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cobas c111 system
Operator’s Manual Version 3.0
cobas c 111
Document information
Revision history
Edition notice
Manual version |
Software version |
Revision date |
Changes |
1.0 |
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July 2006 |
First publication. |
2.0 |
2.0 |
December 2007 |
Full mode added. |
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Improved calibration concept. |
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Additional maintenance and |
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troubleshooting information. |
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Additions, improvements, and |
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corrections. |
3.0 |
3.0 |
June 2009 |
Inventory, processing sequence, |
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and ratio functions added. |
Improvements and corrections.
Layout upgraded.
The cobas c111 instrument is a continuous random-access analyzer intended for the in vitro determination of clinical chemistry and electrolyte parameters in serum, plasma, urine or whole blood (HbA1c). It is optimized for small throughput workloads of approximately samples per day, utilizing photometric analysis and an optional unit for ion selective electrodes (ISE).
This manual is for users of the cobas c111 instrument.
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 GmbH reserves the right to make any changes necessary without notice as part of ongoing product development.
Any customer modification to the instrument will render the warranty or service agreement null and void.
Software updates are done by service representatives.
Intended use The cobas c111 instrument is a continuous random-access analyzer intended for the in vitro determination of clinical chemistry and electrolyte parameters in serum, plasma, urine or whole blood (HbA1c).
It is important that the operators read this manual thoroughly before using the system.
Copyrights © 2009, Roche Diagnostics GmbH. 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.
Roche Diagnostics
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Operator’s Manual · Version 3.0 |
cobas c111
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 2nd Edition
o EN/IEC 61010-2-101 1st Edition
The Operator’s manual meets the European Standard EN 591.
Regulatory compliance is demonstrated by the following marks:
Complies with European Union (EU) Directive 98/79/EC.
Issued by Underwriters Laboratories, Inc. (UL) for Canada and the
US.
C ® 
US
Contact addresses
Manufacturer |
Roche Diagnostics Ltd. |
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Forrenstrasse |
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CH-6343 Rotkreuz |
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Switzerland |
Distributor |
Roche Diagnostics GmbH |
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Sandhofer Strasse 116 |
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D-68305 Mannheim |
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Germany |
Roche Diagnostics
Operator’s Manual · Version 3.0 |
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cobas c 111
Roche Diagnostics
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Operator’s Manual · Version 3.0 |
cobas c111
Table of contents
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Document information |
2 |
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Contact addresses |
3 |
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Table of contents |
5 |
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Preface |
7 |
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How to use this manual |
7 |
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Online Help system |
7 |
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Conventions used in this manual |
8 |
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System Description |
Part |
A |
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1 |
Safety |
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Safety classification |
A–5 |
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Safety information |
A–5 |
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Data security |
A–10 |
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License notices |
A–11 |
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Legal liability |
A–11 |
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Disposal recommendation |
A–12 |
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Safety labels |
A–13 |
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2 Introduction to the instrument |
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Overview |
A–17 |
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User interface |
A–20 |
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Wizards |
A–21 |
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Daily operation |
A–22 |
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Maintenance |
A–34 |
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System status |
A–35 |
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3 |
Hardware |
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Covers and panels |
A–39 |
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LEDs |
A–41 |
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Main components |
A–43 |
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Hardware overview |
A–44 |
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Technical specifications |
A–66 |
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5 |
Software |
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Introduction |
A–71 |
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Screen layout |
A–72 |
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Display items |
A–73 |
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Workflows and wizards |
A–74 |
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Working with the user interface |
A–75 |
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Key screens |
A–84 |
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Color interpretation for LEDs |
A–122 |
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Buttons |
A–124 |
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Operation |
Part |
B |
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6 |
Daily operation |
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Introduction |
B–5 |
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Starting the shift |
B–10 |
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Preparing the system |
B–12 |
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Analyzing samples |
B–34 |
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Validating sample results |
B–51 |
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Performing calibrations |
B–59 |
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Performing QC |
B–68 |
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Finishing the shift |
B–77 |
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Logging off |
B–88 |
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Switching off the system |
B–88 |
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Using the barcode scanner |
B–89 |
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6 |
Special operations |
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Deleting sample orders |
B–93 |
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Deleting sample results |
B–94 |
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Calibration |
B–95 |
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Deleting QC results |
B–96 |
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Lot handling |
B–98 |
