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Contour NEXT ONE User Manual Download Page 39

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 blood glucose monitoring system

TECHNICAL INFORMATION

Hereby, Ascensia Diabetes Care declares that the radio equipment 

type Blood Glucose Meter is in compliance with Directive 2014/53/EU.

The full text of the EU declaration of conformity is available at the 

following internet address:  

www.diabetes.ascensia.com/declarationofconformity

Product Labeling Symbols

The following symbols are used throughout the product labeling for  

the C

ontour

 n

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 blood glucose monitoring system (meter 

packaging and labeling, and test strip and control solution packaging 

and labeling).

Symbol

What It Means

Use by date (last day of the month)
Warning, improper use could result in injury or 

illness.
Do not reuse
Sterilized using irradiation
Batch Code

Discard

Date:

Control Discard Date

Temperature limitations

Consult instructions for use
In Vitro Diagnostic Medical Device
Manufacturer

Symbol

What It Means

Catalogue number
Control Range Low
Control Range Normal
Control Range High
Shake 15 times

Number of test strips included
Batteries must be disposed of in accordance with 

laws in your country. Contact your competent 

local authority for information on the relevant laws 

regarding disposal and recycling in your area.

The meter should be treated as contaminated 

and disposed of according to local safety rules. It 

should not be disposed of with waste electronic 

equipment.

Contact your health care professional or local 

waste disposal authority for medical waste disposal 

guidelines.

Principles of the Procedure: The C

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 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. Glucose in the sample reacts with FAD glucose dehydrogenase 

(FAD-GDH) and the mediator. Electrons are generated, producing 

a current that is proportional to the glucose in the sample. After the 

reaction time, the glucose concentration in the sample is displayed. No 

calculation by the user is required.

Summary of Contents for NEXT ONE

Page 1: ...0 22 7 18 52 USER GUIDE Uses only Contour Next blood glucose test strips Works with the Contour Diabetes app available for download from the App StoreSM or on Google PlayTM Blood Glucose Monitoring System ...

Page 2: ...iohazard Always wash your hands with antibacterial soap and water and dry them well before and after testing or handling the meter lancing device or test strips INTENDED USE The Contour Next 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 HCPs in monitoring th...

Page 3: ...in your meter kit before testing Follow all instructions 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 Customer Service See the back cover for contact information Your Contour Next meter works ONLY with Co...

Page 4: ...ur Next blood glucose monitoring system has a measuring range of 0 6 mmol L to 33 3 mmol L For results under 0 6 mmol L or over 33 3 mmol L If your blood glucose reading is under 0 6 mmol L the meter displays the LO screen Contact your health care professional immediately If your blood glucose reading is over 33 3 mmol L the meter displays the HI screen Wash your hands or the test site Repeat the ...

Page 5: ...ce 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 Table of Contents INTENDED USE i IMPORTANT SAFETY INFORMATION ii Your Meter Features vi GETTING STARTED Your Contour Next meter 3 Check the Meter Display 6 Target Ranges 7 Meal Markers 8 TESTING Get Ready to Test 9 Get the ...

Page 6: ...rough 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 Averages and return to the Home screen press the OK button NOTE When a symbol is blinking you can select it The Contour Diabetes app for Your Contour Next meter 50 Download the Contour Diabetes app 51 Pairing Mode 51 HELP Meter Care 53 Transfer Re...

Page 7: ... result is below 0 6 mmol L Your Logbook Meter Settings Symbol What the Symbol Means Fasting marker Before Meal marker After Meal marker No marker selected A Target Range or Target Range setting smartLIGHT target range indicator setting Meter is ready to test Add more blood to same test strip Control solution test result Bluetooth symbol indicates the Bluetooth wireless setting is On the meter can...

Page 8: ...om the test strip port is visible If there are missing characters or if the strip port light is a colour other than white contact Customer Service This may affect the way you see your results NOTE Your meter comes with a pre set time date and target range You can change these features in Settings See Settings on page 37 Target Ranges The meter compares your blood glucose results with a Target Rang...

