Roche cobas IT 1000 User guide

Type
User guide

Roche cobas IT 1000 is a professional Point of Care data management software system that helps manage testing, collect results, and evaluate data based on user-specified criteria. It automatically receives data from POC devices and makes it available to professional personnel for review via a thin client and hospital network. Personnel can review data from multiple devices, audit quality controls, detect duplicate analyses, and more.

Roche cobas IT 1000 is a professional Point of Care data management software system that helps manage testing, collect results, and evaluate data based on user-specified criteria. It automatically receives data from POC devices and makes it available to professional personnel for review via a thin client and hospital network. Personnel can review data from multiple devices, audit quality controls, detect duplicate analyses, and more.

cobas IT 1000 application
Result and order matcher
User Guide
Version 1.0
Software version 2.10
Roche Diagnostics
cobas IT 1000 application · Software version 2.10 · Result and order matcher · User Guide · Version 1.0
2
Publication information
Edition notice This manual is for users of the cobas IT 1000 application.
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.
Software updates are done by Roche Service
representatives.
Where to find information The User Assistance contains all information about the
product, including the following:
Routine operation
Safety
Background information
!
General attention
To avoid incorrect results, ensure that you are familiar
with the instructions and safety information.
r Pay particular attention to all safety notices.
r Always follow the instructions in this publication.
r Do not use the software in a way that is not described
in this publication.
r Store all publications in a safe and easily retrievable
place.
Training Do not carry out operation tasks or maintenance actions
unless you have received training from Roche
Diagnostics. Leave tasks that are not described in the
user documentation to trained Roche Service
representatives.
Images The screenshots and hardware images in this publication
have been added exclusively for illustration purposes.
Configurable and variable data in screenshots, such as
tests, results, or path names visible therein must not be
used for laboratory purposes.
Warranty Any customer modification to the system renders the
warranty or service agreement null and void.
Publication version Software version Revision date Change description
1.0 2.10 May 2018 First version
y Revision history
Roche Diagnostics
cobas IT 1000 application · Software version 2.10 · Result and order matcher · User Guide · Version 1.0
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For conditions of warranty, contact your local sales
representative or refer to your warranty contract partner.
Always leave software updates to a Roche Service
representative, or perform such updates with their
assistance.
Copyright © 2005-2018, F. Hoffmann-La Roche Ltd. All rights
reserved.
License information The cobas IT 1000 application software is protected by
contract law, copyright law, and international treaties. The
cobas IT 1000 application 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 IT 1000 application may include components or
modules of commercial or open-source software. For
copyright and other notices and licensing information
regarding such software programs please see the
electronic distribution included with this product.
The cobas IT 1000 application as a whole may form a
device regulated in accordance with applicable laws. For
more detailed information, refer to the user manual and
labeling for details.
Please note that the respective authorization in
accordance with the applicable laws lapse in case of any
unauthorized changes to the cobas IT 1000 application.
Trademarks The following trademarks are acknowledged:
ROCHE, ROCHE OMNI, ACCU-CHEK, ACCU-CHEK
INFORM, ROCHE CARDIAC, COBAS B, COBAS,
COAGUCHEK and LIFE NEEDS ANSWERS are
trademarks of Roche.
Roche and the Roche symbol are registered
trademarks of the Roche group.
All other trademarks are trademarks of their owners.
Feedback Every effort has been made to ensure that this guide
fulfills its intended use. All feedback on any aspect of this
guide is welcome and will be considered during updates.
Please contact your Roche representative, should you
have any such feedback.
Roche Diagnostics
cobas IT 1000 application · Software version 2.10 · Result and order matcher · User Guide · Version 1.0
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Disclaimer This manual and the cobas IT 1000 application may
contain information and references to products that may
not be available in your country or sold by Roche
Diagnostics. This manual makes no claims regarding the
use or performance of those products. Selected 3rd party
products are available for use with the cobas IT 1000
application.
The complete list of Roche Diagnostics and 3rd party
products available for use with the cobas IT 1000
application in the US can be found at
http://usdiagnostics.roche.com/cobasITdevices
Other Roche Diagnostics or 3rd 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 IT 1000 application in the
US.
Contact addresses
Roche Diagnostics GmbH
Sandhofer Strasse 116
68305 Mannheim
Germany
Made in Switzerland
Distributed in the United States by:
Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46256
USA
Table of contents 1
Roche Diagnostics
cobas IT 1000 application · Software version 2.10 · Result and order matcher · User Guide · Version 1.0
Table of content
Publication information 2
Contact addresses 4
Table of content 1
Intended use 3
Features and Functionalities 4
Intended users 4
User roles, profiles, and access rights 5
Conventions used in this manual 6
This document 7
Safety instructions 8
Operation
3 Overview
About the Result and order matcher 13
Supported browsers 15
Overview of the main page 16
4 User actions
Logging on 19
Logging off 20
Using the User Assistance 21
Changing the language 22
Matching results to orders 23