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Exporting data |
B–104 |
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Importing data |
B–111 |
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Preparing a new disk |
B–116 |
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Assigning tests to test tabs |
B–119 |
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Deleting bottle sets from the Inventory list |
B–120 |
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Refilling printer paper |
B–122 |
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Removing condensation water |
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from the reagent cooler |
B–124 |
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Replacing the probe |
B–125 |
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Connecting and disconnecting the |
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external fluid containers |
B–127 |
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Adjusting the touchscreen |
B–130 |
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Cleaning the touchscreen |
B–131 |
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7 |
Configuration |
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Introduction |
B–135 |
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Applications |
B–137 |
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Configuration |
B–157 |
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Maintenance |
Part |
C |
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8 General maintenance |
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Overview |
C–5 |
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Maintenance actions |
C–8 |
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Operator’s Manual · Version 3.0 |
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cobas c 111
Troubleshooting |
Part |
D |
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9 |
Messages and alarms |
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About messages |
D–5 |
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Message screen |
D–5 |
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Acoustic signals |
D–6 |
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Alarm monitor |
D–6 |
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List of alarm messages |
D–10 |
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10 |
Result flags |
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About flags |
D–25 |
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Safety |
D–27 |
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List of flags |
D–28 |
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11 |
Troubleshooting |
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Introduction |
D–41 |
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Dealing with exceptional situations |
D–42 |
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Reacting to messages |
D–44 |
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Detailed procedures |
D–46 |
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ISE |
Part |
E |
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12 |
ISE description |
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Overview |
E–5 |
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Hardware |
E–9 |
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Basic operation |
E–12 |
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Technical specifications |
E–13 |
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13 |
ISE operation |
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Daily operation |
E–17 |
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Replacing ISE fluid bottles |
E–30 |
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Replacing electrodes |
E–32 |
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Cleaning the ISE tower off the instrument |
E–36 |
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14 |
ISE maintenance |
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Introduction |
E–41 |
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ISE maintenance actions |
E–42 |
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15 |
ISE troubleshooting |
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Introduction |
E–69 |
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Safety |
E–70 |
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List of ISE flags |
E–71 |
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Reacting to error messages |
E–80 |
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Glossary and Index |
Part |
F |
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Glossary |
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F–3 |
Index |
F–11 |
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Revisions |
Part |
G |
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18 Revisions |
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Roche Diagnostics
6 |
Operator’s Manual · Version 3.0 |
cobas c111
Preface
The cobas c111 instrument is a continuous random-access analyzer intended for the in vitro determination of clinical chemistry and electrolyte parameters in serum, plasma, urine or whole blood (HbA1c). It is optimized for small throughput workloads of approximately samples per day, utilizing photometric analysis and an optional unit for ion selective electrodes (ISE).
This manual describes the cobas c111 features and general operational concepts, and it provides operating, maintenance, and emergency procedures.
How to use this manual
o Keep this Operator’s Manual in a safe place to ensure that it is not damaged and remains available for use.
o This Operator’s Manual should be easily accessible at all times.
To help you find information quickly, there is a table of contents at the beginning of the manual and each chapter. In addition, a complete index can be found at the end.
Online Help system
The cobas c111 instrument has a context-sensitive online Help feature to aid in its operating. “Context-sensitive” means that wherever you are located within the cobas c111 software, choosing Help ( 
) displays Help text relating to that area of the software. The online Help offers a quick and convenient way of finding information, such as explanations of screens and dialog boxes and on how to perform particular tasks.
Roche Diagnostics
Operator’s Manual · Version 3.0 |
7 |
cobas c 111
Conventions used in this manual
Visual cues are used to help locate and interpret information in this manual quickly.
This section explains the formatting conventions used in this manual.
Symbols The following symbols are used:
Symbol |
Used for |
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a |
Start of procedure |
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o |
List item |
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e |
Cross-reference |
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h |
Call-up (software navigation path) |
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Color of display item on the screen |
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Tip |
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Safety alert |
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Electrical and electronic equipment marked with this symbol are |
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covered by the European directive WEEE. |
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The symbol denotes that the equipment must not be disposed of in |
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the municipal waste system. |
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Buttons When used for identification purposes, a generic form of the buttons is used, without color or navigation indicators.
