Ulthera DeepSEE DS 4 - 4.5, Instructions For Use Manual

Page: 28 / 72

Page
28
Ulthera, Inc.
NOTE 1: Ur is the AC mains voltage prior to application of the test level.
NOTE 2: System interruption may result in a safe restart classified as a nuisance.
Table 4.7 Electromagnetic Immunity Continued
IMMUNITY TEST IEC 60601
TEST LEVEL
COMPLIANCE
LEVEL
ELECTROMAGNETIC
ENVIRONMENT - GUIDANCE
Portable and mobile RF communications equipment should
be used no closer to any part of the Ulthera system, Including
cables, than the recommended separation distance
calculated from the equation applicable to the frequency of
the transmitter.
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to
80 MHz
3 Vrms
150 kHz to 80
MHz
Recommended separation
distance:
d =0.35 √ P
d =0.35 √ P
( 80 MHz to 800 MHz)
d =0.70
√
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 meters (m).
Field strengths from fixed RF
transmitters, as determined by
an electromagnetic site
surv ey, should be less than
the compliance lev el in each
frequency range.
Interference may occur in the
v icinity of equipment
containing a transmitter.
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
3 V/m
80 MHz to 2.5
GHz
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.
Note: Field strengths from fixed transmitters, such as base stations for
radio (cellular/cordless) telephones and land mobile radios, amateur
radio, AM and FM broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment
due to fixed RF transmitters, and electromagnetic site survey should be
considered. If the measured field strength in the location in which the
Ulthera system is used exceeds the applicable RF compliance level
above, the Ulthera system should be observed to verify normal
operation. If abnormal performance is observed, additional measures
may be necessary, such as re-orienting or relocating the system.