Macherey-Nagel URYXXON 500 User manual

Rapid Tests
MACHEREY‑NAGEL
URYXXON®500
User Manual
en de
it
ro
www.mn‑net.com
www.mn‑net.com
DE Tel.: [phone]‑0 info@mn‑net.com
CH Tel.: [phone] sales‑ch@mn‑net.com
FR Tel.: [phone] sales‑fr@mn‑net.com
US Tel.: [phone] sales‑us@mn‑net.com
MACHEREY‑NAGEL GmbH & Co. KG
Valencienner Str. 11
52355 Düren · Deutschland
www.mn‑net.com
www.mn‑net.com
DE Tel.: [phone]‑0 info@mn‑net.com
CH Tel.: [phone] sales‑ch@mn‑net.com
FR Tel.: [phone] sales‑fr@mn‑net.com
US Tel.: [phone] sales‑us@mn‑net.com
MACHEREY‑NAGEL GmbH & Co. KG
Valencienner Str. 11
52355 Düren · Deutschland

Contents
Instruction for use (EN) ………………………………………………………………………………………………………………… 3
Gebrauchsanweisung (DE) …………………………………………………………………………………………………………… 35
Istruzioni per l’uso (IT) ………………………………………………………………………………………………………………… 69
Instrucțiuni de utilizare (RO) ……………………………………………………………………………………………………… 101

Rapid Tests
MACHEREY‑NAGEL
Reflection photometer
URYXXON®500
www.mn‑net.com
www.mn‑net.com
DE Tel.: [phone]‑0 info@mn‑net.com
CH Tel.: [phone] sales‑ch@mn‑net.com
FR Tel.: [phone] sales‑fr@mn‑net.com
US Tel.: [phone] sales‑us@mn‑net.com
MACHEREY‑NAGEL GmbH & Co. KG
Valencienner Str. 11
52355 Düren · Deutschland
www.mn‑net.com
www.mn‑net.com
DE Tel.: [phone]‑0 info@mn‑net.com
CH Tel.: [phone] sales‑ch@mn‑net.com
FR Tel.: [phone] sales‑fr@mn‑net.com
US Tel.: [phone] sales‑us@mn‑net.com
MACHEREY‑NAGEL GmbH & Co. KG
Valencienner Str. 11
52355 Düren · Deutschland
Instruction for use

