How Supplied; Patient Information; Registration Information; Disclaimer Of Warranty - Medtronic Open Pivot Instrucciones De Uso

Model 505:
Pulse Sequence
Signal Void Size
Plane Orientation
Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be
necessary.

8. How Supplied

8.1. Packaging
The Medtronic Open Pivot Heart Valve is packaged in sterile transparent double barrier trays. The valve is
premounted on a holder and attached to a handle/rotator. All package labeling and handle/rotator
accessories are color-coded and marked:
■
Aortic – Green
■
Mitral - Red
The valve package (Figure 4) includes:
■
Outer Tray
■
Inner Tray
■
Inner Tray Retainer
■
Valve, Valve Holder, Handle/Rotator Assembly
■
Instructions for Use
■
Patient Registration Form
■
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). Only use 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.
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 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 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
T1-SE
2,257 mm 2
Parallel
T1-SE
724 mm 2
Perpendicular
GRE
4,244 mm 2
Parallel
Instructions for Use
GRE
2,327 mm 2
Perpendicular
English 17