m560_man. operacion.pdf

8/12/2019 M560_MAN. OPERACION.pdf

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DECis a trademark of Digital Equipment Corporation.

664 Fast 4is a trademark of Bayer Corporation.

IBMis a trademark of International Business Machine Corporation.

No part of this manual or the products that it describes may bereproduced by any means, or in any form, without prior writtenconsent from Bayer Corporation.

Printed in the U.S.A.

The information in this manual was correct at the time of printing.However, Bayer Corporation continues to improve products andreserves the right to change specifications, equipment, andmaintenance procedures at any time without prior notice.

All Rights Reserved


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Contents-1

Contents Page

Preface Preface-1

1 Using This Manual 1-1

About This Section 1-3

Who Should Read This Manual 1-3

How to Find the Information 1-4

Conventions Used in This Manual 1-5

Special Terms Used in This Manual 1-6

Labels Used on the System 1-7

Other Express Plus Documents 1-8

2 Understanding the Express Plus 2-1


Intended Use 2-3

System Features 2-4

Bar Code Features 2-4

Reagent Carryover Reduction Feature 2-5

Dilution and Rerun Features 2-5

Data Management Features 2-6

Express Plus Subsystems: Principles of Operation 2-8

Sample and Reagent Transport Subsystem 2-9

Fluid Subsystem 2-12

Cuvette Subsystem 2-17

Photometer Subsystem 2-20

Communications Subsystem 2-22


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Contents-2

Contents(Continued) Page

Express Plus Subsystems: Principles of Operation (Continued)

User Interface Subsystem 2-24

Moving Through the Software 2-32

Screen Zones 2-34

Express Plus Programs 2-35

Operational Sequence 2-37

3 Understanding the System Calculations 3-1


Calculating Absorbance 3-6

Blanks and Zero Calibrators 3-8

Polychromatics 3-8

Monochromatics 3-9

Common Bichromatics 3-9

Sample Blanking 3-9

Monochromatic Absorbance Check 3-10

Data Selection 3-11

Substrate Depletion 3-11

Outlier Rejection 3-11

Calculating Response Values 3-13

Kinetic Test Type 3-13

Endpoint Test Type 3-15

Two-Point Test Type 3-15


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Contents-4


4 Understanding the Express Plus Programs 4-1


Using the Main Menu Programs 4-3

Worklist Program 4-7

Patient Results Program 4-11

Calibration Data Program 4-14

Q.C. Statistics Program 4-21

Definitions Program 4-32

Options Program 4-49

Diagnostics/Maintenance Program 4-57

Load Alternate Program 4-64

5 Setting Up the Express Plus 5-1


Setting or Modifying Options 5-5

Selecting Definitions Program Options 5-11

Defining, Modifying, or Erasing Test Definitions 5-12

Defining Test Parameters 5-14

Defining Profiles 5-24

Defining Control Values 5-26

Defining Controls 5-27

Defining Calibrators 5-30

Defining Blanks 5-33


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Contents-5


5 Setting Up the Express Plus(Continued)

Backing Up the Data Files 5-37

Restoring the Data Files 5-41

6 Operating the Express Plus 6-1


Operating Summary 6-5

Operating the Express Plus 6-7

Starting Up 6-11

Priming the System 6-13

Preparing the Worklist 6-14

Erasing a Stored Worklist 6-14

Reviewing Calibration Status 6-15

Scheduling Samples in the Worklist 6-16

Entering Patient Demographics 6-20

Modifying the Worklist 6-21

Printing the Worklist 6-22

Loading the Sample Trays 6-23

Loading the Reagent Tray 6-24

Verifying System Conditions 6-25

Verifying Reagent Loading 6-26

Starting the Run 6-29

Installing the Next Sample Tray(s) 6-30

Loading Stats or Single Samples During a Run 6-31

Reviewing Scheduled Samples 6-33


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Contents-6

Contents (Continued) Page

6 Operating the Express Plus (Continued)

Automatically Rerunning and Diluting Samples 6-34

Manually Rerunning and Diluting Samples 6-36

Correcting Errors During a Run 6-37

Reviewing Run-time Results 6-39

Using the Patient Results Program 6-43

Reviewing Sample Results 6-43

Editing Sample Results 6-45

Printing Sample Results 6-47

Shutting Down 6-51

7 Using the Calibration Data and Q.C. Statistics Programs 7-1


Defining Calibration Parameters 7-7

Defining Calibration Concentrations 7-8

Reviewing Calibration Status 7-10

Automatically Normalizing or Reblanking a Stored Curve 7-13

Managing Curve Data 7-14

Waiving an Expired Curve 7-16

Reviewing Run-Time Error Flags for Calibrators 7-17

Selecting Controls and Control Rules 7-21

Viewing or Modifying QCSystems Codes 7-24

Viewing Q.C. Data 7-26


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Contents-7


7 Using the Calibration Data and Q.C. Statistics Programs(Continued)

Viewing Q.C. Plots 7-28

Modifying Q.C. Data 7-30

Viewing Summary Statistics 7-33

Printing Q.C. Data Reports 7-35

Printing a QCSystems Report 7-39

Reviewing Run-time Error Flags for Controls 7-41

Deleting Data from the Q.C. Database 7-44

8 Using the HELP and STATUS Programs 8-1


Using the Help Program 8-3

Using the Status Program 8-5

Using System Details 8-8

Using Reagent Status 8-11

Using Sample Status 8-14

Using Pending Status 8-17

Using Communications Status 8-20

9 Maintaining the Express Plus 9-1


Performing Preventive Maintenance Tasks 9-4

Understanding the Hazards 9-5

Cleaning the System Cabinet and Screen 9-6

Cleaning the Sample Integrity Tray 9-7

Cleaning the Probe Tip 9-8


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Contents-8


Performing Preventive Maintenance Tasks (Continued)

