Roche cobas s 201 system User manual

cobas s 201 System 0

Operator’s Manual Supplement

for Use of the Docking Station

P/N: 05216486190-01

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Preface

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Table of Contents

Preface

Table of Contents .......................................................................... 0.3

Revision History ............................................................................0.4

How to Use this Supplement ........................................................ 0.6

Conventions Used in This Supplement .......................................0.7

Glossary ........................................................................................ 0.10

Operational Precautions and Limitations .................................. 0.12

Warnings ...................................................................................... 0.13

Intended Use ................................................................................0.13

1. Workflow

Overview ........................................................................................ 1.1

Perform Startup Procedures ......................................................... 1.2

Load Reagents ................................................................................1.4

Load Consumables ........................................................................1.6

Create Orders ................................................................................. 1.8

Load SK24 Racks ...........................................................................1.9

Start the Run ................................................................................1.10

Remove Used Consumables ........................................................ 1.12

Review Run Messages .................................................................. 1.12

Accept Results .............................................................................. 1.12

2. Docking Station

Overview ........................................................................................ 2.1

Installation .....................................................................................2.2

Methodology .................................................................................. 2.3

Loading Empty K-carriers ............................................................. 2.5

Docking Station Maintenance ...................................................... 2.6

3. Index

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Revision History

The Docking Station is manufactured by:

Manual Revision Revision Date

1.0 May 2008

Manufacturer Roche Instrument Center AG

CH-6343 Rotkreuz

Switzerland

Distributed by

Roche Diagnostics

Indianapolis, IN 46256 USA

(For Technical Assistance call the

Roche Response Center

toll-free 1-800 526 1247)

Roche Diagnostics

H7V 4A2 Laval, Quebec

(For Technical Assistance call:

Pour toute assistance technique,

appeler le: 1-877 273 3433)

Roche Diagnostics (Schweiz) AG

CH-6343 Rotkreuz

Roche Diagnostics

F-38240 Meylan

Roche Diagnostics GmbH

D-68298 Mannheim, Germany

Distributore in Italia:

Roche Diagnostics SpA

Piazza Durante 11

I-20131 Milano

Roche Diagnostics S.L.

E-08006 Barcelona

Distribuidor em Portugal:

Roche Farmacêutica Química, Lda

P-2700 Amadora

Declaration of Conformity

The cobas s 201 system Docking Station complies with the requirements of

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

27 October 1998 on In-vitro Diagnostic Medical Devices.

Preface

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Questions or comments regarding the contents of this manual can be

directed to the address below or to your Roche representative.

Roche Molecular Systems, Inc.

4300 Hacienda Drive

Pleasanton, California 94588-2722

ROCHE, AMPERASE, AMPLILINK, COBAS, COBAS S, AMPLIPREP and

TAQMAN are trademarks of Roche.

ROCHE RESPONSE CENTER is a servicemark of Roche.

Microlab is a registered trademark of Hamilton Company.

Microsoft, Windows, and Windows XP are either registered trademarks or

trademarks of Microsoft Corporation in the United States and/or other

countries.

AMPLILINK Software:

The Source Code version of the executable code (the "Software") is

available under the terms of the Interbase Public License Version 1.0. The

user may obtain a copy of the license at:

http://interbase.com/IPL.html.

The Software is offered solely under the terms of the Interbase Public

License Version 1.0.

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How to Use this Supplement

This supplement is to be used in conjunction with the cobas s 201 system

Operator’s Manual.

Before using the Docking Station, it is essential that the Warnings,

Cautions, and Safety Requirements that are contained in that manual and

in this supplement are read and understood by the user.

Refer to the section titled Symbols on the following page for a description

of the warning symbols and caution symbols that appear in this

supplement.

This supplement contains the following sections:

Preface (Preface) summarizes safety precautions necessary when

operating the system.

Section 1 (Workflow) outlines the procedures that are different

during routine operation of the cobas

s 201 system with

the Docking Station.

Section 2 (Docking Station) describes the major components of the

Docking Station.

Index

Preface

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Conventions Used in This Supplement

Text Conventions To convey information readily and consistently, certain text conventions

are used throughout this supplement. These text conventions are as

follows:

Text convention Used for

Numbered lists Numbered procedures that should be

implemented in order during an operation:

1 Turn power switch on.

2 Click on File.

Bold typeface, lower case Emphasis of any term or component that is

being described:

A profile is a user-defined series of tests to be

performed.

Italics Designating another section of this

Operator’s Manual that should be consulted:

Details concerning order entry are outlined

in the Orders section of this Manual.

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Symbols Certain symbols are used throughout this supplement to provide a ready

visual reference. These symbols are as follows:

Symbol Used for

Information note. Designates a note that

provides additional information concerning

the current topic or procedure.

Important note. Designates an important

note that must be reviewed and understood.

Danger. Indicates a direct danger that, if not

avoided, may result in death or serious

injury.

War ning. Indicates a possible hazardous

situation that, if not avoided, may result in

death or serious injury.

Caution. Indicates a possible hazardous

situation which, if not avoided, may result in

personal injury and/or in damage to the

system.

