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21. Using fluoroscopy and TEE or TTE, verify the position of the device and that there is
no unintentional interference with the valve function (leaflet obstruction,
regurgitation, etc.), or obstruction of the coronary arteries.
22. If the device position is unsatisfactory:
- Stabilize the wire and re-advance the delivery catheter until the device is
recaptured within the catheter.
- Reposition and redeploy the device, or remove the device from the patient.
23. If the device position is satisfactory:
- Attach the plastic vise to the delivery wire, and detach the device by rotating the
delivery wire counterclockwise until it separates from the device.
- Remove all delivery system components from the patient.
Disposal
• The carton and Instructions for Use are recyclable. Dispose of all packaging materials
as appropriate.
• Devices can be returned to Abbott Medical for disposal. Contact an Abbott Medical
representative or returns@amplatzer.com for instructions.
• Use solid biohazard waste procedures to discard devices.
Warranty
Abbott Medical 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. Abbott Medical'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 Abbott Medical and after confirmed to be defective by the manufacturer.
EXCEPT AS EXPRESSLY PROVIDED IN THIS WARRANTY, ABBOTT MEDICAL
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.
Australian Warranty
This section is only provided in English.
This warranty is given by Abbott Medical. To make inquiries regarding this warranty, use the
contact information for either the manufacturer or Australian Sponsor.
Our goods come with guarantees that cannot be excluded under the Australian Consumer
Law. You are entitled to a replacement or refund for a major failure and compensation for any
other reasonably foreseeable loss or damage. You are also entitled to have the goods
repaired or replaced if the goods fail to be of acceptable quality and the failure does not
amount to a major failure.
The benefits to you given by this warranty are in addition to your other rights and remedies
under the Australian Consumer Law.
Abbott Medical warrants to the buyer that the goods, for a period equal to the validated shelf
life of the goods (the "Warranty Period"), 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. Unless otherwise obligated by law
or mandatory consumer guarantees, under this warranty Abbott Medical will, at its option,
replace or repair the goods at its factory, if the buyer, at the buyer's expense, returns the
goods within the Warranty Period to Abbott Medical at the address provided with the product
and after Abbott Medical confirms that the goods are defective.
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