
45
TRUSCULPT OPERATOR MANUAL
D1395, REV. K, 02/18
Guidance and Manufacturer’s Declaration: Electromagnetic Immunity
The truSculpt system is intended for use in the electromagnetic environment specified below. The customer or
the user of the truSculpt system 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
150kHz to 80 MHz
3V/m
80MHz 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 truSculpt system, including its
cables, than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
Recommended Separation Distance
d = 1.17
√
P
d = 1.17
√
P 80MHz to 800MHz
d = 2.33
√
P 800MHz to 2.5GHz
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 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 mobiles 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
truSculpt system is used exceeds the applicable RF compliance level above, the truSculpt system should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the truSculpt system.
(b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
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