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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
page of the
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 O
Ov
verview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
1.1 System Overview
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


Buffer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-10

2.3 Liquid Waste


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


Packs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-31

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

3 Samp
Sample
le Mana
Manage
geme
ment
nt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
3.1 Sample Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3

3.2 Patient Test Requests


Requests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-19

 2014 Beckman Coulter, Inc. iii 


P/N
P/N B1425
B14251D
1D 9/14 
9/14 
Table of Contents Access 2 Operator’s Guide  

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 Samp
Sample
le Pro
Process
cessin
ing
g . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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
Monitoring Sample
Sample Progress
Progress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-25

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


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

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

5.3 Managing Test Results.


Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31

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

6 Assa
Assay
y Cal
Calib
ibra
rati
tio
ons  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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


Calibrators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-22

7 Qualit
lity Con
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


Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-31

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

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

8 Rout
Routin
ine
e Main
Mainte
tena
nanc
nce
e  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
8.1 Routine Maintenan
Maintenance
ce . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3

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

iv   2014 Beckman Coulter, Inc.


P/N
P/N B14251
B14251D
D 9/14 
9/14 
Access 2 Operator’s Guide Table of Contents  

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

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

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

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

A Rack
Rackss and
and Samp
Sample
le Con
Conta
tain
iner
erss . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-1
A.1 Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2

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

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

 2014 Beckman Coulter, Inc. v 


P/N
P/N B1425
B14251D
1D 9/14 
9/14 
List of Figures and Tables Access 2 Operator’s Guide  

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
Books (or Pages)
Pages) . . . . . . . . . . . . . . . . . . . . . . Preface-5
Preface-5
Table 4  Help System Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Preface-9
Tabl
Tablee 5 Help
Help Butto
Button
n Desc
Descri
ripti
ption
onss . . . . . . . . . . . . . . . . . . . . . . . . . Pref
Prefac
ace-
e-10
10
Figu
Figure
re 6 Help
Help Win
Windo
dow
w Butto
Button
n Bar
Bar . . . . . . . . . . . . . . . . . . . . . . . . . Prefac
Preface-1
e-12
2
Tabl
Tablee 7 Help
Help Windo
Window
w But
Button
ton Bar Descr
Descript
iptio
ions
ns . . . . . . . . . . . . . . Prefac
Preface-
e-12
12
Figu
Figure
re 8 Help
Help Topi
Topics
cs Win
Windo
dow
w (Con
(Conten
tents
ts View
View)) . . . . . . . . . . . . . . Prefa
Preface
ce-1
-13
3
Tabl
Tablee 9 Help
Help Top
Topic
icss Wind
Window
ow Descr
Descrip
iptio
tions.
ns. . . . . . . . . . . . . . . . . . Pref
Prefac
ace-
e-14
14
Figure
Figure 10 Help Topics
Topics Wind
Window
ow (Find
(Find View)
View) . . . . . . . . . . . . . . . . . . Preface-
Preface-15
15
Table
Table 11
11 Notes,
Notes, Cauti
Cautions
ons,, and
and Warni
Warnings.
ngs. . . . . . . . . . . . . . . . . . . . . Preface-
Preface-16
16

Figure
Figure 1-1 Attention
Attention Safety
Safety Symbol.
Symbol. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Figure
Figure 1-2
1-2 Electric
Electrical
al Safety
Safety Symbo
Symboll . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Figure
Figure 1-3
1-3 Biohaz
Biohazard
ard Symb
Symbols.
ols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Figure
Figure 1-4
1-4 Sharp
Sharp Object
Objectss Symbol
Symbol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Figure
Figure 1-5
1-5 Moving
Moving Parts
Parts Symb
Symbol
ol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7
Figure
Figure 1-6 Electrostatic
Electrostatic Discharge
Discharge Symbol
Symbol . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Figure
Figure 1-7
1-7 Laser
Laser Symbo
Symboll . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
Figure
Figure 1-8 Canadian Standards
Standards Associatio
Association
n Symbol
Symbol . . . . . . . . . . . . . . . . . . . 1-9
Figure
Figure 1-9 CE Mark . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Figure
Figure 1-10 C-Tick Mark
Mark . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
Figure
Figure 1-11 WEEE Mark . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Figure
Figure 1-12 EU Battery Directive
Directive Symbol.
Symbol. . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Figure
Figure 1-13 RoHS Caution
Caution Logo
Logo . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
Figure
Figure 1-14 RoHS Environ
Environmental
mental Logo
Logo . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11

vi   2014 Beckman Coulter, Inc.


