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Operator's Guide

P/N B14251E
February 2015

Printed in U.S.A.
© 2015 Beckman Coulter, Inc.
BECKMAN COULTER, INC. • 250 S. KRAEMER BLVD. • BREA, CA 92821 • U.S.A.
Publication This manual, P/N B14251E, release date 2/15, supports Access 2 system software
Notes 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

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

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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

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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

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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

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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

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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

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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

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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

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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

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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 the
Primary 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

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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

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About This This Operator’s Guide provides the step-by-step information needed for everyday
Manual 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 1 • General overviews of the Access 2 system, the
System Overview instrument, the software, and the safety features
Chapter 2 • How to view on-board supply status, replenish
Supplies supplies, and empty or replace waste containers
• How to view open reagent pack inventory
Chapter 3 • How to load, unload, and clear racks
Sample
Management
• 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 4 • How to start, pause, stop, and monitor sample
Sample Processing processing
• How to verify supply and calibration conditions
before running tests
• How to process work pending
Chapter 5 • How to view, interpret, and work with test results
Test Results

Chapter 6 • How to review calibration data for the instrument and


Assay Calibrations set up calibrators for all instruments in the workgroup
Chapter 7 • How to review quality control data and set up quality
Quality Controls controls for all the instruments in the workgroup
Chapter 8 • How to perform daily and weekly maintenance
Routine
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

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Appendix A • How to attach bar code labels to racks and sample


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

Table 1 Operator’s Guide Chapters (continued)

Other In addition to this Operator’s Guide, the following printed and online documentation
Access 2 is available for the Access 2 system.
System
Documen- Reference Manual
tation
The Reference Manual provides background, theory, troubleshooting, and advanced
maintenance information. The Reference Manual contains the following chapters:

Preface • A listing of the Access 2 system documentation


• Information about contacting Technical Support
Chapter 1 • Technical overviews of the Access 2 system and its
Technology hardware modules
Overview
• Overview of the immunoassay technology used by the
system to detect and measure analytes
Chapter 2 • Access 2 system spatial requirements, operating
System environment requirements, and electrical requirements
Specifications
• Component performance characteristics, system and
supply capacities, bar code sample requirements, and
other specifications
Chapter 3 • Theory of sample processing, including typical
Theory of Operation 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

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Chapter 4 • How to configure general system parameters for your


System laboratory, including report, printer, back up
Configuration 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 5 • How to initialize the system, prime the fluidics, and
Diagnostics perform dispense and aspirate volume checks
• How to view and perform diagnostic checks on
mechanical, analog, and digital devices, and the LIS
Chapter 6 • How to review and troubleshoot caution and warning
Event Log events
• Numeric list of cautions and warnings by system
module
Chapter 7 • How to service the instrument as needed for
System Support troubleshooting or as directed by Technical Support
Procedures

Appendix A • How to troubleshoot general instrument operation


Troubleshooting problems and out-of-range System Check routine
results
• How to troubleshoot out-of-range assay calibration,
quality control, and patient sample results
Appendix B • Details about which procedures you can perform on
System and Mode the workgroup instruments and which procedures you
Availability Tables 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)

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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 General information about how to use the system,
Immunoassay 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 The same procedural information provided in this
Procedures 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)

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Forms/Logs/ Illustrations of all suggested forms and worksheets


Worksheets you can use to record Access 2 activity.
Reports Illustrations of all system reports in alphabetical order.
Screens/Menus/ Illustrations and field descriptions of all screens and
Windows menus (alphabetized in one book) and complex
windows (alphabetized in another book).

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

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 To make information easier for you to find and use, Access 2 system documentation
Manual 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.

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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:

1 Select Filter F1. (text button)

1 Select Run. (system command button)

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

1 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:

1 Press [Print Screen]. (key name)

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

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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:

1 This is the first required step in a procedure.

2 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 When you select the Help from any Access 2 system software screen, a Help window
System 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.

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Help
Description
Access

On screens, the Help button is the round system status button with a
question mark (?).
Help
A screen also has function buttons, a Menu tab, system command
from a
Screen 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.
In windows, the Help button is the rectangular Help F12 function
button in the lower right corner.
Help A window may provide information about the status of the system or
from a ask you a question that requires your response. For more information
Window 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.
From any displayed Help topic, you can go to other topics using Help
Help navigational features such as Help link buttons, the Help window
from
Help button bar, the Help Topics window (tabs), the [F12] Help key on the
keyboard, and the highlighted text (green).

Table 4 Help System Access

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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

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Button Description

(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.

Table 5 Help Button Descriptions (continued)

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.

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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

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Exit (Button) Select to exit the Help system.


Help Window The Help window menu contains features that are duplicates
Menu 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)

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.

Select a topic
page to
display

Select a topic
book to
display the
contents

0603b.bmp
Figure 8 Help Topics Window (Contents View)

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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

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.

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• 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.

0857b.bmp
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

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

Help Manual
Description
Icon Graphic

(Note icon) Notes highlight or provide additional


NOTE information.

(Caution icon) Cautions emphasize the possibility


CAUTION of damage to the instrument.

(Warning icon) Warnings emphasize the


WARNING 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

Technical For technical assistance with the Access 2 Immunoassay System:


Support • 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.

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Access 2 Operator’s Guide 1: System Overview

1
System 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

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

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

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

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

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1.1
System 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.

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1.2
Instrument 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

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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 The Access 2 Immunoassay System is designed to meet U.S. and international safety
Features 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

WARNING
Do 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.

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Safety Certain areas of the Access 2 instrument present a risk of personal injury or damage to
Symbols and the instrument if proper safety procedures are not followed. These areas are marked
Statements 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

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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.

2184A.eps
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.

2185A.eps
Figure 1-5 Moving Parts Symbol

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Electrostatic Discharge Symbol


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

2192A.eps
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.

2208A.eps
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.

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Regulatory The Access 2 Immunoassay System meets the requirements of a variety of domestic
Symbols and and international regulatory agencies, standards, and directives. This compliance is
Statements 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.

C US
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

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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

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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.

XXXXXX-XX

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.

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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.

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Access 2 Operator’s Guide 1.3: Software Overview

1.3
Software 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.

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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 Only the Access 2 software should be installed on your PC. If a software application
Applications 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.

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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

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Main Menu Function Button Description

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)

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Main Menu Function Button Description

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)

Main Menu Select one of the Main Menu function buttons to display its associated screen. Across
Workflow 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.

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F1 Load Rack /
Get/Edit Rack
F2 Delete Sample
F3 Show/Hide
F1 Load a Rack
Test Menu
F2 Work Pending
F4 Test Results
F3 Test Request
Sample Manager F5 Request QC
F4 Maintenance Request
F1 F6 Request
F6 Get Selected Rack
Calibration
F7 Clear Selected Rack
F7 Clear All
F8 Change Rack ID
Samples
F8 More Options F1 Filter
F2 Review Data
Calibration
F5 Calibrator Setup
F5
F6 Delete
F7 Print
F1 Filter
F2 Find
F3 Rerun Test
F4 Sample Details
F5 Send to LIS
Test Results
F6 Copy to Disk
F2 F1 Report
F7 Print
F2 Completed Samples

F1 Refresh Screen
F2 Configure Screen F2 System Checks
F8 More Options
F3 Delete Data F5 Run Utility Assay
Maintenance Review
F6 Enable/Disable Utility
F6
Assay
F7 Print

F1 Load Reagent Pack


F2 Unload Reagent Pack
Supplies F4 Load RVs F1 Load F1 Mechanics
F1 Initialize System
F3 F5 Change Substrate Reagent Pack F2 Analog Devices
F2 Prime Fluidics
F6 Change RV Waste Bag F2 Unload F3 Digital Devices
F3 Volume Checks
F7 Reagent Inventory Reagent Pack F4 Luminometer
F4 Device Diagnostics
F5 Delete Pack F5 Ultrasonics
F7 Print F6 Exerciser
F8 Filter F7 Calibrate
Incubator Belt
Diagnostics
F7
F1 LIS Setup
F3 Loopback
Check
F5 LIS F4 Query for
F6 Copy to Disk Test Requests
F7 Diagnostic Reports F6 Copy to Disk
F8 Clear Screen

F1 System Revisions
F1 Filter F2 Bar Code
F2 Review Chart Reader Setup
and Data F1 System Setup F3 Set Workgroup
Quality Control
F3 Compare Charts Date/Time
F4
F4 Delete Comparison F5 Password Setup
F5 QC Setup F7 Reports Setup
F7 Print
F1 Filter
F2 Edit Units
F3 Ranges
Configure F2 Tests F4 Gray Zone
F8 F5 Special
F7 Print
F8 Update APF
F3 Test Panels
F4 Derived Results
F1 Scheduled Backup
F5 Reflex Tests
F2 Immediate Backup
F6 LIS
F3 Eject Tape
F7 PC Admin
F4 Restore
F8 About Access 2
F5 Auto-Delete Setup
F8 Shut Down PC

0863D.wmf
Figure 1-17 Main Menu Work Flow

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

System Status Buttons


System Mode

System
Command
Buttons

Scroll
Bar

Back
Tab

Menu
Tab

Status
Line
Function
Buttons

0711B.bmp
Figure 1-18 Common Access 2 System Screen Elements

System The Access 2 system has four system modes (see Table 1-19) that indicate the
Modes 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.

Mode Screen Display Description

Ready The system is ready to begin


processing samples.

Table 1-19 System Modes

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Mode Screen Display Description

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 The system is not ready to process


Ready samples. The system is checking the
status of subsystems, initializing
motors, priming fluid lines, homing
movable parts, warming necessary
modules, or requires initialization.

Table 1-19 System Modes (continued)

System You use the three system command buttons (see Table 1-20) to run, pause, and stop
Command the Access 2 instrument.
Buttons
Button Screen Description
Display

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

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System Status There are ten system status buttons. You can use these buttons to:
Buttons • 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
Description Button Colors
Button

Wash Buffer Select to view the status of the wash Red


buffer bottle. You can change the wash The wash buffer reservoir is almost
buffer bottle at any time during sample empty, and no new tests can be
processing. scheduled. You must change the wash
For more information about how to buffer bottle to continue processing
change wash buffer, see Section 2.2: tests.
Wash Buffer.
Liquid Waste Select to view the status of the liquid Red
waste bottle. You can change the liquid The liquid waste bottle is full, and no
waste bottle at any time during sample new tests can be scheduled. You must
processing. change the liquid waste bottle to
For more information about how to continue processing tests.
change the liquid waste bottle, see
Section 2.3: Liquid Waste.

Table 1-21 System Status Buttons

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System Status
Description Button Colors
Button

Substrate Select to display the Supplies screen to Yellow


check the level of on-board substrate, or The system can process 60 or fewer test
change the substrate bottle. You can requests with the remaining substrate.
only change the substrate bottle while Change the bottle at your next
the system is in the Ready mode. opportunity.
For more information about how to Red
change the substrate bottle, see The substrate bottle is empty, and no
Section 2.4: Substrate. new tests can be scheduled. You must
change the substrate bottle to continue
processing tests.
Reaction Vessels Select to display the Supplies screen to Yellow
(RVs) check on the RV supply, or load an RV The system can process 60 or fewer test
cartridge. You can load RVs at any time requests with the remaining RVs. Load
during sample processing. an RV cartridge now, or at your next
For more information about how to load opportunity.
RVs, see Section 2.5: Reaction Vessels Red
(RVs). 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 Yellow
check on the RV waste bag capacity, or The system can process 60 or fewer test
change the RV waste bag. requests with the remaining capacity in
For more information about how the waste bag. Change the RV waste
change the RV waste bag, see bag at your next opportunity.
Section 2.6: Reaction Vessel Waste Red
Bag. 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 Red
screen to setup quality controls, or A QC result is not within the acceptable
review quality control results. range of expected values. You should
For information about quality controls, review this result as soon as possible.
see Chapter 7: Quality Controls.

Table 1-21 System Status Buttons (continued)

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System Status
Description Button Colors
Button

Event Log Select to display the Event Log screen Yellow


for information about events generated The system has generated a caution
by the Access 2 system. From the Event event that requires your attention.
Log screen you can also display Red
troubleshooting information about The system has generated a warning
caution or warning events. event, indicating a serious fault or error
For information about the Event Log, condition has occurred.
see Chapter 6: Event Log in the
Reference Manual.
Work Pending Select to display the Work Pending Yellow
screen for information about samples A sample required condition has
for which the system cannot schedule occurred. You should load the required
tests. The Work Pending screen allows sample, or delete it from the work list.
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.
Supplies Required Select to display the Supplies Required Yellow
screen for information about supply and The system requires supplies or
calibration conditions. You can correct calibration(s) to complete the requested
most conditions from the Supplies tests.
Required screen.
For more information about the
Supplies Required screen, see
Chapter 4: Sample Processing.
Help Select to display specific information The Help button color is always neutral.
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.

Table 1-21 System Status Buttons (continued)

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

0649A.bmp 0650A.bmp

Figure 1-22 Back and Menu Tabs

Function The Access 2 system displays a row of eight function buttons across the bottom of
Buttons 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.

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Function Button Description


Example

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

Information Some screens require that you enter pertinent information into a field. You can only
Fields 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.

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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

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 The Access 2 system has three navigation methods that you can use in any
Navigation 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.

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Action Keyboard Equivalent

Perform the indicated function or [F1] - [F8]


go to the indicated screen
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

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 The Access 2 system displays a window to provide information, ask you to respond to
Windows 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.

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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.

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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.

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4 5
3 Laboratories, Inc.
6
Laboratory A

Report Name
123 Lake Street
Townsville, ST 3333 7
Access 2 Immunoassay System 101-555-2323 ext. 109 8
S/N 501240 Jane Smith

2
1 9

10

QNS = sample quantity not sufficient, ORL = result below reference range, ORH = result above reference range,
LEX = reagent pack lot expired 11
13 12
Page 1 of 1
Technologist Printed 10-10-00 2:43pm

0745B.eps

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

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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)

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Access 2 Operator’s Guide 2: Supplies

2
Supplies
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

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

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

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

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2.1
Supplies
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.

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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.

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

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


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

2 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.

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3 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.

4 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.

5 Select Done F1.

Scanning a Bar Code with the Other Handheld Reader


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

2 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.

3 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.

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

5 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.

6 Select Done F1.

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Supplies Screen
You 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.

Substrate Button RVs Button RV Waste Bag Button

0575A.bmp 0576A.bmp 0577A.bmp

0631D.bmp
Figure 2-1 Supplies Screen

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Reagent Pack (24 Buttons) Correspond to the 24 available slots in the reagent carousel of the
Button 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

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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 (Button) Select to display the Load Reagent Pack window.
F1
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 (Button) Select to unload a reagent pack.
Pack F2
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)

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Access 2 Operator’s Guide 2.1: Supplies

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 (Button) Select to change the substrate bottle.
F5
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 (Button) Select to change the RV waste bag.
Bag F6
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 (Button) Select to display the Reagent Inventory screen. You use this screen to:
F7
• View the reagent inventory
• Load and unload reagent packs
• 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)

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2.2: Wash Buffer Access 2 Operator’s Guide

2.2
Wash Buffer

WARNING
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.

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.

The wash buffer bottle drains into an internal wash buffer Wash Buffer
reservoir. When the wash buffer bottle is visibly empty, but before Button
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 0573A.bmp

Wash Buffer button does not turn yellow.

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.

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

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

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

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Access 2 Operator’s Guide 2.2: Wash Buffer

Gently invert new


wash buffer bottle
3 or 4 times

Remove cap and inner


seal from new bottle

Remove empty bottle

Remove dispense
cap assembly from
empty bottle

Attach dispense cap


assembly to new bottle

Turn new bottle upside


down and place into
reservoir receptacle

0588B.wmf
Figure 2-3 Changing the Wash Buffer Bottle Flowchart

Changing the Use this procedure to change the wash buffer bottle (see Figure 2-4).
Wash Buffer
Bottle WARNING
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.

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

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

3 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.

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

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2.2: Wash Buffer Access 2 Operator’s Guide

5 Screw the dispense cap assembly on the new bottle.

6 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.

2b 2
2a

3
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

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Access 2 Operator’s Guide 2.3: Liquid Waste

2.3
Liquid Waste
Liquid waste is any fluid removed from the Access 2 system.

WARNING
Consider 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.

The system monitors the volume in the on-board liquid waste Liquid Waste
bottle with a weight sensor. The Liquid Waste button turns red Button
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
0574A.bmp
yellow.

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

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

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2.3: Liquid Waste Access 2 Operator’s Guide

Loosen cap of full


liquid waste bottle

Stopped
Remove bottle cap and
Processing No insert in clean bottle
samples?

Yes

Release the quick


disconnects from full
bottle

Connect quick
disconnects to empty
liquid waste bottle

Remove full liquid


waste bottle and place
clean bottle in fluids tray

Decontaminate
contents of full liquid
waste bottle

Dispose of liquid waste


and rinse bottle
thoroughly

Store clean bottle for


future use

0589C.wmf
Figure 2-5 Changing the Liquid Waste Bottle Flowchart

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Access 2 Operator’s Guide 2.3: Liquid Waste

Changing the Use this procedure to change the liquid waste bottle. To minimize contact with liquid
Liquid Waste waste, do not change the liquid waste bottle while the system is processing samples.
Bottle
WARNING
You 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.

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

2 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.

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

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

5 Dispose of the liquid waste.

6 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.

WARNING
Thoroughly 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.

7 Store the clean liquid waste bottle for future use.

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2.3: Liquid Waste Access 2 Operator’s Guide

0229C.eps

1 Liquid Waste Bottle


2 Quick Disconnects

Figure 2-6 Liquid Waste Bottle

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Access 2 Operator’s Guide 2.4: Substrate

2.4
Substrate
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.

When the system can process 60 or fewer tests with the current Substrate Button
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
0575Ac.bmp
system is in the Ready mode.

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.

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2.4: Substrate Access 2 Operator’s Guide

any screen

Supplies

Change Substrate
F5

Change Substrate

Scan the new,


equilibrated substrate
bottle

Replace cap on new


substrate bottle
with cap from old
substrate bottle

Discard empty bottle


and equilibrate new
bottle prior to use

Done
F1

Yes
F1

System primes the


substrate fluidic lines

0505A.wmf
Figure 2-7 Changing the Substrate Bottle Flowchart

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Access 2 Operator’s Guide 2.4: Substrate

Changing the Use this procedure to change the substrate bottle.


Substrate
Bottle CAUTION
Do not combine partial bottles of substrate.

1 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.

2 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

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2.4: Substrate Access 2 Operator’s Guide

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 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.

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

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Access 2 Operator’s Guide 2.4: Substrate

1 2

0228C.eps

1 Substrate Bottle in Use


2 Substrate Bottle Equilibrating to Room Temperature for Next Use

Figure 2-10 Substrate Bottles

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

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

1 2

1058A.eps

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2.4: Substrate Access 2 Operator’s Guide

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 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

8 Put the new bottle back in the fluids tray.

9 Select Done F1.


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

10 Select Yes F1.


The system primes the substrate fluidic lines.

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

12 Put an unopened bottle of substrate in the fluids tray so it can equilibrate to


room temperature.

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Access 2 Operator’s Guide 2.4: Substrate

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.

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

2.5
Reaction 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 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 0576Ac.bmp

another sample until you load a new RV cartridge onto the


instrument.

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

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

any screen

Supplies

Load RVs
F4

Load RVs

Remove cartridge
cover, load cartridge,
remove empty spine

Done
F1

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.

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

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

2 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.

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

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

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

6 Open the RV load door.

7 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)

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

9 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.

10 Close the RV load door.

11 Close the supplies door.

12 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

2.6
Reaction 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 the waste bag has room for 60 or fewer RVs, the RV Waste Bag Button
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
0577A.bmp
bag.

When you install a new RV waste bag, the system resets the RV counter.

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

For more information about how RVs move through the system, see Section 3.1:
Sample Processing Theory in the Reference Manual.

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Access 2 Operator’s Guide 2.6: Reaction Vessel Waste Bag

any screen

Supplies

Change RV Waste Bag


F6

Change RV Waste Bag

Open supplies door,


unfold and expand
new bag

Remove and seal old


bag, insert new bag,
and close the
supplies door

Done
F1

0507A.wmf
Figure 2-15 Changing the RV Waste Bag Flowchart

Changing the Use this procedure to change the RV waste bag.


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

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.

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2.6: Reaction Vessel Waste Bag Access 2 Operator’s Guide

1 Go to the Supplies screen. To get to this screen from any screen, select the RV
Waste Bag button.

2 Select Change RV Waste Bag F6.


The Change RV Waste Bag window is displayed.

3 Open the supplies door on the front of the instrument.

4 Unfold a new waste bag, grasp its sides, and pull gently to expand it.

5 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.

6 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.

7 Discard the used biohazardous waste bag.

8 Close the supplies door.

9 Select Done F1.


The Supplies screen updates the RV waste capacity.

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Access 2 Operator’s Guide 2.7: Reagent Packs

2.7
Reagent 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.

The Access 2 system monitors the number of tests processed Supplies Required
using each reagent pack. When an on-board reagent pack does Button
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, 0578A.bmp
the system takes the requested tests out of Supplies Required
status and begins processing them.

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.

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

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2.7: Reagent Packs Access 2 Operator’s Guide

You can load a reagent


pack from the Supplies Or from the Main Menu
Required screen

any screen Main Menu

Supplies
F3
You can also load a
Supplies Required Supplies reagent pack from the
Reagent Inventory
screen

Load Reagent Pack Load Reagent Pack Reagent Inventory


F1 F1 F7

Load Reagent Pack Reagent Inventory

Load Reagent Pack


F1

Invert unpunctured pack


several times

Insert reagent pack,


scan reagent pack

Done
F1

0502C.wmf
Figure 2-16 Loading a Reagent Pack Flowchart

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Access 2 Operator’s Guide 2.7: Reagent Packs

Loading a Use this procedure to load a reagent pack onto the instrument.
Reagent Pack
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.

1 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.

2 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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2.7: Reagent Packs Access 2 Operator’s Guide

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

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Access 2 Operator’s Guide 2.7: Reagent Packs

3 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.

4 Slide the carousel door to the left to open it.

5 Open the reagent carousel door.

6 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.

2
1

4
5

6
0764B.eps

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

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2.7: Reagent Packs Access 2 Operator’s Guide

CAUTION
To prevent damaging the reagent pack, be sure it is properly seated in the
reagent carousel.

7 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.

a
b
E
tal Ig
To
c
6D
3F
8T
WM
d
e

0019F.eps
Figure 2-20 Scanning a Reagent Pack Bar Code with the Bar Code Wand

8 Close the reagent carousel door.

9 Slide the carousel door to the right to close it.

10 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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Access 2 Operator’s Guide 2.7: Reagent Packs

Main Menu

Supplies
F3

Supplies You can also unload a


reagent pack from the
Reagent Inventory screen

Unload Reagent Pack Reagent Inventory


F2 F7

Unload Reagent Pack Reagent Inventory

Unload Reagent Pack


F2

Remove reagent pack


from reagent carousel Unload Reagent Pack

Done
F1

Remove reagent pack


from reagent carousel

Done
F1

0503A.wmf - v1.7
Figure 2-21 Unloading a Reagent Pack Flowchart

Unloading a Use this procedure to unload a reagent pack from the instrument.
Reagent Pack
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.

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2.7: Reagent Packs Access 2 Operator’s Guide

WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
1 Go to the Supplies screen. To get to this screen from the Main Menu, select
Supplies F3.

