Contour NEXT EZ User Manual Download

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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).

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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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

(Flashing)

Press

Result is

marked as a

pre-meal test.

You can now

set a reminder.

Reminder

Press

(Flashing)

Press

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

(Flashing)

Press

Result is

marked as

a post-meal

test.*

Logbook

Press

(Flashing)

Press

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.

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

LUCOFACTS®

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

LUCOFACTS

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.

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

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.

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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.

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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).

Turn oﬀ your meter before changing

your batteries.

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.

Make sure you are

using C

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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

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.

• 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.

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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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, %

0.8

1.7

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

with C

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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: C

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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.

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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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:

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

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

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

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EZ blood glucose meter when used

with any test strips other than C

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test strips,

and therefore does not warrant the performance of the

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EZ meter when used with any test strips other

than C

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test strips or when the C

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test strip is altered or modiﬁ ed in any manner.

5. Ascensia Diabetes Care makes no warranty regarding

the performance of the C

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EZ meter or test

results when used with any control solution other than

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control solution.

6. Ascensia Diabetes Care makes no warranty regarding

the performance of the C

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EZ meter or

test results when used with any software other than

the C

ONTOUR®

IABETES

app (where supported) or the

LUCOFACTS

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

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EZ user guide

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test strips

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control solution, Level 1

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control solution, Level 2

90007891_CntrNxtEZ_UG_Pamphlet_EN_F1B1_v1

December 9, 2020 6:29 AM

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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