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Zsquare ENT-Flex endoscope is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic endoscope procedures.

Zsquare ENT-Flex endoscope is a flexible, high-resolution endoscope with a narrow insertion diameter composed of a Single-Use Shell, provided sterile, that fully encompasses a reusable Imaging Core. The Zsquare ENT-Flex endoscope is intended to visualize the internal cavities of the ear, airways, nose, and sinus cavities during diagnostic endoscope procedures. The endoscope is to be used with a Console provided by Zsquare in a hospital or clinic environment. This device is designed to reduce the need for high-level disinfection and/or sterilization between patients by providing a sterile disposable Single-Use Shell that is used in combination with a reusable Imaging Core. The Zsquare ENT-Flex system consists of a/an: • Endoscope comprised of a: • Disposable Single-Use Shell that is comprised of the handle, the steering mechanism, and the steerable shaft (imaging fiber, illumination fiber and distal optics). It is the only part that contacts the patient and physician's soiled hands and is disposed of at the end of the procedure. • Reusable Imaging Core, which is a hand-held multi-use unit containing the optical system that is composed of a lens array and a camera. At the end of a procedure, the Imaging Core is disengaged from the Shell and cleaned with ethanol wipes. - · Console comprised of a/an: - o Illumination Unit - o Camera Control Unit (CCU) - o Monitor/Screen - Keyboard with touchpad - o Footswitch - o Cart The console enables the image-processing. A data cable connects to the endoscope and transfers the video data to the image-processing unit. The image is transferred and displayed on a graphical user interface (i.e.: monitor). Power is supplied to the camera contained in the Imaging Core by a cable from the CCU. A second cable is connected to the illumination source to control the illumination.