USER GUIDE - Diabetes Blood Glucose Meters And Test Strips

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Blood GlucoseMonitoring SystemWorks with the Contour Diabetes app available for downloadon the App Store or on Google Play . Uses only Contour neXt blood glucose test strips.USER GUIDE

INTENDED USEThe Contour Next ONE blood glucose monitoring system isintended to be used for the quantitative measurement of glucose infresh capillary whole blood drawn from the fingertips or palm. TheContour Next ONE blood glucose monitoring system is intendedto be used by a single person and should not be shared. TheContour Next ONE blood glucose monitoring system is intendedfor self-testing outside the body (in vitro diagnostic use) by peoplewith diabetes at home as an aid in monitoring the effectiveness of adiabetes control program.The Contour Next ONE blood glucose monitoring system shouldnot be used for the diagnosis of or screening for diabetes or forneonatal use. Alternative site testing (palm) should be done onlyduring steady state times (when glucose is not changing rapidly). TheContour Next test strips are for use with the Contour Next ONEblood glucose meter to quantitatively measure glucose in freshcapillary whole blood drawn from the fingertips or palm.The system is intended for in vitro diagnostic use only.iIMPORTANT SAFETY INFORMATIONWARNINGTalk to Your Health Care Professional: Before setting any Target Ranges in the Contour Diabetes app. Before changing your medication based on test results. If your blood sugar reading is under 50 mg/dL follow medicaladvice immediately. If your blood sugar reading is over 250 mg/dL, or the critical levelyou have established with your health care professional:1. Wash and dry your hands well.2. Retest with a new strip.If you get a similar result, call your health care professional assoon as possible. About whether Alternative Site Testing (AST) is appropriate for you.Potential Biohazard Always wash your hands with soap and water and dry them wellbefore and after testing or handling the meter, lancing device, ortest strips. All parts of the kit are considered biohazardous and canpotentially transmit infectious diseases, even after you haveperformed cleaning and disinfection.For complete instructions on cleaning and disinfecting yourmeter and lancing device, see pages 47 to 50. For more information about cleaning and disinfecting your meteror lancing device see: “US Food and Drug Administration. Useof fingerstick devices on more than one person poses risk fortransmitting bloodborne pathogens: initial communication.US Department of Health and Human Services; ces/Safety/AlertsandNotices/ucm224025.htmContour Next ONE blood glucose monitoring systemii

“Centers for Disease Control and Prevention. CDC clinicalreminder: use of fingerstick devices on more than one personposes risk for transmitting bloodborne pathogens. USDepartment of Health and Human Services; ngerstickDevicesBGM.htmlThe meter and lancing device are for single-patient use. Do notshare them with anyone including other family members! Do notuse on multiple patients.1,2The lancing device usually provided with your kit should not beused for assisted blood draws by health care professionals or athealth care provision sites.Always dispose of used test strips and lancets as medical wasteor as advised by your health care professional.All products that come in contact with human blood should behandled as if capable of transmitting infectious diseases.Keep out of reach of children. This kit contains small parts thatcould cause suffocation if accidentally swallowed.Keep batteries away from children. Many types of batteriesare poisonous. If swallowed, immediately contact your poisoncontrol center.LIMITATIONS Serious Illness: The system should not be used to test criticallyill patients and should not be used by persons with reducedperipheral blood flow. Shock, severe hypotension, and severedehydration are examples of clinical conditions that mayadversely affect the measurement of glucose in peripheralblood.3-5 Meter Operating Temperature Range: 41 F–113 F Control Testing Temperature Range: 59 F–95 Fiii Test Strip Storage Conditions: 41 F–86 F, 10%–80% RelativeHumidity (RH) Meter Operating Humidity Range: 10% RH–93% RH Sample Volume: 0.6 μL Measuring Range: 20 mg/dL–600 mg/dL of glucose in blood Altitude: This system has not been tested at altitudes higherthan 20,674 feet (6301 meters). Alternative Site Testing: See Alternative Site Testinginstructions on page 25. Xylose: Do not use during or soon after xylose absorptiontesting. Xylose in the blood will cause an interference. Neonatal Use: The Contour Next ONE meter is not indicatedfor neonatal use.PRECAUTIONSRead your Contour Next ONE user guide, the lancingdevice package insert, if provided, and all instructional materialsprovided in your meter kit before testing. Follow all instructionsfor use and care exactly as described to help avoid inaccurateresults. Examine the product for missing, damaged, or broken parts. Ifthe test strip bottle is open inside a new box of strips, do notuse those strips.For replacement parts, contact Diabetes Care Customer Service.See the back cover for contact information. Your Contour Next ONE meter works ONLY withContour Next test strips and Contour Next control solution. Contour Next ONE blood glucose monitoring systemiv

