cobas 5800

Roche cobas 5800, cobas 6800, cobas 8800 User guide

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cobas
®
6800/8800 Systems
User Guide
Publication version 4.2
Software version 1.3
Roche Diagnostics
cobas® 6800/8800 Systems · Software version 1.3 · User Guide · Publication version 4.2
2
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.
u What is new in publication version
3.0 (19)
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.
u What is new in publication version
3.1 (18)
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.
u What is new in publication version
3.2 (16)
y Revision history
Roche Diagnostics
cobas® 6800/8800 Systems · Software version 1.3 · User Guide · Publication version 4.2
3
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
• Troubleshooting information
• Configuration information
• Background information
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 (15)
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 (15)
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 (13)
Publication version Software version Revision date Change description
y Revision history
Roche Diagnostics
cobas® 6800/8800 Systems · Software version 1.3 · User Guide · Publication version 4.2
4
The Safety Guide contains important safety information.
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.
!
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 © 2014–2018, F. Hoffmann-La Roche Ltd. All rights
reserved.
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.
Roche Diagnostics
cobas® 6800/8800 Systems · Software version 1.3 · User Guide · Publication version 4.2
5
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.
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.
Roche Diagnostics
cobas® 6800/8800 Systems · Software version 1.3 · User Guide · Publication version 4.2
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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://dialog1.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:
Contact addresses
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.
CUS
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Switzerland
Roche Diagnostics
cobas® 6800/8800 Systems · Software version 1.3 · User Guide · Publication version 4.2
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Distributed in the United States by
Roche Diagnostics
9115 Hague Road
Indianapolis
Indiana, USA
Roche Diagnostics
cobas® 6800/8800 Systems · Software version 1.3 · User Guide · Publication version 4.2
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Table of contents 9
Roche Diagnostics
cobas® 6800/8800 Systems · Software version 1.3 · User Guide · Publication version 4.2
Table of contents
Publication information 2
Contact addresses 6
Table of contents 9
Intended use 11
Symbols and abbreviations 11
What is new in publication version 4.2 13
What is new in publication version 4.1 15
What is new in publication version 4.0 15
What is new in publication version 3.2 16
What is new in publication version 3.1 18
What is new in publication version 3.0 19
What is new in publication version 2.1 20
What is new in publication version 2.0 22
What is new in publication version 1.2 23
Operation
1 Overview of the system
About the cobas
®
6800/8800 Systems 29
Overview of the sample supply module 32
Overview of the transfer module 35
Overview of the processing module 37
Overview of the analytic module 40
Buttons and power switches on the system 41
2 Overview of operation
Overview of the software 47
Overview of the main workflow 63
Quick start guide 66
3 Before operation
Starting up the system 71
System alarm concept 84
4 Reagents and consumables
Overview of the reagents and consumables 97
Unloading the amplification plates 98
Handling the wash/waste drawer 100
Loading the bulk reagent drawer 119
Loading the consumables drawer 124
Loading and unloading the reagent cassette
drawer 131
5 Sample processing
Setting the system to Ready status 141
Handling test orders 142
Overview of loading/unloading procedures 146
Handling racks for clotted tips 151
Loading samples 156
Unloading sample racks 165
Starting a run 170
Canceling a run 173
Masking/unmasking a module or magazine 174
Reviewing test results 176
Test result reports 197
Releasing test results 203
Releasing test results via remote
connection 204
Downloading files from the IG server 205
Viewing audit trail entries 206
Exporting test results 207
Priming the instrument 208
6 After operation
Pausing and resuming the system 211
Setting the system to Hibernate status 212
Shutting down the system 214
Restarting by power switch 217
Shutting down the IG server 219
Starting the IG server 220
Setting the system to powerless status 221
Shut down for more than 10 days 224
7 Maintenance
List of maintenance intervals 227
Periodic maintenance 228
Regular maintenance 259
Automatic maintenance actions 264
Decontamination 269
Moving the movable platform 280
Appendix
8 Specifications
List of system specifications 289
Supported material 292
9 Glossary
Index 299
10 Table of contents
Roche Diagnostics
cobas® 6800/8800 Systems · Software version 1.3 · User Guide · Publication version 4.2
Roche Diagnostics
cobas® 6800/8800 Systems · Software version 1.3 · User Guide · Publication version 4.2
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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.
