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Annex 2. Electromagnetic Emissions and Immunity
27
Guidance and manufacturer’s declaration – noise immunity
The system is intended for operation in electromagnetic conditions environment described below. The
customer or user of the system should provide the system operation in the specified electromagnetic
conditions environment.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic environment
–
guidance
Portable and mobile RF communica-
tions equipment should be used no
closer to any part of the system,
including
cables,
than
the
recommended
separation
distance
calculated from the equation applicable
to the frequency of the transmitter. The
recommended separation distance:
Conducted RF
IEC 61000-4-6:2013
3 V in 0,15 MHz-80 MHz
band; 6 V in ISM band
between 0,15 MHz and
80 MHz; 80% AM
at 1 kHz
1)
3 V
3)
P
d
17
.
1
Radiated RF
IEC 61000-4-3:2006
10 V/m
80 MHz
– 2,7 GHz;
80% A
М at 1 kHz
3 V/m in 80 MHz -
2.7 GHz band, 80% AM
at 1 kHz
10 V/m
P
d
17
.
1
(80 MHz to 800 MHz);
P
d
33
.
2
(800 MHz to 2.7 GHz),
Field
strengths
from
fixed
RF
transmitters, as determined by an
electromagnetic site survey
1)
, should be
less than the compliance level in each
frequency range
2)
. Interference may
occur in the vicinity of equipment
marked with the following symbol:
Radiated RF wireless
communication
equipment
IEC 61000-4-3:2006
Band (MHz)
Immunity
level (V/m)
The use of portable and mobile RF
communications
equipment
can
adversely affect the recording; do not
use an operating cellular phone within
30 cm (12 inches) of the system, the
cables and the electrodes to avoid
excessive noise on the signals.
380-390
27
27 V/m
430-470
28
28 V/m
704-787
9
9 V/m
80-960
28
28 V/m
1700-1990
28
28 V/m
2400-2470
28
28 V/m
5100-5800
9
9 V/m
1)
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
system is used exceeds the applicable RF compliance level above, the system should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as
re-orienting or relocating the system.
2)
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
3)
Ensured by PC compliance with IEC 61000-4-6 requirements.
Notes:
1. At 80 MHz and 800 MHz, the higher frequency range is applied.
2. These guidelines are not applied in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.