URYXXON Relax EN Users Manual V2.00 March 2008

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User manual URYXXON Relax

7. Recall results ... 21 7.1 How to scroll through memory ... 22 7.2 How to find specific results (filtering) ... 23 7.2.1 Selecting the Day ... 24 7.2.2 Selecting Search Criteria ... 25 7.2.3 Display suitable matches ... 26 7.3 How to delete results from memory ... 27 8. Quality control testing... 28 8.1 How to review old QC measurements ... 28 8.2 How to perform a QC measurement ... 29 9. Equipment Settings ... 30 9.1 How to modify strip settings ... 30 9.1.1 Type ... 30 9.1.2 Units ... 31 9.1.3 Order of Parameters ... 31 9.1.4 Test Stick LOT ... 31 9.2 How to protect settings from unauthorized access ... 32 9.3 How to turn the printer on and off ... 32 9.4 How to enable and disable acoustic signals ... 32 9.4.1 Acoustic confirmation of user inputs ... 32 9.4.2 Acoustic warning on positive results ... 33 9.5 How to deactivate and activate the autostart ... 33 9.6 How to set energy saving options for the battery mode... 33 9.7 How to change the language ... 33 9.8 How to set time and date ... 34 9.9 How to activate data transfer ... 35 9.10 How to change the text of the printout header ... 35 9.11 How to print settings... 35 10. Cleaning and Maintenance ... 36 10.1 How to clean the housing ... 36 10.2 How to clean the strip holder ... 37 11. Table of Results ... 38 12. Service Menu... 39

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12.1 How to reset the system (Load Default) ... 39 12.2 How to control the LOT-control (LOT activate) ... 39 12.2.1 Entry of test sticks’ LOT ... 40 12.2.2 Warning on expired test strips ... 41 12.3 How to change the sensitivity ... 42 12.3.1 Settings Reset ... 42 12.3.2 Appointing new Sensitivity Settings ... 43 12.4 How to update the instrument ... 44 13. Interface Description ... 45 13.1 Serial Interface ... 45 13.2 USB 1.1-Interface... 45 13.3 Transmission Protocol ... 45 14. Error Messages und Fault Clearance ... 46 15. Warranty ... 47 16. Technical Information ... 48 16.1 Technical Data ... 48 16.2 Security standards ... 48

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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. 3.3-8). After the self test the start screen will appear on the display.

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Display 1 : Start menu ®

Dip a test stick (Medi-Test URYXXON Stick 10) 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) is deactivated, the measurement must be started using the start control panel (Display 1-1).

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Notice: The stick will be drawn into the instrument after 30 sec. After approximately 60 sec the result will be displayed on the screen (Display 2) and transferred to the printer and interfaces.

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Display 2 : Result

By pressing the printer symbol (Display 2-2) the result can be printed again. Choosing the return panel (Display 2-3) will lead back to the start screen. Another analysis may be started by applying the next test stick.

Notice : To start a new measurement it is not necessary to go back to the start screen. A new stick is detected at any time and the measurement is then started automatically.

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2. Introduction ®

The URYXXON Relax is a reflection photometer for the analysis of urine ® test sticks Medi-Test URYXXON Stick 10. 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 stick moves below a fixed measuring head on a slide with an embedded reference pad. The reflectometric analysis of the test stick and the reference field take place during withdrawal and release of the slide.

Pic. 2.1: Measuring Principle

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The stick is illuminated with an LED and a detector registers the intensity of light reflected by the test stick 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 Autostartfeature 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 (3.7 Use of the instrument).

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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, 9V Printer paper User manual (this booklet)

Pic. 3.1 : Content ®

Read the operating manual for URYXXON Relax carefully before the first startup in order to ensure an error free operation.

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3.2 Description of instrument parts 3

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Pic. 3.2 : Front view

Actuator 1. Touch-Screen 2. Test Stick Slide 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. 3.3 : Backside view

Function Control of equipment functions Test stick 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

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) Manual URYXXON® Relax EN V2.00 / 03-08

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3.4 How to plug the instrument in

Pic. 3.4 : Power pack

Pic. 3.5 : 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. 3.4). After plugging the power pack cable into the jack “DC in“ (Pic. 3.3-7) and connecting the power pack to the power ® socket the URYXXON Relax is ready for operation.

3.5 How to load the printer paper

Pic. 3.6 : Printer A

Pic. 3.7: Printer B

Open the printer flap by pressing the rectangular key next to the paper outlet (Pic. 3.6).

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Pic. 3.8 : Printer C

Pic. 3.9 : 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 forefinger while closing the flap (Pic. 3.8).

3.6 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. 3.10 : battery compartment

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3.7 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.

3.7.1 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 e.g. display of equipment settings

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3.7.2 Scroll Arrows 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. Once the desired information on the left side is highlighted, press to confirm your selection.

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Display 3 : Selective lists Pressing pressing

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

3.7.3 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.

Pressing the circle will activate a selection. Save your selection by pressing . Pressing will quit the menu without performing any changes. Manual URYXXON® Relax EN V2.00 / 03-08

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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 Autostart Battery

Touch Positive Backlight Printer

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4.2 Description of the Menu Items SN: 5.5 Changing the sequence number («SN») ID: 5.4 Entering the Patient Identification (P): Standby ▼: Main menu Memory: 7. Recall results Check mode: 8. Quality control testing Settings: 9.2 Password 9.1 Strip Parameters 9.3 Printer 9.4 Sound 9.5 Autostart 9.6 Battery 9.7 Languages 9.8 Date / Time 9.9 Interface 9.11 Print Settings 9.10 Customisation

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5. Analysis of Test Sticks 5.1 How to perform a measurement ®

The URYXXON Relax is very easy to use. In order to start the measurement, the test stick 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 stick is drawn into the instrument, after 60 seconds it is released. Notice: Make sure to remove excess urine by blotting the test stick carefully on a lint-free cloth.

Notice: If auto mode (Chapter 9.5 Autostart) is deactivated, the analysis needs to be started by pressing on the touch-screen.

After the measurement, the instrument will release the analysed test stick wich 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 package insert that comes with the strips.

DANGER OF INFECTION: Urine and used test sticks bare the danger of infection. Always use protective gloves during handling and disposal. The disposal of used test sticks should be performed according to the regulations for the handling of potentially infectious material.

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5.2 Display of Results The sequence number (Display 4-1) as well as the patient identification (Display 4-2) will be displayed with the results.

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Display 4 : Result

Positive findings are clearly marked by an asterisk (*) on the printout and on the display (Display 4-3). Additionally, it is possible to enable an acoustic signal on positive findings. 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 (Display 4-4). The return panel (Display 4-5) 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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5.4 Entering the Patient Identification The patient identification needs to be entered before starting the analysis. This can be done as follows: a) Directly on the equipment: Pressing in the start menu brings up an alphanumeric keypad. Enter the ID using the keys. To enter characters (i.e. “Miller”) press (Display 5-1) 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 (Display 6-2).

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Display 5 : Entering ID (numerics)

Display 6 : Entering ID (letter)

b) 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. c) 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.

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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.

5.5 Changing the sequence number ("SN") Pressing the field 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.

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. Manual URYXXON® Relax EN V2.00 / 03-08

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6. Enter the Main Menu Pressing

on the start screen will bring up the main menu.

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Display 8 : Start menu

Display 9 : Main menu

From here the other functions e.g. memory (7. Recall results), the test mode (8. Quality Control Testing) as well as the settings ( 9. Equipment Settings) can be reached.

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