Safety Requirements - Mectron Piezosurgery Plus Gebrauchs- Und Wartungsanleitung

1.4 Safety Requirements
WARNING: Risk of explosion.
PIEZOSURGERY plus, with accessories,
cannot operate in environments where the
atmosphere is saturated with flammable
gases (anaesthetic mixtures, oxygen, etc.).
WARNING: Interference with other
equipment. Thoug compliant with standard
IEC 60601-1-2, PIEZOSURGERY plus may
nonetheless interfere with other devices
nearby. PIEZOSURGERY plus, with relative
accessories, must not be used near to or
stacked on other devices. However, if this
were to prove necessary, you must check
and monitor correct operation of the device
in that configuration.
WARNING: Interference by other
equipment. An electrosurgical knife of
other electrosurgical devices near the
PIEZOSURGERY plus device and relative
accessories may interfere with its correct
functioning.
CAUTION: In case the final user,
operating in their own medical room or
surgery, in order to comply with mandatory
requirements, must periodically inspect the
equipment present in the surgery, the test
procedures to apply to medical electrical
equipment and medical electrical systems
for the safety assessment must be carried
out following the standard EN 62353
'Medical electrical equipment - Periodic
inspections and tests to be carried out after
repair of medical electrical equipment'. The
frequency of periodic inspections in the
intended conditions of use described in this
Use and Maintenance manual is once per
year.
WARNING: Check the condition
of the device and of the accessories
before treatment. Always make sure
that there is no water under the device
PIEZOSURGERY plus. Before each treatment,
always check that the device and its
accessories are in proper working order
and that its components are efficient. Do
not carry out the treatment if any problems
INTRODUCTION
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 any risk of electrical
shocks this device must be grounded.
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: Federal (US) law restricts the
marketing of this device to prescription or
licensed practitioner.
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
components and spare parts.
CAUTION: No changes to this device
nor to its accessories are allowed.
WARNING: The removable panel on the
back of the device can only be accessed by
authorised Mectron 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 plus and relative
accessories on patients fitted with pace-
makers or other implantable electronic
devices. This also applies to the operator.
CAUTION: Contraindications. Do
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