aptus Heli-FX Instrucciones De Uso página 27

Table 7: Guidance and manufacturer's declaration – electromagnetic immunity
The Heli-FX Applier is intended for use in the electromagnetic environment specified below.
The customer or the user of the Heli-FX Applier should assure that it is used in such an environment.
Immunity test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
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) and land mobile radios, amateur radio,
a
AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To access 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 (equipment or system) is used exceeds the applicable RF compliance level above, the (equipment
or 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 Heli-FX Applier.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
b
Heli-FX® EndoAnchor® System
IEC 60601 test level
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
Compliance Electromagnetic environment-
level guidance
Portable and mobile RF communications
3 Vrms equipment should be used no closer to any part
of the Heli-FX Applier, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency
to the transmitter.
Recommended separation distance
=
d
=
d
3 V/m
=
d
where P is the maximum output power rating
to the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in meters (m).
Field strength 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:
3 5 .
P
V 1
3 5 .
P
80 MHz to 800 MHz
E 1
7
P
800 MHz to 2.5 GHz
E 2
.
b
EN
,
a
22