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Roche cobas z 480 User manual

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cobas
®
4800 System
cobas z 480 analyzer
Instrument Manual
Software Version 2.1
cobas® 4800 System
cobas z 480 analyzer
Roche Diagnostics
2 Instrument Manual · Version 1.2
Document information
Revision history
Edition notice
This manual is for users of the cobas z 480 analyzer which is part of the cobas
®
4800
System.
Every effort has been made to ensure that all the information contained in this
manual is correct at the time of printing. However, Roche reserves the right to make
any changes necessary without notice as part of ongoing product development.
Any customer modification to the analyzer will render the warranty or service
agreement null and void.
Software updates are done by Roche Service representatives.
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.
Intended use The analyzer including dedicated software for IVD use is a plate-based automated
amplification and detection system for nucleic acids. The analyzer is intended to be
used as an in-vitro diagnostic or screening system providing real time PCR
amplification and detection for human samples within the system. The analyzer is to
be used by laboratory professionals trained in laboratory techniques and by
instruction on the use of the analyzer.
The system including dedicated software for IVD use is intended to be used as an in-
vitro diagnostic or screening system providing amplification and detection of specific
targets from human samples. The system is to be used by laboratory professionals
trained in laboratory techniques and by instruction on the use of the system.
It is important that the operator reads this manual and the test-specific Operator’s
Manual thoroughly before using the system.
Copyright © 2009-2015 F. Hoffmann-La Roche Ltd. All rights reserved.
Trademarks The following trademarks are acknowledged:
COBAS, COBAS Z, and LIFE NEEDS ANSWERS are trademarks of Roche.
All other trademarks are the property of their respective owners.
Feedback Every effort has been made to ensure that this manual fulfills the intended purpose as
mentioned above. All feedback on any aspect of this manual is welcome and will be
considered during updates. Please contact your Roche representative, should you
have any such feedback.
Instrument approvals The analyzer meets the protection requirements laid down in IVD Directive
98/79/EC.
Furthermore, the analyzer is manufactured and tested according to the following
international standards:
Manual version Software version Revision date Changes
1.1 2.1 May 2013 Updated to 2.1
1.2 2.1 February 2015 Minor update to the
description of the
consumables.
Table 1 Revision history
Roche Diagnostics
Instrument Manual · Version 1.2 3
cobas® 4800 System
cobas z 480 analyzer
o IEC 61010-1
o IEC 61010-2-101
o UL 61010-1
o CAN/CSA C22.2 No. 61010-1
This manual meets the European Standard EN ISO 18113-3.
Compliance is demonstrated by the following marks:
Contact addresses
Complies with the IVD directive 98/79/EC.
Issued by underwriters laboratories, Inc. (UL) for Canada and the US.
CUS
®
Roche Molecular Systems Inc.
Building 500
1080 U.S. Highway 202
Branchburg, NJ 08876
U.S.A.
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
cobas® 4800 System
cobas z 480 analyzer
Roche Diagnostics
4 Instrument Manual · Version 1.2
Roche Diagnostics
Instrument Manual · Version 1.2 5
cobas® 4800 System
cobas z 480 analyzer
Table of contents
Document information 2
Contact addresses 3
Table of contents 5
Preface 7
How to use this manual 7
Where to find information 7
Conventions used in this manual 7
System description
1 General safety information
Safety classifications 15
Safety precautions 16
Safety summary 18
Safety labels on the system 24
Disposal 25
2 Overview
System overview 29
3 Hardware
Analyzer 35
Control unit 39
4 Software
Basic software elements 45
Database 53
Operation
5 Operation
Safety information 59
Operation 60
Configuration
6 Configuration
Configuration 67
User management 72
Exporting support data 77
Result counters 78
Maintenance
7 Maintenance
Safety information 83
Analyzer maintenance 84
Troubleshooting
8 Troubleshooting
Overview 99
Messages work area 101
About result flags 104
General troubleshooting 106
Hardware troubleshooting 108
Glossary
9 Glossary
Index
Index 115
Revisions
Roche Diagnostics
6 Instrument Manual · Version 1.2
cobas® 4800 System
cobas z 480 analyzer
Roche Diagnostics
Instrument Manual · Version 1.2 7
cobas® 4800 System
cobas z 480 analyzer
Preface
This manual covers the analyzer that is used for amplification and detection using
real time PCR within the system.
How to use this manual
Q
o Keep this manual in a safe place to ensure that it is not damaged and remains available
for use.
o This manual should be easily accessible at all times.
