Shenzhen Hailife Technology Co. Ltd. FD01B ユーザーズマニュアル
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Section 1:Instruction
1.1Intended Use
The Fetal Doppler is a hand-held, battery powered audio Doppler device used for detecting
the sound of the fetal heartbeat (SFH). FD-01B, the product with Bluetooth feature, can also
record the trend line of the fetal heart rate(FHR).
1.2 Product Description
The Fetal Doppler 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 Fetal Doppler 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”.
1.3 Operation principle
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 fetal systole and diastole. Once
cardiac valves vibrate and a Doppler frequency excursion is formed. It is transmitted an