Instruction for use URYXXON
®
500
6
Instruction for use URYXXON
®
500 V 2.1 / 01.23
1. Introduction
This instruction for use is provided for the URYXXON
®
500 models
REF 930080 and 930080.XXX.
The URYXXON
®
500 is a reflection photometer for the semi‑
quantitative evaluation of URYXXON
®
Stick 10 urine test strips.
Measured values may be displayed, printed and transferred to a
computer. The URYXXON
®
500 is designed for
in vitro
diagnostic
use (IVD) and should be used by healthcare professionals, only.
Equipped with a touch screen and intuitive user guidance, the
URYXXON
®
500 assures a quick, efficient and convenient work
flow. Therefore, the URYXXON
®
500 is the ideal instrument for
modern urine analysis.
1.1 Intended Purpose
The URYXXON
®
500 is a reflection photometer for the evaluation
of urine test strips. The URYXXON
®
500 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
®
500 is intended for use
by professional users. The URYXXON
®
500 enables integration
into laboratory information and management systems (LIMS) and
supports bidirectional data transfer (from / to the device).
1.2 Intended user
The URYXXON
®
500 is intended for use by trained professionals
with experience in human urine sampling and is not suitable for
self‑testing.
1.3 Indications for use
For indication regarding the indications for use refer to the
instructions for use of the used urine test strips.
1.4 Patient population
There are no restrictions regarding the patient population with
MACHEREY‑NAGEL urine test strips.
1.5 System description
1.5.1 Measuring principle
The test strip is placed on a transport tray rack and is moved below
a movable measuring head by the transport rack.
The strip is illuminated with four LED and a detector registers
the intensity of light reflected by the test strip. Using an internal
calibration, the intensity of the reflected light is correlated to the
concentration of the analyte. By comparing the remission values
with a range table (so‑called cut‑off limits) the measurement result
is determined. Whenever samples are strongly alkaline, a density
correction is automatically conducted.
1.5.2 Functional principle URYXXON
®
500
A measurement is started by placing a strip on the transport rack.
If the Autostart‑feature is turned off, the measurement is started
by pressing the start panel in the display. The result is shown,
stored in the memory, printed out and released via the interfaces
after the measurement has been completed. After ten minutes the
instrument will go into stand‑by. Touching the screen will reactivate
the instrument. All user inputs are performed via the touch‑screen
(see chapter 6. Operation and user guidance, page 14)
1.6 Product labeling
Exemplary name plate on the device
MACHEREY-NAGEL GmbH & Co. KG
Valencienner Str. 11 · 52355 Düren · Germany
Tel.: +49 24 21 969-0 · [email protected] ·
www.mn-net.com
1
URYXXON
®
500
930080
Rev. 01.2022
Refl ektionsphotometer / Refl ection photometer
Réfl ectromètre / Refl ectrometro für / for / pour / para
Medi-Test URYXXON
®
Stick 10
Exemplary sticker on the box
