Roche cobas 5800 User manual

Type
User manual

This manual is also suitable for

cobas omni Utility Channel IVD
User Assistance Version 1.0
Utility Channel Tool software version 3.0
Optimization Tool software version 3.0
Roche Diagnostics
cobas omni Utility Channel IVD · User Assistance · Version 1.0
2
Publication information
Edition notice This publication is intended for operators of the
cobas omni Utility Channel.
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.
!
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.
Training Do not carry out operation tasks or maintenance actions
unless you have received training from Roche
Diagnostics. Leave tasks that are not described in the
user documentation to trained Roche Service
representatives.
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 system renders the
warranty or service agreement null and void.
For conditions of warranty, contact your local sales
representative or refer to your warranty contract partner.
Always leave software updates to a Roche Service
representative or perform such updates with their
assistance.
Copyright © 2015-2017, F. Hoffmann-La Roche Ltd. All rights
reserved.
Publication
version
Software version Revision date Change description
1.0 3.0 July 2017 First version
y Revision history
Roche Diagnostics
cobas omni Utility Channel IVD · User Assistance · Version 1.0
3
License information cobas omni Utility Channel Tool and cobas omni
Optimization Tool are protected by contract law, copyright
law, and international treaties.
cobas omni Utility Channel Tool and cobas omni
Optimization Tool contain a user license between F.
Hoffmann-La Roche Ltd. and a license holder, and only
authorized users may access the software and use it.
Unauthorized use and distribution may result in civil and
criminal penalties.
Open Source and Commercial Software cobas omni Utility Channel Tool and cobas omni
Optimization Tool may include components or modules of
commercial or open-source software. For further
information on the intellectual property and other
warnings, as well as licenses pertaining to the software
programs included in cobas omni Utility Channel Tool
and cobas omni Optimization Tool, refer to the
electronic distribution included with this product.
This open source and commercial software and
cobas omni Utility Channel Tool and cobas omni
Optimization Tool as a whole can constitute a device
regulated in accordance with applicable law. For more
detailed information, refer to the user manual and
labeling.
Please note that the respective authorization is no longer
valid according to the corresponding legislation should
any unauthorized changes be made to
cobas omni Utility Channel Tool and cobas omni
Optimization Tool.
Trademarks The following trademarks are acknowledged:
COBAS, COBAS OMNI, TAQMAN, AMPERASE, and LIFE
NEEDS ANSWERS are trademarks of Roche.
All other trademarks are the property of their respective
owners.
Feedback Every effort has been made to ensure that this publication
fulfills the intended use. All feedback on any aspect of
this publication is welcome and is considered during
updates. Contact your Roche representative, should you
have any such feedback.
Approvals
cobas omni Utility Channel Reagent Kit The cobas omni Utility Channel Reagent Kit 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.
Roche Diagnostics
cobas omni Utility Channel IVD · User Assistance · Version 1.0
4
The following marks demonstrate compliance:
Compliance is provided by means of the Declaration of
Conformity.
RFID reader/writer The RFID reader/writer provided with the
cobas omni Utility Channel meets the requirements laid
down in:
Directive 2014/53/EU of the European Parliament and of
the Council of 16 April 2014 on the harmonization of the
laws of the Member States relating to the making
available on the market of radio equipment and repealing
Directive 1999/5/EC.
The following marks demonstrate compliance:
Compliance is provided by means of the Declaration of
Conformity. To view the full text of the 2014/53/EU
declaration of conformity, go to the Roche DiaLog Global
Web Site (https://dialog1.roche.com/) and choose the
eLabDoc link.
If you are unable to access Roche DiaLog, contact a
Roche Service representative.
For in-vitro diagnostic use.
Complies with the IVD directive 98/79/EC.
