（参考資料その3）（PDF:565KB）
Contents
1. 52. 10mL 10mL
3. _25 58
4. MRD CMOS 1 DR 5820 DR S826 XL DR 442 2 5820 5826 x x 43X44X6mm 44X52x6mm 18g 23 5g
5. 68 0min 9 EOL 2 0V EOL 2 10 VVI 2 4 VVI 2
6. 1 PSA 10 11 1 2 P 3 NN 4 CS 1 5 0
7. DDI VVI R VVT R VOO R DVI R Aial Standstill OE 22 1
8. 1 1 6 2 7 8 PSA Pacing System Analyzer 1 PSA PSA X 9
9. EAS 1420ASASP CGN TH IH
10. 1 CF AC NE ERD 3 1 EP
11. 1 9 3 PSA 10 11
12. 3 4 ERI Elective Replacement Indicator 2 5V ERI ERI ERI 100ms 86 3min AF
13. ir 2 1CD CRT_ D i 4 16cm 2 Off lt Co lt 2
14. 11 12 0 2 Ai 3 3 CMOS 6 1
15. gt 1 HI 2 3 4 E 5 OV EO Ni 6
16. PVARP gt AAIR AAT R AOO R DOO R AOO R VOO R ODO OAO OVO PMT Pacemaker Mediated Tachycardia DDD R
17. ERI
18. TENS TENS TENS 2
19. ERI 190min 10min On ACap ON ACap i On AF
20. 2 Ee X Xx CT 20 CT CMOS 3 X 5 X CT 2 res X 5
21. ERI X 5 ECG 6 8 22 58 gt gt 1 DA 3 DSA
22. X ar 3 lt DA DSA X OFF ed te 3 X X XX X C MOS ry DSA X
23. 4 PSA 12 13 14 15 5 16 6 17 7
24. AF VDD R E 2 QCD gt 1 CRT_ D ICD CRT D
25. 1 3 8 ICO
26. 1 REID REID RFID 22cm RFID 9S0MHz RFID Im 2 PHS 1 22cm 2
27. 2 2 6 7 8
28. 2 PVARP VREF 120 330 10 ms 3 Ra on or gt BR 4 6 5 8 24 3 1 6 0 50725 100770 120 100 ms 1 SR 7 ACap On Off GS AOOR AAIR AAT R OAO VOOR 8 1 VVIR VVT R VDD R OVO DOO R DVI R DDI R DDD R ODO 9 8 24 2 30 40 130 140 170 10 min 3 20 Off 90
29. ME TN a 0 9 y rm 0 E o o 1 RS 2 i
30. 13 CN NR
31. I2cm
32. 20 12 10 3 2 2 240 0025 179 045 710 1571 FAX 045 710 1584 26 58 OD 7 21 12 24 22 1 8 UD 1 IV 2 MD 90890 MD 90891 No No 80717 189 G80812 103 80804 76 G80911 198 80805 112 G81014 94 G80908 166 G81015 95 G80923 268 G81025 73 G80924 126 G81030 121 G81026 165 G81108 24 G81027 31 G81109 63 G81111 197 G81110 105 G81123 32 G81122 103 G81124 163 G81208 217 G81201
33. CO 6 21 12 21 7 vo 8 9 240 0025 179 045 710 1571 FAX 045 710 1584 28 58
34. 10 LV 19 2010 8 30 3 22100BZX00234000 2009 9 24 2 7 12913000 DR 11 AOO R VOO R DOO R 0 gt Ll EP 10 3 4
35. gt E E 1 3 gt
36. DA X gt 1 AED
37. AMS 8 2 9 AF AF On AT AF a PS ATAF 0 AT AF AT AF 1 2 3 3 a a H
38. X 2
39. Wn Off AV 4 PVARP VREF 200ms 2 ERI EOL 3 ERI EGM On ERI BOL ERI NIPS EP EGM 98 6min 86 3min ERI EOL 86 3mn
40. EN 45502 2 1 2003 3 6 1 16 2 19 1 19 2 19 3 19 4 20 2 21 2 23 2 23 7 25 1 26 2 27 1 3 2 E
41. 1 1 2 3 2 3 7 8 9 0 2 3 11 12 13 14 5 2 4 4 gt E E i
42. A EMT 27 28 AV VVI VVI 1 AV o o
43. 0 2 ERR dy 1 6 1 MRI gt 3 OF OfE 2 AM 4 2 2 lt gt A ER Ei
44. 1 SAE RN CN A CC REID TT 3 X 5 8 16 2
45. 221 2006 S8 X 0924 5 lt gt 2009 105 7115 3 2 03 6255 6372 FAX 03 625S5 6373 5 2 15 03 6255 6370 1 St Jude Medical CRMD 2 St Jude Medical AB 3 St Jude Medical Puerto Rico LLC AE CRM CRMD AB LLC 8 8 24 58 OD 71 20 12 10
46. 18 19 20 21 22 3 IS 1 23 3 1 24 2 25 3 26 4 8 20 58 12 Cs
47. C 7 Ah 8 VO 9 A 0 11 O c Q 2 _ EN 45502 2 1 2003 EN 45502 2 1 2003 Active implantable medical devices Particular requirements for active implantable medical devices intended to teat bradyarrhythmia cardiac pacemakers
48. ID 1 1V 2 MD 90890 70803 241 70905 298 71001 310 71204 200 80108 280 80202 305 80203 93 80305 14 80319 41 80330 68 80406 45 80407 91 80409 33 80410 31 80411 27 80425 225 80426 85 80517 110 80528 120 80605 212 80606 62 80619 116 80620 151 80708 295 3453 19 8 23 20 8 20 3 179 1 14B1X00016 179 14BZ005022 4
