2.8 Safety Features of the System
The System incorporates the following safety features. All personnel operating the
System should be familiar with these features.
▪ The System has unique password to avoid device operation by non-authorized
personnel.
▪ The power electronics cannot be activated unless the applicator and Footswitch
have been connected to the System. With IPL, connection of the applicator is
sufficient.
▪ An audible tone indicates energy activation.
▪ During activation, the System performs a self-test of the hardware.
▪ Hardware is tested every 10ms to ensure proper operation of electrical circuit.
▪ Tissue impedance monitoring prevents accidental RF energy emission to the
patient.
▪ Skin surface is monitored during the treatment of Forma Handpiece. RF energy
delivery is terminated when skin temperature reaches the Cut-Off level.
▪ The System starts at a low setting.
▪ Temperature monitoring which disables system operation if the Handpiece
sapphire temperature is outside the operating range for, DiolazeXL, Vasculaze
and Lumecca Handpieces only.
The System with the DiolazeXL and Vasculaze Handpieces includes a comprehensive
monitoring system that allows operation only when numerous safety conditions have
been met. A fault must be corrected and the System reset before laser operation is
re-enabled. The monitoring system includes the following:
▪ Remote interlock that allows laser emission only when electrical continuity is
made across the contacts of the remote interlock connector located on the rear
of the console. The System is shipped with a remote interlock jumper already
connected, providing electrical continuity and allowing the laser to operate. To
set up a remote interlock switch, such as on the treatment room door, please
contact qualified personnel.
▪ The DiolazeXL and Vasculaze hand triggers allow laser emission only when the
Footswitch is pressed.
▪ Laser Energy monitoring to verify that the laser output is within specific energy
tolerances for every laser pulse. If abnormally low or high laser current
(indicative of optical energy) is detected, a System fault is triggered and the user
is notified.
To Next Page
Loading...
