Regulatory Compliance 15
Selecta
PBL200051, Rev J
Regulatory Compliance
Lumenis lasers and delivery systems comply with 21 CFR Chapter 1,
Subchapter J, as administered by the Center for Devices and Radiological
Health of the US Food and Drug Administration (FDA).
CE-labeled devices comply with all appropriate performance standards as
specified in Annex II of the Medical Device Directive MDD 93/42/EEC.
Key lock switch
To prevent unauthorized use, the laser can only be turned on with the master
key, the key can only be removed when the laser is turned off, and the laser
only operates when the key is inserted into the keyswitch. When the keyswitch
is turned to the start position, the laser power-up sequence is initiated.
Emergency off pushbutton
The laser has an emergency off pushbutton which immediately turns off the
laser.
Laser emission indicator
Illumination of the laser emission indicator on the remote control provides a
visible warning to the operator that after approximately 2 seconds laser
radiation is accessible. The time delay is incorporated to allow appropriate
action by the operator to avoid unintentional laser radiation exposure.
External door interlock
An external door interlock receptacle and plug are provided to disable the laser
if the treatment room doors are opened. Refer to the Laser Safety Eyewear
section of this manual for additional information.
Manual reset
If laser emission is externally interrupted during treatment by remote
interlock activation, the laser will automatically go into standby and the safety
shutter will revert to a closed position. To resume treatment, manually reset
the laser by placing the laser in ready mode. If laser emission is interrupted
during treatment by main electrical power loss, the laser system will
automatically turn off. To resume treatment after an electrical power loss, the
system must be manually restarted by rotating the keyswitch to the start
position.The laser will automatically go into standby when electrical power is
resumed. To resume treatment, manually reset the laser by placing the laser in
ready mode.
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