Cooper Surgical LEEP System 1000, Operating Manual

Page: 28 / 196

26
LEEP System 1000
®
Workstation • Model KH1000A • Operating Manual • English
(continued)
Immunity
Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environmental – guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 V
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the Electrosurgical Generator, including
cables, than the recommended separation
distance calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance
80 MHz to 800 MHz
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
meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey
a
,
should be less than the compliance level in
each frequency range
b
.
Interference may occur in the vicinity of
equipment marked with the following symbol:
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.
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 LEEP System 1000
®
Workstation is used exceeds the applicable RF
compliance level above, the Electrosurgical Generator should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the LEEP System 1000 Workstation.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.