15.3x92 mm 5 mL S.62.611 16x75 mm tube

Sarstedt tube • Dead volume: 800 µL
• Dead volume: 300 µL • Sample rack: 16x75 mm
16x75
16x85 mm tube 16x100 mm tube

(This information only applies to • Sample rack: 16x100 mm
the 16x85 mm SBCL 10 mL
screw-cap tube)
16x85 16x100

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Container Type Container Type

Sample Container Information Sample Container Information
Label Label
75x15 mm 5.5 mL 92x15 mm 7.5 mL
Sarstedt S-Monovette tube Sarstedt S-Monovette tube
Beckman Coulter 1 mL insert cup in Beckman Coulter 1 mL insert cup in
Insert
Insert
a 13x75 tube a 13x100 mm tube
1 mL in 1 mL in
13x75 13x100
Beckman Coulter 0.5 mL cup Beckman Coulter 2 mL cup
• Sample rack: 13x75 mm or • Sample rack: 13x75 mm or
13x100 mm 13x100 mm
2 mL
Beckman Coulter 2 mL insert cup in Beckman Coulter 3 mL cup in a

Insert
a 16x100 mm tube 16x100 mm rack

2 mL in
16x100 3 mL
Beckman Coulter autoaliquot tube Beckman Coulter pediatric insert

(use only Beckman Coulter P/N cup in a Beckman Coulter pediatric
2910034) tube adapter
Aliquot PED

C96782-AA
UniCel DxI Instructions for Use 5: Sample Manager
5 Sample Manager
Sample processing begins when the UniCel DxI system queries the laboratory information system (LIS) for
sample test requests, downloads test requests from the LIS, or when a test request is entered on the Test
Requests screen.
Downloading LIS Test Requests

Use this procedure to process test requests downloaded from the LIS. When you load bar coded sample
containers for the samples listed on the Work Pending screen, the system matches the downloaded test requests
to the samples and runs the tests.
WARNING
NOTES
• When downloading test requests, be sure that LIS host query is not enabled.
• When setting up new tests to run on the instrument, enable the tests before downloading test requests
from the LIS. The system rejects an LIS test request if the associated test is not enabled.
System Mode: Ready Running Paused
(Any Screen)
Work Pending
Check the screen for test

requests downloaded
from the LIS
Review the screen when the

No Are there LIS Yes Place the samples listed on
Work Pending button turns
requests? the screen in racks
yellow
Load the racks, loading any

racks with STAT samples
first
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C96782-AA
Querying the LIS for Test Requests

Use this procedure to query the laboratory information system (LIS) for test requests.
System Mode: Ready Running Paused
NOTES
• Be sure that LIS host query is enabled.
• When setting up new tests to run on the instrument, enable the tests before querying the LIS for test
requests. The system rejects an LIS test request if the associated test is not enabled.
1. Place the bar coded sample containers in racks.
NOTE
If the reserve volume feature is enabled, be sure to place containers with sufficient volume in racks that are
set up to draw reserve volume.
2. Load the racks. Load any racks that contain STAT samples first.
3. The system scans the bar code labels for each sample container in the rack, queries the LIS for the
associated test requests, and then waits for the LIS to send the requests.
NOTES
• You set the length of time the system waits for a request in the LIS Setup window.
• If the system does not receive a test request within the specified time period, the system does not
remove an aliquot for processing and moves to the next container in the rack. The container with no
assigned test requests is not placed in the work pending list. The container must be reloaded after the
system aliquots the remaining samples in the rack.
4. When the system receives the test requests from the LIS, it updates the Sample Manager screen and scans
the bar code label on the next sample container in the rack.

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Manual Test Requests

Use this procedure to manually enter patient test requests that do not originate from the LIS.
WARNING
Sample Manager
NOTE
Manually requested patient test
results are evaluated against
default ranges, even if your
New Request F3
laboratory has established
reference, critical, or LIS ranges.
Patient/QC Requests F1 For more information, see Ranges
Setup in the Help system.
Test Requests
Enter the rack ID, sample ID,

sample information,
and test requests
for each sample
Verify the sample and test

information for the rack
Does the rack No Are all tests No

New Request F3
contain a STAT requested?
sample?
Yes Yes
Place the requested samples

in a rack
Load the rack
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C96782-AA
Calibration Test Requests

Use this procedure to request a calibration, which can consist of up to seven calibrator samples.
WARNING
NOTE
Before you can enter a calibration request, the calibrator must be set up, the test must be enabled, and
sufficient reagent must be in inventory.
Sample Manager
New Request F3
Calibration F2
Request Calibration
Select the calibrator lot
OK F1
Test Requests
Enter the rack ID and

press [Enter]
(Repeat as needed)
Place the samples in the

racks and exit the Test
Requests screen
Load the racks
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C96782-AA
Quality Control Test Requests

Use this procedure to enter a test request for a quality control sample or a multi-level set of samples.
You should run quality control samples as recommended in the reagent instructions for use and after any
scheduled or unscheduled maintenance to verify assay calibration. After installing new software, run quality
controls for all assays you use to report patient results, then recalibrate any assays with out-of-range quality
control results. You may choose to run quality controls more frequently based on good laboratory practices or
laboratory accreditation requirements and applicable laws.
WARNING
NOTE
You can run tests on patient samples and QC samples in the same rack, even if different tests are requested
for each sample.
Sample Manager
New Request F3
Patient/QC Requests F1
Test Requests
Enter the rack ID and press

[Enter]
Request QC F5
Request QC
Select quality controls
OK F1
Test Requests
Select tests for each quality

control
Place the samples in the

rack and load the rack
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C96782-AA
UniCel DxI Instructions for Use 6: Maintenance
6 Maintenance
Maintenance Overview
Routine maintenance for the UniCel DxI system includes the following maintenance procedures:
• Daily maintenance
• Special weekly maintenance
• Maintenance after a 5,000 test interval
• Maintenance after a 10,000 test interval
• The Utility routine
Daily maintenance consists of procedures for preparing the system to process samples each day. When the
10,000 and 5,000 test interval procedures are scheduled on the same day, always end by performing daily
maintenance.
Special weekly maintenance is only for laboratories that run tests for HIV antibody levels. Special weekly
maintenance consists of a procedure for installing clean aspirate probes.
Maintenance after a 5,000 test interval consists of a procedure for replacing the duck bill valve.
Maintenance after a 10,000 test interval consists of cleaning and closely inspecting internal components and
tubing connections. The 10,000 test interval procedures include a step to perform 5,000 test interval
maintenance before the 10,000 interval procedures are complete.
The Utility routine primes the reagent pipettors, aspirate probes, and dispense probes. The system automatically
runs the routine every four hours if the system is not processing samples. You can also run the Utility routine
manually. The Utility routine should always be enabled. If the Utility routine is disabled, you should enable the
routine and prime fluidics before running a clean routine as part of your daily maintenance procedures.
A technical support representative will schedule periodic preventive maintenance procedures on your
UniCel DxI instrument in accordance with the terms of your service agreement, if applicable.

C96782-AA
Maintenance Overview Flowchart
Begin 10,000 test maintenance Begin the remaining 10,000 1 - Remove and inspect the dispense
at the Diagnostics menu test interval maintenance probes
procedures ** 2 - Inspect pump connections at the
wash buffer reservoir
Device Diagnostics F4 3 - Inspect the upper aspirate peristaltic
pump connections
Close the right 4 - Inspect the reagent pipettors and
Device Diagnostics main upper cover clean the wash towers
5 - Inspect for fallen RVs
Exit the Device Diagnostics

screen and initialize
the system
1 - If your system uses bulk liquid
waste containers, inspect the liquid
Open the right waste drawer
main upper cover Complete the remaining 2 - Inspect the wash buffer supply
10,000 test interval drawer
maintenance procedures **
3 - Clean the air filter
Install clean*
aspirate probes **
1 - Back up the system
(weekly if testing for HIV
levels or at 10,000 test Perform daily maintenance ** 2 - Record the test count
interval maintenance) 3 - Shake down the solid waste
container
4 - Run a clean routine
Replace the duck bill valve **
Run QC and evaluate any
(5,000 test interval
out-of-range results to verify
maintenance)
system performance **
* Clean the used aspirate probes after ** Record that the procedure is
you complete all other maintenance complete on the Maintenance Log
procedures
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Daily Maintenance
Beckman Coulter recommends that you perform daily maintenance once every 24 hours. Perform daily
maintenance prior to beginning your daily workload. If your laboratory runs the instrument continuously,
perform maintenance at the end of the longest period of inactivity. Even if the system is not used routinely,
perform daily maintenance each day.
Perform daily maintenance to prepare the instrument to process samples for the day.
• Back up the system
• Record the test count
• Shake down the solid waste container
• Run a clean routine
Perform one of two clean routines each day to clean the sample, reagent, and aspirate probes. Run the Special
Clean routine daily if your laboratory has run the Vitamin B12 assay during the last 24-hour time period.
Otherwise, run the Daily Clean System routine.
NOTE
You can load patient sample racks while a clean routine is in process. Samples are aspirated after the clean
routine rack is aspirated, and are held in the sample wheel until the clean routine is complete.
If the special weekly maintenance procedure is scheduled, perform the daily maintenance procedures after you
complete the weekly procedure. If the 10,000 or 5,000 test interval maintenance procedures are scheduled,
perform the daily maintenance procedures after you complete the test interval procedures.
Performing Daily Maintenance
Required Materials
• A backup tape (if your DxI system uses a tape drive for backup)
• Sample containers that hold at least 4 mL of solution
• Sample rack with the appropriate rack ID for the container used
• UniCel DxI wash buffer
• Contrad 70 cleaning solution
• 1:5 dilution of Citranox cleaning solution - mix 1 part Citranox and 4 parts deionized water
• 70% ethanol solution—mix 7 parts of 95% ethanol and 3 parts wash buffer (alternatively, you can
substitute methanol for the 95% ethanol) (Special Clean routine only)
• Maintenance Log

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WARNINGS
• 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.
• Contrad 70 cleaning solution is alkaline and may cause severe eye irritation or mild skin
irritation. Handle according to proper laboratory procedures. See the manufacturer’s label for
details.
• 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
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 from the System
Setup screen.

