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INTENDED USE 

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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. 

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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. 
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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. 
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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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 EZ 

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. 
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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.
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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, 

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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 

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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. 

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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 

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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. 

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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 

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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

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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 

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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 

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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 

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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 

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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 

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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 

       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

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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 

C

ONTOUR

 N

EXT

 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 

C

ONTOUR

 N

EXT

 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

ONTOUR®

N

EXT

 EZ  meter  

  Your   C

ONTOUR

 N

EXT

  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

© 2020 Ascensia Diabetes Care Holdings AG. 

All rights reserved.

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DESCRIPTION:

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

FONTS:

Helvetica World

COLORS:

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Black

NOTE: THIS COLOR PROOF INDICATES COLOR BREAK ONLY AND MAY NOT ACCURATELY REFLECT ACTUAL PRODUCTION COLOR.

Regional Master Template No: XXXX

Clinical Trial / Global Master Template No: 0208_R0005

Summary of Contents for NEXT EZ

Page 1: ...Blood Glucose Monitoring System USER GUIDE Uses only CONTOUR NEXT blood glucose test strips Online meter registration available at www diabetes ascensia com or call our Customer Service ...

Page 2: ...ssible 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 tradema...

Page 3: ...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 Specifications Customer Service and Manufacturer Warranty O...

Page 4: ...EXT 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 CONTOUR NEXT test strips are intended for self testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples The CONTOUR NEXT control solutions are aqueous glucose solutions intended for use in self testing by p...

Page 5: ...ing 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 offices 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 tr...

Page 6: ...GETTING STARTED Your CONTOUR NEXT EZ meter Your CONTOUR NEXT test strip GETTING STARTED 1 GETTING STARTED 1 GETTING STARTED GETTING STARTED 3 ...

Page 7: ...or Codes and Symbols in section 4 Technical Service Care This may affect 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 Identifies 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...

Page 8: ...pproach the first time you see it Automatic Your CONTOUR NEXT EZ meter is designed with No Coding technology to automatically code itself every time you insert a CONTOUR NEXT test strip It will even tell you when a test strip is underfilled Programmed Your CONTOUR NEXT EZ meter has been preset at the factory with the standard date and time for your convenience Your meter has been preset and locked t...

Page 9: ...t 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 flat surface of the test strip Do not press the...

Page 10: ...ard date on the control solution label For more information about cleaning and disinfecting your meter or lancing device see FDA Public Health Notification 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 Device...

Page 11: ...f 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 CONTOUR NEXT EZ meter is connected to an external device e g computer Use only approved equipment from the manufacturer or certified body such as UL or TUV The CONTOUR NEXT EZ blood glucose monitoring system has not been evaluated using capillary blood samples obtai...

Page 12: ...R NEXT 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 flashing blood drop will appear letting you know the meter is ready to test 9 ...

Page 13: ...tions 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 10 ...

Page 14: ...ove the cap 3 Insert the lancet firmly into the lancing device until the lancet comes to a complete stop 4 Twist off the round protective lancet cap Save the cap for disposing of the used lancet 5 Replace the endcap 6 Rotate the endcap dial to adjust the puncture depth The amount of pressure applied to the puncture site also affects the puncture depth 11 ...

Page 15: ...ke your hand and finger 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 12 ...

Page 16: ...cluding 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...

Page 17: ...ur 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 ...

Page 18: ...h your health care professional for glucose values specific 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 profe...

Page 19: ...ancet 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 t...

Page 20: ...sinfecting the lancing device Cleaning is the removal of visible dirt and debris but does not reduce the risk for transmission of infectious diseases Your CONTOUR NEXT 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 ...

Page 21: ...er case or display Clorox Germicidal Wipes are available for purchase online at http www officedepot 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 Notification Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bl...

Page 22: ... 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 ...

Page 23: ...uch 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 20 ...

