医療機器安全管理指針第1版
Contents
1.2.
3.
4. pd pd bad pad ped ped avd ped pad peed Dad bd paod Pad briod
5. 29 Japan Association for Clinical Engineers CAC 1 5 No
6. 69 Japan Association for Clinical Engineers CAC
7. II EID INED INED INED 2 PO DHP 2
8. 4 ole F PV 2 3 5
9. 1 11 2 3 H 3
10. 2 l ml min ml min
11. 15 2 4 1 11 2 3
12. Japan Association for Clinical Engineers CAC 2
13. 6 We Japan Association for Clinical Engineers 13 1 2 2 2 OO 1 12 0000 0000 OO
14. 0 6 10 1 11 2 3
15. 92 25 5 24 183 gt 1 1
16. 2013 7 I 19 4 1
17. Japan Association for Clinical Engineers Ac 4 1
18. 6 3 14
19. 4 13 1 B 2 3 5 1 AC AC ee
20. PMDA Japan Association for Clinical Engineers Ac 3 19 4 5
21. 2 3
22. 2 1 1 2 1000 2 3 6 1
23. AC 0 START STOP START STOP 3 START STOP START STOP RESET AUTO PRIMINGC
24. AED 5 1 AED 9 gt Oo 6
25. Japan Association for Clinical Engineers Ac 5 1 K5 1
26. G6 7 G8
27. 97 3 a b c 4 Japan Association for Clinical Engineers CAC 2 1
28. 4 13 1 2 3 5
29. EE Japan Association for Clinical Engineers CAC No by ul ni CRT
30. by ul lt 64 ml h
31. 250rpm 50 K ie3 2 Diy 3
32. 3 2 O 1 1
33. 63 Japan Association for Clinical Engineers Ac 1 1 1
34. LED AC 3 0 0 1
35. 1 11 1 2 E
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37. E No ON LED
38. 1 a 15 30 b
39. a NaOCU b Co ow 40 e
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41. 1 1 AED AED AED AED
42. ON OFF 62 3
43. 1 11 2 3 MMP uy
44. 1 AED 2
45. 24 2 PCPS PCPS No by 939 il gt PCPS PCPS Ni
46. 13 1 2 3 OO O OOA Ne OOOOOOO OOAA OOO O OO OOOO 2 3 5 IOO No 197 O O DP OIO OG
47. LED SPO gt 2
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49. AED AED 3 3 3 2 AED 4 AED
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51. 4 5 6
52. 1 1 No 3 ON LED
53. OO 1 12 00 00 1 Up EE Japan Association for Clinical Engineers Vace 3 6 14 100z A 500zA a 500zA 1000A 0 1Q
54. 2 pone 1 2 5 3 5 6
55. 60 2 No
56. 0 220 01Mpa 200mL 1 DC2 8 3 0V a a Ed bea bol bea be bea be bea he buon bel a yy 3
57. 12 ug 3 6 14
58. 94 ch 2013 7 113 0033 3 4 3 884 4F 03 5805 2515 FAX 03 5805 2516 151 0051 5 29 7 1002
59. 4 17 4 1
60. 3 4 1
61. Japan Association for Clinical Engineers CAC 2 AED 1 Automated External Defibrillator AED AED AED AED
62. 23 23 202 23 E 1 1 201 203 194 E4 1 E 9 1 19 19 27 19 53 3 19
63. 1 1
64. EEE2E boid bad bad bad baad Dano bao lt EE Japan Association for Clinical Engineers CAC 6 2007 01 x 2007 01 x 2007 01 2007 01 2007 01 2007 01 2007 01 2007 01 2007 01 x 2007 01 x 2007 02 NIKKISO TORAY 6000 4000 O 6000 4000
65. UP DOWN 50cmHz0 50 LED
66. 1 1 1 63 2 1
67. AED 13 1 2 2 2 Japan Association for Clinical Engineers CAC O 1 12 AED 00 00 00 01 AED 3 6
68. 2 AED 3 AED 3 1
69. No ON by ul ni
70. 2 GJ 6 7 9 10 11 O1 0 WD OO
71. 15 2 6 2
72. Japan Association for Clinical Engineers CAC 1 7
