CONTOUR NEXT ONE User manual

PROCESS YPROCESS MPROCESS C PROCESS K
FILE NAME: 85096877_CntrNxtONE_UG_EN.indd NEW COMP BAN: 85096877
REV: 09/16
DESCRIPTION: Contour Next ONE Meter User Guide
DATE: 09/21/16 CLIENT: Ascensia Diabetes Care V0 01/13/16 Initial build
V1 02/03/16 DMC Annotation
V2 02/06/16 DMC Annotation
V3 04/20/16 DMC Annotation
V4 04/26/16 DMC Annotation
V5 07/07/16 DMC Annotation
V6 07/11/16 DMC Annotation
V7 07/16/16 DMC Annotation
V8 09/21/16 DMC Annotation
PROGRAM VERS: InDesign CC(2014) SKU: Multi
5050 1st Ave South
Suite #101
Seattle, WA 98134
Tel: [phone]
Fax: [phone]
MARKET: CA SPEC: 10000774658 REV 01
LANGUAGES: EN PARENT BAN: Multi BAR CODE: 85096877 (2D Matrix)
TRIM SIZE: 6” (H) x 4.5” (W) PREVIOUS BAN: N/A
UNIT of MEASURE: mmol/L MASTER REF: DCAM-69-1823 (Version 5.0)
LASER PROOF EPSONS PROOF SIGNATURE
APPROVED
RESUBMIT WITH CHANGES
APPROVED
RESUBMIT WITH CHANGES
PROJ. MGR. SIGNATURE _________________________________ DATE ____________
PROJ. MGR. SIGNATURE _________________________________ DATE ____________
PROJ. MGR. SIGNATURE _________________________________ DATE ____________
VERSION: V8
USER GUIDE
Uses only CONTOUR®NEXT blood glucose test strips.
Blood Glucose
Monitoring System
Works with the CONTOUR™DIABETES app available for download
on the App StoreSM or on Google Play™.
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INTENDED USE
The CONTOUR®NEXT ONE blood glucose monitoring system is intended
to be used for the measurement of blood glucose in both insulin and
non-insulin treated patients with diabetes as an aid for patients and
their health care professionals in monitoring the effectiveness of the
patient’s diabetes control. The CONTOUR NEXT ONE blood glucose
monitoring system is intended for self-testing by persons with diabetes
and health care professionals for use on a single patient in venous
blood and fresh capillary whole blood drawn from the fingertip or palm.
The CONTOUR NEXT ONE blood glucose monitoring system is intended
for self-testing outside the body (in vitro diagnostic use).
The CONTOUR NEXT ONE blood glucose monitoring system should
not be used for the diagnosis of or screening for diabetes or for
neonatal use. Alternative site testing (palm) should be done only
during steady state times (when glucose is not changing rapidly). The
CONTOUR®NEXT test strips are for use with the CONTOUR®NEXT ONE
blood glucose meter to quantitatively measure glucose in venous
blood and fresh capillary whole blood drawn from the fingertips or
palm. The meter is for the quantitative measurement of glucose in
whole blood from 0.6 mmol/L–33.3 mmol/L.
The meter and lancing device are for single-patient use only.
The system is intended for in vitro diagnostic use only.
INTENDED USE: CONTOUR™DIABETES app
The CONTOUR DIABETES app is intended for use by individuals with
insulin and non-insulin treated diabetes, and/or their caregivers, to
store, view, trend, and share blood glucose meter readings, either
manually entered in the app or wirelessly transmitted from the
CONTOUR family of meters. Other related health indicators which can
be captured and shown in a printable report and graphical format on a
mobile device for insulin and non-insulin treated patients with diabetes
are available to support diabetes management. The app is available
for use on supported Apple iOS and Android devices and is designed
to be used with a wirelessly enabled CONTOUR branded meter.
IMPORTANT SAFETY INFORMATION
WARNING
Serious Illness
The system should not be used to test critically ill patients.
Capillary blood glucose testing may not be clinically appropriate
for persons with reduced peripheral blood flow. Shock, severe
hypotension and severe dehydration are examples of clinical
conditions that may adversely affect the measurement of glucose
in peripheral blood.1–3
Talk to Your Health Care Professional:
• Before setting any Target Ranges in the CONTOUR DIABETES app.
• Before changing your medication based on test results.
• If your blood sugar reading is under 2.8 mmol/L follow medical
advice immediately.
• If your blood sugar reading is over 13.9 mmol/L, or the critical
level you have established with your health care professional:
1. Wash and dry your hands well.
2. Retest with a new strip.
If you get a similar result, call your health care professional
assoon as possible.
• About whether Alternative Site Testing (AST) is appropriate
for you.
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CONTOUR®NEXT ONE blood glucose monitoring system
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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.
• The lancing device 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.
• 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.
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• If your control solution test result is out of range, contact
Diabetes Care Customer Service. See the back cover for
contact information. Do not use the meter for blood glucose
testing until you resolve this issue.
• The meter is designed to give accurate blood testing results at
temperatures between 5°C and 45°C. If meter or test strip is
outside this range, you should not test until the meter and test
strip are within this range. Whenever the meter is moved from
one location to another, allow approximately 20 minutes for the
meter to adjust to the temperature of the new location before
performing a blood glucose test.
• Do not attempt to perform a blood glucose test when the
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.
• Avoid use of electronic devices in very dry environments,
especially if synthetic materials are present.
