Operating Principle; Contraindications For Use; Adverse Effects; Section 2: Safety Guidance - AngelSounds JPD-100S (mini) Instrucciones

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
fetal systole and diastole. Once cardiac valves vibrate and a Doppler
frequency excursion is formed. It is transmitted an output signal of
cardiac valves vibrating, and it is sent to signal demodulate unit to get
the Doppler frequency signal, and process the signal become the signal
that can be heard by human using headset.

1.5 Contraindications for Use

Normally none, as a particular case, please consult your doctor.

1.6 Adverse effects

No adverse effect.

Section 2: Safety Guidance

This product is internal powered equipment, and the degree of shock
protection is B applied part.
It means that these person connections will comply with permitted
leakage currents, dielectric strengths of IEC/EN60601.
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