Ascensia Diabetes Care US O5 Contour Next One Blood Glucose Monitoring System User Manual Manual

Ascensia Diabetes Care US Inc. Contour Next One Blood Glucose Monitoring System Manual

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PROCESS YPROCESS MPROCESS C PROCESS K

FILE NAME: 85025015_CntrNxtONE_UG_EN.indd NEW COMP BAN: 85025015

REV: 08/16

DESCRIPTION: Onyx Contour NEXT ONE Meter User Guide

DATE: 08/18/16 CLIENT: Ascensia Diabetes Care V0 09/23/15 Initial build

V1 10/19/15 DMC Annotation

V2 10/24/15 DMC Annotation

V3 11/11/15 DMC Annotation

V4 04/19/16 DMC Annotation

V5 05/02/16 DMC Annotation

V6 08/11/16 DMC Annotation

V7 08/18/16 DMC Annotation

PROGRAM VERS: InDesign CC(2014) SKU: MULTI

5050 1st Ave South

Suite #101

Seattle, WA 98134

Tel: 206.587.0800

Fax: 206.587.0356

MARKET: US SPEC: 10000774658 REV 01

LANGUAGES: EN PARENT BAN: MULTI BAR CODE: 85025015 (2D)

TRIM SIZE: 6” (H) x 4.5” (W) PREVIOUS BAN: N/A

UNIT of MEASURE: mg/dL MASTER REF: DCAM-69-1823 version 5.0

LASER PROOF EPSONS PROOF SIGNATURE

APPROVED

RESUBMIT WITH CHANGES

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RESUBMIT WITH CHANGES

PROJ. MGR. SIGNATURE _________________________________ DATE ____________

VERSION: V7

USER GUIDE

Uses only CONTOUR®NEXT blood glucose test strips.

Blood Glucose

Monitoring System

Works with the CONTOUR™DIABETES app available for download

on the App Store® or on Google Play™.

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INTENDED USE

The CONTOUR®NEXT ONE blood glucose monitoring system is

intended to be used for the quantitative measurement of glucose in

fresh capillary whole blood drawn from the ﬁngertips or palm. The

CONTOUR NEXT ONE blood glucose monitoring system is intended

to be used by a single person and should not be shared. The

CONTOUR NEXT ONE blood glucose monitoring system is intended

for self-testing outside the body (in vitro diagnostic use) by people

with diabetes at home as an aid in monitoring the effectiveness of a

diabetes control program.

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

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

blood glucose meter to quantitatively measure glucose in fresh

capillary whole blood drawn from the ﬁngertips or palm.

The system is intended for in vitro diagnostic use only.

IMPORTANT SAFETY INFORMATION

WARNING

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 50 mg/dL follow medical

advice immediately.

• If your blood sugar reading is over 250 mg/dL, 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.

• All parts of the kit are considered biohazardous and can

potentially transmit infectious diseases, even after you have

performed cleaning and disinfection.

For complete instructions on cleaning and disinfecting your

meter and lancing device, see pages 47 to 50.

• For more information about cleaning and disinfecting your meter

or lancing device see: “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

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CONTOUR®NEXT ONE blood glucose monitoring system

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“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

• The meter and lancing device are for single patient use. Do not

share them with anyone including other family members! Do not

use on multiple patients.1,2

• The lancing device usually provided with your kit should not be

used for assisted blood draws by health care professionals or at

health care provision sites.

• 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 center. 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

CONTOUR NEXT test strips and CONTOUR®NEXT control solution.

LIMITATIONS

• 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.3-5

• Meter Operating Temperature Range: 41°F–113°F

• Control Testing Temperature Range: 59°F–95°F

• Test Strip Storage Temperature Range: 41°F–86°F

• Meter Operating Humidity Range: 10% RH–93% RH

• Sample Volume: 0.6 μL

• Measuring Range: 20 mg/dL–600 mg/dL of glucose in blood

• Altitude: Up to 20,674 feet (6301 meters) does not signiﬁcantly

affect results.

• Alternative Site Testing: See Alternative Site Testing

instructions on page 25.

• Lipemic Specimen: Cholesterol concentrations >1168 mg/dL

or triglyceride concentrations >4709 mg/dL may produce

inaccurate results.