Instruction for use URYXXON®500
4Instruction for use URYXXON®500 V 2.1 /01.23
1. Introduction …………………………………………………………………………………………………………………………… 6
1.1 Intended Purpose ………………………………………………………………………………………………………………………………… 6
1.2 Intended user ……………………………………………………………………………………………………………………………………… 6
1.3 Indications for use ………………………………………………………………………………………………………………………………… 6
1.4 Patient population ………………………………………………………………………………………………………………………………… 6
1.5 System description ………………………………………………………………………………………………………………………………… 6
1.5.1 Measuring principle …………………………………………………………………………………………………………………………… 6
1.5.2 Functional principle URYXXON®500 ………………………………………………………………………………………………………… 6
1.6 Product labeling …………………………………………………………………………………………………………………………………… 6
1.7 Technical data ……………………………………………………………………………………………………………………………………… 7
1.8 Symbols …………………………………………………………………………………………………………………………………………… 8
2. Safety precautions …………………………………………………………………………………………………………………… 9
2.1 Power supply ……………………………………………………………………………………………………………………………………… 9
2.2 Biohazard …………………………………………………………………………………………………………………………………………… 9
2.3 Protective clothing ………………………………………………………………………………………………………………………………… 9
2.4 Inappropriate application ………………………………………………………………………………………………………………………… 9
2.5 Housing damage …………………………………………………………………………………………………………………………………… 9
2.6 Cable break ………………………………………………………………………………………………………………………………………… 9
2.7 Transport …………………………………………………………………………………………………………………………………………… 9
3. Instrument set-up ………………………………………………………………………………………………………………… 10
3.1 Package content ………………………………………………………………………………………………………………………………… 10
3.2 Set‑up location ………………………………………………………………………………………………………………………………… 10
4. Initial operation …………………………………………………………………………………………………………………… 11
4.1 Insert the transport rack ………………………………………………………………………………………………………………………… 11
4.2 Power supply …………………………………………………………………………………………………………………………………… 11
4.3 Connections / interface ………………………………………………………………………………………………………………………… 12
4.4 Insert printer paper ……………………………………………………………………………………………………………………………… 12
4.5 Switching on the instrument …………………………………………………………………………………………………………………… 12
4.6 Calibration ……………………………………………………………………………………………………………………………………… 13
4.7 Switching o the device ………………………………………………………………………………………………………………………… 13
5. Quick start ………………………………………………………………………………………………………………………… 13
6. Operation and user guidance …………………………………………………………………………………………………… 14
6.1 Touch screen …………………………………………………………………………………………………………………………………… 14
6.2 Operating the user interface …………………………………………………………………………………………………………………… 14
6.2.1 Activity‑buttons ……………………………………………………………………………………………………………………………… 14
6.2.2 Option‑fields ………………………………………………………………………………………………………………………………… 14
6.2.3 Edit‑buttons ………………………………………………………………………………………………………………………………… 14
6.2.4 Input‑menu ………………………………………………………………………………………………………………………………… 14
6.3 Stand‑by mode ………………………………………………………………………………………………………………………………… 14
7. Main menu ………………………………………………………………………………………………………………………… 15
8. Settings …………………………………………………………………………………………………………………………… 15
8.1 Strip ……………………………………………………………………………………………………………………………………………… 15
8.1.1 Units ………………………………………………………………………………………………………………………………………… 15
8.1.2 Customized order …………………………………………………………………………………………………………………………… 15
8.2 Interface ………………………………………………………………………………………………………………………………………… 16
8.2.1 HW settings ………………………………………………………………………………………………………………………………… 16
8.2.1.1 Baud rate ………………………………………………………………………………………………………………………………… 16
8.2.1.2 Bit length ………………………………………………………………………………………………………………………………… 16
8.2.1.3 Parity ……………………………………………………………………………………………………………………………………… 16
8.3 Printer …………………………………………………………………………………………………………………………………………… 16
8.4 Sediment options ……………………………………………………………………………………………………………………………… 17
8.4.1 Enter sediment ……………………………………………………………………………………………………………………………… 17
8.4.1.1 Edit sediment parameters ……………………………………………………………………………………………………………… 17
8.4.2 Filter ………………………………………………………………………………………………………………………………………… 17
8.4.2.1 Edit filter ……………………………………………………………………………………………………………………………………… 17
8.4.3 Print after ……………………………………………………………………………………………………………………………………… 18
8.4.4 Print sediment settings ……………………………………………………………………………………………………………………… 18
8.5 Language ………………………………………………………………………………………………………………………………………… 18
8.6 Date / Time ……………………………………………………………………………………………………………………………………… 18
8.7 User mode ……………………………………………………………………………………………………………………………………… 18
8.7.1 Single user …………………………………………………………………………………………………………………………………… 19
8.7.2 User / Admin ………………………………………………………………………………………………………………………………… 19
8.7.3 Multi user …………………………………………………………………………………………………………………………………… 19
8.7.3.1 Edit users ………………………………………………………………………………………………………………………………… 19
8.8 Customization …………………………………………………………………………………………………………………………………… 20
8.8.1 Clarity ………………………………………………………………………………………………………………………………………… 20
8.8.2 Color ………………………………………………………………………………………………………………………………………… 20
8.8.3 Welcome line ………………………………………………………………………………………………………………………………… 20
8.8.4 Printer header ……………………………………………………………………………………………………………………………… 20