Page 9: ...against the Before Meal Target Range Pre set Before Meal Target Range 3 9 mmol L 7 2 mmol L Symbol What the Symbol Means Comparison Target Range After Meal Use the After Meal marker when testing blood glucose levels within 2 hours after the first bite of a meal If you mark your result as After Meal the meter compares the result against the After Meal Target Range Pre set After Meal Target Range 3 ...

Page 10: ...e 53 Always wash your hands with antibacterial soap and water and dry them well before and after testing or handling the meter lancing device or test strips For complete instructions on cleaning your meter see page 53 Prepare the Lancing Device The lancing device graphics are for illustration purposes only Your lancing device may look different Refer to your lancing device insert for detailed inst...

Page 11: ...tective 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 Insert the Test Strip 1 Remove a Contour Next test strip from the bottle 2 Tightly close the bottle lid immediately after you have removed the test strip CAUTION Do not use expired...

Page 12: ...et the Blood Drop Fingertip Testing NOTE For Alternative Site Testing instructions see page 23 WARNING Potential Biohazard Always wash your hands with antibacterial soap and water and dry them well before and after testing or handling the meter lancing device or test strips 1 Press the lancing device firmly against the puncture site and press the release button 2 Stroke your hand and finger toward...

Page 13: ...ays an E 1 error message remove the strip and start with a new strip The meter displays your blood glucose result If Meal Markers are On the Meal Marker symbol is blinking Select a Meal Marker NOTE During a blood glucose 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 If the Meal Marker feature is O...

Page 14: ...Marker you want is blinking press the OK button 4 If this is a Before Meal reading you can set a Reminder to test your blood glucose later See the next section Set a Reminder If you do not make a Meal Marker selection within 3 minutes the meter turns off Your blood glucose reading is stored in the Logbook without a Meal Marker Set a Reminder 1 Make sure the Reminder feature is On in Settings See S...

Page 15: ...er set 10 45 22 11 18 61 If the smartLIGHT target range indicator is On the test strip port displays a colour representing your result value compared to your Before Meal After Meal or Overall Target Range If you do not select a Meal Marker your blood glucose test result is compared to an Overall Target Range Above Target Range In Target Range Below Target Range If your blood glucose result is belo...

Page 16: ... professional as soon as possible If the blood glucose reading is 13 9 mmol L or greater check your ketone levels 1 LO or HI Results 10 45 26 11 18 l0 If the meter beeps twice and displays the LO screen your blood glucose reading is under 0 6 mmol L Follow medical advice immediately Contact your health care professional 10 45 26 11 18 hi If the meter beeps once and displays the HI screen your bloo...

Page 17: ...erent from fingertip results when glucose levels are changing rapidly e g after a meal after taking insulin or during or after exercise Additionally glucose levels may not rise as high or fall as low as levels in the fingertip As such fingertip results may identify hypoglycaemic levels sooner than alternative site results Alternative Site Testing is recommended only when it is more than 2 hours af...

Page 18: ...luid mixed with the blood 8 Hold the tip of the test strip in the blood drop until the meter beeps Second Chance sampling for AST Apply More Blood 00 60 1 If the meter beeps twice and the screen displays a blinking blood drop with a plus sign the test strip does not have enough blood 2 Apply more blood to the same test strip within 60 seconds NOTE If the screen displays an E 1 error message remove...

Page 19: ...ing no food or drink for 8 hours except water or non caloric beverages Before Meal Target Range Before Meal Use the Before Meal marker when testing blood glucose levels within 1 hour before a meal After Meal Use the After Meal marker when testing blood glucose levels within 2 hours after the first bite of a meal After Meal Target Range No Mark Selected Use the No Mark symbol when testing at times ...

Page 20: ...Do not reuse lancets Used lancets are not sterile Use a new lancet each time you test Always wash your hands with antibacterial soap and water and dry them well before and after testing or handling the meter lancing device or test strips Control Solution CAUTION Use only Contour Next control solution Normal with your Contour Next blood glucose monitoring system Using anything other than Contour Ne...

