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Operator's Guide

P/N B14251EFebruary 2015

Printed in U.S.A.© 2015 Beckman Coulter, Inc.

BECKMAN COULTER, INC. • 250 S. KRAEMER BLVD. • BREA, CA 92821 • U.S.A.

Publication Notes

This manual, P/N B14251E, release date 2/15, supports Access 2 system software version 3.4.2 and Access 2i operating software version 6.2.2.

Each page of the Access 2 Operator’s Guide 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 two revision releases. The pages listed below are issued as P/N B14251E, release date 2/15:

• Title Page and Publication Notes

• Chapter 3: pages 3-19 and 3-38

All other pages are issued as P/N B14251D, release date 9/14.

Changes to this Revision

Revision E of this manual includes the following changes:

• Added statement about assays with temperature restrictions to sections 3.2 and 3.3

This guide is intended for use with the Access 2 Immunoassay System. This guide also can be used as supplemental material for the UniCel DxC 600i system, which consists of an Access 2 system integrated with a UniCel DxC 600 system.

© 2015 Beckman Coulter, Inc.

Beckman Coulter, Inc. grants a limited non-exclusive license to the Access 2 system owner or operator to make a copy of all or a portion of this book solely for laboratory use.

Beckman Coulter, the stylized logo, Access, and UniCel are trademarks of Beckman Coulter, Inc. and are registered in the USPTO.

Access 2 Operator’s Guide Table of Contents

2014 Beckman Coulter,P/N B14251D 9/14

Table of Contents

Table of Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i

List of Figures and Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi

Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface-1

1 System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

1.1 System Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3

1.2 Instrument Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4

1.3 Software Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13

2 Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1

2.1 Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3

2.2 Wash Buffer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10

2.3 Liquid Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13

2.4 Substrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17

2.5 Reaction Vessels (RVs) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24

2.6 Reaction Vessel Waste Bag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-28

2.7 Reagent Packs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-31

2.8 Reagent Inventory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-40

3 Sample Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

3.1 Sample Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

3.2 Patient Test Requests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19

Inc. iii

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3.3 Calibration Test Requests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-38

3.4 Quality Control Test Requests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-43

3.5 Working with On-Board Samples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-48

4 Sample Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1

4.1 Sample Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

4.2 Supply and Calibration Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-11

4.3 Work Pending . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-19

4.4 Monitoring Sample Progress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25

5 Test Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1

5.1 Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2

5.2 Reviewing Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9

5.3 Managing Test Results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31

5.4 Test Result Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-42

6 Assay Calibrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1

6.1 Assay Calibrations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2

6.2 Reviewing Calibration Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8

6.3 Calibration Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17

6.4 Setting Up Calibrators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-22

7 Quality Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1

7.1 Quality Controls. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3

7.2 Reviewing Quality Control Charts and Data . . . . . . . . . . . . . . . . . . . . . . 7-9

7.3 Quality Control Reports. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-26

7.4 Setting Up Quality Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-31

7.5 Establishing QC Ranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-39

7.6 Quality Control Worksheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-42

8 Routine Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1

8.1 Routine Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3

8.2 Daily Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-14

2014 Beckman Coulter, Inc.P/N B14251D 9/14

Access 2 Operator’s Guide Table of Contents


8.3 Weekly Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-27

8.4 System Check. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-45

8.5 Special Clean . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-57

8.6 Maintenance Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-62

A Racks and Sample Containers . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-1

A.1 Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-2

A.2 Sample Containers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-5

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Index-1

Inc. v

List of Figures and Tables Access 2 Operator’s Guide

vi

List of Figures and Tables

Table 1 Operator’s Guide Chapters. . . . . . . . . . . . . . . . . . . . . . . . . Preface-2

Table 2 Reference Manual Chapters . . . . . . . . . . . . . . . . . . . . . . . . Preface-3

Table 3 Help System Books (or Pages) . . . . . . . . . . . . . . . . . . . . . . Preface-5

Table 4 Help System Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface-9

Table 5 Help Button Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . Preface-10

Figure 6 Help Window Button Bar . . . . . . . . . . . . . . . . . . . . . . . . . Preface-12

Table 7 Help Window Button Bar Descriptions . . . . . . . . . . . . . . Preface-12

Figure 8 Help Topics Window (Contents View) . . . . . . . . . . . . . . Preface-13

Table 9 Help Topics Window Descriptions. . . . . . . . . . . . . . . . . . Preface-14

Figure 10 Help Topics Window (Find View) . . . . . . . . . . . . . . . . . . Preface-15

Table 11 Notes, Cautions, and Warnings. . . . . . . . . . . . . . . . . . . . . Preface-16

Figure 1-1 Attention Safety Symbol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

Figure 1-2 Electrical Safety Symbol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6

Figure 1-3 Biohazard Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

Figure 1-4 Sharp Objects Symbol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

Figure 1-5 Moving Parts Symbol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7

Figure 1-6 Electrostatic Discharge Symbol . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8

Figure 1-7 Laser Symbol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8

Figure 1-8 Canadian Standards Association Symbol . . . . . . . . . . . . . . . . . . . 1-9

Figure 1-9 CE Mark . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

Figure 1-10 C-Tick Mark . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9

Figure 1-11 WEEE Mark . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10

Figure 1-12 EU Battery Directive Symbol . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10

Figure 1-13 RoHS Caution Logo . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11

Figure 1-14 RoHS Environmental Logo . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11


Access 2 Operator’s Guide List of Figures and Tables


Figure 1-15 Main Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15

Table 1-16 Main Menu Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15

Figure 1-17 Main Menu Work Flow. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18

Figure 1-18 Common Access 2 System Screen Elements . . . . . . . . . . . . . . . 1-19

Table 1-19 System Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19

Table 1-20 System Command Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20

Table 1-21 System Status Buttons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-21

Figure 1-22 Back and Menu Tabs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24

Table 1-23 Function Button Examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-25

Table 1-24 Information Field Examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26

Table 1-25 Keyboard Equivalents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27

Figure 1-26 OK/Cancel/Help Window Example . . . . . . . . . . . . . . . . . . . . . . 1-28

Figure 1-27 Report Headers and Standard Text . . . . . . . . . . . . . . . . . . . . . . . 1-30

Figure 2-1 Supplies Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6

Table 2-2 Supplies Screen Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7

Figure 2-3 Changing the Wash Buffer Bottle Flowchart . . . . . . . . . . . . . . . 2-11

Figure 2-4 Changing the Wash Buffer Bottle . . . . . . . . . . . . . . . . . . . . . . . . 2-12

Figure 2-5 Changing the Liquid Waste Bottle Flowchart. . . . . . . . . . . . . . . 2-14

Figure 2-6 Liquid Waste Bottle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16

Figure 2-7 Changing the Substrate Bottle Flowchart . . . . . . . . . . . . . . . . . . 2-18

Figure 2-8 Change Substrate Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19

Table 2-9 Change Substrate Window Descriptions. . . . . . . . . . . . . . . . . . . 2-19

Figure 2-10 Substrate Bottles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21

Figure 2-11 Substrate Supply Cap Configurations . . . . . . . . . . . . . . . . . . . . . 2-22

Figure 2-12 Finger Tighten Substrate Supply Cap Fittings . . . . . . . . . . . . . . 2-22

Figure 2-13 Loading RVs Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25

Figure 2-14 Inserting an RV Cartridge into the RV Supply Area . . . . . . . . . 2-26

Figure 2-15 Changing the RV Waste Bag Flowchart . . . . . . . . . . . . . . . . . . . 2-29

Figure 2-16 Loading a Reagent Pack Flowchart. . . . . . . . . . . . . . . . . . . . . . . 2-32

Figure 2-17 Load Reagent Pack Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-34

Table 2-18 Load Reagent Pack Window Descriptions . . . . . . . . . . . . . . . . . 2-34

Figure 2-19 Loading a Reagent Pack into the Reagent Carousel . . . . . . . . . . 2-35

Figure 2-20 Scanning a Reagent Pack Bar Code with the Bar Code Wand . . 2-36

Figure 2-21 Unloading a Reagent Pack Flowchart . . . . . . . . . . . . . . . . . . . . . 2-37

Figure 2-22 Reagent Inventory Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-42

Inc. vii


viii

Table 2-23 Reagent Inventory Screen Descriptions . . . . . . . . . . . . . . . . . . . 2-43

Figure 2-24 Filter (Reagent Inventory) Window . . . . . . . . . . . . . . . . . . . . . . 2-46

Table 2-25 Filter (Reagent Inventory) Window Descriptions . . . . . . . . . . . 2-46

Figure 2-26 Deleting a Reagent Pack Flowchart . . . . . . . . . . . . . . . . . . . . . . 2-48

Figure 2-27 Reagent Inventory Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-50

Figure 3-1 Sample Management Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4

Figure 3-2 Sample Manager Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5

Table 3-3 Sample Manager Screen Descriptions . . . . . . . . . . . . . . . . . . . . . 3-6

Figure 3-4 Loading Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12

Table 3-5 Rack Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13

Figure 3-6 Test Requests Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20

Table 3-7 Test Requests Screen Descriptions . . . . . . . . . . . . . . . . . . . . . . . 3-20

Figure 3-8 Processing LIS Test Requests Flowchart . . . . . . . . . . . . . . . . . . 3-27

Figure 3-9 Entering Patient Test Requests Manually Flowchart . . . . . . . . . 3-30

Figure 3-10 Test Menu (Patient Samples) . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-32

Table 3-11 Test Menu (Patient Samples) Descriptions. . . . . . . . . . . . . . . . . 3-32

Figure 3-12 Using Auto Sample ID Flowchart . . . . . . . . . . . . . . . . . . . . . . . 3-34

Figure 3-13 Using Batch Request Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . 3-36

Figure 3-14 Entering Calibration Test Requests Flowchart . . . . . . . . . . . . . . 3-39

Figure 3-15 Request Calibration Window . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-40

Figure 3-16 Test Menu (Calibration) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-41

Table 3-17 Test Menu (Calibration) Descriptions . . . . . . . . . . . . . . . . . . . . 3-41

Figure 3-18 Entering Quality Control Test Requests Flowchart . . . . . . . . . . 3-44

Figure 3-19 Request QC Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-45

Figure 3-20 Test Menu (QC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-46

Table 3-21 Test Menu (QC) Descriptions. . . . . . . . . . . . . . . . . . . . . . . . . . . 3-46

Figure 3-22 Adding, Removing, and Rearranging On-Board Samples Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-49

Figure 3-23 Editing Test Requests for On-Board Samples Flowchart . . . . . . 3-51

Figure 3-24 Deleting Test Requests for On-Board Samples Flowchart . . . . . 3-53

Figure 3-25 Adding Test Requests to On-Board Samples Using the Pause Button Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-55

Figure 3-26 Deleting Test Requests from On-Board Samples Using the Pause Button Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-57




Figure 4-1 Processing Samples Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4

Table 4-2 Sample Processing Order Criteria . . . . . . . . . . . . . . . . . . . . . . . . . 4-7

Table 4-3 Rules for One Sample Container or Instrument . . . . . . . . . . . . . . 4-8

Table 4-4 Rules for Multiple Sample Containers or Instruments . . . . . . . . . 4-9

Figure 4-5 Supplies Required Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-13

Table 4-6 Supplies Required Screen Descriptions . . . . . . . . . . . . . . . . . . . 4-13

Figure 4-7 Supplies Required Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18

Figure 4-8 Work Pending Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-20

Table 4-9 Work Pending Screen Descriptions. . . . . . . . . . . . . . . . . . . . . . . 4-20

Figure 4-10 Filter (Work Pending) Window. . . . . . . . . . . . . . . . . . . . . . . . . . 4-22

Table 4-11 Filter (Work Pending) Window Descriptions . . . . . . . . . . . . . . . 4-22

Figure 4-12 Work Pending Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-24

Table 4-13 Rack Status Descriptions for Sample Manager Screen . . . . . . . . 4-26

Table 4-14 Sample Status Descriptions for Test Requests Screen . . . . . . . . 4-27

Table 4-15 Test Status Descriptions for the Test Results Screen . . . . . . . . . 4-27

Figure 5-1 Test Results Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3

Figure 5-2 Test Results Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4

Table 5-3 Test Results Screen Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . 5-5

Figure 5-4 Applying a Test Result Filter Flowchart . . . . . . . . . . . . . . . . . . . 5-11

Table 5-5 Filters and Default Sort Orders . . . . . . . . . . . . . . . . . . . . . . . . . . 5-11

Figure 5-6 Filter (Test Results) Window . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12

Table 5-7 Filter (Test Results) Window Descriptions. . . . . . . . . . . . . . . . . 5-12

Figure 5-8 Editing a Test Result Filter Flowchart . . . . . . . . . . . . . . . . . . . . 5-14

Figure 5-9 Edit Filter (Test Results) Window . . . . . . . . . . . . . . . . . . . . . . . 5-15

Table 5-10 Edit Filter (Test Results) Window Descriptions . . . . . . . . . . . . . 5-16

Figure 5-11 Defining a New Test Result Filter Flowchart . . . . . . . . . . . . . . . 5-18

Figure 5-12 Specify a Date Range (Test Results Filter) Window . . . . . . . . . 5-20

Table 5-13 Specify a Date Range (Test Results Filter) Window Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-21

Figure 5-14 Finding a Test Result Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . 5-22

Figure 5-15 Find (Test Result) Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-23

Table 5-16 Find (Test Result) Window Descriptions . . . . . . . . . . . . . . . . . . 5-23

Figure 5-17 Viewing Sample Details Flowchart. . . . . . . . . . . . . . . . . . . . . . . 5-25

Figure 5-18 Sample Details Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-26

Table 5-19 Sample Details Window Descriptions. . . . . . . . . . . . . . . . . . . . . 5-26

Inc. ix


x

Figure 5-20 Configuring the Test Results Screen Flowchart . . . . . . . . . . . . . 5-28

Figure 5-21 Configure Screen (Test Results) Window . . . . . . . . . . . . . . . . . 5-29

Table 5-22 Configure Screen (Test Results) Window Descriptions . . . . . . . 5-29

Figure 5-23 Sending Test Results to the LIS Flowchart . . . . . . . . . . . . . . . . 5-32

Figure 5-24 Send to LIS Window. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-33

Table 5-25 Send to LIS Window Descriptions . . . . . . . . . . . . . . . . . . . . . . . 5-33

Figure 5-26 Copying Test Results to a Disk or USB Flash Drive Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35

Figure 5-27 Copy to Disk (Test Results) Window . . . . . . . . . . . . . . . . . . . . . 5-37

Table 5-28 Copy to Disk (Test Results) Window Descriptions . . . . . . . . . . 5-37

Figure 5-29 Deleting a Test Result Flowchart . . . . . . . . . . . . . . . . . . . . . . . . 5-40

Table 5-30 Types of Test Result Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-42

Figure 5-31 Printing Test Result Reports Flowchart . . . . . . . . . . . . . . . . . . . 5-44

Figure 5-32 Print (Test Result Reports) Window. . . . . . . . . . . . . . . . . . . . . . 5-46

Table 5-33 Print (Test Result Reports) Descriptions . . . . . . . . . . . . . . . . . . 5-46

Figure 5-34 Patient Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-47

Figure 5-35 Sample Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-48

Figure 5-36 Selected Test Results Report . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-49

Figure 5-37 Continuous Sample Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-50

Figure 6-1 Calibration Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3

Figure 6-2 Calibration Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4

Table 6-3 Calibration Screen Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4

Figure 6-4 Filter (Calibration) Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6

Table 6-5 Filter (Calibration) Window Descriptions . . . . . . . . . . . . . . . . . . 6-6

Table 6-6 Stored Calibration Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9

Figure 6-7 Calibration Data Screen (Cutoff) . . . . . . . . . . . . . . . . . . . . . . . . 6-10

Figure 6-8 Calibration Data Screen (Curve). . . . . . . . . . . . . . . . . . . . . . . . . 6-11

Table 6-9 Calibration Data Screen (Cutoff and Curve) Descriptions . . . . . 6-11

Table 6-10 Calibration Failure Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14

Table 6-11 Calibration Report Formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17

Figure 6-12 Calibration Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-19

Figure 6-13 Calibration Data Report (Cutoff) . . . . . . . . . . . . . . . . . . . . . . . . 6-20

Figure 6-14 Calibration Data Report (Curve). . . . . . . . . . . . . . . . . . . . . . . . . 6-21

Figure 6-15 Calibrator Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-23

Table 6-16 Calibrator Setup Screen Descriptions . . . . . . . . . . . . . . . . . . . . . 6-24




Figure 6-17 Adding a Calibrator Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . 6-25

Figure 6-18 Add Calibrator Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-26

Table 6-19 Add Calibrator Window Descriptions. . . . . . . . . . . . . . . . . . . . . 6-26

Figure 7-1 Quality Controls Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4

Figure 7-2 Quality Control Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5

Table 7-3 Quality Control Screen Descriptions. . . . . . . . . . . . . . . . . . . . . . . 7-5

Figure 7-4 Filter (Quality Controls) Window . . . . . . . . . . . . . . . . . . . . . . . . . 7-7

Table 7-5 Filter (Quality Controls) Window Descriptions . . . . . . . . . . . . . . 7-7

Figure 7-6 QC Chart and Data Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-11

Table 7-7 QC Chart and Data Screen Descriptions . . . . . . . . . . . . . . . . . . . 7-11

Figure 7-8 Filter (QC Chart and Data) Window . . . . . . . . . . . . . . . . . . . . . . 7-16

Table 7-9 Filter (QC Chart and Data) Window Descriptions . . . . . . . . . . . 7-16

Figure 7-10 Compare Charts Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-21

Table 7-11 Compare Charts Screen Descriptions . . . . . . . . . . . . . . . . . . . . . 7-21

Figure 7-12 Comparing QC Charts Flowchart . . . . . . . . . . . . . . . . . . . . . . . . 7-24

Figure 7-13 QC Review Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-27

Figure 7-14 Print (QC Chart and Data) Window . . . . . . . . . . . . . . . . . . . . . . 7-28

Table 7-15 Print (QC Chart and Data) Window Descriptions. . . . . . . . . . . . 7-28

Figure 7-16 QC Data Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-29

Figure 7-17 QC Chart Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-30

Figure 7-18 Setting Up Quality Controls Flowchart. . . . . . . . . . . . . . . . . . . . 7-32

Figure 7-19 QC Setup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-33

Table 7-20 QC Setup Screen Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . 7-34

Figure 7-21 Add Control Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-35

Table 7-22 Add Control Window Descriptions. . . . . . . . . . . . . . . . . . . . . . . 7-35

Figure 7-23 Quality Control Worksheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-43

Figure 8-1 Maintenance Review Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5

Table 8-2 Maintenance Review Screen Descriptions . . . . . . . . . . . . . . . . . . 8-6

Figure 8-3 Request Maintenance Window . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-9

Table 8-4 Request Maintenance Window Descriptions . . . . . . . . . . . . . . . . 8-9

Figure 8-5 Maintenance Requests Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . 8-12

Table 8-6 Maintenance Requests Screen Descriptions . . . . . . . . . . . . . . . . 8-12

Figure 8-7 Daily Maintenance Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-15

Figure 8-8 Daily Maintenance: Checking the System Status Flowchart . . . 8-17

Figure 8-9 Daily Maintenance: Inspecting the Fluidic Module Flowchart. . 8-19

Inc. xi


xii

Figure 8-10 Daily Maintenance: Cleaning the Wash Carousel Probe Exteriors Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-20

Figure 8-11 Dispense, Aspirate, and Substrate Probes . . . . . . . . . . . . . . . . . . 8-21

Figure 8-12 Daily Maintenance: Priming the Substrate Flowchart . . . . . . . . 8-22

Figure 8-13 Daily Maintenance: Running the Daily Clean System Routine Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-24

Figure 8-14 Weekly Maintenance Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . 8-28

Figure 8-15 Weekly Maintenance: Checking for Fluid in the Waste Filter Bottle Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-31

Figure 8-16 Weekly Maintenance: Inspecting and Cleaning thePrimary Probe Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-32

Figure 8-17 Primary Probe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-33

Figure 8-18 Weekly Maintenance: Replacing the Aspirate Probes Flowchart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-34

Figure 8-19 Aspirate Probes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-35

Figure 8-20 Disconnecting Aspirate Probe Tubing at the Barbed Fitting . . . 8-36

Figure 8-21 Aspirate Probe Tubing and Barbed Fitting . . . . . . . . . . . . . . . . . 8-37

Figure 8-22 Weekly Maintenance: Precleaning the Aspirate Probes Flowchart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-39

Figure 8-23 Weekly Maintenance: Cleaning the Aspirate Probes with Contrad 70 Cleaning Solution Flowchart . . . . . . . . . . . . . . . . . . 8-41

Figure 8-24 Attaching Syringe Fitting Assembly . . . . . . . . . . . . . . . . . . . . . . 8-42

Figure 8-25 Weekly Maintenance: Cleaning the Aspirate Probes with Distilled Water Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . 8-43

Figure 8-26 System Checks Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-46

Table 8-27 System Checks Screen Descriptions . . . . . . . . . . . . . . . . . . . . . . 8-47

Figure 8-28 System Check Data Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-48

Table 8-29 System Check Data Screen Descriptions . . . . . . . . . . . . . . . . . . 8-48

Figure 8-30 System Check Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-51

Figure 8-31 Running the System Check Routine Flowchart . . . . . . . . . . . . . 8-52

Table 8-32 System Check Routine Expected Results . . . . . . . . . . . . . . . . . . 8-56

Figure 8-33 Special Clean Routine Flowchart . . . . . . . . . . . . . . . . . . . . . . . . 8-58

Table A-1 Sample Containers with Corresponding Rack and Rack IDs . . . .A-3

Figure A-2 Rack Bar Code Label Placement. . . . . . . . . . . . . . . . . . . . . . . . . .A-4

Figure A-3 Sample Bar Code Label Placement. . . . . . . . . . . . . . . . . . . . . . . .A-7

Figure A-4 Loading Insert Cups . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-8

Table A-5 Sample Containers with Rack and Volume Requirements . . . . . .A-9


Access 2 Operator’s Guide Preface

Preface

About This Manual .................................................................................Preface-2

Other Access 2 System Documentation..................................................Preface-3

Using the Manual ....................................................................................Preface-6

Using the Help System............................................................................Preface-8

Notes, Cautions, and Warnings.............................................................Preface-16

Technical Support .................................................................................Preface-16

2014 Beckman Coulter, Inc. Preface-1P/N B14251D 9/14

Preface Access 2 Operator’s Guide

About This Manual

This Operator’s Guide provides the step-by-step information needed for everyday operation of the Access 2 system. The Operator’s Guide contains the following chapters:

Preface • Overviews of the Access 2 system documentation

• Information about using the manual, using the Help system, and contacting Technical Support

Chapter 1System Overview

• General overviews of the Access 2 system, the instrument, the software, and the safety features

Chapter 2Supplies

• How to view on-board supply status, replenish supplies, and empty or replace waste containers

• How to view open reagent pack inventory

Chapter 3Sample Management

• How to load, unload, and clear racks

• How to view the onboard and inventory rack lists

• How to request patient, calibration, and quality control tests

• How to add, remove, or rearrange on-board samples

Chapter 4Sample Processing

• How to start, pause, stop, and monitor sample processing

• How to verify supply and calibration conditions before running tests

• How to process work pending

Chapter 5Test Results

• How to view, interpret, and work with test results

Chapter 6Assay Calibrations

• How to review calibration data for the instrument and set up calibrators for all instruments in the workgroup

Chapter 7Quality Controls

• How to review quality control data and set up quality controls for all the instruments in the workgroup

Chapter 8Routine Maintenance

• How to perform daily and weekly maintenance

• How to run the System Check and Special Clean routines

• How to manage or run the Utility Assay

Table 1 Operator’s Guide Chapters

Preface-2 2014 Beckman Coulter, Inc.P/N B14251D 9/14


Other Access 2 SystemDocumen-tation

In addition to this Operator’s Guide, the following printed and online documentation is available for the Access 2 system.

Reference Manual

The Reference Manual provides background, theory, troubleshooting, and advanced maintenance information. The Reference Manual contains the following chapters:

Appendix ARacks and Sample Containers

• How to attach bar code labels to racks and sample containers

• Information about minimum volume, dead volume, and rack IDs for the various sample containers

Table 1 Operator’s Guide Chapters (continued)

Preface • A listing of the Access 2 system documentation

• Information about contacting Technical Support

Chapter 1Technology Overview

• Technical overviews of the Access 2 system and its hardware modules

• Overview of the immunoassay technology used by the system to detect and measure analytes

Chapter 2System Specifications

• Access 2 system spatial requirements, operating environment requirements, and electrical requirements

• Component performance characteristics, system and supply capacities, bar code sample requirements, and other specifications

Chapter 3Theory of Operation

• Theory of sample processing, including typical movement of an RV through the system and obstruction detection

• Theory of luminometer and assay calibrations, quality controls, and how the System Check routine can be used to verify system performance

Table 2 Reference Manual Chapters



Chapter 4System Configuration

• How to configure general system parameters for your laboratory, including report, printer, back up scheduling, and LIS (laboratory information system) information

• How to set up the bar code reader for the symbologies you use

• How to configure tests, result information, test panels, and reflex tests

Chapter 5Diagnostics

• How to initialize the system, prime the fluidics, and perform dispense and aspirate volume checks

• How to view and perform diagnostic checks on mechanical, analog, and digital devices, and the LIS

Chapter 6Event Log

• How to review and troubleshoot caution and warning events

• Numeric list of cautions and warnings by system module

Chapter 7System Support Procedures

• How to service the instrument as needed for troubleshooting or as directed by Technical Support

Appendix ATroubleshooting

• How to troubleshoot general instrument operation problems and out-of-range System Check routine results

• How to troubleshoot out-of-range assay calibration, quality control, and patient sample results

Appendix BSystem and Mode Availability Tables

• Details about which procedures you can perform on the workgroup instruments and which procedures you can perform on the server instrument only

• Details about which mode the workgroup instruments must be in to perform the procedures

Table 2 Reference Manual Chapters (continued)



Instrument Instructions for Use

The Access 2 instrument Instructions for Use is a printed manual, intended to be used after you have become familiar with the Access 2 system.

The instrument Instructions for Use contains short instructions for everyday use and routine maintenance. It also contains general information about the Access 2 system, such as theory of operation, system specifications, safety labeling, and troubleshooting. Ordering information for reagents and system supplies is provided in an Appendix.

Help System

The Access 2 Help system provides all of the information contained in the Operator’s

Guide and Reference Manual in a convenient online format that you can access from within the Access 2 system software.

The following books (or pages) are contained in the Help Topics window, which can be viewed by using the Contents tab:

About the Access 2 Immunoassay System

General information about how to use the system, what you can do from the Main Menu, and information about the warranty.

About Help Information about the Access 2 Help system and how to use it.

Publication Notes Information about changes to the Access 2 Immunoassay System documentation.

Access 2 Manuals Information about additional documentation for the Access 2 Immunoassay System, which is available in printed form or in online form on CD.

Glossary An alphabetical list of terms and definitions specific to the Access 2 system.

Operator's Procedures

The same procedural information provided in this Operator’s Guide. Chapter information is divided into separate books.

Reference Information System background, theory, troubleshooting, and advanced maintenance information.

Flowcharts All procedure overviews and procedure flowcharts, sorted alphabetically by subject.

Table 3 Help System Books (or Pages)



Online Manuals

Online versions of some documents are provided on CDs, to be used on a PC that is not connected to the Access 2 instrument.

• The LIS Vendor Information CD provides information needed to develop the interface that enables your laboratory information system to communicate with the Access 2 system. If your laboratory uses an LIS, provide this information to your LIS vendor. This document is available in English.

• The Material Safety Data Sheet (MSDS) CD contains safety precautions and warnings about the handling and storage of materials that are constituents of Access Immunoassay System assays and system supplies.

Using the Manual

To make information easier for you to find and use, Access 2 system documentation uses the following standards and styles.

Chapter Organization

Most of the chapters in the Operator’s Guide and Reference Manual contain flowcharts, screen and window captures, tables of screen or window item descriptions, and procedural or informational sections.

Flowcharts provide a quick reference or overview of the procedure or concept. Once you are familiar with the instrument and the step-by-step procedures, you may choose to use only flowcharts to guide you as you work with the instrument.

Screens and complex windows are illustrated in the manuals if you need explanations of their contents to understand how to perform a procedure. Simple windows that are self-explanatory are not included.

Forms/Logs/Worksheets

Illustrations of all suggested forms and worksheets you can use to record Access 2 activity.

Reports Illustrations of all system reports in alphabetical order.

Screens/Menus/ Windows

Illustrations and field descriptions of all screens and menus (alphabetized in one book) and complex windows (alphabetized in another book).

Table 3 Help System Books (or Pages) (continued)



System Status Buttons

The Access 2 system displays ten round status buttons on every screen. These buttons are graphical representations that are not labeled with text. Even though they have no text on them, the system documentation refers to these buttons by name. For example, the Wash Buffer status button is represented by this graphic:

For a list of system status button names and descriptions, see Chapter 1: System Overview.

Text Buttons, System Command Buttons, Field Names, and Options

In procedures, all text buttons, system command buttons (Stop, Pause, and Run), field names, and options are represented by the label of the item as it appears on the screen or window, in bold type. For example:

Select Filter F1. (text button)

Select Run. (system command button)

In the Sample ID field, enter the sample ID. (field name)

Select Auto Sample ID. (option in a field)

NOTES

• For consistency as illustrated in the previous examples, whether you touch the screen, point and click with the mouse, or press [Tab] to select a text button, system command button, or an option in a field, this documentation uses the term select.

• For information about how to navigate through the Help system, see the Reports topic in Chapter 1: System Overview.

Keys

When you perform an action exclusively with the keyboard, the key name or description is provided in bold type, in brackets. For example:

Press [Print Screen]. (key name)

Press the [Right Arrow] key. (key description)

1

1

1

1

1

1



Required Steps

Required steps in a procedure are indicated by sequentially numbered lists in the Help, and by numbered boxes in the manuals. For example:

This is the first required step in a procedure.

This is the second required step in a procedure.

Optional Steps

Optional steps in a procedure are indicated by an asterisk and the word (Optional) in the Help. Small, unnumbered boxes and the word (Optional) are used in the manuals. For example:

(Optional) This is an optional step in a procedure (manual).

Optional steps provide information about how to perform a task that you only need to do under some circumstances. For example, required steps in the Printing the Reagent Inventory Report procedure tell you how to print the report including all reagent packs. The optional step tells you how to print the report for selected packs only.

Using the Help System

When you select the Help from any Access 2 system software screen, a Help window is displayed. From the Help window, you can use the Help window button bar to perform operations (print or copy) on the currently displayed topic or to navigate to a different topic.

You can access the Help system from any system software screen and from some system software windows by pressing a Help button or [F12] Help on the keyboard.

1

2



Help Access

Description

Help from a Screen

On screens, the Help button is the round system status button with a question mark (?).

A screen also has function buttons, a Menu tab, system command buttons, and system status buttons. For more information about screens, see Chapter 1: System Overview.

When you select Help from a screen, the Help system displays information about the screen you are on and provides a button you can select to view the screen and its description.

Help from a

Window

In windows, the Help button is the rectangular Help F12 function button in the lower right corner.

A window may provide information about the status of the system or ask you a question that requires your response. For more information about windows, see Chapter 1: System Overview.

When you select Help from a window, the Help system displays procedural information related to the window you are in. Sometimes you can view the window and its description from the Help system, and sometimes you can view a flowchart of the procedure.

Help from Help

From any displayed Help topic, you can go to other topics using Help navigational features such as Help link buttons, the Help window button bar, the Help Topics window (tabs), the [F12] Help key on the keyboard, and the highlighted text (green).

Table 4 Help System Access



Help Link Buttons

The Help system uses several different buttons to indicate links to related information. These are examples of the buttons you will find in the Help system:

Button Description

(Arrow button) Select to display a related topic.

(See Also button) Select to display a window containing a list of related topics, which can offer more information about the subject.

NOTE

For the Japanese and Simplified Chinese languages, the See Also button is not available.

(Flowchart button) Select to display a flowchart of the procedure or overview.

You can find this button at the top of a procedure window.

(View Screen or View Window button) Select to display a graphic of the associated screen or window.

After the screen or window is displayed, you can move the cursor over the graphic to find out what areas of the graphic are selectable. The cursor changes from an arrow to a pointing finger if the area is selectable. From those selectable areas, a smaller window (popup) about that area of the screen or window is displayed.

(Navigation button) Select to display the associated screen or window navigation topic. Navigation topics may include directions on how to access the screen or window, lists of required and optional fields, and keyboard equivalents.

(Show Me button) Select to display an illustration of the procedure or step.

You can find this button anywhere in the Help system text, where a graphic would be helpful.

(Example button) Select to display a relevant example.

Table 5 Help Button Descriptions



Help Windows

The Help for the Access 2 system uses standard window types to display different types of information:

• Procedure (narrow window displaying on the right of the screen, usually lists steps to perform)

• Main (widest window displaying in the center of the screen, usually includes a column of arrow buttons on the left to link to more information)

• Picture (wide window displaying on the left of the screen, usually shows a screen, window, flowchart, or a picture of a portion of the instrument)

• Glossary (narrow window displaying on the right of the screen, usually lists items to link to, such as term definitions or event information)

• Popup (window displaying anywhere on the screen, usually provides a brief definition or description of an item and has no button bar or scroll bar)

When you display a Help window, it continues to be displayed until you display another window of the same type, select any part of the UI software visible beyond the edges of a Help window, or exit the Help system.

Exiting the Help System

If you select any part of the UI software while the Help system is displayed, the Help system becomes hidden from view. When you select a Help button again, in addition to the requested Help window, you may see Help windows that were displayed previously.

Exit the Help system by selecting Exit from the Help window button bar.

NOTE

Select Exit only when you are finished using the Help system. When you select Exit, all Help windows close.

(More Info button) Select to display another topic containing more information about the selected topic.

(Glossary button) Select to display the definition of the glossary term. Used only in the Glossary.

Button Description

Table 5 Help Button Descriptions (continued)



Help Window Button Bar

The Help window button bar displayed at the top of most Help windows contains the Find, Help Topics, Back, Print, Glossary, and Exit buttons.

NOTE

For the Japanese and Simplified Chinese languages, the Find button is not available.

0862b.bmp

Figure 6 Help Window Button Bar

Find (Button) Displays the Help Find tab in the Help Topics window, which allows you to search for a topic by keywords.

For more information on the Find feature, see the Help Find Feature topic later in this preface.

Help Topics (Button) Displays the Help Topics window. From this window, you can search the entire Help system and go directly to any topic.

For more information, see the Help Topics Window topic.

Back (Button) Select to return to the last displayed topic in the same type of window (such as a procedure window or a picture window).

This button is unavailable if the topic displayed is the first topic for that type of window.

Print (Button) Select to print the displayed topic.

Glossary (Button) Select to display the Help system glossary.

This button is only available from main (large) Help windows.

Table 7 Help Window Button Bar Descriptions



Help Topics Window

The Help Topics window contains the Contents, Index, and Find tabs, which you can use to locate topics within the Help system. To display the Help Topics window, select Help Topics from the Help Window Button Bar of most Help windows.

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Figure 8 Help Topics Window (Contents View)

Exit (Button) Select to exit the Help system.

Help Window Menu

The Help window menu contains features that are duplicates of others found in the Help system and features that can change Help appearance and performance. The Help system has been optimized for your use. You should not access the features in the Help window menu.

Table 7 Help Window Button Bar Descriptions (continued)

Select a topic book to display the contents

Select a topic page to display



Help Find Feature

You can use the Help Find feature to locate a word, phrase, or topic title anywhere in the Help system. You access the Help Find feature by selecting Find on the Help window button bar or the Find tab in the Help Topics window. Find is a full-text search feature. If you enter a word that is contained in multiple topics, Find is capable of displaying a list of every topic that contains the word.

The first time you use the Find feature, the Find Setup Wizard window is displayed. Before you can use this feature, the Help system must create a database to search from available database options.

• When you select Minimize database size, the Find feature displays a list of the main topics containing the word you enter. Minimum is the default and the recommended choice.

• When you select Maximize search capabilities, the Find feature displays a list of every topic containing the word you enter. When you select this option, the Find feature may operate at a slower rate.

Contents (Tab) Select to display the table of contents for the Help system.

From the table of contents, you can:

• Select a topic page (the white icon with ? inside) to display Help about the topic.

• Select a topic book, which expands to list more available topic pages and books related to the topic book.

Index (Tab) Select to locate information by:

• Typing the first few letters of a keyword, and then by selecting one of the available topics.

• Using the scroll bar, and then by selecting one of the available topics.

NOTE

For the Japanese and Simplified Chinese languages, scrolling is the only method of locating information in the index.

Find (Tab) Select to search for a topic by keywords.

For more information on the Help Find feature, see the Help Find Feature topic in this preface.

Table 9 Help Topics Window Descriptions



• When you select Customize search capabilities, you select the characteristics of the Find feature in response to questions provided by the Find Setup Wizard.

After you select a database option, select Next and then select Finish. The Help system creates the database and displays the Find window.

NOTES

• The Help system creates the Find database only the first time you select the Find feature.

• For the Japanese and Simplified Chinese languages, the Find feature of the Help system cannot be used.

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Figure 10 Help Topics Window (Find View)

Highlighted Text (Green)

The Access 2 Help system contains many links to related topics or information. When you select a link, Help displays the related topic, either in a new window or in a popup box. Links are indicated by buttons and highlighted text (green). When the cursor



moves over the green text, it changes from an arrow into a pointing finger. This indicates you can select the text and move to a related topic.

Notes, Cautions, and Warnings

The Access 2 system documentation uses notes, cautions, and warnings to draw your attention to important information, instrument operation instructions, and safety information.

Technical Support

For technical assistance with the Access 2 Immunoassay System:

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

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

NOTE

Be prepared to provide your system ID.

Help Icon

Manual Graphic

Description

(Note icon) Notes highlight or provide additional information.

(Caution icon) Cautions emphasize the possibility of damage to the instrument.

(Warning icon) Warnings emphasize the possibility either of harm to the operator, or because erroneous test results might be reported, of harm to the patient.

Table 11 Notes, Cautions, and Warnings

NOTE

CAUTION

WARNING


Access 2 Operator’s Guide 1: System Overview

1System Overview

1.1 System Overview ...........................................................................................1-3

1.2 Instrument Overview .....................................................................................1-4

Installation.........................................................................................................1-5

Warranty............................................................................................................1-5

Safety Features ..................................................................................................1-5

Safety Symbols and Statements ........................................................................1-6

Regulatory Symbols and Statements.................................................................1-9

1.3 Software Overview ......................................................................................1-13

Running Other Applications ........................................................................... 1-14

Main Menu......................................................................................................1-14

Main Menu Workflow .................................................................................... 1-17

Common Screen Elements ..............................................................................1-19

System Modes ................................................................................................. 1-19

System Command Buttons..............................................................................1-20

System Status Buttons..................................................................................... 1-21

Scroll Bar ........................................................................................................ 1-24

Back and Menu Tabs....................................................................................... 1-24

Function Buttons ............................................................................................. 1-24

Information Fields........................................................................................... 1-25

2014 Beckman Coulter, Inc. 1-1P/N B14251D 9/14

1: System Overview Access 2 Operator’s Guide

Status Line....................................................................................................... 1-26

System Navigation .......................................................................................... 1-26

Common Windows ......................................................................................... 1-27

Reports ............................................................................................................ 1-29

1-2 2014 Beckman Coulter, Inc.P/N B14251D 9/14

Access 2 Operator’s Guide 1.1: System Overview

1.1System Overview

The Access 2 system is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

Access 2 immunoassays are heterogeneous, enzyme-mediated assays. Coated paramagnetic particles react with patient sample and assay-specific reagents to form immune complexes, and a magnetic field separates the bound immune complexes from the unbound. Chemiluminescent substrate reacts with an enzyme label present in the bound complexes and releases light. A luminometer measures the light emitted, and the system converts this reading into a sample result.

The system processes patient, quality control, and calibration samples in individual, disposable, plastic tubes called reaction vessels (RVs) with reagent from up to 24 on-board reagent packs.

The Access 2 system provides random, continuous, and STAT access. Random access allows you to perform any assay on any sample, using the on-board reagent packs. Continuous and STAT access allow you to schedule additional or STAT samples, replenish most supplies, and change waste containers while the instrument is processing samples. The system schedules assays as defined by the assay protocol file (APF) for each assay, and ensures adequate supplies to complete the assays. When a STAT assay is added, the instrument automatically reschedules other samples in a run to process the STAT sample first.

The Access 2 system can operate in workgroups of 1-4 instruments, depending upon your lab requirements.

For information about the Access 2 system, instrument, and assay technology, see Chapter 1: Technology Overview in the Reference Manual.


1.2: Instrument Overview Access 2 Operator’s Guide

1.2Instrument Overview

The Access 2 system uses the following six instrument hardware modules to accomplish sample processing:

• The carousel module includes the sample carousel, reagent carousel, cup/tube detector, and internal bar code reader. The sample carousel holds the racks. The reagent carousel holds the reagent packs. The cup/tube detector identifies if a sample container is present in each position on the rack. The internal bar code reader scans bar coded rack and sample container information.

• The main pipettor module includes the pipettor gantry, main pipettor, precision pump, and ultrasonic transducer. This module transfers samples, reagents, and wash buffer (for dilutions, if necessary) to the reaction vessels.

• The analytical module includes the reaction vessel loader, incubator belt, and wash/read carousel. This module transports reaction vessels through incubation, washing, addition of substrate, luminometer reading, and transmits the reading to the electronics module.

• The fluidic module includes the probe wash tower, vacuum pump, vacuum reservoir, substrate pump, wash pump, waste pump, and fluids tray. This module works together with the main pipettor module and the analytical module to dispense reagents and samples, wash the samples and the probes, dispense substrate, and store liquid waste.

• The electronics module includes a power supply, reset button, interlock switch, reaction vessel load door alarm, printed circuit boards, internal hard drive, and sometimes a 3.5-inch disk drive for troubleshooting the system.

• The peripherals module includes the external computer, keyboard, pointing device (mouse), monitor, printer, and handheld bar code reader. The external computer has its own hard drive, 3.5-inch disk or USB flash drive, CD-ROM or DVD drive, modem, and backup tape or USB flash drive. You use the peripheral components to direct and monitor the Access 2 system


Access 2 Operator’s Guide 1.2: Instrument Overview

through the system software, to make a backup of your system data, to copy data, and to print reports.

For more information about instrument technology, see Section 1.2: Instrument Technology in the Reference Manual.

Installation The Access 2 Immunoassay System must be installed by a qualified Beckman Coulter technical support representative. Do not remove the instrument from the shipping crate until a technical support representative is present.

Warranty The Access 2 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.

The customer is responsible for the routine preventive maintenance procedures described in this manual (see Chapter 8: Routine Maintenance). 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.

Safety Features

The Access 2 Immunoassay System is designed to meet U.S. and international safety standards. Safety labels are affixed to the instrument to alert you to safety considerations, and an interlock switch stops the movement of the main pipettor to protect you from injury if you were to open the instrument’s front panel while the system is running.

Interlock Switch

WARNINGDo not defeat the safety interlock switches on the covers.

The Access 2 system is equipped with an interlock switch to protect you from injury. If you open the front panel of the instrument, the interlock switch stops the movement of the main pipettor. Other mechanical devices will continue to operate with the front panel open. If you open the front panel while the system is processing samples, the system may cancel tests.



Safety Symbols and Statements

Certain areas of the Access 2 instrument present a risk of personal injury or damage to the instrument if proper safety procedures are not followed. These areas are marked with one or more safety symbols to identify the hazard. The following topics show the symbols and describe the hazards.

Attention Safety Symbol

A symbol with an exclamation point (see Figure 1-1) calls attention to important information to read, or is accompanied by another symbol indicating a particular safety hazard. The information is located either on the label with the symbol, or in the Access 2 customer documentation. In a document or in the Help system, the text following the symbol provides additional information regarding safety conditions. Also see the Safety Statements topic.

2207A.eps

Figure 1-1 Attention Safety Symbol

Electrical Safety Symbol

The general electrical safety symbol (see Figure 1-2) indicates an electrical shock hazard.

• The system uses high voltage to operate the ultrasonic probe.

• The luminometer contains a high voltage power supply that presents a shock hazard. The power supply box does not contain operator-serviceable parts.

• The electronics module contains high voltage circuitry that operates the ultrasonic probe. This circuitry presents a shock hazard if you open the electronics module. The electronics module does not contain operator-serviceable parts.

2206A.eps

Figure 1-2 Electrical Safety Symbol



Biohazard Symbols

The biohazard symbols (see Figure 1-3) indicate areas of the instrument and associated fluid handling equipment that can contain potentially infectious human serum or blood products. Follow good laboratory practices in handling and disposing of materials from these areas.

2183B.eps

Figure 1-3 Biohazard Symbols

Sharp Objects Symbol

The sharp objects symbol indicates areas of the instrument in which the skin can be punctured. Do not put your hands in areas marked with this symbol while the instrument is running.

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Figure 1-4 Sharp Objects Symbol

Moving Parts Symbol

The moving parts symbol indicates areas of the instrument in which moving parts can cause injuries. Do not operate the instrument with the covers open.

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Figure 1-5 Moving Parts Symbol



Electrostatic Discharge Symbol

The electrostatic discharge (ESD) symbol indicates areas of the instrument which can be damaged by static discharge.

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Figure 1-6 Electrostatic Discharge Symbol

Laser Symbol

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

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Figure 1-7 Laser Symbol

Safety Statements

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

WARNINGS• Reagents, calibrators, and controls used with the system may contain small

quantities of sodium azide preservative. Sodium azide preservative may form explosive compounds in metal drain lines. Refer to National Institute for Occupational Safety and Health Bulletin: Explosive Azide Hazards (8/18/76).

• The Access 2 instrument has moving parts and uses high voltage in the ultrasonic transducer. Both present an injury hazard. You should not operate the Access 2 instrument with the covers open.

CAUTION

Always plug the Access 2 system into a grounded three-conductor outlet. DO NOT bypass the grounding prong on the plug.



Regulatory Symbols and Statements

The Access 2 Immunoassay System meets the requirements of a variety of domestic and international regulatory agencies, standards, and directives. This compliance is indicated by symbols and marks on the instrument, and by related statements in the system documentation.

CSA Symbol

The Canadian Standards Association (CSA) symbol (see Figure 1-2) indicates that the Access 2 Immunoassay System meets all U.S. and Canadian requirements for electrical safety.

2186A.eps

Figure 1-8 Canadian Standards Association Symbol

CE Mark

A label with the CE mark of conformity (see Figure 1-9) is attached to the back panel of Access 2 Immunoassay System instruments. This label signifies that the Access 2 Immunoassay System complies with applicable EU directives. The instrument Declaration of Conformity lists the directives with which the Access 2 system complies.

2205A.eps

Figure 1-9 CE Mark

C-Tick Mark

A label with the C-Tick mark indicates that the instrument complies with applicable Australian Communications Authority requirements.

2195A.eps

Figure 1-10 C-Tick Mark

C US



WEEE Mark

It is important to understand and follow all laws regarding the safe and proper disposal of electrical instrumentation. The symbol of a crossed-out wheeled bin on the product is required in accordance with the Waste Electrical and Electronic Equipment (WEEE) Directive of the European Union. The presence of this marking on the product indicates that the device:

• was put on the European Market after August 13, 2005.

• is not to be disposed via the municipal waste collection system of any member state of the European Union.

For products under the requirement of WEEE directive, please contact your dealer or local Beckman Coulter office for the proper decontamination information and take-back program, which will facilitate the proper collection, treatment, recovery, recycling, and safe disposal of the device.

2328A.eps

Figure 1-11 WEEE Mark

EU Battery Directive

Battery Safety and Disposal Instructions - Dispose of all batteries in accordance with local regulations.

If you have any questions, please contact your local Beckman Coulter representative for information on the correct disposal or recycle programs for batteries.

Beckman Coulter products can have two types of batteries.

• User-Replaceable - Consult the product operating manual for battery replacement instructions.

• Non-User-Replaceable - Please contact your local Beckman Coulter representative.

2350A.eps

Figure 1-12 EU Battery Directive Symbol



RoHS Marks

The following labels and declarations meet the People’s Republic of China Electronic Industry Standard SJ/T11364-2006 marking requirement for control of pollution caused by electronic information products.

This logo (see Figure 1-13) indicates that this electronic information product contains certain toxic or hazardous substance or elements, and can be used safely during its environmental protection use period. The number in the middle of the logo indicates the environmental protection use period (in years) for the product. The outer circle indicates that the product can be recycled. The logo also signifies that the product should be recycled immediately after its environmental protection use period has expired. The date on the label indicates the date of manufacture.

2326A.bmp

Figure 1-13 RoHS Caution Logo

This logo (see Figure 1-14) indicates that the product does not contain any toxic or hazardous substances or elements. The "e" stands for electrical, electronic and environmental electronic information products. This logo indicates that this electronic information product does not contain any toxic or hazardous substances or elements, and is green and is environmental. The outer circle indicates that the product can be recycled. The logo also signifies that the product can be recycled after being discarded, and should not be casually discarded.

2327A.eps

Figure 1-14 RoHS Environmental Logo

Radio Frequency Emissions Statement

This IVD equipment complies with the emission and immunity requirements described in IEC 61326-2-6.

The Access 2 system has been tested and shown to be compliant with the requirements of CISPR 11 and part 15 of FCC rules for a Class A digital device.

XXXXXX-XX



These requirements are intended to provide reasonable protection from interference when the instrument is operated in a commercial environment.

CAUTIONS

• This equipment has been designed and tested to CISPR 11 Class A. In a domestic environment it could cause radio interference, in which case you may need to take measures to mitigate the interference.

• Prior to operation of this device, the electromagnetic environment should be evaluated. Do not use this device in close proximity to sources of strong electromagnetic radiation (for example, unshielded intentional RF sources) as these could interfere with proper operation.

• If you suspect interference between the Access 2 system and other equipment, you must take whatever action is required to correct the interference. Beckman Coulter suggests the following actions:

1. Move the equipment so there is a greater distance between the equipment and the Access 2 system.

2. Re-orient the equipment with respect to the Access 2 system.

3. Be sure the equipment is operating from a different power service connector than that of the Access 2 system.

LED Safety Statement

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


Access 2 Operator’s Guide 1.3: Software Overview

1.3Software Overview

The Access 2 system software consists of a real-time operating system in the instrument and a PC-based user interface (UI) software. The instrument software controls all of the processing functions. The UI software allows you to interface with and direct the instrument software. It also contains database, sample, calibration, quality control, and LIS information, as well as the assay protocol files (APFs). The APFs contain assay-specific information about sample processing and calculating test results. The UI software is located on the hard drive of the external computer (PC). The instrument software, UI software, and APFs are installed on the system through the PC’s CD-ROM drive.

The system software functions are organized into a set of screens that have common elements. From any screen, you can run, pause, or stop the instrument, monitor its system mode, access the Help system, view the Event Log, select options to operate the system, and go to other screens.

NOTES

• Your ability to perform these functions can depend upon the instrument’s system mode. For example, it is not possible to select Run when the instrument is in the Not Ready mode.

• You cannot select Run from a limited number of screens, such as the Diagnostics screen.

The system will sometimes display a smaller window on top of a screen to prompt you to perform an action, confirm that you want the system to perform an action, display a message, or allow you to enter information. When entering information in a window, you can use basic keyboard commands, such as Ctrl+C (copy) or Ctrl+V (paste), to transfer information between windows. For example, you can copy a comment from the Sample Comments window and paste it in the same window for another sample, or copy and paste a formula when setting up derived results.


1.3: Software Overview Access 2 Operator’s Guide

The software also comes with a Laboratory Information System (LIS) feature, which allows an external LIS to communicate with a workgroup through one LIS serial line. Test requests entered at the LIS are transmitted to the workgroup for processing. Once processing is complete, the test results are sent back to the LIS system. The workgroup data is managed from a single computer acting as the workgroup server.

For more information about system modes, see Table 1-19 in this section. For more information about the system mode required to perform a specific procedure, see Appendix B: System and Mode Availability Tables in the Reference Manual.

