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TRUST

, W

ellion and CALLA ar

e r

ist

ed trademarks

W932LENMGMM RevA 12/2017

In Vitro Diagnostic
Medical Device

MED TRUST Handelsges.m.b.H.
Gewerbepark 10
7221 Marz
AUSTRIA
www.medtrust.at

Содержание CALLA Light

Страница 1: ...OWNERS GUIDE ...

Страница 2: ...uded in this manual Please read it carefully Your Wellion CALLA Light Blood Glucose Monitoring System provides an easy and precise way to measure blood glucose using fresh capillary whole blood taken from fingertips palm or forearm Testing is done outside the body in vitro diagnostic use The test results are plasma calibrated for easy comparison to lab results The Wellion CALLA Light Blood Glucose...

Страница 3: ...g Up Your New System 11 Inserting or Changing Batteries 11 Setting Time and Date 13 Turning ON OFF Tone Sound 16 Hypo Hypoglycemia and Hyper Hyperglycemia Warning Setting 19 Setting Alarms 23 Control solution testing 26 Control Solution Trouble Shooting 30 Testing your blood glucose 31 Preparing your Lancing device 32 Performing a Blood Glucose Test 34 TABLE OF CONTENTS ...

Страница 4: ...Glucose Test Result 38 Viewing Stored Readings and 1 7 14 30 60 and 90 Days Average from Memory 40 Caring for the Meter 43 Cleaning the Meter 43 Storage and Precautions 43 Solving Problems 45 Manufacturer s Warranty 49 Specifications 50 Symbols 51 ...

Страница 5: ... The Wellion CALLA Light Blood Glucose Monitoring System kit includes the fol lowing items Wellion CALLA Light blood glucose meter 10 Wellion Lancets Compact Pouch Easy Start Guide User Guide Reference Guide UNDERSTANDING YOUR BLOOD GLUCOSE KIT ...

Страница 6: ... OK Button Press and hold to access the memo ry recall mode see page 43 or set up mode see page 11 View daily ave rage results when in memory recall mode see page 43 Press and enter to set up a specific function in setup mode see page 11 Press and hold to turn off the meter The correct reading of your data can be ensured only with the original Wellion CALLA USB cable with Micro USB connector Scrol...

Страница 7: ...7 Battery Compartment Holds two AAA batteries The Wellion CALLA Light Meter THE WELLION CALLA LIGHT METER ...

Страница 8: ...a referenced for easy comparison to lab results and has under fill detection to alert you when there is not enough blood to perform a test so you can be sure that each reading you get is an accurate and meaningful result THE WELLION CALLA BLOOD GLUCOSE TEST STRIP Contact Points Insert this end into the test strip port of the meter Sampling End Apply blood or con trol solution here IMPORTANT Be sur...

Страница 9: ...se Test Strips are sensitive to moisture and light it is important to close the vial cap of the test strip bottle tightly after each use DO NOT leave any test strips outside the bottle while not in use Carefully discard used test strips and lancets in proper waste containers ...

Страница 10: ...lid temperature icon Control solution mode icon Hour Minute Alarm clock setting icon Test strip icon Blood Control solution icon Low battery icon Day average icon Memory recall icon Year Month Date Hypo Hyper warning setting message Tone setting message Reading Countdown message Tone On Off message Error message ...

Страница 11: ...he battery icon appears on the meter display Materials you will need Your Wellion CALLA Light Meter Two Alkaline AAA Batteries Supplied in Kit Step 1 Unhook the hinge on the battery cover Step 2 Insert new batteries according to the direction found on in side the battery compartment Place the battery cover back into the meter firmly INSERTING OR CHANGING BATTERIES ...

Страница 12: ...ll be memorized by the meter for appro ximately 5 minutes If the batteries are inserted after 5 minutes meter may prompt to verify the current date and time see page 13 Setting Time and Date The stored results and settings will not be erased when the batteries are being changed ...

Страница 13: ...plays FunC Step 2 Release the OK button and the meter will light up showing all its segments Thecurrentdateandtimewillflash Iferrormessages E 1 E 2 etc appear see page 45 Solving Problems SETTING TIME AND DATE NOTE If date and time on the Wellion CALLA Light Meter has not been set test or control results will not be stored in the meter memory ...

