Macherey-Nagel URYXXON Relax User Manual
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Macherey-Nagel URYXXON Relax User Manual

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MACHEREY-NAGEL
URYXXON
Relax
®
User manual
www.mn-net.com
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  • Page 1 MACHEREY-NAGEL URYXXON Relax ® User manual www.mn-net.com www.mn-net.com...

  • Page 3: Table Of Contents

    ® Manual URYXXON Relax 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 ®...
  • Page 4 ® Manual URYXXON Relax 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.
  • Page 5 ® Manual URYXXON Relax 14. Warranty ……………………………………………………………………… 15. Technical information ……………………………………………………… 15.1. Technical data …………………………………………………………… 15.2. Security standards ……………………………………………………… 15.3. Analytical Performance Characteristics ……………………………… 15.3.1. Table of results …………………………………………………… 15.3.2. Precision …………………………………………………………… 15.3.3. Mikroalbumin ……………………………………………………… 15.3.4. Linearity …………………………………………………………… 15.3.5. Cut-off concentration ……………………………………………… 15.4.

  • Page 6: Quickstart

    ® 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. 8-  ). After the self test the start screen will appear on the display. URYXXON STICK 10 URYXXON STICK 10 Insert strip!
  • Page 7 ® Manual URYXXON Relax • 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.
  • Page 8 ® 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 15.02.2019 9:47 *BLD 10 ERY/uL NORM *GLU 50 mg/dL 1.000 Display 2: Result By pressing the printer symbol the result can be printed again.

  • Page 9: Introduction

    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.

  • Page 10: Relax

    ® Manual URYXXON Relax 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.
  • Page 11 Réfl ectromètre / Refl ectrometro für / for / pour / para ® Medi-Test URYXXON Stick 10 93088 Barcode URXXXX DD.MM.YYYY MACHEREY-NAGEL GmbH & Co. KG Neumann-Neander-Str. 6–8 · 52355 Düren · Germany Tel.: +49 24 21 969-0 · info@mn-net.com · www.mn-net.com Rev. 2018-09 Examplary carton label ® URYXXON Relax URXXXX / 1.5 A...
  • Page 12 ® Manual URYXXON Relax 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.

  • Page 13: Unpacking And Set Up

    ® 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, incl. adapter  Printer paper + User manual (this booklet) + Quick guide ...

  • Page 14: Setting Up The Instrument

    9. LAN-Interface Connection to network (serial over LAN) We recommend to use shielded cables. We 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.

  • Page 15: How To Plug The Instrument In

    ® Manual URYXXON Relax 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.

  • Page 16: How To Install Batteries (Optional)

    ® Manual URYXXON Relax 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.

  • Page 17: Use Of The Instrument

    ® Manual URYXXON Relax 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.
  • Page 18 ® Manual URYXXON Relax Today Date 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, V5.00 / 04.19...

  • Page 19: User Menu

    ® Manual URYXXON Relax 4. User menu 4.1. Flow-chart of the menu structure Memory List Search Positive Clear Negative 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...

  • Page 20: Description Of The Menu Items

    ® 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"...

  • Page 21: Analysis Of Test Strips

    ® 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.

  • Page 22: Display Of Results

    ® 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 15.02.2019 9:47 *BLD 10 ERY/uL NORM *GLU 50 mg/dL 1.000 Display 4: Result Positive findings are clearly marked by an asterisk (*) on the printout and on the display.

  • Page 23: Measurement Errors

    If the display shows "Measuring Error ..." instead of a result please read the instructions in Chapter 13 "Error Messages and Fault Clearance". Repeat the measurement. In case of permanent errors please contact MACHEREY-NAGEL service. 5.4. Entering the patient identification The patient identification needs to be entered before starting the analysis. This can be done as follows: •...

  • Page 24: Changing The Sequence Number ("Sn")

    ® Manual URYXXON Relax 5.5. Changing the sequence number ("SN") Pressing 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. Núm.

  • Page 25: Enter The Main Menu

    ® Manual URYXXON Relax 6. Enter the main menu Pressing on the start screen will bring up the main menu. URYXXON STICK 10 URYXXON STICK 10 MENU Insert strip! Memory 0001 Check mode Settings 1025358 Display 9: Start menu Display 10: Main menu From here the other functions e.g.

  • Page 26: Recall Results

    ® 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...

  • Page 27: How To Find Specific Results (Filtering)

    ® 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 (Display 14). SET FILTER PAR. Display 14: Filtering 7.2.1. Selecting the date By pressing you will reach the menu displayed below (Display 15).