Symbols used in the publication The following symbols 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
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 an action within a task.
c Frequency of a task.
n Duration of a task.
y Symbols used in the publication
Roche Diagnostics
cobas® 6800/8800 Systems · Software version 1.3 · User Guide · Publication version 4.2
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Symbols used on the product
Abbreviations The following abbreviations are used:
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.
Symbol Explanation
y Symbols used in the publication
Symbol Explanation
Global Trade Item Number
Quantity contained in the package.
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
Abbreviation Definition
AD Amplification and detection
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
y Abbreviations
Roche Diagnostics
cobas® 6800/8800 Systems · Software version 1.3 · User Guide · Publication version 4.2
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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.
u Refer to the section Using the User Assistance on the
instrument software in the User Assistance
u Refer to the section Displaying the User Assistance
within the work area in the User Assistance
Environmental conditions Environmental conditions (ambient temperature and
humidity) have been updated.
u Environmental conditions (289)
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 (292)
List of allowed cleaning solutions
Further details about the use of neodisher MediClean
®
were added.
u List of allowed cleaning solutions (295)
Pausing and resuming the system Information about pausing and resuming the system was
updated.
u Starting the system from Paused status (73)
u List of system statuses (92)
u Pausing and resuming the system (211)
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
SOP Standard Operating Procedure
UL Underwriters Laboratories Inc.
UPS Uninterruptible power supply
WEEE Waste Electrical and Electronic Equipment
Abbreviation Definition
y Abbreviations
Roche Diagnostics
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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 (89)
Unloading the amplification plates Information about unloading the amplification plates was
updated.
u Unloading the amplification plates (98)
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/loading the consumables drawer (124)
u Loading tip racks, reagent, and control cassettes (131)
u Refer to the section Cleaning up the instrument during
startup 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 (157)
List of flags Flag details were added to the list of flags.
u List of flags (182)
Ordering a repeat test Information about ordering a repeat test was updated.
u Ordering a repeat test (192)
System shutdown and restart A recommendation to weekly shut down and restart the
system was added.
u Shutting down the system (214)
u Periodic maintenance action (227)
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) (249)
u Starting sample pipetter tightness check
manually (266)
Roche Diagnostics
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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 (264)
Decontamination procedures Procedures to decontaminate solid and liquid waste
containers were updated.
u Decontaminating solid and liquid waste
containers (278)
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
What is new in publication version 4.1
Non-Roche external controls based on
alcohol
New safety information about loading non-Roche
external controls based on alcohol.
u Supported sample types (157)
Sample tubes with swabs Additional information added about loading sample tubes
with swabs.
u To load samples (157)
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 (50)
u Locking the system (51)
u Restarting the user interface (51)
Roche Diagnostics
cobas® 6800/8800 Systems · Software version 1.3 · User Guide · Publication version 4.2
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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 (79)
u Restarting after a shutdown longer than 3 months (82)
Non-Roche external controls Result formatting of non-Roche external controls.
u Refer to the section About test result formatting in the
User Assistance
Cleaning the tube rotator New maintenance task to clean the tube rotator and
improve barcode reading.
u Cleaning the tube rotator (261)
What is new in publication version 3.2
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 (292)
List of allowed cleaning solutions
Further details about the use of neodisher MediClean
®
were added.
u List of allowed cleaning solutions (295)
Pausing and resuming the system Information about pausing and resuming the system was
updated.
u Starting the system from Paused status (73)
u List of system statuses (92)
u Pausing and resuming the system (211)
List of sample supply module message codes Measure for the message codes 1061 and 1072 was
updated.
u List of sample supply module message codes (89)
Unloading the amplification plates Information about unloading the amplification plates was
updated.
u Unloading the amplification plates (98)
Roche Diagnostics
cobas® 6800/8800 Systems · Software version 1.3 · User Guide · Publication version 4.2
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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/loading the consumables drawer (124)
u Loading tip racks, reagent, and control cassettes (131)
u Refer to the section Cleaning up the instrument during
startup 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 (157)
Sample tubes with swabs Additional information about loading sample tubes with
swabs was added.