For more information about instrument technology or the LIS system, see Chapter 1: Technology Overview in the Reference Manual.

For more information about setting up an LIS system, see section 4.9 LIS Setup in the Reference Manual.

Running Other Applications

Only the Access 2 software should be installed on your PC. If a software application other than the authorized Access 2 Immunoassay System software is detected on your PC, it must be removed.

Main Menu The Main Menu is the first screen you see when the system is installed or initialized. To get to this menu from any screen, press [F9].

You can navigate everywhere through the Access 2 system using the eight function buttons across the bottom of the Main Menu (see Figure 1-15). These buttons are direct routes to the functions you perform most frequently.

The Main Menu function buttons are available from other screens when you use the Menu tab. The Menu tab displays along the right edge of every screen except the Main Menu.



0622C.bmp

Figure 1-15 Main Menu

Main Menu Function Button Description

Sample Manager F1 Select to display the Sample Manager screen. You use this screen to:

• Define racks in the system, load or unload them, or delete them from the system

• Add samples to, or remove samples from racks

• Display the Test Requests screen to enter test requests and check on their progress

• Request maintenance routines

• Review tests on the Work Pending screen

For more information see Chapter 3: Sample Management and see Chapter 4: Sample Processing.

Table 1-16 Main Menu Options



Test Results F2 Select to display the Test Results screen. You use this screen to:

• View test results and associated result flags

• Print test result reports or copy test result data to a disk

• Rerun a test after reviewing its results

For more information about Test Results, see Chapter 5: Test Results.

Supplies F3 Select to display the Supplies screen. You use this screen to:

• Check the status of all system supplies

• Replenish bulk supplies

• Load and unload reagent packs and review the reagent inventory

For more information about Supplies, see Chapter 2: Supplies.

Quality Control F4 Select to display the Quality Control screen. You use this screen to:

• Set up quality controls

• Review, compare, or print quality control information

For more information, see Chapter 7: Quality Controls.

Calibration F5 Select to display the Calibration screen. You use this screen to:

• Set up calibrators

• View the results of assay calibrations

• Print calibration reports

For more information, see Chapter 6: Assay Calibrations.

Maintenance Review F6 Select to display the Maintenance Review screen. You use this screen to:

• Review system temperatures

• Run or disable the Utility Assay

• Review system check results

For more information, see Chapter 8: Routine Maintenance.


Table 1-16 Main Menu Options (continued)



Main Menu Workflow

Select one of the Main Menu function buttons to display its associated screen. Across the bottom of the screen you will see another row of function buttons. You can select these buttons to perform an action or display a menu with additional function buttons.

The following flowchart (see Figure 1-17) outlines the workflow for each of the Main Menu function buttons.

Diagnostics F7 Select to display the Diagnostics menu. You use this menu to:

• Initialize the system or align and home devices

• View information from various instrument sensors

• Perform diagnostic or troubleshooting procedures as instructed in system documentation or by Technical Support

For more information, see Chapter 5: Diagnostics in the Reference

Manual.

Configure F8 Select to display the Configure menu. You use this menu to:

• Set up system and LIS information, test result ranges, test panels, derived results, and reflex tests for your laboratory

• Enable and disable tests and test panels

• Set up or change the system password

• Back up and restore system data

For more information, see Chapter 4: System Configuration in the Reference Manual.


Table 1-16 Main Menu Options (continued)




0863D.wmf

Figure 1-17 Main Menu Work Flow

CalibrationF5

SuppliesF3

Quality ControlF4

Sample ManagerF1

Maintenance ReviewF6

Test ResultsF2

F1 Load a RackF2 Work PendingF3 Test RequestF4 Maintenance RequestF6 Get Selected RackF7 Clear Selected RackF8 Change Rack ID

F1 FilterF2 FindF3 Rerun TestF4 Sample DetailsF5 Send to LISF6 Copy to DiskF7 Print

F8 More Options

F1 Load Reagent PackF2 Unload Reagent PackF4 Load RVsF5 Change SubstrateF6 Change RV Waste BagF7 Reagent Inventory

F1 FilterF2 Review Chart and DataF3 Compare ChartsF4 Delete ComparisonF5 QC SetupF7 Print

F1 FilterF2 Review DataF5 Calibrator SetupF6 DeleteF7 Print

F2 System ChecksF5 Run Utility AssayF6 Enable/Disable Utility AssayF7 Print

F1 Refresh ScreenF2 Configure ScreenF3 Delete Data

F1 Load Reagent PackF2 Unload Reagent PackF5 Delete PackF7 PrintF8 Filter

DiagnosticsF7

ConfigureF8

F1 Initialize SystemF2 Prime FluidicsF3 Volume ChecksF4 Device Diagnostics

F5 LISF6 Copy to DiskF7 Diagnostic Reports

F1 MechanicsF2 Analog DevicesF3 Digital DevicesF4 LuminometerF5 UltrasonicsF6 ExerciserF7 Calibrate Incubator Belt

F1 LIS SetupF3 Loopback CheckF4 Query for Test RequestsF6 Copy to DiskF8 Clear Screen

F1 System Setup

F2 Tests

F3 Test PanelsF4 Derived ResultsF5 Reflex TestsF6 LISF7 PC AdminF8 About Access 2

F1 System RevisionsF2 Bar Code Reader SetupF3 Set Workgroup Date/TimeF5 Password SetupF7 Reports Setup

F1 FilterF2 Edit UnitsF3 RangesF4 Gray ZoneF5 SpecialF7 PrintF8 Update APF

F1 Load Rack / Get/Edit RackF2 Delete SampleF3 Show/Hide Test MenuF4 Test ResultsF5 Request QCF6 Request CalibrationF7 Clear All SamplesF8 More Options

F1 ReportF2 Completed Samples

F1 Scheduled BackupF2 Immediate BackupF3 Eject TapeF4 RestoreF5 Auto-Delete SetupF8 Shut Down PC


Common Screen Elements

The Access 2 system displays certain elements on every screen so you can continuously monitor the system’s status (see Figure 1-18). The labels in the example screen below are described in the following sections.

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Figure 1-18 Common Access 2 System Screen Elements

System Modes

The Access 2 system has four system modes (see Table 1-19) that indicate the operating state of the system. The current mode is displayed in the upper left corner of each screen. When the system is in the Running mode, the estimated completion time for the requested function is displayed as a text line above the three system command buttons. Additional system messages are displayed at various times at this location.

Menu

System ModeSystem Status Buttons

SystemCommand

Buttons

StatusLine

Tab

Back Tab

Function Buttons

Scroll Bar

Mode Screen Display Description

Ready The system is ready to begin processing samples.

Table 1-19 System Modes



System Command Buttons

You use the three system command buttons (see Table 1-20) to run, pause, and stop the Access 2 instrument.

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

Paused The system continues current test processing, but no new tests are scheduled.

Not Ready

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

Mode Screen Display Description

Table 1-19 System Modes (continued)

Button Screen Display

Description

Run Select to process samples or run a maintenance routine.

Pause Select to pause the instrument. The system stops pipetting after it finishes pipetting the current sample. Processing continues on samples already in progress.

Stop Select to stop the instrument. The system stops processing and cancels any tests in progress.

Table 1-20 System Command Buttons




There are ten system status buttons. You can use these buttons to:

• Monitor the status of on-board supplies

• Review quality control results

• Display test requests that are on the work pending list

• View the Event Log for information about an event that occurred during processing

• Access the Help system

Most buttons are color coded to alert you if a supply level requires your attention, a sample processing issue exists, or if the instrument has recorded a system event. Under normal operating conditions the button color will be neutral. The color of some buttons can change to yellow to indicate a caution condition, or red to indicate a warning condition. The Help button color is always neutral.

For more information about consumable supplies, see Chapter 2: Supplies.

System Status Button

Description Button Colors

Wash Buffer Select to view the status of the wash buffer bottle. You can change the wash buffer bottle at any time during sample processing.

For more information about how to change wash buffer, see Section 2.2: Wash Buffer.

Red The wash buffer reservoir is almost empty, and no new tests can be scheduled. You must change the wash buffer bottle to continue processing tests.

Liquid Waste Select to view the status of the liquid waste bottle. You can change the liquid waste bottle at any time during sample processing.

For more information about how to change the liquid waste bottle, see Section 2.3: Liquid Waste.

Red

The liquid waste bottle is full, and no new tests can be scheduled. You must change the liquid waste bottle to continue processing tests.

Table 1-21 System Status Buttons



Substrate Select to display the Supplies screen to check the level of on-board substrate, or change the substrate bottle. You can only change the substrate bottle while the system is in the Ready mode.

For more information about how to change the substrate bottle, see Section 2.4: Substrate.

Yellow

The system can process 60 or fewer test requests with the remaining substrate. Change the bottle at your next opportunity.

Red

The substrate bottle is empty, and no new tests can be scheduled. You must change the substrate bottle to continue processing tests.

Reaction Vessels (RVs)

Select to display the Supplies screen to check on the RV supply, or load an RV cartridge. You can load RVs at any time during sample processing.

For more information about how to load RVs, see Section 2.5: Reaction Vessels (RVs).

Yellow

The system can process 60 or fewer test requests with the remaining RVs. Load an RV cartridge now, or at your next opportunity.

Red

The system can process 28 or fewer test requests with the remaining RVs, and no new tests can be scheduled. You must load an RV cartridge to continue processing tests.

RV Waste Bag Select to display the Supplies screen to check on the RV waste bag capacity, or change the RV waste bag.

For more information about how change the RV waste bag, see Section 2.6: Reaction Vessel Waste Bag.

Yellow

The system can process 60 or fewer test requests with the remaining capacity in the waste bag. Change the RV waste bag at your next opportunity.

Red

The RV waste bag is full, and no new tests can be scheduled. You must change the waste bag to continue processing tests.

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

For information about quality controls, see Chapter 7: Quality Controls.

Red

A QC result is not within the acceptable range of expected values. You should review this result as soon as possible.



Table 1-21 System Status Buttons (continued)



Event Log Select to display the Event Log screen for information about events generated by the Access 2 system. From the Event Log screen you can also display troubleshooting information about caution or warning events.

For information about the Event Log, see Chapter 6: Event Log in the Reference Manual.

Yellow

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

Red

The system has generated a warning event, indicating a serious fault or error condition has occurred.

Work Pending Select to display the Work Pending screen for information about samples for which the system cannot schedule tests. The Work Pending screen allows you to navigate to the Sample Manager screen to load samples or delete sample requests.

For more information about the Work Pending screen, see Chapter 4: Sample Processing.

Yellow

A sample required condition has occurred. You should load the required sample, or delete it from the work list.

Supplies Required Select to display the Supplies Required screen for information about supply and calibration conditions. You can correct most conditions from the Supplies Required screen.

For more information about the Supplies Required screen, see Chapter 4: Sample Processing.

Yellow

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

Help Select to display specific information about the screen you are on, or to navigate to a picture with descriptions for the screen, to a list of related topics, or to any topic within Help.

The Help button color is always neutral.



Table 1-21 System Status Buttons (continued)



Scroll Bar The scroll bar displays along the right side or bottom of some screens. Use the scroll bar to view areas that are out of the normal viewing area of the screen. Select the arrows at either end of the scroll bar to move through the screen line-by-line, or drag the icon within the scroll bar to pass through the screen rapidly.

Arrow Buttons Arrow buttons are displayed at either end of some horizontal and vertical data labels. Select the arrow buttons to view data that is out of the normal viewing area of the screen, like the arrows buttons at either end of a scroll bar.

When there is a blue line cursor over a data point on the screen, that point is selected. Selecting an arrow button moves the cursor and selects the next data point in the direction of the arrow. Additional data associated with a point may be available when a data point is selected.

Back and Menu Tabs

The Back and Menu tabs are on all screens except the Main Menu. Select the Back tab to display the previous screen. Select the Menu tab to display the Main Menu function buttons.

Function Buttons

The Access 2 system displays a row of eight function buttons across the bottom of each screen. Selecting a function button performs an action or displays a menu of additional function buttons.

Function buttons vary from screen to screen, according to the operations you can perform on each screen.

0649A.bmp 0650A.bmp

Figure 1-22 Back and Menu Tabs



2014 Beckman Coulter, Inc. 1-25

Information Fields

Some screens require that you enter pertinent information into a field. You can only enter information if the field is available.

NOTE

Do not enter a quotation mark (") in an available field. Although some fields may accept quotation marks, characters to the right of the quotation mark may not print on reports.

Function Button Example

Description

A function button is available when its text is colored black. You can select the button to perform the function indicated in the text message.

A function button is unavailable when its text is colored gray. You cannot select the button at this time.

An unlabeled function button does nothing on the screen.

A function button with a small arrow has an associated menu. You can select the button to display the menu with additional function buttons.

Table 1-23 Function Button Examples

P/N B14251D 9/14


Status Line The status line displays the system ID and the current date and time. It may also display other information, such as what activity the system is currently performing, or what to enter in a selected field.

System Navigation

The Access 2 system has three navigation methods that you can use in any combination:

• Touching part of the screen using the tip of your finger or fingernail.

• Clicking the left mouse button to select an item on the screen.

• Pressing a keyboard equivalent such as a function key, tab key, or arrow key to select a field or other item on the screen.

Keyboard Equivalents

The following table lists the equivalent keystrokes you can use to perform common functions on the Access 2 system.

Field Example Description

When a field has a recessed appearance and the background color is different than the color of the screen (beige), you can enter or change information in the field.

When the field’s background color is the same color as the screen (beige), you cannot enter or change information in the field.

A field with a down arrow attached to it has a list of several options for you to select from. Only selections from the list can be entered in the field.

Table 1-24 Information Field Examples



Select and Enter

The word select is applied throughout the system documentation to signify using any of the three navigation methods to move through the screens, or to make system choices.

The word enter is applied throughout the system documentation to signify putting information into a field. Depending on the options available for the field, you can enter information using one of the following methods:

• Type the information from the keyboard.

• Select the information by checking a box or choosing an item from a list. This will enter the information you selected into the appropriate field.

• Scan bar coded information with the handheld bar code reader.

Common Windows

The Access 2 system displays a window to provide information, ask you to respond to a question, prompt you to perform an action, or confirm that you want the system to perform an action. Illustrations of many windows, particularly those that are complicated, are included in the Help procedures.

Action Keyboard Equivalent

Perform the indicated function or go to the indicated screen

[F1] - [F8]

Go to the Main Menu [F9]

Check supplies [F10]

Start sample processing [F11]

Display the Help system [F12]

Go back to previous screen [Esc]

Display a list in a field [Down Arrow]

Pause the system [Pause]

Stop the system [Shift]-[Pause]

Print a screen or window [Print Screen]

View the Event Log [Scroll Lock]

Table 1-25 Keyboard Equivalents



0920A.bmp.

Figure 1-26 OK/Cancel/Help Window Example

The OK F1, Cancel F8, and Help F12 buttons are common buttons. This section provides an explanation of these buttons. Common buttons will not be explained again in the remaining chapters of the Operator’s Guide or Reference Manual.

You select OK F1 to:

• Save and apply changes and exit the window.

• Copy the selected information to the named file and exit a Copy window.

• Print the selected report and exit a Print window.

• Delete the selected information and exit a Delete window.

You select Cancel F8 to:

• Exit a window without performing the task. If you have changed selections in the window, the changes are not saved or applied. In a Print window no report is printed.

You select Help F12 to:

• Display procedural information about the window you are in.



Reports You can print reports as well as the displayed screen or window from the Access 2 system software.

The system provides the following reports:

• Alignment Report

• Calibration Reports

• Continuous Sample Report

• Derived Results Setup Report

• Event Log Report

• Incubator Belt Calibration Report

• Level Sense Report

• Patient Report

• QC Reports

• Ranges Reports (Reference, Critical, and LIS Ranges)

• Reagent Inventory Report

• Reflex Tests Setup Report

• Sample Report

• Selected Test Results Report

• Supplies Required Report

• System Check Report

• Temperature Report

• Test Panels Setup Report

• Tests Setup Report

• Work Pending Report

Report Headers and Standard Text

The Access 2 system prints the same information at the top and bottom of all reports (see Figure 1-27).

• Report header information (at the top of the report) is set up when you configure your system and is specific for your laboratory.

• Report information at the bottom of the report is standard for all reports and laboratories.

The first page of every report contains a complete header, and subsequent pages of the report contain an abbreviated header.

NOTE

If information about a sample or a patient continues onto another page, the system repeats the sample or patient ID at the top of that page.

For more information about setting up report header information, see Section 4.2: System Setup in the Reference Manual.



0745B.eps

Laboratories, Inc. Laboratory A

123 Lake Street Report Name Townsville, ST 3333

Jane Smith Access 2 Immunoassay System S/N 501240

Page 1 of 1 Technologist Printed 10-10-00 2:43pm

6

9

10

7

1

4 5

8

3

2

11

101-555-2323 ext. 109

QNS = sample quantity not sufficient, ORL = result below reference range, ORH = result above reference range, LEX = reagent pack lot expired

1213

1 Instrument Serial Number (S/N) if Report Type is Specific to One Instrument

2 Product Name (Access 2 Immunoassay System)

3 Report Title

4 Institution

Figure 1-27 Report Headers and Standard Text



5 Laboratory Name

6 Laboratory Street Address

7 Laboratory City, State, Zip Code

8 Laboratory Telephone Number

9 Laboratory Director

10 Flag Short Descriptions (Applies to Result Flags on the Report)

11 Current Page Number and Total Number of Pages

12 Date and Time of Printing

13 Technologist Signature Line

Figure 1-27 Report Headers and Standard Text (continued)


Access 2 Operator’s Guide 2: Supplies

2Supplies

2.1 Supplies ...........................................................................................................2-3

Manually Scanning Bar Codes..........................................................................2-4

Supplies Screen .................................................................................................2-6

2.2 Wash Buffer ................................................................................................... 2-10

Changing the Wash Buffer Bottle ................................................................... 2-11

2.3 Liquid Waste.................................................................................................. 2-13

Changing the Liquid Waste Bottle.................................................................. 2-15

2.4 Substrate ........................................................................................................ 2-17

Changing the Substrate Bottle......................................................................... 2-19

2.5 Reaction Vessels (RVs) ...............................................................................2-24

Loading RVs ................................................................................................... 2-25

2.6 Reaction Vessel Waste Bag .......................................................................2-28

Changing the RV Waste Bag .......................................................................... 2-29

2.7 Reagent Packs ............................................................................................. 2-31

Loading a Reagent Pack.................................................................................. 2-33

Unloading a Reagent Pack ..............................................................................2-37

Retrieving Misplaced Packs............................................................................ 2-39

2.8 Reagent Inventory ....................................................................................... 2-40

Reagent Inventory Screen ...............................................................................2-42


2: Supplies Access 2 Operator’s Guide

Applying a Filter to the Reagent Inventory Screen......................................... 2-45

Deleting a Reagent Pack ................................................................................. 2-48

Printing the Reagent Inventory Report ........................................................... 2-49


Access 2 Operator’s Guide 2.1: Supplies

2.1Supplies

Access 2 system supplies are the consumables and waste containers that you must change to continue operating the system. Consumables consist of wash buffer, substrate, reaction vessels (RVs), and reagent packs. Waste containers consist of the liquid waste bottle and the RV waste bag.

The system keeps track of the following supply status information during processing:

• When the wash buffer reservoir is empty

• When the liquid waste bottle is full

• When the substrate bottle was opened, when it will expire, and how many tests can be processed with the current supply

• How many RVs are available

• How many RVs will fit in the RV waste bag

• Which reagent packs are on board and off board, when each reagent pack was first punctured, when the reagent lot will expire, how many tests can be processed with the current supply in each pack, and which packs are in use.

• When each calibration will expire

• Which reagent packs are in inventory for all instruments in a workgroup

The system displays and continuously updates supply status information during processing.

The system status buttons for supply conditions at the top of every screen change color to indicate the current supply status. You can select them to get detailed supply information and load supplies or change waste containers.

For more information about the system status buttons, see Section 1.3: Software Overview.

For information about ordering supplies, see the instrument Instructions for Use.


2.1: Supplies Access 2 Operator’s Guide

Supply Status

The system status buttons for supply conditions are located at the top of every Access 2 system screen. These buttons alert you to the status of on-board supplies and waste containers by changing color if a supply level requires your attention. When a button changes color, you can select it to show the screen or window you will use to change the supply or change the waste container.


NOTE

You do not use the system screens, windows, or function buttons when you change the wash buffer or liquid waste bottles. You do need to use the system screens, windows, or function buttons according to the procedures, when you change the substrate or RV waste bag, or load reaction vessels (RVs) or reagent packs.

Manually Scanning Bar Codes

Use the external or handheld bar code reader to enter information provided on the following types of bar codes:

• Access substrate bar code label

• Access calibrator card bar codes

• Reagent pack bar code labels

• Sample container bar code labels

Your instrument is equipped with either a bar code wand or another handheld bar code reader. Use these procedures to scan a bar code with the bar code reader that you have.

Scanning a Bar Code with the Bar Code Wand

Be sure that the cursor is positioned in the appropriate field of the window or screen before scanning the bar code.

Place the tip of the wand at an angle on the quiet zone of the bar code. For more information, see Section 2.3: Performance Characteristics in the Reference

Manual. When the wand is properly angled, you will see a small, oval pattern of light extending from the tip of the wand within the quiet zone.

1

2



Move the tip of the wand smoothly and rapidly across the bar code to the quiet zone on the other side. The system beeps after it successfully reads the 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.

Look at the window or screen and verify that the bar code information is correctly displayed in the appropriate field.

• If the information is not correct and the bar code is not damaged in any way, select Cancel F8 and scan the bar code again.

• If the information is not correct and the bar code is damaged, delete the information in the Bar Code field and type the bar code characters printed underneath the bar code.

Select Done F1.

Scanning a Bar Code with the Other Handheld Reader

Be sure that the cursor is positioned in the appropriate field of the window or screen before scanning the bar code.

Aim the bar code reader at the bar code label. Hold the reader approximately 1 to 8 inches (2.5 to 20.3 cm) from the label.

Squeeze the trigger and center the red light (indicating the scanning area) within the vertical lines of the bar code. Adjust the reader distance to extend the light just beyond the length of the bar code, on both ends.

When the system beeps (and for some readers, a green dot is displayed on the bar code), release the trigger.

Look at the window or screen and verify that the bar code information is correctly displayed in the appropriate field.

• If the information is not correct and the bar code is not damaged in any way, select Cancel F8 and scan the bar code again.

• If the information is not correct and the bar code is damaged, delete the information in the Bar Code field and type the bar code characters printed underneath the bar code.

Select Done F1.

3

4

5

1

2

3

4

5

6



Supplies ScreenYou use the Supplies screen to:

• Check the status of all system supplies

• Replenish the supply of substrate and RVs

• Change the RV waste bag

• Load and unload reagent packs

• Display the Reagent Inventory screen

To get to this screen from the Main Menu, select Supplies F3, or from any screen, select the Substrate, RVs, or RV Waste Bag button.

0631D.bmp

Figure 2-1 Supplies Screen

Substrate Button

0575A.bmp

RVs Button

0576A.bmp

RV Waste Bag Button

0577A.bmp



Reagent Pack Button

(24 Buttons) Correspond to the 24 available slots in the reagent carousel of the instrument. Sorted alphabetically by pack name down a column, then from left to right. The reagent pack button turns red and the reagent pack name is displayed in white when a pack is rejected during reagent pack monitoring.

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

• Reagent Pack Name

(Button label) The same as the test name, except in the case of multi-constituent tests, such as Folate and RBC Folate. The RBC Folate test uses the Folate reagent pack, so there is no Reagent Pack button for RBC Folate.

• Tests Left

(Field) The number of tests remaining in the pack, updated as the system uses the reagent. This field turns yellow when there are 10 tests or fewer remaining for all on-board packs with the same lot number, or if the open pack expiration date is within three days. The field turns red when there are zero tests left, or the pack is past the open pack expiration date.

• Lot Number

(Field) The lot number of the reagent pack. This field turns yellow when the pack lot or the calibration for the lot will expire within three days. The field turns red when the calibration for the lot is expired or if no calibration exists. The system tracks both lot and open pack expiration dates.

NOTE

For assay calibrations that expire within three days of being generated, the field does not turn yellow. The field goes straight to red when the calibration is expired.

• In-Use Icon

(Padlock) If the system is processing samples and the reagent pack is scheduled for use, the system displays a padlock icon and disables the Unload Reagent Pack F2 button to prevent you from removing the

pack. You cannot remove in-use packs until the system aspirates the reagent for the current run.

The system updates the Reagent Pack buttons when you load and unload packs.

RV Supply (Field) Displays the number of RVs available. The system updates this number as it uses RVs.

This field turns yellow when there are 60 or fewer RVs available. This field turns red when there are 28 or fewer RVs available.

Table 2-2 Supplies Screen Descriptions



RV Waste (Field) Displays the number of RVs that can fit in the waste bag. The system updates this number as it ejects RVs.

This field turns yellow when there is room for 60 or fewer RVs in the waste bag. The field turns red when the waste bag is full.

Substrate (3 Fields) Displays the following summary information about substrate:

• Substrate

(Field) Displays the number of tests the system can process with the current substrate supply. This field turns yellow when the system can process 60 or fewer tests. The field turns red when the substrate bottle is empty. The system updates this number as it uses substrate.

• Lot Number

(Field) Displays the lot number of the substrate. This field turns yellow when the lot will expire within three days. This field turns red when the lot expires.

• Days Until Expiration

(Field) Displays the number of days until the substrate expires, based on when the bottle was opened. This field turns yellow when the substrate will expire within three days. This field turns red when the substrate expires.

Load Reagent Pack F1

(Button) Select to display the Load Reagent Pack window.

When the instrument presents an empty pack position on the reagent carousel, you can load the reagent pack. When you are done, the system adds a new Reagent

Pack button to the Supplies screen.

For more information about loading reagent packs, see Section 2.7: Reagent Packs.

Unload Reagent Pack F2

(Button) Select to unload a reagent pack.

When the system presents the pack, you can remove it from the reagent carousel. The system removes the Reagent Pack button from the Supplies screen and retains the lot number, expiration date, and number of tests left for the pack, so you can reload the pack on any instrument in the workgroup. If the pack is empty or rejected due to reagent pack monitoring, the system automatically deletes the pack from inventory.

For more information about unloading reagent packs, see Section 2.7: Reagent Packs.

Table 2-2 Supplies Screen Descriptions (continued)



Load RVs F4 (Button) Select to load RVs.

The system displays a message to wait while it prepares for RV loading. It retracts the rake, releases the latch on the RV load door, then displays the message that you can load a cartridge of RVs. When you are done, the system updates the RV count on the Supplies screen.

For more information about loading RVs, see Section 2.5: Reaction Vessels (RVs).

Change Substrate F5

(Button) Select to change the substrate bottle.

When the Change Substrate window is displayed, you can enter bar coded information for the new bottle. The system retains the substrate information and warns you if you try to load an expired bottle. When you are done changing the substrate, the system prompts you to prime the substrate and updates the substrate information on the Supplies screen.

For more information about changing substrate, see Section 2.4: Substrate.

For more information about priming substrate, see the Priming the Fluidics procedure in Section 5.3: Prime Fluidics of the Reference Manual.

Change RV Waste Bag F6

(Button) Select to change the RV waste bag.

When you are done, the system updates the RV waste bag information on the Supplies screen.

For more information about changing the RV Waste Bag, see Section 2.6: Reaction Vessel Waste Bag.

Reagent Inventory F7

(Button) Select to display the Reagent Inventory screen. You use this screen to:

• View the reagent inventory


• Delete a reagent pack from inventory

• Print the Reagent Inventory Report

• Apply a filter for review or printing the reagent inventory

Table 2-2 Supplies Screen Descriptions (continued)


2.2: Wash Buffer Access 2 Operator’s Guide

2.2Wash Buffer

WARNINGWash buffer contains ProClin* 300 preservative, which may cause sensitization by skin contact. After contact with skin, wash immediately with soap and water. Wear suitable gloves.

Wash buffer is buffered solution the Access 2 system uses to clean the main pipettor and probes, and to remove unbound material during test processing. The system monitors the volume of on-board wash buffer with a float level sensor.

You can change the wash buffer bottle at any time. Because of the internal reservoir, the system continues processing samples even when you remove the wash buffer bottle.



* ProClin is a trademark of Rohm & Haas company or its subsidiaries or affiliates.

The wash buffer bottle drains into an internal wash buffer reservoir. When the wash buffer bottle is visibly empty, but before the Wash Buffer button turns red, you should change the empty bottle with a full one. There will still be some buffer in the reservoir. If you wait until the button is red, the system schedules no new tests because the internal reservoir is almost empty. The Wash Buffer button does not turn yellow.

Wash Buffer Button

0573A.bmp


Access 2 Operator’s Guide 2.2: Wash Buffer

0588B.wmf

Figure 2-3 Changing the Wash Buffer Bottle Flowchart

Changing the Wash Buffer Bottle

Use this procedure to change the wash buffer bottle (see Figure 2-4).

WARNINGWash buffer contains ProClin 300 preservative, which may cause sensitization by skin contact. After contact with skin, wash immediately with soap and water. Wear suitable gloves.

Mix the contents of the new wash buffer bottle by gently inverting the sealed bottle 3 or 4 times.

Remove the cap and the inner seal from the new bottle.

Lift the empty bottle from the reservoir in the fluids tray on the left side of the instrument.

CAUTION

To avoid contaminating the wash buffer, do not touch any part of the dispense cap assembly that enters the reservoir. Handle the dispense cap assembly only by screw cap, not the nozzle.

Unscrew the wash buffer dispense cap assembly from the empty bottle.

Remove empty bottle

Gently invert newwash buffer bottle

3 or 4 times

Remove cap and innerseal from new bottle

Attach dispense capassembly to new bottle

Turn new bottle upsidedown and place intoreservoir receptacle

Remove dispensecap assembly from

empty bottle

1

2

3

4


2.2: Wash Buffer Access 2 Operator’s Guide

Screw the dispense cap assembly on the new bottle.

Turn the new bottle upside down and place the dispense cap assembly into the reservoir receptacle.

NOTES

• The wash buffer will flow into the wash buffer reservoir as needed. DO NOT squeeze the bottle or excess buffer may be forced into the reservoir causing it to overflow.

• The sides of the bottle may cave in as it drains. This is normal.

0225F.eps

1 Wash Buffer Bottle

2 Dispense Cap Assembly (Wash Buffer Valve Assembly)

2a Nozzle

2b Screw Cap

3 Wash Buffer Reservoir

4 Reservoir Receptacle

Figure 2-4 Changing the Wash Buffer Bottle

5

6

1

2

4

3

2

2a2b


Access 2 Operator’s Guide 2.3: Liquid Waste

2.3Liquid Waste

Liquid waste is any fluid removed from the Access 2 system.

WARNINGConsider the liquid waste potentially infectious. Handle and dispose of the liquid waste according to proper laboratory procedures. Proper hand, eye, and facial protection is required.

The liquid waste bottle collects liquid waste. Each instrument ships with two waste bottles. This allows you to cycle containers, with one installed on the instrument while you decontaminate the other. For your convenience, you can order more waste bottle assemblies.

NOTE

The liquid waste drain kit may be used to replace the waste bottle and to direct liquid waste to a floor drain. As site conditions vary, Beckman Coulter requires that you consult with Technical Support to determine whether your system can be fitted with the kit.


For more information about system status buttons, see Section 1.3: Software Overview.

The system monitors the volume in the on-board liquid waste bottle with a weight sensor. The Liquid Waste button turns red when the waste bottle is full. The system will not schedule any new tests until you change the liquid waste bottle. You can change the liquid waste bottle any time, even during processing, and preferably before it is full. The Liquid Waste button does not turn yellow.

Liquid Waste Button

0574A.bmp


2.3: Liquid Waste Access 2 Operator’s Guide

0589C.wmf

Figure 2-5 Changing the Liquid Waste Bottle Flowchart

Loosen cap of fullliquid waste bottle

Decontaminatecontents of full liquid

waste bottle

Dispose of liquid wasteand rinse bottle

thoroughly

Store clean bottle forfuture use

Remove bottle cap andinsert in clean bottle

Remove full liquidwaste bottle and place

clean bottle in fluids tray

StoppedProcessingsamples?

Yes

Connect quickdisconnects to empty

liquid waste bottle

Release the quickdisconnects from full

bottle

No


Access 2 Operator’s Guide 2.3: Liquid Waste

Changing the Liquid Waste Bottle

Use this procedure to change the liquid waste bottle. To minimize contact with liquid waste, do not change the liquid waste bottle while the system is processing samples.

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

Loosen the liquid waste bottle cap slightly to release any pressure.

If the system is not processing samples, press the button on the quick disconnects while pulling on the tubing to detach the tubing from the liquid waste bottle cap (see Figure 2-6). Immediately, connect the quick disconnects to the cap of a clean liquid waste bottle.

(Optional) If the system is processing samples, remove the liquid waste bottle cap and immediately attach it to a clean liquid waste bottle.

NOTE

If a clean liquid waste bottle is not immediately available, put the liquid waste bottle cap into a temporary container to prevent spills.

Remove the full liquid waste bottle and place the clean liquid waste bottle in the fluids tray.

Decontaminate the contents of the full liquid waste bottle according to proper laboratory procedures before disposing of the liquid waste.

Dispose of the liquid waste.

Rinse the just-emptied liquid waste bottle thoroughly by filling it with tap water and discarding the contents to remove any traces of the decontaminant.

WARNINGThoroughly flush any decontaminant from the liquid waste bottle before you store the liquid waste bottle. If you reinstall the liquid waste bottle before you flush it, any remaining decontaminants may react with chemicals pumped into the liquid waste bottle and the resulting chemical reactions can create gases harmful to you or the instrument.

Store the clean liquid waste bottle for future use.

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3

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7


2.3: Liquid Waste Access 2 Operator’s Guide

0229C.eps

1 Liquid Waste Bottle

2 Quick Disconnects

Figure 2-6 Liquid Waste Bottle

1

2


Access 2 Operator’s Guide 2.4: Substrate

2.4Substrate

In Access 2 assays, the substrate is a dioxetane-based chemiluminescent compound that emits light in response to the amount of alkaline phosphatase (enzyme) it is exposed to. The system monitors the volume in the on-board substrate bottle. Each bottle contains 130 mL of substrate, which can be used to perform up to 600 tests.

The fluids tray can accommodate two substrate bottles. The bottle in use is connected to the substrate tubing. Another bottle can be stored in the tray to equilibrate to room temperature prior to use, for the time specified in the substrate reagent instructions for use. The substrate bottle in use can occupy either the left or right tray position (see Figure 2-10).

All Access substrate bottles are labeled with a bar code. The Access 2 system tracks the lot number, open bottle expiration date, serial number, and tests left. The system also checks the substrate quantity and expiration date prior to sample processing, and notifies you if supplies are required. You can override an expired supply condition, but any test results generated with expired substrate are flagged.

For more information about checking and overriding supply conditions, see Section 4.2: Supply and Calibration Conditions.

For more information about system status buttons, see Chapter 1: System Overview.

When the system can process 60 or fewer tests with the current supply of substrate, the Substrate button turns yellow. When the substrate bottle is empty the button turns red, and the system cannot start processing samples until you connect a new bottle of substrate. You can only change the substrate bottle while the system is in the Ready mode.

Substrate Button

0575Ac.bmp


2.4: Substrate Access 2 Operator’s Guide

0505A.wmf

Figure 2-7 Changing the Substrate Bottle Flowchart

Supplies

any screen

Change SubstrateF5

DoneF1

Change Substrate

Scan the new,equilibrated substrate

bottle

Replace cap on newsubstrate bottle

with cap from oldsubstrate bottle

Discard empty bottleand equilibrate newbottle prior to use

YesF1

System primes thesubstrate fluidic lines



Changing the Substrate Bottle

Use this procedure to change the substrate bottle.

CAUTION

Do not combine partial bottles of substrate.

Be sure the system is in the Ready mode, then go to the Supplies screen. To get to this screen from any screen, select the Substrate button.

Select Change Substrate F5.

The Change Substrate window is displayed. You must always use the Change Substrate window to change substrate to be sure the system can properly monitor the substrate supply.

0662A.bmp

Figure 2-8 Change Substrate Window

Bar Code (Field) Using either the handheld bar code reader or the keyboard, enter the bar code ID of the substrate bottle.

Lot Number (Field) Displays the lot number of the substrate bottle.

Serial Number (Field) Displays the unique serial number of the substrate bottle.

Table 2-9 Change Substrate Window Descriptions

1

2



Pick up the equilibrated (new) substrate bottle and enter the bar code by scanning the bottle with the handheld bar code reader or by typing the characters in the Bar Code field.

The window displays the lot number, serial number, expiration date, and number of tests left.

NOTES

• To avoid contaminating the substrate, only touch the tubing or inside of the substrate cap with a clean, lint-free tissue. Do not allow the substrate tubing to come in contact with any surface.

• Never combine partial bottles of substrate. Combining partial bottles will cause improper monitoring of the substrate supply, and may contaminate the substrate system.

For information on scanning the bar code, see the Manually Scanning Bar Codes procedure in Section 2.1: Supplies.

Remove the cap from the new, equilibrated substrate bottle and discard it (see Figure 2-10).

Expiration Date (Field) Displays the expiration date of the substrate bottle.

Tests Left (Field) Displays the number of tests that can be run using the substrate bottle.

Table 2-9 Change Substrate Window Descriptions (continued)

3

4



0228C.eps

Unscrew the substrate supply cap from the bottle in use and immediately screw it onto the new bottle.

Determine the configuration of your substrate supply cap assembly (see Figure 2-11).

1058A.eps

1 Substrate Bottle in Use

2 Substrate Bottle Equilibrating to Room Temperature for Next Use

Figure 2-10 Substrate Bottles

1 2

5

6

1 2

3



If your substrate supply cap contains a fitting lock, proceed to the next step. Otherwise, confirm the fittings on the substrate supply cap are finger-tight (see Figure 2-12).

1059A.eps

Figure 2-12 Finger Tighten Substrate Supply Cap Fittings

Put the new bottle back in the fluids tray.

Select Done F1.

The system updates the substrate information on the Supplies screen and displays a message about priming the substrate.

Select Yes F1.

The system primes the substrate fluidic lines.

Remove the empty substrate bottle from the fluids tray and discard it.

Put an unopened bottle of substrate in the fluids tray so it can equilibrate to room temperature.

1 Substrate Supply Cap Without Fitting Lock

2 Substrate Supply Cap With Fitting lock

3 Fitting Lock (black)

Figure 2-11 Substrate Supply Cap Configurations

7

8

9

10

11

12



NOTE

Do not store substrate at room temperature for longer than the limits specified in the reagent instructions for use. Do not loosen or remove the cap on the substrate bottle while it is equilibrating.

(Optional) To track the stability of the substrate, monitor the Substrate fields on the Supplies screen.


2.5: Reaction Vessels (RVs) Access 2 Operator’s Guide

2.5Reaction Vessels (RVs)

During an Access 2 test, the chemical reaction occurs in a container called a reaction vessel (RV). Each test uses one or two RVs. RVs come in cartridges of 98. You can load up to 3 cartridges at a time for a maximum capacity of 294 RVs.

The system monitors the number of on-board RVs.


• When there are 60 or fewer RVs available, the RVs button turns yellow.

• When there are 28 or fewer RVs available, the RVs button turns red.

• When no RVs are available, the system cannot process another sample until you load a new RV cartridge onto the instrument.

RVs Button

0576Ac.bmp


Access 2 Operator’s Guide 2.5: Reaction Vessels (RVs)

0504A.wmf

Figure 2-13 Loading RVs Flowchart

Loading RVs Use this procedure to load a cartridge of RVs onto the instrument.

NOTES

• You can load only full cartridges of RVs. If you try to load RVs when the instrument only has room for a partial cartridge, the system displays a message.

• If the system is processing samples and has one row or fewer RVs left when you try to load more, the system displays a message. You must wait until the instrument stops before you load the new cartridge.

• RVs can fall between the rake and the wall of the incubator if you do not load RVs properly by selecting Load RVs F4 from the Supplies or Supplies Required screen.

Go to the Supplies screen. To get to this screen from any screen, select the RVs button.

Supplies

any screen

Load RVsF4

DoneF1

Load RVs

Remove cartridgecover, load cartridge,remove empty spine

1


2.5: Reaction Vessels (RVs) Access 2 Operator’s Guide

Select Load RVs F4.

The system displays the Load RVs window, moves the rake out of the way, and releases the latch on the RV load door. There may be a delay as the system prepares for loading RVs.

Peel back and remove the protective covering from the RV cartridge.

To be sure that all 98 RVs are firmly seated in the cartridge spine, press down on the spine before you load the cartridge.

Open the supplies door on the front of the instrument (see Figure 2-14).

Open the RV load door.

Insert an RV cartridge into the RV supply area.

0013A.eps

1 Supplies Door

2 RV Load Door

Figure 2-14 Inserting an RV Cartridge into the RV Supply Area

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Access 2 Operator’s Guide 2.5: Reaction Vessels (RVs)

To release the RVs, press down firmly on the RV load door until it snaps closed.

Open the RV load door and remove the empty spine. Do not leave the RV load door open longer than necessary when the system is processing.

CAUTION

Remove the empty cartridge spine to prevent possible damage to the RV rake.

Close the RV load door.

Close the supplies door.

Select Done F1.

The RV rake moves forward to hold the RVs in position and the system updates the Supplies screen with the current RV inventory.

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2.6: Reaction Vessel Waste Bag Access 2 Operator’s Guide

2.6Reaction Vessel Waste Bag

When a test is complete, the instrument ejects the reaction vessel (RV) through the waste chute into the RV waste bag. The RV waste bag holds up to 300 RVs. The system monitors the number of RVs ejected into the waste bag, and warns you when the waste bag is nearing capacity.

When you install a new RV waste bag, the system resets the RV counter.


For more information about how RVs move through the system, see Section 3.1: Sample Processing Theory in the Reference Manual.

When the waste bag has room for 60 or fewer RVs, the RV Waste Bag button (represented by a biohazard symbol) turns yellow. When the RV waste bag is full, the button turns red and the system will not start processing samples. You must change the RV waste bag.

RV Waste Bag Button

0577A.bmp


Access 2 Operator’s Guide 2.6: Reaction Vessel Waste Bag

0507A.wmf

Figure 2-15 Changing the RV Waste Bag Flowchart

Changing the RV Waste Bag

Use this procedure to change the RV waste bag.

WARNINGYou 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.

NOTES

• The system will not start sample processing without a waste bag in place.

• Always use the Change RV Waste Bag window to change the waste bag to be sure the system can properly monitor RV waste bag capacity.

Supplies

any screen

Change RV Waste BagF6

DoneF1

Change RV Waste Bag

Remove and seal oldbag, insert new bag,

and close thesupplies door

Open supplies door,unfold and expand

new bag


2.6: Reaction Vessel Waste Bag Access 2 Operator’s Guide

Go to the Supplies screen. To get to this screen from any screen, select the RV

Waste Bag button.

Select Change RV Waste Bag F6.

The Change RV Waste Bag window is displayed.

Open the supplies door on the front of the instrument.

Unfold a new waste bag, grasp its sides, and pull gently to expand it.

Remove the RV waste bag and seal it.

NOTE

If the instrument is ejecting RVs, wait until you hear an RV ejected. You then have 36 seconds to remove the old waste bag and install the new one before the instrument ejects the next RV.

CAUTION

If the system is in the Running mode when you change the RV waste bag, the system may try to eject an RV when the plastic collar on the waste bag is blocking the ejection chute. This will cause a jam.

Place the new bag into position by sliding the plastic collar on the bag into the slot on the waste chute. Press down firmly to be sure that the collar is completely seated.

NOTE

If the next RV in line sticks out from the ejection chute slightly, it may prevent the plastic collar on the new waste bag from sliding into the slot on the waste chute. Gently push the top of the RV back slightly and out of the way of the plastic collar.

CAUTION

To prevent damaging the system, DO NOT push an RV that is sticking out from the ejection chute all the way back into the chute.

Discard the used biohazardous waste bag.

Close the supplies door.

Select Done F1.

The Supplies screen updates the RV waste capacity.

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Access 2 Operator’s Guide 2.7: Reagent Packs

2.7Reagent Packs

A reagent pack is a container that holds up to five assay-specific reagents. Reagents include:

• Conjugate

• Paramagnetic particles with analyte-specific antigens or antibodies attached

• Stripping agents

• Buffered protein solutions

The instrument holds up to 24 reagent packs.

When an on-board reagent pack fails reagent pack monitoring, the test in process is cancelled and the reagent pack is rejected and cannot be used for further processing. Unload and discard the pack. For more information about reagent pack monitoring, see Section 1.3: Assay Technology in the Reference Manual.

For reagent packs in inventory, the Access 2 system also tracks the lot expiration date and the number of days the pack has been open.

For more information about sample processing and supplies required, in Section 4.1: Sample Processing.


The Access 2 system monitors the number of tests processed using each reagent pack. When an on-board reagent pack does not contain enough reagent to process requested tests, the system assigns those tests the Supplies Required status and the Supplies Required button (represented by a checklist) turns yellow. When you load a new pack onto the instrument, the system takes the requested tests out of Supplies Required status and begins processing them.

Supplies Required Button

0578A.bmp


2.7: Reagent Packs Access 2 Operator’s Guide

0502C.wmf

Figure 2-16 Loading a Reagent Pack Flowchart

Supplies

Main Menu

SuppliesF3

Load Reagent PackF1

Load Reagent Pack Reagent Inventory

Load Reagent PackF1

Reagent InventoryF7

You can also load a reagent pack from the Reagent Inventory screen

You can load a reagent pack from the Supplies Required screen

any screen

Supplies Required

Load Reagent PackF1

DoneF1

Insert reagent pack, scan reagent pack

Or from the Main Menu

Invert unpunctured pack several times



Loading a Reagent Pack

Use this procedure to load a reagent pack onto the instrument.

WARNINGS• You will come in contact with potentially infectious materials during this

procedure. Handle and dispose of biohazard materials according to proper laboratory procedures. Proper hand, eye, and facial protection is required.

• If you are reloading a partially used reagent pack, it must be returned to the same stand-alone system or Access 2 workgroup from which it was removed. If a partially used reagent pack is loaded on a different system or workgroup, it will be inventoried as a full pack and inaccurate results may occur.

NOTES

• If you try to load an empty reagent pack, the system displays a message and prevents you from loading it.

• If you load an expired reagent pack, the system displays a message. You can only use the pack if you override the expired condition. For information about using expired reagent packs, see the Overriding Supply Conditions procedure in Section 4.2: Supply and Calibration Conditions.

Go to the Supplies screen. To get to this screen from the Main Menu, select Supplies F3.

You can also load reagent packs from the Reagent Inventory screen or the Supplies Required screen.

For information about the Reagent Inventory screen, see Section 2.8: Reagent Inventory.

For information about the Supplies Required screen, see Chapter 4: Sample Processing.

Select Load Reagent Pack F1.

The Load Reagent Pack window is displayed.

NOTE

You must always use the Load Reagent Pack window to load a reagent pack to be sure the system can monitor the location of and tests left in the reagent pack.

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0663A.bmp

Figure 2-17 Load Reagent Pack Window

Bar Code (Field) Using either the handheld bar code reader or the keyboard, enter the bar code ID of the reagent pack.

Test Name (Field) Displays the test name of the reagent pack.

If a pack is used for more than one test, the system displays the primary test for that pack. For example, the Folate pack is used to run a primary test (Folate) and a secondary test (RBC Folate). The system displays the primary test (Folate).

Lot Number (Field) Displays the lot number of the reagent pack.

Serial Number (Field) Displays the unique serial number of the reagent pack.

Expiration Date (Field) Displays the expiration date of the reagent pack.

Tests Left (Field) Displays the number of tests that can be run using the reagent pack.

Table 2-18 Load Reagent Pack Window Descriptions



To dislodge particles from the underside of the seal, invert unpunctured pack several times immediately before loading. It is not necessary to remix packs after loading. Do not shake packs or use a vortex mixer. Do not invert a punctured pack.

Slide the carousel door to the left to open it.

Open the reagent carousel door.

Insert the reagent pack into the empty slot directly under the reagent carousel door. Angle the narrow end of the pack down into the slot, pressing forward gently as you lower the pack into position (see Figure 2-19). Press down on the back of the pack until it snaps into place, then gently pull the pack back toward the outer rim of the reagent carousel. A spring on the front of the pack and a small plastic anchor on the back of the pack hold it securely in place.

0764B.eps

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2 1

6

1 Reagent Pack 2 Reagent Carousel Door

3 Spring 4 Empty Slot

5 Angle pack into empty slot 6 Press pack into place

Figure 2-19 Loading a Reagent Pack into the Reagent Carousel



2-36 2014 Beckman Coulter, Inc.

CAUTION

To prevent damaging the reagent pack, be sure it is properly seated in the reagent carousel.

Enter the reagent pack bar code by scanning the reagent pack with the handheld bar code reader or by typing the characters above the reagent pack bar code in the Bar Code field.

The system displays the reagent pack bar code, pack name, lot number, serial number, expiration date, and number of tests that the system can process using the reagent pack in the Load Reagent Pack window.

For an illustration of how to use the bar code wand, see Figure 2-20. For more information on scanning the bar code, including information on how to use other handheld bar code readers, see the Manually Scanning Bar Codes procedure in Section 2.1: Supplies.

0019F.eps

Figure 2-20 Scanning a Reagent Pack Bar Code with the Bar Code Wand

Close the reagent carousel door.

Slide the carousel door to the right to close it.

Select Done F1.

The Supplies screen displays a button for that reagent pack in the list of on-board reagent packs.

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Total IgE

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b

c

d

e

c

WM8T3F6D

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P/N B14251D 9/14



0503A.wmf - v1.7

Figure 2-21 Unloading a Reagent Pack Flowchart

Unloading a Reagent Pack

Use this procedure to unload a reagent pack from the instrument.

NOTES

• If the system is using a reagent pack to process tests, you cannot unload it (identified by the in-use [padlock] icon on the Supplies screen).

• When you unload a partially full reagent pack, the system keeps track of the number of tests left in the pack until you reload it or manually delete it from inventory.

• Immediately unload any reagent packs that are empty or are rejected as a result of reagent pack monitoring.

Supplies

Main Menu

SuppliesF3

Unload Reagent PackF2

DoneF1

Unload Reagent Pack

Remove reagent packfrom reagent carousel

Reagent Inventory

Unload Reagent PackF2

DoneF1

Unload Reagent Pack

Remove reagent packfrom reagent carousel

Reagent InventoryF7

You can also unload areagent pack from theReagent Inventory screen



Go to the Supplies screen. To get to this screen from the Main Menu, select Supplies F3.

Using the touch screen or the mouse, select the button for the reagent pack you want to unload.

NOTE

The Supplies screen does not recognize selections made with the arrow keys on the keyboard. If you use the arrow keys to select a reagent pack, a different reagent pack may be displayed in the Unload Reagent Pack window and presented for unloading.

Select Unload Reagent Pack F2. The Unload Reagent Pack window displays the pack information for the reagent pack you selected.

NOTE

Even if the reagent pack you want to unload is already in the unloading position in the reagent carousel, you must use the Unload Reagent Pack window to unload the pack to be sure the system can properly monitor the reagent inventory.

Slide the carousel door to the left to open it.

Open the reagent carousel door.

Remove the reagent pack from the slot directly under the reagent carousel door. Press forward gently as you lift the back end of the reagent pack. Slide the pack back slightly to release the spring on the front before completely removing it from the carousel.

Close the reagent carousel door.

Slide the carousel door to the right to close it.

Select Done F1.

The system removes the pack from the Supplies screen but keeps the pack information in the database.

If the unloaded reagent pack is empty or was rejected as a result of reagent pack monitoring, discard it as biohazardous waste.

The system automatically deletes the pack from the database.

If you intend to use the unloaded pack again, store it upright in the refrigerator. Use the pack before it expires.

