5400230 Rev. H
2 Precautions and Warnings
2.1 CLINICAL
PRESCRIPTION REQUIRED
:
Federal law restricts this device to sale by or on the order of a dentist or
physician or licensed practitioner.
TRAINING REQUIRED
:
Only licensed professionals who have reviewed and understood this
User Manual should use this device
.
Additional training from a Biolase Authorized Representative is
strongly recommended.
CLINICAL USE:
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 pulse interval
settings, mode of operation as well as the tip type and other procedural requirements. Always start
treatment at the lowest power setting for that specific indication and increase as required. Closely
observe and monitor clinical effects and use your judgment to determine clinical parameters and
approach for the treatment. Make appropriate power and settings adjustments to compensate for
varying tissue compositions, density and thickness. Cutting with the iLase is a thermal process and
any transfer or accumulation of heat into adjacent structures may result in a burn and tissue
damage. Always start treatment at the lowest power setting for that specific indication and increase
as required. Be aware of the underlying and adjacent structures such as nerves and blood vessels
when cutting with this device. Do not direct laser energy towards hard tissues such as tooth or bone
or any metallic restorations. Do not direct laser energy towards metallic restorations, cements or
other dental materials. Exercise extreme caution when using this laser inside the pocket, 3
rd
molar
sockets, channels and other openings where visibility is limited.
ANESTHESIA:
When treating soft tissue, anesthesia may not be necessary; 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.
INEFFECTIVE REMOVAL OF TISSUE:
Ineffective removal of tissue may be caused by
improper tip
initiation (see Section 4.7) or reduction in the power output. Check with a Biolase service
representative to make sure that the iLase is functioning properly.
TIP BREAKAGE:
Use a bite block to prevent accidental biting and breakage of the tip; use
high-
speed suction to prevent patient inadvertently swallowing a broken tip and choking.
iLASE WINDOW:
Check and clean the protective window of the fiber optic shaft with a cotton swab
moistened with isopropyl alcohol.
CAUTION:
Failure to check and clean the window will lead to reduced
optical power efficiency and permanent damage to the system (refer to Section 7 for maintenance
information).
