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Contents

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4. 2
5. 2 20091 IBC60601 i 1988 A1 1991 A2 1995 IEC60601 1 1 2000
6. 3 90 wedgethrombus
7. ISO10993 6 ASTM F67 95 Medical grade 2
8. 1SO 10993 1
9. AC DC 2
10. IEC IEC EN IH 3000 E 41
11. 1 2 3
12. 2 8
13. 20 12 25 20 8 5 NYHA New York Heart Association IV 1 Eric A Rose etal Long term use of a left ventricular assist device for end stage heart failure N Engl J Med Vo1 345 No 20 2001 1435 1443
14. 90 wvo ASAIO STS GLP 10 10 6 10 90 90 4 3 1
15. 2 2 41 3 41 3 17 122 16 169
16. HeartMate XVE QOL Quality of life 1997 1999 QOL
17. 3 22 10 29 7 VAHEART 21 1 19 22 10 29 7
18. E 23 1 E 30 1
19. 2 2 11 19 7 VAHEART 21 1 19 22 11 19 7 1 2
20. EVAHEART 2 90 80 88 1 2 1
21. 1 2 3 90 11 4
22. 12
23. 4 6 2 wedgethrombus
24. 22 10 29 1 7 VAHEART 21 1 19 2
25. 2 E 23 E 30 1 2
26. 41 3 CSU
27. 2 AC DC 1 3
28. OPTN Organ Procurement and Transplantation Network 2009 3500 2200 1997 10 2009 10 64 883 29 2747 228 670 17 2000 4000 2001 21300BZY00468000 2009 HeartMate XVE LVAS 221008ZY00011000 HeartMate XVE
29. EN60601 1 2 2001 ISO10993 1 SAL 10 25ug g 250ng g
30. 86 7 95 69 5 100 0 2010 10 19 924 1 526 1 1900 TT
31. EEVAHEART 21 1 19 3 3 15 6 15 13 Kaplan Meier 6

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