  • Page 28: Selecting Search Criteria

    ® Manual URYXXON Relax 7.2.2. Selecting search criteria Pressing in Display 14 brings up Display 16. SELECT PARAMETER Seq.No. Positive Not printed Not sent Display 16: Select parameter Use the arrow keys to select the desired criteria and confirm with .

  • Page 29: How To Delete Results From Memory

    ® Manual URYXXON Relax When suitable matches are found, an option will appear, allowing to print the datasets , send them to a PC or display them on the screen (Dis- play 18). XX entries found Print Send Display Display 18: Search result If no matching results are found, the equipment returns to the memory menu.

  • Page 30: Quality Control Testing

    ® Manual URYXXON Relax 8. Quality control testing Quality control measurements should be performed regularly with check solu- tions in order to ensure the correct functioning of the combination of equipment and test strips. Every facility has to implement its own QC policy. Upon pressing ? on the start menu the "Check mode"...

  • Page 31: How To Perform A Qc Measurement

    (Display 21). CHECK MODE Negative Positive Display 21: Check mode In case several results do not match the expected results (indications in the checking solutions’ package inserts), please contact the MACHEREY-NAGEL service. ® Manual URYXXON Relax EN, V5.00 / 04.19...

  • Page 32: Equipment Settings

    ® Manual URYXXON Relax 9. Equipment Settings Enter the main menu by pressing the menu key to reach the "SETTINGS" display press (Display 22 + Display 23). MENU SETTINGS Strip Memory Password Printer Sound Check mode Autostart Battery Language Settings Date/Time Interface Display 22: Main menu...

  • Page 33: Test Strip Lot

    ® Manual URYXXON Relax be saved. Save by pressing or go back to the preprogrammed order by pressing . A change of the parameter order for the strip parameter Micro- albumin is not possible. 9.1.4. Test Strip LOT ® The LOT-administration of URYXXON Relax is deactivated in the default set- ting.

  • Page 34: How To Deactivate And Activate The Autostart

    ® Manual URYXXON Relax 9.5. How to deactivate and activate the autostart ® Select "Autostart" in the settings menu. In basic mode, URYXXON Relax auto- matically detects an applied test strip and starts the measurement. This function may be deactivated via an option panel. If autostart is deactivated, the analysis must be triggered by pressing a panel in the Start menu.

  • Page 35: How To Set Time And Date

    ® Manual URYXXON Relax 9.8. How to set time and date Select "Date/Time" in the setting menu. To change, press on the respective number. A numerical pad appears. Enter the correct number and confirm by pressing The date may be formatted in three ways. The active format is shown on a but- on the right hand side of the date (Display 24).

  • Page 36: How To Activate Data Transfer

    ® Manual URYXXON Relax 9.9. How to activate data transfer Select "Interface" on the settings menu. The data transfer via the interfaces can be activated or deactivated via an option panel. 9.10. How to change the text of the printout header Select "Customization"...

  • Page 37: Cleaning And Maintenance

    ® Manual URYXXON Relax 10. Cleaning and maintenance DANGER: 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 for the handling of potentially infec- tious material.

  • Page 38: How To Clean The Strip Holder

    ® Manual URYXXON Relax 10.2. How to clean the strip holder Wipe off urine residues from the strip holder with a lint-free cloth after each mea- surement. This prevents carry-over and drying of urine residues. To remove the strip holder for more comprehensive cleaning, make sure to turn the instrument off.

  • Page 39: Service Menu

    ® Manual URYXXON Relax 11. Service menu ® The URYXXON Relax has a password protected service menu. To enter the service menu press the touch-screen three times during the self test after turn- ing the equipment on (Display 25). Upon request input the PIN "1234". A selective list with different menu items appears.

  • Page 40: Entry Of Test Strips' Lot

    ® Manual URYXXON Relax 11.2.1. Entry of test strips’ LOT If LOT-control is activated, the actual LOT-number of the test strips can be en- tered using "Strip" in the menu "Settings" (Display 26). When selecting "LOT number" a numerical pad will appear, which can be used for entering the LOT printed on the strip packaging.

  • Page 41: Warning On Expired Test Strips

    Continue New LOT 1 strip Continue 10 strips Display 28: Expire date A Display 29: Expire date B NOTE: MACHEREY-NAGEL is not responsible for wrong measurement results due to expired test strips. ® Manual URYXXON Relax EN, V5.00 / 04.19...

