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Related Manuals for Macherey-Nagel URYXXON Relax
Summary of Contents for Macherey-Nagel URYXXON Relax
- Page 1 MACHEREY-NAGEL URYXXON Relax ® User manual www.mn-net.com www.mn-net.com...
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Page 3: Table Of Contents
® Manual URYXXON Relax 1. Quickstart ……………………………………………………………………… 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. - Page 4 ® Manual URYXXON Relax 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.
- Page 5 ® Manual URYXXON Relax 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.
- Page 6 ® Manual URYXXON Relax 17.1. Manufacturer Information ………………………………………………… 73 17.2. Version history …………………………………………………………… 73 ® Manual URYXXON Relax EN, V 5.00C / 06.19...
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Page 7: 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. 10- ). After the self test the start screen will appear on the display. URYXXON STICK 10 URYXXON STICK 10 Insert strip! - Page 8 ® 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 9 ® Manual URYXXON Relax At the end of the measurement the result will be displayed on the screen and transferred to the printer and interfaces. RESULTAT 1/3 RESULT 1/3 Seq.Nr: 0001 ID: 1234567890 2019.01.15 9:47 *BLD 10 ERY/uL NORM *GLU 50 mg/dL 1.000 Display 2: Result...
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Page 10: Introduction
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 ®... -
Page 11: Sample Material
® Manual URYXXON Relax 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. -
Page 12: Labels On The Device And The Box
Réfl ectromètre / Refl ectrometro für / for / pour / para Medi-Test URYXXON ® Stick 10 930880.XXXXXX 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 Pic. 6: Examplary carton label ® URYXXON Relax URXXXX / 1.5 A... -
Page 13: Symbols Explanation
® Manual URYXXON Relax 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... -
Page 14: Unpacking And Set Up
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. -
Page 15: Note On Ambient Surrounding
Contact for the provided power pack 8. On/Off Switch (I/O) Turning the equipment on and off We recommend to use shielded cables. We recommend to make use of the hand scanner from MACHEREY-NAGEL ® Manual URYXXON Relax EN, V 5.00C / 06.19... -
Page 16: How To Plug The Instrument In
® Manual URYXXON Relax 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. -
Page 17: How To Install Batteries (Optional)
® Manual URYXXON Relax 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. -
Page 18: 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 19: Round Buttons
® Manual URYXXON Relax 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. Today Date Pressing the circle will activate a selection. Save your selection by pressing . -
Page 20: User Menu
® Manual URYXXON Relax 4. User menu 4.1. Flow-chart of the menu structure Memory List Search Clear Positive Check mode Memory Negative Measurement Settings Info User settings Strip Type Strip Admin settings Type Units Parameter order Create user User management Manage user Print user QC-Setup... -
Page 21: Description Of The Menu Items
® Manual URYXXON Relax 4.2. Description of the menu items • SN: Chapter 5.6 "Changing the sequence number ("SN")" • ID: Chapter 5.2 "Entering the patient identification" • (P): Standby • Main menu • Memory: Chapter 7 "Recall results" • Check mode: Chapter 8 "Quality control testing"... -
Page 22: Analysis Of Test Strips
® Manual URYXXON Relax 5. Analysis of test strips NOTE: The equipment settings, their availability and functional behavior depend on the interface setting of the instrument. The equipment settings in this chapter describe the operation in unidirectional mode only. For switching into the bi- directional mode refer to chapter Chapter 9.22 "How to change the interface settings". -
Page 23: Entering The Patient Identification
® Manual URYXXON Relax 5.2. 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 in the start menu brings up an alpha- numeric keypad. -
Page 24: Display Of Results
® Manual URYXXON Relax 5.3. Display of results The sequence number (Seq.No.) as well as the patient identification (ID) will be displayed with the results. RESULTAT 1/3 RESULT 1/3 URYXXON STICK 10 RESULT 2 /3 URYXXON STICK 10 RESULT 3 /3 Uryxxon Stick 10 Sample contains sediment Seq.Nr: 0001... -
