3 Contraindications, Warnings, and Precautions
ADJACENT STRUCTURES
Epic X 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.
SUCTION
Use high-speed suction as required to maintain a clear field of vision during treatment. Do not fire the
laser 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.
CAUTION: Laser plume may contain viable tissue particulates.
TREATMENT, TECHNIQUE, AND SETTINGS
Use your clinical judgment to determine all aspects of treatment including, but not limited to, the laser
treatment protocol, technique, power settings, pulse duration and interval settings, mode of
operation, as well as the accessories utilized (e.g. tip type) and other procedural requirements.
Closely observe and monitor clinical effects and use your judgment to determine the clinical
parameters and approach for the treatment. Make appropriate power, pulse length, and interval
adjustments to compensate for varying tissue compositions, density, and thickness. Always start
treatment at the lowest power setting for the specific indication and increase as required. BIOLASE
assumes no responsibility for parameters, techniques, methods or results.
CLINICAL ENVIRONMENT
Only use this device in clinical environments that observe proper standard aseptic techniques with all
oral procedures.
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