Instruction for use URYXXON®500
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Instruction for use URYXXON®500 V 2.1 / 01.23
8.9 Sound …………………………………………………………………………………………………………………………………………… 20
8.10 Print settings …………………………………………………………………………………………………………………………………… 20
8.11 Autostart ……………………………………………………………………………………………………………………………………… 20
9. Enter sediment …………………………………………………………………………………………………………………… 21
9.1 Microscope ……………………………………………………………………………………………………………………………………… 21
9.2 Print ……………………………………………………………………………………………………………………………………………… 22
9.3 Send to a PC …………………………………………………………………………………………………………………………………… 22
10. Memory …………………………………………………………………………………………………………………………… 22
10.1 Show all ………………………………………………………………………………………………………………………………………… 22
10.1.1 Print ………………………………………………………………………………………………………………………………………… 22
10.1.2 Send to a PC ……………………………………………………………………………………………………………………………… 22
10.1.3 Microscope ………………………………………………………………………………………………………………………………… 22
10.2 Search ………………………………………………………………………………………………………………………………………… 23
10.2.1 Date ………………………………………………………………………………………………………………………………………… 23
10.2.2 Filter ………………………………………………………………………………………………………………………………………… 23
10.2.3 Action ……………………………………………………………………………………………………………………………………… 24
11. Check mode ……………………………………………………………………………………………………………………… 24
11.1 Internal check ………………………………………………………………………………………………………………………………… 24
11.2 Control measurement ………………………………………………………………………………………………………………………… 24
11.3 Control strip …………………………………………………………………………………………………………………………………… 24
11.4 Stored data …………………………………………………………………………………………………………………………………… 24
12. General information for measurements ……………………………………………………………………………………… 25
12.1 Urine sample …………………………………………………………………………………………………………………………………… 25
12.2 Test strip preparation ………………………………………………………………………………………………………………………… 25
13. Measurement …………………………………………………………………………………………………………………… 25
13.1 Sample and patient information ……………………………………………………………………………………………………………… 25
13.2 Single measurement …………………………………………………………………………………………………………………………… 26
13.3 Successive measurements …………………………………………………………………………………………………………………… 26
13.4 Measurements with worklist ………………………………………………………………………………………………………………… 26
13.4.1 Create a worklist …………………………………………………………………………………………………………………………… 26
13.4.2 Edit worklist ………………………………………………………………………………………………………………………………… 27
13.4.3 Measuring with the worklist ……………………………………………………………………………………………………………… 27
13.4.4 Options …………………………………………………………………………………………………………………………………… 27
13.4.4.1 Load list ………………………………………………………………………………………………………………………………… 27
13.4.4.2 Print list ………………………………………………………………………………………………………………………………… 27
13.4.4.3 Delete list ……………………………………………………………………………………………………………………………… 27
13.4.5 Emergency measurement ………………………………………………………………………………………………………………… 27
14. Quality control …………………………………………………………………………………………………………………… 28
14.1 Check mode …………………………………………………………………………………………………………………………………… 28
14.1.1 Internal check ……………………………………………………………………………………………………………………………… 28
14.1.2 Control measurement ……………………………………………………………………………………………………………………… 28
14.1.3 Control strip measurement ……………………………………………………………………………………………………………… 28
14.1.4 Stored data ………………………………………………………………………………………………………………………………… 28
15. Connection of external devices ………………………………………………………………………………………………… 29
15.1 Computer ……………………………………………………………………………………………………………………………………… 29
15.2 Barcode reader / Keyboard …………………………………………………………………………………………………………………… 29
15.3 Connection to a LIS …………………………………………………………………………………………………………………………… 29
16. Cleaning and maintenance ……………………………………………………………………………………………………… 29
16.1 Daily cleaning ………………………………………………………………………………………………………………………………… 29
16.2 Weekly cleaning ……………………………………………………………………………………………………………………………… 29
17. Service …………………………………………………………………………………………………………………………… 30
17.1 Spare parts and accessories ………………………………………………………………………………………………………………… 30
17.2 Consumables ………………………………………………………………………………………………………………………………… 30
17.3 Error messages ………………………………………………………………………………………………………………………………… 30
17.4 Disposal ………………………………………………………………………………………………………………………………………… 31
17.5 Analytical Performance Characteristics ……………………………………………………………………………………………………… 31
17.5.1 Table of results …………………………………………………………………………………………………………………………… 31
17.5.2 Precision …………………………………………………………………………………………………………………………………… 31
17.5.3 Assay reportable range …………………………………………………………………………………………………………………… 32
17.5.4 Cut‑o concentration ……………………………………………………………………………………………………………………… 32
17.6 Changing the cut‑o points …………………………………………………………………………………………………………………… 32
17.7 Comparative study …………………………………………………………………………………………………………………………… 32
17.8 Interference study ……………………………………………………………………………………………………………………………… 33
17.9 Warranty ………………………………………………………………………………………………………………………………………… 33
17.10 General usage comments …………………………………………………………………………………………………………………… 33
17.11 Literature ……………………………………………………………………………………………………………………………………… 33
17.12 CE Certification ……………………………………………………………………………………………………………………………… 34
17.13 Contact ……………………………………………………………………………………………………………………………………… 34
17.14 Version History ……………………………………………………………………………………………………………………………… 34

