B-4
Guidance and Declaration - Electromagnetic Immunity
The device is intended for use in the specified electromagnetic environment. The customer or the user of the
device should assure that it is used in such an environment as described below.
Immunity
test
IEC 60601 Test
level
Compliance
level Electromagnetic environment - guidance
Conducted
disturbances
induced by
RF fields
IEC61000-4-6
3 Vrms
150 kHz to 80
MHz
3 Vrms
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:
P
V
d
=
5.3
150k to 80 MHz
P
E
d
=
5.3
80 MHz to 800 MHz
P
E
d
=
7
800 MHz to 2.7 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 meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
b
,
should be less than the compliance level in each
frequency range
c
.
Interference may occur in the vicinity of
equipment marked with the following symbol:
.
6 Vrms
in ISM bands
a
between 0,15
MHz and 80 MHz
6 Vrms
6 Vrms
in ISM bands and
amateur radio
bands
a
between
0,15 MHz and 80
MHz
6 Vrms
(during patient
transport)
Radiated RF
EM fields
IEC61000-4-3
3V/m
80 MHz to 2.7 GHz
10V/m
10V/m
80 MHz to 2.7 GHz
10V/m
(during patient
transport)
20V/m
80 MHz to 2.5 GHz
(IEC80601-2-30,
ISO80601-2-56,
ISO80601-2-61)
20 V/m
(during patient
transport)
Proximity
fields from RF
wireless
communicati
ons
equipment
IEC61000-4-3
27 V/m
380–390 MHz
27 V/m
28 V/m
430–470 MHz,
800–960 MHz,
1700–1990 MHz,
2400–2570 MHz
28 V/m
9 V/m
704–787 MHz,
5100–5800 MHz
9 V/m
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
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