73. 13 1 2 2 2 3 6 1 100zA 5004A 500wA 1000A 0 10 AC
74. ep 1 1 0 U 1 1 2
75. Lui m mm 10 1 3
76. 3 yi yy yy yy lil 1
77. 5 1 1 2 2
78. 1 AED AED 23 201 17 2 AED 3 3 4 AED
79. 3 6 15 CHG mylyn 3 PCPS
80. 22 67 245 4 1 lt ul Fi 19 3 30 0330010
81. m 2 1
82. 80 4
83. 1 1 NII Cg lt ee
84. a b 13 1 2 3
85. 9 40 1 Japan Association for Clinical Engineers Ac 2
86. AED O No AED OO OO OQ E
87. 2 3 4 5
88. E 100zA 500xA E 500zA 1000z A 0 10
89. i OT 2 1 2 Me g 3 i 4 ee 5 ee 13 1 2 2 2 2 1
90. No SW
91. 2 OO OOH OO OO OO OK NG OK NG mL hr mL hr OK NG OK NG mL hr mL hr OK NG OK NG mL hr mL hr OK NG OK NG mL hr mL hr Japan Association for Clinical Engineers CAC 3
92. IABP No l by ul a 2 IABP
93. O OOOOO 1 6 OOOOO 1 9 OOOOO 1 3 OOOOO 1000 8000 OOOOO A 3 4 B 1 10 OOOOO A 3 4 B 1 10 OOOOO 1 3 1 32 A 3 5 B 1 11 3 6 1 100A 500 A
94. ml h 2 9 lt OO DO DO OO DO DO 5 OK NG OK NG mL hr mL OK NG OK NG mL hr mL OK NG OK NG mL hr mL My OK NG OK NG mL hr mL 3 CA i ne
95. 1 6 10 1 11 2 3 1 2
96. F 2 2 1 by ul ni No gt y gt ELEIEES mylyn 2 2
97. 77 4 2 2 90 0328003 20 3 28 3 26 20 50 13 3 12 188
98. mm 1 6 1 2 1000 2 3 6 1 3 4
99. 13 1 2 2 2 3 6 1 E f 100A 500 A 500A 1000g A 0 1Q SS E 2 J
100. 1 2 A4 8 4 1 1 Q1 2 A4 3 1 1 1 1 2 2 3 13 4 4 5 15 6 16 7 17
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102. PCPS No LED PCPS
103. 1 3 1 1 12 00 00 3 1 EE Japan Association for Clinical Engineers CAC 0 2
104. 3 13 1 2 2 2 IABP O 1 12 000 000 OOO 000 000 NN 1 3 1 Sr 2 Japan Association for Clinical Engineers Vace IABP 3 6
105. PCPS No LED by ul mi 0 3000rpm AC
106. 15 9 12 AED 4 AED AED 2 3 3 AED AED
107. 15 3 26 5 1 2 3 AED Japan Association for Clinical Engineers Vac 1 ee
108. 4 5 6 6 1
109. IV IL 1
110. 1 1 1 1 1 2 a b c a b a b
111. AED OO OQ OO OO No 2 1 2
112. Edd dg a a da Rg Ed Re ET a 4 EMEAEEMEEME mlmyioyliylmy nu 3 my iylyly 2 bd bad bud bos 3 es bi 9 5 re et 0 4 1
113. OR 1 1 4 TN 2 3 5
114. 1 1 1 1 No
115. 1 2 25mL hr 25 2 5mL L 10 60kPa M 30 90kPa H 60 140kPa 1 mL 90 25mL hr Japan Association for Clinical Engineers CAC 3
116. FAX 5 5 1 0330001 AED 20 3
117. NN 1 1 1 Japan Association for Clinical Engineers CAC OOOO 1 OO OO 00 00 00 01 1 lt 1 2 OOOO 2 OO OO
118. 2 8 9 10 II Do 13 1 2 5 1 2 2 4 5 6 1 7
119. 2 4 No 3 1 FE No By
120. 2 M ly yy lyll2i 2 gt mylimyly 13 Japan Association for Clinical Engineers Ac 3 190 3 1 11 4
121. IABP No AC IABP by ul CT ENPIEyI 20 3 IABP No
122. 2 a 0 2 1 3 1
123. 1 1 1 2 No ON
124. 18 2 3 Ce 6
125. 18 23 205 15 3 9 Japan Association for Clinical
126. 4 1 93 Japan Association for Clinical Engineers CAC _ AED
127. 3P 42 2 30 1 2
128. 3 35 145 2 4 4 3 Japan Association for Clinical Engineers CAC 1 2
129. Japan Association for Clinical Engineers Ac RM 5 ee lt ae 77 3 2 3 eh
130. 1 0 3 1 0 1 7 0 02 E lt
131. A oo a PEEP CPAP 1 by 1 4 No
