Introduction; Indications For Use; Function Of Design - Sunoptic Surgical HDC-300C Mode D'emploi

1.

INTRODUCTION

Congratulations on the purchase of your new HD Camera System!
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
physician.

1.1. INDICATIONS FOR USE

The intended use of this device is to display, record and play back surgical procedures. As such, this device
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. As such, this device has no essential performance in
accordance with IEC 60601 and users are advised that should this system fail to operate, suitable backup
systems 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 incorporates a remote camera head which captures an image as presented with a
coupled light source and displays this image onto a viewing 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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