4
• FIRE HAZARD: DO NOT DRAPE OR COVER THE LIGHT
SOURCE WHILE IT IS OPERATING. DO NOT PLACE THE
FIBER OPTIC CABLE OR HEADLIGHT ON A DRAPE WHILE
THE LIGHT SOURCE IS OPERATING.
• ONLY USE INTEGRA ULTRALITE PRO CABLES WHEN
USING THIS HEADLIGHT
• Do not place or rest a hot cable/metal end fitting or
headlight on a patient or come into contact with
unprotected skin until all components are cooled for at
least 5 minutes. Failure to do so can result in burns
and/or tissue damage.
• Light sources use high intensity lamps which produce heat
as well as brilliant light. The heat produced by the light
source and the light output of the fiber optic cable can
cause burns. It is recommended that a standard 16”
working distance separating the headlight and the
patient is maintained.
• Under no circumstances should the headlight be placed
closer than 10” to any tissue or object. A risk of injury to
tissue due to exposure to intense illumination may occur.
The risk of injury is reduced by using the minimum level of
illumination necessary, by minimizing exposure time, and by
avoiding close stationary viewing. Thermal burns of tissue
can occur with improper use of the device.
• Follow the instructions in the operating manuals of other
manufacturer’s equipment when they are used in
conjunction with this product.
• Before every procedure, carefully inspect the fiber optic
cable to ensure it has been properly maintained and cleaned
and that it is fully functional. Ensure the headlight module
has no loose parts and is properly attached to the headband.
• Use the light source at the lowest possible attenuation to
prevent cable damage or excess heat.
• Care should be taken to follow the maintenance and
cleaning instructions.
General Warnings
A warning statement in this manual identifies a condition or practice which, if not corrected or discontinued immediately, could lead
to patient injury, illness, or death. The user should carefully study this manual before making any attempt to use the product in a
clinical environment. Instructions should be followed specifically, with special attention given to warnings and cleaning instructions.
This manual should also be available to the appropriate personnel during use.
• Excessive bending of the cable should be avoided.
• Use care not to point the headlight directly at the eye while
in operation. The brilliant light output can cause severe
eye discomfort.
• Do not use this device for Ocular Surgery or in a procedure
requiring direct illumination of the eye.
• Do not look directly at the headlight or open end of the
fiber optic cable. Permanent eye damage can occur.
• Do not immerse the headlight or cable in liquids.
Precautions
• Take precautions to verify that the fiber optic cable is
appropriately suited for the light source. Xenon and other
high illumination light sources require premium fiber optic
cables in order to achieve optimal performance and prevent
damage to the fibers, thereby diminishing the quality of the
light output or the useful life of fiber optic cable. Use only
fiber optic light guide cables with the correct proximal
fitting for your turret and approved and tested for
compatibility with high intensity Xenon lamps of
300W or higher.
• Take precautions not to touch or disconnect the cable end
fitting from the turret until the light source has been “shut
down” for a period of time and allowed to cool. The cable
end fitting will remain hot immediately following shut
down, which can cause burns.
• Take precautions to not place and rest a hot cable end
fitting and/or headlight on a patient or allow the system
to come in contact with un-protected hands or tissue.
The entire system should be allowed to cool following use.
Failure to do so can cause burns and/or tissue damage.
