Introduction - cobas Urisys 1100 Manual De Instrucciones

1. Introduction

Revision History
Manual version Software version
04 5.x
The Urisys 1100 system is a reflectance photometer designed to read and evaluate the urine test strips Combur
Combur Test and Combur Test* from Roche Diagnostics. It reads the strips under standard ized conditions, saves the results
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to memory and outputs them via its own inbuilt printer and/or serial interface.
The Urisys 1100 system is designed for In Vitro Diagnostic (IVD) use by qualified physicians and laboratory staff.
BIOHAZARD: Treat all samples of human origin as being potentially infectious.
Always observe good laboratory practice.
Using the Urisys 1100 system eliminates factors known to affect visual evaluation of urine test strips, such as:
• Variable lighting conditions at the workplace
• People's individual skill at matching colors and their limits of concentration
• Different reaction times for the test strips
• Clerical errors
• Strong color of the urine sample
The following symbols are used throughout this document.
Symbols/Signs Explanation
WARNING/CAUTION: Indicates a potentially hazardous situation that if not avoided
could result in personal injury or damage to the instrument. This symbol is also used to
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highlight situations that can compromise results.
BIOHAZARD: Indicates a potentially dangerous situation involving the presence of
biohazardous material. All safety precautions must be taken to prevent personal injury
or damage to the equipment.
ATTENTION: Indicates special problems or important information. Read the
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accompanying text carefully.
* Combur Test and Combur Test urine test strips are not available in all countries.
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Revision date
June 2008
Gebrauchsanweisung V04 / Operator's Manual V04 / Manual de instrucciones V04
Amendments
Operator ID, limited lock-out function,Device ID,
compatibility of barcode reader, ASTM protocol
Test UX,
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