F-4
Guidance and Manufacturer's Declaration
Table F-5 Electromagnetic Immunity (RF Radiated and Conducted)
Immunity Test
IEC 60601-1-2
Test Level
Compliance Level Electromagnetic Environment - Guidance
The EV1000 Clinical Platform NI is intended for use in the electromagnetic environment specified below. The customer or user of
the EV1000 Clinical Platform NI should assure that it is used in such an environment.
Conducted RF
IEC 61000-4-6
Radiated RF IEC
61000-4-3
3 Vms150 kHz to 80
MHz
3 V/m80 to 2500
MHz
3 Vrms
3 V/m
Portable and mobile RF communication equipment should be
used no closer to any part of the EV1000 platform, including
cables, than the recommended separation distance calculated
from the equation applicable to the frequency of the transmitter.
Recommended Separation Distance
d = [1.2] x ; 150 kHz to 80 MHz
d = [1.2] x ; 80 MHz to 800 MHz
d = [2.3] x ; 800 MHz to 2500 MHz
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,
a
should be less than the compliance
level in each frequency range.
b
Interference may occur in the vicinity of equipment with the
following symbol:
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 EV1000 Clinical Platform NI is used exceeds the applicable RF compliance level above, the EV1000 Clinical Platform NI should
be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting
or relocating the EV1000 Clinical Platform NI.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 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.
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