Introduction; Indications For Use; Functions Of Design - Sunoptic Surgical LED-4000 Manuel De L'opérateur

1. INTRODUCTION

Congratulations on the purchase of your new LED-4000 Light Source!
This user-friendly, high efficiency LED light source utilizes state-of-the-art illumination technology. It
offers a variety of features such as:
•
Quiet operation
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Long life, 30,000 hrs.
•
Compact and light weight
•
Turret which adapts to various types of light guides
•
Pulse-width Modulation (PWM) Electrical Dimming
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Sensor automatically shuts off LED when light guide is removed
•
Standard CRI option provides 75 CRI and 6500K color temperature (nominal)
•
High CRI option provices 92 CRI and 5600K color temperature (nominal)
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-4000 comprises a standalone, mains-powered illuminator. The standard CRI model
produces 2200lm (typical) in the visible spectrum range, and the high CRI model produces 1200lm
(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-216 Sunoptic Surgical
Rev. E
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