• Peritoneal Dialysis Solutions: Icodextrin does not interfere

with CONTOUR NEXT test strips.

• Xylose: Do not use during or soon after xylose absorption

testing. Xylose in the blood will cause an interference.

• Neonatal Use: The CONTOUR NEXT ONE meter is not indicated

for neonatal use.

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CONTOUR®NEXT ONE blood glucose monitoring system

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• Always keep the CONTOUR NEXT test strips in their original

bottle. Tightly close the bottle immediately after removing a test

strip. The bottle is designed to keep the test strips dry. Do not

place or store other items or medications in the test strip bottle.

Avoid exposing meter and test strips to excessive humidity,

heat, cold, dust, or dirt. Exposure to room humidity by leaving

the bottle open or not storing the strips in their original bottle

can damage your test strips. 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.

• 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 41°F and 113°F. If meter or test strip is

outside this range, you should not test until the meter and test

strip are within this range. 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

CONTOUR 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.

• Your CONTOUR NEXT ONE meter has been preset and locked

to display results in mg/dL (milligrams of glucose per deciliter

ofblood).

vResults in mg/dL will never have a decimal point.

vResults in mmol/L will always have a decimal point.

Example: or

vCheck 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 20 mg/dL to 600 mg/dL.

vFor results over 600 mg/dL or under 20 mg/dL:

o If your blood sugar reading is under 20 mg/dL, the meter

displays the LO screen. Contact your health care

professional immediately.

o If your blood sugar reading is over 600 mg/dL, 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

600 mg/dL, 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 CONTOUR 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.

v vi

CONTOUR®NEXT ONE blood glucose monitoring system

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Ascensia, the Ascensia Diabetes Care logo, Contour,

Glucofacts, the No Coding logo, Microlet, 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. ™ = 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.

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

CONTOUR NEXT test strips and CONTOUR NEXT control solution.

vii 1

CONTOUR®NEXT ONE blood glucose monitoring system

Table of Contents

Intended Use, Important Safety Information .................................i

Your Meter Features .................................................................... vi

GETTING STARTED

Your CONTOUR NEXT ONE meter ..................................................3

The CONTOUR DIABETES app for Your ONE meter .......................6

Initial Setup from the CONTOUR DIABETES app ............................7

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

Target Ranges and Meal Markers .............................................10

TESTING

Get Ready 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 ........................50

Transfer Results to a Personal Computer ..................................50

Batteries .....................................................................................51

TECHNICAL INFORMATION

Error Detection Displays.............................................................53

Customer Service Checklist .......................................................55

Technical Information .................................................................56

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GETTING STARTED

CONTOUR®NEXT ONE blood glucose monitoring system

Symptoms of High or Low Blood Glucose.................................59

Speciﬁcations .............................................................................61

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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4 5

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 600 mg/dL.

Blood sugar test result is below 20 mg/dL.

Blood sugar test result is above Target Range.

Blood sugar test result is below Target Range.

Logbook entr y.

Meter Settings.

Fasting marker.

Before Meal marker.

After Meal marker.

Symbol What the Symbol Means

No marker selected.

A Target Range or Target setting.

Target Light (smartLIGHT) setting.

Meter is ready to test.

Add more blood to strip.

Control solution result.

Bluetooth® symbol: indicates the Bluetooth setting is On;

the meter can communicate with a mobile device.

Indicates low batteries.

Indicates dead batteries.

Indicates a meter error.

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6 7

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.

Download the CONTOUR DIABETES app

1. On your smartphone or tablet, go to the App Store® 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

CONTOUR DIABETES app to your smartphone or tablet and follow the

instructions in the app.

If you do not pair your meter with the CONTOUR 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

CONTOUR®NEXT ONE blood glucose monitoring system

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 color 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.

For a 12-hour format, select AM

or PM, press the or button,

then press the OK button.

Continue to Set the Date.

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GETTING STARTED

CONTOUR®NEXT ONE blood glucose monitoring system

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, 70 mg/dL–130 mg/dL) 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: 70 mg/dL – 130 mg/dL

Pre-set Before Meal Target Range: 70 mg/dL – 130 mg/dL

Pre-set After Meal Target Range: 70 mg/dL – 180 mg/dL

Pre-set Overall Target Range: 70 mg/dL – 180 mg/dL

Your CONTOUR NEXT ONE meter comes with Meal Markers

turned Off.

