Roche MODULAR ANALYTICS Core User manual

MODULAR ANALYTICS EVO

SWA

Operator’s Manual

Software Version 08-07

MODULAR ANALYTICS EVO SWA

Roche Diagnostics

2 Operator’s Manual · Version 4.1

Document information

Revision history

Edition notice MODULAR ANALYTICS EVO SWA

This manual is for users of the MODULAR ANALYTICS EVO SWA.

Every effort has been made to ensure that all the information contained in this

manual is correct at the time of printing. However, Roche Diagnostics GmbH

reserves the right to make any changes necessary without notice as part of ongoing

product development.

Any customer modification to the instrument will render the warranty or service

agreement null and void.

Software updates are done by Roche Service representatives.

Intended use The MODULAR ANALYTICS EVO SWA is a fully automated system for

immunological and photometric analysis. It is important that the operator read this

manual thoroughly before using the system.

Copyright

©

Manual version Software version Revision date Changes

1.0 07-01 30.05.2002

1.1 07-01 30.09.2002 Data alarms

2.0 07-04 05.05.2004 Structural and content

revision

3.0 08-01 01.03.2006 Supplementation of new

software features

3.1 08-02 10.03.2008 Supplementation of

corrections

4.0 08-07 09.2013 Supplementation of

corrections

4.1 08-07 09.2014 Maintenance E module

Clean

ProCell M/CleanCell M

aspiration tube filters

deleted.

Caution message to

Replacing ProCell M and

CleanCell M procedure

added.

Roche Diagnostics

Operator’s Manual · Version 4.1 3

MODULAR ANALYTICS EVO SWA

Trademarks The following trademarks are acknowledged:

MODULAR, COBAS, COBAS C, COBAS INTEGRA, ELECSYS and LIFE NEEDS

ANSWERS trademarks of Roche.

All other trademarks are the property of their respective owners.

Instrument approvals MODULAR ANALYTICS EVO SWA meets the protection requirements laid down

in IVD Directive 98/79/EC.

The Operator’s manual meets the European Standard EN 591.

Compliance is demonstrated by the following marks:

Contact addresses

For European Union/EFTA:

For outside European

Union/EFTA:

Complies with the IVD directive 98/79/EC.

CUS

®

Issued by Underwriters Laboratories, Inc. (UL) for Canada

and the US.

