Safety Requirements - mectron Piezosurgery Plus Use And Maintenance Manual

01.4

SAFETY REQUIREMENTS

WARNING: MR-UNSAFE
The Piezosurgery Plus MUST NOT BE
USED in a Magnetic Resonance (MR)
environment .
WARNING: Risk of explosion.
The device cannot function in places
where there is an atmosphere saturated
with flammable gases (anaesthetic
mixtures, oxygen, etc .) .
WARNING: Contraindications.
Interference with other equipment.
Although PIEZOSURGERY
with standard IEC 60601-1-2, it may
interfere with other equipment located
nearby . PIEZOSURGERY
used near, or stacked on other equipment .
Install PIEZOSURGERY
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
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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 IEC
62353 "Medical Electrical Equipment
- recurrent test and test after repair of
medical electrical equipment" .
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 .
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plus complies
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plus must not be
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plus at a safe
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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 the
PIEZOSURGERY plus must not be pressed .
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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
Piezosurgery/ Mectron accessories and
spare parts .
CAUTION: No changes can be made
to this device .
WARNING: The removable panel
on the back of the device can only be
accessed by authorised Piezosurgery Inc .
personnel . Users must not attempt to
remove it or tamper with it as this would
invalidate the warranty and may damage
the device .
WARNING: Contraindications. Do
not use the PIEZOSURGERY
patients fitted with pace-makers or other
implantable electronic devices . This also
applies to the operator .
plus on
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