Macherey-Nagel URYXXON Relax User manual

Wasseranalytik
MACHEREY-NAGEL
URYXXON®Relax
MACHEREY-NAGEL GmbH & Co. KG · Neumann-Neander-Str. 6–8 · 52355 Düren · Deutschland
www.mn-net.com
www.mn-net.com
DE / International:
Tel.: [phone]
Fax: [phone]
E-Mail: [email protected]
CH:
Tel.: [phone]
Fax: [phone]
E-Mail: [email protected]
FR:
Tel.: [phone]
Fax: [phone]
E-Mail: [email protected]
ISO 9001
ZERTIFIZIERT
MACHEREY-NAGEL GmbH & Co. KG · Neumann-Neander-Str. 6–8 · 52355 Düren · Deutschland
www.mn-net.com
www.mn-net.com
DE / International:
Tel.: [phone]
Fax: [phone]
E-Mail: [email protected]
CH:
Tel.: [phone]
Fax: [phone]
E-Mail: [email protected]
FR:
Tel.: [phone]
Fax: [phone]
E-Mail: [email protected]
ISO 9001
ZERTIFIZIERT
User manual
Medi-Test

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1. Quickstart ……………………………………………………………………… 64
2. Introduction……………………………………………………………………… 67
2.1. Intended Use ……………………………………………………………… 67
2.2. Intended User ……………………………………………………………… 67
2.3. Indications for use ………………………………………………………… 67
2.4. Testing population ………………………………………………………… 67
2.5. System description ………………………………………………………… 67
2.5.1. Measuring principle ……………………………………………………… 67
2.5.2. Functional principle URYXXON®Relax………………………………… 68
3. Unpacking and set up ………………………………………………………… 71
3.1. List of delivered parts ……………………………………………………… 71
3.2. Consumables ……………………………………………………………… 71
3.3. Note on ambient surrounding……………………………………………… 71
3.4. Setting up the instrument ………………………………………………… 72
3.5. Description of instrument parts …………………………………………… 72
3.6. How to plug the instrument in …………………………………………… 73
3.7. How to load the printer paper……………………………………………… 73
3.8. How to install batteries (optional) ………………………………………… 74
3.9. Instrument self test ………………………………………………………… 74
3.10. Calibration ………………………………………………………………… 74
3.11. Use of the instrument …………………………………………………… 75
3.11.1. Buttons …………………………………………………………………… 75
3.11.2. Scroll Menu ……………………………………………………………… 75
3.11.3. Round buttons…………………………………………………………… 75
4. User menu ……………………………………………………………………… 77
4.1. Flow-chart of the menu structure ………………………………………… 77
4.2. Description of the menu items …………………………………………… 78
5. Analysis of test strips ………………………………………………………… 79
5.1. How to perform a measurement ………………………………………… 79
5.2. Display of results …………………………………………………………… 80
5.3. Measurement errors ……………………………………………………… 81
5.4. Entering the patient identification ………………………………………… 81
5.5. Changing the sequence number ("SN") ………………………………… 82
5.6. Transferring data to a PC ………………………………………………… 82
6. Enter the main menu…………………………………………………………… 83
7. Recall results …………………………………………………………………… 84
7.1. How to scroll through memory …………………………………………… 84
7.2. How to find specific results (filtering) …………………………………… 85
7.2.1. Selecting the date………………………………………………………… 85
7.2.2. Selecting search criteria ………………………………………………… 86
7.2.3. Display suitable matches………………………………………………… 86
7.3. How to delete results from memory ……………………………………… 87

