Biolase Inc. EPIC Manuale Utente
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P a g e
5 4 0 0 3 2 1 R e v . X : D R A F T
Contraindications
All clinical procedures performed with EPIC 10 must be subjected to the same clinical
judgment and care as with traditional techniques. Patient risk must always be considered and
fully understood before clinical treatment. The clinician must completely understand the
patient's medical history prior to treatment. Exercise caution for general medical conditions
that might contraindicate a local procedure. Such conditions may include allergy to local or
topical anesthetics, heart disease (including pacemakers), lung disease, bleeding disorders,
sleep apnea or an immune system deficiency, or any medical conditions or medications that
may contraindicate use of certain light/laser type sources associated with this device. Medical
clearance from patient's physician is advisable when doubt exists regarding treatment.
Warnings and Precautions
Prescription Statement
Federal law restricts this device to sale by or under the order of a licensed medical or dental
practitioner.
Eyewear
Doctor, patient, assistant and all others inside the operatory must wear appropriate laser
eyewear protection for the diode laser wavelength of 940 ± 10nm.
Anesthesia
In soft tissue cases anesthesia may not be required, but patients should be closely monitored
for signs of pain or discomfort at all times. If such signs are present, adjust settings, apply
anesthesia or cease treatment if required.
Adjacent Structures
EPIC 10
All clinical procedures performed with EPIC 10 must be subjected to the same clinical
judgment and care as with traditional techniques. Patient risk must always be considered and
fully understood before clinical treatment. The clinician must completely understand the
patient's medical history prior to treatment. Exercise caution for general medical conditions
that might contraindicate a local procedure. Such conditions may include allergy to local or
topical anesthetics, heart disease (including pacemakers), lung disease, bleeding disorders,
sleep apnea or an immune system deficiency, or any medical conditions or medications that
may contraindicate use of certain light/laser type sources associated with this device. Medical
clearance from patient's physician is advisable when doubt exists regarding treatment.
Warnings and Precautions
Prescription Statement
Federal law restricts this device to sale by or under the order of a licensed medical or dental
practitioner.
Eyewear
Doctor, patient, assistant and all others inside the operatory must wear appropriate laser
eyewear protection for the diode laser wavelength of 940 ± 10nm.
Anesthesia
In soft tissue cases anesthesia may not be required, but patients should be closely monitored
for signs of pain or discomfort at all times. If such signs are present, adjust settings, apply
anesthesia or cease treatment if required.
Adjacent Structures
EPIC 10
is designed to remove soft tissues. Therefore, always be aware of adjacent
structures and substructures during treatments. Be extremely careful not to inadvertently
penetrate or ablate underlying or adjacent tissues. Do not direct energy towards hard tissues
such as tooth or bone. Do not direct energy towards amalgam, gold or other metallic surfaces.
Do not direct energy towards cements or other filling materials. Exercise extreme caution
when using this device in areas such as pockets, cavities or channels such as 3
penetrate or ablate underlying or adjacent tissues. Do not direct energy towards hard tissues
such as tooth or bone. Do not direct energy towards amalgam, gold or other metallic surfaces.
Do not direct energy towards cements or other filling materials. Exercise extreme caution
when using this device in areas such as pockets, cavities or channels such as 3
rd
molar
sockets, where critical structures (i.e. nerves, vessels) could be damaged. Do not proceed
with using the laser if visibility is limited in these areas.
Suction
Use high-speed suction as required to maintain a clear field of vision during treatment. Do not
use the EPIC 10 if you cannot clearly see the treatment site.
Plume Removal
with using the laser if visibility is limited in these areas.
Suction
Use high-speed suction as required to maintain a clear field of vision during treatment. Do not
use the EPIC 10 if you cannot clearly see the treatment site.
Plume Removal
Special care must be taken to prevent infection from the laser plume generated by
vaporization of virally or bacterially infected tissue. Ensure that appropriate protective
equipment (including high-speed suction to remove the plume, appropriately filtered masks,
and other protective equipment) is used at all times during the laser procedure.
vaporization of virally or bacterially infected tissue. Ensure that appropriate protective
equipment (including high-speed suction to remove the plume, appropriately filtered masks,
and other protective equipment) is used at all times during the laser procedure.
Section 6: CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS