4
FIRE HAZARD: DO NOT DRAPE OR COVER THE LIGHT SOURCE
OR THE LIGHT GUIDE WHILE IT IS OPERATING. DO NOT
PLACE THE LIGHT GUIDE ON A DRAPE WHILE
IT IS OPERATING.
CAUTION: The metal portions of the cable at the light source
get hot during operation. Allow components to cool outside of
the light source for at least 5 minutes before touching.
• The user of this product should be thoroughly familiar
and trained in the use and care of this product.
• The user should carefully study this manual before
making any attempt to use the product clinically.
Instructions should be followed specifically, with
special attention given to warnings and cleaning
instructions. This manual should also be available to
the surgical team during a procedure.
• Follow the instructions in the operating manuals of
other manufacturer’s equipment when they are use in
conjunction with this product.
• Before every procedure, carefully inspect the light
guide cable to ensure it has been properly maintained,
cleaned and sterilized (if compatible), and that it is
fully functional.
• Any light source used with this cable should have a
maximum output of 0.25W IR at the cable port to
prevent cable and/or headlight damage during use.
• Light sources use high intensity lamps, which
produce heat as well as brilliant light. The high
brightness produced by the light source and the light
output of the light guide cable can cause burns when
used within 10 inches.
• Care should be taken to follow the maintenance and
cleaning instructions. Excessive bending of the cable
should be avoided.
• Use care not to point the light guide directly at the
eye while in operation. The brilliant light output can
cause severe eye discomfort.
• 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.
• It is the users responsiblity to study the information provided
in the operations and users manual with respect to set-up,
General Warnings
use and care of this device. Instructions should be followed
with special attention given to warnings, controls and
specifications. Follow the manufacturer’s instructions for
other devices not recommended by this manual when used
in conjuction with the headlight system.
• Before using, carefully inspect the device to ensure it has
been properly maintained and cleaned and that it is fully
functional. DO NOT use if inspection reveals any damage
such as case damage or loose connectors.
• It is the user’s responsibility to check the specifications
of any light sources attached to this headlight System to
verify that it can transmit the intense light output without
generating high temperatures and heat build-up in the
headlight system that can cause serious burns. Integra
light sources are recommended for use with the headlight
systems are listed in this manual.
• Ensure that the fiber optic light guide matches the port
type of the light source, to prevent damaging the optical
components of the light sources and to prevent the
overheating of the fiber optic light guide connectors.
The high intensity light at the connecting ends of the fiber
optic light guides may become hot
• When the light source is used to power a headlight system,
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.
• Take precautions not to place and rest a hot cable, metal
end fitting, or headlight on a patient, patient drape,
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.
• 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.
• Do not use this device for Ocular Surgery or in a procedure
that 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.
