Roche cobas c 111 User manual

cobas c111 system

Development Channel Operator’s Manual

Version 1.1

Roche Diagnostics

Development Channel Operator’s Manual · Version 1.1 3

cobas c111

Table of contents

Document information ........................................................................................................5

Where to find information ..................................................................................................7

Conventions used in this manual .......................................................................................8

Safety .......................................................................................................................................9

Legal liability ....................................................................................................................9

Safety classification .........................................................................................................9

Overview ...............................................................................................................................10

Defining development channel applications ............................................................10

Changing existing development channel applications ............................................11

Installing development channel applications on the cobas c111 instrument ...12

Requirements .......................................................................................................................13

Operator qualification ..................................................................................................13

Hardware external computer ......................................................................................13

Software external computer .........................................................................................13

cobas c111 instrument ..............................................................................................14

Items that concern both systems ................................................................................14

Available information ..................................................................................................14

Operation .............................................................................................................................15

Setting up the Development Channel Programming Software ..............................15

Defining development channel applications ............................................................17

Changing development channel applications ...........................................................21

Printing barcodes ..........................................................................................................23

Deleting development channel applications .............................................................25

Installing and configuring development channel applications on the

cobas c111 instrument ..............................................................................................25

Checks for existing applications (reagents not on board) ................................27

Checks for existing applications (reagents on board) .......................................30

Preparing the development channel reagent sets .....................................................32

Filling development channel reagent bottles ......................................................33

Interpreting raw data ....................................................................................................34

Exporting results .....................................................................................................34

Importing results to a spreadsheet tool ...............................................................35

Interpreting result data ..........................................................................................35

Software description ...........................................................................................................39

Main screen ....................................................................................................................39

Online Help ...................................................................................................................42

Key measurement parameters of the cobasc111 instrument ..............................43

General ...........................................................................................................................45

Diluent ............................................................................................................................46

Calibration .....................................................................................................................48

Dilution of Standard Series ...................................................................................50

Control Parameters .......................................................................................................52

Pipetting .........................................................................................................................53

Sample and Control Definitions ...........................................................................53

Pipetting Volumes ..................................................................................................54

Calculation .....................................................................................................................55

General .....................................................................................................................55

Units .........................................................................................................................57

Calibration ...............................................................................................................58

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4 Development Channel Operator’s Manual · Version 1.1

cobas c111

Checks ............................................................................................................................60

Endpoint ..................................................................................................................60

Kinetic ......................................................................................................................61

High/Low Activity ..................................................................................................62

Test Range ................................................................................................................64

Lin Reg Curve Range ..............................................................................................65

Replicate Deviation ................................................................................................67

Antigen Excess ........................................................................................................69

Result Evaluation ..........................................................................................................72

Reagent Data ..................................................................................................................73

Pre-Diluent Data ...........................................................................................................74

Special Diluent Data .....................................................................................................75

Glossary ................................................................................................................................76

Roche Diagnostics

Development Channel Operator’s Manual · Version 1.1 5

cobas c111 Document information

Document information

Revision history

Edition notice This document is for users who intend to install development channels on

cobas c111 instruments. 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 Development Channel Programming Software is intended for defining

applications that are used on cobas c111 instruments. It runs independently on an

external computer.

The cobasc111 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 and the European Standard EN 591. Furthermore, our

instruments are manufactured and tested according to the following international

standards:

o EN/IEC 61010-1 2

nd

Edition

o EN/IEC 61010-2-101 1

st

Edition

This documentation meets the European Standard EN 591.

Regulatory compliance is demonstrated by the following labels:

Manual version Software version Revision date Changes

1.0 1.0 February 2008 First release.

1.1 1.0 December 2012 Address changed

Complies with European Union (EU) Directive 98/79/EC.

CUS

®

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

US.

Roche Diagnostics

6 Development Channel Operator’s Manual · Version 1.1

Document information cobas c111

Contact addresses

Manufacturer

Distributed by

Roche Diagnostics GmbH

Sandhofer Strasse 116

68305 Mannheim

Germany

Made in Switzerland

Roche Diagnostics

9115 Hague Road

Indianapolis, Indiana

USA

Roche Diagnostics

Development Channel Operator’s Manual · Version 1.1 7

cobas c111 Where to find information

Where to find information

This document covers all information available for development channel

applications. No detailed information on this topic can be found in the cobas c111

Instrument Operator’s Manual

or online Help.

