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NDP BETACHEK C50 User Manual

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Blood Glucose Monitoring System
User's Manual
Model C50 -1
EN
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Summary of Contents for NDP BETACHEK C50

  • Page 1 Blood Glucose Monitoring System User’s Manual Model C50 -1 Aim your phone camera at this QR code for video guides.

  • Page 2: Table Of Contents

    Contents Explanation of symbols ntended use Main features Getting to know your C50 Meter Meter set up Changing settings Preparing your lancing device Performing a blood glucose test Memory System tools Downloading results for analysis to an mobile app Checking your meter’s accuracy 10 Meter maintenance 11 Test and storage conditions 12 Symbols, problems and error messages...

  • Page 3: Explanation Of Symbols

    Explanation of symbols Manufactured by Expiry date This product fulfils the requirements of IVDR on 0123 in vitro diagnostic medical devices. In vitro diagnostic medical device Read instructions before use Storage temperature range Important information accompanies this product EC REP Authorised representative in the European Community Lot number Unique Device Identifier...

  • Page 4: Intended Use

    Intended use and Main features Intended use The BETACHEK C50 system is for the quantitative determination of glucose in ® fresh capillary blood, for the management of diabetes. Suitable for self-testing only. The meter may only be used for blood glucose testing by one person. There is a risk of infection being transmitted if the meter is shared with other people, or if health care professionals use the same meter for testing blood glucose in more than one person.

  • Page 5: Getting To Know Your C50 Meter

    1 Getting to know your C50 Meter Parts summary Sensor cover Lancet ejector Display Test cassette Sample/settings button 10 Thumbwheel Memory recall button 11 Battery cover Penetration depth selector 12 Lancing device cover Lancet holder 13 Penetration depth indicator Lancet 14 Sensor window...
  • Page 6 1 Getting know your C50 Meter System components • BETACHEK C50 Meter and battery ® • BETACHEK C50 Test Cassette ® • BETACHEK Control Solutions ® • BETACHEK Lancets ® Button functions Memory - recall test results and averages (sensor cover closed) Sample - fire the lancing device (sensor cover open) Settings menu (sensor cover closed) &...

  • Page 7: Meter Set Up

    2 Meter set up Checking the unit of measure Blood glucose results can be displayed in two different units of measurement (mmol/l or mg/dl). Your meter is factory set to display only one. This unit of measure can be checked during the: •...
  • Page 8 2 - Meter set up Inserting a test cassette A test cassette must be inserted before testing can begin. Test cassettes are sold separately. Important: Test cassettes must be used within 90 days of opening. Only remove a test cassette from its container when you are ready to insert it into the meter.
  • Page 9 2 - Meter set up Step 2 Insert test cassette When the insert cassette symbol is displayed, remove a cassette from the container and press it into position rounded end first. The test cassette should lock into place securely and lie flat in the meter.
  • Page 10 2 - Meter set up Test cassette expiry - 90 days from opening An unopened test cassette can be used until the expiry date printed on the container label or once loaded, the meter reads the test cassette ID number and starts a 90 day countdown for that cassette.

  • Page 11: Changing Settings

    3 Changing settings incl. time & date In order to properly understand test results you need to set the correct time and date. If the meter is paired to a mobile device, this is done automatically, so you may prefer to go straight to the pairing section.
  • Page 12 3 Changing settings Set time Minutes Month Step 2 24-hour format: Hours Minutes Hours 12-hour format: Hours Minutes am/pm Press M to set the time, or, press S to accept. Set date Step 3 Year Year Month Press M to set the date, or press S to accept.

  • Page 13: Preparing Your Lancing Device

    4 Preparing the lancing device Inserting a lancet The BETACHEK C50 meter has an ® integrated lancing device compatible with BETACHEK C50 Lancets. ® Important: The lancing device is intended for personal use only. It may only be used by one person for obtaining blood. If used by other people, there is a risk of infection being transmitted.
  • Page 14 4 - Preparing your lancing device Step 4 Close the lancet cover Press the lancet cover down and then slide it back until the cover is closed. Setting the penetration depth To produce virtually pain free sampling, you can set the penetration depth to one of 10 settings;...
  • Page 15 4 - Preparing your lancing device Removing a lancet Open cover Step 1 Push the curved grips as shown and slide the cover away from the meter. It will then spring open. Eject lancet Step 2 Pull the green lancet ejector out (1 cm) until the lancet comes out of the lancet holder.

