Wellion LEONARDO GLU/CHOL plus, Owner'S Manual

Page 1: ...OWNER S GUIDE ...

Page 2: ... LEONARDO GLU CHOL plus Blood Glucose and Cholesterol Monitoring System is included in this manual The Wellion LEONARDO GLU CHOL plus Blood Glucose and Cholesterol Monitoring System contains two test modes glucose mode and cholesterol mode It has many convenient new features to help you manage test results such as hypoglycemia and hyperglycemia warnings before after meal marker exercise marker and...

Page 3: ... with diabetes or in clinical settings by healthcare professionals as an aid in monitoring blood glucose level and cholesterol level in diabetes mellitus It is not indicated for diagnosis or screening of diabetes or for neonatal use IMPORTANT Dehydration Severe dehydration may lead to inaccurate blood glucose test re sults If you suspect you are severely dehydrated contact your healthcare profes s...

Page 4: ...ring kit includes the following items Wellion LEONARDO GLU CHOL plus meter incl batteries Wellion LEONARDO Glucose Strips optional Wellion LEONARDO Cholesterol Strips optional Wellion Lancing device Wellion Lancets Compact Pouch Owner s guide Easy Start Picture Guide ...

Page 5: ... Wellion LEONARDO USB cable AB 000000 AB 000000 CHOL CHOL CHOL MED TRUST Handelsges m b H Gewerbepark 10 7221 Marz AUSTRIA www wellion at www medtrust at W11 40ECW RevA 03 2016 0197 WELL11 00ECW MED TRUST Handelsges m b H Gewerbepark 10 7221 Marz AUSTRIA www wellion at www medtrust at W11 40ECW RevA 03 2016 0197 WELL11 00ECW Arrow buttons Scroll between selections when setting up the meter Scroll ...

Page 6: ...ulin Marker displayed when marking a result as being near to medication insulin intake or viewing a marked result hypo warning displayed when Setting up your hypoglycemic threshold value Indicates your test result when at or below your hypoglycemic threshold value Indicates the memorized result when at or below your hypoglycemic threshold value hyper warning ketose awareness warning displayed when...

Page 7: ...not be changed Ctl indicates the meter is in control solution mode or shows a mem orized control solution result Temperature icon indicates the meter is outside of its operating temperature The meter will not test if outside of this range Move the meter to an environment within its operating temperature range such as indoors and wait 30 minutes before testing Operating temperature for glucose test...

Page 8: ...est strip port on the meter Sampling Area The area where the blood sample or control solution is applied IMPORTANT Be sure to use only the Wellion LEONARDO Blood Glucose Test Strip with the Wellion LEONARDO GLU CHOL plus Meter Other brands of test strips will not work with the meter The Wellion LEONARDO Blood Glucose Test Strips are sensitive to moisture and light XXX it is important to tightly cl...

Page 9: ...curate and meaningful result Contact Points Insert this end to the test strip port on the meter Sampling Area The area where the blood sample or control solution is applied CHOL CHOL IMPORTANT Be sure to use only the Wellion LEONARDO Cholesterol Test Strip with the Wellion LEONARDO GLU CHOL plus Meter Other brands of test strips will not work with the meter TheWellion LEONARDO CholesterolTest Stri...

Page 10: ... CHOL plus Meter Step 1 Turn the meter off Remove the battery cover on the back of the meter by pushing the tab and pulling the door up Remove the old batteries Step 2 Insert the new batteries with the side up They do not snap into place but rest on the metal contact The door holds the batteries down Put the battery door back into place and snap it closed G Chol Chol lu G Chol lu AB 000000 CHOL Gl...

Page 11: ...d when the batteries are being changed Discard used batteries according to your local guidelines The meter uses 2 x 3 volt lithium batteries coin cell CR2032 This type of battery can be found in many stores Always keep a spare packaged battery on hand Be sure the batteries go in with the side up Remove the batteries if you are not going to use the meter for a long time Setting the Clock Material y...

Page 12: ... will show on the screen press the OK button to enter date and time set up mode Step 3 Set Month The current month will flash Use the arrow buttons to select the correct month Press the OK button to confirm your choice and advance to set the day Step 4 Set Day The current day will flash Use the arrow buttons to select the correct day Press the OK button to confirm your choice and advance to set th...

Page 13: ...lash Use the arrow buttons to select the correct minute Press the OK button to confirm your choice and the result of your date and time correction will flash as a whole Press the arrow buttons to select the next function to setup or insert a test strip and begin testing You can also turn off the meter by pressing and holding the OK button until the display screens shows OFF Anytime during setup yo...

