アクセントDR ACC - 医薬品医療機器総合機構
Contents
1. PSA Pacing System Analyzer PSA2. gt 1 2 3
3. 1 A NN OM CA 6
4. a EN 2
5. 10 6 7 8 9 5 8 11
6. gt 77 3 2 600 17 6 lt gt C 50C lt gt 1 2 2 5V 300Q 100 10 8 60min 2 5V 500Q 0 0 4ms 10 ERI 22 PP 2 5V 500Q Passive SV EGM On 100 0 8 SV s 100
7. PVARP rw MRD
8. PSA PSA 3 5 6
9. 1 MRI Off A 2 3 7 8
10. EE 8 1 NN EAS 2 E 3
11. 10 PHS X 1 15cm 4 2 1 1 3 15cm Ch OFF OFE OFF
12. gt gt 1 1
13. VVI 0 17 IC 10 RR os 2 6 Se Q1 RN AME 12cm
14. X DA D SA DA XX X DSA X X
15. 9 AMS Off DDL DDIR VVL VVIR 20 110 200 10 22 30025 min 21 AMS 40 170 min 22 AF Off On 3 23 0 90 150 5 160 180 10 min i 24 3 40 5 25 AV 23 30 200 10 225 300 25 26 AV 25 30 200 10 22S 325 25 ms 27 AV Off Low Medium High 28 AV 25 50 60 120 10 ms od 29 AV O 10 120 10 ms VIP 30 Off On 31 VIP 50 150 25 160 200 10 ms ww a 30 32 VIP 1 3 5 10 30 33 VIP 1 3 1 34 35 0 25 4 0 0 25 4 5 7 5 0 5
16. ERI ECG EE S CMOS
17. i 4 SR RE el 3 gt Shi a 2 NR RE EE 0 3 Off CMOS 4 PMT Pacemaker 2 E Mediated Tachycardia
18. 1 2 TENS 1 TENS AED
19. 4 5 6 7 gt gt 1
20. OFF X xX XxX X C MOS X DA DSA a
21. 2 _ 2 3 6 8 4
22. 2 3 gt E
23. 14 5 1 00 TR OO ET NE MNO 3 4 3 ERI Elective Replacement Indicator 2 6V BRI 8 BRI 1
24. 2 0
25. E 1 1 EK 1 1 2 3 4 EE PSA X
26. 18 B 12 lil 2 1 2 AA 2 6 3 1
27. 21 22 23 24 25 26 27 EMI 28 4 AV 29 AV V gt aL 8
28. 12 13 14 15 16 1 20 ERI 210min
29. ACap 30 VVI VVI 1 31 gt 1
30. TENS lt gt gt 1 2 ERI 3
31. 3 ERI TENS 2 5 CT X X CT CT X
32. Qn 125 157 190 220 250 2 30 60 95 125 160 190 220 ms Decay Delay 3 40 eo os 125 160 190 220 ms Decay Delay Threshold Start 30 625 75 100 3 Threshold Start 02 3 000 1 mV 6 30 60 95 125 ie0 190 220 ms Decay Delay 7 0 30 60 95 125 160 190 220 ms Decay Delay 8 Threshold Start 30 62 5 75 100 gg Cl eine 0 2 3 0 0 1 mV 20 3 Of AAI R AAT R AOO R 1 VVIR VVT R VDD R VOO R DDD R DDIR DVIR DOOR 2 30 130 140 170 10 min 3 AV 25 30 200 10 225 325 25 ms 4 Av 25 30 200 10 225 30025 5 125 160 400 30 440 470 500 ms 6 PVARP 125 500 25 ms 7 PV
33. 4 ERI 0 22cm Battery Test 8S 0min AF AV 70ms NIPS 2 5 ERI EOL 3 ERI
34. 2 PSA 1 0 2
35. 4 X X SJM HI 5 1 22000Bzxoo140000 REF 22100BZX00367000 22000BZX00141000 RE 22100BZX00373000 1 2 St Jude Medical 2 22200BZX00147000 39 IS 1
36. 7 1 2 2 10 1 3 1 3 5 10 4 30 130 140 170 10 5 AAL DDL VDD DDD VVL VDD DDL DVI DDD 6 AV 23 30 200 10 225 300 25 350 ms 7 AV 25 30 200 10 22 323 25 ms 8 0 1 0 0 1 0 75 2 0 0 25 2 5 4 0 0 5 5 0 9 mV 0 51 0 0 25 1 5 0 0 6 0 10 0 1 0 12 5 RA _ 10 11 190 400 30 440 470 ms 12 125 160 400 30 440 470 500 ms 13 PVARP 125 500 25 ms 8 NIPS 1 2 3 S1
37. RFID Im 7 lt 2 X X X 8 X X xX 9
38. RFID CR RPI 2 4 6 1 REID 2 RFID 3 X RFID 22cm 1 X CT X CT X X 5 3 RFID 920MHz
39. High Low Off PVC 2 5 1 PVC High Low Off 1 8 PMT High Low Off 9 High Low Off 10 High Low Off 4 11 High Low Off 4 8 10 1 Off 6 A EN 45502 2 1 2003 6 1 16 2 17 19 1 19 4 20 2 21 2 23 2 23 7 25 1 26 2 27 2 ISO 10993 1 2003
40. 2 CD CRT D YE PU 1 ICD CRT D o MR gt
41. 2 i AC ERD 3 EP 1 Q EP
42. S10 gt 105 7115 03 6255 6372 FAX 03 6255 6373 263 2009 AF CRM 2 15 8 8 2 03 6255 6370 1 2 3 CRMD St Jude Medical CRMD PR LLC St Jude Medical Puerto Rico LLC M Sdn Bhd St Jude Medical Operations M Sdn Bhd
