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TM

Access
Immunoassay System

Reference Manual

Revision 101740S
Revised May 2003
Printed in U.S.A.
Ó 2003 Beckman Coulter, Inc.
BECKMAN COULTER, INC. · FULLERTON, CA 92835
Publication Notes

Each page of this manual is identified with its revision and release date. For pages other than
the title page, revision information is located at the bottom of the page.

This manual includes pages from six revision releases. The pages listed below are issued as
revision 101740S, release date 5/03:
• This Title Page
• Pages 7 through 10
• Page 5-32
• Pages 6-8, 6-25, 6-32, 6-34 through 6-36, 6-38 through 6-40, 6-43, 6-45, 6-47, 6-70, and 6-86

The pages listed below are issued as revision 101740R, release date 10/01:
• Pages 2-10 through 2-11
• Pages 5-4 and 5-10
• Pages 7-12 through 7-17

The pages listed below are issued as revision 101740P, release date 04/01:
• Pages 5-3, and 6-21 through 6-22.

The page listed below is issued as revision 101740N, release date 10/00:
• Page 2-6

The pages listed below are issued as revision 101740M, release date 9/00:
• Pages 2-1 through 2-5

All other pages in this manual are issued as revision 101740L, release date 3/00.

This manual is intended for use with the Access Immunoassay System analyzer.

Access and the BECKMAN COULTER logo are trademarks of Beckman Coulter, Inc.
Table of Contents

Table of Contents

Preface Section Page


• Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

• Definition of System Documentation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

• Manual Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

• Safety Features. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

• Warranty Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

• Technical Support . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

• Ordering Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Introduction to Section Page


the Access
Immunoassay 1.1 Technology Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
System
1.2 Instrument Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5

1.3 System Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22

1.4 System Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-32

1.5 Bar Code Readers/Scanners . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-39

System Section Page


Specifications
and 2.1 Space and Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Performance
2.2 Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Characteristics

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L i
Table of Contents

Theory of Section Page


Operation
3.1 Sample Processing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

3.2 Reaction Vessel Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7

3.3 Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10

3.4 Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18

System Section Page


Diagnostics
4.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

4.2 Event Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

4.3 Diagnostics Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5

Trouble- Section Page


shooting
5.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

5.2 System Check Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

5.3 Instrument Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-15

5.4 Assay Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-24

System Support Section Page


Procedures
6.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

6.2 Substrate Decontamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3

6.3 Precision Pump Seal Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8

6.4 System Priming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-13

6.5 Archiving Data To Disk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16

6.6 System Reboot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18

6.7 System Check Support Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-21

6.8 Volume Checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-31

3/00 © 2000 Copyright Beckman Coulter, Inc.


ii Rev 101740L Access Reference Manual
Table of Contents

System Support Section Page


Procedures
(continued) 6.9 Opening and Closing the Top Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-49

6.10 Peristaltic Waste Pump Tubing Replacement. . . . . . . . . . . . . . . . . . . . . . . 6-53

6.11 System Shut Down and Restart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-57

6.12 Establishing Control Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-63

6.13 Special Clean Procedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-66

6.14 Incubator Belt Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-69

6.15 Main Pipettor Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-79

6.16 Replacing the Waste Filter Bottle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-85

System Section Page


Configuration
7.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2

7.2 Configure System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4

7.3 Configure Internal Bar Code Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11

7.4 Configure Laboratory Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-18

7.5 Configure Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-22

7.6 Configure Calibrators and Calibration Controls . . . . . . . . . . . . . . . . . . . . 7-31

7.7 Configure Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-38

7.8 System Configuration Worksheets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-46

LIS Interface Section Page

A.1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2

A.2 Configure LIS Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

A.3 Entering LIS Test Requests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7

A.4 Processing LIS Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-15

A.5 Sending Test Results to the LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-17

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L iii
Table of Contents

LIS Interface Section Page


(continued)
A.6 LIS Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-20

A.7 LIS Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-26

3/00 © 2000 Copyright Beckman Coulter, Inc.


iv Rev 101740L Access Reference Manual
List of Figures and Tables

List of Figures and Tables


Preface Table/Figure Page
Table P-1 Instrument Documentation in Available Languages . . . . . . . . . . . . . . 2

Table P-2 Ordering Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Introduction to Table/Figure Page


the Access
Figure 1-1 System Functionality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Immunoassay
System Figure 1-2 Top View–Revision A Fluidics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

Figure 1-3 Top View–Revision B Fluidics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

Table 1-4 Serial Numbers of Analyzers With Revision B Fluidics. . . . . . . . . . 1-7

Figure 1-5 The Carousel Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8

Figure 1-6 Main Pipettor Module–Revision A Fluidics. . . . . . . . . . . . . . . . . . . 1-10

Figure 1-7 Main Pipettor Module–Revision B Fluidics . . . . . . . . . . . . . . . . . . . 1-11

Figure 1-8 Analytical Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12

Figure 1-9 Fluidic Module–Revision A Fluidics . . . . . . . . . . . . . . . . . . . . . . . . . 1-14

Figure 1-10 Fluidic Module–Revision B Fluidics . . . . . . . . . . . . . . . . . . . . . . . . . 1-15

Figure 1-11 Unibase Fluids Tray . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16

Figure 1-12 Original Fluids Tray. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17

Figure 1-13 Electronics Module. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18

Figure 1-14 Peripheral Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20

Figure 1-15 Example Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24

Table 1-16 Screen Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24

Table 1-17 System Modes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26

Table 1-18 Status Icons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26

Table 1-19 Function Key Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-28

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L v
List of Figures and Tables

Introduction to Table/Figure Page


the Access
Table 1-20 Field to Field Key Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-29
Immunoassay
System Table 1-21 Within Field Key Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-29
(continued) Figure 1-22 Main Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-30

Table 1-23 Main Menu Active Function Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-30

Figure 1-24 Competitive Binding Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-33

Figure 1-25 Sandwich Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-34

Figure 1-26 Antibody Detection Assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-35

Figure 1-27 Specifications for Original Bar Code Reader Bar Code Label . . . . 1-40

Figure 1-28 Specifications for Wide Scan Bar Code Reader Bar Code Label . . 1-40

Figure 1-29 Tray ID Bar Code Label Placement . . . . . . . . . . . . . . . . . . . . . . . . . . 1-43

Figure 1-30 Original Sample ID Bar Code Label Placement . . . . . . . . . . . . . . . . 1-44

Figure 1-31 Wide Scan Sample ID Bar Code Label Placement . . . . . . . . . . . . . . 1-44

Theory of Table/Figure Page


Operation
Table 3-1 Sample Status Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

Table 3-2 Test State Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

Table 3-3 Tray Status Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5

Figure 3-4 RV Transport. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

Figure 3-5 Graphical Representation of Error Bands. . . . . . . . . . . . . . . . . . . . . 3-16

Table 3-6 Reasons for Calibration Rejection . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17

System Table/Figure Page


Diagnostics
Figure 4-1 Event Log. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4

Table 4-2 Event Log Screen Fields and Functions . . . . . . . . . . . . . . . . . . . . . . . 4-4

Figure 4-3 Diagnostics Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6

Table 4-4 Diagnostics Screen Fields and Functions . . . . . . . . . . . . . . . . . . . . . . 4-6

Figure 4-5 Example Alignment Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11

Figure 4-6 Example Incubator Belt Calibration Report . . . . . . . . . . . . . . . . . . . 4-15

3/00 © 2000 Copyright Beckman Coulter, Inc.


vi Rev 101740L Access Reference Manual
List of Figures and Tables

System Support Table/Figure Page


Procedures
Table 6-1 Substrate Decontamination Wait Times . . . . . . . . . . . . . . . . . . . . . . . 6-5

Table 6-2 Substrate Decontamination 1st Time Priming Cycles . . . . . . . . . . . 6-6

Table 6-3 Substrate Decontamination 2nd Time Priming Cycles. . . . . . . . . . . 6-7

Figure 6-4 Precision Pump. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9

Figure 6-5 Archive Data To Disk Flow Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17

Figure 6-6 Reset Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-18

Figure 6-7 Power Switch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-20

Table 6-8 System Check Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-21

Table 6-9 Washed Check Expected Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-26

Table 6-10 Substrate Check Expected Results. . . . . . . . . . . . . . . . . . . . . . . . . . . 6-28

Table 6-11 Unwashed Check Expected Results . . . . . . . . . . . . . . . . . . . . . . . . . 6-30

Figure 6-12 RV Shuttle Positions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-32

Table 6-13 Substrate Weight-to-Volume Conversion . . . . . . . . . . . . . . . . . . . . 6-33

Table 6-14 Substrate Volume Expected Results . . . . . . . . . . . . . . . . . . . . . . . . . 6-33

Table 6-15 Pipettor Weight-to-Volume Conversion. . . . . . . . . . . . . . . . . . . . . . 6-37

Table 6-16 Pipettor Volume Expected Results . . . . . . . . . . . . . . . . . . . . . . . . . . 6-37

Figure 6-17 Dispense Probes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-41

Table 6-18 Dispense Probe Weight-to-Volume Conversion . . . . . . . . . . . . . . . 6-42

Table 6-19 Dispense Probe Volume Expected Results. . . . . . . . . . . . . . . . . . . . 6-42

Table 6-20 Aspirate Probe Weight-to-Volume Conversion . . . . . . . . . . . . . . . 6-46

Table 6-21 Aspirate Volume Expected Results . . . . . . . . . . . . . . . . . . . . . . . . . . 6-46

Table 6-22 Aspirate Probe to Shuttle Position Correlation . . . . . . . . . . . . . . . . 6-46

Figure 6-23 Open Front Panel/Locate Captive Screw . . . . . . . . . . . . . . . . . . . . . 6-50

Figure 6-24 Open Top Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-51

Figure 6-25 Peristaltic Waste Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-54

Figure 6-26 Peristaltic Waste Pump with Removed Cassette . . . . . . . . . . . . . . . 6-55

Figure 6-27 Front Panel, Supply Cover, and Hex Screws . . . . . . . . . . . . . . . . . . 6-70

Figure 6-28 RV Load Door and Incubator Cover . . . . . . . . . . . . . . . . . . . . . . . . . 6-71

Figure 6-29 Incubator Belt Pulleys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-72

Figure 6-30 Original Incubator Belt, Vessel Holders, and Dovetail. . . . . . . . . . 6-73

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L vii
List of Figures and Tables

System Support Table/Figure Page


Procedures
Figure 6-31 Primary Probe Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-80
(continued)
Figure 6-32 Inserting Primary Probe into Probe Nut. . . . . . . . . . . . . . . . . . . . . . 6-81

Figure 6-33 Pipettor Torque Tool . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-82

Figure 6-34 Pipettor Gantry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-84

Figure 6-35 Waste Filter/Bottle Assembly in Unibase Fluids Tray . . . . . . . . . . 6-85

System Table/Figure Page


Configuration
Figure 7-1 System Configuration Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3

Table 7-2 System Configuration Screen Fields and Functions . . . . . . . . . . . . . 7-3

Figure 7-3 Configure System Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5

Table 7-4 Configure System Screen Fields and Functions. . . . . . . . . . . . . . . . . 7-5

Figure 7-5 Configure System Parameters Flow Chart . . . . . . . . . . . . . . . . . . . . . 7-7

Table 7-6 Available Bar Code Parameters Sorted by Bar Code Reader . . . . 7-12

Figure 7-7 Configure Bar Code Reader Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 7-14

Table 7-8 Configure Bar Code Reader Screen Fields and Functions . . . . . . . 7-14

Figure 7-9 Configure Laboratory Information Flow Chart . . . . . . . . . . . . . . . . 7-19

Figure 7-10 Configure Tests Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-24

Table 7-11 Configure Tests Screen Fields and Functions . . . . . . . . . . . . . . . . . 7-24

Figure 7-12 Configure Tests Flow Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-26

Figure 7-13 Add Calibrator Lot Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-33

Table 7-14 Add Calibrator Lot Screen Fields and Functions . . . . . . . . . . . . . . 7-33

Figure 7-15 Configure Calibrators Flow Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-35

Figure 7-16 Add Control Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-40

Table 7-17 Add Control Screen Fields and Functions . . . . . . . . . . . . . . . . . . . . 7-40

Figure 7-18 Configure Controls Flow Chart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-41

LIS Interface Table/Figure Page


Figure A-1 Configure LIS Interface Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4

Table A-2 Configure LIS Interface Screen Fields and Functions . . . . . . . . . . . . A-4

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viii Rev 101740L Access Reference Manual
List of Figures and Tables

LIS Interface Figure A-3 Configure LIS Interface Flow Chart. . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
(continued) Figure A-4 Manual LIS Test Request Entry Flow Chart . . . . . . . . . . . . . . . . . . . . A-8

Figure A-5 Automatic LIS Test Request Entry Flow Chart . . . . . . . . . . . . . . . . A-10

Figure A-6 Delete All LIS Test Requests Flow Chart . . . . . . . . . . . . . . . . . . . . . A-13

Figure A-7 Print All LIS Test Requests Flow Chart. . . . . . . . . . . . . . . . . . . . . . . A-14

Figure A-8 Sample Processing with LIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-16

Figure A-9 Manually Selecting and Sending Test Results to LIS Flow Chart . A-19

Figure A-10 LIS Diagnostics Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-21

Table A-11 LIS Diagnostics Screen Fields and Functions . . . . . . . . . . . . . . . . . . A-21

Figure A-12 LIS Connection Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-26

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L ix
List of Figures and Tables

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x Rev 101740L Access Reference Manual
Preface

Preface
This Preface contains the following information:
• Installation
• Definition of System Documentation
• Manual Conventions
• Safety Features
• Warranty Information
• Technical Support
• Ordering Supplies

Installation The Access Immunoassay System is installed by a qualified technical support


representative. Do not remove the analyzer from the shipping crate until the
technical support representative is present.

Definition of The Access Immunoassay System documentation and the system software are
System Docu- provided in four, 3-ring binders:
mentation • Access Immunoassay System Operator’s Guide
• Access Immunoassay System Reference Manual
• Access Immunoassay System Assay Manual (not available in Japan)
• Access System Software (the “LIS Vendor Information Document” and
updates may be distributed in this manual binder, but you would
forward them to your LIS vendor, as applicable)

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 1
Preface

Additional copies of the instrument documentation can be ordered by part


number in the available language of your choice, as shown in Table P-1. Beckman
Coulter will notify you as additional languages are available.

Document English French German Italian Spanish


Operator’s Guide 81516 81526 81536 81546 81556
Reference Manual 81519 81529 81539 81549 81559
Table P-1 Instrument Documentation in Available Languages

Operator’s Guide
The Operator’s Guide contains complete day to day operating instructions. Each
section begins with a brief description of the functions included in the chapter. If
appropriate, a flow chart of the steps necessary to complete a task is provided
followed by detailed text instructions.

Reference Manual
The Reference Manual contains detailed information about the Access System
including system specifications, performance characteristics, the theory of
operation, and instructions for configuring the Access System to suit the needs of
your laboratory. In addition, instructions are included for using the system
diagnostics section of the software and troubleshooting information to isolate and
correct system problems.

Assay Manual
The Assay Manual (not available in Japan) contains a product insert for each
Access System assay. The information presented includes a brief methodology
summary, a description of each assay component, reference ranges, and
performance characteristics. As new assays are released, a product insert for each
new assay is automatically sent to each Access System customer.

System Software
A technical support representative will install the system software on the analyzer.
A disk copy of the software is included in the System Software binder. Store this
binder in a safe, dry place away from intense heat and electrical and magnetic
fields.

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2 Rev 101740L Access Reference Manual
Preface

Manual The Access System manuals follow certain conventions, ensuring consistency
Conventions between the manuals and making the information in each easier for you to find.

Each page lists the chapter or section title at the top of the page, and the manual
title and revision level at the bottom of the page. Each chapter contains a table of
contents and several sections, each of which have a section number (for example,
Section 3.2 is the second section in Chapter 3). The text within sections can be
divided into subsections, indicated by a line separating the text, and a subsection
heading in the margin.

Operator keystrokes are indicated by bold typeface and brackets (for example,
[Enter]). Function keys are indicated in the same way, followed by the title of the
function key in bold typeface (for example, [F1] Test Request). Field and screen
names are capitalized.

Steps to perform a particular function are displayed in the text as either bullet
point steps:
• Perform this step.

or numbered steps:
1 Perform this step.

If a step is required for a function, a numbered box is used. If a step is optional for
a function, a bullet point is used.

Flow charts are integrated into the text to display the steps required to perform a
particular function in a concise, visual format. Arrows lead you through the flow
of steps. Screens are indicated by a rectangle with rounded corners containing the
screen name. Any point at which a decision is required is indicated by a diamond
containing the question to be decided.

Warnings, cautions, and notes are formatted as follows:

WARNING
Warnings are used when there is the possibility of harm to the operator.

CAUTION
Cautions are used when there is the possibility of damaging the analyzer.

NOTE
Notes are used to highlight or provide additional information.

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 3
Preface

Safety The Access Immunoassay System analyzer is designed to meet U.S. and
Features international safety standards. Safety labels are affixed to the instrument to alert
you to safety considerations, and interlock switches protect you from injury. Some
of the labels and interlock switches are described in the following sections.

A label with an exclamation point (see the following example) calls attention to
important information to read. The information is located either on the label or in
this manual. In this manual, text following the label example provides additional
information regarding safety conditions.

CAUTIONS
• The Access System generates, uses, and can radiate radio frequency
energy and if not installed and operated properly may cause interference
with other equipment. The Access Immunoassay System has been tested
and shown to be compliant with the requirements of 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. If interference with other equipment is
suspected, the operator must take whatever action is required to correct
the interference.
• In addition, other equipment may radiate radio frequency energy to
which the Access System analyzer is sensitive. Some suggested corrective
actions are:
– Move the equipment so there is a larger distance between the
equipment and the Access System analyzer.
– Re-orient the equipment with respect to the Access System
analyzer.
– Ensure the equipment is operating from a different power service
connector than that of the Access System analyzer.
• The Access System contains high leakage electrical current and should
always be plugged into an outlet with a third grounding hole. DO NOT
bypass the grounding prong on the plug.

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4 Rev 101740L Access Reference Manual
Preface

Canadian Standards Association Label

• The label of the Canadian Standards Association signifies that the Access
Immunoassay System meets all requirements for electrical safety and is
approved for use in the field.

General Electrical Safety Label

This label signifies an electrical shock hazard.


• High voltage is used to operate the ultrasonic probe.
• The luminometer contains a high voltage power supply which presents
a shock hazard. There are no operator serviceable parts in the power
supply box.
• The electronics module contains high voltage circuitry that operates the
ultrasonic probe. This circuitry presents a shock hazard if the electronics
module is opened. There are no operator serviceable parts in the electronics
module.

Biohazard Label

• The biohazard symbol indicates areas of the instrument and its associated
fluid handling equipment that may contain potentially infectious human
serum or blood products. Follow good laboratory practices in handling and
disposing of materials from these areas.

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 5
Preface

CE Mark Label

• A label with the CE mark of conformity is attached to the back panel of


Access Immunoassay System instruments. This label signifies that the
Access Immunoassay System complies with the EMC Directive 89/336/
EEC. New instruments manufactured after January 1, 1997 also comply with
the Low Voltage Directive 73/23/EEC.

Interlock Switch
In addition to safety labels, the Access System analyzer is equipped with an
interlock switch to protect the operator from injury. This interlock switch stops
movement, or prevents movement of mechanical parts when the switch is
activated.

The front panel interlock switch is activated when the panel is opened. The
interlock switch does not prevent opening the front panel; however, when the
panel is opened, the switch is activated and mechanical motion inside the
analyzer is stopped immediately. If this panel is opened when samples are being
processed, tests may be automatically cancelled by the system.

WARNING
The analyzer has moving parts and uses high voltage in the ultrasonics, each
of which presents an injury hazard. Therefore, the analyzer should not be
operated with the covers open.

Reaction Vessel Load Door Alarm


The reaction vessel (RV) load door will initiate an audible alarm if you open the
door without first pressing the appropriate function keys. When the appropriate
function key is pressed, the reaction vessel rake is moved to a location that allows
installation of reaction vessels (RVs). The rake will not move to the proper
location if the reaction vessel load door is opened without first pressing the
appropriate keys. If an audible alarm is heard when the reaction vessel load door
is opened, close the door and verify that the instrument is in the proper mode for
reaction vessel loading.

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6 Rev 101740L Access Reference Manual
Preface

Warranty The Access Immunoassay System is covered by and subject to the provisions of
Information the warranty included in your contractual agreement for the system and/or its
reagents.

Responsibility during the Warranty Period


The customer is responsible for the routine preventive maintenance described in
Chapter 8, Routine Maintenance of the Operator’s Guide. Repairs arising from the
failure to perform these maintenance procedures at the indicated time intervals
will be made at the discretion of Beckman Coulter, Inc. and at the customer’s
expense.

Technical For technical assistance regarding the Access Immunoassay System, contact
Support Beckman Coulter Technical Support at 800-854-3633 (in the U.S.A.) or your
technical support representative (outside the U.S.A).

Ordering Table P-2 is a list of Access System manuals and supplies, and their respective
Supplies catalog numbers. Also, available parts and tools that are referred to in the
Operator’s Guide or Reference Manual are included in the list.

Refer to the Quick Reference Guide or individual product inserts for the catalog
numbers for all Access System assay specific reagents.

Catalog
Product
Number

Access 1.0 mL/13 mm Insert Cups (1000) 81915


Access 1.0 mL/13 mm Insert Cup Caps (1000) 81920
Access 2.0 mL/13 mm Sample Cups (1000) 81902
Access 2.0 mL/16 mm Insert Cups (1000) 81917
Access 3.0 mL Sample Containers (500) 81914
Access 3.0 mL Sample Container Caps 81922A*
Access Chlamydia swab collection kit 973207
(see also Primary Access Chlamydia Collection Kit)
Access Chlamydia Insert Cups, 1.0 mL (1000) 81916
(Not needed if the primary Access Chlamydia Collection Kit is used.)
Access Chlamydia Cup Caps (1000) 81921
Table P-2 Ordering Supplies

© 2003 Beckman Coulter, Inc. 5/03


Access Reference Manual Rev 101740S 7
Preface

Catalog
Product
Number

13 mm Sample Trays (6) 81606


16x100 mm Sample Trays (6) 81608
16x75 mm Sample Trays (6) 81609
CARE kit 81641
Citranox** acid cleaner and detergent (1 gallon) 81912
Contrad** 70 cleaning solution (1 L) 81911
High Density disk, 3.5 inch, formatted for DOS (1) 81650
Keyboard templates English 101144C
French 81534
German 81544
Italian 81554
Spanish 81564
LIS Vendor Information document (English) 101968V*
Manuals:
Operator’s Guide See Table
P-1
Reference Manual See Table
P-1
Assay Manual*** CD (Multilingual; US and OUS) 387302
Assay Manual***--US; Paper, with binder 81518
Assay Manual***--Outside US; Paper, with binder 81598
Installation Implementation Guide (English) 973265
Maintenance and Service Log 973266
Material Safety Data Sheet (MSDS):***
English 973219
French 973220
German 973222
Italian 973223
Spanish 973221
Quick Reference Guide:
English 973220
Table P-2 Ordering Supplies (continued)

5/03 © 2003 Beckman Coulter, Inc.


8 Rev 101740S Access Reference Manual
Preface

Catalog
Product
Number

Nozzle/O-ring (for probe wash tower) 81051


Primary Access Chlamydia Collection Kit (100 swab packs) 34403
Printer cartridge for Hewlett Packard** (HP) DeskJet** 500 series 81623
printers
Printer cartridge for HP DeskJet 600, 670, and 695 series printers 8570A
Printer cartridge for HP DeskJet 800 series printers (black) 973051
Printer cartridge for HP DeskJet 800 series printers (color) 973097
Printer cartridge for HP LaserJet** 1200 series printers 386174
Probes/pipettors and supplies:
Aspirate probe, stainless steel universal 8409B*
Aspirate probe cleaning kit (syringe, fitting assembly, 80769
and 10 brushes)
Aspirate probe brushes, disposable (10) 973001
Dispense probe 8299B*
Pipettor torque tool 7343A*
Primary probe 5941A*
Substrate probe 7143C*
Reaction Vessels (16 cartridges @ 98 vessels each) 81901
Sample Tray Bar Code Label Kit - Contains 57 bar code labels 973052
(1 sheet) for each type of sample container.
Substrate (4 @ 130 mL each) 81906
Swab applicators, Texwipe** polyester (100) 104838
System Check Solution (6 @ 4 mL each) 81910
Tubing, aspirate probe (1 foot length) 79102
Tubing, peristaltic pump aspirate (1) 77372
Tubing, peristaltic pump vacuum, 2.79 mm (1) 77512
Vessel holders, chamfered (hole in top), no magnet (65) 973005
Vessel holder, Home position, chamfered, with magnet (1) 973006
Wash Buffer (4 @ 1950 mL each) 81907
Table P-2 Ordering Supplies (continued)

© 2003 Beckman Coulter, Inc. 5/03


Access Reference Manual Rev 101740S 9
Preface

Catalog
Product
Number

Wash Buffer valve assembly (dispense cap assembly) 6315B*


Waste Bags, reaction vessel (20) 81904
Waste Bottle with lid, without fittings (1) 6333A*
Waste filter/bottle assembly (1) 80171
Table P-2 Ordering Supplies (continued)

* Be sure you order the most current revision of this product.

** Citranox is a trademark of Alconox, Inc.


Contrad is a trademark of Decon Laboratories, Inc.
Hewlett Packard and DeskJet are trademarks of Hewlett-Packard Company.
Texwipe is a trademark of The Texwipe Company.

*** In Japan, the Assay Manual and Material Safety Data Sheets are not applicable. See your
local product inserts.

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10 Rev 101740S Access Reference Manual
Introduction to the Access Immunoassay System

1
Introduction to the Access
Immunoassay System
• Technology Overview (Section 1.1)............................................................ 1-2

• Instrument Description (Section 1.2).......................................................... 1-5

• System Software (Section 1.3).................................................................... 1-22

• System Assays (Section 1.4) ....................................................................... 1-32

• Bar Code Readers/Scanners (Section 1.5) ............................................... 1-39

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 1-1
Technology Overview

1.1
Technology Overview
The Access Immunoassay System automated analyzer features random access
capabilities. The processing protocol allows simultaneous use of instrument
resources to intermix processing various assays. For example, pipetting, washing,
and reading of multiple assays, in various stages, can take place concurrently. To
accomplish this task, the system allocates instrument resources prior to
processing using a real time multi-tasking environment.

Also, samples, reagents, and system supplies, except substrate, may be


replenished or waste emptied while the instrument processes samples with a
maximum throughput of 100 tests per hour.

The reaction vessel movements between the incubator belt and the wash/read
carousel permit the processing of a variety of assay methodologies. Variable
incubation times and reagent addition sequences allow for high flexibility in
assay development for maximum assay performance.

The Access System assays use paramagnetic particles for separation of free and
bound analyte fractions and a chemiluminescent substrate for light signal
generation. The amount of light produced is proportional or inversely
proportional to the concentration of the analyte being measured. Refer to
Section 1.4 and the individual product inserts for detailed information regarding
the assays.

The Access System consists of six “modules,” which execute the functions
necessary for processing patient samples, controls, calibration controls, and
calibrators. The relationship between the processing, control, and interface
functions and the modules that execute these functions are described in the
following sections and illustrated in Figure 1-1.

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1-2 Rev 101740L Access Reference Manual
Technology Overview

Processing Processing functions are performed by the following modules:


Functions • Carousel module—This module contains the samples to be processed
and the specific assay reagent packs.
• Main pipettor module—This module transfers appropriate aliquots of
sample and reagents, in a defined order, to the reaction vessels in the
analytical module. A single pipetting system and pump mechanism
delivers both high resolution (small volumes) and low resolution
(large volumes).
An ultrasonic probe tip provides the following functions:
- Level sensed sample delivery
- Reagent delivery
- Paramagnetic particle re-suspension in the reagent pack
- Mixing in the reaction vessel after reagent delivery (for some assays)
- Probe cleaning to minimize carryover
- Dilutions

• Analytical module—This module incubates and washes the samples and


reagents, adds substrate, and measures the light produced by the
chemiluminescent reaction. This measurement is then transmitted as an
electronic signal to the electronics module.
• Fluidic module—The fluidic module acts in concert with the main
pipettor module and the analytical module to dispense reagents and
samples, wash the samples and the primary probe, and dispense
substrate.

Control Control functions, which direct the operation of the processing modules, are
Functions performed by the electronics module. The electronics module contains an
interface circuit board assembly, which connects each of the processing modules
to the control modules. This allows the control modules to direct the actions of the
processing modules.

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 1-3
Technology Overview

Interface Interface functions are performed by the system software, directed through the
Functions peripheral module. The peripheral module includes the keyboard, monitor,
printer, external bar code wand, and external bar code scanner, which allow the
operator to request and monitor system functions via the system software.

PROCESSING FUNCTIONS

CAROUSEL MODULE MAIN PIPETTOR ANALYTICAL MODULE


• Reagent Carousel MODULE • Reaction Vessel Loader
• Sample Carousel • Main Pipettor • Incubator Belt
• Internal Bar Code • Precision Pump • Wash/Read Carousel
Reader/Tube Detector • Pipettor Gantry • Luminometer
• Ultrasonic Transducer

FLUIDIC MODULE
• Probe Wash Tower
• Wash Pump
• Waste Pump
• Substrate Pump
• Vacuum Pump
• Vacuum Reservoir
• Fluids Tray

CONTROL FUNCTIONS
ELECTRONICS MODULE
• Power Supply
• Printed Circuit Boards
• Floppy Disk Drive
• Hard Disk Drive
• Interlock Switches

INTERFACE FUNCTIONS
PERIPHERAL MODULE
• Keyboard
• Monitor System
• Printer Software
• External Bar Code Wand
• External Bar Code Scanner

Figure 1-1 System Functionality

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1-4 Rev 101740L Access Reference Manual
Instrument Description

1.2
Instrument Description
The Access System is comprised of the following modules:
• Carousel Module
• Main Pipettor Module
• Analytical Module
• Fluidic Module
• Electronics Module
• Peripheral Module

Each module is described in the following sections.

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 1-5
Instrument Description

Fluidic Module
Electronics Module

Carousel Module
Main Pipettor Module
Analytical Module

Figure 1-2 Top View–Revision A Fluidics

Fluidic Module
Electronics Module

Main Pipettor Module Carousel Module


Analytical Module

Figure 1-3 Top View–Revision B Fluidics

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1-6 Rev 101740L Access Reference Manual
Instrument Description

NOTE
There are two different fluids trays available. Refer to the Fluidic Module section
for a description and illustration of each tray.

Revision A There are two different revisions of the fluidic system used in the Access System.
and B The main differences are in the fluidic and main pipettor modules. Some
Fluidics maintenance, support, and troubleshooting procedures are different for revision
A and B fluidics. Refer to Table 1-4 and the illustrations of the main pipettor
(Figure 1-6 and Figure 1-7) and fluidic (Figure 1-2, Figure 1-3, Figure 1-9, and
Figure 1-10) modules to determine if your system has revision A or B fluidics.

400600 through 400604 400673 through 400678

400642 400760

400643 400770

400651 through 400659 400773

400664 400788

400665 400791

400668 400804 and higher

Table 1-4 Serial Numbers of Analyzers With Revision B Fluidics

Any serial numbers other than those in Table 1-4 are for analyzers with revision A
fluidics. If you cannot determine whether your system has revision A or B
fluidics, call Technical Support. Refer to the Fluidic Module section for a
description of the various components of this module.

Carousel Samples and reagent packs/vials on-board the analyzer are located on two
Module independently rotating carousels. The carousel module (Figure 1-5) is comprised
of these two carousels, the cup/tube detector, and the internal bar code reader.

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Access Reference Manual Rev 101740L 1-7
Instrument Description

Internal Bar Code Reader

Cup/Tube Detector

Reagent Carousel

Reagent Packs

Sample Carousel

Sample Tray

Figure 1-5 The Carousel Module

Sample Carousel
The sample carousel can hold up to 6 sample trays. Each tray contains 10 sample
positions for a total on-board capacity of 60 patient specimens, quality control
samples, calibrators, and/or calibration controls. Tray positions on the sample
carousel are accessed one at a time for loading and unloading sample trays. The
sample tray bar code labels provide positive sample tracking and indicate to the
system which sample containers are used (refer to Chapter 4 of the Operator’s
Guide for details).

Internal Bar Code Reader


After a sample tray is loaded onto the analyzer, the sample carousel rotates until
the tray passes the internal bar code reader and cup/tube detector. The internal
bar code reader scans the tray bar code to verify the Tray ID. The internal bar code
reader also scans bar code labeled sample containers. If a bar code cannot be read,
the Tray ID or Sample ID can be entered manually or can be scanned with the
external bar code wand. If a Sample ID scanned by the internal bar code reader is
different than a Sample ID manually entered previously for the sample in the Test
Request/Progress screen, the manually entered information will be used to
process the sample. Refer to Section 2, System Specifications and Performance
Characteristics, for acceptable bar code symbologies.

3/00 © 2000 Copyright Beckman Coulter, Inc.


1-8 Rev 101740L Access Reference Manual
Instrument Description

Two different internal bar code readers have been installed in Access Systems: the
original reader and a wide scan reader. The wide scan bar code reader differs from
the original reader with the following features:
• It allows placement of the bar code labels closer to the top of a sample
container.
• It requires a wider quiet zone on either side of the bar code.
• It reads sample containers in 16x75 mm sample trays.
• It accepts configuration of all bar code symbology parameters.

NOTE
For Access software version 3.27 or higher, you can enable available bar
code reader configurations by bar code symbology (refer to Chapter 7,
System Configuration, for detailed information). Successful programming
of available configurations depends on which internal bar code reader you
have.

Access analyzers with a serial number 401029 or higher have the wide scan bar
code reader installed. For analyzers with a serial number less than 401029, the
wide scan bar code reader may be installed by a technical support representative.
Analyzers with the wide scan bar code reader should have the words “Wide
Scan” in the comment line of the Internal Bar Code Reader field of the Configure
System Revisions screen (key sequence from the Main Menu: [F8] System
Config., [F1] System, [F8] Configure System Revisions, [Page Down] and/or
[Down Arrow] to Internal Bar Code Reader field).

Cup/Tube Detector
After a sample tray is loaded onto the analyzer, the sample carousel rotates until
the tray passes the internal bar code reader and the cup/tube detector. The cup/
tube detector scans for sample containers on the tray. If a sample container is not
detected on a scanned tray, but there is a test request entered for that tray position,
the test request is deleted.

Reagent Carousel
The reagent carousel holds up to 24 reagent packs/vial racks.

NOTE
Vials and vial racks are not available in all areas.

The carousel temperature is maintained at 3 to 10•C to allow on-board reagent


pack/vial rack storage. Reagent pack/vial rack positions are accessed one at time
for installation or removal of a reagent pack/vial rack.

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 1-9
Instrument Description

For reagent packs, the test name, lot number, expiration date, and serial number
are entered into the system manually or by scanning a bar code label on the
reagent pack. The bar code label is scanned using the external bar code wand as
you load the reagent pack on the carousel.

For reagent vial racks, the rack position, reagent code, reagent name, lot number,
serial number, and the expiration date are entered into the system manually or by
scanning the bar code labels printed on each reagent vial. Using the external bar
code scanner, all the vials on a rack can be scanned at the same time. Alternatively,
the bar code on each vial can be individually scanned using the external bar code
wand.

Main The main pipettor module (Figure 1-6 and Figure 1-7) is comprised of a pipettor
Pipettor gantry, main pipettor, precision pump, and ultrasonic transducer. The main
Module pipettor transfers samples, reagents, and wash buffer (for dilutions if necessary)
to the reaction vessels.

Precision Pump
Pipettor Gantry

Main Pipettor

Top View

Ultrasonic
Transducer

Primary
Probe
Front View Front View

Note: Devices have been simplified for illustration purposes.

Figure 1-6 Main Pipettor Module–Revision A Fluidics

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1-10 Rev 101740L Access Reference Manual
Instrument Description

Pipettor Gantry

Precision Pump Main Pipettor

Top View

Ultrasonic
Transducer

Note: Devices have been simplified


Primary
for illustration purposes.
Probe
Front View

Figure 1-7 Main Pipettor Module–Revision B Fluidics

Pipettor Gantry
The pipettor gantry supports the primary pipettor and allows horizontal motion
of the primary pipettor.

Main Pipettor
The main pipettor pipettes sample and reagents into the reaction vessels through
the primary probe. It is also used to prepare on-board sample dilutions. The main
pipettor allows vertical motion of the primary probe.

Precision Pump
The Access System uses a precision (dual resolution delivery) pump to achieve
accurate and precise delivery of both large and small fluid volumes. The precision
pump aspirates samples and assay specific reagents into the probe for delivery to
reaction vessels and delivers wash buffer for washing the probe and for preparing
sample dilutions.

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Access Reference Manual Rev 101740L 1-11
Instrument Description

Ultrasonic Transducer
The main pipettor is equipped with an ultrasonic transducer. Ultrasonic
vibrations are applied to the tip of the primary probe to: mix reagents in the
reagent pack before sampling, mix the contents of the reaction vessel, clean the
probe after each use, and detect the sample fluid level. Level sense is used to
determine the depth that the probe is immersed in solution or sample. Probe
immersion is minimized to reduce carryover.

Analytical The analytical module (Figure 1-8) is comprised of the reaction vessel supply,
Module reaction vessel loader, incubator belt, and the wash/read carousel. This module
transports and incubates reaction vessels during processing and washes and
reads the reaction vessels when incubation is complete.

Wash/Read Carousel
Luminometer

Incubator Track and Belt

Wash Arm

Reaction
Vessel
Waste
Bag

Reaction Vessel Reaction Vessel


Load Door Loader

Figure 1-8 Analytical Module

Reaction Vessel Loader


The reaction vessel loader consists of the reaction vessel shuttle and rake.
Reaction vessels are loaded into the instrument in cartridges containing
98 vessels. Up to 3 cartridges can be loaded into the vessel supply at a time for a
maximum capacity of 294 vessels. The system displays a warning if the vessel
supply is low and will not initiate sample processing if reaction vessels are not
available. Reaction vessels are preheated before assay reagents are added to
maintain optimum reaction conditions.

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Instrument Description

When [F4] Reaction Vessels is pressed from the Supplies or Supplies Required
screen, the interlock switch on the reaction vessel load door is released and the
reaction vessel rake is moved from the load area, allowing a reaction vessel
cartridge to be loaded. When a reaction vessel cartridge is placed in the
instrument and the reaction vessel load door is firmly pressed down on the
cartridge, then reaction vessels are removed from the plastic spine. Then, when
[F1] Done is pressed, the reaction vessel rake moves the vessels into the supply
area. The reaction vessel shuttle moves the vessels from the supply area into
position to allow the main pipettor to add the samples and reagents, then moves
the vessels onto the incubator belt.

Incubator Belt
The reaction vessels are carried on the incubator belt for a specified time period
defined by each assay protocol. The incubator temperature is controlled for
optimal assay conditions. After incubation, the vessel is transferred to the wash
station in the wash/read carousel. Refer to Section 3.2, Reaction Vessel Transport,
for a description of the wash cycle. If more processing is required after a wash
cycle but before the luminometer reading, the vessel is returned to the incubator
belt. After samples are read, the vessels are carried on the incubator belt to the
waste chute. The reaction vessel shuttle pushes the vessel from the incubator belt
and ejects it into the waste chute. The used vessels are collected in a disposable
waste bag. The system monitors the available space in the waste bag and alerts
the operator when the bag must be replaced.

Wash/Read Carousel
The wash/read carousel is comprised of the wash/read area, wash arm, three
aspirate probes, three dispense probes, substrate probe, separation magnets, and
luminometer.

When incubation is completed, the vessels are transferred to the wash/read


carousel for washing, addition of substrate, and luminometer reading.

The wash station contains three wash positions to maximize throughput. The
reaction vessels are transferred from the incubator belt to the first wash position
where the paramagnetic particles are washed according to the specific assay
protocol. The vessels are then moved to the second and third positions for
additional wash cycles. If necessary, the reaction vessel is returned to the
incubator belt for further processing.

If no further processing is required, the vessel is moved to the substrate addition


position. A single substrate addition position minimizes sample to sample
variability. The preheated Lumi-Phos* 530 substrate is added to the vessel to
initiate a chemiluminescent reaction. The reaction vessels are spun to mix the

* Lumi-Phos is a trademark of Lumigen, Inc.

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Access Reference Manual Rev 101740L 1-13
Instrument Description

contents. After the substrate is added, the vessels are incubated for a short period
as they advance to the luminometer.

Luminometer
The luminometer is a photo multiplier tube which measures the amount of light
produced by the chemiluminescent reaction in the reaction vessels. This
measurement is then transmitted as an electronic signal to the electronics module
for conversion into a calculated result in the appropriate units.

Fluidic The fluidic module (Figure 1-9 and Figure 1-10) consists of the wash, waste, and
Module substrate pumps and valves, vacuum pump and reservoir, fluids tray, and probe
wash tower. The function of each component is described as follows.