P/N
P/N B14251
B14251D
D 9/14 
9/14 
Access 2 Operator’s Guide List of Figures and Tables  

Figure
Figure 1-15 Main Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Table 1-16
1-16 Main Menu
Menu Options
Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Figure
Figure 1-17 Main Menu Work Flow.
Flow. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18
Figure
Figure 1-18 Common Access 2 System
System Screen Elements
Elements . . . . . . . . . . . . . . . 1-19
1-19
Table 1-19
1-19 System Modes
Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19
Table 1-20
1-20 System Command
Command Buttons
Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20
1-20
Table 1-21
1-21 System Status
Status Buttons.
Buttons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-21
Figure
Figure 1-22 Back and Menu Tabs.
Tabs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-24
1-24
Table 1-23
1-23 Function
Function Button
Button Examples
Examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-25
1-25
Table 1-24
1-24 Information
Information Field
Field Examples
Examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-26
Table 1-25
1-25 Keyboard
Keyboard Equivalent
Equivalentss . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27
1-27
Figure
Figure 1-26 OK/Cancel/Help
OK/Cancel/Help Window
Window Example
Example . . . . . . . . . . . . . . . . . . . . . . 1-28
Figure
Figure 1-27 Report Headers
Headers and Standard
Standard Text
Text . . . . . . . . . . . . . . . . . . . . . . . 1-30

Figure
Figure 2-1
2-1 Suppli
Supplies
es Screen
Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Table
Table 2-2
2-2 Suppli
Supplies
es Screen
Screen Descrip
Descriptio
tions
ns . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Figure
Figure 2-3 Changing
Changing the Wash Buffer
Buffer Bottle
Bottle Flowchar
Flowchartt . . . . . . . . . . . . . . . 2-11
Figure
Figure 2-4
2-4 Changi
Changing
ng the
the Wash
Wash Buffer
Buffer Bottl
Bottlee . . . . . . . . . . . . . . . . . . . . . . . . 2-12
2-12
Figure
Figure 2-5 Changing
Changing the Liquid Waste Bottle
Bottle Flowchart.
Flowchart. . . . . . . . . . . . . . . 2-14
Figure
Figure 2-6
2-6 Liquid
Liquid Waste
Waste Bott
Bottle
le . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-16
2-16
Figure
Figure 2-7 Changing
Changing the Substrate
Substrate Bottle Flowchart
Flowchart . . . . . . . . . . . . . . . . . . 2-18
Figure
Figure 2-8
2-8 Change
Change Subs
Substrat
tratee Window
Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-19
2-19
Table
Table 2-9
2-9 Change
Change Subs
Substra
trate
te Window
Window Descrip
Description
tions.
s. . . . . . . . . . . . . . . . . . . 2-19
2-19
Figure
Figure 2-10 Substrate
Substrate Bottles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-21
Figure
Figure 2-11 Substrate
Substrate Supply
Supply Cap Configurati
Configurations
ons . . . . . . . . . . . . . . . . . . . . . 2-22
Figure
Figure 2-12 Finger Tighten
Tighten Substrate
Substrate Supply
Supply Cap Fittings
Fittings . . . . . . . . . . . . . . 2-22
Figure
Figure 2-13 Loading
Loading RVs Flowchart
Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25
2-25
Figure
Figure 2-14 Inserting
Inserting an RV Cartridge
Cartridge into
into the RV Supply
Supply Area . . . . . . . . . 2-26
Figure
Figure 2-15 Changing
Changing the RV Waste
Waste Bag Flowchart
Flowchart . . . . . . . . . . . . . . . . . . . 2-29
2-29
Figure
Figure 2-16 Loading
Loading a Reagent Pack Flowchart.
Flowchart. . . . . . . . . . . . . . . . . . . . . . . 2-32
Figure
Figure 2-17 Load Reagent
Reagent Pack
Pack Window
Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-34
2-34
Table 2-18
2-18 Load Reagent
Reagent Pack
Pack Window
Window Descriptions
Descriptions . . . . . . . . . . . . . . . . . 2-34
2-34
Figure 2-19
2-19 Loading
Loading a Reagent Pack
Pack into the Reagent
Reagent Carousel
Carousel . . . . . . . . . . 2-35
2-35
Figure
Figure 2-20 Scanning
Scanning a Reagent
Reagent Pack Bar Code
Code with the Bar Code
Code Wand . . 2-36
Figure 2-21
2-21 Unloading
Unloading a Reagent
Reagent Pack Flowchart
Flowchart . . . . . . . . . . . . . . . . . . . . . 2-37
Figure
Figure 2-22 Reagent Invento
Inventory
ry Screen
Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-42
2-42

