Roche cobas infinity POC Add-on User manual

cobas

®

infinity POC tablet

User Assistance for iOS

Publication version 2.0

Software version 1.1

Roche Diagnostics

cobas infinity POC tablet · Software version 1.1 · User Assistance for iOS · Publication version 2.0

2

Publication information

Edition notice

This publication is intended for users of the cobas

®

infinity POC tablet.

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

cobas

®

infinity POC tablet contains all information

about the product, including the following:

• Safety

• Setting up the app

• Getting started

• Managing devices

• Managing operators

• Managing certification statuses

• Managing QC results

• Background information

cobas

®

infinity POC tablet help overlays are embedded

in the app. They are intended as an instruction for

performing a task for the first time and can be enabled to

be displayed again.

!

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.

Publication

version

Software version Revision date Change description

1.0 1.0 December 2016 First version

2.0 1.1 August 2017 App requirements updated, improvements in QC views, and

new app features added (operator’s locations management,

barcode scanning, unassigned devices, reports, and User

Assistance).

u What is new in publication version 2.0 (8)

y Revision history

Roche Diagnostics

cobas infinity POC tablet · Software version 1.1 · User Assistance for iOS · Publication version 2.0

3

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.

reserved.

License information

cobas

®

infinity POC tablet software is protected by

contract law, copyright law, and international treaties.

cobas

®

infinity POC tablet 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

cobas

®

infinity POC tablet may include components or

modules that are commercial or open-source software.

For copyright and other notices and licensing information

regarding such software programs, see the electronic

distribution included with this product.

cobas

®

infinity POC tablet as a whole may form a device

regulated in accordance with applicable laws. For more

detailed information, refer to the user guide and labeling.

Please note that the respective authorization in

accordance with applicable laws lapses in case of any

unauthorized changes to cobas

®

infinity POC tablet.

Trademarks The following trademarks are acknowledged:

• ROCHE, ROCHE OMNI, ACCU-CHEK, COBAS B,

COBAS, and LIFE NEEDS ANSWERS are trademarks of

Roche.

• Roche and the Roche symbol are registered

trademarks of the Roche group.

All other trademarks are the property of their respective

owners.

Roche Diagnostics

cobas infinity POC tablet · Software version 1.1 · User Assistance for iOS · Publication version 2.0

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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.

Languages To change the language of the app, you must change the

language settings of your tablet. If a language is not

supported, the app reverts to English.

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 tablet app.

The complete list of Roche Diagnostics and third-party

products available for use with the cobas

®

infinity POC

tablet 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 tablet app

in the US.

Contact addresses

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Switzerland

Distributed by Roche Diagnostics

9115 Hague Road

Indianapolis

Indiana

USA

Table of contents 5

Roche Diagnostics

cobas infinity POC tablet · Software version 1.1 · User Assistance for iOS · Publication 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

Safety

1 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 39

3 Using the app

Getting started 45

Managing devices 49

Managing operators 58

Managing certifications 64

Managing QC results 70

Managing reports 82

Appendix

4 Glossary

Index 95

6 Table of contents

Roche Diagnostics

cobas infinity POC tablet · Software version 1.1 · User Assistance for iOS · Publication version 2.0

Roche Diagnostics

cobas infinity POC tablet · Software version 1.1 · User Assistance for iOS · Publication version 2.0

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Intended use

The cobas

®

infinity POC tablet is an app for managing

professional Point of Care testing. It is an app that is

intended to be connected with the cobas IT 1000

application software, which collects POC results and

associated data. The cobas IT 1000 application software

automatically receives data from POC devices and

delivers this data to a server application that can be

accessed via the cobas

®

infinity POC tablet app via the

hospital's network for review by professional personnel.

The professional personnel can see an overview of the

system, device status, operator status, certification status,

QC results, and generate reports. Patient data is not

accessible from the cobas

®

infinity POC tablet app. The

goal of the app is to provide users with the ability to

complete tasks while away from their desk using their

tablet devices.

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 tablet

app

cobas IT 1000 application software

cobas

®

infinity POC mobile

app

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 tablet · Software version 1.1 · User Assistance for iOS · Publication version 2.0

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Abbreviations The following abbreviations are used.

What is new in publication version 2.0

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

operator.

u Viewing operator details (58)

u Editing operator details (61)

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

u Adding an operator (59)

u List of supported barcodes (29)

Requirements update The app requirements have been updated.

u List of app requirements (26)

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

location and assign them.

u Viewing and adding unassigned devices (57)

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)

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

iOS Operating system for Apple mobile

devices

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 tablet · Software version 1.1 · User Assistance for iOS · Publication version 2.0

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Reports You can create, review, sign, and export QC results

reports.

u Managing reports (82)

User Assistance You can find support information integrated in the app.

u Using the User Assistance (40)

All QC results listed You can also see accepted and rejected results in the QC

results panel.

u About QC results (71)

Roche Diagnostics

cobas infinity POC tablet · Software version 1.1 · User Assistance for iOS · Publication version 2.0

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Roche Diagnostics

cobas infinity POC tablet · Software version 1.1 · User Assistance for iOS · Publication version 2.0

Safety

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

1 Safety information

Roche Diagnostics

cobas infinity POC tablet · Software version 1.1 · User Assistance for iOS · Publication version 2.0

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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

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cobas infinity POC tablet · Software version 1.1 · User Assistance for iOS · Publication version 2.0

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Table of contents

1 Safety information

Roche Diagnostics

cobas infinity POC tablet · Software version 1.1 · User Assistance for iOS · Publication version 2.0

Safety information 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 tablet · Software version 1.1 · User Assistance for iOS · Publication 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 On Android devices, 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 Safety information

Roche Diagnostics

cobas infinity POC tablet · Software version 1.1 · User Assistance for iOS · Publication version 2.0

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

!

Recommended installation for the adapter

To avoid vulnerabilities due to unencrypted

communication between the adapter and the cobas IT

1000 application software:

r Install the adapter on the same server where the

cobas IT 1000 application software is running.

r If you cannot install the adapter on the same server as

the cobas IT 1000 application software, ensure that

both applications are running in a secure

environment.

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 Safety information

Roche Diagnostics

cobas infinity POC tablet · Software version 1.1 · User Assistance for iOS · Publication 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 Wi-Fi 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 antivirus

software. Therefore, 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 tablet · Software version 1.1 · User Assistance for iOS · Publication version 2.0

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 Safety information

Roche Diagnostics

cobas infinity POC tablet · Software version 1.1 · User Assistance for iOS · Publication 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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