Performing a Precision Check 9-9

Cleaning the System Tubing 9-12

Cleaning the Fan Filters 9-14

Replacing the Wash and Waste Pump Tubing 9-16

Replacing the In-Line Filter 9-19

Cleaning the Digital Diluter Syringe 9-21

Performing Corrective Maintenance Tasks 9-26

Replacing the Lamp 9-27

Replacing the Fuses 9-31

Replacing and Calibrating the Probe Tip 9-32

Replacing the Digital Diluter Syringe 9-37

Filling the Water Bath 9-43

Replacing Printer Paper 9-45

Backing Up Data, System Calibration, and Program Files 9-46

Restoring Data or System Calibration Files 9-50

Resetting the System 9-52

10 Troubleshooting the Express Plus 10-1


What to Do in Case of Trouble 10-4

Finding Status and Error Messages 10-5

Using the Status Program to Troubleshoot 10-11

Correcting System Status and System Detail Errors 10-13


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Contents-9


10 Troubleshooting the Express Plus (Continued)

Correcting Reagent Status Errors 10-44

Reagent Status Calibration Failures 10-47

Reagent Status Normalization and Reblanking Failures 10-47

Correcting Sample Status Errors 10-48

Using Pending Status 10-52

Correcting Communications Status Errors 10-53

Correcting Run-time Errors 10-60

Correcting Error Conditions 10-64

Starting Up After a Power Failure 10-68

Starting Up After a Fatal Disk Error 10-70

Appendixes

A Glossary A-1

B Safety Summary B-1

C Service and Supplies C-1

D Accessories and Options D-1

E Specifications E-1

F LIS Communications F-1

G Relocation Instructions G-1

Index Index-1


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Contents-10

Figures Page

2-1 Express Plus 2-8

2-2 Sample Transport Components 2-10

2-3 Primary Sample Tube Tray and Sample Tray Cover 2-11

2-4 Reagent Tray and Transport 2-11

2-5 Wash and Waste Pumps and In-Line Filter 2-12

2-6 Distilled Water Bottle and Waste Bottle 2-13

2-7 Digital Diluter, Solenoid Valve, and Syringe 2-14

2-8 Probe Assembly 2-16

2-9 Cuvette Handling Components 2-18

2-10 Cuvette Waste Drawer and Biohazard Liner 2-19

2-11 Optical Assemblies 2-21

2-12 Communication Subsystem Components 2-22

2-13 Communication Ports (Right, Side Panel) 2-23

2-14 User Interface Subsystem Components 2-24

2-15 Floppy Disk Drive 2-26

2-16 Express Plus Function Keys and Cursor Keys 2-26

2-17 Express Plus Fixed-Function Keys 2-27

2-18 System Keys, Paper Advance Key, and System Printer 2-28

2-19 Screen Zones 2-34

2-20 Software Map for the Express Plus 2-35

2-21 Probe and Fluid Path 2-37

2-22 Cuvette Path 2-39


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Contents-11

Figures (Continued) Page

3-1 Outlier Rejection 3-12

3-2 Flowchart of Control Rule Evaluations 3-36

3-3 Control 1 Results 3-39

3-4 Control 2 Results 3-39

4-1 Main Menu Screen 4-3

4-2 Main Menu Programs and Functions 4-5

4-3 Worklist Program Map 4-7

4-4 Patient Results Program Map 4-11

4-5 Calibration Data Program Map 4-14

4-6 Q.C. Statistics Program Map 4-22

4-7 Definitions Program Map 4-33

4-8 Definitions/Tests/Parameters Screen (Defined Test) 4-35

4-9 Definitions/Profiles/Selection Screen (Example) 4-36

4-10 Definitions/Control/Limits Screen (Example) 4-37

4-11 Definitions/Calibrator/Concentrations Screen (Example) 4-38

4-12 Definitions/Blanks/Selection Screen (Example) 4-39

4-13 Options Program Map 4-49

4-14 Diagnostics/Maintenance Program Map 4-57

4-15 Precision Check Screen (Example) 4-59

4-16 Diagnostics Maintenance/Lamp Alignment Screen 4-60

4-17 Diagnostics Maintenance/System Version Screen (Example) 4-61

4-18 Diagnostics Maintenance/Probe Tip Calibration Screen 4-62

4-19 Load Alternate Program Map 4-64

4-20 Load Alternate Program Screen 4-64


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Contents-12


5-1 Options/System Options Screen With Default Values 5-5

5-2 Options/Printing Options Screen (Example) 5-7

5-3 Options/Test Order Screen (Example) 5-9

5-4 Definitions/Tests Screen 5-12

5-5 Definitions/Tests/Parameters Screen (Defined Test) 5-14

5-6 Definitions/Tests (Ratio)/Parameters Screen 5-15

5-7 Definitions/Tests (Off-System)/Parameters Screen 5-15

5-8 Definitions/Tests/Reagents Screen (Example) 5-17

5-9 Definitions/Tests/Assay Order Screen (Example) 5-18

5-10 Definitions/Tests/Calibrator Concentrations Screen 5-19

(Example)

5-11 Definitions/Tests/Controls Screen (Example) 5-20

5-12 Definitions/Tests/QCSystems Screen 5-22

5-13 Definitions/Profiles Screen (Example) 5-24

5-14 Definitions/Profiles/Selection Screen (Example) 5-25

5-15 Definitions/Controls Screen (Example) 5-27

5-16 Definitions/Control/Limits Screen (Example) 5-29

5-17 Definitions/Calibrators Screen (Example) 5-30

5-18 Definitions/Calibrator/Concentrations Screen (Example) 5-31

5-19 Definitions/Blanks Screen (Example) 5-33

5-20 Definitions/Blanks/Selection Screen (Example) 5-34

5-21 Options/Disk Options Screen 5-39

6-1 Fixed Function and Cursor Keys 6-8

6-2 System Keys and Paper Advance Key 6-8

6-3 Startup Screen 6-11

6-4 Preparing the System 6-12


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Contents-13


6-5 Worklist/Tests Screen (Example) 6-14

6-6 Sample Loadlist (Example) 6-22

6-7 Loading the Reagent Tray 6-24

6-8 Verifying Conditions and Supplies 6-25

6-9 Reagent Loading Screen (Example) 6-26

6-10 Worklist/Tests Screen (Example) 6-31

6-11 System Status/Pending Status Screen (Example) 6-33

6-12 System Status Screen (Example) 6-37

6-13 System Status/System Details Screen (Example) 6-38

6-14 Run-Time Report for Routine Samples (Example) 6-39

6-15 Patient Results Screen (Example) 6-43

6-16 Collated Patient Report (Example) 6-49

6-17 End-of-Day Cleaning 6-52

7-1 Definitions/Tests/Parameters Screen (Example) 7-8

7-2 Definitions/Tests/Calibrator Concentrations Screen 7-9

(Example)