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Retrieving Misplaced Packs

For the Access 2 system to accurately track the proper locations of reagent packs on the reagent carousel, the packs must be loaded and unloaded using the appropriate system windows. If you load a pack and do not use the Load Reagent Pack window, or if you use the Unload Reagent Pack window, but do not remove the pack, you will have a misplaced pack on your system.

Use this procedure to retrieve a misplaced reagent pack.


Be sure the system is in the Ready or Not Ready mode, and then unload all reagent packs from the reagent carousel. For more information, see the Unloading a Reagent Pack procedure.

Go to the Mechanics screen. To get to this screen from the Main Menu, select Diagnostics F7 to display the Diagnostics menu, then

Select Device Diagnostics F4 to display the Device Diagnostics screen, then

Select Mechanics F1.

Select Disable Motors F8.

Slide the carousel door to the left to open it, and then open the reagent carousel door.

Gently turn the reagent carousel one rotation. If you find any reagent packs remaining on the carousel, remove them as they come into position at the reagent carousel door.

After verifying that all packs are removed, close the reagent carousel door and then slide the carousel door to the right to close it.

Select Enable Motors F8.

Home the reagent carousel. For more information, see the Homing a Device procedure in Section 5.5: Mechanics and Device Diagnostics of the Reference

Manual.

When homing is complete, initialize the system. For more information, see the Initializing the System procedure in Section 5.2: Initialize System of the Reference Manual.

When system initialization is complete, reload all of the packs you removed from the reagent carousel. For more information, see the Loading a Reagent Pack procedure.

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2.8: Reagent Inventory Access 2 Operator’s Guide

2.8Reagent Inventory

The Access 2 system keeps an inventory of all on-board and off-board reagent packs for every instrument in the workgroup. When you load a reagent pack, you scan a bar code label on the pack. The bar code label contains the following information:

• Pack name

• Lot number

• Serial number

• Lot expiration date

The system also tracks the following non-bar coded information for each pack:

• Tests left

• Number of days the pack has been open (and the open pack expiration date)

• Pack expiration date (the earlier of two dates: the lot expiration date printed on the label and the open pack expiration date)

• Calibration expiration date (for assays that are calibrated)

• Slot number (for packs on board the instrument the PC is attached to)

• Instrument the pack is on (for packs on board an instrument in the workgroup)

You can remove a reagent pack from the instrument, store it, and reload it when needed.

To maintain the reagent pack inventory, the system automatically deletes empty packs when you unload them. You can manually delete full or partially full packs, if necessary.

NOTE

You cannot reload a reagent pack after you have deleted it.

For more information about how to delete reagent packs, see the Deleting a Reagent Pack procedure in this section.


Access 2 Operator’s Guide 2.8: Reagent Inventory

For information on scanning the bar code, see the Manually Scanning Bar Codes procedure in Section 2.1: Supplies.

For information about how to load and unload reagent packs, see Section 2.7: Reagent Packs.

For detailed information about open pack stability and expiration, see the reagent instructions for use in the Assay Manual.




Reagent Inventory ScreenYou use the Reagent Inventory screen to:

• View the reagent packs inventory


• Track open reagent packs

• Delete reagent packs from inventory

• Print the Reagent Inventory Report

• Apply a filter for viewing or printing the reagent pack inventory

To get to this screen from the Main Menu, select Supplies F3 to display the Supplies screen, then select Reagent Inventory F7.

OR

Select the Substrate, RVs, or RV Waste Bag button from any screen to display the Supplies screen, then select Reagent Inventory F7.

0587C.bmp

Figure 2-22 Reagent Inventory Screen



Filter (Field) Displays the filter and sort order applied.

The default filter is all packs on the instrument the PC is attached to, sorted by test name.

Open Slots (Field) Displays the number of empty reagent pack positions on the reagent carousel.

The number of open slots only applies to the instrument the PC is attached to.

Entries (Field) Displays the number of reagent packs that meet the current filter parameters.

Test Name (Column) Displays the test names. The entry in this column turns red when the reagent pack is rejected as a result of reagent pack monitoring.

The system updates the screen continuously as you load and unload reagent packs. Each pack is identified by a unique serial number.

If a pack is used for more than one test, the system displays the primary and secondary tests for that pack. For example, the Folate pack is used to run a primary test (Folate) and a secondary test (RBC Folate). The system displays both of the tests, primary and secondary, under the primary test (Folate). When sorted, the primary and secondary tests stay together.

Lot No. (Column) Displays the reagent pack lot numbers.

You can load multiple reagent packs with the same lot number on the instrument at one time.

Serial No. (Column) Displays the unique reagent pack serial numbers.

The system uses this number to track inventory information for the reagent pack.

Tests Left (Column) Displays the number of tests the system can process using each reagent pack. The field in this column turns yellow when there are 10 tests or fewer remaining for all on-board packs with the same lot number, or if the open pack expiration date is within three days. The field in this column turns red when there are zero tests left, or the pack is past the open pack expiration date.

NOTE

To refresh the information displayed in this column, you must exit the screen and redisplay it.

Days Open (Column) Displays the number of days since the system first punctured the reagent packs.

Table 2-23 Reagent Inventory Screen Descriptions



Pack Expiration (Column) Displays the dates the reagent packs expire.

The pack expiration date is the lot expiration date or the open pack expiration date, whichever is earliest.

For a specific reagent pack, the entry in this column turns yellow when the reagent pack expires within three days. The entry turns red when the reagent pack is expired.

To calculate the open pack expiration, the system records the date the primary probe first punctures the reagent pack and adds a number of days past that date, based on limits specified in the assay protocol file (APF).

Calib. Expiration (Column) Displays the expiration dates of the current assay calibrations.

• For on-board packs with more than one calibration, the expiration date of the active calibration is displayed.

• For on-board packs with no established calibration, the value None is displayed.

• For off-board packs, the value Unloaded is displayed.

For a specific reagent pack, the entry in this column turns yellow when the calibration expires within three days. The entry turns red when the calibration is expired.

Assay calibrations can be completed while you are reviewing this screen. To refresh the information displayed in this column, exit the screen and redisplay it.

For more information about calibrations, see Chapter 6: Assay Calibrations.

Slot (Column) Displays the position of reagent packs on the reagent carousel. Slot positions are from 1 to 24.

If the pack is off board, the entry is blank.

Instrument (Column) Displays the instrument the reagent pack is loaded on.

If the pack is off board, the entry is blank.


(Button) Select to load a reagent pack. When the instrument presents an empty pack position on the reagent carousel, you can load a reagent pack.

For more information on loading a reagent pack, see the Loading a Reagent Pack procedure in Section 2.7: Reagent Packs.

Table 2-23 Reagent Inventory Screen Descriptions (continued)



Applying a Filter to the Reagent Inventory Screen

A filter is a set of parameters you can change to increase or decrease the number of reagent packs that display on the Reagent Inventory screen. A filter is always applied. The default filter at system installation is all packs sorted by pack name on the instrument the PC is attached to. Use this procedure to apply a different filter to the Reagent Inventory screen.

NOTE

The system uses the selected filter until you apply a different one.

Go to the Filter window. To get to this window from any screen:

Select the Substrate, RVs, or RV Waste Bag button to display the Supplies screen, then

Select Reagent Inventory F7 to display the Reagent Inventory screen, then

Select Filter F8.

Unload Reagent Pack F2

(Button) Select to unload the selected reagent pack. When the instrument presents the reagent pack, you can unload it from the reagent carousel.

For more information on unloading a reagent pack, see the Unloading a Reagent Pack procedure in Section 2.7: Reagent Packs.

This button is unavailable if the selected pack is already off board, or if it is on board another instrument in the workgroup.

Delete Pack F5 (Button) Select to delete an off-board reagent pack from inventory. When you delete a reagent pack, the system removes pack information from screens and reports, but keeps it in the database. You can delete full or partially full off-board reagent packs.

NOTE

You cannot reload a reagent pack after you have deleted it.

This button is unavailable if the selected pack is on board an instrument.

Print F7 (Button) Select to print the Reagent Inventory Report for all reagent packs in the current filter.

Filter F8 (Button) Select to choose filter parameters, sort order, and instruments to include on the Reagent Inventory screen. The filter and sort order you select displays in the Filter field.

Table 2-23 Reagent Inventory Screen Descriptions (continued)

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0664B, rev 1.1.bmp

Figure 2-24 Filter (Reagent Inventory) Window

Filter (List) Select a filter that limits the packs that display on the Reagent Inventory screen.

Instruments (List) Displays the instruments in the workgroup. Select one or more workgroup instruments to display the packs on the selected instruments only.

NOTE

This field is disabled when you select Off-Board

Packs in the Filter field.

Sort Order (Options) Select to change the default sort order of the packs.

Values are: Pack Name, Tests Left, Days Open, Pack

Expiration, Carousel Slot, and Instrument.

Table 2-25 Filter (Reagent Inventory) Window Descriptions



Select a filter criteria.

Select a sort order option.

NOTE

If you select the All Packs filter, the Carousel Slot option is not available.

Select one or more instruments in the workgroup.

Select or clear the Ascending option.

Select OK F1.

The Reagent Inventory screen displays the reagent packs according to the filter criteria, sort order, and instruments you selected.

Ascending (Box) Displays the default sort order of the packs. Select to sort the packs in the ascending order and clear to sort in descending order.

The system sorts the packs in the following order:

• Pack Name and Instrument are sorted alphanumerically

• Tests Left, Days Open, and Carousel Slot are sorted numerically

• Pack Expiration is sorted by date

Table 2-25 Filter (Reagent Inventory) Window Descriptions (continued)

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0508A.wmf

Figure 2-26 Deleting a Reagent Pack Flowchart

Deleting a Reagent Pack

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

NOTES

• You cannot reload a reagent pack after you have deleted it.

• You cannot unload or delete a reagent pack that is in use.

• You must unload a reagent pack before you can delete it.

• The system automatically deletes an empty reagent pack from inventory when you unload it from the instrument.

Supplies

Main Menu

SuppliesF3

Reagent InventoryF7

Reagent Inventory

Select the reagent packyou want to delete

Reagent packoff board?

Yes

No

Delete PackF5

Unload thereagent pack

For more detailed information aboutunloading a reagent pack, see theUnloading a Reagent Packprocedure in this chapter.



Go to the Reagent Inventory screen. To get to this screen from any screen, select the Substrate, RVs, or RV Waste Bag button to display the Supplies screen, then select Reagent Inventory F7.

(Optional) To easily locate the pack you want to delete, apply a filter to reduce the number of packs displayed. For help on how to do this, see the Applying a Filter to the Reagent Inventory Screen procedure in this section.

Select the off-board reagent pack you want to delete.

Check to see if the reagent pack you selected is off board by verifying that the slot and instrument fields are blank for this reagent pack.

(Optional) If the reagent pack is on board an instrument, find and unload the reagent pack. For help on how to do this, see the Unloading a Reagent Pack procedure in Section 2.7: Reagent Packs.

Select Delete Pack F5.

The system displays a window.

Select Yes F1.

The system deletes the reagent pack.

Printing the Reagent Inventory Report

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

Go to the Reagent Inventory screen. To get to this screen from any screen, select the Substrate, RVs, or RV Waste Bag button to display the Supplies screen, then select Reagent Inventory F7.

(Optional) To print the Reagent Inventory Report for one or more selected packs, select the packs you want to print. If you do not select any packs, the system prints the report for all packs displayed on the Reagent Inventory screen.

Select Print F7.

The system prints the Reagent Inventory Report (see Figure 2-27).

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0746C.bmp

Figure 2-27 Reagent Inventory Report

Filter: All Packs -- Sorted by Test Name

Page 1 of 1Technologist______________________________ Printed 04/04/06 02:43 PM

Reagent Inventory ReportAccess 2 Immunoassay System

Laboratories, Inc.Laboratory A

123 Lake StreetTownsville, ST 33333101-555-2323 ext. 109

Jane Smith

Test Name Lot No. Serial No. TestsLeft

DaysOpen

Pack Expiration

Calib. Expiration

Slot Instrument

PSA-Hyb 066851 3461 50 0 06/30/06 04/08/06 4 500135

PSA-Hyb 006851 3454 8 20 04/12/06 04/08/06 1 500135

PSA-Hyb 006851 2298 2 35 03/28/06 Unloaded

PSA-Hyb 006851 3010 7 38 03/25/06 Unloaded

MYO 093738 14283 47 7 04/25/06 04/05/06 8 501240

FOL2 085673 232 5 12 04/06/06 3 501240

FOL2 04/20/06

RBC2 None

Ferritin 105011 1259 17 5 04/27/06 04/20/06 6 501240

Ferritin 125002 3374 27 4 04/28/06 Unloaded

Ferritin 125002 1121 38 3 04/29/06 Unloaded

CK-MB 013055 956 50 0 01/31/07 None 15 501240

CK-MB 013055 842 50 0 01/31/07 None 14 501240

CK-MB 013040 1010 10 12 04/20/06 04/05/06 9 501240

aTnI 623123 11863 50 0 01/31/07 04/05/06 7 501240

aTnI 623123 8715 47 7 04/25/06 04/05/06 2 501240

aTnI 623123 4168 0 12 04/20/06 04/05/06 10 501240

aTnI 623123 1122 0 18 04/14/06 04/05/06 17 501240


Access 2 Operator’s Guide 3: Sample Management

3Sample Management

3.1 Sample Management...................................................................................3-3

Sample Manager Screen....................................................................................3-5

Placing Sample Containers in Racks ................................................................3-9

Loading Racks................................................................................................. 3-10

Unloading Racks ............................................................................................. 3-12

Resolving Sample Errors ................................................................................ 3-14

Changing Rack IDs ......................................................................................... 3-15

Clearing Racks ................................................................................................ 3-15

Entering Sample Comments............................................................................ 3-16

Changing the Reagent Lot for Running Calibrations or Controls .................. 3-16

Requesting Service Assays ............................................................................. 3-17

3.2 Patient Test Requests................................................................................... 3-19

Test Requests Screen ......................................................................................3-20

Navigating the Test Requests Screen.............................................................. 3-26

Processing LIS Patient Test Requests ............................................................. 3-27

Entering Patient Test Requests Manually .......................................................3-31

Using Auto Sample ID.................................................................................... 3-35

Using Batch Request ....................................................................................... 3-37

Reusing Sample IDs........................................................................................ 3-37


3: Sample Management Access 2 Operator’s Guide

3.3 Calibration Test Requests ........................................................................... 3-38

Entering Calibration Test Requests................................................................. 3-40

3.4 Quality Control Test Requests.................................................................... 3-43

Entering Quality Control Test Requests ......................................................... 3-45

3.5 Working with On-Board Samples.............................................................. 3-48

Adding, Removing, and Rearranging On-Board Samples .............................. 3-49

Editing Test Requests for On-Board Samples ................................................ 3-52

Deleting Test Requests for On-Board Samples .............................................. 3-54

Adding Test Requests to On-Board Samples Using the Pause Button ........... 3-56

Deleting Test Requests from On-Board Samples Using the Pause Button..... 3-58


Access 2 Operator’s Guide 3.1: Sample Management

3.1Sample Management

Sample management is the process of placing patient, maintenance, quality controls, or calibration samples in racks, entering test requests, and loading the racks onto the Access 2 instrument for processing.

A test request includes a unique sample ID, information about the sample such as patient ID and priority, and the tests you want to run on that sample.

You load samples onto the instrument in racks. Each rack is identified by a unique bar-coded rack ID. When you load a rack onto the instrument, the system uses the rack ID to identify the type of sample containers. In addition, the system displays real-time summary information for each defined rack including:

• Location of the rack (on or off board the instrument)

• Estimated time until the instrument completes aspirating all samples in the rack

• Estimated time until the instrument completes processing all samples in the rack

• Sample container positions in the rack

• Any sample management errors, such as an illegible bar code or no test requests for a sample on board the instrument

You can set up patient samples with or without a Laboratory Information System (LIS). If you are using an LIS, the system downloads test request information automatically after you load the rack. You cannot use an LIS to set up calibration, quality control, or maintenance samples.

For an overview of Sample Management, see Figure 3-1.

For information about how to process samples, see Chapter 4: Sample Processing.


3.1: Sample Management Access 2 Operator’s Guide

0619D.wmf

Figure 3-1 Sample Management Flowchart

Main Menu

Sample ManagerF1

Place samples on racks

All racks loaded?

Are sample IDs

read by internal bar code reader?

Load rack and select Done F1

Load a RackF1

No

Yes

Sample Manager

Test RequestF3

Test Requests

Enter sample IDs

Load Rack [X]F1

Yes

No


All racks loaded?

Yes

Using LIS?

Using LIS?

Yes

Test RequestF3

Test Requests

Enter test requests

No

Yes

Run

Run

Enter a rack ID

No

No



Sample Manager ScreenYou use the Sample Manager screen to:

• View summary information for defined racks and the samples in them

• Define racks in the system, and load and unload them

• Add samples to or remove them from racks

• Display the Test Requests screen and enter test requests

• Request maintenance routines

• Display the Work Pending screen

• Delete racks and their associated samples from the system

• Change rack IDs

To get to this screen from the Main Menu, select Sample Manager F1.

0586C.bmp

Figure 3-2 Sample Manager Screen



On Board (List) Displays a rack button for each rack that is on board the instrument. You can load up to six racks. Displays the most recently loaded rack button at the top. When you unload the rack, the system moves the rack button to the Off Board list.

Off Board (List) Displays a rack button for each rack that is defined for the instrument, but is currently off board. Displays the most recently unloaded rack button at the top. When you load the rack, the system moves the rack button to the On Board list.

Rack Button (Button) Displays information for each rack. Each of the rack buttons contains the following data:

• Rack ID number

• Number and position of the samples on the rack (graphically displayed using an image of a rack with blue sample tubes)

• Rack status

• Aspiration and completion time for the rack

• Any bar code errors or QNS errors

Possible rack status values are: No Tests, Requested, Supply Wait, In Progress, Aspirated, Done, and *Done*.

The rack status is determined by the status of the least progressed, individual samples. For example, if 9 samples have been aspirated, but one has not been aspirated, the rack status is In Progress. Once the final sample has been aspirated, the status changes to Aspirated.

For more information about rack statuses, see Chapter 4: Sample Processing.

You must select a rack button before you can do anything with it. You can select a rack in the following ways:

• Touching the screen or using the mouse to select the rack you want

• Using the 4 directional arrow keys

• Typing the rack button ID in the Rack ID field and pressing the [Enter] key

Table 3-3 Sample Manager Screen Descriptions



Rack Icon (Indicator) Displays the position of each sample container in the rack. Indicates any sample errors that occur after you load the rack. If any of the following errors occur, the system displays a red sample container in the corresponding position of the rack icon:

• The internal bar code reader could not read the bar code on the sample container.

• There is no sample container in a position you entered a test request for.

• There are two or more loaded samples with the same sample ID on the same instrument.

After you select Run, and if there is not enough sample to complete the ordered tests, the system displays a red sample container in the corresponding position of the rack icon and associates a QNS flag to the result.

Rack ID (Indicator) Displays the rack ID of the selected rack.

To define a new rack in the system, enter the rack ID or load the rack and wait for the internal bar code reader to scan the rack ID label.

NOTES

• Rack IDs are shared across the Access 2 system. Each rack ID must be unique across all instruments in a workgroup.

• To define a maintenance rack, you must enter the rack ID. If you load the rack and wait for the internal bar code reader to scan the rack ID, the rack is designated for sample processing and cannot be used for maintenance.

Asp. (Field) Displays the rack aspiration status.

When the rack status is In Progress, displays the estimated time until the instrument finishes aspirating all tests for all samples in the rack.

When the rack status is Aspirated, displays Done. You can then get or unload the rack.

When the rack status is No Tests, Requested, Supply Wait, Done, or *Done*, the system displays the status instead of the Asp. and Comp. fields.

Comp. (Field) Displays the rack completion time.

When the rack status is In Progress or Aspirated, displays the estimated time until the instrument completes all tests selected for all samples in the rack.

When the rack status is No Tests, Requested, Supply Wait, Done, or *Done*, the system displays the status instead of the Asp. and Comp. fields.

Table 3-3 Sample Manager Screen Descriptions (continued)



Load a Rack F1 (Button) Select to load a rack onto the instrument.

When the instrument presents an empty rack position on the sample carousel, you can load the rack.

Work Pending F2 (Button) Select to display the Work Pending screen. You use this screen to view:

• Reflex tests for samples not on board any instrument in a workgroup

• LIS test requests for samples not on board any instrument in a workgroup

• Re-ordered tests from Test Results (Rerun test)

For more information about this screen, see Chapter 4: Sample Processing.

Test Request F3 (Button) Select to display the Test Requests screen. You use this screen to:

• Enter test requests for patient samples if you are not using an LIS

• Enter test requests for calibration and quality control samples

• Edit or delete test requests

• Monitor processing of specific samples

Maintenance Request F4

(Button) Select to display the Request Maintenance window. You use this window to request one or a combination of the following maintenance routines:

• Daily Clean System

• Special Clean

• System Check

For more information about maintenance requests, see Chapter 8: Routine Maintenance in the Operator’s Guide.

Get Selected Rack F6

(Button) After you select a rack from the On Board list, select to get the rack from the instrument. The system displays the Get Selected Rack window and presents the selected rack. You can then add, remove, or rearrange samples or unload the rack from the instrument.

NOTE

This button is only displayed when you select a rack from the On Board list.




Placing Sample Containers in Racks

Place all samples to be tested on the Access 2 system in racks before loading them onto the instrument. The rack ID on each rack identifies what type of sample containers you may use in that rack. Each rack holds up to ten sample containers. Place all sample containers except insert cups directly in the rack. Place insert cups into another sample container appropriate for the rack you are using.



• Air bubbles in samples can affect level sensing by the Access 2 system and compromise the integrity of test results. Avoid creating bubbles when transferring samples to a secondary container. Always inspect samples before loading on the instrument, and remove or break any bubbles.

• To minimize sample evaporation, be sure the sample is pipetted into the RVs within one hour of loading it onto the instrument. Be sure sample from 3 mL sample containers is pipetted into the RVs within two hours of loading.

Clear Selected Rack F7

(Button) After you select a rack from the Off Board list, select to delete all information for the rack from the system. Clearing a rack removes the rack button from the Sample Manager screen and any associated sample information from all other screens, but does not delete the sample information from the database.

• You must clear a rack before you can reuse it.

• You cannot clear a rack from the On Board list.

The system prompts you to clear the rack when you unload a rack with a status of Done or *Done*.

The system automatically clears racks with no test requests when you unload them.

NOTE

This button is only displayed when you select a rack from the Off Board list.

Change Rack ID F8 (Button) After you select a rack from the Off Board list, select Change Rack ID F8 to edit the rack ID.

NOTE

This button is only displayed when you select a rack from the Off Board list.




• Use only recommended sample containers and place them in a rack with a rack ID defined for that type of sample container. Using containers other than those specified for use with a particular rack ID may damage the system and compromise the integrity of test results.

• Remove caps from all sample containers before loading on the Access 2 system.

Place sample containers in racks according to the following guidelines:

• Fill sample containers with enough sample for the test to be run. To calculate the sample volume, see Section A.2: Sample Containers.

• If you have less than 1 mL of sample, carefully pipette the sample into a sample cup or insert cup.

• If you are using the internal bar code reader to scan sample ID bar code labels, be sure the labels are in good condition, are properly affixed to the container, and when placed in the rack, are visible through the slots.

• If you use the internal bar code reader to scan sample ID bar code labels, be sure you use supported sample bar code symbologies and that you configure the internal bar code reader appropriately.

• If you do not want to use the internal bar code reader to scan sample ID bar code labels, disable it when you configure the internal bar code reader.

For more information about appropriate sample containers, corresponding rack IDs, calculating sufficient sample volumes, and using insert cups, see Appendix A: Racks and Sample Containers.

For information about supported bar code symbologies, see Chapter 2: System Specifications in the Reference Manual. For information about enabling, disabling, and configuring the internal bar code reader, see Chapter 4: System Configuration in the Reference Manual.

Loading Racks

Use this procedure to load an off-board rack onto the instrument.


NOTES

• Be sure the rack ID bar code label is in good condition and is properly affixed to the rack. For more information about properly applying rack ID



bar code labels, see Section A.1: Racks.

• You cannot load two racks with the same rack ID bar code label onto an instrument.

• Within a workgroup, each instrument must use racks with unique ID bar code labels. The same rack ID cannot be used on more than one instrument in the workgroup.

Go to the Sample Manager screen. To get to this screen from the Main Menu, select Sample Manager F1.

(Optional) To load a maintenance rack, go to the Maintenance Request screen. To get to this screen from the Sample Manager screen, type the rack ID and select [Enter], then select Maintenance Request F4.

Select Load a Rack F1.

If the system is processing samples, it enters the Paused mode.

The instrument presents a rack position in the sample carousel.

Open the sample carousel door, then pick up the rack by the handle and lower it onto the sample carousel (see Figure 3-4).

Be sure the rack is within the guides of the carousel, and allow the lip of the rack to guide it into position. The peg below the rack handle (under the lip) should rest in the notch on the sample carousel.

0011D.eps

Select Done F1.

1 Rack Peg and Carousel Notch

Figure 3-4 Loading Racks

1

2

3

1

4



The rack and samples are scanned.

(Optional) To load another rack, repeat step 2 through step 4.

Close the sample carousel door.

If there are no errors, select Run.

If there are errors, you need to address them before proceeding to run the samples. For more information about possible errors that can occur and how to resolve them, see Resolving Sample Errors in this section.

Unloading Racks

Use this procedure to unload an on-board rack.



In the On Board list, select the rack you want to unload.

Select Get Selected Rack F6.


5

6

If the rack status is...

The system...

No Tests Presents the rack and displays the Get Selected Rack window with a status message. Follow the instructions on the window.

To stop unloading the rack, select Cancel F8. Otherwise, continue with step 4.

Requested orSupply Wait

Presents the rack and displays the Get Selected Rack window with a status message.


Table 3-5 Rack Status

1

2

3



Open the sample carousel door, then unload the rack by holding onto the rack handle and lifting upward.

Select Done F1.

The system scans the sample carousel for any changes and moves any unloaded rack buttons from the On Board list to the Off Board list on the Sample Manager screen.

The system reports aspirated sample progress on the rack button in the Off

Board list and on the Test Requests screen.

NOTE

You can view the maintenance sample progress from the Maintenance Requests screen. For more information about maintenance samples, see Section 8.1: Routine Maintenance.

In Progress Displays the time remaining until it can present the rack. You must wait to unload the rack. When it can, the system displays the Get Selected Rack window with a status message.

If you unload the rack, the system changes the status of any scheduled tests to Requested and continues to process any aspirated tests.


Aspirated Presents the rack and displays the Get Selected Rack window with a warning message.


The system continues to process the aspirated tests.

Done or *Done* Presents the rack and displays the Get Selected Rack window with an instructional message.

The system scans the sample carousel, then displays a prompt message.

To clear the rack, select Yes F1.

Continue with step 4.

If the rack status is...

The system...

Table 3-5 Rack Status (continued)

4

5



(Optional) To unload another rack, repeat step 2 through step 5.


To continue sample processing, select Run.

For more information about Sample Processing, see Chapter 4: Sample Processing.

Resolving Sample Errors

If a sample error occurs after you load a rack, the system turns the affected sample container red in the rack icon on the Sample Manager and Test Requests screens, and displays a specific error message or indicator in the corresponding Status field on the Test Requests screen.

Use this procedure to resolve any sample management errors that occur after you load a rack.


In the On Board list, look for red sample containers in the rack icon and select a rack icon with a sample error.

Select Test Request F3 to display the Test Requests screen.

Look for error messages in the Status field of the sample in error.

Take the necessary action to resolve the sample error. For more information, see Appendix A: Troubleshooting in the Reference Manual.


If you resolved the error, the system clears the error indicators.

If the rack you unloaded... The system...

Has no test requests associated with it

Automatically clears the rack.

Has reflex tests associated with it Displays them on the Work Pending screen. For information about the Work Pending screen, see Chapter 4: Sample Processing.

6

7

1

2

3

4

5

6



Changing Rack IDs

Use this procedure to change the rack ID of an off-board rack.

NOTES

• You cannot change the rack ID of an on-board rack. If you need to change the rack ID of an on-board rack, you must first unload it.

• You cannot change to a rack ID already assigned to another rack in the On

Board or Off Board lists.


In the Off Board list, select the rack you want to change.

Select Change Rack ID F8.

The Change Rack ID window is displayed.

Enter the correct rack ID.

NOTE

A manually entered rack ID will override a scanned ID. As you type rack IDs, be sure the numbers you enter into the appropriate field are correct.

Select OK F1.

A confirmation window is displayed.

Select OK F1 to change the rack ID.

The system changes the rack ID on the rack button.

Clearing Racks

Use this procedure to clear a rack button from the Off Board list on the Sample Manager screen and all of the associated sample information from the Test Requests or Maintenance Requests screen.

NOTES

• You must clear a rack before you can reuse it.

• You cannot clear an on-board rack.

• The system prompts you to clear the rack when you unload a rack that is Done or *Done*.

• The system automatically clears racks with no test requests when you unload them.

• Clearing a rack does not delete sample information, test results, or the rack

1

2

3

4

5

6



ID associated with the test results from the database.


In the Off Board list, select the rack you want to clear.

Select Clear Selected Rack F7.

The system deletes the rack from the Off Board list and clears all sample information for the rack from the Test Requests or Maintenance Requests screen.

Entering Sample Comments

Use this procedure to enter, edit, or delete comments for patient or quality control samples on the Test Requests screen.

Select the Pen or Notepad button to display the Sample Comment window.

In the Comment field, enter or edit comments. Or, to delete an existing comment, select it and press [Backspace].

To save comments, select OK F1.

Changing the Reagent Lot for Running Calibrations or Controls

Use this procedure to change or set a reagent lot number for a calibration or quality control test request from the Test Requests screen. You can only change or set a reagent lot number when the reagent lot is in inventory and the sample status is Requested. To add a lot to the reagent pack inventory, load the reagent pack. For more information about loading reagent packs, see Section 2.7: Reagent Packs.

Changing Reagent Lots for Calibration Requests

When you enter a calibration request, the system assigns a reagent lot number from a previously calibrated lot. Use this procedure to change that lot number to another available lot. Change the reagent lot number whenever you calibrate a lot for the first time. For more information about entering calibration requests, see Section 3.3: Calibration Test Requests.

1

2

3

The pen indicates no comments are associated with the sample.

The notepad indicates comments are associated with the sample.

1

2

3



On the Test Request screen for a calibration request, the calibrator set is selected by default. Confirm that the Test menu is displayed.

• If the Test menu is not displayed, select Show Test Menu F3.

On the Test menu, select Change Reag. Lot to display the Set Reagent Lot window.

Select the new lot number from the Reagent Lot list and select OK F1.

The system changes the reagent lot number for all of the calibrators in the set and returns you to the Test Requests screen.

Setting Reagent Lots for Quality Control Tests

When you enter a quality control request, no reagent lot number is assigned. When the test is run, the system uses the oldest reagent pack on board which has sufficient reagent, is calibrated, and is not expired. Use this procedure to set a specific reagent lot number. For more information about entering quality control requests, see Section 3.4: Quality Control Test Requests.

From the Test Requests screen, select the quality control for which you want to set a reagent lot.

Confirm that the Test menu is displayed.

• If the Test menu is not displayed, select Show Test Menu F3.

On the Test Menu, select the test from the Tests Requested for Sample X list, then select Change Reag. Lot to display the Set Reagent Lot window.

Select the new lot number from the Reagent Lot list and select OK F1.

The system changes the reagent lot number and returns you to the Test Requests screen.

NOTE

If a reagent lot is set and you want to let the system set the lot, select Any.

The reagent lot for the selected test is set. To set the lot for another test or quality control, repeat this procedure.

Requesting Service Assays

Technical Support representatives use service assays for instrument diagnostics.

NOTE

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

1

2

3

1

2

3

4

5


Access 2 Operator’s Guide 3.2: Patient Test Requests

3.2Patient Test Requests

Before you can request a test for any sample, you must configure the test in the system. When configuring tests, you can modify system default values, such as the test ID, sample type, and reflex test conditions. For each patient test request, you must enter a unique sample ID per instrument and a list of tests to run. For all tests, the system supplies default values, including priority (routine) and dilution factor (1). You can edit any of these fields and also enter sample comments.

If you use an LIS to download patient test and sample information, you load the rack to begin test requests. The system automatically scans the rack ID and sample IDs, and downloads test request information. You can verify or modify the information, and then start processing. If you are using a bar-coded sample container, the system scans the sample ID and any other bar-coded information and enters the information in the appropriate fields and positions.

If you do not use an LIS or bar-coded sample containers, you select or enter test request information manually before processing.

To simplify entering test requests manually, you can use the Auto Sample ID option to automatically assign sequential sample IDs and use the Batch Request option to automatically request the same tests for each sample.

For information about how to configure tests, see Chapter 4: Sample Processing in the Reference Manual.

For more information about how to edit or delete patient test requests, see Section 3.5: Working with On-Board Samples.

Some assays require temperature restrictions. See Appendix A of the Access 2 Instructions for Use manual for information on these restrictions.

For information about how to review patient test results, see Chapter 5: Test Results.

2015 Beckman Coulter, Inc. 3-19P/N B14251E 2/15

3.2: Patient Test Requests Access 2 Operator’s Guide

Test Requests ScreenYou use the Test Requests screen to:

• Enter test requests for patient samples if you are not using an LIS

• Enter test requests for quality control and calibration samples

• Verify test requests downloaded from an LIS for loaded samples

• Edit or delete test requests

• Monitor sample processing

To get to this screen from the Main Menu, select Sample Manager F1, then select Test Request F3.

0583D.bmp

Figure 3-6 Test Requests Screen

SelectedTests

Rack Location Rack StatusRack ID Rack Icon

Position

SelectedSample

Rack Location (Field) Displays the location of the rack.

Values are: Unloaded, Loaded, and Scanned/Loaded.

Table 3-7 Test Requests Screen Descriptions



Rack ID (Field - Rack ID) Displays the ID of the rack selected on the Sample Manager screen. If you want to change the selected rack, you must go back to the Sample Manager screen, select a different rack, then select Test Request F3.

Rack Icon (Indicator - Rack Icon) Displays the rack ID and position of each sample container in the rack.

If any of the following sample management errors occur after loading, the system turns the affected sample container red:

• The internal bar code scanner could not read the bar code on the sample container

• A sample container is missing or is not in the correct position (for manual requests only)

• There is not enough sample to complete one or more tests

For more information about resolving sample management errors, see Section A.4: Assay Troubleshooting in the Reference Manual.

Rack Status (Field) Displays the sample processing status for the rack as determined by the least processed sample in the rack.

Values are: No Tests, Requested, Supply Wait, In Progress, Aspirated, Done, or *Done*.

For more information about rack statuses, see Section 4.4: Monitoring Sample Progress.

Batch Request (Indicator) Displays the text "Batch Request" to the left of the rack location when you turn Batch Request on. When turned off, this indicator is not shown.

For more information about Batch Request, see the Using Batch Request procedure in this section.

Auto Sample ID (Indicator) Displays the text "Auto Sample ID" to the right of the rack status when you turn Auto Sample ID on. When turned off, this indicator is not shown.

For more information about Auto Sample ID, see the Using Auto Sample ID procedure in this section.

Position (Button) Select to enter information about the sample in rows numbered 1-10. The rows correspond to the ten positions in the selected rack, from left to right with the convex side of the rack facing you.

The fields in each sample position row pertain to the sample in that position on the rack.

Table 3-7 Test Requests Screen Descriptions (continued)



Sample ID (Field) For patient samples, enter a unique sample ID. Sample IDs are unique for loaded samples on the same instrument.

NOTES

• You can use a maximum of 15 characters, numbers 0 through 9, uppercase and lowercase letters A through Z, asterisk (*), slash (/), plus (+), and minus (-).

• Spaces, punctuation marks, and special characters are not accepted.

For quality control samples, select Request QC F5 to select the quality control name. For calibration samples, select Request Calibration F6 to select the calibrator set name.

If you are using bar-coded sample containers, the system scans the sample ID and any other bar-coded information and enters the information in the appropriate fields and positions after you load the rack.

Patient ID/Lot Number

(Field) For patient samples, enter an optional patient ID (1-15 alphanumeric characters). If you enter a quotation mark ("), characters to the right of the quotation mark may not print on reports.

NOTES

• A patient ID is required for LIS test requests.

• For the Simplified Chinese language, the 15 character limit is determined by the combined length of the Simplified Chinese and alphanumeric characters you enter in this field. The system counts a Simplified Chinese character as two characters, and an alphanumeric character as one character.

For quality control or calibration samples, you can select one of the available lots from the list.

For more information about QC setup, see Chapter 7: Quality Controls.

For more information about calibration setup, see Chapter 6: Assay Calibrations.

Dilution (Field) For patient samples, enter the dilution factor for any sample you dilute prior to loading onto the system. The default value is 1 (no dilution 1/1). You can change the default to a new value from 1-999. The system multiplies the test result by the number you enter.

For quality control and calibration samples, this field is unavailable.




Sample Type (Field) For patient samples, select the type of fluid in the sample container.

Before you enter or download test requests for a sample, the default is Serum. After you enter or download test requests, the default changes to the sample type configured for the first selected test. To change it, select another sample type.

Values are: Serum, Urine, CSF, W. Blood, Plasma, Other, Amniotic, Urethral, Cervical, or Synovial.

If you want to process more than one sample type for the same patient, you must enter separate test requests using a unique sample ID for each sample type.

For quality control and calibration samples, the system supplies the sample type configured for the quality control or calibrator.

STAT (Box) For patient samples, select to process the sample with STAT priority (before all other samples). Clear to process the sample with routine priority.

Because STAT samples are processed before calibrations, verify that all tests requested for a STAT sample have an active assay calibration (see Chapter 6: Assay Calibrations).

Comment (Pen or Notepad Button) For patient and quality control samples, select to display the Sample Comment window and add, edit, or delete sample comments.

If there are no comments associated with the sample, the system displays the Pen button.

If a comment has been entered for a sample, the system displays the Notepad button.

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

Completion (Field) Displays the estimated time the system will finish processing all tests requested for the sample. The format of this field is defined when you configure the system.

If the system has not started processing any of the tests, this field is blank. If the system schedules a reflex test for the sample, the system recalculates the completion time.

Status (Field) Displays the sample status, as determined by the least processed test requested for the sample. For more information, see the Sample Status topic in Section 4.4: Monitoring Sample Progress.

If the system cancels a test, it records the test name and sample ID on the Event Log screen and the Event Log button turns red.




Selected Tests (Field) Displays a list of all tests requested for the sample. The tests requested for the sample are also called the test list.

For patient, quality control, and calibration samples, the system indicates replicates by a number in parentheses after the test name. For calibration and quality control samples, the system displays the reagent lot number in parentheses after the test name.

To add, delete, or edit tests from the selected tests list, use the Test menu.

For more information about using the Test menu, see the Entering Patient Test Requests Manually procedure in this section.

Load Rack X F1 or

Get/Edit Rack X F1

(Button) X is the rack ID of the rack selected on the Sample Manager screen. If the selected rack is off board, select Load Rack X F1 to load it. If the selected rack is on board, select Get/Edit Rack X F1 to present the rack at the sample carousel door, where you can unload the rack, add, remove, or rearrange samples.

Delete Sample F2 (Button) Select to delete all selected sample information from the Test Requests screen.

You can only delete a sample when the rack is off board, the sample status is Requested or Supply Wait, or when all of the test statuses are Requested or Supply Wait.

Show / Hide Test Menu F3

(Button) Select Show Test Menu F3 to display the Test menu. Select Hide Test

Menu F3 to hide the Test menu.

You use the Test menu to request tests to run on the selected sample. The menu moves up and down as you select a different sample position so it does not overlap the position you are entering information for. You do not have to hide the Test menu.

Test Results F4 (Button) Select to display the Test Results screen, filtered to display results for all samples on the selected rack. The sample selected on the Test Requests screen is also selected on the Test Results screen.

NOTE

When you select Test Results F4, the On-Board Patient Sample filter is automatically applied to the Test Results screen. Therefore, if you select an off-board rack on the Test Requests screen, the results for that rack will not be displayed.




Request QC F5 (Button) For quality control samples, select to display the Request QC window. You use the Request QC window to select the name of the quality control you want to run from a list of quality controls defined across all systems in a workgroup.

When the selected sample position contains a patient sample or calibration request, the system displays an error message.

Request CalibrationF6

(Button) For calibration samples, select to display the Request Calibration window. You use the Request Calibration window to select the calibrator you want to run from a list of calibrators defined across all systems in a workgroup.

When the selected sample position contains a patient sample or quality control request, the system displays an error message.

Clear All Samples F7

(Button) Select to clear all sample fields for the current rack.

More Options F8 (Button) Select to display a menu of the following options:

• Turn Batch Request On/Off F1

If you are not using an LIS, after you enter the sample IDs and select tests for the first sample, select to request the same tests for subsequent samples. When you turn Batch Request on, the system displays Batch Request on the top right side of the screen.

• Turn Auto Sample ID On/Off F2

If you are not using bar-coded sample IDs, after you enter the first sample ID, select to enter sample IDs automatically for subsequent samples. Each ID will be numerically increased by 1. When you turn Auto Sample ID on, the system displays Auto Sample ID on the top right side of the screen.

• Request Service Assay F3

Displays the Request Service Assay window. Use this window only as directed by your technical support representative.




Navigating the Test Requests Screen

If you are using the keyboard to navigate the Test Requests screen, the cursor movement on this screen is different from other screens.

When you go to the Test Requests screen, the cursor will be in the Sample ID field for the first position on the rack. You can press [Tab] to move the cursor through the subsequent fields. Pressing [Tab] moves the cursor through the fields in this order:

• Patient ID/Lot Number

• Test Menu

• Dilution

• Sample Type

• STAT

You can press [Enter] to validate information you enter into a field, and to move the cursor through a limited number of fields. From the Sample ID field, pressing [Enter] moves the cursor through the fields in this order:

• Patient ID/Lot Number

• Test Menu

• To the next Sample ID field

NOTE

To access the Comment window you must select the Pen or Notepad button. You cannot navigate to this window using the [Tab] or [Enter] keys.

You can use the up and down arrow keys to move the cursor vertically through the sample positions.

You can use the left and right arrow keys to move the cursor through the fields in the same order as the [Tab] key. However, once you enter information into an editable field, these arrow keys move the cursor through the field by individual characters until you reach the end of the field.



0621C.wmf

Figure 3-8 Processing LIS Test Requests Flowchart

Processing LIS Patient Test Requests

If you are using bar-coded sample containers and are downloading test requests from an LIS, use this procedure to load racks and run the tests. You can load up to six racks at one time.

NOTES

• If you want to load another rack after you select Run (the last step of the procedure), you must wait for the system to update all of the tests before you continue. You can avoid waiting if you load all the racks at the same time.

Sample Manager

Place sample(s) in the rack

All racksloaded?No

Main Menu

Load rack and selectDone F1

System downloadstest requests from LIS

Sample ManagerF1

Load a RackF1

Run

Verify downloadedsample and test

information and makeany necessary changes

Yes



• Be sure that the rack and sample ID bar code label is in good condition and is properly affixed to the rack. For more information about properly applying rack ID bar code labels, see Section A.1: Racks.

• Be sure the appropriate tests are enabled before entering test requests. The system will reject an LIS test request if the associated test has not been enabled. For more information about enabling tests, see Section 4.4: Test Setup in the Reference Manual.


Place the samples in the rack(s). For information about how to do this, see the Placing Sample Containers in Racks procedure in this chapter.

For information about sample containers and volumes, see Appendix A: Racks and Sample Containers in this manual. For assay-specific sample volume information, see the reagent instructions for use.

Select Load a Rack F1.


The instrument presents a rack position in the sample carousel.

Load a rack (see the Loading Racks procedure in this chapter).

Select Done F1.

The system waits a few seconds to see if you want to load another rack. After a few seconds, the system assumes you are done loading racks. The internal bar code reader scans the bar-coded rack and sample IDs, and the system downloads test requests from the LIS.

NOTE

After the system starts scanning, you can interrupt the scan to load another rack. The system cancels the scan as soon as you select Load a Rack F1. However, there is a slight delay before it presents the rack position.

(Optional) To load another rack, repeat step 3 through step 5.


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6



Verify scanned and downloaded sample and test request information and make any necessary changes.

NOTE

If you already entered sample IDs on the Test Requests screen, and the sample IDs scanned do not match the IDs you entered, the system uses the sample IDs you entered.

To start sample processing, select Run.

For more information about sample processing, see the Starting Sample Processing procedure in Chapter 4: Sample Processing.

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0618D.wmf

Figure 3-9 Entering Patient Test Requests Manually Flowchart

Main Menu

All racks loaded?

Sample ManagerF1

Sample Manager

Enter rack IDor select rack button from Off Board list

Test RequestF3

Test Requests

Enter sample ID, test requests, and sample

information

Load Rack XF1

Run

Back


Place samples in racks

Yes

No



Entering Patient Test Requests Manually

If you have disabled sample bar code scanning, or need to enter test requests and sample information manually, use this procedure to manually enter test requests.

NOTES

• Do not enter a quotation mark (") in an available field. If you do, characters to the right of the quotation mark may not print on reports.

• If you want to load another rack after you select Run (the last step of the procedure), you must wait for the system to update all of the tests before you continue. You can avoid waiting if you load all the racks at the same time.

• To add test requests to samples in an on-board rack, see Section 3.5: Working with On-Board Samples.

• You can use other procedures in this chapter to enter test requests for calibration or quality control samples, and place these samples in the same rack with patient samples.

• Be sure that the rack ID bar code label is in good condition and is properly affixed to the rack.


Select the rack button from the Off Board list, or enter the rack ID in the Rack

ID field and press [Enter].


In the Sample ID field, enter the sample ID and press [Enter].

NOTE

If you will be entering additional samples, you can use the Auto Sample ID option to simplify entering this information. For more information, see the Using Auto Sample ID procedure in this chapter.

(Optional) Enter the patient ID.

Using the Test menu, select the tests you want to run on the sample.

If the Test menu is not shown, select Show Test Menu F3 to display the menu.

NOTE

If you will be entering additional samples, you can use the Batch Request option to simplify entering this information. For more information, see the Using Batch Request procedure in this chapter.

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0697B.bmp

Figure 3-10 Test Menu (Patient Samples)

Review the values for the Dilution, Sample Type, STAT, and Comment fields and edit them if necessary.

(Optional) To enter additional samples, repeat step 4 through step 6 for each additional sample.

NOTE

If you are entering a STAT sample, verify that the tests requested have active calibrations.

(Optional) To delete a test for a sample, select the test in the menu list and select Remove.

Place the samples in the rack. For information about how to do this, see the Placing Sample Containers in Racks procedure in this chapter.

Tests Requested for Sample X

(List) Displays test names selected to run on the sample (X is the selected sample position). Displays the number of selected replicates in parentheses after the test name.

Test (Field) Displays the test ID or test name for the selected test. You can type a test ID or test name in this field to request the test instead of using the test buttons. You can add a test replicate with the [+] key, or subtract a test replicate with the [-] key.

Remove (Button) Select this button to remove one replicate of the test selected in the Tests

Requested for Sample X list.

Test Buttons (Buttons) Each button displays the test name and test ID for an available test or test panel. Select to add one replicate of the test. If you select a button for a test panel, one replicate of each individual test associated with that panel is added to the Tests Requested list.

Table 3-11 Test Menu (Patient Samples) Descriptions

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Select Load Rack X F1.

Load the rack and select Done F1.

For more information about how to load a rack, see the Loading Racks procedure in this chapter.

(Optional) To load another rack, select Back to return to the Sample Manager screen, then repeat step 2 through step 9.

NOTES

• When configuring the system, you can disable sample ID bar code scanning, but tube detection and rack ID scanning are always enabled. If the internal bar code reader cannot read a rack ID, you must relabel the rack with a readable label or use a different rack.

• If the rack ID you entered does not match the rack ID scanned, the system displays an error message. You must return to the Sample Manager screen, unload the rack, and either load the right one or change the rack ID.

• If the tube detector does not detect a sample container in a position that has requested tests, the system deletes the sample from the Test Requests screen.


For more information about sample processing, see Section 4.1: Sample Processing.

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0512C.wmf

Figure 3-12 Using Auto Sample ID Flowchart

Main Menu

Enter test requestinformation

More samples?

Yes

Test Requests

Enter sample ID for first sample

Sample ManagerF1

More OptionsF8

Turn Auto Sample ID OnF2

Run

Sample Manager

Select or enter the rack ID and press [Enter]

Test RequestF3

No Add samples to rack and load rack

Select the next sample position

The system automatically enters

the sample ID



Using Auto Sample ID

The Auto Sample ID option simplifies test request entry when you are not using bar-coded sample IDs, and your sample IDs are consecutive. After you enter the first sample ID, the system enters sample IDs automatically for subsequent samples. Each ID will be numerically increased by 1.

For example, if the first sample ID is PAT11, the next sample ID will be PAT12, and so on. If the first sample ID ends with a non-numeric character, the system adds a 1 to the next sample ID and then increments subsequent sample IDs. For example, if the initial sample is SampleA, the next sample ID will be SampleA1, the next will be SampleA2 and so on.

Use this procedure to turn the Auto Sample ID option on or off during the Entering Patient Test Requests Manually procedure.

Go to the Test Requests screen. To get to this screen from the Main Menu, select Sample Manager F1.

Select or enter the rack ID and press [Enter].

Select Test Request F3. Type the sample ID for the first sample and press [Enter].

Select More Options F8, then select Turn Auto Sample ID On F2.

Enter the rest of the test request information for the sample.

Select the next sample position.

The system automatically enters the next incremental sample ID in the Sample

ID field. Use the [Enter] key or [Tab] key after each entry, so the system recognizes your input.

(Optional) To alter the sample ID sequence, select the Sample ID field and enter a new ID.

Continue entering test request information.

The system continues to supply an incremented sample ID for each sample until you turn off the option or exit the Test Requests screen.

(Optional) To turn off Auto Sample ID, select More Options F8, then select Turn Auto Sample ID Off F2.

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0513C.wmf

Figure 3-13 Using Batch Request Flowchart

Done entering samples?

Main Menu

Test Requests

Type sample ID for the first sample and select tests to

run

More OptionsF8

Turn Batch Request OnF1

Sample ManagerF1

The system automatically selects

same tests for next sample

Test Requests

Select next sample position

Run

Sample Manager

Select or enter the rack ID and press [Enter]

Test RequestF3

Add samples to rack and load rack

No

Yes



Using Batch Request

The Batch Request option simplifies test request entry when you are not using an LIS to download test requests. You can use this option if you are manually entering sample IDs, but it is most effective if you use it along with bar-coded sample IDs. After you request tests for the initial sample, the system assigns the same tests to subsequent samples.

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

Go to the Test Requests screen. To get to this screen from the Main Menu, select Sample Manager F1.

Select or enter the rack ID and press [Enter].

Select Test Request F3. Type the sample ID and enter the tests you want to run, then press [Enter].

Select More Options F8, then Turn Batch Request On F1.

Enter the rest of the test request information for the sample.

Select the next sample position, enter the sample ID, and press [Enter].

The system automatically selects the same tests for the sample in the position you selected.

Continue entering test request information.

The system continues to select the same tests for each sample until you turn off the option or exit the Test Requests screen.

(Optional) To turn off Batch Request, select More Options F8, then Turn Batch Request Off F1.

Reusing Sample IDs

You must delete a sample ID from the system before it can be reused.

In order to reuse a sample ID, you must first complete the following steps.

On each instrument in the workgroup, unload and clear all racks that contain the sample ID. For more information, see Section 3.1: Sample Management.

Delete all test results associated with the sample ID. For more information, see Section 5.3: Managing Test Results. To configure the system to automatically delete test results, see Section 4.10: PC Administration Setup in the Reference

Manual.

Be sure each test you will request for the reused sample ID is enabled. For more information, see Section 4.4: Test Setup in the Reference Manual.

