Biolase Inc. EPIC-1 ユーザーズマニュアル
EPIC™10 User Manual
pg. 28
5400525 Rev B
6. CONTRAINDICATIONS, WARNINGS & PRECAUTIONS
6.1 CONTRAINDICATIONS
All clinical procedures performed with EPIC 10 must be subjected to the same clinical judgment
and care used 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.
and care used 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.
6.2 WARNINGS AND PRECAUTIONS
Prescription Statement
Prescription Statement
Federal Law restricts this device to sale by or on the order of a dentist or physician or other
licensed medical practitioner.
licensed medical 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.
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.
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 use. Be extremely careful not to inadvertently penetrate or ablate
underlying or adjacent tissues. Do not direct energy toward hard tissue 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 third 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.
and substructures during use. Be extremely careful not to inadvertently penetrate or ablate
underlying or adjacent tissues. Do not direct energy toward hard tissue 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 third 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.