Wellion LEONARDO GLU/CHOL plus Owner's Manual
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Wellion LEONARDO GLU/CHOL plus Owner's Manual

Blood glucose and cholesterol monitoring system
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OWNER'S
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Summary of Contents for Wellion LEONARDO GLU/CHOL plus

  • Page 1 OWNER‘S GUIDE...
  • Page 2 Dear Wellion LEONARDO GLU/CHOL (plus) Owner, Thank you for choosing the Wellion LEONARDO GLU/CHOL (plus) Blood Glucose and Cholesterol Monitoring System to help you easily monitor your blood sugar level and cholesterol level. The Glucose mode is auto-coding that does not require you to code the meter before use.
  • Page 3 INTENDED USE The Wellion LEONARDO GLU/CHOL (plus) Blood Glucose and Cholesterol Monitoring System is intended to quantitatively measure blood glucose in fresh capillary whole blood drawn from fingertips, palm, or forearm, and cholesterol in capillary whole blood from fingertips. Alternative site testing for glucose test should be performed only during steady-state (when glucose is not changing rapidly).
  • Page 4 YOUR NEW MEASURING KIT The Wellion LEONARDO GLU/CHOL (plus) measuring 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...
  • Page 5 Code Card Port Insertion site for the Battery Compartment cholesterol code card. Holds 2 x CR2032 3V lithium coin cell batteries The correct reading of your data can be ensured only with the original Wellion LEONARDO USB cable.

