DCD Test Report

FCC ID: LF537602

Test Report

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FCCID_3864553

ee RF Test Reports Report No.: FCC_RF_SL17121901-MED-023 (37602) Supersede Report No.: N/A Applicant Medtronic, Inc. Product Name Itrel 4 Model No. 37602 Test Standard 47 CFR 15.209 Test Method ANSI C63.10: 2013 Date of test 02/27/2018 Issue Date 02/28/2018 Test Result ☒ Pass ☐ Fail Equipment complied with the test standard equipment [x] Equipment did not comply with the test standard equipment [ ] This Test Report is Issued Under the Authority of: Cipher Chen Ge Test Engineer Engineer Reviewer This test report may be reproduced in full only Test result presented in this test report is applicable to the tested sample only Issued By: SIEMIC Laboratories 775 Montague Expressway, Milpitas, CA 95035 775 Montague Expressway, Milpitas, CA 95035, USA • Phone: (+1) 408 526 1188 • Facsimile (+1) 408 526 1088 Visit us at: www.siemic.com; Follow us at:

Test report No. FCC_RF_SL17121901-MED-023 (37602) Page 2 of 17 Laboratory Introduction SIEMIC, headquartered in the heart of Silicon Valley, with superior facilities in US and Asia, is one of the leading independent testing and certification facilities providing customers with one-stop shop services for Compliance Testing and Global Certifications. In addition to testing and certification, SIEMIC provides initial design reviews and compliance management throughout a project. Our extensive experience with China, Asia Pacific, North America, European, and International compliance requirements, assures the fastest, most cost effective way to attain regulatory compliance for the global markets. Accreditations for Conformity Assessment Country/Region Accreditation Body Scope USA FCC, A2LA EMC, RF/Wireless, Telecom Canada IC, A2LA, NIST EMC, RF/Wireless, Telecom Taiwan BSMI, NCC, NIST EMC, RF, Telecom, Safety Hong Kong OFTA, NIST RF/Wireless, Telecom Australia NATA, NIST EMC, RF, Telecom, Safety Korea KCC/RRA, NIST EMI, EMS, RF, Telecom, Safety Japan VCCI, JATE, TELEC, RFT EMI, RF/Wireless, Telecom Mexico NOM, COFETEL, Caniety EMC, RF/Wireless, Telecom, Safety Europe A2LA, NIST EMC, RF, Telecom, Safety Israel MOC, NIST EMC, RF, Telecom, Safety Accreditations for Product Certifications Country Accreditation Body Scope USA FCC TCB, NIST EMC, RF, Telecom Canada IC FCB, NIST EMC, RF, Telecom Singapore iDA, NIST EMC, RF, Telecom EU NB EMC & R&TTE Directive Japan MIC (RCB 208) RF, Telecom Hong Kong OFTA (US002) RF, Telecom 775 Montague Expressway, Milpitas, CA 95035, USA • Phone: (+1) 408 526 1188 • Facsimile (+1) 408 526 1088 Visit us at: www.siemic.com; Follow us at:

Test report No. FCC_RF_SL17121901-MED-023 (37602) Page 3 of 17 CONTENTS 1 REPORT REVISION HISTORY ....................................................................................................................................... 4 2 EXECUTIVE SUMMARY................................................................................................................................................. 5 3 CUSTOMER INFORMATION .......................................................................................................................................... 5 4 TEST SITE INFORMATION ............................................................................................................................................ 5 5 EQUIPMENT UNDER TEST (EUT) INFORMATION .......................................................................................................... 5 5.1 EUT Description ........................................................................................................................................................ 5 5.2 Radio Description ...................................................................................................................................................... 6 6 SUPPORTING EQUIPMENT/SOFTWARE AND CABLING DESCRIPTION......................................................................... 7 6.1 Supporting Equipment ............................................................................................................................................... 7 6.2 I/O Ports ................................................................................................................................................................... 7 6.3 Test Software Description .......................................................................................................................................... 7 7 TEST SUMMARY ........................................................................................................................................................... 8 8 MEASUREMENT UNCERTAINTY ................................................................................................................................... 9 8.1 Radiated Emissions (9kHz to 30MHz).......................................................................................................................... 9 8.2 Radiated Emissions (30MHz to 1GHz)......................................................................................................................... 9 8.3 Radiated Emissions (1GHz to 40GHz) ....................................................................................................................... 10 8.4 RF conducted measurement .................................................................................................................................... 10 9 MEASUREMENTS, EXAMINATION AND DERIVED RESULTS ....................................................................................... 11 9.1 Antenna Requirement .............................................................................................................................................. 11 9.2 Radiated Spurious Emissions below 30MHz .............................................................................................................. 12 ANNEX A. TEST INSTRUMENT & METHOD ........................................................................................................................ 15 ANNEX B. SIEMIC ACCREDITATION ................................................................................................................................... 16 775 Montague Expressway, Milpitas, CA 95035, USA • Phone: (+1) 408 526 1188 • Facsimile (+1) 408 526 1088 Visit us at: www.siemic.com; Follow us at:

