Roche cobas x 480 User manual

cobas

®

4800 System

System Manual

Software Version 2.1

cobas® 4800 System

System Manual

Roche Diagnostics

2 System Manual · Version 1.0

Document information

Revision history

Edition notice

This manual is for users 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 cobas® x 480 instrument or cobas® z 480 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 system is intended to be used as a diagnostic or screening system providing

sample preparation, amplification and detection of specific targets from human

samples.

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

Manual thoroughly before using the system.

The system is to be used by laboratory professionals trained in laboratory techniques

and by instruction on the use of 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 instrument and the analyzer meet the protection requirements laid down in IVD

Directive 98/79/EC.

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

international standards:

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:

Manual version Software version Revision date Changes

1.0 2.1 April 2013

Table 1 Revision history

Roche Diagnostics

System Manual · Version 1.0 3

cobas® 4800 System

System Manual

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.

1080 U.S. Highway South

Branchburg, NJ 08876-1760

USA

Made in Switzerland

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

cobas® 4800 System

System Manual

Roche Diagnostics

4 System Manual · Version 1.0

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System Manual · Version 1.0 5

cobas® 4800 System

System Manual

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 25

Disposal 27

2 Overview

System overview 31

3 Hardware

Instrument 39

Analyzer 65

Control unit 69

4 Software

Basic software elements 73

Database 81

Configuration

5 Configuration

Configuration 87

User management 92

Exporting support data 97

Result counters 98

Maintenance

6 Maintenance

Safety information 103

Instrument maintenance 104

Analyzer maintenance 115

Troubleshooting

7 Troubleshooting

Overview 129

Messages work area 131

About result flags 134

General troubleshooting 136

Hardware troubleshooting 138

Glossary

8 Glossary

Index

Index 149

Revisions

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cobas® 4800 System

System Manual

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cobas® 4800 System

System Manual

Preface

The system integrates fully automated total nucleic acid isolation directly from

primary and secondary tubes, automated PCR setup, and real time PCR.

This manual covers the complete system comprised of the cobas® 4800 software, the

instrument used for sample preparation, and the analyzer used for amplification and

detection using real time PCR.

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 For each test, there is a package insert which provides additional information. For

example, instructions on storage and handling of reagents, samples and controls.

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

System Manual

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8 System Manual · Version 1.0

Abbreviations The following abbreviations are used:

Product names The following product names are used:

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

cLLD Capacitive Liquid Level Detection

CSA Canadian Standards Association

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

approximates the audible range of the human ear.

DIL Diluent

DWP Deepwell Plate

EC European community

e.g. exempli gratia – for example

EMC ElectroMagnetic Compatibility

EN European standard

i.e. id est – that is to say

IEC International Electrical Commission

iSWAP internal Swivel Arm Plate handler

IVD In Vitro Diagnostic

KVA kilovolt-Ampere

LED Light Emitting Diode

LIS Laboratory information system

MWP Microwell plate

n/a not applicable

PCR Polymerase Chain Reaction

QC Quality Control

SD Standard deviation

UL Underwriters Laboratories Inc.

UPS Uninterruptible Power Supply

WEEE Waste Electrical and Electronic Equipment

XML Extensible Markup Language

Table 3 Abbreviations

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System Manual · Version 1.0 9

cobas® 4800 System

System Manual

Product name Abbreviation

cobas® 4800 software software

cobas x 480 instrument instrument

cobas z 480 analyzer analyzer

cobas

®

4800 System

system

Table 4 Product names

cobas® 4800 System

System Manual

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10 System Manual · Version 1.0

System description

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

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

3 Hardware.......................................................................................................................................... 37

4 Software............................................................................................................................................ 71

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cobas® 4800 System 1 General safety information

Table of contents System Manual

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

Optical safety............................................................................................................18

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

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

Explosion and fire risk ............................................................................................20

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

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

Reagents and consumables .....................................................................................21

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

Evaporation of samples or reagents.......................................................................21

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

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

Carryover ..................................................................................................................22

Hot surfaces ..............................................................................................................22

Malfunction due to interfering electromagnetic fields .......................................22

Data security.............................................................................................................23

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

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

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

Spillage.......................................................................................................................24

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

Safety labels on the instrument ....................................................................................25

Safety labels on the analyzer .........................................................................................26

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1 General safety information cobas® 4800 System

Table of contents System Manual

Disposal .................................................................................................................................27

Disposal of the instrument ...........................................................................................27

Disposal of the analyzer ................................................................................................27

Disposal of control unit components ..........................................................................27

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System Manual · Version 1.0 15

cobas® 4800 System 1 General safety information

System Manual 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. 25)

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.

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1 General safety information cobas® 4800 System

Safety precautions System Manual

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 personnel.

o Follow standard laboratory practices, especially when working with biohazardous

material.

Safe and proper use of the system

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

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 reagent performance meets the published

specifications.

Installation o Unpacking and installation must be performed by trained Roche Service

personnel only.

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

Operator’s Manuals to trained Roche Service personnel.

Correct use o Use the instrument only for preparing liquid samples with the provided reagents.

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

instrument or analyzer.

o Use the instrument and analyzer as indicated in the technical specifications.

o Make sure that the instrument’s and analyzer’s ventilation openings remain

unobstructed at all times.

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cobas® 4800 System 1 General safety information

System Manual Safety precautions

o Perform maintenance according to the specified intervals to maintain the

operating conditions of the instrument and analyzer.

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 instrument or

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.

Electromagnetic fields Devices that emit electromagnetic waves may cause the instrument or analyzer to

malfunction. Do not operate the following devices in the same room where the

instrument or analyzer are installed:

o Mobile phone

o Transceiver

o Cordless phone

o Other electrical devices that generate electromagnetic fields

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.

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

and transportation to personnel trained or authorized by Roche.

U For additional details, see Disposal (p. 27)

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18 System Manual · Version 1.0

1 General safety information cobas® 4800 System

Safety summary System Manual

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 Maintenance (p. 101) 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 instrument or analyzer other than those specified in

this manual or the test-specific Operator’s Manual.

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

Optical safety

WARNING

Loss of sight due to staring into laser beam

The barcode reader on the autoloader of the instrument contains a class II laser diode.

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

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cobas® 4800 System 1 General safety information

System Manual 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 Keep the main cover closed and in place while the instrument is operating.

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

r When working with the main cover open while the instrument is powered on (e.g., for

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

Shutdown status first.

r 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.

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.

WARNING

Infection and injury due to sharp objects

When wiping sharp objects, use several layers of gauze.

r Be careful to not puncture yourself.

r Be sure to wear appropriate protective equipment, for example gloves.

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 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 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. 25)

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. 27)

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1 General safety information cobas® 4800 System

Safety summary System Manual

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

instrument or 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 Keep the cover closed while the instrument and analyzer is connected to the main

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

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 pipetting head of the instrument moves rapidly during sample preparation. The main

cover is locked during operation, protecting the user from moving parts.

r Keep the main cover closed and in place while the instrument is operating.

r When working with the main cover open while the instrument is powered on (e.g., for

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

Shutdown status first.

r Do not touch any parts of the instrument or analyzer other than those specified. Keep

away from moving parts during instrument operation.

r Do not remove any carrier from the instrument deck while the instrument is operating.

r Keep the main cover closed and in place while the instrument is operating.

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

instructions.

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

(p. 25)

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