background image

Electromagnetic Compatibility (EMC):  The 

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 EZ meter complies with the electromagnetic 

requirement specifi ed in ISO 15197:2013. Electromagnetic 

emissions are low and unlikely to interfere with other nearby 

electronic equipment, nor are emissions from nearby electronic 

equipment likely to interfere with the C

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 EZ meter. 

The C

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 EZ meter meets the requirements of IEC 

61000-4-2 for immunity to electrostatic discharge. Avoid use 

of electronic devices in very dry environments, especially if 

synthetic materials are present. The C

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 EZ meter 

meets the requirements of IEC 61326-1 for radio frequency 

interference. To avoid radio frequency interference, do not 

use the C

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 EZ meter near electrical or electronic 

equipment that are sources of electromagnetic radiation, as 

these may interfere with the proper operation of the meter. 
Principles of the Procedure:  The C

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 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 dehydrogenase (FAD-GDH) and the 

mediator. Electrons are generated, producing a current that is 

proportional to the glucose in the sample. After the reaction 

time, the glucose concentration in the sample is displayed. No 

calculation is required. 
Comparison Options:  The C

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 EZ system 

is designed for use with capillary whole blood. Capillary 

samples should be applied directly to the C

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test strip. Comparison to a laboratory method must be done 

simultaneously with aliquots of the same sample.  
NOTE: Glucose concentrations drop rapidly due to 

glycolysis (approximately 5% – 7% per hour).

6

 System Specifi cations 

Test Sample:  Capillary whole blood 
Test Result:  Glucose measurements are reported as plasma 

equivalents. 
Sample Volume:  0.6 µL 
Measuring Range:  20 mg/dL–600 mg/dL 
Results:  5-second countdown 
Memory Feature:  Stores most recent 480 test results 
Battery Type:  Two 3-volt lithium batteries, 225 mAh capacity 

(DL2032 or CR2032) 
Battery Life:  Approximately 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 fi lled with blood, or when a test 

result appears on the display. Two beeps sound when the meter 

turns off  or to indicate an error. You will hear twenty beeps when 

a programmed reminder sounds.  

Technical Information

 The C

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 EZ blood glucose monitoring system was 

tested by 115 lay users using capillary blood samples and three 

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 test strip lots. The results were compared to the 

YSI Glucose Analyzer 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 

Diff erence range 

in values between 

YSI laboratory 

reference method 

and C

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 EZ 

meter

Within 

± 5 

mg/dL

Within 

± 10 

mg/dL

Within 

± 15 

mg/dL*

Number (and percent) 

of samples within 

specifi ed range

6 of 7 

(85.7%)

7 of 7 

(100.0%)

7 of 7 

(100.0%)

After performing a test

To Mark 

Results

You Will 

See

To Set

You Will See

What It Means

Pre-Meal

Press 

or 

(Flashing)

Press 

M

Result is 

marked as a 

pre-meal test. 

You can now 

set a reminder.

Reminder

Press 

or 

(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

Viewing Advanced Mode Results

In Advanced Mode (L-2), you have all of the options described in 

Basic Mode plus additional items available. 

Press M

 to turn your meter on. Briefl y 

press M 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.

NOTES: 
• 

Averages include the specifi ed time period plus the 

current day. 

•  The meter 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.

Transferring Results to a Computer

You can transfer test results from the C

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 EZ meter 

to a computer, where they can be summarized in a report 

with graphs and tables. To make use of this feature, you need 

G

LUCOFACTS®

D

ELUXE

 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 C

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 EZ meter has 

not been tested for use with any software other than 

G

LUCOFACTS

 D

ELUXE

 software. Ascensia Diabetes Care is not 

responsible for any erroneous results from the use of other 

software.

Viewing Basic Mode Results 

Press M to turn your meter on. Press M again to view the 

memory. 

The 14 day average will appear in the 

center of the display with the number of 

results shown at the top of the display. 

Control results are not included in this 

14 day average.

Press   to view the 7 day high and 

low 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 

backward through the results. 