Страница 14: ...OK button to confirm your choice and advance to set the day Step 4 Set Day The current day will flash Use or buttons to select the correct day Press the OK button to confirm your choice and to advance to set the year Step 5 Set Year The current year will flash Use or buttons to select the correct year Press the OK button to confirm your choice and to advance to set the hour ...

Страница 15: ...K button to confirm your choice and to advance to set the minutes Step 7 Set Minute The current minute will flash Use or buttons to select the correct minutes Press the OK button to confirm your choice and the result of your date and time correction will flash as a whole Press button to select the next function to setup or insert a test strip and begin testing You can also turn off the meter by pr...

Страница 16: ...ages Material you will need Your Wellion CALLA Light Meter Setting the tone after finishing setting up date and time Step 1 After confirming your date and time set up by following the in structions in the previous section press button to select tone set up The tonE icon will flash and the current tone status will display on the LCD screen Step 2 Press the OK button to enter tone setup Use or butto...

Страница 17: ...test strip and begin testing You can also turn off the meter by press and hold the OK button until the display screens shows OFF Setting the tone when the meter is turned off Step 1 Press and hold the OK button until the display screen displays FunC Step 2 Release the OK button and the meter will light up showing all its segments The current date and time will flash If error messages Err 1 Err 2 e...

Страница 18: ...memorized by the meter Step 3 Press button go to tone set up and press the OK button to enter tone setup Use or buttons to turn the tone on or off Step 4 Press or button to select the next function to setup or insert a test strip and begin testing You can also turn off the meter by press and hold the OK button until the display screens shows OFF ...

Страница 19: ... will need Your Wellion CALLA Light Meter HYPO AND HYPER WARNING SETTING IMPORTANT For your convenience the factory preset Hypo alarm Hypoglycemia is 70 mg dl 3 9 mmol l and the factory preset Hyper alarm Hyperglycemia is 250 mg dl 13 9 mmol l Consult your physician or caregiver before attempting to adjust or set up the Hypo Hyper warning on this meter and ALWAYS follow your physician or caregiver...

Страница 20: ...he hypo icon will flash and the current hypoglycemia warning value will display on the LCD screen Step 2 Press the OK button to enter hypo setup Press or buttons to once adjust the values one by one or press and hold or buttonstoadvancethrough the numbers very quickly The Wellion CALLA Light Meter has a settable Hypo range from 0 to 127 mg dl 0 to 7 mmol l Step 3 Press the OK button to exit Hypo s...

Страница 21: ...rent hyperglycemia war ning value status will display on LCD screen Step 2 Press the OK button to enter hyper setup Press or buttons to once adjust the values one by one or press and hold or buttons to advance through the numbers very quickly The Wellion CALLA Light Me ter has a settable Hyper range from 0 to 511mg dl 0 to 28 4 mmol l Step 3 Press the OK button to exit Hyper setup once confirmed ...

Страница 22: ...meter by press and hold the OK button until the display screens shows OFF To set up Hypo Hyper warning when the meter is off turn on the meter and enter setup mode by pressing and holding the OK button until the meter display screen shows FunC Navigate the menu using the or buttons and follow the corre sponding steps from the above section to setup the warning ...

Страница 23: ...setup up your alarms Material you will need Your Wellion CALLA Light Meter Step 1 Press or buttons in the Function menu until a bell icon flashes Step 2 Press the OK button and enter alarm setup Step 3 The number 1 will flash This indicates the first alarm setup Press the OK button to enter setting up the first alarm or press or buttons to see additional options ...

Страница 24: ...o turn the alarm ON or OFF Press the OK button to confirm your selection Step 5 With ON selected begin setting alarm by first setting the hour by pressing or buttons After setting the desired hour press the OK button and enter to set the minutes Press or buttons to set the minutes and press the OK button to confirm selection The screen will now return to the alarm setting menu ...

Страница 25: ...on to scroll through the numbers quickly Step 6 Press or buttons to set up the next alarm s There are three alarms which can be set Follow steps 3 through 5 to set the additional alarms After finishing setting up the alarms press or buttons to End selection to exit alarm setting ...