  • Page 6: Meter Display Screen

    Meter Display Screen Time - indicates the time. Medication/Insulin Marker - displayed when marking a result as being near to hypo warning - medication/insulin intake, or displayed when: viewing a marked result. • Setting up your hypoglycemic threshold value • Indicates your test result when at or below your hypoglycemic threshold value Date - indicates the date (dd/...
  • Page 7 mem - indicates the meter is in memory recall AVG - displayed when viewing mode and the number on the main display the 1, 7, 14, 30, 60 and 90 day area is a memorized testing result averages. This is for glucose values only Main Display Area - Battery Symbol - Lights up to...
  • Page 8 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.
  • Page 9 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. • The Wellion LEONARDO Cholesterol Test Strips are sensitive to moisture and light XXX. Test strip should be used within 10 minutes after removing from the aluminum foil package.
  • Page 10 SETTING UP YOUR NEW SYSTEM Inserting (or Changing) the Batteries The batteries need to be inserted before using your Wellion LEONARDO GLU/CHOL (plus) Meter for the first time or when the battery icon XXXX appears on the meter display screen.
  • Page 11 Remove the batteries if you are not going to use the meter for a long time. Setting the Clock 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“.
  • Page 12 Step 2: Release the OK button and the meter will show the current date and time. If you are setting the date and time for the first time, the month will now start flashing to indicate you are in date and time set-up mode. If you are changing the date and time, “SEt“...
  • Page 13 buttons to select the correct year. Press the OK button to confirm your choice and advance to set the hour. Step 6 - Set Hour: The current hour will flash. Use the arrow buttons to select the correct hour. Press the OK button to confirm your choice and advance to set the minute.
  • Page 14 • The Wellion LEONARDO GLU/CHOL (plus) Meter comes with Hypo/Hyper warning ON as preset, and the preset threshold value is 10 mmol/L (180 mg/dL) for Hyper and 3.9mmol/L (70 mg/dL) for Hypo. Follow the steps below to adjust the Hyper and Hypo threshold...
  • Page 15 Material you will need: Your Wellion LEONARDO GLU/CHOL (plus) Meter G l u Step 1: With the meter turned off, press and hold the OK button 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“.
  • Page 16 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”.
  • Page 17 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 default setting for all alarms is off. You must set the clock before you can set the alarms.
  • Page 18 Chol Material you will need: Your Wellion LEONARDO GLU/CHOL (plus) Meter Step 1: With the meter turned off, press and hold 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“.
  • Page 19 Step 4: The display screen will indicate the alarm 1 status (the default is OFF). You can turn it on by pressing OK and then G l u G l u G l u G l u choosing the desired setting with the arrow buttons. Step 5: Press OK and the hour will flash.
  • Page 20 • 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 on the test strip foil. • Make sure the code card is securely lodged into the code card port on the backside of the meter.
  • Page 21 Step 1: Locate the code card in the pack- age of Wellion LEONARDO Cholesterol AB 000000 Test Strips. Code Step 2: Verify that the code number on the WELL10-00ECW 0197 MED TRUST Handelsges.m.b.H. Gewerbepark 10 7221 Marz, AUSTRIA www.wellion.at www.medtrust.at code card matches the code number on the test strip package.
  • Page 22 All three sets of numbers should be the same. IMPORTANT • The code card found in the Wellion LEONARDO Cholesterol Test Strip package is for use with that particular package only. Different packages of Wellion LEONARDO Cholesterol Test Strips and other brands of test strips will produce inaccurate results.
  • Page 24 CONTROL SOLUTION TESTING Performing a Glucose Control Solution Test The purpose of glucose control solution testing is to validate the performance of the Wellion LEONARDO GLU/CHOL (plus) Blood Glucose and Cholesterol Monitoring System using the testing solution with a known range of glucose. Control solutions are sold separately.
  • Page 25 IMPORTANT • Use only the Wellion LEONARDO Glucose Control Solution (Level 0, Level 1 and Level 2) with the Wellion LEONARDO Blood Glucose Test Strip. Other brands of control solution will produce inaccurate results. W11-40ECW Rev A 03/2016 W11-40ECW Rev A 03/2016 •...
  • Page 26 Step 4: Squeeze a drop of glucose control solution (Level 0, Level 1 or Level 2) onto a clean, dry, non-absorbent surface. Do not apply control solution to the test strip directly from the bottle. Replace the bottle cap on the control solution bottle immediately after use.