Matching scenarios 25
Sending results without matching order 26
Discarding results 27
Appendix
Index 31
2 Table of contents
Roche Diagnostics
cobas IT 1000 application · Software version 2.10 · Result and order matcher · User Guide · Version 1.0
Roche Diagnostics
cobas IT 1000 application · Software version 2.10 · Result and order matcher · User Guide · Version 1.0
3
Intended use
The cobas IT 1000 application is a data management
software system for managing professional Point of Care
testing. It collects test results and associated data and
evaluates the data based on user-configurable criteria.
The system automatically receives data from POC devices
and delivers this data to a server application that can be
accessed via a thin client via the hospital’s network for
review by professional personnel.
The professional personnel can review data coming from
multiple devices, auditing that appropriate quality
controls have been run, detect duplicate analyses and
perform other data management functions.
u For more information about cobas IT 1000
application, refer to the cobas IT 1000 application
User Manual.
Not in scope of intended use This product is not intended for the diagnosis, screening,
monitoring or treatment of patients.
Roche Diagnostics
cobas IT 1000 application · Software version 2.10 · Result and order matcher · User Guide · Version 1.0
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Features and Functionalities
The main functions are:
Receiving electronically: patient test results, quality
control results, instrument messages and instrument
maintenance events
Receiving manually: quality control results and
comments
Storing patient test results, quality control results,
instrument messages and instrument maintenance
events
Managing users & certifications
Sending patient test results and quality control results
to customer IT systems (HIS&LIS)
Assessment of patient and quality control results to
support compliance with the customer’s quality
environment
Configuring the workflow of connected instruments
(for example configuring the patient identification
method on the instrument)
Reporting
Dashboard support: Live view (Production statistics)
Statistics generated by cobas IT 1000 application can
be extracted and displayed on monitors, wallboards
and mobile devices (accessible only within the
intranet).
Reception and storage of patient test orders;
automated and manual matching of patient test
results with corresponding test orders to provide
solicited test results.
Before using the system, it is important to read this
manual thoroughly.
Intended users
User group Description of use
Nurses/Nurse Educator Manual entry of quality control results
Entry of test material data (lot no., expiry date)
Retrospective assessment of results to support compliance with the customer’s quality
environment
Matching of patient test results with corresponding test orders
(1)
y Users
Roche Diagnostics
cobas IT 1000 application · Software version 2.10 · Result and order matcher · User Guide · Version 1.0
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User roles, profiles, and access rights
User access rights to the application are governed by
means of user profiles.
User access rights to instrument types are governed by
means of certification.
POC Coordinator Retrospective assessment of results to support compliance with the customer’s quality
environment
Entry of test material data (lot no., expiry date)
Adaptation of the configuration of cobas IT 1000 application
Configuration of connected instruments
View information generated by cobas IT 1000 application on Live View Dashboard.
IT Manager WLAN device configuration security type EAP
EAP Settings management (EAP settings and EAP settings assignment).
WLAN device configuration security type EAP
(1) user definitions may vary or be country specific: in US market ‘order matching’ is done by respiratory therapists
User group Description of use
y Users
User role Description of use
User Person who physically interacts with the software and/or the instrument.
A user is assigned to one or several locations.
User profile: Operator The user profile “Operator” is used for individuals who do not have access to the
application but who physically interact with the instrument.
An operator is assigned to one or several locations.
An operator is required to be certified for each of the instrument types used.
y User roles
Roche Diagnostics
cobas IT 1000 application · Software version 2.10 · Result and order matcher · User Guide · Version 1.0
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Conventions used in this manual
Within step by step procedures, we have included screen
captures from the application to provide you with
graphical representations of where and how to perform
tasks.
The following symbols and conventions are used in this
manual.
Symbols The following symbols may be used to draw your
attention to important information:
Product names The following product names and abbreviations are used.
Symbols used on product
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.
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.
y Symbols used in the publication
Product name Explanation
cobas IT 1000 application
application
system
y Product names
Symbol Explanation
Global Trade Item Number
y Symbols used on product
Roche Diagnostics
cobas IT 1000 application · Software version 2.10 · Result and order matcher · User Guide · Version 1.0
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q
o Keep this manual in a place where it will not be
damaged.
o Ensure that this document is available at all times.
This document
This document serves 3 purposes:
It provides descriptions of the Result and order
matcher user interface elements.
It provides step by step procedures to perform routine
tasks.
It provides information regarding various aspects of
the Result and order matcher.
The document consists of one main part and an appendix.
u Operation (9)
An overview of the Result and order matcher, a
description of the user interface, and instructions how
to perform routine tasks
u Appendix (29)
