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Ascensia Diabetes Care Contour next GEN User Manual

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ONTOUR ®
Works with free C
D
IABETES
app.
www.diabetes.ascensia.com/warranty
10 45
4 12
52
ONTOUR ®
Uses only C
N
EXT
blood glucose test strips.
USER GUIDE

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Summary of Contents for Ascensia Diabetes Care Contour next GEN

  • Page 1 ONTOUR ® Works with free C IABETES app. www.diabetes.ascensia.com/warranty 10 45 4 12 ONTOUR ® Uses only C blood glucose test strips. USER GUIDE...
  • Page 2 CONTACT INFORMATION Manufactured for: www.diabetes.ascensia.com Purchase of this product does not alone confer a license to use under GEN meters and C ONTOUR ONTOUR test strips are used TM see www.ascensiadiabetes.ca/tm-mc ® The Bluetooth word mark and logos are registered trademarks...

  • Page 3: Table Of Contents

    Table of Contents 1 GETTING STARTED Your meter display Meter symbols and the Home screen 2 TESTING Fingertip testing Understand test results 3 LOGBOOK 4 SETTINGS Change the Time and Date Change Target Ranges Download the C ONTOUR IABETES Put your meter in pairing mode 5 HELP Clean and disinfect your meter Replace meter batteries...
  • Page 4 INTENDED USE The C ONTOUR GEN blood glucose monitoring system is intended to be used for the measurement of blood glucose in both insulin and non-insulin treated patients with diabetes as an aid for patients and their health care professionals in The C ONTOUR GEN blood glucose monitoring system is...
  • Page 5 INTENDED USE: C ONTOUR IABETES ONTOUR ® The C IABETES meter readings, either manually entered in the app or wirelessly transmitted from the C ONTOUR Other related health indicators which can be captured and shown in a printable report and graphical format on a mobile and is designed to be used with a wirelessly enabled C ONTOUR...
  • Page 6 IMPORTANT SAFETY INFORMATION WARNING If your blood glucose reading is under the critical level you have established with your health care professional If your blood glucose reading is over the recommended limit set by your health care professional: If you get a similar result, follow your health care Serious Illness Capillary blood glucose testing may not be clinically Talk to Your Health Care Professional:...
  • Page 7 Potential Biohazard • water and dry them well before and after testing or • For complete instructions on cleaning and disinfecting 5 Help: Cleaning and Disinfection • not be used for assisted blood draws by health care • • should be handled as if capable of transmitting infectious •...
  • Page 8 Limitations • Altitude: This system has not been tested at altitudes higher • Hematocrit: C ONTOUR test strip results are not • Xylose: Do not use during or soon after xylose absorption PRECAUTIONS Read your C ONTOUR • GEN user guide, the •...
  • Page 9 or not storing the strips in their original bottle can damage Do not use a test strip that appears damaged or has • NOTE: • • If your control solution test result is out of range, contact Contact Information • or test strip is outside this range, you should not test until temperature of the new location before performing a blood •...
  • Page 10 • • Your C ONTOUR GEN meter has been preset and Example: Check your display screen to be sure the results are Contact Information • The C ONTOUR GEN blood glucose monitoring the LO screen, contact your health care professional immediately the HI screen, wash your hands or the test site and displays the HI screen, follow medical advice immediately...

  • Page 11: Getting Started

    GETTING STARTED Your C ONTOUR GEN meter and ONTOUR test strip Time Date 10 45 4 12 Meal Marker Press to scroll up Press and hold Press and hold OK to turn the to keep scrolling meter On or Off Press to scroll down Press OK to accept Press and hold...
  • Page 12 Check the Meter Display Press and hold OK The screen displays the Power On Self Test 88 88 88 88 88 meter screen fully displays 8.8.8 and that the white light from the test strip port If there are missing characters or if the strip port light is a colour other than Contact Information NOTE: Your meter comes with a pre-set time, date, and target...
  • Page 13 Symbol What the Symbol Means Your Logbook Meter Settings Fasting Before Meal After Meal Target Range or Target Range smartLIGHT same ® Bluetooth symbol: means the Bluetooth wireless setting is On; the meter can communicate with a Total number of blood glucose readings used to...
  • Page 14 The Home Screen The Home Logbook and Settings • To highlight the Logbook 10 45 4 12 Settings , press the • To enter the Logbook, press OK while the Logbook • To enter Settings, press OK while the Settings Your Meter Features ®...

