Roche cobas infinity POC Add-on User manual

Roche
Brand
Roche
Model
cobas infinity POC Add-on
Type
User manual

Roche cobas infinity POC Add-on is a mobile app that allows professional personnel to manage Point of Care testing remotely using mobile devices. It connects with cobas IT 1000 to collect POC results and associated data, providing an overview of system, device, operator, and certification status. The app enables users to complete tasks away from their desk, reducing the time required for tasks such as adding and editing operators, updating training criteria, exporting lists of operators needing training, and viewing available certifications.

Roche cobas infinity POC Add-on is a mobile app that allows professional personnel to manage Point of Care testing remotely using mobile devices. It connects with cobas IT 1000 to collect POC results and associated data, providing an overview of system, device, operator, and certification status. The app enables users to complete tasks away from their desk, reducing the time required for tasks such as adding and editing operators, updating training criteria, exporting lists of operators needing training, and viewing available certifications.

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cobas
®
infinity POC mobile
App for Android and iOS devices
User Guide and Installation Instructions 1.2
Software Version 1.1.0
cobas
®
infinity POC mobile
Roche Diagnostics
1
User Guide – 1.2
Editor’s note
This manual is for users of the cobas® infinity POC mobile application. Every effort has been made to ensure
that the information contained in this manual is accurate at the time of release.
Not all functionality described in this manual may be available to all users. Roche reserves the right to make
any further required changes to software without prior notice. Such changes may not be immediately reflected
in this document.
Definitions
The following abbreviations are used in this document:
Abbreviation Description
POC Point of Care
POCC Point of Care Coordinator
POCT Point of Care Testing
VPN Virtual Private Network
iOS Operating system for Apple mobile devices
Intended use
The 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 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 Mobile 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, 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.
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®
infinity POC mobile
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User Guide – 1.2
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Screen captures
The screen captures in this publication have been added exclusively for the purpose of illustration.
Configurable and variable data such as patient demographics, parameters, results, path names, etc. visible
therein are fictitious and must not be used for laboratory purposes.
Copyright and trademarks
Copyright © 2007-2016 F. Hoffmann-La Roche Ltd. All rights reserved.
Trademarks Recognized trademarks:
• ROCHE and COBAS are trademarks of Roche.
• Roche and the Roche symbol are registered trademarks of the Roche group.
• All other trademarks are trademarks of their owners.
Open source and third party software
Portions of cobas® infinity POC mobile might include one or more open source or commercial software
programs. For copyright and other notices and licensing information regarding such software programs
included with cobas® infinity POC mobile, refer to the Software licenses document available in the mobile
application. To access the document, tap the More icon ( ), select Help and then tap Software license.
Access control
Only users with the following profiles can access the application:
• POCT Admin
• POCC
• Nurse Educator
• IT Manager
• Service
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®
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User Guide – 1.2
Revision history
Document version Software version Date Change description
1.0 1.0 April 2015 Document created
1.1 1.1.0 December 2015
Software and document
updates
1.2
1.1.0
July 2016
Minor document updates
Contact address
Manufacturer
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Switzerland
US Distribution
Roche Diagnostics
9115 Hague Road
PO Box 50457
Indianapolis, IN 46250-0457
USA
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®
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User Guide – 1.2
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What is new in this version
The possibility to add an operator and edit an existing operator was added.
The possibility to update the operator’s training criteria was added.
Exporting the list of operators who need training to a file was added.
The possibility to view all available certifications was added.
Entering the reason for change is now necessary.
check:
When you access the application, it checks the compatibility of the interface and adapter
version.
control:
Users with the following profiles can access the application:
• POCT Admin
• POCC
• Nurse Educator
• IT Manager
• Service
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®
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User Guide – 1.2
Table of Contents
Editor’s note.................................................................................................................................................................. 1
Definitions .................................................................................................................................................................... 1
Intended use ................................................................................................................................................................. 1
Screen captures............................................................................................................................................................. 2
Copyright and trademarks.......................................................................................................................................... 2
Open source and third party software ...................................................................................................................... 2
Access control............................................................................................................................................................... 2
Revision history............................................................................................................................................................ 3
Contact address ............................................................................................................................................................ 3
What is new in this version ........................................................................................................................................ 4
Software overview ............................................................................................................................................................ 7
Introduction ................................................................................................................................................................. 7
Safety information ....................................................................................................................................................... 8
Safety classifications ................................................................................................................................................ 8
System safety ............................................................................................................................................................ 8