Страница 26: ...and test strips are not working properly The blood glucose test results do not reflect how you feel You practice the testing procedure CONTROL SOLUTION TESTING IMPORTANT Use only the Wellion CALLA Glucose Control Solutions with the Wellion CALLA Test Strips Other brands of control solution will produce inaccurate results Always check the expiration date DO NOT use control solutions if expired Mark...

Страница 27: ...immediately after taking out a strip CONTROL SOLUTION TESTING IMPORTANT Do not use test strip that has expired Check the expiration date that is printed on the test strip bottle and its package 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 Store the test strip bottle in a dry cool place Record the dat...

Страница 28: ...ce the bottle cap on the control solution bottle immediately after use Step 4 While holding the meter touch the control solution to the edge of the test strip and the control solution would be automatically sipped into the reaction area of the test strip Hold the meter until it beeps Make sure you are testing between 10 C 40 C If the Meter displays move the meter into an area that is between 10 C ...

Страница 29: ...t strip bottle see Control Solution Solving Problems on page 45 Step 7 Remove and discard the used test strip into proper waste bas ket The meter will automatically shut off after the test strip has been removed or will shut off after 2 minutes of nonuse Perform other levels of control solution testing by repeating the above steps NOTE Control solution testing results will be stored in the meter m...

Страница 30: ... tempe rature Expired or contaminated control solution Damaged test strip Meter malfunction Make sure you are using Wellion CALLA Control Solution Make sure the testing environment is between 10 C to 40 C Check the expiration and open bottle date on all control solution and test strips Repeat testing using a new test strip If the result is still out of range use a new bottle of control solution an...

Страница 31: ... sure Set up your meter properly and run a control test See Setting Up Your New Sys tem on page 11 and Control Solution Testing on page 26 for details Wash your hands and testing site thoroughly with soap plus warm water and dry well You are testing in an area between the temperature ranges of 10 C to 40 C Your meter will not test outside of this range and will display Make sure that you perform t...

Страница 32: ...ush down firmly until it is fully seated Step 2 Twist the protective cover off from the lancet Twist clock wise the adjustable cover back onto the lancing device NOTE For fingertip testing use the adjustable cap Lancet Holder Lancet Ejection System Release Button 1 Shallow Deep 2 3 4 5 6 7 8 9 10 Sliding Barrel Adjustable Tip Penetration Depth ...

Страница 33: ...r a click sound and the lancing device is ready The release button is now colored red so you can easily verify if the lancing device is ready for blood sampling If the release button is not read pull the cocking handle again until the release button changes the color to red IMPORTANT Use a new sterile lancet every time you test to avoid cross contamination If alcohol wipes are used to cleanse the ...

Страница 34: ...ck the expiration date printed on the test strip bottle and its package Do not use expired test strips 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 Store the test strip bottle in a dry cool place Record the date opened on the bottle label Discard the bottle and any re maining test strip after 6 month...

Страница 35: ... at a slight angle The test strip acts like a straw to pull the blood in Keep the test strip in the blood drop until the meter beeps to indicate the test strip has enough blood to test TIP Gently message your hand and finger toward the puncture site to form a drop of blood Do not milk or squeeze around the puncture site Lance the side of your fingertip to avoid soreness To avoid calluses choose a ...

Страница 36: ...in using finger tip testing DO NOT test on forearm If you still receive the same result call your physician or healthcare professional immediately Step 5 The meter display screen will flash before meal after meal marker Select the pro per marker according to the time of testing by pressing or buttons Press the OK button to confirm selection If no markers are selected then the me ter will memorize ...

Страница 37: ... lancing device You can use the lancet ejector to prevent needlestick injuries Push the lancet ejector forward with the thumb and simultaneously pull out the sliding barrel to dispose of the used lancet Discard the lancet into proper wastebasket TESTING YOUR BLOOD GLUCOSE Wählen Sie einen Marker Nach dem Essen Marker Kein Marker Vor dem Essen Marker ...

Страница 38: ...than 140 mg dl 7 8 mmol l after meal1 It is important to consult with your physician or healthcare professional to deter mine an appropriate target range for you What to do if you get a high or low reading If the Meter displays results that are marked with hypo or hyper this means that your results are below or above your chosen hypo or hyper limit AND you feel ill IMPORTANT Discard used test stri...