  • Page 15: Testing

    TESTING Get Ready to Test Read your C ONTOUR GEN user guide, the lancing If the test strip bottle is open inside a new box of strips, do not Contact Information CAUTION: Your C ONTOUR GEN meter works only with C test strips and C ONTOUR ONTOUR...
  • Page 16 WARNING: Potential Biohazard • Help: Cleaning and Disinfection • and dry them well before and after testing or handling the • For complete instructions on cleaning and disinfecting your 5 Help: Cleaning and Disinfection High / Low Blood Glucose Symptoms of High or Low Blood Glucose You can better understand your test results by being aware of most common symptoms are: Low blood glucose (Hypoglycemia):...
  • Page 17 High blood glucose (Hyperglycemia): • frequent urination • increased fatigue • • hunger • Ketones (Ketoacidosis): • shortness of breath • • WARNING If you are experiencing any of these symptoms, test your blood glucose. If your test result is under the critical level you have established with your health care professional or over the recommended limit, follow your health care professional’s advice immediately.
  • Page 18 Prepare the Lancing Device Refer to your lancing device insert for detailed instructions WARNING: Potential Biohazard • • • Insert the Test Strip CAUTION:...
  • Page 19 NOTE: Tightly close the bottle lid immediately after ONTOUR test 2. Insert the grey square end The screen displays the blinking blood 10 45 4 12 drop indicating it is ready to test a blood NOTE:...
  • Page 20 Get the Blood Drop: Fingertip Testing NOTE: Testing: Alternative Site Testing (AST): Palm WARNING: Potential Biohazard and dry them well before and after testing or handling the against the puncture site and 2. Immediately touch the tip of the test strip to the drop of The blood is drawn into the 3.
  • Page 21 CAUTION: Do not press the tip of the test strip against the skin or place the blood on top lead to inaccurate results or Second-Chance sampling—Apply More Blood 1. If the meter beeps twice and the screen 00 60 displays a blinking blood drop with a plus same test strip NOTE: If the screen displays an E 1 error...
  • Page 22 About Meal Markers You can attach a Meal Marker to your blood glucose result when the Meal Marker Your C ONTOUR GEN meter comes with Meal Markers Meal Markers On and change Target Ranges in Settings 4 Settings Symbol What It Means Target Range Use when testing The meter compares your...
  • Page 23 Add a Meal Marker to a Reading During a blood glucose test, if Meal Markers are On, you can select a Meal Marker You cannot select a Meal Marker in the Settings screen. 2 Testing: About Meal Markers Example: Do not press OK or remove 5 65 the test strip yet.
  • Page 24 Meal Marker you want is blinking, press OK 4. If this is a Before Meal reading, you can set a Reminder to 2 Testing: Set a Test Reminder If you do not make a Meal Marker Logbook without a Meal Marker Set a Test Reminder 1.
  • Page 25 smartLIGHT target range indicator your result with the units, time, date, meal marker (if selected), , In Target , or Meal Marker selected and a Reminder set: 10 45 4 12 NOTE: To change a Meal Marker you selected, you must use the C ONTOUR IABETES...
  • Page 26 Home screen, press OK Test Results WARNING • Always consult your health care professional before changing your medication based on test results. • If your blood glucose reading is under the critical level you have established with your health care professional •...
  • Page 27 Expected Test Result Values plasma glucose concentrations are normally maintained within You should consult with your health care LO or HI Results • If the meter beeps twice and displays 10 45 4 12 the LO screen, your blood glucose Follow medical advice immediately.
  • Page 28 Eject and Dispose of the Used Lancet 2. Refer to the separate lancing device insert, if provided with your kit, for instructions on automatic ejection of the lancet. WARNING: Potential Biohazard • The lancing device, lancets, and test strips are for single-patient use.
  • Page 29 Alternative Site Testing (AST): Palm WARNING • Ask your health care professional if Alternative Site Testing (AST) is right for you. • Do not calibrate a continuous glucose monitoring device from an AST result. • Do not calculate an insulin dose based on an AST result.

  • Page 30: Logbook

    LOGBOOK The Logbook contains blood glucose test results and their Meal Logbook reaches the maximum 800 results, Logbook Review the Logbook NOTE: To return to the Home Logbook, press OK Logbook: 1. Press and hold OK The Logbook 2. To select the blinking Logbook 10 45 4 12 symbol, press OK...
  • Page 31 If you scroll past the oldest entry, the meter displays the End If you see a LO or HI 2 Testing: LO or HI Results OK to go to the Home screen, then select the Logbook View Averages 1. To enter the Logbook from the Home screen, press OK while the Logbook button from the Logbook...

