Urisys - Operator’s Manual V.
. Introduction
Revision History
Manual version Software version Revision date Amendments
. .x June Operator ID, limited lock-out function,Device ID,
compatibility of barcode reader, ASTM protocol
. .x - Cobas brand
. .x -
New material numbers
Changed test strip handling
Remove of the intended use of Combur
Test and
Combur
Test on Urisys .
. > = . - Combur
and Combur
removed from software flow
chart.
. > = . - Quality control (QC) section added.
Test strip tray lifetime added.
Cleaning and maintenance section improved.
Paragraph “Values obtained are implausible when
compared with those from visual evaluation” revised in
section “Error messages and troubleshooting”.
Paragraph „Control values fall outside the designated
ranges“ added in section “Error messages and
troubleshooting”.
The Urisys system is a reflectance photometer designed to read and evaluate the urine test strips Combur
Test
®
UX
from Roche Diagnostics. It reads the strips under standard ized conditions, saves the results to memory and outputs them
via its own inbuilt printer and/or serial interface.
COBAS, LIFE NEEDS ANSWERS, URISYS, URISYS , COMBUR-TEST, CHEMSTRIP and REFLOTRON are trademarks
ofRoche.
Combur
Test
®
UX test strips are marketed in Canada as Chemstrip A test strips.
The Urisys 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 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
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
accompanying text carefully.