43. VVIR VVTO NS DR ACC PM2112 7 DVIR 442 2 Aial Standsil 3 x x 46X52X6mm 8 19 a 10 5mL 5 IS 1 9 AF 10 VDD R
44. BE gt 1 m RU ICD CRT D m TE NAL 2 2 MR I
45. 6 FEGM On BRI 3 7 BOL ERI 100 85 0min ERI EOL 85 0 80 7min 8 EOL 2 5V EOL 16 9 VVI
46. Off VOO DOO 56 Off On 1 Off On Off 0 1 0 5 0 1 0 75 2 0 0 25 2 2 5 4 0 0 5 5 0 mV OQn Auto 3 0 2 1 0 0 1 mV 4 PVAB 60 200 10 225 250 ms 5 93 157 32 190 400 30 440 470 30 6 Off On Off Se 0 5 5 0 0 3 6 0 10 0 1 0 12 5 7 On mY Auto ON 3 1 8 9 0 2 2 0 0 1 mV 0 12 52 4 ms Off 1
47. 2 1 2 2 3 13 4
48. 2 251 4 sis1 100 800 10 ms 50 100 1 S1S2 5 S2S3 100 800 10 Off ms S3S4 6 0 25 3 75 0 25 4 0 7 3 0 5 V 7 8 0 05 0 1 1 5 0 1 ms 9 30 95 3 Off min 10 1 5 1 9 EGM 1 1 2 3 1 14 2 EGM 2 8 3 5 EGM 20 30 1 5 1 i 4 2 10 14 20 60 10 AMS AT AF High Low Off AMS 5 Ny 125 300 25 min 2 5 1 10 20 125 300 25 min 6 2 5 1 10 20
49. 4 PARA 35 H 16cm AH
50. Off AAI R AAT R AOO R VVI VDD R VOO DDD R DDIR DVI R DOO R Off On Off Passive On 80 150 160 180 10 min Auto 0 5 Auto 0 0 Auto 1 0 Auto 1 5 1 7 0 5 Very Fast Fast Medium Slow Auto 0 5 Auto 2 0 Fast Medium Slow Very Slow Auto 1 Auto 0 Auto 1 AutoG2 Auto 3 16 1 30 130 140 170 10 mn Of 30 150 min kN 90 130 5 140 180 10 min 90 1800 min Of 30 150 5 min off 0 10 20 min 30 80 120 10 1 101 Fast Medium Slow Very Slow Off 1 5 10 15 30 1 16 1
51. 7 IS 1 3 1 2 3 4 5 6 7 8 9 10 1 12 3 8
52. ERI 1 ERI 2 1 1 lt gt S1 2011 2010 2 203 2004 S3 18 2003 S4 237 2007 SS S6 224 2006 S7 190 2003 SS 301 2013 S9 s 221 2006
53. V 4 0 05 0 1 1 5 0 1 ms 5 AV 25 30 200 10 225 300 25 350 ms 6 AV 25 30 200 10 225 325 25 ms 7 8 2 101 9 AAL AOO DDL DOO DVL DDD 10 VVI VOO VDD DDL DVI DOO DDD 11 190 400 30 440 470 ms 12 125 160 400 30 440 470 500 ms 13 30725 100770 1207100 ms AV 14 PVARP 125 500 25 ms 15 0 05 0 1 1 5 0 1 ms 16 0 25 3 75 0 25 4 0 7 5 0 5 V 17 18 ns 19
54. 11 12 30 2 50020 3000 Oo 100 500 50 14 15 730 2 50020 3000 Oo 100 500 0 16 ERI On 17 A on _ 18 VVI On 1 AT AF Off On 2 AT AF Off On 3 AT AF Off On 4 ERI Off On 5 2 og 5 6 RR ES Off On 7 2 Off On 8 VVI On 9 2 162 10 1 16 1 11 10 22 12 2 13 16 RS ICO oz 2 30 130 140 170 10 min 3 0 25 4 0 0 25 4 5 7 3 0 5
55. V 36 0 05 0 1 1 5 0 1 ms 37 ACap Off On 38 8 24 Ro 39 40 41 0 25 4 0 0 25 4 5 7 5 0 5 V 42 0 05 0 1 1 5 0 1 ms 43 NE ofp on NS i _ 44 45 50 25 100 70 1207100 ms AV 46 8 24 47 125 160 400 30 440 470 500 ms 48 PVARP 125 500 25 ms 6 _ 49 PVARP V Ref Off Low Medium High 50 PVARP V Ref 125 475 25 ms 51 190 400 30 440 470 ms 52 PVC Of PVARP 53 PMT Of PVARP Passive 34 PMT 90 180 min 59
56. 10min On ACap ON On AF
57. 2 DDD R 1 DDDR PMMA AMS AF 2 6 gt
58. 5 CMOS X CT X 5 X 5 lt X RR RE DY X
59. AB 60 200 10 225 250 ms 8 0 25 4 0 0 23 4 5 7 5 0 5 V 9 0 05 0 1 1 5 0 1 ms 10 0 25 4 0 0 25 4 5 7 5 0 5 V 11 0 05 0 1 1 5 0 1 ms AT AF Off On ATAF 30 AT AF 3 6 9 12 24 36 48 3 AYAF M 4 AT AF Off On 5 ATAF 30 AT AF 3 6 9 12 24 6 AT AF Off On AT AF 7 69 12 F s AYAF 60 15010 175 200 mn 3 8 1 Cap 9 ATAF 1 10 PO On
60. LVV034004140131 LVV 034 2014 1 31 4 22200BZX00933000 2013 3 27 3 7 12913000 DR ACC gt ee 11 AOO R VOO R DOO R 1 3 4 a IM 1
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