  • Page 32: Settings

    SETTINGS In Settings you can personalize: • Time • Reminder • Date • Target Ranges. • Sound. • smartLIGHT • Meal Markers. • Bluetooth wireless NOTE: Press OK to accept the current or changed setting before Access Settings 1. Press and hold OK until the The Home Logbook and Settings...
  • Page 33 4. To scroll through Settings options as 10 45 4 12 shown in the image, press the button until the symbol you want is 5. Press OK 6. To exit from the Settings menu and 10 45 4 12 return to the Home screen, press the button until the Settings 7.
  • Page 34 3. To change the time format, if needed, press the button, then press OK 4. To change the hour (blinking), press 10 45 button, then press OK 5. To change minutes (blinking), press 10 45 button, then press OK AM or PM, as needed, then press OK Change the Date 1.
  • Page 35 3. To select Month/Day/Year (m/d) or Day.Month.Year (d.m), press the button, then press OK 4. To change the year (blinking), press 4 12 00 button, then press OK 5. To change the month (blinking), press 4 12 00 button, then press OK 6.
  • Page 36 Set the Sound 1. From the Home screen, select the Settings symbol and press OK to enter Settings Settings screen, press the button repeatedly until the Sound symbol is blinking, then press OK 3. To turn the Sound 4. Press OK Your meter comes with the Sound Sound Sound is On:...
  • Page 37 Set Meal Marker Feature 1. From the Home screen, select the Settings symbol and press OK to enter Settings Settings screen, press the button repeatedly until the Meal Marker symbols are blinking, then press OK Your meter comes with the Meal Marker 3.
  • Page 38 Set Reminder Feature Meal Markers are On, you can set a Reminder to test your blood glucose after you mark a reading as Before Meal Meal Markers 4 Settings: Set Meal Marker Feature 1. From the Home screen, select the Settings symbol and press OK to enter Settings Settings screen, press the...
  • Page 39 Change Overall Target Range WARNING Discuss your Target Range settings with your health care professional. Overall Target Range change the Overall Target Range in Settings 1. From the Home screen, select the Settings symbol and press OK to enter Settings Settings screen, press the button repeatedly until the Target...
  • Page 40 Change Before/After Meal Target Ranges Meal Marker Ranges on your meter: a Before Meal Target Range (the same as Fasting) and an After Meal Target Range You can change these ranges in Settings in your meter and in the C ONTOUR IABETES 1.
  • Page 41 NOTE: The Before Meal Target Range is also the Target Range for a blood glucose reading marked as Fasting After Meal High Target 7. To change the blinking High end 39 -1 00 of the After Meal Target Range, press the 8.
  • Page 42 3. To turn the smartLIGHT 4. Press OK Set Bluetooth Wireless Functionality Bluetooth 4 Settings: Pairing Mode 1. From the Home screen, select the Settings symbol and press OK to enter Settings Settings screen, press the button repeatedly until the Bluetooth symbol is blinking, then press OK Bluetooth...
  • Page 43 ONTOUR IABETES The C ONTOUR IABETES app for Your ONTOUR GEN meter Your C ONTOUR GEN meter is designed to work with the ONTOUR IABETES app and your compatible smartphone or You can do the following with your C ONTOUR IABETES app: •...

  • Page 44: Ontour Diabetes

    Download the C ONTOUR IABETES 1. On your compatible smartphone or tablet, go to the or the Google Play ONTOUR IABETES 3. Install the C ONTOUR IABETES CAUTION: The C ONTOUR GEN meter has not been tested for use with any software other than the ONTOUR IABETES Pairing Mode...
  • Page 45 Meter serial number 34 56 7 Pass code CO de 89 12 34 4. Enter the pass code on the smart your meter with the C ONTOUR IABETES app, the meter displays a blue light and the Bluetooth The meter returns to the Home Bluetooth NOTE: You can update your Target Ranges from the meter or...

  • Page 46: Help

    HELP Meter Care Caring for your meter: • • • • • Clean and disinfect your meter as recommended in the next cause any damage or degradation to the external case, buttons, Your C ONTOUR 5 years of cleaning and disinfection without damage, by a Contact Information...

