Caution PTCA Catheter

Caution: The Federal law restricts this product to sale by or on the order of a physician
1. Instruction for Use
1.1 Description of the device
1) This PTCA catheter is a therapeutic catheter with drug delivering balloon located at the distal tip.
2) One of the lumen is for inflation of the occlusion balloon and other is for medication through the semi compliant balloon and the other is for the guide wire.
3) The occlusion balloons has two radio markers so that the balloon can be positioned at the right spot
4) The balloon is dilated using the port, the expansion of the balloon happens at certain pressure. The working pressure is between the nominal pressure and the rated burst pressure.
5) The PTCA catheter is …show more content…
Preparation and use
1) It is advisable to check the packaging for any damage before use. The integrity of the device must be checked to make sure there are no leakages from any of the joints. The occlusion balloon should be partially inflated to check its inflating.
2) Before the introduction of the catheter the balloon protection tubing should be removed completely.
3) Place the catheter with a positioned guide wire at the site of introduction. Perform all further catheter procedure under fluoroscopy.
4) Position the catheter balloon at the center of the stenosis with the help of the radiopaque marker bands.
5) When the acceptable position of the balloon is reached inflate the occlusion balloon to the desired pressure but make sure it does not cross the rated burst pressure as it may damage the balloon and even the catheter.
6) Inflate the semi compliant balloon using the medication and inflate it till required amount of medication is delivered.
7) Deflate the balloon after the intended time period of inflation.
8) Withdraw the balloon while maintaining the vacuum in the balloon. If the balloon cannot be withdrawn from the sheath then remove the balloon and sheath as one unit.
9) Check the results by

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