Page 24: ...ontrol solution may cause inaccurate results You should perform a control test when Using your meter for the first time You open a new bottle or package of test strips You think your meter may not be working properly You have repeated unexpected blood glucose results WARNING Shake the control solution well before testing WARNING Do not calibrate your continuous glucose monitoring device from the co...

Page 25: ...use CONTOUR NEXT control solutions Other brands could present incorrect results If you need help locating CONTOUR NEXT 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 firmly snap the lid closed 3 Hold the test strip with the gray square end facing up 4 Insert the gray square end into...

Page 26: ...n onto a clean nonabsorbent surface Do not apply control solution to your fingertip or to the test strip directly from the bottle 8 Immediately touch the tip of the test strip to the drop of control solution 9 Hold the tip in the drop until the meter beeps 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...

Page 27: ...mory 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 CONTOUR NEXT EZ meter for blood glucose testing ...

Page 28: ...old M for 3 seconds A complete display will briefly appear then numbers will flash in the top left corner of the display Setting the Time With the 12H flashing 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 flash Press or until you reach the current hour Press M to set The minute will now flash Press or to select the curre...

Page 29: ... flash 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 flashing Press or to select the current year Press M to set The month will now flash Press or to select the month Press M to set The day will now flash Press or to select the day Press M to set 26 ...

Page 30: ...d during testing To turn the beep sound off during testing press or to display Press M to set After setting the sound will flash 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 27 ...

Page 31: ...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 28 ...

Page 32: ...ee the flashing test strip 2 Press and hold or for 3 seconds 3 L 2 will flash 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 flashing test strip 2 Press and hold or for 3 seconds 3 L 1 will flash 4 Press or to change to L 2 5 Press M to set 29 ...

Page 33: ...ter will help you track these HI and LO results The LO setting will flash 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 flash 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 ...

Page 34: ...nder 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 CONTOUR NEXT EZ meter set up for Advanced Mode 31 ...

Page 35: ...esult as being unique or different 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 r...

Page 36: ...you to set a reminder to remind you to run a post meal test The reminder is available only after setting a pre meal marker If you want to set the reminder press M The will appear and stop flashing If you do not want to set the reminder press or and the will disappear Press M to set To mark a result with the post meal marker press or until the flashes Press M to set To mark a result with the logbook ...

Page 37: ...d this test and the result is shown on the display will flash To mark this test as a post meal result press M If you do not want to mark this test remove the test strip to turn the meter off Dispose of the used test strip as medical waste If you decide not to test after the reminder sounds press any button to turn your meter off The meter will only set one reminder at a time It will remember the last...

Page 38: ... Flashing Press M Reminder is set to go off in the amount of time you have set 1 0 2 5 hours to remind you to run a post meal test Post Meal Press or Flashing Press M Result is marked as a post meal test Logbook Press or Flashing Press M Result is marked in memory as unique You should note this in your logbook Post meal glucose measurements should be made 1 2 hours after the beginning of the meal 4...

Page 39: ...ACTS DELUXE software and a data cable For a free download of the software go to www glucofacts ascensia com or contact Customer Service See Contact Information May not be available in all countries IMPORTANT The CONTOUR NEXT EZ meter has not been tested for use with any software other than GLUCOFACTS DELUXE software Ascensia Diabetes Care is not responsible for any erroneous results from the use o...

Page 40: ...w summary At the top of the display you will see the number of HI results above 180 mg dL and LO results below 72 mg dL during the preceding 7 day period and the total number of results during that period Press twice to review previous results Results will be shown starting with the most recent Each result will show the date and time the test was taken You can press or to scroll forward or backwar...

Page 41: ...ter will hold 480 results in the memory When the maximum is reached the oldest test result will be removed as a new test is completed and saved to the memory Press M to turn the meter off or it will automatically turn off after 3 minutes represents the number of test results 38 ...