Test report No. FCC_RF_SL17121901-MED-023 (37602) Page 4 of 17 1 Report Revision History Report No. Report Version Description Issue Date FCC_RF_SL17121901-MED-023 (37602) None Original Report 02/28/2018 775 Montague Expressway, Milpitas, CA 95035, USA • Phone: (+1) 408 526 1188 • Facsimile (+1) 408 526 1088 Visit us at: www.siemic.com; Follow us at:

Test report No. FCC_RF_SL17121901-MED-023 (37602) Page 5 of 17 2 Executive Summary The purpose of this test program was to demonstrate compliance of following product Company: Medtronic, Inc. Product: Itrel 4 Model: 37602 against the current Stipulated Standards. The specified model product stated above has demonstrated compliance with the Stipulated Standard listed on 1st page. 3 Customer information Applicant Name Medtronic, Inc. Applicant Address 710 Medtronic Parkway N.E., Minneapolis, MN 55432 Manufacturer Name Medtronic, Inc. Manufacturer Address 710 Medtronic Parkway N.E., Minneapolis, MN 55432 4 Test site information Lab performing tests SIEMIC Laboratories Lab Address 775 Montague Expressway, Milpitas, CA 95035 FCC Test Site No. 881796 IC Test Site No. 4842D-2 VCCI Test Site No. A0133 5 Equipment Under Test (EUT) Information 5.1 EUT Description Product Name Itrel 4 Model No. 37602 Trade Name Medtronic Serial No. NMX700557H Input Power Battery Power 3.0V Date of EUT received 12/21/2017 Equipment Class/ Category ULP-AMI-P, Class 3 775 Montague Expressway, Milpitas, CA 95035, USA • Phone: (+1) 408 526 1188 • Facsimile (+1) 408 526 1088 Visit us at: www.siemic.com; Follow us at:

Test report No. FCC_RF_SL17121901-MED-023 (37602) Page 6 of 17 5.2 Radio Description Radio Parameters Operating Frequency 175 KHz Modulation OOK burst Channel Spacing Single Channel Operation Antenna Type Integral loop antenna/External antenna Antenna Gain None Channel List Type Channel No. Frequency (KHz) ULP-AMI 1 175 775 Montague Expressway, Milpitas, CA 95035, USA • Phone: (+1) 408 526 1188 • Facsimile (+1) 408 526 1088 Visit us at: www.siemic.com; Follow us at:

Test report No. FCC_RF_SL17121901-MED-023 (37602) Page 7 of 17 6 Supporting Equipment/Software and cabling Description 6.1 Supporting Equipment Supporting Equipment Serial Item Model Manufacturer Note Description Number 1 InterStim ICon 3037 N/A Medtronic N/A 6.2 I/O Ports Connection Start Connection Stop Length / shielding Info Item Note From I/O Port To I/O Port Length (m) Shielding N/A N/A N/A N/A N/A N/A N/A N/A 6.3 Test Software Description Test Item Software Description Provided by manufacturer to set EUT in continuous RF Testing N/A mode 775 Montague Expressway, Milpitas, CA 95035, USA • Phone: (+1) 408 526 1188 • Facsimile (+1) 408 526 1088 Visit us at: www.siemic.com; Follow us at:

Test report No. FCC_RF_SL17121901-MED-023 (37602) Page 8 of 17 7 Test Summary Test Item Test standard Test Method/Procedure Pass / Fail ☒ Pass Antenna Requirement FCC 47 CFR 15.203 FCC ANSI C63.10 – 2013 ☐ N/A ☒ Pass Radiated Spurious Emissions FCC 47 CFR 15.209 FCC ANSI C63.10: 2013 ☐ N/A ☐ Pass AC Conducted Emissions FCC 47 CFR 15.207 FCC ANSI C63.10: 2013 ☒ N/A 1. All measurement uncertainties are not taken into consideration for all presented test result. Remark 2. The applicant shall ensure frequency stability by showing that an emission is maintained within the band of operation under all normal operating conditions as specified in the user’s manual. 3. EUT is a DC powered device. 775 Montague Expressway, Milpitas, CA 95035, USA • Phone: (+1) 408 526 1188 • Facsimile (+1) 408 526 1088 Visit us at: www.siemic.com; Follow us at:

Test report No. FCC_RF_SL17121901-MED-023 (37602) Page 9 of 17 8 Measurement Uncertainty 8.1 Radiated Emissions (9kHz to 30MHz) The test is to measure the radiated emissions of the EUT. Some error sources that can contribute to the total uncertainty: - Uncertainty of the receiver - Uncertainty of the antenna - Uncertainty of cables - Uncertainty due to the mismatches Value Probability Sensitivity Expanded Source of Uncertainty Division (dB) Distribution Coefficient Uncertainty Receiver Reading 0.10 Rectangular 1.732 1 0.069284 Cable Insertion Loss 0.21 Normal 2 1 0.105 Antenna Factor 0.65 Normal 2 1 0.325 Receiver CW accuracy 0.45 Rectangular 1.732 1 0.2598152 Mismatch 0.25 U-Shape 1.414 1 0.1768033 Combined Standard Uncertainty 0.935 Expanded Uncertainty (K=2) 1.87 The total derived measurement uncertainty is +/- 1.87 dB. 8.2 Radiated Emissions (30MHz to 1GHz) The test is to measure the radiated emissions of the EUT. Some error sources that can contribute to the total uncertainty: - Uncertainty of the receiver - Uncertainty of the antenna - Uncertainty of cables - Uncertainty due to the mismatches - NSA Calibration - Etc., details see the below table Value Probability Sensitivity Expanded Source of Uncertainty Division (dB) Distribution Coefficient Uncertainty Receiver Reading 0.12 Rectangular 1.732 1 0.069284 Cable Insertion Loss 0.21 Normal 2 1 0.105 Filter Insertion Loss 0.25 Normal 2 1 0.125 Antenna Factor 0.65 Normal 2 1 0.325 Receiver CW accuracy 0.5 Rectangular 1.732 1 0.2886836 Pulse Amplitude Response 1.5 Rectangular 1.732 1 0.86605081 PRF Response 1.5 Rectangular 1.732 1 0.86605081 Mismatch Filter - Receiver 0.25 U-Shape 1.414 1 0.1768033 NSA Calibration 4.0 U-Shape 1.414 1 2.8288543 Combined Standard Uncertainty 3.0059131 Expanded Uncertainty (K=2) 6.0118262 The total derived measurement uncertainty is +/- 6.00 dB. 775 Montague Expressway, Milpitas, CA 95035, USA • Phone: (+1) 408 526 1188 • Facsimile (+1) 408 526 1088 Visit us at: www.siemic.com; Follow us at:

