Boston Scientific MAESTRO 4000 Manual De Instrucciones página 27

Guidance and Manufacturer's Declaration – electromagnetic immunity
The Maestro 4000™ Cardiac Ablation System is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the Maestro 4000 Cardiac Ablation
System can help prevent electromagnetic interference by maintaining a minimum distance between portable
and mobile RF communications equipment (transmitters) and the Maestro 4000 Cardiac Ablation System as
recommended below, according to the maximum output power of the communications equipment.
Rated Maximum Output
Power of Transmitter
W
0.01
0.1
1
10
100
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined
using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer.
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.
Power Delivery
Refer to Table 1 for maximum power settings. In the event of unusually high or low tissue impedance, the System
limits the maximum power. Figure 6 through Figure 9 depict the maximum output power of the System (as a
function of tissue impedance) as measured at the output of the catheter for each catheter-pod configuration.
Figure 10 depicts the nominal, minimum, and maximum output power of the Generator as a function of the
control setting at nominal impedance of 100 Ω.
Note: Due to the inductive and capacitive loads presented by each Catheter configuration, the power delivered
at the Catheter tip may be less than the power on the System display.
Maestro 4000™ Cardiac Ablation System Operator's Manual, Global
Separation Distance According to Frequency of Transmitter
150 kHz to 80 MHz
d = 1.17√ P
0.12
0.37
1.17
3.70
11.7
M
80 MHz to 800 MHz
d = 1.17√ P
0.12
0.37
1.17
3.70
11.7
800 MHz to 2.5 GHz
d = 2.33√ P
0.23
0.74
2.33
7.37
23.3
27
Black (K) ∆E ≤5.0