Roche cobas infinity POC Add-on User manual

cobas

®

infinity POC tablet

Software version 1.0.0

User Guide for Android

Version 1.0

Roche Diagnostics

cobas® infinity POC tablet · Software version 1.0.0 · User Guide for Android · Version 1.0

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 training 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.

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.

Publication

version

Software version Revision date Change description

1.0 1.0.0 December 2016 First version

y Revision history

Roche Diagnostics

cobas® infinity POC tablet · Software version 1.0.0 · User Guide for Android · Version 1.0

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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.

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.

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

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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 or to the preferred

language of the tablet.

Contact addresses

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Switzerland

Distributed by Roche Diagnostics

9115 Hague Road

Indianapolis

Indiana

USA

Roche Diagnostics

cobas® infinity POC tablet · Software version 1.0.0 · User Guide for Android · Version 1.0

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T

able of contents

Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Symbols and abbreviations . . . . . . . . . . . . . . . . . . . 7

Safety information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Safety classifications . . . . . . . . . . . . . . . . . . . . . . . . 9

System safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Data security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Open source and third-party software . . . . . . . . . 14

Setting up the app . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

List of software and hardware requirements . . . . 16

Installing the app . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

17

Configuring the server address . . . . . . . . . . . . . . . 18

Configuring the app settings . . . . . . . . . . . . . . . . . 19

About device settings. . . . . . . . . . . . . . . . . . . . . 20

Changing the device settings . . . . . . . . . . . . . . 21

Changing auto log off settings . . . . . . . . . . . . . 24

Changing Google analytics settings. . . . . . . . . 25

Getting started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

About cobas® infinity POC tablet . . . . . . . . . . . . . 27

About user accounts and passwords. . . . . . . . . . . 29

Logging on . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Logging off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

List of touch gestures . . . . . . . . . . . . . . . . . . . . . . . 33

Getting help. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Enabling help overlays . . . . . . . . . . . . . . . . . . . . 34

Accessing the user guide . . . . . . . . . . . . . . . . . 35

Managing devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

About devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Checking device statuses . . . . . . . . . . . . . . . . . . . . 41

Replacing devices. . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Relocating devices . . . . . . . . . . . . . . . . . . . . . . . . . . 47

Editing devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Managing operators. . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

About operators . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

Adding operators . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Editing operator details . . . . . . . . . . . . . . . . . . . . . . 57

Checking trainings status . . . . . . . . . . . . . . . . . . . . 59

About the Certifications view . . . . . . . . . . . . . . 60

Checking operator trainings status . . . . . . . . . 61

Checking training status for a device . . . . . . . 63

Updating training status . . . . . . . . . . . . . . . . . . . . . 64

Updating operator training status. . . . . . . . . . . 65

Updating training status for a device

certification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67

Exporting operators who need training . . . . . . 69

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Managing QC results . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

About QC results . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

Reviewing results . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

Rejecting results . . . . . . . . . . . . . . . . . . . . . . . . . 79

Accepting results . . . . . . . . . . . . . . . . . . . . . . . . 80

Roche Diagnostics

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Preface

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 cobas IT 1000, which

collects POC results and associated data. The cobas IT

1000 system 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 device status,

operator status, certification status and QC results.

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. The cobas

®

infinity POC

tablet supports devices and operators workflows

supported by the cobas

®

infinity POC mobile app and in

addition the tablet app supports quality control workflows

to enable the management of quality control results.

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

software

cobas IT 1000 application software

cobas

®

infinity POC mobile

software

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

y Symbols used in the publication

Roche Diagnostics

cobas® infinity POC tablet · Software version 1.0.0 · User Guide for Android · Version 1.0

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Abbreviations The following abbreviations are used.

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.

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

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Safety information

In this section

Safety classifications (9)

System safety (10)

Data security (12)

Open source and third-party software (14)

Safety classifications

The safety information applies to the system and is listed

in accordance with ANSI Z535.6-2006. 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.

Roche Diagnostics

cobas® infinity POC tablet · Software version 1.0.0 · User Guide for Android · Version 1.0

10 Safety information

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 incorrect operation

or the use of wrong modules

If the devices on which the system is running operate

inefficiently or are misused, the system data may become

corrupt.

r Use only computers, monitors, printers, and

accessories recommended by the manufacturer.

r Service your computer regularly:

o Defragment the hard disk.

o Delete old, unused backups in order to keep disk

space available.

o Install, run, and update antivirus software.

o Check for system error entries in the warning

display.

r Reboot the servers after a change of timezone.

CAUTION

!

