Roche cobas s 201 system User manual

Brand: Roche

Model: cobas s 201 system

Type: User manual

Instrument Manual

Version 3.0

For use with the cobas s 201 system

Hamilton MICROLAB

STAR IVD / STARlet IVD

pipettor

Roche Diagnostics

Instrument Manual · Version 3.0 3

Hamilton MICROLAB STAR IVD / STARlet IVD pipettor

Publication information

Revision history

Edition notice This publication is for users of the Hamilton MICROLAB STAR IVD / STARlet IVD

pipettor component of the cobas s 201 system.

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 Instrument Manual contains all information about the product, including the

following:

o Routine operation

o Service

o Safety

o Troubleshooting information

o Background information

Training Do not carry out operation tasks or service 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.

War ranty Any customer modification to the instrument renders the warranty or service

agreement null and void.

Software updates are performed by Roche service representatives.

Publication

version

Software version Revision date Change description

1.0 PDM software 3.0 August 2010 Original document

1.1 PDM software 3.0 March 2013 Document information, contact addresses, barcode

support

2.0 PDM software 3.0 and 4.0 July 2014 Add PDM software 4.0 and Configuration E options

3.0 PDM software 4.1 January 2019 Update to PDM software 4.1.

Configuration D removed.

What is new in publication version 3.0 on page 9

General attention

To avoid serious or fatal injury, ensure that you are familiar with the system and safety

information before you use the system.

o Pay particular attention to all safety precautions.

o Always follow the instructions in this publication.

o Do not use the instrument in a way that is not described in this publication.

o Store all publications in a safe and easily accessible place.

Hamilton MICROLAB STAR IVD / STARlet IVD pipettor

Roche Diagnostics

4 Instrument Manual · Version 3.0

Trademarks The following trademarks are acknowledged:

ROCHE, AMPLIPREP, TAQMAN, COBAS, and COBAS S are trademarks of Roche.

MICROLAB is a registered trademark of Hamilton Bonaduz AG.

Microsoft and Windows are either registered trademarks or trademarks of Microsoft

Corporation in the United States or other countries.

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 Hamilton MICROLAB STAR IVD / STARlet IVD pipettor meets the

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.

Compliance with the applicable directive(s) is provided by means of the Declaration

of Conformity.

The following marks demonstrate compliance:

Contact addresses

Complies with the provisions of the applicable EU directives.

For in vitro diagnostic use.

Roche Molecular Systems, Inc.

1080 US Highway 202 South

Branchburg, NJ 08876

USA

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Hamilton Bonaduz AG

Via Crusch 8

7402 Bonaduz

Switzerland

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Instrument Manual · Version 3.0 5

Hamilton MICROLAB STAR IVD / STARlet IVD pipettor

Table of contents

Publication information 3

Contact addresses 4

Table of contents 5

Intended use 7

Symbols and abbreviations 8

What is new in publication version 3.0 9

System Description Part A

1Safety

Safety classifications A–5

Safety precautions A–6

Safety summary A–8

Safety labels on the instrument A–13

Disposal of the instrument A–15

2Overview

Technical specifications A–19

Locating the pipettor A–23

Connecting power and network cables A–24

3 Instrument

Pipetting overview A–26

Platforms A–27

Autoload tray A–29

Autoload unit with barcode reader A–30

Pipetting arm A–31

Teaching needles A–33

Main switch (ON/OFF) A–33

Carriers A–34

Consumables A–39

Operation Part B

4Operation

Overview B–5

Safety information B–5

Workf low B –6

Maintenance Part C

5Service

Safety information C–5

Hamilton MICROLAB STAR IVD / STARlet IVD

pipettor maintenance C–6

Verification procedures C–14

Troubleshooting Part D

6 Troubleshooting

Error Messages D–4

Troubleshooting D–8

Glossary Part E

Glossary E–3

Index Part F

Index F–3

Revisions Part G

Roche Diagnostics

6 Instrument Manual · Version 3.0

Hamilton MICROLAB STAR IVD / STARlet IVD pipettor

Roche Diagnostics

Instrument Manual · Version 3.0 7

Hamilton MICROLAB STAR IVD / STARlet IVD pipettor

Intended use

The Hamilton MICROLAB STAR IVD / STARlet IVD pipettor automates pipetting

of Primary Pools, Library Plates (optional), and pipetting of controls. The instrument

is also used to prepare Secondary Pools when they are required.

The Hamilton MICROLAB STAR IVD / STARlet IVD pipettor is used for pipetting

human plasma to be screened for infectious agents using polymerase chain reaction

(PCR) amplification technology and 5’ nuclease real-time detection technology.

