LIT-255
CUDA
®
SURGICAL
Rev. D
Page 3 of 128
(English)
1.
INTRODUCTION
The CUDA
®
Surgical 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 surgical procedures on an external monitor. 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 console which displays these captures onto an external monitor.