Unicel DxI Operator's Guide

Operator's Guide
C73199-AA
March 2021
Printed in U.S.A.
© 2021 Beckman Coulter, Inc.
Beckman Coulter, Inc. • 250 S. Kraemer Blvd. • Brea, CA 92821 • U.S.A.
Publication Notes
This manual, C73199-AA, release date 2021-03, 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.
Changes to this Revision

Chapter Page Change Description
Title Page Publication Added software version 5.7.0. Updated the Revision History table.
Notes
4 Test Results 4-34 Revised the description of the GRY result flag.
Revision History:
C48057-AA, August 2020 UniCel DxI software versions 5.1, 5.2, 5.3.0, 5.3.1, 5.5.0, and 5.6.0
C38351-AB, March 2019 UniCel DxI software versions 5.1, 5.2, 5.3.0, 5.3.1, and 5.5.0
C38351, January 2019 UniCel DxI software versions 5.1, 5.2, 5.3.0, 5.3.1, and 5.5.0
C00548-AA, October 2016 UniCel DxI software versions 5.1, 5.2, 5.3.0, and 5.3.1
B13863F, March 2016 UniCel DxI software versions 5.1, 5.2, and 5.3.0
B13863E, June 2015 UniCel DxI software versions 5.1 and 5.2
B13863D, February 2015 UniCel DxI software version 5.1.
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.
Contrad is a trademark of Decon Laboratories, Inc.
Citranox is a trademark of Alconox, Inc.
Monovette is a trademark of Sarstedt A.G. & Co.
All other trademarks are the property of their respective owners.
UniCel DxI Operator's Guide Table of Contents
Table of Contents
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Preface-1
1 System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

1.1 System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1.2 Instrument Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
1.3 Software Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
2 Supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
2.1 Supply and Supply Conditions Overview . . . . . . . . . . . . . . . . . . 2-3
2.2 Substrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16
2.3 Wash Buffer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-27
2.4 Reaction Vessels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-36
2.5 Liquid Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-41
2.6 Solid Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-48
2.7 Reagent Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-53
2.8 Reagent Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-70
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Table of Contents UniCel DxI Operator's Guide
3 Sample Manager . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

3.1 Sample Manager Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
3.2 LIS Requests and Work Pending . . . . . . . . . . . . . . . . . . . . . . . 3-15
3.3 Patient Test Requests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25
3.4 Loading and Unloading Racks . . . . . . . . . . . . . . . . . . . . . . . . . 3-39
3.5 Monitoring Sample Progress . . . . . . . . . . . . . . . . . . . . . . . . . . 3-53
3.6 Editing Test Requests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-55
3.7 Patient Sample Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . 3-61
4 Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

4.1 Test Results Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
4.2 Test Result Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
4.3 Reviewing Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21
4.4 Managing Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-39
4.5 Test Result Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-50
5 Assay Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

5.1 Assay Calibration Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
5.2 Setting Up Calibrators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
5.3 Running a Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19
5.4 Reviewing Calibration Data . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-26
5.5 Troubleshooting Failed Calibrations . . . . . . . . . . . . . . . . . . . . 5-35
6 Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

6.1 Quality Control Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
6.2 Setting Up Quality Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
6.3 Running Quality Control Tests . . . . . . . . . . . . . . . . . . . . . . . . . 6-20
6.4 Reviewing Quality Control Charts and Data . . . . . . . . . . . . . . 6-28
6.5 QC Chart Comparisons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-44
6.6 Establishing QC Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-50
6.7 QC Troubleshooting Overview. . . . . . . . . . . . . . . . . . . . . . . . . 6-53
ii © 2020 Beckman Coulter, Inc.

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UniCel DxI Operator's Guide Table of Contents
7 Routine Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

7.1 Maintenance Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
7.2 Daily Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-12
7.3 Special Weekly Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 7-19
7.4 Test Interval Maintenance: 5,000 Tests . . . . . . . . . . . . . . . . . . 7-21
7.5 Test Interval Maintenance: 10,000 Tests . . . . . . . . . . . . . . . . . 7-31
7.6 Maintenance Log. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-62
A Sample Racks and Containers . . . . . . . . . . . . . . . . . . . . . . . A-1

A.1 Sample Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
A.2 Sample Containers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Index-1
© 2020 Beckman Coulter, Inc. iii

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Table of Contents UniCel DxI Operator's Guide
iv © 2020 Beckman Coulter, Inc.

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UniCel DxI Operator's Guide Preface
Preface
About This Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface-2
UniCel DxI System Documentation . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface-2
Using the Help System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface-4
Notes, Cautions, and Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface-9
Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface-9
© 2021 Beckman Coulter, Inc. Preface-1

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Preface UniCel DxI Operator's Guide
About This This UniCel DxI Operator's Guide provides the same content delivered in the Help
Manual system Operator's Procedures book, but in a manual format.
NOTE
Most screen, window and report examples in this manual are based on the
UniCel DxI 800 system, and may show up to four reagent pipettors. The
UniCel DxI 600 system has two reagent pipettors.
UniCel DxI The UniCel DxI system includes the following documentation.
System • The UniCel DxI Help system, which provides detailed operating and
Documentation reference information, linked to the system software.
• The Instructions for Use, which contains information intended to be used
after you have become familiar with the UniCel DxI system.
• The LIS Vendor Information document, which provides interface information
for your laboratory information system vendor.
• The Operator's Guide and Reference Manual, which provide the same
content delivered in the Help system Operating Procedures and Reference
Information books. These manuals are available in the English language.
Manuals, Instructions for Use, and other supporting documents for your 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 systemdocuments are released on the website,
register for the "My Technical Documents" notification tool.
Preface-2 © 2021 Beckman Coulter, Inc.

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Using the To make information easier for you to locate within a procedure or topic, UniCel DxI
Manual system documentation uses the following presentation styles.
Text Formatting
To call your attention to system software elements or indicators on the instrument, the
system documentation uses capital letters or bold type.
Example
If you are getting low on supplies, the Bulk Supplies system status button turns
yellow and the Amber status indicator on the instrument is lit. Select the Bulk
Supplies button and review the fields on the Bulk Supplies screen. If you need
more information, select the Help button.
Required and Optional Procedure Steps

Required steps in a procedure are indicated by sequentially numbered lists. The list
may be interrupted by an optional step, which is indicated by a small, unnumbered
box and the word (Optional).
Example
Both required and optional steps are illustrated below.
1. This is the first required step in a procedure.
 (Optional) This is an optional step in a procedure.
2. This is the second required step in a procedure.
Modes
The system modes in which a procedure can be performed are included in a mode
statement, located before the first step of the procedure.
Example
The mode indicators and the mode statement format are illustrated below.
System Mode: Ready Running Paused
Ready Not Ready

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The Help The UniCel DxI Help system provides context sensitive assistance for using the
System system software. In addition to the summary information included in the Instructions
for Use manual, the Help system contains expanded procedures for using the
UniCel DxI system. The Help system is available in the same languages as the system
software.
Information in the Help system is organized into main books, which are further
subdivided into books of related categories of information.
Operator's Provides the step-by-step information needed for

Procedures Book* everyday operation of the UniCel DxI system.
Reference Provides background, theory, system setup, and
Information Book* advanced maintenance information for the UniCel DxI
system.
Illustration Books Provide alphabetical access to all flowcharts, reports,
and screens that are also available in context
throughout the Help system. Simple windows that are
self-explanatory are not illustrated.
Table 1 Help System Book Descriptions

* Operator's Procedures and Reference Information can be ordered in electronic or paper manual
format as the Operator's Guide and Reference Manual, in the English language only.
Using the You can access the Help system from most screens and windows in the UniCel DxI
Help System system software. Help information is presented in Help windows in small chunks
called topics or procedures.
From any Help system topic, you can link to other topics using navigational features
such as the link buttons, linked text highlighted in green, the Button Bar, or the tabs in
the Help Topics window.
Accessing the Help System

You can access the Help system from any system software screen and from some
system software windows by selecting a Help button or [F12] Help on the keyboard.
Help
Description
Buttons
When you select the Help button from a software screen, the Help
system displays information about the screen. The Help window
includes a button at the top of the window for linking to the screen
illustration, and a column of arrow buttons on the left for linking to
related topics.
Table 2 System Software Help Button Descriptions

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Help
Description
Buttons
When you select Help F12 from a window, the Help system displays
procedural information related to the window you are in. The Help
window often includes buttons at the top of the window for linking to
the window illustration or other related topics.
Table 2 System Software Help Button Descriptions (continued)
Help windows are displayed over the system software screens and windows. Different
types of windows display different types of information in designated areas of the PC
monitor. The window placement is intended to make it possible for you to navigate
from one topic to another without losing sight of a window until you are finished
reviewing the topic.
Exiting the Help System

When you display a Help window, it remains in view until you display another
window of the same type, select anything in the system software, or exit the Help
system.
If you select anything in the system software while the Help system is available, the
Help system becomes hidden from view. When you select a Help button again, you
may see windows that were previously displayed.
You can exit the Help system by selecting Exit from the Help Button Bar.
NOTE
Select Exit only when you are completely done with the Help system. When you
select Exit, you exit the Help system and all Help windows close.
Help System Link Buttons

The Help system uses several buttons to indicate links to related information.
Illustrations of the link buttons in the Help system are presented in Table 3 :
Button Description
(Arrow button) Select to display a related topic.
(See Also button) Select to display the Topics Found window, which
contains a list of topics related to the text that you are viewing. To
view a related topic, select it and then select the Display button.
(Flowchart button) Select to display a flowchart of the procedure or
process that you are viewing.
Table 3 Help System Link Button Descriptions

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Button Description
(View Screen or View Window button) Select to display an

illustration of the screen or window associated with the Help topic.
You can then select an area of the screen or window to display its
description. The Help window for the description has no buttons. To
exit the window, select anything in the Help system.
(Show Me button) Select to display an illustration of an item referred
to in the topic, such as a report or a drawing of part of the instrument.
(Example button) Select to display an example of a concept referred

to in the topic.
(Glossary button) Select to display the definition of a glossary term.

Used only in the Glossary topic. The Help window for the glossary
term has no buttons. To exit the window, select anything in the Help
system.
Table 3 Help System Link Button Descriptions (continued)
Help Text Highlighted in Green

The UniCel DxI Help system contains numerous links within the text. Text links are
indicated by green lettering. You can select the green text to display the topic named
in the text.
Many buttons are preceded or followed by green text. You can select either the text or
the button to link to the related topic.

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Help Button Bar

The Button Bar is displayed at the top of most Help windows, immediately beneath
the Help window menu. Use the Button Bar to locate information within the Help
system, to print information, or to exit the Help system.
2167A.bmp
Help Window Menu The Help window menu contains features that can
(Do Not Use) change the appearance and performance of the Help.
Beckman Coulter has optimized the Help system for
your use. Do not use the Help window menu.
Find (Button) Displays the Find view of the Help Topics
window, which you can use to search a database for a
word. For more information, see the Help Find Feature
topic.
Help Topics (Button) Displays the Contents view of the Help Topics
window. For more information, see the Help Topics
Window topic.
Back (Button) Select to return to the last displayed topic in the
same window position on the PC monitor.
This button is only available if a topic was previously
displayed in the same window position.
Print (Button) Select to print the displayed topic.
Glossary (Button) Select to display the Help system glossary.
This button is available only in some Help windows.
Exit (Button) Select to exit the Help system.
Figure 4 Help Button Bar Descriptions

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Help Topics Window

To display the Help Topics window, select Help Topics from the Button Bar of most
Help windows. The Help Topics window contains three tabs for navigating through
the Help system.
2168A.bmp
Contents (Tab) Select to display the table of contents for the Help
system. From the table of contents, you can:
• Select a topic page (the white icon with a ? symbol
inside) to display the Help about the topic.
• Select a book to list more available Help topic pages and
books related to this book.
Index (Tab) Select to locate information by typing the first few
letters of a word, and then by selecting one of the available
topics.
Find (Tab) Select to search a database for a word. For more
information, see the Help Find Feature topic.
Figure 5 Help Topics Window (Contents View) Descriptions
Help Find Feature

You can use the Find feature to locate a word, phrase, or topic title anywhere in the
Help system. To access the feature, select Find on the Help Button Bar or select the
Find tab in the Help Topics window.

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The first time you use the Find feature, the Find Setup Wizard window is displayed to
assist you in setting up the search database. Select from the following options.
• Minimize database size - The search results in a list of the main topics
containing the word you entered. Beckman Coulter recommends that you
select this option.
• Maximize search capabilities - The search results in a list of every topic
containing the word you entered. It may take longer to get the results of the
search than if you selected to minimize the database size.
• Customize search capabilities - You select the characteristics of the search
in response to questions provided by the Find Setup Wizard.
After you select a database option, select Next and then select Finish. The Help
system creates the database and displays the Find window.
Notes, System documentation uses notes, cautions, and warnings to draw your attention to
Cautions, and important information, instrument operation instructions, and safety information.
Warnings
Graphic and Text Description
Notes highlight or provide additional information.

NOTE
Cautions emphasize the possibility of damage to the

CAUTION instrument.
Warnings emphasize the possibility of harm to a

WARNING person, either to the operator or to a patient because of
the possibility of erroneous results.
Table 6 Notes, Cautions, and Warnings
Technical For technical assistance with the UniCel DxI Access Immunoassay System:
Support • In the U.S.A. or Canada, contact Beckman Coulter Technical Support by
phone at 1-800-854-3633 or online at www.beckmancoulter.com. Before
using online support the first time, you will need to register online.
• Outside the U.S.A. and Canada, contact your technical support
representative.
NOTE
Be prepared to provide your system ID.

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UniCel DxI Operator's Guide 1: System Overview
1 System Overview
1.1 System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
1.2 Instrument Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Status Indicator Lights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Warranty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Safety Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Safety Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Laser Warning Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Safety Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
Regulatory Symbols and Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
Other Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
1.3 Software Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14
Running Other Applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Screens and Windows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
System Navigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Main Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
Main Menu Workflow . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
Common Screen Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22
Common Window Elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-30
Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-31
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1: System Overview UniCel DxI Operator's Guide
1.1 System Overview
The UniCel DxI Access Immunoassay System is an automated instrument that

performs a wide variety of immunoassays on patient samples. The UniCel DxI system
is a member of the family of Access Immunoassay Systems, and uses the same
reagents and methods to process samples.
The UniCel DxI system provides continuous, random access processing. While the
system is running tests, you can load routine or STAT samples, replenish supplies,
and change waste containers.
The system processes patient, quality control, and calibration samples in individual,
disposable plastic reaction vessels (RVs), using reagents from up to 50 on-board
reagent packs.
The system schedules tests as defined by the assay protocol file (APF) for each assay.
If there are not enough supplies to complete a test, system indicators inform you, so
you can attend to the supply condition and the test can be scheduled. With a large
sample storage area, a large capacity for on-board supplies, and multiple independent
reagent pipettors, the system schedules sample processing for optimum performance,
to produce up to 400 test results per hour on the UniCel DxI 800 instrument, and up to
200 test results per hour on the UniCel DxI 600 instrument.
For more information about the UniCel DxI system, instrument, and assay
technology, see Chapter 1: System Technology in the Reference Manual.
1-2 © 2021 Beckman Coulter, Inc.

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UniCel DxI Operator's Guide 1.2: Instrument Overview
1.2 Instrument Overview
The UniCel DxI system consists of two major subsystems: the instrument, which
performs all sample processing functions, and the system console, which is the human
interface to the instrument software and consists of the external computer (PC),
touchscreen monitor, keyboard, mouse, printer, and PC bar code reader.
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3
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11
4
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12
6
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14
15
17 16
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 area
11 System status panel 12 STAT/Routine buttons
13 Substrate bar code reader 14 Lower right door and instrument power
switch (behind door)
15 Wash buffer supply drawer 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
Figure 1-1 UniCel DxI 800 Instrument and System Console

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1.2: Instrument Overview UniCel DxI Operator's Guide
19 7
1
18 8
2
3
9 10
4
17 5
11
6
12
13
14
16 15
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 area
11 STAT/Routine buttons 12 Substrate bar code reader
13 Lower right door and instrument power 14 Wash buffer supply drawer
switch (behind door)
15 Solid waste door 16 Liquid waste drawer (optional)
17 Sample presentation unit (SPU) 18 Vessel hopper door
19 Left main upper cover
Figure 1-2 UniCel DxI 600 Instrument and System Console

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There are several points of operator interaction:

• Touchscreen Monitor - The touchscreen monitor displays the screens and
windows of the user interface software. The monitor is touch-sensitive,
allowing you to make selections by touching areas of the screen with the tip
of your finger or fingernail.
• Keyboard - The keyboard is used for entering data in fields on screens and in
windows. The keyboard also includes function keys which can be used in
place of the touchscreen to navigate the system. For more information, see
the Keyboard Equivalents topic in Section 1.3: Software Overview.
• Mouse - The mouse is a selection device that can be used as an alternative to
touching areas of the touchscreen monitor. You can point the cursor and click
the left mouse button to make selections.
• PC Bar Code Reader - The PC bar code reader is used for scanning bar
codes while setting up calibrators.
• Printer - The laser printer is used for printing system reports, screens,
windows, and topics from the Help.
• External Computer (PC) - The external computer controls the user interface
(UI) and maintains the system databases.
• Status Indicator Lights - Four status indicator lights can be seen from a
distance, and inform you of the general operational status of the instrument:
Ready, Running, Not Ready, or Supply Wait. For more information, see the
Status Indicator Lights topic.
• Reagent Load/Unload Area - The reagent load/unload area of the
UniCel DxI 800 instrument accepts up to four reagent packs being loaded in
the refrigerated reagent storage chamber, and returns packs to be unloaded
(the reagent load/unload area of the UniCel DxI 600 instrument handles two
reagent packs at a time). The reagent load/unload area also has room to store
bottles of substrate for equilibration to operating temperature. For more
information, see Section 2.7: Reagent Supplies.
• System Status Panel (UniCel DxI 800 instrument only) - The system status
panel shows the current supply status with icons that indicate when supplies
are low or empty, when waste containers are full, or when information on the
system console requires your attention. For more information, see the
Monitoring Supply Status topic in Section 2.1: Supply and Supply
Conditions Overview.
• STAT/Routine buttons - The STAT or Routine buttons are used to add racks
to the sample presentation unit (SPU) while the instrument is running. The
instrument finishes aliquoting samples from the rack in the sample aliquot
station and then unlocks the SPU cover. If the STAT button is pressed, a rack
can be placed in front of the other racks in the onload area. If the Routine
button is pressed, a rack can be added behind the other racks in the onload
area. For more information, see Section 3.4: Loading and Unloading Racks.

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• Substrate Bar Code Reader - The substrate bar code reader is used to scan
the bar code labels on substrate bottles after you load them on the instrument.
For more information, see the Scanning the Substrate Bar Code Label topic
in Section 2.2: Substrate.
• Lower right door and instrument power switch - The instrument power
switch and the air filter are located behind the lower right door.
• Substrate Load Area - The substrate load area holds two bottles of
chemiluminescent substrate. You can replace an empty bottle while the
instrument continues processing with the other bottle. For more information,
see Section 2.2: Substrate.
• Wash Buffer Supply Drawer - The wash buffer supply drawer holds two
bulk wash buffer containers. You can replace a bulk wash buffer container
that is empty while the instrument continues processing with the second
container. For more information, see Section 2.3: Wash Buffer.
• Solid Waste Door - The solid waste door provides access to the solid waste
container. You empty the solid waste container while the instrument
continues processing in-progress tests. The instrument will temporarily
suspend disposal of waste products, and will not start any new tests until the
container is replaced. For more information, see Section 2.6: Solid Waste.
• Liquid Waste Drawer - If your DxI system does not use an external liquid
waste drain, the liquid waste drawer holds two reusable containers for liquid
waste produced during processing. You can empty a bulk liquid waste
container that is full while the instrument continues processing with the
second container. For more information, see Section 2.5: Liquid Waste.
• Sample Presentation Unit - The sample presentation unit (SPU) receives
sample racks loaded by an operator and moves them from the onload area to
the sample aliquot station for aliquoting. When sufficient sample volume is
aliquoted for all scheduled tests, the SPU moves the sample racks to the
offload area. For more information, see Section 3.4: Loading and Unloading
Racks.
• Side Offload Area - The side offload area receives racks from the SPU so
they can be removed while the instrument is running. For more information,
see Section 3.4: Loading and Unloading Racks.
• Vessel Hopper - The vessel hopper receives RVs loaded by an operator,
automatically orients them properly, and dispenses them to the internal
processing areas of the instrument. For more information, see
Section 2.4: Reaction Vessels.
• Left and Right Main Upper Covers - The left and right main upper covers
provide access to the mechanisms inside the instrument, for preventive
maintenance. For more information, see Chapter 7: Routine Maintenance.

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Status The four status indicator lights are arranged vertically on the front panel of the
Indicator instrument. The Red, Green, and Blue indicator lights designate a specific instrument
Lights operating mode. The Amber indicator light informs you when a supply level requires
your attention.
2091A.eps
1 Red: Not ready. For more information, see the Red Status Indicator
Light topic.
2 Amber: Supplies required. For more information, see the Amber Status
Indicator Light Topic.
3 Green: Running. For more information, see the Green Status Indicator
Light topic.
4 Blue: Ready. For more information, see the Blue Status Indicator Light
topic.
Figure 1-3 Status Indicator Light Descriptions
Red Status Indicator Light

The Red status indicator light blinks when the system is not ready to process samples
due to one of the following conditions:
• System initialization is in progress. The system is initialized when it is
powered on, and when requested to do so by the operator. For more
information, see Section 4.2: Initialize System in the Reference Manual. Also
see Section 6.3: Shut Down and Restart Procedures in the Reference Manual.
• The operator has selected the Stop button on a screen in the system software.
All processing is stopped, and all tests in progress are cancelled. For more
information, see the System Command Buttons topic in Section 1.3: Software
Overview.
• A system failure has occurred. All processing is stopped, and all tests in
progress are cancelled.
The system console displays the Not Ready system mode. For more information, see
the System Modes topic in Section 1.3: Software Overview.

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Amber Status Indicator Light

The Amber status indicator light informs you when a supply level requires your
attention. The light does not indicate a change in the operating status of the
instrument. If the Amber indicator light is lit, a system status panel icon and a system
status button will also be lit. A solid or blinking amber light may be lit simultaneously
with any of the other three indicator lights.
Indicator State Description
Off The supply levels are sufficient.

Lit - One or more system supplies are low or the waste
Solid light containers are almost full. The system continues to
process tests and schedule new tests.
Lit - System supplies are out, or an area requires
Blinking light attention. The system attempts to complete any tests
in progress, but does not schedule new tests.
Table 1-4 Amber Indicator Light Descriptions
Green Status Indicator Light

The Green status indicator light is lit when the instrument is processing tests or
performing a maintenance routine. The system console displays the Running system
mode. For more information, see the System Modes topic in Section 1.3: Software
Overview.
Blue Status Indicator Light

The Blue status indicator light is lit when the instrument is idle, and ready to begin
processing. SPU operations such as aliquoting of samples can take place while in the
Ready mode. The system console displays the Ready system mode. For more
information, see the System Modes topic in Section 1.3: Software Overview.
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.

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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. For more information, see Chapter 7: Routine Maintenance.
Safety The UniCel DxI Access Immunoassay System is designed to meet U.S. and
Features 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 Certain areas of the UniCel DxI instrument present a risk of personal injury or
Symbols 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.
2208A.eps
Figure 1-5 Laser Symbol
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.

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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 Placement

For the approximate placement of laser warning labels on the UniCel DxI system,
see Figure 1-6 and Figure 1-7.
2368A.eps
1 This label is attached to the SPU bar code reader and the reagent storage
bar code reader.
LASER LIGHT IS EMITTED

AVOID EXPOSURE 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
2369A.eps
Figure 1-6 Laser Warning Label Placement Behind the UniCel DxI Sample
Processing Unit (SPU)

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2 These labels are attached to the housing that shields the reagent storage
bar code reader.
2370A.eps
&
2371A.eps
Figure 1-6 Laser Warning Label Placement Behind the UniCel DxI Sample
Processing Unit (SPU)
2372A.eps
CLASS 1 LASER PRODUCT
2373A.eps
Figure 1-7 Laser Warning Label Placement on the Back of the UniCel DxI
Instrument

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2
PRODUCT COMPLIES WITH
21 CFR CHAPTER 1, SUBCHAPTER J
Beckman Coulter, Inc. MADE IN U.S.A. MARCA REG

%
2374A.eps
Figure 1-7 Laser Warning Label Placement on the Back of the UniCel DxI
Instrument
Safety The following statements describe general safety concerns and provide information
Statements about attention symbols with no accompanying text.
WARNINGS
• The UniCel DxI instrument has moving parts which 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 top cover closed to avoid spillage into
the instrument.

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Regulatory The UniCel DxI Access Immunoassay System meets the requirements of a variety of
Symbols and domestic and international regulatory agencies, standards, and directives. This
Statements 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.
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 DxI system.
- 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.
Other In addition to safety and regulatory symbols, other symbols are placed on the
Symbols 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.

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1.3: Software Overview UniCel DxI Operator's Guide
1.3 Software Overview
The UniCel DxI system software consists of a real-time operating system in the
instrument and a PC-based user interface (UI). The instrument software controls all of
the processing functions. The UI software allows you to interact with and direct the
instrument software. It also contains sample, calibration, and quality control
databases, as well as the assay protocol file (APF). The APF contains assay-specific
information about sample processing and test result calculations. The UI software is
located on the hard drive of the external computer (PC). The instrument software, UI
software, and APF are installed on the system through the CD-ROM drive on the PC.
NOTE
Your ability to perform a function can depend on the system mode. For example,
it is not possible to delete test results or perform a system backup when the
instrument is in the Running mode. For more information about system modes,
see Table 1-13.
The system also includes a laboratory information system (LIS) interface, which an
external LIS can use to communicate with the instrument through a standard EIA-232
serial connection. Test requests entered at the LIS are transmitted to the instrument for
processing. Once processing is complete, the test results are sent back to the LIS. For
more information about the LIS interface, see Chapter 1: System Technology in the
Reference Manual. For technical information about the LIS interface, see the LIS
Vendor Information CD. For information about the processing of LIS test requests,
see Section 3.2: LIS Requests and Work Pending.

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UniCel DxI Operator's Guide 1.3: Software Overview
Running Only the UniCel DxI system software should be installed on the external computer.
Other Do not install or remove any software except as directed by a Beckman Coulter
Applications technical support representative.
Do not use the external computer to view documentation other than the system Help.
Screens and The UI is organized by function into a set of screens that have common elements.
Windows From any screen, you can pause or stop the instrument, monitor the system mode,
open the Help system, view the Event Log, select a function or an option to operate
the system, or go to another screen.
The system will sometimes display a smaller window on top of a screen to prompt
you to perform an action, confirm that you want the system to perform an action,
display a message, or allow you to enter information.
System The UniCel DxI system provides three navigation methods that you can use in any
Navigation combination to select an item on a screen or in a window:
• Touching a part of the screen using the tip of your finger or fingernail
• Using the mouse to point the cursor and clicking the left mouse button to
select an item
• Pressing a keyboard equivalent such as a function key or the tab key
Keyboard Equivalents
The following table lists the equivalent keystrokes you can use to perform common
functions on the UniCel DxI system.
Action Keyboard Equivalent
Perform the indicated function or [F1] - [F8]

display the indicated screen
Go to the Main Menu [F9]
Display the Supplies Required screen [F10]
Resume sample processing [F11]
Display the Help system [F12]
Go back to the previous screen [Esc]
Display a list in a field [Down Arrow]
Pause the system [Pause]
Table 1-8 Keyboard Equivalents

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Action Keyboard Equivalent
Stop the system [Shift]-[Pause]

Print a screen or window [Print Screen]
Display the Event Log [Scroll Lock]
Table 1-8 Keyboard Equivalents (continued)
Select and Enter

The word select is used throughout the system documentation to signify using any of
the three navigation methods to move through the screens, or to make system choices.
The word enter is used throughout the system documentation to signify putting
information into a field. Depending on the options available for the field, you can
enter information using one of the following methods:
• Type the information on the keyboard
• Select from available options or items in a list
• Scan bar coded information with the handheld bar code reader
Main Menu The Main Menu is the first screen displayed when the system is installed or
initialized. To get to this menu from any screen, press [F9] Main Menu on the
keyboard.
You can navigate almost everywhere through the UniCel DxI user interface beginning
from the eight function buttons across the bottom of the Main Menu. These buttons
are direct routes to functions you perform frequently.
The Main Menu function buttons are available from other screens when you use the
Menu tab. The Menu tab is displayed along the right edge of every screen except the
Main Menu.

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2001C.bmp
Sample Manager Select to display the Sample Manager screen. Use this screen to:
F1 • View sample status information on one of four screen views
• Request new tests for QC and patient, calibration, or maintenance
samples
• Edit the test requests on a rack
• Display specific details for a selected rack or sample
For more information, see Chapter 3: Sample Manager.
Figure 1-9 Main Menu Descriptions

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Test Results Select to display the Test Results screen. Use this screen to:
F2 • View or print test results
• Troubleshoot flagged test results
• Send test results to the LIS
• Copy test results to a disk
• Delete test results
For more information, see Chapter 4: Test Results.
Supplies Select to display the Supplies menu. Use this menu to:
F3 • View the status of system supplies and waste containers, or change the
in-use containers
• View details about on-board reagent packs and to unload reagent packs
For more information, see Chapter 2: Supplies.
Quality Control Select to display the Quality Control screen. Use this screen to:
F4 • Set up quality controls
• View the chart and data for a selected quality control, or compare the
charts for two or three quality controls
• Print a QC Review report
For more information, see Chapter 6: Quality Control.
Calibration Select to display the Calibration screen. Use this screen to:
F5 • Add, edit, and delete calibrators
• View calibration data
• Print calibration reports
For more information, see Chapter 5: Assay Calibration.
Maintenance Review Select to display the Maintenance Review screen. Use this screen to:
F6 • Review system temperatures
• Decontaminate substrate
• Run, enable, or disable the Utility routine
• Review system check results
For more information, see Chapter 7: Routine Maintenance.
Figure 1-9 Main Menu Descriptions (continued)

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Diagnostics Select to display the Diagnostics menu. Use this menu to:
F7 • Initialize the system
• Prime the fluidic system
• View information about or calibrate various instrument sensors
• Perform diagnostic or troubleshooting procedures as instructed in
system documentation or by Technical Support
For more information, see Chapter 4: Diagnostics in the Reference
Manual.
Configure Select to display the Configure menu. Use this menu to:
F8 • Set up the system
• Set up tests and results
• Display configuration information about the system
• Perform administrative tasks, such as backing up data and shutting
down the system
For more information, see Chapter 2: System Administration and see
Chapter 3: Configuring Tests and Results in the Reference Manual.
Figure 1-9 Main Menu Descriptions (continued)
Main Menu Select one of the Main Menu function buttons to display an associated screen or
Workflow 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.
For an illustration of the workflow for each of the Main Menu function buttons, see
Figure 1-10.

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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
Figure 1-10 Main Menu Workflow, Page 1 of 2

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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
Figure 1-11 Main Menu Workflow, Page 2 of 2

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Common The UniCel DxI system displays certain elements on every screen so you can
Screen continuously monitor the system status. The labels in the example screen are
Elements described in the topics that follow.
2197B.bmp
1 System mode
2 System status buttons
3 Help button
4 Scroll bar (not displayed on all screens)
5 Back tab (not displayed on the Main Menu)
6 Menu tab (not displayed on the Main Menu)
7 Function buttons
8 Status line
9 System command buttons
Figure 1-12 Common Screen Elements

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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.
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.
Table 1-13 System Mode Descriptions
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
Description Button Colors
Button
Rack Exceptions Select to display the Exceptions view of Yellow

the Sample Manager screen. For more One or more sample containers has an
information, see the Sample Manager error associated with it. For more
Screen Views topic in Section 3.1: information, see Section 3.7: Patient
Sample Manager Overview. Sample Troubleshooting.
2233A.bmp
Table 1-14 System Status Buttons

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System Status
Button
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. For more information,
see Chapter 3: Sample Manager.
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Supplies Required Select to display the Supplies Required Yellow

screen for information about needed The system requires supplies or
supplies or calibrations. For more calibration to complete the requested
information, see Chapter 2: Supplies. tests.
Red
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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.
Bulk Supplies Select to display the Bulk Supplies Yellow

screen for information on the available A supply is low or near expiration, or a
quantities of substrate, wash buffer and waste container is nearly full. The
RVs, and the available space in the needle on the gauge is displayed near
solid waste container and in the bulk the left end of the scale.
liquid waste container. For more Red
2007A.bmp
information, see Chapter 2: Supplies. 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.
Table 1-14 System Status Buttons (continued)

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System Status
Button
Quality Control Select to display the Quality Control Red

screen to setup quality controls, or A quality control result is not within the
review quality control results. For more acceptable range of expected values.
information, see Chapter 6: Quality
Control.
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Event Log Select to display the Event Log screen Yellow

for information about events generated The system has generated a caution
by the system. From this screen you can event indicating a condition that
display troubleshooting information requires your attention soon.
about caution or warning events. For Red
more information, see Chapter 5: Event The system has generated a warning
2012A.bmp
Log in the Reference Manual. event, indicating that a serious fault or
error condition exists.
Table 1-14 System Status Buttons (continued)
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. For more information, see Chapter 2:
Supplies.
2011A.bmp
Figure 1-15 Help Button

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Scroll Bar
The scroll bar is displayed along the right side or bottom of some screens. Use the
scroll bar to view content that is out of the viewing area of the screen. Select the arrow
buttons at either end of the scroll bar to move through the screen incrementally, or
drag the scroll box inside the scroll bar to move through the screen rapidly.
2190A.bmp
Figure 1-16 Scroll Bar
Back Tab
The Back tab is displayed on all screens except the Main Menu. Select the Back tab
to display the previous screen.
0649A.bmp
Figure 1-17 Back Tab
Menu Tab
The Menu tab is displayed on all screens except the Main Menu. Select the Menu tab
to display the Main Menu function buttons.
0650A.bmp
Figure 1-18 Menu Tab

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System Command Buttons

You use the three system command buttons to stop, pause, or resume processing.
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.
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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.
2137A.bmp
Resume Select to resume processing when the system is in the

Paused mode.
2138A.bmp
Table 1-19 System Command Button Descriptions
Function Buttons
The system displays a row of eight function buttons across the bottom of each screen.
Select a function button or press the corresponding function key to perform an action
or to display a menu of additional function buttons.
Function buttons vary from screen to screen, according to the operations you can
perform on each screen.
Function Button Description
A function button is available when the text is colored

black. Select the button to perform the indicated
function.
0816A.bmp
A function button is not available when the text is

colored gray. If you select a button that is not
available, the system does not respond.
0817A.bmp
Table 1-20 Function Button Examples

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Function Button Description
A button without a label is not a function button. If you

select it, the system does not respond.
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A function button with a small arrow has an associated

menu. Select the button to display the menu with
additional function buttons.
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Table 1-20 Function Button Examples (continued)
Information Fields
Three types of information fields may be displayed on screens and windows:
• Data entry fields, in which you can enter or edit pertinent information
NOTE
Do not enter a quotation mark (") in an available field. Although some fields may
accept quotation marks, characters to the right of the quotation mark may not
print on reports.
• Display fields, which display information, but cannot be edited

• List fields, which provide a list of selections
Data Entry Field When a field has a white background, you can
enter or change information in the field.
0814A.bmp
Display Field A field is not available when its background color

is the same color as the screen (beige).
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Table 1-21 Information Field Examples

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List Field A field with a down arrow on the right has a list
of several options for you to select from. Only
selections from the list can be entered in the field.
2234A.bmp
Table 1-21 Information Field Examples (continued)
Copy and Paste

The UI supports standard copy and paste functions from the keyboard. To copy data
from one field on a screen or window to another field, or to a field on another screen
or window, do the following:
1. Select the text to copy.
2. Press [Ctrl+C] (press and hold the [Ctrl] key while you press the C key).
3. Select the field into which you intend to place the text.
4. Press [Ctrl+V] (press and hold the [Ctrl] key while you press the V key).
Status Line
The status line displays the instrument ID, the software version number, the date, and
the time. Depending on the operation being performed, the status line may also
display other information pertinent to that operation.
Filters and Sort Order

Filters are tools that you use to change the organization or quantity of data displayed
on a screen. You can apply filters to screens such as the Test Results screen, which
accumulate data over time, so that only certain types of data, or results from a certain
date range, are displayed. Filters also allow you to change the sorting parameters so
that data can be sorted by different fields such as patient ID or test name. Many filters
have a first and second sort order, and permit you to sort fields in ascending or
descending order. Some filters can be customized, allowing you to create and save
specialized sets of parameters for later use.
Because the filters for each screen are different, a separate procedure is provided for
applying each filter.

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Common The UniCel DxI system windows provide information, or prompt you to enter
Window information, to perform an action, or to confirm that you want the system to perform
Elements an action. Illustrations of many windows are included in the system documentation.
2209B.bmp
Op
Options Options are exclusive selections. Only one option in a

group can be selected at a time. When you select an
option, the previously selected option is cleared.
Boxes Boxes are aggregate selections. Any number of boxes
can be selected at the same time.
OK Select to:
F1 • Save and apply changes and exit the window
or • Confirm that you want an action to be performed
Done • Exit a window
F1
Cancel Select to exit a window without performing the task.
F8 If you have changed selections in the window, the
changes are not saved or applied.
Help Select to:
F12 • Display procedural information about using the
window
• Navigate from the procedure to any other topic in
the Help
Table 1-22 Options, Boxes, and Common Button Examples

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Options and Boxes

Many screens and windows include settings that you can change by touching the
screen or by clicking the mouse. These parameters fall into two types: options and
boxes.
Options are round white buttons, and contain a black dot when selected. When an
option is the same color as the window background, it is not available.
Boxes are white squares, and contain a check mark when selected. When a box is the
same color as the window background, it is not available.
Common Buttons
The OK F1, Done F1, Cancel F8, and Help F12 buttons are common buttons and
appear in many different windows.
Reports You can print reports as well as the displayed screen or window from the UniCel DxI
system software.
The system provides the following reports:

• Alignment and Configuration Report
• Calibration Reports
• Continuous Sample Report
• Dark Count Report
• Derived Result Range Reports (Reference, Critical, and LIS Ranges)
• Derived Results Setup Report
• Event Log Report
• Patient Report
• Pipettor Matching Reports
• QC Reports
• Reagent Inventory Report
• Reagent Supplies Report
• Reflex Tests Setup Report
• RF Level Sense Report
• Sample Report
• Selected Test Result Report

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• Supplies Required Report

• System Check Report
• Temperature Report
• Test Panels Setup Report
• Test Result Range Reports (Reference, Critical, and LIS Ranges)
• Tests Setup Report
• Ultrasonic Level Sense Test Report
• Work Pending Report
Headers and Standard Text

The system prints the same information at the top and bottom of all reports. The first
page of every report contains a complete header, and subsequent pages of the report
contain an abbreviated header.
NOTE
If information about a sample or patient continues onto another page, the system
repeats the sample or patient ID at the top of that page.
Report header information is set up when you configure your system. For more
information, see Section 2.2: System Setup in the Reference Manual.

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4 5
3 Laboratories, Inc.
Laboratory A
6
Report Name
123 Lake Street
Townsville, ST 3333
7
UniCel DxI 800, Access Immunoassay System 101-555-2323 ext. 109 8
S/N 654321, Version 4.4 Jane Smith
1 2
9
10
QNS = sample quantity not sufficient, ORL = result below reference range, ORH = result above reference range,
LEX = reagent pack lot expired
11
13 12
Page 1 of 1
Technologist Printed 02/03/11 02:43 PM
3006B.eps
1 Instrument serial number (S/N), software version number

2 Product name (UniCel DxI (800 or 600), Access Immunoassay System)
3 Report name
4 Institution
5 Laboratory name
6 Laboratory street address
7 Laboratory city, state, zip code
8 Laboratory telephone number
9 Laboratory director
10 Flag list (applies to reports that contain result flags)
11 Current page number and total number of pages
12 Date and time of printing
13 Technologist signature line
Figure 1-23 Report Header and Standard Text

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UniCel DxI Operator's Guide 2: Supplies
2 Supplies
2.1 Supply and Supply Conditions Overview . . . . . . . . . . . . . . . . . . . . 2-3
Monitoring Supply Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-4
Bulk Supplies Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Supplies Required Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-11
Overriding Supply Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
Resolving Supplies Required Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-14
Printing the Supplies Required Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-15
2.2 Substrate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16
Monitoring the Substrate Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17
Changing an Empty or Expired Substrate Bottle . . . . . . . . . . . . . . . . . . . . . . 2-18
Scanning the Substrate Bar Code Label. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24
Resolving Substrate Bar Code Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25
Changing an In-Use Substrate Bottle. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-26
2.3 Wash Buffer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-27
Monitoring the Wash Buffer Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-28
Changing an Empty Bulk Wash Buffer Container. . . . . . . . . . . . . . . . . . . . . 2-29
Changing an In-Use Bulk Wash Buffer Container . . . . . . . . . . . . . . . . . . . . 2-35
2.4 Reaction Vessels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-36
Monitoring the RV Supply. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-37
Adding RVs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-38

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2: Supplies UniCel DxI Operator's Guide
2.5 Liquid Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-41
Monitoring the Liquid Waste Supply. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-42
Changing a Full Bulk Liquid Waste Container . . . . . . . . . . . . . . . . . . . . . . . 2-43
Changing an In-Use Bulk Liquid Waste Container . . . . . . . . . . . . . . . . . . . . 2-47
2.6 Solid Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-48
Monitoring the Solid Waste Supply. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-49
Changing a Full Solid Waste Container. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-50
2.7 Reagent Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-53
Monitoring the Reagent Pack Supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-54
Reagent Supplies Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-55
Displaying and Printing Reagent Pack Details . . . . . . . . . . . . . . . . . . . . . . . 2-58
Loading a Reagent Pack. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-60
Unloading a Reagent Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-65
Unloading All Reagent Packs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-67
2.8 Reagent Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-70
Reagent Inventory Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-71
Applying a Filter to the Reagent Inventory Screen . . . . . . . . . . . . . . . . . . . . 2-73
Deleting a Reagent Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-75
Printing the Reagent Inventory Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-77

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UniCel DxI Operator's Guide 2.1: Supply and Supply Conditions Overview
2.1 Supply and Supply Conditions

Overview
The UniCel DxI system uses reagent and bulk supplies to process samples. Reagent
supplies are the on-board reagent packs. Bulk supplies are the supplies the system
consumes and the waste it generates during processing. There are three consumable
bulk supplies:
• Substrate
• Wash buffer
• Reaction vessels (RVs)
There are two different types of bulk waste:

• Liquid waste
• Solid waste
The system uses a liquid waste drain (or optional on-board bulk liquid waste
containers) and a solid waste container to collect the waste generated during sample
processing. To prevent interruptions for needed supplies, monitor the status indicators
and respond by adding or changing supplies promptly. For more information, see the
Monitoring Supply Status topic.
Several status indicators inform you when a bulk supply condition occurs, or if a
reagent pack or calibration are required to continue processing tests. If a supply is
required, the system processes as many tests as possible, but does not schedule
additional tests. You can override expired supply or calibration conditions to continue
processing tests.
For information about ordering supplies, see the Instructions for Use manual.

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2.1: Supply and Supply Conditions Overview UniCel DxI Operator's Guide
Monitoring The system displays and continuously updates its supply and operating status during
Supply Status processing. Three different system indicators present the supply information:
• The Amber status indicator light
• The system status panel (UniCel DxI 800 instrument only)
• The Bulk Supplies and Supplies Required system status buttons
Amber Status Indicator Light

There are four status indicator lights located on the right main upper cover (see
Figure 1-1 in Section 1.2: Instrument Overview). The Amber status indicator light
informs you when a supply level requires your attention. The light does not indicate a
change in the operating status of the instrument. If the Amber indicator light is lit, a
system status panel icon and a system status button will also be lit. A solid or blinking
amber light may be lit simultaneously with any of the other three indicator lights.
Indicator State Description

Off The supply levels are sufficient.
Lit - One or more system supplies are low or the waste
Solid light containers are almost full. The system continues to process
tests and schedule new tests.
Lit - System supplies are out, or an area requires attention. The
Blinking light system attempts to complete any tests in progress, but does
not schedule new tests.
Table 2-1 Amber Indicator Light Descriptions
System Status Panel (DxI 800 Only)

The UniCel DxI 800 instrument has a system status panel located on the horizontal
panel directly below the status indicator lights (see Figure 1-1 in Section 1.2:
Instrument Overview). 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 a 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

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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
Figure 2-2 UniCel DxI 800 System Status Panel Icons
System Status Buttons

There are six system status buttons that display across the top of each UniCel DxI
system screen. Two of the buttons indicate supply status:
• The Bulk Supplies button indicates the substrate, wash buffer, RV, and
liquid and solid waste supply status.
• The Supplies Required button indicates the status of the reagents needed to
process the current test requests.
When either button changes color, select it to display the Bulk Supplies or Supplies
Required screens for detailed information. For more information, see
Section 1.3: Software Overview.

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Bulk Supplies Use the Bulk Supplies screen to:

Screen • View the status of the bulk supplies and waste containers
• Change the in-use container of either the substrate, the wash buffer, or the
liquid waste
2026A.bmp
Substrate: Status Substrate Bottles

(Icon) Displays the substrate level in the two on-board substrate positions. As the
level of substrate in the in-use bottle decreases, the level displayed in the
corresponding icon also decreases.
Figure 2-3 Bulk Supplies Screen Descriptions

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Substrate: Status Status

(continued) (Field) Displays one of five possible status values:
• In Use - The system is using the bottle to process tests.
• Present - A bottle is present, but is not in use.
• Not Present - There is no bottle in the substrate position. The icon for a
not present bottle is gray on the screen.
• Empty - The bottle is empty, and must be changed. The icon for an empty bottle
is white on the screen. For more information, see the Changing an Empty or
Expired Substrate Bottle procedure in Section 2.2: Substrate.
• Disabled - The substrate position is disabled and cannot be used. The icon for a
substrate bottle in a disabled position is overlaid with a circular crossout symbol.
For more information, see Section 2.3: Supplies Setup of the Reference Manual.
Substrate: Tests Tests Left
Left (Field) Displays the number of tests the system can process with the substrate
supply.
• This field turns yellow if its associated on-board substrate bottle is empty. If
there is only one on-board bottle, the field turns yellow if the bottle has fewer
than 60 tests remaining.
• This field turns red if all on-board bottles are empty.
Substrate: Lot Lot Number
Number (Field) Displays the lot number of each substrate bottle.
• This field turns yellow if the substrate bar code was not read, if a bar code error
occurs, or if the lot expires in three days or sooner.
NOTE
If the bar code was not read, or if a bar code error occurs, a question mark (?) is
displayed in the field.
• This field turns red if the lot is expired.

Substrate: Bar Bar Code
Code (Field) Displays the bar code for each bottle of substrate. Because the bar codes are
17-18 characters long, they are displayed on three separate lines.
Figure 2-3 Bulk Supplies Screen Descriptions (continued)

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Substrate: Days to Days to Expiration

Expiration (Field) Displays the number of days until an open substrate bottle expires. The
expiration date is based upon the day the bottle was loaded onto the system.
• This field turns yellow if an open bottle expires in three days or sooner.
• This field turns red if an open bottle is expired.
NOTE
If a substrate bottle is disabled, this field will not turn yellow or red until the
bottle is enabled.
Wash Buffer: Bulk Wash Buffer Containers
Status (Icon) Displays the wash buffer level in the two on-board wash buffer positions. As
the level of wash buffer in the in-use container decreases, the level displayed in the
corresponding icon also decreases.
Status
(Field) There are five possible status values:
• In Use - The system is using the container to process tests.
• Present - A container is present, but is not in use.
• Not Present - There is no container in the wash buffer position. The icon for a
not present container is gray on the screen.
• Empty - The container is empty, and must be changed. The icon for an empty
container is white on the screen. For more information, see the Changing an
Empty Bulk Wash Buffer Container in Section 2.3: Wash Buffer.
• Disabled - The container position is disabled and cannot be used. The icon for a
container in a disabled position is overlaid with a circular crossout symbol. For
more information, see Section 2.3: Supplies Setup of the Reference Manual.
Wash Buffer: Estimated % Full
Estimated % Full (Field) Displays a percentage estimate of the available wash buffer in the loaded
bulk wash buffer containers.
• This field turns yellow if one of the on-board containers is low.
• This field turns red if all on-board containers are low. If there is only one
on-board container, the field turns red when the container has 10% of its volume
available for processing.

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RV Supply Vessel Hopper

(Icon) Displays the RV level in the vessel hopper. As the level of RVs in the
hopper decreases, the level displayed in the icon also decreases.
Estimated RVs Left
(Field) If there are more than 1,000 RVs in the vessel hopper, the field reads
>=1000. If there are fewer than 1,000 RVs, the field displays an estimate of the
remaining number of RVs.
• This field turns yellow if there are fewer than 1,000 RVs remaining in the
hopper.
• This field turns red if there are fewer than 100 RVs remaining in the hopper.
Liquid Waste: Bulk Liquid Waste Containers
Status (Icon) Displays the liquid waste level in the two on-board liquid waste positions.
(for systems using As the level of liquid waste in the in-use container increases, the level displayed in
on-board bulk the corresponding icon also increases.
liquid waste Status
containers) (Field) There are five possible status values:
• In Use - The system is using the container to collect liquid waste.
• Present - A container is present, but is not in use.
• Not Present - There is no container in the liquid waste position. The icon for a
not present container is gray on the screen.
• Full - The container is full, and must be changed. The icon for a full container is
blue on the screen. For more information, see the Changing a Full Bulk Liquid
Waste Container procedure in Section 2.5: Liquid Waste.
• Disabled - The container position is disabled and cannot be used. The icon for a
container in a disabled position is overlaid with a circular crossout symbol. For
more information, see Section 2.3: Supplies Setup of the Reference Manual.
Liquid Waste: Estimated % Empty
Estimated % (Field) Displays a percentage estimate of the available space in the on-board bulk
Empty liquid waste containers.
(for systems using • This field turns yellow if one of the on-board containers is almost full.
on-board bulk • This field turns red when all on-board containers are full. If there is only one
liquid waste on-board container, the field turns red when the container has 9% of its volume
containers) available for collecting waste.

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Solid Waste Solid Waste Container

(Icon) Displays the solid waste level in the on-board solid waste container. As the
level of solid waste in the container increases, the level displayed in the icon also
increases.
Estimated % Empty
(Field) Displays a percentage estimate of the available space in the solid waste
container.
• This field turns yellow when the container has 10% of its space available for
collecting waste.
• This field turns red when the container is full.
Reagent Supplies (Button) Select to display the Reagent Supplies screen. For more information, see
F1 Section 2.7: Reagent Supplies.
Change In-Use (Button) Select to display a menu with the following options:
Bottle Substrate F1
F3 Select to change the in-use substrate bottle. For more information, see the
Changing an In-Use Substrate Bottle procedure in Section 2.2: Substrate.
Liquid Waste F2 (for systems using on-board bulk liquid waste containers)
Select to change the in-use bulk liquid waste container. For more information, see
the Changing an In-Use Bulk Liquid Waste Container procedure in Section 2.5:
Liquid Waste.
Wash Buffer F3
Select to change the in-use bulk wash buffer container. For more information, see
the Changing an In-Use Bulk Wash Buffer Container procedure in Section 2.3:
Wash Buffer.
NOTE
If you cannot change the in-use bottle for any of the three reagents, its button is
not available.
Reagent Inventory (Button) Select to display the Reagent Inventory screen. For more information, see
F8 Section 2.8: Reagent Inventory.

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Supplies The Supplies Required screen lists the supplies or calibrations required to complete
Required your test requests. Use this screen to:
Screen • Determine which supplies require immediate attention
• Determine which assays require calibration
• Determine if an instrument condition requires attention, such as a disabled
pipettor
• Link to information in the Help system related to instrument conditions that
require attention
• Override certain supply and calibration conditions and continue processing
• Print the Supplies Required Report
2034B.bmp
Racks to Process (Field) Displays the total number of racks in the SPU that are waiting to be
processed. If the SPU door is open, the message SPU Open is displayed.
Figure 2-4 Supplies Required Screen Descriptions

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Required (Column) Displays the action or quantity required to relieve the supply, instrument,
or calibration condition. If there are no racks in the SPU that are ready to process,
the message No racks to process is displayed in the first row of the Supplies
Required table.
Supply (Column) Displays the name of the supply required and the corresponding icon. If
the supply required is curve-related (no curve, or an expired curve), the name of the
assay that requires calibration is displayed if it is different than the reagent pack
name. For example, if fTSH2 is ordered, the fTSH2 assay is displayed rather than
its associated pack name TSH.
Lot Number (Column) Displays the reagent pack lot number only when a reagent pack is
expired or needs a calibration. Otherwise, the entry for this column is blank.
Status (Column) Displays the calibration or expiration status of the supply. For critical
instrument check conditions, a Help button is displayed that links directly to the
procedure for rectifying the condition.
Otherwise, the entry for this column is blank.
Print (Button) Select to print the Supplies Required Report. For more information, see
F7 the Printing the Supplies Required Report procedure.
Override (Button) Select to continue sample processing with all of the expired supplies and
F8 expired or missing calibrations displayed on this screen. This button is only
available when you can override a supply or calibration condition. For more
information, see the Overriding Supply Conditions procedure.
Figure 2-4 Supplies Required Screen Descriptions (continued)

C73199-AA
Overriding You can start sample processing using expired calibrations, substrate, reagent packs,
Supply or reagent lots, and diluent packs or lots by overriding the current conditions. The
Conditions system applies appropriate flags to the affected test results and logs a corresponding
event in the Event Log.
NOTES
• You can use this procedure to run tests with a reagent pack that expires while
it is onboard the system. However, if a pack expires while it is offboard the
system, performing this procedure will not allow you to use the pack, even if
another pack from the same lot is onboard the system when the expiration
occurs.
• If you override a reagent pack that is not calibrated, the sample is processed
but the results are not reported.
• If you are recalibrating an expired calibration and running STAT tests for the
assay at the same time, override the expired calibration. The system
recalibrates the assay and then runs the STAT tests. Until you select
Override F8, the STAT test requests stay in the Supply Wait status.
Use this procedure to override supply conditions.

1. Select the Supplies Required button to display the Supplies Required screen.
 (Optional) To override some supply conditions but not others, first correct the
conditions you do not intend or are not allowed to override. For more
information, see the Resolving Supplies Required Conditions procedure.
Example
You may have an expired Free T4 reagent pack and a Cortisol pack with an
expired calibration, and you only intend to override the Cortisol calibration.
Unload the expired Free T4 pack and load an unexpired Free T4 pack. Then
return to the Supplies Required screen and perform the override procedure.
Cortisol will be removed from the list on the Supplies Required screen and the
subsequent Cortisol test results will be flagged.
2. Select Override F8.

The system removes the overridden expired supplies or calibrations from the list on
the Supplies Required screen, and processes the tests using the overridden expired
supplies or calibrations.

C73199-AA
Resolving Use this procedure as general guidance for correcting conditions displayed on the
Supplies Supplies Required screen.
Required The most critical instrument check conditions are listed toward the top of the table
Conditions within the Supplies Required screen, followed by Bulk Supplies Required, and then
Reagent Supplies Required.
System Mode: Any Mode

1. Select the Supplies Required button to display the Supplies Required screen.
2. In the Required column, an action to correct the condition is displayed. If the
condition is a critical instrument check condition, a Help button is available in the
row for the condition. Click the inline Help button to directly access the Help
topic associated with the condition.
3. Perform the recommended action and return to the Supplies Required screen.
If the condition resolved was an instrument state condition, the Supplies Required
icon turns from red to yellow (assuming all instrument check conditions have been
resolved and additional supplies require attention).

