IceCure Medical Ltd.
DSR3000000 rev.L
Confidential
User Manual
103
IceSense3™
Guidance and manufacturer’s declaration-electromagnetic immunity- for EQUIPMENT
and SYSTEM that are not LIFE-SUPPORTING
Guidance and manufacturer’s declaration-electromagnetic immunity
The model IceSense3 Cryotherapy product is intended for use in the electromagnetic environment
specified below. The customer or the user of the model IceSense3 Cryotherapy product should assure
that it is used in such an environment.
Immunity test
IEC 60601 test
level
Compliance
level
Electromagnetic environment- guidance
Conducted RF EN
61000-4-6
Radiated RF EN
61000-4-3
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2,5
GHz
3 V
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the model IceSense3 Cryotherapy
product, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
of the transmitter.
Recommended separation distance
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 metres
(m). b
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 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 model IceSense3 Cryotherapy product is used exceeds the applicable
RF compliance level above, The model IceSense3 Cryotherapy product should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the model
IceSense3 Cryotherapy product.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
