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Cobas Liat System Update Guide - SW Ver. 3.3.1

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0% found this document useful (0 votes)
61 views19 pages

Cobas Liat System Update Guide - SW Ver. 3.3.1

Uploaded by

ahmed.alhamoo
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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cobas® Liat® system

Update Guide
Software Version 3.3.1

OS-01632-02
COBAS, LIAT and LIFE NEEDS ANSWERS are trademarks of Roche.

©2020-2021 Roche

Roche Diagnostics
9115 Hague Rd
Indianapolis, IN 46256
USA
www.roche.com
dialog.roche.com
3

Publication information

Publication version Software version Revision date Change description


OS-01632-01 3.3 August 2020 First version.
OS-01632-02 3.3.1 June 2021 Revised for Software version 3.3.1.
Revision history

Edition notice This publication is intended for operators of the cobas® Liat®
system.

The contents of this document, including all graphics and


photographs, are the property of Roche. No part of this document
may be reproduced or transmitted in any form or by any means,
electronic or mechanical, for any purpose, without the express
written permission of Roche.

Every effort has been made to ensure that the information is correct
at the time of publishing. Not all functionality described in this
manual may be available to all users. Roche Diagnostics reserves
the right to change this publication as necessary and without notice
as part of ongoing product development. Such changes may not
immediately be reflected in this document.

Screenshots Any screenshots in this publication are 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 This document is intended for the US market only.

Copyright ©2020-2021, Roche Diagnostics. All right reserved.

Trademarks The following trademarks are acknowledged.

COBAS, COBAS IT, COBAS INFINITY, LIAT and LIFE NEEDS


ANSWERS are trademarks of Roche.

All other product names and trademarks are the property of their
respective owners.

Feedback This document was created by the Roche Diagnostics Engineering


Operations department. Direct questions or concerns regarding
the contents of this document to:

Roche Diagnostics Corporation


Engineering Operations Department
9115 Hague Road
Indianapolis, IN 46256
USA

Document availability This document is available on the Roche Diagnostics USA website
at dialog.roche.com.

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Preconditions
From software version 3.3.0 to 3.3.1 update
Software version 3.3.0 is installed on the analyzer

to be updated.
From software version 3.2.0 to 3.3.1 update
• Software version 3.2.0 is installed on the analyzer
to be updated.
For all software update options:
• All results stored on the analyzer must be
exported and deleted before updating to software
version (SW) 3.3.1. (For SW 3.3, use Advanced
Tools > Archive and delete results).
For SW 3.2.0, if any results are detected by the
update process, the analyzer stops the update.
Restart the update after results are deleted, adding
additional time to the installation process.
»» Export and Delete Results might require
~20 minutes (e.g., when exporting 1000
results). The time required to Export and
Delete Results is proportional to the number
of results that must be exported and deleted.
»» Results from SW 3.2.0 cannot be restored onto
the updated analyzer.
»» Downgrading software from SW 3.3.1 to any
earlier version is not available once updates
have occurred.
• The software update process includes a
compatibility check step. The following times are
expected for the complete update process:
»» Software update - compatibility check step:
~10 – 20 minutes.
»» Software update final step: ~45 to 90 minutes.
• Before starting the SW 3.3.1 update, ensure the
date and time in the software is set to the current
date and time.
• For analyzers connected to a DMS network which
is not cobas® IT 1000 application or cobas®
infinity POC, your laboratory must ensure any
3rd party DMS provider supports the changes
implemented in SW 3.3.1 and must assess the
update process including consequences of a mixed

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configuration. Check the Host Interface Manual


for details.
Recommendations

• The audit trail is migrated during the update,


however, it is recommended to Export and Delete
the audit trail prior to starting the update to
improve performance and reduce the update time.
• It is recommended to create a Diagnostic Backup
if currently on SW 3.2.0. If on SW 3.3.0, you
might want to archive data.

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General update consideration (SW 3.3.0 to SW 3.3.1)

• Results will be kept during the update to SW 3.3.1.


It is recommended that the customer Archive
results
• The audit trail will be kept during the update to
SW 3.3.1. It is recommended that the customer
Archive
• Users on a SW 3.3.0 analyzer will be kept during
the update to SW 3.3.1.
• Lots, which are validated on SW 3.3.0 analyzers,
will be kept during the update, and therefore do
not need to be re-validated after the update.
• Exported Lots and Users with Advanced Tools
on SW 3.3.0 can be imported later on a SW 3.3.1
analyzer. Backup Analyzer and Export Settings
performed on SW 3.3.0 will not be able to be
imported to a SW 3.3.1 analyzer.
• It is recommended to create a Problem Report
immediately prior to starting the update.
• The software update process includes a
compatibility check step. The following time is
expected for the complete update process.
»» Compatibility Check and Software update:
~ 15 minutes.
»» The time to update depends on several factors
such as the amount of data stored on the
analyzer.
• Before starting the SW version 3.3.1 update, make
sure that the date and time in the software is set to
the present date and time. The date and time will
be kept during the update.
• After successful update, check that the date and
time are correct.
• After the update, the setting for Automatic
Release of Results will be off by default, and must
be turned on in the settings according to the user’s
need.
• All existing configuration settings including
Problem Report settings, Connectivity settings,
and Printer settings will be kept during the update
to SW 3.3.1.

