Operators Manual
237 Pages
Preview
Page 1
cobas® 4800 system Operator’s Manual Software Version 1.0
cobas® 4800 system
Document information Revision history
Edition notice
Manual version
Software version
Revision date
1.0
1.0
July 2009
Changes
This manual is for users 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 Diagnostics Ltd reserves the right to make any changes necessary without notice as part of ongoing product development. Any customer modification to the instrument or analyzer will render the warranty or service agreement null and void. Software updates are done by Roche Service representatives.
Intended use
The cobas® 4800 system is intended to be used as a diagnostic or screening system providing sample preparation, amplification and detection of specific targets from human samples. Initial diagnostic targets are Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) and human papillomavirus (HPV). It is important that the operator read this manual thoroughly before using the system. The cobas® 4800 system is to be used by laboratory professionals trained in laboratory techniques and by instruction on the use of the system.
Copyright Trademarks
© 2009, Roche Diagnostics Ltd. All rights reserved. The following trademarks are acknowledged: COBAS and LIFE NEEDS ANSWERS are trademarks of Roche. All other trademarks are the property of their respective owners.
Roche Diagnostics 2
Operator’s Manual · Version 1.0
cobas® 4800 system
Instrument approvals
The cobas x 480 instrument and the cobas z 480 analyzer meet the protection requirements laid down in IVD Directive 98/79/EC. Furthermore, the cobas z 480 analyzer is manufactured and tested according to the following international standards: o
IEC 61010-1
o
IEC 61010-2-101
o
UL 61010-1
o
CAN/CSA C22.2 No. 61010-1
The Operator’s Manual meets the European Standard EN 591. Compliance is demonstrated by the following marks: Complies with the IVD directive 98/79/EC.
Issued by Underwriters Laboratories, Inc. (UL) for Canada and the US.
C
®
US
Contact addresses Roche Molecular Systems, Inc. 1080 U.S. Highway 202 Branchburg, NJ 08876-1760 USA Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim Germany
Roche Diagnostics Operator’s Manual · Version 1.0
3
cobas® 4800 system
Roche Diagnostics 4
Operator’s Manual · Version 1.0
cobas® 4800 system
Table of contents Document information Contact addresses Table of contents Preface How to use this manual Conventions used in this manual
System description
2 3 5 7 7 7
Maintenance 8
Maintenance
Safety information cobas x 480 instrument maintenance cobas z 480 analyzer maintenance
C–5 C–6 C–17
Part A Troubleshooting
1
Part C
Part D
General safety information
Safety classifications Safety precautions Safety summary Safety labels on the system Disposal of the cobas x 480 instrument and the cobas z 480 analyzer
A–5 A–6 A–8 A–16
9
Troubleshooting and messages
Overview Messages work area Troubleshooting Error messages
D–5 D–7 D–10 D–14
A–19 10 Result flags
2
Overview
System overview Run types, tests, and media types 3
Hardware
cobas x 480 instrument cobas z 480 analyzer Control unit 4
A–23 A–28
A–33 A–62 A–66
A–71 A–72 A–80
Part E
Glossary
E–3
Index
Revisions Operation 5
F–3
Part G
Part B
B–5 B–6 B–10 B–15
Operation
Safety information Performing a full run Performing a PCR Only run cobas® 4800 Work Order Editor Results 7
Part F
Workflow
Introduction Full run with LIS Full run without LIS PCR Only run 6
D–19 D–21
Glossary
Index
Software
Introduction Basic software elements Database
About result flags List of result flags
B–21 B–22 B–46 B–55 B–60
Configuration
Introduction Configuration User management
B–69 B–70 B–76
Roche Diagnostics Operator’s Manual · Version 1.0
5
cobas® 4800 system
Roche Diagnostics 6
Operator’s Manual · Version 1.0
cobas® 4800 system
Preface The cobas® 4800 system integrates fully automated total nucleic acid isolation directly from primary and secondary sample tubes, automated PCR setup, and real-time PCR. This manual covers the complete cobas® 4800 system comprised of the cobas® 4800 software, the cobas x 480 instrument used for sample preparation, and the cobas z 480 analyzer used for amplification and detection using real-time PCR.
How to use this manual o
Keep this Operator’s Manual in a safe place to ensure that it is not damaged and remains available for use.
o
This Operator’s 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.
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
a
Start of procedure End of procedure
o
List item
e
Cross-reference
h
Call-up (software reference) 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.
Roche Diagnostics Operator’s Manual · Version 1.0
7
cobas® 4800 system
Abbreviations
The following abbreviations are used: Abbreviation
Definition
A
ANSI
American National Standards Institute
C
cc
cubic centimeter
cLLD
Capacitive Liquid Level Detection
CT
Chlamydia Trachomatis
CSA
Canadian Standards Association
D
dBA
decibel weighted against the A-frequency response curve. This curve approximates the audible range of the human ear.
