Roche cobas infinity POC User guide

cobas

®

infinity POC

User Guide

Publication version 2.2

Software version 2.0.1

2

Roche Diagnostics

cobas

®

infinity POC · Software version 2.0.1 · User Guide · Publication version 2.2

Publication information

Publication version Software version Revision date Change description

1.0 1.0 July 2018 First version

1.1 1.0.1 September 2018 Update of supported iOS versions

1.2 1.0.2 March 2019 Update of supported browser versions

Changeable table row size in QC result panel

Search filter for QC results

Improved view of blood gas devices

2.0 2.0 February 2020

Implementation of features and functionality from cobas IT

1000 application.

Change of product name

• Product name used in software version 2.0:

cobas

®

infinity POC

• Product name used in software versions 1.x:

cobas

®

infinity POC IT solutions

2.1 2.0.1 August 2020 Application still responsive if spinning circle stops.

Integrated access to the cobas

®

infinity edge application (if

configured and with corresponding access rights).

Numeric input in Internet Explorer.

Auto logoff after configurable session expiration time, i.e.,

period of inactivity.

"%" and "_" characters are wildcards for searching. Searching

by date requires the full date in the format configured in the

personal settings.

Separate chart for unassigned devices.

Assigning active and inactive devices to locations.

Display of locking status of devices.

Detection and display of unlicensed devices. No actions for

unlicensed devices.

Custom sorting of the blood gas overview.

Accessing the device messages and notes from the blood gas

overview.

Updated QC families screen: additional table columns,

updated search options, and extended filter criteria.

Exporting QC results.

Updated Proficiency results screen: display of alarms.

Updated Material lots screen: extended filter criteria.

Lot version displayed in the lot details for device types

supporting lot versions.

Information on default ranges.

User-specific and newly added application-wide settings in

Device management > Settings.

y Revision history

3

Roche Diagnostics

cobas

®

infinity POC · Software version 2.0.1 · User Guide · Publication version 2.2

Publication version Software version Revision date Change description

2.1 (continued) 2.01 August 2020 Configuring manual or automatic lot management.

Configuring absolute QC target deviations per QC lot version

for device types supporting lot versions..

Unfulfilled certification criteria for valid certification status.

Special characters +,/,_,-,$,\,@ in operator IDs.

Updated Result validation screen: additional table columns

and extended filter criteria.

Visit details displayed in the patient result details.

Changing the associated patient for several results from the

result list.

Resending results to the host.

Unvalidating results.

Exporting patient results.

Information on format of language, numbers, and dates in

reports.

Display of results in linearity reports.

Port 636 for secure connection to LDAP server.

Configuration options for unvalidating results and for session

expiration time.

RiliBÄK: Configure the start of the daily routine at least

5minutes before the time the QC tests are done on the

instruments.

Current name of demographic fields does not apply to other

screens.

Mulitsite concept updated.

Updated information for Menus screen.

Editing notification templates updated.

Importing EAP settings.

Field definitions for multirules.

u What is new in publication version 2.1 (11)

2.2 2.01 December 2020 Editorial changes to remove non-applicable references.

Glossary added.

u What is new in publication version 2.2 (11)

y Revision history

Edition notice

This publication is intended for users of the

cobas

®

infinity POC 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.

4

Roche Diagnostics

cobas

®

infinity POC · Software version 2.0.1 · User Guide · Publication version 2.2

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.

Software updates are done by Roche Service

representatives.

Training

Do not carry out operation tasks or maintenance actions

unless you have received training from Roche

Diagnostics. Leave tasks that are not described in the

user documentation to trained Roche Service

representatives.

Images

The screenshots in this publication have been added

exclusively for illustration purposes. Configurable and

variable data in screenshots, such as tests, results, or

path names visible therein must not be used for

laboratory purposes.

Warranty

Any customer modification to the system renders the

warranty or service agreement null and void.

For conditions of warranty, contact your local sales

representative or refer to your warranty contract partner.

Copyright

reserved.

License information

The cobas

®

infinity POC application is protected by

contract law, copyright law, and international treaties.

The cobas

®

infinity POC application contains a user

license between F. Hoffmann-La Roche Ltd. and a

license holder, and only authorized users may access the

application and use it. Unauthorized use and distribution

may result in civil and criminal penalties.