When 

 appears on the display, you 

have viewed all of the results in the 

memory.

Viewing Advanced Mode Averages

Press M to turn your meter on. Press M again to view the 

14 day average including the number of results used to 

obtain the average.

Press   to view the 7 day high and 

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.

Press again to view the 30 day 

average 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.

       TECHNICAL, SERVICE & CARE 

Error Codes and Symbols

What You See What It Means What You Should Do

(will remain on 

the display)

Low batteries.

Replace the batteries 

as soon as possible.

(will fl ash for 

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.

     

     

     

What You See What It Means What You Should Do

E7

Incorrect test 

strip.

Remove the test strip 

and retest using a new 

test strip. Make certain 

that you are using a 

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 test 

strip.

E10

Invalid date or 

time.

This error occurs 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 

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 test 

strips should be used.

Changing the Batteries 

Batteries should be replaced when the 

meter continually displays 

 or the 

meter briefl y shows 

 and then turns 

off  

(see Error Codes and Symbols in 

section 4, Technical, Service & Care).

1. 

Turn off  your meter before changing 

your batteries. 

2. 

Press fi rmly 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 which will raise 

the bottom of the battery up. 

4. Place new batteries under the prongs 

and into the battery compartment 

with the “+” side up. [Use two 3-volt 

(DL2032 or CR2032) lithium batteries.] 

5. Slide the battery cover back into place, 

lining up with the open slots, and close 

fi rmly.

Ascensia Diabetes Care off ers 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.

 Symptoms of High or Low Blood Glucose 

 You can better understand your test results by being aware of 

the symptoms of high or low blood glucose.
According to the American Diabetes Association, some of the 

most common symptoms are:

 Low blood glucose (Hypoglycemia):   

•   shakiness 

•   sweating 

•   fast  heartbeat 

•   blurred  vision 

•   confusion 

•   passing  out 

•   irritability 

•   seizure 

•   extreme  hunger 

•   dizziness 

 High blood glucose (Hyperglycemia): 

•   frequent  urination 

•   excessive  thirst 

•   blurred  vision 

•   increased  fatigue 

•   hunger 

 Ketones  (Ketoacidosis): 

•   shortness of breath 

•   nausea or vomiting 

•   very dry mouth 

   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 experiencing any of these symptoms, 

test your blood glucose. If your test result is under 

50 mg/dL or above 250 mg/dL, contact your 

health care professional immediately. 

What You See What It Means What You Should Do

Control test 

result is out 

of range (too 

high or too 

low).

Test strip or 

control solution 

is past the 

expiration date 

or is past the 

discard date.

Check all expiration 

dates and discard 

dates. Do not use 

expired testing 

materials.

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.

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control solution.

Meter could be 

damaged.

If result is still out 

of range, contact 

Customer Service. See 

Contact Information.

Caring for Your Meter

•  Store meter in the carrying case provided whenever possible.

•  Wash and dry hands well before handling to keep 

the meter and test strips free of water, oils and other 

contaminants.

•  Handle the meter carefully to avoid damaging the electronics 

or causing other malfunctions.

•  Avoid exposing 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).

What You See What It Means What You Should Do

Some display 

segments do 

not appear 

when the 

meter initially 

turns on.

Possible meter 

electronics 

failure.

Compare meter display 

with the 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 aff ect 

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.

What You See What It Means What You Should Do

E2

The test strip has 

not fi lled enough 

for an accurate 

test. Insuffi  cient 

blood drop.

Remove the test strip 

and retest using a new 

test strip. Wait until you 

see the fl ashing blood 

drop on the display 

before testing.

E3

•  The meter is 

sensing a used 

test strip. 

•  The wrong 

control solution 

was used.

•  Remove the test strip 

and retest using a 

new test strip. Wait 

until you see the 

fl ashing blood drop 

on the display before 

testing. 

•  If control testing, 

make sure to use 

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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 test strip 

and retest using a 

new test strip. If you 

continue to have 

problems, contact 

Customer Service. See 

Contact Information.

