microdot®+ Test Strips
For use in Whole Blood
Please read these instructions and your microdot®+
User Manual before using microdot®+ Test Strips
For help call microdot®+ Customer Service.
umber s operated continually.
Intended Use
microdot®+ Test Strips are used to measure glucose (sugar) in
capillary whole blood outside of the body (in vitro diagnostic
use). Use microdot®+ Test Strips only with the microdot®+
Blood Glucose Test System. microdot®+ Test Strips are plasma
calibrated to allow easy comparison of results with laboratory
methods.
Storage and Handling
•
Store the strips in their original vial in a cool, dry place
between 50 ˚ and 86 ˚ F (10 ˚- 30˚ C). Keep away from
sunlight and heat.
•
Do not refrigerate or freeze.
•
When you take a strip from the vial, close the cap
immediately. Use the strip immediately.
•
Do not use microdot®+ Test Strips more than 6 months
after the vial is first opened. Write the discard date on the
vial when you first open it.
•
Check the expiry date on the vial. If the expiry date has
passed do not use the strips.
Test Materials
Provided in this package:
microdot®+ Test Strips
•
microdot®+ Test Strips Instructions
•
You will also need:
microdot®+ Blood Glucose Meter
•
microdot®+ User Manual
•
•
Lancing Device
•
Sterile Lancet
How to do the Test
Use microdot®+ Test Strips only with fresh capillary whole
blood or microdot® control solution.
1. Preparing to Test
•
Take a strip from the vial and put it into the meter.
Check that the black contact bars are facing the meter
and the test zone and letters are facing up. Close the
vial immediately.
•
Push the strip in firmly until it stops. You will see the
meter turn on automatically. The meter then checks
each item of information on its display.
•
You will then see the drop of blood symbol appear and
begin flashing. You can now apply the blood sample.
2. Getting a Blood Sample
To get a sample from your finger proceed as follows:
•
Wash your hands in warm, soapy water and dry well.
•
Lance your skin with the lancing device.
•
Squeeze gently until you get a rounded drop of blood.
The blood sample must be at least 0.6 microlitres (600
nanolitres) to get an accurate result.
3. Testing
•
While the drop of blood symbol is flashing, touch and hold
the top EDGE of the strip to the rounded drop of blood so it
meets the test zone. The strip draws the blood into the test
zone. Only apply blood while the drop of blood symbol is
•
•
•
flashing.
Do not use a smear or scrape blood into the strip.
Hold the blood drop to the top EDGE of the test strip until
blood has completely filled the test zone and the meter
beeps. The meter will then count down in seconds
10,9,8….2,1 on the display.
If the test zone does not fill up, stop the test and retest with
a new strip. If you continue to have trouble, call microdot®+
Customer Service for help.
4. Your Result
•
After 10 seconds the meter will beep, your glucose result
will be displayed on the meter display and then
automatically stored in the meter memory.
•
Turn the meter off by removing the strip by hand or ejecting
it as described below.
•
To eject the strip, hold the meter vertically above a safe
disposal bin with the strip pointing into the bin and push the
eject button.
What Do Your Results Mean?
Your blood glucose values will vary due to such things as diet,
time of day and what you are doing. Your healthcare
professional will help you to understand these variations. You
should set your own range of expected blood glucose values,
testing times, and discuss your blood glucose results with your
healthcare professional.
Expected fasting plasma glucose levels for people without
1
diabetes are less than 110mg/dL (6.1 mmol/L).
Test Units
Blood glucose test results are shown on the meter as either
milligrams of glucose per decilitre (mg/dL) or millimoles of
glucose per litre (mmol/L) depending on which units is set on
your meter.
Unexpected Results
Very high or very Iow blood glucose readings can indicate a
serious medical condition. Repeat the test if you see an
unusual reading. If these results are still unusual, or do not
match your symptoms, contact your health care
professional for advice.
Hi or Lo readings may indicate hyper or hypoglycemia and
should be treated immediately.
Checking Your System
A control solution is used to check the performance of the
microdot®+ system and your test technique. Run a quality
control check with microdot® Control Solution if your blood
sugar result seems unusually high or Iow unlike your previous
results, or is inconsistent with your symptoms. If the control
result is within the acceptable range, check your test method
and repeat your glucose test with a new strip. If the control
result is not within the acceptable range, call microdot®+
Customer Service. Only use microdot® Control Solutions with
microdot®+ Test Strips.
