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医療機器の安全管理
Contents
1. 1 2 MNO 1 gt si
2. leart ec
3. FNARRIDS CU 6 KO 9 W2 0 SR 5 ME
4. PSV PEEP EN Pl 2 ON SIMV Synchronized Intermittent Mandatory Ventilation SIMV ASSIST IMV PSV
5. 17 2005 4 1 2 SR lt
6. IT
7. INo 21 LAN 8 Ra 8 gt
8. Human factor Environmental factor A Ym Management factor
9. q CRM Crew Resource Management 14 2002 10 INo 21 15 2003 7 30 eR
10. 1 lt 1 gt 2 3 10 15 1 60 8 50 70 40 60 No 21 loart er
11. SO 29 5 PHS GDA 2 2 7800NGISN 2 N TCON DN DC A NR 220 2 pe 0 MNO 0 2 I0E 5 62
12. 11 1999 9 TAN Tapanese Article Number EAN European Article Number UPC Universal Products Code UCC BEAN 128 17 2005 6
13. 22ZSSSA2 1E INo 21 leart ec 1 ME ME MM 00 U0 nh 2 2 KICM PGI RU 0 am DI2I2 SNU UIe 5
14. Ac accountability 5 4 5
15. 202GIMGICOTBEE 240 GE 6 loart er N 1 082 N 999 N 916 0 20 40 60 80 100 lt 5 gt 4 415 34 2 6
16. leart ec O 2 2
17. 7 AED loart ec AED AED FR2 2 150
18. leart ec
19. 4 720 0031 3 4 8 TEL 084 923 3073 10 000 770 000 i 0 RG 0 ee 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 i Heart Net No 1 17 6 4 CAVI ABI 2 gt 113 0033
20. 5 4 100 6 1 AED 40 5 AED 30 20 10 0 1 2 3 4 5 6 7 8 9 3 2AED Automated External Defibrillator FR 2 AED 21400BZY00185000 Nw FUIKUJDA 3 39 4 DENSHI http www fukuda co
21. 75 7 1 481 45 2 5 228 21 4 279 26 2 IGK ES 1 3 2 3 lt al 2 SUUO 02 SNS Eo PO 4 lt 6 gt _79 z 1 26 2 5 228 lt 7 5
22. 5 11 Me WE 0 4 2 NT rp
23. http www mhlw qgo jp topics bukyoku isei anzen 2 kaiser 2 2003 0515014 3 2003 15 4 2001 1340 158 http Wwww t mia org 1340 pdf 5 1999 5 2 6 2004 Vol 74 No 11 pp 681 687 4
24. 3 2 2 7B5 6 2 2 4 5 4 o ME 6 2
25. SC OCONEE UN NR EC No21 boart er 430 lt 460MHz TCON 1 2GHz LAN 2 4GHz Nh PHS TCONTM PHS 1 gt
26. 16 ICU NIBP DS 680 640 620 FUKUDA 3 39 4 http www fukuda co jp 1600BZZ00078000 loart ec
27. 2 gt NAO AA 2 iAS 6
28. IT ID MU CAN CR 092 028 20220 7
29. ON OFF 6 PCV Pressure Controlled Ventilation PCV 80 2000 ARDS Net 1 1 ARDS PCV 22 00 0 0 2 2 0 2 INo 21 PSV SIMV 1
30. ME ME MARIS ME MARIS 3 ME 3 MARIS MARIS ME amp GE ye 2 seans2rs MARIS MARIS ME ME 02 20 20 2 Be 23 UE ME
31. ME 20 ME leart ec MARIS ME ME ME
32. 15 2003 12 300 935 ME SPD 5 leart ec 366 39 1 1 302 288 78 7 334 91 3 ME 244 66 6 188 51 4 248 67 8 KID G ME M E 680 55 5 ME
33. 348 28 4 ME OD 1 3 02 3 4 ME 6 2 1 5 3 ME
34. N 1 144 N 1 351 N 1 167 N 1 161 0 20 40 60 80 100 9 ME lt 3 N 1 224 N 1 787 N 1 210 N 1 244 0 20 40 60 80 100 94 ME 4 INo 21 lt AI CDO 3 15 2003 1 14
35. ICU 2 GEe MNOUASN UN AWD22 20
36. 6 CN EN CO CN EAC EOE IS ME ME MARIS ME NGSIUIHNN SA 5 ME ME INo 21 100 1 10
37. 1 3 ME 4 3 3 7 7 2 4 N 1 017 N 1 155 N 1 078 N 1 109 0 20 40 60 80 100 ME 1 gt lk N 1 214 N 1 870 N 1 242
38. 0 2 2m 2 0 DC GR 2 SMElaNM0GI Se 0 NO
39. PDA Personal Digital Assistance leart Ne EBM GUSS II SAUDO0 6 5 MP 6 2 Web NN IDII SIGI
40. 3 13 6 VaSerz VS 1000 TEL 03 5684 1285 21400BZZ00132000 http www me times co jp RL RL RL Re Re Re Re Re Re Re Re Re te K 24 FUKUDA 3 39 4 DENSHI http www fukuda co jp 262 50 IA2006EMIE No 056134
41. 82 20 5 2 9 OKUSA ISSO UE23 NN leart ec SD NR TR OD GS EBM IT ME 1 2002
42. PCV PCV 90 2 PRVC VSV 82Se20PA MUSIC 1 VSV
43. N 1 285 96 ME 2 gt leart ec 1 2 4 ME ME
44. 2 MANUIASIARMON Re ICU CCU 1930 1950 KS 1960 020 0 OILMNNN MOSleise End Expiratory Pressure 1981 PSV Pressure Support Ventilation
45. ME ME ME LT EEE i ME PT EE MARIS 3 6 MARIS ME 3 ME MARIS ME ME AG TUIU GO 2D 1 2 2 MARIS ME
46. ME 1 PDA 4 FUKUD DA 3 39 4 VV DENSHI http www fukuda co jp e e s Maintenance Activity Record Information Syslem loart ec ME 1
47. lt 2 22 AG So 0 NN ES CO 8 Me 2 PU CN OO0N 2 7A 1
48. jp 150J AHA Illa 9 1 2 3 4 1 1 2 1 Oculovestibular reflex caloric stimulation 1 gt
49. Rleart Nec ME MI 1 17 4 1 I OE 1 Un 3 4
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