Beckman Coulter UniCel DxI System Owner's Manual

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Beckman Coulter UniCel DxI System Owner's Manual | Manualzz

Operator's Guide

C95317-AA

December 2022

Printed in U.S.A.

© 2022 Beckman Coulter, Inc. All rights reserved.

Beckman Coulter, Inc. • 250 S. Kraemer Blvd. • Brea, CA 92821 • U.S.A.

https://www.beckmancoulter.com

Publication Notes

This manual, C95317-AA, release date 2022-12, supports:

• UniCel DxI published system software version 5, including full versions 5.1, 5.2, 5.3.0, 5.3.1, 5.5.0,

5.6.0, and 5.7.0.

• UniCel DxI published system software version 7, including full version 7.0.0.

Changes to this Revision

Chapter Page Change Description

Publication Notes Publication Notes Added software version 7.0.0.

Revision History:

C88926-AA, October 2022

C84133-AA, April 2022

C73199-AA, March 2021

C48057-AA, August 2020

C38351-AB, March 2019

C38351, January 2019

UniCel DxI software versions 5.1, 5.2, 5.3.0, 5.3.1, 5.5.0, 5.6.0, and 5.7.0

UniCel DxI software versions 5.1, 5.2, 5.3.0, 5.3.1, 5.5.0, 5.6.0, and 5.7.0

UniCel DxI software versions 5.1, 5.2, 5.3.0, 5.3.1, 5.5.0, 5.6.0, and 5.7.0

UniCel DxI software versions 5.1, 5.2, 5.3.0, 5.3.1, 5.5.0, and 5.6.0

UniCel DxI software versions 5.1, 5.2, 5.3.0, 5.3.1, and 5.5.0

UniCel DxI software versions 5.1, 5.2, 5.3.0, 5.3.1, and 5.5.0

This manual is intended for use with:

• The UniCel DxI 800 Access Immunoassay System

• The UniCel DxI 600 Access Immunoassay System.

This guide also can be used as supplemental material for the UniCel DxC 880i, 860i, 680i, and 660i Synchron

Access Clinical System Integrated Workstations. Not all instructions in this manual are applicable to the UniCel

DxC Synchron Access Integrated Workstation running in integrated mode. Refer to the UniCel DxC Synchron

Access Integrated Workstation Instructions for Use manual.

Beckman Coulter, Inc. grants a limited non-exclusive license to the UniCel DxI system owner or operator to make a copy of all or a portion of this book solely for laboratory use.

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

Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries.

ProClin™ is a trademark of The Dow Chemical Company ("Dow") or an affiliated company of Dow.

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 ii

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

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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

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Table of Contents UniCel DxI Operator's Guide iv © 2022 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

© 2022 Beckman Coulter, Inc.

C95317-AA

Preface-1

Preface

About This

Manual

UniCel DxI Operator's Guide

This UniCel DxI Operator's Guide provides the same content delivered in the Help 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

System

Documentation

The UniCel DxI system includes the following documentation.

• The UniCel DxI Help system, which provides detailed operating and 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 © 2022 Beckman Coulter, Inc.

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UniCel DxI Operator's Guide

Using the

Manual

Preface

To make information easier for you to locate within a procedure or topic, UniCel DxI 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: Running Ready Not Ready

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Preface UniCel DxI Operator's Guide

The Help

System

The UniCel DxI Help system provides context sensitive assistance for using the 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

Procedures Book

Reference

Information Book

Illustration Books

*

*

*

Provides the step-by-step information needed for everyday operation of the UniCel DxI system.

Provides background, theory, system setup, and advanced maintenance information for the UniCel DxI system.

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

Help System

Preface-4

You can access the Help system from most screens and windows in the UniCel DxI 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

Buttons

Description

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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UniCel DxI Operator's Guide Preface

Help

Buttons

Description

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.

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( 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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Preface UniCel DxI Operator's Guide

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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UniCel DxI Operator's Guide Preface

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.

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Help Window Menu

(Do Not Use)

Find

Help Topics

Back

Print

Glossary

Exit

2167A.bmp

The Help window menu contains features that can 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.

(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.

(Button) Displays the Contents view of the Help Topics

window. For more information, see the Help Topics

Window topic.

(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.

(Button) Select to print the displayed topic.

(Button) Select to display the Help system glossary.

This button is available only in some Help windows.

(Button) Select to exit the Help system.

Figure 4 Help Button Bar Descriptions

Preface-7

Preface UniCel DxI Operator's Guide

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.

Preface-8

Contents

Index

Find

2168A.bmp

(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.

(Tab) Select to locate information by typing the first few letters of a word, and then by selecting one of the available topics.

(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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UniCel DxI Operator's Guide Preface

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,

Cautions, and

Warnings

System documentation uses notes, cautions, and warnings to draw your attention to important information, instrument operation instructions, and safety information.

Graphic and Text Description

Notes highlight or provide additional information.

NOTE

CAUTION

Cautions emphasize the possibility of damage to the instrument.

WARNING

Warnings emphasize the possibility of harm to a person, either to the operator or to a patient because of the possibility of erroneous results.

Table 6 Notes, Cautions, and Warnings

Technical

Support

For technical assistance with the UniCel DxI Access Immunoassay System:

• In the U.S.A. or Canada, contact Beckman Coulter Technical Support by phone at 1-800-854-3633 or online at www.beckmancoulter.com. Before using online support the first time, you will need to register online.

• Outside the U.S.A. and Canada, contact your technical support representative.

NOTE

Be prepared to provide your system ID.

© 2022 Beckman Coulter, Inc.

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Preface UniCel DxI Operator's Guide

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UniCel DxI Operator's Guide 1: System Overview

© 2022 Beckman Coulter, Inc.

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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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12

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

1-1

1: System Overview UniCel DxI Operator's Guide

1.1 System Overview

FOR PROFESSIONAL USE ONLY

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 .

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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.

21

7

1

20

8

2

3

19

9

11

10

18

12

6

5

4

13

14

16

15

17

1

3

5

Touchscreen monitor

Mouse

Printer

7 Right main upper cover

9 Substrate load area

11 System status panel (if equipped)

13 Substrate bar code reader

15 Wash buffer supply drawer

17 Liquid waste drawer (optional)

19 Side offload area

21 Left main upper cover

2 Keyboard

4 PC bar code reader

6 External computer

8 Status indicator lights

10 Reagent load/unload area

12 STAT / Routine buttons

14 Lower right door and instrument power switch (behind door)

16 Solid waste door

18 Sample presentation unit (SPU)

20 Vessel hopper door

Figure 1-1 UniCel DxI 800 Instrument and System Console

2055A.eps

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19

7

1

18

8

2

3

9 10

17

11

12

13

15

14

16

1 Touchscreen monitor

3 Mouse

5 Printer

7 Right main upper cover

9 Substrate load area (hidden in picture)

11 STAT / Routine buttons

13 Lower right door and instrument power switch (behind door)

15 Solid waste door

17 Sample presentation unit (SPU)

19 Left main upper cover

2

4

6

8

10

12

14

16

18

Keyboard

PC bar code reader

External computer

Status indicator lights

Reagent load/unload area

Substrate bar code reader

Wash buffer supply drawer

Liquid waste drawer (optional)

Vessel hopper door

Figure 1-2 UniCel DxI 600 Instrument and System Console

6

5

4

2055B.eps

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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 (if equipped) - 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

Indicator

Lights

1.2: Instrument Overview

The four status indicator lights are arranged vertically on the front panel of the instrument. The Red , Green , and Blue indicator lights designate a specific instrument operating mode. The Amber indicator light informs you when a supply level requires your attention.

3

4

1

2

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 (if equipped) 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.

Off

Indicator State

Lit -

Solid light

Lit -

Blinking light

Description

The supply levels are sufficient.

One or more system supplies are low or the waste containers are almost full. The system continues to process tests and schedule new tests.

System supplies are out, or an area requires 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

Warranty

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.

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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Safety

Features

Safety

Symbols

1.2: Instrument Overview

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.

The UniCel DxI Access Immunoassay System is designed to meet U.S. and international safety standards. Safety labels are affixed to the instrument to alert you to safety considerations. Interlock switches stop the movement of the pipettors and robotic modules to protect you from injury if you open the instrument covers while the system is running.

Interlock Switches

The UniCel DxI system is equipped with interlock switches to protect you from injury. If you open the covers of the instrument, the interlock switches stop all moving parts. If you open the covers while the system is processing samples, the system cancels all tests in progress.

Certain areas of the UniCel DxI instrument present a risk of personal injury or damage to the instrument if proper safety procedures are not followed. These areas are marked with one or more safety symbols to identify the hazard. These symbols are defined in the Access Immunoassay Systems Symbol Glossary , available at techdocs.beckmancoulter.com.

Laser Symbol

The laser symbol indicates areas of the instrument where laser light is used. Do not stare into the laser beam.

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.

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1

2368A.eps

This label is attached to the SPU bar code reader and the reagent storage bar code reader.

AVOID EXPOSURE LASER LIGHT IS EMITTED

FROM THIS APERTURE

CAUTION

VORSICHT

LASER RADIATION

DO NOT STARE INTO BEAM

CLASS 2 LASER PRODUCT

670nm 1.0mW 101~186µs

LASERSTRAHLUNG, NICHT IN DEN

LICHTSTRAHL BLICKEN. SICHTBARE

LASERSTRAHLUNG.

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.

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3

&

2371A.eps

Figure 1-6 Laser Warning Label Placement Behind the UniCel DxI Sample

Processing Unit (SPU)

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2372A.eps

1

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

Statements

The following statements describe general safety concerns and provide information about attention symbols with no accompanying text.

WARNINGS

• The UniCel DxI instrument has moving parts 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.

Regulatory

Symbols and

Statements

The UniCel DxI Access Immunoassay System meets the requirements of a variety of domestic and international regulatory agencies, standards, and directives. This compliance is indicated by symbols and marks on the instrument. These symbols are defined in the Access Immunoassay Systems Symbol Glossary , available at techdocs.beckmancoulter.com.

Notice to User

For a patient/user/third party in the European Union and in countries with identical regulatory regime (Regulation 2017/746/EU or In vitro Diagnostic Medical Devices): if, during the use of this device or as a result of its use, a serious incident has occurred, please report it to the manufacturer and/or its authorized representative and to your national authority.

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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

Symbols

In addition to safety and regulatory symbols, other symbols are placed on the instrument to identify functional elements such as network jacks and the air filter.

These symbols are defined in the Access Immunoassay Systems Symbol Glossary, available at techdocs.beckmancoulter.com.

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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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Running

Other

Applications

Only the UniCel DxI system software should be installed on the external computer.

Do not install or remove any software except as directed by a Beckman Coulter technical support representative.

Do not use the external computer to view documentation other than the system Help .

Screens and

Windows

The UI is organized by function into a set of screens that have common elements.

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

Navigation

The UniCel DxI system provides three navigation methods that you can use in any 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

Perform the indicated function or display the indicated screen

Go to the Main Menu

Display the Supplies Required screen

Resume sample processing

Display the Help system

Go back to the previous screen

Display a list in a field

Pause the system

Keyboard Equivalent

[F1] - [F8]

[F9]

[F10]

[F11]

[F12]

[Esc]

[Down Arrow]

[Pause]

Table 1-8 Keyboard Equivalents

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Action

Stop the system

Print a screen or window

Display the Event Log

Keyboard Equivalent

[Shift]-[Pause]

[Print Screen]

[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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Sample Manager

F1

Select to display the Sample Manager screen. Use this screen to:

• 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.

2001C.bmp

Figure 1-9 Main Menu Descriptions

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Test Results

F2

Supplies

F3

Quality Control

F4

Calibration

F5

Maintenance Review

F6

Select to display the Test Results screen. Use this screen to:

• 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.

Select to display the Supplies menu. Use this menu to:

• 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.

Select to display the Quality Control screen. Use this screen to:

• 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.

Select to display the Calibration screen. Use this screen to:

• Add, edit, and delete calibrators

• View calibration data

• Print calibration reports

For more information, see Chapter 5: Assay Calibration.

Select to display the Maintenance Review screen. Use this screen to:

• 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

F7

Configure

F8

Select to display the Diagnostics menu. Use this menu to:

• 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 .

Select to display the Configure menu. Use this menu to:

• 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

Workflow

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

For an illustration of the workflow for each of the Main Menu function buttons, see

Figure 1-10.

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1-20

Sample Manager

F1

Test Results

F2

Supplies

F3

Quality Control

F4

Calibration

F5

F1 Views

F1 In Progress

F2 Requested

F3 Daily

F4 Exceptions

F2 Edit Request (Requested and Daily views)

Clear Exceptions (Exceptions view)

F3 New Request

F1 Patient/QC Requests

F2 Calibration

F3 Maintenance

F4 Test Results

F5 Work Pending

F6 Find

F8 Details

F1

F2

F6

F7

Filter

Sample Manager

Delete

Print

F8 Options

F1 Filter

F2 Find

F3 Rerun Test

F4 Sample Details

F5 Send to LIS

F6 Copy to Disk

F7 Print

F8 More Options

F1 Report

F2 Completed Samples

F1 Refresh Screen

F2 Configure Screen

F3 Delete Data

F1 Bulk Supplies

F1 Reagent Supplies

F3 Change In-Use Bottle

F8 Reagent Inventory

F2 Reagent Supplies

F1 Bulk Supplies

F2 Unload Reagent Packs

F3 Unload All Reagent Packs

F6 Details

F7 Print

F8 Reagent Inventory

F1 Filter

F2 Review Chart

and Data

F1 Filter

F5 Delete Point

F6 Copy to Disk

F7 Print

F1 Rack ID

F2 Delete Sample

F3 New Request

F4 Test Results

F5 Request QC

F6 Cancel Request

F7 Clear All Samples

F8 More Options

F1 Rack ID

F3 New Request

F4 Test Results (N/A for

maintenance requests)

F6 Cancel Request

F1 Substrate

F2 Liquid Waste

F3 Wash Buffer

F1 Reagent Supplies

F2 Unload Reagent Pack

F5 Delete Pack

F7 Print

F8 Filter

F3 Compare Charts

F4 Delete Comparison

F5 QC Setup

F7 Print

F1 Filter

F2 Review Data

F5 Calibrator Setup

F6 Delete

F7 Print

F1 Save Comparison

F2 Review Chart and Data

F4 Edit Date Range

F1 Add Control

F2 Edit Control

F6 Delete Control

F1 Select Curve/Limits

F2 Switch Active Curve

F3 Comment

F7 Print

F1 Add Calibrator

F2 Edit Calibrator

F6 Delete Calibrator

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

F1 Chart 1

F2 Chart 2

F3 Chart 3

F1 Active

F2 Previous Active

F3 Last Run

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1.3: Software Overview

Maintenance Review

F6

Diagnostics

F7

Configure

F8

F1 Pipettor Matching

F2 System Checks

F3 Carryover

F4 Decontaminate

Substrate

F5 Run Utility Routine

F6 Enable/Disable

Utility Routine

F7 Print

F1

F2

F3

F1

F2

F3

F4

F5

F6

F7

F8

Initialize System

Prime Fluidics

Subsystem

Diagnostics

F4 Device Diagnostics

F5 LIS/LAS

F6 Save Data

F7 Diagnostic Reports

F8 Unlock SPU

System Setup

Tests

Test Panels

Derived Results

Reflex Tests

LIS/LAS

PC Admin

About DxI 800

or DxI 600

F1

F2

Reag. Pipettor Matching

Low Volume Matching

F1 RV Feeder

F2 RV Mixer

F3 Pick and Places

F4 Reagent Storage

F5 Volume Checks

F1

F2

F3

Mechanics

Digital Devices

F4

F5

F6

F7

F1

F2

Analog Devices

Luminometer

Ultrasonics

Exerciser

RF Level Sense

Copy to Disk

Export Logs

F1 Home All

F2 Alignments

F1

F2

Analog Data

Sensor Calibration

F1 Pressure

F2 Wash Buffer

F3 Liquid Waste

F4 Wash Buffer Flow

F1 Read

F2 Load/Read Vessel

F3 Save LED Reading

F4 Save High Voltage

Control

F5 Dark Count Check

F8 Cancel

F1 Panel Lights

F2 Peristaltic and

Vacuum Pumps

F3

F4

Digital Inputs

Digital Outputs

F1 Ultrasonic Settings

F2 Ultrasonics Adjustments

F1 SPU

F2 LAS

F1

F2

LIS

LAS

F1 LIS Setup

F3 Loopback Check

F4 Query for

Test Requests

F6 Copy to Disk

F8 Clear Screen

F1 Filter

F2 Edit Units

F3 Ranges

F4 Gray Zone

F5 Special

F6 Assign Pipettor

F7 Print

F8 Update APF

F1 System Revisions

F2 Bar Code

Reader Setup

F3

F5

F6

F7

F8

Set Workgroup

Date/Time

Password Setup

Supplies Setup

Reports Setup

Rack ID Setup

F3 Ranges

F4 Add Derived

Result

F5 Edit Derived

Result

F6 Delete

F7 Print

F1 Filter

F4 Add Panel

F5

F6

F7

Edit Panel

Delete Panel

Print

F1 Scheduled Backup

F2 Immediate Backup

F3 Eject Tape

F4 Restore

F5 Auto-Delete Setup

F6 Reset Verbosity

F7 Database Maintenance

F8 System Admin

F2 Rack ID Setup

F3 Reserve Volume Setup

F4 Add Reflex Test

F5 Edit Reflex Test

F6 Delete

F7 Print

F8 More Options

F1

F2

F1

F2

DxI Reserve

LAS Reserve

Enable All

Disable All

F1 Shut Down PC

F2 Shut Down Instrument

F3 Instrument Service

F4 Remote Management

F5 Integrated System Setup

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

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1.3: Software Overview

Common

Screen

Elements

UniCel DxI Operator's Guide

The UniCel DxI system displays certain elements on every screen so you can continuously monitor the system status. The labels in the example screen are described in the topics that follow.

1-22

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.

The system is ready to begin processing samples. SPU operations such as aliquoting of samples can take place while in the Ready mode.

The system is performing a function, such as processing samples or running a maintenance routine.

No new tests are scheduled, but currently scheduled tests continue processing.

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

Button

Rack Exceptions

Description Button Colors

Select to display the Exceptions view of the Sample Manager screen. For more

information, see the Sample Manager

Screen Views topic in Section 3.1:

Sample Manager Overview.

Yellow

One or more sample containers has an error associated with it. For more

information, see Section 3.7: Patient

Sample Troubleshooting.

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Table 1-14 System Status Buttons

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1.3: Software Overview UniCel DxI Operator's Guide

System Status

Button

Work Pending

Description Button Colors

Select to display the Work Pending screen for information about test requests that the system cannot schedule. For more information,

see Chapter 3: Sample Manager.

Yellow

A test request cannot be processed because a sample is required.

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Supplies Required Select to display the Supplies Required screen for information about needed supplies or calibrations. For more

information, see Chapter 2: Supplies.

2009A.bmp

Yellow

The system requires supplies or calibration to complete the requested tests.

Red

The system cannot start tests until the underlying instrument condition has been resolved. Certain conditions provide a Help button in the Status column that link directly to the corresponding Help procedure topic for rectifying the condition.

Bulk Supplies

2007A.bmp

Select to display the Bulk Supplies screen for information on the available quantities of substrate, wash buffer and

RVs, and the available space in the solid waste container and in the bulk liquid waste container. For more

information, see Chapter 2: Supplies.

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.

Yellow

A supply is low or near expiration, or a waste container is nearly full. The needle on the gauge is displayed near the left end of the scale.

Red

A supply is empty or expired, or a waste container is full. The needle on the gauge is displayed all the way to the left.

Table 1-14 System Status Buttons (continued)

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UniCel DxI Operator's Guide 1.3: Software Overview

System Status

Button

Quality Control

Event Log

Description Button Colors

Select to display the Quality Control screen to setup quality controls, or review quality control results. For more

information, see Chapter 6: Quality

Control.

Red

A quality control result is not within the acceptable range of expected values.

2010A.bmp

2012A.bmp

Select to display the Event Log screen for information about events generated by the system. From this screen you can display troubleshooting information about caution or warning events. For more information, see Chapter 5: Event

Log in the Reference Manual .

Yellow

The system has generated a caution event indicating a condition that requires your attention soon.

Red

The system has generated a warning 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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1.3: Software Overview UniCel DxI Operator's Guide

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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UniCel DxI Operator's Guide 1.3: Software Overview

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.

2136A.bmp

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.

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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.

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Table 1-20 Function Button Examples

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1.3: Software Overview UniCel DxI Operator's Guide

Function Button Description

A button without a label is not a function button. If you select it, the system does not respond.

0812A.bmp

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.

Display Field

0814A.bmp

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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UniCel DxI Operator's Guide

List Field

1.3: Software Overview

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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1.3: Software Overview

Common

Window

Elements

UniCel DxI Operator's Guide

The UniCel DxI system windows provide information, or prompt you to enter information, to perform an action, or to confirm that you want the system to perform an action. Illustrations of many windows are included in the system documentation.

1-30

Op

Options

Boxes

OK

F1 or

Done

F1

Cancel

F8

Help

F12

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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 are aggregate selections. Any number of boxes can be selected at the same time.

Select to:

• Save and apply changes and exit the window

• Confirm that you want an action to be performed

• Exit a window

Select to exit a window without performing the task.

If you have changed selections in the window, the changes are not saved or applied.

Select to:

• 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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UniCel DxI Operator's Guide 1.3: Software Overview

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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1.3: Software Overview UniCel DxI Operator's Guide

• 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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UniCel DxI Operator's Guide 1.3: Software Overview

3

4

Report Name

UniCel DxI 800, Access Immunoassay System

S/N 654321, Version 4.4

Laboratories, Inc.

Laboratory A

123 Lake Street

Townsville, ST 3333

101-555-2323 ext. 109

1

2

5

6

7

8

Jane Smith

9

10

QNS = sample quantity not sufficient, ORL = result below reference range, ORH = result above reference range,

LEX = reagent pack lot expired

13 12

11

Technologist

Page 1 of 1

Printed 02/03/11 02:43 PM

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

3006B.eps

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2: Supplies UniCel DxI Operator's Guide

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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

Supply Status

The system displays and continuously updates its supply and operating status during processing. Three different system indicators present the supply information:

• The Amber status indicator light

• The system status panel (if equipped)

• 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 (if equipped) 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 -

Solid light

One or more system supplies are low or the waste containers are almost full. The system continues to process tests and schedule new tests.

Lit -

Blinking light

System supplies are out, or an area requires attention. The system attempts to complete any tests in progress, but does not schedule new tests.

Table 2-1 Amber Indicator Light Descriptions

System Status Panel (UniCel DxI 800 only; not all systems are equipped)

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

Bulk Supplies

Screen

Use the Bulk Supplies screen to:

• 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

Substrate: Status

2026A.bmp

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

Substrate: Status

(continued)

Substrate: Tests

Left

Substrate: Lot

Number

Status

(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 .

Tests 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.

Lot 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.

Substrate: Bar

Code

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.

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

Substrate: Days to

Expiration

Days to 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.

Wash Buffer:

Status

Wash Buffer:

Estimated % Full

NOTE

If a substrate bottle is disabled, this field will not turn yellow or red until the bottle is enabled.

Bulk Wash Buffer Containers

(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 .

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.

Figure 2-3 Bulk Supplies Screen Descriptions (continued)

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

RV Supply

Liquid Waste:

Status

(for systems using on-board bulk liquid waste containers)

Liquid Waste:

Estimated %

Empty

(for systems using on-board bulk liquid waste containers)

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.

Bulk Liquid Waste Containers

(Icon) Displays the liquid waste level in the two on-board liquid waste positions.

As the level of liquid waste in the in-use container increases, the level displayed in the corresponding icon also increases.

Status

(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 .

Estimated % Empty

(Field) Displays a percentage estimate of the available space in the on-board bulk liquid waste containers.

• This field turns yellow if one of the on-board containers is almost full.

• This field turns red when all on-board containers are full. If there is only one on-board container, the field turns red when the container has 9% of its volume available for collecting waste.

Figure 2-3 Bulk Supplies Screen Descriptions (continued)

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

Solid Waste

Reagent Supplies

F1

Change In-Use

Bottle

F3

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.

(Button) Select to display the Reagent Supplies screen. For more information, see

Section 2.7: Reagent Supplies.

(Button) Select to display a menu with the following options:

Substrate F1

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.

Reagent Inventory

F8

NOTE

If you cannot change the in-use bottle for any of the three reagents, its button is not available.

(Button) Select to display the Reagent Inventory screen. For more information, see

Section 2.8: Reagent Inventory.

Figure 2-3 Bulk Supplies Screen Descriptions (continued)

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UniCel DxI Operator's Guide

Supplies

Required

Screen

2.1: Supply and Supply Conditions Overview

The Supplies Required screen lists the supplies or calibrations required to complete your test requests. Use this screen to:

• 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

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

Required

Supply

Lot Number

Status

Reagent Supplies

F1

Reagent Inventory

F2

Print

F7

Override

F8

(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.

(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.

(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.

(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.

(Button) Select to display the Reagent Supplies screen. For more information, see

Section 2.7: Reagent Supplies.

(Button) Select to display the Reagent Inventory screen. For more information, see

Section 2.8: Reagent Inventory.

(Button) Select to print the Supplies Required Report. For more information, see the Printing the Supplies Required Report procedure.

(Button) Select to continue sample processing with all of the expired supplies and 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)

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

Overriding

Supply

Conditions

You can start sample processing using expired calibrations, substrate, reagent packs, or reagent lots, and diluent packs or lots by overriding the current conditions. The 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.

System Mode:

1.

Running Paused

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.

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2.1: Supply and Supply Conditions Overview

Resolving

Supplies

Required

Conditions

UniCel DxI Operator's Guide

Use this procedure as general guidance for correcting conditions displayed on the

Supplies Required screen.

The most critical instrument check conditions are listed toward the top of the table 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.

3.

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.

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).

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

Printing the

Supplies

Required

Report

The Supplies Required report is a printout of the entries on the Supplies Required screen. To print a copy of the report, select Print F7 on the Supplies Required screen.

System Mode: Any Mode

Supplies Required Report

UniCel DxI 800, Access Immunoassay System

S/N 654321, Version 4.4

Laboratories, Inc.

