Roche cobas infinity POC Add-on User manual

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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.
Copyright ©2016 F. Hoffmann-La Roche Ltd. All rights 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.
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 tablet · Software version 1.0.0 · User Guide for Android · Version 1.0
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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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cobas® infinity POC tablet · Software version 1.0.0 · User Guide for Android · Version 1.0
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Managing QC results . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
About QC results . . . . . . . . . . . . . . . . . . . . . . . . . . . 72
Reviewing results . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
Rejecting results . . . . . . . . . . . . . . . . . . . . . . . . . 79
Accepting results . . . . . . . . . . . . . . . . . . . . . . . . 80
Roche Diagnostics
cobas® infinity POC tablet · Software version 1.0.0 · User Guide for Android · Version 1.0
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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
8 Preface
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
cobas® infinity POC tablet · Software version 1.0.0 · User Guide for Android · Version 1.0
9
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
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
cobas® infinity POC tablet · Software version 1.0.0 · User Guide for Android · Version 1.0
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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.
Roche Diagnostics
cobas® infinity POC tablet · Software version 1.0.0 · User Guide for Android · Version 1.0
15
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
cobas® infinity POC tablet · Software version 1.0.0 · User Guide for Android · Version 1.0
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)
Roche Diagnostics
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
/