LIT-237
CUDA
®
Surgical
Rev. E
(English)
Page 3 of 73
1. INTENDED USE
Thank you for your purchase of your new LED-5500 Headlight!
This LED-5500 Headlight system is designed to deliver illumination from a high intensity
LED for surgical site illumination. The LED-5500 is a battery powered, portable headlight
with an adjustable spot and infinitely dimmable LED.
The LED-5500 also includes a built-in battery gauge located on the control module on one
side of the headband. The battery life will increase when decreasing the intensity of the
light output. The battery gauge is a convenience and the user should have a plan for backup
lighting for any application for using this system; see GENERAL WARNINGS.
2.
GENERAL WARNINGS
2.1
Headlight Warnings
•
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 attempts to use this
product clinically.
•
Before each procedure, carefully check the battery state of charge to assure optimal
duration for this procedure, and have a backup charged battery accessible.
•
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
CUDA
®
Surgical
.
To order additional batteries, please call customer service 1-877-814-2237 (+1-904-208-
2290 International)
•
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 is suitable for operation in ambient environments from 0 to 30
⁰
C.
•
The headlight meets CISPR 11 Class B limits and is suitable for use in a hospital and
residential environment, but not in proximity to RF emitting equipment.
•
Any serious incident that has occurred in relation to the device should be reported to the
manufacturer and the competent authority of the Member State in which the user and/or patient
is established.
