Intended Use; Description Of The Device - Mectron Piezosurgery Plus Gebrauchs- Und Wartungsanleitung

1.1 Intended Use

WARNING: Only use the device and its
accessories for their intended use. Failure
to comply with this requirement may lead
to serious injury to the patient or operator,
and damage/failure of the device and of its
accessories.
PIEZOSURGERY plus is a surgical ultrasound
device used to cut bone, fitted with handpieces
and specific inserts that enable osteotomy and
osteoplasty techniques and to drill holes in a
variety of surgical procedures:
• Otorhinolaryngology;
• Oral-maxillofacial surgery;
• Hand and foot surgery;
• Neurosurgery;
• Spinal surgery;

1.2 Description of the Device

The PIEZOSURGERY
piezoelectric ultrasound
generate mechanical micro vibrations that can
cut through mineralised structures.
This allows an efficient and safe cutting which
preserves the integrity of the osteotomized
surfaces. The micrometric, ultrasonic vibrations
of the inserts provide greater precision
and a selective cutting action compared to
traditional methods such as drills or oscillating
saws (which act with
therefore minimizing traumatic effect on soft
tissues.
The PIEZOSURGERY plus has two piezoelectric
channels of different power types and with
independent electronics.
Channel 1 enables
medical handpiece to be used, to which the
sterile, single-use compatible inserts can be
connected (in accordance with the manual of
each insert).
Channel 2 enables
medical+ handpiece to be used, to which the
sterile, single-use compatible inserts can be
connected (in accordance with the manual of
each insert).
2
plus device uses
technology to
macrovibrations),
the PIEZOSURGERY
the PIEZOSURGERY
• Plastic-reconstructive surgery;
• Orthopaedics;
• Thoracic surgery.
PIEZOSURGERY medical and PIEZOSURGERY
medical + handpieces are accessory medical
devices for PIEZOSURGERY plus.
The PIEZOSURGERY
PIEZOSURGERY medical + handpieces are
intended for oral bone surgery, with the same
intende d use of the device when connected to
PIEZOSURGERY plus and compatible inserts.
WARNING: The device and its
accessories must be used in the operating
theatre of a hospital.
WARNING: PIEZOSURGERY plus is not
suitable for direct cardiac application.
WARNING: All handpieces can be
used in the applications specified in the
intended use. The PIEZOSURGERY medical+
handpiece is especially recommended in the
case of highly mineralised bone.
The touch screen
immediately available; they are activated by
simply pressing the finger against the screen
at the chosen buttons. The user can use the
graphic interface to select the chosen insert
and set the power type and irrigation values
within a range pre-established by Mectron.
NOTE: To prevent the treated parts from
overheating, we recommend increasing
irrigation levels as power type increases.
WARNING: Risk of explosion.
The device and its accessories cannot
function in places where there is an
atmosphere saturated with flammable gases
(anaesthetic mixtures, oxygen, etc.).
medical and
makes all functions