Test report No. FCC_RF_SL17121901-MED-023 (37602) Page 10 of 17 8.3 Radiated Emissions (1GHz to 40GHz) The test is to measure the radiated emissions of the EUT. Some error sources that can contribute to the total uncertainty: - Uncertainty of the receiver - Uncertainty of the antenna - Uncertainty of cables - Uncertainty due to the mismatches - VSWR Calibration - Etc., details see the below table Value Probability Sensitivity Expanded Source of Uncertainty Division (dB) Distribution Coefficient Uncertainty Receiver Reading 0.12 Rectangular 1.732 1 0.0692840 Cable Insertion Loss 0.21 Normal 2 1 0.1050000 Filter Insertion Loss 0.25 Normal 2 1 0.1250000 Antenna Factor 0.65 Normal 2 1 0.3250000 Receiver CW accuracy 0.5 Rectangular 1.732 1 0.2886836 Pulse Amplitude Response 1.5 Rectangular 1.732 1 0.8660508 PRF Response 1.5 Rectangular 1.732 1 0.8660508 Mismatch Filter - Receiver 0.25 U-Shape 1.414 1 0.1768033 VSWR Calibration 2.0 U-Shape 1.414 1 1.4144272 Combined Standard Uncertainty 4.2363 Expanded Uncertainty (K=2) 8.4726 The total derived measurement uncertainty is +/- 8.47 dB. 8.4 RF conducted measurement The test is to measure the RF output power from the EUT. Some error sources that can contribute to the total uncertainty: - Uncertainty of the Reference Level Uncertainty - Uncertainty of variable attenuators - Uncertainty of cables - Uncertainty due to the mismatches Value Probability Division Sensitivity Expanded Source of Uncertainty (dB) Distribution Coefficient Uncertainty Reference Level 0.12 Rectangular 1.732 1 0.069284 Cable Insertion Loss 0.21 Normal 2 1 0.105 Attenuator 0.25 Normal 2 1 0.125 Mismatch 0.25 U-Shape 1.414 1 0.1768033 Combined Standard Uncertainty 0.476087 Expanded Uncertainty (K=2) 0.952174 The total derived measurement uncertainty is +/- 0.95 dB. 775 Montague Expressway, Milpitas, CA 95035, USA • Phone: (+1) 408 526 1188 • Facsimile (+1) 408 526 1088 Visit us at: www.siemic.com; Follow us at:

Test report No. FCC_RF_SL17121901-MED-023 (37602) Page 11 of 17 9 Measurements, Examination and Derived Results 9.1 Antenna Requirement Spec Requirement Applicable An intentional radiator shall be designed to ensure that no antenna other than that furnished by the responsible party shall be used with the device. Antenna requirement must meet at least one of the following: §15.203 ☒ a) Antenna must be permanently attached to the device. b) The antenna must use a unique type of connector to attach to the device. c) Device must be professionally installed. The installer shall be responsible for ensuring that the correct antenna is employed by the device. Remark The EUT has an integrated antenna which meets the requirement. Result ☒ PASS ☐ FAIL 775 Montague Expressway, Milpitas, CA 95035, USA • Phone: (+1) 408 526 1188 • Facsimile (+1) 408 526 1088 Visit us at: www.siemic.com; Follow us at:

Test report No. FCC_RF_SL17121901-MED-023 (37602) Page 12 of 17 9.2 Radiated Spurious Emissions below 30MHz Requirement(s): Item Requirement Applicable Except higher limit as specified elsewhere in other section, the emissions from the low- power radio-frequency devices shall not exceed the field strength levels specified in the following table and the level of any unwanted emissions shall not exceed the level of the fundamental emission. The tighter limit applies at the band edges FCC 15.209 1 ☒ Measurement Frequency range (MHz) Field Strength (uV/m) distance (meters) 0.009-0.490 2400/F(kHz) 300 0.490-1.705 24000/F(kHz) 30 1.705-30.0 30 30 1. The EUT was switched on and allowed to warm up to its normal operating condition. 2. The test was carried out at the selected frequency points obtained from the EUT characterisation. Maximization of the emissions, was carried out by rotating the EUT, changing the antenna polarization, and adjusting the antenna height in the following manner: a. Vertical or horizontal polarisation (whichever gave the higher emission level over a full rotation of Procedure the EUT) was chosen. b. The EUT was then rotated to the direction that gave the maximum emission. c. Finally, the antenna height was adjusted to the height that gave the maximum emission. 3. A Quasi-peak measurement was then made for that frequency point. 4. Steps 2 and 3 were repeated for the next frequency point, until all selected frequency points were measured. Temperature 21°C Test Date 02/27/2018 Environmental condition Relative Humidity 42% Atmospheric Pressure 1015mbar Remark N/A Result ☒ Pass ☐ Fail Test Data ☒ Yes ☐N/A Test Plot ☒ Yes (See below) ☐ N/A Test was done by Gary Chou at 10m chamber. 775 Montague Expressway, Milpitas, CA 95035, USA • Phone: (+1) 408 526 1188 • Facsimile (+1) 408 526 1088 Visit us at: www.siemic.com; Follow us at:

Test report No. FCC_RF_SL17121901-MED-023 (37602) Page 13 of 17 Test specification: Radiated Spurious Emissions Mains Power: 3VDC Tested by: Shuo Zhang ☒ Pass Result: ☐ Fail Test Date: 02/27/2018 Remarks: ƒ= 100kHz – 30MHz plot, and loop antenna at 0 degree Quasi Max Measurement Frequency Raw Cable AF Level Measurement Pol Hgt Azt Limit Margin Pass MHz dBuV Loss dB dBuV/m Type (0/90) cm Deg dBuV/m dB /Fail 0.55 10.28 0.39 17.65 28.32 Quasi Max 0 100 61 72.85 -44.53 Pass 1.82 17.36 0.5 8.19 26.04 Quasi Max 0 100 125 69.54 -43.5 Pass 0.18 28.21 0.28 27.17 55.66 Quasi Max 0 100 276 99.06 -43.39 Pass 10.43 21.96 0.66 1.57 24.19 Quasi Max 0 100 101 69.54 -45.35 Pass 2.12 9.72 0.51 7.08 17.31 Quasi Max 0 100 203 69.54 -52.23 Pass 10.78 15.42 0.66 1.57 17.65 Quasi Max 0 100 102 69.54 -51.89 Pass 775 Montague Expressway, Milpitas, CA 95035, USA • Phone: (+1) 408 526 1188 • Facsimile (+1) 408 526 1088 Visit us at: www.siemic.com; Follow us at:

Test report No. FCC_RF_SL17121901-MED-023 (37602) Page 14 of 17 Test specification: Radiated Spurious Emissions Mains Power: 3VDC Tested by: Shuo Zhang ☒ Pass Result: ☐ Fail Test Date: 02/27/2018 Remarks: ƒ= 100kHz – 30MHz plot, and loop antenna at 90 degree Quasi Max Measurement Frequency Raw Cable AF Level Measurement Pol Hgt Azt Limit Margin Pass MHz dBuV Loss dB dBuV/m Type (0/90) cm Deg dBuV/m dB /Fail 0.82 8.5 0.42 14.33 23.25 Quasi Max 90 100 203 69.29 -46.04 Pass 10.13 14.94 0.65 1.56 17.16 Quasi Max 90 100 283 69.54 -52.38 Pass 2.20 7.24 0.51 6.83 14.58 Quasi Max 90 100 166 69.54 -54.96 Pass 10.83 8.34 0.66 1.56 10.56 Quasi Max 90 100 105 69.54 -58.98 Pass 16.08 0.17 0.74 1.51 2.41 Quasi Max 90 100 40 69.54 -67.13 Pass 0.31 6.52 0.33 22.47 29.33 Quasi Max 90 100 50 90.58 -61.26 Pass 775 Montague Expressway, Milpitas, CA 95035, USA • Phone: (+1) 408 526 1188 • Facsimile (+1) 408 526 1088 Visit us at: www.siemic.com; Follow us at:

Test report No. FCC_RF_SL17121901-MED-023 (37602) Page 15 of 17 Annex A. TEST INSTRUMENT & METHOD Instrument Model Serial # Cal Cycle Cal Due In use SPURIOUS EMISSIONS Keysight Signal Analyzer N9030B MY57140374 1 Year 05/24/2018 Loop Antenna 6512 49120 1 Year 08/20/2018 Pre-Amplifier 8449B 3008A00715 1 Year 02/12/2019 775 Montague Expressway, Milpitas, CA 95035, USA • Phone: (+1) 408 526 1188 • Facsimile (+1) 408 526 1088 Visit us at: www.siemic.com; Follow us at:

Test report No. FCC_RF_SL17121901-MED-023 (37602) Page 16 of 17 Annex B. SIEMIC Accreditation Accreditations Document Scope / Remark ISO 17025 (A2LA) Please see the documents for the detailed scope ISO Guide 65 (A2LA) Please see the documents for the detailed scope TCB Designation A1, A2, A3, A4, B1, B2, B3, B4, C FCC DoC Accreditation FCC Declaration of Conformity Accreditation FCC Site Registration 3 meter site FCC Site Registration 3 meter site IC Site Registration 3 meter site IC Site Registration 3 meter site Radio & Telecommunications Terminal Equipment: EN45001 – EN ISO/IEC 17025 EU NB Electromagnetic Compatibility: EN45001 – EN ISO/IEC 17025 Singapore iDA Phase I, Phase II CB(Certification Body) Vietnam MIC Please see the document for the detailed scope CAB Accreditation (Phase II) OFCA Foreign Certification Body for Radio and Telecom Hong Kong OFCA (Phase I) Conformity Assessment Body for Radio and Telecom Radio: Scope A – All Radio Standard Specification in Category I Industry Canada CAB Telecom: CS-03 Part I, II, V, VI, VII, VIII 775 Montague Expressway, Milpitas, CA 95035, USA • Phone: (+1) 408 526 1188 • Facsimile (+1) 408 526 1088 Visit us at: www.siemic.com; Follow us at:

Test report No. FCC_RF_SL17121901-MED-023 (37602) Page 17 of 17 Radio: A1. Terminal equipment for purpose of calling Japan Recognized Certification Telecom: B1. Specified radio equipment specified in Article 38-2, Paragraph 1, Item Body Designation 1 of the Radio Law EMI: KCC Notice 2008-39, RRL Notice 2008-3: CA Procedures for EMI KN22: Test Method for EMI EMS: KCC Notice 2008-38, RRL Notice 2008-4: CA Procedures for EMS KN24, KN61000-4-2, -4-3, -4-4, -4-5, -4-6, -4-8, -4-11: Test Method for EMS Korea CAB Accreditation Radio: RRL Notice 2008-26, RRL Notice 2008-2, RRL Notice 2008-10, RRL Notice 2007-49, RRL Notice 2007-20, RRL Notice 2007-21, RRL Notice 2007- 80, RRL Notice 2004-68 Telecom: President Notice 20664, RRL Notice 2007-30, RRL Notice 2008-7 with attachments 1, 3, 5, 6; President Notice 20664, RRL Notice 2008-7 with attachment 4 LP0002, PSTN01, ADSL01, ID0002, IS6100, CNS14336, PLMN07, PLMN01, Taiwan NCC CAB Recognition PLMN08 Taiwan BSMI CAB Recognition CNS 13438 R-3083: Radiation 3 meter site Japan VCCI C-3421: Main Ports Conducted Interference Measurement T-1597: Telecommunication Ports Conducted Interference Measurement EMC: AS/NZS CISPR 11, AS/NZS CISPR 14.1, AS/NZS CISPR22, AS/NZS 61000.6.3, AS/NZS 61000.6.4 Radio communications: AS/NZS 4281, AS/NZS 4268, AS/NZS 4280.1, AS/NZS 4280.2, AS/NZS 4295, AS/NZS 4582, AS/NZS 4583, AS/NZS 4769.1, Australia CAB Recognition AS/NZS 4769.2, AS/NZS 4770, AS/NZS 4771 Telecommunications: AS/ACIF S002:05, AS/ACIF S003:06, AS/ACIF S004:06 AS/ACIF S006:01, AS/ACIF S016:01, AS/ACIF S031:01, AS/ACIF S038:01, AS/ACIF S040:01, AS/ACIF S041:05, AS/ACIF S043.2:06, AS/ACIF S60950.1 AS/ACIF S002, AS/ACIF S003, AS/ACIF S004, AS/ACIF S006, AS/ACIF Australia NATA Recognition S016,AS/ACIF S031, AS/ACIF S038, AS/ACIF S040, AS/ACIF S041, AS/ACIF S043.2 775 Montague Expressway, Milpitas, CA 95035, USA • Phone: (+1) 408 526 1188 • Facsimile (+1) 408 526 1088 Visit us at: www.siemic.com; Follow us at:


Document Created: 2018-05-25 10:52:48
Document Modified: 2018-05-25 10:52:48
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