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Roche cobas 8800, cobas 6800 User guide

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cobas
®
6800/8800 Systems
User Guide
Publication version 5.0
Software version 1.4
2
Roche Diagnostics
cobas
®
6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0
Publication information
Publication version Software version Revision date Change description
1.0 1.0 August 2014 First version
1.1 1.0 August 2014 Added videos and utility films to the User
Assistance.
1.2 1.0 October 2014 Added information on how to create reports,
implemented information related to findings
from usability tests, changed procedure on
how to empty solid waste.
2.0 1.1 July 2015 Section About the interval of the automatic
delete archived data maintenance action
removed.
Section Defining the interval to delete
archived data added.
Section About the automatic IG server
cleanup removed.
Section Defining automatic IG server
cleanup added.
2.1 1.1.10 January 2016 Publication title Operator’s Manual changed
to User Guide.
Section Cleaning up the instrument during
startup updated.
Section Canceling a run updated.
3.0 1.2 September 2016 Added new section about the minimum
volumes for gel separator tubes.
Updated the list of supported sample tubes
and the procedure to replace the liquid
waste container.
3.1 1.2 August 2017 Intended use updated. New instrument
approval. New radio equipment
specifications.
Update about repeat test.
Updated maintenance tasks to clean
processing module from front and to clean
covers. New maintenance task to
decontaminate rack trays.
3.2 1.2 July 2018 Details about cleaning solutions updated.
Message codes 1061 and 1072 updated.
Unloading amplification plate updated.
Consumable reuse information updated.
Information about loading sample tubes
with swabs added. Update about repeat
testing. Weekly system restart
recommendation added. Decontamination
procedures updated.
y Revision history
3
Roche Diagnostics
cobas
®
6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0
Publication version Software version Revision date Change description
4.0 1.3 October 2017 Added new tasks from the global
information area, a task to restart after a
shutdown longer than 3 months,
information about non-Roche external
controls and history calculation, new
maintenance task to clean the tube rotator,
and minor text and image updates.
u What is new in publication version 4.0
(19)
4.1 1.3 March 2018 Additional information related to tubes with
swabs and to non-Roche external controls
based on alcohol.
u What is new in publication version 4.1
(19)
4.2 1.3 August 2018 Using the User Assistance on the
instrument software updated. Environmental
conditions updated. Details about cleaning
solutions updated. Message codes 0305,
1061 and 1072 updated. Unloading
amplification plate updated. Consumable
reuse information updated. Update of the
list of flags. Update about repeat testing.
Weekly system restart recommendation
added. Decontamination procedures
updated.
u What is new in publication version 4.2
(16)
5.0 1.4 December 2019
u What is new in publication version 5.0
(13)
y Revision history
Edition notice
This publication is intended for users of the
cobas
®
6800/8800 Systems.
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 information
• Troubleshooting information
• Configuration information
• Background information
4
Roche Diagnostics
cobas
®
6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0
The Safety Guide contains important safety information.
This information is also included in the User Assistance.
You must read the Safety Guide before operating the
instrument.
The User Guide focuses on routine operation and
maintenance. The chapters are organized according to
the normal operation workflow. This information is also
included in the User Assistance.
General attention
To avoid serious or fatal injury, ensure that you are
familiar with the instructions and safety information
before you use the system.
r Pay particular attention to all safety precautions.
r Always follow the instructions in this publication.
r Do not use the system in a way that is not described
in this publication.
r Store all publications in a safe and easily retrievable
place.
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 will render the
warranty or service agreement null and void.
For conditions of warranty, please contact your local
sales representative or refer to your warranty contract
partner.
Software updates must be performed by or with the
assistance of a Roche Service representative.
Copyright
© 2014–2020, F. Hoffmann-La Roche Ltd. All rights
reserved.
5
Roche Diagnostics
cobas
®
6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0
License information
cobas
®
6800/8800 Systems software is protected by
contract law, copyright law, and international treaties.
cobas
®
6800/8800 Systems 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.
Open-source and commercial software
cobas
®
6800/8800 Systems may include components or
modules of commercial or open-source software. For
further information on the intellectual property and other
warnings, as well as licenses pertaining to the software
programs included in cobas
®
6800/8800 Systems, refer
to the electronic distribution included with this product.
This open-source and commercial software and
cobas
®
6800/8800 Systems as a whole can constitute a
device regulated in accordance with applicable law. For
more detailed information, refer to the User Guide and
labeling.
Note that the respective authorization is no longer valid
according to the corresponding legislation should any
unauthorized changes be made to cobas
®
6800/8800
Systems.
Trademarks
The following trademarks are acknowledged:
COBAS, COBAS OMNI, COBAS P, 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.
Instrument approvals
The cobas
®
6800/8800 Systems meet 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.
6
Roche Diagnostics
cobas
®
6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0
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.
