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0% found this document useful (0 votes)
317 views148 pages

Cobas Liat User Manual SW 3 1

Uploaded by

john
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

Operator’s Manual
Version 7.2

Software Version 3.1


COBAS, LIAT and LIFE NEEDS ANSWERS are trademarks of Roche.

©2017 Roche

Roche Diagnostics
9115 Hague Rd
P.O. Box 50457
Indianapolis, IN 46250-0457
USA
www.roche.com
https://usdiagnostics.roche.com
i

Publication information

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.


Caution: Federal law restricts this device to sale by or on the
order of a physician.

Copyright ©2014 - 2017, Roche Diagnostics. All right reserved.

Trademarks The following trademarks are acknowledged.

COBAS, 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 Roche Diagnostics GmbH


(operator manual content) and the Roche Diagnostics Engineering
Operations department (US Supplement). Direct questions or
concerns regarding the contents of this document to:

Roche Diagnostics Corporation


Engineering Operations Department
9115 Hague Road
P.O. Box 50457
Indianapolis, IN 46250-0457
USA

Document availability This document is available on the Roche Diagnostics USA website
at https://usdiagnostics.roche.com.

Roche Diagnostics
Operator’s Manual US Supplement
08276340001
ii

Roche Diagnostics
Operator’s Manual US Supplement
08276340001
US Supplement US - 1

Warranty for the instrument

Roche warrants the instrument against defects in materials and


workmanship (except for consumable items and lamps) for a
period of one year (90 days in the case of parts in direct contact
with reagents). Roche, at its option, either replaces or repairs free of
charge, on an f.o.b. Indianapolis, Indiana basis, all instruments and
parts which prove to be defective and are subject to such warranty.

Field-installed options, modifications, and used equipment carry


a ninety (90) day parts and labor warranty. Any component
part(s) and labor necessary to complete a repair are guaranteed for
thirty (30) days. Some replacement components, such as printers,
monitors, etc., may carry a longer warranty.

This warranty does not apply to instruments not installed by a


Roche Field Service Representative/Field Application Specialist
(or authorized agent of Roche) and/or not used according to
instructions or damaged by accident, alteration, misuse, tampering,
and/or abuse.

We warrant that the services provided under a Roche Warranty


or Service Agreement are free from defects in workmanship for a
period of thirty (30) days from the date of service.

Warranty for the reagent

Roche warrants that this product will meet the specifications stated
in the labeling when used in accordance with such labeling and
will be free from defects in material and workmanship until the
expiration date printed on the label.

WE HEREBY DISCLAIM ALL OTHER WARRANTIES, WHETHER


EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE,
WITH RESPECT TO THE EQUIPMENT, REAGENTS AND SERVICES
PROVIDED, EXCEPT THE LIMITED WARRANTY SET FORTH
ABOVE. WE ARE NOT LIABLE FOR ANY INCIDENTAL, INDIRECT,
SPECIAL OR CONSEQUENTIAL DAMAGES, INCLUDING BUT NOT
LIMITED TO, LOST PROFITS OR REVENUES, LOSS OF THE USE OF
THE CAPITAL, COST OF SUBSTITUTE EQUIPMENT, REAGENTS,
FACILITIES OR SERVICES AND/OR DOWN-TIME COSTS RESULTING
FROM OR ARISING IN CONNECTION WITH THE PERFORMANCE,
DELAY IN PERFORMANCE OR NONPERFORMANCE OF ANY
TERM OR CONDITION OF A ROCHE WARRANTY OR SERVICE
AGREEMENT OR FROM THE USE OR MISUSE OF THE INSTRUMENT
(OR ANY SUBSTITUTE THEREFORE) OR REAGENTS OR ANY
MATERIALS OR WORKMANSHIP DELIVERED HEREUNDER, EVEN
IF WE HAVE BEEN ADVISED, KNEW OR SHOULD HAVE KNOWN OF
THE POSSIBILITY OF SUCH DAMAGES. YOUR EXCLUSIVE REMEDY
WITH RESPECT TO OUR WARRANTY OF ANY EQUIPMENT,
REAGENTS OR PARTS SHALL BE REPAIR OR REPLACEMENT OF
THE DEFECTIVE ITEM(S), AT OUR OPTION. AS YOUR EXCLUSIVE
REMEDY FOR ANY SERVICE PERFORMED UNDER THIS LIMITED
WARRANTY WE SHALL RE-PERFORM ANY SERVICE WHICH WAS
DEFECTIVE.

Roche Diagnostics
Operator’s Manual US Supplement
08276340001
US - 2 US Supplement

Contact Support and/or Service Representatives

Roche provides 24 hour-a-day, 365 day-a-year telephone assistance.


In addition, on-site service is provided in a timely manner. In
order for us to comply with federal record keeping requirements, if
you need to contact your Roche Diagnostics service representative,
call the appropriate Customer Support Center number listed below.
They, in turn, notify your representative to contact you.

Chemistry, Immunology, Automation & Urinalysis products 1-800-428-2336

The Customer Support Center answers all calls pertaining to


Roche products. If the Customer Support Center cannot resolve a
problem by phone, a Roche representative is dispatched.

Service policy questions Questions relating to your service policy can be referred to your
local Roche representative or the regional service manager by
calling the appropriate Customer Support Center number.

Customer Training

Roche Diagnostics conducts Indianapolis-based operator training


courses and/or field-based training depending upon the instrument
or system you purchased. Please contact your Roche Diagnostics
representative for course availability and scheduling.

Ordering Information

Order replacement parts, consumable materials, reagents,


standards, calibrators and controls as necessary from Roche. Please
use the catalog number and reference name for each item when
placing an order with Roche Customer and Business Support
Center.

Roche Customer and Business Support Center number 1-800-428-5030

Contacting Sales Representatives

If you wish to contact your sales representative, he or she may be


reached by calling Customer and Business Support Center or by
leaving a message on their voice mail.

Roche Customer and Business Support Center number 1-800-428-5076

Voice mail 1-800-845-7355


Entering the appropriate mailbox number or press # to spell the
name.

Roche Diagnostics
Operator’s Manual US Supplement
08276340001
US Supplement US - 3

Customer Communications

As the need arises, you shall receive various customer


communications concerning information about your system. These
updates are usually in one of the following forms.

Customer communications can also be viewed on the internet.


Some documentation is available online only.
Go to https://usdiagnostics.roche.com and select Documentation.

Bulletins Bulletins (Reagent, Software, or Analyzer) are printed on Roche


Diagnostics letterhead. Bulletins contain information that is vital
to the performance of your system. Bulletin information should
be communicated internally to all analyzer operators. Bulletins
should be kept on file until the reagent expires, you receive updated
labeling or you are notified by Roche Diagnostics to discard them.

Urgent Medical Device Correction or Removal Urgent Medical Device Correction or Removal is printed on Roche
Diagnostics letterhead with the words Urgent Medical Device
Correction or Urgent Medical Device Removal. These require
immediate attention by the analyzer operator and are to be filed for
reference until further notice.

Customer Letters Customer Letters are printed on Roche letterhead and contain
general information or attachments that you may place in your
files. You may discard Customer Letters after reading and following
any applicable instructions contained in them.

Product Announcement Product Announcements are usually announcing product


launches. They contain specific details about a new product such
as features and benefits, kit configuration and pricing. Product
Announcements may or may not be discarded depending on your
laboratory’s preference.

CLIA/CLSI Compliance

Roche documentation, which includes this operator’s manual,


methods sheets and active customer bulletins, conforms with
the guidelines in effect at the time of publication listed in the
Code of Federal Regulations (CFR) and the Clinical Laboratory
Standards Institute (CLSI) General Laboratory Practices and Safety
Guidelines. Documentation also meets the Centers for Medicare
and Medicaid Services, formerly known as Health Care Financing
Administration, interpretation of the requirements for the Clinical
Laboratory Improvement Amendments (CLIA ‘88).

Roche Diagnostics
Operator’s Manual US Supplement
08276340001
US - 4 US Supplement

Contacting Commercial Education

The documentation you receive to operate your system, prepare


and/or utilize reagents, is created by several departments within
Roche. The Commercial Education department produces most of
the training documentation you receive here in Indianapolis, or at
your on-site training.

To contact Commercial Education Ÿ send an email to [email protected]

Provide your name and account number when contacting us. We


will get back to you, or fill your request, as soon as possible.

If you have any questions on documentation that is not of a


training nature, contact the appropriate Customer Support
Center as designated in the Contact Support and/or Service
Representative section.

To Change Mailing Addresses or Contact Names

There are several ways to change your mailing address or the


contact name for your account. You may send an email, leave a
message or go to https://usdiagnostics.roche.com

Please provide your name and account number when contacting us.
Your account number is provided to you by a Roche representative
when your analyzer is installed.

Email [email protected]

https://usdiagnostics.roche.com Contact > Contact Change Form.

Roche Diagnostics
Operator’s Manual US Supplement
08276340001
cobas® Liat® System
Operator's Manual
Version 7.2

Software version 3.1


2

Publication information

Publication Software version Revision date Change description


version
4.0 2.0 March 2015 Clerical updates, text revisions.
5.0 2.1 December 2015 First publication in Roche user documentation format.
6.0 2.1.1 February 2016 Auto-lock feature.
Branding amendments.
Address and intended use amendments.
7.0 3.0 May 2016 Liat images updated.
7.1 3.0 September 2016 Addition of Consult operating instructions advisory symbol.
Addition of laser transmission cautionary label.
Removal of image from Labels on the analyzer section.
7.2 3.1 April 2017 Audit trail.
Extensions for printer installation.
Additional features for logon procedures and user
management.
Logon with badge barcode.
Recommendations for inspection of printed barcode labels.
Extensions for reviewing results.
Extensions for export and delete results.
Extensions for DMS connectivity.
Color printing.
Data migration.
Extensions for error codes. Differentiation between software,
hardware/firmware, and assay codes.
Extensions for troubleshooting.
Addition of other environmental conditions.
Additional Caution statements.
Updates of screenshots and text for changes in user interface.
u What is new in publication version 7.2 (12)
y Revision history

Edition notice This publication is intended for operators of the


cobas® Liat® 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 cobas® Liat® System Operator’s Manual contains
all information about the product, including the following:
• Safety
• Installation
• Routine operation
• Maintenance and calibration
• Troubleshooting information
• Configuration information
• Background information

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
3

The cobas® Liat® Analyzer Quick Start Guide is


intended as a reference during the
cobas® Liat® Analyzer setup.

The cobas® Liat® Cleaning Tool Guide is intended as


an instruction for using the cobas® Liat® Cleaning Tool
with the cobas® Liat® Analyzer.

The cobas® Liat® Advanced Tools Key Guide is


intended as an instruction for performing a variety of
functions, including backing up data and syncing assay
lots between cobas® Liat® Analyzers.

The cobas® Liat® Analyzer Host Interface Manual


POCT1-A (EDI) contains all necessary information about
the EDI interface.

The cobas® Liat® Analyzer Host Interface Manual


POCT1-A (DML) contains all necessary information
about the DML interface.

! General attention
To avoid incorrect results, ensure that you are familiar
with the instructions and safety information.
r Pay particular attention to all safety notices.
r Always follow the instructions in this publication.
r Do not use the software in a way that is not described
in this publication.
r Store all publications in a safe and easily retrievable
place.

Screenshots The screenshots in this publication have been added


exclusively for illustration purposes. Configurable and
variable data, such as tests, results, or path names visible
therein must not be used for laboratory purposes.

Warranty Any customer modification to the analyzer and the use of


unauthorized assay tubes or accessories renders the
warranty null and void.

Do not open the cobas® Liat® Analyzer, change a


component or install unauthorized software.

Copyright © 2014-2017, Roche Molecular Systems, Inc.

Trademarks The following trademarks are acknowledged:

COBAS and LIAT are trademarks of Roche.

All other product names and trademarks are the property


of their respective owners.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
4

Patents See http://www.roche-diagnostics.us/patents

Support If you have any further questions, please contact your


Roche representative with the system information
collected as described in the Troubleshooting chapter in
the cobas® Liat® System Operator's Manual.

Approvals The cobas® Liat® Analyzer meets 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.

Compliance with the applicable directive(s) is provided by


means of the Declaration of Conformity.

The following marks demonstrate compliance:

IVD IN VITRO DIAGNOSTIC MEDICAL DEVICE

Complies with the provisions of the applicable EU


directives.

Issued by TÜV Rheinland for Canada and the US.

'Laboratory Equipment' is the product identifier as


shown on the type plate.

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 local Roche representative, should
you have any such feedback.

In the U.S., call the following number: 1-800-800-5973.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
5

Contact addresses

Roche Molecular Systems, Inc.


1080 US Highway 202 South
Branchburg, NJ 08876
USA

Roche Diagnostics GmbH


Sandhofer Strasse 116
68305 Mannheim
Germany

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
6

Table of contents
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Symbols and abbreviations . . . . . . . . . . . . . . . . . . . 9
What is new in publication version 7.2 . . . . . . . . . 12
Safety instructions . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Installing the analyzer . . . . . . . . . . . . . . . . . . . . . . . 17
About the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
About the analyzer functions . . . . . . . . . . . . . . . . . 22
Overview of the analyzer operating elements. . . . 24
About assays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Overview of the touch screen . . . . . . . . . . . . . . . . . 26
Touch screen elements . . . . . . . . . . . . . . . . . . . 26
Common user actions . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Starting the analyzer . . . . . . . . . . . . . . . . . . . . . . . . 28
Logging on . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Changing your password. . . . . . . . . . . . . . . . . . . . . 31
Assigning or changing your badge barcode. . . . . 34
Selecting items on the screen. . . . . . . . . . . . . . . . . 36
Selecting predefined values . . . . . . . . . . . . . . . . . . 36
Entering text and numbers . . . . . . . . . . . . . . . . . . . 37
Scanning barcodes. . . . . . . . . . . . . . . . . . . . . . . . . . 37
About locking the analyzer . . . . . . . . . . . . . . . . . . . 39
Locking the analyzer manually . . . . . . . . . . . . . . . . 41
Unlocking the analyzer . . . . . . . . . . . . . . . . . . . . . . 42
Switching off the analyzer . . . . . . . . . . . . . . . . . . . . 44
Performing a run. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Running an assay . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Aborting an assay run . . . . . . . . . . . . . . . . . . . . . . . 49
Result handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
About results . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Reviewing results . . . . . . . . . . . . . . . . . . . . . . . . 53
Exporting and deleting results . . . . . . . . . . . . . 57
Setting up the analyzer . . . . . . . . . . . . . . . . . . . . . . . . . 60
Defining values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
Installing and updating assays . . . . . . . . . . . . . . . . 62
Installing or updating assays from a USB key 62
Installing or updating an assay from the
Roche remote service platform. . . . . . . . . . . . . 64
Installing an assay from a local source . . . . . . 66
Registering assays . . . . . . . . . . . . . . . . . . . . . . . 68
Adding an assay tube lot . . . . . . . . . . . . . . . . . . 70
Deleting assay tube lots. . . . . . . . . . . . . . . . . . . 74
Uninstalling assays . . . . . . . . . . . . . . . . . . . . . . . 76
Viewing and printing assay tube lot information . 77
Defining system settings . . . . . . . . . . . . . . . . . . . . . 78

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
7

System settings . . . . . . . . . . . . . . . . . . . . . . . . . . 79
About authentication modes. . . . . . . . . . . . . . . 80
Network definitions . . . . . . . . . . . . . . . . . . . . . . . . . 81
Network resources . . . . . . . . . . . . . . . . . . . . . . . . . . 81
Defining network resources . . . . . . . . . . . . . . . 82
Using the share lot function . . . . . . . . . . . . . . . 83
Connections to a host system. . . . . . . . . . . . . . . . . 85
Defining settings for host systems . . . . . . . . . . 85
About data exchange with a DMS . . . . . . . . . . 86
Connecting the analyzer to a DMS . . . . . . . . . 88
Managing users . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
Overview of user account access roles . . . . . . 90
About user IDs and passwords. . . . . . . . . . . . . 91
Defining new users. . . . . . . . . . . . . . . . . . . . . . . 91
Changing user information . . . . . . . . . . . . . . . . 94
Deleting a user account. . . . . . . . . . . . . . . . . . . 95
Updating the software . . . . . . . . . . . . . . . . . . . . . . . 97
Registering the software . . . . . . . . . . . . . . . . . . . . . 100
Viewing software and hardware information . . . . 102
Viewing information about the analyzer and
software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
Viewing system information . . . . . . . . . . . . . . . 103
Quality control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
Maintenance and calibration . . . . . . . . . . . . . . . . . . . . 105
About self-check . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
About auto monitoring. . . . . . . . . . . . . . . . . . . . . . . 105
About auto adjustment . . . . . . . . . . . . . . . . . . . . . . 106
About service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
Calibrating the touch screen. . . . . . . . . . . . . . . . . . 107
Cleaning the analyzer. . . . . . . . . . . . . . . . . . . . . . . . 107
Cleaning the outside of the analyzer . . . . . . . . 109
Cleaning spillages or leakages from an assay
tube. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111
List of error messages . . . . . . . . . . . . . . . . . . . . . . . 111
Generating a backup for troubleshooting
purposes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124
Viewing and printing the event log . . . . . . . . . . . . 124
Resetting the lost default administrator
password . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Cleaning the window of the barcode reader . . . . 127
Resolving a tube entry door error before the start
of a run. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
Resending results manually . . . . . . . . . . . . . . . . . . 128
Restarting an unresponsive analyzer . . . . . . . . . . . 129
Technical data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
Technical characteristics . . . . . . . . . . . . . . . . . . . . . 130
Environmental conditions . . . . . . . . . . . . . . . . . . . . 130
Storage and transport conditions. . . . . . . . . . . . . . 131
Standard supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . 131
Printer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
8

Index. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Preface 9
Intended use

Preface

Intended use
The cobas® Liat® Analyzer is an automated nucleic acid
test instrument, that when used together with
cobas® Liat® assay tubes to perform in vitro diagnostic
tests, is referred to as the cobas® Liat® System. In
conjunction with a cobas® Liat® assay tube, the
instrument performs reagent preparation, target
enrichment, inhibitor removal, nucleic acid extraction,
polymerase chain reaction (PCR) amplification, real-time
detection, and result interpretation to automate the
detection or quantification of nucleic acid targets in a
biological sample.

Symbols and abbreviations


Product names Except where the context clearly indicated otherwise, the
following product names and descriptors are used.

Product name Descriptor

cobas® Liat® Analyzer analyzer

cobas® Liat® Assay Tube assay tube

cobas® Liat® Cleaning Tool cleaning tool

cobas® Liat® Advanced Tools Key advanced tools key

cobas® Liat® Quality Control Kit quality control kit

y Product names

Symbols used in the publication


Symbol Explanation
o List item
u Related topics containing further information
Tip. Extra information on correct use or useful
q
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.
d Materials that are required for a task.
j Prerequisites of a task.
u Topic. Used in cross-references to topics.
y Symbols used in the publication

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
10 Preface
Symbols and abbreviations

Symbol Explanation
p Task. Used in cross-references to tasks.
Figure. Used in figure titles and cross-
w
references to figures.
Table. Used in table titles and cross-references
y
to tables.
Equation. Used in cross-references to
z
equations.
Code example. Used in code titles and cross-
k
references to codes.
y Symbols used in the publication

Symbols used on product


Symbol Explanation

Global Trade Item Number.

Humidity limits.

Keep upright.

Fragile handle with care.

Keep dry.

Keep away from sunlight.

Stacking limit by mass.

Stacking limit by number.

