Roche cobas s 201 system User manual

Type
User manual
Instrument Manual
For use with the cobas s 201 system
Hamilton MICROLAB
STAR IVD / STARlet IVD
pipettor
Hamilton MICROLAB STAR IVD / STARlet IVD pipettor
Roche Diagnostics
2 Instrument Manual · Version 1.1
Document information
Revision history
Edition notice This manual 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
manual is correct at the time of printing. The screenshots in this publication have
been added exclusively for the purpose of illustration. Configurable and variable data
such as parameters, results, path names etc. visible therein must not be used for
laboratory purposes.
Any customer modification to the instrument will render the warranty or service
agreement null and void.
Software updates are performed by Roche service representatives.
Intended use 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 not to be used for applications performed using versions of the PDM
software earlier than the 3.0 series.
Copyright © 2013, Roche Diagnostics International Ltd. All rights reserved.
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.
Manual Version Software Version Revision date Changes
1.0 PDM software 3.0 August 2010 Original document
1.1 PDM software 3.0 March 2013 Document information, contact
addresses, barcode support
Roche Diagnostics
Instrument Manual · Version 1.1 3
Hamilton MICROLAB STAR IVD / STARlet IVD pipettor
Compliance is demonstrated by the following marks:
Contact addresses
Complies with the IVD directive 98/79/EC.
Issued by Canadian Standards Association (CSA) for Canada and the US.
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
Hamilton MICROLAB STAR IVD / STARlet IVD pipettor
Roche Diagnostics
4 Instrument Manual · Version 1.1
Roche Diagnostics
Instrument Manual · Version 1.1 5
Hamilton MICROLAB STAR IVD / STARlet IVD pipettor
Table of contents
Document information 2
Contact addresses 3
Table of contents 5
Preface 7
How to use this manual 7
Conventions used in this manual 8
System Description Part A
1 Safety
Safety classifications A–5
Safety precautions A–6
Safety summary A–8
Safety labels on the instrument A–14
Disposal of the instrument A–16
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
Workflow B–6
Maintenance Part C
5Service
Safety information C–5
Hamilton MICROLAB STAR IVD / STARlet IVD
pipettor maintenance C–6
Verification procedu res 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
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6 Instrument Manual · Version 1.1
Hamilton MICROLAB STAR IVD / STARlet IVD pipettor
Roche Diagnostics
Instrument Manual · Version 1.1 7
Hamilton MICROLAB STAR IVD / STARlet IVD pipettor
Preface
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.
This manual is for use with PDM software 3.0. It is to be used in conjunction with the
cobas s 201 system Configuration D Operator’s Manual.
How to use this manual
To help you find information quickly, there is a table of contents at the beginning of
the book and each chapter. In addition, a complete index can be found at the end.
The Instrument Manual for the Hamilton MICROLAB STAR IVD / STARlet IVD
pipettor contains the following chapters:
Preface Summarizes the conventions used in this manual.
Safety Summarizes safety precautions necessary when installing, operating, and servicing
the Hamilton MICROLAB STAR IVD / STARlet IVD pipettor.
Overview Contains the technical specifications for the Hamilton MICROLAB STAR IVD /
STARlet IVD pipettor. Also lists donor tube barcode and Pooling Management
workstation requirements.
Instrument Describes the major hardware components of the Hamilton MICROLAB STAR IVD /
STARlet IVD pipettor and consumables.
Operation Contains a workflow diagram and explains how to load carriers to the pipetting deck.
Service Reviews steps required for regular maintenance of the Hamilton MICROLAB STAR
IVD / STARlet IVD pipettor.
Troubleshooting Contains troubleshooting information and lists error messages.
Glossary Contains definitions for specialized terms used in this manual.
Index Provides a list of reference pages for key terms in this manual.
o Keep this Instrument Manual in a safe place to ensure it is not damaged and remains
available for use.
o This Instrument Manual must be easily accessible at all times.
Hamilton MICROLAB STAR IVD / STARlet IVD pipettor
Roche Diagnostics
8 Instrument Manual · Version 1.1
Conventions used in this manual
This section explains the formatting conventions used in this manual.
Text conventions To convey information readily and consistently, certain text conventions are used
throughout this manual. These text conventions are as follows:
Visual cues are used to help locate and interpret information in this manual quickly.
This section explains formatting conventions used in this manual.
Symbols The following symbols are used:
Text Convention Used for
Numbered lists
Numbered procedures to be implemented sequentially during an
operation:
1. Remove samples from storage.
2. Select the pooling method.
Italics
Designating another section of this manual or the Operator’s Manual
to be consulted.
e
For a description of the warning symbols, refer to the section
titled Symbols
Bold
Terms in the user interface like tab or button names or options are
printed in bold letters.
1. Select the PDM Pooling Wizard Maintenance tab.
2. Select Weekly Maintenance, then click Start.
Symbol Used for
a Start of procedure
End of procedure
o List item
e
Cross-reference
f Call-up (software reference)
Tip
Warning alert symbol
Safety alert
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.
Roche Diagnostics
Instrument Manual · Version 1.1 9
Hamilton MICROLAB STAR IVD / STARlet IVD pipettor
Screen shots The screen representations shown in this publication are for illustrative purposes
only. The screens do not necessarily show valid data.
Abbreviations The following abbreviations are used.
µL Microliter (10
-6
liters)
AAmpere
AC Alternating current
ANSI American National Standards Institute
CAN Canada
cm Centimeter
CO-RE Compression-induced O-ring expansion
CSA Canadian Standards Association
DNA Deoxyribonucleic acid
EC European Community
EN European Normative
FCC Federal Communications Commission
ft Feet
Hz Hertz
IEC International Electrotechnical Commission
in Inch
ISM Industrial, scientific, and medical
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
RMEC Roche-manufactured external control
TADM Total aspiration dispense monitoring
UDEC User-defined external control
UL Underwriters Laboratories Inc.
UPS Uninterruptible power supply
US United States
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 1.1
1 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A–3
2 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A–17
3 Instrument . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A–25
System Description
A
Roche Diagnostics
Instrument Manual · Version 1.1 A-3
Hamilton MICROLAB STAR IVD / STARlet IVD pipettor 1 Safety
Table of c onten ts
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
Interference ................................................................................................... A–13
Safety labels on the instrument ............................................................................... A–14
Disposal of the instrument ...................................................................................... A–16
In this chapter
Chapter
1
Roche Diagnostics
A-4 Instrument Manual · Version 1.1
1 Safety Hamilton MICROLAB STAR IVD / STARlet IVD pipettor
Table of c onten ts
Roche Diagnostics
Instrument Manual · Version 1.1 A-5
Hamilton MICROLAB STAR IVD / STARlet IVD pipettor 1 Safety
Safety classifications
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:
e
For more information about the product safety labels, see Safety labels on the instrument
on page A-14
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.
DANGER
DANGER
Indicates a hazardous situation which, if not avoided, will result in death or serious injury.
WARNING
WARNING
Indicates a hazardous situation which, if not avoided, can result in death or serious injury.
CAUTION
CAUTION
Indicates a hazardous situation which, if not avoided, can result in minor or moderate
injury.
NOTICE
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.
Roche Diagnostics
A-6 Instrument Manual · Version 1.1
1 Safety Hamilton MICROLAB STAR IVD / STARlet IVD pipettor
Safety precautions
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 Configuration D
Operator’s Manual.
Operating conditions o Operation outside of the specified ranges may lead to incorrect results or
malfunction of the instrument.
e
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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Instrument Manual · Version 1.1 A-7
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.
e
For additional details, see Locating the pipettor on page A-23
Roche Diagnostics
A-8 Instrument Manual · Version 1.1
1 Safety Hamilton MICROLAB STAR IVD / STARlet IVD pipettor
Safety summary
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 Pooling
Management 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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Instrument Manual · Version 1.1 A-9
Hamilton MICROLAB STAR IVD / STARlet IVD pipettor 1 Safety
Safety summary
Biohazardous materials
Waste
e
For information about disposal of the instrument, see Disposal of the instrument on
page A-16
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.
Roche Diagnostics
A-10 Instrument Manual · Version 1.1
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

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User manual

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