BeneVision N1 Patient Monitor Operator’s Manual B - 3
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 IEC60601 test level Compliance level Electromagnetic environment - guidance
Conducted
disturbances induced
by RF fields
IEC61000-4-6: 2013
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:
150k to 80 MHz
80 MHz to 80 0MHz
800 MHz to 2.7GHz
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 and
amateur radio bands
a
between 0,15 MHz
and 80 MHz
6 Vrms
Radiated RF EM fields
IEC61000-4-3:
2006+A1:2007+A2:20
10
10V/m
80 MHz to 2.7 GHz
10V/m
20V/m
80 MHz to 2.5 GHz
(IEC80601-2-30: 2013,
ISO80601-2-55: 2011,
ISO80601-2-56: 2009,
ISO80601-2-61: 2011)
20V/m
Proximity fields from
RF wireless
communications
equipment
IEC61000-4-3:
2006+A1:2007+A2:20
10
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.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
a
The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 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.
b
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) 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 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 re-orienting or relocating the device.
c
Over the frequency ranges 150 kHz to 80 MHz, field strengths should be less than 3V/m.
Recommended Separation Distances between Portable and Mobile RF, Communications Equipment and This
Equipment
The equipment is intended for use in an electromagnetic environment in which radiated RF disturbance are controlled. The
customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and the device as recommended below,
according to the maximum output power of the communication equipment.
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