mectron PIEZOSURGERY plus, Use And Maintenance Manual, Page: 9 / 60

3
INTRODuCTION
by Piezosurgery Inc.; all assistance
services must be provided by qualified
personnel only;
CAUTION : The back-up battery must be
replaced with a CR2032 type identical battery,
by Piezosurgery Inc.’s Service.
6. Improper use, damage and/or incorrect
interventions;
7. All attempted tampering or changes to
the device in any circumstances;
8. use of non-original Piezosurgery/
Mectron inserts, which definitively
damages the handpiece thread,
affecting correct function and risking
injury to the patient;
9. use of non-original Piezosurgery/
Mectron inserts, used according to the
settings designed and tested on original
Piezosurgery/Mectron inserts. Correct
use of settings is only guaranteed with
original Piezosurgery/Mectron inserts;
10. Lack of spare materials (handpiece,
inserts, wrenches) to be used in the
event of failure or problem.
1.4 Safety Requirements
WARNING : MR-UNSAFE
PIEZOSuRGERY® plus MuST NOT BE uSED in
a Magnetic Resonance (MR) environment.
WARNING : Risk of explosion.
The device cannot operate in environments
where the atmosphere is saturated with
flammable gases (anaesthetic mixtures,
oxygen, etc.).
WARNING : Contraindications.
Interference with other equipment.
Although PIEZOSURGERY® plus complies
with standard IEC 60601-1-2, it may interfere
with other equipment located nearby.
PIEZOSURGERY® plus must not be used
near, or stacked on other equipment. Install
PIEZOSURGERY® plus at a safe distance
from life-support equipment. If necessary,
however, prior their use, please check
and monitor that the device and all other
equipment function correctly in that layout.
WARNING : Contraindications.
Interference by other equipment. An
electrosurgical knife of other electrosurgical
devices near the PIEZOSURGERY® plus
device, may interfere with its correct
functioning.
CAUTION : If the end user should need
to submit the equipment in its facility to
regular checks, in order to comply with
relevant requirements, the test procedures
to be applied to electromedical systems and
devices to evaluate safety must be carried
out by means of standard EN 62353 “Medical
Electrical Equipment - recurrent test and test
after repair of medical electrical equipment”.
The interval for periodic checks, in the
intended operating conditions and described
in this “Use and Maintenance” manual, is one
year.
WARNING : Check the condition of
the device before treatment. Checking
device status before the treatment. Always
check that there is no water underneath
the device. Before every treatment, always
check that the device works perfectly and
that the accessories are efficient. DO NOT
use the device and its accessories if damage
is apparent. Contact Piezosurgery Inc. if the
abnormalities concern the device.
CAUTION : The wiring systems in the
room in which the device is installed and
used must comply with applicable standards
and relevant electrical safety requirements.
CAUTION : To avoid risk of electric shock,
this device must only be connected to power
grids with protective earth.