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Iridex PASCAL Synthesis - Titration; Fire Hazard

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PASCAL
®
Synthesis Ophthalmic Scanning Laser Systems Page 20 of 141
88292-EN, Rev D
Please note that when retrieving a favorite that has been saved in titration mode, the values
of the pattern parameters that are not allowed to be changed in titration will be restored to
the defaults.
Titration
WARNING
A single titration session at the very beginning of a treatment may be insufficient, as different
areas of tissue may respond differently over the course of the treatment. Uniform tissue
response should be continuously assessed by the end-user and re-titration may be
necessary during the procedure.
Please confirm that Endpoint MGMT is automatically disabled and grayed out during titration
mode .
Attempting to perform titration when EndPoint Management is turned on may result in
overpower exposure.
Fire Hazard
WARNING
Do not use the laser system in the presence of flammables or explosives such as volatile
anesthetics, alcohol, certain surgical preparation solutions or other such substances. An
explosion and/or fire could occur.
Do not use in an oxygen-rich environment.
The treatment beam can ignite most nonmetallic materials. Use fire retardant drapes and
gowns. The area around the treatment site can be protected with towels or gauze sponges
moistened with sterile saline solution or sterile water. If allowed to dry, protective towels and
sponges can increase the potential fire hazard. A UL-approved fire extinguisher should be
readily available.
Per IEC 60601-2-22: The use of flammable anesthetics or oxidizing gases such as nitrous
oxide (N2O) and oxygen should be avoided. Some materials (e.g., cotton wool) when
saturated with oxygen may be ignited by the high temperatures produced in normal use of
the system. The solvents of adhesives and flammable solutions used for cleaning and
disinfecting should be allowed to evaporate before the laser system is used. Attention
should also be drawn to the danger of ignition of endogenous gases.

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