Roche cobas IT 1000 User manual

cobas IT 1000 application

Instructions for Use

COBAS and LIFE NEEDS ANSWERS are

trademarks of Roche.

RocheDiagnostics Ltd.

CH-6343 Rotkreuz

Roche Diagnostics

Instructions for Use · Version 3.9 2

cobas IT 1000 application

Revision History

Manual Version Software Version Revision Date Changes

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 user

manual updates

2.9 1.08 February 2008 Software and user

manual updates

3.0 1.09 May 2008 Software and user

manual updates

3.1 1.09.01 October 2008 Software and user

manual updates

3.2 1.09.02 December 2008 Software and user

manual update

3.3 1.10 March 2009 Software and user

manual update

3.4 1.11 June 2009 RiliBÄK 2008

updates

3.5 1.12 November 2009 Software and user

manual update

3.6 1.13 February 2010 Software and user

manual update

3.7 1.14 June 2010 Software and user

manual update

3.8 1.14.00.02 October 2010 Software and user

manual update

3.9 2.0 June 2011 Software and user

manual update

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3 Instructions for Use · Version 3.9

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

manual is correct at the time of printing. However, Roche Diagnostics GmbH

reserves the right to make any changes necessary without notice as part of ongoing

product development.

Software updates are done by Roche Service representatives.

Intended use The cobas IT 1000 application is a data management software solution for managing

professional Point of Care Testing. Its main functions are:

o Receiving patient test results and quality control results (electronically or

manually).

o Receiving instrument messages and instrument maintenance events.

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

instrument maintenance events.

o Managing users and user certificaion.

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

o Validating patient test results and quality control results according to customer

selected criteria.

o Configuring the workflow of connected instruments.

o Reporting

It is important to read this manual thoroughly before using the system.

Trademarks Recognized trademarks:

o ROCHE, ROCHE OMNI, ACCU-CHEK, ROCHE CARDIAC, COBAS B,

COBAS 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 fulfils 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.

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cobas IT 1000 application

Contact addresses

Manufacturer

US Distribution

Roche Diagnostics Ltd.

Forrenstrasse

CH-6343 Rotkreuz

Switzerland

www.roche.com

Roche Diagnostics Corporation

9115 Hague Road

PO Box 50457

Indianapolis, IN 46250-0457

USA

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Using this manual

This manual is available in printed and electronic form. You can find detailed

information on each window, and the functions you can perform there, by pressing

F1 to display the Help.

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.

Following are symbols and conventions used in this manual.

Symbols The following symbols may be used to draw your attention to important information:

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 on page A-1. This includes 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 on page B-1. This includes instructions on using the various

software modules.

o Glossary on page C-3. This includes the list of used terms and their definitions.

o Keep this manual in a place where it will not be damaged.

o Ensure that this document is available at all times.

Symbol Meaning

Note.

f Location in the software where the

procedure can be performed.

a Start procedure.

o List item.

e Cross reference.

 Procedure end.

Ta bl e 1 Authoring symbols used in this manual

cobas IT 1000 application

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7 Instructions for Use · Version 3.9

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 (Instructions for Use). Following are the explanations on what the Help

consists of and how to use it.

Help

The cobas IT 1000 application has a context sensitive Help feature to assist working

with the system. “Context sensitive” means from wherever within the cobas IT 1000

application, choosing the Help feature displays help text or a screen shot related to

this area of the software. The Help offers a quick and convenient way to find

information, such as explanations of screens and dialog boxes as well as explanations

on how to perform particular tasks.

You can access the Help either by pressing F1 on the keyboard, or by clicking the

Help button in the Button Area. You can then select either the context sensitive help

or a general table of contents, under System Help.

e

User Interface on page A-13

The context sensitive entry displays text or a screenshot relating to the current

location in the software.

