Leaf User Manual
P/N: 97-4000, Revision 08, Release date: 2020-11-10 Page 63 of 85
Regulatory Compliance Safety Features
Norlase Leaf complies with 21 CFR subchapter J as administrated by the Center for
Devices and Radiological Health of the Food and Drug Administration (FDA). The
following FDA compliance safety features are included:
Key Lock Switch
The system can be activated only with the proper key to operate the master key
switch. The key cannot be removed in the ON position and the system will operate
only with the key in place. When treatments are complete, always remove and
secure the key to prevent unauthorized use of the system.
Laser Emission Indicator
A laser emission indicator is displayed to warn the user that the system is capable of
emitting laser energy and that appropriate precautions should be taken, such as using
the appropriate eyewear when in the treatment room.
Door Interlock / External Emission Indicator
A door interlock may be used in conjunction with a remote switch to disable the system
in case of certain external events (e.g., the opening of a treatment room door). A
remote switch or interlock can be wired to the door interlock connection and connected
to pins 1 & 2 on the interlock receptacle on the bottom of the system console. If a
remote switch is used, the system can be set in the READY mode only when the
remote switch is closed. Breaking the connection by opening the switch (door) disables
the system and the system returns to STANDBY mode with “<Door Interlock>”
displayed on the control panel. The switch must have a maximum of 40 ohms and
>1500 V isolation.
An external emission indicator may be triggered by connecting to pins 3 & 4. A
maximum of 24 V 100mA isolated supply may be used
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