C73199-AA
Printing the The Supplies Required report is a printout of the entries on the Supplies Required
Supplies screen. To print a copy of the report, select Print F7 on the Supplies Required screen.
Required System Mode: Any Mode
Report
Laboratories, Inc.
Supplies Required Report Laboratory A
UniCel DxI 800, Access Immunoassay System 123 Lake Street
Townsville, ST 33333
S/N 654321, Version 4.4 101-555-2323 ext. 109 Jane Smith
Racks to be Scanned: 0
Required Supply Lot Number Status

No Racks to Process
Initialize System Bulk Feeder Disabled
Prime Fluidics Wash Buffer Bubble Detector
Enable or Configure Pipettor Pipettor #1
Change Substrate
Load 1 Pack AFP
Recalibrate TotT3 990804 Calibration Expired
Calibrate Ferritin 100220 No Calibration
Fill RV Supply
Empty Solid Waste
Empty Liquid Waste
Change Wash Buffer
Page 1 of 1
Technologist ____________________ Printed 02/08/11 04:03 PM
2052D.bmp
Figure 2-5 Supplies Required Report Example

C73199-AA
2.2: Substrate UniCel DxI Operator's Guide
2.2 Substrate
The UniCel DxI system uses substrate to measure the amount of analyte in a
processed test. For more information, see Section 1.2: Assay Technology in the
Reference Manual.
A substrate bottle is stored refrigerated to maintain its stability. Prior to use, a bottle is
equilibrated to room temperature in the substrate equilibration area located
underneath the reagent load door. The equilibration area of the UniCel DxI 800
instrument is partitioned, and holds up to four bottles of substrate (see Figure 2-10).
The equilibration area of the UniCel DxI 600 instrument holds up to two bottles (see
Figure 2-11). An unopened substrate bottle can remain at room temperature for 14
days.
When the bottle has equilibrated, you can load it on the system. You should have two
bottles on board the instrument at all times. When one bottle is empty, the system
automatically switches to the second bottle, and you can change the empty one. In
some circumstances, it may be necessary to change the in-use substrate bottle. You
can change the in-use bottle through the user interface on the Bulk Supplies screen.
Once you change an in-use substrate bottle it must be discarded.
All substrate bottles are labeled with a bar code. The system uses the information on
the bar code label to track lot number, serial number, expiration date, and the number
of tests remaining in the bottle.
You can use the following system indicators to monitor your on-board substrate
supply levels:
• The Bulk Supplies button
• The Bulk Supplies screen

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UniCel DxI Operator's Guide 2.2: Substrate
Monitoring The following table summarizes the different methods available to monitor substrate
the Substrate supply conditions.
Supply • Amber status indicator light (see Figure 1-3 in Section 1.2: Instrument
Overview)
• Substrate panel icon (UniCel DxI 800 instrument only - see Figure 2-2 in
Section 2.1: Supply and Supply Conditions Overview)
• Bulk Supplies status button (see Figure 1-12 in Section 1.3: Software
Overview)
• Substrate Status and Tests Left fields on the Bulk Supplies screen (see
Figure 2-3 in Section 2.1: Supply and Supply Conditions Overview)
If the system indicators are Then one or more of these

responding in each of these substrate supply conditions
ways: exist:
• The Amber status indicator light is lit • A lot expires in three days or sooner
• One of the Substrate panel icons is • An open bottle expires in three days
lit (UniCel DxI 800 instrument only) or sooner
• The Bulk Supplies button turns • One of the on-board bottles is empty
yellow • There is only one on-board bottle,
• On the Bulk Supplies screen, the and it has fewer than 60 tests left
Substrate Status for a bottle is • One bottle is not present, or is not
Empty or Not Present, or the Tests recognized by the system
Left field turns yellow
• The Amber status indicator light • All lots are expired

blinks • All open bottles are expired
• Both of the Substrate panel icons • All on-board bottles are empty
blink (UniCel DxI 800 instrument
only) • No bottles are present, or are not
recognized by the system
• The Bulk Supplies button turns red
• On the Bulk Supplies screen, the
Substrate Status for both bottles is
Empty or Not Present, or the Tests
Left field turns red
Table 2-6 Monitoring Substrate Supply

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Changing an If there is a sufficient substrate supply, the system continues to process tests while you
Empty or change the empty or expired bottle. To change a bottle before it is empty or expired,
Expired see the Changing an In-Use Substrate Bottle procedure.
Substrate Use this procedure to change an empty or expired substrate bottle.

Bottle
1. Check the substrate status to determine how many bottles to change.
UniCel DxI 800 UniCel DxI 600
Check the Substrate panel icons (see Consult the Bulk Supplies screen to
Figure 2-2 in Section 2.1: Supply and determine whether a lot is near
Supply Conditions Overview). expiration or if a bottle is empty. For
Blinking: Change all empty or expired
more information, see
bottles. Section 2.1: Supply and Supply
Solid: Consult the Bulk Supplies screen
to determine whether a lot is near
expiration or if a bottle is empty. For
more information, see
Section 2.1: Supply and Supply
Table 2-7 Checking the Substrate Status
• If the substrate lot is nearing expiration, change the bottle within three days.
• If a bottle is empty, change the bottle that is not in use. If you cannot determine
the in-use bottle, consult the Bulk Supplies screen.
• If there is only one on-board bottle, load two new bottles.
CAUTIONS
• In the following step, do not force the substrate door open if it does not
raise automatically. Consult the system status panel (UniCel DxI 800
instrument only) or Bulk Supplies screen to confirm which bottle to
change.
• When the substrate door is raised the system drains substrate from the
lines back into the substrate bottle. This contaminates the remaining
volume of substrate. If you raise the door to the in-use substrate bottle
unintentionally, you cannot reload the in-use bottle. Always discard the
in-use bottle and load a fresh one.
2. Do not grasp the substrate load door handle. Instead, place a finger underneath the
handle and push up against the pressure until the door lifts approximately
1/4 inch. At this height, the system automatically raises the door.

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3. Push inward on the front of the substrate load tray, then release quickly. The
system releases the tray approximately one inch. Grasp the sides of the tray and
pull out gently.
4. Lift the empty or expired bottle out of the tray and discard it.
4
5
2049A.eps
1 Substrate bottle
2 Substrate load door handle, raised
3 Substrate load door, closed
4 Substrate load door handle, closed
5 Substrate load tray
Figure 2-8 UniCel DxI 800 Instrument: Changing a Substrate Bottle

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3
2
2049B.eps
1 Substrate bottle
2 Substrate load tray
3 Substrate load door handle, closed
4 Substrate load door, closed
5 Substrate load door handle, raised
Figure 2-9 UniCel DxI 600 Instrument: Changing a Substrate Bottle
5. Lift up on the reagent load door (see Figure 2-35 in Section 2.7: Reagent
Supplies). If the reagent tray in-use light is green, wait until the light turns off
before opening the door.

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4
3
2
1
2050A.eps
1 Substrate equilibration area

2 Substrate bottle
Figure 2-10 UniCel DxI 800 Instrument Substrate Bottle Equilibration Area

C73199-AA
4
3
2
1
2050B.eps
1 Substrate equilibration area

2 Substrate bottle
Figure 2-11 UniCel DxI 600 Instrument Substrate Bottle Equilibration Area
6. Remove a full bottle from the substrate equilibration area.
7. Close the reagent load door.
8. Remove the cap from the new bottle and discard it.
9. Place the new bottle in the load tray with the bar code label facing out.
10. Push the load tray in until it locks in place.
11. Keep your fingers away from the open door. The system automatically lowers the
door after a three second delay.
12. Scan the bar code label through the window in the substrate load door. For more
information, see the Scanning the Substrate Bar Code Label procedure.
13. Remove a new, unequilibrated substrate bottle from storage and write the current
date and time on the label.

C73199-AA
14. Lift up on the reagent load door. If the reagent tray in-use light is green, wait until
the light turns off before opening the door.
15. Replace the equilibrated bottle you removed in step 6.
DxI 800 DxI 600
Check the Substrate panel Check the Bulk Supplies

icons for container status screen for container status
Open the substrate load door

and release the load tray
Remove the empty or

expired bottle and discard
Remove a new bottle from

the substrate equilibration
area
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
2017C.wmf
Figure 2-12 Changing the Substrate Bottle Flowchart

C73199-AA
Scanning the Use this procedure to scan the substrate bar code label with the substrate bar code
Substrate Bar reader.
Code Label
NOTE
You have 30 seconds to scan the substrate bar code label after the system closes
the substrate load door. If you do not scan the bar code within 30 seconds, a
substrate timeout error occurs. The substrate load door opens automatically and a
message is sent to the Event Log. For more information, see the Resolving
Substrate Bar Code Errors procedure.

1. Begin this procedure as the substrate load door is closing on a newly loaded
substrate bottle. For more information, see the Changing an Empty or Expired
Substrate Bottle procedure.
2. Remove the substrate bar code reader from its holder in front of the reagent load
area. For the location of the bar code reader, see Figure 1-1 (UniCel DxI 800
instrument) or see Figure 1-2 (UniCel DxI 600 instrument) in Section 1.2:
Instrument Overview.
3. Rotate the bar code reader approximately 90 degrees until the trigger is horizontal
to the floor.
4. Aim the bar code reader at the bar code label that is visible through the substrate
load door. Hold the reader approximately 1 to 8 inches (2.5 to 20.3 cm) from the
label.
5. Squeeze and hold the trigger, center the red light (indicating the scanning area)
within the lines of the bar code, and then release the trigger.
The bar code reader beeps if the bar code is read successfully and updates the
substrate information on the Bulk Supplies screen. The Substrate panel icon returns
to its unlit state in approximately five seconds.
NOTE
If the system reads the bar code successfully but does not accept it, a substrate bar
code scan error occurs. For more information, see the Resolving Substrate Bar
Code Errors procedure.
6. Return the substrate bar code reader to its holder.

C73199-AA
Resolving Two substrate bar code errors can occur while you change a substrate bottle.
Substrate Bar • Timeout errors for bar codes not successfully scanned within 30 seconds of
Code Errors closing the substrate load door.
• Scan errors for bar codes that the system cannot read.
Use this procedure to resolve a substrate bar code error.

1. Begin this procedure when either the Bar Code Timeout window or the Bar Code
Scan Error window is displayed while you are changing the substrate bottle. For
more information, see the Scanning the Substrate Bar Code Label procedure.
2200A.bmp
Open substrate door (Option) Select to open the substrate load door. If a
bar code timeout error has occurred, this option is not
available.
Rescan bottle (Option) Select to rescan the substrate bar code label.
Enter bar code (Option) Select to manually enter the substrate bar
code using the keyboard.
Figure 2-13 Substrate Bar Code Error (Scan View) Window Descriptions
2. Select an option to resolve the error.

• If a timeout error occurred because the bar code label was not visible to scan,
remove the bottle and place it correctly in the tray. For more information, see the

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Changing an Empty or Expired Substrate Bottle procedure. Then select the

Rescan Bottle option and scan the bottle again.
• If a timeout error occurred because you did not scan a visible bar code label
within 30 seconds, select the Rescan Bottle option and scan the bottle again.
• If a bar code scan error occurred, select the Enter Bar Code option and type the
bar code from the keyboard.
3. Select Done F1.
NOTE
If you have not returned the substrate bar code reader to its holder, do so now.
Changing an You cannot change the in-use substrate bottle if the second bottle is empty or was not
In-Use loaded, if the second position is disabled, or if the bar code was not scanned.
Substrate
NOTE
Bottle
When you change an in-use substrate bottle, the system cancels all of the tests
remaining in the bottle. The bottle cannot be used again and must be discarded.
Use this procedure to change the in-use substrate bottle.

1. From the Bulk Supplies screen, select Change In-Use Bottle F3.
2. Select Substrate F1.

The Switch Substrate window is displayed, informing you that the substrate remaining
in the in-use bottle cannot be used.
3. Select OK F1 to continue switching the in-use substrate bottle.
4. The system changes the in-use bottle and updates the Status field on the Bulk
Supplies screen.
CAUTION
To avoid contaminating the substrate supply, always discard partial bottles
of substrate. Do not combine partial bottles or try to load a partial bottle on
another instrument.
5. Change and discard the old bottle. For more information, see the Changing an
Empty or Expired Substrate Bottle procedure.

C73199-AA
UniCel DxI Operator's Guide 2.3: Wash Buffer
2.3 Wash Buffer
WARNING
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.
The UniCel DxI system uses wash buffer to:

• Dilute samples or reagents
• Wash away unbound material in the RVs
• Wash the pipettor probes
• Prime the system
The wash buffer supply drawer is on the lower right as you face the instrument. For
the location of the wash buffer supply drawer, see Figure 1-1 (UniCel DxI 800
instrument) or see Figure 1-2 (UniCel DxI 600 instrument) in Section 1.2: Instrument
Overview. The drawer holds two 10-liter bulk wash buffer containers, which is
enough for at least three hours of continuous processing.
You should have two containers on board the instrument at all times. The system
draws wash buffer from one container. When the container is empty, the system
automatically switches to the second, and you can change the empty one. In some
circumstances, it may be necessary to change the in-use wash buffer container. You
can change the in-use container through the user interface on the Bulk Supplies
screen.
You can use the following system indicators to monitor your on-board wash buffer
supply levels:

C73199-AA
2.3: Wash Buffer UniCel DxI Operator's Guide
Monitoring The following table summarizes the different methods available to monitor wash
the Wash buffer supply conditions.
Buffer Supply • Amber status indicator light (see Figure 1-3 in Section 1.2: Instrument
Overview)
• Wash Buffer panel icons (UniCel DxI 800 instrument only - see Figure 2-2
in Section 2.1: Supply and Supply Conditions Overview)
Overview)
• Wash Buffer Status and Estimated % Full fields on the Bulk Supplies
screen (see Figure 2-3 in Section 2.1: Supply and Supply Conditions
Overview)
If the system indicators are Then one or more of these wash

responding in each of these buffer supply conditions exist:
ways:
• The Amber status indicator light is lit • One of the on-board containers is low
• One of the Wash Buffer panel icons • One container is not present
is lit (UniCel DxI 800 instrument
only)
• The Bulk Supplies button turns
yellow
Wash Buffer Estimated % Full field
turns yellow
• The Amber status indicator light • All on-board containers are low
blinks • There is only one on-board container,
• Both of the Wash Buffer panel icons and it has 10% or less of its volume
blink (UniCel DxI 800 instrument available for processing
only) • No containers are present
Wash Buffer Estimated % Full field
turns red
Table 2-14 Monitoring Wash Buffer Supply

C73199-AA
Changing an If there is a sufficient wash buffer supply, the system continues to process tests while
Empty Bulk you change the empty bulk wash buffer container. To change a wash buffer container
Wash Buffer before it is empty, see the Changing an In-Use Bulk Wash Buffer Container
procedure.
Container
Use this procedure to change an empty bulk wash buffer container.
WARNING
suitable gloves.

1. Check the wash buffer status to determine which container is in use and how
many containers to change.
Check the Wash Buffer panel icons Consult the Bulk Supplies screen (see
(see Figure 2-2 in Section 2.1: Supply Section 2.1: Supply and Supply
and Supply Conditions Overview). Conditions Overview).
Blinking: Change all low wash buffer If the Wash Buffer Estimated % Full
containers. If there is only one on-board field is red, change all low wash buffer
container, load two new containers. containers. If there is only one on-board
Solid: Change the wash buffer
container, load two new containers.
container that is not in use. If the Wash Buffer Estimated % Full
• If you cannot determine the in-use field is yellow, change the wash buffer
container, consult the Bulk Supplies container that is not in use.
screen. For more information, see
Table 2-15 Checking the Wash Buffer Status
2. Pull out the wash buffer supply drawer. For the location of the wash buffer supply
drawer, see Figure 1-1 (UniCel DxI 800 instrument) or see Figure 1-2
(UniCel DxI 600 instrument) in Section 1.2: Instrument Overview.
3. Remove the perforated cardboard panels at the top and the sides of a new wash
buffer container.
4. Gently mix the new wash buffer container.
5. Place the new wash buffer container on the floor adjacent to the open supply
drawer and the container you are replacing.
6. Grasp the cap on the new container and pull upward until the plastic neck is
completely extended.

C73199-AA
7. Remove the cap and inner seal from the new container.
8. Determine if the wash buffer container is fitted with the original or redesigned
assembly (see Figure 2-16).
2
1
2
5
3
3
2378A.eps 2376A.eps
Original Cap/Draw Tube Assembly Redesigned Cap and Tube Assembly
1 Cap with disconnect button 1 Cap with no disconnect button

2 Disconnect button 2 Sensor tube
3 Draw tube 3 Clips (2 total)
4 Pressure sensor
5 Wash buffer supply tube
Figure 2-16 Original and Redesigned Wash Buffer Container Assemblies
9. If the wash buffer container is fitted with an original assembly (includes a tubing
disconnect button), continue with step 10 of this procedure.
If the wash buffer container is fitted with a redesigned assembly (no disconnect
button), perform the Changing an Empty Wash Buffer Container with a Redesigned
Cap and Tube Assembly procedure which immediately follows this procedure.
10. Press the disconnect button to release the fitting and tubing from the cap/draw
tube assembly on the empty container. If the fitting does not release, pull up
gently on the fitting while pressing the disconnect button.

C73199-AA
11. Lift the empty container from the supply drawer and replace it with the new
container.
CAUTION
To avoid contaminating the wash buffer supply, do not touch the draw tube
in the following steps. Handle the cap/draw tube assembly by the cap only.
12. Unscrew the cap/draw tube assembly on the empty container and carefully
remove it from the container. Be sure to lift the draw tube completely out of the
container before moving it (see Figure 2-17).
1
4
3
T
H
IS
E
N
D
U
P
F
R
T
O
H
N
IS
T
E
N
D
U
P
5
FR
ON
T
2056A.eps
1 Draw tube
2 Disconnect button
3 Bulk wash buffer containers
4 Cap/draw tube assembly
5 Cap fitting and tubing
Figure 2-17 Changing the Bulk Wash Buffer Container (Original Cap/Draw
Tube Assembly With a Disconnect Button)
13. Lower the cap/draw tube assembly into the new container and tighten the cap.
14. Connect the fitting into the cap/draw tube assembly on the new container.

C73199-AA
15. Carefully push in the drawer. Be sure that none of the wash buffer tubing is
pinched between the drawer and the wall.
16. Discard the empty container.
Changing an Empty Wash Buffer Container with a Redesigned

Cap and Tube Assembly
1. Remove the shim from the empty wash buffer container. Slide the shim out from
underneath the extended plastic neck (see Figure 2-18).
NOTE
Do not discard the shim after you remove it from the empty container. You will
need the shim in step 2 of this procedure.
2. Slide the shim into place underneath the extended plastic neck of the new wash
buffer container.
3. Lift the empty container from the wash buffer supply drawer and set it beside the
new container.
CAUTIONS
• To avoid contaminating the wash buffer supply, do not touch the wash
buffer supply or sensor tubes in the following steps. Handle the cap and
tube assembly by the cap only. Do not set the cap and tube assembly on
any surface after you remove it from the empty container.
• Handle the cap and tube assembly carefully in the following steps.
Pulling on the sensor electrical wires too vigorously or too often can
damage the wires, or disconnect them from the instrument or the
assembly.
4. Unscrew the cap and tube assembly on the empty container and carefully remove
it from the container. Lift the wash buffer supply and sensor tubes completely out
of the container before moving the cap and tube assembly (see Figure 2-18).

C73199-AA
2377A.eps
1 Cap with no disconnect button

2 Shim
3 Bulk wash buffer containers
Figure 2-18 Changing the Bulk Wash Buffer Container (Redesigned Cap
and Tube Assembly With No Disconnect Button)
5. Check the condition of the sensor electrical wires, the sensor and wash buffer
supply tubes, and the clips that hold both tubes in place.
a. Be sure that the sensor electrical wires are not stretched too far, and that the
connectors are not broken or disconnected from the instrument or the
assembly.
b. Be sure that the sensor and wash buffer supply tubes are not bent or broken.
c. Be sure that the clips are not missing or broken.
Contact Technical Support if the sensor electrical wires, the sensor tube, or the wash
buffer supply tube are damaged or broken, or if the clips are broken or missing.
6. Lower the cap and tube assembly into the new container and gently tighten the
cap.
7. Set the new wash buffer container in the empty position inside the supply drawer.
Route the tubing alongside the wash buffer container, between the container and
the drawer wall.
8. Carefully push in the drawer. Be sure that none of the wash buffer tubing is
pinched between the drawer and the instrument.
9. Discard the empty container.

C73199-AA
DxI 800 DxI 600
Check the Wash Buffer Check the Bulk Supplies

panel icons for container screen for container status
status
Pull out the wash buffer

supply drawer
Remove the perforated

panels from a new container
and gently mix the container
Extend the neck of the new

container and remove the
cap and inner seal
Is there a
disconnect on the No
cap and tube
assembly?
Yes Remove the shim from the

empty container and slide it
into place on the new
container
Press the disconnect button Remove the empty container

on the empty container to from the drawer and set it
release the tubing beside the new container
Remove the cap and tube

Remove the empty container
assembly from the empty
from the drawer and replace
container and insert it into
it with the new container
the new container
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
2018D.vsd
Figure 2-19 Changing an Empty Bulk Wash Buffer Container Flowchart

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Changing an You cannot change the in-use bulk wash buffer container if the second wash buffer
In-Use Bulk container is empty or was not loaded, or if the second position is disabled.
Wash Buffer Use this procedure to change the in-use bulk wash buffer container.
Container
2. Select Wash Buffer F3.
3. The system changes the in-use wash buffer container and updates the Status field
on the Bulk Supplies screen.
WARNING
suitable gloves.
4. Change the old container. For more information, see the Changing an Empty Bulk
Wash Buffer Container procedure.

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2.4: Reaction Vessels UniCel DxI Operator's Guide
2.4 Reaction Vessels
The UniCel DxI system uses reaction vessels (RVs) to:

• Store sample on board the instrument
• Prepare sample dilutions
• Incubate sample with assay-specific reagents during processing
The vessel hopper is located above the sample presentation unit (SPU) on the left side
of the instrument. For the location of the vessel hopper, see Figure 1-1
(UniCel DxI 800 instrument) or see Figure 1-2 (UniCel DxI 600 instrument) in
Section 1.2: Instrument Overview. The hopper holds up to two bags of approximately
1,000 RVs each. When the hopper is full, there are enough RVs for at least three hours
of continuous processing.
You can use the following system indicators to monitor your on-board RV supply
level:

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UniCel DxI Operator's Guide 2.4: Reaction Vessels
Monitoring The following table summarizes the different methods available to monitor RV supply
the RV Supply conditions.
• Amber status indicator light (see Figure 1-3 in Section 1.2: Instrument
Overview)
• RVs panel icon (UniCel DxI 800 instrument only - see Figure 2-2 in Section
2.1: Supply and Supply Conditions Overview)
Overview)
• Estimated RVs Left field on the Bulk Supplies screen (see Figure 2-3 in
If the system indicators are Then one or more of these RV

responding in each of these supply conditions exist:
ways:
• The Amber status indicator light is lit • The RV supply is low (fewer than
• The RVs panel icon is lit 1,000 RVs)
(UniCel DxI 800 instrument only)
yellow
Estimated RVs Left field turns
yellow
• The Amber status indicator light • The RV supply is very low (fewer
blinks than 100 RVs)
• The RVs panel icon blinks • The RV supply is depleted
Estimated RVs Left field turns red
Table 2-20 Monitoring RV Supply

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Adding RVs Use this procedure to add RVs to the vessel hopper.
WARNING
To avoid contaminating the RV supply, add full, previously unopened RV 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.

1. Check the RV status to determine how many bags of RVs to add to the vessel
hopper.
Check the RVs panel icons (see Consult the Bulk Supplies screen to
Figure 2-2 in Section 2.1: Supply and determine how many RVs to add (see
Supply Conditions Overview). Section 2.1: Supply and Supply
Blinking: Add enough RVs to fill the
Conditions Overview).
vessel hopper (nearly two bags). If there are fewer than 100 RVs, add
Solid: Add one bag of RVs.
enough RVs to fill the vessel hopper
(nearly two bags).
If there are between 100 and 1000 RVs,
add one bag of RVs.
Table 2-21 Checking the RV Status
2. Open the vessel hopper door by lifting upward.

C73199-AA
UniCel DxI Operator's Guide 2.4: Reaction Vessels
2088A.eps
1 Vessel hopper door

2 Vessel hopper
Figure 2-22 Adding RVs to the Hopper
3. Carefully open a bag of RVs by breaking the seal just underneath the top of the
bag.
CAUTION
In the following step, only add UniCel DxI system RVs to the hopper. If you
add other RVs or containers, the instrument will malfunction.
4. Carefully pour the RVs into the hopper using a side-to-side motion. This prevents
the RVs from accumulating in only one area of the hopper, and keeps the RV
level relatively even.
5. Close the vessel hopper door.

C73199-AA
DxI 800 DxI 600
Check the RVs panel icon Check the Bulk Supplies

for the number of RVs screen for RV status
required
Open the vessel hopper door
Open a bag of RVs and pour

the contents into the vessel
hopper
Close the vessel hopper

door
2019C.wmf
Figure 2-23 Adding RVs Flowchart

C73199-AA
UniCel DxI Operator's Guide 2.5: Liquid Waste
2.5 Liquid Waste
The UniCel DxI system uses a liquid waste drain or two on-board bulk liquid waste
containers to manage liquid waste. Liquid waste is generated when:
• The pipettors are washed between processing steps
• Unreactive fluids are washed from the RVs
WARNINGS
• Consider the liquid waste to be potentially infectious. Handle and dispose of
liquid waste according to proper laboratory procedures. Proper hand, eye,
and facial protection is required.
• 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).
If your system uses on-board bulk liquid waste containers, they are housed in the
liquid waste drawer on the lower left as you face the instrument. For the location of
the liquid waste drawer, see Figure 1-1 (UniCel DxI 800 instrument) or see Figure 1-2
(UniCel DxI 600 instrument) in Section 1.2: Instrument Overview. The drawer on the
UniCel DxI 800 instrument holds two 9.5-liter reusable bulk liquid waste containers.
The drawer on the UniCel DxI 600 instrument holds two 5-liter reusable bulk liquid
waste containers. For either instrument, the liquid waste containers collect the liquid
waste generated during three hours of continuous processing. The system dispenses
liquid waste into one container at a time. When the container is full, the system
automatically switches to the second, and you can change the full one. In some
circumstances, it may be necessary to change the in-use liquid waste container. You
can change the in-use container through the user interface on the Bulk Supplies
screen.

C73199-AA
2.5: Liquid Waste UniCel DxI Operator's Guide
You can use the following system indicators to monitor your on-board liquid waste
levels:
Monitoring The following table summarizes the different methods available to monitor liquid
the Liquid waste supply conditions if your system uses on-board bulk liquid waste containers.
Waste Supply • Amber status indicator light (see Figure 1-3 in Section 1.2: Instrument
Overview)
• Liquid Waste panel icons (UniCel DxI 800 instrument only - see Figure 2-2
in Section 2.1: Supply and Supply Conditions Overview)
Overview)
• Liquid Waste Status and Estimated % Empty fields on the Bulk Supplies
screen (see Figure 2-3 in Section 2.1: Supply and Supply Conditions
Overview)
If the system indicators are Then one or more of these liquid

responding in each of these waste supply conditions exist:
ways:
• The Amber status indicator light is lit • One of the on-board containers is
• One of the Liquid Waste panel icons almost full
is lit (UniCel DxI 800 instrument • One container is not present
only)
yellow
Liquid Waste Estimated % Empty
field turns yellow
Table 2-24 Monitoring Liquid Waste Supply

C73199-AA
• The Amber status indicator light • All on-board containers are almost
blinks full
• Both of the Liquid Waste panel • There is only one on-board container,
icons blink (UniCel DxI 800 and it has 9% or less of its volume
instrument only) available for collecting waste
• The Bulk Supplies button turns red • No containers are present
Liquid Waste Estimated % Empty
field turns red
Table 2-24 Monitoring Liquid Waste Supply (continued)
Changing a Use this procedure only if your DxI system uses on-board bulk liquid waste
Full Bulk containers.
Liquid Waste If there is sufficient volume available for collecting waste, the system continues to
Container process tests while you change a bulk liquid waste container. Use this procedure to
change a full bulk liquid waste container. To change a liquid waste container before it
is full, see the Changing an In-Use Bulk Liquid Waste Container procedure.
WARNINGS
• 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.
• Thoroughly flush any decontaminant from the liquid waste container before
you store the container. If you reuse a container without flushing it, any
remaining decontaminants may react with chemicals dispensed into the
waste container. The resulting chemical reactions may create gases harmful
to you or the instrument.

C73199-AA

1. Check the liquid waste status to determine which container is in use and how
many containers to change.
Check the Liquid Waste panel icons Consult the Bulk Supplies screen (see
(see Figure 2-2 in Section 2.1: Supply Section 2.1: Supply and Supply
and Supply Conditions Overview). Conditions Overview).
Blinking: Change all liquid waste If the Liquid Waste Estimated %
containers. If there is only one on-board Empty field is red, change all liquid
container, load two new containers. waste containers. If there is only one
Solid: Change the liquid waste
on-board container, load two new
container that is not in use. containers.
• If you cannot determine the in-use If the Liquid Waste Estimated %

Empty field is yellow, change the liquid
container, consult the Bulk Supplies
screen. For more information, see waste container that is not in use.
Table 2-25 Checking the Liquid Waste Status
2. Pull out the liquid waste drawer. For the location of the liquid waste drawer, see
Figure 1-1 (UniCel DxI 800 instrument) or see Figure 1-2 (UniCel DxI 600
instrument) in Section 1.2: Instrument Overview.
3. Place an empty liquid waste container on the floor adjacent to the open liquid
waste drawer and the container you are replacing.
4. Press the disconnect button to release the fitting and tubing from the cap
assembly. If the fitting does not release, pull up gently on the fitting while
pressing the disconnect button.
5. Lift the full container from the drawer and replace it with the empty container.
6. Connect the fitting into the cap assembly on the empty container.
7. Carefully push in the drawer. Be sure that none of the liquid waste tubing is
pinched between the drawer and the wall.
8. Decontaminate the contents of the full bulk liquid waste container according to
proper laboratory procedures before disposing of the liquid waste.
9. Dispose of the liquid waste according to proper laboratory procedures.

C73199-AA
10. Rinse the just-emptied container thoroughly by filling it with tap water and
discarding the contents to remove any traces of the decontaminant.
WARNING
Thoroughly flush any decontaminant from the liquid waste container before you
store the container. If you reuse the container without flushing it, any remaining
decontaminants may react with chemicals dispensed into the waste container.
The resulting chemical reactions may create gases harmful to you or the
instrument.
11. Store the clean container for future use.
2
3
1 4
2087A.eps
1 Liquid waste drawer

2 Bulk liquid waste container
3 Cap fitting and tubing
4 Vent
5 Disconnect button
Figure 2-26 Changing the Bulk Liquid Waste Container

C73199-AA
DxI 800
DxI 600
Check the Liquid Waste
Check the Bulk Supplies
panel icons for container
screen for container status
status
Pull out the liquid waste

drawer
Press the disconnect button

on the full container to
release the tubing
Remove the full container

and replace it with an empty
container
Connect the tubing to the

empty container and close
the drawer
Decontaminate the contents

of the full container and
dispose of the
liquid waste
Rinse the container

thoroughly and store it for
future use
2020C.wmf
Figure 2-27 Changing a Full Bulk Liquid Waste Container Flowchart

C73199-AA
Changing an Use this procedure only if your DxI system uses on-board bulk liquid waste
In-Use Bulk containers.
Liquid Waste If there is sufficient volume available for collecting waste, the system continues to
Container process tests while you change a bulk liquid waste container. Use this procedure to
change a bulk liquid waste container before it is full. To change a full liquid waste
container, see the Changing a Full Bulk Liquid Waste Container procedure.
You cannot change the in-use bulk liquid waste container if the second liquid waste
container is full or was not loaded, or if the second position is disabled.

2. Select Liquid Waste F2.
3. The system changes the in-use liquid waste container and updates the Status field
on the Bulk Supplies screen.
4. You can now change the old container. For more information, see the Changing a
Full Bulk Liquid Waste Container procedure.

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2.6: Solid Waste UniCel DxI Operator's Guide
2.6 Solid Waste
The solid waste container collects the empty reagent packs, used RVs, and
condensation generated by the UniCel DxI system during processing.
WARNING
Consider the solid waste to be potentially infectious. Handle and dispose of solid
waste according to proper laboratory procedures. Proper hand, eye, and facial
protection is required.
The solid waste container is a large plastic bin lined with a biohazardous waste bag.
There is only one container for solid waste. The container is stored behind the
pull-down door located between the liquid waste and wash buffer supply drawers. For
the location of the solid waste door, see Figure 1-1 (UniCel DxI 800 instrument) or
see Figure 1-2 (UniCel DxI 600 instrument) in Section 1.2: Instrument Overview.
When the container is empty, it can hold the solid waste generated during three hours
of continuous processing. When the container is full, the system continues processing
tests but does not process any new test requests.
CAUTION
Do not overfill the solid waste container. Excess solid waste may obstruct the
waste chute.
You can use the following system indicators to monitor your on-board solid waste
level:

C73199-AA
UniCel DxI Operator's Guide 2.6: Solid Waste
Monitoring The following table summarizes the different methods available to monitor solid
the Solid waste supply conditions.
Waste Supply • Amber status indicator light (see Figure 1-3 in Section 1.2: Instrument
Overview)
• Solid Waste panel icon (UniCel DxI 800 instrument only - see Figure 2-2 in
Overview)
• Solid Waste Estimated % Empty field on the Bulk Supplies screen (see
Figure 2-3 in Section 2.1: Supply and Supply Conditions Overview)
If the system indicators are Then one or more of these solid

responding in each of these waste supply conditions exist:
ways:
• The Amber status indicator light is lit • The container has 10% or less of its
• The Solid Waste panel icon is lit volume available for collecting waste
yellow
Solid Waste Estimated % Empty
field turns yellow
• The Amber status indicator light • The container is too full to schedule
blinks any new tests
• The Solid Waste panel icon blinks • The container is full
Solid Waste Estimated % Empty
field turns red
Table 2-28 Monitoring Solid Waste Supply

C73199-AA
Changing a The system continues processing tests while you change the full solid waste container,
Full Solid but does not initiate any new test requests. The system does not dispose of any solid
Waste waste until the empty container is in place again.
Container Use this procedure to change the solid waste container bag.
WARNING
You will come in contact with potentially infectious materials during this
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 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. For more information, see the Initializing the
System procedure in Section 4.2: Initialize System of the Reference
Manual, or see Running Clean Routines in Section 7.2: Daily
Maintenance.
1. Check the solid waste status.
Check the Solid Waste panel icon (see Consult the Bulk Supplies screen (see
Figure 2-2 in Section 2.1: Supply and Section 2.1: Supply and Supply
Supply Conditions Overview). Conditions Overview).
Blinking: Change the solid waste If the Solid Waste Estimated % Empty
container. field is red, change the solid waste
Solid: The solid waste container is
container.
almost full, change the container soon. If the Solid Waste Estimated % Empty
field is yellow, the solid waste container
is almost full, change the container
soon.
Table 2-29 Checking the Solid Waste Status

C73199-AA
UniCel DxI Operator's Guide 2.6: Solid Waste
2. Open the solid waste door by pulling down on the handle. For the location of the
wash solid waste door, see Figure 1-1 (UniCel DxI 800 instrument) or see
Figure 1-2 (UniCel DxI 600 instrument) in Section 1.2: Instrument Overview.
3. Slide the container out of the storage area.
2089A.eps
1 Solid waste door

2 Green reset button
3 Solid waste container
Figure 2-30 Changing the Solid Waste Container
4. Seal the biohazard bag lining the container by tying two ends of the bag together
in a knot.
5. Lift the sealed biohazard bag out of the plastic bin.
6. Line the container with a new biohazard bag. Expand the bag so it reaches the
sides of the container.
7. Slide the container back into the storage area.

C73199-AA
8. Press the green reset button mounted on the left side of the storage area.
NOTE
If you do not press the reset button, the system will not reset the system
indicators. If you changed a full container, the system will not process any new
test requests until you press the reset button.
9. Close the solid waste door.
DxI 800 DxI 600
Check the Solid Waste Check the Bulk Supplies

panel icon for container screen for container status
status
Pull down on the solid waste

door handle
Slide the full container out of

the storage area and seal
the waste bag
Remove the full waste bag

and insert a new bag into the
container
Slide the empty container

and bag into the storage
area
Press the green reset button

and close the door
2021C.wmf
Figure 2-31 Changing a Full Solid Waste Container Flowchart

C73199-AA
UniCel DxI Operator's Guide 2.7: Reagent Supplies
2.7 Reagent Supplies
The reagent supplies are on-board reagent packs. The UniCel DxI system uses two
types of reagent packs:
• Assay reagent packs
• Diluent packs
An assay reagent pack is a container that holds up to five assay-specific reagents in

individual wells. A diluent pack contains diluent and is used for onboard dilution
tests.
WARNING
Consider the assay-specific reagents inside the reagent packs to be potentially
infectious. Handle and dispose of reagent packs according to proper laboratory
procedures. Proper hand, eye, and facial protection is required.
You can monitor reagent supplies on the Reagent Supplies screen. The screen
contains 50 buttons that correspond to the 50 slots in the reagent storage chamber. An
empty button indicates an available slot in the storage chamber. The buttons are sorted
alphabetically down a column, and then numerically left to right.
During sample processing, the system monitors reagent dispense volume to assure
accurate delivery of reagents. If a reagent dispense error occurs, the system records an
event with troubleshooting information in the Event Log.
If three or more reagent dispense errors occur for a single reagent pack, the system
records an event in the Event Log and the reagent pack cannot be used. For this
reagent pack, any test requests which are not already in process are assigned to
another pack. If no other pack is available, the test requests are assigned to
Work Pending. For related troubleshooting information, see Section 5.4:
Event-Specific Troubleshooting in the Reference Manual.
The reagent loading area is located to the right of the sample presentation unit. For the
location of the reagent loading area, see Figure 1-1 (UniCel DxI 800 instrument) or
see Figure 1-2 (UniCel DxI 600 instrument) in Section 1.2: Instrument Overview.
You can load up to four packs at a time on the loading tray of the UniCel DxI 800
instrument (up to two packs at a time on the UniCel DxI 600 instrument). When you
shut the reagent load door, the instrument scans the reagent bar code and moves the

C73199-AA
2.7: Reagent Supplies UniCel DxI Operator's Guide
packs either to the reagent pipetting station or the reagent storage chamber. The
system moves or stores packs as they are needed to process tests.
You can unload up to four packs at a time on the Reagent Supplies screen for the
UniCel DxI 800 instrument (up to two packs at a time on the UniCel DxI 600
instrument), or unload them one at a time on the Reagent Inventory screen. For more
information, see Section 2.8: Reagent Inventory.
When a pack does not contain enough reagent to process the requested tests, or if the
pack lot or open pack expiration has expired, the system assigns those tests the
Supply Wait status. For more information, see Section 2.1: Supply and Supply
You can use the following system indicators to monitor your on-board reagent supply
levels:
• The Supplies Required button
• The Supplies Required screen
Monitoring The following table summarizes the different methods available to monitor reagent
the Reagent pack supply conditions. You can monitor supply conditions for individual packs on
Pack Supply the Reagent Supplies screen.
• Amber status indicator light (see Figure 1-3 in Section 1.2: Instrument
Overview)
• Console panel icon (UniCel DxI 800 instrument only - see Figure 2-2 in
• Supplies Required status button (see Figure 1-12 in Section 1.3: Software
Overview)
• Supplies Required screen (see Figure 2-4 in Section 2.1: Supply and Supply
Conditions Overview)
If the system indicators are Then one or more of these

responding in each of these reagent pack supply conditions
ways: exist:
Table 2-32 Monitoring Reagent Pack Supply

C73199-AA
• The Amber status indicator light is lit • No on-board reagent pack

• The Console panel icon is lit • A pack is on-board, but does not
(UniCel DxI 800 instrument only) have enough reagent to process all
• The Supplies Required button turns tests
yellow • Pack lot expired
• A pack is displayed on the Supplies • Open pack stability expired
Required screen
Table 2-32 Monitoring Reagent Pack Supply (continued)
Reagent Use the Reagent Supplies screen to:

Supplies • View specific details about the on-board reagent packs
Screen • Unload selected reagent packs, or unload all on-board reagent packs
• Print the Reagent Supplies Report
To get to this screen from the Bulk Supplies screen, select Reagent Supplies F1.

C73199-AA
2028C.bmp
Reagent Pack For each on-board reagent pack, the button displays the following information:
Button Test Name
(Button label) Displays the reagent inventory pack name. In the case of primary
and secondary tests, such as Folate and its secondary test RBC Folate, the primary
test name is displayed.
A reagent pack button with a red background and a white test name cannot be used.
For this reagent pack, any test requests which are not already in process are
assigned to another pack. If no other pack is available, the test requests are
assigned to Work Pending. See the Event Log for related troubleshooting
information.
A diluent pack button has a blue inventory pack name which begins with the letter
"d". This pack contains diluent and is used for onboard dilution tests only.
Lot
(Field) Displays the reagent pack lot number.
• This field turns yellow if the pack lot number or calibration expires in three days
or sooner.
• This field turns red if the pack lot number or calibration is expired, there is no
calibration, or if the pack bar code was not read.
NOTE
If you disable the test for a reagent pack, no expiration information is
provided. For more information, see Section 3.3: Test Setup in the Reference
Manual.
If the bar code was not read, a question mark (?) displays in the field.
Qty (for assay reagent packs only)
(Field) Displays the number of tests remaining in the reagent pack. The number
changes as the system uses the reagent.
• This field turns yellow if there are 10 tests or fewer remaining for all on board
packs with the same lot number, or if the open pack stability expires in three
days or sooner.
• This field turns red if there are no tests remaining in the pack, or if the open pack
stability has expired.
Figure 2-33 Reagent Supplies Screen Descriptions

C73199-AA
Reagent Pack In-Use Icon
Button, continued (Padlock) If the system is processing samples and the reagent pack is
scheduled for use, the system displays a padlock icon and disables the
Unload Reagent Packs F2 button to prevent you from removing the
pack. You cannot remove in-use packs until the system aspirates the reagent for the
current run.
The system updates the Reagent Pack buttons as you load and unload packs.
Bulk Supplies (Button) Select to display the Bulk Supplies screen. For more information, see the
F1 Bulk Supplies Screen topic in Section 2.1: Supply and Supply Conditions
Overview.
Unload Reagent (Button) Select to unload individual reagent packs. You can unload up to four
Packs reagent packs at a time on the UniCel DxI 800 instrument (up to two packs at a
F2 time on the UniCel DxI 600 instrument). For more information, see the Unloading
a Reagent Pack procedure.
Unload All Reagent (Button) Select to unload all of the reagent packs from the reagent storage
Packs chamber. For more information, see the Unloading All Reagent Packs procedure.
F3
Details (Button) After selecting a Reagent Pack button, select to display more detailed
F6 information about the reagent pack. This information includes:
• Lot number
• Serial number
• Expiration date
• For a diluent pack, the number of dilutions remaining for each test.
For more information, see the Displaying and Printing Reagent Pack Details
procedure.
Print (Button) Select to print the Reagent Supplies Report for all on-board reagent packs.
F7 For more information, see the Displaying and Printing Reagent Pack Details
procedure.
Figure 2-33 Reagent Supplies Screen Descriptions (continued)

C73199-AA
Displaying The Reagent Supplies screen displays summary information about each on-board
and Printing reagent pack. The Reagent Supplies Report provides summary information about all
Reagent Pack on-board reagent packs. This report does not print information for individual reagent
packs.
Details
Use this procedure to display detailed information for one reagent pack, or to print the
Reagent Supplies Report.

1. From the Reagent Supplies screen, select a Reagent Pack button.
2. Select Details F6 to display the Details window.
3. Review the information that displays in the following fields:
• Pack Name • Pack Expiration Date

• Lot Number • Calibration Expiration Date
• Serial Number • Tests Left
• Dilutions Remaining
(for diluent packs only)
4. When you are done reviewing the information, select Done F1 to display the
Reagent Supplies screen.
5. To print the reagent pack details listed on the Reagent Supplies Report, select
Print F7.

C73199-AA
Laboratories, Inc.
Reagent Supplies Report Laboratory A
S/N 654321 101-555-2323 ext. 109 Jane Smith
Test Name Lot No. Serial No. Tests Days Pack Calib. Slot Instrument
Left Open Expiration Expiration
CK-MB 013055 231 2 8 04/27/04 10/15/03 1 654321
CK-MB 013055 232 2 8 04/27/04 10/15/03 2 654321
CK-MB 013040 234 2 8 04/27/04 None 3 654321
CK-MB 013055 235 25 6 02/28/04 10/15/03 4 654321
CK-MB 013055 236 25 6 02/28/04 10/15/03 5 654321
CK-MB 013040 481 25 4 02/28/04 None 6 654321
CK-MB 013055 483 50 0 01/31/04 10/15/03 7 654321
CK-MB 013055 484 50 0 01/31/04 10/15/03 8 654321
CK-MB 013040 841 10 12 04/20/04 None 9 654321
CK-MB 013055 842 50 0 01/31/04 10/15/03 10 654321
Ferritin 105011 2297 17 5 04/27/04 10/30/03 11 654321
Ferritin 125002 2296 27 4 04/28/04 None 12 654321
Ferritin 125002 2298 38 3 04/29/04 None 13 654321
Ferritin 105011 3011 17 5 04/27/04 10/30/03 13 654321
Ferritin 125002 3012 27 4 04/28/04 None 15 654321
Ferritin 125002 3010 38 3 04/29/04 None 16 654321
TSH 085673 3013 5 12 04/06/04 17 654321
TSH 10/20/03
fTSH2 None
TSH 085673 3454 5 12 04/06/04 18 654321
TSH 10/20/03
fTSH2 None
MYO 093738 3461 47 7 04/25/04 10/15/03 19 654321
MYO 093738 3462 47 7 04/25/04 10/15/03 20 654321
Page 1 of 1
Technologist ____________________ Printed 10/10/2003 14:36
2053D.bmp
Figure 2-34 Reagent Supplies Report Example

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Loading a If there is sufficient reagent available, the system continues to process tests while you
Reagent Pack load another reagent pack.
Use this procedure to load reagent packs onto the instrument.
WARNINGS
• Do not load partial packs from another UniCel DxI system onto your
instrument.
NOTES
• The system prevents you from accidentally loading empty or expired reagent
packs. You can use a pack that expires while it is onboard the instrument by
overriding the expired condition. However, selecting to override an expired
condition does not permit you to load a pack that expires while it is offboard,
even if another pack from the same lot is onboard when the expiration occurs.
For more information, see the Overriding Supply Conditions procedure in
Section 2.1: Supply and Supply Conditions Overview.
• Loading a reagent pack does not automatically enable its assay. If the assay is
disabled, you must enable it on the Tests Setup screen. For more information,
see Section 3.3: Test Setup of the Reference Manual.

1. Check the status of the reagent tray in-use light:
Off: The door is not locked. You can load reagent packs.
Green: The system is processing tests and the door is locked. Wait until the light turns
off before loading reagent packs.

C73199-AA
2085B.eps
1 Reagent tray in-use light

2 Reagent load door
3 Load door bottom edge
Figure 2-35 Reagent Load Area
2. Mix the new, unpunctured packs by gently inverting them several times to
dislodge particles from the seal or sides of the well. It is not necessary to
completely resuspend the particles.
NOTES
• Do not invert packs that have been punctured.
• Do not vigorously shake packs or use a vortex mixer, except for the Access
25(OH) Vitamin D Total assay. For the Access 25(OH) Vitamin D Total
assay, see the reagent IFU for pack mixing instructions.

C73199-AA
3. Open the reagent load door by lifting up on the bottom edge.
WARNING
In the following step, do not load partial packs from another system onto your
instrument.
CAUTION
To avoid damaging the reagent packs in the following step, be sure they are
properly seated in the tray positions.
4. Place up to four reagent packs in the tray on the UniCel DxI 800 instrument (up to
two packs on the UniCel DxI 600 instrument). Place the packs in the numbered
tray positions so the narrow end is at the back of the tray and the bar code label
faces up.
1
2 3
4
3
2
2086A.eps
1 Reagent pack
2 Reagent pack position
3 Reagent load tray
Figure 2-36 UniCel DxI 800 Instrument: Loading a Reagent Pack

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1 2
3
4
3
2
1
2086B.eps
1 Reagent pack
2 Reagent pack position
3 Reagent load tray
Figure 2-37 UniCel DxI 600 Instrument: Loading a Reagent Pack

The system moves the packs inside the instrument and reads the bar code labels. For
each successfully loaded pack, a Reagent Pack button is added to the Reagent
Supplies screen. For more information, see the Reagent Supplies Screen topic.
If you load an empty or expired pack, the system moves the pack to the reagent
storage chamber and a Reagent Pack button with a question mark (?) in the Test
Name field is added to the Reagent Supplies screen. The pack cannot be used for
normal processing. You can unload the pack at your next opportunity. For more
information, see the Unloading a Reagent Pack procedure.
6. Carefully review the Reagent Supplies screen to make sure the information for
the reagent pack just loaded is correct.

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WARNING
If you loaded 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.
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
2022D.wmf
Figure 2-38 Loading a Reagent Pack Flowchart

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Unloading a The system automatically unloads empty reagent packs and places them in the solid
Reagent Pack waste container. Use this procedure to manually unload a reagent pack. All
information for the unloaded pack remains in the database until you manually delete it
from inventory. For more information, see Section 2.8: Reagent Inventory.
WARNING

1. From the Reagent Supplies or Reagent Inventory screen, select the Reagent Pack
button for the pack you intend to unload.
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 unload only one reagent pack at a time on the Reagent Inventory
screen.
• If a reagent pack is in-use (identified by the in-use [padlock] icon on the
Reagent Supplies screen), you cannot unload it from the system.
2. Select Unload Reagent Pack F2.

The reagent tray in-use light turns green. A progress window is displayed while the
system retrieves the selected pack and delivers it to the loading area.
NOTE
If one or more of the selected packs cannot be unloaded, the Unload Reagent
Pack F2 button is not available.
3. When the reagent tray in-use light turns off, open the load door by lifting up on
the bottom edge (see Figure 2-35).
NOTES
• If you unload packs while the system is in the Running mode, it may take
longer than normal for the system to unlock the reagent load door.
• If you do not open the door within one hour, the system returns the pack to
the reagent storage chamber.
4. Remove the reagent pack from the tray.

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The system deletes the corresponding Reagent Pack button from the Reagent Supplies
screen.
NOTE
If you close the door before removing each pack from the tray, the remaining
packs are returned to the reagent storage chamber.
6. If you intend to use an unloaded pack again, store it upright in the refrigerator.
Use the pack before it expires.
(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
2023C.svg
Figure 2-39 Unloading a Reagent Pack Flowchart

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Unloading All Use this procedure to unload all reagent packs from the system. The system unloads
Reagent the packs, but maintains all pack information in the database.
Packs
WARNING
System Mode: Ready Not Ready

1. From the Reagent Supplies screen, select Unload All Reagent Packs F3 to
display the Unload All Packs window.
2030A.bmp
Moving Packs to Tray (Field) Monitors the system as it moves packs to

the tray. When the packs are ready to unload, a
message instructs you to unload packs now.
Unload all Packs - (Field) Monitors the system as it removes all
% Complete reagent packs from the reagent storage chamber.
Packs to Unload (Field) Displays the number of reagent packs
remaining in the reagent storage chamber.
Cancel (Button) Select to stop unloading the remaining
F8 on board reagent packs.
Figure 2-40 Unload All Packs Window Descriptions

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2. When the reagent tray in-use light turns off, open the reagent load door by lifting
up on the bottom edge (see Figure 2-35).
3. Remove the packs from the reagent tray and close the reagent door.
The system deletes the corresponding Reagent Pack buttons from the Reagent
Supplies screen, and begins moving the next set of reagent packs from the reagent
storage chamber to the tray.
NOTES
• The system waits until the reagent load door is closed to continue unloading
reagent packs.
• If you do not open the door within one hour, the system returns the packs to
the reagent storage chamber and cancels the operation.
4. Repeat steps 2 and 3 until all packs are removed from the instrument.
5. Select Exit F1.

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(Any Screen)
Bulk Supplies
Reagent Supplies F1
Unload All Rgt Packs F3
Wait for the reagent tray

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

and remove the packs
Are all of the No

Continue unloading packs
packs unloaded?
Yes
Select Exit F1
2024B.svg
Figure 2-41 Unloading All Reagent Packs Flowchart

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2.8: Reagent Inventory UniCel DxI Operator's Guide
2.8 Reagent Inventory
The UniCel DxI system keeps an inventory of all on-board and off-board reagent
packs. When you load or unload a reagent pack, the instrument scans the bar code
label and adds or removes an entry for the pack to the Reagent Inventory screen. The
system stores the pack inventory information until it is deleted.
The system tracks pack activity in inventory as processing occurs and as time until
expiration passes for each pack. When a pack is empty, the system discards it
automatically and deletes the pack from inventory. When a pack is expired, the
system notifies you of the condition. Unload the pack from the system and delete it
from inventory. For more information about assay specific open pack stability and
expiration times, see the reagent instructions for use. You can set up the system to
override an expired reagent pack. For more information, see Section 2.3: Supplies
Setup in the Reference Manual.
You can remove a reagent pack from the instrument, store it, and reload it when the
pack is needed. For more information, see Section 2.7: Reagent Supplies.
If necessary, you can manually delete full or partially full packs from the database.
For more information, see the Deleting a Reagent Pack procedure.
NOTE
Once a reagent pack is deleted from the inventory, it cannot be loaded again.

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UniCel DxI Operator's Guide 2.8: Reagent Inventory
Reagent Use the Reagent Inventory screen to:

Inventory • View the reagent pack inventory
Screen • Unload a reagent pack
• Monitor the inventory for upcoming pack and calibration expirations
• Delete a reagent pack from inventory
• Print the Reagent Inventory Report
To get to this screen from the Bulk Supplies screen, select Reagent Inventory F8.
2031A.bmp
Filter (Field) Displays the applied filter and sort order.

Open Slots (Field) Displays the number of empty reagent pack positions in the reagent storage
chamber.
Entries (Field) Displays the number of reagent packs that meet the applied filter and sort
order.
Figure 2-42 Reagent Inventory Screen Descriptions

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Test Name (Column) Displays the reagent pack test names that meet the filter criteria.
If a pack is used for more than one test, the system displays the primary and
secondary tests for that pack as two separate entries. When sorted, the primary and
secondary tests stay together. For example, the Folate pack is used to run a primary
test (Folate) and a secondary test (RBC Folate). The system displays both of the
tests, primary and secondary, underneath the primary test (Folate).
Lot No. (Column) Displays each pack lot number.
Serial No. (Column) Displays the unique pack serial number.
Tests Left (Column) Displays the number of tests remaining in each reagent pack.
NOTE
This column is not updated in real-time. To refresh the information on the
screen, exit the screen and redisplay it.
Days Open (Column) Displays the number of days since the system first punctured each
reagent pack.
Pack Expiration (Column) Displays the expiration date for each reagent pack. The expiration date is
the lot expiration date or the open pack expiration date, whichever is earliest.
The open pack expiration date is the date the system first punctured the reagent
pack, plus the number of days defined in the APF.
• This entry turns yellow if the open pack stability expires in three days or sooner.
• This entry turns red if the open pack stability is expired.
Calib. Expiration (Column) For on-board packs, displays the expiration date of the active calibration.
For off-board packs, displays Unloaded.
• This entry turns yellow if the calibration expires in three days or sooner.
• This entry turns red if the calibration is expired.
NOTE
For more information, see Chapter 5: Assay Calibration.

