Part Number: 0160-6411, Rev A, 02/2019 Page 221 of 314
Software Release: cOS 5.00
6 Safety and Regulatory
This chapter addresses the following major topics:
• 6.1 General Safety and Regulatory Information, page 221
• 6.2 Ocular Protection, page 222
• 6.3 Definitions from ANSI Z136.1-2007, page 223
• 6.4 Electrical Hazards, page 224
• 6.5 Fire Hazards, page 224
• 6.6 Protecting Non-target Tissues, page 224
• 6.7 Regulatory Compliance Safety Features, page 225
• 6.8 System Labels, page 227
6.1 General Safety and Regulatory Information
The CATALYS® Precision Laser System is a Class II ophthalmic surgical laser system as defined by
regulation number 21 CFR 886.4390.
OPTIMEDICA laser systems are precision medical instruments. The systems have undergone
extensive testing. With proper handling, they are useful and reliable clinical instruments. To
protect operating personnel and patients, this manual should be read thoroughly and
understood before operation.
OPTIMEDICA lasers are classified as Class 4 lasers by the National Center for Devices and
Radiological Health. Class 4 represents the highest power lasers; for this reason, you must take
precautions to prevent exposure of laser energy to the eye and skin from either direct or
diffusely reflected laser beams, except as an intentional application. In addition, precautions
must be taken in the surgical environment to prevent the hazards of fire and electrical injury.
OPTIMEDICA does not recommend specific clinical practices. The following precautions are
extensive but may not be complete. Laser users are advised to supplement this information with
technological advances in surgical products and techniques as they become available to the
medical laser user community through medical literature. See also the American National
Standard (ANSI®) publications ANSI Z136.3-2005 “American National Standard for the Safe Use
of Lasers in Health Care Facilities” and ANSI Z136.1-2007 “American National Standard for the
Safe Use of Lasers”, as well as the International Organization for Standardization (ISO)
publication ISO 15004-2:2007 Ophthalmic Instruments – Fundamental requirements and test
methods – Part 2: Light Hazard Protection and other national standards as may be applicable for
the country in which the system is used.
Calculations regarding the use of lasers have defined a safe range of operating parameters, per
ISO 15004-2:2007.
To Next Page