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8. Quality control testing ………………………………………………………… 88
8.1. How to review old QC measurements …………………………………… 88
8.2. How to perform a QC measurement ……………………………………… 89
9. Equipment Settings …………………………………………………………… 90
9.1. How to modify strip settings ……………………………………………… 90
9.1.1. Type………………………………………………………………………… 90
9.1.2. Units ……………………………………………………………………… 90
9.1.3. Order of Parameters……………………………………………………… 90
9.1.4. Test Strip LOT …………………………………………………………… 91
9.2. How to protect settings from unauthorized access……………………… 91
9.3. How to turn the printer on and off ………………………………………… 91
9.4. How to enable and disable acoustic signals …………………………… 91
9.4.1. Acoustic confirmation of user inputs …………………………………… 91
9.4.2. Acoustic warning on positive results …………………………………… 91
9.5. How to deactivate and activate the autostart …………………………… 92
9.6. How to set energy saving options for the battery mode………………… 92
9.7. How to change the language ……………………………………………… 92
9.8. How to set time and date ………………………………………………… 93
9.9. How to activate data transfer ……………………………………………… 94
9.10. How to change the text of the printout header ………………………… 94
9.11. How to print the settings ………………………………………………… 94
10. Cleaning and maintenance ………………………………………………… 95
10.1. How to clean the housing ………………………………………………… 95
10.2. How to clean the strip holder …………………………………………… 96
11. Service menu ………………………………………………………………… 97
11.1. How to reset the system (Load Default)………………………………… 97
11.2. How to control the LOT-control (LOT activate) ………………………… 97
11.2.1. Entry of test strips’ LOT ………………………………………………… 98
11.2.2. Warning on expired test strips ………………………………………… 99
11.3. How to change the sensitivity ………………………………………… 100
11.3.1. Settings Reset………………………………………………………… 100
11.3.2. Appointing new Sensitivity Settings………………………………… 100
11.3.3. Reported value – (original threshold) – modification …………… 101
11.4. How to update the instrument ………………………………………… 102
11.5. Control strip …………………………………………………………… 102
12. Interface description ……………………………………………………… 103
12.1. Serial interface ………………………………………………………… 103
12.2. USB 1.1-interface ……………………………………………………… 103
12.3. Transmission protocol ………………………………………………… 103
12.4. Barcode scanner, PC-keyboard ……………………………………… 103
12.5. Ethernet-Interface ……………………………………………………… 103
13. Error Messages and Fault Clearance…………………………………… 104

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14. Warranty ……………………………………………………………………… 105
15. Technical information ……………………………………………………… 106
15.1. Technical data…………………………………………………………… 106
15.2. Security standards……………………………………………………… 106
15.3. Analytical Performance Characteristics ……………………………… 106
15.3.1. Table of results …………………………………………………… 106
15.3.2. Precision …………………………………………………………… 108
15.3.3. Mikroalbumin ……………………………………………………… 109
15.3.4. Linearity …………………………………………………………… 110
15.3.5. Cut-off concentration ……………………………………………… 110
15.4. Electromagnetic Compatibility ………………………………………… 111
15.5. Waste disposal ………………………………………………………… 112
16. Additional Information …………………………………………………… 113
16.1. Manufacturer Information ……………………………………………… 113
16.2. Version history ………………………………………………………… 113

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1. Quickstart
Unpack the instrument and place it on an even, hard surface. Connect the power
supply and turn the equipment on with the On/Off-switch (Pic. 8-). After the
self test the start screen will appear on the display.
0001
1025358
SN:
ID:
(P)
URYXXON STICK 10URYXXON STICK 10
Insert strip!
Display 1: Start menu
• Dip a test strip into the urine sample for approx. one second (Pic. 1).
• Blot by touching the edge of the strip to a paper towel to remove excess urine
(Pic. 2).
Pic. 1: Dip test strip
Pic. 2: Remove excess urine
ATTENTION:
Please make sure to remove access of urine from the test strip to avoid a car-
ryover into the instrument.

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• Place the strip on the strip holder (Pic. 3)
Pic. 3: Correct Pic. 4: Wrong
• Slide or push the strip to the end of the strip holder. Do not touch the reagent
pads on the test strip.
The instrument will automatically detect an applied strip. The measurement cy-
cle will be started. A progress bar on the display shows the remaining measure-
ment time.
NOTE:
If "Autostart" (Chapter 9.5 "How to deactivate and activate the autostart") is
deactivated, the measurement must be started using the start control panel
.
NOTE:
The strip will be drawn into the instrument after 30 sec.

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At the end of the measurement the result will be displayed on the screen and
transferred to the printer and interfaces.
RESULT
Seq.No: 001
ID: 1234567890
15.02.2019 9:47
*BLD 10 ERY/uL
UBG NORM
BIL NEG
PRO NEG
NIT NEG
KET NEG
*GLU 50 mg/dL
pH 5.0
SG 1.000
LEU NEG
Display 2: Result
By pressing the printer symbol the result can be printed again. Choosing
the return panel will lead back to the start screen.
Another analysis may be started by applying the next test strip.
NOTE:
To start a new measurement it is not necessary to go back to the start screen.
A new strip is detected at any time and the measurement is then started
automatically.