In addition to the information contained in this document, for each input field,

information on the possible values is given in the Input Advice area of the

Development Channel Programming Software window.

Online Help system

The Development Channel Programming Software has a context-sensitive online

Help to aid in its operating. Choosing the Help button displays Help text relating to

the section that is currently active in the Definitions area. The online Help

information is identical to the information contained in the Development Channel

Programming Software Operator’s Manual.

e

For information on the elements used on Development Channel Programming Software

screens, see Main screen on page 39.

For information on the elements used on Help screens, see Online Help on page 42.

The Development Channel Programming Software is designed for defining applications for

use on 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 the manual to find

specific information.

Roche Diagnostics

8 Development Channel Operator’s Manual · Version 1.1

Conventions used in this manual cobas c111

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 Procedural step

e

Cross-reference

Warning statement

Caution statement

NOTICE

Notice statement

Tip

WARNING

CAUTION

Abbreviation Definition

Abs. Absorbance

BC Barcode

BTS Barcode transfer sheet

DCPS Development channel programming software

DL Diluent

ID Identification

ISE Ion selective electrode

QC Quality control

R1, R2 Reagent 1, Reagent 2

S Sample

SR Start reagent

Roche Diagnostics

Development Channel Operator’s Manual · Version 1.1 9

cobas c111 Safety

Legal liability

Safety

This chapter contains information concerning the safe operation of the Development

Channel Programming Software and the use of development channel applications.

Legal liability

Roche Diagnostics Ltd. assumes only limited liability when using the cobas c111

instrument in conjunction with the cobasc111 Development Channel

Programming Software.

For detailed information on this matter refer to the latest version of the Development

Channel Registration Form cobas c 111.

Safety classification

Before you start using the Development Channel Programming Software and the

cobas c111 instrument, you must be fully familiar with the following symbols and

their meanings:

Warning

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

death or serious injury.

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.

WARNING

CAUTION

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10 Development Channel Operator’s Manual · Version 1.1

Overview cobas c111

Defining development channel applications

Overview

The Development Channel Programming Software provides the possibility to exploit

the unique analytical features of cobas c111 instruments in accordance with the

integration of chemistries not available from Roche. Such chemistries might have to

be run on other costly and infrequently used systems. The Development Channel

Programming Software is specifically designed for defining applications for use on

cobas c111 instruments, where each of these applications is identified by its own

ID.

You can obtain a license to actively use one, three or five non Roche applications on

your cobas c111 instrument. On the Development Channel Programming Software

you can define up to 80 applications.

Preconditions for working with

development channel

applications on cobas c111

instruments

o The start-up kit is available and the Development Channel Programming

Software is installed on the external computer.

o The Crypto Module for enabling the use of development channel applications is

installed on the cobas c111 instrument.

(The Crypto Module will be installed on the cobas c111 instrument by a service

representative.)

Defining development channel applications

Defining a development channel application using the Development Channel

Programming Software involves the following steps:

1. Create a new application.

You can do this in two ways:

o Create a new application from a template.

o Create a copy of an existing application and change it.

2. Define the parameters.

The system automatically performs consistency and plausibility checks when you

define values.

3. Save the definitions.

4. Print the barcode.

You can separately print an application barcode ( BTS) and a bottle barcode

( Bottle BC). All required parameters must be consistently defined before you

can print barcodes.

5. Stick the bottle barcode on the bottles.

6. Quit the Development Channel Programming Software.

e

For details on performing tasks on the cobas c111 instrument, see the cobas c111

Instrument Operator’s Manual.

For details on defining development channel applications, see Defining development

channel applications on page 17.

o Quitting the Development Channel Programming Software or opening another

development channel application automatically saves the data of the currently open

application.

o When defining application codes and short names, make sure they are unique, both

within the Development Channel Programming Software and on the cobas c111

instrument.

Roche Diagnostics

Development Channel Operator’s Manual · Version 1.1 11

cobas c111 Overview

Changing existing development channel applications

You can change parameters of an existing development channel application any time

using the Development Channel Programming Software.

