Roche cobas s 201 system User manual

COBAS

®

TaqMan

®

Analyzer

Instrument Manual

Version 2.0

For use with the cobas s 201 system

Operator’s Manual and the

AMPLILINK Software Version 3.3

Series

COBAS

®

TaqMan

®

Analyzer

Roche Diagnostics

2 Instrument Manual · Version 2.0

Document information

Revision history

Edition notice This publication is for users of the COBAS

®

TaqMan

®

Analyzer.

Some of the tests identified for use with the COBAS

®

TaqMan

®

Analyzer may not be

approved for use in all countries. Contact a Roche representative for tests that are

commercially available in your country.

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 reserves the

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

development.

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

agreement null and void.

Software updates are done by Roche Service representatives.

Intended use The COBAS

®

TaqMan

®

Analyzer is an automated amplification and detection system

for nucleic acids using 5' nuclease technology.

The docking station connects the COBAS

®

AmpliPrep Instrument and the COBAS

®

TaqMan

®

Analyzer to fully automate sample preparation, amplification, and

detection.

The COBAS

®

TaqMan

®

Analyzer and docking station are intended to be used by

laboratory professionals trained in laboratory techniques and by instruction on the

use of the system.

This manual is to be used in conjunction with the Instrument Manual for the

COBAS

®

AmpliPrep Instrument and the cobas s 201 system Operator’s Manual.

This manual is not to be used for applications performed using versions of the

AMPLILINK software earlier than 3.3 Series.

Trademarks ROCHE, AMPLILINK, AMPERASE, COBAS, AMPLIPREP, TAQMAN, and

COBAS S are trademarks of Roche.

Microsoft and Windows are either registered trademarks or trademarks of Microsoft

Corporation in the United States and/or other countries.

Manual Version Software Version Revision date Changes

1.0 3.2 March 2007

1.1 3.3 August 2010 Update to Roche Corporate

Identity and AMPLILINK

software version 3.3

1.2 3.3 February 2013 Address change

Update laser information and

warnings

Cleaning procedures updated

General changes and

adaptations

2.0

3.3 September 2014 Support for PDM SW4.0.

Roche Diagnostics

Instrument Manual · Version 2.0 3

COBAS

®

TaqMan

®

Analyzer

Instrument approvals The COBAS® TaqMan® Analyzer meets the protection requirements laid down in

Directive 98/79/EC of the European Parliament and of the Council of 27 October

1998 on In-vitro Diagnostics Medical Devices. Compliance is provided by means of

the Declaration of Conformity.

Regulatory compliance is demonstrated by the following marks:

Contact addresses

Complies with the IVD directive 98/79/EC.

CUS

®

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

US.

Roche Molecular Systems, Inc.

1080 US Highway 202 South

Branchburg, NJ 08876

USA

Made in Switzerland

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

COBAS

®

TaqMan

®

Analyzer

Roche Diagnostics

4 Instrument Manual · Version 2.0

Roche Diagnostics

Instrument Manual · Version 2.0 5

COBAS

®

TaqMan

®

Analyzer

Table of contents

Document information 2

Contact addresses 3

Table of contents 5

Preface 7

How to use this manual 7

Conventions used in this manual 8

System Description Part A

1 General safety information

Safety classifications A–5

Safety precautions A–6

Safety summary A–8

Safety labels on the system A–13

Disposal of the analyzer A–16

2 Overview

Technical specifications A–19

Installation A–21

3 Instrument

Methodology A–27

Covers and panels A–29

LEDs A–33

Work area A–34

Hardware overview A–35

Operation Part B

4Operation

Overview B–5

Safety information B–5

Workflow B–6

Setup and operation B–7

Maintenance Part C

5Service

Overview C–5

Safety information C–5

General cleaning C–7

Daily maintenance C–9

Periodic maintenance C–10

Troubleshooting Part D

6 Troubleshooting

Overview D–5

Error messages D–7

Glossary and Index Part E

Glossary E–3

Index E–5

Revisions Part F

Roche Diagnostics

6 Instrument Manual · Version 2.0

COBAS

®

TaqMan

®

Analyzer

Roche Diagnostics

Instrument Manual · Version 2.0 7

COBAS

®

TaqMan

®

Analyzer

Preface

The COBAS

®

TaqMan

®

Analyzer is an automated amplification and detection system

for nucleic acids using 5' nuclease technology.