Screenshots The screen representations shown in this publication are for illustrative purposes only. The screens do not necessarily show valid data.
Roche Diagnostics
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Operator’s Manual · Version 3.0 |
cobas c111
Abbreviations The following abbreviations are used:
Abbreviation |
Definition |
C |
|
Cfas |
Calibrator for automated systems |
D |
|
DIL |
Diluent |
DM |
Data management |
DRAM |
Dynamic random access memory |
E |
|
e.g. |
Exempli gratia – for example |
EMC |
Electromagnetic compatibility |
EN |
European standard |
I |
|
i.e. |
Id est – that is to say |
IEC |
International Electrical Commission |
ISE |
Ion selective electrode |
L |
|
LED |
Light-emitting diode |
LIS |
Laboratory information system |
LLD |
Liquid level detection |
N |
|
n/a |
Not applicable |
Q |
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QC |
Quality control |
R |
|
REF |
Reference solution for ISE unit |
ROM |
Read only memory |
S |
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SD |
Standard deviation |
SRAM |
Static random access memory |
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Roche Diagnostics
Operator’s Manual · Version 3.0 |
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cobas c 111
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Units Abbreviation |
Description |
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°C |
degree centigrade |
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µL |
microliter |
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µm |
micrometer |
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A |
ampère |
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cm |
centimeter |
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h |
hour |
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Hz |
hertz |
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LB |
pound (weight) |
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in |
inch |
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kg |
kilogram |
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kVA |
kilo volt-ampere |
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L |
liter |
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m |
meter |
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MB |
megabytes |
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min |
minute |
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mL |
milliliter |
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mm |
millimeter |
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nm |
nanometer |
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s |
second |
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V |
volt |
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VA |
volt-ampère |
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V AC |
volt alternating current |
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V DC |
volt direct current |
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W |
watt |
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Roche Diagnostics
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Operator’s Manual · Version 3.0 |
System Description A
1 |
Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
A-3 |
2 |
Introduction to the instrument . . . . . . . . . . . . . . . . . . . . . . . . . |
A-15 |
3 |
Hardware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
A-37 |
5 |
Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . |
A-69 |
cobas c111 |
1 Safety |
Table of contents
Safety
Protecting yourself and the environment
In this chapter, you will find information on the safe operation of the cobas c111 instrument.
In this chapter
Chapter 1
Safety classification ...................................................................................................... |
A-5 |
Safety information ...................................................................................................... |
A-5 |
Transport ............................................................................................................... |
A-5 |
Electrical safety ...................................................................................................... |
A-5 |
Optical safety ......................................................................................................... |
A-6 |
Mechanical safety .................................................................................................. |
A-6 |
Instrument covers .................................................................................................. |
A-6 |
Operation and maintenance ................................................................................. |
A-6 |
Biohazardous materials ......................................................................................... |
A-6 |
Waste ...................................................................................................................... |
A-7 |
Reagents and other working solutions ................................................................. |
A-7 |
Installation ............................................................................................................. |
A-7 |
Environmental conditions .................................................................................... |
A-7 |
Power interruption ................................................................................................ |
A-8 |
Electromagnetic devices ........................................................................................ |
A-8 |
Approved parts ...................................................................................................... |
A-8 |
Third-party software ............................................................................................. |
A-8 |
Operator qualification ........................................................................................... |
A-9 |
Operation over an extended period of time ......................................................... |
A-9 |
Cross contamination of sample ............................................................................ |
A-9 |
Insoluble contaminants in sample ........................................................................ |
A-9 |
Spillage ................................................................................................................... |
A-9 |
Data security .............................................................................................................. |
A-10 |
License notices ........................................................................................................... |
A-11 |
Legal liability .............................................................................................................. |
A-11 |
Roche Diagnostics
Operator’s Manual · Version 3.0 |
A-3 |
1 Safety |
cobas c 111 |
Table of contents |
|
Disposal recommendation ........................................................................................ |
A-12 |
Disposal label ....................................................................................................... |
A-12 |
Disposal of external components ....................................................................... |
A-12 |
Disposal of the instrument ................................................................................. |
A-12 |
Constraint ............................................................................................................ |
A-12 |
Safety labels ................................................................................................................ |
A-13 |
Roche Diagnostics
A-4 |
Operator’s Manual · Version 3.0 |
cobas c111 |
1 Safety |
Safety classification
Safety classification
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Before you attempt to use the cobas c111 instrument, you must be fully familiar with |
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the following symbols and their meanings: |
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Warning |
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Indicates a hazardous situation which, if not avoided, could result in death or serious |
WARNING |
injury. |
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Caution |
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Indicates a hazardous situation which, if not avoided, may result in minor or moderate |
CAUTION |
injury. |
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NOTICE |
Notice |
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Indicates a hazardous situation which, if not avoided, may result in property damage. |
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Safety information
Before operating the cobas c111 instrument, it is essential that you both read and understand the safety information listed below.
