Directions for Use
Introduction
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absorption of light into tissue and the conversion of that light energy to heat. Different
tissues absorb and reflect different wavelengths of light. The combination of reflected
wavelengths is what we perceive as color. If specific wavelengths of light are not
reflected, they are absorbed, and that absorbed light energy is converted to heat.
Regardless of the brand or type of light used, light energy in excess of that required for
good visualization will contribute to tissue warming and therefore should be avoided.
Risk of Fire
There is serious risk of igniting fires if the energized fiberoptic cables are placed on
flammable materials. Never disconnect a terminal device from an energized fiberoptic
cable or place an energized terminal device on any flammable material.
Risk of Tissue Injury
High intensity light can cause burns to tissue even if the tip of the fiberoptic cable or
attached terminal device is cool. Burns are caused by the absorption of light by tissue and
the subsequent conversion of that light energy into thermal energy (heat). Full-thickness
burns can be caused by prolonged exposure to concentrated light energy. Anesthetized
patients and poorly perfused tissues are particularly susceptible to burn injuries via this
mechanism.
Risk of Fiber Damage
The ProXenon 350 Surgical Illuminator produces very high levels of visible light and is
optimized to power the Welch Allyn ProXenon Surgical Headlight. When using endoscopic
or surgical headlight fibers without canes, lenses or fusing at the input end, irreparable
fiber damage may result when the ProXenon Surgical Illuminator intensity level is set
above 70% and total accumulated lamp hours are 100 hours or less.
The ProXenon headlight fiber uses fusing technology at the input end to eliminate the use
of epoxy as is common in the traditional fiber manufacturing process. It is primarily this
epoxy that burns and causes fiber damage when exposed to high intensity light energy.
Welch Allyn has tested different brands and types of fiberoptic cables for durability in the
ProXenon 350 Surgical Illuminator. Damage was found to most fibers with exposed epoxy
ends when the ProXenon 350 Surgical Illuminator intensity is set above 70% and the
lamp has less than 100 hours of accumulated use. Fiberoptic cables that use fusing
techniques, a cane, or a lens on the input end of the cable, show better tolerance to the
intense visible light energy of the ProXenon 350 Surgical Illuminator. However, because
Welch Allyn cannot control other manufacturer's materials or manufacturing processes,
any brand or type of fiberoptic cable previously tested and shown to withstand the light
energy of the ProXenon 350 Surgical Illuminator could fail if the manufacturer implements
a change in process or material of said fiber. Therefore, Welch Allyn cannot attest to the
survivability of any fiberoptic cable used in the ProXenon 350 Surgical Illuminator other
than the 902 series ProXenon Headlight Fiber.