Hitachi High-Technologies Corporation

24-14. Nishi-shimbashi. 1-chome. Minato-ku

Tokyo. 105-8717 JAPAN

Roche Diagnostics GmbH

Sandhofer Strasse 116

D-68305 Mannheim, Germany

Manufactured for: Roche Diagnostics GmbH

Sandhofer Strasse 116

D-68305 Mannheim, Germany

MODULAR ANALYTICS EVO SWA

Roche Diagnostics

4 Operator’s Manual · Version 4.1

Roche Diagnostics

Operator’s Manual · Version 4.1 5

MODULAR ANALYTICS EVO SWA

Table of contents

Document information 2

Contact addresses 3

Table of contents 5

Preface 7

How to use this manual 7

Where to find information 8

Online Help System 8

Customer information 9

Symbols and abbreviations 10

System description Part A

1 Safety information

Safety classifications A–5

Safety precautions A–6

Safety summary A–9

Safety labels of the system A–20

Disposal of the instrument A–42

2 Overview modules

Overview A–45

Modules of the

MODULAR ANALYTICS EVO SWA system A–45

System specifications A–48

3 Control unit

Components A–53

Software basics A–56

Online Help system A–62

Main menus A–63

4 Core unit

Overview A–71

Specifications A–71

Host interface A–74

Sample racks A–74

Rack movement A–79

Water supply A–94

5 ISE module

Overview A–97

Sampling system components A–101

Reagent system components A–106

ISE measuring system components A–109

Function key area A–111

Technical specifications A–112

6 D module

Overview A–117

Sampling system components A–119

Reagent system components A–123

Reaction disk area components A–128

Reaction cell rinsing and cell blank A–131

Function key area A–133

Technical specifications A–134

7 P module

Overview A–139

Sampling area components A–142

Reagent area components A–146

Reaction disk area components A–149

Function key area A–155

Technical specifications A–156

8 E module

Overview A–161

Reagent area components A–164

Measuring area components A–171

Consumables area components A–179

PreClean area components A–187

Technical specifications A–189

Tubes and cups A–190

Operation Part B

9 Daily operation

Overview B–5

Starting inspection B–6

Power ON B–7

Pre-routine operation B–10

Routine operation B–42

Maintenance B–58

10 Special operation: How to…

Overview B–63

Test: How to… B–63

Sample: How to… B–76

Patient: How to… B–83

Reagent: How to… B–85

Calibration: How to... B–107

QC: How to… B–122

Maintenance: How to… B–131

Module: How to… B–143

Report: How to… B–146

Timer: How to… B–151

Utility: How to… B–156

Roche Diagnostics

6 Operator’s Manual · Version 4.1

MODULAR ANALYTICS EVO SWA

Maintenance Part C

11 General maintenance

Overview C–5

Recommended scheduled maintenance C–20

Combined scheduled maintenance C–24

Instrument care C–29

12 Maintenance actions for control and core units

Maintenance schedule C–39

Daily maintenance C–40

Weekly maintenance C–41

Monthly maintenance C–45

Quarterly maintenance C–48

As needed C–51

13 Maintenance actions ISE module

ISE maintenance schedule C–61

Daily maintenance C–61

Weekly maintenance C–68

Monthly maintenance C–70

Quarterly maintenance C–76

Every 6 months maintenance C–79

As needed maintenance C–86

14 Maintenance actions D module

D module maintenance schedule C–107

Daily maintenance C–108

Weekly maintenance C–119

Monthly maintenance C–127

Quarterly maintenance C–141

As needed maintenance C–143

15 Maintenance actions P module

P module maintenance schedule C–163

Daily maintenance C–164

Weekly maintenance C–176

Monthly maintenance C–178

As needed maintenance C–193

16 Maintenance actions E module

E module maintenance schedule C–227

Daily maintenance C–228

Weekly maintenance C–232

Every 2 weeks maintenance C–246

Quarterly maintenance C–249

As needed maintenance C–252

Troubleshooting Part D

17 Data alarms

Introduction D–7

Data alarm list D–7

Data alarms ISE module D–10

Data alarms D module and P module D–22

Data alarms E module D–37

Data alarms for controls D–53

Data problems without alarm D–58

Rerun list D–61

18 Troubleshooting

General troubleshooting D–65

Instrument troubleshooting D–67

ISE module troubleshooting D–72

D module troubleshooting D–77

P module troubleshooting D–86

E module troubleshooting D–93

Appendix Part E

19 Appendix

Pretreatment reagents

and the PT link function for E module E–5

Product information for E module E–7

Maintenance logs E–13

Glossary Part F

Glossary F–3

Index Part G

Index G–3

Notes Part H

Roche Diagnostics

Operator’s Manual · Version 4.1 7

MODULAR ANALYTICS EVO SWA

Preface

Intended Use The MODULAR ANALYTICS EVO SWA system is a fully automated, random-

access, software-controlled system for immunoassay and photometric analysis

intended for qualitative and quantitative in vitro determinations using a wide variety

of tests. The MODULAR ANALYTICS EVO SWA system is a powerful tool for

complete diagnostic laboratory automation. It is optimized for high throughput

workloads using a combination of an ion selective electrode module (ISE), 2 types of

photometric analysis modules (D and P), and an immunoassay analysis module (E).

The MODULAR ANALYTICS EVO SWA is a fully automated system for

immunological and photometric analysis. It is important that the operator read this

manual thoroughly before using the system.

This manual has detailed descriptions of MODULAR ANALYTICS EVO SWA

features and general operational concepts, specification functions and use of controls,

operating techniques, emergency procedures, product labeling and maintenance

procedures.

How to use this manual

To help you find information quickly, there is a table of contents at the beginning of

the book and each chapter. In addition, a complete index can be found at the end.

o If the equipment is used in a manner not specified by the manufacturer, the protection

provided by the equipment may be impaired.

o Keep this Operator’s Manual in a safe place to ensure that it is not damaged and

remains available for use.

o This Operator’s Manual should be easily accessible at all times.

MODULAR ANALYTICS EVO SWA

Roche Diagnostics

8 Operator’s Manual · Version 4.1

Where to find information

In addition to the Operator’s Manual, the following documents are also provided to

assist in finding desired information quickly:

The following documents are provided to assist in finding desired information

quickly:

Operator’s Manual Contains information about safety, hardware modules and operating the system as

well as maintenance and troubleshooting. A table of contents at the beginning of the

book and each chapter, and an index at the end of this book help you to find

information quickly.

Online Help Contains a detailed description of the software of the MODULAR ANALYTICS EVO

SWA. In addition to the software description, the whole Operator’s Manual is

embedded into the Online Help. This makes it possible to retrieve information from

both Online Help and Operator’s Manual using the search functions available for

electronically stored documents.

