Description Of The Device; Patient Group Directions; Patient Selection Criteria - Mectron PIEZOSURGERY WHITE Mode D'emploi Et D'entretien

WARNING: Use the device only for the
intended use.
Failure to observe this precaution may cause
serious injuries to the patient, the operator,
and damages/breakdowns to the device.
1.2 Description of the Device
The user interface has been optimized with
the PIEZOSURGERY® white making all the
functions readily available by integrating them
in the touch keyboard.
The PIEZOSURGERY® white is a device that
uses ultrasonic piezoelectric technology to
generate mechanical microvibrations of the
inserts, to effectively cut mineralized tissues.
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
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;
4. Patients with pathologies or clinical
conditions for which it is not
recommended to perform surgery
2
WARNING: Carefully read and apply the
recommendations given in this manual to
avoid all risk to patient and/or user safety.
Failure to do so may lead to serious injury to
the patient and/or operator.
traditional methods such as drills or oscillating
saws (which act with
therefore minimizing traumatic effect on soft
tissues.
The cavitation effect of the irrigating solution
helps to keep the operatory field blood-free.
This provides an optimal intra-operatory
visual control thus increasing safety, even in
areas that are anatomically most difficult to
access.
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.
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;
5. Patients with unsuitable treatment sites.
All models of "Piezosurgery" bone surgery
devices are intended for professional use only.
Therefore, the user is the only person able to
decide if and how to treat their patients.
macrovibrations),