Contour NEXT ONE User guide

Blood Glucose Monitoring System

INTENDED USE

The CONTOUR®NEXT ONE 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 the effectiveness of the patient’s diabetes control. The

ONTOUR NEXT ONE blood glucose monitoring

system is intended for self-testing by persons with diabetes and health care professionals in venous blood and in fresh capillary whole blood drawn from the ﬁngertip or palm. The

CONTOUR NEXT ONE blood glucose monitoring system is intended for self-testing outside the body (in vitro diagnostic use).

The

CONTOUR NEXT ONE blood glucose monitoring system should not be used for the diagnosis of or screening for diabetes or for neonatal use. Alternative site testing (palm) should be done only during steady state times (when glucose is not changing rapidly). The

ONTOUR

NEXT test strips are for use with the CONTOUR®NEXT ONE

blood glucose meter to quantitatively measure glucose in venous blood and fresh capillary whole blood drawn from the ﬁngertips or palm.

The meter is for the quantitative measurement of glucose in whole blood from 0.6 mmol/L–33.3 mmol/L.

The system is intended for in vitro diagnostic use only.

IMPORTANT SAFETY INFORMATION

WARNING

Serious Illness

The system should not be used to test critically ill patients. Capillary blood glucose testing may not be clinically appropriate for persons with reduced peripheral blood ﬂow. Shock, severe hypotension and severe dehydration are examples of clinical conditions that may adversely affect the measurement of glucose in peripheral blood.

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Talk 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 2.8 mmol/L follow medical advice immediately.

• If your blood sugar reading is over 13.9 mmol/L, or the critical level you 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

assoon 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 wellbefore and after testing or handling the meter, lancing device, or test strips.

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• All blood glucose measuring systems are considered biohazardous. Health care professionals or persons using this system on multiple patients should follow the infection control procedure approved by their facility. All products or objects which come in contact with human blood, even after cleaning, should be handled as if capable of transmitting infectious diseases. The user should follow the recommendations for prevention of blood-borne transmissible diseases in health care settings as recommended for potentially infectious human specimens.

• The lancing device provided is intended for self-testing by a single patient. It must not be used on more than one person due to the risk of infection.

• Always dispose of used test strips and lancets as medical waste or as advised by your health care professional.

• All products that come in contact with human blood should be handled as if capable of transmitting infectious diseases.

• Keep out of reach of children. This kit contains small parts that could cause suffocation if accidentally swallowed.

• Keep batteries away from children. Many types of batteries are poisonous. If swallowed, immediately contact your poison control centre.

PRECAUTIONS

•

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.

• 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

ONTOUR NEXT test strips and CONTOUR

NEXT control solution.

• Always keep the C

ONTOUR 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. This could lead to inaccurate results. Do not use a test strip that appears damaged or has been used.

• Do not use expired materials. Using expired material can cause inaccurate results. Always check the expiration dates on your test 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 the date you ﬁrst opened the bottle.

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• If your control solution test result is out of range, contact Diabetes Care Customer Service. See the back cover for 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 5°C and 45°C. If meter or test strip is outside this range, you should not test until the meter and test strip are within this range. Whenever the meter is moved from one location to another, allow approximately 20 minutes for the meter to adjust to the temperature of the new location before performing a blood glucose test.

• Do not attempt to perform a blood glucose test when the

ONTOUR NEXT ONE meter is connected to a computer.

• Use only approved equipment from the manufacturer or certiﬁed body such as UL, CSA, TUV, or CE.

• Avoid use of electronic devices in very dry environments, especially if synthetic materials are present.

• Your

CONTOUR NEXT ONE meter has been preset and locked to display results in mmol/L (millimoles of glucose per litre of blood).

v Results in mmol/L will always have a decimal point. v Results in mg/dL will never have a decimal point.

Example:

v Check your display screen to be sure the results are shown

correctly. If not, contact Diabetes Care Customer Service. See the back cover 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. Wash your hands or the test site. Repeat the test with a new strip. If results are still over

33.3 mmol/L, follow medical advice immediately.

Your Meter Features

Easy: The CONTOUR NEXT ONE blood glucose monitoring system is about simplicity. You will notice this the ﬁrst time you use it.

Automatic: The C

ONTOUR NEXT ONE meter is designed with

NoCoding technology, to automatically code itself every time you insert a test strip. It will also automatically mark a control solution test.

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.

CAUTION: Your CONTOUR NEXT ONE meter works ONLY with C

ONTOUR NEXT test strips and CONTOUR NEXT control solution.

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Ascensia, the Ascensia Diabetes Care logo, Contour, Glucofacts, and Second-Chance 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., 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.

= 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.

