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WARNING:
Qualified and specialized
personnel.
The device must be used
exclusively by specialized and appropriately
trained personnel such as a licensed dentist
completely familiar with the required
techniques and instructions for use of the
equipment. The use of the device does not
cause side effects if it is used correctly. An
improper use might cause tissues heating.
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 PIEZOSURGERY® GP 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
traditional methods such as drills or oscillating
saws (which act with macrovibrations),
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.
1.2.1 Users
U.S. Federal law restricts this device to sale by or on the order of a licensed dentist.
1.3
Disclaimer
The manufacturer Mectron and the distributor, Piezosurgery Inc. disclaim any liability, expressed
or implied, and shall have no responsibility for any direct, indirect or other damages and
personal injury arising out in connection with any improper practice in the use of the device and
its accessories. The manufacturer Mectron and the distributor, Piezosurgery Inc. shall be under
no liability, expressed or implied, with respect to any damages (personal injury and/or damage
to property) which might arise or be caused, whether by the customer or by any of the users of
the product and its accessories, as result of:
1.
Use or procedures different than those
specified in the intended use of the
product;
2. The environmental conditions for the
preservation and storage of the device
are not compliant to the precautions
indicated in the
25;
3. The device is not used in compliance
with all the instructions and precautions
described in this manual;
4. The electrical system in the premises
in which the device is used is not
compliant to the norms in force and to
the relative precautions;
5.
The assembly operations, extensions,
adjustments, updates, and repairs on
the device are performed by personnel
not authorized by Piezosurgery Inc.;
6. Improper use, mistreatments, and/or
incorrect interventions;
7.
Any and all attempts to tamper with
or modify the device, under any
circumstance;
8. Use of non-original Piezosurgery/
Mectron inserts that entail a finite
damage to the threading of the
handpiece, thus compromising correct
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