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Contour NEXT ONE User Manual

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Blood Glucose Monitoring System
Works with free C
Warranty information and online meter registration
available at www.diabetes.ascensia.com/warranty
or call our Customer Service.
ONTOUR ®
D
IABETES
Uses only C
blood glucose test strips.
USER GUIDE
app.
ONTOUR ®
N
EXT

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Satish Gupta
May 5, 2025

my glucometer battery needs replacement. Nmae Contour Next Model 7902E Ref 90008866

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Summary of Contents for Contour NEXT ONE

  • Page 1 Blood Glucose Monitoring System ONTOUR ® Works with free C IABETES app. Warranty information and online meter registration available at www.diabetes.ascensia.com/warranty or call our Customer Service. ONTOUR ® Uses only C blood glucose test strips. USER GUIDE...

  • Page 2: Table Of Contents

    Table of Contents 1 GETTING STARTED Your meter display Meter symbols The C ONTOUR IABETES Initial setup 2 TESTING Fingertip testing Add a Meal Marker to a blood glucose result Understand test results 3 LOGBOOK View test results 4 SETTINGS Change the Time and Date View Target Ranges Put your meter in pairing mode...
  • Page 3 INTENDED USE ONTOUR ® The C ONE blood glucose monitoring system is intended to be used for the quantitative measurement of or palm. The C ONTOUR ONE blood glucose monitoring system is intended to be used by a single person and should not be shared.
  • Page 4 IMPORTANT SAFETY INFORMATION WARNING If your blood glucose reading is under the critical level you have established with your health care professional, follow their advice immediately. If your blood glucose reading is over the recommended limit set by your health care professional: 1.
  • Page 5 Potential Biohazard • Always wash your hands with soap and water and dry them well before and after testing or handling the meter, lancing device, or test strips. • If your meter is being operated by a second person who is providing testing assistance to you, the meter and lancing device should be disinfected prior to use by the second person.
  • Page 6 • The meter and lancing device are for single-patient use. Do not share them with anyone including other family members! Do not use on multiple patients. • The lancing device usually provided with your kit should not be used for assisted blood draws by health care professionals or at health care provision sites.
  • Page 7 Limitations • Serious Illness: The system should not be used to test critically ill patients and should not be used by persons with in severely hypotensive individuals or patients in shock. Inaccurate low results may occur for individuals experiencing a hypoxia state, or a hyperglycemic-hyperosmolar state, with or without ketosis.
  • Page 8 PRECAUTIONS Read your C ONTOUR • ONE user guide, the lancing device package insert, if provided, and all instructional materials provided in your meter kit before testing. Follow all instructions for use and care exactly as described to help avoid inaccurate results. •...
  • Page 9 • Do not use expired materials. Using expired material can cause inaccurate results. Always check the expiration dates on your test materials. NOTE: solution, write the date on the bottle. • Do not use control solution that is more than 6 months past •...
  • Page 10 • Your C ONTOUR ONE meter has been preset and per deciliter of blood). Example: Check your display screen to be sure the results are shown correctly. If not, contact Customer Service. See Contact Information. • The C ONTOUR ONE blood glucose monitoring system If your meter does not display a value and displays the LO screen, contact your health care professional 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 Target Range. in Target Range. below Target Range. Blood glucose test result is in Target Range. Blood glucose test result is above Target Range.
  • Page 13 Symbol What the Symbol Means No marker selected. A Target Range or Target setting. Target Light (smartLIGHT ) setting. Meter is ready to test. Add more blood to strip. Control solution result. ® Bluetooth symbol: indicates the Bluetooth setting is On; the meter can communicate with a mobile device.

  • Page 14: The Contour Diabetes App

    The C ONTOUR IABETES for Your ONE meter Your C ONTOUR ONE meter was designed to work with ONTOUR ® the C IABETES app and your compatible smartphone or tablet. You can do the following with your C ONTOUR IABETES app: •...

  • Page 15: Initial Setup

    CAUTION: The C ONTOUR ONE meter has not been tested for use with any software other than compatible Ascensia Diabetes Care software. The manufacturer is not responsible for any erroneous results from the use of other software. Initial Setup from the ONTOUR IABETES The easiest way to set up your new meter is to download the...
  • Page 16 It is very important to verify that 8.8.8 displays fully and that the white light from the test strip port is visible. If there are missing characters or if the strip port light is a color way you see your results. See Contact Information. Initial setup begins with a view of the Overall Target Range.
  • Page 17 2. To set the hour and move to minutes, press OK. 3. To change the minutes, press button on the outer ring, then press OK. For a 12-hour format, select AM or PM, press the button, then press OK. Continue to Set the Date. 3 Set the Date The year is blinking.

