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

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Blood Glucose
Monitoring System
Works with the CONTOUR™DIABETES app available for download
on the App Store or on Google Play™.
®
Uses only CONTOUR®NEXT blood glucose test strips.
USER GUIDE
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PROCESS C
PROCESS M
PROCESS Y
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PROCESS K
FILE NAME: 85025015_CntrNxtONE_UG_EN.indd
DESCRIPTION: Onyx Contour NEXT ONE Meter User Guide
5050 1st Ave South
Suite #101
Seattle, WA 98134
Tel: 206.587.0800
Fax: 206.587.0356
NEW COMP BAN: 85025015
REV: 08/16
DATE: 08/18/16
CLIENT: Ascensia Diabetes Care
PROGRAM VERS: InDesign CC(2014)
SKU: MULTI
MARKET: US
SPEC: 10000774658 REV 01
LANGUAGES: EN
PARENT BAN: MULTI
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
APPROVED
APPROVED
RESUBMIT WITH CHANGES
RESUBMIT WITH CHANGES
V0
V1
V2
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V4
V5
V6
V7
09/23/15
10/19/15
10/24/15
11/11/15
04/19/16
05/02/16
08/11/16
08/18/16
Initial build
DMC Annotation
DMC Annotation
DMC Annotation
DMC Annotation
DMC Annotation
DMC Annotation
DMC Annotation
BAR CODE: 85025015 (2D)
VERSION: V7
SIGNATURE
PROJ. MGR. SIGNATURE _________________________________ DATE ____________
PROJ. MGR. SIGNATURE _________________________________ DATE ____________
PROJ. MGR. SIGNATURE _________________________________ DATE ____________
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.
85025015_CntrNxtONE_UG_EN.indd 1-2
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
CONTOUR®NEXT ONE blood glucose monitoring system
ii
8/18/16 10:05 AM
•
•
•
•
•
•
“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/FingerstickDevicesBGM.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.
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
iii
85025015_CntrNxtONE_UG_EN.indd 3-4
•
•
•
•
•
•
•
•
•
•
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.
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.
CONTOUR®NEXT ONE blood glucose monitoring system
iv
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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.
85025015_CntrNxtONE_UG_EN.indd 5-6
• Your CONTOUR NEXT ONE meter has been preset and locked
to display results in mg/dL (milligrams of glucose per deciliter
of blood).
v Results in mg/dL will never have a decimal point.
v Results in mmol/L will always have a decimal point.
or
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 20 mg/dL to 600 mg/dL.
v For 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.
CONTOUR®NEXT ONE blood glucose monitoring system
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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.
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.
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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
CONTOUR®NEXT ONE blood glucose monitoring system
8/18/16 10:05 AM
GETTING STARTED
Symptoms of High or Low Blood Glucose.................................59
Specifications .............................................................................61
Warranty .....................................................................................64
Index ..........................................................................................66
Your CONTOUR NEXT ONE meter
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
Test Strip Port
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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CONTOUR®NEXT ONE blood glucose monitoring system
8/18/16 10:05 AM
GETTING STARTED
Your CONTOUR NEXT ONE meter Screen
Symbol
Time
Test Result in Target
What the Symbol Means
No marker selected.
A Target Range or Target setting.
Meal
Marker
Target Light (smartLIGHT) setting.
Meter is ready to test.
Add more blood to strip.
Test Strip Port
Date
Control solution result.
Bluetooth® symbol: indicates the Bluetooth setting is On;
the meter can communicate with a mobile device.
Symbol
What the Symbol Means
Indicates low batteries.
Blood sugar test result is in Target Range.
Indicates dead batteries.
Blood sugar test result is above 600 mg/dL.
Indicates a meter error.
Blood sugar test result is below 20 mg/dL.
Blood sugar test result is above Target Range.
Blood sugar test result is below Target Range.
Logbook entry.
Meter Settings.
Fasting marker.
Before Meal marker.
After Meal marker.
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GETTING STARTED
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.
85025015_CntrNxtONE_UG_EN.indd 6-7
• 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.
OR
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.
CONTOUR®NEXT ONE blood glucose monitoring system
8/18/16 10:05 AM
GETTING STARTED
Initial Setup from the Meter
Set the Time
The hour is blinking.
OK Button
1. To change the hour, press the
Press and hold the OK button for 2 seconds until the meter turns on.
or
button on the outer ring.
Outer Ring
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.
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.
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.
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CONTOUR®NEXT ONE blood glucose monitoring system
8/18/16 10:05 AM
GETTING STARTED
Set the Date
The year is blinking.
1. To change the year, press the
OK button.
or
Above Your Target Range.
button, then press the
Below Your Target Range.
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:
your Target Range.
• within
your Target Range.
• above
your Target Range.
• below
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
Within Your Target Range.