To help you find information quickly, there is a table of contents at the beginning of
the manual and each chapter. In addition, a complete index can be found at the end
of the manual.
Where to find information
In addition to this manual, the following documents are also provided to assist in
finding desired information quickly:
Test-specific Operator’s Manuals For each test, there is a specific Operator’s Manual which describes how to prepare
and perform a run, and how to handle results.
Test-specific package insert The test-specific package insert provides information on preparation and handling of
the reagent and DNA isolation kit as well as on manual PCR setup of the microwell
plate.
Conventions used in this manual
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:
Symbol Used for
P Start of procedure
S End of procedure
o List item
U Cross-reference
h Call-up (software reference)
Table 2 Symbols used
cobas® 4800 System
cobas z 480 analyzer
Roche Diagnostics
8 Instrument Manual · Version 1.2
Abbreviations The following abbreviations are used:
Product names Except where the context clearly indicates otherwise, this manual uses the following
descriptions:
Q Tip
Safety alert
Electrical and electronic equipment marked with this symbol are
covered by the European Directive 2002/96/EC on waste electrical
and electronic equipment (WEEE).
The symbol denotes that the equipment must not be disposed of in
the municipal waste system.
Symbol Used for
Table 2 Symbols used
Abbreviation Definition
AD Amplification and detection
ANSI American National Standards Institute
cc cubic centimeter
CSA Canadian Standards Association
dBA decibel weighted against the A-frequency response curve. This curve
approximates the audible range of the human ear.
EC European community
e.g. exempli gratia – for example
EN European standard
i.e. id est – that is to say
IEC International Electrical Commission
IVD In vitro diagnostic
KVA kilovolt-Ampere
LED Light Emitting Diode
MWP Microwell plate
n/a not applicable
PCR Polymerase Chain Reaction
UL Underwriters Laboratories Inc.
Table 3 Abbreviations
Product name Abbreviation
cobas® 4800 software software
cobas z 480 analyzer
analyzer
cobas
®
4800 System
system
Table 4 Product names
Roche Diagnostics
Instrument Manual · Version 1.2 9
cobas® 4800 System
cobas z 480 analyzer
cobas® 4800 System
cobas z 480 analyzer
Roche Diagnostics
10 Instrument Manual · Version 1.2
System description
1 General safety information.............................................................................................................. 13
2 Overview .......................................................................................................................................... 27
3 Hardware.......................................................................................................................................... 33
4 Software............................................................................................................................................ 43
Roche Diagnostics
Instrument Manual · Version 1.2 13
cobas® 4800 System 1 General safety information
Table of contents cobas z 480 analyzer
General safety information 1
In this chapter, you will find information on the safe operation of the system.
In this chapter
Chapter
1
Safety classifications.............................................................................................................15
Safety precautions.................................................................................................................16
Operator qualification...................................................................................................16
Safe and proper use of the system................................................................................16
Miscellaneous safety precautions.................................................................................17
Safety summary ....................................................................................................................18
Warning messages..........................................................................................................18
Electrical safety.........................................................................................................18
Biohazardous materials ...........................................................................................19
Waste..........................................................................................................................19
Explosion and fire risk ............................................................................................19
Reagents and consumables .....................................................................................20
Caution messages...........................................................................................................20
Mechanical safety.....................................................................................................20
Reagents and consumables .....................................................................................20
Carryover ..................................................................................................................21
Interfering substances in samples ..........................................................................21
Hot surfaces ..............................................................................................................21
Malfunction due to interfering electromagnetic fields .......................................21
Incorrect results due to two barcode labels or incorrect specimen labeling....22
Incorrect results due to wrongly typed sample IDs.............................................22
Data security.............................................................................................................22
Notices .............................................................................................................................23
Moving parts.............................................................................................................23
Circuit breakers and fuses.......................................................................................23
Spillage.......................................................................................................................23
Safety labels on the system ..................................................................................................24
Safety labels on the analyzer .........................................................................................24
Disposal .................................................................................................................................25
Disposal of the analyzer ................................................................................................25
Roche Diagnostics
14 Instrument Manual · Version 1.2
1 General safety information cobas® 4800 System
Table of contents cobas z 480 analyzer
Disposal of control unit components ..........................................................................25
Roche Diagnostics
Instrument Manual · Version 1.2 15
cobas® 4800 System 1 General safety information
cobas z 480 analyzer 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 meanings and icons:
Safety information
r The safety alert symbol by itself without a signal word is used to promote awareness to
hazards which are generic or to direct the reader to safety information provided
elsewhere in the document.
