access immunoassay system manual

Access Immunoassay System

Reference Manual

Revision 101740S

Revised May 2003

Printed in U.S.A.

2003 Beckman Coulter, Inc.

BECKMAN COULTER, INC. FULLERTON, CA 92835

TM

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


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:


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.

2000 Copyright Beckman Coulter, Inc. 3/00Access Reference Manual Rev 101740L i

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 the Access Immunoassay System

Section Page

1.1 Technology Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2

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 Specifications and Performance Characteristics

Section Page

2.1 Space and Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2

2.2 Performance Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

Table of Contents

3/00 2000 Copyright Beckman Coulter, Inc.ii Rev 101740L Access Reference Manual

Theory of Operation

Section Page

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 Diagnostics

Section Page

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

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

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

Trouble-shooting

Section Page

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 Procedures

Section Page

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

2000 Copyright Beckman Coulter, Inc. 3/00Access Reference Manual Rev 101740L iii

Table of Contents

System Support Procedures (continued)

Section Page

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 Configuration

Section Page

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

Table of Contents

3/00 2000 Copyright Beckman Coulter, Inc.iv Rev 101740L Access Reference Manual

LIS Interface (continued)

Section Page

A.6 LIS Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-20

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

2000 Copyright Beckman Coulter, Inc. 3/00Access Reference Manual Rev 101740L v

List of Figures and Tables


Preface Table/Figure Page

Table P-1 Instrument Documentation in Available Languages . . . . . . . . . . . . . . 2

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


Table/Figure Page

Figure 1-1 System Functionality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

Figure 1-2 Top ViewRevision A Fluidics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

Figure 1-3 Top ViewRevision 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 ModuleRevision A Fluidics. . . . . . . . . . . . . . . . . . . 1-10

Figure 1-7 Main Pipettor ModuleRevision B Fluidics . . . . . . . . . . . . . . . . . . . 1-11

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

Figure 1-9 Fluidic ModuleRevision A Fluidics . . . . . . . . . . . . . . . . . . . . . . . . . 1-14

Figure 1-10 Fluidic ModuleRevision 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


3/00 2000 Copyright Beckman Coulter, Inc.vi Rev 101740L Access Reference Manual

Introduction to the Access Immunoassay System (continued)

Table/Figure Page

Table 1-20 Field to Field Key Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-29

Table 1-21 Within Field Key Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-29

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 Operation

Table/Figure Page

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 Diagnostics

Table/Figure Page

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

2000 Copyright Beckman Coulter, Inc. 3/00Access Reference Manual Rev 101740L vii


System Support Procedures

Table/Figure Page

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


3/00 2000 Copyright Beckman Coulter, Inc.viii Rev 101740L Access Reference Manual

System Support Procedures (continued)

Table/Figure Page

Figure 6-31 Primary Probe Assembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-80

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 Configuration

Table/Figure Page

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

2000 Copyright Beckman Coulter, Inc. 3/00Access Reference Manual Rev 101740L ix


LIS Interface (continued)

Figure A-3 Configure LIS Interface Flow Chart. . . . . . . . . . . . . . . . . . . . . . . . . . . A-5

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


3/00 2000 Copyright Beckman Coulter, Inc.x Rev 101740L Access Reference Manual

2000 Copyright Beckman Coulter, Inc. 3/00Access Reference Manual Rev 101740L 1

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 System Docu-mentation

The Access Immunoassay System documentation and the system software are provided in four, 3-ring binders:

Access Immunoassay System Operators 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)

Preface

3/00 2000 Copyright Beckman Coulter, Inc.2 Rev 101740L Access Reference Manual

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.

Operators GuideThe Operators 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 ManualThe 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 ManualThe 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 SoftwareA 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.

Document English French German Italian SpanishOperators Guide 81516 81526 81536 81546 81556

Reference Manual 81519 81529 81539 81549 81559

Table P-1 Instrument Documentation in Available Languages


Preface

Manual Conventions

The Access System manuals follow certain conventions, ensuring consistency 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:

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:

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

CAUTIONCautions are used when there is the possibility of damaging the analyzer.

