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Contact Diabetes Care Customer Service at 1-800-268-7200.

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.
Such a license only arises, and extends only to, when the C

ONTOUR

N

EXT

ONE meters

and C

ONTOUR

N

EXT

test strips are used together. 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, Glucofacts, Microlet,
the No Coding logo, and Second-Chance are trademarks and/or registered trademarks
of Ascensia Diabetes Care Holdings AG.
TM see www.ascensiadiabetes.ca/en/tm-mc

Apple and the Apple logo are trademarks of Apple Inc., registered in the U.S. and other
countries. App Store is a service mark of Apple Inc.
The

Bluetooth

®

word mark and logos are registered trademarks owned by Bluetooth

SIG, Inc., and any use of such marks by Ascensia Diabetes Care is under license.
Google Play and the Google Play logo are trademarks of Google Inc.

(

®

= registered trademark.

TM

= unregistered trademark.

SM

= service mark.)

All other trademarks are properties of their respective owners and are used solely for
informative purposes. No relationship or endorsement should be inferred or implied.

Manufactured for:

Ascensia Diabetes Care Holdings AG

Peter Merian-Strasse 90

4052 Basel, Switzerland

www.contourone.com

© 2016 Ascensia Diabetes Care Holdings AG.

All rights reserved.

85096877 Rev. 09/16

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Summary of Contents for ONE

Page 1: ...USER GUIDE Uses only CONTOUR NEXT blood glucose test strips Blood Glucose Monitoring System Works with the CONTOUR DIABETES app available for download on the App StoreSM or on Google Play ...

Page 2: ...insulin and non insulin treated diabetes and or their caregivers to store view trend and share blood glucose meter readings either manually entered in the app or wirelessly transmitted from the CONTOUR family of meters Other related health indicators which can be captured and shown in a printable report and graphical format on a mobile device for insulin and non insulin treated patients with diabe...

Page 3: ...tions for use and care exactly as described to help avoid inaccurate results Examine the product for missing damaged or broken parts If the test strip bottle is open inside a new box of strips do not use those strips For replacement parts contact Diabetes Care Customer Service See the back cover for contact information Your CONTOUR NEXT ONE meter works ONLY with CONTOUR NEXT test strips and CONTOU...

Page 4: ...ver for contact information The CONTOUR NEXT ONE blood glucose monitoring system has a measuring range of 0 6 mmol L to 33 3 mmol L v For results over 33 3 mmol L or under 0 6 mmol L o If your blood sugar reading is under 0 6 mmol L the meter displays the LO screen Contact your health care professional immediately o If your blood sugar reading is over 33 3 mmol L the meter displays the HI screen W...

Page 5: ...dorsement should be inferred or implied vii 1 CONTOUR NEXT ONE blood glucose monitoring system Table of Contents Intended Use Important Safety Information i Your Meter Features vi GETTING STARTED Your CONTOUR NEXT ONE meter 3 The CONTOUR DIABETES app for Your ONE meter 6 Initial Setup from the CONTOUR DIABETES app 7 Initial Setup from the Meter 8 Target Ranges and Meal Markers 10 TESTING Get Ready...

Page 6: ... keep scrolling Up Down Scroll Buttons Using the Meter Buttons Press 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 the options You can hold the or button to scroll continuously through a list Press the OK button to accept a selection To exit from the Logbook or the last Settings screen ...

Page 7: ...bove Target Range Blood sugar test result is below Target Range Logbook entry Meter Settings Fasting marker Before Meal marker After Meal marker 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 co...

Page 8: ...ore Meal After Meal and Overall results on 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 your targets Offers quick and valuable tips to help you manage your diabetes Download the CONTOUR DIABETES app 1 On your smartphon...

Page 9: ... This may affect the way you see your results Initial Setup begins with View Pre Set Target View Pre Set Target The meter displays a pre set Overall Target Range You can change this pre set Target Range from the CONTOUR DIABETES app after initial setup To move to the next screen press the OK button Continue to Set the Time Set the Time The hour is blinking 1 To change the hour press the or button ...

Page 10: ... your blood sugar result using the Meal Marker feature in the meter This feature lets you track your blood 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 your result against the Fasting Target Range If you mark your test result as Before Meal the meter compares your result against the Befo...

Page 11: ... supplies are sold separately Contact Diabetes Care Customer Service See the back cover for contact information 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 page 47 Always wash your hands with soap and water and dry them well before and after testing or handl...

Page 12: ...the cap 3 Insert the lancet firmly into the lancing device until the lancet comes to a complete stop 4 Twist off the round protective lancet cap Save the cap for disposing of the used lancet 5 Replace the endcap 6 Rotate the endcap dial to adjust the puncture depth The amount of pressure applied to the puncture site also affects puncture depth 85096877_CntrNxtONE_UG_EN indd 14 15 9 21 16 3 47 AM ...

