Macherey-Nagel URYXXON Relax User manual

URYXXON®Relax
User manual

Manual URYXXON®Relax
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1. Quickstart ……………………………………………………………………… 59
2. Introduction……………………………………………………………………… 61
2.1. System description ………………………………………………………… 61
2.1.1. Measuring principle ……………………………………………………… 61
2.1.2. Functional principle URYXXON®Relax ……………………………… 61
3. Unpacking and set up ………………………………………………………… 62
3.1. List of delivered parts ……………………………………………………… 62
3.2. Advice on surrounding …………………………………………………… 62
3.3. Setting up the instrument ………………………………………………… 63
3.4. Description of instrument parts …………………………………………… 63
3.5. How to plug the instrument in …………………………………………… 64
3.6. How to load the printer paper …………………………………………… 64
3.7. How to install batteries (optional) ………………………………………… 65
3.8. Use of the instrument ……………………………………………………… 65
3.8.1. Buttons …………………………………………………………………… 66
3.8.2. Scroll Menu ……………………………………………………………… 66
3.8.3. Round buttons …………………………………………………………… 66
4. User menu ……………………………………………………………………… 67
4.1. Flow-chart of the menu structure ………………………………………… 67
4.2. Description of the menu items …………………………………………… 68
5. Analysis of test strips ………………………………………………………… 69
5.1. How to perform a measurement ………………………………………… 69
5.2. Display of results …………………………………………………………… 70
5.3. Measurement errors ……………………………………………………… 71
5.4. Entering the patient identication ………………………………………… 71
5.5. Changing the sequence number ("SN") ………………………………… 72
5.6. Transferring data to a PC ………………………………………………… 72
6. Enter the main menu…………………………………………………………… 73
7. Recall results …………………………………………………………………… 74
7.1. How to scroll through memory …………………………………………… 74
7.2. How to nd specic results (ltering) …………………………………… 75
7.2.1. Selecting the date………………………………………………………… 75
7.2.2. Selecting search criteria ………………………………………………… 76
7.2.3. Display suitable matches ……………………………………………… 76
7.3. How to delete results from memory ……………………………………… 77
8. Quality control testing ………………………………………………………… 78
8.1. How to review old QC measurements …………………………………… 78
8.2. How to perform a QC measurement……………………………………… 79
8.3. Control strip ………………………………………………………………… 80
9. Equipment Settings …………………………………………………………… 81
9.1. How to modify strip settings ……………………………………………… 81

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9.1.1. Type ……………………………………………………………………… 81
9.1.2. Units ……………………………………………………………………… 81
9.1.3. Order of Parameters …………………………………………………… 81
9.1.4. Test Strip LOT …………………………………………………………… 82
9.2. How to protect settings from unauthorized access …………………… 82
9.3. How to turn the printer on and off ………………………………………… 82
9.4. How to enable and disable acoustic signals …………………………… 82
9.4.1. Acoustic conrmation of user inputs …………………………………… 82
9.4.2. Acoustic warning on positive results …………………………………… 82
9.5. How to deactivate and activate the autostart …………………………… 82
9.6. How to set energy saving options for the battery mode ……………… 83
9.7. How to change the language ……………………………………………… 83
9.8. How to set time and date ………………………………………………… 84
9.9. How to activate data transfer ……………………………………………… 85
9.10. How to change the text of the printout header ………………………… 85
9.11. How to print the settings ………………………………………………… 85
10. Cleaning and maintenance ………………………………………………… 86
10.1. How to clean the housing………………………………………………… 86
10.2. How to clean the strip holder …………………………………………… 86
11. Table of results………………………………………………………………… 87
12. Service menu ………………………………………………………………… 89
12.1. How to reset the system (Load Default) ……………………………… 89
12.2. How to control the LOT-control (LOT activate) ………………………… 89
12.2.1. Entry of test strips’ LOT………………………………………………… 90
12.2.2. Warning on expired test strips ………………………………………… 91
12.3. How to change the sensitivity …………………………………………… 92
12.3.1. Settings Reset ………………………………………………………… 92
12.3.2. Appointing new Sensitivity Settings…………………………………… 92
12.4. Reported value – (original threshold) – modication ………………… 93
12.5. How to update the instrument …………………………………………… 94
13. Interface description ………………………………………………………… 95
13.1. Serial interface …………………………………………………………… 95
13.2. USB 1.1-interface ………………………………………………………… 95
13.3. Transmission protocol …………………………………………………… 95
13.4. Barcode scanner, PC-keyboard ………………………………………… 95
14. Error Messages and Fault Clearance……………………………………… 96
15. Warranty………………………………………………………………………… 97
16. Technical information………………………………………………………… 98
16.1. Technical data …………………………………………………………… 98
16.2. Security standards………………………………………………………… 98
16.2.1. Technical documentation ……………………………………………… 98
16.3. Waste disposal ………………………………………………………… 103

