Wellion LUNA duo, Manual

Page 1: ...1 WELLION LUNA DUO duo MANUAL ...

Page 2: ... and total cholesterol measuring system is de signed to measure the blood glucose or total cholesterol levels in whole blood The test strips are for self testing outside the body in vitro diagnostic use It should be used only for testing glucose or total cholesterol with fresh capillary blood samples The system is suitable for users to monitor their blood glucose or total cholesterol at home by th...

Page 3: ...stions or simply need more information please contact your local dis tributor Thank you again for choosing the Wellion LUNA duo blood glucose and total choles terol measuring system Further information can be found at www wellion at en ...

Page 4: ...NA Total Cholesterol Code Strip 9 Wellion LUNA duo meter display 10 SETTING UP THE METER 11 Installing Replacing the Battery 11 Set the Date and Time 12 Coding the Meter Only for testing total cholesterol 14 Control SOLUTION TEST 15 HOW TO PERFORM A TEST 19 Preparing the lancing device 19 Measuring your blood glucose 21 Testing procedure for Total Cholesterol 23 Special warnings 24 METER MEMORY FU...

Page 5: ...ON LUNA DUO LIMITATIONS 26 Limitations of the glucose test 27 Limitations of the total cholesterol test 28 STORAGE AND PRECAUTIONS 29 TROUBLESHOOTING 31 SYMBOLS 33 SPECIFICATIONS 34 MANUFACTURER S WARRANTY 35 ...

Page 6: ... system 10 Wellion LUNA glucose test strips optional Wellion lancing device 10 Wellion lancets Compact Pouch Owners Guide Principles of the Examination Method Electrochemical biosensor technology The meter is plasma calibrated by reference instruments which are traceable to the following standard reference materials and methods Test Standard Method Glucose NIST SRM 917 Glukose Oxidase Total Choles...

Page 7: ...ip to turn on the meter and begin with the measurement OK Button WiththeOKbuttonyoucanscroll through the memory or confirm settings in the settings menu The correct reading of your data can be ensured only with the original Wellion LUNA USB cable with Micro USB connector Memory Button With the Memory button you can switch the meter ON OFF Pressing the Memory button will change the chosen set ting ...

Page 8: ...032 Slide the cover on the battery compart ment to close it Use the tip of the bat tery cover to take out the battery The Wellion LUNA duo meter Acoustic signals Normal Alert Sound a short beep Warning Alert Sound 3 short beeps Turning On Off Alert Sound a long beep Seriennummer ...

Page 9: ... the drop Reaction Zone Wellion LUNA Blood Glucose Test Strip Contact Bar Insert Electronic Contact Bar of the test strip into the Test Port of the meter to start with a measurement Sampling End Touch a blood sample or con trol solution with the tip of the test strip and the test strip will automatically sip in the drop Reaction Zone GLU CHOL 0 5µL 10µL The Wellion LUNA Total Cholesterol Code Stri...

Page 10: ...ring Unit Icon Temperature Icon Hour Minute Test strip Icon Symbol for blood or control solution Average lcon Date Reading Countdown message Error message Low Battery lcon Systemcheck Icon Test mode GLUC Glucose CHOL Cholesterol Memory Symbol for Code number ...

Page 11: ... of the meter 1 Remove the battery cover 2 Insert a new battery into the battery socket with the side facing up 3 Replace the battery cover onto the meter NOTE The current date and time information will be memorized by the meter for approxi mately 1 minute If the batteries are inserted after 1 minute the meter may prompt you to verify the current date and time The stored results and settings will ...

Page 12: ...will be the year 2 Press the Memory button to advance one year at a time until you get the correct year 3 After you set the desired year press the OK button and then the meter will enter into the month setting 4 Press the Memory button until the correct month appears 5 Press the OK button and the meter will enter into the day setting 6 Press the Memory button until the correct day appears 7 Press ...

