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1
2
3 i -
4 /ICD /ICD VDD Inhibit Asynchronous ii -
5 iii -
6 iv -
7 /ICD /ICD VDD v -
8 vi -
9 /ICD /ICD VDD vii -
10 /ICD /ICD VDD viii -
11 ix -
12 Electronic Article Surveillance - 1 -
13 SSI DDD VDD VDD ICD-S ICD-D - 2 -
14 AAI P VVI QRS SSI AAIVVI DDD AAIVVIAV VDD P ICD-S VFVT SSI ICD-D VFVT DDD - 3 -
15 MHz khz - 4 -
16 MHz MHz GHzkHz HzkHz khzkhz khz ONOFF - 5 -
17 - 6 -
18 Medtronic Irnich cm 2 cm 2 cm 2 cm 2-7 -
19 Irnich cm mm
20 Ω - 9 -
21 m cm mm
22 20cm 2.7m2.5m
23 AAI(R)VVI(R) ppm AAI(R)VVI(R) DDD ppm VDD VVI(R)VDD(R)VDD ppm VDD(R)
24 VVI(R)ppmVDD(R)ppm VVI(R)VDD(R) VDD(R) VVI(R) ppm ON OFFOFF AAI(R)VVI(R)AAI(R) ms DDD ppm
25 ON OFFOFF InhibitVDD % Asynchronous VDD VDDVDD ppm Inhibit / Asynchronous False Positive Inhibit / Asynchronous ppm False Negative False PositiveFalse Negative cm cmcm
26 mv
27 cm cm cmcm cm cm cmcm cm
28 (C) mcm cm (A) (B)
29 mcm cm (D)
30 (E) Inhibit VDDVDD Asynchronous False Positive Inhibit / Asynchronous False Negative
31 - 20 -
32 - 21 -
33 ICD
34 /ICD Inhibit Asynchronous ICD VVI(R) 5cm 5 ICD/ /ICD Inhibit Asynchronous ICD VVI(R) 5cm 5 ICD/
35 /ICD Inhibit Asynchronous 5cm 5 ICD/ /ICD Inhibit Asynchronous 5cm 5 ICD/
36 VDD Inhibit, Asynchronous VDD 5cm 5 VDD Inhibit, Asynchronous VDD 5cm 5
37 - 26 -
38 cm cm cm cm
39 - 28 -
40 - 29 -
41 - 30 -
42 cm Inhibit
43 Asynchronous %
44 - 33 -
45 cm False PositiveInhibitAsynchronous cm cm cm
46 - 35 -
47 - 36 -
48
49 - 38 -
50 False Positive %
51 %% InInhibit AsAsynchronous
52 InInhibit
53 InInhibit AsAsynchronous ae
54 cm
55 cm cm A 1/ cm 20.0 cm 0.0 cm B 1/ cm 20.0 cm 0.0 cm 1/ cm 20.0 cm 0.0 cm a b c c VVI VVI AAI VVI In As In As In As In As a a b b AAI VVI AAI VVI In As In As In As In As c d d VVI AAI VVI In As In As In As C a b VVI VVI In As In As 1/ cm InInhibit 20.0 cm AsAsynchronous 0.0 cm
56 IrnichJOURNAL OF PACING AND CLINIKAL ELECTROPH YSIOLOGYcm 2 cm 2 cm 2 cm 2 % cm 2 cm 2 Irnichcm 2 cm 2 cm 2 cm mm 340 cm
57 cm 2 cm 2 cm 2 cm
58 cm 2 cm 2
59 cm 2 cm 2
60 - 49 -
61 - 50 -
62 MedWatch, Food and Drug Adm inistration, HF-, Fishers Lane, Rockville, MD
63 CDRH, Office of Su rveillance and Biometrics, HFZ-, Piccard Drive, Rockville, MD, E nap@cdrh.fda. D
64 TEPRSSC
65 TEPRSSC
66 CDRH, Office of Compliance(HFZ-), Gaither Rd, Rockville, fax M Office of Compliance Center of Devices and Radiological Health
67 : Medical Devices Agency
68 - 57 -
69 - 58 -
70 - 59 -
71 - 60 -
72 Susanne Ludgate -Clinical Tel: FAX: Peter M SolesburyJohn Shaw Implants & Materials Section Tel: FAX: Medical Devices Agency, Hannibal House, Elephant & Castle, London SE1 TQ Business Servic es, Device Technology & Safety Medical Devices Agency National Pacemaker D atabase(po, Bridge of Weir, Strathclyde, PA11 DZ Implants & MaterialsWeb(
73 w.medical-devices.gov.uk/-dts.htm) Adverse Incident Centre(AIC), Medical Devices Agency, Hannibal House, Elephant & Castle, London SE TQ (C) Crown Copyright
74 - 63 -
75 cm cm cm cm cm
76 % % cm 2 cm 2 Irnichcm
77 cm 2 cm 2 cm 2 cm 2 %