Slot (Column) Displays the position of each on-board reagent pack in the reagent
storage chamber. The slot positions are numbered from 1 to 50.
If the pack is off board, the entry is blank.
Instrument (Column) Displays the name of the instrument the reagent pack is loaded on.
If the pack is off board, the entry is blank.
Figure 2-42 Reagent Inventory Screen Descriptions (continued)

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Unload Reagent (Button) Select to unload one selected reagent pack. If the selected reagent pack is
Pack off board this button is not available. For more information, see the Unloading a
F2 Reagent Pack procedure in Section 2.7: Reagent Supplies.
The system updates the screen once the pack is unloaded.
NOTE
Delete Pack (Button) Select to delete an off-board reagent pack from inventory. When you
F5 delete a reagent pack, the system removes pack information from screens and
reports, but retains the information in the database. If the selected pack is on-board
the instrument, this button is not available. For more information, see the Deleting
a Reagent Pack procedure.
Print (Button) Select to print the Reagent Inventory Report for all reagent packs that
F7 meet the filter parameters. For more information, see the Printing the Reagent
Inventory Report procedure.
Filter (Button) Select to change the filter parameters and sort order to apply to the
F8 Reagent Inventory screen. The applied filter and sort order displays in the Filter
field. For more information, see the Applying a Filter to the Reagent Inventory
Screen procedure.
Figure 2-42 Reagent Inventory Screen Descriptions (continued)
Applying a A filter is a set of parameters you can apply to increase or decrease the number of
Filter to the reagent packs that display on the Reagent Inventory screen.
Reagent Use this procedure to apply a different filter to the Reagent Inventory screen.
Inventory
Screen System Mode: Any Mode
1. From the Reagent Inventory screen, select Filter F8 to display the Filter window.

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2032B.bmp
Filter (List) Select a filter that describes the inventory entries to

be displayed on the Reagent Inventory screen.
Pack Type (List) Select a pack type that describes the inventory
entries to be displayed on the Reagent Inventory screen.
Sort Order (Options) Select the pack attribute by which the packs
are sorted on the screen.
Ascending (Box) Select to sort the entries in ascending order, or
clear to sort the entries in descending order.
Figure 2-43 Filter (Reagent Inventory) Window Descriptions
2. Select a filter criteria.

• To include all the packs in inventory, select All Packs.
• To include on-board packs only, select On-Board Packs.
• To include off-board packs only, select Off-Board Packs.

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3. Select a pack type.

• To include reagent and diluent packs, select All Pack Types.
• To include reagent packs only, select Reagent Packs.
• To include diluent packs only, select Diluent Packs.
4. Select a sort order option.
NOTES
• If you select the All Packs filter, the Slot option is not available.
• If you select the Off-Board Packs filter, the Slot and Instrument sort order
options are not available.
5. Select or clear the Ascending option.
6. Select OK F1.
The Reagent Inventory screen displays the reagent inventory according to the applied
filter.
Deleting a Use this procedure to delete off-board reagent packs from inventory.
Reagent Pack
NOTES
• You cannot reload a reagent pack after you delete it.
• The system automatically unloads and deletes empty reagent packs from
inventory.
1. From the Reagent Inventory screen, select the off-board reagent pack you intend
to delete.
 (Optional) If you cannot locate a pack quickly, apply a filter that displays the
pack near the top of the inventory list. For more information, see the Applying a
Filter to the Reagent Inventory Screen procedure.
2. Confirm that the reagent pack you selected is off board by verifying that the Slot
and Instrument fields are blank.
 (Optional) If the reagent pack is on board the instrument, unload the reagent pack.
For more information, see the Unloading a Reagent Pack procedure
in Section 2.7: Reagent Supplies.
3. Select Delete Pack F5.
The system displays a confirmation window.
4. Select OK F1.
The system deletes the reagent pack.

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(Any Screen)
Bulk Supplies
Reagent Inventory F8
Reagent Inventory
Select the pack

you intend to delete
Is the pack off No

Unload the pack
board?
Yes
Delete Pack F5
OK F1
2025C.svg
Figure 2-44 Deleting a Reagent Pack Flowchart

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Printing the Use this procedure to print the Reagent Inventory Report, containing all selected
Reagent packs or all packs in the applied filter.
Inventory System Mode: Any Mode
Report 1. From the Reagent Inventory screen, confirm that the applied filter includes the
packs you intend to print, and that the packs are in the correct sort order. If not,
apply the appropriate filter and sort order. For more information, see the
Applying a Filter to the Reagent Inventory Screen procedure.
 (Optional) To print the Reagent Inventory Report for one or more selected packs,
select the packs you intend to print on the screen.
2. Select Print F7.

The system prints the Reagent Inventory Report for all packs displayed on the screen,
or for the packs selected on the screen.

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Laboratories, Inc.
Reagent Inventory Report Laboratory A
S/N 654321 101-555-2323 ext. 109 Jane Smith
Filter: All Packs -- Sorted by Test Name

Test Name Lot No. Serial No. Tests Days Pack Calib. Slot Instrument
Left Open Expiration Expiration
PSA-Hyb 066851 3461 8 20 06/30/04 4 654321
PSA-Hyb 10/18/03
PSA-WHO None
MYO 093738 14283 47 7 04/25/04 10/15/03 8 654321
TSH 085673 232 5 12 04/06/04 3 654321
TSH 10/20/03
fTSH2 None
Ferritin 105011 1259 17 5 04/27/04 10/12/03 6 654321
Ferritin 125002 3374 27 4 04/28/04 Unloaded
Ferritin 125002 1121 38 3 04/29/04 Unloaded
Dig 123123 11863 50 0 01/31/04 10/15/03 1 654321
Dig 123123 8715 47 7 01/31/04 10/15/03 2 654321
Dig 123123 4168 0 12 01/31/04 10/15/03 4 654321
Dig 123123 1122 0 18 01/31/04 10/15/03 17 654321
CK-MB 013055 956 50 0 04/27/04 None 15 654321
CK-MB 013055 842 50 0 04/27/04 None 14 654321
CK-MB 013040 1010 10 12 04/27/04 10/15/03 9 654321
Page 1 of 1
2054C.bmp
Figure 2-45 Reagent Inventory Report Example

C73199-AA
UniCel DxI Operator's Guide 3: Sample Manager
3 Sample Manager
3.1 Sample Manager Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Sample Manager Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Sample Manager Screen Views . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Selecting a Sample Manager Screen View . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
Entering a Date on the Daily View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
Clearing an Exception from the Exceptions View. . . . . . . . . . . . . . . . . . . . . 3-11
Finding a Sample ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
Displaying Test Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
Resolving Sample Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-14
3.2 LIS Requests and Work Pending . . . . . . . . . . . . . . . . . . . . . . . . . . 3-15
Work Pending Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16
Downloading LIS Test Requests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
Querying the LIS for Test Requests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
Applying a Filter to the Work Pending Screen . . . . . . . . . . . . . . . . . . . . . . . 3-21
Deleting Tests from Work Pending . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-22
Printing the Work Pending Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-23

C73199-AA
3: Sample Manager UniCel DxI Operator's Guide
3.3 Patient Test Requests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25
Test Requests Screen for Patient/QC Samples . . . . . . . . . . . . . . . . . . . . . . . 3-26
Manual Test Requests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-31
Using Auto Sample ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-35
Using Batch Request . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-36
Requesting Service Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-36
Reusing Sample IDs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-37
Adding or Deleting Sample Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-37
Configuring the Automatic Rerun Feature. . . . . . . . . . . . . . . . . . . . . . . . . . . 3-38
3.4 Loading and Unloading Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-40
Attaching Sample Container Bar Code Labels . . . . . . . . . . . . . . . . . . . . . . . 3-41
Placing Sample Containers in Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-42
Using Insert Cups with Sample Tubes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-44
Loading a Rack for Routine Processing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-45
Loading a STAT Rack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-49
Unloading a Rack. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-51
3.5 Monitoring Sample Progress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-54
Sample Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-55
Test Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-55
3.6 Editing Test Requests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-56
Cancelling the Test Requests on a Rack . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-56
Editing a Manual Test Request . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-57
Deleting a Sample from the Test Requests Screen . . . . . . . . . . . . . . . . . . . . 3-59
Changing a Rack ID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-61
3.7 Patient Sample Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . 3-62
Troubleshooting Unexpected Patient Sample Results . . . . . . . . . . . . . . . . . . 3-63
Troubleshooting Patient Sample Results with Increased Variability. . . . . . . 3-65

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UniCel DxI Operator's Guide 3.1: Sample Manager Overview
3.1 Sample Manager Overview
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. If necessary, an
operator can edit test request information on the Test Requests screen.
When the system downloads a test request from the LIS, or if the system cannot
process a test, it adds the test to the work pending list on the Work Pending screen.
For more information, see Section 3.2: LIS Requests and Work Pending.
You place samples with assigned test requests in racks, and then load the racks onto
the sample presentation unit (SPU) (UniCel DxI 800 instrument: see Figure 1-1 in
Section 1.2: Instrument Overview; UniCel DxI 600 instrument: see Figure 1-2). The
system moves the racks to the sample aliquot station, where an aliquot of each sample
is removed and stored for processing. After aliquoting the samples, the system moves
the rack to the offload area.
Some assays require temperature restrictions. See Appendix A of the UniCel DxI
Instructions for Use manual for information on these restrictions.
The system displays sample status information on the Sample Manager screen. Test
status information is displayed on the Test Results screen.
If a sample error occurs, the system turns the Rack Exceptions button yellow. The
associated rack is displayed in the Exceptions field on the Sample Manager screen,
and the sample is displayed on the Exceptions view. The system also displays a
specific error message in the Status field of each Sample Manager view.
If the system cannot process a test because a supply level or calibration condition
exists, one or more system indicators present the necessary information.

C73199-AA
3.1: Sample Manager Overview UniCel DxI Operator's Guide
Query the LIS for test Download test requests from Manually enter test requests
requests the LIS
Sample Manager
(Any Screen)
New Request F3
Patient/QC Requests F1
Work Pending Test Requests
Enter the rack ID and then

Check the screen for test the sample ID, test requests,
requests downloaded and sample information for
from the LIS each sample
Place the requested samples

in racks and load the racks
(sample bar code labels
required for LIS requests)
Monitor sample processing

on the Sample Manager
screen
Yes Are one or

more system
indicators lit?
No
Attend to the supply, Access the Supplies

Continue to monitor sample
calibration, or patient sample Required or Work Pending
processing
condition Screens
3002C.wmf
Figure 3-1 Sample Processing Overview Flowchart

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Sample Use the Sample Manager screen to:

Manager • View sample status information on one of four screen views
Screen • Request new tests for QC and patient, calibration, or maintenance samples
• Edit the test requests on a rack
• Display specific details for a selected rack or sample
2035A.bmp
Figure 3-2 Sample Manager Screen, In Progress View

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2166A.bmp
Sample Manager (Buttons) There are four Screen View buttons. Each button corresponds to a
Screen View specific screen view. For more information, see the Sample Manager Screen Views
Buttons topic.
Select a button to display one of the four Sample Manager screen views. For more
information, see the Selecting a Sample Manager Screen View procedure.
Rack (Column) Displays the ID of the rack on which the sample is loaded.
Rack icon (Requested view only)
(Indicator) Displays the rack ID and the position of each sample
container in the rack.
Pos (Column) Displays the position of the sample in the rack, from 1-4.
Description (Column) Displays a description of the associated sample error.
(Exceptions view
only)
Figure 3-3 Sample Manager Screen Descriptions

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Sample ID (Column) Displays the unique value that identifies one sample from another.
• For patient samples, the sample ID is displayed.
• For QC samples and calibrators, the control or calibrator name is displayed.
• For maintenance samples, the maintenance routine sample type is displayed.
Patient ID (Column) Displays an optional value that identifies the sample being tested.
• For patient samples, the optional patient ID is displayed.
• For QC samples and calibrators, the lot number is displayed.
• For maintenance samples, the maintenance routine sample type is displayed.
NOTE
This column is not displayed on the Exceptions view.
Status (Column) Depending upon the selected screen view, displays the status
information for individual samples, or all samples in a rack. For more information,
see the Sample Status or see the Test Status topics in Section 3.5: Monitoring
Sample Progress.
NOTE
This column is not displayed on the Requested or Exceptions views.
Complete (Column) Displays the estimated completion time for each sample.
NOTE
This column is not displayed on the Requested or Exceptions views.
Creation Time (Column) Displays the time the associated sample error occurred.
(Exceptions view
only)
Sample Aliquot (Field and Icon) Displays the racks that are currently in the sample aliquot station.
Station The aliquot station processes up to four racks at a time. As a rack moves out of the
station, it is removed from the field display and is replaced by another rack. If there
are no racks in the sample aliquot station, the value Empty is displayed in the field.
NOTE
The field displays the order and direction of racks in the aliquot station. It does
not represent the actual location of the racks in station.
Figure 3-3 Sample Manager Screen Descriptions (continued)

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Exceptions (Field and Icon) Displays the racks that contain samples with one or more
exception errors. A sample container with an associated exception is highlighted in
red on the rack icon.
NOTES
• Only containers with an associated exception appear on the rack icon.
• This field is displayed if there is a rack with an associated sample
exception. If there are no exceptions, this area of the Sample Manager
screen is empty.
If there are more than four racks with exception errors, a scroll bar is displayed
next to the field. Racks with exceptions remain in the field for three days. After this
time, they are automatically removed from the field.
You can view the exception information for a specific rack of samples by selecting
the rack icon. The system displays the Exceptions view, and highlights the samples
on the screen. For more information, see the Selecting a Sample Manager Screen
View procedure.
Views (Button) Select to display one of the four Sample Manager screen views. For more
F1 information, see the Selecting a Sample Manager Screen View procedure.
Edit Request (Button) Select to edit a request on the selected rack. The Test Requests screen that
F2 corresponds to the type of request you are editing (patient/QC, calibration,
maintenance) is displayed. From this screen you can edit the test requests for the
entire rack, or for an individual sample. For more information, see
Section 3.6: Editing Test Requests.
NOTE
This button is only available on the Requested or Daily views.
Clear Exceptions (Button) Select to remove a sample from the Exceptions view. For more
F2 information, see the Clearing an Exception from the Exceptions View procedure.
(Only available on
the Exceptions
view)

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New Request (Button) Select to request a new test request. There are three different types of test
F3 requests.
Select to request tests for patient samples and quality controls. For more
information, see the Manual Test Requests procedure in Section 3.3: Patient Test
Requests, or see the Entering QC Test Requests procedure in Section 6.3: Running
Quality Control Tests.
Calibration F2
Select to request an assay calibration. For more information, see the Entering
Calibration Requests procedure in Section 5.3: Running a Calibration.
Maintenance F3
Select to request a maintenance routine. For more information, see the Requesting
Maintenance Routines procedure in Section 7.1: Maintenance Overview.
Test Results (Button) Select to display the Test Results screen. Test requests begin to display on
F4 the Test Results screen when the samples are aliquoted by the system. For more
information, see Section 4.1: Test Results Overview.
Work Pending (Button) Select to display the Work Pending screen. For more information, see
F5 Section 3.2: LIS Requests and Work Pending.
Find (Button) Select to locate a specific sample ID on the Sample Manager screen. For
F6 more information, see the Finding a Sample ID procedure.
NOTE
This button is not available on the Exceptions view.
Details (Button) Select to display detailed information about the tests for a selected
F8 sample. For more information, see the Displaying Test Details procedure.
NOTE
This button is only available on the In Progress or Daily views.

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Sample The Sample Manager screen features four screen views. Each view arranges and
Manager presents sample status information in a specific way. You can select a new screen
Screen Views view at any time. For more information, see the Selecting a Sample Manager Screen
View procedure.
In Progress View
The status information for in progress samples is displayed on the In Progress screen
view. Samples are removed from this view after the instrument generates their test
results.
Requested View
Samples waiting to be processed are displayed on the Requested screen view. The
samples on this view are grouped into their associated racks. Racks are displayed after
you enter them manually, or after the instrument scans each rack. Racks are removed
from this view after all samples in the rack have begun processing.
NOTES
• This view includes a Rack icon for each rack on the screen. The icon displays
the rack ID and position of each sample container. For more information, see
the Sample Manager Screen topic.
• This view does not include the Status and Complete columns.
Daily View
Samples that were processed within a 24-hour time period are displayed on the Daily
screen view. You can change the time period by entering a new date in the field that is
displayed on the Daily button. For more information, see the Entering a Date on the
Daily View procedure.
Exceptions View
Samples with any associated processing errors are displayed on the Exceptions screen
view. Any of the following conditions will generate an exception error.
• Duplicate rack ID
• Duplicate sample ID (on the same rack)
• QNS error for a sample container
• Rack bar code error
• Sample container bar code error
NOTE
Samples with an exception have not been aliquoted by the instrument.
Samples remain on the Exceptions view for three days. After this time, they are
automatically removed from the view.

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Selecting a Use this procedure to select one of the four screen views.
Sample
Manager
From the Sample Manager screen, select the appropriate Screen View button located
Screen View above the rows of sample information. For more information, see the Sample
Manager Screen Views topic.
NOTES
• You can access the Exceptions view from any screen by selecting the Rack
Exceptions button.
• On the Sample Manager screen, racks with one or more exception errors
appear as icons in the Exceptions field. If you select a rack icon, the
Exceptions view is displayed and the samples are highlighted on the screen.
Entering a Use this procedure to display a specific 24-hour time period on the Daily view of the
Date on the Sample Manager screen.
Daily View System Mode: Any Mode
1. From the Sample Manager screen, select the Daily view button to display the
Daily view.
2. Enter the date you wish to view in the field that is displayed on the Daily view
button, and press [Enter].
NOTE
When you enter the date, use the date format that you configured for the system.
For more information, see the Setting the Date and Time Formats procedure in
Section 2.2: System Setup of the Reference Manual.
The status information for the tests requested on that day is displayed.
Clearing an Use this procedure to clear a sample exception from the Exceptions view of the
Exception Sample Manager screen.
from the System Mode: Any Mode
Exceptions 1. From the Sample Manager screen, select the Exceptions button to display the
View Exceptions view.
2. To limit the number of exceptions you will clear, select one sample exception on
the screen, or press and hold the [Ctrl] key as you select more than one exception.
3. Select Clear Exceptions F2.
4. In the Clear Exceptions window, select an option from the Clear What list.

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• To clear the most recent exception only, select Current Exception.

• To clear the exceptions selected on the screen, select Current Selection.
• To clear all of the exceptions on the screen, select All Exceptions.
5. Select OK F1 to clear the exceptions from the screen.
Finding a Use this procedure to find a specific sample ID on the Sample Manager screen.
Sample ID System Mode: Any Mode
NOTES
• The find function is not case sensitive.
• The find function is limited to the samples displayed on the current screen
view. If you are having difficulty finding a specific sample ID, change the
view.
1. From the Sample Manager screen, select Find F6 to display the Find window.
2. In the Find Sample ID field, enter either the complete or partial sample ID of the
sample you intend to find.
3. Select Find F1.
The system highlights the matched sample ID. If no match is found, a message is
displayed.
NOTE
Confirm that the sample ID you entered was correct. If the ID is correct, change
the screen view.
 (Optional) If the system did not match the sample you intend to find, select
Find Next F1 to find the next match to your query. The next match becomes the
selected sample ID.
 (Optional) To find a new sample ID, repeat steps 2 and 3.
4. When you are finished looking for specific samples, select Close F8 to exit the
window.

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Displaying Use this procedure to display test details for a selected sample.
Test Details System Mode: Any Mode
NOTES
• You can only view test details on the In Progress or Daily views.
• If you have difficulty locating a sample, change the screen view or use the
Find function to find the sample ID.
1. From either the In Progress or Daily views of the Sample Manager screen, select
the sample whose test detail information you intend to view.
2. Select Details F8 to display the Test Details window.
2126A.bmp
Sample ID (Field) Displays the ID of the selected sample.

Test Name (Column) Lists the name of the requested tests. Each test replicate
is included in the list.
Comp. Time (Column) Lists the completion time for each test replicate.
Flags (Column) Lists any flags associated with the requested tests.
Figure 3-4 Test Details Window Descriptions
3. When you are finished viewing the test details, select OK F1.
 (Optional) To view the test details for another sample, repeat steps 1-3.

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Resolving Use this procedure to resolve a sample error. You can view all of the samples with an
Sample Errors associated sample error on the Exceptions view of the Sample Manager screen.
1. From the Sample Manager screen, select the Exceptions button to display the
Exceptions view.
2. Review the error message displayed in the Status column.
3. Take the necessary action to resolve the sample error. For more information, see
Section 3.7: Patient Sample Troubleshooting.
4. Once you have performed the necessary troubleshooting steps, select the sample
on the Exceptions view and then Clear Exception F2.
The sample and error message are removed from the Exceptions view.
5. Reload the sample.

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UniCel DxI Operator's Guide 3.2: LIS Requests and Work Pending
3.2 LIS Requests and Work Pending
LIS requests are processed by host query or by downloading from the laboratory
information system (LIS). Select the method for your system on the LIS Setup
window during system configuration. For more information, see Section 2.5: LIS
Setup in the Reference Manual. For downloaded requests, the system displays the
pending tests on the Work Pending screen. The tests remain on the screen until you
load the missing samples onto the instrument.
NOTES
• A test request with an associated sample dilution factor will not be placed on
the Work Pending screen. The system records an event in the Event Log,
which instructs you to request the sample manually and add the correct
dilution factor from the Test Request screen. For more information, see
Section 3.3: Patient Test Requests.
• If you use a Patient ID in a manual test request, the UniCel DxI system will
evaluate the manually requested results against default ranges even if your
laboratory has defined different ranges (reference, critical, and/or LIS) based
on demographics. For more information, see Section 3.4: Ranges Setup in the
Reference Manual.
The Work Pending screen lists all the tests that the UniCel DxI system cannot process
because samples are missing. The system turns the Work Pending button yellow
when it adds a test to the work pending list. You resolve items on the list by loading
samples or manually deleting tests from the list.
Pending tests for the following kinds of missing samples are displayed on the Work
Pending screen.
• A missing sample for a test downloaded from the LIS or for a manual test
request. For more information, see Section 3.3: Patient Test Requests.
• A sample without enough reserve volume to process a reflex test or a test
rerun from the Test Results screen. For more information, see Section 3.7:
Reflex Test Setup of the Reference Manual.
• A sample without enough reserve volume to process an automatic rerun test
request.
• A sample that the system did not process because the sample had expired.

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3.2: LIS Requests and Work Pending UniCel DxI Operator's Guide
• A sample that the system did not aliquot because there was not enough
volume.
• A sample that the system did not aliquot because it contained a clot or some
other type of obstruction.
• A sample that is missing or that the system did not aliquot for an unspecified
reason.
The Work Pending screen is updated in real time when a test on the screen is assigned
to a sample, or when test requests are downloaded from the LIS. You can refresh the
screen by selecting the Work Pending button.
Work Pending You use the Work Pending screen to:

Screen • Identify the samples with pending test requests, and the reason they are in
Work Pending
• Identify the test requests downloaded from the LIS
• Delete pending test requests
• Configure automatic rerun requests
• Print the Work Pending Report
2092D.bmp

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Tests Requested (Field) Displays the total number of tests in the work pending list that meet the filter
parameters.
LIS Workpool (Field) Displays the number of tests in the work pending list that were downloaded
from an LIS.
NOTE
Apply the LIS Request filter option to view the number of tests in the LIS
Workpool. If the filter is not applied, the number in this field will always be 0.
For more information, see the Applying a Filter to the Work Pending Screen
procedure.
Sample ID (Column) Displays the sample ID for each sample in the work pending list.
Patient ID (Column) Displays the required patient ID for LIS requests, or the lot number for
QC requests.
Requested (Column) Displays the date and time of the original test request.
Tests Pending (Column) Displays the names of the tests that are pending. Each test name is
displayed in a separate row.
Origin (Column) Displays the origin of the test request in the work pending list.
(Rack/Instrument) • Reflex - The system initiated a reflex test and there was insufficient reserve
volume to process the request.
• Manual Rerun - The operator requested that a test be rerun and there was
insufficient reserve volume to process the request.
• Automatic Rerun - The system requested that a test be rerun and there was
insufficient reserve volume to process the request.
• LIS - The LIS requested a test or reflex test and there was not enough sample to
process the request, or the sample was not on board.
• Sample Expired - The system did not process the sample because the sample was
expired.
• QNS - The system did not aliquot the sample because there was not enough
volume.
• Obstruction - The system did not aliquot the sample because there was a clot or
some other type of obstruction.
• Other - The test is pending for any reason other than those defined above.
The rack ID associated with the sample is displayed in parentheses. If the sample is
not associated with a rack, the Rack ID is left blank. The Instrument ID, in
parentheses with the Rack ID, is not used by the system and will always display
Unknown.
Filter (Button) Select to change the filter parameters and sort order for the Work Pending
F1 screen. The applied filter and sort order displays in the Filter field. For more
information, see the Applying a Filter to the Work Pending Screen procedure.

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Sample Manager (Button) Select to display the Sample Manager screen. For more information, see the
F2 Sample Manager Screen topic in Section 3.1: Sample Manager Overview.
Delete (Button) Select to delete tests from the work pending list. For more information, see
F6 the Deleting Tests from Work Pending procedure.
Print (Button) Select to print the Work Pending Report. For more information, see the
F7 Printing the Work Pending Report procedure.
Options (Button) Select to display the Options window. From the Options window, you can
F8 configure the system to automatically rerun tests that are cancelled due to system
errors. For more information, see the Configuring the Automatic Rerun Feature
procedure.
Downloading Use this procedure to process test requests downloaded from the LIS. When you load
LIS Test bar coded sample containers for the tests listed on the Work Pending screen, the
Requests system matches the downloaded test requests to the samples and runs the tests.
NOTES
• When downloading test requests, be sure that LIS host query is not enabled.
For more information, see Section 2.5: LIS Setup in the Reference Manual.
• When setting up new tests to run on the instrument, enable the tests before
downloading test requests from the LIS. The system rejects test requests for
tests that are not enabled. For more information, see Section 3.1: Configuring
Tests and Results Overview in the Reference Manual.
1. From any screen, select the Work Pending button to display the Work Pending
screen.
2. Review the LIS Workpool field and the list of tests displayed on the screen for
test requests the system has downloaded from the LIS.
NOTE
Be sure that LIS requests are included in the applied filter. For more information,
see the Applying a Filter to the Work Pending Screen procedure.

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3. Place the bar coded sample containers for the samples and tests listed on the
screen in racks. For more information, see the Placing Sample Containers in
Racks procedure in Section 3.4: Loading and Unloading Racks.
NOTES
• Place only containers for samples listed on the screen in a rack. If the system
cannot match a sample ID bar code to an ID in the workpool, the system will
not remove an aliquot for processing.
• If you are placing sample containers in a rack that is designated for reserve
volume, be sure that the sample containers contain enough sample volume to
provide the reserve volume. For more information, see the Calculating
Minimum Sample Volume procedure in Section A.2: Sample Containers.
4. Load the racks. For more information, see the Loading a Rack for Routine
Processing procedure. Load any racks that contain STAT samples first. For more
information, see the Loading a STAT Rack procedure in Section 3.4: Loading and
Unloading Racks.
5. The system scans the racks and sample container bar code labels, and updates the
Sample Manager screen. For more information, see Section 3.1: Sample Manager
Overview.
(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
2095C.wmf
Figure 3-5 Downloading LIS Test Requests Flowchart

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Querying the Use this procedure to query the laboratory information system (LIS) for test requests.
LIS for Test
Requests
NOTES
• Be sure that LIS host query is enabled. For more information, see
Section 2.5: LIS Setup in the Reference Manual.
• 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. For more information, see Section 3.1:
Configuring Tests and Results Overview in the Reference Manual.
1. Place the bar coded sample containers in racks. For more information, see the
Placing Sample Containers in Racks procedure in Section 3.4: Loading and
Unloading Racks.
NOTE
If you are placing sample containers in a rack that is designated for reserve
provide the reserve volume. For more information, see the Calculating Minimum
Sample Volume procedure in Section A.2: Sample Containers.
2. Load the racks. For more information, see the Loading a Rack for Routine
Processing procedure in Section 3.4: Loading and Unloading Racks. Load any
racks that contain STAT samples first. For more information, see the Loading a
STAT Rack procedure.
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. For more information, see Section 2.5: LIS Setup in the Reference
Manual.
• 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.
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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Applying a The work pending filter is a set of parameters that you can apply to designate the
Filter to the kinds of test requests to be displayed on the Work Pending screen.
Work Pending Use this procedure to apply different filter parameters or a different sort order to the
Screen Work Pending screen.
NOTE
The Work Pending button turns yellow when a test request sample that meets the
applied filter parameters is added to the work pending list.

1. From the Work Pending screen, select Filter F1 to display the Filter window.
2139C.bmp
Filter (Boxes) Select one or more kinds of pending test requests to

include in the filter.
Sort Order (Option) Select the attribute by which the pending tests are sorted
on the screen.
Ascending (Box) Select to sort the pending tests in ascending order by
request time or sample ID, or clear to sort the tests in descending
order by request time or sample ID.
Figure 3-6 Filter (Work Pending) Window Descriptions

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2. Select one or more of the pending test request options to include in the filter, or
clear to remove a selection from the filter.
 (Optional) Select a Sort Order option.
 (Optional) Select or clear the Ascending option.
3. Select OK F1. The Work Pending screen displays all pending tests that meet the
selected filter parameters.
Deleting Tests Use this procedure to delete pending tests displayed on the Work Pending screen.
from Work
Pending
1. On the Work Pending screen, locate and select the tests you intend to delete from
the work pending list.
 (Optional) To reduce or expand the test requests that are displayed on the Work
Pending screen, change the filter parameters. For more information, see the
Applying a Filter to the Work Pending Screen procedure.
2. Select Delete F6 to display the Delete window.
The Current Test option is selected in the Delete what list.
2140A.bmp

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Delete (Option) Select the tests that you will delete from the Work
What Pending screen.
• Current Test - Select to delete the test you selected on the
work pending list.
• Selected Tests - If you selected more than one test on the
work pending list, select to delete each of the tests. This
option is not available if you only selected one test on the list.
• All Tests in Filter - Select to delete all of the tests that meet
the applied filter parameters.
Figure 3-7 Delete (Work Pending) Window Descriptions
3. Select one of the Delete what options.
4. Select OK F1 to delete the test or tests from the work pending list.
A confirmation window is displayed.
5. Select Yes F1 to confirm your selection.
Printing the Use this procedure to print the Work Pending Report, which lists the pending test
Work Pending requests that meet the applied filter parameters.
Report System Mode: Any Mode
1. On the Work Pending screen, confirm that the tests you intend to print are
displayed in the applied filter.
 (Optional) To reduce or expand the kinds of tests to print, or to change the sort
order, apply a new filter to the Work Pending screen. For more information, see
the Applying a Filter to the Work Pending Screen procedure.
2. Select Print F7 to print the Work Pending Report.

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Laboratories, Inc.
Work Pending Report Laboratory A
S/N 654321 101-555-2323 ext. 109 Jane Smith
Filter: Reflex Tests, Manual Rerun, LIS Requests, Sample Expiration, Insufficient Sample Volume, Other
Tests Requested: 6
LIS Workpool: 4
Sample ID Patient ID Requested Tests Pending Origin (Rack/Instrument)

80140-0055 651923376 10/10/03 08:12:09 AM TSH LIS (Unknown)
80140-0061 834770845 10/10/03 08:50:34 AM Prog LIS (Unknown)
80140-0099 661030189 10/10/03 10:03:11 AM TSH Manual Rerun (Unknown)
80140-0102 750112726 10/10/03 12:15:55 PM hLH Reflex (Unknown)
Page 1 of 1
2147D.bmp
Figure 3-8 Work Pending Report Example

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UniCel DxI Operator's Guide 3.3: Patient Test Requests
3.3 Patient Test Requests
A patient test request includes a unique sample ID, sample information such as patient
ID and processing priority, and an assigned test, or list of tests, to be run on the
UniCel DxI system.
In most cases, the system queries a laboratory information system (LIS) for patient
sample and test request information, or downloads the information from the LIS. For
more information, see Section 3.2: LIS Requests and Work Pending. Patient sample
and test request information that does not originate from an LIS is manually entered
on the Test Requests screen. If necessary, the test list or patient sample information
can also be edited on this screen. For more information, see Section 3.6: Editing Test
Requests.
System errors can cause the cancellation of tests and prevent the system from
calculating a result. The system can be configured to automatically rerun some
cancelled patient and control tests. For more information, see the Configuring the
Automatic Rerun Feature topic.
Calibration, QC, and maintenance test requests are entered manually on the Test
Requests screen. For more information, see Section 5.3: Running a Calibration, see
Section 6.3: Running Quality Control Tests, or see Section 7.1: Maintenance
Overview.
NOTE
Manually requested patient test results are evaluated against default ranges, even
if your laboratory has established reference, critical, or LIS ranges. For more
information, see Section 3.4: Ranges Setup in the Reference Manual.

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3.3: Patient Test Requests UniCel DxI Operator's Guide
Test Requests Use the Test Requests screen to:

Screen for • Enter manual test requests.
Patient/QC • Enter test requests for calibration and quality control samples. For more
Samples information, see Section 5.3: Running a Calibration, or see
Section 6.3: Running Quality Control Tests.
• Edit or delete test requests.
2068D.bmp
Rack Button (Button and Field) Displays the rack ID, and the position and sample ID of each
and container in the rack.
Enter ID Select the Rack button to enter or change the rack ID. The Enter ID field is
displayed.
Auto Sample ID (Indicator) When the Auto Sample ID option is on, the indicator displays above the
sample information. When the Auto Sample ID option is off, the indicator is not
displayed. For more information, see the Using Auto Sample ID procedure.
Figure 3-9 Test Requests Screen Descriptions for Patient/QC Samples

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Batch Request (Indicator) When the Batch Request option is on, the indicator displays above the
sample information. When the Batch Request option is off, the indicator is not
displayed. For more information, see the Using Batch Request procedure.
Position (Buttons) Select a numbered position to enter or edit sample information for the
sample in that position in the rack. The positions in a rack are arranged numerically
from 1-4, as displayed on the Rack button.
The sample information fields for a specific sample are available for entry when its
corresponding Position button is selected. You can enter or change the information
in any field until the system scans the rack.
Sample ID (Field) Displays the unique value that identifies one sample from another.
• For manual test requests, enter the sample ID in this field.
• For QC test requests, select Request QC F5 to enter a control ID in this field.
The tests requested for the sample are displayed beneath the sample ID. If the test
list is too long to fit in the field, ... is displayed.
Patient ID/Lot (Field) Displays an optional value that identifies the patient whose sample is being
Number tested. If you enter a quotation mark ("), characters to the right of the quotation
mark may not print on reports.
• For manual test requests, enter the patient ID in this field.
NOTE
A patient ID is required for LIS test requests.
• For QC test requests, the system enters the control lot number in this field when
you select a control from the Request QC window.
Dilution (Field) Displays the dilution factor for a manually diluted sample. The default
value is 1. The acceptable dilution range is from 1 (no dilution, 1:1) to 999.
• For manual test requests, change the default dilution factor if necessary.
• For QC test requests, this field is not available.
Sample Type (Field) Displays the sample fluid type.
• For manual test requests, change the sample type if necessary.
• For QC test requests, the system displays the sample type entered during setup.
Figure 3-9 Test Requests Screen Descriptions for Patient/QC Samples (continued)

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STAT (Box) Displays the sample priority. The default value is routine priority (box not
selected).
• For manual test requests, select the box to process a patient sample with STAT
priority (before all other samples), or clear the box to process the sample with
routine priority.
NOTE
Confirm that all tests requested for a STAT sample have an active assay
calibration listed on the Calibration screen. For more information, see the
Calibration Screen topic in Section 5.1: Assay Calibration Overview.
• For QC test requests, the STAT box is not available.

A rack containing a sample with STAT priority should be loaded as a STAT rack.
For more information, see the Loading a STAT Rack procedure in Section 3.4:
Loading and Unloading Racks.
Comment (Pen or Notepad Button) Displays any comments associated with the sample.
For manual and QC test requests, select the button to display the Sample Comment
window and add, edit, or delete sample comments. For more information, see the
Adding or Deleting Sample Comments procedure.
If there are no comments associated with a sample, the Pen button is

displayed.
If a comment has been entered for a sample, the Notepad button is

displayed.
The system displays sample comments on test result reports and on the Quality
Control screen and reports.
Tests Requested (Field) Displays a list of all the tests requested for a selected sample (X is the
for Sample X selected sample position). Test replicates are displayed as a number in parentheses
after the test name. For quality control samples, the system displays the reagent lot
number in parentheses after the test name if you use the Change Reag. Lot button
to specify a reagent lot for the control.
For manual and QC test requests, you can use the Test buttons to add or delete tests
from the test list. For more information, see Section 3.6: Editing Test Requests.
Test (Field) Displays the test ID for the selected test.
• To add a replicate, press the [+] key.
• To remove a replicate, press the [-] key.

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Test Buttons (Buttons) Displays the test name and ID for each available test or test panel, sorted
by test number. Select a button to add one test, or one replicate of each test in a test
panel, to the Tests Requested for Sample X list.
The test buttons that display depend on the currently selected sample tube. If
available, test panel button names are displayed in bold blue, and onboard dilution
test button names are displayed in blue.
Remove (Button) Select to remove one replicate of the selected test in the Tests Requested
for Sample X list.
Rack ID (Button) Select to enter a new rack ID, or change the current rack ID. The Enter ID
F1 field is displayed on the Rack button. For more information, see the Manual Test
Requests procedure or see Section 3.6: Editing Test Requests.
Delete Sample (Button) Select to delete the sample selected on the Test Requests screen. For more
F2 information, see Section 3.6: Editing Test Requests.
New Request (Button) Select to exit this request and to request a new test request. There are three
F3 different test request types.
information, see the Manual Test Requests procedure, or see the Entering QC Test
Requests procedure in Section 6.3: Running Quality Control Tests.
Calibration F2
Maintenance F3
Maintenance Routines procedure in Section 7.1: Maintenance Overview.
Test Results (Button) Select to display the Test Results screen. Test requests begin to display on
F4 the Test Results screen when the samples are aliquoted by the system. For more
information, see Section 4.3: Reviewing Test Results.
Request QC (Button) For quality control samples, select to display the Request QC window.
F5 For more information, see Section 6.3: Running Quality Control Tests.
If the selected sample position contains a patient sample, the system displays an
error message.
Cancel Request (Button) Select to cancel the test request and to return to the Sample Manager
F6 screen. For more information, see Section 3.6: Editing Test Requests.
Clear All Samples (Button) Select to clear the sample information for each sample on the selected
F7 rack.

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More Options (Button) Select to display a menu of the following options:

F8 Turn Batch Request On/Off F1
Select to turn the Batch Request option on or off. For more information, see the
Using Batch Request procedure.
Turn Auto Sample ID On/Off F2
Select to turn the Auto Sample ID option on or off. For more information, see the
Using Auto Sample ID procedure.
Request Service Assay F3
Use this function only as directed by Technical Support.
Manual Test Use this procedure to manually enter patient test requests that do not originate from
Requests the LIS.
NOTES
• Do not enter a quotation mark (") in an available field. If you do, characters
to the right of the quotation mark may not print on reports.
• Manually requested patient test results are evaluated against default ranges,
even if your laboratory has established reference, critical, or LIS ranges. For
more information, see Section 3.4: Ranges Setup in the Reference Manual.
1. From the Sample Manager screen (see Figure 3-3 in Section 3.1: Sample
Manager Overview), select New Request F3.
2. Select Patient/QC Requests F1 to display the Test Requests screen.
3. Enter the rack ID in the Enter ID field and press [Enter].
NOTE
The system will reject the rack ID if the ID is not set up for your system. For more
information, see the Setting Up Rack IDs procedure in Section 2.3: Supplies
Setup of the Reference Manual.
4. Enter the sample ID in the Sample ID field and press [Enter].
NOTES
• The sample ID can be up to 15 characters long. The system accepts the
following characters: 0-9, A-Z, a-z, /, +, and -. The system does not accept
spaces, punctuation marks, or special characters in this field.
• When the rack is loaded, the system compares the manually requested ID to
the sample container bar code, if present. If the sample IDs do not match, the

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sample is not aspirated. The request is displayed on the Exceptions view of

the Sample Manager screen, and an event is recorded in the Event Log.
 (Optional) If you are entering samples with consecutive sample IDs, turn the
Auto Sample ID option on. For more information, see the Using Auto Sample ID
procedure.
 (Optional) If the sample has an associated patient ID, enter it in the Patient ID
field and press [Enter].
NOTE
The patient ID can be up to 15 characters long. The system accepts any character
in this field.
5. Select the tests that you will run on the sample by selecting their corresponding
Test buttons. To run a replicate of a test, select the Test button again.
The number of additional replicates are displayed in parentheses to the right of the test
name in the Test Requested for Sample X list.
 (Optional) If you are requesting confirmatory tests, use one of the following
methods:
• Request the screening and confirmatory tests at the same time, so that the samples
for each test are aspirated from the same sample container. For more information
about confirmatory tests, see Section 1.5: Confirmatory Assay Theory in the
Reference Manual.
• Request the screening test only. However, before doing this, enable an adequate
reserve volume and set up a reflex condition to automatically run the
confirmatory tests if the test result is reactive. For more information, see the
Setting Up Reserve Volume procedure in Section 3.7: Reflex Test Setup of the
Reference Manual.
 (Optional) If you will run the same tests on subsequent samples, turn the Batch
Request option on. For more information, see the Using Batch Request
procedure.
 (Optional) To remove a requested test or one of its replicates, select the test in the
Tests Requested for Sample X list and then select Remove.
6. Review the values in the following fields and change them if necessary.
a. Dilution: Enter a dilution factor for a manually diluted sample.

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NOTES
• To change the dilution factor, enter a whole number. The acceptable dilution
range is from 1 (no dilution, 1:1) to 999 (1:999 dilution). The system does not
accept other entries, such as 1/3 or 3:1.
• You cannot enter a manual dilution factor for an onboard dilution test.
b. Sample Type: If the sample type does not match the sample type set up for
the test, select a type from the option list.
c. STAT: Select the box to assign the STAT priority to the sample.
NOTE
If you assign the STAT priority to a sample, confirm that each requested test has
an active calibration on the Calibration screen For more information, see the
d. Comment: Select the Pen or the Notepad button to display the Comment
window. For more information, see the Adding or Deleting Sample
Comments procedure.
 (Optional) To enter additional test requests for the same rack, select a new sample
row and repeat steps 4-6.
7. Confirm that the sample and test request information entered on the Test Requests
screen is correct.
 (Optional) If you requested STAT samples for the rack, place the containers in
the rack and load the rack immediately. For more information, see the Placing
Sample Containers in Racks and see the Loading a STAT Rack procedures in
Section 3.4: Loading and Unloading Racks.
NOTE
 (Optional) To enter additional test requests for a new rack, select

New Request F3 and repeat steps 2-7.
8. Select the Back tab to exit the Test Requests screen.

9. Place the sample containers in racks. For more information, see the Placing
Sample Containers in Racks procedure in Section 3.4: Loading and Unloading
Racks.

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NOTE
Load the racks. For more information, see Section 3.4: Loading and Unloading Racks.
Sample Manager
New Request F3
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
2096C.svg
Figure 3-10 Manual Test Requests Flowchart

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Using Auto The Auto Sample ID option automatically assigns sequential sample IDs during
Sample ID manual test request entry. This feature is typically used when your laboratory needs to
perform a correlation study or method comparison for an updated assay.
Examples
• If the first sample ID ends with a numeric character, Sample1, the subsequent
sample IDs are Sample2, Sample3, and so on.
• If the first sample ID ends with a non-numeric character, SampleA, the
subsequent sample IDs are SampleA1, SampleA2, and so on.
Use this procedure to turn the Auto Sample ID option on and off.

1. On the Test Requests screen, enter the sample ID for the first sample. For more
information, see the Manual Test Requests procedure.
CAUTION
When using the Auto Sample ID option, the first sample ID must be less than
the allowed 15 characters. The sequential characters added for an Auto
Sample ID are included in the 15 character maximum. If a sample ID
exceeds 15 characters, a system error will occur when the rack is loaded.
2. Select More Options F8, and then select Turn Auto Sample ID On F2.
3. Select the next sample position. The system automatically enters the next
incremental sample ID in the Sample ID field.
 (Optional) To change the sample ID sequence, select the Sample ID field and
enter a new ID.
4. Continue entering test request information for all remaining samples.

The system continues to supply an incremented sample ID for each sample until you
turn off the Auto Sample ID option or exit the Test Requests screen.
 (Optional) To turn the Auto Sample ID option off, select More Options F8, and
then select Turn Auto Sample ID Off F2.
 (Optional) To use the Auto Sample ID option to enter test requests on a new rack,
select New Request F3 and continue entering test request information.
5. When you are done entering test requests, exit the Test Requests screen.
The system automatically turns the Auto Sample ID option off.

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Using Batch The Batch Request option automatically assigns the same test list from the previous
Request sample to the next sample.
Use this procedure to turn the Batch Request option on and off.

1. On the Test Requests screen, enter the sample ID, sample information, and tests
to run for the first sample. For more information, see the Manual Test Requests
procedure.
2. Select More Options F8, and then select Turn Batch Request On F1.
3. Select the next sample position and enter the sample ID.
The system automatically assigns the same test list when you begin entering
information in another field.
4. Continue entering test request information for all remaining samples.

The system continues to select the same test list for each sample until you turn off the
Batch Request option or exit the Test Requests screen.
 (Optional) To turn the Batch Request option off, select More Options F8, and
then Turn Batch Request Off F1.
 (Optional) To use the Batch Request option to enter test requests on a new rack,
select New Request F3 and continue entering test request information.
5. When you are done entering test requests, exit the Test Requests screen.
The system automatically turns the Batch Request option off.
Requesting Your technical support representative may use service assays for instrument
Service diagnostics.
Assays
NOTE
Use this function only as directed by your technical support representative.

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Reusing Patient samples are identified by a unique sample ID. For 30 days after a patient test
Sample IDs request is entered on the system, a request that includes the same sample ID is
automatically associated with the sample in the original test request. If the sample ID
is inactive for 30 days or more, the system accepts the ID as a unique identifier again.
If you need to reuse a sample ID within 30 days, all of the test request information
about the previous sample ID must be removed from the system. Use this procedure to
remove the sample ID information.
System Mode: Varies for Different Steps of the Procedure

1. Delete all of the test results associated with the sample ID. For more information,
see Section 4.4: Managing Test Results. To configure the system to automatically
delete test results, see the Setting Up the Auto-Delete Feature procedure in
Section 2.6: Data Management of the Reference Manual.
2. Be sure that each test you request for the reused sample ID is enabled. For more
information, see Section 3.3: Test Setup in the Reference Manual.
3. Delete all work pending tests associated with the sample ID. For more
information, see the Deleting Tests from Work Pending procedure in Section 3.2:
LIS Requests and Work Pending.
Adding or Use this procedure to enter, edit, or delete sample comments on the Test Requests
Deleting screen.
Sample System Mode: Any Mode
Comments 1. Select the Pen or the Notepad button to display the Sample Comment window.
The pen indicates no comments are associated with the sample.
The notepad indicates comments are associated with the sample.
2. In the Comment field, enter or edit comments. Or, to delete an existing comment,
select it and press the [Backspace] key.
3. To save your comments or changes, select OK F1.

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Configuring Use this procedure to configure the system to automatically rerun patient and control
the Automatic tests that are cancelled due to system errors characterized by the fatal flags listed
Rerun Feature below. For more information, see the Test Result Flags and Troubleshooting topic in
Section 4.3: Reviewing Test Results.
• CLT • QNS • QSB • QSD • QSS
• RLU • SYS • TRI • TRS • TRW
If sufficient reserve volume is onboard the instrument when an automatic request is

made, the test runs immediately. For more information, see the Setting Up Reserve
Volume topic in Section 3.7 of the Reference Manual. If sufficient reserve volume is
not onboard at the time of the automatic request, the request is added to Work
Pending. For more information, see Section 3.2: LIS Requests and Work Pending.
NOTES
• The automatic rerun feature is not available on integrated workstations.
• Tests for manually diluted samples are rerun only if sufficient reserve volume
is onboard when the automatic request is made. If sufficient reserve volume
is not onboard, the request is not added to Work Pending.
• If a test is cancelled due to a reagent pipettor error, the system attempts to
automatically rerun the test using a different pipettor. If the test is configured
for only one pipettor, the test is run on the same pipettor.
• The automatic rerun feature does not apply to confirmatory tests. A cancelled
confirmatory test and the qualitative test it is paired with must be requested
manually.

1. From the Sample Manager screen (see Figure 3-3 in Section 3.1: Sample
Manager Overview), select Work Pending F5.
2. Select Options F8 to display the Options window.

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2352A.bmp
Rerun cancelled (Box) Select to enable the system to automatically rerun

tests automatically cancelled patient and control tests.
Figure 3-11 Options (Work Pending) Window Description
3. Select the Rerun cancelled tests automatically box to enable the automatic
rerun feature, or clear the box to disable the automatic rerun feature.
4. Select OK F1.

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UniCel DxI Operator's Guide 3.4: Loading and Unloading Racks
3.4 Loading and Unloading Racks
The UniCel DxI system uses four different rack sizes. Each rack holds a specific type
of sample container. Racks include rack ID and sample container type labels to help
identify each type of rack. You configure the types of sample containers that are
accepted for a range of rack IDs on the System Setup screen. For more information,
see Section 2.2: System Setup in the Reference Manual.
You place sample containers in the appropriate racks, and then load the racks in the
onload area of the sample presentation unit (SPU). The onload area of the
UniCel DxI 800 instrument holds approximately 30 racks. The onload area of the
UniCel DxI 600 instrument holds approximately 15 racks. The system moves the
racks to the sample aliquot station, where an aliquot of each sample is removed for
processing. When all samples in a rack are aliquoted, the system moves the rack to the
offload area of the SPU. You can unload racks from the offload area at any time.
WARNING
You will come in contact with potentially infectious materials when following
these procedures. Handle and dispose of biohazard materials according to
proper laboratory procedures. Proper hand, eye, and facial protection is
required.
You can monitor the status of samples in a rack on the Sample Manager screen. For
more information, see Section 3.5: Monitoring Sample Progress.

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3.4: Loading and Unloading Racks UniCel DxI Operator's Guide
Attaching Use this procedure to attach a bar code label on a sample container.
Sample
WARNING
Container Bar
Code Labels You will come in contact with potentially infectious materials during this
NOTE
The internal bar code reader automatically discriminates between symbologies,
so that samples with bar code labels using different symbologies can be included
on the same rack. You may need to enable parameters for the bar code
symbologies that you use. For more information, see Section 2.4: SPU Bar Code
Reader Setup in the Reference Manual.
1. Place the bar code label on the sample container so that the label is at least
0.4 inches (10 mm) from the top and bottom of the container. Be sure that it is
securely fastened.
2. When you place the sample container in the rack, be sure the sample bar code
label is centered in the opening slot of its rack position for accurate scanning.
1
ABC123456789
ABC123456789
2199A.eps
1 Minimum distance = 0.4 inches or 10 mm

2 Minimum distance = 0.4 inches or 10 mm
Figure 3-12 Sample Bar Code Label Placement

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Placing Use this procedure to place sample containers in a labeled rack.

Sample
WARNING
Containers in
Racks You will come in contact with potentially infectious materials during this
CAUTION
Remove caps from all sample containers before loading on the UniCel DxI
system.
NOTE
Do not place an insert cup in a rack. Place insert cups inside a sample container.
For more information, see the Using Insert Cups with Sample Tubes procedure.
1. Be sure that there is a sufficient volume of sample in the sample container to

process all of the requested tests. To calculate the correct sample volume, see
Section A.2: Sample Containers.
NOTE
If you are transferring sample to a new sample container, carefully pipette the
sample into the sample container or insert cup. Avoid creating air bubbles.
WARNING
Use the rack identifier, and the container type and rack ID labels to locate the
correct rack in the following step. If you place a sample container in an incorrect
rack, you may damage the system or compromise the integrity of your test
results.
2. Locate the appropriate rack for the sample container (as indicated by the rack ID
number and label). If you do not intend for the system to draw a reserve, be sure
to place the container in a rack identified with the No Reserve Volume label. For
more information, see the Setting Up Rack IDs procedure in Section 2.3: Supplies
Setup of the Reference Manual.
WARNING
In the following step, if you are manually entering test requests for sample
containers with no bar code labels, be sure to place the sample containers in the
positions you specified on the Test Requests screen. If the containers are not
placed in the designated positions, the system will report incorrect test results.

C73199-AA
3. Place the sample container in the rack. Be sure the sample bar code label is in
good condition, and is properly affixed to the container. When you place the
container in a rack, the label should be visible through the slot.
NOTE
Be sure to use supported sample bar code symbologies, and to configure the
internal bar code reader appropriately. For information, see Section 2.4: SPU Bar
Code Reader Setup in the Reference Manual.
2
ABC123456789
3
2
1
2152A.eps
R
1 Sample container
2 Sample container bar code label
3 Rack slot
Figure 3-13 Loading a Sample Container in a Rack
4. After you have placed all of the sample containers in the rack, you can load the
rack onto the onload area of the SPU for either routine or STAT processing. For
more information, see the Loading a Rack for Routine Processing or see the
Loading a STAT Rack procedures.

C73199-AA
Using Insert An insert cup has a smaller dead volume than a sample tube. You may need to transfer
Cups with sample from a sample tube to an insert cup to meet the total sample volume required
Sample Tubes for testing.
Use this procedure if you are using an insert cup on the instrument.
WARNING
1. Transfer the required sample volume from the sample tube into an insert cup. Be
sure that there is a sufficient volume of sample to process all of the requested
tests. To calculate the correct sample volume, see Section A.2: Sample
Containers.
NOTE
Carefully pipette small sample volumes into the insert cup to prevent air bubbles
from forming at the meniscus.
2. Place the insert cup back into the original sample tube.
3. Place the sample tube into a rack. For more information, see the Placing Sample
Containers in Racks procedure.
2
ABC123456789
2141A.eps
1 Insert cup
2 Sample tube
Figure 3-14 Loading an Insert Cup

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Loading a Use this procedure to load a rack containing routine samples onto the instrument. If
Rack for you are loading a rack containing STAT samples, see the Loading a STAT Rack
Routine procedure. You load racks onto the onload area of the SPU.
Processing WARNINGS
• Do not place your hand inside of the sample aliquot station.
NOTES
• Each loaded rack must have a rack ID that is set up for your system. A rack
loaded with an ID that was not set up will pass through the system without
being processed. For more information, see the Setting Up Rack IDs
procedure in Section 2.3: Supplies Setup of the Reference Manual.
• Be sure that the rack ID bar code label is in good condition and is properly
affixed to the rack. For more information, see Section 2.3: Supplies Setup in
the Reference Manual.
• You can reuse a rack after it is aliquoted by the system. You cannot have two
racks with the same rack ID in the onload area of the SPU.
• Do not load a rack while the utility routine is running.
System Mode: Ready Running
WARNING
In the following step, if your sample containers do not have bar code labels, be
sure to place the sample containers in the positions you specified on the Test
Requests screen. If the containers are not placed in the designated positions, the
system will report incorrect test results.
1. Place the sample containers for the requested tests in a rack. For more
information, see the Placing Sample Containers in Racks procedure.
2. Check the status of the onload pusher motion indicator.