Short Guide The Short Guide is a collection of operations important to routine operation

presented in a practical, easy-to-use format.

COBI-CD The COBI-CD (Compendium of Background Information) provides you with

background information about the technologies, test principles, their theory and

calibration methods used by MODULAR ANALYTICS EVO SWA. It also provides a

complete glossary. The information can be read and printed using Adobe Acrobat

Reader.

Online Help System

MODULAR ANALYTICS EVO SWA has a context sensitive online Help feature to

aid in operating MODULAR ANALYTICS EVO SWA. “Context sensitive” means

that wherever you are located within the MODULAR ANALYTICS EVO SWA

software, choosing the Help feature displays Help text or a screenshot relating to that

area of the software. The online Help offers a quick and convenient way to find

information, such as explanations of screens and dialog boxes and how to perform

particular processes. MODULAR ANALYTICS EVO SWA offers two sources of

online information, F1 Help and Direct.

F1 Help There are two main entry points for the online Help: a context sensitive entry via the

Help buttons in the software or F1 on the keyboard, or the main entry via the Help

icon in the bottom left of the screen. The context sensitive entry displays text or a

screenshot relating to your current location in the software.

Direct Help MODULAR ANALYTICS EVO SWA also offers Direct Help. Direct Help provides

you with information about an element on the screen without having to leave the

software. Direct Help is accessed via the direct help icon positioned to the right of the

guidance prompt.

You cannot use the COBI-CD on the MODULAR ANALYTICS EVO SWA system because the

COBI-CD requires Adobe Acrobat Reader to be viewed correctly. Adobe Acrobat Reader is not

installed on the control unit and must not be installed.

Roche Diagnostics

Operator’s Manual · Version 4.1 9

MODULAR ANALYTICS EVO SWA

Customer information

Customer training Contact your local Roche service representative for any questions or information

regarding MODULAR ANALYTICS EVO SWA system training.

Contact customer service Contact your local Roche service representative for further information regarding the

MODULAR ANALYTICS EVO SWA system service agreement.

Ordering information Replacement parts, consumable materials, reagents, calibrators and controls should

be ordered from Roche Diagnostics. When ordering, please use the Roche

Diagnostics catalog number and reference name for each item. Contact your local

Roche service representative for the detailed ordering list.

MODULAR ANALYTICS EVO SWA

Roche Diagnostics

10 Operator’s Manual · Version 4.1

Symbols and abbreviations

Visual cues are used to help locate and interpret information in this manual quickly.

This section explains formatting conventions used in this manual.

Symbols The following symbols are used:

Abbreviations The following abbreviations are used:

Symbol Used for

a Start of procedure

End of procedure

o List item

e

Cross-reference

h Call-up (software reference)

Tip

Safety alert

Laser Radiation

Biohazard

Electrical hazard

Electrical and electronic equipment marked with this symbol are

covered by the European directive WEEE.

The symbol denotes that the equipment must not be disposed of in

the municipal waste system.

Abbreviation Definition

A

ANSI American National Standards Institute

B

BTS barcode transfer sheet

C

CBT Computer based training

cc cubic centimeter

CLAS 2 Clinical Laboratory Automation System 2

CLIA Clinical Laboratory Improvement Amendments

COBI-CD compendium of background information

CSA Canadian Standards Association

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Operator’s Manual · Version 4.1 11

MODULAR ANALYTICS EVO SWA

D

dBA decibel weighted against the A-frequency response curve. This curve

approximates the audible range of the human ear.

DIL diluent

E

EC European community

ECL electrochemiluminescence

e.g. exempli gratia – for example

EMC electromagnetic compatibility

EN European standard

F

FIFO First in first out

H

HCFA Health Care Financing Administration

I

i.e. id est – that is to say

IEC International Electrical Commission

IS Internal Standard (ISE module)

ISE ion selective electrode

IVD In vitro Diagnostic Directive

K

KVA kilovolt-Ampere. Unit for expressing rating of AC electrical

machinery.

L

LDL see analytical sensitivity lower detection limit

LIS Laboratory Information System

LLD liquid level detection

M

MBC matrix barcode

MSDS material safety data sheet

N

n/a not applicable

NCCLS National Committee for Clinical Laboratory Standards

P

PC/CC ProCell M/CleanCell M

PW PreClean solution PreWash

Q

QC Quality control

R

REF Reference solution for ISE module

Abbreviation Definition

MODULAR ANALYTICS EVO SWA

Roche Diagnostics

12 Operator’s Manual · Version 4.1

S

SD standard deviation

SIP ISE sipper syringe

SVGA Super Video Graphics Adapter

SWA Serum Work Area

T

TPA tripropylamine

U

UL Underwriters Laboratories Inc.