7-3 Calibration Data Screen (Example) 7-10

7-4 Calibration Data/Parameters Screen (Example) 7-11

7-5 Calibration Data/Data Screen (Example) 7-14

7-6 Reagent Loading Screen (Example) 7-16

7-7 Run-Time Report (Calibrator and Error Log) 7-17

7-8 Definitions/Tests/Controls Screen (Example) 7-22


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Contents-14


7-9 Definitions/Tests/QCSystems Screen 7-24

7-10 Q.C. Statistics/Data Screen (Example) 7-26

7-11 Q.C. Statistics/Levey-Jennings Screen (Example) 7-28

7-12 Q.C. Statistics/Data/Details Screen (Example) 7-30

7-13 Q.C. Statistics/Summary Statistics Screen (Example) 7-33

7-14 Q.C. Statistics/Data Screen with Print Functions (Example) 7-35

7-15 Example of Q.C. Data Report (F2 Test Excluded) 7-37

7-16 Example of a Levey-Jennings Report (F2 Control) 7-38

7-17 Q.C. Statistics/QCSystems Screen (Example) 7-39

7-18 QCSystems Report (Example) 7-40

7-19 Run-Time Report (Control Log and Error Log) (Example) 7-41

8-1 Help Screen for Main Menu/Patient Results 8-4

8-2 Status Program Map 8-5



8-5 System Details Options Map 8-8

8-6 System Status/Reagent Status Screen (Example) 8-11

8-7 Reagent Status Options Map 8-11

8-8 System Status/Sample Status Screen (Example) 8-14

8-9 Sample Status Options Map 8-15


8-11 Pending Status Options Map 8-18

8-12 System Status/Communications Status Screen (Example) 8-20

8-13 Communications Status Options Map 8-21

9-1 Cleaning the Probe Tip 9-8


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Contents-15


9-2 Precision Check Screen (Example) 9-9

9-3 Precision Check Result (Example) 9-11

9-4 Front Panel 9-12

9-5 Fan Filter (Right, Side Cover) 9-14

9-6 Fan Filter (view from system back cover) 9-15

9-7 Pump Cover Location 9-16

9-8 Wash and Waste Pump Tubing 9-17

9-9 Stretching the Pump Tubing 9-18

9-10 Removing the Probe Cover 9-19

9-11 In-Line Filter 9-20

9-12 Removing the Top, Front Cover 9-21

9-13 Digital Diluter Syringe 9-22

9-14 Adjusting the Syringe 9-23

9-15 Installing the Top, Front Cover 9-25

9-16 Installing the Probe Cover 9-25

9-17 Preparing for Lamp Replacement 9-27

9-18 Lamp Assembly 9-28

9-19 Adjusting the Lamp 9-30

9-20 Fuseholder Location 9-31


9-22 Moving the Probe Up 9-33

9-23 Removing the Probe Tip 9-34

9-24 Installing a New Probe Tip 9-35

9-25 Probe Tip Calibration Screen 9-36

9-26 Probe Calibration Constants Report (Example) 9-36


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Contents-16



9-28 Removing the Top, Front Cover 9-38

9-29 Digital Diluter Syringe 9-39

9-30 Adjusting the Syringe 9-40

9-31 Installing the Top, Front Cover 9-41

9-32 Installing the Probe Cover 9-41

9-33 Filling the Water Bath 9-44

9-34 Installing the System Printer Paper 9-45



10-3 Correcting Cuvette Status Errors 10-22

10-4 System Status/Reagent Status Screen (Example) 10-44

10-5 System Status/Sample Status Screen (Example) 10-48


10-7 System Status/Communications Status Screen (Example) 10-53

G-1 Preparing the System for Relocation G-7

G-2 Removing the Bottles and Cuvette Waste Drawer G-7

G-3 Installing Caps in the Water Bath Vent Holes G-8

G-4 Connecting the Cables G-9

G-5 Installing the Reagent Tray G-11

G-6 Installing the Sample Tray G-12

G-7 Replenishing the Supplies G-13


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Contents-17

Tables Page

2-1 Sample and Reagent Transport Subsystem Components 2-9

2-2 Fluid Subsystem Components 2-12

2-3 Cuvette Subsystem Components 2-17

2-4 Photometer Subsystem Components 2-20

2-5 Communications Subsystem Components 2-23

2-6 User Interface Subsystem Components 2-25

2-7 System Key Functions 2-29

2-8 Guidelines for Moving Through the Software 2-32

2-9 Screen Components and Fixed-Function Keys 2-33

2-10 Status Zone Information 2-34

3-1 Summary of Curve Types 3-28

3-2 Error Flags for a Rate and/or Response 3-29

3-3 Error Flags for a Result 3-30

3-4 Automatic Reruns 3-31

3-5 Automatic Dilution and Rerun 3-32

6-1 Fixed-Function and Special Keys 6-7

6-2 System Key Functions 6-9

6-3 Automatic Reruns 6-34

6-4 Automatic Dilution and Rerun 6-35

6-5 Run-Time Report Flags for Routine Samples 6-40

7-1 Corrective Action: Schedule and Run the Calibrators 7-18

7-2 Corrective Action: Determine Cause of Error, Modify

Data, then Rerun Curve 7-19

7-3 Calibration Error Flags and Corrective Actions 7-20

7-4 Run-time Error Flags for Controls 7-42


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Contents-18

Tables (Continued) Page

9-1 Express Plus Preventive Maintenance Schedule 9-4

9-2 Fuse Ratings 9-30

10-1 Status and Error Messages 10-5

10-2 System Details Status Messages 10-14

10-3 System Status Errors 10-19

10-4 Reagent Status Errors and Flags 10-45

10-5 Sample Status Errors and Flags 10-49

10-6 Communications Status Messages and Errors 10-54

10-7 Run-time Report/Error Flags (All Sample Types) 10-60

10-8 Using System Keys to Correct Errors During Operation 10-65

10-9 Correcting General Error Conditions 10-66

C-1 Replacement Parts C-5

C-2 Operator Service Kit Parts C-6

C-3 Ordering Supplies C-7

C-4 Ordering Accessories and Options C-8

F-1 Communication Protocols F-4

F-2 Pin Layout for Enabled Pins F-5

F-3 Software Setup Options F-6

G-1 Fuse Ratings G-5


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Preface-1

Preface

This manual accompanies your Express Plus cinical chemistrysystem and serves two basic functions:

The first function of this manual is to teach new operators theprinciples, correct operation, and preventive maintenance ofthe Express Plus.

The second function of this manual is to provide ongoingsupport for all operators of the Express Plus. For example,this manual provides answers to detailed questions and alsoprovides troubleshooting information.

The first four sections of this mahual provide referenceinformation about the principles, calculations, and programs ofthe Express Plus. Sections 5 through 9 provide step-by-stepinstructions for operating the Express Plus. For complete

information about how to use this manual, refer to Section 1,Using This Manual.

Revision B of theExpress Plus Operators Manual was issuedJanuary 2000.

This manual contains the following sections and appendixes:

Section 1 Using This Manual

Section 2 Understanding the Express Plus

Section 3 Understanding the System Calculations

Section 4 Understanding the Express Plus Programs

Section 5 Setting Up the Express Plus

Section 6 Operating the Express Plus

Section 7 Using the Calibration Data and Q.C. StatisticsPrograms

Section 8 Using the HELP and STATUS Programs

Section 9 Maintaining the Express Plus

Section 10 Troubleshooting the Express Plus

Appendix A Glossary

Appendix B Safety Summary

Appendix C Service and Supplies

Appendix D Accessories and Options

Appendix E Specifications

Appendix F LIS Communications

Appendix G Relocation Instructions


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Preface


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Using This Manual 1-1

1 Using This Manual Page


Who Should Read This Manual 1-3

How to Find the Information 1-4

Conventions Used in This Manual 1-5

Special Terms Used in This Manual 1-6

Labels Used on the System 1-7

Other Express Plus Documents 1-8


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About This SectionThis section explains how to use yourExpress Plus OperatorsManual, which is shipped with your Express Plus and containsreference information about the Express Plus and procedures foroperating, troubleshooting, and maintaining the system.

Who Should Read This Manual

This manual contains information written for clinical laboratoryprofessionals to:

learn about the Express Plus hardware and software

customize system parameters and test parameters

perform daily operating tasks

maintain system files

perform system maintenance and troubleshooting


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1-4 Using This Manual

How to Find the Information

This manual contains 10 major tabbed sections, plus 7appendixes. Use this chart to find the information that you need:

If you want to . . . Refer to section . . .

learn about the Express Plus features 2 Understanding the ExpressPlus

learn about the Express Plus hardware,software, or operating sequence

2 Understanding the ExpressPlus

learn about the Express Plus test andcalibration calculations

3 Understanding the SystemCalculations

learn how the Express Plus performscontrol rule evaluations

3 Understanding the SystemCalculations

learn about the Express Plus programs 4 Understanding the ExpressPlus Programs

customize installation (system) options,printing options, or test definitions foryour laboratory

5 Setting Up the Express Plus

use the Express Plus to perform yourroutine, daily operating tasks

6 Operating the Express Plus

manage your calibration data andquality control (Q.C.) statistics, andprint Q.C. reports

7 Using the Calibration Dataand Q.C. StatisticsPrograms

use the Help program to obtain onlineinstructions for operating the system

8 Using the HELP andSTATUS Programs

use the Status program to troubleshooterrors or obtain status information

8 Using the HELP andSTATUS Programs

perform routine and correctivemaintenance for the Express Plus

9 Maintaining the ExpressPlus

find the meaning and corrective actionsfor a Status error message

10 Troubleshooting theExpress Plus

correct a system error or problem 10 Troubleshooting theExpress Plus

learn the meaning of an unfamiliarword used in this manual

Appendix A Glossary

contact Bayer Diagnostics to ordersupplies or obtain service for yourExpress Plus

Appendix C Service andSupplies

interface your Express Plus to anLaboratory Information System (LIS)

Appendix F LISCommunications

move your Express Plus to a newlocation

Appendix G RelocationInstructions


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Conventions Used in This Manual

This manual uses certain typographical conventions to clarifymeaning in the text. Other conventions, such as symbols, areused to help you identify the kind of information. This chart

explains the conventions used in this manual:

When you see . . . Then . . .

all capital, italic letters in thetext, such asENTER

press the key on the Express Pluskeyboard or the system key on thefront panel of the system that hasthe label you see in the text

bold type in the text:

with a function key designation,such as F1 Worklist

describing a screen field orvalue (Test Nameor Gluc_HK),or an error message (Errordetected Press Status)

press the matching function key onthe system keyboard

this is the name of a field, a fieldvalue, or a message that shows onthe system screen

read the statement next to thesymbol. The statement is alertingyou to an operating hazard that cancause personal injury.

read the statement next to thesymbol. The statement is alertingyou to a potentially biohazardouscondition.

read the statement next to thesymbol. The statement is alertingyou to a possibility of productdamage or loss of data.

read the statement next to thesymbol. The statement is alertingyou to information that requiresyour attention.

WARNING

BIOHAZARD

CAUTION

NOTE


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Special Terms Used in This Manual

In the text of this manual and on the Express Plus screen you willread some special terminology related to your activities at theExpress Plus. This chart explains the meaning of those special

terms:

When you read . . . It means . . .

type to use the system keyboard to enter informationor data on the screen

scan to pass the optional, hand-held bar code wandacross the printed bar codes on the TestScheduler, patient request, or primary sampletube, to enter information requested by thesystem

select to make a choice from the available options bymoving the cursor to the option and pressing theSELECT key

selected the screen field described in the text is a selectedfield. When you move the cursor to a field,which shows on the screen as underlined, thenpressSELECT, the field becomes a selected field.

highlighted

(reverse video)

the screen field described in the text is a selectedfield. When you move the cursor to some fieldsand pressSELECT, the fields become highlighted(dark text on a box of amber background) toshow that you selected the field. This is also

referred to as reverse video.

removed the screen field described in the text is no longera selected field. When you move the cursor to ahighlighted or selected field, then pressSELECT,that field no longer shows on the screen as darktext on an amber background, or as underlined.This indicates that the item is no longer selected.


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Labels Used on the System

The labels attached to some system panels use symbols with thetext to clarify the meaning of the text. This chart explains thesymbols used on the labels:

When you see . . . It means . . .

alternating current (AC)

protective conductor terminal

Warning: risk of electrical shock

Warning: risk of personal injury or equipmentdamage (refer to yourExpress Plus Operators

Manual)

Biohazard Warning: risk of potentiallybiohazardous infection

| ON (Mains supply)

OFF (Mains supply)

Fuse

Keyboard

Bar Code Wand (Hand-held)

Printer

Water

This symbol indicates the system meets theEMC Directive of the European Union.

This symbol indicates the system meets thespecifications of the UnderwritersLaboratories, Inc.

!


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Other Express Plus Documents

TheExpress Plus Operators Manualis part of the Express Plusdocument set that is shipped with your system along with yourother user documents. Use the following chart to find

information that you need from the other Express Plus userdocuments in the set:

* If you need additional information about a Bayer Diagnosticsreagent that you use on the Express Plus, refer to the productinsert that accompanies each reagent kit.