78 - 67 -
79 - 68 -
80 Institute of Electrical and Electronics Engineers Inc. GHz
81 SSI
82 DDD VDD VDD ICD-S ICD-D AAI P VVI QRS SSI AAIVVI DDD AAIVVIAV VDD P AV ICD-S VFVT SSI ICD-D VFVT DDD
83 Inf rastructure modead-hoc mode Ethernet LAN () LAN () GHz Mbps Mbps GHz GHz
84 GHz RCR STDFrequency Hopping, Direct Spread, Carrier Sense Multiple Access with Collision Avoidance, Mbps MHz mw GHz ARIB STD-T Mbps MHz mw 2.4GHz ARIB STD-T Orthogonal Frequency Division Multiplexing, Mbps MHz mw GHz ARIB STD-T
85 Mbps MHz mw IEEEb.g GHz GHz
86 % Medtronic mm
87 k
88 m VCCI AAI(R)VVI(R) ppm AAI(R)VVI(R) DDD
89 ppm VDD VVI(R)VDD(R)VDD ppm VDD(R) VVI(R) ppmvdd(r)ppm VVI(R)VDD(R) VDD(R) VVI(R) ppm ON OFFOFF AAI(R)VVI(R)AAI(R)
90 ms DDD ppm ON OFFOFF Inhibit VDD % (ppm) Asynchronous VDD VDDVDD ppm Inhibit / Asynchronous (False Positive)False Positive Inhibit / Asynchronous (ppm)
91 (False Negative)False Negative (False Positive) (False Negative) cm mv
92 L H
93 Inhibit VDD VDD Asynchronous False Positive Inhibit / Asynchronous False Negative
94 - 83 -
95 ICD
96 /ICD Inhibit Asynchronous ICD 5 ICD
97 /ICD Inhibit Asynchronous 5 ICD
98 VDD Inhibit, Asynchronous VDD
99 %cm cm % cm Inhibit
100 - 89 -
101
102 - 91 -
103 cm cm
104 GHz GHz Fixed Wireless Access
105 Radio Frequency Identification
106 SSI DDD VDD VDD
107 ICD-S ICD-D AAI P VVI QRS SSI AAIVVI DDD AAIVVIAV VDD P ICD-S VFVT SSI ICD-D VFVT DDD
108 - 97 -
109 a b c
110 %
111 Medtronic mm k
112 m VCCI
113 AAI(R)VVI(R) ppm AAI(R)VVI(R) DDD ppm VDD VVI(R)VDD(R)VDD ppm VDD(R)
114 VVI(R) ppmvdd(r)ppm VVI(R)VDD(R) VDD(R) VVI(R) ppm ON OFFOFF AAI(R)VVI(R)AAI(R) ms DDD ppm ON
115 OFFOFF Inhibit VDD % (ppm) Asynchronous VDD VDDVDD ppm Inhibit / Asynchronous (False Positive)False Positive Inhibit / Asynchronous (ppm) (False Negative)False Negative (False Positive) (False Negative ) H cm
116 L D D H cm L mv
117 (A) D m cm cm D (A) D (B) L cm cm cm cm (C) L cm cm cm L
118 (C) (A) (B)
119 D m cm cm D (D) L L
120 L H
121 Inhibit VDD VDD Asynchronous False Positive Inhibit / Asynchronous False Negative
122
123 ICD
124 /ICD Inhibit Asynchronous ICD VVI(R) 5cm 5 ICD/ /ICD Inhibit Asynchronous ICD VVI(R) 5cm 5 ICD/
125 /ICD Inhibit Asynchronous 5cm 5 ICD/ /ICD Inhibit Asynchronous 5cm 5 ICD/
126 VDD Inhibit, Asynchronous VDD 5cm 5 VDD Inhibit, Asynchronous VDD 5cm 5
127 /ICD Inhibit Asynchronous ICD VVI(R) 5 ICD /
128 /ICD Inhibit Asynchronous 5 ICD /
129 VDD Inhibit, Asynchronous VDD
130 cm
131 Inhibit Inhibit
132 Inhibit Asynchronous Asynchronous %
133 a b c Asynchronous
134
135
136 False Positive
137 % cm
138 Inhibit mvmvmvmv cm cmcm
139 %cm % cm False Positive cm
140
141 cm cm cm
142 cm cm cm cm cm
143
144
145 - 0 -
146 - 1 -
147 - 2 -
148 EAS - 3 -
149 - 4 -
150 4 () - 5 -
151 NTT EMC RFID EAS () EMC - 6 -
152 EAS () EAS EAS () EAS EMC EMC CRM - 7 -
153 NTT EMC NTT EMC EMC EMC CRM - 8 -
154 NTT EMC NTT EMC RFID EMC EMC CRM - 9 -
155
156 - 11 -
157 - 12 -
158 - 13 -
159 - 14 -
160 - 15 -
161
SC-85X2取説
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