The Hamilton MICROLAB STAR IVD / STARlet IVD pipettor is intended to be used

by laboratory professionals trained in laboratory techniques and on the use of the

system.

This manual is to be used in conjunction with the cobas s 201 system Operator’s

Manual.

NOTICE

o This manual is for use with PDM software 4.1 or higher.

o This manual is not to be used for applications performed using versions of the PDM

software earlier than 4.1.

Hamilton MICROLAB STAR IVD / STARlet IVD pipettor

Roche Diagnostics

8 Instrument Manual · Version 3.0

Symbols and abbreviations

Symbols used in the publication

Symbols used on product

Abbreviations The following abbreviations are used.

Symbol Explanation

a Start of procedure

End of procedure

o List item

Cross-reference

f Call-up (software reference)

Tip

Electrical and electronic equipment marked with this symbol are

covered by the European directive WEEE.

The symbol denotes that the equipment must not be disposed of in

the municipal waste system.

Symbol Explanation

Global Trade Item Number. Used on the type plate of the instrument.

μL Microliter (10

-6

liters)

AAmpere

AC Alternating current

ANSI American National Standards Institute

cm Centimeter

CO-RE Compression-induced O-ring expansion

DNA Deoxyribonucleic acid

EC European Community

EN European Normative

ft Feet

Hz Hertz

IEC International Electrotechnical Commission

in Inch

ISO International Organization for Standardization

IVD In vitro diagnostics

kg Kilogram

lb Pound (weight)

LED Light emitting diode

LLD Liquid level detection

mL Milliliter (10

-3

liters)

mm Millimeter (10

-3

meters)

PCR Polymerase chain reaction

PDM Pooling and Data Management

RF Radio frequency

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Instrument Manual · Version 3.0 9

Hamilton MICROLAB STAR IVD / STARlet IVD pipettor

What is new in publication version 3.0

General changes o The publication was updated to PDM software 4.1.

o Information about Configuration D was removed from the publication.

Front matter and preface Front matter and preface have been updated according to the new Roche Diagnostics

standards.

o The following sections were added:

Training on page 3

Images on page 3

Feedback on page 4

Symbols used on product on page 8

o The following sections were updated:

Edition notice on page 3

Where to find information on page 3

War rant y on page 3

Trademarks on page 4

Symbols used in the publication on page 8

o The approvals were updated and expanded:

Approvals on page 4

o The company name in the copyright information was adapted:

o The sections How to use this manual and Text conventions were removed.

RMEC Roche-manufactured external control

TADM Total aspiration dispense monitoring

UDEC User-defined external control

UL Underwriters Laboratories Inc.

UPS Uninterruptible power supply

USB Universal serial bus

VVolt

WWatt

WEEE Waste from electric and electronic equipment

Hamilton MICROLAB STAR IVD / STARlet IVD pipettor

Roche Diagnostics

10 Instrument Manual · Version 3.0

1 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A–3

2 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A–17

3 Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A–25

System Description

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Instrument Manual · Version 3.0 A-3

Hamilton MICROLAB STAR IVD / STARlet IVD pipettor 1 Safety

Table of contents

Safety

In this chapter, you will find information on the safe operation of the Hamilton

MICROLAB STAR IVD / STARlet IVD pipettor.

Safety classifications ........................................................................................................ A–5

Safety precautions ........................................................................................................... A–6

Operator qualification .............................................................................................. A–6

Safe and proper use of the instrument ................................................................... A–6

Miscellaneous safety precautions ............................................................................ A–7

Safety summary ............................................................................................................... A–8

Warning messages .................................................................................................... A–8

Electrical safety .................................................................................................... A–8

Optical safety ....................................................................................................... A–8

Biohazardous materials ...................................................................................... A–9

Waste .................................................................................................................... A–9

Explosion and fire risk ..................................................................................... A–10

Caution messages .................................................................................................... A–10

Mechanical safety .............................................................................................. A–10

Proper identification ........................................................................................ A–10

Contamination .................................................................................................. A–11

Samples and consumables ............................................................................... A–11

Notices ...................................................................................................................... A–12

Moving parts ..................................................................................................... A–12

Circuit breakers and fuses ............................................................................... A–12

Pipetting channels ............................................................................................ A–12

Proper loading ................................................................................................... A–12

Safety labels on the instrument ................................................................................... A–13

Disposal of the instrument ........................................................................................... A–15

In this chapter

Chapter

Roche Diagnostics

A-4 Instrument Manual · Version 3.0

1 Safety Hamilton MICROLAB STAR IVD / STARlet IVD pipettor

Table of contents

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Instrument Manual · Version 3.0 A-5

Hamilton MICROLAB STAR IVD / STARlet IVD pipettor 1 Safety

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 icons and their

meanings:

These symbols and signal words are used for specific hazards:

For more information about the product safety labels, see Safety labels on the instrument

on page A-13

Important information that is not safety relevant is indicated by the following

symbol:

The safety alert symbol by itself without a signal word is used to promote awareness to

hazards that are generic or to direct the reader to safety information provided elsewhere in

the document.