If you need . . . Then refer to . . .

a quick reference procedure for anoperating or maintenance task, ora quick reference for trouble-shooting an error message

Express Plus Quick ReferenceGuide

a reagent application for a routinechemistry for the Express Plus*

Express Plus Applications Guide

a therapeutic drug monitoring(TDM) application or a drug ofabuse in urine (DAU) applicationfor the Express Plus*

Express Plus TDM/DAUApplications Guide(accompanies only the Express PlusDrug Monitoring System)

procedures for installing (orre-installing) the Express Plusprogram software

Express Plus Software InstallationInstructions


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Other Express Plus Documents (Continued)

Additional Express Plus user documents are shipped as part ofoptional hardware accessory kits or software option kits.Appendix D,Accessories and Options, in this manual, provides a

place for you to keep any addenda that you receive as part of ahardware accessory or software option kit.

Use the following chart to find the information you need fromoptional Express Plus user documents:

If you need . . . Then refer to . . .

detailed information for writing aninterface protocol for interfacingthe Express Plus to a peripheraldevice (for programmers)

Express Interface SpecificationsManual

(shipped with theCommunications software option)

detailed procedures for using theCommunications software optionand configuring your Express Plusfor communications

Express Communications ManualandExpress Plus Communications

Enabling Disk Instructions

(shipped with theCommunications software option)

detailed procedures for using thesample tube tray, hand-held barcode wand, and Test Scheduler

Express Plus Positive SampleIdentification (PSID) Addendum

(shipped with the Positive SampleIdentification software option)

detailed procedures for connectingand using the external printer withthe Express Plus

Express Plus External PrinterAddendum

(shipped with the Express PlusExternal Printer hardware option)


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Using This Manual


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Understanding the Express Plus 2-1

2 Understanding the Express Plus Page


Intended Use 2-3

System Features 2-4

Bar Code Features 2-4

Reagent Carryover Reduction Feature 2-5

Dilution and Rerun Features 2-5

Data Management Features 2-6

Express Plus Subsystems: Principles of Operation 2-8

Sample and Reagent Transport Subsystem 2-9

Fluid Subsystem 2-12

Cuvette Subsystem 2-17

Photometer Subsystem 2-20

Communications Subsystem 2-22

User Interface Subsystem 2-24

Hardware Accessories and Software Options 2-30

Moving Through the Software 2-32

Screen Zones 2-34

Express Plus Programs 2-35

Operational Sequence 2-37


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2-2 Understanding the Express Plus

2 Understanding the Express Plus (Continued)

This section of the manual explains the various subsystems andcomponents of the Express Plus, like the hardware and software,and explains how the system uses them to assay samples. Use this

chart to find the information that you need in this section.

If you want to learn . . . Refer to . . .

about the Express Plus capabilites Intended Use

about the Express Plus features System Features

how the Express Plus uses its varioussubsystems and components

Express Plus Subsystems:Principles of Operation

about the sample and reagenttransports and how they handlesamples and reagents loaded on thesystem

Sample and Reagent TransportSubsystem

about the fluid subsystem and how itaspirates and dispenses samples andreagents, as well as moving otherfluids through the system

Fluid Subsystem

about the cuvette subsystem and howit handles the cuvettes

Cuvette Subsystem

about the photometer subsystem andhow it measures reaction mixtures

and calculates results

Photometer Subsystem

about the communications subsystemand how it manages the internalsystem data

Communications Subsystem

about the user interface subsystemand how its components form acommunication link between you andthe Express Plus

User Interface Subsystem

about the hardware accessories andsoftware options that you canpurchase for your Express Plus

Hardware Accessories andSoftware Options

how the Express Plus software works,and how you can move through thesoftware to perform tasks

Moving Through the Software

about the programs and functionsavailable on the Express Plus

Express Plus Programs

how the Express Plus uses itssubsystems and components to assaysamples

Operational Sequence


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About This Section

This section provides background information about how theExpress Plus operates and information to help you understandand use the Express Plus hardware and software.

Intended Use

The Express Plus is a clinical chemistry system that measures andquantitates concentrations of chemistry analytes in serum orurine. The system is intended for use by clinical laboratoryprofessionals.

The Express Plus has the following system capabilities:

assays up to 180 tests per hour for single-reagent applications accepts up to 26 reagents on-board at one time

allows you to load and assay stat patient samples and controls

allows you to enter requests for up to 360 samples and 48 tests

allows random-access and batch testing

automates pipetting and diluting samples and reagents, andwashing probes and tubing

uses a built-in bar code reader to scan reagents loaded on thereagent tray

allows you to enter test requests from the keyboard, by usingan optional, hand-held bar code wand, or by downloading therequests from a Laboratory Information System (LIS)

monitors and reports quality control data and statistics for upto six controls per test

automatically dilutes and reruns samples, when required

provides online assistance through the integrated Helpprogram

provides current information about the operating status of thesystem through the integrated Status program

provides real-time or collated printing of all results obtainedby the system

provides user interface software languages as a user-selectableoption

allows communication from three RS-232 ports


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System Features

The Express Plus uses extensive software functions for systemsetup and verification, automated dilution and rerun of samples,and data management. These major system features contribute to

the efficiency and ease of use of the Express Plus. The followingparagraphs explain these features of your system.

Bar Code Features The Express Plus offers two bar code features. These featuresreduce the sample and reagent identification errors byeliminating or minimizing keyboard entry of information aboutsamples, reagents, and tests.

The bar code features include the reagent bar code scanner andthe optional, hand-held bar code wand and Test Scheduler.

Reagent Bar Code Scanner

The reagent bar code scanner is provided as standard hardwareon the Express Plus. The reagent bar code scanner allows thesystem to verify reagent loading, reagent positions on the reagenttray, and reagent bottle types before the start of each run.

Optional Bar Code Accessories

The optional, hand-held bar code wand and Test Scheduler areprovided as part of the Positive Sample Identification softwareoption. This option allows you to schedule samples and testswith minimal keyboard entry, reducing typing errors and the

possibility of incorrect patient identification.

The bar code wand and Test Scheduler allow:

entry of requests into the worklist without typing at thekeyboard

control of sample placement on the sample tray

aspiration of samples directly from the patients primarysample tubes

association of a unique bar-coded request number with thepatient sample, and association of patient results with thecorresponding bar-coded sample tube


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Reagent CarryoverReduction Feature

The Express Plus can automatically wash probes and tubingbetween the use of reagents that chemically interfere with oneanother. This automated feature reduces the amount of reagent-to-reagent carryover between tests. The system uses reagent orsystem-distilled water to perform the number of wash cycles that

you define to occur between the interfering tests.

The Express Plus can use one or two wash cycles of reagent ordistilled water between tests. If you need to wash with a loadedreagent, the system uses the reagent from the reagent tray tominimize operator intervention during the run. If you need towash with water, the system automatically uses the distilled waterfrom the distilled water bottle to wash between interfering tests.

Dilution and RerunFeatures

The Express Plus offers automatic or manual dilution and rerunfeatures. You maintain control of the automatic operation by

defining a dilution rerun value in the test definition. You canmodify the defined rerun dilution ratio as required. You canalso manually dilute and rerun samples.

Automatic Dilutions and Sample Reruns

The Express Plus automatically dilutes and reruns samplesaccording to parameters that you define for each test. Thesystem automatically reruns any samples with results that areabove the concentration limit, or above or below the absorbancelimits that you define for the test, and automatically corrects theresult for the rerun dilution ratio.

If a sample requires dilution and rerun, the Express Plusperforms an automatic dilution according to the rerun dilutionratio that you define for the test. The rerun dilution ratios youcan use are 1, 2, 5, or 10, depending upon the defined samplevolume for the test.

For example, if you define a rerun dilution of 1:2 for a test thatuses a 30 L sample volume, the system uses 15 L of sample, orhalf the defined sample volume, to rerun the test.

If you have a test that uses a sample volume of 6 L, you cannotuse a rerun dilution ratio of more than 1:2, because the smallestsample volume the digital diluter can use is 3 L. Any other

ratio would require a sample volume smaller than 3 L. In thiscase, you can manually dilute the sample before you load it onthe system, then manually correct the result for the dilution.

To obtain more information about appropriate dilution ratios forthe tests you assay on the Express Plus, contact theBayer Diagnostics Technical Assistance Center.


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Dilution and RerunFeatures(Continued)

Manual Dilutions and Sample Reruns

You can manually dilute samples that the Express Plus cannotdilute automatically due to sample volume restrictions. If youmanually dilute a sample and load it on the sample tray, youmust then multiply the printed result by the appropriate dilutionfactor to obtain the corrected result.

