cobas
®
infinity POC remote access
User Guide
Publication version 1.0
Software version 1.0
Roche Diagnostics
cobas® infinity POC remote access · Software version 1.0 · User Guide · Publication version 1.0
2
Publication information
Edition notice
This publication is intended for users of the cobas
®
infinity POC remote access application.
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.
Images The screenshots in this publication have been added
exclusively for illustration purposes. Configurable and
variable data in screenshots, such as tests, results, or
path names visible therein must not be used for
laboratory purposes.
Warranty Any customer modification to the system 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 © 2018, F. Hoffmann-La Roche Ltd. All rights reserved.
Publication version Software version Revision date Change description
0.1 1.0 September 2018 First version, only used for performance evaluation
1.0 1.0 October 2018 First market version, replacing performance
evaluation use and symbol by CE IVD markings
y Revision history
Roche Diagnostics
cobas® infinity POC remote access · Software version 1.0 · User Guide · Publication version 1.0
3
License information
The cobas
®
infinity POC remote access is protected by
contract law, copyright laws, and international treaties.
The cobas
®
infinity POC remote access is licensed for
use between F. Hoffmann-La Roche Ltd. and a licensee,
and only users authorized there under are permitted to
access and use the software. Unauthorized use and
distribution may result in civil and criminal penalties.
Open source and commercial software
cobas
®
infinity POC remote access might contain
components or modules of Open source or commercial
software programs
For copyright and other notices and licensing information
regarding such software programs included with cobas
®
infinity POC remote access please see the Licenses
folder in cobas
®
infinity POC remote access installation.
This product and the cobas
®
infinity POC remote access
as a whole may form a regulated device in accordance
with the applicable laws - please refer to the user manual
and the labeling for details. Please note that the
respective authorization in accordance with the
applicable laws lapse in case of any unauthorized
changes to the cobas
®
infinity POC remote access.
Trademarks COBAS INFINITY is a trademark of Roche.
Other product names and 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
The cobas
®
infinity POC remote access application
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.
Compliance with the applicable directive(s) is provided by
means of the Declaration of Conformity.
The following marks demonstrate compliance:
Roche Diagnostics
cobas® infinity POC remote access · Software version 1.0 · User Guide · Publication version 1.0
4
Contact addresses
For in vitro diagnostic use
Complies with the provisions of the applicable EU
directives.
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Switzerland
Distributed in USA by:
Roche Diagnostics
9115 Hague Road
Indianapolis, Indiana
USA
Table of contents 5
Roche Diagnostics
cobas® infinity POC remote access · Software version 1.0 · User Guide · Publication version 1.0
Table of contents
Publication information 2
Contact addresses 4
Table of contents 5
Intended use 7
Intended users 7
Symbols and abbreviations 7
Safety
1 Safety information
Safety classifications 15
System safety 16
Safety information for IT managers 17
Operation
2 Overview
Features and Functionalities 25
User interface software specifications 26
Supported POC devices 27
3 Using cobas
®
infinity POC remote access
Managing POC devices 31
Using the User Assistance 46
Opening the About box 47
Troubleshooting 48
Appendix
Index 51
6 Table of contents
Roche Diagnostics
cobas® infinity POC remote access · Software version 1.0 · User Guide · Publication version 1.0
Roche Diagnostics
cobas® infinity POC remote access · Software version 1.0 · User Guide · Publication version 1.0
7
Intended use
The cobas
®
infinity POC remote access software is
intended to be used by professional personnel to
remotely manage blood gas analysers.
The cobas
®
infinity POC remote access software allows
operators to remotely troubleshoot the blood gas
analysers installed within the Point-of-Care environment
in real time.
The software is not intended for the diagnosis, screening,
monitoring or treatment of patients.
Intended users
The cobas
®
infinity POC remote access software is
intended for the following user groups.
