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Guidance and manufacturer's declaration - electromagnetic immunity
Pursuant to IEC 60601-1-2:2014/AMD1:2020 - Medical electrical equipment - Part 1-2: General
requirements for
basic safety and essential performance - Collateral Standard: Electromagnetic disturbances
The equipment is intended for use in the electromagnetic environment specified below. The customer or the
user of the equipment should assure that it is used in such an environment.
IEC 60601-1-2
Immunity test
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80MHz
Radiated RF
3 V/m
IEC 61000-4-3
80 MHz to 2,7 GHz
9 to 28 V/m
Proximity fields
15 specific
from RF wireless
frequencies
communications
(380 to 5800 MHz)
equipment
IEC 61000-4-3
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
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 equipment is used exceeds the applicable RF compliance
level above, the equipment should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or
relocating the equipment.
b
Over the frequency range 150 kHz to 80 kHz, field strengths should be less than 3 V/m.
NP-DK50 2V 50, 2x2V 110-AD-2_05-2022
Compliance level
test level
3 Vrms
3 V/m
9 to 28 V/m
15 specific
frequencies
(380 to 5800 MHz)
Electromagnetic environment - guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the equipment, including cables, than
the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
d=1,2√ P
d=1,2√ P
d=2,3√ P
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 dis-
tance in metres (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
a
survey
, should be less than the compliance
level in each frequency range
may occur in the vicinity of equipment
marked with the following symbol:
30
TECHNICAL DATA
, 80 MHz to 800 MHz
, 800 MHz to 2,7 GHz
b
. Interference
05/2022

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