The docking station connects the COBAS

®

AmpliPrep Instrument and the COBAS

®

TaqMan

®

Analyzer to fully automate sample preparation, amplification, and

detection.

The COBAS

®

TaqMan

®

Analyzer and docking station are intended to be used by

laboratory professionals trained in laboratory techniques and by instruction on the

use of the system.

This manual is to be used in conjunction with the Instrument Manual for the

COBAS

®

AmpliPrep Instrument and the cobas s 201 system Operator’s Manual.

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.

The Instrument Manual for the COBAS

®

TaqMan

®

Analyzer contains the following

chapters:

Preface Summarizes the conventions used in this manual.

Safety Summarizes safety precautions that are necessary when installing, operating, and

servicing the analyzer.

Overview Provides an introduction to the COBAS

®

TaqMan

®

Analyzer and docking station. The

analyzer specifications and procedures for installation and setup of the analyzer are

described.

Instrument Describes the COBAS

®

TaqMan

®

Analyzer in detail. The major components of the

analyzer are listed, and the function and operation of each component is described.

Operation Outlines the procedures used during routine operation of the COBAS

®

TaqMan

®

Analyzer.

Service Reviews the steps required for regular service of the COBAS

®

TaqMan

®

Analyzer.

Troubleshooting Describes the procedures for resolving problems during operation.

Glossary and Index Provides reference and look-up material.

NOTICE

o This manual is only to be used in combination with AMPLILINK software version 3.3

Series.

o This manual is not to be used for applications performed using versions of the

AMPLILINK Software earlier than 3.3 Series.

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

remains available for use.

o This Instrument Manual should be easily accessible at all times.

COBAS

®

TaqMan

®

Analyzer

Roche Diagnostics

8 Instrument Manual · Version 2.0

Conventions used in this manual

This section explains the formatting conventions used in this manual.

Text conventions To convey information readily and consistently, certain text conventions are used

throughout this manual. These text conventions are as follows:

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

The following symbols are used:

Screen shots The screen representations shown in this publication are for illustrative purposes

only. The screens do not necessarily show valid data.

Text convention Used for

Numbered lists

Numbered procedures that should be implemented sequentially

during an operation:

1

Turn power switch on.

2

Click File.

Italics

Designating another section of this manual that should be consulted:

e

For additional details, see To perform daily maintenance on

page C-9

>

Separates command options in a multi-level command:

Select File > Shut Down from the menu bar.

Symbol Used for

a Start of procedure

End of procedure

o List item

e

Cross-reference

Tip

Danger alert symbol

Warning alert symbol

Caution and general safety alert symbol

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.

Global Trade Item Number. Used on the type plate of the instrument.

Roche Diagnostics

Instrument Manual · Version 2.0 9

COBAS

®

TaqMan

®

Analyzer

Units The following measurement abbreviations are used:

cm Centimeters

Hz Hertz

in Inches

kg Kilograms

lb Pounds (weight)

VA Volt-Ampères (power consumption)

VAC Volts (alternating current)

COBAS

®

TaqMan

®

Analyzer

Roche Diagnostics

10 Instrument Manual · Version 2.0

1 General safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

2 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-17

3 Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-25

System Description

A

Roche Diagnostics

Instrument Manual · Version 2.0 A-3

COBAS

®

TaqMan

®

Analyzer 1 General safety information

Table of contents

General safety information

In this chapter, you will find information on the safe operation of the COBAS

®

TaqMan

®

Analyzer.