Open Source and Commercial Software

Portions of the cobas

®

infinity POC application might

include one or more Open Source or Commercial

Software programs. For copyright and other notices and

5

Roche Diagnostics

cobas

®

infinity POC · Software version 2.0.1 · User Guide · Publication version 2.2

licensing information regarding such Software programs

included with cobas

®

infinity POC please see the

Licenses folder in cobas

®

infinity POC installation.

Trademarks

The following trademarks are acknowledged:

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

COBAS, COBAS INFINITY, 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 fulfils the intended use. All feedback on any

aspect of this publication is welcome and is considered

during updates. Contact your Roche representative,

should you have any such feedback.

Languages

The application is displayed in the language defined for

each user ID in the cobas

®

infinity POC application.

Disclaimer

This publication may contain information and references

to products that may not be available in your country or

sold by Roche Diagnostics. This publication makes no

claims regarding the use or performance of those

products. Selected third-party products are available for

use with the cobas

®

infinity POC application.

The complete list of Roche Diagnostics and third-party

products available for use with the cobas

®

infinity POC

application in the US can be found at http://

usdiagnostics.roche.com.

Other Roche Diagnostics or third-party products listed

within the software or manuals which are not listed at

http://usdiagnostics.roche.com are not available for use

with the cobas

®

infinity POC application in the US.

Cybersecurity

It is important to note that cobas

®

infinity POC is not

intended to be used for patient diagnosis or treatment

decisions. Such decisions should be made on the basis

of the results displayed on the POC instrument. Users of

the cobas

®

infinity POC system should pay particular

attention to cybersecurity. In particular, ensure that an

attacker is not able to modify results in

6

Roche Diagnostics

cobas

®

infinity POC · Software version 2.0.1 · User Guide · Publication version 2.2

cobas

®

infinity POC nor on the way to any downstream

systems that are being used in patient diagnosis or

treatment decisions (e.g. a LIS or EHR).

Contact addresses

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Switzerland

Distributed in USA by:

Roche Diagnostics

9115 Hague Road

Indianapolis, Indiana

USA

7Table of contents

Roche Diagnostics

cobas

®

infinity POC · Software version 2.0.1 · User Guide · Publication version 2.2

Table of contents

Publication information 2

Contact addresses 6

Intended use 9

Symbols and abbreviations 9

What is new in publication version 2.2 11

What is new in publication version 2.1 11

Safety

1 Safety information

Safety classifications 21

System safety 22

Safety information for IT managers 24

Laboratory workflows 28

Privacy protection 29

Operation

2 Overview of the application

Logging on to the application 35

Logging off from the application 39

Configuring personal settings 40

Changing your password 41

Searching and filtering 42

About the User Assistance 44

Specifications 49

About the intended users 52

3 Device Management

Devices 55

Quality Control 69

Materials 86

Settings 95

4 Operator management

Operators 101

Certifications 107

5 Patient results

Result validation 115

Patient history 126

6 Reports

QC reports 131

Other reports 136

7 Result and order matcher module

Overview 145

User actions 148

Configuration

8 System

General settings 163

Instrument Alarm Assignment 203

System Alarm Assignment 205

Instrument Alarm Definition 206

Test Definition 216

Test Group Definition 221

Tube Definition 227

Sample Type Definition 229

Comment Definition 231

Message broker monitor 233

Orderable panels 235

Demographic Definition 239

Material definition 241

9 Organization

Organization module components 247

Sites 248

Locations 254

HIS Locations 259

User Profiles 261

Certificates 268

Automated user import log 282

User Import 283

HIS Location Import 292

Notification Templates 294

LMS Import Errors 299

Workgroup Definition 301

10 Devices

Configuration 305

Offline devices 315

EAP settings 317

EAP settings import 324

EAP settings assignment 327

Comment Assignment 330

11 Quality Control

QC Test Mapping 335

Multirules 339

12 Quality Control (RiliBÄK)

RiliBAeK Test Assignment 345

QC Test Mapping (RB) 350

Glossary

Index

8

Roche Diagnostics

cobas

®

infinity POC · Software version 2.0.1 · User Guide · Publication version 2.2

9

Roche Diagnostics

cobas

®

infinity POC · Software version 2.0.1 · User Guide · Publication version 2.2

Intended use

cobas

®

infinity POC is a data management software

system providing governance and connectivity to Point of

Care devices centralizing the management of

professional Point of Care testing service.

cobas

®

infinity POC supports workflow configuration of

connected Point of Care devices, management of device

related data, operators, test orders and patient

demographic data including results.