Substrate Valve
Vacuum
Pump Substrate Pump
Wash Pump Waste Pump
Vacuum Reservoir

Waste Valve

Probe Wash Tower


Wash Valve

Substrate Heater

Probe Wash
Valve

Fluids Tray

Figure 1-9 Fluidic Module–Revision A Fluidics

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Instrument Description

Vacuum Pump
Wash Pump

Vacuum Reservoir

Wash Valve
Substrate Valve,
Pump, and Heater

Probe Wash Tower

Probe Wash
Valve
Fluids Tray
Peristaltic Waste
Pump

0051E
Figure 1-10 Fluidic Module–Revision B Fluidics

NOTE
There are two different fluids trays available. Refer to the Fluids Tray section
below for a description and illustration of each tray.

Wash Pump and Valve


The wash pump and valve assembly dispenses wash buffer through the dispense
probes into the reaction vessel during wash cycles. This pump also dispenses
wash buffer to the probe wash tower.

Waste Pump and Valve


The waste pump and valve (the waste valve is present only in revision A fluidics)
remove liquid through the aspirate probes from the reaction vessels during wash
cycles. This pump also aspirates fluid out of the vacuum reservoir and into the
liquid waste bottle.

Vacuum Reservoir
The vacuum reservoir provides temporary storage for liquid removed from the
wash tower (both revision A and B fluidics). The waste pump then aspirates the
fluid out of the vacuum reservoir and into the liquid waste bottle.

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Instrument Description

Substrate Pump, Valve, and Heater


The substrate pump and valve dispense substrate, preheated in the substrate
heater, through the substrate probe into the reaction vessels.

Probe Wash Tower


The primary probe is thoroughly washed after each pipetting to minimize sample
carryover. Wash buffer is showered around the outside of the probe tip while the
inside of the probe is flushed. During washing, the ultrasonic transducer applies
ultrasonic waves to the probe to loosen residue and dry the probe.

Vacuum Pump
During probe washing, vacuum is applied to the wash tower to remove wash
buffer. As the primary probe is removed from the wash tower, vacuum is applied
to remove any droplets clinging to the outside of the probe.

Fluids Tray
There are two different fluids trays available for the analyzer, the unibase fluids
tray and the original fluids tray. Both fluids trays are located on the left side of the
analyzer; however, the components contained in the trays and the function of
some features differ. Figure 1-11 and Figure 1-12 are diagrams of the two fluids
trays.

The unibase fluids tray contains the liquid waste bottle, wash buffer bottle, wash
buffer reservoir, substrate bottles, a float level sensor for monitoring the wash
buffer volume, and a scale for monitoring the liquid waste weight. The unibase
fluids tray also contains the waste filter/bottle assembly, which filters
microscopic particles from the waste pump and vacuum pump exhausts.

Wash Buffer Bottle


Liquid Waste
Bottle

Substrate
Bottles Float Level Sensor

Waste Filter/Bottle
Assembly

Wash Buffer Reservoir

Figure 1-11 Unibase Fluids Tray

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Instrument Description

The original fluids tray contains the liquid waste bottle, wash buffer bottle, wash
buffer reservoir, and two capacity level sensors for monitoring the liquid waste
and wash buffer levels. The original fluids tray also contains the waste filter/
bottle assembly, which filters microscopic particles from the waste pump and
vacuum pump exhausts.

Waste Filter/Bottle Wash Buffer Bottle


Assembly

Liquid Waste
Bottle

Wash Buffer Reservoir

Figure 1-12 Original Fluids Tray

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Access Reference Manual Rev 101740L 1-17
Instrument Description

Electronics The electronics module (Figure 1-13) is comprised of printed circuit boards,
Module power supply, hard disk drive, floppy disk drive, reset button, an interlock
switch, and the reaction vessel load door alarm.

Power Supply
(under PCBs)

Printed Circuit
Boards (PCBs)

Reset Button

Hard Disk Drive Floppy


Disk Drive

Figure 1-13 Electronics Module

Reset Button
The reset button is located inside the front panel to the right of the main pipettor.
Pressing the reset button reboots the system (refer to Chapter 6, System Support
Procedures, for instructions on rebooting the system).

Printed Circuit Boards


The printed circuit boards (PCBs) control the video monitor, motor drivers,
ultrasonic transducer, heaters, temperature sensors, and luminometer.

Power Supply
The power supply provides and regulates the power for the system computer and
the electronic subsystems. The power supply is located underneath the printed
circuit boards.

Hard Disk Drive


The hard disk stores the system software and databases.

Floppy Disk Drive


The 3.5 inch, 1.44 megabyte floppy disk drive is used to install system software
upgrades and to archive data.

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Instrument Description

Interlock Switch
The analyzer is equipped with an interlock switch to protect the operator from
injury. This interlock switch stops movement, or prevents movement of
mechanical parts when the front panel of the analyzer is opened. If the front panel
is opened while samples are being processed, tests may be automatically
cancelled by the system.

WARNING
The analyzer has moving parts and uses high voltage in the ultrasonics, each
of which presents an injury hazard. Therefore, the analyzer should not be
operated with the covers open.

Reaction Vessel Load Door Alarm


The reaction vessel load door will initiate an audible alarm if you open the door
without first pressing the appropriate function keys. When the appropriate
function key is pressed, the reaction vessel rake is moved to a location that allows
installation of reaction vessels. The rake will not move to the proper location if the
reaction vessel load door is opened without first pressing the appropriate keys. If
an audible alarm is heard when the reaction vessel load door is opened, close the
door and verify that the instrument is in the proper mode for reaction vessel
loading.

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Access Reference Manual Rev 101740L 1-19
Instrument Description

Peripheral The peripheral module (Figure 1-14) consists of the external system accessories
Module for the analyzer.

Printer

Color Monitor

Articulated Arm

Keyboard

External Bar Code Wand

External Bar Code Scanner

Figure 1-14 Peripheral Module

Color Monitor
The color monitor provides high resolution screen text and graphics.

Articulated Arm
The articulated arm allows optimal positioning of the monitor and/or keyboard.

Keyboard
The keyboard is a standard 101 key model with full function key use.

Printer
The single sheet feed printer produces letter quality reports and graphics. Refer to
the printer manufacturer’s manual for details.

External Bar Code Wand


The external bar code wand is used to scan bar code labels on reagent packs,
sample containers (Sample IDs), sample trays (Tray IDs), calibrators, and
calibration controls, thereby automating information entry and reagent pack
inventory management. Refer to Chapter 2, System Specifications and
Performance Characteristics, for acceptable bar code symbologies.

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Instrument Description

External Bar Code Scanner (Optional, for Vials Only)


The external bar code scanner is an optional device that can be used to scan bar
code labels on reagent vials placed in a vial rack. This allows you to scan up to
eight vials at a time. You can also scan vials individually using the external bar
code wand or enter the reagent codes manually using the keyboard. Refer to
Chapter 2, System Specifications and Performance Characteristics, for acceptable
bar code symbologies.

NOTE
Vials are not available in all areas.

Peripheral Connections
The following table describes each of the peripheral connections (or ports) located
on the right side panel of the instrument. Each port on the instrument is labeled.

Port Description

LIS Port to which a laboratory information system (LIS) is


connected

COM4 Port to which the external bar code reader is connected

VGA Video output connector for the system monitor

DIAGNOSTICS Used for troubleshooting the instrument

PRINTER Port to which the printer is connected

KEYBOARD Port to which the standard 101 key, AT style keyboard is


connected

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Access Reference Manual Rev 101740L 1-21
System Software

1.3
System Software
The Access System software is your interface with the instrument. The software
functions are organized into a logical set of screens, all of which use a similar
format (Figure 1-15 and Table 1-16).

There are eight function keys represented along the bottom of each screen, each of
which corresponds to an active, or soft, function key on the keyboard (labeled [F1]
through [F8]). The functions of these keys change from screen to screen. If a
function is not currently available, the title of the key is displayed on the screen in
gray (instead of black). There are also seven function keys on the keyboard that
are constant throughout all screens (labeled [F9] through [F12], [Print Screen],
[Scroll Lock], and [Pause]). Refer to the Keyboard section later in this section for
detailed descriptions of the function keys.

The system software uses a three dimensional effect to indicate when data can be
entered into a field. If the field is recessed, you can enter information into that
field. If the field is raised, data cannot be entered into that field. For example,
when the Load Reagent Pack screen is displayed, the Reagent Pack Name field is
raised because data cannot be entered into that field. However, the Reagent Pack
Code field is recessed indicating that data may be entered into the field.

All screens have icons in the upper right and left corners of the screen. The icon in
the upper left corner displays the number of sample trays that are currently on-
board the analyzer. The icon in the upper right corner represents the system mode
(refer to Table 1-17 for a description of the system modes).

If the dialog window of the screen contains more information than can be
displayed at one time, a “scroll bar” is displayed along the right side of the dialog
window. The scroll bar contains a box indicating the location of the information
displayed in relation to all the available information. Use the [Page Up],
[Page Down], [End], and [Arrow] keys to “scroll” through the information.

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System Software

An underlined arrow character ( ) on the right side of a field indicates that the
field has several options which can be viewed and selected using one of two
methods:
• When the cursor is in the field, press the [Space Bar] to scroll through the list
of available options until the desired option is displayed, then press [Enter].
• When the cursor is in the field, press [Shift-F12] to display a Choice List of
available options, use the [Arrow] keys to highlight the desired option, then
press [Enter].

If the Screen Saver Delay option is enabled in system configuration, the system
will blank the screen if the keyboard has not been used for the defined period of
time (the screen will be black). To re-display the screen, press any key. If the
system mode changes, an icon is highlighted, or the reaction vessel load door is
opened while the screen is blank, the system will automatically re-display the
screen for the defined period of time. Refer to Section 7.2, Configure System, for
more information on the Screen Saver Delay option.

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System Software

On-board
Trays

Screen Title
System Mode

Dialog
Window

Status
Icons
Prompt Line
Active
Function Keys

Figure 1-15 Example Screen

Onboard Trays The round icon is divided into six sections which represent the sample
tray positions. One section is highlighted in blue for each on-board
sample tray.

Screen Title Contains the title, or name, of the screen.

System Mode An icon (depicted as a person) which represents the current system
mode. System modes are: READY (in starting block), RUNNING (running),
PAUSED (standing), and NOT READY (tying shoes). Refer to Table 1-17 for
a detailed description of each system mode.

Dialog Window Displays information which requires input and the information entered
in response to an inquiry. If input is required, such as a patient Sample
ID, the response will be displayed in the appropriate field in the Dialog
Window.

Table 1-16 Screen Features

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System Software

Status Icons Nine status icons convey information about various system parameters.
The icons from left to right represent the following:
• Wash Buffer
• Liquid Waste
• Reaction Vessels
• Substrate
• Supply Action Required
• Reaction Vessel Waste Bag
• Reagent Packs
• QC
• Event Log
Refer to Status Icons later in this section for a detailed description of
each icon.

Prompt Line Displays prompts, data entry instructions, and help messages as needed.

Active Function The active function keys, [F1] through [F8], are used to access the
Keys function indicated by their titles. For example, to enter test requests,
press [F1] Test Request/Progress from the Main Menu screen to display
the Test Request/Progress screen. Function keys may specify different
options depending on the screen displayed. These differences are
identified by the function key titles. Unlabeled function keys are not
active on that screen.

NOTE
In addition to the active function keys, there are eight fixed function
keys on the keyboard which perform the same functions from every
screen. For example, press [F9] to display the Main Menu from any
screen. Refer to the Keyboard section later in this section for a detailed
description of each key.

Table 1-16 Screen Features (continued)

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System Software

System To keep you informed of the system activities, or system mode, an icon is depicted
Modes in the upper, right-hand corner of each screen using a graphic representation of a
person. Descriptions of each mode follow.

READY The system is ready to begin processing samples.

RUNNING The system is performing a function (i.e., processing


samples or performing a maintenance or troubleshooting
procedure).

PAUSED The system continues current test processing, but no new


tests are scheduled (initiated).

NOT READY The system is not yet ready to process samples. The
system is checking the status of subsystems, initializing
motors, priming fluid lines, homing movable parts,
warming necessary modules, and/or requires
initialization.

Table 1-17 System Modes

Status Icons The status icons (refer to Table 1-18), located just above the function keys
displayed on the screen, convey information about various system parameters.
The background on which the icons are displayed is color coded (gray, yellow, or
red), depending on the icon and according to the urgency of attention required.
Normally, these icons are displayed on a gray background. The icons, from left to
right across the screen, represent the following:

Wash Buffer The system monitors the volume of buffer through a fluid
level sensor. There is no yellow warning status for this
icon. When the buffer level activates the sensor, the icon
background turns red, indicating that wash buffer must be
added. The Event Log icon is yellow and the Event Log
message states that the “scheduler” is paused (i.e., no new
tests are started).

Table 1-18 Status Icons

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System Software

Liquid Waste The system monitors the volume in the waste bottle. There
is no yellow warning status for this icon. When the waste
level activates the sensor, the icon background turns red,
indicating that the liquid waste bottle must be emptied.
The Event Log icon is yellow and the Event Log message
states that the “scheduler” is paused (i.e., no new tests are
started).

Reaction The system monitors the number of reaction vessels


Vessels available. When the number of reaction vessels available is
60 or less, the icon background is yellow. When no reaction
vessels are available, the icon background is red.

Substrate The system tracks the volume of substrate by monitoring


the number of tests processed after loading a new bottle.
(This includes substrate used for priming and daily
maintenance procedures.) When the number of tests that
can be processed with the current supply of substrate is 60
or less, the icon background is yellow. When the substrate
is empty, the icon background is red.

Supply The background of this icon turns red if the worklist being
Action initiated cannot run to completion without operator
Required intervention. You can press [F10] Supplies Required to get
more information. This icon may duplicate the warning
information given by the other status icons. Conditions for
the background of this icon to turn red include: insufficient
supply of reaction vessels or substrate and insufficient
space remaining in the reaction vessel waste bag. Test
processing is not affected. The background of this icon
returns to gray after the supply is replenished or the waste
bag is replaced.

Reaction The system tracks the number of reaction vessels ejected


Vessel into the reaction vessel waste bag. When there is room in
Waste Bag the bag for 60 vessels or fewer, the icon background is
yellow. When the bag is full, the icon background is red.

Reagent Packs The system monitors the number of tests processed using
each reagent pack and vial. There is no yellow warning
status for this icon. When there are not enough reagents in
the on-board reagent packs and/or vials to process the test
request, the icon background is displayed in red.

Quality Control There is no yellow warning status for this icon. If any
quality control sample is flagged, the icon background is
displayed in red until the QC Data screen is viewed. Test
processing is not affected.

Table 1-18 Status Icons (continued)

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System Software

Event Log The system monitors the status of various parameters,


such as voltage and temperature, and records pertinent
information in the Event Log. When a warning message is
logged, the icon background is yellow or red, and test
processing may or may not continue, depending on the
event which occurred. The icon background returns to
gray when the Event Log is reviewed.

Table 1-18 Status Icons (continued)

Keyboard The Access System keyboard is a standard computer keyboard. Text and numeric
entries are made by typing the information into the appropriate field. Some keys,
or combination of keys, perform unique Access System functions. These keys and
keystrokes are described in Table 1-19, Table 1-20, and Table 1-21.

Function Keys
[F1] - [F8] The functions these keys initiate will vary, depending on the displayed screen.
Called active (soft) function keys.

[F9] Displays the Main Menu from any screen.

[F10] Checks system status and displays the Supplies Required screen if a sample is
on-board the system for which there are insufficient supplies to process the
requested tests, or for which calibration is required.

[F11] Initiates sample processing.

[Shift - F12] Displays the Choice List. The Choice List contains the available options for the
field containing the cursor. An underlined arrow character is displayed on the
right side of every field for which you can view the Choice List.

[Esc] Exits the current screen and displays the previous screen. A confirmation
message is displayed if data was entered.

[Print Screen] Prints the currently displayed screen.

[Scroll Lock] Displays the Event Log which includes system messages.

[Pause] Pauses pipetting after pipetting is completed for the current sample. All other
processing continues.

[Shift - Pause] Stops the instrument and places the system in the NOT READY mode if the
system is running. In process tests are cancelled. If the system is not running,
this key sequence exits the user interface.
When this key is pressed, a confirmation screen is displayed. Press [Y] to stop
the instrument and cancel tests in progress or exit the user interface.

Table 1-19 Function Key Descriptions

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System Software

Field to Field Keys


[Right Arrow] Moves the cursor one field to the right.

[Left Arrow] Moves the cursor one field to the left.

[Up Arrow] Moves the cursor one field up.

[Down Arrow] Moves the cursor one field down.

[Enter] Moves the cursor one field to the right or one field down, depending on the
screen. This key also initiates actions from several windows.

[Tab] Moves the cursor one field to the right.

[Shift - Tab] Moves the cursor one field to the left.

Table 1-20 Field to Field Key Descriptions

Within Field Edit Keys


[Shift- Scrolls the field one character to the right if the entire field entry cannot be
Right Arrow] displayed.

[Shift- Scrolls the field one character to the left if the entire field entry cannot be
Left Arrow] displayed.

[Up Arrow] Scrolls the field one line up if the entire field entry cannot be displayed.

[Down Arrow] Scrolls the field one line down if the entire field entry cannot be displayed.

[Page Up] Moves the cursor one page up in a scroll region.

[Page Down] Moves the cursor one page down in a scroll region.

[Backspace] Deletes the character to the left of the cursor.

[Delete] Deletes the entire entry in a field.

[Home] In fields with a scroll region, displays the first page of data. In the Test Request/
Progress screen, moves the cursor to the Tray ID field.

[End] In fields with a scroll region, moves the cursor to the last line of data. In the Test
Request/Progress screen, moves the cursor to the Sample ID field of position 10.

Table 1-21 Within Field Key Descriptions

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System Software

Main Menu The Main Menu (Figure 1-22) is displayed at system startup. All system functions
are available from the Main Menu by pressing the appropriate function key, [F1]
through [F8] (Table 1-23). The system will respond by displaying the
corresponding screen. To return to the Main Menu from any screen, press the
[F9] Main Menu key.

Main Menu
1

Access®

TM

This program is protected by U.S. and international laws


as described in About Access
Copyright Beckman Coulter, Inc. 200X
Version X.XX

Test View Supplies Quality Calib. Maint. Diag. System


Request/ Test Control Review Config.
Progress Results Review
F1 F2 F3 F4 F5 F6 F7 F8

Figure 1-22 Main Menu

[F1] Test Select this option to enter sample information, select tests, review and edit the
Request/ test requests, load or unload sample trays from the system, select LIS samples
Progress for processing, clear trays, or review testing progress. Refer to Chapter 3 of the
Operator’s Guide for detailed information.

[F2] View Test Select this option to review, print, and archive patient results, and send them to
Results an LIS (refer to Appendix A for more information on the LIS interface). Refer to
Chapter 5 of the Operator’s Guide for detailed information.

Table 1-23 Main Menu Active Function Keys

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System Software

[F3] Supplies Select this option to review and update the inventory status of all system
supplies. Refer to Chapter 2 of the Operator’s Guide for detailed information.

[F4] Quality Select this option to review and print quality control results, Levey-Jennings
Control charts, and QC rule analysis of control data. Refer to Section 3.4, Quality
Review Control, of this manual and Chapter 7 of the Operator’s Guide for detailed
information.

[F5] Calibration Select this option to review and print calibration data. Refer to Section 3.3,
Review Calibration, of this manual and Chapter 6 of the Operator’s Guide for detailed
information.

[F6] Maintenance Select this option to perform routine maintenance procedures. Refer to
Chapter 8 of the Operator’s Guide for detailed information.

[F7] Diagnostics Select this option to perform system diagnostic procedures. Refer to Chapter 4,
System Diagnostics, for detailed information.

[F8] System Select this option to customize the Access System for your laboratory. Refer to
Configuration Chapter 7, System Configuration, for detailed information.

Table 1-23 Main Menu Active Function Keys (continued)

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Access Reference Manual Rev 101740L 1-31
System Assays

1.4
System Assays
All Access System immunoassays employ a paramagnetic particle solid phase
and an enzyme mediated chemiluminescent reaction for signal detection. The
solid phase and detection technologies allow measurement of a broad range
of analytes.

The Access System assays use a variety of protocols, the most common of which
are competitive binding, sandwich, and antibody detection immunoassay
methodologies. Figure 1-24, Figure 1-25, and Figure 1-26 illustrate these assay
types. Individual assays may use different formats; refer to the reagent pack insert
for the specific methodology used for each assay.

Each assay is optimized for rapid time to first result, with most tests completed in
15 - 30 minutes. Total assay time is dependent on incubation time and wash cycles
defined by the assay protocol.

Refer to the product inserts for detailed assay information.

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System Assays

Competitive Binding Assays

Mix paramagnetic particles,


monoclonal antibody,
conjugate, and sample in the
reaction vessel and incubate.

Immune complexes form.

Wash to remove
unbound components.

Add substrate, incubate, and


read. Amount of light
measured is inversely
proportional to the analyte
dioxetane-P dioxetane concentration in sample.

Legend

= Specific antibody directed = Paramagnetic particle coated


against analyte with capture antibody

= Analyte in sample

= Conjugate (analyte coupled = Wash 3 times


with alkaline phosphatase)

= Reaction between substrate and conjugate


dioxetane-P dioxetane produces light

Figure 1-24 Competitive Binding Assays

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Access Reference Manual Rev 101740L 1-33
System Assays

Sandwich Assays

Mix paramagnetic particles,


conjugate, and sample in the
reaction vessel and incubate.

Immune complexes form.

Wash to remove unbound


components.

Add substrate, incubate, and


read. Amount of light measured
is proportional to the analyte
dioxetane-P dioxetane concentration in the sample.

Legend

= Analyte in sample

= Conjugate (antibody directed against the analyte, coupled with


alkaline phosphatase)

= Paramagnetic particle coated with capture antibody and monoclonal


antibody directed against the analyte

= Wash 3 times

= Reaction between substrate and conjugate


produces light
dioxetane-P dioxetane

Figure 1-25 Sandwich Assays

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System Assays

Antibody Detection Assays

Mix paramagnetic particles and


sample in the reaction vessel and
incubate.

Immune complexes form.

Wash to remove unbound


components.

Add conjugate and incubate.

Immune complexes form.

Wash to remove unbound


components.

Add substrate, incubate and read.


Amount of light measured is
dioxetane-P dioxetane proportional to antibody
concentration in sample.

Legend

= Paramagnetic particle coated with analyte

= Antibodies in sample

= Wash 3 times

= Conjugate (antibody coupled with alkaline phosphatase)

= Reaction between substrate and conjugate produces light


dioxetane-P dioxetane

Figure 1-26 Antibody Detection Assays

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System Assays

Para- Micron size paramagnetic particles are used as the solid phase to separate the
magnetic bound from the unbound analyte. During wash cycles, magnets are used to pull
Particles the particles to the side of the reaction vessel to allow complete aspiration of the
wash fluid. The particles are re-suspended by adding wash buffer and then
spinning the vessel.

Chemilumi- Luminescence is defined as the emission of light associated with the dissipation of
nescence energy from an excited substance. There are different forms of luminescence
based on the excitation mechanism. Natural forms of luminescence include the
following:
• Photoluminescence, or fluorescence, which is caused by a substance
being stimulated by light.
• Bioluminescence, which is caused by an enzyme mediated chemical
reaction in living organisms, such as the firefly.
• Chemiluminescence, which is the product of a specific chemical reaction.

The Access System assays use Lumi-Phos 530, a dioxetane-based


chemiluminescent substrate. After addition of alkaline phosphatase, the substrate
is dephosphorylated, resulting in the release of light. The light produced is
directly proportional or inversely proportional to the amount of analyte present in
the sample, depending on the assay. The light emitted is measured by a
luminometer. The system converts this measurement into a sample test result.

Access The Access reagent pack contains enough reagents to perform up to 50 tests. Refer
Reagent to the product inserts or the reagent pack label to determine the number of tests
Packs included in each pack. The reagent packs are covered with an elastomeric layer to
maintain reagent integrity and prevent evaporation. This layer lightly reseals
after being punctured by the primary probe. However, the seal will not prevent a
punctured reagent pack from leaking if it is turned upside down.

Reagent packs should be stored upright in a refrigerator. Unpunctured reagent


packs should be gently inverted to remove any particles adhering to the seal
before being placed on the instrument. Once punctured, a reagent pack should
not be inverted. The analyzer can store up to 24 reagent packs on the reagent
carousel, which is maintained at 3-10•C. Refer to the product insert for detailed
storage and handling instructions.

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System Assays

The reagent packs are divided into five compartments or wells, denoted by letters
a - e. The paramagnetic particles are usually in well a. The contents of the
remaining wells and their letter assignments are assay-dependent.

Reagent packs are installed and removed using the Supplies, Reagent Inventory,
or Supplies Required (for loading only) screens. When a reagent pack is installed
on the reagent carousel, the bar code information is entered into the system with
the external bar code wand. Alternatively, the bar code information can be
entered manually. A bar code label on each reagent pack includes the following:
• Assay name
• Reagent pack lot number
• Expiration date
• Unique serial number

The system tracks the number of tests remaining in each reagent pack via the
serial number. A partially used reagent pack may be removed to make room for
other packs and then be re-installed later.

Access Some Access assays require the use of reagents from reagent vials. Each vial
Reagent Vials contains one reagent that is then used in conjunction with reagents from a
(Not “common” reagent pack.
Available in
Like reagent packs, reagent vials are loaded onto the reagent carousel. Before
All Areas) loading the vials onto the carousel, they must first be inserted into a reagent vial
rack that is specially designed to hold the vials. Vials can either be loaded into an
empty rack, or added to a rack that has already been loaded on the system (on-
board rack). After loading an off-board rack, the vials can be scanned as a group
on the external bar code scanner, and then loaded on the carousel.

Refer to the product inserts or the reagent vial label to determine the number of
tests included in each vial. The reagent vials are covered with an elastomeric layer
to maintain reagent integrity and prevent evaporation. This layer reseals after
being punctured by the primary probe. Reagent vials should be stored upright in
a refrigerator.

Because there must always be a common reagent pack installed along with the
reagent vials, 23 reagent vial racks with a maximum of 8 vials per rack can be
stored on the reagent carousel. Refer to the product insert for detailed storage and
handling instructions.

Vial racks are installed and removed by using the Supplies, Reagent Inventory, or
Supplies Required (loading only) screens. When a reagent rack is installed on the
reagent carousel, the bar code information of all the vials on a rack is entered into

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System Assays

the system using the external bar code scanner. Alternatively, the bar code
information can be entered manually or by using the external bar code wand.
A bar code label on each reagent vial includes the following:
• Reagent code
• Reagent vial lot number
• Expiration date
• Unique serial number

The system tracks the number of tests remaining in each reagent vial via the serial
number. A partially used reagent vial may be removed to make room for other
vials and then re-installed later.

The bar codes attached to the vial rack are used by the system to track vial
positions.

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Bar Code Readers/Scanners

1.5
Bar Code Readers/Scanners
This section describes the various ways in which bar codes can be used to enter
information. The Access System can be equipped with three bar code readers/
scanners:

• Internal bar code reader and cup/tube detector — automatically scans the
Tray ID bar code label to verify that the correct tray is loaded. When tubes
are detected on the sample tray, the internal bar code reader scans for
individual Sample ID bar code labels. Each Access System uses either the
original bar code reader or the wide scan bar code reader. Refer to the
Carousel Module heading in Section 1.2 for more information about these
two readers.

• External bar code wand — allows you to scan Tray IDs, Sample IDs, and
calibrator, calibration control, and reagent pack /vial information contained
on bar code labels.

• External bar code scanner (for reagent vials only) — allows you to scan
information contained on the bar code labels of all the reagent vials loaded
on a reagent rack at one time.

The internal bar code reader is configured on and off and bar code reader
parameters are enabled in system configuration (refer to Chapter 7, System
Configuration). The external bar code wand and scanner are always on when they
are connected to the analyzer.

Bar Code Bar code labels consist of vertical black bars (the bar code) and the equivalent
Label characters. Figure 1-27 and Figure 1-28 are illustrations of bar code labels with the
Requirements specifications required for successful reading by the original bar code reader and
the wide scan bar code reader.

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Access Reference Manual Rev 101740L 1-39
Bar Code Readers/Scanners

Quiet zones (min. 0.10 in.


or 0.25 cm each)

Height
(min. 0.39 in. Bar code
or 1 cm) ABC123456789 Bar code characters

Length (max. 3.00 in. or 7.5 cm)

Figure 1-27 Specifications for Original Bar Code Reader Bar Code Label

Quiet zones (min. 0.20 in.


or 0.50 cm each)

Height
(min. 0.39 in. Bar code
or 1 cm) ABC123456789 Bar code characters

Length (max. 3.00 in. or 7.5 cm)

Figure 1-28 Specifications for Wide Scan Bar Code Reader Bar Code Label

The characters received into a field when a bar code label is scanned are identical
to the characters printed below the bar code, excluding bar code check digits or
start and stop characters when those parameters are disabled in system
configuration.

Sample tube bar code labels are not provided, but must adhere to the
specifications illustrated in Figure 1-27 and Figure 1-28. Sample tray bar code
labels matching the specifications above are provided with the sample trays,
allowing you to assign Tray IDs according to the type of sample container you
plan to use. Refer to Chapter 4 of the Operator’s Guide for information on the types
of containers you can use and the Tray IDs associated with each. Refer to Chapter
2, System Specifications and Performance Characteristics, for the bar code
symbologies acceptable for use with the Access System bar code readers.

Internal Bar When you press [F1] Done after loading the sample tray onto the analyzer, the
Code Reader sample carousel rotates the tray to the internal bar code reader. If the bar code
reader/tube detector is configured on, the sample tray is scanned for a Tray ID
bar code. The Tray ID indicates to the system the type of sample container used
(refer to Chapter 4 of the Operator’s Guide for details). If the Tray ID bar code does
not match the Tray ID displayed in the Test Request/Progress screen, a message is
displayed stating that the wrong tray was loaded.

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Bar Code Readers/Scanners

If the Tray ID bar code matches the Tray ID displayed in the Test Request/
Progress screen, the cup/tube detector checks for sample containers loaded on
the tray.
• If a sample container is detected and the Sample ID field is blank, the sample
container is scanned for a bar code label and the bar code value is inserted
into the Sample ID field. Tests that have been requested from the LIS are
downloaded, or you can manually select test IDs for the sample and enter
the remaining sample information.
• If a sample container is not detected, and there is a test request entered for
that tray position, the test request is deleted from the Test Request/Progress
screen.

With the internal bar code reader/tube detector configured on, you can add
samples to on-board trays (refer to Chapter 4 of the Operator’s Guide for details).

External Bar The external bar code wand can be used to enter information provided on bar
Code Wand code labels for the following items:

• Tray IDs
• Sample IDs
• Reagent pack/vial information
• Calibration control information
• Calibrator information

To scan a bar code with the external bar code wand, use the following technique:

1 Place the cursor in the appropriate field of the appropriate screen before
scanning the bar code.

2 Place the tip of the wand at an angle on the quiet zone of the bar code. (Refer
to Figure 1-28 for an illustration of a bar code with quiet zones.) With the
wand at a proper angle, you can see a small, oval pattern of light extending
from the tip of the wand within the quiet zone.

3 Move the tip of the wand smoothly and rapidly across the bar code to the
quiet zone on the other side. The external bar code wand beeps after reading
a bar code.

NOTE
Keep the light focused within the lines of the bar code. If the light extends
across the edge of either side of the bar code, the bar code may not be read
successfully.

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Access Reference Manual Rev 101740L 1-41
Bar Code Readers/Scanners

4 Look at the screen and verify that the bar code is correctly displayed in the
proper field.

Alternatively for Sample IDs, you can manually enter the Sample ID or use the
internal bar code reader to scan the bar code label. During test request entry,
Sample ID bar codes can be entered for an entire tray at one time using the
internal bar code reader. Refer to Entering Sample IDs for a Tray later in this
section for detailed instructions.

Alternatively for reagent pack/vial, calibration control, or calibrator information,


manually enter the bar code information.

External Bar The external bar code scanner can be used to enter information provided on the
Code bar code labels of reagent vials that have been loaded onto a reagent vial rack,
Scanner eliminating the need to type the information into a field on the Load Vial Rack
(for Reagent screen. Place the cursor in the appropriate field before scanning the bar codes.
Vials Only) Alternatively, scan each bar code with the external bar code wand, or manually
enter the bar code information.

NOTE
The external bar code scanner can only scan vial racks. Do not attempt to use it to
scan reagent packs.

Attaching The sample tray bar code labels must be placed on the tray as follows to ensure
Tray ID Bar that they can be read properly by the internal bar code reader. The Tray ID
Code Labels indicates to the system the type of sample container used (refer to Chapter 4 of the
Operator’s Guide for details).
1 Lay the sample tray on a table so that the ends of the tray curve towards
the table.

2 Locate the center spine of the tray. The center spine is located directly below
the handle of the tray and divides the 10 sample positions into two sets of 5.

3 Locate the indentation on the spine that indicates the correct location for the
bar code label.

4 Align the bar code label with the indentation and attach the label securely to
the tray with the bar code nearest the handle of the tray and the
corresponding number underneath it (refer to Figure 1-29).

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Bar Code Readers/Scanners

05

05

0-1 mm
05

Figure 1-29 Tray ID Bar Code Label Placement

Attaching The Sample ID bar code labels must be placed on the sample containers as follows
Sample ID Bar to ensure that they can be read properly by the internal bar code reader. The
Code Labels procedure for attaching the bar code label to a sample container differs depending
on which internal bar code reader is installed in the system. The internal bar code
reader automatically discriminates between symbologies, so samples with bar
code labels using different symbologies can be included on the same tray.

You may need to enable parameters for the bar code symbologies you use. Refer
to Chapter 7 for bar code configuration information.

Original Bar Code Reader


1 Place the sample tube in the tray and note the position of the Tray ID bar
code label with respect to the sample container.

2 Remove the sample container from the tray.

3 Place the bar code label on the sample container so that the label is at least
0.25 inches from the bottom of the sample container and is at the same height
as the Tray ID bar code label (refer to Figure 1-30).

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Access Reference Manual Rev 101740L 1-43
Bar Code Readers/Scanners

Level with top of tray ID


bar code label

ABC123456789
Min. distance = 0.25 in. or 0.6 cm

Figure 1-30 Original Sample ID Bar Code Label Placement

4 Ensure that the label is aligned vertically on the sample container and is
securely fastened to the tube.

5 Place the sample container in the tray and ensure that the Sample ID bar
code label and the Tray ID bar code label are at the same height in relation
to the tray and that the Sample ID bar code label is centered in the sample
position for maximum visibility.

Wide Scan Bar Code Reader


1 Place the bar code label on the sample container so that the label is at least
0.25 inches from the top and bottom of the container (refer to Figure 1-31),
and ensure that it is securely fastened.

Min. distance = 0.25 in. or 0.6 cm


ABC123456789

ABC123456789

Min. distance = 0.25 in. or 0.6 cm

Figure 1-31 Wide Scan Sample ID Bar Code Label Placement

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Bar Code Readers/Scanners

2 Place the sample container in the tray and ensure that the Sample ID bar
code label is centered in the sample position for maximum visibility.

Entering The Sample IDs for an entire tray can be entered at one time when the internal bar
Sample IDs code reader is configured and the samples are bar code labeled. Sample IDs can
for a Tray also be entered into the test request using the external bar code wand. Refer to
Chapter 3 of the Operator’s Guide for detailed instructions.

To use the internal bar code reader to enter Sample IDs:

1 Press [F1] Test Request/Progress from the Main Menu.

The Test Request/Progress screen is displayed with the cursor in the


Tray ID field.

2 Type the Tray ID, then press [Enter].

3 Load the samples with bar code labels onto the selected sample tray.

4 Press [F1] Load Tray.

5 Load the sample tray onto the analyzer, then press [F1] Done.

The sample carousel rotates until the sample tray passes the internal bar
code reader and cup/tube detector. The internal bar code reader scans the
Sample ID bar code labels and inserts the Sample IDs into the appropriate
Sample ID field in the Test Request/Progress screen.

6 Enter the remaining information for each sample.

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Access Reference Manual Rev 101740L 1-45
Bar Code Readers/Scanners

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1-46 Rev 101740L Access Reference Manual
System Specifications and Performance Characteristics

2
System Specifications and
Performance Characteristics
• Space and Environmental Requirements (Section 2.1) ............................ 2-2

• Performance Characteristics (Section 2.2).................................................. 2-6

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Access Reference Manual Rev 101740M 2-1
Space and Environmental Requirements

2.1
Space and Environmental
Requirements
This section describes the spatial, environmental, and electrical requirements for
the Access System.

Instrument • Instrument dimensions Width = 39 inches (99 cm)


Space Height = 18.5 inches (47 cm)
Requirements Depth = 24 inches (61 cm)
• Instrument weight 200 lbs (91 kg) (dry)
• Clearance 2 inches (5 cm) at rear and on sides,
24 inches (61 cm) on top
• Keyboard dimensions Length = 18.25 inches (46 cm)
Height = 1.38 inches (4 cm)
Depth = 8.16 inches (21 cm)
• Monitor dimensions Width = 14.1 inches (36 cm)
(Sampo Technology, Inc. Height = 13.3 inches (34 cm)
model KM-411N is Depth = 14.5 inches (37 cm)
provided currently) Supported on an integrated articulated arm.
• Monitor weight 25 lbs (11.3 kg)
• Printer dimensions
HP 840C Width = 17.5 inches (44 cm)
Height = 7.3 inches (18 cm)
Depth = 14 inches (36 cm)
HP 810C Width = 18 inches (45 cm)
Height = 7.5 inches (19 cm)
Depth = 14 inches (36 cm)
HP 600, 670, or 695C Width = 17.2 inches (43.6 cm)
Height = 7.9 inches (19.9 cm)
Depth = 16 inches (40.5 cm)

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2-2 Rev 101740M Access Reference Manual
Space and Environmental Requirements

HP 500, 505J (Japanese), Width = 17.3 inches (44.0 cm)


520, or 540 Height = 8 inches (20.2 cm)
Depth = 14.8 inches (37.7 cm)
HP 560J (Japanese) Width = 44.3 cm
Height = 20.6 cm
Depth = 38.9 cm
Epson* MJ-930C (Japanese) Width = 47.5 cm
Height = 17.7 cm
Depth = 27.4 cm
• Printer weight
HP 810C or 840C 12.5 lbs (5.7 kg)
HP 600, 670, or 695C 11.6 lbs (5.3 kg)
HP 500, 505J (Japanese), 14 lbs (6.5 kg)
520, or 540
HP 560J (Japanese) 6.6 kg
Epson MJ-930C (Japanese) 6.5 kg (without ink cartridge)

Operating • For indoor use only.


Environment • Humidity Operational: 20 to 80%
Requirements Exposure: 10 to 80%
• Maximum altitude Operational: 6,500 feet (2,000 m)
Exposure: 40,000 feet (12,200 m)
• Temperature Operational: 18°C to 32°C (64°F to 90°F)
Exposure: -30°C to 50°C (-22°F to 122°F)
• Maximum ambient 2°C per 30 minutes
temperature change rate
• Ambient light Results not affected by ambient light levels
between 0 - 200 foot-candles.
• Pollution degrees 1 and 2, in accordance with IEC 664.

Electrical The Access System can operate from any line supplying either 115-120 VAC at
Requirements 15 amps or 220-240 VAC at 6 amps, at either 50 or 60 hertz (Hz), single phase
power.

The single phase line should meet the following requirements:


• Dedicated line (no other equipment may be connected to this line)
• Line voltage fluctuations not to exceed ±10 VAC per cycle

* Epson is a trademark of Seiko Epson Corporation, Epson Hanbai Co., Ltd.

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Access Reference Manual Rev 101740M 2-3
Space and Environmental Requirements

• Line voltage sags not to fall below 90 VAC (115-120 VAC line) or 180
VAC (220-240 VAC line)
• Line voltage surges not to exceed 135 VAC (115-120 VAC line) or 250
VAC (220-240 VAC line)
• Line protection device should be a circuit breaker rated 15 amps (115-120
VAC line) or 6 amps (220-240 VAC line)
• Maximum voltage between the neutral conductor and the safety ground
conductor should not exceed 2 VAC RMS
• Maximum resistance between the safety ground conductor and an
accessible building safety ground should not exceed 0.1 ohms
• The outlet should be located within 1.5 m (5 feet) of the Access System.
• Transient overvoltages, according to UL 3101 Installation Categories
(Overvoltage Categories) I and II.

The line must supply the correct voltage to operate the Hewlett Packard DeskJet
printer used with the Access System, or damage to the printer may occur. The
printer is supplied as either a 115-120 VAC or a 220-240 VAC unit.

Access System Environmental Data


• Power consumption and heat production in British thermal units (BTUs)
with HP 600, 670, or 695C printers
Device Power (watts) Heat Output (BTU/hour)
Instrument 800 2730
Monitor 120 410
Printer 12 41
TOTAL 932 3181

• Power consumption and heat production with HP 500, 505J, 520, 540, 560J,
810C, or 840C printer
Device Power (watts) Heat Output (BTU/hour)
Instrument 800 2730
Monitor 120 410
Printer 25 85
TOTAL 945 3225

• Power consumption and heat production with Epson MJ-930C printer


Device Power (watts) Heat Output (BTU/hour)
Instrument 800 2730
Monitor 120 410
Printer 20 68
TOTAL 938 3208

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2-4 Rev 101740M Access Reference Manual
Space and Environmental Requirements

• Line current consumption


Instrument and monitor @ 110 VAC: 10 amp max.
Printer @ 110 VAC: 1 amp max.

