Roche cobas infinity POC Add-on User guide

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.

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

Roche Diagnostics

cobas® infinity POC remote access · Software version 1.0 · User Guide · Publication version 1.0

Safety

1 Safety information .................................................................................................. 13

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

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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

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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