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1. Quickstart
Unpack the instrument and place it on an even, hard surface. Connect the pow-
er supply and turn the equipment on with the On/Off-switch (Pic. 4-). 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.
• Blot by touching the edge of the strip to a paper towel to remove excess urine.
• Place the strip on the strip holder
• Slide or push the strip to the end of the channel. 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
.
Notice:
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
2006.02.17 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.
Notice:
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
The URYXXON® Relax is a reection photometer for the analysis of urine test
strips. The measurements are performed under standardised conditions, mea-
sured values may be displayed, printed and transfered 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. System description
2.1.1. Measuring principle
The test strip moves below a xed measuring head on a sled with an embedded
reference pad. The reectometric analysis of the test strip and the reference
eld take place during withdrawal and release of the sled.
Pic. 1: Measuring Principle
The strip is illuminated with an LED and a detector registers the intensity of light
reected by the test strip at three different wavelengths. Using an internal cali-
bration, the results are calculated from the reection values. Whenever samples
are strongly alkaline, a density correction is automatically conducted.
2.1.2. 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 3.8 "Use of the
instrument").

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3. Unpacking and set up
3.1. List of delivered parts
URYXXON® Relax reectometer
 Power pack 100 – 240 V, 47/63 Hz, 9 V, incl. adapter
Printer paper
+ User manual (this booklet)



Pic. 2: Content
Read the operating manual for URYXXON® Relax carefully before the rst start-
up in order to ensure an error free operation.
3.2. Advice on surrounding
If the device is exposed to higher temperature uctuations (e.g. after transport
or distribution), it must be switched on not before sufcient acclimatization is giv-
en. The device should not be used close to electrical elds (e.g. by microwaves,
radio units et cetera). In worst case the measurement results can be affected.

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3.3. 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 elds
• Do not place the instrument near heating plates, ovens or radiators
• Do not expose the instrument to strong light sources (i.e. direct sunlight)
3.4. Description of instrument parts



Pic. 3: Front view
  

Pic. 4: Backside view
Actuator Function
1. Touch-Screen Control of equipment functions
2. Test Strip Sled Test strip retainer and autonomous start of analysis
3. Printer Flap Opening the printer ap 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. PS/2 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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3.5. How to plug the instrument in
Pic. 5: Power pack Pic. 6: DC in
Four adapters are provided for adapting the power pack to the available mains
connection. The adapter matching the mains connection is plugged on to the
power pack (Pic. 5). After plugging the power pack cable into the jack "DC IN"
(Pic. 4-and connecting the power pack to the power socket the URYXXON®
Relax is ready for operation.
3.6. How to load the printer paper
Pic. 7: Printer A Pic. 8: Printer B
Open the printer ap by pressing the rectangular key next to the printer ap (Pic.
7).

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Pic. 9: Printer C Pic. 10: 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 n-
ger while closing the ap (Pic. 9 + Pic. 10).
3.7. How to install batteries (optional)
The URYXXON®Relax can be operated with 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. 11: Battery compartment
3.8. 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 nger on explicit pictograms or text
representing the menu items.

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3.8.1. Buttons
Framed areas react to pressure and trigger the action linked to it. The caption of
an area describes its function.
Examples:
Conrm / perform action
Cancel action
display of equipment settings
3.8.2. 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 .
3.8.3. Round buttons
These buttons typically appear on screens that require a selection among serial
items. The button with a lled 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.

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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
Control strip
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 identication"
• (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"

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5. Analysis of test strips
5.1. How to perform a measurement
The URYXXON®Relax is very easy to use. In order to start the measurement,
the test strip is placed on the strip holder. The instrument automatically detects
a new strip and starts the measurement. A progress bar appears, that indicates
the remaining analysis time. After 30 seconds the test strip is drawn into the
instrument.
Note:
Make sure to remove excess urine by blotting the test strip carefully on a lint-
free cloth.
Note:
If auto mode (Chapter 9.5 "How to deactivate and activate the autostart") is
deactivated, the analysis needs to be started by pressing on the touch-
screen.
After the measurement, the instrument will release the analyzed test strip which
can now be discarded. The result is displayed on the screen and is transferred
via the interfaces and/or printed according to equipment settings.
For additional information on the test strip, please read the instruction leaet
that comes with the strips.
DANGER OF INFECTION:
Urine and used test strips bare the danger of infection. Always use protective
gloves during handling and disposal. The disposal of used test strips should
be performed according to the regulations of the handling of potentially infec-
tious material.