  • Page 47: Clean And Disinfect Your Meter

    Cleaning and Disinfection WARNING • and dry them well before and after testing or handling the • If your meter is being operated by a second person who is Clean and disinfect your C ONTOUR GEN meter once a ® ONTOUR Contact Information •...
  • Page 48 For more information Cleaning Your Meter Clean and disinfect your meter once a week. • Clorox Healthcare • CAUTION: Do not allow cleaning solution to run into the meter through open areas, such as around the buttons or the 1. Carefully clean the meter with germicidal wipes until all soil...
  • Page 49 Disinfecting Your Meter Clean and disinfect your meter once a week. • Clorox Healthcare • • Cleaning Your Meter 2. Using a new germicidal wipe, carefully wipe all outer surfaces NOTE: For proper disinfection, you must keep all meter surfaces Buttons Test Strip Port 3.
  • Page 50 Transfer Results to a Personal Computer CAUTION: Do not attempt to perform a blood glucose test when the C ONTOUR GEN meter is connected to a You can transfer test results from the C ONTOUR meter to a computer where they can be summarized in a report door is completely closed when USB Port CAUTION:...
  • Page 51 Batteries 10 45 4 12 operates normally, displaying the Low Batteries symbol until you replace the a test, the meter displays the Dead Batteries Replace the Batteries...
  • Page 52 NOTE: Always check the date and time after you replace the batteries. 5. Press each battery into a WARNING Keep batteries away from children. Many types of batteries are poisonous. If swallowed, immediately contact your poison control center.
  • Page 53 Control Solution WARNING Shake the control solution well before testing. CAUTION: Use only C ONTOUR with your C ONTOUR GEN blood Using anything other than ONTOUR control solution can You should perform a control test when: • • • • WARNING •...
  • Page 54 CAUTION: Do not use expired material can cause inaccurate expiration dates on your test Refer to your control solution insert. ONTOUR GEN meter with control solution only when the Contact Information...
  • Page 55 Control Solution Testing NOTE: ONTOUR 2. Insert the grey square end of the test strip into the test strip The meter turns on, displaying a test strip with a CAUTION: Do not use control solution that is more than solution, write the date on the bottle. Unmixed control solution may cause...
  • Page 56 CAUTION: 6. Immediately touch the tip of the test strip to the drop of control 7. Hold the tip in the drop until the meter beeps. The meter counts down for 5 seconds before the meter in your meter Logbook targets in the C ONTOUR IABETES...

  • Page 57: Technical Information

    TECHNICAL INFORMATION Error Detection Displays The meter screen displays error codes (E plus a number) for Press OK Contact Information Error What It Means What to Do Code Strip Errors Repeat the test with a ONTOUR Moisture Damaged Repeat the test with a new...
  • Page 58 Error What It Means What to Do Code Testing Errors Repeat the test with a new Testing Error Too Cold to Test control solution to a warmer Too Hot to Test control solution to a cooler Too Cold to Test Too Hot to Test System Errors Meter software...
  • Page 59 Customer Service Checklist ONTOUR blood glucose meter, ONTOUR test strips, and ONTOUR control solution and serial number (B) on the Parts Information To replace missing parts or reorder supplies, contact Customer Contact Information • • C ONTOUR • C ONTOUR •...
  • Page 60 Technical Information: Accuracy The C ONTOUR GEN blood glucose monitoring system was ONTOUR test Table 1: System accuracy results for glucose concentration < 5.55 mmol/L Within Within Within between YSI laboratory ± 0.28 ± 0.56 ± 0.83 reference method and mmol/L mmol/L mmol/L...
  • Page 61 Table 3: System accuracy results for glucose concentrations from 1.9 mmol/L to 29.1 mmol/L Within ± 0.83 mmol/L or ± 15% User Accuracy results: Technical Information: Precision ONTOUR GEN blood glucose monitoring system using ONTOUR test strips was tested 10 times on...
  • Page 62 Table 1: System repeatability results for C ONTOUR meter using C ONTOUR test strips Pooled Mean, Standard 95% CI of mmol/L Deviation, SD, mmol/L Variation, % mmol/L of C ONTOUR test strips was tested once on each of Table 2: System intermediate precision results for GEN meter using C ONTOUR ONTOUR...
  • Page 63 Industry Canada Statement must accept any interference, including interference that may This equipment complies with radiation exposure limits set forth Test Sample: Test Result: Sample Volume: Measuring Range: glucose in blood Countdown Time: 5 seconds Memory: Battery Type: Battery Life: Meter Storage Temperature Range: Meter Operating Temperature Range: Control Testing Temperature Range:...
  • Page 64 Test Strip Storage Conditions: Dimensions: Weight: Meter Life: 5 years with normal use in accordance with instructions Sound Output: Radio Frequency Technology: Bluetooth Radio Frequency Band: Maximum Radio Transmitter Power: Modulation: Electromagnetic Compatibility (EMC): The ONTOUR GEN meter complies with the electromagnetic emissions are low and unlikely to interfere with other nearby electronic equipment, nor are emissions from nearby electronic equipment likely to interfere with the...
  • Page 65 Product Labeling Symbols The following symbols are used throughout the product labeling for the C ONTOUR GEN blood glucose monitoring system (meter packaging and labeling, and test strip and control Symbol What It Means Use by date (last day of the month) Do not reuse Catalogue number Discard...
  • Page 66 Symbol What It Means The meter should be treated as contaminated should not be disposed of with waste electronic Contact your health care professional or local waste disposal authority for medical waste Principles of the Procedure: The C ONTOUR GEN blood glucose test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the Comparison Options: The C...
  • Page 67 References Practical Diabetes. Annals of Internal Medicine. Mayo Clinic Proceedings Harrison’s Principles of Internal Medicine Tietz Fundamentals of Clinical Chemistry...

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