Introduction; Indications For Use; Functions Of Design - Sunoptic Surgical LED-4500 Manual Del Usuario

1. INTRODUCTION

The LED-4500 is the next generation of user-friendly, high efficiency LED illuminators. It offers
a variety of features such as:
• Whisper quiet operation
Compact and light weight
•
Pulse-width modulation (PWM) LED brightness dimming for color quality
•
Ergonomic turret which accepts various light guides including ACMI, WOLF,
•
OLYMPUS, and STORZ
Auto shutter activates when light guide is removed
•

1.1. Indications for Use

The intended use for the LED-4500 is to provide general illumination to a surgical site
including but not limited to arthroscopy (orthopedic surgery), laparoscopy (general and
gynecological surgery), and endoscopy (general gastroenterological and ENT surgery).
The device is not intended to diagnose, prevent, monitor, treat or alleviate disease,
injuries, or handicaps, nor for the investigation, replacement, or modification of the
anatomy or of a physiological process.
There are no known contraindications.
The LED-4500 is intended to be used in a controlled operating room environment with
compatible devices by qualified medical personnel. The LED-4500 is provided non-sterile.

1.2. Functions of Design

The LED-4500 comprises a standalone, mains-powered illuminator. The illuminator is
typically used with a fiberoptic light guide. Light intensity is controlled via button interface
located on the front panel of the console. Additionally, the device can enter a non-
illuminated STANDBY mode by pressing the STANDBY button also located on the front
panel. Additionally, main LED illumination can be turned OFF by removing the light guide
from the active port while the illuminator is ON.
LIT-258 Sunoptic Surgical
Rev. A
®
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(English)