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

Manual URYXXON®Relax
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Manual URYXXON®Relax EN, V 5.00C / 06.19
1. Quickstart ……………………………………………………………………… 7
2. Introduction……………………………………………………………………… 10
2.1. Intended Use ……………………………………………………………… 10
2.2. Intended User ……………………………………………………………… 10
2.3. Indications for use ………………………………………………………… 10
2.4. Testing population ………………………………………………………… 10
2.5. Sample material …………………………………………………………… 11
2.6. System description ………………………………………………………… 11
2.6.1. Measuring principle …………………………………………………… 11
2.6.2. Functional principle URYXXON®Relax ……………………………… 11
2.7. Safety warnings ………………………………………………………… 11
2.8. Labels on the device and the box ……………………………………… 12
2.9. Symbols explanation …………………………………………………… 13
3. Unpacking and set up ………………………………………………………… 14
3.1. List of delivered parts ……………………………………………………… 14
3.2. Consumables ……………………………………………………………… 14
3.3. Note on ambient surrounding……………………………………………… 15
3.4. Setting up the instrument ………………………………………………… 15
3.5. Description of instrument parts …………………………………………… 15
3.6. How to plug the instrument in …………………………………………… 16
3.7. How to load the printer paper……………………………………………… 16
3.8. How to install batteries (optional) ………………………………………… 17
3.9. Instrument self test ………………………………………………………… 17
3.10. Calibration ………………………………………………………………… 17
3.11. Use of the instrument …………………………………………………… 18
3.11.1. Buttons ………………………………………………………………… 18
3.11.2. Scroll Menu …………………………………………………………… 18
3.11.3. Round buttons ………………………………………………………… 19
3.11.4. Check boxes ………………………………………………………… 19
4. User menu ……………………………………………………………………… 20
4.1. Flow-chart of the menu structure ………………………………………… 20
4.2. Description of the menu items …………………………………………… 21
5. Analysis of test strips ………………………………………………………… 22
5.1. How to perform a measurement ………………………………………… 22
5.2. Entering the patient identification ………………………………………… 23
5.3. Display of results …………………………………………………………… 24
5.4. Enter a comment to a measurement …………………………………… 25
5.5. Measurement errors ……………………………………………………… 26
5.6. Changing the sequence number ("SN") ………………………………… 26
5.7. Transferring data to a PC ………………………………………………… 26
6. Enter the main menu…………………………………………………………… 27
7. Recall results …………………………………………………………………… 28

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7.1. How to scroll through memory …………………………………………… 28
7.2. How to find specific results (filtering) …………………………………… 29
7.2.1. Selecting the date ……………………………………………………… 29
7.2.2. Selecting search criteria ……………………………………………… 30
7.2.3. Display suitable matches ……………………………………………… 30
7.3. How to delete results from memory ……………………………………… 31
8. Quality control testing ………………………………………………………… 32
8.1. How to review old QC measurements …………………………………… 32
8.2. How to perform a QC measurement ……………………………………… 33
9. Equipment Settings …………………………………………………………… 34
9.1. How to view system information ………………………………………… 35
9.2. How to modify the strip type ……………………………………………… 36
9.3. Administrator settings ……………………………………………………… 36
9.4. How to modify strip settings ……………………………………………… 36
9.4.1. Type ……………………………………………………………………… 36
9.4.2. Units …………………………………………………………………… 36
9.4.3. Order of Parameters …………………………………………………… 37
9.5. User management ………………………………………………………… 37
9.6. How to create a new user ………………………………………………… 37
9.7. How to edit a user ………………………………………………………… 38
9.8. How to print a user list……………………………………………………… 39
9.9. QC-setup …………………………………………………………………… 39
9.10. How to set a QC reminder ……………………………………………… 39
9.11. How to change the QC measurement information …………………… 40
9.12. How to set the QC evaluation …………………………………………… 41
9.13. How to change the measurement information ………………………… 41
9.14. Instrument setup ………………………………………………………… 41
9.15. How to change the language …………………………………………… 42
9.18. How to change the text of the printout header ………………………… 43
9.19. How to change the definitions for emergency measurements ……… 43
9.20. How to change the default user ………………………………………… 43
9.21. Other settings ……………………………………………………………… 44
9.21.1. Acoustic confirmation of user inputs ……………………………… 44
9.21.2. Acoustic warning on positive results ……………………………… 44
9.21.3. How to deactivate and activate the autostart ……………………… 44
9.21.4. How to turn the printer on and off…………………………………… 44
9.21.5. How to activate the user accounts and user password ………… 44
9.21.6. How to set energy saving options for the battery mode ………… 44
9.22. How to change the interface settings …………………………………… 45
9.23. How to print the settings ………………………………………………… 45
10. Device settings in bidirectional interface mode ………………………… 46
10.1. Administrator settings …………………………………………………… 46