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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 to Test .......................................................................12

Get the Blood Drop: Fingertip Testing ........................................17

Select a Meal Marker .................................................................19

About Meal Markers ...................................................................23

Turn Meal Markers On ................................................................23

Test Results ................................................................................24

Expected Test Result Values ......................................................24

LO or HI Results .........................................................................25

Alternative Site Testing (AST): Palm ...........................................25

Control Solution Testing .............................................................33

FEATURES

Logbook .....................................................................................36

Settings ......................................................................................37

Pairing Mode ..............................................................................46

HELP

Meter Care .................................................................................46

Transfer Results to the CONTOUR DIABETES App .......................47

Transfer Results to a Personal Computer ..................................48

Batteries .....................................................................................48

TECHNICAL INFORMATION

Error Detection Displays.............................................................51

Customer Service Checklist .......................................................53

Technical Information .................................................................54

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GETTING STARTED

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Symptoms of High or Low Blood Glucose.................................58

Speciﬁcations .............................................................................60

Warranty .....................................................................................64

Index ..........................................................................................66

Your CONTOUR NEXT ONE Meter

Test Strip Port

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 to

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 and return to

Home, press the OK button. NOTE: The meter screen dims after 30 seconds of inactivity.

Press any button to bring up the screen.

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GETTING STARTEDGETTING STARTED

CONTOUR®NEXT ONE blood glucose monitoring system

Your CONTOUR NEXT ONE Meter Screen

Test Strip Port

Time

Test Result in Target

Meal Marker

Date

Symbol What the Symbol Means

Blood sugar test result is in Target Range.

Blood sugar test result is above 33.3 mmol/L.

Blood sugar test result is below 0.6 mmol/L.

Blood sugar test result is above Target Range.

Blood sugar test result is below Target Range.

Logbook entr y.

Meter Settings.

Fasting m arker.

Before Meal mar ker.

After Meal m arker.

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.

Indicates low batteries.

Indicates dead batteries.

Indicates a meter error.

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GETTING STARTED

CONTOUR®NEXT ONE blood glucose monitoring system

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. o Note changes in medication. o Add photos of your meal. o Log an increase or decrease in activity.

• Set testing reminders.

• Access easy-to-read graphs of test results over a day or over a

period of time.

• Share reports.

• Discreetly view information.

• Review your Fasting, Before 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 smartphone or tablet, go to the App StoreSM or the Google Play

™

store.

2. Search for the CONTOUR DIABETES app.

3. Install the CONTOUR DIABETES app.

Scan with QR Code App or visit

www.contourone.com to

learn more.

Initial Setup from the CONTOUR DIABETES App

The easiest way to set up your new meter is to download the

ONTOUR DIABETES app to your smartphone or tablet and follow the

instructions in the app. If you do not pair your meter with the C

ONTOUR DIABETES app, follow

the instructions in Initial Setup from the Meter the ﬁrst time you turnon your meter.

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GETTING STARTED

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Initial Setup from the Meter

OK Button

Press and hold the OK button for 2 seconds until the meter turns on.

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.

If there are missing characters or if the strip port light is a colour other than white, contact Diabetes Care Customer Service. 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 on the outer ring.

Outer Ring

2. To set the hour and move to minutes, press the OK button.

3. To change the minutes, press the

or button on the outer ring, then press the OK button. Continue to Set the Date.

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GETTING STARTED

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Set the Date

The year is blinking.

1. To change the year, press the

or button, then press the

OK button.

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.

Target Ranges and Meal Markers

The meter compares your blood sugar results with a Target Range (for example, 3.9 mmol/L–7.2 mmol/L) to let you know if your test result is:

• within

your Target Range.

• above

your Target Range.

• below

your Target Range.

Within Your Target Range.

Above Your Target Range.

Below Your Target Range.

You can attach a Meal Marker to 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 Before Meal Target Range.

• If you mark your result as After Meal, the meter compares the result against the After Meal Target Range.

• If you do not mark the result, the meter compares your test result against the Overall Target Range.

Symbol Target Range

Pre-set Fasting Target Range: 3.9 mmol/L – 7.2 mmol/L

Pre-set Before Meal Target Range: 3.9 mmol/L–7.2 mmol/L

Pre-set After Meal Target Range: 3.9 mmol/L–10.0 mmol/L

Pre-set Overall Target Range: 3.9 mmol/L – 10.0 mmol/L

Your CONTOUR NEXT ONE meter comes with Meal Markers turned Off.

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TESTING

CONTOUR®NEXT ONE blood glucose monitoring system

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

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.

CAUTION: Your

CONTOUR NEXT ONE meter works only with

CONTOUR NEXT test strips and CONTOUR NEXT control solution.

Fingertip Testing

Ensure that you have the materials you need before you begin testing:

• C

ONTOUR 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 C

ONTOUR NEXT

control solution. Some supplies are available 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 handling the meter, lancing device, or test strips.

• For complete instructions on cleaning your meter, see page 47.

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 instructions on preparing the lancing device.