Page 21: ...ttle 2 Tightly close the bottle lid immediately after you remove the test strip 3 Hold the test strip with the grey square end facing up 4 Insert the grey square end of the test strip into the test strip port until the meter beeps 10 45 26 7 18 The meter turns on displaying a test strip with a flashing blood drop NOTE If this is the first time you are opening the control solution write the date on...

Page 22: ...a problem with the test strips the meter or your testing technique If your control test result is out of range do not use your Contour Next meter for blood glucose testing until you resolve the issue Contact Customer Service See the back cover for contact information Logbook The Logbook contains blood glucose test results and Meal Markers that you have made to those test results The Logbook holds ...

Page 23: ...Averages press the button 4 To return to your Logbook readings press the button on the 7 d Avg 7 day Average 5 To exit Averages and return to the Home screen at any time press the OK button Settings In Settings you can Change the time format Change the time Change the date format Change the date Turn Sound On or Off Turn Meal Markers On or Off Turn Reminder feature On or Off View and change Target...

Page 24: ...turns on The Home screen has 2 options Logbook and Settings 10 45 26 7 18 2 To highlight the Settings symbol press the button 3 When the Settings symbol is blinking press the OK button to enter Settings 10 45 26 7 18 4 Press the OK button when the current time is blinking on the Settings screen The time format is blinking 5 To change the time format if needed press the or button then press the OK ...

Page 25: ... d or d m is blinking 5 To select Month Day Year m d or Day Month Year d m press the or button then press the OK button 26 7 18 18 6 To change the year blinking press the or button then press the OK button 26 7 18 7 7 To change the month blinking press the or button then press the OK button 26 7 18 26 8 To change the day blinking press the or button then press the OK button The meter returns to th...

Page 26: ...or a below target blood glucose reading turn the smartLIGHT feature to Off The meter returns to the Home screen Set Meal Markers 1 Press and hold the OK button until the meter turns on The Home screen has 2 options Logbook and Settings 10 45 26 7 18 2 To highlight the Settings symbol press the button 3 When the Settings symbol is blinking press the OK button to enter Settings 4 Press the button re...

Page 27: ...ess the OK button The meter returns to the Home screen Change Overall Target Range When the Meal Marker feature is Off your meter provides a pre set Overall Target Range A Target Range has a low limit and a high limit such as 3 9 mmol L 10 0 mmol L You may want your blood glucose readings to stay within a target range You can change the Overall Target Range in Settings 1 Press and hold the OK butt...

Page 28: ... until the Target symbol is blinking then press the OK button The meter displays the Low Target screen WARNING Discuss your Target Range settings with your health care professional NOTE There is only one Low target number for both the Before Meal and After Meal Target Ranges Change Low for Both Target Ranges 39 72 39 5 To change the blinking Low for both Target Ranges Before Meal After Meal press ...

Page 29: ... is blinking then press the OK button On or Off smartLIGHT Symbol 5 To turn the smartLIGHT feature On or Off press the or button to display the option you want 6 Press the OK button Set Bluetooth Wireless Functionality After pairing your meter with a mobile device the Bluetooth setting can be turned On or Off For pairing instructions see page 51 1 Press and hold the OK button until the meter turns...

Page 30: ...our Next meter is paired with the Contour Diabetes app You can set or change a Meal Marker in the meter Logbook from the app The app will always sync your most recent Target Range from the app or meter across the system The app date and time can sync to your meter You can manage your meter settings from the app like Sound or smartLIGHT target range indicator Download the Contour Diabetes app 1 On ...

Page 31: ... blue light and the Bluetooth symbol display The meter returns to the Home screen NOTE You can update your Target Ranges from the meter or from the app The most recently changed Target Ranges will update in the meter and the app when they are synced 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 m...

Page 32: ...ted CAUTION The Contour Next meter has not been tested or certified for use with any software other than the Contour Diabetes app The manufacturer is not responsible for any erroneous results from the use of other software Transfer Results to a Personal Computer You can transfer test results from the Contour Next meter to a computer where they can be summarized in a report with graphs and tables T...