Page 14: ...he LCD screen will show hyper if your blood glucose test result is above your high glucose threshold level value hyperglycemia level Please consult your physician or healthcare provider on your individual recommendation for the Hypo and Hyper alarm thresholds IMPORTANT Do not alter or stop your medication based on this feature always consult your physician or healthcare provider before altering or...

Page 15: ...awareness threshold Press the OK button to enter hyper setup Use the arrow buttons to adjust the threshold for your individual hyper warning awareness threshold Confirm your choice with OK Step 4 Hypo warning Press the OK button to enter hypo se tup Use the arrow buttons to adjust the threshold for your individual hypo warning Confirm your choice with OK Press the arrow buttons to select the next ...

Page 16: ...ized by the meter TURNING ON OFF TONE SOUND Turning off the beeper will cause you to miss many important cues from your meter such as confirmation or error messages Material you will need Your Wellion LEONARDO GLU CHOL plus Meter Step 1 With the meter turned off press and hold the OK button until the screen displays FunC Glu Glu ...

Page 17: ...u can also turn off the meter by pressing and holding the OK button until the display screens shows OFF Anytime during setup you may insert a test strip to begin testing The changes you have confirmed with OK so far will be memorized by the meter G Chol lu Setting the Alarm You can set up a total of 6 alarms 3 for glucose and 3 for cholesterol on your Wellion LEONARDO GLU CHOL plus Meter The defau...

Page 18: ...ld the OK but ton until the screen displays FunC Step 2 Release the OK button and the meter will show the current date and time will flash together with SEt Press the arrow buttons until to display shows the alarm symbol XXX together with SEt Press the OK button to enter alarms set up Step 3 The display screen will flash Glu or Chol For setting up alarms on glucose testing select Glu using the arr...

Page 19: ...the arrow buttons to select the correct minutes Press OK to confirm your choice and advance to set alarm 2 Step 7 Set alarm 2 and 3 following steps 4 to 6 Press the arrow buttons to select the next function to setup or insert a test strip and begin testing You can also turn off the meter by pressing and holding the OK button until the display screens shows OFF Anytime during setup you may insert a...

Page 20: ...RDO Cholesterol Test Strips Materials your will need A code card for the Wellion LEONARDO Cholesterol Test Strip A Wellion LEONARDO Cholesterol Test Strip Your Wellion LEONARDO GLU CHOL Plus Meter NOTE Make sure the Wellion LEONARDO Cholesterol Test Strip is not expired Check the test strip expiration date XX on the test strip foil Make sure the code card is securely lodged into the code card port...

Page 21: ...inserting a test strip the code number will then be memorized by the meter Step 5 Confirming the code number Insert a cholesterol test strip into the meter with the blood sample reaction zone facing up and ensure the test strip contact points are inserted all the way 123 123 AB 000000 MED TRUST Handelsges m b H Gewerbepark 10 7221 Marz AUSTRIA www wellion at www medtrust at W10 40ECW Rev A 03 2016...

Page 22: ...TE If the code number displayed on the screen does not match the code number printed on the test strip foil pouch or package it will create inaccurate test results If error messages E 1 E 2 etc appear see Solving Problems Begin testing by inserting a test strip or turn off the meter by pressing and holding OK until the meter display screen shows OFF into the meter The meter will turn on automatica...

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Page 24: ...eter for the first time You open a new bottle of Wellion LEONARDO Blood Glucose Test Strips You leave the cap of the test strip vial open for a while You drop the meter You suspect your Wellion LEONARDO GLU CHOL plus Meter and Wellion LEONARDO Blood Glucose Test Strips are not working properly The blood glucose test results do not reflect how you feel You want to practise the testing procedure Mat...

Page 25: ...Level 0 Level 1 and Level 2 with the Wellion LEONARDO Blood Glucose Test Strip Other brands of control solution will produce inaccurate results Always check the expiration date XX DO NOT use control solutions if expired Mark the newly opened bottle of control solution with the date opened Discard any unu sed control solution 3 months after opening DO NOT FREEZE or REFRIGERATE Store the control sol...

Page 26: ...rom the bottle replace the bottle cap immediately and close it tightly Do not use wet or damaged test strips Keep away from direct sunlight and heat XXX Store the test strip bottle in a dry cool place Record the date opened on the test strip bottle label when you first open it 6 months after first opened discard the bottle and any remaining test strips Make sure you are testing in an environment b...

Page 27: ...t strip bottle If the reading does not fall within the control range printed on the test strip bottle seethechapter ControlSolutionTroubleShooting Step 8 Remove the used test strip either by pushing the eject button if available or by pulling it out with your hand The meter will turn off automatically The meter will also time out after 2 minutes of inactivity Perform other levels of control soluti...

