Recommended Separation Distance - Boston Scientific MAESTRO 4000 Manual De Instrucciones

Guidance and manufacturer's declaration – electromagnetic immunity
The Maestro 4000™ Cardiac Ablation System is intended for use in the electromagnetic environment
specified below. The customer or the user of the Maestro 4000 Cardiac Ablation System 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.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,
a
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
Maestro 4000 Cardiac Ablation System or any of its components are used exceeds the applicable RF compliance level above, the Maestro 4000
Cardiac Ablation System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating components or the entire Maestro 4000 Cardiac Ablation System.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
b
26
Black (K) ∆E ≤5.0
Compliance level Electromagnetic environment - guidance
3 Vrms Portable and mobile RF communications
equipment should be used no closer to
3 V/m
any part of the Maestro 4000 Cardiac
Ablation System, including cables, than
the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.

Recommended separation distance:

d = 1.17√ P 150 kHz to 80 MHz
d = 1.17√ P 80 MHz to 800 MHz
d = 2.33√ 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,
level in each frequency range.
Interference may occur in the vicinity of
equipment marked with the following symbol:
Maestro 4000™ Cardiac Ablation System Operator's Manual, Global
should be less than the compliance
a
b