2 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.

3 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.

4 Slide the carousel door to the left to open it.


5 Open the reagent carousel door.
6 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.
7 Close the reagent carousel door.
8 Slide the carousel door to the right to close it.
9 Select Done F1.
The system removes the pack from the Supplies screen but keeps the pack
information in the database.
10 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.
11 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 For the Access 2 system to accurately track the proper locations of reagent packs on
Misplaced the reagent carousel, the packs must be loaded and unloaded using the appropriate
Packs 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.

WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
1 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.

2 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.

3 Select Disable Motors F8.

4 Slide the carousel door to the left to open it, and then open the reagent carousel
door.

5 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.

6 After verifying that all packs are removed, close the reagent carousel door and
then slide the carousel door to the right to close it.

7 Select Enable Motors F8.

8 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.

9 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.

10 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

2.8
Reagent 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.

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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.

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

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2.8: Reagent Inventory Access 2 Operator’s Guide

Reagent Inventory Screen


You use the Reagent Inventory screen to:
• View the reagent packs inventory
• Load and unload reagent packs
• 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

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Access 2 Operator’s Guide 2.8: Reagent Inventory

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

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2.8: Reagent Inventory Access 2 Operator’s Guide

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.
Load Reagent Pack (Button) Select to load a reagent pack. When the instrument presents an empty
F1 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)

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Access 2 Operator’s Guide 2.8: Reagent Inventory

Unload Reagent (Button) Select to unload the selected reagent pack. When the instrument presents
Pack F2 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)

Applying a A filter is a set of parameters you can change to increase or decrease the number of
Filter to the reagent packs that display on the Reagent Inventory screen. A filter is always applied.
Reagent The default filter at system installation is all packs sorted by pack name on the
Inventory instrument the PC is attached to. Use this procedure to apply a different filter to the
Screen Reagent Inventory screen.

NOTE
The system uses the selected filter until you apply a different one.

1 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.

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2.8: Reagent Inventory Access 2 Operator’s Guide

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

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Access 2 Operator’s Guide 2.8: Reagent Inventory

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)

2 Select a filter criteria.


3 Select a sort order option.

NOTE
If you select the All Packs filter, the Carousel Slot option is not available.

4 Select one or more instruments in the workgroup.

5 Select or clear the Ascending option.

6 Select OK F1.

The Reagent Inventory screen displays the reagent packs according to the filter
criteria, sort order, and instruments you selected.

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2.8: Reagent Inventory Access 2 Operator’s Guide

Main Menu

Supplies
F3

Supplies

Reagent Inventory
F7

Reagent Inventory

Select the reagent pack


you want to delete

For more detailed information about


Reagent pack Unload the unloading a reagent pack, see the
No
off board? reagent pack Unloading a Reagent Pack
procedure in this chapter.

Yes

Delete Pack
F5

0508A.wmf
Figure 2-26 Deleting a Reagent Pack Flowchart

Deleting a Use this procedure to delete full or partially full off-board reagent packs from
Reagent Pack 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.

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Access 2 Operator’s Guide 2.8: Reagent Inventory

1 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.

2 Select the off-board reagent pack you want to delete.

3 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.

4 Select Delete Pack F5.


The system displays a window.

5 Select Yes F1.

The system deletes the reagent pack.

Printing the Use this procedure to print the Reagent Inventory Report, containing all selected
Reagent packs or all packs in the current filter.
Inventory
1 Go to the Reagent Inventory screen. To get to this screen from any screen,
Report
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.

2 Select Print F7.


The system prints the Reagent Inventory Report (see Figure 2-27).

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2.8: Reagent Inventory Access 2 Operator’s Guide

Laboratories, Inc.
Laboratory A
123 Lake Street
Townsville, ST 33333
Reagent Inventory Report 101-555-2323 ext. 109
Access 2 Immunoassay System Jane Smith

Filter: All Packs -- Sorted by Test Name


Test Name Lot No. Serial No. Tests Days Pack Calib. Slot Instrument
Left Open Expiration Expiration
PSA-Hyb 066851 3461 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

Page 1 of 1
Technologist______________________________ Printed 04/04/06 02:43 PM

0746C.bmp
Figure 2-27 Reagent Inventory Report

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Access 2 Operator’s Guide 3: Sample Management

3
Sample 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

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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

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Access 2 Operator’s Guide 3.1: Sample Management

3.1
Sample 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.

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3.1: Sample Management Access 2 Operator’s Guide

Place samples
on racks

Main Menu

Sample Manager
F1

Sample Manager

Are
sample IDs
read by internal Test Request
No Enter a rack ID
F3
bar code
reader?
Test Requests
Yes

Load a Rack Enter sample IDs


F1

Load Rack [X]


F1
Load rack and select
Done F1

Load rack and select


Done F1

Test Request
Using LIS? No F3

Test Requests No Using LIS?


Yes

Enter test requests


Yes

All racks
No loaded? All racks
loaded?
No

Yes
Yes
Run
Run

0619D.wmf
Figure 3-1 Sample Management Flowchart

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Access 2 Operator’s Guide 3.1: Sample Management

Sample Manager Screen


You 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

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3.1: Sample Management Access 2 Operator’s Guide

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

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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)

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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 (Button) Select to display the Request Maintenance window. You use this window
Request F4 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 (Button) After you select a rack from the On Board list, select to get the rack from
F6 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.

Table 3-3 Sample Manager Screen Descriptions (continued)

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Clear Selected Rack (Button) After you select a rack from the Off Board list, select to delete all
F7 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.

Table 3-3 Sample Manager Screen Descriptions (continued)

Placing Place all samples to be tested on the Access 2 system in racks before loading them
Sample onto the instrument. The rack ID on each rack identifies what type of sample
Containers in containers you may use in that rack. Each rack holds up to ten sample containers.
Racks 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.

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.
• 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.

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• 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 Use this procedure to load an off-board rack onto the instrument.
Racks
WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.

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

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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.

1 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.

2 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.

3 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

1 Rack Peg and Carousel Notch

Figure 3-4 Loading Racks

4 Select Done F1.

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The rack and samples are scanned.

 (Optional) To load another rack, repeat step 2 through step 4.

5 Close the sample carousel door.

6 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 Use this procedure to unload an on-board rack.


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

1 Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.

2 In the On Board list, select the rack you want to unload.

3 Select Get Selected Rack F6.


If the system is processing samples, it enters the Paused mode.

If the rack status The system...


is...
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 or Presents the rack and displays the Get Selected Rack
Supply Wait window with a status message.
To stop unloading the rack, select Cancel F8. Otherwise,
continue with step 4.

Table 3-5 Rack Status

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If the rack status The system...


is...

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.
To stop unloading the rack, select Cancel F8. Otherwise,
continue with step 4.
Aspirated Presents the rack and displays the Get Selected Rack
window with a warning message.
To stop unloading the rack, select Cancel F8. Otherwise,
continue with step 4.
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.

Table 3-5 Rack Status (continued)

4 Open the sample carousel door, then unload the rack by holding onto the rack
handle and lifting upward.

5 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.

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If the rack you unloaded... The system...

Has no test requests associated with Automatically clears the rack.


it
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.

 (Optional) To unload another rack, repeat step 2 through step 5.

6 Close the sample carousel door.

7 To continue sample processing, select Run.


For more information about Sample Processing, see Chapter 4: Sample
Processing.

Resolving If a sample error occurs after you load a rack, the system turns the affected sample
Sample Errors 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.

1 Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.

2 In the On Board list, look for red sample containers in the rack icon and select a
rack icon with a sample error.

3 Select Test Request F3 to display the Test Requests screen.

4 Look for error messages in the Status field of the sample in error.

5 Take the necessary action to resolve the sample error. For more information, see
Appendix A: Troubleshooting in the Reference Manual.

6 To continue sample processing, select Run.


If you resolved the error, the system clears the error indicators.

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Changing Use this procedure to change the rack ID of an off-board rack.


Rack IDs
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.

1 Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.

2 In the Off Board list, select the rack you want to change.

3 Select Change Rack ID F8.


The Change Rack ID window is displayed.

4 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.

5 Select OK F1.
A confirmation window is displayed.

6 Select OK F1 to change the rack ID.


The system changes the rack ID on the rack button.

Clearing Use this procedure to clear a rack button from the Off Board list on the Sample
Racks 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

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ID associated with the test results from the database.

1 Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.

2 In the Off Board list, select the rack you want to clear.

3 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 Use this procedure to enter, edit, or delete comments for patient or quality control
Sample samples on the Test Requests screen.
Comments
1 Select the Pen or Notepad button to display the Sample Comment window.

The pen indicates no comments are associated with the sample.

The notepad indicates comments are associated with the sample.

2 In the Comment field, enter or edit comments. Or, to delete an existing


comment, select it and press [Backspace].

3 To save comments, select OK F1.

Changing the Use this procedure to change or set a reagent lot number for a calibration or quality
Reagent Lot control test request from the Test Requests screen. You can only change or set a
for Running reagent lot number when the reagent lot is in inventory and the sample status is
Calibrations Requested. To add a lot to the reagent pack inventory, load the reagent pack. For
or Controls 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.

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1 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.

2 On the Test menu, select Change Reag. Lot to display the Set Reagent Lot
window.

3 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.

1 From the Test Requests screen, select the quality control for which you want to
set a reagent lot.

2 Confirm that the Test menu is displayed.


• If the Test menu is not displayed, select Show Test Menu F3.

3 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.
4 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.

5 The reagent lot for the selected test is set. To set the lot for another test or
quality control, repeat this procedure.

Requesting Technical Support representatives use service assays for instrument diagnostics.
Service
Assays NOTE
Use this window only as directed by your technical support representative.

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3.2
Patient 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.

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Test Requests Screen


You 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.

Rack Location Rack ID Rack Icon Rack Status

Position

Selected
Sample

Selected
Tests

0583D.bmp
Figure 3-6 Test Requests Screen

Rack Location (Field) Displays the location of the rack.


Values are: Unloaded, Loaded, and Scanned/Loaded.

Table 3-7 Test Requests Screen Descriptions

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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)

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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 (Field) For patient samples, enter an optional patient ID (1-15 alphanumeric
Number 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.

Table 3-7 Test Requests Screen Descriptions (continued)

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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.

Table 3-7 Test Requests Screen Descriptions (continued)

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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 (Button) X is the rack ID of the rack selected on the Sample Manager screen. If the
or selected rack is off board, select Load Rack X F1 to load it. If the selected rack is
Get/Edit Rack X F1
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 (Button) Select Show Test Menu F3 to display the Test menu. Select Hide Test
Menu F3 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.

Table 3-7 Test Requests Screen Descriptions (continued)

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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 Calibration (Button) For calibration samples, select to display the Request Calibration window.
F6 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 (Button) Select to clear all sample fields for the current rack.
F7

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.

Table 3-7 Test Requests Screen Descriptions (continued)

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Navigating If you are using the keyboard to navigate the Test Requests screen, the cursor
the Test movement on this screen is different from other screens.
Requests
When you go to the Test Requests screen, the cursor will be in the Sample ID field for
Screen
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.

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Access 2 Operator’s Guide 3.2: Patient Test Requests

Main Menu

Sample Manager
F1

Sample Manager

Place sample(s) in the rack

Load a Rack
F1

Load rack and select


Done F1

All racks
No
loaded?

Yes

System downloads
test requests from LIS

Verify downloaded
sample and test
information and make
any necessary changes

Run

0621C.wmf
Figure 3-8 Processing LIS Test Requests Flowchart

Processing LIS If you are using bar-coded sample containers and are downloading test requests from
Patient Test an LIS, use this procedure to load racks and run the tests. You can load up to six racks
Requests 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.

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• 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.

1 Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.

2 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.

3 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.

4 Load a rack (see the Loading Racks procedure in this chapter).

5 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.

6 Close the sample carousel door.

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7 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.

8 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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3.2: Patient Test Requests Access 2 Operator’s Guide

Main Menu

Sample Manager
F1

Sample Manager

Enter rack ID
or select rack button
from Off Board list
Test Request
F3

Test Requests

Enter sample ID, test


requests, and sample
information

Place samples
in racks

Load Rack X
F1

Load rack and select


Done F1

All racks
loaded? No Back

Yes

Run

0618D.wmf
Figure 3-9 Entering Patient Test Requests Manually Flowchart

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Entering If you have disabled sample bar code scanning, or need to enter test requests and
Patient Test sample information manually, use this procedure to manually enter test requests.
Requests
Manually 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.

1 Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.

2 Select the rack button from the Off Board list, or enter the rack ID in the Rack
ID field and press [Enter].

3 Select Test Request F3 to display the Test Requests screen.

4 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.

5 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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3.2: Patient Test Requests Access 2 Operator’s Guide

0697B.bmp
Figure 3-10 Test Menu (Patient Samples)

Tests Requested for (List) Displays test names selected to run on the sample (X is the selected sample
Sample X 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

6 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.

7 Place the samples in the rack. For information about how to do this, see the
Placing Sample Containers in Racks procedure in this chapter.

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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.

8 Select Load Rack X F1.

9 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.

10 To start sample processing, select Run.


For more information about sample processing, see Section 4.1: Sample
Processing.

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3.2: Patient Test Requests Access 2 Operator’s Guide

Main Menu

Sample Manager
F1

Sample Manager

Select or enter the rack ID


and press [Enter]

Test Request
F3

Test Requests

Enter sample ID
for first sample

More Options
F8
Turn Auto Sample ID On
F2

Enter test request


information

Add samples to rack


More samples? No
and load rack

Yes Run

Select the next sample


position

The system
automatically enters
the sample ID

0512C.wmf
Figure 3-12 Using Auto Sample ID Flowchart

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Access 2 Operator’s Guide 3.2: Patient Test Requests

Using Auto The Auto Sample ID option simplifies test request entry when you are not using
Sample ID 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.

1 Go to the Test Requests screen. To get to this screen from the Main Menu,
select Sample Manager F1.

2 Select or enter the rack ID and press [Enter].

3 Select Test Request F3. Type the sample ID for the first sample and press
[Enter].

4 Select More Options F8, then select Turn Auto Sample ID On F2.

5 Enter the rest of the test request information for the sample.

6 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.

7 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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3.2: Patient Test Requests Access 2 Operator’s Guide

Main Menu

Sample Manager
F1

Sample Manager

Select or enter the rack ID


and press [Enter]

Test Request
F3

Test Requests
Type sample ID for the first
sample and select tests to
run

More Options
F8
Turn Batch Request On
F1

Test Requests

Select next sample position

The system
automatically selects
same tests for
next sample

Done entering
samples?
No

Yes

Add samples to rack


and load rack

Run

0513C.wmf
Figure 3-13 Using Batch Request Flowchart

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Access 2 Operator’s Guide 3.2: Patient Test Requests

Using Batch The Batch Request option simplifies test request entry when you are not using an LIS
Request 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.

1 Go to the Test Requests screen. To get to this screen from the Main Menu,
select Sample Manager F1.
2 Select or enter the rack ID and press [Enter].
3 Select Test Request F3. Type the sample ID and enter the tests you want to
run, then press [Enter].
4 Select More Options F8, then Turn Batch Request On F1.
5 Enter the rest of the test request information for the sample.
6 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.
7 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 You must delete a sample ID from the system before it can be reused.
Sample IDs In order to reuse a sample ID, you must first complete the following steps.

1 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.
2 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.
3 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.
4 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

3.3
Calibration 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.

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Access 2 Operator’s Guide 3.3: Calibration Test Requests

Main Menu

Sample Manager
F1

Sample Manager

Select off-board rack or


enter rack ID and
press [Enter]
Test Request
F3

Test Requests

Request Calibration
F6

Request Calibration

Select calibration set

OK
F1

System enters calibration


set lot number, calibrator
levels, and reagent pack
lot number

Test Requests

System enters each


calibrator level in
subsequent sample positions
Load Rack X
F1

Add samples to rack and


load rack

Run

0510C.wmf
Figure 3-14 Entering Calibration Test Requests Flowchart

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3.3: Calibration Test Requests Access 2 Operator’s Guide

Entering Use this procedure to enter test requests for a set of calibration samples.
Calibration
Test Requests 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.

1 Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.

2 Select the rack button from the Off Board list, or enter the rack ID in the Rack
ID field and press [Enter].

3 Select Test Request F3 to display the Test Requests screen.

4 Select Request Calibration F6.


The Request Calibration window is displayed

2164B.bmp
Figure 3-15 Request Calibration Window

5 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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0698B.bmp
Figure 3-16 Test Menu (Calibration)

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

 (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.

6 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.

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.

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3.3: Calibration Test Requests Access 2 Operator’s Guide

7 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.

8 To start sample processing, select Run.

For more information about sample processing, see Section 4.1: Sample
Processing.

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Access 2 Operator’s Guide 3.4: Quality Control Test Requests

3.4
Quality 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.

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3.4: Quality Control Test Requests Access 2 Operator’s Guide

Main Menu

Sample Manager
F1

Sample Manager

Enter rack ID and press


[Enter]

Test Request
F3

Test Requests

Request QC
F5

Request QC

Select a single or multi-


level quality control
OK
F1

Test Requests

Load Rack X
F1

Add samples to rack


and load rack

Run

0511C.wmf
Figure 3-18 Entering Quality Control Test Requests Flowchart

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Access 2 Operator’s Guide 3.4: Quality Control Test Requests

Entering Use this procedure to enter a test request for a quality control sample or set of
Quality samples.
Control Test
1 Go to the Sample Manager screen. To get to this screen from the Main Menu,
Requests
select Sample Manager F1.

2 Select the rack button from the Off Board list, or enter the rack ID in the Rack
ID field and press [Enter].

3 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.

4 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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0699B.bmp
Figure 3-20 Test Menu (QC)

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 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.

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 (Optional) To enter or edit comments, select the Pen or Notepad button. For
more information, see the Entering Sample Comments procedure in this
chapter.

6 Place the QC samples in the rack(s). For more information, 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.

7 Load the rack(s). For more information, see the Loading Racks procedure in
this chapter.

8 To start sample processing, select Run.


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

3.5
Working 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.

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Access 2 Operator’s Guide 3.5: Working with On-Board Samples

Main Menu

Sample Manager
F1

Sample Manager

Enter rack ID and press


[Enter] or select rack from
the On Board list

Get Selected Rack


F6

Get Selected Rack

System presents the


rack

Open sample carousel


door, then add, remove,
or rearrange samples
and close door

Done
F1

Internal bar code reader


scans the rack for
changes

Run

0848B.wmf
Figure 3-22 Adding, Removing, and Rearranging On-Board Samples
Flowchart

Adding, Use this procedure to access an on-board rack so you can add, remove, or rearrange
Removing, samples.
and
Rearranging WARNING
On-Board You will come in contact with potentially infectious materials during this
Samples procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.

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3.5: Working with On-Board Samples Access 2 Operator’s Guide

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.

1 Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.

2 Select the rack you want to work with from the On Board list.

3 Select Get Selected Rack F6.


If the system is processing samples, it enters the Paused mode.
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.

4 Open the sample carousel door and add, remove, or rearrange samples. You do
not need to unload the rack.

5 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.

6 Close the sample carousel door.

7 To continue sample processing, select Run.


For more information about sample processing, see Section 4: Sample
Processing.

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Access 2 Operator’s Guide 3.5: Working with On-Board Samples

Main Menu

Sample Manager
F1

Sample Manager

Select rack button in On


Board list

Test Request
F3

Test Requests

Get/Edit Rack X F1

System
No processing
samples?

Yes

System enters
Paused mode

Test Requests

Edit test request information

All samples
No
edited?

Yes

Done
F1

Run

0514C.wmf
Figure 3-23 Editing Test Requests for On-Board Samples Flowchart

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3.5: Working with On-Board Samples Access 2 Operator’s Guide

Editing Test Use this procedure to edit a test request for a sample in an on-board rack.
Requests for
1 Go to the Sample Manager screen. To get to this screen from the Main Menu,
On-Board
select Sample Manager F1.
Samples
2 In the On Board list, select the rack with the test request to be edited.

3 Select Test Request F3.


The Test Requests screen is displayed.

4 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.

5 Select the sample position containing the test request to be edited.

6 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.

7 To start or continue sample processing, select Done F1, then select Run.
For more information about sample processing, see Section 4.1: Sample
Processing.

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Access 2 Operator’s Guide 3.5: Working with On-Board Samples

Main Menu

Sample Manager
F1

Sample Manager

Select rack with the sample


you want to delete a test
request from

Test Request
F3

Test Requests

Get/Edit Rack X
F1

Select the sample with


the test request to be
deleted

Select the test to be


deleted from the
Test Requested
for Sample X list

Remove
F2

Done
F1

Run

0517C.wmf
Figure 3-24 Deleting Test Requests for On-Board Samples Flowchart

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3.5: Working with On-Board Samples Access 2 Operator’s Guide

Deleting Test Use this procedure to delete a test request for a sample in an on-board rack.
Requests for
On-Board NOTE
Samples You can delete a test request only if the sample status is Requested, In
Progress, or Supply Wait.

1 Go to the Sample Manager screen.To get to this screen from the Main Menu,
select Sample Manager F1.

2 In the On Board list, select the rack containing the sample with the test request
to be deleted.

3 Select Test Request F3.


The Test Requests screen is displayed.

4 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.

5 Find the sample containing the test request to be deleted.

6 In the Test menu, select the test to be deleted from the Tests Requested for
Sample X list.

7 Select Remove F2.

 (Optional) To delete a calibration set, select Delete Sample F2.

8 To start or continue sample processing, select Done F1, then select Run.
For more information about sample processing, see Section 4.1: Sample
Processing.

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Access 2 Operator’s Guide 3.5: Working with On-Board Samples

Main Menu

Sample Manager
F1

Sample Manager

Select rack with the sample


you want to delete a test
request from

Test Request
F3

Test Requests

Get/Edit Rack X
F1

Select the sample with


the test request to be
deleted

Select the test to be


deleted from the
Test Requested
for Sample X list

Remove
F2

Done
F1

Run

0934B.wmf
Figure 3-25 Adding Test Requests to On-Board Samples Using the Pause Button Flowchart

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3.5: Working with On-Board Samples Access 2 Operator’s Guide

Adding Test Use this procedure to add a test request for a sample in an on-board rack using the
Requests to Pause button.
On-Board
Samples NOTE
Using the The instrument must be in the Running mode to use this procedure.
Pause Button
1 Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.

2 In the On Board list, select the rack containing the sample that requires
additional test requests.

3 Select Test Request F3.


The Test Requests screen is displayed.

4 Select Pause.
The system enters the Paused mode, but does not present the selected rack.

5 Select the sample that requires additional test requests.

6 In the Test menu, select the test(s) to be added to the sample.

7 To resume sample processing, select Run.

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Access 2 Operator’s Guide 3.5: Working with On-Board Samples

Main Menu

Sample Manager
F1

Sample Manager

Select rack from the On


Board list

Test Request
F3

Test Requests

Pause

Select sample
containing the test
request to be deleted

Select the test to be


deleted from the Test
menu

Remove
F2

Run

0935B.wmf
Figure 3-26 Deleting Test Requests from On-Board Samples Using the Pause Button Flowchart

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3.5: Working with On-Board Samples Access 2 Operator’s Guide

Deleting Test Use this procedure to delete a test request for a sample in an on-board rack using the
Requests from Pause button.
On-Board
Samples NOTE
Using the The instrument must be in the Running mode to use this procedure.
Pause Button
1 Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.

