Integra CUSA Clarity Operator's Manual page 136

Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The CUSA Clarity system is intended for use in the electromagnetic environment specified below. The
customer or the user of the CUSA Clarity system should assure that it is used in such an environment.
IMMUNITY Test
Conducted
RF Immunity
150 kHz to 80 MHz
IEC 61000-4-6
in ISM and amateur
radio bands (4
Radiated
80 MHz to 2.5 GHz
RF Immunity
IEC 61000-4-3
80 MHz to 2.7 GHz
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 reflection from structures, objects, and people.
CUSA Clarity Ultrasonic Surgical Aspirator System Operator's Manual
®
IEC 60601
Compliance Level
Test Level
3 Vrms
150 kHz to 80 MHz
(3 and 4 ed.)
rd th
6 Vrms
in ISM and amateur
ed.)
th
3 V/m
80 MHz to 2.7 GHz
(3 ed.)
rd
(4 ed.)
th
Electromagnetic Environment -
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
3 Vrms
d =1,2P
d =1,2P
6 Vrms
radio bands
d =2,4P
Where P is the maximum output power
3 V/m
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
less than the compliance level in each
frequency range
Interference may occur in the vicinity of
equipment marked with the following
symbol:
Voluntary Standards
Guidance
80 MHz to 800 MHz
800 MHz to 2.7 GHz
, should be
a
.
b
A-9