Read all Roche safety notices carefully and make sure you understand them.
Transport
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Injury from heavy loads |
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You may injure your hands, fingers, or back when putting the analyzer in place. Carry the |
WARNING |
analyzer according to the transport instructions. |
Electrical safety
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Electrical shock by electronic equipment |
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Do not attempt to work in any electronic compartment. Installation, service, and repair |
WARNING |
must only be performed by authorized and qualified personnel. |
Electrical safety
Connect the analyzer to grounded power outlets only (IEC protection class 1). All peripheral devices that are connected to the cobas c111 instrument must comply with safety standard IEC 60950 for information technology equipment, or with IEC 61010-1, UL 61010- 1 for laboratory use instruments.
Roche Diagnostics
Operator’s Manual · Version 3.0 |
A-5 |
1 Safety |
cobas c 111 |
Safety information
Optical safety
WARNING
Loss of sight
The intense light of the LEDs may severely damage you eyes. Do not stare into the LEDs.
Scanning equipment using LED technology is covered by the international standard IEC 60825-1 LED Safety: Class 1.
Mechanical safety
|
Personal injury or damage to the analyzer due to contact with instrument |
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mechanism |
WARNING |
Do not touch moving parts during instrument operation. |
Instrument covers
|
Personal injury or damage to the analyzer due to contact with instrument |
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mechanism |
WARNING |
Keep all covers closed, operate them as instructed on the screen. |
Operation and maintenance
|
Personal injury or damage to the analyzer due to contact with instrument |
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mechanism |
WARNING |
Do not touch any parts of the instrument other than those specified. During operation and |
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maintenance of the instrument, proceed according to the instructions. |
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Biohazardous materials
Infection by biohazardous materials
Contact with samples containing material of human origin may result in infection. All WARNING materials and mechanical components associated with samples of human origin are
potentially biohazardous.
oBe sure to wear protective equipment. Take extra care when working with protective gloves; these can easily be pierced or cut, which can lead to infection.
o If any biohazardous material is spilled, wipe it up immediately and apply disinfectant.
oIf waste solution contacts your skin, wash it off immediately with water and apply a disinfectant. Consult a physician.
Roche Diagnostics
A-6 |
Operator’s Manual · Version 3.0 |
cobas c111 |
1 Safety |
Safety information
Waste
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Infection by waste solution |
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Contact with waste solution may result in infection. All materials and mechanical compo- |
WARNING |
nents associated with the waste systems are potentially biohazardous. |
oBe sure to wear protective equipment. Take extra care when working with protective gloves; these can easily be pierced or cut, which can lead to infection.
o If any biohazardous material is spilled, wipe it up immediately and apply disinfectant.
oIf waste solution contacts your skin, wash it off immediately with water and apply a disinfectant. Consult a physician.
Reagents and other working solutions
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Injury through reagents and other working solutions |
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Direct contact with reagents, cleaning solutions, or other working solutions may cause |
WARNING |
personal injury. |
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When handling reagents, exercise the precautions required for handling laboratory |
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reagents, observe the cautions given in the package insert, and observe the information |
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given in the Safety Data Sheets available for Roche Diagnostics reagents and cleaning |
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solutions. |
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Skin inflammation caused by reagents |
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Direct contact with reagents may cause skin irritation, inflammation, or burns. |
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When handling reagents, be sure to wear protective equipment and observe the cautions |
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given in the package insert. |
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Installation
Incorrect results or damage to the analyzer due to wrong installation
Follow the specified installation instructions carefully.
WARNING
Environmental conditions
Incorrect results or damage to the analyzer due to heat and humidity
Use the instrument indoor only.
WARNING
eFor details on the required environmental conditions, see Environmental conditions on page A-66.
