Henry Schein Urispec Plus - Introduction and Intended Use; Intended Use and Indications; Measuring Principle Explained; Functional Principle of Urispec Plus

User manual Urispec
®
Plus
7
Manual Urispec
®
Plus V2.01 HS USA / 04-19
2. Introduction and intended use
The Urispec
®
Plus is a reection photometer for the analysis of Urispec
®
urine
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
®
urine test strips for the determination of specic
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 xed measuring head on a slide with an embed-
ded reference pad. The reectometric analysis of the test strip and the reference
eld take place during withdrawal and release of the slide.
Pic. 1: Measuring Principle
The strip is illuminated with an LED and a detector registers the intensity of light
reected by the test strip at three different wavelengths. Using an internal cali-
bration, the results are calculated from the reection values. Whenever samples
are strongly alkaline, a density correction is automatically conducted.
2.1.2. Functional Principle Urispec
®
Plus
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