Instructions For Use – neXus Ultrasonic Surgical Aspirator
Doc #: 100-10-1000 rev A
p 12
Contact with vibrating elements like extension and ultrasonic tip may cause burns and should be avoided by all
means. The handpiece should only be held at the black housing area. An optional, protective silicone sleeve, included
with certain tips, reduces the risk of thermal damage but does not eliminate it. Contact with the silicone sleeve
should be avoided or kept brief with minimal amount of contact pressure. Pressure and extended exposure can still
result in excessive frictional heat and cause burns.
Additional external irrigation, e.g. by administering sterile saline with a syringe over the distal tip portion, may
be necessary for removal of very dense, hard osseous structures of the skull, when using the neXus
Ultrasonic Surgical Aspirator System accessories.
Ultrasonic tips can break under excessive use in extreme conditions, e.g. when cutting for extended / duration in
tight cavities with limited lateral motion. The tip could break into two or more fragments with the main fragment
remaining attached to the handpiece. All fragments must be retrieved immediately from the surgical site. The
fragments should be checked to ensure that no further pieces are missing. It is possible that a fragment is propelled
outside of the surgical cavity. Diagnostic imaging, such as X-ray, must be used if a fragment cannot be found to
confirm that the broken piece is outside of the surgical cavity.
Breakage of ultrasonic tips will result in sharp edges that can be harmful to soft tissue even without activation
of ultrasound. Tips can bend or deform before they actually brake. Tips showing signs of deformation or cracking
should be replaced immediately since tip breakage is otherwise imminent. Do not bend or twist the ultrasonic tips
since it reduces the structural integrity and can result in tip breakage during use. Dispose of deformed or broken
tips immediately in a biohazardous sharps container in accordance with your facility biological hazardous waste
procedure.
Do not operate pump with pump cover in raised position. Rollers might pinch loose clothing or fingers.
Personal injuries may result.
Improper connection of the handpiece cable may present a shock hazard. Confirm that handpiece connector
is dry prior to plugging it in.
Heat is being generated at the tip/tissue interface. A continuous, lateral sweeping motion is recommended
for general bone/tissue removal in order to minimize contact duration with the ultrasonic tip and minimize
the temperature increase.
During system check, 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
Inadvertent or improper foot pedal depression can cause possible injury to the patient, surgeon, or
operating room staff and can damage the product. Place foot pedal where it is highly visible and labels can
be clearly seen.
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 objects.
Remove probe cover, ultrasonic tip and extension from the handpiece prior to cleaning and/or sterilization;
otherwise proper cleaning/sterilization may be inhibited.
Single-use items (tips, sheaths, tubing sets) are marked with the international symbol for “do not reuse -
single use only” (
). Discard these items following each surgical procedure in accordance with the hospital
protocol for biohazardous waste. Tips are to be disposed of in a biohazardous sharps container. To prevent
the risk of malfunction and transmission of disease, do not attempt to reprocess, clean, resterilize, and/or
reuse these items.
Immediately suspend operation if a persistent Electrical Fault appears on display and/or an Electrical Fault
audible indicator sounds. Remove ultrasonic tip from surgical site. Turn Mains Power OFF. Do not touch any
metallic parts of handpiece, extension, ultrasonic tip or generator while fault is indicated.
Proper system grounding can only be ensured when an approved, hospital-grade receptacle and matching
power cord are used. To avoid the risk of electric shock, this equipment must only be connected to a supply
with protective earth. Install plug and receptacles as per local regulations before operating the unit. Power
cord, plug and receptacle should be examined to verify that they are in good working condition before
connecting the console. Never pull on the power cord to remove it from the receptacle.
If a Mains Power fuse fails after replacement when the unit is reactivated, discontinue use of the device and
contact an authorized Misonix representative.
