Registration Information; Disclaimer Of Warranty - Medtronic Open Pivot Gebrauchsanweisung

A green leaflet actuator, made of High Density Polyethylene (HDPE) and sterilized using irradiation, is also
included with the AVG. The green leaflet actuator is intended for ONE TIME USE ONLY.
The valve sizer set (not included) includes sizes 19–35 mm and a blue leaflet actuator (Figure 3). These are
intended for use only with the Medtronic Open Pivot Heart Valve and the AVG. Sizer sets are provided
NONSTERILE and must be cleaned and sterilized before each use. Both the valve sizers and blue leaflet
actuator can be reused with proper cleaning and sterilization as specified by the manufacturer.

10. Registration Information

Note: Patient registration does not apply in countries where patient privacy laws conflict with providing patient
information, including countries from the EU. 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 label. 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 AORTIC VALVED GRAFTS, 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 English 11