Roche COBAS TaqMan User manual

COBAS

®

TaqMan

®

Analyzer

Instrument Manual

Version 3.0

For use with the AMPLILINK Software, Version 3.4.2

COBAS® TaqMan® Analyzer

Roche Diagnostics

2 Instrument Manual · Version 3.0

Publication information

Edition notice

This publication is intended for operators 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

publication is correct at the time of publishing. However, Roche Molecular Systems,

Inc. may need to update the publication information as output of product

surveillance activities, leading to a new version of this publication.

Where to find information The Instrument Manual contains all information about the product, including the

following:

o Routine operation

o Maintenance

o Safety

o Troubleshooting information

o A software reference

o Configuration information

o Background information

CAUTION

General attention

To avoid serious or fatal injury, ensure that you are familiar with the system and safety

information before you use the system.

r Pay particular attention to all safety precautions.

r Always follow the instructions in this publication.

r Do not use the instrument in a way that is not described in this publication.

r Store all publications in a safe and easily accessible place.

Training Do not carry out operation tasks or maintenance actions unless you have received

training from Roche Diagnostics. Leave tasks that are not described in the user

documentation to trained Roche Service representatives.

Publication

version

Software version Revision date Change description

1.0 3.2 March 2007

1.1 3.2 and 3.3 September 2008 Update to Roche Corporate Identity and AMPLILINK Software

Version 3.3 Series

1.2 3.2 and 3.3 November 2012 Address change

Update laser information and warnings

Cleaning procedures updated

General changes and adaptations

1.3 3.2 and 3.3 June 2013 Hardware error messages updated

2.0 3.3 and 3.4 June 2015 Update to AMPLILINK Software Version 3.4 Series

3.0 3.3 and 3.4 January 2020

u What is new in Instrument Manual version 3.0 (p. 11)

Table 1 Revision history

Roche Diagnostics

Instrument Manual · Version 3.0 3

COBAS® TaqMan® Analyzer

Images The screenshots and hardware images in this publication have been added exclusively

for illustration purposes. Configurable and variable data in screenshots, such as tests,

results, or path names visible therein must not be used for laboratory purposes.

Warranty Any customer modification to the system renders the warranty or service agreement

null and void.

For conditions of warranty, contact your local sales representative or refer to your

warranty contract partner.

Always leave software updates to a Roche Service representative or perform such

updates with their assistance.

License information

COBAS

®

TaqMan

®

Analyzer software is protected by contract law, copyright law, and

international treaties. COBAS

®

TaqMan

®

Analyzer contains a user license between F.

Hoffmann-La Roche Ltd. and a license holder, and only authorized users may access

the software and use it. Unauthorized use and distribution may result in civil and

criminal penalties.

Open-source and commercial

software

COBAS

®

TaqMan

®

Analyzer may include components or modules of commercial or

open-source software. For further information on the intellectual property and other

warnings, as well as licenses pertaining to the software programs included in

COBAS

®

TaqMan

®

Analyzer, refer to the electronic distribution included with this

product.

This open-source and commercial software and COBAS

®

TaqMan

®

Analyzer as a

whole can constitute a device regulated in accordance with applicable law. For more

detailed information, refer to the corresponding user documentation and labeling.

Note that the respective authorization is no longer valid according to the

corresponding legislation should any unauthorized changes be made to

COBAS

®

TaqMan

®

Analyzer.

Trademarks The following trademarks are acknowledged:

AMPERASE, AMPLILINK, AMPLIPREP, COBAS, and TAQMAN are trademarks of

Roche.

All other trademarks are the property of their respective owners.

Feedback Every effort has been made to ensure that this publication fulfills the intended use. All

feedback on any aspect of this publication is welcome and is considered during

updates. Contact your Roche representative, should you have any such feedback.

Approvals

The COBAS

®

TaqMan

®

Analyzer meets the requirements laid down in:

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

1998 on in vitro diagnostic medical devices.

Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011

on the restriction of the use of certain hazardous substances in electrical and

electronic equipment.

Compliance with the applicable directive(s) is provided by means of the Declaration

of Conformity.

The following marks demonstrate compliance:

COBAS® TaqMan® Analyzer

Roche Diagnostics

4 Instrument Manual · Version 3.0

Lead This product includes an internal constituent containing a Substance of Very High

Concern (SVHC), Lead (CAS 7439-92-1), in a concentration above 0.1% weight by

weight, as identified under REACH and added to the Candidate List.

