26
70375-EN Rev B
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 the Slit Lamp Adapter, LIO, EasyFit Adapter, Iridex Integrated Slit Lamp
Workstation, SL130 Integrated Slit Lamp Workstation, and TxCell Scanning Slit Lamp Adapter. 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.
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.
Always wear laser safety eye wear when performing or observing laser treatments with the unaided eye.
Safety Compliance
Complies with FDA performance standards for laser products, except for deviations pursuant to Laser
Notice No. 50, dated June 24, 2007.
CE-labeled devices comply with all requirements of the European Medical Device Directive MDD 93/
42/EEC.