These data are automatically received, stored and

evaluated based on user-configurable criteria and sent to

the customers Health Information Systems.

The professional personnel can review and audit these

data and perform other data management functions.

This product is not intended for the diagnosis, screening,

monitoring or treatment of patients.

It is important to note that cobas

®

infinity POC is not

intended to be used for patient diagnosis or treatment

decisions. Such decisions should be made on the basis of

the results displayed on the POC instrument.

Symbols and abbreviations

Product names

Except where the context clearly indicated otherwise, the

following product names and descriptors are used.

Product name Descriptor

cobas

®

infinity POC

application

y Product names

Symbols used in the publication

Symbol Explanation

o

List item.

u

Related topics containing further information.

y Symbols used in the publication

10

Roche Diagnostics

cobas

®

infinity POC · Software version 2.0.1 · User Guide · Publication version 2.2

Symbol Explanation

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

Symbols used on the product

Symbol Explanation

Catalogue number

Global Trade Item Number

Date of manufacture

Manufacturer

y Symbols used on the product

11

Roche Diagnostics

cobas

®

infinity POC · Software version 2.0.1 · User Guide · Publication version 2.2

Symbol Explanation

Consult instructions for use

Caution

y Symbols used on the product

Abbreviations

The following abbreviations are used.

Abbreviation Definition

ANSI American National Standards

Institute

EHR Electronic Health Record

LIS Laboratory Information System

POC Point of Care

POCC Point of Care coordinator

POCT Point of Care testing

VPN Virtual Private Network

y Abbreviations

What is new in publication version 2.2

Product names

Editorial changes to remove non-applicable references.

Glossary

Glossary added.

What is new in publication version 2.1

Responsive application

The application is still responsive even if the circle on the

screen stops spinning.

cobas

®

infinity edge

You can access the cobas

®

infinity edge application

from the cobas

®

infinity POC application.

The URL of the cobas

®

infinity edge application must be

configured in Configuration > System > General

settings > Edge.

12

Roche Diagnostics

cobas

®

infinity POC · Software version 2.0.1 · User Guide · Publication version 2.2

To access the cobas

®

infinity edge application, you

must have the corresponding access rights.

u Logging on to the application (35)

u Edge (164)

Numeric input when using Internet Explorer

When you access the application with Internet Explorer,

you must use the alphanumeric keyboard to enter the

minus symbol "-" or the decimal dot "."in fields that

require numeric input.

u List of technical requirements (49)

Auto logoff

If you are inactive, you are automatically logged off from

the application after a time period that is configured in

the general settings (default value = 90 minutes).

If the value is set to 0, the auto logoff is disabled.

u Logging off from the application (39)

u Session Expiration Time (Minutes) (198)

Searching and filtering

The "%" (percent sign) character and the

"_" (underscore) character are the search and filter

wildcards. If you enter only these characters, all records

are found.

To search by date, you must enter the full date in the

date format configured in the personal settings, e.g.,

MM/dd/yyyy.

u Searching and filtering (42)

Device management > Devices

A separate chart for unassigned devices is displayed on

the By site tab.

You can assign active and inactive devices to locations. If

you assign an inactive device, it stays inactive.

Partially locked, locked, and stopped devices are marked

with a status icon and status text.

The application detects unlicensed devices and marks

them with an icon. You cannot perform actions on

unlicensed devices.

The blood gas overview was updated:

• The compact and the expanded display were

updated.

13

Roche Diagnostics

cobas

®

infinity POC · Software version 2.0.1 · User Guide · Publication version 2.2

• You can configure a custom sort order for the blood

gas overview.

• You can directly access the messages and notes from

the blood gas device details and perform the

corresponding functions.

u About device status (55)

u Assigning a device (60)

u Blood gas devices (66)

Device management > Quality control

The QC families screen was updated:

• Additional columns providing more information were

added.

• The search options were updated.

• The filter criteria were extended.

You can export QC results from the QC families screen.

The alarms are directly displayed on the Proficiency

results screen.

u Searching for QC results (71)

u Exporting QC results (77)

u Viewing proficiency results (75)

Device management > Material lots

The filter criteria on the Material lots screen were

extended.

The lot details include the lot version for device types

supporting lot versions.