  • Page 18: Testing

    TESTING Get Ready to Test Read your C ONTOUR ONE user guide, the lancing device package insert, if provided, and all instructional materials provided in your meter kit before testing. Examine the product for missing, damaged, or broken parts. If the test strip packaging is open or damaged, do not use those test strips.
  • Page 19 WARNING: Potential Biohazard • All parts of the kit are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection. See Section 5 HELP: Cleaning and Disinfection. • Always wash your hands with soap and water and dry them well before and after testing or handling the meter, lancing device, or test strips.
  • Page 20 High blood glucose (Hyperglycemia): • frequent urination • increased fatigue • excessive thirst • hunger • blurred vision Ketones (Ketoacidosis): • shortness of breath • very dry mouth • nausea or vomiting WARNING If you are experiencing any of these symptoms, test your blood glucose.
  • Page 21 Prepare the Lancing Device Refer to your lancing device insert for detailed instructions testing. WARNING: Potential Biohazard • The lancing device usually provided with your kit is intended for single-patient use only. It should not be used for assisted blood draws by health care providers or at health care provision sites, and should never be shared with anyone else, even a family member, due to risk of infection.
  • Page 22 NOTE: If strips are stored in a bottle, tightly close the bottle lid immediately after you remove the test strip. Some supplies are not available in every region. 1. Remove a C ONTOUR test strip. 2. Insert the grey square end until the meter beeps.
  • Page 23 Get the Blood Drop: Fingertip Testing WARNING • Always wash your hands with soap and water and dry them well before and after testing or handling the meter, lancing device, or test strips. • If your meter is being operated by a second person who is providing testing assistance to you, the meter and lancing device should be disinfected prior to use by the second person.
  • Page 24 Second-Chance sampling—Apply More Blood 1. If the meter beeps twice and the screen displays a blinking blood drop, the test strip does not have enough blood. 2. Apply more blood to the same test strip within 60 seconds. 3. If the screen displays an E 1 error message, remove the strip and start with a new strip.
  • Page 25 What the Symbol Symbol Related Target Range Means Use when testing After Meal Target After blood glucose levels Range Meal within 2 hours after Use when testing at Overall Target Range No Mark times other than after fasting or before or after a meal.
  • Page 26 1. If the blinking Meal Marker is the one you want, press OK Meal Marker, press the button to scroll between markers. 3. When the Meal Marker you want is blinking, press OK. OK Button If you do not select a Meal Marker within 30 seconds, the screen dims.
  • Page 27 NOTE: To change a Meal Marker you selected, you must use the C ONTOUR IABETES app. If the Target Light (smartLIGHT) setting is On, the test strip port displays a color representing your result value compared to the Fasting, Before Meal, After Meal, or Overall Target Range.
  • Page 28 Test Results WARNING • Always consult your health care professional before changing your medication based on test results or if your test results are not consistent with the way you feel. • If your blood glucose reading is under the critical level you have established with your health care professional, follow medical advice immediately.
  • Page 29 LO or HI Results • If your meter does not display a value and displays the LO screen, your blood glucose Contact your health care professional immediately. • If your meter does not display a value and displays the HI screen, your blood glucose Wash your hands or the test site and repeat the test...
  • Page 30 Alternative Site Testing (AST): Palm See the lancing device insert for detailed instructions on Alternative Site Testing. 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.
  • Page 31 Eject and Dispose of the Used Lancet remove the lancet from the lancing device. 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 32: Logbook

    LOGBOOK The Logbook contains blood glucose test results and their Meal Markers. When the Logbook reaches the maximum 800 results, the oldest test result is removed as a new test is completed and saved to the Logbook. Review the Logbook NOTE: To return to the Home screen while viewing the Logbook, press OK.