Off: The cover is not locked. You can load racks.
On: The system is pushing one or more racks into position and the cover is locked.
Select the Routine button and wait until the system unlocks the cover.
The system aliquots the current sample container, moves the onload pusher to the
home position, and unlocks the SPU cover.

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3
1 4
2
LOAD LOAD
ROUTINE STAT
5
2182C.eps
1 SPU cover
2 Routine button
3 Load lights
4 STAT button
5 Onload pusher motion indicator
Figure 3-15 SPU Cover and Load Button Locations
3. Open the SPU cover.
CAUTION
In the following step, be sure the bar code label is on the right side of the
rack. If the rack is loaded incorrectly, it may jam on the SPU or pass through
without being aliquoted.
4. Place the rack in the onload area of the SPU. Place the rack to the right of any
racks in the onload area. Be sure the bar code label is on the right side of the rack,
and the rack arms rest over the guide rails on either side of the onload area.
 (Optional) If you have additional racks to load, repeat step 4.

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4
6
3
2
5
1
51
0
2
4
3
1
2150B.eps
1 Guide rails
2 Rack correctly loaded, with bar code facing to the right
3 Rack ID label side of the rack, with the rack arm on the guide rail
4 Front onload area of the SPU
5 End of the onload sensor
6 Presentation tray gate in the sample presentation area (gate is up)
Note: The tray gate shown is for the UniCel DxI 800 instrument.
7 Sample aliquot station (with the sample presentation tray inside)
Figure 3-16 Rack Correctly Loaded in the SPU
5. Close the SPU cover.

The system pushes the rack to the sample aliquot station.

C73199-AA
Place the sample containers

for the requested tests in a
rack
Check the status of the

sample presentation unit
(SPU) cover sensor
Select the Routine button

No
Is the sensor off? and wait until the system
unlocks the cover
Yes
Open the SPU cover
Place the rack in the SPU

onload area
Close the SPU cover
3000C.wmf
Figure 3-17 Loading a Rack for Routine Processing Flowchart

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Loading a Use this procedure to load a rack that contains a STAT sample. You can load a STAT
STAT Rack rack ahead of racks previously loaded for routine sample processing.
WARNINGS
• Do not place your hand inside of the sample aliquot station.
NOTES
• Each loaded rack must have a rack ID that is set up for your system. A rack
loaded with an ID that was not set up will pass through the system without
being processed. For more information, see the Setting Up Rack IDs
procedure in Section 2.3: Supplies Setup of the Reference Manual.
• Be sure that the rack ID bar code label is in good condition and is properly
affixed to the rack. For more information, see Section 2.3: Supplies Setup in
the Reference Manual procedure.
• You can reuse a rack after it is aliquoted by the system. You cannot have two
racks with the same rack ID in the onload area of the SPU.
• Confirm that all tests requested for a STAT sample have an active assay
calibration listed on the Calibration screen. For more information, see the
• Do not load a rack while the utility routine is running.
System Mode: Ready Running
WARNING
In the following step, if your sample containers do not have bar code labels, be
sure to place the sample containers in the positions you specified on the Test
Requests screen. If the containers are not placed in the designated positions, the
system will report incorrect test results.
1. Place the sample containers for the requested tests in a rack. For more
information, see the Placing Sample Containers in Racks topic.

C73199-AA
2. Select the STAT button (see Figure 3-15).

If the system is aliquoting tests, it completes the current sample container and then
moves the current rack to the aliquot station. The system moves the rack pusher to the
home position and unlocks the SPU cover.
NOTES
• The system assigns the Requested status to interrupted LIS test requests, and
lists the requests on the Work Pending screen (see Figure 3-5 in Section 3.2:
LIS Requests and Work Pending). The tests are removed from the work
pending list when the system scans the rack again.
• The system assigns the Requested status to interrupted manual test requests,
and lists the requests on the Requested view of the Sample Manager screen.
3. Open the SPU cover.
4. Gently push any racks to the right, moving them from the sample aliquot station
to the onload area (see Figure 3-16).
NOTE
Do not remove the racks from the instrument unless it is necessary.
CAUTION
In the following steps, be sure the bar code label is on the right side of the
rack. If the rack is loaded incorrectly, it may jam on the SPU or pass through
without being aliquoted.
5. Place the rack containing the STAT sample ahead of the other racks in the onload
area. Be sure the bar code label is on the right side of the rack, and the rack arms
rest over the guide rails on either side of the onload area (see Figure 3-16).
6. If you interrupted sample processing to load the STAT rack, place the rack
containing the interrupted samples to the right of any STAT racks and to the left
of the routine racks in the onload area of the SPU.
7. Close the SPU cover.

The system pushes the STAT rack to the sample aliquot station.
NOTE
If the Console icon on the system status panel and the Amber system indicator
light begin to blink, there may be a rack remaining in the sample aliquot station.
Open the SPU cover, remove the rack, and close the cover again.

C73199-AA
Place the sample containers

for the requested tests in a
rack
Select the STAT button and

open the sample
presentation unit (SPU)
cover
Gently move the racks from

the sample aliquot station to
the onload area
Place the STAT rack in front

of all other racks in the
onload area
If sample processing was

interrupted, place the rack
containing the interrupted
samples in the onload area
Close the SPU cover
3001C.wmf
Figure 3-18 Loading a STAT Rack Flowchart
Unloading a After each sample in a rack is aliquoted, the system moves the rack to the offload area
Rack of the SPU. The offload area of the UniCel DxI 800 instrument holds up to 31 racks,
filling across the front of the instrument and then to the side. The offload area of the
UniCel DxI 600 instrument holds up to 15 racks. If the offload area becomes full, the
system records an event in the Event Log. The system continues to process tests, but
will not process any new test requests. You must unload racks to continue sample
processing.

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Use this procedure to unload a rack from the offload area.
WARNING

1. Check the front and side offload areas for racks.
5
1
2151A.eps
1 Side offload area (DxI 800 Only)

2 Side offload area cover (DxI 800 Only)
3 SPU cover
4 Sample aliquot station
5 Front offload area
Figure 3-19 Unloading Racks

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2. If there are racks present in one or both offload areas, open the appropriate
covers.
• SPU cover - Open this cover to unload racks from the front off load area. If the
onload pusher motion indicator (see Figure 3-15) is lit, the system is working
with a rack and the SPU cover is locked. You can unload racks when the system
unlocks the cover. If the SPU cover does not open, troubleshoot according to the
information displayed in the Event Log. For more information, see Section 5.4:
Event-Specific Troubleshooting in the Reference Manual.
• Side offload area cover - Open this cover to unload racks from the side offload
area cover. You can unload racks from this area at any time.
3. Unload all racks from the front and side offload areas.
4. Close the open covers.

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UniCel DxI Operator's Guide 3.5: Monitoring Sample Progress
3.5 Monitoring Sample Progress
During sample processing, the UniCel DxI system provides the following status
information.
• Individual sample status, or the status of all samples in a rack
• Test status
The system displays rack and sample status information in the Status column of two
Sample Manager screen views:
• In Progress view
• Daily view
The system displays the test status in the Results column of the Test Results screen.
For more information, see Section 4.1: Test Results Overview.

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3.5: Monitoring Sample Progress UniCel DxI Operator's Guide
Sample You can monitor the status of individual samples in the Status column on the In
Status Progress or Daily views of the Sample Manager screen. For more information, see the
Sample Manager Screen topic in Section 3.1: Sample Manager Overview.
Sample Status Definition
No Tests There is no test request for the sample.

Requested There is a test request for the sample.
Aspirated The system removed a sample aliquot for processing.
Supply Wait The system requires supplies, a calibration, or an enabled
pipettor before it can process the test requests.
In Progress The system is processing the requested tests.
*Done* The system completed processing the tests, but at least
one test was cancelled.
Done The system completed processing the tests and displayed
a result.
Table 3-20 Sample Status Descriptions
Test Status You can monitor individual test status until a result is generated by looking at the
Result column on the Test Results screen. For more information about this screen, see
Section 4.3: Reviewing Test Results.
Test Status Description
Requested There is a test request for the sample.

Supply Wait The test requires supplies, a calibration, or an enabled
pipettor before it can be run.
In Progress The test is in one of the following states:
• Waiting to be scheduled
• Scheduled for processing
• Aliquoted, but not yet processed
• Calculating a test result
Cancelled The test was cancelled before a result was calculated.
Table 3-21 Test Status Descriptions

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UniCel DxI Operator's Guide 3.6: Editing Test Requests
3.6 Editing Test Requests
While a manually entered rack is in the onload area of the sample presentation unit
(SPU), you can access and edit the test request information on the Test Requests
screen. From the Test Requests screen, you can modify manually entered test requests
in the following ways:
• Cancel a request
• Edit the sample information fields
• Add and remove tests
• Delete a selected sample or a rack of samples
When a rack is in the sample aliquot station, you can no longer edit the test requests.
NOTE
Do not edit test requests downloaded from a laboratory information system (LIS)
on the Test Requests screen. Edit these test requests at the LIS instead.
Cancelling the Use this procedure to cancel the test requests in a manually entered rack that has not
Test Requests been scanned.
on a Rack System Mode: Any Mode
1. From the Requested view of the Sample Manager screen, select the rack that
contains the test requests that you will cancel.
 (Optional) From the Daily view, select an individual sample from the rack that
contains the test requests that you will cancel.
2. Select Edit Request F2 to display the rack on the Test Requests screen.
3. Select Cancel Request F6.
4. Select Yes F1 to cancel the entire rack of test requests and return to the Sample
Manager screen.

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3.6: Editing Test Requests UniCel DxI Operator's Guide
Editing a Use this procedure to edit a manual test request for a patient sample in a rack that has
Manual Test not been scanned.
Request System Mode: Any Mode
contains the test requests that you intend to edit.
contains the test requests that you intend to edit.
3. Select the sample position that you intend to edit.
4. Edit any of the information in the following fields:
• Rack ID • Sample Type

• Sample ID • STAT
• Patient ID or Lot Number • Comment
• Dilution
For more information about these fields, see the Test Requests Screen for Patient/QC
Samples topic in Section 3.3: Patient Test Requests.
NOTE
If you edit the sample ID, the system deletes all of the sample information and the
requested tests.
5. Edit the test list using the Test buttons. The system adds or deletes tests in
increments of one.
• To add a test, select a Test button.
• To delete a test, select the test in the Tests Requested for Sample X list and then
select Remove.
 (Optional) To edit additional test requests on the same rack, repeat steps 3-5.
6. Exit the Test Requests screen to save your changes.

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Sample Manager
From the Requested view,
select the rack that contains
the test request that you
intend to edit
Edit Request F2
Test Requests
Select the sample position

that you intend to edit
Edit the sample information

and the test list
No
Done editing the
rack?
Yes
Test Requests
Exit the Test Request screen

to save changes
2097C.svg
Figure 3-22 Editing a Manual Test Request Flowchart

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Deleting a When you delete a manually entered sample from the Test Requests screen, all of the
Sample from sample information for the container is deleted from the screen. You can delete a
the Test sample until the system scans its sample container.
Requests Use this procedure to delete a manually entered sample from the Test Requests
Screen screen.

contains the test requests that you intend to delete.
contains the test requests that you intend to delete.
3. Select the sample position that you intend to delete.

• To delete one sample from the rack, select the sample position and then select
Delete Sample F2. Repeat to delete another sample on the same rack.
• To delete all of the samples in the rack, select Clear All Samples F7.

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Sample Manager
From the Requested view,

select the rack that contains
the sample that you
intend to delete
Edit Request F2
Test Requests
Deleting all
No Select the sample that you
samples in the
intend to delete
rack?
Yes
Clear All Samples F7 Delete Sample F2
Test Requests
Yes Done deleting No

Exit the Test Request screen samples?
to save changes
2098C.svg
Figure 3-23 Deleting a Sample from the Test Requests Screen Flowchart

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Changing a Use this procedure to change a rack ID for a manually entered rack.
Rack ID
NOTE
You cannot use a rack ID that is assigned to another rack in the onload area of the
SPU.

1. From the Sample Manager screen, select the Requested button to display the
Requested view.
2. Select the rack with the ID that you intend to change.
3. Select Edit Request F2 to display the Test Requests screen.
4. Select Rack ID F1.

The Enter ID field on the Rack button is now ready for entry.
NOTE
If you are changing the rack ID for a calibration that requires more than four
containers, both Rack buttons display on the screen. Select Rack ID F1, and then
select First F1 to change the first rack ID, or select Second F2 to change the
second rack ID.
5. Enter the new rack ID and press [Enter].

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UniCel DxI Operator's Guide 3.7: Patient Sample Troubleshooting
3.7 Patient Sample Troubleshooting
Unexpected or abnormal patient sample results can occur for various reasons. To rule
out and fix the most significant problems first, troubleshoot each failure in the
following order:
1. Identify event log errors. Contact Technical Support if you need help
troubleshooting event log errors. For more information, see Chapter 5: Event Log
in the Reference Manual.
2. Troubleshoot test result flags. For more information, see Section 4.3: Reviewing
Test Results.
3. Check the quality control (QC) results. If the results failed, troubleshoot
according to the instructions documented in Section 6.7: QC Troubleshooting
Overview.
4. Troubleshoot according to patient sample troubleshooting tables.
If you are unable to identify the cause of your problem, or if the problem persists after
performing the specified troubleshooting procedures, contact Technical Support for
assistance.

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3.7: Patient Sample Troubleshooting UniCel DxI Operator's Guide
Troubleshooting Use the following table to troubleshoot patient sample results that do not seem
Unexpected correct.
Patient Sample
Results
Possible Causes Corrective Action
Incorrect patient sample type Refer to the reagent instructions for use for the
appropriate sample types for each assay.
Incorrect sample dilution 1. If the sample result was generated with an

automated dilution (for example, the Diluted
ßhCG assay), repeat the sample in the standard
assay format (Total ßhCG assay).
2. If the results are still too low, contact Technical
Support.
Patient sample handled incorrectly Be sure that sample is stored and handled according to
proper laboratory procedures. Refer to individual
assay reagent instructions for use for proper sample
handling instructions.
Microclots present in the serum 1. Spin the sample again or use a serum filter to
sample separate the serum from any microclots.
2. Repeat the test.
Quantity of patient sample not 1. Calculate the correct volume of patient sample
sufficient for testing (QNS result flag needed for the number of replicates and type of
and event) sample container used (see Section A.2).
2. Pipette the amount of patient sample calculated in
step 1 into the appropriate sample container.
3. Be sure the rack and rack ID are correct (see
Section 2.3 in the Reference Manual).
4. Repeat the test.
5. If the test fails again, contact Technical Support
for assistance.
Expired reagent pack 1. Check the reagent pack expiration date on the
Reagent Inventory screen (see Section 2.8).
2. Unload the expired reagent pack and load a new
one (see Section 2.7).
• If the lot number of the new reagent pack is
different than the expired pack, recalibrate the
assay.
3. Repeat the test.
Reagent pack unstable or 1. Unload the reagent pack and load a new reagent
contaminated due to improper pack (see Section 2.7).
handling • If the lot number of the new reagent pack is
different than the removed pack, you must
recalibrate the assay.
2. Repeat the test.
Table 3-24 Troubleshooting Unexpected Patient Sample Results

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UniCel DxI Operator's Guide 3.7: Patient Sample Troubleshooting
Expired assay calibration 1. Check the Reagent Pack button on the Reagent
Supplies screen (see Section 2.7). If the Lot
Number field is red, the calibration has expired.
2. View the test results (see Section 4.3). Any test
results calculated with an expired calibration will
be flagged.
3. Recalibrate the assay.
4. Repeat the test.
Quality controls (QC) not run after 1. Run QC.

preventive maintenance or repair 2. Evaluate any out-of-range QC results according to
your established laboratory procedures.
3. Troubleshoot any test result flags, and recalibrate
the assay if necessary.
4. Repeat the test.
Partial bottles of substrate combined 1. Change the in-use substrate bottle and prime the
substrate (see Section 2.2).
2. Repeat the test
Routine maintenance not performed 1. Perform maintenance (see Section 7.1).

2. Repeat the test.
Wrong sample container and/or rack Load the samples using appropriate sample containers
and racks. Be sure that the sample containers are in a
rack with the correct rack ID (see Section 2.3:
Supplies Setup in the Reference Manual).
Sample container missing or placed in 1. Be sure that the sample containers are in the
incorrect position in the rack proper order in the rack.
2. Repeat the test.
Contaminated substrate supply 1. Contact Technical Support to verify the need to

decontaminate the substrate.
2. Decontaminate the substrate (see Section 6.4 of
the Reference Manual).
Table 3-24 Troubleshooting Unexpected Patient Sample Results

(continued)

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3.7: Patient Sample Troubleshooting UniCel DxI Operator's Guide
Troubleshooting Use the following table to troubleshoot patient sample results that demonstrate poor
Patient Sample precision, value shifts, or values that increase over the course of a run.
Results with
Increased
Variability
Expired reagent pack 1. Check the reagent pack expiration date on the
Reagent Inventory screen (see Section 2.8).
2. Unload the expired reagent pack and load a new
one (see Section 2.7).
• If the lot number of the new reagent pack is
different than the expired pack, recalibrate the
assay.
3. Repeat the test.
Expired assay calibration 1. Check the Reagent Pack button on the Reagent
Supplies screen (see Section 2.7). If the Lot
Number field is red, the calibration has expired.
2. View the test results (see Section 4.3). Any test
results calculated with an expired calibration will
be flagged.
3. Recalibrate the assay.
4. Repeat the test.
Quality controls (QC) not run after 1. Run QC.

preventive maintenance or repair 2. Evaluate any out-of-range QC results according to
your established laboratory procedures.
3. Troubleshoot any test result flags, and recalibrate
the assay if necessary.
4. Repeat the test.
Routine maintenance not performed 1. Perform maintenance (see Section 7.1).

2. Repeat the test.
Wash buffer contaminated Contact Technical Support.
Table 3-25 Troubleshooting Patient Sample Results with Increased

Variability

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UniCel DxI Operator's Guide 4: Test Results
4 Test Results
4.1 Test Results Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Test Results Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Refreshing the Test Results Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Configuring the Test Results Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-10
Selecting Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11
4.2 Test Result Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Applying a Test Result Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13
Defining or Editing a Test Result Filter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
Deleting a Test Result Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20
4.3 Reviewing Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-21
Finding a Test Result . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-22
Viewing Sample Details. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25
Test Result Flags and Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-27
Rerunning a Patient Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-38
4.4 Managing Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-39
Copying Test Results to a Disk or Flash Drive . . . . . . . . . . . . . . . . . . . . . . . 4-40
Sending Test Results to the LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-45
Deleting a Test Result . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-48

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4: Test Results UniCel DxI Operator's Guide
4.5 Test Result Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-50
Test Result Report Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-51
Printing Test Result Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-57
Printing the Continuous Sample Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-60

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UniCel DxI Operator's Guide 4.1: Test Results Overview
4.1 Test Results Overview
Test results are data that the UniCel DxI system creates and stores for every test the
system runs. To view test results, display the Test Results screen. To view a specific
result or a set of specific results, apply a test result filter to the screen or use the find
feature to limit or change the results displayed on the screen.
For each test result, you can view sample details such as patient demographics,
sample comments, and flag descriptions. For results with flags, you can view
troubleshooting information. For more information, see the Viewing Sample Details
procedure or the Test Result Flags and Troubleshooting procedure in Section 4.3:
Reviewing Test Results.
Upon reviewing a patient or quality control result, you might decide to rerun the test
from the Test Result screen. After reviewing any result, you can manually delete the
result from the system database. However, most results are deleted using the
Auto-Delete function. For more information, see the Setting Up the Auto-Delete
Feature procedure in Section 2.6: Data Management of the Reference Manual.
Test results can be saved for your laboratory archives in several ways:
• Send results to the LIS
• Copy results to a disk and import them into a PC-based spreadsheet program
• Print results in one of several report formats

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4.1: Test Results Overview UniCel DxI Operator's Guide
View results
(Optional)
Configure screen (to present
results according to your lab
needs)
(Optional)
Define filter (to present
results according to your lab
needs)
(Optional)
Is the result No
Archive, delete, or print
flagged?
results
Yes
View details and

troubleshoot
(Optional)
Archive, delete, or print
results
2080B.wmf
Figure 4-1 Test Results Overview Flowchart
Test Results Use the Test Results screen to:

Screen • View or print test results
• Troubleshoot test results with flags
• Rerun a test
• Manage results manually

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2036B.bmp
Filter (Field) Displays the selected filter and sort order. Each time you change the filter, it
becomes the default filter.
NOTE
If you display the Test Results screen from the Test Requests screen or from the
Daily View or Exceptions View of the Sample Manager screen, the Daily View
filter is the default filter.
Entries (Field) Displays the number of test results that meet the selected filter parameters.
Displays a visual cue (+) when more results are available since the filter was applied.
To see the results, refresh the screen.
For more information, see the Refreshing the Test Results Screen procedure.
Selected Result (Row) Displays an Arrow button at the beginning of the selected row. The selected
row is highlighted. If more than one row is selected, all rows are highlighted and the
Arrow button is displayed in the last row selected. For more information, see the
Selecting Test Results procedure.
Figure 4-2 Test Result Screen Descriptions

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Patient ID (Optional column) Displays the patient ID, if one exists, for the patient sample.
Sample ID (Required column) Displays the sample ID that is associated with the result.
Rack (Optional column) Displays the number of the rack that the sample is in.
Test Name (Required column) Displays the test name that is associated with the result.
Result (Required column) Displays the result of the test, including the value, units, and
interpretation (if applicable).
• Results described below are displayed with bold, red type.
- Patients:
• Results associated with any of the following flags: ORL, ORH, CRL, CRH, GRY,
OVR
• Results preceded by < (Results below the assay’s lowest reportable result)
• Qualitative, confirmatory, or semi-quantitative results interpreted as Positive,
Equivocal, Reactive, Confirmed, or Class 1, 2, 3, 4, 5, or 6
- Controls:
• Results associated with an OVR or QCF flag
• Results preceded by < (Results below the assay’s lowest reportable result)
- Calibrators: All Reactive calibrators
• If a test result is below the lowest reportable result, the result is displayed as <x,
where x is the lowest reportable result. Semi-quantitative, onboard dilution results
below the lowest reportable result are reported as, No Interpretation <x.
• For onboard dilution test results, the lowest reportable result is defined in the APF,
and is typically 85% of the undiluted parent assay’s highest calibrator
concentration. In cases where the test result is below the lowest reportable result,
run the undiluted parent test instead. For more information, see Onboard Dilutions
in Section 1.3: Sample Processing Theory of the Reference Manual.
• If test processing is incomplete, the test status is displayed. For more information,
see the Test Status topic in Section 3.5: Monitoring Sample Progress.
Pipettor (Optional column) Displays the reagent pipettor on which the test was run.
Flags (Required column) Displays the flags associated with the result. If there are no flags,
the field is blank.
Figure 4-2 Test Result Screen Descriptions (continued)

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LIS (Optional column) Displays the LIS status of the test result. Values are:
• <blank> - The result has not yet been calculated, or the result has just been
calculated, but the system has not updated the LIS status yet. Alternatively, the
result is not intended for the LIS (a calibrator or maintenance result).
• Sending - The system is sending the result to the LIS.
• Accepted - The system sent the result and the LIS received it.
• Not Sent - The system did not send the result to the LIS because the result did not
meet the Auto-Verify criteria. Alternatively, the system did not send the result to
the LIS because one or more of the following settings in the LIS Setup window
have been made:
- The Local LIS Interface field is set to Off.
- The Global LIS Interface field is set to Off.
- The Auto Send to LIS field is set to Off.
• Failed - The system sent the result, but the LIS did not receive it. Resend the result.
For more information, see the Sending Test Results to the LIS procedure in Section
4.4: Managing Test Results.
• Idle - The system attempted to send the result to the LIS while the global LIS
interface was offline. Set the global LIS interface to On to automatically send
results with this status to the LIS. For more information, see the Setting Up the LIS
Interface procedure in Section 2.5: LIS Setup of the Reference Manual.
Rgt. Lot (Optional column - not shown) For systems running with software version 5.2 or
higher, this column displays the reagent pack lot number that was used for generating
the test result.
Pack S/N (Optional column - not shown) For systems running with software version 5.2 or
higher, this column displays the serial number of the reagent pack lot that was used for
generating the test result.
RLU (Optional column - not shown) Displays the RLUs for the test result.
Comp. Time (Optional column - not shown) Displays the date and completion time of the test.

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Verify (Optional column - not shown) Displays the status of the test results. When the LIS is
set up to send only auto-verified results to the LIS, the system compares the test
results to the LIS ranges you defined. For more information, see Section 2.5: LIS
Setup. Also see Section 3.4: Ranges Setup in the Reference Manual. Values are:
• <blank> - The system has not compared the test result to the set LIS ranges. If the
column is blank, it usually means the result has not been calculated yet.
• Pass - The test result was within the set LIS ranges.
• Fail - The test result was not within the set LIS ranges and the system cannot send it
to the LIS. The system displays the word Fail in red.
• Not Verified - The LIS is not set up to verify results.
Instrument (Optional column - not shown) Displays the ID of the instrument on which the test
was run.
Filter (Button) Select to apply, edit, or delete test result filters. The system displays the
F1 selected filter and sort order in the Filter field. For more information, see
Section 4.2: Test Result Filters.
Find (Button) Select to search the filtered results for a specific test result. For more
F2 information, see the Finding a Test Result procedure in Section 4.3: Reviewing Test
Results.
Rerun Test (Button) Select to run the selected test again. If sufficient sample to rerun the test
F3 remains on the instrument, the test is automatically assigned and runs at the next
opportunity. For more information, see the Rerunning a Patient Test procedure in
Section 4.3: Reviewing Test Results, or see the Rerunning a QC Test procedure in
Section 6.7: QC Troubleshooting Overview. If there is not enough sample on the
instrument to rerun the test, the system displays the test request on the Work Pending
screen. For more information, see Section 3.2: LIS Requests and Work Pending.
Sample Details (Button) Select to display sample related patient demographic information, comments
F4 entered by the operator, test result flags, and flag definitions. For results with flags,
troubleshooting information can be accessed from the Sample Details window. For
more information, see the Viewing Sample Details procedure in Section 4.3:
Reviewing Test Results.
Send to LIS (Button) Select to send test results to the LIS. For more information, see the Sending
F5 Test Results to the LIS procedure in Section 4.4: Managing Test Results.
Copy to Disk (Button) Select to copy all test results or the selected test results to a disk. For more
F6 information, see the Copying Test Results to a Disk or Flash Drive procedure
in Section 4.4: Managing Test Results.

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Print (Button) Select to display a menu of the following report options:

F7 Report F1
Select to print the Patient Report, Sample Report, or the Selected Test Result Report
for all tests that match the filter parameters.
Completed Samples F2
Select to manually print the Continuous Sample Report for tests that are completed,
but not yet printed.
For more information, see Section 4.5: Test Result Reports.
More Options (Button) Select to display a menu of the following options:
F8 Refresh Screen F1
Select to update the information displayed on the Test Result screen and display new
results that match the filter parameters. For more information, see the Refreshing the
Test Results Screen procedure.
Configure Screen F2
Select to change the column order or the columns displayed on the Test Result screen.
For more information, see the Configuring the Test Results Screen procedure.
Delete Data F3
Select to remove test result data from the system database. For more information, see
the Deleting a Test Result procedure in Section 4.4: Managing Test Results.
NOTE
You need the system password to use this feature.
Refreshing When a plus sign (+) is displayed in the Entries field of the Test Results screen,
the Test refresh the screen.
Results System Mode: Any Mode
Screen 1. From the Test Results screen, select More Options F8.
2. Select Refresh Screen F1.

The current filter is applied again and new results that match the filter parameters are
added to the Test Results screen.

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Configuring Use this procedure to add or rearrange result information on the Test Result screen.
the Test The Sample ID, Test Name, Result, and Flags columns are required, but you can
Results change their order on the screen.
Screen The Patient ID column is displayed by default for most filters. However, for the
Failed Auto-Verify and Not Sent to LIS filter, the system displays the Verify column
and does not display the Patient ID column.
1. From the Test Results screen, select More Options F8, then Configure
Screen F2.
The Configure Screen window displays the columns in the order they display on the
Test Results screen.
Column Order
Buttons
0602A.bmp
Column Order (Row) Displays the columns currently displayed on the Test Results screen, in their
respective order.
Optional Columns (Boxes) Select the optional columns to include on the Test Results screen.
Column Order (Buttons) Select the right or left Arrow button to rearrange a selected column in the
Buttons Column Order row. If you do not select a column before selecting an Arrow button,
the first column is selected by default.
Figure 4-3 Configure (Test Results) Screen Window Descriptions

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2. In the Optional Columns list, select the columns you want to add to the Test
Result screen from the following options: Patient ID, Rack, Verify, Comp. Time,
LIS, Instrument, RLU, and Pipettor. For systems running with software
version 5.2 or higher, you can also select the Rgt. Lot and Pack S/N options.
You can add optional columns until you reach the maximum width of the screen.
 (Optional) To rearrange the order of the columns, select a column in the Column
Order row and use the right or left column order button to move it.
3. Select OK F1.
The Test Result screen displays the columns in the order you selected.
Selecting Test Select individual results to limit the data that prints on a report, to rerun a specific test,
Results to limit the data that is copied to a disk or to an LIS, to limit the data that is deleted, or
to investigate information associated with specific results.
Follow the guidelines below to select one or more test results on the Test Result
screen.
1. From the Test Results screen, locate a single test result or a group of test results.
To locate a single test result, see the Finding a Test Result procedure in Section 4.3:
Reviewing Test Results. To locate a group of test results, see the Applying a Test
Result Filter procedure in Section 4.2: Test Result Filters.
NOTES
• To view the results that are out of the current viewing area, use the scroll bar.
• To go to the beginning or end of the test result list, press the [Ctrl] key while
you press the [Home] or [End] key, respectively.
2. Select the result or the group of results by taking one of the following actions.
• To select one result:
Select a row by touching it. By default, one result is selected on the Test Result
screen, as indicated by the Arrow button to the left of the row. When you select a new
result, the Arrow button is displayed to the left of the new row you selected and is
cleared from the previous selection.
• To select multiple contiguous results:
Select the first result, press and hold the [Shift] key, and then select the last of the
contiguous results.

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Example
To select the first 5 results, select the first result, press and hold the [Shift] key,
and then select the fifth result. Release the [Shift] key. All five results are
selected.
• To select multiple non-contiguous results:

Select the first result, press and hold the [Ctrl] key, and then select the other results.
Example
To select the first, second, and fourth results shown on the Test Results screen,
select the first result, then press the [Ctrl] key and select the other results. Release
the [Ctrl] key. Each of the rows is selected.
NOTES
• If you select a group of results and then select Rerun Test F3 or
Sample Details F4, only the result indicated with the Arrow button is rerun
or displayed in the Details window.
• If you select a group of results and then select Send to LIS F5 or Copy to
Disk F6, you must select Current Selection in the window to send or copy
all selected results. Otherwise, only the result with the Arrow button is sent or
copied.
 (Optional) To remove a selection from a group of selected results, press the [Ctrl]
key while you select the result you want cleared.

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UniCel DxI Operator's Guide 4.2: Test Result Filters
4.2 Test Result Filters
You can create and edit test result filters for the Test Results screen, or apply
system-defined filters.
To create new filters, you can define all of the parameters for the filter, or you can edit
an existing filter. If you edit a system-defined filter, and you want to save the changes,
you must save the new filter with a different name. To view a list of the
system-defined filters with their default sort orders, see the Applying a Test Result
Filter procedure.
For more information, see the Filters and Sort Order topic in Section 1.3: Software
Overview.
Applying a Use this procedure to apply one of the available test result filters.
Test Result
The following test result filters are system defined:
Filter
Filter 1st Sort 2nd Sort
All Flagged Test Results (Last 30 days) Sample ID Test Name

All Patient Samples (Last 30 days) Sample ID Test Name
All Patient Samples Loaded Between... Completion Time
All Samples (Last 30 days) Sample ID Test Name
All Samples Loaded Between... Completion Time
Failed Auto-Verify and Not Sent to LIS Sample ID Test Name
LIS Transmission Failed Sample ID Test Name
On-board Patient Samples Sample ID Test Name
On-board Samples Sample ID Test Name
On-board STAT Samples Sample ID Test Name
Table 4-4 Test Result Filters and Default Sort Orders

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4.2: Test Result Filters UniCel DxI Operator's Guide

1. From the Test Results screen, select Filter F1.
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Filter (List) Displays a list of available system-defined and laboratory-defined filters.

1st Sort Order (Option) Select to change the primary sort order. The default sort order depends on
the filter (see Table 4-4).
2nd Sort Order (Option) Select to change the secondary sort order. The default sort order depends
on the filter (see Table 4-4).
Ascending (Box) Select to sort the results in ascending numeric or alphabetic order and clear
to sort by descending numeric or alphabetic order.
Examples
• A filter applied to results according to Rack ID in ascending order displays
results from rack 1 at the top of the screen, followed by results from rack 2
and other racks in ascending order.
• A filter applied to results according to Test Name in ascending order
displays Ferritin results closer to the top of the screen than TPOAb results.
Description (Field) Displays a description of the selected filter.
New Filter (Button) Select to define a new filter.
F2
Figure 4-5 Filter (Test Results) Window Descriptions

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Edit Filter (Button) Select to edit the parameters of the selected filter. You can then save the
F3 changes as a new filter or apply the edited filter without saving it.
Delete Filter (Button) Select to delete the laboratory-defined filter selected in the Filter list.
F4
NOTE
You cannot delete a system-defined filter.
Figure 4-5 Filter (Test Results) Window Descriptions (continued)
2. Select a filter from the list.

The system displays a description of the filter in the Description field.
 (Optional) To change the sort order, select an option from each of the sort order
lists.
 (Optional) To display the results in descending order, clear the Ascending box.
3. Select OK F1.
The system displays all test results that meet the selected filter parameters on the Test
Results screen. The applied filter becomes the default filter until you apply a different
saved filter.
NOTE
If you select the system-defined filters All Patient Samples Loaded Between...
or All Samples Loaded Between..., or a laboratory-defined filter that asks for
the date and time, the system prompts you to enter the date range.
Defining or Use this procedure to define a new filter or edit an existing filter and apply it to the
Editing a Test Test Results screen.
Result Filter
NOTE
The New Filter and Edit Filter windows are the same, but the New Filter fields
default to all and New Filter check boxes are selected, except for the Ask for
Date & Time box.

1. From the Test Results screen, select Filter F1 to display the Filter window (see
Figure 4-5).
 (Optional) Select different Sort Order options.

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2. Perform one of the following actions:

• To create a new filter, select New Filter F2.
• To edit an existing filter, select the filter you want to edit from the Filter list
and select Edit Filter F3.
NOTE
Every new filter has the default sort orders Sample ID and Test Name.
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Filter Name (Field) Displays the name of the filter selected in the Filter window. You can delete
the name and enter a new name to create a new filter.
Description (Field) Displays the description of the filter selected in the Filter window. You can
delete the description and enter a new description.
Ask for Date & (Box) Select to have the system ask for date and time parameters each time you
Time apply the filter.
Instruments (Box) Displays your instrument box selected by default. Includes your instrument
in the filter when the box is selected.
Test Result Status (Boxes) Select one or more of the test result statuses to include in the filter.
LIS State (List) Select the LIS state to include in your filter.
Figure 4-6 Edit Filter (Test Results) Window Descriptions

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Sample ID (List) Select a relationship operator from the list.

(Field) For list values other than (all), enter the sample ID that completes the
relational statement for the samples to include in the filter.
Example
If you select > from the list, and enter 1011 in the field, then the filter includes
results with sample IDs > 1011.
Test Name (List) Select the enabled tests to include in the filter. The list contains all enabled
test names.
Auto-Verify (List) Select the status of the test results to include in the filter.
Values are: unverified, pass, fail, or all results.
Rack ID (List) Select the rack IDs to include in the filter. The list contains all racks shown
in the Requested View of the Sample Manager screen.
Patient ID (List) Select a relationship operator from the list.
(Field) For list values other than (all), enter the patient ID that completes the
relational statement for the samples to include in the filter.
Example
If you select = from the list, and enter 12345678 in the field, then the filter
includes results for patient ID 12345678.
Result (List) Select a relationship operator from the list.
(Fields) For values other than (all), enter a numeric value that completes the
relational statement for the results to include in the filter in the first field. For the
outside and between list values, enter a numeric value in the second field.
Example
If you set the value in the first box to >, and the value in the next box is 4.00,
then the filter includes results > 4.00.
NOTE
Because numerical results are rounded and truncated for display, the =
relationship operator is not often useful in a result filter. The result
1.000020 ng/ml is displayed as 1.00 ng/ml, but is not included by using the
filter = 1.00.
Population (Boxes) Select one or more of the result populations to include in the filter.
OK (Button) Select to save the edited filter with the same name and overwrite the
F1 previous filter. This is only allowed with laboratory-defined filters.
Figure 4-6 Edit Filter (Test Results) Window Descriptions (continued)

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Save As (Button) Select to save the edited filter as a new filter with a new name. For
F2 laboratory-defined filters, you can keep the same name and overwrite the previous
filter. When you save the filter, it is applied.
Clear Parameters (Button) Select to clear all of the fields and reset the parameters to the current filter
F3 parameters.
Figure 4-6 Edit Filter (Test Results) Window Descriptions (continued)
3. Locate and change the parameters you need to enter or edit. For descriptions of
the window parameters, see Figure 4-6.
4. Select OK F1.
The system prompts you to save the filter.
5. Select one of the following options:

• Select Yes F1 to display the Save As window.
If you entered a new name in the Filter Name field in step 3, it is displayed in the
Save Filter As... field. If not, enter a name for the filter in the Save Filter As... field.
Select OK F1.
• Select No F4 to apply the filter without saving the changes. The unnamed
filter remains the default filter until you apply a different one.
NOTE
If you select Cancel F8, your changes are not saved and the filter is not applied.
6. If you selected the Ask for Date & Time box in the Edit Filter window, the
Specify a Date Range window is displayed.
Enter the appropriate information. The date format follows the format you set up on
the System Setup screen. The system displays a message if the incorrect format is
used. For more information, see the Setting the Date and Time Formats procedure in
Section 2.2: System Setup of the Reference Manual.
7. Select OK F1.
The system displays the test results that meet the filter parameters on the Test Results
screen.

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Test Results
Filter F1
Filter
To edit, select the filter and

sort orders
New Filter F2 Edit Filter F3
Filter/Edit Filter
Edit the filter parameters
OK F1
Yes
Save the filter? Yes F1
No Specify the date and time (if

required), then give the filter
a name
No F4
OK F1
Specify the date and time (if
required), the system
applies the filter,
but does not save it
The system saves and
applies the filter
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Figure 4-7 Defining or Editing a Test Result Filter Flowchart

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Deleting a Use this procedure to delete laboratory-defined filters. You cannot delete
Test Result system-defined filters.
Filter System Mode: Any Mode
1. From the Test Results screen, select Filter F1 to display the Filter window.
2. In the Filter list, select the filter you want to delete.
3. Select Delete Filter F4. This button is not available for system-defined filters.
The system displays a confirmation message.
4. Select OK F1 to delete the filter.

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UniCel DxI Operator's Guide 4.3: Reviewing Test Results
4.3 Reviewing Test Results
The Test Results screen provides a wide variety of information about test results. To
examine the available information about test results, first locate the results. If you
cannot immediately locate a result, use one or more of the following features:
• Filter
• Find
• Refresh Screen
Generally, more information is available about results than can fit on the Test Result
screen at one time. The screen can be configured to display the information you
consider most important. For more information, see the Configuring the Test Results
Screen topic in Section 4.1: Test Results Overview.
Flags are codes that the UniCel DxI system associates with test results when a special
circumstance requires attention. Flags, flag explanations, and sample details can be
viewed from the Sample Details window.
When reviewing results for a particular sample, you can rerun any test previously run
on that sample.
NOTE
Manually requested patient test results are evaluated against default ranges, even
if your laboratory has established reference, critical, or LIS ranges. For more

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4.3: Reviewing Test Results UniCel DxI Operator's Guide
Finding a Test Use this procedure to find a specific test result on the Test Result screen.
Result
NOTE
This procedure finds only test results that fit the current filter parameters. If you
have difficulty finding a specific test result, apply a different filter.

1. From the Test Results screen, select Find F2.
2. In the Find window, enter information in one of the Sample ID, Patient ID, Rack
ID, or Test Name fields for the result you want to find.
NOTE
For the Sample ID and Patient ID field, you do not need to enter complete
information. The Find feature locates results based on the first characters you
enter in the field.
 (Optional) To change the direction of the search, select the Up or Down option.
If you select Down, the system begins the search at the currently selected result and
continues down the Test Result screen. If you select Up, the system begins the search
at the currently selected result and continues up the Test Result screen.
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Sample ID (Field) Enter all or part of the sample ID to find a result using only its sample ID.
Example
If you are searching for sample ID 123456789, you can enter 1234. The system
finds the first sample ID starting with 1234.
Rack ID (List) Select from a list of rack IDs for which there are results to find a result using
only its rack ID.
Figure 4-8 Find (Test Result) Window Descriptions

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Patient ID (Field) Enter all or part of the patient ID to find a result using only its patient ID.
Example
If you are searching for patient ID 123456789, you can enter 1234. The system
finds the first patient ID starting with 1234.
Test Name (List) Select from a list of test names or enter a test name to find a result using only
its test name.
Direction (Option) Select Up or Down to change the direction of the search. If you select
Down, the system begins the search at the currently selected result and continues
down the Test Result screen. If you select Up, the system begins the search at the
currently selected result and continues up the Test Result screen.
When a search reaches the top or bottom of the Test Result screen, the search
continues from the opposite end.
Find Next (Button) Select to find the next result that matches the information in the field.
F1
Figure 4-8 Find (Test Result) Window Descriptions (continued)
3. Select Find Next F1. The closest match to the search parameters you entered
becomes the selected result.
NOTES
• If the system does not find a match, a message is displayed in the status line
of the Test Result screen.
• If any of the filtered results have been deleted, a message is displayed that
directs you to refresh the screen. For more information, see the Refreshing
the Test Results Screen procedure in Section 4.1: Test Results Overview.
Repeat step 3.
 (Optional) To find the next result that matches the information in the field, select
Find Next F1.
4. Select Cancel F8 to exit the Find window.

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Test Results
Find F2
Find
Enter one of the following:

Sample ID, Patient ID, Rack
ID, or Test Name
(Optional)
Select a search direction, up
or down
Find Next F1
Is the result No
found?
Yes
Cancel F8
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Figure 4-9 Finding a Test Result Flowchart

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Viewing Use this procedure to view explanations about result flags or details about the sample
Sample a result is associated with, including demographic information and comments.
Details System Mode: Any Mode
1. From the Test Results screen, locate and select a single test result.
For more information on locating a result, see the Finding a Test Result procedure, or
the Applying a Test Result Filter procedure in Section 4.2: Test Result Filters. For
more information on selecting a result, see the Selecting Test Results procedure in
Section 4.1: Test Results Overview.
NOTE
If you select a group of results and then select Sample Details F4, only the result
indicated with Arrow button is displayed in the Details window.
2. Select Sample Details F4.
2043B.bmp
Patient ID (Field) Displays the patient ID for the patient sample. The Patient ID can be
entered on the Test Request screen or sent from the LIS. The Patient ID is required
if it is sent from the LIS.
Figure 4-10 Sample Details Window Descriptions

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First Name (Field) Displays the first name of the patient. This information is sent from the LIS.
Last Name (Field) Displays the last name of the patient. This information is sent from the LIS.
Sex (Field) Displays the sex of the patient. This information is sent from the LIS.
Birth Date (Field) Displays the birth date of the patient. This information is sent from the LIS.
Doctor Name (Field) Displays the name of the patient's doctor. This information is sent from the
LIS.
Sample ID (Field) Displays the sample ID.
Sample Type (Field) Displays the type of fluid in the sample container.
Offboard Dilution (Field) Displays the dilution factor for sample dilutions prepared manually.
Onboard Dilution (Field) Displays the dilution factor for onboard dilution assays and special dilution
assays.
For more information, see Onboard Dilutions in Section 1.3: Sample Processing
Theory of the Reference Manual.
Test Name (Field) Displays the name of the test that was run on the patient sample.
Reference Range (Field) Displays the reference range used to evaluate the test. For more
Result (Field) Displays the results of the test run on the sample.
Sample Comment (Field) Displays any comments about the sample entered from the Test Request
screen.
Flags (List) Displays any flags associated with the result and a description of each flag.
Troubleshoot (Button) Displays troubleshooting Help about flags.
F2
NOTE
This button is not available for results without flags.
Figure 4-10 Sample Details Window Descriptions (continued)
 (Optional) To get troubleshooting information about a result flag, select

Troubleshoot F2. The system displays the Help with a list of result flags linked
to troubleshooting information. For more information, see the Test Result Flags
and Troubleshooting topic.
3. Select OK F1.

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Test Result The following tables provide troubleshooting information associated with test result
Flags and flags that are fatal (no calculated result) or non-fatal (calculated result, but a condition
Troubleshooting 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. For more information, see the Viewing Sample
Details procedure.
Fatal Flag Description Corrective Action
AEX The aliquoted sample cannot be used for 1. Review the Event Log for error events with a similar
one or more of the following reasons: date and time to this event (see Section 5.2 in the
• An error occurred when the aliquot Reference Manual). If events are found, troubleshoot
was dispensed into the vessel. according to available information or contact Technical
Support.
• The aliquot has been on board the
instrument for up to three hours and 2. Make sure that required supplies are on board before
has expired. running the test again.
• The last test taken from the aliquot 3. Check the test status in the Result column of the Test
was completed one hour ago. Result screen and take one of the following actions:
• For calibrator and maintenance samples with the test
status Cancelled: Request the test again and load a
fresh quantity of 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 because: 1. Take one of the following actions:
• One of the tests included in a • For results other than derived results, skip to step 2.
derived result formula (see • For derived results, review each test result used in the
Section 3.6: Derived Result Setup in derived result formula. If a result failed, troubleshoot
the Reference Manual) did not according to the flag for that result.
produce a result.
2. Review the Event Log for error events with a similar
• A confirmatory test result could not date and time to this event (see Section 5.2 in the
be calculated. Usually this occurs Reference Manual). If events are found, troubleshoot
because the samples for the according to available information or contact Technical
qualitative and confirmatory tests Support.
were not aspirated at the same time
3. Repeat the test.
(see Section 1.5: Confirmatory
Assay Theory in the Reference • For a derived result, repeat all tests included in the
Manual). derived result formula.
• Another error prevented the system • For a confirmatory result, repeat the confirmatory and
from calculating a result. qualitative tests.
Table 4-11 Fatal Flags

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CLT An obstruction was detected in the sample Check the test status in the Result column of the Test Result
tube before aliquoting or in the RV during screen.
processing. • For patient and QC samples with the test status
Requested:
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
(see Configuring the Automatic Rerun Feature in
Section 3.3) and take one of the follow 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
positive slope calibration curves, the criteria, dilute and rerun the sample:
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 low. • The sample RLU is low.
• For competitive assays, which use See the reagent instructions for use to determine the
negative slope calibration curves, the assay type and whether sample dilution is allowed.
result is at either: 2. Rule out a system problem by reviewing the Event Log
• The high end of the concentration for error events with a date and time shortly before this
curve and cannot be distinguished event. Troubleshoot accordingly.
from a system failure because the 3. If you have ruled out a system problem and the IND flag
RLU reading is too low, or event is the only issue, recalibrating the affected assay
• The low end of the concentration may resolve the problem.
curve and cannot be distinguished • Recalibrate the assay using a new reagent pack and a
from a system failure because the new set of calibrators.
RLU reading is too high. • Run QC.
• Repeat the test on the affected sample.
If IND flags persist, contact Technical Support.
Table 4-11 Fatal Flags (continued)

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NCR No calibration data existed for the reagent 1. Calibrate the assay (see Section 5.3).
lot when the patient or QC result was 2. Repeat the test.
processed.
QNS The sample volume is insufficient in the Check the test status in the Result column on the Test Result
sample container or in the RV during screen.
processing. • For patient and QC samples with the test status
If the flag is applied because of Requested:
insufficient volume in the RV, and 1. Identify event log errors. Contact Technical Support if
Automatic Rerun is enabled, the test will you need help troubleshooting event log errors (see
be reordered. Otherwise, additional tests Section 5.1 in the Reference Manual).
will not be scheduled for this sample.
2. Pipette sufficient sample volume into the sample
Tests already scheduled will be completed.
container (see Section A.2) and make sure the rack is
appropriate for the sample container (see Section A.1).
3. Load the sample. The test is run automatically.
• For samples with the test status Cancelled:
1. Identify event log errors. Contact Technical Support if
you need help troubleshooting event log errors (see
2. Determine if the Automatic Rerun feature is enabled
(see Configuring the Automatic Rerun Feature in
Section 3.3) and take one of the follow actions.
proceed to step 3.
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 (see Section A.2) and make sure the rack is
appropriate for the sample container (see Section A.1).
5. Load the sample.
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.

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QSB A substrate dispense failure occurred 1. Prime the substrate (see Section 4.3 in the Reference
during processing. Manual) for four cycles.
2. Determine if the Automatic Rerun feature is enabled (see
Configuring the Automatic Rerun Feature in Section 3.3)
and take one of the follow actions.
proceed to step 3.
4. Load the sample.
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.
QSD Insufficient sample volume or reagent 1. Review the Event Log. Contact Technical Support if you
volume was dispensed into an RV. need help troubleshooting event log errors (see
proceed to step 3.
4. Load the sample.
automatically.

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QSS An insufficient volume of sample or 1. Review the Event Log. Contact Technical Support if you
reagent was withdrawn for the test. need help troubleshooting event log errors (see
proceed to step 3.
4. Load the sample.
automatically.
RLU The relative light units (RLUs) are outside 1. Review the Event Log. Contact Technical Support if you
the acceptable luminometer measuring need help troubleshooting event log errors (see
range. Section 5.1 in the Reference Manual).
proceed to step 3.
4. Load the sample.
automatically.

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SYS A device error occurred during processing. 1. Review the Event Log. Contact Technical Support if you
need help troubleshooting event log errors (see
proceed to step 3.
4. Load the sample.
automatically.
TRI The temperature of the analytical module 1. Check the wash carousel temperature on the
was outside the acceptable limits when the Maintenance Review screen. If the temperature is
test was being incubated. outside the acceptable limits, periodically monitor the
wash carousel 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.
• 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 (see Configuring the Automatic Rerun
Feature in Section 3.3) and take one of the follow
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.
4. Load the sample.
automatically.
5. If the temperature does not normalize, or if the problem
persists, contact Technical Support.

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TRS The temperature of the substrate was 1. Check the substrate temperature on the Maintenance
outside the acceptable limits when the Review screen. If the temperature is outside the
substrate was dispensed. acceptable limits, 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.
period of time, you may need to wait up to one hour for
the temperature to normalize.
2. When the substrate temperature is within the acceptable
limits, determine if the Automatic Rerun feature is
enabled (see Configuring the Automatic Rerun Feature
in Section 3.3) and take one of the follow 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.
4. Load the sample.
automatically.
5. If the temperature does not normalize, or if the problem
persists, contact Technical Support.
TRW The temperature of the analytical module 1. Follow the corrective actions provided for the TRI flag.
was outside the acceptable limits when the
reaction vessel was in the wash carousel.
Non-Fatal Flag Description Corrective Action
CEX The calibration curve or cut-off value is 1. Recalibrate the assay (see Section 5.3).
expired. 2. Repeat the test.
Table 4-12 Non-Fatal Flags

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CLX The calibrator lot is expired. • For patient and QC tests: Review the Calibration
Note: For patient and QC tests, the Data screen to determine whether replicates of the
calibrator lot may have expired after a active calibration are associated with the CLX flag
successful calibration. (see Section 5.4). Then take one of the following
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.
CRH The patient test result is above the upper This is a valid test result. No corrective action is
limit of the critical range. necessary.
CRL The patient test result is below the lower This is a valid test result. No corrective action is
limit of the critical range. necessary.
DEX The open pack stability time has expired 1. Make sure sufficient unexpired diluent is available
for the diluent pack. The system measures (see Section 2.7).
open pack stability separately by well. 2. Repeat the test.
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 (see Section 2.1).
2. If necessary, change the substrate bottle (see
Section 2.2).
3. Repeat the test.
GRY For qualitative assays, the patient or QC This is a valid test result. No corrective action is
result is within the specified gray zone., necessary.
also known as the equivocal zone.
LEX The reagent or diluent pack lot is expired. 1. Unload all of the packs from the expired reagent
lot and load a pack from a new lot (see
Section 2.7).
2. Repeat the test.
LOW The patient or QC result is lower than the No corrective action is necessary.
minimum reportable result value defined
in the APF.
Table 4-12 Non-Fatal Flags (continued)

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LRH The patient result is above the upper limit 1. Review the result.
of the LIS range. 2. Take one of the following actions:
Notes: • Send the result to the LIS manually (see
• If the Auto-Send to LIS option is set to Section 4.4).
Verify, the system does not • Delete the result (see Section 4.4) and repeat the
automatically send results with this flag test.
to the LIS.
• This flag is for quantitative assays,
semi-quantitative assays, and derived
results only.
LRL The patient result is below the lower limit 1. Review the result.
of the LIS range. 2. Take one of the following actions:
Notes: • Send the result to the LIS manually (see
• If the Auto-Send to LIS option is set to Section 4.4).
Verify, the system does not • Delete the result (see Section 4.4) and repeat the
automatically send results with this flag test.
to the LIS.
• This flag is for quantitative assays,
semi-quantitative assays, and derived
results only.
ORH The patient result is above the upper limit No corrective action is necessary.
of the reference range.
ORL The patient result is below the lower limit No corrective action is necessary.
of the reference range.

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OVR The calculated concentration is above the 1. Review the Event Log for error events with a
highest or most concentrated calibrator. similar date and time to this event (see Section 5.2
This flag is only used for quantitative and in the Reference Manual).
semi-quantitative assays. • If events occurred, troubleshoot (see Section 5.3
in the Reference Manual).
2. Take one of the following actions:
• 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 (see Section 6.7).
• 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, contact Technical Support.
PEX The open pack stability time has expired 1. Unload the expired reagent pack and load a new
for the reagent pack. The system starts one (see Section 2.7).
measuring open pack stability when it first • If the lot number of the new reagent pack is
punctures the pack. different than the expired pack, recalibrate the
Note: For an LIS attached to a DxI assay.
instrument, the PEX flag is sent to the LIS 2. Repeat the test.
in place of the DEX flag.
QCF The quality control result violates one or 1. Display the QC Chart and Data screen to review
more QC rules. which criteria is not met.
2. Follow the QC troubleshooting instructions (see
Section 6.7).
QEX The quality control lot is expired. 1. Add a new, unexpired quality control lot (see
Section 6.2). 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 reflex No corrective action is necessary for this flag alone.
test.