IVD
Complies with the Radio Equipment directive
2014/53/EU
Roche Diagnostics
cobas omni Utility Channel IVD · User Assistance · Version 1.0
5
Contact addresses
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Switzerland
Distributed in the US by:
Roche Diagnostics
9115 Hague Road
Indianapolis
Indiana
USA
Roche Diagnostics
cobas omni Utility Channel IVD · User Assistance · Version 1.0
6
Table of contents 7
Roche Diagnostics
cobas omni Utility Channel IVD · User Assistance · Version 1.0
Table of contents
Publication information 2
Contact addresses 5
Table of contents 7
Intended use 9
Symbols and abbreviations 9
Safety classifications 10
Safety information 12
Operation
1 Operation software
Workflows 17
Utility channel software 19
RFID reader/writer 30
Installing a UC analysis package onto the
system 33
Preparing the reagent cassette 38
Performing and viewing tests 45
Optimization software
2 Optimization software
About the optimization software 51
About the optimization software user
interface 52
Workflows 54
Using the optimization software 56
Appendix
3 Utility channel test guidelines
Recommendations for test design 73
Disclaimer 74
Primer and probe 75
PCR profile 81
Controls 83
Optimizing a qualitative real time PCR test 84
References 95
Attachment 1: Examples for PCR profiles 96
Attachment 2: Primer design software
programs available on the Internet 97
4 Installing the software
Installing the utility channel software 101
Installing the optimization software 104
Index
Index 109
8 Table of contents
Roche Diagnostics
cobas omni Utility Channel IVD · User Assistance · Version 1.0
Roche Diagnostics
cobas omni Utility Channel IVD · User Assistance · Version 1.0
9
Intended use
The cobas omni Utility Channel suite of products are
intended for use with the open channel functionality of
the cobas
®
6800/8800 Systems.
Symbols and abbreviations
Product names Except where the context clearly indicates otherwise, the
following product names and abbreviations are used:
Symbols used in the publication
Product name Abbreviation
cobas
®
6800/8800 Systems
system
cobas
®
Buffer Negative
Control Kit
negative control
cobas omni Optimization Kit optimization kit
cobas omni Utility Channel
Tool
utility channel software
cobas omni Utility Channel
Reagent Kit
reagent kit
cobas omni Utility Channel
Master Mix Reagent 2
master mix reagent 2
cobas omni Optimization
Tool
optimization software
Master Mix Reagent 1 master mix reagent 1
y Product names
Symbol Explanation
o List item
u Related topics containing further information
q
Tip. Extra information on correct use or useful
hints.
r Start of a task
I Extra information within a task
f Result of an action within a task.
c Frequency of a task.
n Duration of a task.
d Materials that are required for a task.
j Prerequisites of a task.
u Topic. Used in cross-references to topics.
p Task. Used in cross-references to tasks.
w
Figure. Used in figure titles and cross-
references to figures.
y Symbols used in the publication
Roche Diagnostics
cobas omni Utility Channel IVD · User Assistance · Version 1.0
10
Abbreviations The following abbreviations are used.
Safety classifications
The safety precautions and important user notes are
classified according to the ANSI Z535.6-2011 standard.
Familiarize yourself with the following meanings and
icons:
!
Safety alert
r The safety alert symbol is used to alert you to potential
physical injury hazards. Obey all safety messages that
follow this symbol to avoid possible damage to the
system, injury, or death.
These symbols and signal words are used for specific
hazards:
WARNING
!
Warning...
r ...indicates a hazardous situation which, if not avoided,
could result in death or serious injury.
y
Table. Used in table titles and cross-references
to tables.
z
Equation. Used in cross-references to
equations.
k
Code example. Used in code titles and cross-
references to codes.
Symbol Explanation
y Symbols used in the publication
Abbreviation Definition
ANSI American National Standards
Institute
CSA Canadian Standards Association
EC European Community
IVD in-vitro diagnostic
TCP Transmission Control Protocol
UL Underwriters Laboratories Inc.
y Abbreviations
Roche Diagnostics
cobas omni Utility Channel IVD · User Assistance · Version 1.0
11
CAUTION
!
Caution...
r ...indicates a hazardous situation which, if not avoided,
could result in minor or moderate injury.
NOTICE
Notice...
...indicates a hazardous situation which, if not avoided,
may result in damage to the system.
Important information which is not safety relevant, is
indicated with the following icon:
q Tip...
...indicates additional information on correct use or useful
tips.