2 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.

3 Select Test Request F3.


The Test Requests screen is displayed.

4 Select Pause.
The system enters the Paused mode, but does not present the selected rack.

5 Select the sample with the test requests to be deleted.

6 In the Test menu, select the test to delete from the sample.

7 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.

8 To resume sample processing, select Run.

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Access 2 Operator’s Guide 4: Sample Processing

4
Sample 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

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4.1: Sample Processing Access 2 Operator’s Guide

4.1
Sample 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.

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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.

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4.1: Sample Processing Access 2 Operator’s Guide

Select Run if system is


not in Running mode
Run

(optional) (optional)
Monitor progress Supplies or
Samples Monitor progress
View results No calibration No
required? View results
Print results required?
Print results

Yes Yes

any screen any screen

Supplies Required Work Pending

Override
F8

Yes

(optional)
Override Apply filter
Correct the Load samples
No expired supply/ No
condition now? Delete samples
calibration?
Print report

Yes

Load supply,
change waste
container, or
request calibration

0518B.wmf
Figure 4-1 Processing Samples Flowchart

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Access 2 Operator’s Guide 4.1: Sample Processing

Starting Use this procedure to begin processing samples after you verify supplies, load
Sample samples, and enter or verify test request information.
Processing
1 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.

2 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 Use this procedure to temporarily pause the instrument when it is in the Running
Sample mode.
Processing
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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4.1: Sample Processing Access 2 Operator’s Guide

1 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 Use this procedure to stop sample processing.


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.

1 Select Stop from any screen.


A confirmation window is displayed.

2 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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Access 2 Operator’s Guide 4.1: Sample Processing

Sample When you start sample processing, the system determines the optimal processing
Processing order using the following criteria, and begins processing the samples with the highest
Order priority first.

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

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.

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4.1: Sample Processing Access 2 Operator’s Guide

LIS Request When the system receives an LIS test request, it uses a set of rules to determine which
Container instrument and sample container it will assign the request to. If a test request is not
Assignment 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 The system searches the test list for test requests for the
instrument 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

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Access 2 Operator’s Guide 4.1: Sample Processing

If the rack is... Then...

On board, and the The system assigns downloaded test requests to the
instrument is in the appropriate sample containers and automatically
Running mode schedules them to run on the instrument.
On board, but the Downloaded test requests remain in the LIS workpool
instrument is not in the until you either:
Running mode
• Select Run, or
• Get the rack and select Done F1 (reload it)
When you select Run, the rules for the Running mode
apply.

Table 4-3 Rules for One Sample Container or Instrument (continued)

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:

If... And... Then...

All sample containers are off board The test remains in the LIS workpool
all instruments in the workgroup 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 Every other sample The test remains in the LIS workpool
an instrument that is not in the container is off board all until you:
Running mode instruments in the • Select Run, or
workgroup
• 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

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4.1: Sample Processing Access 2 Operator’s Guide

If... And... Then...

One sample container is on board The test is enabled on all The system assigns the test requests to
an instrument that is in the instruments the instrument that is in the Running
Running mode and all other mode.
sample containers are on board
instruments that are not in the
Running mode

All sample containers are on board The test is enabled on all The system assigns the test requests to
instruments that are in the Running instruments the instrument that searches the LIS
mode workpool or queries the LIS first.

Table 4-4 Rules for Multiple Sample Containers or Instruments (continued)

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Access 2 Operator’s Guide 4.2: Supply and Calibration Conditions

4.2
Supply 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.

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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.

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Access 2 Operator’s Guide 4.2: Supply and Calibration Conditions

Supplies Required Screen


The Supplies Required screen lists any supplies or calibrations required to complete
the requested tests. You use this screen to:

• Load reagent packs and RVs Supplies


Required Button
• 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 0578A.bmp

continue processing

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

0692A.bmp
Figure 4-5 Supplies Required Screen

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

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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.
Load Reagent Pack (Button) Select to load a reagent pack onto the instrument. For information about
F1 loading reagent packs, see Chapter 2: Supplies.

Table 4-6 Supplies Required Screen Descriptions (continued)

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Access 2 Operator’s Guide 4.2: Supply and Calibration Conditions

Reagent Inventory (Button) Select to display the Reagent Inventory screen to see a list of on-board
F2 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 (Button) Select to change the substrate bottle. You cannot change the substrate
F5 bottle when the system is in the Running mode.
For information about changing the substrate bottle, see Chapter 2: Supplies.
Change RV Waste (Button) Select to change the RV waste bag. For information about changing the
Bag F6 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)

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4.2: Supply and Calibration Conditions Access 2 Operator’s Guide

Requesting Before starting sample processing, you can display the Supplies Required screen to
Verification of get detailed information about any supply and calibration conditions that will prevent
Supplies and the processing of new tests.
Calibrations
Use this procedure to verify supplies and calibrations.

1 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.

2 Correct or override supply or calibration conditions as necessary.

3 Continue sample processing.

For information about overriding conditions, see the Overriding Supply Conditions
procedure in this section.

Overriding You can start sample processing using expired calibrations, substrate, reagent packs,
Supply or reagent lots by overriding the current conditions. The system applies appropriate
Conditions 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.

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

 (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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Access 2 Operator’s Guide 4.2: Supply and Calibration Conditions

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.

2 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 Use this procedure to print a list of supplies required.


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

2 Select Print F7.


The system prints the Supplies Required Report (see Figure 4-7).

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4.2: Supply and Calibration Conditions Access 2 Operator’s Guide

Laboratories, Inc.
Laboratory A
123 Lake Street
Supplies Required Report Townsville, ST 33333
Access 2 Immunoassay System 101-555-2323 ext. 109
S/N 500135 Jane Smith

Tests Requested 36
Tests to Run 0

Required Supply Lot Number Status


Change Substrate 103187 Expired
Change RV Waste Bag
Empty Liquid Waste
1 Cartridge RVs
Change PSA-Hyb 008141 Pack Expired
Recalibrate PSA-Hyb 008141 Calibration Expired

Page 1 of 1
Technologist ________________________ Printed 04/04/11 03:16 PM

0823D.bmp
Figure 4-7 Supplies Required Report

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Access 2 Operator’s Guide 4.3: Work Pending

4.3
Work 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.

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4.3: Work Pending Access 2 Operator’s Guide

Work Pending Screen


You use the Work Pending screen to:

• View a list of off-board samples that have pending test Work Pending
requests Button

• Display the Sample Manager screen, where you can load


the required samples and continue processing
• Delete pending test requests
0580A.bmp
• Print the Work Pending Report

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

Filter (Field) Displays the filter and sort order currently in effect.

Table 4-9 Work Pending Screen Descriptions

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Access 2 Operator’s Guide 4.3: Work Pending

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 (Column) Displays the origin of the test request. Values are: Reflex, LIS, Manual
(Rack/Instrument) 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)

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4.3: Work Pending Access 2 Operator’s Guide

Applying a A work pending filter is a set of parameters you can change to reduce or expand the
Filter to Work number of samples displayed on the Work Pending screen.
Pending
Use this procedure to apply a different filter to the Work Pending screen.

1 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

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

2 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.

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Access 2 Operator’s Guide 4.3: Work Pending

 (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.

3 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 Use this procedure to delete selected tests or all tests from the Work Pending screen.
Pending Tests
1 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.

2 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.

3 Select OK F1.
A confirmation window is displayed.

4 Select Yes F1.


The system deletes the test(s).

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4.3: Work Pending Access 2 Operator’s Guide

Printing Work Use this procedure to print a list of samples associated with pending test requests.
Pending 1 Go to the Work Pending screen. To get to this screen from any screen, select the
Work Pending button.
2 Select Print F7.
The system prints the Work Pending Report (see Figure 4-12).

Laboratories, Inc.
Laboratory A
123 Lake Street
Work 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: 3
LIS 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 1
Technologist ______________________________________ Printed 10/10/11 11:05 PM

0824D.bmp
Figure 4-12 Work Pending Report

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Access 2 Operator’s Guide 4.4: Monitoring Sample Progress

4.4
Monitoring 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.

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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

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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.

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 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.

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

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4.4: Monitoring Sample Progress Access 2 Operator’s Guide

Test Status Definition

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.

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

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Access 2 Operator’s Guide 5: Test Results

5
Test 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

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5: Test Results Access 2 Operator’s Guide

5.1
Test 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:

• 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

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:

• Configure the Test Results screen • Find a specific result


• View sample demographic data and • Rerun tests with flagged results
flags (details)
• Apply a filter to test results • Send results to an LIS
• Delete test results • Copy test results to a disk or USB
flash drive

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.

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Access 2 Operator’s Guide 5.1: Test Results

For more information about setting up and


Set up and run
running calibrators, see Chapter 6: Calibration
calibrators
Data in the Operator's Manual.

For more information about setting up and


Set up and run quality
running quality controls, see Chapter 7: Quality
controls
Controls in the Operator's Manual.

For more information about setting up tests, see


Prepare samples for
Chapter 4: Sample Processing in the Operator's
processing
Manual.

For more information about running a test, see


Run tests Chapter 4: Sample Processing in the Operator's
Manual.

For more information about viewing test results,


View test results see Chapter 5: Test Results in the Operator's
Manual.

0591B.wmf
Figure 5-1 Test Results Flowchart

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5.1: Test Results Access 2 Operator’s Guide

Test Results Screen


You 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

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Access 2 Operator’s Guide 5.1: Test Results

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

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5.1: Test Results Access 2 Operator’s Guide

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)

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Access 2 Operator’s Guide 5.1: Test Results

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)

Selecting Test Use this procedure to select one or more test results on the Test Results screen.
Results
1 Go to the Test Results screen. To get to this screen from the Main Menu, select
Test Results F2.

2 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.

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 (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.

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Access 2 Operator’s Guide 5.2: Reviewing Test Results

5.2
Reviewing 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 A test result filter is a set of parameters you can manipulate to limit the number of
Filters 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.

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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.

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Access 2 Operator’s Guide 5.2: Reviewing Test Results

Main Menu

Test Results
F2

Test Results

Filter
F1

Filter

Select filter
and sort orders

OK
F1

0522A.wmf
Figure 5-4 Applying a Test Result Filter Flowchart

Applying a Use this procedure to apply one of the available test result filters. The following test
Test Result result filters are system-defined:
Filter
Filter Default 1st Order Default 2nd Order

All Flagged Test Results (Last Sample ID Test Name


30 Days)
All Patient Samples (Last 30 Sample ID Test Name
Days)
All Patient Samples Loaded Completion Time
Between...
All Samples (Last 30 Days) Sample ID Test Name
All Samples Loaded Completion Time
Between...

Table 5-5 Filters and Default Sort Orders

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5.2: Reviewing Test Results Access 2 Operator’s Guide

Filter Default 1st Order Default 2nd Order

Failed Auto-Verify and Not Sample ID Test Name


Sent to LIS
LIS Transmission Failed Sample ID Test Name
On-board Patient Samples Sample ID Test Name
On-board Samples Sample ID Test Name
On-board STAT Samples Sample ID Test Name

Table 5-5 Filters and Default Sort Orders (continued)

1 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

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

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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)

2 Select a filter from the list.


The system displays a description of the filter in the Description field.

 (Optional) To change the sort order, select a 1st and 2nd Sort Order option.

 (Optional) To display the results in descending order, clear the Ascending box.

3 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.

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Main Menu

Test Results
F2

Test Results

Filter
F1

Filter

Select filter
and sort orders
Filter Parameters
Edit Filter
F3 Filter Name
Description
Ask for Date & Time
Edit Filter Instruments
Test Result Status
LIS State
Sample ID
Edit filter parameters
Test Name
Auto-Verify
Rack ID
Patient ID
Result
Population
Filter
Clear Parameters
F3
No parameters
OK?

Yes

OK
F1

No Cancel
F4
No Save Filter? No F8

System applies filter, Yes System does not apply


but does not save it or save the filter
Yes
F1

Give the filter a name

OK
F1

0647B.wmf
Figure 5-8 Editing a Test Result Filter Flowchart

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Editing a Test Use this procedure to edit an existing filter and apply it to the Test Results screen.
Result Filter
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.

1 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.

2 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.

3 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

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

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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 (Button) Select to clear all of the fields and reset the parameters to the current filter
F3 parameters.

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

4 Enter the information and select or clear boxes and options to define the
parameters for the filter.

5 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.

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Main Menu

Test Results
F2

Test Results

Filter
F1

Filter

New Filter Filter Parameters


F2
Filter Name
Description
Ask for Date & Time
New Filter
Instruments
LIS State
Test Result Status
Enter filter parameters Sample ID
Test Name
Auto-Verify
Rack ID
Patient ID
Result
New filter Population
Clear Parameters
F3
No parameters
OK?

Yes

OK
F1

No
F4
No Save Filter?

System applies filter, Yes


but does not save it
Yes
F1

Give the filter a name

OK
F1

0610B.wmf
Figure 5-11 Defining a New Test Result Filter Flowchart

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Defining a Use this procedure to define a new filter and apply it to the Test Results screen.
New Test
1 Go to the New Filter window. To get to this window from the Main Menu,
Result Filter
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.

2 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.

3 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.

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Deleting a Use this procedure to delete any new or edited filters. You cannot delete
Test Result system-defined filters.
Filter
1 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.

2 In the Filter list, select the filter you want to delete.

3 Select Delete Filter F4. This button is unavailable for system-defined filters.
The system displays a confirmation message.

4 Select OK F1 to delete the filter.

5 Select Cancel F8 to exit the Filter window without changing the applied filter.

Specifying a Use this procedure to specify date and time parameters when applying a test result
Date and filter that asks for date and time ranges.
Time Range
1 Go to the Filter window. To get to this window from the Main Menu, select
for a Test
Test Results F2 to display the Test Results screen, then select Filter F1.
Result Filter
2 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).

3 Select OK F1. The Specify a Date Range window is displayed.

0927B.bmp
Figure 5-12 Specify a Date Range (Test Results Filter) Window

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Date and Time (Options and field) Select one of the following options to
Range 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 (Option and fields) Select the Date and Time Range option
and Time and specify the starting and ending dates and times.
Range

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

4 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.

5 Select OK F1 to apply the filter.

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Main Menu

Test Results
F2

Find
F2

Find

Enter one of the


following: Sample ID,
Patient ID, Rack ID, or
Test Name

(Optional)
Select a search
direction, up or down

Find Next
F1

Result(s)
selected? No

Yes

Cancel
F8

0520B.wmf
Figure 5-14 Finding a Test Result Flowchart

Finding a Test Use this procedure to search filtered results for a specific test result.
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.

1 Go to the Test Results screen. To get to this screen from the Main Menu, select
Test Results F2.

2 Select Find F2.


The Find window is displayed.

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0609A.bmp
Figure 5-15 Find (Test Result) Window

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

3 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.

4 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.

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 (Optional) To find the next result that fits the search criteria, select
Find Next F1.

5 Select Cancel F8 to exit the window.

Rerunning a Use this procedure to rerun a test. If the sample is on board an instrument, the system
Test 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.

1 Go to the Test Results screen. To get to this screen from the Main Menu, select
Test Results F2.

 (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.

2 Select the test you want to rerun.

3 Select Rerun Test F3.


The system displays a warning message.

4 Select OK F1 to complete the request and exit the window.

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Access 2 Operator’s Guide 5.2: Reviewing Test Results

Main Menu

Test Results
F2

(Optional) To find a For more information about finding test results,


specific test result, see the Finding a Test Result procedure in this
select Find F2. section.

Select a single
test result

Sample Details
F4

Details

Review sample
demographic
information and flag
explanations (if any)

OK
F1

0643B.wmf
Figure 5-17 Viewing Sample Details Flowchart

Viewing Use this procedure to view details about the sample the result is associated with,
Sample including demographic information, comments, and result flag explanations (if
Details applicable).

1 Go to the Test Results screen. To get to this screen from the Main Menu, select
Test Results F2.

 (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.

2 Select a single test result.

3 Select Sample Details F4 to display the Sample Details window.

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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

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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 Select OK F1.

Test Result If something occurs while a test is running or if the system needs supplies, the system
Flags 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.

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5.2: Reviewing Test Results Access 2 Operator’s Guide

Main Menu

Test Results
F2

Test Results

More Options
F8
Configure Screen
F2

Configure Screen

Select optional columns


and column order
for display

OK
F1

0611B.wmf
Figure 5-20 Configuring the Test Results Screen Flowchart

Configuring Use this procedure to change the columns and rearrange the order of the columns
the Test displayed on the Test Results screen. The system displays the following default
Results Screen columns for all filters except for the Failed Auto-Verify and Not Sent to LIS filter:

• Patient ID • Result
• Sample ID • Completion Time
• Rack • Flags
• Test Name • LIS

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.

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1 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.

Column Order
Buttons

0602A.bmp
Figure 5-21 Configure Screen (Test Results) Window

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) Select the right or left arrow button to rearrange the columns in the
Buttons 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

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2 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.

3 Select OK F1.
The Test Results screen displays the new options you selected.

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Access 2 Operator’s Guide 5.3: Managing Test Results

5.3
Managing 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.

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Main Menu

Test Results
F2

Test Results

Filter

Apply filter
and sort orders

Selected
results Filter
No F1
displayed?

Yes

(Optional)
Select a group of
results or a single result

Send to LIS
F5

Send to LIS

Select Current Result,


Current Selection,
Resend LIS Fail, or
All (filtered results)

OK
F1

0644A.wmf
Figure 5-23 Sending Test Results to the LIS Flowchart

Sending Test Use this procedure to manually send test results to the LIS if one or more of the
Results to the following circumstances applies:
LIS • The Auto Send to LIS option is set to Off or to Send Only Auto-Verified
Results. For more information 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.

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1 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 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.

2 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.

3 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 (Option) Select to send the one or more selected test results to
Selection the LIS.
Resend LIS (Option) Select to resend all of the test results with an LIS
Fail status of Fail to the LIS.
All (filtered (Option) Select to send all the test results in the current filter to
results) the LIS.

Table 5-25 Send to LIS Window Descriptions

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4 Select an option from the Send what list (based on your selection in step 2).

5 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.

6 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.

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Main Menu

Test Results
F2

Test Results

Filter

Apply filter
and sort orders

Correct set
Filter
of results No F1
selected?

Yes

Insert a 3.5" disk into


the disk drive or a
USB flash drive into the
USB port

(Optional) For more information about selecting test results,


Select a group of see the Selecting Test Results procedure in
results or a single result Section 5.1.

Copy to Disk
F6

Copy to Disk

• Confirm or change
the file name
• Select a Copy What
option

For USB flash drives,


For 3.5-inch
disks?
No select a drive from the
Drive list

Yes

(Optional)
Select Format disk

OK
F1

0645C.wmf
Figure 5-26 Copying Test Results to a Disk or USB Flash Drive Flowchart

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Copying Test Use this procedure to copy test results to a 3.5-inch high-density, DOS-formatted disk
Results to Disk or a USB flash drive.
or 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.

The Access 2 system writes the following data into a comma-separated field format
that you can import into a PC-based spreadsheet program:

• 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

NOTE
Copying test result data does not remove it from the database.

1 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.

2 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.

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3 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.

4 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

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5.3: Managing Test Results Access 2 Operator’s Guide

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

All (filtered (Option) Select to copy all the test results in the current filter.
results)

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 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.

6 Select an option from the Copy what list.

 (Optional) If the 3.5-inch disk is not formatted, select the Format disk box.

7 Select OK F1. A progress window is displayed.


• To stop the copy process at any time, select Cancel F8.

8 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.

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• For a USB flash drive, clear sufficient space on the drive, or copy the files to
a different flash drive.

9 When the copy process is complete, the system displays a status message.

10 Remove the disk or flash drive from the PC and label it.

NOTE
If you will be using one disk or flash drive to copy multiple files, you can leave
it in place for the next copy operation. Be sure to keep track of the file names so
you can correctly label the disk or flash drive when you remove it.

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5.3: Managing Test Results Access 2 Operator’s Guide

Main Menu

Test Results
F2

Test Results

Find Filter

Enter one of the four Apply a filter


options and sort order

Find Correct results Filter


F2
No No F1
displayed?

Yes
More Options
F8
Delete Data
F3

Password

Enter your
password

OK
F1

Delete Data

Select option from


Delete What list

OK
F1

0646B.wmf
Figure 5-29 Deleting a Test Result Flowchart

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Access 2 Operator’s Guide 5.3: Managing Test Results

Deleting a Use this procedure to permanently delete test results from the database. You need the
Test Result system password in order to delete test results.

CAUTION
Deleting test results removes the data permanently from the database.

1 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.

2 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.

3 Select More Options F8, then select Delete Data F3.


The Password window is displayed.

4 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.

5 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.

6 Select OK F1.
The system displays a warning message.

7 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.

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5.4: Test Result Reports Access 2 Operator’s Guide

5.4
Test 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 Select to print all selected test results.
Report
This report mirrors the configuration of the Test
Results screen.

Table 5-30 Types of Test Result Reports

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Access 2 Operator’s Guide 5.4: Test Result Reports

Report Description

Continuous Sample To print this report, set up the automatic print option.
Report 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.

Table 5-30 Types of Test Result Reports (continued)

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.

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5.4: Test Result Reports Access 2 Operator’s Guide

Main Menu

Test Results
F2

Test Results

System Configuration
Is For information about how to
Are you
printing from
Continuous automatically print test result
Set up the Auto Print
a completed
No Sample Report No reports, see Chapter 4: System
option
set to Configuration in the Reference
Filter run?
print? Manual.

Apply filter Yes


Yes
and sort orders
Print
F7
Is correct
Filter
No sample(s)
F1 Completed Samples
displayed?
F2

Yes

(Optional)
Select a group of
displayed results

Print
F7

Report
F1

Print

1. Select a report from the Reports field


2. Select an option from the Print What list

OK
F1

0519C.wmf
Figure 5-31 Printing Test Result Reports Flowchart

Printing Test Use this procedure to print a test result report.


Result Reports
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.

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Access 2 Operator’s Guide 5.4: Test Result Reports

• 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.

1 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.

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.

3 Select Print F7.

4 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

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5.4: Test Result Reports Access 2 Operator’s Guide

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

Report (List) Select a report to print.


Current Result (Option) Select to print a report for the selected test result.
Current (Option) Select to print reports for one or more selected test
Selection results.
All (filtered (Option) Select to print all the test results in the current filter.
results)

Table 5-33 Print (Test Result Reports) Descriptions

5 Select the type of report you want to print from the report list (see Table 5-30).

6 Select the appropriate option from the Print What list (based on your selection
in step 2).

7 Select OK F1.
The system sends the report to the printer. A progress window is displayed.
Select Cancel F8 to stop the print job at any time.

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Access 2 Operator’s Guide 5.4: Test Result Reports

Laboratories, Inc.
Laboratory A
123 Lake Street
Townsville, ST 33333
Patient Report 101-555-2323 ext. 109
Access 2 Immunoassay System R. Goldman

Patient ID: 555-56-9898


Name: Feldmann, A.
Sex: Male
Birth Date: 10-15-1944

**STAT**
Sample ID: 23345128Dil Sample Type: Plasma Dilution: 10
Test Name Result Ref. Range Flags Completed
CK-MB 939.0 ng/mL 0.000 - 4.000 10-10-10 08:18 PM
Comments: Sample slightly cloudy.

