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Cutera Excel HR - Expected Transient Events and Possible Adverse Effects; Treatment Precautions

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69
EXCEL HR OPERATOR MANUAL
D1796, REV. D, 12/16
Expected Transient Events and Possible Adverse Effects
Erythema, edema and purpura may occur following treatment and typically resolve with
time.
Hyperpigmentation, hypopigmentation, burns, erosion, epidermal crusting or blistering may
occur
, some of which may result in scarring.
Temporary or permanent gray hair (leukotrichia) may develop.
Stimulation of terminal hair growth may occur within or adjacent to treated area.
Undesired hair loss in hair-bearing areas may result from treatment of vascular and benign
pigmented lesions.
Sun exposure/tanning beds/artificial tanning may increase the risk of unwanted side ef
fects
and adverse events.
Red rash/bumps
Hemosiderin staining
Textural changes/cutaneous indentations
Treatment Precautions
The excel HR should only be operated by qualified personnel who have received appropriate training. In
addition to the information provided in the Safety and Regulatory section of this manual, the following
safety precautions are recommended:
Guard against accidental exposure to laser energy.
Instruct all staff members to carefully aim the treatment beam only
at the targeted treatment
areas.
Ensure that the patient and all staff personnel in the treatment room wear appropriate
protective
eyewear. If the patient cannot wear protective eyewear, fit the patient with opaque
eye protection that will completely block light to the eyes. The eyewear must provide
adequate protection from laser radiation of the wavelength being used. See the Eye Safety
section in the Maintenance chapter for protective eyewear requirements.
Instruct all staff members and patients to never look directly at the laser light or reflective
surfaces, even when wearing proper protective eyewear
.
Never allow anyone near the system while the system is in use
without
proper protective eyewear. Unprotected laser exposure can
cause permanent eye damage.
WARNING

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