URYXXON Relax EN Users Manual V2.10 Feb 2014

Manual URYXXON® Relax 9.1. How to modify strip settings………………………………………………… 75 9.1.1. Type………………………………………………………………………… 75 9.1.2. Units………………………………………………………………………… 75 9.1.3. Order of Parameters……………………………………………………… 75 9.1.4. Test Strip LOT……………………………………………………………… 76 9.2. How to protect settings from unauthorized access……………………… 76 9.3. How to turn the printer on and off…………………………………………… 76 9.4. How to enable and disable acoustic signals……………………………… 76 9.4.1. Acoustic confirmation of user inputs……………………………………… 76 9.4.2. Acoustic warning on positive results……………………………………… 76 9.5. How to deactivate and activate the autostart……………………………… 76 9.6. How to set energy saving options for the battery mode………………… 77 9.7. How to change the language………………………………………………… 77 9.8. How to set time and date…………………………………………………… 77 9.9. How to activate data transfer………………………………………………… 78 9.10. How to change the text of the printout header…………………………… 78 9.11. How to print the settings…………………………………………………… 78 10. Cleaning and maintenance…………………………………………………… 79 10.1. How to clean the housing…………………………………………………… 79 10.2. How to clean the strip holder……………………………………………… 79 11. Table of results…………………………………………………………………… 80 12. Service menu…………………………………………………………………… 81 12.1. How to reset the system (Load Default)………………………………… 81 12.2. How to control the LOT-control (LOT activate)…………………………… 81 12.2.1. Entry of test strips’ LOT…………………………………………………… 82 12.2.2. Warning on expired test strips…………………………………………… 83 12.3. How to change the sensitivity……………………………………………… 84 12.3.1. Settings Reset…………………………………………………………… 84 12.3.2. Appointing new Sensitivity Settings……………………………………… 84 12.4. Reported value – (original threshold) – modification…………………… 85 12.5. How to update the instrument……………………………………………… 86 13. Interface description…………………………………………………………… 87 13.1. Serial interface……………………………………………………………… 87 13.2. USB 1.1-interface…………………………………………………………… 87 13.3. Transmission protocol……………………………………………………… 87 13.4. Barcode scanner, PC-keyboard…………………………………………… 87 14. Error Messages and Fault Clearance………………………………………… 88 15. Warranty…………………………………………………………………………… 89 16. Technical information…………………………………………………………… 90 16.1. Technical data……………………………………………………………… 90 16.2. Security standards…………………………………………………………… 90

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Manual URYXXON® Relax 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. 4-). After the self test the start screen will appear on the display. URYXXON STICK 10

SN:

0001

ID:

1025358

(P) 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 cycle will be started. A progress bar on the display shows the remaining measurement 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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Manual URYXXON® Relax 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 UBG BIL PRO NIT KET *GLU pH SG LEU

10 ERY/ul NORM NEG NEG NEG NEG 50 mg/dl 5.0 1.0 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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Manual URYXXON® Relax 2. Introduction The URYXXON® Relax is a reflection photometer for the analysis of urine test strips. The measurements are performed under standardised conditions, measured 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. 2.1. System description 2.1.1. 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. 1: 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 calibration, the results are calculated from the reflection 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"). MN

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Manual URYXXON® Relax 3. Unpacking and set up 3.1. List of delivered parts  URYXXON® Relax reflectometer  Power pack 100 - 240 V, 47/63 Hz, 9 V  Printer paper + User manual (this booklet)

 

 Pic. 2: Content

Read the operating manual for URYXXON® Relax carefully before the first startup in order to ensure an error free operation. 3.2. Advice on 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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Manual URYXXON® Relax 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 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) 3.4. Description of instrument parts



   Pic. 3: Front view

Actuator 1. Touch-Screen 2. Test Strip Sled 3. Printer Flap 4. Serial Interface 5. USB-Interface 6. PS/2 Interface 7. Mains Connection 8. On/Off Switch (I/O)

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   Pic. 4: Backside view

Function Control of equipment functions Test strip retainer and autonomous start of analysis Opening the printer flap for paper replacement Connection of a computer Connection of a computer Connection of a keyboard or a bar code scanner Contact for the provided power pack Turning the equipment on and off

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Manual URYXXON® Relax 3.5. How to plug the instrument in

Pic. 5: Power pack

Pic. 6: DC in

Three 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 flap by pressing the rectangular key next to the printer flap (Pic. 7).

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Manual URYXXON® Relax

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 finger while closing the flap (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 equipment. 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 finger on explicit pictograms or text representing the menu items.