Instruction for use URYXXON®500
6Instruction 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, ecient 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‑o 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 o, 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.: [phone] · [email protected] · www.mn-net.com
1
URYXXON®500
930080
Rev. 01.2022
Reflektionsphotometer / Reflection photometer
Réflectromètre / Reflectrometro für / for / pour / para
Medi-Test URYXXON®Stick 10
Exemplary sticker on the box

Instruction for use URYXXON®500
7
Instruction for use URYXXON®500 V 2.1 / 01.23
1.7 Technical data
General info Size 24 cm x 28 cm x 15 cm (9.5“ x 11“ x 5.9“)
Weight 3.9 kg (10.5 lb)
Measurements/h 350
Power supply External power pack 100 – 250 V (Type SM‑075 A0F‑11), Input 47 – 63 Hz, Output 7.5 V 5,34 A or GST40A07 /
Globtek Inc GTM96600‑4507.5T3.
Transport condition ‑10 °C – 45 °C, max. 80 % humidity (non‑condensing)
Operation condition 4 – 30 °C, max. 80 % humidity (non‑condensing), max. 2000 m
Storage condition 4 – 30 °C , max. 80 % humidity (non‑condensing)
Measurement Principal Reflection photometer
Light source 4 LEDs, wave length: 470, 550, 610, 910 nm
Detector Photodiode
User Interface Touch screen W x H = 10 x 7.5 cm
Color display
Resolution 320 x 240 Pixel
User menu Settings and user guidance in 8 languages
Printer Thermo transfer
Interface 1 x USB
2 x RS232 9600 Baud, 8, N, 1 uni‑/bidirectional mode (base setting)
1 x PS/2 Keyboard / barcode scanner
Memory Capacity 500 measurements
20 control measurements
Accessories
(optional)
Keyboard Data input
Barcode scanner Data input
Serial cable PC connection
Protection class Equipment:
Power Supply:
Protection Class III
Protection Class I
Overvoltage category Equipment:
Power supply:
Category II
Category I
Degree of pollution 2

Instruction for use URYXXON®500
8Instruction for use URYXXON®500 V 2.1 /01.23
1.8 Symbols
The following table explains the symbols that are used on the
device, the power supply, the package as well as the instruction
for use. For the explanation of the symbols used on the strips and
control solutions, refer to the respective instructions for use.
Caution
Non‑sterile
Keep away from sunlight
Biological risc
Keep dry
Temperature limits
Do not use if package is damaged and consult instructions for use
Consult instructions for use or consult electronic instructions for use
Do not dispose of the device in common household waste.
Manufacturer
Catalogue number
Batch code
Serial Number
Date of Manufacture
Use‑by date
In vitro diagnostic medical device
CE Mark
Direct current
Do not reuse
Device for near patient testing
Device not for self testing
Contains <n> tests

