Blood Glucose Monitoring System Works with the CONTOUR™DIABETES app available for download on the App Store or on Google Play™. ® Uses only CONTOUR®NEXT blood glucose test strips. USER GUIDE 85025015_CntrNxtONE_UG_EN.indd 1 PROCESS C PROCESS M PROCESS Y 8/18/16 10:14 AM PROCESS K FILE NAME: 85025015_CntrNxtONE_UG_EN.indd DESCRIPTION: Onyx Contour NEXT ONE Meter User Guide 5050 1st Ave South Suite #101 Seattle, WA 98134 Tel: 206.587.0800 Fax: 206.587.
INTENDED USE The CONTOUR®NEXT ONE blood glucose monitoring system is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or palm. The CONTOUR NEXT ONE blood glucose monitoring system is intended to be used by a single person and should not be shared.
• • • • • • “Centers for Disease Control and Prevention. CDC clinical reminder: use of fingerstick devices on more than one person poses risk for transmitting bloodborne pathogens. US Department of Health and Human Services; 8/23/2010.” http://www.cdc.gov/injectionsafety/FingerstickDevicesBGM.html 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.
• Always keep the CONTOUR NEXT test strips in their original bottle. Tightly close the bottle immediately after removing a test strip. The bottle is designed to keep the test strips dry. Do not place or store other items or medications in the test strip bottle. Avoid exposing meter and test strips to excessive humidity, heat, cold, dust, or dirt. Exposure to room humidity by leaving the bottle open or not storing the strips in their original bottle can damage your test strips.
Second-Chance® sampling allows blood sample re-application to the same test strip if the first blood sample is not enough. Your test strip is designed to easily ‘sip’ the blood into the sample tip. Do not drop blood directly on the flat surface of the test strip. Thank you for choosing the CONTOUR NEXT ONE blood glucose monitoring system. We are proud to be your partner in helping you manage your diabetes.
GETTING STARTED Symptoms of High or Low Blood Glucose.................................59 Specifications .............................................................................61 Warranty .....................................................................................64 Index ..........................................................................................
GETTING STARTED Your CONTOUR NEXT ONE meter Screen Symbol Time Test Result in Target What the Symbol Means No marker selected. A Target Range or Target setting. Meal Marker Target Light (smartLIGHT) setting. Meter is ready to test. Add more blood to strip. Test Strip Port Date Control solution result. Bluetooth® symbol: indicates the Bluetooth setting is On; the meter can communicate with a mobile device. Symbol What the Symbol Means Indicates low batteries.
GETTING STARTED Your CONTOUR NEXT test strip Grey Square End: Insert this end into the test strip port Sample Tip: Blood sample pulled in here The CONTOUR™DIABETES app for Your ONE meter Your CONTOUR NEXT ONE meter was designed to work with the CONTOUR DIABETES app and your smartphone or tablet. You can do the following things with your CONTOUR DIABETES app: • Perform your initial meter setup. • Add Notes after testing that help to explain your results. o List meals containing carbs.
GETTING STARTED Initial Setup from the Meter Set the Time The hour is blinking. OK Button 1. To change the hour, press the Press and hold the OK button for 2 seconds until the meter turns on. or button on the outer ring. Outer Ring The screen displays the Power On Self Test. All symbols on the screen and the white strip port briefly light up. It is very important to verify that 8.8.8 displays fully and that the white light from the test strip port is visible.
GETTING STARTED Set the Date The year is blinking. 1. To change the year, press the OK button. or Above Your Target Range. button, then press the Below Your Target Range. 2. To change the month, press the or button, then press the OK button. 3. To change the day, press the or button, then press the OK button. The meter briefly displays your saved settings, then beeps and turns OFF. Setup is complete. You are ready to test your blood.
TESTING You can change the time format, time, date format, date, Sound setting, Meal Marker setting, and the Target Light (smartLIGHT) setting by going to the Home screen and selecting Settings . See page 37. Get Ready to Test Read your CONTOUR NEXT 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.
TESTING 4. Twist off the round protective lancet cap. Save the cap for disposing of the used lancet. 1. Remove the endcap from the lancing device. 14 85025015_CntrNxtONE_UG_EN.indd 14-15 2. Loosen the round protective cap on a lancet by rotating the cap ¼ turn, but do not remove the cap. 5. Replace the endcap. 3. Insert the lancet firmly into the lancing device until the lancet comes to a complete stop. 6. Rotate the endcap dial to adjust the puncture depth.
TESTING Insert the Test Strip Get the Blood Drop: Fingertip Testing CAUTION: Do not use expired materials. Using expired material can cause inaccurate results. Always check the expiration dates on your test materials. 1. Remove a CONTOUR NEXT test strip from the bottle. 2. Tightly close the bottle lid immediately after you have removed the test strip. 3. Hold the test strip with the grey square end facing toward the meter. 4.