Making changes to an existing application involves the following steps:

1. Decide whether you need to be able to trace the changes.

2. Do one of the following:

3. Make the changes.

If you intend to use the current (changed) application on the cobas c111

instrument, you should change the application version as well.

4. Save the changes.

5. Print the barcodes.

6. Install the application on the cobas c111 instrument.

7. Calibrate the reagents on the cobas c111 instrument.

e

For details on changing a development channel application, see Changing development

channel applications on page 21.

For details on performing tasks on the cobasc111 instrument, see Installing development

channel applications on the cobas c111 instrument on page 12 and the cobas c111

Instrument Operator’s Manual.

Modifying an existing development channel application calls for renewed installation of the

application on the cobas c111 instrument. If the new application requires different

reagents, these need to be installed. You also need to calibrate or recalibrate all reagents

that are used by this application.

If … Do this …

You want to be able to trace

the changes:

Create a copy of the application. (The copy will

automatically be opened.)

You do not want to be able

to trace the changes:

Open the application.

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12 Development Channel Operator’s Manual · Version 1.1

Overview cobas c111

Installing development channel applications on the cobas c111 instrument

Installing a development channel application on the cobas c111 instrument

involves the following steps:

1. Import the development channel application by reading its application barcode

from the barcode transfer sheet.

e

See the information on importing applications in the cobas c111 Instrument

Operator’s Manual.

2. Install the application.

e

See the information on importing applications in the cobas c111 Instrument

Operator’s Manual.

3. Prepare the application.

e

See the information on preparing applications in the cobasc111 Instrument

Operator’s Manual.

4. Read the bottle barcodes and place the reagents on the cobasc111 instrument.

e

See the information on reagent handling in the cobas c111 Instrument Operator’s

Manual.

5. Perform calibrations and QC measurements as required.

e

See the information on performing calibration and QC in the cobas c111 Instrument

Operator’s Manual.

Roche Diagnostics

Development Channel Operator’s Manual · Version 1.1 13

cobas c111 Requirements

Operator qualification

Requirements

The following sections list the conditions that must be met before you can start

defining development channel applications.

Operator qualification

Hardware external computer

Software external computer

CAUTION

Incorrect results due to inappropriate application definitions or damage to the

analyzer due to wrong operation

Operators are required to have a profound knowledge of the methodologies and

chemistries involved in defining applications, as well as the relevant guidelines and norms.

They also need good knowledge of the information and procedures contained both in the

cobas c111 Development Channel Operator’s Manual and the cobas c111 Instrument

Operator’s Manual.

Carefully follow the procedures specified in the cobas c111 Development Channel

Operator’s Manual when defining development channel applications.

Follow standard laboratory practices, especially when working with biohazard material.

Item Precondition

RAM 256 MB

Free space on harddisk 20 MB

Screen resolution 800 x 600 or higher

USB drive (optional) 1

CD-ROM drive 1

Printer Minimal resolution: 300 dpi.

Connected.

Because printouts by ink jet printers can get smeared in damp

conditions and so impede correct reading of the barcodes,

Roche recommends using a laser printer.

Table 1 Hardware requirements for the external computer

Item Precondition

Operating system Microsoft Windows XP, Service pack 2.

The user of the Development Channel Programming

Software needs user rights for saving files on the computer

and for using the CD drive.

Spreadsheet application

(optional)

The program must be able to process csv files.

Table 2 Software requirements for the external computer

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14 Development Channel Operator’s Manual · Version 1.1

Requirements cobas c111

cobas c111 instrument

Items that concern both systems

Available information

Item Precondition

System software version cobas c111 system software version 2.0 or higher is installed.

Crypto module A service representative has installed a crypto module on the

cobas c111 instrument. The crypto module is used for

enabling of the development channel applications.

Cleaner bottle A bottle with special cleaner ("CLEAN" Cat. No. 04774248190)

is placed on the reagent disk on the cobasc111 instrument.

(With development channel applications, an extra wash cycle

is automatically defined after each pipetting action.)

3rd-party reagents The required auxiliary fluids (reagents, calibrators, controls,

diluents) are available in standard fluid bottles.