WARNING: Potential Biohazard

• The lancing device provided is intended for self-testing by a single patient. It must not be used on more than one person due to the risk of infection.

•

Do not reuse lancets. Used lancets are not sterile. Use a

new lancet each time you test.

WARNING: Potential Biohazard

Always dispose of used test strips and lancets as medical waste or as advised by your health care professional.

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TESTING

CONTOUR®NEXT ONE blood glucose monitoring system

1. Remove the endcap from the lancing device.

2. Loosen the round protective cap

on a lancet by rotating the cap ¼turn, but do not remove 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.

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Insert the Test Strip

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. Insert the grey square end ﬁrmly into the test strip port until the meter beeps.

The screen displays the blinking

blood drop 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 your hand and ﬁnger toward the puncture site to form a drop of blood.

Do not squeeze around the puncture site.

3. Test immediately after you have formed a small, round blood drop, as shown.

4. Immediately touch the tip of the test strip to the drop of blood.

The blood is drawn into the test strip through the tip.

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Select a Meal Marker

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.

If the Meal Marker feature is On, a Fasting

, Before Meal ,

After Meal

, or No Mark marker is blinking on the blood sugar result screen. The meter suggests this Meal Marker based on the time of day and the meal period: fasting/breakfast, lunch, dinner, or overnight. Example:

OK Button

Do not press the OK button yet.

You can select the blinking marker or choose a different Meal Marker.

OK Button

1. If the blinking Meal Marker is the one you want, press the OK button

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, do not remove the test strip until you select a Meal Marker.

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 test strip within 60 seconds.

3. If the screen displays an E 1 error message, remove the strip and start with a new strip.

The meter displays your blood sugar result. If the Meal Markers are On, the Meal Marker symbol is blinking.

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What the Symbol Means

OK Button

3. When the Meal Marker you want is blinking, press the OK button.

If you do not make a Meal Marker selection within 30 seconds, the screen dims. Press any button to turn the screen back on and make your selection.

If you do not make a Meal Marker selection within 3 minutes, the meter turns off. Your blood sugar reading is stored in the Logbook without a Meal Marker.

Blood Sugar Test is Complete

When your blood sugar test is complete, the meter displays your result with the units, time, date, meal marker (if selected), and target indicator: In Target

, Below Target , or Above Target .

Example: Blood test result with Meal Marker selected:

NOTE: To change a Meal Marker you selected, you must use the

ONTOUR DIABETES app.

Example: Blood test result with Meal Markers Off or marker not selected:

Meal Marker choices if Meal Marker feature is On

Symbol

Fasting: Use the Fasting

marker when testing blood sugar levels after fasting (no food or drink for 8 hours, except water or non-caloriﬁc beverages).

Fasting Target Range

Before Meal: Use the Before Meal marker when

testing blood sugar levels within 1 hour before a meal.

Before Meal Target Range

After Meal: Use the After Meal marker when

testing blood sugar 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 other than after fasting or before or af ter a meal.

Overall Target Range

Example: If you scroll up to Fasting, the Fasting marker blinks.

Example: If you scroll down to After Meal, the After Meal marker blinks.

Related Target Range

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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.

Your

ONTOUR NEXT ONE meter comes with Meal Markers turned

Off. You can turn Meal Markers On in Settings.

Turn Meal Markers On

To turn

Meal Markers On

see

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 Light (smartLIGHT) is red and meter beeps twice.

If you do not select a Meal Marker, your blood sugar test result is compared to an Overall Target Range.

OK Button

4. To move to the Home screen, press the OK button

5. To turn the meter off, remove the test strip.

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LO or HI Results

• If the meter beeps twice and displays the LO screen, your blood sugar reading is under

0.6 mmol/L. Follow medical advice immediately. Contact your health care professional.

• If the meter beeps once and displays the HI screen, your blood sugar reading is over 33.3 mmol/L.

1. Wash and dry your hands well.

2. Retest with a new strip.

If results are still over 33.3 mmol/L, follow medical advice immediately.

Alternative Site Testing (AST): Palm

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.

• Do not calculate an insulin dose based on an AST result.

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.

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 well.

2. Retest with a new strip.

If you get a similar result, call your health care professional as soon as possible.

Expected Test Result Values

Blood sugar values will vary depending on food intake, medication dosages, health, stress, or activity. Nondiabetic plasma glucose concentrations should be less than 5.6 mmol/L in the fasting state and less than 7.7 mmol/L in the post-prandial state (after a meal).

You should consult with your health care professional for glucose values speciﬁc to your needs.

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Get a Blood Drop: Alternative Site Testing

1. Wash your hands and the puncture site with soap and warm water.

Rinse and dry well.

2. Attach the clear AST endcap to the lancing device, if provided with your kit.

Refer to the lancing device insert for detailed instructions.

