Instructions For Use – neXus Ultrasonic Surgical Aspirator
Doc #: 100-10-1000 rev A
p 21
WARNING
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.
CAUTION
Ultrasonic energy is inhibited if excessive physical force is applied to the ultrasonic tip; use only enough
force to guide the tip to the surgical site and to advance it through the tissue. Do not force the tip; allow
the ultrasonic action to do the work.
Tip Limitations During Bone Removal
Both the ultrasonic tip and the extension (horn) are vibrating at a high frequency and are thus exposed to extreme
mechanical stresses, especially when cutting bone.
WARNING
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.
WARNING
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 harps
container in accordance with your facility biological hazardous waste procedure.
CAUTION
Insufficient irrigation and high tip pressure (loading) under extended exposure, e.g. in tight cavities, are
to be avoided in hard tissue removal. It is recommended to withdraw and re-insert the ultrasonic tip
repeatedly to re-establish adequate cooling and lubrication.
CAUTION
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.
CAUTION
Loose tip/tissue contact upon an initial bone incision can cause a thin tip to resonate not only
longitudinally but also transversely. This can cause a thin tip to break. It is necessary to engage bone
actively and with a minimal tip pressure greater than zero in order to prevent the shattering.
CAUTION
Contact of the ultrasonic tip or the exposed extension with metal, surgical instruments or other
objects during ultrasound use must be avoided. Such contact can damage the ultrasonic components
very easily and may result in compromised performance, including failure. Discard any extensions or
tips that show signs of damages like gouges, nicks or fractures. External aspiration may be used but it is
recommended that a plastic suction tip should be used when in proximity with the probe tip.
