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INTENDED USE
The C
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EZ blood glucose monitoring system
is an over the counter (OTC) device utilized for self-testing
by persons with diabetes at home for the quantitative
measurement of glucose in whole blood, is for single-patient use
only, and should not be shared. The system is intended for
self-testing outside the body (in vitro diagnostic use) and is to be
used as an aid to monitor the eff ectiveness of diabetes control.
The C
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EZ blood glucose monitoring system is
indicated for use with fresh fi ngertip capillary whole blood
samples. The clinical utility of this device is to aid in monitoring
the eff ectiveness of your diabetes control program.
The C
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EZ blood glucose monitoring system is
not intended for the diagnosis of or screening for diabetes
mellitus and is not intended for use on neonates.
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test strips are intended for self-testing by
persons with diabetes for the quantitative measurement of
glucose in whole blood samples.
The C
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control solutions are aqueous glucose
solutions intended for use in self-testing by people with diabetes
as a quality control check to verify that the C
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system is working properly.
IMPORTANT SAFETY INFORMATION
•
Read your C
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EZ meter user guide,
the lancing device insert and all instructional materials
provided in your meter kit before testing. Please follow all
instructions for use and care exactly as described to help
avoid inaccurate results.
• Used test strips and lancets are possible biohazards and
must be disposed of as medical waste.
Cleaning Your Meter
Supplies Needed for Cleaning:
• Clorox Germicidal Wipes containing 0.55% sodium
hypochlorite (bleach)
• Paper towels
1. Clean the meter with Clorox Germicidal Wipes until all soil is
removed. Do not allow cleaning solution to run into the meter
through areas such as around the buttons or the meter’s test
strip or data ports.
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 above in
Cleaning Your Meter.
For proper disinfection, you must keep all meter surfaces wet
for 60 seconds.
Signs of Deterioration
The cleaning and disinfecting directions provided should
not cause any damage or degradation to the external case,
buttons or display.
Your C
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EZ meter has been tested for 260 cycles
of cleaning and disinfection (one cycle per week for 5 years).
This device has been demonstrated to withstand 5 years of
cleaning and disinfection without damage.
You should contact Customer Service for assistance if your
device malfunctions for any cause or if you notice any changes
in the meter case or display.
Clorox Germicidal Wipes are available for purchase online
at http://www.offi cedepot.com or http://www.amazon.com,
or for more information contact Customer Service at
1-800-348-8100 (Monday through Sunday, from 8:00 am
through 12:00 Midnight, Eastern Time).
For more information see:
“FDA Public Health Notifi cation: Use of Fingerstick Devices on
More than One Person Poses Risk for Transmitting Bloodborne
Pathogens: Initial Communication” (2010)
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/
ucm224025.html
“CDC Clinical Reminder: Use of Fingerstick Devices on More
than One Person Poses Risk for Transmitting Bloodborne
Pathogens” (2010) http://www.cdc.gov/injectionsafety/
Fingerstick-DevicesBGM.html
Using a new Clorox Germicidal Wipe, carefully wipe all outer
surfaces of your meter until wet.
Do not allow cleaning solution to run into the meter through areas
such as around the buttons or the meter’s test strip or data ports.
Test Strip Port
Buttons
Data Port
2. Dry all meter surfaces and test strip port using a clean paper
towel if needed.
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.
Your Meter Display
The picture below shows all the symbols that appear on your
meter display. To view, with the meter off , press and hold or
. All display segments will appear for 10 seconds. If you need
more than 10 seconds to check the display, press and hold
or again.
Icon
What It Means
Day/month format.
The batteries are low and need to be changed, and
will remain on display until batteries are changed.
Appear if the meter is in 12 hour setup.
Indicates sound is turned on.
Thank you for choosing the C
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EZ blood
glucose monitoring system! We are proud to be your
partner in helping you manage your diabetes.
Your Meter Features
Easy: The C
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EZ blood glucose monitoring system
is about simplicity. You will notice its simple approach the fi rst
time you see it.
