EKOM ASPINA DO M, User Manual

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TECHNICAL DATA
NP-DO M-39_12-2021 16 12/2021
Guidance and manufacturer's declaration - electromagnetic immunity
Pursuant to IEC 60601-1-2:2014 - 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.
Immunity test
IEC 60601-1-2
test level
Compliance
level
Electromagnetic environment -
guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
Proximity fields
from RF wireless
communications
equipment
IEC 61000-4-3
3 Vrms
150 kHz to 80MHz
3 V/m
80 MHz to 2,7
GHz
9 to 28 V/m
15 specific
frequencies
(380 to 5800
MHz)
3 Vrms
3 V/m
9 to 28 V/m
15 specific
frequencies
(380 to 5800
MHz) 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 , 80 MHz to 800 MHz
d=
2,3√
P , 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 dis-
tance in metres (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey
a
, should be less than the
compliance level in each frequency range
b
. Interference may occur in the vicinity of
equipment marked with the following
symbol:
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.