Roche cobas IT 1000 User manual

cobas IT 1000 application

Instructions for Use

Roche Diagnostics

2 Instructions for Use · 1.3

2 cobas IT 1000 application

Roche Diagnostics

Instructions for Use · 1.3 3

cobas IT 1000 application

Revision history

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,

Instructions for Use version 1.3.

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 patient test results and quality control results (electronically or by

manual entry).

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 certification.

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

o Assessment of patient and quality control results according to 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.

Manual version Software version Revision dates Main change

1.0 2.0 September 2011 Software update/ New

manual for US launch.

1.1 US 2.00.01 April 2012 Software and manual

updates

1.2 US 2.01.00 March 2013 Software and manual

updates

1.3 US 2.02.00 November 2013 Software and manual

updates

Table 1 Revision history

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4 Instructions for Use · 1.3

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.

Trademarks Recognized trademarks:

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

CARDIAC, COBAS B, COBAS, COAGUCHECK 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 patient test results, 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., expiry date)

Adaptation of the configuration of the application

Configuration of connected instruments

Typical role: User

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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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

US Distribution

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

cobas IT 1000 application

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6 Instructions for Use · 1.3

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Instructions for Use · 1.3 7

cobas IT 1000 application

Table of contents

Revision history 3

Contact addresses 5

Table of contents 7

Using this manual 9

This document 9

Online help 10

Safety classifications 13

System safety information 14

Maintenance 15

Laboratory workflows 16

Third-party software 16

Understanding cobas IT 1000

1 Software Overview

System requirements 21

Browser settings 22

Security concept 23

Initial steps 24

2 User Interface

Application screen overview 31

Software basics 37

Using cobas IT 1000 application

3 My Settings

Language 43

Warnings Configuration 45

Personalizations 49

4 System

General Settings 55

Demographic Definition 80

Demographic Assignment 82

Patient Demographic Assignment 84

Instrument Alarm Definition 86

Instrument Alarm Assignment 94

System Alarm Assignment 96

Comment Definition 98

Sample Type Definition 100

Tube Definition 102

Test Definition 104

Test Group Definition 110

Message Broker Monitor 116

5 Organization

Organization module components 121

6 Material

Material Definition 171

Lot Management 174

7 Instruments

Status 185

Maintenance 191

Configuration 195

Instrument Assignment 205

Maintenance Definition 214

Comment Assignment 217

Off-Line Instruments 220

8 Quality Control

Quality Control module 225

9 Results & Patients

Results & Patients module 251

10 Reports

Report Generation 283

Report Log 286

Types of Reports 288

Appendix

11 Glossary

Index

Index 325

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cobas IT 1000 application

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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

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10 Instructions for Use · 1.3

The document consists of two main parts and an appendix.

o Understanding cobas IT 1000 (p. 17).

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. 39).

Instructions on using the various software modules.

o Glossary (p. 319).

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 (Instructions for Use).

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. 31).

S

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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

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12 Instructions for Use · 1.3

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.

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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 Z535.6-2006. 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.

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.

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14 Instructions for Use · 1.3

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.

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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

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 uninterruptable power supply.

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16 Instructions for Use · 1.3

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

1 Software Overview........................................................................................................................... 19

2 User Interface ................................................................................................................................... 29

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Instructions for Use · 1.3 19

cobas IT 1000 application 1 Software Overview

Table of contents

Software Overview 1

This chapter is an overview cobas IT 1000 application 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,_,-

In this chapter

Chapter

1

System requirements............................................................................................................21

Browser settings....................................................................................................................22

Enabling application pop-ups.......................................................................................22

Security concept ...................................................................................................................23

Initial steps ............................................................................................................................24

Logging in .......................................................................................................................24

Changing the user password.........................................................................................25

Predefined Configurations ...........................................................................................26

Warning Messages..........................................................................................................26

Error Messages ...............................................................................................................26

Information Messages....................................................................................................27

Confirmation Messages.................................................................................................27

Module descriptions ......................................................................................................27

Business rules..................................................................................................................28

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1 Software Overview cobas IT 1000 application

Table of contents

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