Roche cobas z 480 User manual

cobas

®

4800 System

cobas z 480 analyzer

Instrument Manual

Software Version 2.1

cobas® 4800 System

cobas z 480 analyzer

Roche Diagnostics

2 Instrument Manual · Version 1.2

Document information

Revision history

Edition notice

This manual is for users of the cobas z 480 analyzer which is part of the cobas

®

4800

System.

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

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

The screenshots in this publication have been added exclusively for the purpose of

illustration. Configurable and variable data such as parameters, results, path names

etc. visible therein must not be used for laboratory purposes.

Intended use The analyzer including dedicated software for IVD use is a plate-based automated

amplification and detection system for nucleic acids. The analyzer is intended to be

used as an in-vitro diagnostic or screening system providing real time PCR

amplification and detection for human samples within the system. The analyzer is to

be used by laboratory professionals trained in laboratory techniques and by

instruction on the use of the analyzer.

The system including dedicated software for IVD use is intended to be used as an in-

vitro diagnostic or screening system providing amplification and detection of specific

targets from human samples. The system is to be used by laboratory professionals

trained in laboratory techniques and by instruction on the use of the system.

It is important that the operator reads this manual and the test-specific Operator’s

Manual thoroughly before using the system.

Trademarks The following trademarks are acknowledged:

COBAS, COBAS Z, and LIFE NEEDS ANSWERS are trademarks of Roche.

All other trademarks are the property of their respective owners.

Feedback Every effort has been made to ensure that this manual fulfills the intended purpose as

mentioned above. All feedback on any aspect of this manual is welcome and will be

considered during updates. Please contact your Roche representative, should you

have any such feedback.

Instrument approvals The analyzer meets the protection requirements laid down in IVD Directive

98/79/EC.

Furthermore, the analyzer is manufactured and tested according to the following

international standards:

Manual version Software version Revision date Changes

1.1 2.1 May 2013 Updated to 2.1

1.2 2.1 February 2015 Minor update to the

description of the

consumables.

Table 1 Revision history

Roche Diagnostics

Instrument Manual · Version 1.2 3

cobas® 4800 System

cobas z 480 analyzer

o IEC 61010-1

o IEC 61010-2-101

o UL 61010-1

o CAN/CSA C22.2 No. 61010-1

This manual meets the European Standard EN ISO 18113-3.

Compliance is demonstrated by the following marks:

Contact addresses

Complies with the IVD directive 98/79/EC.

Issued by underwriters laboratories, Inc. (UL) for Canada and the US.

CUS

®

Roche Molecular Systems Inc.

Building 500

1080 U.S. Highway 202

Branchburg, NJ 08876

U.S.A.

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

cobas® 4800 System

cobas z 480 analyzer

Roche Diagnostics

4 Instrument Manual · Version 1.2

Roche Diagnostics

Instrument Manual · Version 1.2 5

cobas® 4800 System

cobas z 480 analyzer

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 7

Conventions used in this manual 7

System description

1 General safety information

Safety classifications 15

Safety precautions 16

Safety summary 18

Safety labels on the system 24

Disposal 25

2 Overview

System overview 29

3 Hardware

Analyzer 35

Control unit 39

4 Software

Basic software elements 45

Database 53

Operation

5 Operation

Safety information 59

Operation 60

Configuration

6 Configuration

Configuration 67

User management 72

Exporting support data 77

Result counters 78

Maintenance

7 Maintenance

Safety information 83

Analyzer maintenance 84

Troubleshooting

8 Troubleshooting

Overview 99

Messages work area 101

About result flags 104

General troubleshooting 106

Hardware troubleshooting 108

Glossary

9 Glossary

Index

Index 115

Revisions

Roche Diagnostics

6 Instrument Manual · Version 1.2

cobas® 4800 System

cobas z 480 analyzer

Roche Diagnostics

Instrument Manual · Version 1.2 7

cobas® 4800 System

cobas z 480 analyzer

Preface

This manual covers the analyzer that is used for amplification and detection using

real time PCR within the system.

How to use this manual

Q

o Keep this manual in a safe place to ensure that it is not damaged and remains available

for use.

o This manual should be easily accessible at all times.

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

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

of the manual.

Where to find information

In addition to this manual, the following documents are also provided to assist in

finding desired information quickly:

Test-specific Operator’s Manuals For each test, there is a specific Operator’s Manual which describes how to prepare

and perform a run, and how to handle results.

Test-specific package insert The test-specific package insert provides information on preparation and handling of

the reagent and DNA isolation kit as well as on manual PCR setup of the microwell

plate.

