Roche cobas s 201 system User manual

Brand: Roche

Model: cobas s 201 system

Type: User manual

The Roche cobas s 201 system is a fully automated sample-to-result system for molecular diagnostic testing, designed to provide fast and accurate results for a variety of tests, including infectious disease testing, genetic testing, and oncology testing. With its ability to process up to 96 samples in a single run and deliver results in as little as 3 hours, the cobas s 201 system can help laboratories improve efficiency and reduce turnaround time for molecular testing.

04/2006, version 1.0 0.1

cobas s 201 System 0

Operator’s Manual Supplement

for Use of the Docking Station

P/N: 04875982018-01

0.2 04/2006, version 1.0

This page intentionally left blank.

Preface

04/2006, version 1.0 0.3

Table of Contents

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

..............................................................................................................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 .............................................................1.13

Review Run Messages ........................................................................1.13

Review and Accept Results ...............................................................1.13

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

0.4 04/2006, version 1.0

Revision History

The Docking Station is manufactured by:

Manual Revision Revision Date

1.0 April 2006

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

04/2006, version 1.0 0.5

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, 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.

0.6 04/2006, version 1.0

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 with the

Docking Station.

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

Docking Station.

Preface

04/2006, version 1.0 0.7

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.

0.8 04/2006, version 1.0

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.

Warning. 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

04/2006, version 1.0 0.9

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 Parliment 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.

0.10 04/2006, version 1.0

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

TaqMan

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 TaqMan 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 TaqMan Analyzer. The thermal

cycler rapidly changes temperature according

to the amplification profile defined in the test

definition files.

Preface

04/2006, version 1.0 0.11

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)

VAC Volts (alternating current)

0.12 04/2006, version 1.0

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

04/2006, version 1.0 0.13

Warnings

Intended Use

The Docking Station connects the COBAS AmpliPrep Instrument to the

COBAS TaqMan 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 TaqMan 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.

0.14 04/2006, version 1.0

04/2006, version 1.0 1.1

Workflow 1

Overview

The modified workflow for processing pooled samples on a COBAS

AmpliPrep Instrument that is linked to a COBAS

TaqMan

Analyzer by

means of the Docking Station is shown in

Figure 1.1.

Workflow procedures that are described in this supplement replace

the Extraction, Amplification, and Detection workflow procedures

described in section 2 (Quick Start Guide: Workflow) of the cobas s

201 System Operator’s Manual when a Docking Station is used.

The COBAS AmpliPrep Instrument and the COBAS TaqMan

Analyzer must be connected to the same Data Station for

AMPLILINK software.

Figure 1.1

Extraction, Amplification, Detection Workflow when Using the Docking Station

1.2 04/2006, version 1.0

Perform Startup Procedures

The Data Station for AMPLILINK software is normally left on,

except for a daily restart. If the Data Station is powered off, refer to

the cobas s 201 System Operator’s Manual for startup procedures.

COBAS AmpliPrep Instrument

When using the Docking Station, an empty K-carrier must be

present in each of the two K-carrier park positions of the COBAS

AmpliPrep Instrument. Refer to

page 2.5 for the procedure to place

K-carriers in these positions.

The COBAS AmpliPrep Instrument is normally left in Standby

mode. If the instrument is powered off, refer to the cobas s 201

System Operator’s Manual for startup procedures.

1 Check the status of the wash reagent reservoir. Replace if necessary.

A reservoir icon on the Systems window System tab is red if the

corresponding reservoir is empty.

2 Empty the waste container if it requires emptying.

The waste icon on the Systems window System tab is red if the

waste level is too high.

3 Perform any maintenance that is listed in the Systems window Service Due

tab.

The background on the Systems icon turns yellow and an oil can

appears on the icon when service is due. Perform the

required service before starting the next run.

The system is automatically primed after each service is performed.

Workflow

04/2006, version 1.0 1.3

COBAS TaqMan Analyzer

When using the Docking Station, four empty K-carriers must be

present in positions 9 to 12 of the Reload Area of the COBAS

TaqMan Analyzer. Refer to

page 2.6 for the procedure to place

K-carriers in these positions.

The COBAS TaqMan Analyzer is normally left in Standby mode. If

the analyzer is powered off, refer to the cobas s 201 System

Operator’s Manual for startup procedures.

1 Place 24 empty and capped K-tubes into a K-carrier, and then place the

K-carrier in park position 2 on the left side of the COBAS TaqMan

Analyzer (

page 2.6).

The analyzer must be powered off to perform this step.

If a batch contains fewer than six K-tubes, the COBAS TaqMan

Analyzer uses these empty K-tubes to fill positions 7, 8, 12, 13, 17,

and 18 in the K-carrier. These positions must be occupied to

balance the K-carrier in the thermal cycler.

