Iridex IQ 577 - Safety Compliance

34 IRIDEX IQ 577
®
/IQ 532
®
Laser Systems Operator Manual 15510-EN Rev G
Safety Compliance
ComplieswithFDAperformancestandardsforlaserproductsexceptfordeviationspursuanttoLaser
NoticeNo.50,datedJune24,2007.
CE-marked devices comply with all requirements of the European Medical Device Directive
MDD93/42/EEC.
Feature Function
EmErgEncy Stop
Immediately disables the laser.
Protective housing The external housing prevents unintended access to laser radiation above
Class I limits.
Safety interlock An electronic interlock at the ber port prevents laser emission if a delivery device is
not properly connected.
Remote interlock An external door interlock outlet is provided to disable the laser if the treatment
room doors are opened during treatment. An interlock jumper wire is also provided.
Keyswitch The system operates only with the proper key. The key cannot be removed while in
the On position.
Laser emission indicator The yellow Standby light provides a visible warning that laser radiation is accessible.
When Treat mode is selected, a three-second delay prevents unintentional laser
exposure. The console delivers laser energy only when the footswitch is depressed
while in Treat mode. An audible tone indicates that the console is delivering laser
energy. The audible indicator volume can be adjusted but not turned off.
Beam attenuator An electronic beam attenuator prevents any laser radiation from exiting the console
until all requirements for emission are met.
Viewing optics Eye safety lters are required when using the laser system.
Manual restart If laser emission is interrupted, the system goes into Standby mode, the power
drops to zero, and the console must be manually restarted.
Internal power monitor Two monitors independently measure the laser power before emission. If the
measurements differ signicantly, the system enters Call Service mode.
Footswitch The laser cannot be placed in Treat mode if the footswitch is damaged or improperly
connected. The footswitch can be immersed and cleaned (IPX8 per IEC60529) and
is shrouded for safety (ANSI Standard Z136.3, 4.3.1).