LIT-220 CUDA
®
Rev. A
(English) Date of Revision:09/01/17
Page 3 of 51
1. INTENDED USE
This LED ELITE 8500B 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 8500B is a battery powered portable headlight with an adjustable
spot.
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 is dependent upon usage and battery conditions. 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.