u Loading samples (157)
Ordering a repeat test Information about ordering a repeat test was updated.
u Ordering a repeat test (192)
System shutdown and restart A recommendation to weekly shut down and restart the
system was added.
u Shutting down the system (214)
u Periodic maintenance action (227)
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) (249)
u Starting sample pipetter tightness check
manually (266)
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 (264)
Roche Diagnostics
cobas® 6800/8800 Systems · Software version 1.3 · User Guide · Publication version 4.2
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Decontamination procedures Procedures to decontaminate sample racks and solid and
liquid waste containers were updated.
u Decontaminating sample racks (276)
u Decontaminating solid and liquid waste
containers (278)
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 tube
position of loaded samples in host query 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
Recovering the system after detecting a
dispense clot
A new troubleshooting procedure about recovering the
system after detecting a dispense clot was added.
u Refer to the section Recovering the system after
detecting dispense clot in the User Assistance
What is new in publication version 3.1
Intended use The intended use statement was updated.
u Intended use (11)
Additional directive New directive added to instrument approvals.
u Instrument approvals (5)
Radio equipment specifications Specifications for radio equipment were added.
u Radio equipment specifications (291)
Repeat test Tip added how to retest invalid individual sample. Further
reason added why no repeat test is possible. Information
added about repeat test with history calculation.
u Reviewing test results (176)
u Repeat test with history calculation (192)
Roche Diagnostics
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General decontamination procedure The general decontamination procedure was updated to
include lint-free cotton swabs.
u General decontamination procedures (270)
Cleaning of blue acrylic surfaces Information was added not to clean the blue acrylic
surfaces with ethanol.
u Cleaning the covers and doors (259)
Decontaminating rack trays Decontamination of rack trays was separated from
decontamination of sample racks. A maintenance task to
decontaminate rack trays was added.
u Decontaminating sample racks (276)
u Decontaminating rack trays (276)
Cleaning of processing module The maintenance procedure for cleaning the processing
module from the front was updated.
u To clean the processing module from the front p (255)
Cleaning up of processing module for
troubleshooting
The troubleshooting procedure to clean up the
processing module from the front was updated.
u Refer to the section To clean up the processing
module from the front in the User Assistance.
What is new in publication version 3.0
Strong magnetic field label Information added about this new safety label.
u Refer to the section List of safety labels on the system
in the User Assistance
List of supported sample tubes Update of the sample tube types and dimensions
supported by the system.
u List of supported sample tubes (292)
Minimum volumes for gel separator tubes New section listing the minimum sample volumes
required for gel separator tubes.
u Minimum sample volumes for gel separator
tubes (292)
Replacing the liquid waste container Previous task (Emptying the liquid waste container)
updated.
u Replacing the liquid waste container (111)
Barcode settings The minimum number of characters supported in
barcodes was updated.
u Refer to the section Barcode settings in the User
Assistance
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Automatic hibernation and startup Section for the new feature to set up a time to hibernate
or start up the system automatically.
u Refer to the section Automatic system hibernation and
startup processes in the User Assistance
New options to configure the LIS connection Steps added to include the new settings available for the
LIS connection.
u Refer to the section Defining the connection to the LIS
in the User Assistance
Defining regional settings Section for the new feature that allows configuring
default language and regional settings.
u Refer to the section Defining regional settings in the
User Assistance
Defining print and report settings Section for the new feature that allows configuring print
and report options.
u Refer to the section Defining print and report settings
in the User Assistance
Troubleshooting of open reagent cassette
drawer
What to do if you fin the reagent cassette drawer open
after restarting the system.
u Refer to the section Reagent cassette drawer open in
the User Assistance
What is new in publication version 2.1
User Assistance The section describing installation and use of the User
Assistance has been updated. The topic has also been
moved to a more prominent position within the
publication.
u Refer to the section User Assistance in the User
Assistance.
Starting up the system from off status A step explaining how to manually start up the IG server if
power switch 2 was set to "0" was added.
u Starting up the system from Off status (71)
/