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Daily Maintenance Flowchart
WARNINGS
• Ethanol and methanol are extremely flammable. Do not fill sample tubes on the instrument or in
a rack positioned in the sample presentation unit. Remove sample tubes from the instrument
immediately after completing the Special Clean routine.
System mode: Ready
Back up the system *
Event Log Request Maintenance
Clean Routine Options

With the Utility routine
Select the most recent event Daily Clean System
enabled, select a
listed on the screen Special Clean: Select if you have run the Vitamin B12
clean routine
assay in the last 24 hours
Details F4 OK F1
Maintenance Requests
Record the instrument test
count on the Maintenance
Log
Enter the rack ID and press
[Enter]
Shake down the solid waste

container * Positions
1 - Add 3 mL Contrad 70
Prepare and load a rack 2 - Add 3 mL 1:5 dilution of Citranox
3 (Special Clean only) - Add 4 mL 70%
Sample Manager Ethanol solution
Time to Completion
The system begins the clean
Daily Clean System: Approximately 10 minutes
routine *
Special Clean: Approximately 13 minutes
New Request F3
Maintenance F3 * Record that the procedure is

complete on the Maintenance
Log
2105F.svg

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Special Weekly Maintenance

If your laboratory runs tests for HIV antibody levels, Beckman Coulter recommends that you perform special
weekly maintenance. Special weekly maintenance consists of a procedure for installing clean aspirate probes.
Laboratories that install clean aspirate probes during special weekly maintenance are not required to install
clean probes during 10,000 test interval maintenance.
After you complete the special weekly maintenance procedure, perform daily maintenance and verify system
performance.
Special Weekly Maintenance Flowchart
Begin special weekly

maintenance at the Device Diagnostics F4
Diagnostics menu
Device Diagnostics
WARNINGS
• You will come in
contact with potentially screen and initialize
infectious materials the system
during this procedure.

Handle and dispose of
biohazard materials
Open the right Perform daily maintenance *
according to proper
main upper cover
laboratory procedures.
Proper hand, eye, and
facial protection is
required. Install clean aspirate Verify system performance *
probes *
• Never wear exposed
metal that can come
into contact with * Record that the procedure
electrical components is complete on the
Close the right Maintenance Log
of the instrument. main upper cover
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Test Interval Maintenance: 5,000 Tests

Beckman Coulter recommends that you replace the duck bill valve after each 5,000 test interval. The duck bill
valve prevents wash buffer from entering the RVs in the wash carousel during the aspirate probe wash.
If the 10,000 and 5,000 test interval maintenance procedures are scheduled for the same day, begin with the
10,000 test interval maintenance procedures. The 10,000 test interval procedures include a step to perform
5,000 test interval maintenance. Perform the daily maintenance procedures after you complete the 10,000 and
5,000 test interval procedures.
Test Interval Maintenance: 5,000 Tests Flowchart
Begin 5,000 test

maintenance at the Device Diagnostics F4
Diagnostics menu
Device Diagnostics
WARNINGS
• You will come in
contact with screen and initialize
potentially the system
infectious materials
during these
procedures. Handle
and dispose of
Open the right main upper Perform daily maintenance *
biohazard materials cover
according to proper
laboratory
procedures. Proper
hand, eye, and facial
protection is Verify system performance *
Replace the duck bill valve *
required.
• Never wear exposed
metal that can come
into contact with
Close the right main * Record that the procedure
electrical
upper cover is complete on the
components of the Maintenance Log
instrument.
2300D.wmf

C96782-AA
Replacing the Duck Bill Valve

Use this procedure to replace the duck bill valve. Replace the duck bill valve 5,000 tests after the valve was last
replaced, or as instructed by the system documentation, or by a technical support representative.
WARNINGS
• Never wear exposed metal that can come into contact with electrical components of the
instrument.
CAUTIONS
• Opening the covers abruptly shuts off power to the upper cabinet, and may cause damage if the
system is not in the proper mode and the user interface is not displaying the correct screen.
Follow this procedure carefully.
• Before you begin this procedure, verify that you have a replacement valve in your CARE kit. If
there is no replacement valve, do not perform this procedure. Order a new set of valves and
replace the duck bill valve at your earliest opportunity.
Required Materials
• An empty sample rack
• Several clean lint-free tissues
• New duck bill valve

C96782-AA
Replacing the Duck Bill Valve Flowchart

WARNINGS
instrument.
For 5,000 test maintenance, begin this If continuing from 10,000 test
procedure at the Diagnostics menu maintenance, begin the procedure here
Device Diagnostics F4 Push the wash collar up

Turn the wash collar Remove the sample rack
through the key slot and turn
clockwise and pull the collar from beneath the dispense
the collar counterclockwise
down through the key slot probe plate
to secure
Device Diagnostics
Turn the retaining nut

Return the A1 aspirate probe Close the right main
counterclockwise and
to its proper place upper cover
remove from the wash collar
Lift the duck bill valve out of

the retaining nut and discard Tighten the probe fitting and Exit the Device Diagnostics
Open the right main
the valve in the biohazard verify the aspirate probe screen and initialize
upper cover
waste deflection the system
Gently lift the dispense probe Record that the procedure is Perform daily maintenance
Insert a new valve into
plate and slide a sample rack complete on the and verify system
the retaining nut
beneath the plate Maintenance Log performance
Loosen the A1 aspirate Attach the retaining nut

probe fitting and to the wash collar Continue with
remove the probe by turning it clockwise No
10,000 test
maintenance?
Yes
Inspect the duck bill valve
Remove and inspect the

dispense probes
No Is the valve Yes

closed?
Confirm that the dispense

For more information,
probe tubing is routed
see page 6-14
correctly
2240K.wmf

C96782-AA
Test Interval Maintenance: 10,000 Tests

Beckman Coulter recommends that you perform the following maintenance procedures after each 10,000 test
interval:
• Install clean aspirate probes
• Remove and inspect the dispense probes
• Inspect the pump connections at the wash buffer reservoir
• Inspect the upper aspirate peristaltic pump connections
• Inspect the reagent pipettors and clean the wash towers
• Inspect for fallen RVs
• If your system uses bulk liquid waste containers, inspect the liquid waste drawer
• Inspect the wash buffer supply drawer
• Clean the air filter
NOTE
If your laboratory runs tests for HIV antibody levels, you will install clean aspirate probes each week as
part of special weekly maintenance instead of installing clean probes during 10,000 test interval
maintenance.
The 10,000 test interval maintenance procedures include a step to perform 5,000 test interval maintenance
before the 10,000 interval procedures are complete. Perform the daily maintenance procedures after you
complete the 10,000 and 5,000 test interval procedures.
Required Materials
• Several clean, lint-free tissues
• Three clean aspirate probes
• Proper hand, eye, and facial protection
• Small beakers (2)
• Contrad 70 cleaning solution
• Disposable aspirate probe brush
• Deionized water
• Syringe and syringe fitting assembly
• Alcohol wipe
• Hand-held vacuum device

C96782-AA
Test Interval Maintenance: 10,000 Tests Flowchart
WARNINGS
instrument.
Begin 10,000 test maintenance

at the Diagnostics menu
Is 5,000 test No
maintenance
Device Diagnostics F4 scheduled?
Device Diagnostics Yes
Inspect the reagent pipettors Inspect the wash buffer

Replace the duck bill valve *
and clean the wash towers * supply drawer *
Remove and inspect the

Inspect for fallen RVs * Clean the air filter *
Open the right dispense probes *
main upper cover
Install clean Open the left Close the left and right
aspirate probes * Perform daily maintenance *
main upper cover main upper covers
(unless your lab installs
clean probes weekly
for HIV testing)
Inspect the pump Exit the Device Diagnostics

connections at the wash screen and initialize Verify system performance *
buffer reservoir * the system
* Record that the procedure

If your system uses bulk is complete on the
Inspect the upper aspirate
liquid waste containers, Maintenance Log
peristaltic pump
inspect the liquid waste
connections *
drawer*
2260G.svg

C96782-AA
Installing Clean Aspirate Probes

WARNINGS
instrument.
For 10,000 test maintenance,

begin this procedure at
the Diagnostics menu
Device Diagnostics F4 Gently lift the dispense probe

Disconnect the tubing fitting
plate and slide a sample rack
from the manifold
beneath the plate
Device Diagnostics
Turn the probe fitting Connect the tubing fitting

* Clean the removed aspirate
counterclockwise to loosen of a clean probe to the
probes after you complete all
the aspirate probe manifold *
other maintenance procedures
Lift the aspirate probe out of Correctly route the probe

Open the right the aspirate probe plate and tubing and place the clean
main upper cover set the probe on lint-free aspirate probe in its proper
tissues position in the probe plate
Tighten the probe fitting and

verify the aspirate probe
deflection
Are there
Yes more aspirate
probes to remove
and install?
Record that the procedure is No