Page 25: Enter A Comment To A Measurement
® Manual URYXXON Relax 5.4. Enter a comment to a measurement ® The URYXXON Relax offers a comment function to add information to a normal measurement (patient test) or a QC measurement. When activated in the set- tings (see Chapter 9.13 "How to change the measurement information") a com- ment can or must be entered after a measurement. -
Page 26: Measurement Errors
Chapter 14 "Error Messages and Fault Clear- ance". Repeat the measurement. In case of permanent errors please contact MACHEREY-NAGEL service. Measurement errors will be printed, send and stored according to the instru- ment settings. 5.6. Changing the sequence number ("SN") Pressing in the start menu brings up a numerical pad. -
Page 27: 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 11: Start menu Display 12: Main menu From here the other functions e.g. -
Page 28: Recall Results
® Manual URYXXON Relax 7. Recall results ® The URYXXON Relax has an internal memory for storage and recall of mea- surement results. Every result is automatically saved after the analysis. When the memory is full, new data will overwrite the eldest saved dataset. Access the memory by pressing in the main menu MENU... -
Page 29: How To Find Specific Results (Filtering)
® Manual URYXXON Relax Pressing opens a new dialog to print and send the displayed da- taset. The memory menu will reappear upon pressing return . By pressing further information about the sample can be obtained. 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 16). -
Page 30: Selecting Search Criteria
® Manual URYXXON Relax 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 . -
Page 31: 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 20). XX entries found Print Send Display Display 20: Search result If no matching results are found, the equipment returns to the memory menu. -
Page 32: 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 33: How To Perform A Qc Measurement
Display 23: Check mode In case several results do not match the expected results (indications in the checking solutions’ package inserts), please contact your local product repre- sentative or MACHEREY-NAGEL service. ® Manual URYXXON Relax EN, V 5.00C / 06.19... -
Page 34: Equipment Settings
® Manual URYXXON Relax 9. Equipment Settings NOTE: The equipment settings, their availability and functional behavior depend on the interface setting of the instrument. The equipment settings in this chapter describe the operation in unidirectional mode only. For switching into the bi- directional mode refer to chapter Chapter 9.22 "How to change the interface settings". -
Page 35: How To View System Information
® Manual URYXXON Relax Enter the main menu by pressing the menu key to reach the "SETTINGS" display press (Display 24 + Display 25). MENU URYXXON STICK 10 SETTINGS Info Memory User settings Admin settings Print settings Check mode Settings Display 24: User settings Display 25: Settings Within the “User settings”... -
Page 36: How To Modify The Strip Type
® Manual URYXXON Relax 9.2. How to modify the strip type ® The URYXXON Relax has data for various approved test strip types. The test strip type can be chosen in a selective list. In the "User settings" menu, the test strip type can be changed. Confirm the entry “Strip”... -
Page 37: Order Of Parameters
® Manual URYXXON Relax 9.4.3. Order of Parameters The output order of the parameters may be customized via a selective list. The parameters need to be selected in the desired order and confirmed by pressing . After the last parameter the equipment will ask whether the setting is to be saved. -
Page 38: How To Edit A User
® Manual URYXXON Relax To select the user roles, press . A check list of the four different user roles will open. Use the arrow key and to select and deselect the entries in the list. A user can be authorized for the following roles (Display 28): •... -
Page 39: How To Print A User List
® Manual URYXXON Relax 9.8. How to print a user list To print a user list select the list entry “Print users” in the menu “User manage- ment”. A list of all stored users with their respective roles and the user status (active or inactive) is printed. -
