Roche cobas IT 1000 User manual

cobas IT 1000 application

User Manual

Version 4.7

Software version 2.07.00

cobas IT 1000 application

Roche Diagnostics

2 User Manual · Version 4.7

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 4.7 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.

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

o Reporting

o Support for cobas® infinity POC mobile, 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.

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

Manual version Software version Revision dates Main change

Table 1 Revision history

cobas IT 1000 application

Roche Diagnostics

4 User Manual · Version 4.7

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.

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.

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

thecustomer’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

thecustomer’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

ccobas® infinity POC mobile

IT Manager WLAN device configuration security type EAP

EAP Settings management (EAP settings and EAP

settingsassignment).

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

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User Manual · Version 4.7 5

cobas IT 1000 application

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 of commercial

or open-source software. For further information on the intellectual property and

other warnings, as well as licenses pertaining to the software programs included in

the cobas IT 1000 application, refer to the electronic distribution included with this

product.

This open source and commercial software and the cobas IT 1000 application as a

whole can constitute a device regulated in accordance with applicable law. For more

detailed information, refer to the user manual and labeling.

Please note that the respective authorization is no longer valid according to the

corresponding legislation should any unauthorized changes be made 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.

cobas IT 1000 application

Roche Diagnostics

6 User Manual · Version 4.7

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

US Distribution

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. 17).

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

u For details, see User Profiles (p. 146).

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. 251), EAP Settings (p. 256), and EAP Settings

Assignment (p. 265).

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. 355).

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Switzerland

Roche Diagnostics

9115 Hague Road

PO Box 50457

Indianapolis, IN 46250-0457

USA

Roche Diagnostics

User Manual · Version 4.7 7

cobas IT 1000 application

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. 408) and User Statistics (p. 419).

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

added.

u For details, see User Certification History (p. 418).

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. 25).

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. 51)

u Defining warnings for other users (p. 158).

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. 72)

New patient alarms Two new patient alarms were added:

o PD: Patient discharged

o PN: Patient not admitted

u Patient alarms (system alarms) (p. 101).

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. 164)

u Certification concept (p. 173)

u User Certifications (p. 191).

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. 164).

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. 167)

u Certification details (p. 174).

cobas IT 1000 application

Roche Diagnostics

8 User Manual · Version 4.7

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. 219).

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. 233).

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. 321).

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. 416).

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. 3)

u Intended users (p. 4)

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

Silverlight.

u Initial steps (p. 29).

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

u Filtering (p. 40).

LMS exam results imports The manual explains how to avoid failed LMS exam results imports.

u Correcting failed imports of exam results (p. 169).

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

u Printing Levey-Jennings charts (p. 302).

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

u (p. 369).

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User Manual · Version 4.7 9

cobas IT 1000 application

What is new in publication version 4.7

Update front matter The front matter has been updated.

u Copyright (p. 5)

u License information (p. 5)

u War ranty (p. 5)

u Open Source and Commercial Software (p. 5)

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

u Online help (p. 14)

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

u System safety information (p. 17)

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. 30)

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

u To login to the cobas IT 1000 application (p. 30)

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

u Business rules (p. 34)

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

u Instrument Alarm Definition (p. 95)

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

u User alarms (system alarms) (p. 100)

u Patient alarms (system alarms) (p. 101)

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

overwritten.

u Description of HIS Location (p. 143)

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

u User Management (p. 154)

u Importing user information (p. 204)

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

u Device Configuration (p. 251)

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. 303)

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10 User Manual · Version 4.7

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. 353)

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. 358)

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. 365)

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 Formatting for the LMS input file (p. 425)