  • Page 16: Performing A Blood Glucose Test

    5 Performing a blood glucose test Preparation You need a BETACHEK C50 Meter with cassette and lancet loaded. (See ® previous sections for details on how to load a cassette and lancet). Wash your hands with warm soapy water. This removes traces of glucose from your hands that may contaminate the test sample and increases blood flow to your fingers to make it easier to obtain a blood drop...
  • Page 17 5 - Performing a blood glucose test Test procedure Step 1 Open sensor cover Slide sensor cover in the direction of the arrow. The meter will turn on and run a numeric display check. Check that all the segments are functioning correctly as shown below. mg/dL meter mmol/L meter...
  • Page 18 5 - Performing a blood glucose test The meter will then display the number of tests remaining. Step 2 Wind on test Next the meter will flash arrows in a circle, this indicates the thumbwheel should be turned. Before blood can be applied, a test zone needs to be Thumbwheel moved into position.
  • Page 19 5 - Performing a blood glucose test Turn the thumbwheel in the direction of the flashing arrow to bring a test into position. If the thumbwheel is turned in the wrong direction a loud clicking noise will be heard. There is no harm caused to the meter if this occurs.
  • Page 20 5 - Performing a blood glucose test The meter will then display a flashing blood drop symbol. • Do not apply blood before the blood drop symbol is displayed. Doing so will waste a test. Step 3 Obtain a blood sample Press your finger firmly against the tip of the lancing device.
  • Page 21 5 - Performing a blood glucose test Note: You have approx. 2 minutes after the blood drop symbol appears to apply blood to the test zone. If you do not apply blood in this time, the meter will turn itself off. Close and open the sensor cover to restart. Step 4 Apply blood •...
  • Page 22 5 - Performing a blood glucose test Step 5 Result The meter will display the result with the time and date. The result will automatically be saved to memory. Do not close the sensor cover if you want to attach mg/dL meter mmol/L meter a flag to your result.
  • Page 23 5 - Performing a blood glucose test Step 7 Wind off used test 5 seconds after your result is displayed or a flag is selected, the wind symbol is displayed. mg/dL meter mmol/L meter Turn the thumbwheel to move the used test into the used test storage compartment of the cassette.
  • Page 24 5 - Performing a blood glucose test Flagging results You can flag test results to help you spot blood glucose trends for certain activities and to help describe an event connected with the result. You can only flag a result whilst it is still being displayed after the test. Symbol Description Before meal: Indicates a test performed before a meal.
  • Page 25 5 - Performing a blood glucose test Setting the after meal test reminder If you select the after meal test reminder in the flag menu, you will be prompted to set a time for your test reminder. mg/dL meter mmol/L meter Press the M button to change between 1 and 2 hour test reminder time options.

  • Page 26: Memory

    6 Memory Recalling saved test results The BETACHEK C50 meter stores 500 test results along with the time and ® date. The meter automatically stores the result in memory each time a test is performed. If 500 results are already stored, then the oldest result is deleted to make space for the newest result.
  • Page 27 6 - Memory Recalling averages Note: Time and date must be set to use this function. The C50 meter can calculate averages from the saved test results for 7, 14, 30 or 90 days. To enter the memory function (saved test results), press and hold the M button with the sensor cover closed.

