Medtronic Open Pivot Instrucciones De Uso página 17

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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 reusable 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 matches 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 reusable 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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Sizers that are damaged or cracked must not be used.
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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 sizer with the diameter marked in millimeters has a ring which allows easy tissue annulus
measurement. The sizer ring should pass easily through the patient's tissue annulus with minimal
resistance. Do not force the sizer through the tissue annulus. Valve oversizing or undersizing should be
avoided.
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AP Series (AP, APex, 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. 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, reusable handle (Figure 9) may be used if the surgeon desires a different angle for the
valve holder.
Cuff Suturing
Instructions for Use English 15