Roche cobas Operator’s Manual

cobas® e-library

Operator’s Manual Software Version 2.4.0

Document information

cobas® e-library

Revision history

Manual Version Software Version Revision date Changes

1.0 1.1.2 01-MAR-2007

2.0 1.2.0.6 01-DEC-2008 Comment function and search by comment added.

3.0 2.2.0 05-JUN-2009 Added: automatic pre-selection mode; update by Internet option.

3.1 2.3.0 19-JUN-2012 Aligned content with functionality and appearance of HRD viewer

2.3.0 and UI strings 1.0

3.2 2.4.0 07-FEB-2013 Updated screens and text for new version.

3.3 2.4.0 01-DEC-2015 Corrected Document information and Abbreviations sections.

3.4 2.4.0 01-MAR-2017 Added information about not using the Automatic mode of pre-selection. Updated intended use.

Table 1 Revision history

Language Order Number

International 0499 0269 001

Edition notice cobas® e-library Operator’s Manual.

This manual is for operators of the cobas® e-library.

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 Ltd. reserves the right to make any changes necessary without notice as part of ongoing product development.

Any customer modification will render the warranty or service agreement null and void.

Software updates are done by Roche Service representatives.

Intended use The cobas® e-library application is an electronic repository of instructions for use,

lot-specific values, and instrument settings. It is important that the operator reads this manual thoroughly before using the application.

Trademarks COBAS, COBAS C, COBAS E, ELECSYS, and LIFE NEEDS ANSWERS are

trademarks of Roche.

All other trademarks are the property of their respective owners.

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cobas® e-library

Contact addresses

Manufacturer

Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim Germany

Made in Switzerland

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cobas® e-library

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cobas® e-library

Document information 2 Table of contents 5 Preface 7

Description

1 Description

Safety information 13

cobas link platform 15 cobas link PC 16

Software description

2 Software description

Application overview 23 New Entries screen 25 Search screen 30 Preferences screen 32 Lot Preferences screen 36 Update e-library screen 37 Log Off screen 38

Operation

3 Operation

Using cobas e-library 43 How to 48

Glossary

4 Glossary

Index

Index 59

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cobas® e-library

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cobas® e-library

Preface

The cobas e-library application, which runs on the cobas link platform, gives laboratory personnel access to announcements, lot-specific values, instrument settings, and other information about the analyzers they use.

This Operator’s Manual is intended for operators of cobas e-library. It contains detailed descriptions of cobas e-library features and general operational concepts available to operators.

This manual does not contain service procedures or detailed information about the cobas link PC.

Where to find information

o Keep this manual in a safe place to ensure that it is not damaged and remains available

o This Operator’s Manual should be easily accessible at all times.

for use.

To help you find information quickly, there is a table of contents at the beginning of the manual and each part. This manual contains the following parts:

o Part 1 - Description provides an overview of the cobas e-library application as

well as safety information.

o Part 2 - Software description describes the application screens. o Part 3 - Operation describes common operational tasks. o Part 4 - Glossary provides definitions of terms used in this manual. o Part 5 - Index.

Online Help system

cobas e-library has a context sensitive online Help feature to aid you in using the application. "Context sensitive" means that wherever you are located within the e-library application, choosing the Help feature displays help text relating to that area of the software. The Online Help offers a quick and convenient way to find information, such as explanations of screens and dialog boxes and how to perform particular procedures.

To view the online Help, click the Help link button in the bottom left corner of each screen.

Conventions used in this manual

Visual cues are used to help locate and interpret information in this manual quickly. This section explains formatting conventions used in this manual.

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Symbols The following symbols are used:

Symbol Used for

o List items

h Call-up (software reference)

Abbreviations The following abbreviations are used:

Abbreviation Definition

ANSI American National Standards Institute

BTS Barcode Transfer Sheet

PC Personal Computer

cobas® e-library

Start of procedure

End of procedure

Cross-reference

Tips

Safety alert

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Description

1 Description ....................................................................................................................................... 11

cobas® e-library 1 Description

Table of contents

Description 1

This part describes the safety classifications and also lists the safety texts found throughout the rest of the manual. In addition it provides an overview of the cobas link platform and the personal computer (PC) on which it operates.

