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Chapter 1 OMRON Blood Glucose Monitoring
System HEA-232
1.1 Introduction
The HEA-232 uses state-of-art bioelectrochemistry detecting
technology; it needs approximately 1μL of fresh capillary whole
blood for one test. The blood glucose concentration is displayed in 5
seconds after the blood has been applied to the test zone. The device
is intended for use by diabetics to monitor their own glucose levels.
Please read the instruction manual carefully before using. Hea-232 is
an in vitro diagnostic medical device for self-testing. Capillary action
automatically lls the reaction zone with the test sample from the front
channel. The device should not be used for screening or diagnosis of
diabetes or for testing on neonates.
Intended Use
The HEA-232 is an in-vitro diagnostic medical device intended for the
quantitative measurement of glucose in fresh capillary whole blood
samples drawn from the ngertips. Testing is done outside the body.
It is designed for self-testing to monitor the effectiveness of diabetes
control. The device should not be used for screening or diagnosis of
diabetes or for testing neonates.
Principle of the method
The auto-filling process precisely controls the sample volume. The
blood glucose test strip is a kind of electrochemical sensor. When the
blood sample reacts with the strip, the glucose meter displays a reading
that depends on the number of electrons detected as a result of the
reaction.
The current generated by the reaction on the test strip is used to
calculate the glucose concentration of the sample which is then
displayed by the device.
Warning: The Glucose Results provided by HEA-232 is only for
reference; never make significant changes in your diabetes
treatment program without consulting a
doctor.
Warning: Evaluations using the HEA-232 by lay persons in
different countries will depend on their uency, or otherwise, in the
understanding and the assessment of ease of use and interpretation
of the results.
Measuring principle
Amperometric biosensors are quite sensitive and more suited for mass
production. The working electrode of the amperometric biosensor
is usually a screen-printed layer covered by the bio-recognition
component. The dried reagent was applied on a pair of carbon
electrodes. Glucose can be specically catalyzed by the enzyme, and
then the reaction current can be measured according to the glucose