Recyclable.

Consult operating instructions.

y Symbols used on product

Abbreviations The following abbreviations are used.

Abbreviation Definition
AD Amplification and detection
ANSI American National Standards Institute
y Abbreviations

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Preface 11
Symbols and abbreviations

Abbreviation Definition
CFR Code of Federal Regulations
CISPR Comité International Spécial des
Perturbations Radioélectriques (International
Special Committee on Radio Interference)
CSA Canadian Standards Association
DML Device messaging layer
DMS Data management system
EC European Community
EN European standard
FTP File transfer protocol
HIS Hospital information system
HL7 Health Level Seven
IEC International Electrical Commission
IP Internet provider
IVD In vitro diagnostic
LAN Local area network
LIS Laboratory information system
n/a not applicable
NA Not available
NAT Nucleic acid test
PCR Polymerase chain reaction
POCT Point of care testing
RF Radio frequency
QC Quality Control
SD Standard deviation
SL Shared lot
SNTP Standard network time protocol
UPS Uninterruptible power supply
URI Uniform resource identifier
WEEE Waste Electrical and Electronic Equipment
WLAN Wireless LAN
WPA2 Wireless protected access 2
y Abbreviations

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
12 Preface
What is new in publication version 7.2

What is new in publication version 7.2


Printing The procedure how to install a USB printer was extended.
A procedure how to install a network printer was added.
Information about color printing was added.
u Installing the analyzer (17)
u System settings (79)

Audit trail Information about the audit trail feature was added.
u About the audit trail (23)

Logon procedures The procedure how to log on was reworked to cover the
different authentication modes. The procedure how to
change your password was reworked. A procedure how
to assign or change your badge barcode was added.
u Logging on (29)
u Changing your password (31)
u Assigning or changing your badge barcode (34)

Inspection of printed barcode labels Recommendations for inspection of printed barcode


labels were added.
u Scanning barcodes (37)

User management Requirements for user IDs and passwords were added.
The procedures how to define a new user and how to
change user information were reworked to cover the new
features (e.g., locking users, assigning badge barcodes,
change password at first logon).
u Managing users (90)

Reviewing results The procedures how to review results were reworked.


u Reviewing results (53)

Export and delete results The former functions for moving results and deleting
results were combined to one function for exporting and
deleting results. The corresponding procedures were
combined and reworked.
u Exporting and deleting results (57)

Sharing assay tube lots Information about ways to share assay tube lots between
different analyzers was added.
u Sharing assay tube lots (70)

Authentication modes Information about the supported authentication modes


was added.
u About authentication modes (80)

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Preface 13
What is new in publication version 7.2

DMS connectivity Information about the data exchange with a DMS was
added. A procedure how to connect the analyzer to a
DMS was added. Information how to disconnect the
analyzer from a host was added.
u Connections to a host system (85)

Data migration Information about the impact of the software update on


the user information was added.
u About migration of user information (97)

Error codes The error codes were differentiated between software,


hardware/firmware, and assay codes. The list of error
messages was extended.
u List of error messages (111)

Troubleshooting Troubleshooting procedures were reworked and added.


u Troubleshooting (111)

Other environmental conditions Information about other environmental conditions was


added.
u Other environmental conditions (131)

Caution statements Caution statements about the risks of power interruption,


contamination of the cleaning tool, and data security
were added.
u Installing the analyzer (17)
u Cleaning spillages or leakages from an assay
tube (110)
u Generating a backup for troubleshooting
purposes (124)

Changed user interface The user interface was changed with software version 3.1.
Screenshots and text were updated to reflect the
changes.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
14 Preface
Safety instructions

Safety instructions
Safety classification The safety precautions and important user notes are
classified according to the ANSI. Familiarize yourself with
the following meanings and icons:

! Safety alert symbol


r The safety alert symbol is used to alert you to potential
physical injury hazards. To avoid possible injury or
death, comply with all safety messages that follow this
symbol.

These symbols and signal words are used for specific


hazards:

! WARNING
Warning…
r …indicates a hazardous situation that, if not avoided,
could result in death or serious injury.

! CAUTION
Caution…
r …indicates a hazardous situation that, if not avoided,
could result in minor or moderate injury.

NOTICE
Notice…
r …indicates a hazardous situation that, if not avoided,
may result in damage to the analyzer.

Safety summary To avoid serious injury, read and comply with the
following safety precautions.

! WARNING
Insufficient knowledge and skills
As an operator, ensure that you know the relevant safety
precaution guidelines and standards and the information
and procedures contained in these instructions.
r Only trained personnel may operate the
cobas® Liat® Analyzer. Operators must have received
and read the comprehensive instructions for the use,
quality control, and care of the
cobas® Liat® Analyzer.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Preface 15
Safety instructions

! WARNING
Infectious materials
There is a potential risk of infection. Staff using the
cobas® Liat® Analyzer to perform tests on patient
samples must be aware that any object coming into
contact with biologic specimens is a potential source of
infection.
r Use lab gloves.
r Use a new disposable pipette (provided) for each
sample.
r Follow all health and safety regulations applicable to
your institution.

Laser transmission
Label Explanation
There is a danger of contact with
laser light or severe damage to the
eyes. Do not stare into the laser
transmitter.

y Laser transmitter cautionary labels

! WARNING
Blindness due to intense barcode reader light
The intense light of a laser barcode reader may severely
damage your eyes or result in exposure to hazardous
radiation.
r Do not stare into the beam of a laser barcode reader.
r Do not remove covers from barcode readers.
r Do not perform any maintenance actions on barcode
readers. If you experience problems with the barcode
readers, contact your Roche representative.
r Perform only the procedures described in operating
instructions. Performing unauthorized procedures may
result in exposure to hazardous radiation.

Barcode Wave Pulse Max. Remark


reader beam length duration output
localization
BC1 650 nm 720 μs 1.0 mW Class 2 laser
IEC 60825-1
BC1 CFR 21
Part 1040.10
y Laser barcode reader in the cobas® Liat® Analyzer

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
16 Preface
Safety instructions

! CAUTION
Electromagnetic interference
Malfunction of system and incorrect results due to
interfering electromagnetic fields
This system is designed and tested to CISPR 11 Class A
standard. In a domestic environment it may cause radio
interference, in which case, you may need to take
measures to mitigate the interference.
r The electromagnetic environment should be evaluated
prior to operation of the device.
r Do not operate this system in close proximity to
sources of strong electromagnetic fields (for example
unshielded intentional RF sources), as they may
interfere with proper operations.

Class A equipment is suitable for all use in all


establishments other than domestic and those directly
connected to a low voltage power supply network which
supplies buildings used for domestic purposes (CISPR 11,
4.2).

This instrument has been designed and tested to IEC


61326-2-6 and complies with the emission and immunity
requirements.

This system is designed and tested to CISPR 11 Class A


standard. In a domestic environment it may cause radio
interference, in which case, you may need to take
measures to mitigate the interference.

Disposal The analyzer must be disposed of in accordance with


relevant local regulations and in coordination with your
local authorities, as appropriate. Please note that the
analyzer may potentially be infectious. It should therefore
be decontaminated before disposal.

Labels on the analyzer

Biohazard warning
This label indicates that there are potential biohazards
within the vicinity of this label. The user is responsible
for cleaning the area if biohazardous material was
spilled. Follow Good Laboratory Practices for working
with biohazardous materials

General warning
Potential hazards located near this label may lead to
death or serious injury

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Installation 17
Installing the analyzer

Installation

Installing the analyzer


Place the analyzer on a suitable level surface and connect
it to the mains power supply. Connect it to a printer and a
network, if required.

When the analyzer is starting up, a series of initialization


diagnostic tests are performed automatically.

! CAUTION
Incorrect results or malfunctions due to incorrect
installation
Performing installation actions other than those
mentioned in this documentation may lead to malfunction
and incorrect results.
r Do not carry out any installation actions that are not
described in this documentation or for which you were
not appropriately trained.

! CAUTION
Injury by tripping over cables
Cables between the analyzer and wall outlets cause a
potential tripping hazard.
r Position the analyzer as close to the wall outlet as
possible, taking care to ensure sufficient room for
ventilation (at least 10 cm).
r Take care not to trip if you must walk behind the
analyzer.

! CAUTION
Power interruption
A power failure or momentary drop in voltage may
damage the system or lead to data loss.
r It is recommended to use an uninterruptible power
supply (UPS).
r Ensure periodic maintenance of the UPS.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
18 Installation
Installing the analyzer

NOTICE
Malfunction due to use of inappropriate power
supply
Using an inappropriate power supply may cause
malfunction.
r Only use the supplied power supply.

Make sure that the package includes the following items:


m cobas® Liat® Analyzer
m Universal Power Supply
m Power cable
m Touch screen stylus
m User ID Card Kit
m Administrator password card
m cobas® Liat® Advanced Tools Key
m cobas® Liat® Cleaning Tool Kit
m cobas® Liat® Analyzer Quick Start Guide

q If the packaging is damaged or an item is missing or


damaged, immediately contact your Roche
representative.

q Retain the shipping container and packaging


materials in the event that the analyzer needs to be
returned to Roche for service.

d m cobas® Liat® Analyzer


m Power supply
m Power cables
m Ethernet data cable, if you intend to connect the
analyzer to a data network
m USB cable, if you intend to connect the analyzer to a
USB printer

j m If the analyzer is cold due to shipping or storage, allow


it to come to room temperature before opening the
package and powering up to avoid possible
condensation inside the analyzer.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Installation 19
Installing the analyzer

r To install the analyzer

1 Place the analyzer on a level, vibration free, and non-


reflective surface, away from direct sunlight.
I Allow at least 10 cm (4 inches) of space at the rear
of the analyzer for airflow. Ensure vents are not
blocked.
Allow at least 6 cm (2.5 inches) of space in front of
the analyzer for easy barcode scanning.
Position the analyzer near a grounded outlet to
avoid creating a trip hazard with the power cable.

2
2 Connect the power supply with the analyzer.
I Only use voltage of 100-240 V AC, 50-60 Hz.

3 Connect the power supply to a properly grounded


mains outlet.

4
4 Press and release the power button to power on the
analyzer.

5 Connect the analyzer to the local data network, if


5
required.
I Use a standard Ethernet data cable and connect to
an appropriate wall connector or switch.

6 Log on to the analyzer.


I When you use a default user account for the first
time, you must change the password at logon.
When you log on to the analyzer for the first time
and you intend to connect a USB printer, make
sure this USB printer is not connected.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
20 Installation
Installing the analyzer

r To install a USB printer

1 When you start the analyzer for the first time, make
sure the USB printer is not connected.

2 Log on to the analyzer.


I You need Supervisor or Administrator access role.

3
3 Connect the printer to the analyzer.

4 Choose Main > Settings > System > Printer.

5
5 Choose the printer type and connection:
• For a laser printer, choose the PCL Laser item and
choose the LPT1: option.
• For an inkjet printer, choose the PCL Inkjet item
and choose the LPT1: option.

6
6 Choose the Select button. Choose the Printing
Mode item:
• For a grayscale printer, keep the default
Grayscale option.
• For a color printer, choose the Color option.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Installation 21
Installing the analyzer

r To install a network printer

1
1 Connect the analyzer to the local data network.
I Use a standard Ethernet data cable and connect to
an appropriate wall connector or switch.

2 Choose Main > Settings > System > Printer.


I You need Supervisor or Administrator access role.

3
3 Choose the printer type and connection:
• For a laser printer, choose the PCL Laser item and
choose the NET0: option.
• For an inkjet printer, choose the PCL Inkjet item
and choose the NET0: option.

4 Choose the Select button.

5
5 Enter Server Name, Share Name, User Name, and
Password settings.
I For information about the settings for the print
server, contact your network administrator.

6
6 Choose the Printing Mode item:
• For a grayscale printer, keep the default
Grayscale option.
• For a color printer, choose the Color option.

7 Return to the Main menu.


I If you do not return to the Main menu, settings will
be lost at the next restart of the analyzer.

u Related topics
• Logging on (29)
• Changing your password (31)
• System settings (79)

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
22 About the analyzer
About the analyzer functions

About the analyzer

About the analyzer functions


The analyzer and the associated disposable assay tubes
are for in vitro diagnostic use. The analyzer identifies
and/or measures the presence of genetic material in a
biological sample. The analyzer automates all nucleic acid
test (NAT) processes, including reagent preparation,
target enrichment, inhibitor removal, nucleic acid
extraction, amplification, real-time detection, and result
interpretation in a rapid manner.

Overview The assay tube uses a flexible tube as a sample


processing vessel. It contains all assay reagents pre-
packed in tube segments separated by seals. Multiple
sample processing actuators in the analyzer compress
the assay tube to selectively release reagents, move the
sample from one segment to another, and control
reaction conditions. A detection module monitors the
reaction in real-time, while an on-board computer
analyzes the collected data and outputs an interpreted
result.

In a typical assay, a raw sample is first mixed with an


internal control and then with lysis reagents. Magnetic
glass particles are incubated with the lysed sample for
nucleic acid enrichment, and are then captured and
washed to remove possible inhibitors. Subsequently,
nucleic acid is eluted from the magnetic glass particles
and transferred alternately between tube segments at
different temperatures for rapid PCR amplification and
real-time detection.

Insert and test automation The cobas® Liat® System automates all testing
processes from sample preparation to amplification and
real-time detection. By reducing complex nucleic acid
testing to three simple steps, cobas® Liat® technology
enables non-specialized personnel to conduct
sophisticated testing.

When the sample is added to the sample segment of the


assay tube, the tube is capped and remains closed for the
entire test process. No further materials need to be added
or removed from the tube. This approach avoids cross-
contamination, reduces biohazard risks, and helps
preserve sample integrity.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
About the analyzer 23
About the analyzer functions

Rapid testing This technology uniquely uses liquid flow and mixing to
enhance reaction rates while allowing for relatively large
reaction volumes. For example, the cobas® Influenza A/B
Nucleic Acid Test for use on the cobas® Liat® System,
using a nasopharyngeal swab sample, takes
approximately 20 minutes from sample collection to result
generation.

q Assay tubes can only be used once.

NOTICE
Damage to the analyzer due to using unauthorized
assay tubes
The use of unauthorized or unapproved assay tubes or
accessories may damage the analyzer. Damage caused
by unauthorized tubes or accessories voids the analyzer
warranty.
r Only use assay tubes listed in the standard supplies
table in this publication.

Self-checks When the analyzer is starting up, a series of initialization


diagnostic tests are performed automatically.
Furthermore, the analyzer monitors its operations during
assay processing, and performs an automated calibration
periodically. If an error occurs, a message is displayed on
the screen and the event is logged.

Running assays The testing process has been condensed to a few simple
steps:
• Preparing a patient sample.
• Transferring the sample into an assay tube.
• Scanning the assay tube barcode label.
• Inserting the assay tube into the analyzer.
• The analyzer automatically runs all the required assay
steps and reports the test results.
• Disposing of the assay tube.
• Reviewing the result.

q Before using the analyzer for the first time, make


sure it is set up correctly and the required assays are
installed and activated.

About the audit trail The system logs each user action that triggers a system
change in an audit trail entry together with user
information and time stamp.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
24 About the analyzer
Overview of the analyzer operating elements

You can export the audit trail using the advanced tools
key.
u For information on exporting the audit trail, refer to the
cobas® Liat® Advanced Tools Key Guide.

u Related topics
• Setting up the analyzer (60)
• Installing or updating assays from a USB key (62)
• Installing or updating an assay from the Roche remote
service platform (64)
• Installing an assay from a local source (66)
• Adding an assay tube lot (70)

Overview of the analyzer operating elements

A
F
B

C G

A Function buttons D Tube entry door G Power button


B Navigation buttons E Touch screen
C Barcode reader F Power indicator light

w Analyzer components.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
About the analyzer 25
About assays

Function buttons The function buttons are located beneath the touch
screen and are aligned with the touch screen buttons.

You press a button to perform the same function as


touching the aligned button on the touch screen.

Navigation buttons You use the 4 buttons (left, right, up, and down) to
highlight an item for selection, scroll through menus,
position the cursors, and toggle selections.

Barcode reader The barcode reader aims the scanning beam down in
front of the analyzer. Choosing the Scan button activates
the reader for approximately 5 seconds to read barcodes.

Tube entry door Opens and closes automatically during an assay run so
that you can insert and remove the assay tube.

q Never open or close the tube entry door manually,


unless instructed to do so on the screen.

Touch screen You touch the items on the screen with your finger (also
when wearing lab gloves), or the stylus included with the
analyzer.

Power button Switch on and switch off the analyzer.

About assays
The analyzer runs a specific assay as determined by the
scanned barcode of an assay tube.

The analyzer requires a program, called an assay script, to


conduct a specific assay.

New assays can be added to the assay menu by installing


assay scripts. You need Supervisor or Administrator
access role to install an assay script.

The currently installed assays are listed on the Assay


Menu panel.

u Related topics
• Installing an assay from a local source (66)
• Adding an assay tube lot (70)
• Running an assay (46)

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
26 About the analyzer
Overview of the touch screen

Overview of the touch screen


To operate the touch screen, use your finger (even when
wearing lab gloves) or the stylus included with the
analyzer.

NOTICE
Damage to the touch screen due to using sharp
objects
Using sharp objects on the touch screen may damage the
screen and lead to malfunction.
r Do not use sharp objects for operating the touch
screen.

Touch screen elements


The touch screen is divided into several information and
operating areas.

A
B

A Title bar D Function buttons


B Subtitle bar E Navigation buttons
C Touch screen buttons F Scroll bar

w Overview of touch screen.

q To choose an item, either touch it directly or use the


corresponding function button.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
About the analyzer 27
Overview of the touch screen

Title bar Displays


• User access role icon:

User

Supervisor

Administrator
• Current main menu or assay name, including
indication whether the share lot function is enabled
(SL).
• User ID
Note that user IDs shown in screenshots in this
publication are for illustration purposes only.
• Possibly alert icon:

Warning

Service
• In case of a configured DMS or HL7 connection,
connectivity monitor icon:

So far, there has been no connection or there was an


error during the last connection.

Last connection was successful.

Connection currently transmitting.

q To display information on the meaning of an icon,


touch it.

Touch screen buttons The touch screen buttons vary depending on the current
content of the screen.

Function buttons Perform the same function as the corresponding touch


screen buttons.

Navigation buttons Use to highlight an item for selection, scroll through


menus, position the cursors, and toggle selections.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
28 Common user actions
Starting the analyzer

Common user actions

In this section
Starting the analyzer (28)
Logging on (29)
Changing your password (31)
Assigning or changing your badge barcode (34)
Selecting items on the screen (36)
Selecting predefined values (36)
Entering text and numbers (37)
Scanning barcodes (37)
About locking the analyzer (39)
Locking the analyzer manually (41)
Unlocking the analyzer (42)
Switching off the analyzer (44)

Starting the analyzer


Switching on the analyzer starts an initialization process
that ensures the proper functioning of the analyzer.

NOTICE
Damage to the analyzer due to inappropriate
handling
Inserting an assay tube into the analyzer prior to
completion of initialization results in damage to the tube,
possible damage to the analyzer and failure of the assay
tube to provide a result.
r Do not insert assay tubes or any other object into the
tube chamber while it is starting up.

n Up to several minutes

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Common user actions 29
Logging on

r To start the analyzer

1
1 Press the power button.
I If the temperature inside the analyzer is low, the
analyzer warms up until the internal temperature
reaches the threshold temperature. This may take
some time.
f Power indicator lights up
f Touch screen lights up
f Tube entry door opens and closes
f Actuators inside the analyzer move
f Self-checks are performed

2
2 Wait until the login panel is displayed.
I Initialization may take several minutes.

