Introduction To The System; Intended Use; Principle Of Measurement - Fora D15 User Manual

INTRODUCTION TO THE SYSTEM

Intended Use

The FORA D15 Blood Glucose plus Blood Pressure Monitoring
System is intended for the quantitative measurement of glucose in
fresh capillary whole blood (from the finger, the palm, the forearm,
the upper-arm, the calf and the thigh) for self testing by persons with
diabetes in the home or by healthcare professionals in healthcare
facilities. The system is also intended to be used to measure
non-invasively the systolic and diastolic blood pressure and pulse
rate of an adult individual over age 16, at home.

Principle of Measurement

Blood glucose is based on the measurement of electrical current
generated by the reaction of glucose with the reagent of the strip.
The monitor 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.
Blood pressure is measured non-invasively at the arm based on the
Oscillometric method.
Both functions work independent of each other (one measurement,
either blood glucose or blood pressure, at a time) in order to avoid
any interference problems.
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