Replace the duck bill valve
complete on the
and record that the
Maintenance Log Perform daily maintenance
procedure is complete on the
and verify system
Maintenance Log
performance
Yes
Are you
Are you performing Is 5,000 test Continue with
only installing No special weekly No No Yes Remove and inspect the
maintenance 10,000 test
clean aspirate maintenance? dispense probes
scheduled? maintenance?
probes?
Yes Yes No
screen and initialize
the system
For more Confirm that the dispense Remove the sample rack
Close the right
information, see probe tubing is routed from beneath the dispense
main upper cover
page 6-14 correctly probe plate
2266J.wmf

C96782-AA
Cleaning an Aspirate Probe
WARNINGS Brush out the inside of the

Remove aspirate probe
aspirate probe with
fitting from deionized water
• You will come in contact with Contrad 70
potentially infectious materials

during this procedure. Handle and
Reattach the syringe to the
dispose of biohazard materials Place the aspirate probe fitting assembly and draw air
fitting in deionized water through the tubing fitting and
according to proper laboratory into the syringe
procedures. Proper hand, eye, and
Attach the syringe fitting Disconnect the syringe and
• The disposable aspirate probe brush assembly to the aspirate fitting assembly from the
probe tip probe tip
is considered a biohazard after it
has been used to clean from 1 to 3
aspirate probes. Discard the brush
Draw deionized water Position the probe upright on
with your biohazard waste. Do not through the tubing fitting and absorbent paper for 10
save a used brush for future use. into the syringe minutes
• When cleaning a probe, inserting

and removing the aspirate probe
Disconnect the syringe from Wipe down the aspirate
brush can disperse biohazard the fitting assembly and probe exterior with an
discard the water in the sink alcohol wipe
materials that are lodged inside the
probe. Work carefully to prevent
scattering small droplets of these Reattach the syringe to the
materials into the air. fitting assembly and draw Store the clean aspirate
and discard water two more probes in your CARE kit
times
2267C.wmf
Removing and Inspecting the Dispense Probes

WARNINGS
instrument.

C96782-AA
Begin this procedure at

the Diagnostics menu
Lift the dispense probe out of
the dispense probe plate and
Device Diagnostics F4 inspect the probe
Device Diagnostics
Is the
Moisten a lint-free tissue with
probe free of No
deionized water and wipe
crystalline
down the probe exterior
deposits?
Yes
Open the right

main upper cover
Correctly route the dispense
probe tubing
For more information,
see Figure 7-15 3
Locate the dispense probes
and inspect the tubing
connections and fittings Place the dispense probe in 2
its proper position in the
probe plate
Inspect for kinked tubing and

for deposits or corrosion at
the fittings and connections
Tighten the probe fitting
Turn the probe fitting

counterclockwise to loosen
the dispense probe
Remove the sample rack

No from beneath the dispense
Are all probes probe plate
Correctly Routed
inspected? Dispense Probe
Tubing
1: Dispense probe strain
Yes
Continue with relief (in gray)
10,000 test
No Close the right
maintenance?
main upper cover 2: Correct: The dispense
Record that the procedure is
complete on the probe strain relief is not
Maintenance Log routed beneath the
Yes aspirate probe plate and
Exit the Device Diagnostics support arm
screen and Initialize
Confirm that the dispense the system 3: A1 aspirate probe
Inspect pump connections at
probe tubing is routed
the wash buffer reservoir tubing routed above the
correctly
aspirate probe plate and
support arm
Verify system performance
2268J.svg

C96782-AA
UniCel DxI system Maintenance Log Serial # _________ System ID ___________ Month _______Year ______
DAILY MAINTENANCE 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Back Up the System
Record the Test Count
(Turn form to record
number)
C96782-AA
Shake the Solid Waste
Container
Run the Daily Clean
Routine (D) D D D D D D D D D D D D D D D D D D D D D D D D D D D D D D D
Maintenance Log
or the Special Clean
© 2022 Beckman Coulter, Inc.

UniCel DxI Instructions for Use
S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S S
Routine (S)
Tech Initials
SPECIAL WEEKLY MAINTENANCE

On Date On Date On Date On Date On Date
(if running tests for HIV antibody levels)
Install Clean Aspirate Probes
Verify System Performance (Run Clean Routine and QC)
Tech Initials
5,000 TEST INTERVAL MAINTENANCE On Date On Date On Date On Date On Date On Date
Replace the Duck Bill Valve
Tech Initials
Complete the maintenance procedures in the order listed in
10,000 TEST INTERVAL MAINTENANCE On Date On Date On Date each table. When a maintenance procedure is complete, draw
a check () or circle the code in the corresponding box.
Install Clean Aspirate Probes
When all procedures are complete for a scheduled
Remove and Inspect Dispense Probes maintenance, add your initials. Add the date and test count as
Inspect the Pump Connections at the Wash Buffer Reservoir appropriate.
Inspect the Upper Aspirate Peristaltic Pump Connections If you schedule the 10,000 and 5,000 test interval
Inspect the Reagent Pipettors and Clean the Wash Towers maintenance procedures consecutively, perform the 10,000
test interval procedures first. Perform the daily maintenance
Inspect for Fallen RVs
procedures after you complete the 10,000 and 5,000 test
If your system uses bulk liquid waste containers, inspect the interval procedures.
Liquid Waste Drawer
When you combine daily maintenance with special weekly
Inspect the Wash Buffer Supply Drawer or test interval maintenance, you only need to run a clean
Clean the Air Filter routine once in your final maintenance step.
6: Maintenance
6-15
Tech Initials
This page may be reproduced for laboratory use.
UniCel DxI Instructions for Use 7: Troubleshooting
7 Troubleshooting
Event Log
The Event Log is a list of events the UniCel DxI system generates as it monitors the status of various system
parameters. You can use these events to keep informed of system operations and to assist with troubleshooting.
Troubleshooting Events
You can view technical information about an event 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, either print the event details or write down all of the
information displayed in the Details window.
QC Troubleshooting
QC results can fail for a variety of reasons including past-due maintenance, cold substrate, QC material
stability, reagent stability, calibrator stability, and instrument hardware or software problems.
Use the following procedure to troubleshoot QC problems.
NOTE
For assays that have more than one reagent pipettor assigned, any troubleshooting step that produces
acceptable QC results should be repeated on all pipettors that previously produced failed QC results.
1. Identify event log errors. Contact Technical Support if you need help troubleshooting event log errors.
2. Troubleshoot test result flags.
3. Verify that the sample container has sufficient volume, and has been loaded in the correct rack and the
correct sample container position. If not, correct the problem and repeat the test.
4. Verify that routine maintenance has been performed. If it has not, perform the required maintenance tasks
and then repeat the QC test.
5. Verify that the substrate was equilibrated to room temperature before being loaded. If it was not
equilibrated, repeat the QC test after the substrate has equilibrated. For the recommended temperature and
equilibration time, see the substrate reagent instructions for use.

C96782-AA
6. To eliminate random errors as a cause of the QC failure, pipette a fresh sample from the vial in use and
rerun the test. Use the Rerunning a QC Test procedure to ensure that the test is repeated with the same
reagent pipettor and reagent pack.
NOTE
Statistically, even with an appropriate mean and 2SD range, 1 of 20 QC results will be out of range, and
1 of 333 QC results will be out of the 3SD range.
7. Check for problems with QC materials:
Quality control material stability 1. Prepare new quality control according to the procedure
provided by the manufacturer.
2. Load the freshly prepared quality control and repeat the
test.
Wrong quality control loaded onto the sample rack 1. Load the correct quality control.
2. Repeat the test.
Wrong quality control lot number selected for the test Repeat the test using the correct lot number.
Wrong mean and/or standard deviation information 1. Review the QC information using Edit Control F2 from
entered when setting up the quality controls the QC Setup screen.
2. If necessary, edit the information.
3. Repeat the test.
WARNING
System Check Solution contains ProClin™ 300 preservative, which may cause sensitization by skin
contact. After contact with skin, wash immediately with soap and water. Wear suitable gloves.
8. Run the System Check routines. If results are out of range, contact Technical Support.
9. Identify any reagent pipettor that is producing failed QC results for all assays that run on that pipettor.
a. If QC failures are coming from one pipettor, clear the assignment of that pipettor in the test setup for
each failing assay.
b. If the pipettor that became unassigned in step a was the only pipettor assigned to a test, assign a
different pipettor to that test.
c. Repeat the QC test by entering a new QC test request.
NOTE
Because the reagent pipettor that was used for the failed QC test is no longer assigned to that test, you
cannot rerun the test by using the Rerunning a QC Test procedure.
d. If QC results from other pipettors are satisfactory, disable the failing pipettor on the Supplies Setup
screen until repairs can be made.
10. Recalibrate the assay to compensate for subtle changes in the instrument or reagent.
11. If none of the preceding steps resolve the problem, contact Technical Support.

C96782-AA
Rerunning a QC Test
If a quality control test produces questionable results, use this procedure to rerun the test. The system uses the
same reagent pipettor and reagent pack to eliminate random errors as a cause of the questionable result.

1. Go to the Test Results screen, then locate and select the result you want to rerun.
NOTE
Only select a single result. If you select a group of results and then select Rerun Test F3, only the result
indicated with the Arrow button is rerun.
2. Select Rerun Test F3. A message informs you that the test has been reordered, and the test is added to the
work pending list.
NOTE
After the test has been added to the work pending list, the test will be applied automatically to the next
request for that QC.
3. Go to the Sample Manager screen and select New Request F3, then select Patient/QC Requests F1 to
display the Test Requests screen.
4. Enter the rack ID in the Enter ID field and press [Enter].
5. Select Request QC F5.

