Medtronic Affinity Fusion BB811 Instrucciones De Uso página 28

purchaser equal to the Purchase price, as defined in Subsection A(2), against the purchase of
the replacement Product or (b) provide a functionally comparable replacement Product at no
charge.
(2) As used herein, Purchase Price shall mean the lesser of the net invoiced price of the original,
or current functionally comparable, or replacement Product.
B. To qualify for the LIMITED WARRANTY, these conditions must be met:
(1) The Product must be used prior to its "Use By" date.
(2) The unused portion of the Product must be returned to Medtronic and shall be the property of
Medtronic.
(3) The Product must not have been altered or subjected to misuse, abuse or accident.
(4) The Product must be used in accordance with the labeling and instructions for use provided
with the Product.
C. This LIMITED WARRANTY is limited to its express terms. In particular:
(1) Except as expressly provided by this LIMITED WARRANTY, Medtronic is not responsible for
any direct, incidental or consequential damages based on any defect, failure or malfunction of
the product, whether the claim is based on warranty, contract, tort or otherwise.
(2) THIS LIMITED WARRANTY IS MADE ONLY TO THE PATIENT ON WHOM THE PRODUCT
WAS USED. AS TO ALL OTHERS, MEDTRONIC MAKES NO WARRANTY, EXPRESSED
OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF
MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE, WHETHER ARISING
FROM STATUTE, COMMON LAW, CUSTOMER OR OTHERWISE. NO EXPRESS OR
IMPLIED WARRANTY TO THE PATIENT SHALL EXTEND BEYOND THE PERIOD
SPECIFIED IN A(1) ABOVE. THIS LIMITED WARRANTY SHALL BE THE EXCLUSIVE
REMEDY AVAILABLE TO ANY PERSON.
(3) The exclusions and limitation set out above are not intended to, and should not be constructed
so as to contravene mandatory provisions of applicable law. If any part or term of this LIMITED
WARRANTY is held to be illegal, unenforceable or in conflict with applicable law by a court of
competent jurisdiction, the validity of the remaining portions of the LIMITED WARRANTY shall
not be affected, and all rights and obligations shall be construed and enforced as if this
LIMITED WARRANTY did not contain the particular part or term held to be invalid. This
LIMITED WARRANTY gives the patient specific legal rights. The patient may also have other
rights which vary from state to state.
(4) No person has any authority to bind Medtronic to any representation, condition or warranty
except this LIMITED WARRANTY.
Note: This LIMITED WARRANTY is provided by Medtronic, Inc. 710 Medtronic Parkway,
Minneapolis, MN 55432. It applies only in the United States.
13. Important Notice — Limited Warranty (For Countries Outside the U.S.)
A. This LIMITED WARRANTY provides assurance for the purchaser who receives an Affinity
Fusion ® Oxygenator with Integrated Arterial Filter and Balance
as the "Product", that, should the Product fail to function to specification, Medtronic will issue a
credit, equal to the original Product purchase price (but not to exceed the value of the replacement
Product) against the purchase of any Medtronic replacement Product used for that patient.
The Warnings contained in the product labeling are considered an integral part of this LIMITED
WARRANTY. Contact your local Medtronic representative to obtain information on how to process
a claim under this LIMITED WARRANTY.
B. To qualify for the LIMITED WARRANTY, these conditions must be met:
(1) The Product must be used prior to its "Use By" date.
(2) The Product must be returned to Medtronic within 60 days after use and shall be the property
of Medtronic.
(3) The Product may not have been used for any other patient.
C. This LIMITED WARRANTY is limited to its express terms. In particular:
(1) In no event shall any replacement credit be granted where there is evidence of improper
handling, improper implantation or material alteration of the replaced Product.
(2) Medtronic is not responsible for any incidental or consequential damages based on any use,
defect or failure of the Product, whether the claim is based on warranty, contract, tort or
otherwise.
D. The exclusions and limitations set out above are not intended to, and should not be construed so
as to, contravene mandatory provisions of applicable law. If any part or term of this LIMITED
WARRANTY is held by any court of competent jurisdiction to be illegal, unenforceable or in conflict
with applicable law, the validity of the remaining portion of the LIMITED WARRANTY shall not be
26 Instructions for Use English
® Biosurface, hereafter referred to