Data security........................................................................................................................................................... 10
Open source and third-party software................................................................................................................ 12
System requirements ................................................................................................................................................. 13
Recommended devices .............................................................................................................................................. 13
Network connection .................................................................................................................................................. 13
Installing the application ............................................................................................................................................... 14
Installing cobas
®
infinity POC mobile on Android devices .................................................................................. 14
Installing cobas
®
infinity POC mobile on iOS devices .......................................................................................... 14
Configuring the server address ................................................................................................................................ 14
Getting started ................................................................................................................................................................ 15
Touch gestures ........................................................................................................................................................... 15
Navigating cobas
®
infinity POC mobile on iOS ..................................................................................................... 16
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®
infinity POC mobile
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Navigating cobas
®
infinity POC mobile on Android ............................................................................................. 17
User accounts and passwords................................................................................................................................... 18
Logging in ................................................................................................................................................................... 19
Logging out ................................................................................................................................................................. 19
Changing password ................................................................................................................................................... 19
About auto logout and device settings .................................................................................................................... 20
Changing auto logout settings ............................................................................................................................. 20
Changing device settings ...................................................................................................................................... 20
Getting help ................................................................................................................................................................ 21
Managing devices ........................................................................................................................................................... 22
About devices ............................................................................................................................................................. 22
Viewing device status per site .................................................................................................................................. 24
Viewing device details ............................................................................................................................................... 24
Editing devices ........................................................................................................................................................... 24
Replacing devices ....................................................................................................................................................... 25
Managing operators ....................................................................................................................................................... 27
About operators ......................................................................................................................................................... 27
Viewing operator details ........................................................................................................................................... 28
Adding an operator ................................................................................................................................................... 29
Examples ................................................................................................................................................................. 29
Updating operator’s details ...................................................................................................................................... 30
Updating operator’s training status......................................................................................................................... 31
Exporting a list of operators who need training .................................................................................................... 31
Managing certifications ................................................................................................................................................. 33
About certifications ................................................................................................................................................... 33
Viewing certification details ..................................................................................................................................... 34
Updating training status for certificate criteria ..................................................................................................... 34
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®
infinity POC mobile
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User Guide – 1.2
Software overview
Refer to this section for system requirements, application and device security guidelines, and installation
instructions.
Introduction
cobas® infinity POC mobile is an application developed with Point of Care (POC) Device Coordinators and
Nurse Educators in mind. cobas® infinity POC mobile connects via the cobas® infinity POC mobile adapter
to the cobas IT 1000 application to download and display all the device and user data.
The application is available for Android and iOS devices.
For POC Coordinators
The application helps in managing Point of Care (POC) devices by allowing coordinators to:
• Check device status.
• Quickly replace malfunctioning devices.
• Edit device details, such as name, location, and configuration.
For Nurse Educators
The application makes it possible to view all POC device operators and their training and certification
statuses. With cobas® infinity POC mobile, an educator can check the necessary certifications to find out
