MHC Medical Products Easy-Touch User manual

Easy•Touch® Test Strip Instructions
For Testing Glucose in Capillary Whole Blood
IMPORTANT: Please read this information and your
Easy•Touch® Glucose Monitoring System's user
manual before using Easy•Touch® Glucose Test Strips.
Intended Use
The Easy•Touch® Glucose Test Strips are used with the
Easy•Touch® Blood Glucose Meter for quantitatively
measuring glucose (sugar) in whole blood obtained from the
fingertip, palm and forearm. The Easy•Touch® Glucose Test
Strips are for testing outside the body (in vitro diagnostic
use). The Easy•Touch® Blood Glucose Meter is intended
for use in the home and in professional settings to monitor
blood glucose levels.
Test Principle
On each test strip there is a test area containing reaction
chemicals. When blood is applied to this area, a chemical
reaction takes place, then a transient electrical current
is formed. The blood glucose concentration is calculated
based on the electrical current detected by the meter, then
the result is showed on the display. The test measures
glucose from 20 mg/dL (1.1mmol/L) to 600 mg/dL (33.3
mmol/L). The Easy•Touch® Glucose Test Strip is calibrated
to display the equivalent of plasma glucose values to allow
easy comparison of results with laboratory methods.
Precautions
• For
in vitro diagnostic use (outside the body) only.
• Do not reuse test strips.
• Do not use test strips beyond the expiration date printed
on the package since this may cause inaccurate results.
• Discard the vial and any unused test strips 3 months
after you first open it. Constant exposure test strips to air
may destroy chemicals in the test strip. This damage can
cause incorrect readings.
• The sample must only be applied to the tip of the test
strip. Do not apply blood or control solution to the top, left
or right sides of the test strip. This may cause inaccurate
test results.
• Use only the Easy•Touch® Blood Glucose Meter with the
Easy•Touch® Glucose Test Strips.
• Keep the test strip vial away from children. The cap is a
choking hazard. The cap or vial contains drying agents
to protect the test strips. Drying agents may be harmful if
inhaled or swallowed and may cause skin or eye irritation.
• Any change in medication based on the Easy•Touch®
Blood Glucose Meter test results without the consent
and advice of a physician or healthcare professional
is not recommended. Consult your physician or
healthcare professional before making changes in
your treatment plan based on your blood glucose test
results.
• Severe dehydration and excessive water loss may cause
false low results. If you believe you are suffering from
severe dehydration, consult your physician immediately.
• All devices contaminated with blood should be disposed
of properly. Healthcare professionals should follow their
institution’s infection control protocols.
• If you get Easy•Touch® Control Solution test results that
fall outside the range printed on the test strip vial, repeat
the test with a new test strip. If the test result is still outside
the range printed on the test strip vial, the Easy•Touch®
System may not be working properly. DO NOT use the
system to test your blood until you get a control solution
test result within the range printed on the test strip
vial label.
Storage and Handling
• Store
at room temperature between 39-86 (4-30 ).
Do not refrigerate or freeze. Avoid exposing test strips to
extreme temperatures.
• Store away from direct sunlight and heat.
• Use each strip immediately after removing it from the vial.
• Store your test strips in their original vial only. The cap or
vial contains drying agents to protect the test strips. Do
not transfer test strips to a new vial or any other container.
• After removing a test strip from the vial, replace the vial
cap immediately and close it tightly.
• Do not bend, cut, or alter the Test Strip in any way.
• With clean, dry hands you may gently touch the test strip
anywhere when removing it from the vial or inserting it into
the meter.
How to do the Test
See your User’s Manual for a step-by-step guide on how to
do the test.
Warning
Alternate site testing (AST) should ONLY be used in the
following intervals:
• In a pre-meal or fasting state.
(more than 2 hours since the last meal)
• Two hours or more after taking insulin.
• Two hours or more after exercise.
DO NOT use AST if:
• You think your blood glucose is low.
• You are unaware of hypoglycemia.
• Your AST results do not match the way you feel.
• You are testing for hyperglycemia.
• Your routine glucose results are often fluctuating.
• If you are pregnant.
1. Select the Puncture Site to Obtain Blood
You may obtain a blood drop from the fingertip, palm,
or forearm. If using the forearm, choose a fleshy area
away from bone, visible veins and hair. If using the palm,
choose a fleshy area on the palm below your thumb or
pinky finger. Select a spot with no visible veins and away
from deep lines, which may cause your blood sample
to smear. Wash your hands and the puncture site with
warm, soapy water. Dry them thoroughly. If you use an
alcohol swab, make sure the skin is dry before lancing.