Instruction for use URYXXON®500
9
Instruction for use URYXXON®500 V 2.1 / 01.23
2. Safety precautions
BE SURE TO READ THE FOLLOWING SAFETY INSTRUCTIONS
CAREFULLY BEFORE USING THE DEVICE.
Failure to follow these instructions may result in serious injury to the
operator, malfunction or damage to the equipment.
Keep this operating instruction in a safe place for future reference.
Follow the safety notes and instructions in the operating instruction
and observe the stickers and notices on the device.
Do not work on internal parts of the unit. Non‑compliance will
invalidate any warranty claim.
Use of the hazard warnings:
DANGER
Indicates an imminent or potentially hazardous situation which, if
not avoided, will result in death or serious injury.
WARNING
Indicates an imminent or potentially hazardous situation which, if
not avoided, could result in death or serious injury.
CAUTION
Indicates a potentially hazardous situation which, if not avoided,
may result in minor or moderate injury.
NOTICE
Indicates a situation which, if not avoided, may result in
malfunction or damage of the instrument. Information that
clarifies facts in the text and that requires special attention.
2.1 Power supply
To ensure safe functioning of the instrument, only use the included
power pack!
WARNING
Risk of electric shock. Only use the included power
supply Type SM‑075 A0F‑11. Use of other power
supplies can damage the device and harm the user.
WARNING
Only use the device with protective grounding.
2.2 Biohazard
Using the instrument makes contact to urine inevitable.
Therefore, use protective gloves whenever measuring with the
instrument and be cautious when handling urine samples.
CAUTION
Biological Hazard: Urine residues
Urine and used test strips pose a risk of infection. Always
wear protective gloves when handling and disposal.
Dispose of used test strips according to the regulations
for handling potentially infectious material.
2.3 Protective clothing
We recommend to always wear gloves and a lab coat as protective
clothing.
2.4 Inappropriate application
The URYXXON®500 is designed for the professional evaluation
of URYXXON®Stick 10 urine test strips. Inappropriate use, or use
by untrained sta terminates any warranty claim for the user with
respect to MACHEREY‑NAGEL.
2.5 Housing damage
If the housing is damaged, the instrument has to be sent in for repair.
Correct functioning and measuring results are not guaranteed any
more.
2.6 Cable break
In the case of cable break, immediately stop using the instrument
and replace the power pack.
WARNING
Risk of electric shock. Cable break can lead to exposure
to conduction cables. Stop using the device immediately
and remove the power supply from the outlet if possible.
2.7 Transport
To transport the instrument, the cardboard box from the initial
shipment including the protective foamed plastic is ideal. Therefore,
we recommend to keep the box. In case you do not have the
original box anymore, use a large cardboard box and plenty of
soft cushioning material, so that the instrument cannot shift during
transport.
Make sure to remove the transport rack before you ship the
instrument.

Instruction for use URYXXON®500
10 Instruction for use URYXXON®500 V 2.1 /01.23
3. Instrument set-up
3.1 Package content
Open the box carefully with a sharp instrument. Make sure not to
damage the content. Take out the instrument and all other parts
carefully. Check the package, instrument and all accessories for
visible damage. If a part is damaged, contact your distributor or the
technical support (see chapter 17.13 Contact, page 34).
The following picture shows the complete package content. Check
the shipment for completeness. If a part is missing, contact your
distributor or the technical support as well.
NOTICE
Keep the original box and the packaging material from the initial
shipment to optimally protect the instrument in case of a return
shipment.
3.2 Set-up location
Only use the instrument in a suitable location. It should be
positioned on a dry, clean, level and horizontal surface.
The operating temperature is between 4 – 30 °C, while the optimal
temperature range for the instrument is between 18 – 25 °C. For
optimal performance, the humidity should be between 20 – 80 %.
The instrument must not be used above 2000 m.
Make sure to protect the instrument from drastic changes in
temperature. Avoid positioning the instrument close to windows,
hot plates, ovens etc. To ensure correct functioning and reliable
results, the instrument should not be exposed to direct sunlight or
other bright, focused light sources.
NOTICE
When operating outside these limits, the correct functioning of
the device is not guaranteed.
aURYXXON®500 bTransport rack cThermal printer paper rolls
dInstruction for use eSerial cable RS232 fPower cable gPower adapter