• Your CONTOUR NEXT ONE meter has been preset and locked
to display results in mmol/L (millimoles of glucose per liter
of blood).
vResults in mmol/L will always have a decimal point.
vResults in mg/dL will never 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 0.6 mmol/L to 33.3 mmol/L.
vFor results over 33.3 mmol/L or under 0.6 mmol/L:
o If your blood sugar reading is under 0.6 mmol/L, the
meter displays the LO screen. Contact your health care
professional immediately.
o If your blood sugar reading is over 33.3 mmol/L, the meter
displays the HI screen. Wash your hands or the test site.
Repeat the test with a new strip. If results are still over
33.3 mmol/L, follow medical advice immediately.
Your Meter Features
Easy: The CONTOUR NEXT ONE blood glucose monitoring system is
about simplicity. You will notice this the first time you use it.
Automatic: The 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.
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.
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Ascensia, the Ascensia Diabetes Care logo, Contour,
Glucofacts, Microlet, the No Coding logo, and
Second-Chance are trademarks and/or registered
trademarks of AscensiaDiabetes Care Holdings AG.
TM see www.ascensiadiabetes.ca/en/tm-mc
Apple and the Apple logo are trademarks of Apple Inc.,
registered in the U.S. and other countries. App Store is a
service mark of Apple Inc.
The Bluetooth® word mark and logos are registered
trademarks owned by Bluetooth SIG, Inc., and any use of such
marks by Ascensia Diabetes Care is under license.
Google Play and the Google Play logo are trademarks of
Google Inc.
(® = registered trademark. TM = unregistered trademark.
SM = service mark.)
All other trademarks are properties of their respective owners
and are used solely for informative purposes. No relationship
or endorsement should be inferred or implied.
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CONTOUR®NEXT ONE blood glucose monitoring system
Table of Contents
Intended Use, Important Safety Information .................................i
Your Meter Features .................................................................... vi
GETTING STARTED
Your CONTOUR NEXT ONE meter ..................................................3
The CONTOUR DIABETES app for Your ONE meter .......................6
Initial Setup from the CONTOUR DIABETES app ............................7
Initial Setup from the Meter ..........................................................8
Target Ranges and Meal Markers .............................................10
TESTING
Get Ready to Test .......................................................................12
Get the Blood Drop: Fingertip Testing ........................................17
Select a Meal Marker .................................................................19
About Meal Markers ...................................................................23
Turn Meal Markers On ................................................................23
Test Results ................................................................................24
Expected Test Result Values ......................................................24
LO or HI Results .........................................................................25
Alternative Site Testing (AST): Palm ...........................................25
Control Solution Testing .............................................................33
FEATURES
Logbook .....................................................................................36
Settings ......................................................................................37
Pairing Mode ..............................................................................46
HELP
Meter Care .................................................................................46
Transfer Results to the CONTOUR DIABETES app ........................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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2 3
GETTING STARTED
CONTOUR®NEXT ONE blood glucose monitoring system
Symptoms of High or Low Blood Glucose.................................60
Specifications .............................................................................62
Warranty .....................................................................................66
Index ..........................................................................................70
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 STARTED
CONTOUR®NEXT ONE blood glucose monitoring system
Your CONTOUR NEXT ONE meter Screen
Test Strip Port
Time
Test Result in Target
Meal
Marker
Date
Symbol What the Symbol Means
Blood sugar test result is in Target Range.
Blood sugar test result is above 33.3 mmol/L.
Blood sugar test result is below 0.6 mmol/L.
Blood sugar test result is above Target Range.
Blood sugar test result is below Target Range.
Logbook entry.
Meter Settings.
Fasting marker.
Before Meal marker.
After Meal marker.
Symbol What the Symbol Means
No marker selected.
A Target Range or Target setting.
Target Light (smartLIGHT) setting.
Meter is ready to test.
Add more blood to strip.
Control solution result.
Bluetooth® symbol: indicates the Bluetooth setting is On;
the meter can 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.
• Offers quick and valuable tips to help you manage your diabetes.
Download the CONTOUR DIABETES app
1. On your smartphone or tablet, go to the App StoreSM or the
GooglePlay™ store.
2. Search for the CONTOUR DIABETES app.
3. Install the CONTOUR DIABETES app.
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.
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8 9
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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10 11
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, 3.9 mmol/L–7.2 mmol/L) to let you know if your test
result is:
• within your Target Range.
• above your Target Range.
• below your Target Range.
Within Your Target Range.
Above Your Target Range.
Below Your Target Range.
You can attach a Meal Marker to your blood sugar result using the
Meal Marker feature in the meter. This feature lets you track your
blood sugar levels over time with separate target ranges for Fasting,
Before Meal, and After Meal markers.
• If you mark your test result as Fasting, the meter compares your
result against the Fasting Target Range.
• If you mark your test result as Before Meal, the meter compares
your result against the Before Meal Target Range.
• If you mark your result as After Meal, the meter compares the
result against the After Meal Target Range.
• If you do not mark the result, the meter compares your test result
against the Overall Target Range.
Symbol Target Range
Pre-set Fasting Target Range: 3.9 mmol/L–7.2 mmol/L
Pre-set Before Meal Target Range: 3.9 mmol/L–7.2 mmol/L
Pre-set After Meal Target Range: 3.9 mmol/L–10.0 mmol/L
Pre-set Overall Target Range: 3.9 mmol/L–10.0 mmol/L
Your CONTOUR NEXT ONE meter comes with Meal Markers
turned Off.
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