Instructions For Use – neXus Ultrasonic Surgical Aspirator
Doc #: 100-10-1000 rev A
p 7
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
(Table 204)
The neXus Ultrasonic Surgical Aspirator System is intended for use in the electromagnetic environment specified below. The
customer or the user of the neXus Ultrasonic Surgical Aspirator System should assure that it is used in such an environment.
Immunity test
IEC 60601 test level
Compliance level
Electromagnetic environment – guidance
Portable and mobile RF communications
equipment should be used no closer to any part of
the neXus Ultrasonic System, including cables,
than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
6Vrms in ISM Bands
3 Vrms
150 KHz to 80 MHz
d = 1.2√P
d = 1.2√P
80 MHz to 800 MHz
Radiated RF
IEC 61000-4-3
3 V/m
80 Hz to 2.7 GHz
80% AM at 1Khz
3 V/m
80 MHz to 2.7 GHz
80% AM at 1Khz
d = 2.4√P
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 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.
NOTE 3 If a fault notification on the GUI occurs, press the “X” button to exit the screen and initiate system reset.
Table 1.4 Guidance & manufacturer’s declaration on electromagnetic immunity (EN table 204)
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 neXus Ultrasonic Surgical Aspirator System is
used exceeds the applicable RF compliance level above, the neXus Ultrasonic Surgical Aspirator 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
neXus Ultrasonic System.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
