"取扱説明書"
Contents
1. 194 gt 20 4 4 04040022. 3 5 1 2 120mmHg 8L min HeartMate VE 10 L min Novacor LVAS 8 5L mn
3. USB USB
4. 182
5. 4 2 1 1 5 1 4 2 1 6 1 3 5 2 5 HA Er E dn 0 HB XA 2D Er CR PESE LCV v5 BAERT HRL Cv sS AEE EO TFC Novacor LVAS HeartMate VE DeBakey VAD DeBakeyVAD Jarvik 2000 6 2 5m 1 4m
6. 1750rpm 600mA 6L min Het Het HeartMate VE Novacor LVAS DaeBakey VAD Jarvik 2000 Umin 3 5 1 5 10mm HeartMate VE 12 5mm Novacor LVAS 14 5 11 2mm T
7. 24 20900BZYO0255000 2 5
8. 0 40 10 9596RH 700 1060OhPa 20 50 10 85 RH HELL 181 0 40 10 9596RH 700 1060hPa 20 50C 10 95 RH
9. AC AC CAN 15V 5V CAN CAN CAN USB AC
10. 183 10 407C 30 7594RH AEL L T00 1060hPa 20 50 C 10 90 RH 20 60 10 80 RH f amp g8R722 7 B 1 0 40 10 9596RH 700 1060hPa REFF AMEE 0 30 lt 85 RH ARELL S
11. c F d Wh T e D g d p 4 2 2 1 1 4 2 2 1 1 4 2 2 1 1 4 2 2 1 1
12. Qo 2 LH 1 1 1 1
13. Novacor LVAS lt 2 5m HeartMate VE DeBakey VAD 2 3m Jarvik 2000 2 0m Novacor LVAS gt 1 5m HeartMate VE 71 5 m DeBakey VAD 7 1 3m Jarvik 2000 71 2m Jarvik 2000 1 2 x8 2250g Novacor LVAS 3415g HeartMate VE 1645g Jarvik 2000 875g DeBakey VAD 204 9
14. 1 2 2 ES 2 2 2 LEJERE
15. DeBakey VAD jarvik 2000 TRLPE2 4 5E Novacor LVAS HeartMate VE SR MARE 3 5
16. lt H SAL gt ISO 10993 7 ISO 10993 ISO 10993 30 4 4 0404002 ISO 10993 7 3 3 8
17. 197 3 a 2400rpm 8 0 8 2L min WEE AcP 1 5 2 9 6 1 6 9 4 2 2 7 1 3 1 3 3 4 2 1 6 2 4 2 1 6 3 4 2 1 6 6 4 2 2 5 2 4 2 2 6 1 4 2 26 2
18. 3 3 3 2 3 3 3 2 STED 1 2 3 1 4 1 1 3 1 2 3 1 4 3 1 1 3 1 2 aes fe IE 6 3 5 QO
19. dn Movacor HeartMate DeBakey DuraHeart Jarvik 2000 BEL CA A CEN por po ies oos NR o EZRA Jossa imeem 1 Um i tE 2001 8 31 CREE dE E 21300BZYO AER E aee E DN RA EE o mi 25 mL ER me da H amp 202 mS min 7 EDI F A oii 1 Het 35 2x 1 8E 9 477 Aii E A E CR OO EH 27 3 Ec ERA ADARA TES 1980
20. Bild n 7 ASTM F1841 97 2005 amp F fife LC 6 2 4 2 2 1 1 HERH 1 4 2 2 1 1 HE 4 2 2 1 1 1 4 2 2 1 1 199 a b
21. 3 LAC AC 0 40 C 10 959 RH 7T00 1060hPa 20 50 10 95 RH REELL Hct
22. Hct 3 5 1 4 205 Baxter Healthcare Corporatiomn A Solution for Long Term Circulatory Support Baxter Healthcare Corporation COMPORNENT SPECIFICATIONS NOVACOR LEFT VENTRICULAR ASSIST SYSTEM World Heart Inec Operators Manual Novacor LVAS United States Patent 4143661 POWER SUPPLY FOR BODY IMPLANT AND METHOD FOR OPERATION United States Patent 4167046 BLOOD PUMPING DEVICE R Jarvik V Scott M Morrow and E Takeuchi Artificial Organs 23 6 487 489 1999 Belt Worn Control System and Battery for the Percutaneous Model of the Jarvik 2000 Heart Westaby et al Circulatory Support for Treatment of Heart Failure June 4 2588 2581 2002 Circulatory Support for Long Term Treatment of Heart Failure Experience With an Intraventricular Continuous Flow Pump Timothy J Myers et al Ann Thorac Surg 75 879 85 2003 Continuous Flow Pumps and Total Artificial