The Request QC window is displayed.
6. Select the quality control to rerun. The test is automatically removed from the work pending list, and is
added to the test list for the quality control.
7. Complete the test request by exiting the Test Requests screen.
8. Place the QC sample in the rack entered in step 4, and load the rack on the instrument.
NOTE
If the reagent pipettor or the reagent pack are unavailable, the sample status will be changed to Supply Wait
and the test will not rerun until both the reagent pipettor and the reagent pack are available. When the
supply condition has been cleared, the test will rerun automatically.

C96782-AA
Test Result Flags and Troubleshooting

The following tables provide troubleshooting information associated with test result flags that are fatal (no
calculated result) or non-fatal (calculated result, but a condition exists for that result). Use the information to
identify and correct assay related problems. This information is also provided online when you select
Troubleshoot F2 from the Sample Details window.
WARNING
NOTE
Before performing corrective actions, make sure that you are familiar with the troubleshooting process.
Fatal Flags
Fatal Flag Description Corrective Action

AEX The aliquoted sample cannot be used 1. Review the Event Log for error events with a similar date and
for one or more of the following time to this event. If events are found, troubleshoot according to
reasons: available information or contact Technical Support.
• An error occurred when the aliquot 2. Make sure that required supplies are on board before running the
was dispensed into the vessel. test again.
• The aliquot has been on board the 3. Check the test status in the Result column of the Test Result
instrument for up to three hours and screen and take one of the following actions:
has expired. • For calibrator and maintenance samples with the test status
• The last test taken from the aliquot Cancelled: Request the test again and load a fresh quantity of
was completed one hour ago. sample.
• For patient and QC samples with the test status Requested:
Load a fresh quantity of sample. The test is run automatically.
CCR A result could not be calculated 1. Take one of the following actions:
because: • For results other than derived results, skip to step 2.
• One of the tests included in a • For derived results, review each test result used in the derived
derived result formula did not result formula. If a result failed, troubleshoot according to the
produce a result. flag for that result.
• A confirmatory test result could not 2. Review the Event Log for error events with a similar date and
be calculated. Usually this occurs time to this event. If events are found, troubleshoot according to
because the samples for the available information or contact Technical Support.
qualitative and confirmatory tests
3. Repeat the test.
were not aspirated at the same time.
• For a derived result, repeat all tests included in the derived
• Another error prevented the system
result formula.
from calculating a result.
• For a confirmatory result, repeat the confirmatory and
qualitative tests.

C96782-AA

CLT An obstruction was detected in the Check the test status in the Result column of the Test Result screen.
sample tube before aliquoting or in the • For patient and QC samples with the test status Requested:
RV during processing.
1. Take the necessary steps to remove or disperse the obstruction,
or obtain a fresh quantity of sample.
2. Load the sample. The test is run automatically.
3. If the problem persists, contact Technical Support.
• For samples with the test status Cancelled:
1. Take the necessary steps to remove or disperse the obstruction,
or obtain a fresh quantity of sample.
2. Determine if the Automatic Rerun feature is enabled and take
one of the following actions.
• If the Automatic Rerun feature is not enabled, proceed to
step 3.
• If the Automatic Rerun feature is enabled, the test has been
reordered automatically. Proceed to step 4.
3. Request the test again.
4. Load the sample.
Note: Do not load the sample for automatic rerun requests
unless the test has been added to work pending. If sufficient
reserve volume is onboard the instrument, and all other
supplies are acceptable, the test runs automatically.
IND • For sandwich assays, which use 1. For IND flagged results which meet the following criteria, dilute
positive slope calibration curves, and rerun the sample:
the result is at the low end of the • The result is on a competitive assay, and
concentration curve and cannot be
• Sample dilution is allowed for the assay, and
distinguished from a system failure
because the RLU reading is too • The sample RLU is low.
low. See the reagent instructions for use to determine the assay type
• For competitive assays, which use and whether sample dilution is allowed.
negative slope calibration curves, 2. Rule out a system problem by reviewing the Event Log for error
the result is at either: events with a date and time shortly before this event.
• The high end of the concentration Troubleshoot accordingly.
curve and cannot be distinguished 3. If you have ruled out a system problem and the IND flag event is
from a system failure because the the only issue, recalibrating the affected assay may resolve the
RLU reading is too low, or problem.
• The low end of the concentration • Recalibrate the assay using a new reagent pack and a new set
curve and cannot be distinguished of calibrators.
from a system failure because the • Run QC.
RLU reading is too high.
• Repeat the test on the affected sample.
If IND flags persist, contact Technical Support.
NCR No calibration data existed for the 1. Calibrate the assay.
reagent lot when the patient or QC 2. Repeat the test.
result was processed.

C96782-AA

QNS The sample volume is insufficient in Check the test status in the Result column on the Test Result screen.
the sample container or in the RV • For patient and QC samples with the test status Requested:
during processing.
1. Identify event log errors. Contact Technical Support if you
If the flag is applied because of need help troubleshooting event log errors.
insufficient volume in the RV, and
2. Pipette sufficient sample volume into the sample container and
Automatic Rerun is enabled, the test
make sure the rack is appropriate for the sample container.
will be reordered. Otherwise,
additional tests will not be scheduled 3. Load the sample. The test is run automatically.
for this sample. Tests already 4. If the problem persists, contact Technical Support.
scheduled will be completed. • For samples with the test status Cancelled:
1. Identify event log errors. Contact Technical Support if you
need help troubleshooting event log errors.
- If the Automatic Rerun feature is not enabled, proceed to
step 3.
- If the Automatic Rerun feature is enabled, the test has been
reordered automatically. Take one of the following actions.
- If sufficient reserve volume is not onboard the instrument,
the test is added to work pending. Proceed to step 4.
- If sufficient reserve is onboard the instrument, and all other
supplies are acceptable, the test runs automatically. Proceed
to step 6.
4. Pipette sufficient sample volume into the sample container and
make sure the rack is appropriate for the sample container.
5. Load the sample.
QSB A substrate dispense failure occurred 1. Prime the substrate for four cycles.
during processing. 2. Determine if the Automatic Rerun feature is enabled and take
step 3.
4. Load the sample.

C96782-AA

QSD Insufficient sample volume or reagent 1. Review the Event Log. Contact Technical Support if you need
volume was dispensed into an RV. help troubleshooting event log errors.
step 3.
4. Load the sample.
Note: Do not load the sample for automatic rerun requests unless
the test has been added to work pending. If sufficient reserve
volume is onboard the instrument, and all other supplies are
acceptable, the test runs automatically.
QSS Insufficient sample volume was Follow the Corrective Action instructions for the QSD flag.
withdrawn from the sample container
or from an RV.
RLU The relative light units (RLUs) are Follow the Corrective Action instructions for the QSD flag.
outside the acceptable luminometer
measuring range.
SYS A device error occurred during Follow the Corrective Action instructions for the QSD flag.
processing.
TRI The temperature of the analytical 1. Check the wash carousel temperature on the Maintenance
module was outside the acceptable Review screen. If the temperature is outside the acceptable
limits when the test was being limits, periodically monitor the wash carousel temperature on
incubated. this screen until it is within the acceptable limits.
• If the instrument was restarted or instrument covers were
recently opened, you may need to wait up to 10 minutes for
the temperature to normalize.
• If the system was powered down for an extended period of
time, you may need to wait up to one hour for the temperature
to normalize.
2. When the wash carousel temperature is within the acceptable
limits, determine if the Automatic Rerun feature is enabled and
take one of the following actions.
step 3.
4. Load the sample.
5. If the temperature does not normalize, or if the problem persists,
contact Technical Support.

C96782-AA

TRS The temperature of the substrate was 1. Check the substrate temperature on the Maintenance Review
outside the acceptable limits when the screen. If the temperature is outside the acceptable limits,
substrate was dispensed. periodically monitor the substrate temperature on this screen
until it is within the acceptable limits.
• If the instrument was restarted or instrument covers were
recently opened, you may need to wait up to 10 minutes for
the temperature to normalize.
to normalize.
2. When the substrate temperature is within the acceptable limits,
determine if the Automatic Rerun feature is enabled and take one
of the following actions.
step 3.
4. Load the sample.
TRW The temperature of the analytical Follow the corrective actions provided for the TRI flag.
module was outside the acceptable
limits when the reaction vessel was in
the wash carousel.
Non-Fatal Flags
Non-Fatal Flag Description Corrective Action

CEX The calibration curve or cut-off value 1. Recalibrate the assay.
is expired. 2. Repeat the test.
CLX The calibrator lot is expired. • For patient and QC tests: Review the Calibration Data screen to
Note: For patient and QC tests, the determine whether replicates of the active calibration are
calibrator lot may have expired after a associated with the CLX flag. Then take one of the following
successful calibration. actions:
• If the calibration is not associated with the flag, the patient or
QC test result is a valid result. No corrective action is
necessary.
• If the calibration is associated with the flag, and you did not
intend to run the QC or patient test using this calibration,
calibrate the assay again with a calibrator lot that has not
expired. Request the QC or patient test again.
• If the calibration is associated with the flag, and you intended
to run the QC or patient test using this calibration, no
corrective action is necessary.
• For calibrations: If you did not intend to calibrate with an expired
lot, run another calibration with a calibrator lot that has not
expired. Otherwise, no corrective action is necessary.

