LIT-239
SUNOPTIC SURGICAL
®
Rev. A
(English)
Page 3 of 21
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 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. 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 is provided
non-sterile. The system has a 3 year expected service life.
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.