Laboratory A

123 Lake Street

Townsville, ST 33333

101-555-2323 ext. 109 Jane Smith

Racks to be Scanned: 0

Required

No Racks to Process

Initialize System

Prime Fluidics

Supply

Bulk Feeder Disabled

Wash Buffer Bubble Detector

Enable or Configure Pipettor Pipettor #1

Change Substrate

Load 1 Pack

Recalibrate

Calibrate

Fill

AFP

TotT3

Ferritin

RV Supply

Empty

Empty

Change

Solid Waste

Liquid Waste

Wash Buffer

Lot Number

990804

100220

Status

Calibration Expired

No Calibration

Technologist ____________________

Page 1 of 1

Printed 02/08/11 04:03 PM

Figure 2-5 Supplies Required Report Example

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2.2: Substrate UniCel DxI Operator's Guide

2-16

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 Amber status indicator light

• The system status panel (if equipped)

• The Bulk Supplies button

• The Bulk Supplies screen

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UniCel DxI Operator's Guide 2.2: Substrate

Monitoring the Substrate

Supply

The following table summarizes the different methods available to monitor substrate supply conditions.

• Amber

status indicator light (see Figure 1-3 in Section 1.2: Instrument

Overview)

• Substrate

panel icon (if equipped - 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 responding in each of these ways:

• The Amber status indicator light is lit

• One of the Substrate panel icons is lit (if equipped)

• The Bulk Supplies button turns yellow

• On the Bulk Supplies screen, the

Substrate Status for a bottle is

Empty or Not Present, or the Tests

Left field turns yellow

• The Amber status indicator light blinks

• Both of the Substrate panel icons blink (if equipped)

• 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

Then one or more of these substrate supply conditions exist:

• A lot expires in three days or sooner

• An open bottle expires in three days or sooner

• One of the on-board bottles is empty

• There is only one on-board bottle, and it has fewer than 60 tests left

• One bottle is not present, or is not recognized by the system

• All lots are expired

• All open bottles are expired

• All on-board bottles are empty

• No bottles are present, or are not recognized by the system

Table 2-6 Monitoring Substrate Supply

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2.2: Substrate UniCel DxI Operator's Guide

Changing an

Empty or

Expired

Substrate

Bottle

If there is a sufficient substrate supply, the system continues to process tests while you change the empty or expired bottle. To change a bottle before it is empty or expired,

see the Changing an In-Use Substrate Bottle procedure.

Use this procedure to change an empty or expired substrate bottle.

System Mode: Any Mode

1.

Check the substrate status to determine how many bottles to change.

UniCel DxI system with system status panel

If equipped, check the Substrate panel

icons (see Figure 2-2 in Section 2.1:

Supply and Supply Conditions

Overview).

Blinking: Change all empty or expired bottles.

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

Conditions Overview.

UniCel DxI 600 or 800 system

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

Conditions Overview.

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 ( if equipped) 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.

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UniCel DxI Operator's Guide 2.2: Substrate

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.

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.

2

1

3

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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2.2: Substrate UniCel DxI Operator's Guide

5

1

4

3

2

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

2049B.eps

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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UniCel DxI Operator's Guide 2.2: Substrate

1

2

3

4

1

2

2050A.eps

1 Substrate equilibration area

2 Substrate bottle

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

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2.2: Substrate UniCel DxI Operator's Guide

2-22

1

2

3

4

1

2

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.

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UniCel DxI Operator's Guide 2.2: Substrate

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.

16.

Close the reagent load door.

UniCel DxI System with

System Status Panel

Check the Substrate panel icons for container status

UniCel DxI 600 or 800 System

Check the Bulk Supplies 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

Figure 2-12 Changing the Substrate Bottle Flowchart

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2.2: Substrate UniCel DxI Operator's Guide

Scanning the

Substrate Bar

Code Label

Use this procedure to scan the substrate bar code label with the substrate bar code reader.

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.

System Mode: Any Mode

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. If equipped, 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.

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UniCel DxI Operator's Guide 2.2: Substrate

Resolving

Substrate Bar

Code Errors

Two substrate bar code errors can occur while you change a substrate bottle.

• Timeout errors for bar codes not successfully scanned within 30 seconds of 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.

System Mode: Any Mode

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

Enter bar code

(Option) Select to rescan the substrate bar code label.

(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

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

Rescan Bottle option and scan the bottle again.

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2.2: Substrate UniCel DxI Operator's Guide

• 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

In-Use

Substrate

Bottle

You cannot change the in-use substrate bottle if the second bottle is empty or was not loaded, if the second position is disabled, or if the bar code was not scanned.

NOTE

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.

System Mode: Any Mode

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.

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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:

• The Amber status indicator light

• The system status panel (if equipped)

• The Bulk Supplies button

• The Bulk Supplies screen

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2.3: Wash Buffer UniCel DxI Operator's Guide

Monitoring the Wash

Buffer Supply

The following table summarizes the different methods available to monitor wash buffer supply conditions.

• Amber

status indicator light (see Figure 1-3 in Section 1.2: Instrument

Overview)

• Wash Buffer

panel icons (if equipped- 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)

• 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 responding in each of these ways:

• The Amber status indicator light is lit

• One of the Wash Buffer panel icons is lit (if equipped)

• The Bulk Supplies button turns yellow

• On the Bulk Supplies screen, the

Wash Buffer Estimated % Full field turns yellow

• The Amber status indicator light blinks

• Both of the Wash Buffer panel icons blink (if equipped)

• The Bulk Supplies button turns red

• On the Bulk Supplies screen, the

Wash Buffer Estimated % Full field turns red

Then one or more of these wash buffer supply conditions exist:

• One of the on-board containers is low

• One container is not present

• All on-board containers are low

• There is only one on-board container, and it has 10% or less of its volume available for processing

• No containers are present

Table 2-14 Monitoring Wash Buffer Supply

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UniCel DxI Operator's Guide 2.3: Wash Buffer

Changing an

Empty Bulk

Wash Buffer

Container

If there is a sufficient wash buffer supply, the system continues to process tests while you change the empty bulk wash buffer container. To change a wash buffer container

before it is empty, see the Changing an In-Use Bulk Wash Buffer Container

procedure.

Use this procedure to change an empty bulk wash buffer container.

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.

System Mode: Any Mode

1.

Check the wash buffer status to determine which container is in use and how many containers to change.

UniCel DxI system with system status panel

If equipped, check the Wash Buffer

panel icons (see Figure 2-2 in Section

2.1: Supply and Supply Conditions

Overview).

Blinking: Change all low wash buffer containers. If there is only one on-board container, load two new containers.

Solid: Change the wash buffer container that is not in use.

• If you cannot determine the in-use container, consult the Bulk Supplies

screen. For more information, see

Section 2.1: Supply and Supply

Conditions Overview.

UniCel DxI 600 or 800 system

Consult the Bulk Supplies screen (see

Section 2.1: Supply and Supply

Conditions Overview).

If the Wash Buffer Estimated % Full field is red, change all low wash buffer containers. If there is only one on-board container, load two new containers.

If the Wash Buffer Estimated % Full field is yellow, change the wash buffer container that is not in use.

Table 2-15 Checking the Wash Buffer Status

2.

3.

4.

5.

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.

Remove the perforated cardboard panels at the top and the sides of a new wash buffer container.

Gently mix the new wash buffer container.

Place the new wash buffer container on the floor adjacent to the open supply drawer and the container you are replacing.

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2.3: Wash Buffer UniCel DxI Operator's Guide

6.

Grasp the cap on the new container and pull upward until the plastic neck is completely extended.

7.

8.

Remove the cap and inner seal from the new container.

Determine if the wash buffer container is fitted with the original or redesigned

assembly (see Figure 2-16).

1

2

3

5

1

2

3

2-30

4

2378A.eps

Original Cap/Draw Tube Assembly

2376A.eps

Redesigned Cap and Tube Assembly

1 Cap with disconnect button

2 Disconnect button

3 Draw tube

1 Cap with no disconnect button

2 Sensor 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.

© 2022 Beckman Coulter, Inc.

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UniCel DxI Operator's Guide 2.3: Wash Buffer

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).

2

1

4

THIS END UP 3

THIS END UP

FR

ONT

FR

ONT

5

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.

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2.3: Wash Buffer UniCel DxI Operator's Guide

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).

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UniCel DxI Operator's Guide 2.3: Wash Buffer

1

2

3

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.

7.

8.

9.

Lower the cap and tube assembly into the new container and gently tighten the cap.

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.

Carefully push in the drawer. Be sure that none of the wash buffer tubing is pinched between the drawer and the instrument.

Discard the empty container.

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2.3: Wash Buffer UniCel DxI Operator's Guide

UniCel DxI System with

System Status Panel

Check the Wash Buffer panel icons for container status

UniCel DxI 600 or 800 System

Check the Bulk Supplies screen for container 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 cap and tube assembly?

No

Yes

Press the disconnect button on the empty container to release the tubing

Remove the shim from the empty container and slide it into place on the new container

Remove the empty container from the drawer and set it beside the new container

Remove the empty container from the drawer and replace it with the new container

Remove the cap and tube assembly from the empty container and insert it into the new container

Remove the cap and tube assembly from the empty container and insert it into the new container

Tighten the cap and set the new container in the drawer

Connect the tubing to the new container and close the drawer

Route the tubing alongside the new container and close the drawer

2018E.svg

Figure 2-19 Changing an Empty Bulk Wash Buffer Container Flowchart

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UniCel DxI Operator's Guide 2.3: Wash Buffer

Changing an

In-Use Bulk

Wash Buffer

Container

You cannot change the in-use bulk wash buffer container if the second wash buffer container is empty or was not loaded, or if the second position is disabled.

Use this procedure to change the in-use bulk wash buffer container.

System Mode: Any Mode

1.

From the Bulk Supplies screen, select Change In-Use Bottle F3 .

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

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.

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:

• The Amber status indicator light

• The system status panel (if equipped)

• The Bulk Supplies button

• The Bulk Supplies screen

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UniCel DxI Operator's Guide 2.4: Reaction Vessels

Monitoring the RV Supply

The following table summarizes the different methods available to monitor RV supply conditions.

• Amber

status indicator light (see Figure 1-3 in Section 1.2: Instrument

Overview)

• RVs

panel icon (if equipped - 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)

• Estimated RVs Left

field on the Bulk Supplies screen (see Figure 2-3 in

Section 2.1: Supply and Supply Conditions Overview)

If the system indicators are responding in each of these ways:

• The Amber status indicator light is lit

• The RVs panel icon is lit (if equipped)

• The Bulk Supplies button turns yellow

• On the Bulk Supplies screen, the

Estimated RVs Left field turns yellow

• The Amber status indicator light blinks

• The RVs panel icon blinks (if equipped)

• The Bulk Supplies button turns red

• On the Bulk Supplies screen, the

Estimated RVs Left field turns red

Then one or more of these RV supply conditions exist:

• The RV supply is low (fewer than

1,000 RVs)

• The RV supply is very low (fewer than 100 RVs)

• The RV supply is depleted

Table 2-20 Monitoring RV Supply

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2.4: Reaction Vessels UniCel DxI Operator's Guide

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.

System Mode: Any Mode

1.

Check the RV status to determine how many bags of RVs to add to the vessel hopper.

UniCel DxI system with system status panel

If equipped, check the

(see Figure 2-2 in Section 2.1: Supply and Supply Conditions Overview).

Solid:

RVs panel icons

Blinking: Add enough RVs to fill the vessel hopper (nearly two bags).

Add one bag of RVs.

UniCel DxI 600 or 800 system

Consult the Bulk Supplies screen to

determine how many RVs to add (see

Section 2.1: Supply and Supply

Conditions Overview).

If there are fewer than 100 RVs, add 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.

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UniCel DxI Operator's Guide 2.4: Reaction Vessels

1

2

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.

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2.4: Reaction Vessels UniCel DxI Operator's Guide

UniCel DxI System with

System Status Panel

Check the RVs panel icon for the number of RVs required

UniCel DxI 600 or 800 System

Check the Bulk Supplies screen for RV status

Open the vessel hopper door

Open a bag of RVs and pour the contents into the vessel hopper

Close the vessel hopper door

Figure 2-23 Adding RVs Flowchart

2019D.svg

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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.

You can use the following system indicators to monitor your on-board liquid waste levels:

• The Amber status indicator light

• The system status panel (if equipped)

• The Bulk Supplies button

• The Bulk Supplies screen

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2.5: Liquid Waste UniCel DxI Operator's Guide

Monitoring the Liquid

Waste Supply

The following table summarizes the different methods available to monitor liquid waste supply conditions if your system uses on-board bulk liquid waste containers.

• Amber

status indicator light (see Figure 1-3 in Section 1.2: Instrument

Overview)

• Liquid Waste

panel icons (if equipped - 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)

• 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 responding in each of these ways:

• The Amber status indicator light is lit

• One of the Liquid Waste panel icons is lit (if equipped)

• The Bulk Supplies button turns yellow

• On the Bulk Supplies screen, the

Liquid Waste Estimated % Empty field turns yellow

• The Amber status indicator light blinks

• Both of the Liquid Waste panel icons blink (if equipped)

• The Bulk Supplies button turns red

• On the Bulk Supplies screen, the

Liquid Waste Estimated % Empty field turns red

Then one or more of these liquid waste supply conditions exist:

• One of the on-board containers is almost full

• One container is not present

• All on-board containers are almost full

• There is only one on-board container, and it has 9% or less of its volume available for collecting waste

• No containers are present

Table 2-24 Monitoring Liquid Waste Supply

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UniCel DxI Operator's Guide 2.5: Liquid Waste

Changing a

Full Bulk

Liquid Waste

Container

Use this procedure only if your DxI system uses on-board bulk liquid waste containers.

If there is sufficient volume available for collecting waste, the system continues to 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.

System Mode: Any Mode

1.

Check the liquid waste status to determine which container is in use and how many containers to change.

UniCel DxI system with system status panel

If equipped, check the Liquid Waste

panel icons (see Figure 2-2 in Section

2.1: Supply and Supply Conditions

Overview).

Blinking: Change all liquid waste containers. If there is only one on-board container, load two new containers.

Solid: Change the liquid waste container that is not in use.

• If you cannot determine the in-use container, consult the Bulk Supplies

screen. For more information, see

Section 2.1: Supply and Supply

Conditions Overview.

UniCel DxI 600 or 800 system

Consult the Bulk Supplies screen (see

Section 2.1: Supply and Supply

Conditions Overview).

If the Liquid Waste Estimated %

Empty field is red, change all liquid waste containers. If there is only one on-board container, load two new containers.

If the Liquid Waste Estimated %

Empty field is yellow, change the liquid waste container that is not in use.

Table 2-25 Checking the Liquid Waste Status

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2.5: Liquid Waste UniCel DxI Operator's Guide

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.

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.

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UniCel DxI Operator's Guide

1

2

3

5

4

2.5: Liquid Waste

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

2087A.eps

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2.5: Liquid Waste UniCel DxI Operator's Guide

UniCel DxI System with

System Status Panel

Check the Liquid Waste panel icons for container status

UniCel DxI 600 or 800 System

Check the Bulk Supplies screen for container 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

2020D.svg

Figure 2-27 Changing a Full Bulk Liquid Waste Container Flowchart

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UniCel DxI Operator's Guide 2.5: Liquid Waste

Changing an

In-Use Bulk

Liquid Waste

Container

Use this procedure only if your DxI system uses on-board bulk liquid waste containers.

If there is sufficient volume available for collecting waste, the system continues to 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.

System Mode: Any Mode

1.

From the Bulk Supplies screen, select Change In-Use Bottle F3 .

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.

© 2022 Beckman Coulter, Inc.

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2.6: Solid Waste UniCel DxI Operator's Guide

2-48

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:

• The Amber status indicator light

• The system status panel (if equipped)

• The Bulk Supplies button

• The Bulk Supplies screen

© 2022 Beckman Coulter, Inc.

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UniCel DxI Operator's Guide 2.6: Solid Waste

Monitoring the Solid

Waste Supply

The following table summarizes the different methods available to monitor solid waste supply conditions.

• Amber

status indicator light (see Figure 1-3 in Section 1.2: Instrument

Overview)

• Solid Waste

panel icon (if equipped - 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)

• 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 responding in each of these ways:

• The Amber status indicator light is lit

• The Solid Waste panel icon is lit (if equipped)

• The Bulk Supplies button turns yellow

• On the Bulk Supplies screen, the

Solid Waste Estimated % Empty field turns yellow

• The Amber status indicator light blinks

• The Solid Waste panel icon blinks

(if equipped)

• The Bulk Supplies button turns red

• On the Bulk Supplies screen, the

Solid Waste Estimated % Empty field turns red

Then one or more of these solid waste supply conditions exist:

• The container has 10% or less of its volume available for collecting waste

• The container is too full to schedule any new tests

• The container is full

Table 2-28 Monitoring Solid Waste Supply

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2.6: Solid Waste UniCel DxI Operator's Guide

Changing a

Full Solid

Waste

Container

The system continues processing tests while you change the full solid waste container, but does not initiate any new test requests. The system does not dispose of any solid waste until the empty container is in place again.

Use this procedure to change the solid waste container bag.

WARNING

You will come in contact with potentially infectious materials during this procedure. Handle and dispose of biohazard materials according to proper laboratory procedures. Proper hand, eye, and facial protection is required.

CAUTIONS

• If you change a full solid waste container while the system is in the

Running or Paused mode, be sure to complete the procedure within five minutes. Solid waste may accumulate and obstruct the waste chute if it takes longer than five minutes to change the container.

• Do not 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.

System Mode: Any Mode

1.

Check the solid waste status.

UniCel DxI system with system status panel

If equipped, check the

Overview).

Blinking: container.

Solid:

Solid Waste

panel icon (see Figure 2-2 in Section

2.1: Supply and Supply Conditions

Change the solid waste

The solid waste container is almost full, change the container soon.

UniCel DxI 600 or 800 system

Consult the Bulk Supplies screen (see

Section 2.1: Supply and Supply

Conditions Overview).

If the Solid Waste Estimated % Empty field is red, change the solid waste container.

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

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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.

3

2

1

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.

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2.6: Solid Waste UniCel DxI Operator's Guide

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.

UniCel DxI System with

System Status Panel

Check the Solid Waste panel icon for container status

UniCel DxI 600 or 800 System

Check the Bulk Supplies screen for container 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

Figure 2-31 Changing a Full Solid Waste Container Flowchart

2021D.svg

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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 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.

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2.7: Reagent Supplies UniCel DxI Operator's Guide

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

Conditions Overview.

You can use the following system indicators to monitor your on-board reagent supply levels:

• The Amber status indicator light

• The system status panel (if equipped)

• The Supplies Required button

• The Supplies Required screen

Monitoring the Reagent

Pack Supply

The following table summarizes the different methods available to monitor reagent pack supply conditions. You can monitor supply conditions for individual packs on the Reagent Supplies screen.

• Amber

status indicator light (see Figure 1-3 in Section 1.2: Instrument

Overview)

• Console

panel icon (if equipped - see Figure 2-2 in Section 2.1: Supply and

Supply Conditions Overview)

• 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 responding in each of these ways:

• The Amber status indicator light is lit

• The Console panel icon is lit (if equipped)

• The Supplies Required button turns yellow

• A pack is displayed on the Supplies

Required screen

Then one or more of these reagent pack supply conditions exist:

• No on-board reagent pack

• A pack is on-board, but does not have enough reagent to process all tests

• Pack lot expired

• Open pack stability expired

Table 2-32 Monitoring Reagent Pack Supply

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UniCel DxI Operator's Guide

Reagent

Supplies

Screen

2.7: Reagent Supplies

Use the Reagent Supplies screen to:

• View specific details about the on-board reagent packs

• 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 .

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2.7: Reagent Supplies UniCel DxI Operator's Guide

Reagent Pack

Button

For each on-board reagent pack, the button displays the following information:

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

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UniCel DxI Operator's Guide 2.7: Reagent Supplies

Reagent Pack

Button, continued

In-Use Icon

(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

F1

Unload Reagent

Packs

F2

Unload All Reagent

Packs

F3

Details

F6

(Button) Select to display the Bulk Supplies screen. For more information, see the

Bulk Supplies Screen topic in Section 2.1: Supply and Supply Conditions

Overview.

(Button) Select to unload individual reagent packs. You can unload up to four reagent packs at a time on the UniCel DxI 800 instrument (up to two packs at a

time on the UniCel DxI 600 instrument). For more information, see the Unloading a Reagent Pack procedure.

(Button) Select to unload all of the reagent packs from the reagent storage

chamber. For more information, see the Unloading All Reagent Packs procedure.

Print

F7

Reagent Inventory

F8

(Button) After selecting a Reagent Pack button, select to display more detailed 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.

(Button) Select to print the Reagent Supplies Report for all on-board reagent packs.

For more information, see the Displaying and Printing Reagent Pack Details

procedure.

(Button) Select to display the Reagent Inventory screen. For more information, see

Section 2.8: Reagent Inventory.

Figure 2-33 Reagent Supplies Screen Descriptions (continued)

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2.7: Reagent Supplies UniCel DxI Operator's Guide

Displaying and Printing

Reagent Pack

Details

The Reagent Supplies screen displays summary information about each on-board reagent pack. The Reagent Supplies Report provides summary information about all on-board reagent packs. This report does not print information for individual reagent packs.

Use this procedure to display detailed information for one reagent pack, or to print the

Reagent Supplies Report.

System Mode: Any Mode

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

• Lot Number

• Serial Number

• Dilutions Remaining

(for diluent packs only)

4.

Pack Expiration Date

Calibration Expiration Date

Tests Left

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 .

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Reagent Supplies Report

UniCel DxI 800, Access Immunoassay System

S/N 654321

Laboratories, Inc.

Laboratory A

123 Lake Street

Townsville, ST 33333

101-555-2323 ext. 109 Jane Smith

CK-MB

CK-MB

Ferritin

Ferritin

Ferritin

Ferritin

Ferritin

Ferritin

CK-MB

CK-MB

CK-MB

CK-MB

CK-MB

CK-MB

CK-MB

CK-MB

TSH

TSH fTSH2

TSH

TSH fTSH2

MYO

MYO

Test Name Lot No.

013040

013055

105011

125002

125002

105011

125002

125002

085673

013055

013055

013040

013055

013055

013040

013055

013055

085673

093738

093738

483

484

841

842

2297

2296

2298

3011

Serial No.

Tests

Left

231

232

2

2

234

235

236

481

2

25

25

25

3012

3010

3013

27

38

5

17

27

38

17

50

50

10

50

3

5

5

4

0

0

12

0

4

3

12

6

4

8

6

8

8

Days

Open

3454

3461

3462

Technologist ____________________

5

47

47

12

7

7

Pack

Expiration

04/27/04

04/27/04

04/27/04

02/28/04

02/28/04

02/28/04

01/31/04

01/31/04

04/20/04

01/31/04

04/27/04

04/28/04

04/29/04

04/27/04

04/28/04

04/29/04

04/06/04

Calib.

Expiration

10/15/03

10/15/03

None

10/15/03

10/15/03

None

10/15/03

10/15/03

None

10/15/03

10/30/03

None

None

10/30/03

None

None

10/20/03

None

04/06/04

04/25/04

04/25/04

10/20/03

None

10/15/03

10/15/03

Slot

13

13

15

16

17

9

10

11

12

7

8

5

6

3

4

1

2

18

19

20

Instrument

654321

654321

654321

654321

654321

654321

654321

654321

654321

654321

654321

654321

654321

654321

654321

654321

654321

654321

654321

654321

Page 1 of 1

Printed 10/10/2003 14:36

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Figure 2-34 Reagent Supplies Report Example

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2.7: Reagent Supplies UniCel DxI Operator's Guide

Loading a

Reagent Pack

If there is sufficient reagent available, the system continues to process tests while you load another reagent pack.

Use this procedure to load reagent packs onto the instrument.

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.

• 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 .

System Mode: Any Mode

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.

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1

2

3

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.

2085B.eps

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.

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2.7: Reagent Supplies UniCel DxI Operator's Guide

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

2

3

4

2-62

1 Reagent pack

2 Reagent pack position

3 Reagent load tray

Figure 2-36 UniCel DxI 800 Instrument: Loading a Reagent Pack

2086A.eps

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UniCel DxI Operator's Guide

1

2

3

1

2

3

4

2.7: Reagent Supplies

1 Reagent pack

2 Reagent pack position

3 Reagent load tray

Figure 2-37 UniCel DxI 600 Instrument: Loading a Reagent Pack

2086B.eps

5.

Close the reagent load door.

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

Is the light off?

No Wait until the green light turns off

Yes

Gently mix the packs and open the reagent load door *

DxI 800:

Place up to 4 packs in the tray positions

DxI 600:

Place up to 2 packs in the tray positions

* For the Access 25(OH)

Vitamin D Total assay, see the reagent IFU for reagent pack mixing instructions

Close the reagent load door

Figure 2-38 Loading a Reagent Pack Flowchart

2022D.wmf

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UniCel DxI Operator's Guide 2.7: Reagent Supplies

Unloading a

Reagent Pack

The system automatically unloads empty reagent packs and places them in the solid 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

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.

System Mode: Any Mode

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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2.7: Reagent Supplies UniCel DxI Operator's Guide

5.

Close the reagent load door.

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

DxI 800:

Select up to 4 reagent packs

DxI 600:

Select up to 2 reagent packs

Unload Reagent Pack F2

Reagent Inventory

Select one reagent pack

Unload Reagent Pack F2

Wait for the reagent tray in-use light to turn off

Open the reagent load door and remove the packs

Close the reagent load door

Figure 2-39 Unloading a Reagent Pack Flowchart

2023C.svg

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UniCel DxI Operator's Guide 2.7: Reagent Supplies

Unloading All

Reagent

Packs

Use this procedure to unload all reagent packs from the system. The system unloads the packs, but maintains all pack information in the database.

WARNING

You will come in contact with potentially infectious materials during this procedure. Handle and dispose of biohazard materials according to proper laboratory procedures. Proper hand, eye, and facial protection is required.

S ystem Mode:

1.

Ready Not Ready

From the Reagent Supplies screen, select Unload All Reagent Packs F3 to display the Unload All Packs window.

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Moving Packs to Tray

Unload all Packs -

% Complete

Packs to Unload

Cancel

F8

2030A.bmp

(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.

(Field) Monitors the system as it removes all reagent packs from the reagent storage chamber.

(Field) Displays the number of reagent packs remaining in the reagent storage chamber.

(Button) Select to stop unloading the remaining on board reagent packs.

Figure 2-40 Unload All Packs Window Descriptions

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2.7: Reagent Supplies UniCel DxI Operator's Guide

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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UniCel DxI Operator's Guide 2.7: Reagent Supplies

(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

Close the reagent load door

Are all of the packs unloaded?

No

Yes

Continue unloading packs

Select Exit F1

Figure 2-41 Unloading All Reagent Packs Flowchart

2024B.svg

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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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Reagent

Inventory

Screen

2.8: Reagent Inventory

Use the Reagent Inventory screen to:

• View the reagent pack inventory

• 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 .

Filter

Open Slots

Entries

2031A.bmp

(Field) Displays the applied filter and sort order.

