Roche COBAS AMPLIPREP User manual

COBAS

®

AmpliPrep Instrument

Instrument Manual

Version 3.0

For use with the AMPLILINK Software, Version 3.4.2

COBAS® AmpliPrep Instrument

Roche Diagnostics

2 Instrument Manual · Version 3.0

Publication information

Edition notice

This publication is intended for operators of the COBAS

®

AmpliPrep Instrument.

Some of the tests identified for use with the COBAS

®

AmpliPrep Instrument 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.

Publication

version

Software version Revision date Change description

1.0 3.2 March 2007

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

version 3.3

1.2 3.2 and 3.3 May 2012 Laser warning adapted

Previous revisions incorporated

Minor improvements

1.3 3.2 and 3.3 November 2012 Cleaning procedures updated

General changes and adaptions

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

2.1 3.3 and 3.4 July 2018 Front matter and preface updated and expanded

New safety label on the instrument. Additional safety message

New safety labels for laser transmitter warnings

Line voltage and line frequency updated

Tip added to storage shutdown

u What is new in Instrument Manual version 2.1 (p. 10)

3.0 3.4.2 January 2020

u What is new in Instrument Manual version 3.0 (p. 9)

Table 1 Revision history

Roche Diagnostics

Instrument Manual · Version 3.0 3

COBAS® AmpliPrep Instrument

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.

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

®

AmpliPrep Instrument software is protected by contract law, copyright law,

and international treaties. COBAS

®

AmpliPrep Instrument 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 commerc ial

software

COBAS

®

AmpliPrep Instrument 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

®

AmpliPrep Instrument, refer to the electronic distribution included with

this product.

This open-source and commercial software and COBAS

®

AmpliPrep Instrument 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

®

AmpliPrep Instrument.

Trademarks The following trademarks are acknowledged:

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

®

AmpliPrep Instrument 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.

COBAS® AmpliPrep Instrument

Roche Diagnostics

4 Instrument Manual · Version 3.0

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

of Conformity.

The following marks demonstrate compliance:

Fluorinated greenhouse gas The product contains a fluorinated greenhouse gas in the hermetically sealed

refrigeration.

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

Complies with the provisions of the applicable EU directives.

For in vitro diagnostic use.

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

US.

CUS

®

Type Charge weight (kg) CO

2

equivalent

(tonne)

Global warming

potential

R134a 0.200 0.286 1430

Table 2 Fluorinated greenhouse gas detail

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® AmpliPrep Instrument

Table of contents

Publication information 2

Contact addresses 4

Table of contents 5

Intended use 7

Symbols and abbreviations 7

What is new in Instrument Manual version 3.0 9

What is new in Instrument Manual version 2.1 10

What is new in Instrument Manual version 2.0 11

System description

1 General safety information

Safety classifications 17

Safety precautions 18

Safety summary 20

Safety labels on the system 25

Safety information for laser transmitters 27

Disposal of the instrument 28

2 Overview

Housing 31

Technical specifications 32

Installation 34

3 Instrument

Sample preparation overview 41

System overview 42

Covers and panels 43

LEDs 48

Main components 50

Hardware overview 52

Operation

4 Operation

Overview 73

Safety information 74

Workf low 75

Setup and operation 76

Removing used consumables 77

Continuous operation 79

Stopping the instrument during a run 81

Maintenance

5 Service

Overview 87

Safety information 88

BOD and EOD procedures 90

General cleaning 91

Regular maintenance 93

Preventive service 104

Troubleshooting

6 Troubleshooting

Overview 123

Error messages 124

Glossary

7 Glossary

Index

Index 139

Revisions

Roche Diagnostics

6 Instrument Manual · Version 3.0

COBAS® AmpliPrep Instrument

Roche Diagnostics

Instrument Manual · Version 3.0 7

COBAS® AmpliPrep Instrument

Intended use

The COBAS

®

AmpliPrep Instrument automates preparation of samples for

quantitative or qualitative nucleic acid testing. The COBAS

®

AmpliPrep Instrument is

to be used by laboratory professionals trained in laboratory techniques and by

instruction on the use of the instrument.