Page 40: How To Change The Qc Measurement Information
® Manual URYXXON Relax URYXXON STICK 10 QC period lapsed! Please run QC. Display 30: QC lockout To release the instrument for patient testing, please perform a positive and a negative QC measurement by pressing . Both measurements need to be evaluated as “Passed”. -
Page 41: How To Set The Qc Evaluation
® Manual URYXXON Relax 9.12. How to set the QC evaluation ® The URYXXON Relax allows for the evaluation of quality control measure- ments as “Passed” and “Failed”. Select the list entry “QC evaluation” in the menu “QC setup” and press the round button “QC user” to activate the QC evaluation. The default setting is “Off”. -
Page 42: How To Change The Language
® Manual URYXXON Relax 9.15. How to change the language Select "Language" in the instrument setup menu. The language of the ® URYXXON Relax menu can be switched to the following languages using the respective selective list: English, Deutsch, Espanol, Francais, Italiano, Portugues, Polski, Türkce, Neder- lands, Magyar, Norsk, Svenska, Suomi, Dansk, Indonesia 9.16. -
Page 43: How To Change The Text Of The Printout Header
® Manual URYXXON Relax NOTE: The UTC time setting is only important when using the interface mode “Bidi- rectional and Unidir. V2”. The UTC will be sent together with the result. 9.17. How to change the print format The information on the printout can be customized. By default the sequence number, patient ID, operator ID, strip LOT, control LOT and empty fields will be printed. -
Page 44: Other Settings
® Manual URYXXON Relax the alphanumerical pad on the display, an external keyboard or a barcode scan- ner. An overview about the entered information can be obtained by printing the instrument settings (Chapter 9.3 "Administrator settings"). 9.21. Other settings 9.21.1. Acoustic confirmation of user inputs Press behind the entry "Sound"... -
Page 45: How To Change The Interface Settings
NOTE: A comprehensive description of the interface data protocols can be obtained from your local product representative or MACHEREY-NAGEL directly. 9.23. How to print the settings Select "Print Settings" in the settings menu to print the equipment settings for documentation purposes. -
Page 46: Device Settings In Bidirectional Interface Mode
® Manual URYXXON Relax 10. Device settings in bidirectional interface mode NOTE: ® The URYXXON Relax is configured to operate in unidirectional interface mode ex works. To operate the instrument in bidirectional interface mode, please refer to chapter “Chapter 9.22 "How to change the interface settings"”. When set to bidirectional interface mode, changes to the device settings will apply. -
Page 47: How To Print A User List
® Manual URYXXON Relax entered user name and password are validated against a user list on the remote system. After successful validation, the user can operate the instrument accord- ing to the activated user roles. NOTE: In bidirectional mode the user management is only possible, when a user list is active on the remote system. -
Page 48: How To Change The Qc Measurement Information
® Manual URYXXON Relax instrument again.The device will be automatically unlocked after performing a positive and a negative control measurement (see Chapter 8.2 "How to perform a QC measurement"). When QC-evaluation is set to “Off” (see Chapter 9.12 "How to set the QC evalu- ation"), there is no need to evaluate the QC measurement. -
Page 49: Other Settings
® Manual URYXXON Relax 10.10. Other settings 10.10.1. How to activate the user accounts and user password Selecting “User accounts” in the menu “Other settings” will activate the user mode of the instrument. After the instrument start, a user login is required. If the entry “User password”... -
Page 50: Qc Lockout
® Manual URYXXON Relax Activating the entry “Strip LOT” enables the download of strip LOT data at each start of the instrument. The strip LOT data entered before the measurement are checked against these downloaded data (Chapter 10.6 "How to change the QC measurement information"). -
Page 51: Disinfection
® Manual URYXXON Relax 11. Disinfection 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 52 ® Manual URYXXON Relax ATTENTION: Ensure that the strip holder is completely clean and dry before inserting. ® Manual URYXXON Relax EN, V 5.00C / 06.19...
