Intended Use; Test Principle - Fora D40 Pro Manual Del Propietário

Intended Use

The FORA D40 Pro Blood Glucose Plus Blood Pressure Monitoring
System is intended for use in the quantitative measurement of glucose
in fresh capillary whole blood from the finger and the following
alternative sites: palm, forearm or upper-arm. This system is intended
for multiple-patient use in professional healthcare settings as an aid to
monitor the effectiveness of diabetes control. This system is only used
with single-use auto-disabling lancing devices.
The system should not be used for the diagnosis of or screening for
diabetes, nor for neonatal use. Alternative site testing such as the palm,
forearm, and upper arm should be done only during steady – state
times (when glucose is not changing rapidly).
This system is also intended to be used to measure non-invasively the
systolic and diastolic blood pressure and pulse rate of an adult
individual. The blood pressure is measured by using an inflatable cuff
wrapped around the arm.

Test Principle

Your system measures the amount of sugar (glucose) in whole blood.
The glucose testing is based on the measurement of electrical current
generated by the reaction of glucose with the reagent of the strip. The
meter measures the current, calculates the blood glucose level, and
displays the result. The strength of the current produced by the reaction
depends on the amount of glucose in the blood sample.
The blood pressure is measured non-invasively at the arm based on the
Oscillometric method.
This device is NOT able to take measurements in the presence of
common arrhythmia, such as atrial or ventricular premature beats or
atrial fibrillation. It may produce reading errors.
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