3. Select a puncture site from a

ﬂeshy area on the palm. Avoid veins, moles, bones, and tendons.

The lancing device graphics are for illustration purposes only.

4. Press the lancing device ﬁrmly

against puncture site, then press the release button.

5. Maintain steady pressure until a small, round blood drop forms.

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 (hypoglycaemic 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.

Alternative site results may be different 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 after a meal, diabetes medication, or exercise.

If you do not have a clear lancing device endcap to perform AST, contact Diabetes Care Customer Service. See the back cover for contact information.

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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.

Do not test the blood sample from palm if you get:

• Smeared blood.

• Clotted blood.

• Runny blood.

• Clear ﬂuid mixed with the blood.

8. Hold the tip of the test strip in the blood drop until the meter beeps.

CAUTION: Do not press the test strip tip against the skin or place

the blood on top of the test strip. These actions could lead to inaccurate results or errors.

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.

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 marker for your blood sugar result. This is based on the time of day and the meal period: fasting/breakfast, lunch, dinner or overnight. The Meal Marker is blinking.

OK Button

Do not press the OK button yet.

You can select the blinking marker or choose a different Meal Marker.

OK Button

4. If the blinking Meal Marker is the one you want, press the OK button

Outer Ring

5. To select another Meal Marker, press the

or button on the outer ring to scroll between markers.

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TESTING

CONTOUR®NEXT ONE blood glucose monitoring system

Meal Marker choices if the 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-caloriﬁc beverages).

Fasting Target Range

Before Meal: Use the Before Meal marker when

testing blood sugar levels within 1 hour before a meal.

Before Meal Target Range

After Meal: Use the After Meal marker when

testing blood sugar 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 other than after fasting or before or after a meal.

Overall Target Range

6. When the Meal Marker you want is blinking, press the OK button.

For more information about Meal Markers, see Select 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 usually 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 test strips are for singlepatient use. Do not share them with anyone including other family members. Do not use on multiple patients.

5,6

• All products that come in contact with human blood should be handled as if capable of transmitting infectious diseases.

• Always dispose of used test strips and lancets as medical waste or as advised by your health care professional.

•

Do not reuse lancets. Used lancets are not sterile. Use a

new lancet each time you test.

• 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.

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TESTING

CONTOUR®NEXT ONE blood glucose monitoring system

Control Solution

WARNING

• Shake the control solution well before testing.

CAUTION: Use only CONTOUR NEXT control

solution (Normal, Low, and High) with your

CONTOUR NEXT ONE blood glucose

monitoring system. Using anything other than

ONTOUR 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.

You should perform a control test when:

• Using your meter for the ﬁrst time.

• You open a new bottle or package of test strips.

• You think your meter may not be working properly.

• You have repeated, unexpected blood sugar results.

WARNING

• Do not calibrate your continuous 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.

Control solution is available separately if not included in the meter kit. You can test your C

ONTOUR NEXT ONE meter with control solution

when the temperature is 15°C–35°C. Always use C

ONTOUR NEXT control solutions. Other brands could yield

incorrect results. If you need help locating C

ONTOUR NEXT control

solutions, contact Diabetes Care Customer Service or order online. See the back cover for contact information.

Control Solution Testing

1. Remove a CONTOUR NEXT test strip from the bottle.

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.

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TESTING

CONTOUR®NEXT ONE blood glucose monitoring system

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.

NOTE: If this is the ﬁrst time you are opening the control solution, write the date on the bottle.

5. Shake the control solution bottle well, about

15 times before every use.

6. Remove the bottle cap and use a tissue to wipe away any solution around the bottle tip before dispensing a drop.

7. Squeeze a small drop of solution onto a clean, nonabsorbent surface.

CAUTION: Do not apply control solution to your ﬁngertip or to the

test strip directly from the bottle.

8. Immediately touch the tip of the test 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

ONTOUR DIABETES app.

10. Compare your control test result with the range printed on the test strip bottle or on the bottom of the test strip box.

11. Remove the test strip and dispose as medical waste or as advised by your health care professional.

If your result does not fall within the range listed on the test strip bottle label or carton, there may be 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

ONTOUR NEXT ONE meter for blood sugar testing until you resolve

the issue. Contact Diabetes Care Customer Service. See the back cover for contact information.

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FEATURES

CONTOUR®NEXT ONE blood glucose monitoring system

Logbook

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.

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. Press and hold the OK button until the meter turns on, about 2 seconds.

The Logbook

is blinking.

2. To select the blinking Logbook symbol, press the OK button.

3. To view your individual test results, press the

button.

4. To scroll through your test results, press the

or button.

To scroll 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 the date.

• Turn Sound On or Off.

• Turn Meal Markers On or Off.

• View Target Ranges.

• Turn Target Lights (smartLIGHT) On or Off.