 2014 Beckman Coulter, Inc. vii 


P/N
P/N B1425
B14251D
1D 9/14 
9/14 
List of Figures and Tables Access 2 Operator’s Guide  

Table 2-23
2-23 Reagent
Reagent Inventory
Inventory Screen
Screen Description
Descriptionss . . . . . . . . . . . . . . . . . . . 2-43
Figure
Figure 2-24 Filter (Reagent
(Reagent Inventory)
Inventory) Window
Window . . . . . . . . . . . . . . . . . . . . . . 2-46
Table 2-25
2-25 Filter (Reagent
(Reagent Inventory)
Inventory) Window
Window Descriptions
Descriptions . . . . . . . . . . . 2-46
Figure
Figure 2-26 Deleting a Reagent Pack
Pack Flowchart
Flowchart . . . . . . . . . . . . . . . . . . . . . . 2-48
Figure
Figure 2-27 Reagent Inventory
Inventory Report
Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-50

Figure
Figure 3-1
3-1 Sample
Sample Manag
Managemen
ementt Flowch
Flowchart
art . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Figure
Figure 3-2
3-2 Sample
Sample Manag
Manager
er Screen
Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Table
Table 3-3
3-3 Sample
Sample Mana
Manager
ger Screen
Screen Descr
Descript
iption
ionss . . . . . . . . . . . . . . . . . . . . . 3-6
Figure
Figure 3-4 Loadin
Loading
g Racks
Racks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-12
Table
Table 3-5
3-5 Rack Status
Status . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
Figure
Figure 3-6
3-6 Test Requ
Requests
ests Screen
Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-20
Table
Table 3-7
3-7 Test
Test Reques
Requests
ts Scree
Screen
n Descrip
Description
tionss . . . . . . . . . . . . . . . . . . . . . . . 3-20
Figure
Figure 3-8 Processing
Processing LIS
LIS Test Requests Flowchart
Flowchart . . . . . . . . . . . . . . . . . . 3-27
Figure
Figure 3-9 Entering
Entering Patient
Patient Test Requests Manually Flowchart
Flowchart . . . . . . . . . 3-30
Figure
Figure 3-10 Test Menu (Patient
(Patient Samples)
Samples) . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-32
Table 3-11
3-11 Test Menu (Patient
(Patient Samples)
Samples) Descriptions.
Descriptions. . . . . . . . . . . . . . . . . 3-32
Figure
Figure 3-12 Using Auto
Auto Sample
Sample ID Flowchart
Flowchart . . . . . . . . . . . . . . . . . . . . . . . 3-34
Figure
Figure 3-13 Using Batch
Batch Request
Request Flowchart
Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . 3-36
Figure
Figure 3-14 Entering
Entering Calibration
Calibration Test Requests Flowcha
Flowchart
rt . . . . . . . . . . . . . . 3-39
Figure
Figure 3-15 Request
Request Calibration
Calibration Window
Window . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-40
Figure
Figure 3-16 Test Menu (Calibration)
(Calibration) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-41
Table 3-17
3-17 Test Menu (Calibration)
(Calibration) Descriptio
Descriptions
ns . . . . . . . . . . . . . . . . . . . . 3-41
Figure
Figure 3-18 Entering
Entering Quality Control
Control Test
Test Requests Flowchar
Flowchartt . . . . . . . . . . 3-44
Figure
Figure 3-19 Request
Request QC Window
Window . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-45
Figure
Figure 3-20 Test Menu (QC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-46
Table 3-21
3-21 Test Menu (QC) Descriptio
Descriptions.
ns. . . . . . . . . . . . . . . . . . . . . . . . . . . 3-46
Figure
Figure 3-22 Adding,
Adding, Removing, and Rearranging
Rearranging On-Board
On-Board Samples
Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-49
Figure
Figure 3-23 Editing Test
Test Requests
Requests for On-Board
On-Board Samples
Samples Flowchart.
Flowchart. . . . . . 3-51
Figure
Figure 3-24 Deleting
Deleting Test Requests
Requests for On-Board
On-Board Samples
Samples Flowchart.
Flowchart. . . . . 3-53
Figure
Figure 3-25 Adding Test
Test Requests to On-Board
On-Board Samples
Samples Using the
the
Pause Button Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-55
Figure
Figure 3-26 Deleting
Deleting Test Requests from On-Board
On-Board Samples
Samples Using the
Pause Button Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-57