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TRA The temperature of the sample wheel was 1. Check the sample wheel temperature on the
outside the acceptable limits when the Maintenance Review screen (see Section 7.1). If
sample aliquot was in the sample wheel. the temperature is outside the acceptable limits,
periodically monitor the sample wheel temperature
on 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.
period of time, you may need to wait up to one
hour for the temperature to normalize.
2. When the sample wheel temperature is within the
acceptable limits, repeat the test.
3. If the temperature does not normalize, or if the
TRR The temperature of the reagent storage 1. Check the reagent storage chamber temperature on
chamber was outside the acceptable limits the Maintenance Review screen (see Section 7.1).
when reagents were pipetted. If the temperature is outside the 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.
period of time, you may need to wait up to one
hour for the temperature to normalize.
2. When the reagent storage chamber temperature is
within the acceptable limits, repeat the test.
3. If the temperature does not normalize, or if the

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Rerunning a Use this procedure to rerun one patient test at a time.

Patient Test
The system can be configured to automatically rerun patient and control tests that are
cancelled due to system errors. For more information, see the Configuring the
Automatic Rerun Feature in Section 3.3: Patient Test Requests.
NOTE
If the test status is Requested, and the sample container is bar coded, the test has
already been added to the Work Pending list and the system will prevent you from
requesting it again. Load the bar coded sample again and the test will run
automatically.
To rerun a quality control test, see the Rerunning a QC Test procedure in Section 6.7:
QC Troubleshooting Overview.
1. From the Test Results screen, locate and select the result you want to rerun.
For more information on locating results, see the Finding a Test Result procedure or
the Applying a Test Result Filter procedure in Section 4.2: Test Result Filters.
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.

The system displays a warning message.
3. Select OK F1 to complete the request and exit the window.

• If sufficient sample to rerun the test remains on the instrument in reserve
volume, the system automatically assigns the test and runs it at the next
opportunity.
• If there is not enough patient sample volume on the instrument, the system
assigns the request to the Work Pending screen. Load the bar coded sample
again and the test will run automatically. For more information, see
Section 3.2: LIS Requests and Work Pending.

C73199-AA
UniCel DxI Operator's Guide 4.4: Managing Test Results
4.4 Managing Test Results
You can manage test results by using system features to:

• Copy test results to a disk or flash drive
• Send test results to the LIS
• Delete test results
To store results offline before they are deleted from the system, copy test results to a
disk. After copying results to a disk or flash drive, transfer them to a spreadsheet
program for viewing.
If you have an LIS, you can configure the system to automatically send test results
with their associated flags to the LIS when sample processing is complete. For
information on configuring the LIS, see Chapter 2: System Administration in the
Reference Manual. However, occasionally you must manually send results to the LIS.
For more information, see the Sending Test Results to the LIS procedure.
All results remain on the system until they are deleted. Automatic deletion is the
preferred method for deleting results. For information on configuring automatic
deletion, see the Setting Up the Auto-Delete Feature procedure in Section 2.6: Data
Management of the Reference Manual.
You can also manually delete results from the Test Results screen, but expect
performance delays. For more information, see the Deleting a Test Result procedure.

C73199-AA
4.4: Managing Test Results UniCel DxI Operator's Guide
Copying Test Use this procedure to copy test results to a USB flash drive or a 3.5-inch high density
Results to a disk.
Disk or Flash The UniCel DxI system writes test result data into a comma-separated field format
Drive that can be imported into a PC-based spreadsheet program. The following data is
presented in the order indicated:
1. Patient ID 2. Sample ID 3. Rack

4. Verify 5. Test name 6. Interpretation
7. Result 8. Units 9. Comp. time
10. Flags 11. LIS 12. Instrument
13. RLU 14. Pipettor 15. Sample type
16. Sample priority 17. Test ID 18. Reag. pack lot number
19. Reag. pack serial number 20. Dilution 21. Calibrator levels
22. Sample comments 23. Sample load date/time 24. DxC send status
25. Dil. pack lot number 26. Dil. pack serial number
NOTE
If a plus sign (+) is displayed in the Entries field of the Test Results screen,
refresh the screen to be sure you are searching the most current data. For more
information, see the Refreshing the Test Results Screen procedure in Section 4.1:
Test Results Overview.
System mode: Ready Not Ready

1. From the Test Results screen, locate a group of test results to copy, or apply a
different filter to change the displayed results from which to locate and copy. For
more information, see the Applying a Test Result Filter procedure in Section 4.2:
Test Result Filters.
 (Optional) To locate a specific test result to copy, select Find F2. For more
information, see the Finding a Test Result procedure in Section 4.3: Reviewing
Test Results.
 (Optional) Select a single test result or a group of results. For more information,
see the Selecting Test Results procedure in Section 4.1: Test Results Overview.
NOTE
If you select a group of results and then select Copy to Disk F6, you must select
the Current Selection option in the window to copy all selected results.
Otherwise, only the result with the Arrow button is copied.

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2. Insert the flash drive or disk into the PC.

• To copy data to a USB flash drive, insert a flash drive into a port on the front
of the PC. If the front of the PC does not contain a USB port, use a port on the
back of the PC.
NOTE
For UniCel DxI instruments set up to perform system backups using a USB flash
drive, the backup drive might already be in one of the USB ports on the back of
the PC. Use a different flash drive to copy data. Do not disturb the flash drive
used for backups when inserting and removing the flash drive for copying data.
• To copy data to a 3.5-inch disk, insert a disk into the 3.5-inch disk drive of
the PC.
3. Select Copy to Disk F6. A default file name and extension are provided in the
File Name field of the Copy to Disk window.
2107B.bmp
File Name (Field) Displays the default file name and extension of the test
results to be copied. You can delete the name and enter a new
name.
Drive (List) Select the drive to which data should be copied.
Current (Option) Select to copy one selected test result to the storage
Result media.
Figure 4-13 Copy to Disk (Test Results) Window Descriptions

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Current (Option) Select to copy one or more selected test results to the
Selection storage media.
All (filtered (Option) Select to send all the test results in the current filter to
results) the storage media.
Format Disk (Box) Select to format a disk. Formatting a disk prepares it for
reading and writing data. This option is not available for flash
drives.
Figure 4-13 Copy to Disk (Test Results) Window Descriptions
4. Confirm that the correct drive is selected from the Drive list, or select a different
drive.
NOTE
Unless directed by Technical Support, do not copy data to the C: Console PC
drive or any drive labeled BACKUPDRIVE.
 (Optional) To change the default file name, enter a name and file extension for
the data file in the File Name field of the Copy to Disk window.
• The system supplies a default file name based on the date and time and a .csv
(comma delimited) extension.
• If the file name already exists on the disk or flash drive, the system displays a
warning message. To overwrite the existing file, select Yes F1. To rename
the new file, select Cancel F8.
5. Select a Copy what option.
• For the Current Result and the Current Selection options, one or more
results must be selected on the Test Results screen.
 (Optional) If the 3.5-inch disk is not formatted, select the Format disk box.
6. Select OK F1.
A progress window is displayed.
• To stop the copy process at any time, select Cancel F8.

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7. If the flash drive or disk becomes full before the copy process is complete, the
system displays a status message.
• For a USB flash drive, clear sufficient space on the drive, or copy the files to
a different flash drive.
• For a 3.5-inch disk:
- Remove the disk and label it with the data file names.
- Insert another disk, and select OK F1.
The system automatically names the file on the new disk the same as the file on
the first disk, and adds a disk number to the end.
Example
If two disks are required to copy a test result file, and you name disk
one mydata.csv, the system names disk two mydata(2).csv.
8. When the copy process is complete, the progress window closes. Remove the
flash drive or disk from the PC and label it.
NOTE
If you will be using one flash drive or disk to copy multiple files, you can leave it
in place for the next copy operation. Be sure to keep track of the file names so you
can correctly label the flash drive or disk when you remove it.

C73199-AA
Test Results
Are
results to be No Do you want a No
copied specific result?
displayed?
Yes Yes
Insert a 3.5-inch disk Find F2 Filter F1

into the disk drive or a USB
flash drive into the USB port
Find Filter
Apply filter
(Optional) Enter one of the four options
and sort orders
Select one or more results
Find Next F1 OK F1
Copy to Disk F6
Copy to Disk
• Confirm or change
the file name
• Select a drive from
the Drive list
• Select a Copy What option
(Optional)
For 3.5-inch disks
select Format disk
OK F1
2038C.wmf
Figure 4-14 Copying Test Results to a Flash Drive or Disk Flowchart

C73199-AA
Sending Test Use this procedure to manually send test results to the LIS if one or more of the
Results to the following circumstances applies:
LIS • The Auto Send to LIS option is set to Off or to Send Only Auto-Verified
Results. For more information, see Section 2.5: LIS Setup in the Reference
Manual.
• The LIS fails to receive the test results that were sent.
• The test results were on hold while the LIS was offline, and now the LIS is
back online.

1. From the Test Results screen, locate a group of test results to send to the LIS, or
apply a different filter to change the displayed results from which to locate and
send. For more information, see the Applying a Test Result Filter procedure in
 (Optional) To locate a specific test result to send, select Find F2. For more
Test Results.
2. (Optional) Select a single test result or a group of results. For more information,
see the Selecting Test Results procedure in Section 4.1: Test Results Overview.
NOTES
• You do not need to select results to send all of the results or all of the failed
results in the applied filter.
• If you select a group of results and then select Send to LIS F5, you must
select the Current Selection option in the window to send all selected
results. Otherwise, only the result with the Arrow button is sent.

C73199-AA
3. Select Send to LIS F5.
2108A.bmp
Current (Option) Select to send one selected test result to the LIS.
Result
Current (Option) Select to send one or more selected test results to the
Selection LIS.
Resend LIS (Option) Select to resend all of the test results with an LIS
Fail status of Fail in the current filter to the LIS.
All (filtered (Option) Select to send all the test results in the current filter to
results) the LIS.
Figure 4-15 Send to LIS Window Descriptions
4. Select an option from the Send what list in the Send to LIS window.
• For the Current Result and the Current Selection options, one or more
results must be selected.
• For the Resend LIS Fail or the All (filtered results) options, the system
sends the results from the current filter.
5. Select OK F1.
NOTE
If tests continue to be added or removed from the filter, you may need to refresh
the screen before results can be sent. For more information, see the Refreshing the
Test Results Screen procedure in Section 4.1: Test Results Overview. Then repeat
this procedure.

C73199-AA
6. Monitor the status of the test results sent to the LIS by viewing the LIS column of
the Test Results screen.
• If the LIS successfully receives results, the LIS status changes to Accepted.
• If the LIS does not successfully receive the results, the LIS status changes to
Failed. The system records the event in the Event Log and the Event Log
button turns red. Contact Technical Support for assistance.
Test Results
Are results
to be sent
No Do you want a No
specific result?
displayed?
Yes Yes
Find F2 Filter F1
(Optional)
Find Filter
Send to LIS F5 Apply filter

Enter one of the four options
and sort orders
Send to LIS FInd Next F1 OK F1
Select a Send What option.
OK F1
Monitor transmission
2070B.wmf
Figure 4-16 Sending Test Results to the LIS Flowchart

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Deleting a Use this procedure to delete patient and QC test results from the database.
Test Result
NOTES
• You need the system password to use this feature. If you do not know the
password, contact your lab supervisor. For more information about
passwords, see the Changing the System Password procedure in Section 2.2:
System Setup of the Reference Manual.
• Deleting test results removes the data permanently from the database.
• You cannot delete calibrator or maintenance results with this procedure.
• User interface performance is diminished while tests are being deleted using
this procedure. To delete test results automatically, use the Auto-Delete
feature. For more information, see the Setting Up the Auto-Delete Feature
procedure in Section 2.6: Data Management of the Reference Manual.
System mode: Ready Not Ready

1. From the Test Results screen, locate a group of test results to delete, or apply a
different filter from which to locate and delete results. For more information, see
the Applying a Test Result Filter procedure in Section 4.2: Test Result Filters.
 (Optional) To locate a specific test result to delete, select Find F2. For more
Test Results.
2. (Optional) Select one or more results. For more information, see the Selecting
Test Results procedure in Section 4.1: Test Results Overview.
NOTE
You do not need to select results to delete all filtered results.
3. Select More Options F8, then Delete Data F3.
4. In the Password field of the password window, enter the system password. Then
select OK F1.
5. Select an option from the Delete what list of the Delete Data window.
• To delete a single selected test result, select the Current Result option.
• To delete a group of selected test results, select the Selected Results option.
• To delete all filtered test results, select the All (filtered results) option.
6. Select OK F1.
The system displays a warning message.

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7. Select Yes F1 to delete the selected results.

After you confirm your selection, a progress window is displayed as the system
deletes the test results from the system database.
Test Results
Are results
to be deleted
No Do you want a No
specific result?
displayed?
Yes Yes
Find F2 Filter F1
(Optional)
Find Filter
More Options F8 Apply filter

and sort orders
Delete Data F3
FInd Next F1 OK F1
Password
Enter your password
OK F1
Delete Data
Select option from

Delete What list
OK F1
2069B.wmf
Figure 4-17 Deleting a Test Result Flowchart

C73199-AA
4.5: Test Result Reports UniCel DxI Operator's Guide
4.5 Test Result Reports
Result information is available on four different test result reports. All of the reports
can be printed manually. Some of the reports can be set to print automatically as well.
You can customize the test result information you obtain on a report in a number of
ways. You can configure the Test Results screen to display the type and order of result
information you want on the report. You can also filter and sort test results by various
criteria to obtain the desired report. Finally, you can select which results to print on
the report.
Examples
• To print a report of all TSH results, sort the results by test name, select the
desired TSH results, and print the Selected Test Results Report.
• To print a report of all tests completed in the past 24 hours, apply the All
Samples Loaded Between... filter to the test results, select the Past 24
hours option for the date and time, and print the Selected Test Results
Report.

C73199-AA
UniCel DxI Operator's Guide 4.5: Test Result Reports
Test Result Four test result reports are available on the UniCel DxI system.
Report
Descriptions NOTE
If present, dilution factors displayed on the Sample Report, Patient Report, and
Continuous Sample Report are manual dilution factors typed during a manual test
request. Onboard dilution and Special Dilution information is not included on test
result reports. For more information, see Onboard Dilutions in Section 1.3:
Sample Processing Theory of the Reference Manual.
Sample Report
The Sample Report (see Figure 4-18) contains all test result information associated
with a sample ID.
If two or more tests associated with the same sample ID are selected on the Test
Results screen, and you manually print the Sample Report, the report prints only once.
For more information, see the Printing Test Result Reports procedure.
If set to print, STAT sample results automatically print in this format. For more
information, see the Setting Up Reports procedure in Section 2.2: System Setup of the
Reference Manual.
Patient Report
The Patient Report (see Figure 4-19) contains all test result information associated
with a patient ID.
If two or more tests associated with the same patient ID are selected on the Test
Results screen and you manually print the Patient Report, the report prints only once.
For more information, see the Printing Test Result Reports procedure.
Selected Test Results Report

The Selected Test Results Report (see Figure 4-20) contains test result information for
all filtered or selected test results.
This report format mirrors the configuration of the Test Results screen. To print this
report, see the Printing Test Result Reports procedure.
Continuous Sample Report

The Continuous Sample Report (see Figure 4-21) contains test result information for
patient and QC samples organized according to completion time. The report prints
automatically if you set up the Auto Print feature. For more information, see the
Setting Up Reports procedure in Section 2.2: System Setup of the Reference Manual.

C73199-AA
If set to print, the report prints automatically when there are enough completed test
results to fill a page, when all processing is complete, or when all tests for a STAT
sample tube are complete.
NOTE
Requested test results that cause reflex tests are printed on two Continuous
Sample Reports. The first report prints only the requested test results. When the
reflex tests are complete, the report prints a second time with the reflex results
and the requested results.
Alternatively, you can manually print the report as samples are completed. For more
information, see the Printing the Continuous Sample Report procedure.
Calibration and maintenance results are not included on this report. For more
information, see the Printing a Calibration Data Report in Section 5.4: Reviewing
Calibration Data or see the Displaying and Printing System Check Result Data
procedure in Section 4.4: System Check Routines in the Reference Manual.

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Laboratories, Inc.
Laboratory A
123 Lake Street
Sample Report Townsville, ST 33333
UniCel DxI 800, Access Immunoassay System 101-555-2323 ext. 109
S/N 610240 B. Beaulieu
Sample ID: 23345128 Sample Type: Serum

Patient ID: 555-56-9898
Name: Follett F.
Sex: Male
Birth date: 10-15-1944
**STAT**
Instrument: 501240
Test Name Result Ref. Range Flags Dilution Completed
CK-MB >293 ng/mL 0.6-6.3 OVR 1 10-10-02 07:30 PM
MYO No Value 17.4-105.7 QNS 1 10-10-02 07:27 PM
MYO(2) 39.6 ng/mL 17.4-105.7 1 10-10-02 07:16 PM
Instrument: 501240
Test Name Result Ref. Range Flags Dilution Completed
FreePSA% 16.6
freePSA 1.58 ng/mL 1 08-08-02 02:45 PM
PSA-Hyb 9.53 ng/mL 0.000-4.000 1 08-08-02
02:15 PM
Comments: Cloudy sample.
OVR = Over range, QNS = Insufficient Sample

Page 1 of 1
Technologist _____________________________________ Printed 10-10-02 10:28 PM
2040B.bmp
Figure 4-18 Sample Report Example

C73199-AA
Laboratories, Inc.
Laboratory A
123 Lake Street
Patient Report Townsville, ST 33333
S/N 610240 R. Goldman
Patient ID: 555-56-9898

Name: Feldmann, A.
Sex: Male
Birth Date: 10-15-1944
**STAT**
Sample ID: 23345128Dil Sample Type: Plasma Dilution: 10
Test Name Result Ref. Range Flags Completed
CK-MB 939.0 ng/mL 0.5-5.0 ORH 10-10-02 08:18 PM
Comments: Sample slightly cloudy.
**STAT**
Sample ID: 23345128 Sample Type: Plasma
CK-MB >293 ng/mL 0.5-5.0 OVR 10-10-02 07:30 PM
MYO No Value 14.3-65.8QNS 10-10-02 07:27 PM
MYO(2) 125.8 ng/mL 14.3-65.8ORH 1 0-10-02 07:27 PM

FreePSA% 16.6 08-08-02 02:44 PM
freePSA 1.58 ng/mL 08-08-02 02:45 PM
PSA-Hyb 9.53 ng/mL 0.000-4.000 ORH 08-08-02 02:15 PM
Comments: Copy of results to Dr. Bennett.

PSA-Hyb(2) 3.71 ng/mL 0.000-4.000 02-02-02 12:03 PM
PSA-Hyb 3.86 ng/mL 0.00-4.000 02-02-02 11:15 AM
OVR = Over range, QNS = Insufficient Sample

Page 1 of 1
Technologist ____________________________________ Printed 10-10-02 10:25 PM
2039B.bmp
Figure 4-19 Patient Report Example

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Laboratories, Inc.
Laboratory A
123 Lake Street
Selected Test Results ReportUniCel DxI 800, Townsville, ST 33333
Access Immunoassay System 101-555-2323 ext. 109
S/N 610240 V. Flores
Filter: All Samples - Sorted by Sample ID Then by Test Name
Sample ID Rack Test Name Result Flags LIS Pipettor Comp. Time
13501350 48 Ferritin 404.1 ng/mL Accepted 1 10/10/02 06:40
13501350 48 FOL2 4.34 ng/mL Accepted 3 10/10/02 06:32
13501350 48 VitB12 354 pg/mL Accepted 4 10/10/02 06:38
19953581 504 freePSA Supply Wait 1
19953581 504 PSA-Hyb Supply Wait 3
23345128 106 CK-MB >293 ng/mL OVR Accepted 4 10/10/02 19:30
23345128 106 MYO 39.6 ng/mL Accepted 2 10/10/02 19:27
23345128 106 MYO(2) No Value QNS Accepted 1 10/10/02 19:27
25688888 48 VitB12 103 pg/mL Failed 2 10/10/02 06:41
39422493 505 MYO 0.00 ng/mL Failed 2 10/10/02 14:03
78910116 502 FOL2 Cancelled SYS 3 10/10/02 10:46
OVR = Over range, QNS = Insufficient sample, SYS = System error

Page 1 of 1
Technologist ________________________________ Printed 10/10/02 20:07
2041B.bmp
Figure 4-20 Selected Test Results Report Example

C73199-AA
Laboratories Inc.
4-56
Laboratory A
123 Lake Street
Continuous Sample Report Townsville, ST 33333
S/N 601240 Jane Smith
___________________________________________________________________________________________________________________________________
Sample ID Type
4.5: Test Result Reports
Rack/Pos Patient/Lot ID Dilution Test Result Ref. Range Flags RLUs Completion
________________________________________________________________________________________________________________________________
122/1 23345128 Plasma
**STAT** 555-56-9898 1 CK-MB >293 ng/mL 0.000 - 4.000 OVR 18445200 10-10-02 06:01 PM
MYO 39.6 ng/mL 14.3-65.8 337183
10-10-02 05:58 PM
MYO(2) No Value 14.3-65.8 QNS No Value
10-10-02 05:48 PM
Dig No Value NCR 853012
10-10-02 06:07 PM
Comments: All tests ordered by Dr. Olson.

Patient Name: Feldmann, A.
___________________________________________________________________________________________________________________________________
115/1 236-79 Serum
126-00-5441 PSA-Hyb 14.82 ng/mL0.000 - 4.000 2606765 10-10-02 06:01 PM
freePSA 12.24 ng/mL 6390525 10-10-02 06:00 PM
FreePSA% 82.6 No Value 10-10-02 06:01 PM
Comments: Notify Dr. Flores in Urology when tests are complete.

Patient Name: Follett, F.
___________________________________________________________________________________________________________________________________
115/2 999 Serum
Figure 4-21 Continuous Sample Report Example

669-52-5551 VitB12 170 pg/mL180.000 - 914.000 2138570 10-10-02 06:17 PM
Ferritin 61.5 ng/mL11.000 - 340.000 678573 10-10-02 06:13 PM
FOL2 4.39 ng/mL 564312 10-10-02 06:17 PM
Patient Name: Aminu, A.
___________________________________________________________________________________________________________________________________
RFX = Reflexed test; OVR = Over range; QNS = Insufficient sample; NCR = No curve;
Page 1 of 1
Technologist __________________________________________ Printed 10-10-02 06:19 PM

UniCel DxI Operator's Guide
C73199-AA
2042B.bmp
Printing Test Use this procedure to print a test result report.

Result
NOTES
Reports
• To print the Continuous Sample Report, see the Printing the Continuous
Sample Report procedure.
• If a result has not yet been calculated, the report prints the test status instead
of the result. For more information, see the Test Status topic in Section 3.5:
Monitoring Sample Progress.
• Demographic information, which includes Name, Birth Date, and Sex can be
changed from the LIS after a test result is calculated. If you reprint a Patient
Report after making a change, the information will be different than a report
printed earlier.

1. From the Test Results screen, locate a group of test results to print, or apply a
different filter to change the displayed results from which to locate and print. For
more information, see the Applying a Test Result Filter procedure in Section 4.2:
Test Result Filters.
 (Optional) To locate a specific test result to print, select Find F2. For more
Test Results.
 (Optional) Select one or more results. For more information, see the Selecting
Test Results procedure in Section 4.1: Test Results Overview.
2. Select Print F7 and then select Report F1.
0623B.bmp

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Report (List) Select the type of test result report to print.

Current (Option) Select to print one selected test result.
Result
Current (Option) Select to print one or more selected test results.
Selection
All (filtered (Option) Select to print all the test results on the current Test
results) Result screen.
Figure 4-22 Print (Test Result Reports) Window Descriptions
3. Select the type of report you want to print from the report list. For more
information, see the Test Result Report Descriptions topic.
4. Select the appropriate option from the Print What list.
5. Select OK F1.
The system sends the report to the printer. A progress window is displayed. Select
Cancel F8 to stop the print job at any time.

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Test Results
Are results
to be printed
No Do you want a No
specific result?
displayed?
Yes Yes
(Optional) Find F2 Filter F1

Select one or more results to
print
Find Filter
Print F7 Apply filter

and sort orders
Report F1
FInd Next F1 OK F1
Print
Select a report and a

Print What option
OK F1
2071B.wmf
Figure 4-23 Printing Test Result Reports Flowchart

C73199-AA
Printing the Use this procedure to manually print the Continuous Sample Report. For a description
Continuous of the Continuous Sample report, see the Test Result Report Descriptions topic.
Sample Most operators will wait for the Continuous Sample Report to print automatically. To
Report set up the report to print automatically, see the Setting Up Reports procedure in
Section 2.2: System Setup of the Reference Manual. However, use this procedure if
you need to print the report immediately for completed samples not yet printed.
NOTES
• Incomplete tests do not print on the Continuous Sample Report.
• Results print on the Continuous Sample Report only once. If a result was
printed manually or automatically on the Continuous Sample Report and you
want to reprint the result, you must choose one of the other three report
formats.

1. From the Test Results screen, select Print F7.
2. Select Completed Samples F2.

The system sends the report to the printer.

C73199-AA
UniCel DxI Operator's Guide 5: Assay Calibration
5 Assay Calibration
5.1 Assay Calibration Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Calibration Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
Applying a Calibration Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Deleting Calibrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
Printing the Calibration Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
5.2 Setting Up Calibrators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10
Calibrator Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11
Adding a Calibrator Lot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12
Scanning the Calibrator Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16
Editing a Calibrator Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-17
Deleting a Calibrator Lot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-18
5.3 Running a Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-19
Test Requests Screen for Calibration. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-20
Entering Calibration Requests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-22
Changing the Reagent Lot for a Calibration . . . . . . . . . . . . . . . . . . . . . . . . . 5-25

C73199-AA
5: Assay Calibration UniCel DxI Operator's Guide
5.4 Reviewing Calibration Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-26
The Most Recent Calibration Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-27
Calibration Data Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-27
Viewing Calibration Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-32
Switching the Active with the Previous Active Calibration . . . . . . . . . . . . . 5-32
Entering, Viewing, or Editing a Calibration Comment . . . . . . . . . . . . . . . . . 5-33
Printing a Calibration Data Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-33
5.5 Troubleshooting Failed Calibrations . . . . . . . . . . . . . . . . . . . . . . . 5-35
Calibration Failure Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36
Assay Calibration Problems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37

C73199-AA
UniCel DxI Operator's Guide 5.1: Assay Calibration Overview
5.1 Assay Calibration Overview
Assay calibrations establish values that the system uses to calculate test results for
patient and quality control (QC) samples. Calibrations are generated from tests run on
samples with stated concentrations of analyte. The samples used to calibrate the assay
are known as calibrators.
NOTE
Whether you use calibrators or controls to calibrate an assay, the UniCel DxI
system and this documentation use the term calibrator to refer to these
components.
Calibrations either pass or fail according to the acceptance criteria defined in the assay
protocol file (APF). When a calibration passes, it becomes the active calibration for
processing patient and QC test requests. An active calibration remains active, even if
it is expired, until you run another calibration that passes, you switch to a previous
active calibration, or you delete the calibration. If there is no active calibration for an
assay, RLUs are reported, but no patient or QC test results are obtained.
Calibrations expire according to parameters defined for the assays in the APF. If a
calibration does not exist or is expired and you request a test for the assay, the system
prompts you with the following indicators to calibrate the assay before running the
test:
• The Supplies Required button turns yellow
• The Amber status indicator light blinks
• The Console panel icon is lit on the system status panel (UniCel DxI 800
instrument only)
You can process tests with expired calibrations by overriding the condition, however
the results will be flagged. For information about overriding, see Section 2.1: Supply
and Supply Conditions Overview.
When a calibrator lot expires, it remains available for calibration until you delete the
lot from the system. You can request a calibration using an expired calibrator lot. You
can also request QC and patient tests using an active calibration curve based on a
calibrator lot that was or has since expired. When an expired lot is used, results for

C73199-AA
5.1: Assay Calibration Overview UniCel DxI Operator's Guide
calibration, QC, and patient tests report with the non-fatal CLX flag. For more
information on result flags, see Section 4.3: Reviewing Test Results.
For failed calibrations, the failure code is displayed on the Calibration Data screen
and a caution event is reported on the Event Log. For help on how to interpret or
troubleshoot failed calibrations, see Section 5.5: Troubleshooting Failed Calibrations.
For information about assay calibration theory, see Section 1.4: Assay Calibration
Theory in the Reference Manual.
Set up calibrators
Run a calibration
• Prepare samples
• Request the calibration
• Load racks
Did the No Review calibration data and

calibration troubleshoot
pass?
Yes
Use the calibration to

process samples
Repeat calibration before it

expires
2127C.wmf
Figure 5-1 Assay Calibration Overview Flowchart

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Calibration Use the Calibration screen to:

Screen • Add and delete calibrator lots or edit calibrator levels
• View, print, or delete calibration data
• Print a calibration report
2128B.bmp

Entries (Field) Displays the total number of calibrations that meet the filter parameters.
Assay Buttons (Buttons) Displays the assay calibrations that meet the filter parameters. Each
Assay button is identified by the test name and reagent lot used for the calibration.
Select an Assay button to review or to delete the assay calibration.
Filter (Button) Select to apply a different calibration filter or to change the sort order. For
F1 more information, see the Applying a Calibration Filter procedure.
Figure 5-2 Calibration Screen Descriptions

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Review Data (Button) Select to review the Calibration Data screen for a selected Assay button.
F2 The data for the active calibration is displayed. If no calibration has passed the
acceptance criteria, the system displays the last failed calibration. For more
information, see Section 5.4: Reviewing Calibration Data.
Calibrator Setup (Button) Select to display the Calibrator Setup screen. From this screen, you can
F5 set up, edit, or delete calibrators. For more information, see Section 5.2: Setting Up
Calibrators.
Delete (Button) Select to delete a selected calibration and its Assay button. All of the
F6 calibration data for the selected test and reagent lot is removed from the system.
For more information, see the Deleting Calibrations procedure.
Print (Button) Select to print the Calibration Report, which lists assay calibrations
F7 according to the applied filter parameters. For more information, see the Printing
the Calibration Report procedure.
Figure 5-2 Calibration Screen Descriptions (continued)
Applying a Use this procedure to apply a different filter or sort order to the Assay buttons on the
Calibration Calibration screen.
Filter System Mode: Any Mode
1. From the Calibration screen, select Filter F1.
0850C.bmp
Filter (Options) Select either the filter that displays all assay
calibrations or the filter that displays only those assay
calibrations with reagent on board the instrument.
Figure 5-3 Filter (Calibration) Window Descriptions

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Ascending (Box) Select to sort the Assay buttons in ascending,

order. Clear the box to sort the Assay buttons in
descending order.
Assay calibrations are sorted by test name, then by
reagent lot.
Figure 5-3 Filter (Calibration) Window Descriptions (continued)
2. Select one of the filter options:

• All Calibrations - Displays the active calibrations for each assay, or the most
recent failed calibration if a calibration has not yet passed.
• On-board Reagent Lots - Limits the calibrations displayed to those with
reagent on board the instrument.
3. Select the sort order for the filtered calibrations in the Ascending box.
Calibrations are sorted by test name, then by reagent lot.
• To sort in ascending order, select the box.
• To sort in descending order, clear the box.
4. Select OK F1 to apply the filter and display the calibrations that meet the filter
parameters on the Calibration screen.
Deleting Use this procedure to delete the assay calibration data for a specific reagent lot. Delete
Calibrations calibrations that are no longer needed, such as expired calibrations for reagents that
will not be calibrated again. To save calibration data before you delete it, see Copying
Test Results to a Disk or Flash Drive in Section 4.4: Managing Test Results.
NOTE
If you have no further need for the calibrator lot or for the assay, delete the
calibrator lot instead of the calibration. For more information, see the Deleting a
Calibrator Lot procedure in Section 5.2: Setting Up Calibrators.

1. On the Calibration screen, locate the test name and reagent lot of the assay
calibration to be deleted. If needed, apply a different filter. For more information,
see the Applying a Calibration Filter procedure.
2. Select the Assay button and then select Delete F6.

3. Confirm your selection and then select OK F1 to delete all of the data for the
selected calibration from the instrument.

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Printing the The Calibration Report is a list of assay calibrations, sorted first by test name and then
Calibration by reagent lot. Use this procedure to print the report.
Report System Mode: Any Mode
1. On the Calibration screen, confirm that the calibrations you intend to print are
included in the current filter. If needed, apply a different filter. For more
information, see the Applying a Calibration Filter procedure.
2. Select Print F7 to print the report.

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Laboratories, Inc.
Laboratory A
123 Lake Street
Calibration Report Townsville, ST 33333
Filter: All Calibrations - Ascending Sorted by Test Name and Reagent Lot
Test Name Reagent Lot

CK-MB 900130
Ferritin 000125
FRT4 000111
FRT4 012650
GToxo 022888
GToxo 044777
IgM-Toxo 059940
IgM-Toxo 098564
MRub 091573
MRub 963258
MYO 055555
Rub-IgG 011111
Rub-IgG 988888
TBhCG2 021654
TBhCG2 085614
TotT3 002698
TSH 074523
TSH 987785
Page 1 of 1
Technologist__________________________________________ Printed 03/03/10 12:43 PM
2131C.bmp
Figure 5-4 Calibration Report Example

C73199-AA
5.2: Setting Up Calibrators UniCel DxI Operator's Guide
5.2 Setting Up Calibrators
Before you can request a calibration, the calibrator must be set up on the system. A
calibrator is identified on the system by the test name and the lot number.
NOTE
Whether you use calibrators or controls to calibrate an assay, the UniCel DxI
system and this documentation use the term calibrator to refer to these
components.
All Access Immunoassay System calibrators include calibrator cards in the

packaging. When adding a calibrator to the system, you scan the bar coded
information on the calibrator card with the PC bar code reader. The test name,
calibrator lot number, and calibrator expiration date are added to the system.
Some calibrators include an additional calibrator card in the packaging for a

secondary test that can be run using the same reagent pack. Scan the calibrator card
for each test you will run. Scanning both calibrator cards adds the calibrator to the
system for each test. Both tests must then be individually calibrated.
Most calibrators are multi-level. They contain more than one vial, and each vial
contains a different concentration or level of analyte. When you add a multi-level
calibrator to the system, all calibrator levels are added as one calibrator lot.
To correct calibrator information that is in error, you can edit some calibrators on the
system. If you cannot edit a calibrator that you need to change, delete the calibrator
and add it again.
When a calibrator lot is expired, your supply has run out, or you have no further need
for the assay on the system, delete the calibrator. All data associated with the
calibrator lot is removed from the system.
For information about requesting a calibration, see Section 5.3: Running a

Calibration.

C73199-AA
UniCel DxI Operator's Guide 5.2: Setting Up Calibrators
Calibrator Use the Calibrator Setup screen to:

Setup Screen • View calibrator lot and expiration information
• Add and delete calibrator lots or edit calibrator levels
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Calibrator List (List) Displays information about all of the calibrator lots set up on the system. For
each calibrator, the following information is displayed:
• Test - Displays the assay test name.
• Calibrator Lot - Displays the calibrator lot number.
• Expiration - Displays the expiration date for the calibrator lot.
Select a calibrator to edit or delete the calibrator lot.
Add Calibrator (Button) Select to add a calibrator lot to the system.
F1
Figure 5-5 Calibrator Setup Screen Descriptions

C73199-AA
Edit Calibrator (Button) For quantitative and semi-quantitative assays only. Select to edit the
F2 calibrator level information for one or more calibrator levels for a selected
calibrator lot. For more information about assay types, see Section 1.4: Assay
Calibration Theory in the Reference Manual.
Delete Calibrator (Button) Select to delete a selected calibrator lot and to remove all data associated
F6 with it from the system.
NOTE
You need the system password to use this feature.
Figure 5-5 Calibrator Setup Screen Descriptions (continued)
Adding a Use this procedure to add a calibrator lot to the system for an individual test. If you
Calibrator Lot will be running a secondary test with this calibrator, add the calibrator lot again with
the second calibration card.
NOTE
This procedure refers to quantitative, semi-quantitative, and qualitative assays.
For more information about these types of assays, see Section 1.4: Assay
Calibration Theory in the Reference Manual.

1. From the Calibration screen, select Calibrator Setup F5.

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2. From the Calibrator Setup screen, select Add Calibrator F1 to display the Add
Calibrator window.
2162A.bmp
Bar Code (Field) Enter the bar code information from the calibrator card using the PC bar
code reader. Always scan the bar code at the top of the card first. For some
calibrators, all of the calibrator information is automatically added to the window.
For other calibrators, you must scan each bar code on the card.
NOTES
• If you cannot scan the bar code, type the characters printed underneath the
bar code and press [Enter].
• This is the only field in which you can enter information in this window
(and the only field that can be edited in the Edit Calibrator window).
Calibrator Name (Field) Displays the name of the calibrator, based on the bar code entry.
Lot Number (Field) Displays the calibrator lot number, based on the bar code entry.
Expiration Date (Field) Displays the calibrator expiration date, based on the bar code entry.
Figure 5-6 Add Calibrator Window Descriptions

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Calibrator Level (List) Displays the following information for each calibrator level after bar code
List entry:
• Test Name - Displays the assay test name.
• Level - Displays the calibrator level.
• Stated Concentration - For quantitative and semi-quantitative assays only,
displays the concentration of analyte material in the calibrator level, as stated on
the calibrator card.
• Units - For quantitative and semi-quantitative assays only, displays the units of
measure for the calibrator level.
For more information about quantitative and semi-quantitative assays, see
Section 1.4: Assay Calibration Theory in the Reference Manual.
Figure 5-6 Add Calibrator Window Descriptions (continued)
3. Use the PC bar code reader to scan the bar code at the top of the calibrator card.
The scanned information displays in the Bar Code field. For more information,
see the Scanning the Calibrator Card procedure.
For some multi-level calibrators (usually qualitative assays), the system automatically
adds all of the calibrator levels with their stated analyte concentrations and units to the
calibrator level list.
NOTE
If you cannot scan the bar code at any step of this procedure, you can type the
characters printed underneath the bar code and press [Enter].
4. If the calibrator is multi-level and the information for each level is not displayed
in the calibrator level list (usually quantitative assays), scan each bar code on the
card.
5. Confirm that the information in the Add Calibrator window is correct.

• If the information is correct, select OK F1 to add the calibrator lot to the
system.
• If the information is not correct, scan the bar code again. As an alternative,
type the bar code information and press [Enter].

C73199-AA
Calibration
Calibrator Setup F5
Calibrator Setup
Add Calibrator F1
Add Calibrator
When typing bar
code information, Scan the calibrator
press [Enter] after bar code information
each bar code
Is the
calibrator No
information
correct?
Yes
OK F1
2135B.wmf
Figure 5-7 Adding a Calibrator Lot Flowchart

C73199-AA
Scanning the All Access Immunoassay System calibrator supplies include calibrator cards with the
Calibrator bar coded information required for adding or editing calibrator setup information. Use
Card this procedure to scan a calibrator card with the PC bar code reader.

1. Begin this procedure at the appropriate Add or Edit Calibrator window. For more
information, see the Adding a Calibrator Lot or Editing a Calibrator Level
procedure.
2. Remove the PC bar code reader from the holder attached to the PC
(UniCel DxI 800 instrument: see Figure 1-1; UniCel DxI 600 instrument: see
Figure 1-2).
3. Set the calibrator card on a flat surface, such as the area to the right of the system
status panel.
4. Hold the PC bar code reader approximately 1-8 inches (2.5-20.3 cm) above the
card and aim the reader straight down at the card.
5. Starting with the bar code at top of the card, squeeze and hold the trigger.
6. Center the red light (indicating the scanning area) within the lines of the bar code
and release the trigger. When a bar code is read successfully, the bar code reader
beeps and the scanned information is displayed in the Bar Code field.
7. Confirm that the information in the Add or Edit Calibrator window is correct.
• If the information is not correct, and the calibrator card is not damaged in any
way, scan the bar code again.
• If the calibrator card is damaged or the bar code is not readable, type the
characters printed underneath the bar code and press [Enter].
8. Continue adding or editing calibrators according to the respective setup

procedure, and then return the bar code reader to its holder.

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Editing a Use this procedure to correct a problem with the calibrator level information for a
Calibrator quantitative or semi-quantitative assay.
Level
NOTES
• To edit the calibrator information for a qualitative assay, or to change any
information that cannot be edited, delete the calibrator and then add the
calibrator again.
• For more information about quantitative, semi-quantitative, or qualitative
assays, see Section 1.4: Assay Calibration Theory in the Reference Manual.

2. From the Calibrator Setup screen, select the calibrator to be edited.
3. Select Edit a Calibrator F2. The selected calibrator is displayed in the Edit
Calibrator window.
NOTE
The Edit Calibrator window is identical to the Add Calibrator window.
4. Use the PC bar code reader to scan the bar code into the Bar Code field from the
calibrator card. For more information, see the Scanning the Calibrator Card
procedure.
NOTE
If you cannot scan the bar code at any step of this procedure, type the characters
printed underneath the bar code and press [Enter].
5. To correct more than one level of a multi-level calibrator, scan the bar code for
each level individually.
6. Confirm that the information in the Edit Calibrator window is correct.

• If the information is correct, select OK F1 to save the edited calibrator
information.
• If the information is not correct, scan the bar code again. As an alternative,
type the bar code information and press [Enter].

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Deleting a Use this procedure to delete a calibrator lot from the system. All data associated with
Calibrator Lot the calibrator lot, including calibrations, is removed from the system.
NOTES
passwords, see Section 2.2: System Setup in the Reference Manual.
• You cannot delete a calibrator lot that is included in a calibration request.

2. From the Calibrator Setup screen, select the calibrator to be deleted from the
system.
3. Select Delete Calibrator F6.
4. Enter the system password, then select OK F1.
5. Confirm your selection, and then select Yes F1 to delete the calibrator.

C73199-AA
UniCel DxI Operator's Guide 5.3: Running a Calibration
5.3 Running a Calibration
Each assay reagent lot must be calibrated on the instrument before it can be used to
analyze samples. The first calibration for an assay adds an Assay button to the
Calibration screen. Separate Assay buttons are added for each reagent lot. For more
information about Assay buttons and the Calibration screen, see Section 5.1: Assay
Calibration Overview.
Before calibrating an assay, be sure that the following conditions are met:
• The test is enabled on the system. For more information, see Section 3.3: Test
• An unexpired calibrator is set up for the assay. For more information, see
Section 5.2: Setting Up Calibrators.
• Sufficient unexpired reagent is loaded on the instrument. For more
information, see Section 2.7: Reagent Supplies.
Some assays require temperature restrictions. See Appendix A of the UniCel DxI
Instructions for Use manual for information on these restrictions.
You calibrate an assay by manually entering a calibration request on the Test

Requests screen, placing the calibrator samples in racks, and loading the racks on the
instrument. For more information, see Section 3.4: Loading and Unloading Racks.
All calibrator samples in a calibration request are run using the same reagent pipettor.
The system selects that pipettor from the pipettors assigned to the test. For more
information, see Section 3.3: Test Setup in the Reference Manual.
You can monitor the status of a calibration request on the Sample Manager screen.
For more information, see Section 3.5: Monitoring Sample Progress.
You can view calibration results on the Calibration Data screen. For more
information, see Section 5.4: Reviewing Calibration Data.

C73199-AA
5.3: Running a Calibration UniCel DxI Operator's Guide
Test Requests Use the Test Requests screen to:

Screen for • Enter calibration request information
Calibration • Cancel calibration requests
2161B.bmp
Rack Button (Button and Field) Displays the rack ID, and the position and sample ID of each
and container in the rack.
Enter ID Select the Rack button to enter or change the rack ID. The Enter ID field is
displayed.
Calibrator (Field) Displays the name of the calibrator selected for this calibration in the
Request Calibration window (see Figure 5-9).
Calibrator Lot (List) Displays the calibrator lot selected for this calibration. If more than one lot
exists for the calibrator, you can select an alternate lot from the list.
Figure 5-8 Test Requests (for Calibration) Screen Descriptions

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Reagent (Fields) Displays the reagent name and lot number of the oldest reagent pack on
and board that is not empty, expired, or included in another calibration request. The
Reagent Lot number of test replicates is displayed in parentheses to the right of the reagent
name.
Test (Field) Displays the test ID of the assay to be calibrated.
Change Reag. Lot (Button) Select to change the reagent lot to another on-board reagent lot. The Set
Reagent Lot window is displayed. For more information, see the Changing the
Reagent Lot for a Calibration procedure.
Rack ID (Button) Select to enter a new rack ID, or change the current rack ID. The Enter ID
F1 field is displayed on the Rack button. For more information, see the Entering
Calibration Requests procedure or see Section 3.6: Editing Test Requests.
For multi-level calibrator samples that require two racks for calibration, select to
display a menu of available Rack buttons.
First F1
Select to enter or change the first rack ID for the first four calibrator samples.
Second F2
Select to enter or change the second rack ID.
New Request (Button) Select to exit this request and to request a new test request. There are three
F3 different test request types.
information, see Section 3.3: Patient Test Requests or see Section 6.3: Running
Calibration F2
Select to request an assay calibration. For more information, see
Section 5.3: Running a Calibration.
Maintenance F3
Select to request a maintenance routine. For more information, see
Section 7.1: Maintenance Overview.
Test Results (Button) Select to display the Test Results screen. The Test Results screen begins
F4 to display test requests when the samples are aliquoted by the system. For more
information, see Section 4.3: Reviewing Test Results.
Cancel Request (Button) Select to cancel the test request and to return to the Sample Manager
F6 screen. For more information, see Section 3.6: Editing Test Requests.
Figure 5-8 Test Requests (for Calibration) Screen Descriptions (continued)

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Entering Use this procedure to request a calibration, which can consist of up to seven calibrator
Calibration samples.
Requests
NOTES
• 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. For more
information, see Section 5.2: Setting Up Calibrators, see Section 3.3: Test
Setup of the Reference Manual, or see Section 2.8: Reagent Inventory.
• You can request a calibration using an expired calibrator lot.

1. From the Sample Manager screen, select New Request F3 and then
Calibration F2 to display the Request Calibration window.
2164B.bmp
Calibrator List (List) Displays the calibrator name, the calibrator lot
number, and the lot expiration date for each calibrator set
up on the system. Expired calibrator lots are included in
the list until they are deleted.
Select a calibrator lot from the list for this calibration
request.
Figure 5-9 Request Calibration Window Descriptions
2. Select the calibrator lot for this calibration request, and then select OK F1.

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3. On the Test Requests screen, enter the rack ID in the Enter ID field and press
[Enter].
 (Optional) To enter a second rack ID, select Rack ID F1, then Second F2, and
then repeat step 3.
 (Optional) To change the calibrator lot, select another lot from the list.
 (Optional) To change the reagent lot for this calibration request, select Change
Reag. Lot. For more information, see the Changing the Reagent Lot for a
Calibration procedure.
4. Place the calibrator samples in the racks and order indicated on the Rack button of
the Test Requests screen. For more information, see the Placing Sample
Containers in Racks procedure in Section 3.4: Loading and Unloading Racks.
NOTE
If calibrator samples are not placed in the racks in the proper order, the calibration
will fail and must be requested again.
 (Optional) To request additional calibrations, select New Request F3 and then

Calibration F2. When the Request Calibration window is displayed, repeat this
procedure beginning at step 2.
5. When you are done entering calibration requests, exit the Test Requests screen.
6. Load the racks on the instrument. For information about loading racks, see
Section 3.4: Loading and Unloading Racks.

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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
2101B.wmf
Figure 5-10 Entering Calibration Requests Flowchart

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Changing the When you enter a calibration request, the system assigns the oldest reagent pack on
Reagent Lot board that is not empty, expired, or included in another calibration request. Use this
for a procedure to change the assigned reagent lot.
Calibration System Mode: Any Mode

1. From the Test Requests screen for calibrations, select Change Reag. Lot.
2. From the Set Reagent Lot window, select the reagent lot to calibrate. You can
only select from reagent lots that are on board the instrument.
3. Select OK F1 to change the reagent lot for the calibration request.

C73199-AA
5.4: Reviewing Calibration Data UniCel DxI Operator's Guide
5.4 Reviewing Calibration Data
There are three types of assay calibrations:

• Quantitative
• Semi-quantitative
• Qualitative
Each type of calibration differs in the way it calculates and reports test results. For
more information about calibration types, see Section 1.4: Assay Calibration Theory
Depending on the type of assay calibration and the parameters defined in the APF, the
system generates either a calibration curve or cutoff. A calibration curve plots the
measured RLUs of each replicate to the concentration of analyte. A calibration cutoff
establishes the point at which a result is determined clinically significant, according to
information provided in the reagent instructions for use.
NOTE
Do not use calibrator RLU values to predict test results of other samples.
You can view or print the most recent calibration data by reagent lot. Regardless of
the lot number, the most recent accepted calibration for an assay becomes the only
active calibration. For quantitative and semi-quantitative assays only, you can switch
between active and previously active calibrations.
The system stores all calibration data until you manually delete it. For more
information, see the Deleting Calibrations procedure in Section 5.1: Assay Calibration
Overview or see the Deleting a Calibrator Lot procedure in Section 5.2: Setting Up
Calibrators.

C73199-AA
UniCel DxI Operator's Guide 5.4: Reviewing Calibration Data
The Most Although all calibration data is stored on the system until you delete it, you can only
Recent view the most recent calibrations on the Calibration Data screen. For calibrations that
Calibration produce a curve, you can view data for the active, the previous active, and the last run
calibrations. For calibrations with a cutoff, you only can view data for the active and
Data
last run calibrations. Active and previous active curves can be switched. For more
information, see the Switching the Active with the Previous Active Calibration
procedure.
Active The data for the most recent calibration that passed.*
Only active calibrations are used to evaluate patient samples.
Previous The data for the calibration that was previously the active
Active calibration. You can switch the previous active calibration with
the active calibration.
Last Run The results of the most recent calibration request, which either
passed or failed.
If the last run calibration passed, the same data is displayed for
both the active and the last run calibration.*
Table 5-11 The Most Recent Calibration Data

* Unless you switch the active with the previous calibration.
Calibration Use the Calibration Data screen to:

Data Screen • View or print recent calibration data
• Record or view comments about a calibration
• Switch between the active and the previous active calibrations (for some
assays)
NOTE
The format of the Calibration Data screen differs for calibration results that are
expressed as a curve or a cutoff. Information about both formats is included with
the screen descriptions.

C73199-AA
2130A.bmp
Test (Field) Displays the test name of the calibrated assay.

Reagent Lot (Field) Displays the lot number of the reagent used to calibrate the assay.
Calibrated (Field) Displays the date and time the calibration was completed.
(for curves only)
Established (Field not shown) Displays the date and time the calibration was completed.
(for cutoffs only)
Expiration (Field) Displays the date and time the calibration expires, as defined in the assay
protocol file.
Cutoff (Field not shown) Displays the cutoff value in RLUs established by this calibration
(for cutoffs only) for evaluating test results.
Figure 5-12 Calibration Data Screen Descriptions

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Units (Field) Displays the units of measure for the calibrator sample type defined in the
APF. The calibrator sample type cannot be changed.
• For calibration curves, the units for the calibrator sample type can be edited for
the test. For more information, see Section 3.3: Test Setup in the Reference
Manual.
• For calibration cutoffs, the units are defined in the APF and cannot be changed.
Curve (Field) Displays which of the recent calibrations is displayed on the screen. For
more information, see The Most Recent Calibration Data topic.
Status (Field) Displays the status of the calibration request:
• Passed - The calibration results are within the acceptance criteria defined in the
APF. The calibration is either active or was previously active.
• Failed - The calibration results are not within the acceptance criteria defined in
the APF. The previous calibration remains active and this calibration is the last
run.
Reason (Field) Displays the failure code for assay calibrations with the Failed status. For a
list and explanation of failure codes, see Section 5.5: Troubleshooting Failed
Calibrations.
Cal Lot (Field) Displays the lot number of the calibrator used to calibrate the assay.
Figure 5-12 Calibration Data Screen Descriptions (continued)

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Data Table (Table) Displays a list of the calibrator samples run, the results specific to each test,
and the mean result information for test replicates.
NOTE
For some qualitative assays, three replicates are run and the results of one
replicate may be excluded when determining whether the calibration passes or
fails.
Stated Conc.
- For curves, the concentration of analyte material in the calibrator level, as

stated on the calibrator card.
- For cutoffs, the target interpretation for the calibrator tested.
• RLU - The number of relative light units (RLUs) measured for each test replicate
or the calculated mean of the RLUs of the replicates.
• 1 SD - One standard deviation of the RLUs.
• %CV - The percent coefficient of variation for the test replicates.
• Calculated Conc. - For curves only, the analyte concentration measured and
calculated by the system for each replicate and for the mean of the replicates.
Values larger than ten digits are displayed in e-format.
• Result - For cutoffs only, the interpretation of the calibrator test result as
reactive or non-reactive, based on the cutoff. For confirmatory assays only, the
interpretation of the calibrator test result as confirmed or not confirmed. For
more information about types of assays, see Section 1.4: Assay Calibration
Theory in the Reference Manual.
• Flags - The names of up to two test result flags if flags are associated with the
result.
Curve (Log) or (Chart) Displays the curve generated from the calculated RLU means for this
Curve (Linear) calibration.
(for curves only) • Point cursor - A blue, vertical line that indicates the point selected in the data
table.
• RLUs (y-axis) - The range of mean RLU readings for this calibration.
• Concentration (x-axis) - The range of stated calibrator concentrations. The
x-axis may be plotted on a logarithmic (log) or linear scale.
• Points - The graphic representation of the calibration results. Each result is
plotted where the RLU value (y-axis) meets the calculated concentration
(x-axis).
Arrow Buttons (Buttons) Select to move the point cursor on the curve to the next data point in the
(for curves only) direction of the arrow. The next data point is selected in the data table.

C73199-AA
Acceptance Limits (Table) Displays the upper and lower RLU measurement limits defined in the APF
(RLUs) for each calibrator level of this assay. RLU readings beyond these limits result in
(for cutoffs only) failed calibrations.
• Level - The calibrator level.
• Replicate Low - The lowest acceptable RLU reading for a test replicate.
• Replicate High - The highest acceptable RLU reading for a test replicate.
• Mean Low - The lowest acceptable calculated RLU mean.
• Mean High - The highest acceptable calculated RLU mean.
Select Curve (Button) Select to display a menu of the most recent calibrations for this reagent
F1 lot.
Active F1
or Displays the active calibration for the assay.
Previous Active F2
Select Limits
F1 Available for curves only. Displays the previous active calibration for the assay.
Last Run F3
Displays the last run calibration.

For more information, see The Most Recent Calibration Data topic.
Switch Active (Button) Select to switch the active calibration for the assay with the previous
Curve active calibration. For more information, see the Switching the Active with the
F2 Previous Active Calibration procedure.
(for curves only)
Comment (Button) Select to display the Calibration Comment window, where you can enter,
F3 view, or edit a comment about the calibration. For more information, see the
Entering, Viewing, or Editing a Calibration Comment procedure.
Print (Button) Select to print the Calibration Data Report for the displayed calibration.
F7 For more information, see the Printing a Calibration Data Report procedure.

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Viewing Use this procedure to view detailed calibration data, along with the generated
Calibration calibration curve or cutoff.
Data
NOTE
For some qualitative assays, three replicates are run and the results of one
replicate may be excluded when determining whether the calibration passes or
fails.

1. From the Calibration screen, select the Assay button for the assay calibration and
reagent lot you intend to view.
2. Select Review Data F2 to display the Calibration Data screen.
 (Optional) To display another recent calibration, select Select Curve F1 or

Select Limits F1, then select one of the available calibrations from the menu.
• Active F1 - Displays the active calibration for the assay.
• Previous Active F2 - Available for curves only. Displays the previous active
calibration for the assay.
• Last Run F3 - Displays the last run calibration.
For more information about active, previous active, and last run calibrations, see The
Most Recent Calibration Data topic.
Switching the For quantitative and semi-quantitative assays only, use this procedure to switch the
Active with active calibration with the previous active calibration. For more information on active
the Previous and previous active calibrations, see The Most Recent Calibration Data topic.
Active NOTE
Calibration
This procedure will not change calibration expiration dates or recalculate results
for patient samples that have already been run.