DIL
Diluent
DWP
Deepwell Plate
E
EC
European community
e.g.
exempli gratia – for example
EMC
ElectroMagnetic Compatibility
EN
European standard
H
HPV
Human Papillomavirus
I
i.e.
id est – that is to say
IEC
International Electrical Commission
iSWAP
internal Swivel Arm Plate handler
IVD
In Vitro Diagnostic
K
KVA
kilovolt-Ampere
L
LED
Light Emitting Diode
LIS
Laboratory Information System
M
MWP
MicroWell Plate
N
n/a
not applicable
NG
Neisseria Gonorrhoeae
P
PC
PreservCyt®
PCR
Polymerase Chain Reaction
Q
QC
Quality Control
S
SD
Standard Deviation
SP
SurePath ™
U Roche Diagnostics 8
Operator’s Manual · Version 1.0
cobas® 4800 system
Abbreviation
Definition
UL
Underwriters Laboratories Inc.
UT
UniTrans (cobas PCR Media)
UUT
Urine UniTrans (urine stabilized with cobas PCR Media)
W
WEEE
Waste Electrical and Electronic Equipment
X
XML
Extensible Markup Language
Roche Diagnostics Operator’s Manual · Version 1.0
9
cobas® 4800 system
Roche Diagnostics 10
Operator’s Manual · Version 1.0
System description
A
1
General safety information... A–3
2
Overview... A–21
3
Hardware... A–31
4
Software... A–69
cobas® 4800 system
1 General safety information Table of contents
General safety information
In this chapter, you will find information on the safe operation of the cobas® 4800 system.
In this chapter
Chapter
1
Safety classifications ... A–5 Safety precautions ... A–6 Operator qualification ... A–6 Safe and proper use of the instrument and analyzer ... 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–10 Explosion and fire risk ... A–10 Caution messages ... A–11 Mechanical safety ... A–11 Reagents ... A–12 Insoluble contaminants in samples ... A–12 Evaporation of samples or reagents ... A–12 Cross contamination ... A–13 Hot surfaces ... A–13 Data security ... A–14 Notices ... A–15 Moving parts ... A–15 Circuit breakers and fuses ... A–15 Spillage ... A–15 Safety labels on the system ... A–16 Safety labels on cobas x 480 instrument ... A–17 Safety labels on cobas z 480 analyzer ... A–18 Disposal of the cobas x 480 instrument and the cobas z 480 analyzer ... A–19
Roche Diagnostics Operator’s Manual · Version 1.0
A-3
1 General safety information
cobas® 4800 system
Table of contents
Roche Diagnostics A-4
Operator’s Manual · Version 1.0
cobas® 4800 system
1 General safety information 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: 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
Indicates a hazardous situation which, if not avoided, could result in death or serious injury. CAUTION
CAUTION
Indicates a hazardous situation which, if not avoided, could result in minor or moderate injury.
NOTICE
NOTICE Indicates a hazardous situation which, if not avoided, could result in damage to equipment. e For more information about the product safety labels, see Safety labels on the system on
page A-16
Important information which is not safety relevant is indicated by the following symbol: Tip Indicates additional information on correct use of the system or useful tips.
Roche Diagnostics Operator’s Manual · Version 1.0
A-5
cobas® 4800 system
1 General safety information Safety precautions
Safety precautions 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 the Operator’s Manual. o
Do not carry out operation and maintenance unless you have been trained by Roche Diagnostics.
o
Carefully follow the procedures specified in the Operator’s Manual for the operation and maintenance of the cobas x 480 instrument and the cobas z 480 analyzer.
o
Leave maintenance, installation, or service that is not described in the Operator’s Manual to trained Roche Service personnel.
o
Follow standard laboratory practices, especially when working with biohazardous material.
Safe and proper use of the instrument and analyzer Personal protective equipment
Accuracy/precision of measured results
Installation
Correct use
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.
o
Wear a face shield if there is a chance of splash or splatter.
o
Do not use reagents that have exceeded their expiration 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 instrument, analyzer, and reagent performance meets the published specifications.
o
Installation must be performed by trained Roche Service personnel only.
o
Leave installation that is not described in the Operator’s Manuals to trained Roche Service personnel.
Use the cobas x 480 instrument only for preparing liquid samples with the provided reagents.
Roche Diagnostics A-6
Operator’s Manual · Version 1.0
cobas® 4800 system
1 General safety information Safety precautions
Operating conditions
Approved parts
Third-party software
o
Operation outside of the specified ranges may lead to incorrect results or malfunction of the instrument or analyzer.
o
Use the instrument and analyzer as indicated in the technical specifications.
o
Make sure that the instrument’s and analyzer’s ventilation openings remain unobstructed at all times.
o
Perform maintenance according to the specified intervals to maintain the operating conditions of the instrument and analyzer.
o
Keep the Operator’s Manual in a safe place to ensure that it is not damaged and remains available for use. This manual must be easily accessible at all times.
Use of non-approved parts or devices may result in malfunction of the instrument or analyzer and may render the warranty null and void. Only use parts and devices approved by Roche Diagnostics. Installation of any third-party software that is not approved by Roche Diagnostics may result in incorrect behavior of the cobas® 4800 system or the cobas® 4800 software. Do not install any non-approved software.
