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).
Copyright © 2008-2012, Roche Diagnostics International Ltd. All rights reserved.
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.
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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
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.
Roche Diagnostics
12 Development Channel Operator’s Manual · Version 1.1
Overview cobas c111
Installing development channel applications on the cobas c111 instrument
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
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
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