Surge Suppressors
Beckman Coulter, Inc. does not recommend the use of surge suppressors with the
Access System. The Access System incorporates protection similar to that
provided by a surge suppressor.

Line Conditioning Transformers


If AC (alternating current) power line problems are suspected, Beckman Coulter,
Inc. recommends the use of a line conditioning transformer incorporating local
ground isolation. Line conditioning transformers provide several features,
including isolated local ground and high frequency isolation.

If a line conditioning transformer is used, ensure that the specifications meet the
following requirements:
Minimum output capacity: 1300 volt amperes (VA)
Output voltage: 120 or 240 VAC
Output frequency: 50 or 60 Hz, single phase
Output wave form: True sine wave (< 5% distortion)
Output safety ground: Isolated local ground
Approvals: UL 1012, CSA C22.2 107.1 (UL 544, if desired)

Backup Power Supplies (UPS Units)


If a backup power supply (uninterruptable power supply (UPS) unit) is desired,
Beckman Coulter recommends the use of a unit incorporating local ground
isolation. Backup power supplies are designed to provide continuous AC power
to equipment after the main AC power line is lost. These units use a standby
battery with an AC inverter circuit to provide the required electrical output; some
units also provide various combinations of the protection features found in surge
suppressors and line conditioning transformers.

If a backup power supply is used, ensure that the specifications meet the
following requirements:
Minimum output capacity: 1300 VA
Output voltage: 120 or 240 VAC
Output frequency: 50 or 60 Hz, single phase
Output wave form: True sine wave (< 5% distortion)
Standby runtime: Minimum 15 minutes at 1000 watts output (low
battery indicator and/or shutdown recommended)
Approvals: UL 1778, CSA C22.2 107.1 (UL 544, if desired)

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Access Reference Manual Rev 101740M 2-5
Performance Characteristics

2.2
Performance Characteristics
This section describes the performance characteristics of the following:
• System Operation
• Temperature Sensor
• Luminometer
• Capacities
• Reaction Vessels
• System Computer
• Peripherals
• External Bar Code Wand
• External Bar Code Scanner
• Original Internal Bar Code Reader
• Wide Scan Internal Bar Code Reader

System • Warm up Cold Start: 1 hour maximum from 18°C


Operation (ambient temperature) to READY mode.
Warm Start (rebooting using the reset button
when the instrument is at a controlled
temperature): 30 minutes maximum from
18°C to READY mode.
• Random access The instrument can perform any assay, using up
to 24 on-board reagent packs, on any sample,
depending on available sample volume.
• Continuous access The operator can enter new test requests
while other samples are in process.
• Stat access The instrument allows stat samples to be
added and prioritized at any time during
routine operation.

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Performance Characteristics

• Processing speed The system throughput depends on


individual assay protocols and the mix of
assays in any run. Maximum throughput is:
• 100 test results per hour for one-step assays
• 50 test results per hour for two-step assays

Temperature • Incubator sensor 36.4315•C – 0.3•C


Sensor • Substrate (when 36.4315•C – 0.2•C
dispensed)
• Substrate incubation zone 36.4315•C – 0.2•C
of wash/read carousel
• Reagent carousel 1•C to 5•C (The air and reagent temperature is
refrigeration unit maintained at 3•C to 10•C when the
refrigeration unit reads 1•C to 5•C.)
• On-board samples Ambient temperature – 4•C

Luminometer • Read precision within a single reaction vessel is ˆ 0.2% CV.


• Drift is ˆ 0.5% in 4 weeks.

Capacities The supply status icons displayed on every screen indicate when supplies are
needed. Normally the background of these icons is gray. If the background is red,
current test processing will continue, but no new tests will be initiated.
(Exception: If a reagent supply is needed, and tests are requested that use a
different reagent supply, those tests will be initiated.)

• Assay parameters The system stores parameters for up to 350


different assays.

• Database, sample IDs Up to 1000 Sample IDs can be stored in the


system at one time.

• Database, patient Results on up to 1000 samples or 2200 test results


samples or test (whichever comes first) can be stored in the
results patient database at one time.

• Database, quality - Control name/control lot number/Test ID:


control Up to 250 control name/control lot number/
Test ID combinations can be stored in the
quality control database at one time.

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Access Reference Manual Rev 101740L 2-7
Performance Characteristics

- Data points: Up to 600 data points


(individual results) per control name/lot
number/Test ID can be stored in the quality
control database at one time.

• Reaction vessels Up to 294 reaction vessels can be installed in the


(RVs) reaction vessel supply area. When less than 60
RVs are available, the icon background is yellow.
When no RVs are available, the icon background
is red.

• Reagent packs Up to 24 assay reagent packs can be loaded on


the reagent carousel at one time. When there are
insufficient reagents in the on-board reagent
packs to process scheduled samples, the reagent
pack icon is red.

• Reagent vials and vial Up to 23 reagent vial racks containing a total of


racks 184 reagent vials can be loaded on the reagent
carousel at one time, plus one common reagent
pack. When there are insufficient reagents in the
on-board reagent vials to process scheduled
samples, the reagent pack icon is red.

• Samples Up to 60 patient samples may be loaded onto the


sample carousel at one time.

• Substrate Up to 130 mL of substrate (600 tests) is stored in


the plastic substrate bottle. When the number of
tests that can be processed with the current
supply of substrate is 60 or fewer, the substrate
icon background is yellow. When the substrate
bottle is empty, the icon background is red.

• Wash buffer Up to 3.95 L of wash buffer (300 tests) is stored in


the plastic wash buffer bottle (1.95 L) and the
wash buffer reservoir (2 L). When the supply
level sensed indicates that the number of tests
that can be processed with the current supply of
wash buffer is approximately 75 tests or less, the
wash buffer icon background is red.

• Waste, liquid Up to 4 L of liquid waste (300 tests) can be


expelled into the liquid waste bottle. When the
supply level sensed indicates that the number of
tests that can be processed with the current
available space in the waste bottle is
approximately 75 tests or less, the liquid waste
icon background is red.

• Waste, RVs Up to 300 reaction vessels can be ejected into the


reaction vessel waste bag. When there is space in
the reaction vessel waste bag for 60 vessels or
fewer, the RV waste bag icon (represented by the
biohazard symbol) is yellow. When the bag is
full, the RV waste bag icon is red.

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2-8 Rev 101740L Access Reference Manual
Performance Characteristics

Reaction • Size Diameter = 8 mm


Vessels Height = 40 mm
• Composition Polypropylene
• Reaction Volume 0.5 mL
• Maximum Capacity 1 mL

System • Either a 80386SX 20 MHz or 80486DLC or DX4 100 MHz based


Computer microcomputer
• 8 MB RAM for revision A fluidics or 16 MB RAM for revision B fluidics
• 116 MB, 120 MB, 170 MB, 2.1 GB, 3.2 GB or 6.4 GB hard disk
• 1.44 MB, 3.5-inch floppy disk drive
• RS232 serial port
• Parallel port

Peripherals • Color, 14-inch VGA monitor


• Standard 101 key, AT style keyboard
• Hewlett Packard DeskJet printer (500, 500J, 600 or 800 series) or Epson
printer (MJ-930C series)
• External hand-held bar code scanner - refer to External Bar Code Wand
below
• External bar code scanner - refer to External Bar Code Scanner below

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Access Reference Manual Rev 101740L 2-9
Performance Characteristics

External Bar • Bar code symbologies UPC, EAN/JAN


Code Wand Interleaved 2 of 5
CODABAR
CODE 39
CODE 93
CODE 128
• Depth of field 0.065 inches (1.65 mm)
• Scanning velocity 2-50 inches/second (5-127 cm/second)
• Minimum readable 7.5 mils (0.2 mm) at high resolution
module dimensions
• Minimum Reflectivity 37.5%
Difference (MRD)
• Bar code label Label should be printed on reflective, matte finish
background substrate with a background diffuse reflectance of 70-80%.
• Bar code label ink color The ink bars should not exceed 25% reflectance at
and type the reading wavelength.

External Bar • Bar code symbologies CODE 93


Code • Bar code label Length = 2.00 inches (51 mm) maximum
Scanner dimensions (including quiet zones at ends)

Height = 0.19 inches (4.8 mm) minimum


• Minimum readable 5.00 mils (0.15 mm)
module dimensions
• Bar code label Label should be printed on reflective, matte finish
background substrate with a background diffuse reflectance of 70-80%.

Original • Bar code symbologies CODE 128, with 15 characters or less variable
Internal Bar in order of preference length
Code Reader CODE 39 (ASCII codes 0 through 127 only)
Interleaved 2 of 5, with an even number from 4
to 15 characters fixed length
CODABAR (NW-7), with 4 to 15 characters
variable length

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Performance Characteristics

• Bar code label Length = 3.00 inches (80 mm) maximum


dimensions (including quiet zones at ends)

Height = 0.39 inches (10 mm) minimum

Refer to Section 1.5, Bar Code Readers/


Scanners for an illustration of a bar code label
with the quiet zones and dimensions labeled.
• Minimum readable 7.49 mils (0.19 mm)
module dimensions
• Reflectance Light Bar: 0.45 min.
Dark Bar: 0.25 max.
• Minimum Reflectivity 20%
Difference (MRD)
• Bar code label Label should be printed on reflective, matte
background substrate finish with a background diffuse reflectance of
70-80%.
• Bar code label ink color The ink bars should not exceed 25% reflectance
and type at the reading wavelength.

Wide Scan • Bar code symbologies CODE 128, with 15 characters or less variable
Internal Bar in order of preference length
Code Reader CODE 39
Interleaved 2 of 5, with an even number from 4 to
15 characters fixed length
CODABAR (NW-7), with 4 to 15 characters
variable length
• Bar code label Length = 3.00 inches (80 mm) maximum
dimensions (including quiet zones at ends)

Height = 0.39 inches (10 mm) minimum

Refer to Section 1.5, Bar Code Readers/Scanners


for an illustration of a bar code label with the
quiet zones and dimensions labeled.
• Minimum readable 7.49 mils (0.19 mm)
module dimensions
• Reflectance Light Bar: 0.50 min.
Dark Bar: 0.10 max.

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Performance Characteristics

• Minimum Reflectivity 37.5%


Difference (MRD)
• Bar code label Label should be printed on reflective, matte finish
background substrate with a background diffuse reflectance of 70-80%.
• Bar code label ink color The ink bars should not exceed 10% reflectance at
and type the reading wavelength.

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Theory of Operation

3
Theory of Operation
• Sample Processing (Section 3.1) .................................................................. 3-2

• Reaction Vessel Transport (Section 3.2) ..................................................... 3-7

• Calibration (Section 3.3) ............................................................................. 3-10

• Quality Control (Section 3.4) ..................................................................... 3-18

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Access Reference Manual Rev 101740L 3-1
Sample Processing

3.1
Sample Processing
Continuous access is the ability to process any sample at any time. The Access
Immunoassay System allows samples and most supplies to be loaded, waste
containers to be emptied, and tests to be requested while processing samples.
When test processing is initiated, all supply levels are verified, and if necessary,
the system prompts you for additional supplies. The system evaluates the
calibration, lot, and pack expiration status and, if necessary, prompts you to
perform calibration. If the system status meets requirements, processing begins
immediately. The following sections describe the sample processing sequence.

Test Request A test request is entered for each sample using the Test Request/Progress screen.
Samples can be patient samples, controls, calibration controls, or calibrators. The
samples are placed in sample trays containing 10 sample positions each. Up to 30
trays can be defined, 6 of which can be on-board (loaded onto) the system at one
time. During processing, samples can be added to an empty position on an on-
board tray or they can be placed in an empty tray which is then loaded onto the
system.

A test request includes the following information:


• Position on the sample tray (supplied)
• Sample ID (required)
• Patient ID (optional)
• Control, calibration control, or calibrator lot number (control, calibration
control, and calibrator requests only)
• List of tests to be performed
• Reagent pack lot number (required for calibration control and calibrator
requests only)
• Priority (patient sample requests only)
• Sample type (required)

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Sample Processing

If a patient sample is manually diluted prior to testing, the pre-dilution factor can
be added to the test request. The test result will automatically be multiplied by the
dilution factor entered.

There are multiple test request entry procedures. To simplify test request entry,
options such as an automatic Sample ID assignment and batch (or group) test
selection can be activated. The procedural steps can be intermixed to tailor an
entry procedure to fit your laboratory needs. Refer to Chapter 3 of the Operator’s
Guide for detailed test request entry information.

Test After tests are requested and the sample trays are loaded onto the analyzer,
Processing pressing [F11] Run initiates sample processing. The order in which samples will
Order be processed is evaluated; this order is determined by the following criteria:

1. Sample priority:
a. Stat patient samples, then
b. Calibrators and calibration controls, then
c. Controls and routine patient samples
2. Date and time the sample tray was loaded
3. Assay priority (dependent on the assay protocol)
4. Sample position within the sample tray
All stat samples are run first, in the order that they were loaded onto the analyzer.
The calibrators and calibration controls are run next, before routine patient
samples and controls. Routine patient samples and controls are run intermixed, in
the order they were loaded onto the system. All patient samples and controls on a
tray will be run together. Within a tray, all tests of a given type will be run
together, in a specified order, to maximize throughput.

Result reports for each sample are printed when testing is complete.

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Sample Processing

Sample Testing progress for each sample can be monitored using the sample status which
Status is displayed on the Test Request/Progress screen. Table 3-1 defines each sample
status.

Sample Status Definition

NoTest Sample ID exists, but no tests are requested for the sample.

Reqstd At least one test is entered for the sample.

SpWait At least one test cannot be processed due to insufficient


supplies.

InProg All tests are scheduled.

Aspir All tests are pipetted.

*Done* At least one test was cancelled.

Done All tests are completed.

Table 3-1 Sample Status Descriptions

Test State Generally, the result reports are printed when tests are done. If you print a result
report before a test is done, the report shows the test state in the Flags column,
and N/A in the Result(s) column. Table 3-2 identifies and defines each test state.
For more information on sample results and result reports, refer to Chapter 5,
Sample Results in the Operator’s Guide.

Test State Definition

Not Begun Newly created test request.

Ordered Test can be scheduled.

No Supply The test cannot be processed due to insufficient supplies.

Scheduled Test is scheduled for processing.

In Prog. Test has been pipetted.

Cancelled Test has been cancelled and no result was calculated.

Done Test processing is complete, but the result is not yet


calculated.

Table 3-2 Test State Descriptions

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Sample Processing

Tray Status Testing progress for all samples on a tray can be monitored using the tray status
which is displayed on the Test Request/Progress screen. The tray status is
dependent on the progress (or status) of each sample on the tray. The sample
which is in the earliest stage of testing determines the tray status. For example,
nine samples on a tray are In Progress but the tenth sample is Requested; the tray
status would be Requested.

The tray status information can be used to determine when a tray can be
unloaded from the system. A tray with the Aspirated status can be unloaded
without affecting testing. If you attempt to unload a tray before the Aspirated
status, a confirmation message is displayed.

Table 3-3 identifies and defines each tray status.

Tray Status Definition

No Tests Tray is empty or has samples associated but no tests


requested.

Requested At least one test is entered for the sample.

Supply Wait At least one test requires a supply to be loaded before the test
can be processed.

In Progress All samples have been scheduled for processing.

Aspirated All samples have been pipetted. The tray can now be
removed without affecting processing.

*Done* All sample processing is complete, but at least one test was
cancelled.

Done All tests are processed.

Table 3-3 Tray Status Descriptions

Reagent Pack When the system matches the tests to reagent packs/vials, the following criteria
Usage are applied to determine which reagent pack/vial is used:
• Calibrated reagent packs/vials are used first.
• If there are multiple calibrated reagent packs/vials, the pack/vial which
was punctured first is used first.
• If there are multiple calibrated, punctured reagent packs/vials, the
reagent pack/vial which expires first is used first.
• If there are no punctured reagent packs/vials, the pack/vial which
expires first is used first. If the “unpunctured” packs/vials expiration
dates match, the pack/vial that was loaded onto the analyzer first is used
first.

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Sample Processing

Supplies All reagent supply levels are verified before the system starts sample processing
to ensure adequate resources are available for the tests requested. Each test is
matched to a reagent pack/vial until all the reagents in the pack/vial are
allocated. The total number of tests requested is compared to the number of tests
which can be processed with the on-board system supplies (i.e., wash buffer,
substrate, reaction vessels). If testing supplies are sufficient, sample processing
begins. If one of the following situations applies, the Supplies Required screen is
displayed requesting the required action:
• Testing supplies are insufficient
• Waste containers need to be emptied or replaced
• A reagent pack/vial is expired
• Calibration is expired
• There is no calibration curve

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Reaction Vessel Transport

3.2
Reaction Vessel Transport
During sample processing for one-step assays, the reaction vessels are
transported from the reaction vessel loader into position for pipetting, onto the
incubator belt, to the wash/read carousel, and back onto the incubator belt for
ejection. For some two-step assays, the reaction vessels are transported from the
wash/read carousel back to the incubator belt, then back to the pipetting position
for further pipetting. For other two-step assays, the reaction vessels are
transported unwashed from the incubator belt back to the pipetting position for
additional pipetting. After processing, the RVs are ejected into the reaction vessel
waste bag. Figure 3-4 is a flow chart of the path the reaction vessels travel. The
following section describes the path during these processes.

Sample and • After a reaction vessel cartridge is placed in the supply area, where the RVs
Reagent are pre-heated, the reaction vessel rake moves the RVs into the shuttle 1 row
Additions at a time.
• The reaction vessel shuttle moves the reaction vessels to the pipetting
position on the shuttle so samples and reagents can be pipetted into each
vessel.
• The order in which the sample and reagents are pipetted is dependent on the
assay protocol.

Incubation • The vessel is moved onto the incubator belt where it remains for the time
Stage specified by the assay protocol. The temperature is controlled to ensure
optimal assay conditions.
• At the end of the incubation period, the reaction vessel is transferred from
the incubator belt to the first of three wash positions in the wash/read
carousel, or back to the pipetting position for additional pipetting.

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Reaction Vessel Transport

Washing Each wash cycle on the Access System consists of three washes.
Stage
First wash

• Wash buffer is dispensed into the reaction vessel by the first dispense
probe.
• The paramagnetic particles in the test reaction mixture are drawn to the
side of the reaction vessel by magnets located in the wash/read carousel.
• The supernatant is aspirated out of the reaction vessel by the first aspirate
probe.

Second wash

• Wash buffer is dispensed into the reaction vessel by the second dispense
probe.
• The paramagnetic particles are resuspended in the wash buffer by the
dispensed wash buffer and by spinning.
• The paramagnetic particles in the test reaction mixture are drawn to the
side of the reaction vessel by magnets located in the wash/read carousel.
• The supernatant is aspirated out of the reaction vessel by the second
aspirate probe.

Third wash

• The second wash is repeated using the third dispense probe to dispense
the buffer and the third aspirate probe to aspirate the supernatant out of
the reaction vessel.

If further processing is required, the reaction vessel is returned to the incubator


belt and positioned for additional pipetting, incubation, and washing. If no
further processing is required, the reaction vessel is moved to the substrate
position in the wash/read carousel.

Substrate • The Lumi-Phos 530 substrate is dispensed at the substrate position into the
Addition reaction vessel through the substrate probe to initiate the chemiluminescent
reaction.

Luminometer • The reaction vessel is incubated and then is moved to the luminometer
Reading where the amount of light generated is read.
• After the luminometer reading, the reaction vessel is transferred off the
wash/read carousel onto the incubator belt and the vessel is ejected into the
reaction vessel waste bag.

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Reaction Vessel Transport

Reaction Vessel Transport

Reaction vessel positioned for


sample/reagent pipetting

Moved to incubator belt for


incubation period specified
by assay protocol

1-step and some 2-step assays


moved to wash/read carousel If required, moved back to
for wash cycle; incubator belt for further
Some 2-step assays skip this processing
step

Substrate added at wash/read


carousel where reaction
vessel remains for
incubation period

Moved into position where


luminometer reads light
generated by reaction

Moved to incubator belt and


ejected into RV waste bag

Figure 3-4 RV Transport

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Access Reference Manual Rev 101740L 3-9
Calibration

3.3
Calibration
Two types of calibration can be performed with the Access Immunoassay System:
luminometer and assay. The luminometer is calibrated automatically and requires
no operator input. The following subsection, Luminometer Calibration, describes
the theory of luminometer calibration.

Assay calibration can be quantitative, qualitative, or semi-quantitative,


depending on the assay protocol. The assay calibration can be performed when
prompted by the Access System or when desired by the operator. The following
sections describe assay calibration. Refer to Chapter 6 of the Operator’s Guide for
detailed information on assay calibrators or calibration controls.

Assay calibration data is automatically evaluated by the system using acceptance


criteria defined by the assay protocol. The calibration acceptance criteria are
automatically applied to the data and acceptance or rejection of the data occurs
without operator intervention.

Luminometer The luminometer in the Access System analyzer is calibrated against a luminous
Calibration standard when the system is manufactured. The status is periodically verified by
a technical support representative as part of the preventative maintenance
routine. An LED (light emitting diode) is used as an on-board reference standard
to maintain luminometer reading consistency. The LED is located on the wash/
read carousel, directly across from the luminometer and is automatically read at
pre-programmed intervals. A correction factor, based on the LED reading, is
calculated and applied to all raw RLU (relative light unit) measurements.

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Calibration

Assay A current (or Active) assay calibration is required for each assay that is to be
Calibration performed. The Access System provides three types of assay calibration:
• Quantitative calibration provides a multi-point calibration curve that is
used to calculate the concentration of an analyte in a patient sample or
control.
• Qualitative calibration provides a cutoff value to which patient samples
are compared and categorized as reactive or non-reactive for the analyte.
• Semi-quantitative calibration provides a multi-point calibration curve to
which patient samples are compared to calculate a concentration value
and categorized into qualitative classes for the analyte.

Calibration should be performed when:


• The Active calibration has expired
• A new reagent pack/vial lot number is used
• A major system component has been repaired or replaced
• Indicated by quality control data

Quality control samples should be run after scheduled or unscheduled


maintenance to verify calibration.

Calibrators and calibration controls are packaged in sets appropriate for the assay.
The number of calibrators or calibration controls required is defined by the assay
protocol. Specific information is provided on a calibration card included with
each calibrator set. This data can be entered into the system configuration using
the keyboard or the external bar code wand.

Refer to Chapter 3 and Chapter 6 of the Operator’s Guide for detailed information
on processing calibrators and calibration controls.

Quantitative Quantitative assay calibration is the process by which a set of samples with
Assay known analyte concentrations (i.e., assay calibrators) is tested like patient samples
Calibration to measure the response. A mathematical relationship between the measured
response and the analyte concentration is then derived. This mathematical
relationship is called a “calibration curve.” A calibration curve is used to convert
raw measurements in RLU (relative light unit) to specific analyte concentrations.

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Calibration

The shape of the curve is determined by the mathematical model used. The math
model is defined in the assay protocol. The quantitative calibration math models
used are the following:
• Weighted four parameter logistic (4PLC)
• Weighted smoothing spline
• Straight line

The calibration data and associated curve can be displayed and/or printed using
the Calibration Data and Calibration Curve screens. Refer to Chapter 6 of the
Operator’s Guide for detailed instructions.

Semi- Semi-quantitative assay calibration is very similar to quantitative assay


Quantitative calibration, except that the final result is reported as an interpretation, or class, in
Assay addition to a specific value. A set of samples with known analyte concentrations
Calibration (i.e., assay calibrators) is tested like patient samples to measure the response, then
a mathematical relationship between the measured response and the analyte
concentration is derived. This mathematical relationship is called a “calibration
curve,” which is then used to convert raw RLU measurements to specific analyte
concentrations. The analyte concentrations are compared to a set of
interpretations or classes defined by the assay protocol, such as Negative,
Equivocal, Reactive, Non-Reactive, Positive, Class <1, Class 1, or Class 2.

Calibration reports for semi-quantitative assays contain the specific analyte


concentration, but generally do not list the interpretation. Screens and reports for
quality control and patient samples list both the concentration and the
interpretation.

The calibration data and associated curve can be displayed and/or printed using
the Calibration Data and Calibration Curve screens. Refer to Chapter 6 of the
Operator’s Guide for detailed instructions.

Qualitative A qualitative assay classifies patient samples as either reactive or non-reactive


Assay based on a comparison of the patient result to calibration controls of known
Calibration reactivity or a calculated cutoff value. Reactive and non-reactive calibration
controls are the basis of qualitative assay calibration.

The procedures for defining calibration controls in the system configuration and
requesting them for processing are virtually identical to the procedures for
defining and requesting calibrators. Therefore, calibrators and calibration controls

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Calibration

are entered into system configuration using the same screen (refer to Chapter 7,
System Configuration).

Confirmatory Some qualitative assays have an associated confirmatory assay which can be used
Assays to confirm reactive patient sample results. The percent (%) suppression of RLUs
for the confirmatory assay is calculated to determine if a reactive result is
confirmed or not confirmed.

If both the screening and confirmatory test are selected in a test request, a
confirmatory result will be automatically reported for reactive samples. When
requested, the confirmatory test is linked with the most recently completed
screening result for that patient sample. There are three scenarios for requesting
and processing screening and confirmatory assays.

Tests run separately: In this situation, the screening assay is processed first.
After reviewing the result, the confirmatory test is
requested. The confirmatory result is calculated using
the previously completed screening test data. The
confirmatory test can be requested ONLY if the
patient sample has not been removed from the
analyzer.
Tests run together: The screening and confirmatory tests are requested at
the same time. The confirmatory result is calculated
using the screening test data processed at the same
time. In this situation, the confirmatory test will be run
on all samples, regardless of the screening test results.
Screening test repeated: The screening test is requested and processed. After
reviewing the results, the confirmatory test, and
another screening test is requested. The confirmatory
result is calculated using the second screening result.

The percent suppression calculation is:


[(A-B) /A] *100 (assays with a positive slope - or direct RLU to analyte
relationship)

where:
A = Patient sample RLUs obtained in the screening assay
B = Patient sample RLUs obtained in the confirmatory assay (Each
confirmatory assay replicate is evaluated separately)

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Calibration

If the percent suppression is greater than or equal to the pre-set limit defined by
the assay protocol, the result is Confirmed. If the percent suppression is less than
the pre-set limit, the result is Not Conf (Not Confirmed).

The replicate(s) used to calculate the confirmatory result are listed in the
Comments field on the result report.

Refer to the product insert for assay specific information.

Stored For quantitative and semi-quantitative assays, up to three sets of calibration data
Quantitative are stored for each calibrator set/reagent pack/vial lot number or calibration
and Semi- control set/reagent pack/vial lot number combination. The following is a
Quantitative description of the stored calibration data:
Calibration Last Run Last Run calibration data to which acceptance criteria were
Data applied. If the Last Run calibration is accepted, it becomes the
Active calibration and the Last Run and Active calibrations are
the same calibration data.
Active The most recently accepted calibration. If the Last Run calibration
is rejected, the current Active calibration remains in use.
Previous When a new calibration is accepted, the old Active calibration
becomes the Previous calibration.
Only the Active calibration is used to evaluate patient samples.

NOTE
A calibration remains active until it is replaced by a new, accepted calibration. An
active calibration may expire, as defined by the assay protocol, but it would still
be used to evaluate patient samples until it is replaced.

Stored For qualitative assays, two sets of calibration data may be stored for each
Qualitative calibrator set/reagent pack/vial lot number or calibration control set/reagent
Calibration pack/vial lot number combination. The following is a description of the stored
Data calibration data:

Last Run Last Run calibration data to which acceptance criteria were
applied. If the Last Run calibration is accepted, it becomes the
Active calibration and the Last Run and Active calibrations are
the same calibrations.
Active The most recently accepted calibration. If the Last Run
calibration is rejected, no Active calibration exits. Calibration
must be repeated.

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Calibration

Only the Active calibration is used to evaluate patient samples.

NOTE
A calibration remains active until it is replaced by a new, accepted calibration. An
active calibration may expire, as defined by the assay protocol, but it would still
be used to evaluate patient samples until it is replaced.

Acceptance The four parameter logistic curve (4PLC), smoothing spline, and straight line
Criteria for math models are used to fit calibration data to a curve.
Quantitative
Weighting constants are used in curve fitting, and are defined by each assay
and Semi-
protocol. Weighting is required because the precision of the assay varies with the
Quantitative analyte concentration. Weighting constants are derived from pooled signal RLU
Assay variance data.
Calibration
For some quantitative and semi-quantitative assays, the assay protocol defines
acceptable limits for the % CV obtained from the replicates of the S0 (or zero)
calibrator. If the % CV obtained is outside these limits, the calibration is rejected.

The acceptance method used by the Access System is called the “precision
profile” method. This method can be used with any fitted curve math model for
which summed squares of the residuals are calculated. The precision profile
method consists of three steps:
• Fitting calibration data using the defined math model for that assay.
• Calculation of predicted precision at various analyte concentrations.
• Comparison of predicted precisions and the defined limits for that assay.

When fitting the calibration data to the math model, the calculation process tries
to minimize the distance of the individual data points from the calculated curve
(residuals). The individual replicates, not the mean, are used to calculate the
curve. The calculations are repeated (iterated) until the “best curve” (i.e., the
curve for which the residuals are the least) is obtained. If the maximum number of
iterations is performed without calculating an acceptable curve, the calibration is
rejected. The system may delete one replicate due to a fatal error in processing the
calibrator. However, if more than one replicate was flagged with a fatal error, the
calibration will automatically be rejected.

After an acceptable curve is obtained, an error band is calculated around the curve
based on the distance of the calibration data points from the curve (Figure 3-5).
The calibration data and the shape of the math model to which the calibration data
are fitted are used to predict the precision at various analyte concentrations. At
analyte concentrations defined by each assay protocol, a predicted precision is

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Calibration

calculated and compared to defined limits. If the result for any analyte
concentration is outside the acceptable limits (i.e., outside the error band), the
calibration is rejected.

Error Band

RLU

Precision

Analyte Concentration

Note: The width of the error band is exaggerated for illustration purposes.

Figure 3-5 Graphical Representation of Error Bands

Acceptance The assay protocol defines the limits for each calibration control used to calculate
Criteria for the cutoff value for qualitative assays. Refer to the product insert for the equation
Qualitative used to calculate the cutoff value. The RLU limits for a calibration control are
Assay applied to the following:
Calibration • Each replicate of the reactive calibration control
• Each replicate of the non-reactive calibration control
• Mean of the reactive calibration control replicates
• Mean of the non-reactive calibration control replicates

The assay protocol determines the number of replicates that must be within the
acceptable RLU limits for the assay calibration to be accepted. Two or more
replicates of each calibration control must be within the acceptable limits because
each mean must be calculated using at least 2 replicates. If the mean cannot be
calculated or the calculated mean fails to meet the criteria specified by the assay
protocol, the calibration is rejected.

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Calibration

For some qualitative assays, the assay protocol defines acceptable limits for the
% CV of the RLUs obtained for the replicates of each calibration control. If the
% CV obtained is outside these limits, the assay calibration is rejected.

Reasons for If a calibration is rejected, the reason for rejection is displayed on the Last Run
Calibration Calibration Data screen in the Status field. Table 3-6 outlines the reasons
Rejection calibrations can be rejected.

Bad Fit The calibration data does not meet the limits defined
by the assay protocol.

CV Std 0 The % CV of the replicates for the zero calibrator does


not meet the limits defined by the assay protocol.

Insuff Data There was not enough data to perform the calibration
calculations. This occurs if two or more replicates were
not calculated due to an instrument error.

Limits The RLUs obtained for 1 or more of the calibration


controls were outside the acceptable limits defined by
the assay protocol.

Max Iter The maximum number of calculation iterations was


reached before the curve fitting routine was able to
find a “best fit.”

No Fit The curve fitting routine was unable to calculate curve


parameters. Possible causes include math rule
violations such a division by zero or log of a negative.

Resp. Delta The difference between the lowest and highest


calibration responses is outside of the limits for the
calculated Response Delta number.

Table 3-6 Reasons for Calibration Rejection

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Quality Control

3.4
Quality Control
Quality control samples are tested to ensure the validity of the patient sample
results generated. Control samples should be processed as recommended in the
product insert. To best simulate the characteristics of the patient samples, the
control samples used are prepared from materials similar to the patient sample
being tested. For example, if testing serum, the quality control samples used
should also be serum based. In addition, multiple quality control samples can be
included to cover the entire measuring range of the test method.

Each laboratory should establish the acceptable range for commercially available
quality control materials. The manufacturer’s suggested ranges may be used until
an adequate number of samples have been processed to determine a lot-specific
mean and standard deviation.

The Access Immunoassay System monitors the performance of each defined


control. To process a quality control sample, detailed information is entered in
system configuration, a test request is entered, and then the control is loaded onto
the system. The system can be configured to use all or any combination of the five
following QC rules to aid in monitoring assay performance:
• 12s (1-2s) - Flag when one point is more than 2 SD from the mean.
• 22s (2-2s) - Flag when 2 consecutive points are more than 2 SD from the
mean in the same direction. Only the second point is flagged.
• 13s (1-3s) - Flag when one point is more than 3 SD from the mean.
• 41s (4-1s) - Flag when 4 consecutive points are more than 1 SD from the
mean in the same direction. Only the fourth point is flagged.
• 10x (10x) - Flag when 10 consecutive points are on the same side of the
mean (for example, 10 points are above the mean). Only the
tenth point is flagged.

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Quality Control

The QC rules are dependent on the range of results being viewed in the QC Data
or Levey-Jennings Chart screens. Therefore, if a result fails to meet QC rule
criteria when viewed in one set of results, it may not fail to meet that rule when
viewed in a different set of results. In addition, a result can be omitted from
quality control calculations using the QC Data screen, and is therefore not used in
QC rule calculations. When a quality control result fails to meet an activated QC
rule, the quality control icon background is red until the control results are
reviewed.

Refer to Chapter 3 and Chapter 7 of the Operator’s Guide for detailed information
on processing controls.

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 3-19
Quality Control

3/00 © 2000 Copyright Beckman Coulter, Inc.


3-20 Rev 101740L Access Reference Manual
System Diagnostics

4
System Diagnostics
• Introduction (Section 4.1)............................................................................. 4-2

• Event Log (Section 4.2) ................................................................................. 4-3

• Diagnostics Screen (Section 4.3) .................................................................. 4-5

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 4-1
Introduction

4.1
Introduction
The Access Immunoassay System is designed to help “diagnose” an instrument
problem should one occur. If a system problem is encountered, an entry is made
in the Event Log (Figure 4-1). The information in the Event Log (Table 4-2) assists
in determining when and where the problem occurred.

The Diagnostics screen (Figure 4-3) is accessed by pressing [F7] Diag. from the
Main Menu and can be used to further troubleshoot the problem.

NOTE
Diagnostics cannot be accessed when the analyzer is in the RUNNING mode.

3/00 © 2000 Copyright Beckman Coulter, Inc.


4-2 Rev 101740L Access Reference Manual
Event Log

4.2
Event Log
The Access System monitors the status of various system parameters. The Event
Log (Figure 4-1), accessed by pressing the [Scroll Lock] key from any screen,
displays messages and codes to assist with troubleshooting. When a warning
message is entered into the Event Log, the background of the Event Log icon is
displayed in yellow or red, depending on the type of event. Informational
messages (e.g., Special Clean procedure completed) are also entered into the
Event Log, but the background of the Event Log icon remains gray. To print all of
the messages in the Event Log, press the [F7] Print Event Log key.

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 4-3
Event Log

Event Log
0

System initialized
1996/ 6/14 12:58:10 360002 uiaccess(011) [ 81]
RV pack loaded
1996/ 6/14 12:51:24 7c0010 uiaccess(011) [ 81]
System initialized
1996/ 6/14 12:43:33 360002 uiaccess(011) [ 81]
SHUT error occurred before cleanout
1996/ 6/14 12:40:39 360501 uiaccess(011) [ 81]
RAKE Init Command Err <4 1 1 1000 11 32501 32510>
1996/ 6/14 12:39:25 370403 rake (021) [ 81]
System initialized
1996/ 6/14 12:32:08 360002 uiaccess(011) [ 81]

Print
Event Log

F1 F2 F3 F4 F5 F6 F7 F8

Figure 4-1 Event Log

Event Log Each Event Log entry is comprised of two lines of text. The first line contains the
Messages command message and, if appropriate, numbers that describe the error, such as the
minimum, maximum, and actual values. The second line consists of the date, time,
event code, device controller, and the sequence number.

For example, if the substrate temperature is outside the acceptable limits, an entry
is made in the Event Log detailing the system condition. In addition, the
corresponding test result is labeled with a flag to alert you that the result is suspect.

If a sample result is flagged with a system error (SYS), the time at which the error
occurred is displayed in the Test Request/Progress and View Test Results screens
and is printed on the result report. This time can then be matched to the
appropriate Event Log entry to determine the system error that caused the flag.

[F7] Print Event Prints all of the messages in the Event Log.
Log

Table 4-2 Event Log Screen Fields and Functions

3/00 © 2000 Copyright Beckman Coulter, Inc.


4-4 Rev 101740L Access Reference Manual
Diagnostics Screen

4.3
Diagnostics Screen
Various system parameters are monitored by the system and can be viewed using
the Diagnostics screen (Figure 4-3 and Table 4-4), which is displayed when you
press [F7] Diag. from the Main Menu.

The [F1] System Init. option initializes (homes) the system.

The [F6] Temp./Voltage/Vacuum and [F7] Print Align. Report keys access
functions you can use to help determine the nature of a system failure or review
the current status of the system.

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 4-5
Diagnostics Screen

Diagnostics
1

System Mechanics Lumin- Ultra- Digital Temp. Print More


Init ometer sonics Devices Voltage Align. Options
Vacuum Report
F1 F2 F3 F4 F5 F6 F7 F8

Figure 4-3 Diagnostics Screen

[F1] System Opens the System Initialization screen and initializes the primary system
Initialization devices. The devices are returned to the start or “home” positions.

[F2] Mechanics Opens the Mechanics screen which allows alignment of specific mechanical
devices on the analyzer. DO NOT use this screen unless so directed by a
technical support representative or if you are following instructions in this
manual or in the Operator’s Guide.

[F3] Luminometer Opens the Luminometer screen which allows verification of the luminometer
calibration. DO NOT use this screen unless so directed by a technical
support representative. If the luminometer calibration is inadvertently
altered, call Technical Support immediately.

[F4] Ultrasonics Opens the Ultrasonics screen which allows alteration and/or verification of
the ultrasonic transducer status. DO NOT use this screen unless so directed
by a technical support representative.

Table 4-4 Diagnostics Screen Fields and Functions

3/00 © 2000 Copyright Beckman Coulter, Inc.


4-6 Rev 101740L Access Reference Manual
Diagnostics Screen

[F5] Digital Devices Opens the Digital Devices screen which allows you to turn off/on certain
digital devices (various pumps, valves, motors and sensors) on the analyzer.
Also provides the status (open/closed) of certain access doors on the
analyzer. DO NOT use this screen unless so directed by a technical support
representative.

[F6] Temp. Voltage Opens the Temperature/Voltage Status screen which provides the current
Vacuum temperature of various areas of the analyzer, voltage of the power supply,
and pressure in the vacuum bottle.

[F7] Print Alignment Prints the run-hour status and the current alignment information for various
Report mechanical devices. The run-hour status is a measure of the time the analyzer
has spent processing samples.

[F8] More Options Opens a menu of options including LIS, Expanded Archive Data, Archive
Service Data, Exerciser, Calib. Incubator Belt, and Print Belt Cal. Report.

The LIS option opens the LIS Diagnostics screen (refer to Appendix A, LIS
Interface). The Expanded Archive Data and Archive Service Data options
save test and system data to disk (refer to Section 6.5, Archiving Data To
Disk). The Exerciser option cycles movement of various mechanical devices
on the analyzer. Selecting the Exerciser option starts the pre-programmed
exercise routine. The Calib. Incubator Belt option re-calibrates the incubator
belt after maintenance, and the Print Belt Cal. Report option prints a report
containing incubator belt calibration data.

DO NOT use either the Exerciser or the Calib. Incubator Belt function
unless so directed by a technical support representative or if you are
following instructions in this manual or in the Operator’s Guide.

Table 4-4 Diagnostics Screen Fields and Functions (continued)

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 4-7
Diagnostics Screen

System 1 Press [F7] Diag. from the Main Menu.


Initialization
The Diagnostics screen is displayed.

2 Press [F1] System Init.

A confirmation message is displayed.

3 Ensure Y is highlighted, then press [Enter].

All primary system devices are initialized and “homed”.

Mechanics
CAUTION
DO NOT use this function unless directed to do so by a technical support
representative or if you are following instructions in this manual or in the
Operator’s Guide.

1 Press [F7] Diag. from the Main Menu.

The Diagnostics screen is displayed.

2 Press [F2] Mechanics.

The Mechanics screen is displayed. The alignment values can be reviewed.

Luminometer
CAUTION
DO NOT use this function unless directed to do so by a technical support
representative.

1 Press [F7] Diag. from the Main Menu.

The Diagnostics screen is displayed.

2 Press [F3] Luminometer.

The Luminometer screen is displayed. The luminometer calibration values


can be reviewed.

3/00 © 2000 Copyright Beckman Coulter, Inc.


4-8 Rev 101740L Access Reference Manual
Diagnostics Screen

Ultrasonics
CAUTION
DO NOT use this function unless directed to do so by a technical support
representative.