Information on default ranges was added.

u Searching for a lot (86)

u Viewing lot details (88)

u Creating a lot (90)

Device management > Settings

The application differentiates between user-specific and

newly added application-wide settings.

You can configure the following application-wide

settings:

• Manual or automatic lot management for a device

type.

• Absolute QC target deviations per QC lot version for

device types supporting lot versions.

u Creating a lot (90)

u Settings (95)

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Roche Diagnostics

cobas

®

infinity POC · Software version 2.0.1 · User Guide · Publication version 2.2

Operator management > Operators

Even if the certification status is valid, a tab of the

operator’s certification may display unfulfilled

certification criteria.

The operator ID can contain uppercase letters (A to Z),

numbers (0 to 9), and the additional characters +,/,_,-,$,

\,@.

u Searching for operators and viewing operator details

(101)

u Adding an operator (103)

Patient results > Result validation

The Result validation screen was updated:

• Additional columns providing more information were

added.

• The filter criteria were extended.

The patient result details include the visit details.

The following functions were added to the Result

validation screen:

• Change the associated patient for several unreviewed

results at once directly from the result list.

• Resend accepted results to the host.

• Unvalidate accepted results (if configured).

• Export results.

u Searching for patient results (115)

u Reviewing patient result details (117)

u Changing the patient associated with a result (119)

u Resending accepted results to the host (121)

u Unvalidating accepted results (122)

u Exporting results (124)

Reports > QC reports > Inbox

Reports are created in the language configured in the

personal settings of your user.

Numbers and dates are displayed in the format of your

web browser.

u Reviewing and signing a report (133)

Linearity reports

If 2 linearity results have been performed at the same

time (i.e., same time stamp down to the minute) and have

the same result for the same level, the linearity report

displays 1 of the results only.

This does not affect the calculated mean or the displayed

graph.

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Roche Diagnostics

cobas

®

infinity POC · Software version 2.0.1 · User Guide · Publication version 2.2

u List of reports (138)

Configuration > System > General settings

To secure the connection to the LDAP server, use

port636.

The following Results & Patients configuration options

for unvalidating results were added:

• Enable to unvalidate results.

• Enable to generate new sample IDs for unvalidated

results.

• Set the time period for unvalidating results.

The System configuration option to set a session

expiration time for automatic logoff can now be used. If

the value is set to 0, the automatic logoff is disabled.

u LDAP server name or IP address and port (176)

u Enable sample unvalidation (189)

u Generate new sample ID for unvalidated sample

(194)

u Timeframe for sample unvalidation (hours) (194)

u Session Expiration Time (Minutes) (198)

Start of daily routine (RiliBÄK)

To allow for timely reception and evaluation of the QC

results in the application and to prevent unfounded

triggering of the RBY1 alarm, configure the start of the

daily routine at least 5minutes before the time the QC

tests are done on the instruments.

u Instrument Alarm Definition (206)

u Configuration (305)

Configuration > System > Demographic

definition

The current name of demographic fields does not apply

to other screens.

u Demographic Definition (239)

Multisite concept

The information about the multisite concept was

updated.

u Multisite concept (250)

Configuration > User profiles > Edit menus

The list of entries on the Menus screen and their

descriptions were updated.

u Menus (263)

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Roche Diagnostics

cobas

®

infinity POC · Software version 2.0.1 · User Guide · Publication version 2.2

Editing notification templates

The information how to edit notification templates was

updated.

u Editing notification templates (296)

Configuration > Devices > EAP settings

import

You can import EAP settings from a file.

u EAP settings import (324)

Configuration > Quality control > Multi rules

The field definitions for multirules were added.

u Field definitions (341)

Roche Diagnostics

cobas

®

infinity POC · Software version 2.0.1 · User Guide · Publication version 2.2

Safety

1 Safety information.........................................................................................19

19

Table of contents

Roche Diagnostics

cobas

®

infinity POC · Software version 2.0.1 · User Guide · Publication version 2.2

Safety information

In this chapter

1

Safety classifications............................................................. 21

System safety........................................................................... 22

Safety information for IT managers................................. 24

Laboratory workflows........................................................... 28

Privacy protection .................................................................. 29

1 Safety information

20

Table of contents

Roche Diagnostics

cobas

®

infinity POC · Software version 2.0.1 · User Guide · Publication version 2.2

1 Safety information

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