viii   2014 Beckman Coulter, Inc.


P/N
P/N B14251
B14251D
D 9/14 
9/14 
Access 2 Operator’s Guide List of Figures and Tables  

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

 2014 Beckman Coulter, Inc. ix 


P/N B14251D 9/14 
List of Figures and Tables Access 2 Operator’s Guide  

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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P/N B14251D 9/14 
Access 2 Operator’s Guide List of Figures and Tables  

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

 2014 Beckman Coulter, Inc. xi 


P/N B14251D 9/14 
List of Figures and Tables Access 2 Operator’s Guide  

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

xii   2014 Beckman Coulter, Inc.


P/N B14251D 9/14 
Access 2 Operator’s Guide Preface  

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

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

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

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

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

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

 2014 Beckman Coulter, Inc. Preface-1


P/N B14251D 9/14 
Preface Access 2 Operator’s Guide  

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
• How to view the onboard and inventory rack lists
Management
• 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
• How to run the System Check and Special Clean
Maintenance
routines

• How to manage or run the Utility Assay

Table 1 Operator’s Guide Chapters 

Preface-2   2014 Beckman Coulter, Inc.


P/N B14251D 9/14 
Access 2 Operator’s Guide Preface  

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 

 2014 Beckman Coulter, Inc. Preface-3 


P/N B14251D 9/14 
Preface Access 2 Operator’s Guide  

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 rea der 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) 

Preface-4   2014 Beckman Coulter, Inc.


P/N B14251D 9/14 
Access 2 Operator’s Guide Preface  

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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Preface Access 2 Operator’s Guide  

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 t he 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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Access 2 Operator’s Guide 1.3: Software Overview  

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  T est Request
Sample Manager F5 Request QC
F4  Ma intenance 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  Calibr ator Setup
F5
F6  Delete
F7  Print
F1 Filter
F2 Find
F3  Re run Test
F4  Sa mple 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  Dig ital Devices
F3 Volume Checks
F7  Reagent Inventory Reagent Pack F4  Luminometer
F4  Devi ce Diagnostics
F5 Delete Pack F5  Ultrasonics
F7  Print F6  Exerciser
F8  Filter F7  Calibrate
Incubator Belt
Diagnostics
F7
F1  LI S Setup
F3  Loopback
  Check
F5 LIS F4 Query for
F6 Copy to Disk Test Requests
F7  Diagnost ic Reports F6 Copy to Disk
F8 Clear Screen