Bottles for development

channel reagents, calibrators,

controls, and diluents

Dedicated non-barcoded bottles are used. These are available

from Roche. Each bottle holds up to 20 mL of fluid.

Table 3 Requirements for the cobas c111 instrument

Item Precondition

Printing of test definitions The printing was tested in the Development Channel

Programming Software and works correctly.

(These tests will be performed by a service representative.)

Application barcode A barcode generated and printed using the Development

Channel Programming Software has been successfully read

on the cobas c111 instrument.

(These tests will be performed by a service representative.)

Table 4 Preconditions that must be met before using development channels in routine

processing

Item Precondition

Application information Ideally, a package insert from the reagent supplier is available,

informing about volumes, wavelengths, incubation times, and

so on.

This basic application information is translated into

development channel parameters.

Basic tests (calibration, quality control, within-run precision

and method comparison) are performed by the customer to

assess the development channel parameters.

Table 5 Information that needs to be available

To ensure the highest effectiveness of probe cleaning, extra wash cycles are performed

automatically by the cobas c111 instrument when using development channel

applications.

Roche Diagnostics

Development Channel Operator’s Manual · Version 1.1 15

cobas c111 Operation

Setting up the Development Channel Programming Software

Operation

The following sections describe the operation of the Development Channel

Programming Software.

Setting up the Development Channel Programming Software

To integrate the Development Channel Programming Software in your computer

environment, you need to adjust some settings.

a To set up the Development Channel Programming Software

1

Choose Config.

The configuration window is displayed.

2

Choose the Settings tab.

3

In the Template Path box, define the folder where the development channel

templates will be saved.

This must be a subdirectory of the directory where you saved the Development

Channel Programming Software, and its name must be Templates.

Choose to display and select the folder.

4

In the DCA Path box, define the folder where you want to save the development

channel applications.

This must be a subdirectory of the directory where you saved the Development

Channel Programming Software, and its name must be Applications.

Choose to display and select the folder.

o For information on the layout of the main window and the functions of the buttons, see

Main screen on page 39.

o For information on the use of the online Help, see Online Help on page 42.

o Screen representations shown in this documentation are for illustrative purposes only.

The screens do not necessarily show valid data.

Figure 1

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16 Development Channel Operator’s Manual · Version 1.1

Operation cobas c111

Setting up the Development Channel Programming Software

5

Select the Display ID Column box to display in the Definitions area the ID of each

definition item.

Displaying these IDs makes navigation in the Definitions area easier.

Clear the box if you do not wish to display the IDs.

a To set up the barcode printing

1

Choose Config.

The configuration window is displayed.

2

Choose the Printer tab.

3

In the Default Application Barcode Printer box, define the printer you want to use

for printing barcode transfer sheets.

Choose Setup to display a dialog box for selecting a printer.

(For details on defining a printer, see the relevant documentation for the

operating system you are using on your computer.)

4

In the Default Bottle Barcode Printer box, define the printer you want to use for

printing labels.

Choose Setup to display a dialog box for selecting a printer.

(For details on defining a printer, see the relevant documentation for the

operating system you are using on your computer.)

5

In the Paper Format box, define the paper size.

Choose to display the paper sizes that are available and to select one.

Figure 2

Figure 3

Roche Diagnostics

Development Channel Operator’s Manual · Version 1.1 17

cobas c111 Operation

Defining development channel applications

a To display information on the Development Channel Programming

Software

1

Choose Config.

The configuration window is displayed.

2

Choose the Info tab.

The Info tab contains additional information on the Development Channel

Programming Software.

Defining development channel applications

This section describes the overall workflow for defining development channel

applications.

e

For details on permitted values, select the entry for the value and consult the text in the

Input Advice area on the screen. For additional information see the appropriate section in

Software description on page 39 and following.

Figure 4

o Modifying an existing development channel application calls for renewed installation of

the application on the cobas c111 instrument. If the new application requires different

reagents, these need to be installed. You also need to calibrate or recalibrate all

reagents that are used by this application.

o In the Development Channel Programming Software always use the point as the

decimal separator.

Roche Diagnostics

18 Development Channel Operator’s Manual · Version 1.1

Operation cobas c111

Defining development channel applications

a To define a development channel application from scratch

1

If required, switch on and start up the computer where the Development Channel

Programming Software is installed.