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2. Introduction
This instruction for use is provided for the URYXXON®Relax model REF 93088
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.

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Pic. 5: Measuring Principle
The strip is illuminated with an LED and a detector registers the intensity of light
reflected by the test strip at three different wavelengths. Using an internal cali-
bration, the results are calculated from the reflection values. Whenever samples
are strongly alkaline, a density correction is automatically conducted.
2.5.2. Functional principle URYXXON®Relax
A measurement is started by placing a strip on the holder. If the Autostart-feature
is turned off, the measurement is started by pressing the start panel in
the display. The result is shown on the display, printed out and released via the
interfaces after the measurement has been completed. After three minutes the
instrument will go to stand-by. Touching the screen will reactivate the instrument.
All user inputs are performed via the touch-screen (Chapter 3.11 "Use of the
instrument").
2.6. Safety warnings
The following safety warnings are used throughout the manual:
- DANGER: defines a danger which can result in serious injury or death.
- ATTENTION: defines a possible danger which can result in simple - mild injury.
This symbol is also used to indicate user errors which can result in malfunction
or damage to the device.
- NOTE: provides necessary additional information.

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2.7. Labels on the device and the box
MACHEREY-NAGEL GmbH & Co. KG
Neumann-Neander-Str. 6–8 · 52355 Düren · Germany
Tel.: [phone] · [email protected] · www.mn-net.com
1
URYXXON®Relax
93088
Rev.2018-09
Reflektionsphotometer / Reflection photometer
Réflectromètre / Reflectrometro für / for / pour / para
Medi-Test URYXXON®Stick 10
URXXXX
Barcode
DD.MM.YYYY
Examplary carton label
URYXXON® Relax
9 V / 1.5 A
MACHEREY-NAGEL GmbH & Co. KG
Neumann-Neander-Str. 6–8 · 52355 Düren · Germany
Tel.: [phone] · [email protected] · www.mn-net.com
URXXXX
Exemplary type plate label

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2.8. Symbols explanation
Caution: Further information in user manual
The medical device that has not been subjected to a sterilization process.
Keep away from sunlight.
Keep dry.
Temperature limits.
Should not be used if the package is damaged.
The medical device is intended for one use, or for use on a single patient
during asingle procedure.
Indicates the need for the user to consult the instructions for use.
Do not dispose of the device in common household waste.
Medical device manufacturer.
Manufacturer’s catalogue number.
Manufacturer’s batch code.
Serial number of the device.
Date on which the medical device has been manufactured.
Date after which the medical device is not to be used.
In vitro diagnostic device.
Indicates conformity with applicable harmonized standards.
9 V / 1.5A Power input specifications.

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3. Unpacking and set up
3.1. List of delivered parts
URYXXON®Relax reflectometer
Power pack 100 – 240 V, 47/63 Hz, 9 V, incl. adapter
Printer paper
+ User manual (this booklet)
+ Quick guide



Pic. 6: Content
Read the operating manual for URYXXON®Relax carefully before the first start-
up in order to ensure an error free operation.
3.2. Consumables
• Printer paper, pack of five rolls, REF 93065
• Check solution for quality controls, Medi-Test Control, 1 test tube with 15 mL
reagent solution Medi-Test Control N and 1 test tube with 15 mL reagent solu-
tion Medi-Test Control P, REF 93038
• 6 AA type batteries (optional)
3.3. Note on ambient surrounding
If the device is exposed to higher temperature fluctuations (e.g. after transport or
distribution), it must be switched on not before sufficient acclimatization is given.
The device should not be used close to electrical fields (e.g. by microwaves,
radio units et cetera). In worst case the measurement results can be affected.

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3.4. Setting up the instrument
Place the instrument on a hard, even surface where humidity and temperature
are fairly constant. Make sure that the instrument is allowed to acclimate to room
temperature prior to use.
Make sure that you
• Do not place the instrument near strong electromagnetic fields
• Do not place the instrument near heating plates, ovens or radiators
• Do not expose the instrument to strong light sources (i.e. direct sunlight)
3.5. Description of instrument parts



Pic. 7: Front view

d
fe
gi
Pic. 8: Backside view
Actuator Function
1. Touch-Screen Control of equipment functions
2. Test Strip Slide Test strip retainer and autonomous start of analysis
3. Printer Flap Opening the printer flap for paper replacement
4. Serial Interface Connection of a computer (cable length1max. 3 m)
5. USB - Interface Connection of a computer (cable length1max. 3 m)
6. USB - Interface Connection of a keyboard or a bar code scanner2
7. Mains Connection Contact for the provided power pack
8. On/Off Switch (I/O) Turning the equipment on and off
9. LAN-Interface Connection to network (serial over LAN)
1We recommend to use shielded cables.
2We recommend to make use of the hand scanner from MACHEREY-NAGEL
ATTENTION:
Do only connect the intended devices to the corresponding interface. If you
connect another device to the corresponding interface, the analyzer or the
connected device may be damaged. Check all cables prior to use and verify
the proper connection.