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

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

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

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

Miscellaneous safety precautions ............................................................................ A-7

Safety summary ............................................................................................................... A-8

Warning messages .................................................................................................... A-8

Electrical safety .................................................................................................... A-8

Optical safety ....................................................................................................... A-8

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

Waste .................................................................................................................... A-9

Explosion and fire risk ..................................................................................... A-10

Caution messages .................................................................................................... A-11

Mechanical safety .............................................................................................. A-11

Insoluble contaminants in samples ................................................................ A-11

Notices ...................................................................................................................... A-12

Moving parts ..................................................................................................... A-12

Circuit breakers and fuses ............................................................................... A-12

Spillage ............................................................................................................... A-12

Safety labels on the system ........................................................................................... A-13

Safety information for laser transmitter .............................................................. A-14

Disposal of the analyzer ............................................................................................... A-16

In this chapter

Chapter

1

Roche Diagnostics

A-4 Instrument Manual · Version 2.0

1 General safety information COBAS

®

TaqMan

®

Analyzer

Table of contents

Roche Diagnostics

Instrument Manual · Version 2.0 A-5

COBAS

®

TaqMan

®

Analyzer 1 General safety information

Safety classifications

This section explains how precautionary information is presented in this manual.

The safety precautions and important user notes are classified according to the

ANSI Z535.6 Standard. Familiarize yourself with the following icons and their

meanings:

These symbols and signal words are used for specific hazards:

e

For more information about the product safety labels, see Safety labels on the system on

page A-13

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

symbol:

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.

DANGER

Indicates a hazardous situation which, if not avoided, will result in death or serious injury.

WARNING

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

injury.

CAUTION

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

injury.

NOTICE

Indicates a hazardous situation which, if not avoided, could result in damage to equipment.

Tip

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

Roche Diagnostics

A-6 Instrument Manual · Version 2.0

1 General safety information COBAS

®

TaqMan

®

Analyzer

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 Instrument

Manuals.

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

o Carefully follow the procedures specified in the Instrument Manuals for the

operation and maintenance of the analyzer.

o Leave maintenance, installation, or service that is not described in the Instrument

Manuals to trained Roche Service personnel.

o Follow standard laboratory practices, especially when working with biohazardous

material.

Safe and proper use of the analyzer

Personal protective equipment o Be sure to wear appropriate protective equipment, including, but not limited to,

safety glasses with side shields, 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 measuring result may lead to an error in diagnosis, therefore posing

danger to the patient.

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

during operation.

o Do not use reagents and consumables that have exceeded their expiration date,

otherwise inaccurate data may be obtained.

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

medical history, clinical examination, and other findings.

o Each laboratory must verify that analyzer and reagent performance meets the

published specifications.

Installation o Installation must be performed by trained Roche Service personnel only.

o Leave installation that is not described in the Instrument Manuals to trained

Roche Service personnel. Follow the described installation instructions carefully.

Correct use Use the COBAS

®

TaqMan

®

Analyzer only for measuring liquid samples with the

provided reagents.

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

Instrument Manual · Version 2.0 A-7

COBAS

®

TaqMan

®

Analyzer 1 General safety information

Safety precautions

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

malfunction of the analyzer (see Technical specifications on page A-19).

o Use the analyzer indoors only and avoid heat and humidity (see Technical

specifications on page A-19).

o Make sure that the analyzer’s ventilation openings remain unobstructed at all

times.

o Perform maintenance according to the specified intervals to maintain the

operating conditions of the analyzer.

o Keep the Instrument 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.

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

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

Roche Diagnostics.

Miscellaneous safety precautions

Power interruption A power failure or momentary drop in voltage may damage the analyzer or lead to

data loss. Perform regularly backups of measurement results. Operation with an

uninterruptible power supply (UPS) is recommended.

Electromagnetic fields Do not use this device in close proximity to sources of strong electromagnetic

radiation (e.g. unshielded intentional RF sources), as these can interfere with the

proper operation.

Relocation and transportation Do not attempt to relocate or transport the analyzer or docking station. Leave

relocation and transportation to personnel trained or authorized by Roche.

e

For additional details, see Disposal of the analyzer on page A-16

Roche Diagnostics

A-8 Instrument Manual · Version 2.0

1 General safety information COBAS

®

TaqMan

®

Analyzer

Safety summary

This safety summary contains the most important general warning and caution

messages. Additionally, you will find specific safety information at the beginning of

Chapter Operation and Chapter Service

.