Page 28: ...the performance of theWellion LEONARDO GLU CHOL plus Blood Glucose and Cholesterol Monitoring System using the testing solution with a known range of cholesterol Control solutions are sold separately You should perform control solution testing when Using the meter for the first time You open a new package of Wellion LEONARDO Cholesterol Test Strips You drop the meter You suspect your Wellion LEONA...

Page 29: ...ways check the expiration date XX DO NOT use control solutions if expired Mark the newly opened bottle of control solution with the date opened Discard any un used control solution 3 months after opening DO NOT FREEZE or REFRIGERATE Store the control solutions at 4 C 30 C Step 1 You must code the meter before performing a cholesterol control solution test see the section Coding the Meter Step 2 In...

Page 30: ...ood drop icon if the test strip has been inserted correctly into the test strip port AB 000000 AB 000000 CHOL CHOL MED TRUST Handelsges m b H Gewerbepark 10 7221 Marz AUSTRIA www wellion at www medtrust at W11 40ECW RevA 03 2016 0197 WELL11 00ECW MED TRUST Handelsges m b H Gewerbepark 10 7221 Marz AUSTRIA www wellion at www medtrust at W11 40ECW RevA 03 2016 0197 WELL11 00ECW Glu Chol Step 3 The c...

Page 31: ...within the control range printed on the test strip package see the chapter Control Solution Trouble Shooting Step 9 Remove the used test strip either by pushing the eject button if available or by pulling it out with your hand The meter will turn off automatically The meter will also time out after 2 minutes of inactivity CHOL GLU CHOL GLU CHOL GLU CHOL GLU CHOL GLU CHOL GLU CHOL GLU CHOL GLU CHOL...

Page 32: ...be stored into the meter s memory and indicated by ctl icon Replace the bottle cap on the control solution bottle immediately after use IMPORTANT Do not reuse test strips Perform other levels of control solution testing by repeating the above steps ...

Page 33: ...Make sure you are usingWellion LEONARDO Glucose Control Solution Level 0 Level 1 and Level 2 orWellion LEONARDO Cholesterol Control Solution Level 1 Level 2 Make sure the testing environment is between 5 C 45 C for glucose test or between 18 C 38 C for cholesterol test Check the expiration and opened date on bottles of both control solution and test strip Repeat the test using a new test strip If ...

Page 34: ... testing site thoroughly with soap and warm water and dry well You are testing in an area between the temperature ranges of 5 C 45 C Your meter will not test outside of this range and will display the temperature icon Move the meter into an area that is between 5 C 45 C and let it sit for 10 to 15 minutes before testing again Ifthemeterisbeingoperatedbyasecondpersonwhoisprovidingtestingassistance ...

Page 35: ...Dispose of used lancets properly in biohazardous waste If alcoholic wipes are used to cleanse the fingers make sure the area is dry before the blood sample is obtained Step 1 Wash the puncture site with soap and warm water and dry thoroughly Warm water stimulates blood flow making it easier to obtain a sample Step 2 Hang the arm down at the side for 10 to 15 seconds massaging through the wrist pal...

Page 36: ...ting on the adjustable cap for the puncture depth level 1 is the lightest and 10 is the deep est Step 6 With one hand holding the lancing device pull back the cocking handle with your other hand until you hear a click sound and the lancing device is ready The release button should now be coloured red to indicate the lancing device is ready for blood sampling If the release button is not red pull t...

Page 37: ...Alternative site testing can be less painful than fingertip testing but because of the physiological difference between your fingertip and palm and forearm1 AST result may be significantly different than results from fingertip testing under certain conditions You should consult with your doctor or healthcare professional before using AST DO AST ONLY in the following intervals In a pre meal or fast...

Page 38: ...car You are sick You think your blood glucose is low Your AST results do not match the way you feel You are testing for hyperglycemia Your routine glucose results are often fluctuating Consult with your healthcare professional to decide if AST is right for you 1 Shu M Osamu F Kazuhiro H Yoshihito A Hypoglycemia Detection Rate Differ s Among Blood Glucose Monitoring Sites Diabetes Care 28 3 708 709...

Page 39: ...hich is printed on the test strip bottle Use each test strip immediately after removing it from the bottle Do not use wet or damaged test strips Keep away from direct sunlight and heat XXX Store the test strips in a dry cool place Record the date opened on the bottle label Discard the bottle and any remaining test strip after 6 months from date of opening Insufficient blood specimen may cause inco...

