ASCENSIA CONTOUR NEXT ONE Manual
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ASCENSIA CONTOUR NEXT ONE Manual

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

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Summary of Contents for ASCENSIA CONTOUR NEXT ONE

  • Page 1 ONTOUR ® Works with free C IABETES app. www.diabetes.ascensia.com/warranty 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 ONE meters and C ONTOUR ONTOUR test strips are used TM see www.ascensiadiabetes.ca/tm-mc ® The Bluetooth...

  • Page 3: Table Of Contents

    Table of Contents 1 GETTING STARTED Your meter display Meter symbols The C ONTOUR IABETES 2 TESTING Fingertip testing 3 LOGBOOK 4 SETTINGS Change the Time and Date Put your meter in pairing mode 5 HELP Clean and disinfect your meter Replace meter batteries Test with control solution 6 TECHNICAL INFORMATION...
  • Page 4 INTENDED USE ONTOUR ® The C ONE 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 ONE blood glucose monitoring system is...
  • Page 5 INTENDED USE: C ONTOUR IABETES ONTOUR ® The C IABETES 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: Serious Illness Capillary blood glucose testing may not be clinically Talk to Your Health Care Professional: •...
  • Page 7 Potential Biohazard • • • 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 • • Contact Information •...
  • Page 9 not storing the strips in their original bottle can damage Do not use a test strip that appears damaged or has • NOTE: • • Contact Information • approximately 20 minutes for the meter to adjust to the temperature of the new location before performing a blood •...
  • Page 10 • • Your C ONTOUR ONE meter has been preset and Example: Contact Information • The C ONTOUR ONE blood glucose monitoring the meter displays the LO Contact your health care professional immediately. the meter displays the HI follow medical advice immediately...

  • Page 11: Getting Started

    GETTING STARTED Your C ONTOUR ONE meter and ONTOUR test strip Up Button Press to scroll up Press and hold to keep scrolling OK Button Press and hold to turn the meter On or Off Press to accept a selection Down Button Press to scroll down Press and hold...
  • Page 12 Your C ONTOUR ONE meter Screen Test Strip Test Result in Target Time Port smartLIGHT Date Meal Marker Your Meter Symbols Symbol What the Symbol Means above below Target Range Target Range Target Range Logbook Meter Settings Fasting Before Meal...
  • Page 13 Symbol What the Symbol Means After Meal Target Range or Target Target Light (smartLIGHT ® Bluetooth symbol: indicates the Bluetooth setting is On; the meter can communicate with a Your Meter Features ® sampling allows you to apply more blood to...

  • Page 14: The Contour Diabetes App

    The C ONTOUR IABETES for Your ONE meter Your C ONTOUR ONTOUR IABETES app and your compatible smartphone or You can do the following with your C ONTOUR IABETES app: • • • • • • Fasting Before Meal After Meal Overall •...
  • Page 15 Download the C ONTOUR IABETES or the Google Play ONTOUR IABETES ONTOUR IABETES CAUTION: The C ONTOUR ONE meter has not been tested for use with any software other than compatible responsible for any erroneous results from the use of other Initial Setup from the ONTOUR IABETES...
  • Page 16 Initial Setup from the Meter OK Button Press and hold OK The screen displays the Power On Self Test 8.8.8 displays fully and that the Contact Information 1 View Overall Target Range Overall Target Range The meter displays a pre- set Overall Target Range You can change this pre- set Target Range from the...
  • Page 17 2 Set the Time Outer Ring button on the outer AM or PM then press OK Continue to Set the Date...
  • Page 18 3 Set the Date 4 Setup Is Complete Setup is complete. You are ready to test your blood.

