Introduction; Indications For Use; Function Of Design - Sunoptic Surgical HDC-300 Manual De Instrucciones

1. INTRODUCTION

The Sunoptic Technologies High Definition Camera System is a head-mounted surgical
camera used to capture still and video images of surgical procedures.
You have chosen the best and we would like to make sure you receive optimal results with
your new Camera System by using it correctly.
This Operator Manual will help you to install, operate and clean the Camera System. It will
give you maintenance and service guidelines as well as recommendations for best
performance results.
Federal law (United States of America) restricts this device to use by, or on the order of, a
physician.

1.1. INDICATIONS FOR USE

The intended use of this device is to display, record and play back surgical procedures.
The HD Camera 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, and is not to be used with or as an endoscope or related
system. This device has no essential performance as defined in IEC 60601-1. Should this
device fail to operate, a suitable backup should be available for any procedure in which
this device may be used.
There are no known contraindications.
The HD Camera is intended to be used in a controlled operating room environment with
compatible devices by qualified medical personnel. The camera system and head are
provided non-sterile.

1.2. FUNCTION OF DESIGN

The HD Camera System comprises a camera head that couples to a light source which
captures video and/or still images and console which displays these captures onto an
external monitor. Displayed images and videos may be captured and stored internally or
transferred or transmitted via a variety of means, controlled through the device's integrated
touch panel.
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