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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

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