Automatic: Your C
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EZ meter is designed with
No Coding technology, to automatically code itself every time
you insert a C
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test strip. It will even tell you when a
test strip is underfi lled.
Programmed: Your C
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EZ meter has been
preset at the factory with the standard date and time for your
convenience.
• Your meter has been preset and locked to display results in
mg/dL (milligrams of glucose per deciliter). In some countries,
the meters are preset to display units in mmol/L (millimoles of
glucose per liter);
• Results in mg/dL will never have a decimal point;
• Results in mmol/L will always have a decimal point.
Example:
or
Check your display to ensure that results are being displayed in
mg/dL. If they are not, contact Customer Service. See Contact
Information.
Customizable: The C
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EZ meter allows you to set
personal choices for some features. For more information, see
section 3, Setup and Use.
Important Safety Information
• Always keep the test strips in the
original bottle. Tightly close the bottle
immediately after removing a test
strip. The bottle is designed to keep
the test strips dry. Exposure to room
humidity from leaving the bottle open or
not storing them in the original bottle can
damage your test strips. This could lead
to inaccurate test results.
• Always wash your hands well with soap and water and
dry them well before and after testing, handling the
meter, lancing device, or test strips.
• Test strips are for single use only. Do not use a test
strip that appears damaged or has been used.
• Your test strip is designed to easily “sip” the blood
into the sample tip. Do not drop blood directly on the fl at
surface of the test strip.
• Do not press the test strip against your fi nger when
testing. This may block the sample tip.
• Let the meter and test strips adjust to the temperature
where you are testing. Whenever the meter is moved
from one location to another, allow approximately
20 minutes for the meter to adjust to the temperature of
a new location before performing a blood glucose test.
The meter has been designed to give accurate results at
temperatures between 41°F and 113°F.
• Check the expiration dates on your test strips and
control solution. It is important to not use the test strips or
control solution if the expiration date printed on the bottle
label and carton has passed. For the control solution do
not use if it has been six months since you fi rst opened the
bottle. It will help to write the six month discard date on the
control solution label.
• For more information about cleaning and disinfecting your
meter or lancing device see:
“FDA Public Health Notifi cation: Use of Fingerstick Devices
on More than One Person Poses Risk for Transmitting
Bloodborne Pathogens: Initial Communication” (2010)
http://www.fda.gov/MedicalDevices/Safety/
AlertsandNotices/ucm224025.html
“CDC Clinical Reminder: Use of Fingerstick Devices
on More than One Person Poses Risk for Transmitting
Bloodborne Pathogens” (2010) http://www.cdc.gov/
injectionsafety/Fingerstick-DevicesBGM.html
TESTING
Important Safety Information
• Have all the materials you will need ready before you
begin testing. This includes your C
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EZ meter,
the C
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test strips, the lancing device and lancets.
You will also need C
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control solution to run a
quality control check. C
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control solutions are
sold separately if not included in the meter kit.
• The lancing device is intended for self testing by a single
patient. It must not be used on more than one person
due to the risk of infection.
• Use a new lancet each time you test because it is no
longer sterile after use.
• Do not perform a blood glucose test when the
C
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EZ meter is connected to an external device,
e.g., computer.
• Use only approved equipment from the manufacturer or
certifi ed body such as UL or TUV.
• The C
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EZ blood glucose monitoring system has
not been evaluated using capillary blood samples obtained
from sites other than the fi ngertip.
• Use only C
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test strips with your
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EZ system.
• Use only C
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control solution with your
C
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EZ system.
TESTING
2
TESTING
TESTING
TESTING
The following steps are shown in the proper order for
performing a blood glucose test.
Preparing the Test Strip
1. Wash and dry your hands well before testing.
2. Remove a C
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test strip from the bottle.
3. Hold the test strip with the gray
square end facing up.
4. Insert the gray square end into the
test strip port on the meter.
The meter will turn on. An image of a test strip with a fl ashing
blood drop
will appear letting you know the meter is
ready to test.
Preparing the Lancing Device
The lancing device graphics are for illustration purposes
only. Your lancing device may look diff erent. Refer to
your lancing device insert for detailed instructions on
preparing the lancing device.