Corrupt data due to malicious software

The security of the system and its data depends on its

protection against malicious software. If the instruments

on which the system operates become infected with

malicious software, it could compromise the security of

the system.

r Install a firewall, maintain up-to-date antivirus

software, and keep your system up to date.

r Configure a firewall to allow instruments and

information systems to connect with the modules of

the cobas

®

infinity POC tablet solution.

CAUTION

!

Unstable system behavior due to changes in the

date or time on the server

Setting the date or time on the server that hosts any

module of the cobas

®

infinity POC tablet solution to the

future date and then back to the current date may lead to

unstable system behavior. Install a firewall, maintain up-

to-date antivirus software, and keep your operating

system up to date.

r Avoid changing the system time and date to the future

and then back to the current time and date.

Roche Diagnostics

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CAUTION

!

Incorrect or corrupt data due to unauthorized

access

Data security is breached if unauthorized users have

access to your ID 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 affiliate immediately.

CAUTION

!

Incorrect system operation after troubleshooting

activities, maintenance, or configuration changes

Any troubleshooting or maintenance activities or

configuration changes may result in the system operating

incorrectly.

r Verify that the modules of the cobas

®

infinity POC

tablet solution work as expected after performing

troubleshooting activities, database maintenance

tasks, or configuration changes.

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 cobas

®

infinity

POC tablet (mobile 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.

Roche Diagnostics

cobas® infinity POC tablet · Software version 1.0.0 · User Guide for Android · Version 1.0

12 Safety information

Data security

Failure to observe the safety information may result in

compromising the security of system data.

CAUTION

!

Unauthorized access and data loss due to malicious

software and hacker attacks

Portable storage media can be infected with and transmit

computer malware. This malware may be used to gain

unauthorized access to data or cause unwanted changes

to software.

r Ensure that all external devices are protected by

appropriate security software.

r Ensure that access to all external devices is protected

by appropriate security equipment.

r Do not copy or install any software on the Server. You

can do so only if it is part of the system software or a

Roche Service representative Instructs you to install it.

r If additional software is required, contact your Roche

Service representative to ensure validation of the

software in question.

r Do not use the USB ports to connect other storage

devices. You can only do so if official user

documentation or a Roche Service representative

instructs you to.

r Exercise utmost care when using external storage

devices such as USB flash drives, CDs, or DVDs. Do

not use them on public or home computers.

r Keep all external storage devices in a secure place

and ensure that only authorized persons can access

them.

r Recheck the external storage device between uses on

different systems in order to avoid cross-interference.

r Enable logging of suspicious events in the operating

system, e.g. failed logon attempts of administrator

users.

r Limit adding, moving, and deleting files or users to the

data that is mentioned in the documentation specific

to the modules of the cobas

®

infinity POC tablet

solution.

r Secure attached networks.

r Use state-of-the-art security mechanisms (e.g. WPA2

EAP) to protect WiFi connections.

r Make sure other computers and services on the

network (for example: the LIS, archiving share or -

service, 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

Roche Diagnostics

cobas® infinity POC tablet · Software version 1.0.0 · User Guide for Android · Version 1.0

13

equipment etc.).

r Make sure that system backups and archive files are

protected from any unauthorized access and disaster,

which includes: remote storage location; disaster

recovery sites; secure transfer of backup files.

r Roche recommends the following precautions:

o Allow connection to authorized external devices

only.

o Allow only internet access to trusted web sites and

web services.

o Enable Data Execution Prevention for all

applications (Windows Server).

o Monitor the system for suspicious activity and

report suspected compromise.

o Install the Windows security patch related to

MS14-066: Vulnerability in SChannel could allow

remote code execution.

o Allow only defined users to read and write

encryption keys (IIS App config / Windows Server

Hardening)

CAUTION

!

The product itself is 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 modules of the cobas

®

infinity POC tablet

solution do not come with their own virus scanner.

Therefore, Roche recommends protecting

corresponding computers and mobile devices against

harmful software using a virus scanner. If problems

occur, contact Roche.

CAUTION

!

Data loss

It is recommended that you prevent the app from

accidental data loss.

r Back up your data at regular intervals (ideally every

day).

Roche Diagnostics

cobas® infinity POC tablet · Software version 1.0.0 · User Guide for Android · Version 1.0

14 Safety information

CAUTION

!

Information revealed due to exposed network

services

Exposed network services may reveal unnecessary

information, such as the software version or information

about the vendor.

r Make sure to use secure channels to download

software updates of the system.

CAUTION

!

Cryptographic protocol

The https protocol is used for a secure communication

between the tablet app and 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.