Always keep the Contour Next test strips in their originalbottle. Tightly close the bottle immediately after removing a teststrip. The bottle is designed to keep the test strips dry. Do notplace 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 leavingthe bottle open or not storing the strips in their original bottlecan damage your test strips. This could lead to inaccurateresults. Do not use a test strip that appears damaged or hasbeen used. Do not use expired materials. Using expired material can causeinaccurate results. Always check the expiration dates on yourtest materials.NOTE: If this is the first time you are opening the control solution,write the date on the bottle. Do not use control solution that is more than 6 months past thedate you first opened the bottle. If your control solution test result is out of range, contactDiabetes Care Customer Service. See the back cover forcontact information. Do not use the meter for blood glucosetesting until you resolve this issue. The meter is designed to give accurate blood testing results attemperatures between 41 F and 113 F. If meter or test strip isoutside this range, you should not test until the meter and teststrip are within this range. Whenever the meter is moved fromone location to another, allow approximately 20 minutes for themeter to adjust to the temperature of the new location beforeperforming a blood glucose test. Do not attempt to perform a blood glucose test when theContour Next ONE meter is connected to a computer. Use only approved equipment from the manufacturer or certifiedbody such as UL, CSA, TUV, or CE.v Your Contour Next ONE meter has been preset and lockedto display results in mg/dL (milligrams of glucose per deciliterof blood).vv Results in mg/dL will never have a decimal point.vv Results in mmol/L will always have a decimal point.orExample:vv Check your display screen to be sure the results are showncorrectly. If not, contact Diabetes Care Customer Service.See the back cover for contact information. The Contour Next ONE blood glucose monitoring system hasa measuring range of 20 mg/dL to 600 mg/dL.vv For results over 600 mg/dL or under 20 mg/dL:oo If your blood sugar reading is under 20 mg/dL, the meterdisplays the LO screen. Contact your health careprofessional immediately.oo If your blood sugar reading is over 600 mg/dL, the meterdisplays the HI screen. Wash your hands or the test site.Repeat the test with a new strip. If results are still over600 mg/dL, follow medical advice immediately.Your Meter FeaturesEasy: The Contour Next ONE blood glucose monitoring system isabout simplicity. You will notice this the first time you use it.Automatic: The Contour Next ONE meter is designed withNo Coding technology, to automatically code itself every time youinsert a test strip. It will also automatically mark a control solution test.Contour Next ONE blood glucose monitoring systemvi