**STAT**
Sample ID: 23345128 Sample Type: Plasma
Test Name Result Ref. Range Flags Completed
CK-MB >293 ng/mL 0.000 - 4.000 OVR 10-10-10 07:30 PM
MYO(2) No Value 17.400-105.700 QNS 10-10-10 07:27 PM
MYO 60.04 ng/mL 17.400-105.700 10-10-10 07:27 PM

Sample ID: 423005160 Sample Type: Serum


Test Name Result Ref. Range Flags Completed
FreePSA% 16.6 10-08-10 02:45 PM
freePSA 1.58 ng/mL 10-08-10 02:45 PM
PSA-Hyb 9.53 ng/mL 0.000 - 4.000 10-08-10 02:15 PM
Comments: Copy of results to Dr Bennett.

Sample ID: 423000204 Sample Type: Serum


Test Name Result Ref. Range Flags Completed
PSA-Hyb(2) 3.71 ng/mL 0.000 - 4.000 10-02-10 12:03 PM
PSA-Hyb 3.86 ng/mL 0.000 - 4.000 10-02-10 11:15 AM

OVR = Over range QNS = Insufficient Sample


Page 1 of 1
Technologist ____________________________________ Printed 10-10-10 10:25 PM

0660E.bmp
Figure 5-34 Patient Report

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5.4: Test Result Reports Access 2 Operator’s Guide

Laboratories, Inc.
Laboratory A
123 Lake Street
Townsville, ST 33333
Sample Report 101-555-2323 ext. 109
Access 2 Immunoassay System B. Beaulieu

Sample ID: 23345128 Sample Type: Serum


Patient ID: 555-56-9898
Name: Follett F.
Sex: Male
Birth date: 10-15-1944

**STAT**
Instrument: 501240
Test Name Result Ref. Range Flags Dilution Completed
CK-MB >293 ng/mL 0.000 - 4.000 OVR 1 10-10-10 07:30 PM
MYO(2) No Value 17.400-105.700 QNS 1 10-10-10 07:27 PM
MYO 60.04 ng/mL 17.400-105.700 1 10-10-10 07:16 PM

Instrument: 500135
Test Name Result Ref. Range Flags Dilution Completed
FreePSA% 16.6 1 10-08-10 02:45 PM
freePSA 1.58 ng/mL 1 10-08-10 02:45 PM
PSA-Hyb 9.53 ng/mL 0.000 - 4.000 1 10-08-10 02:15 PM
Comments: Cloudy sample.

OVR = Over range QNS = Insufficient Sample


Page 1 of 1
Technologist _____________________________________ Printed 10-10-10 10:28 PM

0748E.bmp
Figure 5-35 Sample Report

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Access 2 Operator’s Guide 5.4: Test Result Reports

Laboratories, Inc.
Laboratory A
123 Lake Street
Selected Test Results Report Townsville, ST 33333
Access 2 Immunoassay System 101-555-2323 ext 109
S/N 501240 V. Flores

Filter: All Samples - Sorted by Sample ID Then by Test Name

Sample ID Rack Test Name Result Flags LIS Comp. Time


13501350 48 Ferritin 404.1 ng/mL Accepted 10/10/10 06:40
13501350 48 FOL2 4.34 ng/mL Accepted 10/10/10 06:32
13501350 48 VitB12 354 pg/mL Accepted 10/10/10 06:38
19953581 504 freePSA Supply Wait
19953581 504 PSA-Hyb Supply Wait
23345128 106 CK-MB >293 ng/mL OVR Accepted 10/10/10 19:30
23345128 106 MYO 60.04 ng/mL Accepted 10/10/10 19:27
23345128 106 MYO(2) No Value QNS Accepted 10/10/10 19:27
25688888 48 VitB12 103 pg/mL Failed 10/10/10 06:41
78910116 502 FOL2 Cancelled SYS 10/10/10 10:46

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


Page 1 of 1
Technologist ________________________________ Printed 10/10/10 20:07

0749D.bmp
Figure 5-36 Selected Test Results Report

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Laboratories Inc.

5-50
Laboratory A
123 Lake Street
Continuous Sample Report Townsville, ST 33333
Access 2 Immunoassay System 101-555-2323 ext. 109
S/N 501240 Jane Smith
___________________________________________________________________________________________________________________________________
5.4: Test Result Reports

Rack/Pos Sample ID Type Test Result Ref. Range Flags RLUs Completion
Patient/Lot ID Dilution
___________________________________________________________________________________________________________________________________
122/1 23345128 Plasma
**STAT** 555-56-9898 1 CK-MB >293 ng/mL 0.000 - 4.000 OVR 18445200 10-10-10 06:01 PM
MYO 60.04 ng/mL 17.400-105.700 337183 10-10-10 05:58 PM
MYO(2) No Value 17.400-105.700 QNS No Value 10-10-10 05:48 PM
Dig 853012 RLU NCR 853012 10-10-10 06:07 PM
Comments: This sample comment was entered in the Test Requests screen.
___________________________________________________________________________________________________________________________________
115/1 236-79 Serum
126-00-544 1 PSA-Hyb 14.82 ng/mL 0.000 - 4.000 2606765 10-10-10 06:01 PM
freePSA 12.24 ng/mL 6390525 10-10-10 06:00 PM
FreePSA% 82.6 No Value 10-10-10 06:01 PM
Comments: This sample comment was entered in the Test Requests screen.
___________________________________________________________________________________________________________________________________
115/2 999 Serum
669-52-555 1 VitB12 170 pg/mL 180.000 - 914.000 2138570 10-10-10 06:17 PM
Ferritin 61.5 ng/mL 11.000 - 340.000 678573 10-10-10 06:13 PM
FOL2 4.39 ng/mL 564312 10-10-10 06:17 PM
___________________________________________________________________________________________________________________________________

Figure 5-37 Continuous Sample Report


115/3 2250 Serum
88-954-52396 1 VitB12 354 pg/mL 180.000 - 914.000 1373280 10-10-10 06:19 PM
Ferritin 408.1 ng/mL 11.000 - 340.000 4038840 10-10-10 06:15 PM
FOL2 0.70 ng/mL 2044250 10-10-10 06:19 PM
___________________________________________________________________________________________________________________________________

RFX = Reflexed test; OVR = Over range; QNS = Insufficient sample; NCR = No curve;
Page 1 of 1
Technologist __________________________________________ Printed 10-10-10 06:19 PM

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0661E.bmp
Access 2 Operator’s Guide
Access 2 Operator’s Guide 6: Assay Calibrations

6
Assay 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

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6.1
Assay 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.

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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.

For more detailed information about


Set up calibrators how to set up calibrators, see the Setting Up
Calibrators procedure in this chapter.

For more detailed information about how to


Enter and run a
request a calibration test, see Chapter 3:
calibration request
Sample Management.

Review calibration For more detailed information about how to


cutoffs and curves view calibration data, see the Viewing
Calibration Data procedure in this chapter.

0521A.wmf
Figure 6-1 Calibration Flowchart

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6.1: Assay Calibrations Access 2 Operator’s Guide

Calibration Screen
You 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

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Access 2 Operator’s Guide 6.1: Assay Calibrations

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)

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6.1: Assay Calibrations Access 2 Operator’s Guide

Applying a Use this procedure to apply a filter to the calibration buttons on the Calibration screen.
Calibration You can choose a filter and specify the direction of the sort order.
Filter
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.

1 Go to the Calibration screen. To get to this screen from the Main Menu, select
Calibration F5.

2 Select Filter F1.


The Filter window is displayed.

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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Access 2 Operator’s Guide 6.1: Assay Calibrations

3 Select one of the filter options.

4 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.

5 Select OK F1.
The system applies the filter and displays the results on the Calibration screen.

Deleting Use this procedure to delete the stored data for an assay calibration and reagent lot.
Calibrations 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.

1 Go to the Calibration screen. To get to this screen from the Main Menu, select
Calibration F5.

2 Select the button for the assay calibration and reagent lot you want to delete.

3 Select Delete F6.


The system displays a confirmation message.

4 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

6.2
Reviewing 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.

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Stored For calibrations with a cutoff, the system stores calibration data for the active and last
Calibration run calibrations. For calibrations that produce a curve, the system stores calibration
Data 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 The calibration that was previously the active calibration. You
Active 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

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6.2: Reviewing Calibration Data Access 2 Operator’s Guide

Calibration Data Screens


You 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)

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Access 2 Operator’s Guide 6.2: Reviewing Calibration Data

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) (Field) Displays the date and time that the calibration was run.
or
Calibrated (Curve)

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

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6.2: Reviewing Calibration Data Access 2 Operator’s Guide

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)

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Data Table • %CV: The percent coefficient of variation for the calibrator replicates.
(continued)
• 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 (Table) Displays information about the upper and lower cutoff configured for this
(RLUs) (Cutoff only) 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 (Chart) Displays the curve generated from the calculated RLU means for this
Curve (Linear) calibration. You can use the left and right arrow keys (under the chart) to scroll and
(Curve only) 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.

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

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6.2: Reviewing Calibration Data Access 2 Operator’s Guide

Select Curve F1 (Button) Select to display a menu of these stored calibrations:


Active F1
Displays the active calibration for the assay.
Previous Active F2 (Curve only)
Displays the previous active calibration for the assay.
Last Run F3
Displays 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 (Button) Select to switch the active calibration for the assay with the previous
F2 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.

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

Calibration When a calibration fails, the system displays a failure code in the Status field on the
Failure Codes Calibration Data screens. The failure codes below are for either cutoffs or curves.

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

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Access 2 Operator’s Guide 6.2: Reviewing Calibration Data

Failure Code Description

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.

Table 6-10 Calibration Failure Codes (continued)

Viewing Use this procedure to view the calibration curve or cutoff, along with detailed
Calibration calibration data.
Curves and
1 Go to the Calibration screen. To get to this screen from the Main Menu, select
Cutoffs
Calibration F5.

2 Select the button for the assay calibration and reagent lot you want to view.

3 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.

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6.2: Reviewing Calibration Data Access 2 Operator’s Guide

Switching the Use this procedure to switch the active calibration with the previous active
Active with calibration. This procedure is for quantitative assays only.
the Previous
Active NOTES
Calibration • 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.

1 Go to the Calibration screen. To get to this screen from the Main Menu, select
Calibration F5.

2 Select the button for the assay calibration you want to switch.

3 Select Review Data F2.


The Calibration Data screen is displayed.

4 Select Switch Active Curve F2.


A confirmation message is displayed.

5 Select OK F1.
The active and previous active calibration curves are switched. The previous
active calibration curve is displayed.

Adding a Use this procedure to enter, edit, or view a calibration comment.


Calibration
1 Go to the Calibration screen. To get to this screen from the Main Menu, select
Comment
Calibration F5.

2 Select a calibration button.

3 Select Review Data F2.


The Calibration Data screen is displayed.

4 Select Comment F3.


The Calibration Comment window is displayed.

5 Type a comment for the calibration.

6 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

6.3
Calibration 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 This report is printed from the
(Cutoff) 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 This report is printed from the
(Curve) 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

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6.3: Calibration Reports Access 2 Operator’s Guide

Printing a Use this procedure to print the Calibration Report or a Calibration Data Report.
Calibration
1 Go to the Calibration Screen. To get to this screen from the Main Menu, select
Report
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.

2 Select Print F7.


A print message is displayed.

3 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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Access 2 Operator’s Guide 6.3: Calibration Reports

Laboratories, Inc.
Laboratory A
123 Lake Street
Calibration Report Townsville, ST 33333
Access 2 Immunoassay System 101-555-2323 ext. 109
S/N 502338 Jane Smith

Filter: All Calibrations - Ascending Sorted by Test Name and Reagent Lot

Test Name Reagent Lot


AFP 029940
aTnI 620004
aTnI 620005
CK-MB 093060
CK-MB 113021
EPO 094973
FastTSH 117785
FRT4 614500
FRT4 614501
IgG-Toxo 050088
IgG-Toxo 080071
MYO 053755
Rub-IgG 060211
Rub-IgG 120283
TBhCG2 131654
TSH 074523
TSH 117785
TotT3 002698

Page 1 of 1
Technologist_________________________________________ Printed 04/04/07 12:43 PM

0790D.bmp
Figure 6-12 Calibration Report

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6.3: Calibration Reports Access 2 Operator’s Guide

Laboratories, Inc.
Laboratory A
123 Lake Street
Calibration Data Report Townsville, ST 33333
Access 2 Immunoassay System 101-555-2323 ext. 109
S/N 414141 Jane Smith

Test Name: IgM-Toxo Curve: Last Run: Active


Reagent Lot: 100112 Status: Passed
Established 09/23/11 02:29 PM Reason: (if status is Failed, reason prints here)
Expiration: 10/21/11 02:29 PM Cal Lot: 112001
Cutoff: 360000 Units S/CO
Comment:

Stated Conc. RLU 1 SD %CV Result Flags


C0 Non-Reactive 50000 Non-Reactive Cal
C0 Non-Reactive 50000 Non-Reactive Cal
Mean 50000.00 0.00 0.00
C1 Reactive 900000 Reactive Cal
C1 Reactive 900000 Reactive Cal
Mean 900000.50 0.00 0.00

Acceptance Limits (RLUs)

Replicate Mean

Level Low High Low High

C0 10000 90000 10000 90000

C1 140000 1600000 140000 1600000

Page 1 of 1
Technologist __________________________________________ Printed 09/23/11 03:19 PM

0907C.bmp
Figure 6-13 Calibration Data Report (Cutoff)

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Access 2 Operator’s Guide 6.3: Calibration Reports

Laboratories, Inc.
Laboratory A
123 Lake Street
Calibration Data Report Townsville, ST 33333
Access 2 Immunoassay System 101-555-2323 ext. 109
S/N 500135 Jane Smith
____________________________________________________________________________________________________
Test Name: PSA-Hyb Curve: Active
Reagent Lot: 005711 Status: Passed
Calibrated: 01/22/01 12:34 PM Reason: (if Status is Failed, reason prints here)
Expiration: 02/19/01 12:34 PM Cal Lot: 006541
Comment:

Stated Conc. ng/mL RLU 1SD % CV Calculated Conc. ng/mL Flags


S0 0.00 14804 No Value
S0 0.00 14927 0.00
Mean 14865.35 86.76 0.58 0.00
S1 0.48 93587 0.48
S1 0.48 94176 0.48
Mean 93881.30 416.06 0.44 0.48
S2 2.04 349705 2.06
S2 2.04 343755 2.02
Mean 346730.00 4207.29 1.21 2.04
S3 10.10 1594880 10.03
S3 10.10 1626570 10.24
Mean 1610725.00 22408.21 1.39 10.14
S4 74.70 9777480 75.98
S4 74.70 9492180 73.20
Mean 9634830.00 201737.56 2.09 74.59
S5 145.00 15770900 145.85
S5 145.00 15788900 146.10
Mean 15779900.00 12727.92 0.08 145.98

Page 1 of 1
Technologist ______________________________________________ Printed 02-02-01 11:05 AM

0791C.bmp
Figure 6-14 Calibration Data Report (Curve)

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6.4: Setting Up Calibrators Access 2 Operator’s Guide

6.4
Setting 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.

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Access 2 Operator’s Guide 6.4: Setting Up Calibrators

Calibrator Setup Screen


You 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

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6.4: Setting Up Calibrators Access 2 Operator’s Guide

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

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Access 2 Operator’s Guide 6.4: Setting Up Calibrators

Main Menu

Calibration
F5

Calibration

Calibrator Setup
F5

Calibrator Setup

Add Calibrator
F1

Add Calibrator

Scan the calibrator


bar code or type the
coded information
under the bar code

Calibrator
information No
correct?

Yes

OK
F1

0528A.wmf
Figure 6-17 Adding a Calibrator Flowchart

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6.4: Setting Up Calibrators Access 2 Operator’s Guide

Adding a Use this procedure to add a calibrator to the system.


Calibrator
1 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.

2 Select Add Calibrator F1.


The Add Calibrator window is displayed.

0765B.bmp
Figure 6-18 Add Calibrator Window

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

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Stated (Column) Displays the stated concentration of each calibrator level.


Concentration
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)

3 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.

4 Verify the information you entered is correct and select OK F1.


The system adds the calibrator to the system.

Editing a Use this procedure to edit the bar code ID of an existing calibrator.
Calibrator
1 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.

2 Select the calibrator to be edited.

3 Select Edit a Calibrator F2.


The Edit Calibrator window is displayed (identical to the Add Calibrator
window).

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6.4: Setting Up Calibrators Access 2 Operator’s Guide

4 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.

5 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 Use this procedure to delete a calibrator from the system.


Calibrator
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.

1 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.

2 Select a calibrator to delete from the system.

3 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.

4 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

7
Quality 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

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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

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Access 2 Operator’s Guide 7.1: Quality Controls

7.1
Quality 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.

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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.

For more detailed information


about how to set up quality
Set up Quality Controls
controls, see Setting up Quality
Controls in this chapter

For more detailed information


about how to run QC tests, see
Run QC tests
Chapter 3 Sample Management in
the Operator's Guide

Review QC

For more detailed For more detailed


information about how to information about how
view QC charts and data, Review QC charts to compare QC charts,
Compare charts
see the Viewing QC and data see the Comparing
Charts and Data QC Charts procedure
procedure in this chapter in this chapter

0750B-version1.1.wmf
Figure 7-1 Quality Controls Flowchart

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Access 2 Operator’s Guide 7.1: Quality Controls

Quality Control Screen


You use the Quality Control screen to:

• Review Levey-Jennings charts and data Quality Control


Button
• Compare Levey-Jennings charts of two or three quality
controls
• Delete Levey-Jennings chart comparisons
• Set up quality controls 0581A.bmp

• Print reports

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

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

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7.1: Quality Controls Access 2 Operator’s Guide

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 (Button) Select to view the Levey-Jennings chart and QC point data for a specific
Data F2 quality control.
Compare Charts F3 (Button) Select to view the Levey-Jennings charts for two or three quality controls.
Delete Comparison (Button) Select to delete one or more saved comparisons from the Quality Control
F4 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)

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Access 2 Operator’s Guide 7.1: Quality Controls

Applying a A quality control filter is a set of parameters you can change to reduce or expand the
QC Filter 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.

1 Go to the Quality Control screen. To get to this screen from the Main Menu,
select Quality Control F4.

2 Select Filter F1.


The Filter window is displayed.

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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7.1: Quality Controls Access 2 Operator’s Guide

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)

3 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.

4 Select OK F1.
The system displays all quality controls that meet the selected parameters on the
Quality Control screen.

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

1 Go to the Quality Control screen. To get to this screen from the Main Menu,
select Quality Control F4.

2 Select Delete Comparison F4.


The Delete Comparison window is displayed.

3 Select one or more comparisons to delete from the list.


A confirmation window is displayed.

4 Select OK F1.

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Access 2 Operator’s Guide 7.2: Reviewing Quality Control Charts and Data

7.2
Reviewing 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 Westgard QC rules are interpretive rules developed to avoid excessive false rejection
Rules rates, to improve quality monitoring, and to decrease subjectivity of data analysis.

Each laboratory determines the QC rules to apply and the course of action to take
when a result violates a rule. Understand how your laboratory uses QC rules before
you set up controls.

Application of a QC rule consists of screening quality control test results for the
number of standard deviations (SD) above or below the mean, and for the number of
consecutive occurrences. Data points are colored red to mark violations of rules. For

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


Jennings point represents a result and the distance on, above, or below the expected mean result
Charts (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.

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Access 2 Operator’s Guide 7.2: Reviewing Quality Control Charts and Data

QC Chart and Data Screen


You 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

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7.2: Reviewing Quality Control Charts and Data Access 2 Operator’s Guide

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.
For information about defining the decimal places for an assay, see Section 4.4:
Test Setup in the Reference Manual.
%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)

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Access 2 Operator’s Guide 7.2: Reviewing Quality Control Charts and Data

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.

Table 7-7 QC Chart and Data Screen Descriptions (continued)

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7.2: Reviewing Quality Control Charts and Data Access 2 Operator’s Guide

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.

Table 7-7 QC Chart and Data Screen Descriptions (continued)

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Access 2 Operator’s Guide 7.2: Reviewing Quality Control Charts and Data

Viewing Use this procedure to view the quality control data for a selected test. If you want to
Quality view or compare more than one test, see the Comparing QC Charts procedure in this
Control section.
Charts and
1 Go to the Quality Control screen. To get to this screen from the Main Menu,
Data
select Quality Control F4.

2 Select the quality control you want to view.

3 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 A QC chart and data filter controls the amount of data displayed on the QC Chart and
QC Chart and Data screen and printed in reports. The filter limits data according to the following
Data Filter 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.

1 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.

2 Select Filter F1.


The Filter window is displayed.

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7.2: Reviewing Quality Control Charts and Data Access 2 Operator’s Guide

1026A.bmp
Figure 7-8 Filter (QC Chart and Data) Window

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 (Boxes) These boxes are reserved for future use.
Pipettor

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

3 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.

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Access 2 Operator’s Guide 7.2: Reviewing Quality Control Charts and Data

4 Select a single reagent lot to view, or select All to view data for all lots of the
reagent for the selected test.

5 Select OK F1.
The system applies the filter and displays the results on the QC Chart and Data
screen.

Entering Use this procedure to enter, edit, or delete comments for quality control samples on
Quality the QC Chart and Data screen.
Control
1 Go to the Quality Control screen. To get to this screen from the Main Menu,
Comments
select Quality Control F4.

2 Select a quality control for comment.

3 Select Review Chart and Data F2.


The QC Chart and Data screen is displayed.

4 Select the Pen or Notepad button next to the appropriate result to display the
QC Comment window.

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.

5 In the Comment field, enter or edit comments. Or, to delete an existing


comment, select it and press [Backspace].

6 To save comments, select OK F1.

Omitting a Use this procedure to omit a point from the mean, SD, and %CV calculations (QC
QC Data Point calculations). The point remains on the chart, marked as omitted by a diagonal line
through it.

1 Go to the Quality Control screen. To get to this screen from the Main Menu,
select Quality Control F4.

2 Select the quality control that contains the point you want to omit.

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7.2: Reviewing Quality Control Charts and Data Access 2 Operator’s Guide

3 Select Review Chart and Data F2.


The QC Chart and Data screen is displayed.

4 Select a data point to be omitted from the data table.

5 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 Use this procedure to delete a selected point from the screen, reports, and statistical
Point calculations. You must have the correct system password to use this option. An
information event is created in the Event Log.

1 Go to the Quality Control screen. To get to this screen from the Main Menu,
select Quality Control F4.

2 Select the quality control that contains the point you want to delete.

3 Select Review Chart and Data F2.


The QC Chart and Data screen is displayed.

4 Select the point to delete. Touch the point or use the arrow keys in the bottom
corner of the chart to select the point.

5 Select Delete Point F5.


You must enter the correct password. A warning message is displayed.

6 Select OK F1 to delete the point from the system.

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Access 2 Operator’s Guide 7.2: Reviewing Quality Control Charts and Data

Copying QC Use this procedure to copy QC data to a 3.5-inch high density, DOS-formatted disk or
Data to Disk USB flash drive.
or 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.

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.

1 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.

2 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.

3 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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7.2: Reviewing Quality Control Charts and Data Access 2 Operator’s Guide

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.

4 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.

5 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.