Delete all work pending tests associated with the sample ID. For more information, see Section 4.3: Work Pending.

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3.3: Calibration Test Requests Access 2 Operator’s Guide

3.3Calibration Test Requests

Calibrators are samples of known reactivity specific for calibrating an assay on the Access 2 system. You run calibration samples on the Access 2 system to establish values the system uses to assess test results for patient and quality control samples. The system requires an active (accepted, not expired) assay calibration for each requested test.

You run a calibration by setting up a set of calibrators specific for an assay or group of assays. Each calibration is associated with a specific reagent pack lot number.

You can run a calibration at any time, or when the system prompts you. Beckman Coulter recommends that you perform assay calibration under the following circumstances:

• When you switch to a new reagent lot, or to a new reagent shipment within the same lot

• When the active calibration has expired

• When quality control data indicates calibration is necessary

• When a major system component has been repaired or replaced

NOTES

• You must configure each new lot of calibrators before you can use them for a calibration.

• Some assays require temperature restrictions. See Appendix A of the Access 2 Instructions for Use manual for information on these restrictions.

For information about how to edit or delete calibration test requests, see Section 3.5: Working with On-Board Samples.

For information about how to load a new reagent pack, see Chapter 2: Supplies.

For information about how to review calibration data and determine if a test has an active assay calibration, see Chapter 6: Assay Calibrations.

3-38 2015 Beckman Coulter, Inc.P/N B14251E 2/15

Access 2 Operator’s Guide 3.3: Calibration Test Requests

0510C.wmf

Figure 3-14 Entering Calibration Test Requests Flowchart

Main Menu

Test Requests

System enters calibration set lot number, calibrator levels, and reagent pack

lot number

Test Requests

System enters each calibrator level in

subsequent sample positions

Request CalibrationF6

Sample ManagerF1

Load Rack XF1


Sample Manager

Select off-board rack orenter rack ID and

press [Enter]

Test RequestF3

Request Calibration

Select calibration set

OKF1

Run



Entering Calibration Test Requests

Use this procedure to enter test requests for a set of calibration samples.

NOTES

• The system processes calibration samples before quality controls and routine patient samples.

• You must set up each new calibrator before you can perform a calibration using that lot.





Select Request Calibration F6.

The Request Calibration window is displayed

2164B.bmp

Figure 3-15 Request Calibration Window

Select the appropriate calibrator set, then select OK F1.

The system enters each calibrator level in subsequent sample positions on the Test Requests screen. The selected test and the current reagent pack lot number for that test display on the calibration view of the Test menu.

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Access 2 Operator’s Guide 3.3: Calibration Test Requests

0698B.bmp

Figure 3-16 Test Menu (Calibration)

(Optional) To change the reagent lot for a calibrator, select the calibrator set, then select Change Reag. Lot. For more information about changing the reagent lot, see the Changing the Reagent Lot for Running Calibrations or Controls procedure in this chapter.

(Optional) To change the calibration test, select Delete Sample F2, then return to step 4.

(Optional) To hide the Test menu, select Hide Test Menu F3.

Place the samples in the rack(s). For information about how to do this, see the Placing Sample Containers in Racks procedure in this chapter.

NOTE

Be sure that each calibrator in the set is in the same type of sample container, then place the calibration samples for the entire calibration set in the same rack.


Reagent (List) Displays the test name associated with the selected calibrator.

Reagent Lot (List) Displays the selected reagent lot number associated with each selected test.

Test (Field) Displays the test ID or test name for the selected test.

Change Reag. Lot (Button) Select to display the Change Lot Number window and choose a different reagent lot.

NOTE

You can only change the reagent lot if the sample status is Requested.

Table 3-17 Test Menu (Calibration) Descriptions

6



Load the rack (see the Loading Racks procedure in this chapter).

(Optional) To request additional calibration sets, repeat step 2 through step 6. Or, use other procedures in this chapter to request patient or quality control samples.



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Access 2 Operator’s Guide 3.4: Quality Control Test Requests

3.4Quality Control Test Requests

Quality control samples are commercially available samples of known reactivity. You run quality control samples along with patient samples to monitor analytical variation on your Access 2 instrument and to ensure the validity of patient sample results.

You run quality controls by entering a quality control test request for a quality control sample or set of samples. When you enter a quality control test request, you select a specific quality control lot number from the Request QC window.

You should run quality control samples as recommended in the QC instructions for use and after any scheduled or unscheduled maintenance to verify assay calibration. Also, after successfully installing new software, Beckman Coulter recommends running quality controls for all assays you use to report patient results, then recalibrating any assays with out of range QC results.

To best simulate the characteristics of patient samples, use quality control samples prepared from material similar to the patient samples you are testing. For example, if testing serum, use serum-based quality control samples.

NOTE

You must set up each new quality control lot in the Access 2 system before you can select it during test request entry.

For information about how to edit or delete quality control test requests, see Section 3.5: Working with On-Board Samples.

For information about how to review quality control data, see Section 7.2: Reviewing Quality Control Charts and Data.


3.4: Quality Control Test Requests Access 2 Operator’s Guide

0511C.wmf

Figure 3-18 Entering Quality Control Test Requests Flowchart

Main Menu

Sample ManagerF1

Test Requests

Request QCF5

Test Requests

Load Rack XF1

Sample Manager

Enter rack ID and press [Enter]

Test RequestF3

Request QC

Select a single or multi-level quality control

OKF1


Run



Entering Quality Control Test Requests

Use this procedure to enter a test request for a quality control sample or set of samples.




Select Test Request F3 to display the Test Requests screen, then select Request QC F5.

The Request QC window is displayed.

2047C.bmp

Figure 3-19 Request QC Window

NOTE

The Request QC window displays the quality controls set up on all systems in a workgroup.

Select a single or multi-level quality control, then select OK F1.

The system enters the selected quality controls in the next available sample position(s) on the Test Requests screen, then displays the QC view of the Test menu.

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3.4: Quality Control Test Requests Access 2 Operator’s Guide

0699B.bmp

Figure 3-20 Test Menu (QC)

Select the tests you want to run on the QC sample. The Reagent list in the Test menu displays the selected tests.

(Optional) To set the reagent lot for a test, select the test, then select Change

Reag. Lot. For more information, see the Changing the Reagent Lot for Running Calibrations or Controls procedure in this chapter.

(Optional) To hide the Test menu, select Hide Test Menu F3.

Reagent (List) Displays the tests selected to run on the quality control sample.

Reagent Lot (List) Displays the reagent lot number if you have changed the lot number for the selected test.

If you do not change the reagent lot number, no reagent lot is listed. The system selects a lot number when processing begins.

Test (Field) Displays the test ID for the selected test. You can use this field to enter the test to run on the quality control sample instead of using the test buttons.

Change Reag. Lot (Button) Select a test from the Reagent list, then select this button to display the Change Lot Number window and choose a different reagent lot.

NOTE

You can only change the reagent lot when the sample status is Requested.

Remove (Button) Select a test from the Reagent list, then select this button to remove one replicate.

Test Buttons (Buttons) Each button displays the test name and test ID for an available test or test panel. Select to add one replicate of the test. If you select a button for a test panel, one replicate of each individual test associated with that panel is added to the Reagent list.

Table 3-21 Test Menu (QC) Descriptions

5



(Optional) To enter or edit comments, select the Pen or Notepad button. For more information, see the Entering Sample Comments procedure in this chapter.

Place the QC samples in the rack(s). For more information, see the Placing Sample Containers in Racks procedure in this chapter.


Load the rack(s). For more information, see the Loading Racks procedure in this chapter.


For more information about sample processing, see Section 4: Sample Processing.

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3.5: Working with On-Board Samples Access 2 Operator’s Guide

3.5Working with On-Board Samples

The Access 2 system allows continuous access to sample information. You can edit active test request fields, select additional tests, cancel selected tests, delete tests, and add, remove, or rearrange samples while the system continues processing.

If the sample rack containing the sample you want to work with is on board, and the system is in the Running mode, you must stop aspiration activity before working with the on-board sample by pausing the instrument or getting the rack. Pausing the instrument does not affect tests already in progress.

NOTE

In general, if you use an LIS to download test requests, you should use the LIS to add, edit, or delete test requests. The LIS expects to receive results from the Access 2 system for all tests downloaded for a sample. If you use the Test menu to delete a downloaded test request, the Access 2 system does not inform the LIS of the deletion, and the LIS continues to expect a result for the test. Likewise, if you use the Test menu to add a test request, the LIS may not recognize uploaded results for the added test. See your LIS documentation or contact your LIS vendor for details.

For information about how to load, unload, and clear racks, and to change rack IDs, see Section 3.1: Sample Management.


Access 2 Operator’s Guide 3.5: Working with On-Board Samples

0848B.wmf

Figure 3-22 Adding, Removing, and Rearranging On-Board Samples Flowchart

Adding, Removing, and Rearranging On-Board Samples

Use this procedure to access an on-board rack so you can add, remove, or rearrange samples.


Main Menu

Sample ManagerF1

Sample Manager

Enter rack ID and press[Enter] or select rack from

the On Board list

Get Selected RackF6

Get Selected Rack

System presents therack

Open sample carouseldoor, then add, remove,

or rearrange samplesand close door

DoneF1

Internal bar code readerscans the rack for

changes

Run



NOTES

• If you are using the internal bar code reader to scan sample IDs, you should only work with on-board samples without unloading the rack.

• If sample ID scanning is disabled, you can unload the rack, add, remove, or rearrange samples as you edit the necessary information on the Test Requests screen, and then reload the rack.


Select the rack you want to work with from the On Board list.

Select Get Selected Rack F6.


The instrument presents the rack, and the Get Selected Rack window is displayed.

CAUTION

If the rack status is Aspirated, the system displays a warning message that reflex tests could be scheduled for samples on that rack. If you choose to remove samples scheduled for reflex tests from the rack, the system will display the scheduled reflex tests on the Work Pending screen. You will have to reload the sample(s) to run the reflex tests.

The system continues to process any aspirated samples.

Open the sample carousel door and add, remove, or rearrange samples. You do not need to unload the rack.

Select Done F1 in the Get Selected Rack window.

The internal bar code reader scans the rack(s) for changes. If you added samples and are using an LIS and bar-coded sample IDs, the system downloads patient test requests for the new samples.

(Optional) To add, remove, or rearrange samples on another on-board rack, repeat step 2 through step 5.



For more information about sample processing, see Section 4: Sample Processing.

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0514C.wmf

Figure 3-23 Editing Test Requests for On-Board Samples Flowchart

Main Menu

Test Requests

Edit test request information

Sample ManagerF1

All samples edited?

Yes

No

Select rack button in OnBoard list

Sample Manager

Test RequestF3

System entersPaused mode

System processing samples?

No

Run

Test Requests

Get/Edit Rack X F1

DoneF1

Yes



Editing Test Requests for On-Board Samples

Use this procedure to edit a test request for a sample in an on-board rack.


In the On Board list, select the rack with the test request to be edited.

Select Test Request F3.

The Test Requests screen is displayed.

Select Get/Edit Rack X F1.

If the system is processing samples, the system displays a message that shows you the time remaining until the system can present the requested rack.

The system enters the Paused mode and presents the selected rack. Do not

unload the rack.

Select the sample position containing the test request to be edited.

Edit any of the information in the following fields:

• Sample ID

• Patient ID or Lot Number

• Dilution

• Sample Type

• STAT

• Comment

NOTES

• If you edit the sample ID for a test request, all information associated with that sample, including the tests you have requested, is removed from the test request.

• For any instrument in a workgroup, the patient ID cannot be edited after a test associated with the sample ID has been pipetted.

For more information about these fields, see the Test Requests screen descriptions (see Table 3-7).

(Optional) To edit tests, select Show Test Menu F3. Select the test you want to edit.

To start or continue sample processing, select Done F1, then select Run.


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0517C.wmf

Figure 3-24 Deleting Test Requests for On-Board Samples Flowchart

Sample Manager

Select rack with the sampleyou want to delete a test

request from

Main Menu

Sample ManagerF1

Select the sample with the test request to be

deleted

Test RequestF3

Test Requests

Get/Edit Rack XF1

Select the test to be deleted from the Test Requested

for Sample X list

RemoveF2

DoneF1

Run



Deleting Test Requests for On-Board Samples

Use this procedure to delete a test request for a sample in an on-board rack.

NOTE

You can delete a test request only if the sample status is Requested, In

Progress, or Supply Wait.

Go to the Sample Manager screen.To get to this screen from the Main Menu, select Sample Manager F1.

In the On Board list, select the rack containing the sample with the test request to be deleted.



Select Get/Edit Rack X F1.

If the system is processing samples, the system displays a message that shows you the time remaining until the system can present the requested rack.

The system enters the Paused mode and presents the selected rack. Do not

unload the rack.

Find the sample containing the test request to be deleted.

In the Test menu, select the test to be deleted from the Tests Requested for

Sample X list.

Select Remove F2.

(Optional) To delete a calibration set, select Delete Sample F2.

To start or continue sample processing, select Done F1, then select Run.


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0934B.wmf

Figure 3-25 Adding Test Requests to On-Board Samples Using the Pause Button Flowchart

Sample Manager

Select rack with the sampleyou want to delete a test

request from

Main Menu

Sample ManagerF1

Select the sample with the test request to be

deleted

Test RequestF3

Test Requests

Get/Edit Rack XF1

Select the test to be deleted from the Test Requested

for Sample X list

RemoveF2

DoneF1

Run



Adding Test Requests to On-Board Samples Using the Pause Button

Use this procedure to add a test request for a sample in an on-board rack using the Pause button.

NOTE

The instrument must be in the Running mode to use this procedure.


In the On Board list, select the rack containing the sample that requires additional test requests.



Select Pause.

The system enters the Paused mode, but does not present the selected rack.

Select the sample that requires additional test requests.

In the Test menu, select the test(s) to be added to the sample.

To resume sample processing, select Run.

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0935B.wmf

Figure 3-26 Deleting Test Requests from On-Board Samples Using the Pause Button Flowchart

Sample Manager

Select rack from the On Board list

Main Menu

Sample ManagerF1

Select sample containing the test

request to be deleted

Test RequestF3

Test Requests

Pause

Select the test to be deleted from the Test

menu

RemoveF2

Run



Deleting Test Requests from On-Board Samples Using the Pause Button

Use this procedure to delete a test request for a sample in an on-board rack using the Pause button.

NOTE

The instrument must be in the Running mode to use this procedure.


In the On Board list, select the rack containing the sample with the test requests to be deleted.

NOTE

You cannot delete test requests if the rack status is In Progress, Aspirated, *Done*, or Done.



Select Pause.

The system enters the Paused mode, but does not present the selected rack.

Select the sample with the test requests to be deleted.

In the Test menu, select the test to delete from the sample.

Select Remove F2.

NOTES

• You cannot delete test requests from samples that have any of the following sample statuses: In Progress, Aspirated, or Done.

• If the sample has test requests that are Requested and In Progress, you can delete any test requests with the Requested status. If you delete all Requested test requests, the sample status changes to In Progress.

To resume sample processing, select Run.

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Access 2 Operator’s Guide 4: Sample Processing

4Sample Processing

4.1 Sample Processing ........................................................................................4-2

Starting Sample Processing...............................................................................4-5

Pausing Sample Processing...............................................................................4-5

Stopping Sample Processing .............................................................................4-6

Sample Processing Order ..................................................................................4-7

LIS Request Container Assignment ..................................................................4-8

4.2 Supply and Calibration Conditions .......................................................... 4-11

Supplies Required Screen ...............................................................................4-13

Requesting Verification of Supplies and Calibrations .................................... 4-16

Overriding Supply Conditions ........................................................................ 4-16

Printing Supplies Required ............................................................................. 4-17

4.3 Work Pending ............................................................................................... 4-19

Work Pending Screen......................................................................................4-20

Applying a Filter to Work Pending................................................................. 4-22

Deleting Work Pending Tests ......................................................................... 4-23

Printing Work Pending.................................................................................... 4-24

4.4 Monitoring Sample Progress...................................................................... 4-25

Rack Status......................................................................................................4-25

Sample Status .................................................................................................. 4-27

Test Status ....................................................................................................... 4-27


4.1: Sample Processing Access 2 Operator’s Guide

4.1Sample Processing

Sample processing begins after you verify supplies, load samples, enter or verify test request information, and select Run.

The Access 2 system is dynamic. When you select Run, the system automatically determines the optimal sample processing order and immediately begins to process the samples it can. The system alerts you if you need to replenish supplies, calibrate any test, or respond to the system in any other way. For the most efficient throughput, verify that the instrument has the supplies and valid calibrations needed to process all samples before you select Run.

If you are using an LIS to enter patient test requests and the system is in the Running mode, the system automatically downloads the requests as they are received.

• If the sample for downloaded test requests is on board, the system adds the requests to the current run. If supplies and calibrations are sufficient, the system automatically processes the downloaded tests. You do not need to select Run again. If supplies or calibrations require attention, the system assigns the Supply Wait status to the tests it cannot process, and the Supplies Required button turns yellow. You must load supplies, change waste containers, or recalibrate before the system can process the tests with Supply Wait status.

• If the sample for downloaded test requests is not on board, the system puts the test requests in the work pending list, and the Work Pending button turns yellow. You must load the sample before the system can process the downloaded test requests.

While the system is processing tests, you can monitor the progress of each on-board sample and requested test.

You can process multiple containers with the same sample ID on multiple instruments. However, you cannot process multiple containers with the same sample ID concurrently on the same instrument.


Access 2 Operator’s Guide 4.1: Sample Processing

The Access 2 system allows continuous access, so you can add or remove most supplies, add or remove samples or racks, or change waste containers during processing. You can also pause processing to add or delete test requests.

NOTES

• You cannot change the substrate bottle while the system is in the Running mode.

• You cannot load or unload racks or supplies or add or delete tests for on-board racks while maintenance routines are in progress.

If you configured your system with reflex testing enabled, the system orders reflex tests automatically when the defined conditions are met and the sample is on board an instrument in the workgroup.

To be sure the Access 2 system continues to run efficiently, you must perform routine daily and weekly maintenance procedures.

For information about how to load samples and enter or verify test request information, see Chapter 3: Sample Management.

For more information about reflex testing, see Chapter 4: System Configuration in the Reference Manual.

For information about how to perform maintenance procedures, see Chapter 8: Routine Maintenance.



0518B.wmf

Figure 4-1 Processing Samples Flowchart

Run

(optional)Monitor progress

View resultsPrint results

Supplies orcalibrationrequired?

Samplesrequired?

any screen

Supplies Required

No

Yes

Correct thecondition now?

Yes

Load supply,change wastecontainer, or

request calibration

Overrideexpired supply/

calibration?

OverrideF8

Yes

No

any screen

Work Pending

Yes

(optional)Apply filter

Load samplesDelete samples

Print report

Select Run if system isnot in Running mode

No

(optional)Monitor progress

View resultsPrint results

No



Starting Sample Processing

Use this procedure to begin processing samples after you verify supplies, load samples, and enter or verify test request information.

Select Run.

The Access 2 system determines the testing sequence and begins the tests it can complete under current conditions.

NOTE

You cannot select Run from a limited number of screens, such as Diagnostics screens.

If a test requires calibration or the system needs any supplies, the Supplies

Required button turns yellow. If the system requires samples, the Work

Pending button turns yellow. If the system detects an operational error, the Event Log button turns yellow or red. Select the button to display the corresponding screen.

For information about Supplies Required, see Section 4.2: Supply and Calibration Conditions.

For information about Work Pending, see Section 4.3: Work Pending.

For information about the Event Log, see Chapter 6: Event Log in the Reference

Manual.

NOTES

• When the system has completed or cancelled the last test on the last on-board rack, it automatically rinses the aspirate probes by running the Utility Assay.

• Unless there is an emergency, let the Utility Assay run to completion.

Pausing Sample Processing

Use this procedure to temporarily pause the instrument when it is in the Running mode.

NOTES

• You cannot pause the instrument during a maintenance routine.

• You can make changes to on-board samples and test requests while the system is in the Paused mode. For more information, see Section 3.5: Working with On-Board Samples.

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Select Pause from any screen.

The Access 2 system stops pipetting after the current sample and does not schedule any new tests until you restart processing. The system continues processing samples already in progress.

Stopping Sample Processing

Use this procedure to stop sample processing.

WARNINGS• Unless there is an emergency, let maintenance routines run to completion.

Cancelling a routine may damage the instrument and compromise the integrity of subsequent test results.

• If you stop a maintenance routine, do not initialize the system. Contact Technical Support for assistance.

CAUTION

Stopping processing cancels any tests in progress and may leave devices away from their home positions. After you stop processing, you must initialize the system and run the Utility Assay before you can start processing again.

Select Stop from any screen.


Select Yes F1.

The system stops processing and cancels any tests in progress.

For detailed information about the Utility Assay, see Chapter 8: Routine Maintenance.

For detailed information about initialization, see Chapter 5: Diagnostics in the Reference Manual.

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SampleProcessingOrder

When you start sample processing, the system determines the optimal processing order using the following criteria, and begins processing the samples with the highest priority first.

The system processes all STAT samples first, in the order you loaded them onto the instrument. Next, the system processes calibration samples. Then, the system processes routine patient samples and quality control samples with the same priority, in the order you loaded them onto the instrument. Last, the system runs maintenance routines.

NOTE

If a STAT patient sample has a requested test that is not calibrated, you must calibrate the assay before you load and run the STAT sample.

Within a rack, the system typically processes all tests of a given type together to maximize throughput. For example, the system will process all Cortisol tests requested for samples in a rack, then all Thyroglobulintests, and so on.

If your system is set up to automatically print reports, the result reports for patient samples print when testing is complete, according to the priority criteria. For more information about result reports, see Chapter 5: Test Results.

Priority Criteria

1 Type:

1st—STAT patient samples

2nd—Calibration samples

3rd—Quality control samples and routine patient samples

2 Date and time the rack was loaded (first on, first processed)

3 Assay (depends on the assay protocol file [APF])

4 Sample position within the rack (in order from first position to tenth position)

5 Maintenance routines

Table 4-2 Sample Processing Order Criteria



LIS Request Container Assignment

When the system receives an LIS test request, it uses a set of rules to determine which instrument and sample container it will assign the request to. If a test request is not assigned to a sample container right away, the system stores it in the LIS workpool, and the Work Pending button turns yellow. The test request in the LIS workpool can be viewed on the Work Pending screen. When one of the rules is satisfied, the system assigns the pending test request to the appropriate sample container.

NOTE

Be sure the appropriate tests are enabled. The system will reject an LIS test request if the associated test is not enabled on at least one instrument in the workgroup.

If the LIS interface is enabled (configured on), the Access 2 system is always open to receive broadcast downloads of test requests. When a rack is loaded, the system searches the LIS workpool for test requests for sample IDs scanned by the bar code reader, and repeats the search every few seconds when in the Running mode.

You can also enable or disable host query for each instrument. If host query is enabled, the Access 2 system can ask the LIS for new test requests, instead of waiting for a broadcast. When a rack is loaded and the system finds no test requests in the workpool for any of the loaded sample IDs, the system queries the LIS for test requests. A test request received by host query is always assigned to the instrument that generated the query, if the test is enabled.

The rules for assigning a test request to a sample container differ depending on:

• How many instruments are in the workgroup

• How many of the instruments in the workgroup have the test enabled

• How many sample containers exist for the sample ID

One Sample Container, or Test Enabled on One Instrument

If the sample ID exists on only one sample container, or if the test is enabled on only one instrument, the following rules apply:

If the rack is... Then...

Just loaded onto the instrument

The system searches the test list for test requests for the samples in the rack.

• If the test requests are not in the test list, the system searches the LIS workpool.

• If the test requests are not in the workpool, and Host Query is enabled, the system queries the LIS.

Table 4-3 Rules for One Sample Container or Instrument



Multiple Containers with Same Sample ID on Multiple Instruments, or with Same Test Enabled on Multiple Instruments

For multiple sample containers with the same sample ID or when tests are enabled on more than one instrument in the workgroup, the system assigns the test using the following rules:

On board, and the instrument is in the Running mode

The system assigns downloaded test requests to the appropriate sample containers and automatically schedules them to run on the instrument.

On board, but the instrument is not in the Running mode

Downloaded test requests remain in the LIS workpool until you either:

• Select Run, or

• Get the rack and select Done F1 (reload it)

When you select Run, the rules for the Running mode apply.

If the rack is... Then...

Table 4-3 Rules for One Sample Container or Instrument (continued)

If... And... Then...

All sample containers are off board all instruments in the workgroup

The test remains in the LIS workpool until you load one of the sample containers.

The rules for one instrument (see Table 4-3) then apply.

One sample container is on board an instrument that is not in the Running mode

Every other sample container is off board all instruments in the workgroup

The test remains in the LIS workpool until you:

• Select Run, or

• Get the rack and select Done F1

(reload it), or

• Load the rack onto another instrument

The rules for one instrument (see Table 4-3) then apply.

Table 4-4 Rules for Multiple Sample Containers or Instruments



One sample container is on board an instrument that is in the Running mode and all other sample containers are on board instruments that are not in the Running mode

The test is enabled on all instruments

The system assigns the test requests to the instrument that is in the Running mode.

All sample containers are on board instruments that are in the Running

mode

The test is enabled on all instruments

The system assigns the test requests to the instrument that searches the LIS workpool or queries the LIS first.

If... And... Then...

Table 4-4 Rules for Multiple Sample Containers or Instruments (continued)


Access 2 Operator’s Guide 4.2: Supply and Calibration Conditions

4.2Supply and Calibration Conditions

Before running requested tests, the Access 2 system does the following verifications of supply quantities and expiration dates:

• Compares the requested tests to the number of tests that it can process with the on-board substrate, reaction vessels (RVs), and reagent packs

• Compares the requested tests to the remaining capacity for RV waste

• Checks if there is wash buffer available and if there is remaining capacity for liquid waste

• Checks the expiration dates of the substrate, reagent packs, reagent lots, and calibrations

• Verifies that an active calibration exists for each of the tests requested

You can manage supply and calibration requirements in the following ways:

• Manually verify supply levels and calibrations at least once a day to be sure the system can process all requested tests immediately when you start processing.

• Request the system to verify supplies and calibrations after all of the tests are requested (by you or the LIS), and before you select Run.

• Wait for the system to automatically verify supplies and calibrations after you select Run. The Supplies Required button turns yellow if the system requires supplies or calibrations.

If supply or calibration conditions are not OK for all of the tests requested, the system processes the tests it can. The system does not schedule additional tests when the current supplies are gone, calibrations are needed, or the waste containers are almost full.


4.2: Supply and Calibration Conditions Access 2 Operator’s Guide

You can start sample processing using expired supplies or calibrations by overriding current conditions. The system flags the results of tests using expired supplies or calibrations in the Event Log and on result reports.

For more information about how to verify supply levels, load supplies, and change waste containers, see Chapter 2: Supplies.

For more information about how to review calibrations, see Chapter 6: Assay Calibrations.

For more information about how to enter calibration test requests, see Chapter 3: Sample Management.




Supplies Required Screen The Supplies Required screen lists any supplies or calibrations required to complete the requested tests. You use this screen to:

To get to this screen from any screen, select the Supplies Required button.

0692A.bmp

Figure 4-5 Supplies Required Screen

• Load reagent packs and RVs

• Display the Reagent Inventory screen

• Change the substrate bottle and the RV waste bag

• Print the Supplies Required Report

• Override certain supply and calibration conditions and continue processing

Supplies Required Button

0578A.bmp

Tests Requested (Field) Displays the total number of tests requested for loaded samples with test statuses of Requested or Supply Wait. The number includes reflex tests and tests requested by the LIS.

Table 4-6 Supplies Required Screen Descriptions


Tests to Run (Field) Displays the number of tests requested for loaded samples that the system can process with the current supply levels and active calibrations.

Required (Column) Displays the action or quantity needed.

• When a reagent is low or expired, displays number of packs (X Packs) needed.

• When RVs are low, displays the number of cartridges (X Cartridges) needed.

• When there is no calibration, displays Calibrate.

• When the calibration is expired, displays Recalibrate.

• When substrate is low or expired, the RV waste bag is full, or the wash buffer is low, displays Change.

• When the liquid waste bottle is full, displays Empty.

• When no tests are requested or no supplies are needed, displays None.

Supply (Column) Displays the name of the supply required and the icon that represents the supply. Supply names are: Substrate, RVs, RV Waste Bag, Wash Buffer, Liquid

Waste, and XXX, where XXX is the name of the reagent pack. For reagent packs with primary and secondary tests, secondary tests display in parentheses after the reagent pack name for the primary test. For example: Folate (RBC Folate).

Lot Number (Column) Displays the lot number associated with the supply condition, if applicable. Otherwise, this column is blank.

Status (Column) Displays the calibration, lot, or substrate expiration status.

• When a reagent pack is expired, displays Pack Expired.

• When a reagent lot is expired, displays Lot Expired.

• When the substrate is expired, displays Expired.

• When there is no calibration, displays No Calibration.

• When the calibration is expired, displays Calibration Expired.


(Button) Select to load a reagent pack onto the instrument. For information about loading reagent packs, see Chapter 2: Supplies.

Table 4-6 Supplies Required Screen Descriptions (continued)



Reagent Inventory F2

(Button) Select to display the Reagent Inventory screen to see a list of on-board and off-board reagent packs, including the following information:

• Test name

• Lot number

• Serial number

• Tests left

• Days the reagent pack has been open

• Reagent pack expiration date

• Calibration expiration date

• Slot number (if the pack is on board the instrument)

• Instrument the reagent pack is on (if it is on board the instrument)

For information about the Reagent Inventory screen, see Chapter 2: Supplies.

Load RVs F4 (Button) Select to load RVs. For information about loading RVs, see Chapter 2: Supplies.

Change Substrate F5

(Button) Select to change the substrate bottle. You cannot change the substrate bottle when the system is in the Running mode.

For information about changing the substrate bottle, see Chapter 2: Supplies.

Change RV Waste Bag F6

(Button) Select to change the RV waste bag. For information about changing the RV waste bag, see Chapter 2: Supplies.

Print F7 (Button) Select to print the Supplies Required Report (see Figure 4-7).

Override F8 (Button) Select to continue sample processing. This button is only available when you can override a supply condition that is preventing the processing of new tests. You can override the following supply conditions:

• Expired calibrations

• Expired substrate

• Expired reagent packs or lots

• No calibration

Table 4-6 Supplies Required Screen Descriptions (continued)



Requesting Verification of Supplies and Calibrations

Before starting sample processing, you can display the Supplies Required screen to get detailed information about any supply and calibration conditions that will prevent the processing of new tests.

Use this procedure to verify supplies and calibrations.

Go to the Supplies Required screen. To get to this screen from any screen, select the Supplies Required button.

The system compares the number of requested tests to the number of tests that it can process with the on-board supplies and the remaining capacity for liquid waste and used RVs. The system also verifies the status of all requested assay calibrations and checks the expiration dates of calibrations, reagent packs, reagent lots, and substrate.

The screen lists the actions or quantities needed.

Correct or override supply or calibration conditions as necessary.

Continue sample processing.

For information about overriding conditions, see the Overriding Supply Conditions procedure in this section.

Overriding Supply Conditions

You can start sample processing using expired calibrations, substrate, reagent packs, or reagent lots by overriding the current conditions. The system applies appropriate flags to test results and logs a corresponding event in the Event Log.

You can also override a reagent pack that is not calibrated, but no test results will be generated for the assay.

NOTE

If you are recalibrating an expired calibration and running STAT tests for the assay at the same time, you must override the expired calibration. Until you select Override F8, the STAT test requests stay in the Supply Wait status.

Use this procedure to override supply conditions.


(Optional) To override some supply conditions but not others, first correct the conditions you do not want to override.

For example, you may have an expired Thyroglobulin reagent pack and a Cortisol pack with an expired calibration, and you only want to override the

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Cortisol calibration. You unload the expired Thyroglobulin pack and load an unexpired Thyroglobulin pack. You then return to the Supplies Required screen and perform the override procedure. Cortisol will be removed from the list on the Supplies Required screen and the subsequent Cortisol test results will be flagged.

Select Override F8, then select Run.

NOTE

If the system is in the Running mode, you do not need to select Run. The system pauses briefly and then runs the tests, using overridden expired supplies or calibrations.

The Access 2 system removes the overridden expired supplies or calibrations from the list on the Supplies Required screen. If no other supplies are required, the system will continue the run and flag the tests that use the expired supplies or calibrations.

Printing Supplies Required

Use this procedure to print a list of supplies required.


Select Print F7.

The system prints the Supplies Required Report (see Figure 4-7).

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0823D.bmp

Figure 4-7 Supplies Required Report


123 Lake StreetSupplies Required Report Townsville, ST 33333Access 2 Immunoassay System 101-555-2323 ext. 109S/N 500135 Jane Smith

Tests Requested 36Tests to Run 0

Required Supply Lot Number StatusChange Substrate 103187 ExpiredChange RV Waste BagEmpty Liquid Waste1 Cartridge RVsChange PSA-Hyb 008141 Pack ExpiredRecalibrate PSA-Hyb 008141 Calibration Expired

Page 1 of 1Technologist ________________________ Printed 04/04/11 03:16 PM


Access 2 Operator’s Guide 4.3: Work Pending

4.3Work Pending

The Access 2 system verifies that all necessary samples are on board while scheduling tests.

When the system requests a reflex test, accepts a downloaded LIS test request, or when you rerun a test, the system tries to find the sample on board any instrument in the workgroup.

Tests that the system cannot schedule because it cannot find an on-board sample are called work pending. When the system fails to find an on-board sample, the sample is added to the work pending list, and the Work Pending button turns yellow. You must either load the appropriate sample or delete the test request using the Delete F6 button on the Work Pending screen.

Work Pending only lists test requests for tests that are enabled on the instrument attached to the PC displaying the Work Pending screen. These test requests can originate from any system in the workgroup.

Because the system automatically deletes manually entered, unscheduled test requests if you unload and clear the sample, the system never displays manually entered test requests in the work pending list.

For information about reflex tests, see Chapter 4: System Configuration in the Reference Manual.

For information about rerunning tests with fatally flagged results, see Chapter 5: Test Results.


4.3: Work Pending Access 2 Operator’s Guide

Work Pending Screen You use the Work Pending screen to:

To get to this screen from the Main Menu, select Sample Manager F1 to display the Sample Manager screen, then select Work Pending F2. Or, select the Work Pending button from any screen.

0700B.bmp

Figure 4-8 Work Pending Screen

• View a list of off-board samples that have pending test requests

• Display the Sample Manager screen, where you can load the required samples and continue processing

• Delete pending test requests

• Print the Work Pending Report

Work Pending Button

0580A.bmp

Filter (Field) Displays the filter and sort order currently in effect.

Table 4-9 Work Pending Screen Descriptions




Samples Requested (Field) Displays the number of samples the system needs in order to complete the requested tests.

LIS Workpool (Field) Displays the number of samples in the LIS Workpool. The workpool is a list of tests that have been requested by the LIS, but that the system cannot schedule because the associated samples are not on board any instrument in the workgroup.

Sample ID (Column) Displays the sample ID of the requested sample.

Patient ID (Column) Displays the patient ID, if one exists, for the requested sample.

NOTE

A patient ID is required for LIS test requests.

Requested (Column) Displays the date and time that the sample was requested.

Tests Pending (Column) Displays the test names of all tests pending for the sample.

Origin (Rack/Instrument)

(Column) Displays the origin of the test request. Values are: Reflex, LIS, Manual

Rerun.

In parentheses, displays the rack ID and the instrument name the sample is associated with. If the sample is not associated with a rack, the rack is blank. If the sample was never loaded on an instrument, the instrument is Unknown.

Filter F1 (Button) Select to display the Filter window and apply a filter and a sort order to the Work Pending screen. The system displays the filter and sort order you select in the Filter field.

The default filter is all pending tests (all filters selected) sorted in ascending Sample ID order.

For more information about the Filter window, see the Applying a Filter to Work Pending procedure in this section.

Sample Manager F2 (Button) Select to display the Sample Manager screen to see a list of on-board and off-board racks, to load a rack, or to add a sample to an on-board rack.

For more information about loading samples and racks, see Chapter 3: Sample Management.

Delete F6 (Button) Select to display the Delete window and delete tests from the work pending list.

For more information about the Delete window, see the Deleting Work Pending Tests procedure in this section.

Print F7 (Button) Select to print the Work Pending Report.

For more information about the Print window, see the Printing Work Pending procedure in this section.

Table 4-9 Work Pending Screen Descriptions (continued)

P/N B14251D 9/14


Applying a Filter to Work Pending

A work pending filter is a set of parameters you can change to reduce or expand the number of samples displayed on the Work Pending screen.

Use this procedure to apply a different filter to the Work Pending screen.

Go to the Filter window. To get to this window from any screen, select the Work Pending button to display the Work Pending screen, then select Filter F1.

The Filter window is displayed.

0826B.bmp

Figure 4-10 Filter (Work Pending) Window

Select or clear one or more of the available filters:

• To include off-board samples with pending reflex tests in the filter, select the Off-board Reflex Tests box.

• To include off-board samples with pending rerun tests, select the Off-board Manual Rerun box.

• To include off-board samples with pending LIS test requests, select the Off-board LIS Requests box.

Filter (Boxes) Select or clear the following filter options:

• Off-board Reflex Tests

• Off-board Manual Rerun

• Off-board LIS Requests

Sort Order (Option) Select to change the sort order.

Ascending (Box) Select to sort the samples in ascending order. You can clear the box to sort the samples in descending order.

Table 4-11 Filter (Work Pending) Window Descriptions

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(Optional) Select a different sort order.

• To sort the samples in the filter by sample ID, select the Sample ID option.

• To sort the samples in the filter by the time they were requested, select the Request Time option.

(Optional) Select or clear the Ascending box to sort the samples in ascending or descending order.

Select OK F1.

The system displays all samples with tests that meet the selected filter parameters on the Work Pending screen.

NOTES

• The system uses the selected filter until you apply a different one.

• The Work Pending button turns yellow only when a pending test that fits the filter criteria is added to the work pending list.

Deleting Work Pending Tests

Use this procedure to delete selected tests or all tests from the Work Pending screen.

Go to the Work Pending screen. To get to this screen from any screen, select the Work Pending button.

(Optional) Select the test(s) you want to delete.

Select Delete F6.

The Delete window is displayed with the Current Test option selected. This option will delete only the test currently selected on the Work Pending screen.

(Optional) Select a different option from the Delete What list.

• To delete selected tests, select the Selected Tests option. This option is available only if you selected tests on the Work Pending screen.

• To delete all of the tests that fit the filter criteria, select the All Tests in

Filter option.

Select OK F1.


Select Yes F1.

The system deletes the test(s).

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Printing Work Pending

Use this procedure to print a list of samples associated with pending test requests.

Go to the Work Pending screen. To get to this screen from any screen, select the Work Pending button.

Select Print F7.

The system prints the Work Pending Report (see Figure 4-12).

0824D.bmp

Figure 4-12 Work Pending Report

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123 Lake StreetWork Pending Report Townsville, ST 33333

Access 2 Immunoassay System 101-555-2323 ext. 109

S/N 501240 Jane Smith

Filter: Off-board Reflex, Manual Rerun, LIS tests.Samples Requested: 3LIS Workpool: 2

Sample ID Patient ID Requested Tests Pending Origin (Rack/Instrument)

80140-0055 654321654 10/10/11 11:05:23 AM FOL2 LIS (Unknown)

80140-0055 654321654 10/1011 11:06:07 AM Ferritin LIS (Unknown)

80140-0055 654321654 10/10/11 11:06:58 AM VitB12 LIS (Unknown)

80140-0083 123456123 10/10/11 12:14:26 PM VitB12 Unknown (Unknown)

73124-0421 555666777 10/10/11 12:30:04 PM CK-MB LIS (902 / 501240)

Page 1 of 1Technologist ______________________________________ Printed 10/10/11 11:05 PM

Access 2 Operator’s Guide 4.4: Monitoring Sample Progress

4.4Monitoring Sample Progress

You can monitor sample progress by looking at the rack status, sample status, or test status:

• Rack Status

Progress of all samples on a rack.

• Sample Status

Progress of individual samples.

• Test Status

Progress of requested tests.

Rack Status You can monitor the testing progress of an entire rack by looking at the rack status, displayed on the Sample Manager screen. The system displays the rack status in the center of the rack button in the On Board or Off Board list.

The rack status depends on the progress of each sample in the rack. After the rack reaches the status of Requested, the sample in the earliest stage of testing determines the status. For example, if nine samples in a rack are In Progress but the tenth sample is Requested, the rack status is Requested.

You can use the rack status to determine when you can unload a rack from the instrument. You can unload a rack with the Aspirated status without affecting testing, unless a reflex test is requested after aspiration is complete. If you attempt to unload a rack before the Aspirated status, the system displays a confirmation window before you can unload it.

If a reflex test begins processing, the rack status can revert to an earlier status. For more information about reflex testing, see Chapter 4: System Configuration in the Reference Manual.


4.4: Monitoring Sample Progress Access 2 Operator’s Guide

For more information about the Sample Manager screen, see Chapter 3: Sample Management.

Rack Status Definition

No Tests The rack is empty or has samples associated with it, but none of the samples has requested tests.

Requested At least one test has been entered or downloaded for at least one sample in the rack.

Supply Wait At least one test requested for at least one sample in the rack requires you to load supplies or calibrate assays before it can run.

In Progress All tests requested for all samples in the rack have been scheduled for processing.

The Asp. and Comp. fields replace the rack status. The Asp.

field displays the estimated time until aspiration is complete and the Comp. field displays the estimated time until all processing is complete for the rack.

If the rack is being used for a maintenance routine, the Asp. and Comp. fields are displayed as applicable.

Aspirated All tests requested for all samples in the rack have been pipetted. You can remove the rack without affecting processing, unless a reflex test is requested after aspiration is complete.

The Asp. field displays Done, and the Comp. field displays the estimated time until all processing is complete for the rack.

Done All tests requested for all samples in the rack have been processed. The Done rack status replaces the Asp. and Comp. fields.

*Done* All tests requested for all samples in the rack have been processed, but at least one test was cancelled. The *Done* rack status replaces the Asp. and Comp. fields.

Table 4-13 Rack Status Descriptions for Sample Manager Screen


Access 2 Operator’s Guide 4.4: Monitoring Sample Progress

Sample Status For an individual sample, you can monitor sample progress by looking at the Status column on the Test Requests screen. For more information about the Test Requests screen, see Chapter 3: Sample Management.

Test Status You can monitor individual test status by looking at the Result column on the Test Results screen. During test processing, the system displays the test status instead of a result in this column. For more information about this screen, see Chapter 5: Test Results.

Sample Status Definition

No Tests The sample ID exists, but no tests have been requested or downloaded for the sample.

Requested At least one test has been entered or downloaded for the sample.

Supply Wait At least one test requested for the sample requires you to load supplies or calibrate the assay before it can run.

In Progress All tests requested for the sample have been scheduled.

Aspirated All tests requested for the sample have been pipetted.

Done All tests requested for the sample have been processed.

*Done* All tests requested for the sample have been processed, but at least one test was cancelled.

CLT If the instrument detects an obstruction while attempting to pipette sample, CLT is displayed beneath the sample status.

QNS If the sample quantity (volume) was not sufficient for one or more of the requested tests, QNS is displayed to the right of the sample status.

Table 4-14 Sample Status Descriptions for Test Requests Screen

Test Status Definition

Requested The test has been entered or downloaded.

Supply Wait The test requires supplies or calibration before it can be run. The supply and calibration conditions are listed on the Supplies Required screen.

Table 4-15 Test Status Descriptions for the Test Results Screen


4.4: Monitoring Sample Progress Access 2 Operator’s Guide

In Progress The test is in one of the following states:

• Waiting to be scheduled

• Scheduled for processing

• Pipetted

• Processing is complete, but the result is not yet calculated

Cancelled The test was cancelled before processing was complete. The system did not calculate a result.

Test Status Definition

Table 4-15 Test Status Descriptions for the Test Results Screen


Access 2 Operator’s Guide 5: Test Results


5Test Results

5.1 Test Results ......................................................................................................5-2

Test Results Screen ...........................................................................................5-4

Selecting Test Results .......................................................................................5-7

5.2 Reviewing Test Results ..................................................................................5-9

Test Result Filters .............................................................................................5-9

Applying a Test Result Filter .......................................................................... 5-11

Editing a Test Result Filter ............................................................................. 5-15

Defining a New Test Result Filter .................................................................. 5-19

Deleting a Test Result Filter ........................................................................... 5-20

Specifying a Date and Time Range for a Test Result Filter ........................... 5-20

Finding a Test Result ......................................................................................5-22

Rerunning a Test ............................................................................................. 5-24

Viewing Sample Details.................................................................................. 5-25

Test Result Flags ............................................................................................. 5-27

Configuring the Test Results Screen...............................................................5-28

5.3 Managing Test Results ................................................................................ 5-31

Sending Test Results to the LIS...................................................................... 5-32

Copying Test Results to Disk or USB Flash Drive......................................... 5-36

Deleting a Test Result ..................................................................................... 5-41

5.4 Test Result Reports ....................................................................................... 5-42

Printing Test Result Reports ........................................................................... 5-44

5: Test Results Access 2 Operator’s Guide

5.1Test Results

Test results are data the Access 2 system creates and stores for every test the system runs. As the system completes sample processing, the test results become available for you to review, manage, and print. Test results include:

You can review the test results on the Test Results screen, or print the test results in one of several report formats.

You use the function buttons on the screen to perform these procedures:

For an overview of how to generate test results, see Figure 5-1.

For more information about filters, see Section 5.2: Reviewing Test Results.

• Sample ID • Relative light units (RLUs)

• Test name and replicate number • Flags

• Result (with units) • Rack ID

• LIS status • Instrument that ran the test

• Verify status (for LIS) • Completion date and time

• Patient ID or lot number

• Configure the Test Results screen • Find a specific result

• View sample demographic data and flags (details)

• Rerun tests with flagged results

• Apply a filter to test results • Send results to an LIS

• Delete test results • Copy test results to a disk or USB flash drive


Access 2 Operator’s Guide 5.1: Test Results

0591B.wmf

Figure 5-1 Test Results Flowchart

Prepare samples forprocessing

Run tests

Set up and runcalibrators

View test results

For more information about setting up andrunning calibrators, see Chapter 6: CalibrationData in the Operator's Manual.

For more information about setting up tests, seeChapter 4: Sample Processing in the Operator'sManual.

For more information about running a test, seeChapter 4: Sample Processing in the Operator'sManual.

For more information about viewing test results,see Chapter 5: Test Results in the Operator'sManual.

Set up and run qualitycontrols

For more information about setting up andrunning quality controls, see Chapter 7: QualityControls in the Operator's Manual.


5.1: Test Results Access 2 Operator’s Guide

Test Results ScreenYou use the Test Results screen to:

• Apply a filter to the test results

• Find a specific test result

• Rerun a test

• View sample demographic data and flag descriptions

• Send test results to the LIS

• Copy test results to a disk or USB flash drive

• Print test results

• Configure the Test Results screen

To get to this screen from the Main Menu, select Test Results F2.

0627D.bmp

Figure 5-2 Test Results Screen



Filter (Field) Displays the selected filter and sort order.

The default filter from the Main Menu (on initial entry and after reboot) is All

Samples (Last 30 days) - Sorted by Sample ID Then by Test Name. Each time you change the filter, it becomes the default filter.

Entries (Field) Displays the number of test results that meet the selected filter parameters.

Displays a visual cue (+) when new results have been added since the filter was applied.

Selected Result (Row) Displays an Arrow button at the beginning of the selected row. The selected row is highlighted. If more than one row is selected, all rows are highlighted and the Arrow button is displayed in the last selected row. For more information, see the Selecting Test Results procedure in this section.

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

NOTE

A patient ID is required for LIS test requests.

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

Rack (Optional column) Displays the number of the rack the sample is loaded on.

Test Name (Required column) Displays the test name associated with the result.

Result (Required column) Displays the result of the test, including the value, units, and interpretation. No Value is displayed if the result is associated with a fatal flag, if the result was run using an uncalibrated reagent lot, or if a calibrator result is outside the upper or lower limits of the curve.

If test processing is incomplete, displays the test status. For more information about test status, see Section 4.4: Monitoring Sample Progress.

The system displays the test result in red for the following conditions:

• Quantitative and Semi-Quantitative - For controls, if the results are outside of the control range.

• Qualitative - If the result is reactive, confirmed, or associated with a GRY flag.

Comp. Time (Optional column) Displays the date and completion time of the test.

Flags (Required column) Displays any flags associated with the result. If there are no flags, the field is blank.

Table 5-3 Test Results Screen Descriptions



LIS (Optional column) Displays the LIS status of the test result.

Values are:

• <blank> - Either the system has not calculated the result, or the result will not be sent to the LIS.

• Sending - The system is sending the result to the LIS.

• Accepted - The system sent the result and the LIS received it.

• Failed - The system sent the result, but the LIS did not receive it.

• Idle - The system attempted to send the test result to the LIS while the global LIS interface was offline.

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

Instrument (Optional column - not shown) Displays the ID of the instrument that ran the test.

Verify (Optional column - not shown) Displays the status of the test results. When the LIS is set up to send only auto-verified results to the LIS, the system compares the test results to the LIS ranges you defined. For more information, see Section 4.9: LIS Setup. Also see Section 4.7: Ranges Setup in the Reference Manual. Values are:

• <blank> - The system has not compared the test result to the set LIS ranges. If the column is blank, it usually means the result has not been calculated yet.

• Pass - The test result was within the set LIS ranges. The system sent the result to the LIS.

• Fail - The test result was not within the set LIS ranges and the system cannot send it to the LIS. The system displays the word Fail in red.

• Not Verified - The LIS is not set up to verify results.

Pipettor (Optional column - not shown) Displays N/A. This column is reserved for future use.

Filter F1 (Button) Select to apply, edit, or delete filters and sort orders to the Test Results screen. The system displays the selected filter and sort order in the Filter field.

For information about test result filters, see Section 5.2: Reviewing Test Results.

Find F2 (Button) Select to search the filtered results for a specific test result.

Rerun Test F3 (Button) Select to re-request the selected test. If the sample is on board an instrument, the test is automatically assigned and runs at the next opportunity. If the sample is off board, the system displays it on the Work Pending screen (see Chapter 4: Sample Processing for more information on Work Pending).

Sample Details F4 (Button) Select to display demographic information, comments, and flag interpretations for the sample.

Table 5-3 Test Results Screen Descriptions (continued)



Selecting Test Results

Use this procedure to select one or more test results on the Test Results screen.

Go to the Test Results screen. To get to this screen from the Main Menu, select Test Results F2.

Select a test result by selecting the row. An arrow displays at the beginning of the selected row.

NOTES

• Use the scroll bar on the right side of the screen to view the results that are out of the normal viewing range.

• Press the [Ctrl] key while you press the [Home] or [End] key to go to the beginning or end of the test result list, respectively.

(Optional) Select a different row by touching it. The arrow displays at the new row you selected and is cleared from the previous selection.

Send to LIS F5 (Button) Select to send test results to the LIS.

Copy to Disk F6 (Button) Select to copy all test results or selected test results to a disk or USB flash drive. For more information, see the Copying Test Results to Disk or USB Flash Drive procedure in this section.

Print F7 (Button) Select to display a menu of the following options:

Report F1

Select to print test result reports.

Completed Samples F2

Select to manually print results as samples are completed. The results print on the Continuous Sample Report.

More Options F8 (Button) Select to display a menu of the following options:

Refresh Screen F1

Select to re-apply the filter and display new results that match the filter parameters.

Configure Screen F2

Select to choose optional columns and change column order of the test result data.

Delete Data F3

Select to remove test result data from the system and the database.

Table 5-3 Test Results Screen Descriptions (continued)

1

2



(Optional) To make multiple selections, you use the [Ctrl] or [Shift] key.

To select test results that are not contiguous, press the [Ctrl] key while you select multiple rows. For example, press the [Ctrl] key and then select 3 results. Each of the rows is selected.

