Amplatzer Duct Occluder II Gebrauchsanweisung Seite 9

Note: The discs should not protrude or bulge into the vessels. Refer to figure F4 for
an example of the correct shape for a deployed occluder. Refer to figure F5 for an
example of an incorrectly deployed occluder.
WARNING: Do not release the occluder from the delivery wire if a retention disc
extends into a vessel or if the occluder is not stable. To recapture the occluder, move
the catheter forward over the occluder. Redeploy the occluder or replace it with a
new occluder.
CAUTION: Recapture and redeploy the occluder a maximum of 2 times. If the
position of the occluder is still unsatisfactory after the second deployment, remove
and replace the occluder and the catheter.
26. Connect the vise to the delivery wire. Turn the vise counterclockwise to disconnect
the occluder from the delivery wire.
WARNING: Do not push the delivery wire forward after the occluder is released.
27. Remove the delivery wire and the catheter.
WARNING: Slowly remove the catheter from the patient to prevent the introduction
of air.
Post-procedure care
• Monitor the patient overnight. Do a transthoracic echocardiogram to make sure the
occluder is in the correct position before the patient is released.
• Give endocarditis prophylaxis for 6 months. Prophylaxis beyond 6 months is at the
physician's discretion.
Post-procedure Instructions
• Go to www.amplatzer.com/tempIDcard to print a temporary patient identification card.
Complete this card and give it to the patient.
• To receive a permanent patient identification card, complete the implant registration
form and send it to AGA Medical.
Disposal
• The carton and instructions for use are recyclable. Discard all packaging materials
appropriately.
• Devices can be returned to AGA Medical for disposal. Contact an AGA Medical
representative or returns@amplatzer.com for instructions.
• Use solid biohazard waste procedures to discard devices.
Warranty
AGA Medical Corporation warrants to buyer that, for a period equal to the validated shelf life
of the product, this product shall meet the product specifications established by the
manufacturer when used in accordance with the manufacturer's instructions for use and shall
be free from defects in materials and workmanship. AGA Medical Corporation's obligation
under this warranty is limited to replacing or repairing at its option, at its factory, this product if
returned within the warranty period to AGA Medical Corporation and after confirmed to be
defective by the manufacturer.
EXCEPT AS EXPRESSLY PROVIDED IN THIS WARRANTY, AGA MEDICAL
CORPORATION DISCLAIMS ANY REPRESENTATION OR WARRANTY OF ANY KIND,
EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY AS TO MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE.
See the Terms and Conditions of Sale for further information.
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