Page 42: ...again to view the 14 day average including the number of results used to obtain the average Press to review previous results Results will be shown starting with the most recent Each result will show the date and time the test was taken You can press or to scroll forward or backward through the results When appears on the display you have viewed all of the results in the memory 39 ...

Page 43: ...nd low summary At the top of the display you will see the number of HI and LO results In the center of the display is the total number of results Press to view the 7 day average You will see the average in the center of the display and the number of results along the top Press to view the 30 day average This will display the average in the center and the number of readings along the top 40 ...

Page 44: ...rage of results marked with a pre meal marker Press again to view the 30 day average of results marked with a post meal marker Press again and you will see Press M to turn the meter off or it will automatically turn off after 3 minutes 41 ...

Page 45: ...10 seconds and then the meter will turn off Dead batteries Replace the batteries The meter is ready to test Proceed with the testing of your blood Not enough blood sample Add more blood within 20 seconds E1 Temperature out of range Move to an area that is within the operating range for the meter 41 113 F Let the meter adjust to this temperature for 20 minutes before performing a test 4 4 42 ...

Page 46: ...s used Remove the test strip and retest using a new test strip Wait until you see the flashing blood drop on the display before testing If control testing make sure to use CONTOUR NEXT control solution E4 Test strip not inserted correctly Remove and reinsert the test strip properly see Preparing the Test Strip in section 2 Testing E5 E9 E6 E12 E8 E13 Potential software or hardware issue Remove the ...

Page 47: ...rs only in Communication mode See Setting the Time Date and Sound in section 3 Setup and Use to reset the date or time If you continue to see this error please contact Customer Service See Contact Information E11 Abnormal result Remove the test strip and retest using a new test strip Be sure you wash and dry your hands well and carefully follow instructions in this user guide Only CONTOUR NEXT tes...

Page 48: ...ashes HI contact your health care professional as soon as possible Test result is below 20 mg dL Repeat the test using a new test strip If your result still flashes LO follow medical advice immediately CAUTION Glucose levels above 250 mg dL may indicate a potentially serious medical condition CAUTION Glucose levels below 50 mg dL may indicate a potentially serious medical condition 45 ...

Page 49: ...ls Test strip is deteriorated due to heat or exposure to moisture Run another control test with a new test strip and control solution Control solution is not at room temperature or may not be mixed well Shake the control solution bottle well about 15 times before every use Incorrect control solution was used Make sure you are using CONTOUR NEXT control solution Meter could be damaged If result is ...

Page 50: ... illustration in Your Meter Display in section 1 Getting Started If the display is not correct contact Customer Service See Contact Information Results are not displayed in expected units of measure mg dL This may affect the way you see your results Contact Customer Service See Contact Information If you do not resolve the problem contact Customer Service See Contact Information 47 ...

Page 51: ... 2 Press firmly on the battery cover and slide in the direction of the arrow NOTE If you put the new batteries in the meter within 5 minutes of taking the old ones out all your settings and results will be saved If you take more than 5 minutes you will need to reset the date and time although your other settings and results will be saved 3 Remove the old batteries by pressing the top of the battery...

Page 52: ...h the open slots and close firmly Ascensia Diabetes Care offers the Free Batteries for Life Program When your batteries are low please contact Customer Service See Contact Information WARNING Keep batteries away from children Lithium batteries are poisonous If swallowed immediately contact your doctor or poison control center Discard batteries according to your local environmental regulations 49 ...

Page 53: ...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 meter and test strips to excessive humidity heat cold dust or dirt Clean and disinfect your meter as recommended in Cleaning and Disinfection in section 2 Testing 50 ...

Page 54: ...zziness High blood glucose Hyperglycemia frequent urination excessive thirst blurred vision increased fatigue hunger Ketones Ketoacidosis shortness of breath nausea or vomiting very dry mouth For additional information and a complete list of symptoms contact your health care professional or refer to the website of the American Diabetes Association www diabetes org Information For Safety If you are...