• Turn Bluetooth On or Off. You must accept or change each setting with the OK button before

moving to the next one.

Access Settings

1. Press and hold the OK button 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 the OK button to enter Settings.

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FEATURES

CONTOUR®NEXT ONE blood glucose monitoring system

4. Continue to press the OK button until you see the Date Format screen.

Date Format

The date format (m/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.

6. To change the year (blinking), press the

or button, then

press the OK button.

7. To change the month (blinking), press the

or button, then

press the OK button.

8. To change the day (blinking), press the

or button, then press the

OK button.

The meter displays the Sound 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.

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.

Change the Date

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.

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FEATURES

CONTOUR®NEXT ONE blood glucose monitoring system

Set the Sound

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. Continue to press the OK button until you see the Sound screen.

Sound Symbol:

Your meter comes with the Sound turned On. Certain error messages override any Sound setting.

When Sound is On:

• One long beep indicates a conﬁrmation.

• Two beeps indicate an error or something that needs your attention.

5. To turn the Sound On or Off, press the

or button to display

the option you 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 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 Meal Marker screen.

Meal Marker Symbols:

Your meter comes with Meal Marker feature turned OFF.

5. To turn Meal Markers On or Off, press the

or button to

display the option you want.

6. Press the OK button.

NOTE: When the Meal Marker feature is On, you can select a Meal Marker during a blood sugar test.

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FEATURES

CONTOUR®NEXT ONE blood glucose monitoring system

View Target Ranges

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.

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. Continue to press the OK button until you see the Fasting Target Range screen below.

5. To 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 displays the Overall Target Range.

You can change this range only in the

CONTOUR DIABETES app.

9. To move to the next screen, press the OK button.

The meter displays the Target Lights screen.

Set Target Lights (smartLIGHT)

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 colour that corresponds to your test result.

In Target Below Target Above Target

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FEATURES

CONTOUR®NEXT ONE blood glucose monitoring system

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. Continue to press the OK button until you see the Target Lights screen.

Target Light Symbol:

5. To turn Target Lights On or Off, press the or button to display the option you want.

6. Press the OK button.

Set 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. Continue to press the OK button until you see the Bluetooth screen.

Bluetooth Symbol:

5. To turn Bluetooth On or Off, press the or button to display the option you want.

6. Press the OK button. The meter brieﬂy displays your saved settings, then beeps and returns to the Home screen.

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HELP

CONTOUR®NEXT ONE blood glucose monitoring system

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.

Example: Your meter in pairing mode:

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.

• Handle the meter carefully to avoid damaging the electronics or causing other malfunctions.

• Avoid exposing your meter and test strips to excessive humidity, heat, cold, dust, or dirt.

1. Clean the exterior of the meter using a moist (not wet) lint-free tissue with a mild detergent or disinfect using a disinfectant solution, such as 1 part bleach mixed with 9 parts water.

2. Wipe dry with lint-free tissue after cleaning.

3. Do not insert anything into the test strip port or attempt to clean

inside the test strip port.

CAUTION: Do not allow cleaning solution to run into the meter through open areas, such as around the buttons or the meter’s test strip or data ports, such as the USB port.

Transfer Results to the CONTOUR DIABETES App

CAUTION: The CONTOUR NEXT ONE 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.

You can automatically transfer results from your CONTOUR NEXT ONE meter wirelessly to your smartphone or tablet. See Download the

ONTOUR DIABETES App on page 7 and follow the app instructions

to pair your meter and get started.

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HELP

CONTOUR®NEXT ONE blood glucose monitoring system

Transfer Results to a Personal Computer

CAUTION: Do not attempt to perform a blood glucose test when the CONTOUR NEXT ONE meter is connected to a computer.

You can transfer test results from the CONTOUR NEXT ONE meter to a computer where they can be summarized in a report with graphs and tables. To make use of this feature, you need

GLUCOFACTS®DELUXE diabetes management 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 the batteries immediately. When you see this symbol, you can only test about 10 more times over the next 3 days before the batteries are dead.

The meter operates normally, displaying the Low Batteries symbol until you replace the batteries.

When you are no longer able to perform a test due to low batteries, the meter displays the Dead Batteries screen. Replace the batteries immediately.

Replace the Batteries

1. Before replacing your batteries, turn off your meter.

2. Turn the meter over and slide the back cover in the direction of the arrow.

The battery holder comes out.

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. Hold the battery holder so that the round end is on the right.

6. Insert the edge of one battery into the left side of the compartment and press down on the right side.

7. Press the other battery into the left compartment.

8. Slide the battery holder back into place.

9. Discard batteries according to your local environmental regulations.

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TECHNICAL INFORMATION

CONTOUR®NEXT ONE blood glucose monitoring system

WARNING

Keep batteries away from children. Many types of batteries are poisonous. If swallowed, immediately contact your poison control centre.