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Manual URYXXON® Relax 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: Confirm / 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. SETTINGS Strip Password Printer Sound Autostart Battery Language Date/Time Interface

Display 3: Selective lists

Pressing will sing .

select the highlighted line. You can leave the menu by pres­

3.8.3. Round buttons These buttons typically appear on screens DAY that require a selection among serial items. The button with a filled circle is the current selection. 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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Manual URYXXON® Relax 4. User menu 4.1. Flow-chart of the menu structure SN: ID: (P) Memory

List Search Clear

Check mode

Memory Measurement

Settings

Strip

Type Units Parameter order

Password Printer Sound

Touch Positive

Autostart Battery

Backlight Printer

Language Date/Time Interface Customization Print setting

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Manual URYXXON® Relax 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 9.7 "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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Manual URYXXON® Relax 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 lintfree 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 touchscreen. 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 leaflet 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 infectious material.

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Manual URYXXON® Relax 5.2. Display of results The sequence number (Seq.No.) as well as the patient identification (ID) will be displayed with the results. RESULT

Seq.No: 001 ID: 1234567890 2006.02.17 9:47 *BLD UBG BIL PRO NIT KET *GLU pH SG LEU

10 ERY/ul NORM NEG NEG NEG NEG 50 mg/dl 5.0 1.0 NEG

Display 4: Result

Positive findings are clearly marked by an asterisk (*) on the printout and on the display. Additionally, it is possible to enable an acoustic signal on positive fin­ dings. 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 file) or as a photocopy. The result displayed may be printed again by pressing . The return panel will lead back to the start screen. 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.

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Manual URYXXON® Relax 5.4. Entering the patient identification The patient identification 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 alphanumeric 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 field within 0.5 seconds switches through the characters displayed on the key. Wrong entries may be erased by pressing . ID

ID

1234567890 1

2

3

4

5

6

7

8

9

1234567890 ABC

0

Display 5: Entering ID (numerics)

–

ABC DEF

GHI

JKL MNO

123

PQRS TUV WXYZ -(#)

Display 6: 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 Identifications. • 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 Identifications. After entering the patient identification start the measurement. The Patient Identification is saved together with the diagnostic findings. Attention: A new ID cannot be entered before the present analysis has been completed.

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Manual URYXXON® Relax 5.5. Changing the sequence number ("SN") Pressing SN: in the start menu brings up a numerical pad. Enter a new sequence number using the keys on the pad. All following measurements will now be counted from this number on. Núm. Seq. Seq.No. 1

2

3

4

5

6

7

8

9

ABC

0

Display 7: 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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Manual URYXXON® Relax 6. Enter the main menu Pressing

on the start screen will bring up the main menu. URYXXON STICK 10

MENU Memory

SN:

0001

ID:

1025358

? Check mode Settings

(P) Display 8: Start menu

Display 9: 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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Manual URYXXON® Relax 7. Recall results The URYXXON® Relax has memory for 200 measurements. Every result is automatically 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 MODE

Memory

List

? Check mode

Search

Settings

Clear

Display 10: Main menu

Display 11: Memory mode

7.1. How to scroll through memory Pressing will bring up Display 12. Scrolling through the memory is possible by pressing the arrows on the right side. The next or previous result will be displayed. 2 Seq.Nr: 0001 ID: 1234567890 2006.02.17 9:47 *BLD UBG BIL PRO NIT KET *GLU pH SG LEU

10 ERY/ul NORM NEG NEG NEG NEG 50 mg/dl 5.0 1.0 NEG

x

Display 12: Memory contents

It is possible to print and send the dataset displayed. The memory menu will reappear upon pressing Return .

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Manual URYXXON® Relax 7.2. How to find specific results (filtering) To find a result, you may select the date of the measurement and a specific parameter. SET FILTER PAR. Day Par

Display 13: Filtering

7.2.1. Selecting the date By pressing Day you will reach the menu displayed below. DAY Today All Date

Display 14: Select day

Set the day with the buttons. Selecting "Date" will bring up a screen with the list of available dates (only days with measurements are shown on the screen). Select the desired date with the up-and-down arrows and confirm your selection by pressing . After confirmation your selection will be displayed on the screen "SET FILTER PAR."

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Manual URYXXON® Relax 7.2.2. Selecting search criteria Pressing Par in Display 13 brings up Display 15. SELECT PARAMETER ID Seq.No. Positive Not printed Not sent All

Display 15: Select parameter

Use the arrow keys to select the desired criteria and confirm with filter criteria will be displayed on the filter settings screen (Display 16).

. The

7.2.3. Display suitable matches After setting "Day" and "Parameter" the search may be started by pressing . SET FILTER PAR. DAY

Today

PAR

Positive

Display 16: Filtering

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