1 Press [F7] Diag. from the Main Menu.

The Diagnostics screen is displayed.

2 Press [F4] Ultrasonics.

The Ultrasonics screen is displayed. The primary probe parameters can be


reviewed.

Digital CAUTION
Devices
DO NOT use this function unless directed to do so by a technical support
representative.

1 Press [F7] Diag. from the Main Menu.

The Diagnostics screen is displayed.

2 Press [F5] Digital Devices.

The Digital Devices screen is displayed. The status of various digital devices
can be reviewed.

Temperature/ 1 From the Main Menu press [F7] Diag.


Voltage/
The Diagnostics screen is displayed.
Vacuum
2 Press [F6] Temp./Voltage/Vacuum.

The Temperature/Voltage Status screen is displayed. The temperature of


various system zones and voltage of the power supply are displayed.

3 Press [F1] Raw Voltage Data to display voltages.

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 4-9
Diagnostics Screen

Print 1 From the Main Menu press [F7] Diag.


Alignment
The Diagnostics screen is displayed.
Report
2 Press [F7] Print Align. Report.

A report of the run-hour status and all of the alignment values for all
primary system devices is printed (refer to Figure 4-5 for an example of the
report).

Exerciser
CAUTION
DO NOT use this function unless directed to do so by a technical support
representative or if you are following instructions in this manual or in the
Operator’s Guide.

1 Press [F7] Diag. from the Main Menu.

The Diagnostics screen is displayed.

2 Press [F8] More Options.

A menu of options is displayed.

3 Use the [Arrow] keys to move the cursor to Exerciser, then press [Enter].

4 Press [F1] Select Exerciser Test.

A menu of options is displayed.

5 Use the [Arrow] keys to highlight the appropriate exerciser test, then press
[Enter] to select.

6 Press [F2] Start Cycling.

The system immediately begins the corresponding exercise routine used by


technical support representatives to ensure the system is functioning
properly.

7 Press [F8] Stop Cycling.

NOTES
• The [F8] Stop Cycling key is displayed after [F2] Start Cycling is pressed.
• Pressing [F8] Stop Cycling does not immediately stop the exercise routine.
The test will stop after the present cycle is completed.

3/00 © 2000 Copyright Beckman Coulter, Inc.


4-10 Rev 101740L Access Reference Manual
Diagnostics Screen

Laboratories, Inc.
Laboratory A
123 Lake Street
Townsville, ST 33333
Director
System ID
Technologist
Other Text

Alignment Report

Total run time: 14.11 hours

Mean LED counts: 724330.6


PMT H.V.Control: 3.7588

Device: Pipettor

Reagent - X 7
Sample - X 8
Wash - X 6
RV - X 11
Reagent - Z -37
Sample - Z -14
Wash - Z -6
RV - Z 1

Device: Sample Carousel

Load/Unload -1
Tube Detector 0
Bar Code Reader -5
Aspirate -6

Device: Reagent Carousel

Load/Unload 0
Aspirate -5

Device: Incubator Belt

Shuttle Xfer -10


Wash In -2
Wash Out 2
Neph Pipettor 0

Device: RV Shuttle

CW Align 30
CCW Align 25

Device: Rake

RV Inc -19

Device: Wash Arm

Page 1 of 3
Technologist _______ 03-25-99 2:24 pm

Figure 4-5 Example Alignment Report

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 4-11
Diagnostics Screen

Laboratories, Inc.
Laboratory A
System ID

Alignment Report

Wash Crsl/Arm -7

Device: Wash Carousel

Wash Out Align -4


CW Align 0
CCW Align 1

Device: Waste Valve

CW Align -1
CCW Align 0

Device: Wash Valve

CW Align 1
CCW Align 1

Device: Precision Valve

CCW Align -6

Device: Wash Pump

Backlash Cal. 0

Device: Neph Pipettor

Incubator 0

Model Number R81600


Serial Number 400075
System Software 3.25
Assay Descriptor File 1.2007
Process Protocol File 1.2005
Vial/Pack Descriptor File 1.2008
Calibration Protocol File 1.2006
Calibrator Set File 1.2006
Operating System 1.27
DSMC PCB
DSMC Firmware 65
CPU BIOS
Stepper Driver PCB 35
Power Driver PCB 33
Ultrasonic PCB 33
Backplane PCB 34
I/O PCB 33
RV Shuttle 2
Dispense Probes

Page 2 of 3 03-25-99 2:24 pm

Figure 4-5 Example Alignment Report (continued)

3/00 © 2000 Copyright Beckman Coulter, Inc.


4-12 Rev 101740L Access Reference Manual
Diagnostics Screen

Laboratories, Inc.
Laboratory A
System ID

Alignment Report

Wash Carousel Drive 2


Nephelometer Not Installed
External Bar Code Reader
Internal Bar Code Reader Wide Scan
Mixer Speed 2
Spare 0

Calibrator Reference for assay TU = 40


Dilution Factor for assay Dil-hCG2 = 200

Page 3 of 3 03-25-99 2:24 pm

Figure 4-5 Example Alignment Report (continued)

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 4-13
Diagnostics Screen

Calibrate
Incubator Belt CAUTION
DO NOT use this function unless directed to do so by a technical support
representative or if you are following instructions in this manual or in the
Operator’s Guide.

1 Press [F7] Diag. from the Main Menu.

The Diagnostics screen is displayed.

2 Press [F8] More Options.

A menu of options is displayed.

3 Use the [Arrow] keys to move the cursor to Calib. Incubator Belt,
then press [Enter].

The system immediately begins a calibration routine on the incubator belt


that is used by technical support representatives after servicing the
incubator belt.

Print Belt 1 Press [F7] Diag. from the Main Menu.


Calibration
The Diagnostics screen is displayed.
Report
2 Press [F8] More Options.

A menu of options is displayed.

3 Use the [Arrow] keys to move the cursor to Print Belt Cal. Report, then
press [Enter].

A report containing incubator belt calibration data is printed (refer to Figure


4-6 for an example of the report). Print this report after running the incubator
belt calibration procedure.

3/00 © 2000 Copyright Beckman Coulter, Inc.


4-14 Rev 101740L Access Reference Manual
Diagnostics Screen

ACCESS IMMUNOASSAY SYSTEM

Laboratories, Inc.
Laboratory A
123 Lake Street
Townsville, ST 33333

Incubator Belt Calibration Report

Clip CW Nom CCW Nom Clip CW Nom CCW Nom


Number Value Diff Value Diff Number Value Diff Value Diff
0 7186 0 7220 6 1 6987 1 7015 1
2 6788 2 6815 1 3 6588 2 6616 2
4 6388 2 6415 1 5 6188 2 6216 2
6 5988 2 6015 1 7 5787 1 5815 1
8 5587 1 5615 1 9 5388 2 5415 1
10 5187 1 5215 1 11 4688 1 5015 1
12 4787 1 4816 2 13 4588 2 4616 2
14 4388 2 4416 2 15 4188 2 4215 1
16 3987 1 4015 1 17 3788 2 3815 1
18 3588 2 3615 1 21 2687 1 3416 2
20 3187 1 3215 1 21 2987 1 3015 1
22 2788 2 2816 2 23 2588 1 2616 2
24 2387 1 2415 1 25 2187 1 2215 1
26 1987 1 2015 1 27 1788 2 1815 1
28 1586 0 1615 1 29 1387 1 1415 1
30 1187 1 1216 2 31 988 2 1015 1
32 786 0 814 0 33 587 1 615 1
34 387 1 415 1 35 187 1 215 1
36 11986 0 15 1 37 11788 2 11815 1
38 11588 2 11616 2 39 11388 2 11416 2
40 11186 0 11214 0 41 10987 1 11015 1
42 10786 0 10815 1 43 10588 2 10615 1
44 10386 0 10414 0 45 10187 1 10215 1
46 9987 1 10015 1 47 9786 0 9815 1
48 9587 1 9615 1 49 9386 0 9415 1
50 9186 0 9215 1 51 8986 0 9014 0
52 8786 0 8815 1 53 8587 1 8615 1
54 8387 1 8415 1 55 8187 1 8215 1
56 7987 1 8016 2 57 7788 2 7815 1
58 7588 2 7615 1 59 7388 2 7415 1

Last Incubator Belt Calibration Date: 05-01-97

Page 1 of 1 Technologist Printed: 05-01-97 2:24 pm

Figure 4-6 Example Incubator Belt Calibration Report

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 4-15
Diagnostics Screen

3/00 © 2000 Copyright Beckman Coulter, Inc.


4-16 Rev 101740L Access Reference Manual
Troubleshooting

5
Troubleshooting
• Introduction (Section 5.1)............................................................................. 5-2

• System Check Troubleshooting (Section 5.2) ............................................ 5-3

- Substrate Check Problems .................................................................... 5-4

- Unwashed Check Problems ................................................................. 5-7

- Washed Check Problems .................................................................... 5-10

- System Check Problems—Wash Efficiency ..................................... 5-14

• Instrument Troubleshooting (Section 5.3) ............................................... 5-15

- General Instrument Troubleshooting ............................................... 5-16

- Start-Up Problems................................................................................ 5-19

- Power Problems ................................................................................... 5-19

- Keyboard Problems ............................................................................. 5-20

- Bar Code Reading Problems............................................................... 5-21

- Air in System ........................................................................................ 5-22

- Main Pipettor Problems ...................................................................... 5-23

• Assay Troubleshooting (Section 5.4) ........................................................ 5-24

- Calibration Problems........................................................................... 5-25

- Quality Control Problems................................................................... 5-27

- Patient Sample Problems .................................................................... 5-29

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 5-1
Introduction

5.1
Introduction
This chapter includes troubleshooting procedures for identifying and correcting
problems that might occur during system operation. There are two general types
of system failure:
• Instrument failure
• Assay failure

The following sections describe symptoms, possible causes, and corrective actions
for each of these types of system failure.

The Event Log displays messages and codes which can guide you and/or a
technical support representative during troubleshooting. Various system
parameters are monitored by the system and can be viewed using the Diagnostics
screen. Refer to Chapter 4, System Diagnostics.

Result reports may include fatal or non-fatal flags that can also assist you in
troubleshooting. For information about flags, refer to the Operator’s Guide,
Chapter 5, Sample Results.

3/00 © 2000 Copyright Beckman Coulter, Inc.


5-2 Rev 101740L Access Reference Manual
System Check Troubleshooting

5.2
System Check Troubleshooting
System Check results that are out of range of expected values may indicate
operational problems with the instrument. To review System Check expected
values, refer to Table 8-11 in the Operator’s Guide. To review information about
how the System Check works, refer to Section 6.7, System Check Support
Information.

Use the troubleshooting tables in this section to assist you in troubleshooting out-
of-range System Check results. The troubleshooting tables identify symptoms, list
possible causes for the symptoms, and provide the corrective action for each
cause, sorted by the result that is out of range. If you have out-of-range results for
more than one area of the System Check, troubleshoot the problem in the
following order:
• Substrate Check Problems
• Unwashed Check Problems
• Washed Check Problems
• Wash Efficiency Problems

When you have corrected a problem, perform another System Check to confirm
the results and/or further identify the problem. You are done troubleshooting
when you complete the System Check with all results within expected ranges.

Because you troubleshoot problems in sequence, problems in the tables for each
subsequent area of the System Check are limited to problems not ruled out by the
previous area of the System Check.

If you are unable to identify the cause of a problem or if the problem persists after
performing the specified troubleshooting procedure(s), call Technical Support for
assistance.

© 2001 Copyright Beckman Coulter, Inc. 4/01


Access Reference Manual Rev 101740P 5-3
System Check Troubleshooting

Substrate If the System Check fails the first time, it should be repeated to rule out
Check procedural problems. Use a new aliquot of undiluted System Check Solution and
Problems a new 1/501 dilution.

If System Check results do not fall within expected ranges, troubleshoot the
Substrate Check problems first. The Substrate Check uses the fewest system
components. When the Substrate Check results from the complete System Check
are within range, the substrate and substrate system generally can be ruled out as
causes for subsequent out-of range results.

NOTE
After troubleshooting, the complete System Check procedure must be run again
to confirm the success of your efforts. If a Substrate Check is run independently,
it will not indicate problems due to plugged or dirty probes.

System Check Problems—Substrate Check


Symptom Possible Causes Corrective Action

High substrate Aspirate probes are dirty or Clean the aspirate probes. Refer to the
ratio plugged, causing fluid to adhere Replacing and Cleaning Aspirate Probes
and drip. heading of Section 8.4, Weekly Maintenance
of the Operator’s Guide for instructions.

Revision A fluidics: Visually inspect the 6 fluid fittings on the


Fluid dripping from aspirate waste valve for leakage. If leak found, call
probes due to loose fittings on Technical Support for assistance.
waste valve.

Revision B fluidics: Inspect the tubing, and the area under the
Fluid dripping from aspirate tubing, from the peristaltic waste pump to
probes due to damaged peristaltic the aspirate probes for crystalline deposits.
waste pump tubing. Deposits may indicate that the tubing is
damaged and should be replaced. Call
Technical Support for assistance. Refer to
the Chapter 6 tubing replacement procedure
only when instructed by Technical Support.

Fluid dripping from aspirate Call Technical Support.


probes due to plugged waste air
filter.

High % CV due to The System Check is not diluted or Use a new aliquot of undiluted System
high values in improperly diluted, or the cups are Check Solution and prepare a new 1/501
only the last one out of order in the maintenance dilution. Run the System Check again. Refer
or two replicates. tray. to Section 8.4, Weekly Maintenance of the
Operator’s Guide to review the correct
System Check procedure.

10/01 © 2001 Beckman Coulter, Inc.


5-4 Rev 101740R Access Reference Manual
System Check Troubleshooting

System Check Problems—Substrate Check (continued)


Symptom Possible Causes Corrective Action

High % CV with Inconsistent substrate delivery Check the substrate supply bottle and
random due to insufficient supply. replenish, if necessary, using the Supplies or
variability Supplies Required screen. Refer to Section
throughout 2.6, Substrate of the Operator’s Guide for
replicates. more information.

Inconsistent substrate delivery Lift the front panel and inspect the substrate
due to air in fluid lines. tubing. You can expect to see air bubbles.
Close the front panel and prime the
substrate by pressing [F6] Maint. from the
Main Menu, [F4] Fluidics Priming, then
[F3] Substrate. After priming, inspect the
tubing again. You should see no bubbles in
the tubing. If you see bubbles, continue
troubleshooting.

Inconsistent substrate delivery Revision A fluidics:


due to leak in substrate system. Visually inspect the fluid fittings on the
substrate pump (1 fitting), valve (3 fittings),
and heater (1 fitting) for deposits (refer to
Chapter 1 for part locations). Call Technical
Support for further instructions.

Revision B fluidics:
Visually inspect tubing to and from the
substrate pump/heater assembly, fluid
fittings on the substrate pump (2 fittings),
and valve to pump connections for deposits
(refer to Chapter 1 for part locations).
Deposits may indicate damaged tubing
which should be replaced. Call Technical
Support for further instructions.

Inconsistent substrate delivery Visually inspect tubing for kinks to and


due to kinked tubing. from the substrate pump/ heater assembly
(refer to Chapter 1 for part locations).
Straighten kinked tubing if found. Then,
prime the substrate system by pressing
[F6] Maint. from the Main Menu,
[F4] Fluidics Priming, then [F3] Substrate.

Inconsistent substrate delivery or Inspect the substrate probe (left most probe
splashing due to bent substrate on the wash arm - refer to Section 8.3 of the
probe. Operator’s Guide for probe location). If probe
is bent, call Technical Support for further
instruction.

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 5-5
System Check Troubleshooting

System Check Problems—Substrate Check (continued)


Symptom Possible Causes Corrective Action

High % CV with Poor substrate delivery precision Call Technical Support.


random due to substrate pump or valve
variability failure.
throughout
replicates
(continued).

Luminometer problem. Call Technical Support.

High RLU mean. The System Check is not diluted or Use a new aliquot of undiluted System
improperly diluted, or the cups are Check Solution and prepare a new 1/501
out of order in the maintenance dilution. Run the System Check again. Refer
tray. to Section 8.4, Weekly Maintenance of the
Operator’s Guide to review the correct
System Check procedure.

Wash/read carousel or substrate Check the Wash Crsl. and Substrate


temperatures are out of range temperatures on the Maintenance screen by
high. Result may be flagged TMP. pressing [F6] Maint. from the Main Menu. If
either the Wash Crsl. or Substrate
temperatures are displayed in red (out of
range), call Technical Support.

Contaminated substrate supply. 1. Call Technical Support to verify the


need to perform the Substrate
Decontamination procedure described
in Section 6.2 in this manual. After
performing substrate decontamination
procedure, repeat the System Check
procedure.
2. If the System Check fails, install a new
bottle of substrate and repeat the
System Check procedure. (For revision
B fluidics, be sure to run one complete
cycle of air through the substrate line
before placing the substrate cap on the
new substrate bottle, as specified in the
decontamination procedure.) If the
check fails again, call Technical Support.

Substrate pump delivering too Run the Visual Substrate Volume Check
much substrate. procedure and follow the instructions
appropriate to the results. Refer to Section
6.8 of this manual for this procedure. If the
Visual Substrate Volume Check does not
fail, continue troubleshooting.

Luminometer problem. Call Technical Support.

3/00 © 2000 Copyright Beckman Coulter, Inc.


5-6 Rev 101740L Access Reference Manual
System Check Troubleshooting

System Check Problems—Substrate Check (continued)


Symptom Possible Causes Corrective Action

Low RLU mean. Expired substrate. Check the install date in the event log.
Install a new bottle of substrate, as needed.

Inconsistent substrate delivery Check the substrate supply bottle and


due to insufficient supply. replenish, if necessary, using the Supplies or
Supplies Required screen. Refer to Section
2.6, Substrate of the Operator’s Guide more
information.

Wash/read carousel or substrate Check the Wash Crsl. and Substrate


temperatures are out of range low. temperatures on the Maintenance screen by
Result may be flagged TMP. pressing [F6] Maint. from the Main Menu. If
either the Wash Crsl. or Substrate
temperatures are displayed in red (out of
range), call Technical Support.

Incomplete priming after substrate Prime the substrate by pressing [F6] Maint.
decontamination. from the Main Menu, [F4] Fluidics Priming,
then [F3] Substrate. Repeat the System
Check procedure.

Substrate bottle is contaminated Install a new bottle of substrate.


with Contrad 70 cleaning solution;
caused by error in performing
decontamination procedure.

Substrate dispense volume too Call Technical Support.


low.

Luminometer problem. Call Technical Support.

Unwashed Begin troubleshooting the Unwashed Check out-of-range results when the
Check Substrate Check results are within expected ranges. The troubleshooting
Problems information for the Unwashed Check focuses on problems with the pipetting
system and does not provide detail on problems related to the substrate system.

System Check Problems—Unwashed Check


Symptom Possible Causes Corrective Action

High % CV. A kink in the wash buffer supply Visually inspect tubing for kinks from the
lines. wash buffer supply to the main pipettor.
Straighten kinked tubing if found. Then,
prime the pipetting system by pressing
[F6] Maint. from the Main Menu,
[F4] Fluidics Priming, then [F1]Pipettor.

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 5-7
System Check Troubleshooting

System Check Problems—Unwashed Check (continued)


Symptom Possible Causes Corrective Action

High % CV Out of wash buffer. Check the wash buffer supply in the fluids
(continued). tray. If empty, replenish the wash buffer as
described in Chapter 2 of the Operator’s
Guide; however, before replenishing the
wash buffer, check the wash buffer icon on
the Main Menu. If it is not red when the
system is out of wash buffer, call Technical
Support.

Worn or damaged precision pump Revision A fluidics:


seals. Call Technical Support to confirm whether
you need to replace precision pump seals.
Refer to Chapter 6 for the seal replacement
procedure only as instructed by Technical
Support.

Revision B fluidics:
Call Technical Support.

Precision pump, valve, fittings, or Examine the precision pump, valve, fittings
tubing damaged and leaking. (2 fittings), and tubing (from the precision
valve to the primary pipettor) for leaks and/
or salt deposits. If any are found, call
Technical Support.

Problems with the substrate If the Substrate Check % CV results are


system that are due to any of the within expected ranges, you can rule out
following causes: these causes. If the Substrate Check results
are not within expected ranges, refer to
• Insufficient substrate supply.
Substrate Check troubleshooting for high
• Air in substrate lines. % CV.
• A leak in the substrate system.
• A kink in the substrate lines.
• A bent substrate probe.
• Substrate pump or valve
failure.

Partially plugged primary probe. Call Technical Support.

Splashing in the reaction vessels. Call Technical Support.

Luminometer problem. Call Technical Support.

High RLU mean. Improperly prepared or no Use a new aliquot of undiluted System
dilution in the System Check Check Solution and prepare a new 1/501
maintenance tray. dilution. Run the System Check again. Refer
to Section 8.4, Weekly Maintenance of the
Operator’s Guide to review the correct
System Check procedure.

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5-8 Rev 101740L Access Reference Manual
System Check Troubleshooting

System Check Problems—Unwashed Check (continued)


Symptom Possible Causes Corrective Action

High RLU mean Problems with the substrate If the Substrate Check RLU mean results are
(continued). system that are due to any of the within expected ranges, you can rule out
following causes: these causes. If the Substrate Check results
are not within expected ranges, refer to
• Wash/read carousel or
Substrate Check troubleshooting for high
substrate temperatures that
RLU mean.
are too high.
• A contaminated substrate
supply.
• The substrate pump
delivering too much substrate.

Luminometer problem. Call Technical Support.

Low RLU mean. Improperly prepared or no Use a new aliquot of undiluted System
dilution in the System Check Check Solution and prepare a new 1/501
maintenance tray. dilution. Run the System Check again. Refer
to Section 8.4, Weekly Maintenance of the
Operator’s Guide to review the correct
System Check procedure.

System Check dilution stored Using a fresh bottle of System Check


improperly or for too long, or solution, prepare a new 1/501 dilution.
System Check solution expired. Repeat the Unwashed Check procedure.

Problems with the substrate If the Substrate Check RLU mean results are
system that are due to any of the within expected ranges, you can rule out
following causes: these causes. If the Substrate Check results
are not within expected ranges, refer to
• Expired substrate.
Substrate Check troubleshooting for low
• Insufficient substrate supply. RLU mean.
• Wash/read carousel or
substrate temperatures that
are out of range low.
• Incomplete priming after
substrate decontamination.
• Substrate supply
contaminated with Contrad 70
cleaning solution.
• Substrate dispense volume too
low.

Luminometer problem. Call Technical Support.

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Access Reference Manual Rev 101740L 5-9
System Check Troubleshooting

Washed Begin troubleshooting the Washed Check out-of-range results when the Substrate
Check Check and the Unwashed Check results are within expected ranges. The
Problems troubleshooting information for the Washed Check focuses on problems with the
reaction vessel wash system, and does not provide detail on problems related to
the substrate or the pipetting system.

System Check Problems—Washed Check


Symptom Possible Causes Corrective Action

High % CV. Incomplete aspiration of reaction Clean the aspirate probes. Refer to the
vessels due to dirty or plugged Replacing and Cleaning Aspirate Probes
aspirate probes. heading of Section 8.4, Weekly Maintenance
of the Operator’s Guide for instructions.

Incomplete aspiration of reaction Inspect the aspirate probes on the wash arm.
vessels due to damaged aspirate Replace bent probes. Refer to Section 8.4,
probes. Weekly Maintenance in the Operator’s Guide
for the identification of, and replacement
procedure for, aspirate probes. If problem
persists, call Technical Support.

Incomplete aspiration of reaction Call Technical Support.


vessels due to plugged waste air
filter.

Revision A fluidics: Visually inspect the 6 fluid fittings on the


Incomplete aspiration of reaction waste valve for leakage. If leak found, call
vessels due to loose fittings on Technical Support for assistance.
waste valve.

Revision B fluidics: Inspect the tubing, and the area under the
Incomplete aspiration of reaction tubing, from the peristaltic waste pump to
vessels due to damaged peristaltic the aspirate probes for crystalline deposits.
waste pump tubing. Deposits may indicate that the tubing is
damaged and should be replaced. Call
Technical Support for assistance. Refer to
the Chapter 6 tubing replacement procedure
only when instructed by Technical Support.

One or more aspirate probes stuck Verify up and down movement of the
in “up” position. aspirate probes. Refer to Section 8.4, Weekly
Maintenance in the Operator’s Guide for
identification of the aspirate probes. Lightly
grasp the probe below the wash arm. The
probes are spring loaded and should move
SLIGHTLY up and down. If not moving
freely, replace the probe(s). Refer to Section
8.4 of the Operator’s Guide.

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5-10 Rev 101740R Access Reference Manual
System Check Troubleshooting

System Check Problems—Washed Check (continued)


Symptom Possible Causes Corrective Action

High % CV Insufficient wash buffer volume Visually inspect tubing for kinks from the
(continued). due to kinks in tubing or air in wash buffer supply to the dispense probes.
wash pump system. Straighten kinked tubing if found. Then,
prime the dispense probes by pressing
[F6] Maint. from the Main Menu,
[F4] Fluidics Priming, then
[F2] Dispense Probes.

Problems with the substrate If the Substrate Check % CV results are


system that are due to any of the within expected ranges, you can rule out
following causes: these causes. If the Substrate Check results
are not within expected ranges, refer to
• Insufficient substrate supply.
Substrate Check troubleshooting for high
• Air in substrate lines. % CV.
• A leak in the substrate system.
• A kink in the substrate lines.
• A bent substrate probe.
• Substrate pump or valve
failure.

Problems with the pipetting If the Unwashed Check % CV results are


system that are due to any of the within expected ranges, you can rule out
following causes: this cause. If the Unwashed Check results
• Out of wash buffer. are not within expected ranges, refer to
Unwashed Check troubleshooting for high
• Worn or damaged precision % CV.
pump seals.
• Partially plugged primary
probe.
• Precision pump, valve,
fittings, or tubing damaged
and leaking.

Incomplete aspiration of reaction Call Technical Support.


vessels due to incorrect aspirate
probe height.

Incomplete aspiration of reaction Call Technical Support.


vessels due to defective waste
pump.

Reaction vessel mixing problem. Call Technical Support.

Splashing in the reaction vessels. Call Technical Support.

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 5-11
System Check Troubleshooting

System Check Problems—Washed Check (continued)


Symptom Possible Causes Corrective Action

High RLU mean. Incomplete aspiration of reaction Clean the aspirate probes. Refer to the
vessels due to dirty or plugged Replacing and Cleaning Aspirate Probes
aspirate probes. heading of Section 8.4, Weekly Maintenance
of the Operator’s Guide for instructions.

Incomplete aspiration of reaction Inspect the aspirate probes on the wash arm.
vessels due to damaged aspirate Replace bent probes. Refer to Section 8.4,
probes. Weekly Maintenance in the Operator’s Guide
for the identification of, and replacement
procedure for, aspirate probes. If problem
persists, call Technical Support.

One or more aspirate probes stuck Verify up and down movement of the
in “up” position. aspirate probes. Refer to Section 8.4, Weekly
Maintenance in the Operator’s Guide for
identification of the aspirate probes. Lightly
grasp the probe below the wash arm. The
probes are spring loaded and should move
SLIGHTLY up and down. If not moving
freely, replace the probe(s). Refer to Section
8.4 of the Operator’s Guide.

Problems with the substrate If the Substrate Check RLU mean results are
system that are due to any of the within expected ranges, you can rule out
following causes: these causes. If the Substrate Check results
are not within expected ranges, refer to
• Wash/read carousel or
Substrate Check troubleshooting for high
substrate temperatures that
RLU mean.
are too high.
• A contaminated substrate
supply.
• The substrate pump
delivering too much substrate.

Incomplete aspiration of reaction Call Technical Support.


vessels due to incorrect aspirate
probe height.

Luminometer problem. Call Technical Support.

Low RLU mean. Diluted System Check solution Reload sample cup number one with neat
used instead of neat. Sample cup System Check solution and number four
number one may have been with 1/501 diluted System Check, and
prepared with the incorrect repeat the System Check procedure.
solution, or cup numbers one and
four may have been switched
when placed in the tray.

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5-12 Rev 101740L Access Reference Manual
System Check Troubleshooting

System Check Problems—Washed Check (continued)


Symptom Possible Causes Corrective Action

Low RLU mean Main pipettor not delivering If the Unwashed Check % CV results are
(continued). sufficient volume. within expected ranges, you can rule out
this cause. If the Unwashed Check results
are not within expected ranges, refer to
Unwashed Check troubleshooting for high
% CV.

Incomplete aspiration of reaction Clean the aspirate probe. Refer to the


vessels due to plugged aspirate Replacing and Cleaning Aspirate Probes
probe number three only. heading of Section 8.4, Weekly Maintenance
of the Operator’s Guide for instructions.

Problems with the substrate If the Substrate Check % CV and RLU mean
system that are due to any of the results are within expected ranges, you can
following causes: rule out these causes. If the Substrate Check
• Air in substrate lines. results are not within expected ranges, refer
to Substrate Check troubleshooting for high
• A leak in the substrate system. % CV and low RLU mean.
• A kink in the substrate lines.
• A bent substrate probe.
• Substrate pump or valve
failure.
• Expired substrate.
• Insufficient substrate supply.
• Wash/read carousel or
substrate temperatures that
are out of range low.
• Incomplete priming after
substrate decontamination.
• Substrate supply
contaminated with Contrad 70
cleaning solution.
• Substrate dispense volume too
low.

Luminometer problem. Call Technical Support.

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 5-13
System Check Troubleshooting

System Check Problems—Wash Efficiency


Symptom Possible Causes Corrective Action

Wash Efficiency Washed Check mean RLUs or Refer to Washed Check troubleshooting for
ppm fail to meet % CV too high. high % CV and high RLU mean.
criteria.

Unwashed Check mean RLUs too Refer to Unwashed Check troubleshooting


low. for low RLU mean.

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5-14 Rev 101740L Access Reference Manual
Instrument Troubleshooting

5.3
Instrument Troubleshooting
Instrument troubleshooting information can help you identify and correct
instrument problems that are not resolved during System Check troubleshooting.

The information is sorted in the following order:


• General Instrument Troubleshooting
• Start-Up Problems
• Power Problems
• Keyboard Problems
• Bar Code Reading Problems
• Air in System
• Main Pipettor Problems

The troubleshooting tables identify symptoms, list possible causes for the
symptoms, and provide the corrective action for each cause.

If you are unable to identify the cause of a problem or if the problem persists after
performing the specified troubleshooting procedure(s), call Technical Support for
assistance.

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 5-15
Instrument Troubleshooting

General Instrument Troubleshooting


Symptom Possible Causes Corrective Action

System mode NOT There are multiple circumstances,


READY (person such as the front panel of the CAUTION
tying shoes) and analyzer is open, or a device
the system is not motion error is detected, which If the system is not ready because you
currently cause the system to be in the NOT pressed [F8] Cancel during a maintenance
rebooting or being READY mode. procedure, call Technical Support for
initialized. instructions before initializing.

The system must be re-initialized.


• If you are not experienced at initializing
the system or you are not following
written instructions in this manual or in
the Operator’s Guide, call Technical
Support for instructions.
• If you are experienced at initializing the
system and are following written
instructions in this manual or in the
Operator’s Guide, initialize the system.
Refer to Chapter 4, System Diagnostics,
as needed.

The background A fatal system event has occurred Print the Event Log by pressing
of the Event Log and a test was cancelled. [Scroll Lock], then [F7] Print Event Log. The
icon is red. Event Log message identifies the exact
problem. Refer to the related symptom in
this chapter for instructions.

The result of the test being performed


when the fatal event occurred will be the
obtained RLUs and the appropriate flag.
There will not be a calculated
concentration. To obtain a result, enter a
new test request.

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5-16 Rev 101740L Access Reference Manual
Instrument Troubleshooting

General Instrument Troubleshooting (continued)


Symptom Possible Causes Corrective Action

The background A non-fatal system event has Review the Event Log, by pressing
of the Event Log occurred, test results were [Scroll Lock], and identify the problem.
icon is red calculated, and no tests were Typical problems with corrective actions:
(continued). cancelled.
• If an RV ejected with no waste bag
present, properly install the waste bag.
• If the dark count is too high, perform the
test again. If high dark counts occur
with increasing frequency, call Technical
Support.

NOTE
Dark counts measure the background
light in the instrument in RLUs when
no transmission is occurring. When
dark counts exceed expected results,
an error is posted to the event log.
High dark counts would affect
results.

For other problems or further instructions,


call Technical Support.

The background Memory allocation error. Reboot the system. Refer to Section 6.6 in
of the Event Log this manual for detailed information.
icon is red and the
“Unable to
allocate memory”
message is
recorded in the
Event Log.

The background The software has encountered an Reboot the system. Refer to Section 6.6 in
of the Event Log unexpected condition. this manual for detailed information.
icon is red and the
“Assertion error
‘xyz = = NULL’ in
file abc, line n”
message is
recorded in the
Event Log (letters
in italics are
variables).

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 5-17
Instrument Troubleshooting

General Instrument Troubleshooting (continued)


Symptom Possible Causes Corrective Action

The background A fatal system event has occurred Prepare a fresh aliquot of the patient sample
of the Event Log because of insufficient sample or maintenance solution and perform the
icon is yellow and quantity. test or System Check again.
a “level sense”
error is logged. A
test result is
flagged QNS or a
maintenance
result is cancelled.

There is A fatal system event has occurred Print the Event Log by pressing
apparently because of level sense failure or [Scroll Lock], then [F7] Print Event Log. The
enough fluid in sample carousel positioning error. Event Log message identifies the exact
the sample problem. Typical corrective actions:
container, yet the
• Change to the correct sample container
background of the
and/or sample tray. Ensure that the
Event Log icon is
sample containers are placed only in a
yellow and a
sample tray with the appropriate Tray
“level sense” error
ID. Refer to Chapter 4 of the Operator’s
is logged. A test
Guide for detailed sample container and
result is flagged
tray information.
QNS or a
maintenance • Ensure that the sample container is fully
result is cancelled. seated in the sample tray.
• Ensure that the sample tray is properly
installed on the carousel. Refer to
Section 4.3, Sample Trays, of the
Operator’s Guide for installation
instructions.
For other problems or further instructions,
call Technical Support.

A fatal system event has occurred Ensure that the fluid in the sample container
because the fluid level exceeds the does not exceed the top of the container and
top of the sample container. perform the test or System Check again.

The background A non-fatal system event has Review the Event Log, by pressing
of the Event Log occurred because of a supply [Scroll Lock] to confirm the problem. Add
icon is yellow and shortage. supplies or empty waste containers as
one or more described in the appropriate section of the
supply status Operator’s Guide, Chapter 2, Supplies. For
icons are red. The other problems or further instructions, call
scheduler is Technical Support.
paused and no
new tests are
started.

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5-18 Rev 101740L Access Reference Manual
Instrument Troubleshooting

General Instrument Troubleshooting (continued)


Symptom Possible Causes Corrective Action

The background A non-fatal system event has Review the Event Log, by pressing
of the Event Log occurred that is not related to [Scroll Lock]. The Event Log message
icon is yellow, needed supplies or the available identifies the exact problem. The result of
there is no QNS waste area. the test being performed when the non-
flag, and no fatal event occurred may be flagged.
supply status Review the result to determine if the test
icons are red. should be repeated. For information about
result flags, refer to the Operator’s Guide,
Chapter 5, Sample Results. If necessary, call
Technical Support for assistance.

Start-Up Problems
Symptom Possible Causes Corrective Action

System fails to No power to analyzer. Refer to the Power Problems


initiate boot. troubleshooting section.

Data diskette in the floppy disk Remove diskette from floppy drive and
drive. reboot.

Hardware (power supply, hard Reboot the system. Refer to Section 6.6 in
disk drive, CPU printed circuit this manual for detailed information.
board) or software failure.

System fails Interlock switch detects the front Close the front panel of the analyzer and
during system panel of the analyzer is open. perform system initialization (refer to
initialization. Section 4.3, Diagnostics Screen, in this
manual).

A device motion error (i.e., device Display the Event Log, by pressing
failed to home or return to its [Scroll Lock], then press [F7] Print Event
starting position) or the system Log to obtain a copy of the entry. Call
software is defective. Technical Support.

Power Problems
Symptom Possible Causes Corrective Action

No power to Faulty power outlet. Plug the analyzer and printer into a
analyzer or different power outlet. If problem persists,
printer. perform Power Problems troubleshooting
for analyzer and printer individually, then
call Technical Support.

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 5-19
Instrument Troubleshooting

Power Problems (continued)


Symptom Possible Causes Corrective Action

No power to Analyzer power switch not turned Turn on power switch located on the right
analyzer. on. side of the analyzer.

Power cord connector loose on Ensure that the power cord connections to
either end. outlet and to analyzer are secure.

Faulty system power supply or Call Technical Support.


circuit breaker.

No power to Printer power switch not turned Turn on printer power switch located on the
printer. on. lower left front corner of the printer.

Printer power cord connector Ensure that the power cord connections to
loose on either end. outlet and to printer are secure.

Printer is defective. Call Technical Support.

Keyboard Problems
Symptom Possible Causes Corrective Action

No response from Connector loose. Ensure that the cable connections (located
keyboard. on the right side of the analyzer) between
the keyboard, bar code wand, and the
analyzer are secure.

Invalid key pressed. Refer to the prompt line on the screen to


verify the key pressed is an acceptable
keyboard response.

System software is not responding. Reboot the system. Refer to Section 6.6 in
this manual for detailed information.

Hardware problem. Call Technical Support.

3/00 © 2000 Copyright Beckman Coulter, Inc.


5-20 Rev 101740L Access Reference Manual
Instrument Troubleshooting

Bar Code Reading Problems


Symptom Possible Causes Corrective Action

Tray bar code not Internal bar code reader Configure the internal bar code reader on,
read by internal configured off. according to procedures in Section 7.2,
bar code reader. Configure System.

Bar code label not correctly placed Reapply the bar code label correctly on the
on the tray. tray, according to procedures in Section 1.5,
Bar Code Readers/Scanners.

System software version 3.27 or New tray labels, which can be identified by
higher is installed, and the tray has the line under the tray number (refer to
an obsolete tray label. Figure 1-29 for an example), must be used
with system software version 3.27 or higher.
Remove the obsolete tray label and apply a
current label.

Bar code reader not operating Call Technical Support. Until the problem is
properly. corrected, you can configure the reader off
and type the Tray IDs and Sample IDs or
scan the labels with the external bar code
reader. Refer to Section 7.2, Configure
System for configuration procedures.

Sample bar code Sample container not correctly Turn the sample container in the tray until
not read by placed in the tray. its bar code label faces the same direction as
internal bar code the tray bar code label, and the bar code is
reader. fully is visible through the slot in the tray.

Bar code label not correctly placed Verify that the bar code label is placed
on the sample. correctly on the sample container, according
to procedures in Section 1.5, Bar Code
Readers/Scanners. Reapply if needed.

Internal bar code reader not Configure the internal bar code reader
configured properly for the parameters to match the bar code
sample bar code symbology. symbology you are using. Refer to Section
7.3, Configure Internal Bar Code Reader for
configuration information.

Bar code symbology not Verify that the bar code symbology used on
supported. the sample label is supported, according to
Section 2.2, Performance Characteristics. If
the symbology is not supported, consult
with Technical Support to identify a
solution.

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 5-21
Instrument Troubleshooting

Bar Code Reading Problems (continued)


Symptom Possible Causes Corrective Action

No response from Incorrect scanning technique. Verify that the correct screen is displayed for
external bar code the item you are scanning, and that the
wand. cursor is in the correct field. Review
scanning procedures in Section 1.5, Bar
Code Readers/Scanners. Try scanning
again.

You are trying to add more than You can add only one calibrator lot (with
one calibrator lot on the same any related levels) on the Add Calibrator
screen. Lot screen. After saving the information,
press [Esc] to return to the Configure
Calibrator screen and press [F1] Add Lot to
add another calibrator lot.

Connector loose. Ensure that the cable connections (located


on the right side of the analyzer) between
the keyboard, bar code wand, and the
analyzer are secure.

System software is not responding. Reboot the system. Refer to Section 6.6 in
this manual for detailed information.

Bar code wand not configured Call Technical Support.


properly.

Hardware problem. Call Technical Support.

Air in System
Symptom Possible Causes Corrective Action

Air in fluid lines. Insufficient priming. Prime the system by pressing [F6] Maint.
from the Main Menu, [F4] Fluidics Priming,
(use the default number of cycles displayed
for each component), then press [F5] All. If
problem persists, call Technical Support.

System “de-primed” due to a leak Ensure a secure connection between the


in the fluidic system. fittings (located on the left side of the
analyzer) and the fluids tray. Visually
inspect the fluidic module for fluid leaks or
deposits. Inspect the precision pump for
deposits, then call Technical Support for
further instructions.

3/00 © 2000 Copyright Beckman Coulter, Inc.


5-22 Rev 101740L Access Reference Manual
Instrument Troubleshooting

Air in System (continued)


Symptom Possible Causes Corrective Action

Air in fluid lines Kinked tubing at fluids tray. Visually inspect tubing for kinks to and
(continued). from the substrate pump/ heater assembly
(refer to Chapter 1 for part locations).
Straighten kinked tubing if found. Then,
prime the system by pressing [F6] Maint.
from the Main Menu, [F4] Fluidics Priming,
then [F5] All.

