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--------------------------------------------------------------------------------------------------- 16 --------------------------------------------------------------------------------------------------- 18 ----------------------------------------------------------------------------- 19 --------------------------------------------------------------------------------------------- 19 ------------------------------------------- 20 ----------------------------------------------------------------- 22 /ICD ------------------------------ 23 /ICD ------------------------------ 24 VDD --------------------------------------- 25 -------------------------26 ----------------------------------------------------------------- 26 ------------ 26 -------------------------------------------------------------- 26 ----------------------------------------------------------------------------------- 26 ----------------------------------------------------------------------- 27 ----------------------------------------------------------------------------------------------- 27 ------------ 31 -------------------------------------------------------------- 31 ----------------------------------------------------------------------------------- 31 --------------- 31 -------------------------------------------------------------- 31 ------------------------------------------- 31 Inhibit -------------------------------------------------------------------------------------------- 31 Asynchronous---------------------------------------------------------------------------------- 32 ----------------------------------------------------------------------------- 33 ------------------------ 33 ---------------------------------- 33 ------------------------------------------- 34 ----------------------------------------------------------------------------------- 34 - ii -

----------------------------------------------------------------------- 34 ------------------------------------------------------------------------------------------------ 34 ------------------------ 38 ---------------------------------- 38 ------------------------------------------- 38 --------------------------- 38 ---------------------------------- 38 ------------------------------------------- 38 ------------------------------------------------------- 39 -------------------------------------------------- 39 ------------------- 43 ---------------------------------------------- 45 ----------------------------------------------------------------------------- 49 ------------------------------------------------------------------------------------ 49 -------------------------------------------------------------------------------------------- 49 ------------------------------------------------------------------------------------ 49 --------------------------------------------------------------------------------------------- 50 ------------------------------------------------------------------------ 50 -------------------------------------------------------------------- 50 ------------------ 50 ----------------------------------------------------------------------------- 51 ---------------------------------------------------------------------------- 51 ---------------------------------------------------------------------------------------- 51 ------------------------------------------------------------------ 51 -------------------------------------------------------- 53 ------------------------------------------------------------------------------------- 53 ------------------------------------------------------------------------------- 53 ----------------------------------------------------------------------------------------------- 54 - iii -

--------------------------------------------------------------------- 56 ----------------------------------------------------------------------------------------------- 56 ------------------------------------------------------------------------------- 56 ----------------------------------------------------------------------------------------------- 56 ----------------------------------------------------------------------------------------------------- 56 ------------------------------------------------------------------------------------------ 56 ----------------------------------------------------------------------------------------------- 57 ----------------------------------------------------------------------------------------------- 57 ----------------------------------------------------------------------------------------------- 58 ------------------------------------- 58 ---------------------------------------------- 58 ------------------------------------------------------------------- 59 -------------------------------------------------------------------------------- 59 --------------------------------------------------------------------------------------------- 60 ---------------------------------------------------------------------------------------- 61 ----------------------------------------------------- 61 -------------------------------------------------- 61 -------------------------------------------------------------63 ------------------------------------------------------------------------------------------ 63 -------------------------------------------------------------------------------------------- 63 -------------------------------------------------------------------------------------------------- 63 ----------------------------------------------------------------------- 66 ------------------- 67 -------------------------------------------------------------------------------------------- 67 ------------------------------------------------------------------------------- 69 - iv -

-------------------------------------------------------------------------------------- 70 -------------------------------------------------------------------------------------- 70 ------------------------------------------------------- 70 ------------------------------------------------------------------------- 72 ---------------------------------------------------------------------------- 72 ---------------------------------------------------------------------------- 73 ------------------------------------------------------------------- 74 ----------------------------------------------------------------------------------- 75 --------------- 75 ---------------------------------------------------------------------- 76 ---------------------------------------------------------------------------- 77 -------------------------------------------------------------------------------------------- 77 ------------------------------- 77 ---------------------------------------- 79 ------ 80 -------------------------------------------------------------------------------------------- 80 ---------------------------------------- 80 ----------------------------------------------------------------------------------- 80 -------------------------------------------------------------------------------------------- 80 -------------------------------------------------------------------------------------------- 81 ---------------------------------------------------------------------- 81 -------------------------------------------------------------------------------------- 81 ------------------------------------- 82 ---------------------------------------------------------- 84 /ICD --------------------------- 85 /ICD--------------------------- 86 VDD------------------------------------ 87 ---------------------- 88 - v -

