Introduction; Intended Use/Indications For Use; Warnings/Labeling - Cuda surgical LIT102 Instrucciones De Utilizacion

1.

INTRODUCTION

The LED Rover is a Light Emitting Diode (LED) and battery unit to couple onto the light
post of commercially available endoscopes having an ACMI or Wolf light post. The LED
Rover is made to take the place of conventional light cable and remote light source. It
couples to the endoscope in the same fashion as a conventional light cable by press
fitting onto the endoscope's light post. The LED Rover is powered by two lithium 3V,
CR123 batteries (or interchangeable equivalents).
The batteries power an LED via a current converter that supplies a constant current to
the LED. The light is directed into the light post of the scope. The light is then carried
by fiber optics internal to the scope to illuminate the target.
2. INTENDED USE / INDICATIONS FOR USE
The LED Rover is used to illuminate the site of surgery during minimally invasive
surgical procedures in arthroscopy (orthopedic surgery), laparoscopy (general and
gynecological surgery) and in Endoscopy (general, gastroenterological and ENT
surgery). The light is transmitted from the light source through a scope.
3. WARNINGS / LABELING
3.1 WARNINGS
Caution
flammable anesthetics.
Caution Federal law restricts this device to sale by or on the order of a licensed
practioner.
Caution The LED Rover is provided non-sterile. If used for sterile procedures, the unit
must be sterilized or draped with commercially available surgical drapes.
LIT102 CUDA Surgical
®
(English)
Battery powered equipment is considered unsuitable for use in the presence of
Rev. O
Date of Revision:07/22/14
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