1.4
Safety Precautions
WARNING: Risk of explosion.
The device cannot operate in environments
where the atmosphere is saturated with
flammable gases (anaesthetic mixtures,
oxygen, etc.).
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'. The interval for periodic checks,
in the intended operating conditions and
described in this "Use and Maintenance"
manual, is one year.
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.
4
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® white 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 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: Before each use, examine
each part looking for any damages. If
damages are found, do not use.