Introduction 9
Selecta
PBL200051, Rev J
Introduction
The Selecta ophthalmic laser systems are classified as Class IIIb lasers by the
Center for Devices and Radiological Health of the Food and Drug
Administration and as Class 3b by the International Standard IEC 60825.
Users must take precautions to prevent exposure of laser energy to the eyes
and skin from either direct or diffusely reflected laser beams, except as a
therapeutic application. Additional precautions must be taken to prevent fire,
electrical injury, and explosion.
Lumenis does not make recommendations regarding the practice of medicine.
Laser treatment parameters are provided as a guide. Individual treatment
should be based on clinical training, clinical observation of laser-tissue
interaction, and appropriate clinical endpoints.
See the American National Standard (ANSI) publications Z136.3-2005,
ANSI Z136.1-2000, and EN 207 for recommendations on the safe use of
lasers in health care facilities.
This package conforms to the conditions and limitations specified in US federal
regulations, title 49 CFR 173.426 for radioactive material, excepted package-
articles manufactured from natural thorium, UN 2910.
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