Roche cobas x 480 User manual

1

cobas

®

4800 System

User Assistance version 2.0

Software version 2.2

Roche Diagnostics

cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0

2

Publication information

Edition notice This publication is intended for operators of the

cobas x 480 instrument and/or the cobas z 480

analyzer.

Every effort has been made to ensure that all the

information contained in this publication is correct at the

time of publishing. However, the manufacturer of this

product 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 User Assistance contains all information about the

product, including the following:

• Routine operation

• Maintenance

• Safety

• Troubleshooting information

• A software reference

• Configuration information

• Background information

The Safety chapter contains important safety

information. You must read the Safety chapter before

operating the system.

Publication

version

System software

version

Revision date Change description

1.0 2.2 May 2015 First version. New manual structure and design. Software

update from 2.1 to 2.2

2.0 2.2 April 2017 o Added RoHS directive 2011/65/EU to Approvals section.

o Compliance marks updated to include ‘CSA’ and

‘Laboratory Equipment’.

o Symbols used on product updated to include ‘Cont.’,

‘Content’ and ‘A/C only’.

o Transferred general safety messages to Safety chapter and

revised safety messages throughout manual.

o In chapter Introduction to the user interface, added About

the sample editor section and About the results work area

section.

o Revised cleaning procedure of the instrument.

o Updated images of thermal cycler door (analyzer) in

Exchanging fuses section.

o Added new Operation chapter with available workflows.

o Added information on new integrated heater/shaker unit.

o Revised description for sealing the microwell plate.

o Changed name of deliverable from cobas

®

4800 System

System Manual to cobas

®

4800 System User Assistance.

o Added new Safety chapter. Information of previous Safety

manual is now integrated in this manual as Safety chapter.

y Revision history

Roche Diagnostics

cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0

3

The test-specific Instructions for Use provides

additional information such as instructions on storage

and handling of reagents, samples, and controls. The

Instructions for Use also provides information on manual

PCR setup of the microwell plate.

Before using the system, it is important that the operator

reads these publications.

!

General attention

To avoid serious or fatal injury, ensure that you are

familiar with the instructions and safety information

before you use the instrument or analyzer.

r Pay particular attention to all safety precautions.

r Always follow the instructions in this publication.

r Do not use the instrument or analyzer in a way that is

not described in this publication.

r Store all publications in a safe and easily retrievable

place.

Privacy notice

When you use User Assistance on line, viewing events

(topics viewed and searches performed) and IP addresses

are logged.

The data collected is for Roche internal use only and is

never forwarded to third parties. It is anonymized, and

after one year it is automatically deleted.

Viewing events are analyzed to improve User Assistance

content and search functionality. IP addresses are used to

classify regional behavior.

You can configure how data is collected.

u Configuring User Assistance data collection (26)

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.

Roche Diagnostics

cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0

4

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.

reserved.

License information

cobas

®

4800 software is protected by contract law,

copyright law, and international treaties. cobas

®

4800

software 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.

Trademarks The following trademarks are acknowledged:

COBAS, COBAS X, 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 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 instrument and the analyzer meet the protection

requirements laid down in:

Directive 98/79/EC of the European Parliament and of the

Council of 27 October 1998 on in vitro 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.

The analyzer is manufactured and tested according to the

following international standards:

• IEC 61010-1

• IEC 61010-2-101

• UL 61010-1

• CAN/CSA C22.2 No. 61010-1

Compliance with the applicable directive(s) is provided by

means of the Declaration of Conformity.

Roche Diagnostics

cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0

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The following marks demonstrate compliance:

Contact addresses

Complies with the IVD directive 98/79/EC on in vitro

diagnostic medical devices.

For in vitro diagnostic use.

Issued by Underwriters Laboratories, Inc. (UL) for

Canada and the US.

Issued by CSA Group for Canada and the US.

'Laboratory Equipment' is the product identifier as

shown on the name plate.

CUS

cobas z 480 analyzer and cobas

®

4800 software

Roche Molecular Systems Inc.

1080 US Highway 202 South

Branchburg, NJ 08876

USA

Made in Switzerland

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

cobas x 480 instrument

HAMILTON Bonaduz AG

Via Crusch 8

CH-7402 Bonaduz

Switzerland

Made in Switzerland

Roche Diagnostics

cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0

6

Distributed in the United States by:

Roche Diagnostics

9115 Hague Road

Indianapolis

Indiana

USA

Roche Diagnostics

cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0

7

Roche Diagnostics

cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0

8

Table of contents 9

Roche Diagnostics

cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0

Table of contents

Publication information 2

Contact addresses 5

Table of contents 9

Preface 11

Intended use 12

Symbols and abbreviations 12

What is new in publication version 2.0 15

What is new in publication version 1.0 16

User Assistance

1 User Assistance

Using User Assistance 23

Safety

2 General safety information

Introduction 31

Safety classifications 32

Safety precautions 33

Warning messages 36

Caution messages 50

Notices 53

Safety labels on the system 55

Safety information for disposal 61

System description

3 Overview

System overview 67

4 Hardware

Instrument overview 77

Analyzer overview 98

Consumables overview 103

Control unit overview 108

About the hand-held barcode reader 109

Barcode configuration specifications 110

5 Introduction to the user interface

About the screen design 113

About the sample editor 123

About the results work area 130

About the database 145

About the audit trail 147

Operation

6 Operation

About workflows 153

Full workflow overview 155

Recovery workflow overview 190

PCR Only workflow overview 202

Configuration

7 Configuration

About configuration 225

About managing users 230

Exporting support data 238

About result counters 239

Maintenance

8 Maintenance

Instrument maintenance 245

Analyzer maintenance 276

Troubleshooting

9 Troubleshooting

Troubleshooting information in the user

interface 293

About the messages work area 295

Reviewing and confirming new alarms 297

Deleting alarms and messages 298

Troubleshooting software 299

Troubleshooting hardware 302

List of error messages and system flags

10 Error messages and system flags

Error messages 315

List of error messages 316

System flags 350

List of system flags 351

Glossary

11 Glossary

Index

Index 363

10 Table of contents

Roche Diagnostics

cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0

Roche Diagnostics

cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0

11

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:

• cobas

®

4800 software

• cobas x 480 instrument used for sample preparation

• cobas z 480 analyzer used for amplification and

detection using real time PCR

Roche Diagnostics

cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0

12

Intended use

System

(instrument and analyzer)

The cobas

®

4800 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 integrates fully automated

total nucleic acid isolation directly from primary and

secondary tubes, automated PCR setup, and real time

PCR.

Analyzer The cobas z 480 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 cobas x 480 instrument and cobas z 480 analyzer

are to be used by laboratory professionals trained in

laboratory techniques and by instruction on the use of the

system and analyzer.

Symbols and abbreviations

Product names Except where the context clearly indicates otherwise, the

following product names and abbreviations are used:

Product name Descriptor

cobas

®

4800 software

software

cobas x 480 instrument instrument

cobas z 480 analyzer analyzer

cobas

®

4800 System

system

cobas

®

4800 System Sample

Preparation Kit

sample preparation kit

Extraction plate 1.6ml deepwell plate

Extraction plate 2.0ml deepwell plate

AD-plate 0.3ml microwell plate

Reagent reservoir 50ml 50 mL reagent reservoir

Reagent reservoir 200ml 200 mL reagent reservoir

Core Tips with Filter 1ml pipette tip

PreservCyt

®

carrier

collection medium carrier

(test-specific)

y Product names

Roche Diagnostics

cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0

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Symbols used in the publication

Symbols used on product

Symbol Explanation

o List item

u Related topics containing further information.

q Tip. Extra information on correct use or useful

hints.

r Start of a task

I Extra information within a task

f Result of a user action within a task

c Frequency of a task

n Duration of a task

d Materials that are required for a task

j Prerequisites of a task

u Topic. Used in cross-references to topics.

p Task. Used in cross-references to tasks.

w Figure. Used in figure titles and cross-

references to figures.

y Table. Used in table titles and cross-references

to tables.

z Equation. Used in cross-references to

equations.

k Code example. Used in code titles and cross-

references to codes.

Print. Used for printable documents.

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.

y Symbols used in the publication

Symbol Explanation

Global Trade Item Number.

y Symbols used on product

Roche Diagnostics

cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0

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Abbreviations The following abbreviations are used:

Quantity contained in the package.

Indicates that the equipment is suitable for

alternating current only; to identify relevant

terminals.

Symbol Explanation

y Symbols used on product

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.

DWP Deepwell plate

EC European Community

e.g. Exempli gratia – for example

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

LED Light emitting diode

LIS Laboratory information system

MWP Microwell plate

n/a Not applicable

PCR Polymerase chain reaction

UL Underwriters Laboratories Inc.

UPS Uninterruptible power supply

WEEE Waste Electrical and Electronic Equipment

XML Extensible Markup Language

y Abbreviations

Roche Diagnostics

cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0

15

What is new in publication version 2.0

Short description of all major changes in this version.

User Assistance chapter Added new chapter on using the User Assistance.

u Using User Assistance (23)

Safety information chapter Added new general safety information chapter.

u Safety classifications (32)

Integrated heater/shaker unit Added information on new integrated heater/shaker unit

in the instrument.

u Heater/shaker unit (94)

Sample editor section Added section on sample editor for handling work order

files.

u About the sample editor (123)

Results work area section Added section on the results work area.

u About the results work area (130)

New Operation chapter Added new Operation chapter with possible workflows

for performing a run.

u About workflows (153)

Cleaning procedure The cleaning solution for the instrument has been revised.

u About cleaning the instrument (247)

New decontamination section Added new section on instrument decontamination.

u Decontamination (264)

Thermal cycler door The thermal cycler door of the analyzer has been

modified. The door is now fitted with a metal hinge

covering the secondary fuses. To replace a secondary

fuse, you must now open the thermal cycler door.

u To exchange a secondary fuse (285)

Error messages and flags chapter Added new chapter on error messages and system flags.

u Error messages (315)

u System flags (350)

Roche Diagnostics

cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0

16

What is new in publication version 1.0

Short description of all major changes in publication

version 1.0.

Solid waste door New hardware. The solid waste door allows you to access

and replace the small solid waste bag or waste chute

easily.

u About the waste station setup (84)

Enhancement to pipette tip pickup To minimize generating multiple partial tip racks after a

run, the system uses pipette tips from partial tip racks

before pipette tips from full tip racks.

u About the pipette tips (104)

Supported character formats for barcodes / is a supported barcode character.

u Barcode configuration specifications (110)

Sorting results function Results can be sorted by quantity.

u About sorting by column (117)

Result filter by sample Filtering options for controls. You can now filter results

based on sample types.

u Creating result filters (141)

Sorting of reports The laboratory manager can configure how the results

are sorted in the PDF results report.

u Reporting overview (226)

Button name The Extract support data button is renamed to Export

support data button.

u Exporting support data (238)

Weekly maintenance Additional alignment check during weekly maintenance

to ensure that instrument is within alignment

(approximately 7 extra minutes for weekly maintenance).

u Weekly maintenance (259)

Roche Diagnostics

cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0

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Roche Diagnostics

cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0

18

Roche Diagnostics

cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0

User Assistance

1 User Assistance ...................................................................................................... 21

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