Warning messages

Electrical safety

Optical safety

WARNING

List of warning messages

Before operating the analyzer, read the warning messages contained in this summary

carefully. Failure to observe them may result in death or serious injury.

Electrical shock by electronic equipment

o Do not attempt to work in any electronic compartment.

o Do not remove any cover of the analyzer other than those specified in this Instrument

Manual.

o Do not open the side panels while the analyzer is connected to the power supply.

o Do not touch any parts of the analyzer other than those specified. Especially do not

touch any power supply parts.

o Never remove the middle grounding prong from the power cable or defeat its purpose

by using an ungrounded adapter.

o Installation, service, and repair must only be performed by personnel authorized and

qualified by Roche.

o Observe the system safety labels as illustrated in section Safety labels on the system on

page A-13.

Loss of sight due to staring into laser beam

The on-board barcode reader contains a class 2 laser diode.

Do not stare into the laser transmitter beam as your eyesight may be severely damaged.

e

For position of the laser transmitter, see Safety information for laser transmitter on

page A-14

Damage to the eyes due to staring into light of the fluorometer lamp

Looking into the light of the fluorometer lamp may severely damage your eyesight.

Always wear dark safety glasses when looking at the light of the fluorometer lamp.

Roche Diagnostics

Instrument Manual · Version 2.0 A-9

COBAS

®

TaqMan

®

Analyzer 1 General safety information

Safety summary

Biohazardous materials

Waste

e

For information about disposal of the analyzer, see Disposal of the analyzer on page A-16

Infection by samples and associated materials

Samples analyzed with this analyzer are treated to inactivate potentially biohazardous

material. However, as with all human-derived specimens, universal precautions should be

taken when handling and processing samples.

Contact with samples containing material of human origin may result in infection. All

materials and mechanical components associated with samples of human origin are

potentially biohazardous.

o Follow standard laboratory practices, especially when working with biohazardous

material.

o Keep the main cover and the load panel closed and in place while the analyzer is

operating.

o When working with open main cover while the analyzer is powered on (e.g. for

cleaning or maintenance), always put the analyzer in Maintenance mode or in

Shutdown status first.

o Be sure to wear appropriate protective equipment, including, but not limited to, safety

glasses with side shields, lab coat, and approved disposable gloves.

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

o If any biohazardous material is spilled, wipe it up immediately and apply disinfectant.

See General cleaning on page C-7 for additional cleaning recommendation.

o If sample or waste solution comes into contact with your skin, immediately apply

disinfectant, and then wash it off with soap and water. Consult a physician.

Infection by biohazardous waste

Contact with waste may result in infection. All materials and mechanical components

associated with the waste systems are potentially biohazardous.

o Be sure to wear protective equipment. Take extra care when working with protective

gloves; these can easily be pierced or cut which can lead to infection.

o If any biohazardous material is spilled, wipe it up immediately and apply disinfectant.

o If waste solution comes into contact with your skin, wash it off immediately with water

and apply a disinfectant. Consult a physician.

o Observe the system safety labels as illustrated in section Safety labels on the system on

page A-13.

Contamination of the environment by waste solution and solid waste

The waste of the analyzer is potentially biohazardous.

o When disposing of any waste generated by the analyzer, do so according to the

appropriate local regulations.

Roche Diagnostics

A-10 Instrument Manual · Version 2.0

1 General safety information COBAS

®

TaqMan

®

Analyzer

Safety summary

Explosion and fire risk

Explosion through sparks

Hazard of explosion through sparks.

o Keep all potentially flammable or explosive material (e.g. anesthetic gas) away from the

analyzer.

Fire risk through usage of sprays

Spraying liquid on the power supply parts can cause a short circuit and result in a fire.

o Keep the cover closed while the analyzer is connected to the main power supply, and

do not use sprays in the vicinity of the analyzer.

o During fire-fighting operations disconnect the COBAS

®

TaqMan

®

Analyzer from the

main power supply.

Page is loading ...

Roche cobas s 201 system User manual

Roche cobas s 201 system User manual

Related papers

Other documents