Mectron Piezosurgery plus Mode D'emploi Et D'entretien page 12

1.4 Safety Requirements
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.
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WARNING: Check the condition of
the device before treatment. Always make
sure that there is no water under the device.
Before each treatment, always check that
the device is in proper working order and
that the accessories are efficient. Do not
carry out the treatment if any problems
are encountered in operating the device.
If experiencing problems with the device,
contact an Authorised Mectron Service
Centre.
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.
WARNING: When the peristaltic
pump cover is open, the foot pedal of
PIEZOSURGERY® plus must not be pressed.
Moving parts may injure the operator.
WARNING: Personal injury. Take care
to ensure that cables do not hinder the free
movement of personnel.
CAUTION: US Federal Law (of the United
States of America) restricts this device to sale
by or on the order of a physician.
WARNING: Before each use, examine
each part looking for any damages. If
damages are found, do not use.
WARNING: Do not activate the device if
the handpiece is faulty, damaged or broken.
Replace the handpiece immediately.
WARNING: Only use original Mectron
accessories and spare parts.
CAUTION: No changes can be made to
this device.