Page 13: ...ill enter into the minute setting 11 Press the Memory button until the correct minute appears 12 Press the OK button to complete the meter setting The meter will then turn off automatically after a long beep NOTE Setting the correct time and date is important if you want to download the results to a PC or if you want to use the meter memory ...

Page 14: ...s 1 Fully insert the contact bar of the code chip into the test port of the meter with the labelled side of the chip facing upwards Wait for the code number to appear on the screen 2 Make sure the code number and test mode appearing on the screen match the code number and test mode marked on the test strip vial 3 Remove the code strip by sliding down the strip ejector J should appear on the screen...

Page 15: ... When you get your meter for the first time or start using a new box of test strips When you suspect that the meter or the test strips are not working properly Any time you get unexpected test results If you drop the meter If you want to check that your testing procedure is correct 1 Fully insert the contact bar of the test strip into the test port of the meter with the labelled side of the strip ...

Page 16: ...her drop of solution and touch the edge of the test strip to the drop of solution The control solution will be automatically drawn up the test strip into the reaction area 5 For glucose testing you can stop the sample loading after hearing a beep sound If E 8 is displayed on the screen that means the volume of sample is insufficient Please remove the strip and repeat the test procedure using a new...

Page 17: ...est strip If the problem persists with a new test strip then please contact your local distributor Out of range results may be due to not following the directions described above using an expired or damaged test strip using expired or contaminated control solution a problem with the meter WARNING If the test mode on the meter screen does not match with the test strip that you apply please remove i...

Page 18: ...mediately after removing a test strip Discard the first 3 drops of control solution and shake the vial vigorously prior to the control solution measurement Record the date opened on the test strip bottle label when you first open it If the results you get are not within the range repeat the control solution test If control solution results continue to fall outside the expected range contact your l...

Page 19: ... lancet by pushing down firmly until it is fully seated 2 Twist the protective cover off from the lancet and replace the adjustable cap onto the lancing device 3 Adjust the puncture setting on the adjustable cap for the re quired puncture depth level 1 is the lightest and 10 is the deepest Lancet Holder Lancet Ejection System Release Button 1 Shallow 2 3 4 5 6 7 8 9 Sliding Barrel Adjustable Tip P...

Page 20: ...the cocking handle again until the release button changes to red IMPORTANT Use a new sterile lancet every time you test to avoid cross contamination If alcohol wipes are used to cleanse the fingers make sure the area is dry before the blood sample is obtained Each measurement must be performed within 3 minutes otherwise the meter will turn off automatically Please remove and re insert the test str...

Page 21: ...n on and automatically switch to the glucose test mode 3 Check if the test mode displayed on the screen is correct the icon GLUC should appear to indicate the glucose test mode is activated If this does not appear please remove the test strip and re insert making sure that you have correctly followed the insert instructions If the correct icon is still not displayed please re try with a new test s...

Page 22: ...enough blood the glucose test strip needs at least 0 5 µl of blood 6 The meter will countdown from 5 to 1 and will then display the blood glucose result 7 To remove the test strip gently slide the strip ejector until the used strip comes out of the test port Alternatively you can manually pull out the used strip Remove the used lancet from the lancing device by pushing the eject button forwards wi...

Page 23: ... with the labelled side of the strip facing upwards Do not bend the test strip The Wellion LUNA duo meter will turn on and automatically switch to the Total Cholesterol mode 3 Check the test mode is correct the icon CHOL should appear to indicate the Total Cholesterol test mode is activated A code number will also appear please make sure that this is the same as the code on the test strip vial If ...

Page 24: ...ol measuring system and the test strips are plasma calibrated Use the strips before the expiration date Wellion LUNA glucose test strips must be used within 9 months of first opening the vial and Wellion LUNA cholesterol test strips must be used within 3 months of first opening the vial You must never re apply blood to the same test strip as it will cause inaccurate test results Do not reuse any t...

Page 25: ...r a long beep sound and the meter will turn on first showing a full display before entering the memory mode 2 The icon GLUC or CHOL will blink in the upper screen depending on which mem ory mode the meter is in Press the Memory button to switch between the two modes and press the OK button to set the desired mode Note TheIcon CHOL willflashalongwithacodenumberwhenintotalcholesterolmode 3 When in G...