Conventions used in this manual

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:

Symbol Used for

P Start of procedure

S End of procedure

o List item

U Cross-reference

h Call-up (software reference)

Table 2 Symbols used

cobas® 4800 System

cobas z 480 analyzer

Roche Diagnostics

8 Instrument Manual · Version 1.2

Abbreviations The following abbreviations are used:

Product names Except where the context clearly indicates otherwise, this manual uses the following

descriptions:

Q Tip

Safety alert

Electrical and electronic equipment marked with this symbol are

covered by the European Directive 2002/96/EC on waste electrical

and electronic equipment (WEEE).

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

the municipal waste system.

Symbol Used for

Table 2 Symbols used

Abbreviation Definition

AD Amplification and detection

ANSI American National Standards Institute

cc cubic centimeter

CSA Canadian Standards Association

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

approximates the audible range of the human ear.

EC European community

e.g. exempli gratia – for example

EN European standard

i.e. id est – that is to say

IEC International Electrical Commission

IVD In vitro diagnostic

KVA kilovolt-Ampere

LED Light Emitting Diode

MWP Microwell plate

n/a not applicable

PCR Polymerase Chain Reaction

UL Underwriters Laboratories Inc.

Table 3 Abbreviations

Product name Abbreviation

cobas® 4800 software software

cobas z 480 analyzer

analyzer

cobas

®

4800 System

system

Table 4 Product names

Roche Diagnostics

Instrument Manual · Version 1.2 9

cobas® 4800 System

cobas z 480 analyzer

cobas® 4800 System

cobas z 480 analyzer

Roche Diagnostics

10 Instrument Manual · Version 1.2

System description

1 General safety information.............................................................................................................. 13

2 Overview .......................................................................................................................................... 27

3 Hardware.......................................................................................................................................... 33

4 Software............................................................................................................................................ 43

Roche Diagnostics

Instrument Manual · Version 1.2 13

cobas® 4800 System 1 General safety information

Table of contents cobas z 480 analyzer

General safety information 1

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

In this chapter

Chapter

1

Safety classifications.............................................................................................................15

Safety precautions.................................................................................................................16

Operator qualification...................................................................................................16

Safe and proper use of the system................................................................................16

Miscellaneous safety precautions.................................................................................17

Safety summary ....................................................................................................................18

Warning messages..........................................................................................................18

Electrical safety.........................................................................................................18

Biohazardous materials ...........................................................................................19

Waste..........................................................................................................................19

Explosion and fire risk ............................................................................................19

Reagents and consumables .....................................................................................20

Caution messages...........................................................................................................20

Mechanical safety.....................................................................................................20

Reagents and consumables .....................................................................................20

Carryover ..................................................................................................................21

Interfering substances in samples ..........................................................................21

Hot surfaces ..............................................................................................................21

Malfunction due to interfering electromagnetic fields .......................................21

Incorrect results due to two barcode labels or incorrect specimen labeling....22

Incorrect results due to wrongly typed sample IDs.............................................22

Data security.............................................................................................................22

Notices .............................................................................................................................23

Moving parts.............................................................................................................23

Circuit breakers and fuses.......................................................................................23

Spillage.......................................................................................................................23

Safety labels on the system ..................................................................................................24

Safety labels on the analyzer .........................................................................................24

Disposal .................................................................................................................................25

Disposal of the analyzer ................................................................................................25

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14 Instrument Manual · Version 1.2

1 General safety information cobas® 4800 System

Table of contents cobas z 480 analyzer

Disposal of control unit components ..........................................................................25

Roche Diagnostics

Instrument Manual · Version 1.2 15

cobas® 4800 System 1 General safety information

cobas z 480 analyzer Safety classifications

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 meanings and icons:

Safety information

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 product safety labels, see Safety labels on the system (p. 24)

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

symbol:

Q

Tip

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

Roche Diagnostics

16 Instrument Manual · Version 1.2

1 General safety information cobas® 4800 System

Safety precautions cobas z 480 analyzer

Safety precautions

Safety information

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 all relevant

manuals.

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

Roche Diagnostics.

o Carefully follow the procedures specified in all relevant manuals for operation

and maintenance.

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

trained Roche Service representative.

o Follow standard laboratory practices, especially when working with biohazardous

material.

Safe and proper use of the system

Personal protective equipment o Wear appropriate protective equipment, including, but not limited to, safety

glasses with side shields, fluid resistant laboratory coat, and approved disposable

gloves.

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

Accuracy/precision of measured

results

o Do not use reagents that have exceeded their expiry 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 Unpacking and installation must be performed by trained Roche Service

representative only.

o Leave installation that is not described in this manual or the test-specific

Operator’s Manuals to a trained Roche Service representative.

Operating conditions o Operation outside of the specified ranges, e.g. with excessive environmental

temperature and/or humidity, may lead to incorrect results or malfunction of the

analyzer.

o Use the analyzer as indicated in the technical specifications.

o Make sure that the ventilation openings remain unobstructed at all times.

