mectron Piezosurgery flex Gebrauchs- Und Wartungsanleitung Seite 29

WARNING: Breakage and wear-out of
the inserts. In rare cases, high frequency
oscillations and wear-out may lead to
breakage of an insert. Do not bend, reshape
or re-sharpen an insert in any way. Bending
or prying the insert tip may cause it to
fracture. Deformed or otherwise damaged
inserts are susceptible to breakage during
their use. These inserts must never be used.
During surgery, excessive pressure applied
on the insert tip may cause it to fracture. If
the insert tip contacts with metal objects, it
may break, leaving pieces in the surgical site.
Should an insert fracture during use, extreme
care must be exercised to ensure that all
the fragments of the insert are retrieved
and removed from the surgical site and, at
the same time, that an effective suction is
applied. During surgery, frequently check that
the insert is intact, especially in its apical part.
During surgery, avoid prolonged contact with
retractors or other metal objects being used.
WARNING: The PIEZoSURGERY®
Medical device is intended for bone cutting.
However, prolonged contact and/or excessive
force of the instrument tip on soft tissues
should be avoided as this may cause thermal
and/or blunt injury. Particular care should be
exercized when sharp tip inserts are used.
Prolonged mechanical action of a sharp insert
may also result in the soft tissue being cut. In
close proximity to soft tissues/nerves (e.g. the
perinevrium of the peripheral nerve system,
or dura mater of central nerve system), it is
recommended to complete the cut with a
blunt tip diamond coated insert, to minimize
the potential for soft tissue damage.
WARNING: Carefully check that the
PIEZoSURGERY® Medical handpiece is
correctly working in all its parts before using
it on the patient.
CAUTION: Intermittent operation. Long
operational periods could cause overheating
of the handpiece body. Refer to the Chapter
8 on page 26 for the recommended duty
cycle.
WARNING: Sterility. The insert tip is
supplied sterile by prior exposure to ethylene
oxide gas (ETO).
WARNING: Single-use. The
PIEZoSURGERY® Medical insert is intended
to be used on an individual patient during a
single surgical procedure and then discarded.
The insert is not intended to be reprocessed,
re-sterilized and used again. Remove and
discard the insert following local regulations
for proper disposal of contaminated surgical
materials.
WARNING: During surgery, do not
perform any maintenance activity on the
system.
WARNING: The device is classified for
intermittent mode operation (as reported
in Chapter 8 on page 28
use of the device for a prolonged time and
in any case exceeding the declared time
limits can cause overheating, in particular, of
the handpiece. In case of overheating, avoid
contact of the handpiece with the operator
and the patient.
USE
). The continuous
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