WARNING: Potential Biohazard
The lancing device provided with your kit is intended
for self-testing by a single patient. It must not be used
on more than one person due to the risk of infection.
WARNING
• Dispose of the used lancet as medical waste or as
advised by your health care professional.
•
Do not reuse lancets. Use a new lancet each time
you test.
Getting Ready to Test
1. Remove the endcap from the lancing device.
2. Loosen the round protective cap on
a lancet by rotating the cap ¼ turn,
but do not remove the cap.
3. Insert the lancet fi rmly into the
lancing device until the lancet
comes to a complete stop.
4. Twist off the round protective lancet
cap. Save the cap for disposing of
the used lancet.
5. Replace the endcap.
6. Rotate the endcap dial to adjust
the puncture depth. The amount of
pressure applied to the puncture
site also aff ects the puncture depth.
Getting the Blood Drop and Testing
1. Press the lancing device fi rmly
against the puncture site and press
the release button.
2. Stroke your hand and fi nger towards
the puncture site to form a drop of
blood. Do not squeeze around the
puncture site .
Suggested drop size
3. Test immediately after a good blood
drop has formed .
Fingertip Testing
4. Immediately touch the tip of the test
strip to the drop of blood. The blood
is pulled into the test strip through
the tip .
Hold the tip of the test strip in the
blood drop until the meter beeps.
Do not press the tip against the skin or place the blood on top of
the test strip or you could get inaccurate results or errors.
WARNING
• 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
• All parts of the kit are considered biohazardous and
can potentially transmit infectious diseases, even
after you have performed cleaning and disinfection.
• Always wash your hands well with soap and water
and dry them well before and after testing, handling
the meter, lancing device, or test strips.
For complete instructions on cleaning and disinfecting
your meter and lancing device, see Cleaning and
Disinfection in section 2, Testing.
If the fi rst blood drop is not enough, the meter may beep twice
and display a strip underfi ll screen image
.
You have 20 seconds to apply more blood to the same strip. If
you are not able to apply enough blood within that time, an E2
error code will be displayed. Dispose of the used test strip as
medical waste and start over with a new strip.
5. After a beep, you will see the meter
count down 5 seconds and your blood
test result is displayed and automatically
stored in the meter memory. Please
do not touch the test strip during the
countdown as this may result in an error.
NOTE: You can set your meter to use meal marker options.
See Set-up for Basic (L-1) and Advanced (L-2) Modes in
section 3, Setup and Use. If you want to mark your result
you will need to do it before removing the test strip.
6. Remove the test strip to turn your meter
off . Dispose of the used test strip as
medical waste.
7. Always wash your hands well with soap
and water before and after testing,
handling the meter, lancing device, or
test strips.
Test Results
Expected Values
Blood glucose values will vary depending on food intake,
medication dosages, health, stress, or activity. Non-diabetic
plasma glucose concentrations should be < 100 mg/dL in the
fasting state and < 140 mg/dL in the post-prandial state.
3
You
should consult with your health care professional for
glucose values specifi c to your needs.
CAUTION:
• If your blood glucose reading is under 50 mg/dL, or you
see (less than 20 mg/dL) on the meter display, follow
medical advice immediately.
• If your test result is above 250 mg/dL, or you see
(greater than 600 mg/dL) on the meter display, call
your health care professional as soon as possible.
• Always consult your health care professional before
changing your medication based on C
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EZ
test results.
Ejecting and Disposing of the Used Lancet
1. Do not use your fi ngers to remove
the lancet from the lancing device.
The lancing device 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.
Do not reuse lancets. Use a new lancet each time you test.
WARNING
• Dispose of the used lancet as medical waste or as
advised by your health care professional.
• Do not reuse lancets. Use a new lancet each time you
test.
WARNING: Potential Biohazard
• Always dispose of test strip and lancet 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.
• Please refer to your lancing device package insert for
instructions on how to properly remove and dispose
of the lancet.
