mectron MICROPIEZO, Use And Maintenance Manual

Page: 98 / 262

4
MICROPIEZO
1.4 Safety Requirements
WARNING : Contraindications .
Do not use the appliance on patients with
Pacemakers or other implantable electronic
devices. This regulation also stands for the
operator.
WARNING: Contraindications. Do not
perform scaling treatments without water
spray in order to avoid an overheating of the
insert that can cause damage to the tooth.
Treatments without water spray can only be
those performed with the "Dry Work" inserts
without water passage.
CAUTION: Contraindications. Ultrasonic
scaler. Do not perform treatments on metal
or ceramic prosthetics. Ultrasonic vibrations
could lead to decementation of the dentures.
WARNING: Contraindications.
Interference from other equipment.
An electrosurgical scalpel or other
electrosurgical units positioned near the
MICROPIEZO appliance may interfere with
the correct operation of the appliance itself.
WARNING: Contraindications.
Interference with other equipment. Even
if compliant with standard IEC 60601-1-2,
MICROPIEZO may interfere with other devices
in the vicinity. MICROPIEZO must not be
used near or stacked with other appliances.
However, if this should become necessary,
it is necessary to check and monitor the
correct functioning of the appliance in that
configuration.
WARNING: Risk of explosion. The
appliance cannot operate in environments
where the atmosphere is saturated with
flammable gases (aesthetic mixtures, oxygen,
etc.).
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 or
every 2000 hours of use, whichever condition
is satisfied first.
WARNING: Checking the condition of
the device before treatment.
Always check that there is no water under
the appliance. Before every treatment always
check the perfect operation of the appliance
and efficiency of the accessories. If operation
anomalies are observed do not carry out the
treatment. If the faults concern the appliance,
contact an Authorised MECTRON Service
Centre.
CAUTION: The electrical system of the
premises in which the appliance is installed
and used must comply with the rules in force
and the relevant requirements of electrical
safety.
CAUTION: To avoid the risk of electrical
shocks, this appliance has to be connected
exclusively to a power supply with an earth
safety device.
WARNING: Cleaning and sterilising
new or repaired instruments. All the new or
repaired appliance accessories are not sterile.
At first use and after each treatment they
must be cleaned and sterilised by carefully
following the instructions in Chapter 8 on
page 35 .