Safety Precautions - mectron compact piezo LED Installation Manual

• Breach of the requirements and the
information contained in
page 14 of the Use and maintenance
manual;
• Breach of the requirements and the
information contained in
1.4 Safety Precautions
WARNING: Contraindications.
Do not use the device on patients who
carry heart stimulators (Pace-makers) or
other implantable electronic devices. this
precaution also applies to the operator.
WARNING: Contraindications. Do not
perform scaling treatments without water
spray in order to avoid the insert tip over-
heating which may cause damages to the
tooth. treatments with no water spray can be
carried out only with "Dry Work" insert tips
which do not have the water passage.
CAUTION: Contraindications.
Ultrasonic scaler. Do not perform treatments
on prosthetic artifacts made of metal or
ceramics. the ultrasonic vibrations could lead
to the de-cementing of the artifacts.
WARNING: Contraindications.
Interference from other equipment.
an electrical scalpel or other electro-surgical
units near the compact piezo LeD device may
interfere with its correct operation.
WARNING: Contraindications.
Interference with other equipment.
Though compliant to the standard IEC 60601-
1-2, compact piezo LeD may nonetheless
interfere with other devices nearby.
compact piezo LeD must not be used near
to or stacked on other devices. However,
if this were to prove necessary, check and
monitor correct operation of the device in
that configuration.
WARNING: Risk of explosion. the
device cannot operate in environments where
the atmosphere is saturated with flammable
gases (anesthetic mixtures, oxygen, etc..).
chapter 4.5 on
• Unauthorized repairs in accordance with
Chapter 6 on
CAUTION: in case 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 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 is
once per year or every 2000 hours of use,
whichever condition is satisfied first.
WARNING: Checking device status
before the treatment. Before every
treatment, always check that the device
works perfectly and that the accessories are
efficient. In case of operating abnormalities,
Do Not perform the treatment. contact an
authorized piezosurgery inc. Service center if
the abnormalities concern the device.
WARNING: Cleaning and sterilising
new or repaired instruments. all the new
or repaired device accessories are not sterile.
At first use and after each treatment they
must be cleaned and sterilized by carefully
following the instructions in
page 17
manual.
WARNING: Diamond coated insert tips
are SINGLE USE ONLY. the diamond coated
insert tips are intended to be used on an
individual patient during a single treatment
procedure and then disposed of. the
diamond coated insert tips must be sterilized
only one time, prior the first use.
iNtRoDUctioN
page 17 of the Use and maintenance
manual;
the indications contained in
on page 36 of this manual.
of the Use and maintenance
Chapter 7.3
Chapter 6 on
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