Introduction; Indications For Use; Functions Of Design - Sunoptic Surgical Titan X450 Manual De Operación

1.

INTRODUCTION

Congratulations on the purchase of your new Titan x450 Xenon Illuminator!
This user-friendly Xenon Illuminator is a high efficiency light source utilizing state-of-the-art
illumination technology. It offers a variety of features such as:
•
5600 K color temperature provides daylight brightness for perfect color definition
•
Quiet operation
•
Compact and light weight
•
Turret which adapts to various types of light guides
•
Mechanical Iris
•
Easy lamp replacement
•
Touchscreen Interface
This operator Instructions for Use manual will help you to install the device and optimally integrate it with
other components of your system. It will instruct you on how to operate the Xenon Illuminator 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 intended use of this device is to provide light for fiberoptic cables and instruments – providing
light for instrumentation via fiberoptic cables for use in surgical fields.
The xenon illuminator is intended to be used in a controlled operating room environment by
qualified medical personnel. The 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 xenon illuminator comprises a standalone, mains-powered illuminator that produces 390klux
(minimum) with a standard headlight at 16-inch (40cm) distance 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 touchscreen interface located on the front panel of the
console.
LIT-219 Sunoptic Surgical
Rev. F
®
Page 3 of 147
(English)