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Your CONTOUR NEXT ONE meter comes with Meal Markers
turned Off.
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TESTING
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.
12
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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.
CONTOUR®NEXT ONE blood glucose monitoring system
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TESTING
4. Twist off the round protective
lancet cap. Save the cap for
disposing of the used lancet.
1. Remove the endcap from the
lancing device.
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2. Loosen the round protective cap
on a lancet by rotating the cap
¼ turn, but do not remove the cap.
5. Replace the endcap.
3. Insert the lancet firmly into the
lancing device until the lancet
comes to a complete stop.
6. Rotate the endcap dial to adjust
the puncture depth.
The amount of pressure applied
to the puncture site also affects
puncture depth.
CONTOUR®NEXT ONE blood glucose monitoring system
15
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TESTING
Insert the Test Strip
Get the Blood Drop: Fingertip Testing
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.
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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
Select a Meal Marker
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.
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 ,
marker is blinking on the blood sugar
After Meal , or No Mark
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:
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.
Do not press the OK button yet.
OK Button
You can select the blinking marker or
choose a different 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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OK Button
1. If the blinking Meal Marker is
the one you want, press the
OK button
or
Outer Ring
2. To select another Meal Marker,
press the or button on
the outer ring to scroll between
markers.
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TESTING
Meal Marker choices if Meal Marker feature is On
Symbol
What the Symbol Means
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).
Before Meal: Use the
Before Meal marker when
testing blood sugar levels
within 1 hour before a meal.
After Meal: Use the
After Meal marker when
testing blood sugar levels
within 2 hours after the first
bite of a meal.
No Mark Selected: Use
the No Mark symbol when
testing at times other than
after fasting or before or
after a meal.
Related Target Range
Fasting Target Range
Before Meal
Target Range
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
After Meal Target Range
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:
Overall Target Range
Example: If you scroll up to Fasting, the Fasting marker blinks.
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:
Example: If you scroll down to After Meal, the After Meal
marker blinks:
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TESTING
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.
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.
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
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.
4. To move to the Home screen,
press the OK button.
or
5. To turn the meter off, remove
the test strip.
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TESTING
Test Results
LO or HI 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.
• 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.
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TESTING
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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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.
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TESTING
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.
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.
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.
Do not press the OK button yet.
OK Button
OK Button
Outer Ring
85025015_CntrNxtONE_UG_EN.indd 28-29
4. If the blinking Meal Marker is
the one you want, press the
OK button
or
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.
28
You can select the blinking marker or
choose a different Meal Marker.
5. To select another Meal Marker,
press the or button on
the outer ring to scroll between
markers.
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TESTING
Meal Marker choices if Meal Marker feature is On
Symbol
What the Symbol Means
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).
Before Meal: Use the
Before Meal marker when
testing blood sugar levels
within 1 hour before a meal.
After Meal: Use the
After Meal marker when
testing blood sugar levels
within 2 hours after the first
bite of a meal.
No Mark Selected: Use
the No Mark symbol when
testing at times other than
after fasting or before or
after a meal.
Related Target Range
Fasting Target Range
Before Meal
Target Range
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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
After Meal Target Range
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.
30
Eject and Dispose of the Used Lancet
• 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.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
Control Solution
WARNING
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.
• 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
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.
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
8. Immediately touch the tip of the test strip to the drop of control solution.
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.
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.
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.
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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.
CONTOUR®NEXT ONE blood glucose monitoring system
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FEATURES
Logbook
Settings
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.
In Settings you can:
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.
is blinking.
The Logbook
2. To select the blinking Logbook
symbol, press the OK button.
3. To view your individual test results, press the
button.
• 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.
4. To scroll through your test results,
press the or button.
To scroll faster, press and hold the
or
OK Button
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
symbol.
to go to the Home screen, then select the Logbook
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
Change the Time
The time format is blinking.
1. To change the time format, if needed, press the
then press the OK button.
4. Continue to press the OK button until you see the Date
Format screen.
or
button,
or
Time Format
The hour is blinking.
2. To change the hour, press the
or button, then press the
OK button.
The minutes are blinking.
3. To change minutes, press the
or button, then press the
OK button.
4. For a 12-hour time format, select AM or PM, as needed, then press
the OK button.
Change the Date
or
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.
If your meter is not ON:
1. Press and hold the OK button until the meter turns on.
and Settings .
The Home screen has 2 options: Logbook
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
Set the Sound
Set Meal Markers
If your meter is not ON:
1. Press and hold the OK button until the meter turns on.
and Settings
The Home screen has 2 options: Logbook
If your meter is not ON:
1. Press and hold the OK button until the meter turns on.
and Settings
The Home screen has 2 options: Logbook
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.
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.
or
or
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.
