Annex 3. Electromagnetic Emission and Immunity
49
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
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 kHz1)
3 V
3)
Portable and mobile RF
communications 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:
P
d
17
.
1
=
Radiated RF
IEC 61000-4-3:2006
10 V/m
80
М
Hz – 2,7 GHz
80 %
АМ
at 1
к
Hz
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.