8501-00-1800, Revision 05
Confidential
B-1
Appendix B:
Candela Corporation
AlexTriVantage Laser System
Treating the Patient
Training Requirements
The Candela AlexTriVantage Laser is intended for use only by trained and qualified
physicians. This portion of the manual describes clinical techniques developed by experts in
the field, and is presented as a reference.
DO NOT rely solely on this information, or this manual, in lieu of formal training in the use of
the Q-Switched Alexandrite Laser (AlexTriVantage Laser).
Generally, no anesthesia is required for this procedure. If circumstances require its use, local
anesthesia may be administered.
Determining the Therapeutic Energy Level
The following summarizes the clinical techniques used and established by experts in the
field.
1.
Applying a Test Dosage
Optimum therapeutic energy density is dependent upon the tattoo or pigmented lesion
and individual variations that occur from patient to patient. For example, optimum
dosage for the treatment of a tattoo can depend on the origin of the tattoo (amateur,
professional, or traumatic), the depth of pigment and the patient's skin type. To
determine the correct therapeutic energy density, first test one or more sites on the
lesion area with low energy density(ies) (5.5 to 6.5 J/cm2).
Energy settings above 12 J/cm2 are considered investigational and are not
recommended.
Caution:
Because of variations in age, the skin color of the patient, and the type or
site of the tattoo or pigmented lesion, the physician should evaluate patient
response using test sites. The patient should be treated with the lowest energy
density that produces clearance of the test site.
Avoid retreating the same area when increasing the energy density to determine the
therapeutic threshold.
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