Cuda surgical Elite 1000 Mode D'emploi page 3

1. INTRODUCTION
Congratulations on the purchase of your new Elite 1000 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 daylight brightness for perfect color definition
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Quiet operation
•
Compact and light weight
•
Turret which adapts to various types of light guides
•
Mechanical Iris
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Easy lamp replacement
•
Lamp life display indication
In short, you have chosen the best and we would like to make sure you receive the optimal results
with your new illuminator 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 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 235klux
(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
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LIT-217 CUDA Surgical
Rev.F
Page 3 of 98
(English)