Roche cobas c 111 User manual

cobas c111 system

Printer Tool Operator’s Manual

Version 1.2

cobas c111

Roche Diagnostics

2 Printer Tool Operator’s Manual · Version 1.2

Document information

Revision history

Edition notice This document is for users of the cobas c111 Printer Tool. Every effort has been

made to ensure that all the information contained in this document is correct at the

time of printing. However, Roche Diagnostics International Ltd reserves the right to

make any changes necessary without notice as part of ongoing product development.

Intended use The cobas c111 Printer Tool is intended for printing sample, QC, and QC History

results that were generated on a cobas c111 instrument. The tool runs

independently on an external computer.

The cobas c111 instrument is a continuous random-access analyzer intended for in

vitro determination of clinical chemistry and electrolyte parameters in serum,

plasma, urine or whole blood (HbA1c).

Trademarks The following trademarks are acknowledged: COBAS, COBAS C, and LIFE NEEDS

ANSWERS are trademarks of Roche.

All other trademarks are the property of their respective owners.

Instrument approvals The cobas c111 instrument meets the protection requirements laid down in IVD

Directive 98/79/EC.

Regulatory compliance is demonstrated by the following labels:

Manual version Software version Revision date Changes

1.0 1.0 February 2009 First publication.

1.1 1.0 December 2012 Address change.

1.2 1.0 October 2015 Operating system references

updated.

For in vitro diagnostics use.

Complies with the IVD directive 98/79/EC.

CUS

®

Issued by Underwriters Laboratories, Inc. (UL) for Canada and the

US.

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cobas c111

Contact address

Manufacturer

Distributor

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Switzerland

Roche Diagnostics

9115 Hague Road

Indianapolis, Indiana

USA

cobas c111

Roche Diagnostics

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Table of contents

Document information 2

Contact address 3

Preface 7

How to use this manual 7

Where to find information 7

Online Help system 8

Conventions used in this manual 9

System Description Part A

1Safety

Legal liability A–5

Safety classification A–5

Data security A–5

Data integrity A–5

2 Requirements

Hardware and software requirements A–9

Functional test A–10

Operator qualifications A–10

3 Installation

Introduction A–13

Overview of installation procedures A–14

Performing the installation A–16

4 Introduction

Overview A–27

Preconditions A–29

Using the software A–29

5 Software description

Main screen A–37

Status area A–38

Global action buttons area A–38

Sample Results work area A–39

QC Results work area A–43

QC History work area A–46

Configuration tabs A–51

Alarms dialog box A–80

Help screen A–81

Operation Part B

6 Generating reports

Introduction B–5

Importing results B–6

Printing sample results B–8

Printing QC results B–15

Printing QC History results B–18

7 Defining templates

Introduction B–23

Report structures B–24

Template Editor dialog box B–27

Frames B–29

Placing and changing report elements B–31

Defining templates B–38

Making templates available B–43

Backing up templates B–43

Configuration Part C

8 Configuration

Introduction C–5

System configuration C–6

Host communication C–6

Test definitions C–6

Control Data definitions C–8

Installing a new user interface or online Help language

C–9

Troubleshooting Part D

9 Troubleshooting

Reacting to messages D–5

Troubleshooting D–9

Glossary and Index Part E

Glossary E–3

Index E–5

Revision Part F

10 Revision

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Preface

The cobas c111 Printer Tool is intended for printing sample, QC, and QC History

results that were generated on a cobas c111 instrument. The tool runs

independently on an external computer.

The cobas c111 instrument is a continuous random-access analyzer intended for in

vitro determination of clinical chemistry and electrolyte parameters in serum,

plasma, urine or whole blood (HbA1c).

This document is for users of the cobas c111 Printer Tool. It contains descriptions

of its features and general operation concepts, operating techniques, configuration

possibilities, and troubleshooting procedures.

How to use this manual

To help you find information quickly, there is a table of contents at the beginning of

the manual and each chapter. In addition, the index at the back lists keywords that

lead you to the required information.

Where to find information

This document covers all information available for installing and working with the

cobas c111 Printer Tool.

