Cutera Excel V+, Руководство оператора, Страница: 81 / 112

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EXCEL V+ OPERATOR MANUAL
D2325, REV A, 2/19
S
afety and
R
egulatory
Introduction
The excel V+ system, 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 understanding of the
system and safety features as described in this Operator Manual.
Users must take precautions to prevent exposure of 532 nm and 1064 nm 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
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 532 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, ANSI Z136.1 or
European Standard EN 60825:2014, Annex A.
The excel V+ 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.