Symbols and abbreviations
Symbols used in the publication
User group Description of use
POC coordinator
(POCC)
o Screen sharing for purpose of
trouble shooting connected
analysers
o Perform maintenance of
connected analysers by
initiating remote commands
y Primary users
User group Description of use
Technical / Field Service
Representative
(analyser)
o Trouble shooting by using
screen sharing
o Maintenance of connected
analysers by initiating remote
commands
Field Service
Representative
(software)
o Installation and configuration
of cobas
®
infinity POC
remote access
y Other users (not primary users / target customer)
Symbol Explanation
o List item
u Related topics containing further information.
q
Tip. Extra information on correct use or useful
hints.
y Symbols used in the publication
Roche Diagnostics
cobas® infinity POC remote access · Software version 1.0 · User Guide · Publication version 1.0
8
Product name Except where the context clearly indicated otherwise, the
following product names and descriptors are used.
Symbols used on the product
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
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
Product name Descriptor
cobas
®
infinity POC remote
access
remote access
(1)
(1) Descriptor used in this publication
POC remote access
(2)
(2) Descriptor displayed in the user interface
cobas b 123 POC system
POC device
(3)
(3) The descriptor "POC device" only refers to the cobas b 123 POC
system or cobas b 221 POC system.
cobas b 221 POC system POC device
y
Symbol Explanation
Catalogue number
Global Trade Item Number
For in vitro diagnostic use
y Symbols used on the product
Roche Diagnostics
cobas® infinity POC remote access · Software version 1.0 · User Guide · Publication version 1.0
9
Abbreviations The following abbreviations are used.
Complies with the provisions of the applicable
EU directives.
Date of manufacture
Manufacturer
Consult instructions for use
Symbol Explanation
y Symbols used on the product
Abbreviation Definition
ANSI American National Standards
Institute
IVD In Vitro Diagnostic
OTSS Off-the-shelf software
PC Personal Computer
POC Point of Care
POCC Point of Care Coordinator
URL Uniform Resource Locator
UTF-8 8-Bit UCS Transformation Format
y Abbreviations
Roche Diagnostics
cobas® infinity POC remote access · Software version 1.0 · User Guide · Publication version 1.0
10
1 Safety information
Roche Diagnostics
cobas® infinity POC remote access · Software version 1.0 · User Guide · Publication version 1.0
13
Table of contents
Safety information 1
In this chapter
1
Safety classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
System safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Safety information for IT managers . . . . . . . . . . . . . . . 17
1 Safety information
Roche Diagnostics
cobas® infinity POC remote access · Software version 1.0 · User Guide · Publication version 1.0
14
Table of contents
1 Safety information
Roche Diagnostics
cobas® infinity POC remote access · Software version 1.0 · User Guide · Publication version 1.0
Safety classifications 15
Safety classifications
The safety information applies to the system and is listed
in accordance with ANSI Z535.6-2011. The Danger safety
classification to indicate a situation that results in injury
or death is not applicable to this system and is therefore
not listed.
WARNING
!
Warning
r Indicates a potentially dangerous situation which, if
ignored, may lead to fatal or severe injuries.
CAUTION
!
Caution
r Indicates a potentially dangerous situation which, if
ignored, may lead to injuries and/or damage to
property.
NOTICE
NOTICE
r Indicates a message not related to personal injury.
1 Safety information
Roche Diagnostics
cobas® infinity POC remote access · Software version 1.0 · User Guide · Publication version 1.0
16 System safety
System safety
Failure to observe the safety information may result in
incorrect results, data corruption, and data losses.
CAUTION
!
Incorrect or corrupt data due to unauthorized
access
Data security is breached if unauthorized users have
access to your user name and password.
r Use strong passwords.
r Do not use static passwords.
r Always enter your password unobserved.
r Do not write down your password.
r Never write down the password in a contact form, in
an address book or in a file on the computer.
r Do not disclose your password to anyone. Roche
never asks you for your password.
r If you ever disclose your password to anyone, change
it immediately after.
r If you think anyone else has access to your account,
contact your Roche Service representative
immediately.