In this chapter

Safety information................................................................................................................13

Safety classifications.......................................................................................................13

Safety precautions ..........................................................................................................13

cobas link platform...............................................................................................................15

cobas link PC ........................................................................................................................16

Chapter

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1 Description cobas® e-library

Table of contents

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cobas® e-library 1 Description

Safety information

Before operating the cobas e-library, it is essential that the operator reads and understands the warnings, cautions, and safety requirements listed here. This section describes the safety classifications and also lists the safety texts found throughout the rest of the manual

Safety classifications

The safety precautions and important operator notes are classified according to ANSI Z535 standards. Familiarize yourself with the following meanings and icons:

Caution

The safety alert symbol by itself without a signal word is used to promote awareness to hazards which are generic or to direct the reader to safety information provided elsewhere in the document.

These symbols and signal words are used for specific hazards:

WARNING

CAUTION

NOTICE

Safety precautions

Warning

r Indicates a hazardous situation which, if not avoided, could result in death or serious

injury.

Caution

r Indicates a hazardous situation which, if not avoided, could result in minor or moderate

injury.

Notice

Indicates a hazardous situation which, if not avoided, could result in damage to equipment.

Important information which is not safety relevant is indicated by the following symbol:

Indicates additional information on correct use of the analyzer or useful tips.

Particular attention must be taken of the following safety precautions. If these safety precautions are ignored, the operator may suffer serious or fatal injury. Each precaution is important.

This Operator’s Manual should be easily accessible at all times.

Operator qualification Operation should be conducted by personnel who have undergone training by Roche

Diagnostics. Before operating this application, operators are required to have detailed knowledge of relevant guidelines and norms as well as the information and procedures contained in the Operator’s Manual.

Carefully follow the procedures specified in the Operator’s Manual for the operation of the application.

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1 Description cobas® e-library

Safety information

Installation requirements

r Installation is performed by a Roche service representative. The customer is

CAUTION

responsible for providing the necessary facilities.

Replacement of hardware

r If, for any reason, an item of hardware is faulty (for example, a hard disk or interface

CAUTION

card), contact your Roche service representative. Do not attempt to repair faulty

hardware or replace hardware items without confirmation from your Roche service

representative.

NOTICE

Operating system and updates

cobas link operates in a Windows™ XP environment. If the operating system is to be

updated or cobas link updates or extensions are to be installed, this will be done by Roche service representatives. Any attempts to modify the operating system or the cobas link installation may lead to a loss of data.

Third-party software

If any third-party software products are installed on the cobas link computer, this may result in incorrect behavior of the application. The installation and use on the cobas link computer of any third-party software that is not approved by Roche is not permitted.

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cobas® e-library 1 Description

cobas link platform

The cobas link platform is the gateway for retrieving and distributing information from the Roche Remote Service infrastructure to cobas analyzers in the laboratory (Figure 1-1 cobas link platform (p. 15)). Information such as instructions for use, value sheets, important notes, as well as test-specific and lot-specific analyzer settings are made available through cobas link.

cobas link is an integral and mandatory part of the cobas modular platform analyzers.

A Remote Service infrastructure C cobas link data station

B cobas analyzers

Figure 1-1 cobas link platform

A number of applications and other information, for example about controls and calibrators, are available on the cobas link, which automates manual tasks, improving efficiency and reducing errors.

No patient names or patient IDs are transferred to or stored within the Remote Service

infrastructure.

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1 Description cobas® e-library

cobas link PC

cobas link and its applications run on a personal computer (PC) with a number of peripheral components (Figure 1-2 cobas link PC components (p. 16)).

u For more information about the PC and its components, consult the documentation

supplied by the manufacturer.

A Monitor G PC power switch

B Monitor power switch H Printer

C Personal Computer (PC) I Printer power switch

D DVD RW drive J Switch (switchable hub used to connect

multiple analyzers to cobas link)

E Floppy disk drive K Keyboard and mouse

F USB ports (for data export)

Figure 1-2 cobas link PC components

The components of the cobas link PC might differ between different PC editions. For

example, the floppy disk drive is not present in all editions.

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cobas® e-library 1 Description

cobas link PC

A Personal Computer (PC) F Power cord

B Analog phone port G Keyboard

C Ethernet connection to the network H Mouse

D Ethernet connection to a cobas analyzer I Video (monitor)

E USB ports (printer)

Figure 1-3 cobas link PC (rear view)

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1 Description cobas® e-library

cobas link PC

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Software description

2 Software description......................................................................................................................... 21

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