132. lt 86 2 19 4 0330001 0330018 E 3 30 23 205 6 10 23 50 1 11 0330010
133. Japan Association for Clinical Engineers ace 13 1 2 2 2 PCPS OO 1 12 000 000 1 3 1 PCPS 3 6 1 100zA DD 5004A 500zA 1000wA 0 1Q
134. NN gt i 9 4 9 a SY 1 2
135. py my oy Dd my mln 3 gt yy yy Dd ny 1 OO OO
136. A M1 M2 12 EE pug bd bd ba bad pnd bad bud bod pad pid panad EE2EME2P2 bad bad bd aned band bared pred paid band bad bad baad biod baood bad bod pod pated EEEEP2E BEP PP hbase hbase hhh 39 Japan Association for Clinical Engineers Ac 3 4 lt 13 1 3
137. SW AC 50 AC 100 AC 200 AC 360 50 100 200 360 AED
138. Automated External Defibrilators AED 15 11 AED AED AED AED AED AED
139. gt yy yp yy yy Dy yl yl yy yy yy yy ly gt yy yy yyln Dbl Dd Japan Association for Clinical Engineers CAC 2 3 2
140. L 0 2 3 1 27 8 9 10
141. LED 2
142. 1 OO 55 OO AA OO OO 3 Go 00 4 oo oo OO 5 oo oo 6 DO OO Se x x 43OO 8 OO 00 9 oO OO 10 OO Go O 11 OO GO OO 12 Oo Go 1 oooo PO OO ooroo oo oo gt DVD 13 OO OO OO OO OO 14 OO OO 2 koo oo oo oG DVD 15 OO 00 16 OO OO DVD 17 OO OO 4 a 18 OO OO DVD 19 OO OO v 20 OO OO
143. 4 5 Ver1 02 25 1
144. 4 O 1 12 0000 0000 COOOOCO 0000 0000 OOOOOO 1 3 1 44 5 3 6 1 a 100A 500 gz 500wA 10004A 0 19
145. OAXO TOOZ02O0100Z02O OOZOZAD OOZAOZAO TABP OO ZO0ZO100ZO0ZO OOZOZAO DOZAOZAOD OO ZO0ZO100Z0ZO OOZOZAO DOAOZAOD OO ZO0ZO100ZO0ZO OOZOZAO DOZAOZAO 3 OO Z0ZO100ZOZO OO0 0 0 00Z0 O 4 OO ZO0ZO100Z02O OOZOZAO 00Z0 O 4 OO ZO0ZO100ZO02O OOZOZAO DOZAOZAO OO O 0 OOZOZD 100 Z0ZO DOZAOZAOD 2 en 0 Japan Association for Clinical Engineers Ac 1 by Of DM RR
146. 3 2 1 11 2 3 1 1
147. 13 1 2 3 4 5 CU 68
148. 2 3 77 3 2 3
149. 3 20 5
150. 35 145 2 4 5 2
151. 28 1 2 No I 939 Mn 0 1 3 E No
152. 2 a CHsCOOH b 16 6C c a
153. 3 13 1 2 F i 2 2 Japan Association for Clinical Engineers Ac OO 1 12 0000 0000 OOOOO 0000 0000 OOOOO 1 3 1 1 1 a 1 a b c 3 a
154. No LED ON
155. 4 88 5 1 1 2 6 1 1 2 3 1
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157. ie3 3 IABP en ON ww 4 13 1
158. 14 159 71 1 8 24 19 E 3 30 14 108 3 31 82 5 E 2 Ne NN Ug Ne i Nn eo 6 1
159. X 1 1 No
160. 30 2 3 No ni 1 i PEEP ICPAP
161. 1 1
162. 1 6 1 1
163. 13 1 CD 2 0 3 6 1 2 2 1007A 500zA 500zA 1000wA 0 1Q v
164. li 26 4 13 1 2 3 5 Ni 1 AC 2 SS 3 i 6
165. FE s ZZ UL 2 No 5 6 3 3 6
166. No AC 16 3 No
167. QH I 939 Mn NO A 2 NO 1 1 No gt E HH
168. 4 22 11 16 8 Japan Association for Clinical Engineers CAC IT 1 19 4 1 0330010 19 3 30 18 6 21 18 84 23 205 3
169. ee te oi 1 1 NN b c d
170. 2 3 2 1 2 3 4 5 3 1 2
171. 9 1 1 1
172. 3 No 2 3
173. 1 13 1 2 2 2 OO 1 12 0000 0000 OOOOO
174. 19 Japan Association for Clinical Engineers CAC 2 TABT 1 Intra aortic Baloon Panping IIABP 1 1 1 1 1 1 IABP 1 2
175. b 6 a b c 1 a 38 3 3 6 1 100zA 500 z A ROOT 1000 7 A 0 1Q
176. 84 2 1 11 2 3
177. 3 1 66 0000 0000 OOOOO 0000 0000 OOOOOO 0000 0000 OOOOOO 2 1 3 1 E