C96782-AA

CRH The patient test result is above the This is a valid test result. No corrective action is necessary.
upper limit of the critical range.
CRL The patient test result is below the This is a valid test result. No corrective action is necessary.
lower limit of the critical range.
DEX The open pack stability time has 1. Make sure sufficient unexpired diluent is available.
expired for the diluent pack. The 2. Repeat the test.
system measures open pack stability
separately by well.
Note: For an LIS attached to a DxI
instrument, the PEX flag is sent to the
LIS in place of the DEX flag.
EXS The substrate is expired. 1. Review the expiration date on the Bulk Supplies screen.
2. If necessary, change the substrate bottle.
3. Repeat the test.
GRY For qualitative assays, the patient or This is a valid test result. No corrective action is necessary.
QC result is within the specified gray In some cases, the GRY flag may be applied to a result with an S/CO
zone, also known as the equivocal value which appears to be at the upper or lower limit of the gray
zone. 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. If your laboratory prefers to avoid these situations, contact
Technical Support for instructions on setting the gray zone limits.
LEX The reagent or diluent pack lot is 1. Unload all of the packs from the expired reagent lot and load a
expired. pack from a new lot.
2. Repeat the test.
LOW The patient or QC result is lower than No corrective action is necessary.
the minimum reportable result value
defined in the APF.
LRH The patient result is above the upper 1. Review the result.
limit of the LIS range. 2. Take one of the following actions:
Notes: • Send the result to the LIS manually.
• If the Auto-Send to LIS option is • Delete the result and repeat the test.
set to Verify, the system does not
automatically send results with this
flag to the LIS.
• This flag is for quantitative assays,
semi-quantitative assays, and
derived results only.
LRL The patient result is below the lower 1. Review the result.
limit of the LIS range. 2. Take one of the following actions:
Notes: • Send the result to the LIS manually.
• If the Auto-Send to LIS option is • Delete the result and repeat the test.
set to Verify, the system does not
automatically send results with this
flag to the LIS.
• This flag is for quantitative assays,
semi-quantitative assays, and
derived results only.
ORH The patient result is above the upper No corrective action is necessary.
limit of the reference range.
ORL The patient result is below the lower No corrective action is necessary.
limit of the reference range.

C96782-AA

OVR The calculated concentration is above 1. Review the Event Log for error events with a similar date and
the highest or most concentrated time to this event.
calibrator. This flag is only used for • If events occurred, troubleshoot.
quantitative and semi-quantitative
2. Take one of the following actions:
assays.
• If events occurred, and you performed troubleshooting
procedures, run controls and then repeat the test.
- If the controls are in range, and the test result is reported as
greater than the value of the highest calibrator (>X), you
may be able to dilute the sample. To identify whether the
assay allows dilutions, see the reagent instructions for use.
- If the controls are not in range, follow the QC
troubleshooting instructions.
• If no events occurred, take one of the following actions:
- If the test result is reported as >X, you may be able to dilute
the sample. To identify whether the assay allows dilutions,
see the reagent instructions for use.
- If dilutions are allowed, dilute and repeat the test.
- If dilutions are not allowed, no further action is necessary.
3. If you have questions about the result, or if the problem persists,
PEX The open pack stability time has 1. Unload the expired reagent pack and load a new one.
elapsed for the reagent pack. The • If the lot number of the new reagent pack is different than the
system starts measuring open pack expired pack, recalibrate the assay.
stability when it first punctures the
2. Repeat the test.
pack.
Note: For an LIS attached to a DxI
instrument, the PEX flag is sent to the
LIS in place of the DEX flag.
QCF The quality control result violates one 1. Display the QC Chart and Data screen to review which criteria is
or more QC rules. not met.
2. Follow the QC troubleshooting instructions.
QEX The quality control lot is expired. 1. Add a new, unexpired quality control lot. Make sure that
expected means and SDs are established according to laboratory
guidelines.
2. Repeat the test.
RFX The patient sample result is from a No corrective action is necessary for this flag alone.
reflex test.
TRA The temperature of the sample wheel 1. Check the sample wheel temperature on the Maintenance
was outside the acceptable limits Review screen. If the temperature is outside the acceptable
when the sample aliquot was in the limits, periodically monitor the sample wheel temperature on
sample wheel. this screen until it is within the acceptable limits.
• If the system was restarted or instrument covers were opened
recently, you may need to wait up to 10 minutes for the
temperature to normalize.
to normalize.
2. When the sample wheel temperature is within the acceptable
limits, repeat the test.

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TRR The temperature of the reagent storage 1. Check the reagent storage chamber temperature on the
chamber was outside the acceptable Maintenance Review screen. If the temperature is outside the
limits when reagents were pipetted. acceptable limits, periodically monitor the reagent storage
chamber temperature on this screen until it is within the
acceptable limits.
• If the system was restarted or the instrument storage chamber
cover was recently opened, you may need to wait up to 10
minutes for the temperature to normalize.
to normalize.
2. When the reagent storage chamber temperature is within the
acceptable limits, repeat the test.

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UniCel DxI Instructions for Use 8: Theory of Operation
8 Theory of Operation
Sample Processing
The UniCel DxI Access Immunoassay System is an automated analyzer that performs a wide variety of
immunoassays on body fluid samples. The system starts sample processing when it receives a test request either
from the laboratory information system (LIS), or from the system console.
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 aliquot station, scans the bar codes on the rack
and sample tube, aliquots enough sample to complete all requested tests and replicates into one or more reaction
vessels (RVs), and stores the RVs 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.
Reserve Volume
The system can be set up to draw an additional volume of sample that can be used for system generated reflex
tests, LIS downloaded reflex tests, reruns, or late 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 when 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
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 SPU.
You enable the reserve volume feature and set up the standard quantity of sample to draw in the Reserve
Volume Setup window.
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.

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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.
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.
Onboard Dilutions*
Assays with the onboard dilution feature provide two tests in the assay protocol file (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 in
the Test Requests screen.
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 LIS.
Onboard dilution tests use the same processes and calibration curves as the corresponding parent tests. Onboard
dilution tests have test names beginning with d and they require separate setup, including ranges, units of
measure, default sample type, and decimal places.
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.
Supply and Calibration Verification

Before the system runs a test, it verifies that it has sufficient quantities of the required supplies. If supplies are
needed or waste containers need to be emptied, the system prompts you to take appropriate action.
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.
* The availability of the UniCel DxI onboard dilution feature in your country depends on the status of submissions to local regulatory
agencies. Please contact you Beckman Coulter representative if you have questions about the availability in your geography.

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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 Processing Order

The UniCel DxI system determines the optimal processing order using the criteria listed below. The system
processes the samples with the highest priority first.
Processing Order Criteria
1 STAT samples
2 Calibrator sample sets
3 QC samples
4 Patient samples
5 Maintenance sets
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.
Reagent Addition
When the system is ready to process a sample, the RV is moved by a robotic module 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.
In two-step assays, the RV returns to one of the reagent carriages for additional reagents, followed by another
incubation period.

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Sample Washing and Reading

When the sample incubation is complete, the RV is moved to the wash carousel to begin final processing. As
the wash carousel rotates, the RV moves through three 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.
After the luminometer reading, the RV is moved to a waste chute and discarded.
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.
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.
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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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.
Assay Characteristics
See the reagent instructions for use for each assay for information about assay characteristics including:
• Reagent composition, storage, and handling precautions
• Analytical performance
• Sample handling
• Calibrator characteristics and calibration interval
• Calibrator and control traceability
Assay Calibration Theory

The UniCel DxI system performs the following types of assay calibrations:
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.
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.

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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.
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
2239A.eps
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
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.

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UniCel DxI Instructions for Use A: Temperature-Sensitive Assays
A Temperature-Sensitive Assays
The Access assays listed in the table below are affected by changes in the room temperature of the UniCel DxI
system. The result for a given sample test may shift if the room temperature changes significantly from the
temperature at which the assay was calibrated. Depending on the assay, an increase or decrease in room
temperature causes test results to increase or decrease. The magnitude and direction of the result shift for each
assay is shown in the table.
If the change in room temperature exceeds the restricted calibration temperature range, the assay must be
recalibrated at the new temperature before samples are tested. Recalibrating these assays at the new room
temperature limits the magnitude of the shift on sample results.
For each of the affected assays, Beckman Coulter has established a restricted calibration temperature range in
which the assay should be calibrated and run. Within this range, the change in assay results due to temperature
is expected to be within the allowable performance characteristics of the assay.
Restricted
Allowable% If the temperature
calibration
Part #* Product* Change in increases, the
temperature
result assay result…
range
33000 Access Vitamin B12 ±4 °C (±7.2 °F) ±14% Increases

33210 Access AFP (100 Test Kit) ±4 °C (±7.2 °F) ±10% Increases
33211 Access AFP (300 Test Kit) ±4 °C (±7.2 °F) ±10% Increases
33410 Access Ultrasensitive Insulin ±4 °C (±7.2 °F) ±9% Increases
33540 Access Estradiol ±4 °C (±7.2 °F) ±19% Decreases
33560 Access Testosterone ±4 °C (±7.2 °F) ±9% Decreases
33580 Access Ultrasensitive hGH ±4 °C (±7.2 °F) ±10% Increases
33600 Access Cortisol ±4 °C (±7.2 °F) ±12% Decreases
33820 Access Fast TSH ±4 °C (±7.2 °F) ±9% Increases
(Test IDs 246 and 11246 only)
33880 Access Free T4 ±4 °C (±7.2 °F) ±12% Increases
34210 Access HAV IgM ±4 °C (±7.2 °F) ±10% Increases
34240 Access HBc Ab ±4 °C (±7.2 °F) ±10% Increases
34250 Access HBc IgM ±4 °C (±7.2 °F) ±15% Increases
34430 Access Rubella IgG ±4 °C (±7.2 °F) ±15% Increases
98200 Access BNP† ±4 °C (±7.2 °F) ±9% Decreases
386371 Access CK-MB ±4 °C (±7.2 °F) ±10% Increases
© 2022 Beckman Coulter, Inc. A-1

