User's manual
8Pages

endalis User's manual end-ball Intra-gastric balloon system ENDT110

USER’S MANUAL 1. PREPARATION Perform a control endoscopy Important Note the distance between the mouth and the cardia from the markings on the endoscope Balloon et accessories : Balloon 50mL syringe Introduction system  Check the integrity of the medical device before use  Remove the protective tube around the balloon  Moisten the tip of the endoscope  Coat the balloon with surgical gel 2. INSERTION  The patient must be positioned in the left lateral position, the head in the axis of the spine, maintained by a pillow  Use the finger as a guide. Only hold the system by the external...

USER’S MANUAL  Passage through esophagus with the balloon continuously under endoscopic view  Position the balloon in the stomach, the mesial part of the introducer at least 5 cm from the cardia.  The introducer must have sufficient space to allow the deployment of the balloon without compressing the gastric wall.  The introducer must be visible in its entirety before beginning the inflation.  If the introducer is not visible in its entirety, reposition the introducer correctly 3. FILLING Connect the syringe to the non-return valve Non-return valve Inflating with air: • Inject at least...

USER’S MANUAL 4. RELEASING The balloon is now inflated External sheath Non-return valve • Hold the external sheath and the catheter separately • The balloon is blocked against the external sheath • There is no need to position the balloon against the cardia for the releasing • Pull until the balloon disconnects

USER’S MANUAL  Remove the system gently: o Firstly the endoscope o Secondly the catheter  Check the position and mobility of the balloon inside the stomach A control endoscopy is recommended to check the correct inflation of the balloon (bag under tension, smooth appearance, etc.) and the correct positioning and freedom of movement of the balloon in the gastric antrum.

USER’S MANUAL 5. EXTRACTION Universal Bi conical connector Accessories : Extraction hooks Hollow drainage needle Procedure :  Bring down the endoscope in the stomach and visualize the balloon  Position the catheter needle, perpendicularly at the contact of the balloon.

• Drill the balloon by pressing a sharp blow on the handle of the needle • Connect the catheter needle with the aspiration using the biconical connector • Wait until the balloon is completely deflated • Then remove the needle / catheter • Bring down the forceps extraction in the working channel • Secure the balloon with the hooks • Keep the balloon against the end of the endoscope

USER’S MANUAL  Bring slowly up the balloon through the cardia and along the esophagus.  The emptier the balloon is, the easier is the manoeuver  Perform endoscopic control to check if there are no affected areas after the passage of the balloon