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12 13

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

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.

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:

• CONTOUR NEXT ONE meter.

• CONTOUR NEXT test strips.

• Lancing device and lancets from your kit, if provided.

To perform a quality control check, you also need CONTOUR NEXT control

solution. Some supplies are sold separately. Contact Diabetes Care

Customer Service. See the back cover for contact information.

WARNING: Potential Biohazard

• All parts of the kit are considered biohazardous and can

potentially transmit infectious diseases, even after you have

performed cleaning and disinfection, see pages 47–50.

• 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 and disinfecting your

meter and lancing device, see pages 47–50.

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 usually provided with your kit is intended for

single-patient use only. It should not be used for assisted blood

draws by health care providers or at health care provision sites,

and should never be shared with anyone else, even a family

member, due to 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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TESTING

CONTOUR®NEXT ONE blood glucose monitoring system

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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TESTING

CONTOUR®NEXT ONE blood glucose monitoring system

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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TESTING

CONTOUR®NEXT ONE blood glucose monitoring system

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

CONTOUR DIABETES app.

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

selected:

Meal Marker choices if Meal Marker feature is On

Symbol

Fasting: Use the Fasting

marker when testing blood

sugar levels after fasting (no

food or drink for 8 hours, except

water or non-caloric beverages).

Fasting Target Range

Before Meal: Use the

Before Meal 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

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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TESTING

CONTOUR®NEXT ONE blood glucose monitoring system

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 CONTOUR 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 color 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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TESTING

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LO or HI Results

• If the meter beeps twice and

displays the LO screen, your

blood sugar reading is under

20 mg/dL. 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 600 mg/dL:

1. Wash and dry your hands well.

2. Retest with a new strip.

If results are still over

600 mg/dL, 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 50 mg/dL, follow

medical advice immediately.

• If your blood sugar reading is over 250 mg/dL:

1. Wash and dry your hands well.

2. Retest with a new strip.

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

soon as possible.

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 110 mg/dL in the fasting state

and less than 140 mg/dL in the post-prandial state (after a meal).6

Youshould consult with your health care professional for glucose

values speciﬁc to your needs.

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TESTING

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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

(hypoglycemic unawareness).

• If you get alternative site blood sugar results that do not agree with

how you feel.

• During illness or times of stress.

• If you will be driving a car or operating machinery.

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 hypoglycemic 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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TESTING

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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

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Meal Marker choices if Meal Marker feature is On

Symbol What the Symbol Means Related Target Range

Fasting: Use the Fasting

marker when testing blood

sugar levels after fasting

(no food or drink for 8 hours,

except water or non-caloric

beverages).

Fasting Target Range

Before Meal: Use the

Before Meal 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 single-

patient use. Do not share them with anyone including other

family members. Do not use on multiple patients.1,2

• 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

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Control Solution

WARNING

Shake the control solution well before testing.

CAUTION: Use only CONTOUR NEXT

control solution (Level 1 and Level 2) with

your CONTOUR NEXT ONE blood glucose

monitoring system. Using anything other than

CONTOUR NEXT control solution can cause

inaccurate results.

Quality Control

• Shake the control solution bottle well, about

15 times before every use.

• Unmixed control solution may cause inaccurate

results.

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.

Level 1 and Level 2 control solutions are available and sold separately

if not included in the meter kit. You can test your CONTOUR NEXT ONE

meter with control solution when the temperature is 59°F–95°F.

Always use CONTOUR NEXT control solutions. Other brands could yield

incorrect results. If you need help locating CONTOUR NEXT control

solutions, contact Diabetes Care Customer Service. 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

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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 CONTOUR

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

CONTOUR 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

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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

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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

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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 color that corresponds to your test result.

In Target Below Target Above Target

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FEATURES

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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.

• Clean and disinfect your meter as recommended in the next

section.

The cleaning and disinfecting directions provided should not cause

any damage or degradation to the external case, buttons, or display.