---------------------------------------------------- 88 ------------------------------------------ 88 --------------------------------------------------------------------- 88 ------------------------------------------------------------------------------ 88 ----------------------------------------- 89 ------------------------------------------------------------- 90 ---------------------------------------------------------- 90 --------------------------------------------------------------------------- 90 ------------------------------------------------------------------------ 90 -------------------------------------------------------------------- 91 --------------------------------------------------------------------------- 91 ------------------------------------------------------------------------ 91 ------------------------------------------------------- 92 ----------------------------------------------------------------------------------- 92 ---------------------------------------------------------------------------- 92 ----------------------------------------------------------------------------------- 92 ------------- 93 ----------------------------------------------------------------------------------------- 93 --------------------------------------------------------------------------------- 94 -------------------------------------------------------------------------------------- 95 -------------------------------------------------------------------------------------- 95 ------------------------------------------------------- 95 ----------------------------------------------------------------------------- 97 ------------------------------------------------------------------------- 97 ------------------------------------------------------------------------- 97 - vi -

---------------------------------------------------------------------- 99 ----------------------------------------------------------------------------------- 99 ---------------- 99 --------------------------------------------------------------------- --------------------------------------------------------------------------- -------------------------------------------------------------------------------------------102 ------------------------------102 ---------------------------------------104 --104 -----------------------------------------------------104 --------------------------------------------------105 -------------------------------------------------------------------------------------------105 ---------------------------------------105 ------------------------------------------105 -------------------------------------------------------------------------------------------106 -------------------------------------------------------------------------------------------106 -------------------------------------------------------------------------------------------106 -------------------------------------------------------------------------------------------107 ---------------------------------------108 -------------------------------------------------------------------------------------------108 -------------------------------------------------------------------------------------------109 ---------------------------------------------------------------------109 -------------------------------------------------------------------------------------109 ------------------------------------110 ---------------------------------------------------------112 ------------------------------------112 /ICD ----------------------113 /ICD ----------------------114 VDD-------------------------------115 -----------------------------------116 - vii -

/ICD ----------------------116 /ICD ----------------------117 VDD-------------------------------118 ---------------------119 --------------------------------------------------119 ------------------------------------------119 -------------------------------------------------------119 ---------------------------------------------------------------------------119 ------------------------------------------------------------------------120 ----------------------------------------------120 ---------------------------------------------------------------------------------------122 ------------------------------------------------------124 ------------------------------124 ---------------------------------------125 -----------------------------------------------------------------125 ----------------------------------------------125 ------------------------------------------125 ---------------------------------------------------------------------------------------125 --------------------126 ------------------------------------------------------128 ---------------------------------------------------------------128 -------------------------------------------------------------------------128 ---------------------------------------------------------------128 ------------------------------------------------------129 ----------------------------------------------------------------------------------129 ---------------------------------------------------------------------------129 ----------------------------------------------------------------------------------129 ------------------------------------------------------129 - viii -

---------------------------------------------------130 130 ------------------------------------------------------131 ---------------------------------------------------131 -----------------------131 -------------------------------------------------------------------------------------131 ------------------------------------------------------------------------132 ------------------------ 1 ------------------------------------------------------------------------------------------- 5 ---------------------- 10 ------------------------------------------------------------- 16 - ix -