There is no direct exposure to the substance when the instrument is operated

according to the instructions for use.

Contact addresses

For in vitro diagnostic use.

Complies with the provisions of the applicable EU directives.

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

the US.

CUS

®

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

Roche Diagnostics

Instrument Manual · Version 3.0 5

COBAS® TaqMan® Analyzer

Table of contents

Publication information 2

Contact addresses 4

Table of contents 5

Intended use 7

Symbols 7

What is new in Instrument Manual version 3.0 8

What is new in Instrument Manual version 2.0 8

System description

1 General safety information

Safety classifications 13

Safety precautions 14

Safety summary 16

Safety labels on the system 20

Disposal of the analyzer 23

2 Overview

Housing 27

Technical specifications 28

Installation 30

3 Instrument

Methodology 37

Covers and panels 39

LEDs 43

Work area 44

Hardware overview 45

Operation

4 Operation

Overview 55

Safety information 56

Workf low 57

Setup and operation 58

Maintenance

5 Service

Overview 65

Safety information 66

General cleaning 67

Daily maintenance 69

Periodic maintenance 70

Replacing the fan filters 76

Replacing the lamp 78

Troubleshooting

6 Troubleshooting

Overview 85

Error messages 87

Glossary

7 Glossary

Index

Index 95

Revisions

Roche Diagnostics

6 Instrument Manual · Version 3.0

COBAS® TaqMan® Analyzer

Roche Diagnostics

Instrument Manual · Version 3.0 7

COBAS® TaqMan® Analyzer

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 Application Manual for the AMPLILINK

Software Version 3.4.2.

NOTICE

Notice

r This manual is only to be used for COBAS

®

TaqMan

®

Analyzer with serial number

≥ 450001.

r This manual is only to be used in combination with AMPLILINK Software Version 3.4.2.

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

AMPLILINK Software earlier than 3.4.2 Series.

Symbols

Symbols used in the publication

GTIN icon used on the instrument

Symbol Explanation

p Start of procedure

s End of procedure

o List item

u Cross-reference

q Tip

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.

Table 2 Symbols used in the publication

Symbol Explanation

Global Trade Item Number

Table 3 GTIN icon used on the instrument

COBAS® TaqMan® Analyzer

Roche Diagnostics

8 Instrument Manual · Version 3.0

What is new in Instrument Manual version 3.0

Main cover When opening the main cover, the analyzer is automatically powered off. After

closing the main cover, the analyzer is powered on again and initializes.

All instructional information in this publication has been adapted accordingly.

Access protection Access protection has been improved by introducing several safety switches, an

interlock functionality on the power supply, and access protection flaps at the

entrance of the sample rack loading area.

Lead A REACH statement about lead was added.

u Lead (p. 4)

Shar ps, rough edges, and/or

moving parts

A warning statement about sharps, rough edges, and/or moving parts was added.

u Sharps, rough edges, and/or moving parts (p. 16)

Laser class 1 The laser transmitter of the barcode scanner on the rack platform is now classified as

IEC 60825-1 class 1 laser product and is less harmful. Consequently, all warning

statements about the loss of sight due to staring into the laser beam have been

removed.

COBAS

®

Taq Man

®

48 Analyzer

All information related to the COBAS

®

TaqMan

®

48 Analyzer has been removed from

this publication. The AMPLILINK Software Version 3.4.2 is not compatible with the

COBAS

®

TaqMan

®

48 Analyzer.

Compatibility o This publication is only to be used for COBAS

®

TaqMan

®

Analyzer with serial

number ≥ 450001.

o This publication is only to be used in combination with AMPLILINK Software

Version 3.4.2.

What is new in Instrument Manual version 2.0

Changes in the fro nt mat ter and

preface

o Front matter and preface have been updated according to the new Roche

Diagnostics standards.

o Company name adapted in copyright information.

o GTIN (Global Trade Item Number) symbol added to the list of symbols.

Error messages Hardware error messages updated.

u For details, see H ardware error messages (p. 87)

General changes in this doc ument o AMPLILINK Software Version updated: 3.2 Series deleted and 3.4 Series added.

o Term “data station” replaced with “control unit”.

o Any reference to the COBAS

®

AMPLICOR

®

removed.

o Information about the Windows operating system adapted.

