Tests show that the CV* (%) for intermediate precision and intermediate repetition is less than 5 %.
Traceability of the glucose monitoring system:
The results of the glucose monitoring system were compared with parallel results obtained using a YSI 2300,
which is the manufacturer’s standard measurement device. The examination shows that the TD 3213 blood
glucose monitor compared favourably with the manufacturer’s standard method.
The device is certified according to the following standards.
Tel.: +49 (0)
36413096299
Manufacturer:
Taidoc Tech.Co. Taiwan
*) CV = coefficient of variation
Warning to patients:
> This product is only for use in in-vitro diagnostics (for external use only)
> Medical supervisors and any others who use this system on a number of patients should be aware that
all products or items that come into contact with human blood should, even after cleansing, be treated as
if they are capable of transmitting viral diseases.
> Before using the TD 4313 test strips, users should read through both this instruction sheet and the user
guide for the blood glucose monitor in their entirety. Use TD 4313 test strips only. This will ensure
reliable results.
Use of any other test strips may result in restricted access to customer service and user support and also affect
the validity of the manufacturer’s guarantee. Should you require further advice, please consult your medical
supervisor.
TD 4313 test strips are designed for use with blood glucose monitor TD 3213. They are intended for measurement
of blood glucose concentration by self-testing and are for both professional and home usage. Routine blood
glucose tests using blood glucose monitor TD 3213 will provide both you and your doctor with accurate information
about how your treatment programme is affecting your blood glucose level. Regular testing of your blood glucose
level can also help keep your diabetes under control. Blood glucose management should always be carried out in
consultation with your qualified medical specialist.
Intended Usage
TD 4313 test strips provide a quantitative measurement of the glucose contained in whole blood. Whenever the
suction hole comes into contact with a drop of blood, this is filled automatically by means of a simple capillary
effect. The blood is drawn to the suction hole and the glucose level is measured by the monitor. The results are
then displayed on the device. Only a small amount of blood is required. The reaction time is 10 seconds.
TD 4313 test strips measure glucose levels from 1.1 to 33.3 mmol/l or from 20 to 600 mg/dl.
How the Test Strips Work
Coding the monitor
Before you open a new packet of test strips, you need to code the blood glucose monitor:
1. Insert the code strip fully into the hole in the strip. The device will emit a single beep and the code number
should appear on the display. Check that the code number matches the one on the test strips container.
2. Remove the test strip. The device is now ready to take measurements of blood glucose or for measuring the test
solution.
Blood glucose tests:
1. Insert the test strip fully into the measuring device with the contact plate end first. The measuring device will
carry out several tests automatically as soon as the strip is fully inserted. The code number will appear after
two seconds. This code number should match the number specified on the container.
.
2. Take a blood sample for use with the test strip. To obtain accurate results, at least 1.5 micro litres of blood are
required. Keep the drop of blood at the suction hole of the test strip until the confirmation window is filled with
blood. The monitor will start to count down.
3. After ten seconds, the test results will appear. From these you can determine your blood glucose level. The last
measured value is saved automatically in the monitor’s memory. Switch off the measuring device by removing
the strip. Always dispose of used test strips and lancets carefully (in household waste using an airtight
container) in a way that will prevent injury to and infection of other parties. When using the device in a medical
environment, dispose of the test strip and lancet using a suitable container according to regulations for
potentially infectious materials.
For more detailed descriptions and illustrations concerning both procedures, please consult the user guide.
Preparation and Testing
Coding
Each packet of test strips contains a code strip for calibration and each code strip contains a certain number. When
the code strip is entered into the monitor, its parameters are read automatically and the code number appears on
the display. Before continuing, always check that the code displayed matches the one on the test strip container.
Taking samples
Always use the test strips with a fresh blood sample. Before taking a blood sample, we recommend you note the
following procedure and also read through the blood glucose monitor handbook for optimum results. Proceed
in the following way to obtain a drop of blood:
1. Start by washing your hands as well as the intended pricking area. Wash and dry both thoroughly. When
using alcohol swabs, ensure pricking point is completely dry before taking a sample.
2. To obtain a drop of blood, prick the appropriate point. You may in some cases need to massage or gently rub
the relevant area to obtain the required amount of blood. Do not press on the pricking area with force.
For Extra Precision
To ensure your test strips function to the maximum possible efficiency, always observe the correct procedures for
storage and handling.
Important:
Never use the test strips after the use-by date has expired. Use of test strips that have passed their
use-by date may lead to inaccuracies in measurement values.
To ensure your test strips remain in the best possible condition, note the following recommendations
carefully:
> After opening, write the use-by date for the test strip on the test strip container.
Test strips are no longer fit for use 90 days after the date of opening.
> Store the test strips in a dry, cool place away from heat between 39.2 and 104 °F (4 and 40 °C) at a relative
humidity between 50 % and 70 %. Keep the test strips away from direct sunlight. Do not store the test strips
in areas affected by high levels of moisture. Do not store the test strips in the refrigerator.
>
> When handling the test strips, always ensure your hands are completely dry.
> Once a test strip has been removed from the container, it should be used immediately. Always reseal the
container quickly after removing a new strip.