Roche Diagnostics
cobas omni Utility Channel IVD · User Assistance · Version 1.0
12 Safety information
Safety information
Data loss or unavailability of the system due
to malicious software or unauthorized system
access
Malicious software or unauthorized system access can
result in data loss or system unavailability.
To avoid infection of malicious software or the misuse of
the system, the following recommendations are essential:
r Customers are responsible for the security of their
local area network, especially in protecting it against
malicious software and attacks. This protection
includes a firewall, to separate the device from
uncontrolled networks, as well as measures that
ensure that the connected network is free of malicious
code.
r Make sure that any necessary third-party software is
kept up-to-date.
r Use an appropriate and up-to-date anti-virus and
anti-malware software on the PC where the utility
channel software is running.
r Enable the Data Execution Prevention (Windows
security feature) on the client system for the utility
channel software.
r Do not connect any untrusted external storage
devices (such as USB flash drives or external hard
drives) to the system.
Skin inflammation or injury Direct contact with reagents, detergents, cleaning
solutions, or other working solutions may cause skin
irritation, inflammation, or burns.
r When you handle reagents, exercise the precautions
required for handling reagents.
r Wear appropriate personal protective equipment.
r Observe the instructions given in the Instructions for
Use.
r Observe the information given in Material Safety Data
Sheets (available for Roche Diagnostics reagents and
cleaning solutions).
r If reagents, detergents, or other cleaning solutions
come into contact with your skin, wash the affected
area immediately with soap and water and apply a
disinfectant.
Consult a physician.
Roche Diagnostics
cobas omni Utility Channel IVD · User Assistance · Version 1.0
Operation
1 Operation software
Roche Diagnostics
cobas omni Utility Channel IVD · User Assistance · Version 1.0
15
Table of contents
Operation software 1
In this chapter
1
Workflows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Test development workflow. . . . . . . . . . . . . . . . . . . 17
Routine workflow . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Utility channel software . . . . . . . . . . . . . . . . . . . . . . . . . 19
Compatible system software . . . . . . . . . . . . . . . . . . 19
About the user interface . . . . . . . . . . . . . . . . . . . . . 20
Creating an unpublished UC analysis package . . 20
Opening an unpublished UC analysis package . . 21
About pipetting profiles . . . . . . . . . . . . . . . . . . . . . . 22
Defining and editing a UC analysis package . . . . 23
Publishing a UC analysis package . . . . . . . . . . . . . 26
Creating a new package from a published UC
analysis package . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Opening a published UC analysis package to
write to a reagent cassette RFID tag . . . . . . . . . . . 28
RFID reader/writer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
About the RFID reader/writer . . . . . . . . . . . . . . . . . 30
Reading and writing on an RFID tag . . . . . . . . . . . 30
Installing a UC analysis package onto the system. . . 33
Importing and installing a UC analysis package
onto the system via remote connection. . . . . . . . . 33
Uninstalling a UC analysis package from the
system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Reinstalling a UC analysis package onto the
system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Preparing the reagent cassette. . . . . . . . . . . . . . . . . . . 38
About the reagent kit . . . . . . . . . . . . . . . . . . . . . . . . 38
Preparing the master mix reagent 2. . . . . . . . . . . . 39
Filling the reagent cassette . . . . . . . . . . . . . . . . . . . 41
Quick reference: Preparing the reagent cassette. 44
Performing and viewing tests . . . . . . . . . . . . . . . . . . . . 45
Performing a utility channel test. . . . . . . . . . . . . . . 45
About viewing test results . . . . . . . . . . . . . . . . . . . . 46
1 Operation software
Roche Diagnostics
cobas omni Utility Channel IVD · User Assistance · Version 1.0
16
Table of contents
1 Operation software
Roche Diagnostics
cobas omni Utility Channel IVD · User Assistance · Version 1.0
Operation software 17
Workflows
In this section
Test development workflow (17)
Routine workflow (18)
Test development workflow
u Related topics
• Optimization software (49)
Utility channel software RFID reader/writer Reagent cassette
cobas
®
6800/8800
Systems
1
Create analysis
package
2 Write reagent
cassette ID and lot
No. to RFID tag
3 Install analysis
package to analytic
system
4 Prepare reagent
cassette and load
onto analytic
system
5 Perform test
6 Receive test results
1 Operation software
Roche Diagnostics
cobas omni Utility Channel IVD · User Assistance · Version 1.0
18 Workflows
Routine workflow
For use when the UC analysis package is already installed
on the system.