This manual can be used in conjunction with the Operator’s and Instrument Manuals

for the and the Application Manual for the AMPLILINK Software, Version 3.4 Series.

NOTICE

Notice

r This manual is only to be used for COBAS

®

AmpliPrep Instrument 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 and abbreviations

Product names Except where the context clearly indicated otherwise, the following product names

and descriptors are used.

Symbols used in the publication

Symbols used on the product

Product name Descriptor

COBAS

®

AmpliPrep Instrument

instrument

Table 3 Product names

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 4 Symbols used in the publication

Symbol Explanation

Global Trade Item Number

Quantity contained in the package.

Table 5 Symbols used on the product

COBAS® AmpliPrep Instrument

Roche Diagnostics

8 Instrument Manual · Version 3.0

Abbreviations The following abbreviations are used.

Abbreviation Definition

ANSI American National Standards Institute

EC European Community

EN European standard

IEC International Electrical Commission

IVD In vitro diagnostic

N/A not applicable

REACH Registration, Evaluation, Authorization, and Restriction of

Chemicals

UL Underwriters Laboratories Inc.

WEEE Waste Electrical and Electronic Equipment

Table 6 Abbreviations

Roche Diagnostics

Instrument Manual · Version 3.0 9

COBAS® AmpliPrep Instrument

What is new in Instrument Manual version 3.0

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

closing the main cover, the instrument 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, a cover on the syringe unit, and access

protection flaps for SPU loading, reagent loading as well as for the output tube

platform.

Lead A REACH statement about lead was added.

u Lead (p. 4)

Sharps, 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. 20)

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 Analyze r

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.

cobas p 630 instrument All information related to the cobas p 630 instrument has been removed from this

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

cobas p 630 instrument.

UV lights The UV lights have been removed from the instrument.

Compatibility o This publication is only to be used for COBAS

®

AmpliPrep Instrument with serial

number ≥ 450001.

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

Version 3.4.2.

COBAS® AmpliPrep Instrument

Roche Diagnostics

10 Instrument Manual · Version 3.0

What is new in Instrument Manual version 2.1

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

Diagnostics standards.

o The following sections were added:

u Where to find information (p. 2)

u License information (p. 3)

u Open-source and commerc ial software (p. 3)

u Fluorinated greenhou se gas (p. 4)

u Product names (p. 7)

u Abbreviations (p. 8)

o The approvals were updated and expanded:

u Approvals (p. 3)

o The content symbol was added:

u Symbols used on the product (p. 7)

Injuries due to unexpected

movement of parts

o The new safety label was added to list of safety labels:

u Safety labels on the system (p. 25)

o A new caution message was added to the general safety information and to all

service procedures performed with an open main cover:

u Mechanical safety (p. 22)

u Safety information (p. 88)

u Daily maintenance (p. 93)

u Changing environment fan filters (p. 104)

u Replacing gripper O-rings (p. 108)

u Checking the air system (p. 109)

u Replacing reagent tips (p. 111)

u Replacing syringe assembly (p. 113)

u Replacing UV lamps

u Shutting down the instrument for storage (p. 117)

Laser transmitter warnings The safety labels for the laser transmitter warnings were replaced. The location of the

safety label for the class 1 laser transmitter was updated:

u Safety labels on the system (p. 25)

Power requirements The line voltage and the line frequency were updated:

u Power requirements (p. 32)

Shutting down the instrument for

storage

A tip was added to contact Roche Service to perform this task.

u Shutting down the instrument for storage (p. 117)

Roche Diagnostics

Instrument Manual · Version 3.0 11

COBAS® AmpliPrep Instrument

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.