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10.2. User management ………………………………………………………… 46
10.3. How to print a user list …………………………………………………… 47
10.4. QC-setup…………………………………………………………………… 47
10.5. How to set a QC reminder ……………………………………………… 47
10.6. How to change the QC measurement information …………………… 48
10.7. How to set the QC evaluation …………………………………………… 48
10.8. How to change the measurement information ………………………… 48
10.9. Instrument setup ………………………………………………………… 48
10.10. Other settings …………………………………………………………… 49
10.10.1. How to activate the user accounts and user password ………… 49
10.11. How to change the remote settings …………………………………… 49
10.12. QC lockout ……………………………………………………………… 50
11. Disinfection …………………………………………………………………… 51
11.1. How to clean and disinfect the housing ………………………………… 51
11.2. How to clean and disinfect the strip holder …………………………… 51
12. Service menu ………………………………………………………………… 53
12.1. How to reset the system (Load Default)………………………………… 53
12.2. How to update the instrument (Program update) ……………………… 53
12.3. How to set the standby (Set standby)…………………………………… 53
12.4. How to run a control strip measurement ……………………………… 54
12.5. How to change the sensitivity …………………………………………… 55
12.5.1. Settings Reset ………………………………………………………… 55
12.5.2. Appointing new Sensitivity Settings ………………………………… 56
12.5.3. Reported value – (original threshold) – modification …………… 57
13. Interface description ………………………………………………………… 58
13.1. Serial interface …………………………………………………………… 58
13.2. USB 1.1-interface ………………………………………………………… 58
13.3. Transmission protocol …………………………………………………… 58
13.4. Barcode scanner, PC-keyboard ………………………………………… 58
14. Error Messages and Fault Clearance……………………………………… 59
15. Warranty ………………………………………………………………………… 62
16.Technical information ………………………………………………………… 63
16.1. Technical data……………………………………………………………… 63
16.2. Security standards………………………………………………………… 63
16.3. Analytical and Clinical Performance Characteristics ………………… 64
16.3.1. Table of results ……………………………………………………… 64
16.3.2. Precision ……………………………………………………………… 65
16.3.4. Linearity ……………………………………………………………… 67
16.3.5. Cut-off concentration ………………………………………………… 67
16.4. Electromagnetic Compatibility …………………………………………… 68
16.5. Waste disposal …………………………………………………………… 72
17. Additional Information ……………………………………………………… 73

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17.1. Manufacturer Information ………………………………………………… 73
17.2. Version history …………………………………………………………… 73

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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. 10-). After the
self test the start screen will appear on the display.
0001
1025358
SN:
ID:
URYXXON STICK 10
(P)
URYXXON 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 analysis
time.
NOTE:
If "Autostart" (Chapter 9.21.3 "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.
Seq.Nr: 0001
ID: 1234567890
2019.01.15 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
RESULTAT 1/3RESULT 1/3
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. When the comment function is activated the measurement re-
sult needs to be confirmed after entering the comment.

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2. Introduction
This instruction for use is provided for the URYXXON®Relax model 930880 and
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®Relax provides semi-quantitative
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®Relax instrument is not in-
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.

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2.5. Sample material
For suitable sample material refer to the instructions for use of the correspond-
ing test strips.
2.6. System description
2.6.1. 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.
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.
2.6.2. 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").
2.7. Safety warnings
The following safety warnings are used throughout the manual:
- DANGER: defines a danger which can result in serious injury or death.

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- 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.
2.8. 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
930880.XXXXXX
URYXXON®Relax (Connect)
Reflektionsphotometer / Reflection photometer
Réflectromètre / Reflectrometro für / for / pour / para
Medi-Test URYXXON®Stick 10
URXXXX
DD.MM.YYYY
Barcode
Pic. 6: 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
Pic. 7: Exemplary type plate label

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2.9. 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. 8: Content
Check all delivered parts for visible damages. In case a part is damaged, please
contact your local distributor or MACHEREY-NAGEL.
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)
• RS232 to LAN converter for connection to LIMS (Please contact
MACHEREY-NAGEL for further information and instructions)

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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.
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. 9: Front view

df eg
Pic. 10: 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. PS2 - Interface Connection of a keyboard or a bar code scanner 2
7. Mains Connection Contact for the provided power pack
8. On/Off Switch (I/O) Turning the equipment on and off
1We recommend to use shielded cables.
2We recommend to make use of the hand scanner from MACHEREY-NAGEL

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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.
3.6. How to plug the instrument in
Pic. 11: Power pack Pic. 12: DC in
Four adapters are provided for adapting the power pack to the available mains
connection. The connector pins sealing is removed and the adapter matching
the mains connection is plugged on to the power pack (Pic. 11). After plugging
the power pack cable into the jack "DC IN" (Pic. 10-g)and connecting the power
pack to the power socket the URYXXON® Relax is ready for operation.
3.7. How to load the printer paper
Pic. 13: Printer A Pic. 14: Printer B
Open the printer flap by pressing the rectangular key next to the printer flap
(Pic. 13).

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Pic. 15: Printer C Pic. 16: 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. 15 + Pic. 16).
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 device.
Notice the designated polarity (+/-) marked on the battery compartment while
inserting the batteries.
Pic. 17: 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 per-
formed.

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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
Enable/Disable
Equipment and user settings
QC-Evaluation
?Check mode
Memory
Emergency
New user
PSW
Password
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.
URYXXON STICK 10ADMIN SETTINGS
Strip
User management
QC-setup
Measurement info
Instrument setup
Remote settings
Interface
Display 3: Selective lists
Pressing will select the highlighted line.You can leave the menu by pres-
sing .

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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.
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.
Pressing the entry of the filled circle will deactivate the function in some menus
(Chapter 9.22 "How to change the interface settings").
3.11.4. Check boxes
Check boxes typically appear on screens that require a multiple selection among
a list of entries. The filled boxes represent a function being enabled, whereas an
empty box means disabled. For switching from enabled to disabled press .
Save your selection by pressing -Icon.
URYXXON STICK 10OTHER SETTINGS
Sound
Printer
Autostart
Printer
User accounts
User password
Pic. 18: Enable and disable check boxes

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4. User menu
4.1. Flow-chart of the menu structure
SN:
ID:
i
(P)
Memory List
Search
Clear
Check mode
Settings
Memory
Measurement
Type
Type
Negative
Units
Strip
User settings
Positive
Strip
Info
Parameter order
Language
Admin settings
User management Create user
Date /Time
Customization
Other settings
QC reminder
Manage user
Print format
Print user
QC-Setup
QC-Info
Default user
QC-Evaluation
Mesurement info
Instr. setup
Remote settings
Interface
Print settings Set emergency