Roche cobas IT 1000 User manual

cobas IT 1000 application

User Manual

Version 4.4

Software version 2.04.00

Roche Diagnostics

User Manual · 4.4 3

cobas IT 1000 application

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

Table 1 Revision history

cobas IT 1000 application

Roche Diagnostics

4 User Manual · 4.4

Editor’s note This manual is for users of the cobas IT 1000 application.

Every effort has been made to ensure that the information contained in this manual is

accurate at the time of printing. Not all functionality described in this manual may be

available to all users. Roche Diagnostics International Ltd reserves the right to make

any further required changes to software without prior notice. Such changes may not

immediately be reflected in this document.

Software updates are done by Roche Service representatives.

Intended use This document is intended for the users of the cobas IT 1000 application, User

Manual version 4.4.

The cobas IT 1000 application is a data management software system for managing

professional Point of Care testing. It is used to collect test results and associated data,

and to evaluate the data based on user-configurable criteria. The system 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 laboratory personnel.

The professional personnel can review data coming from multiple devices, verify

whether the 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.

Main functions The main functions of the cobas IT 1000 application are:

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

messages and instrument maintenance events

o Manual entry of quality control results

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

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

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

4.2 2.02.00 November 2013 Software and manual

updates

4.3 2.03.00 June 2014 Software and manual

updates

4.4 2.04.00 December 2014 Software and manual

updates

Manual version Software version Revision dates Main change

Table 1 Revision history

Roche Diagnostics

User Manual · 4.4 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.

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.

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.

User group Description of use

Nurse Manual entry of quality control results, instrument messages

Entry of test material data (lot no., expiration date)

Typical role: Operator

POC Coordinator Retrospective assessment of patient and quality control results to

support compliance with the customer's quality environment

Entry of test material data (lot no., expiration date)

Adaptation of the configuration of the application

Configuration of connected instruments

Typical role: User

IT Manager WLAN device configuration security type EAP

EAP Settings management (EAP settings and EAP settings

assignment).

Typical role: IT Manager

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 · 4.4

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 version 4.4

Safety information Safety information regarding WLAN communication were added.

U For details, see System safety information (p. 16).

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

U For details, see User Profiles (p. 142).

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. 238), EAP Settings (p. 243), and EAP Settings

Assignment (p. 252).

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. 341).

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Switzerland

Roche Diagnostics Corporation

9115 Hague Road

PO Box 50457

Indianapolis, IN 46250-0457

USA

Roche Diagnostics

User Manual · 4.4 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. 394) and User Statistics (p. 405).

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

added.

U For details, see User Certification History (p. 404).

cobas IT 1000 application

Roche Diagnostics

8 User Manual · 4.4

Roche Diagnostics

User Manual · 4.4 9

cobas IT 1000 application

Table of contents

Revision history 3

Contact addresses 6

What is new in version 4.4 6

Table of contents 9

Using this manual 11

This document 11

Online help 12

Safety classifications 15

System safety information 16

Maintenance 17

Laboratory workflows 18

Third-party software 18

Understanding

cobas IT 1000 application

1 Software Overview

System requirements 23

Browser settings 24

Security concept 25

Initial steps 26

2 User Interface

Application screen overview 33

Software basics 39

Using cobas IT 1000 application

3 My Settings

Language 45

Warnings Configuration 47

Personalizations 52

4 System

General Settings 59

Demographic Definition 85

Demographic Assignment 87

Patient Demographic Assignment 89

Instrument Alarm Definition 91

Instrument Alarm Assignment 101

System Alarm Assignment 103

Comment Definition 105

Sample Type Definition 107

Tube Definition 109

Test Definition 111

Test Group Definition 118

Message Broker Monitor 123

5 Organization

Organization module components 127

Sites 128

Locations 133

HIS Locations 138

Workgroup Definition 140

User Profiles 142

User Management 150

Certification Tasks 159

Certification 163

Competencies 183

Notification Templates 185

HIS Location Import 190

User Import 192

6 Materials

Material Definition 197

Lot Management 200

7 Instruments

Status 221

Maintenance 227

Configuration 231

EAP Settings 243

EAP Settings Assignment 252

Instrument Assignment 255

Maintenance Definition 264

Comment Assignment 267

Off-Line Instruments 270

8 Quality Control

Quality Control module 275

Result Management 277

Levey-Jennings Chart 283

Cumulative Chart 285

Levey-Jennings Review 287

Levey-Jennings Review by Lot 290

Linearity Review 291

Multirules 294

Manual Result Entry 297

QC Test Mapping 299

Roche Diagnostics

10 User Manual · 4.4

cobas IT 1000 application

9 Quality Control (RiliBÄK)

Quality Control (RiliBÄK) module 305

Result Management 307

Levey-Jennings Chart 314

Cumulative Chart 316

Levey-Jennings Review 318

Manual Result Entry 321

RiliBÄK Test Assignment 323

Result Alarm Monitor 326

QC Test Mapping 330

RMSE Alarm Monitor 333

Effective QC Range Review 337

10 Results & Patients

Results & Patients module 343

Sample Validation 344

Patient Query 346

Single Patient Edit 351

Result Validation 355

Result Query 366

11 Reports

Report Generation 371

Report Log 374

Types of Reports 376

Appendix

12 Glossary

Index

Index 415

Roche Diagnostics

User Manual · 4.4 11

cobas IT 1000 application

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 or by clicking the help button to display the Help.

Ensure the following:

Q

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

o Ensure that this document is available at all times.

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:

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.

