Medtronic Open Pivot Instrucciones De Uso página 14

Medtronic Open Pivot™
Heart Valve
1. Device Description
The Medtronic Open Pivot Heart Valve (Models 500, 501, 503, and 505) orifice and leaflets are constructed
of pyrolytic carbon. The sewing cuff is constructed of titanium or cobalt chrome, and polyester fabric. The
Medtronic Open Pivot Heart Valve is available in the aortic and mitral configurations in several sewing cuff
styles, the Standard, AP, APex, and AP360. The AP Series valves are supra-annular configurations of the
Standard Heart Valve. The valves are available in the dimensions and sizes shown in Table 1
through Table 5.
Table 1. MEDTRONIC OPEN PIVOT STANDARD HEART VALVE SPECIFICATIONS
Valve Size Model
(mm) Number
AORTIC
19 500FA19
21 500FA21
23 500FA23
25 500FA25
27 500FA27
29 500FA29
31 500FA31
MITRAL
19 500DM19
21 500DM21
23 500DM23
25 500DM25
27 500DM27
29 500DM29
31 500DM31
33 500DM33
Table 2. MEDTRONIC OPEN PIVOT AP360 HEART VALVE SPECIFICATIONS
Valve Size Model
(mm) Number
AORTIC
16 505DA16
18 505DA18
20 505DA20
22 505DA22
24 505DA24
26 505DA26
28 505DA28
MITRAL
16 505DM16
18 505DM18
20 505DM20
22 505DM22
24 505DM24
26 505DM26
28 505DM28
Table 3. MEDTRONIC OPEN PIVOT AP HEART VALVE SPECIFICATIONS
Valve Model Num-
Size ber
(mm)
AORTIC
16 501DA16
18 501DA18
20 501DA20
22 501DA22
24 501DA24
12 Instructions for Use
Overall Inflow Pro-
Profile file Height
Height (mm)
(mm)
9.3 2.4
10.3 2.9
11.3 3.4
12.3 3.4
13.3 3.4
14.3 3.9
15.4 4.6
9.3 3.0
10.3 3.0
11.3 3.0
12.3 3.3
13.3 3.7
14.3 3.7
15.4 3.7
15.4 3.7
Overall Inflow Pro-
Profile file Height
Height (mm)
(mm)
9.3 1.5
10.3 1.5
11.3 1.5
12.3 1.5
13.3 1.5
14.3 1.5
15.4 1.5
9.3 4.8
10.3 5.3
11.3 5.8
12.3 6.3
13.3 6.7
14.3 7.2
15.4 7.7
Overall Inflow Pro-
Profile file Height
Height (mm)
(mm)
9.3 1.5
10.3 1.5
11.3 1.5
12.3 1.5
13.3 1.5
English
Outflow Inside
Profile Diameter
Height I.D. (mm)
(mm)
6.9 14.8
7.4 16.8
7.9 18.8
9.2 20.8
9.9 22.8
10.4 24.8
10.8 26.8
6.3 14.8
7.3 16.8
8.3 18.8
9.0 20.8
9.6 22.8
10.6 24.8
11.7 26.8
11.7 26.8
Outflow Inside
Profile Diameter
Height I.D. (mm)
(mm)
7.8 14.8
8.8 16.8
9.8 18.8
10.8 20.8
11.8 22.8
12.8 24.8
13.9 26.8
4.5 14.8
5.0 16.8
5.5 18.8
6.1 20.8
6.6 22.8
7.1 24.8
7.7 26.8
Outflow Inside
Profile Diameter
Height I.D. (mm)
(mm)
7.8 14.8
8.8 16.8
9.8 18.8
10.8 20.8
11.8 22.8
Tissue Geometric
Annulus Orifice
Diameter
Area (cm
(mm)
19.2 1.55
21.2 2.02
23.2 2.56
25.2 3.17
27.2 3.8
29.2 4.59
31.2 5.35
19.2 1.55
21.2 2.02
23.2 2.56
25.2 3.17
27.2 3.84
29.2 4.59
31.2 5.35
33.2 5.35
Tissue Geometric
Annulus Orifice
Diameter Area (cm
(mm)
16.2 1.55
18.2 2.02
20.2 2.56
22.2 3.17
24.2 3.84
26.2 4.59
28.2 5.35
16.2 1.55
18.2 2.02
20.2 2.56
22.2 3.17
24.2 3.84
26.2 4.59
28.2 5.35
Tissue Geomet-
Annulus ric Orifice
Diameter Area
(mm) (cm 2 )
16.2 1.55
18.2 2.02
20.2 2.56
22.2 3.17
24.2 3.84
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