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AUTOMATIC
47
Immunity test Test level
IEC/EN 60601-1
Compliance level Electromagnetic environment -
Guidelines
Supply frequency
(magnetic field)
50/60 Hz
IEC/EN 61000-4-8
3 A/m 80 A/m
Power frequency magnetic fields must be at levels no
higher than those of stations located in typical heavy
industrial applications, power plants and control
rooms of high voltage substations.
Note: U
T
is the main AC current before the test level is applied
RF conducted
3 Vrms Not applicable
IEC/EN 61000-4-6
from 150 kHz to 80 MHz
outside of ranges ISM
a
10 Vrms
from 150 kHz to 80 MHz
inside the ranges ISM
a
Not applicable
RF radiated
IEC/EN 61000-4-3
10 V/m
from 80 MHz to 2,5 GHz 10 V/m
The distance between portable and mobile RF
communications equipment in use and any part of the
AED, including cables, must never be less than the
recommended separation distance calculated based on
the equation applicable to the transmitter frequency.
Recommended separation distance
from 80 MHz to 800 MHz
from 800 MHZ to 2,5 GHz
Where P is the transmitter's maximum output power
range in watts (W) according to the transmitter
manufacturer's data and d is the recommended
distance in meters (m)
b
.
The field strengths of fixed radiofrequency
transmitters, as determined by an investigation in
electromagnetic sites,
c
should be less than the
compliance level in each frequency range.
d
Interference may occur near the devices marked with
this symbol.
NOTE 1
From 80 MHz to 800 MHz, the higher frequency range applies.
NOTE 1
These guidelines may not apply in all situations. Electromagnetic propagation is influenced by absorption and reflection from
structures, objects and people.
a
The ISM bands (industrial, scientific and medical) between 150 kHz and 80 MHz are from 6.765 MHz to 6.795 MHz; from 13.553
MHz to 13.567 MHz; from 26.957 MHz to 27.283 MHz; and from 40.66 to 40.70 MHz.
b
The levels of compliance in the ISM bands between 150 kHz and 80 MHz and between 80 MHz and 2.5 GHz are designed to
reduce the possibility of interference in the event that portable and mobile communication devices are inadvertently approached to
the area where the patient is found. For this reason, an additional factor of 10/3 is added to the calculation of the recommended
separation distance for transmitters whose frequencies fall within these ranges.
c
It is not possible to accurately predict theoretically the field strengths of fixed transmitters, such as base stations for radio (cellular /
cordless) telephones and mobile radios, amateur radio, AM and FM radio and TV. To assess the electromagnetic environment with
fixed RF transmitters, consider conducting an electromagnetic site survey. If the power of the fields measured in the location in
which the AED is used exceeds the specific RF compliance level mentioned above, it will be necessary to monitor the AED to
verify its correct functioning. If operating anomalies are observed, it may be necessary to take corrective measures, for example by
moving or reorienting the AED.
d Over the frequency range between 150 kHz and 80 MHz, field strengths must be less than 1 V / m.
P d 2 . 1

P d 3 . 2