  • Page 28: System Tools

    7 System tools The System Tools menu allows you to: • Perform a display check, • Check your meter’s firmware version number, • Check the number of tests remaining on the cassette, and • Check the number of days remaining until casette expiry. Note: The number of tests remaining and the number of days remaining can only be checked if you have a cassette inserted in the meter.
  • Page 29 7 - System Tools Checking the display Display check - release buttons S & immediately Check the LCD screen periodically to ensure all segments are being correctly displayed. Press and hold the S and M buttons for approx. 3 seconds with the sensor cover closed. The meter will mg/dL meter perform a display test by lighting up all the segments of the LCD screen.
  • Page 30 Number of tests remaining S & The Betachek C50 Meter can automatically track the number of tests left on the test cassette. With the cassette inserted in the meter, press and hold the S and M buttons for approx. 3 seconds with the sensor cover closed. This will run a display check (release the buttons when the LCD segments are displayed).

  • Page 31: Downloading Results For Analysis To An Mobile App

    8 Downloading results for Analysis Downloading results for analysis The BETACHEK Diabetes Management App is free software for Apple iPhones and iPads . Download it from ® ® ® the App Store onto your device. Results are automatically uploaded to your iphone or ipad, where the BETACHEK diabetes management app creates ®...
  • Page 32 8 - Downloading results for analysis Pairing the BETACHEK C50 meter with your device The Betachek C50 Meter allows you to wirelessly synchronise your saved test results with a mobile device. This is done via bluetooth connection between your meter and mobile device.
  • Page 33 Hold down the S and M buttons on the meter until the bluetooth symbol appears. d. Ensure the mobile device and the Betachek C50 meter are less than 1 metre apart. e. Open the app and follow pairing instructions...

  • Page 34: Checking Your Meter's Accuracy

    Read the package insert which comes with the control solutions. For a control test, you need: • Betachek C50 Meter • Betachek C50 test cassette • Betachek Control Solution 1 (low glucose concentration) or Betachek Control Solution 2 (high glucose concentration)
  • Page 35 9 - Checking your meter’s accuracy Performing a control test Note: Control Solution contains a specific amount of glucose. If the cap is left off the control solution bottle, water can evaporate and the glucose concentration can increase. Similarly, when control solution wets the inside of the cap after use, it dries and leaves glucose that contaminates the tip of the bottle.
  • Page 36 9 - Checking your meter’s accuracy Step 2 Turn on the meter Slide the sensor cover in the direction of the arrow. This will turn the meter on and run a numeric display check by lighting up the numeric segments and meter unit of measure.
  • Page 37 9 - Checking your meter’s accuracy Step 3 Wind on a test zone Turn the thumbwheel in the direction of the flashing arrow to bring a test into position. The meter will sound a beep (if sound on) and display "OK" when a test zone is in position.
  • Page 38 9 - Checking your meter’s accuracy When the control solution has been applied, the meter will sound a beep (if sound on) and commence measuring. The flashing hourglass symbol indicates when the test is underway, until a result is displayed. Test results will be displayed in approx.
  • Page 39 9 - Checking your meter’s accuracy Your meter will automatically check if the control test result is within the acceptable ranges. Additionally, you can check the result against the acceptable ranges printed on the Test Cassette bottle label. If the control test result is within the acceptable ranges, the meter will Control test Control test...
  • Page 40 9 - Checking your meter’s accuracy Possible sources of error If the result of the control test is outside the specified concentration range, repeat the control test. If the result of the second test is also outside the specified concentration range, check the following points. •...

  • Page 41: Meter Maintenance

    10 Meter maintenance The meter must be kept clean and stored safely away from water, moisture (<85% humidity), extremes of heat or cold and dust. Avoid getting blood on the meter. If you do, cleaning the meter is necessary. (E-4, E-5, E-9, E-12) Cleaning your meter Notes on cleaning your meter: •...
  • Page 42 10 - Meter Maintenance Step 2 Cleaning the cassette bay If the cassette bay is visibly dirty, clean the area with a lightly moistened tissue or cotton swab/tip. Step 3 Cleaning the sensor window Clean sensor window with a damp cotton tip or tissue in the direction shown.
  • Page 43 10 - Meter Maintenance Cleaning the lancing device Dampen a tissue with water. Wipe the exterior and interior of the lancing device. Do not immerse in any liquids. Dry the lancing device with a dry tissue. Disinfecting Wipe the lancing device thoroughly with a tissue dampened with 70% isopropanol.
  • Page 44 10 - Meter Maintenance Note: • Only remove the battery when the meter is turned off. • Remove the battery if you will not be using the meter for a long time. Warning: Keep out of reach of children. Swallowing a coin battery can cause •...

