Roche cobas IT 1000 User manual

cobas IT 1000 application

User Manual

Version 4.6

Software version 2.06.00

cobas IT 1000 application

Roche Diagnostics

2 User Manual · Version 4.6

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 4.6 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 Dashboard support: Live view (Production statistics) Statistics generated by cobas

IT 1000 application can be extracted and displayed on monitors, wallboards and

mobile devices (accessible only within the intranet).

o Support for cobas infinity POC mobile, 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

(1)

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

Manual version Software version Revision dates Main change

Table 1 Revision history

cobas IT 1000 application

Roche Diagnostics

4 User Manual · Version 4.6

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.

Training Do not carry out operation tasks or maintenance actions unless you have received

training from Roche Diagnostics. Leave tasks that are not described in the user

documentation to trained Roche Service representatives.

Screenshots The screenshots in this publication have been added exclusively for the purpose of

illustration. Configurable and variable data such as patient demographics,

parameters, results, path names etc. visible therein is fictitious and must not be used

for laboratory purposes.

User group Description of use

(1)

(1) include potential system interfaces

Nurses/Nurse Educator Manual entry of quality control results

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

Retrospective assessment of results to support compliance with the

customer’s quality environment

View information generated by cobas IT 1000 application on

cobas infinity POC mobile

POC Coordinator Retrospective assessment of results to support compliance with the

customer’s quality environment

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

Adaptation of the configuration of cobas IT 1000 application

Configuration of connected instruments

View information generated by cobas IT 1000 application on Live

View Dashboard

View information generated by cobas IT 1000 application on

cobas infinity POC mobile

IT Manager WLAN device configuration security type EAP

EAP Settings management (EAP settings and EAP settings

assignment).

WLAN device configuration security type EAP

Table 2 Users

User role Description of use

User Person who physically interacts with the software and/or the

instrument.

A user is assigned to one or several locations.

User profile: Operator The user profile “Operator” is used for individuals who do not

have access to the application but who physically interact with the

instrument.

An operator is assigned to one or several locations.

An operator is required to be certified for each of the instrument

types used.

Table 3 User roles

Roche Diagnostics

User Manual · Version 4.6 5

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.

Limited warranty and limitation

of liability for software

The software described in this User Manual (the “Software”) is provided “as is”

without warranty of any kind, either express or implied, including, but not limited to

the implied warranties of merchantability or fitness for a particular purpose. ROCHE

SPECIFICALLY DISCLAIMS ALL WARRANTIES TO THE FULLEST EXTENT

PERMITTED BY LAW. The entire risk as to the quality and performance of the

Software is with Customer should the Software prove to be defective. Customer

assumes the entire costs of all necessary servicing, repair or correction of the

Software. However, Roche warrants that the program media on which the Software is

furnished is and will remain free from defects in materials and workmanship under

normal use for a period of ninety (90) days from the date of delivery.If the Software

application program media is found defective, Roche’s sole obligation under this

warranty is to remedy such defect in a manner consistent with Roche’s regular

business practices. In the event that Roche is unable to remedy such defect within a

reasonable amount of time, Roche may terminate the license for the Software granted

in the User Manual by written notice to Customer, in which event Customer shall be

entitled to a refund of the unamortized portion of any applicable license fee actually

paid by Customer to Roche for the Software. In such an event, Customer must return

the defective program media to Customer as a condition to receipt of Customer’s

refund. The foregoing obligations to remedy defects and to refund license fees do not

apply if the Software has been altered by Customer or has not been installed,

operated, repaired or maintained in accordance with any written instructions

provided by Roche. Any service provided by Roche to remedy problems due to

Customer’s errors or system and network inadequacies shall be billed at Roche’s

standard time and material charges.IN NO EVENT WILL ROCHE OR ANY OF

ROCHE’S AFFILIATES (OR THEIR RESPECTIVE OFFICERS, EMPLOYEES,

CONSULTANTS, ATTORNEYS OR AGENTS) BE LIABLE FOR ANY SPECIAL,

INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING

BUT NOT LIMITED TO DAMAGE TO COMPUTER SOFTWARE OR

HARDWARE (WHETHER OR NOT PROVIDED BY ROCHE), LOST PROFITS,

LOST DATA OR INFORMATION, LOSS OF USE OF THE SOFTWARE,

BUSINESS INTERRUPTION, LOSS OF BUSINESS REPUTATION OR

GOODWILL, DOWNTIME COSTS, OR ANY OTHER COMMERCIAL DAMAGES

OR LOSSES WHICH CUSTOMER MAY INCUR OR EXPERIENCE, DIRECTLY

OR INDIRECTLY, ARISING OUT OF OR RELATING TO THE SOFTWARE,

HOWEVER CAUSED AND REGARDLESS OF THE THEORY OF LIABILITY,

EVEN IF ROCHE OR ANY OF ITS AFFILIATES HAD BEEN ADVISED OF THE

POSSIBILITY OF SUCH DAMAGES. ROCHE’S TOTAL LIABILITY FOR ALL

DAMAGES ARISING OUT OF OR RELATING TO THE USE OF THE

SOFTWARE BY CUSTOMER SHALL BE LIMITED, AT ROCHE’S OPTION, TO

REPLACEMENT OF THE SOFTWARE OR A REFUND BY ROCHE OF ANY

LICENSE FEES RECEIVED FROM CUSTOMER WITH RESPECT TO THE

SOFTWARE.

