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30 Emitted Radiation & Electromagnetic Compatibility
Table 3 – Guidance and MANUFACTURER’S declaration – electromagnetic IMMUNITY – for ME
EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
Optune
®
Treatment Kit is intended for use in the electromagnetic environment specified below. The customer or
the user of Optune Treatment Kit should ensure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance
Conducted RF IEC
61000-4-6
Radiated RF IEC
61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2,5 GHz
3 Vrms
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any part
of Optune Treatment Kit including cables, than
the recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance
80 MHz to 800 MHz
800 MHz to 2,5 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 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 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 aected 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 Optune Treatment Kit is used exceeds
the applicable RF compliance level above, Optune Treatment Kit should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating
Optune Treatment Kit
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m
Emitted Radiation & Electromagnetic Compatibility
d =1,21√P
d =1,21√P
d =1,21√P
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