Roche Diagnostics
Operator’s Manual · Version 3.0 |
A-7 |
1 Safety |
cobas c 111 |
Safety information
Power interruption
NOTICE |
Data loss or damage to the system due to voltage drop |
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By a power failure or momentary voltage drop the operation unit or software of this system |
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may get damaged or data loss may occur. Use only uninterruptible power supply. |
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Electromagnetic devices
Malfunction of instrument and incorrect results due to interfering electromagnetic fields
WARNING |
Devices that emit electromagnetic waves may cause the instrument to malfunction. Do not |
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operate the following devices in the same room where the system is installed: |
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o |
Mobile phone |
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o |
Transceiver |
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o |
Cordless phone |
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o Other electrical devices that generate electromagnetic waves |
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NOTICE |
Instructions for in vitro diagnostic (IVD) equipment for professional use |
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The IVD equipment complies with the emission and immunity requirements described in |
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the particular requirements for IVD medical equipment of the EN/IEC 61326-2-6 standard. |
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The electromagnetic environment should be evaluated prior to operation of the device. |
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Class B FCC rule compliance
This equipment has been tested and found to comply with the limits for Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interferences when the equipment is operated in a residential area. However, this equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the present manual, may cause harmful interference to radio communications.
The electromagnetic environment should be evaluated prior to operation of the device.
Approved parts
Malfunction of instrument and incorrect results due to nonapproved parts
Use of nonapproved parts or devices may result in malfunction of the instrument and may WARNING render the warranty null and void. Only use parts and devices approved by Roche Diag-
nostics.
Third-party software
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Malfunction of instrument and incorrect results due to third-party software |
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Installation of any third-party software that is not approved by Roche Diagnostics may |
WARNING |
result in incorrect behavior of the system. Do not install any nonapproved software. |
Roche Diagnostics |
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A-8 |
Operator’s Manual · Version 3.0 |
cobas c111 |
1 Safety |
Safety information
Operator qualification
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Incorrect results or damage to the analyzer due to wrong operation |
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Operators are required to have a profound knowledge of relevant guidelines and norms as |
WARNING |
well as the information and procedures contained in the Operator’s Manual. |
oDo not carry out operation and maintenance unless you have been trained by Roche Diagnostics.
oCarefully follow the procedures specified in the Operator’s Manual for the operation and maintenance of the system.
oLeave maintenance that is not described in the Operator’s Manual to trained service representatives.
o Follow standard laboratory practices, especially when working with biohazard material.
Operation over an extended period of time
Fatigue due to long hours of operation
Looking at the monitor screen over an extended period of time may lead to fatigue of your CAUTION eyes or body. Take a rest for 10 to 15 minutes every hour to relax. Avoid spending more
than 6 hours per day looking at the monitor screen.
Cross contamination of sample
Incorrect results due to carryover
Traces of analytes or reagents may be carried over one test to the next. Take adequate WARNING measures (e.g. sample aliquoting) to safeguard additional testing and to avoid potentially
false results.
Insoluble contaminants in sample
Incorrect results and interruption of analysis due to contaminated samples
Insoluble contaminants in samples may cause clogging or pipetting volume shortage and WARNING deterioration in measurement accuracy. When loading samples on the instrument, make
sure that samples contain no insoluble contaminants such as fibrin or dust.
