Ulthera Cellfina System System-Gebrauchsanweisung Seite 27

Ulthera, Inc.
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The CM1 Motor Module is intended for use in the electromagnetic environment specified
below. The customer or the user of the CM1 Motor Module should assure that it is used in
such an environment.
Immunity test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
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 CM1 Motor Module is used exceeds the applicable RF compliance level above,
the CM1 Motor Module should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the CM1 Motor
Module.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
1007270IFU Rev D
®
Cellfina
IEC 60601 test Compliance
level level
3 Vrms 3 Vrms
150 kHz to 80 150 kHz to 80
MHz MHz
3 V/m 3 V/m
80 MHz to 2,5 80 MHz to 2,5
GHz GHz
System
Electromagnetic environment –
guidance
Portable and mobile RF
communications equipment should
be used no closer to any part of the
CM1 Motor Module, 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 2.5 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
metres (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,
be less than the compliance level in
each frequency range.
Interference may occur in the vicinity
of equipment marked with the
following symbol:
User Manual
a
should
b
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