cobas IT 1000 application

Roche Diagnostics

6 User Manual · Version 4.6

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. 144).

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. 249), EAP Settings (p. 254), and EAP Settings

Assignment (p. 263).

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. 351).

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 4.6 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. 404) and User Statistics (p. 415).

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

added.

u For details, see User Certification History (p. 414).

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. 23).

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. 49)

u Defining warnings for other users (p. 156).

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. 70)

New patient alarms Two new patient alarms were added:

o PD: Patient discharged

o PN: Patient not admitted

u Patient alarms (system alarms) (p. 99).

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. 162)

u Certification concept (p. 171)

u User Certifications (p. 189).

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. 162).

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. 165)

u Certification details (p. 172).

cobas IT 1000 application

Roche Diagnostics

8 User Manual · Version 4.6

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. 217).

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. 231).

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. 317).

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. 412).

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. 27).

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

u Filtering (p. 38).

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

u Correcting failed imports of exam results (p. 167).

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

u Printing Levey-Jennings charts (p. 300).

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

u (p. 365).

Roche Diagnostics

User Manual · Version 4.6 9

cobas IT 1000 application

Table of contents

Revision history 2

Contact addresses 6

What is new in version 4.4 6

What is new in publication version 4.5 7

What is new in publication version 4.6 8

Table of contents 9

Conventions used in 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 25

Security concept 26

Initial steps 27

2 User Interface

Application screen overview 35

Software basics 41

Using cobas IT 1000 application

3 My Settings

Language 47

Warnings Configuration 49

Personalizations 54

4 System

General Settings 61

Demographic Definition 87

Demographic Assignment 89

Patient Demographic Assignment 91

Instrument Alarm Definition 93

Instrument Alarm Assignment 103

System Alarm Assignment 105

Comment Definition 107

Sample Type Definition 109

Tube Definition 111

Test Definition 113

Test Group Definition 120

Message Broker Monitor 125

5 Organization

Organization module components 129

Sites 130

Locations 135

HIS Locations 140

Workgroup Definition 142

User Profiles 144

User Management 152

Certification Tasks 162

Certification 169

Competencies 193

Notification Templates 195

HIS Location Import 199

User Import 201

6 Materials

Material Definition 207

Lot Management 210

7 Instruments

Status 231

Maintenance 238

Configuration 242

EAP Settings 254

EAP Settings Assignment 263

Instrument Assignment 266

Maintenance Definition 275

Comment Assignment 278

Off-Line Instruments 281

8 Quality Control

Quality Control module 285

Result Management 287

Levey-Jennings Chart 293

Cumulative Chart 296

Levey-Jennings Review 298

Levey-Jennings Review by Lot 301

Linearity Review 302

Multirules 305

Manual Result Entry 308

QC Test Mapping 310

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10 User Manual · Version 4.6

cobas IT 1000 application

9 Quality Control (RiliBÄK)

Quality Control (RiliBÄK) module 315

Result Management 317

Levey-Jennings Chart 324

Cumulative Chart 326

Levey-Jennings Review 328

Manual Result Entry 331

RiliBÄK Test Assignment 333

Result Alarm Monitor 336

QC Test Mapping 340

RMSE Alarm Monitor 343

Effective QC Range Review 347

10 Results & Patients

Results & Patients module 353

Sample Validation 354

Patient Query 356

Single Patient Edit 361

Result Validation 365

Result Query 376

11 Reports

Report Generation 381

Report Log 384

Types of Reports 386

Appendix

12 Formats for exam results input files

Configurable formats 421

13 Glossary

Index

Index 429

Roche Diagnostics

User Manual · Version 4.6 11

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. 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. 43).

Instructions on using the various software modules.

o Glossary (p. 423).

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

Roche Diagnostics

12 User Manual · Version 4.6

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. 35)

s

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

Roche Diagnostics

User Manual · Version 4.6 13

cobas IT 1000 application

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 · Version 4.6

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 · Version 4.6 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 · Version 4.6

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 · Version 4.6 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 · Version 4.6

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 ................................................................................................................................... 33

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