LIT-212 CUDA
®
Rev. A
(English) Date of Revision:07/20/16
Page 3 of 53
1. INTENDED USE
This LED ELITE 9000 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 ELITE 9000 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 batteries state of charge (Fuel
Gauge) to assure optimal duration for the procedure.
LED High Intensity Light sources using high intensity LEDs that will produce
some heat as well as light. The high output of such LEDs can cause the
headlamp to feel warm to the touch during operation, this is normal.
The battery charger and the battery chargers power supply are not to be used
in the operating room theater or the patient area.
Use care not to point the light directly at the eyes during operation, the brilliant
light can cause severe eye discomfort.
Users are responsible for providing backup lighting systems for your application
when using this device.