If an error flag prints with an automatic rerun result, you canmanually rerun that sample again. If the sample was diluted forits first rerun, the Express Plus automatically dilutes the samplebefore its manual rerun. You can also manually rerun samplesthat did not have error flags associated with their results.

Data ManagementFeatures

The Express Plus offers a variety of flexible data managementfeatures. Some of the major features that offer flexibility in data

management are: the printed results reports and error flags that print on those

reports

the quality control program, its control rule evaluationmethods, and the associated quality control reports

the ability to back up and restore all data files on the system

Results Reports

The Express Plus offers several options for printing patientresults and other results. Two kinds of result reports are

available: run-time reports or collated patient reports. Refer toSection 5, Setting Up the Express Plus, for more informationabout setting the options for your run-time and collated reports.

A run-time report contains the results for an individual test runfor a sample (for example, a Glucose HK result for samplenumber 20). This report prints on the system printer or optionalexternal printer as the system calculates the result at the time ofthe run. You can set the printing options for the run-timereports and modify the option settings as required. Run-timereports can include any combination of the following data:patient results, calibration and control results, and/or result(error) flags that print with the result and provide added

information about the result.

A collated patient report contains the results for all tests run fora sample. This report can also include demographic informationabout the patient. After the tests are completed for a sample,you can instruct the Express Plus to print the collated report forthat sample. You can set the printing options for the collatedreport to include routine samples and/or Stat samples, to containa customized report heading, and to print on the system printeror optional external printer.


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Data ManagementFeatures(Continued)

Online Quality Control (Q.C.)

The Express Plus maintains an online quality control database ofcumulative data for up to six different controls per test. Thesystem calculates and maintains actual and lifetime summarystatistics for each control and test combination in the database.

The Q.C. Statistics program provides different data formats thatyou can select to view Q.C. data:

the Data screen shows your Q.C. data in a tabular format

the Levey-Jennings screen shows the data on a Levey-Jenningsplot

the Summary Statistics screen shows the expected, actual, andlifetime cumulative statistics for all of the controls defined fora test

The stored data includes control results (data), statistics, andLevey-Jennings plots, each of which are also available as printedreports. The Q.C. Statistics program uses control rule analysis tointerpret and evaluate the Q.C. data at the time of the run. If acontrol result violates a control rule that you define for the testand control, the system flags the result on the run-time report.

An additional feature of this program is the Automatic TestShutdown option. When you enable this option, the system canautomatically stop assaying a test if the defined control rules areviolated.

Refer to Section 7 subtab,Defining Control Values/Managing

Q.C. Data, for more information about the Q.C. Statisticsprogram features.


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Sample and ReagentTransport Subsystem

The sample and reagent transport subsystem identifies andpositions samples and reagents for testing. Table 2-1 explainsthe sample and reagent transport subsystem components:

Table 2-1. Sample and Reagent Transport Subsystem Components

(Continued on the next page)

Component Description and Function

Primary Sample TubeTray

the 20-position, optional sample tray, shownin Figure 2-3, that holds and positionscentrifuged patient samples in their primarysample tubes. The primary sample tubetray can hold the following tube sizes:13x75, 13x100, 16x75, or 16x100mm.

Sample Integrity Tray the 40-position circular tray, shown inFigure 2-2, that holds samples in plastic,disposable sample cups and rotates each

sample to the sample aspiration positionduring testing.

Sample Transport an electromechanical device, shown inFigure 2-2, that rotates the sample tray.The sample transport has a molded basethat houses a motor assembly, a drive hub,and a printed circuit board. The printedcircuit board has three optical detectors forsensing the position of the sample transport.

Sample Integrity TrayCover

an amber, plastic cover that fits over thesample tray, as shown in Figure 2-2. Thistray cover contains a felt material that,when moistened, helps maintain theintegrity of the samples by reducing sampleevaporation.

NOTE

If you want to use standard sample cups forcontrols and calibrators on the primary sampletube tray, order primary sample tube inserts (partnumber 1453x215 by calling Bayer Diagnostics at1-800-255-3232.


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Fluid Subsystem(Continued)


Probe the assembly, shown in Figure 2-8, that aspirates,

dilutes, and dispenses samples and reagents. The probecomprises the following assemblies:

an aspiration tip consisting of a stainless steel tubethat holds the fluid, and a copper sleeve thatsurrounds the stainless steel tube and preheats thefluid. A fluid-level detector lead is also attached tothe copper sleeve.

a fluid-level detector wire senses the resistancebetween the fluid level and the aspiration tip whenthe aspiration tip and fluid-level detector wire areimmersed in fluid.

a fluid-level detector lead provides the electricalconnection between the fluid-level detector wire andthe probe body.

the probe body contains a coiled tube about 890mm(35 inches) long, surrounded by a temperature-controlled water chamber. A molded housingencloses and insulates the water chamber.

an inlet port and an inlet/outlet port on the moldedhousing at the top of the probe body. The inlet portis used for the aspiration tubing and the coaxialinlet/outlet port is used for the water bath.

a probe safety guard, which is a molded plastic coverattached to the probe body. The safety guardextends over the aspiration tip and fluid-level

detector wire to help protect you from puncturewounds in a potentially biohazardous area.

a probe thermistor in the probe body senses thetemperature of the fluid in the probe waterchamber.

Table 2-2. Fluid Subsystem Components (Continued)

WARNING

The probe tip and fluid-level detector wire aresharp and can cause puncture wounds. Toprevent injury to your hands or arms, exercisecaution when working around the probe withoutthe probe cover or probe safety guard installed.

To prevent biohazard contamination, alwayswear gloves, goggles, and appropriate protectiveclothing when you work around or in the areaof the probe.

BIOHAZARD


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Cuvette Subsystem The cuvette subsystem positions and preheats the cuvettes in thesystem, then uses the preheated cuvettes to hold the reactionmixtures in the light path for measurement. Table 2-3 describesthe cuvette subsystem components:

Table 2-3. Cuvette Subsystem Components



Cuvette Strips the strips of disposable, molded acrylic, eachconsisting of five connected cuvettes, shownin Figure 2-9, that hold the reaction mixturein the light path for measurement.

Cuvette Magazine a disposable cartridge, shown in Figure 2-9,that inserts 13 cuvette strips into the cuvettefeeder.

Cuvette Feeder the device, shown in Figure 2-9, that movesthe cuvette strips into the cuvette track.The cuvette feeder holds up to 39 cuvettestrips (3 rows of 13 strips, or 195 cuvettes).

Cuvette Preheater an insulated, aluminum chamber, shown inFigure 2-9, that heats or cools five cuvettestrips before they enter the cuvette track.The cuvette preheater maintains thetemperature of the cuvettes at 30 or 37 C.

Cuvette Track an insulated, aluminum chamber, shown inFigure 2-9, that incubates the reactionmixtures in the cuvettes at 30 or 37 C.The cuvette strips move in the track from

the preheater to the read station, then to thedispense station where the probe dispensesthe preheated reaction mixtures into thecuvettes. The cuvettes continue to moveback and forth in the track until thepolychromator measures all of the reactionmixtures in the cuvette strip.

Cuvette Edge Detector an electronic device that senses the edge ofeach cuvette well in a cuvette strip at theread station, and triggers the polychromatorto begin measuring the reaction mixturescontained in the cuvettes.


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Photometer Subsystem The Express Plus photometer subsystem obtains photometricdata and determines the absorbance of the reaction mixtures.Table2-4 explains the photometer subsystem components:

Table 2-4. Photometer Subsystem Components


Photometer Board a printed circuit board that uses the followingassemblies to measure, at two wavelengths, theamount of light that a sample transmits:

a photodiode array produces a currentproportional to the amount of light that fallsonto the array from a reaction mixture(incident light). The diode array producescurrent at the following wavelengths: 340, 380,405, 510, 540, 570, and 600 nm. A mask andfilters cover the diode array elements and

reduce stray light so that only a specificwavelength of light strikes each element.

seven photometer channels and an outputbuffer on the photometer board amplify andconvert the signal from the photodiode arrayinto a frequency that the software uses tocalculate absorbance data. The output of eachphotometer channel is a frequency related tothe diode array current. The output buffertransmits all of the output signals from thephotometer channels and makes these signalsavailable to the controller.

Optics the optical assemblies, shown in Figure 2-11,provide, disperse, and focus the radiant energyrequired to measure samples. The opticalassemblies are:

a quartz halogen lamp that provides radiantenergy to travel through the light path.

a polychromator that comprises the imagingoptics and holographic grating, and dispersesthe radiation to produce polychromatic light.

imaging optics that focus the light. A planoconvex lens focuses the light from the quartzhalogen lamp into the center of a cuvette

containing a reaction mixture. A biconvex lensthen focuses the light that exits from thecuvette into the entrance slit of thepolychromator. The light strikes a concave,holographic grating, which focuses anddisperses the spectrum of light across thephotodiode array on the photometer board.