 A repeatability study was conducted with the C

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 EZ 

blood glucose monitoring system using fi ve venous whole 

blood specimens with glucose levels from 47 to 326 mg/dL. 

Multiple replicates (n=100 per lot) were tested using multiple 

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 EZ blood glucose meters and three lots of 

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 blood glucose test strips. The following precision 

results were obtained.  
 System repeatability results for C

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 EZ meter 

using C

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 test strips 

Mean, mg/dL

Pooled Standard 

Deviation

Coeffi  cient 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

Limitations

Altitude:  Up to 20,674 feet (6,301 meters) does not 

signifi cantly aff ect results. 

Alternative Site Testing:  Not for use with Alternative Site 

Testing. 
Lipemic Specimen:  Cholesterol concentrations >1,168 mg/dL 

or triglyceride concentrations >4,709 mg/dL may produce 

inaccurate results. 
Peritoneal Dialysis Solutions:  Icodextrin does not interfere 

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 test strips. 

Xylose: Do not use during or soon after xylose absorption 

testing. Xylose in the blood will cause an interference. 
Hematocrit: 
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 test strip results are not 

signifi cantly aff ected 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 

fl ow. Shock, severe hypotension and severe dehydration are 

examples of clinical conditions that may adversely aff ect the 

measurement of glucose in peripheral blood.

7

Interference:  Certain substances occurring in the blood 

naturally (uric acid, bilirubin) or from therapeutic treatments 

(ascorbic acid, acetaminophen) will not signifi cantly aff ect 

results. The limiting concentrations of these compounds are 

listed on your test strip insert.  

Symbols Used

The following symbols are used throughout the product labeling 

for the C

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 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

Table 2 – System accuracy results for glucose 

concentration ≥ 75 mg/dL

Diff erence 

range in values 

between YSI 

laboratory 

reference 

method and 

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 EZ 

meter

Within 

± 5%

Within 

± 10%

Within 

± 15%

Within 

± 20%*

Number (and 

percent) of 

samples within 

specifi ed 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.

Using the Reminder Feature 

When the reminder sounds, the meter 

will automatically turn on. The reminder 

will beep 20 times, and the display will 

show the pre-meal test result you marked 

when you set the reminder. Pressing any 

button will silence the reminder.

You can now run another test by placing a test strip in the test 

strip port and following the testing instructions (see section 2, 

Testing).

When you have completed this test and 

the result is shown on the display,   will 

fl ash. 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 reminder set.

To Cancel a Reminder 

When the meter is off , press 

M to turn on 

the meter. The date and time will appear 

along with the  .
Press   or   twice and the reminder icon 

will disappear.
Press M to cancel the reminder.

 Service  Information 

 If you have a problem and none of the problem solving steps in 

this user guide help, contact Customer Service. See Contact 

Information. We have trained specialists to help you. 
Important 
•  Speak to a Customer Service Representative before 

returning your meter for any reason. He/she will give 

you the information needed to get your problem handled 

correctly and effi  ciently. 

•  Have your C

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 EZ blood glucose meter and 

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 test strips available when you phone. It 

would also be helpful to have a bottle of C

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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

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test strips’ expiration date 

on the bottle.

_____________________

3. Check the battery icon on 

the display. (See Changing 

the Batteries in section 4,

Technical, Service & Care.)

Warranty

Manufacturer’s Warranty: Ascensia Diabetes Care warrants 

to the original purchaser that this instrument will be free from 

defects in materials and workmanship for 5 years from the date 

of original purchase (except as noted below). During the stated 

5-year period, Ascensia Diabetes Care shall, at no charge, 

replace a unit found to be defective with an equivalent or current 

version of the owner’s model.
Limitations of Warranty: This warranty is subject to the 

following exceptions and limitations:
1. A 90-day warranty only will be extended for consumable parts 

and/or accessories.

2. This warranty is limited to replacement due to defects in parts 

or workmanship. Ascensia Diabetes Care shall not be required 

to replace any units that malfunction or are damaged due to 

abuse, accidents, alteration, misuse, neglect, maintenance 

by someone other than Ascensia Diabetes Care, or failure 

to operate the instrument in accordance with instructions. 

