Prodigy 52200 Instruction Manual

NO CODING REQUIRED TEST STRIPS
52200, 52800, 52870, 52970, 72500, 990250, 52825, 52835, 52810,
80810, 74600, 51800
CODING REQUIRED TEST STRIPS
52400
Patient Cautions:
❖ For in-vitro diagnostic use (external use only).
❖ Healthcare professionals and others using this system on multiple patients
should be aware that all products or objects that come into contact with
human blood should be handled as if capable of transmitting viral diseases,
even after cleaning.
❖ Please review this instruction sheet and the blood glucose meter owner's
manual before you use PRODIGY ® test strips. For reliable results and to
maintain the manufacturer's complete service, support and warranty, use
PRODIGY ® test strips only.
Critically ill patients should not use a blood glucose meter for monitoring their glucose
levels. Consult your healthcare professional.
INTENDED USE
PRODIGY test strips are intended for PRODIGY blood glucose meters, to measure
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concentration of blood glucose by self-testing for both professional and home use.
Routine blood glucose (sugar) testing with PRODIGY blood glucose monitoring system
®
can provide you and your healthcare professional information on how your treatment of
programs affects your blood glucose level. Blood glucose management should be done
in conjunction with advice from your qualified healthcare professional.
STORAGE AND HANDLING
In order to ensure that your test strips are effective, please use them according to the
following recommendations.
Important: Do not use the test strips after the expired date or results will be inaccurate.
To keep your test strips in the best possible condition, read the following
recommendations thoroughly:
❖ Write the expiration date on the test strip vial when first opening. Test strips
expire 90 days after opening.
❖ Store the test strips in a cool, dry place between 39°–104°F (4°–40°C)
and below 85 % relative humidity. Keep the test strips away from direct
sunlight.
❖ Test strips must be stored in their original vial ONLY. Do not transfer them to
a new vial or other container.
❖ Do not touch the test strips when your hands are wet.
❖ Use each strip promptly after removing it from the vial. Close the vial lid
quickly after removing a new strip.
❖ Keep the vial lid closed at all times.
❖ Do not bend, cut or alter the test strip. Doing so will lead to inaccurate
results.
HOW IT WORKS
PRODIGY test strips provide a quantitative measurement of glucose in whole blood. The
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blood is drawn into the absorbent channel of the test strip through capillary action and
the blood glucose level is measured by the meter. Results are displayed on the glucose
meter. Only 0.7 µL of blood is required and the reaction time is 7 seconds. PRODIGY
test strips detect glucose levels from 20 to 600 mg/dL or 1.1 to 33.3 mmol/L.
CODING REQUIRED TEST STRIPS
When using the system for the first time or before using a new vial of test strips, you will
need calibration, which can be easily done by selecting the correct code from the meter.
It's important to make sure that the LCD displayed code is the same as the code on
the test strip vial before you proceed. Only test blood glucose when the code matches
with each other.
Calibration is started by inserting a test strip into the meter.
The code number is then displayed and flashed on the LCD screen. Please complete the
following procedures for calibration:
1. Verify if the flashing code number is the same as the code on the test strip vial.
If yes, calibration is complete and you can directly start blood glucose test. If not,
please go to step 2.
2. While the number is flashing, press the code button to advance one number.
3. When you come to the correct code number, press the main button to set the
code.
4. You are able to start blood glucose testing or control solution measurement.
FOR ACCURATE RESULTS
Test strips should be used with a fresh blood sample. For best results it is recommended
that you read the following procedure and the glucose meter owner's manual before you
obtain a blood sample. To get a drop of blood, follow these steps:
1. Wash your hands and the puncture site. Rinse and dry yourself thoroughly. If
you use an alcohol swab, ensure that the puncture site is completely dry prior to
obtaining a sample.
2. Lance the puncture site to obtain a drop of blood. You may massage or gently
rub the area in order to obtain the required amount of blood. Do not squeeze the
puncture site excessively.
Important: Different testing sites may lead to different results. You may also obtain a
blood sample from your forearm, upper arm, calf or thigh. To obtain accurate results,
especially if you suffer from hypoglycemia, it is highly recommended that you use
fingertip testing. Please read the blood glucose meter owner's manual for important
information about testing sites and consult your healthcare professional before you
begin testing with a blood sample obtained from the arm or other parts of the body.
NO CODING REQUIRED TEST STRIPS
No calibration needed. Simply insert test strip and proceed to the next section.
CONTROL SOLUTION TESTING
Performing Control Solution Tests:
• When you begin using a new vial of test strips
• At least once a week
• Whenever you suspect that the meter or test strips are not working properly
• When your blood glucose test results are not consistent with how you feel, or
when you think your results are not accurate
• If you drop the meter
• When you change the batteries
PRODIGY ® Control Solution is used to check testing technique and system performance.
PRODIGY Blood Glucose Monitoring System uses both high and low control solution.
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When the control solution result falls within the control range given for the lot of test
strips being used, the system is working as it should, and your testing technique is good.
