49
GB
Geratherm Medical AG
Fahrenheitstraße 1
98716 Geschwenda
Germany
www.geratherm.com
Annex
Guidance and manufacturer´s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environments listed below, and
should only be used in such environments:
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 device, including cables, than
the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance:
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to
80 MHz
3 Vrms
d= 1.2
√
P
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
3 V/m
d = 1.2
√
P
80 MHz to 800 MHz
d = 2.3
√
P
800 MHz to 2.5 GHz
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
fi
xed 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 ofequipment marked
with the following symbol:
NOTE 1:
At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2:
These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and re
fl
ection from structures,
objects and people.
Guidance and manufacturer´s declaration – electromagnetic immunity
a)
Field strengths from
fi
xed transmitters, such as base stations for radio (cellular/cord-
less) 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
fi
xed RF transmitters, an electromagnetic
site survey should be considered. If the measured
fi
eld strength in the location in
which the device is used exceeds the applicable RF compliance level above, the
device should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating
the device.
b)
Over the frequency range 150 kHz to 80 MHz,
fi
eld strengths should be less
than 3 V/m.
