Introduction; Indications For Use; Functions Of Design - Sunoptic Surgical LED-4500 Mode D'emploi

1. INTRODUCTION

Congratulations on the purchase of your new LED-4500 Light Source!
This user-friendly LED light source is a high efficiency light source utilizing state-of-the-art superior
illumination technology. 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
In short, you have chosen the best and we would like to make sure you receive the optimal results
with your new LED light source by using it correctly.
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 operate the LED light source and how to keep it clean.
It will give you maintenance and service guidelines as well as recommendations for best performance
results.

1.1 Indications for Use

The LED illuminator is used to illuminate the site of surgery during minimally invasive procedures
including, but not limited to arthroscopy (orthopedic surgery), laparoscopy (general and
gynecological surgery), and endoscopy (general, gastroenterological, and ENT surgery). Light is
typically transmitted from the illuminator through a fiber optic cable and typically a scope or other
light guide.
The LED illuminator is intended to be used in a controlled operating room environment by qualified
medical personnel. The LED illuminator is provided non-sterile and is not intended to be sterilized.
The system has an expected, but not limited, three-year service life.
The illuminator is not intended to be used for monitoring, diagnostic, or other life support functions.
This device does not sustain nor support life. The device is not intended to compensate for injury,
handicap, replacement or modification of anatomy, or control of conception. No special intervention
is necessary in the event of device failure. As such, this device has no essential performance as
defined by IEC 60601-1, and should this device fail to operate, a suitable backup should be
available for any procedure where it may be used.
There are no contraindications.

1.2 Functions of Design

The LED-4500 comprises a standalone, mains-powered illuminator. The standard CRI model
produces 2800lm (typical) in the visible spectrum range. The illuminator is typically used with a
fiberoptic light guide that connects to a light port located on the front panel. Light intensity is
controlled via pushbuttons located on the front panel of the console.
LIT-258 Sunoptic Surgical
Rev. B
®
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(English)