The control range can be found on the test strip vial label. Read glucose meter owner's
manual for complete testing details.
Important: For coded test strips, the control range can change with each new vial of test
strips. Always use control solution range on the label of your current vial of test strips.
BLOOD GLUCOSE TESTING
1. Fully insert the test strip into the meter with the contact bars end first. When the
strip will go no further, the meter will perform several self-checks.
2. Obtain a blood sample of at least 0.7 µL of blood. Hold the blood drop to
the absorbent channel of the test strip until blood has completely filled the
confirmation window. The meter will begin to count down.
3. After 7 seconds, the test results will appear, showing you the blood glucose test
result. The last reading is automatically stored in the meter memory. Shut the
meter off by removing the strip. Discard the used strip.
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Test Results:
Your blood glucose test results are displayed either in milligrams per deciliter (mg/dL) or
in millimoles per liter (mmol/L).
The meter is able to display test results from 20 to 600 mg/dL or from 1.1 to 33.3
mmol/L. If your test result is below the minimum value, repeat your test with a new
strip to confirm this reading. This indicates very low blood glucose levels or severe
hypoglycemia. You should immediately consult your healthcare professional.
If your test result is above the maximum value, repeat your test with a new strip
to confirm this reading. This indicates very high blood glucose levels, or severe
hyperglycemia. You should immediately consult your healthcare professional.
Reference values: Please consult your physician to establish your target ranges. The
American Diabetes Association (ADA) recommends that you keep your blood sugar
levels at:
Time of Day
Before Meals 70-130 mg/dL/ 3.8-7.2 mmol/L
1–2 Hours After Meal Less than 180 mg/dL/ 10 mmol/L
Source: American Diabetes Association (2008. Standards of medical care in diabetes.
Clinical Practice Recommendations 2008. Diabetes Care, 28 (Suppl): S4-S36.
Questionable or Inconsistent Results:
If you are receiving test results that are unusual or inconsistent with how you are feeling:
• Make sure that the drop of blood completely fills the absorbent channel of the
test strip
• Confirm that the test strips are not past their expiration date
• Make sure your meter has been properly coded and for the coded strips, that the
code corresponds to the test strip vial you are using
• Check the performance of the meter and test strips using the control solution
High or low blood glucose levels can indicate a possibly serious medical condition.
If you continue to get results that are unusually high or low, consult your healthcare
professional.
Chemical components in sensor:
1. Glucose Oxidase (A. niger) 10% 3. Enzyme Protector 8%
2. Electron Shuttle 50% 4. Non- reactive ingredients 32%
TEST PRINCIPLE
The blood glucose test is based on the measurement of electrical current generated by
the reaction of glucose with the reagent of the test strip. The meter measures the current
and displays the corresponding blood glucose level. The strength of the current produced
by the reaction depends on the amount of glucose in the blood sample.
Limitations:
❖ Hematocrit: Below 20% or above 60% hematocrit levels can cause false results.
Please consult your healthcare professional if you do not know your hematocrit
level.
❖ Neonatal Use: The test strips should not be used for the testing of newborns.
❖ Metabolites: Reducing substances such as uric acid and ascorbic acid when
occurring in expected blood concentration, or acetaminophen, dopa, methyldopa,
L-dopa and tolbutamide occurring in expected blood concentration will not
affect results.
❖ Lipemic Effects: Elevated blood triglycerides up to 2000 mg/dL do not
significantly affect the results. However, the blood glucose test may be affected
beyond these levels.
❖ Do not use iodoacetic acid or fluoride as a preservative for blood specimens.
❖ Use only fresh capillary whole blood. Do not use serum or plasma.
❖ Altitude Effects: Test strips may be used at altitudes up to 10,742 feet (3,275 m)
without effecting test results.
PERFORMANCE CHARACTERISTICS
Accuracy: Within ± 15 mg/dL (0.83 mmol/L) at glucose concentration < 75 mg/dL (4.2
mmol/L) and within 20% glucose concentration ≥ 75 mg/dL
(4.2 mmol/L).
Precision: CVs(%) of intermediate precision and repeatability were less than 5%.
The device has been certified to meet the following standards:
98/79/EC,IEC 60601-1, IEC 61010-1, IEC 60601-1-2, IEC 61326 and ISO 15197
Please refer to the Prodigy owner's manual for more detailed directions and illustrations.
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Source: American Diabetes Association (2012). Checking Your Blood Glucose. Clinical
Practice Recommendations 2005. Diabetes Care, 28 (Suppl): S4-S36.
Prodigy Diabetes Care, LLC 1.800.366.5901
9300 Harris Corners Parkway, Suite 450
Charlotte, NC 28269
AR REP Advena Ltd; 33 Bridge Street,
EC REP
Hereford HR4 9DQ, UK
For Customer Care call: 1.800.243.2636
www.prodigymeter.com
©2012 Prodigy is a registered trademark of Prodigy Diabetes Care.
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All rights reserved. TSMI Rev.3 02/12
ADA Requirement