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Page 53: Service Menu
® Manual URYXXON Relax 12. 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 34). Upon request input the PIN "1234". A selective list with different menu items appears. -
Page 54: How To Run A Control Strip Measurement
For additional information on the control strips or in case the values do not fit the expected value ranges 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 55: How To Change The Sensitivity
® Manual URYXXON Relax CHECK MODE Insert Control strip Display 36: Insert control strip 12.5. 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 37). -
Page 56: Appointing New Sensitivity Settings
® Manual URYXXON Relax 12.5.2. Appointing new Sensitivity Settings NOTE: Technical and medical knowledge is required to appoint new sensitivity set- tings. If you do not feel confident, leave this menu without changes. By selecting the option panel "New" and confirming with the parameter selection will appear (Display 38). -
Page 57: Reported Value - (Original Threshold) - Modification
® Manual URYXXON Relax 12.5.3. Reported value – (original threshold) – modification Press to select the value that you would like to modify. Three informations are in each line: The information is always defined "X(Y)Z", e.g. "NEG (650) 0" • X: Measurement value "NEG" •... -
Page 58: 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. 13.1. Serial interface Protocol RS232, 19200 Baud, 8 bit, no parity (Pic. 10-... -
Page 59: Error Messages And Fault Clearance
® Manual URYXXON Relax 14. Error Messages and Fault Clearance The instrument differentiates between different types of error messages. Advi- sory error messages are of less importance and are displayed on the screen during handling the instrument (e.g. Please remove strip). When the corrective action has been performed, the analyzer removes the message from the screen. - Page 60 ® Manual URYXXON Relax Error Message / Error Cause Solution “QC measurement The QC reminder function is Run a positive and a nega- required” activated. The QC measure- tive control, which must ment is due and the device both evaluated is blocked for running patient “Passed”.
- Page 61 Please repeat the mea- ror" ment occured. surement. In case an error cannot be solved by the aid of the instructions above, please contact your local distributor or the MACHEREY-NAGEL Service. ® Manual URYXXON Relax EN, V 5.00C / 06.19...
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Page 62: Warranty
® Manual URYXXON Relax 15. 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 63: Technical Information
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 16.2. -
Page 64: Analytical And Clinical Performance Characteristics
® Manual URYXXON Relax 16.3. Analytical and Clinical Performance Characteristics 16.3.1. Table of results Param. Conventional International 10 Ery/µL 10 Ery/µL 50 Ery/µL 50 Ery/µL 250 Ery/µL 250 Ery/µL NORM NORM NORM 2 mg/dL 35 µmol/L 4 mg/dL 70 µmol/L 8 mg/dL 140 µmol/L 12 mg/dL... -
Page 65: Precision
* Repeat with new sample 16.3.2. Precision The precision was evaluated by using the commercially available control solu- tion Medi-Test Control, manufactured by MACHEREY-NAGEL, Düren, Germany. ® This Control is used for daily routine system check of the URYXXON urinalysis system. - Page 66 ® Manual URYXXON Relax Precision within series 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...
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Page 67: Linearity
® Manual URYXXON Relax 16.3.4. 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 68: Electromagnetic Compatibility
® Manual URYXXON Relax 16.4. Electromagnetic Compatibility ® The URYXXON Relax as a medical device is subject to particular precau- tions with regard to electromagnetic compatibility (EMC) and has to be installed and put into operation as described in Chapter 3 "Unpacking and set up". High frequency communication equipment (mobile phones, etc.) can influence the ®... - Page 69 ® Manual URYXXON Relax Electromagnetic interference resistance ® The URYXXON Relax is destined for an electromagnetic environment as described below. The ® user of URYXXON Relax should ensure that instrument is used in such environment. Interference IEC 60601-Immunity Compliance-level Electromagnetic resistance-test test level environment –...
- Page 70 ® Manual URYXXON Relax Electromagnetic interference resistance ® The URYXXON Relax is destined for an electromagnetic environment as described below. The ® user of URYXXON Relax should ensure that instrument is used in such environment. Interference IEC 60601-Immu- Compliance- Electromagnetic environment – resistance-test nity test level level...
- Page 71 ® Manual URYXXON Relax Blazed disturbances 3 V/m 3 V/m d = 1,2 for 80 MHz to 800 MHz induced by RF fields 80 MHz to 2,5 according to IEC d = 2,3 for 800 MHz to 2,5 GHz 61000-4-3 with P as rated power of trans- mitter in watt (W) according to description of transmitters manu-...
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Page 72: Waste Disposal
(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, V 5.00C / 06.19... -
Page 73: Additional Information
® Manual URYXXON Relax 17. Additional Information 17.1. 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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