Candela AlexTriVantage, Operator'S Manual

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8501-00-1800, Revision 05 Confidential A-1
Appendix A:
Candela Corporation AlexTriVantage Laser System
Pre-Treatment Visit
General
At the first visit the physician obtains a detailed patient history and examines the tattoo for
suitability of Q-Switched Alexandrite Laser therapy. The physician typically determines why
the patient is seeking treatment and what expectations the patient has formed regarding the
outcome of treatment. He/she then discusses treatment options with the patient, including
AlexTriVantage Laser and other treatment modalities. This discussion gives the patient the
opportunity to explore the technique further and help decide whether to proceed with
AlexTriVantage laser therapy.
Counseling
During this first visit, the physician should inform the patient of the following:
1. Q-Switched Alexandrite Laser therapy may consist of multiple treatments given over many
months, with 4 to 8 weeks between treatment. Clinical evidence to date suggests that
epidermal lesions can usually be retreated within 4 to 6 weeks. Dermal lesion treatments
performed after 8 or more weeks have shown the most effective clearance.
2.
There may be discomfort/pain resulting from the treatment.
3.
Transient edema may occur immediately following laser therapy.
4.
Occasionally, pinpoint (punctate) bleeding at laser impact sites.
5.
A white-gray discoloration of the treatment area may appear immediately following
treatment and last for a few minutes to a few days. This may be replaced with an
erythema or purpura which may persist for several days. A scab may form at the
treatment area and drop off in 7-10 days. (It may be helpful to use an anti-bacterial
ointment on the treated area and to cover it with a dressing for a few days after
AlexTriVantage laser therapy. This will protect the skin from being abraded and the site
infected, a potential source of scar formation.)
6.
The treated area may not clear with the first treatment. The same area may be treated
more than once for the best results.
7.
Possible risk of adverse reactions, e.g., scarring, infection, and hypo- or
hyperpigmentation.