These symbols and signal words are used for specific hazards:
WARNING
WARNING
r Indicates a hazardous situation which, if not avoided, could result in death or serious
injury.
CAUTION
CAUTION
r Indicates a hazardous situation which, if not avoided, could result in minor or moderate
injury.
NOTICE
NOTICE
r Indicates a hazardous situation which, if not avoided, could result in damage to
equipment.
U For more information about product safety labels, see Safety labels on the system (p. 24)
Important information which is not safety relevant is indicated by the following
symbol:
Q
Tip
Indicates additional information on correct use of the system or useful tips.
Roche Diagnostics
16 Instrument Manual · Version 1.2
1 General safety information cobas® 4800 System
Safety precautions cobas z 480 analyzer
Safety precautions
Safety information
r 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.
Operator qualification
Operators are required to have a sound knowledge of relevant guidelines and
standards as well as the information and procedures contained in all relevant
manuals.
o Do not carry out operation and maintenance unless you have been trained by
Roche Diagnostics.
o Carefully follow the procedures specified in all relevant manuals for operation
and maintenance.
o Leave maintenance, installation, or service that is not described in the manuals to
trained Roche Service representative.
o Follow standard laboratory practices, especially when working with biohazardous
material.
Safe and proper use of the system
Personal protective equipment o Wear appropriate protective equipment, including, but not limited to, safety
glasses with side shields, fluid resistant laboratory coat, and approved disposable
gloves.
o Wear a face shield if there is a chance of splash or splatter.
Accuracy/precision of measured
results
o Do not use reagents that have exceeded their expiry date, otherwise inaccurate
data may be obtained.
o For diagnostic purposes always assess the results in conjunction with the patient’s
medical history, clinical examination, and other findings.
o Each laboratory must verify that analyzer and reagent performance meets the
published specifications.
Installation o Unpacking and installation must be performed by trained Roche Service
representative only.
o Leave installation that is not described in this manual or the test-specific
Operator’s Manuals to a trained Roche Service representative.
Operating conditions o Operation outside of the specified ranges, e.g. with excessive environmental
temperature and/or humidity, may lead to incorrect results or malfunction of the
analyzer.
o Use the analyzer as indicated in the technical specifications.
o Make sure that the ventilation openings remain unobstructed at all times.
Roche Diagnostics
Instrument Manual · Version 1.2 17
cobas® 4800 System 1 General safety information
cobas z 480 analyzer Safety precautions
o Perform maintenance according to the specified intervals to maintain the
operating conditions.
o Keep all manuals in a safe place to ensure that it is not damaged and remains
available for use. All manuals must be easily accessible at all times.
Approved parts Use of non-approved parts or devices may result in malfunction of the analyzer and
may render the warranty null and void. Only use parts and devices approved by
Roche Diagnostics.
Third-party software Installation of any third-party software that is not approved by Roche Diagnostics
may result in incorrect behavior of the system or the software. Do not install any
non-approved software.
Miscellaneous safety precautions
Power interruption A power failure or momentary drop in voltage may lead to data loss. Operation with
an uninterruptible power supply (UPS) is strongly recommended. Check the UPS
regularly to make sure it functions properly.
If there is a power failure, the analyzer is disconnected from the control unit. The
displayed maintenance status of the analyzer may not be correct. To get the correct
maintenance status, refresh the analyzer under Overview > System > cobas z480 tab.
Relocation and transportation Do not attempt to relocate or transport the analyzer. Leave relocation and
transportation to personnel trained or authorized by Roche.
U For additional details, see Disposal (p. 25)
Data backup There is an automatic backup process that stores the data on the D drive. It is the
customers responsibility to perform regular backups of all measurement results.
Roche Diagnostics
18 Instrument Manual · Version 1.2
1 General safety information cobas® 4800 System
Safety summary cobas z 480 analyzer
Safety summary
This safety summary contains the most important and general warning and caution
messages. Additionally, you will find specific safety information at the beginning of
Part Operation (p. 57) and Part Maintenance (p. 81) and in the test-specific
Operator’s Manuals.
U For more information about the safe use of the system, refer to the test-specific package
insert.
Warning messages
WARNING
List of warning messages
r Before operating the system, read the warning messages contained in this summary
and in all relevant manuals carefully. Failure to observe them may result in death or
serious injury.
