7
people including the patient, present in the treatment area
during lasing.
• Safety Eyewear: While using the Precise® LTM laser, doctors,
auxiliary staff, patients, and anyone attending them in the
operatory must wear the laser glasses provided with the
Precise® LTM system, which is appropriate for use with this
type of device. If additional glasses are obtained, they must
have the same specications for wavelength and optical
density as the glasses provided with this equipment. Never
point the laser tip directly at the face, eyes or skin of anyone
while emitting energy. The aiming beam is also capable of
causing eye damage.
• Test Firing the Laser: Always test-re the Precise® LTM prior to
using it intra-orally. Using a power of 1 Watt continuous wave
or less, place the laser in the ready mode. Then, activate
the laser for 1 - 2 seconds while aiming the ber onto a 2 x 2
gauze sponge moistened with water. Do not use alcohol or
any other combustible material to moisten the 2 x 2 sponge
as it may ignite.
•
Fiber Preparations: After cleaving and stripping the ber,
photo-initiation of the ber tip will allow the operator to remove
tissue more rapidly when contact procedures are indicated.
Gingival debris on the tip will retain the heat and it should be
removed. The tip will also begin to blacken and deteriorate
as it retains the heated debris and can break if not removed
by cleaving it. Clean the tip often using a 2 x 2 gauze sponge
moistened with water. Do not use combustible liquids to moisten
the 2 x 2.
•
Danger - Laser In Use Signage: Each operatory where the
Precise® LTM is used should have a “Laser In Use” sign placed
at the operatory entrance when a procedure is in progress.
This signage will help to reduce occurences of eye damage
caused by inadvertent exposure to laser energy. See Figure
40 on page 13.
•
Sharps Disposal and Sponge Removal: Remove cleaved ber
remnants and place them into a sharps container for disposal.
All sponges used for cleanup of lasers and bers should be
disposed of in a bag for contaminated soft products.
•
Plume Evacuation: Use high volume evacuation
suction during procedures to remove laser smoke or
‘plume’ debris. Use masks suitable for viral ltration.
Caution - laser plume may contain viable tissue particulates.
•
Key Switch: When the key switch is in the ON position (turn
clockwise to the right so it is 90 degrees in the vertical position),
the laser has been enabled and can be activated while in the
READY status. When not in use, insure that the key has been
turned off or that the laser is placed in the STANDBY status.
• Safety Education: Provide comprehensive safety procedure
training for all ofce personnel and include the staff in all outside
laser courses when possible. Be certain that all members of the
dental team understand how the laser works and can advise
patients as to their safety and advantages over conventional
procedures.
•
Laser Security: To prevent the unauthorized use of the laser
while not in use, the key should be removed from the unit and
maintained by the LSO.
•
Laser Stop Options: Any of these mechanisms can be used to
shut down the emission of laser energy in a real or perceived
emergency.
1. Foot Pedal – remove your foot to stop lasing
2. Engage the laser stop button
3. Key – turn off the key
4. Switch the Power to the off position (O)
5. Power Cord – unplug from the wall outlet
•
Hard Tissue Procedures: The Precise® LTM diode is not an
appropriate laser for hard tissue procedures. The diode laser
is attracted to melanin, hemoglobin and to some extent, to
water and oxygenated hemoglobin. Avoid prolonged exposure
of the energy when working in and around the cervical areas
of the tooth. Due to the thin layer of enamel in this area, the
laser’s energy may be absorbed by the hemoglobin in the
pulp and pulpal hyperemia may occur. Extended exposure to
laser energy could lead to pain and possible pulpal necrosis.
3.0.2 Laser Safety Program and Continuing Education
We recommend implementation of a Laser Safety Program
appropriate for your dental ofce. The plan may include the
following:
•
Delegation of authority and responsibility for supervision and
control of the laser to a designated LSO.
• Minimum Training requirements for users of the laser.
• Laser security against unauthorized use of the laser.
•
Standard operating procedures to regulate the work environment
in order to protect the patient and ofce staff from laser hazards.
The safe use of a laser is the responsibility of the (LSO) who can
be a full or part-time employee or the laser operator. It is their
responsibility to train the staff, maintain records concerning training
and the laser’s performance, perform safety checks, and prepares
the laser for use on a daily basis. The LSO must keep records of any
incidents that relate to the failure of the laser or any adverse effects
related to laser therapy and report such incidents as prescribed
by law. The laser safety ofcer assures that a medical follow-up
has been sought or has occurred following any adverse incident
during treatment. The LSO is responsible for the training of all ofce
personnel who are involved with the laser preparation and use.
Daily checks of the facility and equipment are also the LSO’s
responsibility. The LSO should test re the laser each day prior to
beginning each treatment procedure. For more information on
the contents of a Laser Safety Plan, you can review ANSI Standard
Z136.3 for Safe Use of Lasers in Health Care Facilities or TR IEC
60825-8 Guidelines for the Safe Use of Medical Laser Equipment.
The LSO should insure that the operator and staff attend laser
courses taught by qualied laser educators. Ongoing reviews of
laser safety procedures should be a part of normal ofce routine.
3.0.3 Food and Drug Administration
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 medical laser manufacturers, additional
review by the FDA of the safety and effectiveness of the device
is required. Companies who intend to market a medical laser
today must receive authorization from the FDA to permit the
device into commercial distribution. There are two forms of
premarket clearance procedures. The premarket notication
510(k) procedure is principally used for those devices that are
documented to be substantially equivalent to legally marketed
Class I and Class II devices. For new devices not equivalent to
legally marketed devices, a more complex
PMA is required.
To Next Page
Loading...