Directive 2014/53/EU of the European Parliament and of
the Council of 16 April 2014 on the harmonization of the
laws of the Member States relating to the making
available on the market of radio equipment and repealing
Directive 1999/5/EC.
To view the full text of the 2014/53/EU declaration of
conformity, go to the Roche DiaLog Global Web Site
(https://dialog.roche.com/) and choose the eLabDoc
link.
If you are unable to access Roche DiaLog, contact a
Roche Service representative.
Compliance with the applicable directive(s) is provided
by means of the Declaration of Conformity.
The following marks demonstrate compliance:
Complies with the provisions of the applicable EU
directives.
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 type plate.
Contact addresses
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Switzerland
7
Roche Diagnostics
cobas
®
6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0
Distributed in the United States by
Roche Diagnostics
9115 Hague Road
Indianapolis
Indiana, USA
8
Roche Diagnostics
cobas
®
6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0
9Table of contents
Roche Diagnostics
cobas
®
6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0
Table of contents
Publication information 2
Contact addresses 6
Intended use 11
Symbols and abbreviations 11
What is new in publication version 5.0 13
What is new in publication version 4.2 16
What is new in publication version 4.1 19
What is new in publication version 4.0 19
Operation
1 Overview of the system
About the cobas
®
6800/8800 Systems
25
Monitor 27
Start button 28
Open/close covers button 29
Middle and rear covers 30
Overview of the sample supply module 31
Overview of the transfer module 35
Overview of the processing module 41
Overview of the analytic module 49
Buttons and power switches on the system 52
2 Overview of operation
Overview of the software 59
Overview of the main workflow 73
Quick start guide 76
3 Before operation
Starting up the system 83
System alarm concept 95
4 Reagents and consumables
Overview of the reagents and consumables 109
Unloading the amplification plates 110
Handling the wash/waste drawer 112
Loading the bulk reagent drawer 131
Unloading and loading the consumables
drawer
136
Loading and unloading the reagent cassette
drawer
143
5 Sample processing
Setting the system to Ready status 155
Handling test orders 156
Overview of loading/unloading procedures 160
Handling racks for clotted tips 166
Loading samples 172
Unloading sample racks 181
Starting a run 186
Canceling a run 189
Masking/unmasking a module or magazine 190
Reviewing test results 192
Test result reports 214
Releasing test results 219
Releasing test results via remote access 220
Downloading files from the IG server 221
Viewing audit trail entries 222
Exporting test results 223
Priming the instrument 224
6 After operation
Pausing and resuming the system 227
Setting the system to Hibernate status 228
Shutting down the system 230
Restarting by power switch 233
Shutting down the IG server 235
Starting the IG server 236
Setting the system to powerless status 237
Shut down for more than 10 days 240
Maintenance
7 Maintenance
List of maintenance intervals 245
Viewing maintenance logs 247
Periodic maintenance 248
Regular maintenance 281
Automatic maintenance actions 286
Decontamination 293
Moving the movable platform 304
System description
8 Specifications
List of system specifications 313
Supported material 316
Glossary
Index
10
Roche Diagnostics
cobas
®
6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0
11
Roche Diagnostics
cobas
®
6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0
Intended use
The cobas
®
6800/8800 Systems support an automated
and integrated workflow to run Polymerase Chain
Reaction (PCR) based Nucleic Acid Testing (NAT).
Thecobas
®
6800/8800 Systems combine the
functionalities of instrumentation, consumables,
reagents, and data management to provide an efficient
workflow from sample processing to result interpretation.
Symbols and abbreviations
Product names
Except where the context clearly indicates otherwise, the
following product names and descriptors are used.
Product name Descriptor
cobas
®
6800 System
system
cobas
®
6800/8800 Systems
system
cobas
®
6800/8800 Systems
software
software
cobas
®
8800 System
system
cobasomni Amplification Plate
amplification plate
cobasomni Liquid Waste
Container
liquid waste container
cobasomni Lysis Reagent
lysis reagent
cobasomni MGP Reagent
MGP reagent
cobasomni Pipette Tips
tip rack
cobasomni Processing Plate
processing plate
cobasomni Solid Waste
Container
solid waste container
cobasomni Specimen Diluent
diluent
cobasomni Wash Reagent
wash reagent
y Product names and abbreviation
Symbols used in the publication
The following symbols are used:
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.
y Symbols used in the publication
12
Roche Diagnostics
cobas
®
6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0
Symbol Explanation
I
Extra information within a task.
f
Result of an 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.
Context search. Used on the context search
tab.
Search. Used on the search tab.
Table of contents. Used on the table of
contents tab.
Hardware explorer. Used on the hardware
explorer tab.
History. Used on the history tab to show
previously viewed topics.
Favorites. Used on the favorites tab and on the
content panel.
