1.2 Indication for Use
This device can detect the Fetal Heart Rate.Connect the headset allows
for hearing the sound of the fetal heartbeat. You can count the fetal
heart rate when listening. This device normally is applied to 16 weeks
gestation or later, difference in pregnant mater.
The device detects fetal life from early gestation thru delivery, and it can
be a general indication of fetal well being.
The normal range of fetal heart rate: 110bpm-160bpm.
1.3 Product Description
The product is a lightweight, portable detector. It is designed to meet
your detecting and hearing needs by providing advanced detecting
functions and a full range of sound of the fetal heartbeat.
The product is mainly used to detect the fetal heartbeat rate (FHR) and
the sound of the fetal heartbeat (SFH).
The growth and development of a fetus can be found out through
examination of these indices. It is applicable for department of
gynaecology and obstetrics and clinic daily.
In accordance with classification criteria in Annex IX on "Medical Device
Directive 93/42/EEC", the product is class IIa based on rule 10, "Devices
for Direct Diagnosis or Detection on physiological process".
The Product is powered by a 9V internal battery.
1.4 Operating Principle
Fetal Doppler consists of transmitter unit, receiver unit, signal process
unit, and signal output unit (such as headset).
Ultrasonic wave is transmitted from one piezoelectric ceramic at the
front of the probe to the uterus of the pregnant women. Echo is received
by the other piezoelectric ceramic at the front of the probe when
ultrasonic wave reaches the fatal heart. Then it is converted into voltage.
This doppler signal is detected and demodulated from the received
signal. And the Doppler frequency is consistent with the rhythm of the
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