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 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 strip. Repeat the test with a new strip.

E 2 Used Test Strip

Remove the strip. Repeat the test with a new strip.

E 3 Strip Upside Down

Remove the strip and insert it correctly.

E 4 Wrong Strip Inserted

Remove the strip. Repeat the test with a

CONTOUR NEXT

test strip.

E 6 Moisture Damaged Strip

Remove 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.

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 in 20 minutes.

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TECHNICAL INFORMATION

CONTOUR®NEXT ONE blood glucose monitoring system

Error Code What it Means What to Do

E25

Too Hot to Test Control Solution

Move the meter, strip, and control solution to a cooler area. Test in 20 minutes.

E27 Too Cold to Test

Move the meter and strip to a warmer area. Test in 20minutes.

E28 Too Hot to Test

Move the meter and strip to a cooler area. Test in 20minutes.

System Errors

E30–E99

Meter software or hardware malfunctioned

Turn the meter off. Turn the meter back on. If the error persists, contact Customer Service.

Speak to a Customer Service representative before returning your meter for any reason. Contact Diabetes Care Customer Service. Seethe back cover for contact information.

Customer Service Checklist

When speaking with the Diabetes Care Customer Service representative:

1. Have your

ONTOUR NEXT ONE blood

glucose meter, CONTOUR NEXT test strips, and C

ONTOUR 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 Information

To replace missing parts or reorder supplies, contact Diabetes Care Customer Service. See the back cover for contact information.

• CONTOUR NEXT ONE User Guide.

• CONTOUR NEXT Normal Control Solution.

• Lancing device, as in your kit, if provided.

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TECHNICAL INFORMATION

CONTOUR®NEXT ONE blood glucose monitoring system

Technical Information: Accuracy

The CONTOUR NEXT ONE blood glucose monitoring system was tested with capillary blood samples from 100 subjects. Two replicates were tested with each of 3 lots of

ONTOUR 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: System accuracy results for glucose concentration < 5.55 mmol/L

Difference range in values

between YSI laboratory

reference method and

CONTOUR NEXT ONE meter

Within

± 0.28

mmol/L

Within ± 0.56

mmol/L

Within

± 0.83

mmol/L

Number (and percent) of samples

within speciﬁed range

191 of 210

(91.0%)

210 of 210

(100%)

210 of 210

(100%)

Table 2: System accuracy results for glucose concentration ≥ 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 ISO 15197:2013 is that 95% of the measured glucose values shall fall within either ± 0.83 mmol/L of the average measured values of the reference measurement procedure at glucose concentrations < 5.55 mmol/L or within ± 15% at glucose concentrations ≥ 5.55 mmol/L.

User Accuracy

A study evaluating glucose values from ﬁngertip capillary blood samples obtained by 329 lay persons showed the following results:

98.6% within ± 0.83 mmol/L of the medical laboratory values at glucose concentrations below 5.55 mmol/L and 99.6% within ± 15% of the medical laboratory glucose concentrations at or above

5.55 mmol/L.

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TECHNICAL INFORMATION

CONTOUR®NEXT ONE blood glucose monitoring system

User Accuracy Radar Plot

1.7

mmol/L

1.4

mmol/L

>1.9

mmol/L

10% 25% 30% >35%20%15%

1.1

mmol/L

0.8

mmol/L

0.6

mmol/L

0.3

mmol/L

1.7

mmol/L

>1.9

mmol/L

10%

25%3%

>35520%%155

l/L

0.8

l/L

m0.m

0.3

l/L

(

)

–

All samples (n = 329)

15-15 Zone (0.8 mmol/L or 15%)

0.6 mmol/L or 10%

The 329 data points represent the blood glucose monitoring system (BGMS) results. The distance from the centre represents the magnitude of the error compared with the laboratory reference result.

If a data point is at the centre, there is zero error, which means the BGMS reading is identical 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

ONTOUR NEXT ONE blood glucose monitoring system using

5venous whole blood specimens with glucose levels from

2.4 mmol/L to 18.5 mmol/L. With each blood specimen, each of 3lots of

CONTOUR NEXT test strips was tested 10 times on each of 10instruments for a total of 300 readings. The following precision results were obtained.

Table 1: System repeatability results for

CONTOUR NEXT ONE

meter using CONTOUR NEXT test strips

Mean,

mmol/L

Pooled

Standard

Deviation,

mmol/L

95% CI of

SD, mmol/L

Coefﬁcient of

Variation, %

2.43 0.05 0.046 –0.055 2.1

4.31 0.07 0.063–0.075 1.6

7.17 0.10 0.090–0.106 1. 4

11. 39 0.16 0.147 –0.1 74 1.4

18. 41 0.22 0.201–0.238 1.2

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TECHNICAL INFORMATION

CONTOUR®NEXT ONE blood glucose monitoring system

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

ONTOUR NEXT

test strips was tested once on each of 10 instruments on 10 separate days for a total of 300 readings. The following precision results were obtained.

