Fraxel
®
1550, Fraxel 1927 and Fraxel DUAL 1550/1927 Laser System
Part Number 10-05170 Rev. O
Page 59 of 92
3.9 Regulatory
Compliance
and Device Safety Information
3.9.1
Features
The Fraxel Laser Systems provide a means for setting and measuring the
laser output of each laser source, and also contains the required interlock
connectors, key control, and labeling.
3.9.2
Emergency Stop Button
The laser has an emergency stop button that, when pushed, turns off (de-
energizes) the laser in emergency situations.
3.9.3
Key Control
The key switch must be turned to the “ON” position to allow the laser to be
energized. Laser light can be produced by the system only when the key
switch is on. The key may not be removed while the key switch is in the “ON”
position.
3.9.4
Touch Screen Display
Allows the operator of the laser to calibrate the laser prior to use, set the
system and treatment parameters prior to treatment, simulate treatment,
manage tip usage, and perform treatments.
3.9.5
Laser Emission Indicator
After a self-test, treatment can only begin when the laser is in the “Treat”
mode. The laser also emits an audible sound when the laser is pulsing.
3.9.6
The laser can only fire when the following conditions are met:
a) The tip is installed correctly, and
b) The footswitch is depressed, and
c) The handpiece senses motion when the handpiece tip is placed
in contact with the skin.
3.9.7
Handpiece Connection
The electrical connections providing power to the handpiece are completely
enclosed by the console and umbilical. There is no access to electrical
sources form the console to the handpiece. The optical path comprising the
laser energy conduit from the console to the handpiece is completely and
redundantly enclosed from the source to the handpiece window.
3.9.8
Foot Pedal Connector
The Foot Pedal connector allows the Foot Pedal supplied with the system to
be connected to the main unit.