Cleaning and Disinfection
Your C
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EZ meter should be cleaned and
disinfected once a week. For the meter, use only Clorox
Germicidal Wipes containing 0.55% sodium hypochlorite
(bleach), which has been proven to be safe to use with the
C
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EZ meter. Refer to the lancing device
insert provided with your kit for detailed instructions for
cleaning and disinfecting the lancing device.
Cleaning is the removal of visible dirt and debris, but does not
reduce the risk for transmission of infectious diseases. Your
C
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EZ system should be cleaned of dirt and debris
once a week.
Disinfecting (if performed properly) reduces the risk of
transmitting infectious diseases. Your meter and lancing device
should be disinfected once a week.
NOTE: If the 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.
Control Solution Testing
CAUTION : Use only C
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control
solution with your C
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test strips.
Using any other control solution may cause
inaccurate results.
Quality Control
• Shake the control solution bottle well, about
15 times before every use.
• Unmixed control solution may cause
inaccurate results.
You should perform a control test when:
• Using your meter for the fi rst 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 glucose results.
WARNING
Shake the control solution well before testing.
WARNING
• Do not calibrate your continuous glucose monitoring
device from the control result.
• Do not calculate a bolus based on a control result.
CAUTION: Check the expiration date
on the test strip bottle and the expiration
and discard dates on the control solution
bottle. DO NOT use expired materials.
Level 1 and Level 2 control solutions are available and sold
separately if not included in the meter kit. You can test your
C
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EZ meter with control solution when the
temperature is 59°F – 95°F. Always use C
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control
solutions. Other brands could present incorrect results. If you
need help locating C
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control solutions, contact
Customer Service. See Contact Information.
1. Wash and dry your hands well before and after testing.
2. Remove a test strip from the bottle and fi rmly snap the lid
closed.
3. Hold the test strip with the gray square
end facing up.
4. Insert the gray square end into the test
strip port on the meter.
The meter will turn on. An image of a
test strip with a fl ashing blood drop will
appear letting you know the meter is
ready to test.
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 control
solution onto a clean nonabsorbent
surface. Do not apply control
solution to your fi ngertip or to the
test strip directly from the bottle.
8. Immediately touch the tip of the test strip to the drop of control
solution.
9. Hold the tip in the drop until the meter beeps.
10. The meter will count down for
5 seconds and the control test result
will display on the meter.
The meter will automatically recognize
and mark the control result for you.
NOTE: The does not indicate the control test result is
within the specifi ed range. It only marks it as a control
solution test. It will not be included in your averages.
11. Compare your control test result to
the ranges provided on the test strip
bottle or carton.
To turn your meter off , simply remove the
test strip. Dispose of the used test strip
as medical waste.
The result will be automatically marked
and stored in the meter memory. Control
results will not be included in your blood
glucose averages or in the 7 day HI-LO
summary.
CAUTION: If the result you get 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
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EZ meter for blood glucose testing until you
resolve the issue. Contact Customer Service. See Contact
Information.
IMPORTANT: To ensure accuracy of your blood glucose test
results and accuracy of your control test results, use only
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control solutions.
SETUP AND USE
Setting the Time, Date and Sound
Your C
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EZ meter allows you to set the date, time,
and sound as you like them.
• You can view 12 or 24 hour time;
• month/day or day.month; and
• choose to have your meter beep or not.
To get into set-up mode when the meter is off , press and hold
M for 3 seconds. A complete display will briefl y appear, then
numbers will fl ash in the top left corner of the display.
Setting the Time
With the 12H fl ashing on the display,
press or to select the 12H (with AM
and PM) or 24H setting.
Press M to set.
The number in the hour position will
now fl ash. Press or until you reach
the current hour.
Press M to set.
The minute will now fl ash. Press or
to select the current minute.
Press M to set.
SETUP AND USE
3
SETUP AND USE
SETUP AND USE
SETUP AND USE
If you selected a 12 hour time setting, the
AM or PM will now fl ash. Press or to
select AM or PM.
Press M to set.
Setting the Month and Day Format
m/d will now fl ash on the display. Press
or to select the format you wish
(m/d for month/day format or d.m for
day.month format).