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• During the update process, a progress bar in the


analyzer User Interface (UI) might appear to
not progress during the update. Do not stop the
update process.
• During the software update process, the user will
be prompted to reboot the analyzer to complete
the update.
• Warning: Disconnecting the power or pushing
the power-down button during the update could
corrupt the software and damage the analyzer
requiring a repair at a repair depot.
• For network-connected analyzers, network
settings will be kept: Due to a known issue
(See KIL issue 3643), analyzers with SW 3.3.1
configured to use a server name as the host on a
host which cannot resolve DNS names properly,
will not be allowed to connect to the network.
Therefore, analyzers with SW 3.3.0 connected
to servers that cannot resolve DNS, should be
configured to use an IP address for the server
name prior to the update to SW 3.3.1. Alternately,
the customer’s server can be configured to resolve
DNS.
• Compatibility of SW 3.3.0 and SW 3.3.1 in a
network:
A mixed configuration of SW 3.3.0 and SW 3.3.1
analyzers on a customer’s network environment
(network share or DMS environment) are fully
compatible.
• After an upgrade to SW 3.3.1, it is not possible
to downgrade the analyzer to a lower software
version.

Roche Diagnostics
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General update consideration (SW 3.2.0 to SW 3.3.1)

• Results will not be migrated during the update to


SW 3.3.1. Users must Export and Delete Results
prior to the update. Results cannot be restored
onto the updated analyzer.
• Export and Delete Results may require ~ 20
minutes (e.g., when exporting 1000 results). The
time required to Export and Delete Results is
proportional to the number of results that must be
exported and deleted.
• The audit trail is migrated during the update. It
is recommended that the customer Export and
Delete the audit trail prior to starting the update
as a backup and to improve performance and
reduce the update time.
• Users on a SW 3.2.0 analyzer will be migrated to
SW 3.3.1.
• Lots which are validated on software version 3.2.0
analyzers are migrated during the update, and
therefore do not need to be re-validated after the
update.
• Advanced Tools Key functions used in SW 3.2.0
cannot be used on a SW 3.3.1 analyzer after the
upgrade.
• It is recommended to create a Diagnostic Backup
immediately prior to starting the update.
• The software update process includes a
compatibility check step. The following times are
expected for the complete update process.
»» Software update - compatibility check step: ~
10-20 minutes.
»» Software update final step: ~25 minutes.
»» Total install time: ~35 to ~45 minutes
»» The time to update depends on several factors
such as the amount of data stored on the
analyzer.
• Before starting the update to SW 3.3.1 from
SW 3.2.0, ensure the date and time in the software
is set to the present date and time.

Roche Diagnostics
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• After successful update, the ADMIN must reset


the analyzer date and time to the correct local date
and time. This is due to a technical issue in which
the analyzer time is shifted during the update.
Additionally ensure that the time zone setting is
correct.
• Printer settings will not be migrated during the
update to SW 3.3.1. Users will need to reconfigure
the Report and Results Printer settings after
update.
• During the update process, a progress bar in the
analyzer User Interface (UI) might appear to
not progress during the update. Do not stop the
update process.
• During the software update process, the user will
be prompted to reboot the analyzer to complete
the update.
• After the update, the setting for Automatic Release
of Results will be off by default, and must be
turned on in the settings according to the User’s
need.
• Warning: Disconnecting the power or pushing
the power-down button during the update could
corrupt the software and damage the analyzer
requiring a repair at a repair depot.
• If the SW 3.2.0 analyzer System Setting Name of
Machine is not the serial number of the analyzer
prior to update, it will not remain the same after
the update. After the update, ensure the setting
Name of Analyzer is as desired in the user
interface Main Menu > Settings > System.
• For network-connected analyzers network settings
will be migrated: Due to a known issue (See KIL
issue 3643), analyzers with SW 3.3.1 configured
to use a server name as the host on a host which
cannot resolve DNS names properly, will not be
allowed to connect to the network. Therefore,
analyzers with SW 3.2.0 connected to servers that
cannot resolve DNS, should be configured to use
an IP address for the server name prior to the
update to SW 3.3.1. Alternately, the customer’s
server can be configured to resolve DNS.

