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Patient Registration Form
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Blue leaflet actuator
All packaging materials are recyclable. Manage disposal in accordance with local statutory regulations.
8.2. Storage
For maximum protection and product identification, it is recommended that the valve be stored in its
original packaging. The storage environment should be clean, cool, and dry. The sterility and
nonpyrogenicity of the valve is validated to remain unaffected until the Use-By Date printed on the product,
provided the seals and containers are not opened or damaged.
8.3. Returned product information
For detailed information on the Medtronic Return Product Policy, please contact your local representative.
9. Accessories
A color-coded rotator is included with each valve (Figure 5 and Figure 6). Use only the supplied rotator
because the rotator is matched to the valve size and position.
The Medtronic Open Pivot™ heart valve sizer sets and bendable handles are intended for use only with
Medtronic Open Pivot heart valves (Figure 7, Figure 8, and Figure 9). Medtronic Open Pivot™ accessories
are provided nonsterile and must be cleaned and sterilized before each use. Refer to the Medtronic Open
Pivot accessories Instructions for Use for cleaning and sterilization instructions.
The blue leaflet actuator supplied with each package is used to test for free leaflet motion after the valve
has been implanted.
10. Patient information
10.1. Registration information
Note: Patient registration does not apply in countries where patient privacy laws conflict with providing
patient information, including countries from the European Union. A patient registration form is included in
each device package. After implantation, please complete all requested information. The serial number
may be found on the tray and box labels. Return the original form to the Medtronic address indicated on
the form and provide the temporary identification card to the patient prior to discharge.
An Implanted Device Identification Card is provided to the patient. The card contains the name and
telephone number of the patient's physician, as well as information that medical personnel would require
in the event of an emergency.
11. Disclaimer of warranty
THE FOLLOWING DISCLAIMER OF WARRANTY APPLIES TO CUSTOMERS OUTSIDE THE UNITED
STATES:
ALTHOUGH THE MEDTRONIC OPEN PIVOT HEART VALVES, HEREAFTER REFERRED TO AS
"PRODUCT," HAVE BEEN CAREFULLY DESIGNED, MANUFACTURED, AND TESTED PRIOR TO
SALE, THE PRODUCT MAY FAIL TO PERFORM ITS INTENDED FUNCTION SATISFACTORILY FOR
A VARIETY OF REASONS. THE WARNINGS CONTAINED IN THE PRODUCT LABELING PROVIDE
MORE DETAILED INFORMATION AND ARE CONSIDERED AN INTEGRAL PART OF THIS
DISCLAIMER OF WARRANTY. MEDTRONIC, THEREFORE, DISCLAIMS ALL WARRANTIES, BOTH
EXPRESS AND IMPLIED, WITH RESPECT TO THE PRODUCT. MEDTRONIC SHALL NOT BE LIABLE
FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES CAUSED BY ANY USE, DEFECT, OR
FAILURE OF THE PRODUCT, WHETHER THE CLAIM IS BASED ON WARRANTY, CONTRACT,
TORT, OR OTHERWISE.
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 DISCLAIMER OF
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 DISCLAIMER OF WARRANTY shall not be
affected, and all rights and obligations shall be construed and enforced as if this DISCLAIMER OF
WARRANTY did not contain the particular part or term held to be invalid.
Instructions for Use
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