40
85025015_CntrNxtONE_UG_EN.indd 40-41
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
View Target Ranges
7. To move to the next Target
Range, press the OK button.
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.
and Settings
The Home screen has 2 options: Logbook
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.
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.
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.
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.
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In Target
Below Target
Above Target
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FEATURES
If your meter is not ON:
1. Press and hold the OK button until the meter turns on.
and Settings .
The Home screen has 2 options: Logbook
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.
or
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.
and Settings .
The Home screen has 2 options: Logbook
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.
Target Light Symbol:
5. To turn Target Lights On or Off, press the
the option you want.
6. Press the OK button.
or
button to display
or
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
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:
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
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.
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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
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
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.
Cleaning Your Meter
Supplies needed for cleaning:
• Clorox Germicidal Wipes containing 0.55% sodium hypochlorite
(bleach).
• Paper towels.
Buttons
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Test Strip Port
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HELP
3. After wiping for 60 seconds, use a clean paper towel to dry the
meter surfaces and the test strip port.
CAUTION: Use only approved equipment from the manufacturer
or certified body such as UL, CSA, TUV, or CE.
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.
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.
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
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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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TECHNICAL INFORMATION
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.
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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
E1
Too Little Blood
E2
Used Test Strip
E3
Strip Upside Down
E4
Wrong Strip Inserted
E6
Moisture Damaged Strip
E8
Strip or Test Errors
Remove the strip. Repeat
the test with a new strip.
Remove the strip. Repeat
the test with a new strip.
Remove the strip and insert
it correctly.
Remove the strip. Repeat the
test with a CONTOUR NEXT
test strip.
Remove the strip. Repeat
the test with a new strip.
Repeat the test with a new
strip. If the error persists,
contact Customer Service.
Testing Errors
E20
Testing Error
E24
Too Cold to Test Control
Solution
Repeat the test with a new
strip. If the error persists,
contact Customer Service.
Move the meter, strip, and
control solution to a warmer
area. Test in 20 minutes.
CONTOUR®NEXT ONE blood glucose monitoring system
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TECHNICAL INFORMATION
Error Code
What it Means
E25
Too Hot to Test Control
Solution
E27
Too Cold to Test
E28
Too Hot to Test
What to Do
Move the meter, strip, and
control solution to a cooler
area. Test in 20 minutes.
Move the meter and strip to
a warmer area. Test in 20
minutes.
Move the meter and strip
to a cooler area. Test in 20
minutes.
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.
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.
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85025015_CntrNxtONE_UG_EN.indd 54-55
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.
CONTOUR®NEXT ONE blood glucose monitoring system
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TECHNICAL INFORMATION
Technical Information: User Accuracy
Technical Information: Precision
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
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
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
Number (and percent) of samples
within specified range
Within
± 5%
Within
± 10%
Within
± 15%
288 of 355 342 of 355 354 of 355
(81.1%)
(96.3%)
(99.7%)
Table 3: System accuracy results for glucose concentrations
between 32.2 mg/dL and 458 mg/dL
Mean,
mg/dL
Pooled
Standard
Deviation,
mg/dL
95% CI of SD,
mg/dL
Coefficient of
Variation, %
43.7
77.6
129.3
205.3
331.7
0.9
1.2
1.8
2.9
3.9
0.83–0.98
1.14–1.35
1.62–1.92
2.65–3.13
3.63–4.29
2.1
1.6
1.4
1.4
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.
Within ± 15 mg/dL or ± 15%
370 of 372 (99.5%)
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CONTOUR®NEXT ONE blood glucose monitoring system
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TECHNICAL INFORMATION
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
42.0
123.6
363.1
0.6
1.5
5.4
95% CI of SD,
mg/dL
Coefficient
of
Variation, %
0.55–0.65
1.38–1.63
4.97–5.89
1.4
1.2
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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CONTOUR®NEXT ONE blood glucose monitoring system
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TECHNICAL INFORMATION
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
60
85025015_CntrNxtONE_UG_EN.indd 60-61
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)
CONTOUR®NEXT ONE blood glucose monitoring system
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TECHNICAL INFORMATION
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.
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
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
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85025015_CntrNxtONE_UG_EN.indd 62-63
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.
CONTOUR®NEXT ONE blood glucose monitoring system
63
8/18/16 10:06 AM
TECHNICAL INFORMATION
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.
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.
64
CONTOUR®NEXT ONE blood glucose monitoring system
Warranty
85025015_CntrNxtONE_UG_EN.indd 64-65
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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
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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
CONTOUR®NEXT ONE blood glucose monitoring system
67
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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.
5025015_CntrNxtONE_UG_EN.indd 68
© 2016 Ascensia Diabetes Care Holdings AG.
All rights reserved.
85025015 Rev. 08/16
8/18/16 10:06 AM

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