49. Eg GHC E 7 8 5 6 es gt lnk
50. 90 130 160180 10 3 S S 4 VDD R 36 On Off Passive 2 SM 37 80 150 160 180 10 min 1 Auto 0 5 Auto 0 0 Auto 0 5 38 Auto 1 0 Auto 1 5 Auto 2 0 1 7 0 5 1 OfE 30 130 140 150 min eS Auo D Autod0O AuoGD Auto 2 Auto 3 1 16 1 J P i 5 40 Very Fast Fast Medium Slow M 3 1 16 1 41 Fast Medium Slow Very Slow SS IM 1 4 20 ea 5min 80 120 10 2
51. 161 65 V 0 13 95 0 13 0 0 SD V 0 06 0 21 2 ACap 41 V 0 13 95 0 13 0 0 SD V 0 06 0 10 1 161 3 98 1 95 95 2 2 64 100 95 94 3 100 gt 1 0C 30C lt
52. 0 5 0 0 0 1 i 8 0 0 0 0 9 0SNi 4 ba SE
53. Et 2 6 7 P R P R 19 58 3 8 2 1 VDD R P R 1 18 ON OFF 19 EP NIPS 9 100 800 10 ms 2 S1 1 25 1 3 S1 S2 S3 S4 ss Off 100 800 10 ms Uy voo OL30 40 95 min NIPS
54. 60min 60min 5 3 AAI R AAT R 5 4 io 4 AMS NN 5 VDD R 6 Fast Medium Slow Very Slow 7 Off 30 130 5 140 150 min 8 AV Or Low Medium High 2 8 18 58 a 2 EGM 3 EGM YE 1 2 4 8 12 A BGM A V A V EGM 5 mv
55. RAO 2006 2 11 15 1 j 1 77 3 2 600 17 6
56. 130 5 140 180Q10 min 21 op a 25 30 200 10 225 300 25 S ACT 3 3 VIP Oft 50 15025 160 200 10 2 s 5 AV 25 30 200 10 225 325 25 ms ad uu a 6 125 500 25 5 23 VIP 30 1 3 5 10 30 7 PVARP 125 500 25 ms 2 vp 2 8 0 0 4 0 0 25 4 5 7 5 0 5 V ev 9 0 05 0 1 1 5 0 1 8 25 MR 0 Off 10 11010 ms 0 0 5 5 0 0 5 6 10 1 0 12 5 mV oft DDDR to DDIR DDD te DDL ER So VDDRtoVVIR VDDtoVVLDDDR 1 2 26 AMS to DDL DDD to DDIR VDDR to VVL 8 VDD to VVIR 2 NS 27 0 130 160 20010 1 min ay 225 300 25 3 0 0 4 0 0 25 4 5 7 5 0 5 Vv 28 AMS
57. M EGM 1 A V _ BGM A V A V EGM js0 7 5 3 0 15 mV On Of amp AT AF AMS Off 3 of 125 300 25 min 2 3 4 5 10 15 20 a Of 125 300 25 min 2 3 4 5 10 15 20 PVC On Off 8 PVC 2 3 4 5 PMT On Off on Off 5 a 9 MS37
58. 1 5 EPLab Off 2 5 1 A Ma 2 NIPS AV 3 S1 b S1 Off Battery Test 2 3 4 CV mA 5 6
59. 198 J81217 62 G90119 98 J90108 40 J90120 97 J90119 85 G90126 197 G90119 78 J90217 97 690126 188 J90224 93 J90210 183 690307 198 G90219 10 J90519 108 G90220 187 G90529 88 J90304 95 90716G 104 G90306 97 90717G 69 J90310 197 90808G 21 G90320 198 90810G 120 J90407 98 90905G 76 J90414 85 TOTAL 3 089 G90425 198 J90512 198 J90526 198 G90528 98 J90602 161 J90616 198 G90620 53 0 1 G90621 193 J90623 98 90714G 160 90715G 36 TOTAL 4 390 7 479 20 8 20 21 10 30 3 179 1 14B1X00016 27 58 179 14BZ005022 5 4
60. FC ed X CT 2 0 2 3 5 1 2 3 4 5 6 7 8 21 58 X CT X X 5 X X X X X RRB 0
61. gt 1 23 58 2 5820 5826 DR XL DR 2 5V 500Q 60min 1 0V 500Q 0 72 13 0 DDD Mode Auto Capture On 100 Pacing Sensor 2 5V 500Q ve 2 5V 500Q PO 6 5 11 7 Auto Capture Off 1 1 gt Si 2006 2005 2 173 2002 3 185 2003 S4 237 2007 SS 224 2006 S6 190 2003 S7
62. 0 35 5 P 4 0 05 0 1 1 5 0 1 ms PC FE TE 29 AF On Off 3 125 15 175 20 25 30 35 40 50 mV AF 30 80 150 160 180 10 min _ 6 a 31 15 40 7 ga a g 60 70 80 85 95 100 110 115 125 130 1 32 Off On PVAB 140 150 155 165 170 180 185 195 200 9 ES 3 Off PVARP on PVC APace on _ 9 Auto 12 12 52 4 ms 33 PVC PVC 1 31min 34 PMT Off 10 Beats gt PMT Auto Detect 2 s 0 9 i 325ms 35 PMT
63. 2cm A A NG
64. 8 5mL 11mL IS 1 1S 1 3 2mm 3 X 1 5820 X 2 VW gt SER i A Sad 0 60 100 20 125 350 25 ms 1 PVKSRPRET Off Low Medium High
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