Shockwave Medical Lithoplasty 825D Manual Del Operador página 29

Electromagnetic Compatibility Guidance – RF Immunity
The Generator, Model 825D is intended for use in the electromagnetic environment specified below. The customer or the user
of the Generator, Model 825D 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 Model 825D is used exceeds the applicable RF compliance level
above, the Model 825D should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the Model 825D.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
LBL 60780 rev. B
Guidance and manufacturer's declaration – electromagnetic immunity
IEC 60601 test level
3 Vrms
150 kHz to 80 MHz [V1=3] V
3 V/m [E1=3] V/m
80 MHz to 2,5 GHz
Compliance level
Portable and mobile RF communications equipment
should be used no closer to any part of the Generator
Model 825D, 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 meters (m). Field strengths from fixed RF
transmitters, as determined by an electromagnetic site
survey
each frequency range
vicinity of equipment marked with the following
symbol:
Electromagnetic environment – guidance
a
, should be less than the compliance level in
b
Interference may occur in the
EN
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