Logging on
At logon, the analyzer prompts you for your user ID and
password, for your badge barcode and password, or for
your badge barcode only.

A user ID barcode is a barcode representing your user ID.


A badge barcode can be any barcode that complies with
the system standards.

The type of authentication prompted at logon depends on


the authentication mode setting on the analyzer.

q Independent of the authentication mode setting on


the analyzer, you can always log on with your user ID and
password.

u For details on entering information, see Entering text


and numbers (37).
u Scanning barcodes (37)
u About authentication modes (80)

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
30 Common user actions
Logging on

r To log on with user ID

1
1 On the login panel, choose the Login button.

2
2 To enter your user ID, do one of the following:
• Enter your user ID manually and choose the OK
button.
• Place your user ID barcode parallel to the analyzer
directly beneath the barcode reader. Choose the
Scan button.

3
3 Enter your password and choose the OK button.
f In the title bar of the Main menu, your access role
and user ID are indicated.

r To log on with badge barcode

1
1 On the login panel, choose the Login button.
I If a badge barcode authentication mode is set on
the analyzer, the barcode reader is enabled
automatically.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Common user actions 31
Changing your password

2
2 Scan your badge barcode.
I If you want to log on with your user ID instead, wait
until the time to scan your badge barcode runs out.
On the message dialog box, choose the Manual
button.

3
3 If required, enter your password and choose the OK
button.
f In the title bar of the Main menu, your user ID and
access role are indicated.

u Related topics
• Scanning barcodes (37)
• About authentication modes (80)

Changing your password


All users can change their own passwords.

If users are not exchanged with a connected DMS, you


can change your password at anytime.

q If users are exchanged with a connected DMS, users


can only change their passwords based on a request from
the DMS.
u About data exchange with a DMS (86)

When prompted by the analyzer, you must change your


password at logon. By default, new users have to change
their passwords at first logon.

q When you use a default user account for the first


time, you must change the password at logon.
u To change your password at logon p (33)

u About user IDs and passwords (91)


u Resetting the lost default administrator
password (125)

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
32 Common user actions
Changing your password

Changing the password of another user Users with Supervisor or Administrator access role can do
the following:
• Change the password of another user up to their own
access role.
• Request a password change at next logon for another
user up to their own access role.

These changes work the same way as changing any other


item of a user information.
u Changing user information (94)

r To change your password at anytime

1 Choose Settings > User.


I If you are logged on with User access role, only
your own user account is listed.

2
2 Choose the Info button.

3
3 Choose the Password item.
I If you are logged on with User access role, you
have access to the Password item and the Badge
Barcode item only.

4
4 Enter your current password and choose the OK
button.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Common user actions 33
Changing your password

5
5 Enter your new password and choose the OK button.
I For passwords, you can use alphanumeric
characters, symbols and/or spaces.
Passwords are restricted in length to 4–20
characters.

6
6 To confirm your new password, enter the password
again and choose the OK button.
f Your password is changed.

r To change your password at logon

1
1 When prompted to change your password, choose the
OK button.

2
2 Enter your new password and choose the OK button.
I For passwords, you can use alphanumeric
characters, symbols and/or spaces.
Passwords are restricted in length to 4–20
characters.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
34 Common user actions
Assigning or changing your badge barcode

3
3 To confirm your new password, enter the password
again and choose the OK button.
f Your password is changed.

Assigning or changing your badge barcode


All users can assign and change their own badge
barcodes.

If users are not exchanged with a connected DMS, you


can assign or change your badge barcode at anytime.

q If users are exchanged with a connected DMS, users


cannot assign or change their badge barcodes directly on
the analyzer.
u About data exchange with a DMS (86)

Changing the badge barcode of another user Users with Supervisor or Administrator access role can
assign or change the badge barcodes of other users up to
their own access role.

Assigning or changing the badge barcodes of another


user works the same way as changing any other item of a
user information.
u Changing user information (94)

r To assign or change your badge


barcode
1 Choose Settings > User.
I If you are logged on with User access role, only
your own user account is listed.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Common user actions 35
Assigning or changing your badge barcode

2
2 Choose the Info button.

3
3 Choose the Badge Barcode item and choose the
Change button.
I If you are logged on with User access role, you
have access to the Password item and the Badge
Barcode item only.

4
4 To assign a badge barcode, scan your badge barcode
twice.

5
5 To change your badge barcode, do one of the
following:
• To remove an assigned badge barcode, choose the
Remove button.
• To replace your badge barcode, choose the
Replace button. Scan your badge barcode twice.

u Related topics
• Scanning barcodes (37)

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
36 Common user actions
Selecting items on the screen

Selecting items on the screen

r To select an item using the buttons

1
1 Use the and navigation buttons to select
the desired item.
I Alternatively, you can touch the item on the
screen.

2
2 Choose the Select button.
f This may lead to detailed information on the
selected item or to a new panel. It may also
confirm an action.

Selecting predefined values


Some items can take one of several predefined values.

Values that can be chosen are framed by green arrows,


when selected.

r To select a predefined value

1 Select the item you want to change.

2
2 Use the Left and Right navigation buttons to
select the desired value.
I The value that can be chosen is displayed between
green arrows, for example .

3 Choose the Change button.

4 Choose the Done or OK button, whichever is


available.

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cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Common user actions 37
Entering text and numbers

Entering text and numbers


Depending on the situation, either the alphanumeric or
the numeric keyboard is displayed.

Key Function
ABC Enter capital letters.
abc Enter lower case letters.
123 Switch to number/symbol entry.
abc Switch to letter entry.
ABC
g Delete the character to the left of the cursor.
y Selected keys on the alphanumeric keyboard

To confirm the entry, choose the OK button.

Key Function
CLR Delete the character to the left of the cursor.
Caps Switch to letter entry.
Symb Switch to symbol entry.
Enter Confirm the entry and close the numeric keyboard.
y Selected keys on the numeric keyboard

To confirm the entry, choose the Enter button of the Next


button.

Scanning barcodes
You use the barcode reader for scanning assay tube,
sample, package insert, control, user ID, and badge
barcodes.

q To maintain patient confidentiality and privacy


standards, do not use protected health information (e.g.;
patient name, social security number) as the sample ID.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
38 Common user actions
Scanning barcodes

The sample ID barcode must comply with one of the


following standards:
• Code 39
• Code 93
• Code 128
• Codabar
• GS1 Databar-14

Roche recommendations for visible inspection of printed


barcodes:
• The printing should be of good contrast (dark black
on white background).
• The background should be solid white (no
transparency, no patterns, no color), non-reflecting
material.
• Check for sharp edges and clear lines of the barcode
bars (no fringed lines).
• Quiet zone of the barcode must be respected (white
space on the left/right of the bars).
• When scratching on the barcodes with the fingers or
fingernails, the printing should hold and not smear
even not if body oil, disinfection or other fluids are
used, watch out for wrinkles.

All specimen barcodes should be printed to achieve


ISO/IEC 15416 Grade 2.5 - 4.0 (formerly ANSI X3, 182 -
1990 Grade A or B) to ensure reliable barcode reading.

r To scan an assay tube barcode

1
1 Choose the Scan button.

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cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Common user actions 39
About locking the analyzer

1
2
2
2 NOTICE Placing the barcode inappropriately may lead
to reading errors or malfunction.
2 Place the barcode parallel to the analyzer directly
beneath the barcode reader and make sure the
scanner light extends beyond the barcode on both
sides.

3 If for some reason, the barcode cannot be read, try


again.

4
4 If the barcode still cannot be read, choose the Enter
button and enter the barcode text manually.

About locking the analyzer


Locking the analyzer ensures that it is secured when
inactive or left unattended.

Locking the analyzer The analyzer locks automatically or you can lock it
manually. In each case, the walk-by panel is displayed.

w Walk-by panel.

The auto-lock function locks the analyzer automatically


after a predetermined period of inactivity called the auto-
lock time. You define the auto-lock time in Settings
> System > Auto-Lock Time. It must be set to a value
between 1–10 minutes. The default value is 3 minutes.

You lock the analyzer manually by choosing the user icon


in the top left corner of a panel.

q Locking the analyzer manually is not possible when


a message box is displayed or when a process is running
(e.g. running an assay).

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
40 Common user actions
About locking the analyzer

Unlocking the analyzer When your account is locked, unlock it by entering your
password or by scanning your badge barcode. You are
returned to the panel in which you were working when
the analyzer locked.

Logging on to use the analyzer When another user’s account is locked, you must log on
to use the analyzer. If the previous user has unsaved data,
it is lost when you log on.

Auto-lock and assay runs During an assay run, the auto-lock function is suspended
until the sample preparation, amplification, and detection
have completed. It is not possible to lock the analyzer
manually until the assay run is finished.

A message is displayed when the assay tube can be


removed from the analyzer. The auto-lock function starts
again at this point.

w Remove the assay tube.

If the assay tube remains in the analyzer for longer than


the auto-lock time, the analyzer locks and the walk-by
panel is displayed.

To log on and use the analyzer when a tube is inserted,


you must first remove the assay tube.

w Remove the assay tube and log on.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Common user actions 41
Locking the analyzer manually

A red flashing message at the top of the panel indicates


that the assay run completion is in progress. The assay
run finishes a short time after the assay tube is removed
and you can log on.

If you try to log on before the assay run finishes, the


system indicates that it is busy.

w System is busy while assay run finishes.

Clear the message and log on.

u Related topics
• Locking the analyzer manually (41)
• System settings (79)
• Unlocking the analyzer (42)
• Logging on (29)
• Running an assay (46)

Locking the analyzer manually


Lock the analyzer to secure it when you leave it
unattended.

You can lock the analyzer manually at any time with the
following exceptions:
• When a message box is displayed.
• When a process is running (e.g. an assay run).

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
42 Common user actions
Unlocking the analyzer

r To lock the analyzer manually

1
1 In the top left corner of the panel, choose the user
icon.
f The walk-by panel is displayed.

u Related topics
• Unlocking the analyzer (42)

Unlocking the analyzer


The walk-by panel is displayed when the analyzer is
locked.

If you were logged on when the analyzer locked, you must


unlock it to continue working.

If another user was logged on when the analyzer locked,


you must log on to use it.

The procedures are explained in this task.


u To unlock the analyzer by entering your
password p (42)
u To unlock the analyzer by logging on as another
user p (43)

j m The walk-by panel is displayed.

r To unlock the analyzer by entering


your password

1
1 On the walk-by panel, choose the Unlock button.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Common user actions 43
Unlocking the analyzer

2
2 Enter your password and then choose the OK button.
f You are returned to the panel in which you were
working when the analyzer locked.

r To unlock the analyzer by scanning


your badge barcode

1
1 On the walk-by panel, choose the Unlock button.
I If the Barcode & Password authentication mode
or the Barcode authentication mode is set on the
analyzer, the barcode reader is enabled
automatically.

2
2 Scan your badge barcode.
f You are returned to the panel in which you were
working when the analyzer locked.

r To unlock the analyzer by logging on


as another user

1
1 On the walk-by panel, choose the Login button.
f A warning message is displayed.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
44 Common user actions
Switching off the analyzer

2
2 To continue and log on, choose the Yes button.
I Choosing the No button, returns you to the walk-
by panel.

3 Follow the normal logon procedure (u 29).

u Related topics
• About locking the analyzer (39)
• Locking the analyzer manually (41)

Switching off the analyzer


Switching off the analyzer shuts down the software and
turns off the power.

! CAUTION
Loss of power
r Do not turn power off while the analyzer is running an
assay.
r In the event of power loss while an assay is running,
do not attempt to remove the assay tube.
When power is restored, power on the analyzer and
only remove the assay tube when the message
“Please remove the tube slowly and carefully” is
displayed.

j m There is no activity on the analyzer.

r To switch off the analyzer

1
1 Press and hold the power button until both the power
indicator light and the touch screen turn dark.

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cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Performing a run 45
Switching off the analyzer

Performing a run
Safety u Make sure you are familiar with the safety instructions
in Safety instructions (14).

! CAUTION
Incorrect results due to using inappropriate assay
tubes
Using non certified assay tubes may lead to incorrect
results.
r Only use cobas® Liat® Assay Tubes.
r Never reuse assay tubes.

! CAUTION
Incorrect results or malfunction due to
inappropriate handling of assay tubes
Inappropriate handling of assay tubes may lead to
incorrect results or malfunction.
r Do not remove or insert an assay tube while the
analyzer is performing an assay.
r Always use the barcode of the assay tube sleeve that
belongs to the assay tube that you are using.
r Do not break any seals of the assay tube. Take
particular care when adding sample.
r Do not force or rotate the assay tube when inserting it.
r Do not reuse spent assay tubes.

NOTICE
Malfunction due to inappropriate handling of the
analyzer
Inappropriate handling of the analyzer may lead to
malfunction.
r Do not manually open or handle the tube entry door,
unless instructed to do so on the screen.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
46 Performing a run
Running an assay

Running an assay
The analyzer runs a specific assay as determined by the
scanned barcode of an assay tube.

Running an assay comprises the following actions:


• Transferring sample into an assay tube and capping
the tube.
• Scanning the assay tube and sample ID barcodes.
- To maintain patient confidentiality and privacy
standards, do not use protected health information
(e.g.; patient name, social security number) as the
sample ID.
- If you must enter the sample ID manually, do not
use spaces.
• Inserting the assay tube into the analyzer.
• The analyzer performs the required assay steps and
reports the test results.

q For information on transferring sample into the


assay tube, see the instructions in the package insert or
the instructions for use for the assay you are running.

q Make sure you use the correct sample type as


indicated on the screen.

q The auto-lock function is suspended during an


assay run. It starts again when the message asking you to
remove the assay tube is displayed.
u About locking the analyzer (39)

d m Assay tube
m Disposable pipette supplied with the assay tube
m Sample ID barcode

r To run an assay

1 Tear open the foil packaging of the assay tube.


I Follow the instructions in the package insert or the
instructions for use of the assay.
Make sure not to break the first seal at the top of
the assay tube.
Do not remove the protective sleeve until you
insert the assay tube in the analyzer.

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Performing a run 47
Running an assay

2 Check the assay tube for possible damage, for


example for leaks or broken seals.

3
3 On the Main menu, select the Run Assay option and
choose the Select button.

4
4 Choose the Scan button.

5
5 Scan the assay tube barcode.
I Do not remove the assay tube sleeve.

6
6 Choose the Scan button again and then scan the
sample ID barcode.
I If necessary, you can enter the sample ID
manually. No spaces should be used when you
enter the values.

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cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
48 Performing a run
Running an assay

7 Transfer the correct type of sample:


7
• Use the sample type indicated on the screen.
• Decap the assay tube.
• Transfer sample into the assay tube.
• Recap the assay tube.
I Do not remove the assay tube sleeve.
Dispense the sample to the first seal at the top of
the assay tube without an air gap to prevent large
bubbles.
Do not break the first seal at the top of the assay
tube.

8 Dispose of all used disposable pipettes in accordance


with the disposal policy of your institution.

9
9 Choose the Scan button and scan the assay tube
barcode again.
I If by mistake you removed the assay tube sleeve
completely, make sure that the serial numbers and
the lot numbers on the assay tube and on the
sleeve match, before you scan the barcode.

10
10 Remove the assay tube sleeve and insert the assay
tube into the analyzer until the tube clicks into place.
I The assay tube only fits in one way.
f The tube entry door closes automatically and
processing begins.

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Performing a run 49
Aborting an assay run

11
11 Check the progress, if required.
I In the subtitle bar, a run number (for example
“R00056”) and the sample ID are displayed.
Choose the ViewData button to view messages or
to display the growth curve.
To abort the assay run, choose the Abort button.

12
12 When the assay run is complete, the tube entry door
opens. A message asks you to remove the assay tube.
Remove the assay tube and dispose of it in
accordance with the disposal policy of your institution.
f If configured, results will be sent to a host
automatically.

13
13 Do one of the following:
• To review the results, choose the Report button.
• To return to the Main menu - and for example to
start another assay - choose the Main button.
• To view the growth curve or messages, choose the
ViewData button.

u Related topics
• Reviewing results (53)
• About assays (25)
• Scanning barcodes (37)
• Aborting an assay run (49)

Aborting an assay run

r To abort an assay run

1
1 On the assay run status panel, choose the Abort
button.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
50 Performing a run
Aborting an assay run

2
2 On the confirmation message, choose the Yes button.

3
3 Enter your password and choose the OK button.
• Depending on the setting of the analyzer, scan
your badge barcode to abort the run.
I You can choose the Back button to return to the
previous panel.
f The analyzer stops assay processing.
f The analyzer writes a result report.

4
4 When asked to do so, remove the assay tube.

5 Dispose of the assay tube in accordance with the


disposal policy of your institution.

6
6 Do one of the following:
• To view the result report, choose the Report
button.
• To return to the Main panel, choose the Main
button.

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cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Performing a run 51
Result handling

Result handling
In this section
About results (52)
Reviewing results (53)
Exporting and deleting results (57)

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
52 Performing a run
Result handling

About results
The way results are calculated and displayed depends on
the intended use of each individual assay.

Result reports

Result report

Printed result report Growth curve

q If a run has the run status “Warning” (on the


message panel and in the result report), but the run did
not abort, the result of this run is still valid.

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cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Performing a run 53
Result handling

Reviewing results
Users with Supervisor or Administrator access role can
accept or reject results.

You typically review results as part of assay processing.


Alternatively, you can select results on the Results panel
and review them.

q If the analyzer is set up to send results automatically


to a host system, reviewing is not done on the analyzer.
u About data exchange with a DMS (86)

j m Logged on with Supervisor or Administrator access


role.

r To review results from the assay


status panel

1
1 From the assay status panel, you can do the following:
• Display the growth curve (see step 2).
• Display and print run status information (see step
3).
• Review and print the result report (see steps 4 to
9).
I You can perform these actions when the assay run
is complete.

2
2 To display the growth curve, on the assay status panel,
choose the ViewData button. Choose the Real-time
PCR option.
I From the graph panel, you can print the graph.
You can zoom into an area of the graph by
dragging a finger, or the stylus, across the area
into which you want to zoom.
To zoom out, touch the screen and from the drop-
down list that displays do one of the following.
Either, choose the Zoom Out option to zoom out
incrementally, or the Zoom Normal option to the
original magnification.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
54 Performing a run
Result handling

3
3 To display run status information, on the assay status
screen, choose the ViewData button. Choose the
Message option.
I From the message panel, you can print the
messages.

4
4 To view the result report, on the assay status panel,
choose the Report button.

5
5 On the Result Report panel, if the result information
does not fit into one screen, use the and
navigation buttons to display the rest of the
information.

6 From the Result Report panel, you can do the


following:
• Approve or reject the result (see steps 7 to 8).
• Print the result report (see step 9).

7 To approve or reject the result, on the Result Report


panel, choose the Approval button.

8
8 On the Approval message, choose the Release
button to accept the result or the Reject button to
reject it.
f On the result report, your user ID is added to the
Approved By line.

9
9 To print the result report, on the Result Report panel,
choose the Print button.
I If the analyzer is set up to print the results
automatically or to send the results automatically
to an information system or a POCT1-A interface,
this step is not required.

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Performing a run 55
Result handling

r To review results from the Results


panel
1 On the Main menu, select the Results option and
choose the Select button.
f A panel is displayed for selecting specific results.