Second-Chance sampling allows blood sample re-application to thesame test strip if the first blood sample is not enough. Your test stripis designed to easily ‘sip’ the blood into the sample tip. Do not dropblood directly on the flat surface of the test strip.Thank you for choosing the Contour Next ONE blood glucosemonitoring system. We are proud to be your partner in helping youmanage your diabetes.CAUTION: Your Contour Next ONE meter works ONLY withContour Next test strips and Contour Next control solution.Ascensia, the Ascensia Diabetes Care logo, Contour,Glucofacts, the No Coding logo, Microlet, and Second-Chanceare trademarks and/or registered trademarks ofAscensia Diabetes Care Holdings AG.Apple and the Apple logo are trademarks of Apple Inc.,registered in the U.S. and other countries. App Store is aservice mark of Apple Inc.The Bluetooth word mark and logos are registeredtrademarks owned by Bluetooth SIG, Inc., and any use of suchmarks by Ascensia Diabetes Care is under license.Google Play and the Google Play logo are trademarks ofGoogle Inc.( registered trademark. unregistered trademark.SM service mark.)All other trademarks are properties of their respective ownersand are used solely for informative purposes. No relationshipor endorsement should be inferred or implied.viiTable of ContentsIntended Use, Important Safety Information.iYour Meter Features. viGETTING STARTEDYour Contour Next ONE meter.3The Contour Diabetes app for Your ONE meter.6Initial Setup from the Contour Diabetes app.7Initial Setup from the Meter.8Target Ranges and Meal Markers .10TESTINGGet Ready to Test.12Get the Blood Drop: Fingertip Testing.17Select a Meal Marker.19About Meal Markers.23Turn Meal Markers On.23Test Results.24Expected Test Result Values.24LO or HI Results.25Alternative Site Testing (AST): Palm.25Control Solution Testing.33FEATURESLogbook.36Settings.37Pairing Mode.46HELPMeter Care.46Transfer Results to the Contour Diabetes app.50Transfer Results to a Personal Computer.50Batteries.51TECHNICAL INFORMATIONError Detection Displays.53Customer Service Checklist.55Technical Information.56Contour Next ONE blood glucose monitoring system1

GETTING STARTEDSymptoms of High or Low Blood Glucose.59Specifications.61Warranty.64Index.66Your Contour Next ONE meterUp Button Press to scroll up Press and hold tokeep scrollingOK Button Press and holdto turn the meterOn or Off Press to accepta selectionTest Strip PortDown Button Press to scroll down Press and hold tokeep scrollingUp/Down Scroll ButtonsUsing the Meter ButtonsPress and hold the OK button until the meter turns On.Press and hold the OK button until the meter turns Off.The or buttons on the meter allow you to scroll through theoptions. You can hold the or button to scroll continuouslythrough a list.Press the OK button to accept a selection.To exit from the Logbook or the last Settings screen and return toHome, press the OK button.NOTE: The meter screen dims after 30 seconds of inactivity. Pressany button to bring up the screen.2Contour Next ONE blood glucose monitoring system3

GETTING STARTEDYour Contour Next ONE meter ScreenSymbolTimeTest Result in TargetWhat the Symbol MeansNo marker selected.A Target Range or Target setting.MealMarkerTarget Light (smartLIGHT) setting.Meter is ready to test.Add more blood to strip.Test Strip PortDateControl solution result.Bluetooth symbol: indicates the Bluetooth setting is On;the meter can communicate with a mobile device.SymbolWhat the Symbol MeansIndicates low batteries.Blood sugar test result is in Target Range.Indicates dead batteries.Blood sugar test result is above 600 mg/dL.Indicates a meter error.Blood sugar test result is below 20 mg/dL.Blood sugar test result is above Target Range.Blood sugar test result is below Target Range.Logbook entry.Meter Settings.Fasting marker.Before Meal marker.After Meal marker.4Contour Next ONE blood glucose monitoring system5

GETTING STARTEDYour Contour Next test stripGrey Square End:Insert this end into the test strip portSample Tip:Blood sample pulled in hereThe Contour Diabetes app for Your ONE meterYour Contour Next ONE meter was designed to work with theContour 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.oo List meals containing carbs.oo Note changes in medication.oo Add photos of your meal.oo Log an increase or decrease in activity. Set testing reminders. Access easy-to-read graphs of test results over a day or over aperiod of time.6 Share reports. Discreetly view information. Review your Fasting, Before Meal, After Meal, and Overall resultson a daily graph. Change meter settings, as necessary.The Contour Diabetes app does these things for you: Automatically displays your results. Saves your Notes in the Logbook. Displays your Trends and test results as they compare with yourtargets.Download the Contour Diabetes app1. On your smartphone or tablet, go to the App Store or theGoogle Play store.2. Search for the Contour Diabetes app.3. Install the Contour Diabetes app.ORScan with QR Code app or visitwww.contourone.com tolearn more.Initial Setup from the Contour Diabetes appThe easiest way to set up your new meter is to download theContour Diabetes app to your smartphone or tablet and follow theinstructions in the app.If you do not pair your meter with the Contour Diabetes app, followthe instructions in Initial Setup from the Meter the first time you turn onyour meter.Contour Next ONE blood glucose monitoring system7

