Roche Cobas 4800 System Guide de l'utilisateur

cobas®

4800

System

Manual

Software

Version

2.1

cobas®

4800 System

Document

information

Systeni

Manual

Revision

history

Instrument

approvals

Roche

Diagnostics

Manual

version Software version

Revision

date

Changes

1.0

2.1

April2013

Table

Revsion

history

Edition

notice

This

manual

for

users of the

cobas

4800

System.

Every

effort

has

been

made

ensure

that

all

the

information contained

this

manual

correct

the

time of

printing.

However,

Roche

reserves

the

right

make

any

changes

necessary

without

notice

part

ongoing

product

development.

Any

customer modification

the

cobas

480

instrument

cobas

480

analyzer

will

render

the

warranty

service

agreement

null

and

void.

Software

updates

are

done

Roche

Service

representatives.

The

screenshots

this

publication

have

been

added

exclusively for

the

purpose

ilustration.

Configurable

and

variable

data

such

parameters,

resuits,

path

names

etc.

visible

therein

must

not

used

for

laboratory purposes.

Intended

use

The

system

intended

used

diagnostic

screening

system

providing

samplepreparation,

amplification and

detection

specific

targets from

human

samples.

important

that

the

operator

reads

this

manual and

the

test-specific

Operator’s

Manual

thoroughly

before

using

the

system.

The

system

used

laboratory

professionals

trained

laboratory

techniques

and

instruction

the

use

of the

system.

2013,

Roche

Diagnostics

International

Ltd. All

rights reserved.

Tradernarks

The

following

trademarks

are

acknowledged:

COBAS, COBAS

and

LIFE

NEEDS

ANSWERS are

trademarks

Roche.

All

other

trademarks

are

the

property

their

respective

owners.

Feedback

Every

effort

has

been

made

ensure

that

this

manual

fulfills

the

intended purpose

mentioned

above.

All

feedback

any

aspect

this

manual

welcome

and

will

considered

during

updates.

Please

contact

your

Roche

representative,

should

you

have

any such

feedback.

The

instrument

and

the analyzer

meet

the

protection

requirements

laid

down

IVD

Directive

98/79/EG.

Furthermore,

the analyzer

manufactured

and

tested

according

the

following

international

standards:

•

lEG 61010-1

•

lEG

61010-2-101

•

UL61O1O-1

•

CAN/CSA

C22.2

No.

61010-1

This

manual

meets

the

European Standard

EN ISO

18113-3.

Compliance

demonstrated

the

following marks:

System

Manual

Version

1.0

cobas®

4800 System

Systeni

Manual

Contact

addresses

Roche

Diagnostics

System

Manual

Version

1.0

(

Complies

with

the

IVD

directive 98/79/EG.

Issued

underwriters

laboratories,

mc.

(UL)

for

Canada

and the

US.

C®(JS

Roche

Molecular

Systems,

mc.

1080

U.S.

Highway South

Branchburg,

08876-

1760

USA

Made

Switzerland

Roche

Diagnostics

GmbH

ECIREPI

SandhoferStrasse

116

68305

Mannheim

Germany

cobas®

4800

System

Manual

Roche

Diagnostics

System

Manual

Version

1.0

cobas®

4800

System

Sys(em

Iftinunl

Table

contents

Document

information

Contact

addresses

Table

contents

Preface

How

to use this

manual

Where

find

information

Conventions

used

this

manual

Software

Basic

software

elements

Database

Configuration

User

management

Exporting

support

data

Result

counters

Maintenance

Safety

information

Instrument

maintenance

Analvzer

maintenance

Roche

Diagnostics

System

Manual

Version

1.0

103

104

115

Troubleshooting

System

description

Troubleshooting

Overview

129

Messages

work

area

131

About

result

flags

134

General

troubleshooting

136

Hardware

troubleshooting

138

Glossary

Index

149

Revisions

General

safety

information

Safety

classifications

Safety

precautions

Safety

summary

Safety

labels on

the

system

Disposal

Overview

System

overview

Hardware

Instrument

Analyzer

Control

unit

cobas®

4800

System

I’4anual

Roche Diagnostics

System

Manual

Version

1.0

cobas®

4800

System

Systeni

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

use

this

manual

•

Keep

this

manual

safe

place

ensure

that

not

damaged

and

remains

available

for

use.

•

This

manual

should

be easily

accessible

all

times.

help

you

find

information

quickly,

there

is a

table of

contents

the

beginning

the

manual

and

each

chapter.

addition,

complete index

can

found

the

end

the

manual.

Where to

find

information

addition

this

manual,

the

following

documents

are

also

provided

assist

finding

desired

information

quickly:

Test-specfic

Operator

Manuals

For

each

test,

there

is a

specific Operator’s

Manual

which describes how

prepare

and

perform

run,

and

how

handle

results.

Test

-spec

ficpackage

insert

For

each

test,

there

package

insert

which

provides

additional

information.

For

example,

instructions

storage

and handling

of reagents,

samples

and

controls.

Conventions

used

this

manual

Visual cues are

used

help

locate

and

interpret information

this

manual

quickly.

This

section

explains

formatting

conventions

used

this

manual.

Symbols

The

following symbols

are

used:

Symbol

Used

for

(

Start

procedure

End

procedure

List

item

(j)

Cross-reference

C’

Cail-up (software reference)

Table

Symbols

used

Roche

Diagnostics

System

Manual

Version

1.0

cobas®

4800

System

Systern

Manual

Symbol

Used

for

Tip

j/’

Safety

alert

‘.‘

Electrical and

electronic

equipment

marked

with

this

symbol

are

/Y\

covered

the

European

Directive

2002/961EC

waste

electrical

and

electronic

equipment

(WEEE).

The

symbol

denotes

that

the

equipment

must not

disposed of

the municipal

waste

system.

Table

Symbols

used

Abbreviations

The

following

abbreviations

are

used:

Abbreviation

Definition

Amplification

and detection

ANSI

American National

Standards

Institute

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

the

human

ear.

DIL

Diluent

DWP

Deepweil Plate

European

community

e.g.

exempli

gratia

—

for

example

EMC

ElectroMagnetic

Compatibility

European

standard

ie.

est

—

that

say

IEC

International

Electrical

Commission

iSWAP

internal

Swivel

Arm

Plate

handler

IVD

Vitro

Diagnostic

KVA

kilovolt-Ampere

LED

Light

Emitting

Diode

LIS

Laboratory

information

system

MWP

Microweli

plate

n/a

not

applicable

PCR

Polymerase

Chain Reaction

Quality

Control

Standard deviation

Underwriters

Laboratories

mc.

UPS

Uninterruptible

Power Supply

WEEE

Waste

Electrical

and

Electronic

Equipment

XML

Extensible

Markup

Language

Table

Abbreviations

Roche

Diagnostics

Product

narnes

The

following

product

names

are

used:

System

Manual

Version

1.0

cobas®

4800 System

Systern

Manual

Roche

Diagnostics

System

Manual

Version

1.0

Product

name

Abbreviation

cobas

4800

software

cobas

480

instrument instrument

cobas

480

analyzer

cobas

4800

System

system

Tahie

Product

nam

cobas®

4800 System

Systeni

Manual

Roche

Diagnosti

System

Manual

Version

1.0

Table des matières

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