Contour NEXT EZ, User Manual

Page: 61 / 66

Electromagnetic Compatibility (EMC): The
C
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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
ONTOUR
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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.
4
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:
5
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
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
C
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EZ blood glucose meters and three lots of
C
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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
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.
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
C
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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
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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
C
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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
C
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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®
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
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EZ user guide
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test strips
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control solution, Level 1
C
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control solution, Level 2
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