Some of the reasons for unusually high or Iow results:
•
Poor technique
•
Strip was used after expiry date.
•
Vial cap was not replaced and sealed.
•
Storage in too high or too Iow temperatures.
•
Strip was not used immediately after removing from
vial.
Whenever your blood glucose value is inconsistent with your
previous results, glucose trends or your symptoms, contact
your doctor. Follow the advice of your doctor before you change
your therapy.
Limitations
microdot®+ Test Strips give accurate results when the following
limitations are observed:
•
Use fresh whole capillary blood. Do not use plasma
or serum.
•
Use each test strip once. Do not reuse.
•
Do not bend, cut or damage the test strip.
•
Do not use for the testing of newborns.
•
Do not use during or after xylose absorption testing.
•
Very high haematocrit levels (above 55%) may cause
falsely Iow readings. Very Iow levels (below 25%) may
produce falsely high readings. Consult your healthcare
professional if you do not know your haematocrit level.
•
Vitamin C (ascorbic acid) does not significantly affect
results at normal levels or normal therapeutic levels.
Abnormally high vitamin C levels may produce falsely
high results.
•
Cholesterol levels up to 500 mg/dL (13 mmol/L) and
triglycerides up to 3000 mg/dL (34 mmol/L) do not
affect results. The microdot®+ Test Strips should not be
used with grossly lipemic samples with lipid levels
beyond these levels.
microdot®+ Test Strips may be used at altitudes up to
•
10,000 feet without an effect on test results.
microdot®+ Test Strips are designed for use at
•
temperatures between 50° and 104°F ( 10° C to 40°C)
and relative humidity between 10% and 90%.
•
Do not test critically ill patients with blood glucose
meters. The readings may be misleadingly low if the
patient is severely dehydrated, in shock, or in a
hyperosmolar state (with or without Ketosis).
•
Do not use this device in close proximity to sources of
strong electromagnetic radiation as these may interfere
with its proper operation.
Bloodav
296
16.4
(Bloodav is the average of the meter readings)
Total Precision
Control
Solution
45
117
371
2.5
6.5
20.6
5.42
4.96
4.89
This means that the strip to strip variation was not greater than
5.6%.
Test Principle
When blood is added to the microdot®+ strip, the chemicals
within the strip react to create a tiny electrical current. Your
meter reads the current and displays your level of blood
glucose.
Chemical Composition
Each microdot®+ strip contains the enzyme glucose
dehydrogenase (Bacillus Sp.) ≥ 1 IU and other ingredients
(mediator, NAD, lysing agents etc.) ≥ 200 µ g.
SEE USER MANUAL
CALL microdot®+ CUSTOMER SERVICE
Cambridge Sensors Limited
Cambridgeshire PE29 2X G | United Kingdom
www.microdot.biz
Packaging Symbols
Lot Number
Performance Characteristics
The performance of microdot®+ Test Strips has been evaluated
both in laboratory and in clinical tests.
Expiry Date
Range: The measurement range of the microdot®+ System is
20 to 525 mg/dL (1.1-29.2 mmoI/L).
For in vitro diagnostic use
Accuracy: The accuracy of the microdot®+ System was
assessed by comparing blood glucose results obtained by 102
patients at one clinical centre with those obtained using a YSI
2300 laboratory Instrument.
Clark error grid analysis: 98% A region; 2 % B region
Correlation coefficient R = 0.977
Range tested 45 to 472 mg/dL (2.5 to 26.2 mmol/L)
Slope 0.973 y-Intercept 3.96 mg/dL (0.22 mmol/L).
This means that the microdot®+ system compared well to a
laboratory method.
Precision:
Within-Run Precision (20 replicates in 1 day)was carried out
with spiked whole venous blood in the laboratory.
Glucose value
Bloodav
Bloodav
Bloodav
Bloodav
mg/dL
43
81
124
197
mmol/L CV(%)
2.4
4.5
6.9
10.9
5.61
4.07
3.27
3.55
3.31
Caution symbol: See Instructions for use
Manufactured by
Storage Temperature
Product fulfils the requirement of EC Directive
98/79/EC concerning in vitro diagnostic
medical devices.
Reference
1
Report of the Expert Committee on the Diagnosis and
Classification of Diabetes Mellitus. Diabetes Care
1997;20:1183-97.
LBL - 204 NL – 08D
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