The Help window This window is made up of three main areas:

o Button bar

o Navigation pane

o Topic pane

Button bar

The button bar has the buttons described below:

Navigation pane

The navigation pane appears to the left of the Help window. There are four tabs

available at the top of the pane: Contents, Index, Search and Favorites.

The Contents tab uses books and page icons to display the contents of cobas IT 1000

application Help. The Index tab provides access to the Help index, the Search tab

provides access to a full-text search feature. Finally, the Favorites tab allows users to

store a list of their most-frequently used help topics.

Note that the above three references link to the first page of each part only.

Show in Contents

Locates the currently displayed topic in the navigation

pane.

Related Topics

Use this button to display the topics related with the topic

currently displayed in the topic pane.

E-mail

E-mail the currently displayed topic to a mail recipient.

Print

Prints the topic currently displayed in the topic pane.

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Topic pane

Help topics appear in the pane to the right of the navigation pane. If the topic extends

beyond the window, scrollbars allow you to view the rest of the topic.

Links to associated topics are indicated by underlined blue text. When you point to a

link, the mouse pointer changes to a hand shape.

a To display general Help

1

In the cobas IT 1000 application software, click the Help icon in the Global

Action Area

2

Select System Help from the list.

The cobas IT 1000 application help opens displaying the appropriate Help topic

in the topic pane.

a To display context-sensitive Help

1

In the cobas IT 1000 application software, select the screen for which you want

detailed information.

2

Click the Help icon in the Global Action Area and select Help from the list or

press <F1> on the keyboard.

The cobas IT 1000 application help opens displaying the appropriate Help topic

in the topic pane.

Searching for Help topics There are various ways you can find the information you need in the cobas IT 1000

application help system. The Contents tab displays the structure and contents of the

help system allowing you to navigate to the desired location. The Index tab displays a

list of predefined keywords based on the topic titles and words or phrases in the help

system. The Search tab allows you to perform a full-text search.

a To use the Contents tab

1

Click the Help icon in the Global Action Area and select Help from the list or

press <F1> on the keyboard.

2

In the navigation pane, double-click the book icon for the screen for which you

require more information. The structure in the navigation pane expands showing

the available information.

3

Select the required page, or click a book to further expand the contents structure.

When a page is chosen, the topic pane displays the appropriate topic.

a To use the Index tab

1

Click the Help icon in the Global Action Area and select Help from the list or

press <F1> on the keyboard.

2

Click the Index tab to display the list of index entries.

3

Enter the desired index entry or scroll through the index list. As soon as you start

typing the index entry, the entries that most closely match the text that you type

are displayed in the index list.

cobas IT 1000 application

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9 Instructions for Use · Version 3.9

4

When you have found the desired index entry, double-click the entry or select the

entry followed by Display to display the topic in the topic pane.

a To use the Search tab

1

Click the Help icon in the Global Action Area and select Help from the list or

press <F1> on the keyboard.

2

Click the Search tab.

3

In the first text box, enter the word(s) that you want to find and click Go or press

<Enter> to make the search.

Matching topic titles are displayed in the list below.

4

Click the title of the topic to display it in the topic pane.

Printing Help topics You may find it useful to print a specific topic in the cobas IT 1000 application Help.

a To print out Help topics

1

Click the Help icon in the Global Action Area and select Help from the list or

press <F1> on the keyboard.

2

Search for or navigate to the desired topic.

3

To print the current topic, click the Print button on the button bar.

The Print dialog-box opens.

4

Check that the correct printer is selected and click OK.

The selected topic is printed out.

Saving favorite Help topics You may find it useful to save your favorite help topics in the cobas IT 1000

application Help.

a To save favorite Help topics

1

Click the Help icon in the Global Action Area and select Help from the list or

press <F1> on the keyboard.

2

Search for or navigate to the desired topic.

3

To save the current topic as favorite, click the Favorite tab.

The current topic title is displayed on the current page text box.

4

Click Add.

The current page is added to the favorite list.

a To view favorite Help topics

1

Click the Help icon in the Global Action Area and select Help from the list or

press <F1> on the keyboard.