6 Select OK F1.
A progress window is displayed.
• To stop the copy process at any time, select Cancel F8.
7 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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Access 2 Operator’s Guide 7.2: Reviewing Quality Control Charts and Data

Compare Charts Screen


You 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

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7.2: Reviewing Quality Control Charts and Data Access 2 Operator’s Guide

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 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.
%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.
Levey-Jennings (Chart) Displays two or three graphs of the plotted points from each quality
Charts 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)

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Access 2 Operator’s Guide 7.2: Reviewing Quality Control Charts and Data

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 (Button) Select to save the comparison. If you save the comparison, the system
F1 creates a comparison button. You can then select the comparison button from the
Quality Control screen to view it.
Review Chart and (Button) Select to display the QC Chart and Data screen for one of the charts. A
Data F2 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)

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7.2: Reviewing Quality Control Charts and Data Access 2 Operator’s Guide

Main Menu

Quality Control
F4

Quality Control

Select two or three quality


controls to compare

Compare Charts
F3

Compare Charts Edit Date Range

Charts with points for the Change the date range


past 31 days are displayed

Edit Date Range


F4

Is correct date
range displayed? No

Yes

Save the
No
comparison?

Yes

Save Comparison
F1

Save Comparison

Enter text to name the


comparison

Continue reviewing or processing data

0779C.wmf
Figure 7-12 Comparing QC Charts Flowchart

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Access 2 Operator’s Guide 7.2: Reviewing Quality Control Charts and Data

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

1 Go to the Quality Control screen. To get to this screen from the Main Menu,
select Quality Control F4.

2 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.

3 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 Use this procedure to save the comparison from the Compare Charts screen.
Comparisons
1 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.

2 Enter text for the comparison button (notes or information about the
comparison) in the Line 1 and Line 2 fields.

3 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

7.3
Quality 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:

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.

Printing a QC Use this procedure to print a QC Review Report (see Figure 7-13).
Review Report
1 Go to the Quality Control screen. To get to this screen from the Main Menu,
select Quality Control F4.

2 Select Print F7.


The system sends the report to the printer.

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Access 2 Operator’s Guide 7.3: Quality Control Reports

Laboratories, Inc.
Laboratory A
123 Lake Street
Townsville, ST 33333
QC Review Report 101-555-2323 ext. 109
Access 2 Immunoassay System Jane Smith

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


Control Name Control Lot Test Name Expiration Instrument Pipettor
LowPos 012461 Chl-Ag 01/01/03 500135 N/A
Cardiac A 1234567A CK-MB 11/11/02 501240 N/A
Cardiac B 1234567B CK-MB 11/11/02 501240 N/A
Cardiac C 1234567C CK-MB 11/11/02 501240 N/A
Cardiac A 1234567A cTnI 11/11/02 500135 N/A
Cardiac A 1234567A cTnI 11/11/02 501240 N/A
Cardiac B 1234567B cTnI 11/11/02 500135 N/A
Cardiac B 1234567B cTnI 11/11/02 501240 N/A
Cardiac C 1234567C cTnI 11/11/02 500135 N/A
Cardiac C 1234567C cTnI 11/11/02 501240 N/A
Cardiac A 1234567A Dig 11/11/02 501240 N/A
Cardiac B 1234567B Dig 11/11/02 501240 N/A
Cardiac C 1234567C Dig 11/11/02 501240 N/A
High Control 98765C freePSA 03/03/03 500135 N/A
Low Control 98765A freePSA 03/03/03 500135 N/A
Cardiac A 1234567A MYO 11/11/02 501240 N/A
Cardiac B 1234567B MYO 11/11/02 501240 N/A
Cardiac C 1234567C MYO 11/11/02 501240 N/A
High Control 98765C PSA-Hyb 03/03/03 500135 N/A
Low Control 98765A PSA-Hyb 03/03/03 500135 N/A

Page 1 of 1
Technologist ____________________________________________ Printed 10/10/02 02:43 PM

0772C.bmp
Figure 7-13 QC Review Report

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7.3: Quality Control Reports Access 2 Operator’s Guide

Printing a QC Use this procedure to print a QC Chart Report, a QC Data Report, or a combination of
Chart or Data both reports.
Report
1 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.

2 Select Print F7.


The Print window is displayed.

0759A.bmp
Figure 7-14 Print (QC Chart and Data) Window

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 (Box) Select to print the entire date range selected in the
Range QC Chart and Data screen. If the date range is more than 31
days, charts continue on additional pages.
Clear to print only the data on the screen. Chart reports are
limited to 31 days, and data reports print only four lines.

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

3 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.

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Access 2 Operator’s Guide 7.3: Quality Control Reports

4 Select OK F1.
The system sends the report to the printer.

Laboratories, Inc.
Laboratory A
123 Lake Street
QC Data Report Townsville, ST 33333
Access 2 Immunoassay System 101 - 555 - 2323 ext. 109
S/N 501240 Jane Smith

Test: TropI Start Date: 10/01/11


Control: CardiacB End Date: 10/07/11
Control Lot: 1234567B Points: 7
Expiration: 11/11/11 Mean: 0.3054
Stated Mean: 0.3000 SD: 0.0370
Stated SD: 0.1000 %CV: 12.12
Des. Pipettor: N/A Units: ng/mL

Value SDI Completion QC Rules Comment Omit Reagent Pipettor


Lot
0.303 ng/mL 0.026 10/01/11 08:39 PM 130161 N/A
0.299 ng/mL -0.015 10/02/11 08:35 PM 130161 N/A
10.418 ng/mL 101.180 10/03/11 08:25 PM *1**3* Contaminated X 130161 N/A
sample- retest
with new sample
0.294 ng/mL -0.062 10/03/11 09:10 PM 130161 N/A
0.247 ng/mL -0.526 10/04/11 08:37 PM 130161 N/A
0.292 ng/mL 0.076 10/05/11 08:52 PM 130161 N/A
0.361 ng/mL 0.610 10/06/11 03:12 PM 144219 N/A
0.588 ng/mL 2.882 10/07/11 04:18 PM *1* Sample left in X 144219 N/A
instrument too
long- 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 1
Technologist _____________________________________________ Printed 10/10/11 05:32 PM

0773E.bmp
Figure 7-16 QC Data Report

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Laboratories, Inc.

7-30
Laboratory A
123 Lake Street
QC Chart Report Townsville, ST 33333
Access 2 Immunoassay System 101-555-2323 ext. 109
S/N 501240 Jane Smith
________________________________________________________________________________________________________________________________
Test: TropI Start Date: 10/01/11
Control: CardiacB End Date: 10/07/11
Control Lot: 1234567B Points: 7
7.3: Quality Control Reports

Expiration: 11/11/11 Mean: 0.3054


Reagent Lot All SD: 0.0370
Stated Mean 0.3000 %CV: 12.12
Stated SD: 0.1000 Units: ng/mL
Des. Pipettor: N/A

0.600 3
0.500 2
0.400 1
0.300 0
0.200 -1
0.100 -2
-0.000 -3
10/02 10/04 10/06

Figure 7-17 QC Chart Report


10/01 10/03 10/05 10/07

Page 1 of 1
Technologist ________________________________________________ Printed 10/10/11 05:32 PM

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Access 2 Operator’s Guide
Access 2 Operator’s Guide 7.4: Setting Up Quality Controls

7.4
Setting 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.

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7.4: Setting Up Quality Controls Access 2 Operator’s Guide

Main Menu

Quality Control
F4

Quality Control

QC Setup
F5

QC Setup

Add Control
F1

Add Control

Enter quality control


and set up QC rules

OK
F1

All control
parameters No
entered?

Yes

Done

0780A.wmf
Figure 7-18 Setting Up Quality Controls Flowchart

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Access 2 Operator’s Guide 7.4: Setting Up Quality Controls

QC Setup Screen
You 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

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7.4: Setting Up Quality Controls Access 2 Operator’s Guide

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

Adding a Use this procedure to define a new quality control and enter the tests, means, SDs, and
Quality QC rules for that quality control.
Control
1 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.

2 Select Add Control F1.


The Add Control window is displayed.

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Access 2 Operator’s Guide 7.4: Setting Up Quality Controls

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 (Column) Displays the value N/A. This column is reserved for future use.
Pipettors

Table 7-22 Add Control Window Descriptions

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7.4: Setting Up Quality Controls Access 2 Operator’s Guide

Clear Row F3 (Button) Select to clear the information from a selected row.
Designate (Button) This button is reserved for future use.
Pipettor F4

Table 7-22 Add Control Window Descriptions (continued)

3 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.

4 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.

5 Record the quality control information on the QC worksheet (see Figure 7-23).
Do this for any quality control you set up.

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Access 2 Operator’s Guide 7.4: Setting Up Quality Controls

Editing a Use this procedure to edit an existing quality control.


Quality
1 Go to the QC Setup screen. To get to this screen from the Main Menu, select
Control
Quality Control F4 to display the Quality Control screen, then select
QC Setup F5.

2 Select a quality control to edit.

3 Select Edit Control F2.


The Edit Control window is displayed. This window is similar to the Add
Control window.

4 To edit the expected mean for a quality control test, enter the new value in the
Mean field.

5 To edit the expected standard deviation for a quality control test, enter the new
value in the SD field.

6 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.

7 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 Use this procedure to delete a quality control.


Quality
Control NOTE
If any of the instruments in your workgroup are in the Running or Paused
mode, the quality control cannot be deleted.

1 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.

2 Select the quality control you want to delete from the QC Setup list.

3 Select Delete Control F6.


A password window is displayed.

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7.4: Setting Up Quality Controls Access 2 Operator’s Guide

4 Enter the correct password.


A confirmation window is displayed.

5 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.

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Access 2 Operator’s Guide 7.5: Establishing QC Ranges

7.5
Establishing 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 Use this procedure, along with your standard laboratory procedure, to establish
Data to quality control ranges.
Establish QC
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)

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7.5: Establishing QC Ranges Access 2 Operator’s Guide

Steps
1 Run 1 or 2 replicates of each quality control one time each day. Vary the
sequence in which the quality control samples are processed.

2 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.

3 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.

4 Calculate the mean, %CV, 1SD, 2SD, and 3SD values, and the 3SD range for
each quality control level/analyte combination.

5 Perform outlier evaluation:


• Remove any values outside of the 3SD range (outliers), then recalculate the
mean, %CV, 1SD, 2SD, and 3SD values. Continue to step 6.
• If no outliers are detected, use the data calculated in step 4 and continue with
step 7.

6 Perform a second outlier evaluation. Remove any values outside of the 3SD
range, then recalculate the mean, %CV, 1SD, 2SD, and 3SD values.

7 Calculate the acceptable 1SD, 2SD, and 3SD 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.

8 Periodically recalculate the values and ranges during the life of the control lot.

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Access 2 Operator’s Guide 7.5: Establishing QC Ranges

Assigning Use this procedure to assign temporary or provisional quality control ranges.
Temporary
1 Run 1 or 2 replicates of each quality control daily.
QC Ranges
2 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.

3 Obtain at least 29 values per quality control level.

4 Calculate the mean for each quality control level/analyte combination.

5 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.

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7.6: Quality Control Worksheet Access 2 Operator’s Guide

7.6
Quality 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.

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Access 2 Operator’s Guide 7.6: Quality Control Worksheet

Quality Control Worksheet

Quality Control Test ID/


Lot No. Exp. Date Type Mean SD QC Rules Applied
Name/ Level Name

12s 22s 13s 41s 10x

0784a.bmp
Figure 7-23 Quality Control Worksheet

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7.6: Quality Control Worksheet Access 2 Operator’s Guide

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Access 2 Operator’s Guide 8: Routine Maintenance

8
Routine 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

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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

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Access 2 Operator’s Guide 8.1: Routine Maintenance

8.1
Routine 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.

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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.

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Access 2 Operator’s Guide 8.1: Routine Maintenance

Maintenance Review Screen


Use 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

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8.1: Routine Maintenance Access 2 Operator’s Guide

Zone Temperature (Fields) Displays the following temperatures in degrees Celsius:


(deg C)
• 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 (Button) Select to disable and enable the automatic Utility Assay. When the Utility
Utility Assay F6 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

Running the The Utility Assay runs automatically or manually to clean the interior of the aspirate
Utility Assay 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

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Access 2 Operator’s Guide 8.1: Routine Maintenance

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:

Hours not processing samples


4 (hours) = Utility Assay repetitions * 3 (RVs) = Number of RVs needed

For example:

50 (hours)
= 12 * 3 = 36
4 (hours)
Be sure 36 RVs are loaded on the instrument.
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.

1 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).

2 Select Run Utility Assay F5.

3 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.

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8.1: Routine Maintenance Access 2 Operator’s Guide

Enabling/Dis- Use this procedure to disable the Utility Assay. Disabling the Utility Assay prevents it
abling the from running every four hours that the instrument is not processing samples.
Utility Assay
WARNING
Disable the Utility Assay while you are working on the instrument for extended
periods of time to prevent injury from the instrument accidentally starting up.

1 Go to the Maintenance Review screen. To get to this screen from the Main
Menu, select Maintenance Review F6 (see Figure 8-1).

2 Select Disable Utility Assay F6.

 To restart the timer for the Utility Assay, select Enable Utility Assay F6.

Requesting Use this procedure to request maintenance routines. You can request and load
Maintenance maintenance routines while the system is processing patient samples. The
Routines maintenance routines run after the system completes the on-board patient samples.

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

1 Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.

2 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.

3 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.

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Access 2 Operator’s Guide 8.1: Routine Maintenance

4 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

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8.1: Routine Maintenance Access 2 Operator’s Guide

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)

5 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.

6 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.

7 Load the rack and select Done F1.


For more information on loading a rack, see Section 3.1: Sample Management.

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Access 2 Operator’s Guide 8.1: Routine Maintenance

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.

8 Select Run.

9 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 Screen


Use 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.

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8.1: Routine Maintenance Access 2 Operator’s Guide

Position Rack Location Rack ID Rack Icon Rack Status

0668B.bmp
Figure 8-5 Maintenance Requests Screen

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

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Access 2 Operator’s Guide 8.1: Routine Maintenance

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 (Button) Select to display the Maintenance Review screen (see Figure 8-1).
Review F6

Table 8-6 Maintenance Requests Screen Descriptions (continued)

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8.2: Daily Maintenance Access 2 Operator’s Guide

8.2
Daily 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:

1 Check the System Status

2 Inspect the Fluidic Module

3 Clean the Wash Carousel Probe Exteriors

4 Prime the Substrate

5 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.

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Access 2 Operator’s Guide 8.2: Daily Maintenance

Main Menu Sample Manager


Inspect the
Fluidic Module*

Maintenance Review Clean the Maintenance Requests


F6
Wash Carousel F4
Probe Exteriors*
Maintenance Review
Request Maintenance

Main Menu
Check the
Run the Daily
Zone Temperatures*
Clean System*
OK
F1
Check Diagnostics
System Check the Supplies F7 Maintenance Request
Status and Waste Prime Fluidics
Containers* F2

Prime Fluidics
Main Menu

Prime the Substrate*

Place cups in rack


Configure
F8 Main Menu
PC Admin
F7

PC Admin Load the rack

Sample Manager
F1
Check the
Backup* Run

* Initial the Maintenance Log

0787C.wmf
Figure 8-7 Daily Maintenance Flowchart

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8.2: Daily Maintenance Access 2 Operator’s Guide

Daily You need to gather the following materials to perform daily maintenance. This is the
Maintenance complete list of materials for all of the procedures. For a list of part numbers and for
Required ordering information, see the instrument Instructions for Use.
Materials
WARNINGS
• You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.
• Citranox cleaning solution is acidic and may cause eye or skin irritation. 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.

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Access 2 Operator’s Guide 8.2: Daily Maintenance

Main Menu

Maintenance Review
F6

Maintenance Review

Check Zone Temperatures

Contact
Temperatures No Technical Support
in range?

Yes*

Supplies
Supplies
Correct Supply For information on adding supplies
and waste No Condition and changing waste containers,
containers
see Chapter 2: Supplies.
OK?

Yes*

Main Menu

Configure
F8
PC Admin
F7

PC Admin

Verify the backup status

Perform Immediate System Configuration


Backup For information on system backups,
Successful?
No System Backup
see Chapter 4: System Configuration
in the Reference Manual.

Yes*

Complete the remaining


Daily Maintenance
procedures

* Initial the Maintenance Log.

0592C.wmf
Figure 8-8 Daily Maintenance: Checking the System Status Flowchart

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8.2: Daily Maintenance Access 2 Operator’s Guide

Checking the Use this procedure to check the system status (see Figure 8-8).
System Status
1 Go to the Maintenance Review screen. To get to this screen from the Main
Menu, select Maintenance Review F6.

2 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.

3 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.

4 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.

5 Initial the appropriate sections of the Maintenance Log (see Section 8.6:
Maintenance Log).

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Access 2 Operator’s Guide 8.2: Daily Maintenance

Open front panel

Inspect fluidic module


for crystalline buildup or
corrosion

Is there
Contact
buildup or Yes Technical Support
corrosion?

No

Initial
Maintenance Log

0593Cwmf
Figure 8-9 Daily Maintenance: Inspecting the Fluidic Module Flowchart

Inspecting the Use this procedure to visually inspect the fluidic module (see Figure 8-9).
Fluidic
Module WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.

1 Be sure that the system is in the Ready or Not Ready mode.

2 Open the front panel of the instrument. To open the front panel, gently pull the
bottom of the panel toward you, then lift upward.

3 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.

4 Close the front panel of the instrument.

5 Initial the appropriate section of the Maintenance Log.

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8.2: Daily Maintenance Access 2 Operator’s Guide

Clean substrate
probe exterior with
deionized water

Clean dispense
probe exteriors with
deionized water

Clean aspirate
probe exteriors with
deionized water

Initial
Maintenance Log

Close front panel

0594A.wmf
Figure 8-10 Daily Maintenance: Cleaning the Wash Carousel Probe Exteriors Flowchart

Cleaning the Use this procedure to clean the exterior of the substrate, dispense, and aspirate probes.
Wash
Carousel WARNING
Probe You will come in contact with potentially infectious materials during this
Exteriors procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.

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.

1 Be sure that the system is in the Ready or Not Ready mode.

2 Open the front panel of the instrument. To open the front panel, gently pull the
bottom of the panel toward you, then lift upward.

3 Locate the substrate, dispense, and aspirate probes (see Figure 8-11).

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Access 2 Operator’s Guide 8.2: Daily Maintenance

7
6

1
5 4 3 2

1
6
3 2
5
4
0195H.eps

1 Dispense Probe 1 (Probe #1)


2 Aspirate Probe 1 (Probe #2)
3 Dispense Probe 2 (Probe #3)
4 Aspirate Probe 2 (Probe #4)
5 Dispense Probe 3 (Probe #5)
6 Aspirate Probe 3 (Probe #6)
7 Substrate Probe (Probe #7)

Figure 8-11 Dispense, Aspirate, and Substrate Probes

4 Gently wipe the exterior of the substrate probe with a new, fiber-free polyester
swab moistened with wash buffer (or deionized water).

5 Gently wipe the exterior of the dispense probes with a new, fiber-free polyester
swab moistened with wash buffer (or deionized water).

6 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.

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8.2: Daily Maintenance Access 2 Operator’s Guide

7 Close the front panel of the instrument.

8 Initial the appropriate section of the Maintenance Log.

Main Menu

Diagnostics
F7
Prime Fluidics
F2

Prime Fluidics

Select Substrate

Start Priming
F2

The system primes


the substrate
(5 minutes)

Wait until the status bar


indicates the priming
is complete

Cancel
F8

Initial
Maintenance Log

0595A.wmf
Figure 8-12 Daily Maintenance: Priming the Substrate Flowchart

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Access 2 Operator’s Guide 8.2: Daily Maintenance

Priming the Use this procedure to prime the substrate fluidic lines (see Figure 8-12). The priming
Substrate sequence takes about 8 minutes.

1 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).

2 Select the Substrate box.

 (Optional) Select the Cycles field to change the number of times the system
primes the substrate.

3 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.

4 When priming is complete, select Cancel F8 to return to the Main Menu.

5 Initial the appropriate section of the Maintenance Log.

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8.2: Daily Maintenance Access 2 Operator’s Guide

Main Menu Maintenance Requests

Sample Manager
Load Rack
F1
F1

Sample Manager

Load rack
Enter the Maintenance Rack
Number in the Rack ID field

Maintenance Request
F4 Run

Request Maintenance
The system cleans
probe interiors
Select Daily Clean (15 minutes)
System

OK
F1
Wait until the status bar
indicates the cleaning
is complete
Place 2.0 mL sample
cups in rack positions
1, 2, and 3

Unload rack

Pipette 2.0 mL
Contrad 70 into cup 1

Initial the
Maintenance Log
Pipette 2.0 mL
1/5 Citranox/deionized
water dilution into cup 2
Complete the remaining
Daily Maintenance
Pipette 2.0 mL routines
deionized water
or wash buffer
into cup 3

0596B.wmf
Figure 8-13 Daily Maintenance: Running the Daily Clean System Routine Flowchart

Running the Use this routine to clean the interior of the primary, dispense, and aspirate probes and
Daily Clean to prime the wash buffer lines (see Figure 8-13). In addition to running this routine
System during daily maintenance, you should also run this routine if you know that the
Routine

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Access 2 Operator’s Guide 8.2: Daily Maintenance

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.

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

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.

1 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).

2 Be sure that the Rack ID field is selected, then type the rack ID and press
[Enter].

The new rack is displayed in the Off Board list on the Sample Manager screen.

3 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.

4 Select the Daily Clean System option.

5 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.

6 Place the 2.0 mL sample cups in sample positions 1, 2, and 3 of an empty rack.

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8.2: Daily Maintenance Access 2 Operator’s Guide

7 Pipette 2.0 mL of Contrad 70 cleaning solution into the sample cup in


position 1.

8 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.

9 Pipette 2.0 mL of wash buffer (or deionized water) into the sample cup in
position 3.

10 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.)
If the system is processing samples, it enters the Paused mode.
The system displays a message and presents a rack position.

11 Load the rack and select Done F1.


For more information on loading a rack, see Section 3.1: Sample Management.

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.

12 Select Run.

NOTE
The Daily Clean System routine runs after the system completes the on-board
patient samples.

13 When the Daily Clean System routine is complete, unload the rack and select
Done F1.

For more information on unloading a rack, see Section 3.1: Sample


Management.

14 Initial the appropriate section of the Maintenance Log.

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Access 2 Operator’s Guide 8.3: Weekly Maintenance

8.3
Weekly 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:

1 Clean the Instrument Exterior

2 Inspect the Liquid Waste Bottle for Wear

3 Check for Fluid in the Waste Filter Bottle

4 Inspect and Clean the Primary Probe

5 Replace the Aspirate Probes

6 Clean the Aspirate Probes

7 Run Daily Maintenance (for more information, see Section 8.2: Daily
Maintenance in this chapter)

8 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.

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8.3: Weekly Maintenance Access 2 Operator’s Guide

Clean the
Instrument Exterior*

Discoloration
Inspect the Liquid
Cracking or Crazing
Waste Bottle for Wear*
Bulging

Check for Fluid in the


Waste Filter Bottle*

Inspect and Clean the


Primary Probe*

Remove the Aspirate Probes


Replace and Clean the
Install Clean Probes
Aspirate Probes*
Clean the Removed Probes

Run Daily
Maintenance*

Run System
Check*

* Initial Maintenance Log

0808C.wmf
Figure 8-14 Weekly Maintenance Flowchart

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Access 2 Operator’s Guide 8.3: Weekly Maintenance

Weekly You need to gather the following materials to perform weekly maintenance. This is
Maintenance the complete list of materials for all of the procedures. For a list of part numbers and
Required for ordering information, see the instrument Instructions for Use.
Materials
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.
• 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.
• Lint-free cloth
• Deionized or distilled water
• Maintenance Log (see Section 8.6: Maintenance Log)
• 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

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8.3: Weekly Maintenance Access 2 Operator’s Guide

Cleaning the Use this procedure to clean the exterior of the system.
Instrument
1 Moisten a clean, lint-free cloth with deionized water (or distilled water).
Exterior
2 Wipe the exterior of the instrument with the moistened cloth.

