Roche cobas IT 1000 User manual

cobas IT 1000 application

User Manual

Version 4.9

Software version 2.09

cobas IT 1000 application

Roche Diagnostics

2 User Manual · Version 4.9

Revision history

Manual version Software version Revision dates Main change

1.0 1.0 June 2004 Software update

2.0 1.05 June 2005 Software update

2.1 1.06 November 2005 Software update.

Alarm definitions

added.

2.2 1.07 February 2006 Software update

2.3 1.07.01 August 2006 Software update,

corrections

2.4 1.07.02 October 2006 Software update,

corrections

2.5 1.07.03 April 2007 Software update,

corrections

2.6 1.07.03_01 June 2007 Corrections

2.7 1.07.04 August 2007 Software update

2.8 1.07.05 November 2007 Software and manual

updates

2.9 1.08 February 2008 Software and manual

updates

3.0 1.09 May 2008 Software and manual

updates

3.1 1.09.01 October 2008 Software and manual

updates

3.2 1.09.02 December 2008 Software and manual

updates

3.3 1.10 March 2009 Software and manual

updates

3.4 1.11 June 2009 Software and manual

updates

3.5 1.12 November 2009 Software and manual

updates

3.6 1.13 February 2010 Software and manual

updates

3.7 1.14 June 2010 Software and manual

updates

3.8 1.14.00.02 October 2010 Software and manual

updates

3.9 2.0 June 2011 Software and manual

updates

4.0 2.00.01 April 2012 Software and manual

updates

4.1 2.01.00 March 2013 Software and manual

updates

4.2 2.02.00 November 2013 Software and manual

updates

4.3 2.03.00 June 2014 Software and manual

updates

Table 1 Revision history

Roche Diagnostics

User Manual · Version 4.9 3

cobas IT 1000 application

Editor’s note 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.

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.

Not in scope of intended use This product is not intended for the diagnosis, screening, monitoring or treatment of

patients.

4.4 2.04.00 December 2014 Software and manual

updates

4.5 2.05.00 June 2015 Software and manual

updates

4.6 2.06.00 November 2015 Software and manual

updates

4.7 2.07.00 June 2016 Software and manual

updates

4.8 2.08.00 December 2016 Software and manual

updates

4.9 2.09.00 June 2017 Software and manual

updates

Manual version Software version Revision dates Main change

Table 1 Revision history

cobas IT 1000 application

Roche Diagnostics

4 User Manual · Version 4.9

Features and Functionalities The main functions are:

o Receiving electronically: patient test results, quality control results, instrument

messages and instrument maintenance events

o Receiving manually: quality control results and comments

o Storing patient test results, quality control results, instrument messages and

instrument maintenance events

o Managing users & certifications

o Sending patient test results and quality control results to customer IT systems

(HIS&LIS)

o Assessment of patient and quality control results to support compliance with the

customer’s quality environment

o Configuring the workflow of connected instruments (for example configuring the

patient identification method on the instrument)

o Reporting

o 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).

o Support for cobas® infinity POC mobile and cobas® infinity POC tablet, access

granted through connection to cobas® infinity POC mobile adapter. cobas®

infinity POC mobile is an App that uses already existing cobas IT 1000

application data and displays it on a mobile device, information displayed covers:

POC devices, operators and certifications.

Before using the system, it is important to read this manual thoroughly.

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User Manual · Version 4.9 5

cobas IT 1000 application

Intended users

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.

CAUTION

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.

User group Description of use

(1)

(1) include potential system interfaces

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

View information generated by cobas IT 1000 application on

cobas® infinity POC mobile

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.

View information generated by cobas IT 1000 application on

cobas® infinity POC mobile and cobas® infinity

POC tablet

IT Manager WLAN device configuration security type EAP

EAP Settings management (EAP settings and EAP settings

assignment).

WLAN device configuration security type EAP

Table 2 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.

Table 3 User roles

cobas IT 1000 application

Roche Diagnostics

6 User Manual · Version 4.9

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.

Screenshots The screenshots 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 is fictitious and must not be used

for laboratory purposes.

War ranty 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.

Always leave software updates to a Roche Service representative, or perform such

updates with their assistance.

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

The cobas IT 1000 application may include components or modules that are

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 Recognized trademarks:

o ROCHE, ROCHE OMNI, ACCU-CHEK, ACCU-CHEK INFORM, ROCHE

CARDIAC, COBAS B, COBAS, COAGUCHEK and LIFE NEEDS ANSWERS are

trademarks of Roche.

o Roche and the Roche symbol are registered trademarks of the Roche group.

o 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

User Manual · Version 4.9 7

cobas IT 1000 application

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 3

rd

party products are available for use with the cobas IT 1000

application.

The complete list of Roche Diagnostics and 3

rd

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 3

rd

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

Manufacturer

Distributed in US by

What is new in publication version 4.9

Certification The documentation of the certification screen has been revised and extended.

u Certifications (p. 163)

You can configure the beginning of the notification period for certificate expiration.

u Notification about certification tasks (p. 183)

LMS input & user import file New instructions are provided about the use of double-quotes in the LMS input file

and the user import file for automated user import.

u Exam results input file (p. 172)

u Import file (p. 212)

E-mail notification Instructions are provided how to open attached CSV files.

u Notification Templates (p. 202)

User import The documentation of the certification screen has been revised and extended.

u Manual user import (p. 209)

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Switzerland

Roche Diagnostics

9115 Hague Road

Indianapolis, Indiana

USA

cobas IT 1000 application

Roche Diagnostics

8 User Manual · Version 4.9

The application supports automatic user import from a customer Human Resources

Management System.

u Importing user information automatically (p. 216)

A new screen for logging user import messages is available.

u Auto. User Import Log (p. 218)

Instrument synchronization You re-synchronize instruments on the Instruments > Status window.

u Synchronizing an instrument (p. 247)

Levey-Jennings chart New instructions are provided how to change the date range in the chart.

u Changing the date range in the Levey-Jennings chart (p. 308)

An additional Levey-Jennings Review by Lot screen with better performance is

available.

u Levey-Jennings Review by Lot (p. 315)

Quality control (RiliBÄK) On the Result Management window, the Block button and the Release button are no

longer available.

u Result Management screen (p. 334)

RMSE alarms (RiliBÄK) The supported RMSE alarms are provided in a table.

u RMSE Alarm Monitor (p. 358)

What is new in publication version 4.8

Front matter The front matter has been updated.

u Open Source and Commercial Software (p. 6)

Safety information The following safety message has been revised.

u (p. 21)

New warning The warning "Critical Instrument Events (unacknowledged)" has been added.

u My Settings > Warnings Configuration screen (p. 53)

u List of Warnings (p. 55)

Instrument alarm default security Instructions how to change the default security of alarms have been added.

u (p. 98)

Instrument alarm assignment Information about unassigned system alarms has been added.

u (p. 108)

Test definition Test abbreviations can now have max. 12 characters (before max. 8 characters).

u Test Definition screen (p. 119)

Certification The new certification parameter "Role" is now available.

u User role (p. 180)

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User Manual · Version 4.9 9

cobas IT 1000 application

LMS import errors A new menu to report LMS import errors has been added.

u LMS Import Errors (p. 200)

Material definition The note not to change the default value of the SD range has been added.

u Material Definition screen (p. 222)

The read-only field Validation Date/Time is explained.

Instrument grid symbols The symbols used in the instrument grid have been updated.

u Status (p. 245)

Event grid You can filter events now based on their severity level.

u Instruments > Status screen (p. 247)

User certification history The report field "Deactivation date" has been added.

u Example of User Certification History report (p. 432)

What is new in publication version 4.7

Update front matter The front matter has been updated.

u Copyright (p. 6)

u License information (p. 6)

u War ranty (p. 6)

u Open Source and Commercial Software (p. 6)

Online help The section on now to access the Online help has been revised.

u Online help (p. 16)

Safety information The system safety information has been revised and updated.

u System safety information (p. 19)

Login in with Network ID The manual describes how to log in with the Network ID.

u To login to the cobas IT 1000 application (p. 32)

https The manual explains how to log in when https is enabled.

u To login to the cobas IT 1000 application (p. 32)

Supported characters The supported characters for patient ID and visit ID have been extended.

u Business rules (p. 36)

Instrument alarms The user is instructed not to edit alarm texts.

u Instrument Alarm Definition (p. 98)

New alarms A new user alarm (OII), and a new patient alarm (PII) have been added.

u User alarms (system alarms) (p. 103)

u Patient alarms (system alarms) (p. 104)

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10 User Manual · Version 4.9

HIS Locations The manual describes when a manually entered description of a HIS Location is

overwritten.

u Description of HIS Location (p. 147)

LDAP and Network ID New information about the use of LDAP and the Network ID has been added.

u User Management (p. 158)

u Importing user information manually (p. 211)

Patient ID mapping A new safety message about changing patient ID mapping has been added.

u Device Configuration (p. 262)

Levey-Jennings Review by Lot The manual explains how assigning an instrument affects the counting of results in

the Result management screen, but not in the Levey-Jennings Review by Lot screen.

u Levey-Jennings Review by Lot screen (p. 315)

Effective QC range The manual explains how the lower and upper range limits of the QC range are

calculated.

u Calculation of lower and upper range limits (p. 364)

Results with invalid characters The manual notifies the user about the potential consequences of accepting results

containing invalid characters in the user ID and/or patient ID.

u Sample Validation (p. 370)

Invalid patient ID/visit ID A new safety message about the manual entry of Patient ID/Visit ID has been added.

u Single Patient Edit (p. 377)

LmsId Reference Field If the LmsId Reference Field is enabled, cobas IT 1000 application now identifies the

user solely by the Comment, Email, or User ID.

u Configurable formats (p. 439)

What is new in publication version 4.6

Intended use The intended use section has been updated.

u Intended use (p. 3)

u Features and Functionalities (p. 4)

u Intended users (p. 5)

Login after Silverlight installation The Manual describes how to start cobas IT 1000 application after installing

Silverlight.

u Initial steps (p. 31).

Filtering criteria The Manual describes the filtering function in the List area.

u Filtering (p. 42).

Printing Levey-Jennings charts The description of how to print Levey-Jennings charts has been extended.

u Printing Levey-Jennings charts (p. 314).

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User Manual · Version 4.9 11

cobas IT 1000 application

Result validation The manual describes the multi-select functionality in the Result validation screen.

u (p. 381).

What is new in publication version 4.5

Versions of Silverlight and

Internet Explorer on client

Higher version of Silverlight is needed, either in 32 bit or 64 bit version. Required

version of Internet Explorer added.

u System requirements (p. 27).

Warnings applicable to user access

rights

Only warnings applicable to the corresponding user profile and privileges can be

assigned to a user.

u Warnings Configuration (p. 53)

u Defining warnings for other users (p. 162).

Recently expired certification

timeframe (Days)

The default value of the Recently expired certification timeframe (Days) parameter

was changed to 60.

u Recently expired certification timeframe (Days) (p. 74)

New patient alarms Two new patient alarms were added:

o PD: Patient discharged

o PN: Patient not admitted

u Patient alarms (system alarms) (p. 104).

Operator lists for instruments Operators with certifications in status (long-time) expired are not downloaded to the

respective connected instruments requiring operator lists.

u Certification Tasks (p. 168)

u Certification (p. 175)

u User certifications (p. 194)

q

Operator lists are not available for all instruments.

Certification Tasks screen Information about required exams was added to the Certification Tasks screen. The

Reset academy counter button was renamed to Reset Exam Attempts button and is

now always enabled for exam tasks, even if cobas academy is not installed.

u Certification Tasks (p. 168).

Import of exam results to cobas IT

1000 application

Training courses in a 3

rd

party learning management system (LMS) can be set as

certification tasks in cobas IT 1000 application. Exam results of such training courses

can be imported to cobas IT 1000 application.

u Importing exam results from a 3rd party learning management system (LMS) (p. 171)

u Certification (p. 175)

Manual entry of test lots The manual entry of test lots for instruments using code key information has been

removed.

u Adding a new lot (p. 231).

cobas IT 1000 application

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12 User Manual · Version 4.9

Data display on Instruments

> Status screen

o The default filtering of the Event column on the Status screen was changed and

depends on the way the screen is accessed.

o The user name in the format “Last Name, First Name” is displayed as tooltip for

entries in the User Name column.

u Status (p. 245).

Field definitions for Result

Management screen (QC RiliBÄK)

The field definitions of the Detail area of the Result Management screen (QC

RiliBÄK) were added.

u Result Management (p. 333).

POCT Monthly Feedback report This report includes statistical information about QC results only if the control

material and lot remained unchanged during the reported calendar month.

u POCT Monthly Feedback (p. 427).

What is new in publication version 4.4

Safety information Safety information regarding WLAN communication were added.

u For details, see System safety information (p. 19).

Predefined user profiles New predefined user profiles were added to cobas IT 1000 application.

u For details, see User Profiles (p. 150).

EAP security It is possible to configure EAP security for WLAN communication between

instruments and cobas IT 1000 application.

u For details, see Device Configuration (p. 262), EAP Settings (p. 267), and EAP Settings

Assignment (p. 276).

q

WLAN communication using EAP security is not available for all instruments.

Manual result entry The manual entry of patient test results has been deleted.

u See Results & Patients (p. 367).

Content of reports For the 2008 Monthly Report and the User Statistics report, additional information

were added about the content of the reports.

u For details, see 2008 Monthly Report (p. 420) and User Statistics (p. 432).

The description of the report fields of the User Certification History report was

added.

u For details, see User Certification History (p. 431).

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User Manual · Version 4.9 13

cobas IT 1000 application

Table of contents

Revision history 2

Contact addresses 7

What is new in publication version 4.9 7

What is new in publication version 4.8 8

What is new in publication version 4.7 9

What is new in publication version 4.6 10

What is new in publication version 4.5 11

What is new in publication version 4.4 12

Table of contents 13

Conventions used in this manual 15

This document 15

Online help 16

Safety classifications 18

System safety information 19

Maintenance 21

Laboratory workflows 22

Third-party software 22

Understanding

cobas IT 1000 application

1 Software Overview

System requirements 27

Browser settings 29

Security concept 30

Initial steps 31

2 User Interface

Application screen overview 39

Software basics 45

Using cobas IT 1000 application

3 My Settings

Language 51

Warnings Configuration 53

Personalizations 58

4 System

General Settings 65

Demographic Definition 92

Demographic Assignment 94

Patient Demographic Assignment 96

Instrument Alarm Definition 98

Instrument Alarm Assignment 108

System Alarm Assignment 110

Comment Definition 112

Sample Type Definition 114

Tube Definition 116

Test Definition 118

Test Group Definition 125

Message Broker Monitor 130

5 Organization

Organization module components 135

Sites 136

Locations 141

HIS Locations 146

Workgroup Definition 148

User Profiles 150

User Management 158

Certification Tasks 168

Certification 175

Competencies 198

LMS Import Errors 200

Notification Templates 202

HIS Location Import 207

User import 209

Auto. User Import Log 218

6 Materials

Material Definition 221

Lot Management 224

7 Instruments

Status 245

Maintenance 251

Configuration 255

EAP Settings 267

EAP Settings Assignment 276

Instrument Assignment 279

Maintenance Definition 288

Comment Assignment 291

Off-Line Instruments 294

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14 User Manual · Version 4.9

cobas IT 1000 application

8 Quality Control

Quality Control module 299

Result Management 301

Levey-Jennings Chart 307

Cumulative Chart 310

Levey-Jennings Review 312

Levey-Jennings Review by Lot 315

Levey-Jennings Review by Lot (fast) 317

Linearity Review 318

Multirules 321

Manual Result Entry 324

QC Test Mapping 326

9 Quality Control (RiliBÄK)

Quality Control (RiliBÄK) module 331

Result Management 333

Levey-Jennings Chart 339

Cumulative Chart 341

Levey-Jennings Review 343

Manual Result Entry 346

RiliBÄK Test Assignment 348

Result Alarm Monitor 351

QC Test Mapping 355

RMSE Alarm Monitor 358

Effective QC Range Review 362

10 Results & Patients

Results & Patients module 369

Sample Validation 370

Patient Query 372

Single Patient Edit 377

Result Validation 381

Result Query 392

11 Reports

Report Generation 397

Report Log 400

Types of Reports 402

Appendix

12 Formats for exam results input files

Configurable formats 439

13 Glossary

Index

Index 447

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cobas IT 1000 application

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.

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 three purposes:

o It provides descriptions of the cobas IT 1000 application user interface elements.

o It provides step by step procedures to perform routine tasks.

o It provides information regarding various aspects of the cobas IT 1000

application.

The document consists of two main parts and an appendix.

o Understanding cobas IT 1000 application (p. 23).

An overview of the cobas IT 1000 application, a description of the user interface

and a description of the warnings and error messages.

o Using cobas IT 1000 application (p. 47).

Instructions on using the various software modules.

o Glossary (p. 441).

The list of used terms and their definitions

Symbol Meaning

u Cross-reference

p Procedure start

s Procedure end

o List item

q Tip

Safety alert

Table 4 Information symbols

Product name Abbreviation

cobas IT 1000 application Application

System

Table 5

cobas IT 1000 application

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16 User Manual · Version 4.9

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 help, in addition to the printable User

Manual.

RiliBÄK Installation of

cobas IT 1000 application for

Germany only

In Germany only, the RiliBÄK quality rules apply. To reflect this, a special RiliBÄK

installation of cobas IT 1000 application is available for Germany only. Therefore, all

RiliBÄK related content in this User Manual is taken from this RiliBÄK installation,

is applicable for Germany only and does not show in the standard installation.

Online help

The Online help provides quick access to help information on screen.

Context-sensitive help You can find specific information relevant to the currently active window by pressing

<F1> on the keyboard.

System help You can open the Online help on the first page and search for information about

cobas IT 1000 application.

Figure 1 Online help window

A Navigation area B Main area

A

B

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cobas IT 1000 application

Navigation area At the top, the Navigation area contains 3 buttons supporting different search

strategies as explained in the table below.

Main area The content of the Online help is shown on the right. Links to related topics are

highlighted by underlined blue text.

q

Only the English language pack is installed by default. To use context-sensitive help with a

different language, install the respective language pack. For more information on language

packs, contact Roche Service.

Accessing Online help

Online help provides context-sensitive help and system help to search for

information about cobas IT 1000 application.

p To access system help

1

Click the button in the Global area.

2

From the drop-down list, choose the System Help option.

The first page of the Online help is displayed.

Figure 2 Online help title page

s

p To access context-sensitive help

1

Open the window in cobas IT 1000 application for which you desire more

information.

2

Press <F1> on the keyboard to open the context-sensitive help.

Alternatively, click the button in the Global area and choose the Help option

in the drop-down list.

s

Button Description

Contents Table of content of the Online help opens

Index Search for topics based on a list of keywords

Search Full-text search within the Online help

Table 6 Search options

cobas IT 1000 application

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18 User Manual · Version 4.9

Safety classifications

The following safety information applies to the system and is listed in accordance

with ANSI Z535.6. 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.

Safety alert symbol

r The safety alert symbol alone promotes awareness to hazards that are generic or direct

the reader to safety information provided elsewhere in the document.

These symbols and signal words are used for specific hazards:

WARNING

Warning

r Indicates a hazardous situation which, if not avoided, could result in death or serious

injury.