Spillage
NOTICE |
Malfunction due to spilled liquid |
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Any liquid spilled on the instrument may result in malfunction of the instrument. If liquid |
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does spill on the instrument, wipe it up immediately and apply disinfectant. |
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Roche Diagnostics
Operator’s Manual · Version 3.0 |
A-9 |
1 Safety |
cobas c 111 |
Data security |
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Data security |
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Unauthorized access and data loss due to malicious software and hacker attacks |
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Portable storage media can be infected with and transmit computer malware, which may |
CAUTION |
be used to gain unauthorized access to data or cause unwanted changes to software. |
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The cobas c111 is not protected against malicious software and hacker attacks. |
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The customers are responsible for IT security of their IT infrastructure and for protecting it |
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against malicious software and hacker attacks. Failure to do so may result in data loss or |
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render the cobas c111 unusable. |
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Roche recommends the following precautions: |
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o Allow connection to authorized external devices only. |
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o Ensure that all external devices are protected by appropriate security software. |
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o Ensure that access to all external devices is protected by appropriate security equip- |
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ment. |
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o Do not copy or install any software on the cobas c111 unless it is part of the system |
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software or you are instructed to do so by a Roche service representative. |
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o If additional software is required, contact your Roche service representative to ensure |
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validation of the software in question. |
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o Do not use the USB ports to connect other storage devices unless you are instructed to |
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do so by official user documentation or a Roche service representative. |
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o Exercise utmost care when using external storage devices such as USB flash drives, |
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CDs, or DVDs. Do not use them on public or home computers while connecting to the |
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cobas c111. |
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o Keep all external storage devices in a secure place and ensure that they can be |
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accessed by authorized persons only. |
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e For further information, contact your Roche service representative. |
Roche Diagnostics
A-10 |
Operator’s Manual · Version 3.0 |
cobas c111 |
1 Safety |
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License notices |
License notices |
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Malfunction of instrument and incorrect results due to software modifications by |
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the customer |
WARNING |
The cobas c111 instrument uses open source software. Among other things, the holders |
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of the proprietary rights grant licenses under the terms of the GNU General Public Licence |
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(GPL edition 2 or above) as well as under the GNU Lesser General Public License (LGPL). |
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The cobas c111 instrument has been designed to be operated with the unmodified soft- |
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ware as shipped. The user assumes full responsibility for changing any part of the open |
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source software, which excludes any liability of Roche Diagnostics Ltd. |
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This program is distributed without any warranty; without even the implied warranty of |
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merchantability or fitness for a particular purpose. See the GNU General Public License for |
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more details (www.gnu.org/copyleft/gpl.html). |
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The source code of the used open source software is part of MIKRAPs CPUX255LCDNET |
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board support package and may be obtained from SYSGO (http://www.sysgo.com/prod- |
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ucts/board-support-packages/). |
Legal liability |
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Roche Diagnostics Ltd. assumes only limited liability when using the cobas c 111 |
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instrument in conjunction with the cobas c111 Development Channel Programming |
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Software. |
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For detailed information on this matter refer to the latest version of the Development |
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Channel Registration Form cobas c111 and the cobas c111 Development Channel |
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Operator’s Manual. |
Roche Diagnostics
Operator’s Manual · Version 3.0 |
A-11 |
1 Safety |
cobas c 111 |
Disposal recommendation
Disposal recommendation
All electrical and electronic products should be disposed of separately from the municipal waste system. Proper disposal of your old appliance prevents potential negative consequences for the environment and human health.
Disposal label
Electrical and electronic equipment marked with this symbol are covered by the European directive on waste electrical and electronic equipment (WEEE) 2002/96/EC.
The symbol denotes that the equipment must not be disposed of in the municipal waste system.
Disposal of external components
External components such as the scanner and the ISE power supply, which are marked with the crossed-out wheeled bin symbol, are covered by the European Directive 2002/96/EC (WEEE).
These items must be disposed of via designated collection facilities appointed by government or local authorities.
For more information about disposal of your old products, contact your city office, waste disposal service or your local service representative.
Disposal of the instrument
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The instrument must be treated as biologically contaminated hazardous waste. Final dis- |
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posal must be organized in a way that does not endanger waste handlers. As a rule, such |
WARNING |
equipment must be sterile before it is passed on for final disposal. |
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For more information contact your local service representative.
Constraint
It is left to the responsible laboratory organization to determine whether control unit components are contaminated or not. If contaminated, treat in the same way as the instrument.
Roche Diagnostics
A-12 |
Operator’s Manual · Version 3.0 |
cobas c111 |
1 Safety |
Safety labels
Safety labels
Read all safety labels on the instrument and equipment.
The following illustration shows where on the instrument labels are displayed.
A B
AThis label on the electrode block of the ISE unit indicates that there is a danger of hazardous situations arising within the vicinity of this label, which may result in death or serious injury. The relevant laboratory procedures on safe use must be observed.
(You will find this label only if an ISE unit is installed.)
BThis label on the main cover indicates that there are potential biohazards within the vicinity of this label, which may result in death or serious injury.
The relevant laboratory procedures on safe use must be observed.
Figure A-1 |
Safety labels on the cobas c111 instrument |
In addition to safety labels on the instrument, there are safety notes in the corresponding parts of the Operator’s Manual.
