2
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 the loudspeaker for getting a
rhythmical sound with the fetal heartbeat.
SECTION 2: SAFETY GUIDANCE
2.1 INDICATIONS FOR USE
The product is normally applied to fetus above 9~12 weeks growth,
difference in pregnant mater.
Listen to SFH:
Operator can listen to the sound of fetal heartbeat from the
headset.
Audio record:
The sound of fetal heartbeat can be recorded by a recorder
which is connected with the product.
As a safety advisement that can only be connected with a
recorder complied with the safety requirements of IEC
60601-1.
2.2 CONTRAINDICATIONS FOR USE
Normally none, as a particular case, please consult your doctor.
2.3 NOTE FOR HOME USE
Please consult your doctor.
2.4 SAFETY TERMS AND CONDITIONS
The signal words shown below, left, identify the potential hazard
categories. The definition of each category is as follows:
19
Appendix A: EMC Information-Guidance and Manufacture
’
s
Declaration
CAUTION:
Fetal Heart Detector
needs special precautions regarding EMC
and needs to be installed and put into service according to the
EMC information provided for in the ACCOMPANYING
DOCUMENTS.
Portable and mobile RF communications equipment can affect
Fetal Heart Detector
.
The
Fetal Heart Detector
should not be used adjacent to or
stacked with other equipment.
The
Fetal Heart Detector
is intended for use in the electromagnetic
environment specified below. The customer or the user of the Fetal heart
monitor should assure that it is used in such an environment.
Emissions
test
Compliance
RF
emissions
CISPR 11
Group 1
The
Fetal Heart Detector
uses RF energy
only for its internal function. Therefore, its
RF emissions are very low, and are not
likely to cause any interference in nearby
electronic equipment.
RF
emissions
CISPR 11
Class B
The
Fetal Heart Detector
is suitable for use
in all establishments, including domestic
establishments
and
those
directly
connected to the public low-voltage power
supply network that supplies buildings used
for domestic purposes.
The
Fetal Heart Detector
is intended for use in the electromagnetic
environment specified below. The customer or the user of the Fetal Heart
Detector should assure that it is used in such an environment.
Immunity test
IEC
60601
test level
Compliance
level
Electromagnetic
environment guidance
Electrostatic
discharge
(ESD)
±
6 kV
contact
±
8 kV
±
6 kV
contact
±
8 kV air
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