NOTENotes are used to highlight or provide additional information.

1

Preface


Safety Features

The Access Immunoassay System analyzer is designed to meet U.S. and 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.


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.

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 SwitchIn 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.

WARNINGThe 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 AlarmThe 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.

2003 Beckman Coulter, Inc. 5/03Access Reference Manual Rev 101740S 7

Preface

Warranty Information

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

Responsibility during the Warranty PeriodThe customer is responsible for the routine preventive maintenance described in Chapter 8, Routine Maintenance of the Operators 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 customers expense.

Technical Support

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

Ordering Supplies

Table P-2 is a list of Access System manuals and supplies, and their respective catalog numbers. Also, available parts and tools that are referred to in the Operators 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.

Product Catalog 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(see also Primary Access Chlamydia Collection Kit)

973207

Access Chlamydia Insert Cups, 1.0 mL (1000) (Not needed if the primary Access Chlamydia Collection Kit is used.)

81916

Access Chlamydia Cup Caps (1000) 81921

Table P-2 Ordering Supplies

Preface

5/03 2003 Beckman Coulter, Inc.8 Rev 101740S Access Reference Manual

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:

Operators 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)

2003 Beckman Coulter, Inc. 5/03Access Reference Manual Rev 101740S 9

Preface

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 printers

81623

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, and 10 brushes)

80769

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 (1 sheet) for each type of sample container.

973052

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



Preface

5/03 2003 Beckman Coulter, Inc.10 Rev 101740S Access Reference Manual

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



* 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 yourlocal product inserts.

2000 Copyright Beckman Coulter, Inc. 3/00Access Reference Manual Rev 101740L 1-1


1Introduction 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

Technology Overview

3/00 2000 Copyright Beckman Coulter, Inc.1-2 Rev 101740L Access Reference Manual

1.1Technology 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.


Technology Overview

Processing Functions

Processing functions are performed by the following modules:

Carousel moduleThis module contains the samples to be processed and the specific assay reagent packs.

Main pipettor moduleThis 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 moduleThis 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 moduleThe 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 Functions

Control functions, which direct the operation of the processing modules, are 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.

Technology Overview


Interface Functions

Interface functions are performed by the system software, directed through the 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.

Figure 1-1 System Functionality

CAROUSEL MODULE Reagent Carousel Sample Carousel Internal Bar Code

Reader/Tube Detector

PROCESSING FUNCTIONS

MAIN PIPETTORMODULE

Main Pipettor Precision Pump Pipettor Gantry Ultrasonic Transducer

ANALYTICAL MODULE Reaction Vessel Loader Incubator Belt Wash/Read Carousel Luminometer

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

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

PERIPHERAL MODULE Keyboard Monitor Printer External Bar Code Wand External Bar Code Scanner

SystemSoftware

CONTROL FUNCTIONS

INTERFACE FUNCTIONS


Instrument Description

1.2Instrument 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.



Figure 1-2 Top ViewRevision A Fluidics

Figure 1-3 Top ViewRevision B Fluidics

Fluidic Module

Electronics Module

Carousel Module

Main Pipettor ModuleAnalytical Module

Electronics Module

Carousel ModuleMain Pipettor Module

Analytical Module

Fluidic Module



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

Revision A and BFluidics

There are two different revisions of the fluidic system used in the Access System. The main differences are in the fluidic and main pipettor modules. Some 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.

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 Module

Samples and reagent packs/vials on-board the analyzer are located on two 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.

400600 through 400604 400673 through 400678

400642 400760

400643 400770

400651 through 400659 400773

400664 400788

400665 400791

400668 400804 and higher



Figure 1-5 The Carousel Module

Sample CarouselThe 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 Operators Guide for details).

Internal Bar Code ReaderAfter 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.