CAUTION
!
Sharing of user accounts not allowed
Any activity on the system is traceable and the user who
performed it should be identifiable.
r Do not use shared user accounts.
1 Safety information
Roche Diagnostics
cobas® infinity POC remote access · Software version 1.0 · User Guide · Publication version 1.0
Safety information for IT managers 17
Safety information for IT managers
The IT manager of your organization should ensure that
the following safety measures are implemented.
Data security
CAUTION
!
Monitor the system for suspicious activity and
report suspected compromise
If you find any signs of malicious software or
unauthorized access to the system (unexpected warning
messages, files, or log entries like multiple failed logon
attempts; significantly degraded user interface
performance; seemingly random crashes of the system;
automated typing of text; and so on), the following
recommendations are essential:
r Physically disconnect the system from the network.
r Contact the IT responsible in your organization to
report and verify the finding.
r Mistrust results produced while the system has been
compromised.
r Contact your Roche Service representative to initiate
the system recovery.
WARNING
!
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 by malicious software or the
unauthorized access and misuse of the system, the
following recommendations are essential:
r Make sure other computers and services on the
network (for example, the LIS, archiving share, backup
share, or service) are properly secured and protected
against malicious software and unauthorized access.
r Restrict physical access to the system and all attached
IT infrastructure (computer, cables, network
equipment, and so on).
1 Safety information
Roche Diagnostics
cobas® infinity POC remote access · Software version 1.0 · User Guide · Publication version 1.0
18 Safety information for IT managers
r Check all external storage devices, like CDs, DVDs, or
USB mass storage devices with an anti-virus scanner
(on another computer) to ensure that they are free of
malicious software, before using them on the system.
r Use state-of-the-art security mechanisms (e.g. WPA2
EAP) to protect Wi-Fi connections.
r Allow only defined users to read and write encryption
keys.
r Allow only internet access to trusted web sites and
web services.
r Enable Data Execution Prevention for all applications
(Windows Server).
r Define permissions for user- and technical accounts
in the operating system according the principles of
least privilege and segregation of duties.
r Make sure to use secure channels to download
software updates of the system.
r Set up monitoring mechanisms to ensure that the web
services are up and running.
r Monitor OTSS components in the system for security
vulnerabilities and log suspicious events.
r If OTSS is not deployed as part of the software release
of the product, deploy up-to-date versions of OTSS
with product releases.
CAUTION
!
No additional protection against malicious software
and hacker attacks provided with the product
Customers are responsible for the IT security of their IT
infrastructure and for protecting it against malicious
software and hacker attacks. This protection might
include a firewall to separate the device from
uncontrolled networks or measures that ensure that the
connected network is free of malicious code. Failure to do
so may result in data loss or render the product unusable.
r Ensure that the product protection against malicious
software and hacker attacks is sufficient.
r Roche recommends protecting corresponding
computers and mobile devices against harmful
software using an antivirus software. If problems
occur, contact your Roche Service representative.
1 Safety information
Roche Diagnostics
cobas® infinity POC remote access · Software version 1.0 · User Guide · Publication version 1.0
Safety information for IT managers 19
CAUTION
!
Unauthorized deletion of audit log
Unauthorized deletion of the audit log can lead to loss of
regulatory compliance due to unavailability of data
required to reconstruct and examine system events.
r Define the proper roles and policies to prevent
unauthorized users from deleting the audit log.
OTSS updates
NOTICE
Automatic update of OTSS
Roche recommends automatic updates of OTSS that is
not deployed as part of the product release unless your
Roche Service representative instructs you otherwise.
Automatic OTSS updates can affect performance of the
system.
r Ensure that automatic OTSS updates to not affect
system performance.
1 Safety information
Roche Diagnostics
cobas® infinity POC remote access · Software version 1.0 · User Guide · Publication version 1.0
20 Safety information for IT managers
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