Increased pressure in system due Check the waste filter bottle for fluid; if
to plugged waste filter. present, empty the bottle as described in
Section 6.16, Replacing the Waste Filter
Bottle.

Main Pipettor Problems


Symptom Possible Causes Corrective Action

Fluid dispensed Probe partially clogged. Run the Special Clean procedure. Refer to
from primary Section 6.13 for instructions. If problem
probe with excess persists, call Technical Support for further
pressure. instructions.

Primary probe Primary probe tip is partially Run the Special Clean procedure. Refer to
leaking. clogged. Section 6.13 for instructions. If problem
persists, call Technical Support for further
instructions.

Loose fitting between primary Revision A fluidics:


probe and precision pump valve. Visually inspect the fittings between the
primary probe and precision pump valve
(refer to Chapter 1 for part locations) for
fluid leaks or deposits. Follow the fluid
tubing lines extending from the right side of
the pump to the precision pump valve.
Inspect all the fluid fittings on this valve.
Call Technical Support for assistance.

Revision B fluidics:
Visually inspect the fittings between the
primary probe and precision pump valve
for fluid leaks or deposits (refer to Chapter 1
for part locations). Inspect all the fluid
fittings to the manifold. Call Technical
Support for assistance.

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 5-23
Assay Troubleshooting

5.4
Assay Troubleshooting
The following troubleshooting tables are provided to help you identify and
correct assay problems. The information is organized by calibration, quality
control, and patient sample problems. The troubleshooting tables identify
symptoms, list possible causes for the symptoms, and provide the corrective
action for each cause.

Various system parameters are monitored by the system and can aid in
troubleshooting. Refer to Chapter 4, System Diagnostics, for a description of the
Event Log and the Diagnostics screen.

If you are unable to identify the cause of a problem or if the problem persists after
performing the specified troubleshooting procedure(s), call Technical Support for
assistance.

3/00 © 2000 Copyright Beckman Coulter, Inc.


5-24 Rev 101740L Access Reference Manual
Assay Troubleshooting

Calibration When calibration results are rejected, rejection codes are displayed on the Last
Run Calibration screen. Use the following table to assist you in troubleshooting
rejected calibrations. Additional information about calibration is available
through the following references:
• For calibration theory, refer to Chapter 3, Theory of Operation.
• For reviewing calibrations, refer to Chapter 6, Assay Calibration, of the
Operator’s Guide.
• For doing calibrations, refer to Section 7.6, Configure Calibrators and
Calibration Controls, of this manual, and Section 3.9, Calibrator/Calibration
Control Test Request Entry in the Operator’s Guide.

Calibration Problems
Symptom Possible Causes Corrective Action

Calibration is Quantity of calibrator(s) or Ensure that enough calibrator or calibration


rejected. Reason calibration control(s) is not control is pipetted into each sample
displayed in Last sufficient for testing. Level sense container, then recalibrate. (If using 2.0 mL
Run Calibration error or results flagged QNS. sample cups, ensure that at least 500 mL is
screen: Insuff pipetted into each container. If using other
Data. containers, refer to Chapter 4 of the
Operator’s Guide for the correct minimum
volume.) If calibration is rejected again, call
Technical Support for assistance.

Two or more replicates were not Review the event log for device errors prior
calculated due to an instrument to the calibration rejection. Troubleshoot the
error. device errors. Contact Technical Support for
assistance.

Calibration is Wrong calibrator or calibration Ensure that the correct calibrator or


rejected. Reason control set loaded onto sample calibration control set is loaded, then
displayed in Last tray. recalibrate.
Run Calibration
screen: No Fit, Wrong reagent pack loaded or Verify the location of all on-board reagent
Max Iter, Bad Fit, reagent pack placed in wrong packs by unloading each, checking that the
Resp. Delta, or CV position on reagent carousel. reagent pack code on the screen matches
Std 0, or Limits. that on the label and reloading the reagent
Precision is pack. If the reagent pack is on-board but is
generally good not presented during this process, call
but curve is flat; Technical Support for assistance.
for qualitative
assay, no curve.

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 5-25
Assay Troubleshooting

Calibration Problems (continued)


Symptom Possible Causes Corrective Action

Calibration is For qualitative assay (reason Be sure that the calibrators or calibration
rejected. Reason displayed: Limits), calibrators or control set are loaded in the proper order,
displayed in Last calibration control set out of order. then recalibrate.
Run Calibration
screen: No Fit, Calibrator or control set expired. Unload expired calibrator or calibration
Max Iter, Bad Fit, Check expiration date in the control set, load new set, then recalibrate.
Resp. Delta, CV Request Calibrator screen.
Std 0, or Limits. Unstable/contaminated calibrator Unload calibrator or calibration control set,
Precision is or calibration control set due to load new set, then recalibrate.
generally good. improper handling.

Unstable/contaminated reagent Unload reagent pack, load new reagent


pack due to improper handling. pack, then recalibrate.

Substrate supply depleted. Check that the substrate bottle is not empty.
Replenish substrate supply as necessary,
then recalibrate.

Contaminated substrate. Perform System Check procedure (refer to


Chapter 8 of the Operator’s Guide and
Section 6.7 of this manual). If the expected
results listed in the procedure are not
obtained, refer to the Section 5.2, System
Check Troubleshooting tables. Refer to
Section 6.2, Substrate Decontamination only
as instructed by Technical Support.

Incorrect calibration information Verify calibration information in system


entered for system configuration. configuration and correct as needed. Refer
to Section 7.6, Configure Calibrators and
Calibration Controls.

Calibration is Daily maintenance not performed Perform daily maintenance before


rejected. Reason today. calibrating. Refer to Section 8.3, Daily
displayed in Last Maintenance, in the Operator’s Guide.
Run Calibration
screen: No Fit, Air in fluid lines. Refer to Section 5.3, Instrument
Max Iter, Bad Fit, Troubleshooting, Air in System.
Resp. Delta, CV Partially used pack loaded on a Repeat the calibration with a full reagent
Std 0, or Limits. different instrument or reagent pack.
Precision is leaked out of pack while stored off
generally poor. board.

Access instrument problem. Run the System Check procedure. If the


System Check fails, troubleshoot the
problem as described in Section 5.2, System
Check Troubleshooting.

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5-26 Rev 101740L Access Reference Manual
Assay Troubleshooting

Quality When a quality control result fails to meet the criteria for an applied QC rule, the
Control background of the Quality Control icon turns red. The icon background remains
red until the QC Data screen is viewed. For information about reviewing quality
control results, refer to Section 7.2, Reviewing Assay Quality Control Data, in the
Operator’s Guide.

Before using this section to troubleshoot a quality control problem, run the
System Check procedure. If the System Check fails, troubleshoot the problem as
described in Section 5.2, System Check Troubleshooting. Running the System
Check will rule out or help identify QC problems such as:
• Inadequate washing due to aspirate probes not aspirating fluid—detect with
the Substrate Check or the Washed Check results
• Expired or contaminated substrate—detect with the Substrate Check, the
Washed Check, or the Wash Efficiency calculation results
• Inaccurate substrate delivery due to air in the line—detect with the Substrate
Check results
• Inaccurate sample or reagent delivery due to leak in main pipettor lines—
detect with the Unwashed Check results

Quality Control Problems


Symptom Possible Causes Corrective Action

Controls do not Daily maintenance not performed Perform daily maintenance before running
meet applied QC today. controls. Refer to Section 8.3, Daily
rule. Maintenance, in the Operator’s Guide.

Wrong control loaded onto sample Unload incorrect control, load correct
tray. control, then repeat test(s).

Wrong lot number selected for test. Repeat test with correct lot number.

Wrong mean and/or standard Verify control information in system


deviation information entered for configuration. Refer to Section 7.7,
system configuration. Configure Controls. Correct as needed, and
repeat test(s).

Wrong sample type. Verify that the sample type matches the type
indicated in the test request, and also
matches the sample type configured for the
control. If not, correct and repeat test(s).

Controls expired, lots expired. Unload expired controls, load new controls,
then repeat test(s).

Unstable/contaminated controls Unload controls, load new controls, then


due to improper handling. repeat test(s).

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Access Reference Manual Rev 101740L 5-27
Assay Troubleshooting

Quality Control Problems (continued)


Symptom Possible Causes Corrective Action

Controls do not Controls improperly reconstituted. Unload controls, reconstitute new controls
meet applied QC (as directed by the manufacturer) and load,
rule (continued). then repeat test(s).

Quantity of control was not Ensure that enough control is pipetted into
sufficient for the sample container each sample container. (If using 2.0 mL
used. sample cups, ensure that at least 500 mL is
pipetted into each container. If using other
containers, refer to Chapter 4 of the
Operator’s Guide for the correct minimum
volume.)

Controls have evaporated. Load a fresh aliquot of each control, then


repeat test(s). If using 2.0 mL sample cups,
ensure that the control is run less than one
hour after the sample container is loaded
onto the system. If using 3.0 mL sample
containers, the control may be on the system
up to two hours before being run.

Unstable/contaminated reagent Unload reagent pack, load new reagent


pack. pack, then repeat test(s).

Wrong reagent pack loaded or Verify the location of all on-board reagent
reagent pack placed in wrong packs by unloading each, checking that the
position on reagent carousel. reagent pack code on the screen matches
that on the label and reloading the reagent
pack. If the reagent pack is on-board but is
not presented during this process, call
Technical Support for assistance.

Reagent pack expired. Check Unload expired reagent pack, load new
reagent pack expiration date in the reagent pack, then repeat test(s).
Reagent Inventory screen.

Wrong sample container and/or Use only the recommended sample


sample tray used. containers. Ensure that the sample
containers are only placed in a sample tray
with the appropriate Tray ID. Refer to
Chapter 4 of the Operator’s Guide for detailed
sample container and tray information.

Assay calibration expired. Check Recalibrate assay, then repeat test(s).


calibration expiration date in the
Reagent Inventory screen.

Preventive maintenance or repair Recalibrate assay, then repeat test(s).


has been performed since last
calibration.

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5-28 Rev 101740L Access Reference Manual
Assay Troubleshooting

Quality Control Problems (continued)


Symptom Possible Causes Corrective Action

Controls do not Quantity of sample is not Ensure that enough sample is pipetted into
meet applied QC sufficient for testing. Level sense each sample container, then repeat test(s).
rule (continued). error or results flagged QNS.

Substrate not at room temperature Substrate must be equilibrated to room


prior to loading on the system. temperature for specified period prior to
loading on the system. Refer to the product
insert for detailed information.

Increasing values Sample evaporation. Load a fresh aliquot of each sample, then
across the run. repeat test(s). Ensure 2 mL sample cups and
all insert cups are on board no longer than 1
hour before the sample is aspirated. Ensure
that 3 mL sample containers are on board no
longer than 2 hours before the sample is
aspirated.

Patient Sample Problems


Symptom Possible Causes Corrective Action

Sample values not Inappropriate sample type used. Refer to the product insert for appropriate
as expected. sample types.

Sample improperly handled. Ensure that the sample was stored and
handled according to proper laboratory
procedures. Refer to individual assay inserts
for proper sample handling instructions.

If serum, sample microclots Spin the sample again or use a serum filter.
present. Repeat test.

Quantity of sample was not Ensure that enough sample is pipetted into
sufficient for the sample container each sample container. (If using 2.0 mL
used. sample cups, ensure that 500 mL is pipetted
into each container. If using other
containers, refer to Chapter 4 of the
Operator’s Guide for the correct minimum
volume.)

Quantity of sample is not Ensure that enough sample is pipetted into


sufficient for testing. Level sense each sample container, then repeat test(s).
error and/or results flagged QNS.

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Access Reference Manual Rev 101740L 5-29
Assay Troubleshooting

Patient Sample Problems (continued)


Symptom Possible Causes Corrective Action

Sample values not Samples have evaporated. Load a fresh aliquot of each sample, then
as expected repeat test(s). Ensure 2 mL sample cups and
(continued). all insert cups are not on board longer than 1
hour before the sample is aspirated. Ensure
that 3 mL sample containers are not on
board longer than 2 hours before the sample
is aspirated.

Wrong reagent pack loaded or Verify the location of all on-board reagent
reagent pack placed in wrong packs by unloading each, checking that the
position on reagent carousel. reagent pack code on the screen matches
that on the label and reloading the reagent
pack. If the reagent pack is on-board but is
not presented during this process, call
Technical Support for assistance.

Reagent pack expired. Check Unload expired reagent pack, load new
reagent pack expiration date in the reagent pack, then repeat test(s).
Reagent Inventory screen.

Assay calibration expired. Check Recalibrate assay and run controls, then
calibration expiration date in the repeat test(s).
Reagent Inventory screen.

Preventive maintenance or repair Recalibrate assay and run controls, then


has been performed since last repeat test(s).
calibration.

Partial bottles of substrate have Replace and prime a new, full bottle of
been combined. substrate by pressing [F6] Maint. from the
Main Menu, [F4] Fluidics Priming, then
[F3] Substrate. Repeat test(s).

Access instrument problem, such Run the System Check procedure. Refer to
as inadequate washing, poor main Section 8.4, Weekly Maintenance of the
pipettor precision, dirty aspirate Operator’s Guide to review the procedure
probes, substrate expired or and expected results. For out of range
contaminated. results, refer to the Section 5.2, System
Check Troubleshooting tables.

Daily maintenance not performed Perform daily maintenance before running


today. patient samples. Refer to Section 8.3, Daily
Maintenance, in the Operator’s Guide.

Wrong sample container and/or Use only the recommended sample


sample tray used. containers. Ensure that the sample
containers are placed only in a sample tray
with the appropriate Tray ID. Refer to
Chapter 4 of the Operator’s Guide for detailed
sample container and tray information.

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5-30 Rev 101740L Access Reference Manual
Assay Troubleshooting

Patient Sample Problems (continued)


Symptom Possible Causes Corrective Action

High sample Sample evaporation. Load a fresh aliquot of each sample, then
values. repeat test(s). Ensure 2 mL sample cups and
all insert cups are not on board longer than 1
hour before the sample is aspirated. Ensure
that 3 mL sample containers are not on
board longer than 2 hours before the sample
is aspirated.

LOW sample Sample was diluted If the sample was diluted prior to testing,
value flag. inappropriately prior to testing. repeat testing on the sample undiluted. If
the sample was generated using a diluted
assay format (for example, Diluted Beta
Human Chorionic Gonadotropin), repeat
the sample in the standard assay format (for
the example, Total Beta Human Chorionic
Gonadotropin assay).

Improper sample handling. Obtain a new sample and retest.


Guidelines for maximum amount
of time or temperature in storage
not observed.

Increased assay System not operating within Run System Check procedure and if results
variability/poor expected ranges. are not within expected ranges, refer to
precision. Section 5.2, System Check Troubleshooting.

Wrong reagent pack loaded or Verify the location of all on-board reagent
reagent pack placed in wrong packs by unloading each, checking that the
position on reagent carousel. reagent pack code on the screen matches
that on the label and reloading the reagent
pack. If the reagent pack is on-board but is
not presented during this process, call
Technical Support for assistance.

An unexpected Reagent pack expired. Check Unload expired reagent pack, load new
shift in assay reagent pack expiration date in the reagent pack, then repeat test(s).
results. Reagent Inventory screen.

Assay calibration expired. Check Recalibrate assay, then repeat test(s).


calibration expiration date in the
Reagent Inventory screen.

Preventive maintenance or repair Recalibrate assay, then repeat test(s).


has been performed since last
calibration.

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Access Reference Manual Rev 101740L 5-31
Assay Troubleshooting

Patient Sample Problems (continued)


Symptom Possible Causes/Description Corrective Action

An unexpected Contaminated wash buffer. Replace wash buffer supply with new
shift in assay buffer, prime the dispense probes by
results pressing [F6] Maint. from the Main Menu,
(continued). [F4] Fluidics Priming, then
[F2] Dispense Probes. Repeat test(s).

UNR Fatal Flag The measured sample signal 1. Review the Event Log for error events
(RLU) is less than an RLU with a similar date and time to this
threshold limit for the least event .
concentrated calibrator/ • If events occurred, troubleshoot.
calibration control for a positive
slope assay, or is greater than the 2. Run controls, then repeat the test.
least concentrated calibrator for a • If the controls are not in range,
negative slope assay, as defined in troubleshoot according to the Quality
the assay protocol file. Control Problems information.
• If you have questions about the result,
or if the problem persists, call Technical
support.

IND Fatal Flag For competitive assays only, at the 1. Review the Event Log for error events
high dose end of the curve. The with a similar date and time to this
measured sample signal (RLU) is event.
so low that the result cannot be
• If events occurred, troubleshoot.
distinguished from a system
failure. 2. Run controls, then repeat the test.
• If the controls are not in range,
troubleshoot according to the Quality
Control Problems information .
• If you have questions about the result,
or if the problem persists, call Technical
Support.

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System Support Procedures

6
System Support Procedures
• Introduction (Section 6.1)............................................................................. 6-2

• Substrate Decontamination (Section 6.2) ................................................... 6-3

• Precision Pump Seal Replacement (Section 6.3) ....................................... 6-8

• System Priming (Section 6.4) ..................................................................... 6-13

• Archiving Data To Disk (Section 6.5) ....................................................... 6-16

• System Reboot (Section 6.6) ....................................................................... 6-18

• System Check Support Information (Section 6.7)................................... 6-21

• Volume Checks (Section 6.8) ..................................................................... 6-31

• Opening and Closing the Top Cover (Section 6.9) ................................. 6-49

• Peristaltic Waste Pump Tubing Replacement (Section 6.10) ................ 6-53

• System Shut Down and Restart (Section 6.11) ........................................ 6-57

• Establishing Control Ranges (Section 6.12) ............................................. 6-63

• Special Clean Procedure (Section 6.13) .................................................... 6-66

• Incubator Belt Procedures (Section 6.14) ................................................. 6-69

• Main Pipettor Procedures (Section 6.15).................................................. 6-79

• Replacing the Waste Filter Bottle (Section 6.16) ..................................... 6-85

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 6-1
Introduction

6.1
Introduction

This chapter contains system support procedures for the Access Immunoassay
System performed to isolate or correct a system problem. Many of these
procedures should be performed only when instructed by a technical support
representative. In these cases, a caution is included in the introductory section of
the procedure.

Other cautions included in a number of procedures relate to cancelling a


maintenance procedure:

CAUTIONS
• Unless you have an emergency problem with the instrument, do not
press [F8] Cancel to stop a maintenance procedure. Cancelling the
procedure may cause damage to the instrument and may compromise the
integrity of results for subsequent tests.
• If you have an emergency problem with the instrument while a
maintenance procedure is running, press [F8] Cancel, but do not initialize
the system. Call Technical Support for assistance.

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6-2 Rev 101740L Access Reference Manual
Substrate Decontamination

6.2
Substrate Decontamination

CAUTION
This procedure should be performed only when instructed by a technical
support representative.

This section describes the substrate decontamination procedure for Access


Systems with either revision A or B fluidics. Refer to Section 1.2, Instrument
Description, in this manual to determine if your system has revision A or B
fluidics.

If contamination occurs, all system components that come into direct contact with
substrate solution must be decontaminated. Symptoms of substrate system
contamination include the following:
• High Substrate Check values (> 9000 RLUs) in System Check procedure
(refer to Chapter 8, Routine Maintenance, of the Operator’s Guide).
• Increase in zero calibrator RLUs for sandwich assays.
• Increased variability of results, especially low signal calibrators.

Possible contaminants include the following:


• Bacteria
• Oils from fingers
• Talc from gloves
• Alkaline phosphatase
• Wash buffer
• Metal ions
• Dust
• Contrad 70 cleaning solution, from unsuccessful decontamination

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Access Reference Manual Rev 101740L 6-3
Substrate Decontamination

Items • Contrad 70 cleaning solution


Required • Small container (for the diluted Contrad 70 solution)
• Pipette for measuring 2 mL and 8 mL
• Deionized water
• New, unopened bottle of substrate

NOTE
The substrate used in this procedure must be equilibrated to room temperature
for the time specified in the product insert before you load it on the analyzer.
Refer to the product insert for detailed information.

• Supply of lint-free cloth/tissue


• Rubber gloves (without talc)

Procedure
CAUTIONS
• Unless you have an emergency problem with the instrument, do not
press [F8] Cancel to stop a maintenance procedure. Cancelling the
procedure may cause damage to the instrument and may compromise the
integrity of results for subsequent tests.
• If you have an emergency problem with the instrument while a
maintenance procedure is running, press [F8] Cancel, but do not initialize
the system. Call Technical Support for assistance.
• Some steps in this procedure vary, depending on which revision of the
fluidics module is installed. Refer to Section 1.2, Instrument Description
in this manual to determine if your system has revision A or B fluidics.

WARNING
Contrad 70 cleaning solution is alkaline and may cause severe eye irritation or
mild skin irritation. Refer to the manufacturer's label for details.

1 Prepare 10 mL of a 1/5 dilution of Contrad 70 cleaning solution by adding


2 mL of Contrad 70 solution to 8 mL of deionized water in a small container.

2 Press [F6] Maint. from the Main Menu.

3 Press [F4] Fluidics Priming.

4 Change the number of priming cycles for the substrate to 1.

Use the [Arrow] keys to move the cursor to the Substrate field and type 1.

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6-4 Rev 101740L Access Reference Manual
Substrate Decontamination

5 Put on the rubber gloves (without talc).

6 Saturate a lint-free cloth or tissue with Contrad 70 cleaning solution.

7 Remove the cap and tubing from the substrate container and thoroughly
wipe down the surfaces of the substrate cap that are exposed to the substrate
and the exterior of the draw tube with the lint-free cloth saturated with
Contrad 70 cleaning solution.

Refer to Section 2.6, Substrate of the Operator’s Guide for detailed instructions
on removing the substrate.

NOTE
To avoid contaminating the substrate again, do not touch the supply line
or inside of the substrate cap, or allow the supply line to come in contact
with any surface.

8 Press [F3] Substrate to begin the priming cycle and then wait for the cycle to
complete, which will create an air gap in the substrate fluid tubing.

CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.

9 Place the substrate tubing into the container of diluted Contrad 70 cleaning
solution.

10 Change the number of substrate priming cycles to 7, then press


[F3] Substrate to begin priming.

CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.

11 Wait before proceeding to the next steps as follows:

Rev B Fluidics Rev A Fluidics


Wait Time 15-30 min 5 min

Table 6-1 Substrate Decontamination Wait Times

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Access Reference Manual Rev 101740L 6-5
Substrate Decontamination

12 Remove the tubing from the container of diluted Contrad 70 cleaning


solution and wipe it dry with a clean, dry, lint-free tissue.

NOTE
To avoid contaminating the substrate again, do not touch the supply line
or inside of the substrate cap, or allow the supply line to come in contact
with any surface.

13 Change the number of substrate priming cycles to 1 and press


[F3] Substrate.

CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.

Allow completion of the entire priming cycle to create a sufficient air gap in
the tubing.

14 Load a new bottle of substrate using the Supplies screen. However, do NOT
prime the substrate after loading the new bottle, because you prime it later
in this procedure.

Refer to Section 2.6, Substrate of the Operator’s Guide for detailed instructions
on replacing the substrate. Key sequence from the Main Menu:
[F3] Supplies, [F5] Substrate, load bottle, [F1] Done, respond YES to
Substrate bottle replaced? (i.e., highlight YES, then press [Enter]), respond
NO to Prime Substrate? (i.e., highlight NO, then press [Enter]).

15 Return to the Fluidics Priming screen.

Key sequence from the Supplies screen: [F9] Main Menu, [F6] Maint.,
[F4] Fluidics Priming.

16 Change the number of substrate priming cycles as follows and press


[F3] Substrate:

Rev B Fluidics Rev A Fluidics


Priming Cycles 15 26

Table 6-2 Substrate Decontamination 1st Time Priming Cycles

CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.

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Substrate Decontamination

17 Wait 15-20 minutes before proceeding to the next step.

18 Change the number of substrate priming cycles as follows and press [F3]
Substrate:

Rev B Fluidics Rev A Fluidics


Priming Cycles 4 (default) 10 (default)

Table 6-3 Substrate Decontamination 2nd Time Priming Cycles

CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 6-7
Precision Pump Seal Replacement

6.3
Precision Pump Seal
Replacement

CAUTION
This procedure should be performed only when instructed by a technical
support representative.

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.

This section describes the procedure for replacing the piston seals on the precision
pump of a system with revision A fluidics. A technical support representative will
replace your precision pump seals if your system has revision B fluidics. If fluid is
leaking from the precision pump, there may be deposits around the exterior of the
pump and the seal may need to be replaced.

Items • Replacement top and bottom seals (do not remove seals from their
Required individual bags until ready to use)
• Phillips screwdriver
• Flat-blade screwdriver
• Hemostat
• Clean, lint-free cloth
• Deionized water

Procedure 1 Press [F7] Diag. from the Main Menu.

The Diagnostics screen is displayed.

2 Press [F2] Mechanics.

The Mechanics screen is displayed.

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Precision Pump Seal Replacement

3 Press [F1] Select Primary Device to display a menu of options.

4 Use the [Arrow] keys to highlight Precision Pump, then press [Enter].
Precision Pump is displayed in the Primary Device field, the current pump
piston position is displayed in the Current Position field, and 4 piston
position options are displayed in the middle section of the screen.

5 Press [F2] Home Device.

6 Open the front panel of the analyzer to expose the precision pump, which is
located behind the smoked plastic window on the front panel.

Upper Piston Housing

Lower Piston
Upper Piston Lower Piston Housing

Top Seal

Pump Barrel
Mounting Block

Bottom Seal

Figure 6-4 Precision Pump

7 Unscrew the top fluid fitting from the mounting block on the right side of
the pump barrel. (The fittings connect the fluid lines from the precision
valve to the precision pump.) Do not remove the fitting from the fluid line,
or the fluid line from the precision valve.

8 Unscrew the bottom fluid fitting from the mounting block. Do not remove
the fitting from the fluid line, or the fluid line from the precision valve.

9 Use the [Tab] key to highlight the Low Res. Max. option, then press
[F3] Move to Position.

10 While holding the upper piston housing down with 1 hand, use a small
Phillips screw driver to remove the 2 screws securing the upper piston

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Access Reference Manual Rev 101740L 6-9
Precision Pump Seal Replacement

housing to the analyzer. Place the screws and washers in a safe place. When
both screws are removed, the upper piston housing tends to spring upward.
Gently allow the housing to move upward.

11 Hold the pump barrel stationary and carefully pull straight up on the upper
piston housing to separate the upper piston housing from the pump barrel.
Set the upper piston housing aside with the piston extending upward.

12 Wrap a lint-free cloth around the lower piston housing to absorb any fluid
remaining in the pump, then carefully pull straight up on the pump barrel
to separate the pump barrel from the lower piston.

13 Press upward on the bottom of the brown plastic piston flange (supporting
the lower piston) to remove it from the lower piston assembly. Wipe the
flange with a clean, lint-free cloth moistened with deionized water to
remove any deposits.

CAUTION
Remove the seals carefully in the following steps to ensure that the pump
barrel is not scratched or scored. Should this occur, call Technical Support for
assistance.

14 Remove the top and bottom seals from the pump barrel by gently lifting the
inner edge of the seal (away from the pump barrel wall) using a hemostat or
your fingernail or a small flat-blade screw driver until the seal is completely
free from the barrel. If using a screw driver, do not allow the screw driver
to come in contact with the inside of the pump barrel.

15 Rinse the pump barrel with deionized water, then shake the barrel to
remove any excess water. Dry the area where the upper and lower seals seat
with a lint-free cloth.

16 Using a damp, lint-free cloth, wipe the upper piston, upper piston housing,
lower piston, and outside of the pump barrel to remove any deposits.

17 Remove the new top seal from the plastic bag. Do not remove both seals at
the same time because they are difficult to differentiate. Place the new top
seal, with the spring side down, on a flat surface such as a table top.

18 Align the top of the barrel (the fluid fitting mounting block is nearest the top)
with the seal and press down until the barrel contacts the table top.

19 Turn the barrel upright (with the seal inside) and use your finger to press the
seal completely down into the barrel until you feel the seal snap into place.

20 Repeat steps 17 through 19 using the bottom seal and the bottom of the
pump barrel.

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6-10 Rev 101740L Access Reference Manual
Precision Pump Seal Replacement

21 Slide the top of the brown plastic piston flange over the top of the lower
piston, then press down firmly until it is completely seated in the metal
support bracket on the analyzer.

22 Slide the barrel and upper piston housing (with the fluid fitting mounting
block to the right), down onto the lower piston housing (the lower piston
housing is still connected to the analyzer). Press firmly to seat the pump
barrel onto the lower piston housing.

23 Align the upper piston with the top seal in the pump barrel, ensuring that
the fluid fitting mounting block is on the top and to the right and that the
piston will enter the seal squarely. Slide the upper piston completely into the
barrel. Press firmly to seat the upper piston housing onto the top of the
barrel and hold it in place with 1 hand.

24 Insert and tighten each Phillips screw into the upper piston housing. Push
down on the upper piston housing to align the screws with the screw
positioning holes on the analyzer.

NOTE
If you cannot align the screws with the holes in the analyzer, turn the brown
knurled (scored) portion of the upper piston housing from left to right until the
screws and the screw positioning holes are aligned (approximately 1/2 to 1 turn).
If the problem persists, call Technical Support for assistance.

25 Using only your fingers, turn but do not force, the knurled (scored) portion
of the upper piston housing from right to left to tighten the upper piston
housing down onto the pump barrel. The assembly should be snug enough
that the barrel resists movement, but can still be manually rotated.

CAUTION
DO NOT over-tighten the fluid fittings in the following steps. Gently tighten
the fluid fittings using only your fingers.

26 Locate the fluid line coming off the lower left fitting of the precision valve.
Gently screw the fluid fitting on the “loose” end of the fluid line into the
bottom opening of the mounting block on the right side of the precision
pump barrel.

27 Locate the fluid line coming off the upper left fitting of the precision valve.
Gently screw the fluid fitting on the “loose” end of the fluid line into the top
opening of the mounting block on the right side of the precision pump
barrel.

28 Close the top cover and front panel of the analyzer.

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Access Reference Manual Rev 101740L 6-11
Precision Pump Seal Replacement

29 To verify that the precision pump is operating properly, ensure that


Precision Pump is displayed in the Primary Device field, then press
[F2] Home Device.

30 When the homing process is complete, press [Esc] to return to the


Diagnostics screen.

31 Ensure that the front panel and top cover are closed, then press
[F1] System Init.

32 When the system initialization process is complete, press [F9] Main Menu.

33 Press [F6] Maintenance.

34 Press [F4] Fluidics Priming.

35 Press [F1] Pipettor. Four priming cycles are performed. Watch through the
plastic window on the front panel to ensure that all air is removed from the
precision pump during priming. If you see bubbles, repeat the priming.

36 When priming is complete, open the front panel and check for fluid leaking
from the fittings and for air bubbles in the pump or the main pipettor.

• If you see fluid leaks or air bubbles, call Technical Support.

• If you do not see fluid leaks or air bubbles, close the front panel.

Verification 37 Run the System Check procedure (refer to Section 8.4, Weekly Maintenance
of the Operator’s Guide). Troubleshoot if results are not within expected
ranges (refer to Section 5.2, System Check Troubleshooting).

NOTE
After successfully completing a precision pump seal replacement, Beckman
Coulter recommends that you:
• Run quality control samples for all assays you are using to report patient
results.
• Recalibrate any assay with out-of-range results.

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6-12 Rev 101740L Access Reference Manual
System Priming

6.4
System Priming
This section describes the procedure for priming various components of the
Access System. The following components can be primed individually or
simultaneously:
• Main pipettor
• Dispense probes
• Substrate

The number of priming cycles can be selected for each component. The default
setting is recommended unless otherwise specified by a procedure in an Access
manual or by Technical Support.

CAUTIONS
• Unless you have an emergency problem with the instrument, do not
press [F8] Cancel to stop a maintenance procedure. Cancelling the
procedure may cause damage to the instrument and may compromise the
integrity of results for subsequent tests.
• If you have an emergency problem with the instrument while a
maintenance procedure is running, press [F8] Cancel, but do not initialize
the system. Call Technical Support for assistance.

Priming Main 1 Press [F6] Maint. from the Main Menu.


Pipettor
The Maintenance screen is displayed.

2 Press [F4] Fluidics Priming.

The Fluidics Priming screen is displayed with the cursor in the No. Cycles
field for the pipettor.

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Access Reference Manual Rev 101740L 6-13
System Priming

• To change the number of cycles from the default, type the desired number
of cycles.

3 Press [F1] Pipettor.

CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.

The main pipettor is primed. The Pipettor Priming screen is displayed while
priming is in process.

Priming 1 Press [F6] Maint. from the Main Menu.


Dispense
The Maintenance screen is displayed.
Probes
2 Press [F4] Fluidics Priming.

The Fluidics Priming screen is displayed with the cursor in the No. Cycles
field for the pipettor.

• To change the number of cycles from the default, use the [Arrow] keys to
move the cursor to the No. Cycles field for dispense probes, then type the
desired number of cycles.

3 Press [F2] Dispense Probes.

CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.

The dispense probes are primed. The Dispense Probes screen is displayed
while priming is in process.

Priming 1 Press [F6] Maint. from the Main Menu.


Substrate
The Maintenance screen is displayed.

2 Press [F4] Fluidics Priming.

The Fluidics Priming screen is displayed with the cursor in the No. Cycles
field for the pipettor.

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6-14 Rev 101740L Access Reference Manual
System Priming

• To change the number of cycles from the default, use the [Arrow] keys to
move the cursor to the No. Cycles field for substrate, then type the desired
number of cycles.

3 Press [F3] Substrate.

CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.

The substrate is primed. The Substrate screen is displayed while priming is


in process.

Priming All 1 Press [F6] Maint. from the Main Menu.


System
The Maintenance screen is displayed.
Components
2 Press [F4] Fluidics Priming.

The Fluidics Priming screen is displayed with the cursor in the No. Cycles
field for the pipettor.

• To change the number of cycles for any component, use the [Arrow] keys to
move the cursor to the No. Cycles field for that component, then type the
desired number of cycles.

3 Press [F5] All.

CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.

All system components are primed. The Prime All screen is displayed while
priming is in process.

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 6-15
Archiving Data To Disk

6.5
Archiving Data To Disk
This section describes the procedure for archiving test and system data to a
3.5” High Density disk formatted for DOS (Figure 6-5 is a flow chart of this
procedure). The archived information is then used by a technical support
representative for troubleshooting. There are 2 data archiving options:
• Expanded Archive Data archives detailed testing information in a
comma separated field format, which can then be imported into a
PC-based spreadsheet program.
• Archive Service Data archives detailed system information in the
OS9000 database format.

Test results can also be archived from the View Test Results screen. For more
information on archiving test results, refer to Chapter 5 of the Operator’s Guide.

NOTE
Archiving on the Access Immunoassay System means copying data to disk.
Archiving does not mean copying and removing data. Data is removed when the
data storage capacity is reached. Then, the oldest data is automatically removed
(overwritten) as new data is added.

Data storage capacity is whichever of the following occurs first:


• Maximum of 1000 samples or
• Maximum of 2200 test results

The maximum information that can be archived at one time is equivalent to the
data storage capacity.

NOTE
Data cannot be archived when the system is in the RUNNING or PAUSED mode.

3/00 © 2000 Copyright Beckman Coulter, Inc.


6-16 Rev 101740L Access Reference Manual
Archiving Data To Disk

Archive Data

Main Menu

[F7] Diag.

Diagnostics

[F8] More Options


[Arrow] to desired data archiving option, then [Enter]

Insert formatted disk into drive, then [Enter]

When archival is complete, remove disk from drive


[F9] Main Menu

Main Menu

Figure 6-5 Archive Data To Disk Flow Chart

Archiving 1 Press [F7] Diag. from the Main Menu.


Data
The Diagnostics screen is displayed.

2 Press [F8] More Options.

A menu of options is displayed.

3 Press the [Down Arrow] key to highlight the desired data archiving option,
then press [Enter].

4 Insert a 3.5” disk formatted for DOS into the disk drive, then press [Enter].
A message informs you when the archival process is complete.

• If you are prompted to insert additional disks, remove the current disk and
insert a new DOS formatted disk into the drive, then press [Enter].

5 Remove the disk from the drive and label it with the file number displayed
in the prompt line.

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 6-17
System Reboot

6.6
System Reboot
This section describes the various procedures for rebooting, or restarting the
system. There are 2 ways by which the system may be rebooted. The preferred
method is using the reset button and therefore, is described first.

Rebooting The system may be rebooted by pressing the reset button. This method is also
Using the called a “warm boot.”
Reset Button
1 Open the front panel of the analyzer.

2 Locate the reset button which is located just to the right of the pipettor
gantry (refer to Figure 6-6).

3 Press the reset button for 1 second and release.

Figure 6-6 Reset Button

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6-18 Rev 101740L Access Reference Manual
System Reboot

4 Close the front panel of the analyzer immediately.

NOTE
If the front panel is not closed, the system will not be able to home the
mechanical devices. Should this occur, press the reset button a second time and
then close the front panel immediately.

Several screens are displayed as the software “boots.” Do not press any keys
on the keyboard until the reboot is complete. When the Main Menu is
displayed, the system mode is NOT READY and system initialization begins.

During the system initialization, the appropriate mechanical devices are


homed and various messages may be displayed, depending on the system
status when the reset button is pressed. When the system initialization is
successfully completed, the system mode changes to READY. If the system
initialization is not successfully completed, call Technical Support.

Rebooting The system may be rebooted using the on/off switch as described below. This
Using the method is also called a “cold boot.”
On/Off Switch
1 Ensure the front panel of the analyzer is closed.

NOTE
If the front panel is not closed, the system will not be able to home the
mechanical devices. Should this occur, close the front panel, then turn the power
off and on a second time.

2 Locate the power switch on the lower, back part of the right side of the
analyzer (refer to Figure 6-7).

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Access Reference Manual Rev 101740L 6-19
System Reboot

Power Switch

Figure 6-7 Power Switch

3 Press the bottom part of the switch to turn the power off.

4 Wait approximately 20 seconds and then press the top part of the switch to
turn the power on.

Several screens are displayed as the software “boots.” Do not press any keys
on the keyboard until the reboot is complete. When the Main Menu is
displayed, the system mode is NOT READY and system initialization begins.

During the system initialization, the appropriate mechanical devices are


homed and various messages may be displayed, depending on the system
status when the power is turned off. When the system initialization is
successfully completed, the system mode changes to READY. If the system
initialization is not successfully completed, call Technical Support.

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6-20 Rev 101740L Access Reference Manual
System Check Support Information

6.7
System Check Support
Information
This section includes information about the System Check procedure, which is
performed as part of weekly maintenance and/or when troubleshooting the
system. A better understanding of this procedure may assist you in diagnosing
and fixing a problem. Refer to Section 8.4, Weekly Maintenance, of the Operator’s
Guide for instructions on performing the System Check procedure. If any of the
System Check results fail to meet the specified criteria, refer to Chapter 5,
Troubleshooting for further instructions. Troubleshooting procedures or Technical
Support may refer you to individual tests of the System Check procedure, which
are provided later in this section.

Table 6-8 correlates the part of the System Check procedure with the function or
component that is tested.

Function/Component Portion of System Check


Tested Procedure

Reaction vessel (RV) wash system Washed Check, Clean Check, Wash
(various components involved in Efficiency
washing the RVs during testing)

Substrate and substrate dispense All


system (various components used to
dispense substrate into RVs)

Main pipettor module Unwashed Check

Luminometer All

Mixing system Washed Check

Aspirate probes (and waste Washed Check, Substrate Check ratio,


components of the fluidics module) Wash Efficiency PPM

Table 6-8 System Check Procedure

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Access Reference Manual Rev 101740P 6-21
System Check Support Information

Washed Check
During the Washed Check, the main pipettor dispenses 150 mL of undiluted
System Check Solution into 10 RVs on which 3 wash cycles are then performed.
Next, 200 mL of substrate is pipetted into each RV, and the RLUs are measured
with the luminometer.

Each wash cycle should reduce the concentration of the System Check Solution by
a factor of at least 100. Therefore, the final concentration of System Check Solution
should be at least 1/1,000,000 of the original concentration. The mean RLUs for
the Washed Check should be between 5,000–20,000, and the % CV should be £ 12.
If the results are outside the acceptable limits, the performance of the RV wash
and/or mixing systems may be impaired.

Clean Check
The 5 RVs used in the Clean Check are processed similarly to the RVs for the
Washed Check. The differences are that 150 mL of wash buffer is added to the RVs
instead of the undiluted System Check Solution, and only 5 RVs are used.

These results should be examined to ensure that there is not a significant decline
in the RLUs from the first to the last replicate. This type of a decrease in the RLUs
indicates that there may be carryover occurring in the wash/read carousel due to
poor washing of the aspirate probes.

Substrate Check
In the Substrate Check, no sample (i.e., no wash buffer or System Check Solution)
is added to the RVs, and the RVs are not washed. For this test, 200 mL of substrate
is pipetted into 10 RVs, then the RLUs are measured with the luminometer.

The mean, SD, and % CV are calculated from the RLU readings on the last 6 RVs.
This is because during the Clean Check as the wash arm is lowered, the aspirate
probe touches the bottom of the first 4 Substrate Check RVs. A small amount of
residual fluid from the probe could remain in the RV and increase the RLU
reading.