To select contiguous test results, press the [Shift] key while you select the first and last of the contiguous rows. For example, to select the first 5 results, press the [Shift] key and then select the first and fifth results. Release the [Shift] key. All five results are selected.

(Optional) To remove one result from multiple selected results, press the [Ctrl] key while you select the middle of the row with the result. The result is no longer selected.


Access 2 Operator’s Guide 5.2: Reviewing Test Results

5.2Reviewing Test Results

When test results become available, you can review them. The system displays test results for all samples currently on board the instrument and sorts them by sample ID, then by test name. This is the default filter the system applies to the test result data. You can limit the number of test results that display on the screen by applying a different filter. You can also choose the columns you want to display and customize the column order.

You can find a specific test result using the sample ID, patient ID, rack ID, or test name.You can also view test result flags and descriptions. Flags are codes the Access 2 system associates with test results when a special circumstance requires attention.

When reviewing results for a particular sample, you can rerun any tests on that sample.

Test Result Filters

A test result filter is a set of parameters you can manipulate to limit the number of results displayed on the Test Results screen to only those you want to see at any given time.

The Test Results screen is always filtered. The default filter from the Main Menu is All Samples (Last 30 Days) - Sorted by Sample ID Then by Test Name.

The system displays the test results based on the filter parameters. You can adjust the number and type of test results displayed by selecting a different system-defined filter, defining a new filter, or editing the parameters of one of your laboratory’s defined filters.

You define a new filter by determining all of the parameters for the filter. For example, you can create a filter that only displays patient samples with a sample ID that begins with the digits 1234.


5.2: Reviewing Test Results Access 2 Operator’s Guide

You can also edit the laboratory-defined filter parameters to display different test results, or you can use a system-defined filter as a basis for creating a new filter. For example, you can select the system-defined All Patient Samples (Last 30 Days)

filter, change the parameters, and save the filter with a new name.

When you change any of the parameters of a filter, you can either save the changes as a new filter or apply the changes without saving them. If you do not save the changes, the system retains the unnamed filter only until you apply a different one. You would have to redefine the filter to use it again.

The last filter you apply becomes the default filter for the next time you display the Test Results screen. The Access 2 system automatically uses that default filter until you apply a new one or until the system is rebooted.

A sort order determines the order test results are listed in, and you can include both primary and secondary sort orders in a filter. For example, you can sort test results by Sample ID, then by Completion Time in ascending order.



0522A.wmf

Figure 5-4 Applying a Test Result Filter Flowchart

Applying a Test Result Filter

Use this procedure to apply one of the available test result filters. The following test result filters are system-defined:

Main Menu

Test ResultsF2

Test Results

FilterF1

Filter

Select filterand sort orders

OKF1

Filter Default 1st Order Default 2nd Order

All Flagged Test Results (Last 30 Days)

Sample ID Test Name

All Patient Samples (Last 30 Days)

Sample ID Test Name

All Patient Samples Loaded Between...

Completion Time

All Samples (Last 30 Days) Sample ID Test Name

All Samples Loaded Between...

Completion Time

Table 5-5 Filters and Default Sort Orders



Go to the Filter window. To get to this window from the Main Menu, select Test Results F2 to display the Test Results screen, then select Filter F1.

2037A.bmp

Figure 5-6 Filter (Test Results) Window

Failed Auto-Verify and Not Sent to LIS

Sample ID Test Name

LIS Transmission Failed Sample ID Test Name

On-board Patient Samples Sample ID Test Name

On-board Samples Sample ID Test Name

On-board STAT Samples Sample ID Test Name

Filter Default 1st Order Default 2nd Order

Table 5-5 Filters and Default Sort Orders (continued)

1

Filter (List) Displays a list of available filters.

1st Sort Order (Option) Select to change the primary sort order. The sort order default is dependent on the filter (see Table 5-5).

Values are: Sample ID, Patient ID, Test Name, Rack ID, Completion Time.

Table 5-7 Filter (Test Results) Window Descriptions



Select a filter from the list.

The system displays a description of the filter in the Description field.

(Optional) To change the sort order, select a 1st and 2nd Sort Order option.

(Optional) To display the results in descending order, clear the Ascending box.

Select OK F1.

NOTE

If you selected the system-defined filters All Patient Samples Loaded

Between... or All Samples Loaded Between..., or a laboratory-defined filter that asks for the date and time, the system prompts you to enter the date range. For more information, see the Specifying a Date and Time Range for a Test Result Filter procedure in this section.

The system displays all test results that meet the selected filter parameters on the Test Results screen. The applied filter becomes the default filter until you apply a different saved filter.

2nd Sort Order (Option) Select to change the secondary sort order. The sort order default is dependent on the filter (see Table 5-5).

Values are: No second sort, Sample ID, Patient ID, Test Name, Rack ID, and Completion Time.

Ascending (Box) Select to sort the results in ascending, alphabetic order or clear to sort in descending, alphabetic order.

Description (Field) Displays a description of the selected filter.

New Filter F2 (Button) Select to display the New Filter window and define a new filter.

Edit Filter F3 (Button) Select to display the Edit Filter window. The fields and options in the Edit Filter window reflect the selected filter parameters. In this window, you can edit the existing filter parameters and save the changes as a new filter or apply the new filter without saving it.

Delete Filter F4 (Button) Select to delete the filter selected in the Filter list box.

NOTE

You cannot delete a system-defined filter.

Table 5-7 Filter (Test Results) Window Descriptions (continued)

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3



0647B.wmf

Figure 5-8 Editing a Test Result Filter Flowchart

Main Menu

Test ResultsF2

Test Results

FilterF1

OKF1

Edit filter parameters

Edit Filter

Filter

Select filterand sort orders

Edit FilterF3

Clear ParametersF3

Filter ParametersFilter NameDescriptionAsk for Date & TimeInstrumentsTest Result StatusLIS StateSample IDTest NameAuto-VerifyRack IDPatient IDResultPopulation

Filterparameters

OK?

Yes

No

NoF4

Save Filter?

Give the filter a name

OKF1

System applies filter,but does not save it

YesF1

Yes

No CancelF8

System does not applyor save the filter

No



Editing a Test Result Filter

Use this procedure to edit an existing filter and apply it to the Test Results screen.

NOTE

If you change the system ID for an instrument in your workgroup, the instruments selected in the existing filters may also change. Test and update the filters to make sure they operate as expected.


Select the filter you want to edit from the Filter list.

The system displays a description of the filter in the Description field and the default sort orders in the 1st and 2nd Sort Order columns.

(Optional) Select new Sort Order options.

Select Edit Filter F3.

The Edit Filter window is displayed.

The fields and options in the Edit Filter window reflect the selected filter parameters. You can change as many or as few of the filter parameters as you want.

0605B.bmp

Figure 5-9 Edit Filter (Test Results) Window

1

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3



Filter Name (Field) Displays the name of the filter selected in the Filter window. You can delete the name and type a new name.

Description (Field) Displays the description of the filter selected in the Filter window. You can delete the description and type a new description.

Ask for Date and Time

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

To set the date and time, see the Specifying a Date and Time Range for a Test Result Filter procedure in this section.

Instruments (Boxes) Select the instrument(s) to include in the filter.

If your Access 2 system is connected to a workgroup, there could be up to 4 systems to choose from.

Test Result Status (Boxes) Select the test result statuses to include in the filter. Values are:

• Completed

• Not Completed

• On Board

• Off Board

• STAT

• Routine

• Flagged

• Not Flagged

LIS State (List) Select to include the status of the LIS in your filter. Values are:

• All

• Idle

• Sending

• Failed

• Accepted

• Not Sent

Sample ID (List) Select the sample IDs to include in the filter. In the first field, select a relationship from the list.

Values are: all, =, <, >, <=, >=.

In the second field, enter a sample ID value.

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

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

Values are: Pass, Fail, Not Verified, or All results.

Table 5-10 Edit Filter (Test Results) Window Descriptions



Enter the information and select or clear boxes and options to define the parameters for the filter.

Select OK F1.

The system prompts you to save the filter.

(Optional) To save your changes to a system-defined filter, select Yes F1 to display the Save As window. Enter a name for the filter in the Save Filter As field, then select OK F1.

NOTE

If you are editing one of the system-defined filters, you must save it as a different name.

(Optional) To continue without saving changes to the filter, select No F4. The system applies the filter.

(Optional) To continue without saving the filter, select Cancel F8. The system does not save or apply the filter.

Rack ID (List) Select the rack IDs to include in the filter. The list contains all racks defined in the database.

Patient ID (List) Select the patient IDs to include in the filter. In the first field, select a relationship.

Values are: all, =, Begins With, Ends With, Contains.

In the second field, enter a patient ID value.

Result (List) Select to enter a numeric relationship to filter results. For example, if you set the value in the first box to >, and the value in the next box is 4.00, then the filter locates results > 4.00.

Values for the first box are all, +, <, >, <=, >=, outside of, and between.

Population (Boxes) Select the result population to include in the filter.

Values are: Patients, Controls, Calibrators.

Save As F2 (Button) Select to save the new or edited filter with a new name. For laboratory-defined filters, you can keep the same name and overwrite the previous filter. When you save the filter, it is applied.

Clear Parameters F3

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

Table 5-10 Edit Filter (Test Results) Window Descriptions (continued)

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5



0610B.wmf

Figure 5-11 Defining a New Test Result Filter Flowchart

Main Menu

Test ResultsF2

Test Results

FilterF1

OKF1

Enter filter parameters

New Filter

Filter

New FilterF2

Clear ParametersF3

Filter ParametersFilter NameDescriptionAsk for Date & TimeInstrumentsLIS StateTest Result StatusSample IDTest NameAuto-VerifyRack IDPatient IDResultPopulationNew filter

parametersOK?

Yes

No

NoF4 Save Filter?

Give the filter a name

OKF1

System applies filter,but does not save it

YesF1

No

Yes



Defining a New Test Result Filter

Use this procedure to define a new filter and apply it to the Test Results screen.

Go to the New Filter window. To get to this window from the Main Menu, select Test Results F2 to display the Test Results screen, then

Select Filter F1 to display the Filter window, then

Select New Filter F2.

The New and Edit Filter windows are the same, but the fields in the New Filter window are blank.

Enter information and select or clear the boxes and options to define the parameters for the new filter.

NOTE

Every new filter has the default sort orders Sample ID and Test Name.

(Optional) To change the sort orders, select OK F1 and select new sort order options.

In the Filter window, select OK F1.

The system prompts you to save the filter.

(Optional) To save and apply the filter, select Yes F1 to display the Save As window. Enter a name for the filter in the Save Filter As field, then select OK F1.

If the filter requires a date or time range, the Specify a Date Range window is displayed. Select the appropriate ranges or enter information in the fields, then select OK F1. For more information, see the Specifying a Date and Time Range for a Test Result Filter procedure in this section.

The system displays the test results that meet the filter parameters on the Test Results screen.

(Optional) To apply a filter without saving it, select No F4. The unnamed filter remains the default filter until you apply a different one.

The system displays the test results that meet the filter parameters on the Test Results screen.

1

2

3



Deleting a Test Result Filter

Use this procedure to delete any new or edited filters. You cannot delete system-defined filters.


In the Filter list, select the filter you want to delete.

Select Delete Filter F4. This button is unavailable for system-defined filters.

The system displays a confirmation message.

Select OK F1 to delete the filter.

Select Cancel F8 to exit the Filter window without changing the applied filter.

Specifying a Date and Time Range for a Test Result Filter

Use this procedure to specify date and time parameters when applying a test result filter that asks for date and time ranges.


Select a filter that requires you to specify a date and time range (the Ask for

Date and Time box was selected when the filter was defined).

Select OK F1. The Specify a Date Range window is displayed.

0927B.bmp

Figure 5-12 Specify a Date Range (Test Results Filter) Window

1

2

3

4

5

1

2

3



Select a Date and Time Range option, or select the Date and Time Range option.

If you select the Date and Time Range option, enter the starting and ending dates and the starting and ending times in the appropriate fields.

NOTE

The date format follows the format you set up on the System Setup screen. The system displays a message if the incorrect format is used. For more information about setting the date format, see Chapter 4: System Configuration in the Reference Manual.

Select OK F1 to apply the filter.

Date and Time Range

(Options and field) Select one of the following options to display the test results from that date range:

• Past 24 hours - display all of the test results that were obtained in the past 24 hours and fit the filter criteria

• Past 7 days - display all of the test results that were obtained in the past 7 days and fit the filter criteria

• Past # days - display all of the test results that were obtained during the days you enter and that fit the filter criteria

• Past # hours - display all of the test results that were obtained in the past number of hours you enter and that fit the filter criteria

If you select one of the options with a # sign, enter a number in the field below the options.

Specify Date and Time Range

(Option and fields) Select the Date and Time Range option and specify the starting and ending dates and times.

Table 5-13 Specify a Date Range (Test Results Filter) Window Descriptions

4

5



0520B.wmf

Figure 5-14 Finding a Test Result Flowchart

Finding a Test Result

Use this procedure to search filtered results for a specific test result.

NOTE

This procedure will only find test results that fit the filter criteria. If you are having difficulty finding a specific test result, apply a different new filter.


Select Find F2.

The Find window is displayed.

FindF2

Main Menu

Test ResultsF2

Find

Enter one of thefollowing: Sample ID,

Patient ID, Rack ID, orTest Name

(Optional)Select a search

direction, up or down

Result(s)selected?

Yes

Find NextF1

CancelF8

No

1

2



0609A.bmp

Figure 5-15 Find (Test Result) Window

Enter information in one of the Sample ID, Patient ID, Rack ID, or Test Name fields for the sample you want to find.

(Optional) To change the direction of the search, select the Up or Down option.

Select Find Next F1. The closest match to the search parameters you entered becomes the selected result.

NOTES

• If the system does not find a match, the system displays a message in the status line.

• If any of the filtered results have been deleted, a message displays that directs you to refresh the screen. To refresh the screen, select More Options F8 and then select Refresh Screen F1. Repeat step 4.

Sample ID (Field) Enter the sample ID of the result you want to find.

You do not need to enter complete information in the field. For example, if you are searching for sample ID 123456789, enter 1234. The system will select the first sample ID starting with 1234.

Rack ID (List and Field) Select from a list of known rack IDs or enter a rack ID.

Patient ID (Field) Enter the patient ID.

Test Name (List and Field) Select from a list of test names or enter a test name.

Direction (Option) Select Up or Down to change the direction of the search. If you select Down, the system begins the search at the current result and continues down the list. If you select Up, the system begins the search at the current result and continues up the list.

When a search reaches the top or bottom of the list, the search continues from the opposite end.

Find Next F1 (Button) Select to find the next result included in the filter that fits the search criteria.

Table 5-16 Find (Test Result) Window Descriptions

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4



(Optional) To find the next result that fits the search criteria, select Find Next F1.

Select Cancel F8 to exit the window.

Rerunning a Test

Use this procedure to rerun a test. If the sample is on board an instrument, the system automatically assigns the test and runs it at the next opportunity. If the sample is off board, the system assigns it to the instrument and displays it on the Work Pending screen (see Chapter 4: Sample Processing in this manual).

NOTE

You can only rerun tests for patient and quality control samples. To rerun tests for other kinds of samples, request the tests again.


(Optional) To locate a specific test result associated with the sample, select Find F2. For information about how to do this, see the Finding a Test Result procedure in this section.

Select the test you want to rerun.

Select Rerun Test F3.

The system displays a warning message.

Select OK F1 to complete the request and exit the window.

5

1

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3

4



0643B.wmf

Figure 5-17 Viewing Sample Details Flowchart

Viewing Sample Details

Use this procedure to view details about the sample the result is associated with, including demographic information, comments, and result flag explanations (if applicable).


(Optional) To find a specific test result, select Find F2. For information about how to do this, see the Finding a Test Result procedure in this section.

Select a single test result.

Select Sample Details F4 to display the Sample Details window.

Sample DetailsF4

Main Menu

Test ResultsF2

Details

Review sampledemographic

information and flagexplanations (if any)

(Optional) To find aspecific test result,

select Find F2.

For more information about finding test results,see the Finding a Test Result procedure in thissection.

Select a singletest result

OKF1

1

2

3



0747C.bmp

Figure 5-18 Sample Details Window

Patient ID (Field) Displays the patient ID, if one exists, for the patient sample. This demographic information is sent from the LIS.

First Name (Field) Displays the first name of the patient that is associated with the sample. This demographic information is sent from the LIS.

Last Name (Field) Displays the last name of the patient that is associated with the sample. This demographic information is sent from the LIS.

Sex (Field) Displays the sex of the patient that is associated with the sample. This demographic information is sent from the LIS.

Birth Date (Field) Displays the birth date of the patient that is associated with the sample. This demographic information is sent from the LIS.

Doctor Name (Field) Displays the doctor’s name that is associated with the patient sample. This demographic information is sent from the LIS.

Table 5-19 Sample Details Window Descriptions



Select OK F1.

Test Result Flags

If something occurs while a test is running or if the system needs supplies, the system associates a flag to the sample.

You can use the Sample Details window to read a description of the flags associated with a particular result. You then select Troubleshoot F2 to find troubleshooting information about each flag.

For the result flag description and troubleshooting information, see Section A.4: Assay Troubleshooting in the Reference Manual.

Sample ID (Field) Displays the sample ID of the patient sample.

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

Dilution (Field) Displays the dilution factor of the patient sample.

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

Reference Range (Field) Displays the reference range used for the test. The reference range is defined in the ranges windows (see Section 4.7: Ranges Setup in the Reference

Manual).

Result (Field) Displays the results of the test run on the sample.

Sample Comment (Field) Displays any comments entered about the sample.

Flags (List) Displays the flags applied to the result and a description of each flag.

Troubleshoot F2 (Button) Displays troubleshooting Help about flags.

NOTE

This button is unavailable for results without flags.

Table 5-19 Sample Details Window Descriptions (continued)

4



0611B.wmf

Figure 5-20 Configuring the Test Results Screen Flowchart

Configuring the Test Results Screen

Use this procedure to change the columns and rearrange the order of the columns displayed on the Test Results screen. The system displays the following default columns for all filters except for the Failed Auto-Verify and Not Sent to LIS filter:

For the Failed Auto-Verify and Not Sent to LIS filter, the system displays the Verify column and does not display the Patient ID column. You can change the default column configurations for any filter.

Configure Screen

Select optional columnsand column order

for display

Main Menu

Test ResultsF2

Test Results

More OptionsF8

Configure ScreenF2

OKF1

• Patient ID • Result

• Sample ID • Completion Time

• Rack • Flags

• Test Name • LIS



Go to the Configure Screen window. To get to this window from the Main Menu, select Test Results F2 to display the Test Results screen, then

Select More Options F8, then

Select Configure Screen F2.

The Configure Screen window displays the columns as they appear on the Test Results screen. There are four required columns: Sample ID, Test Name, Result, and Flags. You can change the order of the required columns, but you cannot remove them from the Test Results screen.

0602A.bmp

Figure 5-21 Configure Screen (Test Results) Window

1

Column Order Buttons

Column Order (Row) Displays the columns currently included on the Test Results screen and in their respective order.

Optional Columns (Boxes) Select the optional columns to include on the Test Results screen.

Values are: Patient ID, Rack, Verify, Comp. Time, LIS, Instrument, RLU and Pipettor.

For more information about these values, see Table 5-3.

Column Order Buttons

(Buttons) Select the right or left arrow button to rearrange the columns in the Column Order row.

You can select a column from the Column Order row before selecting an arrow button to move that column right or left. If you do not select a column, before selecting an arrow button, the first column is selected by default.

Table 5-22 Configure Screen (Test Results) Window Descriptions



In the Optional Columns list, select the additional columns you want to include from the following column options: Patient ID, Rack, Verify, Comp. Time,

LIS, Instrument, RLU, Pipettor.

You can add optional columns, depending on the combination of columns, until you reach the maximum width of the screen.

(Optional) To rearrange the order of the columns, select a column and use the right and left arrow column buttons to move it.

Select OK F1.

The Test Results screen displays the new options you selected.

2

3


Access 2 Operator’s Guide 5.3: Managing Test Results

5.3Managing Test Results

For help in managing your test results, you can use the Access 2 system to:

• Send test results to the LIS

• Copy test results

• Delete test results

If you are using an LIS, the system automatically sends the test results with their associated flags to the LIS when sample processing is complete.

NOTES

• Tests results with fatal flags are not sent to the LIS automatically nor can they be sent manually.

• For a list of circumstances that require you to manually send test results to the LIS, see the Sending Test Results to the LIS procedure in this section.

You can copy selected test results or all test results to a high-density, 3.5-inch DOS-formatted disk or a USB flash drive.

NOTE

USB flash drive technology became available with software version 3.0 and higher, and is not compatible with all Access 2 systems.

Copying test results does not remove them from the system database.

Deleting test results removes the data permanently from the system database.

For information about how to automatically transmit test results to the LIS and how to enable host query of the LIS, see Chapter 4: System Configuration in the Reference

Manual.


5.3: Managing Test Results Access 2 Operator’s Guide

0644A.wmf

Figure 5-23 Sending Test Results to the LIS Flowchart

Sending Test Results to the LIS

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

• The Auto Send to LIS option is set to Off or to Send Only Auto-Verified

Results. For more information about the Auto Send to LIS or Send Only

Auto-Verified Results options, see Section 4.9: LIS Setup in the Reference

Manual.

• The LIS fails to receive a transmission of test results.

• The test results were on hold while the LIS was off-line, and now it is back on-line.

Selectedresults

displayed?No

Yes

FilterF1

(Optional)Select a group of

results or a single result

Send to LISF5

Main Menu

Test Results

OKF1

Filter

Apply filterand sort orders

Test ResultsF2

Send to LIS

Select Current Result,Current Selection,

Resend LIS Fail, or All (filtered results)




(Optional) To locate a group of test results to send to the LIS, apply a filter to reduce the number of displayed results. For information about how to do this, see the Applying a Test Result Filter procedure in Section 5.2: Reviewing Test Results.

(Optional) To locate a specific test result to send, select Find F2. For information about how to do this, see the Finding a Test Result procedure in Section 5.2: Reviewing Test Results.

Select a single test result or a group of results to send the LIS. For more information about selecting test results, see the Selecting Test Results procedure in Section 5.1: Test Results.

Select Send to LIS F5.

The Send to LIS window is displayed.

0626A.bmp

Figure 5-24 Send to LIS Window

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

Current Selection

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

Resend LIS Fail

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

All (filtered results)

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

Table 5-25 Send to LIS Window Descriptions

1

2

3



Select an option from the Send what list (based on your selection in step 2).

Select OK F1.

NOTE

If any of the filtered results have been deleted, a message displays that directs you to refresh the screen. To refresh the screen, select More Options F8 and then select Refresh Screen F1. Then repeat this procedure, beginning at step 2.

Monitor the transmission by viewing the statuses in the LIS column of the Test Results screen.

• If the LIS successfully receives results, the LIS status changes to Accepted.

• If the LIS does not successfully receive the results, the LIS status changes to Failed.

4

5

6



0645C.wmf

Figure 5-26 Copying Test Results to a Disk or USB Flash Drive Flowchart

Correct set of results selected?

No

Yes

FilterF1

(Optional)Select a group of

results or a single result

Copy to DiskF6

Main Menu

Test ResultsF2

Test Results

Copy to Disk

• Confirm or change the file name

• Select a Copy What option

OKF1

(Optional)Select Format disk

Insert a 3.5" disk into the disk drive or a

USB flash drive into the USB port

Filter


For more information about selecting test results, see the Selecting Test Results procedure in Section 5.1.

For 3.5-inch disks?

Yes

NoFor USB flash drives, select a drive from the

Drive list



Copying Test Results to Disk or USB Flash Drive

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

NOTE


The Access 2 system writes the following data into a comma-separated field format that you can import into a PC-based spreadsheet program:

NOTE

Copying test result data does not remove it from the database.

Be sure the system is in the Ready or Not Ready mode, then go to the Test Results screen. To get to this screen from the Main Menu, select Test Results F2.

(Optional) To locate a group of test results to copy, apply a filter to limit the number of results to include only the results you want to copy. For information about how to do this, see the Applying a Test Result Filter procedure in Section 5.2: Reviewing Test Results.

(Optional) To locate a specific test result to copy, select Find F2. For information about how to do this, see the Finding a Test Result procedure in Section 5.2: Reviewing Test Results.

Select a single test result or a group of results. For more information about selecting test results, see the Selecting Test Results procedure in Section 5.1: Test Results.

• Patient ID • Comp. time • Reag. pack lot number

• Sample ID • Flags • Reag. pack serial number

• Rack • LIS • Predilution factor

• Verify • Instrument • Test ID

• Test name • RLU • Calibrator levels

• Interpretation • Pipettor • Sample comments

• Result • Sample type • Sample load date/time

• Units • Sample priority

1

2



Insert the disk or flash drive into the PC.

• To copy data to a 3.5-inch disk, insert a disk into the 3.5-inch disk drive of the PC.

NOTE

Be sure you insert the disk into the 3.5-inch disk drive of the PC, not the Access 2 instrument.

• To copy data to a USB flash drive, insert a flash drive into a port on the front of the PC. If the front of the PC does not contain a USB port, use a port on the back of the PC.

NOTE

For instruments set up to perform system backups using a USB flash drive, the backup drive might already be in one of the USB ports on the back of the PC. Use a different flash drive to copy data. Do not disturb the flash drive used for backups when inserting and removing the flash drive for copying data.

Select Copy to Disk F6.

The Copy to Disk window is displayed.

2107B.bmp

Figure 5-27 Copy to Disk (Test Results) Window

File name (Field) Displays the default file name and extension of the test result to be copied. You can delete the name and type a new name.

Table 5-28 Copy to Disk (Test Results) Window Descriptions

3

4



Enter a name and file extension for the data file in the File Name field.

• The system supplies a default file name based on the date and time and a .csv (comma delimited) extension.

• If the file name already exists, the system displays a warning message. To overwrite the existing file, select Yes F1. To rename the new file, select Cancel F8.

(Optional) If your instrument has USB flash drive technology, confirm that the correct drive is selected from the Drive list, or select a different drive.

NOTE

Unless directed by Technical Support, do not copy data to the C: Console PC

drive or any drive labeled BACKUPDRIVE.

Select an option from the Copy what list.

(Optional) If the 3.5-inch disk is not formatted, select the Format disk box.

Select OK F1. A progress window is displayed.

• To stop the copy process at any time, select Cancel F8.

If the disk or flash drive becomes full before the copy process is complete, the system displays a status message.

• For a 3.5-inch disk:

- Remove the disk from the drive. Label it with the data file name(s).

- Insert a new disk and select OK F1.

The system automatically names the file on the new disk the same as the file on the first disk, only with the disk number on the end. For example, mydata.csv = disk 1 and mydata(2).csv = disk 2.

Drive (List) For a USB flash drive, select the external computer drive to which data should be copied.

Current Result (Option) Select to copy the selected test result.

Current Selection

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


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

Format disk (Box) Select to format a 3.5-inch high density disk. Formatting a disk prepares it for reading and writing data.

Table 5-28 Copy to Disk (Test Results) Window Descriptions

5

6

7

8



• For a USB flash drive, clear sufficient space on the drive, or copy the files to a different flash drive.

When the copy process is complete, the system displays a status message.

Remove the disk or flash drive from the PC and label it.

NOTE

If you will be using one disk or flash drive to copy multiple files, you can leave it in place for the next copy operation. Be sure to keep track of the file names so you can correctly label the disk or flash drive when you remove it.

9

10



0646B.wmf

Figure 5-29 Deleting a Test Result Flowchart

Correct resultsdisplayed? No

Yes

FilterF1

Main Menu

Test ResultsF2

Test Results

OKF1

Filter

Apply a filterand sort order

Delete Data

Select option fromDelete What list

More OptionsF8

Delete DataF3

FindF2

No

Enter one of the fouroptions

Find

Password

Enter yourpassword

OKF1



Deleting a Test Result

Use this procedure to permanently delete test results from the database. You need the system password in order to delete test results.

CAUTION

Deleting test results removes the data permanently from the database.

Be sure the system is in the Ready or Not Ready mode, then go to the Test Results screen. To get to this screen from the Main Menu, select Test Results F2.

(Optional) To locate a group of test results to delete, apply a filter to limit the number of results displayed. For information about how to do this, see the Applying a Test Result Filter procedure in Section 5.2: Reviewing Test Results.

(Optional) To locate a specific test result to delete, select Find F2. For information about how to do this, see the Finding a Test Result procedure in Section 5.2: Reviewing Test Results.

Select a single test result or a group of results to delete. For more information about selecting test results, see the Selecting Test Results procedure in Section 5.1: Test Results.

Select More Options F8, then select Delete Data F3.

The Password window is displayed.

In the Password field, enter the system password, then select OK F1.

For information about passwords, see Chapter 4: System Configuration in the Reference Manual.

The Delete Data window is displayed.

Select an option from the Delete what list.

• To delete a single test result, select the Current Result option.

• To delete a group of test results, select the Selected Results option.

• To delete all filtered test results, select the All (filtered results) option.

Select OK F1.

The system displays a warning message.

Select Yes F1 to delete the selected results or Cancel F8 to stop without deleting the results.

A progress window is displayed. The system deletes the test results from the system database. Select Cancel F8 to stop the delete process at any time.

1

2

3

4

5

6

7


5.4: Test Result Reports Access 2 Operator’s Guide

5.4Test Result Reports

You can print test result data in report format. You can print reports manually, or use the auto-print option on the Report Setup window to print STAT and continuous sample reports automatically.

You can display and print the following test result reports:

Report Description

Sample Report Select to print test result information associated with a particular sample.

You can only print one Sample Report at a time.

STAT samples can be set up to automatically print out in a Sample Report format when processing is complete.

Patient Report Select to print test result information associated with a particular patient, identified by the Patient ID.

Selected Test Results Report

Select to print all selected test results.

This report mirrors the configuration of the Test Results screen.

Table 5-30 Types of Test Result Reports


Access 2 Operator’s Guide 5.4: Test Result Reports

For information about how to apply a filter to test results you want to print, see the Applying a Test Result Filter procedure in Section 5.2: Reviewing Test Results.

For information about how to automatically print test result reports, see Chapter 4: System Configuration in the Reference Manual.

Continuous Sample Report

To print this report, set up the automatic print option. This report prints automatically when there are enough test results to fill a page, or when the run is complete. Alternatively, you can manually print the report as samples are completed.

This report includes test results for all of the samples associated with a particular run. The report displays the results on the page continuously when they are completed.

Calibration and maintenance routine results are not included on this report.

Report Description

Table 5-30 Types of Test Result Reports (continued)



0519C.wmf

Figure 5-31 Printing Test Result Reports Flowchart

Printing Test Result Reports

Use this procedure to print a test result report.

NOTES

• If you print the Sample Report, the Patient Report, or the Selected Test Results Report before the final results are calculated for a test, the test status may print in the Result column of the report. For descriptions of the test statuses, see the Test Status procedure in Section 4.4: Monitoring Sample Progress.

1. Select a report from the Reports field2. Select an option from the Print What list

Main Menu

Test ResultsF2

Is correctsample(s)displayed?

Yes

PrintF7

(Optional)Select a group ofdisplayed results

Test Results

Print

OKF1

Are youprinting froma completed

run?

Yes

ReportF1

FilterF1

Filter


PrintF7

Completed SamplesF2

I sContinuous

Sample Reportset toprint?

Yes

Set up the Auto Printoption

System ConfigurationFor information about how toautomatically print test resultreports, see Chapter 4: SystemConfiguration in the ReferenceManual.

NoNoNo

NoNo



• The Continuous Sample Report only prints if you set up the Auto Print option. If set to print, the report prints automatically when there are enough test results to fill a page, when a STAT sample is complete, or when the run is complete. To manually print the report for completed samples, use this procedure. For information about how to set the Auto Print option, see Section 4.2: System Setup in the Reference Manual.

• Demographic information including patient name, birth date, sex, and doctor’s name can be changed from the LIS following the completion of a test result. If the demographic information is changed after a Patient Report is printed, a reprint of the report will contain the updated information.

• Results are displayed in bold text for the following conditions:

- Quantitative and Semi-Quantitative - For quality controls, if the results are outside of the control range. For patient results, if the results are positive, equivalent, reactive, outside of the reference range, or outside either end of the calibration curve.

- Qualitative - If the results are reactive, confirmed, or associated with a GRY flag.

• If information for a sample or patient continues on the next page, the sample or patient ID prints at the top of the next page.

Go to the Test Results screen. To get to this screen from the Main Menu, select Test Results F2. Then continue according to one of the following options:

• To print the Continuous Sample Report, proceed to step 3.

• To print a different result report, proceed to step 2.

Select a single test result or a group of test results that you want to print. For more information about selecting test results, see the Selecting Test Results procedure in Section 5.1: Test Results.

(Optional) To limit the number of results, you can apply a filter. For information about filters, see the Applying a Test Result Filter procedure in Section 5.2: Reviewing Test Results.

(Optional) To locate a specific test result, select Find F2. For information about how to do this, see the Finding a Test Result procedure in Section 5.2: Reviewing Test Results.

Select Print F7.

Select one of the following Print menu options:

• To print the Continuous Sample Report, select Completed Samples F2. The system sends the report to the printer. Results printed manually will not

1

2

3

4



appear on the report that prints automatically at the end of the run. For this option, the procedure ends here.

• To select a result report to print, select Report F1. Then proceed to step 5.

0623B.bmp

Figure 5-32 Print (Test Result Reports) Window

Select the type of report you want to print from the report list (see Table 5-30).

Select the appropriate option from the Print What list (based on your selection in step 2).

Select OK F1.

The system sends the report to the printer. A progress window is displayed. Select Cancel F8 to stop the print job at any time.

Report (List) Select a report to print.

Current Result (Option) Select to print a report for the selected test result.

Current Selection

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


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

Table 5-33 Print (Test Result Reports) Descriptions

5

6

7



0660E.bmp

Figure 5-34 Patient Report


123 Lake StreetTownsville, ST 33333

Patient Report 101-555-2323 ext. 109Access 2 Immunoassay System R. Goldman

Patient ID: 555-56-9898Name: Feldmann, A.Sex: MaleBirth Date: 10-15-1944

**STAT**Sample ID: 23345128Dil Sample Type: Plasma Dilution: 10Test Name Result Ref. Range Flags Completed CK-MB 939.0 ng/mL 0.000 - 4.000 10-10-10 08:18 PMComments: Sample slightly cloudy.

**STAT**Sample ID: 23345128 Sample Type: PlasmaTest Name Result Ref. Range Flags Completed CK-MB >293 ng/mL 0.000 - 4.000 OVR 10-10-10 07:30 PMMYO(2) No Value 17.400-105.700 QNS 10-10-10 07:27 PMMYO 60.04 ng/mL 17.400-105.700 10-10-10 07:27 PM

Sample ID: 423005160 Sample Type: SerumTest Name Result Ref. Range Flags Completed FreePSA% 16.6 10-08-10 02:45 PMfreePSA 1.58 ng/mL 10-08-10 02:45 PMPSA-Hyb 9.53 ng/mL 0.000 - 4.000 10-08-10 02:15 PMComments: Copy of results to Dr Bennett.

Sample ID: 423000204 Sample Type: SerumTest Name Result Ref. Range Flags Completed PSA-Hyb(2) 3.71 ng/mL 0.000 - 4.000 10-02-10 12:03 PMPSA-Hyb 3.86 ng/mL 0.000 - 4.000 10-02-10 11:15 AM

OVR = Over range QNS = Insufficient SamplePage 1 of 1

Technologist ____________________________________ Printed 10-10-10 10:25 PM



0748E.bmp

Figure 5-35 Sample Report


123 Lake StreetTownsville, ST 33333

Sample Report 101-555-2323 ext. 109Access 2 Immunoassay System B. Beaulieu

Sample ID: 23345128 Sample Type: SerumPatient ID: 555-56-9898Name: Follett F.Sex: MaleBirth date: 10-15-1944

**STAT**Instrument: 501240Test Name Result Ref. Range Flags Dilution CompletedCK-MB >293 ng/mL 0.000 - 4.000 OVR 1 10-10-10 07:30 PMMYO(2) No Value 17.400-105.700 QNS 1 10-10-10 07:27 PMMYO 60.04 ng/mL 17.400-105.700 1 10-10-10 07:16 PM

Instrument: 500135Test Name Result Ref. Range Flags Dilution CompletedFreePSA% 16.6 1 10-08-10 02:45 PMfreePSA 1.58 ng/mL 1 10-08-10 02:45 PMPSA-Hyb 9.53 ng/mL 0.000 - 4.000 1 10-08-10 02:15 PMComments: Cloudy sample.

OVR = Over range QNS = Insufficient SamplePage 1 of 1

Technologist _____________________________________ Printed 10-10-10 10:28 PM



0749D.bmp

Figure 5-36 Selected Test Results Report


123 Lake StreetSelected Test Results Report Townsville, ST 33333Access 2 Immunoassay System 101-555-2323 ext 109S/N 501240 V. Flores

Filter: All Samples - Sorted by Sample ID Then by Test Name

Sample ID Rack Test Name Result Flags LIS Comp. Time13501350 48 Ferritin 404.1 ng/mL Accepted 10/10/10 06:4013501350 48 FOL2 4.34 ng/mL Accepted 10/10/10 06:3213501350 48 VitB12 354 pg/mL Accepted 10/10/10 06:3819953581 504 freePSA Supply Wait19953581 504 PSA-Hyb Supply Wait23345128 106 CK-MB >293 ng/mL OVR Accepted 10/10/10 19:3023345128 106 MYO 60.04 ng/mL Accepted 10/10/10 19:2723345128 106 MYO(2) No Value QNS Accepted 10/10/10 19:2725688888 48 VitB12 103 pg/mL Failed 10/10/10 06:4178910116 502 FOL2 Cancelled SYS 10/10/10 10:46

OVR = Over range, QNS = Insufficient sample, SYS = System errorPage 1 of 1

Technologist ________________________________ Printed 10/10/10 20:07



5-50 2014 Beckman Coulter, Inc.

0661E.bmp

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Access 2 Operator’s Guide 6: Assay Calibrations

6Assay Calibrations

6.1 Assay Calibrations.........................................................................................6-2

Calibration Screen.............................................................................................6-4

Applying a Calibration Filter ............................................................................6-6

Deleting Calibrations ........................................................................................6-7

6.2 Reviewing Calibration Data ........................................................................6-8

Stored Calibration Data.....................................................................................6-9

Calibration Data Screens................................................................................. 6-10

Calibration Failure Codes ...............................................................................6-14

Viewing Calibration Curves and Cutoffs........................................................ 6-15

Switching the Active with the Previous Active Calibration ........................... 6-16

Adding a Calibration Comment ...................................................................... 6-16

6.3 Calibration Reports......................................................................................6-17

Printing a Calibration Report .......................................................................... 6-18

6.4 Setting Up Calibrators ................................................................................. 6-22

Calibrator Setup Screen .................................................................................. 6-23

Adding a Calibrator......................................................................................... 6-26

Editing a Calibrator ......................................................................................... 6-27

Deleting a Calibrator ....................................................................................... 6-28


6.1: Assay Calibrations Access 2 Operator’s Guide

6.1Assay Calibrations

You periodically calibrate assays on an Access 2 instrument to establish values that the system uses to correctly report test results for patient and quality control samples on that instrument. There are three types of assay calibrations. The calibrations differ in the way they calculate and report test results.

• Quantitative assay calibrations establish a calibration curve that the system uses to convert sample RLU (relative light unit) readings into concentrations.

• Semi-quantitative assay calibrations are also supported by the Access 2 system, but the calibration curve is calculated the same as for a quantitative assay.

• Qualitative assay calibrations establish a cutoff that the system uses to classify samples as reactive or non-reactive.

NOTE

Regardless of the type of calibration, the system reports the calibration with either a quantitative curve or a qualitative cutoff, according to the parameters defined in the assay protocol file (APF).

When you run calibration samples, the system evaluates the test results using acceptance criteria defined by the APF. The calibration either passes or fails.

The system also takes one of the following actions:

• If an assay calibration passes, the system establishes a new calibration curve or cutoff for processing samples.

• If an assay calibration fails, the system displays a failure code on the Calibration Data screen (see Table 6-10), displays a message in the Event Log, and flags test results (on the Test Results screen).

• If the first calibration for an assay fails, the system generates no test results for samples run.


Access 2 Operator’s Guide 6.1: Assay Calibrations

The system requires an active calibration for each requested test. If the calibration for the requested test has not been performed or is expired, the system prompts you to perform a calibration. If you process samples with an expired calibration, the system flags the test results. If a new calibration fails, the system calculates the test results using the previous active calibration.

For information about how to enter calibration test requests, see Chapter 3: Sample Management.

For information about reviewing test results and result flags, see Chapter 5: Test Results.

For help on how to interpret rejected calibrations, see Appendix A: Troubleshooting in the Reference Manual.

For information about calibration theory and qualitative or quantitative assays, see Chapter 3: Theory of Operation in the Reference Manual.

0521A.wmf

Figure 6-1 Calibration Flowchart

Set up calibratorsFor more detailed information abouthow to set up calibrators, see the Setting UpCalibrators procedure in this chapter.

Enter and run acalibration request

For more detailed information about how torequest a calibration test, see Chapter 3:Sample Management.

Review calibrationcutoffs and curves

For more detailed information about how toview calibration data, see the ViewingCalibration Data procedure in this chapter.



Calibration ScreenYou use the Calibration screen to:

• View the results of the active, previous active, or last run calibrations

• Print calibration reports

• View the calibration status of all calibrated assays

• Add, edit, and delete calibrators

To get to this screen from the Main Menu, select Calibration F5.

0766C.bmp

Figure 6-2 Calibration Screen

Filter (Field) Displays the applied filter and sort criteria.

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

Table 6-3 Calibration Screen Descriptions




Calibration Buttons (Buttons) Displays the assay calibrations that have run on the instrument you are using that meet the filter criteria. If there are more than 32 calibrations, use the scroll bar to view all of the calibrations.

You select a calibration button if you want to review or delete calibration data. Each button displays the following identifying information:

• Calibration name

The name of the assay that is calibrated.

• Reagent lot

The reagent lot number used for the assay calibration.

NOTES

• Calibration buttons only exist for calibrations that have run. If you want to review the calibrators that are configured for the workgroup, select Calibrator Setup F5.

• You can choose a button by touching it, selecting it with the mouse, or by using the [Tab] key.

Filter F1 (Button) Select to modify the applied filter or the sort order.

NOTE

If you are using the scroll bar on the Calibration screen, scroll to the top of the screen before applying a filter. If you do not scroll to the top, the results of the applied filter may not be displayed. You will then need to exit the screen, return to the screen, and apply the filter again.

Review Data F2 (Button) Select to display the Calibration Data screen for a selected calibration button. You can view the active curve or cutoff from this screen. If there is no active calibration (no calibration has passed), the system displays the last calibration that has been run.

Calibrator Setup F5 (Button) Select to go to the Calibration Setup screen. You can set up the calibrators, edit existing calibrators, or delete calibrators from this screen for all instruments in the workgroup.

Delete F6 (Button) Select to delete a selected calibration button. The calibration button is removed from the Calibration screen.

For information about deleting calibrations, see the Deleting Calibrations procedure in this section.

Print F7 (Button) Select to print the calibration report, which lists all the calibrations for the instrument.

For more information about how to print a report, see Section 6.3: Calibration Reports in this chapter.

Table 6-3 Calibration Screen Descriptions (continued)


Applying a Calibration Filter

Use this procedure to apply a filter to the calibration buttons on the Calibration screen. You can choose a filter and specify the direction of the sort order.

NOTE

If you are using the scroll bar on the Calibration screen, scroll to the top of the screen before applying a filter. If you do not scroll to the top, the results of the applied filter may not be displayed. You will then need to exit the screen, return to the screen, and apply the filter again.

Go to the Calibration screen. To get to this screen from the Main Menu, select Calibration F5.

Select Filter F1.


850C.bmp

Figure 6-4 Filter (Calibration) Window

Filter (Options) Select either the filter that displays all assay calibrations or the filter that displays only those assay calibrations with reagent on board the instrument.

Ascending (Box) Select to have the filter sort the calibrations in ascending, alphabetic order (A - Z). Leave the box clear to sort the calibrations in descending, alphabetic order (Z - A).

The calibrations are sorted by test name, then by reagent lot.

Table 6-5 Filter (Calibration) Window Descriptions

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Select one of the filter options.

Select the Ascending box if you want the system to display the calibrations in ascending, alphabetic order (A - Z). If you want to display the calibrations in descending, alphabetic order (Z - A), leave the box blank.

NOTE

The calibrations are sorted by test name, then by reagent lot.

Select OK F1.

The system applies the filter and displays the results on the Calibration screen.

Deleting Calibrations

Use this procedure to delete the stored data for an assay calibration and reagent lot. You would delete a calibration that is expired or one that you do not use anymore.

NOTE

You cannot delete the calibration data if the instrument is in the Running or Paused mode.


Select the button for the assay calibration and reagent lot you want to delete.

Select Delete F6.

The system displays a confirmation message.

Select OK F1.

The calibration and all of the stored data associated with the reagent lot listed on the button are deleted from the instrument.

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6.2: Reviewing Calibration Data Access 2 Operator’s Guide


6.2Reviewing Calibration Data

The system creates and stores calibration data for each calibration you run. Depending on the type of assay calibration, the system generates an associated calibration curve or cutoff. You can view this information and print it in a report format.

Calibrations using different reagent pack lots can be run for the same assay. When reviewing calibration data, be sure to select the calibration button and the reagent pack lot number of the calibration you want to view.

General calibration data includes:

• Selected assay and reagent pack lot number

• Calibrator lot number

• Calibration pass or fail status

• Date and time the calibration was run

• Expiration date and time for the calibration

• Test results

Result specific calibration data includes:

• Stated concentrations of analyte

• Actual measured response in RLUs and mean RLUs of the replicates

• The standard deviation (SD) of the RLUs and coefficient of variation (%CV)

• Calculated concentrations of analyte (or interpretations based on the generated cutoff)

• Flags

You can also view the associated calibration curve or cutoff. A calibration curve plots the measured RLUs of each replicate versus the concentration of analyte. Calibration cutoffs show the acceptance limits for individual replicates and for the mean of the replicates.

Access 2 Operator’s Guide 6.2: Reviewing Calibration Data

Stored Calibration Data

For calibrations with a cutoff, the system stores calibration data for the active and last run calibrations. For calibrations that produce a curve, the system stores calibration data for the active, previous active, and last run calibrations. You view stored data on the Calibration Data screen.

Active The most recent calibration that passed, unless you switch it with the previous active calibration.

Active calibrations are used to evaluate patient samples.

Previous Active

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

Last Run The results of the most recent calibration test request that either passed or failed.

If the last run calibration passes, it also becomes the active calibration.

Table 6-6 Stored Calibration Data



Calibration Data ScreensYou use the Calibration Data screen to:

• View active, previous active, or last run calibration data

• Record or view comments about a calibrator

• Print the Calibration Data Report for the displayed calibrator

• Switch to using the previous active calibration

To get to this screen from the Main Menu, select Calibration F5 to display the Calibration screen, then select the calibration button for the assay and reagent lot you want, then select Review Data F2.

NOTE

The format of the Calibration Data screen varies by whether the calibration results are expressed with a cutoff (qualitative) or with a curve (quantitative). Both formats and their screen descriptions are included below.

0768B.bmp

Figure 6-7 Calibration Data Screen (Cutoff)



0769C.bmp

Figure 6-8 Calibration Data Screen (Curve)

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

Reagent Lot (Field) Displays the assay reagent lot number used to generate the calibration data.

Established (Cutoff)orCalibrated (Curve)

(Field) Displays the date and time that the calibration was run.

Expiration (Field) Displays the date and time that the calibration expires.

Cutoff (Cutoff only) (Field) Displays the cutoff for the assay. The field is blank if no cutoff is defined for this assay.

Table 6-9 Calibration Data Screen (Cutoff and Curve) Descriptions



Curve (Field) Displays which of the stored calibrations are displayed.

• Cutoff values are Active or Last Run.

• Curve values are: Active, Previous Active, or Last Run.

You can change the stored calibration being reviewed by using Select Curve F1.

For more information about stored calibrations, see the Stored Calibration Data topic in this chapter.

Status (Field) Displays the status of the calibration: Passed or Failed. The status of a active or previous active calibration is always Passed. Only a last run calibration can have a Failed status.

Reason (Field) Displays the failure code for a failed calibration. The field is blank if the calibration passed.

For an explanation of failure codes, see the Calibration Failure Codes topic in this chapter.

Cal Lot (Field) Displays the calibrator lot number used to generate the calibration data.

Units (Field) For cutoffs, displays the units of measure for the assay, which are defined for the calibrator sample type in the APF.

(Field) For curves, displays the units of measure that are configured for the calibrator sample type. The calibrator sample type is defined in the APF and cannot be changed.

Data Table (Table) Displays a list of the calibration samples run and the results specific to each test replicate. The table also contains mean result information.

Data includes:

• Stated concentration:

- For curves, the concentration of analyte material in the calibrator level, as stated on the calibrator card.

- For cutoffs, the target concentration for the calibrator tested.

• RLU: The RLUs obtained for the calibration test or the calculated mean of the replicates.

NOTE

If a result does not meet the acceptance criteria, it is not included in the calculation of the mean.

• 1 SD: The standard deviation of the RLUs.

Table 6-9 Calibration Data Screen (Cutoff and Curve) Descriptions (continued)



Data Table(continued)

• %CV: The percent coefficient of variation for the calibrator replicates.

• Result (Cutoff only): The interpretation of the test as reactive or non-reactive, based on the generated cutoff.

NOTE

Confirmed or Not Confirmed is displayed for confirmatory assays (a numeric result is not applied).

• Calculated Conc. (Curve only): The actual concentration calculated for the calibrator tested and plotted on the curve. Values larger than ten digits are displayed in e-format.

• Flags: The system displays up to 2 result flags if the calibration results were flagged.

Acceptance Limits(RLUs) (Cutoff only)

(Table) Displays information about the upper and lower cutoff configured for this assay, including:

• Level: The calibrator level.

• Replicate Low: The lowest acceptable RLU for a replicate test.

• Replicate High: The highest acceptable RLU for a replicate test.

• Mean Low: The lowest acceptable RLU for the mean of the calibrator level replicates.

• Mean High: The highest acceptable RLU for the mean of the calibrator level replicates.

Curve (Log) or Curve (Linear) (Curve only)

(Chart) Displays the curve generated from the calculated RLU means for this calibration. You can use the left and right arrow keys (under the chart) to scroll and view all of the data points.

• Point cursor: A blue, vertical line that highlights the point you have selected.

• RLUs (y-axis): The y-axis displays the range of mean RLU readings for calibrator tested.

• Concentration (x-axis): The x-axis displays the range of calculated analyte concentration means for each calibrator tested. The x-axis may be plotted on a logarithmic (log) or linear scale.

• Points: The RLU and concentration means of each calibration test and its replicates are plotted as points, which make up the calibration curve.




Calibration Failure Codes

When a calibration fails, the system displays a failure code in the Status field on the Calibration Data screens. The failure codes below are for either cutoffs or curves.

Select Curve F1 (Button) Select to display a menu of these stored calibrations:

Active F1Displays the active calibration for the assay.

Previous Active F2 (Curve only)Displays the previous active calibration for the assay.

Last Run F3Displays the last run calibration.

For information about stored calibrations, see the Stored Calibration Data information in this chapter.

NOTE

Select Curve F1 is available only if other calibrations exist.

Switch Active Curve F2

(Button) Select to switch the active calibration for the assay with the previous active calibration. The previous active calibration becomes the active calibration and vice versa.

The system displays a confirmation message before the switch occurs.

Comment F3 (Button) Select to display the Calibration Comment window for the displayed calibration. You can enter, view, or edit a comment for the calibration. Comments print on the Calibration Data Report.

Print F7 (Button) Select to print the Calibration Data Report for the displayed calibration.