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3.6. How to plug the instrument in
Pic. 9: Power pack Pic. 10: DC in
Four adapters are provided for adapting the power pack to the available mains
connection.The sealing protecting the connector pins is removed and the adapt-
er matching the mains connection is plugged on to the power pack (Pic. 9). After
plugging the power pack cable into the jack "DC IN" (Pic. 8-gand connecting
the power pack to the power socket the URYXXON® Relax is ready for operation.
3.7. How to load the printer paper
Pic. 11: Printer A Pic. 12: Printer B
Open the printer flap by pressing the rectangular key next to the printer flap (Pic.
11).

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Pic. 13: Printer C Pic. 14: Printer D
Unroll the paper roll by 5 cm and place the roll in the paper compartment with
the end on the lower side. Fix the end of the paper to the housing with your finger
while closing the flap (Pic. 13 + Pic. 14).
3.8. How to install batteries (optional)
The URYXXON®Relax can be operated with 6 type AA batteries independent
of the mains supply. The battery compartment is on the underside of the equip-
ment. Notice the designated polarity (+/-) marked on the battery compartment
while inserting the batteries.
Pic. 15: Battery compartment
3.9. Instrument self test
The instrument will perform an automatic self test each time it is turned on. If
an error message appears, the instrument will not start measurements. In this
case, please contact your local service provider.
3.10. Calibration
The instrument will perform an automatic calibration each time a test is run.

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3.11. Use of the instrument
All user inputs are done via a touch-screen (touch-display). All functions are
activated directly by slight pressure with the finger on explicit pictograms or text
representing the menu items.
3.11.1. Buttons
Framed areas react to pressure and trigger the action linked to it. The caption of
an area describes its function.
Examples:
Confirm / perform action
Cancel action
Equipment settings
?Check mode
Memory
Enter main menu
3.11.2. Scroll Menu
Press the up-and-down arrows on the right side of the screen to scroll through
a list of information on the left side of the screen. The desired information on the
left side is highlighted.
Strip
Password
Printer
Sound
Autostart
Battery
Language
Date/Time
Interface
SETTINGS
Display 3: Selective lists
Pressing will select the highlighted line.You can leave the menu by pres-
sing .
3.11.3. Round buttons
These buttons typically appear on screens that require a selection among serial
items. The button with a filled circle is the current selection.

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DAY
Today
All
Date
Pressing the circle will activate a selection. Save your selection by pressing
. Pressing will quit the menu without performing any changes.

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4. User menu
4.1. Flow-chart of the menu structure
SN:
ID:
(P)
Memory List
Search
Clear
Check mode
Settings
Memory
Measurement
Type
Units
Strip
Parameter order
Password
Sound Touch
Positive
Battery Backlight
Printer
Printer
Autostart
Language
Date/Time
Interface
Customization
Print setting
Negative
Positive

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4.2. Description of the menu items
• SN:
Chapter 5.5 "Changing the sequence number ("SN")"
• ID:
Chapter 5.4 "Entering the patient identification"
• (P):
Standby
• :
Main menu
• Memory:
Chapter 7 "Recall results"
• Check mode:
Chapter 8 "Quality control testing"
• Settings:
Chapter 9.1 "How to modify strip settings"
Chapter 9.2 "How to protect settings from unauthorized access"
Chapter 9.3 "How to turn the printer on and off"
Chapter 9.4 "How to enable and disable acoustic signals"
Chapter 9.5 "How to deactivate and activate the autostart"
Chapter 9.6 "How to set energy saving options for the battery mode"
Chapter 9.7 "How to change the language"
Chapter 9.8 "How to set time and date"
Chapter 9.9 "How to activate data transfer"
Chapter 9.10 "How to change the text of the printout header"
Chapter 9.11 "How to print the settings"