Iridex IQ 577 - 6 Safety and Compliance; Protection for the Physician; Protection for All Treatment Room Personnel

32 IRIDEX IQ 577
®
/IQ 532
®
Laser Systems Operator Manual 15510-EN Rev G
6
Safety and Compliance
Toensuresafeoperationandpreventhazardsandunintendedexposuretothelaserbeams,readand
follow these instructions:
• Topreventexposuretolaserenergy,exceptasatherapeuticapplicationfromeitherdirector
diffusely reflected laser beams, always review and observe the safety precautions outlined in the
operator manuals before using the device.
• Thisdeviceisintendedforuseonlybyaqualifiedphysician.Theapplicabilityoftheequipment
and treatment techniques selected is your sole responsibility.
• Donotuseanydeviceifyouthinkitisnotfunctioningproperly.
• Laserbeamsreflectedfromspecularsurfacescanharmyoureyes,thepatient’seyes,orothers’
eyes. Any mirror or metal object that reflects the laser beam can constitute a reflection hazard.
Be sure to remove all reflection hazards near the laser. Use non-reflecting instruments whenever
possible. Be careful not to direct the laser beam at unintended objects.
CAUTION: Changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment.
Protection for the Physician
Eye safety filters protect the physician from backscattered treatment laser light. Integral eye safety
filters are permanently installed in every compatible Slit Lamp Adapter (SLA) and Laser Indirect
Ophthalmoscope (LIO). For endophotocoagulation or for Operating Microscope Adapter (OMA) use,
a separate discrete eye safety filter assembly must be installed into each viewing path of the operating
microscope. All eye safety filters have an optical density (OD) at the laser wavelength sufficient to
permit long-term viewing of diffuse laser light at Class I levels.
Always wear appropriate laser safety eye wear when performing or observing laser treatments with
the unaided eye.
Protection for All Treatment Room Personnel
TheLaserSafetyOfficershoulddeterminetheneedforsafetyeyewearbasedontheMaximum
PermissibleExposure(MPE),NominalOcularHazardArea(NOHA),andNominalOcularHazard
Distance(NOHD)foreachofthedeliverydevicesusedwiththelasersystem,aswellasthe
configurationofthetreatmentroom.Foradditionalinformation,refertoANSIZ136.1,ANSIZ136.3,
or European Standard IEC 60825-1.