Ultradent Products GEMINIEVO 810 DIODE LASE, Руководство пользователя

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CAUTION: LASER FUME AND/OR PLUME MAY CONTAIN VIABLE
TISSUE PARTICULATES
GENERAL SAFETY CONSIDERATIONS
GUIDELINES
Safe use of the Gemini EVO 810+980 soft tissue laser is the responsibility of the entire dental team including the doctor, any
system operators, and the dental office safety officer. In order to properly assess the favorable conditions of treatment, below
is a pre-treatment checklist to help ensure treatment to your patient is safe:
• Ask the patient about allergy to local or topical anesthetics.
• Make sure the Laser Warning sign posted in the operating area.
• Make sure the patient and operator(s) are all wearing laser protective eyewear specific to Gemini EVO laser.
• Have the patient fill out an informed consent form for laser treatment. Form templates are typically available from your
laser training provider.
• If performing a non-surgical procedure, use an un-initiated fiber tip.
• If performing a surgical procedure, use an initiated fiber tip.
Adjust the laser power settings as needed to fit the clinical circumstances of the case. The preset procedure settings built into
Gemini EVO laser are simply a manufacturer’s recommendation. Optimal power level may vary case by case
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 EVO 810+980 soft tissue 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 EVO 810+980 soft tissue 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 EVO 810+980 soft tissue 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 EVO 810+980 soft tissue 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.