Introduction; Intended Use; Intended User; Indications For Use - MACHEREY-NAGEL URYXXON Relax Manual De Instrucciones

2. Introduction

This instruction for use is provided for the URYXXON
and 93088.XXXXXX.
®
The URYXXON Relax is a reflection photometer for the analysis of urine test
strips. The measurements are performed under standardized conditions, mea-
sured values may be displayed, printed and transferred to a computer.
®
The URYXXON Relax is designed for in-vitro diagnostic use (IVD) and should
be used by healthcare professionals, only. Discuss each positive result with a
doctor. In case of persisting symptoms repeat measurement.

2.1. Intended Use

®
The URYXXON Relax is a portable reflectance photometer that instrumentally
measures the reflectance of a reacted Medi-Test reagent strip for Urinalysis.
®
The URYXXON Relax is intended to be used with compatible test strips from
MACHEREY-NAGEL.
®
The URYXXON Relax is intended for use as an in vitro diagnostic aid using
urine specimens for screening for diabetes, metabolic abnormalities, liver dis-
eases, biliary and hepatic obstructions and diseases of kidney and urinary tract.

2.2. Intended User

®
The URYXXON Relax is intended for use by trained professionals with experi-
ence in human urine sampling.

2.3. Indications for use

For indication regarding the indications for use refer to the instructions for use
of the used strips.

2.4. Testing population

For information regarding the testing population refer to the instructions for use
of the used strips.

2.5. System description

2.5.1. Measuring principle

The test strip moves below a fixed measuring head on a sled with an embedded
reference pad. The reflectometric analysis of the test strip and the reference
field take place during withdrawal and release of the sled.
Manual URYXXON
Manual URYXXON
®
Relax EN, V6.00 / 11.20
®
Relax
®
Relax model REF 93088
67