System description

1 General safety information .............................................................................................................. 11

2 Overview .......................................................................................................................................... 25

3 Instrument........................................................................................................................................ 35

Roche Diagnostics

Instrument Manual · Version 3.0 11

COBAS® TaqMan® Analyzer 1 General safety information

Table of co nte nts

General safety information 1

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

COBAS

®

TaqMan

®

Analyzer.

In this chapter

Chapter

1

Safety classifications.............................................................................................................13

Safety precautions.................................................................................................................14

Operator qualification...................................................................................................14

Safe and proper use of the analyzer .............................................................................14

Miscellaneous safety precautions.................................................................................15

Safety summary ....................................................................................................................16

Warning messages..........................................................................................................16

Sharps, rough edges, and/or moving parts...........................................................16

Electrical safety.........................................................................................................16

Optical safety ............................................................................................................16

Biohazardous materials ...........................................................................................17

Waste..........................................................................................................................17

Explosion and fire risk ............................................................................................17

Caution messages...........................................................................................................18

Mechanical safety.....................................................................................................18

Insoluble contaminants in samples........................................................................18

Notices .............................................................................................................................19

Moving parts.............................................................................................................19

Circuit breakers and fuses.......................................................................................19

Spillage.......................................................................................................................19

Safety labels on the system ..................................................................................................20

Safety information for laser transmitter......................................................................22

Disposal of the analyzer.......................................................................................................23

Roche Diagnostics

12 Instrument Manual · Version 3.0

1 General safety information COBAS® TaqMan® Analyzer

Table of co nte nts

Roche Diagnostics

Instrument Manual · Version 3.0 13

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:

Generic safety precaution

r 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.

These symbols and signal words are used for specific hazards:

WARNING

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

injury.

CAUTION

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

injury.

NOTICE

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

equipment.

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

(p. 20)

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

symbol:

q

Tip

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

Roche Diagnostics

14 Instrument Manual · Version 3.0

1 General safety information COBAS® TaqMan® Analyzer

Safety precautions

Generic safety precaution

r 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.

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 and

Application Manuals.

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

o Carefully follow the procedures specified in the Instrument and Application

Manuals for the operation and maintenance of the analyzer.

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

and Application 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 and Application

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.

Roche Diagnostics

Instrument Manual · Version 3.0 15

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 (p. 28)).

o Use the analyzer indoors only and avoid heat and humidity (see Tec hnic al

specifications (p. 28)).

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 part s 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.

u For additional details, see Disposal of the analyzer (p. 23)

Roche Diagnostics

16 Instrument Manual · Version 3.0

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 4 Operation (p. 53) and Chapter 5 Service (p. 63).

Warning messages

WARNING

List of warning messages

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

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

Sharps, rough edges, and/or moving parts

WARNING

Personal injury and infection due to sharps, rough edges, and/or moving parts

Good Laboratory Practice can reduce the risk of injury. Be aware of your laboratory

environment, well-prepared, and follow the instructions for use. Some areas of the

instrument may have sharps, rough edges, and/or moving parts.

r Wear personal protective equipment to minimize the risk of injury from bodily contact

with such parts, especially in less accessible areas, or while cleaning the instrument.

r Your personal protective equipment should be appropriate to the degree and type of

potential hazard, e.g. suitable lab gloves, eye protection, lab coat, and footwear.

Electrical safety

WARNING

Electrical shock by electronic equipment

r Do not attempt to work in any electronic compartment.

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

Manual.

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

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

touch any power supply parts.

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

by using an ungrounded adapter.

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

qualified by Roche.

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

(p. 20).

Optical safety

WARNING

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

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

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

Roche Diagnostics

Instrument Manual · Version 3.0 17

COBAS® TaqMan® Analyzer 1 General safety information

Safety summary

Biohazardous materials

WARNING

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.

r Follow standard laboratory practices, especially when working with biohazardous

material.

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

operating.

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

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

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

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

See General cleaning (p. 67) for additional cleaning recommendation.

r 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.

Waste

WARNING

Infection by biohazardous waste

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

associated with the waste systems are potentially biohazardous.

r 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.

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

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

and apply a disinfectant. Consult a physician.

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

(p. 20).

WARNING

Contamination of the environment by waste solution and solid waste

The waste of the analyzer is potentially biohazardous.

