Instructions for Use SonaStar Ultrasonic Surgical Aspiration System
IFU-601 Rev T March 2023 Page 6 of 73
Caution OsteoSculpt™ bone shaver probes are only to be installed on and used in conjunction
Caution Never operate the handpiece without proper irrigation. Irreparable damage to the
obe may result if adequate irrigation is not provided to the probe tip.
Caution The console and wireless footswitch must have the same frequency code number for
Caution Only the external surfaces of the console should be cleaned. Do not attempt to remove
any panels in order to clean or disinfect internal surfaces.
Caution It is strongly advised that a sterile backup handpiece be readily available in the
operating room as insurance against any contamination or malfunction of the
Caution Improper use or adjustment of this device may invalidate the Misonix, LLC warranty
agreement. Contact your authorized Misonix, LLC representative before attempting to
troubleshoot this device in any manner other than
Do not immerse the Handpiece, Cable, Footswitch, Remote IR Receiver or Generator.
The console is not sealed against liquids, and damage to equipment may result.
Caution If fault occurs suspend operation of handpiece and unit. Determine the cause of the
problem and its solution by consulting the troubleshooting section of this manua
Caution Simultaneous use of a separate monopolar instrument with ultrasound can create
sparking and possible tip damage.
Caution Electrosurgery units approved for use with this unit are listed in Section 7.1. Any
electrosurgery units used with this system should be operated at settings lower than
70. Failure to maintain the electrosurgery signal at settings below 70 can induce
Caution Use of a separate monopolar instrument at electrosurgery settings greater than 70
while simultaneously touching the handpiece probe to tissue can induce faults and
onjunction with bone shaving.
act with hard objects can cause
evice is limited to or on the order of a physician only.
Caution Aspiration pinch valve and irrigation pump can create pinch points. Keep fingers away
from these parts while operating unit. Use caution when assembling components.
that may be replaced by hospital technical staff are the three fuses on
the rear of the unit. Replacement fuses must be identical in type, voltage rating and
current rating to the original fuse.
Surgical Aspirator is consi
dered Medical Electrical Equipment.
Medical Electrical Equipment needs special precautions regarding Electromagnetic
Compatibility (EMC) and needs to be installed and put into service according to the
EMC information provided in this Operator’s manual.
Portable and mobile RF communication equipment can affect Medical Electrical
Equipment.
Note The Low Battery LED indicator should be checked when system is powered “ON”.
Note The IV pole should be positioned to yield continuous flow and visibility, but elevated IV
bag position is not necessary to achieve flow.
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