Roche cobas x 480 User manual

Type
User manual

This manual is also suitable for

1
cobas
®
4800 System
User Assistance version 2.0
Software version 2.2
Roche Diagnostics
cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0
2
Publication information
Edition notice This publication is intended for operators of the
cobas x 480 instrument and/or the cobas z 480
analyzer.
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 User Assistance contains all information about the
product, including the following:
• Routine operation
• Maintenance
• Safety
• Troubleshooting information
• A software reference
• Configuration information
• Background information
The Safety chapter contains important safety
information. You must read the Safety chapter before
operating the system.
Publication
version
System software
version
Revision date Change description
1.0 2.2 May 2015 First version. New manual structure and design. Software
update from 2.1 to 2.2
2.0 2.2 April 2017 o Added RoHS directive 2011/65/EU to Approvals section.
o Compliance marks updated to include ‘CSA’ and
‘Laboratory Equipment’.
o Symbols used on product updated to include ‘Cont.’,
‘Content’ and ‘A/C only’.
o Transferred general safety messages to Safety chapter and
revised safety messages throughout manual.
o In chapter Introduction to the user interface, added About
the sample editor section and About the results work area
section.
o Revised cleaning procedure of the instrument.
o Updated images of thermal cycler door (analyzer) in
Exchanging fuses section.
o Added new Operation chapter with available workflows.
o Added information on new integrated heater/shaker unit.
o Revised description for sealing the microwell plate.
o Changed name of deliverable from cobas
®
4800 System
System Manual to cobas
®
4800 System User Assistance.
o Added new Safety chapter. Information of previous Safety
manual is now integrated in this manual as Safety chapter.
y Revision history
Roche Diagnostics
cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0
3
The test-specific Instructions for Use provides
additional information such as instructions on storage
and handling of reagents, samples, and controls. The
Instructions for Use also provides information on manual
PCR setup of the microwell plate.
Before using the system, it is important that the operator
reads these publications.
!
General attention
To avoid serious or fatal injury, ensure that you are
familiar with the instructions and safety information
before you use the instrument or analyzer.
r Pay particular attention to all safety precautions.
r Always follow the instructions in this publication.
r Do not use the instrument or analyzer in a way that is
not described in this publication.
r Store all publications in a safe and easily retrievable
place.
Privacy notice
When you use User Assistance on line, viewing events
(topics viewed and searches performed) and IP addresses
are logged.
The data collected is for Roche internal use only and is
never forwarded to third parties. It is anonymized, and
after one year it is automatically deleted.
Viewing events are analyzed to improve User Assistance
content and search functionality. IP addresses are used to
classify regional behavior.
You can configure how data is collected.
u Configuring User Assistance data collection (26)
Training Do not carry out operation tasks or maintenance 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.
Warranty Any customer modification to the system renders the
warranty or service agreement null and void.
Roche Diagnostics
cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0
4
For conditions of warranty, contact your local sales
representative or refer to your warranty contract partner.
Always leave software updates to a Roche Service
representative or perform such updates with their
assistance.
Copyright © 2009-2017 F. Hoffmann-La Roche Ltd. All rights
reserved.
License information
cobas
®
4800 software is protected by contract law,
copyright law, and international treaties. cobas
®
4800
software contains a user license between F. Hoffmann-La
Roche Ltd. and a license holder, and only authorized
users may access the software and use it. Unauthorized
use and distribution may result in civil and criminal
penalties.
Trademarks The following trademarks are acknowledged:
COBAS, COBAS X, 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 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 instrument and the analyzer meet the protection
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.
The analyzer is manufactured and tested according to the
following international standards:
• IEC 61010-1
• IEC 61010-2-101
• UL 61010-1
• CAN/CSA C22.2 No. 61010-1
Compliance with the applicable directive(s) is provided by
means of the Declaration of Conformity.
Roche Diagnostics
cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0
5
The following marks demonstrate compliance:
Contact addresses
Complies with the IVD directive 98/79/EC on in vitro
diagnostic medical devices.
For in vitro diagnostic use.
Issued by Underwriters Laboratories, Inc. (UL) for
Canada and the US.
Issued by CSA Group for Canada and the US.