Press M to set.
Setting the Date
The year will be fl ashing. Press or
to select the current year.
Press M to set.
The month will now fl ash. Press or
to select the month.
Press M to set.
The day will now fl ash. Press or to
select the day.
Press M to set.
Setting the Sound
The fl ashing bell symbol will now appear
on the display along with the word .
This option controls whether you want to
hear the beep sound during testing.
To turn the beep sound off during testing,
press or to display .
Press M to set.
After setting the sound, will fl ash.
To keep your meter in Basic Mode,
press M to set. To change your meter to
Advanced Mode, press or to change
to , and press M to set.
If you are using Basic Mode (L-1 will
appear on your display), you have
completed your meter set-up.
Set-up for Basic (L-1) and
Advanced (L-2) Modes
Your new C
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EZ meter is pre-set for the Basic Mode
and off ers the same easy test procedure in either the Basic or
Advanced Mode.
BASIC MODE (L-1)
ADVANCED MODE (L-2)
• 7 day HI and LO summary
• 14 day average
• 480 test result memory
• 7 day HI and LO summary
• 7, 14, and 30 day averages
• 480 test result memory
• Pre- and post-meal
markers
• 30 day pre- and post-meal
averages
• Selectable post-meal
reminders (2.5, 2.0, 1.5,
1.0 hours)
• Personal HI and LO test
settings
BASIC MODE (L-1)
ADVANCED MODE (L-2)
Your meter is pre-set to Basic
Mode. If you have set your
meter to the Advanced Mode,
and want to return to Basic
Mode:
1. Press M to turn your meter
on. Wait to see the fl ashing
test strip.
2. Press and hold or for
3 seconds.
3. L-2 will fl ash.
4. Press or to change to
L-1.
5. Press M to set.
To set your meter to
Advanced Mode, and take
advantage of meal markers
and other functions available
to you:
1. Press M to turn your meter
on. Wait to see the fl ashing
test strip.
2. Press and hold or for
3 seconds.
3. L-1 will fl ash.
4. Press or to change to
L-2.
5. Press M to set.
Personalizing LO, HI and Reminder
Settings
If you selected Advanced Mode
(L-2 on your display) you can change
your meter’s personal low and
high blood glucose settings. By
personalizing these settings, your
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EZ meter will help you
track these HI and LO results.
The LO setting will fl ash (default
72 mg/dL). To change this setting, press
or until you reach your desired LO
setting, and then press M to set.
(The range of values for LO is
60 mg/dL – 90 mg/dL.)
Your HI blood glucose setting will now
fl ash (default 180 mg/dL). To change,
press or until you reach your
desired HI setting. Press M to set.
(The range of values for HI is
100 mg/dL – 250 mg/dL.)
Post-Meal Test Reminder Set-up
To change the reminder time for post-
meal testing, press or to display
the options available. Select 2.5, 2.0,
1.5, or 1.0 hour(s) to set your post-meal
reminder (default is 2.0 hours).
Press M to set.
You have now completed your
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EZ meter set-up for
Advanced Mode!
Using the Markers
If you have set up your meter in
Advanced Mode, your meter will
display three markers after you test
your blood.
Pre-meal = Marks a test result
that was taken before a meal.
Post-meal = Marks a test result
that was taken after a meal.
Logbook = The logbook marker can be used to mark any
result as being unique or diff erent in some way, and for which
you may want to make notes in your logbook. Seeing a result
with this symbol next to it in the memory will help remind you
that there is more information recorded about this test result.
Please see the following panels to use these options.
If you do not want to mark the test result
Remove the used test strip to automatically save the test result
in the meter memory with no markers. This will also turn the
meter off .