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UniCel DxI Instructions for Use A: Temperature-Sensitive Assays
Restricted
Allowable% If the temperature
* * calibration
Part # Product Change in increases, the
temperature
result assay result…
range
A12985 Access TPO Antibody ±4 °C (±7.2 °F) ±14% Increases

A13422 Access Free T3 ±4 °C (±7.2 °F) ±16% Increases
A16972 Access Intact PTH - Intraoperative ±4 °C (±7.2 °F) ±14% Increases
Mode (Test IDs 215 & 11215 only)
A31588 Access Toxo IgG ±5 °C (±9.0 °F) ±20% Increases
A36097 Access Inhibin A ±4 °C (±7.2 °F) ±10% Decreases
A40702 Access CMV IgG ±5 °C (±9.0 °F) ±15% Increases
A48617 Access SHBG ±5 °C (±9.0 °F) ±18% Increases
A49752 Access Hybritech p2PSA ±6°C (±10.8 °F) ±16.9% Decreases
B03704
* The availability of these assays in your country depends on the status of submissions to local regulatory agencies.
Contact your Beckman Coulter representative if you have questions about the availability of particular assays.
† Sale and distribution of part number 98200 have moved from Quidel Corporation to Beckman Coulter. Customers in
some countries may continue to receive product labeled as Quidel Triage BNP during a transition period. The
formulation of both products is the same.
The UniCel DxI system does not monitor the room temperature or alert the operator if room temperature
changes from the original calibration temperature for assays identified in the table. You should ensure that your
laboratory has established a procedure to monitor and review temperature during system operation. Quality
control may not detect temperature related change in assay results and cannot be used as a substitute for
temperature monitoring.
If your laboratory is unable to maintain the required temperature ranges, do not report results out of the
laboratory. Please contact Beckman Coulter for additional suggestions regarding temperature monitoring and
control.
© 2022 Beckman Coulter, Inc. A-2

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UniCel DxI Instructions for Use B: Ordering Information
B Ordering Information
Assay-Specific Reagents
The availability of these assays in your country depends on the status of submissions to local regulatory
agencies. In addition, an assay may not be available for use on all systems. Contact your Beckman Coulter
representative if you have questions about the availability of particular assays.
To obtain assay-specific reagents:

• In the U.S.A. or Canada, contact Beckman Coulter Customer Service at 1-800-526-3821.
• Outside the U.S.A. and Canada, contact your local Beckman Coulter representative.
# Tests or
Access Assay # Calibrations
Analyte Part # Description Volume*
Name (@ 500 µL/
Calibration)
Adrenal/ Pituitary
Cortisol Cortisol 33600 Reagent 2 x 50 tests 100
33605 Calibrator 6 x 4.0 mL 8
33606 Diluent (S0) 1 x 4.0 mL
Anemia
Active-B12† / Holotranscobalamin C01772 Reagent 2 x 50 tests 100
Active-B12- (holoTC); Active B12 C01773 Calibrator 6 x 2.0 mL 4
Diluted
C01774 QC 2 levels, 3.0 mL each
EPO/ Erythropoietin A16364 Reagent 2 x 50 tests 100
EPO-Diluted A16365 Calibrator 6 total; S0 @ 10 mL 5
S1–S5 @ 2.5 mL
A79783 Diluent Pack 2 x 90 tests 180
Ferritin / Ferritin 33020 Reagent 2 x 50 tests 100
Diluted Ferritin / 33025 Calibrator 6 x 4.0 mL 8
Ferritin-Diluted
Folate / Folic acid; Folate A98032 Reagent 2 x 50 tests 100
Red Blood Cell A98033 Calibrator 6 x 4.0 mL 8
(RBC) Folate /
A99250 Diluent (S0) 1 x 4.0 mL
Folate-Diluted
A14206 Lysing Agent 2 x 100 mL
Intrinsic Factor Intrinsic factor 387992 Reagent 2 x 50 tests 100
Ab blocking antibody 387993 Calibrator 1 level; 2 x 4.0 mL 16
387999 QC 2 levels; 3 x 4.0 mL each
sTfR / Soluble transferrin A32493 Reagent 2 x 50 tests 100
sTfR-Diluted receptor A32494 Calibrator 6 total; S0 @ 4 mL 5
S1–S5 @ 2.5 mL
B11056 QC1 1 level; 2 x 2.5 mL each
B11057 QC2 & QC3 2 levels; 2 x 2.5 mL each
© 2022 Beckman Coulter, Inc. B-1

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# Tests or
Name (@ 500 µL/
Calibration)
Vitamin B12 / Vitamin B12; 33000 Reagent 2 x 50 tests 100
Vitamin B12- Cobalamin 33005 Calibrator 6 x 4.0 mL 8
Diluted
33006 Diluent (S0) 1 x 4.0 mL
Blood Virus
HAV Ab† Hepatitis A virus 34200 Reagent 2 x 50 tests 100
antibody 34205 Calibrator 5 x 2.0 mL 4
HAV IgM† Hepatitis A virus IgM 34210 Reagent 2 x 50 tests 100
HBc Ab† Hepatitis B virus core 34240 Reagent 2 x 50 tests 100
HBc IgM† Hepatitis B virus core 34250 Reagent 2 x 50 tests 100
IgM antibody 34255 Calibrator 2 x 1.0 mL 2
HBs Ab† Hepatitis B virus A24296 Reagent 2 x 50 tests 100
surface antibody A24297 Calibrator 6 x 2.5 mL 5
A24298 QC 2 levels; 3 x 3.5 mL each
HBs Ag† Hepatitis B virus A24291 Reagent 2 x 50 tests 100
surface antigen A24292 Calibrator 2 x 2.7 mL 5
HBs Ag Hepatitis B virus A24295 Confirmatory 2 x 50 tests 100 (50 patient
Confirmatory† surface antigen (2 x 25 patient samples) samples)
confirmatory
HCV Ab Anti-hepatitis C virus 34330 Reagent 2 x 50 tests 100
PLUS†,** antibodies 34335 Calibrator 2 x 1.0 mL 2
34339 QC (Pos/Neg) 2 levels; 3 x 2.5 mL each
HCV Ab V3†, ** Anti-hepatitis C virus B33458 Reagent 2 x 50 tests 100
antibodies B33459 Calibrator 2 levels; 1 x 1.0 mL each 4
B33460 QC 2 levels; 2 x 3.5 mL each
HIV Combo†,** HIV p24 antigen and A59428 Reagent 2 x 50 tests 100
antibodies to A59429 Calibrator 2 x 1.7 mL 3
HIV-1/O/2 (Pos/Neg)
A59430 QC1, QC2, and 3 levels; 2 x 4.4 mL each
QC3
B22822 QC4 and QC5 2 levels; 2 x 4.4 mL each
Bone Metabolism
Intact PTH / Parathyroid A16972 Reagent 2 x 50 tests 100
Intact PTH- hormone, intact A16953 Calibrator 6 x 1.0 mL 2
Diluted (routine and A79783 Diluent Pack 2 x 60 tests 120
intraoperative)

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# Tests or
Name (@ 500 µL/
Calibration)
Ostase / Bone specific alkaline 37300 Reagent 2 x 50 tests 100
Ostase-Diluted phosphatase B83876 Calibrator 6 x 2.5 mL 5
B83877 QC 2 levels; 4.0 mL each
Ultrasensitive Growth hormone 33580 Reagent 2 x 50 tests 100
hGH / 33585 Calibrator 6 x 2.0 mL 4
Ultrasensitive
hGH-Diluted
25(OH) 25(OH) vitamin D A98856 Reagent 2 x 50 tests 100
Vitamin D Total† A98857 Calibrator 6 x 1.4 mL 2
Cardiovascular
BNP†† / B-type natriuretic 98200 Reagent 2 x 50 tests 100
BNP-Diluted peptide (BNP) 98202 Calibrator 6 x 1.5 mL 3
CK-MB / Creatine kinase, 386371 Reagent 2 x 50 tests 100
CK-MB-Diluted isoenzyme MB 386372 Calibrator 6 x 2.0 mL 4
Digoxin / Digoxin 33710 Reagent 2 x 50 tests 100
Digoxin-Diluted 33715 Calibrator 6 x 4.0 mL 8
33716 Diluent (S0) 1 x 4.0 mL
hsTnI / High sensitivity B52699 Reagent 2 x 50 tests 100
hsTnI-Diluted troponin I B52700 Calibrator 7 total; S0-S2 @ 1.5 mL 2
(Outside US only) S3-S6 @ 1.0 mL
C26909 Calibrator 7 total; S0-S2 @ 1.5 mL 2
(US only) S3-S6 @ 1.0 mL
Myoglobin / Myoglobin 973243 Reagent 2 x 50 tests 100
Myoglobin- 973244 Calibrator 6 x 1.0 mL 2
Diluted
A79783 Diluent pack 2 x 60 tests 120
Diabetes
C-Peptide / C-peptide; C33451 Reagent 2 x 50 tests 100
C-Peptide Connecting peptide C31860 Calibrator 6 x 2.0 mL 4
Onboard
A79783 Diluent pack 2 x 60 tests 120
Pre-Dilution
Ultrasensitive Insulin 33410 Reagent 2 x 50 tests 100
Insulin / 33415 Calibrator 6 x 2.0 mL 4
Ultrasensitive
Insulin-Diluted
Infectious Disease
CMV IgG† Cytomegalovirus A40702 Reagent 2 x 50 tests 100
antibody, IgG A40703 Calibrator 6 x 1.0 mL 2
CMV IgM† Cytomegalovirus A40705 Reagent 2 x 50 tests 100
antibody, IgM A40706 Calibrator 2 x 1.0 mL 2