(Field) Displays the number of empty reagent pack positions in the reagent storage chamber.

(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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2.8: Reagent Inventory UniCel DxI Operator's Guide

Test Name

Lot No.

Serial No.

Tests Left

Days Open

Pack Expiration

Calib. Expiration

Slot

Instrument

(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).

(Column) Displays each pack lot number.

(Column) Displays the unique pack serial number.

(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.

(Column) Displays the number of days since the system first punctured each reagent pack.

(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.

(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

This column is not updated in real-time. To refresh the information on the screen, exit the screen and redisplay it.

For more information, see Chapter 5: Assay Calibration.

(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.

(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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Reagent Supplies

F1

Unload Reagent

Pack

F2

Delete Pack

F5

Print

F7

Filter

F8

(Button) Select to display the Reagent Supplies screen. For more information, see

Section 2.7: Reagent Supplies.

(Button) Select to unload one selected reagent pack. If the selected reagent pack is

off board this button is not available. For more information, see the Unloading a

Reagent Pack procedure in Section 2.7: Reagent Supplies.

The system updates the screen once the pack is unloaded.

NOTE

This column is not updated in real-time. To refresh the information on the screen, exit the screen and redisplay it.

(Button) Select to delete an off-board reagent pack from inventory. When you 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.

(Button) Select to print the Reagent Inventory Report for all reagent packs that

meet the filter parameters. For more information, see the Printing the Reagent

Inventory Report procedure.

(Button) Select to change the filter parameters and sort order to apply to the

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

Filter to the

Reagent

Inventory

Screen

A filter is a set of parameters you can apply to increase or decrease the number of reagent packs that display on the Reagent Inventory screen.

Use this procedure to apply a different filter to the Reagent Inventory screen.

System Mode: Any Mode

1.

From the Reagent Inventory screen, select Filter F8 to display the Filter window.

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2.8: Reagent Inventory UniCel DxI Operator's Guide

2-74

Filter

Pack Type

Sort Order

Ascending

2032B.bmp

(List) Select a filter that describes the inventory entries to be displayed on the Reagent Inventory screen.

(List) Select a pack type that describes the inventory entries to be displayed on the Reagent Inventory screen.

(Options) Select the pack attribute by which the packs are sorted on the screen.

(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 .

© 2022 Beckman Coulter, Inc.

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UniCel DxI Operator's Guide

© 2022 Beckman Coulter, Inc.

C95317-AA

2.8: Reagent Inventory

3.

4.

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 .

Select a sort order option.

5.

6.

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.

Select or clear the Ascending option.

Select OK F1 .

The Reagent Inventory screen displays the reagent inventory according to the applied filter.

Deleting a

Reagent Pack

Use this procedure to delete off-board reagent packs from inventory.

System Mode: Any Mode

NOTES

• You cannot reload a reagent pack after you delete it.

1.

• The system automatically unloads and deletes empty reagent packs from inventory.

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.

4.

Select Delete Pack F5 .

The system displays a confirmation window.

Select OK F1 .

The system deletes the reagent pack.

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2.8: Reagent Inventory UniCel DxI Operator's Guide

(Any Screen)

Bulk Supplies

Reagent Inventory F8

Reagent Inventory

Select the pack you intend to delete

Is the pack off board?

No

Yes

Delete Pack F5

OK F1

Unload the pack

Figure 2-44 Deleting a Reagent Pack Flowchart

2025C.svg

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UniCel DxI Operator's Guide 2.8: Reagent Inventory

Printing the

Reagent

Inventory

Report

Use this procedure to print the Reagent Inventory Report, containing all selected packs or all packs in the applied filter.

System Mode: Any Mode

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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2.8: Reagent Inventory UniCel DxI Operator's Guide

Test Name

Ferritin

Ferritin

Dig

Dig

Dig

Dig

CK-MB

CK-MB

CK-MB

PSA-Hyb

PSA-Hyb

PSA-WHO

MYO

TSH

TSH fTSH2

Ferritin

Reagent Inventory Report

UniCel DxI 800, Access Immunoassay System

S/N 654321

Laboratories, Inc.

Laboratory A

123 Lake Street

Townsville, ST 33333

101-555-2323 ext. 109 Jane Smith

105011

125002

125002

123123

123123

123123

123123

013055

013055

013040

Lot No.

066851

093738

085673

1259

3374

1121

11863

8715

4168

1122

956

842

1010

Filter:

Serial No.

3461

14283

232

47

0

0

50

17

27

38

50

50

10

Tests

Left

8

47

5

7

12

18

0

3

0

5

4

0

12

All Packs -- Sorted by Test Name

Days

Open

20

Pack

Expiration

06/30/04

Calib.

Expiration

7

12

04/25/04

04/06/04

10/18/03

None

10/15/03

04/27/04

04/28/04

04/29/04

01/31/04

01/31/04

01/31/04

01/31/04

04/27/04

04/27/04

04/27/04

10/20/03

None

10/12/03

Unloaded

Unloaded

10/15/03

10/15/03

10/15/03

10/15/03

None

None

10/15/03

8

3

6

15

14

9

1

2

4

17

Slot

4

Instrument

654321

654321

654321

654321

654321

654321

654321

654321

654321

654321

654321

2-78

Technologist ____________________

Page 1 of 1

Printed 10/10/2003 14:36

Figure 2-45 Reagent Inventory Report Example

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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

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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.

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3.1: Sample Manager Overview UniCel DxI Operator's Guide

3-4

Query the LIS for test requests

Download test requests from the LIS

Manually enter test requests

Sample Manager

(Any Screen)

Work Pending

Check the screen for test requests downloaded from the LIS

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, calibration, or patient sample condition

Access the Supplies

Required or Work Pending

Screens

Continue to monitor sample processing

New Request F3

Patient/QC Requests F1

Test Requests

Enter the rack ID and then the sample ID, test requests, and sample information for each sample

3002C.wmf

Figure 3-1 Sample Processing Overview Flowchart

© 2022 Beckman Coulter, Inc.

C95317-AA

UniCel DxI Operator's Guide

Sample

Manager

Screen

3.1: Sample Manager Overview

Use the Sample Manager screen to:

• 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

Figure 3-2 Sample Manager Screen, In Progress View

2035A.bmp

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3-5

3.1: Sample Manager Overview UniCel DxI Operator's Guide

Sample Manager

Screen View

Buttons

Rack

2166A.bmp

(Buttons) There are four Screen View buttons. Each button corresponds to a

specific screen view. For more information, see the Sample Manager Screen Views

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.

(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

Description

(Exceptions view only)

(Column) Displays the position of the sample in the rack, from 1-4.

(Column) Displays a description of the associated sample error.

Figure 3-3 Sample Manager Screen Descriptions

3-6 © 2022 Beckman Coulter, Inc.

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UniCel DxI Operator's Guide 3.1: Sample Manager Overview

Sample ID

Patient ID

Status

(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.

(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.

(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.

(Column) Displays the estimated completion time for each sample.

Complete

NOTE

This column is not displayed on the Requested or Exceptions views.

(Column) Displays the time the associated sample error occurred.

Creation Time

(Exceptions view only)

Sample Aliquot

Station

(Field and Icon) Displays the racks that are currently in the sample aliquot 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)

© 2022 Beckman Coulter, Inc.

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3.1: Sample Manager Overview UniCel DxI Operator's Guide

Exceptions

Views

F1

Edit Request

F2

(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.

(Button) Select to display one of the four Sample Manager screen views. For more

information, see the Selecting a Sample Manager Screen View procedure.

(Button) Select to edit a request on the selected rack. The Test Requests screen that 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.

Clear Exceptions

F2

(Only available on the Exceptions view)

NOTE

This button is only available on the Requested or Daily views.

(Button) Select to remove a sample from the Exceptions view. For more

information, see the Clearing an Exception from the Exceptions View procedure.

Figure 3-3 Sample Manager Screen Descriptions (continued)

3-8 © 2022 Beckman Coulter, Inc.

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UniCel DxI Operator's Guide 3.1: Sample Manager Overview

New Request

F3

Test Results

F4

Work Pending

F5

Find

F6

Details

F8

(Button) Select to request a new test request. There are three different types of test requests.

Patient/QC Requests F1

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.

(Button) Select to display the Test Results screen. Test requests begin to display on the Test Results screen when the samples are aliquoted by the system. For more

information, see Section 4.1: Test Results Overview.

(Button) Select to display the Work Pending screen. For more information, see

Section 3.2: LIS Requests and Work Pending.

(Button) Select to locate a specific sample ID on the Sample Manager screen. For

more information, see the Finding a Sample ID procedure.

NOTE

This button is not available on the Exceptions view.

(Button) Select to display detailed information about the tests for a selected

sample. For more information, see the Displaying Test Details procedure.

NOTE

This button is only available on the In Progress or Daily views.

Figure 3-3 Sample Manager Screen Descriptions (continued)

© 2022 Beckman Coulter, Inc.

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3.1: Sample Manager Overview UniCel DxI Operator's Guide

Sample

Manager

Screen Views

The Sample Manager screen features four screen views. Each view arranges and presents sample status information in a specific way. You can select a new screen

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.

3-10 © 2022 Beckman Coulter, Inc.

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UniCel DxI Operator's Guide 3.1: Sample Manager Overview

Selecting a

Sample

Manager

Screen View

Use this procedure to select one of the four screen views.

System Mode: Any Mode

From the Sample Manager screen, select the appropriate Screen View button located

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

Date on the

Daily View

Use this procedure to display a specific 24-hour time period on the Daily view of the

Sample Manager screen.

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

Exception from the

Exceptions

View

Use this procedure to clear a sample exception from the Exceptions view of the

Sample Manager screen.

System Mode: Any Mode

1.

From the Sample Manager screen, select the Exceptions button to display the

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.

4.

Select Clear Exceptions F2 .

In the Clear Exceptions window, select an option from the Clear What list.

© 2022 Beckman Coulter, Inc.

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3-11

3.1: Sample Manager Overview

Finding a

Sample ID

UniCel DxI Operator's Guide

5.

• 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 .

Select OK F1 to clear the exceptions from the screen.

Use this procedure to find a specific sample ID on the Sample Manager screen.

System Mode: Any Mode

1.

2.

3.

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.

From the Sample Manager screen, select Find F6 to display the Find window.

In the Find Sample ID field, enter either the complete or partial sample ID of the sample you intend to find.

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.

3-12 © 2022 Beckman Coulter, Inc.

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UniCel DxI Operator's Guide 3.1: Sample Manager Overview

Displaying

Test Details

Use this procedure to display test details for a selected sample.

System Mode: Any Mode

1.

2.

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.

From either the In Progress or Daily views of the Sample Manager screen, select the sample whose test detail information you intend to view.

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.

© 2022 Beckman Coulter, Inc.

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3-13

3.1: Sample Manager Overview UniCel DxI Operator's Guide

Resolving

Sample Errors

Use this procedure to resolve a sample error. You can view all of the samples with an 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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• 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

Screen

You use the Work Pending screen to:

• 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

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UniCel DxI Operator's Guide 3.2: LIS Requests and Work Pending

Filter

Tests Requested

LIS Workpool

Sample ID

Patient ID

Requested

Tests Pending

Origin

(Rack/Instrument)

Filter

F1

(Field) Displays the applied filter and sort order.

(Field) Displays the total number of tests in the work pending list that meet the filter parameters.

(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.

(Column) Displays the sample ID for each sample in the work pending list.

(Column) Displays the required patient ID for LIS requests, or the lot number for

QC requests.

(Column) Displays the date and time of the original test request.

(Column) Displays the names of the tests that are pending. Each test name is displayed in a separate row.

(Column) Displays the origin of the test request in the work pending list.

• 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.

(Button) Select to change the filter parameters and sort order for the Work Pending 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

F2

Delete

F6

Print

F7

Options

F8

(Button) Select to display the Sample Manager screen. For more information, see the

Sample Manager Screen topic in Section 3.1: Sample Manager Overview.

(Button) Select to delete tests from the work pending list. For more information, see the Deleting Tests from Work Pending procedure.

(Button) Select to print the Work Pending Report. For more information, see the

Printing the Work Pending Report procedure.

(Button) Select to display the Options window. From the Options window, you can 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

LIS Test

Requests

Use this procedure to process test requests downloaded from the LIS. When you load bar coded sample containers for the tests listed on the Work Pending screen, the system matches the downloaded test requests to the samples and runs the tests.

System Mode: Running Paused

1.

2.

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 .

From any screen, select the Work Pending button to display the Work Pending screen.

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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UniCel DxI Operator's Guide 3.2: LIS Requests and Work Pending

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.

4.

5.

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.

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.

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

Work Pending button turns yellow

No Are there LIS requests?

Yes Place the samples listed on the screen in racks

Load the racks, loading any racks with STAT samples first

2095C.wmf

Figure 3-5 Downloading LIS Test Requests Flowchart

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3.2: LIS Requests and Work Pending UniCel DxI Operator's Guide

Querying the

LIS for Test

Requests

Use this procedure to query the laboratory information system (LIS) for test requests.

System Mode: Running Paused

1.

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 .

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 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.

2.

3.

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.

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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UniCel DxI Operator's Guide 3.2: LIS Requests and Work Pending

Applying a

Filter to the

Work Pending

Screen

The work pending filter is a set of parameters that you can apply to designate the kinds of test requests to be displayed on the Work Pending screen.

Use this procedure to apply different filter parameters or a different sort order to the

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.

System Mode: Any Mode

1.

From the Work Pending screen, select Filter F1 to display the Filter window.

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Filter (Boxes) Select one or more kinds of pending test requests to include in the filter.

2139C.bmp

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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3.2: LIS Requests and Work Pending UniCel DxI Operator's Guide

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 from Work

Pending

Use this procedure to delete pending tests displayed on the Work Pending screen.

System Mode: Any Mode

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.

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UniCel DxI Operator's Guide 3.2: LIS Requests and Work Pending

Delete

What

(Option) Select the tests that you will delete from the Work

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

Work Pending

Report

Use this procedure to print the Work Pending Report, which lists the pending test requests that meet the applied filter parameters.

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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Work Pending Report

UniCel DxI 800, Access Immunoassay System

S/N 654321

Filter:

Tests Requested:

LIS Workpool:

Laboratories, Inc.

Laboratory A

123 Lake Street

Townsville, ST 33333

101-555-2323 ext. 109 Jane Smith

Reflex Tests, Manual Rerun, LIS Requests, Sample Expiration, Insufficient Sample Volume, Other

6

4

Sample ID

80140-0055

80140-0061

80140-0062

80140-0083

80140-0099

80140-0102

Patient ID

651923376

834770845

534996247

559010587

661030189

750112726

Requested

10/10/03 08:12:09 AM

10/10/03 08:50:34 AM

10/10/03 08:59:59 AM

10/10/03 09:51:04 AM

10/10/03 10:03:11 AM

10/10/03 12:15:55 PM

Tests Pending

TSH

Prog

TSH

TSH

TSH hLH

Origin (Rack/Instrument)

LIS (Unknown)

LIS (Unknown)

LIS (Unknown)

LIS (Unknown)

Manual Rerun (Unknown)

Reflex (Unknown)

3-24

Technologist ____________________

Figure 3-8 Work Pending Report Example

Page 1 of 1

Printed 10/10/2003 14:36

2147D.bmp

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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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Test Requests

Screen for

Patient/QC

Samples

Use the Test Requests screen to:

• Enter manual test requests.

• Enter test requests for calibration and quality control samples. For more

information, see Section 5.3: Running a Calibration, or see

Section 6.3: Running Quality Control Tests.

• Edit or delete test requests.

Rack Button and

Enter ID

Auto Sample ID

2068D.bmp

(Button and Field) Displays the rack ID, and the position and sample ID of each container in the rack.

Select the Rack button to enter or change the rack ID. The Enter ID field is displayed.

(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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UniCel DxI Operator's Guide 3.3: Patient Test Requests

Batch Request

Position

Sample ID

Patient ID/Lot

Number

(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.

(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.

(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.

(Field) Displays an optional value that identifies the patient whose sample is being 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.

Dilution

Sample Type

• For QC test requests, the system enters the control lot number in this field when you select a control from the Request QC window.

(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.

(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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3.3: Patient Test Requests UniCel DxI Operator's Guide

STAT

Comment

(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.

( 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.

Tests Requested for Sample X

Test

The system displays sample comments on test result reports and on the Quality

Control screen and reports.

(Field) Displays a list of all the tests requested for a selected sample ( X is the 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.

(Field) Displays the test ID for the selected test.

• To add a replicate, press the [+] key.

• To remove a replicate, press the [-] key.

Figure 3-9 Test Requests Screen Descriptions for Patient/QC Samples (continued)

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UniCel DxI Operator's Guide 3.3: Patient Test Requests

Test Buttons

Remove

Rack ID

F1

Delete Sample

F2

New Request

F3

Test Results

F4

Request QC

F5

Cancel Request

F6

Clear All Samples

F7

(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.

(Button) Select to remove one replicate of the selected test in the Tests Requested for Sample X list.

(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 Manual Test

Requests procedure or see Section 3.6: Editing Test Requests.

(Button) Select to delete the sample selected on the Test Requests screen. For more

information, see Section 3.6: Editing Test Requests.

(Button) Select to exit this request and to request a new test request. There are three different test request types.

Patient/QC Requests F1

Select to request tests for patient samples and quality controls. For more

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

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.

(Button) Select to display the Test Results screen. Test requests begin to display on the Test Results screen when the samples are aliquoted by the system. For more

information, see Section 4.3: Reviewing Test Results.

(Button) For quality control samples, select to display the Request QC window.

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.

(Button) Select to cancel the test request and to return to the Sample Manager

screen. For more information, see Section 3.6: Editing Test Requests.

(Button) Select to clear the sample information for each sample on the selected rack.

Figure 3-9 Test Requests Screen Descriptions for Patient/QC Samples (continued)

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More Options

F8

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

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.

Figure 3-9 Test Requests Screen Descriptions for Patient/QC Samples (continued)

Manual Test

Requests

3-30

Use this procedure to manually enter patient test requests that do not originate from 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.

2.

• 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 .

System Mode: Any Mode

1.

From the Sample Manager screen (see Figure 3-3 in Section 3.1: Sample

Manager Overview), select

New Request F3 .

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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UniCel DxI Operator's Guide 3.3: Patient Test Requests 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

Calibration Screen topic in Section 5.1: Assay Calibration Overview.

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

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.

 (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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UniCel DxI Operator's Guide 3.3: Patient Test Requests

NOTE

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.

Load the racks. For more information, see Section 3.4: Loading and Unloading Racks.

Sample Manager

New Request F3

Patient/QC Requests F1

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 contain a STAT sample?

No

Yes

Place the requested samples in a rack

Are all tests requested?

No

Yes

New Request F3

Load the rack

Figure 3-10 Manual Test Requests Flowchart

2096C.svg

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3.3: Patient Test Requests UniCel DxI Operator's Guide

Using Auto

Sample ID

The Auto Sample ID option automatically assigns sequential sample IDs during 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.

System Mode: Any Mode

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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UniCel DxI Operator's Guide 3.3: Patient Test Requests

Using Batch

Request

The Batch Request option automatically assigns the same test list from the previous sample to the next sample.

Use this procedure to turn the Batch Request option on and off.

System Mode: Any Mode

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

Service

Assays

Your technical support representative may use service assays for instrument diagnostics.

NOTE

Use this function only as directed by your technical support representative.

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3.3: Patient Test Requests UniCel DxI Operator's Guide

Reusing

Sample IDs

Patient samples are identified by a unique sample ID. For 30 days after a patient test 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

Deleting

Sample

Comments

Use this procedure to enter, edit, or delete sample comments on the Test Requests screen.

System Mode: Any Mode

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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UniCel DxI Operator's Guide 3.3: Patient Test Requests

Configuring the Automatic

Rerun Feature

Use this procedure to configure the system to automatically rerun patient and control tests that are cancelled due to system errors characterized by the fatal flags listed

below. For more information, see the Test Result Flags and Troubleshooting topic in

Section 4.3: Reviewing Test Results.

• CLT

• RLU

• QNS

• SYS

• QSB

• TRI

• QSD

• TRS

• QSS

• 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.

System Mode: Any Mode

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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3.3: Patient Test Requests UniCel DxI Operator's Guide

Rerun cancelled tests automatically

Figure 3-11 Options (Work Pending) Window Description

2352A.bmp

(Box) Select to enable the system to automatically rerun cancelled patient and control tests.

3.

4.

Select the Rerun cancelled tests automatically box to enable the automatic rerun feature, or clear the box to disable the automatic rerun feature.

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

Sample

Container Bar

Code Labels

Use this procedure to attach a bar code label on a sample container.

WARNING

You will come in contact with potentially infectious materials during this procedure. Handle and dispose of biohazard materials according to proper laboratory procedures. Proper hand, eye, and facial protection is required.

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.

3-40

1

2

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

2199A.eps

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UniCel DxI Operator's Guide 3.4: Loading and Unloading Racks

Placing

Sample

Containers in

Racks

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

WARNING

You will come in contact with potentially infectious materials during this procedure. Handle and dispose of biohazard materials according to proper laboratory procedures. Proper hand, eye, and facial protection is required.

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.

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3.4: Loading and Unloading Racks UniCel DxI Operator's Guide

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 .

1

1

2

3

4

3

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.

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Using Insert

Cups with

Sample Tubes

An insert cup has a smaller dead volume than a sample tube. You may need to transfer sample from a sample tube to an insert cup to meet the total sample volume required for testing.

Use this procedure if you are using an insert cup on the instrument.

WARNING

You will come in contact with potentially infectious materials during this procedure. Handle and dispose of biohazard materials according to proper laboratory procedures. Proper hand, eye, and facial protection is required.

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.

3.

Place the insert cup back into the original sample tube.

Place the sample tube into a rack. For more information, see the Placing Sample

Containers in Racks procedure.

1

2

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1 Insert cup

2 Sample tube

Figure 3-14 Loading an Insert Cup

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3-43

3.4: Loading and Unloading Racks UniCel DxI Operator's Guide

Loading a

Rack for

Routine

Processing

Use this procedure to load a rack containing routine samples onto the instrument. If

you are loading a rack containing STAT samples, see the Loading a STAT Rack

procedure. You load racks onto the onload area of the SPU.

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.

• 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:

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

ROUTINE

LOAD

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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3.4: Loading and Unloading Racks UniCel DxI Operator's Guide

7

4

6

3

2

5 1

510

2

4

3

1

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

2150B.eps

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.

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UniCel DxI Operator's Guide 3.4: Loading and Unloading Racks

Place the sample containers for the requested tests in a rack

Check the status of the sample presentation unit

(SPU) cover sensor

Is the sensor off?

No

Select the Routine button 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

Figure 3-17 Loading a Rack for Routine Processing Flowchart

3000C.wmf

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3.4: Loading and Unloading Racks

Loading a

STAT Rack

UniCel DxI Operator's Guide

Use this procedure to load a rack that contains a STAT sample. You can load a STAT rack ahead of racks previously loaded for routine sample processing.

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.

• 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

Calibration Screen topic in Section 5.1: Assay Calibration Overview.

• Do not load a rack while the utility routine is running.

System Mode:

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.

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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 (if equipped) 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.

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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

Rack

After each sample in a rack is aliquoted, the system moves the rack to the offload area 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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UniCel DxI Operator's Guide 3.4: Loading and Unloading Racks

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

WARNING

You will come in contact with potentially infectious materials during this procedure. Handle and dispose of biohazard materials according to proper laboratory procedures. Proper hand, eye, and facial protection is required.

System Mode: Any Mode

1.

Check the front and side offload areas for racks.

3

2

1

5

4

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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

2151A.eps

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3.4: Loading and Unloading Racks UniCel DxI Operator's Guide

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

Sample

Status

UniCel DxI Operator's Guide

You can monitor the status of individual samples in the Status column on the In

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

No Tests

Requested

Aspirated

Supply Wait

In Progress

*Done*

Done

Definition

There is no test request for the sample.

There is a test request for the sample.

The system removed a sample aliquot for processing.

The system requires supplies, a calibration, or an enabled pipettor before it can process the test requests.

The system is processing the requested tests.

The system completed processing the tests, but at least one test was cancelled.

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

Requested

Supply Wait

In Progress

Cancelled

Description

There is a test request for the sample.

The test requires supplies, a calibration, or an enabled pipettor before it can be run.

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

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

Test Requests on a Rack

Use this procedure to cancel the test requests in a manually entered rack that has not been scanned.

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.

3.

Select Edit Request F2 to display the rack on the Test Requests screen.

Select Cancel Request F6 .

A confirmation window is displayed.

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

Manual Test

Request

Use this procedure to edit a manual test request for a patient sample in a rack that has not been scanned.

System Mode: Any Mode

1.

From the Requested view of the Sample Manager screen, select the rack that contains the test requests that you intend to edit.

 (Optional) From the Daily view, select an individual sample from the rack that contains the test requests that you intend to edit.

2.

Select Edit Request F2 to display the rack on the Test Requests screen.

3.

Select the sample position that you intend to edit.

4.

Edit any of the information in the following fields:

• Rack ID

• Sample ID

• Patient ID or Lot Number

• Dilution

• Sample Type

• STAT

• Comment

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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UniCel DxI Operator's Guide 3.6: Editing Test Requests

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

Done editing the rack?

No

Yes

Test Requests

Exit the Test Request screen to save changes

Figure 3-22 Editing a Manual Test Request Flowchart

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3.6: Editing Test Requests UniCel DxI Operator's Guide

Deleting a

Sample from the Test

Requests

Screen

When you delete a manually entered sample from the Test Requests screen, all of the sample information for the container is deleted from the screen. You can delete a sample until the system scans its sample container.

Use this procedure to delete a manually entered sample from the Test Requests screen.

System Mode: Any Mode

1.

From the Requested view of the Sample Manager screen, select the rack that contains the test requests that you intend to delete.

 (Optional) From the Daily view, select an individual sample from the rack that contains the test requests that you intend to delete.

2.

Select Edit Request F2 to display the rack on the Test Requests screen.

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 .

4.

Exit the Test Requests screen to save your changes.

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UniCel DxI Operator's Guide

Sample Manager

From the Requested view, select the rack that contains the sample that you intend to delete

Edit Request F2

Test Requests

3.6: Editing Test Requests

Deleting all samples in the rack?

No

Yes

Clear All Samples F7

Test Requests

Exit the Test Request screen to save changes

Select the sample that you intend to delete

Delete Sample F2

Yes Done deleting samples?

No

2098C.svg

Figure 3-23 Deleting a Sample from the Test Requests Screen Flowchart

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3.6: Editing Test Requests UniCel DxI Operator's Guide

Changing a

Rack ID

Use this procedure to change a rack ID for a manually entered rack.