The information is divided into the following chapters:

Preface The Preface provides general information on how to use this documentation.

Safety These sections provide information concerning the safe operation of the cobas c111

Printer Tool. You should familiarize yourself with this before you start working with

the cobas c111 Printer Tool.

Requirements These sections list the conditions that must be met for safe and trouble-free operation

of the cobas c111 Printer Tool.

Installation These sections describe what needs to be done to get the cobas c111 Printer Tool

running.

o Keep this Printer Tool Operator’s Manual in a safe place to ensure that it is not

damaged and remains available for use.

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

The cobas c111 Printer Tool is designed for use in conjunction with cobas c111

instruments.

For information on the configuration and operation of cobas c111 instruments, see the

cobas c111 Instrument Operator’s Manual. Use the index at the back of that manual to

find specific information.

cobas c111

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8 Printer Tool Operator’s Manual · Version 1.2

Introduction These sections give an overview of the cobas c111 Printer Tool, and they describe

some features that facilitate working with it.

Software description These sections provide detailed information on the elements of the various dialog

boxes, and point to their use.

Operation These sections describe how to generate reports.

Templates These sections describe how to define new templates for sample results reports.

Templates constitute sets of rules that define which information will be included in a

report and how it will be represented.

Configuration These sections describe how to set up the cobas c111 Printer Tool and how to install

new user interface language and online Help files.

Troubleshooting These sections describe how to handle exceptional situations, for example what to do

if the installation could not be completed successfully or how to react to messages

that were generated by the cobas c111 Printer Tool.

Glossary and Index The Glossary explains key terms used in this documentation; the Index consists of an

alphabetical list of keywords that point to the position in this documentation where

you can find information related to them.

Online Help system

The cobas c111 Printer Tool has a context-sensitive online Help to aid in its

operating. Clicking the Help button displays Help text relating to the dialog box or

tab that is currently active. The online Help information is the same as that contained

in the cobas c111 Printer Tool Operator’s Manual.

e

For information on the elements used on Help screens, see Help screen on page A-81.

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Conventions used in this manual

Visual cues are used to help locate and interpret information quickly. This section

explains the formatting conventions used in this document.

Symbols The following symbols are used:

Abbreviations The following abbreviations are used

Screen representations Screen representations shown in this documentation are for illustrative purposes

only. The screens do not necessarily show valid data.

Symbol Used for

a Start of procedure

End of procedure

o List item

e

Cross-reference

f Call-up (software reference)

Caution statement

NOTICE

Notice statement

Tip

CAUTION

Abbreviation Definition

e.g. exempli gratia – for example

EN European norm

ID Identifier

IEC International ElectrotechnicalVersion 1.2 Commission

IVD In vitro diagnostics

LIS Laboratory information system

n/a Not applicable

PDF Portable document format

STAT Short turn around time

USB Universal serial bus

UL Underwriter Laboratories Inc.

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1 Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

2 Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7

3 Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-11

4 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-25

5 Software description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-35

System Description

A

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Table of contents

Safety

The following sections provide information concerning the safe operation of the

cobas c111 Printer Tool.

Legal liability .................................................................................................................... A–5

Safety classification ......................................................................................................... A–5

Data security .................................................................................................................... A–5

Data integrity ................................................................................................................... A–5

In this chapter

Chapter

1

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Table of contents

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Legal liability

Roche Diagnostics International Ltd. assumes only limited liability when using the

cobas c111 Printer Tool in conjunction with a cobas c111 instrument. Any

attempt to change the result data renders liability nil and void.

Safety classification

Before you start using the cobas c111 Printer Tool and the cobas c111 instrument,

you must be familiar with the following symbols and their meanings:

Data security

Access control to the computer and the cobas c111 Printer Tool is the responsibility

of the customer.

Data integrity

The cobas c111 Printer Tool does not allow changing result data generated by the

cobas c111 system.

Caution

Indicates a hazardous situation which, if not avoided, may result in

minor or moderate injury.

NOTICE Notice

Indicates a hazardous situation which, if not avoided, may result in

property damage.

