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EXCEL HR OPERATOR MANUAL
D1796, REV. D, 12/16
Safety and Regulatory
Introduction
Cutera lasers and handpieces, when properly used by trained personnel, are safe and effective
instruments for indicated clinical treatments. Keep in mind that safe operation requires a thorough
understanding of the system and safety features as described in this operator manual.
Users must take precautions to prevent exposure of 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 parameters are
provided as a guide. Individual treatments should be based on clinical training, clinical observation of
laser-tissue interaction and appropriate clinical endpoints.
Optical Hazard
Safety eyewear is routinely required with most lasers. 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
755 nm and 1064 nm wavelengths and the configuration 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 60825-1:2014, Annex A.
Cutera laser systems are Class IV Laser Products as defined by the U.S. Code of Federal Regulations
and Class 4 Lasers as defined by the European Communities Medical Device Directive.
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