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Cutera GenesisPlus - Expected Transient Events and Possible Adverse Effects; Clinical Guidelines

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61
GenesisPlus Operator Manual
D1151, R
EV C, 10/16
Expected Transient Events and Possible Adverse Effects
Erythema, edema and purpura may occur following treatment and typically resolve
within one month.
Hyperpigmentation, hypopigmentation, burns, erosion or blistering may occur, some
of which may result in scarring. These complications are usually due to the use of
excessive energy levels.
Deep tissue injury and prolonged wound healing may occur when treating warts.
GenesisPlus should only be operated by qualified personnel who have received appropriate
training. In addition to the information provided in the Safety and Regulatory section, the fol-
lowing safety precautions are recommended during use of the system:
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, be sure to fit the
patient with opaque eye protection that will completely block light to the eyes. The
eyewear must provide adequate protection from 1064 nm Nd:YAG laser radiation.
See the Safety and Regulatory section 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.
WARNING
Never allow anyone near the system while the system is in use
without proper protective eyewear. Unprotected laser exposure
could cause permanent eye damage.
Clinical Guidelines
WARNING
It is essential that all safety precautions as recommended in this
manual be carefully observed, especially with respect to the wear-
ing of protective eyewear by the patient, practitioner, and attending
staff. In addition, the development of eye-hand-foot coordination
while using the laser system’s handpiece and footswitch is import-
ant to avoid inadvertent laser operation when the handpiece is
removed from the target tissue.

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