Enlarge. Button used on images.
y Symbols used in the publication
Symbols used on the product
Symbol Explanation
Global Trade Item Number
Quantity contained in the package.
y Symbols used on the product
13
Roche Diagnostics
cobas
®
6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0
Symbol Explanation
Hardware coding of the cobasomni
Amplification Plate
Hardware coding of the cobasomni
Pipette Tips
Hardware coding of the cobasomni
Processing Plate
y Symbols used on the product
Abbreviations
The following abbreviations are used:
Abbreviation Definition
ANSI American National Standards Institute
CFR Code of Federal Regulations
CISPR Comité International Spécial des
Pertubations Radioélectriques
CSA Canadian Standards Association
EC European Community
EN European standard
FCC Federal Communications Commission
IEC International Electrical Commission
ISO International Organization for
Standardization
LIS Laboratory information system
MGP Magnetic glass particles
n/a not applicable
NAT Nucleic acid testing
PCR Polymerase chain reaction
RFID Radio frequency identification
SOP Standard Operating Procedure
UL Underwriters Laboratories Inc.
UPS Uninterruptible power supply
WEEE Waste Electrical and Electronic Equipment
y Abbreviations
What is new in publication version 5.0
Maintenance
Maintenance functions for the instruments and IG server
have been redesigned. The main changes are:
14
Roche Diagnostics
cobas
®
6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0
• Each instrument has its own maintenance settings.
Maintenance actions can be performed individually
for each instrument from the Monitoring tab.
• Scheduled instrument maintenance is performed
during the daily maintenance window. For each
instrument, you can define an individual daily
maintenance window.
• The maintenance actions are scheduled based on
their schedule plan (Daily, Weekly, and On
demand)
• To add more flexibility to the periodic maintenance
execution, you can define a lead period and grace
period for each maintenance action.
• The launch type defines whether the maintenance
action is launched automatically or has to be started
manually when due.
• Each maintenance action has default values.
• Instrument maintenance settings are configured in
Administration > Settings > Processing settings
> Instrument maintenance settings.
• IG server maintenance actions are configured in
Administration > Settings > Processing settings
> IG server maintenance settings.
• A new instrument maintenance action Sample
pipetters teaching was introduced.
u Refer to the section List of data management maintenance
actions in the User Assistance
u Refer to the section Instrument maintenance settings in
the User Assistance
u Starting the Sample pipetters teaching maintenance
action manually (291)
User Assistance
The description of the User Assistance was reworked.
u Refer to the section Using User Assistance in the User
Assistance
Message confirmation
It is possible to select and confirm several messages in
one step.
u Monitoring statuses and messages (97)
Solid waste compartment
The solid waste compartment and solid waste bag with
insert is now the default waste option. The solid waste
container for waste bags without an insert is available
only on request.
u About the options for solid waste (112)
15
Roche Diagnostics
cobas
®
6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0
Reagent cassette allocation
A new section about reagent cassette allocation was
added.
u Reagent cassette allocation (150)
Handling error sample racks on sample
supply module
Configuration of the error sample rack unloading settings
can be assigned for either unidirectional or bidirectional
modes in the sample supply module.
u About the unidirectional mode (162)
u About the bidirectional mode (164)
u Refer to the section Defining conveyor settings in the User
Assistance
Handling racks for clotted tips on sample
supply module
The racks for clotted tips are unloaded to the output
buffer when the sample supply module is set to
bidirectional mode and connected to a conveyor belt.
u Handling racks for clotted tips (166)
High-target test results
Results of high-target tests are displayed in a separate
High-target test results view.
u Reviewing test results (193)
Results detail panel
The results detail panel was changed. Results and flags
are displayed on separate tabs.
u Reviewing test results (193)
Cleaning processing modules
The cleaning procedure for the processing modules was
expanded with additional steps to clean the teach block
and the wash station, if necessary.
u Cleaning transfer and processing modules (7 of 8)
(273)
Barcode masking for secondary tubes
Barcode masking is not supported for secondary tubes
that are used for pooling.
u Refer to the section About barcode masking in the User
Assistance
Result upload to LIS
Results can be automatically uploaded to the LIS. The
result upload is configurable.
u Refer to the section Defining the connection to the LIS in
the User Assistance
16
Roche Diagnostics
cobas
®
6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0
Test order settings
Two new test order settings have been added.
• Repeat test button: The Repeat test button can be
disabled.
• Delete test orders for unprocessed samples after
system stopping.: Unprocessed test orders are
deleted during sample unloading.
u Refer to the section Defining test order settings in the
User Assistance
Screen sharing on IG server
Screen sharing on the IG server is done using the IG
server remote service access option.
u Refer to the section To enable and disable screen sharing
in the IG server in the User Assistance
Troubleshooting
The following new troubleshooting topics have been
added:
u Refer to the section Recovering the instrument after error -
including pre- and postactions in the User Assistance
u Refer to the section Guided troubleshooting for pipetting
issues on the transfer module in the User Assistance
u Refer to the section Finding pipetting issues in the
message list in the User Assistance
u Refer to the section Finding unprocessed samples in the
message list in the User Assistance
What is new in publication version 4.2
Using the User Assistance on the instrument
software
The User Assistance is accessible from the instrument
software.