1. From the Calibration screen, select the Assay button for the assay calibration you
intend to switch.
3. Select Switch Active Curve F2.
4. Confirm your selection and then select OK F1 to switch the active with the
previous active calibration.

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Entering, Use this procedure to enter, view, or edit a calibration comment. Comments print on
Viewing, or the Calibration Data Report.
Editing a System Mode: Any Mode
Calibration 1. From the Calibration screen, select the Assay button for the assay calibration you
Comment intend to comment on.
3. Select Comment F3 to display the Calibration Comment window.
4. Enter, view, or edit a comment for the calibration.
 (Optional) To delete a comment, select all of the text in the Calibration Comment
window and press [Delete].
5. Select OK F1 to save your comments or changes.
Printing a Use this procedure to print the information from the Calibration Data screen
Calibration manually. You can also set the Calibration Data Report to print automatically after a
Data Report calibration is run. For more information about report setup, see Section 2.2: System
1. On the Calibration screen, locate the Assay button for the calibration data you
intend to print. If needed, apply a different filter. For more information, see the
see the Applying a Calibration Filter topic in Section 5.1: Assay Calibration
Overview.
2. Select the Assay button, then select Review Data F2.
3. From the Calibration Data screen, select Print F7.

A print message is displayed and then the report prints.

C73199-AA
Laboratories, Inc.
Laboratory A
Calibration Data Report 123 Lake Street
tUniCel DxI 800, Access Immunoassay System Townsville, ST 33333
S/N 610240 101-555-2323 ext. 109 Jane Smith
Test Name: Ferritin Calibration: Active

Reagent Lot: 000125 Status: Passed
Calibrated: 03/03/10 11:05 AM Reason:
Expiration: 03/31/10 11:05 AM Cal Lot: 1 25002
Comment:
Stated Conc. ng/mL RLU 1SD %CV Calculated Conc. ng/mL Flags
S0 0.0 11238 0.0
S0 0.0 10730 No Value
Mean 10984.0 359.2 3.3 0.0
S1 10.0 129201 10.3
S1 10.0 127697 10.2
Mean 128449.0 1063.5 0.8 10.3
S2 50.0 586338 49.3
S2 50.0 597980 50.3
Mean 592159.0 8232.1 1.4 49.8
S3 200.0 2202860 197.6
S3 200.0 2239570 201.2
Mean 2221215.0 25957.9 1.2 199.4
S4 500.0 4795090 495.6
S4 500.0 4869380 505.6
Mean 4832235.0 52531.0 1.1 500.6
S5 1500.0 9894830 1535.7
S5 1500.0 9660040 1464.2
Mean 9777435.0 166021.6 1.7 1500.0
Page 1 of 1
Technologist ______________________________________________ Printed 03/03/10 11:05 AM
2132B.bmp
Figure 5-13 Calibration Data Report (Curve) Example

C73199-AA
UniCel DxI Operator's Guide 5.5: Troubleshooting Failed Calibrations
5.5 Troubleshooting Failed Calibrations
Assay calibrations can fail for various reasons. To rule out and fix the most significant
problems first, troubleshoot each failure in the following order:
1. Troubleshoot event log errors. For more information, see Section 5.3:
Troubleshooting Caution and Warning Events in the Reference Manual.
Test Results.
3. Run all System Check routines. If results are out of range, contact Technical
Support. For more information, see Section 4.4: System Check Routines in the
Reference Manual.
4. Troubleshoot according to calibration failure codes and assay calibration
troubleshooting tables.
If you are unable to identify the cause of a calibration-related problem, or if the

problem persists after you troubleshoot, contact Technical Support for assistance.

C73199-AA
5.5: Troubleshooting Failed Calibrations UniCel DxI Operator's Guide
Calibration When a calibration fails, the system displays a failure code in the Reason field on the
Failure Codes Calibration Data screen and the Calibration Data Report.
Failure Code Description
Bad Fit The curve does not meet the acceptance criteria defined in the
APF. Possible causes are poor precision or a curve that is too
flat or too steep.
CV Std 0 The %CV of the S0 (zero) calibrator replicates does not meet
the acceptance criteria defined by the APF.
Insuff Data The system did not have enough data to perform the
necessary calibration calculations. This failure occurs when
two or more replicates are not calculated, usually due to a
short sample or an instrument error.
Limits The RLUs of either a replicate or the mean of the replicates
are outside the accepted ranges defined in the APF.
Max Iterate The system was unable to create a curve before performing
the maximum number of calculation iterations. The system
attempts to calculate the curve 100 times before it generates
this error.
No Fit The system was unable to fit a curve to the data points.
Possible causes include math rule violations, such as dividing
by zero or calculating the log of a negative number.
Resp Delta The total response of the curve, which is the difference
between the highest RLU reading and the lowest RLU
reading, is too small.
Temp. Out The upper cabinet temperature changed more than 6ºC while
the system processed the curve replicates.
Table 5-14 Calibration Failure Codes

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Assay When a calibration fails, look for and troubleshoot system errors. For more
Calibration information, see the introduction to this section (see Section 5.5: Troubleshooting
Problems Failed Calibrations).
After ruling out or resolving system errors, use the following table to help
troubleshoot remaining calibration problems.
Symptoms Possible Causes Corrective Action
Although precision Multi-level calibrators aliquoted out of 1. Place the calibrators in the rack in the order
is good, the order, resulting in: displayed on the Test Requests screen (see
calibration fails for • A calibration curve that does not ascend Section 5.3).
any reason other or descend smoothly 2. Repeat the calibration.
than Insuff Data
• A calibration cutoff that is opposite of
the expected result
Expired calibrator lot (CLX result flag) 1. Find the expired calibrator lot on the Calibrator
Setup screen (see Section 5.2).
2. Delete the calibrator lot, discard all calibrator sets
of this expired lot, and set up a new, unexpired
calibrator lot.
3. Repeat the calibration using the same reagent lot,
if available.
Calibrator set beyond its stability date 1. Compare the date of thaw or the date of expiration
recorded on the calibrator vials to the product
stability information provided in the reagent
instructions for use.
2. If the calibrator vial is beyond its stability date,
discard the calibrator.
3. Repeat the calibration using the same calibrator
lot and reagent lot, if available.
Calibrator unstable or contaminated due to Repeat the calibration. If possible, repeat with a new
improper storage or handling set of the same calibrator lot.
Reagent pack unstable or contaminated 1. Unload the reagent pack and load a new reagent
due to improper storage or handling pack (see Section 2.7).
2. Repeat the calibration.
Incorrect calibration information entered 1. Confirm the calibrator information on the

during calibrator setup Calibrator Setup screen (see Section 5.2).
• If the information is incorrect, edit the
information.
• If you cannot edit the incorrect information,
delete and set up the calibrator again.
Table 5-15 Failed Assay Calibration Troubleshooting Table

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Although precision A rack of patient samples was processed 1. Unload the racks (see Section 3.4) and look for
is good, the as a rack of calibrators because the racks duplicate rack IDs.
calibration fails for had the same rack ID (when processing 2. If a patient sample rack has the same rack ID as
any reason other LIS requests with host query) the calibration request, process the patient samples
than Insuff Data again (see Section 3.2), making sure that:
(continued)
• Adequate sample is in the container for
processing (see Section A.2).
• The rack has a unique rack ID.
3. Request the calibration again, making sure that
each rack has adequate sample for processing and
that calibrators are loaded in racks with unique
rack IDs.
Contaminated substrate supply Contact Technical Support. Decontaminate the

substrate (see Section 6.4 in the Reference Manual)
only if instructed to do so by Technical Support.
Although precision Wrong calibrator placed in rack 1. Place the correct calibrators in the rack.
is good, the 2. Repeat the calibration.
quantitative curve
is flat or the
qualitative result is
No Value;
calibration fails for
any reason other
than Insuff Data
Routine maintenance not performed 1. Perform routine maintenance (see Section 7.1).
Poor precision, Problems with the pipettor, substrate, or 1. If the results of all System Check routines are
and calibration RV wash system within the expected ranges, these systems are not
fails for any reason the cause of the calibration failure.
other than Insuff
Data 2. If the results of any of the System Check routines
are not within the expected range, contact
Technical Support for assistance in
troubleshooting.
Reagent gone because it leaked out of the 1. Unload the reagent pack and load a new reagent
pack during off-board storage or a partial pack (see Section 2.7).
pack from another Access Immunoassay 2. Repeat the calibration.
System was loaded on the UniCel DxI
system
RLUs are too low Some reagent loss during off-board Repeat the calibration with the open reagent pack.
at one end of the storage (first few test replicates between Note:
calibration curve, 6,000-9,000 RLU, remaining replicates During processing, the instrument attempted to aliquot
and calibration acceptable) the lost reagent from the reagent pack and aspirated air
fails for any reason for the first few test replicates, resulting in low RLUs.
other than Insuff Once the pipettor reached the actual level of reagent in
Data the pack, the RLUs returned to acceptable levels.
Table 5-15 Failed Assay Calibration Troubleshooting Table (continued)

C73199-AA
Calibration fails Quantity of calibrator not sufficient for 1. Calculate the correct volume of calibrator needed
for the reason testing (QNS result flag and event) for the number of replicates and type of sample
Insuff Data container used (see Section A.2 for the equation).
2. Pipette the amount of calibrator calculated in
step 1 into the appropriate sample container.
3. Be sure the rack and rack ID are correct (see
5. If the calibration fails again for the same reason,
contact Technical Support for assistance.
Two or more replicates not calculated due 1. Review the Event Log messages (see Section 5.2
to instrument error in the Reference Manual) for device errors prior to
the calibration failure.
2. Review the Test Results screen for flags (see
Section 4.3).
3. Troubleshoot the device errors. If necessary,
4. After resolving the device errors, repeat the
calibration.
Calibrator sample missing from required 1. Place the sample containers in the rack in the
position order displayed on the Test Requests screen (see
Section 5.3).
Table 5-15 Failed Assay Calibration Troubleshooting Table (continued)

C73199-AA

C73199-AA
UniCel DxI Operator's Guide 6: Quality Control
6 Quality Control
6.1 Quality Control Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Quality Control Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Applying a Quality Control Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7
Westgard QC Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
QC Status Indicators and Flags . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
Printing the QC Review Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
6.2 Setting Up Quality Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-11
QC Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-12
Adding or Editing a Quality Control Lot . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13
Designating Reagent Pipettors for a Quality Control . . . . . . . . . . . . . . . . . . 6-17
Deleting a Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19
6.3 Running Quality Control Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-20
Entering QC Test Requests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-21
Editing QC Test Requests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-26
Assigning a Reagent Lot for QC Test Requests . . . . . . . . . . . . . . . . . . . . . . 6-27

C73199-AA
6: Quality Control UniCel DxI Operator's Guide
6.4 Reviewing Quality Control Charts and Data . . . . . . . . . . . . . . . . . 6-28
QC Chart and Data Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-29
Levey-Jennings Charts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-33
Applying a QC Chart and Data Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-34
Viewing QC Charts and Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-35
Entering Quality Control Comments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-36
Omitting a QC Data Point . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37
Deleting a QC Data Point. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37
Printing a QC Chart or Data Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-38
Copying QC Data to a Disk or Flash Drive . . . . . . . . . . . . . . . . . . . . . . . . . . 6-42
6.5 QC Chart Comparisons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-44
Compare Charts Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-45
Comparing QC Charts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-46
Changing the Date Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-48
Saving QC Comparisons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-49
Deleting QC Comparisons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-49
6.6 Establishing QC Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-50
Collecting Data to Establish QC Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-50
Evaluating QC Data and Establishing Ranges . . . . . . . . . . . . . . . . . . . . . . . . 6-51
6.7 QC Troubleshooting Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-53
Troubleshooting QC Problems. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-53
Rerunning a QC Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-55

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UniCel DxI Operator's Guide 6.1: Quality Control Overview
6.1 Quality Control Overview
Quality controls are samples of known concentration that are used to monitor system
performance and verify calibration. Quality control (QC) samples can be run
separately, or in a rack with patient samples.
Handle QC samples as recommended in the QC directional insert. The

Access Immunoassay System reagent instructions for use specifies how often the QC
should be run. Also run QC for all assays you use to analyze patient samples:
• After test interval maintenance or unscheduled maintenance
• After successfully installing new software
Evaluate out-of-range QC results. For information on troubleshooting QC problems,

see Section 6.7: QC Troubleshooting Overview.
Quality control operations for the UniCel DxI Access Immunoassay System can be
grouped into four main processes (see Figure 6-1):
• Setting up quality controls, in which you provide information about the QC
samples, including expected ranges of results, rules for flagging results that
are outside of the expected ranges, and pipettors to use for QC tests
• Running QC tests
• Reviewing the results, comparing results from different QC test runs, printing
QC reports, and so on
• Troubleshooting out-of-range QC results
When the system flags a result because of a violation of an applied QC rule, the
Quality Control button turns red until it is selected. For information about reviewing
test results and flags, see Chapter 4: Test Results. For help on how to interpret failed
quality controls, see Section 6.7: QC Troubleshooting Overview.

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6.1: Quality Control Overview UniCel DxI Operator's Guide
Set up Quality Controls by lot

number
Periodically run QC tests
Did tests produce

No Troubleshoot failed QC and
correct problem as indicated
results?
Yes
Review QC charts and data

or compare charts
Troubleshoot out-of-range
Are all results in No QC, correct problem, or
range? adjust QC ranges, as
indicated
Yes
Report patient sample

results
2048B.wmf
Figure 6-1 Quality Control Flowchart

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Quality Use the Quality Control screen to:

Control • Set up quality controls
Screen • View the chart and data for a selected quality control, or compare the charts
for two or three quality controls
• Print the QC Review Report
2062B.bmp
Filter (Field) Displays the current filter and sort parameters.

Entries (Field) Displays the combined number of quality controls and comparisons that
meet the current filter parameters.
Comparison (Buttons) Select a Comparison button to view a saved comparison.
Buttons A Comparison button is displayed when you save a comparison of two or three
quality controls. Comparison buttons are labeled with the word, Comparison, and a
two-line description that you enter when you save the comparison.
Comparison buttons are always displayed first on the Quality Control screen.
Comparison buttons cannot be selected if any QC buttons are selected.
Figure 6-2 Quality Control Screen Descriptions

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QC Buttons (Buttons) Select to view the chart and data for a particular quality control, or to
compare charts for two or three quality controls.
One button is displayed for each assay that has been run successfully at least once
on a specific quality control lot. QC buttons are labeled with the QC name, lot
number, and test name.
QC buttons turn red to indicate out-of-range results. Select a red QC button to view
the results. Once selected, the QC button returns to neutral.
No QC buttons can be selected if a Comparison button is selected.
Filter (Button) Select to change the filter and sort order parameters for quality controls.
F1 Comparison buttons are always displayed before QC buttons.
Review Chart and (Button) Select to view the accumulated data for the selected QC button. This
Data button is not available if more than one QC button is selected, or if a Comparison
F2 button is selected.
Compare Charts (Button) Select to view the charts for two or three quality controls. This button is
F3 available only when two or three QC buttons are selected, or when a Comparison
button is selected.
Delete Comparison (Button) Select to delete one or more saved comparisons.
F4
QC Setup (Button) Select to display the QC Setup screen to add, edit, or delete quality
F5 controls.
Print (Button) Select to print a report of the quality controls that are currently set up. For
F7 more information, see the Printing the QC Review Report topic.
Figure 6-2 Quality Control Screen Descriptions (continued)

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Applying A quality control filter is a set of parameters you can change to reduce or expand the
a Quality number of quality controls displayed on the Quality Control screen.
Control Filter Use this procedure to apply a different filter or sort order to the Quality Control
screen.

1. From the Quality Control screen, select Filter F1 to display the Filter window.
0758A.bmp
Filter (List) Select a filter to apply to the Quality Control

screen.
Instruments (List) Displays the system ID of the instrument.
Sort Order (Option) Select a first and second sort order.
Ascending (Box) Select to sort the quality controls in ascending
order. Clear the box to sort the quality controls in
descending order.
Description (Field) Displays a description of the selected filter.
Figure 6-3 Filter (Quality Control) Window Descriptions
2. Select a filter from the list.
 (Optional) Select the first and second sort order you want to apply.

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 (Optional) To sort the quality controls and comparisons in ascending

alphanumeric order, select the Ascending box. To sort the quality controls and
comparisons in descending alphanumeric order, clear the Ascending box.
3. Select OK F1.
The Quality Control screen displays all quality controls that meet the selected
parameters.
NOTE
Comparison buttons are always displayed, and always precede QC buttons.
Comparison buttons are always sorted alphanumerically by comparison name, in
ascending or descending order, as determined by the setting of the first sort order
Ascending box.
Westgard QC Westgard QC rules are interpretive rules developed to avoid excessive false rejection
Rules rates, to improve quality monitoring, and to decrease subjectivity of data analysis.
Each laboratory determines the QC rules to apply and the course of action to take
when a result violates a rule. Understand how your laboratory uses QC rules before
you set up controls.
Application of a QC rule consists of screening quality control test results for the
number of standard deviations (SD) above or below the mean, and for the number of
consecutive occurrences. Data points are colored red to mark violations of rules. For
each combination of control lot and reagent, you can apply one or more of these QC
rules:
• 12s (1-2s) — The system marks a data point if it is more than 2 SD from the
mean.
• 22s (2-2s) — The system marks a data point if two consecutive points of a
given quality control are more than 2 SD from the mean in the same
direction. The system only marks the second point.
• 13s (1-3s) — The system marks a data point if it is more than 3 SD from the
mean.
• 41s (4-1s) — The system marks a data point if four consecutive points of a
given quality control are more than 1 SD from the mean in the same
direction. The system only marks the fourth point.
• 10x (10x) — The system marks a data point if ten consecutive points of a
given quality control are on the same side of the mean (for example, ten
points are above the mean). The system only marks the tenth point.

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QC Status In addition to being provided on screens that are specific to quality controls, QC status
Indicators and information is provided in a number of other places.
Flags Quality Control Button
The Quality Control system status button appears in the row of system status buttons
at the top of every screen, and turns red when a QC test produces results that violate
one or more Westgard QC rules. Select the Quality Control button to go directly to
the Quality Control screen from any screen. If the Quality Control button is red, it
returns to neutral when selected.
2010A.bmp
Figure 6-4 Quality Control System Status Button
QC Buttons
The QC buttons on the Quality Control screen turn red when a test produces results
that violate one or more Westgard QC rules. Select the button to view the chart and
data for that QC. Once selected, a red QC button returns to neutral.
Test Result Flags

Two non-fatal test result flags are associated with quality control tests, and are
displayed in the Flags column of the Test Results screen:
QCF Indicates that the QC test violated one or more Westgard QC rules
QEX Indicates that the QC lot has expired

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Printing the Use this procedure to print the QC Review Report. This report lists all of the quality
QC Review controls in the current filter of the Quality Control screen. To print the report, select
Print F7.
Report
Laboratories, Inc.
Laboratory A
QC Review Report 123 Lake Street
tUniCel DxI 800, Access Immunoassay System Townsville, ST 33333
S/N 610240 101-555-2323 ext. 109 Jane Smith
Filter: All Controls - Sorted by Test Name and Control Name
Control Name Control Lot Test Name Expiration Instrument Designated

Pipettors
CardiacA 1234567A CK-MB 12/10/03 654321 3,4
CardiacB 1234567B CK-MB 12/10/03 654321 1,3
CardiacC 1234567C CK-MB 12/10/03 654321 2
CardiacA 1234567A Dig 12/10/03 654321 1,2,3,4
CardiacB 1234567B Dig 12/10/03 654321 1
CardiacC 1234567C Dig 12/10/03 654321 3
HighControl 98765C freePSA 12/10/03 654321 N/A
LowControl 98765A freePSA 12/10/03 654321 N/A
CardiacA 1234567A MYO 12/10/03 654321 3
CardiacB 1234567B MYO 12/10/03 654321 3,4
CardiacC 1234567C MYO 12/10/03 654321 1,3
HighControl 98765C PSA-Hyb 12/10/03 654321 2
LowControl 98765A PSA-Hyb 12/10/03 654321 1,2,3,4
Page 1 of 1
Technologist ____________________________________________ Printed 10/10/03 02:43 PM
2081B.bmp
Figure 6-5 QC Review Report Example

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UniCel DxI Operator's Guide 6.2: Setting Up Quality Controls
6.2 Setting Up Quality Controls
Each new lot of a quality control must be set up before it can be selected in a QC test
request.
To set up a quality control lot, enter the name of the control, the lot number, the
expiration date, and the sample type, then select which assays can be run with this
control lot. For each assay, provide the expected mean and standard deviation for
results, and choose one or more Westgard QC rules for flagging out-of-range results.
A quality control lot can be configured for up to 50 assays.
To set up QC for onboard dilution tests, use QC samples with high concentrations of
analyte. Onboard dilution tests have a lowest reportable result that is slightly less than
the highest calibrator for the assay. For more information about onboard dilution tests,
see the Onboard Dilutions topic in Section 1.3 of the Reference Manual.
Establish an acceptable range of values (mean and standard deviation) for quality
controls specific for each UniCel DxI instrument. For each new lot, use the
manufacturer's suggested ranges from the directional insert as a guideline for the
expected mean and standard deviation (SD), until you have processed enough quality
control samples to determine a mean and SD specific for the instrument you use. For
more information, see Section 6.6: Establishing QC Ranges.
Other QC setup functions include:

• Removing a quality control lot
• Adding or removing assays from a quality control lot
• Changing assay ranges for a quality control lot
• Setting or changing the Westgard rules for each assay in a quality control lot
• Designating reagent pipettors to be used for each assay in a quality control lot

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6.2: Setting Up Quality Controls UniCel DxI Operator's Guide
QC Setup Use this screen to:

Screen • View all of the quality controls that have been set up
• Add a quality control
• Edit an existing quality control
• Delete a quality control
2063B.bmp
Control (Column) Displays the name of the quality control.

Control Lot (Column) Displays the number of the quality control lot.
Expiration (Column) Displays the expiration date of the quality control lot.
Sample (Column) Displays the sample type.
Add Control (Button) Select to add a new quality control lot.
F1
Edit Control (Button) Select to edit the selected quality control.
F2
Figure 6-6 QC Setup Screen Descriptions

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Delete Control (Button) Select to permanently remove the selected quality control and all
F6 associated data points from the system.
NOTE
This function requires you to enter the system password.
Figure 6-6 QC Setup Screen Descriptions (continued)
Adding or Use this procedure to add a new quality control lot or to edit an existing quality
Editing a control lot.
Quality System Mode: Any Mode
Control Lot 1. From the Quality Control screen, select QC Setup F5 to display the QC Setup
screen.
2. Perform one of the following actions:

• To add a new quality control lot, select Add Control F1 to display the Add
Control window.
• To edit an existing quality control lot, select the quality control from the list,
then select Edit Control F2 to display the Edit Control window.
NOTE
The Add Control window is similar to the Edit Control window except that:
• You can view other quality controls and lot numbers from the Edit Control
window.
• You cannot enter the expiration date or the sample type from the Edit Control
window.

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2181B.bmp
Control (List or Field) Select a quality control to edit, or enter the name of a quality control
to add.
Lot Number (List or Field) Select the lot number of a quality control to edit, or enter the lot
number for a quality control you are adding. Lot numbers must be unique.
Expiration (Field) Displays the expiration date for the quality control. If you are adding a
quality control, enter the expiration date.
Sample Type (List or Field) Displays the sample type for the quality control. If you are adding a
quality control, select a sample type from the list.
Test Name (List) Select a test name from the list of tests enabled on the instrument. If a test
has been disabled, the Test Name field cannot be changed. Also, if the selected
control row for an assay has already been defined (that is, selections were made for
all available fields), the Test Name field cannot be changed.
For more information about enabling and disabling a test, see the Disabling a Test
topic in Section 3.3: Test Setup of the Reference Manual.
Mean (Field) Enter the expected mean for the test. If a test has been disabled, the Mean
field cannot be changed.
SD (Field) Enter the expected standard deviation for the test. If a test has been
disabled, the SD field cannot be changed.
Unit (Field) Displays the units of measure used for the test results, as defined for the
selected test and sample type.
Figure 6-7 Add Control and Edit Control Window Descriptions

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Westgard QC (Boxes) Select the rules to apply for the new control. If a test has been disabled, the
Rules Westgard QC Rules fields cannot be changed.
Your laboratory determines the Westgard QC rules to apply and the course of
action you need to take when a result violates a rule. Understand how your
laboratory uses QC rules before you add controls. For more information, see the
Westgard QC Rules topic in Section 6.1: Quality Control Overview.
Designated (Field) Displays the reagent pipettors designated to process the test. Each
Pipettors designated pipettor runs one replicate of each requested test. If a test has been
disabled, the designated pipettors fields cannot be changed.
Clear Row (Button) Select to clear the information from a selected row.
F3
Designate Pipettor (Button) Select to designate one or more reagent pipettors to use for the selected
F4 test. For more information, see the Designating Reagent Pipettors for a Quality
Control topic. If a test has been disabled, the Designate Pipettor F4 button is gray
and not available.
Figure 6-7 Add Control and Edit Control Window Descriptions (continued)
3. Enter or select the name of the quality control. The name is limited to
15 characters. Allowable characters are 0-9, A-Z, a-z, /, +, and -.
4. Enter or select the lot number for the quality control. Lot numbers must be unique
and are limited to 12 characters. Allowable characters are 0-9, A-Z, and a-z.
NOTE
Some multi-level quality controls have the same lot number for each level. To
make the lot number unique, add the level (such as 1, 2, or 3), or some other
designator, to the lot number.
5. If you are adding a new quality control lot, enter the expiration date for the
quality control.
The expiration date format must follow the date format selected on the System Setup
screen. For more information about the date format, see Section 2.2: System Setup in
6. If you are adding a new quality control lot, select a sample type from the Sample
Type list.
7. If you are adding a test to a new or existing quality control, select an assay from
the Test Name list.

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8. Enter the expected mean value for the selected assay.
NOTE
During the initial setup of a new quality control lot, use the ranges (mean and
standard deviation) suggested by the manufacturer in the directional insert, then
establish QC ranges for each instrument. For more information, see
Section 6.6: Establishing QC Ranges.
9. Enter the expected standard deviation (SD) for the selected assay.
 (Optional) To add or edit Westgard QC rules to apply to QC test results for the
selected assay, select or clear one or more boxes. For more information, see the
Westgard QC Rules topic in Section 6.1: Quality Control Overview.
 (Optional) To designate one or more reagent pipettors for the selected assay,
select Designate Pipettor F4. For more information, see the Designating
Reagent Pipettors for a Quality Control topic.
10. To add another assay to a multi-analyte quality control, select a blank row and
repeat the preceding steps, beginning with step 7.
11. To remove an assay from the quality control, select the row for that assay, then
select Clear Row F3.
 (Optional) To edit an additional quality control without leaving the Edit Control
window, select it with the Control or Lot Number list. You will be prompted to
save the current quality control if you have made any changes to it.
12. To save the changes and exit the window, select OK F1.
The system adds any new quality controls to the QC Setup screen.
 (Optional) To document your changes, press the Print Screen key on the
keyboard. The system prints the screen image in a report format including the
date and time.

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Designating Use this procedure to designate one or more reagent pipettors to be used for a QC test,
Reagent or to allow the test to randomly use any assigned pipettor.
Pipettors for a
NOTES
Quality
• When you designate pipettors to use for a QC test, the test runs once on each
Control
designated pipettor for each requested test and replicate.
• A pipettor can only be designated for a QC test if it has been assigned to that
assay on the Test Setup screen. For more information, see Section 3.3: Test
• To perform this procedure from the Add Control window, begin with step 4.

1. On the QC Setup screen, select a quality control to edit.
2. Select Edit Control F2 to display the Edit Control window.
3. Select the test for which you intend to designate a pipettor.
4. Select Designate Pipettor F4 to display the QC Pipettor window.
2224B.bmp
Currently (Fields) Displays a check mark under the number of each reagent pipettor that has
Assigned for been assigned to this assay. For more information, see Section 3.3: Test Setup in
[assay] the Reference Manual.
Figure 6-8 QC Pipettor Window Descriptions

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Designate (Option and Boxes) Select one or more assigned reagent pipettors to be used for the
Pipettors for this quality control. The quality control will be run with each designated pipettor.
Control Boxes are not available for pipettors that are not assigned to this assay.
Any Assigned (Option) Select to allow the system to use any assigned pipettor when the quality
Pipettor control is run.
Figure 6-8 QC Pipettor Window Descriptions (continued)
5. To designate one or more pipettors to be used each time this quality control test is
run, select the Designate Pipettors option, then select the boxes for pipettors to
use. Only pipettors that are assigned to this assay can be designated for a QC test.
NOTE
If a pipettor that is designated for a QC test is disabled or is no longer assigned to
the assay when the QC test is requested, the replicates for that pipettor will not
run. The Supplies Required button turns yellow until the pipettor is enabled and
assigned. For more information, see the Enabling and Disabling Reagent
Pipettors topic in Section 2.3: Supplies Setup in the Reference Manual. Also see
the Assigning Pipettors to Tests topic in Section 3.3: Test Setup in the Reference
Manual.
 (Optional) To use any assigned pipettor for the test, select the Any Assigned
Pipettor option.
6. Select Done F1 to save any changes and exit the window.
 (Optional) To document your changes, print the QC Review Report. For more
information, see the Printing the QC Review Report topic in Section 6.1: Quality
Control Overview.

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Deleting a Use this procedure to delete a quality control and all the data points associated with
Quality that quality control lot.
Control
NOTES
• Before deleting a quality control, you may want to print the data or copy it to
a disk or flash drive.
passwords, see Section 2.2: System Setup in the Reference Manual.

1. From the Quality Control screen, select QC Setup F5 to display the QC Setup
screen.
2. Select the quality control to delete from the list.
3. Select Delete Control F6.

The system removes the quality control from the QC Setup, removes any buttons
associated with it from the Quality Control screen, and removes all data associated
with it from the database.

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6.3: Running Quality Control Tests UniCel DxI Operator's Guide
6.3 Running Quality Control Tests
Run quality control (QC) tests on QC lots that are set up on the system. (For setup
information, see Section 6.2: Setting Up Quality Controls.) You can run QC tests
separately, or in a rack with patient samples.
To best simulate the characteristics of patient samples, use quality control samples
prepared from material similar to the patient samples being tested. For example, if
testing serum, use serum-based quality control samples.
QC test results are reported, with any test result flags, on the Test Results screen. (For
more information, see Chapter 4: Test Results.) QC test results are also stored in a QC
database, and can be reviewed collectively on the QC Chart and Data screen. For
more information, see Section 6.4: Reviewing Quality Control Charts and Data.
When a QC test result violates one or more Westgard QC rules, the Quality Control
status button turns red, and on the Quality Control screen, the button for that quality
control also turns red. On the QC Chart and Data screen, data points that violate
Westgard QC rules are displayed in red, and in the data table, the rules that were
violated are displayed in red, with asterisks on both sides. To troubleshoot a QC result
that violates Westgard QC rules, see Section 6.7: QC Troubleshooting Overview. For
more information on Westgard QC rules, see Section 6.1: Quality Control Overview.
When a QC test fails to produce results, nothing is added to the QC database, and one
or more fatal flags are displayed on the Test Results screen, indicating the nature of
the problem. To troubleshoot a failed QC test, see Section 6.7: QC Troubleshooting
Overview.

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UniCel DxI Operator's Guide 6.3: Running Quality Control Tests
Entering QC Use this procedure to enter a test request for a quality control sample or a multi-level
Test Requests set of samples.
NOTES
• You can only order tests that are defined for the selected control lot. For
information on setting up a quality control lot, see Adding or Editing a
Quality Control Lot.
• You can run tests on patient samples and QC samples in the same rack, even
if different tests are requested for each sample. For information on entering
patient test requests, see Section 3.3: Patient Test Requests.
1. From the Main Menu, select Sample Manager F1 to display the Sample Manager
screen.
2. Select New Request F3, then select Patient/QC Requests F1 to display the Test
Requests screen. For more information about this screen, see Section 3.3: Patient
Test Requests.
4. Select Request QC F5.
The Request QC window is displayed.
2047C.bmp
Control (Column) Select the quality controls you want to run.

Control Lot (Column) Displays the quality control lot numbers.
Figure 6-9 Request QC Window Descriptions

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Expiration (Column) Displays the expiration dates for the associated

control lots.
Figure 6-9 Request QC Window Descriptions (continued)
5. Select up to four quality controls, then select OK F1.

Each quality control selected is displayed in one available sample position on the Test
Request screen.
6. Select the first quality control that you requested in the previous step.
7. Select the appropriate Test buttons.

• If a test is not defined for a selected control lot, the Test button is gray and
not available. Only Test buttons for assays that are defined for that control lot
are available.
• If at least one test in a panel is defined for the selected control lot, the Test
panel button is enabled. Only the panel tests that are defined for the control
lot are requested, and a message that some panel tests could not be requested
is displayed once per session in the Test Requests screen.
• If you are using a multi-analyte quality control, you can select multiple tests
to run for each sample.
• To run multiple replicates of a test, select the test multiple times. A number in
parentheses indicates how many times the test will run for the selected
sample. For each replicate you request, the number is multiplied by the
number of designated pipettors for the quality control. For more information,
see the Designating Reagent Pipettors for a Quality Control topic in Section
6.2: Setting Up Quality Controls.
NOTE
If you cannot find a Test button, it might not be enabled. For information on
configuring and enabling tests, see Section 3.3: Test Setup in the Reference
Manual.

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2060C.bmp
Reagent (Column) Lists the reagents that will be used to run the selected tests. When you
select a reagent from the list, the associated test number is displayed in the Test
field.
Reagent Lot (Column) Displays the lot number that has been assigned for each reagent, for the
selected sample position. If no reagent lot has been assigned, nothing is displayed,
and the instrument will use any available lot. For more information, see the
Reagent Pack Usage topic in Section 1.2: Assay Technology of the Reference
Manual.
Test (Field) Displays the test number associated with the selected reagent.
Change Reag. Lot (Button) Select to display a list of on-board lots of the reagent selected in the
Reagent field. Select a reagent lot from the displayed list to assign a reagent lot to
use for the QC test.
Remove (Button) Select to remove one replicate of a test from a selected sample position. If
more than one test is assigned to that sample position, select the associated reagent
from the Reagent list, or enter the number of the test in the Test field.
Test Buttons (Buttons) Select to assign a test or test panel to the selected sample position. The
Test buttons that are displayed depend on the selected sample.
Select a test more than once to run replicates. Select multiple tests for multi-analyte
quality controls.
Figure 6-10 Reagent List and Test Buttons Descriptions
8. Repeat steps 6 and 7 for each quality control test requested in step 5.
 (Optional) Assign an on-board reagent lot to use for a particular sample. For more
information, see the Assigning a Reagent Lot for QC Test Requests procedure.
 (Optional) To remove a test or a replicate of a test:

a. Select the test from the Reagent list.
b. Select Remove to remove one replicate of the test.
c. Repeat step b to remove additional replicates of the test.
9. Complete the test request by selecting a different sample position, or by exiting
the Test Request screen.

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10. Place the QC samples in the rack entered in step 3, and load the rack on the
instrument. For information on placing sample containers in racks and loading
racks on the UniCel DxI instrument, see Section 3.4: Loading and Unloading
Racks.
NOTE
If you are placing the sample containers in a rack that is designated for reserve
volume, be sure that the sample containers contain enough sample to provide the
reserve volume. For more information, see the Calculating Minimum Sample
Volume procedure in Section A.2: Sample Containers.

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Sample Manager
New Request F3
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
2057B.wmf
Figure 6-11 Entering QC Test Requests Flowchart

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Editing QC Use this procedure to edit a QC test request that has been entered, but not yet run.
Test Requests
NOTE
You can edit QC test requests any time before the instrument reads the rack and
sample container bar codes, or while the sample status is Requested. For more
information about sample status, see Section 3.5: Monitoring Sample Progress.

1. From the Sample Manager screen, select Views F1, then Racks F1 to display the
Racks view.
2. Select the rack that contains the QC test request you want to edit.
3. Select Edit Request F3.
The Test Requests screen is displayed.
 (Optional) To change the rack ID, select the Rack button or Select Rack ID F1,
and enter the new rack ID.
 (Optional) To add a new QC sample:

a. Select Request QC F5 to display the Request QC window.
b. Select a quality control lot.
c. Select the appropriate Test buttons.
4. Select the sample position that you want to edit.
5. Perform one or more of the following optional steps:
 (Optional) To clear a sample position, select Delete Sample F2, which removes
the sample and all requested tests from the selected sample position.
 (Optional) To assign a different QC lot number, select the new lot number from
the Patient ID/Lot Number list.
NOTE
Only QC lots that have been set up on the instrument can be selected. For more
information, see Section 6.2: Setting Up Quality Controls.
 (Optional) To add a new test, or a replicate of an existing test, select the

appropriate Test button.
• If you are using a multi-analyte quality control, you can select multiple tests
to run for each sample.
• To run multiple replicates of a test, select the test multiple times. A number in
parentheses indicates how many times the test will be run for the selected
sample.

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 (Optional) To remove a test or a replicate of a test:

a. Select the test from the Reagent list.
b. Select Remove to remove one replicate of the test.
c. Repeat step b to remove additional replicates of the test.
 (Optional) Assign an on-board reagent lot to use for a particular sample. For more
information, see the Assigning a Reagent Lot for QC Test Requests procedure.
6. Complete the test request by selecting a different sample position, or by exiting

the Test Request screen.
Assigning a Use this procedure to assign an on-board reagent lot to use for a particular QC sample.
Reagent Lot
for QC Test
1. From the Test Requests screen, select the sample position for which you want to
Requests assign a reagent lot.
2. Select the reagent in the Reagent list.
3. Select Change Reagent Lot to display the Set Reagent Lot window.
4. Select the reagent lot to assign, or select Any to allow the instrument to use any
available lot, according to its reagent pack usage rules. For more information, see
the Reagent Pack Usage topic in Section 1.2: Assay Technology of the Reference
Manual.
The number of the selected lot is displayed in the Reagent Lot column. All replicates
of a test for a particular sample position will use the same reagent lot, but if the same
test is assigned to more than one sample position, each position can be assigned a
different reagent lot.
NOTE
You can only select reagents that are loaded on the instrument.
5. Select OK F1 to save the change and return to the Test Requests screen.

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6.4: Reviewing Quality Control Charts and Data UniCel DxI Operator's Guide
6.4 Reviewing Quality Control Charts and

Data
The UniCel DxI system keeps a QC database of all test results for each quality
control, and performs statistical calculations on the information stored in the database.
The statistical calculations for the selected quality control are performed on all data
points within the active date range, and are recalculated each time new results are
added, data points are omitted, or the active date range is changed.
The following statistical data is displayed on the QC Chart and Data screen:
• Date range used for calculations and data displays
• Calculated mean of the results
• Calculated standard deviation (SD) of the results
• Calculated coefficient of variation (%CV) of the results
• The number of points used in the calculations
QC result data is displayed numerically in a scrollable table that includes:

• The test result
• The deviation of the result from the expected mean
• The date and time of completion
• Applied Westgard QC rules and any violations of these rules
• Comments
• Whether a result has been omitted from calculations
• The reagent pipettor associated with the test result
QC results also are displayed graphically in Levey-Jennings charts to make it easier to

analyze data, to observe trends over time, and to see anomalous results.
QC data can be printed in report form, and can be saved to one or more diskettes for
use with a PC-based spreadsheet application for QC analysis.

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UniCel DxI Operator's Guide 6.4: Reviewing Quality Control Charts and Data
QC Chart and Use the QC Chart and Data screen to:

Data Screen • View QC data and charts
• Copy QC data to a disk or flash drive
• Print reports
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Test (Field) Displays the name of the test.

Control (Field) Displays the name of the quality control.
Control Lot (Field) Displays the lot number of the quality control.
Expiration (Field) Displays the expiration date of the quality control lot.
Instrument (Field) Displays the system ID of the instrument.
Pipettor (Field) Displays the numbers of the pipettors that are selected in the filter and
displayed on the chart and in the data table. Also see the Applying a QC Chart
and Data Filter topic.
Figure 6-12 QC Chart and Data Screen Descriptions

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Reagent Lot (Field) Displays the lot number of the reagent pack that is selected in the filter
and displayed on the chart and in the data table. For information about viewing
QC data for a specific reagent lot, see the Applying a QC Chart and Data Filter
topic.
Start (Field) Displays the first date of the date range included on the chart and table.
By default, date range is the past 31 days. For information about viewing QC
data for a specific date range, see the Applying a QC Chart and Data Filter topic.
End (Field) Displays the last date of the date range included on the chart and table. By
default, date range is the past 31 days. For information about viewing QC data
for a specific date range, see the Applying a QC Chart and Data Filter topic.
Mean (Field) Displays the calculated mean of the points within the date range. The
value displays with the number of decimal places defined for the assay, plus one
additional decimal place, up to a maximum of four decimal places.
Omitted points are not included in the calculations.
For information about defining the decimal places for an assay, see Section 3.3:
Test Setup in the Reference Manual.
SD (Field) Displays the calculated standard deviation (SD) for the points within the
date range. The value displays with the number of decimal places defined for the
assay, plus one additional decimal place, up to a maximum of four decimal
places. Omitted points are not included in the calculations.
%CV (Field) Displays the calculated coefficient of variation (%CV) of the points
within the date range. The value always displays with two decimal places.
Omitted points are not included in the calculations.
Points (Field) Displays the number of data points within the date range used to calculate
the mean, SD, and %CV. Omitted points are displayed on the chart with a slash
through them, but are not included in the calculations.
Point Cursor (Chart item) Displays as a blue vertical line on the graph, and marks the selected
point. Data for the selected point is displayed in the table beneath the chart. To
change the selected point, use the left and right Arrow buttons beneath the chart,
or select a point in the data table. Also see the Levey-Jennings Charts topic.
Calibration Line (Chart item) Displays as a dotted vertical line on the graph, and marks the first
result calculated after a change in calibration. Also see the Levey-Jennings
Charts topic.
Y-axis Left Scale (Chart item) Displays the seven y-axis coordinates expressed in result values.
These are the stated values for the mean and 1SD, 2SD and 3SD above and
below the mean. The value displays with the number of decimal places defined
for the assay, plus one additional decimal place, up to a maximum of four
decimal places. Also see the Levey-Jennings Charts topic.
Figure 6-12 QC Chart and Data Screen Descriptions (continued)

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Y-axis Right Scale (Chart item) Displays the seven y-axis coordinates expressed in standard
deviations. These mark the mean and 1SD, 2SD and 3SD above and below the
mean. Also see the Levey-Jennings Charts topic.
X-axis (Chart item) Displays the dates for the chart. Also see the Levey-Jennings Charts
topic.
Points (Chart item) Displays the plotted numerical value of the result. A slash through
the point indicates an omitted point. Points greater than 3 SD above the mean are
indicated as solid triangles on the +3 SD line, and points greater than 3 SD below
the mean are indicated as solid triangles on the -3 SD line. Points that are flagged
because they violate QC rules are displayed in red. Also see the Levey-Jennings
Charts topic.
Arrow Buttons (Buttons) Select to move the point cursor on the chart left or right to the next data
point, and to select the corresponding row of the data table. The chart and table
scroll as necessary to display the new selection.
Value (Column) Displays the test result and the unit of measure.
SDI (Column) Displays the deviation of the result from the expected mean, expressed
in standard deviation intervals, based on the standard deviation specified during
QC setup. The value always displays with one decimal place. For more
information, see Section 6.2: Setting Up Quality Controls.
Completion (Column) Displays the date and time of the result.
Westgard QC Rules (Column) Displays the five available Westgard QC rules. The rules applied to
this quality control are displayed in bold black characters. The rules violated by
this result are displayed in red, with asterisks on both sides.
Comment (Button) Select the button to read or enter a comment for a quality control result.
• Select the Pen button to enter a new comment.
• Select the Notepad button to read or edit a previous comment.
Omit (Box) Select to omit the result from QC calculations. The point remains on chart,
but has a slash through it.
Pipettor (Column) Displays the number of the reagent pipettor used for the QC test.
Filter (Button) Select to limit displayed data to certain reagent lots, date ranges, and
F1 reagent pipettors. For more information, see the Applying a QC Chart and Data
Filter topic.

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Delete Point (Button) Select to delete the currently selected point and all data associated with
F5 that point from the system. For more information, see the Deleting a QC Data
Point topic.
NOTE
You need a password to use this feature.
Copy to Disk (Button) Select to copy QC data. For more information, see the Copying QC
F6 Data to a Disk or Flash Drive procedure.
Print (Button) Select to print the QC chart and data for the currently selected quality
F7 control and date range. For more information, see the Printing a QC Chart or
Data Report topic.

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Levey- A Levey-Jennings chart is a graphical representation of quality control test results.

Jennings
The X-axis of the chart is the time scale, and displays date ranges of up to 31 days.
Charts For information about viewing a chart for a different range of dates, see the Applying
a QC Chart and Data Filter topic.
The Y-axis of the chart indicates test results and their deviation from the expected
mean. The Y-axis right scale is graduated in standard deviation intervals from +3 SD
to -3 SD, and the Y-axis left scale shows the corresponding test result values. The
Y-axis label values display with the number of decimal places defined for the assay,
plus one additional decimal place, up to a maximum of four decimal places.
Points that are above +3 SD are displayed as solid triangles on the +3 SD line. Points
that are below -3 SD are displayed as solid triangles on the -3 SD line.
Points that are flagged because they violate Westgard QC rules are displayed in red.
For more information, see the Westgard QC Rules topic in Section 6.1: Quality
Control Overview.
2059B.bmp
Figure 6-13 Levey-Jennings Chart
Use the Levey-Jennings chart to observe the range of quality control test results over a
period of time. QC results that are within an acceptable range form a normal
distribution pattern with equal numbers of points above and below the mean. A
normal distribution has approximately:
• 70% of the points between +1 SD and -1 SD
• 25% between +1 SD and +2 SD or between -1 SD and -2 SD
• 5% between +2 SD and +3 SD or between -2 SD and -3 SD
For information on identifying and correcting problems with QC results, see

Section 6.7: QC Troubleshooting Overview.

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Applying a QC Use a QC chart and data filter to control the amount of data displayed on the QC Chart
Chart and and Data screen and printed in reports. The filter limits data according to the
Data Filter following parameters:
• By date range - You can display data for the last week, the last month, or
you can specify a starting and ending date.
• By reagent lot - You can display data from a single reagent lot or all reagent
lots.
• By reagent pipettor - You can display data from any combination of the
available reagent pipettors.
Use the following procedure to apply a filter to the QC Chart and Data screen:

1. From the QC Chart and Data screen, select Filter F1 to display the QC chart and
data filter window.
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Date Range (Options) Select a date range. Options are:

• Last week (7 days)
• Last month (31 days)
• Specify (enter a start and end date)
Reagent Lot (List) Select all reagent lots, or a single lot from the list
View Specific (Boxes) Select any combination of the reagent pipettors
Pipettor
Figure 6-14 Filter (QC Chart & Data) Window Descriptions

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2. To change the date range, select from the following options:

• Last week - Display data from the last 7 days
• Last month - Display data from the last 31 days
• Specify - Enter a starting and ending date
NOTES
• When viewing charts for date ranges greater than 31 days, the last date
displayed on the chart will be the date of the most recent point in the date
range.
• When printing charts for date ranges greater than 31 days, the charts will
span multiple pages, with 31 days represented on each page, even if no data
exists for a particular 31-day period.
 (Optional) Select a single reagent lot to view, or select All to view data for all lots
of the reagent for the selected test.
 (Optional) Select one or more reagent pipettors to view only the data associated
with those pipettors.
3. Select OK F1 to save your changes and exit the window.
Viewing QC Use this procedure to view the QC data for a selected test.
Charts and System Mode: Any Mode
Data 1. From the Quality Control screen, locate and select the quality control you want to
view.
NOTE
To limit or reorganize the quality controls displayed on the Quality Control
screen, apply a filter. For more information, see the Applying a Quality Control
Filter topic in Section 6.1: Quality Control Overview.
2. Select Review Chart and Data F2. The QC data for the past 31 days is displayed
on the QC Chart and Data screen.
If no data is visible, or if the data points on the chart are too close together, adjust the
date range. For more information, see the Applying a QC Chart and Data Filter topic.
NOTE
Quality control tests may be completed while you are reviewing this screen. To
refresh the information displayed, exit the screen and display it again.
 (Optional) Apply a QC chart and data filter to display data for certain date ranges,
certain reagent lots, or certain reagent pipettors. For more information, see the
Applying a QC Chart and Data Filter topic.

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Entering Use this procedure to enter, edit, or delete comments for quality control test results on
Quality the QC Chart and Data screen.
Control System Mode: Any Mode
Comments 1. From the Quality Control screen, locate and select the quality control to
comment.
2. Select Review Chart and Data F2.
3. From the QC Chart and Data screen, select the Pen or Notepad button next to the
appropriate result to display the QC Comment window.
The pen indicates that no comments are associated with the result.
0727A.bmp
The notepad indicates that comments are associated with the result.
These comments were entered in the QC Comment window.
0728A.bmp
4. In the Comment field, enter or edit comments. To delete an existing comment,

select the text and press [Backspace].
5. Select OK F1 to save your changes and exit the window.

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Omitting a QC Use this procedure to omit a point from the QC calculations for the mean, SD, and
Data Point %CV. Omitted points continue to display on the screen and are included in reports.

1. From the Quality Control screen, locate and select the quality control that
contains the point you want to omit.
3. From the QC Chart and Data screen, locate the point to omit, and either select the
point on the chart or scroll to the data table entry for the point.
4. Select the Omit box for the point to be omitted.
The system removes the data point from the QC calculations. The point remains on
the chart, with a slash through it to mark it as omitted. Reports similarly reflect the
omitted status.
 (Optional) To restore an omitted data point to the QC calculations, clear the Omit
box.
NOTE
If a data point is omitted by the system due to a fatal flag or other error condition,
the omission is permanent and the Omit box cannot be cleared.
Deleting a QC Use this procedure to permanently delete a selected point from the screen, reports, and
Data Point QC calculations.
NOTE
You need the system password to use this feature. If you do not know the
password, contact your lab supervisor. For more information about passwords,
see Section 2.2: System Setup in the Reference Manual.

1. From the Quality Control screen, locate and select the quality control that
contains the point you want to delete.
3. From the QC Chart and Data screen, locate the point to delete, and either select
the point on the chart or scroll to the data table entry for the point.
4. Select Delete Point F5.

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Printing a QC Use this procedure to print a QC Chart Report, a QC Data Report, or both reports.
Chart or Data
Report
1. From the Quality Control screen, locate and select the quality control you want to
print.
 (Optional) Adjust the date range to include the points you want to print. For more
information, see the Applying a QC Chart and Data Filter topic.
NOTE
When printing charts for date ranges greater than 31 days, the charts will span
multiple pages, with 31 days represented on each page, even if no data exists for a
particular 31-day period.
3. Select Print F7 to display the Print window.
2090A.bmp
Report Type (Boxes) Select to print the chart, the data table, or both
reports. For an example of the data report format, see
Figure 6-16. For an example of the chart report format, see
Figure 6-17.
Figure 6-15 Print (QC Chart and Data) Window Descriptions

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Print Entire Date (Box) Select to print the entire date range selected in the
Range QC Chart and Data screen. If the date range is more than 31
days, charts continue on additional pages.
Clear to print only the data on the screen. Chart reports are
limited to 31 days, and data reports print only four lines.
Also see the Applying a QC Chart and Data Filter topic.
Figure 6-15 Print (QC Chart and Data) Window Descriptions (continued)
4. Select the QC report to print.
 (Optional) To print the entire date range selected in the QC Chart and Data
screen, select Print entire date range. For more information, see the Applying a
QC Chart and Data Filter topic.
NOTE
If you do not select Print entire date range, only the data visible on the screen is
printed:
• Chart reports consist of one page, with a maximum of 31 days.

• Data reports consist of the four lines displayed on the screen.
5. Select OK F1.
The system sends the report to the printer.

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Laboratories, Inc.
Laboratory A
123 Lake Street
QC Data Report Townsville, ST 33333
Test: PSA-Hyb Start Date: 10/01/10

Control: BRLevel2 End Date: 10/07/10
Control Lot: 1234567B Points: 8
Expiration: 12/31/12 Mean: 2.811
Stated Mean: 2.800 SD: 0.122
Stated SD: 0.200 %CV: 4.33
Des. Pipettor: 1,3,4 Units: ng/mL
Value SDI Completion QC Rules Comment Omit Reagent Pipettor

Lot
2.90 ng/mL 0.5 10/01/10 08:39 PM 130161 1
2.99 ng/mL 0.9 10/02/10 08:35 PM 130161 4
8.17 ng/mL 26.8 10/03/10 08:25 PM *1* *3* Contaminated X 130161 3
sample- retest
with new sample
2.71 ng/mL -0.5 10/03/10 09:10 PM 130161 3
2.83 ng/mL 0.2 10/04/10 08:37 PM 130161 1
2.66 ng/mL -0.7 10/05/10 08:52 PM 130161 4
2.82 ng/mL 0.1 10/06/10 03:12 PM 144219 1
2.23 ng/mL -2.9 10/07/10 04:18 PM *1* Sample left in X 144219 3
instrument too
long- retest
2.67 ng/mL -0.7 10/07/10 04:56 PM 144219 4
2.90 ng/mL 0.5 10/07/10 05:02 PM 144219 3
QC Rules: 1=1-2s, 2=2s, 3=1-3s, 4=4-1s, X=10x
Page 1 of 1
Technologist _____________________________________________ Printed 10/10/10 05:32 PM
2082B.bmp
Figure 6-16 QC Data Report Example

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Laboratories, Inc.
Laboratory A
123 Lake Street
C73199-AA
QC Chart Report Townsville, ST 33333
S/N 654321, Version 4.4 Jane Smith
________________________________________________________________________________________________________________________________
Test: PSA-Hyb Start Date: 06/23//10
Control: BRLevel2 End Date: 06/30/10
Control Lot: 1234567B Points: 8

Expiration: 12/31/12 Mean: 2.811
Reagent Lot All SD: 0.122
Stated Mean 2.800 %CV: 4.33
Stated SD: 0.200 Units: ng/mL
Des. Pipettor: 1,3,4
Figure 6-17 QC Chart Report Example

Page 1 of 1
Technologist ________________________________________________Printed 06/30/10 05:32 PM
6.4: Reviewing Quality Control Charts and Data
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6-41
Copying QC Use this procedure to copy QC data to a 3.5-inch high density, DOS-formatted disk or
Data to a Disk a USB flash drive. The system copies the QC data into a comma-separated field
or Flash Drive format that you can import to a PC-based spreadsheet application. The QC data fields
are:
• Control lot headers
• Control lot data
• Data point headers
• Rows of data point values

1. From the Quality Control screen, locate and select a quality control to copy.
2. Select Review Chart and Data F2 to display the QC Chart and Data screen.
 (Optional) Adjust the date range to include the points you want to save to disk.
For more information, see the Applying a QC Chart and Data Filter topic.
3. Insert the disk or flash drive into the PC.
• To copy data to a USB flash drive, insert a flash drive into a port on the front
of the PC. If the front of the PC does not contain a USB port, use a port on the
back of the PC.
NOTE
For UniCel DxI instruments set up to perform system backups using a USB flash
drive, the backup drive might already be in one of the USB ports on the back of
the PC. Use a different flash drive to copy data. Do not disturb the flash drive
used for backups when inserting and removing the flash drive for copying data.
• To copy data to a 3.5-inch disk, insert a disk into the 3.5-inch disk drive of
the PC.
4. Select Copy to Disk F6. A default file name and extension are provided in the
File Name field of the Copy to Disk window.
5. Confirm that the correct drive is selected from the Drive list, or select a different
drive.
NOTE
Unless directed by Technical Support, do not copy data to the C: Console_PC
drive or any drive labeled BACKUPDRIVE.

