EDAN F15 Series User Manual

F15 Series Fetal & Maternal Monitor User Manual EMC Information
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A7.3 Electromagnetic Immunity
Guidance and manufacture’s declaration – electromagnetic immunity
The F15 Series Fetal & Maternal Monitors are intended for use in the electromagnetic environment
specified below. The customer or the user of F15 Series Express Fetal & Maternal Monitors should
assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance
level
Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
6Vrmsc)in ISM bands
between
0,15 MHz and 80 MHz
3 V/m
80 MHz to 2.7 GHz
3Vrms
6Vrmsc)in
ISM bands
between
0,15 MHz
and 80 MHz
3 V/m
80 MHz to
2.7 GHz
Portable and mobile RF communications
equipment should be used no closer to any
part of the F15 Series Fetal & Maternal
Monitors including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter.
Recommended separation distance
Pd 2.1
150 kHz to 80 MHz
Pd 2.1
80 MHz to 800 MHz
Pd 3.2
800 MHz to 2.7 GHz
E/6 Pd 
at RF wireless communications
equipment bands (Portable RF
communications equipment (including
peripherals such as antenna cables and
external antennas) should be used no closer
than 30 cm (12 inches) to any part of the
monitor, including cables specified by the
manufacturer).
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 meters
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site
survey,
a)
should be less than the compliance
level in each frequency range.
b)
Interference may occur in the vicinity of
equipment marked with the following symbol:
Traditional 510(k) of Fetal & Maternal Monitor
014_14.1_F15_Series_User_Manual
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EDAN F15 Series Specifications

General

Brand	EDAN
Model	F15 Series
Category	Monitor
Language	English