Roche Diagnostics

Instrument Manual · Version 1.2 17

cobas® 4800 System 1 General safety information

cobas z 480 analyzer Safety precautions

o Perform maintenance according to the specified intervals to maintain the

operating conditions.

o Keep all manuals in a safe place to ensure that it is not damaged and remains

available for use. All manuals 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.

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

may result in incorrect behavior of the system or the software. Do not install any

non-approved software.

Miscellaneous safety precautions

Power interruption A power failure or momentary drop in voltage may lead to data loss. Operation with

an uninterruptible power supply (UPS) is strongly recommended. Check the UPS

regularly to make sure it functions properly.

If there is a power failure, the analyzer is disconnected from the control unit. The

displayed maintenance status of the analyzer may not be correct. To get the correct

maintenance status, refresh the analyzer under Overview > System > cobas z480 tab.

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

transportation to personnel trained or authorized by Roche.

U For additional details, see Disposal (p. 25)

Data backup There is an automatic backup process that stores the data on the D drive. It is the

customers responsibility to perform regular backups of all measurement results.

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18 Instrument Manual · Version 1.2

1 General safety information cobas® 4800 System

Safety summary cobas z 480 analyzer

Safety summary

This safety summary contains the most important and general warning and caution

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

Part Operation (p. 57) and Part Maintenance (p. 81) and in the test-specific

Operator’s Manuals.

U For more information about the safe use of the system, refer to the test-specific package

insert.

Warning messages

WARNING

List of warning messages

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

and in all relevant manuals carefully. Failure to observe them may result in death or

serious injury.

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 manual or

the test-specific Operator’s Manual.

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 mains 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. 24)

Roche Diagnostics

Instrument Manual · Version 1.2 19

cobas® 4800 System 1 General safety information

cobas z 480 analyzer Safety summary

Biohazardous materials

WARNING

Infection by samples and associated materials

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. Therefore, universal precautions should be taken when handling

and processing samples.

r Follow standard laboratory practices, especially when working with biohazardous

material.

r Do not open the thermal block cycler door during operation.

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

glasses with side shields, fluid resistant laboratory 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.

r If sample or liquid waste comes into contact with your skin, wash it off immediately

with soap and water, and apply a disinfectant. Consult a physician.

Waste

WARNING

Infection by biohazardous waste

Liquid and solid waste originates from samples collected in media that inactivate

potentially biohazardous material. However, as with all human-derived solutions, universal

precautions should be taken when handling waste.

Contact with liquid waste or used pipetting tips may result in infection. All materials and

mechanical components that come into contact with waste are potentially biohazardous.

Therefore, universal precautions should be taken when handling waste.

r 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 liquid waste comes into contact with your skin, wash it off immediately with soap and

water, and apply a disinfectant. Consult a physician immediately.

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

(p. 24)

WARNING

Contamination of the environment by liquid waste and solid waste

The waste generated during the procedure is potentially biohazardous.

r When disposing of any liquid or solid waste, do so according to the appropriate local

regulations.

U For information about disposal, see Disposal (p. 25)

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

20 Instrument Manual · Version 1.2

1 General safety information cobas® 4800 System

Safety summary cobas z 480 analyzer

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 During fire-fighting operations disconnect the equipment from the main power supply.

r Do not remove the analyzer’s cover while the analyzer is connected to the main power

supply, and do not use sprays in the vicinity of the analyzer.

Reagents and consumables

WARNING

Invalid results due to expired reagents and consumables

Data obtained using expired reagents and consumables are not reliable. Reagents are

supplied in a kit package with a label that indicates the expiry date. The expiry date of

microwell plate and sealing film is printed on their package label.

r Use only Roche consumables designed for use on the system.

r Do not reuse consumables. All consumables are designed for one time use only.

r Inspect consumables before use. Do not use damaged consumables.

r Do not use reagents and consumables that have exceeded their expiry dates. Replace

expired reagents and consumables with unexpired reagents and consumables before

sample processing.

Caution messages

CAUTION

List of caution messages

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

and in all relevant manuals carefully. Failure to observe them may result in minor or

moderate injury.

Mechanical safety

CAUTION

Personal injury due to contact with moving parts

The analyzer’s microwell plate loader moves during plate loading.

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

moving parts during operation.

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

(p. 24)

Reagents and consumables

CAUTION

Skin inflammation or injury caused by reagents

Direct contact with reagents, detergents, or cleaning solutions may cause skin irritation,

inflammation, or burns.

r When handling reagents, exercise the precautions required for handling laboratory

reagents. Be sure to wear protective equipment (such as goggles, gloves).

r Observe the cautions given in the package insert and observe the information given in

the Material Safety Data Sheets available for Roche Diagnostics reagents and cleaning

solutions.

r If a reagent or detergent comes into contact with your skin, wash it off immediately

with soap and water, and apply a disinfectant. Consult a physician immediately.

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Roche cobas z 480 User manual

Roche cobas z 480 User manual

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