  • Page 33: Settings

    If you scroll past the oldest entry, the meter displays the End screen. If you see a LO or HI test result, go to Section 2 TESTING: LO or HI Results for more information. 5. To go back to the beginning to review entries, press OK to go to the Home screen, then select the Logbook symbol.
  • Page 34 Access Settings 1. Press and hold OK until the meter turns on. OK Button The Home screen has 2 options: Logbook and Settings 2. To highlight the Settings symbol press the button. 3. When the Settings symbol is blinking, press OK to enter Settings.
  • Page 35 Change the Time If you are not on the Time Format screen: 1. From the Home screen, select the Settings symbol and press OK to enter Settings. The time format (12 hour or 24 hour) is blinking. 2. To change the time format, if needed, press the button, then press OK.
  • Page 36 Change the Date If you are not on the Date Format screen: 1. From the Home screen, select the Settings symbol and press OK to enter Settings. 2. Continue to press OK until you see the Date Format screen. Date Format The date format (m/d or d.m) is blinking.
  • Page 37 Set the Sound If you are not on the Sound screen: 1. From the Home screen, select the Settings symbol and press OK to enter Settings. 2. Continue to press OK until you see the Sound screen. Sound Symbol: Your meter comes with the Sound turned On. Certain error messages override any Sound setting.
  • Page 38 Set Meal Marker Feature If you are not on the Meal Marker screen: 1. From the Home screen, select the Settings symbol and press OK to enter Settings. 2. Continue to press OK until you see the Meal Marker screen. Meal Marker Symbols: Your meter comes with the Meal Marker feature turned OFF.
  • Page 39 If you are not on the Fasting Target Range screen: 1. From the Home screen, select the Settings symbol and press OK to enter Settings. 2. Continue to press OK until you see the Fasting Target Range screen below. 3. Press OK. The meter displays the Before Meal Target Range.
  • Page 40 Set Target Lights (smartLIGHT target range indicator) Your meter comes with the Target Light setting turned On. When this feature is On, the test strip port on your meter displays a Target Light in a color that corresponds to your test result. Green means In Target Red means...
  • Page 41 Set Bluetooth Wireless Functionality Bluetooth is not available until you pair your meter with a mobile device. After pairing, the Bluetooth setting is turned On. If you are not on the Bluetooth screen: 1. From the Home screen, select the Settings symbol and press OK to enter Settings.
  • Page 42 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 able to read your blood glucose readings from your meter. If you believe this is a risk, pair your blood glucose meter far away from other people.

  • Page 43: Help

    HELP Meter Care Caring for your meter: • Store the meter in the carrying case provided, whenever possible. • Wash and dry hands well before handling to keep the meter and test strips free of water, oils, and other contaminants. •...

  • Page 44: Clean And Disinfect Your Meter

    Cleaning and Disinfection WARNING Always wash your hands with soap and water and dry them well before and after testing or handling the meter, lancing device, or test strips. WARNING: Potential Biohazard All parts of the kit are considered biohazardous and can potentially transmit infectious diseases, even after you have performed cleaning and disinfection.
  • Page 45 Evaluate your device after performing cleaning and disinfection to ensure that the procedure does not cloud the face/display of the meter and does not corrode or erode the plastic housing or buttons. For more information on more than one person poses risk for transmitting bloodborne pathogens: initial communication.
  • Page 46 Disinfecting Your Meter Clean and disinfect your meter once a week. Supplies needed for disinfecting: • Clorox Germicidal Wipes containing 0.55% sodium hypochlorite (bleach). • Paper towels. • Timing device. 1. Before disinfecting, clean the meter as described in Cleaning Your Meter.
  • Page 47 Transfer Results to the ONTOUR IABETES CAUTION: The C ONTOUR ONE meter has not been tested for use with any software other than compatible Ascensia Diabetes Care software. The manufacturer is not responsible for any erroneous results from the use of other software.
  • Page 48 Batteries When the batteries are low, the meter operates normally, displaying the Low Batteries symbol until you replace the batteries. When you are no longer able to perform a test, the meter displays the Dead Batteries screen. Replace the batteries immediately.
  • Page 49 4. Make sure the ‘+’ sign is facing down on the new batteries. 5. Hold the battery holder so that the round end is on the right. 6. Insert the edge of one battery into the prongs on the left side of one compartment and press down on the right side of the battery.
  • Page 50 You should perform a control test when: • • You open a new bottle or package of test strips. • You think your meter may not be working properly. • You have repeated, unexpected blood glucose results. WARNING • Do not calibrate your continuous glucose monitoring device from the control result.
  • Page 51 Control Solution Testing NOTE: Tightly close the bottle lid immediately after you remove the test strip. 1. Remove a C ONTOUR test strip from the bottle or foil packet. 2. Insert the grey square end of the test strip into the test strip port until the meter beeps.
  • Page 52 4. Remove the bottle cap and use a tissue to wipe away any solution around the bottle tip before dispensing a drop. 5. Squeeze a small drop of solution onto a clean, nonabsorbent surface. CAUTION: the test strip directly from the bottle. 6.