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5.2. Display of results
The sequence number (Seq.No.) as well as the patient identication (ID) will be
displayed with the results.
RESULT
Seq.No: 001
ID: 1234567890
2006.02.17 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 4: Result
Positive ndings are clearly marked by an asterisk (*) on the printout and on the
display. Additionally, it is possible to enable an acoustic signal on positive n
dings. For the evaluation of the Microalbumin test strips, ndings are displayed
with an additional statement (Repeat with new sample, normal, abnormal, high
abnormal). Additionally, it is possible to enable an acoustic signal for the ndings
"Repeat with new sample", "abnormal" and "high abnormal".
Seq.Nr: 001
ID: 1234567890
2014.02.10 9:47
ALB 10 mg/L
KRE 10 mg/dL
A:K *
* Repeat with new
sample
RESULT
Display 5: Result Microalbumin
The printout is light-sensitive and may turn yellow when exposed to light during
storage. For archiving purposes the printouts should be kept in a dark place
(patient le) or as a photocopy.
The result displayed may be printed again by pressing . The return panel
will lead back to the start screen.

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5.3. Measurement errors
If the display shows "Measuring Error ..." instead of a result please read the
instructions in Chapter 14 "Error Messages and Fault Clearance".
Repeat the measurement. In case of permanent errors please contact
MACHEREY-NAGEL service.
5.4. Entering the patient identication
The patient identication needs to be entered before starting the analysis. This
can be done as follows:
• Directly on the equipment: Pressing
ID:
in the start menu brings up an alpha-
numeric keypad. Enter the ID using the keys. To enter characters (i.e. "Miller")
press ABC to change the character entry. Repeated pressing on the same
eld within 0.5 seconds switches through the characters displayed on the key.
Wrong entries may be erased by pressing .
7 8 9 0
456
1 2 3 ABC
1234567890
ID
Display 6: Entering ID (numerics)
-(#)
– ABC DEF 123
GHI JKL MNO
PQRS TUV WXYZ
IDID
ABCDEFGH
Display 7: Entering ID (letter)
• Using a standard PC-keyboard: Connect the keyboard to the PS/2 jack in the
backside of the instrument. User inputs on the keyboard will automatically be
interpreted as Patient Identications.
• Using a bar code reader: Connect the barcode reader to the PS/2 jack in the
backside of the instrument. Barcode readings will automatically be interpreted
as Patient Identications.
After entering the patient identication start the measurement. The Patient Iden-
tication is saved together with the diagnostic ndings.
Attention:
A new ID cannot be entered before the present analysis has been completed.

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5.5. Changing the sequence number ("SN")
Pressing
SN:
in the start menu brings up a numerical pad. Enter a new se-
quence number using the keys on the pad. All following measurements will now
be counted from this number on.
7 8 9 0
4 5 6
1 2 3
Núm. Seq.
Seq.No.
1234
Display 8: Seq.-Input
5.6. Transferring data to a PC
The results may be transferred to a PC via the USB- or RS232-interface.
A detailed description of the interface can be found in Chapter 13 "Interface
description".

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6. Enter the main menu
Pressing on the start screen will bring up the main menu.
0001
1025358
SN:
ID:
(P)
URYXXON STICK 10URYXXON STICK 10
Insert strip!
Display 9: Start menu
?
MENU
Memory
Settings
Check mode
Display 10: Main menu
From here the other functions e.g. memory (Chapter 7 "Recall results"), the test
mode (Chapter 8 "Quality control testing") as well as the settings (Chapter 9
"Equipment Settings") can be reached.

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7. Recall results
The URYXXON®Relax has memory for 200 measurements. Every result is au-
tomatically saved after the analysis. After 200 measurements, new data will
overwrite the eldest saved dataset.
Access the memory by pressing in the main menu .
?
MENU
Memory
Settings
Check mode
Display 11: Main menu
MEMORY MODE
List
Clear
Search
Display 12: Memory mode
7.1. How to scroll through memory
Pressing will bring up Display 13. Scrolling through the memory is possible
by pressing the arrows on the right side. The next or previous result
will be displayed.
x
2
Seq.Nr: 0001
ID: 1234567890
2006.02.17 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 13: Memory contents
It is possible to print and send xthe dataset displayed. The memory
menu will reappear upon pressing return .