The highest RLU single reading from the first 4 RVs is divided by the mean of the
RLUs measured for the last 6 RVs to obtain the substrate ratio. This ratio should
be £ 1.4. If the ratio is > 1.4, the function of the waste system could be
compromised.

The mean RLU value for the Substrate Check should be between 5,000 and 9,000
and the % CV should be £ 5. If the results are outside of the acceptable limits, the
performance of the substrate dispense system or the luminometer could be
suspect.

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6-22 Rev 101740P Access Reference Manual
System Check Support Information

Unwashed Check
The Unwashed Check is performed similarly to the Substrate Check, except that
the main pipettor dispenses 50 mL of diluted System Check Solution into 10 RVs.
The RVs are not washed, and 200 mL of substrate is added. The RLUs for the
Unwashed Check are significantly higher because of the chemical reaction
between the substrate and the System Check Solution.

The % CV should be ˆ 2. If the Substrate Check results are acceptable but the
Unwashed Check % CV results fail to meet specifications, the precision of the
main pipettor may be compromised.

Although not a system specification, the RLU mean result for the Unwashed
Check can be used as a reference guideline. If results are not in the range of
4–10 million, there may have been an error made in preparing the 1/501 dilution
of the System Check Solution. Prepare the dilution again and repeat the System
Check procedure.

Wash Efficiency
The Wash Efficiency is calculated using the results from the Washed, Substrate,
and Unwashed Checks as described below. The result prints on the System Check
Report.

1. The Unwashed RLUs per mL (RLUs/mL) is calculated as shown:

(Mean RLUs Unwashed  0.0998) = (RLUs/mL)

2. Using the result from step 1, the Unwashed RLUs per RV (RLUs/RV) is
calculated as shown:

Unwashed RLUs/mL (from step 1) x 150 = (RLUs/RV)

3. The Mean RLUs Washed reduced by the Mean RLUs Substrate is divided by
the RLUs per RV from step 2 also reduced by the Mean RLUs Substrate, as
shown in ratio form:

Mean RLUs Washed – Mean RLUs Substrate

RLUs/RV (from step 2) – Mean RLUs Substrate

4. The Wash Efficiency ppm (parts per million) is obtained by multiplying the
result from step 3 by 1,000,000.

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 6-23
System Check Support Information

If the Wash Efficiency


from Step 4 Is... Then...

ˆ 5 ppm The wash efficiency result is acceptable.

> 5 ppm The performance of the wash system may be


suspect.

NOTE
If the Wash Efficiency result is a negative number, due to either low RLUs
for the Washed Check or high RLUs for the Substrate Check, the substrate
system may be contaminated. For more information, refer to the
troubleshooting information in Chapter 5.

System Checks and Aspirate Probes


If the aspirate probes are dirty or plugged, the RVs may not completely empty
during aspiration. This could cause the performance of the waste components of
the fluidics module (i.e., waste valve and pump for revision A fluidics or
peristaltic waste pump for revision B fluidics) to be impaired. In these situations,
the RLUs may be falsely elevated, which may result in failed results for the
washed, substrate ratio, and/or PPM wash efficiency portions of the System
Check procedure.

Individual Following is a description of how to run each of the 3 tests that comprise the
System System Check procedure. Each of the tests can be performed alone to pinpoint
Checks problems indicated by failed System Check results:
• Washed Check
• Substrate Check
• Unwashed Check

You may be instructed to perform 1 or more of these tests individually as part of


troubleshooting.

NOTES
• To obtain the Wash Efficiency result, you must run the complete System
Check procedure described in Section 8.4, Weekly Maintenance in the
Operator’s Guide.
• Use only 2.0 mL sample cups for the System Check tests.

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6-24 Rev 101740L Access Reference Manual
System Check Support Information

CAUTIONS
• Unless you have an emergency problem with the instrument, do not
press [F8] Cancel to stop a maintenance procedure. Cancelling the
procedure may cause damage to the instrument and may compromise the
integrity of results for subsequent tests.
• If you have an emergency problem with the instrument while a
maintenance procedure is running, press [F8] Cancel, but do not initialize
the system. Call Technical Support for assistance.

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.

Running 1 Press [F6] Maint. from the Main Menu.


Washed The Maintenance screen is displayed.
Check
Individually 2 Prepare the maintenance tray. Fill a sample cup completely (2.0 mL) with
undiluted System Check Solution and place the cup in sample position 1.
The sample cup will be full, but the solution level should not be higher
than the top of the cup.

NOTE
The tray preparation instructions (step 2) assume that the default of 10
replicates is used (a minimum of 10 replicates must be performed to assure
statistically valid results). If the number of replicates is increased, add 1
sample cup with 2 mL of undiluted System Check Solution for each 10
replicates and place the sample cups in sequential positions on the tray
(maximum of 10 replicates per sample cup). For example, if running 25
replicates, fill 3 sample cups with solution and place the cups in sample
positions 1, 2, and 3.

3 Press [F1] Load/Unload Tray.


The Load Maintenance Tray screen is displayed with the cursor in the Tray
ID field.

4 Enter the Tray ID for the maintenance tray.

5 Load the tray onto the system, then press [F1] Done and [Enter] to confirm
that the maintenance tray is loaded.

The Maintenance screen is displayed. Refer to Section 4.3, Sample Trays of


the Operator’s Guide for instructions on placing a tray onto the sample
carousel.

© 2003 Beckman Coulter, Inc. 5/03


Access Reference Manual Rev 101740S 6-25
System Check Support Information

6 Press [F3] System Checks.

The System Checks screen is displayed.

7 Press [F2] Washed.

The Washed Check screen is displayed.

• To change the number of replicates to be run, press the [Tab] key to move
the cursor to the No. Reps field, type the desired number of replicates, then
press [Enter].

8 Press [F1] Start Test.

CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.

The testing results are displayed as the samples are processed.

When testing is complete, the washed system check report will


automatically print and an automatic probe clean will be performed.

9 Compare the obtained results with the expected results listed in Table 6-9. If
the results are outside the acceptable limits, contact Technical Support.

Expected % CV ˆ12%
Expected RLU Mean 5,000–20,000

Table 6-9 Washed Check Expected Results

10 Press [Esc] to display the System Checks screen.

11 Press [Esc] to display the Maintenance screen.

12 Press [F1] Load/Unload Tray.

NOTE
The maintenance tray must be unloaded before patient samples, quality
control samples, calibrators, or calibration controls can be processed.

13 Unload the maintenance tray, then press [F1] Done and [Enter] to confirm
that the maintenance tray is unloaded.

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6-26 Rev 101740L Access Reference Manual
System Check Support Information

Running 1 Press [F6] Maint. from the Main Menu.


Substrate
The Maintenance screen is displayed.
Check
Individually 2 Prepare the maintenance tray. Place an empty sample cup in position 1.

NOTE
The tray preparation instructions (step 2) assume that the default of 10
replicates is used. If the number of replicates is increased, add another
empty sample cup for each 10 replicates and place the sample cups in
sequential positions on the tray (maximum of 10 replicates per sample
cup). For example, if running 25 replicates, place 3 empty sample cups in
sample positions 1, 2, and 3.

3 Press [F1] Load/Unload Tray.

The Load Maintenance Tray screen is displayed with the cursor in the Tray
ID field.

4 Enter the Tray ID for the maintenance tray.

5 Load the tray onto the system, then press [F1] Done and [Enter] to confirm
that the maintenance tray is loaded.

The Maintenance screen is displayed. Refer to Section 4.3, Sample Trays of


the Operator’s Guide for instructions on placing a tray onto the sample
carousel.

6 Press [F3] System Checks.

The System Checks screen is displayed.

7 Press [F3] Substrate.

The Substrate Check screen is displayed.

• To change the number of replicates to be run, press the [Right Arrow] key
to move the cursor to the No. Reps field, type the desired number of
replicates, then press [Enter].

8 Press [F1] Start Test.

CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.

The testing results are displayed as the samples are processed.

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 6-27
System Check Support Information

When testing is complete, the substrate system check report will


automatically print and an automatic probe clean will be performed.

9 Compare the obtained results with the expected results listed in Table 6-10.
If the results are outside the acceptable limits, contact Technical Support for
assistance.

Expected % CV ˆ 5%
Expected RLU Mean 5,000–9,000

Table 6-10 Substrate Check Expected Results

10 Press [Esc] to display the System Checks screen.

11 Press [Esc] to display the Maintenance screen.

12 Press [F1] Load/Unload Tray.

NOTE
The maintenance tray must be unloaded before patient samples, quality
control samples, calibrators, or calibration controls can be processed.

13 Unload the maintenance tray, then press [F1] Done and [Enter] to confirm
that the maintenance tray is unloaded.

Running 1 Press [F6] Maint. from the Main Menu.


Unwashed
The Maintenance screen is displayed.
Check
Individually 2 Prepare a 1/501 dilution of System Check Solution. Mix 20 mL System Check
Solution with 10 mL of wash buffer.

3 Prepare the maintenance tray. Pipette at least 1 mL of the 1/501 diluted


System Check Solution into a sample cup and place the cup in sample
position 1.

NOTE
The tray preparation instructions (step 3) assume that the default of 10
replicates is used (a minimum of 10 replicates must be performed to assure
statistically valid results). If the number of replicates is increased, add 1
sample cup with 2 mL of diluted System Check Solution for each 10
replicates and place the sample cups in sequential positions on the tray

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6-28 Rev 101740L Access Reference Manual
System Check Support Information

(maximum of 10 replicates per sample cup). For example, if running 25


replicates, fill 3 sample cups with solution and place the cups in sample
positions 1, 2, and 3.

4 Press [F1] Load/Unload Tray.

The Load Maintenance Tray screen is displayed with the cursor in the Tray
ID field.

5 Enter the Tray ID for the maintenance tray.

6 Load the tray onto the system, then press [F1] Done and [Enter] to confirm
that the maintenance tray is loaded.

The Maintenance screen is displayed. Refer to Section 4.3, Sample Trays of


the Operator’s Guide for instructions on placing a tray onto the sample
carousel.

7 Press [F3] System Checks.

The System Checks screen is displayed.

8 Press [F4] Unwashed.

The Unwashed Check screen is displayed.

• To change the number of replicates to be run, press the [Right Arrow] key
to move the cursor to the No. Reps field, type the desired number of
replicates, then press [Enter].

9 Press [F1] Start Test.

CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.

The testing results are displayed as the samples are processed.

When testing is complete, the unwashed system check report will


automatically print and an automatic probe clean will be performed.

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 6-29
System Check Support Information

10 Compare the obtained results with the expected results listed in Table 6-11.
If the results are outside the acceptable limits, contact Technical Support for
assistance.

Expected % CV ˆ 2%
Expected RLU Mean 4-10 million *

Table 6-11 Unwashed Check Expected Results


*Although not a system specification, the RLU mean result for the
Unwashed Check can be used as a reference guideline. If results are not in
the range of 4–10 million, try preparing the 1/501 dilution of System Check
Solution again and repeating the System Check procedure.

11 Press [Esc] to display the System Checks screen.

12 Press [Esc] to display the Maintenance screen.

13 Press [F1] Load/Unload Tray.

NOTE
The maintenance tray must be unloaded before patient samples, quality
control samples, calibrators, or calibration controls can be processed.

14 Unload the maintenance tray, then press [F1] Done and [Enter] to confirm
that the maintenance tray is loaded.

3/00 © 2000 Copyright Beckman Coulter, Inc.


6-30 Rev 101740L Access Reference Manual
Volume Checks

6.8
Volume Checks

This section describes how to perform volume check tests on the Access System.
These tests require external measurement by the operator and are designed to
quantitatively measure the dispense precision and accuracy of the various parts
of the fluidic module using gravimetric measurements. However, qualitative
assessment of the performance is also possible by visual examination. Procedures
for visual volume checks are included after the analytical volume check
procedures.

Due to the small volumes used by the Access System, an analytical balance is
required for most gravimetric measurements. Discrimination to the nearest
hundredth of a milligram (0.01 mg) is recommended for optimal performance.
When handling and weighing reaction vessels:
• Wear gloves to prevent transferring oils onto the vessels.
• Use forceps to remove the vessels from the instrument and balance.
• Weigh vessels immediately after dispensing to minimize evaporation.
• Take at least 9 replicates of the measurements to obtain a meaningful
representation of the system precision and accuracy.
• Number the vessels before weighing to ensure correct sequences.

You may be instructed to perform 1 or more of the volume check tests as part of
troubleshooting.

CAUTIONS
• Unless you have an emergency problem with the instrument, do not
press [F8] Cancel to stop a maintenance procedure. Cancelling the
procedure may cause damage to the instrument and may compromise the
integrity of results for subsequent tests.
• If you have an emergency problem with the instrument while a
maintenance procedure is running, press [F8] Cancel, but do not initialize
the system. Call Technical Support for assistance.

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 6-31
Volume Checks

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

1 Press [F6] Maint. from the Main Menu.


The Maintenance screen is displayed.

2 Press [F3] System Checks.


The System Checks screen is displayed.

3 Press [F6] Volume.


The Volume Checks screen is displayed.

4 Press [F1] Substrate.


The Substrate Volume screen is displayed.

5 Open the front panel of the instrument.

6 Remove the reaction vessels in positions 1, 2, and 3 in the RV shuttle (refer


to Figure 6-12).

Position 2
Position 3 Position 1

To reaction
vessel
waste bag

Figure 6-12 RV Shuttle Positions


7 Number the vessels.

8 Weigh the vessels using an analytical balance, and record the weights.

NOTE
After weighing the reaction vessels, handle them with the forceps, not with
your hands.

9 Place the 3 weighed reaction vessels into the vacated shuttle positions.

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6-32 Rev 101740S Access Reference Manual
Volume Checks

10 Close the front panel of the instrument, then press [F1] Done.

CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.

The substrate is dispensed and the reaction vessels are returned to shuttle
positions 1, 2, and 3.

11 Open the front panel of the instrument.

12 Using the forceps, remove the reaction vessels.

13 Close the front panel of the instrument, then press [Enter].

The shuttle advances 3 positions.

14 Weigh the reaction vessels using the analytical balance, and record the
weights.

15 Repeat steps 5 - 14 for the desired number of replicates.

16 Convert vessel weight to volume using the equation in Table 6-13, then
calculate the mean, standard deviation, and % CV of the replicates.

Volume = weight / density

mL = mg / 1.006 mg/mL (substrate density)

Table 6-13 Substrate Weight-to-Volume Conversion

17 Compare the obtained results with the expected results listed in Table 6-14.
If the results are outside the acceptable limits, contact Technical Support for
assistance.

Target Volume 200 mL

Expected Volume Range 194 - 206 mL

Expected % CV ˆ 2%
Table 6-14 Substrate Volume Expected Results

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Volume Checks

Running The visual volume check is used to detect gross volume errors.
Visual
Substrate WARNING
Volume
You will come in contact with potentially infectious materials during this
Check procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.

1 Press [F6] Maint. from the Main Menu.


The Maintenance screen is displayed.

2 Press [F3] System Checks.


The System Checks screen is displayed.

3 Press [F6] Volume.


The Volume Checks screen is displayed.

4 Press [F1] Substrate.


The Substrate Volume screen is displayed.

NOTE
A message is displayed prompting you to remove and weigh 3 RVs. For
this procedure, you do NOT have to perform this step.

5 Press [F1] Done.

CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.

The substrate is dispensed and the reaction vessels are returned to the
shuttle.

6 Open the front panel of the instrument.

7 Using the forceps, remove the reaction vessels from shuttle positions 1, 2,
and 3 (refer to Figure 6-12).

8 Close the front panel of the instrument, then press [Enter].


The shuttle advances 3 positions.

9 Manually pipette 200 mL of substrate or wash buffer into an empty reaction


vessel.
This vessel will be used as a reference for comparison to the 3 reaction
vessels removed from the shuttle.

10 Place the reference vessel and the 3 dispensed vessels on a level surface.

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11 Visually compare the volumes.

The 3 reaction vessels should have equal volumes of substrate, or the


difference between any 2 should be no greater than 1/2 of the meniscus
height.

The amount of substrate in the 3 reaction vessels should be within 1


meniscus height of the amount of substrate or wash buffer in the manually
pipetted reaction vessel.

NOTE
Only gross volume discrepancies will be visible.

• If you see a significant volume difference in any of the vessels, call Technical
Support.

12 Inspect the dispensed vessels for air bubbles. Proper substrate dispense will
leave no bubbles on the surface, or sometimes a few small, regularly sized
bubbles around the surface edge.

• If you see large, irregularly sized, or an excessive amount of bubbles in any


of the vessels:
- Prime the substrate (refer to Section 6.4, System Priming for
instructions).
- Repeat the visual volume check.
- If air bubbles continue, call Technical Support.

Running The procedure for running a 50 mL pipettor volume check is the same as that for
Analytical running both 200 and 350 mL volume checks, except for the volume selected.
Main Pipettor
Volume WARNING
Checks (50/
200/350 mL) 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 Press [F6] Maint. from the Main Menu.

The Maintenance screen is displayed.

2 Prepare the maintenance tray as follows:

• Pipette at least 1.5 mL of wash buffer into a sample cup and place the cup
in sample position 1.

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Volume Checks

NOTE
When performing repeated dispense checks, verify that the sample cup
contains sufficient volume to complete the 3 aspirations. For the 200 and
350 mL volumes, it is recommended that you remove and refill the sample cup
after each group of 3 vessels.

3 Press [F1] Load/Unload Tray.

The Load Maintenance Tray screen is displayed with the cursor in the Tray
ID field.

4 Enter the Tray ID for the maintenance tray.

5 Load the tray onto the system, then press [F1] Done and [Enter] to confirm
that the maintenance tray is loaded.

The Maintenance screen is displayed. Refer to Section 4.3, Sample Trays in


the Operator’s Guide for detailed instructions on placing a tray onto the
sample carousel.

6 Press [F3] System Checks.

The System Checks screen is displayed.

7 Press [F6] Volume.

The Volume Checks screen is displayed.

8 Press [F2] Pipettor 50 mL, [F3] Pipettor 200 mL, or [F8] Low Res. Dispense
350 mL.

The appropriate Pipettor Volume screen is displayed.

9 Open the front panel of the instrument.

10 Remove the reaction vessels in positions 1, 2, and 3 in the RV shuttle (refer


to Figure 6-12).

11 Number the vessels.

12 Weigh the vessels using an analytical balance, and record the weights.

NOTE
After weighing the reaction vessels, handle them with the forceps, not with
your hands.

13 Place the 3 weighed reaction vessels into the vacated shuttle positions.

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14 Close the front panel of the instrument, then press [F1] Done.

CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.

The wash buffer is dispensed and the reaction vessels are returned to shuttle
positions 1, 2, and 3.

15 Open the front panel of the instrument.

16 Using the forceps, remove the reaction vessels.

17 Close the front panel of the instrument, then press [Enter].

The shuttle advances 3 positions.

18 Weigh the reaction vessels using the analytical balance, and record the
weights.

19 Repeat steps 9 - 18 for the desired number of replicates.

NOTE
Be sure that the sample cup contains sufficient wash buffer to complete the
aspirations.

20 Convert vessel weight to volume using the equation in Table 6-15, then
calculate the mean, standard deviation, and % CV of the replicates.

Volume = weight / density

mL = mg / 1.007 mg/mL (wash buffer density)

Table 6-15 Pipettor Weight-to-Volume Conversion

21 Compare the obtained results with the expected results listed in Table 6-16.
If the results are outside the acceptable limits, contact Technical Support for
assistance.

Target Volume - Pipettor 50 mL

Expected Volume Range 47.5 - 52.5 mL

Expected % CV ˆ 2%
Table 6-16 Pipettor Volume Expected Results

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Volume Checks

Target Volume - Pipettor 200 mL

Expected Volume Range 190 - 210 mL

Expected % CV £ 1%
Target Volume - Low Res. Dispense 350 mL

Expected Volume Range 332.5 - 367.5 mL

Expected % CV £ 1%
Table 6-16 Pipettor Volume Expected Results (continued)

22 When you are done with this procedure, press [Esc] twice to return to the
Maintenance screen.

23 Press [F1] Load/Unload Tray.


The Unload Maintenance Tray screen is displayed.

24 When the maintenance tray is presented, unload the tray.

25 Press [F1] Done and then [Enter] to confirm that the maintenance tray is off-
board.

Running The visual volume check is used to detect gross volume errors.
Visual Main
Pipettor WARNING
Volume
You will come in contact with potentially infectious materials during this
Checks (50/ procedure. Handle and dispose of biohazard materials according to proper
200/350 mL) laboratory procedures. Proper hand, eye, and facial protection is required.

1 Press [F6] Maint. from the Main Menu.


The Maintenance screen is displayed.

2 Prepare the maintenance tray as follows:


• Pipette at least 1.5 mL of wash buffer into a sample cup and place the cup
in sample position 1.

NOTE
When performing repeated dispense checks, verify that the sample cup
contains sufficient volume to complete the 3 aspirations. For the 200 and
350 mL volumes, it is recommended that you remove and refill the
sample cup after each group of 3 vessels.

3 Press [F1] Load/Unload Tray.


The Load Maintenance Tray screen is displayed with the cursor in the Tray
ID field.

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Volume Checks

4 Enter the Tray ID for the maintenance tray.

5 Load the tray onto the system, then press [F1] Done and [Enter] to confirm
that the maintenance tray is loaded.

The Maintenance screen is displayed. Refer to Section 4.3, Sample Trays in


the Operator’s Guide for detailed instructions on placing a tray onto the
sample carousel.

6 Press [F3] System Checks.


The System Checks screen is displayed.

7 Press [F6] Volume.


The Volume Checks screen is displayed.

8 Press [F2] Pipettor 50 mL, [F3] Pipettor 200 mL, or [F8] Low Res. Dispense
350 mL.
The appropriate Pipettor Volume screen is displayed.

NOTE
A message is displayed prompting you to remove and weigh 3 RVs. For
this procedure, you do NOT have to perform this step.

9 Press [F1] Done.

CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.

The wash buffer is dispensed and the reaction vessels are returned to the
shuttle.

10 Open the front panel of the instrument.

11 Using the forceps, remove the reaction vessels from shuttle positions 1, 2,
and 3 (refer to Figure 6-12).

12 Close the front panel of the instrument, then press [Enter].

The shuttle advances 3 positions.

13 Manually pipette 50 mL, 200 mL, or 350 mL of wash buffer (the same amount
selected in step 8) into a reference reaction vessel.

This vessel will be used as a reference for comparison to the 3 reaction


vessels removed from the shuttle.

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Volume Checks

14 Place the reference vessel and the 3 dispensed vessels on a level surface.

15 Visually compare the volumes.

NOTE
Only gross volume discrepancies will be visible.

• If you see a significant volume difference in any of the vessels, call Technical
Support.

16 Inspect the dispensed vessels for air bubbles. Proper main pipettor dispense
will leave no bubbles on the surface, or sometimes a few small, regularly
sized bubbles around the surface edge.

• If you see large, irregularly sized, or an excessive amount of bubbles in any


of the vessels:
- Prime the main pipettor (refer to Section 6.4, System Priming for
instructions).
- Repeat the visual volume check.
- If air bubbles continue, call Technical Support.

17 When you are done with this procedure, press [Esc] twice to return to the
Maintenance screen.

18 Press [F1] Load/Unload Tray.


The Unload Maintenance Tray screen is displayed.

19 When the maintenance tray is presented, unload the tray.

20 Press [F1] Done and then [Enter] to confirm that the maintenance tray is off-
board.

Running This procedure is done on 1 dispense probe at a time. The function key pressed in
Analytical step 4 determines which dispense probe is tested.
Dispense
Probe Volume WARNING
Check 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 Press [F6] Maint. from the Main Menu.


The Maintenance screen is displayed.

2 Press [F3] System Checks.


The System Checks screen is displayed.

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Volume Checks

3 Press [F6] Volume.

The Volume Checks screen is displayed.

4 Press [F4] Dispense Probe 1, [F5] Dispense Probe 2, or [F6] Dispense


Probe 3.

The appropriate Dispense Precision screen is displayed. Refer to Figure 6-17


for identification of the dispense probes.

Tubing Clip
(Revision A fluidics only) Barbed Fittings
7
6

1
5 4 3 2

Dispense Probe 1
(Probe # 1)

Dispense Probe 3 Dispense Probe 2


(Probe # 5) (Probe # 3)

Figure 6-17 Dispense Probes

5 Open the front panel of the instrument.

6 Remove the reaction vessels in positions 1, 2, and 3 in the RV shuttle (refer


to Figure 6-12).

7 Number the vessels.

8 Weigh the vessels using an analytical balance, and record the weights.

NOTES
• After weighing the reaction vessels, handle them with the forceps,
not with your hands.
• The 3 reaction vessels will all be filled by the probe selected in step 4.

9 Place the 3 weighed reaction vessels into the vacated shuttle positions.

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Volume Checks

10 Close the front panel of the instrument, then press [F1] Done.

CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.

The wash buffer is dispensed and the reaction vessels are returned to shuttle
positions 1, 2, and 3.

11 Open the front panel of the instrument.

12 Using the forceps, remove the reaction vessels.

13 Close the front panel of the instrument, then press [Enter].

The shuttle advances 3 positions.

14 Weigh the reaction vessels using the analytical balance, and record the
weights.

15 Repeat steps 5 - 14 for the desired number of replicates.

16 Convert vessel weight to volume using the equation in Table 6-18, then
calculate the mean, standard deviation, and % CV of the replicates.

Volume = weight / density

mL = mg / 1.007 mg/mL (wash buffer density)

Table 6-18 Dispense Probe Weight-to-Volume Conversion

17 Compare the obtained results with the expected results listed in Table 6-19.
If the results are outside the acceptable limits, contact Technical Support for
assistance.

Target Volume - Dispense Probe 1 150 mL

Expected Volume Range 142.5 - 157.5 mL

Expected % CV ˆ 3%
Target Volume - Dispense Probe 2 500 mL

Expected Volume Range 475-525 mL

Expected % CV ˆ 2%
Table 6-19 Dispense Probe Volume Expected Results

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Volume Checks

Target Volume - Dispense Probe 3 500 mL

Expected Volume Range 475-525 mL

Expected % CV £ 2%
Table 6-19 Dispense Probe Volume Expected Results (continued)

18 Repeat steps 4 - 17 for the other dispense probes, as needed.

Running This procedure is done on 1 dispense probe at a time. The function key pressed in
Visual step 4 determines which dispense probe is tested.
Dispense
Probe Volume WARNING
Check 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 Press [F6] Maint. from the Main Menu.


The Maintenance screen is displayed.

2 Press [F3] System Checks.


The System Checks screen is displayed.

3 Press [F6] Volume.


The Volume Checks screen is displayed.

4 Press [F4] Dispense Probe 1, [F5] Dispense Probe 2, or [F6] Dispense


Probe 3.

The appropriate Dispense Precision screen is displayed. Refer to Figure 6-17


for identification of the dispense probes.

NOTE
A message is displayed prompting you to remove and weigh 3 RVs. For
this procedure, you do NOT have to perform this step.

5 Press [F1] Done.

CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.

The wash buffer is dispensed and the reaction vessels are returned to shuttle
positions 1, 2, and 3.

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Volume Checks

6 Open the front panel of the instrument.

7 Using the forceps, remove the reaction vessels.

8 Close the front panel of the instrument, then press [Enter].

The shuttle advances 3 positions.

9 Pipette the appropriate volume of wash buffer into an empty reaction vessel.

This vessel will be used as a reference for comparison to the 3 reaction


vessels removed from the RV shuttle.

• For dispense probe #1, pipette 150 mL of wash buffer.

• For dispense probes #2 and #3, pipette 500 mL of wash buffer.

10 Place the reference vessel and the 3 vessels removed from the shuttle upright
on a level surface.

11 Visually compare the volumes of wash buffer in the reaction vessels.

NOTE
Only gross volume discrepancies will be visible.

• If you see a significant volume difference in any of the vessels, call Technical
Support.

12 Inspect the dispensed vessels for air bubbles. Proper dispense probe
dispense will leave no bubbles on the surface, or sometimes a few small,
regularly sized bubbles around the surface edge.

• If you see large, irregularly sized, or an excessive amount of bubbles in any


of the vessels:
- Prime the dispense probes (refer to Section 6.4, System Priming for
instructions).
- Repeat the visual volume check.
- If air bubbles continue, call Technical Support.

13 Repeat steps 4 - 12 for the other dispense probes as needed.

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

1 Press [F6] Maint. from the Main Menu.


The Maintenance screen is displayed.

2 Press [F3] System Checks.


The System Checks screen is displayed.

3 Press [F6] Volume.


The Volume Checks screen is displayed.

4 Press [F7] Aspirate Probes.


The Aspirate Probes Precision screen is displayed.

5 Open the front panel of the instrument.

6 Remove the reaction vessels in positions 1, 2, and 3 in the RV shuttle (refer


to Figure 6-12).

7 Number the vessels.

8 Weigh the vessels using an analytical balance, and record the weights.

NOTES
• After weighing the reaction vessels, handle them with the forceps,
not with your hands.
• The 3 reaction vessels will each be aspirated by a different probe.

9 Place the 3 weighed reaction vessels into the vacated shuttle positions
according to their numbers.

10 Close the front panel of the instrument, then press [F1] Done.

CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.

Three RVs will be loaded onto the wash/read carousel and 1 wash cycle is
performed on each RV (i.e., 500 mL of wash buffer is dispensed into the RVs,
then the buffer in each reaction vessel is aspirated by a different probe).
After the wash cycle is complete, the RVs are returned to shuttle positions 1,
2, and 3.
11 Open the front panel of the instrument.

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Volume Checks

12 Using the forceps, remove the RVs from positions 1, 2, and 3 (refer to Figure
6-12).

13 Close the front panel of the instrument, then press [Enter].

The shuttle advances 3 positions.

NOTE
When performing an aspirate volume evaluation, ensure that the vessels are
weighed as quickly as possible because the small remaining volume is
especially susceptible to evaporation.

14 Weigh the reaction vessels using the analytical balance, and record the
weights.

15 Repeat steps 5 - 14 for the desired number of replicates.

16 Convert vessel weight to volume using the equation in Table 6-20, then
calculate the mean, standard deviation, and % CV of the replicates.

Volume = weight / density

mL = mg / 1.007 mg/mL (wash buffer density)

Table 6-20 Aspirate Probe Weight-to-Volume Conversion

17 Compare the obtained results with the expected results listed in Table 6-21.

Expected Volume Range 0 - 4 mL

Table 6-21 Aspirate Volume Expected Results

18 If the results are outside the acceptable limits, use Table 6-22 to determine
which aspirate probe should be cleaned/replaced.

Shuttle Position Corresponding Probe

3 Aspirate probe 3 (Probe #6)

2 Aspirate probe 2 (Probe #4)

1 Aspirate probe 1 (Probe #2)

Table 6-22 Aspirate Probe to Shuttle Position Correlation

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Volume Checks

19 Replace and/or clean the corresponding aspirate probe as described in


Section 8.4, Weekly Maintenance, of the Operator’s Guide.

CAUTION
If there is a plugged aspirate probe, do NOT run the Clean Wash Probes
procedure or prime any component of the system until the problem is
resolved.

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

1 Press [F6] Maint. from the Main Menu.


The Maintenance screen is displayed.

2 Press [F3] System Checks.


The System Checks screen is displayed.

3 Press [F6] Volume.


The Volume Checks screen is displayed.

4 Press [F7] Aspirate Probes.


The Aspirate Probes Precision screen is displayed.

NOTE
A message is displayed prompting you to remove and weigh 3 RVs. For
this procedure, you do NOT have to perform this step.

5 Press [F1] Done.

CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.

Three RVs will be loaded onto the wash/read carousel and 1 wash cycle is
performed on each RV (i.e., 500 mL of wash buffer is dispensed into the RVs,
then the buffer in each reaction vessel is aspirated by a different probe).
After the wash cycle is complete, the RVs are returned to shuttle positions 1,
2, and 3.

6 Open the front panel of the instrument.

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Volume Checks

7 Using the forceps, remove the RVs from positions 1, 2, and 3 (refer to Figure
6-12). Note the position from which each RV is removed.

NOTE
You must remember the position from which each RV was removed
because this information is used to determine which aspirate probe is
malfunctioning.

8 Close the front panel of the instrument, then press [Enter].

The shuttle advances 3 positions.

9 Verify complete aspiration by inspecting for fluid remaining in the RV.


There should be no more than a small droplet (ˆ 4 mL) of fluid left in the
bottom of the vessel.

NOTE
To assist you in identifying whether a drop of fluid is within the guideline,
turn the RV upside down. An amount of 4 mL or less will not run out of an
RV when the RV is turned upside down.

10 If the Visual Aspirate Probe Volume Check results fail, (i.e., there is a
significant amount (> 4 mL) of fluid remaining in a vessel), use Table 6-22 to
determine which aspirate probe should be cleaned/replaced.

11 Replace and/or clean the corresponding aspirate probe as described in


Section 8.4, Weekly Maintenance, of the Operator’s Guide.

CAUTION
If there is a plugged aspirate probe, do NOT run the Clean Wash Probes
procedure or prime any component of the system until the problem is
resolved.

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Opening and Closing the Top Cover

6.9
Opening and Closing the Top
Cover

CAUTION
This procedure should be performed only when instructed by a technical
support representative.

This section describes the procedure to open and close the top cover of the
analyzer. You may need to open this cover when troubleshooting or performing a
system support procedure. Do not leave the top cover open when samples are
being processed.

There are 2 types of top cover design:


• Top covers with the “captive screw” design
• Top covers without a captive screw

Procedures for opening and closing both types of top covers are included in this
section.

Determining 1 Open the front panel to locate the captive screw.


the Top Cover
Grasp the lower portion of the left and right sides of the front panel. Pull the
Type
bottom of the panel towards you, then lift the panel upwards (refer to
Figure 6-23).

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Opening and Closing the Top Cover

Front Panel

Figure 6-23 Open Front Panel/Locate Captive Screw

2 Determine if the captive screw is present (refer to Figure 6-23).

The captive screw is located at the top of the pipettor gantry.

3 Close the front panel of the analyzer. (Or, you may leave it open if you have
the captive screw design and you are opening the top cover.)

Refer to the appropriate procedure following this section for detailed instructions
on opening and closing the top cover.

Opening the 1 Open the front panel of the analyzer by grasping the lower portion of the left
Top Cover and right sides of the front panel, pulling the bottom of the panel towards
(Captive you, then lifting the panel upwards (refer to Figure 6-23).
Screw Design)
2 Loosen the “captive” screw located at the top of the pipettor gantry to
release the top cover. The captive screw can be loosened or tightened, but
cannot be removed from its position.

3 Close the front panel of the analyzer.

4 Slide both sides of the top cover back toward the rear of the analyzer
approximately 1/4”, or 6 mm (refer to Figure 6-24).

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Opening and Closing the Top Cover

Top Cover

Figure 6-24 Open Top Cover

CAUTION
Do not attempt to lift the top cover before the cover is retracted.

5 Lift the top cover upwards until it rests in a vertical position.

Closing the 1 Gently pull the top cover down until the cover is horizontal.
Top Cover
2 Press down firmly on both rear corners of the top cover to ensure that the
(Captive
cover is in the correct position.
Screw Design)
3 Pull the top cover forward until the edge of the top cover meets the edge of
the front panel.

4 Open the front panel of the analyzer.

5 Tighten the captive screw located at the top of the pipettor gantry to secure
the top cover. If necessary, gently push the screw into place while turning it.

6 Close the front panel of the analyzer.

© 2000 Copyright Beckman Coulter, Inc. 3/00


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Opening and Closing the Top Cover

Opening and To open the top cover:


Closing the
1 Grasp the left and right sides of the top cover and lift until the brace on the
Top Cover
left side straightens to a diagonal position between the cover and
(No Captive
instrument.
Screw)
2 While holding the cover with your right hand, pull one side of the brace
toward you with your left hand until it locks and the cover rests in a vertical
position.

To close the top cover:

1 Hold the cover open with your right hand and push one side of the brace
away from you until it unlocks.

2 Pull the top cover toward you until the cover is horizontal.

3 Gently press down on the cover to ensure that it is completely closed.

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Peristaltic Waste Pump Tubing Replacement

6.10
Peristaltic Waste Pump Tubing
Replacement

CAUTION
This procedure should be performed only when instructed by a technical
support representative. This section contains instructions for replacing all the
tubing. The technical support representative will help determine which
tubing needs to be replaced.

This section describes the procedure for replacing the tubing on the peristaltic
waste pump (revision B fluidics only) that draws waste fluids from either the
vacuum reservoir or the aspirate probes. This tubing may need to be changed if
you have high % CV values, the reaction vessels are not being fully aspirated, or
waste is not being cleared from the vacuum reservoir bottle.

Items • Replacement peristaltic pump tubing for vacuum reservoir or aspirate probe
Required tubing connection
• 3/32” hex wrench
• Rubber gloves
• Biohazard eye, hand, and facial protection

Procedure
WARNING
Any liquid in the tubing should be considered potentially infectious. Handle
and dispose of the liquid waste in accordance with proper laboratory
procedures.

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 6-53
Peristaltic Waste Pump Tubing Replacement

1 Open the front panel of the analyzer to expose the peristaltic waste pump,
located in the front, left side of the analyzer.

• If the tubing being removed in step 2 goes to an aspirate probe, the aspirate
probe needs to be removed and placed in a cup. This will keep any fluid in
the line or probe from dripping into the wash/read carousel. Refer to
Section 8.4, Weekly Maintenance, of the Operator’s Guide.

2 Using both hands, pull the opaque waste pump tubing from the connector
that attaches either to the right side of the pump (opaque vacuum tubing) or
to the clear tubing connected to the aspirate probe (opaque aspirate tubing).
Refer to Figure 6-25.

NOTES
• The tubing which must be disconnected in step 2 depends on which tubing
must be replaced. Contact Technical Support for assistance in determining
what tubing should be replaced.
• If a metal connector on the base of the pump pulls out of its plastic fitting
while removing the tubing, pull the metal connector free from the tubing.
Loosen the plastic fitting on the pump base, and insert the metal connector
into the fitting. Tighten the fitting to the base before proceeding.

Opaque Vacuum Tubing

Clear tubing to
aspirate probe

Opaque Aspirate
Tubing

Lever Guard
Plastic Fittings with
Metal Connectors

Figure 6-25 Peristaltic Waste Pump

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6-54 Rev 101740L Access Reference Manual
Peristaltic Waste Pump Tubing Replacement

3 Pull the other end of the tubing off of the waste pump base to the left of the
pump.

4 Using a 3/32” hex wrench, loosen the screws that secure the lever guard and
remove the guard.

5 Push the lever on the cassette you are removing the tubing from as far to the
right as possible. This will release the cassette from the pump.

6 Pull the cassette toward you and slide it free of the waste pump (refer to
Figure 6-26).

Cassette

Tubing Retainer Clips

Figure 6-26 Peristaltic Waste Pump with Removed Cassette

7 Pull the tubing from the center of the cassette.

8 Using the tubing that you removed as a measurement guide, cut the new
tubing to the correct length.

9 Push the new tubing into the cassette, keeping the retainer clips positioned
as shown in Figure 6-26.

10 Slide the cassette back into its position in the waste pump and push its lever
about 90• to the left.

11 Push the left end of the new tubing onto the correct metal tubing on the left
side of the pump.

12 Push the other end of the tubing onto the connector attaching it to either the
right side of the pump (for vacuum tubing) or to the clear aspirate probe
tubing (for opaque aspirate tubing).

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Access Reference Manual Rev 101740L 6-55
Peristaltic Waste Pump Tubing Replacement

• If an aspirate probe was removed, reinstall the probe into its proper location
on the wash arm. Refer to Section 8.4, Weekly Maintenance, of the Operator’s
Guide.

13 Repeat steps 2-12 for each piece of tubing that needs to be replaced.

14 Close the front panel of the analyzer.

15 Prime the system using the Dispense Probes option from the Fluidics
Priming screen.

Use the default number of cycles for each component. Refer to Section 6.4,
System Priming, in this manual.

Verification 16 Run the Visual Dispense Probe Volume Check procedure.

Refer to Section 6.8, Volume Checks, of this chapter. If the results of this
procedure fail, call Technical Support.

17 Run the Visual Aspirate Probe Volume Check procedure.

Refer to Section 6.8, Volume Checks, of this chapter. If the results of this
procedure fail, call Technical Support.

18 Run the System Check procedure.

Refer to Section 8.4, Weekly Maintenance, in the Operator’s Guide. If the


results of this procedure fail, call Technical Support.

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System Shut Down and Restart

6.11
System Shut Down and Restart

This section describes the procedures for shutting down and restarting the Access
System. You should shut down the analyzer to move the system or whenever it
will be turned off for an extended period of time (approximately 5 to 7 days). The
Access System does not require periodic shut down. Before shutting down the
system, confirm your decision with Technical Support.

The shut down procedure is the same for revision A and B fluidics, but the restart
procedures are different. In addition, the restart procedure for revision A fluidics
varies depending on the type of wash and waste valves installed in the system.
Refer to Section 1.2, Instrument Description in this manual to determine which
restart procedure to follow.

Shutting Down 1 Run the Special Clean procedure.


the Analyzer
Refer to Section 6.13, Special Clean Procedure.

2 Empty the liquid waste bottle.

Refer to Section 2.10, Liquid Waste, of the Operator’s Guide.

