Instructions for Use SonaStar Ultrasonic Surgical Aspiration System
IFU-601 Rev T March 2023 Page 4 of 73
CHAPTER 1
OPERATING SAFETY PRECAUTIONS
1.1 General
Please read this section of the manual carefully. It contains a summary of all warnings, cautions, and
notes contained in the manual. However, the user is strongly advised to read the entire manual and
operate the SonaStar system in accordance with all the instructions contained herein in addition to
instructions that may be supplied with accessories.
1.2 Conventions: Warnings, Cautions, and Notes
Warning Denotes potentially dangerous situation that could result in death or serious injury to
patient, operator, or staff.
Caution Denotes potentially dangerous situation that could result in moderate injury to patient,
Indicates potential hazard that may result in product damage
1.3 Safety: Recommendations for the Use of this Device
Use of controls or adjustments, or performance of procedures other than as specified
herein may result in personal injury. Therefore, personnel operating or maintaining the
SonaStar system must be thoroughly familiar with its safety requirements and
operating procedures.
Any improper use or adjustment of this device may invalidate the Misonix Service
Warranty agreement. Please contact your authorized Misonix representative before
attempting to use this device in any manner other than those specified in this manual.
There are no user serviceable parts.
Misonix expressly disclaims all liability for any incidental or consequential damages to
the equipment or any personal injuries to the operator or patient arising from any
uthorized use, misuse or abuse of this equipment.
Proper system grounding cannot be ensured unless unit is connected to a properly
wired hospital grade outlet.
Therefore, to avoid the risk of electric shock, this
equipment must only be conn
o supply mains with protective earth.
Warning During vibration testing, make sure the tip of the handpiece is free from contact with
any object. Allowing contact with the tip may result in damage and/or personal injury.
Warning Once vibration is enabled by pressing either the Preset or Linear key, depressing the
footswitch will initiate vibration. Make sure that the handpiece is properly positioned
at the tissue site before the footswitch is depressed. Any inadvertent activation of the
Warning During system setup, a handpiece ultrasonic vibration test is required. Do not touch the
tip while testing the handpiece or at any time during operation as equipment damage
and/or personal injury may result. Do not allow the distal end of the tip to come in
Warning Do not lay the handpiece on the patient when not in use. When not in use, keep the
handpiece on a dry, non-conductive surface with the tip free from contact with any
Warning Inadvertent or improper foot pedal depression can cause possible injury to the patient,
surgeon, or operating room staff, and can cause product damage. Place foot pedal
where it is highly visible, and labels can be clearl