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

appropriate local regulations.

u For information about disposal of the analyzer, see Dis po sal of the analyzer (p. 23)

Explosion and fire risk

WARNING

Explosion through sparks

Hazard of explosion through sparks.

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

analyzer.

Roche Diagnostics

18 Instrument Manual · Version 3.0

1 General safety information COBAS® TaqMan® Analyzer

Safety summary

WARNING

Fire risk through usage of sprays

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

r 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.

r During fire-fighting operations disconnect the COBAS

®

TaqMan

®

Analyzer from the

main power supply.

Caution messages

CAUTION

List of caution messages

r Before operating the analyzer, read the caution messages contained in this summary

carefully. Failure to observe them may result in minor or moderate injury.

Mechanical safety

CAUTION

Personal injury due to contact with moving parts

Transfer head moves rapidly during operation. The main cover is locked during operation,

protecting the user from moving parts.

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

operating.

r Keep the docking station front cover closed when operating a docked system.

r Do not touch any parts of the analyzer other than those specified. Keep away from

moving parts during analyzer operation.

r During operation and maintenance of the analyzer, proceed according to the

instructions.

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

(p. 20).

Insoluble contaminants in samples

CAUTION

Incorrect results and interruption of analysis due to samples with insoluble

contaminants

r Insoluble contaminants in samples and bubbles or films inside a sample container may

cause clogging, pipetting volume shortage, or block optical measurements.

r When loading samples on the instrument, make sure they contain no insoluble

contaminants such as fibrin or dust.

Roche Diagnostics

Instrument Manual · Version 3.0 19

COBAS® TaqMan® Analyzer 1 General safety information

Safety summary

Notices

NOTICE

List of notices

r Before operating the analyzer, read the notices contained in this summary carefully.

Failure to observe them may result in damage to equipment.

Moving parts

NOTICE

Damage to the analyzer due to contact with moving parts

Contact with moving parts may damage components.

r Keep all covers closed and in place while the analyzer is operating.

r Do not touch any parts of the analyzer other than those specified. Keep away from

moving parts during analyzer operation.

Circuit breakers and fuses

NOTICE

Damage to the analyzer due to improper use

r Should one of the analyzer circuit breakers or fuses blow, do not attempt to operate the

analyzer before contacting Roche Service.

Spillage

NOTICE

Malfunction due to spilled liquid

Any liquid spilled on the analyzer may result in malfunction or damage of the analyzer.

r Do not place samples, reagents, or any other liquid on the surface of the analyzer.

r If liquid does spill on the analyzer, wipe it up immediately and apply disinfectant. Be

sure to wear protective equipment.

Roche Diagnostics

20 Instrument Manual · Version 3.0

1 General safety information COBAS® TaqMan® Analyzer

Safety labels on the system

Warning labels have been placed on the analyzer to draw your attention to areas of

potential hazard. The labels and their definitions are listed below according to their

location on the analyzer.

The safety labels on the analyzer comply with the following standards: ANSI Z535,

IEC 61010-1, IEC 60417-DB-3M, or ISO 7000.

q

If the labels are damaged, they must be replaced by Roche Service personnel. For

replacement labels contact your local Roche representative.

Safety label on system Location and meaning

Caution

Refer to accompanying documents. The triangular

symbol on the back of the analyzer is a general

reminder that users read the safety information

contained in this manual. Users must be able to

identify specific hazards and take appropriate

action to avoid them.

Refer to the Instrument Manual for instructions

on safe operation.

Laser transmitter warning

Situated behind the load panel to designate the

presence of a laser transmitter.

Do not stare into the laser transmitter.

u For details, see Safety information for laser

transmitter (p. 22)

Laser transmitter warning

Situated on Barcode Scanner to designate the

presence of a laser transmitter.

u For details, see Safety information for laser

transmitter (p. 22)

Warning - Fire Hazard

For continued protection replace only

with same type and rating of fuse

according to the fuse rate label on the

instrument.

Avertissement-Risque d'incendie

Afin d'assurer une protection constante

toujours remettre un fusible du même

calibre.

Electrical warning

Situated on the power supply. Only replace a fuse

with a fuse of the same type and rating.

Refer to the Instrument Manual for instructions

on safe operation.

Table 1-1 Safety labels on the system

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Roche COBAS TaqMan User manual

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