To help you get a large enough drop of blood, you may
gently massage or apply warmth to the site to increase
blood flow. Press and hold the sampler against your
fingertip, palm or forearm for a few seconds, then press
the release button.
2. Blood Glucose Testing
Insert a Test Strip to the meter. The meter will turn on.
Use the Lancing Device to obtain the right size blood
drop. Refer to your Lancing Device User’s Instruction for
how to lance your finger, forearm and palm. Then obtain
a blood sample about the size of a pinhead.
Gently touch only one edge of the Test Strip to the blood
sample. You may fill the blood to the tip of test strip.
Do not apply blood to the top, left or right sides of
the test strip. Do not press the edge of the strip against
the test site. When the strip is full of blood, the meter
will “beep” or you will see the test strip chamber area
completely filled.
3. Read Results
Read the test results in an average of 5 seconds. The
result will be stored in the meter memory.
Results are displayed as mg/dL (milligrams per deciliter
of blood) or mmol/L (millimoles per liter of blood)
depending on the units you chose when you set up your
meter. To change the units displayed, see your User’s
Manual section “Setting Up the Meter.” (The mg/dL is the
standard unit in the United States. Meters used in the
United States must be set to read in mg/dL)
What Do Your Results Mean?
Normal Glucose Values
The normal fasting glucose range for a non-diabetic adult
is 70 to 110 mg/dL (3.9 to 6.1 mmol/L)1. One to two hours
after meals, normal glucose values should be less than 140
mg/dL (7.8 mmol/L).2 For people with diabetes, consult your
physician or healthcare professional for the target glucose
values that are right for you.
Low Glucose Values
The Easy•Touch® Blood Glucose Meter displays results
between 20 and 600 mg/dL (1.1 and 33.3 mmol/L). If your
test result is lower than 20, “Low” (LO) will appear on
the meter display. This indicates severe low blood sugar
(hypoglycemia). You should immediately treat low blood
sugar as recommended by your healthcare professional.
High Glucose Values
If your test result is above 600 mg/dL (33.3 mmol/L), “High”
(HI) will appear on the meter display screen. This indicates
severe high blood sugar (hyperglycemia). You should
immediately treat high blood sugar as recommended by
your healthcare professional.
Unexpected Results
Low or high blood sugar readings can indicate a potentially
serious medical condition. If your blood sugar is unusually
low or high, or if you do not feel the way your results
indicate, repeat the test with a new test strip. If your
reading is not consistent with your symptoms or if your
blood glucose result is less than 60 mg/dL (3.3 mmol/
L) or higher than 240 mg/dL (13.3 mmol/L), you should
contact your healthcare professional and follow his or
her treatment advice.
Limitations
The Easy•Touch® Glucose Test Strips give accurate results
when the following limitations are observed:
1. Use only the Easy•Touch® Glucose Test Strips with the
Easy•Touch® Blood Glucose Meter.
2. Use only capillary whole blood from finger, palm and
forearm. Do not use plasma or serum.
3. Do not use neonate samples. Easy•Touch® Glucose
Test Strips are not validated for and should not be used
for testing neonatal blood specimens.
4. The system is tested to accurately read the measurement
of glucose in whole blood within the range of 20 to
600mg/dL (1.1-33.3 mmol/L).
5. This system can be used up to an altitude of 7545 feet.
6. The test strips are for single use only. Do not reuse test
strips.
Additional Information for Healthcare Professionals
7. E
asy•Touch® Glucose Test Strip does not interfere
with the hematocrit at a normal range (35-55%) of
blood glucose.
8. Acetaminophen, uric acid, ascorbic acid (vitamin C),
and other reducing substances when occurring in normal
blood or normal therapeutic concentrations do not
significantly affect results. However, abnormally
high concentrations in blood may cause inaccurately
high results.
9. Lipemic samples; Cholesterol up to 375 mg/dL or
triglycerides up to 2,000 mg/dL do not significantly affect
test results. However, glucose values in specimens
beyond these levels, should be interpreted with caution.
10. Blood samples that contain a high concentration of
dissolved oxygen may lower the test result.
11. Antiglycolysis and anticoagulants in blood samples may
affect the test results.
12. Severe dehydration, diabetic ketoacidosis,
hyperosmolar non-kitotic state, hypotension, shock, or
peripheral vascular disease.3,4,5 may cause inaccurate
results.
13. Critically ill patients should not be tested with home
use blood glucose monitors as it may lead to
inaccurate results.