2 Perform any maintenance that is listed in the Systems window Service Due

tab before starting the next run.

The background on the Systems icon turns yellow and an oil can

appears on the icon when service is due. Perform the

required service before starting the next run.

1.4 04/2006, version 1.0

Load Reagents

The reagents that are required depend upon the cassette status check and

the daily workload.

Reagents should be removed from the refrigerator prior to use.

Reagents should be loaded onto the COBAS AmpliPrep

Instrument immediately after they are removed from storage to

avoid condensation on the barcode labels. Allow the reagents to

equilibrate on the instrument for at least thirty minutes before the

first sample is to be processed.

Do not pool reagents from different lots or from different bottles of

the same lot.

Do not mix reagents (including cassettes) from different kits.

Do not use more than one lot number of reagents for a processing

run on the COBAS AmpliPrep Instrument. A single lot of reagents

must be used for processing all specimens and controls in a batch.

Do not open COBAS AmpliPrep Instrument cassettes and

exchange, mix, remove, or add bottles.

Do not use a kit after its expiration date.

Do not use a kit on more than one COBAS AmpliPrep Instrument.

Do not freeze reagents.

Never attempt to remove a rack when the LED for that rack is red.

1 Obtain the magnetic glass particle (MGP) cassettes that are required.

Reloading of MGP cassettes is not possible during a run due to the

shaking of the rack. The rack containing the MGP cassette is

unlocked after no more tests remain for that cassette, and a new

MGP cassette can be loaded at that time.

2 Place the MGP cassettes on a single reagent rack.

3 Obtain the other cassettes that are required.

4 Place these cassettes on other (up to four) reagent racks.

Other reagent cassettes that are required to complete the orders in

the worklist can be loaded on up to four additional reagent racks.

These reagent racks are loaded in reagent rack positions B through

E, which are not shaken.

Workflow

04/2006, version 1.0 1.5

More than one cassette may be needed for a particular reagent to

complete a run. When the first cassette is depleted, the system will

automatically switch to the next cassette.

5 Open the load panel.

6 Slide the reagent rack containing the magnetic glass particle cassettes onto

rack position A. Slide the rack up to the first pin.

7 Wait for the reagent rack LED to begin flashing green. Then continue

sliding the rack to the back of the instrument. The LED turns orange.

8 Load the other reagent racks on rack positions B through E. When a

complete kit of reagent cassettes has been loaded, all of the reagent rack

LEDs turn solid green.

The COBAS AmpliPrep Instrument scans the reagent rack barcode label

and the reagent cassette barcode labels as each rack is loaded onto the

instrument.

The AMPLILINK software updates the Systems window Cassettes/Samples

tab with the scanned information.

Reagents are supplied in a kit package that includes eight cassettes.

Reagent cassettes from the same kit package must all be loaded

together. If any cassette is missing the remaining cassettes for that

assay are Blocked.

9 Close the load panel.

WARNING

Transfer Head 1 contains a class 1 laser diode. Do not stare into the

laser transmitter.

Figure 1.2

Rack Platform

Shaker Rack

Reagent Racks

SK24 Racks

(A)

(B-E)

(F-H)

1.6 04/2006, version 1.0

Load Consumables

Determine the load requirements. One SPU, one K-tube, and one K-tip

are needed for each S-tube order.

SPUs

1 Obtain the required number of SPUs (up to three full SPU racks can be

loaded).

2 Remove the SPUs from their packaging. Inspect each SPU for defects.

3 Place the SPUs in the SPU racks.

Always make sure that the tips are properly seated. Press down on

the SPU splash guard (not the sample tips) to properly seat the SPU

in the rack. Make sure the sample tips are even.

4 Open the load panel.

5 Position the end of a SPU rack at the front of one of the SPU load

positions. Then slide the SPU rack towards the rear of the instrument

onto the load positions J, K, or L. When the rack is loaded properly, the

SPU LED is green.

When positioning the SPU rack, be sure that the single wells of the

SPU rack are to the right, that the left side of the SPU rack is under

the lip, and that all SPUs are seated properly.

The COBAS AmpliPrep Instrument counts the SPUs and the

Systems window System tab updates supply status as each SPU rack

is loaded onto the system.

Figure 1.3

Filling a SPU Rack

Double Wells

Single Wells

Sample Tip

Splash Guard

WARNING

Transfer Head 1 contains a class 1 laser diode. Do not stare into the

laser transmitter.

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Roche cobas s 201 system User manual

Roche cobas s 201 system User manual

Roche cobas s 201 system User manual

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