'Laboratory Equipment' is the product identifier as
shown on the name plate.
CUS
cobas z 480 analyzer and cobas
®
4800 software
Roche Molecular Systems Inc.
1080 US Highway 202 South
Branchburg, NJ 08876
USA
Made in Switzerland
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
cobas x 480 instrument
HAMILTON Bonaduz AG
Via Crusch 8
CH-7402 Bonaduz
Switzerland
Made in Switzerland
Roche Diagnostics
cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0
6
Distributed in the United States by:
Roche Diagnostics
9115 Hague Road
Indianapolis
Indiana
USA
Roche Diagnostics
cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0
7
Roche Diagnostics
cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0
8
Table of contents 9
Roche Diagnostics
cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0
Table of contents
Publication information 2
Contact addresses 5
Table of contents 9
Preface 11
Intended use 12
Symbols and abbreviations 12
What is new in publication version 2.0 15
What is new in publication version 1.0 16
User Assistance
1 User Assistance
Using User Assistance 23
Safety
2 General safety information
Introduction 31
Safety classifications 32
Safety precautions 33
Warning messages 36
Caution messages 50
Notices 53
Safety labels on the system 55
Safety information for disposal 61
System description
3 Overview
System overview 67
4 Hardware
Instrument overview 77
Analyzer overview 98
Consumables overview 103
Control unit overview 108
About the hand-held barcode reader 109
Barcode configuration specifications 110
5 Introduction to the user interface
About the screen design 113
About the sample editor 123
About the results work area 130
About the database 145
About the audit trail 147
Operation
6 Operation
About workflows 153
Full workflow overview 155
Recovery workflow overview 190
PCR Only workflow overview 202
Configuration
7 Configuration
About configuration 225
About managing users 230
Exporting support data 238
About result counters 239
Maintenance
8 Maintenance
Instrument maintenance 245
Analyzer maintenance 276
Troubleshooting
9 Troubleshooting
Troubleshooting information in the user
interface 293
About the messages work area 295
Reviewing and confirming new alarms 297
Deleting alarms and messages 298
Troubleshooting software 299
Troubleshooting hardware 302
List of error messages and system flags
10 Error messages and system flags
Error messages 315
List of error messages 316
System flags 350
List of system flags 351
Glossary
11 Glossary
Index
Index 363
10 Table of contents
Roche Diagnostics
cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0
Roche Diagnostics
cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0
11
Preface
The system integrates fully automated total nucleic acid
isolation directly from primary and secondary tubes,
automated PCR setup, and real time PCR.
This manual covers the complete system:
• cobas
®
4800 software
• cobas x 480 instrument used for sample preparation
• cobas z 480 analyzer used for amplification and
detection using real time PCR
Roche Diagnostics
cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0
12
Intended use
System
(instrument and analyzer)
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. It integrates fully automated
total nucleic acid isolation directly from primary and
secondary tubes, automated PCR setup, and real time
PCR.
Analyzer The cobas z 480 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 cobas x 480 instrument and cobas z 480 analyzer
are to be used by laboratory professionals trained in
laboratory techniques and by instruction on the use of the
system and analyzer.
Symbols and abbreviations
Product names Except where the context clearly indicates otherwise, the
following product names and abbreviations are used:
Product name Descriptor
cobas
®
4800 software
software
cobas x 480 instrument instrument
cobas z 480 analyzer analyzer
cobas
®
4800 System
system
cobas
®
4800 System Sample
Preparation Kit
sample preparation kit
Extraction plate 1.6ml deepwell plate
Extraction plate 2.0ml deepwell plate
AD-plate 0.3ml microwell plate
Reagent reservoir 50ml 50 mL reagent reservoir
Reagent reservoir 200ml 200 mL reagent reservoir
Core Tips with Filter 1ml pipette tip
PreservCyt
®
carrier
collection medium carrier
(test-specific)
y Product names
Roche Diagnostics
cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0
13
Symbols used in the publication
Symbols used on product
Symbol Explanation
o List item
u Related topics containing further information.
q Tip. Extra information on correct use or useful
hints.
r Start of a task
I Extra information within a task
f Result of a user action within a task
c Frequency of a task
n Duration of a task
d Materials that are required for a task
j Prerequisites of a task
u Topic. Used in cross-references to topics.
p Task. Used in cross-references to tasks.
w Figure. Used in figure titles and cross-
references to figures.
y Table. Used in table titles and cross-references
to tables.
z Equation. Used in cross-references to
equations.
k Code example. Used in code titles and cross-
references to codes.
