E-SOUM-PLUS Rev E
17
CAUTION 4.1
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
The SonicOne Clinic reusable tips are used for soft tissue wound debridement.
The SonicOne Clinic may be used with Misonix SonicOne OR or BoneScalpel sterile, single use disposable tips. BoneScalpel
tips are used for bone cutting and bone shaving in cases where bone is involved in the wound. Some SonicOne OR tips offer
a vacuum sheath for aspiration of irrigation fluid and reduction in spray. Contact your sales representative for assistance
with ordering SonicOne OR or BoneScalpel tips for use with the SonicOne Clinic console and handpiece.
Both the ultrasonic tip and the extension are vibrating at high frequency and are thus exposed to extreme mechanical stresses,
especially when cutting bone.
Note: When using Bonescalpel or SonicOne OR parts refer to their respective IFU’s for instruction on assembly and
disassembly.
WARNING 4.2 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 4.3 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 sharps container.
CAUTION 4.2
Insufficient irrigation and high tip pressure (loading) under extended exposure, e.g. in tight cavities, are to
be avoided in SonicOne CLINIC hard tissue removal. It is recommended to withdraw and re-insert the
ultrasonic tip repeatedly to re-establish adequate cooling and lubrication.
CAUTION 4.3
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 SonicOne
CLINIC accessories.
NOTE 4.2
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.
NOTE 4.3
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.
