Instructions for Use SonaStar Ultrasonic Surgical Aspiration System
IFU-601 Rev T March 2023 Page 5 of 73
Warning
Saline leakage through handpiece housing can cause a hazard when electrosurgery is
energized. Always make sure the handpiece housing parts are properly assembled,
with mating parts firmly in contact.
Warning Never activate Vibration or electrosurgery while using the cleaning stylet. Tip damage
and operator, patient, or staff injury may result.
Warning Improper assembly of Single-Use Monopolar Handpiece Cable to endcap can expose
potentially dangerous electrosurgery voltage. Always make sure the Single-Use
Monopolar Handpiece Cable socket is firmly and fully engaged onto the pin in the
Warning The handpiece and cable should be carefully inspected for cuts, cracks, or other signs of
damage before each use. Any damaged equipment should be returned to your sales
representative or dealer for repair or replacement.
Warning Use only sterilization cycles specified in this user manual. Do not use any other
sterilization cycles. Improper sterilization can lead to handpiece or accessory damage,
patient injury, or death.
Warning Explosion hazard. Never use the SonaStar system in the presence of a flammable or
explosive atmosphere, such as flammable anesthetics.
Warning The Sonastar system, including all accessories and components, is MR unsafe.
It must not brought into the MR environment.
Warning The use of accessories, transducers and cables other than those specified, with the
exception of transducers and cables sold by the manufacturer of the SonaStar
Ultrasonic Surgical Aspirator as replacement parts for internal components, may result
in increased emissions or decreased immunity of the SonaStar Ultrasonic Surgical
Warning The SonaStar Ultrasonic Surgical Aspirator should not be used adjacent to or stacked
with other equipment. If adjacent or stacked use is necessary, the SonaStar Ultrasonic
Surgical Aspirator should be observed to verify normal operation in the configuration in
Special Skills and Training Requirements
1) U.S. federal law restricts this device to sale by, or on the order of a licensed
healthcare practitioner.
2) The SonaStar Ultrasonic Surgical Aspirator is to be used by an appropriately
trained and licensed healthcare practitioner.
The handpiece, accessories,
footswitch, remote IR receiver and generator
should never be immersed in liquids, since irreparable damage may result.
Caution The "Vacuum" port of the suction canister should contain a positive shut-off float. The
aspiration pump connection should be made only to the vacuum port to prevent
Caution Incorrect routing of irrigation tubing will result in no flow of irrigating solution to the
tip. This may cause damage to handpiece and probe.
Caution Be careful not to scratch or damage the tip when sliding the torque wrench over the
tip. Failure may result from scratches or damage to the probe when enabl
Caution Do not use ultrasonic cleaners to clean the Handpiece. Use manual cleaning
Caution Be certain to clear all particles and any debris from the Handpiece internal passage and
all cavities by brushing thoroughly. Failure to do so may hinder sterilization of units
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