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# Tests or
Name (@ 500 µL/
Calibration)
Rubella IgG Rubella antibody, IgG 34430 Reagent 2 x 50 tests 100
Rubella IgM† Rubella antibody, A32937 Reagent 2 x 50 tests 100
IgM 34445 Calibrator 4 x 1.0 mL 2
SARS-CoV-2 SARS-CoV-2 IgG C58961 Reagent 2 x 100 tests 200
IgG*** C58963 Calibrator 2 x 2.0 mL 4
C58964 QC (Pos/Neg) 2 levels; 3 x 4.0 mL each
SARS-CoV-2 SARS-CoV-2 IgG C69057 Reagent 2 x 100 tests 200
IgG II*** C69058 Calibrator 6 x 2.0 mL 4
C69059 QC 2 levels; 3 x 4.0 mL each
SARS-CoV-2 SARS-CoV-2 IgM C58957 Reagent 2 x 100 tests 200
IgM*** C58958 Calibrator 2 x 2.0 mL 4
C58959 QC (Pos/Neg) 2 levels; 3 x 4.0 mL each
Toxo IgG Toxoplasma gondii A31588 Reagent 2 x 50 tests 100
antibody, IgG A31589 Calibrator 6 x 1.0 mL 2
A31590 QC (Pos/Neg) 2 levels; 3 x 2.5 mL each
Toxo IgM II Toxoplasma gondii 34470 Reagent 2 x 50 tests 100
antibody, IgM 34475 Calibrator 2 x 1.5 mL 3
Inflammation
IL-6*** / Interleukin-6 A16369 Reagent 2 x 50 tests 100
IL-6-Diluted A16370 Calibrator 6 total; S0 @ 4.0 mL 5
S1–S5 @ 2.5 mL
Reproductive
AFP / Alpha-fetoprotein 33211 300 test kit 6 x 50 tests 300
Diluted AFP / (Cals included) Cals: 7 x 2.5 mL 5
AFP-Diluted
33210 100 test kit 2 x 50 tests 100
(outside US only)
33215 Calibrators 7 x 2.5 mL 5
(for 100 test kit)
33216 Diluent 1 x 14.0 mL
AMH Anti-Müllerian B13127 Reagent 2 x 50 tests 100
hormone (AMH) B13128 Calibrator 6 x 2.0 mL 4
B13129 QC 3 levels; 2 x 2 mL each
AMH Advanced† Anti-Müllerian C62997 Reagent 2 x 50 tests 100
hormone (AMH) B13128 Calibrator 6 x 2.0 mL 4
B13129 QC 3 levels; 2 x 2 mL each

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# Tests or
Name (@ 500 µL/
Calibration)
DHEA-S / Dehydroepiandro- A10826 Reagent 2 x 50 tests 100
DHEA-S-Diluted sterone sulfate A10827 Calibrator 6 x 2.0 mL 4
hFSH / Follicle stimulating 33520 Reagent 2 x 50 tests 100
hFSH-Diluted hormone 33525 Calibrator 6 x 4.0 mL 8
hLH / Luteinizing hormone 33510 Reagent 2 x 50 tests 100
hLH-Diluted 33515 Calibrator 6 x 4.0 mL 8
Inhibin A / Inhibin A A36097 Reagent 2 x 50 tests 100
Inhibin A- A36098 Calibrator 7 x 2.5 mL 5
Diluted
PAPP-A† / Pregnancy- A48571 Reagent 2 x 50 tests 100
PAPP-A-Diluted associated A48572 Calibrator 6 x 1.0 mL 2
plasma protein A
Progesterone Progesterone 33550 Reagent 2 x 50 tests 100
33555 Calibrator 6 total; S0 @ 4.0 mL 5
S1–S5 @ 2.5 mL
33556 Diluent (S0) 1 x 4.0 mL
Prolactin / Prolactin 33530 Reagent 2 x 50 tests 100
Prolactin- 33535 Calibrator 6 total; S0 @ 4.0 mL 5
Diluted S1–S5 @ 2.5 mL
Sensitive Estradiol B84493 Reagent 2 x 50 tests 100
Estradiol / B84494 Calibrator 6 total; S0 @ 4.0 mL 4
Sensitive S1-S5 @ 2.0 mL
Estradiol-
Diluted
SHBG/ Sex hormone binding A48617 Reagent 2 x 50 tests 100
SHBG-Diluted globulin A48618 Calibrator 6 x 1.0 mL 2
Testosterone Testosterone, total 33560 Reagent 2 x 50 tests 100
Total hCG (5th hCG; Beta-hCG A85264 Reagent 2 x 50 tests 100
IS) / Diluted B11754 Calibrator 6 x 4.0 mL 8
Total hCG (5th
IS) / Total hCG
(5th IS)-Diluted
Unconjugated Unconjugated estriol 33570 Reagent 2 x 50 tests 100
Estriol 33575 Calibrator 7 total; S0 @ 4.0 mL 5
S1-S6 @ 2.5 mL

C96782-AA
# Tests or
Name (@ 500 µL/
Calibration)
Sepsis
PCT / Procalcitonin C22593† Reagent 2 x 50 tests 100
PCT-Diluted (Outside US only) C22594 †
Calibrator 7 x 2.0 mL 4
Procalcitonin C53987 Reagent 2 x 50 tests 100
(US only) C53986 Calibrator 7 x 2.0 mL 4
Thyroid
Free T3 Triiodothyronine, free A13422 Reagent 2 x 50 tests 100
A13430 Calibrator 6 x 2.5 mL 5
Free T4 Thyroxine, free 33880 Reagent 2 x 50 tests 100
Thyroglobulin Thyroglobulin 33860 Reagent 2 x 50 tests 100
Thyroglobulin Thyroglobulin A32898 Reagent 2 x 50 tests 100
Antibody II antibody A36920 Calibrator 6 total; S0 @ 4.0 mL 5
S1–S5 @ 2.5 mL
Total T3 Triiodothyronine 33830 Reagent 2 x 50 tests 100
Total T4 Thyroxine 33800 Reagent 2 x 50 tests 100
Thyroid Uptake Thyroxine-binding 33810 Reagent 2 x 50 tests 100
capacity 33815 Calibrator 1 level; 6 x 1.0 mL 12
TPO Antibody/ Thyroperoxidase A12985 Reagent 2 x 50 tests 100
TPO Antibody- Antibody A18227 Calibrator 6 x 2.0 mL 4
Diluted
TSH (3rd IS) / Thyroid-stimulating B63284 Reagent 2 x 100 tests 200
Diluted TSH hormone; Thyrotropin B63285 Calibrator 6 x 2.5 mL 5
(3rd IS)
Tumor Markers
AFP / Alpha-fetoprotein 33211 300 test kit 6 x 50 tests 300
Diluted AFP/ (Cals included) Cals: 7 x 2.5 mL 5
AFP-Diluted 33210 100 test kit 2 x 50 tests 100
(outside US only)
33215 Calibrators 7 x 2.5 mL 5
(for 100 test kit)
BR Monitor / Cancer antigen 15-3 387620 Reagent 2 x 50 tests 100
BR Monitor- 387647 Calibrator 6 x 1.5 mL 3
Diluted
CEA Carcinoembryonic 33200 Reagent 2 x 50 tests 100
antigen 33205 Calibrator 6 x 2.5 mL 5

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# Tests or
Name (@ 500 µL/
Calibration)
GI Monitor / Cancer antigen 19-9 387687 Reagent 2 x 50 tests 100
GI Monitor- 387688 Calibrator 6 x 2.5 mL 5
Diluted
Hybritech PSA / Prostate-specific 37200 Reagent 2 x 50 tests 100
Hybritech PSA- antigen 37205 Calibrator 6 x 2.5 mL 5
Diluted
Hybritech free Free prostate- 37210 Reagent 2 x 50 tests 100
PSA specific antigen 37215 Calibrator 6 total; S0 @ 5.0 mL 5
S1 - S5 @ 2.5 mL
Hybritech [-2]proPSA A49752† Reagent 2 x 50 tests 100
p2PSA A49753† Calibrator 7 x 2.1 mL 4
B03704 Reagent 2 x 50 tests 100
B03705 Calibrator 7 x 2.1 mL 4
OV Monitor / Cancer antigen 125 386357 Reagent 2 x 50 tests 100
OV Monitor- 386358 Calibrator 6 x 2.5 mL 5
Diluted
Research Use Only
IL-6 (RUO) / Interleukin-6 A30945 Reagent 2 x 50 tests 100
IL-6 (RUO)- A30944 Calibrator 6 total; S0 @ 4.0 mL 5
Diluted S1–S5 @ 2.5 mL
PAPP-A (RUO) Pregnancy- A49209 Reagent 2 x 50 tests 100
/PAPP-A (RUO)- associated A49210 Calibrator 6 x 1.0 mL 2
Diluted plasma protein A
* All onboard dilution assays use diluent pack A79783 or A79784. The volume of diluent used for each test is assay
dependent. Consequently, the number of tests available per diluent pack differs by assay.
† Not available in the US.
** Distributed by Beckman Coulter for Bio-Rad for use on Beckman Coulter immunoassay systems.
†† Sale and distribution of part number 98200 have moved from Quidel Corporation to Beckman Coulter. Customers
in some countries may continue to receive product labeled as Quidel Triage BNP during a transition period. The
formulation of both products is the same.
*** In the U.S.A., this assay is for use under the Emergency Use Authorization (EUA) only.
CONDITIONS OF AUTHORIZATION FOR THE LABORATORY
The Access IL-6, Access SARS-CoV-2 IgG, Access SARS-CoV-2 IgG II, and Access SARS-COV-2 IgM assays,
along with the authorized Fact Sheet for Healthcare Providers, the authorized Fact Sheet for Patients and authorized
labeling, are available on the FDA website: https://www.fda.gov/medical-devices/emergency-situations-medical-
devices/emergency-use- authorizations#covid19ivd or at https://www.beckmancoulter.com. Authorized laboratories
using the Access IL-6, Access SARS-CoV-2 IgG, Access SARS-CoV-2 IgG II, or Access SARS-COV-2 IgM assays
must adhere to the Conditions of Authorization indicated in the Letter of Authorization.

