Safety Precautions - Mectron PIEZOSURGERY touch Mode D'emploi

01.4 Û 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 flammable mixtures
EN
are present.
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 accessories
are efficient. In case you 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® touch must not
be 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
6
the instructions given in the Cleaning and
Sterilization Manual.
WARNING: Infections control.
To ensure maximum safety of the patient
and the operator, before using all the
reusable parts and accessories, make sure
you have first cleaned and sterilized them,
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, the
cutting efficiency decreases; re-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.