Страница 39: ...your chosen hypo or hyper limit AND you DO NOT feel ill Test your meter with a control solution refer to page 26 Control Solution Te sting Test again using fingertip or palm If you still get a high or low reading contact your health care professional Reference 1 American Diabetes Association Position Statement Standarts of Medical Care in Diabetes 2010 Diabetes Care 2010 33 Suppl 1 S11 S61 UNDERST...

Страница 40: ...trolling your blood glucose level You will need to set your meter date and time to use the memory and day averaging function see Setting UpYour New System on page 11 The meter will not memorize any test or control results if the date and time are not set Materials you will need Your Wellion CALLA Light Meter Step 1 Turn on the meter by press and hold the OK button until the screen shows mem Step 2...

Страница 41: ... no recorded test results in the me mory Step 3 Press the OK button to enter viewing daily averages The first average will be the 1 day average Press or but tons to scroll through 7 14 30 60 and 90 days averages Step 4 Press and hold the OK button to turn the meter off when finished or insert a test strip to begin testing VIEWING YOUR METER S MEMORY ...

Страница 42: ...ill not be included in the day averages When there are no daily average data available the display screen will show 3 dashes If the memory already has 500 test results adding a new test result will cause the oldest one to be deleted Memorized test results and daily averages will not be erased when changing batteries VIEWING YOUR METER S MEMORY ...

Страница 43: ...ed with a mild detergent Do not get water inside the CALLA Light Meter Never immerse 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 Storage and Precautions Handle the Meter with care severe shock such as dropping the meter could damage the electronics The meter and test strips are designed to be used within the...

Страница 44: ...Do not store or use the meter or test strips in high humidity levels such as ba throom or kitchen Always close bottle cap immediately after removing a test strip and make sure it s closed tightly Do not take the meter apart Doing so will void the warranty If there are techni cal problems or questions call our authorized dealer for assistance ...

Страница 45: ...and error codes you will encounter when using your Wellion CALLA Light meter and test strips What you see What it means What should you do Test strip failure Damaged wet or already used Insert a new test strip into the meter Not enough blood Insert a new test strip into the meter and repeat testing ...

Страница 46: ...ontact your authorized distributor Extreme conditions Big temperature dif ference Move the meter into an area that is between 10 C to 40 C and allow 10 to 15 minutes for it to reach the new temperature The meter is dama ged Replace the batteries and turn on the meter again If problem persists contact your authorized distributor ...

Страница 47: ...of operating tempe rature Move the meter into an area that is between 10 C to 40 C and allow 10 to 15 minutes for it to reach the new temperature Test result is higher than 600 mg dl 33 3 mmol l 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 immedia tely ...

Страница 48: ...ult is low er than 20 mg dl 1 1 mmol l Treat low blood sugar immediately Wash and dry your hands and repeat the test using a new test strip If the result is still LO contact your physi cian or healthcare professional imme diately ...

Страница 49: ...arts or at the discretion 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 warranty is not valid if the damage results from misuse maltreatment tampe ring human error and the use of extreme This warranty is valid only if the date the stamp ...

Страница 50: ... LCD screen Memory 500 blood test results with date and time Result Averaging 1 7 14 30 60 and 90 days averaging Dimension 69 6 x 62 6 x 23 mm Weight 68g incl batteries Battery 2 Alkaline AAA Batteries Battery Life 1000 tests of continuous use or 1 year Automatic Power off After 2 minutes of nonuse Operating Temperature 10 C to 40 C Relative Humidity Less than 85 Storage Condition Meter at 20 C 60...

Страница 51: ...Code Temperature Limitations Consult Instructions for Use In Vitro Diagnostic Medical Device Caution consult accompanying documents Catalogue number Keep away from sunlight direct light Do not reuse Do not use if package is damaged Keep dry Manufacturer In vitro diagnostic medical device for self testing T O L i 2 D V I REF FOR SELF TESTING Software Version RDM0037 004 01 Rev 1 01 C 4 F 39 C 30 F ...

Страница 52: ... MED TRUST Wellion and CALLA are registered trademarks W932LENMGMM RevA 12 2017 In Vitro Diagnostic Medical Device MEDTRUSTHandelsges m b H Gewerbepark 10 7221 Marz AUSTRIA www medtrust at ...

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