Page 13: ...p indicating it is ready to test a blood drop NOTE After you insert the test strip apply blood to the test strip within 3 minutes or the meter turns off Remove the test strip and reinsert it to begin a test Get the Blood Drop Fingertip Testing NOTE For Alternative Site Testing instructions see page 25 1 Press the lancing device firmly against the puncture site and press the release button 2 Stroke...

Page 14: ...ess the OK button or Outer Ring 2 To select another Meal Marker press the or button on the outer ring to scroll between markers 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 5 Hold the tip of the test strip in the blood drop until the meter beeps NOTE If Meal Marker feature is On ...

Page 15: ... use the CONTOUR DIABETES app Example Blood test result with Meal Markers Off or marker not selected Meal Marker choices if Meal Marker feature is On Symbol What the Symbol Means Related Target Range 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 Fasting Target Range Before Meal Use the Before Meal mar...

Page 16: ... Settings Set Meal Markers on page 41 NOTE You can select a Meal Marker only when the blood sugar test result displays on the screen If the Target Light smartLIGHT setting is On the test strip port displays a colour representing your result value compared to the Before Meal After Meal or Overall Target Range In Target Below Target Above Target If your blood sugar result is below target the Target ...

Page 17: ...r hands with soap and water and dry them well before and after testing or handling the meter lancing device or test strips Test Results WARNING Always consult your health care professional before changing your medication based on test results If your blood sugar reading is under 2 8 mmol L follow medical advice immediately If your blood sugar reading is over 13 9 mmol L 1 Wash and dry your hands w...

Page 18: ...itions 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 If you get alternative site blood sugar results that do not agree with how you feel During illness or times of stress If you will be driving a car or operating machinery...

Page 19: ...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 2 Apply more blood to the test strip within 60 seconds 3 If the screen displays an E 1 error message remove the strip and start with a new strip If the Meal Marker feature is On the meter suggests a Fasting Before Meal After Meal or No Mark mark...

Page 20: ...a Meal Marker on page 19 Eject and Dispose of the Used Lancet 1 Do not use your fingers to remove the lancet from the lancing device The lancing device provided with your kit has an automatic lancet ejection feature 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 ...

Page 21: ...ntinuous glucose monitoring device from the control result Do not calculate a bolus based on a control result CAUTION Do not use expired materials Using expired material can cause inaccurate results Always check the expiration dates on your test materials Normal Low or High control solutions are available and sold separately if not included in the meter kit You can test your CONTOUR NEXT ONE meter...

Page 22: ...strip to the drop of control solution 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 The meter automatically marks the result as a control test Control test results are not included in your meter Logbook in blood sugar averages or in targets in the CONTOUR DIABETES app 10 Compare your control test result wit...

Page 23: ...oll faster press and hold the or button If you scroll past the oldest entry the meter displays the End screen If you see a LO or HI test result go to page 25 for more information 5 To go back to the beginning to review entries press the OK button to go to the Home screen then select the Logbook symbol Settings In Settings you can Change the time format Change the time Change the date format Change...

Page 24: ...ound screen Change the Time The time format is blinking 1 To change the time format if needed press the or button then press the OK 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 ...

Page 25: ... want 6 Press the OK button NOTE Some sounds remain On even when you turn the Sound feature Off To turn sounds Off for a below target blood sugar reading turn the Target Light setting to Off The meter displays the Meal Marker screen Set Meal Markers If your meter is not ON 1 Press and hold the OK button until the meter turns on The Home screen has 2 options Logbook and Settings 2 To highlight the ...

Page 26: ... move to the next Target Range press the OK button The meter displays the Before Meal Target Range 6 To move to the next Target Range press the OK button The meter displays the After Meal Target Range 7 To move to the next Target Range press the OK button The meter displays the Overall Target Range 8 To move to the next screen press the OK button When the Meal Marker feature is Off your meter disp...

Page 27: ...et Bluetooth Bluetooth is not available until you pair your meter with a mobile device After pairing the Bluetooth setting is turned ON If your meter is not ON 1 Press and hold the OK button until the meter turns on 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 the OK button to enter Settings 4 Co...

Page 28: ...damage or degradation to the external case buttons or display Your CONTOUR NEXT ONE meter has been tested for 260 cycles of cleaning and disinfection equivalent to one cycle per week for 5 years This device has been demonstrated to withstand 5 years of cleaning and disinfection without damage You should call Diabetes Care Customer Service for assistance if your device malfunctions for any reason o...