2

Click the Favorites tab to display the list of favorite topics.

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3

Double-click the entry or select the entry followed by Display to display the topic

in the topic pane.

a To delete favorite Help topics

1

Select the topic you wish to delete.

2

Click Delete.

a To view favorite Help topics

1

Click the Help icon in the Global Action Area and select Help from the list or

press <F1> on the keyboard.

2

Click the Favorites tab to display the list of favorite topics.

3

Select the entry that you want to delete from the list.

4

Click Remove

The list is deleted from the favorite list.

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Safety classifications

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

with ANSI Z535.6-2006. The Danger safety classification to indicate a situation that

will result in injury or death is not applicable to this system and is therefore not listed.

System Safety

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

data corruption, and data losses.

WARNING

Warning

Indicates a potentially dangerous situation which, if ignored, may lead to fatal or severe

injuries.

CAUTION

Caution

Indicates a potentially dangerous situation which, if ignored, may lead to injuries and/or

damage to property.

NOTIC E

Notice

Indicates a message not related to personal injury.

CAUTION

Incorrect or corrupt data resulting from incorrect operation or the use of wrong

modules

o Use only computers, monitors, printers, and accessories in accordance with the

manufacturer’s recommendations.

o Service your computer regularly (defragment the hard disk; install, run and update

antivirus software; and check for system error entries in the warning display).

CAUTION

Corrupt data due to viruses

Ensure that your infrastructure is protected by a firewall, maintain up to date antivirus

software and keep your operating systems up to date.

CAUTION

Incorrect or corrupt data due to unauthorized access and changes done

Access to your data and the configuration should only be granted to authorized users. All

user interventions are logged in the system.

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Data security

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

data corruption, and data losses.

Maintenance

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

data corruption, and data losses.

CAUTION

Unauthorized access and data loss due to malicious software and hacker attacks

Portable storage media can be infected with and transmit computer malware, which may

be used to gain unauthorized access to data or cause unwanted changes to software.

The product itself is not additionally protected against malicious software and hacker

attacks.

Customers are responsible for the security of their IT infrastructure and for protecting it

against malicious software and hacker attacks. Failure to do so may result in data loss or

render the product unusable.

Roche recommends the following precautions:

Allow connection of authorized external devices only.

o Ensure that all external devices are protected by appropriate security software.

o Ensure that access to all external devices is protected by appropriate security

equipment.

o Do not copy or install any software on the server unless it is part of the system software

or you are instructed to do so by a Roche service representative.

o If additional software is required on the server, contact your Roche service

representative to ensure validation of the software in question.

o Do not use the USB ports on the server to connect other storage devices unless you

are instructed to do so by official user documentation or a Roche service

representative.

o Exercise utmost care when using external storage devices such as USB flash drives,

CDs, or DVDs. Do not use them on public or home computers while connecting to the

computer.

o Keep all external storage devices in a secure place and ensure that they can be

accessed by authorized persons only.

CAUTION

Data loss

Back up your data at regular intervals (ideally every day).

CAUTION

Data loss or damage to the system due to power failure.

Ensure regular maintenance of the uninterruptable power supply.

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Laboratory workflows

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

data corruption, and data losses.

Third-party software

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

Perform regular quality controls and calibrations.

WARNING

Incorrect results due to incorrect entry

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. 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.

The manufacturer shall not be liable for any consequences whatsoever resulting from

subsequent, unauthorized modifications to accepted validation settings included in the

system upon customer request.

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 may lead to malfunctions. Do not install any unapproved software.