CAUTION

NOTICE

Malicious software and hacker attacks

The cobas c111 Printer Tool is not protected against malicious software and hacker

attacks.

The customers are responsible for IT security of their IT infrastructure and for protecting it

against malicious SW and hacker attacks.

CAUTION

Danger of incorrect result data

Do not attempt to modify the result data.

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cobas c111 2 Requirements

Table of contents

Requirements

The following sections provide information on the conditions that must be met for

safe and trouble-free operation of the cobas c111 Printer Tool.

Hardware and software requirements .......................................................................... A–9

cobas c111 Printer Tool computer ......................................................................... A–9

cobas c111 instrument ........................................................................................... A–10

Functional test ............................................................................................................... A–10

Operator qualifications ................................................................................................ A–10

In this chapter

Chapter

2

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Hardware and software requirements

To ensure smooth operation, there are some requirements both for the cobas c111

Printer Tool computer and the cobas c111 instrument that must be met.

cobas c111 Printer Tool computer

The following conditions must be met for the cobas c111 Printer Tool to work

properly:

Item Requirement

RAM At least 256 MB.

Free space on the hard disk At least 1 GB.

Screen resolution At least 800 x 600 ppi, recommended are 1024 x 768 ppi.

Anti-virus software Installed and with real-time protection enabled.

PDF reader Any software for reading PDF files.

Software for generating

digital copies (optional)

Any software that can generate digital copies of the reports,

for example Adobe PDF Writer.

(This software is required if you intend to generate digital

copies of the reports.)

Interfaces USB drive version 1.1 or higher.

Serial connection interface RS232.

RS232 null modem cable

e

For the pin mapping, see RS232 null modem cable on

page A-24.

For obtaining RS232 cables, contact your service

representative.

This cable is not required if you intend to transfer results

using a USB stick exclusively.

CD-ROM drive Available.

Operating system o Microsoft Windows XP SP 2 (32 bit)

o Windows 7 (64 bit)

o Windows 8.1 (64 bit)

o Windows 10 (64 bit)

The user of the cobas c111 Printer Tool needs user rights

for saving files on the computer and for using the CD drive.

Table A-1 Hardware and software requirements for computer

NOTICE

Malicious software and hacker attacks

The cobas c111 Printer Tool is not protected against malicious software and hacker

attacks.

The customers are responsible for IT security of their IT infrastructure and for protecting it

against malicious SW and hacker attacks.

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2 Requirements cobas c111

cobas c111 instrument

For operation of the cobas c111 Printer Tool, cobas c111 instrument software

version 2.0.1 or higher is required.

If the computer that runs the cobas c111 Printer Tool is connected to a cobas c111

instrument for data transfer, host communication must be configured both on the

cobas c111 instrument and on the cobas c111 Printer Tool.

e

For configuring host communication on the cobas c111 Printer Tool, see:

To configure the cobas c111 Printer Tool

on page A-19 and

Host tab

on page A-77.

For information on the configuration and operation of cobas c111 instruments, see

To configure the cobas c111 instrument on page A-20.

Functional test

To ensure proper functioning of the cobas c111 Printer Tool in cooperation with

the cobas c111 instrument, you need to perform a basic functional test before

working with live results.

e

To perform a basic functional test for result transfer using host communication on

page A-20.

To perform a basic functional test for result transfer with a USB stick on page A-22.

Operator qualifications

The cobas c111 Printer Tool is primarily intended for the following groups of users:

If host communication is used between the cobas c111 Printer Tool computer and the

cobas c111 instrument, the latter cannot be connected to a LIS.

Operator Level of expertise

Lab technicians Good knowledge of operating the cobas c111 instrument.

Lab manager Manages all systems in the laboratory.

Administrative assistant Is responsible for administrative tasks in the laboratory. Has

only limited knowledge of laboratory tasks and procedures.

IT support person Maintains the computer and network infrastructure in the

laboratory.

Table A-2 Operator levels

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Roche cobas c 111 User manual

Roche cobas c 111 User manual

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