An index of various topics
To help you find the information you are looking for, there
is a table of contents at the beginning of each chapter, as
well as at the beginning of the manual.
This same document is used to produce the User
Assistance, in addition to the printable User Guide.
Roche Diagnostics
cobas IT 1000 application · Software version 2.10 · Result and order matcher · User Guide · Version 1.0
8 Safety instructions
Safety instructions
Safety classification The safety precautions and important user notes are
classified according to the ANSI. Familiarize yourself with
the following meanings and icons:
!
Safety alert symbol
r The safety alert symbol is used to alert you to potential
physical injury hazards. To avoid possible injury or
death, comply with all safety messages that follow this
symbol.
These symbols and signal words are used for specific
hazards:
WARNING
!
Warning…
r …indicates a hazardous situation that, if not avoided,
could result in death or serious injury.
CAUTION
!
Caution…
r …indicates a hazardous situation that, if not avoided,
could result in minor or moderate injury.
NOTICE
Notice…
r …indicates a hazardous situation that, if not avoided,
may result in damage to the analyzer.
Roche Diagnostics
cobas IT 1000 application · Software version 2.10 · Result and order matcher · User Guide · Version 1.0
Operation
3 Overview .................................................................................................................... 11
4 User actions.............................................................................................................. 17
3 Overview
Roche Diagnostics
cobas IT 1000 application · Software version 2.10 · Result and order matcher · User Guide · Version 1.0
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Table of contents
Overview 3
In this chapter
3
About the Result and order matcher . . . . . . . . . . . . . . 13
Supported browsers . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Overview of the main page . . . . . . . . . . . . . . . . . . . . . . 16
3 Overview
Roche Diagnostics
cobas IT 1000 application · Software version 2.10 · Result and order matcher · User Guide · Version 1.0
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Table of contents
3 Overview
Roche Diagnostics
cobas IT 1000 application · Software version 2.10 · Result and order matcher · User Guide · Version 1.0
Overview 13
About the Result and order matcher
The Result and order matcher application is designed
for respiratory therapists and other caregivers performing
blood gas analysis to manage test results for which the
cobas IT 1000 application could not find a matching
order.
It provides the following functionalities:
Matching results to orders For each unmatched result, a list of matchable orders is
provided. You can select an order and match it to the
result. The matched result is then sent to the LIS as long
as it is validated and accepted in the cobas IT 1000
application.
u Matching results to orders (23)
Sending results without matching order You can send a result to the LIS without a matching order
(unsolicited sending). As soon as the result is validated
and accepted in the cobas IT 1000 application, it is
automatically sent to the LIS.
u Sending results without matching order (26)
Discarding results You can discard results. Discarded results are removed
from the Result and order matcher and not sent to the
LIS. Discarded results are still retained in the cobas IT
1000 application.
u Discarding results (27)
Limited access to results The user can view the following results in the Result and
order matcher:
Results from instruments assigned to a location (at the
time of result reception) that is also assigned to the
user.
Results from instruments without an assigned location
at the time of result reception.
f Ensure that the user has the correct locations assigned
in the cobas IT 1000 application.
q If a user has no locations assigned, all results are
displayed without any restrictions regarding assigned
instrument locations.
3 Overview
Roche Diagnostics
cobas IT 1000 application · Software version 2.10 · Result and order matcher · User Guide · Version 1.0
14 About the Result and order matcher
CAUTION
!
Incorrect patient assignment
The patient visit of a sample may be changed in the
cobas IT 1000 application before the sample is sent to
the LIS. The visit may be changed to a different visit of the
same patient, or a visit of a different patient. Any action
performed on that sample in the Result and order
matcher before the visit change is undone.
The sample may reappear in the Result and order
matcher to be matched or sent as unsolicited again,
which can delay the sending of results to the LIS.
r Ensure to check the Result and order matcher
regularly.
3 Overview
Roche Diagnostics
cobas IT 1000 application · Software version 2.10 · Result and order matcher · User Guide · Version 1.0
Overview 15
Supported browsers
The Result and order matcher supports the following
browsers.
Desktop version: Internet Explorer 11
Tablet version (Android): Chrome
Tablet version (iOS): Safari
q You must configure the browser to enable the use of
cookies.
3 Overview
Roche Diagnostics
cobas IT 1000 application · Software version 2.10 · Result and order matcher · User Guide · Version 1.0
16 Overview of the main page
Overview of the main page
A Free-text search field
B Action buttons
C Info button - access to User Assistance and software information
D User button - log off from the Result and order matcher
A
B
CD
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Roche cobas IT 1000 User guide

Type
User guide

Roche cobas IT 1000 is a professional Point of Care data management software system that helps manage testing, collect results, and evaluate data based on user-specified criteria. It automatically receives data from POC devices and makes it available to professional personnel for review via a thin client and hospital network. Personnel can review data from multiple devices, audit quality controls, detect duplicate analyses, and more.

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