23. 2 2 1 15 2 Lm o ww 201 3 5 MEER LVAS Novacor LVAS CE
24. SmmX1 2m Naovacor LVAS 14 5mm X 0 36m 11 2mm X 0 95m CHH HeartMate VE X 12 5mm X 1m iz Jaryik 2000 3 5 1 5 Jarvik2000 10 2 5 8L min Novacor LVAS 8 5L min HeartMate VE 10L min DeBakey VAD lt 10L min Jarvik 2000 6L min Noyacor LVAS 8X3E7ZL HeartMate VE EEL DeBakey VAD TL Jarvik 2000 1L min
25. jarvik 2000 DeBakey VAD 7000 11000rpm 1500 1750rpm 4 7L min 250 mmHg g Umin 207 3 5 1 3 Jb DuraHeart 2 000rpm s DuraHeart 1 800rpm DeBakey 12 000rpm Jarvik 13 250rpm mmHg L min 208 3 5 1 4 A db HE
26. 1 ALERE DEB min cm DEB min cm ISO 7198 1998 E 5 3 ISO 7198 1998 E 7198 5 2 Pa ELE 1 Ea x 191 dhi dBA 14708 1 232 dd 000 NES ISO 14708 1 23 2 192 gt SR IEC 60601 1
27. 1200 2400rpm A ETA b f c HE 4 2 1 6 4 d 4 2 1 1 1 2 4 2 2 1 6 3 1 7 3 1 7 1 e GEHE
28. IEC 60601 1 2 20um 1000 fl mL ISO 14708 1 14 2 5 0 um 100 fil mL Amendment1 1991 Amendment 2 1995 IEC 60601 1 2 2007 hi Hi BRE TR Ea ISO 14708 1 23 2 bn USP gt FDA s 1987 Guideline on USP FDA 1987 validation of the 20 EU device ILimuluns Amebocyte Lysate Test 193 lt SAL 10
29. 10 209 3 5 2
30. ilic ag b e 188 1200rpm 1800rpm 2400rpm x y z lH o NEe 5 ag b cu e M Uem i DEAE OR TADH B U cm E M noe IN Apka DET ERA ISO 7198 1998 E inii
31. 3 5 1 2 11 DeBakey VAD Jarvik 2000 Novacor LVAS HeartMate VE x12 Novacor LVAS HeartMate VE DeBakey VAD Jarvik 2000
32. 1 x RN 1 0mm 2 5 E 190 ISO 7198 1998 E 5 4 ISO 7198 1998 E 5 3 ISO 7198 1998 E 5 2 ISO 7198 1998 E 5 2 4 ko 7 ko ISO 7198 1998 E 5 1 ISO 7198 1998 E 5 5 xxm oW E pA B 1i FH nT 30cm ISO 7198 1998 E 5 4 ISO 7198 5 3 3o Tir T ATRE N ISO 719805 5 2 16kPa
33. in vitro 6 5L mn 100mmHg N LH 0 05mg dL 187 1200rpm 1800rpm 2400rpm x y z 30 Hz cov NEN NN RN DS S PSD aj 4 1 a b infa b ec 1 000 mL 100 mL 1200rpm 1800rpm 2400rpm
34. 4 2 2 7 1 b DERD 4 2 1 2 4 2 2 5 1 4 2 2 6 5 4 2 2 6 6 4 2 2 6 7 4 2 2 6 8 LIO EEBHSAEEMR BER d 4 2 1 2 e t 198 4 2 1 6 5 g 4
35. ISO 10993 1 JIS T0993 5 ASTMF1841 97 6 f BERE R5 15014708 1 IEC60601 1 4 2 1 2 7 22351 SR PE GO PAL PESANRD 4 2 1 6 4 FTAA In vivo ISO14708 5 ISO 10993 1 ISO 10993 4 ke a a 4 2 2 1 1 b 4 2 2 1 1 c 4 2 2 1 1 1 60 PAA 2 ISO TC150 SC6 WG6 Electromechanical Cardiac HPEH LAR Circulatory Systems 60