Miscellaneous safety precautions Power interruption
A power failure or momentary drop in voltage may damage the instrument or analyzer or lead to data loss. Perform regular backups of measurement results. Operation with an uninterruptible power supply (UPS) is recommended.
Electromagnetic fields
Devices that emit electromagnetic waves may cause the instrument or analyzer to malfunction. Do not operate the following devices in the same room where the instrument or analyzer are installed:
Relocation and transportation
o
Mobile phone
o
Transceiver
o
Cordless phone
o
Other electrical devices that generate electromagnetic fields
Do not attempt to relocate or transport the instrument or analyzer. Leave relocation and transportation to personnel trained or authorized by Roche. e For additional details, see Disposal of the cobas x 480 instrument and the cobas z 480
analyzer on page A-19
Roche Diagnostics Operator’s Manual · Version 1.0
A-7
cobas® 4800 system
1 General safety information Safety summary
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 and Part Maintenance.
Warning messages List of warning messages WARNING
Before operating the system, read the warning messages contained in this summary carefully. Failure to observe them may result in death or serious injury.
Electrical safety Electrical shock by electronic equipment o
Do not attempt to work in any electronic compartment.
o
Do not remove any cover of the instrument or analyzer other than those specified in this Operator’s Manual.
o
Do not touch any parts of the instrument or analyzer 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
Observe the system safety labels as illustrated in section Safety labels on the system on page A-16.
Optical safety Loss of sight due to staring into laser beam The barcode scanner on the autoloader of the cobas x 480 instrument contains a class II laser diode. Do not stare into the laser transmitter beam as eyesight may be severely damaged.
Roche Diagnostics A-8
Operator’s Manual · Version 1.0
cobas® 4800 system
1 General safety information Safety summary
Biohazardous materials Infection by samples and associated materials Samples processed on the instrument and analyzer are provided in media that inactivate potentially biohazardous material. However, as with all human-derived specimens, universal precautions should be taken when handling and processing samples. 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
Keep the main cover closed and in place while the cobas x 480 instrument is operating.
o
When working with the main cover open while the cobas x 480 instrument is powered on (e.g., for cleaning or maintenance), always put the cobas x 480 instrument in Maintenance mode or in Shutdown status first.
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.
o
Wear a face shield if there is a chance of splash or splatter.
o
If any biohazardous material is spilled, wipe it up immediately and apply disinfectant.
o
If sample or waste solution comes into contact with your skin, wash it off immediately with soap and water and apply a disinfectant. Consult a physician.
Infection and injury due to sharp objects When wiping sharp objects, use several layers of gauze. o
Be careful to not puncture yourself.
o
Be sure to wear appropriate protective equipment, for example gloves.
Roche Diagnostics Operator’s Manual · Version 1.0
A-9
cobas® 4800 system
1 General safety information Safety summary
Waste Infection by biohazardous waste Liquid and solid waste originate 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 waste solution or used pipetting tips may result in infection. All materials and mechanical components associated with the waste systems are potentially biohazardous. 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 with water and apply a disinfectant. Consult immediately a physician.
o
Observe the system safety labels as illustrated in section Safety labels on the system on page A-16.
Contamination of the environment by liquid waste and solid waste The waste of the cobas x 480 instrument and the cobas z 480 analyzer is potentially biohazardous. o
When disposing of any liquid or solid waste generated by the cobas x 480 instrument or cobas z 480 analyzer, do so according to the appropriate local regulations.
e For information about disposal of the instrument and analyzer, see Disposal of the
cobas x 480 instrument and the cobas z 480 analyzer on page A-19
Explosion and fire risk Explosion through sparks Hazard of explosion through sparks. o
Keep all potentially flammable or explosive material (e.g. anesthetic gas) away from the instrument and analyzer.
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 and analyzer is connected to the main power supply, and do not use sprays in the vicinity of the instrument and analyzer.
o
During fire-fighting operations disconnect the instrument, analyzer, and the control unit from the main power supply.
Roche Diagnostics A-10
Operator’s Manual · Version 1.0
cobas® 4800 system
1 General safety information Safety summary
Caution messages List of caution messages CAUTION
Before operating the system, read the caution messages contained in this summary carefully. Failure to observe them may result in minor or moderate injury.
Mechanical safety Personal injury due to contact with moving parts The pipetting head of the cobas x 480 instrument moves rapidly during sample preparation. The main cover is locked during operation, protecting the user from moving parts. o
Keep the main cover closed and in place while the cobas x 480 instrument is operating.
o
When working with the main cover open while the cobas x 480 instrument is powered on (e.g., for cleaning or maintenance), always put the cobas x 480 instrument in Maintenance mode or in Shutdown status first.
o
Do not touch any parts of the cobas x 480 instrument other than those specified. Keep away from moving parts during cobas x 480 instrument operation.
o
During operation and maintenance of the cobas x 480 instrument, proceed according to the instructions.
o
Observe the system safety labels as illustrated in section Safety labels on the system on page A-16.
Roche Diagnostics Operator’s Manual · Version 1.0
A-11