Indication For Use; Warnings / Cautions - Sunoptic Surgical LIT-051 Manuel D'utilisation Et D'entretien

1. INDICATION FOR USE

Congratulations on the purchase of your new Headlamp system.
This fiber optic headlamp system is designed to deliver illumination from a high intensity
light source for surgical site illumination.
This Operator Manual will help you to install the device and optimally integrate it with other
components of your system. It will also instruct you how to make adjustments, how to
keep it clean, and sterilize it. It will give you maintenance and service guidelines as well as
recommendations for best performance results.

2. WARNINGS / CAUTIONS

CAUTION
WARNING The user of this product should be thoroughly familiar with the use and
care of this product.
WARNING The user should carefully study this manual before making any attempt to
use this product clinically.
WARNING Use of this illuminator with accessories or attachments requires that the
end-user follow all accessory or attachment instructions which could affect illuminator
setup, usage and/or settings.
CAUTION: HOT SURFACE The module may become warm during use; if
uncomfortably warm, open the iris and adjust illuminator output.
WARNING Light sources using high intensity lamps will produce heat as well as light.
The high output of such systems can cause burns. Use care to avoid pointing the light
directly at anyone's eyes during operation as the brilliant light can cause severe eye
discomfort.
WARNING The metal end fittings of the fiber optic cable get hot during
operation. Allow to cool outside the light source for at least five minutes before
touching.
WARNING
FIRE or INJURY HAZARD:
optic light guides is retained in the cable and transmitted through a connected instrument or
the cable end tip. The output of a connected headlight module or instrument, or a bare end
tip left in close proximity or contact with tissue or flammable materials presents a risk of
injury or fire. Qualified personnel must determine a safe working distance and intensity
setting for each application. The output should never be left on unattended.
The headlight should never be brought closer than 12" to the patient without decreasing the
light source output.
LIT-051 Sunoptic Surgical
Rev. H
Rx only. Federal law restricts this device to sale by or on the order of
a licensed healthcare practitioner.
®
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Energy released by illuminators used with fiber
(English)