Introduction; Intended Use; Intended User; Indications For Use - Macherey-Nagel URYXXON Relax User Manual

Manual URYXXON

2. Introduction

This instruction for use is provided for the URYXXON
930880.XXXXXX.
®
The URYXXON Relax is a portable and easy to use urine analyzer for pro-
fessional use. It is designed to read test strips for urine analysis produced by
MACHEREY-NAGEL only. The URYXXON
values, which may be displayed, printed and transferred. The connect options of
®
the URYXXON Relax are a software enhancement that can be activated via the
settings of the instrument and allow for integration into laboratory information
and management systems (LIMS). 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 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 for screen-
ing in urine specimen for the detection of diabetes, metabolic abnormalities, liver
diseases, biliary and hepatic obstructions, hemolytic diseases and diseases of
kidney and urinary tract.
®
The URYXXON Relax system allows for instrument integration into laboratory
information and management systems (LIMS) and provides bidirectional data
transfer (from/to the instrument). The URYXXON
tended to be used for near-patient testing.

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 indication regarding the testing population refer to the instructions for use of
the used strips.
10
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Relax
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Manual URYXXON
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Relax model 930880 and
Relax provides semi-quantitative
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Relax instrument is not in-
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Relax EN, V 5.00C / 06.19
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