NOTE

You cannot use a rack ID that is assigned to another rack in the onload area of the

SPU.

System Mode: Any Mode

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] .

6.

Exit the Test Requests screen to save your changes.

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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

Unexpected

Patient Sample

Results

Use the following table to troubleshoot patient sample results that do not seem correct.

Possible Causes Corrective Action

Incorrect patient sample type

Incorrect sample dilution

Patient sample handled incorrectly

Microclots present in the serum sample

Quantity of patient sample not sufficient for testing (QNS result flag and event)

Expired reagent pack

Reagent pack unstable or contaminated due to improper handling

Refer to the reagent instructions for use for the appropriate sample types for each assay.

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.

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.

1. Spin the sample again or use a serum filter to separate the serum from any microclots.

2. Repeat the test.

1. Calculate the correct volume of patient sample needed for the number of replicates and type of

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.

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.

1. Unload the reagent pack and load a new reagent

pack (see Section 2.7).

• 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

Possible Causes

Expired assay calibration

Quality controls (QC) not run after preventive maintenance or repair

Partial bottles of substrate combined

Routine maintenance not performed

Wrong sample container and/or rack

Sample container missing or placed in incorrect position in the rack

Contaminated substrate supply

Corrective Action

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.

1. Run QC.

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.

1. Change the in-use substrate bottle and prime the

substrate (see Section 2.2).

2. Repeat the test

1. Perform maintenance (see Section 7.1).

2. Repeat the test.

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 ).

1. Be sure that the sample containers are in the proper order in the rack.

2. Repeat the test.

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

Patient Sample

Results with

Increased

Variability

Use the following table to troubleshoot patient sample results that demonstrate poor precision, value shifts, or values that increase over the course of a run.

Possible Causes Corrective Action

Expired reagent pack

Expired assay calibration

Quality controls (QC) not run after preventive maintenance or repair

Routine maintenance not performed

Wash buffer contaminated

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.

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.

1. Run QC.

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.

1. Perform maintenance (see Section 7.1).

2. Repeat the test.

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

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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

4-1

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)

Is the result flagged?

No

Yes

View details and troubleshoot

(Optional)

Archive, delete, or print results

(Optional)

Archive, delete, or print results

Figure 4-1 Test Results Overview Flowchart

Test Results

Screen

Use the Test Results screen to:

• View or print test results

• Troubleshoot test results with flags

• Rerun a test

• Manage results manually

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Filter

Entries

Selected Result

2036B.bmp

(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.

(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.

(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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4.1: Test Results Overview

Patient ID

Sample ID

Rack

Test Name

Result

Pipettor

Flags

UniCel DxI Operator's Guide

(Optional column) Displays the patient ID, if one exists, for the patient sample.

(Required column) Displays the sample ID that is associated with the result.

(Optional column) Displays the number of the rack that the sample is in.

(Required column) Displays the test name that is associated with the 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.

(Optional column) Displays the reagent pipettor on which the test was run.

(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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UniCel DxI Operator's Guide 4.1: Test Results Overview

LIS

Rgt. Lot

Pack S/N

RLU

Comp. Time

(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 .

(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.

(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.

(Optional column - not shown) Displays the RLUs for the test result.

(Optional column - not shown) Displays the date and completion time of the test.

Figure 4-2 Test Result Screen Descriptions (continued)

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4.1: Test Results Overview UniCel DxI Operator's Guide

Verify

Instrument

Filter

F1

Find

F2

Rerun Test

F3

Sample Details

F4

Send to LIS

F5

Copy to Disk

F6

(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.

(Optional column - not shown) Displays the ID of the instrument on which the test was run.

(Button) Select to apply, edit, or delete test result filters. The system displays the selected filter and sort order in the Filter

field. For more information, see

Section 4.2: Test Result Filters.

(Button) Select to search the filtered results for a specific test result. For more

information, see the Finding a Test Result procedure in Section 4.3: Reviewing Test

Results.

(Button) Select to run the selected test again. If sufficient sample to rerun the test 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.

(Button) Select to display sample related patient demographic information, comments 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.

(Button) Select to send test results to the LIS. For more information, see the Sending

Test Results to the LIS procedure in Section 4.4: Managing Test Results.

(Button) Select to copy all test results or the selected test results to a disk. For more

information, see the Copying Test Results to a Disk or Flash Drive procedure

in Section 4.4: Managing Test Results.

Figure 4-2 Test Result Screen Descriptions (continued)

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UniCel DxI Operator's Guide 4.1: Test Results Overview

Print

F7

More Options

F8

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

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.

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

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.

Figure 4-2 Test Result Screen Descriptions (continued)

Refreshing the Test

Results

Screen

When a plus sign (+) is displayed in the Entries field of the Test Results screen, refresh the screen.

System Mode: Any Mode

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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4.1: Test Results Overview UniCel DxI Operator's Guide

Configuring the Test

Results

Screen

Use this procedure to add or rearrange result information on the Test Result screen.

The Sample ID , Test Name , Result , and Flags columns are required, but you can change their order on the 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.

System Mode: Any Mode

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

Column Order

0602A.bmp

(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

(Buttons) Select the right or left Arrow button to rearrange a selected column in the

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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UniCel DxI Operator's Guide 4.1: Test Results Overview

2.

3.

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.

Select OK F1 .

The Test Result screen displays the columns in the order you selected.

Selecting Test

Results

Select individual results to limit the data that prints on a report, to rerun a specific test, 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.

System Mode: Any Mode

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.

2.

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.

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

Test Result

Filter

Use this procedure to apply one of the available test result filters.

The following test result filters are system defined:

Filter 1st Sort

All Flagged Test Results (Last 30 days) Sample ID

All Patient Samples (Last 30 days) Sample ID

All Patient Samples Loaded Between...

Completion Time

All Samples (Last 30 days)

All Samples Loaded Between...

Sample ID

Completion Time

Failed Auto-Verify and Not Sent to LIS Sample ID

LIS Transmission Failed Sample ID

On-board Patient Samples

On-board Samples

On-board STAT Samples

Sample ID

Sample ID

Sample ID

2nd Sort

Test Name

Test Name

Test Name

Test Name

Test Name

Test Name

Test Name

Test Name

Table 4-4 Test Result Filters and Default Sort Orders

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System Mode: Any Mode

1.

From the Test Results screen , select Filter F1 .

UniCel DxI Operator's Guide

Filter

1st Sort Order

2nd Sort Order

Ascending

Description

New Filter

F2

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(List) Displays a list of available system-defined and laboratory-defined filters.

(Option) Select to change the primary sort order. The default sort order depends on

the filter (see Table 4-4).

(Option) Select to change the secondary sort order. The default sort order depends

on the filter (see Table 4-4).

(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.

(Field) Displays a description of the selected filter.

(Button) Select to define a new filter.

Figure 4-5 Filter (Test Results) Window Descriptions

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Edit Filter

F3

Delete Filter

F4

(Button) Select to edit the parameters of the selected filter. You can then save the changes as a new filter or apply the edited filter without saving it.

(Button) Select to delete the laboratory-defined filter selected in the Filter list.

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

Editing a Test

Result Filter

Use this procedure to define a new filter or edit an existing filter and apply it to the

Test Results screen.

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.

System Mode: Any Mode

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.

Filter Name

Description

0605B.bmp

(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.

(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 &

Time

Instruments

(Box) Select to have the system ask for date and time parameters each time you apply the filter.

(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

Test Name

Auto-Verify

Rack ID

Patient ID

Result

(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 .

(List) Select the enabled tests to include in the filter. The list contains all enabled test names.

(List) Select the status of the test results to include in the filter.

Values are: unverified , pass , fail , or all results.

(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.

(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.

(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

.

Population

OK

F1

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

.

(Boxes) Select one or more of the result populations to include in the filter.

(Button) Select to save the edited filter with the same name and overwrite the 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

F2

Clear Parameters

F3

(Button) Select to save the edited filter as a new filter with a new name. For laboratory-defined filters, you can keep the same name and overwrite the previous filter. When you save the filter, it is applied.

(Button) Select to clear all of the fields and reset the parameters to the current filter 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

Save the filter?

Yes

No

No F4

Specify the date and time (if required), the system applies the filter, but does not save it

Yes F1

Specify the date and time (if required), then give the filter a name

OK F1

The system saves and applies the filter

Figure 4-7 Defining or Editing a Test Result Filter Flowchart

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Deleting a

Test Result

Filter

Use this procedure to delete laboratory-defined filters. You cannot delete system-defined filters.

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 information, see Section 3.4: Ranges Setup in the Reference Manual .

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Finding a Test

Result

Use this procedure to find a specific test result on the Test Result screen.

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.

System Mode: Any Mode

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.

Sample ID

Rack ID

0609A.bmp

(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.

(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

Test Name

Direction

Find Next

F1

(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.

(List) Select from a list of test names or enter a test name to find a result using only its test name.

(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.

(Button) Select to find the next result that matches the information in the field.

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 found?

No

Yes

Cancel F8

Figure 4-9 Finding a Test Result Flowchart

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Viewing

Sample

Details

4.3: Reviewing Test Results

Use this procedure to view explanations about result flags or details about the sample a result is associated with, including demographic information and comments.

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 .

Patient ID

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(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

Last Name

Sex

Birth Date

Doctor Name

Sample ID

Sample Type

Offboard Dilution

Onboard Dilution

Test Name

Reference Range

(Field) Displays the first name of the patient. This information is sent from the LIS.

(Field) Displays the last name of the patient. This information is sent from the LIS.

(Field) Displays the sex of the patient. This information is sent from the LIS.

(Field) Displays the birth date of the patient. This information is sent from the LIS.

(Field) Displays the name of the patient's doctor. This information is sent from the

LIS.

(Field) Displays the sample ID.

(Field) Displays the type of fluid in the sample container.

(Field) Displays the dilution factor for sample dilutions prepared manually.

(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 .

(Field) Displays the name of the test that was run on the patient sample.

(Field) Displays the reference range used to evaluate the test. For more information, see Section 3.4: Ranges Setup in the Reference Manual .

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.

(List) Displays any flags associated with the result and a description of each flag.

Flags

Troubleshoot

F2

(Button) Displays troubleshooting Help about flags.

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

Flags and

Troubleshooting

The following tables provide troubleshooting information associated with test result flags that are fatal (no calculated result) or non-fatal (calculated result, but a condition exists for that result). Use the information to identify and correct assay related problems. This information is also provided online when you select Troubleshoot F2

from the Sample Details window. For more information, see the Viewing Sample

Details procedure.

Fatal Flag

AEX

CCR

Description

The aliquoted sample cannot be used for one or more of the following reasons:

• An error occurred when the aliquot was dispensed into the vessel.

• The aliquot has been on board the instrument for up to three hours and has expired.

• The last test taken from the aliquot was completed one hour ago.

A result could not be calculated because:

• One of the tests included in a derived result formula (see

Section 3.6: Derived Result Setup in the Reference Manual ) did not produce a result.

• A confirmatory test result could not be calculated. Usually this occurs because the samples for the qualitative and confirmatory tests were not aspirated at the same time

(see Section 1.5: Confirmatory

Assay Theory in the Reference

Manual ).

• Another error prevented the system from calculating a result.

Corrective Action

1. Review the Event Log for error events with a similar date and time to this event (see Section 5.2 in the

Reference Manual ). If events are found, troubleshoot according to available information or contact Technical

Support.

2. Make sure that required supplies are on board before running the test again.

3. Check the test status in the Result column of the Test

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.

1. Take one of the following actions:

• For results other than derived results, skip to step 2.

• For derived results, review each test result used in the derived result formula. If a result failed, troubleshoot according to the flag for that result.

2. Review the Event Log for error events with a similar date and time to this event (see Section 5.2 in the

Reference Manual ). If events are found, troubleshoot according to available information or contact Technical

Support.

3. Repeat the test.

• For a derived result, repeat all tests included in the derived result formula.

• For a confirmatory result, repeat the confirmatory and qualitative tests.

Table 4-11 Fatal Flags

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Fatal Flag

CLT

IND

Description

An obstruction was detected in the sample tube before aliquoting or in the RV during processing.

• For sandwich assays, which use positive slope calibration curves, the result is at the low end of the concentration curve and cannot be distinguished from a system failure because the RLU reading is too low .

• For competitive assays , which use negative slope calibration curves, the result is at either:

• The high end of the concentration curve and cannot be distinguished from a system failure because the

RLU reading is too low , or

• The low end of the concentration curve and cannot be distinguished from a system failure because the

RLU reading is too high .

Corrective Action

Check the test status in the Result column of the Test Result screen.

• 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.

5. If the problem persists, contact Technical Support.

1. For IND flagged results which meet the following criteria, dilute and rerun the sample:

• The result is on a competitive assay, and

• Sample dilution is allowed for the assay, and

• The sample RLU is low .

See the reagent instructions for use to determine the assay type and whether sample dilution is allowed.

2. Rule out a system problem by reviewing the Event Log for error events with a date and time shortly before this event. Troubleshoot accordingly.

3. If you have ruled out a system problem and the IND flag event is the only issue, recalibrating the affected assay may resolve the problem.

• Recalibrate the assay using a new reagent pack and a new set of calibrators.

• 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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Fatal Flag

NCR

QNS

Description

No calibration data existed for the reagent lot when the patient or QC result was processed.

The sample volume is insufficient in the sample container or in the RV during processing.

If the flag is applied because of insufficient volume in the RV, and

Automatic Rerun is enabled, the test will be reordered. Otherwise, additional tests will not be scheduled for this sample.

Tests already scheduled will be completed.

Corrective Action

1. Calibrate the assay (see Section 5.3).

2. Repeat the test.

Check the test status in the Result column on the Test Result screen.

• For patient and QC samples with the test status

Requested:

1. Identify event log errors. Contact Technical Support if you need help troubleshooting event log errors (see

Section 5.1 in the Reference Manual ).

2. 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).

3. Load the sample. The test is run automatically.

4. If the problem persists, contact Technical Support.

• For samples with the test status Cancelled:

1. Identify event log errors. Contact Technical Support if you need help troubleshooting event log errors (see

Section 5.1 in the Reference Manual ).

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. 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.

3. Request the test again.

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.

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.

6. If the problem persists, contact Technical Support.

Table 4-11 Fatal Flags (continued)

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Fatal Flag

QSB

QSD

Description

A substrate dispense failure occurred during processing.

Insufficient sample volume or reagent volume was dispensed into an RV.

Corrective Action

1. Prime the substrate (see Section 4.3 in the Reference

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.

- 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.

5. If the problem persists, contact Technical Support.

1. Review the Event Log. Contact Technical Support if you need help troubleshooting event log errors (see

Section 5.1 in the Reference Manual ).

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.

5. If the problem persists, contact Technical Support.

Table 4-11 Fatal Flags (continued)

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Fatal Flag

QSS

RLU

Description

An insufficient volume of sample or reagent was withdrawn for the test.

The relative light units (RLUs) are outside the acceptable luminometer measuring range.

Corrective Action

1. Review the Event Log. Contact Technical Support if you need help troubleshooting event log errors (see

Section 5.1 in the Reference Manual ).

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.

5. If the problem persists, contact Technical Support.

1. Review the Event Log. Contact Technical Support if you need help troubleshooting event log errors (see

Section 5.1 in the Reference Manual ).

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.

5. If the problem persists, contact Technical Support.

Table 4-11 Fatal Flags (continued)

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Fatal Flag

SYS

TRI

Description Corrective Action

A device error occurred during processing.

1. Review the Event Log. Contact Technical Support if you need help troubleshooting event log errors (see

Section 5.1 in the Reference Manual ).

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.

5. If the problem persists, contact Technical Support.

The temperature of the analytical module was outside the acceptable limits when the test was being incubated.

1. Check the wash carousel temperature on the

Maintenance Review screen. If the temperature is 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.

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.

5. If the temperature does not normalize, or if the problem persists, contact Technical Support.

Table 4-11 Fatal Flags (continued)

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Fatal Flag

TRS

TRW

Description

The temperature of the substrate was outside the acceptable limits when the substrate was dispensed.

The temperature of the analytical module was outside the acceptable limits when the reaction vessel was in the wash carousel.

Corrective Action

1. Check the substrate temperature on the Maintenance

Review screen. If the temperature is outside the 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.

• 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 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.

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.

5. If the temperature does not normalize, or if the problem persists, contact Technical Support.

1. Follow the corrective actions provided for the TRI flag.

Table 4-11 Fatal Flags (continued)

Non-Fatal Flag

CEX

Description

The calibration curve or cut-off value is expired.

Corrective Action

1. Recalibrate the assay (see Section 5.3).

2. Repeat the test.

Table 4-12 Non-Fatal Flags

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Non-Fatal Flag

CLX

CRH

CRL

DEX

EXS

GRY

Description

The calibrator lot is expired.

Note: For patient and QC tests, the calibrator lot may have expired after a successful calibration.

Corrective Action

• For patient and QC tests: Review the Calibration

Data screen to determine whether replicates of the active calibration are associated with the CLX flag

(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.

This is a valid test result. No corrective action is necessary.

This is a valid test result. No corrective action is necessary.

1. Make sure sufficient unexpired diluent is available

(see Section 2.7).

2. Repeat the test.

The patient test result is above the upper limit of the critical range.

The patient test result is below the lower limit of the critical range.

The open pack stability time has expired for the diluent pack. The system measures open pack stability separately by well.

Note: For an LIS attached to a DxI instrument, the PEX flag is sent to the LIS in place of the DEX flag.

The substrate is expired.

For qualitative assays, the patient or QC result is within the specified gray zone., also known as the equivocal zone.

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.

This is a valid test result. No corrective action is necessary.

In some cases, the GRY flag may be applied to a result with an S/CO value which appears to be at the upper or lower limit of the gray zone, so would not be expected to be in the gray zone. You may also observe multiple results with the same S/CO, some of which have the

GRY flag and some of which do not. This is because the GRY flag is applied before the final rounding of the S/CO to two decimal places. If your laboratory prefers to avoid these situations, contact Technical

Support for instructions on setting the gray zone limits.

Table 4-12 Non-Fatal Flags (continued)

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Non-Fatal Flag

LEX

LOW

LRH

LRL

ORH

ORL

Description

The patient or QC result is lower than the minimum reportable result value defined in the APF.

Corrective Action

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.

No corrective action is necessary.

The patient result is above the upper limit of the LIS range.

Notes:

• If the Auto-Send to LIS option is set to

Verify , the system does not automatically send results with this flag to the LIS.

• This flag is for quantitative assays, semi-quantitative assays, and derived results only.

The patient result is below the lower limit of the LIS range.

Notes:

• If the Auto-Send to LIS option is set to

Verify , the system does not automatically send results with this flag to the LIS.

• This flag is for quantitative assays, semi-quantitative assays, and derived results only.

The patient result is above the upper limit of the reference range.

The patient result is below the lower limit of the reference range.

1. Review the result.

2. Take one of the following actions:

• Send the result to the LIS manually (see

Section 4.4).

• Delete the result (see Section 4.4) and repeat the

test.

1. Review the result.

2. Take one of the following actions:

• Send the result to the LIS manually (see

Section 4.4).

• Delete the result (see Section 4.4) and repeat the

test.

No corrective action is necessary.

No corrective action is necessary.

Table 4-12 Non-Fatal Flags (continued)

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Non-Fatal Flag

OVR

PEX

QCF

QEX

RFX

Description

The calculated concentration is above the highest or most concentrated calibrator.

This flag is only used for quantitative and semi-quantitative assays.

The open pack stability time has expired for the reagent pack. The system starts measuring open pack stability when it first punctures the pack.

Note: For an LIS attached to a DxI instrument, the PEX flag is sent to the LIS in place of the DEX flag.

The quality control result violates one or more QC rules.

Corrective Action

1. Review the Event Log for error events with a similar date and time to this event (see Section 5.2 in the Reference Manual ).

• 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.

1. 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.

2. Repeat the test.

The quality control lot is expired.

The patient sample result is from a reflex test.

1. Display the QC Chart and Data screen to review which criteria is not met.

2. Follow the QC troubleshooting instructions (see

Section 6.7).

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.

No corrective action is necessary for this flag alone.

Table 4-12 Non-Fatal Flags (continued)

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Non-Fatal Flag

TRA

TRR

Description

The temperature of the sample wheel was outside the acceptable limits when the sample aliquot was in the sample wheel.

The temperature of the reagent storage chamber was outside the acceptable limits when reagents were pipetted.

Corrective Action

1. Check the sample wheel temperature on the

Maintenance Review screen (see Section 7.1). If

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.

• 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 sample wheel temperature is within the acceptable limits, repeat the test.

3. If the temperature does not normalize, or if the problem persists, contact Technical Support.

1. Check the reagent storage chamber temperature on

the Maintenance Review screen (see Section 7.1).

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.

• 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 reagent storage chamber temperature is within the acceptable limits, repeat the test.

3. If the temperature does not normalize, or if the problem persists, contact Technical Support.

Table 4-12 Non-Fatal Flags (continued)

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Rerunning a

Patient Test

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

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.

System Mode: Any Mode

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.

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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.

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Copying Test

Results to a

Disk or Flash

Drive

Use this procedure to copy test results to a USB flash drive or a 3.5-inch high density disk.

The UniCel DxI system writes test result data into a comma-separated field format that can be imported into a PC-based spreadsheet program. The following data is presented in the order indicated:

1. Patient ID

4. Verify

7. Result

10. Flags

2. Sample ID

5. Test name

8. Units

11. LIS

3. Rack

6. Interpretation

9. Comp. time

12. Instrument

13. RLU

16. Sample priority

14. Pipettor

17. Test ID

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

15. Sample type

18. Reag. pack lot 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:

1.

Ready Not Ready

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.

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File Name

Drive

Current

Result

2107B.bmp

(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.

(List) Select the drive to which data should be copied.

(Option) Select to copy one selected test result to the storage media.

Figure 4-13 Copy to Disk (Test Results) Window Descriptions

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4.4: Managing Test Results UniCel DxI Operator's Guide

Current

Selection

All (filtered results)

Format Disk

(Option) Select to copy one or more selected test results to the storage media.

(Option) Select to send all the test results in the current filter to the storage media.

(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.

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Test Results

UniCel DxI Operator's Guide

Are results to be copied displayed?

Yes

No

Insert a 3.5-inch disk into the disk drive or a USB flash drive into the USB port

(Optional)

Select one or more results

Do you want a specific result?

No

Yes

Find F2

Find

Enter one of the four options

Find Next F1

Filter F1

Filter

Apply filter and sort orders

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

Figure 4-14 Copying Test Results to a Flash Drive or Disk Flowchart

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UniCel DxI Operator's Guide 4.4: Managing Test Results

Sending Test

Results to the

LIS

Use this procedure to manually send test results to the LIS if one or more of the following circumstances applies:

• 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.

System Mode: Any Mode

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

Section 4.2: Test Result Filters.

 (Optional) To locate a specific test result to send, select Find F2 . For more

information, see the Finding a Test Result procedure in Section 4.3: Reviewing

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.

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3.

Select Send to LIS F5 .

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4-46

(Option) Select to send one selected test result to the LIS.

2108A.bmp

Current

Result

Current

Selection

Resend LIS

Fail

All (filtered results)

(Option) Select to send one or more selected test results to the

LIS.

(Option) Select to resend all of the test results with an LIS status of Fail in the current filter to the LIS.

(Option) Select to send all the test results in the current filter to 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.

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UniCel DxI Operator's Guide 4.4: Managing Test Results

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 displayed?

Yes

No

(Optional)

Select one or more results

Send to LIS F5

Send to LIS

Select a Send What option.

OK F1

Do you want a specific result?

No

Yes

Find F2

Find

Enter one of the four options

FInd Next F1

Monitor transmission

Figure 4-16 Sending Test Results to the LIS Flowchart

Filter F1

Filter

Apply filter and sort orders

OK F1

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4.4: Managing Test Results UniCel DxI Operator's Guide

Deleting a

Test Result

Use this procedure to delete patient and QC test results from the database.

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:

1.

Ready Not Ready

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

information, see the Finding a Test Result procedure in Section 4.3: Reviewing

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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Test Results

4.4: Managing Test Results

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.

Are results

to be deleted displayed?

No

Yes

(Optional)

Select one or more results

Do you want a specific result?

No

Yes

Find F2

Find

Enter one of the four options

FInd Next F1

More Options F8

Delete Data F3

Password

Enter your password

OK F1

Delete Data

Select option from

Delete What list

OK F1

Figure 4-17 Deleting a Test Result Flowchart

Filter F1

Filter

Apply filter and sort orders

OK F1

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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.

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UniCel DxI Operator's Guide 4.5: Test Result Reports

Test Result

Report

Descriptions

Four test result reports are available on the UniCel DxI system.

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 .

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4.5: Test Result Reports UniCel DxI Operator's Guide

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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UniCel DxI Operator's Guide 4.5: Test Result Reports

Sample Report

UniCel DxI 800, Access Immunoassay System

S/N 610240

Sample ID:

Patient ID:

Name:

Sex:

Birth date:

**STAT**

Instrument: 501240

Test Name

CK-MB

MYO

MYO(2)

23345128

555-56-9898

Follett F.

Male

10-15-1944

Result

>293 ng/mL

No Value

39.6

ng/mL

Instrument: 501240

Test Name

FreePSA% freePSA

PSA-Hyb

02:15 PM

Comments: Cloudy sample.

Result

16.6

1.58 ng/mL

9.53 ng/mL

Laboratories, Inc.

Laboratory A

123 Lake Street

Townsville, ST 33333

101-555-2323 ext. 109

Ref. Range

0.6-6.3

17.4-105.7

17.4-105.7

Ref. Range

0.000-4.000

Flags

OVR

QNS

Flags

Sample Type:

Dilution

1

1

1

Dilution

1

B. Beaulieu

Serum

Completed

10-10-02 07:30 PM

10-10-02 07:27 PM

10-10-02 07:16 PM

Completed

08-08-02 02:45 PM

1 08-08-02

OVR = Over range, QNS = Insufficient Sample

Technologist _____________________________________

Figure 4-18 Sample Report Example

Page 1 of 1

Printed 10-10-02 10:28 PM

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4.5: Test Result Reports UniCel DxI Operator's Guide

Patient Report

UniCel DxI 800, Access Immunoassay System

S/N 610240

Patient ID:

Name:

555-56-9898

Feldmann, A.

Sex: Male

Birth Date: 10-15-1944

**STAT**

Sample ID:

Test Name

23345128Dil

Result

CK-MB 939.0 ng/mL

Comments: Sample slightly cloudy.