36. S 4 2 2 2 2 42223 REN b dini amp zh Pda dB PEBVXXxb7 FTP 2 1 2 2 4 2 2 2 2 4 2 2 2 3 c TE ATADA 4 2 1 1 5 1 4 2 2 8 8 196 d EILE 7 EIE OB cL CVascutekfE A T ISO 7198 air arae PU ECC mew E A e d 4 2 2 8 2 BA da Edu LLCOSSEERBATECLOVVC 4 2 1 6 7 2 a
37. 4 2 2 1 1 4 2 2 1 1 4 2 2 1 1 4 2 2 1 1 STED 4 2 2 1 200 3 4 4 2 1 6 ERR EAE c
38. 0 Suo ZOOR S23 REO S31 72V m 189 iod HE s ii A BA E E 30mm 40mm a Hv ISO 7198 5 3 N N 5 2 16kPa 1 E E 494 777 mL min cm mlL min cm 7198 5 2 Pa
39. 1 1 arvik 2000 203 3 TERUR Novacor LVAS HeartMate VE DeBakey VAD Jarvik 2000 5 4 IM TPRIHL CV Novacor LVAS HeartMate VE DeBakey VAD Jarvik 2000
40. 20300BZY00330000 20900BZY00255000 210
41. 3 3 3 3 1 2 5 8 0L 4 42 TOOhPa 7 1500hPa a l l l L l l l l l l l l r l l l l l 6 0 L min 1200 2400rpm 20rpm 3mPa s 6L min 80mmHg 37 Het 180
42. Hearts Management Issues United States Patent 4994078 INTRAVENTRICULAR ARTIFICIAL HEARTS AND METHODS OF THEIR SURGICAL IMPLANTATION AND USE THORATEC CORPORATION HeartMate II LVAS OPERATING MANUAL July 2006 United States Patent 5588812 IMPLANTABLE ELECTRIC AXIAL FLOW BLOOD PUMP Victor L Poirier and O Howard Frazier Portable Electric System for Long Term Use T Akutsu et al Ed Artificial Heart 4 Heart Replacement Springer Verlag Tokyo pp 103 114 1993 THORATEC CORPORATION HeartMate SNAP VE LVAS OPERATING MANUAL Eev A 03 07 01 MicroMed Technology Inc DIRECTIONS FOR USE The DeBakey VAD Child For Humanitarian Use in Pediatrics Rev A United States Patent 5527159 ROTARY BLOOD PUMP Roland Hetzer et al European Journal of Cardio thoracic Surgery 25 964 970 2004 First experiences with a novel magnetically suspended axial flow left ventricular assist device Berlin Herat AG INCOR Implantable Ventricular Assist Device Instructions for Clinical Use Version 3 5 United States Patent 6368075 B1 PUMP WITH A MAGNETICALLY SUPPORTED ROTOR 206 3 5 1 3 5 1 1 HaartMate VE Novacor LVAS 30 5090 DeBakey VAD Jarvik 2000
43. L A m3 b 4 2 2 1 2 4 2 2 1 3 4 2 2 2 4 c 1 3 5 3 5 1 5 HA R 195 4 2 2 3 4 2 2 4 4 4 2 2 5 3 e 3 1 4 1 3 5 Ager qure HX 0 D feo S7 o7 p JERKER E D Cs D LIF
44. ip 1 184 3 3 2 in vivo IISO 14708 1 17 2 500 25W m 1 IISO 14708 1 22 1 8O W sk 80 Confidence level 38189 4 2 7 ERT TI B fii 5 EE eoi ess 4 2 3 d f E BE f VERSES 1 mPa ud mPa s ms 2 5 L min 812 4 2 1 a 7 8 L min 4 2 2 a 185 186 in vitro
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