Print. Used for printable documents.
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.
y Symbols used in the publication
Symbol Explanation
Global Trade Item Number.
y Symbols used on product
Roche Diagnostics
cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0
14
Abbreviations The following abbreviations are used:
Quantity contained in the package.
Quantity contained in the package.
Indicates that the equipment is suitable for
alternating current only; to identify relevant
terminals.
Symbol Explanation
y Symbols used on product
Abbreviation Definition
AD Amplification and detection
ANSI American National Standards Institute
cc Cubic centimeter
cLLD Capacitive liquid level detection
CSA Canadian Standards Association
dBA Decibel weighted against the A-frequency
response curve. This curve approximates
the audible range of the human ear.
DWP Deepwell plate
EC European Community
e.g. Exempli gratia – for example
EN European standard
i.e. Id est – that is to say
IEC International Electrical Commission
iSWAP Internal Swivel Arm Plate handler
IVD In-vitro diagnostic
LED Light emitting diode
LIS Laboratory information system
MWP Microwell plate
n/a Not applicable
PCR Polymerase chain reaction
UL Underwriters Laboratories Inc.
UPS Uninterruptible power supply
WEEE Waste Electrical and Electronic Equipment
XML Extensible Markup Language
y Abbreviations
Roche Diagnostics
cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0
15
What is new in publication version 2.0
Short description of all major changes in this version.
User Assistance chapter Added new chapter on using the User Assistance.
u Using User Assistance (23)
Safety information chapter Added new general safety information chapter.
u Safety classifications (32)
Integrated heater/shaker unit Added information on new integrated heater/shaker unit
in the instrument.
u Heater/shaker unit (94)
Sample editor section Added section on sample editor for handling work order
files.
u About the sample editor (123)
Results work area section Added section on the results work area.
u About the results work area (130)
New Operation chapter Added new Operation chapter with possible workflows
for performing a run.
u About workflows (153)
Cleaning procedure The cleaning solution for the instrument has been revised.
u About cleaning the instrument (247)
New decontamination section Added new section on instrument decontamination.
u Decontamination (264)
Thermal cycler door The thermal cycler door of the analyzer has been
modified. The door is now fitted with a metal hinge
covering the secondary fuses. To replace a secondary
fuse, you must now open the thermal cycler door.
u To exchange a secondary fuse (285)
Error messages and flags chapter Added new chapter on error messages and system flags.
u Error messages (315)
u System flags (350)
Roche Diagnostics
cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0
16
What is new in publication version 1.0
Short description of all major changes in publication
version 1.0.
Solid waste door New hardware. The solid waste door allows you to access
and replace the small solid waste bag or waste chute
easily.
u About the waste station setup (84)
Enhancement to pipette tip pickup To minimize generating multiple partial tip racks after a
run, the system uses pipette tips from partial tip racks
before pipette tips from full tip racks.
u About the pipette tips (104)
Supported character formats for barcodes / is a supported barcode character.
u Barcode configuration specifications (110)
Sorting results function Results can be sorted by quantity.
u About sorting by column (117)
Result filter by sample Filtering options for controls. You can now filter results
based on sample types.
u Creating result filters (141)
Sorting of reports The laboratory manager can configure how the results
are sorted in the PDF results report.
u Reporting overview (226)
Button name The Extract support data button is renamed to Export
support data button.
u Exporting support data (238)
Weekly maintenance Additional alignment check during weekly maintenance
to ensure that instrument is within alignment
(approximately 7 extra minutes for weekly maintenance).
u Weekly maintenance (259)
Roche Diagnostics
cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0
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Roche Diagnostics
cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0
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Roche Diagnostics
cobas® 4800 System · Software version 2.2 · User Assistance · version 2.0
User Assistance
1 User Assistance ...................................................................................................... 21
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Roche cobas x 480 User manual

Type
User manual
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