Tyco Healthcare AutoSonix Manual Del Operador página 10

Guidance and manufacturer's declaration – electromagnetic immunity
The AutoSonix™ Ultrasonic Surgical System is intended for use in the electromagnetic environment specified below. The customer or the
user of the AutoSonix™ Ultrasonic Surgical 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
a
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 AutoSonix™ Ultrasonic Surgical System is used exceeds the applicable RF compliance level above, the AutoSonix™
Ultrasonic Surgical 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 AutoSonix™ Ultrasonic Surgical System.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
b
portable and mobile RF communications equipment and the AutoSonix™ Ultrasonic Surgical System
The AutoSonix™ Ultrasonic Surgical System is intended for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the AutoSonix™ Ultrasonic Surgical System can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the AutoSonix™
Ultrasonic Surgical 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
Compliance
level
Portable and mobile RF communications equipment should be used
no closer to any part of the AutoSonix™ Ultrasonic Surgical System,
including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of the
transmitter.
Recommended separation distance
d = 1.2√P
d = 1.2√P 80 MHz to 800 MHz
3 V
d = 2.3√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 deter-mined by an
3 V/m
electromagnetic site survey,
level in each frequency range.
Interference may occur in the vicinity of equipment marked with the
following symbol:
Recommended separation distances between
Separation distance according to frequency of transmitter
150 kHz to 80 MHz
d = 1.2√P
0.12
0.37
1.2
3.7
12
4
Electromagnetic environment – guidance
should be less than the compliance
a
b
m
80 MHz to 800 MHz
d = 1.2√P
0.12
0.37
1.2
3.7
12
(Table 204)
(Table 206)
800 MHz to 2,5 GHz
d = 2.3√P
0.23
0.37
2.3
7.4
23