GETTING STARTEDInitial Setup from the MeterSet the TimeThe hour is blinking.OK Button1. To change the hour, press thePress and hold the OK button for 2 seconds until the meter turns on.orbutton on the outer ring.Outer RingThe screen displays the Power On Self Test.All symbols on the screen and the white strip port briefly light up. It isvery important to verify that 8.8.8 displays fully and that the white lightfrom the test strip port is visible.If there are missing characters or if the strip port light is a color otherthan white, contact Diabetes Care Customer Service. This may affectthe way you see your results.Initial Setup begins with View Pre-Set Target.2. To set the hour and move tominutes, press the OK button.3. To change the minutes, pressthe or button on the outerring, then press the OK button.For a 12-hour format, select AMor PM, press the or button,then press the OK button.Continue to Set the Date.View Pre-Set TargetThe meter displays a pre-set OverallTarget Range. You can changethis pre-set Target Range fromthe Contour Diabetes app afterinitial setup.To move to the next screen, pressthe OK button. Continue to Setthe Time.8Contour Next ONE blood glucose monitoring system9

GETTING STARTEDSet the DateThe year is blinking.1. To change the year, press theOK button.orAbove Your Target Range.button, then press theBelow Your Target Range.2. To change the month, press the or button, then press theOK button.3. To change the day, press the or button, then press theOK button.The meter briefly displays your saved settings, then beeps andturns OFF.Setup is complete. You are ready to test your blood.Target Ranges and Meal MarkersThe meter compares your blood sugar results with a Target Range(for example, 70 mg/dL–130 mg/dL) to let you know if your testresult is:your Target Range. withinyour Target Range. aboveyour Target Range. belowYou can attach a Meal Marker to your blood sugar result using theMeal Marker feature in the meter. This feature lets you track yourblood sugar levels over time with separate target ranges for Fasting,Before Meal, and After Meal markers. If you mark your test result as Fasting, the meter compares yourresult against the Fasting Target Range. If you mark your test result as Before Meal, the meter comparesyour result against the Before Meal Target Range. If you mark your result as After Meal, the meter compares theresult against the After Meal Target Range. If you do not mark the result, the meter compares your test resultagainst the Overall Target Range.SymbolTarget RangePre-set Fasting Target Range: 70 mg/dL – 130 mg/dLPre-set Before Meal Target Range: 70 mg/dL – 130 mg/dLPre-set After Meal Target Range: 70 mg/dL – 180 mg/dLPre-set Overall Target Range: 70 mg/dL – 180 mg/dLWithin Your Target Range.10Your Contour Next ONE meter comes with Meal Markersturned Off.Contour Next ONE blood glucose monitoring system11

TESTINGYou can change the time format, time, date format, date, Soundsetting, Meal Marker setting, and the Target Light (smartLIGHT)setting by going to the Home screen and selecting Settings .See page 37.Get Ready to TestRead your Contour Next ONE user guide, the lancing devicepackage insert, if provided, and all instructional materials provided inyour meter kit before testing. Follow all instructions for use and careexactly as described to help avoid inaccurate results.Examine the product for missing, damaged, or broken parts. If the teststrip bottle is open inside a new box of strips, do not use those strips.For replacement parts, contact Diabetes Care Customer Service. Seethe back cover for contact information.CAUTION: Your Contour Next ONE meter works only withContour Next test strips and Contour Next control solution.Fingertip TestingEnsure that you have the materials you need before you begin testing: Contour Next ONE meter. Contour Next test strips. Lancing device and lancets from your kit, if provided.To perform a quality control check, you also need Contour Next controlsolution. Some supplies are sold separately. Contact Di

contact information. Do not use the meter for blood glucose testing until you resolve this issue. The meter is designed to give accurate blood testing results at temperatures between 41 F and 113 F. If meter or test strip is outside this range, you should not test until the meter and test strip are within this range.

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