Medtronic 505DA20 Instructions for Use
Medtronic Open Pivot™
Heart Valve
500, 501, 505
Instructions for Use
Caution: Federal law (USA) restricts this device to sale by or on the
order of a physician.
Trademarks may be registered and are the property of their respective owners.
Explanation of symbols on package labeling
Refer to the device labeling to see which symbols apply to this product
Nonpyrogenic
Sterilized Using Steam
Size
Do Not Reuse
Do Not Resterilize
Use-By Date
Quantity
Open Here
Consult Instructions for Use
For US Audiences Only
Keep Dry
Date of Manufacture
Serial Number
Catalog Number
Manufacturer
Authorized Representative in the European Community
MR Conditional
Do Not Use if Package is Damaged
Manufactured In
1
1
2
3
4
5
9
7
6
8
5
7
8
9
6
1. Inside diameter
2. Geometric orifice
3. Mitral valve
4. Aortic valve
5. Profile height
6. Inflow height
7. Outflow height
8. Tissue annulus
9. Blood flow
Figure 1. Standard heart valve
2
1
3
4
2
5
5
7
9
9
7
6
8
8
6
1. Inside diameter
2. Geometric orifice
3. Mitral valve
4. Aortic valve
5. Profile height
6. Inflow height
7. Outflow height
8. Tissue annulus
9. Blood flow
Figure 2. AP™ heart valve
3
1
2
9
7
6
5
3
4
5
8
9
6
7
8
1. Inside diameter
2. Geometric orifice
3. Mitral valve
4. Aortic valve
5. Profile height
6. Inflow height
7. Outflow height
8. Tissue annulus
9. Blood flow
Figure 3. AP360™ heart valve
4
1
3
2
5
9
7
6
8
4
1. Outer lid
2. Inner lid
3. Retainer
4. Leaflet actuator
5. Heart valve
6. Valve holder
7. Handle rotator
8. Inner tray
9. Outer tray
Figure 4. Double barrier tray package
5
1
Figure 5. Aortic valve holder and handle rotator assembly (leaflets inside holder)
1
1. Radial ridge
1. Radial ridge
Figure 6. Mitral valve holder and handle rotator assembly
6
Figure 7. Standard heart valve sizer
7
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