  • Page 19: Testing

    TESTING Get Ready to Test Read your C ONTOUR Contact Information CAUTION: Your C ONTOUR with C test strips and C ONTOUR ONTOUR control Fingertip Testing testing: • C ONTOUR • C ONTOUR • 5 Help: Control Solution Testing 6 Technical Information: Customer Service Checklist...
  • Page 20 WARNING: Potential Biohazard • 5 Help: Cleaning and Disinfection • • For complete instructions on cleaning and disinfecting 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 the most common symptoms are: Low blood glucose (Hypoglycemia): •...
  • Page 21 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 22 Prepare the Lancing Device Refer to your lancing device insert for detailed or palm testing. WARNING: Potential Biohazard • • WARNING: Potential Biohazard...
  • Page 23 Insert the Test Strip CAUTION: NOTE: ONTOUR test blood drop indicating it is ready NOTE:...
  • Page 24 Get the Blood Drop: Fingertip Testing WARNING against the puncture site and the test strip to the drop of The blood is drawn into the CAUTION: Do not press the tip of the test strip against the could lead to inaccurate 3.
  • Page 25 Second-Chance sampling—Apply More Blood About Meal Markers Meal Marker to your result when the Meal Marker feature in the meter is turned On What the Symbol Symbol Related Target Range Means Fasting Target Range Fasting water or non-caloric Before Meal Before Target Range Meal...
  • Page 26 What the Symbol Symbol Related Target Range Means After Meal After Target Range Meal Overall Target Range times other than after Mark fasting or before or after Your C ONTOUR ONE meter comes with Meal Markers turned Meal Markers On in Settings 4 Settings: Set Meal Marker Feature Add a Meal Marker to a Reading NOTE:...
  • Page 27 Meal Marker is Meal Marker button to scroll between Meal Marker you OK Button Meal Marker Meal Marker Logbook without a Meal Marker Blood Glucose Test Is Complete Target Meal Marker selected:...
  • Page 28 NOTE: To change a Meal Marker the C ONTOUR IABETES Target Light (smartLIGHT) setting is On to the Fasting Before Meal After Meal Overall Target Range Green means In Target Red means Below Target Yellow means Above Target Target Light (smartLIGHT Meal Marker result is compared to an Overall Target Range...
  • Page 29 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 • If your blood glucose reading is over the recommended limit set by your health care professional: Expected Test Result Values...
  • Page 30 LO or HI Results • displays the LO blood glucose reading is under Follow medical advice immediately. Contact • displays the HI follow medical advice immediately...
  • Page 31 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 32 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 33: Logbook

    LOGBOOK The Logbook contains blood glucose test results and their Meal Markers Logbook reaches the maximum Logbook Review the Logbook NOTE: To return to the Home Logbook Logbook: 1. Press and hold OK The Logbook Home Logbook press OK 4. To scroll through your test...

  • Page 34: Settings

    LO or HI 2 Testing: LO or HI Results OK to go to the Home Logbook SETTINGS Settings you can: • • • Turn Sound • Turn Meal Markers • Target Ranges • Turn Target Lights (smartLIGHT • Turn Bluetooth NOTE: Press OK to accept the current or changed setting before...
  • Page 35 Access Settings 1. Press and hold OK OK Button The Home screen has 2 options: Logbook Settings 2. To highlight the Settings symbol Settings OK to enter Settings To exit Settings TURN OVER TO SEE BACK...
  • Page 36 Change the Time Time Format screen: 1. From the Home the Settings symbol and press OK to enter Settings Time Format AM or PM press OK The meter displays the Date Format...
  • Page 37 Change the Date Date Format screen: 1. From the Home the Settings symbol and press OK to enter Settings 2. Continue to press OK until you see the Date Format Date Format The date format (m/d or d.m 3. To select Month/Day/Year (m/d) or Day.Month.Year (d.m press the press the press OK...
  • Page 38 Set the Sound Sound screen: 1. From the Home the Settings symbol and press OK to enter Settings 2. Continue to press OK until you see the Sound Your meter comes with the Sound turned On Sound Sound is On: •...
  • Page 39 Set Meal Marker Feature Meal Marker screen: 1. From the Home the Settings symbol and press OK to enter Settings 2. Continue to press OK until you see the Meal Marker Your meter comes with the Meal Marker feature turned OFF 3.
  • Page 40 View Target Ranges WARNING Discuss your Target Range settings with your health care professional. Meal Marker feature is On Fasting Before Meal After Meal Overall Target Range in Settings NOTE: You can only change the Target Ranges in the ONTOUR IABETES Fasting Target Range screen: 1.
  • Page 41 The meter displays the Overall Target Range 6. Press OK The meter displays the Target Lights Set Target Lights (smartLIGHT target range indicator) Your meter comes with the Target Light setting turned On displays a Target Light in a colour that corresponds to your test Green means In Target Red means Below Target...
  • Page 42 3. To turn Target Lights On or button to 4. Press OK The meter displays the Bluetooth Set Bluetooth Wireless Functionality Bluetooth Bluetooth setting is turned On Bluetooth screen: 1. From the Home the Settings symbol and press OK to enter Settings 2.
  • Page 43 Pairing Mode CAUTION: There is a remote possibility that a computer specialist could listen in on your wireless communications when you pair the blood glucose meter and would then be To pair your meter with the C ONTOUR IABETES the app and follow the instructions to Pair a Meter To put your meter in pairing mode: 2.