3 Turn the power switch on the right side of the analyzer to the Off (O)
position.

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System Shut Down and Restart

Restarting
Analyzers CAUTION
with Revision
Use this procedure only on systems with revision A fluidics. Do not use this
A Fluidics
procedure for revision B fluidics. Refer to Section 1.2, Instrument Description
to determine if your system has revision A or B fluidics.

NOTE
The substrate used in this procedure must be equilibrated to room temperature
for the time specified in the product insert before you load it on the analyzer.
Refer to the product insert for detailed information.

1 Ensure that the wash buffer supply is adequate.

• If necessary, replenish the wash buffer supply. Refer to Section 2.9, Wash
Buffer, of the Operator’s Guide.

2 Turn the power switch on the right side of the analyzer to the On (|)
position.

NOTE
Steps 3 through 13 only need to be performed if the analyzer has the ceramic
valves. Refer to Fluidic Module in Section 1.2, Instrument Description, in this
manual to locate the waste and wash valves. The original valves are blue. The
ceramic valves have a clear body and black screw-on cap. If you cannot
determine which valves are installed on your system, please call Technical
Support.

For systems with the original (blue) wash and waste valves, skip to step 14.

3 From the Main Menu, press [F7] Diagnostics.

The Diagnostics screen is displayed.

4 Press [F2] Mechanics.

The Mechanics screen is displayed.

5 Press [F1] Select Primary Device.

A list of devices is displayed.

6 Press [Down Arrow] to highlight Wash Valve, then press [Enter].

7 Press [F2] Home Device.

The wash valve will move to its home position.

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8 Press [F2] Home Device 9 more times.

Each time, the wash valve will move slightly away from, and then back to,
its home position.

9 Press [F1] Select Primary Device.

A list of devices is displayed.

10 Press [Down Arrow] to highlight Waste Valve, then press [Enter].

11 Press [F2] Home Device.

The waste valve will move to its home position.

12 Press [F2] Home Device 9 more times.

Each time, the waste valve will move slightly away from, and then back to,
its home position.

13 Press [F9] Main Menu.

The Main Menu is displayed.

14 Prime the main pipettor and then the dispense probes.

Use the default number of cycles for each component. Refer to Section 6.4,
System Priming in this manual.

15 Run the Visual Dispense Probe Volume Check procedure.

Refer to Section 6.8, Volume Checks, of this chapter. If the results of this
procedure fail, call Technical Support.

16 Run the Visual Aspirate Probe Volume Check procedure.

Refer to Section 6.8, Volume Checks, of this chapter. If the Visual Aspirate
Probe Volume Check results fail, the procedure may refer you to clean and/
or replace appropriate aspirate probes, according to procedures in Section
8.4, Weekly Maintenance, of the Operator’s Guide, and then run the Visual
Aspirate Probe Volume Check procedure again.

CAUTION
If the Visual Aspirate Probe Volume Check results fail again, do not proceed
with the Special Clean procedure. Contact Technical Support.

17 Run the Special Clean procedure.

Refer to Section 6.13, Special Clean Procedure.

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System Shut Down and Restart

18 Replace the current bottle of substrate with a fresh bottle.

Refer to Section 2.6, Substrate of the Operator’s Guide.

19 Run the System Check procedure.

Refer to Chapter 8, Routine Maintenance, in the Operator’s Guide.

• If the System Check results fail, repeat the procedure. If the results fail again,
refer to Chapter 5, Troubleshooting for further instructions.

Restarting
Analyzers CAUTION
with Revision Use this procedure only on systems with revision B fluidics. Do not use this
B Fluidics procedure for revision A fluidics. Refer to Section 1.2, Instrument Description
to determine if your system has revision A or B fluidics.

NOTE
The substrate used in this procedure must be equilibrated to room temperature
for the time specified in the product insert before you load it on the analyzer.
Refer to the product insert for detailed information.

1 Ensure that the wash buffer supply is adequate.

• If necessary, replenish the wash buffer supply. Refer to Section 2.9, Wash
Buffer, of the Operator’s Guide.

2 Turn the power switch on the right side of the analyzer to the On (|)
position.

3 From the Main Menu, press [F7] Diagnostics.

The Diagnostics screen is displayed.

4 Press [F2] Mechanics.

The Mechanics screen is displayed.

5 Press [F1] Select Primary Device.

A list of devices is displayed.

6 Press [Down Arrow] to highlight Wash Valve, then press [Enter].

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7 Press [F2] Home Device.

The wash valve will move to its home position.

8 Press [F2] Home Device 9 more times.

Each time, the wash valve will move slightly away from, and then back to,
its home position.

9 Press [F1] Select Primary Device.

A list of devices is displayed.

10 Press [Down Arrow] to highlight Precision Valve, then press [Enter].

11 Press [F2] Home Device.

The precision valve will move to its home position.

12 Press [F2] Home Device 9 more times.

Each time, the precision valve will move slightly away from, and then back
to, its home position.

13 Press [F9] Main Menu.

The Main Menu is displayed.

14 Prime the system.

Use the default number of cycles for each component. Refer to Section 6.4,
System Priming, in this manual.

15 Run the Visual Dispense Probe Volume Check procedure.

Refer to Section 6.8, Volume Checks, in this manual. If the results of this
procedure fail, call Technical Support.

16 Run the Visual Aspirate Probe Volume Check procedure.

Refer to Section 6.8, Volume Checks. If the volume check results fail, the
procedure may refer you to Replacing and Cleaning Aspirate Probes in
Section 8.4 of the Operator’s Guide.

• If you replace and clean the aspirate probes, run the Visual Aspirate Probe
Volume Check procedure again. If the results fail again, call Technical
Support. Only when directed by Technical Support, refer to Section 6.10,
Peristaltic Waste Pump Tubing Replacement for continued troubleshooting.

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System Shut Down and Restart

CAUTION
If the Visual Aspirate Probe Volume Check results fail after replacing the
waste pump tubing, do not proceed with this procedure. Contact Technical
Support.

17 Run the Special Clean procedure.

Refer to Section 6.13, Special Clean Procedure.

18 Replace the current bottle of substrate with a fresh bottle.

Refer to Section 2.6, Substrate of the Operator’s Guide.

19 Run the System Check procedure.

Refer to Chapter 8, Routine Maintenance, of the Operator’s Guide.

• If the System Check results fail, repeat the procedure. If the results fail again,
refer to Chapter 5, Troubleshooting for further instructions.

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Establishing Control Ranges

6.12
Establishing Control Ranges
This section provides a recommendation to establish control ranges for the Access
Immunoassay System. This information is a recommendation ONLY and is not
intended to replace your existing laboratory procedure(s); use this procedure in
conjunction with your standard laboratory practices and/or the manufacturer’s
recommendations for the quality control materials you use.

NOTES
• Use fresh control materials to ensure accurate results (refer to Section 4.4,
Sample Processing, of the Operator’s Guide for the time limitation for on-
board samples).
• Do not reuse controls by pooling into sample cups or storage containers.
• Refer to Chapter 4, System Processing, of your Operator’s Guide for more
information regarding sample processing.

Items • Access System assay calibrators (2 lots, if available)


Required • Access System reagent packs (2 lots, if available)
• Tri-level controls (prepare the controls according to the manufacturer's
directions)

Collecting 1 Run 1 or 2 replicates of each control once per day. From day to day, vary the
Data Points sequence in which the control samples are processed.

2 Each day, record the values as follows:

• If 1 replicate is run, record only 1 value per control level.

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Establishing Control Ranges

• If 2 replicates are run, record both individual values.


• Do not exceed 2 recorded values per day.

3 For each calibrator lot/reagent pack lot combination, obtain a minimum of


15 values per control level on at least 3 different calibration curves (45 values
minimum). Use a combination of fresh and stored curves.

4 Calculate the mean, % CV, 1SD, 2SD, and 3SD values, and the 3SD range for
each control level/analyte combination.

5 Perform outlier evaluation:

• Remove any values outside of the 3SD range (outliers), then recalculate
the mean, % CV, 1SD, 2SD and 3SD values. Proceed to step 6.
• If no outliers are detected, use the data calculated in step 4 and proceed
to step 7.

6 Perform a second outlier evaluation. Remove any values outside of the


3SD range, then recalculate the mean, % CV, 1SD, 2SD and 3SD values.

7 Calculate the acceptable 1SD, 2SD, and 3SD control ranges.

• If the % CV < 6, you may consider widening the ranges by multiplying the
stated SD by 1.5, then recalculating the 1SD, 2SD, and 3SD ranges.

8 The values and ranges should be periodically recalculated during the life of
the control lot.

Assigning To assign temporary, or provisional, control ranges:


Temporary
1 Run 1 or 2 replicates of each control daily.
Control
Ranges 2 Each day, record the values as follows:

• If 1 replicate is run, record only 1 value per control level.


• If 2 replicates are run, record both individual values.
• Do not exceed 2 recorded values per day.

3 Obtain at least 20 values per control level.

4 Calculate the mean for each control level/analyte combination.

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Establishing Control Ranges

5 Verify that the calculated mean is within the manufacturer assigned range
provided in the control sera product insert (if more than 1 range is listed, use
the 2SD range).

• If the mean is within the assigned range, calculate a temporary range for
each control level.
• If the mean is not within the assigned range, contact Technical Support.
• If no manufacturer assigned ranges are listed in the product insert,
contact Technical Support.

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Access Reference Manual Rev 101740L 6-65
Special Clean Procedure

6.13
Special Clean Procedure
The special clean procedure prevents buildup of debris on the primary, dispense,
and aspirate probes of the Access System. Perform the Special Clean procedure
when:
• Shutting down or restarting the Access System (refer to Section 6.11, System
Shut Down and Restart for more information).
• Troubleshooting procedures in an Access manual advise you to perform it.
• Technical Support instructs you to perform it.

NOTE
Beckman Coulter recommends that if you use the Access System to process the
B12 assay, you perform the Special Clean procedure at the end of each day, or
whenever the instrument will be idle for 8 hours or more.

CAUTIONS
• Unless you have an emergency problem with the instrument, do not
press [F8] Cancel to stop a maintenance procedure. Cancelling the
procedure may cause damage to the instrument and may compromise the
integrity of results for subsequent tests.
• If you have an emergency problem with the instrument while a
maintenance procedure is running, press [F8] Cancel, but do not initialize
the system. Call Technical Support for assistance.

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Special Clean Procedure

Materials • 13 mm sample tray for 2 mL Sample Cups—a sample tray used for a
Required maintenance procedure is also called a maintenance tray
• Six Access 2.0 mL Sample Cups

NOTE
Use only the 2.0 mL Sample Cup when performing routine maintenance
procedures. Using any other sample container may result in level sensing
errors and cancellation of the maintenance routine.

• Contrad 70 cleaning solution


• Citranox cleaning solution
• Deionized water or wash buffer
• 70% methanol

WARNINGS
• Contrad 70 cleaning solution is alkaline and may cause severe eye
irritation or mild skin irritation. Refer to the manufacturer’s label for
details.
• Citranox cleaning solution is acidic and may cause eye or skin irritation.
Refer to the manufacturer’s label for details.

Performing 1 Place empty 2.0 mL Sample Cups in sample positions 1, 2, 3, 6, 7, and 8 of an


the Special empty maintenance tray. (Leave sample positions 4 and 5 empty.)
Clean
2 Pipette 2.0 mL of Contrad 70 cleaning solution into the 2.0 mL Sample Cup
Procedure
in sample position 1.

3 Pipette 2.0 mL of a 1/5 dilution of Citranox cleaning solution (mix 1 part


Citranox solution and 4 parts deionized water) into the 2.0 mL Sample Cup
in sample position 2.

4 Pipette 2.0 mL of deionized water or wash buffer into the 2.0 mL Sample
Cup in sample position 3.

5 Pipette 2.0 mL of 70% methanol into each of the cups in sample positions 6,
7, and 8.

6 Press [F6] Maint. from the Main Menu.

The Maintenance screen is displayed.

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Special Clean Procedure

7 Press [F1] Load/Unload Tray.

The Load Maintenance Tray screen is displayed with the cursor in the Tray
ID field.

8 Enter the Tray ID for the maintenance tray.

9 When the tray loading position is presented, load the maintenance tray (for
instructions on placing a tray onto the sample carousel, refer to Section 4.3,
Sample Trays in the Operator’s Guide).

10 Press [F1] Done and then [Enter] to confirm that the maintenance tray is
loaded.

11 Ensure the system is in the READY mode, then press [F6] Special Clean.

CAUTION
Do not press [F8] Cancel unless you have an emergency problem with
the instrument.

Messages in the prompt line inform you of the cleaning status. The
procedure takes about 35 minutes to complete with revision B fluidics, and
about 45 minutes with revision A fluidics.

12 When the procedure is completed, press [F1] Load/Unload Tray.

The Unload Maintenance Tray screen is displayed.

13 When the maintenance tray is presented, unload the tray (for instructions on
removing a tray from the sample carousel, refer to Section 4.3, Sample Trays
in the Operator’s Guide).

14 Press [F1] Done and then [Enter] to confirm that the maintenance tray is off-
board.

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Incubator Belt Procedures

6.14
Incubator Belt Procedures
This section describes these incubator belt procedures:
• Replacing vessel holders (also called incubator belt clips)
• Calibrating the incubator belt
• Running the system exerciser test

Calibrating the incubator belt corrects for slight variations in the distance from the
center of one dovetail to the center of the next dovetail on the incubator belt (refer
to Figure 6-30). Incubator belt calibration is required when:
• Any vessel holder is replaced
• The home vessel holder (a vessel holder with a magnet attached to its top) is
moved to a position other than its original position

After you perform incubator belt maintenance, Beckman Coulter recommends


that you run the system exerciser test to verify that the system is functioning
properly before you process samples.

Materials • Original (no hole through the top) or chamfered (hole through the top)
Required vessel holders; original vessel holders are shown in Figure 6-30
• Original “home” vessel holder with magnet or chamfered “home” vessel
holder with magnet
• Small screwdriver
• Hemostat
• Hex wrench, 9/64”
• Black felt-tip marker

NOTES
• Remember to reorder any CARE kit parts that you use. Please contact
Technical Support for ordering information.

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Incubator Belt Procedures

• If the instrument has original vessel holders, you must replace them with
original vessel holders. If the instrument has chamfered vessel holders, you
must replace them with chamfered vessel holders.

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.

Removing NOTE
Covers
Before beginning this procedure, ensure that no samples are being processed and
that the analyzer is in the READY or NOT READY mode.
• If the Event Log icon at the bottom of the screen is red before you begin
these procedures, press [Scroll Lock] to check the Event Log for error
messages. Checking the Event Log clears the icon and aids you in detecting
any future errors.

• If the Event Log icon turns red at any time during the following procedures,
check the Event Log messages before proceeding.

1 Open the front panel of the instrument by grasping the lower portion of the
left and right sides of the front panel, pulling the bottom of the panel
towards you, then lifting the panel upwards (refer to Figure 6-27).

Front Panel

Supply Cover

Hex Screws
(under Front Panel)

Figure 6-27 Front Panel, Supply Cover, and Hex Screws

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Incubator Belt Procedures

2 Remove the 9/64” hex screw from each end of the supply cover. The screws
are located where the supply cover meets the instrument frame (refer to Figure
6-27).

3 Remove the reaction vessel waste bag and the 9/64” hex screw in the bottom
of the waste bag well.

4 Lift off the supply cover (refer to Figure 6-27) and set it aside.

• If the substrate bottle is onboard the analyzer (not in the fluids tray), remove
the substrate bottle and set it aside without disconnecting the supply line
from the substrate bottle.

5 Release the RV load door latch using a small screwdriver, and raise the RV load
door slightly (refer to Figure 6-28).

6 At the front corners of the incubator cover, pull lightly outward on the cover
release tabs and lift the cover up and forward until it is off (refer to Figure 6-
28). Set the cover aside.

Incubator Cover Retaining Slots

Incubator Cover
Release Tabs RV Load Door Frame
Retainers
RV Load Door RV Load Door Latch

Figure 6-28 RV Load Door and Incubator Cover

Removing 7 Use the hemostat to remove all reaction vessels (RVs) and any broken vessel
Failed Vessel holder legs (refer to Figure 6-30) from the visible area of the incubator track.
Holders and Save all removed broken vessel holder legs.
Fallen RVs

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Incubator Belt Procedures

8 Remove any vessel holders that have broken or bent legs by pulling up on
the tab at the top of the vessel holder (refer to Figure 6-30). Save all vessel
holders with broken legs.

9 Press [F7] Diag. from the Main Menu.

The Diagnostics screen is displayed.

10 Press [F2] Mechanics.

The Mechanics screen is displayed.

11 Press [F8] Disable Motors.

All motors are disabled.

CAUTION
If the incubator belt resists movement during step 12, stop rotating it and
remove any visible vessel holders that might have been damaged. Call
Technical Support for assistance.

12 Attempt to rotate the incubator belt clockwise by hand and remove all
visible RVs and any broken vessel holder legs.

Move the belt by turning the incubator belt pulleys (refer to Figure 6-29)
or by pulling horizontally on the dovetails or vessel holders (refer to
Figure 6-30).

Incubator Belt Pulleys

Incubator

Figure 6-29 Incubator Belt Pulleys

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Incubator Belt Procedures

13 Match the number of broken vessel holders removed in steps 8 and 12 to the
number of broken legs retrieved from the instrument to ensure there are no
vessel holder pieces left in the instrument.

CAUTION
If there are still vessel holder legs or pieces missing, call Technical Support for
assistance. Leaving them in the instrument may damage the analyzer.

Replacing 14 Replace any broken or damaged vessel holders with new ones.
Vessel
Holders The vessel holders should gently “snap” into place when they are fully
seated in the downward direction.

NOTES
• If the home vessel holder (with magnet) is broken, be sure to replace it with
another home vessel holder.
• If the instrument has original vessel holders, replace them with original
vessel holders. If the instrument has chamfered vessel holders (hole in top),
replace them with chamfered vessel holders.

Home Vessel Holder

Incubator Belt

Tab

Dovetail

Leg

Vessel Holder

Figure 6-30 Original Incubator Belt, Vessel Holders, and Dovetail

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Incubator Belt Procedures

Validating 15 Press [F1] Select Primary Device.


Vessel Holder
Replacement A menu of options is displayed.

16 Use the [Up Arrow] or [Down Arrow] key to highlight RV Shuttle, then
press [Enter].

• If the round LED indicator labeled Index is light green, proceed to step 17.

CAUTION
If the Index indicator is dark green, call Technical Support for assistance. The
RV shuttle is not fully retracted from the incubator belt area. Any movement
of the incubator belt might damage the instrument.

17 Press [F1] Select Primary Device.

A menu of options is displayed.

18 Use the [Up Arrow] or [Down Arrow] key to highlight Wash Carousel, then
press [Enter].

• If the round LED indicator labeled Index is light green, proceed to step 19.

CAUTION
If the Index indicator is dark green, call Technical Support for assistance. The
wash carousel could be encroaching on the incubator belt area. Any movement
of the incubator belt might damage the instrument.

19 Place an RV in an empty vessel holder at the waste chute entrance (lift up on


the vessel holder tab, place the RV under the vessel holder, and slide the
vessel holder back onto the incubator belt). Mark the RV with a black felt-tip
marker.

20 Rotate the incubator belt clockwise by hand until the RV placed in step 19
has moved 1 revolution.

CAUTION
If the belt resists movement, stop rotating it. Call Technical Support for
assistance.

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Incubator Belt Procedures

21 Rotate the incubator belt counterclockwise by hand 1 revolution.

CAUTION
If the belt resists movement, stop rotating it. Call Technical Support for
assistance.

22 Remove the RV placed in a vessel holder in step 19.

23 Press [F8] Enable Motors from the Mechanics screen.

24 Press [F1] Select Primary Device.

A menu of options is displayed.

25 Use the [Up Arrow] or [Down Arrow] key to highlight Incubator Belt, then
press [Enter].

26 Press [F2] Home Device.

,I 7KHQ

The Event Log icon did not turn red and The incubator belt was homed
there are no error messages successfully.

The Event Log icon turned red Check the Event Log messages
and call Technical Support
before proceeding.

27 Press [Esc].

The Diagnostics screen is displayed.

28 Press [F1] System Init.

A confirmation message is displayed.

29 Ensure Yes is highlighted, then press [Enter].

Initialization of all primary system devices begins. When initialization is


complete, the Diagnostics screen is displayed.

30 Press [F2] Mechanics.

The Mechanics screen is displayed with Incubator Belt shown in the Primary
Device field.

31 Press [F2] Home Device.

32 Press [Tab] until the cursor is in the Wash Out field.

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33 Press [F3] Move to Position.

The incubator belt rotates counterclockwise until a specific vessel holder


aligns with the wash out transfer location on the wash/read carousel.

34 Press [F6] Start Cycling.

The incubator belt moves rapidly back and forth between the wash out
transfer location and the home positions. Allow it to continue moving for 1
minute.

35 Press [F8] Stop Cycling.

The [F8] Stop Cycling key is displayed after [F6] Start Cycling is pressed.

The incubator belt stops moving.

36 Check the Event Log icon at the bottom of the screen.

• If the Event Log icon background is gray, proceed to the next section.

• If the Event Log icon background is yellow or red, review the Event Log and
call Technical Support for assistance.

Calibrating
Incubator Belt CAUTION
Before proceeding, verify that the incubator belt is not obstructed and that all
vessel holders are fully seated, or the system may be damaged. Ensure there is
only 1 home vessel holder on the belt. (Refer to Figure 6-30 for an illustration
of the home vessel holder with the magnet.)

1 Ensure that the analyzer is in the READY mode.

2 Press [F7] Diag. from the Main Menu.

The Diagnostics screen is displayed.

3 Press [F8] More Options.

A menu of options is displayed.

4 Use the [Up Arrow] or [Down Arrow] key to highlight Calib. Incubator
Belt, then press [Enter].

The system immediately begins a 45-second calibration routine. The belt will
move clockwise, then counterclockwise. When the belt has stopped moving,
the calibration routine is complete.

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5 Check the Event Log icon at the bottom of the screen.

• If the icon is gray, the calibration routine was successful.

• If the icon is yellow, please call Technical Support to arrange scheduled


service. The instrument is operable and the system will function. However,
the message posted in the Event Log (accessed by pressing [Scroll Lock])
indicates that the calibration routine was borderline.

• If the icon is red, please call Technical Support immediately. The message
posted in the Event Log (accessed by pressing [Scroll Lock]) indicates that
the calibration routine has failed.

Running 1 Press [F7] Diag. from the Main Menu.


System
The Diagnostics screen is displayed.
Exerciser Test
2 Press [F8] More Options.

A menu of options is displayed.

3 Use the [Up Arrow] or [Down Arrow] key to highlight Exerciser, then press
[Enter].

The System Exerciser screen is displayed.

4 Press [F1] Select Exerciser Test.

A menu of options is displayed.

5 Use the [Up Arrow] or [Down Arrow] key to highlight Vessel Holder, then
press [Enter].

6 Press [F2] Start Cycling.

The system immediately begins an exercise routine to ensure that the system
is functioning properly.

7 Press [F8] Stop Cycling after 2 is displayed in the Cycles Completed field.

The [F8] Stop Cycling key is displayed after [F2] Start Cycling is pressed.
The test will stop after the 3rd cycle is completed.

• If you are running this system exerciser test at the request of Technical
Support, this procedure is complete.

• If you are performing this procedure after replacing vessel holders, continue
to the next steps to prepare the instrument for processing.

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Incubator Belt Procedures

8 Press [F9] Main Menu.

The Main Menu is displayed.

9 Reinstall the incubator cover by raising the RV load door slightly using a
small screwdriver, moving the load door through the large opening in the
cover, and sliding the cover retaining slots under the load door frame
retainers (refer to Figure 6-28).

10 Hook both cover release tabs over the front corners of the incubator housing
(refer to Figure 6-28).

• If the substrate bottle is kept onboard the analyzer (not in the fluids tray),
reinstall the substrate bottle.

11 Reinstall the supply cover and the 9/64” hex screws in the bottom of the
waste bag well and at each end of the supply cover.

12 Reinstall the reaction vessel waste bag by sliding the plastic tab on the bag
fully into the slot on the waste chute.

13 Close the front panel of the instrument.

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6-78 Rev 101740L Access Reference Manual
Main Pipettor Procedures

6.15
Main Pipettor Procedures
This section describes the procedures for:
• Replacing the primary probe and properly using the pipettor torque tool.
• Inspecting and cleaning the pipettor gantry.

Replacing the The primary probe must be replaced if it is plugged, bent, or otherwise damaged.
Primary Probe
Materials Required
• Pipettor torque tool
• 5/16” open end wrench
• 1/4” open end wrench
• Primary probe

NOTE
Remember to reorder any parts of your CARE kit that you use.

Special Handling Instructions

WARNING
The primary probe is considered to be contaminated and should be handled
according to proper laboratory procedure. Proper hand, eye, and facial
protection is required.

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 6-79
Main Pipettor Procedures

Removing Primary Probe

NOTE
Do not use the pipettor torque tool to remove the primary probe. The tool may
be damaged if used in a manner other than that described in the Installing
Primary Probe section of this chapter.

1 Ensure that the system is in either the READY or NOT READY mode.

2 Open the front panel to disable the system motors and access the main
pipettor.

3 Move the main pipettor just to the left of the probe wash tower (refer to
Figure 6-31).

Probe Wash Tower

Main Pipettor

Lower end
Fit the 5/16" of Ultrasonic
wrench here Transducer

Probe Nut

Primary Probe

Figure 6-31 Primary Probe Assembly

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6-80 Rev 101740L Access Reference Manual
Main Pipettor Procedures

4 Place the 5/16” wrench on the flat sides of the lower end of the ultrasonic
transducer above the probe nut, as shown in Figure 6-31.

This wrench is used to keep the main pipettor from rotating when the probe
nut is loosened.

CAUTION
Do not exert pressure with the 5/16” wrench or the pipettor may be damaged.

5 Place the 1/4” wrench on the probe nut so that the handle is on the right
hand side of the probe nut (refer to Figure 6-31).

6 Loosen the probe nut by holding the 5/16” wrench in place and moving the
1/4” wrench to the left.

7 Remove both wrenches.

8 Continue to turn the nut by hand until you have removed the nut (with the
probe inside) from the lower end of the ultrasonic transducer.

9 Separate the primary probe from the probe nut. Dispose of the probe
according to proper laboratory procedures.

Retain the probe nut for use when installing the new primary probe.

Installing Primary Probe


1 Inspect the new primary probe to ensure that it is straight.

2 Insert the new primary probe into the probe nut (refer to Figure 6-32) and
install the probe and nut onto the lower end of the ultrasonic transducer
(refer to Figure 6-31).

Probe Nut

Primary Probe

Figure 6-32 Inserting Primary Probe into Probe Nut

3 Finger tighten the probe nut.

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Access Reference Manual Rev 101740L 6-81
Main Pipettor Procedures

4 Place the 5/16” wrench on the flat sides of the lower end of the ultrasonic
transducer above the probe nut, as shown in Figure 6-31.

This wrench is used to keep the main pipettor from rotating when the probe
nut is tightened.

CAUTION
Do not exert pressure with the 5/16” wrench or the pipettor may be damaged.

5 With the stationary bar toward the left side of the instrument, fit the 1/4”
hex opening of the pipettor torque tool (refer to Figure 6-33) on the probe
nut.

Press here to rotate Stationary Bar

Tension Bar (do not touch) 1/4" Hex Opening

Figure 6-33 Pipettor Torque Tool

NOTE
Do not touch the tension bar (refer to Figure 6-33) while rotating the pipettor
torque tool in step 6.

CAUTION
Do not overtighten the probe nut. Overtightening the probe nut could severely
damage the ultrasonic transducer.

6 While holding the 5/16” wrench in place, place a finger or thumb in the
notch on the pipettor torque tool (refer to Figure 6-33) and press the
stationary bar to the right (toward the reagent/sample carousel) until the
stationary bar touches the tension bar.

The primary probe is now properly installed.

7 Remove the 5/16” wrench and torque tool and close the front panel.

Verification
1 Press [F7] Diag. from the Main Menu.

The Diagnostics screen is displayed.

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6-82 Rev 101740L Access Reference Manual
Main Pipettor Procedures

2 Press [F1] System Init to initialize the system.

3 Press [F6] Maint. from the Main Menu.

The Maintenance screen is displayed.

4 Press [F4] Fluidics Priming.

The Fluidics Priming screen is displayed.

5 Press [F1] Pipettor to run the default number of cycles.

6 Perform the System Check procedure.

7 Calibrate your assays and verify the calibrations by running controls.

Expected Outcome
1 The System Check results must meet all specifications.

2 All control results should be within the acceptable ranges.

If the controls are not within the acceptable ranges, recalibrate the assay(s)
and rerun the controls.

Inspecting Inspect and clean the pipettor gantry when:


and Cleaning • You receive pipettor X motion errors on the event log.
the Pipettor • Technical Support instructs you to inspect and clean the pipettor gantry.
Gantry

CAUTIONS
• Wipe ONLY the lower pipettor gantry shaft to remove debris. The lower
shaft is not lubricated.
• A special lubricant is applied to the upper pipettor gantry shaft to protect
it from corrosion. DO NOT wipe the upper shaft, nor touch, nor remove
the lubricant. A thin film of lubricant on the upper shaft is normal. A
small amount of surface dust may accumulate on the upper shaft, but it is
not harmful.

Material Required
• Lint-free cloth

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Access Reference Manual Rev 101740L 6-83
Main Pipettor Procedures

Inspecting and Cleaning


1 Open the front panel of the analyzer and access the pipettor gantry. To open
the front panel, grasp the lower portion of the left and right sides, pull the
bottom towards you, then lift upward.

2 Inspect the upper pipettor gantry shaft for corrosion (refer to Figure 6-34). If
you notice significant corrosion, or suspect that fluid or some other material
came in contact with the pipettor gantry, call Technical Support.

3 Wipe the lower pipettor gantry shaft to either side of the main pipettor
carriage with a clean, lint-free cloth to remove debris (refer to Figure 6-34).

The lower pipettor gantry shaft is not lubricated so there is no concern of


inadvertently removing the lubricant.

Main Pipettor Upper Pipettor


Carriage Gantry Shaft

Lower Pipettor
Gantry Shaft

Figure 6-34 Pipettor Gantry

4 Move the main pipettor carriage a few inches to the right or left to expose the
section of the lower pipettor gantry shaft that was covered by the carriage.

5 Wipe the remaining section of the lower pipettor gantry shaft with the cloth.

6 Close the front panel.

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6-84 Rev 101740L Access Reference Manual
Replacing the Waste Filter Bottle

6.16
Replacing the Waste Filter
Bottle
Replace the waste filter bottle when:
• You find fluid in the bottle during the weekly maintenance inspection.
• Troubleshooting procedures in an Access manual advise you to replace it.
• Technical Support instructs you to replace it.

Top of the
Waste Filter/Bottle Assembly

Waste Filter Bottle

Figure 6-35 Waste Filter/Bottle Assembly in Unibase Fluids Tray

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 6-85
Replacing the Waste Filter Bottle

Materials • Clean waste filter bottle


Required
For convenience, two waste filter bottles are included with the system so
that the bottles can be cycled with one being installed on the system while
the other is removed, decontaminated, and emptied.

Replace the 1 Unscrew the waste filter bottle from the top of the waste filter/bottle
Waste Filter assembly (refer to Figure 6-35).
Bottle
2 Place the top of the waste filter/bottle assembly in a clean waste filter bottle
and screw-tighten the bottle.

WARNINGS
• The filter is a biohazard. Therefore, do not lay the filter down on
any surface. Immediately place the filter in a clean waste bottle.
• 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.
3 Decontaminate the contents of the removed waste filter bottle in accordance
with proper laboratory procedures before disposing of the liquid.

4 Empty the contents of the bottle.

5 Rinse the bottle thoroughly by filling it with tap water and discarding the
contents.

6 Rinse the bottle a second time with tap water and allow the bottle to air dry.

NOTE
If desired, the waste filter bottle can be autoclaved.

7 Retain the clean bottle for the next time you need to replace the waste filter
bottle.

5/03 © 2003 Beckman Coulter, Inc.


6-86 Rev 101740S Access Reference Manual
System Configuration

7
System Configuration
• Introduction (Section 7.1)............................................................................. 7-2

• Configure System (Section 7.2) ................................................................... 7-4

• Configure Internal Bar Code Reader (Section 7.3) ................................. 7-11

• Configure Laboratory Information (Section 7.4) .................................... 7-18

• Configure Tests (Section 7.5) ..................................................................... 7-22

• Configure Calibrators and Calibration Controls (Section 7.6).............. 7-31

• Configure Controls (Section 7.7) ............................................................... 7-38

• System Configuration Worksheets (Section 7.8)..................................... 7-46

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 7-1
Introduction

7.1
Introduction
Access System configuration consists of setting the system default values and
formats, and selecting the tests, calibrators, and controls to be used. System
configuration consists of the following:
• System parameters
• Laboratory information
• Tests
• Calibrators (and calibration controls)
• Controls
• Laboratory Information System (LIS) interface parameters (refer to
Appendix A, LIS Interface)

Each part of system configuration is described in the following sections.


Section 7.8 contains worksheets for recording your system configuration
selections.

NOTES
• The Configure LIS Interface screen can be accessed at any time.
• New lots of calibrators/calibration controls and quality control samples can
be entered when the system is either in the READY or RUNNING modes.
However, lot information cannot be edited or deleted in the RUNNING mode.
• Excluding the above exceptions, all other system configuration screens can
only be accessed when the analyzer is in the READY or NOT READY mode.

3/00 © 2000 Copyright Beckman Coulter, Inc.


7-2 Rev 101740L Access Reference Manual
Introduction

System Configuration
1

System Lab. Tests Calib. Controls LIS About


Info. Interface Access

F1 F2 F3 F4 F5 F6 F7 F8

Figure 7-1 System Configuration Screen

[F1] System Displays the Configure System screen. Refer to Section 7.2.

[F2] Laboratory Displays the Laboratory Information screen. Refer to Section 7.4.
Information

[F3] Tests Displays the Configure Tests screen. Refer to Section 7.5.

[F4] Calibrators Displays the Configure Calibrators screen, which is used for entering
calibrators and calibration controls. Refer to Section 7.6.

[F5] Controls Displays the Configure Controls screen. Refer to Section 7.7.

[F6] LIS Displays the Configure LIS Interface screen. Refer to Appendix A, LIS
Interface Interface, for detailed information.

[F8] About Displays the About Access screen, which contains copyright and license
Access information about the Access Immunoassay System.

Table 7-2 System Configuration Screen Fields and Functions

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Access Reference Manual Rev 101740L 7-3
Configure System

7.2
Configure System
The first step in system configuration consists of configuring the following items
on the Configure System screen:
• Date and time formats
• Screen saver delay
• System date and time
• Auto Print Result Report option
• Free Thyroxine Index (FTI) ratio option
• Bar code reader/tube detector
• Language
• Printer (configure only for Japanese language).

Figure 7-5 is a flow chart of the configuration procedure.

NOTES
• To configure parameters for bar code reader symbologies, also refer to
Section 7.3, Configure Internal Bar Code Reader.
• The system supports Japanese language printers, which can be selected only
when the Language option is Japanese.

The Configure System Revisions screen, which is accessed by pressing the


[F8] Configure System Revisions key from the Configure System screen, allows
you to review the current revisions of your software and hardware. The screen is
automatically updated when a new revision of software is installed. For certain
hardware devices, the Access System can determine when the device is replaced,
and will automatically update the screen when a new revision of one of these
devices is installed. If a new revision of a hardware device is installed and the
screen is not automatically updated, the technical support representative
installing the device will update the screen with the new information.

3/00 © 2000 Copyright Beckman Coulter, Inc.


7-4 Rev 101740L Access Reference Manual
Configure System

Configure System
1

Date Auto Print


09-24-1999 Result Report After Trays

Time 05:32 pm FTI Ratio On

Date Format Bar Code Reader/ On


MM-DD-YYYY Tube Detector

Time Format 12 Hour Language English

Screen Saver 15 Printer HP Deskjet


Delay

Enter the current date in the format: MM-DD-YYYY.

Save Configure Configure


Bar Code System
Reader Revisions
F1 F2 F3 F4 F5 F6 F7 F8

Figure 7-3 Configure System Screen

Date The current date, which shows on displays and reports. This date conforms
to the format selected in the Date Format field.

Auto Print Result Indicates whether result reports automatically print when tests are
Report complete. Options are:
• After Samples, which sets the Sample Report to print when all tests for
a sample are either completed or cancelled
• After Trays, which sets the Tray Report to print when all tests for all
samples on a tray are either completed or cancelled
• Off, which prevents automatic printing of result reports. You can
manually print reports instead.

Refer to Section 5.3 in the Operator’s Guide for details on the result reports.

Time The current time, which shows on displays and reports. This date conforms
to the format selected in the Time Format field.

Table 7-4 Configure System Screen Fields and Functions

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 7-5
Configure System

FTI Ratio Indicates whether or not the system calculates the FTI ratio for samples with
valid Total T4 and Thyroid Uptake results. If configured on, the ratio
displays on the View Test Results screen and prints on reports.

Date Format The format in which dates are displayed and entered throughout the
system. Options are MM-DD-YYYY, DDMMMYYYY, or DD-MM-YYYY,
where D represents the numeric day, M represents the numeric month, and
Y represents the numeric year.

Bar Code Reader Configures the internal bar code reader and tube detector on or off. When
/Tube Detector the Bar Code Reader/Tube Detector is configured on, the internal bar code
reader scans the loaded sample tray for the Tray ID and for Sample IDs. To
enable available parameters for the CODABAR, Interleaved 2 of 5, or
CODE 39 bar code symbologies, press [F7] Configure Bar Code Reader.

Time Format The format in which time is displayed and entered throughout the system.
Options are 12 hour (with am and pm) or 24 hour.

Language The Language in which the system displays and prints. In addition to the
default language of English, you can configure the Access System in other
available languages, including:
• French
• German
• Italian
• Japanese
• Spanish

Screen Saver The number of minutes of system inactivity after which the screen saver
Delay activates, turning the screen black. The Access screen displays again and the
delay timer is reset when you press any key or when the system mode
changes, an icon is highlighted, or the reaction vessel load door is opened. If
the delay is set to 0 minutes, the screen saver does not activate.

Printer The system supports Japanese language printers, which can be selected only
when the Language option is Japanese.

[F1] Save Saves changes made on this screen. To activate some changes, you also need
to reboot the system.

[F7] Configure Displays the Configure Bar Code Reader screen. This key is available only
Bar Code when the Bar Code Reader/Tube Detector is configured on. Refer to Section
Reader 7.3, Configure Internal Bar Code Reader, for detailed information.

[F8] Configure Displays the Configure System Revisions screen. This screen is reserved for
System use by your technical support representative.
Revisions

Table 7-4 Configure System Screen Fields and Functions (continued)

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7-6 Rev 101740L Access Reference Manual
Configure System

Configure System

Main
Menu

[F8] System Config.

System
Configuration

[F1] System

Configure
System

Type new date, then [Enter]

[Space Bar] to scroll to desired Auto Print Result Report option, then [Enter]

Type new time, then [Enter]

[Space Bar] to toggle FTI Ratio on or off, then [Enter]

[Space Bar] to scroll to desired date format, then [Enter]

[Space Bar] to toggle Bar Code Reader/Tube Detector on or off, then [Enter] *

[Space Bar] to scroll to desired time format, then [Enter]

[Space Bar] to scroll to desired language, then [Enter]**

Type desired number of minutes for screen saver delay (1 to 99), then [Enter]

[Space Bar] to scroll to desired Japanese printer (for Japanese language only)**
[F1] Save
Save window opens. Ensure YES is highlighted, then [Enter]

System
Configuration

[F9] Main Menu

Main
Menu

* To enable available bar code symbology parameters, toggle on, then


[F7] Configure Bar Code Reader.
** If the language or Japanese language printer is changed, the system must be
rebooted after saving the configuration.
Note: Alternatively, use the [Arrow] keys to move from field to field.
Figure 7-5 Configure System Parameters Flow Chart
© 2000 Copyright Beckman Coulter, Inc. 3/00
Access Reference Manual Rev 101740L 7-7
Configure System

Entering Verify that the date displayed is correct. To change the date:
Current Date
1 Press [F8] System Config.

The System Configuration screen is displayed.

2 Press [F1] System.

The Configure System screen is displayed with the cursor in the Date field.

3 Type the current date using the format displayed in the Date Format field,
then press [Enter].

The new date is automatically saved and the cursor moves to the Auto Print
Result Report field.

Selecting 4 Press the [Space Bar] to scroll to the desired option, then press [Enter] to
Auto Print select.
Result Report
The cursor moves to the Time field.

Entering Verify that the time displayed is correct. To change the time:
Current Time
5 Type the current time using the time format displayed in the Time Format
field, then press [Enter].

The new time is automatically saved and the cursor moves to the FTI Ratio
field.

Selecting FTI 6 Press [Space Bar] to toggle the FTI Ratio option ON or OFF, then press
Ratio [Enter] to select.

The cursor moves to the Date Format field.

Selecting 7 Press [Space Bar] to scroll to the desired date format, then press [Enter] to
Date Format select.

The cursor moves to the Bar Code Reader/Tube Detector field.

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7-8 Rev 101740L Access Reference Manual
Configure System

Selecting
Bar Code NOTE
Reader/Tube The bar code reader should always be on, unless it is malfunctioning. If it is
Detector malfunctioning, call Technical Support immediately.