Page 33: ...turn off your meter 2 Turn the meter over and slide the battery cover in the direction of the arrow 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 ...

Page 34: ...e the strip Repeat the test with a new strip E 8 Strip or Test Errors Repeat the test with a new strip If the error persists contact Customer Service Error Code What It Means What to Do Testing Errors E20 Testing Error Repeat the test with a new strip If the error persists contact Customer Service E24 Too Cold to Test Control Solution Move the meter strip and control solution to a warmer area Test...

Page 35: ...ed Technical Information Accuracy The Contour Next blood glucose monitoring system was tested with capillary blood samples from 100 subjects Two replicates were tested with each of 3 lots of Contour Next test strips for a total of 600 readings Results were compared to the YSI glucose analyzer which is traceable to the CDC hexokinase method The following accuracy results were obtained Table 1 Syste...

Page 36: ...alues from fingertip capillary blood samples obtained by 324 lay persons showed the following results 100 within 0 83 mmol L of the medical laboratory values at glucose concentrations 5 55 mmol L and 98 60 within 15 of the medical laboratory glucose concentrations 5 55 mmol L User Accuracy Radar Plot 1 7mmol L 1 9mmol L 1 1mmol L 1 4mmol L 0 8mmol L 0 6mmol L 0 3mmol L 20 0 3 3 3 0 8 16 1 2 0 0 1 ...

Page 37: ... SD mmol L Coefficient of Variation 2 23 0 06 0 058 0 068 2 8 4 36 0 07 0 067 0 079 1 7 7 63 0 11 0 102 0 121 1 5 11 80 0 18 0 170 0 202 1 6 18 94 0 24 0 223 0 264 1 3 Intermediate measurement precision which includes variability across multiple days was evaluated using control solutions at 3 glucose levels With each control solution each of 3 lots of Contour Next test strips was tested once on ea...

Page 38: ...rol Testing Temperature Range Meter Operating Humidity Range 10 RH 93 RH Test Strip Storage Conditions 0 C 30 C 10 80 Relative Humidity RH Dimensions 78 5 mm L x 56 mm W x 18 mm H Weight 53 grams Sound Output 45 dB A 85 dB A at a distance of 10 cm Radio Frequency Technology Bluetooth Low Energy Radio Frequency Band 2 4 GHz 2 483 GHz Maximum Radio Transmitter Power 1 mW Modulation Gaussian Frequenc...

Page 39: ...ange Low Control Range Normal Control Range High Shake 15 times Number of test strips included Batteries must be disposed of in accordance with laws in your country Contact your competent local authority for information on the relevant laws regarding disposal and recycling in your area The meter should be treated as contaminated and disposed of according to local safety rules It should not be disp...

Page 40: ... Accuracy of bedside glucometry in critically ill patients influence of clinical characteristics and perfusion index Mayo Clinic Proceedings 2008 83 4 400 405 5 American Diabetes Association Standards of medical care in diabetes 2016 Diabetes Care 2016 39 supplement 1 S15 6 US Food and Drug Administration Use of fingerstick devices on more than one person poses risk for transmitting bloodborne pat...

Page 41: ...sia Diabetes Care reserves the right to make changes in the design of 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 blood glucose meter when used with any test strips other than Contour Next test strips and therefore does not warrant the performance of the Cont...

Page 42: ...1 Reminder Feature 19 44 Second Chance sampling vi 16 27 Settings 19 37 38 40 41 43 44 48 49 Bluetooth wireless functionality 49 Date 40 Meal Markers 43 Reminder Feature 19 44 smartLIGHT target range indicator 48 Sound 41 Time 38 smartLIGHT target range indicator 20 48 Specifications 66 Symptoms of High or Low Blood Glucose 65 Target Ranges Before Meal After Meal Overall 7 37 45 46 47 Target Setti...

Page 43: ...let the No Coding logo Second Chance the Second Chance sampling logo Smartcolour and Smartlight are trademarks and or registered trademarks of Ascensia 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 a service mark of Apple Inc The Bluetooth word mark and logos are registered trademarks owned by Bluetooth SIG Inc...

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