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The LumenEye® X1 device is intended to be used to examine the rectum, and using additional accessories, perform tissue sampling of the rectum, if required. The LumenEye® X1 can enable suitably trained healthcare professionals in clinical environments, when used in conjunction with other tests, to examine the rectum as part of a clinical assessment in adults. The LumenEye® X1 is not intended to determine a final clinical diagnosis without further confirmatory tests. Following examination, the healthcare practitioner may make recommendations for further investigations as appropriate.

The LumenEye" X1 is a re-usable handheld rigid endoscope that permits insufflation of the rectum and endoluminal high-definition video capture to enable an examination of the rectum (Figure 1). The device has no lumens or channels within the reusable elements of the handle. The area of interest is illuminated by a distally mounted ring of LEDs which emit white light (5300K). Light reflected from the subject is captured by the HD CMOS sensor. The LEDs and camera sensor are housed in the distal end of a stainless-steel camera tube. The image is transferred via USB protocol to a PC and displayed on a screen. There is limited firmware capability within the sensor which simply enables the LEDs to turn on when a video feed from the camera is requested by the PC. The device functions with any Off-the-shelf (OTS) software with a camera display capability. The full HD CMOS camera provides 1080p, 90° field of view and a frame rate of 60 frames per second. The camera enclosure is IP67 rated. The device features a 1.8m long PVC cable and is powered via USB 3.0 Type-A connection (maximum input voltage 5V, rated current 500mA).