Fraxel
®
1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System
Part Number 10-05170 Rev. O
Page 46 of 92
3.0 Safety
The following Fraxel systems are each classified as Class 4 lasers according to Center for
Devices and Radiological Health (CDRH) and IEC / EN regulations: Fraxel 1550, Fraxel
1927 and the Fraxel DUAL 1550/1927 Lasers. This classification represents the highest
power laser. Users and staff must take precautions to prevent exposure of laser energy to
the eye and/or skin from either direct or diffusely reflected laser beams. In addition,
precautions must be taken in the surgical environment to prevent hazards of fire and
electrical injury.
This section discusses the primary safety concerns when operating the both Fraxel 1550,
Fraxel 1927 and Fraxel DUAL 1550/1927 Laser Systems. The instructions are intended to
raise awareness of the safety issues and provide insight so that hazardous optical,
mechanical, electrical, and chemical risks may be minimized.
CAUTION: Prior to use of the Fraxel Laser Systems, this manual must be thoroughly
read and understood by the personnel involved with operating the System. Improper
use may cause personal injury and damage to the System and may invalidate any
warranty agreement.
CAUTION: Improper service, repair or modifications performed by unauthorized
personnel may pose a hazard and will invalidate any warranty agreement.
CAUTION: United States Federal law restricts this device to sale by or on the order of
a physician.
CAUTION: The availability of electronic alarms does not relieve operators of their
obligation to carefully monitor the entire system during operation. CAUTION: Laser
plumes may contain viable tissue particles.
Although the Solta system is a contact non-ablative system which normally cannot
produce any smoke or plume, any laser plume (debris) generated by the laser is
potentially hazardous. It may obscure the laser operating field and may contain
viable airborne pathogens. Any plume generated as part of a laser procedure must
be evacuated promptly and effectively. If such plumes are observed during normal
operation of the laser as instructed by this manual and as directed in the Solta
training, immediately stop treating, shut off the laser system and contact Solta
Customer Service