Electronic Article Surveillance - 1 -

SSI DDD VDD VDD ICD-S ICD-D - 2 -

AAI P VVI QRS SSI AAIVVI DDD AAIVVIAV VDD P ICD-S VFVT SSI ICD-D VFVT DDD - 3 -

MHz khz - 4 -

MHz MHz GHzkHz HzkHz khzkhz khz ONOFF - 5 -

- 6 -

Medtronic Irnich cm 2 cm 2 cm 2 cm 2-7 -

Irnich cm 2 30 360 75 30 360 mm 340 5 25-8 -

Ω - 9 -

m cm mm - 10 -

20cm 2.7m2.5m - 11 -

AAI(R)VVI(R) ppm AAI(R)VVI(R) DDD ppm VDD VVI(R)VDD(R)VDD ppm VDD(R) - 12 -

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 - 13 -

ON OFFOFF InhibitVDD % Asynchronous VDD VDDVDD ppm Inhibit / Asynchronous False Positive Inhibit / Asynchronous ppm False Negative False PositiveFalse Negative cm cmcm - 14 -

mv - 15 -

cm cm cmcm cm cm cmcm cm - 16 -

mcm cm - 18 - (D)

(E) Inhibit VDDVDD Asynchronous False Positive Inhibit / Asynchronous False Negative - 19 -

- 20 -

- 21 -

ICD - 22 -

- 23 - /ICD Inhibit Asynchronous ICD VVI(R) 5cm 5 ICD/ /ICD Inhibit Asynchronous ICD VVI(R) 5cm 5 ICD/

- 24 - /ICD Inhibit Asynchronous 5cm 5 ICD/ /ICD Inhibit Asynchronous 5cm 5 ICD/

- 25 - VDD Inhibit, Asynchronous VDD 5cm 5 VDD Inhibit, Asynchronous VDD 5cm 5

- 26 -

cm cm cm cm - 27 -

- 28 -

- 29 -

- 30 -

cm Inhibit - 31 -

Asynchronous % - 32 -

- 33 -

cm False PositiveInhibitAsynchronous cm cm cm - 34 -

- 35 -

- 36 -

- 37-9013590

- 38 -

False Positive % - 39 -

%% InInhibit AsAsynchronous - 40 -

InInhibit - 41 -

InInhibit AsAsynchronous ae - 42 -

cm - 43 -

cm cm A 1/2 35.0 cm 20.0 cm 0.0 cm B 1/2 60.0 cm 20.0 cm 0.0 cm 1/2 60.0 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 1/2 42.5 cm InInhibit 20.0 cm AsAsynchronous 0.0 cm - 44 -

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 2 30 360 360 mm 340 cm 2 5 25-45 -

cm 2 cm 2 cm 2 cm 2-46 -

- 47 - cm 2 cm 2

- 48 - cm 2 cm 2

- 49 -

- 50 -

MedWatch, Food and Drug Adm inistration, HF-, Fishers Lane, Rockville, MD - 51 -

CDRH, Office of Su rveillance and Biometrics, HFZ-, Piccard Drive, Rockville, MD, E nap@cdrh.fda. http://www.fda.gov/cdrh/safety.html http://www.fda.gov/cdrh/emc/index.html D. - 52 -

TEPRSSC - 53 -

TEPRSSC - 54 -

CDRH, Office of Compliance(HFZ-), Gaither Rd, Rockville, MD,sbb@cdrh.fda.gov, fax M Office of Compliance Center of Devices and Radiological Health - 55 -

: Medical Devices Agency - 56 -

- 57 -

- 58 -

- 59 -

- 60 -

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(http://ww - 61 -

w.medical-devices.gov.uk/-dts.htm) Adverse Incident Centre(AIC), Medical Devices Agency, Hannibal House, Elephant & Castle, London SE TQ (C) Crown Copyright - 62 -

- 63 -

cm cm cm cm cm - 64 -

% % cm 2 cm 2 Irnichcm 2-65 -

cm 2 cm 2 cm 2 cm 2 % - 66 -

- 67 -

- 68 -

Institute of Electrical and Electronics Engineers Inc. GHz - 69 -

SSI - 70 -

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 - 71 -

Inf rastructure modead-hoc mode Ethernet LAN () LAN () GHz Mbps Mbps GHz GHz - 72 -

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 - 73 -

Mbps MHz mw IEEEb.g GHz GHz - 74 -

% Medtronic 30 360 75 30 360 mm 340 5 25-75 -

k - 76 -

m VCCI AAI(R)VVI(R) ppm AAI(R)VVI(R) DDD - 77 -

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) - 78 -

ms DDD ppm ON OFFOFF Inhibit VDD % (ppm) Asynchronous VDD VDDVDD ppm Inhibit / Asynchronous (False Positive)False Positive Inhibit / Asynchronous (ppm) - 79 -

(False Negative)False Negative (False Positive) (False Negative) cm mv - 80 -

L H - 81 -

Inhibit VDD VDD Asynchronous False Positive Inhibit / Asynchronous False Negative - 82 -

- 83 -

ICD - 84 -

/ICD Inhibit Asynchronous ICD 5 ICD - 85 -

/ICD Inhibit Asynchronous 5 ICD - 86 -

VDD Inhibit, Asynchronous VDD 5-87 -

%cm cm % cm Inhibit - 88 -

- 89 -

0.0 1.1 2.1 5.1 10.1 1.0 2.0 5.0 10.0 20.0-90 -

- 91 -

cm cm - 92 -

GHz GHz Fixed Wireless Access - 93 -

Radio Frequency Identification - 94 -

SSI DDD VDD VDD - 95 -

ICD-S ICD-D AAI P VVI QRS SSI AAIVVI DDD AAIVVIAV VDD P ICD-S VFVT SSI ICD-D VFVT DDD - 96 -

- 97 -

a b c - 98 -

% - 99 -

Medtronic 360 30 360 75 30 mm 340 5 25 k - 100 -

m VCCI - 101 -

AAI(R)VVI(R) ppm AAI(R)VVI(R) DDD ppm VDD VVI(R)VDD(R)VDD ppm VDD(R) - 102 -

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 - 103 -

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 - 104 -

L D D H cm L mv - 105 -

(A) D m cm cm D (A) D (B) L cm cm cm cm (C) L cm cm cm L - 106 -

D m cm cm D (D) L L - 108 -

L H - 109 -

Inhibit VDD VDD Asynchronous False Positive Inhibit / Asynchronous False Negative - 110 -

- 111 -

ICD - 112 -

- 113 - /ICD Inhibit Asynchronous ICD VVI(R) 5cm 5 ICD/ /ICD Inhibit Asynchronous ICD VVI(R) 5cm 5 ICD/

- 114 - /ICD Inhibit Asynchronous 5cm 5 ICD/ /ICD Inhibit Asynchronous 5cm 5 ICD/

- 115 - VDD Inhibit, Asynchronous VDD 5cm 5 VDD Inhibit, Asynchronous VDD 5cm 5

/ICD Inhibit Asynchronous ICD VVI(R) 5 ICD / - 116 -

/ICD Inhibit Asynchronous 5 ICD / - 117 -

VDD Inhibit, Asynchronous VDD 5-118 -

cm - 119 -

Inhibit Inhibit - 120 -

Inhibit Asynchronous Asynchronous % - 121 -

a b c Asynchronous - 122 -

- 123 -

- 124 -

False Positive - 125 -

% cm - 126 -

Inhibit mvmvmvmv cm cmcm - 127 -

%cm % cm False Positive cm - 128 -

- 129 -

cm cm cm - 130 -

cm cm cm cm cm - 131 -

- 132 -

- 0 -

- 1 -

- 2 -

EAS - 3 -

- 4 -

4 () - 5 -

NTT EMC RFID EAS () EMC - 6 -

EAS () EAS EAS () EAS EMC EMC CRM - 7 -

NTT EMC NTT EMC EMC EMC CRM - 8 -

NTT EMC NTT EMC RFID EMC EMC CRM - 9 -

15 7 24 2-10 -

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2002 12-16 -