Safety Requirements - mectron Compact Piezo LED Installationsanleitung

COMPACT PIEZO LED
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
COMPACT PIEZO LED 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,
COMPACT PIEZO LED may interfere with
other devices in the vicinity.
WARNING: Risk of explosion. The
appliance cannot operate in environments
where the atmosphere is saturated with
flammable gases (aesthetic mixtures, oxygen,
etc.).
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: No modification is allowed to
this appliance.
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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: 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
page 19 of the Use and Maintenance
Manual.
WARNING: Infection control.
For maximum patient and operator safety,
before using all the parts and reusable
accessories, make sure they have been
previously cleaned and sterilised by following
the instructions in Chapter 6 on page 19
the Use and Maintenance Manual.
CAUTION: Contraindications. After
having autoclaved the handpiece, inserts,
torque wrench or any other sterilisable
accessory, wait for them to completely cool
down before reusing them.
WARNING: Exclusively use original
MECTRON inserts, accessories and spare
parts.
WARNING: In case of an adverse event
and/or accident attributable to the device
during correct use and in accordance with
the intended use, a report must be made to
the Competent Authority and manufacturer
indicated on the product label.
Chapter 6 on
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