Table 2: System intermediate precision results for

ONTOUR NEXT ONE meter using CONTOUR NEXT test strips

Control

Level

Mean,

mmol/L

Pooled

Standard

Deviation,

mmol/L

95% CI of

SD, mmol/L

Coefﬁcient

Variation, %

Low 2.33 0.03 0.030–0.036 1.4

Normal 6.86 0.08 0.076–0.091 1.2

High 20.1 5 0.30 0.276–0.327 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. According to the American Diabetes Association (www.diabetes.org), some of the most common symptoms are:

Low blood glucose (Hypoglycaemia):

• shakiness

• sweating

• fast heartbeat

• blurred vision

• confusion

• passing out

• seizure

• irritability

• extreme hunger

• dizziness

High blood glucose (Hyperglycaemia):

• 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, test your blood glucose. If your test result is under 2.8 mmol/L or above 13.9 mmol/L, contact your health care professional immediately.

For additional information and a complete list of symptoms, contact your health care professional.

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TECHNICAL INFORMATION

CONTOUR®NEXT ONE blood glucose monitoring system

Symbols Used

The following symbols are used throughout the product labeling for the CONTOUR NEXT ONE blood glucose monitoring system (meter packaging and labeling, and reagent and control solution packaging and labeling).

Symbol What it Means

Use by date (last day of month)

Warning, improper use could result in injury or illness.

Do not reuse

Sterilized using irradiation

Batch Code

Control Discard Date

Temperature limitations

Consult instructions for use

In Vitro Diagnostic Medical Device

Manufacturer

Catalogue number

Control Range Low

Control Range Normal

Control Range High

Shake 15 times

Speciﬁcations

Test Sample: Capillary and venous whole blood Test Result: Referenced to plasma/serum glucose Sample Volume: 0.6 μL Measuring Range: 0.6 mmol/L–33.3 mmol/L of glucose in blood Countdown Time: 5 seconds Memory: Stores most recent 800 test results Battery Type: Two 3-volt CR2032 or DL2032 coin cell batteries,

225mAh capacity Battery Life: Approximately 1000 tests (1 yr. average use, 3 tests

per day)

Meter Operating Temperature Range:

Control Testing Temperature Range: Meter Operating Humidity Range: 10%–93% RH Dimensions: 97 mm (L) x 28 mm (W) x 14.9 mm (H) Weight: 36 grams Meter Life: 5 years Sound Output: 45 dB(A)–85 dB(A) at a distance of 10 cm Electromagnetic Compatibility (EMC): The

ONTOUR NEXT ONE meter

complies with the electromagnetic requirements speciﬁed in ISO 15197: 2013. 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

ONTOUR NEXT ONE meter. The CONTOUR NEXT ONE meter meets the

requirements of IEC 61000-4-2 for immunity to electrostatic 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 with the proper operation of the meter.

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TECHNICAL INFORMATION

CONTOUR®NEXT ONE blood glucose monitoring system

Symbol What it Means

Recycle Packaging

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 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 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.

Comparison Options: The

CONTOUR NEXT ONE system is designed for use with capillary whole blood. Comparison with a laboratory method must be done simultaneously with aliquots of the same sample.

NOTE: Glucose concentrations drop rapidly due to glycolysis (approximately 5%–7% per hour).

References

1. Wickham NWR, et al. Unreliability of capillary blood glucose in peripheral vascular disease. Practical Diabetes. 1986;3(2):100.

2. Atkin SH, et al. Fingerstick glucose determination in shock. Annals of Internal Medicine. 1991;114(12):1020-1024.

3. Desachy A, et al. Accuracy of bedside glucometry in critically ill patients: inﬂuence of clinical characteristics and perfusion index. Mayo Clinic Proceedings. 2008;83(4):400-405.

4. American Diabetes Association. Standards of medical care in diabetes—2014. Diabetes Care. 2014;37(supplement 1):S14.

5. US Food and Drug Administration. Use of ﬁngerstick 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://www.fda.gov/ MedicalDevices/Safety/AlertsandNotices/ucm224025.htm

6. 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/ Fingerstick-DevicesBGM.html

7. Burtis CA, Ashwood ER, editors. Tietz Fundamentals of Clinical Chemistry. 5th edition. Philadelphia, PA: WB Saunders Co;

2001;444.

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TECHNICAL INFORMATION

CONTOUR®NEXT ONE blood glucose monitoring system

Warranty

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). During the stated 5-year period, Ascensia Diabetes Care shall, at no charge, replace a unit found to be defective with an equivalent or current version of the owner’s model.