what training courses need to be organized.
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®
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User Guide – 1.2
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Safety information
Safety classifications
The following 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 will result in injury or death is not applicable to
this system and is therefore not listed.
Warning
Indicates a potentially dangerous situation which, if ignored, may lead to
fatal or severe injuries.
Caution
Indicates a potentially dangerous situation which, if ignored, may lead to
injuries and/or damage to property.
NOTICE
Indicates a message not related to personal injury.
System safety
Failure to observe the following safety information may result in incorrect results, data corruption, and data
loss.
False or corrupt data due to incorrect operation or use of wrong
modules
Incorrect operation or misuse of the system may lead to corrupt data.
• Use only computers, monitors, printers, and accessories recommended
by the manufacturer.
• 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.
• Reboot the Server(s) after a change of time zone.
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®
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User Guide – 1.2
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.
• Install a firewall, maintain up to date antivirus software and keep your
operating system up to date.
• Configure the firewall to allow instruments and information systems to
connect with the modules of the cobas® infinity POC mobile solution.
Unstable system behavior due to changes in the date or time on
the server
Setting the date or time on the server hosting any of the modules of the
cobas® infinity POC mobile 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.
• Avoid changing the server time or date to the future and then back to
the current time or date.
False or corrupt data due to unauthorized access
Data security is breached if unauthorized users have access to your user ID
and password.
• Always enter your password unobserved.
• Do not write down your password.
• Never write down the password in a contact form, in the address book
or in a file on the computer.
• Do not disclose your password to anyone.
• Roche will never ask you for your password.
• If you ever disclose your password to anyone, change it immediately
after.
• If you think anyone else has access to your account, then contact your
Roche affiliate.
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®
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User Guide – 1.2
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Incorrect system operation after troubleshooting activities,
maintenance or configuration changes.
Troubleshooting or maintenance activities or configuration changes may
result in the system operating incorrectly.
• Verify that the modules of the cobas® infinity POC mobile solution
work as expected after performing troubleshooting activities, database
maintenance tasks or configuration changes.
Data security
Unauthorized access and data loss due to malicious software and
hacker attacks
Computer malware can enable unauthorized access to the system or
unwanted software changes.
• Ensure that all external devices are protected by appropriate security
software.
• Ensure that access to all external devices is protected by appropriate
security equipment.
• Do not copy or install any software on the Server unless it is part of the
system software or you are instructed to do so by a Roche service
representative.
• If additional software is required, contact your Roche service
representative to ensure validation of the software in question.
• Enable logging of suspicious events in the operating system, e.g. failed
login attempts of administrator users.
• Limit adding, moving and deleting files or applications to the data that
is mentioned in the documentation specific to the modules of the cobas®
infinity POC mobile solution.
• Secure attached networks.
• Use state-of-the-art security mechanisms (e.g. WPA2 EAP) to protect
WiFi connections.
• 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.
• Restrict physical access to the system and all attached IT infrastructure
(computer, cables, network equipment etc.).
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®
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User Guide – 1.2
• Make sure that system backups and archive files are protected from any
unauthorized access and disaster, this includes: remote storage location;
disaster recovery sites; secure transfer of backup files.
• 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 applications to read and write encryption keys
(IIS App config / Windows Server Hardening).
• The modules of the cobas® infinity POC mobile 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, please contact Roche.
Additional protection 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 measures, such as a firewall, to separate the device
from uncontrolled networks as well as 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
• Ensure that the product protection against malicious software and
hacker attacks is sufficient.
• The modules of the cobas® infinity POC mobile 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, please contact Roche.
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®
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User Guide – 1.2
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External storage device security
Unsecured external storage devices can lead to unauthorized access and
data loss.
• Do not use the USB ports to connect other storage devices unless you
are instructed to do so by official user documentation or a Roche service
representative.
• 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 while connecting to the computer.
• Keep all external storage devices in a secure place and ensure that they
can be accessed by authorized persons only.
• Recheck the external storage device between uses on different systems in
order to avoid cross-interference.
Open source and third-party software
Portions of cobas® infinity POC mobile might include one or more open source or commercial software
programs. For copyright and other notices and licensing information regarding such software programs
included with cobas® infinity POC mobile, refer to the Software licenses document available in the mobile
application.
Malfunctions and incorrect results due to third-party software
The installation of any third-party software that has not been approved by
Roche Diagnostics may lead to malfunctions.
• Do not install any unapproved software.
Unable to establish a connection due to antivirus software
cobas® infinity POC adapter has been tested using antivirus software but it
is important that the antivirus does not prevent the adapter or the Windows
services for Internet Information Services from establishing the connections
to the ports specified in this document or to create files on the configured
folders.
• Configure the Windows firewall or the hardware firewall based on the
information provided by this document or the Service Manual
document.
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®
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User Guide – 1.2
System requirements
cobas® infinity POC mobile requires the following versions of Android and iOS:
System Supported version
Android
4.1 and higher
iOS 7.0 and higher
Recommended devices
System Device model
iOS
iPhone 6 Plus
iPhone 6
iPhone 5s
iPhone 4s
iPod
Android
Samsung S5
Samsung S4
Samsung S3
Sony Xperia Z3
Google Nexus 5
Network connection
cobas® infinity POC mobile uses a network to connect to cobas® infinity POC mobile adapter and