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 (Optional) To change the default file name, enter a file name and extension for
the data file in the File Name field.
• If you do not enter a file name or extension, the system supplies a file name
based on the date and time, with a .csv (comma delimited) extension.
• If the file name already exists on the disk or flash drive, the system displays a
warning message. Select Yes F1 to overwrite the existing file, or select
Cancel F8.
 (Optional) If the 3.5-inch disk is not formatted, select the Format disk box.
6. Select OK F1.
The copy process begins and a progress window is displayed.
7. If the disk or flash drive becomes full before the copy process is complete, the
system displays a status message.
• For a USB flash drive, clear sufficient space on the drive, or copy the files to
a different flash drive.
• For a 3.5-inch disk:
- Remove the disk and label it with the data file names.
- Insert another disk, and select OK F1.
The system automatically names the file on the new disk the same as the file on
the first disk, and adds a disk number to the end.
Example
If two disks are required to copy a test result file, and you name disk
one QCdata.csv, the system names disk two QCdata(2).csv.
8. When the copy process is complete, the progress window closes. Remove the disk
or flash drive from the PC and label it.
NOTE
If you will be using one disk or flash drive to copy multiple files, you can leave it
in place for the next copy operation. Be sure to keep track of the file names so you
can correctly label the disk or flash drive when you remove it.

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6.5: QC Chart Comparisons UniCel DxI Operator's Guide
6.5 QC Chart Comparisons
You can display charts for up to three QC test runs simultaneously in order to
compare the data. You can also save comparisons for later review. Saved comparisons
are updated with new data as QC tests are run.

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UniCel DxI Operator's Guide 6.5: QC Chart Comparisons
Compare Use this screen to:

Charts Screen • Compare the Levey-Jennings charts for two or three quality controls
• Save a comparison of the charts
2064B.bmp
Chart Name (Field) Displays the test name, quality control name, quality control lot number, and
system ID for data on the screen.
Date Range (Field) Displays the start and end dates for the chart data.
Mean (Field) Displays the calculated mean of the points within the date range. The value
displays with the number of decimal places defined for the assay, plus one additional
decimal place, up to a maximum of four decimal places.
Omitted points are not included in the calculations. For information about defining the
decimal places for an assay, see Section 3.3: Test Setup in the Reference Manual.
Figure 6-18 Compare Charts Screen Descriptions

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SD (Field) Displays the calculated standard deviation (SD) for the points within the date
range. The value displays with the number of decimal places defined for the assay,
plus one additional decimal place, up to a maximum of four decimal places. Omitted
points are not included in the calculations..
%CV (Field) Displays the calculated coefficient of variation (%CV) of the points within the
date range. The value always displays with two decimal places. Omitted points are not
included in the calculations..
Points (Field) Displays the number of data points within the date range used to calculate the
mean, SD, and %CV. Omitted points are displayed on the chart with a slash through
them, but are not included in the calculations.
Levey-Jennings (Chart) Displays a graph of the plotted points from each control. For more information
Charts about charts, see the QC Chart and Data Screen and Levey-Jennings Charts topics in
Section 6.4: Reviewing Quality Control Charts and Data.
Save (Button) Select to save the comparison. The system creates a Comparison button
Comparison F1 which can be selected to view the comparison.
Review Chart (Button) Select to display the QC Chart and Data screen for one of the charts. A menu
and Data F2 of chart numbers is displayed. Charts are numbered sequentially from the top.
Edit Date (Button) Select to change the range of dates for which QC data is displayed. For more
Range F4 information, see the Changing the Date Range topic.
Figure 6-18 Compare Charts Screen Descriptions (continued)
Comparing Use this procedure to view QC charts for two or three quality controls at the same
QC Charts time.
1. From the Quality Control screen, locate and select two or three quality controls
for comparison, or select a previously saved comparison to review.
To remove a button from your selection, select the button again.
NOTE
You can select a comparison button only if no quality controls are selected, and
you can select quality controls only if no comparison button is selected.
2. Select Compare Charts F3.

The Compare Charts screen is displayed, showing data generated within the last 31
days.

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 (Optional) To change the date range of the displayed data, select Edit Date
Range F4 and then enter the date range you want to view. For more information,
see the Changing the Date Range topic.
 (Optional) To save the comparison for viewing again, select Save
Comparison F1. For more information about how to save comparisons, see the
Saving QC Comparisons topic.
 (Optional) To view one of the charts in more detail, select Review Chart and
Data F2, then select the button (Chart-1 F1, Chart-2 F2, or Chart-3 F3)
corresponding to that chart. Chart-1 is the top chart in the display.
Quality Control
Select two or three quality

controls to compare
Compare Charts F3
Compare Charts
Save the No
comparison?
Yes
Is correct date Yes
range displayed?
Save Comparison F1
No Save Comparison
Edit Date Range F4 Enter text to name the

comparison
Edit Date Range
Change the date range Continue reviewing or

processing data
2103B.wmf
Figure 6-19 Comparing QC Charts Flowchart

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Changing the Use this procedure to change the date range used for QC chart comparisons.
Date Range
1. From the Compare Charts screen, select Edit Date Range F4 to display the Edit
Date Range window.
2094A.bmp
Options (Options) Select to set the date range:

• Select Last Week to limit data to the past seven days
• Select Last Month to limit data to the past 31 days
• Select Specify to enter any other date range
Start (Field) Enter the first date of the range you want to view.
End (Field) Enter the last date of the range you want to view.
Figure 6-20 Edit Date Range Window Descriptions
2. To set the date range to the past seven days, select the Last Week option.
3. To set the date range to the past 31 days, select the Last Month option.
4. To set any other date range:

a. Select the Specify option.
b. Enter the starting and ending dates in the Start and End fields.

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5. Select OK F1.
NOTE
When viewing charts for date ranges greater than 31 days, the last date displayed
on the chart will be the date of the most recent point in the date range.
Saving QC Use this procedure to save a comparison displayed in the Compare Charts screen.
Comparisons
1. From the Compare Charts screen, select Save Comparison F1.
2. Enter one or two lines of text for the Comparison button (notes or information
about the comparison) in the Line 1 and Line 2 fields of the Save Comparison
window.
3. Select OK F1 to save the comparison and create a Comparison button on the

Quality Control screen.
Deleting QC Use this procedure to delete a saved comparison. The Comparison button is removed
Comparisons from the Quality Control screen.

1. From the Quality Control screen, select Delete Comparison F4 to display the
Delete Comparison window.
2. Select one or more comparisons to delete.
3. Select OK F1.

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6.6: Establishing QC Ranges UniCel DxI Operator's Guide
6.6 Establishing QC Ranges
Your laboratory needs to establish a test-specific acceptable range of quality control

(QC) values for each UniCel DxI instrument. If your laboratory has not developed a
procedure to set these ranges, you can use the following procedures as a guideline.
As you set up quality controls for use on the instrument, record appropriate product
data and results.
NOTES
• Use fresh quality control materials for best results.
• Do not re-use quality controls by pooling them into sample containers or
storage containers.
Collecting Use this procedure over a 15-day period to gather sufficient data to establish quality
Data to control ranges for a specific UniCel DxI instrument.
Establish QC Required Materials
Ranges
• Access Immunoassay System assay calibrators (2 lots, if available)
• Access Immunoassay System reagent packs (2 lots, if available)
• Quality control materials, prepared according to the manufacturer's
instructions
Procedure
1. Calibrate the assay at the beginning of each 5-day period. Use different
combinations of calibrator and reagent lots, if available. For information about
running calibrations, see Chapter 5: Assay Calibration.

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UniCel DxI Operator's Guide 6.6: Establishing QC Ranges
2. Set up the quality controls, using the manufacturer's suggested mean and standard
deviation from the directional insert. For more information, see
Section 6.2: Setting Up Quality Controls.
NOTE
If you are using quality controls with no available suggested mean and standard
deviation values, use the values from a previous lot. If you are establishing ranges
for this quality control for the first time, assign reasonable values. The values
entered here will keep the data points from the first few tests within the visible
range of the chart. These values will be replaced by new values after more data
points are generated.
3. Run one or two replicates of each quality control test one time each day. For more
information, see Section 6.3: Running Quality Control Tests.
• Vary the sequence in which the QC samples are processed.
• Vary the reagent lots used to process the QC samples.
• After the second assay calibration, alternate between active and previous
active calibrations. For more information, see the Switching the Active with
the Previous Active Calibration topic in Section 5.4: Reviewing Calibration
Data.
• Continue processing QC samples for 15 days, until you have obtained a
minimum of 15 values per quality control level on at least three different
calibration curves (45 values minimum).
4. When you have collected the required amount of data, evaluate the data and set
the QC ranges. For more information, see the Evaluating QC Data and
Establishing Ranges topic.
Evaluating QC Use this procedure to evaluate accumulated QC data and establish acceptable ranges
Data and of values for each level of a tri-level quality control set on a specific UniCel DxI
Establishing instrument.
Ranges
NOTES
• This procedure requires a minimum of 15 test results per quality control
level. For more information, see the Collecting Data to Establish QC Ranges
topic.
• Depending on the values first used to establish the mean and the SD of the
quality control, many or all data points may appear to be out of range, and
may violate Westgard rules. This does not indicate a failure. After
performing the following steps, the data points should be evenly distributed
within acceptable range tolerances.

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6.6: Establishing QC Ranges UniCel DxI Operator's Guide
1. From the Quality Control screen, locate and select the quality control lot for
which you are establishing ranges, then select Review Chart and Data F2 to
display the QC Chart and Data screen.
2. Set the date range to the 15-day period during which the QC data was collected.
For more information, see the Applying a QC Chart and Data Filter topic in
Section 6.4: Reviewing Quality Control Charts and Data.
3. Write down the Mean and SD values displayed to the left of the Levey-Jennings
chart.
4. From the QC Chart and Data screen, select Back, then select QC Setup F5. Select
the quality control lot for which you are establishing ranges, then select Edit
Control F2 to display the Edit Control window.
5. Edit the quality control lot setup information, replacing the previous mean and
SD with the mean and SD from step 3. For more information, see the Adding or
Editing a Quality Control Lot topic in Section 6.2: Setting Up Quality Controls.
6. Return to the QC Chart and Data screen. The plotted points will now be evenly
distributed above and below the centerline on the Levey-Jennings chart.
7. Locate data points that are above +3 SD or below -3 SD (outliers). These points
are displayed on the chart as solid triangles on the +3 SD or the -3 SD lines.
NOTE
If no outliers are present, skip to step 10, using the current mean and SD values.
8. Remove outliers from the calculations by omitting any data points that are above
+3 SD or below -3 SD. For more information, see the Omitting a QC Data Point
topic in Section 6.4: Reviewing Quality Control Charts and Data.
As you omit outliers, the Mean and SD fields to the left of the Levey-Jennings chart
change to new values.
9. Perform a second outlier evaluation by repeating steps 3-8.
10. Return to the Edit QC window and edit the quality control lot setup information
with the mean and SD from the previous steps.
11. If the %CV is less than 6, multiply the SD by 1.5 and enter the result in the SD
field.
12. Record the mean and SD derived in the previous steps.
13. Periodically recalculate the mean and SD over the life of the quality control lot.

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UniCel DxI Operator's Guide 6.7: QC Troubleshooting Overview
6.7 QC Troubleshooting Overview
QC results can fail for a variety of reasons including past-due maintenance, cold
substrate, QC material stability, calibrator stability, reagent stability, and instrument
hardware or software problems.
Troubleshooting Use the following procedure to troubleshoot QC problems.

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. For more information, see Chapter 5: Event Log
Test Results.
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. For more information,
see Chapter 7: Routine Maintenance.
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 instructions for use.

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6.7: QC Troubleshooting Overview UniCel DxI Operator's Guide
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 1. Load the correct quality control.
the sample rack 2. Repeat the test.
Wrong quality control lot number Repeat the test using the correct lot number.
selected for the test
Wrong mean and/or standard 1. Review the QC information using Edit Control F2
deviation information entered when from the QC Setup screen.
setting up the quality controls 2. If necessary, edit the information (see Section 6.2).
3. Repeat the test.
Table 6-21 Troubleshooting Problems with QC Materials
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. For more information, see Section 4.4: System Check Routines in the
Reference Manual.
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. For more information, see the

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UniCel DxI Operator's Guide 6.7: QC Troubleshooting Overview
Assigning Pipettors to Tests topic in Section 3.3: Test Setup of the Reference
Manual.
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. For more
information, see the Enabling and Disabling Reagent Pipettors topic in
Section 2.3: Supplies Setup of the Reference Manual.
10. Recalibrate the assay to compensate for subtle changes in the instrument or
reagent. For more information, see Chapter 5: Assay Calibration.
11. If none of the preceding steps resolves the problem, contact Technical Support.
Rerunning a If a quality control test produces questionable results, use this procedure to rerun the
QC Test 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.
For more information on locating results, see the Finding a Test Result procedure in
Section 4.3: Reviewing Test Results or the Applying a Test Result Filter procedure in
NOTE
Only select a single result. If you select a group of results and then select
Rerun 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.

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6.7: QC Troubleshooting Overview UniCel DxI Operator's Guide
3. Go to the Sample Manager screen and select New Request F3, then select
Patient/QC Requests F1 to display the Test Requests screen.
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 Request screen.
8. Place the QC sample in the rack entered in step 4, and load the rack on the
instrument. For information on placing sample containers in racks and loading
racks on the UniCel DxI instrument, see Chapter 3: Sample Manager.
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.

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UniCel DxI Operator's Guide 7: Routine Maintenance
7 Routine Maintenance
7.1 Maintenance Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Maintenance Review Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
Requesting the Utility Routine Manually . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-6
Enabling and Disabling the Utility Routine. . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
Printing the Temperature Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
Requesting Maintenance Routines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
Maintenance Requests Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10
7.2 Daily Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-12
Backing Up the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-14
Recording the Test Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-14
Shaking Down the Solid Waste Container. . . . . . . . . . . . . . . . . . . . . . . . . . . 7-15
Running Clean Routines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-16
7.3 Special Weekly Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-19
7.4 Test Interval Maintenance: 5,000 Tests . . . . . . . . . . . . . . . . . . . . . 7-21
Replacing the Duck Bill Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-23
Verifying System Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-30

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7: Routine Maintenance UniCel DxI Operator's Guide
7.5 Test Interval Maintenance: 10,000 Tests . . . . . . . . . . . . . . . . . . . . 7-31
Installing Clean Aspirate Probes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-32
Cleaning the Aspirate Probes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-42
Removing and Inspecting the Dispense Probes . . . . . . . . . . . . . . . . . . . . . . . 7-45
Inspecting the Pump Connections at the Wash Buffer Reservoir . . . . . . . . . 7-49
Inspecting the Upper Aspirate Peristaltic Pump Connections . . . . . . . . . . . . 7-51
Inspecting the Reagent Pipettors and Cleaning the Wash Towers. . . . . . . . . 7-53
Inspecting for Fallen RVs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-56
Inspecting the Liquid Waste Drawer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-58
Inspecting the Wash Buffer Supply Drawer . . . . . . . . . . . . . . . . . . . . . . . . . 7-59
Cleaning the Air Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-60
7.6 Maintenance Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-62

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UniCel DxI Operator's Guide 7.1: Maintenance Overview
7.1 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. For more information, see
Section 7.2: 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. For more information, see Section 7.3: Special Weekly Maintenance.
Maintenance after a 5,000 test interval consists of a procedure for replacing the duck
bill valve. For more information, see Section 7.4: Test Interval Maintenance: 5,000
Tests.
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. For more information, see Section 7.5: Test Interval
Maintenance: 10,000 Tests.
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. For more information about enabling the Utility routine, see
the Enabling and Disabling the Utility Routine procedure.

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7.1: Maintenance Overview UniCel DxI Operator's Guide
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.
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
2270G.wmf
Figure 7-1 Routine Maintenance Overview Flowchart

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Maintenance Use the Maintenance Review screen to:

Review • Check or print the temperatures of the nine thermal zones
Screen • Display the System Checks screen
• Display the Carryover screen
• Decontaminate the substrate system
• Run, enable, or disable the Utility routine
2170D.bmp
Zone (Fields) Displays the current temperature reading in degrees Celsius for nine
Temperature (°C) thermal zones.
Temperature readings are updated in real-time. If a temperature reading is outside
of the range listed in the Limits (°C) field, the Temperature (°C) field for the
corresponding thermal zone turns red.
Limits (°C) (Fields) Displays the expected temperature range in degrees Celsius for each
thermal zone. If a temperature reading is outside of the range listed in the
Limits (°C) field, the Temperature (°C) field for the corresponding thermal zone
turns red.
Figure 7-2 Maintenance Review Screen Descriptions

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Pipettor (Button) Select to display the Pipettor Matching menu with the following options:
Matching F1 Reag. Pipettor Matching F1
Low Volume Matching F2
System Checks F2 (Button) Select to display the System Checks screen. For more information, see
Section 4.4: System Check Routines in the Reference Manual.
Carryover F3 (Button) Select to display the DxI Carryover screen. From the DxI Carryover
screen you can review and print the results of the DxI carryover test. For more
information, see Section 4.7: Carryover Testing in the Reference Manual.
Decontaminate (Button) Select to decontaminate the substrate system and any components that
Substrate F4 come in direct contact with the substrate. Use this function only as directed by
Technical Support. For more information, see Section 6.4: Fluidics Support
Procedures in the Reference Manual.
Run Utility (Button) Select to run the Utility routine manually. Run this routine only if
Routine F5 requested to do so by Technical Support, or if it is a required step in a
troubleshooting procedure. For more information, see the Requesting the Utility
Routine Manually procedure.
Disable (Button) Select to disable or enable the automatic Utility routine. If enabled, the
or Utility routine runs when the instrument has been idle for four hours. The button
Enable name switches between Disable Utility Routine and Enable Utility Routine each
Utility Routine F6 time you select it. For more information, see the Enabling and Disabling the Utility
Routine procedure.
Print F7 (Button) Select to print the Temperature Report. For more information, see the
Printing the Temperature Report procedure.
Figure 7-2 Maintenance Review Screen Descriptions (continued)
Requesting Use this procedure to manually request the Utility routine. Request the Utility routine
the Utility when instructed to do so by Technical Support, or when additional cleaning is
Routine required for troubleshooting. The Event Log prompts you to manually request a
Utility routine whenever processing is interrupted. The Utility routine takes
Manually
approximately three minutes to complete.
System Mode: Ready

1. From the Maintenance Review screen, select Run Utility Routine F5.

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2. Select Yes F1 to request the Utility routine.
NOTE
Do not load samples while the Utility routine is running.
Enabling and Enabling the Utility routine sets up the instrument to run the routine every four hours
Disabling the when it is not processing samples. The system records an event in the Event Log each
Utility Routine time you enable or disable the Utility routine.
Use this procedure to enable or disable the Utility routine on the Maintenance Review
screen.

1. From the Maintenance Review screen, enable or disable the Utility routine.
• To disable the Utility routine, select Disable Utility Routine F6.
• To enable the Utility routine, select Enable Utility Routine F6.
2. If you are enabling the Utility routine, and the routine has been disabled for more
than four hours, prime all of the fluidic components before continuing with
normal operation. For more information, see Section 4.3: Prime Fluidics in the
Reference Manual.
Printing the The Temperature report is a printout of the thermal zone temperatures displayed on
Temperature the Maintenance Review screen. To print a copy of the report, select Print F7 on the
Report Maintenance Review screen.
Requesting You can request and load maintenance routines while the system is processing
Maintenance samples. Requested routines run after calibrator, QC, and patient sample processing is
Routines complete.

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Use this procedure to request maintenance routines.
WARNING

1. From the Sample Manager screen, select New Request F3, then Maintenance F3
to display the Request Maintenance window.
2176B.bmp

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System (Options) Select one of the System Check routines.

Check • Washed - Checks the performance of the wash system.
Routines
• Unwashed - Checks the pipettor precision.
• Substrate - Checks the performance of the substrate dispense
system and luminometer.
• All - Select to run the complete System Check routine, which
includes the Washed, Unwashed, and Substrate routines. For
more information, see the Running System Check Routines
procedure in Section 4.4: System Check Routines of the
Reference Manual.
Clean (Options) Select one of the cleaning routines. For more
Routines information, see the Running Clean Routines procedure in
Section 7.2: Daily Maintenance.
• Daily Clean System - Cleans the interior of the reagent,
sample, and aspirate probes and primes the wash buffer lines.
• Special Clean - Cleans the reagent, sample, and aspirate
probes, and primes the wash buffer lines. The probes are
cleaned with ethanol to prevent the buildup of debris.
Other (Options) Select one of the three pipettor matching routines only
Routines if directed to do so by Technical Support.
For more information about the DxI Carryover routine, see
Section 4.7: Carryover Testing in the Reference Manual.
Figure 7-3 Request Maintenance Window Descriptions
2. Select a maintenance routine in the Request Maintenance window.
NOTES
• If you request a clean routine when one or more reagent pipettors are
disabled, the disabled pipettors will not be cleaned.
• Do not select the Run Matching, Verify Matching, or Low Volume
Matching routines unless you are directed to do so by a technical support
representative.
• Do not run patient, QC, or calibrator samples while System Check routines
are running. The Unwashed routine may fail. Wait until the System Check
routines are complete before loading patient, QC, or calibrator samples.
3. Select OK F1.
4. On the Maintenance Requests screen, enter the rack ID in the Enter ID field and
press [Enter].

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5. Prepare a rack as instructed on the Maintenance Requests screen, and place the
sample containers in the rack. For more information, see the Placing Sample
Containers in Racks procedure in Section 3.4: Loading and Unloading Racks.
6. Load the rack. For more information, see the Loading a Rack for Routine
Processing procedure in Section 3.4: Loading and Unloading Racks.
NOTE
If you load a rack with a System Check routine test request at the same time as a
rack with a clean routine request, the system runs the clean routine before the
System Check routine.
Maintenance Use the Maintenance Requests screen to:

Requests • View and verify the required position and contents of each sample container
Screen for the selected maintenance routine
• Enter or change the rack ID
2177B.bmp

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Rack Button (Button with field) Displays the rack ID, and the required position, contents, and
and volume of each container in the rack.
Enter ID Select the Rack button to enter or change the current rack ID. The Enter ID field is
displayed.
Contents (Column) Displays the name of the requested maintenance routine, and the
required contents and volume of each sample container in the rack.
Position (Indicator) Indicates the position of each sample container in the rack. The
positions in a rack are arranged numerically from 1-4, as displayed on the Rack
button.
Rack ID F1 (Button) Select to enter a new rack ID, or change the current rack ID. The Enter ID
field is displayed on the Rack button. For more information, see the Changing a
Rack ID procedure in Section 3.6: Editing Test Requests.
New Request F3 (Button) Select to exit this request and to make a new request. There are three
different request types.
information, see the Manual Test Requests procedure in Section 3.3: Patient Test
Requests, or see the Entering QC Test Requests procedure in Section 6.3: Running
Calibration F2
Maintenance F3
Maintenance Routines procedure.
Cancel Request F6 (Button) Select to cancel the requested maintenance routine and return to the
Sample Manager screen. For more information, see Section 3.6: Editing Test
Requests.
Figure 7-4 Maintenance Requests Screen Descriptions

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7.2: Daily Maintenance UniCel DxI Operator's Guide
7.2 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.
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.

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UniCel DxI Operator's Guide 7.2: Daily Maintenance
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
Figure 7-5 Daily Maintenance Flowchart

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Backing Up Use this procedure to back up the system each day to save your system data files.
the System
1. Perform an immediate system backup, or confirm that a scheduled system backup
successfully ran today. Recent backup information is displayed on the PC Admin
screen. For more information, see Section 2.6: Data Management in the
Reference Manual.
2. Record that the daily backup is complete on the Maintenance Log. Then continue
with the Recording the Test Count procedure.
Recording the The 10,000 and 5,000 test interval maintenance procedures are scheduled after the
Test Count UniCel DxI system runs a specific number of tests.
Use this procedure to record the test count. Schedule the test interval maintenance
procedures based on the daily instrument test count.

1. From the Event Log screen, select the most recent event listed on the screen.
2. Select Details F4 to display the Details window.
3. Find the test count listed in the Run Hours : Test Count field.
NOTE
The test count is the second number listed in this field.
4. Record the test count on the Maintenance Log.
5. Compare the test count to the test count value recorded when the 5,000 and
10,000 test interval procedures were last performed.
 (Optional) Schedule maintenance if maintenance is due.
6. Select OK F1 to exit the Details window. Then continue with the Shaking Down
the Solid Waste Container procedure.

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Shaking As the UniCel DxI system processes samples, waste accumulates in the solid waste
Down the container in a conical pattern. If the accumulated waste grows too high, it may
Solid Waste obstruct the waste chute and prevent the system from dispensing solid waste into the
container. To prevent this from occurring, use this procedure to shake down the
Container
container each day.
WARNING
CAUTIONS
• Do not press the green reset button after shaking down the solid waste
container. Pressing the green button resets the solid waste indicators. An
inaccurate solid waste count could cause the solid waste to overflow the
container or 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. For more information, see the Initializing the
System procedure in Section 4.2: Initialize System of the Reference
Manual, or see the Running Clean Routines in Section 7.2: Daily
Maintenance.
1. Open the solid waste door by pulling down on the handle (see Figure 2-30 in
Section 2.6: Solid Waste).
2. Reach into the storage area and grasp the solid waste container. Shake gently until
the accumulated waste is distributed evenly in the container.
3. Close the solid waste door.
4. Record that the waste container procedure is complete on the Maintenance Log.
Then continue with the appropriate clean routine. For more information, see the
Running Clean Routines procedure.

C73199-AA
Running Clean routines keep the sample, reagent, and aspirate probes clean and working
Clean properly. Run one of two clean routines each day as a part of daily maintenance.
Routines Use this procedure to run a clean routine. Once you prepare and load the rack, it takes
approximately ten minutes to complete the Daily Clean System routine, and
approximately thirteen minutes to complete the Special Clean routine.
CAUTION
Do not open the solid waste door while either clean routine is in progress.
Opening the solid waste door will cancel the routine and the system will enter
the Not Ready mode. For more information, see Shaking Down the Solid
Waste Container, or see Changing a Full Solid Waste Container in Section
2.6: Solid Waste.
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.
Required Materials
• 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

C73199-AA
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 on the
System Setup screen. For more information, see Section 2.2: System Setup in
Procedure Steps
System Mode: Ready
1. Confirm that the Utility routine is enabled. For more information, see the
Enabling and Disabling the Utility Routine procedure in Section 7.1:
Maintenance Overview. If the routine is not enabled, enable the routine and prime
the fluidics before you continue. For more information, see the Priming the
Fluidics procedure in Section 4.3: Prime Fluidics of the Reference Manual.
2. From the Sample Manager screen, select New Request F3, and then select
Maintenance F3 to display the Request Maintenance window.
3. Select either the Daily Clean System or the Special Clean option.
NOTE
Run the Special Clean routine if your laboratory has run the Vitamin B12 assay
during the last 24-hour time period. Otherwise, run the Daily Clean System
routine.

C73199-AA
4. Select OK F1 to display the Maintenance Requests screen.

The sample containers and contents for the selected routine are displayed on the
screen.
6. Place empty sample containers in positions 1 and 2 of an appropriate rack.
7. If you are running the Special Clean routine, also place an empty sample
container in position 3 of the rack.
WARNING
In the following steps, you will pipette solutions that may cause eye or skin
irritation. Handle according to proper laboratory procedures.
8. Pipette 3 mL of Contrad 70 cleaning solution into the sample container in

position 1.
9. Pipette 3 mL of a 1:5 dilution of Citranox cleaning solution into the sample

container in position 2.
WARNING
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.
10. If you are running the Special Clean routine, pipette 4 mL of a 70% ethanol or
methanol solution into the sample container in position 3.
11. Exit the Maintenance Requests screen.
12. Load the rack. For more information, see the Loading a Rack for Routine
Processing procedure in Section 3.4: Loading and Unloading Racks.
13. Record that the procedure is complete on the Maintenance Log. For more
information, see Section 7.6: Maintenance Log.

C73199-AA
UniCel DxI Operator's Guide 7.3: Special Weekly Maintenance
7.3 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. For more information, see the
Installing Clean Aspirate Probes procedure in Section 7.5: Test Interval Maintenance:
10,000 Tests.
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. For more information,
see Section 7.2: Daily Maintenance and see the Verifying System Performance
procedure in Section 7.4: Test Interval Maintenance: 5,000 Tests.
WARNINGS
• Never wear exposed metal that can come into contact with electrical
components of the instrument.
• You will come in contact with potentially infectious materials while
performing special weekly maintenance. Handle and dispose of biohazard
materials according to proper laboratory procedures. Proper hand, eye, and
facial protection is required.

C73199-AA
7.3: Special Weekly Maintenance UniCel DxI Operator's Guide
Begin special weekly

maintenance at the Device Diagnostics F4
Diagnostics menu
Device Diagnostics

the system
Open the right Perform daily maintenance *

main upper cover
Install clean aspirate Verify system performance *

probes *
* Record that the procedure

is complete on the
Close the right Maintenance Log
main upper cover
2301D.wmf
Figure 7-6 Special Weekly Maintenance Overview Flowchart

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UniCel DxI Operator's Guide 7.4: Test Interval Maintenance: 5,000 Tests
7.4 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.

C73199-AA
7.4: Test Interval Maintenance: 5,000 Tests UniCel DxI Operator's Guide
Begin 5,000 test

maintenance at the Device Diagnostics F4
Diagnostics menu
Device Diagnostics

the system
Open the right main upper Perform daily maintenance *

cover
Verify system performance *

Replace the duck bill valve *
Close the right main * Record that the procedure

upper cover is complete on the
Maintenance Log
2300D.wmf
Figure 7-7 Test Interval Maintenance (5,000 Tests) Overview Flowchart

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Replacing the Use this procedure to replace the duck bill valve. Replace the duck bill valve 5,000
Duck Bill tests after the valve was last replaced, or as instructed by the system documentation or
Valve by a technical support representative.
WARNINGS
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, confirm 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
• Duck bill valve
Removing the Used Duck Bill Valve
NOTE
If you are continuing to this procedure from 10,000 test interval maintenance,
begin at step 8.
1. From the Diagnostics menu, select Device Diagnostics F4 to display the Device
Diagnostics screen.
2. Open the right main upper cover. For more information, see Section 6.2:
Instrument Cover Procedures in the Reference Manual.
3. Locate the dispense probe plate. The dispense probe plate is the lower plate,
which contains the D1-D3 dispense probes (see Figure 7-8).

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2187C.eps
1 Sample rack used to position the dispense probe plate resting on

the incubator cover
2 D1, D2, D3 dispense probes
3 Dispense probe plate (lower plate)
4 A1 aspirate probe on the A1 aspirate probe support arm
5 Aspirate probe plate (upper plate)
Figure 7-8 Securing the Dispense Probe Plate
CAUTION
In the following step, do not lift up on the dispense probe plate at the D1
dispense probe position. The dispense probe plate can bend when lifted at
this position.
4. Locate the D2 dispense probe. At the D2 dispense probe position, place your
fingers underneath the dispense probe plate and lift up gently.
CAUTION
In the following step, be careful not to brush against the D1 dispense probe
or tubing while you position the sample rack. The probe will not function

C73199-AA
properly if it is bent, or if the tubing is routed incorrectly, kinked,

punctured, or torn.
5. Carefully slide a sample rack beneath the dispense probe plate. Position the rack
directly in front of the D3 dispense probe.
CAUTION
In the following two steps, handle the A1 aspirate probe and tubing with
extreme care. The probe is fragile and will not function properly if it is bent,
or if the tubing is routed incorrectly, kinked, punctured, or torn.
6. Gently grasp the A1 aspirate probe fitting, which is located just above the aspirate
probe plate. Turn the fitting counterclockwise until the probe is loose.
7. Carefully lift the A1 aspirate probe out of the aspirate probe plate and set the
probe down on several clean, lint-free tissues.
8. Locate the wash collar in the dispense probe plate (see Figure 7-9), which is
located to the right of the D2 dispense probe.
9. Grasp the collar from beneath the dispense probe plate, and turn it clockwise until
the plastic shoulder is aligned with the key slot in the dispense probe plate.
10. Carefully pull the wash collar down through the key slot. The duck bill valve is
on the underside of the collar.
11. Turn the retaining nut counterclockwise to remove the nut from the wash collar.
12. Lift the duck bill valve out of the retaining nut. Discard the valve in your
biohazard waste.

C73199-AA
A1

D2

2241C.eps
1 A1 aspirate probe fitting 2 D2 dispense probe fitting

3 A1 aspirate probe 4 Wash collar
5 Plastic shoulder of the wash collar 6 Retaining nut
7 Duck bill valve 8 Dispense probe plate
9 Key slot 10 Aspirate probe plate
Figure 7-9 Wash Collar and Duck Bill Valve

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Installing a New Duck Bill Valve

1. Insert a new duck bill valve into the retaining nut. Be sure the angled sides of the
new valve point through the opening in the nut (see Figure 7-10).
2303A.eps
1 Duck bill valve (angled sides pointing down)

2 Retaining nut
Figure 7-10 Inserting the Duck Bill Valve
2. To attach the nut to the wash collar, turn the retaining nut clockwise until it is
finger-tight.
WARNING
If the retaining nut is not finger-tight, the duck bill valve could fall into the
instrument during sample processing. This may affect your results.
3. Inspect the duck bill valve. The valve should be completely closed, or open no
more than a few thousandths of an inch (no more than the width of the valve on
either side of the opening).
4. If the valve is open too far, remove the duck bill valve and replace with a new
valve. Discard the faulty valve in your biohazard waste.
5. Grip the wash collar from beneath the dispense probe plate and align the plastic
shoulder with the key slot. Then carefully push the wash collar through the
opening.
6. Turn the collar counterclockwise to secure the plastic shoulder on the dispense
probe plate.
7. Grip the A1 aspirate probe by the probe fitting and lift the probe off the lint-free
tissue. Carefully lower the probe through the opening in the aspirate probe plate.
Turn the fitting clockwise until it is finger-tight. Be careful not to overtighten the
fitting.

C73199-AA
8. Verify the A1 aspirate probe deflection. Grip the aspirate probe above the probe
fitting and lift the probe approximately 1/4 inch (6.35 mm). Then release the
probe. The probe should snap back into position.
• If the probe does not snap back, the wash collar may not be positioned correctly
in the key slot. Check the wash collar position and correct if necessary (see
Figure 7-9). Verify the probe deflection again.
• If the wash collar is not the problem, the aspirate probe could be bent. It cannot be
straightened. Replace the aspirate probe with another clean probe. Then verify the
probe deflection. For more information, see the Installing Clean Aspirate Probes
procedure in Section 7.5: Test Interval Maintenance: 10,000 Tests.
• If the probe does not snap back after verifying the wash collar position and
replacing the probe, contact Technical Support for assistance.
10. If the 10,000 test interval maintenance procedures are scheduled for today,
continue with the Removing and Inspecting the Dispense Probes procedure next.
For more information, see Section 7.5: Test Interval Maintenance: 10,000 Tests.
11. If the 10,000 test interval maintenance procedures are not scheduled, perform the
following steps:
a. Confirm that the dispense probe tubing is routed correctly (see Figure 7-15
and see Figure 7-16). If the tubing is routed correctly, skip to step c.
• The D1 dispense probe tubing should be routed above the aspirate probe plate
and A1 aspirate probe support arm.
• The D2 and D3 dispense probe tubing should be routed behind and not beneath
the A1 and A2 aspirate probe support arms, respectively.
b. If the tubing is not routed correctly, remove the dispense probes and inspect
for kinked, punctured, or torn tubing. For more information, see the
Removing and Inspecting the Dispense Probes procedure.
• If the tubing is damaged, contact Technical Support for assistance.
• If the tubing is not damaged, return the dispense probes to their proper
positions and route the tubing correctly.
c. Remove the sample rack from beneath the dispense probe plate.
d. Close the right main upper cover. For more information, see Section 6.2:
e. Exit the Device Diagnostics screen.
f. Initialize the system. For more information, see Section 4.2: Initialize System
g. Perform daily maintenance and then verify system performance. For more
information, see Section 7.2: Daily Maintenance and see the Verifying
System Performance procedure.

C73199-AA
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 Figure 7-15
correctly
2240K.wmf
Figure 7-11 Test Interval Maintenance (5,000 Tests): Replacing the Duck Bill Valve Flowchart

C73199-AA
Verifying Verify system performance after completing maintenance on the duck bill valve or the
System aspirate and dispense probes, and before you process any samples. If you are
Performance performing other maintenance procedures, verify performance after you finish all
scheduled maintenance.
Use this procedure to verify system performance.
System Mode: Ready

1. Run a clean routine. For more information, see the Running Clean Routines
procedure in Section 7.2: Daily Maintenance.
NOTE
If you just completed daily maintenance, you have already completed this step.
Do not run a second clean routine.
2. Run QC for all assays you use to analyze patient samples. Evaluate out-of-range
QC results. For more information, see Chapter 6: Quality Control.

C73199-AA
7.5 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 on-board 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.

C73199-AA
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
Figure 7-12 Test Interval Maintenance (10,000 Tests) Overview Flowchart
Installing As the system processes samples, paramagnetic particles can accumulate inside the
Clean aspirate probe or on the probe exterior. A dirty aspirate probe can affect system
Aspirate performance.
Probes Use this procedure to install clean aspirate probes 10,000 tests after clean aspirate
probes were last installed.
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.

C73199-AA
Required Materials
• An empty sample rack
• Several clean, lint-free tissues
• Three clean aspirate probes
Removing the Aspirate Probes
WARNINGS
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.
• Handle each aspirate probe and its tubing with extreme care. The probes
are fragile and will not function properly if they are bent, or if the tubing
is routed incorrectly, kinked, punctured, or torn.
• Remove the aspirate probes one at a time. Do not replace all three
probes at once.
• Remove aspirate probes from the aspirate probe plate before
disconnecting the tubing fittings from the manifold. Fluid may leak out
of the probe and onto the analytical module cover if a fitting is
disconnected while an aspirate probe is still in the plate.
• Use extreme care when removing the A3 aspirate probe from the probe
plate. The probe is difficult to reach and could bend easily if it is not
handled carefully.
• Be sure that no tubing is routed between the aspirate and dispense probe
plates. Tubing routed between the probe plates will be pinched and may
tear open during normal operation.
Diagnostics screen.

C73199-AA
3. Locate the dispense probe plate. The dispense probe plate is the lower plate,
which contains the D1-D3 dispense probes (see Figure 7-8).
CAUTION
In the following step, do not lift up on the dispense probe plate at the D1
dispense probe position. The dispense probe plate can bend when lifted at
this position.
4. Locate the D2 dispense probe. At the D2 dispense probe position, place your
fingers underneath the dispense probe plate and lift up gently.
CAUTION
In the following step, be careful not to brush against the D1 dispense probe
or tubing while you position the sample rack. The probe will not function
properly if it is bent, or if the tubing is routed incorrectly, kinked,
punctured, or torn.
5. Carefully slide a sample rack between the dispense probe plate and the incubator
cover. Position the rack directly in front of the D3 dispense probe (see
Figure 7-8).
6. Locate the three aspirate probes on the aspirate probe plate. The probes are
labeled A1, A2, and A3 in sequence from right to left (see Figure 7-8).
CAUTION
For steps 7 to 12, remove only one aspirate probe at a time. Do not remove all
three probes at once.
7. Gently grasp one of the probe fittings and turn it counterclockwise until the probe
is loose (see Figure 7-13).
2264B.eps
1 Probe fitting
Figure 7-13 Loosening a Probe Fitting

C73199-AA
8. Lift the aspirate probe out of the aspirate probe plate and set the probe down on
several clean, lint-free tissues.
9. Locate the aspirate and dispense probe manifold (see Figure 7-14) by following
the aspirate probe tubing to the manifold. The aspirate and dispense probe
manifold is an upright plate positioned near the aspirate and dispense probe
plates. The manifold holds the probe tubing in a stationary position with a fitting
connection and routing clamps.
10. Find which routing clamp secures the probe tubing, and then lift up gently on the
tubing to release it from the clamp.
NOTES
• The A1 aspirate probe has two lines of tubing. Both lines are secured by
routing clamps located on the front manifold plate.
• The A2 and A3 aspirate probes each have one line of tubing. Each line of
tubing is secured by a routing clamp located on the rear manifold plate.
A3 A2 A1
D3 D2 A1W
D1
1
A3
D3
A2
A1W
D2
D1
A1
3
2
A1W
D2
D1
A1
2353A.eps
1 Aspirate and dispense probe tubing fitting connections (7)

2 Front manifold plate with aspirate and dispense probe tube
routing clamps (secures 4 lines of tubing)
3 Rear manifold plate with aspirate and dispense probe tube routing
clamps (secures 3 lines of tubing)
Figure 7-14 Aspirate and Dispense Probe Manifold

C73199-AA
CAUTION
In the following step, be sure that you remove the aspirate probe from the
aspirate probe plate before disconnecting the tubing fitting from the
manifold. Fluid may leak out of the probe and onto the analytical module
cover if a fitting is disconnected while its aspirate probe is still in the plate.
11. Turn the aspirate probe tubing fitting counterclockwise until it unlocks. After
unlocking the fitting, gently pull it toward you to disconnect the aspirate probe
and tubing from the manifold.
NOTES
• The A1 aspirate probe fittings disconnect from positions A1 and A1W.
• The A2 and A3 aspirate probe fittings disconnect from positions A2 and A3,
respectively.
• The line of tubing for the probe that disconnects from position A1W is
identified with a yellow sleeve. The tubing for the probes that disconnect
from positions A1, A2, and A3 is identified with a white sleeve.
12. Install a clean aspirate probe. For more information, see the Installing Clean
Aspirate Probes procedure.
13. Repeat steps 7-12 to remove and install the remaining aspirate probes.
Installing Clean Aspirate Probes

Always keep a spare set of new or cleaned aspirate probes in the CARE kit. Use this
procedure to install a clean aspirate probe as soon as a probe is removed.
WARNING
CAUTIONS
• Handle each aspirate probe and its tubing with extreme care. The probes
are fragile and will not function properly if they are bent, or if the tubing
is routed incorrectly, kinked, punctured, or torn.
• Use extreme care when installing the A3 aspirate probe. The opening in
the probe plate is difficult to reach, and the probe could bend easily if it
is not handled carefully.

C73199-AA
1. Follow steps a and b to connect the tubing fitting to the aspirate and dispense
probe manifold:
a. Locate the white or yellow colored sleeve attached to the aspirate probe
tubing, and check the probe number printed on the sleeve.
NOTES
• The A1 aspirate probe fittings connect to positions A1 and A1W.
• The A2 and A3 aspirate probe fittings connect to positions A2 and A3,
respectively.
• The A1, A2, and A3 tubing is identified with a white sleeve. The A1W tubing
is identified with a yellow sleeve.
b. Insert the aspirate probe tubing fitting into its corresponding position on the
aspirate and dispense probe manifold. Insert the tubing fitting into the
position on the manifold which corresponds to the probe number printed on
the sleeve. To connect the tubing fitting to the probe manifold, turn the fitting
clockwise until it locks in place (see Figure 7-14).
2. Follow steps a through c to secure the aspirate probe tubing to its routing clamp:
a. For the A1, A1W, A2, and A3 probe tubing, center the colored sleeve over
the appropriate routing clamp. Be sure the routing clamp corresponds to the
probe number printed on the sleeve.
NOTES
• Secure the A1 and A1W aspirate probe tubing to the routing clamps located
on the front manifold plate.
• Secure the A2 and A3 aspirate probe tubing to the routing clamps located on
the rear manifold plate.
b. Press down gently on the colored sleeve to secure it to the clamp.
c. Align the lower section of the A1 and A1W tubing over the lower routing
clamps on the front manifold plate, then press down gently on the tubing to
secure it to the clamp. The lower section of the A1 and A1W tubing does not
have a colored sleeve.
NOTE
The front manifold plate contains two clamps. Secure the tubing to both clamps.
CAUTION
In the following steps, do not return the A1 aspirate probe to its position in
the probe plate if you are performing your 5,000 test interval maintenance
procedures next. Let the probe rest on several clean, lint-free tissues until
you are instructed to return the probe during 5,000 test interval

C73199-AA
maintenance. Repeated handling increases the risk of damaging the probe or

tubing.
3. Correctly route the aspirate probe tubing above the aspirate probe plate (see
Figure 7-15 and see Figure 7-16). Any tubing routed between the aspirate and
dispense probe plates will be pinched and may tear open during normal operation.
2354A.eps
1 Dispense probe strain relief (in gray)

2 Correct: The dispense probe strain relief is not routed beneath the aspirate
probe plate and support arm
3 Correct: A1 aspirate probe tubing is routed above the aspirate probe plate
and support arm
Figure 7-15 Correctly Routed Dispense Probe Tubing Example
4. Hold the aspirate probe by the probe fitting, and then lower the probe through the
opening in the aspirate probe plate.
5. Turn the probe fitting clockwise until the fitting is finger-tight. Be careful not to
overtighten the fitting.

C73199-AA
6. Be sure you do not route the aspirate tubing beneath the aspirate probe plate. Any
tubing routed between the aspirate and dispense probe plates will be pinched and
may tear open during normal operation (see Figure 7-16).
2315A.eps
1 A1 aspirate probe plate support arm
2 Incorrect: D1 dispense probe tubing routed beneath the A1
aspirate probe plate support arm
3 Incorrect: D2 dispense probe tubing routed beneath the A1
aspirate probe plate support arm
Figure 7-16 Incorrectly Routed Dispense Probe Tubing Example
7. Verify the aspirate probe deflection. Grip the aspirate probe above the probe
fitting and lift the probe approximately 1/4 inch (6.35 mm). Then release the
probe. The probe should snap back into position.
• If the probe does not snap back, the probe will not function properly and should
be removed. Replace the aspirate probe with another clean probe. Then verify the
probe deflection.
• If the probe does not snap back after it is replaced, contact Technical Support for
assistance.
8. Remove the next aspirate probe. For more information, see the Removing the
Aspirate Probes procedure.
9. Repeat steps 1 through 8 to install another clean aspirate probe. Continue until
each probe is clean.

C73199-AA
11. If you are only installing clean aspirate probes, or are installing clean aspirate
probes as part of special weekly maintenance, end the procedure with the steps
listed below. Otherwise, continue with step 12 of this procedure.
a. Confirm that the dispense probe tubing is routed correctly (see Figure 7-15
and see Figure 7-16).
• The aspirate and dispense probe tubing should not be routed beneath the
aspirate probe plate or aspirate probe support arms.
• Place two fingers underneath the aspirate probe plate, then gently move the
plate up and down to be sure there is no interference from incorrectly
routed aspirate or dispense probe tubing.
If the tubing is routed correctly, skip to step c.
b. If the tubing is not routed correctly, remove the dispense probes from the
dispense probe plate and inspect for kinked, punctured, or torn tubing. For
more information, see the Removing and Inspecting the Dispense Probes
procedure.
• If the tubing is not damaged, return the dispense probes to their proper
positions and route the tubing correctly.
c. Remove the sample rack from beneath the dispense probe plate.
d. Close the right main upper cover. For more information, see Section 6.2:
e. Exit the Device Diagnostics screen.
f. Initialize the system. For more information, see Section 4.2: Initialize System
g. If you are not continuing with either the 5,000 or 10,000 test interval
maintenance procedures, perform daily maintenance and then verify system
performance. For more information, see Section 7.2: Daily Maintenance and
see the Verifying System Performance procedure.
12. If you scheduled the 5,000 test interval maintenance procedures for today, replace
the duck bill valve now. Begin at step 8 of the Removing the Used Duck Bill
Valve procedure. For more information, see Section 7.4: Test Interval
Maintenance: 5,000 Tests.
13. If the 5,000 test interval maintenance procedures are not scheduled, continue with
the 10,000 test interval procedures. Perform the Removing and Inspecting the
Dispense Probes procedure next.

C73199-AA
14. Clean the removed aspirate probes after you complete all other maintenance
procedures. For more information, see the Cleaning the Aspirate Probes
procedure.
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
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
Figure 7-15 correctly probe plate
2266K.wmf
Figure 7-17 Test Interval Maintenance (10,000 Tests): Installing Clean Aspirate Probes Flowchart

C73199-AA
Cleaning the Use this procedure to clean the aspirate probes. Clean the aspirate probes you
Aspirate removed from the instrument at your earliest opportunity. Store the clean probes in
Probes your CARE kit for the next time you install clean aspirate probes.
CAUTION
Handle the aspirate probes and tubing with extreme care. The probes are
fragile and will not function properly if they are bent, or if the tubing is
routed incorrectly, kinked, punctured, or torn.
Required Materials
• 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
Precleaning the Aspirate Probe Interior
WARNINGS
• The disposable aspirate probe brush is considered a biohazard after it has
been used to clean from 1 to 3 aspirate probes. Discard the brush with your
biohazard waste. Do not save a used brush for future use.
1. Fill a small beaker with approximately 20 mL of Contrad 70 cleaning solution.
2. Dip the aspirate probe brush in the Contrad 70 cleaning solution.
WARNING
In the following two steps, inserting and removing the aspirate probe brush can
disperse biohazard materials that are lodged inside the probe. Work carefully to
prevent scattering small droplets of these materials into the air.
3. Insert the aspirate probe brush into the tip of the aspirate probe and gently push
the brush inside the probe until you feel it come to a stop.
4. Remove the brush.
5. Repeat steps 2-4 several times on the same probe, or until no orange colored
residue is visible on the brush when it is removed from the probe.

C73199-AA
Washing the Aspirate Probe Interior

1. Fill a small beaker with approximately 50 mL of deionized water.
2. Place the aspirate probe tubing fitting in the beaker of deionized water. Be sure
the fitting is completely submerged in the water.
NOTE
For the A1 aspirate probe, be sure both tubing fittings are submerged.
3. Attach the syringe fitting assembly to the syringe (see Figure 7-18).
0400e.eps
1 Syringe
2 Syringe fitting assembly
Figure 7-18 Attaching the Syringe Fitting Assembly
4. Push the aspirate probe tip into the open end of the tubing on the syringe fitting
assembly.
CAUTION
In the following step, only draw deionized water through the probe tubing
fitting. Do not push water from the syringe through the aspirate probe,
because this could damage the probe and tubing fitting.
5. Draw deionized water through the probe tubing fitting and into the syringe.
6. Remove the syringe from the syringe fitting assembly and push the deionized
water out of the syringe and into a sink.
7. Reattach the syringe to the syringe fitting assembly and repeat steps 5-6 two more
times.
8. Remove the aspirate probe fitting from the beaker of deionized water.

C73199-AA
9. Reattach the syringe to the syringe fitting assembly.

10. Draw air through the probe tubing fitting and into the syringe.
11. Remove the syringe from the fitting assembly, and then gently remove the
assembly from the aspirate probe tip.
12. Position the probe upright on absorbent paper for about 10 minutes to drain any
residual fluid.
Cleaning the Aspirate Probe Exterior

1. Gently wipe down the exterior of the detached aspirate probe with an alcohol
wipe.
2. Store the clean aspirate probe in your CARE kit.
Brush out the inside of the

Remove aspirate probe
aspirate probe with
fitting from deionized water
Contrad 70
Reattach the syringe to the

Place the aspirate probe fitting assembly and draw air
fitting in deionized water through the tubing fitting and
into the syringe
Attach the syringe fitting Disconnect the syringe and

assembly to the aspirate fitting assembly from the
probe tip probe tip
Draw deionized water Position the probe upright on

through the tubing fitting and absorbent paper for 10
into the syringe minutes
Disconnect the syringe from Wipe down the aspirate

the fitting assembly and probe exterior with an
discard the water in the sink alcohol wipe
Reattach the syringe to the

fitting assembly and draw Store the clean aspirate
and discard water two more probes in your CARE kit
times
2267C.wmf
Figure 7-19 Cleaning an Aspirate Probe Flowchart

C73199-AA
Removing Use this procedure to remove and inspect all three dispense probes 10,000 tests after
and the probes were last inspected.
Inspecting the As the system processes samples, crystalline deposits can accumulate on the dispense
Dispense probe exterior and affect system performance.
Probes
WARNINGS
CAUTIONS
• Handle each dispense probe and its tubing with extreme care. The
probes are fragile and will not function properly if they are bent, or if
the tubing is routed incorrectly, kinked, punctured, or torn.
• Do not disconnect the dispense probe tubing fitting from the aspirate
and dispense probe manifold. All wash buffer in the line will leak out
into the instrument if the fitting is disconnected.
• Use extreme care when handling the D3 dispense probe from the
dispense probe plate. The probe is difficult to reach and could bend
easily if it is not handled carefully.
• Remove and inspect the dispense probes one at a time. Do not try to
remove and inspect all three probes at once.

Diagnostics screen.
3. Locate the three dispense probes. The probes are labeled D1, D2, and D3 in
sequence from right to left (see Figure 7-8).
CAUTION
In the following steps, do not disconnect the dispense probe tubing fitting
from the aspirate and dispense probe manifold. All wash buffer in the line
will leak out into the instrument if the fitting is disconnected.

C73199-AA
4. Visually inspect the dispense probes for kinked, punctured, or torn tubing, and for
crystalline deposits or corrosion at the tubing connections and fittings.
Kinked, punctured, or torn tubing can affect system performance. Deposits or
corrosion can indicate that a connection or fitting is leaking. Contact Technical
Support for assistance if you find damaged tubing, or if you find deposits or corrosion
on the probe fittings.
5. Gently grasp the probe fitting located on the dispense probe plate and turn it
counterclockwise until the probe is loose (see Figure 7-13).
6. Lift the dispense probe out of the dispense probe plate. Do not disconnect the
dispense probe tubing from the routing clamps located on the aspirate and
dispense probe manifold (see Figure 7-14).
If the dispense probe tubing is loose, secure the tubing to the appropriate routing
clamp by centering the colored sleeve over the routing clamp. Be sure the probe
number printed on the yellow sleeve corresponds to the routing clamp. Then, press
down gently on the tubing to hold it in place.
7. Inspect the dispense probe for crystalline deposits on the probe exterior.
8. If there are deposits on the probe, moisten a lint-free tissue with deionized water
and wipe down the probe exterior.
9. Correctly route the dispense probe tubing above or behind the aspirate probe plate
support arms (see Figure 7-15 and see Figure 7-16).
NOTES
• Route the D1 dispense probe tubing above the aspirate probe plate and A1
aspirate probe support arm.
• Route the D2 and D3 dispense probe tubing behind and not beneath the A1
and A2 aspirate probe support arms, respectively.
• Each dispense probe is fitted with a strain relief, which helps route the
dispense probe tubing toward the aspirate and dispense probe manifold. Be
sure the strain relief is not routed beneath the aspirate probe plate (see
Figure 7-15). The strain relief will be pinched and may tear open during
normal operation if it is routed between the aspirate and dispense probe
plates.
10. Hold the dispense probe by the probe fitting, and then lower the probe through the
opening in the dispense probe plate.
11. Turn the probe fitting clockwise until the fitting is finger-tight.
12. Repeat steps 5 through 11 to individually remove and inspect each remaining
dispense probe.