F1  S ystem Revisions


F1 Filter F2 Bar Code
F2 Review Chart Reader Setup
and Data F1 System Setup F3  S et Workgroup
Quality Control
F3  Co mpare Charts   Date/Time
F4
F4  De lete Comparison F5  P assword Setup
F5  Q C Setup F7  Repor ts 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  S cheduled Backup
F5  Refl ex Tests
F2 Immediate Backup
F6 LIS
F3  E ject Tape
F7 PC Admin
F4  Restore
F8 About Access 2
F5  Aut o-Delete Setup
F8 Shut Down PC

0863D.wmf 

Figure 1-17 Main Menu Work Flow 

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Access 2 Operator’s Guide 1.3: Software Overview  

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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Access 2 Operator’s Guide 1.3: Software Overview  

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
buffer bottle to continue processing
For more information about how to
tests.
change wash buffer, see Section 2.2:
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
continue processing tests.
For more information about how to
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
opportunity.
For more information about how to load
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
the waste bag. Change the RV waste
For more information about how
bag at your next opportunity.
change the RV waste bag, see
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
review this result as soon as possible.
For information about quality controls,
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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1.3: Software Overview Access 2 Operator’s Guide  

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 Ba ck tab
Menu Tabs to display the previous screen. Select the Menu tab to displa y 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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Access 2 Operator’s Guide 1.3: Software Overview  

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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1.3: Software Overview Access 2 Operator’s Guide  

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 activit y 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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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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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 l imits 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 pr event 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 posit ion and the system updates
the Supplies screen with the current RV inventory.

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3.1: Sample Management Access 2 Operator’s Guide  

• 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 res ults.

• 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 a nd 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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Access 2 Operator’s Guide 3.1: Sample Management  

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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3.1: Sample Management Access 2 Operator’s Guide  

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 t hat 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 sa mple 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 l ot 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 l ot 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 patie nt 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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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 s ystem 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 s ample, 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 repli cates
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 Re quest 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 automati cally 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 characte rs until
you reach the end of the field.

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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 a nd 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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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
NOTES
Manually
• 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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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


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)


(Calibration) Descriptions 
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
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 Appendi


Appendix
x A: Racks
Racks
and Sample Containers in this manual. For assay-specific sample volume
information, see the reagent instructions for use.

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7 Load the rack (see


(see the Loading Racks procedure in this chapter).

 (Optional) To request additional calibration sets, repeat ste


step 2 through step
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


Section 4.1: Sample
Sample
Processing.
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 availa ble 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 t est 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
Working with On-Board Samples.
Samples.

For information about how to review quality control data, see Section
Section 7.2: Reviewing
Reviewing
Quality Control Charts and Data.
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


Control Test Requests Flowchart 
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


QC Window 
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 f or 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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Access 2 Operator’s Guide 3.4: Quality Control Test Requests  

 (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 Appendi


Appendix
x A: Racks
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


Section 4: Sample
Sample
Processing.
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 ac tivity 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 s cans the rack(s) for changes. If you added sampl es
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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4.1: Sample Processing Access 2 Operator’s Guide  

LIS Request When the system receives an L IS 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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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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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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4.2: Supply and Calibration Conditions Access 2 Operator’s Guide  

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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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 thi s 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 thi s 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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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


overridden expired supplies or
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 thi s 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).
4-7).

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

Tests Requested 36
Tests to Run 0

Required Supply Lot Number Status


C ha n g e Substrate 1 0 3 1 87 Expired
C h an g e R V W a st e B a g
Empty Liquid Waste
1 Cartridge R Vs
C h a n ge PSA-Hyb 0 0 81 4 1 Pack Expired
Recalibrate PSA-Hy b 0 0 81 4 1 Calibration Expired

Page 1 of 1
Technologist ___________ _____________ Printed 0 4/04/11 03:16 PM

0823D.bmp

Figure 4-7 Supplies Required


Required Report 
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, a nd the Work Pending button turns yellow. You must
Work Pending
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 Configuratio


Configuration
n in the
 Reference Manual.