3 Initial the appropriate section of the Maintenance Log.

Inspecting the Use this procedure to inspect the liquid waste bottle for wear. Over time, the waste
Liquid Waste bottle can degrade, become brittle, and potentially crack. Any defect that is not
Bottle for removed by routine cleaning is a sign of deterioration. If you detect any issues with
Wear the waste bottle, replace the waste bottle with a clean spare bottle and discard the old
bottle.

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

1 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.

2 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.

3 Look for bulging of the waste bottle. If you detect bulging, contact Technical
Support to discuss the inspection findings and any further action.

4 Initial the appropriate section of the Maintenance Log.

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Access 2 Operator’s Guide 8.3: Weekly Maintenance

Inspect waste filter


bottle for fluid

Waste filter Replace waste filter


bottle empty?
No bottle

Yes

Initial
Maintenance Log

0600A.wmf
Figure 8-15 Weekly Maintenance: Checking for Fluid in the Waste Filter
Bottle Flowchart

Checking for Use this procedure to check the waste filter bottle for fluid.
Fluid in the
Waste Filter WARNING
Bottle You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.

1 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).

2 Initial the appropriate section of the Maintenance Log.

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8.3: Weekly Maintenance Access 2 Operator’s Guide

Open front panel

Visually inspect primary


probe for damage

Is the probe
undamaged?
No Replace primary probe

Yes

Inspect primary
probe for
crystalline buildup

Is there Initial
buildup?
No Maintenance Log

Yes

Clean primary probe


exterior with alcohol

0599C.wmf
Figure 8-16 Weekly Maintenance: Inspecting and Cleaning the
Primary Probe Flowchart

Inspecting A bent, damaged, or dirty primary probe can lead to level sensing errors. During
and Cleaning weekly maintenance, visually inspect the primary probe for damage before cleaning
the Primary the probe exterior. Use this procedure to inspect the primary probe and clean the
Probe probe exterior.

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

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1 Be sure that the system is in the Ready or Not Ready mode.

2 Open the front panel of the instrument. To open the front panel, gently pull the
bottom of the panel toward you, then lift upward.

3 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.

4 Inspect the upper portion of the primary probe for crystalline buildup (see
Figure 8-17).

0161B.eps

1 Upper Portion of Primary Probe

Figure 8-17 Primary Probe

 (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.

5 Initial the appropriate section of the Maintenance Log.

6 Close the front panel of the instrument.

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8.3: Weekly Maintenance Access 2 Operator’s Guide

Turn the
instrument off

Open the front panel


and top cover

Remove the aspirate


probe from the
wash arm

Disconnect the probe


tubing from the
barbed fitting

Install a clean
aspirate probe

Repeat for the


other two probes

Close the front panel


and top cover

Turn the
instrument on

Clean the Soak the probes in


probes within distilled water
one hour? No

Yes

Clean the removed


aspirate probes

0776C.wmf
Figure 8-18 Weekly Maintenance: Replacing the Aspirate Probes Flowchart

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Access 2 Operator’s Guide 8.3: Weekly Maintenance

Replacing the Use this procedure to replace the aspirate probes.


Aspirate
Probes Removing the Aspirate Probes

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.
• You must shut the instrument off while replacing the aspirate probes.

1 Be sure that the system is in the Ready or Not Ready mode.

2 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.

3 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.

4 Locate the aspirate probes (see Figure 8-19).

2 3

1
6

5 4 3 2

6 4
5
0152Ic.eps

1 Black Probe Retainers


2 Barbed Fittings
3 Wash Arm
4 Aspirate Probe 1 (Probe #2)
5 Aspirate Probe 2 (Probe #4)
6 Aspirate Probe 3 (Probe #6)

Figure 8-19 Aspirate Probes

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8.3: Weekly Maintenance Access 2 Operator’s Guide

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.

5 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.

6 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.

7 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).

2
4

3
0153dC.eps

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

8 Install a clean aspirate probe (see the Installing Clean Aspirate Probes
procedure in this section).

9 Repeat step 5 through step 8 to remove and install the other two aspirate probes.

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Access 2 Operator’s Guide 8.3: Weekly Maintenance

 (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.

1 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

1 Aspirate Probe Tubing


2 Barbed Fitting
3 Barbed Fitting Collar

Figure 8-21 Aspirate Probe Tubing and Barbed Fitting

2 Route the tubing under both the clear, rigid pipettor tubing and the wiring
located to the left of the pipettor gantry.

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8.3: Weekly Maintenance Access 2 Operator’s Guide

3 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.

4 While holding the probe by the black probe retainer, gently push down on the
retainer and then turn it 1/4 turn clockwise.

5 Lift gently on the probe tubing to be sure the probe moves up and down.

6 Repeat step 1 through step 5 to install the other two aspirate probes.

7 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.

8 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 Use this procedure to clean the aspirate probes.


Aspirate
Probes 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.
• 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.
• Contrad 70 cleaning solution is alkaline and may cause severe eye irritation
or mild skin irritation. See the manufacturer’s label for details.

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Access 2 Operator’s Guide 8.3: Weekly Maintenance

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.

FIll a beaker with 20 mL


of Contrad 70

Fill a beaker with 50 mL


of deionized water

Dip a new aspirate


probe brush into the
Contrad 70

Insert and remove the


probe brush in the
probe until all of the
residue is removed

Repeat for the other


two aspirate probes

0818a.wmf
Figure 8-22 Weekly Maintenance: Precleaning the Aspirate Probes
Flowchart

Precleaning the Aspirate Probes


1 Fill a small beaker with approximately 20 mL of Contrad 70 cleaning solution.

2 Fill another small beaker with approximately 50 mL of deionized water.

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8.3: Weekly Maintenance Access 2 Operator’s Guide

3 Dip the aspirate probe brush in the undiluted Contrad 70 cleaning solution.

4 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.

WARNING
Take the necessary precautions when removing and reinserting the probe brush
to avoid scattering droplets of biohazardous material into the air.

5 Remove the brush.

6 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.

7 Repeat step 3 through step 6 for the other two aspirate probes.

8 Clean the probes with Contrad 70 cleaning solution (see the Cleaning the
Aspirate Probes with Contrad 70 Cleaning Solution procedure in this section).

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Access 2 Operator’s Guide 8.3: Weekly Maintenance

Assemble the syringe

Draw the Contrad 70


into the syringe

Attach the probe to the


syringe

Empty the syringe into


the beaker

Rinse the probe by


drawing Contrad 70 into
the syringe; empty it
into the beaker

Remove the probe from


the syringe

Repeat for the other


two aspirate probes

0819a.wmf
Figure 8-23 Weekly Maintenance: Cleaning the Aspirate Probes with
Contrad 70 Cleaning Solution Flowchart

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8.3: Weekly Maintenance Access 2 Operator’s Guide

Cleaning the Aspirate Probes with Contrad 70 Cleaning


Solution
1 Attach the syringe fitting assembly onto the syringe (see Figure 8-24).

0400E.eps

1 Syringe
2 Syringe Fitting Assembly

Figure 8-24 Attaching Syringe Fitting Assembly

2 Draw the Contrad 70 cleaning solution into the syringe.

3 Push the plastic barbed fitting of the aspirate probe into the open end of the
tubing on the syringe fitting assembly.

4 Empty the syringe, forcing the Contrad 70 cleaning solution through the
aspirate probe and back into the beaker.

5 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.

6 Remove the aspirate probe tubing from the syringe fitting assembly.

7 Repeat step 2 through step 6 for the other two aspirate probes.

8 Clean the probes with distilled water (see the Cleaning the Aspirate Probes with
Distilled Water procedure in this section).

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Access 2 Operator’s Guide 8.3: Weekly Maintenance

Draw the distilled water


into the syringe

Attach the probe to the


syringe

Empty the syringe


into a sink

Rinse the probe twice


by drawing water into
the syringe; empty it
into a sink

Remove the probe from


the syringe

Clean the exterior


of the probe
with alcohol

Position the probe on


absorbent paper for
10 minutes to drain

Repeat for the other


two probes

Initial the
Maintenance Log

0778a.wmf
Figure 8-25 Weekly Maintenance: Cleaning the Aspirate Probes with
Distilled Water Flowchart

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8.3: Weekly Maintenance Access 2 Operator’s Guide

Cleaning the Aspirate Probes with Distilled Water


1 Draw distilled water from the beaker into the syringe.

2 Attach the aspirate probe tubing to the syringe fitting assembly.

3 Empty the syringe, forcing the water through the aspirate probe tubing and into
a sink.

4 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.

5 Remove the aspirate probe tubing from the syringe fitting assembly.

6 Carefully wipe the exterior of the probe with alcohol or alcohol swabs or wipes
(methanol can be substituted).

7 Position the probe upright on absorbent paper for about 10 minutes to allow
residual fluid to drain.

8 Repeat step 1 through step 7 for the other two aspirate probes.

9 Store the clean set of probes in your CARE kit or reinstall them on the
instrument.

10 Initial the appropriate section of the Maintenance Log.

Running Daily As part of weekly maintenance, you should perform daily maintenance procedures.
Maintenance 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 As part of weekly maintenance, you should run the System Check routine. For
System information about how to do this, see Section 8.4: System Check.
Check

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Access 2 Operator’s Guide 8.4: System Check

8.4
System 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.

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8.4: System Check Access 2 Operator’s Guide

System Checks Screen


The 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.

Date Run Out-of-Limit Data Points Point Cursor


0782C.bmp
Figure 8-26 System Checks Screen

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Access 2 Operator’s Guide 8.4: System Check

Out-of-Limit Data (Icons) Red triangles identify results that are above or below the expected range.
Points
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.
• Red diamonds identify results that are within the range, but the %CV is out of
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.
• Red diamonds identify results that are within the range, but the %CV is out of
range.
Wash Efficiency (Chart) Displays the results of the wash efficiency calculation within the range of
PPM 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 (Chart) Displays the substrate to washed ratio calculation within the range of
Ratio expected results (guideline only), from 0 to 1.25. Red triangles identify results that
are above or below the range.
System Check Data (Button) Select to display the System Check Data screen for the selected System
F2 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

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8.4: System Check Access 2 Operator’s Guide

System Check Data Screen


Use 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

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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 (Field) Displays the results of the substrate to washed ratio calculation.
Ratio 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.
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.
Unwashed (Field) Displays the mean RLUs, SD, and %CV of the unwashed check.
Out-of-range results (guideline only) 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.
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)

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8.4: System Check Access 2 Operator’s Guide

Viewing and Use this procedure to view the detail for the System Check results, and to print the
Printing System Check Report for a selected System Check result.
System
1 Go to the Maintenance Review screen. To get to this screen from the Main
Check Result
Menu, select Maintenance Review F6.
Data
2 Select System Checks F2.
The System Checks screen is displayed.

3 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.

4 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.

5 Select Print F7 to print the System Check Report.

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Access 2 Operator’s Guide 8.4: System Check

Laboratories, Inc.
Laboratory A
System Check Report 123 Lake Street
Access 2 Immunoassay System Townsville, ST 33333
S/N 501240 101-555-2323 ext. 109 Jane Smith

Completion: 030807 07:40 AM Value Status Limits


Wash 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 0.00-12.00
Clean 6910.75 140.01 2.03
Substrate 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 Flags
Washed 9014 2.9 1.0 N/A
Washed 8765 2.9 1.0 N/A
Washed 8761 2.9 1.0 N/A
Washed 8847 2.9 1.0 N/A
Washed 8715 2.9 1.0 N/A
Washed 8500 2.9 1.0 N/A
Washed 8239 2.9 1.0 N/A
Washed 8700 2.9 1.0 N/A
Washed 8209 2.9 1.0 N/A
Washed 8383 2.9 1.0 N/A
Clean 6964 2.9 1.0 N/A
Clean 6929 2.9 1.0 N/A
Clean 7108 2.9 1.0 N/A
Clean 6780 2.9 1.0 N/A
Clean 6772 2.9 1.0 N/A
Substrate 7241 2.9 1.0 N/A
Substrate 7081 2.9 1.0 N/A
Substrate 7621 2.9 1.0 N/A
Substrate 7084 2.9 1.0 N/A
Substrate 6837 2.9 1.0 N/A
Substrate 7005 2.9 1.0 N/A
Substrate 6791 2.9 1.0 N/A
Substrate 6799 2.9 1.0 N/A
Substrate 6847 2.9 1.0 N/A
Substrate 6963 2.9 1.0 N/A
Unwashed 5765840 2.9 1.0 N/A
Unwashed 5839490 2.9 1.0 N/A
Unwashed 5763130 2.9 1.0 N/A
Unwashed 5701660 2.9 1.0 N/A
Unwashed 5709680 2.9 1.0 N/A
Unwashed 5721760 2.9 1.0 N/A
Unwashed 5708910 2.9 1.0 N/A
Unwashed 5870080 2.9 1.1 N/A
Unwashed 5751040 2.9 1.1 N/A
Unwashed 5727800 2.9 1.1 N/A

Page 1 of 1
Technologist______________________________ Printed 03/08/07 07:41AM

0807D.bmp
Figure 8-30 System Check Report

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8.4: System Check Access 2 Operator’s Guide

Main Menu Maintenance Requests

Sample Manager Load Rack


F1 F1

Sample Manager
Load rack

Type Rack ID

Maintenance Requests Run


F4

Request Maintenance System performs


system checks
Select System Check (40 minutes)
(and Daily Clean
System, if running
weekly maintenance)

Unload rack
OK
F1

Place 2.0 mL sample


cups in rack positions Compare results with
7, 8, 9, and 10 expected values

Pipette 2.0 mL
undiluted System
Check Solution Results Repeat the
into cup 7 acceptable? No System Check

Pipette at least 1.0 mL Yes


wash buffer into cup 8

Enter values
Results
and initial Yes acceptable?
Maintenance Log, as
applicable
Leave cup 9 empty
No

Troubleshoot System
Pipette 1.0 mL Check results, or
1/501 System Check contact Technical
Solution into cup 10 Support

0601B.wmf
Figure 8-31 Running the System Check Routine Flowchart

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Access 2 Operator’s Guide 8.4: System Check

System You need to gather the following materials to perform the System Check routine. This
Check is the complete list of materials for the procedure. For a list of part numbers and for
Required ordering information, see the instrument Instructions for Use.
Materials
WARNING
System 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.

• 13 mm rack for 2 mL sample cups; the rack must have a rack ID between
1-57 or 400-456
• 2.0 mL sample cups (four 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.

• System Check Solution


• Wash buffer
• Maintenance Log (see Section 8.6: Maintenance Log)

Running the Use this procedure to run a System Check routine. After you prepare and load the
System rack, the System Check routine takes approximately 40 minutes to complete.
Check
Routine WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.

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 Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.

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8.4: System Check Access 2 Operator’s Guide

2 Be sure that the Rack ID field is selected, then type the rack ID and press
[Enter].

The new rack is displayed in the Off Board list on the Sample Manager screen.

3 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.

4 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.

5 Select OK F1.
The Maintenance Requests screen is displayed.

6 Prepare a 1/501 dilution of System Check Solution by mixing 20 μL System


Check Solution with 10.0 mL of wash buffer.

7 Place the empty 2.0 mL sample cups in sample positions 7-10 of a rack.

8 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.

9 Pipette at least 1.0 mL of wash buffer into the sample cup in position 8.

10 Leave the sample cup in position 9 empty.

11 Pipette 1.0 mL of the 1/501 diluted System Check Solution into the sample cup
in position 10.

12 Select Load Rack X F1. (The X represents the number of the rack that you
entered into the Rack ID field.)
If the system is processing samples, it enters the Paused mode.

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Access 2 Operator’s Guide 8.4: System Check

The system displays the Done window and presents a rack position.

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.

13 Load the rack and select Done F1.


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.

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.

14 Select Run.
The system displays the testing results as the samples are processed. When
processing is complete, the system runs the Utility Assay.
15 When the System Check is complete, unload the rack and select Done F1.
For more information on unloading a rack, see Section 3.1: Sample
Management.

16 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.

17 Record the results of the System Check routine in the appropriate section of the
Maintenance Log.

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8.4: System Check Access 2 Operator’s Guide

System The following results from the System Check routine should display on the System
Check Checks and System Check Data screens. For troubleshooting information, see
Expected Appendix A: Troubleshooting in the Reference Manual.
Results
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* 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** 0 to 1.25**

Table 8-32 System Check Routine Expected Results


* 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.
** Not a system specification. It should be used for reference purposes only.

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Access 2 Operator’s Guide 8.5: Special Clean

8.5
Special 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.

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8.5: Special Clean Access 2 Operator’s Guide

Main Menu Maintenance Requests

Sample Manager Load Rack


F1 F1

Sample Manager

Load rack
Enter the Maintenance Rack
Number in the Rack ID field

Maintenance Request
F4 Run

Request Maintenance
The system cleans
probe interiors
(30 minutes)
Select Special Clean

OK
F1
Wait until the status bar
indicates the cleaning
is complete
Place 2.0 mL sample
cups in rack positions
1, 2, 3, 4, 5, and 6

Unload rack

Pipette 2.0 mL
Contrad 70 into cup 1

Pipette 2.0 mL
1/5 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

0810C.wmf
Figure 8-33 Special Clean Routine Flowchart

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Access 2 Operator’s Guide 8.5: Special Clean

Special Clean Gather the following materials to perform the Special Clean routine. For a list of part
Routine numbers and for ordering information, see the instrument Instructions for Use.
Required
Materials 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.
• Contrad 70 cleaning solution is alkaline and may cause severe eye irritation
or mild skin irritation. See the manufacturer’s label for details.
• Citranox cleaning solution is acidic and may cause eye or 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.
• 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.
• 13 mm rack for 2 mL sample cups; the rack must have a rack ID between
1-57 or 400-456
• 2.0 mL sample cups (six 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.

• 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 Use this procedure to run the Special Clean routine. After you prepare and load the
Special Clean rack, the Special Clean routine takes approximately 35 minutes to complete.
Routine

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8.5: Special Clean Access 2 Operator’s Guide

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

NOTE
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 Go to the Sample Manager screen. To get to this screen from the Main Menu,
select Sample Manager F1.

2 Be sure that the Rack ID field is selected, then type the rack ID and press
[Enter].

The new rack is displayed in the Off Board list on the Sample Manager screen.

3 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.

4 Select the Special Clean option.

5 Select OK F1.

6 Place empty 2.0 mL sample cups in sample positions 1, 2, 3, 4, 5, and 6 of the


rack.

7 Pipette 2.0 mL of Contrad 70 cleaning solution into the sample cup in


position 1.

8 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.

9 Pipette 2.0 mL of deionized water into the sample cup in position 3.

WARNING
Ethanol 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.

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Access 2 Operator’s Guide 8.5: Special Clean

10 Pipette 2.0 mL of 70% ethanol* into each of the cups in sample positions 4, 5,
and 6.

Sample
1 2 3 4, 5, 6
Position

Add 2.0 mL Contrad 70 1/5 Citranox Deionized 70% Ethanol*


Water

11 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.)
If the system is processing samples, it enters the Paused mode.
The system displays the Done window and presents a rack position.

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.

12 Load the rack and select Done F1.


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.

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.

13 Select Run.

14 When the Special Clean is complete, unload the rack and select Done F1.
For more information on unloading a rack, see Section 3.1: Sample
Management.

* Alternatively, a 70% methanol solution may be used—mix 7 parts methanol and 3 parts wash buffer

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8.6: Maintenance Log Access 2 Operator’s Guide

8.6
Maintenance 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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Access 2 Maintenance Log Serial # ____________ System ID ____________ Month ____________ Year ________ Beckman Coulter, Inc.
Perform the tasks listed at the left and draw a check () in the accompanying box on the right. Initial the Tech Initials box.
DAILY MAINTENANCE 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31

Check Zone Temperatures


Check System Supplies
Empty Liquid Waste Bottle
System Backup Successful?

P/N B14251D 9/14


Inspect Fluidic Module
Clean Probe Exteriors
8.6: Maintenance Log

Prime Substrate

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Run Daily Clean System
(If Necessary)
Perform Special Clean
Tech Initials

Perform the tasks listed at the left and draw a check () in the accompanying box on the right. Initial the Tech Initials box.
WEEKLY MAINTENANCE Week 1 Week 2 Week 3 Week 4 Week 5
Today’s Date
Clean Instrument Exterior
Inspect Liquid Waste Bottle
Check Waste Filter Bottle
Inspect/Clean Primary Probe
Replace/Clean Aspirate Probes
Run Daily Maintenance (Initial above) (Initial above) (Initial above) (Initial above) (Initial above)
Run System Check
Tech Initials

Enter the System Check Results in the boxes. Initial the Tech Initials box.
SYSTEM CHECK RESULTS Week 1 Week 2 Week 3 Week 4 Week 5 Expected Results
Today’s Date
Washed RLU/%CV 5,000 to 20,000 / ≤12.00
* The Substrate : Washed
Substrate RLU/%CV 5,000 to 9,000 / ≤5.00 Ratio and the Unwashed
Check RLU mean result
Unwashed RLU/%CV 4 to 10 million* / ≤2.00
are not system
Wash Efficiency PPM -1.0 to +1.0 specifications. They are
only reference
Substrate Ratio 0 to 1.40
guidelines.
Access 2 Operator’s Guide

Substrate : Washed Ratio 0 to 1.25*

8-63
Tech Initials
This page may be reproduced for laboratory use.
8.6: Maintenance Log Access 2 Operator’s Guide

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Access 2 Operator’s Guide A: Racks and Sample Containers

A
Racks 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

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A.1: Racks Access 2 Operator’s Guide

A.1
Racks
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.

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Access 2 Operator’s Guide A.1: Racks

Sample Container Rack Rack IDs

1 - 99 or
Access 2.0 mL/13 mm Sample Cup 13 mm 400 - 499
Access 2.0 mL/16 mm Insert Cup in 16 x 100 mm Tube 16 x 100 mm 200 - 299
13 mm or
Access 3.0 mL Sample Container 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
16 x 75 mm Elevated Tube ELEV 1000 - 1099
12 x 75 mm Tube, with or without separator gel or
13 x 75 mm Tube, with or without separator gel 13 mm 1300 - 1399
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 x 100 mm Tube, with or without separator gel 13 mm 1400 - 1499
Note: 13 x 100 mm tubes may also be used with Rack IDs 1 - 99 or
100 - 199.
16 x 100 mm Tube, with or without separator gel 16 x 100 mm 1500 - 1599
Note: 16 x 100 mm tubes may also be used with Rack IDs 900 - 999.

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 13 mm 2100 - 2199
16 x 75 mm
75 x 15 mm 5.5 mL Sarstedt S-Monovette Tube 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
* Monovette is a trademark of Sarstedt A.G. & Co.

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A.1: Racks Access 2 Operator’s Guide

Attaching To be sure that the internal bar code reader can accurately read the rack bar code label,
Rack Bar use this procedure to place the label on a rack.
Code Labels
1 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.