synchronize data. For cobas® infinity POC mobile to work, both your mobile device and cobas® infinity POC
mobile adapter must be connected to the internal network used at the hospital. If you are using cobas®
infinity POC mobile remotely, your device must be connected to the internal network using a VPN
connection.
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®
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Installing the application
cobas® infinity POC mobile is available for Android and iOS devices. The following sections of this user
manual provide instructions for installing the app on Android and iOS devices.
Installing cobas
®
infinity POC mobile on Android devices
To install cobas® infinity POC mobile:
1. On your device, access the Play Store application.
2. Search for cobas® infinity POC mobile.
3. Open the application (published by F.Hoffman-La Roche) from the search results.
4. Tap the Install button. The application installs.
5. When the installation finishes, tap Open to run it.
Installing cobas
®
infinity POC mobile on iOS devices
To install cobas® infinity POC mobile:
1. On your device, access the App Store.
2. Choose the Search option in the menu and search for cobas® infinity POC mobile.
3. Choose the application (published by F.Hoffman-La Roche) in search results.
4. Tap the Download and then the Install button. The application installs.
5. When the installation finishes, tap Open to run it.
Configuring the server address
Before you log in, you must specify the server address to be used. Contact your local administrator to obtain
the server address of your cobas IT 1000 application.
If you are logging in for the first time, the application displays a pop-up window where you can enter the
server address.
To change the server address:
1. Open the application.
2. On the Login screen, tap the Settings icon (Android: iOS: ).
3. Enter the server address and tap OK.
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®
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User Guide – 1.2
Getting started
This section provides instructions on how to customize the cobas® infinity POC mobile interface, where to
find help and what action gestures you can use.
Certain cobas® infinity POC mobile icons and functionalities are accessible from different locations on iOS
and Android. Refer to the sections below for more information.
Touch gestures
cobas® infinity POC mobile uses Android and iOS touch gestures for interacting with the application. Refer
to the table below for descriptions of gesture sets supported by Android and iOS.
Gesture name How to do it? What it does?
Tap Press the screen. Triggers the default functionality for a given item.
Press
Press the screen and
wait.
• Enters data selection mode.
•
Allows you to select one or more items in a view and act upon
the data using a contextual action bar.
Swipe
Press the screen and
move your finger.
Scrolls overflowing content, or navigates between views in the
same hierarchy.
On iOS only
Swiping from left to right moves you one step back in the
hierarchy.
Pull down
Press the screen and
swipe down.
Refreshes the view.
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®
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Navigating cobas
®
infinity POC mobile on iOS
1. Access the basic functionalities of the application from a toolbar located at the bottom of the screen:
2. Tap an icon to open a given functionality.
3. Use the More icon to access the application settings, to enable help overlays, or to log out.
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®
infinity POC mobile
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User Guide – 1.2
Navigating cobas
®
infinity POC mobile on Android
1. To access the application functionalities, tap the icon at the top of the screen.
It opens a menu with all the application functionalities:
2. Tap any menu item to switch to this functionality.
3. To access the application settings, enable help overlays, or log out, tap the dots icon at the top of the
screen:
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®
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User accounts and passwords
During the adapter installation a shared key is applied. This information is encrypted by the installer.
There are no entries in any configuration file regarding Usernames or Passwords.
Users and passwords are managed within cobas IT 1000.
Operators must choose strong passwords. The characteristics of strong passwords are as follows:
• Passwords must not contain the user's account name or parts of the
user's full name that exceed two consecutive characters.
• Passwords must be at least eight characters in length.
• Passwords must contain characters from at least three of the following
four categories:
o English uppercase alphabetic characters (A through Z)
o English lowercase alphabetic characters (a through z)
o Numeric characters (0 through 9)
o Non-alphabetic characters (for example, !, $, #, %)
• Operators are not allowed to share their user accounts.
Data loss
It is recommended that you prevent the application from accidental data
loss
• Back up your data at regular intervals (ideally every day).
Handling mobile devices
Mobile devices on which the application runs must be handled with care to
ensure the application security.
• 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).
• Do not root or jail break your mobile device.
• Android users: disable installation of application from untrusted
sources.
• For security reasons, connect the cobas® infinity POC mobile
Application (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.
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®
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User Guide – 1.2
Information revealed due to exposed network services
Exposed network services may reveal unnecessary information like the
software version or information about the vendor
• Make sure to use secure channels when downloading software updates
of the system.
Logging in
To log in:
1. On the Login screen, enter your user name and password.
2. Tap Log on.
What happens next
The application checks the version compatibility between the interface and the adapter. If the versions are
incompatible, you may be asked to update the application.
After the first login, the screen displays icons containing the first two characters of the user IDs for the most
recent three users who accessed cobas® infinity POC mobile.
In the preceding graphic, the icons stand for users Emma and Roche. Clicking an icon fills in the user name
field so that all the user needs to provide is the password. To remove a user icon, press and hold it; then move
it to the trash can that displays.
Logging out
You can log out from any location in the application. To log out:
1. Tap the dots icon (Android: iOS: ).
2. Tap Log off.
Changing password
Manage user profiles in the cobas IT 1000 application. To change your application password, contact your
POCC.
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Roche cobas infinity POC Add-on User manual

Roche
Brand
Roche
Model
cobas infinity POC Add-on
Type
User manual

Roche cobas infinity POC Add-on is a mobile app that allows professional personnel to manage Point of Care testing remotely using mobile devices. It connects with cobas IT 1000 to collect POC results and associated data, providing an overview of system, device, operator, and certification status. The app enables users to complete tasks away from their desk, reducing the time required for tasks such as adding and editing operators, updating training criteria, exporting lists of operators needing training, and viewing available certifications.

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