®
LIT-235
SUNOPTIC SURGICAL
(English)
Rev. A
Date of Revision: 06/19/18
Page 3 of 3
1. INTENDED USE
This LED TITAN 9500 Headlight system is designed to deliver illumination from a high
intensity LED for surgical site illumination.
Congratulations on the purchase of your new LED Headlight system.
The LED Headlight TITAN 9500 is a battery powered portable headlight with an
adjustable spot and uses encrypted battery technology that requires the use of
approved batteries obtained from the manufacturer or authorized distributors.
Additionally, a low battery alarm is offered in this system and will beep when power is
low. Decreasing the output may extend battery life and therefore the amount of warning
time before power down. This alarm is a convenience and the user should plan for
backup lighting for any application using this system; see General Warnings.
2. GENERAL WARNINGS
Note: You must charge the batteries fully before using the headlight for the first
time.
•
The user of this product should be thoroughly familiar with the use and care of this
product.
•
The user should carefully study the manual before making any attempt to use this
product clinically.
•
Before each procedure, carefully check the battery state of charge to assure optimal
duration for this procedure.
•
LED high intensity headlights will produce some heat in addition to light. The high
output of these headlights may become warm to the touch. This is normal operation.
•
Light source can cause damage to the eye if viewed directly with unprotected eye.
•
User is responsible for determining if interruption of light output will create an
unacceptable risk. If this determination is made, arrangements (such as standby
illuminator) should be made to reduce risk.
•
Users are responsible for providing backup lighting systems for your application when
using this device.
•
The illuminator produces a highly concentrated (luminous energy per unit area) light
beam. Qualified personnel must determine a safe working distance and intensity setting
for each application.
•
Not suitable for use in presence of flammable anesthetic mixture with air or with oxygen
or nitrous oxide.
•
To prevent fire or electric shock, do not open or expose the illuminator unit to rain or
moisture. Refer all servicing to qualified personnel only.
•
The headlight should only be used with approved batteries supplied by Sunoptic
Technologies. To order additional batteries, please call customer service 1-877-677-
2832
•
User should ensure that the air vents located on the headlight module are not
obstructed or blocked to allow the headlight to receive the necessary cooling to prevent
an over temperature shut off.
•
The headlight meets CISPR 11 Class A limits and is suitable for use in a hospital
environment, but not in proximity to RF emitting equipment. The headlight may interfere