Your CONTOUR NEXT ONE meter has been tested for 260 cycles of

cleaning and disinfection (equivalent to one cycle per week for 5years).

This device has been demonstrated to withstand 5years of cleaning and

disinfection without damage. You should call Diabetes Care Customer

Service for assistance if your device malfunctions for any reason or if you

notice any changes in the external meter case or display.

Cleaning and Disinfection

WARNING

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.

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.

WARNING

If your meter is being operated by a second person who is

providing testing assistance to you, the meter and lancing device

should be disinfected prior to use by the second person.

Clean and disinfect your CONTOUR NEXT ONE meter once a week.

Useonly Clorox Germicidal Wipes containing 0.55% sodium

hypochlorite (bleach). The wipes are proven safe to use with the

CONTOUR NEXT ONE meter.

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HELP

CONTOUR®NEXT ONE blood glucose monitoring system

Clorox Germicidal Wipes are available for purchase online at

http://www.ofﬁcedepot.com or http://www.amazon.com. For more

information, contact Diabetes Care Customer Service. See the back

cover for contact information.

• Cleaning involves the removal of visible dirt and debris, but does

not reduce the risk for transmission of infectious diseases.

• Disinfecting (if performed properly) reduces the risk of transmitting

infectious diseases.

Evaluate your device after performing cleaning and disinfection to

ensure that the procedure does not cloud the face/display of the

meter and does not corrode or erode the plastic housing or buttons.

For more information

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

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

Cleaning Your Meter

Supplies needed for cleaning:

• Clorox Germicidal Wipes containing 0.55% sodium hypochlorite

(bleach).

• Paper towels.

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.

1. Carefully clean the meter with germicidal wipes until all soil is

removed.

2. Dry as necessary with a clean paper towel.

Disinfecting Your Meter

Supplies needed for disinfecting:

• Clorox Germicidal Wipes containing 0.55% sodium hypochlorite

(bleach).

• Paper towels.

• Timing device.

1. Before disinfecting, clean the meter as described in Cleaning

Your Meter.

For proper disinfection, you must keep all meter surfaces wet for

60 seconds.

2. Using a new germicidal wipe, carefully wipe all outer surfaces of

your meter until wet.

Buttons Test Strip Port

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HELP

CONTOUR®NEXT ONE blood glucose monitoring system

3. After wiping for 60 seconds, use a clean paper towel to dry the

meter surfaces and the test strip port.

Cleaning and Disinfecting Your Lancing Device

Refer to the lancing device insert provided with your kit

for detailed instructions for cleaning and disinfecting the

lancing device.

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

CONTOUR DIABETES app on page 7 and follow the app instructions

to pair your meter and get started.

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.

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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.

WARNING

Keep batteries away from children. Many types of batteries

are poisonous. If swallowed, immediately contact your

poison control center.

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 CONTOUR NEXT ONE

blood glucose meter, CONTOUR NEXT

test strips, and CONTOUR NEXT

control solution available when

you call.

2. Locate the model number (A) and

serial number (B) on the back of

the meter.

3. Locate the test strips’ expiration date on the bottle.

4. Check the battery status.

Parts Information

To replace missing parts or reorder supplies, contact Diabetes Care

Customer Service. See the back cover for contact information.

• Two 3-volt CR2032 or DL2032 Coin Cell Batteries.

• CONTOUR NEXT ONE user guide.

• CONTOUR NEXT ONE quick reference guide.

• CONTOUR NEXT test strips.

• CONTOUR NEXT control solution level 1.

• CONTOUR NEXT control solution level 2.

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

• Lancets, as in your kit, if provided.

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TECHNICAL INFORMATION

CONTOUR®NEXT ONE blood glucose monitoring system

Technical Information: User Accuracy

The CONTOUR NEXT ONE blood glucose monitoring system was

tested by 372 lay users using capillary blood samples and three

CONTOUR NEXT test strip lots. The results were compared to the YSI

Glucose Analyzer laboratory reference method, traceable to the CDC

hexokinase method. The following accuracy results were obtained.

