Introduction And Intended Use; Intended Use And Indications For Use; Measuring Principle; Functional Principle Urispec - Henry Schein Urispec Plus User Manual

2. Introduction and intended use
The Urispec ® Plus is a reflection photometer for the analysis of Urispec
test strips. The measurements are performed under standardized conditions,
measured values may be displayed, printed and transferred to a computer.
The Urispec ® Plus is designed for in-vitro diagnostic use (IVD) and should be
used by healthcare professionals, only.
2.1. Intended Use and Indications for Use
The Urispec ® Plus is intended for use as an in vitro diagnostic aid using urine
specimens for screening for diabetis metabolic abnormalities, liver diseases,
biliary and hepatic obstructions of the kidneys and urinary tract.
The test provided on Urispec
gravity, leucocytes, glucose, protein, blood, nitrite, pH, ketones, bilirubin, ascor-
bic acid and urobilinogen are considered routine urinalysis.
2.1.1. Measuring Principle
The test strip moves below a fixed measuring head on a slide with an embed-
ded reference pad. The reflectometric analysis of the test strip and the reference
field take place during withdrawal and release of the slide.
The strip is illuminated with an LED and a detector registers the intensity of light
reflected by the test strip at three different wavelengths. Using an internal cali-
bration, the results are calculated from the reflection values. Whenever samples
are strongly alkaline, a density correction is automatically conducted.
2.1.2. Functional Principle Urispec
A measurement is started by placing a strip on the holder. If the Autostart-fea-
ture is turned off, the measurement is started by pressing the start panel
Manual Urispec
User manual Urispec
urine test strips for the determination of specific
®
Pic. 1: Measuring Principle

Plus

®
Plus V2.01 HS USA / 04-19
®
Plus
®
® urine
7