mectron COMPACT PIEZO LED - Safety Precautions

3
INTRODUCTION
• Breach of the requirements and the
information contained in Chapter 4.5 on
page 14 of the Use and Maintenance
Manual;
• Breach of the requirements and the
information contained in Chapter6on
page 17 of the Use and Maintenance
Manual;
• Unauthorized repairs in accordance with
the indications contained in Chapter7.3
on page 36 of this manual.
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conguration.
WARNING: Riskofexplosion. The
device cannot operate in environments where
theatmosphereissaturatedwithammable
gases(anestheticmixtures,oxygen,etc..).
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satisedrst.
WARNING: Checkingdevicestatus
beforethetreatment. Before every
treatment, always check that the device
works perfectly and that the accessories are
ecient.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rstuseandaftereachtreatmentthey
must be cleaned and sterilized by carefully
following the instructions in Chapter6on
page 17 of the Use and Maintenance
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rstuse.