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User Manual · Version 4.7 11

cobas IT 1000 application

Table of contents

Revision history 2

Contact addresses 6

What is new in publication version 4.4 6

What is new in publication version 4.5 7

What is new in publication version 4.6 8

What is new in publication version 4.7 9

Table of contents 11

Conventions used in this manual 13

This document 13

Online help 14

Safety classifications 16

System safety information 17

Maintenance 18

Laboratory workflows 19

Third-party software 19

Understanding

cobas IT 1000 application

1 Software Overview

System requirements 25

Browser settings 27

Security concept 28

Initial steps 29

2 User Interface

Application screen overview 37

Software basics 43

Using cobas IT 1000 application

3 My Settings

Language 49

Warnings Configuration 51

Personalizations 56

4 System

General Settings 63

Demographic Definition 89

Demographic Assignment 91

Patient Demographic Assignment 93

Instrument Alarm Definition 95

Instrument Alarm Assignment 105

System Alarm Assignment 107

Comment Definition 109

Sample Type Definition 111

Tube Definition 113

Test Definition 115

Test Group Definition 122

Message Broker Monitor 127

5 Organization

Organization module components 131

Sites 132

Locations 137

HIS Locations 142

Workgroup Definition 144

User Profiles 146

User Management 154

Certification Tasks 164

Certification 171

Competencies 195

Notification Templates 197

HIS Location Import 201

User Import 203

6 Materials

Material Definition 209

Lot Management 212

7 Instruments

Status 233

Maintenance 240

Configuration 244

EAP Settings 256

EAP Settings Assignment 265

Instrument Assignment 268

Maintenance Definition 277

Comment Assignment 280

Off-Line Instruments 283

8 Quality Control

Quality Control module 287

Result Management 289

Levey-Jennings Chart 295

Cumulative Chart 298

Levey-Jennings Review 300

Levey-Jennings Review by Lot 303

Linearity Review 305

Multirules 308

Manual Result Entry 311

QC Test Mapping 313

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12 User Manual · Version 4.7

cobas IT 1000 application

9 Quality Control (RiliBÄK)

Quality Control (RiliBÄK) module 319

Result Management 321

Levey-Jennings Chart 328

Cumulative Chart 330

Levey-Jennings Review 332

Manual Result Entry 335

RiliBÄK Test Assignment 337

Result Alarm Monitor 340

QC Test Mapping 344

RMSE Alarm Monitor 347

Effective QC Range Review 351

10 Results & Patients

Results & Patients module 357

Sample Validation 358

Patient Query 360

Single Patient Edit 365

Result Validation 369

Result Query 380

11 Reports

Report Generation 385

Report Log 388

Types of Reports 390

Appendix

12 Formats for exam results input files

Configurable formats 425

13 Glossary

Index

Index 433

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User Manual · Version 4.7 13

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:

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. 21).

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. 45).

Instructions on using the various software modules.

o Glossary (p. 427).

The list of used terms and their definitions

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.

Symbol Meaning

u Cross-reference

p Procedure start

s Procedure end

o List item

q Tip

Safety alert

Table 4 Information symbols

cobas IT 1000 application

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14 User Manual · Version 4.7

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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User Manual · Version 4.7 15

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 opens.

Figure 2 Online help title page

s

p To acces 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 5 Search options

cobas IT 1000 application

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16 User Manual · Version 4.7

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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User Manual · Version 4.7 17

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.

o Do not share passwords.

o Do not write passwords down.

o Do not use the same credentials on multiple instruments.

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 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 in properly secured and protected against

unauthorized access.

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18 User Manual · Version 4.7

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.

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.

Maintenance

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

data corruption, and data losses.

CAUTION

Data loss or damage to the system due to power failure

r Ensure regular maintenance of the uninterruptible power supply.

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User Manual · Version 4.7 19

cobas IT 1000 application

Laboratory workflows

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

data corruption, and data losses.

WARNING

Incorrect results due to expired calibration and quality controls

r Perform regular quality controls and calibrations.

WARNING

Incorrect results due to incorrect entry

r Ensure that manually entered data is correct.

CAUTION

Incorrect results due to incomplete patient data

Patient results can only be correctly validated if all of the required patient data is stored in

the system.

r In case of incomplete transmission of patient data through the Hospital Information

System, tests may have to be repeated.

CAUTION

Unreliable validation due to unauthorized changes to the validation settings

r The manufacturer is not liable for any consequences whatsoever resulting from

subsequent, unauthorized modifications to accepted validation settings included in the

system upon customer request.

Third-party software

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

data corruption, and data losses.

CAUTION

Malfunctions and incorrect results due to third-party software

The installation of any third-party software that has not been approved by Roche

Diagnostics International Ltd may lead to malfunctions.

r Do not install any unapproved software.

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20 User Manual · Version 4.7

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