Filling
- To remove the air from the balloon, please follow the instructions below:
- Connect an inflation device to the Luer-Lock and hold the catheter tip down.
- Apply vacuum and keep for at least 30 seconds.
- Lock the stop-lock lever to keep both the balloon and the catheters free from air.
- Disconnect the inflation device from the balloon and fill it completely with liquid.
- Recommended liquids are sterile, isotonic saline solution; Sterile low viscosity contrast media or a mixture of both.
- Keep vacuum during insertion in the endoscope
- Essential volume of air in the system may result in inconsistent expansion of the balloon. If this is recognized, repeat filling steps.
- Allowing air or liquid to fill the balloon before entering the working channel of the endoscope may prevent the device to be inserted and therefore the procedure cannot be completed.
Application
- Slowly introduce the balloon catheter into the endoscope’s working channel. It can be used over a 0,035”guide wire.
- Due to different endoscope specifications and types, there may be higher resistance when initially inserting the catheter into the endoscope and approx. 2 to 3 cm from the working channel’s distal end.
- Advance the balloon under endoscopic control to its final position.
- Fill the balloon using an appropriate inflating device.
- Never fill the balloon with any gas!
- Never exceed the given maximum inflation pressure. In case of a balloon burst or a liquid leakage, empty the balloon and remove it carefully together with the endoscope. Don’t try to pull the burst balloon back into the endoscope. Start with a new balloon again.
- After reaching the indicated balloon diameter, adjust the balloon pressure as necessary (do not exceed maximum inflation pressure). After the inflator device has been set to working pressure the pressure gauge will indicate slightly decrease of pressure because of pressure equalization in the catheter system. After a few seconds, the indication should stabilize.
- Keep pressure till the requested dilation is reached.The pressure indication may fluctuate during dilation.
- After dilation deflate the balloon slowly. This may take approx. 20 to 30 seconds depending on the size and liquid.
- To deflate completely, the proximal end of the balloon must be visible in the endoscope during vacuum application. Remove the catheter only if completely empty.
- Keep the endoscope as straight as possible. Every curve increases wall friction and difficulty to remove the catheter.
- Pull the catheter slowly out of the endoscope. If unusual resistance is recognized, remove the endoscope and balloon together to avoid patient injury or damage on the endoscope.
- After use, dispose of the entire instrument according to legal requirements and your facility’s infection control protocols.