Description Of The Device; Patient Group Directions; Patient Selection Criteria; Indications For Use - mectron Piezosurgery flex Gebrauchs- Und Wartungsanleitung

1.2 Description of the Device
The user interface has been optimized with the
PIEZOSURGERY® flex making all the functions
readily available by integrating them in the
touch keyboard.
The PIEZOSURGERY® flex 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
1.2.3 Indications for Use
The use of the device is suitable for all the appropriate patients (see chapter above) for whom a
bone surgery treatment is prescribed, by the treating physician, within the intended use of the
device (see Chapter 1.1 on page 1
2
flex
traditional methods such as drills or oscillating
saws
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.
5.
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.
).
(which act with
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.
macrovibrations),