Internal Bar Code Reader

Reagent Carousel

Sample Carousel

Sample Tray

Reagent Packs

Cup/Tube Detector



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.

NOTEFor 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 DetectorAfter 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 CarouselThe reagent carousel holds up to 24 reagent packs/vial racks.

NOTEVials and vial racks are not available in all areas.

The carousel temperature is maintained at 3 to 10C 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.



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.

MainPipettor Module

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

Figure 1-6 Main Pipettor ModuleRevision A Fluidics

Front View Front View

Pipettor GantryPrecision Pump

Main Pipettor

UltrasonicTransducer

Primary Probe

Note: Devices have been simplified for illustration purposes.

Top View



Figure 1-7 Main Pipettor ModuleRevision B Fluidics

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

Main PipettorThe 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 PumpThe 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.

Front View

Pipettor Gantry

Precision Pump Main Pipettor

UltrasonicTransducer

Primary Probe

Note: Devices have been simplifiedfor illustration purposes.

Top View



Ultrasonic TransducerThe 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 Module

The analytical module (Figure 1-8) is comprised of the reaction vessel supply, 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.

Figure 1-8 Analytical Module

Reaction Vessel LoaderThe 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.

Reaction Vessel Load Door

Reaction Vessel Loader

Luminometer

Wash/Read Carousel

ReactionVesselWasteBag

Wash Arm

Incubator Track and Belt



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 BeltThe 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 CarouselThe 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.



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

LuminometerThe 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 Module

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

Figure 1-9 Fluidic ModuleRevision A Fluidics

Fluids Tray

Probe Wash Tower

Substrate Valve

Substrate PumpWash Pump Waste Pump

Vacuum Reservoir

Waste Valve

VacuumPump

Substrate Heater

Wash Valve

Probe Wash Valve



Figure 1-10 Fluidic ModuleRevision B Fluidics

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

Wash Pump and ValveThe 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 ValveThe 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 ReservoirThe 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.

Probe Wash Tower

Substrate Valve,Pump, and Heater

Wash Pump

Peristaltic Waste Pump

Vacuum Reservoir

Vacuum Pump

Fluids Tray

Wash Valve

Probe Wash Valve

0051E



Substrate Pump, Valve, and HeaterThe substrate pump and valve dispense substrate, preheated in the substrate heater, through the substrate probe into the reaction vessels.

Probe Wash TowerThe 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 PumpDuring 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 TrayThere 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.

Figure 1-11 Unibase Fluids Tray

Float Level Sensor

Liquid Waste Bottle

Waste Filter/Bottle Assembly

Wash Buffer Bottle

Wash Buffer Reservoir

SubstrateBottles



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.

Figure 1-12 Original Fluids Tray

Liquid WasteBottle

Waste Filter/Bottle Assembly

Wash Buffer Bottle

Wash Buffer Reservoir



Electronics Module

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

Figure 1-13 Electronics Module

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

Power SupplyThe 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 DriveThe hard disk stores the system software and databases.

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

Power Supply(under PCBs)

Printed CircuitBoards (PCBs)

Hard Disk Drive Floppy Disk Drive

Reset Button



Interlock SwitchThe 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.

WARNINGThe 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 AlarmThe 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.



Peripheral Module

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

Figure 1-14 Peripheral Module

Color MonitorThe color monitor provides high resolution screen text and graphics.

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

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

PrinterThe single sheet feed printer produces letter quality reports and graphics. Refer to the printer manufacturers manual for details.

External Bar Code WandThe 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.

Printer

Color Monitor

Articulated Arm

Keyboard

External Bar Code Wand

External Bar Code Scanner



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.

NOTEVials 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

System Software


1.3System 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.


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.

System Software


Figure 1-15 Example Screen

System Mode

Screen Title

On-boardTrays

Dialog Window

Status IconsPrompt LineActiveFunction Keys

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


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 LogRefer 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 FunctionKeys

The active function keys, [F1] through [F8], are used to access the 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.