2
2 Select the filter.
Use the and navigation buttons to select a
specific filter.
• All files
• Sample ID
• Assay
• User ID
• Calib
• Unreleased
• Needs Approval
• Export and delete results
I With filter options ending with a colon, you need to
enter a value, for example an ID or name.
Choose the Properties button to display the total
number of result reports, the space used so far
(Flat File), and the remaining space available.

3 Choose the Next button.

4
4 On the next filter panel, define the time period for
which the results should be included.
I Use the and navigation buttons to select
a specific period.
This week
All dates
Today
Last 2 days
Last month
MMDDYY-MMDDYY (you need to enter the two
dates)

5 Choose the OK button.

6
6 On the Results panel, select the desired result entry.
I + Positive
- Negative
? Indeterminate
! Invalid
@ Aborted
Approved
Rejected
Sent, but not yet confirmed by host
Sent to host successfully
Double-touch a column header to sort the table
according to this criterion.

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cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
56 Performing a run
Result handling

7 From the Results panel, you can do the following:


• Review and print the result report (see steps 8 to
14).
• Save the result in a specific location or send the
result to a host (see steps 15 to 17).

8 To review the result report, on the Results panel,


choose the View button.

9
9 On the Result Report panel, if the result information
does not fit into one screen, use the and
navigation buttons to display the rest of the
information.

10 From the Result Report panel, you can do the


following:
• Approve or reject the result (see steps 11 to 13).
• Print the result report (see step 14)

11 To approve or reject the result, on the Result Report


panel, choose the Approval button.

12
12 On the Approval message, choose the Release
button to accept the result or the Reject button to
reject it.

13 On the confirmation message, choose the Yes button.


f On the result report, your user ID is added to the
Approved By line.

14
14 To print the result report, on the Result Report panel,
choose the Print button.
I If the analyzer is set up to print the results
automatically or to send the results automatically
to an information system or a POCT1-A interface,
this step is not required.

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Performing a run 57
Result handling

15
15 To save the result report or to send it to a host, on the
Results panel, choose the File button. From the File
panel, you can do the following:
• Save the report in a specific location (see step 16).
• Send the report to a host (see step 17).

16 To save the report in a specific location, on the File


panel, choose the Save File option. Choose one of the
options and follow the instructions on the screen:
• USB Key
• Share Folder
• Service FTP
• LAN FTP

17 To send the result to a HIS, LIS, or a POCT1-A


interface, choose the Send option and follow the
instructions on the screen.

Exporting and deleting results


You can only delete a result after exporting it to a
different location. Once you have deleted a result, you
can no longer retrieve it from the analyzer.

Roche recommends to regularly back up all results. You


can use the advanced tools key for this purpose.

! CAUTION
Data security
Results backed up by the advanced tools key are stored
as plain text files and so their content is accessible to
unauthorized persons.
r Ensure that you store backed up results safely and
securely so that they are not accessible by
unauthorized persons.

u For information on backing up results, refer to the


cobas® Liat® Advanced Tools Key Guide.

j m Logged on with Supervisor or Administrator access


role.

r To export and delete a result

1 On the Main menu, select the Results option and


choose the Select button.
f A panel is displayed for selecting specific results.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
58 Performing a run
Result handling

2
2 Use the and navigation buttons to select
the Export and Delete Results option.

3 Choose the Next button.

4
4 On the next filter panel, define the kind of results you
want to delete.
Use the and navigation buttons to select a
specific criterion.
• Export and Delete all results
• Export and Delete results over 7 days old
• Export and Delete results over 30 days old
• Export and Delete results over 60 days old
• Export and Delete results over 90 days old
• Export and Delete results over 180 days old
• Export and Delete results over 365 days old
• Export and Delete results before MMDDYY
You must enter the required date, for example
“103115” to delete all results older than October
31, 2015.

5 Choose the OK button.

6
6 Choose the export location:
• USB Key
• Share Folder
• Service FTP
• LAN FTP

7 Choose the Select button.

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Performing a run 59
Result handling

8
8 If you use a USB key, insert the USB key at the rear of
the analyzer. Choose the OK button.

9
9 On the message dialog box, choose the Yes button to
confirm that this is the correct criterion and that you
want to export and delete all results that meet this
criterion.

10 Wait for the operation to complete and choose the OK


button to return to the Main menu.

u Related topics
• Network definitions (81)
• Network resources (81)

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
60 Setting up the analyzer
Defining values

Setting up the analyzer


Setup tasks are performed from the Settings panel.

q With Administrator access role, you can perform all


setup tasks, with Supervisor access role, you can perform
the setup tasks with the exception of the Network
definitions.

q Result and setup data are retained on the analyzer


even if it is not connected to a mains power supply.

In this section
Defining values (60)
Installing and updating assays (62)
Viewing and printing assay tube lot information (77)
Defining system settings (78)
Network definitions (81)
Network resources (81)
Connections to a host system (85)
Managing users (90)
Updating the software (97)
Registering the software (100)
Viewing software and hardware information (102)

Defining values
You define values by entering text or by selecting a
predefined value.

r To enter text

1
1 Use the and navigation buttons to select
the configuration item.

2 Choose the appropriate button, typically Select.

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Setting up the analyzer 61
Defining values

3
3 Use the and navigation buttons to select
the specific item that you want to define, and choose
the appropriate button, typically Enter.
f The alphanumeric keyboard or the numeric
keyboard is displayed.

4 Enter the value and to confirm choose the OK button.


f The panel is displayed again where you have made
the last item selection.
f If the text is not valid, a message informs you about
this fact.

r To select a predefined value

1 Use the and navigation buttons to select


the item you want to change.
I Items with predefined values are framed by green
arrows.

2
2 Use the Left and Right navigation buttons
to select the desired value.

3 Choose the Change button.

4
4 To save the setting, choose the Enter or OK button,
whichever is available.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
62 Setting up the analyzer
Installing and updating assays

Installing and updating assays


Before you can perform an assay, the assay must be
installed.

If the analyzer is set up to install and update from the


Roche remote service platform, a message is displayed
when a new assay or an update to an installed assay is
available.

To use a new assay, the following steps need to be


performed:
1. Installing the assay script
2. Adding the assay tube lot
3. Allowing users to perform runs using the new assay
(i.e., changing the user information)

q Do not disconnect the mains power supply to the


analyzer while installing or updating an assay.

In this section
Installing or updating assays from a USB key (62)
Installing or updating an assay from the Roche remote
service platform (64)
Installing an assay from a local source (66)
Registering assays (68)
Adding an assay tube lot (70)
Deleting assay tube lots (74)
Uninstalling assays (76)

Installing or updating assays from a USB key


Before you can perform an assay you must install it. You
update an assay when changes are available for this
assay.

q It is recommended to use the USB key as the


preferred method for installing and updating assays.

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Setting up the analyzer 63
Installing and updating assays

If you are logged on with User or Supervisor access role,


a message is displayed asking you to inform your system
administrator.

After an assay update, you may need to revalidate the


assay lots that are in use.

j m Logged on with Administrator access role.

r To install or update an assay from a


USB key

1
1 While on the Main menu, insert the USB key at the
rear of the analyzer.

2 2 On the message dialog box, choose the OK button.

3
3 Enter your password and choose the OK button.

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Installing and updating assays

4
4 Choose the Yes button to confirm that you want to
install or update the listed assays.
f A progress panel is displayed. All available assays
or updates are installed.

5 Follow the dialog box: “Please remove the USB drive,


wait 5 seconds and hit <OK> to continue.”
f The script installation or update completes. This
process can take several minutes.

6
6 Do one of the following:
• When a message indicating a successful
installation or update is displayed, choose the OK
button to confirm.
You can check the new assay in the Assay Menu
panel.
You can check the updated assay script version by
choosing Settings > Versions.
• When a message indicating an unsuccessful
update is displayed, choose the OK button to
return to the Main menu.
You should repeat steps 1 to 5.

7
7 If assay revalidation is required, a message is
displayed.
• Choose the Display button to display a list of
assays that need to be revalidated.
• Choose the OK button to return to the Main menu.

8 You may need to register the assay manually.

u Related topics
• Installing or updating an assay from the Roche remote
service platform (64)
• Adding an assay tube lot (70)
• Registering assays (68)

Installing or updating an assay from the Roche remote service platform


Before you can perform an assay you must install it. You
can install it from the Roche remote service platform.

When a new assay or an assay update becomes available,


a message is displayed on the analyzer screen during
logon.

If you are logged on with User access role, a message is


displayed asking you to inform your supervisor or system
administrator.

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Setting up the analyzer 65
Installing and updating assays

To be able to use a new or updated assay, the following


steps need to be executed:
1. Installing or updating the assay
2. Validating the assay tube lot
With an update, this step is not always required, a
message would inform you if validation was required.
3. Allowing users to perform runs using the new assay
(i.e., changing the user information)

d m Your IT infrastructure is set up to allow


communication with Roche remote service (IP:
62.209.44.11)

j m Logged on with Supervisor or Administrator access


role for installation, with Administrator for update.
m The analyzer is connected to the internet.

r To install or update an assay from the


Roche remote service platform

1
1 When a new assay or an update to an assay is
available, a message is displayed on the analyzer
screen during logon.

2 On the message dialog box, choose the OK button.

3
3 Enter your password and choose the OK button.

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66 Setting up the analyzer
Installing and updating assays

4
4 On the message dialog box, choose the Yes button.
f A progress panel is displayed.

5
5 When the installation is complete, a message is
displayed. Choose the OK button.

6 If assay validation is required, a message is displayed.


6
• Choose the Display button to display a list of
assays that need to be validated.
• Choose the OK button to return to the Main menu.

7 You may need to register the assay manually.

u Related topics
• Adding an assay tube lot (70)
• Registering assays (68)

Installing an assay from a local source


You can install an assay from a USB key, an FTP server, or
a share folder in your network.

You would typically want to do this when Roche deploys


new assays.
u Defining network resources (82)

j m If you install from a network server, make sure the


assay script is stored in the appropriate location and
the network settings are configured correctly.
m Logged on with Administrator or Supervisor access
role.

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Setting up the analyzer 67
Installing and updating assays

r To install an assay from a local


source

1
1 On the Main menu, select the Assay Menu option
and choose the Select button.
f All currently installed assays are listed.

2
2 Choose the [New Assay] option.
I You may have to scroll down to display this option.

3
3 Choose Scan.

4 Within the time limit for inserting tubes, place the


barcode from the assay package insert or the
instructions for use under the barcode reader.
f The Download software from: field becomes
available.

5
5 Define where to download the software from.
• Select USB Key if you install from a USB key.
• If you have defined a different install source
setting, choose the appropriate option.

6 If you use a USB key, ensure the signed ZIP file of the
assay to be installed is in the root folder of USB key.

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68 Setting up the analyzer
Installing and updating assays

7
7 If you use a USB key, insert the USB key at the rear of
the analyzer.

8 Choose the Next button.

9 If you installed from a USB key, remove the USB key


from the rear of the analyzer when asked to do so.

10
10 Decide whether you want to validate (add an assay
tube lot) this assay now or later.

11 You may need to register the assay manually.

u Related topics
• Adding an assay tube lot (70)
• Registering assays (68)
• System settings (79)
• Defining network resources (82)

Registering assays
New and updated assays must be registered within 30
days.

You can use the unregistered assays during the


registration period. But once this period has expired, the
assay can no longer be used for testing until the
activation has been completed.

q If the analyzer is connected to the Roche remote


service platform, the analyzer automatically tries to
register. If this fails, a message is displayed and a user
must register the assay manually.

j m Logged on with Administrator access role.

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Installing and updating assays

r To register an assay manually

1 Start the registration process.


1
• If a message is displayed, choose the Activate
button.
• If no message is displayed, in the Main menu,
choose the Assay Menu option.

2
2 Select the assay that needs registering and choose
the Select button.
I Unregistered assays are marked with a number in
the Days left column.
A red icon at the end of an entry indicates that
the registration period has expired.

3
3 On the Report panel, choose the Activate button.

4
4 From the message dialog box, note the registration
code.

5 Call your Roche representative and provide the


registration code.

6 The Roche representative issues an activation code.

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Installing and updating assays

7
7 On the message dialog box, choose the OK button.

8
8 Enter the activation code and choose the OK button.

9
9 On the message dialog box, choose the OK button.

Adding an assay tube lot


Assay tube lots have a certain shelf life. Each new assay
tube lot has to be added on the analyzer and is validated
by running a negative and positive control.

Adding an assay tube lot includes the following activities:


1. Scanning the new lot data
2. Performing QC (validating the assay tube lot)

Sharing assay tube lots Instead of adding and validating the same assay tube lot
on several analyzers, you can share assay tube lots
between analyzers in the following ways:
• By synchronizing the assay tube lots using the
advanced tools key.
• By using the share lot function over the share lot
folder.
• By connecting the analyzers to a DMS and enabling
the exchange of lots.

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Installing and updating assays

q Do not use different ways to share assay tube lots at


the same time.

u For information on the advanced tools key, see the


cobas® Liat® Advanced Tools Key Guide.
u For information on using the share lot function, refer
to Defining network resources (82)
u For information on the connection to a DMS, refer to
Defining settings for host systems (85)

c • Before using the first assay tube of a new lot.


• When revalidation of an assay tube lot is necessary.

d m Assay tube from the new lot


m Package insert or instruction for use of the assay tube
lot for the specific assay
m Disposable pipette

j m Assay installed

r To add a new assay tube lot

1
1 On the Main menu, select the Assay Menu option
and choose the Select button.

2 Select the [New Lot] option and choose the Select


2
button.
• Assay: 4-letter name of the installed assays
• Lot#: Validated assay tube lot numbers
• Validated: Date of validation
• Expiration: Date the lot is set to expire
• Days left: Days left for activation of the assay

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Installing and updating assays

3
3 Obtain the package insert or the instructions for use
from the new lot. Choose the Scan button and scan
the package insert barcode on the first page of the
package insert or the instructions for use of the lot
you want to add.

4 You may need to confirm that you have read the


package insert.

5
5 Choose the Scan button and place the barcode of the
negative control under the barcode reader.

6
6 Follow the instructions in the assay tube package
insert or the instructions for use on how to add the
negative control sample to an assay tube from this lot.

7 Dispose of all used disposable pipettes in accordance


with the disposal policy of your institution.

8 Choose the Scan button.

9
9 Place the prepared assay tube under the barcode
reader.

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Installing and updating assays

10
10 Within the time limit for inserting assay tubes, insert
the prepared assay tube in the analyzer.
f Processing starts automatically.

11 Wait for a message to inform you that the negative


control result has been accepted. Choose the OK
button to confirm the message.
I If the QC was not completed successfully, repeat
the measurement of the negative control.

12 When asked to do so, remove the assay tube from the


analyzer and dispose of it in accordance with the
disposal policy of your institution.

13
13 Wait until the information in the title bar stops
flashing, then choose the Back button.

14
14 Choose the Scan button and place the barcode of the
positive control under the barcode reader.

15
15 Follow the instructions in the assay tube package
insert or the instructions for use on how to add the
positive control sample to an assay tube from this lot.

16 Dispose of all used disposable pipettes in accordance


with the disposal policy of your institution.

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Installing and updating assays

17
17 Choose the Scan button.

18 Place the prepared assay tube under the barcode


reader.

19
19 Within the time limit for inserting assay tubes, insert
the prepared assay tube in the analyzer.
f Processing starts automatically.

20 Wait for a message to inform you that the positive


control result has been accepted. Choose the OK
button to confirm the message.
I If the QC was not completed successfully, repeat
the measurement of the positive control.
Check the Instructions for Use of the control for
further information.

21
21 When asked to do so, remove the assay tube from the
analyzer and dispose of it in accordance with the
disposal policy of your institution.

22
22 Wait until the information in the title bar stops
flashing, then choose the Back button.

23
23 Check the entry for the new assay tube lot.

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Installing and updating assays

Deleting assay tube lots


If you delete the assay tube lot, you cannot run the
associated assay anymore, unless there is another
validated assay tube lot for this assay or the deleted assay
tube lot is added and revalidated again.

q If assay tube lots are exchanged with a DMS, you


cannot delete assay tube lots on the analyzer.
u About data exchange with a DMS (86)

j m Logged on with Supervisor or Administrator access


role

r To delete an assay tube lot

1 On the Main menu, select Assay Menu and choose


the Select button.

2
2 Select the assay tube lot entry.

3 Choose the Delete button.

4
4 On the confirmation message dialog box, choose the
OK button.
f The lot entry NA on the Assay Menu panel
indicates that there are no validated lots for this
assay.

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76 Setting up the analyzer
Installing and updating assays

Uninstalling assays
Uninstalling an assay removes the assay script from the
analyzer.

q Roche does not recommend to uninstall assays.

j m Logged on with Administrator access role.

r To uninstall an assay

1 On the Main menu, select Assay Menu and choose


the Select button.

2
2 Select the assay entry.
I If there are validated assay tube lots for the assay,
there may be several entries for this assay.

3 If there are assay tube lots for the assay you want to
uninstall, delete them all first.
• Select the assay tube lot entry.
• Choose the Delete button.
I When all assay tube lots are deleted, there is only
one entry left for the assay and the value in the
Lot# column is NA.

4 Choose the Delete button.

5
5 On the confirmation message dialog box, choose the
Yes button.

6 Enter your password and choose the OK button.

u Related topics
• Deleting assay tube lots (74)

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Viewing and printing assay tube lot information

Viewing and printing assay tube lot information


You can view and print the details of all added assay tube
lots.

r To view and print assay tube lots

1
1 On the Main menu, select the Assay Menu option
and choose the Select button.

2
2 To print the list of installed assays and assay lots,
choose the Print button.
f The list of installed assays and assay lots is sent to
the printer.

r To view and print control test results


of a lot

1
1 On the Main menu, select the Assay Menu option
and choose the Select button.

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Defining system settings

2
2 Select the assay tube lot you are interested in and
choose the Select button.

3
3 On the report panel for the control, do either of the
following:
• To print the results, choose the Print button.
• To display the report panel of other controls,
choose the Next button.
(Choose the Previous button to display the
previous report panel again.)

4 To return to the assay tube lot list, choose the Back


button.

Defining system settings


Define the general operating environment.

In this section
System settings (79)
About authentication modes (80)

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cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
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Defining system settings

System settings
To define the general operating environment, enter the
required information.
f Settings > System

q For your records, you can print the system settings


using the Print button.

System item Configuration item Comment


Time & Date Time & Date Time format: hh:mm:ss
Date format: mm-dd-yyyy
SNTP Choose Yes to have date and time automatically updated from
a server.
If you choose Yes, you need to define the server.
Do not manually change the time and date when SNTP is on.
Server IP address or DNS name of the SNTP server from which time
and date are obtained. This server can be any workstation in
the network or any remote SNTP server.
Brightness Screen brightness. 1 = darkest, 7 = brightest.
Printer Use a standard PCL compatible printer. (PCL 3 GUI is not
supported.)
LPT1 Choose for a USB printer. No further configuration is required.
NET0 Choose for a network printer.
Choose the Select button and then enter the required printer
information:
o Server Name
Name of the print server.
o Share Name
Name of the share.
o User Name
User name of the analyzer specific account on the print
server.
o Password
Password of the analyzer specific account on the print
server.
Printing Mode Keep the default Grayscale, if a grayscale printer is
connected.
Choose Color, if a color printer is connected.
Auto Print Choose Yes to automatically print the results as soon as assay
processing is finished.
Sound Initialization, Barcode Choose Off to turn off the acoustic signal for the selected
Scan, Tube Insert, Assay event.
Aborted, Touch Screen, Choose any of the available signal types to define that an
Key Clicks acoustic signal should be sounded at the end of the selected
event.
Volume Choose a value between 0 (off) to 5 (loudest).
The volume setting applies to all acoustic signals.
Tube Insert Time Value between 1 and 20 Maximum time in seconds allowed for inserting the assay tube
seconds after scanning its barcode.
Defining a short time ensures that the assay tube is inserted
that was just scanned, and it reduces the likelihood of
contamination of the reaction chamber.
y System configuration items

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80 Setting up the analyzer
Defining system settings

System item Configuration item Comment


Name of Machine Up to 15 alphanumeric By default, this is the analyzer serial number.
characters.
Tilt Sensing Enable If the analyzer is tilted by ten or more degrees, the current
assay is stopped.
Roche recommends to have this feature enabled.
Language You cannot currently choose this option.
Auto-Lock Time Value between 1 and 10 Time in minutes after which the auto-lock function is activated.
minutes. Default time is 3 minutes.
Default Settings Choosing the Select button resets all values defined from the
Settings panel to the factory values, with the exception of the
Time & Date and Name of Machine values.
Authentication User ID & Password, Choose the authentication mode for logging on to the analyzer.
Barcode & Password, or
Barcode
q Consider the level of security provided by the
different authentication modes.

y System configuration items

About authentication modes


The authentication mode determines the logon method.