**STAT**

Sample ID:

Test Name

CK-MB

MYO

MYO(2)

23345128

Result

>293 ng/mL

No Value

125.8 ng/mL

Sample ID:

Test Name

FreePSA% freePSA

423005160

Result

16.6

1.58 ng/mL

PSA-Hyb 9.53 ng/mL

Comments: Copy of results to Dr. Bennett.

Sample ID:

Test Name

PSA-Hyb(2)

PSA-Hyb

423000204

Result

3.71 ng/mL

3.86 ng/mL

Laboratories, Inc.

Laboratory A

123 Lake Street

Townsville, ST 33333

101-555-2323 ext. 109

Sample Type:

Ref. Range

0.5-5.0

Sample Type:

Ref. Range

0.5-5.0

14.3-65.8QNS

14.3-65.8ORH

Sample Type:

Ref. Range

0.000-4.000

Sample Type:

Ref. Range

0.000-4.000

0.00-4.000

Plasma

Flags

ORH

Serum

Flags

Plasma

Flags

OVR

1

Serum

Flags

ORH

R. Goldman

Dilution: 10

Completed

10-10-02 08:18 PM

Completed

10-10-02 07:30 PM

10-10-02 07:27 PM

0-10-02 07:27 PM

Completed

08-08-02 02:44 PM

08-08-02 02:45 PM

08-08-02 02:15 PM

Completed

02-02-02 12:03 PM

02-02-02 11:15 AM

OVR = Over range, QNS = Insufficient Sample

Technologist ____________________________________

Figure 4-19 Patient Report Example

Page 1 of 1

Printed 10-10-02 10:25 PM

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UniCel DxI Operator's Guide 4.5: Test Result Reports

Filter:

Sample ID

13501350

13501350

13501350

19953581

19953581

23345128

23345128

23345128

25688888

39422493

78910116

Selected Test Results ReportUniCel DxI 800,

Access Immunoassay System

S/N 610240

Laboratories, Inc.

Laboratory A

123 Lake Street

Townsville, ST 33333

101-555-2323 ext. 109

V. Flores

All Samples - Sorted by Sample ID Then by Test Name

106

106

48

505

502

Rack

48

48

48

504

504

106

Test Name Result

Ferritin

FOL2

404.1 ng/mL

4.34 ng/mL

VitB12 freePSA

PSA-Hyb

CK-MB

MYO

MYO(2)

VitB12

MYO

FOL2

354 pg/mL

Supply Wait

39.6

ng/mL

No Value

103 pg/mL

0.00 ng/mL

Cancelled

Flags LIS

SYS

Accepted 1

Accepted 3

Accepted 4

1

Supply Wait 3

>293 ng/mL OVR Accepted 4

Accepted 2

QNS Accepted 1

Failed

Failed

Pipettor

2

2

3

Comp. Time

10/10/02 06:40

10/10/02 06:32

10/10/02 06:38

10/10/02 19:30

10/10/02 19:27

10/10/02 19:27

10/10/02 06:41

10/10/02 14:03

10/10/02 10:46

OVR = Over range, QNS = Insufficient sample, SYS = System error

Technologist ________________________________

Page 1 of 1

Printed 10/10/02 20:07

Figure 4-20 Selected Test Results Report Example

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4.5: Test Result Reports UniCel DxI Operator's Guide

4-56

2042B.bmp

Figure 4-21 Continuous Sample Report Example

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UniCel DxI Operator's Guide 4.5: Test Result Reports

Printing Test

Result

Reports

Use this procedure to print a test result report.

NOTES

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.

System Mode: Any Mode

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

information, see the Finding a Test Result procedure in Section 4.3: Reviewing

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 .

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4.5: Test Result Reports UniCel DxI Operator's Guide

Report

Current

Result

Current

Selection

All (filtered results)

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

(Option) Select to print one selected test result.

(Option) Select to print one or more selected test results.

(Option) Select to print all the test results on the current Test

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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UniCel DxI Operator's Guide

Test Results

4.5: Test Result Reports

Are results

to be printed displayed?

No

Yes

(Optional)

Select one or more results to print

Print F7

Report F1

Print

Select a report and a

Print What option

Do you want a specific result?

No

Yes

Find F2

Find

Enter one of the four options

FInd Next F1

OK F1

Figure 4-23 Printing Test Result Reports Flowchart

Filter F1

Filter

Apply filter and sort orders

OK F1

2071B.wmf

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4.5: Test Result Reports UniCel DxI Operator's Guide

Printing the

Continuous

Sample

Report

Use this procedure to manually print the Continuous Sample Report. For a description

of the Continuous Sample report, see the Test Result Report Descriptions topic.

Most operators will wait for the Continuous Sample Report to print automatically. To 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.

System Mode: Any Mode

1.

From the Test Results screen, select Print F7 .

2.

Select Completed Samples F2 .

The system sends the report to the printer.

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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

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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

5-2 © 2022 Beckman Coulter, Inc.

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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 (if equipped)

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 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.

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5.1: Assay Calibration Overview UniCel DxI Operator's Guide

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 calibration pass?

Yes

No

Review calibration data and troubleshoot

Use the calibration to process samples

Repeat calibration before it expires

Figure 5-1 Assay Calibration Overview Flowchart

2127C.wmf

5-4 © 2022 Beckman Coulter, Inc.

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UniCel DxI Operator's Guide 5.1: Assay Calibration Overview

Calibration

Screen

Use the Calibration screen to:

• Add and delete calibrator lots or edit calibrator levels

• View, print, or delete calibration data

• Print a calibration report

Filter

Entries

Assay Buttons

Filter

F1

2128B.bmp

(Field) Displays the applied filter and sort order.

(Field) Displays the total number of calibrations that meet the filter parameters.

(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.

(Button) Select to apply a different calibration filter or to change the sort order. For

more information, see the Applying a Calibration Filter procedure.

Figure 5-2 Calibration Screen Descriptions

© 2022 Beckman Coulter, Inc.

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5.1: Assay Calibration Overview UniCel DxI Operator's Guide

Review Data

F2

Calibrator Setup

F5

Delete

F6

Print

F7

(Button) Select to review the Calibration Data screen for a selected Assay button.

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.

(Button) Select to display the Calibrator Setup screen. From this screen, you can

set up, edit, or delete calibrators. For more information, see Section 5.2: Setting Up

Calibrators.

(Button) Select to delete a selected calibration and its Assay button. All of the calibration data for the selected test and reagent lot is removed from the system.

For more information, see the Deleting Calibrations procedure.

(Button) Select to print the Calibration Report, which lists assay calibrations

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

Calibration

Filter

Use this procedure to apply a different filter or sort order to the Assay buttons on the

Calibration screen.

System Mode: Any Mode

1.

From the Calibration screen, select Filter F1 .

5-6

Filter

0850C.bmp

(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

© 2022 Beckman Coulter, Inc.

C95317-AA

UniCel DxI Operator's Guide 5.1: Assay Calibration Overview

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

Calibrations

Use this procedure to delete the assay calibration data for a specific reagent lot. Delete 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.

System Mode:

1.

Ready Not Ready

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.

3.

Select the Assay button and then select Delete F6 .

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

© 2022 Beckman Coulter, Inc.

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5.1: Assay Calibration Overview UniCel DxI Operator's Guide

Printing the

Calibration

Report

The Calibration Report is a list of assay calibrations, sorted first by test name and then by reagent lot. Use this procedure to print the 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.

5-8 © 2022 Beckman Coulter, Inc.

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UniCel DxI Operator's Guide 5.1: Assay Calibration Overview

Filter:

Test Name

CK-MB

Ferritin

FRT4

FRT4

GToxo

GToxo

IgM-Toxo

IgM-Toxo

MRub

MRub

MYO

Rub-IgG

Rub-IgG

TBhCG2

TBhCG2

TotT3

TSH

TSH

Calibration Report

UniCel DxI 800, Access Immunoassay System

S/N 610240

Laboratories, Inc.

Laboratory A

123 Lake Street

Townsville, ST 33333

101-555-2323 ext. 109

Jane Smith

All Calibrations - Ascending Sorted by Test Name and Reagent Lot

Reagent Lot

900130

000125

000111

012650

022888

044777

059940

098564

091573

963258

055555

011111

988888

021654

085614

002698

074523

987785

Technologist__________________________________________

Page 1 of 1

Printed 03/03/10 12:43 PM

Figure 5-4 Calibration Report Example

2131C.bmp

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5.2: Setting Up Calibrators UniCel DxI Operator's Guide

5-10

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.

© 2022 Beckman Coulter, Inc.

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UniCel DxI Operator's Guide 5.2: Setting Up Calibrators

Calibrator

Setup Screen

Use the Calibrator Setup screen to:

• View calibrator lot and expiration information

• Add and delete calibrator lots or edit calibrator levels

Calibrator List

Add Calibrator

F1

2134B.bmp

(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.

(Button) Select to add a calibrator lot to the system.

Figure 5-5 Calibrator Setup Screen Descriptions

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5.2: Setting Up Calibrators UniCel DxI Operator's Guide

Edit Calibrator

F2

(Button) For quantitative and semi-quantitative assays only. Select to edit the 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 .

(Button) Select to delete a selected calibrator lot and to remove all data associated with it from the system.

Delete Calibrator

F6

NOTE

You need the system password to use this feature.

Figure 5-5 Calibrator Setup Screen Descriptions (continued)

Adding a

Calibrator Lot

Use this procedure to add a calibrator lot to the system for an individual test. If you 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 .

System Mode: Any Mode

1.

From the Calibration screen, select Calibrator Setup F5 .

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UniCel DxI Operator's Guide 5.2: Setting Up Calibrators

2.

From the Calibrator Setup screen, select Add Calibrator F1 to display the Add

Calibrator window.

Bar Code

Calibrator Name

Lot Number

Expiration Date

2162A.bmp

(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).

(Field) Displays the name of the calibrator, based on the bar code entry.

(Field) Displays the calibrator lot number, based on the bar code entry.

(Field) Displays the calibrator expiration date, based on the bar code entry.

Figure 5-6 Add Calibrator Window Descriptions

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5.2: Setting Up Calibrators UniCel DxI Operator's Guide

Calibrator Level

List

(List) Displays the following information for each calibrator level after bar code 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] .

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UniCel DxI Operator's Guide 5.2: Setting Up Calibrators

Calibration

Calibrator Setup F5

Calibrator Setup

When typing bar code information, press [Enter] after each bar code

Add Calibrator F1

Add Calibrator

Scan the calibrator bar code information

Is the calibrator information correct?

Yes

OK F1

No

Figure 5-7 Adding a Calibrator Lot Flowchart

2135B.wmf

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5.2: Setting Up Calibrators UniCel DxI Operator's Guide

Scanning the

Calibrator

Card

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

System Mode: Any Mode

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.

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

Calibrator

Level

5.2: Setting Up Calibrators

Use this procedure to correct a problem with the calibrator level information for a quantitative or semi-quantitative assay.

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 .

System Mode: Any Mode

1.

From the Calibration screen, select Calibrator Setup F5 .

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

Calibrator Lot

Use this procedure to delete a calibrator lot from the system. All data associated with the calibrator lot, including calibrations, is removed from the system.

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 Section 2.2: System Setup in the Reference Manual .

• You cannot delete a calibrator lot that is included in a calibration request.

System Mode:

1.

Ready Not Ready

From the Calibration screen, select Calibrator Setup F5 .

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.

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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

Setup in the Reference Manual .

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.

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5.3: Running a Calibration

Test Requests

Screen for

Calibration

Use the Test Requests screen to:

• Enter calibration request information

• Cancel calibration requests

UniCel DxI Operator's Guide

Rack Button and

Enter ID

Calibrator

Calibrator Lot

2161B.bmp

(Button and Field) Displays the rack ID, and the position and sample ID of each container in the rack.

Select the Rack button to enter or change the rack ID. The Enter ID field is displayed.

(Field) Displays the name of the calibrator selected for this calibration in the

Request Calibration window (see Figure 5-9).

(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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UniCel DxI Operator's Guide 5.3: Running a Calibration

Reagent and

Reagent Lot

(Fields) Displays the reagent name and lot number of the oldest reagent pack on board that is not empty, expired, or included in another calibration request. The 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

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 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

F3

(Button) Select to exit this request and to request a new test request. There are three different test request types.

Patient/QC Requests F1

Select to request tests for patient samples and quality controls. For more

information, see Section 3.3: Patient Test Requests or see Section 6.3: Running

Quality Control Tests.

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

F4

Cancel Request

F6

(Button) Select to display the Test Results screen. The Test Results screen begins to display test requests when the samples are aliquoted by the system. For more

information, see Section 4.3: Reviewing Test Results.

(Button) Select to cancel the test request and to return to the Sample Manager

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

Calibration

Requests

Use this procedure to request a calibration, which can consist of up to seven calibrator samples.

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.

System Mode: Any Mode

1.

From the Sample Manager screen, select New Request F3 and then

Calibration F2 to display the Request Calibration window.

5-22

Calibrator List

2164B.bmp

(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

Figure 5-10 Entering Calibration Requests Flowchart

2101B.wmf

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UniCel DxI Operator's Guide 5.3: Running a Calibration

Changing the

Reagent Lot for a

Calibration

When you enter a calibration request, the system assigns the oldest reagent pack on board that is not empty, expired, or included in another calibration request. Use this procedure to change the assigned reagent lot.

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.

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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 in the Reference Manual .

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.

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The Most

Recent

Calibration

Data

Although all calibration data is stored on the system until you delete it, you can only view the most recent calibrations on the Calibration Data screen. For calibrations that 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 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

Previous

Active

Last Run

*

The data for the most recent calibration that passed.

*

Only active calibrations are used to evaluate patient samples.

The data for the calibration that was previously the active calibration. You can switch the previous active calibration with the active calibration.

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

Data Screen

Use the Calibration Data screen to:

• 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.

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Test

Reagent Lot

Calibrated

(for curves only)

Established

(for cutoffs only)

Expiration

Cutoff

(for cutoffs only)

2130A.bmp

(Field) Displays the test name of the calibrated assay.

(Field) Displays the lot number of the reagent used to calibrate the assay.

(Field) Displays the date and time the calibration was completed.

(Field not shown) Displays the date and time the calibration was completed.

(Field) Displays the date and time the calibration expires, as defined in the assay protocol file.

(Field not shown) Displays the cutoff value in RLUs established by this calibration for evaluating test results.

Figure 5-12 Calibration Data Screen Descriptions

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Units

Curve

Status

Reason

Cal Lot

5.4: Reviewing Calibration Data

(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.

(Field) Displays which of the recent calibrations is displayed on the screen. For

more information, see The Most Recent Calibration Data topic.

(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.

(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.

(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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5.4: Reviewing Calibration Data UniCel DxI Operator's Guide

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.

Curve (Log) or

Curve (Linear)

(for curves only)

Arrow Buttons

(for curves only)

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.

(Chart) Displays the curve generated from the calculated RLU means for this calibration.

• 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).

(Buttons) Select to move the point cursor on the curve to the next data point in the direction of the arrow. The next data point is selected in the data table.

Figure 5-12 Calibration Data Screen Descriptions (continued)

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UniCel DxI Operator's Guide 5.4: Reviewing Calibration Data

Acceptance Limits

(RLUs)

(for cutoffs only)

Select Curve

F1 or

Select Limits

F1

Switch Active

Curve

F2

(for curves only)

Comment

F3

Print

F7

(Table) Displays the upper and lower RLU measurement limits defined in the APF for each calibrator level of this assay. RLU readings beyond these limits result in 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.

(Button) Select to display a menu of the most recent calibrations for this reagent lot.

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, see The Most Recent Calibration Data topic.

(Button) Select to switch the active calibration for the assay with the previous

active calibration. For more information, see the Switching the Active with the

Previous Active Calibration procedure.

(Button) Select to display the Calibration Comment window, where you can enter,

view, or edit a comment about the calibration. For more information, see the

Entering, Viewing, or Editing a Calibration Comment procedure.

(Button) Select to print the Calibration Data Report for the displayed calibration.

For more information, see the Printing a Calibration Data Report procedure.

Figure 5-12 Calibration Data Screen Descriptions (continued)

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5.4: Reviewing Calibration Data UniCel DxI Operator's Guide

Viewing

Calibration

Data

Use this procedure to view detailed calibration data, along with the generated calibration curve or cutoff.

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.

System Mode: Any Mode

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

Active with the Previous

Active

Calibration

For quantitative and semi-quantitative assays only, use this procedure to switch the active calibration with the previous active calibration. For more information on active

and previous active calibrations, see The Most Recent Calibration Data topic.

NOTE

This procedure will not change calibration expiration dates or recalculate results for patient samples that have already been run.

System Mode:

1.

Ready Not Ready

From the Calibration screen, select the Assay button for the assay calibration you intend to switch.

2.

Select Review Data F2 to display the Calibration Data screen.

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,

Viewing, or

Editing a

Calibration

Comment

Use this procedure to enter, view, or edit a calibration comment. Comments print on the Calibration Data Report.

System Mode: Any Mode

1.

From the Calibration screen, select the Assay button for the assay calibration you intend to comment on.

2.

Select Review Data F2 to display the Calibration Data screen.

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

Calibration

Data Report

Use this procedure to print the information from the Calibration Data screen manually. You can also set the Calibration Data Report to print automatically after a calibration is run. For more information about report setup, see Section 2.2: System

Setup in the Reference Manual .

System Mode: Any Mode

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.

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5.4: Reviewing Calibration Data UniCel DxI Operator's Guide

Mean

Mean

Mean

Mean

Mean

Test Name:

Reagent Lot:

Calibrated:

Expiration:

Comment:

Stated Conc.

Mean

Calibration Data Report tUniCel DxI 800, Access Immunoassay System

S/N 610240

Laboratories, Inc.

Laboratory A

123 Lake Street

Townsville, ST 33333

101-555-2323 ext. 109 Jane Smith

Ferritin

000125

03/03/10 11:05 AM

03/31/10 11:05 AM

Calibration: Active

Status: Passed

Reason:

Cal Lot: 1 25002 ng/mL

S0 0.0

S0 0.0

RLU

11238

10730

10984.0

1SD %CV

359.2 3.3

S1 10.0

129201

S1 10.0 127697

S2 50.0

S2 50.0

128449.0

586338

597980

592159.0

1063.5

0.8

8232.1 1.4

S3 200.0

2202860

S3 200.0 2239570

S4 500.0

S4 500.0

2221215.0

4795090

4869380

4832235.0

S5 1500.0

S5 1500.0

9894830

9660040

9777435.0

25957.9 1.2

52531.0 1.1

166021.6 1.7

Calculated Conc. ng/mL Flags

0.0

No Value

0.0

10.3

10.2

10.3

49.3

50.3

49.8

197.6

201.2

199.4

495.6

505.6

500.6

1535.7

1464.2

1500.0

5-34

Technologist ______________________________________________

Page 1 of 1

Printed 03/03/10 11:05 AM

2132B.bmp

Figure 5-13 Calibration Data Report (Curve) Example

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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 .

2.

3.

4.

Troubleshoot test result flags. For more information, see Section 4.3: Reviewing

Test Results.

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 .

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.

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5.5: Troubleshooting Failed Calibrations UniCel DxI Operator's Guide

Calibration

Failure Codes

When a calibration fails, the system displays a failure code in the Reason field on the

Calibration Data screen and the Calibration Data Report.

Failure Code

Bad Fit

CV Std 0

Insuff Data

Limits

Max Iterate

No Fit

Resp Delta

Temp. Out

Description

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.

The %CV of the S0 (zero) calibrator replicates does not meet the acceptance criteria defined by the APF.

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.

The RLUs of either a replicate or the mean of the replicates are outside the accepted ranges defined in the APF.

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.

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.

The total response of the curve, which is the difference between the highest RLU reading and the lowest RLU reading, is too small.

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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UniCel DxI Operator's Guide 5.5: Troubleshooting Failed Calibrations

Assay

Calibration

Problems

When a calibration fails, look for and troubleshoot system errors. For more

information, see the introduction to this section (see Section 5.5: Troubleshooting

Failed Calibrations).

After ruling out or resolving system errors, use the following table to help troubleshoot remaining calibration problems.

Symptoms

Although precision is good, the calibration fails for any reason other than Insuff Data

Possible Causes Corrective Action

Multi-level calibrators aliquoted out of order, resulting in:

• A calibration curve that does not ascend or descend smoothly

• A calibration cutoff that is opposite of the expected result

Expired calibrator lot (CLX result flag)

1. Place the calibrators in the rack in the order

displayed on the Test Requests screen (see

Section 5.3).

2. Repeat the calibration.

Calibrator set beyond its stability date

Calibrator unstable or contaminated due to improper storage or handling

Reagent pack unstable or contaminated due to improper storage or handling

Incorrect calibration information entered during calibrator setup

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.

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.

Repeat the calibration. If possible, repeat with a new set of the same calibrator lot.

1. Unload the reagent pack and load a new reagent

pack (see Section 2.7).

2. Repeat the calibration.

1. Confirm the calibrator information on the

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.

2. Repeat the calibration.

Table 5-15 Failed Assay Calibration Troubleshooting Table

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5.5: Troubleshooting Failed Calibrations UniCel DxI Operator's Guide

Symptoms

Although precision is good, the calibration fails for any reason other than Insuff Data

(continued)

Possible Causes

A rack of patient samples was processed as a rack of calibrators because the racks had the same rack ID (when processing

LIS requests with host query)

Contaminated substrate supply

Corrective Action

1. Unload the racks (see Section 3.4) and look for

duplicate rack IDs.

2. If a patient sample rack has the same rack ID as the calibration request, process the patient samples

again (see Section 3.2), making sure that:

• 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.

Contact Technical Support. Decontaminate the substrate (see Section 6.4 in the Reference Manual ) only if instructed to do so by Technical Support.

1. Place the correct calibrators in the rack.

2. Repeat the calibration.

Although precision is good, the quantitative curve is flat or the qualitative result is

No Value; calibration fails for any reason other than Insuff Data

Wrong calibrator placed in rack

Routine maintenance not performed

Poor precision, and calibration fails for any reason other than Insuff

Data

Problems with the pipettor, substrate, or

RV wash system

1. Perform routine maintenance (see Section 7.1).

2. Repeat the calibration.

1. If the results of all System Check routines are within the expected ranges, these systems are not the cause of the calibration failure.

2. If the results of any of the System Check routines are not within the expected range, contact

Technical Support for assistance in troubleshooting.

1. Unload the reagent pack and load a new reagent

pack (see Section 2.7).

2. Repeat the calibration.

RLUs are too low at one end of the calibration curve, and calibration fails for any reason other than Insuff

Data

Reagent gone because it leaked out of the pack during off-board storage or a partial pack from another Access Immunoassay

System was loaded on the UniCel DxI system

Some reagent loss during off-board storage (first few test replicates between

6,000-9,000 RLU, remaining replicates acceptable)

Repeat the calibration with the open reagent pack.

Note:

During processing, the instrument attempted to aliquot the lost reagent from the reagent pack and aspirated air for the first few test replicates, resulting in low RLUs.

Once the pipettor reached the actual level of reagent in the pack, the RLUs returned to acceptable levels.

Table 5-15 Failed Assay Calibration Troubleshooting Table (continued)

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UniCel DxI Operator's Guide 5.5: Troubleshooting Failed Calibrations

Symptoms

Calibration fails for the reason

Insuff Data

Possible Causes

Quantity of calibrator not sufficient for testing (QNS result flag and event)

Two or more replicates not calculated due to instrument error

Calibrator sample missing from required position

Corrective Action

1. Calculate the correct volume of calibrator needed for the number of replicates and type of sample

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

Section 2.3 in the Reference Manual ).

4. Repeat the calibration.

5. If the calibration fails again for the same reason, contact Technical Support for assistance.

1. Review the Event Log messages (see Section 5.2 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, contact Technical Support for assistance.

4. After resolving the device errors, repeat the calibration.

1. Place the sample containers in the rack in the

order displayed on the Test Requests screen (see

Section 5.3).

2. Repeat the calibration.

Table 5-15 Failed Assay Calibration Troubleshooting Table (continued)

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5.5: Troubleshooting Failed Calibrations UniCel DxI Operator's Guide

5-40 © 2022 Beckman Coulter, Inc.

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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

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6-1

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

6-2 © 2022 Beckman Coulter, Inc.

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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.

You should run quality control samples as recommended in the reagent instructions for use and after any scheduled or unscheduled maintenance to verify assay calibration. After installing new software, run quality controls for all assays you use to report patient results, then recalibrate any assays with out-of-range quality control results. You may choose to run quality controls more frequently based on good laboratory practices or laboratory accreditation requirements and applicable laws.

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.

© 2022 Beckman Coulter, Inc.

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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 results?

No Troubleshoot failed QC and correct problem as indicated

Yes

Review QC charts and data or compare charts

Are all results in range?

No

Troubleshoot out-of-range

QC, correct problem, or adjust QC ranges, as indicated

Yes

Report patient sample results

Figure 6-1 Quality Control Flowchart

2048B.wmf

6-4 © 2022 Beckman Coulter, Inc.

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UniCel DxI Operator's Guide

Quality

Control

Screen

6.1: Quality Control Overview

Use the Quality Control screen to:

• 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 the QC Review Report

Filter

Entries

Comparison

Buttons

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2062B.bmp

(Field) Displays the current filter and sort parameters.

(Field) Displays the combined number of quality controls and comparisons that meet the current filter parameters.

(Buttons) Select a Comparison button to view a saved comparison.

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

6-5

6.1: Quality Control Overview UniCel DxI Operator's Guide

QC Buttons

Filter

F1

Review Chart and

Data

F2

Compare Charts

F3

(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.

(Button) Select to change the filter and sort order parameters for quality controls.

Comparison buttons are always displayed before QC buttons.

(Button) Select to view the accumulated data for the selected QC button. This button is not available if more than one QC button is selected, or if a Comparison button is selected.

(Button) Select to view the charts for two or three quality controls. This button is available only when two or three QC buttons are selected, or when a Comparison button is selected.

(Button) Select to delete one or more saved comparisons.

Delete Comparison

F4

QC Setup

F5

Print

F7

(Button) Select to display the QC Setup screen to add, edit, or delete quality controls.

(Button) Select to print a report of the quality controls that are currently set up. For

more information, see the Printing the QC Review Report topic.

Figure 6-2 Quality Control Screen Descriptions (continued)

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UniCel DxI Operator's Guide 6.1: Quality Control Overview

Applying a Quality

Control Filter

A quality control filter is a set of parameters you can change to reduce or expand the number of quality controls displayed on the Quality Control screen.

Use this procedure to apply a different filter or sort order to the Quality Control screen.

System Mode: Any Mode

1.

From the Quality Control screen, select Filter F1 to display the Filter window.

Filter

Instruments

Sort Order

Ascending

Description

(List) Select a filter to apply to the Quality Control screen.

