Boston Scientific Vessix Generator Mode D'emploi page 14

table 3: Guidance and manufacturer's declaration – electromagnetic immunity
The Vessix™ Generator is intended for use in the electromagnetic environment specified below. The customer or the
user of the Vessix Generator should assure that it is used in such an environment.
IMMUnIty test Iec 60601 test level
Conducted RF 3 Vrms
(IEC 61000-4-6) 150 kHz to 80 MHz
Radiated RF 3 V/m
(IEC 61000-4-3) 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 3 The Vessix™ System has been qualified to use an internal feature that functions at 13.56 MHz. This function may be impaired at 13.5, 27.0 and 40.5 MHz
frequencies.
NOTE 4 If the compliance levels differ from those stated then the equations in the "guidance" column must be updated as well as the equations and separation
distances noted in Table 4. This is in addition to disclosure and justification that is required whenever test levels are not met.
NOTE 5 Although omitted from the standard, for clarity, the first equation for "d =..." should be followed by "150 kHz to 80 MHz".
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 Vessix Generator is used exceeds the
applicable RF compliance level above, the Vessix Generator should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as re-orienting or relocating the Vessix Generator.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Black (K) ∆E ≤5.0
compliance level electromagnetic environment – guidance
4
Portable and mobile RF communications equipment
should be used no closer to any part of the Vessix
Generator, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
recommended separation distance
3.5 √ P
d =
3
3.5 √ P
d =
3
3 Vrms
7 √ P
d =
3
3 V/m
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,
should be less than the compliance level in each
frequency range.
Interference may occur in the vicinity of equipment
marked with the following symbol:
14
1 2 3
5
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
b
a