You can choose between the following authentication


modes:
• User ID & Password:
To logon to the analyzer, you must enter your user ID
and password. Instead of manually entering your user
ID, you can scan a corresponding user ID barcode (a
barcode representing your user ID).
• Barcode & Password:
To logon to the analyzer, you must scan your assigned
badge barcode and enter your password.
• Barcode:
To logon to the analyzer, you must scan your assigned
badge barcode only.
This authentication mode provides the lowest level of
security.

q Independent of the set authentication mode, you


can always logon with your user ID and password.

u Related topics
• Logging on (29)
• Managing users (90)

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Network definitions

Network definitions
Define the network environment.
f Settings > Network

! CAUTION
Breach of confidentiality and privacy
Unprotected network connections may allow access by
unauthorized persons and confidential personal
information may be obtained.
r When connecting the analyzer to a network make sure
the connection is secure and monitored for security
breaches.
r If parts of your network, which the analyzer uses to
exchange data, are connected by WLAN, make sure to
use WPA2 encryption.

You can connect the analyzer to a 10/100 Ethernet


network.

q oThe Liat is not ping-able.


o For detailed information on how to set up
communication between the analyzer and a host
system, contact your Roche representative.

Network item Configuration item Comment


DHCP Yes When choosing Yes, the network definitions are automatically
obtained from your DHCP server.
No When choosing No, you can select the other configuration
items and enter the appropriate values.
IP Address Define the IP address.
Subnet Mask Define the subnet mask.
Gateway Define the IP address of the gateway server.
DNS Server Define the name of the DNS server.
y Network configuration items

Network resources
You can define network resources for installing and
updating assays, and for sharing assay tube lots. These
resources can also be used for backing up results.

In this section
Defining network resources (82)
Using the share lot function (83)

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
82 Setting up the analyzer
Network resources

Defining network resources


To define the network resources, enter the required
information.
f Settings > Install Source

Before you can define network resources, obtain the


following information:
m Share name (full path if you intend to use FTP)
m Server name (IP address if you intend to use FTP)
m User name and password for the specific account

You can define one of the following options.


(Note that you can only use IP addresses for FTP servers.
Share servers use IP addresses and host names).

Network resource item Configuration item Comment


Share Folder Used for installing new assays and saving results.
Server Name URI of the Share folder server.
Share Name Name of the share.
User Name User name of the analyzer specific account on server.
Password Password of the analyzer specific account on server.
Service FTP Used for installing new assays and saving results.
Server IP IP address of the Service FTP server.
Folder Path Enter the full path using the syntax of the server.
User Name User name of the analyzer specific account on server.
Password Password of the analyzer specific account on server.
LAN FTP Used for installing new assays and saving results.
Server IP IP address of the LAN FTP server.
Folder Path Enter the full path using the syntax of the server
User Name User name of the analyzer specific account on server.
Password Password of the analyzer specific account on server.
Share Lot Folder Used for sharing assay tube lots.

q Instead of adding the same assay tube lot on


several analyzers, use share lots.

Server name URI of the Share Lot server.


Share Name Name of the share.
User Name User name of the analyzer specific account on server.
Password Password of the analyzer specific account on server.
Use Share Lot o To enable the share lot function, choose the Yes option.
o To disable the share lot function again, choose the No
option.
y Network resource configuration items

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Setting up the analyzer 83
Network resources

q With some items, the Sample button is available


when they are selected. Choosing Sample displays a
valid example for the value you should enter.

q If you are using Windows Server 2008 or above for


Share Lot or network printing, do the following:
o Choose the Group policy editor option, and then
choose Local Computer Policy > Computer
Configuration > Windows Settings > Security
Settings > Local Policies > Security Options.
o Choose the Network security: LAN Manager
authentication level option and set the value to
Send LM & NTLM. Use NTLMv2 session security
if negotiated.
o Ensure that the share lot folder is configured to allow
read and write privileges for the appropriate user
account.

Using the share lot function


The share lot function allows you to share assay tube lots
between analyzers.

Depending on your setup, you can use one of the


following ways to share assay tube lots:
• The advanced tools key
• The share lot function
• The exchange of lots with a DMS

q Do not use different ways to share assay tube lots at


the same time.

u Sharing assay tube lots (70)

j m Logged on with Administrator access role.

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cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
84 Setting up the analyzer
Network resources

r To enable the share lot function

1
1 Choose Settings > Install Source > Share Lot
Folder.
• Choose the Server Name, Share Name, User
Name, and Password items and enter the
required information.
• Choose the Use Share Lot item and choose the
Yes option.

2 Restart the analyzer. Log on with Administrator access


role.
f In the title bar, (SL) is displayed next to the Main
menu.

3 Choose Settings > Install Source > Share Lot


Folder and review the installed assays and available
assay tube lots.

r To disable the share lot function

1
1 Choose Settings > Install Source > Share Lot
Folder. Choose the Use Share Lot item and choose
the No option.

2 Restart the analyzer. Log on with Administrator access


role.
f In the title bar, (SL) is no longer displayed next to
the Main menu.

3
3 Choose the Assay Menu option. Review the installed
assays and assay tube lots.
I You must revalidate assay tube lots that were
validated previously while the share lot function
was enabled.

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Connections to a host system

Connections to a host system


To set up data exchange, connect the analyzer to a host
system.

In this section
Defining settings for host systems (85)
About data exchange with a DMS (86)
Connecting the analyzer to a DMS (88)

Defining settings for host systems


To define the connection to a LIS, HIS, or DMS, enter the
required information.
f Settings > Connectivity

q For detailed information on how to set up


communication between the analyzer and a host system,
contact your Roche representative.

HIS/LIS item Configuration item Comment


Type None Choose to set the analyzer to standalone mode.
POCT1-A (LIS) Choose to connect to a HIS or LIS.
POCT1-A (DML) Choose if you use a POCT1-A DML interface.
Server Host IP address or the host name (for example “HLSPC”).
FQNAME (for example host.customer.net) is not supported.
Port
q For information about the host address and port,
contact your network administrator.

Timeout Timeout (in seconds) for receiving the acknowledgment from


the host.
TLS encryption Choose Yes to secure the communication between the
analyzer and the HIS, LIS, or DMS.

q Unsecured communication may result in


unauthorized access and misuse. Roche recommends to
always enable TLS encryption.

Configure secure Enter the certificate for the TLS encryption.


communication
y Connectivity configuration items

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cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
86 Setting up the analyzer
Connections to a host system

HIS/LIS item Configuration item Comment


Auto Send results Choose to send results automatically to the host computer as
soon as they are generated.

q Automatically sent results that were received by the


host cannot be resent manually.

Data Synchronization o Auto Send Choose which data is exchanged with a connected DMS.
o Users
o Assay Lots
o Device Configuration q Enabled data synchronization affects analyzer
o Log Events functions, e.g. the local deletion of assay tube lots or
local user management.
u About data exchange with a DMS (86)

Conn. Interval Time between data synchronizations.


y Connectivity configuration items

About disconnecting an analyzer To disconnect an analyzer and to set it into standalone


mode, choose Settings > Connectivity > Type and
choose the None option.

q If you want to reconnect the analyzer later, take note


of the settings before disconnecting it.

About data exchange with a DMS


The connection to a data management system (DMS) and
enabled data synchronization influences the functionality
of the analyzer.

If the analyzer is connected to a DMS and data


synchronization is enabled, the following functions of the
analyzer are affected:
• Automatic locking
• Results review
• Lot management
• User management
• Changing your password
• Changing your badge barcode
• Analyzer settings / device configuration
• Event logs

Contact your local DMS administrator for tasks that are


disabled on the analyzer.

Changes in the DMS are only effective on the analyzer


after a completed data synchronization.

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Connections to a host system

About automatic locking Some data received from the DMS (e.g. user data and
assay tube lots) can only be applied while the analyzer is
locked or no user is logged on. While such data is
received and applied, you cannot unlock the analyzer.
u About locking the analyzer (39)

About results review If the analyzer sends results automatically to a DMS or


HL7 host, you cannot review results on the analyzer.
u Reviewing results (53)

About lot management You can share assay tube lots between analyzers, if the
exchange of lots is enabled.

If assay tube lots are exchanged with the DMS, you


cannot delete assay tube lots on the analyzer.
u Sharing assay tube lots (70)
u Deleting assay tube lots (74)

About user management If the analyzer exchanges user data with a DMS, user
management is disabled on the analyzer.

q To enable access to the analyzer, the user IDs and


passwords defined on the DMS must only consist of
ASCII Printable Characters (32-126) without #96
(‘ character).

u Managing users (90)

About changing your own password If the analyzer exchanges user data with a DMS, users
can only change their passwords based on a request from
the DMS.

When requested by the DMS, you must change your


password at logon.

q To prevent logon problems, make sure the rules for


passwords on the analyzer and the DMS match.

u Changing your password (31)

About changing your own badge barcode If the analyzer exchanges user data with a DMS, users
cannot assign or change their badge barcodes directly on
the analyzer.
u Assigning or changing your badge barcode (34)

About analyzer settings If the analyzer accepts system settings from the DMS, the
received settings override local settings. Local changes of
the settings are only effective as long they are not
overwritten from the DMS.

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88 Setting up the analyzer
Connections to a host system

Network settings cannot be overwritten from the DMS.


u System settings (79)

About event logs If configured, the analyzer sends events to the connected
DMS.
u Viewing and printing the event log (124)

Connecting the analyzer to a DMS


To connect the analyzer to a DMS, follow the procedure
below.

j m Logged on with Administrator access role.

r To connect the analyzer to a DMS

1
1 Choose Settings > Connectivity. Choose the Type
item and choose the POCT1-A (DML) option.

2
2 Choose the Server Details item:
• Enter Server, Port, and Timeout settings.
• Set the TLS encryption item to the Yes option.
• Configure secure communication.
I For details, refer to the cobas® Liat® Analyzer
Host Interface Manual POCT1-A (DML) or contact
your Roche representative.

3 To return to the Connectivity panel, choose the


Done button.

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Setting up the analyzer 89
Connections to a host system

4
4 Choose the Data Synchronization item. If you want
the analyzer to exchange data with the DMS, choose
the corresponding item and set it to the Yes option.

5 To return to the Connectivity panel, choose the


Done button.

6 Choose the Conn. Interval option and enter the time


between data exchanges. Choose the Save button.

7 Restart the analyzer.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
90 Setting up the analyzer
Managing users

Managing users
You can add new users, change user information, and
delete complete user accounts.

Make sure each user has an own user account on the


analyzer. Do not use shared user accounts.

q If the analyzer exchanges user data with a DMS,


user management is disabled on the analyzer.
u About data exchange with a DMS (86)

In this section
Overview of user account access roles (90)
About user IDs and passwords (91)
Defining new users (91)
Changing user information (94)
Deleting a user account (95)

Overview of user account access roles


The access role defines which actions a user can perform
on the analyzer.

Icon Access role Permitted actions


User Run authorized assays and view
assay tube lots. Change own
password and badge barcode.
Supervisor As user, plus: review results,
manage users (with access role
Supervisor or User), set up the
analyzer (except network
settings), manage assay tube lots,
install assays.
Administrator As Supervisor, plus: network
configuration settings, manage all
users, update assays and
software, register assays and
software.
y Access roles

q When the analyzer is delivered to the customer,


default user accounts are provided.

q Note that the user IDs shown in screenshots in this


publication are for illustration purposes only. The user ID
does not necessarily reflect the user’s access role.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Setting up the analyzer 91
Managing users

About user IDs and passwords


On the analyzer, user IDs and passwords are restricted in
length and/or allowed characters.

For user IDs, the following rules apply:


• The user ID is case insensitive.
• The length of a user ID must be between 1 and 20
characters.
To avoid cut-off user IDs in the title bar, it is
recommended to define short user IDs.
• The user ID must not contain any white spaces.

For passwords, the following rules apply:


• For passwords, alphanumeric characters, symbols,
and/or spaces are allowed.
• The length of a password must be between 4 and 20
characters.

About user management on a DMS If the analyzer exchanges user data with a DMS, the
following rules apply additionally:
• Make sure the rules for user IDs and passwords on
the analyzer and the DMS match.
• User IDs and passwords defined on the DMS must
only consist of ASCII Printable Characters (32-126)
without #96 (‘ character).
u About data exchange with a DMS (86)

Defining new users


User accounts control access to the analyzer and
determine which functions you can perform on the
analyzer, including the assays the user can perform.

If your access role is Supervisor, you can define users of


the User and Supervisor access role.

If your access role is Administrator, you can manage


users of the Administrator, Supervisor, and User access
role.

j m Logged on with Supervisor or Administrator access


role.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
92 Setting up the analyzer
Managing users

r To define a new user

1
1 To display the User panel, do one of the following:
• On the Main menu, choose the User button.
• Choose Settings > User.
f The User panel lists all defined users. The icon
preceding the user ID indicates the user access
role.

2
2 Choose the [New User] option.

3 Choose the Add button.

4
4 To define a user detail, select the item and choose the
Enter button. Then do either of the following:
• Enter the information and choose the OK button.
• Select the option and choose the Select button.
I To avoid cut-off user IDs in the title bar, it is
recommended to define short user IDs.

5
5 If the analyzer is configured for a badge barcode
authentication mode, assign and scan the badge
barcode:
• In the User Info panel, choose the Badge
Barcode item. Choose the Enter button.
• Select the Assigned option.
• Scan the badge barcode twice.
I New users cannot assign their badge barcodes at
logon. This is only possible when a user is logged
on.

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Setting up the analyzer 93
Managing users

6
6 To define which assays the user can perform, do the
following:
• Select the Allowed Assay: option and choose the
Enter button.
• On the Allowed Assay panel, select the assay you
want the user to be able to perform. Choose the
All button if you want to select all listed assays.
• Choose the Change button. The values of the
selected assays change from blank (not allowed)
to Allowed or vice versa.
• To keep the changes, choose the Done button.

7
7 On the User Info panel, choose the Add button to
save the definitions.
I By default, new users must change their
passwords on first logon.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
94 Setting up the analyzer
Managing users

Changing user information


User accounts control access to the analyzer and
determine which functions you can perform on the
analyzer, including the assays the user can perform.

If your access role is User, you can change your own


password and badge barcode.

If your access role is Supervisor, you can change user


information of the User and Supervisor access role.

If your access role is Administrator, you can change user


information of the Administrator, Supervisor, and User
access role.

About locking user accounts To prevent a user from logging on, lock the user account.
To allow access to the analyzer again, unlock the user
account.

Locking and unlocking user accounts is part of changing


the user information. You cannot lock your own account.

q You cannot lock the default Administrator account.

j m Logged on with User, Supervisor, or Administrator


access role.

r To change user information

1
1 To display the User panel, do one of the following:
• On the Main menu, choose the User button.
• Choose Settings > User.

2
2 Select a user entry.
I If you are logged on with Administrator or
Supervisor access role, all currently defined users
of the same access role or lower are listed.
If you are logged on with User access role, your
own user account is listed only.
The icon preceding the user ID indicates the user
access role.

3 Choose the Info button.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Setting up the analyzer 95
Managing users

4
4 To lock a user, select the Locked item. Select the Yes
option and choose the OK button.
I Locked users cannot log on to the analyzer.
To unlock a user, change the Locked item to the
No option.

5
5 To change a user detail, select the item and choose
the Change button. Then do either of the following:
• Enter the information and choose the OK button.
• Select the option and choose the Select button.
I If you set the Change PW item to the On next
login option, the user must change the password
when logging on the next time.

6 Proceed in the same way as when defining a new


user.

u Related topics
• Defining new users (91)
• Changing your password (31)

Deleting a user account


User accounts control access to the analyzer and
determine which functions you can perform on the
analyzer, including the assays the user can perform.

If your access role is Administrator or Supervisor, you can


delete users of your own level and below.

q Deleting a user does not affect results.

j m Logged on with Supervisor or Administrator access


role.

r To delete a user account


1 Choose Settings > User.

2 Select the user entry using the and


navigation buttons.

3 Choose the Delete button.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
96 Setting up the analyzer
Managing users

4 On the message dialog box, choose the Yes button to


confirm the deletion.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Setting up the analyzer 97
Updating the software

Updating the software


As part of further product development, Roche may issue
updates to the analyzer software remotely or via USB key.

q If you are logged on with User or Supervisor access


role and a message is displayed informing you that a
software update is available, inform your system
administrator.

About migration of user information During an upgrade of the analyzer software from version
3.0 to version 3.1, data is migrated. For user information,
the following migration rules apply:
• User IDs are no longer case-sensitive. Therefore, if 2
user IDs differ only in capitalization (e.g., user1 and
USER1), the newer user account will be deleted. The
older user account will be locked.
• If a user ID is longer than 20 characters, the user ID
will be truncated and the user account locked.
• If a user ID contains spaces, the spaced are removed
and the user account is locked.
• The default Admin account is migrated properly and is
not locked.

j m If you update from the Roche remote service platform,


the analyzer must be connected to a network and the
internet.
Firewall is set up to allow communication with
Host: remoteservice.roche.com
IP: 62.209.44.11
Port: 443
Protocol: TCP / SSL
m Logged on with Administrator security rights.

r To update the software from the


Roche remote service platform

1
1 CAUTION! Do not disconnect the mains power supply
to the analyzer while updating software.
1 When a software update is available, a message is
displayed on the analyzer screen.

2 On the message dialog box, choose the Yes button.

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cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
98 Setting up the analyzer
Updating the software

3
3 Enter your password and then choose the OK button.
f The analyzer checks the available storage space
on the analyzer. If there is not enough storage
space, a message is displayed and you must make
storage space available by deleting either lots or
results.

4
4 On the Upgrade panel, when asked to do so, choose
the Reboot button.
I After successful restart, the analyzer attempts to
register the software automatically.

5 If automatic registration fails, you must register the


software manually.

r To update the software from a USB


key

1
1 CAUTION! Do not disconnect the mains power supply
to the analyzer while updating software.
1 While on the Main menu, insert the USB key at the
rear of the analyzer.

2
2 On the message dialog box, choose the OK button.

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Setting up the analyzer 99
Updating the software

3
3 Enter your password and choose the OK button.
f The analyzer checks the available storage space
on the analyzer. If there is not enough storage
space, a message is displayed and you must make
storage space available by deleting either lots or
results.

4
4 On the message dialog box, choose the Yes button.