NOTEIn 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)

System Software


System Modes

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

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:

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

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


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 Vessels

The system monitors the number of reaction 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.

SupplyAction Required

The background of this icon turns red if the worklist being initiated cannot run to completion without operator 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 VesselWaste Bag

The system tracks the number of reaction vessels ejected into the reaction vessel waste bag. When there is room in 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)

System Software


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

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)

[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


System Software

Within Field Edit Keys

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

[Shift-Right Arrow]

Scrolls the field one character to the right if the entire field entry cannot be displayed.

[Shift-Left Arrow]

Scrolls the field one character to the left if the entire field entry cannot be 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

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.

Figure 1-22 Main Menu

[F1] TestRequest/ Progress

Select this option to enter sample information, select tests, review and edit the test requests, load or unload sample trays from the system, select LIS samples for processing, clear trays, or review testing progress. Refer to Chapter 3 of the Operators Guide for detailed information.

[F2] View Test Results

Select this option to review, print, and archive patient results, and send them to an LIS (refer to Appendix A for more information on the LIS interface). Refer to Chapter 5 of the Operators Guide for detailed information.

Table 1-23 Main Menu Active Function Keys

1 Main Menu

F1

F2

F3

F4 F5 F6 F7 F8

TestRequest/Progress

ViewTest

Results

Supplies QualityControlReview

Maint. Diag. System Config.

Calib.Review

This program is protected by U.S. and international lawsas described in About Access

Copyright Beckman Coulter, Inc. 200XVersion X.XX

TM

Access


System Software

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

[F4] QualityControlReview

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

[F5] Calibration Review

Select this option to review and print calibration data. Refer to Section 3.3, Calibration, of this manual and Chapter 6 of the Operators Guide for detailed information.

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

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

[F8] SystemConfiguration

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

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

System Assays


1.4System 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.


System Assays

Competitive Binding Assays

Figure 1-24 Competitive Binding Assays

Wash to remove unbound components.

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

Immune complexes form.

= Specific antibody directedagainst analyte

= Analyte in sample

= Conjugate (analyte coupled with alkaline phosphatase)

= Paramagnetic particle coated with capture antibody

= Reaction between substrate and conjugate produces lightdioxetanedioxetane-P

Legend

dioxetanedioxetane-P

Add substrate, incubate, and read. Amount of light measured is inversely proportional to the analyte concentration in sample.

= Wash 3 times

System Assays


Sandwich Assays

Figure 1-25 Sandwich Assays



Add substrate, incubate, and read. Amount of light measured is proportional to the analyte concentration in the sample.

= Analyte in sample

= Conjugate (antibody directed against the analyte, coupled with alkaline phosphatase)

= Paramagnetic particle coated with capture antibody and monoclonalantibody directed against the analyte

= Reaction between substrate and conjugate produces light


Legend

Mix paramagnetic particles, conjugate, and sample in the reaction vessel and incubate.


= Wash 3 times


System Assays

Antibody Detection Assays

Figure 1-26 Antibody Detection Assays

Wash to remove unboundcomponents.


Mix paramagnetic particles and sample in the reaction vessel and incubate.


Add conjugate and incubate.


Add substrate, incubate and read. Amount of light measured is proportional to antibody concentration in sample.

dioxetane-P dioxetane

= Paramagnetic particle coated with analyte

= Antibodies in sample

= Conjugate (antibody coupled with alkaline phosphatase)

dioxetanedioxetane-P= Reaction between substrate and conjugate produces light

Legend

= Wash 3 times

System Assays


Para-magnetic Particles

Micron size paramagnetic particles are used as the solid phase to separate the bound from the unbound analyte. During wash cycles, magnets are used to pull 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-nescence

Luminescence is defined as the emission of light associated with the dissipation of 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 Reagent Packs

The Access reagent pack contains enough reagents to perform up to 50 tests. Refer to the product inserts or the reagent pack label to determine the number of tests included in each pack. The reagent packs are covered with an elastomeric l

access immunoassay system manual

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