2

Start the Development Channel Programming Software.

Color coding

3

In the Templates area, choose a template (templates are classified according to the

reaction modes.)

4

Choose .

A dialog box is displayed, asking you to confirm the creation.

5

Choose Yes to create the new application.

A dialog box is displayed for defining the application name.

A Templates area.

B Choose to create a new application from

the selected template.

C Applications area.

D Choose to open the selected application.

E Choose to create a copy of the selected

application.

F Definitions area.

G Choose to save the application.

H Input Advice area.

Figure 5

B

D

A

C

E

F

HG

Missing value.

Invalid or inconsistent value.

Read-only data.

Data that are, for example, set automatically by the system or that are not

currently relevant because some other value has not been defined. These data

will be printed.

If you want to create a new application on the basis of an existing application, follow the

procedure in Changing existing development channel applications on page 11.

Roche Diagnostics

Development Channel Operator’s Manual · Version 1.1 19

cobas c111 Operation

Defining development channel applications

6

Type a meaningful name for the application.

(This name will be displayed in the Applications area.)

7

Choose Save to save the new application.

The new application data are displayed in the Definitions area.

8

Work through the definitions sections and define the values.

Type or select the required data.

To save the current data, choose .

(If you open another development channel application, the data of the current

application are automatically saved before the other application is opened.)

General a) Define the application names and some basic parameters such as the

application code and the application version.

e

See General on page 45.

Diluents b) Define the diluents and pre-diluents.

e

See Diluent on page 46.

Calibration c) Define the calibrators.

e

See Calibration on page 48.

d) Define the dilution values used in the standard series.

e

See Dilution of Standard Series on page 50.

Control Parameters e) Define up to three different controls, QC flag handling, and control intervals.

e

See Control Parameters on page 52.

Pipetting f) Define the use of pre-diluents and post-dilutions for samples and controls.

e

See Pipetting on page 53.

g) Define the application-specific pipetting volumes for samples and reagents.

e

See Pipetting Volumes on page 54.

Calculation h) Define the calculation model and the associated calculation and wavelength

parameters.

e

See General on page 55.

i) Define the standard and laboratory units.

e

See Units on page 57.

j) Define the parameters for calculating and checking calibration results.

e

See Calibration on page 58.

Roche recommends using names that are different from existing Roche application names;

for example by prefixing the name with DC. This prevents mix-up of reagents and allows

comparison of methods between the Roche applications and those defined using the

Development Channel Programming Software.

Roche Diagnostics

20 Development Channel Operator’s Manual · Version 1.1

Operation cobas c111

Defining development channel applications

Checks k) Define the parameters for checking the endpoint stability.

e

See Endpoint on page 60.

l) Define parameters for checking the kinetic linearity.

e

See Kinetic on page 61.

m) Define the parameters for checking high and low activity levels.

Activity in this context defines the change of absorbance signal per time

interval.

e

See High/Low Activity on page 62.

n) Define the test ranges.

A test range represents an application-specific measuring range within which

the concentration-signal ratio is linear.

e

See Test Range on page 64.

o) Define the ranges for each individual calibration set point.

e

See Lin Reg Curve Range on page 65.

p) Define the parameters for checking the concentration level.

This check is only required if the value for Calibration Replicates is 2.

e

See Replicate Deviation on page 67.

q) Define The parameters concerning calculation and checking of antigen excess.

e

See Antigen Excess on page 69.

Result evaluation r) Define the parameters concerning the evaluation of sample results.

e

See Result Evaluation on page 72.

Reagent data s) Define the expiry date, number of tests and on-board stability for reagents.

e

See Reagent Data on page 73.

Pre-diluent data t) Define the expiry date, volumes, and on-board stability for pre-diluents.

e

See Pre-Diluent Data on page 74.

Diluent data u) Define the expiry date, volumes, and on-board stability for special diluents.

e

See Special Diluent Data on page 75.

9

Check that all required parameters are consistently defined.

e

For information on the interpretation of the symbols, see Main screen on page 39.

10

Choose to save the data.

A There should be no , or symbols preceding the sections.

Figure 6

A

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Roche cobas c 111 User manual

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