Instructions for Use SonaStar Ultrasonic Surgical Aspiration System
IFU-601 Rev T March 2023 Page 8 of 73
FCC Statement: This complies with FCC regulations for conducted and radiated emissions under
FCC Part 18.
UL Statement: This complies with UL Standard 2601-1 as well as IEC 60601-1.
EMC Statement: The SonaStar system is designed and tested to comply with FCC regulations for
conducted and radiated emissions under Part 18 Subchapter J. and to comply with IEC EN60601-1-2:
2007 guidelines for EMC.
List of cables, transducers and accessories:
Item Cable Length Type
Ultrasonic Transducer NA NA
Transducer Cable 5.2m shielded multi-conductor
Remote IR Receiver Cable 5.5m shielded multi-conductor
AC Main Power Cord 3.0m unshielded 3-conductor
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
(Table 201)
The SonaStar Ultrasonic Surgical Aspirator
is intended for use in the electromagnetic environment specified below. The customer or the user of
the Ultrasonic Surgical Aspirator should assure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic Environment – Guidance
RF emissions
GB 4824
Group 1
The SonaStar Ultrasonic Surgical Aspirator uses RF energy
only for its internal function. Therefore, its RF emissions are
very low and are not likely to cause any interference in
nearby electronic equipment.
RF emissions
GB 4824
Class A
The SonaStar Ultrasonic Surgical Aspirator is suitable for use
in all
establishments other than domestic and
those directly
connected to the public low-voltage
power supply network
that supplies buildings used for
domestic purposes.
Harmonic emissions
GB 17625.1
Class A
Voltage fluctuations/
flicker emissions
GB 17625.2
Complies
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