Failure Code Description

Bad Fit The curve does not meet the limits defined by the assay protocol file (APF). This may be caused by poor precision or a curve that was too flat or too steep.

CV Std 0 The %CV of the replicates for the S0 (zero) calibrator does not meet the limits defined by the APF.

Insuff Data The system did not have enough data to perform calibration calculations. This happens if two or more replicates are not calculated, due to a short sample or an instrument error.

Table 6-10 Calibration Failure Codes



Viewing Calibration Curves and Cutoffs

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


Select the button for the assay calibration and reagent lot you want to view.

Select Review Data F2.

The Calibration Data screen is displayed with the active calibration (curve or cutoff) for the assay you selected.

(Optional) To view the previous active calibration curve, select Select Curve F1, then Previous Active F2.

(Optional) To view the last run calibration curve or cutoff, select Select Curve F1, then Last Run F3.

For more information about active, previous active, and last run calibrations, see the Stored Calibration Data information in this chapter.

Limits The RLUs of either the individual replicates or the mean of the replicates were outside the ranges specified in the APF.

Max Iterate The system was unable to create a curve before performing the maximum number of calculation iterations. The system attempts to calculate the curve 100 times before generating this error.

No Fit The system was unable to fit a curve to the data points. Possible causes include math rule violations, such as division by zero or calculating the log of a negative.

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

Temp. Out The instrument case temperature changed more than 6°C while the system processed the test replicates.

Failure Code Description

Table 6-10 Calibration Failure Codes (continued)

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Switching the Active with the Previous Active Calibration

Use this procedure to switch the active calibration with the previous active calibration. This procedure is for quantitative assays only.

NOTES

• You cannot switch active and previous active calibrations while the system is in the Running or Paused mode.

• This procedure will not alter curve expiration dates or recalculate results for patient samples that have already been run.

• If there is no previous active calibration, the Switch Active Curve F2 button is unavailable.


Select the button for the assay calibration you want to switch.


The Calibration Data screen is displayed.

Select Switch Active Curve F2.

A confirmation message is displayed.

Select OK F1.

The active and previous active calibration curves are switched. The previous active calibration curve is displayed.

Adding a Calibration Comment

Use this procedure to enter, edit, or view a calibration comment.


Select a calibration button.


The Calibration Data screen is displayed.

Select Comment F3.

The Calibration Comment window is displayed.

Type a comment for the calibration.

Select OK F1.

The comment is applied to the calibration and is printed on the Calibration Data Report.

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Access 2 Operator’s Guide 6.3: Calibration Reports

6.3Calibration Reports

You can print calibration data in a report format. If a comment is entered for a calibration, the comment displays on the report. Printed calibration data reports include:

• Laboratory header information

• Date and time of printing

• Page number

• Line for the technologist signature

You can select the following report formats:

Calibration Report This report is printed from the Calibration screen. All of the calibrations, sorted by test name, then reagent lot are listed in this report.

Calibration Data Report(Cutoff)

This report is printed from the Calibration Data screen. The data and limits information for the displayed calibration are printed. The cutoff information is represented in a table format on the report.

Calibration Data Report(Curve)

This report is printed from the Calibration Data screen. The data and the graph are printed. The graph is an exact representation of the calibration curve for the displayed calibration.

Table 6-11 Calibration Report Formats


6.3: Calibration Reports Access 2 Operator’s Guide

Printing a Calibration Report

Use this procedure to print the Calibration Report or a Calibration Data Report.

Go to the Calibration Screen. To get to this screen from the Main Menu, select Calibration F5.

(Optional) To print a Calibration Data Report, go to the Calibration Data screen. To get to this screen from the Main Menu, select Calibration F5 to display the Calibration screen, then select a calibration button, then select Review Data F2.

Select Print F7.

A print message is displayed.

Select OK F1.

The system prints the report (see Figure 6-12, Figure 6-13, and Figure 6-14 for report examples).

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0790D.bmp

Figure 6-12 Calibration Report


123 Lake StreetCalibration Report Townsville, ST 33333Access 2 Immunoassay System 101-555-2323 ext. 109S/N 502338 Jane Smith

Filter: All Calibrations - Ascending Sorted by Test Name and Reagent Lot

Test Name Reagent LotAFP 029940aTnI 620004aTnI 620005CK-MB 093060CK-MB 113021EPO 094973FastTSH 117785FRT4 614500FRT4 614501IgG-Toxo 050088IgG-Toxo 080071MYO 053755Rub-IgG 060211Rub-IgG 120283TBhCG2 131654TSH 074523TSH 117785TotT3 002698

Page 1 of 1Technologist_________________________________________ Printed 04/04/07 12:43 PM


6.3: Calibration Reports Access 2 Operator’s Guide

0907C.bmp

Figure 6-13 Calibration Data Report (Cutoff)


123 Lake StreetCalibration Data Report Townsville, ST 33333Access 2 Immunoassay System 101-555-2323 ext. 109S/N 414141 Jane Smith

Test Name: IgM-Toxo Curve: Last Run: ActiveReagent Lot: 100112 Status: PassedEstablished 09/23/11 02:29 PM Reason: (if status is Failed, reason prints here) Expiration: 10/21/11 02:29 PM Cal Lot: 112001Cutoff: 360000 Units S/COComment:

Stated Conc. RLU 1 SD %CV Result FlagsC0 Non-Reactive 50000 Non-Reactive CalC0 Non-Reactive 50000 Non-Reactive Cal

Mean 50000.00 0.00 0.00C1 Reactive 900000 Reactive CalC1 Reactive 900000 Reactive Cal

Mean 900000.50 0.00 0.00

Page 1 of 1Technologist __________________________________________ Printed 09/23/11 03:19 PM

Acceptance Limits (RLUs)

Replicate Mean

Level Low High Low High

C0 10000 90000 10000 90000

C1 140000 1600000 140000 1600000




0791C.bmp

Figure 6-14 Calibration Data Report (Curve)


123 Lake StreetCalibration Data Report Townsville, ST 33333Access 2 Immunoassay System 101-555-2323 ext. 109S/N 500135 Jane Smith____________________________________________________________________________________________________Test Name: PSA-Hyb Curve: ActiveReagent Lot: 005711 Status: PassedCalibrated: 01/22/01 12:34 PM Reason: (if Status is Failed, reason prints here)Expiration: 02/19/01 12:34 PM Cal Lot: 006541Comment:

Stated Conc. ng/mL RLU 1SD % CV Calculated Conc. ng/mL FlagsS0 0.00 14804 No ValueS0 0.00 14927 0.00

Mean 14865.35 86.76 0.58 0.00S1 0.48 93587 0.48S1 0.48 94176 0.48

Mean 93881.30 416.06 0.44 0.48S2 2.04 349705 2.06S2 2.04 343755 2.02

Mean 346730.00 4207.29 1.21 2.04S3 10.10 1594880 10.03S3 10.10 1626570 10.24

Mean 1610725.00 22408.21 1.39 10.14S4 74.70 9777480 75.98S4 74.70 9492180 73.20

Mean 9634830.00 201737.56 2.09 74.59S5 145.00 15770900 145.85S5 145.00 15788900 146.10

Mean 15779900.00 12727.92 0.08 145.98

Page 1 of 1Technologist ______________________________________________ Printed 02-02-01 11:05 AM

P/N B14251D 9/14

6.4: Setting Up Calibrators Access 2 Operator’s Guide

6.4Setting Up Calibrators

You calibrate an assay on an instrument before you run tests for that assay on the instrument. However, before you calibrate, the solution used for calibrating the individual assay must be set up on the Access 2 system.

Most calibrators are multi-level. They contain more than one solution, with each solution containing a different level of analyte. When you add a multi-level calibrator to the system, you add all levels of the calibrator as one calibrator. When you select a multi-level calibrator to be used for a calibration, all levels of the calibrator are included in the selection.

When you set up a calibrator, you associate it with a calibrator lot. Calibrator lots that are set up on the system can be used to run calibrations on any instrument in your workgroup. In contrast, a calibration curve or cutoff is only valid on the instrument on which it was run.

For more information about running calibrations, see Chapter 3: Sample Management in this manual.


Access 2 Operator’s Guide 6.4: Setting Up Calibrators

Calibrator Setup ScreenYou use the Calibrator Setup screen to:

• View calibrator lot and expiration information for calibrators that are set up for all instruments in your system workgroup

• Add a calibrator

• Edit a calibrator

• Delete a calibrator

To get to this screen from the Main Menu, select Calibration F5 to display the Calibration screen, then select Calibrator Setup F5.

0771B.bmp

Figure 6-15 Calibrator Setup Screen



Calibrator List (Fields) Displays all of the calibrators set up for all instruments in your system workgroup. The following information about each calibrator is displayed:

• Test

Displays the test name.

• Calibrator Lot

Displays the calibrator lot number.

• Expiration

Displays the calibrator lot expiration date.

Add Calibrator F1 (Button) Select to setup a calibrator by entering information in the Add Calibrator window.

Edit Calibrator F2 (Button) Select to edit an existing calibrator by editing the information in the Edit Calibrator window.

Delete Calibrator F6 (Button) Select to delete a calibrator from all instruments in the workgroup.

Table 6-16 Calibrator Setup Screen Descriptions



0528A.wmf

Figure 6-17 Adding a Calibrator Flowchart

Calibration

Main Menu

CalibrationF5

Calibrator SetupF5

Calibrator Setup

Add CalibratorF1

Add Calibrator

Scan the calibratorbar code or type thecoded information

under the bar code

Calibratorinformation

correct?

Yes

No

OKF1



Adding a Calibrator

Use this procedure to add a calibrator to the system.

Go to the Calibrator Setup screen. To get to this screen from the Main Menu, select Calibration F5 to display the Calibration screen, then select Calibrator Setup F5.

Select Add Calibrator F1.

The Add Calibrator window is displayed.

0765B.bmp

Figure 6-18 Add Calibrator Window

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Bar Code (Field) Using the handheld bar code reader or keyboard, enter the bar code ID printed on the calibrator card for the calibrator to be added to the system.

Calibrator Name (Field) Displays the name of the calibrator.

Lot Number (Field) Displays the lot number for the calibrator.

Expiration Date (Field) Displays the expiration date of the calibrator.

Test (Column) Displays the test name of the calibrator.

Level (Column) Displays the level of the calibrator.

Table 6-19 Add Calibrator Window Descriptions



Use the handheld bar code reader to scan the bar code IDs listed on the calibrator card.

NOTES

• For some multi-level calibrators (usually quantitative assays), you must enter the bar code for each level in the Bar Code field. The system then displays the level information in the table.

• For other multi-level calibrators (usually qualitative assays), the system populates the calibrator levels, stated concentrations, and units automatically in the table.

• If you enter an expired calibrator, the system displays a warning message.

• If you cannot scan the bar code ID on the calibrator card, you can type the characters printed underneath the bar code in the Bar Code field.

Verify the information you entered is correct and select OK F1.

The system adds the calibrator to the system.

Editing a Calibrator

Use this procedure to edit the bar code ID of an existing calibrator.

Go to the Calibrator Setup screen. To get to this screen from the Main Menu, select Calibration F5 to display the Calibration screen, then select Calibrator Setup F5.

Select the calibrator to be edited.

Select Edit a Calibrator F2.

The Edit Calibrator window is displayed (identical to the Add Calibrator window).

Stated Concentration

(Column) Displays the stated concentration of each calibrator level.

NOTE

This column is only for quantitative assays.

Units (Column) Displays the units of measure for each calibrator level.

NOTE

This column is only for quantitative assays.

Table 6-19 Add Calibrator Window Descriptions (continued)

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Use the handheld bar code reader to enter the bar code ID.

NOTES

• If you cannot scan the bar code ID on the calibrator card, you can type the characters printed underneath the bar code in the Bar Code field.

• You cannot change the Calibrator Name, Lot Number, or Expiration Date.

• You cannot edit qualitative assays. The Bar Code field is unavailable for these assays.

Verify the information you entered is correct and select OK F1.

The system saves the calibrator information and updates the Calibrator Setup screen.

Deleting a Calibrator

Use this procedure to delete a calibrator from the system.

NOTES

• If any of the instruments in the workgroup are in the Running or Paused mode, the calibrator cannot be deleted.

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

Be sure the system is in the Ready or Not Ready mode, then go to the Calibrator Setup screen. To get to this screen from the Main Menu, select Calibration F5 to display the Calibration screen, then select Calibrator Setup F5.

Select a calibrator to delete from the system.

Select Delete Calibrator F6.

NOTES

• Deleting a calibrator will also delete all calibration curves associated with the calibrator lot.

• Within a workgroup, deleting a calibrator will delete it from all instruments in the workgroup.

The system displays a confirmation window.

Select Yes F1 to delete the calibrator from all instruments in the workgroup.

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Access 2 Operator’s Guide 7: Quality Controls

7Quality Controls

7.1 Quality Controls .............................................................................................7-3

Quality Control Screen......................................................................................7-5

Applying a QC Filter.........................................................................................7-7

Deleting QC Comparisons ................................................................................7-8

7.2 Reviewing Quality Control Charts and Data ............................................7-9

Westgard QC Rules...........................................................................................7-9

Levey-Jennings Charts .................................................................................... 7-10

QC Chart and Data Screen ..............................................................................7-11

Viewing Quality Control Charts and Data ...................................................... 7-15

Applying a QC Chart and Data Filter ............................................................. 7-15

Entering Quality Control Comments .............................................................. 7-17

Omitting a QC Data Point ...............................................................................7-17

Deleting a QC Point ........................................................................................ 7-18

Copying QC Data to Disk or USB Flash Drive .............................................. 7-19

Compare Charts Screen................................................................................... 7-21

Comparing QC Charts..................................................................................... 7-25

Saving QC Comparisons ................................................................................. 7-25

7.3 Quality Control Reports ..............................................................................7-26

Printing a QC Review Report ......................................................................... 7-26

Printing a QC Chart or Data Report................................................................ 7-28


7: Quality Controls Access 2 Operator’s Guide

7.4 Setting Up Quality Controls ........................................................................ 7-31

QC Setup Screen ............................................................................................. 7-33

Adding a Quality Control................................................................................ 7-34

Editing a Quality Control ................................................................................ 7-37

Deleting a Quality Control ..............................................................................7-37

7.5 Establishing QC Ranges ............................................................................. 7-39

Collecting Data to Establish QC Ranges ........................................................ 7-39

Assigning Temporary QC Ranges .................................................................. 7-41

7.6 Quality Control Worksheet......................................................................... 7-42

Quality Control Worksheet ............................................................................. 7-43


Access 2 Operator’s Guide 7.1: Quality Controls

7.1Quality Controls

Quality controls are samples of known reactivity. You can run quality control samples along with patient samples to monitor system performance.

The system performs quality control (QC) calculations by comparing the results to the acceptable range of expected values you entered during QC Setup. QC calculations include:

• The mean (average) test result value

• Standard deviation (SD) from the mean

• Percent coefficient of variation (%CV)

NOTE

These statistics are calculated on pooled data from all runs on a particular instrument of that QC level.

The system stores the QC data in the database. You can view, print, copy, or delete QC data. QC data can be viewed in a graphical format called a Levey-Jennings chart.

If the system is configured to apply Westgard rules to quality control test results, the system alerts you when a quality control test result violates an applied Westgard rule. When the system flags a result, the Quality Control status button turns red.

You can also enter comments for a specific patient result or quality control, and omit points from the calculations. For example, you may want to enter a comment for a known technical error. You may also want to enter a comment about why you are excluding the result. The system displays omitted results on the screen and in reports, but does not include them in calculations.

NOTE

Quality control samples should be run after any scheduled or unscheduled preventive maintenance or repair to verify calibration.


7.1: Quality Controls Access 2 Operator’s Guide

For information about how to enter quality control test requests, see Chapter 3: Sample Management.

For information about reviewing test results and result flags, see Chapter 5: Test Results.

For information about Westgard QC rules, see Section 7.2: Reviewing Quality Control Charts and Data.

For help on how to interpret failed quality controls, see Appendix A: Troubleshooting in the Reference Manual.

0750B-version1.1.wmf

Figure 7-1 Quality Controls Flowchart

Set up Quality Controls

Run QC tests

Review QC

For more detailed informationabout how to run QC tests, seeChapter 3 Sample Management inthe Operator's Guide

For more detailedinformation about how to

view QC charts and data,see the Viewing QC

Charts and Dataprocedure in this chapter

For more detailed informationabout how to set up qualitycontrols, see Setting up QualityControls in this chapter

Review QC chartsand data

Compare charts

For more detailedinformation about howto compare QC charts,see the ComparingQC Charts procedurein this chapter



Quality Control ScreenYou use the Quality Control screen to:

To get to this screen from the Main Menu, select Quality Control F4. Or, select the Quality Control button from any screen.

0713B.bmp

Figure 7-2 Quality Control Screen

• Review Levey-Jennings charts and data

• Compare Levey-Jennings charts of two or three quality controls

• Delete Levey-Jennings chart comparisons

• Set up quality controls

• Print reports

Quality Control Button

0581A.bmp

Filter (Field) Displays the current filter and sort criteria.

Entries (Field) Displays the number of quality control buttons that meet the filter criteria.

Table 7-3 Quality Control Screen Descriptions



QC Buttons (Buttons) Quality control and comparison buttons. If there are more than 28 buttons, use the vertical scroll bar to display additional buttons.

NOTE

The system only displays quality controls that have been set up and run on the instrument.

Each button contains the following information:

• Quality Control Button

QC name, lot number, test name, and instrument name.

• Comparison Button

Comparison label, saved comments, and instrument name.

Filter F1 (Button) Select to change the filter and sort order criteria. You can select a filter and the first and second sort order.

Available filters are:

• All controls

• All flagged controls

• Expired controls

• Non-expired controls

Review Chart and Data F2

(Button) Select to view the Levey-Jennings chart and QC point data for a specific quality control.

Compare Charts F3 (Button) Select to view the Levey-Jennings charts for two or three quality controls.

Delete Comparison F4

(Button) Select to delete one or more saved comparisons from the Quality Control screen.

QC Setup F5 (Button) Select to display the QC Setup screen and add, edit, or delete quality controls across all instruments in the workgroup.

Print F7 (Button) Select to print a report of the quality controls that are currently set up for the workgroup.

Table 7-3 Quality Control Screen Descriptions (continued)



Applying a QC Filter

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

The screen is always filtered. The default filter is All Controls - sorted by Test Name, then by Control Name.

NOTE

If you change the system ID for an instrument in your workgroup, the instruments selected in the applied filter may also change. Test and update the filter to make sure it operates as expected.

Use this procedure to select a filter for the quality control data.

Go to the Quality Control screen. To get to this screen from the Main Menu, select Quality Control F4.

Select Filter F1.


0758A.bmp

Figure 7-4 Filter (Quality Controls) Window

Filter (List) Select a filter.

Instrument (List) Select from each instrument in the workgroup.

Table 7-5 Filter (Quality Controls) Window Descriptions

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Select a filter from the list. The default sort orders for all filters are:

• 1st sort order: Test Name

• 2nd sort order: Control Name

(Optional) To use a different sort order, select the sort order you want to apply.

(Optional) To sort the quality controls in descending order by quality control name, clear the Ascending box.

Select OK F1.

The system displays all quality controls that meet the selected parameters on the Quality Control screen.

Deleting QC Comparisons

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


Select Delete Comparison F4.

The Delete Comparison window is displayed.

Select one or more comparisons to delete from the list.


Select OK F1.

Sort Order (Option) Select to define the primary and secondary sort order.

Ascending (Box) Select to sort data in ascending order. You can clear the box to sort the data in descending order.

Description (Field) Displays a description of the selected filter.

Table 7-5 Filter (Quality Controls) Window Descriptions (continued)

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Access 2 Operator’s Guide 7.2: Reviewing Quality Control Charts and Data

7.2Reviewing Quality Control Charts and Data

The system stores all quality control test results and QC calculations for each quality control. You can review QC data, apply a filter to the quality controls displayed, and compare Levey-Jennings charts for two or more quality controls.

QC data includes:

• Quality control name and lot number

• Date range (for all results)

• Number of results used in QC calculations (excluding omitted results)

• All test results (including all reagent pack lots used)

• Information set up in the system for the quality control

Each test result includes the measured response in RLUs, standard deviation intervals (SDI), date and time of completion, applied QC rules, flags, and comments. Setup information includes the quality control expiration date, expected mean, and expected SD from the mean.

Westgard QC Rules

Westgard QC rules are interpretive rules developed to avoid excessive false rejection rates, to improve quality monitoring, and to decrease subjectivity of data analysis.

Each laboratory determines the QC rules to apply and the course of action to take when a result violates a rule. Understand how your laboratory uses QC rules before you set up controls.

Application of a QC rule consists of screening quality control test results for the number of standard deviations (SD) above or below the mean, and for the number of consecutive occurrences. Data points are colored red to mark violations of rules. For


7.2: Reviewing Quality Control Charts and Data Access 2 Operator’s Guide

each combination of control lot and reagent, you can apply one or more of these QC rules:

• 12s (1-2s) - The system marks a data point if it is more than 2 SD from the mean.

• 22s (2-2s) - The system marks a data point if two consecutive points of a given quality control are more than 2 SD from the mean in the same direction. The system only marks the second point.

• 13s (1-3s) - The system marks a data point if it is more than 3 SD from the mean.

• 41s (4-1s) - The system marks a data point if four consecutive points of a given quality control are more than 1 SD from the mean in the same direction. The system only marks the fourth point.

• 10x (10x) - The system marks a data point if ten consecutive points of a given quality control are on the same side of the mean (for example, ten points are above the mean). The system only marks the tenth point.

Levey-Jennings Charts

A Levey-Jennings chart is a graphical representation of quality control test results. A point represents a result and the distance on, above, or below the expected mean result (measured in units of standard deviation between -3SD and +3SD).

You can view a Levey-Jennings chart to determine if quality control test results, over a period of time, are within range or out of range. QC results that are within an acceptable range form a normal distribution pattern with equal numbers of points above and below the mean. A normal distribution has approximately:

• 70% of the points between +1 SD and -1 SD

• 25% between +1 SD and +2 SD or between -1 SD and -2 SD

• 5% between +2 SD and +3 SD or between -2 SD and -3 SD

You can detect out of range QC data by looking for the flagged result. The Access 2 instrument flags results that are out of range, based on the values you input during the quality controls setup.



QC Chart and Data ScreenYou use this screen to:

• View QC data and Levey-Jennings charts

• Edit the date range of the quality control

• Copy QC data to a disk or USB flash drive

• Print reports

To get to this screen from the Main Menu, select Quality Control F4 to display the Quality Control screen, select the quality control you want to view, then select Review Chart and Data F2.

0751C.bmp

Figure 7-6 QC Chart and Data Screen

Test (Field) Displays the test name.

Control (Field) Displays the quality control name.

Table 7-7 QC Chart and Data Screen Descriptions



Control Lot (Field) Displays the quality control lot number.

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

Instrument (Field) Displays the number of the instrument the test was run on.

Pipettor (Field) Displays the value N/A. This field is reserved for future use.

Reagent Lot (Field) Displays the test reagent pack lot number used for the QC run. The default value is All.

Start (Field) Displays the beginning date of the QC results in the chart. Unless you edit the date range, the beginning date is the first day QC test results were obtained.

End (Field) Displays the ending date of the QC results in the chart. Unless you edit the date range, the ending date is the day the most recent QC results were obtained.

Mean (Field) Displays the calculated mean of the points within the date range. The value displays with the number of decimal places defined for the assay, plus one additional decimal place, up to a maximum of four decimal places. Omitted points are not included in the calculations.

For information about defining the decimal places for an assay, see Section 4.4: Test Setup in the Reference Manual.

SD (Field) Displays the calculated standard deviation (SD) for the points within the date range. The value displays with the number of decimal places defined for the assay, plus one additional decimal place, up to a maximum of four decimal places. Omitted points are not included in the calculations.


%CV (Field) Displays the calculated coefficient of variation (%CV) of the points within the date range. The value displays with two decimal places. Omitted points are not included in the calculations.

Points (Field) Displays the number of points within the date range used to calculate the mean, SD, and %CV. Omitted points are displayed on the chart with a diagonal line through them, but are not included in the calculations.

Table 7-7 QC Chart and Data Screen Descriptions (continued)



Levey-Jennings Chart (Chart) Displays a graph of the plotted points from each control. Points for up to 31 days can be viewed at once. You can scroll left to right and back, to view all of the data points, using the arrow buttons beneath the chart. Also see the Levey-Jennings Charts topic in this section.

• Point cursor

The blue vertical line on the graph. You can move the line by using the left and right arrow keys (found by each corner of the chart). This line marks the point you have selected.

• Calibration Line

The dotted vertical line on the graph. This line marks a changed calibration curve between the point the line runs through and the previous point.

• Y-axis Left Scale

Displays the 7 y-axis coordinates. These are the stated values for the mean and 1, 2, and 3 SDs above and below the mean.

• Y-axis Right Scale

Displays the 7 y-axis coordinates. These mark the mean and 1, 2, and 3 SDs above and below the mean.

• X-axis

Displays the dates for the chart.

• Points

Represent the numerical value of the result. A diagonal line through the point indicates an omitted point. Points greater than 3 SD above the mean are indicated as solid triangles on the +3 SD line, and points greater than 3 SD below the mean are indicated as solid triangles on the -3 SD line. Points that violate QC rules are colored red.




Data Grid (Table) Displays a list of QC results and information specific to each data point within the current date range, and contains the following columns:

• Value

Displays the result and the unit of measure.

• SDI

Displays the number of SD intervals the result is above or below the expected mean.

• Completion

Displays the date and time of the completed result.

• QC Rules

Displays the QC rules applied to the test in bold black type and displays the violated rules in red type with an asterisk on both sides.

• Comment

Select to read or enter a comment for a quality control sample. The default value is no comment (pen). After you enter a comment and select OK, the pen symbol turns into a notepad.

• Omit

Select to omit the result from QC calculations (point remains on chart).

• Pipettor

Displays the value N/A. This field is reserved for future use.

When you select a row in the data grid, the corresponding point is displayed on the Levey-Jennings chart.

Filter F1 (Button) Select to limit displayed data to certain reagent lots and date ranges. For more information, see the Applying a QC Chart and Data Filter topic.

Delete Point F5 (Button) Select to delete the currently selected point and all of that point data from the system. You must have a password to use this feature. For more information regarding passwords, see Chapter 4: System Configuration in the Reference Manual.

Copy to Disk F6 (Button) Select to copy QC data to a disk or USB flash drive. For more information, see the Copying QC Data to Disk or USB Flash Drive procedure in this section.

Print F7 (Button) Select to print the QC chart and data for the currently selected quality control.




Viewing Quality Control Charts and Data

Use this procedure to view the quality control data for a selected test. If you want to view or compare more than one test, see the Comparing QC Charts procedure in this section.


Select the quality control you want to view.

Select Review Chart and Data F2.

The QC data for the past 31 days is displayed on the QC Chart and Data screen.

NOTE

Quality control tests may be completed while you are reviewing this screen. To refresh the information displayed, exit the screen and redisplay it.

(Optional) To display data for a certain date range, or for a certain reagent pack lot number, apply a filter. For more information, see the Applying a QC Chart and Data Filter procedure in this section.

(Optional) To add, edit, or view a comment for a selected result, select the Comment button (pen or notepad) next to the appropriate result.

(Optional) To omit data from the QC calculations, select the Omit box next to the appropriate result.

Applying a QC Chart and Data Filter

A QC chart and data filter controls the amount of data displayed on the QC Chart and Data screen and printed in reports. The filter limits data according to the following parameters:

• By date range - You can display data for the last week, the last month, or you can specify a starting and ending date.

• By reagent lot - You can display data from a single reagent lot or all reagent lots.

Use the following procedure to apply a filter to the QC Chart and Data screen.

Go to the QC Chart and Data screen. To get to this screen from the Main Menu, select Quality Control F4, select the quality control for which you intend to view data, then select Review Chart and Data F2.

Select Filter F1.


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1026A.bmp

Figure 7-8 Filter (QC Chart and Data) Window

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

• Last Week - Display data from the last 7 days

• Last Month - Display data from the last 31 days

• Specify - Enter a starting and ending date

NOTE

When viewing charts for date ranges greater than 31 days, the last date displayed on the chart will be the date of the most recent point in the date range.

Date Range (Options) Select a date range. Options are:

• Last Week - Display data from the last 7 days

• Last Month - Display data from the last 31 days

• Specify - Enter a starting and ending date

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

View Specific Pipettor

(Boxes) These boxes are reserved for future use.

Table 7-9 Filter (QC Chart and Data) Window Descriptions

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Select a single reagent lot to view, or select All to view data for all lots of the reagent for the selected test.

Select OK F1.

The system applies the filter and displays the results on the QC Chart and Data screen.

Entering Quality Control Comments

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


Select a quality control for comment.


The QC Chart and Data screen is displayed.

Select the Pen or Notepad button next to the appropriate result to display the QC Comment window.

In the Comment field, enter or edit comments. Or, to delete an existing comment, select it and press [Backspace].

To save comments, select OK F1.

Omitting a QC Data Point

Use this procedure to omit a point from the mean, SD, and %CV calculations (QC calculations). The point remains on the chart, marked as omitted by a diagonal line through it.


Select the quality control that contains the point you want to omit.

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The pen indicates no comments are associated with the sample.

The notepad indicates comments are associated with the sample. These comments were entered in the QC Comment window.

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Select a data point to be omitted from the data table.

Select the Omit box.

The system removes the data point from the QC calculations.

(Optional) To restore an omitted data point to the QC calculations, clear the Omit box.

NOTE

If a data point is omitted by the system due to a fatal flag or other error condition, the omission is permanent and the Omit box cannot be cleared.

Deleting a QC Point

Use this procedure to delete a selected point from the screen, reports, and statistical calculations. You must have the correct system password to use this option. An information event is created in the Event Log.


Select the quality control that contains the point you want to delete.



Select the point to delete. Touch the point or use the arrow keys in the bottom corner of the chart to select the point.

Select Delete Point F5.

You must enter the correct password. A warning message is displayed.

Select OK F1 to delete the point from the system.

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Copying QC Data to Disk or USB Flash Drive

Use this procedure to copy QC data to a 3.5-inch high density, DOS-formatted disk or USB flash drive.

NOTE


The Access 2 system copies the QC data into a comma-separated field format that you can import to a PC-based spreadsheet program. The QC data fields are:

• Control lot headers

• Control lot data

• Data point headers

• Rows of data point values

NOTE

Copying QC data does not remove it from the database.

Be sure the system is in the Ready or Not Ready mode, then go to the Quality Control screen. To get to this screen from the Main Menu, select Quality Control F4.

Select a quality control to copy.

To reduce or expand the number of quality controls displayed on the Quality Control screen in order to locate the quality control, select Filter F1 and apply a filter. For more information about how to use a filter, see the Applying a QC Filter procedure in this chapter.

Insert the disk or flash drive into the PC.

• To copy data to a 3.5-inch disk, insert a disk into the 3.5-inch disk drive of the PC.

NOTE

Be sure you insert the disk into the 3.5-inch disk drive of the PC, not the Access 2 instrument.

• To copy data to a USB flash drive, insert a flash drive into a port on the front of the PC. If the front of the PC does not contain a USB port, use a port on the back of the PC.

NOTE

For instruments set up to perform system backups using a USB flash drive, the backup drive might already be in one of the USB ports on the back of the PC.

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Use a different flash drive to copy data. Do not disturb the flash drive used for backups when inserting and removing the flash drive for copying data.

Select Review Chart and Data F2 to display the QC Chart and Data screen, then select Copy to Disk F6.

The Copy to Disk window is displayed.

Enter a name and file extension for the data file in the File Name field.

NOTES

• If you do not enter a file name or extension, the system supplies a default file name based on the date and time and a .csv (comma delimited) extension.

• If the file name already exists, the system displays a message. To overwrite the existing file, select Yes F1. To rename the new file, select Cancel F8.

(Optional) If your instrument has USB flash drive technology, confirm that the correct drive is selected from the Drive list, or select a different drive.

NOTE

Unless directed by Technical Support, do not copy data to the C: Console PC

drive or any drive labeled BACKUPDRIVE.

(Optional) If the 3.5-inch disk is not formatted, select the Format Disk option.

Select OK F1.

A progress window is displayed.

• To stop the copy process at any time, select Cancel F8.

When the copy process is complete, the system displays a message. Remove the disk or flash drive from the PC and label it.

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Compare Charts ScreenYou use this screen to:

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

• Save a comparison of the charts

To get to this screen from the Main Menu, select Quality Control F4 to display the Quality Control screen, select the quality controls you want to compare, then select Compare Charts F3.

0752C.bmp

Figure 7-10 Compare Charts Screen

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

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

Table 7-11 Compare Charts Screen Descriptions



Mean (Field) Displays the calculated mean of the points within the date range. The value displays with the number of decimal places defined for the assay, plus one additional decimal place, up to a maximum of four decimal places. Omitted points are not included in the calculations.


SD (Field) Displays the calculated standard deviation of the points within the date range. The value displays with the number of decimal places defined for the assay, plus one additional decimal place, up to a maximum of four decimal places. Omitted points are not included in the calculations.


%CV (Field) Displays the calculated coefficient of variation of the points within the date range. The value displays with two decimal places. Omitted points are not included in the calculations.

Points (Field) Displays the number of points within the date range used to calculate the mean, SD, and %CV. Omitted points are displayed on the chart with a diagonal line through them, but are not included in the calculations.


(Chart) Displays two or three graphs of the plotted points from each quality control. You can scroll left to right and back, to view all of the data points, using the horizontal scroll bar.

• Point cursor

The blue vertical line on the graph. You can move the line by using the left and right arrow keys (found by each corner of the chart). This line marks the point you have selected.

• Y-axis Left Scale

Displays the 7 y-axis coordinates. These are the stated values for the mean and the 1st, 2nd, and 3rd SDs above and below the mean.

• Y-axis Right Scale

Displays the 7 y-axis coordinates. These mark the mean and the 1st, 2nd, and 3rd SDs above and below the mean.

• X-axis

Displays the dates for the chart.

• Points

Represent the numerical value of the result. A diagonal line through the point indicates an omitted point. Points greater than 3 SD above the mean are indicated as solid triangles on the +3 SD line, and points greater than 3 SD below the mean are indicated as solid triangles on the -3 SD line. Points that violate QC rules are colored red.

Table 7-11 Compare Charts Screen Descriptions (continued)



Arrow Buttons Select to move the point cursor on the chart left or right to the next data point, and to select the corresponding row of the data table. The chart and table scroll as necessary to display the new selection.

Save Comparison F1

(Button) Select to save the comparison. If you save the comparison, the system creates a comparison button. You can then select the comparison button from the Quality Control screen to view it.

Review Chart and Data F2

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

Edit Date Range F4 (Button) Select to change a date range of QC points to view.

Table 7-11 Compare Charts Screen Descriptions (continued)



0779C.wmf

Figure 7-12 Comparing QC Charts Flowchart

Is correct daterange displayed?

Save thecomparison?

Continue reviewing or processing data

Quality Control

Select two or three qualitycontrols to compare

Compare ChartsF3

Compare Charts

Charts with points for thepast 31 days are displayed

Save ComparisonF1

Save Comparison

Enter text to name thecomparison

Edit Date RangeF4

Edit Date Range

Change the date range

No

Yes

No

Yes

Main Menu

Quality ControlF4



Comparing QC Charts

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


Select a minimum of two and a maximum of three quality controls for comparison.

To remove a quality control from your selection, select the quality control button again.

Select Compare Charts F3.

The QC data for the past 31 days is displayed on the Compare Charts screen.

(Optional) To change the date range of the displayed data, select Edit Date Range F4 and then enter the date range you want to view.

(Optional) To save the comparison for viewing again, select Save Comparison F1. For more information about how to save comparisons, see the Saving QC Comparisons procedure in this section.

(Optional) To view one of the charts in more detail, select Review Chart and Data F2, then select the button corresponding to that chart.

Saving QC Comparisons

Use this procedure to save the comparison from the Compare Charts screen.

Select Save Comparison F1 to save the selected quality controls as a comparison button on the Quality Control screen.

The Save Comparison window is displayed.

Enter text for the comparison button (notes or information about the comparison) in the Line 1 and Line 2 fields.

Select OK F1 to save the comparison and create a button on the Quality Control screen.

NOTE

You can delete a saved comparison from the Quality Control screen using Delete Comparison F4.

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7.3: Quality Control Reports Access 2 Operator’s Guide

7.3Quality Control Reports

You can print QC data and charts or a list of quality controls in a report format. For QC data and charts, the system prints the displayed data. To print what is not displayed, use the date range option.

The report formats you can select from are:

Printing a QC Review Report

Use this procedure to print a QC Review Report (see Figure 7-13).


Select Print F7.

The system sends the report to the printer.

QC Review Report This report contains all of the quality controls in the current filter and includes the quality control lot, test name, reagent lot, expiration, and instrument. The report is available only from the Quality Control screen.

QC Data Report This report contains the data for a specific quality control and date range. The report is available only from the QC Chart and Data screen.

QC Chart Report This report contains a Levey-Jennings chart for a specific quality control and date range. If the applied filter exceeds 31 days, the data continues on additional pages. The report is available only from the QC Chart and Data screen.

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Access 2 Operator’s Guide 7.3: Quality Control Reports

0772C.bmp

Figure 7-13 QC Review Report


123 Lake Street Townsville, ST 33333

QC Review Report 101-555-2323 ext. 109Access 2 Immunoassay System Jane Smith

Filter: All Controls - Sorted by Test Name and Control NameControl Name Control Lot Test Name Expiration Instrument PipettorLowPos 012461 Chl-Ag 01/01/03 500135 N/ACardiac A 1234567A CK-MB 11/11/02 501240 N/ACardiac B 1234567B CK-MB 11/11/02 501240 N/ACardiac C 1234567C CK-MB 11/11/02 501240 N/ACardiac A 1234567A cTnI 11/11/02 500135 N/ACardiac A 1234567A cTnI 11/11/02 501240 N/ACardiac B 1234567B cTnI 11/11/02 500135 N/ACardiac B 1234567B cTnI 11/11/02 501240 N/ACardiac C 1234567C cTnI 11/11/02 500135 N/ACardiac C 1234567C cTnI 11/11/02 501240 N/ACardiac A 1234567A Dig 11/11/02 501240 N/ACardiac B 1234567B Dig 11/11/02 501240 N/ACardiac C 1234567C Dig 11/11/02 501240 N/AHigh Control 98765C freePSA 03/03/03 500135 N/ALow Control 98765A freePSA 03/03/03 500135 N/ACardiac A 1234567A MYO 11/11/02 501240 N/ACardiac B 1234567B MYO 11/11/02 501240 N/ACardiac C 1234567C MYO 11/11/02 501240 N/AHigh Control 98765C PSA-Hyb 03/03/03 500135 N/ALow Control 98765A PSA-Hyb 03/03/03 500135 N/A

Page 1 of 1Technologist ____________________________________________ Printed 10/10/02 02:43 PM



Printing a QC Chart or Data Report

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

Go to the QC Chart and Data screen. To get to this screen from the Main Menu, select Quality Control F4, select the quality control you want to print, then select Review Chart and Data F2.

Select Print F7.

The Print window is displayed.

0759A.bmp

Figure 7-14 Print (QC Chart and Data) Window

Select the QC report you want to print.

(Optional) To print a wider range of data than you can view on the screen for a QC Data or QC Chart report, select Print Entire Date Range.

Report Type (Boxes) Select either chart, data table, or both to print. For an example of each report format, see Figure 7-16 and see Figure 7-17.

Print Entire Date Range

(Box) Select to print the entire date range selected in the QC Chart and Data screen. If the date range is more than 31 days, charts continue on additional pages.

Clear to print only the data on the screen. Chart reports are limited to 31 days, and data reports print only four lines.

Table 7-15 Print (QC Chart and Data) Window Descriptions

1

2

3


Access 2 Operator’s Guide 7.3: Quality Control Reports

Select OK F1.

The system sends the report to the printer.

0773E.bmp

Figure 7-16 QC Data Report

4


123 Lake StreetQC Data Report Townsville, ST 33333Access 2 Immunoassay System 101 - 555 - 2323 ext. 109S/N 501240 Jane Smith

Test: TropI Start Date: 10/01/11Control: CardiacB End Date: 10/07/11Control Lot: 1234567B Points: 7Expiration: 11/11/11 Mean: 0.3054Stated Mean: 0.3000 SD: 0.0370Stated SD: 0.1000 %CV: 12.12Des. Pipettor: N/A Units: ng/mL

Value SDI Completion QC Rules Comment Omit Reagent PipettorLot

0.303 ng/mL 0.026 10/01/11 08:39 PM 130161 N/A0.299 ng/mL -0.015 10/02/11 08:35 PM 130161 N/A10.418 ng/mL 101.180 10/03/11 08:25 PM *1**3* Contaminated X 130161 N/A

sample- retestwith new sample

0.294 ng/mL -0.062 10/03/11 09:10 PM 130161 N/A0.247 ng/mL -0.526 10/04/11 08:37 PM 130161 N/A0.292 ng/mL 0.076 10/05/11 08:52 PM 130161 N/A0.361 ng/mL 0.610 10/06/11 03:12 PM 144219 N/A0.588 ng/mL 2.882 10/07/11 04:18 PM *1* Sample left in X 144219 N/A

instrument toolong- retest

0.342 ng/mL 0.420 10/07/11 04:56 PM 144219 N/A

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

Page 1 of 1Technologist _____________________________________________ Printed 10/10/11 05:32 PM



0774E.bmp.

Figure 7-17 QC Chart Report

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Access 2 Operator’s Guide 7.4: Setting Up Quality Controls

7.4Setting Up Quality Controls

You can set up quality controls to make them available to run on your Access 2 system and to define quality control (QC) rules the system checks test results against. A quality control lot can be configured for up to 50 assays. You must set up each new lot of a quality control before you can select it during test request entry. You must complete the following fields:

• Control

• Lot number

• Expiration date

• Sample type

• Test name

• Mean

• SD

• Units

• Westgard QC rules

You must establish the acceptable range of expected values (mean and standard deviation) for quality controls specific to your Access 2 instrument. For each new lot, use the manufacturer’s suggested ranges from the reagent instructions for use as a guideline for the expected mean and standard deviation (SD), until you have processed enough quality control samples to determine a mean and SD specific to the instrument you use.

For more information on QC rules, see the Westgard QC Rules topic in Section 7.2: Reviewing Quality Control Charts and Data.


7.4: Setting Up Quality Controls Access 2 Operator’s Guide

0780A.wmf

Figure 7-18 Setting Up Quality Controls Flowchart

Main Menu

Quality ControlF4

Quality Control

QC SetupF5

QC Setup

Add ControlF1

OKF1

Done

Add Control

Enter quality controland set up QC rules

All controlparametersentered?

Yes

No



QC Setup ScreenYou use this screen to:

• View all of the quality controls for all of the instruments in the workgroup

• Add a quality control to be used on any instrument in the workgroup

• Edit an existing quality control

• Delete a quality control

To get to this screen from the Main Menu, select Quality Control F4 to display the Quality Control screen, then select QC Setup F5.

0753C.bmp

Figure 7-19 QC Setup Screen



Adding a Quality Control

Use this procedure to define a new quality control and enter the tests, means, SDs, and QC rules for that quality control.

Go to the QC Setup screen. To get to this screen from the Main Menu, select Quality Control F4 to display the Quality Control screen, then select QC Setup F5.

Select Add Control F1.

The Add Control window is displayed.

QC Setup List (List) Displays information for all quality controls defined in the workgroup.

The four columns of information are:

• Control

Displays the name of the quality control.

• Control lot

Displays the number of the quality control lot.

• Expiration

Displays the quality control lot expiration date.

• Sample

Displays the sample type.

Add Control F1 (Button) Select to add a quality control to the QC Setup list and enter the tests, means, SDs, units, and QC rules to define it.

Edit Control F2 (Button) Select to edit an existing quality control.

Delete Control F6 (Button) Select to permanently remove a quality control from the system.

Table 7-20 QC Setup Screen Descriptions

1

2



0762C.bmp

Figure 7-21 Add Control Window

Control (Field) Enter a unique name for the new quality control.

Lot Number (Field) Enter a unique lot number for the new quality control.

Expiration (Field) Enter the expiration date for the new quality control lot number.

Sample Type (List) Select a sample type from the list.

Test Name (List) Select a test name from the list of tests enabled on any instrument in the workgroup.

Mean (Field) Enter the expected mean for the test.

SD (Field) Enter the expected SD for the test.

Units (Field) Displays the test units.

Westgard QC Rules (Boxes) Select the rules to apply for the new control.

Your laboratory determines the Westgard QC rules to apply and the course of action you need to take when a result violates a rule. Understand how your laboratory uses QC rules before you add controls. For more information, see the Westgard QC Rules topic in Section 7.2: Reviewing Quality Control Charts and Data.

Designated Pipettors

(Column) Displays the value N/A. This column is reserved for future use.

Table 7-22 Add Control Window Descriptions



Enter the quality control information and select the appropriate options to define the new quality control.

NOTES

• Some multi-level quality controls have the same lot number for each level. You can add the level (such as 1, 2, or 3) to the lot number to make it unique.

• The expiration date format follows the format you set up on the System Setup screen. The system displays a message if the incorrect format is used. For more information about setting the date format, see Chapter 4: System Configuration in the Reference Manual.

• For a qualitative test, the standard deviation must be greater than 1. If you enter an expected SD that is less than 1, the QC chart may not display the data correctly.

(Optional) To delete the information in a row and start over with a blank row, select Clear Row F3.

Select OK F1.

The system saves the new quality control and adds it to the QC Setup list.

NOTE

A warning message is displayed if you have missing or incomplete information.

(Optional) To delete the new quality control without saving it, select Cancel F8 and return to the QC Setup screen.

Record the quality control information on the QC worksheet (see Figure 7-23). Do this for any quality control you set up.

Clear Row F3 (Button) Select to clear the information from a selected row.

Designate Pipettor F4

(Button) This button is reserved for future use.

Table 7-22 Add Control Window Descriptions (continued)

3

4

5



Editing a Quality Control

Use this procedure to edit an existing quality control.

Go to the QC Setup screen. To get to this screen from the Main Menu, select Quality Control F4 to display the Quality Control screen, then select QC Setup F5.

Select a quality control to edit.

Select Edit Control F2.

The Edit Control window is displayed. This window is similar to the Add Control window.

To edit the expected mean for a quality control test, enter the new value in the Mean field.

To edit the expected standard deviation for a quality control test, enter the new value in the SD field.

To change the selected QC rules, select or clear the Westgard QC Rules boxes. For more information, see the Westgard QC Rules topic in Section 7.2: Reviewing Quality Control Charts and Data.

Select OK F1.

The system saves the quality control and updates the QC Setup screen.

NOTE

A warning message is displayed if you have missing or incomplete information.

Deleting a Quality Control

Use this procedure to delete a quality control.

NOTE

If any of the instruments in your workgroup are in the Running or Paused mode, the quality control cannot be deleted.

Be sure the system is in the Ready or Not Ready mode, then go to the QC Setup screen. To get to this screen from the Main Menu, select Quality Control F4 to display the Quality Control screen, then select QC Setup F5.

Select the quality control you want to delete from the QC Setup list.

Select Delete Control F6.

A password window is displayed.

1

2

3

4

5

6

7

1

2

3



Enter the correct password.


Select OK F1.

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

4

5


Access 2 Operator’s Guide 7.5: Establishing QC Ranges

7.5Establishing QC Ranges

This section provides a recommendation to establish quality control ranges for the Access 2 Immunoassay System. This is only a recommendation and is not intended to replace your existing laboratory procedure(s). Use this procedure, along with your standard laboratory practices and manufacturer’s recommendations, for your quality controls.

You can use the Quality Control worksheet (see Figure 7-23) to record the quality controls you set up and all of the data associated with them.

NOTES

• Use fresh quality control materials for best results.

• Do not re-use quality controls by pooling into sample cups or storage containers.

• For more information about requesting QC tests, see Section 3.4: Quality Control Test Requests in this manual.

Collecting Data to Establish QC Ranges

Use this procedure, along with your standard laboratory procedure, to establish quality control ranges.

Required Materials

• Access 2 system assay calibrators (2 lots, if available)

• Access 2 system reagent packs (2 lots, if available)

• Tri-level quality controls (prepare the quality controls according to the manufacturer’s instructions)


7.5: Establishing QC Ranges Access 2 Operator’s Guide

Steps

Run 1 or 2 replicates of each quality control one time each day. Vary the sequence in which the quality control samples are processed.

Record the values, using the following guidelines:

• If 1 replicate is run, record only 1 value per quality control level.

• If 2 replicates are run, record both individual values.

• Do not exceed 2 recorded values per day.

Obtain a minimum of 15 values per quality control level on at least 3 different calibration curves (45 values minimum). Use a combination of fresh and stored calibrations.

Calculate the mean, %CV, 1SD, 2SD, and 3SD values, and the 3SD range for each quality control level/analyte combination.

Perform outlier evaluation:

• Remove any values outside of the 3SD range (outliers), then recalculate the mean, %CV, 1SD, 2SD, and 3SD values. Continue to step 6.

• If no outliers are detected, use the data calculated in step 4 and continue with step 7.

Perform a second outlier evaluation. Remove any values outside of the 3SD range, then recalculate the mean, %CV, 1SD, 2SD, and 3SD values.

Calculate the acceptable 1SD, 2SD, and 3SD quality control ranges.

NOTE

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.

Periodically recalculate the values and ranges during the life of the control lot.

1

2

3

4

5

6

7

8


Access 2 Operator’s Guide 7.5: Establishing QC Ranges

Assigning Temporary QC Ranges

Use this procedure to assign temporary or provisional quality control ranges.

Run 1 or 2 replicates of each quality control daily.

Record the values, using the following guidelines:

• If 1 replicate is run, record only 1 value per quality control level.

• If 2 replicates are run, record both individual values.

• Do not exceed 2 recorded values a day.

Obtain at least 29 values per quality control level.

Calculate the mean for each quality control level/analyte combination.

Verify that the calculated mean is within the manufacturer assigned range provided in the quality control reagent instructions for use (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 quality control level.

• If the mean is not within the assigned range, contact Technical Support.

• If no manufacturer assigned ranges are listed in the reagent instructions for use, contact Technical Support.

1

2

3

4

5


7.6: Quality Control Worksheet Access 2 Operator’s Guide

7.6Quality Control Worksheet

After you set up the quality controls for the Access 2 instrument, you can record the setup information on the Quality Control Worksheet. You can use the worksheet on the following page as an original and make photocopies for use on each Access 2 instrument. Keep the worksheet, along with the any others, in one place that can be referenced in the future.


Access 2 Operator’s Guide 7.6: Quality Control Worksheet

Quality Control Worksheet

0784a.bmp

Figure 7-23 Quality Control Worksheet

Quality Control Name/ Level

Lot No. Exp. Date TypeTest ID/ Name

Mean SD QC Rules Applied

12s 22s 13s 41s 10x


7.6: Quality Control Worksheet Access 2 Operator’s Guide


Access 2 Operator’s Guide 8: Routine Maintenance

8Routine Maintenance

8.1 Routine Maintenance ...................................................................................8-3

Maintenance Review Screen .............................................................................8-5

Running the Utility Assay.................................................................................8-6

Enabling/Disabling the Utility Assay ...............................................................8-8

Requesting Maintenance Routines....................................................................8-8

Maintenance Requests Screen......................................................................... 8-11

8.2 Daily Maintenance......................................................................................8-14

Daily Maintenance Required Materials .......................................................... 8-16

Checking the System Status ............................................................................ 8-18

Inspecting the Fluidic Module ........................................................................ 8-19

Cleaning the Wash Carousel Probe Exteriors ................................................. 8-20

Priming the Substrate ......................................................................................8-23

Running the Daily Clean System Routine ...................................................... 8-24

8.3 Weekly Maintenance ................................................................................. 8-27

Weekly Maintenance Required Materials.......................................................8-29

Cleaning the Instrument Exterior .................................................................... 8-30

Inspecting the Liquid Waste Bottle for Wear ................................................. 8-30

Checking for Fluid in the Waste Filter Bottle................................................. 8-31

Inspecting and Cleaning the Primary Probe.................................................... 8-32


8: Routine Maintenance Access 2 Operator’s Guide

Replacing the Aspirate Probes ........................................................................ 8-35

Cleaning the Aspirate Probes .......................................................................... 8-38

Running Daily Maintenance ........................................................................... 8-44

Running System Check ................................................................................... 8-44

8.4 System Check ..............................................................................................8-45

System Checks Screen .................................................................................... 8-46

System Check Data Screen ............................................................................. 8-48

Viewing and Printing System Check Result Data .......................................... 8-50

System Check Required Materials .................................................................. 8-53

Running the System Check Routine ...............................................................8-53

System Check Expected Results ..................................................................... 8-56

8.5 Special Clean ............................................................................................... 8-57

Special Clean Routine Required Materials ..................................................... 8-59

Running the Special Clean Routine ................................................................ 8-59

8.6 Maintenance Log ........................................................................................ 8-62


Access 2 Operator’s Guide 8.1: Routine Maintenance

8.1Routine Maintenance

For optimal performance, the Access 2 system requires routine maintenance. Routine maintenance includes: Daily Maintenance, Weekly Maintenance, and the Utility Assay.

