CUSA
®
Clarity Ultrasonic Surgical Aspirator System Operator’s Manual
A-9
Voluntary Standards
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The CUSA Clarity system is intended for use in the electromagnetic environment specied below. The
customer or the user of the CUSA Clarity system should assure that it is used in such an environment.
IMMUNITY Test
IEC 60601
Test Level
Compliance Level
Electromagnetic Environment -
Guidance
Conducted
RF Immunity
IEC 61000-4-6
Radiated
RF Immunity
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
(3
rd
and 4
th
ed.)
6 Vrms
in ISM and amateur
radio bands (4
th
ed.)
3 V/m
80 MHz to 2.5 GHz
(3
rd
ed.)
80 MHz to 2.7 GHz
(4
th
ed.)
3 Vrms
150 kHz to 80 MHz
6 Vrms
in ISM and amateur
radio bands
3 V/m
80 MHz to 2.7 GHz
Portable and mobile RF communications
equipment should be used no closer to
any part of the system, 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 2.7 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 xed 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: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reection from structures, objects, and people.
d =1,2P
d =1,2P
d =2,4P
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