  • Page 44: Help

    HELP Meter Care Caring for your meter: • • • • • Clean and disinfect your meter as recommended in the next Your C ONTOUR Contact Information...

  • Page 45: Clean And Disinfect Your Meter

    Cleaning and Disinfection WARNING WARNING Clean and disinfect your C ONTOUR ONE meter once a ONTOUR Contact Information • Cleaning • Disinfecting...
  • Page 46 For more information Cleaning Your Meter Clean and disinfect your meter once a week. • • CAUTION: Do not allow cleaning solution to run into the 1. Carefully clean the meter with germicidal wipes until all soil is...
  • Page 47 Disinfecting Your Meter Clean and disinfect your meter once a week. • • • Cleaning Your Meter NOTE: Buttons Test Strip Port...
  • Page 48 Cleaning and Disinfecting Your Lancing Device Refer to the lancing device insert provided with your kit for detailed instructions for cleaning and disinfecting the lancing device. Transfer Results to the ONTOUR IABETES CAUTION: The C ONTOUR ONE meter has not been tested for use with any software other than compatible responsible for any erroneous results from the use of other You can automatically transfer results from your...
  • Page 49 Transfer Results to a Personal Computer CAUTION: Do not attempt to perform a blood glucose test when the C ONTOUR ONE 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 CAUTION: Batteries displaying the Low Batteries...
  • Page 50 Replace the Batteries NOTE: If you put the new batteries in the meter within 5 minutes of taking the old batteries out, the meter saves all your settings and results. Always check the date and time after you replace the batteries. If they are correct, other settings and results are also saved.
  • Page 51 7. Press the second battery into the other compartment the WARNING Keep batteries away from children. Many types of batteries are poisonous. If swallowed, immediately contact your poison control center. Control Solution WARNING Shake the control solution well before testing. ONTOUR CAUTION: with your C...
  • Page 52 WARNING • Do not calibrate your continuous glucose monitoring device from the control result. • Do not calculate a bolus based on a control result. CAUTION: Do not use expired material can cause ONTOUR ONE meter with control solution when the Contact Information...
  • Page 53 Control Solution Testing NOTE: ONTOUR the test strip into the test strip CAUTION: Do not use control solution that is more than solution, write the date on the bottle.
  • Page 54 CAUTION: 7. Hold the tip in the drop until the meter beeps. The meter counts down for 5 seconds before the meter included in your meter Logbook or in targets in the C ONTOUR IABETES 8. Compare your control test result with the range printed on the ONTOUR ONE meter for blood glucose testing until you Contact...

  • Page 55: 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 test with a C ONTOUR Moisture Damaged Repeat the test with a new...
  • Page 56 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 57 Customer Service Checklist ONTOUR ONTOUR ONTOUR control A) and serial number (B Parts Information Contact Information • • C ONTOUR • C ONTOUR • C ONTOUR • C ONTOUR • C ONTOUR • C ONTOUR • •...
  • Page 58 Technical Information: Accuracy The C ONTOUR ONE blood glucose monitoring system 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 ONTOUR...
  • Page 59 Table 3: System accuracy results for glucose concentrations between 2.0 mmol/L and 35.7 mmol/L Within ± 0.83 mmol/L or ± 15% User Accuracy results: of the medical laboratory glucose concentrations Technical Information: Precision ONTOUR ONE blood glucose monitoring system using ONTOUR...
  • Page 60 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 ONE meter using C ONTOUR ONTOUR...
  • Page 61 Industry Canada Statement This equipment complies with radiation exposure limits set forth Test Sample: Test Result: Sample Volume: Measuring Range: blood Countdown Time: 5 seconds Memory: Battery Type: Battery Life: Meter Operating Temperature Range: Control Testing Temperature Range: Meter Operating Humidity Range: Dimensions: Weight: Meter Life: 5 years...
  • Page 62 Sound Output: Radio Frequency Technology: Bluetooth Radio Frequency Band: Maximum Radio Transmitter Power: Modulation: Electromagnetic Compatibility (EMC): The ONTOUR ONE meter complies with the electromagnetic ONTOUR The C ONTOUR ONTOUR ONE meter the C ONTOUR ONE meter near electrical or electronic...
  • Page 63 Product Labeling Symbols The following symbols are used throughout the product labeling for the C ONTOUR ONE blood glucose monitoring system Symbol What It Means Do not reuse Discard Control Discard Date Date: Temperature limitations Consult instructions for use Control Range Normal Control Range High...
  • Page 64 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 disposal Principles of the Procedure: The C ONTOUR ONE blood glucose test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on...
  • Page 65 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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