Selecta
PBL200051, Rev J
16 Safety and Regulatory
Protective housing
The laser has a protective housing that prevents unintended human access to
laser radiation above Class I limits. The housing must only be opened by a
Lumenis-certified technician.
Safety interlocks
The protective housing is not designed to be removed by the user during
operation or maintenance. Therefore, the laser does not have, and is not
required to have, any safety interlocks within the meaning of US FDA 21
CFR, Section 1040 or International Standard IEC 60825-1. However, the
protective housing cannot be easily opened without special tools.
Location of controls
Operation and adjustment controls are located so that the user need not be
exposed to laser radiation during laser operation or adjustment.
Eye filter
The slit lamp has specially designed eye filters which guard the operator from
exposure to laser radiation. The protective filter ensures that all laser radiation
returned to the operator's eyes is below the Class I limit.
Safety shutter
The laser includes an electronic safety shutter that prevents unintentional laser
emission. The safety shutter opens only when the user places the system in
ready mode and depresses the footswitch or joystick laser activation
pushbutton. The safety shutter remains closed when the system is turned off,
during self-test at system turn on, when the system is placed in standby mode,
or when the safety monitor detects a fault.
Electronic fault detection circuitry
If the electronic system detects a fault condition, laser exposure cannot occur.
The high voltage power supply is turned off, the high voltage capacitor is
discharged, the safety shutter is closed, and the footswitch and joystick laser
activation pushbutton is disabled.
Some fault conditions may be cleared by the operator. Refer to the
Troubleshooting Guide in this manual for additional information.
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