WARNING

Indicates a hazardous situation which, if not avoided, can result in death or serious injury.

CAUTION

Indicates a hazardous situation which, if not avoided, can result in minor or moderate

injury.

NOTICE

Indicates a hazardous situation which, if not avoided, can result in damage to equipment.

Tip

Indicates additional information on correct use of the instrument or useful tips.

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1 Safety Hamilton MICROLAB STAR IVD / STARlet IVD pipettor

Safety precautions

Operator qualification

Operators are required to have a sound knowledge of relevant guidelines and

standards, as well as the information and procedures contained in the Instrument

and Operator’s Manuals.

o Do not perform operation and maintenance unless you have been trained.

o Carefully follow the procedures specified in the Instrument and Operator’s

Manuals for the operation and maintenance of the instrument.

o Leave maintenance, installation, or service that is not described in the Instrument

and Operator’s Manuals to trained Roche service personnel.

o Follow standard laboratory practices, especially when working with biohazardous

material.

Safe and proper use of the instrument

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. This is particularly important when dealing with a malfunction of the

instrument where the risk of contamination from spilled liquids exists.

o Wear a face shield if there is a chance of splash or splatter.

Installation o Installation must be performed by trained Roche service personnel only.

Correct use o Use the Hamilton MICROLAB STAR IVD / STARlet IVD pipettor only for

pipetting samples as described in the cobas s 201 system Operator’s Manual.

Operating conditions o Operation outside of the specified ranges may lead to incorrect results or

malfunction of the instrument.

For ranges, see Technical specifications on page A-19

o During operation, the instrument must be shielded from sunlight and intense

artificial light.

o Position the instrument in the laboratory in a way permitting personnel to access

the front and sides of the instrument.

o Maintenance (daily maintenance, weekly maintenance, and periodic verification

performed by Roche service personnel) is a mandatory part of the work routine.

o Keep the Instrument Manual in a safe place to ensure it is not damaged and

remains available for use. This manual must be easily accessible at all times.

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.

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Hamilton MICROLAB STAR IVD / STARlet IVD pipettor 1 Safety

Safety precautions

Approved parts Use of nonapproved parts or devices may result in malfunction of the instrument and

may render the warranty null and void. Only use parts and devices approved by

Roche Diagnostics. Only certified technicians are authorized to perform mechanical

maintenance on the instrument.

Miscellaneous safety precautions

Power interruption A power failure or momentary drop in voltage may damage the instrument or lead to

data loss. Perform regularly backups of measurement results. An uninterruptible

power supply (UPS) is recommended.

Electromagnetic fields The Hamilton MICROLAB STAR IVD / STARlet IVD pipettor conforms to

European norms with regards to interference immunity. However, if the Hamilton

MICROLAB STAR IVD / STARlet IVD pipettor is subjected to electromagnetic RF

fields, or if static electricity is discharged directly onto the Hamilton MICROLAB

STAR IVD / STARlet IVD pipettor, its liquid level detection ability may be negatively

affected. It is therefore recommended that the Hamilton MICROLAB STAR IVD /

STARlet IVD pipettor is kept away from other equipment that emits electromagnetic

RF fields in the laboratory, and that static electricity is minimized in its immediate

environment.

Relocation and transportation Never lift a fully installed instrument to transport it from one place to another. It

must be reinstalled in the new work location by an authorized Roche service

technician. The instrument weighs more than 150 kg. Take necessary precautions

when transporting the instrument. Leave relocation and transportation to personnel

trained or authorized by Roche.

For additional details, see Locating the pipettor on page A-23

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1 Safety Hamilton MICROLAB STAR IVD / STARlet IVD pipettor

Safety summary

This safety summary contains the most important general warning and caution

messages. Additionally, you will find specific safety information at the beginning of

Chapter 4 Operation and Chapter 5 Service

Warning messages

Electrical safety

Optical safety

WARNING

List of warning messages

Before operating the instrument, read the warning messages contained in this summary

carefully. Failure to observe them may result in death or serious injury.