Daily maintenance includes inspection, cleaning, and priming procedures that you perform once every 24 hours. Weekly maintenance includes more cleaning procedures and the System Check routine. You perform the System Check routine as part of weekly maintenance to verify system performance. You can also run the System Check routine to troubleshoot the system.

The Utility Assay runs automatically every four hours when the system is not processing samples, and after the instrument finishes running the samples in the last on-board rack. You can also run the Utility Assay manually, when requested by Technical Support.

You can use the Maintenance Log as a checklist for performing all routine maintenance procedures. Keep the Maintenance Log in this chapter as an original and make photocopies for use with each Access 2 system in your laboratory. Retain the completed Maintenance Logs for reference.

Special Clean is a supplemental cleaning routine that may be performed when requested by Technical Support or required for troubleshooting. Special Clean deep cleans the instrument probes and fluidic lines to prevent contamination of future tests from debris.

A technical support representative will schedule periodic preventive maintenance procedures on your Access 2 instrument in accordance with the terms of your service agreement, if applicable. For more information about preventive maintenance, contact Technical Support.

For instructions on running the Utility Assay manually, see the Running the Utility Assay procedure in this section.


8.1: Routine Maintenance Access 2 Operator’s Guide

For troubleshooting information, see Appendix A: Troubleshooting in the Reference

Manual.

The original version of the maintenance log is in this chapter, see Section 8.6: Maintenance Log.



Maintenance Review ScreenUse the Maintenance Review screen to:

• Check the temperatures of thermal zones and substrate

• Run the Utility Assay

• Disable the Utility Assay

• Display the System Checks screen

• Print the Temperature Report

To get to this screen from the Main Menu, select Maintenance Review F6.

0775C.bmp

Figure 8-1 Maintenance Review Screen



Running the Utility Assay

The Utility Assay runs automatically or manually to clean the interior of the aspirate and dispense probes.

The Utility Assay runs automatically:

• After the instrument finishes running the samples in the last on-board rack. This feature cannot be disabled.

• Every four hours, when the instrument is not processing samples. This feature can be disabled (see the Enabling/Disabling the Utility Assay

Zone Temperature (deg C)

(Fields) Displays the following temperatures in degrees Celsius:

• Incubator

• Wash Carousel

• Substrate

• Refrigerator

• Instrument Case

The temperatures are updated in real-time.

Limits (Fields) Displays the expected incubator, wash carousel, substrate, and refrigerator temperature ranges in degrees Celsius.

System Checks F2 (Button) Select to display the System Checks screen (see Figure 8-26). Use this screen to:

• View the results of up to 50 System Checks

• Display the System Check Data screen

Run Utility Assay F5 (Button) Select to run the Utility Assay. You run the Utility Assay as requested by Technical Support or as required for troubleshooting. The Utility Assay cleans the main pipettor, aspirate, and dispense probes (see the Running the Utility Assay procedure in this section). The system displays a message while the Utility Assay is running.

Disable/Enable Utility Assay F6

(Button) Select to disable and enable the automatic Utility Assay. When the Utility Assay is enabled, it runs every four hours that the instrument is not processing samples.

Print F7 (Button) Select to print the Temperature Report, which shows the temperatures, duty cycle, and status from the Analog Devices window (see Section 5.6: Analog and Digital Device Diagnostics in the Reference Manual). You can also print the Temperature Report from the Diagnostics menu.

For an example, see Section 5.10: Diagnostic Reports in the Reference Manual.

Table 8-2 Maintenance Review Screen Descriptions



procedure in this section).

NOTE

If you will not be using the instrument to process samples for a long period of time, be sure that you load enough RVs on the system so the Utility Assay can continue to run. The Utility Assay runs every four hours, and uses three RVs each time it runs. To calculate the number of RVs needed, use the following formula:

0922A.wmf

You can run the Utility Assay manually when additional cleaning is requested by Technical Support or required for troubleshooting. Use this procedure to run the Utility Assay manually.

Be sure the system is in the Ready mode. Go to the Maintenance Review screen. To get to this screen from the Main Menu, select Maintenance Review F6 (see Figure 8-1).

Select Run Utility Assay F5.

Select Yes F1.

The system enters the Running mode.

NOTES

• In the Event Log, the system records that the run has started.

• You can perform other tasks while the Utility Assay is running, including loading racks and most supplies.

Hours not processing samples4 (hours) = Utility Assay repetitions * 3 (RVs) = Number of RVs needed

For example:

50 (hours)4 (hours)

= 12 * 3 = 36

Be sure 36 RVs are loaded on the instrument.

1

2

3



Enabling/Dis-abling the Utility Assay

Use this procedure to disable the Utility Assay. Disabling the Utility Assay prevents it from running every four hours that the instrument is not processing samples.

WARNINGDisable the Utility Assay while you are working on the instrument for extended periods of time to prevent injury from the instrument accidentally starting up.

Go to the Maintenance Review screen. To get to this screen from the Main Menu, select Maintenance Review F6 (see Figure 8-1).

Select Disable Utility Assay F6.

To restart the timer for the Utility Assay, select Enable Utility Assay F6.

Requesting Maintenance Routines

Use this procedure to request maintenance routines. You can request and load maintenance routines while the system is processing patient samples. The maintenance routines run after the system completes the on-board patient samples.



Be sure that the Rack ID field is selected, then type the rack ID and press [Enter].

The rack must have a rack ID between 1-57 or 400-456.

The new rack is displayed in the Off Board list on the Sample Manager screen.

Select Maintenance Request F4.

The Request Maintenance window is displayed over the Maintenance Requests screen (see Figure 8-3).

NOTE

When you select Maintenance Request F4, the Sample Manager screen is no longer displayed.

1

2

1

2

3



Select a maintenance routine in the Request Maintenance routine window. You can select Daily Clean System, Special Clean, or a System Check routine.

You can run the routines separately, or you can run System Check with the Daily Clean System or the Special Clean routine. Special Clean contains the Daily Clean System routine; therefore, you cannot select these routines at the same time.

NOTES

• If you select Daily Clean System or Special Clean and a System Check, the system runs the Daily Clean System or Special Clean routine before the System Check.

• When you run the System Check or Special Clean routine, the system records it in the Event Log.

0667A.bmp

Figure 8-3 Request Maintenance Window

Daily Clean System (Option) Select to run the Daily Clean System mainte-nance routine. The Daily Clean System routine cleans the interior of the primary, dispense, and aspirate probes and primes the wash buffer lines (see the Running the Daily Clean System Routine procedure in this section).

Table 8-4 Request Maintenance Window Descriptions

4



Select OK F1.

The system displays the requested routine, sample types, completion time, and status on the Maintenance Requests screen (see Figure 8-5).

NOTE

The completion time is updated when Run is selected in step 8.

Select Load Rack X F1. (The X represents the number of the rack that you entered into the Rack ID field on the Sample Manager screen.)

The system displays the Load Rack window and the instrument moves the sample carousel into position for loading.

NOTE

Load the rack after requesting the maintenance routine. If you load the rack first, the system recognizes the rack as a patient sample rack, and will not accept the maintenance request. If the rack is already loaded, take the rack off board, clear it, and load it again after requesting the maintenance routine.


For more information on loading a rack, see Section 3.1: Sample Management.

Special Clean (Option) Select to run the Special Clean maintenance routine. Perform the Special Clean routine at the end of the day if the Access 2 system is processing the Vitamin B12 assay.

For more information about running the Special Clean routine, see Section 8.5: Special Clean.

No Clean (Option) Select to clear the Daily Clean System and the Special Clean options.

System Check (Box) Select to run the System Check maintenance rou-tine. You run the System Check routine as part of weekly maintenance or for troubleshooting (see the Running the System Check Routine procedure in Section 8.4: System Check).

(List) Select a System Check maintenance routine from the list. Values are: None, All, Washed, Unwashed, and Substrate.

You can run the individual system checks for trouble-shooting purposes. For more information, see Chapter 5.11: Individual System Checks in the Reference Manual.

Table 8-4 Request Maintenance Window Descriptions (continued)

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7



WARNINGS• Unless there is an emergency, let the maintenance routine run to completion.

Cancelling the routine may damage the instrument and compromise the integrity of subsequent test results.

• If you cancel the routine, do not initialize the system. Contact Technical Support for assistance.

Select Run.

When the maintenance routine is complete, unload the rack and select Done F1.

For more information on unloading a rack, see Section 3.1: Sample Management.

Maintenance Requests ScreenUse the Maintenance Requests screen to:

• View the contents of the sample cups that are on board a rack

• Monitor the status of the maintenance routines entered into the system

• Edit a requested maintenance routine

• Load a rack

To get to this screen from the Main Menu, select Sample Manager F1 to display the Sample Manager screen, then

Select a rack (must have a rack ID between 1-57 or 400-456) that contains a previously requested maintenance routine from the On Board or Off Board list, then

Select Maintenance Request F4 to display the Request Maintenance window, then

Select the maintenance routines to run and select OK F1.

NOTE

To get to the Maintenance Requests screen by entering a new rack, see the Requesting Maintenance Routines procedure in this section.

8

9



0668B.bmp

Figure 8-5 Maintenance Requests Screen

Rack Location Rack StatusRack ID Rack IconPosition

Rack Icon (Indicator) Displays the rack ID and position of each sample cup in the rack.

If any of the following errors occur after loading, the system turns the affected sample cup red:

• The sample cup is missing

• There is not enough sample to complete one or more tests

Rack ID (Field) Displays the ID of the rack selected on the Sample Manager screen. If you want to change the selected rack, you must go back to the Sample Manager screen, select a different rack, then select Maintenance Request F4.

Rack Location (Field) Displays the location of the rack.

Values are: Scanned/Loaded or Unloaded.

Table 8-6 Maintenance Requests Screen Descriptions



Rack Status (Indicator) Displays the sample processing status for the rack as determined by the least processed sample in the rack.

Values are: No Tests, Requested, Supply Wait, In Progress, Aspirated, Done, and *Done*.

For more information about rack statuses, see Section 4.4: Monitoring Sample Progress in this manual.

Position (Icon) Shows the samples in rows numbered 1-10. The rows correspond to the ten positions in the selected rack, from left to right with the convex side of the rack facing you.

The fields in each sample position row pertain to the sample in that position in the rack.

Routine (Field) Displays the name(s) of the maintenance routine(s) being run.

Values are: Daily Clean System, Special Clean, and System Check.

If you select individual system checks, System Check appears in the Routine field.

Sample Type (Field) Displays the contents and quantity of each sample cup needed in the rack, according to the requested maintenance routines.

Completion (Field) Displays the estimated time the system will finish processing the tests requested for the sample. The format of this field is defined when you configure the system. For more information, see Chapter 4: System Configuration in the Ref-erence Manual.

For Special Clean and Daily Clean System, the completion time is for the entire rack. For System Check, the completion time is shown for each part of the routine.

Status (Field) Displays the sample status, as determined by the least processed test requested for the sample.

Values are: No Tests, Requested, Supply Wait, In Progress, Aspirated, Done, *Done*, and QNS (sample quantity not sufficient).

If the system cancels a test, it records the test name and sample ID on the Event Log screen and the Event Log button turns red.

Load/Get Rack X F1 (Button) X is the rack ID of the rack selected on the Sample Manager screen. If the selected rack is off board, select Load Rack X to load it. If the selected rack is on board, select Get Rack X to present the rack at the sample carousel door, where you can add, remove, or rearrange samples, or you can unload the rack

Edit Request F2 (Button) Select to display the Request Maintenance window. Use this window to change the selected maintenance routines.

Maintenance Review F6

(Button) Select to display the Maintenance Review screen (see Figure 8-1).

Table 8-6 Maintenance Requests Screen Descriptions (continued)


8.2: Daily Maintenance Access 2 Operator’s Guide

8.2Daily Maintenance

In order to keep the Access 2 system running properly, perform daily maintenance once every 24 hours. Daily maintenance is made up of the following procedures, performed in sequence:

Check the System Status

Inspect the Fluidic Module

Clean the Wash Carousel Probe Exteriors

Prime the Substrate

Run the Daily Clean System Routine

NOTES

• If you use the Access 2 system to process the Vitamin B12 assay, you should also run the Special Clean routine at the end of every day or whenever the instrument will not process samples for 8 hours or more, see Section 8.5: Special Clean.

• If the system is not used to run assays every day, it is still important to perform daily maintenance on schedule to ensure that the system is ready when needed.

For an overview of daily maintenance, see Figure 8-7.

1

2

3

4

5


Access 2 Operator’s Guide 8.2: Daily Maintenance

0787C.wmf

Figure 8-7 Daily Maintenance Flowchart

PC Admin

Check theBackup*

Inspect theFluidic Module*

Clean theWash CarouselProbe Exteriors*

Main Menu


Main Menu

DiagnosticsF7

Prime FluidicsF2

Prime Fluidics

Prime the Substrate*

Maintenance Review

Check theZone Temperatures*

Sample Manager

Maintenance RequestsF4

Maintenance Request

Request Maintenance

Run the DailyClean System*

* Initial the Maintenance Log

Check the Suppliesand WasteContainers*

Main Menu

ConfigureF8

PC AdminF7

Main Menu

Sample ManagerF1

OKF1

CheckSystemStatus

Place cups in rack

Load the rack

Run



Daily Maintenance Required Materials

You need to gather the following materials to perform daily maintenance. This is the complete list of materials for all of the procedures. For a list of part numbers and for ordering information, see the instrument Instructions for Use.



• Citranox cleaning solution is acidic and may cause eye or skin irritation. See the manufacturer’s label for details.

• Contrad 70 cleaning solution is alkaline and may cause severe eye irritation or mild skin irritation. See the manufacturer’s label for details.

• Wash buffer contains ProClin 300 preservative, which may cause sensitization by skin contact. After contact with skin, wash immediately with soap and water. Wear suitable gloves.

• Fiber-free polyester swabs (or equivalent fiber-free applicators)

• Maintenance Log (see Section 8.6: Maintenance Log)

• 13 mm rack for 2 mL sample cups; the rack must have a rack ID between 1-57 or 400-456

• Wash buffer (or deionized water)

• Citranox* cleaning solution

• Contrad** 70 cleaning solution

• 2.0 mL sample cups (three cups)

NOTE

Use only the 2.0 mL sample cups when performing the maintenance routines. Using any other sample containers may result in level sensing errors and cancellation of the maintenance routine.

* Citranox is a trademark of Alconox, Inc.** Contrad is a trademark of Decon Laboratories, Inc.



0592C.wmf

Figure 8-8 Daily Maintenance: Checking the System Status Flowchart

Main Menu


Temperaturesin range?

Yes*

Suppliesand waste containers

OK?

Complete the remaining Daily Maintenance

procedures

* Initial the Maintenance Log.

Backup Successful?

Yes*

NoContact

Technical Support

Correct Supply ConditionNo

SuppliesFor information on adding supplies and changing waste containers,see Chapter 2: Supplies.

Perform ImmediateSystem BackupNo

System ConfigurationFor information on system backups, see Chapter 4: System Configuration in the Reference Manual.

PC Admin

Verify the backup status

Maintenance Review

Check Zone Temperatures

Main Menu

ConfigureF8

PC AdminF7

Yes*



Checking the System Status

Use this procedure to check the system status (see Figure 8-8).

Go to the Maintenance Review screen. To get to this screen from the Main Menu, select Maintenance Review F6.

Verify that the temperatures in the Zone Temperature (Degrees Celsius) fields are within their expected ranges displayed on the Maintenance Review screen.

Out-of-range temperatures are displayed in red. If a temperature is out of range, contact Technical Support for assistance.

(Optional) Replenish the supplies and change the waste containers if the system status buttons are red or yellow (see Chapter 2: Supplies).

For printer supplies, see the documentation that came with your printer.

NOTE

Frequent emptying of the waste bottle may extend its service life.

Go to the PC Admin screen on the server system. To get to this screen from the Main Menu, select Configure F8, then PC Admin F7.

Verify that the system backup was successful. For more information, see the Scheduling System Backups procedure in Section 4.10: PC Administration Setup of the Reference Manual.

NOTE

Depending on your laboratory’s schedule, the system backup may or may not run daily.

(Optional) If the system backup was not successful, perform an immediate system back up. For more information, see the Scheduling System Backups procedure in Section 4.10: PC Administration Setup of the Reference Manual.

Initial the appropriate sections of the Maintenance Log (see Section 8.6: Maintenance Log).

1

2

3

4

5



0593Cwmf

Figure 8-9 Daily Maintenance: Inspecting the Fluidic Module Flowchart

Inspecting the Fluidic Module

Use this procedure to visually inspect the fluidic module (see Figure 8-9).


Be sure that the system is in the Ready or Not Ready mode.

Open the front panel of the instrument. To open the front panel, gently pull the bottom of the panel toward you, then lift upward.

Visually inspect all accessible tubing connections and valve and pump fittings for crystalline buildup or corrosion.

If you find crystalline buildup or corrosion, contact Technical Support for assistance. Deposits indicate that a connection or fitting may be leaking.

Close the front panel of the instrument.

Initial the appropriate section of the Maintenance Log.

Is there buildup or corrosion?

ContactTechnical Support

InitialMaintenance Log

Open front panel

Inspect fluidic module for crystalline buildup or

corrosion

No

Yes

1

2

3

4

5



0594A.wmf

Figure 8-10 Daily Maintenance: Cleaning the Wash Carousel Probe Exteriors Flowchart

Cleaning the Wash Carousel Probe Exteriors

Use this procedure to clean the exterior of the substrate, dispense, and aspirate probes.


CAUTIONS

• Be sure not to bend or damage the fragile probe tips.

• To avoid contamination, use a new swab on each type of probe.

• Do not wipe the tip of the probe. Fibers on or inside the probes can clog the probes or valves in the fluidic module.



Locate the substrate, dispense, and aspirate probes (see Figure 8-11).

Clean substrateprobe exterior with

deionized water

Clean dispenseprobe exteriors with

deionized water

Clean aspirateprobe exteriors with

deionized water


Close front panel

1

2

3



0195H.eps

Gently wipe the exterior of the substrate probe with a new, fiber-free polyester swab moistened with wash buffer (or deionized water).

Gently wipe the exterior of the dispense probes with a new, fiber-free polyester swab moistened with wash buffer (or deionized water).

Gently wipe the exterior of the aspirate probes with a new, fiber-free polyester swab moistened with wash buffer (or deionized water).

NOTE

You do not need to clean the exterior of the aspirate probes if you are performing weekly maintenance, and you have already installed clean aspirate probes.

1 Dispense Probe 1 (Probe #1)

2 Aspirate Probe 1 (Probe #2)





7 Substrate Probe (Probe #7)

Figure 8-11 Dispense, Aspirate, and Substrate Probes

1

2345

67

6

7

45

1

23

4

5

6





0595A.wmf

Figure 8-12 Daily Maintenance: Priming the Substrate Flowchart

7

8

The system primesthe substrate(5 minutes)


Wait until the status barindicates the priming

is complete

Main Menu

DiagnosticsF7

Prime FluidicsF2

CancelF8

Prime Fluidics

Select Substrate

Start PrimingF2



Priming the Substrate

Use this procedure to prime the substrate fluidic lines (see Figure 8-12). The priming sequence takes about 8 minutes.

Go to the Prime Fluidics window. To get to this window from the Main Menu, be sure the system is in the Ready mode, then

Select Diagnostics F7 to display the Diagnostics menu, then

Select Prime Fluidics F2 (for more information, see Section 5.3: Prime Fluidics in the Reference Manual).

Select the Substrate box.

(Optional) Select the Cycles field to change the number of times the system primes the substrate.

Select Start Priming F2.

The system primes the substrate and displays messages about the progress of the routine.

NOTE

When the substrate is priming, Start Priming F2 changes to Stop Priming F2.

(Optional) Select Stop Priming F2 to stop priming in an emergency.

When priming is complete, select Cancel F8 to return to the Main Menu.


1

2

3

4

5



0596B.wmf

Figure 8-13 Daily Maintenance: Running the Daily Clean System Routine Flowchart

Running the Daily Clean System Routine

Use this routine to clean the interior of the primary, dispense, and aspirate probes and to prime the wash buffer lines (see Figure 8-13). In addition to running this routine during daily maintenance, you should also run this routine if you know that the

Sample Manager

Enter the Maintenance RackNumber in the Rack ID field

Main Menu

Sample ManagerF1

Maintenance RequestF4

Load rack

The system cleansprobe interiors(15 minutes)

Unload rack

Wait until the status barindicates the cleaning

is complete

Initial theMaintenance Log

Maintenance Requests

Load RackF1

Request Maintenance

Select Daily CleanSystem

Run

Complete the remainingDaily Maintenance

routines

OKF1

Place 2.0 mL samplecups in rack positions

1, 2, and 3

Pipette 2.0 mLContrad 70 into cup 1

Pipette 2.0 mL1/5 Citranox/deionizedwater dilution into cup 2

Pipette 2.0 mLdeionized wateror wash buffer

into cup 3



instrument will not process samples for an extended time period. Once you prepare and load the rack, the Daily Clean System routine takes about 15 minutes to run.


NOTES

• When you are performing the weekly maintenance routines, the Daily Clean System routine is run with the System Check routine.

• Load the rack after requesting the maintenance routine. If you load the rack first, the system recognizes the rack as a patient sample rack, and will not accept the maintenance request. If the rack is already loaded, take the rack off board, clear it, and load it again after requesting the maintenance routine.

• You can request and load maintenance routines while the system is processing patient samples.

Go to the Sample Manager screen. To get to this screen from the Main Menu, select Sample Manager F1 (see Section 3.1: Sample Management).





NOTE


Select the Daily Clean System option.

Select OK F1.

The system displays the requested routine, sample types, completion time, and status on the Maintenance Requests screen.

NOTE

The completion time is updated when Run is selected in step 12.

Place the 2.0 mL sample cups in sample positions 1, 2, and 3 of an empty rack.

1

2

3

4

5

6



Pipette 2.0 mL of Contrad 70 cleaning solution into the sample cup in position 1.

Pipette 2.0 mL of a 1/5 dilution of Citranox cleaning solution (mix 1 part Citranox cleaning solution and 4 parts deionized water) into the sample cup in position 2.

Pipette 2.0 mL of wash buffer (or deionized water) into the sample cup in position 3.

Select Load Rack X F1. (The X represents the number of the rack that you entered into the Rack ID field on the Sample Manager screen.)


The system displays a message and presents a rack position.


For more information on loading a rack, see Section 3.1: Sample Management.




Select Run.

NOTE

The Daily Clean System routine runs after the system completes the on-board patient samples.

When the Daily Clean System routine is complete, unload the rack and select Done F1.



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10

11

12

13

14


Access 2 Operator’s Guide 8.3: Weekly Maintenance

8.3Weekly Maintenance

In order to keep the Access 2 system running properly, perform weekly maintenance once every seven days. Weekly maintenance is made up of the following procedures, performed in sequence:

Clean the Instrument Exterior

Inspect the Liquid Waste Bottle for Wear

Check for Fluid in the Waste Filter Bottle

Inspect and Clean the Primary Probe

Replace the Aspirate Probes

Clean the Aspirate Probes

Run Daily Maintenance (for more information, see Section 8.2: Daily Maintenance in this chapter)

Run System Check (for more information, see Section 8.4: System Check in this chapter)

NOTE

If the system is not used to run assays every day, it is still important to perform weekly maintenance on schedule to ensure that the system is ready when needed.

1

2

3

4

5

6

7

8


8.3: Weekly Maintenance Access 2 Operator’s Guide

0808C.wmf

Figure 8-14 Weekly Maintenance Flowchart

Check for Fluid in the Waste Filter Bottle*

Inspect and Clean the Primary Probe*

Replace and Clean the Aspirate Probes*

Run DailyMaintenance*

Inspect the Liquid Waste Bottle for Wear*

Remove the Aspirate ProbesInstall Clean ProbesClean the Removed Probes

Run System Check*

* Initial Maintenance Log

Clean the Instrument Exterior*

DiscolorationCracking or CrazingBulging



Weekly Maintenance Required Materials

You need to gather the following materials to perform weekly maintenance. This is the complete list of materials for all of the procedures. For a list of part numbers and for ordering information, see the instrument Instructions for Use.

WARNINGS• Methanol is extremely flammable. Do not use near heat or flame. Do not

ingest. Avoid contact with eyes, skin, and clothing. Use with adequate ventilation.



• Lint-free cloth

• Deionized or distilled water


• Spare liquid waste bottle (as needed)

• Spare waste filter bottle (as needed)

• Alcohol or alcohol swabs or wipes (methanol can be substituted for cleaning the exterior of the aspirate probes)

• Proper hand, eye, and facial protection for handling biohazardous materials

• Clean aspirate probes (three)

• Contrad 70 cleaning solution

• Beakers (two)

• Aspirate Probe Cleaning Kit (3.0 mL syringe, disposable aspirate probe brush, aspirate probe syringe fitting assembly consisting of a fitting and tubing)

• Disposable aspirate probe brushes (as needed)

• Absorbent paper

• Wash buffer



Cleaning the Instrument Exterior

Use this procedure to clean the exterior of the system.

Moisten a clean, lint-free cloth with deionized water (or distilled water).

Wipe the exterior of the instrument with the moistened cloth.


Inspecting the Liquid Waste Bottle for Wear

Use this procedure to inspect the liquid waste bottle for wear. Over time, the waste bottle can degrade, become brittle, and potentially crack. Any defect that is not removed by routine cleaning is a sign of deterioration. If you detect any issues with the waste bottle, replace the waste bottle with a clean spare bottle and discard the old bottle.


New bottles are opaque white in color. Look for color change to the bottle (yellow, orange, or pink), which is a sign of deterioration. Replace the bottle as needed.

Inspect the area nearest the handle and along all seams of the bottle for cracking or crazing (spider web cracking), which are signs of deterioration. Replace the bottle as needed.

Look for bulging of the waste bottle. If you detect bulging, contact Technical Support to discuss the inspection findings and any further action.


1

2

3

1

2

3

4



0600A.wmf

Figure 8-15 Weekly Maintenance: Checking for Fluid in the Waste Filter Bottle Flowchart

Checking for Fluid in the Waste Filter Bottle

Use this procedure to check the waste filter bottle for fluid.


Inspect the waste filter bottle for fluid collecting in the bottom.

(Optional) If fluid is visible, replace the waste filter bottle (see the Replacing the Waste Filter Bottle procedure in Section 7.4: Fluids Tray and Instrument Base Procedures of the Reference Manual).


Waste filterbottle empty?


Yes

Replace waste filterbottle

Inspect waste filterbottle for fluid

No

1

2



0599C.wmf

Figure 8-16 Weekly Maintenance: Inspecting and Cleaning thePrimary Probe Flowchart

Inspecting and Cleaning the Primary Probe

A bent, damaged, or dirty primary probe can lead to level sensing errors. During weekly maintenance, visually inspect the primary probe for damage before cleaning the probe exterior. Use this procedure to inspect the primary probe and clean the probe exterior.


Is therebuildup?

Clean primary probeexterior with alcohol

Yes


Open front panel

Inspect primaryprobe for

crystalline buildup

Visually inspect primaryprobe for damage

Is the probeundamaged?

Yes

No Replace primary probe

No





Visually inspect the primary probe. If the probe is bent or damaged, replace the primary probe. For more information about replacing the probe, see Section 7.6: Main Pipettor Procedures in the Reference Manual.

Inspect the upper portion of the primary probe for crystalline buildup (see Figure 8-17).

0161B.eps

(Optional) If you see crystalline buildup, carefully wipe the upper portion of the primary probe with an alcohol swab or a lint-free cloth dampened with alcohol.

CAUTION

Do not wipe the tip of the probe. Fibers on or inside the probes can clog the probes or valves in the fluidic module.



1 Upper Portion of Primary Probe

Figure 8-17 Primary Probe

1

2

3

4

!

1

5

6



0776C.wmf

Figure 8-18 Weekly Maintenance: Replacing the Aspirate Probes Flowchart

Clean theprobes within

one hour?

Clean the removedaspirate probes

Soak the probes indistilled water

Remove the aspirateprobe from the

wash arm

Disconnect the probetubing from thebarbed fitting

Repeat for theother two probes

Open the front paneland top cover

No

Yes

Close the front paneland top cover

Install a cleanaspirate probe

Turn theinstrument off

Turn theinstrument on




Replacing the Aspirate Probes

Use this procedure to replace the aspirate probes.

Removing the Aspirate Probes



• You must shut the instrument off while replacing the aspirate probes.


Turn the instrument off by pressing the lower part of the power switch to off (O position). For an illustration, see Figure 7-8 in the Reference Manual.

Open the front panel and top cover of the instrument.

For more information about how to open and close the top cover, see the Opening and Closing the Top Cover procedure in Section 7.2: Instrument Cover Procedures of the Reference Manual.

Locate the aspirate probes (see Figure 8-19).

0152Ic.eps

1 Black Probe Retainers

2 Barbed Fittings

3 Wash Arm




Figure 8-19 Aspirate Probes

1

2

3

4

1

2345

61

6 45

2 3



NOTE

There are seven probes on the wash arm: three wash buffer dispense probes, three aspirate probes, and one substrate dispense probe. The probe positions are numbered sequentially from RIGHT to LEFT. If you cannot identify the correct probes, contact Technical Support.

Gently grasp a black aspirate probe retainer above the wash arm. Gently push down on the retainer, then rotate it 1/4 turn counterclockwise.

CAUTION

Handle the aspirate probes with extreme care. The probes are fragile, and will not function properly if bent.

While holding the probe by the black probe retainer, lift up to remove the probe from the wash arm. Be careful not to bend the probe.

At the barbed fitting, grasp and pull the aspirate probe tubing until it separates from the fitting. The tubing will stretch (see Figure 8-20).

0153dC.eps

Install a clean aspirate probe (see the Installing Clean Aspirate Probes procedure in this section).

Repeat step 5 through step 8 to remove and install the other two aspirate probes.

1 To Waste Pump or Waste Valve

2 Separate Here

3 To Aspirate Probe

4 Barbed Fitting

Figure 8-20 Disconnecting Aspirate Probe Tubing at the Barbed Fitting

5

6

7

4

1

2

3

8

9


(Optional) If you want to clean the removed probes now, perform the Cleaning the Aspirate Probes procedure. Then perform the Installing Clean Aspirate Probes procedure.

(Optional) If you do not plan to clean the removed probes within one hour, place them in distilled water.

Installing Clean Aspirate Probes

NOTE

You can either install clean aspirate probes from a supply of probes in the CARE kit, or clean the removed probes and reinstall them on the instrument.

Push the aspirate probe tubing onto the barbed fitting of a clean aspirate probe, being careful not to damage the barbed fitting or probe assembly. Be sure that the tubing is pushed all the way to the barbed fitting collar.

If the tubing is not flush against the collar, the wash system may be adversely affected.

0799B.eps

Route the tubing under both the clear, rigid pipettor tubing and the wiring located to the left of the pipettor gantry.

1 Aspirate Probe Tubing

2 Barbed Fitting

3 Barbed Fitting Collar

Figure 8-21 Aspirate Probe Tubing and Barbed Fitting

1

1

2

3

2



From the top of the wash arm, carefully route the clean probe down through the opening in the wash arm. Rotate the black probe retainer until the two tabs engage the slots in the wash arm.

While holding the probe by the black probe retainer, gently push down on the retainer and then turn it 1/4 turn clockwise.

Lift gently on the probe tubing to be sure the probe moves up and down.

Repeat step 1 through step 5 to install the other two aspirate probes.

Close the front panel and top cover of the instrument.

For more information about how to open and close the top cover, see the Opening and Closing the Top Cover procedure in Section 7.2: Instrument Cover Procedures of the Reference Manual.

(Optional) Reorder any CARE kit parts that you use. For ordering information, see the instrument Instructions for Use.

Turn the instrument on by pressing the upper part of the power switch to on (| position). For an illustration, see Figure 7-6 in the Reference Manual.

Cleaning the Aspirate Probes

Use this procedure to clean the aspirate probes.



• Once a disposable aspirate probe brush has been used to clean 1 to 3 aspirate probes, it is considered a biohazard. Handle and dispose of the brush according to appropriate laboratory safety procedures. Do not save a used brush for future use.

• Methanol is extremely flammable. Do not use near heat or flame. Do not ingest. Avoid contact with eyes, skin, and clothing. Use with adequate ventilation.


3

4

5

6

7

8



CAUTIONS

• Handle the aspirate probes with extreme care. The probes are fragile, and will not function properly if bent.

• The disposable aspirate probe brush handle bends easily.

NOTE

Always keep a spare set of new or previously cleaned aspirate probes in the CARE kit. During weekly maintenance, remove the aspirate probes and replace them with the spare set from the CARE kit. Clean the removed probes and store them in the CARE kit for the next time you perform the weekly maintenance procedures. For information about ordering replacement probes, see the instrument Instructions for Use.

0818a.wmf

Figure 8-22 Weekly Maintenance: Precleaning the Aspirate Probes Flowchart

Precleaning the Aspirate Probes

Fill a small beaker with approximately 20 mL of Contrad 70 cleaning solution.

Fill another small beaker with approximately 50 mL of deionized water.

Insert and remove theprobe brush in the

probe until all of theresidue is removed

Fill a beaker with 50 mLof deionized water

Dip a new aspirateprobe brush into the

Contrad 70

FIll a beaker with 20 mLof Contrad 70

Repeat for the othertwo aspirate probes

1

2



Dip the aspirate probe brush in the undiluted Contrad 70 cleaning solution.

Carefully insert the aspirate probe brush into the bottom end of the aspirate probe and push it in until the brush tip protrudes slightly from the other end of the probe.

WARNINGTake the necessary precautions when removing and reinserting the probe brush to avoid scattering droplets of biohazardous material into the air.

Remove the brush.

Repeat step 3 through step 5 several times on the same probe, or until no orange residue is visible on the brush after removing it from the probe.

Repeat step 3 through step 6 for the other two aspirate probes.

Clean the probes with Contrad 70 cleaning solution (see the Cleaning the Aspirate Probes with Contrad 70 Cleaning Solution procedure in this section).

3

4

5

6

7

8



0819a.wmf

Figure 8-23 Weekly Maintenance: Cleaning the Aspirate Probes with Contrad 70 Cleaning Solution Flowchart

Assemble the syringe

Attach the probe to thesyringe

Draw the Contrad 70into the syringe

Empty the syringe intothe beaker

Remove the probe fromthe syringe

Repeat for the othertwo aspirate probes

Rinse the probe bydrawing Contrad 70 into

the syringe; empty itinto the beaker



Cleaning the Aspirate Probes with Contrad 70 Cleaning Solution

Attach the syringe fitting assembly onto the syringe (see Figure 8-24).

0400E.eps

Draw the Contrad 70 cleaning solution into the syringe.

Push the plastic barbed fitting of the aspirate probe into the open end of the tubing on the syringe fitting assembly.

Empty the syringe, forcing the Contrad 70 cleaning solution through the aspirate probe and back into the beaker.

Flush the probe again by drawing the Contrad 70 cleaning solution into the syringe through the aspirate probe and then emptying the syringe through the probe into the beaker.

Remove the aspirate probe tubing from the syringe fitting assembly.


Clean the probes with distilled water (see the Cleaning the Aspirate Probes with Distilled Water procedure in this section).

1 Syringe

2 Syringe Fitting Assembly

Figure 8-24 Attaching Syringe Fitting Assembly

1

1

2

2

3

4

5

6

7

8



0778a.wmf

Figure 8-25 Weekly Maintenance: Cleaning the Aspirate Probes with Distilled Water Flowchart

Repeat for the othertwo probes

Initial theMaintenance Log

Clean the exteriorof the probewith alcohol

Position the probe onabsorbent paper for10 minutes to drain

Draw the distilled waterinto the syringe

Attach the probe to thesyringe

Empty the syringeinto a sink

Rinse the probe twiceby drawing water intothe syringe; empty it

into a sink

Remove the probe fromthe syringe



Cleaning the Aspirate Probes with Distilled Water

Draw distilled water from the beaker into the syringe.

Attach the aspirate probe tubing to the syringe fitting assembly.

Empty the syringe, forcing the water through the aspirate probe tubing and into a sink.

Rinse the probe three more times by drawing water from the same beaker into the syringe through the aspirate probe, and then emptying the syringe through the probe into a sink.

Remove the aspirate probe tubing from the syringe fitting assembly.

Carefully wipe the exterior of the probe with alcohol or alcohol swabs or wipes (methanol can be substituted).

Position the probe upright on absorbent paper for about 10 minutes to allow residual fluid to drain.


Store the clean set of probes in your CARE kit or reinstall them on the instrument.


Running Daily Maintenance

As part of weekly maintenance, you should perform daily maintenance procedures. For information about how to do this, see Section 8.2: Daily Maintenance.

NOTE

Because installing clean aspirate probes is part of weekly maintenance, you do not need to clean the exterior of the aspirate probes, as described in the daily maintenance procedures.

Running System Check

As part of weekly maintenance, you should run the System Check routine. For information about how to do this, see Section 8.4: System Check.

1

2

3

4

5

6

7

8

9

10


Access 2 Operator’s Guide 8.4: System Check

8.4System Check

You perform the System Check routine as part of weekly maintenance to verify system performance. During weekly maintenance, the three System Checks (washed, unwashed, and substrate) are run together. You can also run the System Check routine more often, or perform individual checks.

For information on running individual system checks, see Section 5.11: Individual System Checks in the Reference Manual.

For troubleshooting information, see Appendix A: Troubleshooting in the Reference

Manual.


8.4: System Check Access 2 Operator’s Guide

System Checks ScreenThe System Checks screen displays an overview of the results from the System Check routine. The System Check routine generates six values that are represented by data points on the corresponding charts on the screen.

Use this screen to:

• View the results of up to 50 System Checks

• Display the System Check Data screen

To get to this screen from the Main Menu, select Maintenance Review F6 to display the Maintenance Review screen, then select System Checks F2.

0782C.bmp

Figure 8-26 System Checks Screen

Point CursorOut-of-Limit Data PointsDate Run



Out-of-Limit Data Points

(Icons) Red triangles identify results that are above or below the expected range.

Red diamonds identify results that are within the expected range, but the %CV is out of range.

Date Run (Scrolling Region) The x-axis at the bottom of the screen shows the date that the System Check routine was run. The system displays a maximum of 25 dates, and only displays the dates when a System Check was run. If more than one System Check was run on the same date, the date is repeated on the x-axis.

Point Cursor (Cursor) A blue vertical line indicates the System Check that is currently selected. The point cursor can be moved left or right by selecting the left and right arrow buttons, or by touching a data point.

Washed RLU (Chart) Displays the mean RLUs of the washed check within the range of expected results, from 5,000 to 20,000 RLUs.• Red triangles identify results that are above or below the range.

• Red diamonds identify results that are within the range, but the %CV is out of range.

Substrate RLU (Chart) Displays the mean RLUs of the substrate check within the range of expected results, from 5,000 to 9,000 RLUs. • Red triangles identify results that are above or below the range.


Unwashed RLU (Chart) Displays the mean RLUs of the unwashed check within the range of expected results (guideline only), from 4 to 10 million RLUs. • Red triangles identify results that are above or below the range.


Wash Efficiency PPM

(Chart) Displays the results of the wash efficiency calculation within the range of expected results, from -1.0 to + 1.0 ppm (parts per million). Red triangles identify results that are above or below the range.

Substrate Ratio (Chart) Displays the results of the substrate ratio calculation within the range of expected results, from 0 to 1.40.

Red triangles identify results that are above or below the range.

Substrate : Washed Ratio

(Chart) Displays the substrate to washed ratio calculation within the range of expected results (guideline only), from 0 to 1.25. Red triangles identify results that are above or below the range.

System Check Data F2

(Button) Select to display the System Check Data screen for the selected System Check (see Figure 8-28). You can use the screen to view the detail of the System Checks and to print the System Check Report.

Table 8-27 System Checks Screen Descriptions



System Check Data ScreenUse the System Check Data screen to:

• View the detail of the System Check results plotted on the System Checks screen

• Print the System Check Report

To get to this screen from the Main Menu, select Maintenance Review F6 to display the Maintenance Review screen, then

Select System Checks F2 to display the System Checks screen, then

Select a System Check on the System Checks screen, then

Select System Check Data F2.

0783D.bmp

Figure 8-28 System Check Data Screen

Completion (Field) Displays the completion date and time of the System Check.

Table 8-29 System Check Data Screen Descriptions



Wash Efficiency (Field) Displays the results of the wash efficiency calculation in parts per million. Out-of-range results are displayed in red.

Substrate Ratio (Field) Displays the results of the substrate ratio calculation. Out-of-range results are displayed in red.

Substrate : Washed Ratio

(Field) Displays the results of the substrate to washed ratio calculation. Out-of-range results (guideline only) are displayed in red.

Washed (Field) Displays the mean RLUs, SD, and %CV of the washed check. Out-of-range results are displayed in red.

All three results (mean RLUs, SD, and %CV) will display in red if the system encounters a fatal flag, such as QNS, while running a replicate.

Clean (Field) Displays the mean RLUs, SD, and %CV of the clean check. The results of the clean check are used for troubleshooting purposes only. As a guideline, the clean check mean should be less than the washed and substrate check means.

Substrate (Field) Displays the mean RLUs, SD, and %CV of the substrate check. Out-of-range results are displayed in red.


Unwashed (Field) Displays the mean RLUs, SD, and %CV of the unwashed check. Out-of-range results (guideline only) are displayed in red.


Sample ID (Data Column) Displays the name of the System Check that was run on the sample (either washed, unwashed, clean, or substrate).

RLU (Data Column) Displays the RLUs for the selected sample.

Dark Count (Data Column) Displays the dark count for the selected sample.

Drift Corr (Data Column) Displays the drift correction factor for the selected sample.

Pipettor (Data Column) Displays the value N/A. This column is reserved for future use.

Flags (Data Column) Displays up to two result flags for the selected sample.

Previous Check F2 (Button) Select to display the data for the previous date that a System Check was performed.

Next Check F3 (Button) Select to display the data for the next date that a System Check was per-formed.

Print F7 (Button) Select to print the System Check Report for the selected System Check (see Figure 8-30).

Table 8-29 System Check Data Screen Descriptions (continued)



Viewing and Printing System Check Result Data

Use this procedure to view the detail for the System Check results, and to print the System Check Report for a selected System Check result.

Go to the Maintenance Review screen. To get to this screen from the Main Menu, select Maintenance Review F6.

Select System Checks F2.

The System Checks screen is displayed.

Select the System Check result you want to view the data for.

NOTE

If you do not select a specific System Check result, data for the most recent result will be displayed.

Select System Check Data F2.

The System Check Data screen is displayed.

(Optional) To view other System Check results for a date close to the displayed data, select Previous Check F2 or Next Check F3.

Select Print F7 to print the System Check Report.

1

2

3

4

5



0807D.bmp

Figure 8-30 System Check Report

Page 1 of 1Technologist______________________________ Printed 03/08/07 07:41AM

System Check ReportAccess 2 Immunoassay SystemS/N 501240


123 Lake StreetTownsville, ST 33333101-555-2323 ext. 109 Jane Smith

Completion: 030807 07:40 AM Value Status LimitsWash Efficiency: 0.20 Pass -1.00-1.00*Substrate : Washed Ratio 0.80 Pass 0.00-1.25

*=Guideline only Substrate Ratio 1.11 Pass 0.00-1.40

System Check Mean Status Limits SD %CV Status Limits Washed 8613.16 Pass 5000-20000 268.13 3.11 Pass 0.00-12.00Clean 6910.75 140.01 2.03Substrate 6873.57 Pass 5000-9000 89.05 1.30 Pass 0.00-5.00*Unwashed 5755939.00 Pass 4000000-10000000 57194.13 0.99 Pass 0.00-2.00

Sample ID RLU Dark Count Drift Corr Pipettor FlagsWashed 9014 2.9 1.0 N/AWashed 8765 2.9 1.0 N/AWashed 8761 2.9 1.0 N/AWashed 8847 2.9 1.0 N/AWashed 8715 2.9 1.0 N/AWashed 8500 2.9 1.0 N/AWashed 8239 2.9 1.0 N/AWashed 8700 2.9 1.0 N/AWashed 8209 2.9 1.0 N/AWashed 8383 2.9 1.0 N/AClean 6964 2.9 1.0 N/AClean 6929 2.9 1.0 N/AClean 7108 2.9 1.0 N/AClean 6780 2.9 1.0 N/AClean 6772 2.9 1.0 N/ASubstrate 7241 2.9 1.0 N/ASubstrate 7081 2.9 1.0 N/ASubstrate 7621 2.9 1.0 N/ASubstrate 7084 2.9 1.0 N/ASubstrate 6837 2.9 1.0 N/ASubstrate 7005 2.9 1.0 N/ASubstrate 6791 2.9 1.0 N/ASubstrate 6799 2.9 1.0 N/ASubstrate 6847 2.9 1.0 N/ASubstrate 6963 2.9 1.0 N/AUnwashed 5765840 2.9 1.0 N/AUnwashed 5839490 2.9 1.0 N/AUnwashed 5763130 2.9 1.0 N/AUnwashed 5701660 2.9 1.0 N/AUnwashed 5709680 2.9 1.0 N/AUnwashed 5721760 2.9 1.0 N/AUnwashed 5708910 2.9 1.0 N/AUnwashed 5870080 2.9 1.1 N/AUnwashed 5751040 2.9 1.1 N/AUnwashed 5727800 2.9 1.1 N/A



0601B.wmf

Figure 8-31 Running the System Check Routine Flowchart


Load RackF1

System performssystem checks(40 minutes)

Unload rack

Enter valuesand initial

Maintenance Log, asapplicable

Resultsacceptable?

Yes

Compare results withexpected values

NoRepeat the

System Check

Load rack

Run

Place 2.0 mL samplecups in rack positions

7, 8, 9, and 10

Pipette 2.0 mLundiluted SystemCheck Solution

into cup 7

Pipette at least 1.0 mL wash buffer into cup 8

Leave cup 9 empty

Pipette 1.0 mL 1/501 System CheckSolution into cup 10

OKF1

Request Maintenance

Sample Manager

Type Rack ID

Main Menu

Sample ManagerF1

Maintenance RequestsF4

Select System Check(and Daily Clean

System, if runningweekly maintenance)

Troubleshoot SystemCheck results, orcontact Technical

Support

Resultsacceptable?Yes

No



System Check Required Materials

You need to gather the following materials to perform the System Check routine. This is the complete list of materials for the procedure. For a list of part numbers and for ordering information, see the instrument Instructions for Use.

WARNINGSystem Check Solution and wash buffer contain ProClin 300 preservative, which may cause sensitization by skin contact. After contact with skin, wash immediately with soap and water. Wear suitable gloves.


• 2.0 mL sample cups (four cups)

NOTE


• System Check Solution

• Wash buffer


Running the System Check Routine

Use this procedure to run a System Check routine. After you prepare and load the rack, the System Check routine takes approximately 40 minutes to complete.


NOTES

• If a fatal flag is applied to a system check result, the system will not use the results in the calculation of the mean, SD, or %CV. For more information, see Section A.2: System Check Troubleshooting in the Reference Manual.

• You can request and load maintenance routines while the system is processing patient samples. The maintenance routines run after the system completes the on-board patient samples.


1







NOTE


Select the System Check box and select All from the list.

NOTE

If you are running weekly maintenance, select the Daily Clean System option to run the Daily Clean System and System Check routines at the same time. Also, follow the Running the Daily Clean System Routine to load the sample cups.

Select OK F1.

The Maintenance Requests screen is displayed.

Prepare a 1/501 dilution of System Check Solution by mixing 20 μL System Check Solution with 10.0 mL of wash buffer.

Place the empty 2.0 mL sample cups in sample positions 7-10 of a rack.

Pipette 2.0 mL of undiluted System Check Solution into the sample cup in position 7. The sample cup should be full, but the solution level should not be higher than the top of the cup.

Pipette at least 1.0 mL of wash buffer into the sample cup in position 8.

Leave the sample cup in position 9 empty.

Pipette 1.0 mL of the 1/501 diluted System Check Solution into the sample cup in position 10.

Select Load Rack X F1. (The X represents the number of the rack that you entered into the Rack ID field.)


2

3

4

5

6

7

8

9

10

11

12



The system displays the Done window and presents a rack position.

NOTE



For more information on how to load a rack, see Section 3.1: Sample Management in this manual.

The routine, sample type, completion time, and status are displayed on the Maintenance Requests screen.




Select Run.

The system displays the testing results as the samples are processed. When processing is complete, the system runs the Utility Assay.

When the System Check is complete, unload the rack and select Done F1.


Compare the obtained results with the expected results. The results are listed in the report and Table 8-32.

• If the results are within the expected limits, and you are running weekly maintenance, proceed to step 17.

• If the results are outside the expected limits, repeat the System Check routine. If out-of-range results persist, see Appendix A: Troubleshooting in the Reference Manual or contact Technical Support.

Record the results of the System Check routine in the appropriate section of the Maintenance Log.

13

14

15

16

17



System Check Expected Results

The following results from the System Check routine should display on the System Checks and System Check Data screens. For troubleshooting information, see Appendix A: Troubleshooting in the Reference Manual.

System Check Expected Results

Washed Check 5,000 to 20,000 RLU mean

%CV ≤ 12.00

Clean Check No expected range

Substrate Check 5,000 to 9,000 RLU mean

%CV ≤ 5.00

Unwashed Check*

* Not a system specification. It should be used for reference purposes only. 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 routine.

4 to 10 million RLU mean*

%CV ≤ 2.00

Wash Efficiency PPM -1.00 to 1.00 PPM

Substrate Ratio 0 to 1.40

Substrate : Washed Ratio**

** Not a system specification. It should be used for reference purposes only.

0 to 1.25**

Table 8-32 System Check Routine Expected Results


Access 2 Operator’s Guide 8.5: Special Clean

8.5Special Clean

The Special Clean routine prevents buildup of debris in the primary and aspirate probes. You perform the Special Clean routine when additional cleaning is requested by Technical Support or required for troubleshooting.

NOTE

If you run the Vitamin B12 assay on your Access 2 system, perform the Special Clean routine at the end of each day or whenever the instrument will not process samples for 8 hours or more.

For an overview of how to perform the Special Clean routine, see Figure 8-33.