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• Compatibility of SW 3.2.0 and SW 3.3.1 in a


network:
A mixed configuration of analyzers with
software versions 3.2.0 and 3.3.1 on a customer’s
network environment (network share or DMS
environment) will require special consideration.
This mixed configuration can occur in the
following cases:
1. Not all analyzers in use on a network are
updated to SW 3.3.1 at one time.
2. New analyzers (with SW 3.3.1) are installed
into an existing network of SW 3.2.0 analyzers.
3. An analyzer is returned from repair
(updated to SW 3.3.1) and replaced into the
environment that still has SW 3.2.0 analyzers.
4. For case 2. and 3. the analyzer must be logged
onto as ADMIN the first time to initialize
encryption and allow syncing on the network.
• Roche strongly recommends that all analyzers on
either a share network or a DMS/LIS network be
updated to SW 3.3.1 before any analyzer is used to
ensure full compatibility. Please include updates
to DMS or LIS (where necessary) in the planning
to ensure support of the full feature set.
• After an upgrade to SW 3.3.1, it is not possible
to downgrade the analyzer to a lower software
version.

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Logging on as ADMIN after update

In the following situations, the analyzer must be


initially logged on to by the customer as ADMIN
at first use in order to initialize the encryption and
enable the other users to log on.
• Analyzers updated from SW 3.2.0 to SW 3.3.1
• New analyzers delivered with SW 3.3.1
• SW 3.3.1 analyzers that had Factory Reset
performed
• Repaired analyzers updated to SW 3.3.1
Networks consisting of only SW 3.3.0 and SW 3.3.1
analyzers are completely compatible with each other.
However, the changes implemented in SW 3.3.1 may
not be available to analyzers still on SW 3.3.0 such as
sending aborted and invalid results and transmitting
Ct values.
Be aware that as with the previous update from SW
3.2.0 to SW 3.3.0, special considerations are needed
for mixed software configurations of analyzers in a
DMS network environment or share environment.
For example, updated Replacements, or Repaired
analyzers as well as new analyzers that are placed at
an existing site will result in a mixed configuration
with SW 3.2.0 analyzers in the existing network
environment.

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Install Source / Share Location considerations

The three Install Source locations and the Share Lot


Folder are referred to as Share Locations after the
software version 3.3.1 update. These locations migrate
and appear in the analyzer user interface as shown in
the following table.
Existing SW version 3.2 Migrated SW version 3.3 Protocol
Install Source locations Share locations
Share Lot Folder Share Lot Folder SMB*
Share Folder Network Share 1 SMB*
Network Share 2 SMB*
Network Share 3 SMB*
LAN FTP FTP Share 1 FTP
Service FTP FTP Share 2 FTP
FTP Share 3 (new) FTP
*For analyzers updated and running software version 3.3.1, the Share
location SMB network protocol must be SMBv2.1 or higher.

Share Lot Folder:


• The Share Lot Folder settings are migrated on the
analyzer.
• During the update of any analyzer in a network
using Share Lot Folder, no runs should be
performed on any other network-connected
analyzer during the update.
Share Lot Folder “Stored Results”:
• After the update to software version 3.3.1,
previously existing results stored in the Share Lot
Folder are no longer accessible by the updated
analyzer, but remain in the original network
storage location.

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Share Lot Folder “Shared Assay Tube Lots” and


“Used Tubes”:
• After the software version 3.3.1 update from
software version 3.2.0, existing shared Assay Tube
Lots and Used Tubes in the Share Lot Folder are
available to the updated analyzer.
• Before updating the first analyzer on the share
network to software version 3.3.1 from software
version 3.2.0, users should perform a complete
backup of the respective share network storage.
• During the update of all the connected analyzers,
do not perform any runs (especially Lot
Validation runs) on any connected analyzer, until
all analyzers on the share network using the Share
Lot Folder are updated to software version 3.3.1.
See Warning regarding mixed configuration.
• Warning: If a mixed configuration of analyzers
with both software version 3.2.0 and software
version 3.3.1 are on the same share network,
shared assay tube lots created on the software
version 3.3 analyzer are not properly shared to
software version 3.2 analyzers. New assay tube
lots should be added only to software version 3.2
analyzers while there is a mixed configuration.
• For more information, refer to the User
Guide, section Connectivity > Share locations
configuration.

Roche Diagnostics
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For Axeda connected Users

• A message displays that a software update is


available as described in the current cobas Liat
User Guide version 10.0.
• Results should be exported and deleted prior to
selecting Update.
• If the update message is dismissed, the message
update might not appear immediately at a later
login. If the message for the update does not
appear immediately for Admin level users, then
log off, log on after 30 minutes.
• Administrator level users are able to select
Update, initiating the upgrade compatibility
check.
»» Message on screen says Press <Continue>,
user should press Update.
• After the compatibility check is passed successfully
and, if no results are found, the user is prompted
to Update the software. This message could take
up to 20 minutes to appear.
• Do not choose Cancel at this point. Doing
so stops the software update, and deletes the
Axeda deployment package from the analyzer.
If this happens, Roche support must re-deploy
the package in Axeda to the customer, or the
customer must use a USB software update flash
drive instead.
• Axeda proxy server configuration is not migrated
and might need to be re-configured through the
User Interface after update for customers using a
proxy server.

