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Broncoflex® Agile and Broncoflex® Vortex This video-bronchoscope is intended to provide an optical display of the pulmonary tract using a monitor (Screeni®) and to be used with endotherapy accessories and instruments. This video-bronchoscope is designed for use exclusively in a hospital environment. Endotherapy accessories and instruments The effective length of an endoscopic instrument should be at least 30 cm greater than the effective length of the endoscope. | Model | Minimum compatible<br>endotracheal tube size | Minimum compatible dual<br>lumen endo-bronchial tube size | Maximum size of<br>endotherapy instruments | |-------------------|----------------------------------------------|-----------------------------------------------------------|--------------------------------------------| | Broncoflex Agile | $\ge 5.0$ mm | $\ge 35$ Fr. | $\le 1.2$ mm | | Broncoflex Vortex | $\ge 6.0$ mm | $\ge 41$ Fr. | $\le 2.6$ mm | Patient Population The Broncoflex can only be used on adult patients. Screeni® This device is designed for use exclusively in a hospital environment, in combination with an Axess Vision Broncoflex® video-bronchoscope.

Broncoflex Agile and Broncoflex Vortex are a single-use video-bronchoscope which is part of a system made up of the endoscope (Broncoflex) and its reusable display monitor (Screeni). The videobronchoscope is intended to provide an optical display of the pulmonary tract using a monitor (Screeni) and to be used with endotherapy accessories and instruments. The applied part of the medical device is the whole of the flexible tubing containing the insertion tube, the articulated section and the distal tip (BF type applied part: BF). Broncoflex is sterile and supplied ready to use in its sealed packaging (sterilization method ethylene oxide). The Screeni is a reusable nonsterile medical device and is a video processor with integrated touch interface designed to display live imaging data captured by Broncoflex Agile and Broncoflex Vortex. The consumables (Broncoflex) are supplied in sets of 5 in a carton. Inside this box, each sterilized consumable is placed in a single sterile pouch. Screeni is supplied in a carton with all the accessories (quick mounting bracket, knurled screw, power supply, EU/US/UK/AU adaptors and video cable (HDMI/DVI)). Broncoflex Agile and Broncoflex Vortex are the same devices except for some dimensional aspects such as external diameter of insertion tube, distal tip outer diameter and working channel inner diameter. Indeed, Broncoflex Agile has an applied part with a smaller diameter than the Broncoflex Vortex.

Broncoflex Agile and Vortex: This video-bronchoscope is intended to provide an optical display of the pulmonary tract using a monitor (Screeni®) and to be used with endotherapy accessories and instruments. This video-bronchoscope is designed for use exclusively in a hospital environment. Screeni: This device is designed for use exclusively in a hospital environment, in combination with an Axess Vision Broncoflex @ video-bronchoscope.

Broncoflex® Agile and Broncoflex Vortex are a single-use video-bronchoscope which is part of a system made up of the endoscope (Broncoflex) and its reusable display monitor (Screeni). The applied part of the medical device is the whole of the flexible tubing containing the insertion tube, the articulated section and the distal tip (BF type applied part: BF). Broncoflex is sterile and supplied ready to use in its sealed packaging (sterilization method ethylene oxide). The Screeni is a reusable non-sterile medical device and is a video processor with interface touch interface designed to display live imaging data captured by Broncoflex Agile and Broncoflex Vortex.