Table 1: System accuracy results for glucose concentration

< 75 mg/dL

Difference range in values

between YSI laboratory

reference method and

CONTOUR NEXT ONE meter

Within

± 5

mg/dL

Within

± 10

mg/dL

Within

± 15

mg/dL

Number (and percent) of samples

within speciﬁed range

14 of 17

(82.4%)

16 of 17

(94.1%)

16 of 17

(94.1%)

Table 2: System accuracy results for glucose concentration

≥ 75 mg/dL

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

288 of 355

(81.1%)

342 of 355

(96.3%)

354 of 355

(99.7%)

Table 3: System accuracy results for glucose concentrations

between 32.2 mg/dL and 458 mg/dL

Within ± 15 mg/dL or ± 15%

370 of 372 (99.5%)

Technical Information: Precision

A measurement repeatability study was conducted with the

CONTOUR NEXT ONE blood glucose monitoring system using

5 venous whole blood specimens with glucose levels from

43 mg/dL to 333 mg/dL. 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,

mg/dL

Pooled

Standard

Deviation,

mg/dL

95% CI of SD,

mg/dL

Coefﬁcient of

Variation, %

43.7 0.9 0.83–0.98 2.1

77.6 1.2 1.14–1.35 1.6

129.3 1.8 1.62–1.92 1.4

205.3 2.9 2.6 5 – 3.13 1.4

331.7 3.9 3.63–4.29 1.2

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 each of 10 instruments on 10 separate

days for a total of 300 readings. The following precision results were

obtained.

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TECHNICAL INFORMATION

CONTOUR®NEXT ONE blood glucose monitoring system

Table 2: System intermediate precision results for

CONTOUR NEXT ONE meter using CONTOUR NEXT test strips

Control

Level

Mean,

mg/dL

Pooled

Standard

Deviation,

mg/dL

95% CI of SD,

mg/dL

Coefﬁcient

Variation, %

142.0 0.6 0.55–0.65 1.4

2123.6 1.5 1.38 –1.63 1.2

3363.1 5.4 4.97–5.89 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 (Hypoglycemia):

• shakiness

• sweating

• fast heartbeat

• blurred vision

• confusion

• passing out

• seizure

• irritability

• extreme hunger

• dizziness

High blood glucose (Hyperglycemia):

• frequent urination

• excessive thirst

• blurred vision

• increased fatigue

• hunger

Ketones (Ketoacidosis):

• shortness of breath

• nausea or vomiting

• very dry mouth

WARNING

If you are experiencing any of these symptoms, test

your blood sugar. If your test result is under 50 mg/dL or

above 250 mg/dL, 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

the device. The device has been tested and found to comply with the

limits for a Class B digital device. The device generates, uses, and can

radiate radio frequency energy.

If you have questions, contact Diabetes Care Customer Service. See

back cover for contact information.

Speciﬁcations

Test Sample: Capillary whole blood only

Test Result: Referenced to plasma/serum glucose

Sample Volume: 0.6 μL

Measuring Range: 20 mg/dL–600 mg/dL 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: 41°F–113°F

Control Testing Temperature Range: 59°F–95°F

Meter Operating Humidity Range: 10% RH–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

Radio Frequency Technology: Bluetooth Smart

Radio Frequency Band: 2.4 GHz–2.483 GHz

Maximum Radio Transmitter Power: 1 mW

Modulation: Gaussian Frequency Shift Keying (GFSK)

Federal Communications Commission (FCC) Certiﬁed

Device

This equipment has been tested and found to meet the limits for a

Class B digital device, pursuant to part 15 of the FCC Rules. These

limits are designed to provide reasonable protection against harmful

interference in a residential installation. This equipment generates,

uses, and can radiate radio frequency energy and, if not installed

and used in accordance with the instructions, may cause harmful

interference to radio communications. However, there is no guarantee

that interference will not occur in a particular installation. If this

equipment does cause harmful interference to radio or television

reception, which can be determined by turning the equipment off and

on, the user is encouraged to try to correct the interference by one or

more of the following measures:

• Reorient or relocate the receiving antenna.

• Increase the separation between the equipment and receiver.

This portable transmitter with its antenna complies with FCC/IC RF

exposure limits for general population/uncontrolled exposure.

This device complies with part 15 of the FCC Rules. Operation is

subject to the following 2 conditions: (1) This device may not cause

harmful interference, and (2) this device must accept any interference

received, including interference that may cause undesired operation.

