Greenlight XPS - Page 21

Boston Scientific (User’s Manual Template 8.5in x 11in Global, 91091755 Rev/Ver. AA), Manual, MB, XPS, Global, 50623316-01A_pretrans
Black (K) ∆E ≤5.0Black (K) ∆E ≤5.0
21
Guidance and Manufacturer’s Declaration — Electromagnetic Immunity
The GreenLight XPS™ Laser System is intended for use in the electromagnetic environment specified below. The customer or user of the GreenLight
XPS Laser System should assure 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
150 kHz to 80 MHz
3V/m
80 MHz to 2.5 GHz
3 Vrms
3V/m
Portable and mobile RF communications equipment should be
used no closer to any part of the GreenLight XPS Laser System,
including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of the
transmitter.
Recommended separation distance d = 1.7 * P ½
d = 1.7 * P ½ 80 MHz to 800 MHz
d = 2.3 * P ½ 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 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 separation distance for 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
GreenLight XPS Laser System is used exceeds the applicable RF compliance level above, the GreenLight XPS Laser 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
GreenLight XPS Laser System.
b
Overthefrequencyrange150kHzto80MHz,fieldstrengthsshouldbelessthan3V/m.