Page 26: ... mode if 360 test results are already stored and a new one is added the oldest test result is automatically overwritten In total cholesterol memory mode if 50 test results are already stored and a new one is added the oldest test result is automatically overwritten LIMITATIONS Please observe the following limitations for obtaining accurate results with theWellion LUNA Duo Monitoring System For In ...

Page 27: ... altitude up to 3 048 m 10 000 feet without an effect on test results Additional Information for Healthcare Professionals When venous whole blood is used for the test it can be collected into heparin containing test tubes with in 30 minutes after drawing The results may be 7 lower than with a capillary sample Interferences Acetaminophen Ascorbic acid Bilirubin Cholesterol Creatinine Dopamine EDTA ...

Page 28: ... test strips give accurate results when the following lim itations are observed Hematocrit Hct percentage may affect the test result Hct levels less than 35 may cause incorrect high measurement results and Hct levels greater than 50 may cause incorrect low measurement results Please consult your medical professional if you do not know your Hct level Use only venous or fresh capillary whole blood D...

Page 29: ...rips are not recommended for critically ill patients STORAGE AND PRECAUTIONS The performance of the test strips may be affected by improper storage and handling Please note the following instructions Store the Wellion LUNA meter between 0 60 C the blood glucose test strip between 4 45 C the code strip and cholesterol test strips between 10 40 C Do not store or use the Wellion LUNA meter or test st...

Page 30: ...r with care severe shock such as dropping the meter could dam age the electronics Please keep the meter away from interferences of magnetic electromagnetic and radioactive sources Always close the bottle cap tightly immediately after removing a test strip from the test strip vial Do not take the meter apart Doing so will void the warranty If there are technical problems or questions call your loca...

Page 31: ...ing or changing the Battery E t Tem perature symbol The ambient temperature is outside of the operating temperature of the measuring system Move the meter into an area within the cor rect operating temperature and repeat the test E E 1 There could be a problem with the automatic system control of the instrument 2 Use of an incorrect or damaged code strip 3 Code strip was not inserted cor rectly Tu...

Page 32: ...correct or damaged code strip Repeat the coding procedure If the problem persists please contact your local distribu tor E 8 Sample volume is insufficient to complete the test Repeat the test with a new test strip You may want to try a deeper lancet setting to ensure you get enough blood HI Test result is higher than 600 mg dl Wash and dry your hands and repeat the test using a new test strip If t...

Page 33: ...idity Read instructions In vitro diagnostic Caution Consult accompanying documents Article number Keep away from sunlight Do not re use Do not use if the package is damaged Keep dry Manufactured by In vitro diagnostic medical device for self testing Serial number CE Certificate Comply with WEEE Directive 2012 19 EU FOR SELF TESTING RE F ...

Page 34: ...otal Cholesterol Hematocrit Range 25 60 Glucose 35 50 Total Cholesterol Memory 410 test results with date and time 360 for Glucose 50 for Total Cholesterol Operation Temperature 4 45 C Glucose 10 40 C Total Cholesterol Transport and Storage Temperature Test strips 4 30 C Meter 0 60 C Transport and Storage Relative Humidity 10 90 Battery Type One 3V CR2032 lithium battery Battery Life Approximately...

Page 35: ...e The warranty is lost if the instrument is misused poorly maintained or is tampered with Liability under this warranty is limited to the repair of defective parts or at the dis cretion of the producer to the replacement of the instrument The right to rescind the purchase agreement exists only if the replacement is also found to be defective Claims other than these will not be dealt with The warra...

Page 36: ...In vitro diagnostic medical device for self testing MED TRUST Handelsges m b H Gewerbepark 10 7221 Marz AUSTRIA www medtrust at MED TRUST Wellion and LUNA are registered trademarks W632DENMGMM RevC 10 2018 ...