Mectron PIEZOSURGERY WHITE Mode D'emploi Et D'entretien page 15

WARNING: Breakage and wear-out of
the inserts. High frequency oscillations and
wear-out may, in rare circumstances, lead to
the breakage of the insert.
Deformed or otherwise damaged inserts are
susceptible to breakage during their use.
These inserts must never be used.
If an insert breaks, check that none of its
fragments remain in the treated part and,
at the same time, apply effective suction to
remove them.
The patient must be instructed to breathe
through his nose during the treatment, or
a dental dam must be used to prevent the
patient from ingesting fragments of broken
inserts.
When the nitride coating wears out, the
cutting efficiency decreases; re-sharpening
the insert damages it and is therefore
forbidden. Check that the insert is not worn
out. Use of a worn-out insert reduces the
cutting performance and can cause necrosis
of the bone surface treated.
During the intervention, frequently check that
the insert is intact, especially in its apical part.
During the intervention, avoid prolonged
contact with retractors or with metallic
instrumentation in use. Do not exert excessive
pressure on the inserts during their use.
WARNING: Only use original Mectron
inserts, accessories, and spare parts.
WARNING: Contraindications. Do not
use the PIEZOSURGERY® white on patients
who carry heart stimulators (Pace-makers)
or other implantable electronic devices. This
precaution also applies to the operator.
CAUTION: Contraindications. Do not
perform treatments on prosthetic artifacts
made of metal or ceramics. The ultrasonic
vibrations could lead to the de-cementing of
the artifacts.
WARNING: Contraindications.
Interference from other equipment. An
electrical scalpel or other electro-surgical
units near the PIEZOSURGERY® white device
may interfere with its correct operation.
INTRODUCTION
WARNING: Contraindications.
Interference with other equipment.
Although PIEZOSURGERY® white complies
with standard IEC 60601-1-2, it may interfere
with other equipment located nearby.
PIEZOSURGERY® white must not be used
near, or stacked on other equipment. Install
PIEZOSURGERY® white at a safe distance
from life-support equipment. If necessary,
however, prior their use, please check
and monitor that the device and all other
equipment function correctly in that layout.
CAUTION: No modification of this
equipment is allowed.
WARNING: Personal injury. Take care
to ensure that cables do not hinder the free
movement of personnel.
CAUTION: US Federal Law (of the United
States of America) restricts this device to sale
by or on the order of a physician.
WARNING: Do not activate the device if
the handpiece is faulty, damaged or broken.
Replace the handpiece immediately.
WARNING: If an adverse event and/or
serious accident attributable to the device
occurs during correct and intended use, it is
recommended to report it to the Competent
Authority and to the manufacturer indicated
on the product label.
WARNING: PIEZOSURGERY® white is a
device intended for bone surgery. 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. Take particular care when
sharp 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, it is recommended to
complete the cut with a blunt tip diamond
coated insert, to minimize the potential for
soft tissue damage.
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