Page 40: ...ncture site on forearm or palm Avoid veins hair moles bone and tendon For palm testing it is not necessary to rub the skin or pump the device Press the lancing device firmly against the puncture site and then press the release button For forearm testing only rub testing area vigorously until it feels warm to increase blood flow Press the lancing device firmly against the puncture site and then pre...

Page 41: ...our glucose testing result will appear on the meter display screen Step 6 Select the before after meal marker With the test result on the display and the test strip STILL IN THE METER you can now choose if you want the result to be stored without any marker or with one or more markers Press the arrow buttons to select XXX before meal marker XX after meal marker or IMPORTANT If results from AST do ...

Page 42: ...n XX appears on the screen Use the arrow buttons to select the marker or remain blank Press OK to confirm your choice and the result will be stored in memory Step 9 Remove the used test strip either by pushing the eject button if available or by pulling it out with your hand The meter will turn off automatically The meter will also time out after 2 minutes of inactivity Step 10 Remove the used lan...

Page 43: ...ed your blood glucose level may be beyond the meter measurement range above 33 3 mmol L 600 mg dL or below 1 1mmol L 20 mg dL Test again using fingertip blood DO NOT test on palm or forearm If you still receive the same result call your physician or healthcare professional immediately If you get a result of HI or LO it will be stored as 33 3 mmol L 600 mg dL or 1 1mmol L 20 mg dL in the meter memo...

Page 44: ...ater anddry well You are testing in an area between the temperature ranges of 18 C 38 C Your meter will not test outside of this range and will display the temperature icon Move the meter into an area that is between 18 C 38 C and let it sit for 10 to 15 minutes before testing again If the meter is being operated by a second person who is providing testing assistance to the user the meter and lanc...

Page 45: ...eal marker after meal marker Chol Chol MED TRUST Handelsges m b H Gewerbepark 10 7221 Marz AUSTRIA www wellion at www medtrust at W11 40ECW RevA 03 2016 0197 WELL11 00ECW MED TRUST Handelsges m b H Gewerbepark 10 7221 Marz AUSTRIA www wellion at www medtrust at W11 40ECW RevA 03 2016 0197 WELL11 00ECW IMPORTANT Do not use a test strip that has expired Check the expiration date XX which is printed ...

Page 46: ...e drop of blood at a slight angle The test strip acts like a straw to pull the blood in Keep the test strip in contact with the blood drop until the meter starts the countdown to indicate the test strip has enough blood to test Step 6 The screen will start to count down After 90 seconds your cholesterol testing result will appear on the meter display screen AB 000000 AB 000000 CHOL CHOL MED TRUST ...

Page 47: ...ANT Usedlancetsandstripsarebiohazardousmaterialsandcantransmitblood bornediseases Please follow your local healthcare provider s recommendation regarding proper disposal of used lancets Step 7 Remove the used test strip either by pushing the eject button if available or by pulling it out with your hand The meter will turn off automatically The meter will also time out after 2 minutes of inactivity...

Page 48: ...high or low blood glucose reading If the meter displays results that are HI or LO or you get a result that is more than your high or low blood glucose threshold value and you feel ill Treat your diabetes according to the instruction from your doctor and or consult with your healthcare provider Test your meter and strips with the control solution refer to the chapter Control Solution Testing Test a...

Page 49: ... may occur in severely hypotensive individuals or patients in shock Inaccurate low results may occur in individuals experiencing a hyperglycemic hyperosmolar state with or without ketosis Critically ill patients should not be tested ...

Page 50: ... symptoms people do not feel ill just by having high blood cholesterol Many people are totally unaware that their cholesterol level is too high therefore it is very important to keep a constant monitor of your cholesterol level Consult your physician about your blood cholesterol level Total cholesterol levels3 5 2 mmol L 200 mg dL Desirable 5 2 6 2 mmol L 200 239 mg dL Borderline High 6 2 mmol L 2...

Page 51: ...efore using the memory and day averaging function see the chapter Setting UpYour New System The meter will not memorize any test or control results if the date and time are not set Material you will need Your Wellion LEONARDO GLU CHOL plus Meter Step 1 Turn on the meter by pressing and holding the OK button until the screen shows mem When Glu is flashing press OK to confirm your choice Step 2 The ...

Page 52: ...lts with date and time You will need to set your meter date and time before using the memory see the chapter Setting Up Your New System The meter will not memorize any test or control results if the date and time are not set NOTE Control testing results will be flagged by a Ctl icon When the memory is full performing a new test will delete the oldest test result Control testing results will not be...