> Keep lid sealed at all times.
> Never bend, cut or modify the test strips as this will lead to inaccuracies in results.
Handling and Storage
IMPORTANT:
The testing range can change with each new container of test strips. Always use the test range
indicated on the label of the container you are currently using.
Test results:
Your blood glucose test results are shown in millimols of blood sugar per litre (mmol/l) or as milligrams of blood
sugar per decilitre blood (mg/dl).
The measuring device displays test results from 1.1 to 33.3 mmol/l or from 20 to 600 mg/dl. Whenever your
results fall below the minimum value, “LO” will appear on the monitor. Repeat the test with a new strip to confirm
this measurement value is correct. This indicates a very low level of blood glucose or serious hypoglycaemia. The
hypoglycaemia should be treated immediately and in accordance with the recommendations of your medical
supervisor.
If your results exceed the maximum value, “HI” will appear on the monitor. Repeat the test with a new strip to
confirm the measurement value is correct. This indicates a high level of blood glucose or serious hyperglycaemia.
Immediate medical help should be sought in such cases.
Reference values: Blood glucose before eating 3.9 - 6.1 mmol/l or 70 - 110 mg/dl. For information on which range
that applies to you, please consult your doctor.
Dubious or inconsistent results:
Should you obtain test results that are unusual or inconsistent with how you are feeling:
> Ensure the test area of the test strip is full with blood.
> Check the test strip has not exceeded its use-by date.
> Ensure the monitoring device has been coded correctly and the code corresponds to the container of test
strips you are using.
> Check the monitoring device and the test strip are both functioning correctly using the test solution.
In some circumstances a high or low level of blood glucose can indicate a serious medical condition.
If you continue to obtain results that are unusually high or low, seek the advice of your medical supervisor.
Chemical components in sensor:
5.
1. Glucose oxidase (A. niger) 10 %
2. Electron shuttle 50 %
3. Enzyme protection 8 %
4. Non-reactive components 32 %
Lid of container with molecule filter 3.0 g
Test Principle
The test is based on the measurement of electric current generated by glucose reacting with the reagent on the
strip. The monitor measures this current and displays the corresponding blood glucose level. The strength of
current generated by the reaction depends on the amount of blood sugar in the blood sample.
Restrictions:
> Haematocrit: Haematocrit levels below 20 % or above 60 % can lead to incorrect results. Please consult your
medical supervisor if you are not aware of your heamatocrit level.
> Use with new-born children: The test strips should not be used for tests with new-born children.
> Metabolites: Lowering agents such as uric acid and ascorbic acid that may occur in the expected blood
concentration, acetaminophen, dopa, methyldopa, L-dopa or tolbutamid do not affect results.
> Lipaemia effects: Heightened blood triglycerides up to 2000 mg/ml do not have any significant effect on
results. Levels above this may affect the blood sugar however.
> Never use iodine acetic acid or fluoride as preservatives for blood samples.
> Use fresh capillary whole blood only. Never use serum or plasma.
> Altitude effects: The test strips can be used at altitudes of up to 10,742 feet (3,275 m) without this having any
effect on test results.
Performance Indicators
Accuracy:
Whole blood glucose test results were compared with the YSI 2300 blood glucose analyser. At a
concentration < 75 mg/dl (4.2 mMol/l) 100 % of measurements were at ±15 mg/dl (0.83 mMol/l). At a sugar
concentration 75 mg/dl (4.2 mMol/l) 100 % of measurements were within 20 % of reference values. These
results show that the TD 3213 blood sugar monitor compares favourably with a laboratory system.
Precision:
98/97/EC, IEC 60601-1, IEC 61010-1, IEC 60601-1-2, IEC 61326 and ISO 15197
ibp
Service-Center
Sale and distribution:
Germany
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Am Weimarer Berg 6
Botzstraße 6
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ALWAYS store the test strips in their original container. Never transfer the test strips to another container.
IMORTANT:
Different pricking points can lead to different results. We recommend using finger tip tests to obtain
accurate results.
Caution:
For information on blood glucose measurement using other parts of the body, always consult your
doctor beforehand.
Quality Control (QC) tests
We recommend conducting QC tests:
> Whenever you start using a new test strips container.
> At least once a week.
> As soon as you suspect the monitor or the test strips are not functioning correctly.
> If your blood glucose test results do not correspond to how you are feeling or whenever you believe test
results are inaccurate.
> Whenever the measuring device is dropped.
A test solution is used for gauging the testing technique and the equipment performance. Blood glucose
monitoring system TD 3213 uses two glucose test levels (normal, high). If the glucose test result is within the test
range specified for the test strip packet used, the equipment is functioning correctly and your testing technique is
also good. The designated test range can be found on the test strips container label.
For more details regarding tests, please see the user guide.
0123
© by
ibp
innovative business promotion gmbh, Germany
Status: May 2006
TD 4313 Test Strips
Version 2.0 for blood glucose tests with capillary
whole blood
TD 4313 Test Strips
Version 2.0 for blood glucose tests with capillary
whole blood
For blood glucose monitor TD-3213
For blood glucose monitor TD-3213
