Amplatzer Duct Occluder II Gebrauchsanweisung Seite 8

4. Use angiography to measure the diameter (D) and length (E) of the PDA. Refer to
figure F3 for measurement locations.
WARNING: Accurate measurement of the PDA is critical for correct occluder
selection.
5. Use the PDA measurements to find the correct occluder size in table T2.
6. Prepare the device for use.
- Inspect the sterile pouch.
CAUTION: Do not use the device if the sterile pouch is open or damaged.
- Open the sterile pouch. Inspect the device.
7. Prepare the catheter according to the manufacturer's instructions for use.
8. Move the catheter forward over the guidewire and through the ductus.
9. Do a test injection with contrast medium to see the position of the catheter.
10. Move the proximal end of the delivery wire forward through the distal end of the
loader and through the self-sealing hemostasis valve.
11. Make sure the occluder is threaded tightly onto the delivery wire. Turn the occluder
counterclockwise 1/8 of a turn to make disconnection easier.
CAUTION: Do not overtighten the connection.
12. Put the occluder and the loader in sterile saline. Retract the occluder into the loader.
13. Flush the loader and the occluder with sterile saline through the self-sealing
hemostasis valve.
14. Remove the guidewire.
15. Permit blood backflow through the Tuohy-Borst hemostasis valve to remove air from
the system.
16. Move the loader forward through the Tuohy-Borst hemostasis valve and into the
catheter until the loader stops.
17. Tighten the Tuohy-Borst hemostasis valve onto the loader.
18. Hold the catheter, hemostasis valve, and loader as a single unit. Move the implant
forward from the loader into the catheter.
CAUTION: Move the implant carefully to prevent damage to the vessels or cardiac
tissue.
Note: If it is difficult to transfer the implant into the catheter, recapture the implant in
the loader and adjust the position of the loader.
19. Move the occluder forward to the distal tip of the catheter.
CAUTION: Do not turn or twist the delivery wire.
20. Hold the delivery wire and retract the catheter to deploy the distal disc.
WARNING: Do not push the delivery wire to deploy the occluder.
21. Retract the catheter and delivery wire as one unit until the distal retention disc of the
occluder touches the vessel wall at the PDA.
22. Use angiography or echocardiography to make sure the distal retention disc of the
occluder is placed correctly against the vessel wall.
23. Stabilize the delivery wire and slowly retract the catheter to deploy the waist of the
occluder inside the PDA. The waist of the occluder must appose the ductus wall.
24. Stabilize the delivery wire and slowly retract the catheter to deploy the proximal
retention disc.
25. Do an aortic angiogram.
- Make sure the occluder is in the correct position.
- Make sure the occluder is stable.
- Make sure the occluder shape is correct.
- Measure occlusion of the PDA.
3