Electrical shock by electronic equipment

o Do not attempt to work in any electronic compartment.

o Do not remove any cover of the instrument other than those specified in this

Instrument Manual.

o Do not touch any parts of the instrument other than those specified. Especially do not

touch any power supply parts.

o Never remove the middle grounding prong from the power cable or defeat its purpose

by using an ungrounded adapter.

o Installation, service, and repair must only be performed by personnel authorized and

qualified by Roche.

o Before removing a mechanical or electrical component, the instrument must first be

switched off and disconnected from the mains power supply and from the workstation.

o Observe the safety labels on the instrument.

Loss of sight due to staring into laser beam

o The barcode reader contains a class 2 laser diode.

o Do not stare into the laser transmitter beam when the barcode reader is exposed as

your eyesight may be severely damaged.

o Observe the safety labels on the instrument.

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Hamilton MICROLAB STAR IVD / STARlet IVD pipettor 1 Safety

Safety summary

Biohazardous materials

Waste

For information about disposal of the instrument, see Disposal of the instrument on

page A-15

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.

o Follow standard laboratory practices, especially when working with biohazardous

material.

o If the instrument becomes contaminated, clean it in accordance with the weekly

maintenance procedures given in Chapter 5 Service.

o When working with biohazardous samples, observe and perform the maintenance

procedures, paying particular attention to cleaning and decontamination.

o Wear gloves when handling the pipetting arm and channels, the carriers, racks, and

the tips.

o Any surfaces on which liquid is spilled must be decontaminated. Do not use

disinfecting materials that contain hypochlorite or bleaching fluids.

o If sample or control material comes into contact with your skin, immediately apply

disinfectant, then wash it off using soap and water. Consult a physician.

o Observe the safety labels on the instrument.

Infection by biohazardous waste

The Hamilton MICROLAB STAR IVD / STARlet IVD pipettor drops its used tips into a tip

waste bag. Empty the tip waste bag as soon as it is full.

o 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.

o If any biohazardous material is spilled, wipe it up immediately and apply disinfectant.

o If waste solution comes into contact with your skin, wash it off immediately using water

and apply a disinfectant. Consult a physician.

o Avoid touching discarded tips.

o Observe the safety labels on the instrument.

Contamination of the environment by waste

When disposing of any waste generated by the instrument, do so according to the

appropriate local regulations.

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1 Safety Hamilton MICROLAB STAR IVD / STARlet IVD pipettor

Safety summary

Explosion and fire risk

Caution messages

Mechanical safety

Proper identification

Fire risk through usage of sprays

Spraying liquid on the power supply parts can cause a short circuit and result in a fire.

o Keep the cover closed while the instrument is connected to the mains power supply

and do not use sprays in the vicinity of the instrument.

o Do not spray directly at the autoload unit or at electrical boards or connectors.

o Do not clean the instrument in the vicinity of open flames or devices that can create

sparks.

o Do not use hot air blowers to dry the instrument. The liquids used for cleaning are

flammable.

CAUTION

List of caution messages

Before operating the instrument, read the caution messages contained in this summary

carefully. Failure to observe them may result in minor or moderate injury.

Personal injury due to contact with moving parts

During Hamilton MICROLAB STAR IVD / STARlet IVD pipettor operation, do not place

hands in the way of moving parts or on the working deck. Keep your head and hands away

from the work surface of the Hamilton MICROLAB STAR IVD / STARlet IVD pipettor when

it is in operation – the pipetting arm and channels move fast and it is possible to sustain an

injury. In general, never lean over the Hamilton MICROLAB STAR IVD / STARlet IVD

pipettor when working with it.

o Keep the cover closed while the instrument is operating.

o Do not try to open the locked front cover of the Hamilton MICROLAB STAR IVD /

STARlet IVD pipettor during a run, as the system will stop and this may cause the loss

of data.

o Do not touch any parts of the instrument other than those specified. Keep away from

moving parts during instrument operation.

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

instructions.

o Do not attempt to by-pass any design safety feature. Doing so may result in personal

injury, instrument damage and/or loss of data.

o Observe the safety labels on the instrument.

Incorrect data caused by exchanging sample positions

Do not exchange positions of sample tubes or switch deep-well plates after they have been

identified by the barcode reader. This can result in incorrect test data or a hardware error.

If consumables are improperly positioned or moved after they are identified, it is possible

they will interfere with the movement of the pipetting arm. The system will abort the run if

a hardware error occurs.

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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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