PASCAL
®
Synthesis TwinStar Ophthalmic Scanning Laser Systems
Page 26 of 142
88293-EN, Rev C
Vibration or physical shock may affect the quality, performance and reliability of the
equipment.
Regulatory Compliance Safety Features
PASCAL Synthesis Ophthalmic Scanning Laser System 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
The 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
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 plug and connected to the system
interlock receptacle on the rear 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) or removing the plug disables the system and
the system returns to STANDBY mode with “<Door Interlock>” displayed on the control
panel.
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