5 Follow the dialog box: “Please remove the USB drive,


wait 5 seconds and hit <OK> to continue.”
f The software upgrade completes. This process can
take several minutes.

6
6 Do one of the following:
• When a message indicating a successful upgrade
is displayed, choose the Reboot button and wait
until the analyzer has restarted.
• When a message indicating an unsuccessful
upgrade is displayed, choose the OK button to
return to the Main menu.
Reboot the analyzer and repeat steps 1 to 6.

7 If a message indicating a config data mismatch is


displayed, do the following:
• On the Init/Get System State Status dialog box,
choose the OK button.
• On the Config Data Mismatch dialog box,
choose the Yes button.
• On the Message dialog box, choose the Reboot
button.

8 After successful restart you are prompted to calibrate


the screen by following the on-screen instructions.

9 Log on to the analyzer.


I The analyzer attempts to register the software
automatically.
If automatic registration fails, you must register the
software manually.
You can check the version of the updated software
by choosing Main > Settings > Versions.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
100 Setting up the analyzer
Registering the software

u Related topics
• Registering the software (100)
• Exporting and deleting results (57)
• Deleting assay tube lots (74)

Registering the software


Updated software must be registered within 30 days.

You can use the unregistered software during the


registration period, but once this period has expired, the
analyzer is locked for testing.

q If the analyzer is connected to the Roche remote


service platform, the analyzer automatically tries to
register. If this fails, a message is displayed and a user
must register the software manually.

j m Logged on with Administrator access role.

r To register the software manually

1
1 Start the registration process.
• If a message is displayed, choose the Activate
button.
• If no message is displayed, on the Main menu,
choose Settings > System Info.

2
2 From the System Info panel, note the registration
code.

3 Call your Roche Support and provide the registration


code.

4 The Roche Support issues an activation code.

5 On the System Info panel, choose the Activate


button.
Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Setting up the analyzer 101
Registering the software

6
6 Enter the activation code and choose the OK button.

7
7 On the message dialog box, choose the OK button.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
102 Setting up the analyzer
Viewing software and hardware information

Viewing software and hardware information


For troubleshooting reasons, it may be necessary to
check versions and IDs of the installed hardware and
software elements.

In this section
Viewing information about the analyzer and
software (102)
Viewing system information (103)

Viewing information about the analyzer and software


For troubleshooting or other reasons, you may be asked
to provide information about the analyzer and installed
software.

You access information about the analyzer by choosing


Settings > About Device, and then selecting one of the
options on the menu.

Menu options Comment


Versions For troubleshooting, you may be
asked to check the versions of the
installed software components and
assays.

Copyright Copyright information about


analyzer and software, including
trademark information.

y About Device menu options

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Setting up the analyzer 103
Viewing software and hardware information

Menu options Comment


Intended Use The intended use of the software
and the analyzer.

Open Source Information about open source and


commercial software.

Manufacturing Information Manufacturing-related information


about the analyzer.

y About Device menu options

Viewing system information


When installing or updating the software or for
troubleshooting reasons, you may need to know the IDs
of your analyzer and its installation or activation dates.
f Settings > System Info

Version and ID item Comment


Serial # Defined by Roche.
MAC Address Network interface card defined by manufacturer of main
board.
Service Due Date Date for service reminder, Roche recommends that the
analyzer be returned for service every 5 years.
Last Installation Date of last software installation/update.
yyyy-mm-dd
Registration code Software registration code needed for software activation
(This information is only displayed if the currently installed
software has not been activated.)
Activation date Date when the software was activated.
y System elements

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
104 Quality control

Quality control
Internal control Internal Process Control (IPC) is included in every assay
tube. It verifies the adequate processing of the biological
sample. The IPC passes, if sample purification and target
amplification meet validated acceptance criteria.

Quality control kits Quality control kits for each cobas® Liat® Assay are
available from Roche. The quality control kits contain
positive and negative control sample materials. The
process of running positive and negative controls is
similar to that for adding lots.
u See Adding an assay tube lot (70) and refer to the
cobas® Liat® Assay package insert or the
instructions for use for detailed instructions.

NOTICE
Additional QC testing
Additional QC testing is not required by the manufacturer.
Quality control should be run as a patient sample if
additional quality control testing is performed at a site.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Maintenance and calibration 105
About self-check

Maintenance and calibration


An operator is not required to perform any maintenance,
other than touch screen calibration.

In this section
About self-check (105)
About auto monitoring (105)
About auto adjustment (106)
About service (106)
Calibrating the touch screen (107)
Cleaning the analyzer (107)

About self-check
The analyzer performs self-diagnostics during startup
(initialization) and utilizes an advanced error diagnostics
system to monitor the analyzer’s performance during an
assay. Under normal operation, the analyzer alerts the
operator in the event that a malfunction or error is
detected.

The analyzer requires no adjustment or calibration from


the operator.

About auto monitoring


There is an automatic daily restart programmed for 3 AM
local time (once your settings have been updated), which
helps to maintain the health of your analyzer.

The analyzer has a built-in auto monitoring system to


ensure that it is functioning optimally at all times. During
monitoring you may see informational messages
displayed.

Choose the No button to start the restart process. Choose


the Yes button to effect a 60-second delay. After 60
seconds, another notification will appear and allow for a
final opportunity to delay for an additional 60 seconds
before automatically restarting the analyzer. Follow the
on-screen instructions, and the analyzer will restart.

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106 Maintenance and calibration
About auto adjustment

About auto adjustment


The analyzer periodically performs automatic adjustment.
During auto adjustment, AutoCal is displayed on the title
bar. If you choose the Run Assay option at this time, the
message “AutoCal started. This could take up to a
minute.” is displayed. Select the OK button to close this
message. Wait until AutoCal is no longer displayed in
title bar.

About service
Please contact your local Roche representative if you
have questions regarding the analyzer, its service needs,
or if you have other questions.

! CAUTION
Electrical hazards
Only a qualified Roche representative can service the
analyzer.
Disassembling the analyzer could result in electrical
hazards.
r Never attempt to repair or adjust the analyzer yourself.
r Contact your local Roche representative if the analyzer
fails to operate properly.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Maintenance and calibration 107
Calibrating the touch screen

Calibrating the touch screen


If you find that the analyzer activates a different item to
the one you just touched, calibrate the touch screen.

j m Logged on with Supervisor or Administrator access


role.

r To calibrate the touch screen

1 Choose Tools > Calibration > Touch Screen.

2
2 Choose the Select button.

3 Follow the instructions on the screen.

4 When calibration is complete, touch the screen to


confirm the new settings or wait 30 seconds to discard
the change.

Cleaning the analyzer


• Keep the touch screen clean from excessive
fingerprints and moisture by gently wiping it with a
soft, lint-free cloth.
• The exterior of the analyzer and front buttons can also
be cleaned using a soft lint-free cloth moistened with
either 70% isopropanol or 5-10% bleach solution. If
bleach is used, it must be wiped twice using 70%
isopropanol to remove all bleach residues.
• Periodically check the rear vent and bottom of the
analyzer for excessive dust or debris.
• When prompted by the message “Use cleaning tool”
on the screen, use the provided cleaning tool
following the instructions included with the cleaning
tool kit.

Safety u Make sure you are familiar with the safety instructions
in Safety instructions (14).

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
108 Maintenance and calibration
Cleaning the analyzer

! CAUTION
Electric shock
Spraying or applying liquid to the analyzer or the power
supply may damage the analyzer or pose an electrical
hazard.
r Do not spray or apply liquid directly on the analyzer or
the power supply.
r Do not attempt to clean the interior of analyzer
through the vents.
r To clean the tube chamber, only use the cobas®
Liat® Cleaning Tool when prompted by the analyzer.

NOTICE
Damage to the analyzer due to use of unsuitable
cleaning materials
Using unsuitable cleaning materials can damage the
touch screen and other surfaces.
r Only use the supplied cleaning tool when prompted
by the message. Do not attempt to clean the tube
chamber of the analyzer with anything other than the
cleaning tool kit.
r Do not use harsh, abrasive cleaners or wipes.

In this section
Cleaning the outside of the analyzer (109)
Cleaning spillages or leakages from an assay tube (110)

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Maintenance and calibration 109
Cleaning the analyzer

Cleaning the outside of the analyzer


Keeping the analyzer clean prevents contamination and
ensures trouble-free operation.

j m Soft lint-free cloth


m 70% isopropanol or 5-10% bleach solution

r To clean the touch screen

1
1 Wipe the touch screen gently with a soft lint-free
cloth.

r To clean the front buttons and the


exterior of the analyzer

1
1 Moisten a lint-free cloth with either 70% isopropanol
or 5-10% bleach solution.

2 Gently wipe the surfaces as required.

3 If you used bleach solution, wipe the affected areas


twice with a fresh lint-free cloth moistened with 70%
isopropanol to remove all bleach residues.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
110 Maintenance and calibration
Cleaning the analyzer

Cleaning spillages or leakages from an assay tube


In the unlikely event of a spillage or leak of an assay tube,
special precautions apply, because the tube contains
various potentially biohazardous materials and hazardous
chemicals.

! CAUTION
Contamination of cleaning tool
Do not use the cleaning tool for biohazardous
contamination. The cleaning tool does not decontaminate
the analyzer, but becomes contaminated itself.
r In case of spillages or leakages from an assay tube
follow the procedure below.

r To deal with a leak from an assay


tube
1 Dispose of the assay tube in accordance with the
disposal policy of your institution.

2 If the leak happened inside the analyzer, stop using


the analyzer and immediately contact your Roche
representative for further instructions.

3 Follow laboratory best practices.


• Follow Good Laboratory Practices for working with
biohazardous materials and hazardous chemicals.
• Refer to the appropriate assay tube Safety Data
Sheet and package insert or the instructions for
use for assay specific information.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Troubleshooting 111
List of error messages

Troubleshooting
The analyzer monitors its operation and logs abnormal
events. Based on the severity, the analyzer tries to recover
or to fix the error while running. If the situation cannot be
resolved, the analyzer stops.

In many situations, error messages are displayed on the


screen. Read them carefully and follow the instructions
provided in them.

Roche support If you have any questions or problems, contact your


Roche representative with the following analyzer
information ready:
m Analyzer serial number. You find this on the product
label at the back of the analyzer.
m Assay name
m Run number
m Error message and code (if displayed)
m Maintenance contract number (as applicable)
m System diagnostic information, using the Diagnostic
Backup function of the advanced tools key

For Roche Support in the U.S., call the following number:


1-800-800-5973.

In this section
List of error messages (111)
Generating a backup for troubleshooting purposes (124)
Viewing and printing the event log (124)
Resetting the lost default administrator password (125)
Cleaning the window of the barcode reader (127)
Resolving a tube entry door error before the start of a
run (128)
Resending results manually (128)
Restarting an unresponsive analyzer (129)

List of error messages


Error messages are generated in exceptional situations.
They describe the issue and provide information on how
to resolve the situation.

Software error codes and error messages Software error codes for the cobas® Liat® Analyzer
are displayed in hexadecimal system, in the range from
“0xb01” to “0xbff”, or numbered as “Error 1” to “Error 10”.

Error messages are without codes.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
112 Troubleshooting
List of error messages

q Issues identified by a unique hexadecimal code are


often recovered or fixed by the analyzer after restart. For
some error codes, additional actions are listed in the
following table. If the error persists after these actions,
copy the error code and contact Roche Service.

Code Message Action


0xb01 Print failed! Please contact the administrator to Check the printer settings and connection. For
resolve the problem. Code:(0xb01) a network printer, contact your local network
administrator. If this error continues, call Roche
Service.
0xb02 Your clock seems to be incorrect. The barcode Adjust the analyzer’s date and time so it’s
indicates the manufacture date YYYY-MM-DD accurate.
is in the future. Please correct your time. The date format is: year-month-day.
Code:(0xb02)
0xb03 Negative Control Result Rejected. Follow QC Kit Follow QC Kit insert instructions to prepare
Insert instructions to prepare NEGATIVE negative control and try again.
Control sample and try again. Code:(0xb03)
0xb05 Positive Control Result Rejected. Follow QC Kit Follow QC Kit insert instructions to prepare
Insert instructions to prepare POSITIVE Control positive control and try again.
sample and try again. Code:(0xb05)
0xb06 Invalid barcode: [ErrorCode] Code:(0xb06) See the information on barcode scanning in
this publication. Choose Scan and try again.
0xb07 This tube does not match the assay/lot in Step See the information on running an assay in this
1. Please check the tube and try again. publication. The assay tube barcode is scanned
Code:(0xb07) twice.
0xb08 Not a tube barcode Code:(0xb08) Scan the tube barcode.
0xb09 This tube has already been used! You must use An assay tube cannot be reused. Choose OK
a new tube. Code:(0xb09) and use a new tube.
0xb0a Print failed! Please contact the administrator to Check the print settings and cable connections
resolve the problem. Code:(0xb0a) and try again. If this error continues, restart the
analyzer. If error still continues, call Roche
Service.
0xb0b LiatLots.xml file is old format or it is corrupted Call Roche Service.
Code:(0xb0b)
0xb0c Liat Analyzer is not initialized, Add Lot not Call Roche Service.
allowed. Code:(0xb0c)
0xb0d Negative control process successful, but failed Call Roche Service.
to add lot to list Code:(0xb0d)
0xb0e Positive control process successful, but failed Call Roche Service.
to add lot to list Code:(0xb0e)
0xb0f Negative Control Result Rejected. Contact 1. Make sure the QC Kit is not expired.
Roche Service or follow QC Kit Insert 2. Follow QC Kit insert instructions to prepare
instructions to prepare NEGATIVE Control negative control and try again.
sample and try again. Code: (0xb0f) 3. If negative control still fails, call Roche
Service.
0xb10 Positive Control Result Rejected. Contact 1. Make sure the QC Kit is not expired.
Roche Service or follow QC Kit Insert 2. Follow QC Kit insert instructions to prepare
instructions to prepare POSITIVE Control positive control. Make sure the sample was
sample and try again. Code: (0xb10) mixed and the time period elapsed, then try
again.
3. Call Roche Service.
0xb11 InstalledPackages.xml file is corrupted Code: Choose OK and call Roche Service.
(0xb11)
y List of error messages

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Troubleshooting 113
List of error messages

Code Message Action


0xb20 More than 500 results found. Use filters to limit Use filters to limit your search results or
your search results. Code:(0xb20) perform export and delete results to reduce the
number of results.
0xb21 Graph data file was not found! Code:(0xb21) Issue with assay result. Call Roche Service.
0xb22 Invalid datapoints in file. Code:(0xb22) Issue with assay result. Call Roche Service.
0xb23 Graph data file is Invalid/corrupted! Issue with assay result. Call Roche Service.
Code:(0xb23)
0xb24 Unable to update the approval status Issue with assay result. Call Roche Service.
Code:(0xb24)
0xb30 Script file is missing. Call Roche Service: [full Choose OK and try again. If error continues,
path of the script file] Code:(0xb30) call Roche Service.
0xb31 \" + sampleIDText + \"" + " is not a valid Choose OK and enter or scan the sample ID
sample ID. Sample ID cannot be a Liat Tube or again.
Insert barcode or be empty. Please try again.
Code:(0xb31)
0xb32 Script has no battery power warning setting. Issue with assay script file. Call Roche Service.
Run not allowed. Code:(0xb32)
0xb33 Incorrect power warning setting, check your Issue with assay script file. Call Roche Service.
script. Code: (0xb33)
0xb34 Invalid Runtime in Script File, Abort! Choose OK and try again. If error continues,
Code:(0xb34) call Roche Service.
0xb35 No tube has been inserted! Code:(0xb35) Ensure you have fully inserted the tube. Choose
OK and try again. If error continues call Roche
Service.
0xb36 Assay aborted. Tube in place was found, but Ensure you have fully inserted the tube. Choose
lost after about a second. Code:(0xb36) OK and try again. If error continues call Roche
Service.
0xb37 Actuators not opened. Try reboot Code:(0xb37) Restart the analyzer. If error continues, call
Roche Service.
0xb38 Illegal script file selected Code:(0xb38) Issue with assay run. Call Roche Service.
0xb39 Script Manager is offline Code:(0xb39) Issue with assay run. Call Roche Service.
0xb3a Unable to save the result. Code:(0xb3a) Issue with assay run. Call Roche Service.
0xb3b The log file is: [LogFileName] You can The location of the temporary log file is
manually save the file through FTP displayed. Ask a user with Administrator access
Code:(0xb3b) role to get the file via FTP.
0xb50 No Network connections detected. Please Check your cable connections, wait a few
check your network connections. Code:(0xb50) minutes and attempt to reconnect. Contact
your network administrator to ensure network
settings are correct. If network is still not
detected, call Roche Service.
0xb51 Failed to reload lots from shared folder Check your network settings, cable
(Network), check your network connections, connections, then restart the analyzer.
re-login to reload the lots. Code:(0xb51)
0xb52 Volume set failed! Code:(0xb52) Restart the analyzer. If this error continues, call
Roche Service.
0xb61 No barcode scanned! Code:(0xb61) The barcode reader did not get a scan of the
barcode. Choose OK and try again.
0xb70 Battery level too low. Plug in AC power and Connect the analyzer to the mains power
press OK to continue. Code:(0xb70) supply and choose OK to continue.
0xb71 Motor PCB is not responding. Code:(0xb71) Restart the analyzer. If this error continues, call
Roche Service.
0xb72 Motor PCB has error: [FPGA/Config] Restart the analyzer. If this error continues, call
Code:(0xb72) Roche Service.
y List of error messages

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
114 Troubleshooting
List of error messages

Code Message Action


0xb73 Photometer PCB is not responding. Restart the analyzer. If this error continues, call
Code:(0xb73) Roche Service.
0xb74 Photometer PCB has error: [FPGA/Config] Restart the analyzer. If this error continues, call
Code:(0xb74) Roche Service.
0xb75 Thermal PCB is not responding. Code:(0xb75) Restart the analyzer. If this error continues, call
Roche Service.
0xb76 Thermal PCB has error: [FPGA/Config] Restart the analyzer. If this error continues, call
Code:(0xb76) Roche Service.
0xb77 Config data fixed, please reboot. Code:(0xb77) Restart the analyzer.
0xb78 System was unable to fix the problem, reboot Restart the analyzer. If this error continues, call
and try again. Code:(0xb78) Roche Service.
0xb79 Current Temp={0:00.00}°C is out of operating Operating temperature is out of range. Switch
0xb7c range. Please shut down and wait for the off the analyzer. Allow the analyzer to reach
device to stabilize between 4°C and 40°C suitable temperature before powering on again.
Code:([0xb79/0xb7c])
0xb7a Unable to open actuators. Code:(0xb7a) Restart the analyzer. If this error continues, call
Roche Service.
0xb7b Unable to move entry. Code:(0xb7b) Choose OK to continue or restart.
0xb7d You will not be able to run assays. Reboot Insert and remove the cleaning tool several
analyzer or perform maintenance. If error times. Restart the analyzer. If this error
persists, contact Roche Service. Code:(0xb7d) continues, call Roche Service.
0xb7e An old or a corrupted setup/settings file is Ask an Administrator to check the settings. If
detected at boot. Please have your supervisor this error continues, call Roche Service.
check the settings Code:(0xb7e)
0xb7f Internal storage space is running low. Please Do not run any assays until more storage is
make more space available. Code:(0xb7f) made available. Call Roche Service.
0xb80 Problem archiving assays results to Restart the analyzer. If this error continues, call
[DIRECTORY]:[MESSAGE] Code:(0xb80) Roche Service.
0xb81 Problem archiving logs to Restart the analyzer. If this error continues, call
[DIRECTORY]:[MESSAGE] Code:(0xb81) Roche Service.
0xb84 Manually move door to [position] position. Restart the analyzer. If this error continues, call
Code:(0xb84) Roche Service.
0xb85 Unable to connect to Script Manager Restart the analyzer. If this error continues, call
Code:(0xb85) Roche Service.
0xb86 No response from Dualport. Try reboot. Restart the analyzer. If this error continues, call
Code:(0xb86) Roche Service.
0xb87 The application version might not work with the Restart the analyzer. If this error continues, call
current embedded firmware. Code:(0xb87) Roche Service.
0xb88 Motor PCB firmware version expected: Restart the analyzer. If this error continues, call
[FirmwareVersion] Code:(0xb88) Roche Service.
0xb89 Motor PCB firmware version expected: Restart the analyzer. If this error continues, call
[FirmwareVersion] Code:(0xb89) Roche Service.
0xb8a Motor PCB firmware version expected: Restart the analyzer. If this error continues, call
[FirmwareVersion] Code:(0xb8a) Roche Service.
0xb8c Missing instrument data. Contact Roche Restart the analyzer. If error continues, call
Service. Code:(0xb8c) Roche Service.
0xba0 Photometer LUT value(s) out of range with Restart the analyzer. If this error continues, call
config LUT. Reboot to try again. If error persists, Roche Service.
Contact Roche Service. Code:(0xba0)
0xba1 Photometer Base value(s) out of range with Restart the analyzer. If this error continues, call
config Base. Reboot to try again. If error Roche Service.
persists, Contact Roche Service. Code:(0xba1)
y List of error messages