V

VDE Association of German Electrical Engineers (Verband Deutscher

Elektrotechniker)

Abbreviation Definition

1 Safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

2 Overview modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-43

3 Control unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-51

4 Core unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-69

5 ISE module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-95

6 D module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-115

7 P module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-137

8 E module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-159

System description

A

Roche Diagnostics

Operator’s Manual · Version 4.1 A-3

MODULAR ANALYTICS EVO SWA 1 Safety information

Table of contents

Safety information

Before operating with the MODULAR ANALYTICS EVO SWA it is essential that the

warnings, cautions, and safety requirements contained in this manual are read and

understood by the user.

Safety classifications ........................................................................................................ A-5

Safety precautions ........................................................................................................... A-6

Operator qualification .............................................................................................. A-6

Safe and proper use of the instrument ................................................................... A-6

Miscellaneous safety precautions ............................................................................ A-8

Safety summary ............................................................................................................... A-9

Warning messages .................................................................................................... A-9

Electrical safety .................................................................................................... A-9

Biohazardous materials ...................................................................................... A-9

Reagents and other working solutions .......................................................... A-10

Barcode reader .................................................................................................. A-11

Waste .................................................................................................................. A-11

Flammable substances ...................................................................................... A-12

Caution messages .................................................................................................... A-12

Mechanical safety .............................................................................................. A-12

Rack transfer mechanism ................................................................................ A-13

Reagents and other working solutions .......................................................... A-13

Insoluble contaminants in samples ................................................................ A-13

Foam, bubbles or films on sample .................................................................. A-14

Evaporation of samples or reagents ............................................................... A-14

Sample mismatch (non-barcode mode) ........................................................ A-14

Cross contamination of samples .................................................................... A-14

Definition of sample cup size .......................................................................... A-14

Temperature of the incubator and the reagents ........................................... A-15

Aspiration of air ................................................................................................ A-15

ProCell M/CleanCell M reservoirs ................................................................. A-15

Data security ...................................................................................................... A-16

Electromagnetic devices ................................................................................... A-16

Fatigue due to long hours of operation ......................................................... A-16

Spillage ............................................................................................................... A-17

In this chapter

Chapter

1

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A-4 Operator’s Manual · Version 4.1

1 Safety information MODULAR ANALYTICS EVO SWA

Table of contents

Instrument unused for a long period of time ............................................... A-17

Notice ....................................................................................................................... A-18

Moving parts ..................................................................................................... A-18

Powering-on and starting analysis ................................................................. A-18

Cleaning solvents .............................................................................................. A-18

Processing STAT samples ................................................................................ A-18

Circuit breakers and fuses ............................................................................... A-19

Data loss ............................................................................................................. A-19

Safety labels of the system ............................................................................................ A-20

Label description ..................................................................................................... A-20

Control unit ............................................................................................................. A-22

Core unit .................................................................................................................. A-23

ISE module ............................................................................................................... A-27

D module .................................................................................................................. A-30

P module .................................................................................................................. A-34

E module .................................................................................................................. A-37

Peripheral device connections .............................................................................. A-41

Disposal of the instrument ........................................................................................... A-42

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Operator’s Manual · Version 4.1 A-5

MODULAR ANALYTICS EVO SWA 1 Safety information

Safety classifications

This section explains how precautionary information is formatted in the manual.

e

See Safety labels of the system on page A-20.

The safety precautions and important user notes are classified according to

ANSI Z535 standards. Familiarize yourself with the following meanings and icons:

These symbols and signal words are used for specific hazards:

Important information which is not safety relevant is indicated by the following

symbol:

Safety alert symbol

o The safety alert symbol by itself (without a signal word) is used to promote awareness

to hazards which are generic or to direct the reader to safety information provided

elsewhere in the document.

WARNING

Warning

o Indicates a hazardous situation which, if not avoided, could result in death or serious

injury.

CAUTION

Caution

o Indicates a hazardous situation which, if not avoided, could result in minor or moderate

injury.

NOTICE NOTICE

o Indicates a hazardous situation which, if not avoided, may result in property damage.

TIP

o Indicates additional information on correct use of the system or useful tips.