For information about rerunning tests with fatally flagged results, see Chapter
Chapter 5: Test
Results.
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


Pending Screen
Screen

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

Table 4-9 Work Pending


Pending Screen
Screen Descri
Descriptions
ptions

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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 fi lter 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.
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
Chapter 3: Sample
Sample
Management.
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.
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.
section.

Table 4-9 Work Pending Screen Descriptions (continued)

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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 


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.
Manual Rerun

• 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  

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 s elected 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 re sult, 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 te st 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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5.1: Test Results Access 2 Operator’s Guide  

 (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 R esults 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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5.2: Reviewing Test Results Access 2 Operator’s Guide  

You can also edit the laboratory-defined filter parameters to display different test
results, or you can use a system-defined filter as a basis for creating a new filter. For
example, you can select the system-defined All Patient Samples (Last 30 Days)
filter, change the parameters, and save the filter with a new name.

When you change any of the parameters of a filter, you can either save the changes as
a new filter or apply the changes without saving them. If you do not save the changes,
the system retains the unnamed filter only until you apply a different one. You would
have to redefine the filter to use it again.

The last filter you apply becomes the default filter for the next time you display the
Test Results screen. The Access 2 system automatically uses that default filter until
you apply a new one or until the system is rebooted.

A sort order determines the order test results are listed in, and you can include both
primary and secondary sort orders in a filter. For example, you can sort test results by
Sample ID, then by Completion Time in ascending order.

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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  

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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Access 2 Operator’s Guide 5.2: Reviewing Test Results  

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, i f 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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5.2: Reviewing Test Results Access 2 Operator’s Guide  

 (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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5.2: Reviewing Test Results Access 2 Operator’s Guide  

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 associ ated 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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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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P/N B14251D 9/14 
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 a re 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
Continuous automatically print test result
printing from 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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P/N B14251D 9/14 
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 6.2: Reviewing Calibration Data  

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
NOTES
Active
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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P/N B14251D 9/14 
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
Ac cess 2 Immunoassay Syste m 101 - 555 - 2323 ext. 109
S/N 501240 Jane Smith

T e s t: TropI Start Date: 10/01/11


Control: CardiacB E nd D a t e : 10/07/11
Contr ol Lot: 1 2 3 4 5 6 7B Points: 7
Expiration: 11/11/11 Me a n : 0.305 4
Stated Mean: 0.300 0 SD: 0.037 0
Stated SD: 0 .1 0 0 0 %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 . 0 26 10/01/11 08:39 PM 1 3 0 16 1 N/A
0.299 ng/mL - 0 .0 1 5 1 0 /0 2 / 1 1 0 8 :3 5 P M 13 0 1 61 N/ A
10.418 ng
ng/mL 1 0 1. 1 80 10/03/11 08 08:25 PM PM *1**3* Conta minate d X 13 0 1 6 1 N/ A
 sample- retest
with new sample
0.294 n g/ mL - 0 .0 6 2 10/03/11 0 9 :1 0 P M 1 3 0 16 1 N/ A
0.247 n g/ mL - 0 .5 2 6 10/04/11 0 8 :3 7 P M 1 3 0 16 1 N/ A
0.292 n g/ mL 0. 0 7 6 10/05/11 0 8 :5 2 P M 1 3 01 6 1 N/A
0.361 n g/ mL 0. 6 1 0 10/06/11 0 3 :1 2 P M 1 4 42 1 9 N/A
0.588 n g/ mL 2. 8 8 2 10/07/11 0 4 :1 8 P M *1* Sample left in X 14 4 2 19 N/ A
instrument too
long- retest
0.342 ng/mL 0. 4 2 0 10/07/11 04:56 PM 1 4 4 21 9 N/A

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

Page 1 of 1
Technologist __
___________ ____________________ ______________ Printed 10
10/10/11 05
05:32 PM
PM

0773E.bmp

Figure 7-16 QC Data Report 

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P/N
P/N B1425
B14251D
1D 9/14 
9/14 
7.3: Quality Control Reports Access 2 Operator’s Guide  

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0774E.bmp.