8.5: Special Clean Access 2 Operator’s Guide

0810C.wmf

Figure 8-33 Special Clean Routine Flowchart

Sample Manager

Enter the Maintenance Rack Number in the Rack ID field

Main Menu

Sample ManagerF1

Maintenance RequestF4

Load rack

The system cleans probe interiors(30 minutes)

Unload rack

Wait until the status bar indicates the cleaning

is complete


Load RackF1

Request Maintenance

Select Special Clean

Run

OKF1

Place 2.0 mL sample cups in rack positions

1, 2, 3, 4, 5, and 6

Pipette 2.0 mLContrad 70 into cup 1

Pipette 2.0 mL1/5 Citranox/deionized

water dilution into cup 2

Pipette 2.0 mL deionized water or

wash buffer into cup 3

Pipette 2.0 mL 70% ethanol* into cups

4, 5, and 6 * Alternatively, a 70% methanol solution may be used



Special Clean Routine Required Materials

Gather the following materials to perform the Special Clean routine. For a list of part numbers and for ordering information, see the instrument Instructions for Use.




• Citranox cleaning solution is acidic and may cause eye or skin irritation. See the manufacturer’s label for details.


• Ethanol and methanol are extremely flammable. Do not use near heat or flame. Do not ingest. Avoid contact with eyes, skin, and clothing. Use with adequate ventilation.


• 2.0 mL sample cups (six cups)

NOTE


• Contrad 70cleaning solution

• Citranox cleaning solution

• Deionized water or wash buffer

• 70% ethanol solution (7/10 dilution of 95% ethanol)—mix 7 parts ethanol and 3 parts wash buffer (alternatively, a 70% methanol solution may be used—mix 7 parts methanol and 3 parts wash buffer)

Running the Special Clean Routine

Use this procedure to run the Special Clean routine. After you prepare and load the rack, the Special Clean routine takes approximately 35 minutes to complete.


8.5: Special Clean Access 2 Operator’s Guide


NOTE

You can request and load maintenance routines while the system is processing patient samples. The maintenance routines run after the system completes the on-board patient samples.






NOTE


Select the Special Clean option.

Select OK F1.

Place empty 2.0 mL sample cups in sample positions 1, 2, 3, 4, 5, and 6 of the rack.

Pipette 2.0 mL of Contrad 70 cleaning solution into the sample cup in position 1.

Pipette 2.0 mL of a 1/5 dilution of Citranox cleaning solution (mix 1 part Citranox cleaning solution and 4 parts deionized water) into the sample cup in position 2.

Pipette 2.0 mL of deionized water into the sample cup in position 3.

WARNINGEthanol and methanol are extremely flammable. Do not fill sample tubes on the instrument or in the rack position in the sample carousel. Remove sample tubes from the instrument immediately after completing the Special Clean routine.

1

2

3

4

5

6

7

8

9



Pipette 2.0 mL of 70% ethanol* into each of the cups in sample positions 4, 5, and 6.

Select Load Rack X F1 on the Maintenance Requests screen. (The X represents the number of the rack that you entered into the Rack ID field.)


The system displays the Done window and presents a rack position.

NOTE



For more information on how to load a rack, see Section 3.1: Sample Management in this manual.

The Routine, Sample Type, Completion time, and Status are displayed on the Maintenance Requests screen.




Select Run.

When the Special Clean is complete, unload the rack and select Done F1.


* Alternatively, a 70% methanol solution may be used—mix 7 parts methanol and 3 parts wash buffer

Sample Position

1 2 3 4, 5, 6

Add 2.0 mL Contrad 70 1/5 Citranox Deionized Water

70% Ethanol*

10

11

12

13

14


8.6: Maintenance Log Access 2 Operator’s Guide

8.6Maintenance Log

You can use the Maintenance Log to verify that you perform all routine maintenance procedures. Make photocopies of the log for use with each Access 2 system.

A paper copy of the log is provided in the instrument Instructions for Use. Retain completed Maintenance Logs for reference.


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P/N B14251D 9/14

Access 2 Operator’s Guide A: Racks and Sample Containers

ARacks and Sample Containers

A.1 Racks............................................................................................................... A-2

Attaching Rack Bar Code Labels..................................................................... A-4

Cleaning Racks ................................................................................................ A-4

A.2 Sample Containers ....................................................................................... A-5

Calculating Sufficient Sample Volume............................................................ A-6

Attaching Sample Bar Code Labels ................................................................. A-6

Using Insert Cups in Bar Coded Sample Containers ....................................... A-7

Access 2 System Sample Containers ............................................................... A-8

2014 Beckman Coulter, Inc. A-1P/N B14251D 9/14

A.1: Racks Access 2 Operator’s Guide

A.1Racks

You load sample containers onto the Access 2 instrument in racks. Each rack holds up to 10 samples in the rack sample positions. The instrument holds up to six racks.

To accommodate sample containers of different sizes, the instrument uses three types of racks:

• 13 mm (for 12 mm and 13 mm sample tubes)

• 16 mm elevated (for 16 x 75 mm sample tubes)

• 16 mm (for 16 x 100 mm sample tubes)

Racks are identified by a bar code label. You affix the label to the rack according to the type of rack and the type of sample container you plan to use in the rack. Rack bar code labels 100 to 1899 include an icon to identify the type of sample container in the rack. Bar code labels 1 to 99 do not include an icon because you can use them for several different types of sample containers.

When the instrument scans the rack bar code label, it identifies the type of sample containers in the rack and determines the appropriate pipetting depth for aspirating sample. You must be sure that the sample volume is sufficient for pipetting. For example, a 12 x 75 mm tube has a corresponding dead volume of 500 µL and is placed in a rack with an ID between 1300 and 1399. Table A-1 summarizes which rack and rack ID you must use for the various sample containers.

CAUTION

Only load sample containers on a rack with the appropriate ID.

For information about sample containers for the Access 2 system with corresponding dead volumes and ranges for rack IDs, see Table A-5 in Section A.2: Sample Containers.

A-2 2014 Beckman Coulter, Inc.P/N B14251D 9/14

Access 2 Operator’s Guide A.1: Racks

Sample Container Rack Rack IDs

Access 2.0 mL/13 mm Sample Cup 13 mm1 - 99 or400 - 499

Access 2.0 mL/16 mm Insert Cup in 16 x 100 mm Tube 16 x 100 mm 200 - 299

Access 3.0 mL Sample Container

13 mm or

16 x 100 mm 500 - 599

Access 1.0 mL/13 mm Insert Cup in 13 x 100 mm Tube 13 mm 600 - 699

Access 1.0 mL/13 mm Insert Cup in 13 x 75 mm Tube 13 mm 700 - 799

16 x 75 mm Elevated Tube16 x 75 mm

ELEV 1000 - 1099

12 x 75 mm Tube, with or without separator gel or

13 x 75 mm Tube, with or without separator gel

Notes:

• 12 x 75 mm tubes may also be used with Rack IDs 1 - 99.

• 13 x 75 mm tubes may also be used with Rack IDs 1 - 99 or 800 - 899.

13 mm 1300 - 1399


Note: 13 x 100 mm tubes may also be used with Rack IDs 1 - 99 or 100 - 199.

13 mm 1400 - 1499


Note: 16 x 100 mm tubes may also be used with Rack IDs 900 - 999.

16 x 100 mm 1500 - 1599

Auto Aliquot Tube, 13 x 100 mm False Bottom 13 mm 1600 - 1699

Access 2 Pediatric Insert Cup in Pediatric Tube Adapter for 13 mm Rack 13 mm 1800 - 1899

90 x 13 mm 4.9 mL Sarstedt S-Monovette* Tube

* Monovette is a trademark of Sarstedt A.G. & Co.

13 mm 2100 - 2199

75 x 15 mm 5.5 mL Sarstedt S-Monovette Tube16 x 75 mm

ELEV 2200 - 2299

92 x 15 mm 7.5 mL Sarstedt S-Monovette Tube 16 x 100 mm 2300 - 2399

92 x 16 mm 9 mL Sarstedt S-Monovette Tube 16 x 100 mm 2400 - 2499

Beckman Coulter 0.5 mL Cup 13 mm 2500 - 2599

Table A-1 Sample Containers with Corresponding Rack and Rack IDs


A.1: Racks Access 2 Operator’s Guide

Attaching Rack Bar Code Labels

To be sure that the internal bar code reader can accurately read the rack bar code label, use this procedure to place the label on a rack.

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

0126C.epsR

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

With the bar code nearest the handle of the rack and the corresponding number underneath it (see Figure A-2), align the bar code label with the indentation and attach the label securely to the rack. To be sure the rack bar code is scanned correctly, there should be only a 0-1 mm gap at the bottom of the label.

Cleaning Racks

Clean racks in a dishwasher or autoclave, or use a brush and a mild detergent.

1 0-1 mm

2 Handle

3 Spine

Figure A-2 Rack Bar Code Label Placement

1

05

05

05

1

2

3

2

3


Access 2 Operator’s Guide A.2: Sample Containers

A.2Sample Containers

You place sample containers into the 10 sample positions in the racks. The Access 2 system identifies the types of sample containers by reading the rack bar code label. In addition, some laboratories affix sample bar code labels to the sample containers. The system identifies the sample by reading the bar code label on the sample container.

NOTES

• The 2.0 mL/13 mm sample cups in racks 1-99 or 400-499 must be used for maintenance. You do not affix bar code labels to maintenance sample cups. The system recognizes the sample cups by the rack ID, by the way you request tests in the system, and by the way you load the racks onto the instrument (see the Requesting Maintenance Routines procedure in Section 8.1: Routine Maintenance).

• You can intermix the allowable types of sample containers that are used in racks 1-99 for patient samples and quality controls. For calibrators, each sample in a calibrator set must be in the same type of sample container.

You place most sample containers directly in the rack. If you use insert cups, however, place them into sample tubes or rack inserts before adding them to the rack.

WARNINGS• Use only the recommended sample containers on the Access 2 instrument.

The system software contains specific parameters for each of the recommended sample containers. Other containers can damage the system and compromise the integrity of the test results.


For information about sample containers for the Access 2 system with corresponding dead volumes and ranges for rack IDs, see Table A-5 in this section.


A.2: Sample Containers Access 2 Operator’s Guide

Calculating Sufficient Sample Volume

To be sure the sample volume is sufficient for the tests to be run, calculate the total volume of sample needed for the sample container by using this equation:

0616A.wmf

NOTES

• To find the sample volume required per replicate, see the reagent instructions for use.

• Dead volume is the amount of sample in the bottom of a sample container that is required to be sure that enough sample is available for the instrument to complete an assay.

WARNINGIf you use tubes with separator gel, be sure that the tube contains sufficient sample volume. Insufficient sample volume may cause the instrument to attempt to aspirate the separator gel, which can damage the instrument and compromise the integrity of the test results.

For information about sample containers for the Access 2 system with corresponding dead volumes and ranges for rack IDs, see Table A-5 in this section.

Attaching Sample Bar Code Labels

To be sure the internal bar code reader can correctly read the sample bar code label, use this procedure to place a label on a sample container.


NOTE

The internal bar code reader automatically discriminates between symbologies, so samples with bar code labels using different symbologies can be included on the same rack. You may need to enable parameters for the bar code symbologies you use (see Section 4.3: Bar Code Reader Setup in the Reference Manual).

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 (see Figure A-3). Be sure that it is securely fastened.

Total samplevolume required

Sample volumerequired per

replicate

Number ofreplicates

Dead volumex + =

1



When you add the sample container to the rack, be sure the sample bar code label is centered in the opening slot of its rack position for accurate scanning.

0124D.eps

Using Insert Cups in Bar Coded Sample Containers

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

Use this procedure to add an insert cup to a bar-coded sample tube.

WARNINGCarefully pipette small sample volumes into the insert cup to prevent air bubbles from forming at the meniscus. Air bubbles can affect level sensing by the instrument and compromise the integrity of the test results.

Transfer the required sample volume from the sample tube with a bar code label into the insert cup.

Place the cup back into the original sample tube, which has the bar code label attached (see Figure A-4).

Add the tube to a rack appropriate for the insert cup and the sample tube. Be sure the sample bar code is centered in the opening slot of its rack position for accurate scanning.

1 Minimum distance = 0.25 inch or 0.6 cm

2 Minimum distance = 0.25 inch or 0.6 cm

Figure A-3 Sample Bar Code Label Placement

2

AB

C1

23

45

67

89

AB

C1

23

45

67

89

1

2

1

2

3



0127D.eps

Access 2 System Sample Containers

The following table lists all of the sample containers you can currently use on the Access 2 instrument, the corresponding rack ID range and the dead volume for each container.

WARNINGS• You must have a sufficient volume of sample to process the tests you

requested. To be sure you have enough sample, calculate the total volume needed for the sample container using the Calculating Sufficient Sample Volume procedure in this section. If you do not follow the provided procedure, sample processing problems may occur without warning.


1 Insert Cup

2 Sample Tube

3 Rack ID

Figure A-4 Loading Insert Cups

AB

C1

23

45

67

89

�

XXX

1

2

3



Sample Container Information Bar Code Label Icon


13 x 75 mm Tube with or without separator gel

• Border: Lime green

• Rack IDs: 1300 - 1399

• Dead Volume: 500 µL

NOTE: 13 x 75 mm tubes may also be used with Rack IDs 1 - 99 or 800 - 899, at a Dead Volume of 3.4 mL.


• Border: Forest green

• Rack IDs: 1400 - 1499

• Dead Volume: 3.0 mL

NOTE: 13 x 100 mm tubes may also be used with Rack IDs 1 - 99 or 100 - 199, at a Dead Volume of 4.9 mL.


• Border: Lime green

• Rack IDs: 1300 - 1399

• Dead Volume: 500 μL

NOTE: 12 x 75 mm tubes may also be used with Rack IDs 1 - 99, at a Dead Volume of 3.4 mL.


• Border: Midnight blue

• Rack IDs: 1500 - 1599


NOTE: 16 x 100 mm tubes may also be used with Rack IDs 900 - 999, at a Dead Volume of 7.6 mL.

16 x 75 mm Elevated Tube

• Border: Purple

• Rack IDs: 1000 - 1099


Access 3.0 mL Sample Container

• Border: Red

• Rack IDs: 500 - 599


Access 2.0 mL/13 mm Sample Cup

• Border: Dark green

• Rack IDs: 1 - 99 or 400 - 499 (only 400 - 499 have the icon)


Access 1.0 mL/13 mm Insert Cup in 13 x 100 mm Tube

• Border: Blue

• Rack IDs: 600 - 699


Table A-5 Sample Containers with Rack and Volume Requirements

1

3x75

GE

L

1

3x75

13x1

00

1

3x10

0 G

EL

12x7

5

16

x1

00

1

6x10

0 G

EL

16x7

5

2.0 mL

13x1

00




• Border: Light green

• Rack IDs: 700 - 799


Beckman Coulter 0.5 mL Cup

• Border: Light pink

• Rack IDs: 2500 - 2599


Auto Aliquot Tube, 13 x 100 mm false bottom

• Border: Purple

• Rack IDs: 1600 - 1699



• Border: Orange

• Rack IDs: 200 - 299


Access 2 Pediatric Insert Cup in Pediatric Tube Adapter for 13 mm rack

• Border: Pink

• Rack IDs: 1800 - 1899


Sarstedt S-Monovette Tube,90 x 13 mm 4.9 mL

• Border: Dark brown

• Rack IDs: 2100 - 2199

• Dead Volume: 3 mL


• Border: Red-brown

• Rack IDs: 2200 - 2299



• Border: Light brown

• Rack IDs: 2300 - 2399


Sarstedt S-Monovette Tube,92 x 16 mm 9 mL

• Border: Gray-brown

• Rack IDs: 2400 - 2499




Table A-5 Sample Containers with Rack and Volume Requirements (continued)

13x7

5

0.5 mL

Aut

oaliq

uot

16 m

m

Ped

iatr

ic

4.9 mL

Sa

rste

dt

5.5 mL

Sa

rste

dt

7.5 mL

Sa

rste

dt

9.0 mL

Sa

rste

dt


2014 Beckman Coulter, P/N B14251D 9/14

Access 2 Operator’s Guide Index

Index

AAccess 2 System Documentation Preface-3

Active Calibrations

Defined 6-9

Switching with Previous 6-16

Analytical Module 1-4

APFs, Software Overview 1-13

Arrow Button Preface-10

Aspirate Probes

Cleaning 8-38

Cleaning with Contrad 70 Solution 8-42

Cleaning with Distilled Water 8-44

Disconnecting Tubing 8-36

Installing Clean 8-37

Precleaning 8-39

Removing 8-35

Replacing 8-35

Replacing and Cleaning (Flowchart) 8-34

Assay Protocol Files (APFs) 1-13

Assays

Calibrations 6-1, 6-2

Qualitative Cutoffs 6-2

Quality Controls 7-3

Quantitative Curves 6-2

Reviewing Calibration Data 6-8

Semi-Quantitative Curves 6-2

Utility Assay 8-6

Attention Safety Symbol 1-6

Auto Sample ID

Using 3-35

Using (Flowchart) 3-34

BB12

See Vitamin B12 Assay

Back Tab 1-24

Backups

Daily Maintenance 8-18

Bar Code Labels

Attaching rack A-4

Attaching sample A-6

Rack A-2

Rack placement A-4

Sample A-6, A-7

Sample Placement A-7

Bar Code Readers

Entering Tests While Disabled 3-31

Handheld Scanning Procedure 2-5

Internal 3-7

Scanning Containers in Racks 3-10

Scanning for LIS Requests 3-28

Wand Scanning Procedure 2-4

Working with On-Board Samples 3-50

Bar Codes

Manually Scanning 2-4

Scanning Reagent Pack 2-36

Batch Request

Using 3-37

Using (Flowchart) 3-36

Batteries

EU Directive 1-10

Safe Disposal 1-10

Beckman Coulter

0.5 mL cup A-3

Contact Information Preface-16

Inc. Index-1

Index-2

Index Access 2 Operator’s Guide

Biohazard Safety Symbols 1-7

Buffer, Wash

See Wash Buffer

Buttons

Cancel F8 1-28

Common Descriptions 1-28

Function 1-24

Help F12 1-28

Highlighted in the Text Preface-7

Main Menu Function 1-14

OK F1 1-28

System Command 1-20

System Status Preface-7, 1-21, 2-3, 2-4

Window View Preface-10

CCalculations, Quality Control 7-3

Deleting Data Points 7-18

Omitting Data 7-15

Omitting Data Points 7-17

Calculations, Sample Volume A-6

Calibration Conditions 4-11

Calibration Controls

See Calibrators

Calibration Test Requests

Entering 3-40

Entering (Flowchart) 3-39

Calibrations

Active 6-9

Adding a Comment 6-16

Applying a Filter 6-6

Assay 6-1

Assay Overview 6-2

Calibrator Setup 6-22

Data Report (Curve) 6-21

Data Report (Cutoff) 6-20

Data Review 6-8

Data Screen (Curve) 6-11

Data Screen (Cutoff) 6-10

Deleting 6-7

Entering Test Requests 3-40

Failure Codes 6-14

Flowchart 6-3

Last Run 6-9

Overriding Expired 4-16

Previous Active 6-9

Printing a Report 6-18

Report 6-19

Reports 6-17

Request Window 3-40

Requests 3-25

Sample Management 3-3

Screen 6-4

Stored Data 6-9

Supply and Conditions 4-11

Supply Status 2-3

Switching Active with Previous 6-16

Test Menu 3-41

Test Requests 3-38

Verifying Conditions 4-16

Verifying Expirations 4-11

Viewing Curves or Cutoffs 6-15

Calibrators

Add Window 6-26

Adding 6-26

Adding (Flowchart) 6-25

Deleting 6-28

Editing 6-27

Setting Up 6-22

Setup Screen 6-23

Canadian Standards Association Label 1-9

Carousel Module 1-4

Cautions

Indicators of Instrument Damage

Preface-16

Instrument 1-8

Radio Frequency 1-12

CE Mark Label 1-9

Change Substrate Window 2-19

Chapter Organization Preface-6

CISPR 11 Compliance 1-11, 1-12

Citranox Cleaner


Safe Handling 8-16

Special Clean Routine 8-59

Cleaning

Aspirate Probes 8-38

Instrument Exterior 8-30

Primary Probe 8-32

Probe Exteriors 8-20




Racks A-4


Comments

Adding to Calibration 6-16

Entering for Sample 3-16

Entering QC 3-47, 7-17

Notepad Button 3-16

Pen Button 3-16

Configuring

Calibrators 6-22

Test Results Screen 5-28

Consumables 2-3

Contamination

Substrate 2-20

Wash Buffer 2-11

Continuous Access 1-3

Sample Processing 4-3


Contrad Cleaning Solution


Safe Handling 8-16


Weekly Maintenance 8-29, 8-38

Controls, Quality

See Quality Controls

Copying Data


Test Results 5-36

C-Tick Mark 1-9

Cups

See Sample Containers

Curves

Quantitative 6-2

Viewing Assay Calibrations 6-15

Cutoffs

Qualitative 6-2

Viewing Assay Calibrations 6-15

DDaily Clean System


Definition 8-9

Flowchart 8-24

Maintenance Routine 8-9

Running 8-24

Daily Maintenance

Checking System Status 8-18

Checking System Status (Flowchart) 8-17

Cleaning Probes 8-20

Cleaning the Wash Carousel Probe Exteriors (Flowchart) 8-20

Daily Clean System 8-24

Daily Clean System Routine (Flowchart) 8-24

During Weekly Maintenance 8-44

Flowchart 8-15

Inspecting Fluidics 8-19

Inspecting the Fluidic Module (Flowchart) 8-19

Overview 8-14

Priming Substrate 8-23

Priming the Substrate (Flowchart) 8-22

Required Materials 8-16

Data Management

Copying Test Results 5-36

Test Results 5-31

Data Points, Omitting QC 7-17

Dead Volume

By Sample Container A-8

Definition A-6

Decontaminate, Liquid Waste Bottle 2-15

Disks

Copying QC Data 7-19


Dispense Cap Assembly 2-12

Disposal

RoHS Standard 1-11

WEEE Directive 1-10

Documentation

LIS Vendor Preface-6

System Preface-3

Download

LIS and Work Pending 4-19

LIS Container Assignment 4-8

LIS Sample Processing 4-2

EElectrical Safety Symbol 1-6

Inc. Index-3

Index-4


Electronics Module 1-4

Electrostatic Discharge (ESD) Safety Symbol 1-8

Elevated Tube A-3

Emissions, Radio Frequency 1-11

Environmental

Also See Regulatory

RoHS Marks 1-11

Errors, Resolving Sample 3-14

Evaporation, Sample 3-9

Example Button Preface-10

Exclamation Point Label 1-6

Expiration Date

Calibration 6-8

Quality Control 7-31

Reagent Lot 2-31, 2-40

Reagent Pack 2-40

Substrate Open Bottle 2-17

Expired

Overriding Supply Conditions 4-16

Reagent Lots 4-11

Reagent Packs 4-11

Substrate 4-11

FFailure Codes, Calibration 6-14

FCC Compliance 1-11

Fields

Available 1-25

Information 1-25

List 1-25

Names Highlighted in the Text Preface-7

Selecting and Entering 1-27

Unavailable 1-25

Filters

About Test Results 5-9

Applying a QC 7-7

Applying a Test Result 5-11

Applying a Test Result (Flowchart) 5-11

Calibration 6-6

Defining a Test Result 5-19

Defining a Test Result (Flowchart) 5-18

Deleting a Test Result 5-20

Editing a Test Result 5-15

Editing a Test Result (Flowchart) 5-14

Finding Test Results 5-22

QC Chart and Data 7-15


Reagent Inventory 2-46

Test Results, System-Defined 5-11

Work Pending 4-22

Find Feature in Help Preface-14

Flags

See Test Result Flags

Flash Drives

Copying QC Data 7-19


Flowchart Button Preface-10

Flowcharts

Adding a Calibrator 6-25

Applying a Test Result Filter 5-11

Calibration 6-3

Changing the Liquid Waste Bottle 2-14

Changing the RV Waste Bag 2-29

Changing the Substrate Bottle 2-18

Changing the Wash Buffer Bottle 2-11

Checking for Fluid in the Waste Filter Bottle 8-31

Checking System Status 8-17

Cleaning Primary Probe Exterior 8-32

Cleaning Probe Exteriors 8-20

Comparing QC Charts 7-24

Configuring the Test Results Screen 5-28

Copying Test Results to a Disk or USB Flash Drive 5-35

Daily Clean System 8-24


Defining a Test Result Filter 5-18

Deleting a Reagent Pack 2-48

Deleting a Test Result 5-40

Editing a Test Result Filter 5-14

Editing Test Requests for On-Board Samples 3-51

Entering Calibration Test Requests 3-39

Entering Patient Test Requests Manually

3-30

Entering Quality Control Test Requests

3-44

Finding a Test Result 5-22

Inspecting the Fluidic Module 8-19

Loading a Reagent Pack 2-32

Loading RVs 2-25





Printing Test Result Reports 5-44

Processing LIS Test Requests 3-27

Processing Samples 4-4


Replacing and Cleaning Aspirate Probes

8-34

Running System Checks 8-52


Sending Test Results to the LIS 5-32

Setting Up Quality Controls 7-32


Test Results 5-3

Unloading a Reagent Pack 2-37

Using Auto Sample ID 3-34

Using Batch Request 3-36

Viewing Sample Details (Test Results) 5-25

Weekly Maintenance 8-28


Fluidic Module 1-4

Inspecting 8-19

Inspecting (Flowchart) 8-19

Formulas

Required RVs for Utility Assay 8-7

Sample Volume A-6

Function Buttons 1-24

GGlossary

Help Link Button Preface-11

Help Window Button Bar Preface-12

HHelp

Cautions Preface-16

Exiting System Preface-11

Find Feature Preface-14

Glossary Preface-12

Index Preface-14

Notes Preface-16

Print Preface-12

System Preface-5

Topics Window Preface-13

Using the Help System Preface-8

Warnings Preface-16

Window Button Bar Preface-12

Window Menu Preface-13

Windows Preface-11

Help Buttons

Arrow Preface-10

Example Preface-10

Flowchart Preface-10

Links Preface-10

More Info Preface-11

Navigation Preface-10

Screen View Preface-10

See Also Preface-10

Show Me Preface-10

Highlighted Text (Green) Preface-15

Host Query 4-8

IID

See Rack IDs

See Sample IDs

IEC Compliance 1-11

Index in Help Preface-14

Infectious, Biohazard Symbol 1-7

Insert Cups

In Bar Coded Sample Containers A-7

Loading A-8

Inspecting

Fluidic Module 8-19

Liquid Waste Bottle 8-30

Primary Probe 8-32

Samples 3-9

Installation 1-5

No Other Applications 1-14

Instrument

Cautions Regarding Possible Damage

Preface-16

Cleaning the Exterior 8-30

Instructions for Use Preface-5

Overview 1-4

Software 1-13

Insufficient Sample Volume 3-6

Interlock Switch 1-5

Inc. Index-5

Index-6


LLabels

Attaching Rack Bar Code A-4

Attaching Sample Bar Code A-6

Rack Bar Code A-2

Rack Bar Code Placement A-4

Regulatory 1-9

Safety Symbols 1-6

Sample Bar Code A-6, A-7

Sample Bar Code Placement A-7

Laboratory Information System (LIS)

See LIS

Laser Safety Symbol 1-8

Last Run Calibrations, Defined 6-9

LED Safety 1-12


Compare Charts Screen 7-22

Comparing 7-25

Description 7-10

Quality Control Screen 7-5

Reviewing 7-9

Liquid Waste

Bottle 2-13, 2-16

Button 2-13, 4-13, 4-20

Changing the Bottle 2-15

Changing the Bottle (Flowchart) 2-14

Drain Kit 2-13

Inspecting Bottle for Wear 8-30

Supplies 2-3

Supplies Overview 2-13

Supply Status 2-3

Verifying Bottle Capacity 4-11

LIS

Container Assignment 4-8

LIS Vendor Information Document Preface-6

Processing Patient Test Requests 3-27

Resending Fail Status 5-32


Sending Test Results to 5-32

Sending Test Results to (Flowchart) 5-32

Software Feature 1-14

Status for Test Results 5-2, 5-6

Test Request 4-2

Work Pending 4-19

Work Pending Filter 4-22

Workpool 4-8

LIS Vendor Information Document Preface-6

LIS Workpool

Assignment Rules 4-8

Container Assignment 4-8

Work Pending Screen 4-21

Loading

Racks 3-11

Reagent Packs 2-33

RVs 2-25

Samples in Racks 3-9

Logs

Also See Worksheets

Maintenance 8-62

MMain Menu 1-14, 1-15

Tab 1-24

Workflow 1-17

Main Menu Function Buttons 1-14

Calibration Review 1-16

Configure 1-17

Diagnostics 1-17

Maintenance Review 1-16


Sample Manager 1-15

Supplies 1-16

Test Results 1-16

Main Pipettor Module 1-4

Maintenance

Daily 8-14

Fluidics Inspection 8-19

Log 8-62

Maintenance Requests Screen 8-11, 8-12


Requesting Maintenance Routines 8-8

Review Screen 8-5

Routine 8-3

Running System Checks 8-53


Special Clean 8-57


System Checks 8-45




Utility Assay, Enabling or Disabling 8-8

Viewing System Check Data 8-50

Weekly 8-27

Maintenance Log 8-62

Manuals

Chapter Organization Preface-6


Preface-5

Material Safety Data Sheet Preface-6

Online Preface-6

Reference Manual Preface-3

Required and Optional Steps Preface-8

Using this Manual Preface-6

Material Safety Data Sheet Manual Preface-6

Mean RLU

Substrate Check Expected Results 8-56

Unwashed Check Expected Results 8-56

Washed Check Expected Results 8-56

Menu Tab 1-24

Menus

Calibration Test 3-41

QC Test 3-46

Modes, System 1-19

Modules

Analytical 1-4

Carousel 1-4

Electronics 1-4

Fluidic 1-4

Main Pipettor 1-4

Peripheral 1-4

More Info Button Preface-11

Moving Parts Safety Symbol 1-7

NNavigation

Keyboard Equivalents 1-26

System 1-26

Test Requests Screen 3-26

Navigation Button Preface-10

Notepad Button 3-16

OOn-Board Samples

Adding 3-49

Deleting Test Requests for 3-54

Deleting Test Requests for (Flowchart) 3-53

Editing Test Requests for 3-52

Rearranging 3-49

Removing 3-49

Working with 3-48

Working with (Flowchart) 3-49

Online

Manuals Preface-6

Support, USA and Canada Preface-16

Optional Steps Preface-7

Overriding 4-16

PPacks

See Reagent Packs

Padlock

Reagent Pack In Use 2-7

Unloading Reagent 2-37

Password Protected

See Secured Operations

Password Setup 1-17

Patient Report 5-47

Patient Test Requests

Batch Request 3-37

Entering Manually 3-31

Entering Manually (Flowchart) 3-30

Overview 3-19

Processing LIS 3-27

Using Auto Sample ID 3-35

Pause Button

Description 1-20

Pausing Sample Processing 4-5

Using to Add Tests to On-Board Samples 3-56

Using to Delete Tests from On-Board Samples 3-58

Pen Button 3-16

Peripherals Module 1-4

PPM, Wash Efficiency 8-56

Previous Active Calibrations

Defined 6-9

Switching with Active 6-16

Inc. Index-7

Index-8


Primary Probe

Cleaning the Exterior 8-32

Cleaning the Exterior (Flowchart) 8-32

Inspecting 8-32


Printing

Also See Reports

Calibration Reports 6-18

Help Preface-12

QC Chart and Data Report 7-28

QC Reports 7-26

Reagent Inventory Report 2-49

Supplies Required Report 4-17

System Check Reports 8-50

Test Result Reports 5-44

Work Pending Report 4-24

Probes

Cleaning the Primary 8-32

Cleaning Wash Carousel 8-20

QQC

Also See Quality Controls

Chart and Data Screen 7-11

Collecting Data for Ranges 7-39

Comparing Charts 7-25

Comparing Charts (Flowchart) 7-24

Establishing Ranges 7-39

Filter Applying 7-7

Point Deleting 7-18

QC Chart Report 7-30

QC Data Report 7-29

QC Review Report 7-27

Reports 7-26

Saving Comparisons 7-25

Setup Screen 7-33

Temporary Ranges 7-41

Westgard QC Rules 7-9

QC Charts

Comparing 7-21, 7-25

Comparing (Flowchart) 7-24

Deleting Comparisons 7-8

Levey-Jennings 7-10

Printing Report 7-28

Reviewing 7-9

Saving Comparisons 7-25

QC Charts and Data

Filter 7-15

Viewing 7-15

QC Comparisons

Deleting 7-8

QC Charts 7-25

Saving 7-25

QC Rules

See Westgard QC Rules

Qualitative

Assay Calibrations 6-2

Cutoffs 6-2

Quality Control Test Requests

Entering 3-45

Entering (Flowchart) 3-44

Overview 3-43


Adding 7-34

Button 7-5

Calculations 7-3

Charts and Data, Viewing 7-15

Compare Charts Screen 7-21

Copying Data 7-19

Data 7-3

Data Out of Range 7-10

Deleting 7-37

Deleting Chart Comparisons 7-8

Editing 7-37

Entering Comments for QC Data 7-17

Entering Tests 3-45

Establishing Ranges 7-39

Filter 7-7

Flowchart 7-4

Omitting Data Points 7-17

Overview 7-3

Printing Reports 7-26

Ranges, Collecting Data for 7-39

Ranges, Temporary 7-41

Reports 7-26

Requests 3-25

Reviewing Data 7-9

Reviewing Levey-Jennings Charts 7-9


Screen 7-5

Setting Up 7-31




Setting Up (Flowchart) 7-32

Setting Up (Worksheet) 7-42

Test Requests 3-43

Westgard QC Rules 7-9

Worksheet 7-42, 7-43

Quantitative


Curves 6-2

Query, Host 4-8

Quick Reference Guide


Preface-5

RRack Bar Code Labels

Attaching A-4

Instrument Scanning A-2

Placement A-4

Rack IDs

Changing 3-15

Sample Container Ranges A-8

Sample Containers A-3

Unique for Workgroup 3-11

Rack Status

Aspiration 3-7

Completion Time 3-7

Field on Test Requests Screen 3-21

Monitoring 4-25

Rack Button 3-6

Sample Manager Descriptions 4-26

Unloading Racks 3-13

Racks

Cleaning A-4

Clearing 3-16

Loading 3-11, 3-12

Loading Restriction 4-3

Overview A-2

Placing Sample Containers in 3-9

Processing Status 4-25

Sample Containers A-3

Unloading 3-12

Radio Frequency

Cautions 1-12

Emissions 1-11

Interference 1-12

Random Access 1-3

Ranges

Collecting Data for QC 7-39

Establishing QC 7-39

Quality Control 7-39, 7-41

Temporary QC 7-41

Ratios

System Check Substrate 8-56

System Check Substrate : Washed 8-56

Reaction Vessels

See RVs

Reagent Carousel

Loading Reagent Packs 2-35

Misplaced Packs 2-39

Unloading Reagent Packs 2-38

Reagent Inventory

Applying a Filter to the Screen 2-45

Deleting Reagent Packs 2-48

Overview 2-40

Printing the Report 2-49

Report 2-50

Screen 2-42

Reagent Lot Number

Changing for Calibration 3-17

Changing For QC 3-17

Expired 4-11

Reagent Packs

Bar Code Scanning 2-36

Deleting (Flowchart) 2-48

Deleting from Inventory 2-48

Expired 4-11

Inventory 2-40

Load Window 2-34

Loading 2-33

Loading (Flowchart) 2-32

Loading into the Reagent Carousel 2-35

Mixing 2-34

Monitoring 2-31

Overview 2-31

Retrieving Misplaced 2-39

Supplies 2-3

Supplies Required Button 2-31

Supply Status 2-3

Unloading 2-37

Unloading (Flowchart) 2-37

Verifying Unexpired Supply 4-11

Inc. Index-9

Index-10


Recycling

RoHS Standard 1-11

WEEE Directive 1-10

Reference Manual Preface-3

Reflex Tests

Counted in Tests Requested 4-13

Rack Removal 4-25

Removing Aspirated Samples 3-50

Work Pending 4-19


Refrigeration

Maintaining Temperature 8-6

Storing Reagent 2-38

Regulatory

Australian Communications Authority

1-9

Battery Directive 1-10

Canadian Standards Association 1-9

CE Mark 1-9

CSA Symbol 1-9

C-Tick Mark 1-9

EU Directives 1-9, 1-10

Radio Frequency Emissions 1-11

RoHS marks 1-11

Symbols and Statements 1-9

WEEE mark 1-10

Reports

Calibration 6-17, 6-19

Calibration Data (Curve) 6-21

Calibration Data (Cutoff) 6-20

Continuous Sample 5-50

Laboratory Information 1-29, 1-30

List of 1-29

Patient 5-47

Printing a Calibration 6-18

Printing System Check 8-50

Printing Test Results 5-44

Printing the Reagent Inventory 2-49

QC Chart 7-26

QC Data 7-26

QC Review 7-26



Result 4-7

Result Report Types 5-42

Sample 5-48

Selected Test Results 5-49

Standard Information 1-29, 1-30

Supplies Required 4-17, 4-18

System Check 8-51

Test Results 5-42

Work Pending 4-24

Requests

Entering Calibration Test 3-40

Entering Calibration Test (Flowchart) 3-39

Entering Quality Control Test 3-45

Entering Quality Control Test (Flowchart) 3-44

Maintenance Routines 8-8

Patient Test 3-19

Processing LIS Patient Test 3-27

Processing LIS Test (Flowchart) 3-27

Using Batch (Flowchart) 3-36

Rerun Tests

Work Pending 4-19


Reservoir Receptacle 2-12

Result Flags

See Test Result Flags

Results, QC

See QC Charts and Data

Results, Test

See Test Results

RoHS Labels

Caution 1-11

Environmental 1-11

Routine Maintenance 8-1

Daily 8-14

Effect on Warranty 1-5

Overview 8-3

Utility Assay 8-6

Weekly 8-27

Rules for Assigning Tests to Containers 4-8,

4-9

Rules, Westgard QC

See Westgard QC Rules

Run Button

Description 1-20


RV Cartridge 2-25




RV Load Door 2-26

RV Waste Bag Button 2-28

RV Waste Bags

Button 2-28

Changing the 2-29

Changing the (Flowchart) 2-29

Overview 2-28

Supply Status 2-3

Verifying Remaining Capacity 4-11

RVs

Button 2-24

Changing the Waste Bag 2-29

Loading 2-25

Loading (Flowchart) 2-25

Loading Capacity 2-24

Supplies 2-3

Supply Overview 2-24

Supply Status 2-3

Verifying Supply 4-11

Waste Bag 2-28

SSafety

Attention Symbol 1-6

Biohazard Symbol 1-7

Electrical Symbol 1-6

Electrostatic Discharge (ESD) Symbol 1-8

Exclamation Point 1-6

Features 1-5

General Information 1-8

Interlock Switch 1-5

Laser Symbol 1-8

Moving Parts Symbol 1-7

Sharp Objects Symbol 1-7

Symbols 1-6

Warnings Preface-16

Sample Bar Code Labels

Attaching A-6

Placement A-7

Sample Containers

Access 2 System A-8

Assignment Rules, Multiple Instruments

4-9

Assignment Rules, One Instrument 4-8

Assignment Rules, Same Sample ID 4-9

Calculating Sample Volumes A-6

Elevated Tubes A-3

Insert Cups A-3

LIS Container Assignment 4-8

Maintenance A-5

Overview A-5

Pediatric Insert Cup A-3

Rack ID Table A-3

Remove Caps 3-10, A-5

Sample Cups A-3

Using Insert Cups A-7

Sample Errors

Resolving 3-14

Sample IDs

Attaching Bar Code Labels A-6

Auto 3-21

Auto Option 3-35

Bar Code Labels 3-10

Editing 3-52

Entering Manually 3-31

Errors 3-7

Field on Test Requests Screen 3-22

Multiple Instruments 4-2

Unique for Test Request 3-3

Using Auto (Flowchart) 3-34


Errors 3-7

Flowchart 3-4

Overview 3-3

Rack Status 4-25

Resolving Sample Errors 3-14

Sample Status 4-27

Sample Manager Screen 3-5


About 4-2

Flowchart 4-4

Monitoring Progress 4-25

Order Criteria 4-7

Pausing 4-5

Rack Status 4-25

Sample Status 4-27

Starting 4-5

Stopping 4-6

Test Status 4-27

Work Pending 4-19

Inc. Index-11

Index-12


Sample Progress, Monitoring 4-25

Sample Report

Continuous 5-50

Test Results 5-48

Sample Status

Monitoring 4-27

Test Request Descriptions 4-27

Sample Tube, Loading Insert Cups A-8

Sample Volumes

Calculating Sufficient A-6

Insufficient 3-6

Required A-2, A-6

Separator Gel A-6

Samples

Also See On-Board Samples

Adding Test Requests Using Pause Button 3-56

Adding to On-Board Rack 3-49

Calibration 3-25

Calibration Test Requests 3-38

Continuous Report 5-50

Deleting Test Requests for On-Board (Flowchart) 3-53

Deleting Test Requests Using Pause Button 3-58

Deleting Test Requests While On-Board 3-54

Editing Test Requests While On-Board

3-52

Editing Test Requests While On-Board (Flowchart) 3-51

Evaporation 3-9

Less than 1 mL 3-10

Loading 3-9

Management 3-3

Monitoring Status 4-27

On-Board (Working with) 3-48

Patient Test Requests 3-19

Pausing in Process 4-5

Placing in Racks 3-9

Processing 4-2

Processing Order 4-7


Quality Control Test Requests 3-43

Rearranging On-Board 3-49

Removing On-Board 3-49

Report 5-48

Resolving Errors 3-14

Starting to Process 4-5

Stopping in Process 4-6

Viewing Test Result Details 5-25

Scanning

Bar Code Procedure 2-4

Reagent Packs 2-36

Screen View Button Preface-10

Screens

Calibration 6-4

Calibration Data (Curve) 6-11

Calibration Data (Cutoff) 6-10

Calibrator Setup 6-23

Common Elements 1-19

Compare Charts (QC) 7-21

Maintenance Requests 8-11, 8-12

Maintenance Review 8-5

QC Chart and Data 7-11

QC Setup 7-33

Quality Control 7-5


Sample Manager 3-5

Supplies 2-6

Supplies Required 4-13

System Check Data 8-48

System Checks 8-46

Test Requests 3-20

Test Results 5-4

Work Pending 4-20

Scroll Bar 1-24

Searching the Help Preface-15

Secured Operations

Deleting a Quality Control 7-38

Deleting QC Point 7-18

Deleting Test Results 5-41

See Also Button Preface-10

Semi-Quantitative


Curves 6-2

Sensors

Liquid Waste Weight 2-13

Viewing Information 1-17

Wash Buffer Level 2-10

Setup

Calibrators 6-22

Quality Controls 7-31, 7-34, 7-37




Sharp Objects Safety Symbol 1-7

Show Me Button Preface-10

Sodium Azide

Safe Handling 1-8

Special Clean

Flowchart 8-58

Maintenance Routine 8-9

Overview 8-57



Running 8-59

Running Vitamin B12 8-10

Vitamin B12 Assay 8-14

STAT Access 1-3

Status

Buttons Preface-7

Calibration Failure Codes 6-14

Checking System 8-18

Monitoring Racks 4-25

Monitoring Sample Progress 4-25

Monitoring Samples 4-27

Monitoring Test 4-27

Status Line 1-26

Steps

Optional Preface-8

Required Preface-8

Stop Button

Description 1-20

Stopping Sample Processing 4-6

Substrate 2-19

Bottle 2-17, 2-19

Bottle in Use 2-17

Bottles 2-21, 2-22

Button 2-17

Change Window 2-19

Changing Bottle Restriction 4-3

Changing the Bottle 2-19


Contamination 2-20

Partial Bottles 2-19

Priming 8-23

Priming (Flowchart) 8-22

Supplies 2-3

Supply Overview 2-17

Supply Status 2-3

Verifying Unexpired Supply 4-11

Substrate Check, Expected Results 8-56

Supplies

Changing the RV Waste Bag 2-29

Changing the Substrate 2-19

Changing the Wash Buffer Bottle 2-11


Door 2-26

Liquid Waste Removal 2-13

List of Required 4-17

Loading Reagent Packs 2-33

Loading RVs 2-25

Overriding Conditions 4-16

Overview 2-3


Reagent Packs 2-31

RV Waste Bag 2-28

RVs Overview 2-24

Screen 2-6

Substrate Overview 2-17

Unloading Reagent Packs 2-37

Verifying Sufficient 4-11, 4-16

Supplies Required

Overriding 4-16


Report 4-18

Screen 4-13

Verifying 4-16

Supply Conditions 4-11

Supply Status 2-4

Support, Technical Assistance Preface-16

System Checks

Data Screen 8-48

Expected Results 8-56

Maintenance Requests 8-10


Overview 8-45


Report 8-51


Results, Viewing 8-50


Running 8-53

Running (Flowchart) 8-52

Running Weekly 8-44

Inc. Index-13

Index-14


Safe Handling of Solution 8-53

Screen 8-46

Substrate : Washed Ratio 8-56

Substrate Ratio 8-56

System Command Buttons 1-20

Pause 1-20

Run 1-20

Stop 1-20

System Documentation Preface-3

System ID, Changing 7-7

System Modes 1-19

Not Ready 1-20

Paused 1-20

Ready 1-19

Running 1-20

System Navigation 1-26

Keyboard Equivalents 1-26

Select and Enter 1-27

System Overview 1-3

System Software, Overview 1-13


Descriptions 1-21

Event Log 1-23

Help 1-23

Liquid Waste 1-21


Represented in Documentation Preface-7

RV Waste Bag 1-22

RVs 1-22

Substrate 1-22

Supplies Required 1-23

Supply Conditions 2-3

Supply Status 2-4

Wash Buffer 1-21

Work Pending 1-23

TTechnical Support Preface-16

Temperatures


Equilibrating Substrate 2-22

Maintenance Review Screen 8-6

Test Menus

Calibration 3-41

Patient Samples 3-32

QC 3-46

Test Request, LIS

See LIS Test Requests

Test Requests

Adding and Deleting Restriction 4-3

Adding to On-Board Samples Using Pause Button 3-56

Calibration 3-38, 3-40

Deleting for On-Board Samples 3-54

Deleting for On-Board Samples (Flowchart) 3-53

Editing for On-Board Samples (Flowchart) 3-51

Editing While Samples On-Board 3-52

Entering for Patient Manually 3-31

Entering for Patient Manually (Flowchart) 3-30

Entering Quality Controls 3-45


Patient 3-19

Processing LIS Patient 3-27


Rerunning from Test Results 5-24


Screen 3-20

Screen Navigation 3-26

Test Result Flags

Details 5-25

Overriding Supply Conditions 4-16, 4-17

Overview 5-27

Test Results 5-1


Configuring Screen 5-28

Configuring Screen (Flowchart) 5-28

Copying to Disk 5-36

Copying to Disk or USB Flash Drive (Flowchart) 5-35

Defining a Filter 5-19

Defining a Filter (Flowchart) 5-18

Deleting 5-41

Deleting (Flowchart) 5-40

Deleting a Filter 5-20

Editing a Filter 5-15

Filters 5-9

Finding 5-22

Finding (Flowchart) 5-22




Flowchart 5-3

Managing Result Data 5-31

Overview 5-2


Printing Reports (Flowchart) 5-44

Reports 5-42

Rerunning a Test 5-24

Reviewing 5-9

Reviewing Flags 5-27

Screen 5-4

Selecting 5-7

Sending to the LIS 5-32

Viewing Sample Details 5-25

Viewing Sample Details (Flowchart) 5-25

Test Status

Monitoring 4-27

Test Result Descriptions 4-27

Test Results Screen 5-5

Testing, Reflex

See Reflex Tests

Tests

Deleting from Work Pending 4-23

Monitoring Status 4-27

Reflex Sample Processing 4-3

Requesting 3-19

Rerunning 5-24

Result Reports 5-42

Work Pending 4-19

Tubes

Elevated A-3

With Insert Cups A-8

With Separator Gel A-3

UUnloading

Racks 3-12

Reagent Packs 2-37

Unwashed Check, Expected Results 8-56

USB Flash Drives

See Flash Drives

User Interface (UI) Software 1-13

Utility Assay

After Stopping Sample Processing 4-6

Disabling 8-8

Enabling 8-8

Maintenance Review Screen 8-5


Running 8-6

Running Automatically 4-5

RV Requirements 8-7

VVerifying

Calibrations for Processing 4-11

Supplies for Processing 4-11

Vessels

See RVs

Vitamin B12 Assay


Running Special Clean 8-10


Volumes

Calculating Sufficient Sample A-6

Dead A-8

Insufficient Sample 3-6

Sample Required A-2, A-6

WWarnings

Citranox Handling 8-16

Contrad Handling 8-16

Indicators of Harm Preface-16

Instrument 1-8

Sodium Azide 1-8

System Check Handling 8-53

Wash Buffer Handling 2-10

Warranty

Required Routine Maintenance 1-5

System 1-5

Wash Buffer

Bottle 2-10, 2-12

Button 2-10

Changing the Bottle 2-11, 2-12


Contamination 2-11

Mixing 2-11

Reservoir 2-10, 2-12

Reservoir Overflow 2-12

Safe Handling 2-10

Inc. Index-15

Index-16


Supplies 2-3

Supplies Overview 2-10

Supply Status 2-3

Verifying Supply 4-11

Wash Buffer Valve Assembly 2-12

Wash Efficiency, Expected Results 8-56

Washed Check, Expected Results 8-56

Waste Containers


Liquid Waste Bottle 2-13

RV Waste Bag 2-28

Supplies 2-3

Waste Filter Bottle

Checking for Fluid 8-31

Checking for Fluid (Flowchart) 8-31

Waste Handling

Changing the RV Bag 2-29

Liquid 2-13, 2-15

RV Waste Bag 2-28

Waste, Liquid

See Liquid Waste

Weekly Maintenance

Checking for Fluid in the Waste Filter Bottle (Flowchart) 8-31

Checking for Waste Fluid 8-31

Cleaning Aspirate Probes 8-38

Cleaning the Aspirate Probes with Contrad 70 Cleaning Solution (Flowchart) 8-41

Cleaning the Aspirate Probes with Distilled Water (Flowchart) 8-43

Cleaning the Instrument Exterior 8-30

Cleaning the Primary Probe Exterior (Flowchart) 8-32

Daily Maintenance Portion 8-44

Flowchart 8-28

Inspecting the Liquid Waste Bottle 8-30

Overview 8-27

Precleaning the Aspirate Probes (Flowchart) 8-39

Primary Probe Inspecting and Cleaning

8-32

Replacing the Aspirate Probes 8-35

Replacing the Aspirate Probes (Flowchart) 8-34


System Check Portion 8-44

System Checks 8-45

Westgard QC Rules

Adding for Quality Controls 7-34

Description 7-9

Editing for Quality Controls 7-37

Points Violating Rules 7-13

Quality Control Overview 7-3

Reviewing Charts and Data 7-9

Rules Applied 7-14

Setting Up Quality Controls 7-31

Window Button Bar in Help Preface-12

Window View Button Preface-10

Windows

Add Calibrator 6-26

Add Control (QC) 7-35

Change Substrate 2-19

Common 1-27

Configure Screen (Test Results) 5-29

Copy to Disk (Test Results) 5-37

Edit Filter (Test Results) 5-15

Filter (Calibration) 6-6

Filter (QC Chart and Data) 7-16

Filter (Quality Controls) 7-7

Filter (Reagent Inventory) 2-46

Filter (Test Results) 5-12

Filter (Work Pending) 4-22

Find (Test Result) 5-23

Help Preface-11

Help Topics Preface-13

Help Topics (Find View) Preface-15

Load Reagent Pack 2-34

Overview 1-27

Print (QC Chart and Data) 7-28

Print (Test Result Reports) 5-46

Request Calibration 3-40

Request Maintenance 8-9

Request QC 3-45

Sample Details (Test Results) 5-26

Send to LIS (Test Results) 5-33

Specify a Date Range (Test Results Filter) 5-20

Work Pending


Deleting Tests 4-23

Overview 4-19





Report 4-24

Screen 4-20

Workpool, LIS

See LIS Workpool

Worksheets

Quality Control 7-42, 7-43

Inc. Index-17

Index-18Printed in U.S.A.



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