8 Press [Space Bar] to toggle the Bar Code Reader/Tube Detector option on or
off, then press [Enter] to select.

The cursor moves to the Time Format field.

• To enable or change bar code parameters to match the symbology of your


sample bar codes, press [F7] Configure Bar Code Reader when the bar code
reader is configured on. Refer to Section 7.3 for more information on
enabling bar code parameters.

Selecting 9 Press [Space Bar] to scroll to the desired time format (12- or 24-hour format),
Time Format then press [Enter] to select.

The cursor moves to the Language field.

Selecting 10 Press [Space Bar] to scroll to the desired language, then press [Enter] to
Language select.

NOTES
• To implement a new language, the system must be rebooted after the
system is configured (refer to Section 6.6, System Reboot for
instructions).
• If you select and configure a language in error and cannot determine
which language you want, call Technical Support for assistance in
changing to an appropriate language.

• The system displays screen and field names and prints report fields in
the language selected. However, regardless of the language selected,
the operator enters information using a standard English keyboard.

The cursor moves to the Screen Saver Delay field.

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Access Reference Manual Rev 101740L 7-9
Configure System

Defining 11 Type the desired number of minutes (1-99), or type 0 to disable the option,
Screen Saver then press [Enter] to select.
Delay
The cursor moves to the Printer field.

Selecting a This option is available only when Japanese is selected in the Language field.
Japanese When any other language is selected in the Language field, the default HP Deskjet
Language printer is displayed, and cannot be changed.
Printer
12 Press [Space Bar] to scroll to the desired Japanese language printer, then
press [Enter] to select.

NOTES
• To implement a new Japanese language printer, the system must be
rebooted after the system is configured (refer to Section 6.6, System
Reboot for instructions).
The cursor moves to the Date field.

Saving The date and time are automatically saved when they are entered. To save
Changes changes to the remainder of the configure system options:

13 Press [F1] Save.

A confirmation message is displayed.

14 Ensure that YES is highlighted, then press [Enter] to save changes.

The System Configuration screen is displayed. Continue system


configuration as needed.

3/00 © 2000 Copyright Beckman Coulter, Inc.


7-10 Rev 101740L Access Reference Manual
Configure Internal Bar Code Reader

7.3
Configure Internal Bar Code
Reader
When the internal bar code reader is configured on, it reads supported bar code
symbologies on sample tubes and trays. You can choose what encoded
information is included in the sample ID, such as check digits or start/stop
characters, by enabling or disabling available bar code parameters. Available
parameters and their successful programming depend on the
• Bar code symbology used.
• Internal bar code reader installed.

The Access System uses bar code symbology CODE 128 for tray labels. No
parameter choices are available for CODE 128 symbology.

Table 7-6 identifies available choices for supported bar code symbologies, sorted
by installed bar code reader. If you are not sure which parameters you need to
enable, consult the manufacturer’s bar code printer documentation or contact the
supplier of your printed bar code labels.

When you have identified your configuration choices, use the Configure Bar Code
Reader screen to configure the internal bar code reader.

NOTE
The bar code parameters configured for the Access System must match the
parameters of the printed bar code labels you use. If, after consulting your bar
code printer information, you cannot identify which bar code or bar code
parameters you need to configure, contact Technical Support.

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 7-11
Configure Internal Bar Code Reader

Bar Code Table 7-6 lists the available parameters for supported internal bar code
Symbology symbologies, sorted by internal bar code reader. Definitions of the bar code
Parameters parameters are included below the table.

Check Digit Send Number of


Reader/
Start/Stop Characters in the
Symbology
Enable Send Characters Bar Code to Send

Original Internal Bar Code Reader

Interleaved yes / no yes / no* not even number


2 of 5 available from 4 to 14

CODABAR yes / no yes / no* yes / no* not specified

CODE 39 yes / no yes / no* yes / no* not specified

Wide Scan Internal Bar Code Reader

Interleaved yes †/ no yes / no † not odd or even number


2 of 5 available from 4 to 15 †

CODABAR yes / no yes / no yes / no not specified

CODE 39 yes / no yes / no yes / no not specified

Table 7-6 Available Bar Code Parameters Sorted by Bar Code Reader
* For all symbologies with the original bar code reader, the send feature cannot
be disabled by configuration. If either a check digit or start/stop characters are
used in the bar code, the check digit or start/stop characters are sent. Disabling
the send parameter has no effect.
† For Interleaved 2 of 5, the bar code must be an even number of characters.
However, with the wide scan bar code reader, if you enable the Check Digit, but
do not enable the Check Digit Send field, an odd number of characters are
required, from 5 to 15.

Check Digit – Enable


Some bar code technologies can add a check digit to the bar code, which is
calculated using a standard formula applied to the characters of digits encoded in
the bar code. The check digit supplies a higher degree of data integrity than when
a check digit is not used. When it is used, the internal bar code reader also
calculates the check digit and verifies that the scanned bar code matches the
calculation. If the scanned bar code does not match, the Access System does not
accept the scanned bar code.

10/01 © 2001 Beckman Coulter, Inc.


7-12 Rev 101740R Access Reference Manual
Configure Internal Bar Code Reader

WARNING
Avoid using the combination of no check digit with the less accurate
symbologies, such as Interleaved 2 of 5 and CODABAR.

Check Digit – Send


When a calculated check digit is included in a bar code symbology, the wide scan
internal bar code reader can send that digit to the system or it can hide the digit. If
the check digit is sent, it shows on screens and reports as part of the Sample ID.

Send Start and Stop Characters


All bar code symbologies add characters to the bar code to indicate where the bar
code information starts and stops. If the start and stop characters are sent, they
show on screens and reports as part of the Sample ID.

Number of Characters in the Bar Code to Send


Bar code symbologies generally require that the number of characters in the bar
code fall within an allowed range. For some symbologies, the Access System
requires that within the allowed range, a fixed number of characters be
configured to send. The number of characters sent must fall within the
requirements of the number of characters in the Sample ID field, included on
screens and reports.

© 2001 Beckman Coulter, Inc. 10/01


Access Reference Manual Rev 101740R 7-13
Configure Internal Bar Code Reader

Configure Bar Code Reader


1

Interleaved CODABAR CODE 39


2 of 5

Check Digit No Check Digit No Check Digit No


Enable Enable Enable
Check Digit Check Digit No Check Digit
No Send Enable No
Send Enable Send Enable
Number of Start/Stop No Start/Stop No
10 Send Enable Send Enable
Characters

Press the [Space Bar] to toggle the sending of the start/stop chars.

Save

F1 F2 F3 F4 F5 F6 F7 F8

Figure 7-7 Configure Bar Code Reader Screen

Interleaved 2 of 5 The two bar code symbology parameters that can be enabled or disabled,
and the number of characters to send for Interleaved 2 of 5 symbology.

CODABAR The three bar code symbology parameters that can be enabled or disabled
for CODABAR symbology.

CODE 39 The three bar code symbology parameters that can be enabled or disabled
for CODE 39 symbology.

[F1] Save Saves changes made on this screen.

Table 7-8 Configure Bar Code Reader Screen Fields and Functions

10/01 © 2001 Beckman Coulter, Inc.


7-14 Rev 101740R Access Reference Manual
Configure Internal Bar Code Reader

Enabling Bar The Configure Bar Code Reader screen is displayed when the internal bar code
Code reader is configured on and you press [F7] Configure Bar Code Reader on the
Symbology Configure System screen. You can enable parameters for three available
Parameters symbologies.

The cursor begins in the Interleaved 2 of 5 column. If you do not need to enable or
change the Interleaved 2 of 5 parameters, press [Enter] or [Tab] to move the
cursor to the column of your choice. When you are done enabling parameters,
save the configuration.

Enabling Interleaved 2 of 5 Parameters


You can enable the Interleaved 2 of 5 check digit parameters or change the
number of characters to send. To enable Interleaved 2 of 5 parameters:

1 Press the [Space Bar] to toggle the Check Digit Enable field to Yes. Then
press the [Down Arrow] key to move the cursor to the next
Interleaved 2 of 5 field.

2 Press the [Space Bar] to toggle the Check Digit Send Enable field to Yes.
Then press the [Down Arrow] key to move the cursor to the next
Interleaved 2 of 5 field.

NOTES
• The Check Digit Send Enable field can only be enabled if the Check
Digit Enable field is enabled.
• The original internal bar code reader sends the check digit if it is
included in the bar code. Disabling the field does not prevent the
check digit from being sent.

3 Type the number of characters of the bar code to show on screens and
reports in the Number of Characters field.

NOTE
For Interleaved 2 of 5, the bar code must be an even number of characters.
However, for the wide scan bar code reader only, the number of characters
must be an odd number if the check digit is not sent.

• If you are configuring other symbologies or their parameters, press [Enter]


or [Tab] or the [Arrow] keys to move the cursor to the column of your
choice.

© 2001 Beckman Coulter, Inc. 10/01


Access Reference Manual Rev 101740R 7-15
Configure Internal Bar Code Reader

Enabling CODABAR Parameters


You can enable one or more of the CODABAR parameters. To enable CODABAR
parameters:

1 Press the [Space Bar] to toggle the Check Digit Enable field to Yes. Then
press the [Down Arrow] key to move the cursor to the next CODABAR field.

2 Press the [Space Bar] to toggle the Check Digit Send Enable field to Yes.
Then press the [Down Arrow] key to move the cursor to the next CODABAR
field.

NOTES
• The Check Digit Send Enable field can only be enabled if the Check
Digit Enable field is enabled.
• The original internal bar code reader sends the check digit if it is
included in the bar code. Disabling the field does not prevent the
check digit from being sent.

3 Press the [Space Bar] to toggle the Start/Stop Send Enable field to Yes.

NOTE
The original internal bar code reader sends the start/stop characters if they
are included in the bar code. Disabling the field does not prevent the
characters from being sent.

• If you are configuring other symbologies or their parameters, press [Enter]


or [Tab] or the [Arrow] keys to move the cursor to the column of your
choice.

Configuring CODE 39
You can enable one or more of the CODE 39 parameters. To enable CODE 39
parameters:

1 Press the [Space Bar] to toggle the Check Digit Enable field to Yes. Then
press the [Down Arrow] key to move the cursor to the next CODE 39 field.

2 Press the [Space Bar] to toggle the Check Digit Send Enable field to Yes.
Then press the [Down Arrow] key to move the cursor to the next CODE 39
field.

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7-16 Rev 101740R Access Reference Manual
Configure Internal Bar Code Reader

NOTES
• The Check Digit Send Enable field can only be enabled if the Check
Digit Enable field is enabled.
• The original internal bar code reader sends the check digit if it is
included in the bar code. Disabling the field does not prevent the
check digit from being sent.

3 Press the [Space Bar] to toggle the Start/Stop Send Enable field to Yes.

Saving the Configuration


To save the changes made to the internal bar code reader configuration:

1 Press [F1] Save.

A confirmation message is displayed.

2 Be sure that YES is highlighted, then press [Enter] to save the configuration.

The system takes 40 seconds to program the internal bar code reader
changes and when done, the Configure Bar Code Reader screen is displayed.

Disabling Bar Code Symbology Parameters


To disable any parameter:

1 Press [Enter] or [Tab] or the [Arrow] keys to move the cursor to the field of
the bar code symbology parameter to be disabled.

2 Press the [Space Bar] to toggle the field to No.

3 Save the configuration (press [F1] Save as described in the previous section).

© 2001 Beckman Coulter, Inc. 10/01


Access Reference Manual Rev 101740R 7-17
Configure Laboratory Information

7.4
Configure Laboratory
Information
Laboratory information can be entered into System Configuration for inclusion on
reports. Figure 7-9 is a flow chart of this procedure. The laboratory information is
included at the top (in the header) of every report generated.

All fields in the Laboratory Information screen are optional. If a field is left blank,
reports will not contain that information. Refer to Chapter 5 of the Operator’s
Guide for an example of a report containing laboratory information.

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7-18 Rev 101740L Access Reference Manual
Configure Laboratory Information

Configure Laboratory Information

Main
Menu

[F8] System Config.

System
Configuration

[F2] Lab Info.

Laboratory
Information

Type institution name, then [Enter]

Type laboratory name, then [Enter]

Type first line of address, then [Enter]

Type second line of address, then [Enter]

Type laboratory director name, then [Enter]

Type system identification, then [Enter]

Type technologist name, then [Enter]

Type other text, then [Enter]


[F1] Save
Ensure YES is highlighted, then [Enter]

System
Configuration

[F9] Main Menu

Main
Menu

Note: All fields in the Laboratory Information screen are optional.


Use the [Arrow] keys or [Enter] to move to the next field.

Figure 7-9 Configure Laboratory Information Flow Chart

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Access Reference Manual Rev 101740L 7-19
Configure Laboratory Information

Entering 1 Press [F8] System Configuration from the Main Menu.


Institution The System Configuration screen is displayed.
Name
2 Press [F2] Lab. Info.

The Laboratory Information screen is displayed.

3 Type the name of the institution (maximum 40 alphanumeric characters),


then press [Enter].

The cursor moves to the Lab Name field.

Entering Lab 4 Type the name of the laboratory (maximum 40 alphanumeric characters),
Name then press [Enter].

The cursor moves to the Address 1 field.

Entering 5 Type the first line of the address (maximum 40 alphanumeric characters),
Address then press [Enter].

The cursor moves to the Address 2 field.

6 Type the second line of the address (maximum 40 alphanumeric characters),


then press [Enter].

The cursor moves to the Director field.

Entering 7 Type the name of the laboratory director (maximum 40 alphanumeric


Director characters), then press [Enter].
Name The cursor moves to the System ID field.

Entering 8 Type the system identification number such as the instrument serial number
System ID (maximum 40 alphanumeric characters), then press [Enter].

• If an LIS is connected to multiple instruments, and is sending test


requests to a specific instrument, this field must contain a system ID.
• If an LIS is connected to multiple instruments, and this field is blank, the
request will be sent to all instruments.

The cursor moves to the Technologist field.

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7-20 Rev 101740L Access Reference Manual
Configure Laboratory Information

Entering 9 Type the name of the laboratory technologist (maximum 40 alphanumeric


Technologist characters), then press [Enter].
Name
The cursor moves to the Other Text field.

Entering Other Additional comments may be entered for inclusion on reports.


Text
10 Type the additional text (maximum 40 alphanumeric characters), then press
[Enter].

The cursor moves to the Institution field.

Saving When the laboratory information is entered:


Changes
11 Press [F1] Save.

A confirmation message is displayed.

12 Ensure that YES is highlighted, then press [Enter] to save changes.

The System Configuration screen is displayed. Continue system


configuration as needed.

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Access Reference Manual Rev 101740L 7-21
Configure Tests

7.5
Configure Tests
Tests can be configured for use in your laboratory. Figure 7-12 is a flow chart of
this procedure. The Configure Tests screen allows you to:
• Determine which tests are enabled (these tests are displayed in the Test
Menu window)
• Assign each test a Test ID that is used to select the test
• Define the following for each test: default sample type, reference and critical
ranges (quantitative and semi-quantitative assays only), units (quantitative
assays only), and gray zone (qualitative assays only).

Refer to Figure 7-10 and Table 7-11 for an example and description of the
Configure Tests screen.

The system sorts tests in the Configure Tests screen according to whether they are
enabled or disabled, then by Test ID. A test that has a reagent pack lot number
defined (i.e., in reagent inventory) cannot be disabled. The Test ID also affects the
test result printing order on tray reports. Test results are printed from lowest to
highest Test ID within each sample position. Therefore, you can assign Test IDs in
the order you want the test results to be printed on the tray report.

When assigning Test IDs, the system verifies that each Test ID is unique when you
press [F1] Save, [F2] Sort, or [Esc]. If you have two tests with the same Test ID
assigned, a message will be displayed, and you will not be allowed to save
changes until all Test IDs are unique.

For each quantitative test/sample type, units can be selected. If the units are
changed, the system automatically updates stored data (i.e., results, reference
ranges, critical ranges, control limits) to reflect the changes for that test/sample
type combination.

Reference range checking and critical range checking are only performed for
quantitative and semi-quantitative assays. Reference ranges are used to flag a
result that does not fall within the expected range. Upper and/or lower range

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7-22 Rev 101740L Access Reference Manual
Configure Tests

limits may be specified for each test/sample type combination, and the results
that are outside of these limits are flagged. When only one limit (for example, the
upper limit) is defined, the system checks the result against that limit, but does
not perform checking on a lower limit. When neither limit is defined, reference
range checking is not performed for that test/sample type combination. A result
that is below the lower limit is flagged ORL on reports. A result that is above the
upper limit is flagged ORH on reports.

Critical ranges are an additional range of values that operate identically to


reference ranges. A result that is below the lower limit is flagged CRL on reports.
A result that is above the upper limit is flagged CRH on reports. When the limits
are saved, the entry is converted to the number of decimal places defined in the
Configure Units screen.

Gray zone checking is performed only for qualitative assays. The gray zone is
used to flag a result that falls between the reactive low limit and the non-reactive
high limit. A result that is within the gray zone is flagged GRY on reports. If a
gray zone is recommended for an assay, the appropriate information is included
in the product insert. The gray zone limits for qualitative assays are entered as
decimal percentages of the cutoff value (for example, 0.95 is 95% of the cutoff).
The range of acceptable values is 0.8 to 1.2. To turn off gray zone checking, set
both limits to 1.0.

Some of the semi-quantitative assays support both a quantitative result and semi-
quantitative class scoring. The quantitative result will always be reported, but the
semi-quantitative class scoring can be suppressed. The assay protocol file defines
for what tests this option is available. If the option is available for a test, the
[F7] Toggle Result Type function key in the Configure Tests screen is displayed in
black when that test is highlighted. If the option is not available, the function key
is displayed in gray.

CAUTION
The Special Configuration option is intended for Beckman Coulter support
personnel and for future applications. Do not access this option unless
instructed by a technical support representative.

Some assays allow you to configure specific parameters. The Assay Protocol File
defines which tests support this option. If the option is available for a test, the [F8]
Special Config key is displayed in black when the test is highlighted on the
Configure Tests screen. If the option is not available, the [F8] Special Config key
is displayed in gray.

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Access Reference Manual Rev 101740L 7-23
Configure Tests

Configure Tests
1
Contact your Access representative for test availability.

Enabled Name Test Test ID Default Antigen Reflex


Tests Enabled Sample Type Excess Testing
45 Chl-Ag Yes 101 Other
Rub-IgG Yes 102 Serum
Rub-IgM Yes 103 Serum
Toxo-IgM Yes 105 Serum
HIV Yes 106 Serum
FT4 Yes 111 Serum
hFSH Yes 115 Serum
TBhCG2 Yes 151 Serum
Selected Test TotT3 Yes 166 Serum
Result Type
TSH Yes 183 Serum
IgG-Toxo Yes 200 Serum

Press the [Space Bar] to enable/disable the Test ID.


Save Sort Configure Configure Configure Configure Toggle Special
Reference Critical Units Gray Zone Result Config
Ranges Ranges Type
F1 F2 F3 F4 F5 F6 F7 F8

Figure 7-10 Configure Tests Screen

Enabled Tests The number of tests that are enabled and will be displayed in the
system.

Selected Test Semi-Quantitative (class scoring and quantitative result reported)


Result Type or Quantitative (class scoring suppressed and quantitative result
reported) for some semi-quantitative tests.

Name The test name (or abbreviated test name).

Test Enabled Yes (enabled) or No (disabled). Disabled tests are not displayed
on the Test Menu screen and cannot be selected during test
request entry.

Test ID The number assigned to the test for test selection during test
request entry.

Default Sample The sample type that is automatically displayed when the test is
Type selected during test request entry. The default may be overridden.

Antigen Excess This column is blank. Antigen excess testing is currently not
implemented.

Table 7-11 Configure Tests Screen Fields and Functions

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7-24 Rev 101740L Access Reference Manual
Configure Tests

Reflex Testing This column is blank. Reflex testing is currently not implemented.

[F1] Save Saves any changes made to test configuration.

[F2] Sort Sorts the tests according to Test ID. Any changes to the Test ID will
be reflected.

[F3] Reference (Cursor on a quantitative or semi-quantitative test name) - Opens


Ranges the Configure Reference Ranges screen which allows reference
ranges to be defined for each test/sample type combination.
(Cursor not on a quantitative or semi-quantitative test name) - Key
is light gray (non-selectable).

[F4] Critical (Cursor on a quantitative or semi-quantitative test name) - Opens


Ranges the Configure Critical Ranges screen which allows critical ranges
to be defined for each test/sample type combination.
(Cursor not on a quantitative or semi-quantitative test name) - Key
is light gray (non-selectable).

[F5] Units (Cursor on a quantitative test name) - Opens the Configure Units
screen which allows the units and number of decimal places to be
defined for each test/sample type combination.
(Cursor not on a quantitative test name) - Key is light gray (non-
selectable).

[F6] Gray Zone (Cursor on a qualitative test name) - Opens the Configure Gray
Zone screen which allows gray zone limits to be defined for
qualitative tests.
(Cursor not on a qualitative test name) - Key is light gray (non-
selectable).

[F7] Toggle Result (Cursor on a test name of a semi-quantitative test for which class
Type scoring can be suppressed) - Allows reporting or suppressing of
class scoring for some semi-quantitative tests.
(Cursor not on a test name of a semi-quantitative test for which
class scoring can be suppressed) - Key is light gray (non-
selectable).

[F8] Special Config This option is intended for authorized Beckman Coulter support
personnel and for future applications. Do not access this option
unless instructed by a technical support representative.

Table 7-11 Configure Tests Screen Fields and Functions (continued)

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Access Reference Manual Rev 101740L 7-25
Configure Tests

Configure Tests

Main Menu

[F8] System Config.


System
Configuration

[F3] Tests

Configure Tests

[Arrow] to desired test name

[Space Bar] to toggle test enabled (Yes) or disabled (No), then [Enter]

Type unique Test ID, then [Enter]—Or, [Enter] to accept default Test ID

[Space Bar] to scroll to desired sample type, then [Enter]


[F5] Units (quantitative assays only)
Type number of decimal places to display, then [Enter] to select

Repeat for all sample types, then [F1] Save

[F3] Reference Ranges and/or [F4] Critical Ranges

[Space Bar] to scroll to desired sample type, then [Enter]

Type lower limit of range, then [Enter]

Type upper limit of range, then [Enter]

Repeat for all sample types, then [F1] Save


[F6] Gray Zone (qualitative assays only)
Type lower limit of range, then [Enter]

Type upper limit of range, then [F1] Save

[Arrow] to test name with semi-quantitative class scoring toggle (optional)


[F7] Toggle Result Type (semi-quantitative
[F1] Save assays only)
System
Configuration

[F9] Main Menu


Main Menu

Figure 7-12 Configure Tests Flow Chart

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7-26 Rev 101740L Access Reference Manual
Configure Tests

Enabling 1 Press [F8] System Config. from the Main Menu.


(or Disabling)
The System Configuration screen is displayed.
Test
2 Press [F3] Tests.

The Configure Tests screen is displayed.

3 Use the [Up Arrow] or [Down Arrow] keys to highlight the desired test.

4 Use the [Space Bar] to toggle the test enabled (YES) or disabled (NO), then
press [Enter] to select.

The cursor moves to the Test ID field.

NOTE
A test cannot be disabled if a reagent pack is defined for that test. Remove the
reagent pack from inventory, then disable the test.

Entering Test 5 Type the unique Test ID (1-999), then press [Enter].
ID
The cursor moves to the Default Sample Type field.

• Alternatively, press [Enter] to accept the default Test ID.

Entering 6 Use the [Space Bar] to scroll to the desired sample type, then press [Enter]
Default to select.
Sample Type
The cursor moves to the Test Enabled field of the next test.

Sorting Tests • Press [F2] Sort.

The system sorts the test list. Any changes you have made will be reflected
in the new test list.

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Access Reference Manual Rev 101740L 7-27
Configure Tests

Selecting 7 Use the [Up Arrow] or [Down Arrow] keys to highlight the desired
Units for quantitative test.
Quantitative
8 Press [F5] Units.
Tests
The Units Setup screen is displayed.

9 Use the [Up Arrow] or [Down Arrow] keys to highlight the Units field for
the desired sample type.

10 Use the [Space Bar] to scroll to the desired units, then press [Enter] to select.

The cursor moves to the Decimal Places field.

11 Type the desired number of decimal places (0, 1, 2, or 3) to display for the
result value, then press [Enter].

12 When all sample types display the desired units and decimal places, press
[F1] Save.

The Configure Tests screen is displayed.

Entering 13 Use the [Up Arrow] or [Down Arrow] keys to highlight the desired
Reference quantitative or semi-quantitative test.
Ranges
14 Press [F3] Ref. Ranges.

The Reference Ranges Setup screen for the test is displayed with the cursor
in the Sample Type field.

15 Use the [Space Bar] to scroll to the desired sample type, then press [Enter]
to select.

The cursor moves to the Lower Limit field.

16 Type the lower limit of the reference range (maximum 10 numeric


characters, decimal point counts as 1 character), then press [Enter].

The cursor moves to the Upper Limit field.

17 Type the upper limit of the reference range (maximum 10 numeric


characters, decimal point counts as 1 character), then press [Enter].

18 When reference ranges are defined for all desired sample types, press
[F1] Save.

The Configure Tests screen is displayed.

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Configure Tests

Entering 19 Use the [Up Arrow] or [Down Arrow] keys to highlight the desired
Critical quantitative or semi-quantitative test.
Ranges 20 Press [F4] Critical Ranges.

The Critical Ranges Setup screen for the test is displayed with the cursor in
the Sample Type field.

21 Use the [Space Bar] to scroll to the desired sample type, then press [Enter]
to select.

The cursor moves to the Lower Limit field.

22 Type the lower limit of the critical range (maximum 10 numeric characters,
decimal point counts as 1 character), then press [Enter].

The cursor moves to the Upper Limit field.

23 Type the upper limit of the critical range (maximum 10 numeric characters,
decimal point counts as 1 character), then press [Enter].

24 When critical ranges are defined for all desired sample types, press
[F1] Save.

The Configure Tests screen is displayed.

Entering Gray 25 Use the [Up Arrow] or [Down Arrow] keys to highlight the desired
Zone for qualitative test.
Qualitative
26 Press [F6] Gray Zone.
Tests
The Gray Zone Setup screen is displayed.

27 Type the upper limit of the gray zone (maximum 1.2 which is 120%), then
press [Enter]. The value must be a maximum of 6 numeric characters where
a decimal point is 1 character.

28 Type the lower limit of the gray zone (minimum 0.8 which is 80%), then
press [Enter]. The value must be a maximum of 6 numeric characters where
a decimal point is 1 character.

29 Press [F1] Save.

The Configure Tests screen is displayed.

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Access Reference Manual Rev 101740L 7-29
Configure Tests

Enabling (or 30 Use the [Up Arrow] or [Down Arrow] keys to highlight the desired semi-
Disabling) quantitative test.
Optional The current selection (i.e., Quantitative or Semi-Quantitative) for the test is
Semi- displayed in the Selected Test Result Type field.
Quantitative
Class Scoring 31 Press [F7] Toggle Result Type to toggle the selection to Quantitative or
Semi-Quantitative.

If you select ... Then ...

Quantitative Only the quantitative result is reported

Semi-Quantitative Both the quantitative result and semi-


quantitative class scoring are reported

Saving When the test configuration information is entered:


Changes
32 Press [F1] Save.

A confirmation message is displayed.

33 Ensure that YES is highlighted, then press [Enter] to save changes.

The System Configuration screen is displayed. Continue system


configuration as needed.

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7-30 Rev 101740L Access Reference Manual
Configure Calibrators and Calibration Controls

7.6
Configure Calibrators and
Calibration Controls
Each new lot of a calibrator (for quantitative and semi-quantitative assays) or a
calibration control (for qualitative assays) is entered into the system in System
Configuration before it can be selected during test request entry. Figure 7-15 is a
flow chart of this procedure. Calibrators and calibration controls are added in the
Add Calibrator Lot screen (refer to Figure 7-13 and Table 7-14), which is accessed
by pressing [F4] Calib. from the System Configuration screen, then [F1] Add Lot
from the Configure Calibrator screen.

Each calibrator has a “calibrator set” bar code which contains the following
information:
• Calibrator set name (test ID)
• Calibrator set lot number
• Calibrator set expiration date

In addition, calibrator sets have one or more “calibrator levels,” each of which has
a calibrator level bar code containing the following information:
• Calibrator level (i.e., S0, S1, S2)
• Stated concentration
• Test name (test ID)

Calibrator set bar codes and calibrator level bar codes are located on the
“calibration card” included in each calibrator kit.

Each calibration control has a calibration control bar code which contains the
following information:
• Calibration control name (test ID)
• Calibration control lot number
• Calibration control expiration date

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Access Reference Manual Rev 101740L 7-31
Configure Calibrators and Calibration Controls

Calibration control levels are included in the assay protocol. Therefore, when the
calibration control bar code is entered, the system automatically assigns all
appropriate calibration control levels. The calibration control bar code is located
on the “calibration card,” which is included with each calibration control set.

The calibrator set/level bar codes and calibration control bar codes can be
scanned into the system using the external bar code wand or they can be
manually entered by typing the bar code characters (letters and/or numbers
printed under the bar code) into the Bar Code Entry field of the Add Calibrator
Lot screen.

NOTE
If your system is configured in a language other than English or Japanese, it may
not always accept the bar coded calibrator card expiration date. The last 5
characters of the bar coded information are the expiration month and year,
formatted MMMYY, where MMM are the first three letters of the month in
English. To enter the information in your configured language, type the bar
coded calibrator information, substituting the first three letters of the month in
the configured language for the English letters. No substitution is required when
the first three letters of the month are the same in English and in the configured
language.

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Configure Calibrators and Calibration Controls

Add Calibrator Lot


1

Bar Code Entry Level Stated Conc. Units

S0 0.000 pg/mL
S1 100.000 pg/mL
S2 250.000 pg/mL
S3 500.000 pg/mL
S4 900.000 pg/mL
Calibrator Set Name VitCal S5 1500.000 pg/mL
Lot Number 900772
Expiration Date 28FEB00
Test VitB12

Scan or type the code for each level.

Save

F1 F2 F3 F4 F5 F6 F7 F8

Figure 7-13 Add Calibrator Lot Screen

Bar Code Entry The characters received from the external bar code wand when a bar
code label is scanned for the calibrator set bar code, calibrator level bar
code, or calibration control bar code. These characters can also be typed
into the field.

Calibrator Set The abbreviation of the calibrator name or calibration control name is
Name displayed automatically when the calibrator set bar code or calibration
control bar code is entered.

Lot Number The lot number of the calibrator or calibration control is displayed
automatically when the calibrator set bar code or calibration control bar
code is entered.

Expiration Date The date on which the calibrator or calibration control expires is
displayed automatically when the calibrator set bar code or calibration
control bar code is entered.

Test The test name is displayed automatically when the calibrator level bar
code or calibration control bar code is entered.

Table 7-14 Add Calibrator Lot Screen Fields and Functions

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Access Reference Manual Rev 101740L 7-33
Configure Calibrators and Calibration Controls

Level The calibrator level is displayed when the calibrator level bar code is
entered. The calibration control levels are displayed automatically
when the calibration control bar code is entered.

Stated Conc. The stated concentration of the calibrator level is displayed


automatically when the calibrator level bar code is entered. For
calibration controls, Reactive or Non Reactive is displayed
automatically when the calibration control bar code is entered. For
confirmatory assays, Confirmed or Not Conf (Not Confirmed) is
displayed when the bar code is entered.

Units The units in which the concentration was calculated are displayed
automatically when the calibrator level bar code is entered.

[F1] Save Saves the calibrator or calibration control information.

Table 7-14 Add Calibrator Lot Screen Fields and Functions (continued)

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7-34 Rev 101740L Access Reference Manual
Configure Calibrators and Calibration Controls

Configure Calibrators

Main
Menu

[F8] System Config.

System
Configuration

[F4] Calib.

Configure
Calibrator

[F1] Add Lot

Add
Calibrator Lot

qualitative assays quantitative assays

Scan calibration control bar code* Scan calibrator set bar code*

Scan calibration control level bar code* Scan calibrator level bar code*

System automatically adds data System automatically adds


to table data to table More levels

More levels [F1] Save


A save window is displayed. Ensure YES is highlighted, then [Enter]
[Esc] More lots

[F9] Main Menu


Main
Menu

* The calibration control bar code, calibrator set bar code, and individual
calibration control level/calibrator level bar code(s) are located on the
calibrator/calibration card included in the calibration control/calibrator kit.
Alternatively, type the number under the bar code into the Bar Code Entry
field, then press [Enter].

Figure 7-15 Configure Calibrators Flow Chart

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Access Reference Manual Rev 101740L 7-35
Configure Calibrators and Calibration Controls

Entering 1 Press [F8] System Config. from the Main Menu.


Calibrator Set
The System Configuration screen is displayed.
or Calibration
Control Bar 2 Press [F4] Calib.
Code The Configure Calibrator screen is displayed.

3 Press [F1] Add Lot.

The Add Calibrator Lot screen is displayed with the cursor in the Bar Code
Entry field.

4 Scan the calibrator or calibration control set bar code located on the
calibration card.

Alternatively, the calibrator or calibration control set bar code may be manually
entered:

• Type the characters located directly under the bar code, then press [Enter].

The system automatically displays the calibrator or calibration control set


name, lot number, and expiration date. For qualitative assays, the system
also displays the calibration control levels, concentrations, units, and
test name.

NOTES
• The system will not accept entry of an expired calibrator or calibration
control.
• If your system is configured in a language other than English or Japanese, it
may not always accept the bar coded calibrator card expiration date. The last
5 characters of the bar coded information are the expiration month and year,
formatted MMMYY, where MMM are the first three letters of the month in
English. To enter the information in your configured language, type the bar
coded calibrator information, substituting the first three letters of the month
in the configured language for the English letters. No substitution is
required when the first three letters of the month are the same in English and
in the configured language.

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Configure Calibrators and Calibration Controls

Entering A bar code must be entered for each calibration control level/calibrator level.
Calibration Repeat the following steps until all levels are entered. The calibration control
Control Level/ levels/calibrator levels may be entered in any order.
Calibrator
5 Scan the calibration control level/calibrator level bar code located on the
Level Bar calibration card.
Code(s)
The system automatically displays the calibration control level/calibrator
level, concentration, units, and test.

Alternatively, the calibration control level/calibrator level bar code may be


manually entered:

• Type the number located under the calibration control level/calibrator level
bar code on the calibration card, then press [Enter].

The system automatically displays the calibration control level/calibrator


level, concentration, units, and test.

6 Repeat step 5 for each calibration control level/calibrator level.

Saving When all calibration information is entered:


Changes
7 Press [F1] Save.

A confirmation message is displayed.

8 Ensure that YES is highlighted, then press [Enter] to save changes.

9 Press [Esc].

The Configure Calibrator screen is displayed. Continue calibration


configuration as needed.

© 2000 Copyright Beckman Coulter, Inc. 3/00


Access Reference Manual Rev 101740L 7-37
Configure Controls

7.7
Configure Controls
Quality control system configuration consists of entering the following control
sample information:
• Control name
• Lot number
• Expiration date
• Sample type
• Expected mean (test specific)
• Expected standard deviation (test specific)

Control information is entered into system configuration for each new lot of a
control. Figure 7-18 is a flow chart of this procedure. Use a different control name
for each new lot number. The system does not limit the number of lots entered for
a control.

Quality control samples are tested like patient samples to assure the validity of
the patient sample results. Each laboratory should establish the acceptable range
for commercially available quality control materials. The manufacturer's
suggested ranges may be used until an adequate number of samples have been
processed to determine a lot specific mean and standard deviation.

QC rules are additional quality control functions that may be enabled to evaluate
and, if necessary, flag results. For example, you may choose to flag results that are
more than 3 SD from the mean. Refer to Figure 7-16 and Table 7-17 for an example
and explanation of the Add Control screen. Use of QC rules should be determined
by the laboratory supervisor before entering quality control information in
System Configuration. Refer to Section 3.4, Quality Control in this manual for a
description of the available QC rule selections.

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If you are using a multi-level control, each level is entered as a separate control. A
maximum of 250 control name/control lot number/Test ID combinations can be
entered into System Configuration. For example, if three tests are assigned to one
lot number of one control, three of the 250 available combinations are used. If a
second lot number of the control is added, and the three tests are assigned to that
lot number also, three more of the 250 available combinations are used.

Enter the control name exactly as you want it to appear on reports (maximum of 8
alphanumeric characters; spaces are not accepted). This control name can be
typed into the Sample ID field during test request entry to select the control for
processing. Control names must be unique; one control name cannot differ from
another only by upper or lower case (for example, if CONTROL1 exists as a
control name, Control1 will not be accepted as a different control). Control names
must also be unique for each lot number of the same control.

The expected, or fixed, mean and standard deviation are used to calculate the
standard deviation interval (SDI):

Result – (minus) Expected Mean

SDI =  (divided by)


Expected Standard Deviation

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Configure Controls

Add Control
1

Control Control Exp. Date 08-07-1996


Lot 321765 Sample Serum

QC Rules
Test Mean SD Units 1-2s 2-2s 1-3s 4-1s 10X
Ferritin 102.00 3.00 ng/mL on on on on off

Press the [Space Bar] to toggle each QC Rule on or off.

Save Add/
Delete
Test
F1 F2 F3 F4 F5 F6 F7 F8

Figure 7-16 Add Control Screen

Control The control name that is entered during test request entry.
Lot The control lot number.
Exp. Date The date on which the control expires.
Sample The sample type for the control. Serum, Urine, CSF, Blood, Plasma, or Other.
Test The abbreviation of the test name.
Mean The expected mean for the test.
SD The expected standard deviation for the test.
Units The units used for the test/sample type combination.
QC Rules QC rules (statistical analysis rules) selected for a test. Use the [Space Bar] to
toggle the rules on or off.
[F1] Save Saves any changes made to the screen.
[F2] Add/ Opens the Control Tests screen which allows you to specify the tests assigned to
Delete the control. When these tests are selected during test request entry, quality
Test control data and Levey-Jennings charts are generated for the tests.

Table 7-17 Add Control Screen Fields and Functions

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Configure Controls

Configure Controls

Main
Menu
[F8] System Config.
System
Configuration
[F5] Controls
Configure
Control
[F1] Add Control
Add
Control

Type control name, then [Enter]

Type control expiration date (accepted format displayed in prompt line), then [Enter]

Type control lot number, then [Enter]

Verify sample type. To change, press [Space Bar] to scroll to desired sample type,
then [Enter]
[F2] Add/Delete Test
Control
Tests

Type Test ID, then press [+]. Repeat until all tests are entered.
[Esc]

Add
Control

Type mean, then [Enter]

Type standard deviation, then [Enter]

Verify QC rule selections. To change, [Arrow] to rule, press


[Space Bar] to toggle the rule ON or Off, then [Enter] More tests
[F9] Main Menu
Save window opens, verify YES is highlighted, then [Enter]

Main
Menu

Figure 7-18 Configure Controls Flow Chart

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Entering 1 Press [F8] System Configuration from the Main Menu.


Control Name
The System Configuration screen is displayed.

2 Press [F5] Controls.

The Configure Control screen is displayed.

3 Press [F1] Add Control.

The Add Control screen is displayed with the cursor in the Control field.

4 Type the control name (maximum of 8 alphanumeric characters), then press


[Enter].

The cursor moves to the Exp. Date field.

Entering 5 Type the control sample expiration date (the accepted format is displayed in
Control the prompt line), then press [Enter].
Expiration
The cursor moves to the Lot field.
Date

Entering 6 Type the control sample lot number (maximum of 10 numeric characters),
Control Lot then press [Enter].
Number
The cursor moves to the Sample field.

Selecting 7 Press [Space Bar] to scroll to the desired sample type, then press [Enter] to
Control select.
Sample Type
The cursor remains in the Sample field.

Entering 8 Press [F2] Add/Delete Test to display the Control Tests screen.
Control Tests
9 Type the Test ID associated with the test, then press [+] to select the test.

• To delete a test, type the Test ID, then press [ - ].

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10 Repeat until all desired tests are selected, then press [Esc].

The Add Control screen is displayed with the test(s) and units filled in and
the cursor in the first empty Mean field.

Entering The expected mean for the control can be any decimal number (maximum of 10
Control Test numeric characters), but the number will be displayed with two decimal places.
Mean Negative numbers and zero are not accepted.

11 Type the expected mean, then press [Enter].

The cursor moves to the SD field.

Entering The expected standard deviation (SD) for the control can be any decimal number
Control (maximum of 10 numeric characters), but the number will be displayed with two
Standard decimal places. Negative numbers and zero are not accepted.
Deviation
12 Type the expected standard deviation, then press [Enter].

The cursor moves to the first QC Rules field.

Selecting QC The QC Rules are selected in the five QC Rules fields. The available QC rules
Rules options are the following:
• 12s (1-2s) - Flag when one point is more than 2 SD from the mean.

• 22s (2-2s) - Flag when 2 consecutive points of a given control are more
than 2 SD from the mean in the same direction. Only the
second point is flagged.
• 13s (1-3s) - Flag when one point is more than 3 SD from the mean.

• 41s (4-1s) - Flag when 4 consecutive points of a given control are more
than 1 SD from the mean in the same direction. Only the
fourth point is flagged.
• 10x (10x) - F