Figure 7-17 QC Chart


Chart Report 

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P/N
P/N B14251
B14251D
D 9/14 
9/14 
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
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


Rules topic in Section 7.2:
Reviewing Quality Control Charts and Data.
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


Quality Controls Flowchart 
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


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 


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.
Setup

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
7-21 Add Control
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
Rules topic in Section 7.2: Reviewing Quality Control Charts and
Data.
Data.

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

Table 7-22 Add Control Window Descriptions 


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.


Pipet
Pipettor
tor F4

Table 7-22 Add Control Window Descriptions


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
Chapter 4: System
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).
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 instruct ions 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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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
(see Figure 8-26).
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 t o run the Utili ty Assay. You
You run the Utilit y Assay as requested by
Technical Support or as required for troubleshooting. The Utility Assay cleans the
main pipettor, aspirate, and dispense probes (see
( see the Running the Utility Assay
procedure in this section).
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
Section 5.6: Analog
Analog
and Digital Device Diagnostics in the Reference Manual). You
You can also print the
Temperature Report from the Diagnostics menu.
For an example, see Section 5.10: Diagnostic
Diagnostic Reports
Reports in the Reference Manual.

Table 8-2 Maintenance Review Screen Descriptions


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
( see the Enabling/Disabling the Utility Assay

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Access 2 Operator’s Guide 8.1: Routine Maintenance  

procedure in this section).


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
Mainte
Maintenan
nance Review F6 (see
ce Review  (see Figure 8-1).
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 Util ity 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
 (see Figure 8-1).
8-1).

2 Select Disable
Disable Utility Assay F6.

 To restart the timer for the Utility Assay, select Enable


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
(see Figure 8-3).
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 


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
( see the Running the Daily
Clean System Routine procedure in this section).
section).

Table 8-4 Request Maintenance Window


Window Descriptions
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
processing the
Vitamin
itamin B12 assay.

For more information about running the Special Clean


routine, see Section
Section 8.5: Special
Special Clean.
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
( 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:
5.11: Individual Checks in the Reference
Individual System Checks in
 Manual.

Table 8-4
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
(see Figure 8-5).
8-5 ).

NOTE

The completion time is updated when Run is selected in step


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


Sample Management
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 c ompromise 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 sele ct Done F1.

For more information on unloading a rack, see Section


Section 3.1: Sample
Sample
Management.
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.
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


Requests Screen 
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 


Descriptions 

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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
Monitoring Sample
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
 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 Configuratio
Configuration
n 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


(see Figure 8-1).
8-1).
Review F6

Table 8-6 Maintenance Requests Screen Descriptions


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, w hich 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
No For information on system backups,
Successful? 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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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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P/N B14251D 9/14 
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 c ompromise 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 eac h 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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P/N B14251D 9/14 
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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P/N B14251D 9/14 
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, w hich 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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P/N B14251D 9/14 
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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P/N B14251D 9/14 
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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P/N B14251D 9/14 
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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P/N B14251D 9/14 
A.1: Racks Access 2 Operator’s Guide  

Attaching To be sure that the internal bar code rea der can accurately read the rac k 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.

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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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
Required Materials 8-16
Contrad Cleaning Solution
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
Comparing QC Charts 7-24
Failure Codes, Calibration 6-14
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  

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

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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
Patient 3-19
System Software, Overview 1-13
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
Test Result Flags
Represented in Documentation Preface-7
Details 5-25
RV Waste Bag 1-22
Overriding Supply Conditions 4-16, 4-17
RVs 1-22
Overview 5-27
Substrate 1-22
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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