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CommunicationsSubsystem

The Express Plus communications subsystem components, shownin Figure 2-12, form a communication link among the variousparts of the Express Plus. Figure 2-12 shows the componentinteractions within the communications subsystem and withother subsystem components (the solid lines in Figure 2-12

indicate the communications subsystem components; the dottedlines indicate components of other subsystems). Thesecommunication subsystem components collect, verify, process,and manage system data. Table 2-5 explains thecommunications subsystem components.

Refer also to the next section, User Interface Subsystem, forinformation about the optional bar code wand, Test Scheduler,and external printer.

Figure 2-12. Communication Subsystem Components

CentralProcessing

Unit(CPU)

Screen

Floppy Disk Drive

Keyboard

Bar Code Wand

Reagent Bar CodeScanner

System Keys

RS-232 Ports

Parallel Port

External Printer

Probe Board

Track Board

Transport Boards

Photometer Board

Hard Disk Drive


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Rev. B 1/20


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User InterfaceSubsystem(Continued)

Table 2-6 describes the components of the the user interfacesubsystem:

Table 2-6. User Interface Subsystem Components


Screen a cathode ray tube (CRT), shown in Figure 2-14,that shows the program information in text orgraphic formats and prompts you to takeoperational actions. The screen is a nine-inch,diagonal CRT with text in amber on a darkbackground.

Floppy Disk Drive a drive, shown in Figures 2-14 and 2-15, that uses3 -inch floppy disks to store and retrievecalculations, parameters, calibrations, and results.The CPU transfers data from the floppy disk toRandom Access Memory (RAM). When data iscollected and calculated, you can move the data toa floppy disk for storage. The floppy disk drivehas an eject pushbutton that opens the drive fordisk removal and a drive indicator that illuminateswhen the disk drive accesses the floppy disk toread or write information on that disk.

Keyboard an alphanumeric keyboard, shown in Figures 2-14,2-16, and 2-17, used to select programs andcommands, and enter data into the system. Thesystem uses the following keys on the keyboard:

function keys (F1through F8), shown anddescribed in Figure2-16, are used to select

software options that show on the screen. Thefunctions associated with the function keys varywith each screen.

four cursor keys, shown in Figure 2-16, areused to move the cursor on the screen fromone screen field to another.

fixed-function keys, shown and described inFigure 2-17, are dedicated keys used to performspecific system functions.

System Keys the keys located on the front panel of the systemthat you use to start, stop, or pause operations.System keys are shown in Figure 2-18 and

described in Table 2-7.

Paper AdvanceKey

the key shown in Figure 2-18 that moves theprinter paper through the system printer.

System Printer a 40- or 80-column thermal printer, shown inFigure 2-18, that prints parameters, tests, data,and reports.

NOTE

For more information about using the systemkeys and the paper advance key, refer toSection6, Operating the Express Plus.


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User InterfaceSubsystem(Continued)

start the testing sequence from the beginning, orresume testing that you previously stopped or paused.When you pressSTART, the Express Plus:

primes the lines if you filled the distilled waterbottle

verifies the system operating temperatures

goes to the Warming Up or Running state

identifies the reagents on the reagent tray

waits for you to verify reagent loadinginformation, then starts the tests in the worklist

interrupt operations at the next available stoppingpoint. When you pressPAUSE, the Express Plus:

stops dispensing new tests after completing the testin progress, dispenses the reagents for multi-reagent tests, then stops all dispensing operations

continues measuring reaction mixtures that containsamples

waits for you to press START to resume assayingtests at the point of interruption

stop the testing sequence. When you pressSTOP, the

Express Plus: stops dispensing the samples and reagents

stops measuring the reaction mixtures that aredispensed into cuvettes

erases any test results that are not completed

stops system operations

waits for you to restart the tests in the worklist

To . ..Press . . .

stop

strt

puse

Table 2-7. System Key Functions


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Hardware Accessoriesand Software Options

The following hardware accessories and software options areavailable for the Express Plus:

External Printer

The Express Plus external printer is an optional hardwareaccessory. The external printer is a stand-alone, dot-matrixprinter. For specific setup and operating details, refer to theoperating manual for your external printer.

The external printer is used to print worklists, run-time reports,patient reports, quality control reports, and test results on acollated patient report. The external printer connects to theparallel printer port at the right side of the system. The printerconfiguration is set by Bayer Diagnostics Field ServiceEngineers at the time of installation.

For more information, refer to theExpress Plus External PrinterAddendum, shipped with your external printer.

Positive Sample Identification Software Option

The Positive Sample Identification (PSID) Option is required forusing the bar code wand, primary sample tube tray, and TestScheduler for positive sample identification. These componentsallow you to scan a bar code label on a primary sample tube andenter the patient request into the worklist without using thekeyboard. The system associates the results for a sample with thebar code label on the primary sample tube. You can also scanthe test requests from bar codes printed on the Test Scheduler.

The optional bar code wand, shown in Figure 2-14, and the TestScheduler can:

scan and schedule bar-coded patient samples

scan and schedule bar-coded tests, profiles, calibrators,controls, and blanks defined for the Express Plus, which allowsfor faster, more efficient worklist scheduling

enter data and select options without using the keyboard,which helps eliminate typing errors

For more information, refer to theExpress Plus Positive SampleIdentification (PSID) Addendum, shipped with the softwareoption kit.


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Hardware Accessories

and Software Options(Continued)

Communications Software Option

This software option is required for communicating between ahost Express Plus and any of the following peripheral devices:

a remote Express Plus

a Bayer Diagnostics 664, Fast4System

an external computer, such as a Laboratory InformationSystem (LIS)

For information about cabling, configuring the ports, enabling thesoftware option, and programming for communications, refer tothe following documents that are shipped with thecommunications software option:

Express Plus Communications Enabling Disk Instructions

Express Communications Manual

Express Interface Specifications Manual

To order accessories or software options, call Bayer Diagnostics.Refer to Appendix C, Service and Supplies, forBayer Diagnostics addresses and telephone numbers forplacing your orders.


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Moving Through the Software

The Express Plus uses extensive software functions to collect dataand communicate with you. The software is designed so that youcan easily access information and perform required tasks. The

Express Plus software uses the following software components:

programs

A program is a top-level software component that presents youwith a list of related functions called a menu. The ExpressPlus software has eight programs in its Main Menu.

menus

A menu is a list of options available within a program. Youselect the option you need from a menu on the screen.Making a selection from a menu can cause a new menu or afunction screen to show on the screen.

screens

A screen is a page of information that shows on the systemscreen. This information can be data to review, information toenter, or tasks to perform. Screen zones are components usedat each screen. Refer to Screen Zonesfor more information.

fields

A field is an area on a screen where you can enter data ormake a selection for the associated option.

prompts

A prompt is an instruction that shows on the screen andexplains what to do to perform an action or to show anotherscreen.

To move through the software, follow the general guidelinesexplained in Table 2-8. You will also use the screen componentsand keys described in Table 2-9 to move through the software.

Table 2-8. Guidelines for Moving Through the Software

If . . . Then . . .

a menu shows on

the screen

press the function key that corresponds to the

option you need

a screen showswithout a blinkingcursor

press a function key to select the correspondingoption

a screen shows witha blinking cursor

use the cursor keys to move the cursor to therequired field, then type an entry or pressSELECTto place or remove the highlighting(reverse video) or underlining from a screen fieldor option


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Moving Through the Software (Continued)

You can use the screen components and fixed-function keysdescribed in Table2-9 to move around the screens and movethrough the Express Plus software. Refer to Figure 2-17 for the

locations of the fixed-function keys on the Express Pluskeyboard.

Table 2-9. Screen Components and Fixed-Function Keys

Component or Key Description and Function

Reverse Video a text attribute that shows dark text on a field ofamber background to enclose a field that youselected, such as a calibrator concentration

Cursor a blinking horizontal bar that shows your positionon a screen

Cursor Keys the four arrow keys that you use to move thecursor in the required direction on a screen (left,right, up, or down) to access screen fields oroptions

SELECT the toggle key that either places or removes thereverse video or underlining from a screen fieldor option

TAB the key that moves the cursor from one screenfield to the next, going across the screen from leftto right

ENTER the key that accepts the entries or selections thatyou make at a screen

EXIT the key that moves the software to another screenand causes any entries or modifications to store insystem memory

CANCEL the key that allows you to stop a function thatyou selected to use, and returns any field entriesto the values that were shown before you beganthe function

MAIN MENU the key that moves you to the Main Menu screenfrom anywhere in the software


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Screen Zones The operating information that shows on each screen is groupedinto five categories. Each category always shows in the samescreen position or zone as shown in Figure 2-19. Table 2-10explains the information that shows in the Status zone.