2
3

05

05

05 1

0126C.eps
R

1 0-1 mm

2 Handle

3 Spine

Figure A-2 Rack Bar Code Label Placement

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

3 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 Clean racks in a dishwasher or autoclave, or use a brush and a mild detergent.
Racks

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Access 2 Operator’s Guide A.2: Sample Containers

A.2
Sample 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.
• Remove caps from all sample containers before loading on the Access 2
system.

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.

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A.2: Sample Containers Access 2 Operator’s Guide

Calculating To be sure the sample volume is sufficient for the tests to be run, calculate the total
Sufficient volume of sample needed for the sample container by using this equation:
Sample
Volume Sample volume
Number of Total sample
required per x replicates + Dead volume = volume required
replicate

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.

WARNING
If 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 To be sure the internal bar code reader can correctly read the sample bar code label,
Sample Bar use this procedure to place a label on a sample container.
Code Labels
WARNING
You will come in contact with potentially infectious materials during this
procedure. Handle and dispose of biohazard materials according to proper
laboratory procedures. Proper hand, eye, and facial protection is required.

NOTE
The internal bar code reader automatically discriminates between symbologies,
so 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).

1 Place the bar code label on the sample container so that the label is at least 0.25
inches from the top and bottom of the container (see Figure A-3). Be sure that it
is securely fastened.

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Access 2 Operator’s Guide A.2: Sample Containers

2 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.

ABC123456789

ABC123456789
2
0124D.eps

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

Using Insert An insert cup has a smaller sample volume requirement and a smaller dead volume
Cups in Bar than a sample tube. You may need to transfer sample from a sample tube to an insert
Coded cup to meet the total sample volume required for testing.
Sample
Use this procedure to add an insert cup to a bar-coded sample tube.
Containers
WARNING
Carefully 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.

1 Transfer the required sample volume from the sample tube with a bar code label
into the insert cup.

2 Place the cup back into the original sample tube, which has the bar code label
attached (see Figure A-4).

3 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.

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A.2: Sample Containers Access 2 Operator’s Guide

ABC123456789

XXX

3
0127D.eps

1 Insert Cup

2 Sample Tube

3 Rack ID

Figure A-4 Loading Insert Cups

Access 2 The following table lists all of the sample containers you can currently use on the
System Access 2 instrument, the corresponding rack ID range and the dead volume for each
Sample container.
Containers
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.
• Remove caps from all sample containers before loading on the Access 2
system.

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Access 2 Operator’s Guide A.2: Sample Containers

Sample Container Information Bar Code Sample Container Information Bar Code
Label Icon Label Icon

13 x 75 mm Tube with or without 13 x 100 mm Tube with or without


separator gel separator gel

13x100 GEL
13x75 GEL
• Border: Lime green • Border: Forest green

13x100
13x75
• Rack IDs: 1300 - 1399 • Rack IDs: 1400 - 1499
• Dead Volume: 500 µL • Dead Volume: 3.0 mL
NOTE: 13 x 75 mm tubes may also be NOTE: 13 x 100 mm tubes may also be
used with Rack IDs 1 - 99 or 800 - 899, at used with Rack IDs 1 - 99 or 100 - 199, at
a Dead Volume of 3.4 mL. a Dead Volume of 4.9 mL.

12 x 75 mm Tube with or without 16 x 100 mm Tube with or without


separator gel separator gel
12x75

16x100 GEL

16x100
• Border: Lime green • Border: Midnight blue
• Rack IDs: 1300 - 1399 • Rack IDs: 1500 - 1599
• Dead Volume: 500 μL • Dead Volume: 4.5 mL
NOTE: 12 x 75 mm tubes may also be NOTE: 16 x 100 mm tubes may also be
used with Rack IDs 1 - 99, at a Dead used with Rack IDs 900 - 999, at a Dead
Volume of 3.4 mL. Volume of 7.6 mL.

16 x 75 mm Elevated Tube Access 3.0 mL Sample Container


• Border: Purple • Border: Red
16x75

• Rack IDs: 1000 - 1099 • Rack IDs: 500 - 599


• Dead Volume: 700 μL • Dead Volume: 150 μL

Access 2.0 mL/13 mm Sample Cup Access 1.0 mL/13 mm Insert Cup
• Border: Dark green in 13 x 100 mm Tube

• Rack IDs: 1 - 99 or 400 - 499 • Border: Blue


13x100

2.0 mL
(only 400 - 499 have the icon) • Rack IDs: 600 - 699
• Dead Volume: 150 μL • Dead Volume: 400 μL

Table A-5 Sample Containers with Rack and Volume Requirements

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A.2: Sample Containers Access 2 Operator’s Guide

Sample Container Information Bar Code Sample Container Information Bar Code
Label Icon Label Icon

Access 1.0 mL/13 mm Insert Cup Beckman Coulter 0.5 mL Cup


in 13 x 75 mm Tube • Border: Light pink
• Border: Light green • Rack IDs: 2500 - 2599

13x75
• Rack IDs: 700 - 799
0.5 mL
• Dead Volume: 80 μL
• Dead Volume: 300 μL
Auto Aliquot Tube, 13 x 100 mm Access 2.0 mL/16 mm Insert Cup

Autoaliquot
false bottom in 16 x 100 mm Tube
• Border: Purple • Border: Orange

16 mm
• Rack IDs: 1600 - 1699 • Rack IDs: 200 - 299
• Dead Volume: 400 μL • Dead Volume: 400 μL

Access 2 Pediatric Insert Cup in Sarstedt S-Monovette Tube,


Pediatric Tube Adapter for 13 mm 90 x 13 mm 4.9 mL

Sarstedt
rack • Border: Dark brown
Pediatric

• Border: Pink • Rack IDs: 2100 - 2199


• Rack IDs: 1800 - 1899 • Dead Volume: 3 mL 4.9 mL
• Dead Volume: 100 μL

Sarstedt S-Monovette Tube, Sarstedt S-Monovette Tube,


75 x 15 mm 5.5 mL 92 x 15 mm 7.5 mL
Sarstedt

• Border: Red-brown • Border: Light brown Sarstedt


• Rack IDs: 2200 - 2299 • Rack IDs: 2300 - 2399
• Dead Volume: 3.6 mL • Dead Volume: 5 mL
5.5 mL
7.5 mL
Sarstedt S-Monovette Tube,
92 x 16 mm 9 mL
Sarstedt

• Border: Gray-brown
• Rack IDs: 2400 - 2499
• Dead Volume: 6 mL
9.0 mL

Table A-5 Sample Containers with Rack and Volume Requirements (continued)

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Access 2 Operator’s Guide Index

Index

A
B
Access 2 System Documentation Preface-3
B12
Active Calibrations
See Vitamin B12 Assay
Defined 6-9
Switching with Previous 6-16 Back Tab 1-24
Analytical Module 1-4 Backups
Daily Maintenance 8-18
APFs, Software Overview 1-13
Bar Code Labels
Arrow Button Preface-10
Attaching rack A-4
Aspirate Probes
Attaching sample A-6
Cleaning 8-38
Rack A-2
Cleaning with Contrad 70 Solution 8-42
Rack placement A-4
Cleaning with Distilled Water 8-44
Sample A-6, A-7
Disconnecting Tubing 8-36
Sample Placement A-7
Installing Clean 8-37
Bar Code Readers
Precleaning 8-39
Entering Tests While Disabled 3-31
Removing 8-35
Handheld Scanning Procedure 2-5
Replacing 8-35
Internal 3-7
Replacing and Cleaning (Flowchart)
8-34 Scanning Containers in Racks 3-10
Scanning for LIS Requests 3-28
Assay Protocol Files (APFs) 1-13
Wand Scanning Procedure 2-4
Assays
Working with On-Board Samples 3-50
Calibrations 6-1, 6-2
Bar Codes
Qualitative Cutoffs 6-2
Manually Scanning 2-4
Quality Controls 7-3
Scanning Reagent Pack 2-36
Quantitative Curves 6-2
Reviewing Calibration Data 6-8 Batch Request
Semi-Quantitative Curves 6-2 Using 3-37
Utility Assay 8-6 Using (Flowchart) 3-36

Attention Safety Symbol 1-6 Batteries


EU Directive 1-10
Auto Sample ID
Safe Disposal 1-10
Using 3-35
Using (Flowchart) 3-34 Beckman Coulter
0.5 mL cup A-3
Contact Information Preface-16

 2014 Beckman Coulter, Inc. Index-1


P/N B14251D 9/14
Index Access 2 Operator’s Guide

Biohazard Safety Symbols 1-7 Previous Active 6-9


Buffer, Wash Printing a Report 6-18
See Wash Buffer Report 6-19
Buttons Reports 6-17
Cancel F8 1-28 Request Window 3-40
Common Descriptions 1-28 Requests 3-25
Function 1-24 Sample Management 3-3
Help F12 1-28 Screen 6-4
Highlighted in the Text Preface-7 Stored Data 6-9
Main Menu Function 1-14 Supply and Conditions 4-11
OK F1 1-28 Supply Status 2-3
System Command 1-20 Switching Active with Previous 6-16
System Status Preface-7, 1-21, 2-3, 2-4 Test Menu 3-41
Window View Preface-10 Test Requests 3-38
Verifying Conditions 4-16
Verifying Expirations 4-11
C Viewing Curves or Cutoffs 6-15
Calculations, Quality Control 7-3 Calibrators
Deleting Data Points 7-18 Add Window 6-26
Omitting Data 7-15 Adding 6-26
Omitting Data Points 7-17 Adding (Flowchart) 6-25
Calculations, Sample Volume A-6 Deleting 6-28
Calibration Conditions 4-11 Editing 6-27
Calibration Controls Setting Up 6-22
See Calibrators Setup Screen 6-23
Calibration Test Requests Canadian Standards Association Label 1-9
Entering 3-40 Carousel Module 1-4
Entering (Flowchart) 3-39 Cautions
Calibrations Indicators of Instrument Damage
Active 6-9 Preface-16

Adding a Comment 6-16 Instrument 1-8


Applying a Filter 6-6 Radio Frequency 1-12
Assay 6-1 CE Mark Label 1-9
Assay Overview 6-2 Change Substrate Window 2-19
Calibrator Setup 6-22 Chapter Organization Preface-6
Data Report (Curve) 6-21
CISPR 11 Compliance 1-11, 1-12
Data Report (Cutoff) 6-20
Citranox Cleaner
Data Review 6-8
Daily Maintenance 8-16
Data Screen (Curve) 6-11
Safe Handling 8-16
Data Screen (Cutoff) 6-10
Special Clean Routine 8-59
Deleting 6-7
Entering Test Requests 3-40 Cleaning
Failure Codes 6-14 Aspirate Probes 8-38
Flowchart 6-3 Instrument Exterior 8-30
Last Run 6-9 Primary Probe 8-32
Overriding Expired 4-16 Probe Exteriors 8-20

Index-2  2014 Beckman Coulter, Inc.


P/N B14251D 9/14
Access 2 Operator’s Guide Index

Racks A-4 Running 8-24


Special Clean Routine 8-57 Daily Maintenance
Comments Checking System Status 8-18
Adding to Calibration 6-16 Checking System Status (Flowchart)
Entering for Sample 3-16 8-17
Entering QC 3-47, 7-17 Cleaning Probes 8-20
Notepad Button 3-16 Cleaning the Wash Carousel Probe
Pen Button 3-16 Exteriors (Flowchart) 8-20
Daily Clean System 8-24
Configuring
Daily Clean System Routine (Flowchart)
Calibrators 6-22
8-24
Test Results Screen 5-28
During Weekly Maintenance 8-44
Consumables 2-3 Flowchart 8-15
Contamination Inspecting Fluidics 8-19
Substrate 2-20 Inspecting the Fluidic Module
Wash Buffer 2-11 (Flowchart) 8-19
Continuous Access 1-3 Overview 8-14
Sample Processing 4-3 Priming Substrate 8-23
Working with On-Board Samples 3-48 Priming the Substrate (Flowchart) 8-22
Contrad Cleaning Solution Required Materials 8-16
Daily Maintenance 8-16 Data Management
Safe Handling 8-16 Copying Test Results 5-36
Special Clean Routine 8-59 Test Results 5-31
Weekly Maintenance 8-29, 8-38 Data Points, Omitting QC 7-17
Controls, Quality Dead Volume
See Quality Controls By Sample Container A-8
Copying Data Definition A-6
Quality Controls 7-19 Decontaminate, Liquid Waste Bottle 2-15
Test Results 5-36 Disks
C-Tick Mark 1-9 Copying QC Data 7-19
Cups Copying Test Results 5-36
See Sample Containers Dispense Cap Assembly 2-12
Curves Disposal
Quantitative 6-2 RoHS Standard 1-11
Viewing Assay Calibrations 6-15 WEEE Directive 1-10
Cutoffs Documentation
Qualitative 6-2 LIS Vendor Preface-6
Viewing Assay Calibrations 6-15 System Preface-3
Download
D LIS and Work Pending 4-19
LIS Container Assignment 4-8
Daily Clean System
LIS Sample Processing 4-2
Daily Maintenance 8-14
Definition 8-9
Flowchart 8-24 E
Maintenance Routine 8-9 Electrical Safety Symbol 1-6

 2014 Beckman Coulter, Inc. Index-3


P/N B14251D 9/14
Index Access 2 Operator’s Guide

Electronics Module 1-4 Finding Test Results 5-22


Electrostatic Discharge (ESD) Safety Symbol QC Chart and Data 7-15
1-8 Quality Controls 7-7
Elevated Tube A-3 Reagent Inventory 2-46
Emissions, Radio Frequency 1-11 Test Results, System-Defined 5-11
Work Pending 4-22
Environmental
Also See Regulatory Find Feature in Help Preface-14
RoHS Marks 1-11 Flags
Errors, Resolving Sample 3-14 See Test Result Flags

Evaporation, Sample 3-9 Flash Drives


Copying QC Data 7-19
Example Button Preface-10
Copying Test Results 5-36
Exclamation Point Label 1-6
Flowchart Button Preface-10
Expiration Date
Flowcharts
Calibration 6-8
Adding a Calibrator 6-25
Quality Control 7-31
Applying a Test Result Filter 5-11
Reagent Lot 2-31, 2-40
Calibration 6-3
Reagent Pack 2-40
Changing the Liquid Waste Bottle 2-14
Substrate Open Bottle 2-17
Changing the RV Waste Bag 2-29
Expired
Changing the Substrate Bottle 2-18
Overriding Supply Conditions 4-16
Changing the Wash Buffer Bottle 2-11
Reagent Lots 4-11
Checking for Fluid in the Waste Filter
Reagent Packs 4-11 Bottle 8-31
Substrate 4-11 Checking System Status 8-17
Cleaning Primary Probe Exterior 8-32
F Cleaning Probe Exteriors 8-20
Failure Codes, Calibration 6-14 Comparing QC Charts 7-24
Configuring the Test Results Screen 5-28
FCC Compliance 1-11
Copying Test Results to a Disk or USB
Fields Flash Drive 5-35
Available 1-25 Daily Clean System 8-24
Information 1-25 Daily Maintenance 8-15
List 1-25 Defining a Test Result Filter 5-18
Names Highlighted in the Text Preface-7 Deleting a Reagent Pack 2-48
Selecting and Entering 1-27 Deleting a Test Result 5-40
Unavailable 1-25 Editing a Test Result Filter 5-14
Filters Editing Test Requests for On-Board
About Test Results 5-9 Samples 3-51
Applying a QC 7-7 Entering Calibration Test Requests 3-39
Applying a Test Result 5-11 Entering Patient Test Requests Manually
Applying a Test Result (Flowchart) 5-11 3-30

Calibration 6-6 Entering Quality Control Test Requests


3-44
Defining a Test Result 5-19
Finding a Test Result 5-22
Defining a Test Result (Flowchart) 5-18
Inspecting the Fluidic Module 8-19
Deleting a Test Result 5-20
Loading a Reagent Pack 2-32
Editing a Test Result 5-15
Loading RVs 2-25
Editing a Test Result (Flowchart) 5-14

Index-4  2014 Beckman Coulter, Inc.


P/N B14251D 9/14
Access 2 Operator’s Guide Index

Priming Substrate 8-22 Warnings Preface-16


Printing Test Result Reports 5-44 Window Button Bar Preface-12
Processing LIS Test Requests 3-27 Window Menu Preface-13
Processing Samples 4-4 Windows Preface-11
Quality Controls 7-4 Help Buttons
Replacing and Cleaning Aspirate Probes Arrow Preface-10
8-34
Example Preface-10
Running System Checks 8-52 Flowchart Preface-10
Sample Management 3-4 Links Preface-10
Sending Test Results to the LIS 5-32 More Info Preface-11
Setting Up Quality Controls 7-32 Navigation Preface-10
Special Clean Routine 8-58 Screen View Preface-10
Test Results 5-3 See Also Preface-10
Unloading a Reagent Pack 2-37 Show Me Preface-10
Using Auto Sample ID 3-34
Highlighted Text (Green) Preface-15
Using Batch Request 3-36
Host Query 4-8
Viewing Sample Details (Test Results)
5-25
Weekly Maintenance 8-28 I
Working with On-Board Samples 3-49 ID
Fluidic Module 1-4 See Rack IDs
Inspecting 8-19 See Sample IDs
Inspecting (Flowchart) 8-19 IEC Compliance 1-11
Formulas Index in Help Preface-14
Required RVs for Utility Assay 8-7
Infectious, Biohazard Symbol 1-7
Sample Volume A-6
Insert Cups
Function Buttons 1-24
In Bar Coded Sample Containers A-7
Loading A-8
G Inspecting
Glossary Fluidic Module 8-19
Help Link Button Preface-11 Liquid Waste Bottle 8-30
Help Window Button Bar Preface-12 Primary Probe 8-32
Samples 3-9
H Installation 1-5
No Other Applications 1-14
Help
Cautions Preface-16 Instrument
Exiting System Preface-11 Cautions Regarding Possible Damage
Preface-16
Find Feature Preface-14
Cleaning the Exterior 8-30
Glossary Preface-12
Instructions for Use Preface-5
Index Preface-14
Overview 1-4
Notes Preface-16
Software 1-13
Print Preface-12
System Preface-5 Insufficient Sample Volume 3-6
Topics Window Preface-13 Interlock Switch 1-5
Using the Help System Preface-8

 2014 Beckman Coulter, Inc. Index-5


P/N B14251D 9/14
Index Access 2 Operator’s Guide

Work Pending 4-19


L Work Pending Filter 4-22
Labels Workpool 4-8
Attaching Rack Bar Code A-4 LIS Vendor Information Document Preface-6
Attaching Sample Bar Code A-6 LIS Workpool
Rack Bar Code A-2 Assignment Rules 4-8
Rack Bar Code Placement A-4 Container Assignment 4-8
Regulatory 1-9 Work Pending Screen 4-21
Safety Symbols 1-6 Loading
Sample Bar Code A-6, A-7 Racks 3-11
Sample Bar Code Placement A-7 Reagent Packs 2-33
Laboratory Information System (LIS) RVs 2-25
See LIS Samples in Racks 3-9
Laser Safety Symbol 1-8 Logs
Last Run Calibrations, Defined 6-9 Also See Worksheets
LED Safety 1-12 Maintenance 8-62

Levey-Jennings Charts
Compare Charts Screen 7-22 M
Comparing 7-25 Main Menu 1-14, 1-15
Description 7-10 Tab 1-24
Quality Control Screen 7-5 Workflow 1-17
Reviewing 7-9 Main Menu Function Buttons 1-14
Liquid Waste Calibration Review 1-16
Bottle 2-13, 2-16 Configure 1-17
Button 2-13, 4-13, 4-20 Diagnostics 1-17
Changing the Bottle 2-15 Maintenance Review 1-16
Changing the Bottle (Flowchart) 2-14 Quality Control 1-16
Drain Kit 2-13 Sample Manager 1-15
Inspecting Bottle for Wear 8-30 Supplies 1-16
Supplies 2-3 Test Results 1-16
Supplies Overview 2-13 Main Pipettor Module 1-4
Supply Status 2-3
Maintenance
Verifying Bottle Capacity 4-11
Daily 8-14
LIS Fluidics Inspection 8-19
Container Assignment 4-8 Log 8-62
LIS Vendor Information Document Maintenance Requests Screen 8-11, 8-12
Preface-6
Priming Substrate 8-23
Processing Patient Test Requests 3-27
Requesting Maintenance Routines 8-8
Resending Fail Status 5-32
Review Screen 8-5
Sample Management 3-3
Routine 8-3
Sending Test Results to 5-32
Running System Checks 8-53
Sending Test Results to (Flowchart) 5-32
Sample Management 3-3
Software Feature 1-14
Special Clean 8-57
Status for Test Results 5-2, 5-6
Special Clean Routine 8-59
Test Request 4-2
System Checks 8-45

Index-6  2014 Beckman Coulter, Inc.


P/N B14251D 9/14
Access 2 Operator’s Guide Index

Utility Assay, Enabling or Disabling 8-8 Deleting Test Requests for 3-54
Viewing System Check Data 8-50 Deleting Test Requests for (Flowchart)
Weekly 8-27 3-53

Maintenance Log 8-62 Editing Test Requests for 3-52


Rearranging 3-49
Manuals
Removing 3-49
Chapter Organization Preface-6
Working with 3-48
Instrument Instructions for Use
Preface-5 Working with (Flowchart) 3-49
Material Safety Data Sheet Preface-6 Online
Online Preface-6 Manuals Preface-6
Reference Manual Preface-3 Support, USA and Canada Preface-16
Required and Optional Steps Preface-8 Optional Steps Preface-7
Using this Manual Preface-6 Overriding 4-16
Material Safety Data Sheet Manual Preface-6
Mean RLU P
Substrate Check Expected Results 8-56
Packs
Unwashed Check Expected Results 8-56
See Reagent Packs
Washed Check Expected Results 8-56
Padlock
Menu Tab 1-24
Reagent Pack In Use 2-7
Menus Unloading Reagent 2-37
Calibration Test 3-41
Password Protected
QC Test 3-46
See Secured Operations
Modes, System 1-19
Password Setup 1-17
Modules
Patient Report 5-47
Analytical 1-4
Patient Test Requests
Carousel 1-4
Batch Request 3-37
Electronics 1-4
Entering Manually 3-31
Fluidic 1-4
Entering Manually (Flowchart) 3-30
Main Pipettor 1-4
Overview 3-19
Peripheral 1-4
Processing LIS 3-27
More Info Button Preface-11
Using Auto Sample ID 3-35
Moving Parts Safety Symbol 1-7
Pause Button
Description 1-20
N Pausing Sample Processing 4-5
Navigation Using to Add Tests to On-Board
Keyboard Equivalents 1-26 Samples 3-56
System 1-26 Using to Delete Tests from On-Board
Samples 3-58
Test Requests Screen 3-26
Pen Button 3-16
Navigation Button Preface-10
Peripherals Module 1-4
Notepad Button 3-16
PPM, Wash Efficiency 8-56
Previous Active Calibrations
O
Defined 6-9
On-Board Samples Switching with Active 6-16
Adding 3-49

 2014 Beckman Coulter, Inc. Index-7


P/N B14251D 9/14
Index Access 2 Operator’s Guide

Primary Probe Saving Comparisons 7-25


Cleaning the Exterior 8-32 QC Charts and Data
Cleaning the Exterior (Flowchart) 8-32 Filter 7-15
Inspecting 8-32 Viewing 7-15
Priming Substrate 8-23 QC Comparisons
Printing Deleting 7-8
Also See Reports QC Charts 7-25
Calibration Reports 6-18 Saving 7-25
Help Preface-12 QC Rules
QC Chart and Data Report 7-28 See Westgard QC Rules
QC Reports 7-26 Qualitative
Reagent Inventory Report 2-49 Assay Calibrations 6-2
Supplies Required Report 4-17 Cutoffs 6-2
System Check Reports 8-50
Quality Control Test Requests
Test Result Reports 5-44
Entering 3-45
Work Pending Report 4-24
Entering (Flowchart) 3-44
Probes Overview 3-43
Cleaning the Primary 8-32
Quality Controls 7-1
Cleaning Wash Carousel 8-20
Adding 7-34
Button 7-5
Q Calculations 7-3
QC Charts and Data, Viewing 7-15
Also See Quality Controls Compare Charts Screen 7-21
Chart and Data Screen 7-11 Copying Data 7-19
Collecting Data for Ranges 7-39 Data 7-3
Comparing Charts 7-25 Data Out of Range 7-10
Comparing Charts (Flowchart) 7-24 Deleting 7-37
Establishing Ranges 7-39 Deleting Chart Comparisons 7-8
Filter Applying 7-7 Editing 7-37
Point Deleting 7-18 Entering Comments for QC Data 7-17
QC Chart Report 7-30 Entering Tests 3-45
QC Data Report 7-29 Establishing Ranges 7-39
QC Review Report 7-27 Filter 7-7
Reports 7-26 Flowchart 7-4
Saving Comparisons 7-25 Omitting Data Points 7-17
Setup Screen 7-33 Overview 7-3
Temporary Ranges 7-41 Printing Reports 7-26
Westgard QC Rules 7-9 Ranges, Collecting Data for 7-39
QC Charts Ranges, Temporary 7-41
Comparing 7-21, 7-25 Reports 7-26
Comparing (Flowchart) 7-24 Requests 3-25
Deleting Comparisons 7-8 Reviewing Data 7-9
Levey-Jennings 7-10 Reviewing Levey-Jennings Charts 7-9
Printing Report 7-28 Sample Management 3-3
Reviewing 7-9 Screen 7-5
Setting Up 7-31

Index-8  2014 Beckman Coulter, Inc.


