- 3 -
Operator Training
The POLYLASE MX Pulsed Dual Output Laser:
Caution: In the United States, federal law restricts this device to sale by or on the order of
a physician or any practitioner by state law to use or order the use of this device.
It is to be used by those trained in the safe handling and operation of this system. It is
recommended that, in addition to laser safety training of all operation room or clinic
personnel, the user/institution adopt a training and safety program as outlined in the latest
revision of the ANSI Standard Z-136.3, the American National Standard for the Safe Use
of Lasers in Health Care Facilities.
It is further suggested that practitioners desiring privileges for laser use should obtain
approval from the appropriate credential issuing body within their respective institutions.
Practitioners should consider the following training avenues:
1.
An accredited training course within the practitioner’s specialty,
2.
“Hands-on training under the preceptorship of a qualified used,
3.
Attendance at specialty-specific courses presented during academy or college
meetings.
All practitioners handling lasers, including physicians, nurses and other allied
professionals, should also complete a training program which may include subjects such
as basic laser physics, laser safety, tissue interaction, laser operating procedures, laser set-
up procedures, potential hazards, and hands-on experience.
In-service training in the use of the POLYLASE MX Pulsed Dual Output Laser will be
provided near the time of the initial system installation. Clinical techniques described
here are presented only as a reference based on clinical experience with the device and
other laser devices reported in the published literature.
Indications for Use
The POLYLASE MX Pulsed Dual Output Alexandrite and Nd:YAG Laser indication for
use is based upon the selective absorption of natural chromophores, particularly melanin.
The Alexandrite Laser wavelength of 755 nanometers and Nd:YAG Laser wavelength of
1064 nanometers is well absorbed by this chromophore.
Indication for use:
The POLYLASE MX Pulsed Dual Output Laser is designed to effect hair removal of
patients with skin types I-VI through selective targeting of melanin in hair follicles.