Quality Control
Easy•Touch® Control Solution can be used to verify that
the Easy•Touch® Glucose Monitoring system is working
correctly and giving accurate results. The system is
performing correctly if the control solution test result falls
within the specific control solution range listed on your
Test Strip vial.
You are encouraged to use Control Solution on a
regular basis.
If you suspect your blood glucose test are not consistent
with how you feel or your test are higher or lower than
normal, you may validate the performance of your test with
Control Solution.
When a control solution test is done, you should get results
within the expected range printed on the test strip vial.
If control solution test results fall outside this range,
repeat the test. Results that fall outside the range may
be caused by:
• error in performing the test,
• expired or contaminated control solution,
• test strip deterioration or meter malfunction.
If the problem persists, the system may not be working
properly. DO NOT continue to use the system to test your
blood glucose level. If you continue to get results that fall
outside the specified range, please call Customer Service.
Note: Easy•Touch® Control Solutions are required but not
supplied with Test Strips for checking the system. For order
information, please contact Customer Service.
There are three Easy•Touch® Control Solutions at different
desired range of aqueous glucose (Low, Normal or High).
Two sets of control solution should be used, a high level
and a low level control solution of your choice. For more
information about the Control Solution, please read your
Control Solution package insert.
Performance Characteristics
Measuring Range
20-600mg/dL (1.1mmol/L to 33.3 mmol/L)
Accuracy
The accuracy of the Easy•Touch® Blood Glucose Monitoring
System was compared with YSI 2300 Stat Plus glucose
analyzer with fingertip testing done by persons with
diabetes. The linear regression statistics are derived from
a plot of the Easy•Touch® capillary data (y) versus YSI
glucose analyzer (x). The linear regression equation for
the study was y=0.98x-0.52. The coefficient was 0.9789.
The sample numbers were 112. The glucose range of the
sample was 56-429mg/dL.
Fingertip results
For glucose results lower than 75mg/dL, the
percent (and the number) of meter results that
match the laboratory method within 15 mg/dL
100%
(12 / 12)
For glucose results at or higher than 75mg/dL,
the percent (and the number) of meter results
that match the laboratory method within 20%
98%
(98 / 100)
Total number of patients in the study
98%
(110 / 112)
Alternate site testing results
Palm
Forearm
For glucose results lower than 75mg/
100%
100%
dL, the percent (and the number)
(12 / 12)
of meter results that match the (12 / 12)
laboratory method within 15 mg/dL
For glucose results at or higher
than 75mg/dL, the percent (and the
99%
97%
number) of meter results that match (98 / 99) (96 / 99)
the laboratory method within 20%
99%
97%
Total number of patients in the study
(110 / 111) (108 / 111)
Precision
Between-run precision of Easy•Touch® Glucose Test Strips,
are measured with venous blood samples in the laboratory.
The pooled precision data for three hundred test strips from
3 lots (n=300) is shown in the tables below:
Between-Run Precision
Average Glucose
Concentration (mg/dL)
37.7 90.0 130 224 353
SD (mg/dL)
1.8
2.8
4.1
5.4
7.6
CV (%)
4.7
3.2
3.3
2.4
2.1
Chemical Composition
Glucose oxidase (Aspergillus niger)
Potassium ferricyanide
Non-reactive ingredients
1.4% w/w
2.6% w/w
96% w/w
References
1. B
urtis CA Ashwood ER, eds.: Tietz Textbook of Clinical
Chemistry. 2nd Edition. W.B. Saunders. Philadelphia.
1994. p. 2190.
2. American Diabetes Association Clinical Practice
Recommendations 2003, Diabetes Care, Vol.26,
Supplement 1, p.S22.
3. Atkins SH, Dasmahapatra A, Jaker MA, Chorost MI,
Reddy S: Fingerstick glucose determination in shock.
Ann Int Med 114:1020-1024. 1991
4. Sandler M, Low-Beer T: Misleading capillary glucose
measurements. Practical Diabetes 7: 210. 1990
5. Wickham NWR, Achar KN, Cove DH: Unrealiability of
capillary blood glucose in peripheral vascular disease.
Practical Diabetes 3: 100.1986.
For in vitro Diagnostic use only.
Made in Taiwan to Specifications of:
MHC Medical Products, LLC
8695 Seward Rd.
Fairfield, OH 45011
Questions or Comments?
Call 1.877.358.4342
info@EasyTouchProducts.com
B04Q101099(01)
DH-080411.6
Rev. date: 09/2011