Page 29: ...reas such as around the buttons or the meter s test strip or data ports 1 Carefully clean the meter with germicidal wipes until all soil is removed 2 Dry as necessary with a clean paper towel Disinfecting Your Meter Supplies needed for disinfecting Clorox Healthcare Professional Disinfecting Bleach Wipes containing 0 55 sodium hypochlorite bleach Paper towels Timing device 1 Before disinfecting cl...

Page 30: ...ement software and a 1 meter or 3 foot long USB A to Micro USB B cable This type of cable is available in electronics retail stores For a free download of the software go to www glucofacts ascensia com CAUTION Use only approved equipment from the manufacturer or certified body such as UL CSA TUV or CE Batteries When the batteries are low the Low Batteries symbol displays on every screen Replace th...

Page 31: ...lays 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 the OK button to turn off the meter If you experience continued errors contact Diabetes Care Customer Service See the back cover for contact information Error Code What it Means What to Do Strip Errors E 1 Too Little Blood Remove the st...

Page 32: ...tion Customer Service Checklist When speaking with the Diabetes Care Customer Service representative 1 Have your CONTOUR NEXT ONE blood glucose meter CONTOUR NEXT test strips and CONTOUR NEXT control solution available when you call 2 Locate the model number A and serial number B on the back of the meter 3 Locate the test strips expiration date on the bottle 4 Check the battery status Parts Inform...

Page 33: ...tion 5 55 mmol L Difference range in values between YSI laboratory reference method and CONTOUR NEXT ONE meter Within 5 Within 10 Within 15 Number and percent of samples within specified range 257 of 390 65 9 380 of 390 97 4 390 of 390 100 Table 3 System accuracy results for glucose concentrations between 2 0 mmol L and 35 7 mmol L Within 0 83 mmol L or 15 600 of 600 100 Acceptance criterion in IS...

Page 34: ... to the laboratory value The data points inside the bold green outer circle represent readings within 0 83 mmol L for values 5 55 mmol L or 15 error for values 5 55 mmol L versus laboratory reference to demonstrate how the BGMS compares to the ISO 15197 2013 accuracy requirements Technical Information Precision A measurement repeatability study was conducted with the CONTOUR NEXT ONE blood glucose...

Page 35: ...n symptoms are Low blood glucose Hypoglycemia shakiness sweating fast heartbeat blurred vision confusion passing out seizure irritability extreme hunger dizziness High blood glucose Hyperglycemia frequent urination excessive thirst blurred vision increased fatigue hunger Ketones Ketoacidosis shortness of breath nausea or vomiting very dry mouth WARNING If you are experiencing any of these symptoms...

Page 36: ...tic discharge Avoid use of electronic devices in very dry environments especially if synthetic materials are present The CONTOUR NEXT ONE meter meets the requirements of IEC 61326 1 for radio frequency interference To avoid radio frequency interference do not use the CONTOUR NEXT ONE meter near electrical or electronic equipment that are sources of electromagnetic radiation as these may interfere ...

Page 37: ... sc 2009 13372a eng php 6 Burtis CA Ashwood ER editors Tietz Fundamentals of Clinical Chemistry 5th edition Philadelphia PA WB Saunders Co 2001 444 Principles of the Procedure The CONTOUR NEXT 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 t...

Page 38: ...f this instrument without obligation to incorporate such changes into previously manufactured instruments 4 Ascensia Diabetes Care has no knowledge of the performance of the CONTOUR NEXT ONE blood glucose meter when used with any test strips other than CONTOUR NEXT test strips and therefore does not warrant the performance of the CONTOUR NEXT ONE meter when used with any test strips other than CON...

Page 39: ...68 69 CONTOUR NEXT ONE blood glucose monitoring system 85096877_CntrNxtONE_UG_EN indd 68 69 9 21 16 3 47 AM ...

Page 40: ...ion 13 LO or HI Results 25 Logbook 36 Meal Markers About 23 Meal Markers Turn On 23 Meter Care 46 Meter Symbols 4 5 Pairing Mode 46 Settings 37 Bluetooth 45 Date 38 Meal Markers 41 Sound 40 Target Lights 43 Time 38 Specifications 62 Symptoms of High or Low Blood Glucose 60 Target Ranges Before Meal After Meal Overall 42 Target Settings 8 42 Technical Information 53 Testing Your Blood Sugar 12 Afte...

Page 41: ...s AG TM see www ascensiadiabetes ca en tm mc Apple and the Apple logo are trademarks of Apple Inc registered in the U S and other countries App Store is a service mark of Apple Inc The Bluetooth word mark and logos are registered trademarks owned by Bluetooth SIG Inc and any use of such marks by Ascensia Diabetes Care is under license Google Play and the Google Play logo are trademarks of Google I...

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