CAUTION

Caution

r Indicates a hazardous situation which, if not avoided, could result in minor or moderate

injury.

NOTICE

Notice

r Indicates a hazardous situation which, if not avoided, may result in damage to the

system.

Important information that is not safety relevant is indicated with the following icon:

q

Tip

Indicates additional information on correct use or useful tips.

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cobas IT 1000 application

System safety information

Failure to observe the following safety information may result in incorrect results,

data corruption, and data losses.

CAUTION

Malicious software or unauthorized access can result in data loss or solution

unavailability.

To avoid infection by malicious software or the unauthorized access and misuse

of the solution, the following recommendations are essential:

r Do not install and/or execute unapproved software on the cobas IT 1000 server.

r It is the customer’s responsibility to ensure that other computers and services on the

network (for example, the LIS, archiving share, backup share, or service) are properly

secured and protected against malicious software and unauthorized access.

r Customers are responsible for the security of their local area network, especially in

protecting it against malicious software and attacks. This protection might include

measures, such as a firewall, to separate the server from uncontrolled networks as well

as measures that ensure that the connected network is free of malicious code.

r Make sure that access and queries to the database are properly secured and protected

against unauthorized access.

r Make sure that system backup and archive files are protected from any unauthorized

access and disaster, this includes: remote storage location; disaster recovery sites;

secure transfer of backup files.

r Prevent credential theft.

o Use strong passwords. Do not share your credentials (user account, password).Do

not write passwords down. Do not use the same credentials on multiple

applications.

o Change the default password at the first log-on.

CAUTION

Unauthorized access to the system

Unauthorized physical access to the system and attached IT infrastructure can

compromise the integrity and confidentiality of private data stored on the cobas IT 1000

server or on related removable media.

r Restrict physical access to the system to authorized persons.

r Physically protect the server running the application.

r Store related removable media in a safe place.

r Make sure that all device components maintaining private data are physically secure

(i.e. require a physical key to be accessed or removed).

r Implement security and authentication measures for removable media (i.e. USB drives,

CD-Rom/DVD, tapes, etc.).

CAUTION

Unauthorized access to confidential data

Unencrypted communication can lead to unauthorized access to confidential data.

r Use encrypted communication channels from the application.

o Enable HTTPS (HTTP over TLS).

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20 User Manual · Version 4.9

CAUTION

Unauthorized access to the system configuration

Unauthorized access to the system configuration (administration interface, configuration

store, query packages) can lead to system failure, corrupted data, and unauthorized

disclosure of protected health information.

r Make sure that the system configuration is properly secured and protected against

unauthorized access.

CAUTION

Sensitive data - data tampering in transmission

Unprotected Wi-Fi connections between instruments and the cobas IT 1000 application

can lead to unauthorized data access and tampering.

r Make sure that your Wi-Fi connections are properly secured.

o If supported, use EAP security for Wi-Fi connections.

CAUTION

Data loss and disaster recovery

Unexpected disasters, such as hard disk failures, system software failures or natural

disasters such as fires or floods can occur.

r The Customers IT department must assemble a disaster recovery kit to protect the

entire system.

r Ensure that backups are made regularly (ideally ever day) and stored securely.

WARNING

Blocked operator access to POC devices

If the application is compromised by a malicious attacker, operator access to connected

POC devices can be blocked. To avoid delayed results due to blocked operator access, do

the following:

r Assess the impact of availability of each connected POC device on patient safety. If

necessary, implement suitable risk control measures, or manually managed off-line

devices.

NOTICE

Data transmission is not secured

Unsecured communication can compromise the integrity and confidentiality of the

transmitted data. It is the customer's responsibility to ensure that the network

infrastructure provides appropriate protection for the transmitted data.

r Such protection can be achieved by system level tunneling protocols or other means of

network encryption.

NOTICE

Data is not encrypted

Data in the database is not encrypted. It is the customer's responsibility to ensure that

access to the data storage and backup files is permitted only to authorized entities.

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Roche cobas IT 1000 User manual

Roche cobas IT 1000 User manual

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