Open source and third-party software

Portions of cobas

®

infinity POC tablet might include one

or more open source or commercial software programs.

For copyright and other notices and licensing information

regarding such software included with cobas

®

infinity

POC tablet, refer to the Software licenses document

available in the mobile app.

CAUTION

!

Malfunctions and incorrect results due to third-

party software

The installation of any third-party software that Roche

Diagnostics has not approved may lead to malfunctions.

r Do not install any unapproved software.

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CAUTION

!

Unable to establish a connection due to antivirus

software

cobas

®

infinity POC adapter has been tested using

antivirus software. It is important that the antivirus does

not prevent the adapter or Windows services for Internet

Information Services from establishing the connections to

ports specified in this document or to create files in the

configured folders.

r Configure the Windows firewall or the hardware

firewall based on the information provided by this

document or the Service Manual document.

Roche Diagnostics

cobas® infinity POC tablet · Software version 1.0.0 · User Guide for Android · Version 1.0

16 Setting up the app

Setting up the app

Configure the app to start working with it.

In this section

List of software and hardware requirements (16)

Installing the app (17)

Configuring the server address (18)

Configuring the app settings (19)

List of software and hardware requirements

Check what system version and devices are

recommended for cobas

®

infinity POC tablet.

Software requirements The app requires Android version 4.2 and higher.

Hardware requirements The following devices have been tested with the app:

• Samsung Galaxy Tab 4

• Samsung Galaxy Tab S

• Sony Xperia Z4 Tablet

• HP ProSlate 12

• Nexus 9

• HTC Nexus

For detailed information, refer to the Compatibility matrix

document.

Network connection

cobas

®

infinity POC tablet uses a network to connect to

cobas

®

infinity POC adapter and synchronize data. For

cobas

®

infinity POC tablet to work, both your tablet and

cobas

®

infinity POC adapter must be connected to the

internal network used at the hospital. If you are using the

app remotely, your device must be connected to the

internal network using a VPN connection.

u Related topics

• Installing the app (17)

• Getting started (27)

Roche Diagnostics

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17

Installing the app

You can run the app on a tablet with the Android system

installed.

n 5 minutes

j m Android 4.2 or higher

m Internet connection

r To install the app

1

Access the Play Store application.

2

Search for cobas

®

infinity POC tablet.

3

From search results, choose the app published by

F.Hoffman-La Roche.

4

Choose the Install button.

5

When the installation finishes, choose the Open

button to run it.

u Related topics

• List of software and hardware requirements (16)

• Configuring the server address (18)

• Getting started (27)

Configuring the server address

Before you log on, you must specify the server address to

be used.

If you are logging on for the first time, the app displays a

pop-up window where you can enter the server address.

You must configure it to run the app. You can then

modify the address, whenever necessary.

Roche Diagnostics

cobas® infinity POC tablet · Software version 1.0.0 · User Guide for Android · Version 1.0

18 Setting up the app

r To configure the server address

1

On the Logon screen, choose the button.

2

Enter the server address.

3

Choose the CONFIRM button.

u Related topics

• Logging on (30)

• Configuring the app settings (19)

Configuring the app settings

You can change the device, auto log off, and Google

analytics settings.

In this section

About device settings (20)

Changing the device settings (21)

Changing auto log off settings (24)

Changing Google analytics settings (25)

1

2

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19

About device settings

The app shows the connection and QC statuses of a

device based on the time limit you configured for each of

them.

You can set the time limit for connection and QC statuses

of a device. These settings are saved per user. This means

that once you configure them, they remain the same

regardless of the device on which you log in.

For connection status, you can set the threshold for when

the connection status of a device is displayed as an error.

For example, if the connection status timespan is set to 21

hours and the device connected with the cobas IT 1000

application 22 hours ago, the connection status is

displayed as an error.

For QC status, you can set the timespan that describes

how old QC results are evaluated. For example, if a QC

was performed 9 hours ago and was out of range, and the

QC status timespan is set to 22 hours, this QC status of a

device is displayed in red as an error. However, if a QC

timespan is set to 8 hours, it is displayed as a warning

because the QC status was performed outside of the

observed range.

u Related topics

• Changing the device settings (21)

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cobas® infinity POC tablet · Software version 1.0.0 · User Guide for Android · Version 1.0

20 Setting up the app

Changing the device settings

You can change the connection status and QC status

time range for devices.

r To change device settings

1

From the main menu, choose the button.

2

Choose the Devices option.

3

Select the device whose settings you want to change.

4

Choose the Successful connection required within

option.

1

2

3

4

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Roche cobas infinity POC Add-on User manual

Roche cobas infinity POC Add-on User manual

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