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