0758A.bmp

(List) Displays the system ID of the instrument.

(Option) Select a first and second sort order.

(Box) Select to sort the quality controls in ascending order. Clear the box to sort the quality controls in descending order.

(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.

© 2022 Beckman Coulter, Inc.

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6-7

6.1: Quality Control Overview UniCel DxI Operator's Guide

 (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

Rules

Westgard QC rules are interpretive rules developed to avoid excessive false rejection 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:

• 1

2s

(1-2s) — The system marks a data point if it is more than 2 SD from the mean.

• 2

2s

(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.

• 1

3s

(1-3s) — The system marks a data point if it is more than 3 SD from the mean.

• 4

1s

(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.

• 10 x

(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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UniCel DxI Operator's Guide 6.1: Quality Control Overview

QC Status

Indicators and

Flags

In addition to being provided on screens that are specific to quality controls, QC status information is provided in a number of other places.

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.

QC Buttons

2010A.bmp

Figure 6-4 Quality Control System Status Button

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

QEX

Indicates that the QC test violated one or more Westgard QC rules

Indicates that the QC lot has expired

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6.1: Quality Control Overview UniCel DxI Operator's Guide

Printing the

QC Review

Report

Use this procedure to print the QC Review Report. This report lists all of the quality controls in the current filter of the Quality Control screen. To print the report, select

Print F7 .

System Mode: Any Mode

QC Review Report tUniCel DxI 800, Access Immunoassay System

S/N 610240

Laboratories, Inc.

Laboratory A

123 Lake Street

Townsville, ST 33333

101-555-2323 ext. 109 Jane Smith

Filter: All Controls - Sorted by Test Name and Control Name

Control Name Control Lot Test Name Expiration

CardiacA

CardiacB

CardiacC

CardiacA

CardiacB

CardiacC

HighControl

LowControl

CardiacA

CardiacB

CardiacC

HighControl

LowControl

1234567A

1234567B

1234567C

1234567A

1234567B

1234567C

98765C

98765A

1234567A

1234567B

1234567C

98765C

98765A

CK-MB

CK-MB

CK-MB

Dig

Dig

Dig freePSA freePSA

MYO

MYO

MYO

PSA-Hyb

PSA-Hyb

12/10/03

12/10/03

12/10/03

12/10/03

12/10/03

12/10/03

12/10/03

12/10/03

12/10/03

12/10/03

12/10/03

12/10/03

12/10/03

Instrument

654321

654321

654321

654321

654321

654321

654321

654321

654321

654321

654321

654321

654321

Designated

Pipettors

3,4

1,3

2

1,2,3,4

1

3

N/A

N/A

3

3,4

1,3

2

1,2,3,4

Technologist ____________________________________________

Figure 6-5 QC Review Report Example

Page 1 of 1

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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

QC Setup

Screen

UniCel DxI Operator's Guide

Use this screen to:

• View all of the quality controls that have been set up

• Add a quality control

• Edit an existing quality control

• Delete a quality control

Control

Control Lot

Expiration

Sample

Add Control

F1

Edit Control

F2

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(Column) Displays the name of the quality control.

(Column) Displays the number of the quality control lot.

(Column) Displays the expiration date of the quality control lot.

(Column) Displays the sample type.

(Button) Select to add a new quality control lot.

(Button) Select to edit the selected quality control.

Figure 6-6 QC Setup Screen Descriptions

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Delete Control

F6

(Button) Select to permanently remove the selected quality control and all 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

Editing a

Quality

Control Lot

Use this procedure to add a new quality control lot or to edit an existing quality control lot.

System Mode: Any Mode

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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Control

Lot Number

Expiration

Sample Type

Test Name

Mean

SD

Unit

2181B.bmp

(List or Field) Select a quality control to edit, or enter the name of a quality control to add.

(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.

(Field) Displays the expiration date for the quality control. If you are adding a quality control, enter the expiration date.

(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.

(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 .

(Field) Enter the expected mean for the test. If a test has been disabled, the Mean field cannot be changed.

(Field) Enter the expected standard deviation for the test. If a test has been disabled, the SD field cannot be changed.

(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

Rules

Designated

Pipettors

(Boxes) Select the rules to apply for the new control. If a test has been disabled, the

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.

(Field) Displays the reagent pipettors designated to process the test. Each designated pipettor runs one replicate of each requested test. If a test has been disabled, the designated pipettors fields cannot be changed.

(Button) Select to clear the information from a selected row.

Clear Row

F3

Designate Pipettor

F4

(Button) Select to designate one or more reagent pipettors to use for the selected

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 the Reference Manual .

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

Reagent

Pipettors for a

Quality

Control

Use this procedure to designate one or more reagent pipettors to be used for a QC test, or to allow the test to randomly use any assigned pipettor.

NOTES

• When you designate pipettors to use for a QC test, the test runs once on each 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

Setup in the Reference Manual .

To perform this procedure from the Add Control window, begin with step 4.

System Mode: Any Mode

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.

Currently

Assigned for

[assay]

2224B.bmp

(Fields) Displays a check mark under the number of each reagent pipettor that has been assigned to this assay. For more information, see Section 3.3: Test Setup in the Reference Manual .

Figure 6-8 QC Pipettor Window Descriptions

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Designate

Pipettors for this

Control

Any Assigned

Pipettor

(Option and Boxes) Select one or more assigned reagent pipettors to be used for the quality control. The quality control will be run with each designated pipettor.

Boxes are not available for pipettors that are not assigned to this assay.

(Option) Select to allow the system to use any assigned pipettor when the quality 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

Quality

Control

6.2: Setting Up Quality Controls

Use this procedure to delete a quality control and all the data points associated with that quality control lot.

NOTES

• Before deleting a quality control, you may want to print the data or copy it to a disk or flash drive.

• 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 .

System Mode:

1.

Ready Not Ready

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 .

4.

Enter the system password, then select OK F1 .

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

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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Entering QC

Test Requests

Use this procedure to enter a test request for a quality control sample or a multi-level 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.

2.

• 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.

System Mode: Any Mode

1.

From the Main Menu, select Sample Manager F1 to display the Sample Manager screen.

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.

3.

4.

Enter the rack ID in the Enter ID field and press [Enter] .

Select Request QC F5 .

The Request QC window is displayed.

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Control

Control Lot

(Column) Select the quality controls you want to run.

(Column) Displays the quality control lot numbers.

2047C.bmp

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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Reagent

Reagent Lot

2060C.bmp

(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.

(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

Test Buttons

(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.

(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

Patient/QC Requests F1

Test Requests

Enter the rack ID and press

[Enter]

Request QC F5

Request QC

Select quality controls

OK F1

Test Requests

Select tests for each quality control

Place the samples in the rack and load the rack

Figure 6-11 Entering QC Test Requests Flowchart

2057B.wmf

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Editing QC

Test Requests

Use this procedure to edit a QC test request that has been entered, but not yet run.

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.

System Mode: Any Mode

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.

Select the sample position that you want to edit.

4.

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

Reagent Lot for QC Test

Requests

Use this procedure to assign an on-board reagent lot to use for a particular QC sample.

System Mode: Any Mode

1.

From the Test Requests screen, select the sample position for which you want to 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

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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QC Chart and

Data Screen

Use the QC Chart and Data screen to:

• View QC data and charts

• Copy QC data to a disk or flash drive

• Print reports

Test

Control

Control Lot

Expiration

Instrument

Pipettor

2058B.bmp

(Field) Displays the name of the test.

(Field) Displays the name of the quality control.

(Field) Displays the lot number of the quality control.

(Field) Displays the expiration date of the quality control lot.

(Field) Displays the system ID of the instrument.

(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

Start

End

Mean

SD

%CV

Points

Point Cursor

Calibration Line

Y-axis Left Scale

(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.

(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.

(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.

(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 .

(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.

(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.

(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.

(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.

(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.

(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

X-axis

Points

Arrow Buttons

(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.

(Chart item) Displays the dates for the chart. Also see the Levey-Jennings Charts

topic.

(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.

(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

SDI

(Column) Displays the test result and the unit of measure.

(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

Omit

Pipettor

Filter

F1

(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.

(Box) Select to omit the result from QC calculations. The point remains on chart, but has a slash through it.

(Column) Displays the number of the reagent pipettor used for the QC test.

(Button) Select to limit displayed data to certain reagent lots, date ranges, and

reagent pipettors. For more information, see the Applying a QC Chart and Data

Filter topic.

Figure 6-12 QC Chart and Data Screen Descriptions (continued)

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Delete Point

F5

(Button) Select to delete the currently selected point and all data associated with

that point from the system. For more information, see the Deleting a QC Data

Point topic.

Copy to Disk

F6

Print

F7

NOTE

You need a password to use this feature.

(Button) Select to copy QC data. For more information, see the Copying QC

Data to a Disk or Flash Drive procedure.

(Button) Select to print the QC chart and data for the currently selected quality

control and date range. For more information, see the Printing a QC Chart or

Data Report topic.

Figure 6-12 QC Chart and Data Screen Descriptions (continued)

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Levey-

Jennings

Charts

6.4: Reviewing Quality Control Charts and Data

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

The X-axis of the chart is the time scale, and displays date ranges of up to 31 days.

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

Applying a QC

Chart and

Data Filter

Use a QC chart and data filter to control the amount of data displayed on the QC Chart and Data screen and printed in reports. The filter limits data according to the 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:

System Mode: Any Mode

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

Reagent Lot

View Specific

Pipettor

2225A.bmp

(Options) Select a date range. Options are:

• Last week (7 days)

• Last month (31 days)

• Specify (enter a start and end date)

(List) Select all reagent lots, or a single lot from the list

(Boxes) Select any combination of the reagent pipettors

Figure 6-14 Filter (QC Chart & Data) Window Descriptions

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

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

Charts and

Data

Use this procedure to view the QC data for a selected test.

System Mode: Any Mode

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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6.4: Reviewing Quality Control Charts and Data

Entering

Quality

Control

Comments

UniCel DxI Operator's Guide

Use this procedure to enter, edit, or delete comments for quality control test results on the QC Chart and Data screen.

System Mode: Any Mode

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.

4.

0728A.bmp

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

Omitting a QC

Data Point

Use this procedure to omit a point from the QC calculations for the mean, SD, and

%CV. Omitted points continue to display on the screen and are included in reports.

System Mode: Any Mode

1.

From the Quality Control screen, locate and select the quality control that contains the point you want to omit.

2.

3.

4.

Select Review Chart and Data F2 .

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.

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

Data Point

Use this procedure to permanently delete a selected point from the screen, reports, and

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 .

System Mode:

1.

Ready Not Ready

From the Quality Control screen, locate and select the quality control that contains the point you want to delete.

2.

3.

4.

5.

Select Review Chart and Data F2 .

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.

Select Delete Point F5 .

Enter the system password, then select OK F1 .

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

Printing a QC

Chart or Data

Report

Use this procedure to print a QC Chart Report, a QC Data Report, or both reports.

System Mode: Any Mode

1.

From the Quality Control screen, locate and select the quality control you want to print.

2.

Select Review Chart and Data F2 .

 (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.

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Report Type

2090A.bmp

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

Print Entire Date

Range

(Box) Select to print the entire date range selected in the

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

.

QC Data Report

UniCel DxI 800, Access Immunoassay System

S/N 654321

Test:

Control:

Control Lot:

Expiration:

Stated Mean:

Stated SD:

Des. Pipettor:

Value

2.90 ng/mL

2.99 ng/mL

8.17 ng/mL

SDI

0.5

0.9

26.8

PSA-Hyb

BRLevel2

1234567B

12/31/12

2.800

0.200

1,3,4

Completion

10/01/10 08:39 PM

10/02/10 08:35 PM

10/03/10 08:25 PM

2.71 ng/mL

2.83 ng/mL

2.66 ng/mL

2.82 ng/mL

2.23 ng/mL

2.67 ng/mL

2.90 ng/mL

-0.5

0.2

-0.7

0.1

-2.9

-0.7

0.5

10/03/10 09:10 PM

10/04/10 08:37 PM

10/05/10 08:52 PM

10/06/10 03:12 PM

10/07/10 04:18 PM

10/07/10 04:56 PM

10/07/10 05:02 PM

Laboratories, Inc.

Laboratory A

123 Lake Street

Townsville, ST 33333

101-555-2323 ext. 109

Jane Smith

Start Date:

End Date:

Points:

Mean:

SD:

%CV:

Units:

10/01/10

10/07/10

8

2.811

0.122

4.33

ng/mL

QC Rules

*1* *3*

*1*

Comment

Contaminated sample- retest with new sample

X

Omit Reagent Pipettor

Lot

130161 1

130161 4

130161 3

X

130161 3

130161 1

130161 4

144219 1

144219 3 Sample left in instrument too long- retest

144219 4

144219 3

QC Rules: 1=1-2s, 2=2s, 3=1-3s, 4=4-1s, X=10x

Technologist _____________________________________________

Figure 6-16 QC Data Report Example

Page 1 of 1

Printed 10/10/10 05:32 PM

2082B.bmp

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

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Figure 6-17 QC Chart Report Example

2083C.bmp

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

Copying QC

Data to a Disk or Flash Drive

Use this procedure to copy QC data to a 3.5-inch high density, DOS-formatted disk or a USB flash drive. The system copies the QC data into a comma-separated field 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

System Mode: Any Mode

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

Charts Screen

Use this screen to:

• Compare the Levey-Jennings charts for two or three quality controls

• Save a comparison of the charts

Chart Name

Date Range

Mean

2064B.bmp

(Field) Displays the test name, quality control name, quality control lot number, and system ID for data on the screen.

(Field) Displays the start and end dates for the chart data.

(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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6.5: QC Chart Comparisons UniCel DxI Operator's Guide

SD

%CV

Points

Levey-Jennings

Charts

Save

Comparison F1

Review Chart and Data F2

Edit Date

Range F4

(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..

(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..

(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.

(Chart) Displays a graph of the plotted points from each control. For more information

about charts, see the QC Chart and Data Screen and Levey-Jennings Charts topics in

Section 6.4: Reviewing Quality Control Charts and Data.

(Button) Select to save the comparison. The system creates a Comparison button which can be selected to view the comparison.

(Button) Select to display the QC Chart and Data screen for one of the charts. A menu of chart numbers is displayed. Charts are numbered sequentially from the top.

(Button) Select to change the range of dates for which QC data is displayed. For more

information, see the Changing the Date Range topic.

Figure 6-18 Compare Charts Screen Descriptions (continued)

Comparing

QC Charts

Use this procedure to view QC charts for two or three quality controls at the same time.

System Mode: Any Mode

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

Is correct date range displayed?

Yes

No

Edit Date Range F4

Edit Date Range

Change the date range

Save the comparison?

No

Yes

Save Comparison F1

Save Comparison

Enter text to name the comparison

Continue reviewing or processing data

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Figure 6-19 Comparing QC Charts Flowchart

2103B.wmf

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6.5: QC Chart Comparisons UniCel DxI Operator's Guide

Changing the

Date Range

Use this procedure to change the date range used for QC chart comparisons.

System Mode: Any Mode

1.

From the Compare Charts screen, select Edit Date Range F4 to display the Edit

Date Range window.

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Options

Start

End

2094A.bmp

(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

(Field) Enter the first date of the range you want to view.

(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

Comparisons

Use this procedure to save a comparison displayed in the Compare Charts screen.

System Mode: Any Mode

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

Comparisons

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

System Mode: Any Mode

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 .

A confirmation window is displayed.

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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

Data to

Establish QC

Ranges

Use this procedure over a 15-day period to gather sufficient data to establish quality control ranges for a specific UniCel DxI instrument.

Required Materials

• 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

Data and

Establishing

Ranges

Use this procedure to evaluate accumulated QC data and establish acceptable ranges of values for each level of a tri-level quality control set on a specific UniCel DxI instrument.

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

QC Problems

Use the following procedure to troubleshoot QC problems.

NOTE

For assays that have more than one reagent pipettor assigned, any troubleshooting step that produces acceptable QC results should be repeated on all pipettors that previously produced failed QC results.

1.

Identify event log errors. Contact Technical Support if you need help troubleshooting event log errors. 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.

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

Wrong quality control loaded onto the sample rack

Wrong quality control lot number selected for the test

Wrong mean and/or standard deviation information entered when setting up the quality controls

1. Prepare new quality control according to the procedure provided by the manufacturer.

2. Load the freshly prepared quality control and repeat the test.

1. Load the correct quality control.

2. Repeat the test.

Repeat the test using the correct lot number.

1. Review the QC information using Edit Control F2 from the QC Setup screen.

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.

9.

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 .

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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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

QC Test

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

System Mode: Any Mode

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

Section 4.2: Test Result Filters.

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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3.

Go to the Sample Manager screen and select New Request F3 , then select

Patient/QC Requests F1 to display the Test Requests screen.

4.

Enter the rack ID in the Enter ID field and press [Enter] .

5.

Select Request QC F5 .

The Request QC window is displayed.

6.

Select the quality control to rerun. The test is automatically removed from the work pending list, and is added to the test list for the quality control.

7.

Complete the test request by exiting the Test 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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7.5 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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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 at the Diagnostics menu

Device Diagnostics F4

Device Diagnostics

Begin the remaining 10,000 test interval maintenance procedures **

Close the right main upper cover

1 - Remove and inspect the dispense

probes

2 - Inspect pump connections at the

wash buffer reservoir

3 - Inspect the upper aspirate peristaltic

pump connections

4 - Inspect the reagent pipettors and

clean the wash towers

5 - Inspect for fallen RVs

Exit the Device Diagnostics screen and initialize the system

Open the right main upper cover

Complete the remaining

10,000 test interval maintenance procedures **

Install clean* aspirate probes **

(weekly if testing for HIV levels or at 10,000 test interval maintenance)

Replace the duck bill valve **

(5,000 test interval maintenance)

Perform daily maintenance **

Run QC and evaluate any out-of-range results to verify system performance **

* Clean the used aspirate probes after

you complete all other maintenance

procedures

** Record that the procedure is complete on the Maintenance Log

1 - If your system uses bulk liquid

waste containers, inspect the liquid

waste drawer

2 - Inspect the wash buffer supply

drawer

3 - Clean the air filter

1 - Back up the system

2 - Record the test count

3 - Shake down the solid waste

container

4 - Run a clean routine

2270G.wmf

Figure 7-1 Routine Maintenance Overview Flowchart

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UniCel DxI Operator's Guide 7.1: Maintenance Overview

Maintenance

Review

Screen

Use the Maintenance Review screen to:

• Check or print the temperatures of the nine thermal zones

• Display the System Checks screen

• Display the Carryover screen

• Decontaminate the substrate system

• Run, enable, or disable the Utility routine

Zone

Temperature ( °C)

Limits ( °C)

2170D.bmp

(Fields) Displays the current temperature reading in degrees Celsius for nine 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.

(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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7.1: Maintenance Overview UniCel DxI Operator's Guide

Pipettor

Matching F1

Low Volume Matching F2

Use this function only as directed by Technical Support.

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

Substrate F4

Run Utility

Routine F5

(Button) Select to decontaminate the substrate system and any components that 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 .

(Button) Select to run the Utility routine manually. Run this routine only if 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 or

Enable

Utility Routine F6

Print F7

(Button) Select to display the Pipettor Matching menu with the following options:

Reag. Pipettor Matching F1

Use this function only as directed by Technical Support.

(Button) Select to disable or enable the automatic Utility routine. If enabled, the

Utility routine runs when the instrument has been idle for four hours. The button name switches between Disable Utility Routine and Enable Utility Routine each

time you select it. For more information, see the Enabling and Disabling the Utility

Routine procedure.

(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 the Utility

Routine

Manually

Use this procedure to manually request the Utility routine. Request the Utility routine when instructed to do so by Technical Support, or when additional cleaning is required for troubleshooting. The Event Log prompts you to manually request a

Utility routine whenever processing is interrupted. The Utility routine takes approximately three minutes to complete.

System Mode:

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

Disabling the

Utility Routine

Enabling the Utility routine sets up the instrument to run the routine every four hours when it is not processing samples. The system records an event in the Event Log each time you enable or disable the Utility routine.

Use this procedure to enable or disable the Utility routine on the Maintenance Review screen.

System Mode: Any Mode

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

Temperature

Report

The Temperature report is a printout of the thermal zone temperatures displayed on the Maintenance Review screen. To print a copy of the report, select Print F7 on the

Maintenance Review screen.

System Mode: Any Mode

Requesting

Maintenance

Routines

You can request and load maintenance routines while the system is processing samples. Requested routines run after calibrator, QC, and patient sample processing is complete.

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Use this procedure to request maintenance routines.

WARNING

You will come in contact with potentially infectious materials during this procedure. Handle and dispose of biohazard materials according to proper laboratory procedures. Proper hand, eye, and facial protection is required.

System Mode: Any Mode

1.

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

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System

Check

Routines

Clean

Routines

Other

Routines

(Options) Select one of the System Check routines.

• Washed - Checks the performance of the wash system.

• 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 .

(Options) Select one of the cleaning routines. For more

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.

(Options) Select one of the three pipettor matching routines only 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

Requests

Screen

Use the Maintenance Requests screen to:

• View and verify the required position and contents of each sample container for the selected maintenance routine

• Enter or change the rack ID

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UniCel DxI Operator's Guide 7.1: Maintenance Overview

Rack Button and

Enter ID

Contents

Position

Rack ID F1

New Request F3

(Button with field) Displays the rack ID, and the required position, contents, and volume of each container in the rack.

Select the Rack button to enter or change the current rack ID. The Enter ID field is displayed.

(Column) Displays the name of the requested maintenance routine, and the required contents and volume of each sample container in the rack.

(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.

(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.

(Button) Select to exit this request and to make a new request. There are three different request types.

Patient/QC Requests F1

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.

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

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 B

12 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

Select the most recent event listed on the screen

Details F4

Record the instrument test count on the Maintenance

Log

Request Maintenance

With the Utility routine enabled, select a clean routine

OK F1

Maintenance Requests

Enter the rack ID and press

[Enter]

Clean Routine Options

Daily Clean System

Special Clean: Select if you have run the Vitamin B

12 assay in the last 24 hours

Shake down the solid waste container *

Sample Manager

New Request F3

Maintenance F3

Prepare and load a rack

The system begins the clean routine *

Positions

1 - Add 3 mL Contrad 70

2 - Add 3 mL 1:5 dilution of Citranox

3 (Special Clean only) - Add 4 mL 70%

Ethanol solution

Time to Completion

Daily Clean System: Approximately 10 minutes

Special Clean: Approximately 13 minutes

* Record that the procedure is complete on the Maintenance

Log

2105F.svg

Figure 7-5 Daily Maintenance Flowchart

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Backing Up the System

Use this procedure to back up the system each day to save your system data files.

System Mode:

1.

Ready Not Ready

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

Test Count

The 10,000 and 5,000 test interval maintenance procedures are scheduled after the

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.

System Mode: Any Mode

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

Down the

Solid Waste

Container

As the UniCel DxI system processes samples, waste accumulates in the solid waste container in a conical pattern. If the accumulated waste grows too high, it may 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 each day.

WARNING

You will come in contact with potentially infectious materials during this procedure. Handle and dispose of biohazard materials according to proper laboratory procedures. Proper hand, eye, and facial protection is required.

CAUTIONS

• 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.

System Mode: Any Mode

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.

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7.2: Daily Maintenance

Running

Clean

Routines

UniCel DxI Operator's Guide

Clean routines keep the sample, reagent, and aspirate probes clean and working properly. Run one of two clean routines each day as a part of daily maintenance.

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

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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.

• 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 the Reference Manual .

Procedure Steps

System Mode:

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 B

12

assay during the last 24-hour time period. Otherwise, run the Daily Clean System routine.

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7.2: Daily Maintenance UniCel DxI Operator's Guide

4.

Select OK F1 to display the Maintenance Requests screen.

The sample containers and contents for the selected routine are displayed on the screen.

5.

Enter the rack ID in the Enter ID field and press [Enter] .

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.

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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.

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7.3: Special Weekly Maintenance UniCel DxI Operator's Guide

Begin special weekly maintenance at the

Diagnostics menu

Device Diagnostics F4

Device Diagnostics

Exit the Device Diagnostics screen and initialize the system

Open the right main upper cover

Perform daily maintenance *

Install clean aspirate

probes *

Verify system performance *

* Record that the procedure is complete on the

Maintenance Log Close the right main upper cover

Figure 7-6 Special Weekly Maintenance Overview Flowchart

2301D.wmf

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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.

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Begin 5,000 test maintenance at the

Diagnostics menu

Device Diagnostics F4

Device Diagnostics

Exit the Device Diagnostics screen and initialize the system

Perform daily maintenance * Open the right main upper cover

Replace the duck bill valve *

Verify system performance *

Close the right main upper cover

* Record that the procedure is complete on the

Maintenance Log

2300D.wmf

Figure 7-7 Test Interval Maintenance (5,000 Tests) Overview Flowchart

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

Replacing the

Duck Bill

Valve

Use this procedure to replace the duck bill valve. Replace the duck bill valve 5,000 tests after the valve was last replaced, or as instructed by the system documentation or by a technical support representative.

WARNINGS

• Never wear exposed metal that can come into contact with electrical components of the instrument.

• You will come in contact with potentially infectious materials during this procedure. Handle and dispose of biohazard materials according to proper laboratory procedures. Proper hand, eye, and facial protection is required.

CAUTIONS

• 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.

System Mode: Ready Not Ready

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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7.4: Test Interval Maintenance: 5,000 Tests

7

7-24

UniCel DxI Operator's Guide

6

5

4

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)

6 A2 aspirate probe on the A2 aspirate probe support arm

7 A3 aspirate probe on the A3 aspirate probe support arm

2187C.eps

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

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

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7-26

A1

D2

1 A1 aspirate probe fitting

3 A1 aspirate probe

5 Plastic shoulder of the wash collar

7 Duck bill valve

9 Key slot

2

4

6

8

10

D2 dispense probe fitting

Wash collar

Retaining nut

Dispense probe plate

Aspirate probe plate

Figure 7-9 Wash Collar and Duck Bill Valve

2241C.eps

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

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.

4.

5.

6.

7.

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).

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.

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.

Turn the collar counterclockwise to secure the plastic shoulder on the dispense probe plate.

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.

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UniCel DxI Operator's Guide

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.

9.

• If the probe does not snap back after verifying the wash collar position and replacing the probe, contact Technical Support for assistance.

Record that the procedure is complete on the Maintenance Log. For more

information, see Section 7.6: Maintenance Log.

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:

Instrument Cover Procedures in the Reference Manual .

e. Exit the Device Diagnostics screen. f.

Initialize the system. For more information, see Section 4.2: Initialize System in the Reference Manual .

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.