GETTING STARTED
Your C
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EZ meter
Your C
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test strip
GETTING STARTED
1
GETTING STARTED
GETTING STARTED
GETTING STARTED
Table of Contents
1 GETTING STARTED
Your Meter and Test Strip
Meter Display and Symbols
Meter Features
2 TESTING
Prepare the Test Strip and Lancing Device
Fingertip Testing
Understand Test Results
Clean and Disinfect Your Meter
Test with Control Solution
3 SETUP AND USE
Set Time, Date, and Sound
Set Basic (L-1) and Advanced (L-2) Modes
Customize LO, HI, and Reminder Settings
Mark Your Test Results
Transfer Results to a Computer
View Basic and Advanced Mode Results
4 TECHNICAL, SERVICE & CARE
Error Codes
Replace the Batteries
Meter Care
High and Low Blood Glucose
Meter Specifi cations
Customer Service and Manufacturer Warranty
Order Meter Kit Supplies
WARNING
• 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
• All parts of the kit are considered biohazardous
and can potentially transmit infectious diseases,
even after you have performed cleaning and
disinfection.
• Always wash your hands well with soap and
water and dry them well before and after testing,
handling the meter, lancing device, or test strips.
• For complete instructions on cleaning and
disinfecting your meter and lancing device, see
Cleaning and Disinfection in section 2, Testing.
• This device is not intended for use in healthcare or
assisted-use settings such as hospitals, physician
offi ces, or long-term care facilities because it has
not been cleared by FDA for use in these settings,
including for routine assisted testing or as part of
glycemic control procedures.
• Use of this device on multiple patients may lead to
transmission of Human Immunodefi ciency Virus
(HIV), Hepatitis C Virus (HCV), Hepatitis B Virus
(HBV), or other bloodborne pathogens.
CONTACT INFORMATION
Customer Service is available Monday through Sunday, 8:00 am
through 12:00 Midnight, Eastern Time. If this is a medical emergency, please
contact your health care professional or dial 911. To leave a message for Customer
Service, remain on the line. One of our representatives will return your call as soon
as possible.
1-800-348-8100
Distributed by:
Ascensia Diabetes Care US Inc.
5 Wood Hollow Road
Parsippany, NJ 07054
www.diabetes.ascensia.com
For information on patents and related licenses,
see: www.patents.ascensia.com .
Ascensia, the Ascensia Diabetes Care logo, Clinilog, Contour, Glucofacts,
and the No Coding logo are trademarks and/or registered trademarks of
Ascensia Diabetes Care Holdings AG.
All other trademarks are the property of their respective owners.
While all characters are displayed,
it is very important to verify that
is fully displayed. If there
are missing segments, see Error
Codes and Symbols in section 4,
Technical, Service & Care. This may
aff ect the way you see your results.
Icon
What It Means
Top area on the display presenting date and time.
Pre-meal result marker.
Post-meal result marker.
Identifi es a Logbook entry.
Indicates a reminder has been set.
Center area on the display that shows either your
test result or any error codes.
The meter is ready to test.
Control solution result marker .
Indicates it is too cold or too hot for your meter to
test accurately .
Indicates Average .
Results are displayed as mg/dL or mmol/L.
The 7 appears when viewing 7 day HI-LO summary.
• Examine product for missing, damaged, or broken parts.
If the test strip bottle is open inside the new box of strips,
do not use those strips. Contact Customer Service for
replacement parts. See Contact Information.
Blood Glucose Monitoring System
USER GUIDE
Uses only C
ONTOUR®
N
EXT
blood glucose test strips.
Online meter registration available at
www.diabetes.ascensia.com or call our
Customer Service.
90007891_CntrNxtEZ_UG_Pamphlet_EN_F1B1_v1
December 9, 2020 6:29 AM
90007891 Rev. 11/20
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DATE:
CLIENT:
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SGK JOB#:
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DIMENSIONS:
PRINTER SPEC:
RELEASE: V-1
LANGUAGE(S):
ENGLISH
INTERNAL: R-X
BAN#:90007891
Rev. 11/20
Cntr Nxt EZ Mtr UG Pamphlet - US
Alt#1 - 12/09/20 unmask
December 09, 2020
Ascensia Diabetes Care
Cntr Nxt EZ Mtr UG Pamphlet - English
402154695
Multi Parent BAN# Multi
673 mm (W) x 764 mm (H)
101005614 REV B
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