Standards and IEC Classifications
5-10 CUSA EXcel Ultrasonic Surgical Aspirator System Service Manual
Guidance and manufacturer's declaration - electromagnetic immunity
The CUSA EXcel is intended for use in the electromagnetic environment specified below. The customer or the user of the CUSA
EXcel should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment -
guidance
Conducted RF
IEC 61000-4-6
Radiated RF IEC
61000-4-3
3 Vrms
150KHz to 80MHz
3 V/m
80MHz to 2.5GHz
3 V
7 V/m
Portable and mobile RF
communications equipment should be
used no closer to any part of the CUSA
EXcel, including cables, than the
recommended separation distance
calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance
d=1/2ÐP
d=0.5ÐP 80MHz to 800MHz
d=ÐP 800MHz to 2.5GHz
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, should be
less than the compliance level in each
frequency range
Interference may occur in the vicinity
of equipment marked with the
following symbol:
NOTE 1 At a80MHz and 800MHz, 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 CUSA EXcel is used exceeds the applicable RF compliance level above, the CUSA
EXcel should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the CUSA EXcel.
b. Over the frequency range 150kHz to 80MHz, field strengths should be less than 3 V/m.
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