Figure 2-19. Screen Zones

STATUS ZONEshows the systems operating status, date, time,and the number of used cuvettes. Refer toTable2-10 for more information.

PLACEKEEPING ZONEshows where you have moved in the software, fromthe Main Menu selection to where you are now.

Definitions

Tests

Parameters

F1 F2Reagents F3 Assay F4 Calib F5 Controls F6 QCSystem F7 F8Order Concs.

Review data, then

modify if

required.

Press to

store definition

or review anothertest.

Test Name: Glucose Test: Gluc_HKTest Bar Code:015

Test Type: Endpoint Curve Type: Blanked LinearUnits: mg/dL No. of Decimal Places: 0

Primary Wavelength:340 nm Secondary Wavelength:380 nmRead Time/Interval: 20 Sample Blank? NoFactor:

Calibration Interval: 72 HoursNormalization/Reblanking Interval: 8 HoursNo. of Calibrators: 3 No. of Replicates: 2

Low Blank A Limit: -0.100 High Blank A Limit: 0.250Low A Limit: 0.000 High A Limit:2.000Low Normal:65 High Normal: 110Linearity Limit:750 Curve S.D. Limit: 8.0000

PROMPT ZONEshows the prompts and messages that explain whatyou should do or what the system requires.

PROGRAM ZONE

shows the information or program that you canselect from the current screen.

FUNCTION KEY ZONEshows the functions or actions that are available atthe current screen. Key labels F1 through F8 varyas the screens change.

31-MAR-1992 Status: Cuvettes Used: 120 Error detected15:11 Warming Up Maximum: 195 Press Status

Table 2-10. Status Zone Information

This shows . . . And it means . . .

31-MAR-1992

15:11

this is the current date and time

Status: the current operating status of the Express Plus:

Warming Upmeans the system is warming up;wait until the status is Ready

Ready means the system is ready to operate

Running means the system is assaying tests

Reading means the system has stoppeddispensing and is measuring the cuvettes

Standby means either the voltages to the lampare reduced and the water bath is in a standby

state, or the track is in the home position Diagnostics means you are currently in the

Diagnostics/Maintenance program

Cuvettes Used: XXX

Maximum: 195the number of used cuvettes and the maximumnumber of cuvettes that the waste drawer holds

Error detected

Press Statusthe system encountered an error; go to theSystem Status screen for details about the error


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Express Plus Programs The Main Menu contains eight programs (F1through F8). Eachprogram has various functions and/or actions that you can select.Figure 2-20 is a map of the Express Plus programs.

Figure 2-20. Software Map for the Express Plus


Main Menu

F1

F2

Patient Results

F3

Calibration Data

F4

Q.C. Statistics

Worklist

Worklist/Tests:(Patient) Screen

F1

Next Request

F2

Previous Request

F3

Find Request

F4

Insert Request

F5

Erase Request

F6

Load Sample

F7

Results

F8

Demographics

Patient ResultsScreen

F1

Next Request

F2

F3

Find Request

F4

Edit Request

F7

Worklist

F8

More

F1

Recalculate

F2

Rerun

F3

Accept

F6

Erase

F8

Data

Calibration Data/

ParametersScreen

Calibration DataScreen

Q.C. StatisticsScreen

F1

Data

F2

Levey-Jennings

F3

Summary Stats

F8

QCSystem

Previous Request

Calibration Data/Data Screen

F8

Parameters

F4

Edit


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Express Plus Programs(Continued)

Figure 2-20. Software Map for the Express Plus(Continued)

Main Menu

(Continued)

F5

F7

Diagnostics/Maintenance

F8

Load AlternateProgram

Definitions

F1

Test

F2

Profile

F3

Control

F4

Calibrator

F5

Blank

Load AlternateProgram Screen

F1

Boot Floppy

F8

More

DefinitionsMenu

F1

System Options

F2

F3

Test Order

F4

Communications

F5

Disk Options

F6

Reset System

Printing Options

Options

Options Menu

F6

Diagnostics/MaintenanceMenu Screen

F1

F2

Manual Operations

F3

Lamp Alignment

F4

System Version

F5

Probe Tip Calibration

Precision Check

The Express Plus also uses an online Help program that providesinstructions and explanations about screens, screen fields,function keys, fixed-function keys (such as STATUS or PRINT),and system keys (such as STARTor PAUSE).

There is also a Status program, which provides onlineinformation about the operating status of the system, reagents,samples, and worklist. The Status program is very useful introubleshooting and correcting system status errors.

For more information about the Express Plus software, refer toSection 4, Understanding the Express Plus Programs, and toSection 8, Using theHELP andSTATUS Programs.


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Operational Sequence (Continued)

4. The waste pump moves the waste water from the wash stationto the waste bottle.

5. The probe moves to the aspiration position and the reagenttray rotates the required reagent bottle into the aspirationposition.

6. As the aspiration tip and fluid-level detector wire move intothe reagent bottle, the electrical resistance between themchanges. The fluid-level detector wire senses the change inresistance and determines the fluid level, then stops thedownward travel of the probe.

7. The digital diluter controls the volume of reagent that theprobe aspirates from the reagent bottle.

8. The wash pump again moves wash water from the distilledwater bottle through the in-line filter and the solenoid valve,which then directs the flow of wash water to the wash stationto wash the outer surfaces of the aspiration tip and fluid-leveldetector wire. The waste pump then moves the waste waterfrom the wash station to the waste bottle.

9. The probe moves to the sample aspiration position as thesample transport rotates the correct sample cup to the sampleaspiration position.

10. The fluid-level detector wire senses the change in resistanceand determines the fluid level in the sample cup, then stopsthe downward travel of the probe.

11. The digital diluter controls the volume of sample that theprobe aspirates from the cup.

12. Water from the temperature-controlled water bath movesfrom the water bath into the water chamber in the probebody to keep the probe at a constant temperature of 30 or37 C. A thermistor in the probe body senses thetemperature of the water in the water chamber.

13. The copper sleeve that surrounds the stainless steel aspirationtip preheats the reaction mixture, which is now held in thetip, to the temperature of the water in the water chamber.


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Operational Sequence (Continued)

18. After the defined lag time for the dispensed test elapses, thecuvette containing the reaction mixture moves along the trackfor measurement:

a. As the cuvette moves, the system focuses the light fromthe quartz-halogen lamp through the plano convex lensand into the center of the cuvette.

b. The biconvex lens focuses the light that exits from thecuvette into the entrance slit of the polychromator.

c. The concave, holographic grating in the polychromatorfocuses and disperses the spectrum of light across thephotodiode array on the Photometer Board.

d. The mask and glass filters that cover the photodiodearray elements reduce the stray light and cause only aspecific wavelength of light to strike each element.

e. The photodiode array produces a current proportional tothe amount of light that falls on the array from thereaction mixture (incident light), and measures (at thetwo defined wavelengths) the amount of light that thereaction mixture transmits.

f. Each of the seven photometer channels transmit afrequency that is related to the diode array current. Thephotometer channels and output buffer on thePhotometer Board convert the current to an amplifiedvoltage, which is then converted to a frequency that the

digital counters on the Cuvette Track Controller Boardmeasure.

g. The output buffer transmits all of the output signals fromthe photometer channels to the Cuvette Track ControllerBoard.

19. The central processing unit (CPU) uses the programmed testparameters and the data transmitted from the Cuvette TrackController Board to calculate the test result for each reactionmixture.

20. After the Express Plus measures all the reaction mixtures in acuvette strip, the track ejects the cuvette strip into the cuvettewaste drawer.

21. The Express Plus transmits the results to the system printer.The printer generates the run-time report if you selected touse that printing option.