  • Page 45: Test And Storage Conditions

    11 Test and storage conditions Temperature Make sure that the following conditions are met so that the meter and lancing device operate reliably and you obtain accurate results. Testing • For blood glucose tests and control solution tests the temperature must be +10°C to +40°C (+50°F to +104°F).
  • Page 46 11 - Test and storage conditions Storage • Meter without battery and cassette:-25°C to 70°C (-13°F to 158°F). • Meter with battery, without cassette: -20°C to +50°C (-13°F to +158°F). • Meter with battery and cassette: +2°C to +30°C (+35.6°F to +86°F). Note: •...

  • Page 47: Symbols, Problems And Error Messages

    12 Symbols, problems and error messages Symbols Symbol Meaning Additional time information if 12-hour time format is set. Bluetooth symbol. Flashes when trying to connect. The alarm bell symbol. The unit of measure. Factory set to mg/dL OR mmol/L. Low battery warning. You can perform approx. 50 more tests. You are in the Memory Menu for test results and averages.
  • Page 48 12 - Symbols, problems and error messages Symbol Meaning Meter symbol. Close sensor cover. You are in the Settings Menu for time format, time, date and sound. Hourglass symbol. A test is underway. Blood drop symbol. You can now apply blood or control solution to the test zone.
  • Page 49 12 - Symbols, problems and error messages Problem and possible causes Solution to the problem E-4, E-5, E-9, E-12 Sensor window dirty Remove cassette and clean sensor. Use a larger drop or press down on Blood did not cover red light drop to spread it.
  • Page 50 12 - Symbols, problems and error messages Error messages When an error occurs, look up the meaning of the error message and correct the issue so the error is not repeated. Do not apply bood until you get a blood drop symbol or a test will be wasted. E-0: Bluetooth error The meter was unable to pair with a device.
  • Page 51 12 - Symbols, problems and error messages E-5: Meter Dirty or Too much ambient light Remove the cassette and clean the sensor window. The meter is exposed to too much light. Go to a shaded place or shade the meter. E-6: Test zone wound too far.
  • Page 52 12 - Symbols, problems and error messages E10: Insufficient battery power There is insufficient battery power to perform a test. Replace the battery. See section Replacing the battery. E11: Temperature warning The temperature is at the limit of the permitted testing range You can still perform a blood glucose or control solution test,however, it is recommended that you allow the meter to cool down or heat up to be within the permitted temperature range...

  • Page 53: Technical Data

    13 Technical data Meter name Betachek ® For self testing of blood glucose. Not suitable for multi Intended use patient testing. Integrated lancing Single patient use only, 10 penetration depths device Lancet: Betachek lancets ® Test time Approx. 5 seconds Measuring method Reflex photometry Test Principle...
  • Page 54 The glucose values used as reference values are obtained using the YSI method. The YSI method is traceable to a primary NIST standard. Betachek C50 blood glucose monitoring system meets the requirements of EN ISO15197 (2013). Calibration and traceability Freshly obtained capillary blood is the only allowable sample.

  • Page 55: Index

    14 Index error messages after meal (flag) exp (symbol) 9,31,47 after meal test reminder 23-24 expiry 9,29,47 app (iphone/android application) apple (symbol) 23-24, 47 flagging results apple core (symbol) 24,48 after meal apply blood after meal test reminder asterisk (symbol) 23,47 before meal control test...
  • Page 56 system components maintenance memory technical data averages temperature results storage menu testing settings test cassette system tools checking the expiry meter disposal checking accuracy inserting a test cassette cleaning removing a test cassette parts summary storage set up validity 9,29,47 storage test cassette (symbol) tests remaining...

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