Further, Ascensia Diabetes Care assumes no liability for 

malfunction of or damage to Ascensia Diabetes Care 

instruments caused by the use of test strips or control solution 

other than the appropriate products recommended by 

Ascensia Diabetes Care (i.e., C

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 test strips and 

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 control solutions).

3. Ascensia Diabetes Care reserves the right to make changes in 

the design of this instrument without obligation to incorporate 

such changes into previously manufactured instruments.

What You See What It Means What You Should Do

Test result is 

above 

600 mg/dL.

•  Wash and dry your 

hands well and the 

test site. Repeat the 

test using a new test 

strip. 

•  If your result still 

fl 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 

fl ashes 

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.

If you want to mark the test result

Before you remove your test strip, press   or   to select the 

marker you want to set. The marker will fl ash.

To mark a result with the pre-meal 

marker, press M when the 

 fl ashes.

The 

 will then fl ash. This feature 

allows 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 fl ashing. 

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 

fl ashes. Press 

M to set.

To mark a result with the logbook, press   or   until the

fl ashes. Press 

M to set.

References

1. 

 US Food and Drug Administration. Use of fi ngerstick 

devices on more than one person poses risk for transmitting 

bloodborne pathogens: initial communication. US Department 

of Health and Human Services; update 11/29/2010. 

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/

ucm224025.htm 

2. Centers for Disease Control and Prevention. CDC clinical 

reminder: use of fi ngerstick devices on more than one person 

poses risk for transmitting bloodborne pathogens. 

US Department of Health and Human Services; 

8/23/2010. http://www.cdc.gov/injectionsafety/Fingerstick-

DevicesBGM.html

3. 

American Diabetes Association. 2. Classifi cation 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 Association, www.diabetes.org

6. Burtis CA, Ashwood ER, editors. Tietz Fundamentals of 

Clinical Chemistry. 5th edition. Philadelphia, PA: WB Saunders 

Co; 2001;444.

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

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

4. Ascensia Diabetes Care has not validated the performance 

of the C

ONTOUR

 N

EXT

 EZ blood glucose meter when used 

with any test strips other than C

ONTOUR

 N

EXT

 test strips, 

and therefore does not warrant the performance of the 

C

ONTOUR

 N

EXT

 EZ meter when used with any test strips other 

than C

ONTOUR

 N

EXT

 test strips or when the C

ONTOUR

 N

EXT

test strip is altered or modifi ed in any manner.

5. Ascensia Diabetes Care makes no warranty regarding 

the performance of the C

ONTOUR

 N

EXT

 EZ meter or test 

results when used with any control solution other than 

C

ONTOUR

 N

EXT

 control solution.

6. Ascensia Diabetes Care makes no warranty regarding 

the performance of the C

ONTOUR

 N

EXT

 EZ meter or 

test results when used with any software other than 

the C

ONTOUR®

D

IABETES

 app (where supported) or the 

G

LUCOFACTS

 D

ELUXE

 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 

DAMAGES, EVEN IF ASCENSIA DIABETES CARE HAS BEEN 

ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

Some States do not allow the exclusion or limitation of 

incidental or consequential damages, so the above limitation 

or exclusion may not apply to you. This warranty gives you 

specifi c legal rights and you may also have other rights which 

vary from State to State.
For warranty service: Purchaser must contact 

Ascensia Diabetes Care Customer Service for assistance and/

or instructions for obtaining service of this instrument. 

See Contact Information.

Supplies

Replacement Parts

To replace missing parts or reorder supplies, call Customer 

Service. See Contact Information.
Item
Two 3-volt lithium batteries DL2032 or CR2032 
C

ONTOUR

 N

EXT

 EZ user guide

C

ONTOUR

 N

EXT

 test strips

C

ONTOUR

 N

EXT

 control solution, Level 1

C

ONTOUR

 N

EXT

 control solution, Level 2

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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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