Electrical safety
WARNING
Electrical shock by electronic equipment
r Do not attempt to work in any electronic compartment.
r Do not remove any cover of the analyzer other than those specified in this manual or
the test-specific Operator’s Manual.
r Do not touch any parts of the analyzer other than those specified. Especially do not
touch any power supply parts.
r Never remove the middle grounding prong from the mains cable or defeat its purpose
by using an ungrounded adapter.
r Installation, service, and repair must only be performed by personnel authorized and
qualified by Roche.
r Observe the system safety labels as illustrated in section Safety labels on the system
(p. 24)
Roche Diagnostics
Instrument Manual · Version 1.2 19
cobas® 4800 System 1 General safety information
cobas z 480 analyzer Safety summary
Biohazardous materials
WARNING
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. Therefore, universal precautions should be taken when handling
and processing samples.
r Follow standard laboratory practices, especially when working with biohazardous
material.
r Do not open the thermal block cycler door during operation.
r Be sure to wear appropriate protective equipment, including, but not limited to, safety
glasses with side shields, fluid resistant laboratory coat, and approved disposable
gloves.
r Wear a face shield if there is a chance of splash or splatter.
r If any biohazardous material is spilled, wipe it up immediately and apply disinfectant.
r If sample or liquid waste comes into contact with your skin, wash it off immediately
with soap and water, and apply a disinfectant. Consult a physician.
Waste
WARNING
Infection by biohazardous waste
Liquid and solid waste originates from samples collected in media that inactivate
potentially biohazardous material. However, as with all human-derived solutions, universal
precautions should be taken when handling waste.
Contact with liquid waste or used pipetting tips may result in infection. All materials and
mechanical components that come into contact with waste are potentially biohazardous.
Therefore, universal precautions should be taken when handling waste.
r Wear protective equipment. Take extra care when working with protective gloves;
these can easily be pierced or cut which can lead to infection.
r If any biohazardous material is spilled, wipe it up immediately and apply disinfectant.
r If liquid waste comes into contact with your skin, wash it off immediately with soap and
water, and apply a disinfectant. Consult a physician immediately.
r Observe the system safety labels as illustrated in section Safety labels on the system
(p. 24)
WARNING
Contamination of the environment by liquid waste and solid waste
The waste generated during the procedure is potentially biohazardous.
r When disposing of any liquid or solid waste, do so according to the appropriate local
regulations.
U For information about disposal, see Disposal (p. 25)
Explosion and fire risk
WARNING
Explosion through sparks
Hazard of explosion through sparks.
r Keep all potentially flammable or explosive material (e.g. anesthetic gas) away from the
analyzer.
Roche Diagnostics
20 Instrument Manual · Version 1.2
1 General safety information cobas® 4800 System
Safety summary cobas z 480 analyzer
WARNING
Fire risk through usage of sprays
Spraying liquid on the power supply parts can cause a short circuit and result in a fire.
r During fire-fighting operations disconnect the equipment from the main power supply.
r Do not remove the analyzer’s cover while the analyzer is connected to the main power
supply, and do not use sprays in the vicinity of the analyzer.
Reagents and consumables
WARNING
Invalid results due to expired reagents and consumables
Data obtained using expired reagents and consumables are not reliable. Reagents are
supplied in a kit package with a label that indicates the expiry date. The expiry date of
microwell plate and sealing film is printed on their package label.
r Use only Roche consumables designed for use on the system.
r Do not reuse consumables. All consumables are designed for one time use only.
r Inspect consumables before use. Do not use damaged consumables.
r Do not use reagents and consumables that have exceeded their expiry dates. Replace
expired reagents and consumables with unexpired reagents and consumables before
sample processing.
Caution messages
CAUTION
List of caution messages
r Before operating the system, read the caution messages contained in this summary
and in all relevant manuals carefully. Failure to observe them may result in minor or
moderate injury.
Mechanical safety
CAUTION
Personal injury due to contact with moving parts
The analyzer’s microwell plate loader moves during plate loading.
r Do not touch any parts of the analyzer other than those specified. Keep away from
moving parts during operation.
r Observe the system safety labels as illustrated in section Safety labels on the system
(p. 24)
Reagents and consumables
CAUTION
Skin inflammation or injury caused by reagents
Direct contact with reagents, detergents, or cleaning solutions may cause skin irritation,
inflammation, or burns.
r When handling reagents, exercise the precautions required for handling laboratory
reagents. Be sure to wear protective equipment (such as goggles, gloves).
r Observe the cautions given in the package insert and observe the information given in
the Material Safety Data Sheets available for Roche Diagnostics reagents and cleaning
solutions.
r If a reagent or detergent comes into contact with your skin, wash it off immediately
with soap and water, and apply a disinfectant. Consult a physician immediately.
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