Roche cobas infinity POC Add-on User manual

cobas

®

infinity POC mobile

User Guide for iOS version 2.0

Software version 1.2.0

Roche Diagnostics

cobas infinity POC mobile · Software version 1.2.0 · User Guide for iOS · version 2.0

2

Publication information

Edition notice

This publication is intended for users of the cobas

®

infinity POC mobile app.

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 and hardware 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.

Publication

version

Software version Revision date Change description

1.0 1.0.0 April 2015 First version

1.1 1.1.0 December 2015 Software and document updates

1.2 1.1.0 July 2016 Minor document updates

2.0 1.2.0 March 2017 New document layout and software updates

u What is new in publication version 2.0 (8)

y Revision history

Roche Diagnostics

cobas infinity POC mobile · Software version 1.2.0 · User Guide for iOS · version 2.0

3

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 mobile app is protected by

contract law, copyright law, and international treaties. The

cobas

®

infinity POC mobile app 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.

Open Source and Commercial Software

The cobas

®

infinity POC mobile app 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 the

cobas

®

infinity POC mobile app, refer to the electronic

distribution included with this product.

This open source and commercial software and the

cobas

®

infinity POC mobile app 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 the cobas

®

infinity POC mobile app.

Trademarks The following trademarks are acknowledged:

ROCHE, ROCHE OMNI, ACCU-CHEK, COBAS, COBAS

INFINITY, COBAS B, 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.

Roche Diagnostics

cobas infinity POC mobile · Software version 1.2.0 · User Guide for iOS · version 2.0

4

Disclaimer This User Guide may contain information and references

to products that may not be available in your country or

sold by Roche Diagnostics. This User Guide makes no

claims regarding the use or performance of those

products. Selected third-party products are available for

use with the cobas

®

infinity POC mobile app.

The complete list of Roche Diagnostics and third-party

products available for use with the cobas

®

infinity POC

mobile app in the US can be found at

http://usdiagnostics.roche.com/cobasITdevices.

Other Roche Diagnostics or third-party products listed

within the software or manuals which are not listed at

http://usdiagnostics.roche.com/cobasITdevices are not

available for use with the cobas

®

infinity POC mobile

app in the US.

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

Table of contents 5

Roche Diagnostics

cobas infinity POC mobile · Software version 1.2.0 · User Guide for iOS · version 2.0

Table of contents

Publication information 2

Contact addresses 4

Table of contents 5

Intended use 7

Symbols and abbreviations 7

What is new in publication version 2.0 8

What is new in publication version 1.2 9

Safety

1 General safety information

Safety classifications 15

System safety 16

Safety information for IT managers 17

Operation

2 Overview of the app

About the app 25

List of app requirements 26

About the intended users 27

List of user profiles 28

List of supported barcodes 29

Setting up the app 31

Getting help 40

3 Using the app

Getting started 45

Managing devices 50

Managing operators 63

Managing certifications 78

Appendix

4 Glossary

Index 87

6 Table of contents

Roche Diagnostics

cobas infinity POC mobile · Software version 1.2.0 · User Guide for iOS · version 2.0

Roche Diagnostics

cobas infinity POC mobile · Software version 1.2.0 · User Guide for iOS · version 2.0

7

Intended use

cobas

®

infinity POC mobile is a mobile app for

managing professional Point of Care testing. It is an app

that is intended to be connected with the cobas IT 1000

application which collects POC results and associated

data. The cobas IT 1000 application automatically

receives data from POC devices and delivers this data to a

server application that can be accessed via the cobas

®

infinity POC mobile app via the hospital’s network for

review by professional personnel.

The professional personnel can see an overview of the

device status, operator status, and certification status. No

access to QC or Patient data is accessible from the

cobas

®

infinity POC mobile app. The goal of the app is

to provide users with the ability to complete tasks while

away from their desk using their mobile devices. This

results in the benefit of reduced time to complete tasks.

This product is not intended for the diagnosis, screening,

monitoring, or treatment of patients.

Symbols and abbreviations

Product names Except where the context clearly indicated otherwise, the

following product names and descriptors are used.

Symbols used in the publication

Product name Descriptor

cobas

®

infinity POC mobile

app

cobas

®

infinity POC adapter

adapter

cobas IT 1000 application application

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.

y Symbols used in the publication

Roche Diagnostics

cobas infinity POC mobile · Software version 1.2.0 · User Guide for iOS · version 2.0

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Abbreviations The following abbreviations are used.

What is new in publication version 2.0

New layout and structure Resulting from customer feedback, we have updated the

layout and the structure of this publication to help you

find information easier and perform tasks quicker.

Viewing and editing operator’s locations You can view and change the locations assigned to an

operator.

u Viewing operator details (63)

u Editing operator details (70)

Scanning operator barcode To add new operators, you can also scan their barcode.

u Adding an operator (65)

u List of supported barcodes (29)

Requirements update The app requirements have been updated.

u List of app requirements (26)

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

Abbreviation Definition

ANSI American National Standards

Institute

iOS Operating system for Apple mobile

devices

n/a not applicable

POC Point of Care

POCC Point of Care Coordinator

POCT Point of Care Testing

VPN Virtual Private Network

y Abbreviations

Roche Diagnostics

cobas infinity POC mobile · Software version 1.2.0 · User Guide for iOS · version 2.0

9

Google Analytics settings You can configure whether to send app usage

information to Google Analytics for statistical purposes.

u Changing Google Analytics settings (38)

Unassigned devices You can view which devices are not assigned yet to any

location and assign them.

u Viewing and adding unassigned devices (61)

Profile access rights Profiles can have different access rights. For users

without full access rights, some elements of the user

interface are hidden.

u List of user profiles (28)

What is new in publication version 1.2

Operators The possibility to add an operator and edit an existing

operator was added.