C96782-AA
System Supplies
System supplies are organized alphabetically in two tables. The first table contains supplies ordered through
Customer Service. The second table contains supplies ordered through Customer Technical Support.
To obtain the following supplies:

• In the U.S.A. or Canada, contact Beckman Coulter Customer Service at 1-800-526-3821.
• Outside the U.S.A. and Canada, contact your local Beckman Coulter representative.
Description Part # Quantity
Citranox acid cleaner and detergent 81912 1 gallon
Contrad 70 cleaning solution 81911 1 liter
Data Storage Device:
USB Flash Drive A81923 1
Diluent Packs (For onboard dilution tests)
Sample Diluent A A79783 Box of 2 packs
Wash Buffer II A79784 Box of 2 packs
Duck Bill Check Valve (White)* A32775 10
Lubricant, Type 2 Lithium, 1 mL* 6981C† 1
Printer supplies are no longer available from Beckman Coulter, Inc. Obtain printer supplies from your local office supplier or the
printer manufacturer.
Probes/pipettors and related supplies:
Aspirate Probe Clean Kit 386191 1
Disposable Aspirate Probe Brush 386190 10
Probes identified with a colored sleeve containing a probe number
Aspirate Probe, A1W B14788 1
Aspirate Probe, A2 B14789 1
Aspirate Probe, A3 B14790 1
Dispense Probe, D1 C77145 1
Pump Tube, Aspirate Peristaltic, 1.30 mm* 77372 1
Reaction vessels (RVs), UniCel DxI 386167 Box of 10,000
Sample Diluent A, vial 81908 1 x 4.0 mL
Sample Containers:
0.5 mL Sample cups, Beckman Coulter 651412 1000
2.0 mL Sample cups, Beckman Coulter 81902/652730 1000
1.0 mL/13 mm insert cups, Beckman Coulter 81915 1000
1.0 mL/13 mm insert cup caps 81920 1000
2.0 mL/16 mm insert cups, Beckman Coulter 81917 1000
3.0 mL sample containers, Beckman Coulter 81914 500
3.0 mL sample container caps 81922A† 1000
Autoaliquot tubes (13x100 mm false bottom), Beckman Coulter 2910034 4000
Pediatric insert cups, 1.0 mL, Beckman Coulter 81916 1000
Pediatric tube adapters for 13 mm rack, Beckman Coulter 472987 100
Sample Probe A92071 1
Sample Racks and Accessories:
Sample Racks:

C96782-AA

13 x 75, Blue 471918 Pack of 10
13 x 75, Gray A25337 Pack of 10
13 x 100, Blue 471919 Pack of 10
16 x 75, Blue 471920 Pack of 10
16 x 100, Blue 471921 Pack of 10
13 x 100, Brown 471922 Pack of 10
13 x 100, Gray 473491 Pack of 10
16 x 100, Gray 473492 Pack of 10
Sample Rack Holders B06330 1 box of 4
Sample Rack ID Label kit 386180 50 labels per
container type
Sample Rack Barcode Labels
Labels 1-500 471891 1
Labels 501-999 471892 1
Solid Waste Bags, UniCel DxI C62616 1 box of 100
Substrate 81906 4 @ 130 mL
Swab applicators, fiber-free polyester 104838 100
System Check Solution 81910 6 @ 4.0 mL
Wash Buffer II, UniCel DxI A16793 1 @ 10 L
* Item is also a component of the UniCel DxI CARE Kit (Catalog # A34821)
† An item with a catalog number ending in a letter may be revised from time to time. If you have difficulty ordering
this item, ask your Beckman Coulter representative to check for a more recent revision.
To obtain the following supplies:

• In the U.S.A. or Canada, contact Beckman Coulter Technical Support by phone at 1-800-854-3633.
• Outside the U.S.A. and Canada, contact your local Technical Support representative.
CARE Kit, UniCel DxI A34821 1
Keyboard template (English) A46608 1
Liquid Waste Bottle, UniCel DxI 800 129071 1
Liquid Waste Bottle, UniCel DxI 600 A45817 1
Pipettor, Reagent, 3-inch probe* 6071 1
Tool Kit, Access Customer * 7014C† 1
* Item is also a component of the UniCel DxI CARE Kit (Catalog # A34821)
† An item with a catalog number ending in a letter may be revised from time to time. If you have difficulty ordering
this item, ask your Beckman Coulter representative to check for a more recent revision.

C96782-AA
UniCel DxI System Documentation

Manuals, instructions for use, and other supporting documents for your UniCel DxI 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.
In addition, some printed documents, listed below, are available for order from Beckman Coulter. To obtain
these documents:
• In the U.S.A. or Canada, contact Technical Support by phone at 1-800-854-3633.
• Outside the U.S.A. and Canada, contact your technical support representative.
UniCel DxI System Documentation Part # Quantity
Operator’s Guide (Paper, with binder; English) B14248 1
Reference Manual (Paper, with binder; English) B14249 1
Installation Implementation Guide; Paper, with binder 986183 1
System Maintenance and Service Log binder 986182 1
UniCel DxI Instructions for Use; Paper, with binder
Language Part # Quantity Language Part # Quantity
English B14250 1 Lithuanian B14217 1
Bulgarian C36076 1 Macedonian C48373 1
Chinese, Simplified B14227 1 Norwegian B14245 1
Chinese, Traditional C36078 1 Polish B14243 1
Croatian C36077 1 Portuguese B14237 1
Czech B14221 1 Portuguese, Brazilian B93291 1
Danish B14241 1 Romanian B79297 1
Dutch C07760 1 Russian B14215 1
Estonian C44845 1 Serbian C24345 1
French B14229 1 Slovak C48375 1
Italian B14233 1 Spanish B14231 1
German B14235 1 Swedish B14239 1
Greek B14223 1 Turkish B14247 1
Hungarian B14219 1 Ukrainian C42895 1
Japanese B14225 1 Vietnamese C22082 1
Latvian C44847 1

C96782-AA

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Instructions for Use

For In Vitro Diagnostic Use

Changes to this Revision:

This manual is intended for use with:

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

2 Shut Down and Restart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

© 2022 Beckman Coulter, Inc. i

4 Racks and Sample Containers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

5 Sample Manager . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

8 Theory of Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

A Temperature-Sensitive Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1

B Ordering Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1

© 2022 Beckman Coulter, Inc. ii

FOR PROFESSIONAL USE ONLY

Be prepared to provide your system ID.

© 2022 Beckman Coulter, Inc. 1-1

1 Touchscreen monitor 2 Keyboard 3 Mouse

© 2022 Beckman Coulter, Inc. 1-2

1 Touchscreen monitor 2 Keyboard 3 Mouse

© 2022 Beckman Coulter, Inc. 1-3

Status Indicator Lights

System Mode Description

Running The system is performing a function, such as processing samples or running a

© 2022 Beckman Coulter, Inc. 1-4

System Status Buttons

System Status Button Description Button Colors

Rack Exceptions Select to display the Exceptions Yellow

Work Pending Select to display the Work Pending Yellow

Supplies Required Select to display the Supplies Yellow

The system cannot start tests until the

© 2022 Beckman Coulter, Inc. 1-5

System Status Button Description Button Colors

Bulk Supplies Select to display the Bulk Supplies Yellow

A supply is empty or expired, or a waste

Event Log Select to display the Event Log Yellow

The system has generated a warning

© 2022 Beckman Coulter, Inc. 1-6

System Command Buttons

Main Menu Workflow

© 2022 Beckman Coulter, Inc. 1-7

Main Menu Workflow

F1 Reagent Supplies F1 Substrate

F5 QC Setup F1 Add Control

F5 Calibrator Setup F1 Add Calibrator

© 2022 Beckman Coulter, Inc. 1-8

Main Menu Workflow, continued

F1 Pipettor Matching F1 Reag. Pipettor Matching

F1 LIS F1 LIS Setup

F1 System Setup F1 System Revisions

F3 Test Panels F1 Filter

© 2022 Beckman Coulter, Inc. 1-9

Precautions and Hazards

Laser Warning Labels

Laser Warning Label Location

LASER LIGHT IS EMITTED

© 2022 Beckman Coulter, Inc. 1-10

Laser Warning Label Location

CLASS 1 LASER PRODUCT

PRODUCT COMPLIES WITH