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8/2021
Product Description / Intended Use
This product from FSN Medical Technologies is a high-end surgical display monitor designed for
advanced digital OR applications. This medical display is uniquely equipped to handle tasks in
the demanding operating room environment. Performance characteristics include:
• Rapid signal detection, robust mode tables
• Artifact-free images
• Calibrated to clinical color
• Zoom, freeze, picture-in-picture
Intended Purpose
This device is intended to be connected to other medical equipment, and to display images or
videos from endoscopic cameras, room cameras, and patient information such as ultrasound,
cardiology, and anesthesiology. This device is not intended for diagnosis. This device is intended
to be compatible with other highly specialized surgical and diagnostic equipment used in surgi-
cal suites, operating rooms, emergency rooms, and procedural facilities.
Intended Use Environment
This device is intended to be used by a trained medical professional in a healthcare facility set-
ting where contact with a patient is unlikely (no applied part).
This device is designed to meet the medical safety requirements for a patient vicinity device.
Warning: This device may not be used in connection with life support equipment.
Indications for Use
This device is to be used by a trained medical professional to display images from procedures,
such as endoscopy, ultrasound, cardiology, and anesthesiology. This device connects to medical
imaging equipment to display images, videos or patient information during surgical procedures.
This device is not intended for diagnosis.
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