The possibility to update the operator's certification

criteria was added.

The option to export the list of operators who need

training to a file was added.

u Adding an operator (65)

u Editing operator details (70)

u Updating the certification status of an operator (72)

u Exporting a list of operators (75)

Certifications The possibility to view all available certifications was

added.

u Viewing the status of certifications (78)

Devices Entering the reason for change is now necessary.

u Replacing devices (57)

Version check When you access the app, it checks the compatibility of

the interface and adapter version.

u Logging on to the app (47)

Access control The following user profiles can access the app:

• POCT Admin

• POCC

• Nurse Educator

• IT Manager

• Service

u About the app (25)

Roche Diagnostics

cobas infinity POC mobile · Software version 1.2.0 · User Guide for iOS · version 2.0

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Roche Diagnostics

cobas infinity POC mobile · Software version 1.2.0 · User Guide for iOS · version 2.0

Safety

1 General safety information.................................................................................. 13

1 General safety information

Roche Diagnostics

cobas infinity POC mobile · Software version 1.2.0 · User Guide for iOS · version 2.0

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Table of contents

General safety information 1

In this chapter

1

Safety classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

System safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Safety information for IT managers . . . . . . . . . . . . . . . 17

1 General safety information

Roche Diagnostics

cobas infinity POC mobile · Software version 1.2.0 · User Guide for iOS · version 2.0

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Table of contents

1 General safety information

Roche Diagnostics

cobas infinity POC mobile · Software version 1.2.0 · User Guide for iOS · version 2.0

General safety information 15

Safety classifications

The safety precautions and important user notes are

classified according to the ANSI Z535.6 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.

CAUTION

!

Caution...

r ...indicates a hazardous situation which, 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 system.

Important information that is not safety relevant is

indicated with the following icon:

q Tip...

...indicates additional information on correct use or useful

tips.

1 General safety information

Roche Diagnostics

cobas infinity POC mobile · Software version 1.2.0 · User Guide for iOS · version 2.0

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 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

!

Handling mobile devices

Mobile devices on which the app runs must be handled

with care to ensure the app security.

r Do not allow installations of applications, extensions,

and themes from sources other than the default and

secure distribution channels for your platform (Google

Play on Android and App Store on iOS).

r Do not root or jail break your mobile device.

r Android: disable installation of applications from

untrusted sources.

r For security reasons, connect the app with your

organization only through a secured network, such as

your internal network. If you are connecting remotely,

use VPN to connect to your internal network.

1 General safety information

Roche Diagnostics

cobas infinity POC mobile · Software version 1.2.0 · User Guide for iOS · version 2.0

General safety information 17

Safety information for IT managers

The IT manager of your organization should ensure that

the following safety measures are implemented.

System safety

CAUTION

!

Sharing of user accounts not allowed

Any activity on the system should be traceable and the

user who performed it should be identifiable.

r Do not use shared user accounts.

CAUTION

!

Blocked operator access to POC devices

If the application is compromised by a malicious attacker,

operator access to connected POC devices can be

blocked. To avoid delayed results due to blocked operator

access, do the following:

r Assess the impact of availability of each connected

POC device on patient safety. If necessary, implement

suitable risk control measures or manually managed

offline devices.

Data security

CAUTION

!

Monitor the system for suspicious activity and

report suspected compromise

If you find any of the typical 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.

1 General safety information

Roche Diagnostics

cobas infinity POC mobile · Software version 1.2.0 · User Guide for iOS · version 2.0

18 Safety information for IT managers

CAUTION

!

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).

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 WiFi connections.

r Allow only defined users to read and write encryption

keys (IIS App config / Windows Server Hardening).

r Allow only internet access to trusted web sites and

web services.

r Enable Data Execution Prevention for all applications

(Windows Server).

r Make sure to use secure channels to download

software updates of the system.

CAUTION

!

Product itself not additionally protected against

malicious software and hacker attacks

The customers are responsible for 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 The app does not come with its own virus scanner.

Therefore, Roche recommends protecting

corresponding computers and mobile devices against

harmful software using a virus scanner. If problems

occur, contact your Roche Service representative.

1 General safety information

Roche Diagnostics

cobas infinity POC mobile · Software version 1.2.0 · User Guide for iOS · version 2.0

General safety information 19

CAUTION

!

Cryptographic protocol

The HTTPS protocol is used for a secure communication

between the app and the server. Using the proper HTTPS

protocol ensures privacy and data integrity.

r Enable TLS version 1.2 on the server where the

adapter is installed.

1 General safety information

Roche Diagnostics

cobas infinity POC mobile · Software version 1.2.0 · User Guide for iOS · version 2.0

20 Safety information for IT managers

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Roche cobas infinity POC Add-on User manual

Roche cobas infinity POC Add-on User manual

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