Mectron Piezosurgery plus Mode D'emploi Et D'entretien page 10

1.2 Description of the Device
The PIEZOSURGERY® plus
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
piezoelectric channels of different power
types and with independent electronics.
Channel 1 enables the PIEZOSURGERY
medical handpiece to be used, to which the
sterile, single-use PIEZOSURGERY
inserts can be connected.
Channel 2 enables the PIEZOSURGERY
medical+ handpiece to be used, to which the
1.2.1 Patient Group Directions
This medical device is designed to be used with the following patient population:
• Infants;
• Children;
• Adolescents;
• Adults;
• Elderly.
1.2.2 Patient Selection Criteria
The use of the device is not recommended in the following cases:
1. Patients with active implantable
medical devices (for example:
pacemakers, hearing aids and/or other
electromagnetic prostheses) without
the prior authorization of their doctor;
2. Women who are pregnant or
breastfeeding, due to the restrictions
associated with the possible use of
medical solutions such as anaesthetics
3. Patients with allergies;
2
device uses sterile, single-use PIEZOSURGERY
technology to
inserts can be connected.
the applications specified in the intended use.
The PIEZOSURGERY® medical+ handpiece is
especially recommended in the case of highly
mineralised bone.
The touch screen makes all functions
immediately available; they are activated by
macrovibrations),
simply pressing the finger against the screen
at the chosen buttons. The user can use the
graphic interface to select the chosen insert
has two
and set the power type and irrigation values
within a range pre-established by Mectron.
®
from overheating, we recommend increasing
medical irrigation levels as power type increases.
®
This medical device can be used on any
®
patient of any age, weight, height, gender and
nationality.
This medical device can be used on any
patient of any age, weight, height, gender and
nationality.
4.
5.
WARNING: All handpieces can be used in
WARNING: To prevent the treated parts
Patients with pathologies or clinical
conditions for which it is not
recommended to perform surgery
or for which it may represent a
contraindication according to the
treating physician. These conditions
may include, but are not limited to:
heart disease, diabetes, cirrhosis, HIV
infection, pregnancy or breastfeeding,
radiation therapy, chemotherapy,
immuno-suppressive therapy, allergies
and psychiatric disorders;
Patients with unsuitable treatment sites.
medical+
®