These safety notes give more detailed information about potentially hazardous situations that may arise during daily operation or when carrying out maintenance procedures.
When working with the instrument, be sure to observe both the safety labels on the instrument and the safety notes in the Operator’s Manual.
Roche Diagnostics
Operator’s Manual · Version 3.0 |
A-13 |
1 Safety |
cobas c 111 |
Safety labels
Roche Diagnostics
A-14 |
Operator’s Manual · Version 3.0 |
cobas c111 |
2 Introduction to the instrument |
Table of contents
Introduction to the instrument
What you need to know before you start
In this chapter, you will find basic information on the features that are relevant for working with the cobas c111 instrument.
In this chapter
Chapter 2
Overview .................................................................................................................... |
A-17 |
Principles of operation ........................................................................................ |
A-19 |
User interface ............................................................................................................. |
A-20 |
Wizards ...................................................................................................................... |
A-21 |
Daily operation .......................................................................................................... |
A-22 |
Overview .............................................................................................................. |
A-22 |
Reagent and diluent handling ............................................................................. |
A-25 |
Calibration ........................................................................................................... |
A-26 |
Calibration type ............................................................................................. |
A-27 |
Calibration sequence ..................................................................................... |
A-28 |
Calibration status of a set .............................................................................. |
A-28 |
Calibration result storage .............................................................................. |
A-28 |
Validating calibration results ........................................................................ |
A-29 |
Calibration procedures .................................................................................. |
A-29 |
Quality control (QC) .......................................................................................... |
A-30 |
Sample handling .................................................................................................. |
A-31 |
Order handling .................................................................................................... |
A-32 |
Results .................................................................................................................. |
A-34 |
Maintenance .............................................................................................................. |
A-34 |
System status .............................................................................................................. |
A-35 |
Roche Diagnostics
Operator’s Manual · Version 3.0 |
A-15 |
2 Introduction to the instrument |
cobas c111 |
Table of contents
Roche Diagnostics
A-16 |
Operator’s Manual · Version 3.0 |
cobas c111 |
2 Introduction to the instrument |
Overview
Overview
The cobas c111 instrument is a continuous random-access analyzer intended for the in vitro determination of clinical chemistry and electrolyte parameters in serum, plasma, urine or whole blood (HbA1c). It is optimized for small throughput workloads of approximately samples per day, utilizing photometric analysis and an optional unit for ion selective electrodes (ISE).
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Only trained personnel working in a professional laboratory environment may |
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operate the cobas c 111 instrument. |
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Incorrect results or damage to the analyzer due to wrong operation |
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Operators are required to have a profound knowledge of relevant guidelines and norms as |
WARNING |
well as the information and procedures contained in the Operator’s Manual. |
oDo not carry out operation and maintenance unless you have been trained by Roche Diagnostics.
oCarefully follow the procedures specified in the Operator’s Manual for the operation and maintenance of the system.
oLeave maintenance that is not described in the Operator’s Manual to trained service representatives.
o Follow standard laboratory practices, especially when working with biohazard material.
Features As part of the cobas family of instruments, the cobas c111 instrument offers small laboratories the following advantages:
o High analytical performance
The same bulk reagents, 12-wavelength photometer and disposable cuvettes generate results that are highly correlated to other cobas instruments.
oEfficient operation
Cooled, exchangeable reagent disks ensure economical reagent use; disposable cuvette segments allow for easy cuvette loading and removal.
oHigh reliability, low maintenance
Innovative "low impact" instrument design and software-driven preventive maintenance improves up-time and reduces maintenance costs.
oAdaptable user interface
The built-in color touchscreen, process-driven software, and reagent and sample barcode entry adapts to users of different skills and access levels.
oHigh safety standards
Built-in safety devices, such as level detection, tube bottom detection, cuvette quality control, and ISE clot detection anticipate potential hazards during operation.
o Flexible sampling
Eight on-board sample positions accommodate virtually any type of sample carrier, and enable continuous sample placing and removal during operation.
oData management
Bidirectional RS-232 and USB ports, on-board thermal printer, and drivers offer the latest in data management capabilities.
Roche Diagnostics
Operator’s Manual · Version 3.0 |
A-17 |
2 Introduction to the instrument |
cobas c111 |
Overview
Measuring principles
A first look at the instrument
Measurements are performed by means of an absorbance photometer and optionally an ISE (ion selective electrode) module that uses ion selective potentiometry.