Limitations of Warranty: This warranty is subject to the following exceptions and limitations:

1. A 90-day warranty only will be extended for consumable parts and/or accessories.

2. This warranty is limited to replacement due to defects in parts or workmanship. Ascensia Diabetes Care shall not be required to replace any units that malfunction or are damaged due to abuse, accidents, alteration, misuse, neglect, maintenance by someone other than Ascensia Diabetes Care, or failure to operate the instrument in accordance with instructions. Further, Ascensia Diabetes Care assumes no liability for malfunction of or damage to Ascensia Diabetes Care instruments caused by the use of test strips or control solution other than the appropriate products recommended by Ascensia Diabetes Care (i.e.,

ONTOUR NEXT test

strips and CONTOUR NEXT control solutions).

3. Ascensia 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 ONE blood glucose meter when used with any

test strips other than C

ONTOUR NEXT test strips, and therefore does

not warrant the performance of the C

ONTOUR NEXT ONE meter

when used with any test strips other than CONTOUR NEXT test strips or when the C

ONTOUR NEXT test strip is altered or modiﬁed in

any manner.

5. Ascensia Diabetes Care makes no warranty regarding the performance of the

CONTOUR NEXT ONE meter or test results when

used with any control solution other than C

ONTOUR NEXT control

solution.

6. Ascensia Diabetes Care makes no warranty regarding the performance of the

ONTOUR NEXT ONE meter or test results when

used with any software other than the C

ONTOUR DIABETES

app

(where supported) or the G

LUCOFACTS DELUXE diabetes

management software (where supported) from ASCENSIA DIABETES CARE.

ASCENSIA DIABETES CARE MAKES NO OTHER EXPRESS WARRANTY FOR THIS PRODUCT. THE OPTION OF REPLACEMENT, DESCRIBED ABOVE, IS THE ONLY OBLIGATION OF ASCENSIA DIABETES CARE UNDER THIS WARRANTY.

IN NO EVENT SHALL ASCENSIA DIABETES CARE BE LIABLE FOR INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES, EVEN IF ASCENSIA DIABETES CARE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

For warranty service: Purchaser must contact Ascensia Diabetes Care Customer Service for assistance and/or instructions for obtaining service of this instrument. See the back cover for contact information.

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CONTOUR®NEXT ONE blood glucose monitoring system

Index

After Meal Marker ....................................................... 4, 19, 20, 29, 30

Alternative Site Testing (AST) ........................................................... 25

Batteries ................................................................................. 5, 48, 53

Low Batteries ........................................................................ 5, 48

Replacement ....................................................................... 49, 53

Before Meal Marker .................................................... 4, 19, 20, 29, 30

ONTOUR DIABETES App for Your ONE Meter .................................... 6

Control Solution Testing ................................................................... 33

Customer Service Checklist ............................................................. 53

Error Detection Displays ................................................................... 51

GLUCOFACTS DELUXE diabetes management software .............. 48, 65

Initial Setup from the C

ONTOUR DIABETES App .................................. 7

Initial Setup from the Meter ................................................................ 8

Lancing Instruction ........................................................................... 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 ................................................................................... 60

Symptoms of High or Low Blood Glucose ....................................... 58

Target Ranges (Before Meal, After Meal, Overall) ............................. 42

Target Settings.............................................................................. 8, 42

Technical Information ....................................................................... 51

Testing Your Blood Sugar ................................................................. 12

After Meal .......................................................... 11, 19, 20, 29, 30

Before Meal ....................................................... 11, 19, 20, 29, 30

Get Ready to Test ...................................................................... 12

Select a Meal Marker ................................................................ 19

Test Results ............................................................................... 24

Transfer Results to a Personal Computer ................................. 48

Transfer Results to the

CONTOUR DIABETES App ...................... 47

Turn Meal Markers On ...................................................................... 23

Warranty ........................................................................................... 64

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Ascensia Diabetes Care Ireland Ltd PO Box 12721 Dublin 24 Ireland

Ascensia Diabetes Support Group 1 890 920 111 – Ireland www.contourone.com

Ascensia Diabetes Care UK Ltd Ascensia House Albert Road Newbury, Berkshire RG14 1DL UK

Ascensia Diabetes Support Group 0345 600 6030 – UK www.contourone.com

Order supplies: www.diabetes.ascensia.co.uk (UK) or www.diabetes.ascencia.ie (IE).

For more information, go to www.contourone.com or call Diabetes Care Customer Service: 0345 600 6030 (UK) or 1 890 920 111 (IE) (available Monday – Friday, 9am – 5pm).

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 NEXT ONE meters

and CONTOUR NEXT 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, and Second-Chance 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., 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.

Ascensia Diabetes Care Holdings AG

Peter Merian-Strasse 90

4052 Basel, Switzerland

Allrights reserved.

84726605 Rev. 04/16

Contour NEXT ONE User guide

Specifications and Main Features

Frequently Asked Questions

User Manual