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

For 5,000 test maintenance, begin this procedure at the Diagnostics menu

If continuing from 10,000 test maintenance, begin the procedure here

Device Diagnostics F4

Turn the wash collar clockwise and pull the collar down through the key slot

Device Diagnostics

Push the wash collar up through the key slot and turn the collar counterclockwise to secure

Turn the retaining nut counterclockwise and remove from the wash collar

Return the A1 aspirate probe to its proper place

Open the right main upper cover

Lift the duck bill valve out of the retaining nut and discard the valve in the biohazard waste

Tighten the probe fitting and verify the aspirate probe deflection

Gently lift the dispense probe plate and slide a sample rack beneath the plate

Insert a new valve into the retaining nut

Record that the procedure is complete on the

Maintenance Log

Remove the sample rack from beneath the dispense probe plate

Close the right main upper cover

Exit the Device Diagnostics screen and initialize the system

Perform daily maintenance and verify system performance

Loosen the A1 aspirate probe fitting and remove the probe

Attach the retaining nut to the wash collar by turning it clockwise

Continue with

10,000 test maintenance?

No

Yes

Inspect the duck bill valve

Remove and inspect the dispense probes

No Is the valve closed?

Yes

For more information, see Figure 7-15

Confirm that the dispense probe tubing is routed correctly

2240K.wmf

Figure 7-11 Test Interval Maintenance (5,000 Tests): Replacing the Duck Bill Valve Flowchart

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Verifying

System

Performance

Verify system performance after completing maintenance on the duck bill valve or the aspirate and dispense probes, and before you process any samples. If you are performing other maintenance procedures, verify performance after you finish all scheduled maintenance.

Use this procedure to verify system performance.

System Mode:

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.

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UniCel DxI Operator's Guide 7.5: Test Interval Maintenance: 10,000 Tests

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.

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Begin 10,000 test maintenance at the Diagnostics menu

Device Diagnostics F4

Device Diagnostics

Is 5,000 test maintenance scheduled?

No

Yes

Replace the duck bill valve *

Inspect the reagent pipettors and clean the wash towers *

Inspect the wash buffer supply drawer *

Open the right main upper cover

Install clean aspirate probes *

(unless your lab installs clean probes weekly for HIV testing)

Remove and inspect the dispense probes *

Open the left main upper cover

Inspect for fallen RVs *

Close the left and right main upper covers

Clean the air filter *

Perform daily maintenance *

Inspect the pump connections at the wash buffer reservoir *

Inspect the upper aspirate peristaltic pump connections *

Exit the Device Diagnostics screen and initialize the system

If your system uses bulk liquid waste containers, inspect the liquid waste drawer*

Verify system performance *

* Record that the procedure

is complete on the

Maintenance Log

2260G.svg

Figure 7-12 Test Interval Maintenance (10,000 Tests) Overview Flowchart

Installing

Clean

Aspirate

Probes

As the system processes samples, paramagnetic particles can accumulate inside the aspirate probe or on the probe exterior. A dirty aspirate probe can affect system performance.

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.

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UniCel DxI Operator's Guide 7.5: Test Interval Maintenance: 10,000 Tests

Required Materials

• An empty sample rack

• Several clean, lint-free tissues

• Three clean aspirate probes

Removing the Aspirate Probes

WARNINGS

• Never wear exposed metal that can come into contact with electrical components of the instrument.

• You will come in contact with potentially infectious materials during this procedure. Handle and dispose of biohazard materials according to proper laboratory procedures. Proper hand, eye, and facial protection is required.

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.

System Mode:

1.

Ready Not Ready

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 .

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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.

6.

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).

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).

1

7-34

2264B.eps

1 Probe fitting

Figure 7-13 Loosening a Probe Fitting

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UniCel DxI Operator's Guide 7.5: Test Interval Maintenance: 10,000 Tests

8.

9.

Lift the aspirate probe out of the aspirate probe plate and set the probe down on several clean, lint-free tissues.

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.

3

A3 D3 A2

A3

D3

A2

D2

D1

A1

A1W

D2 D1 A1 A1W

1

2

D2 D1 A1 A1W

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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)

2353A.eps

Figure 7-14 Aspirate and Dispense Probe Manifold

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7.5: Test Interval Maintenance: 10,000 Tests

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UniCel DxI Operator's Guide

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

You will come in contact with potentially infectious materials during this procedure. Handle and dispose of biohazard materials according to proper laboratory procedures. Proper hand, eye, and facial protection is required.

CAUTIONS

• 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.

• 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.

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UniCel DxI Operator's Guide 7.5: Test Interval Maintenance: 10,000 Tests

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.

2.

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).

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

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7.5: Test Interval Maintenance: 10,000 Tests UniCel DxI Operator's Guide 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.

3

2

1

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.

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UniCel DxI Operator's Guide 7.5: Test Interval Maintenance: 10,000 Tests

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).

1

2

3

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

2315A.eps

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.

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10.

Record that the procedure is complete on the Maintenance Log. For more

information, see Section 7.6: Maintenance Log.

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 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:

Instrument Cover Procedures in the Reference Manual .

e. Exit the Device Diagnostics screen.

f.

Initialize the system. For more information, see Section 4.2: Initialize System in the Reference Manual .

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.

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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

Device Diagnostics

Gently lift the dispense probe plate and slide a sample rack beneath the plate

Disconnect the tubing fitting from the manifold

Open the right main upper cover

Turn the probe fitting counterclockwise to loosen the aspirate probe

Lift the aspirate probe out of the aspirate probe plate and set the probe on lint-free tissues

Connect the tubing fitting of a clean probe to the manifold *

* Clean the removed aspirate probes after you complete all other maintenance procedures

Correctly route the probe tubing and place the clean aspirate probe in its proper position in the probe plate

Tighten the probe fitting and verify the aspirate probe deflection

Yes

Are there more aspirate probes to remove and install?

No

Record that the procedure is complete on the

Maintenance Log

Replace the duck bill valve and record that the procedure is complete on the

Maintenance Log

Perform daily maintenance and verify system performance

Yes

Are you only installing clean aspirate probes?

No

Yes

Are you performing special weekly maintenance?

No

Is 5,000 test maintenance scheduled?

No

Continue with

10,000 test maintenance?

Yes Remove and inspect the dispense probes

Yes

No

Exit the Device Diagnostics screen and initialize the system

For more information, see

Figure 7-15

Confirm that the dispense probe tubing is routed correctly

Remove the sample rack from beneath the dispense probe plate

Close the right main upper cover

2266K.wmf

Figure 7-17 Test Interval Maintenance (10,000 Tests): Installing Clean Aspirate Probes Flowchart

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Cleaning the

Aspirate

Probes

Use this procedure to clean the aspirate probes. Clean the aspirate probes you removed from the instrument at your earliest opportunity. Store the clean probes in 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

• 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.

• 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.

2.

Fill a small beaker with approximately 20 mL of Contrad 70 cleaning solution.

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.

4.

5.

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.

Remove the brush.

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.

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Washing the Aspirate Probe Interior

1.

2.

Fill a small beaker with approximately 50 mL of deionized water.

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).

1

2

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.

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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.

2.

Gently wipe down the exterior of the detached aspirate probe with an alcohol wipe.

Store the clean aspirate probe in your CARE kit.

Brush out the inside of the aspirate probe with

Contrad 70

Place the aspirate probe fitting in deionized water

Attach the syringe fitting assembly to the aspirate probe tip

Draw deionized water through the tubing fitting and into the syringe

Disconnect the syringe from the fitting assembly and discard the water in the sink

Reattach the syringe to the fitting assembly and draw and discard water two more times

Remove aspirate probe fitting from deionized water

Reattach the syringe to the fitting assembly and draw air through the tubing fitting and into the syringe

Disconnect the syringe and fitting assembly from the probe tip

Position the probe upright on absorbent paper for 10 minutes

Wipe down the aspirate probe exterior with an alcohol wipe

Store the clean aspirate probes in your CARE kit

Figure 7-19 Cleaning an Aspirate Probe Flowchart

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Removing and

Inspecting the

Dispense

Probes

Use this procedure to remove and inspect all three dispense probes 10,000 tests after the probes were last inspected.

As the system processes samples, crystalline deposits can accumulate on the dispense probe exterior and affect system performance.

WARNINGS

• Never wear exposed metal that can come into contact with electrical components of the instrument.

• You will come in contact with potentially infectious materials during this procedure. Handle and dispose of biohazard materials according to proper laboratory procedures. Proper hand, eye, and facial protection is required.

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.

• 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.

System Mode:

1.

Ready Not Ready

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 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.

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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.

7.

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.

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.

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13.

Record that the procedure is complete on the Maintenance Log. For more

information, see Section 7.6: Maintenance Log.

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 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.

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:

Instrument Cover Procedures in the Reference Manual .

b. Exit the Device Diagnostics screen.

c. Initialize the system. For more information, see Section 4.2: Initialize System in the Reference Manual .

d. Verify system performance. For more information, see the Verifying System

Performance procedure in Section 7.4: Test Interval Maintenance: 5,000

Tests.

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Begin this procedure at the Diagnostics menu

Device Diagnostics F4

Device Diagnostics

Lift the dispense probe out of the dispense probe plate and inspect the probe

Open the right main upper cover

Locate the dispense probes and inspect the tubing connections and fittings

Is the probe free of crystalline deposits?

Yes

No

Moisten a lint-free tissue with deionized water and wipe down the probe exterior

Correctly route the dispense probe tubing

For more information, see Figure 7-15

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

No

Are all probes inspected?

Remove the sample rack from beneath the dispense probe plate

Yes

Record that the procedure is complete on the

Maintenance Log

Continue with

10,000 test maintenance?

No

Yes

Close the right main upper cover

Exit the Device Diagnostics screen and Initialize the system

Confirm that the dispense probe tubing is routed correctly

Inspect pump connections at the wash buffer reservoir

Verify system performance

2268J.svg

Figure 7-20 Test Interval Maintenance (10,000 Tests): Removing and Inspecting the Dispense

Probes Flowchart

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Inspecting the

Pump

Connections at the Wash

Buffer

Reservoir

Use this procedure to visually inspect the pump connections at the wash buffer reservoir. The wash buffer reservoir is located beneath the left main upper cover.

WARNINGS

• Never wear exposed metal that can come into contact with electrical components of the instrument.

• You will come in contact with potentially infectious materials during this procedure. Handle and dispose of biohazard materials according to proper laboratory procedures. Proper hand, eye, and facial protection is required.

System Mode:

1.

Open the left main upper cover. For more information, see Section 6.2:

Instrument Cover Procedures in the Reference Manual .

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

1

2

3

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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

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7.5: Test Interval Maintenance: 10,000 Tests

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UniCel DxI Operator's Guide

3

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.

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Inspecting the

Upper

Aspirate

Peristaltic

Pump

Connections

Use this procedure to visually inspect the upper aspirate peristaltic pump connections and tubing. The upper aspirate peristaltic pump is located beneath the right main upper cover and to the right of the wash buffer reservoir.

WARNINGS

• Never wear exposed metal that can come into contact with electrical components of the instrument.

• You will come in contact with potentially infectious materials during this procedure. Handle and dispose of biohazard materials according to proper laboratory procedures. Proper hand, eye, and facial protection is required.

System Mode:

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.

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1

2

1

3

3

2

2261B.eps

3009A.eps

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.

4.

If you are performing 10,000 test interval maintenance, record that the inspection

is complete on the Maintenance Log. Perform the Inspecting the Reagent

Pipettors and Cleaning the Wash Towers procedure next.

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Inspecting the

Reagent

Pipettors and

Cleaning the

Wash Towers

Use this procedure to inspect and clean the reagent pipettors and the wash towers. The pipettors and towers are located beneath the left upper main cover. It is not necessary to inspect or clean the sample pipettor.

WARNINGS

• Never wear exposed metal that can come into contact with electrical components of the instrument.

• You will come in contact with potentially infectious materials during this procedure. Handle and dispose of biohazard materials according to proper laboratory procedures. Proper hand, eye, and facial protection is required.

System Mode:

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.

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UniCel DxI Operator's Guide

2

7-54

5 4 3

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

2330B.eps

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7.5: Test Interval Maintenance: 10,000 Tests

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, contact Technical Support for assistance.

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.

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1

UniCel DxI Operator's Guide

2262B.eps

1 Wash tower overflow reservoir

Figure 7-26 Inspecting the Wash Tower Reservoirs

9.

If you are performing 10,000 test interval maintenance, record that the inspection

is complete on the Maintenance Log. Perform the Inspecting for Fallen RVs

procedure next.

Inspecting for

Fallen RVs

Use this procedure to visually inspect for RVs that have fallen and are loose inside of the instrument.

WARNINGS

• Never wear exposed metal that can come into contact with electrical components of the instrument.

• You will come in contact with potentially infectious materials during this procedure. Handle and dispose of biohazard materials according to proper laboratory procedures. Proper hand, eye, and facial protection is required.

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System Mode:

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.

6.

7.

3.

4.

5.

8.

If you find any fallen RVs, carefully remove them from the instrument and dispose of them with your biohazard waste.

If you cannot remove an RV that is contributing to a system problem, contact

Technical Support for assistance.

Close both main upper covers. For more information, see Section 6.2: Instrument

Cover Procedures in the Reference Manual .

Exit the Device Diagnostics screen.

Initialize the system. For more information, see Section 4.2: Initialize System in the Reference Manual .

If you are performing 10,000 test interval maintenance, record that the inspection 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.

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Inspecting the

Liquid Waste

Drawer

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

WARNING

You will come in contact with potentially infectious materials during this procedure. Handle and dispose of biohazard materials according to proper laboratory procedures. Proper hand, eye, and facial protection is required.

System Mode: Any Mode

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.

7.

If you are performing 10,000 test interval maintenance, record that the inspection

is complete on the Maintenance Log. Perform the Inspecting the Wash Buffer

Supply Drawer procedure next.

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Inspecting the

Wash Buffer

Supply

Drawer

Use this procedure to visually inspect the wash buffer supply drawer. The wash buffer supply drawer is located on the lower right as you face the instrument.

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.

System Mode: Any Mode

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.

10.

If you are performing 10,000 test interval maintenance, record that the inspection

is complete on the Maintenance Log. Perform the Cleaning the Air Filter

procedure next.

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Cleaning the

Air Filter

Use this procedure to clean the air filter. The air filter is located behind the lower right 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

System Mode:

1.

Ready Not Ready

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.

7-60 © 2022 Beckman Coulter, Inc.

C95317-AA

UniCel DxI Operator's Guide 7.5: Test Interval Maintenance: 10,000 Tests

1

2

3

4

5

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

2243A.eps

© 2022 Beckman Coulter, Inc.

C95317-AA

7-61

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.

7-62 © 2022 Beckman Coulter, Inc.

C95317-AA

UniCel DxI Operator's Guide 7: Routine Maintenance

© 2022 Beckman Coulter, Inc.

C95317-AA

7-63

7.6: Maintenance Log UniCel DxI Operator's Guide

7-64 © 2022 Beckman Coulter, Inc.

C95317-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

© 2022 Beckman Coulter, Inc.

C95317-AA

A-1

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

A-2

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 Reference Manual .

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 .

© 2022 Beckman Coulter, Inc.

C95317-AA

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

Rack Sizes and

Containers

The following table lists the different sizes of racks, and the accepted container types

for each rack size. For more information about sample containers, see

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

13x75 mm

13x100 mm

16x75 mm

16x100 mm

*

Accepted Sample Containers

• 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 tube

• 0.5 mL cup

• 2 mL cup

• 1 mL insert cup in a 13x100 mm tube

• Pediatric insert cup in a pediatric tube adapter

• Autoaliquot tube

• 16x75 mm tube

• 75x15 mm 5.5 mL Sarstedt S-Monovette * tube

• 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

• 2 mL insert cup in a 16x100 mm tube

Table A-1 Rack Sizes and Container Types

Monovette is a trademark of Sarstedt AG & Co.

Cleaning

Sample Racks

You can clean your sample racks in a dishwasher or an autoclave. You can also wash the racks by hand using a brush and a mild detergent.

© 2022 Beckman Coulter, Inc.

C95317-AA

A-3

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

Remove caps from all sample containers before loading on the UniCel DxI system.

A-4 © 2022 Beckman Coulter, Inc.

C95317-AA

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

Calculating

Minimum

Sample

Volume

The sample volume in a container must be sufficient to process the requested tests, and can be increased to accommodate reflex tests or patient and QC reruns. For more information about setting the reserve volume, see Section 3.7: Reflex Test Setup in the Reference Manual .

Use this equation whenever you need to calculate the minimum sample volume for a container in a rack.

A

Sample assay volume

A

B

C

D

E

+

B

System dead volume

+

C

Reserve volume

(if set up)

+

D

Sample pipettor overdraw

+

E

Sample container dead volume

=

Minimum sample volume required

2223B.wmf

The sample assay volume is the sum of the sample volumes for each requested test. To find the sample volume for each test, see the corresponding reagent instructions for use.

The system dead volume is the amount of sample that cannot be drawn from an RV inside of the instrument. The system dead volume is 60 μ L for each RV.

(If set up) The reserve volume is the amount of sample the system stores for additional testing. For 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 μ L or 5% of the volume of sample in the RV (A + B + C), whichever is greater.

The sample container dead volume is the amount of sample that cannot be aliquoted from the sample

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 μ L, 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.

© 2022 Beckman Coulter, Inc.

C95317-AA

A-5

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

Example

Sample volume aliquot in one RV - The PSA assay has a sample volume of

25 μ L, and the fPSA assay has a sample volume of 25 μ L. The system is set up to draw 200 μ L 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.

B

C

A

D

E

Total sample volume for the requested tests

(25 μ L + 25 μ L)

System dead volume for one RV

50 μ L

Reserve volume

60 μ L

200 μ L

20 μ L Overdraw of 20 μ L or 5% of the volume in the RV, whichever is larger

One RV: 5% of (50 μ L + 60 μ L + 200 μ L) = 16 μ L, so use an overdraw of 20 μ L

Dead volume for a 2 mL cup (see Table A-2)

Minimum sample volume required for one RV

150 μ L

480 μ L

Example

Sample volume aliquot in two RVs The PSA assay has a sample volume of

25 μ L, and the fPSA assay has a sample volume of 25 μ L. The system is set up to draw 500 μ L of reserve volume. Here is how to calculate the minimum sample volume required for these two assays if you are using a 2 mL cup.

.

A

B

C

D

E

Total sample volume for the requested tests

(25 μ L + 25 μ L)

System dead volume for two RVs

(60 μ L + 60 μ L)

Reserve volume

50

120

μ L

μ L

Overdraw of 20 μ L or 5% of the volume for each RV, whichever is larger

First RV: 5% of (50 μ L + 60 μ L) = 6 μ L, so use an overdraw of 20 μ L

Second RV: 5% of (60 μ L + 500 μ L) = 28 μ L

Dead volume for a 2 mL cup (see Table A-2)

Minimum sample volume required for two RVs

500 μ L

48 μ L

150 μ L

868 μ L

A-6 © 2022 Beckman Coulter, Inc.

C95317-AA

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

Sample

Containers

The following table lists the sample containers that are accepted on the UniCel DxI instrument, along with their dead volume requirements.

WARNING

Racks are configured to accept only one type of sample container. 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

Remove caps from all sample containers before loading on the UniCel DxI system.

Container Type

Label

Sample Container Information

11.5x66 mm 3.5 mL S.60.549

Sarstedt tube

• Dead volume: 200 μ L

Container Type

Label

Sample Container Information

12 or 13x75 mm glass tube

• Dead volume: 500 μ L

12/13 x75

12 or 13x75 mm plastic tube

• Dead volume: 200 μ L

13x100 mm tube

• Dead volume: 500 μ L

12/13 x75 13x100

15.3x92 mm 5 mL S.62.611

Sarstedt tube

• Dead volume: 300 μ L

16x75 mm tube

• Dead volume: 800 μ L

Table A-2 Sample Containers and Their Dead Volume Requirements

16x75

© 2022 Beckman Coulter, Inc.

C95317-AA

A-7

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

Sample Container Information

16x85 mm tube

• Dead volume: 200 μ L

(This information only applies to the 16x85 mm

SBCL 10 mL screw-cap tube)

Container Type

Label

Sample Container Information

16x100 mm tube

• Dead volume: 800 μ L

16x85

75x15 mm 5.5 mL

Sarstedt S-Monovette tube

• Dead volume: 1100 μ L

92x15 mm 7.5 mL

Sarstedt S-Monovette tube

• Dead volume: 1200 μ L

Container Type

Label

16x100

1 mL insert cup in a 13x75 tube

• Dead volume: 350 μ L

0.5 mL cup

• Dead volume: 80 μ L

1 mL insert cup in a 13x100 mm tube

• Dead volume: 400 μ L

1 mL in

13x75

2 mL cup

• Dead volume: 150 μ L

1 mL in

13x100

2 mL

2 mL insert cup in a 16x100 mm tube

• Dead volume: 200 μ L

3 mL cup in a 16x100 mm rack

• Dead volume: 150 μ L

2 mL in

16x100 3 mL

Autoaliquot tube

• Dead volume: 150 μ L

Pediatric insert cup in a pediatric tube adapter

• Dead volume: 150 μ L

A-8

Aliquot PED

Table A-2 Sample Containers and Their Dead Volume Requirements (continued)

© 2022 Beckman Coulter, Inc.

C95317-AA

UniCel DxI Operator's Guide Index

Index

Symbols

10,000 test maintenance overview

7-3

procedures

7-31

5,000 test maintenance overview

7-3

procedures

7-21

A

Access Immunoassay Systems family

1-2

UniCel DxI

1-2

active calibrations

5-27

switching

5-32

AEX result flag

4-27

air bubbles prevent when pipetting

3-43

air filter cleaning

7-60

location

7-61

sharp edges

7-60

amber light monitoring supply status

2-4

status indicator

1-8, 2-4

APF

see

assay protocol file applications running other

1-15

aspirate and dispense probe manifold

7-35

aspirate probes

10,000 test maintenance

7-32

brushing interior

7-42

cleaning

7-42

cleaning (flowchart)

7-44

© 2022 Beckman Coulter, Inc.

C95317-AA electrical warning

7-33

handling with caution

7-33

HIV testing and maintenance

7-19

installing (flowchart)

7-41

installing clean

7-36

loosening fittings

7-34

positions

7-34

potentially infectious

7-33, 7-42

removing

7-33

replacing

7-32

syringe assembly

7-43

verifying deflection

7-28, 7-39

assay calibrations active

5-27

calibration data report

5-33

calibration report

5-8

calibration screen

5-5

calibration screen filter

5-6

calibrator setup

5-10

comments

5-33

curves

5-26

cutoffs

5-26

deleting

5-7

excluded replicates

5-32

expired 5-3 failed qualitative

5-38

failure codes

5-36

flowchart

5-4

last run

5-27

most recent data

5-27

overview

5-3

poor precision

5-38

previous active

5-27

problems with

5-37

reagent lot assignment

5-25

running a calibration

5-19

switching

5-32

Index-1

Index

Index-2 system prompts

5-3

test requests

5-22

troubleshooting

5-35

troubleshooting table

5-37

types

5-26

viewing data

5-26, 5-32

Assay Manual

- Preface-2

assay protocol file (APF) software overview

1-14

system overview

1-2

assays

APF

1-2

assay protocol file

1-2

calibrations

5-3

service

3-35

troubleshooting calibrations

5-37

attention safety statements

1-12

auto sample ID

3-34

automatic rerun configuring

3-37

disabling

3-37

enabling

3-37

pipettor choice

3-37

B

B

12

assay daily maintenance

7-12

special clean routine

7-17

back tab

1-26

backups daily maintenance

7-14

bar code errors resolving substrate

2-25

bar code labels position on tubes

3-40

reagent pack

2-62

sample container

3-40

bar codes scanning calibrator cards

5-16

scanning substrate bottles

2-24

batch requests

3-35

blue light status indicator

1-8

boxes selecting

1-31

UniCel DxI Operator's Guide bulk supplies button

1-23

consumables

2-3

liquid waste

2-42

overview

2-3

RVs

2-37

screen

2-6

solid waste

2-49

substrate

2-17

wash buffer

2-28

waste

2-3

buttons common window

1-31

comparison

6-5

QC

6-5, 6-9

quality control

6-9

routine processing

3-44

STAT processing

3-48, 3-49

to Help system

- Preface-4

C calibration curves

5-26

low RLUs

5-38

troubleshooting flat

5-38

viewing data

5-32

calibration cutoffs

5-26

viewing data

5-32

calibration data

also see assay calibrations

excluded replicates

5-32

most recent

5-27

screen

5-28

viewing

5-26, 5-32

calibration requests changing the reagent lot

5-25

entering

5-22

entering (flowchart)

5-24

required conditions

5-19

screen

5-20

calibrations assay calibrations

5-3

calibrator cards

5-10

scanning

5-16

calibrator levels editing

5-17

© 2022 Beckman Coulter, Inc.

C95317-AA

UniCel DxI Operator's Guide calibrator lots adding

5-12

deleting

5-18

expired

5-3

calibrators adding (flowchart)

5-15

adding lots

5-12

correcting information

5-10

deleting lots

5-18

editing levels

5-17

expired lots

5-10

multi-level

5-10

setting up

5-10

setup screen

5-11

carryover maintenance review screen

7-5

cautions about attention labels

1-12

description

- Preface-9

radio frequency

1-13

CCR result flag

4-27

CEX result flag

4-33

CISPR 11 compliance

1-13

clean routines cleaning solution warnings

7-17

daily maintenance

7-16

requesting maintenance

7-7

running

7-16

cleaning air filter

7-60

daily maintenance

7-12

liquid waste container

2-45

running clean routines

7-16

sample racks

A-3

wash towers

7-53

CLT result flag

4-28

CLX result flag

4-34, 5-4

comments assay calibrations

5-33

patient sample

3-36

QC charts

6-36

sample details

4-25

comparison button

6-5

QC charts

6-44

© 2022 Beckman Coulter, Inc.