Environmental conditions
Environmental conditions (ambient temperature and
humidity) have been updated.
u Environmental conditions (313)
List of supported sample tubes
Contact details were added where to get information
about validated tubes and tubes that are not supported
by the system.
u List of supported sample tubes (316)
17
Roche Diagnostics
cobas
®
6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0
List of allowed cleaning solutions
Further details about the use of neodisher MediClean
®
were added.
u List of allowed cleaning solutions (318)
Pausing and resuming the system
Information about pausing and resuming the system was
updated.
u Starting the system from Paused status (85)
u List of system statuses (103)
u Pausing and resuming the system (227)
List of sample supply module message codes
Measure for the message codes 0305, 1061, and 1072
was updated.
u List of sample supply module message codes (101)
Unloading the amplification plates
Information about unloading the amplification plates was
updated.
u Unloading the amplification plates (110)
Consumable reuse
Information about the consumable reuse was updated.
Manually removed consumables that were already used
must be discarded. Never reload used consumables.
An additional warning statement about the risk of
contamination was added.
u Unloading and loading the consumables drawer (136)
u Loading tip racks, reagent, and control cassettes (143)
u Refer to the section Recovering the instrument after error
in the User Assistance
u Refer to the section Cleaning up the transfer module in the
User Assistance
u Refer to the section Cleaning up the processing module in
the User Assistance
Loading samples
Preconditions for sample loading were updated. Ensure
that all sample tubes are decapped when loading
samples.
u Loading samples (173)
List of flags
Flag details were added to the list of flags.
u List of flags (196)
18
Roche Diagnostics
cobas
®
6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0
Ordering a repeat test
Information about ordering a repeat test was updated.
u Ordering a repeat test (209)
System shutdown and restart
A recommendation to weekly shut down and restart the
system was added.
u Shutting down the system (230)
u Periodic maintenance action (245)
Maintenance actions
Precondition to start maintenance actions was updated
for two maintenance actions. The instrument must be in
Standby status to start a maintenance action.
u Starting the periodic maintenance wizard to open the
covers (6 of 8) (272)
u Starting the Sample pipetter tightness check
maintenance action manually (289)
Automatic maintenance actions
Introduction to the automatic maintenance action was
updated. Information about the responsible user for
automatic maintenance actions was added.
u Automatic maintenance actions (286)
Decontamination procedures
Procedures to decontaminate solid and liquid waste
containers were updated.
u Decontaminating solid and liquid waste containers
(302)
Barcode types EAN-8 and EAN-13
Information about the use of barcode types EAN-8 and
EAN-13 was updated. Barcodes starting with prefix 378
and 379 are not supported.
u Refer to the section About barcodes in the User
Assistance
New option for LIS connection
Information about the new Include rack ID and rack
position of loaded samples option was added.
u Refer to the section Defining the connection to the LIS in
the User Assistance
Unloading consumables drawer in powerless
or Error status
Information to discard the reagent cassettes after
removal from the interim reagent storage was added.
u Refer to the section Unloading consumables drawer and
MGP cassettes in the User Assistance
19
Roche Diagnostics
cobas
®
6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0
What is new in publication version 4.1
Non-Roche controls based on alcohol
New safety information about loading non-Roche
controls based on alcohol.
Sample tubes with swabs
Additional information added about loading sample
tubes with swabs.
u To load samples (173)
What is new in publication version 4.0
New tasks from the global information area
New tasks to configure language and other settings, to
lock the system, and to restart the user interface.
u Editing personal settings (62)
u Locking the system (63)
u Restarting the user interface (64)
Restarting after long shutdowns
Additional task for systems that have been shut down for
more than 3 months and update of task to restart the
system after a shutdown longer than 10 days.
u Restarting after a shutdown longer than 10days
(91)
u Restarting after a shutdown longer than 3months
(92)
Non-Roche controls
Result formatting of non-Roche controls.
u About test result formatting (192)
Cleaning the tube rotator
New maintenance task to clean the tube rotator and
improve barcode reading.
u Cleaning the tube rotator (283)
New LIS connection options
Task to configure LIS connection updated.
u Refer to the section Defining the connection to the LIS in
the User Assistance
Troubleshooting after dispense clot
Task to follow in case of having the system stopped after
dispense clot.
20
Roche Diagnostics
cobas
®
6800/8800 Systems · Software version 1.4 · User Guide · Publication version 5.0
u Refer to the section Recovering the system after detecting
a clot during dispensing in the User Assistance
/