PASCAL
®
Synthesis TwinStar Ophthalmic Scanning Laser Systems
Page 27 of 142
88293-EN, Rev C
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.
Ophthalmic Applications
PASCAL Synthesis TwinStar Ophthalmic Scanning Laser System is used to treat ocular
diseases in both the posterior and anterior chambers of the eye. The laser systems are
well-suited for treating the eye, because they have minimal effect on transparent tissues
and materials. PASCAL Synthesis TwinStar laser energy can be efficiently delivered to
opaque structures of the eye through the transparent cornea, aqueous humor, lens and
vitreous humor, allowing many conditions to be treated by non-invasive techniques.