Page 53: ... screen Press the arrow up button to view your results from the most recent to the oldest After you finish viewing the memory either begin testing by inserting a test strip or press and hold OK to turn off the meter NOTE Control testing results will be flagged by a Ctl icon When the memory is full performing a new test will delete the oldest test result If you get a result of HI or LO it will be s...

Page 54: ...e upload feature should only be used with a DMS product that specifically identifies the Wellion LEONARDO GLU CHOL plus as a meter that is compatible with their DMS CARING FOR THE METER Caring for your Wellion LEONARDO GLU CHOL plus Meter is easy Follow these simple guidelines to keep your Wellion LEONARDO GLU CHOL plus Meter working properly Cleaning the Meter If the meter gets dirty use a moist ...

Page 55: ...ang es between 5 C and 45 C for glucose testing and between 18 C and 38 C for cho lesterol testing Avoid leaving the meter in extremely hot or cold places such as near a heat source or in an extremely hot or cold car Do not store or use the meter or test strips where they may be exposed to high hu midity levels such as in a bathroom or kitchen Always close the bottle cap immediately after removing...

Page 56: ... the significant display screen messages and error codes you may encounter when using your Wellion LEONARDO GLU CHOL plus Meter and Wellion LEONARDO Test Strips Message What It Means What You Should Do E 1 Used or contaminated test strip Remove the test strip and repeat the test with a new test strip Wait until you see the flashing blood drop icon before you add blood or control solution sample E ...

Page 57: ...10 to 15 minutes for it to reach the new temperature See the chapter Storage and Precautions E 5 Meter failure Replace the batteries and turn the meter on again Remove the test strip and insert a new test strip If problem persists contact your local distributor E 6 Expired cholesterol test strip Check if the date and time on your meter is set up See Setting the Clock Verify the expiration date of ...

Page 58: ... test using a new test strip If the result is still LO contact your physician or healthcare professional immediately HI with Chol symbol Cholesterol test result higher than 10 3 mmol l 400 mg dL Wash and dry your hands and repeat the test using a new test strip If the result is still HI contact your physician or healthcare professional immediately LO with Chol symbol Cholesterol test result lower ...

Page 59: ...d time on your meter is set up See Setting Up Your New System Start testing your blood glucose or cholesterol see Testing Your Blood Glucose and Testing Your Cholesterol Temperature out of range Move the meter into an area that is between 5 C to 45 C for glucose test or 18 C to 38 C for cholesterol test and allow 10 to 15 minutes for it to reach the new temperature GLU CHOL GLU CHOL Chol G Chol lu...

Page 60: ... i SN Storage 90 10 Storage 30 C 10 C Operation 45 C 0 C T O L C 4 F 39 C 30 F 86 D V I 2 i SN Storage 90 10 Storage 30 C 10 C Operation 45 C 10 C T O L C 4 F 39 C 30 F 86 D V I 2 i SN Storage 90 10 Storage 30 C 10 C Operation 45 C 10 C REF FOR SELF TESTING SYMBOLS EXP Expiration date use by the last day of the month LOT Batch Code Temperature Limitations Consult Instructions for Use In Vitro Diag...

Page 61: ...Time 5 seconds for glucose test 90 seconds for cholesterol test Calibration Plasma Blood Sample Size 0 5 μL for glucose test 3 6 μL for cholesterol test Hematocrit Range 10 70 for glucose 30 55 for cholesterol test Event marker Before After meal marker exercise marker medication insulin marker Warnings hypoglycemia and hyperglycemia warning underfill warning Display Type VA screen with back lighti...

Page 62: ...e test 85 for cholesterol test Alarms 3 for glucose test 3 for cholesterol test Storage Transport Condition Meter at 20 C to 50 C Glucose test strip at 4 C to 30 C Cholesterol test strip at 4 C to 30 C For additional information refer to the Wellion LEONARDO Blood Glucose Test Strip insert or Wellion LEONARDO Cholesterol Test Strip insert Classification according to IEC EN 61010 2 101 Electromagne...

Page 63: ...ts or in accordance with the manu facturer in replacement of the device The right to cancel the purchase applies only if the replacement goods are also faulty Other claims cannot be accepted Warranty by MED TRUST is limited to the repair or replacement of the device and in no case can MED TRUST be held responsible for any collateral or consequential damages or losses The warranty is invalidated by...

Page 64: ... MED TRUST Wellion and LEONARDO are registered trademarks W11 32CEN RevB 04 2017 In Vitro Diagnostic Medical Device MEDTRUSTHandelsges m b H Gewerbepark 10 7221 Marz AUSTRIA www medtrust at ...