Arkray AUTION ELEVEN AE-4022, Руководство по эксплуатации

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AE-4022
v
3 PREMISE
Intended Use
The AUTION ELEVEN Semi-Automated Urinalysis System provides qualitative and semi-quantitative
measurements for glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrites, leukocytes, specific
gravity and color tone in urine specimens. The system is intended for in vitro diagnostic use in screening
patient populations found in clinical laboratories.
The AUTION ELEVEN Semi-Automated Urinalysis System consists of the following:
 AUTION ELEVEN model AE-4022 Urine Analyzer (device component)
 AUTION Sticks 10EA Test Strips (reagent component)
Product Description
The AUTION Sticks 10EA consist of a plastic strip containing 10 pads impregnated with chemicals specific
for the determination of a particular analyte. The chemical reaction with the urine results in a color change
and indicates the concentration of the analyte.
The AUTION ELEVEN AE-4022 technology provides fast results that can be used along with other
diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.
There are substances that may interfere with the chemical reagent on the pads or the urine analyte such
that the result should be double-checked or another means of analysis should be used against the AUTION
ELEVEN AE-4022 results. These interfering substances are further explained on the AUTION Sticks 10EA
package insert.
The AUTION ELEVEN AE-4022 also provides a feature to manually enter the clarity (general transparency
or cloudiness caused by particulates in the specimen), as a useful observance, although it is not measured
by the instrument.