  • Page 27 Step 5: Hold the meter and touch the control solution to the edge of the sampling end G l u of the test strip. The control solution will be automatically drawn into the reaction area of the test strip. Step 6: The screen will begin to count down. After 5 seconds, the control solution testing result will appear on the meter display screen.
  • Page 28 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 LEONARDO GLU/CHOL (plus) Meter and Wellion LEONAR- DO Cholesterol Test Strips are not working properly •...
  • Page 29 Your Wellion LEONARDO GLU/CHOL (plus) Meter A new Wellion LEONARDO Cholesterol Test Strip IMPORTANT • Use only the Wellion LEONARDO Cholesterol Control Solution (Level 1 or Level 2) with the Wellion LEONARDO Cholesterol Test Strip. Other brands of control solution will produce inaccurate results. •...
  • Page 30 W11-40ECW Rev A 03/2016 W11-40ECW Rev A 03/2016 IMPORTANT • Do not use a test strip that has expired. Check the expiration date which is printed on CHOL the test strip foil. • Use each test strip immediately after removing it from the foil. •...
  • Page 31 Step 5: Squeeze a drop of cholesterol control solution (Level 1 or Level 2) onto a clean, dry, non-absorbent surface. Do not apply control solution to the test strip directly from the bottle. Replace the bottle cap on the control solution bottle immediately after use.
  • Page 32 Perform other levels of control solution testing by repeating the above steps. NOTE • Control solution testing results will 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 •...
  • Page 33 • Wrong brand of • Make sure you are using Wellion LEONARDO Glucose control solution being Control Solution (Level 0, Level 1 and Level 2) or Wellion used LEONARDO Cholesterol Control Solution (Level 1, Level 2). • Make sure the testing environment is between 5°C-45°C •...
  • Page 34 TESTING YOUR BLOOD GLUCOSE Materials you will need: Your Wellion LEONARDO GLU/CHOL (plus) Meter A new Wellion LEONARDO Blood Glucose Test Strip Lancing device with a sterile, unused lancet Before you begin, make sure: • You set up your meter properly. See the chapter “Setting Up Your New System” for more details.
  • Page 35 Preparing your Lancing device CAUTION • Lancets are for single use only. Always use a new, sterile lancet each time you perform the test. • DO NOT share your lancing device or lancets with other people. Sharing or reusing lancets can lead to disease transmission.
  • Page 36 Step 3: Unscrew the adjustable cap of the lancing device and insert the lancet by pushing down firmly until it is fully seated. Step 4: Twist the protective cover off from the lancet. Replace the ad- justable cover back onto the lancing device. Step 5: Adjust the puncture setting on the adjustable cap for the puncture depth level (1 is the lightest and 10 is the deep- est).
  • Page 37 Important Information on Alternative Site Testing (AST) The Wellion LEONARDO GLU/CHOL (plus) Blood Glucose and Cholesterol Monitoring System can test blood glucose from sites other than your fingertip such as palm and forearm (alternative site testing, or AST).
  • Page 38 Alternative site measurements should never be used for insulin dosing calculations. AST SHOULD NOT be used when: • You have hypoglycemic unawareness (you are not able to tell if you have low blood sugar). • Within 2 hours of a meal, exercise, or medication. •...
  • Page 39 Performing a Blood Glucose Test Step 1: Take out a Wellion LEONARDO Blood Glucose Test Strip from the test strip bottle and close the bottle immediately. Insert the test strip to turn on the meter. W11-40ECW Rev A 03/2016 IMPORTANT CHOL •...
  • Page 40 Step 3 – Obtaining a blood sample: For Fingertip Testing: Hold the primed lancing device firmly against the side of your fingertip and press the release button to create a puncture. • Gently massage your hand and finger toward the puncture site to form a drop of blood. Do not “milk”...
  • Page 41 CHOL the release button. Keep the device in constant contact with the skin and apply and release pressure up and down 2–3 times without lifting device away from skin. When the blood is about the size of a pen tip lift the lancing device straight up without smearing the blood.
  • Page 42 Chol blank (= no meal marker). Press OK to confirm your choice and advance to select exercise marker. Chol Step 7 - Select the exercise marker: After selecting meal marker, a flashing exercise icon appears on the screen. Use the arrow buttons to select the exercise marker or remain blank. Press OK to confirm your choice and advance to select the medication/insulin marker.
  • Page 43 NOTE • “hypo” or “hyper” icons may appear on screen depending on the threshold limit you have set up - see the chapter “Setting Warning Values“. • The meter will turn off automatically when you pull the test strip out, or after 2 minutes of inactivity.
  • Page 44 TESTING YOUR BLOOD CHOLESTEROL Materials you will need: Your Wellion LEONARDO GLU/CHOL (plus) Meter A new Wellion LEONARDO Cholesterol Test Strip Lancing device with a sterile, unused lancet Before you begin, make sure: • You set up your meter properly. See the chapter “Setting Up Your New System“ for more details.