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A-6 Operator’s Manual · Version 4.1

1 Safety information MODULAR ANALYTICS EVO SWA

Safety precautions

Operator qualification

Operators are required to have a sound knowledge of relevant guidelines and

standards as well as the information and procedures contained in the Operator’s

Manual.

o Do not carry out operation and maintenance unless you have been trained by

Roche Diagnostics.

o Carefully follow the procedures specified in the Operator’s Manual for the

operation and maintenance of the system.

o Leave maintenance, installation or service that is not described in the Operator’s

Manual to trained Roche service personnel.

o Follow standard laboratory practices, especially when working with biohazardous

material.

Safe and proper use of the instrument

Keep in mind that the hazard warnings in this manual and on the instrument cannot

cover every possible case, as it is impossible to predict and evaluate all circumstances

beforehand.

Just following the given directions therefore may be inadequate for operation. Always

be alert and use your common sense.

Personal protective equipment Before performing routine operation or any maintenance, be sure to wear

appropriate protective equipment, including, but not limited to, safety glasses with

side shields, fluid resistant lab coat, and approved disposable gloves.

o Wear a face shield if there is a chance of splash or splatter.

Accuracy/precision of measured

results

An incorrect result may lead to an error in diagnosis, therefore posing danger to the

patient.

o For proper use of the instrument, measure control samples and monitor the

instrument during operation.

o Do not use reagents, calibrators, or quality controls that have exceeded their

expiration dates. Observe the specified storage conditions. Otherwise, inaccurate

results may be obtained.

o For diagnostic purposes always assess the results in conjunction with the patient's

medical history, clinical examination and other findings.

Particular attention

o Particular attention must be paid to the following safety precautions. If these safety

precautions are ignored, the operator may suffer serious or fatal injury. Each

precaution is important.

Roche Diagnostics

Operator’s Manual · Version 4.1 A-7

MODULAR ANALYTICS EVO SWA 1 Safety information

Safety precautions

Installation o Installation must be performed by trained Roche Diagnostics service personnel

only.

o Leave installation that is not described in the Operator's Manual to trained Roche

Diagnostics service personnel. Follow the described installation instructions

carefully.

Operating conditions o Operation outside of the specified ranges may lead to incorrect results or

malfunction of the instrument. Never modify the instrument.

o Use the instrument indoors only and avoid heat and humidity.

o Make sure that the instrument's ventilation openings remain unobstructed at all

times.

o Daily maintenance, air ventilation, and accessibility to the breaker require a space

of 1 m at the front and 50 cm at each side and the rear of the analyzer.

Do not occupy such space with obstacles.

o Perform maintenance according to the specified intervals to maintain the

operating conditions of the instrument.

o Keep the Operator’s Manual in a safe place to ensure that it is not damaged and

remains available for use. This manual must be easily accessible at all times.

Handling of reagents and other

working solutions

o Reagents, calibrators and controls must be handled, stored and disposed of

according to the instructions given in the instructions for use.

o Samples and chemicals must be handled, stored and disposed of on your own

responsibility and in accordance with the appropriate standards.

Approved parts Use of non-approved parts or devices may result in malfunction of the instrument

and may render the warranty null and void. Only use parts and devices approved by

Roche Diagnostics.

Third-party software Installation of any third-party software that is not approved by Roche Diagnostics

may result in incorrect behavior of the instrument. Do not install any non-approved

software. Do not install a commercially available program into the control unit

computer or change any PC settings.

Roche Diagnostics

A-8 Operator’s Manual · Version 4.1

1 Safety information MODULAR ANALYTICS EVO SWA

Safety precautions

Miscellaneous safety precautions

Power interruption A power failure or momentary drop in voltage or aging of the hard disk may damage

the instrument or lead to data loss. Perform backups of measurement results

periodically. Operate only with an uninterruptible power supply.

Do not switch off power while the PC accesses the hard disk or another storage

medium.

Computer viruses If you register an unexpected operation or program/data damage, the PC may be

infected by a computer virus. Never use a program or storage medium that is

suspected of containing a virus. Before using a removable storage medium, it should

be scanned by an antivirus program.

Instrument unused for an

extended period of time

If the instrument is not used for an extended period of time, the main power must be

switched OFF. Remove, close, and refrigerate any remaining reagents. For further

information, call technical support.

e

For more information, see also:

Instrument unused for a long period of time on page A-17

Power ON procedures on page C-262

Relocation and transportation Do not attempt to relocate or transport the instrument. Leave relocation and

transportation to personnel trained or authorized by Roche Diagnostics.

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