20
IEC
61000-4-2
air
synthetic
material,
the
relative humidity should be
at least 30 %.
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
Complia
nce
level
Electromagnetic environment
–
guidance
Radiated
RF
IEC
61000-4-3
3 V/m
80 MHz
to 2,5
GHz
3 V/m
Portable
and
mobile
RF
communications equipment should
be used no closer to any part of the
Fetal Heart Detector
including
cables, than the recommended
separation distance calculated from
the equation applicable to the
frequency
of
the
transmitter.
Recommended separation distance
a. Where P is the maximum output
power rating of the transmitter in
watts
(W)
according
to
the
transmitter manufacturer and d is
the
recommended
separation
distance in metres (m). Field
strengths
from
fixed
RF
transmitters, as determined by an
1
SECTION 1: INTRODUCTION
1.1 OVERVIEW
Become familiar with the controls and how to use the product properly
before operating the product.
CAUTION:
It should not be used in life supporting or life
sustaining applications.
1.2 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 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
gynecology 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 an internal battery.
1.3 OPERATING PRINCIPLE
Fetal Heart Detector consists of probe (transmitter and receiver) and
signal process unit.
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