A B C D
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M N |
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Left service flap (covers wash station, ISE |
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H |
Touchscreen |
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tower, tubing) |
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I |
Fluid connectors |
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Main cover (covers rotor, reagents, cuvettes, |
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Right service flap (covers photometer unit, |
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photometer unit) |
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sample area) |
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C |
Main switch |
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K |
Printer panel |
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Transfer head (holds probe) |
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Main cover LED |
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E |
Rear service flap (covers computer boards, |
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M |
Paper slot |
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power supply, degasser) |
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N |
Release button for printer panel |
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F |
Sample area LED |
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USB connector (not shown) |
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G |
Sample area (space for 8 sample tubes) |
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Figure A-2 |
The cobas c 111 instrument |
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Roche Diagnostics
A-18 |
Operator’s Manual · Version 3.0 |
cobas c111 |
2 Introduction to the instrument |
Overview
Principles of operation
The cobas c111 main instrument uses absorption photometry for determining the amount of absorbance in a fluid. The absorbance is used to calculate the concentration in the solution.
Loading the sample The operator identifies the sample, places it on the instrument, and defines the order. (If you work with a host system, the order is defined automatically.)
Measuring process The measuring process for each test consists of forty regular cycles, each lasting 18 seconds. In each of these cycles, a measurement is taken, irrespective of what other actions take place during this cycle. The application definitions determine what is done in which cycle, and they also define which results are taken into account for the result calculation.
With each cycle, a new test can be started.
The basic process works as follows:
1.Checking the cuvette.
A measurement is taken to check the quality of the cuvette.
2.Pipetting reagent (R1) to the cuvette.
After each pipetting action, the system performs a wash cycle to minimize carryover. During this cycle, the probe and tubing are flushed with water and cleaner.
3.Wait.
The fluid needs to reach the prescribed temperature. Such a phase can last several cycles.
During the wait cycles, activities for other tests are performed.
4.Pipetting the next fluid.
Typically, this would be the sample. The details are defined in the application definitions.
5.Wait.
6.Pipetting the next fluid.
7.Wait.
8.And so on.
Calculating the results The test result is calculated on the basis of the photometric measurement results. During this process, various checks are performed to ensure that the whole measuring process was technically correct. If values are above or below predefined limits, the test result is flagged.
The results are stored on the system. This includes both the forty measurement results (raw data) and the calculated test result.
Sequence of processing For a given sample, the tests are processed in the order defined by the time required for their processing (number of cycles), starting with the one that takes the longest. This order can be altered manually by defining a specific process sequence list.
Status of the measuring process At any stage of the measuring process, the user can check its status on the screen.
Result data management The system provides storage space for the results of one working day. For backup purposes, the results must be exported to an external storage device once a day.
Roche Diagnostics
Operator’s Manual · Version 3.0 |
A-19 |
2 Introduction to the instrument |
cobas c111 |
User interface
User interface
The cobas c111 instrument is equipped with a touchscreen, an on-screen keyboard and four global action buttons. LEDs and acoustic signals let you know when it is safe to add or remove samples, reagents and other fluids.
With buttons and other display items, “traffic light” color coding is used: Green means OK, yellow: watch out, you need to do something, and red means that your intervention is required for processing to continue.
The screens have a clear and consistent layout and are easy to use. The topics are divided in the proven work areas: Overview for order and fluid handling, Workplace for result handling and details on orders, and Utilities for administration tasks.
e For details on the user interface, see Chapter 5 Software.
The following is an example of a screen. It contains the full range of display items.
A
B
C
D
E
AThe status line displays the system status.
BTabs represent the major work areas.
CThe headline characterizes the content or function of the screen. If the screen is part of a sequence of screens (wizard), the headline tells you where you are within this sequence.
DThe working area displays the main content of the screen.
EThe buttons vary depending on the content of the working area and the screen position within a series of steps (wizard).
F
G
FThe Help button leads to concise information that is relevant to the current screen and situation.
GThe global action buttons represent the functions that are permanently available: Start, Stop, Alarm, Line Feed. The LEDs next to them point to their status.
Figure A-3 |
Example of a screen |
Roche Diagnostics
A-20 |
Operator’s Manual · Version 3.0 |
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