TESTING Select a Meal Marker CAUTION: Do not press the tip of the test strip against the skin or place the blood on top of the test strip. These actions could lead to inaccurate results or errors. NOTE: During a blood sugar test, if Meal Markers are On, you can select a Meal Marker when the meter displays your result. You cannot select a Meal Marker in the Settings screen.
TESTING Meal Marker choices if Meal Marker feature is On Symbol What the Symbol Means Fasting: Use the Fasting marker when testing blood sugar levels after fasting (no food or drink for 8 hours, except water or non-caloric beverages). Before Meal: Use the Before Meal marker when testing blood sugar levels within 1 hour before a meal. After Meal: Use the After Meal marker when testing blood sugar levels within 2 hours after the first bite of a meal.
TESTING If the Target Light (smartLIGHT) setting is On, the test strip port displays a color representing your result value compared to the Before Meal, After Meal, or Overall Target Range. About Meal Markers During a blood sugar test, you can attach a Meal Marker to your blood sugar result when the Meal Marker feature in the meter is turned On. This feature lets you track your blood sugar levels over time with separate Target Ranges for Fasting, Before Meal, and After Meal markers.
TESTING Test Results LO or HI Results WARNING • Always consult your health care professional before changing your medication based on test results. • If your blood sugar reading is under 50 mg/dL, follow medical advice immediately. • If your blood sugar reading is over 250 mg/dL: 1. Wash and dry your hands well. 2. Retest with a new strip. If you get a similar result, call your health care professional as soon as possible.
TESTING For Alternative Site Testing, use the clear endcap. Your CONTOUR NEXT ONE meter can be used for fingertip or palm testing. See the lancing device insert for detailed instructions on Alternative Site Testing. Do not use AST under the following conditions: • If you think your blood sugar is low. • When blood sugar is changing rapidly, such as after a meal, after an insulin dose, or during or after exercise. • If you are unable to feel symptoms of low blood sugar (hypoglycemic unawareness).
TESTING Apply More Blood for Alternative Site Testing 1. If the meter beeps twice and the screen displays a blinking blood drop, the test strip does not have enough blood. 6. Lift the lancing device straight up and away from the skin without smearing the blood. 7. Test immediately after you have formed a small, round blood drop, as shown. Immediately touch the tip of the test strip to the drop of blood. The blood is drawn into the test strip through the tip.
TESTING Meal Marker choices if Meal Marker feature is On Symbol What the Symbol Means Fasting: Use the Fasting marker when testing blood sugar levels after fasting (no food or drink for 8 hours, except water or non-caloric beverages). Before Meal: Use the Before Meal marker when testing blood sugar levels within 1 hour before a meal. After Meal: Use the After Meal marker when testing blood sugar levels within 2 hours after the first bite of a meal.
TESTING Control Solution WARNING WARNING Shake the control solution well before testing. CAUTION: Use only CONTOUR NEXT control solution (Level 1 and Level 2) with your CONTOUR NEXT ONE blood glucose monitoring system. Using anything other than CONTOUR NEXT control solution can cause inaccurate results. Quality Control • Shake the control solution bottle well, about 15 times before every use. • Unmixed control solution may cause inaccurate results.
TESTING 8. Immediately touch the tip of the test strip to the drop of control solution. 4. Insert the grey square end of the test strip into the test strip port until the meter beeps. The meter turns on, displaying a test strip with a flashing blood drop. CAUTION: Do not use control solution that is more than 6 months past the date you first opened the bottle. 9. Hold the tip in the drop until the meter beeps. The meter counts down for 5 seconds before the control test result displays on the meter.
FEATURES Logbook Settings The Logbook contains blood sugar test results and markers that you have made to those test results. The Logbook holds up to 800 results. When the Logbook reaches the maximum, the oldest test result will be removed as a new test is completed and saved to the Logbook. In Settings you can: Review the Logbook NOTE: To return to the Home screen while viewing the Logbook, press the OK button. To review entries in the Logbook: 1.
FEATURES Change the Time The time format is blinking. 1. To change the time format, if needed, press the then press the OK button. 4. Continue to press the OK button until you see the Date Format screen. or button, or Time Format The hour is blinking. 2. To change the hour, press the or button, then press the OK button. The minutes are blinking. 3. To change minutes, press the or button, then press the OK button. 4. For a 12-hour time format, select AM or PM, as needed, then press the OK button.
FEATURES Set the Sound Set Meal Markers If your meter is not ON: 1. Press and hold the OK button until the meter turns on. and Settings The Home screen has 2 options: Logbook If your meter is not ON: 1. Press and hold the OK button until the meter turns on. and Settings The Home screen has 2 options: Logbook . 2. To highlight the Settings symbol , press the button. 3. When the Settings symbol is blinking, press the OK button to enter Settings. 4.
FEATURES View Target Ranges 7. To move to the next Target Range, press the OK button. WARNING Discuss your Target Range settings with your health care professional. When the Meal Marker feature is On, your meter displays a Fasting, Before Meal, After Meal, and Overall Target Range. You can change these ranges only in the CONTOUR DIABETES app. If your meter is not ON: 1. Press and hold the OK button until the meter turns on.
