Facility & Environmental Considerations; General Safety Considerations - Gemini 810 DIODE LASER Manual Del Usuario

FACILITY & ENVIRONMENTAL CONSIDERATIONS
GUIDELINES
In addition to receiving proper training in the use of soft-tissue dental lasers, users should be familiar and experienced with these procedures using electrosurgical devices or traditional instruments
before performing them on patients with the Gemini 810 + 980 diode laser. Non-experienced users should seek appropriate training guidance before attempting clinical treatments with the Gemini laser
unit.
In order to ensure the safe use of the Gemini 810 + 980 diode laser in your facility, please check to make sure that the proposed location is compatible with the specifications listed below.
POWER REQUIREMENTS
External AC/DC Power Supply:
Input Power-110–120 VAC @ 60 Hz 700mA; 220-240 V AC @ 50Hz 350mA
Output Power–6.0W + 13V DC at 4A maximum
HEATING AND VENTILATION
Operating environmental conditions to be within 10°-40°C (50°-104°F), and 95% relative humidity or less. Transportation and storage environmental conditions to be within-20° to 50°C (-4°to 122°F), and
relative humidity of 10% to 95% or less. Atmospheric pressure to be within 50kPa–106kPa in operating, transportation and storage conditions.
COMBUSTIBLE CHEMICALS AND GASES
All gases that are combustible or support combustion and are used in the operatory area where the Gemini 810 + 980 diode laser is being operated must be turned off during the procedure. Cleaning
supplies or other flammable chemical compounds should be stored in an area away from the surgical site in order to avoid possible combustion. Do not use in the presence of supplemental therapeutic
oxygen supplies for patients with respiratory or related diseases.
PLUME EVACUATION
Plume evacuation should be addressed when vaporizing tissues. A high volume vacuum system should be used and 0.1 micron or less high filtration masks that are suitable for virus and bacterial control
should be worn by clinicians.
OPERATORY ACCESS DURING LASER USE
Access to the treatment area should be restricted while the lasers are in use. A sign indicating "LASER IN USE" should be placed in a designated area adjacent to the treatment area entry location.

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 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.
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 laser. It is also recommended to check and comply with applicable state and provincial safety and health organization requirements.
CSA PROVISIONS
This device is to be installed and operated according to the Canadian Standards Association CAN/CSA-Z386-08 provision for the safe use of the entire laser apparatus. This standard provides guidance
for the Health Care Laser System (HCLS), and is intended for use by all personnel associated with the installation, operation, calibration, maintenance, and service of the HCLS. This standard includes
engineering, procedural and administrative controls, and laser safety training necessary for the safety of patients and health care professionals.
CONTRA-INDICATIONS
Exercise caution for general medical conditions that might contra-indicate a local procedure. Such conditions may include allergy to local or topical anesthetics, heart disease, lung disease, bleeding
disorders, and immune system deficiency, or any medical conditions or medications that may contra-indicate use of certain light/laser type sources associated with this device. Medical clearance from
patient's physician is advisable when doubt exists regarding treatment.
The Gemini 810 + 980 diode laser is not indicated for hard tissue procedures. The Laser is attracted to melanin, hemoglobin, and, to some extent, water. Avoid prolonged exposure ofthe energy when
working in and around the cervical areas of the tooth. Due to the thin layer of enamel in this area, energy may be absorbed by the hemoglobin in the pulp and pulpal hyperemia may occur. Extended
exposure to such energy could cause patient discomfort and even lead to possible pulpal necrosis.
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