Roche cobas infinity POC Add-on User guide

cobas

®

infinity POC remote access

User Guide

Publication version 1.1

Software version 1.0.1

Roche Diagnostics

cobas® infinity POC remote access · Software version 1.0.1 · User Guide · Publication version 1.1

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.

Where to find information The User Assistance contains all information about the

product, including the following:

• Routine operation

• Maintenance

• Safety

• Troubleshooting information

• A software reference

• Configuration information

• Background information

The Safety Guide contains important safety information.

You must read the Safety Guide before operating the

instrument.

The User Guide focuses on routine operation and

maintenance. The chapters are organized according to

the normal operation workflow.

Privacy notice

When you use User Assistance online, viewing events

(topics viewed and searches performed) and IP addresses

are logged.

The data collected is for Roche internal use only and is

never forwarded to third parties. It is anonymized, and

after one year it is automatically deleted.

Viewing events are analyzed to improve User Assistance

content and search functionality. IP addresses are used to

classify regional behavior.

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

1.1 1.0.1 February 2021 u What is new in publication version 1.1 (12)

y Revision history

Roche Diagnostics

cobas® infinity POC remote access · Software version 1.0.1 · User Guide · Publication version 1.1

3

!

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.

!

Incident reporting

r Inform your Roche representative and your local

competent authority about any serious incidents

which may occur when using this product.

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 images in this publication have been added

exclusively for illustration purposes. Configurable and

variable data in screenshots, such as tests, results, or

path names visible therein must not be used for

laboratory purposes.

Warranty Any customer modification to the system 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.

reserved.

License information

The cobas

®

infinity POC remote access is protected by

contract law, copyright laws, and international treaties.

The cobas

®

infinity POC remote access contains a user

license between F. Hoffmann-La Roche Ltd. and a license

holder, and only authorized users may access the

software and use it. Unauthorized use and distribution

may result in civil and criminal penalties.

Roche Diagnostics

cobas® infinity POC remote access · Software version 1.0.1 · User Guide · Publication version 1.1

4

Open source and commercial software

cobas

®

infinity POC remote access 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

®

infinity POC remote access, refer to the electronic

distribution included with this product.

This open source and commercial software and cobas

®

infinity POC remote access as a whole can constitute a

device regulated in accordance with applicable law. For

more detailed information, refer to the corresponding

user documentation and labeling.

Note that the respective authorization is no longer valid

according to the corresponding legislation should any

unauthorized changes be made to cobas

®

infinity POC

remote access.

Trademarks COBAS INFINITY is a trademark 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

The cobas

®

infinity POC remote access application

meets the requirements laid down in:

Regulation (EU) 2017/746 of the European Parliament and

of the Council of 5 April 2017 on in vitro diagnostic

medical devices and repealing Directive 98/79/EC and

Commission Decision 2010/227/EU.

Compliance with the applicable directive(s) is provided by

means of the Declaration of Conformity.

The following marks demonstrate compliance:

For in vitro diagnostic use

Regulation (EU) 2017/746 of the European Parliament

and of the Council of 5 April 2017 on in vitro diagnostic

medical devices and repealing Directive 98/79/EC and

Commission Decision 2010/227/EU.

Roche Diagnostics

cobas® infinity POC remote access · Software version 1.0.1 · User Guide · Publication version 1.1

5

Contact addresses

Roche affiliates A list of all Roche affiliates can be found at:

www.roche.com/about/business/roche_worldwide.htm

eLabDoc Electronic user documentation can be downloaded using

the eLabDoc e-service on Dialog:

www.dialog.roche.com

For more information, contact your local affiliate or Roche

Service representative.

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Switzerland

Distributed in USA by:

Roche Diagnostics

9115 Hague Road

Indianapolis, Indiana

USA

Roche Diagnostics

cobas® infinity POC remote access · Software version 1.0.1 · User Guide · Publication version 1.1

6

Table of contents 7

Roche Diagnostics

cobas® infinity POC remote access · Software version 1.0.1 · User Guide · Publication version 1.1

Table of contents

Publication information 2

Contact addresses 5

Table of contents 7

Intended use 9

Intended users 9

Symbols and abbreviations 9

What is new in publication version 1.1 12

Safety

1 Safety information

Safety classifications 17

System safety 18

Safety information for IT managers 19

Privacy protection 22

Operation

2 Overview

Features and Functionalities 27

User interface software specifications 28

Supported POC devices 29

3 Using cobas

®

infinity POC remote access

Managing POC devices 33

Using the User Assistance 47

Opening the About box 48

Troubleshooting 49

Appendix

Index 53

8 Table of contents

Roche Diagnostics

cobas® infinity POC remote access · Software version 1.0.1 · User Guide · Publication version 1.1

Roche Diagnostics

cobas® infinity POC remote access · Software version 1.0.1 · User Guide · Publication version 1.1

9

Intended use

The cobas

®

infinity POC remote access software is

intended to be used by professional personnel to

remotely manage blood gas analyzers.

The cobas

®

infinity POC remote access software allows

operators to remotely troubleshoot the blood gas

analyzers 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

troubleshooting connected

analyzers

o Perform maintenance of

connected analyzers by

initiating remote commands

y Primary users

User group Description of use

Roche Service

representative (analyzer)

o Troubleshooting by using

screen sharing

o Maintenance of connected

analyzers by initiating remote

commands

Roche 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 1.0.1 · User Guide · Publication version 1.1

10

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

application

(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 system.

cobas b 221 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 1.0.1 · User Guide · Publication version 1.1

11

Abbreviations The following abbreviations are used.

Complies with the provisions of the applicable

EU directives.

Date of manufacture

Manufacturer

Consult instructions for use

Unique device identifier

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 1.0.1 · User Guide · Publication version 1.1

12

What is new in publication version 1.1

Regulatory adaptations The following information was added as part of the

adaptation to the EU regulation 2017/746 on in vitro

diagnostic medical devices:

• Information about incident reporting

• Link to the worldwide list of Roche affiliates

• Unique device identifier symbol

u Publication information (p. 2)

u Roche affiliates (p. 5)

u Symbols used on the product (p. 10)

Open source and commercial software Some statements in the section "Open source and

commercial software" have been updated.

u Open source and commercial software (4)

General data privacy A statement about privacy protection has been added.

u Privacy protection (22)

Specifications The user interface specifications have been updated.

u User interface software specifications (28)

Roche Diagnostics

cobas® infinity POC remote access · Software version 1.0.1 · User Guide · Publication version 1.1

Safety

1 Safety information .................................................................................................. 15

1 Safety information

Roche Diagnostics

cobas® infinity POC remote access · Software version 1.0.1 · User Guide · Publication version 1.1

15

Table of contents

Safety information 1

In this chapter

1

Safety classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

System safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Safety information for IT managers . . . . . . . . . . . . . . . 19

Privacy protection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

1 Safety information

Roche Diagnostics

cobas® infinity POC remote access · Software version 1.0.1 · User Guide · Publication version 1.1

16

Table of contents

1 Safety information

Roche Diagnostics

cobas® infinity POC remote access · Software version 1.0.1 · User Guide · Publication version 1.1

Safety classifications 17

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

r Indicates a message not related to personal injury.

1 Safety information

Roche Diagnostics

cobas® infinity POC remote access · Software version 1.0.1 · User Guide · Publication version 1.1

18 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 1.0.1 · User Guide · Publication version 1.1

Safety information for IT managers 19

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 1.0.1 · User Guide · Publication version 1.1

20 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.

Page is loading ...

Roche cobas infinity POC Add-on User guide

Roche cobas infinity POC Add-on User guide

Related papers

Other documents