Checking the air system New service action for checking the air system added.

u For details, see Checking the air system (p. 109)

Error messages Error messages updated.

u For details, see Error messages (p. 124)

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 operating modes (“Probe mode” and “Generic mode”)

removed. There is only one operating mode available.

o Any reference to “magnetic particles” removed. Only magnetic glass particles are

in use.

o Any reference to the COBAS

®

AMPLICOR

®

analyzer removed.

o Information about the Windows operating system adapted.

COBAS® AmpliPrep Instrument

Roche Diagnostics

12 Instrument Manual · Version 3.0

System description

1 General safety information .............................................................................................................. 15

2 Overview .......................................................................................................................................... 29

3 Instrument........................................................................................................................................ 39

Roche Diagnostics

Instrument Manual · Version 3.0 15

COBAS® AmpliPrep Instrument 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

®

AmpliPrep Instrument.

In this chapter

Chapter

1

Safety classifications.............................................................................................................17

Safety precautions.................................................................................................................18

Operator qualification...................................................................................................18

Safe and proper use of the instrument ........................................................................18

Miscellaneous safety precautions.................................................................................19

Safety summary ....................................................................................................................20

Warning messages..........................................................................................................20

Sharps, rough edges, and/or moving parts...........................................................20

Electrical safety.........................................................................................................20

Biohazardous materials...........................................................................................21

Waste..........................................................................................................................21

Explosion and fire risk ............................................................................................22

Caution messages...........................................................................................................22

Mechanical safety.....................................................................................................22

Reagents and other working solutions..................................................................23

Insoluble contaminants in samples........................................................................23

Evaporation of samples or reagents .......................................................................23

Cross contamination ...............................................................................................24

Notices .............................................................................................................................24

Moving parts.............................................................................................................24

Circuit breakers and fuses.......................................................................................24

Spillage and liquid overflow ...................................................................................24

Safety labels on the system..................................................................................................25

Safety information for laser transmitters ..........................................................................27

Disposal of the instrument..................................................................................................28

Roche Diagnostics

16 Instrument Manual · Version 3.0

1 General safety information COBAS® AmpliPrep Instrument

Table of co nte nts

Roche Diagnostics

Instrument Manual · Version 3.0 17

COBAS® AmpliPrep Instrument 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. 25)

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

symbol:

q

Tip

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

Roche Diagnostics

18 Instrument Manual · Version 3.0

1 General safety information COBAS® AmpliPrep Instrument

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 instrument.

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 instrument

Personal protective equipment o 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 measuring result may lead to an error in diagnosis, therefore posing

danger to the patient.

o For proper use of the instrument, measure controls and monitor the instrument

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 instrument and reagent performance meet the

published specifications.

u Some tests have specific result interpretation criteria. For more detailed information,

refer to the Instructions for Use.

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

®

AmpliPrep Instrument only for preparing liquid samples with the

provided reagents as defined in the test specific Instructions for Use.

Roche Diagnostics

Instrument Manual · Version 3.0 19

COBAS® AmpliPrep Instrument 1 General safety information

Safety precautions

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

malfunction of the instrument (see Technical specifications (p. 32)).

o Use the instrument indoors only and avoid heat and humidity (see Technica l

specifications (p. 32)).

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

times.

o Perform maintenance according to the specified intervals to maintain the

operating conditions of the instrument.

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 instrument

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 instrument 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.

Instrument unused for an

extended period of time

If the instrument will not be used for more than 14 days, it is recommended that the

instrument be primed with deionized water and then with air before turning it off.

u For additional details, see Priming the instrument (p. 100) and Shutting down the

instrument for storage (p. 117)

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

transportation to personnel trained or authorized by Roche.

u For additional details, see Disposal of the instrument (p. 28)

Roche Diagnostics

20 Instrument Manual · Version 3.0

1 General safety information COBAS® AmpliPrep Instrument

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 (p. 71) and Chapter Service (p. 85).

Warning messages

WARNING

List of warning messages

r Before operating the instrument, 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 instrument other than those specified in this

Instrument Manual.

r Do not touch any parts of the instrument 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. 25).

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Roche COBAS AMPLIPREP User manual

Roche COBAS AMPLIPREP User manual

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