u Related topics
• Optimization software (49)
Utility channel software RFID reader/writer Reagent cassette
cobas
®
6800/8800
Systems
1
Open published
analysis package
2 Write reagent
cassette ID and
lot No. to RFID tag
3 Prepare reagent
cassette and load
onto the analytic
system
4 Select installed
UC test on
analytic system
5 Perform test
6 Receive test
results
1 Operation software
Roche Diagnostics
cobas omni Utility Channel IVD · User Assistance · Version 1.0
Operation software 19
Utility channel software
In this section
Compatible system software (19)
About the user interface (20)
Creating an unpublished UC analysis package (20)
Opening an unpublished UC analysis package (21)
About pipetting profiles (22)
Defining and editing a UC analysis package (23)
Publishing a UC analysis package (26)
Creating a new package from a published UC analysis
package (27)
Opening a published UC analysis package to write to a
reagent cassette RFID tag (28)
Compatible system software
The following table lists the compatible versions of the
system software and the utility channel software.
q Only UC analysis packages created in a compatible
version of the utility channel software can be used and
loaded onto the system.
u Related topics
• Optimization software (49)
• Installing the software (99)
Utility channel software
version
cobas
®
6800/8800 Systems
software version
3.0 1.02
y Compatible software versions
1 Operation software
Roche Diagnostics
cobas omni Utility Channel IVD · User Assistance · Version 1.0
20 Utility channel software
About the user interface
The utility channel software user interface follows the
same design concept as the cobas
®
6800/8800 Systems.
The user interface is highly simplified and consists of only
5 panels. The panels are described in the following table:
Creating an unpublished UC analysis package
Follow this procedure to set up a new unpublished UC
analysis package.
UC analysis package A UC analysis package is a bundle of files that contain
parameters and specifications relevant for a specific test.
It provides the test definition for the robotics, calculation
packages for the result calculation, and libraries for the
plausibility calculation.
You can either create a UC analysis package from a
template or from an existing published package.
Naming Ensure that each UC analysis package has a unique name
(e.g., by adding a version to the name). It is not possible
to install analysis packages with the same name onto the
system.
Panel Description
Utility channel tool User interface home panel. The Utility channel tool panel includes a list of recently used UC analysis
packages. You can open an analysis package by choosing the icon in the list. Open an unpublished
analysis package to continue editing or open a published analysis package to write on the RFID tag.
The Utility channel tool panel also includes the following task buttons:
o Create UC analysis package from template
o Create from published UC analysis package
o Open unpublished UC analysis package
o Open published UC analysis package to write on reagent cassette RFID tag
UC analysis package The UC analysis package panel is displayed when you create or open a UC analysis package. You
can define or edit analysis package information in the following fields:
o UC analysis package name
o Reagent cassette ID
Further package definition is available by choosing the PCR profile, Parameter, and Reagent
cassette buttons. When complete, you can save or publish the package by choosing the Publish,
Save as, or Save buttons at the bottom of the panel.
PCR profile The PCR profile detail panel is displayed when you choose the PCR profile button on the UC
analysis package panel. This panel allows you to define the number of steps, temperature, and hold
time during the pre-PCR, first measurement, and second measurement phases of PCR.
Parameter The Parameter detail panel is displayed when you choose the Parameter button on the UC analysis
package panel. This panel allows you to define the sample material, processing volume, number of
channels (including target name and sensitivity), and an optional internal control validation. If
selected, the internal control validation includes definitions for positive target confirmation with or
without IC, lower and upper Ct limits, and sensitivity.
Reagent cassette The Reagent cassette detail panel is displayed when you choose the Reagent cassette button on
the UC analysis package panel. This panel allows you to read data from, or write data on, an RFID
tag.
y Description of the user interface panels
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Roche cobas 5800 User manual

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