Page 55: ...ximately 1000 tests 1 yr average use Meter Operating Temperature Range 41 F 113 F Control Solution Operating Temperature Range 59 F 95 F Meter Operating Humidity Range 10 RH 93 RH Dimensions 3 03 H x 2 24 W x 0 74 T 77 mm H x 57 mm W x 19 mm T Weight 1 7 oz 47 5 grams Sound A beep sounds when the meter is turned on a test strip is inserted when a test strip is filled with blood or when a test resul...

Page 56: ... radiation as these may interfere with the proper operation of the meter Principles of the Procedure The CONTOUR NEXT EZ blood glucose test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the strip The blood sample is drawn into the tip of the test strip through capillary action Glucose in the sample reacts with FAD glucose ...

Page 57: ... test strip results are not significantly affected by hematocrit levels in the range of 15 to 65 Contraindications 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 ...

Page 58: ... the CONTOUR NEXT EZ blood glucose monitoring system meter packaging and labeling and reagent and control solution packaging and labeling Symbol What It Means Batch code Use by Date last day of month Consult instructions for use In Vitro Diagnostic Medical Device Shake 15 times 55 ...

Page 59: ...er laboratory reference method traceable to the CDC hexokinase method The tables below show how well the two methods compared Table 1 System accuracy results for glucose concentration 75 mg dL Difference range in values between YSI laboratory reference method and CONTOUR NEXT EZ meter Within 5 mg dL Within 10 mg dL Within 15 mg dL Number and percent of samples within specified range 6 of 7 85 7 7 of...

Page 60: ...in 15 Within 20 Number and percent of samples within specified range 83 of 108 76 9 104 of 108 96 3 107 of 108 99 1 108 of 108 100 0 Acceptance criterion is that 95 of the measured glucose values shall fall within either 15 mg dL of the average measured values of the reference measurement procedure at glucose concentrations 75 mg dL or within 20 at glucose concentrations 75 mg dL 57 ...

Page 61: ...tes n 100 per lot were tested using multiple CONTOUR NEXT EZ blood glucose meters and three lots of CONTOUR NEXT blood glucose test strips The following precision results were obtained System repeatability results for CONTOUR NEXT EZ meter using CONTOUR NEXT test strips Mean mg dL Pooled Standard Deviation Coefficient of Variation 47 0 8 1 7 84 1 1 1 3 139 2 1 1 5 202 2 6 1 3 326 5 0 1 5 58 ...

Page 62: ...ntly Have your CONTOUR NEXT EZ blood glucose meter and CONTOUR NEXT test strips available when you phone It would also be helpful to have a bottle of CONTOUR NEXT control solution nearby Check List This check list may be helpful when speaking with Customer Service A B 1 Locate the serial number A and model number B on the back of the meter _____________________ _____________________ 2 Locate the C...

Page 63: ...placement 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 dama...

Page 64: ...ONTOUR DIABETES app where supported or the GLUCOFACTS DELUXE software where supported from ASCENSIA DIABETES CARE ASCENSIA DIABETES CARE MAKES NO OTHER EXPRESS OR IMPLIED 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 DAM...

Page 65: ...ens US Department of Health and Human Services 8 23 2010 http www cdc gov injectionsafety Fingerstick DevicesBGM html 3 American Diabetes Association 2 Classification and diagnosis of diabetes Standards of medical care in diabetes 2020 Diabetes Care 2020 43 supplement 1 S14 S31 4 American Diabetes Association Clinical Practice Recommendations Diabetes Care 2011 34 1 S1 S96 5 American Diabetes Assoc...

Page 66: ...ts or reorder supplies call Customer Service See Contact Information Item Two 3 volt lithium batteries DL2032 or CR2032 CONTOUR NEXT EZ user guide CONTOUR NEXT test strips CONTOUR NEXT control solution Level 1 CONTOUR NEXT control solution Level 2 63 ...

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