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Norlase Leaf - Emergency Stop; Protective Housing; Safety Interlocks; Safety Shutter

Norlase Leaf
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Leaf User Manual
P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 64 of 85
Emergency Stop
When pressed, immediately turns off power to the laser.
Protective Housing
The system console has a protective housing that prevents unintended human
access to laser radiation above Class I limits. This housing is to be opened only by
certified personnel.
Safety Interlocks
The protective housing is not designed to be removed by the user during operation or
maintenance. Therefore, the system does not have and is not required to have any
safety interlock within the meaning of US FDA 21 CFR, Section 1040 or European EN
60825-1.
Safety Shutter
The laser system utilizes an electronic laser safety shutter. The system will not be
able to emit laser light unless all safety conditions are met prior to depressing the
footswitch. The safety shutter is activated when the system is off, during the self-test
at turn-on, in STANDBY mode or when the safety monitor detects a fault.
Location of Controls
Controls are located on the touch screen control panel.
Manual Reset
If laser emission is externally interrupted during treatment by activation of the door
interlock, the system will automatically go into STANDBY and the safety shutter will
revert to a closed position. To resume treatment, reset the system by placing the laser
in READY.
If laser emission is interrupted by main electrical power loss, the system will
automatically turn off. To resume treatment after an electrical power loss, the system
must first be manually restarted by rotating the key switch to the ON position.
Electrical Fault Detection Circuitry
If the electronic system detects a fault condition, laser exposure cannot occur. The laser
is disabled, the safety shutter is closed and the footswitch is disabled. Some fault
conditions may be cleared by the operator. See “Troubleshooting” for additional
information.
Location of Regulatory and Other System Labels
As required by the regulatory bodies, appropriate warning labels have been mounted
in specified locations on the instrument to indicate conditions under which the user
could be subjected to laser radiation. Location and description of caution, warning and
system labels are described on the following pages.

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