  • Page 45 “Setting Up Your New System“. CHOL Step 2: Take out a Wellion LEONARDO Cholesterol Test Strip from the test strip foil. Insert the test strip to turn on the meter. Step 3: The current code number will be displayed with a “Chol”...
  • Page 46 Step 4 – Obtaining a blood sample For fingertip testing: Hold the primed lancing device firmly CHOL against the side of your fingertip and press the release button to create a puncture. • The cholesterol test requires more blood than the glucose test so you may want to increase the puncture depth of the lancing device.
  • Page 47 CAUTION • If “HI” or “LO” is displayed, your cholesterol level may be beyond the meter measurement range - above 10,3 mmol/l (400 mg/dL) or below 2,6 mmol/l (100 mg/dL). Test again using fingertip blood. If you still receive the same result, call your physician or healthcare professional immediately.
  • Page 48 UNDERSTANDING YOUR TEST RESULTS Understanding Your Blood Glucose Test Results Blood glucose values will vary depending on food intake, medication, health, stress, and exercise. The ideal ranges for adults without diabetes are • less than 5,6 mmol/l (100 mg/dL) before meals •...
  • Page 49 IMPORTANT • Inaccurate results 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 Understanding Your Cholesterol Test Results High blood cholesterol is one of the major risk factors for cardiovascular disease. But high level of blood cholesterol does not cause 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.
  • Page 51 Viewing Stored Readings and 1-, 7-, 14-, 30-, 60-, 90- Day Averages of Glucose Test Results from Memory Your Wellion LEONARDO GLU/CHOL (plus) Meter can store up to 500 glucose test and control results with date and time. In addition, the meter also provides 1-, 7-, 14-, 30-, 60-, 90-day averages to help you better track your efforts in controlling your blood glucose level.
  • Page 52 Viewing Stored Readings of Cholesterol Test Results from Memory Your Wellion LEONARDO GLU/CHOL (plus) Meter can store up to 100 cholesterol test and control results 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”.
  • Page 53 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”. Then use the arrow buttons to see “Chol” and press OK to confirm your choice.
  • Page 54 Upload Data Insert the Wellion LEONARDO USB Cable into the data port. The “PC“ mode shows on the screen. Follow the Data Management System (DMS) instruction manual to upload data. For purchase information of DMS, please contact your local distributor.
  • Page 55 • Do not get water inside the Wellion LEONARDO GLU/CHOL (plus) Meter. Never im- merse the meter or hold it under running water. • Do not use glass or household cleaners on the meter. • Do not try to clean the test strip holder.
  • Page 56 • Dispose of the meter according to your local regulations for correct disposal. SOLVING PROBLEMS This section details 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...
  • Page 57 Test strip Repeat the test with a new test strip. See the removed during chapters “Testing Your Blood Glucose“ or “Testing countdown Your Blood Cholesterol“ Meter detects Move the meter into an area that is between 5°C extreme condition to 45°C for glucose testing or 18°C to 38°C for cholesterol testing and allow 10 to 15 minutes for it to reach the new temperature.
  • Page 58 Message What It Means What You Should Do Glucose test result Wash and dry your hands and repeat the test using (with Glu higher than a new test strip. If the result is still “HI”, contact your symbol) 33,3 mmol/l (600 physician or healthcare professional immediately.
  • Page 59 Message What It Means What You Should Do Low battery Change the batteries according to instructions for Inserting (or Changing) the Battery Chol No memorized • Check if the date and time on your meter is set up. results in the See “Setting Up Your New System“...
  • Page 60 SYMBOLS (EXP) Expiration date (use by the last day of the month) (LOT) Batch Code C ˚ C ˚ Temperature Limitations C ˚ F ˚ C ˚ C ˚ F ˚ C ˚ F ˚ F ˚ F ˚ F ˚ Consult Instructions for Use Storage Storage...

  • Page 61: Specifications

    Illuminated Test strip port: Method of measurement: Biosensor Test Strips: Wellion LEONARDO Blood Glucose Test Strip Wellion LEONARDO Cholesterol Test Strip Test Range: 1,1-33,3 mmol/l (20 - 600 mg/dL) for glucose test, 2,6-10,3 mmol/l (100 - 400 mg/dL) for cholesterol test...
  • Page 62 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 Electromagnetic Compatibility: This equipment complies with EMC requirement of EN 61326.
  • Page 63 MANUFACTURER’S WARRANTY The manufacturer warrants the Wellion LEONARDO GLU/CHOL (plus) blood sugar and cholesterol meter guarantee for material and manufacturing defects for a period of two years from date of purchase. This guarantee is lost when the device is not used as intended, has been poorly maintained or opened.
  • Page 64 MED TRUST Handelsges.m.b.H. Gewerbepark 10 7221 Marz In Vitro Diagnostic AUSTRIA Medical Device www.medtrust.at...

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