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Troubleshooting 115
List of error messages

Code Message Action


0xba2 iled to update current time to External RTC. Restart the analyzer. If this error continues, call
Code:(0xba2) Roche Service.
0xba3 Software upgrade is incomplete. Reboot and try Reboot the analyzer. If error continues, call
again to complete the upgrade. Code:(0xba3) Roche Service.
0xba4 Result summary file is being used by another Choose OK to continue. Restart the analyzer
user and can not be opened. Code:(0xba4) and/or the share folder server
0xba5 Run #[RUN_NR] on [Date] for sample ID Check the power cable connection. Restart the
"[SAMPLE_ID]" incomplete, if assay have not analyzer. If this error continues, call Roche
been repeated, please repeat assay again Service.
Code:(0xba5)
0xba6 Folder [FolderName] could not be accessed Restart the analyzer. If this error continues, call
Code:(0xba6) Roche Service.
0xbaa Unable to connect to SL folder. Check your log Check your network settings and connections.
files for further information. Code:(0xbaa) Restart and try again.
0xbab Unable to get a Key. Please try rebooting. Choose OK to continue. Reboot if error
Code:(0xbab) continues.
0xbad Password change FAIL. Please try again. Code: Password could not be saved. Try again.
(0xbad)
0xbaf Tube could not be added to the list of used Check your network connections. Restart and
tubes. Code(0xbaf) try again.
0xbb0 List of used tubes could not be opened. Check your network connections. Restart and
Code:(0xbb0) try again.
0xbb1 Lots file is being used by another user and can Choose OK to continue. Restart the analyzer
not be open. Code:(0xbb1) and/or the share folder server.
0xbb3 Unrecognized Liat Tube ID Code:(0xbb3) An invalid tube barcode is scanned. Try again.
If error continues call Roche Service.
0xbb4 Unrecognized insert ID. Code:(0xbb4) An invalid package insert barcode is scanned.
Try again. If error continues, call Roche Service.
0xbb5 Unrecognized Control ID Code:(0xbb5) An invalid control barcode is scanned. Try
again. If error continues call Roche Service.
0xbb6 Identification number checksum failed The checksum on the barcode is invalid. Try
Code:(0xbb6) again. If error continues, call Roche Service.
0xbb7 Not positive control barcode. Code:(0xbb7) If this error continues, call Roche Service.
0xbb8 Not negative control barcode. Code:(0xbb8) If this error continues, call Roche Service.
0xbb9 Barcode is expired! Code:(0xbb9) The barcode is expired. Ensured today’s date is
correct. Try again. If error continues, call Roche
Service.
0xbba This lot is expired! Code:(0xbba) Ensure today’s date is correct. Try again. If error
continues, call Roche Service.
0xbbb Duplicate Lot #, already validated. The lot has already been added and validated.
Code:(0xbbb) You can start using this lot.
0xbbc Error connecting to USB printer. Ensure it is Ensure USB printer is powered on and
connected and turned on. Code:(0xbbc) connected. Try again.
0xbbd Error connecting to Network printer. Ensure it Ensure network printer is powered on and
is connected and turned on. Code:(0xbbd) connected. Ensure printer settings are correct.
Try again.
0xbbe Invalid printer settings Ensure printer settings are correct. Try again.
0xbbf Sound could not be played. Code:(0xbbf) Choose OK to continue. Restart if error
continues.
0xbc0 Failed to set SNTP! Code:(0xbc0) Choose OK to continue. Restart if error
continues.
y List of error messages

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
116 Troubleshooting
List of error messages

Code Message Action


0xbc1 There is no assay/lot list in the device. If this error continues, call Roche Service.
Code:(0xbc1)
0xbc2 File missing: There is no assay/lot list in the First back up lots before attempting to restore
USB drive. Code: (0xbc2) lots.
0xbc3 Last run have detected a Config data Restart the analyzer. If this error continues, call
problem/mismatch. Reboot to restart device. Roche Service.
Code:(0xbc3)
0xbc4 Last ReSync have problem. Reboot to restart Restart the analyzer. If this error continues, call
device. Code:(0xbc4) Roche Service.
0xbc5 Last ReCal have problem. Reboot to restart Restart the analyzer. If this error continues, call
device. Code:(0xbc5) Roche Service.
0xbc6 Invalid Reset Code entered, please try again. The reset code was invalid. Try again. If it does
0xbc7 Code: (0xbc6) not work, call Roche Service.
0xbc8
0xbc9
0xbca The Reset Code you provided has already Choose OK and choose Password? on the
expired. Please start the Reset ADMIN login panel to start the procedure for resetting
Password process again. Code:(0Xbca) the administrator password again.
0xbf0 Send failed. An unknown HL error has There was an issue sending the result to the
occurred. Contact Roche Service. Code:(0xbf0) host, call Roche Service.
0xbf1 Send failed. ACK file from CME not found: There was an issue sending the result to the
[ACKFileName] Contact Roche Service. host, call Roche Service.
Code:(0xbf1)
0xbf2 Send failed. Contact Roche Service. There was an issue sending the result to the
0xbf4 Code:(0xbf2) host, call Roche Service.
0xbf5
0xbf3 Send failed. Please check your Check the network and connectivity
0xbf6 network/Connectivity connections and settings connection and settings in the Settings Menu
then try again. Code:(0xbf3) and try again.
Error 1 Upgrade failed. Call Roche Service.
IM Upgrade failed. Error code 1.
Please contact Roche Service.
Error 10 Upgrade failed. Power down the analyzer and call Roche
IM Upgrade failed. Error code 10. Service.
Please contact Roche Service.
[AssayName] has not been installed. Do you This assay has not been installed. Choose Yes
want to install this assay? to go to the Assay Menu to add the assay.
Choose No to abort running the assay.
[AssayName]: Script file is missing. Call Roche Choose OK. Ensure that the tube barcode is
Service. correct and scan it again. Alternatively,
manually enter the tube barcode (see the
information on barcode reading in this
publication). If error continues, call Roche
Service.
[NumberOfRecords] records found. It will take Choose Yes to view the results. You might
some time to load. Continue? need to wait for a long time. Choose No to
cancel viewing the results.
Activation code is expired. Please contact Choose OK and call Roche Service.
Roche in order to get a new activation code.
Your registration code: [RegistrationCode]
Activation code is invalid! Choose OK and call Roche Service.
Analyzer has not been initialized, Assays can Restart the analyzer. If error continues, call
not be performed. Roche Service.
y List of error messages

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Troubleshooting 117
List of error messages

Code Message Action


Audit log capacity has reached 100%. No Choose OK to continue.
further tests can be performed. Insert
Advanced Tools USB and select "Export and
Delete audit trail.
AutoCal in progress. This could take up to a Choose OK to continue. Wait for (busy) to
minute. disappear and try again.
AutoCal started. This could take up to a minute. Choose OK to continue. Wait for (busy) to
disappear and try again.
Auto-Lock Time value must be between 1 and Choose OK and enter a value between 1 and
10. 10.
Bad thermal reading. Restart the analyzer. If error continues, call
Channel=[SpecificChannelWithError] Roche Service.
Badge barcode already assigned. Choose Retry to try again or Cancel to cancel.
Badge barcode is already assigned to another Choose Retry to try again or Cancel to cancel.
user.
Badge barcode scan mismatch. Choose Retry to try again or Cancel to cancel.
Barcode could not be read. Try again. 1. Choose OK and try again.
2. In case of repeated failure, clean the
outside of the barcode reader window.
u Cleaning the window of the barcode
reader (127)
Battery level too low to run this assay, plug in Connect the analyzer to the mains power
AC power and try again supply to run this assay. Choose OK and try
again.
Battery may have insufficient power to run this It is suggested that you connect the analyzer to
assay. Do you really want to continue? the mains power supply to run this assay.
Choose Yes to run this assay. Choose No to
cancel.
Cannot locate upgrade package Call Roche Service, if you choose OK, the
analyzer can still be used.
Changes were not saved and will be lost. Do Choose Yes to discard the new user
you really want to exit? information input. Choose No to return to the
new user info panel.
Config file could not be reloaded: Restart the analyzer and if error continues, call
[ConfigFileName] Roche Service.
Contact Roche Service. Call Roche Service.
Do you really want to delete the following user: Choose Yes to delete the user. Choose No to
[user id] reject deleting the user.
Do you really want to restore default settings? Choose Yes to reset the settings to the default
settings. Choose No to keep the current
setting.
Enter a valid assay name! Choose OK and try again.
Enter a valid Calibration Choose OK and try again.
Enter a valid sample ID! Choose OK and try again.
Enter a valid User! Choose OK and try again.
Enter the data range in valid format. Format: Choose OK and try again.
MM,DD,YY-MM,DD,YY.
Enter the data range in valid format. Format: Choose OK and try again.
MM,DD,YY.
Error reading badge barcode. Choose OK and try again.
Failed to copy upgrade files Choose OK and try again.
y List of error messages

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
118 Troubleshooting
List of error messages

Code Message Action


Failed to delete the results. Retry, if problem Choose OK to continue.
persists call Roche Service.
Failed to open NTP0: Choose OK to continue. Restart if error
continues.
Failure to reset database. Restart the analyzer.
Failure to reset date. Restart the analyzer.
File could not be saved! Check the Install Check your install source setting and try again.
source field and access level!
File was not found! Choose OK to continue.
Hard disk drive is full. Archive and delete some Internal storage space is full. You must move or
data. delete files to make more room in order to
continue to run assays (move or delete some
files).
Invalid Activation Code. Please try again Choose OK and try again.
Invalid assay. Repeat assay. If it still fails, contact Roche
Service.
Invalid barcode: Choose OK and scan again.
Invalid date/time entered Choose OK and try again.
Invalid Tube Ensure that the same assay tube is scanned
again.
Invalid user ID entered: [user name entered] Incorrect user ID entered or scanned. Choose
OK and try again.
Invalid Password Choose OK and try again.
It's not possible to add more than 500 users. Choose OK, delete unused users and try again.
Log file [LogFileName] could not be saved. Try Choose Yes and try to save again.
again?
Lot does not exist. Do you want to add this lot? This lot of assay tubes has not been validated.
Choose Yes to go to the Assay Menu panel to
add the lot. Choose No to abort running this
assay.
Machine name can not be empty! Name of the analyzer cannot be empty. Choose
OK and try again.
Missing RunTime folder,cannot execute Liat Call Roche Service.
application
New Lot validation not complete. Do you want Choose Yes to go to the Assay Menu to finish
to continue the validation? the add lot validation. Choose No to abort
running the assay.
No connection to the server can be established. Choose OK, check the connectivity settings
Configure secure communication. and try again.
No Events were logged. For your information. Choose OK.
No rights to run this type of assay! Ask your supervisor to add the assay to the
Allow Assay list in your user profile.
Out of sync Motor 3. Check that the tube is inserted all the way.
Please input: [Server Name/IP address/Share Indicated settings are empty. Choose OK and
Name/Folder Path/User name/Password!] enter the specified settings.
Printing… Choose OK. Wait for print to finish.
Port value must be between 1 and 65535. Choose OK and try again.
Remove the assay tube before logging on as Choose OK and remove the assay tube from
another user. the analyzer.
y List of error messages

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Troubleshooting 119
List of error messages

Code Message Action


Remove the tube slowly and carefully. Hit Carefully pull the tube out.
<OK> to continue. (Do NOT pull the tube out
forcibly.)
Remove the USB key in order to continue. Choose OK and remove the USB key from the
rear of the analyzer.
Sample ID exceeds maximum length Choose OK and try again.
(60 chars).
Scanned badge barcode does not match a Choose OK and try again.
known user.
Server does not respond. Check the connectivity settings and try again.
Server's certificate expired. Contact the administrator of your host system.
Server's certificate name mismatch. Check the connectivity settings or contact the
administrator of your host system.
Server's certificate untrusted. Check the connectivity settings and try again.
SNTP Server cannot be empty Choose OK and try again, or set SNTP option
to No. See the information on the system
settings in this publication.
Some of the provided settings are incorrect. Choose OK to continue.
Please refer to the user manual or contact
Roche Service.
System is busy. Choose OK. Wait for (busy) to disappear and
try again.
System Reset go back to <Run Assay> screen. Choose OK to continue.
Code: [ErrorCode]
The Activation Code you provided has already Choose OK and call Roche Service.
expired. Please contact Roche Service to get a
new Activation Code.
The Assay ‘[AssayName]’ version Choose OK, make sure it is the correct USB key
‘[AssayVersion]’ is not compatible with the and otherwise call Roche Service.
current SW version ‘[SoftwareVersion]’’
The certificate returned by the server has Contact the administrator of your host system.
expired.
The certificate returned by the server has a Contact the administrator of your host system.
wrong host name.
The current version ([AssayVersion]) for Assay Choose OK, make sure it is the correct USB key
‘[AssayName]’ is newer than the detected and otherwise call Roche Service.
update ([AssayVersion]). This update will be
discarded
The first scanned badge barcode is not Choose Retry to try again or Cancel to cancel.
identical to the second.
The grace period for this assay has expired. Choose Activate to register and activate your
Please contact Roche Service in order to assay(s) or choose Cancel to continue.
activate the assay
The grace period for this assay has expired. Choose OK and inform your Administrator.
Please inform an Administrator to contact
Roche Service to activate the assay.
The instrument´s Audit logs have reached Choose OK to continue.
100%. No further tests can be performed.
Contact your Administrator immediately.
The instrument´s Audit logs reached [80/90]%. Choose OK to continue.
Contact your Administrator.
y List of error messages

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
120 Troubleshooting
List of error messages

Code Message Action


The instrument´s Audit logs reached [80/90]%. Choose OK to continue.
To free up space, insert Advanced Tools USB
drive and export audit logs.
The length of the password must be between 4 Choose OK and try again.
and 20 characters.
The software update package is corrupted. Call Roche Service, if you choose OK, the
Please contact Roche Service. analyzer can still be used.
The system could not find any assay script file Choose OK, make sure it is the correct USB key
on the USB drive and otherwise call Roche Service.
The system does not have enough storage to Internal storage space is full. Move or delete
perform the assay(s) install/update files to free space so you can continue to run
assays (move or delete some files).
The update failed due to unknown reasons. Choose OK and try again.
System will be restored. Please contact Roche
Service.
The updated ‘[AssayVersion]’ version for Assay Choose OK, make sure it is the correct USB key
‘[AssayName]’ does not come from a valid and otherwise call Roche Service.
source. This update will be discarded
The upgrade is not compatible with the Call Roche Service.
currently installed version.
The validation of the software package failed Call Roche Service, if you choose OK, the
analyzer can still be used.
There was an error adding assay '[AssayName]' Choose OK and try again.
version '[AssayVersion]'.
There was an error restoring the assay Choose OK and try again.
'[AssayName]' version '[AssayVersion]'. Please,
try reinstalling the assay.
There was an error updating assay Choose OK and try again.
‘[AssayName]’ to version ‘[AssayVersion]’. The
current version will be kept.
Thermal error. Channel=[ChannelName] Restart the analyzer. If error continues, call
Roche Service.
This server does not support secure Contact the administrator of your host system.
connectivity compatible with the Liat analyzer.
Time zone could not be set Choose OK and try again.
Tube entry door error. Check the door and try Check the tube entry door for blockage. Retry
again or press manual button to operate the or manually move the door to the correct
door. positions (i.e., with the tube inserted, carefully
open and close the door).
Tube insert time must be between 1 to 20! Choose OK and try again.
To restart the analyzer, press the <OK> button. Record the message code and call Roche
Code: [ErrorCode] Service. Choose OK to restart.
Unable to connect to Share Folder. Choose OK to continue. Restart the analyzer
and/or the share folder server.
Unknown error Code: ([ErrorCode]) Record the message. Restart the analyzer. If
this error continues, call Roche Service.
Unknown user ID: [user ID]. Choose OK and try again.
Unregistered Assay(s) found. Please contact Choose Activate to register and activate your
Roche Service to register the assay(s) within assay(s) or choose Later to continue.
the next [NumberOfDays] days.
y List of error messages

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Troubleshooting 121
List of error messages

Code Message Action


Unregistered Assay(s) found. Please inform an Choose OK and inform your Administrator.
Administrator to get in contact with Roche
Service in order to register and activate your
assay(s) within the next [NumberOfDays] days.
Unregistered software version. Choose OK and inform your Administrator.
Please contact an Administrator to activate the Running assays is still possible until the
software within the next [NumberOfDays] days registration period has expired.
Unregistered software version. Choose Activate to register and activate your
Please contact Roche Service to activate the software or choose Later to continue.
software within the next [NumberOfDays] days.
Registration code: [RegistrationCode]
Unregistered software version. Choose OK and inform your Administrator.
You are no longer able to run assays. Please
contact an Administrator to activate the
software.
Unregistered software version. Choose Activate to register and activate your
You are no longer able to run assays. Please software or choose Later to continue.
contact Roche Service to activate the software.
Registration code: [RegistrationCode]
Unsaved data may be lost. Do you really want Choose Yes to log on. Choose No to return to
to log off the current user? the walk-by panel.
Upgrade check failed. Check the Call Roche Service if error continues.
documentation, correct your data, and try
again.
Upgrade failed. IM Upgrade failed. IMUpgrade Call Roche Service.
did not finish in time. Please contact Roche
Service
Upgrade failed. IM Upgrade failed. IMUpgrade Call Roche Service.
does not exist. Please contact Roche Service.
Upgrade failed. Missing RunTime folder. Please Call Roche Service.
contact Roche Service.
Upgrade failed. Something's wrong, \Storage Call Roche Service.
Card\CobasRunTime\ exist. Please contact
Roche Service.
User already exists: Do you want to edit the Choose Yes to update/overwrite the existing
user? user's information. Choose No to cancel and
return to the new user panel.
User Id and Password can not be empty! Choose OK and try again.
Year must be between 1980 to 2080 The year entered is not valid. Choose OK and
try again.
You do not have the access rights to add this Ask your supervisor to add the assay to the
assay. Allow Assay list in your user profile.
You need to change your password to log on. Choose OK and try again.
Your system time is not correct. Please correct Choose OK and navigate to the System
it first in order to update the software. Settings panel. Set the time to the current time
and try again to install the software package.
y List of error messages

Hardware-related and firmware-related Hardware-related codes and firmware-related


codes codes are generated in case of events related to
hardware or module failure during assay runs. These
codes appear in the following formats:
• Prefix codes
• Hexadecimal codes

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
122 Troubleshooting
List of error messages

The correlation between these code formats is shown in


the following table:

Modules Prefix Code range


General – 0x1 – 0x10
Motor MO 0x001 – 0x0FF
Thermal TP 0x101 – 0x1FF
Photometer PM 0x201 – 0x2FF
Hardware HW 0x301 – 0x3FF
File Transfer FT 0x401 – 0x4FF
Miscellaneous MI 0x501 – 0x5FF
CE / Script CE 0xA01 – 0xAFF
Unsolicited message UM 0xF01 – 0xFFF
y Hardware- and firmware-related codes

Prefix codes appear as “XX-YYYYY-YYY”. The following


rules apply:
• “XX” denotes the affected module (e.g., MO).
• The 5th number (XX-YYYYY-YYY) defines the severity
of the issue.

q A severity of 4 or less (e.g., MO-00071-000) is a


Warning that can be self-corrected by the analyzer. No
action is necessary. The result generated from the assay
run is valid.

q A severity of 5 or greater (e.g., MO-00075-000) is an


Error, and aborts the assay run. If the issue recurs
systematically, contact Roche Service.