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Understanding the System Calculations 3-1

3 Understanding the System Calculations Page


Calculating Absorbance 3-6

Blanks and Zero Calibrators 3-8

Polychromatics 3-8

Monochromatics 3-9

Common Bichromatics 3-9

Sample Blanking 3-9

Monochromatic Absorbance Check 3-10

Data Selection 3-11

Substrate Depletion 3-11

Outlier Rejection 3-11

Calculating Response Values 3-13

Kinetic Test Type 3-13

Endpoint Test Type 3-15

Two-Point Test Type 3-15

Calibration Methods 3-17

Linear Curve Types 3-17

Blanked Linear Curve Type 3-20

Limited Linear Curve Type 3-21

Enzyme Linear Curve Type 3-21


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3-2 Understanding the System Calculations

3 Understanding the System Calculations (Continued) Page

Calibration Methods (Continued)

Nonlinear Curve Types 3-22

1-Logit4 Curve Type 3-24

2-Logit5 Curve Type 3-24

3-Exponential5 Curve Type 3-25

4-Polynomial5 Curve Type 3-25

Two-Point Normalization 3-26

Qualitative Curve Type 3-27

Summary of Curve Types 3-28

Summary of Error Flags and Calibration Failures 3-29

Calibration Failures 3-30

Normalization or Reblanking Failures 3-30

Summary of Automatic Reruns 3-31

Summary of Control Rules 3-33

How the Express Plus Uses Control Rules 3-33

1-2s Rule 3-34

1-3s Rule 3-34

2-2s Rule 3-34

4-1s Rule 3-34

10x Rule 3-35

Using a Combination of Control Rules 3-35

Sample Interpretation 3-37

Special Considerations for Q.C. Statistics 3-40


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3 Understanding the System Calculations (Continued)

This section of the manual explains the various systemcalculations and internal processes used by the Express Pluswhen calculating results, calibration curves, and evaluating

control rules. Use this chart to find the information that youneed in this section.



how the Express Plus calculatessample absorbances

Calculating Absorbance

how the Express Plus uses blanks andzero calibrators

Blanks and Zero Calibrators

how the Express Plus usespolychromatics to correct absorbancereadings

Polychromatics

how the Express Plus usesmonochromatic absorbance readingsto calculate results

Monochromatics

how the Express Plus usesmonochromatic absorbance readingsto calculate results

Common Bichromatics

how the Express Plus corrects forsample blanking

Sample Blanking

how the Express Plus performs amonochromatic absorbance check toverify that readings fall within thelinearity of the system internalabsorbance limits

Monochromatic AbsorbanceCheck

how the Express Plus uses thevarious data selection algorithms toselect subset cuvette readings andcalculate results

Data SelectionSubstrate DepletionOutlier Rejection

how the Express Plus calculates theresponse values (delta absorbance)for each test type

Calculating Response Values

about the various calibrationmethods, including normalizationand reblanking, available on theExpress Plus

Calibration Methods

about the various error flags andcalibration failures that the ExpressPlus uses while calculating results orcalibrating a test

Summary of Error Flags andCalibration Failures


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3 Understanding the System Calculations (Continued)


how the Express Plus determines if asample will be rerun or diluted and

rerun

Summary of Automatic Reruns

how the Express Plus uses thecontrol rules that you defined foreach test and control to judgewhether the control results representthe expected or previously observedperformance

How the Express Plus UsesControl Rules

how the Express Plus uses acombination of control rules definedfor the same test and control

Using a Combination ofControl Rules

how the Express Plus applies controlrules in a typical test (example) Sample Interpretation

some special considerations toremember when using the ExpressPlus Q.C. Statistics program

Special Considerations forQ.C. Statistics


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About This Section

This section contains information about the calculations andinternal processes performed by the Express Plus:

absorbance

blanks and zero calibrators

polychromatics

monochromatic absorbance check

data selection

response values

calibration methods

summary of curve types

summary of error flags and calibration failures

summary of automatic reruns

control rules and how they are used


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Calculating Absorbance

Absorbance readings are taken on samples every ten seconds asthe samples move in front of the photometer. As light passesthrough the cuvette and sample onto the photodiode, the

photometer circuit generates a current for each wavelength. Thiscurrent is inversely proportional to the amount of light absorbedat each wavelength and is called the sample current.

The sample current readings are taken until the read intervalentered at the Read Time/Intervalfield on the Definitions/Tests/Parameters screen, elapses. The readings are then calculated intoa result.

Zero currents are the readings taken when there is nothingblocking the light source and the photodiode. The zero currentis a reading taken on air. This reading represents zeroabsorbance.

After each retrace of the cuvette track, a new zero current foreach wavelength is taken at least once every twenty seconds. Ifzero currents cannot be taken, the last set of zero currents areused.

Absorbance is calculated as:

Abs(x) = 2-Log (%T)

where:

Abs (x) = the absorbance at a specific wavelength (x) (this is not a bichromatically-corrected absorbance)

Log = the common logarithm function (base 10)

%T = the percent transmittance at wavelength (x)

Since 2 is the Log (100), the equation becomes:

Abs(x) = Log (100)-Log (%T)

%T100

Abs(x)=-Log


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Calculating Absorbance (Continued)

In the ideal case, %T is calculated as:

Sample Current 100

Zero Current

%T=

where:

Sample Current = The electrical output generated by thephotometer when reading the sample atwavelength (x)

Zero Current = the electrical output generated by thephotometer at wavelength (x) when thephotometer is fully exposed to the lightsource. This current represents 100%T (0%)absorbance.

Since the ideal case is not usually observed, the equation for %Trequires another term. When the shutter is closed and no lightenters the photometer, there is still a current generated by thecircuit. This current is called the dark current.

During each retrace of the cuvette track, the system takes severaldark current readings at each wavelength, then averages thereadings for each wavelength. The system then subtracts theaverage from the sample current and zero current for eachwavelength before it calculates %T as:

Sample Current

-Dark Current 100Zero Current-Dark Current

%T=

where:

Dark Current = the current reading generated by thephotometer at wavelength (x) when no lightis entering the photometer


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Calculating Absorbance (Continued)

The final equation for absorbance is:

NOTE

Ln (log base e) is used because the co-processor

does not support log base 10 functions.

Absorbance (x)=

-Ln

Sample Current (x) -Average Dark Current (x)

Zero Current (x) -Average Dark Current (x)

-Ln (10)

where:

-Ln = the negative of the natural logarithm function(log base e)

Average Dark = average of the dark current readings at

Current (x) wavelength (x) produced by the photometercircuit (occurs when no light hits thephotodiode because the shutter is closed)

Blanks and Zero Calibrators

The Express Plus treats blanks and zero calibrators the sameduring calibrations, but you cannot schedule blanks and zerocalibrators to calibrate the same test. But, if a test uses blanks inits calibration, you can use zero calibrators instead of blanks.

Regardless of the test type or curve type, the system checks thelow blank absorbance and high blank absorbance of every blankand zero calibrator replicate. These blank absorbance checksobtain the average of the absorbances at the primary wavelengthand check the absorbance against the low blank absorbance andhigh blank absorbance limits for the test. If the low blankabsorbance and/or high blank absorbance checks fail, a failedcalibration occurs unless you obtain a valid rerun of the failedblank or zero calibrator.

PolychromaticsThe system takes absorbance readings every ten seconds at eachwavelength defined at the Primary Wavelengthand SecondaryWavelengthfields on the Definitions/Tests/Parameters screen fora test. If one or two wavelengths are defined and the SampleBlank?field is set to Yes, the system adjusts the absorbancereadings to yield a single corrected absorbance reading for everyten seconds in the read interval. The system uses these correctedabsorbance readings for data selection and the remainder of theresult calculations.


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Monochromatics If a primary wavelength is defined at the Primary Wavelengthfield on the Definitions/Tests/Parameters screen for a test, andthe Secondary Wavelengthfield is defined as None, allabsorbance readings used to calculate a result aremonochromatic. The system uses the raw absorbance readings

and does not adjust them unless the Sample Blank?field is set toYes.

Common Bichromatics If a secondary wavelength is selected at the SecondaryWavelengthfield on the Definitions/Tests/Parameters screen for atest, the system subtracts the absorbance at the secondarywavelength from the absorbance at the primary wavelength togive a bichromatic absorbance reading. This is done for all pairsof primary and secondary absorbance readings in the readinterval.

For endpoint test types, bichromatics corrects for wavelength-independent absorbance differences from cuvette to cuvette. Forkinetic test types, absorbance differences between cuvettes affectresults only through the rejection of data for substrate depletionor absorbance flagging. Bichromatics also corrects forinterferences from substances that have the same absorbances orrates of change at the primary and secondary wavelengths.

Sample Blanking Sample blanking is applied after absorbance readings arecalculated for bichromatics. The system uses sample blanking

for multiple-reagent tests only when you select Yesat the SampleBlank?field on the Definitions/Tests/Parameters screen for a test.The system takes two absorbance readings just before the lastreagent addition. The system then multiplies the average of thetwo corrected absorbances by the value in the cuvette (at thetime of the blank reading) and divides that value by the fullreaction volume.

This sample blank offset calculation gives the sample blankcorrection. The sample blank correction is then subtracted fromall the absorbances taken in the read time/interval defined at theDefinition