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For DMS connected Users

• DMS Connected analyzers require additional


consideration for the software 3.3.1 update as
indicated below.
• During the process of updating several analyzers
which are all connected to a DMS network such as
cobas IT 1000 application or cobas infinity POC,
necessarily there will be a mixed configuration of
both software version 3.2.0 and software version
3.3.1 analyzers in the DMS network temporarily.
Be aware of the limitations of this mixed
configuration as detailed below.
• It is recommended to update all analyzers in the
DMS-connected environment before using any
of them if possible to avoid the limitations of a
mixed configuration of software version 3.2.0
and software version 3.3.1 analyzers on the DMS
network.
For customers with cobas Liat instruments
connected to a third party Data Management
System (e.g., Abbott RALS Web or Telcor QML),
consult with your DMS provider prior to starting
an upgrade to cobas Liat software version 3.3.1.

• Analyzers with software versions 3.3.0 and 3.3.1


on a shared DMS network will be fully compatible
with each other. There are no specific challenges
in a mixed environment of software versions 3.3.0
and 3.3.1 analyzers that are connected to either
the cobas IT 1000 application or cobas infinity
POC application.
The DMS functionality in software version 3.3.1
(e.g., Logging Debug Optimization, AutoRelease of
results, Tilt sensing) will result in analyzers with
the different versions behaving differently.

Roche Diagnostics
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cobas IT 1000 or cobas infinity POC considerations

cobas IT 1000/cobas infinity POC applications:


It is recommended that the installation is updated to
the newest cobas IT 1000 application version 2.10.01
or higher (including cobas infinity POC application
V2.0.1 or higher) be installed before updating
analyzers to software version 3.3.1 within a DMS
network.
• cobas IT 1000 application versions below 2.08
do not support any POCT1-A driver version for
cobas Liat analyzer.
• If a cobas IT 1000 application version older than
V2.10 is used, some analyzer software version 3.3
functionality will be unavailable such as:
»» Patient verification type “VISIT ID#” and
“ORDER ID#” will not be available on
software version 3.3 analyzers.

cobas IT 1000 POCT1-A driver:


The driver version cobas Liat POCT1A v1.4.0
or higher must be installed before any analyzer is
updated to software version 3.3 to ensure minimum
supported version requirements (refer to cobas IT
1000 Instrument Driver Compatibility Matrix).
Although not recommended, if a driver version older
than cobas Liat POCT1A v1.4.0 is used the analyzers
will function normally but the following analyzer
software version 3.3.1 functionality might be limited
as follows:
• May not be able to use Patient Verification
• May not be able to perform Device Configurations
for newly implemented configurations.
• Aborted results: The message cannot be
interpreted nor displayed in the DMS. Invalid
results, however, will be transmitted and the runs
will be displayed in the DMS.
• Values will not be received by the DMS nor
displayed.

Roche Diagnostics
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• Assay scripts not supported in Driver version


cobas Liat POCT1A v1.4.0.
The driver version cobas Liat POCT1A v1.1.0 or
higher must be installed before any analyzer is
updated to software version 3.3.1 to ensure minimum
supported version requirements.

Roche Diagnostics
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Managing Assay Tube Lots in a network with mixed


analyzer software version configurations:
Due to the change from 4-digit abbreviated lot
number to 6-digit lot number transmitted on the
network, when a network of analyzers is in mixed
configuration of software version 3.2.0 and software
version 3.3.1 in a DMS environment, there is a
limitation on sharing assay tube lots. While the
mixed configuration exists on the DMS network, any
new assay tube lots added on software version 3.3.1
analyzers will not be useable on software version 3.2.0
analyzers as software version 3.2.0 supports the use of
4-digit abbreviated lot numbers only. New assay tube
lots should be added only to a software version 3.2.0
analyzer while connected in this mixed configuration
to ensure both 3.2.0 and 3.3.1 analyzers have access to
the Lots.

Beware that adding and synchronizing the same


Tube Lots on a software version 3.3.1 analyzer and
a software 3.2.0 analyzer may result in unwanted
sharing behavior due to the different 4-digit and
6-digit formats used by DMS.

For customers with cobas Liat instruments


connected to a third party Data Management
System (e.g., Abbott RALS Web or Telcor QML),
consult with your DMS provider on available
functionality provided with cobas Liat software
version 3.3.1.

Roche Diagnostics
cobas® Liat® system · Update Guide · Software Version 3.3.1
OS-01632-02

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