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Permanent disability
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Heart failure
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Death
6. Instructions for use
6.1. Sterilization information
The Medtronic Open Pivot heart valve and package contents have been steam sterilized within the trays.
The valve is ready for use when received. Do not use the valve if:
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The Use-by date has expired
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The valve container (inner packaging) is damaged
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The sterility barrier is broken
The sizers and bendable handles are supplied nonsterile and must be cleaned and sterilized prior to use.
Refer to the Medtronic Open Pivot accessories Instructions for Use for cleaning and sterilization
instructions.
Warning: If the valve is removed from its container but not used, it must not be repackaged or resterilized.
6.2. Preparation for implant
Circulating nurse:
1. Remove the double barrier trays from the shipping box along with the Patient Registration Form.
2. Verify that the valve size, type, and serial number located on the tray label match the information on
the box label.
Note: Verify that the valve is attached to the valve holder before opening the outer tray. If the valve is
not attached to the valve holder, do not use the valve. Do not attempt to reassemble the valve onto the
valve holder.
3. Hold the outer tray and gently peel the lid back using sterile technique until the lid has been
completely removed from the tray.
4. Record the serial number of the valve in the patient's record using the stickers provided on the Patient
Registration Form.
Scrub nurse/surgeon:
1. Remove the inner tray from the outer tray by inserting a gloved finger into the open corner and lifting
the inner tray.
2. Holding the inner tray from the bottom, grasp the inner tray lid tab and peel back until it has been
completely removed.
3. Pick up the retainer using the textured areas. The inner tray retainer has textured areas on both ends.
4. Discard or recycle the retainer after it is removed.
Note: Do not remove the valve and holder from the tray.
5. Check that the valve holder is secured to the handle rotator. There should be no visible screw threads
at the connection between the colored handle rotator and the valve holder when secured properly.
Reference Figure 5 and Figure 6 for the position of an aortic valve and a mitral valve on the holder,
respectively. Do not use the valve if it is not properly secured to the holder.
6. Remove the blue leaflet actuator and set aside for later use.
7. Grasp the handle rotator in the center and gently lift the valve and valve holder out of the inner tray.
Caution: Do not remove the valve holder from the valve unless directed by the implanting surgeon.
Caution: Avoid touching the valve unnecessarily to prevent structural damage and to minimize the
potential for thrombus formation.
6.3. Surgical information
Valve sizing
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Prior to surgery, a complete set of Medtronic Open Pivot heart valve sizers and bendable handle must
be cleaned and sterilized per the accessories Instructions for Use and made available in the operating
room (Figure 7, Figure 8, and Figure 9).
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Do not use sizers that are damaged or cracked.
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Use only Medtronic Open Pivot heart valve sizers to measure the patient's tissue annulus. The
Medtronic Open Pivot heart valve sizer has a nitinol shaft that can be shaped allowing the same sizer
to be used for mitral or aortic annulus estimations.
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The diameter of the sizer is marked in millimeters. The sizer has a ring that allows easy tissue annulus
measurement. The ring should pass easily through the patient's tissue annulus with minimal
resistance. Do not force the sizer through the tissue annulus. Avoid valve oversizing or undersizing.
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AP Series (AP and AP360) valves are intended for supra-annular placement.
Valve holder
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The Medtronic Open Pivot heart valve is premounted on a holder and connected to a color-coded
handle rotator. Reference Figure 5 and Figure 6 for the position of an aortic valve and a mitral valve on
the holder.
Note: The blood flow in either the aortic or mitral position is always into the straight edge of the leaflets
(Figure 1, Figure 2, and Figure 3).
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The bendable handle (Figure 9) may be used if the surgeon desires a different angle for the valve
holder.
Instructions for Use
English
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