55
Instructions For Use
EN
Guidance and Manufacturer’s declaration - electromagnetic immunity
The FTS-3 Fetal Telemetry System is intended for use in the electromagnetic environment specified below. The
customer or the user of FTS-3 Fetal Telemetry System should assure that it is used in such an environment.
Immunity
Test
IEC 60601 test level
Compliance
level
Electromagnetic Environment - guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the FTS-3
Fetal Telemetry System including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
6Vrms
c
in ISM
bands between 0,15
MHz and 80 MHz
3Vrms
6Vrms
c
in ISM
bands between
0,15 MHz
and 80 MHz
d
= 1.2
√
P
150 KHz to 80 MHz
Radiated RF
IEC 61000-4-3
3 V/m
80MHz to 2.5GHz
3V/m
d
= 1.2
√
P
80MHz to 800MHz
d
= 2.3
√
P
800MHz to 2.5GHz
d √ 6 P / E 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:
NOTE 1 At 80MHz and 800MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/wireless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which the FTS-3 Fetal Telemetry
System is used exceeds the applicable RF compliance level above, FTS-3 Fetal Telemetry System should
be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating FTS-3 Fetal Telemetry System.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
c
The ISM (industrial, scientific and medical) bands between 0.15 MHz and 80 MHz are 6.765 MHz to6.795
MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. The amateur
radio bands between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz to 5.4
MHz, 7 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz,21.0 MHz to
21.4 MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0 MHz.