Some hardware-related and firmware-related codes are


listed in the following table:

Code Message Action


0x1 Config file on SD card has error Code:(0x1) Restart the analyzer. If this error continues, call
Roche Service.
0x2 Embedded PCB initialization failed: Restart the analyzer. If this error continues, call
[Motor/Thermal/Photo] [FPGA/config] Roche Service.
Code:(0x2)
0x3 Motor Initialization failed (0x3) Restart the analyzer. If this error continues, call
Roche Service.
0x4 [Motor/Thermal/Photo] system serial numbers Restart the analyzer. If this error continues, call
do not match with the one on SD Card Roche Service.
Code:(0x4)
0x5 Embedded PCB config data mismatch Restart the analyzer. If this error continues, call
Code:(0x5) Roche Service.
0x6 Thermal Initialization failed Code:(0x6) Restart the analyzer. If this error continues, call
Roche Service.
y Hardware-related and firmware-related codes

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Troubleshooting 123
List of error messages

Code Message Action


0x7 Read all temperature command failed Restart the analyzer. If this error continues, call
Code:(0x7) Roche Service.
0x8 Failed to shutdown thermal Code:(0x8) Restart the analyzer. If this error continues, call
Roche Service.
0xa Motion calibration LUT failed Code:(0xa) Restart the analyzer. If this error continues, call
Roche Service.
0xb Config LUT values are invalid (CompOn) Code: Restart the analyzer. If this error continues, call
(0xb) Roche Service.
0xc Motion calibration call failed Code:(0xc) Restart the analyzer. If this error continues, call
Roche Service.
0xd Motion calibration value(s) out of range with Restart the analyzer. If this error continues, call
config LUT Code:(0xd) Roche Service.
0xe Photometer LUT value(s) out of range. Reboot Restart the analyzer. If this error continues, call
after initialization completes. Contact Roche Roche Service.
Service if error persists. Code:(0xe)
0xf Cleaning of photometer is recommended. Use the provided cleaning tool following the
Shutdown the instrument and use the cleaning instructions included with the cleaning tool kit.
tool. Follow instructions from "Cleaning Tool Restart the analyzer. If this error continues, call
Guide". Code:(0xf) Roche Service.
0x10 Cleaning of photometer is needed. Shutdown Use the provided cleaning tool following the
the instrument and use the cleaning tool. instructions included with the cleaning tool kit.
Follow instructions from "Cleaning Tool Guide". Restart the analyzer. If this error continues, call
Code:(0x10) Roche Service.
0x503 To restart the analyzer, press the <OK> button. Call Roche Service. Press OK to reboot.
Code:0x503
0x504 To restart the analyzer, press the <OK> button. Call Roche Service. Press OK to reboot.
Code:0x504
0x505 To restart the analyzer, press the <OK> button. Call Roche Service. Press OK to reboot.
Code:0x505
0xF31 Assay Aborted Due to Error Code Restart the analyzer. If this error continues, call
0xF32 [0xF31/0xF32] Roche Service.
Analyzer is not level. Place analyzer on level
surface.
0xF33 Assay Aborted Due to Error Code 0xF33 Restart the analyzer. If this error continues, call
Tube in Place Lost. Roche Service.
0xF61 Assay Aborted Due to Error Code 0xF61 Restart the analyzer. If this error continues, call
Bad thermal reading. Channel=[Channel Nr.] Roche Service.
0xF62 Assay Aborted Due to Error Code 0xF62 Restart the analyzer. If this error continues, call
Thermal error. Channel=[Channel Nr.] Roche Service.
0xF91 Assay Aborted Due to Error Code 0xF91 Restart the analyzer. If this error continues, call
[Motor/Thermal/Photometer] config file load Roche Service.
failed
0xF92 Assay Aborted Due to Error Code 0xF92 Restart the analyzer. If this error continues, call
[Motor/Thermal/Photometer] external RAM Roche Service.
error
0xF93 Assay Aborted Due to Error Code 0xF93 Restart the analyzer. If this error continues, call
[Motor/Thermal/Photometer] serial flash error Roche Service.
0xF94 Assay Aborted Due to Error Code 0xF94 Restart the analyzer. If this error continues, call
Thermal runaway (enable). Channel=[Channel Roche Service.
Nr.]
0xF95 Assay Aborted Due to Error Code 0xF95 Restart the analyzer. If this error continues, call
Thermal runaway (disable). Channel=[Channel Roche Service.
Nr.]
y Hardware-related and firmware-related codes

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
124 Troubleshooting
Generating a backup for troubleshooting purposes

Assay failure codes and assay pattern codes Assay failure codes are generated for invalid test
results.

Assay pattern codes are generated for abnormal PCR


curve patterns. These codes may appear in assay runs
which show invalid results.

q Assay failure codes and assay pattern codes are


assay-specific. Refer to the cobas® Liat® Assay package
insert or the instructions for use for more information.
Contact Roche Service if the failure persists.

Generating a backup for troubleshooting purposes


If you encounter a problem, Roche recommends to
generate a backup, which you then can send to your
Roche representative.

! CAUTION
Data security
Data backed up by the advanced tools key is stored as
plain text files and so their content is accessible to
unauthorized persons.
r Ensure that you store backed up data safely and
securely so that it is not accessible by unauthorized
persons.

The diagnostic backup contains all relevant data required


to perform diagnostics. Once you have generated this
backup using your advanced tools key, you need to
prepare it on a Windows computer for transfer.
u For information on the advanced tools key, see the
cobas® Liat® Advanced Tools Key Guide.

Viewing and printing the event log


Certain error messages are recorded in a log file, which
you can view and print.

q If configured, the analyzer sends events to a


connected DMS.
u About data exchange with a DMS (86)

Roche Diagnostics
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Troubleshooting 125
Resetting the lost default administrator password

j m Logged on with Supervisor or Administrator access


role.

r To view the event log

1 Choose Tools > Event Log.


I Large event logs might take some time to load.

2
2 To print the event log, choose the Print button.

Resetting the lost default administrator password


If you have lost the password of the default administrator
account ADMIN, you can apply for a new one with your
Roche representative.

d m Defined account with Administrator access role.

r To reset your default administrator


password

1
1 On the login panel, choose the Password? button.

2 On the message dialog box, choose the Yes button to


confirm that you no longer have access to the
administrator password.
f An eight-digit key is displayed, which is valid for
24 hours.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
126 Troubleshooting
Resetting the lost default administrator password

3
3 Make a note of the key displayed in the message.
I Do not touch the screen until you have received
the reset code.

4 Contact your Roche representative and request a


password reset.
I You need to provide proof of identity and the
eight-digit key that was generated by the analyzer.

5 After successful verification, you will receive an eight-


digit reset code, which is valid for 24 hours.

6 On the message dialog box, choose OK.

7
7 On the Enter Reset Code panel, enter the code
provided by your Roche representative.

8 Choose the OK button.


f If the code is valid, the Enter Password panel is
displayed.

9
9 Enter a new administrator password.

10
10 Choose the OK button.
f A success message is displayed.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Troubleshooting 127
Cleaning the window of the barcode reader

Cleaning the window of the barcode reader


Dried residue on the outside of the barcode reader
window may cause repeated failure to scan barcodes.
Clean the window to ensure trouble-free operation.

! CAUTION
Electric shock
r Do not spray or apply liquid directly on the analyzer.

NOTICE
Damage to the analyzer due to use of unsuitable
cleaning materials
Using unsuitable cleaning materials can damage the
window of the barcode scanner.
r Do not use harsh, abrasive cleaners or wipes.

d m Soft lint-free cloth


m 70% isopropanol

j • Repeated failure to scan barcodes.

r To clean the window of the barcode


reader

1 Switch off the analyzer.

2 Moisten a lint-free cloth with 70% isopropanol.

3
3 Gently wipe the outside of the barcode reader
window.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
128 Troubleshooting
Resolving a tube entry door error before the start of a run

Resolving a tube entry door error before the start of a run


If you insert the assay tube just at the end of the tube
insert time, a tube entry door error may occur.

j m Assay tube is inserted in analyzer.


m Error message “Tube entry door error. Check the door
and try again or press manual button to operate the
door.” is displayed.

r To resolve a tube entry door error


before the start of a run
1 Manually remove the assay tube from the analyzer.

2
2 On the message dialog box, choose the Manual
button. Choose the OK button.

3
3 To run the assay, continue with step 9 of (u 46).

Resending results manually


If the analyzer is configured to send results automatically
to a host, but the transmission fails, you have to review
the results on the analyzer and resend them manually.

On the Results panel, results that were sent to the host,


but not received by the host, are marked with .

j m Automatic sending of results failed.


m Logged on with Supervisor or Administrator access
role.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Troubleshooting 129
Restarting an unresponsive analyzer

r To resend results manually

1 On the main menu, choose the Results option.

2
2 On the Results panel, review and send the results as
described in (u 53).

Restarting an unresponsive analyzer


If the analyzer becomes unresponsive, power off and
restart it.

j m Analyzer unresponsive

r To restart an unresponsive analyzer

1
1 If the analyzer is completely unresponsive, press the
power button and hold it down for 5–10 seconds until
the analyzer powers off.

2 Wait for about 10 seconds.

3 To restart the analyzer, press the power button again.

4 Follow the instructions on the screen.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
130 Technical data
Technical characteristics

Technical data
To ensure trouble-free operation, ensure that you use the
components listed below and that the conditions
mentioned in this section are met.

In this section
Technical characteristics (130)
Environmental conditions (130)
Storage and transport conditions (131)
Standard supplies (131)
Printer (132)

Technical characteristics
The analyzer has the following technical characteristics:

Analyzer
User interface Built-in touch screen & keypad
Internal storage capacity Approximately 20,000 test results with date and time can be
stored on the analyzer (depending on result file size)
Barcode reader Class 2 Laser Product
For barcodes, the following standards are supported: Code
39, 93, 128, Codabar, GS1 Databar-14.
Connectivity port Ethernet, RJ-45, TCP/IP
2 Universal Serial Bus (USB)
(maximum load of 250 mA)
Main connection Power supply adapter: Input 100-240 V AC / 50-60 Hz
Output: 15 V DC / 8.6 A
Power consumption 130 W on AC mains power
Safety class II
Dimensions (L x W x H) 24.1 cm x 11.4 cm x 19.0 cm (9.5 in x 4.5 in x 7.5 in)
Weight 3.76 kg (8.3 lbs)
y Technical data

Environmental conditions
For operation, the following environmental conditions
must be met.

Analyzer
Temperature range +15 °C to +32 °C (59 °F to 90 °F) recommended
Relative humidity 15% to 80% (non-condensing)
Maximum altitude 2000 m (6500 ft) above sea level
y Environmental conditions

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cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Technical data 131
Storage and transport conditions

Other environmental conditions • Indoor use only


• Horizontal installation space
• Dust-free environment with adequate ventilation
• No direct sunlight
• No perceptible vibration
• No equipment generating electromagnetic waves in
the near vicinity
• No machines discharging ultrahigh frequencies (e.g.,
electric discharger)

Storage and transport conditions


For storage and transport, the following ambient
conditions must be met.

Analyzer
Temperature range -20 °C to +60 °C (-4 °F to +140 °F)
Storage relative humidity 10% to 95% (non-condensing)
y Storage and transport conditions

Standard supplies
For trouble-free operation, use the following standard
supplies:

Name

cobas® Liat® Analyzer


cobas® Liat® Advanced Tools Key
Universal Power Supply
Power cable
cobas® Liat® Assay Tube
Read the package insert or the instructions for use for detailed
product data and usage limitations.
cobas® Liat® Cleaning Tool Kit
y Standard supplies

The assay tubes are specific to each assay. The Roche


catalog of assays is constantly expanding. Contact your
Roche representative for a complete list of cobas® Liat®
assays available for IVD use.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
132 Technical data
Printer

Printer
A standard PCL compatible printer (laser or inkjet) that
can be connected either to the USB port or via data
network.

q PCL 3 GUI is not supported.

Reports printed on an inkjet printer can be damaged by


moisture or liquid. It is therefore recommended to use a
laser printer.

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Index 133

Index
A

Abbreviations, 10
Aborting assays, 49
Access roles, 90
Adding
– assay tube lots, 70
Addresses, 5
Adjustment
– automatic, 106
Analyzer
– cleaning outside, 109
– functions, 22
– operating elements, 24
– setting up, 60
– starting, 28
– switching off, 44
– unresponsive, 129
Approvals, 4
Assay tube lots
– adding, 70
– deleting, 75
– sharing, 70, 83
Assay tubes, 22
Assays
– aborting, 49
– adding tube lots, 70
– deleting tube lots, 75
– installing from local source, 66
– installing from remote service platform, 64
– installing from USB key, 62
– overview, 25
– performing, 46
– registering, 68
– uninstalling, 76
– updating from remote service platform, 64
– updating from USB key, 62
Audit trail, 23
Auto adjustment, 106
Auto monitoring, 105
Auto-lock function, 39
Automatic adjustment, 106
Automatic restart, 105

Backup for troubleshooting, 124


Badge barcode
– assigning, 34
– changing, 34
– removing, 34
– replacing, 34
Barcode reader, overview, 25
Barcodes, scanning, 37

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
134 Index

Buttons
– function, 25
– navigation, 25

Calibration
– touch screen, 107
Changing user information, 94
Characteristics, technical, 130
Checks, automatic, 23
Cleaning
– ouside of analyzer, 109
– spillages, 110
– touch screen, 109
Code
– assay failure, 124
– assay pattern, 124
– firmware error, 121
– hardware error, 121
– software error, 111
Conditions
– environmental, 130
– for operation, 130
– storage, 131
– transport, 131
Contact, 5
Controls, 77
Conventions used in this publication
– abbreviations, 10
– product names, 9
– symbols, 9
Copyright, 3

Data management system


– about data exchange, 86
– connecting analyzer, 88
Data management system connections, 85
Defining
– HIS, LIS, DMS connections, 85
– network, 81
– network resources, 82
– system, 79
– users, 91
– values, 60
Definitions
– HIS, LIS, DMS connections, 85
– network, 81
– network resources, 82
– system, 79
Deleting
– assay tube lots, 75
– results, 57
– users, 95
Disposal, analyzer, 16
DMS connnections, 85

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Index 135

Documents, supporting, 2

Edition notice, 2
Entering text and numbers, 37
Environmental conditions, 130
Error
– assay, 124
– firmware, 121
– software, 111
– tube entry door, 128
Event log, 124

Feedback, 4
Flap, for assay tubes, 25
Function buttons, 25
Functions, analyzer, 22

Graphs, 52

HIS connections, 85
Hospital information system connections, 85

IDs, system elements, 103


Information, additional, supporting, 2
Installation, 17
Installing
– assays from local source, 66
– assays from remote service platform, 64
– network printer, 21
– USB printer, 20
Installing assays
– from USB key, 62
Instrument
– See Analyzer
Instrument approvals, 4
Intended use, 9

Labels, on analyzer, 16
Laboratory information system connections, 85
LIS connections, 85
List of messages, 111
Locking the analyzer manually, 41
Locking users, 94
Log files, 124

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
136 Index

Logging on, 29
– with badge barcode, 30
– with user ID, 30
Lots
– control results, 77
– information, 77

Maintenance, 105
Messages, 111
Monitoring, 105

Navigation buttons, 25
Network definitions, 81
Network resources, 81
New in version 7.2, 12
Numbers, entering, 37

Operating elements, 24
Overview
– assays, 25
– barcode reader, 25
– results, 52
– touch screen, 26

Password
– changing, 31
– changing anytime, 32
– changing at logon, 33
– resetting for Administrator, 125
Passwords
– about, 91
Patents, 4
Performing
– assays, 46
– runs, 45
Power switch, 25
Powering on, 28
Printer
– compatibility, 132
– installing network, 21
– installing USB, 20
Printing
– lot control results, 77
– lot information, 77
Product names, 9

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Index 137

Quality control, 104

Reading barcodes, 37
Registering
– assays, 68
– software, 100
Remote service platform, 64
Reports, 52
Resetting Administrator Password, 125
Results
– deleting, 57
– lot controls, 77
– overview, 52
– reviewing, 53
Reviewing results, 53
Revision history, 2
Running assays, 46
Runs, performing, 45

Safety
– classification, 14
– disposal, 16
– labels, 16
– summary, 14
Scanning barcodes, 37
Screen
– See Touch screen
Screenshot disclaimer, 3
Selecting items, on screen, 36
Self-checks, 23, 105
Service, 106
Settings
– See Definitions
Setup
– analyzer, 60
– HIS, LIS, DMS connections, 85
– network, 81
– network resources, 82
– system, 79
Share lot function
– disabling, 84
– using, 83
Shutting down analyzer, 44
Software
– installed versions, 102
– registering, 100
– updating, 97
Specifications, 130
Spillages, 110
Starting
– analyzer, 28
Storage conditions, 131

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
138 Index

Supplies, 131
Support, 4
Supporting documents, 2
Switching off analyzer, 44
Symbols used in this publication, 9
System elements
– versions and IDs, 103
System settings, 79

Technical data, 130


Text, entering, 37
Touch screen
– calibrating, 107
– cleaning, 109
– overview, 26
– selecting items, 36
– selecting predefined items, 36
Trademarks, 3
Transport conditions, 131
Troubleshooting, 111
– backup, 124
Tube entry door, 25
Tube entry door error
– resolving, 128
Turning off analyzer, 44

Uninstalling assays, 76
Unlocking the analyzer, 42
Unlocking users, 94
Updating assays
– from remote service platform, 64
– from USB key, 62
Updating software, 97
USB key
– for assay installation, 62
– for assay update, 62
User IDs
– about, 91
User rights, 90
Users
– changing information, 94
– defining, 91
– deleting, 95
– locking, 94
– unlocking, 94

Versions
– software, 102
– system elements, 103

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
Index 139

Warranty, 3

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001
140 Index

Roche Diagnostics
cobas® Liat® System · Software version 3.1 · Operator's Manual · Version 7.2 P/N: 08276340001

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