Safety Precautions - mectron Piezosurgery white Wartungshandbuch

01.4

SAFETY PRECAUTIONS

WARNING: Do not install the
device in places where there is a risk
of explosion. The device cannot operate
in environments where anesthetic or
EN
CAUTION: In the case that the end
user, when operating in his or her own
medical study or clinic, must subject the
electro-medical equipment and systems
to periodical inspections in order to
adhere to imposed requirements, the
test procedures that must be applied to
electro-medical equipment and systems
to evaluate safety must be performed in
line with norm EN 62353 'Electro-medical
devices - Periodical inspections and tests
to be performed after repair interventions
on electro-medical devices'.
WARNING: 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
uncover operating abnormalities, do
not perform the treatment. Contact an
Authorized Mectron Service Center if the
abnormalities concern the device.
CAUTION: The electrical system of the
premises in which the device is installed
and used must be compliant to the norms
in force and to the relative electrical safety
precautions.
CAUTION: To avoid any risk of electric
shock this device must be grounded.
WARNING: When the lid of the
peristaltic pump is open, the foot pedal
of the PIEZOSURGERY
operated. The parts in movement may
cause harm to the operator.
WARNING: All the accessories of
the new or repaired devices are not
sterile. All new and repaired accessories
are supplied in non-sterile conditions.
Before use, and after each treatment, they
must be cleaned and sterilised in strict
compliance with the instructions given in
the Cleaning and Sterilization Manual.
6
white must not be
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WARNING: Infections control.
To ensure maximum safety of the patient
and the operator, before using all the
reusable parts and accessories, make sure
following the instructions of the Cleaning
and Sterilization Manual.
CAUTION: Contraindications.
Allow reusable, autoclavable items (the
handpiece, the inserts, the torque wrench,
and any other accessory that can be
sterilized ) to gradually return to room
temperature after steam sterilization and
prior to usage. The cooling process must
not be accelerated.
WARNING: Breakage and wear-out
of the inserts. High frequency oscillations
and wear-out may, in rare circumstances,
lead to the breakage of the insert.
Deformed or otherwise damaged inserts
are susceptible to breakage during their
use. These inserts must never be used.
If an insert breaks, check that none of its
fragments remain in the treated part and,
at the same time, apply effective suction
to remove them.
The patient must be instructed to breathe
through his nose during the treatment,
or a dental dam must be used to prevent
the patient from ingesting fragments of
broken inserts.
When the nitride coating wears out,
sharpening the insert damages it and is
therefore forbidden. Check that the insert
is not worn out. Use of a worn-out insert
reduces the cutting performance and can
cause necrosis of the bone surface treated.
During the intervention, frequently check
that the insert is intact, especially in its
apical part.
During the intervention, avoid prolonged
contact with retractors or with metallic
instrumentation in use. Do not exert
excessive pressure on the inserts during
their use.
WARNING: Only use original Mectron
inserts, accessories, and spare parts.