Introduction; Intended Use; Intended User; Indications For Use - MACHEREY-NAGEL URYXXON Relax Mode D'emploi

2. Introduction

This instruction for use is provided for the URYXXON Relax model REF 93088 and 93088.
®
XXXXXX.
The URYXXON Relax is a portable and easy to use urine analyzer for professional use. It
®
is an in-vitro diagnostic device designed to read test strips for urine analysis produced by
MACHEREY-NAGEL only. The URYXXON Relax provides semi-quantitative values, which
®
may be displayed, printed and transferred. The tests performed with the URYXXON Relax are
®
intended for in-vitro diagnostic use only.

2.1 Intended Use

The URYXXON Relax is a portable reflection photometer for the evaluation of urine test strips.
®
The URYXXON Relax is intended for use with compatible test strips from MACHEREY-NAGEL.
®
The in-vitro analysis system is an aid to diagnoses in the areas of kidney function, urinary tract
infections, metabolic diseases (e.g. diabetes mellitus) and liver function. The URYXXON Relax
®
is intended for use by professionals. The URYXXON Relax enables integration into laboratory
®
information and management systems (LIMS).

2.2 Intended User

The URYXXON Relax is intended for use by trained professionals with experience in human
®
urine sampling and is not suitable for self-testing.

2.3 Indications for use

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

2.4 Patient population

There are no restrictions regarding the patient population with MACHEREY-NAGEL urine test
strips.

2.5 Type of specimen

Testing of fresh, native, well-mixed and non-centrifuged urine is recommended. Samples
should be protected from light. Only urine samples which have stood for a maximum of 4
hours should be used.
Manual URYXXON Relax EN, V 6.01 / 03.22
® 67