General Safety Considerations - Gemini 810 User Manual

GENERAL SAFETY CONSIDERATIONS

GUIDELINES
Safe use of the Gemini 810 + 980 diode laser is the responsibility of the entire dental team including
the doctor, any system operators, and the dental office safety officer.
MARKETING REQUIREMENTS REGARDING MEDICAL DEVICE
SAFETY (USA)
The United States Food and Drug Administration (FDA) has control over the sale and use of all
medical devices including the Gemini 810 + 980 diode laser. Manufacturers of products subject to
performance standards under the Federal Food, Drug, and Cosmetic Act, Chapter V, Subchapter C
- Electronic Product Radiation Control are required to certify compliance with the regulations and
furnish various reports to the Center for Devices and Radiological Health (CDRH).
For manufacturers of medical lasers (such as the Gemini 810 + 980 diode laser system), additional
review by the FDA of the safety and effectiveness of the device is required. Companies who intend
to market a medical laser or equivalent device must receive authorization from the FDA before the
device is permitted into commercial distribution. The premarket notification (510k) process used
for the Gemini 810 + 980 diode laser system is applicable for devices that are documented to be
substantially equivalent to existing legally marketed Class II devices.
STATUTORY LICENSURE FOR DENTAL LASER USE
Usually, states or provinces do not have a specific licensure requirement for use of surgical laser devices
by dentists. Many states do, however, require hygienists who will be using lasers to attend licensure
training that includes both a lecture and hands-on experience.
The license applicants are then required to pass a proficiency test for certification prior to using lasers.
These courses are usually taught by members of the Academy of Laser Dentistry who possess instructor
credentials. Such training would be appropriate for use of the Gemini 810 + 980 diode laser system.
OSHA PROVISIONS
Worker safety is the responsibility of the employer and is regulated by OSHA (Occupational Safety
and Health Administration), a division of the U.S. Department of Labor. OSHA recognizes ANSI
standard Z136.1 as a source for analyzing safety with respect to medical lasers.
For more information, see OSHA Technical Manual (TED1- 0.15A) Section III, Chapter 6, 1999. A safety
program is recommended for the safety of your patients and office staff in connection with the use
of the aser. It is also recommended to check and comply with applicable state and provincial safety
and health organization requirements.
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