P/N B14251D 9/14
Access 2 Operator’s Guide Index

Setting Up (Flowchart) 7-32 Random Access 1-3


Setting Up (Worksheet) 7-42 Ranges
Test Requests 3-43 Collecting Data for QC 7-39
Westgard QC Rules 7-9 Establishing QC 7-39
Worksheet 7-42, 7-43 Quality Control 7-39, 7-41
Quantitative Temporary QC 7-41
Assay Calibrations 6-2 Ratios
Curves 6-2 System Check Substrate 8-56
Query, Host 4-8 System Check Substrate : Washed 8-56
Quick Reference Guide Reaction Vessels
Instrument Instructions for Use See RVs
Preface-5
Reagent Carousel
Loading Reagent Packs 2-35
R Misplaced Packs 2-39
Rack Bar Code Labels Unloading Reagent Packs 2-38
Attaching A-4 Reagent Inventory
Instrument Scanning A-2 Applying a Filter to the Screen 2-45
Placement A-4 Deleting Reagent Packs 2-48
Rack IDs Overview 2-40
Changing 3-15 Printing the Report 2-49
Sample Container Ranges A-8 Report 2-50
Sample Containers A-3 Screen 2-42
Unique for Workgroup 3-11 Reagent Lot Number
Rack Status Changing for Calibration 3-17
Aspiration 3-7 Changing For QC 3-17
Completion Time 3-7 Expired 4-11
Field on Test Requests Screen 3-21 Reagent Packs
Monitoring 4-25 Bar Code Scanning 2-36
Rack Button 3-6 Deleting (Flowchart) 2-48
Sample Manager Descriptions 4-26 Deleting from Inventory 2-48
Unloading Racks 3-13 Expired 4-11
Racks Inventory 2-40
Cleaning A-4 Load Window 2-34
Clearing 3-16 Loading 2-33
Loading 3-11, 3-12 Loading (Flowchart) 2-32
Loading Restriction 4-3 Loading into the Reagent Carousel 2-35
Overview A-2 Mixing 2-34
Placing Sample Containers in 3-9 Monitoring 2-31
Processing Status 4-25 Overview 2-31
Sample Containers A-3 Retrieving Misplaced 2-39
Unloading 3-12 Supplies 2-3
Supplies Required Button 2-31
Radio Frequency
Supply Status 2-3
Cautions 1-12
Unloading 2-37
Emissions 1-11
Unloading (Flowchart) 2-37
Interference 1-12
Verifying Unexpired Supply 4-11

 2014 Beckman Coulter, Inc. Index-9


P/N B14251D 9/14
Index Access 2 Operator’s Guide

Recycling Selected Test Results 5-49


RoHS Standard 1-11 Standard Information 1-29, 1-30
WEEE Directive 1-10 Supplies Required 4-17, 4-18
Reference Manual Preface-3 System Check 8-51
Reflex Tests Test Results 5-42
Counted in Tests Requested 4-13 Work Pending 4-24
Rack Removal 4-25 Requests
Removing Aspirated Samples 3-50 Entering Calibration Test 3-40
Work Pending 4-19 Entering Calibration Test (Flowchart)
3-39
Work Pending Filter 4-22
Entering Quality Control Test 3-45
Refrigeration
Entering Quality Control Test
Maintaining Temperature 8-6
(Flowchart) 3-44
Storing Reagent 2-38
Maintenance Routines 8-8
Regulatory Patient Test 3-19
Australian Communications Authority Processing LIS Patient Test 3-27
1-9
Processing LIS Test (Flowchart) 3-27
Battery Directive 1-10
Using Batch (Flowchart) 3-36
Canadian Standards Association 1-9
Rerun Tests
CE Mark 1-9
Work Pending 4-19
CSA Symbol 1-9
Work Pending Filter 4-22
C-Tick Mark 1-9
EU Directives 1-9, 1-10 Reservoir Receptacle 2-12
Radio Frequency Emissions 1-11 Result Flags
RoHS marks 1-11 See Test Result Flags
Symbols and Statements 1-9 Results, QC
WEEE mark 1-10 See QC Charts and Data
Reports Results, Test
Calibration 6-17, 6-19 See Test Results
Calibration Data (Curve) 6-21 RoHS Labels
Calibration Data (Cutoff) 6-20 Caution 1-11
Continuous Sample 5-50 Environmental 1-11
Laboratory Information 1-29, 1-30 Routine Maintenance 8-1
List of 1-29 Daily 8-14
Patient 5-47 Effect on Warranty 1-5
Printing a Calibration 6-18 Overview 8-3
Printing System Check 8-50 Utility Assay 8-6
Printing Test Results 5-44 Weekly 8-27
Printing the Reagent Inventory 2-49
Rules for Assigning Tests to Containers 4-8,
QC Chart 7-26 4-9
QC Data 7-26
Rules, Westgard QC
QC Review 7-26
See Westgard QC Rules
Quality Control 7-26
Run Button
Reagent Inventory 2-50
Description 1-20
Result 4-7
Sample Processing 4-5
Result Report Types 5-42
Sample 5-48 RV Cartridge 2-25

Index-10  2014 Beckman Coulter, Inc.


P/N B14251D 9/14
Access 2 Operator’s Guide Index

RV Load Door 2-26 Assignment Rules, Same Sample ID 4-9


RV Waste Bag Button 2-28 Calculating Sample Volumes A-6
RV Waste Bags Elevated Tubes A-3
Button 2-28 Insert Cups A-3
Changing the 2-29 LIS Container Assignment 4-8
Changing the (Flowchart) 2-29 Maintenance A-5
Overview 2-28 Overview A-5
Supply Status 2-3 Pediatric Insert Cup A-3
Verifying Remaining Capacity 4-11 Rack ID Table A-3
Remove Caps 3-10, A-5
RVs
Sample Cups A-3
Button 2-24
Using Insert Cups A-7
Changing the Waste Bag 2-29
Loading 2-25 Sample Errors
Loading (Flowchart) 2-25 Resolving 3-14
Loading Capacity 2-24 Sample IDs
Supplies 2-3 Attaching Bar Code Labels A-6
Supply Overview 2-24 Auto 3-21
Supply Status 2-3 Auto Option 3-35
Verifying Supply 4-11 Bar Code Labels 3-10
Waste Bag 2-28 Editing 3-52
Entering Manually 3-31
Errors 3-7
S
Field on Test Requests Screen 3-22
Safety Multiple Instruments 4-2
Attention Symbol 1-6 Unique for Test Request 3-3
Biohazard Symbol 1-7 Using Auto (Flowchart) 3-34
Electrical Symbol 1-6
Sample Management 3-1
Electrostatic Discharge (ESD) Symbol
Errors 3-7
1-8
Flowchart 3-4
Exclamation Point 1-6
Overview 3-3
Features 1-5
Rack Status 4-25
General Information 1-8
Resolving Sample Errors 3-14
Interlock Switch 1-5
Sample Status 4-27
Laser Symbol 1-8
Moving Parts Symbol 1-7 Sample Manager Screen 3-5
Sharp Objects Symbol 1-7 Sample Processing 4-1
Symbols 1-6 About 4-2
Warnings Preface-16 Flowchart 4-4
Sample Bar Code Labels Monitoring Progress 4-25
Attaching A-6 Order Criteria 4-7
Placement A-7 Pausing 4-5
Rack Status 4-25
Sample Containers
Sample Status 4-27
Access 2 System A-8
Starting 4-5
Assignment Rules, Multiple Instruments
4-9 Stopping 4-6
Assignment Rules, One Instrument 4-8 Test Status 4-27
Work Pending 4-19

 2014 Beckman Coulter, Inc. Index-11


P/N B14251D 9/14
Index Access 2 Operator’s Guide

Sample Progress, Monitoring 4-25 Resolving Errors 3-14


Sample Report Starting to Process 4-5
Continuous 5-50 Stopping in Process 4-6
Test Results 5-48 Viewing Test Result Details 5-25
Sample Status Scanning
Monitoring 4-27 Bar Code Procedure 2-4
Test Request Descriptions 4-27 Reagent Packs 2-36
Sample Tube, Loading Insert Cups A-8 Screen View Button Preface-10
Sample Volumes Screens
Calculating Sufficient A-6 Calibration 6-4
Insufficient 3-6 Calibration Data (Curve) 6-11
Required A-2, A-6 Calibration Data (Cutoff) 6-10
Separator Gel A-6 Calibrator Setup 6-23
Samples Common Elements 1-19
Also See On-Board Samples Compare Charts (QC) 7-21
Adding Test Requests Using Pause Maintenance Requests 8-11, 8-12
Button 3-56 Maintenance Review 8-5
Adding to On-Board Rack 3-49 QC Chart and Data 7-11
Calibration 3-25 QC Setup 7-33
Calibration Test Requests 3-38 Quality Control 7-5
Continuous Report 5-50 Reagent Inventory 2-42
Deleting Test Requests for On-Board Sample Manager 3-5
(Flowchart) 3-53 Supplies 2-6
Deleting Test Requests Using Pause Supplies Required 4-13
Button 3-58 System Check Data 8-48
Deleting Test Requests While On-Board System Checks 8-46
3-54
Test Requests 3-20
Editing Test Requests While On-Board Test Results 5-4
3-52
Work Pending 4-20
Editing Test Requests While On-Board
(Flowchart) 3-51 Scroll Bar 1-24
Evaporation 3-9 Searching the Help Preface-15
Less than 1 mL 3-10 Secured Operations
Loading 3-9 Deleting a Quality Control 7-38
Management 3-3 Deleting QC Point 7-18
Monitoring Status 4-27 Deleting Test Results 5-41
On-Board (Working with) 3-48 See Also Button Preface-10
Patient Test Requests 3-19 Semi-Quantitative
Pausing in Process 4-5 Assay Calibrations 6-2
Placing in Racks 3-9 Curves 6-2
Processing 4-2
Sensors
Processing Order 4-7
Liquid Waste Weight 2-13
Quality Control 3-25
Viewing Information 1-17
Quality Control Test Requests 3-43
Wash Buffer Level 2-10
Rearranging On-Board 3-49
Setup
Removing On-Board 3-49
Calibrators 6-22
Report 5-48
Quality Controls 7-31, 7-34, 7-37

Index-12  2014 Beckman Coulter, Inc.


P/N B14251D 9/14
Access 2 Operator’s Guide Index

Sharp Objects Safety Symbol 1-7 Verifying Unexpired Supply 4-11


Show Me Button Preface-10 Substrate Check, Expected Results 8-56
Sodium Azide Supplies
Safe Handling 1-8 Changing the RV Waste Bag 2-29
Special Clean Changing the Substrate 2-19
Flowchart 8-58 Changing the Wash Buffer Bottle 2-11
Maintenance Routine 8-9 Daily Maintenance 8-18
Overview 8-57 Door 2-26
Required Materials 8-59 Liquid Waste Removal 2-13
Routine Maintenance 8-3 List of Required 4-17
Running 8-59 Loading Reagent Packs 2-33
Running Vitamin B12 8-10 Loading RVs 2-25
Vitamin B12 Assay 8-14 Overriding Conditions 4-16
STAT Access 1-3 Overview 2-3
Reagent Inventory 2-40
Status
Reagent Packs 2-31
Buttons Preface-7
RV Waste Bag 2-28
Calibration Failure Codes 6-14
RVs Overview 2-24
Checking System 8-18
Screen 2-6
Monitoring Racks 4-25
Substrate Overview 2-17
Monitoring Sample Progress 4-25
Unloading Reagent Packs 2-37
Monitoring Samples 4-27
Verifying Sufficient 4-11, 4-16
Monitoring Test 4-27
Supplies Required
Status Line 1-26
Overriding 4-16
Steps
Printing Report 4-17
Optional Preface-8
Report 4-18
Required Preface-8
Screen 4-13
Stop Button Verifying 4-16
Description 1-20
Supply Conditions 4-11
Stopping Sample Processing 4-6
Supply Status 2-4
Substrate 2-19
Support, Technical Assistance Preface-16
Bottle 2-17, 2-19
Bottle in Use 2-17 System Checks
Bottles 2-21, 2-22 Data Screen 8-48
Button 2-17 Expected Results 8-56
Change Window 2-19 Maintenance Requests 8-10
Changing Bottle Restriction 4-3 Maintenance Routines 8-9
Changing the Bottle 2-19 Overview 8-45
Changing the Bottle (Flowchart) 2-18 Printing Reports 8-50
Contamination 2-20 Report 8-51
Partial Bottles 2-19 Required Materials 8-53
Priming 8-23 Results, Viewing 8-50
Priming (Flowchart) 8-22 Routine Maintenance 8-3
Supplies 2-3 Running 8-53
Supply Overview 2-17 Running (Flowchart) 8-52
Supply Status 2-3 Running Weekly 8-44

 2014 Beckman Coulter, Inc. Index-13


P/N B14251D 9/14
Index Access 2 Operator’s Guide

Safe Handling of Solution 8-53 Patient Samples 3-32


Screen 8-46 QC 3-46
Substrate : Washed Ratio 8-56 Test Request, LIS
Substrate Ratio 8-56 See LIS Test Requests
System Command Buttons 1-20 Test Requests
Pause 1-20 Adding and Deleting Restriction 4-3
Run 1-20 Adding to On-Board Samples Using
Stop 1-20 Pause Button 3-56
System Documentation Preface-3 Calibration 3-38, 3-40
System ID, Changing 7-7 Deleting for On-Board Samples 3-54
Deleting for On-Board Samples
System Modes 1-19
(Flowchart) 3-53
Not Ready 1-20
Editing for On-Board Samples
Paused 1-20 (Flowchart) 3-51
Ready 1-19 Editing While Samples On-Board 3-52
Running 1-20 Entering for Patient Manually 3-31
System Navigation 1-26 Entering for Patient Manually
Keyboard Equivalents 1-26 (Flowchart) 3-30
Select and Enter 1-27 Entering Quality Controls 3-45
System Overview 1-3 Maintenance Routines 8-8
System Software, Overview 1-13 Patient 3-19
Processing LIS Patient 3-27
System Status Buttons
Quality Controls 3-43
Descriptions 1-21
Rerunning from Test Results 5-24
Event Log 1-23
Sample Management 3-3
Help 1-23
Screen 3-20
Liquid Waste 1-21
Screen Navigation 3-26
Quality Control 1-22
Represented in Documentation Preface-7 Test Result Flags
RV Waste Bag 1-22 Details 5-25
RVs 1-22 Overriding Supply Conditions 4-16, 4-17
Substrate 1-22 Overview 5-27
Supplies Required 1-23 Test Results 5-1
Supply Conditions 2-3 Applying a Filter 5-11
Supply Status 2-4 Configuring Screen 5-28
Wash Buffer 1-21 Configuring Screen (Flowchart) 5-28
Work Pending 1-23 Copying to Disk 5-36
Copying to Disk or USB Flash Drive
(Flowchart) 5-35
T Defining a Filter 5-19
Technical Support Preface-16 Defining a Filter (Flowchart) 5-18
Temperatures Deleting 5-41
Daily Maintenance 8-18 Deleting (Flowchart) 5-40
Equilibrating Substrate 2-22 Deleting a Filter 5-20
Maintenance Review Screen 8-6 Editing a Filter 5-15
Test Menus Filters 5-9
Calibration 3-41 Finding 5-22
Finding (Flowchart) 5-22

Index-14  2014 Beckman Coulter, Inc.


P/N B14251D 9/14
Access 2 Operator’s Guide Index

Flowchart 5-3 Enabling 8-8


Managing Result Data 5-31 Maintenance Review Screen 8-5
Overview 5-2 Routine Maintenance 8-3
Printing Reports 5-44 Running 8-6
Printing Reports (Flowchart) 5-44 Running Automatically 4-5
Reports 5-42 RV Requirements 8-7
Rerunning a Test 5-24
Reviewing 5-9 V
Reviewing Flags 5-27
Verifying
Screen 5-4
Calibrations for Processing 4-11
Selecting 5-7
Supplies for Processing 4-11
Sending to the LIS 5-32
Viewing Sample Details 5-25 Vessels
Viewing Sample Details (Flowchart) See RVs
5-25 Vitamin B12 Assay
Test Status Daily Maintenance 8-14
Monitoring 4-27 Running Special Clean 8-10
Test Result Descriptions 4-27 Special Clean Routine 8-57
Test Results Screen 5-5 Volumes
Testing, Reflex Calculating Sufficient Sample A-6
See Reflex Tests Dead A-8
Tests Insufficient Sample 3-6
Deleting from Work Pending 4-23 Sample Required A-2, A-6
Monitoring Status 4-27
Reflex Sample Processing 4-3 W
Requesting 3-19 Warnings
Rerunning 5-24 Citranox Handling 8-16
Result Reports 5-42 Contrad Handling 8-16
Work Pending 4-19 Indicators of Harm Preface-16
Tubes Instrument 1-8
Elevated A-3 Sodium Azide 1-8
With Insert Cups A-8 System Check Handling 8-53
With Separator Gel A-3 Wash Buffer Handling 2-10
Warranty
U Required Routine Maintenance 1-5
Unloading System 1-5
Racks 3-12 Wash Buffer
Reagent Packs 2-37 Bottle 2-10, 2-12
Unwashed Check, Expected Results 8-56 Button 2-10
Changing the Bottle 2-11, 2-12
USB Flash Drives
Changing the Bottle (Flowchart) 2-11
See Flash Drives
Contamination 2-11
User Interface (UI) Software 1-13
Mixing 2-11
Utility Assay Reservoir 2-10, 2-12
After Stopping Sample Processing 4-6 Reservoir Overflow 2-12
Disabling 8-8 Safe Handling 2-10

 2014 Beckman Coulter, Inc. Index-15


P/N B14251D 9/14
Index Access 2 Operator’s Guide

Supplies 2-3 System Check Portion 8-44


Supplies Overview 2-10 System Checks 8-45
Supply Status 2-3 Westgard QC Rules
Verifying Supply 4-11 Adding for Quality Controls 7-34
Wash Buffer Valve Assembly 2-12 Description 7-9
Wash Efficiency, Expected Results 8-56 Editing for Quality Controls 7-37
Washed Check, Expected Results 8-56 Points Violating Rules 7-13
Quality Control Overview 7-3
Waste Containers
Reviewing Charts and Data 7-9
Daily Maintenance 8-18
Rules Applied 7-14
Liquid Waste Bottle 2-13
Setting Up Quality Controls 7-31
RV Waste Bag 2-28
Supplies 2-3 Window Button Bar in Help Preface-12

Waste Filter Bottle Window View Button Preface-10


Checking for Fluid 8-31 Windows
Checking for Fluid (Flowchart) 8-31 Add Calibrator 6-26
Waste Handling Add Control (QC) 7-35
Changing the RV Bag 2-29 Change Substrate 2-19
Liquid 2-13, 2-15 Common 1-27
RV Waste Bag 2-28 Configure Screen (Test Results) 5-29
Copy to Disk (Test Results) 5-37
Waste, Liquid
Edit Filter (Test Results) 5-15
See Liquid Waste
Filter (Calibration) 6-6
Weekly Maintenance
Filter (QC Chart and Data) 7-16
Checking for Fluid in the Waste Filter
Filter (Quality Controls) 7-7
Bottle (Flowchart) 8-31
Filter (Reagent Inventory) 2-46
Checking for Waste Fluid 8-31
Filter (Test Results) 5-12
Cleaning Aspirate Probes 8-38
Filter (Work Pending) 4-22
Cleaning the Aspirate Probes with
Contrad 70 Cleaning Solution Find (Test Result) 5-23
(Flowchart) 8-41 Help Preface-11
Cleaning the Aspirate Probes with Help Topics Preface-13
Distilled Water (Flowchart) 8-43 Help Topics (Find View) Preface-15
Cleaning the Instrument Exterior 8-30 Load Reagent Pack 2-34
Cleaning the Primary Probe Exterior Overview 1-27
(Flowchart) 8-32 Print (QC Chart and Data) 7-28
Daily Maintenance Portion 8-44 Print (Test Result Reports) 5-46
Flowchart 8-28 Request Calibration 3-40
Inspecting the Liquid Waste Bottle 8-30 Request Maintenance 8-9
Overview 8-27 Request QC 3-45
Precleaning the Aspirate Probes Sample Details (Test Results) 5-26
(Flowchart) 8-39 Send to LIS (Test Results) 5-33
Primary Probe Inspecting and Cleaning Specify a Date Range (Test Results
8-32 Filter) 5-20
Replacing the Aspirate Probes 8-35
Work Pending
Replacing the Aspirate Probes
Applying a Filter 4-22
(Flowchart) 8-34
Deleting Tests 4-23
Required Materials 8-29
Overview 4-19

Index-16  2014 Beckman Coulter, Inc.


P/N B14251D 9/14
Access 2 Operator’s Guide Index

Printing Report 4-24


Report 4-24
Screen 4-20
Workpool, LIS
See LIS Workpool
Worksheets
Quality Control 7-42, 7-43

 2014 Beckman Coulter, Inc. Index-17


P/N B14251D 9/14
Index Access 2 Operator’s Guide

Index-18  2014 Beckman Coulter, Inc.


Printed in U.S.A. P/N B14251D 9/14

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