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

Roche Diagnostics

12 User Manual · 4.4

The document consists of two main parts and an appendix.

o Understanding cobas IT 1000 application (p. 19).

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. 41).

Instructions on using the various software modules.

o Glossary (p. 409).

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.

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 a quick and convenient way to access help information on

screen.

Context sensitive help The cobas IT 1000 application has a context sensitive online help feature. When

choosing the Help feature, the Help opens on the topic related to the currently active

screen.

System help You can also open the online help on the first page. This feature is called System

Help.

Q

F1 only opens context sensitive help, if the respective language pack has been installed.

For more information on language packs contact your system administrator or Roche

Service.

The English language pack is installed by default.

Accessing the online help

To access the system help

P Accessing the system help

1

In the cobas IT 1000 application, click Help in the Global area.

2

From the pop-up list, choose System Help. The help window opens displaying

the first page of the online help.

U To see a screenshot and to gain an overview of the application screen, see Application

screen overview (p. 33)

S

Roche Diagnostics

User Manual · 4.4 13

cobas IT 1000 application

To access the context-sensitive help

P Accessing the context-sensitive help

1

In the cobas IT 1000 application, open the screen for which you want detailed

information.

2

To open context sensitive help, choose one of the following options:

o Press <F1> on the keyboard.

or,

o In the Global area, click Help. From the pop-up list, choose Help.

The cobas IT 1000 application help is displayed.

S

Help window layout

The Help window contains three areas:

Figure 1 Online help window

A Global area C Main area

B Navigation area

A

B

C

cobas IT 1000 application

Roche Diagnostics

14 User Manual · 4.4

Global area The Global area (A) contains the following elements:

Main area The Main area (C) appears on the right hand side of the Navigation area. It displays

the actual content of the help. Links to associated topics are indicated by underlined

blue text.

Navigation area The Navigation area (B) appears on the left hand side of the Help window. The tabs

Contents, Index, Search and Favorites each represent a different approach to

finding information.

Buttons Functions

Show in Contents button. Locates and

highlights the currently displayed topic in the

Navigation area.

Previous button. Goes to the previous topic

in the Navigation area.

Next button. Goes to the next topic in the

Navigation area.

Print button. Opens the print dialog to print

the currently displayed help topic.

Bookmark button. Bookmarks the current

page. Saves the bookmark in the favorites

folder of your internet browser.

Table 5 Help buttons

Tabs Functions

The Contents tab displays the table of

contents of the online help.

The Index tab is used to search the help

content by predefined keywords.

The Search tab allows you to perform a full-

text search on the help content.

The Favorites tab allows you to store a list of

the most-frequently used help topics in the

Navigation area.

Use the Add to Favorites button to add the

currently displayed help page to your

favorites.

Table 6 Navigation area.

Roche Diagnostics

User Manual · 4.4 15

cobas IT 1000 application

Bookmarking favorite help topics

You can bookmark your favorite help topics by saving them in the Navigation area of

the Help application, or in the favorites folder of your browser.

P To save favorite help topics in the Help window

1

Open the Help on the page you wish to save as a favorite.

2

Choose the Favorites tab.

The current topic title is displayed in the text box of the Favorites tab.

3

Click Add.

The page is added to the list of favorites.

S

P To delete favorite help topics

1

Select the topic you wish to delete, and then click Remove.

S

P To save favorite help topics in your browser

1

Open the Help page you wish to save in your favorites

2

In the Global area, click Bookmark.

The Add a favorites dialog of your browser opens.

3

Choose the folder in which you wish to save the bookmark, and then click Add.

The bookmark is saved in the favorites of your browser.

S

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.

cobas IT 1000 application

Roche Diagnostics

16 User Manual · 4.4

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.

System safety information

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

data corruption, and data losses.

CAUTION

Incorrect operation or the use of wrong components

The data in the system can be incorrect or corrupt.

r Use only computers, monitors, printers, and accessories recommended by the

manufacturer.

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

antivirus software; check the event log for system error entries).

CAUTION

Corrupt data due to viruses

The data in the system can get corrupted due to viruses.

r Install a firewall, maintain up to date antivirus software, and keep your operating

system up to date.

CAUTION

Incorrect or corrupt data due to unauthorized access

Data security is breached if unauthorized users have access to your user ID and password.

r Always enter your password unobserved.

r Do not write down your password.

r Never write down the password in a contact form, in the address book, or in a file on

the computer.

r Do not disclose your password to anyone.

r Roche will never ask you for your password.

r If you ever disclose your password to anyone, change it immediately after.

r If you think anyone else might have access to your account, then contact your local

Roche affiliate.

Roche Diagnostics

User Manual · 4.4 17

cobas IT 1000 application

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:

r Allow connection of authorized external devices only.

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

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

equipment.

r 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.

r If additional software is required on the server, contact your Roche Service

representative to ensure validation of the software in question.

r 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.

r 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.

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

accessed by authorized persons only.

CAUTION

Sensitive data - data tampering in transmission

Unprotected WIFI connections between instruments and cobas IT 1000 application may

be used to gain unauthorized access to data and for data tampering.

Roche recommends the following precaution:

r Use EAP security for WIFI connections.

CAUTION

Data loss

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

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.

cobas IT 1000 application

Roche Diagnostics

18 User Manual · 4.4

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.

Understanding

cobas IT 1000 application

1 Software Overview........................................................................................................................... 21

2 User Interface ................................................................................................................................... 31

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Roche cobas IT 1000 User manual

Roche cobas IT 1000 User manual

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