mectron PIEZOSURGERY plus, Use And Maintenance Manual, Page: 8 / 60

2
WARNING : Qualified and specialised
personnel. This device may only be used by
specialised personnel such as a surgeon with
proper medical culture; no training activities
are foreseen for the use of the device. If
correctly used, this device causes no side
effects. Improper use, on the other hand, will
transmit heat to the tissues.
WARNING : Risk of explosion.
The device cannot function in places where
there is an atmosphere saturated with
flammable gases (anaesthetic mixtures,
oxygen, etc.).
WARNING : PIEZOSURGERY® plus is not
suitable for direct cardiac application.
1.2 Description of the Device
The PIEZOSuRGERY® plus device uses
piezoelectric ultrasound technology to
generate mechanical micro vibrations that can
cut through mineralised structures causing
minimal damage to soft tissues.
The PIEZOSuRGERY® plus has two
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
®
medical
inserts can be connected.
Channel 2 enables the PIEZOSuRGERY
®
handpiece to be used, to which the
sterile, single-use PIEZOSuRGERY
®
inserts can be connected.
WARNING : All handpieces can be used in
the applications specified in the intended use.
The PIEZOSuRGERY® handpiece is
especially recommended in the case of highly
mineralised bone.
The touch screen makes all functions
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 the
manufacturer Mectron.
WARNING : To prevent the treated parts
from overheating, we recommend increasing
irrigation levels as power type increases.
1.2.1 Users
U.S. Federal law restricts this device to sale by or on the order of a licensed physician.
1.3 Disclaimer
The manufacturer Mectron and the distributor, Piezosurgery Inc., refuse all specific or implicit
liability and shall not be held liable for any direct or indirect injury to people and/or damage to
objects occurring following incorrect procedures connected with the use of the device and its
accessories.
The manufacturer, Mectron and the distributor, Piezosurgery Inc. cannot be held specifically or
implicitly liable for any type of injury to people and/or damages to objects caused by the user of
the product and its accessories and which took place in the following cases:
1. Use in procedures other than those
specified in the product’s intended use;
2. The environmental conditions in which
the device is kept and stored do not
comply with the requirements indicated
in the Chapter 7 on page 31 ;
3. The device is not used in accordance
with the instructions and requirements
described in this manual;
4. The wiring systems in the room where
the device is used do not comply with
the applicable standards and relevant
requirements;
5. Device assembly, extension, regulation,
update or repair has been carried
out by personnel not authorised