  • Page 42: How To Change The Sensitivity

    ® Manual URYXXON Relax 11.3. How to change the sensitivity Select "Sensitivity" to adjust the sensitivity settings. The sensitivity of the ® URYXXON Relax may be adjusted within specified borders for all parameters except the pH value (Display 30). SENSITIVITY Default Display 30: Sensitivity A NOTE:...

  • Page 43: Reported Value - (Original Threshold) - Modification

    ® Manual URYXXON Relax SENSITIVITY Display 31: Sensitivity B Use the arrows to select the parameter that should be modified. Confirm your choice by pressing . Display 32 will appear. NEG (650) 5 + (580) 0 ++ (270) 0 – Display 32: Sensitivity C 11.3.3.

  • Page 44: How To Update The Instrument

    For additional information on the control strips or in case the values do not fit the should values in the control sheet, please consult the package insert, or contact MACHEREY-NAGEL directly. ATTENTION: Do not touch the test fields of the control strip with your fingers.

  • Page 45: Interface Description

    USB-interface (work station or laboratory information system). NOTE: A comprehensive description of the interface data protocols can be obtained from your local product representative or MACHEREY-NAGEL directly. 12.1. Serial interface Protocol RS232, 19200 Baud, 8 bit, no parity (Pic. 8-...

  • Page 46: Error Messages And Fault Clearance

    In case a fault cannot be cleared by the aid of the instructions above, please contact your local distributor or the MACHEREY-NAGEL Service. ® Manual URYXXON Relax EN, V5.00 / 04.19...
  • Page 47 ® Manual URYXXON Relax 14. Warranty The warranty for this equipment has a duration of 24 months from the date of purchase. The original copy of the bill serves as a certificate and must be sub- mitted in case of assertion of a warranty claim. The warranty expires in case of improper handling and/or maintenance of the equipment;...
  • Page 48 710 g (without batteries and power pack) Range of ambient air temperature: 10 °C–40 °C Humidity: 20 %–80 % (non-condensing) The following test-strips from Macherey-Nagel are programmed for evaluation: ® Medi-Test URYXXON Stick 10 REF 93068 Medi-Test Microalbumin REF 930874 15.2.
  • Page 49 ® Manual URYXXON Relax Param. Conventional International 1 mg/dL 17 µmol/L 2 mg/dL 35 µmol/L 4 mg/dL 70 µmol/L 30 mg/dL 0.3 g/L 100 mg/dL 1 g/L 500 mg/dL 5 g/L 25 mg/dL 2.5 mmol/L 100 mg/dL 10 mmol/L 300 mg/dL 30 mmol/L NORM NORM...
  • Page 50 * Repeat with new sample 15.3.2. Precision The precision was evaluated by using the commercially available control so- lution Medi-Test Control, manufactured by MACHEREY-NAGEL, Düren, Ger- ® many. This Control is used for daily routine system check of the URYXXON urinalysis system.
  • Page 51 ® Manual URYXXON Relax Precision LOT-to-LOT   Total measurements True positive False positive False negative True negative Specificity, % 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 Sensitivity, % 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 PPV % 100.0 100.0 100.0 100.0...
  • Page 52 ® Manual URYXXON Relax 15.3.4. Linearity Assay reportable range: Bilirubin: neg. – 1 – 2 – 4 mg/dL Blood: neg. – 10 – 50 - 250 erythrocytes/μL Glucose: neg. - norm. – 50 – 100 – 150 – 500 – ≥1000 mg/dL Ketones: neg.
  • Page 53 ® Manual URYXXON Relax 15.4. Electromagnetic Compatibility • Target environment of device use: Application in the commercial laboratory environment. • This device has been developed and tested in accordance with CISPR 11 Class A. It can cause radio interference in a domestic environment. In this case, you may need to take action to correct the interference.
  • Page 54 (EU Directive 2012/19/EU), MACHEREY-NAGEL disposes old instruments free of charge. NOTE: Disposal using public waste disposal facilities is not permitted. In case of dis- posal, please contact your MACHEREY-NAGEL representative. ® Manual URYXXON Relax EN, V5.00 / 04.19...
  • Page 55 ® Manual URYXXON Relax 16. Additional Information 16.1. Manufacturer Information MACHEREY-NAGEL GmbH & Co. KG Neumann-Neander-Str. 6–8 52355 Düren · Germany Phone: +49 2421 969-0 Fax: +49 2421 969-199 E-mail: info@mn-net.com Internet: www.mn-net.com NOTE: Please note that any serious incident that has occured in relation to the prod- uct shall be reported immediately to the manufacturer and the competent au- thority of the member state in which the incident occured.

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