Cutera GenesisPlus, Operator'S Manual, Page: 51 / 80

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GenesisPlus Operator Manual
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S
afety and
R
egulatory
Introduction
GenesisPlus, when properly used by trained personnel, is a safe and effective instrument for
indicated clinical treatments. Keep in mind that safe operation requires a thorough understand-
ing of the system and safety features as described in this Operator Manual.
Users must take precautions to prevent exposure of Nd:YAG laser energy to the eyes and skin
from either direct or diffusely reflected light, except as a therapeutic application. Additional
precautions must be taken to prevent fire, electrical injury and explosion.
Cutera does not make recommendations regarding the practice of medicine. Treatment param-
eters are provided as a guide. Individual treatments should be based on clinical training, clini-
cal observation of laser-tissue interaction and appropriate clinical endpoints.
Optical Hazard
Laser safety eyewear is routinely required with most laser systems. Personnel responsible for
laser safety should determine the need for safety eyewear based on the Maximum Permissible
Exposure (MPE), Nominal Hazard Zone (NHZ), the Nominal Ocular Hazard Distance
(NOHD) and the optical density (OD) for the 1064 nm Nd:YAG wavelength and the configu-
ration of the treatment room (usually within the controlled area). For additional information,
refer to ANSI Z136.3-2005, ANSI Z136.1-2007 or European Standard EN 60825:2007,
Appendix A.
The GenesisPlus system is a Class IV Laser Product as defined by the U.S. Code of Federal
Regulations and a Class 4 Laser Product as defined by the European Communities Medical
Devices Directive.