C95317-AA

Index configurations automatic rerun

3-37

test results screen

4-10

continuous access

1-2

continuous sample report

4-51

printing

4-60

controls

see quality control

copy data entry

1-29

copy to disk

QC data

6-42

result data fields

4-40

test results

4-40

CRH result flag

4-34

CRL result flag

4-34

curves

see calibration curves

cutoffs

see calibration cutoffs

D daily clean system

7-16

daily maintenance clean routines

7-16

log

7-62

overview

7-3, 7-12

solid waste

7-15

system backup

7-14

test count

7-14

data entry copy

1-29

fields

1-29

paste

1-29

dead volumes calculations

A-5

requirements

A-5, A-7

RVs

A-5

sample containers

A-5, A-7

system

A-5

decontaminate liquid waste container

2-44

liquid waste drawer

7-58

substrate system

7-5

deflection aspirate probes

7-28, 7-39

Index-3

Index

Index-4

UniCel DxI Operator's Guide demographics sample details

4-25

DEX result flag

4-34

diluent packs expiration

4-34

expiration with LIS

4-36

reagent supplies

2-53

dilution factor manual entry

3-32

not in work pending

3-15

on reports

4-51

dilution test no dilution factor

3-32

QC for onboard dilutions

6-11

disks copying QC data

6-42

copying test results to

4-40, 4-41

dispense probes

10,000 test maintenance

7-45

electrical warning

7-45

inspecting

7-45

maintenance (flowchart)

7-48

positions

7-23, 7-34

potentially infectious

7-45

removing

7-45

downloading LIS requests

3-18

duck bill valve installing new

7-27

potentially infectious

7-23

removing used

7-23

replacing

7-23

replacing (flowchart)

7-29

wearing exposed metal warning

7-23

DxI system continuous access

1-2

documentation

- Preface-2

installation

1-8

instrument overview

1-3

navigation

1-15

overview

1-2

random access

1-2

regulatory statements

1-12

regulatory symbols

1-12

safety features

1-9

software overview

1-14

warranty

1-8

E

EIA-232

LIS overview

1-14

electrical wearing exposed metal warning

7-23

emisions statement radio frequency

1-13

entry methods

1-16

European Union

Notice to User

1-12

event log button

1-23

exceptions sample processing

3-10

expired calibrations

4-34

overriding

2-13, 5-3

processing with

2-13, 5-3

expired sample

3-15

expired supplies calibrator lots

5-3, 5-10

changing substrate

2-18

overriding

2-13

processing with

2-13

reagent packs

2-63

EXS result flag

4-34

external computer

1-15

F failed calibrations assay

5-4

assay troubleshooting table

5-37

troubleshooting

5-35

failure codes assay calibrations

5-36

fatal flags

4-27

rerunning cancelled tests

3-37

FCC rules compliance

1-13

fields data entry

1-28

display

1-28

list

1-28

filters assay calibration

5-6

© 2022 Beckman Coulter, Inc.

C95317-AA

UniCel DxI Operator's Guide description

1-29

laboratory-defined result

4-15

QC chart and data

6-34

quality control

6-7

reagent inventory

2-73

system-defined result

4-13

test result applying

4-13

test result defaults

4-13

test result defining

4-15

test result deleting

4-20

test result editing

4-15

test result overview

4-13

work pending

3-21

find function

Help system

- Preface-8

sample manager

3-12

test results

4-22

flags

see

result flags flash drive copying QC data

6-42

copying test results to

4-40, 4-41

flowcharts

10,000 test maintenance

7-32

5,000 test maintenance

7-22

adding a calibrator lot

5-15

aspirate probe cleaning

7-44

aspirate probe installation

7-41

assay calibrations

5-4

calibration requests

5-24

comparing QC charts

6-47

copying results

4-44

daily maintenance

7-13

defining result filters

4-19

deleting manual requests

3-59

deleting test results

4-49

dispense probes maintenance

7-48

duck bill valve replacement

7-29

editing manual test requests

3-57

editing result filters

4-19

liquid waste removal

2-46

LIS downloaded requests

3-19

loading routine racks

3-47

loading STAT racks

3-50

maintenance overview

7-4

manual test requests

3-33

QC test requests

6-25

© 2022 Beckman Coulter, Inc.

C95317-AA

Index quality control overview

6-4

reagent pack deleting

2-76

reagent pack loading

2-64

reagent pack unloading

2-66

reagent pack unloading all

2-69

RV adding

2-40

sample processing

3-4

sending results to LIS

4-47

solid waste removal

2-52

special weekly maintenance

7-20

substrate changing

2-23

test result finding

4-24

test result reports

4-59

test results overview

4-4

wash buffer changing

2-34

function buttons general function

1-27

main menu

1-19

not available

1-27

with menu

1-27

G green light status indicator

1-8

GRY result flag

4-34

H hazard safety symbols

1-9

Help

System

- Preface-2

help

also see Help

system button

1-25

technical support

- Preface-9

Help system accessing

- Preface-4

button bar

- Preface-7

description

- Preface-4

exiting

- Preface-5

find feature

- Preface-8

green text links

- Preface-6

help buttons

- Preface-4

link buttons

- Preface-5

supplies required screen

2-11

topics window

- Preface-8

using

- Preface-4

Index-5

Index

Index-6

HIV testing special weekly maintenance

7-19

host query

3-20

I

IND result flag

4-28

insert cups dead volume requirements

A-8

in sample tubes

3-43

loading

3-43

pediatric

A-3

preventing air bubbles

3-43

rack container type labels

A-8

rack sizes

A-3

inspections dispense probes

7-45

fallen RVs electrical warning

7-56

for fallen RVs

7-56

liquid waste drawer

7-58

pump connections at wash buffer reservoir

7-49

reagent pipettors

7-53

upper aspirate peristaltic pump connections

7-51

wash buffer supply drawer

7-59

installation aspirate probes

7-32

duck bill valve

7-27

DxI system

1-8

Instructions for Use

Instrument

- Preface-2

Instrument

Instructions for Use

- Preface-2

instrument

10,000 test maintenance

7-31

5,000 test maintenance

7-21

daily maintenance

7-12

DxI 600 illustration

1-4

DxI 800 illustration

1-3

overview

1-3

special weekly maintenance

7-19

temperatures

7-5

instrument software overview

1-14

interlock switches

1-9

UniCel DxI Operator's Guide

K keyboard equivalents

1-15

L labels

also see bar code labels

also see safety symbols

rack container type

A-7

sample racks

A-2

laboratory information system (LIS)

also see LIS

software overview

1-14

laser safety symbol

1-9

laser warning labels location

1-9

last run calibrations

5-27

LED Safety

1-13

Levey-Jennings charts

6-33

LEX result flag

4-35

lights amber status indicator

1-8

blue status indicator

1-8

green status indicator

1-8

red status indicator

1-7

liquid waste changing container (flowchart)

2-46

changing full container

2-43

changing in-use container

2-47

disposal

2-44

in-use container

2-47

monitoring levels

2-42

panel icon (DxI 800 only)

2-42

potentially infectious

2-41

removal

2-43

supply overview

2-41

liquid waste container flushing

2-45

liquid waste drawer inspection

7-58

location

2-41

potentially infectious

7-58

LIS editing requests at LIS

3-55

© 2022 Beckman Coulter, Inc.

C95317-AA

UniCel DxI Operator's Guide Index processing downloads

3-18

processing downloads (flowchart)

3-19

processing overview

3-3

querying for tests

3-20

sending results manually

4-45

software overview

1-14

work pending

3-15

load buttons

3-45

LOW result flag

4-35

LRH result flag

4-35

LRL result flag

4-35

M main menu function buttons

1-19

menu tab

1-16

software overview

1-16

workflow

1-19

maintenance

10,000 test interval

7-31

5,000 test interval

7-21

also see

maintenance routines daily

7-12

daily (flowchart)

7-13

log

7-62

overview

7-3

overview (flowchart)

7-4

preventive

7-4

requesting routines

7-7

requests screen

7-10

review screen

7-5

scheduling

7-14

special weekly

7-19

special weekly (flowchart)

7-20

temperature check

7-5

verification

7-30

maintenance log

7-62

binder

7-62

maintenance routines clean routines

7-7

DxI carryover

7-7

pipettor matching

7-7

requesting

7-7

run priority

7-10

running clean routines

7-16

system check routines

7-7

utility routine

7-6, 7-7

© 2022 Beckman Coulter, Inc.

C95317-AA

Manuals

Assay Manual

- Preface-2

Instrument Instructions for Use

-

Preface-2

Material Safety Data Sheet

- Preface-2

Operator’s Guide

- Preface-2

manuals

- Preface-2

Material Safety Data Sheet Manual

-

Preface-2

menu tab

1-26

menus main

1-16

tab

1-26

modes system mode descriptions

1-23

N

NCR result flag

4-29

non-fatal flags

4-33

not ready mode

1-23

Notice to User

1-12

O onload pusher motion indicator

3-44

Operator’s Guide

- Preface-2

options window selections

1-31

ORH result flag

4-35

ORL result flag

4-35

overdraw of sample

A-5

OVR result flag

4-36

P packs

see reagent packs

padlock icon reagent supplies screen

2-65

password protected calibrator lot deletion

5-18

control lot deletion

6-19

QC data point deletion

6-37

test result deletions

4-48

paste data entry

1-29

Index-7

Index

Index-8 patient IDs manual entry

3-31

report by

4-51

patient samples comments

3-36

potentially infections

3-39

patient test requests

3-25

rerunning

4-38

pause system command

1-27

paused mode

1-23

peristaltic pump connections inspection

7-51

electrical warning

7-51

potentially infectious

7-51

upper aspirate

7-51

PEX result flag

4-36

pipetting prevent air bubbles

3-43

plus (+) sign refresh screen

4-9

precision pump connections inspection

7-49

preventive maintenance

7-4

previous active calibrations

5-27

switching

5-32

processing tests

LIS downloaded

3-18

LIS downloaded (flowchart)

3-19

LIS query

3-20

manual test request entry

3-25

pump connections at wash buffer reservoir

7-49

electrical warning

7-49

potentially infectious

7-49

precision pump inspection

7-49

sample pump inspection

7-49

upper aspirate peristaltic pump inspections

7-51

wash pump inspection

7-49

Q

QC

also see

QC charts

also see

quality control

UniCel DxI Operator's Guide buttons

6-5, 6-9

calculations

6-28, 6-37

chart and data filter

6-34

chart and data screen

6-29

data collection for ranges

6-50

data copying

6-42

data report

6-38

data viewing

6-35

database

6-28

dilution tests

6-11

establishing ranges

6-50

flags

6-9

outliers

6-51

pipettor window

6-17

problems

6-53

processing overview

6-3

processing overview (flowchart)

6-4

range data evaluation

6-51

range establishment

6-50

range protocol

6-50

reagent lot assignment

6-27

rerunning a test

6-55

review report

6-10

reviewing data overview

6-28

rules

6-8

setup screen

6-12

status indicators

6-9

test replicates

6-22

test request editing

6-26

test request entry

6-21

test request entry (flowchart)

6-25

test requests overview

6-20

troubleshooting overview

6-53

troubleshooting results

6-53

Westgard QC rules

6-8

when to run

6-3

QC charts

6-28

comments

6-36

compare charts screen

6-45

comparing

6-46

comparing (flowchart)

6-47

comparison date change

6-48

comparison overview

6-44

data point deletion

6-37

data point omission

6-37

data screen

6-29

deleting comparisons

6-49

© 2022 Beckman Coulter, Inc.

C95317-AA

UniCel DxI Operator's Guide editing comparison dates

6-48

Levey-Jennings

6-33

report

6-38

saving comparisons

6-49

viewing

6-35

viewing comparisons

6-46

QCF result flag

4-36

QEX result flag

4-36

QNS result flag

4-29

QSB result flag

4-30

QSD result flag

4-30

QSS result flag

4-31

quality control

also see

QC adding a lot

6-13

button

1-23, 6-3, 6-9

comparison button

6-49

deleting

6-19

designating pipettors

6-17

editing a lot

6-13

initial expected values

6-16

list

6-10

material handling

6-50

material problems

6-54

materials

6-20

mean calculation

6-51

multi-analyte

6-22

multi-level set

6-21

naming

6-15

pipettors

6-17

screen

6-5

screen filter

6-7

SD calculation

6-51

setting up lots (overview)

6-11

query

LIS requests

3-20

Quick Reference Guide

Instrument Instructions for Use

-

Preface-2

R rack exceptions button

1-23

clearing

3-11

resolving errors

3-14

screen view

3-11

© 2022 Beckman Coulter, Inc.

C95317-AA

Index rack IDs changing manually entered

3-60

racks

see sample racks

radio frequency cautions

1-13

emissions statement

1-13

interference

1-13

random access

1-2

reaction vessels

see RVs

ready mode

1-23

reagent inventory applying a filter

2-73

deleting packs

2-75

overview

2-70

report printing

2-77

screen

2-71

screen filter

2-73

system tracking

2-70

reagent load door unlocking

2-65

reagent load tray in-use light

2-65, 2-68

reagent lots assigning for calibrations

5-25

assigning for QC

6-27

calibration

5-19

reagent packs

also see

reagent inventory automatic discard

2-70

bar code labels

2-62

deleting (flowchart)

2-76

deleting from inventory

2-75

details about

2-58

diluent packs

2-53

empty

2-63, 2-65

expired

2-63

in-use (padlock) icon

2-65

loading

2-60

loading (flowchart)

2-64

loading area

2-53

loading partial packs

2-64

mixing

2-61

monitoring supplies

2-54

partial packs

2-60, 2-64

Index-9

Index

Index-10 potentially infectious

2-53

removing all

2-68

report

2-58

storing partial packs

2-66

supply overview

2-53

supply status

2-54

unloading

2-65

unloading (flowchart)

2-66

unloading all

2-67

unloading all (flowchart)

2-69

used packs

2-64

reagent pipettors designating for controls

6-17

electrical warning

7-53

inspection

7-53

potentially infectious

7-53

reagent supplies

also see

reagent packs dispense monitoring

2-53

overview

2-53

report

2-58

screen

2-55

red light status indicator

1-7

refresh screen test results

4-9

regulatory statements

Notice to User

1-12

radio frequency emissions

1-13

replicates

QC

6-22

reports available

1-31

calibration

5-9

calibration data

5-34

continuous sample

4-56

heading information

1-33

patient

4-54

QC chart

6-41

QC data

6-40

QC review

6-10

reagent inventory

2-78

reagent supplies

2-59

sample

4-53

selected test results

4-55

supplies required

2-15

test results

4-50

work pending

3-24

UniCel DxI Operator's Guide requesting tests calibration

5-22

LIS download

3-18

LIS query

3-20

maintenance

7-8

manual entry

3-30

QC

6-21

rerunning

4-38

rerunning tests automatically after cancellation

3-25

configuring automatic rerun

3-37

patient

4-38

QC

6-55

reserve volume sufficient sample for

A-5

result flags corrective actions

4-27

descriptions

4-27

fatal

4-27

non-fatal

4-33

QC

6-9

troubleshooting

4-27

results

see test results

resume system command

1-27

RFX result flag

4-36

RLU result flag

4-31

routine maintenance

7-3

running mode

1-23

RVs adding

2-38

adding (flowchart)

2-40

inspection for fallen

7-56

loading

2-38

monitoring levels

2-37

panel icon (DxI 800 only)

2-37

partial bags

2-38

potentially infections

7-56

supply overview

2-36

used for

2-36

S safety features

DxI system

1-9

interlock switches

1-9

© 2022 Beckman Coulter, Inc.

C95317-AA

UniCel DxI Operator's Guide safety statements about attention labels

1-12

cautions

1-12

general

1-12

warnings

1-12

safety symbols

DxI instrument

1-9

laser

1-9

sample comments patient requests

3-36

sample containers bar code labels

3-40

dead volume requirements

A-7

matching to racks

3-41

missing

3-15

one type per rack

A-3, A-4, A-7

placing in racks

3-41

rack container type labels

A-7

rack sizes

A-3

remove caps

3-41, A-4, A-7

sample volume required

A-5

sample details troubleshooting

4-25

viewing

4-25

window

4-25

sample errors

3-14

sample IDs auto sample ID

3-34

manual entry

3-30

on sample manager screen

3-12

reusing

3-36

sequential assignment

3-34

unique

3-36

sample manager clearing exceptions

3-11

daily view

3-10, 3-11

date for daily view

3-11

exceptions view

3-10

finding sample IDs

3-12

in progress view

3-10

overview

3-3

requested view

3-10

resolving sample errors

3-14

screen

3-5

screen view selection

3-11

screen views

3-5, 3-10

test details

3-13

sample pipettor overdraw

A-5

© 2022 Beckman Coulter, Inc.

C95317-AA

Index sample presentation unit

see SPU

sample processing cancelling manual test requests

3-55

deleting samples

3-58

deleting samples (flowchart)

3-59

deleting test requests

3-58

editing manual test requests

3-56

editing requests overview

3-55

editing unscanned racks

3-56

errors

3-14

LIS download

3-18

LIS query

3-20

loading routine racks

3-44

loading STAT racks

3-48

monitoring progress

3-53

overview

3-3

overview (flowchart)

3-4

status

3-54

troubleshooting patient results

3-61

unloading racks

3-50

sample pump connections inspection

7-49

sample racks cancelling test requests

3-55

changing entered IDs

3-60

cleaning

A-3

container type labels

A-7

labels

A-2

loading correctly

3-46

loading overview

3-39

loading routine (flowchart)

3-47

loading routine samples

3-44

loading STAT (flowchart)

3-50

loading STAT samples

3-48

overview

A-2

processing overview

3-39

rack arms

3-45

sample container position

3-41

sample containers accepted

A-3

sizes

A-2

unloading

3-50

unloading overview

3-39

sample report

4-51

continuous

4-51

sample status descriptions

3-54

Index-11

Index

Index-12

UniCel DxI Operator's Guide sample tubes with insert cups

3-43

sample volume troubleshooting insufficient

4-29, 4-30,

4-31

sample volume calculation

A-5

saving system files

7-14

scanning procedures calibrator cards

5-16

substrate

2-24

scheduling maintenance by test count

7-14

daily

7-12

for HIV testing

7-19

screen elements back tab

1-26

common

1-22

fields

1-28

filters

1-29

function buttons

1-27

help button

1-25

menu tab

1-26

scroll bar

1-26

sort order

1-29

status line

1-29

system command buttons

1-27

system modes

1-23

system status buttons

1-23

screen views

Help system link button

- Preface-6

sample manager

3-10, 3-11

screens bulk supplies

2-6

calibration

5-5

calibration data

5-28

calibrator setup

5-11

common elements

1-22

maintenance requests

7-11

maintenance review

7-5

QC chart and data

6-29

QC setup

6-12

quality control

6-5

reagent inventory

2-71

reagent supplies

2-55

sample manager

3-5

software overview

1-15

supplies required

2-11

test requests

3-26

test requests for calibrations

5-20

test results

4-4

work pending

3-16

scroll bar

1-26

search

see find function

selection methods

1-16

on test results screen

4-11

service assays

3-35

Sodium Azide

Safe Handling

2-41

software installing

1-15

overview

1-14

removing

1-15

solid waste biohazard bag

2-51

changing container

2-50

changing container (flowchart)

2-52

daily maintenance

7-15

monitoring levels

2-49

panel icon (DxI 800 only)

2-49

potentially infectious

2-48, 2-50

removing

2-50

reset button

2-52

supplies overview

2-48

solid waste container changing

2-50

daily maintenance

7-15

location

2-48

potentially infectious

7-15

sort order

1-29

special clean

7-16

special weekly maintenance overview

7-3

procedure

7-19

procedure (flowchart)

7-20

SPU guide rails

3-45

offload areas

3-50

onload pusher motion indicator

3-44

STAT requests manual entry

3-32

status indicators amber light

1-8, 2-4

© 2022 Beckman Coulter, Inc.

C95317-AA

UniCel DxI Operator's Guide blue light

1-8

green light

1-8

lights

1-7

QC

6-9

red light

1-7

status line

1-29

stop button and status indicator

1-7

system command

1-27

substrate

2-24

adding

2-18

bar code errors

2-25

changing (flowchart)

2-23

changing empty bottle

2-18

changing expired bottle

2-18

changing in-use bottle

2-26

equilibration

2-16

equilibration area

2-22

in-use bottle

2-26

load tray

2-19

monitoring levels

2-16, 2-17

overview

2-16

panel icon (DxI 800 only)

2-17

partial bottles

2-26

scanning bar code

2-24

storage

2-16

switching bottles

2-26

supplies bulk

2-3

ordering

2-3

overview

2-3

reagent packs

2-53

RVs

2-37

substrate

2-16

wash buffer

2-27

supplies required button

1-23

critical instrument conditions

2-11

procedural Help link

2-11

report

2-15

screen

2-11

supply conditions overriding

2-13

overview

2-3

supply status amber indicator

2-4

bulk supplies button

2-5

© 2022 Beckman Coulter, Inc.

C95317-AA

Index liquid waste

2-42

monitoring

2-4

reagent packs

2-54

RVs

2-37

solid waste

2-49

substrate

2-17

supplies required button

2-5

system status buttons

2-5

system status panel (DxI 800 only)

2-4

wash buffer

2-28

symbols

also see

safety or regulatory symbols

SYS result flag

4-32

system backups daily maintenance

7-12, 7-14

system checks maintenance review screen

7-5

requesting maintenance

7-7

system command buttons descriptions

1-27

system console overview

1-3

system documentation cautions

- Preface-9

Help system

- Preface-4

presentation styles

- Preface-3

warnings

- Preface-9

system mode descriptions

1-23

system navigation enter

1-16

keyboard equivalents

1-15

main menu

1-16

overview

1-15

select

1-16

system overview

see DxI system

system status buttons bulk supplies

2-4

colors

1-23

descriptions

1-23

supplies required

2-4

supply status

2-5

system status panel (DxI 800 only) icons

2-5

location

2-4

monitoring supply status

2-4

Index-13

Index

Index-14

T tabs back

1-26

menu

1-26

technical support

- Preface-9

temperature nine thermal zones

7-5

printing report

7-7

reagent storage flag

4-37

sample wheel troubleshooting

4-37

substrate

2-16

troubleshooting incubator

4-32

troubleshooting substrate

4-33

troubleshooting wash carousel

4-33

test count daily maintenance

7-12

recording

7-14

scheduling maintenance

7-14

test details displaying

3-13

window

3-13

test interval maintenance (10,000) air filter

7-60

aspirate probes

7-32

dispense probes

7-45, 7-48

inspecting for RVs

7-56

installing clean aspirate probes

(flowchart)

7-41

liquid waste inspection

7-58

log

7-62

overview

7-31

overview (flowchart)

7-32

pump connections at wash buffer reservoir

7-49

reagent pipettors

7-53

upper aspirate peristaltic pump connections

7-51

verifying system performance

7-30

wash buffer inspection

7-59

wash towers

7-53

test interval maintenance (5,000) duck bill valve (flowchart)

7-29

duck bill valve replacement

7-23

log

7-62

overview

7-21

overview (flowchart)

7-22

verifying system performance

7-30

UniCel DxI Operator's Guide test lists batch request

3-35

test requests auto sample ID

3-34

batch request

3-35

calibration entry

5-22

cancelling manual requests

3-55

comments

3-36

deleting manual requests

3-58

editing manual requests

3-56

editing overview

3-55

editing requests (flowchart)

3-57

interrupted for STAT

3-49

LIS download

3-16

maintenance

7-7

manual entry

3-30

manual entry (flowchart)

3-33

monitoring progress

3-53

overview

3-25

patient

3-25

pending

3-16

processing LIS downloads

3-18

QC

6-20

QC editing

6-26

QC entering

6-21

querying the LIS

3-20

reagent lot for calibrations

5-25

reagent lots for QC

6-27

reusing sample IDs

3-36

sample information

3-25

screen

3-26

STAT entry

3-32

test status

3-54

test result filters applying

4-13

defining

4-15

deleting

4-20

edit filter window

4-16

editing

4-15

filter window

4-14

flowchart

4-19

overview

4-13

test results

also see test result filters

configuring screen

4-10

copying

4-40

copying (flowchart)

4-44

deleting

4-48

© 2022 Beckman Coulter, Inc.

C95317-AA

UniCel DxI Operator's Guide Index deleting (flowchart)

4-49

finding

4-22

finding (flowchart)

4-24

flags

4-27

managing

4-39

overview (flowchart)

4-4

printing (flowchart)

4-59

printing continuous sample report

4-60

printing reports

4-57

refreshing screen

4-9

report descriptions

4-51

reports

4-50

rerunning tests

4-38

reviewing (overview)

4-21

sample details

4-25

screen

4-4

screen report

4-51

selection

4-11

sending to LIS

4-45

sending to LIS (flowchart)

4-47

storing

4-39

troubleshooting flags

4-27

troubleshooting variability

3-64

test status descriptions

3-54

thermal zones

7-5

TRA result flag

4-37

TRI result flag

4-32

troubleshooting assay calibrations

5-37

patient sample results

3-61

QC results

6-53

result variability

3-64

sample details

4-25

test result flags

4-27

unexpected sample results

3-62

TRR result flag

4-37

TRS result flag

4-33

TRW result flag

4-33

U

UI software common screen elements

1-22

common window elements

1-30

navigation

1-15

overview

1-14

reports

1-31

screens

1-15

© 2022 Beckman Coulter, Inc.

C95317-AA system modes

1-23

windows

1-15

UniCel system

see DxI system

unload all packs

2-67

USB ports

4-41

user interface (UI)

see UI software

utility routine disabling

7-7

enabling

7-7

maintenance review screen

7-5

overview

7-3

running manually

7-6

V verification aspirate probe deflection

7-28, 7-39

LIS results column

4-10

sending LIS results

4-45

system performance

7-30

vessel hopper adding RVs

2-38

clearing fallen RVs beneath

7-57

location

2-36

W warning labels laser

1-9

Warnings

Sodium Azide

2-41

warnings about attention labels

1-12

description

- Preface-9

warranty

DxI system

1-8

wash buffer adding

2-29

changing (flowchart)

2-34

changing empty container

2-29

changing in-use

2-35

in-use container

2-35

location

2-27

monitoring levels

2-28

overview

2-27

panel icons (DxI 800 only)

2-28

Index-15

Index

Index-16

UniCel DxI Operator's Guide supply drawer inspection

7-59

switching

2-35

wash buffer reservoir pump connection inspection

7-49

wash pump connections inspection

7-49

wash towers cleaning

7-53

electrical warning

7-53

location

7-53, 7-54, 7-55

overflow reservoirs

7-55

potentially infectious

7-53

waste bulk

2-3

liquid

2-41

solid

2-48

weekly maintenance

7-19

Westgard QC rules

6-8

Levey-Jennings chart

6-33

window elements boxes

1-31

common

1-30

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

print (test results)

4-58

QC pipettor

6-17

request calibration

5-22

request maintenance

7-9

request QC

6-21

sample details

4-25

send to LIS

4-46

software overview

1-15

substrate bar code scan error

2-25

test details

3-13

unload all packs

2-67

work pending button

1-23

deleting tests

3-22

expired sample

3-15

filter

3-21

missing sample

3-15

no dilution factors

3-15

obstruction detected

3-16

overview

3-15

printing

3-23

report

3-23

rerunning patient tests

4-38

rerunning QC

6-55

screen

3-16

© 2022 Beckman Coulter, Inc.

C95317-AA

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