Warning Potential Biohazardous Material.

Indicates a possible hazardous situation due

to biohazardous material that may result in

death or serious injury.

Warning Laser Transmitter. Designates the

presence of a laser transmitter. Do not stare

into the laser transmitter.

Warning Moving Parts. Indicates a possible

hazardous situation. Keep hands away from

moving parts.

Preface

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The following symbols appear on the instrument type plate.

Electrical and electronic equipment marked

with this symbol are covered by the European

directive WEEE. This symbol denotes that

the equipment must not be disposed of in the

municipal waste system.

(WEEE) Directive 2002/96/EC of the

European Parliament and the Council of 27

January 2003 on waste electrical and

electronic equipment

Danger Area. The triangular warning symbol

on the back of the analyzer is a general

reminder that users read the safety

information contained in this manual. Users

must be able to identify specific hazards and

take appropriate action to avoid them.

Symbol Used for

Caution: Refer to accompanying documents.

Manufacturer of device.

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Glossary

The terminology that is used in this supplement is generally the same as

that used in clinical laboratories. Certain specific terms, however, are used

for description of an operation or a component.

Refer to the cobas s 201 system Operator’s Manual for a summary of

terms that are used with this system and their definitions.

A summary of the terms used in this Supplement and their definitions is

provided below:

K-carrier Reusable metallic holder that accommodates

up to 24 K-tubes that contain PCR-ready

samples for analysis on the COBAS

TaqMa n

Analyzer.

K-tube Kinetic tube. The disposable sample tube that

is used to contain a prepared sample. K-tubes

come prepackaged in a covered K-tube rack.

Multicarrier Holds a K-carrier for transport from the

COBAS

AmpliPrep Instrument to the

COBAS

TaqMa n

Analyzer by the Docking

Station and vice versa.

SK24 rack Reusable rack that holds S-tubes or K-tubes

in barcode clips. The SK24 rack loads and

unloads samples throughout the pipetting,

extraction, and amplification/detection

process.

Thermal Cycler Programmable temperature block in the

COBAS

TaqM an

Analyzer. The thermal

cycler rapidly changes temperature according

to the amplification profile defined in the test

definition files.

Preface

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Units

The following measurement abbreviations are used:

°C Degrees Centigrade

°F Degrees Fahrenheit

CAN Canada.

CE Conformité Européenne

cm Centimeters

CSA Canadian Standards Association

EN European Normative

FCC Federal Communications Commission

IEC International Electrotechnical Commission

in Inches

kg Kilogram

lb Pounds (weight)

LED Light Emitting Diode

μL microliters(10

-6

liters)

UL Underwriters Laboratories (USA)

VA Volt-Ampères (power consumption)

VA C Volts (alternating current)

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Operational Precautions and Limitations

Safety Requirements

The safety precautions that are necessary when installing, operating and

servicing the Docking Station are summarized in the following sections

of this manual. It is important that you carefully read and understand

the statements regarding safety contained in these sections. This

information should also be made available for new employees and for

future reference.

Disposal Recommendations

All electrical and electronic products should be disposed of separately

from the municipal waste system. Proper disposal of your old appliance

prevents potential negative consequences for the environment and

human health.

Disposal of the Instrument

The instrument must be treated as biologically contaminated-

hazardous waste. Decontamination (i.e., a combination of processes,

including cleaning, disinfection and/or sterilization) is required before

reuse, recycling or disposal.

Dispose the instrument according to local and/or labor regulations. For

more information, contact your local Roche Support personnel.

Disposal of Control Unit Components

Components of your control unit such as the computer, monitor,

keyboard, etc. which are marked with the crossed-out wheeled bin

symbol are covered by the European Directive 2002/96/EC (WEEE).

These items must be disposed of via designated collection facilities

appointed by government or local authorities.

For more information about disposal of your old product, please

contact your city office, waste disposal service or your local Roche

Support personnel.

Constraint

It is left to the responsible laboratory organization to determine

whether control unit components are contaminated or not. If

contaminated, treat in the same way as the instrument.

Preface

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Warnings

Intended Use

The Docking Station connects the COBAS

AmpliPrep Instrument to the

COBAS

TaqMa n

Analyzer and fully automates sample preparation,

amplification, and detection.

This supplement contains instructions for using the Docking Station with

the cobas s 201 system. This supplement should be used in conjunction

with the cobas s 201 system Operator’s Manual.

WARNING

For service, contact your Roche Service representative, who is trained

and qualified to perform the necessary servicing.

WARNING

Never open the Docking Station while a run is in progress. Failure to

follow this procedure can result in potential injury to the operator.

WARNING

After the Docking Station is installed by a Roche Service representative,

the COBAS

AmpliPrep Instrument and the COBAS

TaqMa n

Analyzer must not be moved. Movement of the docked system can

cause the Docking Station to become non-operational.

Electrical safety

The Docking Station is designed in accordance with safety standard EN/

IEC 61010-1. Grounding of the instrument and those surfaces the user

can come into contact with is provided by a grounded cable in

accordance with Protection Class I (IEC).

Users should not perform any servicing.

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Roche cobas s 201 system User manual

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