Amplatzer Amulet Gebrauchsanweisung Seite 11

100105566_Amulet.book Page 4 Tuesday, May 20, 2014 1:05 PM
11. Fill a 35-cc syringe with sterile saline. Connect the syringe to the hemostasis valve.
Submerse device in the sterile saline. Flush sterile saline through the loader and
simultaneously tighten the hemostasis valve onto the delivery cable. Fill the syringe and
flush sterile saline through the loader 2 more times.
Note: During additional flushing ensure air does not enter the system.
Note: The loader tubing may be massaged to help remove air.
Note: During steps 11–15 make sure the tip of the loader is submerged in sterile saline at
all times so air does not enter the loader.
12. Fully retract the syringe plunger while holding the syringe body. Allow time for sterile
saline to completely fill the syringe.
13. Advance the syringe plunger to force sterile saline through the loader.
Note: During this process, a small amount of air may accumulate in the syringe. Ensure
the syringe is held upright and no air is introduced back into the loader.
14. Flush the device again using steps 12 and 13.
Note: If air is visible in the loader, additional flush steps may be performed as described in
steps 11-14 or the device may be removed from the loader and disconnected from the
delivery cable. Reload the device by performing steps 34–43.
WARNING: Do not retract the device.
15. Retract the plunger to fill the syringe with sterile saline to accommodate fluid-to-fluid
connection with the delivery sheath.
16. Ensure the device is attached to the delivery cable by rotating the delivery cable/delivery
cable vise clockwise until resistance is felt.
17. Advance the dilator and delivery sheath over the guidewire to the entrance of the left
atrial appendage. Retract the dilator until it is inside the sheath tip. Position the sheath tip
slightly beyond the landing zone of the left atrial appendage.
WARNING: Use caution when advancing the dilator and sheath to prevent trauma.
18. Slowly remove the dilator from the delivery sheath. Remove the guidewire from the
patient.
19. If a 14 Fr delivery sheath was selected for use with a 16 mm
connect the 14 Fr sheath adaptor to the delivery sheath hub.
WARNING: Proximal adaptor end is only compatible with supplied loader fitting. Do not
flush or aspirate with any other accessories.
20. Allow blood backflow to purge all air from the delivery sheath assembly by holding the
hub below the plane of the patient's body.
21. Immediately connect the loader to the delivery sheath in a fluid-to-fluid fashion and
tighten the rotating luer.
22. Slightly loosen the hemostasis valve. Introduce the device into the delivery sheath and
advance the device to the tip of the delivery sheath. Look for air bubbles when advancing.
If air is present, allow backflow to purge air from the delivery sheath assembly.
WARNING: Aspirating is not recommended because air can be introduced into the
system.
WARNING: Do not rotate the delivery cable when advancing the device through the
delivery sheath.
23. Use fluoroscopy and echocardiography to guide the device into the left atrial appendage.
WARNING: If the device needs to be retracted after this point, the device and sheath
must both be removed and replaced.
Note: Delivery cable connection can be checked by rotating the delivery cable/delivery
cable vise clockwise until resistance is felt.
24. Hold the delivery cable in place while retracting the delivery sheath to partially expose the
lobe (see F3). If necessary, adjust the position of the sheath and lobe for alignment.
25 mm device, tightly
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