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14 Instructions for Use · Version 3.9

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Table of contents

Revision History 2

Editor’s note 3

Contact addresses 4

Using this manual 6

Conventions used in this manual 6

This Document 7

Help 7

Safety classifications 11

System Safety 11

Data security 12

Maintenance 12

Laboratory workflows 13

Third-party software 13

Understanding cobas IT 1000 Part A

1 Software Overview

System Requirements A-5

Security Concept A-6

Initial Steps A-7

Pop-up Message Description A-9

Module Descriptions A-10

Business Rules A-11

2 User Interface

Application screen overview A-15

Using the cobas IT 1000 application A-15

Using cobas IT 1000 Part B

3My Settings

Language B-5

Warnings Configuration B-7

Restrictions B-11

4System

General Settings B-17

Demographic Definition B-31

Demographic Assignment B-32

Instrument Alarm Definition B-36

Instrument Alarm Assignment B-42

System Alarm Assignment B-43

Comment Definition B-44

Sample Type Definition B-45

Tube Definition B-46

Test Definition B-48

Test Group Definition B-54

Message Broker Monitor B-58

5 Organization

Sites B-63

Locations B-64

HIS Locations B-66

Workgroup Definition B-67

User Profiles B-68

User Management B-74

User Certification B-79

HIS Location Import B-85

User Import B-87

6 Material

Material Definition B-91

Lot Management B-94

7 Instruments

Status B-102

Configuration B-109

Instrument Assignment B-118

Maintenance Definition B-126

Comment Assignment B-128

Off-Line Instruments B-129

8 Supported instruments details

Instrument Connection B-137

Connectable Instruments B-137

General Recommendations B-138

Accu-Chek Inform B-138

Accu-Chek Inform II system B-148

CoaguChek® XS Plus system B-165

CoaguCheck XS Pro system B-174

cobas b 123 POC system B-186

cobas b 221 system/Roche OMNI S system B-190

cobas b 121 system/Roche OMNI C system B-194

cobas h 232 POC system B-196

Urisys 1100 B-206

9 Quality Control

Results Management B-213

Levey-Jennings Chart B-217

Cumulative Chart B-219

Levey-Jennings Review B-220

Linearity Review B-222

Multirules B-224

Manual Result Entry B-226

QC Test Mapping B-227

10 Quality Control (RiliBÄK 2008)

Results Review B-233

Levey-Jennings Chart B-238

Cumulative Chart B-240

Levey-Jennings Review B-241

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Manual Result Entry B-242

RiliBÄK Test Assignment B-244

Result Alarm Monitor B-246

QC Test Mapping B-249

RMSE Alarm Monitor B-251

11 Results & Patients

Sample Validation B-257

Manual Result Entry B-258

Patient Query B-261

Single Patient Edit B-264

Result Validation B-267

Result Query B-277

12 Reports

Report Generation B-281

Report Log B-283

Types of Reports B-284

Appendix Part C

Glossary C-3

1 Software Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

2 User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-13

Understanding cobas IT 1000

A

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cobas IT 1000 application 1 Software Overview

Table of contents

Software Overview

This chapter is an overview of the entire application. It contains a short description of

the purpose and main functions of each of the modules in this application, and the

main workflow principles that are applicable through all the modules.

Note that only the following characters are allowed in the patient ID. Using other

characters might lead to a result mismatch:

0-9, A-Z, a-z,_,-

System Requirements ..................................................................................................... A-5

Browser settings ........................................................................................................ A-5

Security Concept ............................................................................................................. A-6

Initial Steps ....................................................................................................................... A-7

Login ........................................................................................................................... A-7

Change User Password ...................................................................................... A-8

Predefined Configurations ...................................................................................... A-9

Pop-up Message Description ......................................................................................... A-9

Warning Messages .................................................................................................... A-9

Error Messages .......................................................................................................... A-9

Information Messages ............................................................................................ A-10

Confirmation Messages ......................................................................................... A-10

Module Descriptions .................................................................................................... A-10

Business Rules ................................................................................................................ A-11

In this chapter

Chapter

1

Roche Diagnostics

A-4 Instructions for Use · Version 3.9

1 Software Overview cobas IT 1000 application

Table of contents

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Roche cobas IT 1000 User manual

Roche cobas IT 1000 User manual

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