Compliance with these guidelines means that under normal, daily

circumstances, the device should not affect the operation of other

devices. In addition, the device should operate normally in the

presence of other devices.

In the event there is interference from another device, it is

recommended that you increase the distance between the meter and

that device. You can also turn off the interfering device. In addition,

you can turn off Bluetooth wireless technology on the meter.

Changesor modiﬁcations to the device not expressly approved by

Ascensia Diabetes Care could void the user’s authority to operate

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TECHNICAL INFORMATION

CONTOUR®NEXT ONE blood glucose monitoring system

Electromagnetic Compatibility (EMC): The CONTOUR NEXT ONE

meter complies with the electromagnetic requirements speciﬁed in

IEC 60601-1-2 Edition 4.0. Electromagnetic emissions are low and

unlikely to interfere with other nearby electronic equipment, nor are

emissions from nearby electronic equipment likely to interfere with the

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

requirements of IEC 61000-4-2 for immunity to electrostatic discharge.

The CONTOUR NEXT ONE meter meets the requirements of IEC

61000-4-3 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.

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

Batch Code

Control Discard Date

Consult instructions for use

In Vitro Diagnostic Medical Device

Control Solution – Level 1, Level 2

Shake 15 times

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).7

References

1. 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

2. 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

3. Wickham NWR, et al. Unreliability of capillary blood glucose in

peripheral vascular disease. Practical Diabetes. 1986;3(2):100.

4. Atkin SH, et al. Fingerstick glucose determination in shock.

Annals of Internal Medicine. 1991;114(12):1020-1024.

5. 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.

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TECHNICAL INFORMATION

CONTOUR®NEXT ONE blood glucose monitoring system

6. American Diabetes Association. Standards of medical care in

diabetes—2016. Diabetes Care. 2016;39(supplement 1):S15.

7. Burtis CA, Ashwood ER, editors. Tietz Fundamentals of Clinical

Chemistry. 5th edition. Philadelphia, PA: WB Saunders Co;

2001;444.

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., CONTOUR 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 CONTOUR NEXT test strips, and therefore

does not warrant the performance of the CONTOUR NEXT ONE

meter when used with any test strips other than CONTOUR NEXT test

strips or when the CONTOUR 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 CONTOUR NEXT control

solution.

6. Ascensia Diabetes Care makes no warranty regarding the

performance of the CONTOUR NEXT ONE meter or test results when

used with any software other than the CONTOUR DIABETES app

(where supported) or the GLUCOFACTS 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.

Some States do not allow the exclusion or limitation of incidental or

consequential damages, so the above limitation or exclusion may not

apply to you. This warranty gives you speciﬁc legal rights and you may

also have other rights which vary from State to State.

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, 51

Low Batteries ........................................................................ 5, 51

Replacement ............................................................................. 51

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

CONTOUR DIABETES app for Your ONE meter ..................................... 6

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

Customer Service Checklist ............................................................. 55

Error Detection Displays ................................................................... 53

GLUCOFACTS DELUXE diabetes management software .............. 50, 65

Initial Setup from the CONTOUR 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 ................................................................................... 61

Symptoms of High or Low Blood Glucose ....................................... 59

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

Target Settings.................................................................................... 8

Technical Information ....................................................................... 56

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 ................................. 50

Transfer Results to the CONTOUR DIABETES app ....................... 50

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

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

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Distributed by:

Ascensia Diabetes Care US, Inc.

5 Wood Hollow Road

Parsippany, NJ 07054 USA

www.contourone.com

1-800-348-8100

Customer Service is available Monday through Sunday, 8:00 am through Midnight,

Eastern Time

www.contourone.com

For information on patents and related licenses, see www.patents.ascensia.com.

Purchase of this product does not alone confer a license to use under these patents.

Such a license only arises, and extends only to, when the CONTOUR 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, Microlet, the

No Coding logo, 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. ™ = 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.

85025015 Rev. 08/16

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Ascensia Diabetes Care US O5 Contour Next One Blood Glucose Monitoring System User Manual Manual

Ascensia Diabetes Care US Inc. Contour Next One Blood Glucose Monitoring System Manual

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