FEATURES If your meter is not ON: 1. Press and hold the OK button until the meter turns on. and Settings . The Home screen has 2 options: Logbook 2. To highlight the Settings symbol , press the button. 3. When the Settings symbol is blinking, press the OK button to enter Settings. 4. Continue to press the OK button until you see the Target Lights screen. or Set Bluetooth Bluetooth is not available until you pair your meter with a mobile device. After pairing, the Bluetooth setting is turned ON.
HELP Pairing Mode To pair your meter with the CONTOUR DIABETES app, download the app and follow the instructions to Pair a Meter. To put your meter in pairing mode: • Turn your meter off. • Press and do not release the OK button. • Continue to hold the OK button while all symbols on the screen and the white strip port briefly light up. • Release the OK button when you see a flashing blue light from the test strip port. The Bluetooth icon is blinking and the meter serial number displays.
HELP Clorox Germicidal Wipes are available for purchase online at http://www.officedepot.com or http://www.amazon.com. For more information, contact Diabetes Care Customer Service. See the back cover for contact information. • Cleaning involves the removal of visible dirt and debris, but does not reduce the risk for transmission of infectious diseases. • Disinfecting (if performed properly) reduces the risk of transmitting infectious diseases.
HELP 3. After wiping for 60 seconds, use a clean paper towel to dry the meter surfaces and the test strip port. CAUTION: Use only approved equipment from the manufacturer or certified body such as UL, CSA, TUV, or CE. 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.
TECHNICAL INFORMATION 3. Remove both of the old batteries and replace them with two 3-volt CR2032 or DL2032 coin cell 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. 4. Make sure the ‘+’ sign is facing down on the new batteries. 5.
TECHNICAL INFORMATION Error Code What it Means E25 Too Hot to Test Control Solution E27 Too Cold to Test E28 Too Hot to Test What to Do Move the meter, strip, and control solution to a cooler area. Test in 20 minutes. Move the meter and strip to a warmer area. Test in 20 minutes. Move the meter and strip to a cooler area. Test in 20 minutes. Customer Service Checklist When speaking with the Diabetes Care Customer Service representative: 1.
TECHNICAL INFORMATION Technical Information: User Accuracy Technical Information: Precision The CONTOUR NEXT ONE blood glucose monitoring system was tested by 372 lay users using capillary blood samples and three CONTOUR NEXT test strip lots. The results were compared to the YSI Glucose Analyzer laboratory reference method, traceable to the CDC hexokinase method. The following accuracy results were obtained.
TECHNICAL INFORMATION Table 2: System intermediate precision results for CONTOUR NEXT ONE meter using CONTOUR NEXT test strips Control Level Mean, mg/dL Pooled Standard Deviation, mg/dL 1 2 3 42.0 123.6 363.1 0.6 1.5 5.4 95% CI of SD, mg/dL Coefficient of Variation, % 0.55–0.65 1.38–1.63 4.97–5.89 1.4 1.2 1.5 Symptoms of High or Low Blood Glucose You can better understand your test results by being aware of the symptoms of high or low blood glucose.
TECHNICAL INFORMATION Federal Communications Commission (FCC) Certified Device 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.
TECHNICAL INFORMATION Electromagnetic Compatibility (EMC): The CONTOUR NEXT ONE meter complies with the electromagnetic requirements specified in IEC 60601-1-2 Edition 4.0. 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 CONTOUR NEXT ONE meter. The CONTOUR NEXT ONE meter meets the requirements of IEC 61000-4-2 for immunity to electrostatic discharge.
TECHNICAL INFORMATION 6. American Diabetes Association. Standards of medical care in diabetes—2016. Diabetes Care. 2016;39(supplement 1):S15. 7. Burtis CA, Ashwood ER, editors. Tietz Fundamentals of Clinical Chemistry. 5th edition. Philadelphia, PA: WB Saunders Co; 2001;444. Manufacturer’s Warranty: Ascensia Diabetes Care warrants to the original purchaser that this instrument will be free from defects in materials and workmanship for 5 years from the date of original purchase (except as noted below).
Index After Meal Marker ....................................................... 4, 19, 20, 29, 30 Alternative Site Testing (AST) ........................................................... 25 Batteries ....................................................................................... 5, 51 Low Batteries ........................................................................ 5, 51 Replacement ............................................................................. 51 Before Meal Marker ...........
Distributed by: Ascensia Diabetes Care US, Inc. 5 Wood Hollow Road Parsippany, NJ 07054 USA www.contourone.com 1-800-348-8100 Customer Service is available Monday through Sunday, 8:00 am through Midnight, Eastern Time www.contourone.com For information on patents and related licenses, see www.patents.ascensia.com. Purchase of this product does not alone confer a license to use under these patents.