C73199-AA
14. Confirm that the dispense probe tubing is routed correctly (see Figure 7-15 and
see Figure 7-16).
• The aspirate and dispense probe tubing should not be routed beneath the aspirate
probe plate or aspirate probe support arms.
• Place two fingers underneath the aspirate probe plate, then gently move the plate
up and down to be sure there is no interference from incorrectly routed aspirate or
dispense probe tubing.
If the tubing is routed correctly, skip to step 16.
15. If the tubing is not routed correctly, remove the dispense probes from the
dispense probe plate and inspect for kinked, punctured, or torn tubing.
• If the tubing is not damaged, return the dispense probes to their proper positions
and route the tubing correctly.
16. Remove the sample rack from beneath the dispense probe plate.
17. If you are continuing with 10,000 test interval maintenance, perform the
Inspecting the Pump Connections at the Wash Buffer Reservoir procedure next.
18. If you are not continuing with 10,000 test interval maintenance, perform the
following steps:
a. Close the right main upper cover. For more information, see Section 6.2:
b. Exit the Device Diagnostics screen.
c. Initialize the system. For more information, see Section 4.2: Initialize System
d. Verify system performance. For more information, see the Verifying System
Performance procedure in Section 7.4: Test Interval Maintenance: 5,000
Tests.

C73199-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
Locate the dispense probes
and inspect the tubing
connections and fittings Place the dispense probe in
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
inspected?
Yes
Continue with
10,000 test
No Close the right
main upper cover
Record that the procedure is maintenance?
complete on the
Maintenance Log
Yes
screen and Initialize
Confirm that the dispense the system
Inspect pump connections at
probe tubing is routed
the wash buffer reservoir
correctly
Verify system performance
2268J.svg
Figure 7-20 Test Interval Maintenance (10,000 Tests): Removing and Inspecting the Dispense
Probes Flowchart

C73199-AA
Inspecting the Use this procedure to visually inspect the pump connections at the wash buffer
Pump reservoir. The wash buffer reservoir is located beneath the left main upper cover.
Connections
WARNINGS
at the Wash
Buffer
Reservoir
System Mode: Not Ready

1. Open the left main upper cover. For more information, see Section 6.2:
2. Visually inspect the following locations (see Figure 7-21) for kinked tubing and
for crystalline deposits or corrosion at the tubing connections. The connections
you will inspect are colored red.
• Sample pump connection
• Precision pump connections
• Wash pump connections
2
1
4
2124A.eps
1 Sample pump connection

2 Precision pump connections (4)
3 Wash pump connections (6)
4 Wash buffer reservoir
Figure 7-21 Inspecting the UniCel DxI 800 Wash Buffer Reservoir Pump
Connections

C73199-AA
1 2
4
2124B.eps
1 Sample pump connection

2 Precision pump connections (2)
3 Wash pump connections (6)
4 Wash buffer reservoir
Figure 7-22 Inspecting the UniCel DxI 600 Wash Buffer Reservoir Pump
Connections
3. If you find any kinked tubing, deposits, or corrosion contact Technical Support
for assistance.
Kinked tubing can affect precision. Deposits or corrosion can indicate that a
connection or fitting is leaking.
4. If you are performing 10,000 test interval maintenance, record that the inspection
is complete on the Maintenance Log. Perform the Inspecting the Upper Aspirate
Peristaltic Pump Connections procedure next.

C73199-AA
Inspecting the Use this procedure to visually inspect the upper aspirate peristaltic pump connections
Upper and tubing. The upper aspirate peristaltic pump is located beneath the right main
Aspirate upper cover and to the right of the wash buffer reservoir.
Peristaltic WARNINGS
Pump
Connections components of the instrument.

1. Begin this procedure with the right main upper cover open. For more information,
see Section 6.2: Instrument Cover Procedures in the Reference Manual.
2. Visually inspect the following locations (see Figure 7-23) for kinked tubing, and
for crystalline deposits or corrosion at the tubing connections and fittings.
• Pump channels (three on either side of the pump)
• Pump manifold
NOTE
UniCel DxI systems are configured with one of the perstaltic pump
configurations shown in Figure 7-23. This procedure is appropriate for use with
either configuration.
1 1
2
2
3
3
2261B.eps 3009A.eps

C73199-AA
1 Upper aspirate peristaltic pump

2 Pump channels (3)
3 Pump manifold
Figure 7-23 Inspecting the Upper Aspirate Peristaltic Pump Connections
3. If you find any kinked tubing, deposits, or corrosion, contact Technical Support
for assistance.
Kinked tubing can affect system performance. Deposits or corrosion can indicate that
a connection or fitting is leaking.
is complete on the Maintenance Log. Perform the Inspecting the Reagent
Pipettors and Cleaning the Wash Towers procedure next.

C73199-AA
Inspecting the Use this procedure to inspect and clean the reagent pipettors and the wash towers. The
Reagent pipettors and towers are located beneath the left upper main cover. It is not necessary
Pipettors and to inspect or clean the sample pipettor.
Cleaning the WARNINGS

Wash Towers

1. Begin this procedure with the left main upper cover open. For more information,
see Section 6.2: Instrument Cover Procedures of the Reference Manual.
2. Locate the reagent pipettors. The reagent pipettors are mounted on separate
pipettor assemblies (for the UniCel DxI 800 instrument, see Figure 7-24; for the
UniCel DxI 600 instrument, see Figure 7-25).
3. Visually inspect the reagent pipettor fluidic lines for kinked tubing and for
crystalline deposits or corrosion at the tubing connections, and inspect the tubing
near the top of the pipettor for leaks.
4. If you find any kinked tubing, deposits, corrosion, or leaks, contact Technical
Support for assistance.
Kinked tubing can affect precision. Deposits or corrosion can indicate that a
connection or fitting is leaking.
5. Locate the wash towers. The reagent pipettor wash towers are underneath the
reagent pipettors on the lower right side. The sample pipettor wash tower is
underneath the sample pipettor on the lower left side of the instrument.

C73199-AA
1 4 2
5 4 3
2330B.eps
1 Vessel hopper
2 Reagent pipettor assemblies (4)
3 Reagent pipettor wash towers (4)
4 Circuit board (1), beneath or to the side of the vessel hopper
5 Sample pipettor wash tower
Figure 7-24 UniCel DxI 800 Wash Tower Locations

C73199-AA
1
4 2
5 4 3
2244G.eps
1 Vessel hopper
2 Reagent pipettor assemblies (2)
3 Reagent pipettor wash towers (2)
4 Circuit board (1), beneath or to the side of the vessel hopper
5 Sample pipettor wash tower
Figure 7-25 UniCel DxI 600 Wash Tower Locations
6. Check inside the wash tower overflow reservoirs for liquid or excessive
crystalline deposits (see Figure 7-26).
7. If you find liquid or excessive crystalline deposits in one or more reservoirs,

Liquid or excessive deposits can indicate that a connection or fitting is leaking, or that
a pipettor is aligned incorrectly.
8. Wet a lint-free swab (or equivalent fiber-free applicator) with deionized water
and wipe any deposits from the reservoirs and exterior of the wash towers.

C73199-AA
2262B.eps
1 Wash tower overflow reservoir
Figure 7-26 Inspecting the Wash Tower Reservoirs
is complete on the Maintenance Log. Perform the Inspecting for Fallen RVs
procedure next.
Inspecting for Use this procedure to visually inspect for RVs that have fallen and are loose inside of
Fallen RVs the instrument.
WARNINGS

C73199-AA

1. Begin this procedure with the left and right main upper covers open. For more
information, see Section 6.2: Instrument Cover Procedures of the Reference
Manual.
2. Visually inspect for fallen RVs beneath the vessel hopper. Also inspect around
the reagent pipettor and sample pipettor carriages (see Figure 7-24), being sure to
look around the belts for RVs.
WARNINGS
• The carriages contain many mechanical parts which could puncture the
skin. Proper hand, eye, and facial protection is required. Always be careful
when reaching for an RV.
• When reaching for an RV, be careful not to touch the circuit board beneath
or to the side of the vessel hopper. You can disturb important electronic
connections if you brush against the board.
3. If you find any fallen RVs, carefully remove them from the instrument and
dispose of them with your biohazard waste.
4. If you cannot remove an RV that is contributing to a system problem, contact
Technical Support for assistance.
5. Close both main upper covers. For more information, see Section 6.2: Instrument
Cover Procedures in the Reference Manual.
6. Exit the Device Diagnostics screen.
7. Initialize the system. For more information, see Section 4.2: Initialize System in
is complete on the Maintenance Log. If your DxI system uses on-board bulk
liquid waste containers, perform the Inspecting the Liquid Waste Drawer
procedure next. If your system uses a liquid waste drain, perform the Inspecting
the Wash Buffer Supply Drawer procedure next.

C73199-AA
Inspecting the If your system uses on-board bulk liquid waste containers, use this procedure to
Liquid Waste visually inspect the liquid waste drawer for leaks. The liquid waste drawer is located
Drawer on the lower left as you face the instrument. If your system uses a liquid waste drain,
skip this procedure.
WARNING

1. Pull out the liquid waste drawer. For more information, see Section 2.5: Liquid
Waste.
2. Check for any liquid outside of the bulk liquid waste containers, either pooled on
top of one or both of the bulk liquid waste containers, or at the bottom of the
liquid waste drawer.
Liquid waste can indicate that there is a leak in the fluidic drawer located above the
liquid waste drawer.
3. If there is any liquid outside of the bulk liquid waste containers, handle and
decontaminate the waste according to proper laboratory procedures. Then contact
Technical Support.
4. Check the connections at the back of the drawer for crystalline deposits or
corrosion at the tubing connections.
5. If you find any deposits or corrosion, contact Technical Support for assistance.
The presence of deposits or corrosion can indicate that a connection or fitting is
leaking.
6. Close the liquid waste drawer.
is complete on the Maintenance Log. Perform the Inspecting the Wash Buffer
Supply Drawer procedure next.

C73199-AA
Inspecting the Use this procedure to visually inspect the wash buffer supply drawer. The wash buffer
Wash Buffer supply drawer is located on the lower right as you face the instrument.
Supply
WARNING
Drawer
suitable gloves.

1. Pull out the wash buffer supply drawer. For more information,
see Section 2.3: Wash Buffer.
2. Check the condition of both bulk wash buffer containers. Be sure the containers
are in good condition and are not beginning to collapse.
A collapsing container can indicate that the wash buffer cap filter is clogged and is
creating a vacuum.
3. If one or both containers are collapsing, contact Technical Support.
4. Check for any wash buffer outside of the bulk wash buffer containers, either
pooled on top of one or both of the containers, or at the bottom of the wash buffer
supply drawer.
The presence of wash buffer can indicate that there is a leak in the tubing, or that the
cap and tube assembly is loose or connected incorrectly.
5. If you find that the cap and tube assembly is loose, reconnect the assembly. For
more information, see the Changing an Empty Bulk Wash Buffer Container
procedure in Section 2.3: Wash Buffer.
6. If you find a leak in the wash buffer tubing, contact Technical Support for
assistance.
7. Check the tubing and connections at the back of the drawer for kinks, or
crystalline deposits and corrosion at the tubing connections.
8. If you find any kinks, deposits, or corrosion, contact Technical Support for
assistance.
Deposits or corrosion can indicate that a connection or fitting is leaking.
9. Close the wash buffer supply drawer.
is complete on the Maintenance Log. Perform the Cleaning the Air Filter
procedure next.

C73199-AA
Cleaning the Use this procedure to clean the air filter. The air filter is located behind the lower right
Air Filter door as you face the instrument.
WARNING
Use extreme caution when handling the air filter. The filter edges are sharp and
can puncture the skin if the air filter is handled carelessly.
CAUTION
Do not run the instrument if the air filter is not in place. Running without the
air filter may result in dust buildup on critical instrument components.
Required Materials
• Hand-held vacuum device

1. Place your finger in the indentation between the wash buffer supply drawer and
the lower right door. Open the lower right door by swinging it outward.
2. Locate the air filter near the bottom of the cabinet (see Figure 7-27).
3. Grasp the filter by its metal frame and slide the filter out of the filter housing.
4. Turn the filter over so the screen cage faces the floor, and then lay the filter down
on a solid surface.
5. Vacuum the filter until most of the dust and dirt is removed.
6. Turn the filter so the screen cage faces up and slide the filter into the filter
housing.
7. When the air filter is inside the housing, gently close the lower right door.
8. If you are performing 10,000 test interval maintenance, record that the filter is
clean on the Maintenance Log. Then perform the following steps:
a. Perform daily maintenance. For more information, see Section 7.2: Daily
Maintenance.
b. Verify system performance. For more information, see the Verifying System
Performance procedure.

C73199-AA
1 2
3
2243A.eps
1 Wash buffer supply drawer

2 Filter housing
3 Lower right door (open)
4 Indentation in the lower right door
5 Air filter (screen cage facing up)
Figure 7-27 Air Filter Location

C73199-AA
7.6: Maintenance Log UniCel DxI Operator's Guide
7.6 Maintenance Log
Use the Maintenance Log as a checklist to confirm that you perform each routine
maintenance procedure. The log also serves as a daily record of the instrument test
count. One month of routine maintenance can be recorded on the log.
Review the instrument test count daily and schedule the test interval maintenance
procedures as needed, based on the number of tests you run on the instrument. If your
laboratory runs tests for HIV antibody levels, review the log and schedule special
weekly maintenance accordingly.
Use the Maintenance Log in the Instructions for Use manual as an original and make
photocopies for use with each UniCel DxI system in your laboratory. You can also
print copies of the Maintenance Log from the Help system. Beckman Coulter
recommends that you save completed Maintenance Logs in your Maintenance and
Service Log binder for reference.

C73199-AA
Maintenance Log Serial # __________System ID ___________ Month ______ Year ______ Beckman Coulter, Inc. UniCel DxI System
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
C73199-AA
(Turn form to record number)
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

or the Special Clean Routine (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 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

Verify System Performance (Run Clean Routine and QC)
Tech Initials
10,000 TEST INTERVAL MAINTENANCE On Date On Date On Date

Complete the maintenance procedures in the order listed in
Install Clean Aspirate Probes each table. When a maintenance procedure is complete, draw
Remove and Inspect Dispense Probes a check () or circle the code in the corresponding box.
Inspect the Pump Connections at the Wash Buffer Reservoir When all procedures are complete for a scheduled
maintenance, add your initials. Add the date and test count as
Inspect the Upper Aspirate Peristaltic Pump Connections
appropriate.
Inspect the Reagent Pipettors and Clean the Wash Towers
If you schedule the 10,000 and 5,000 test interval
Inspect for Fallen RVs
maintenance procedures consecutively, perform the 10,000
If your system uses bulk liquid waste containers, inspect the Liquid Waste Drawer test interval procedures first. Perform the daily maintenance
Inspect the Wash Buffer Supply Drawer procedures after you complete the special weekly maintenace
Clean the Air Filter procedure, or the 10,000 and 5,000 test interval procedures.
Verify System Performance (Run Clean Routine and QC) When you combine daily maintenance with special weekly or
Tech Initials test interval maintenance, you only need to run a clean routine
once in your final maintenance step.
7: Routine Maintenance
7-63
This page may be reproduced for laboratory use.
7.6: Maintenance Log UniCel DxI Operator's Guide

C73199-AA
UniCel DxI Operator's Guide A: Sample Racks and Containers
A Sample Racks and

Containers
A.1 Sample Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-2
Rack Sizes and Containers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Cleaning Sample Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
A.2 Sample Containers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-4
Calculating Minimum Sample Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
Sample Containers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . -8
© 2021 Beckman Coulter, Inc. A-1

C73199-AA
A.1: Sample Racks UniCel DxI Operator's Guide
A.1 Sample Racks

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.
There are four sample rack sizes.
• 13x75 mm
• 13x100 mm
• 16x75 mm
• 16x100 mm
Sample racks are identified by four different types of labels.

• Container type label
• Rack bar code label
• Rack ID label
• Reserve Volume label
The container type label includes an illustration of the only sample container type you
can use with the rack. The rack bar code label includes the bar code and rack ID
number. 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
identifies the type of reserve volume 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. For more information, see Section 2.3: Supplies Setup in
The instrument recognizes the type of sample containers held in the sample rack when
it scans the rack bar code label.
For information about attaching labels to racks, see Section 2.3: Supplies Setup in the
Reference Manual.
A-2 © 2021 Beckman Coulter, Inc.

C73199-AA
UniCel DxI Operator's Guide A.1: Sample Racks
Rack Sizes The following table lists the different sizes of racks, and the accepted container types
and for each rack size. For more information about sample containers, see
Containers Section A.2: Sample Containers.
CAUTION
A rack is configured to accept only one type of sample container. Do not mix
types of containers within a rack. You can find the rack ID ranges set up for
each type of container from the System Setup screen. For more information,
see Section 2.3: Supplies Setup in the Reference Manual.
Rack Size Accepted Sample Containers

13x75 mm • 11.5x66 mm 3.5 mL S.60.549 Sarstedt tube
• 12 or 13x75 mm glass tube
• 12 or 13x75 mm plastic tube
• 0.5 mL cup
• 2 mL cup
• 1 mL insert cup in a 13x75 mm tube
13x100 mm • 13x100 mm tube
• 0.5 mL cup
• 2 mL cup
• Pediatric insert cup in a pediatric tube adapter
• Autoaliquot tube
16x75 mm • 16x75 mm tube
• 75x15 mm 5.5 mL Sarstedt S-Monovette* tube
16x100 mm • 15.3x92 mm 5 mL S.62.611 Sarstedt tube
• 16x85 mm tube
• 16x100 mm tube
• 92x15 mm 7.5 mL Sarstedt S-Monovette tube
• 3 mL cup
Table A-1 Rack Sizes and Container Types

* Monovette is a trademark of Sarstedt AG & Co.
Cleaning You can clean your sample racks in a dishwasher or an autoclave. You can also wash
Sample Racks the racks by hand using a brush and a mild detergent.

C73199-AA
A.2: Sample Containers UniCel DxI Operator's Guide
A.2 Sample Containers

Place sample containers into the four available positions in a rack. Each rack is
identified by a container type label that illustrates the specific type of sample
container you can use with the rack. When the UniCel DxI system scans the rack, the
bar code label identifies the type of containers in the rack. If your laboratory uses
sample bar code labels, the system identifies the sample inside the container and the
associated test requests when it scans the bar code.
NOTE
You can load patient and QC samples in the same rack as long as the samples are
in the same type of container. A rack that contains calibrators cannot include
patient or QC samples.
Place most containers directly in a rack. If you use insert cups, place the cups into the
appropriate containers or rack inserts before placing them in a rack. For more
information about loading racks, see Section 3.4: Loading and Unloading Racks.
WARNINGS
• Because the system software contains specific parameters for each of the
valid sample containers, only use the recommended containers on the
UniCel DxI instrument. Other containers may damage the system and
compromise the integrity of your test results.
• A rack is configured to accept only one type of sample container. 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. For more information, see
Section 2.2: System Setup in the Reference Manual.
CAUTION
system.

C73199-AA
UniCel DxI Operator's Guide A.2: Sample Containers
Calculating The sample volume in a container must be sufficient to process the requested tests,
Minimum and can be increased to accommodate reflex tests or patient and QC reruns. For more
Sample information about setting the reserve volume, see Section 3.7: Reflex Test Setup in
Volume
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
The sample assay volume is the sum of the sample volumes for each requested test. To find the
A
sample volume for each test, see the corresponding reagent instructions for use.
The system dead volume is the amount of sample that cannot be drawn from an RV inside of the
B
instrument. The system dead volume is 60 mL for each RV.
(If set up) The reserve volume is the amount of sample the system stores for additional testing. For
C more information, see the Setting Up Reserve Volume topic in Section 3.7: Reflex Test Setup of the
Reference Manual.
The sample pipettor overdraw is 20 mL or 5% of the volume of sample in the RV (A + B + C),
D
whichever is greater.
The sample container dead volume is the amount of sample that cannot be aliquoted from the sample
E
container. To find the dead volume for a specific sample container, see Table A-2.
NOTE
If the sum of the sample and reserve volumes (A + C) is greater than 500 mL, the
system aliquots the reserve volume into 1-2 additional RVs. For each additional
RV, include the system dead volume and the calculated amount of sample
pipettor overdraw.

C73199-AA
Example
Sample volume aliquot in one RV - The PSA assay has a sample volume of
25 mL, and the fPSA assay has a sample volume of 25 mL. The system is set up to
draw 200 mL 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.
Total sample volume for the requested tests 50 mL

A
(25 mL + 25 mL)
B System dead volume for one RV 60 mL
C Reserve volume 200 mL

Overdraw of 20 mL or 5% of the volume in the RV, whichever is 20 mL
larger
D
One RV: 5% of (50 mL + 60 mL + 200 mL) = 16 mL,
so use an overdraw of 20 mL
E Dead volume for a 2 mL cup (see Table A-2) 150 mL
Minimum sample volume required for one RV 480 mL
Example
Sample volume aliquot in two RVs - The PSA assay has a sample volume of
25 mL, and the fPSA assay has a sample volume of 25 mL. The system is set up to
draw 500 mL 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.
.
Total sample volume for the requested tests 50 mL

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

C73199-AA
UniCel DxI Operator's Guide A.2: Sample Containers
Sample The following table lists the sample containers that are accepted on the UniCel DxI
Containers instrument, along with their dead volume requirements.
WARNING
Racks are configured to accept only one type of sample container. Sample
containers must match the ID configured for the racks you use. 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. For more information, see
Section 2.2: System Setup in the Reference Manual.
CAUTION
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 mL
12/13
x75
12 or 13x75 mm plastic tube 13x100 mm tube

Plastic
• Dead volume: 200 mL • Dead volume: 500 mL
12/13
x75 13x100
15.3x92 mm 5 mL S.62.611 16x75 mm tube

Sarstedt tube • Dead volume: 800 mL
16x75
Table A-2 Sample Containers and Their Dead Volume Requirements

C73199-AA
Container Type Container Type

Sample Container Information Sample Container Information
Label Label
16x85 mm tube 16x100 mm tube
(This information only
applies to the 16x85 mm
SBCL 10 mL screw-cap tube)
16x85 16x100
75x15 mm 5.5 mL 92x15 mm 7.5 mL

Sarstedt S-Monovette tube Sarstedt S-Monovette tube
1 mL insert cup in a 13x75 tube 1 mL insert cup in a 13x100 mm tube

Insert
Insert
1 mL in 1 mL in
13x75 13x100
0.5 mL cup 2 mL cup
2 mL
2 mL insert cup in a 16x100 mm 3 mL cup in a 16x100 mm rack

Insert
tube • Dead volume: 150 mL

2 mL in
16x100 3 mL
Autoaliquot tube Pediatric insert cup in a pediatric

• Dead volume: 150 mL tube adapter
Aliquot PED
Table A-2 Sample Containers and Their Dead Volume Requirements (continued)

C73199-AA
UniCel DxI Operator's Guide Index
Index
electrical warning 7-33
Symbols handling with caution 7-33
10,000 test maintenance HIV testing and maintenance 7-19
overview 7-3 installing (flowchart) 7-41
procedures 7-31 installing clean 7-36
5,000 test maintenance loosening fittings 7-34
overview 7-3 positions 7-34
procedures 7-21 potentially infectious 7-33, 7-42
removing 7-33
A replacing 7-32
Access Immunoassay Systems syringe assembly 7-43
family 1-2 verifying deflection 7-28, 7-39
UniCel DxI 1-2 assay calibrations
active calibrations 5-27 active 5-27
switching 5-32 calibration data report 5-33
calibration report 5-8
AEX result flag 4-27
calibration screen 5-5
air bubbles
calibration screen filter 5-6
prevent when pipetting 3-43
calibrator setup 5-10
air filter comments 5-33
cleaning 7-60 curves 5-26
location 7-61 cutoffs 5-26
sharp edges 7-60 deleting 5-7
amber light excluded replicates 5-32
monitoring supply status 2-4 expired 5-3
status indicator 1-8, 2-4 failed qualitative 5-38
APF failure codes 5-36
see assay protocol file flowchart 5-4
applications last run 5-27
running other 1-15 most recent data 5-27
aspirate and dispense probe manifold 7-35 overview 5-3
poor precision 5-38
aspirate probes
previous active 5-27
10,000 test maintenance 7-32
problems with 5-37
brushing interior 7-42
reagent lot assignment 5-25
cleaning 7-42
running a calibration 5-19
cleaning (flowchart) 7-44
switching 5-32
© 2021 Beckman Coulter, Inc. Index-1

C73199-AA
Index UniCel DxI Operator's Guide
system prompts 5-3 bulk supplies

test requests 5-22 button 1-23
troubleshooting 5-35 consumables 2-3
troubleshooting table 5-37 liquid waste 2-42
types 5-26 overview 2-3
viewing data 5-26, 5-32 RVs 2-37
Assay Manual - Preface-2 screen 2-6
assay protocol file (APF) solid waste 2-49
software overview 1-14 substrate 2-17
system overview 1-2 wash buffer 2-28
waste 2-3
assays
APF 1-2 buttons
assay protocol file 1-2 common window 1-31
calibrations 5-3 comparison 6-5
service 3-35 QC 6-5, 6-9
troubleshooting calibrations 5-37 quality control 6-9
routine processing 3-44
attention
STAT processing 3-48, 3-49
safety statements 1-12
to Help system - Preface-4
auto sample ID 3-34
automatic rerun C
configuring 3-37
calibration curves 5-26
disabling 3-37
low RLUs 5-38
enabling 3-37
troubleshooting flat 5-38
pipettor choice 3-37
viewing data 5-32
calibration cutoffs 5-26
B
viewing data 5-32
B12 assay
calibration data
daily maintenance 7-12
also see assay calibrations
special clean routine 7-17
excluded replicates 5-32
back tab 1-26
most recent 5-27
backups screen 5-28
daily maintenance 7-14 viewing 5-26, 5-32
bar code errors calibration requests
resolving substrate 2-25 changing the reagent lot 5-25
bar code labels entering 5-22
position on tubes 3-40 entering (flowchart) 5-24
reagent pack 2-62 required conditions 5-19
sample container 3-40 screen 5-20
bar codes calibrations
scanning calibrator cards 5-16 assay calibrations 5-3
scanning substrate bottles 2-24 calibrator cards 5-10
batch requests 3-35 scanning 5-16
blue light calibrator levels
status indicator 1-8 editing 5-17
boxes calibrator lots
selecting 1-31 adding 5-12
Index-2 © 2021 Beckman Coulter, Inc.

C73199-AA
deleting 5-18 configurations

expired 5-3 automatic rerun 3-37
calibrators test results screen 4-10
adding (flowchart) 5-15 continuous access 1-2
adding lots 5-12 continuous sample report 4-51
correcting information 5-10 printing 4-60
deleting lots 5-18 controls
editing levels 5-17 see quality control
expired lots 5-10
copy
multi-level 5-10
data entry 1-29
setting up 5-10
copy to disk
setup screen 5-11
QC data 6-42
carryover
result data fields 4-40
maintenance review screen 7-5
test results 4-40
cautions
CRH result flag 4-34
about attention labels 1-12
CRL result flag 4-34
description - Preface-9
radio frequency 1-13 curves
see calibration curves
CCR result flag 4-27
cutoffs
CEX result flag 4-33
see calibration cutoffs
CISPR 11
compliance 1-13
D
clean routines
daily clean system 7-16
cleaning solution warnings 7-17
daily maintenance
clean routines 7-16
requesting maintenance 7-7
log 7-62
running 7-16
overview 7-3, 7-12
cleaning
solid waste 7-15
air filter 7-60
system backup 7-14
test count 7-14
liquid waste container 2-45
data entry
running clean routines 7-16
copy 1-29
sample racks A-3
fields 1-29
wash towers 7-53
paste 1-29
CLT result flag 4-28
dead volumes
CLX result flag 4-34, 5-4
calculations A-5
comments requirements A-5, A-7
assay calibrations 5-33 RVs A-5
patient sample 3-36 sample containers A-5, A-7
QC charts 6-36 system A-5
sample details 4-25
decontaminate
comparison liquid waste container 2-44
button 6-5 liquid waste drawer 7-58
QC charts 6-44 substrate system 7-5

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deflection software overview 1-14

aspirate probes 7-28, 7-39 warranty 1-8
demographics
sample details 4-25 E
DEX result flag 4-34 EIA-232
diluent packs LIS overview 1-14
expiration 4-34 electrical
expiration with LIS 4-36 wearing exposed metal warning 7-23
reagent supplies 2-53 emisions statement
dilution factor radio frequency 1-13
manual entry 3-32 entry methods 1-16
not in work pending 3-15 event log
on reports 4-51 button 1-23
dilution test exceptions
no dilution factor 3-32 sample processing 3-10
QC for onboard dilutions 6-11 expired calibrations 4-34
disks overriding 2-13, 5-3
copying QC data 6-42 processing with 2-13, 5-3
copying test results to 4-40, 4-41 expired sample 3-15
dispense probes expired supplies
10,000 test maintenance 7-45 calibrator lots 5-3, 5-10
electrical warning 7-45 changing substrate 2-18
inspecting 7-45 overriding 2-13
maintenance (flowchart) 7-48 processing with 2-13
positions 7-23, 7-34 reagent packs 2-63
potentially infectious 7-45
EXS result flag 4-34
removing 7-45
external computer 1-15
downloading LIS requests 3-18
duck bill valve F
installing new 7-27
failed calibrations
assay 5-4
removing used 7-23
assay troubleshooting table 5-37
replacing 7-23
troubleshooting 5-35
replacing (flowchart) 7-29
failure codes
wearing exposed metal warning 7-23
assay calibrations 5-36
DxI system
fatal flags 4-27
continuous access 1-2
rerunning cancelled tests 3-37
documentation - Preface-2
installation 1-8 FCC rules
instrument overview 1-3 compliance 1-13
navigation 1-15 fields
overview 1-2 data entry 1-28
random access 1-2 display 1-28
regulatory statements 1-13 list 1-28
regulatory symbols 1-13
safety features 1-9

C73199-AA
filters manual test requests 3-33

assay calibration 5-6 QC test requests 6-25
description 1-29 quality control overview 6-4
laboratory-defined result 4-15 reagent pack deleting 2-76
QC chart and data 6-34 reagent pack loading 2-64
quality control 6-7 reagent pack unloading 2-66
reagent inventory 2-73 reagent pack unloading all 2-69
system-defined result 4-13 RV adding 2-40
test result applying 4-13 sample processing 3-4
test result defaults 4-13 sending results to LIS 4-47
test result defining 4-15 solid waste removal 2-52
test result deleting 4-20 special weekly maintenance 7-20
test result editing 4-15 substrate changing 2-23
test result overview 4-13 test result finding 4-24
work pending 3-21 test result reports 4-59
find function test results overview 4-4
Help system - Preface-8 wash buffer changing 2-34
sample manager 3-12 function buttons
test results 4-22 general function 1-27
flags main menu 1-19
see result flags not available 1-27
flash drive with menu 1-27
copying QC data 6-42
copying test results to 4-40, 4-41 G
flowcharts green light
10,000 test maintenance 7-32 status indicator 1-8
5,000 test maintenance 7-22 GRY result flag 4-34
adding a calibrator lot 5-15
aspirate probe cleaning 7-44 H
aspirate probe installation 7-41 hazard
assay calibrations 5-4 safety symbols 1-9
calibration requests 5-24 Help
comparing QC charts 6-47 System - Preface-2
copying results 4-44 help
daily maintenance 7-13 also see Help system
defining result filters 4-19 button 1-25
deleting manual requests 3-59 technical support - Preface-9
deleting test results 4-49
Help system
dispense probes maintenance 7-48
accessing - Preface-4
duck bill valve replacement 7-29
button bar - Preface-7
editing manual test requests 3-57
description - Preface-4
editing result filters 4-19
exiting - Preface-5
liquid waste removal 2-46
find feature - Preface-8
LIS downloaded requests 3-19
green text links - Preface-6
loading routine racks 3-47
help buttons - Preface-4
loading STAT racks 3-50
link buttons - Preface-5
maintenance overview 7-4
supplies required screen 2-11

C73199-AA
topics window - Preface-8 interlock switches 1-9

using - Preface-4
HIV testing K
special weekly maintenance 7-19 keyboard
host query 3-20 equivalents 1-15
I L
IND result flag 4-28 labels
insert cups also see bar code labels
dead volume requirements A-8 also see safety symbols
in sample tubes 3-43 rack container type A-7
loading 3-43 sample racks A-2
pediatric A-3 laboratory information system (LIS)
preventing air bubbles 3-43 also see LIS
rack container type labels A-8 software overview 1-14
rack sizes A-3 laser safety symbol 1-9
inspections laser warning labels
dispense probes 7-45 location 1-9
fallen RVs electrical warning 7-56 last run calibrations 5-27
for fallen RVs 7-56 LED Safety 1-13
liquid waste drawer 7-58
Levey-Jennings charts 6-33
pump connections at wash buffer
reservoir 7-49 LEX result flag 4-34
reagent pipettors 7-53 lights
upper aspirate peristaltic pump amber status indicator 1-8
connections 7-51 blue status indicator 1-8
wash buffer supply drawer 7-59 green status indicator 1-8
installation red status indicator 1-7
aspirate probes 7-32 liquid waste
duck bill valve 7-27 changing container (flowchart) 2-46
DxI system 1-8 changing full container 2-43
Instructions for Use changing in-use container 2-47
Instrument - Preface-2 disposal 2-44
Instrument in-use container 2-47
Instructions for Use - Preface-2 monitoring levels 2-42
panel icon (DxI 800 only) 2-42
instrument
removal 2-43
supply overview 2-41
DxI 600 illustration 1-4 liquid waste container
DxI 800 illustration 1-3 flushing 2-45
overview 1-3 liquid waste drawer
special weekly maintenance 7-19 inspection 7-58
temperatures 7-5 location 2-41
instrument software potentially infectious 7-58
overview 1-14 LIS

C73199-AA
editing requests at LIS 3-55 utility routine 7-6, 7-7

processing downloads 3-18 Manuals
processing downloads (flowchart) 3-19 Assay Manual - Preface-2
processing overview 3-3 Instrument Instructions for Use -
querying for tests 3-20 Preface-2
sending results manually 4-45 Material Safety Data Sheet - Preface-2
software overview 1-14 Operator’s Guide - Preface-2
work pending 3-15 manuals - Preface-2
load buttons 3-45 Material Safety Data Sheet Manual -
LOW result flag 4-34 Preface-2
LRH result flag 4-35 menu tab 1-26

LRL result flag 4-35 menus
main 1-16
M tab 1-26
main menu modes
function buttons 1-19 system mode descriptions 1-23
menu tab 1-16
software overview 1-16 N
workflow 1-19 NCR result flag 4-29
maintenance non-fatal flags 4-33
10,000 test interval 7-31 not ready mode 1-23
5,000 test interval 7-21
also see maintenance routines O
daily 7-12 onload pusher motion indicator 3-44
daily (flowchart) 7-13
Operator’s Guide - Preface-2
log 7-62
options
overview 7-3
window selections 1-31
overview (flowchart) 7-4
preventive 7-4 ORH result flag 4-35
requesting routines 7-7 ORL result flag 4-35
requests screen 7-10 overdraw of sample A-5
review screen 7-5 OVR result flag 4-36
scheduling 7-14
special weekly 7-19 P
special weekly (flowchart) 7-20 packs
temperature check 7-5 see reagent packs
verification 7-30
padlock icon
maintenance log 7-62 reagent supplies screen 2-65
binder 7-62
password protected
maintenance routines calibrator lot deletion 5-18
clean routines 7-7 control lot deletion 6-19
DxI carryover 7-7 QC data point deletion 6-37
pipettor matching 7-7 test result deletions 4-48
requesting 7-7
paste
run priority 7-10
data entry 1-29
running clean routines 7-16
system check routines 7-7

C73199-AA
patient IDs buttons 6-5, 6-9

manual entry 3-31 calculations 6-28, 6-37
report by 4-51 chart and data filter 6-34
patient samples chart and data screen 6-29
comments 3-36 data collection for ranges 6-50
potentially infections 3-39 data copying 6-42
patient test requests 3-25 data report 6-38
rerunning 4-38 data viewing 6-35
database 6-28
pause
dilution tests 6-11
system command 1-27
establishing ranges 6-50
paused mode 1-23
flags 6-9
peristaltic pump outliers 6-51
connections inspection 7-51 pipettor window 6-17
electrical warning 7-51 problems 6-53
potentially infectious 7-51 processing overview 6-3
upper aspirate 7-51 processing overview (flowchart) 6-4
PEX result flag 4-36 range data evaluation 6-51
pipetting range establishment 6-50
prevent air bubbles 3-43 range protocol 6-50
plus (+) sign reagent lot assignment 6-27
refresh screen 4-9 rerunning a test 6-55
precision pump review report 6-10
connections inspection 7-49 reviewing data overview 6-28
rules 6-8
preventive maintenance 7-4
setup screen 6-12
previous active calibrations 5-27
status indicators 6-9
switching 5-32
test replicates 6-22
processing tests test request editing 6-26
LIS downloaded 3-18 test request entry 6-21
LIS downloaded (flowchart) 3-19 test request entry (flowchart) 6-25
LIS query 3-20 test requests overview 6-20
manual test request entry 3-25 troubleshooting overview 6-53
pump connections troubleshooting results 6-53
at wash buffer reservoir 7-49 Westgard QC rules 6-8
electrical warning 7-49 when to run 6-3
potentially infectious 7-49 QC charts 6-28
precision pump inspection 7-49 comments 6-36
sample pump inspection 7-49 compare charts screen 6-45
upper aspirate peristaltic pump comparing 6-46
inspections 7-51
comparing (flowchart) 6-47
wash pump inspection 7-49
comparison date change 6-48
comparison overview 6-44
Q
data point deletion 6-37
QC data point omission 6-37
also see QC charts data screen 6-29
also see quality control deleting comparisons 6-49

C73199-AA
editing comparison dates 6-48 rack IDs

Levey-Jennings 6-33 changing manually entered 3-60
report 6-38 racks
saving comparisons 6-49 see sample racks
viewing 6-35 radio frequency
viewing comparisons 6-46 cautions 1-13
QCF result flag 4-36 emissions statement 1-13
QEX result flag 4-36 interference 1-13
QNS result flag 4-29 random access 1-2
QSB result flag 4-30 reaction vessels
QSD result flag 4-30 see RVs
QSS result flag 4-31 ready mode 1-23
quality control reagent inventory
also see QC applying a filter 2-73
adding a lot 6-13 deleting packs 2-75
button 1-23, 6-3, 6-9 overview 2-70
comparison button 6-49 report printing 2-77
deleting 6-19 screen 2-71
designating pipettors 6-17 screen filter 2-73
editing a lot 6-13 system tracking 2-70
initial expected values 6-16 reagent load door
list 6-10 unlocking 2-65
material handling 6-50 reagent load tray
material problems 6-54 in-use light 2-65, 2-68
materials 6-20 reagent lots
mean calculation 6-51 assigning for calibrations 5-25
multi-analyte 6-22 assigning for QC 6-27
multi-level set 6-21 calibration 5-19
naming 6-15
reagent packs
pipettors 6-17
also see reagent inventory
screen 6-5
automatic discard 2-70
screen filter 6-7
bar code labels 2-62
SD calculation 6-51
deleting (flowchart) 2-76
setting up lots (overview) 6-11
deleting from inventory 2-75
query details about 2-58
LIS requests 3-20 diluent packs 2-53
Quick Reference Guide empty 2-63, 2-65
Instrument Instructions for Use - expired 2-63
Preface-2
in-use (padlock) icon 2-65
loading 2-60
R loading (flowchart) 2-64
rack exceptions loading area 2-53
button 1-23 loading partial packs 2-64
clearing 3-11 mixing 2-61
resolving errors 3-14 monitoring supplies 2-54
screen view 3-11 partial packs 2-60, 2-64

C73199-AA
potentially infectious 2-53 calibration 5-22

removing all 2-68 LIS download 3-18
report 2-58 LIS query 3-20
storing partial packs 2-66 maintenance 7-8
supply overview 2-53 manual entry 3-30
supply status 2-54 QC 6-21
unloading 2-65 rerunning 4-38
unloading (flowchart) 2-66 rerunning tests
unloading all 2-67 automatically after cancellation 3-25
unloading all (flowchart) 2-69 configuring automatic rerun 3-37
used packs 2-64 patient 4-38
reagent pipettors QC 6-55
designating for controls 6-17 reserve volume
electrical warning 7-53 sufficient sample for A-5
inspection 7-53 result flags
potentially infectious 7-53 corrective actions 4-27
reagent supplies descriptions 4-27
also see reagent packs fatal 4-27
dispense monitoring 2-53 non-fatal 4-33
overview 2-53 QC 6-9
report 2-58 troubleshooting 4-27
screen 2-55 results
red light see test results
status indicator 1-7 resume
refresh screen system command 1-27
test results 4-9 RFX result flag 4-36
regulatory statements RLU result flag 4-31
radio frequency emissions 1-13
routine maintenance 7-3
replicates
running mode 1-23
QC 6-22
RVs
reports
adding 2-38
available 1-31
adding (flowchart) 2-40
calibration 5-9
inspection for fallen 7-56
calibration data 5-34
loading 2-38
continuous sample 4-56
monitoring levels 2-37
heading information 1-33
patient 4-54
partial bags 2-38
QC chart 6-41
potentially infections 7-56
QC data 6-40
supply overview 2-36
QC review 6-10
used for 2-36
reagent inventory 2-78
reagent supplies 2-59
S
sample 4-53
safety features
selected test results 4-55
DxI system 1-9
supplies required 2-15
interlock switches 1-9
test results 4-50
work pending 3-24 safety statements
about attention labels 1-12
requesting tests

C73199-AA
cautions 1-12 sample processing

general 1-12 cancelling manual test requests 3-55
warnings 1-12 deleting samples 3-58
safety symbols deleting samples (flowchart) 3-59
DxI instrument 1-9 deleting test requests 3-58
laser 1-9 editing manual test requests 3-56
sample comments editing requests overview 3-55
patient requests 3-36 editing unscanned racks 3-56
errors 3-14
sample containers
LIS download 3-18
bar code labels 3-40
LIS query 3-20
dead volume requirements A-7
loading routine racks 3-44
matching to racks 3-41
loading STAT racks 3-48
missing 3-15
monitoring progress 3-53
one type per rack A-3, A-4, A-7
overview 3-3
placing in racks 3-41
rack container type labels A-7
status 3-54
rack sizes A-3
troubleshooting patient results 3-61
remove caps 3-41, A-4, A-7
unloading racks 3-50
sample volume required A-5
sample pump
sample details
connections inspection 7-49
troubleshooting 4-25
viewing 4-25 sample racks
window 4-25 cancelling test requests 3-55
changing entered IDs 3-60
sample errors 3-14
cleaning A-3
sample IDs
container type labels A-7
auto sample ID 3-34
labels A-2
manual entry 3-30
loading correctly 3-46
on sample manager screen 3-12
loading overview 3-39
reusing 3-36
loading routine (flowchart) 3-47
sequential assignment 3-34
loading routine samples 3-44
unique 3-36
loading STAT (flowchart) 3-50
sample manager loading STAT samples 3-48
clearing exceptions 3-11 overview A-2
daily view 3-10, 3-11 processing overview 3-39
date for daily view 3-11 rack arms 3-45
exceptions view 3-10 sample container position 3-41
finding sample IDs 3-12 sample containers accepted A-3
in progress view 3-10 sizes A-2
overview 3-3 unloading 3-50
requested view 3-10 unloading overview 3-39
resolving sample errors 3-14
sample report 4-51
screen 3-5
continuous 4-51
screen view selection 3-11
sample status
screen views 3-5, 3-10
descriptions 3-54
test details 3-13
sample tubes
sample pipettor overdraw A-5
with insert cups 3-43
sample presentation unit
see SPU

C73199-AA
sample volume test results 4-4

troubleshooting insufficient 4-29, 4-30, work pending 3-16
4-31
scroll bar 1-26
sample volume calculation A-5 search
saving system files 7-14 see find function
scanning procedures selection methods 1-16
calibrator cards 5-16 on test results screen 4-11
substrate 2-24 service assays 3-35
scheduling maintenance Sodium Azide
by test count 7-14 Safe Handling 2-41
daily 7-12
software
for HIV testing 7-19
installing 1-15
screen elements overview 1-14
back tab 1-26 removing 1-15
common 1-22
solid waste
fields 1-28
biohazard bag 2-51
filters 1-29
changing container 2-50
function buttons 1-27
changing container (flowchart) 2-52
help button 1-25
menu tab 1-26
scroll bar 1-26
sort order 1-29
potentially infectious 2-48, 2-50
status line 1-29
removing 2-50
system command buttons 1-27
reset button 2-52
system modes 1-23
supplies overview 2-48
system status buttons 1-23
solid waste container
screen views
changing 2-50
Help system link button - Preface-6
sample manager 3-10, 3-11
location 2-48
screens potentially infectious 7-15
bulk supplies 2-6
sort order 1-29
calibration 5-5
special clean 7-16
calibration data 5-28
calibrator setup 5-11 special weekly maintenance
common elements 1-22 overview 7-3
maintenance requests 7-11 procedure 7-19
maintenance review 7-5 procedure (flowchart) 7-20
QC chart and data 6-29 SPU
QC setup 6-12 guide rails 3-45
quality control 6-5 offload areas 3-50
reagent inventory 2-71 onload pusher motion indicator 3-44
reagent supplies 2-55 STAT requests
sample manager 3-5 manual entry 3-32
software overview 1-15 status indicators
supplies required 2-11 amber light 1-8, 2-4
test requests 3-26 blue light 1-8
test requests for calibrations 5-20 green light 1-8

C73199-AA
lights 1-7 reagent packs 2-54

QC 6-9 RVs 2-37
red light 1-7 solid waste 2-49
status line 1-29 substrate 2-17
stop supplies required button 2-5
button and status indicator 1-7 system status buttons 2-5
system command 1-27 system status panel (DxI 800 only) 2-4
wash buffer 2-28
substrate 2-24
adding 2-18 symbols
bar code errors 2-25 also see safety or regulatory symbols
changing (flowchart) 2-23 SYS result flag 4-32
changing empty bottle 2-18 system backups
changing expired bottle 2-18 daily maintenance 7-12, 7-14
changing in-use bottle 2-26 system checks
equilibration 2-16 maintenance review screen 7-5
equilibration area 2-22 requesting maintenance 7-7
in-use bottle 2-26 system command buttons
load tray 2-19 descriptions 1-27
monitoring levels 2-16, 2-17
system console
overview 2-16
overview 1-3
system documentation
partial bottles 2-26
cautions - Preface-9
scanning bar code 2-24
Help system - Preface-4
storage 2-16
presentation styles - Preface-3
switching bottles 2-26
warnings - Preface-9
supplies
system mode descriptions 1-23
bulk 2-3
ordering 2-3 system navigation
overview 2-3 enter 1-16
reagent packs 2-53 keyboard equivalents 1-15
RVs 2-37 main menu 1-16
substrate 2-16 overview 1-15
wash buffer 2-27 select 1-16
supplies required system overview

button 1-23 see DxI system
critical instrument conditions 2-11 system status buttons
procedural Help link 2-11 bulk supplies 2-4
report 2-15 colors 1-23
screen 2-11 descriptions 1-23
supply conditions supplies required 2-4
overriding 2-13 supply status 2-5
overview 2-3 system status panel (DxI 800 only)
supply status icons 2-5
amber indicator 2-4 location 2-4
bulk supplies button 2-5 monitoring supply status 2-4
liquid waste 2-42
monitoring 2-4

C73199-AA
verifying system performance 7-30

T
test lists
tabs batch request 3-35
back 1-26
test requests
menu 1-26
auto sample ID 3-34
technical support - Preface-9 batch request 3-35
temperature calibration entry 5-22
nine thermal zones 7-5 cancelling manual requests 3-55
printing report 7-7 comments 3-36
reagent storage flag 4-37 deleting manual requests 3-58
sample wheel troubleshooting 4-37 editing manual requests 3-56
substrate 2-16 editing overview 3-55
troubleshooting incubator 4-32 editing requests (flowchart) 3-57
troubleshooting substrate 4-33 interrupted for STAT 3-49
troubleshooting wash carousel 4-33 LIS download 3-16
test count maintenance 7-7
daily maintenance 7-12 manual entry 3-30
recording 7-14 manual entry (flowchart) 3-33
scheduling maintenance 7-14 monitoring progress 3-53
test details overview 3-25
displaying 3-13 patient 3-25
window 3-13 pending 3-16
processing LIS downloads 3-18
test interval maintenance (10,000)
QC 6-20
air filter 7-60
QC editing 6-26
aspirate probes 7-32
QC entering 6-21
dispense probes 7-45, 7-48
querying the LIS 3-20
inspecting for RVs 7-56
reagent lot for calibrations 5-25
installing clean aspirate probes
(flowchart) 7-41 reagent lots for QC 6-27
liquid waste inspection 7-58 reusing sample IDs 3-36
log 7-62 sample information 3-25
overview 7-31 screen 3-26
overview (flowchart) 7-32 STAT entry 3-32
pump connections at wash buffer test status 3-54
reservoir 7-49 test result filters
reagent pipettors 7-53 applying 4-13
upper aspirate peristaltic pump defining 4-15
connections 7-51 deleting 4-20
verifying system performance 7-30 edit filter window 4-16
wash buffer inspection 7-59 editing 4-15
wash towers 7-53 filter window 4-14
test interval maintenance (5,000) flowchart 4-19
duck bill valve (flowchart) 7-29 overview 4-13
duck bill valve replacement 7-23 test results
log 7-62 also see test result filters
overview 7-21 configuring screen 4-10
overview (flowchart) 7-22 copying 4-40

C73199-AA
copying (flowchart) 4-44 reports 1-31

deleting 4-48 screens 1-15
deleting (flowchart) 4-49 system modes 1-23
finding 4-22 windows 1-15
finding (flowchart) 4-24 UniCel system
flags 4-27 see DxI system
managing 4-39 unload all packs 2-67
USB ports 4-41
printing (flowchart) 4-59
user interface (UI)
printing continuous sample report 4-60
see UI software
printing reports 4-57
refreshing screen 4-9 utility routine
report descriptions 4-51 disabling 7-7
reports 4-50 enabling 7-7
rerunning tests 4-38 maintenance review screen 7-5
reviewing (overview) 4-21 overview 7-3
sample details 4-25 running manually 7-6
screen 4-4
screen report 4-51 V
selection 4-11 verification
sending to LIS 4-45 aspirate probe deflection 7-28, 7-39
sending to LIS (flowchart) 4-47 LIS results column 4-10
storing 4-39 sending LIS results 4-45
troubleshooting flags 4-27 system performance 7-30
troubleshooting variability 3-64 vessel hopper
test status descriptions 3-54 adding RVs 2-38
thermal zones 7-5 clearing fallen RVs beneath 7-57
location 2-36
TRA result flag 4-37
TRI result flag 4-32
W
troubleshooting
warning labels
assay calibrations 5-37
laser 1-9
patient sample results 3-61
Warnings
QC results 6-53
Sodium Azide 2-41
result variability 3-64
sample details 4-25 warnings
test result flags 4-27 about attention labels 1-12
unexpected sample results 3-62 description - Preface-9
TRR result flag 4-37 warranty

DxI system 1-8
TRS result flag 4-33
wash buffer
TRW result flag 4-33
adding 2-29
changing (flowchart) 2-34
U
changing empty container 2-29
UI software
changing in-use 2-35
common screen elements 1-22
in-use container 2-35
common window elements 1-30
location 2-27
navigation 1-15
overview 1-14

C73199-AA
overview 2-27 print (test results) 4-58

panel icons (DxI 800 only) 2-28 QC pipettor 6-17
supply drawer inspection 7-59 request calibration 5-22
switching 2-35 request maintenance 7-9
wash buffer reservoir request QC 6-21
pump connection inspection 7-49 sample details 4-25
wash pump send to LIS 4-46
connections inspection 7-49 software overview 1-15
substrate bar code scan error 2-25
wash towers
test details 3-13
cleaning 7-53
unload all packs 2-67
electrical warning 7-53
location 7-53, 7-54, 7-55 work pending
overflow reservoirs 7-55 button 1-23
potentially infectious 7-53 deleting tests 3-22
expired sample 3-15
waste
filter 3-21
bulk 2-3
missing sample 3-15
liquid 2-41
no dilution factors 3-15
solid 2-48
obstruction detected 3-16
weekly maintenance 7-19
overview 3-15
Westgard QC rules 6-8 printing 3-23
Levey-Jennings chart 6-33 report 3-23
window elements rerunning patient tests 4-38
boxes 1-31 rerunning QC 6-55
common 1-30 screen 3-16
common buttons 1-31
information fields 1-28
options 1-31
windows
add calibrator 5-13
add control 6-14
calibration filter 5-6
common elements 1-30
configure screen (test results) 4-10
copy to disk (test results) 4-41
delete (work pending) 3-23
edit control 6-14
edit date range (QC comparison) 6-48
edit filter (test results) 4-16
filter (QC chart and data) 6-34
filter (quality control) 6-7
filter (reagent inventory) 2-74
filter (test results) 4-14
filter (work pending) 3-21
find (test results) 4-22
help topics - Preface-8
options (work pending) 3-38
print (QC chart and data) 6-38

C73199-AA

Unicel DxI Operator's Guide

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Operator's Guide

Changes to this Revision

This manual is intended for use with:

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

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

© 2020 Beckman Coulter, Inc. i

3 Sample Manager . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

4 Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

5 Assay Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

6 Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

ii © 2020 Beckman Coulter, Inc.

7 Routine Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

A Sample Racks and Containers . . . . . . . . . . . . . . . . . . . . . . . A-1

© 2020 Beckman Coulter, Inc. iii

iv © 2020 Beckman Coulter, Inc.

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

Using the Help System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface-4

Notes, Cautions, and Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface-9

Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface-9

© 2021 Beckman Coulter, Inc. Preface-1

Preface-2 © 2021 Beckman Coulter, Inc.

Required and Optional Procedure Steps

© 2021 Beckman Coulter, Inc. Preface-3

Operator's Provides the step-by-step information needed for

Table 1 Help System Book Descriptions

Accessing the Help System

Table 2 System Software Help Button Descriptions

Preface-4 © 2021 Beckman Coulter, Inc.

Table 2 System Software Help Button Descriptions (continued)

Exiting the Help System

Help System Link Buttons

(Arrow button) Select to display a related topic.

Table 3 Help System Link Button Descriptions

(View Screen or View Window button) Select to display an

(Example button) Select to display an example of a concept referred

(Glossary button) Select to display the definition of a glossary term.

Table 3 Help System Link Button Descriptions (continued)

Help Text Highlighted in Green

Preface-6 © 2021 Beckman Coulter, Inc.

Help Button Bar

Figure 4 Help Button Bar Descriptions

© 2021 Beckman Coulter, Inc. Preface-7

Help Topics Window

Figure 5 Help Topics Window (Contents View) Descriptions

Help Find Feature

Preface-8 © 2021 Beckman Coulter, Inc.

Notes highlight or provide additional information.

Cautions emphasize the possibility of damage to the

Warnings emphasize the possibility of harm to a

Table 6 Notes, Cautions, and Warnings

© 2021 Beckman Coulter, Inc. Preface-9

Preface-10 © 2021 Beckman Coulter, Inc.

1.2 Instrument Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

Status Indicator Lights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

Safety Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

Safety Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

Laser Warning Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

Safety Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12

Regulatory Symbols and Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13

Other Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13