178. 1 83 Japan Association for Clinical Engineers Ac 3 4 CO 1 1 1 11 1 3 2 2
179. 2012 7 1 1
180. OOOOO 1 6 OOOOO 1 9 OOOOO 1 3 OOOOO 1000 8000 3 4 OOOOO 10 3 4 OOOOO 1 10 3 5 OOOOO 2 2 JIS 5 11 EE
181. 2013 7 1 CE Jact 1 I 1 ee 5 2 3 RC 9 3 1 3 2 O ee 15 9 28 35 AED Oe 49 60 64 69 73 4 76 7
182. 0330018 19 3 30 3 248 13 3 27 4 CDC Recommendations for Preventing Noso comial Pneumonia 2003 5 CDC 2004 6 2012 7 34 1
183. 9 2
184. 39 E E 3 26 19 108 19 70 10 5 92 19 93 158
185. 05 10 5 50 LED AC100V 3 el
186. 2 2 AED 2 3
187. 6 5 Japan Association for Clinical Engineers Ac 2 3 10 P61 64 2006 1
188. 1 2 13 1 2 2 2 2 1
189. 1 3 1 Japan Association for Clinical Engineers Ac 3 6 1 F 100xA 500 A E 500gA 1000z A 0 1Q CRT
190. 13O 140O mEq L 3 O 140 mEq L 1 2 3 4 Na K 36
191. 13 1 3 A B 2 BE 5 Japan Association for Clinical Engineers CAC 0701001 16 7 1 AED
192. 2 Japan Association for Clinical Engineers CAC DVD
193. 16 8 1 0801001 19 3 30 0330001 0330018 23 50 33 162 6 ul Ci 1970 6
194. 2 3 4 ans 5 0 1
195. PCPS 1 percutaneous cardiopulmonary support PCPS 1 1 1 1 PCPS 1 2
196. 1 Assy 3000 4000 3 6 6 46 8000 3 2 4 5 6
197. Japan Association for Clinical Engineers CAC 2 No R by ul a NN 3 No
198. No LED Py 1 2 No
199. E 00xA 500zA E 500zA 1000zA 0 1Q
200. 5 DVD OOOOE O OO Sa OOOO OO OOOO E OO 3 3 1 1
201. 8 18 9 19 10 1 1 2 3
202. QH 0 31 Japan Association for Clinical Engineers Ac 2 No L l
203. i eo 77 4 2 2 3 4 5 6 7 8 6 3 1 2 1 1 2 oita ee 3 0
204. E 500zA 1000z A 0 10 Mode PROX 1 1 2 2 8 20 19 21 713 30 2 32 17 60 1 2 36 44 1 2 56 64 72 88 1 LT 1 0 30 250 350 50 450 550 SPONT V1 70 650 750 PEEP 9 21 24 A 37 43 6 57 63 9 77 83 1 97 NORMAL TRANSPORT TIME LIMITED DEMAND FLOW LED ET es
205. mEq L mS cm L hr L mL hr mL TMP mmHg mmHg L hr L EID DI 43 Japan Association for Clinical Engineers Ac 3 3 ot 3 6
206. 2 3 5 1 AC 2 ee 3 A nil oo lt ll 22 6 23 Japan Association for Clinical Engineers CAC O 3
207. 11 2 3 2 1
208. 12000 9000 7000 2 9000 O 12000 O 3000 12000 16000 10000 3 6000 Assy 3 9000 6000 12000 O 6000 8000 300000 2 Em un 0O tty 4 5 rn ml ao ml TL Pr 4 eirrlrrlrclrclrrlrrlr CC Cc Zn 3500
209. 2 1 1 1 2 89 Japan Association for Clinical Eng
210. 1 1 1 2 No LED SPO 49
211. 0 1 11 1 11 1 11 1 1 ee 1
212. 1 1 12 00 02 OOO 00 03 1 1
213. 1 P13 P33 39 2006 11 1 65 67 2004 P68 72 2006 P73 77 2006 ME 3 2011 48 1 1
214. 3 1 2 3 33 Japan Association for Clinical Engineers Ac 5 1 2 2011 12 2 033001
215. 6 PDR OR ROOD RN 82 Ver1 02 19 4 1 6 4 1 EX 2 3
216. Engineers Ac 3 0705 5 24 7 5 24 25 1 23 205 23 326 23 50 25 1 13 6 14 637 638 24 25 1 24 25 1
217. OCOO 0000 0000 OOOOOO 0000 0000 OOOOOO 3 1 1 3 6 1 E 100A w E 500zA Q000zA 0 10 F
218. base Bil 3 AED gt 4
219. gt 3
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