  • Page 53: Technical Information

    TECHNICAL INFORMATION Error Detection Displays The meter screen displays error codes (E plus a number) for test result errors, strip errors, or system errors. When an error occurs, the meter beeps 2 times and displays an error code. Press OK If you experience continued errors, contact Customer Service.
  • Page 54 Error What It Means What to Do Code Testing Errors Repeat the test with a new Testing Error strip. If the error persists, contact Customer Service. Move the meter, strip, and Too Cold to Test control solution to a warmer Control Solution area.
  • Page 55 model number (A) and serial number (B) on the back of the meter. on the bottle or foil packet. 4. Check the battery status. Meter Kit Contents The table below lists all parts included in this meter kit. Required parts that may not be included in your kit are indicated by an (A) on the back of the meter (see above).
  • Page 56 Technical Information: User Accuracy The C ONTOUR ONE blood glucose monitoring system was tested by 372 lay users using capillary blood samples and three C ONTOUR test strip lots. The results were compared to the YSI Glucose Analyzer laboratory reference method, traceable to the CDC hexokinase method.
  • Page 57 Table 2: System accuracy results for glucose concentration in values between YSI laboratory Within Within Within Within reference ± 5% ± 10% ± 15% ± 20% method and ONTOUR meter Number (and 288 of 342 of 354 of 355 of percent) of samples (81.1%) (96.3%)
  • Page 58 Table 1: System repeatability results for C ONTOUR meter using C ONTOUR test strips Pooled Standard 95% CI of Mean, mg/dL Deviation, SD, mg/dL mg/dL 43.7 0.83–0.98 77.6 1.14–1.35 129.3 1.62–1.92 205.3 2.65–3.13 331.7 3.63–4.29 Intermediate measurement precision (which includes variability across multiple days) was evaluated using control solutions at 3 glucose levels.
  • Page 59 Federal Communications Commission This equipment has been tested and found to meet the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio...
  • Page 60 Compliance with these guidelines means that under normal, of other devices. In addition, the device should operate normally in the presence of other devices. In the event there is interference from another device, it is recommended that you increase the distance between the Bluetooth wireless technology on the meter.
  • Page 61 Dimensions: Weight: 36 grams Meter Life: 5 years Sound Output: 45 dB(A)–85 dB(A) at a distance of 10 cm Radio Frequency Technology: Bluetooth Radio Frequency Band: 2.4 GHz–2.483 GHz Maximum Radio Transmitter Power: 1 mW Modulation: Gaussian Frequency Shift Keying (GFSK) Electromagnetic Compatibility (EMC): The C ONTOUR ONE meter complies with the electromagnetic requirements...
  • Page 62 The following symbols from the International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC) are used throughout the product labeling for the C ONTOUR ONE blood glucose monitoring system (meter packaging and labeling, and test strip and control solution packaging and labeling). Symbol Standard Explanatory Text...
  • Page 63 Symbol Standard Explanatory Text Graphic/Title Reference Indicates the need for ISO 15223-1, the user to consult the Clause 5.4.3 Consult instructions for use. instructions for use Indicates the temperature ISO 15223-1, limits to which the Clause 5.3.7 medical device can be Temperature safely exposed.
  • Page 64 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 the electrode of the test strip. The blood sample is drawn into the tip of the test strip through capillary action.
  • Page 65 References devices on more than one person poses risk for transmitting bloodborne pathogens: initial communication. US Department of Health and Human Services; update 11/29/2010. http:// wayback.archive-it.org/7993/20170111013014/http://www.fda. gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm 2. Centers for Disease Control and Prevention. Infection Prevention during Blood Glucose Monitoring and Insulin Administration.
  • Page 66 of diabetes: Standards of medical care in diabetes—2020. Diabetes Care. 2020;43(supplement 1):S14–S31. 6. International Organization for Standardization / Technical Committee 210. Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1: General requirements. ISO 15223-1:2016. 7.
  • Page 67 No test strip supplier other than the supplier of this product is authorized to grant such a license. Ascensia, the Ascensia Diabetes Care logo, Contour, Microlet, the No Coding logo, Second-Chance, the Second-Chance sampling logo, Smartcolor, and Smartlight are trademarks and/or registered trademarks of Ascensia Diabetes Care Holdings AG.

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