Test Report

FCC ID: QZ3OSIA2

Test Report

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FCCID_4438690

DEKRA Testing and Certification, S.A.U. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España C.I.F. A29 507 456 ISED LISTED Test report No: REGISTRATION NUMBER 4621A-2 NIE: 57186RRF.005 Test report USA FCC Part 15.209 CANADA RSS-Gen Issue 5 Identification of item tested General Medical Devices (Bone anchored sound processor). Trademark Cochlear Model and /or type reference Osia 2 Sound Processor Other identification of the product FCC ID: QZ3OSIA2 IC: 8039C-OSIA2 HW Version: EP4 SW Version: Osia2-NPC.0.8.5 Features Bluetooth LE, Proprietary protocol 2.4 GHz ISM band, SRD 5 MHz. Applicant COCHLEAR BONE ANCHORED SOLUTIONS AB Konstruktionsvägen 14, 43533 Mölnlycke, SWEDEN Test method requested, standard USA FCC Part 15.209 (10–1–17 Edition): Radiated emission limits, general requirements. CANADA RSS-Gen Issue 5 (April 2018). General Requirements for Compliance of Radio Apparatus. ANSI C63.10-2013: American National Standard for Testing Unlicensed Wireless Devices. Summary IN COMPLIANCE Approved by (name / position & signature) A. Llamas Firmado digitalmente RF Lab. Manager por ALEJANDRO LLAMAS RODRIGUEZ Fecha: 2019.02.21 17:27:25 +01'00' Date of issue 2019-02-21 Report template No FDT08_21 Report No: (NIE) 57186RRF.005 2019-02-21

DEKRA Testing and Certification, S.A.U. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España C.I.F. A29 507 456 Index Competences and guarantees ......................................................................................................................3 General conditions .........................................................................................................................................3 Uncertainty.....................................................................................................................................................3 Usage of samples ..........................................................................................................................................4 Test sample description .................................................................................................................................4 Identification of the client ...............................................................................................................................4 Testing period and place ...............................................................................................................................5 Document history ...........................................................................................................................................6 Environmental conditions ..............................................................................................................................6 Remarks and comments ................................................................................................................................7 Testing verdicts ..............................................................................................................................................8 Summary .......................................................................................................................................................8 Appendix A: Test results ................................................................................................................................9 Report No: (NIE) 57186RRF.005 Page 2 of 16 2019-02-21

DEKRA Testing and Certification, S.A.U. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España C.I.F. A29 507 456 Competences and guarantees DEKRA Testing and Certification S.A.U. is a testing laboratory accredited by the National Accreditation Body (ENAC -Entidad Nacional de Acreditación), to perform the tests indicated in the Certificate No. 51/LE 147. DEKRA Testing and Certification S.A.U. is a FCC-recognized accredited testing laboratory with appropriate scope of accreditation that include testing performed in this test report. DEKRA Testing and Certification S.A.U. is a laboratory with a measurement site in compliance with the requirements of RSS 212, Issue 1 (Provisional) and has been added to the list of filed sites of the Canadian Certification and Engineering Bureau. Reference File Number: ISED 4621A-2. In order to assure the traceability to other national and international laboratories, DEKRA Testing and Certification S.A.U. has a calibration and maintenance program for its measurement equipment. DEKRA Testing and Certification S.A.U. guarantees the reliability of the data presented in this report, which is the result of the measurements and the tests performed to the item under test on the date and under the conditions stated on the report and, it is based on the knowledge and technical facilities available at DEKRA Testing and Certification S.A.U. at the time of performance of the test. DEKRA Testing and Certification S.A.U. is liable to the client for the maintenance of the confidentiality of all information related to the item under test and the results of the test. The results presented in this Test Report apply only to the particular item under test established in this document. IMPORTANT: No parts of this report may be reproduced or quoted out of context, in any form or by any means, except in full, without the previous written permission of DEKRA Testing and Certification S.A.U. General conditions 1. This report is only referred to the item that has undergone the test. 2. This report does not constitute or imply on its own an approval of the product by the Certification Bodies or competent Authorities. 3. This document is only valid if complete; no partial reproduction can be made without previous written permission of DEKRA Testing and Certification S.A.U. 4. This test report cannot be used partially or in full for publicity and/or promotional purposes without previous written permission of DEKRA Testing and Certification S.A.U. and the Accreditation Bodies. Uncertainty Uncertainty (factor k=2) was calculated according to the DEKRA Testing and Certification S.A.U. internal document PODT000. Data provided by the client The Cochlear Osia System uses bone conduction to transmit sounds to the cochlear (inner ear) with the purpose of enhancing hearing. The Osia 2 Sound Processor is intended to be used as a part of the Cochlear Osia System to pick up surrounding sound and transfer it to the implant through a digital inductive link. DEKRA Testing and Certification S.A.U. declines any responsibility with respect to the information provided by the client and that may affect the validity of results. Report No: (NIE) 57186RRF.005 Page 3 of 16 2019-02-21

DEKRA Testing and Certification, S.A.U. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España C.I.F. A29 507 456 Usage of samples Samples undergoing test have been selected by: The client. - Sample S/01 is composed of the following elements: Control Nº Description Model Serial Nº Reception 57186B/001 General Medical Devices Osia 2 Sound 1170020010597 2018/11/19 (Bone anchored sound Processor processor) 57186B/009 Water tank -- -- 2018/11/19 57186B/015 OSI100 implant -- -- 2018/11/19 Sample S/01 has undergone the following test(s): All RADIATED tests indicated in Appendix A. - Sample S/02 is composed of the following elements: Control Nº Description Model Serial Nº Reception 57186B/014 General Medical Devices Osia 2 Sound 1170020012560 2018/11/19 (Bone anchored sound Processor processor) 57186B/005 Speedlink -- -- 2018/11/19 57187B/006 USB cable -- -- 2018/11/19 57187B/007 Programming cable -- -- 2018/11/19 Sample S/02 has undergone the following test(s): All CONDUCTED tests indicated in Appendix A. Test sample description Ports………………………………. : Cable Port name and Specified Attached Shielded Coupled description max during test to length [m] patient(3) Antenna (for 2.4GHz ISM band) Coil (for 5 MHz inductive link) Supplementary information to the ports………………………………. : Rated power supply .................... : Reference poles Voltage and Frequency L1 L2 L3 N PE DC:1.45 V Report No: (NIE) 57186RRF.005 Page 4 of 16 2019-02-21

DEKRA Testing and Certification, S.A.U. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España C.I.F. A29 507 456 Rated Power ............................... : Clock frequencies ....................... : 16 MHz, 40MHz Other parameters ........................ : Software version ......................... : Drop 4.1, Osia2-NPC.0.8.5 Hardware version ........................ : EP4 Dimensions in cm (W x H x D) .... : Mounting position ........................ : Other: Body-worn equipment Modules/parts ............................. : Module/parts of test item Type Manufacturer Accessories (not part of the test Description Type Manufacturer item) ............................................ : Bone conduction implant OSI100 Cochlear MiniMic SM-2P Cochlear Skull simulator TU 1000 Cochlear Documents as provided by the Description File name Issue date applicant ...................................... : (3) Only for Medical Equipment Identification of the client COCHLEAR BONE ANCHORED SOLUTIONS AB Konstruktionsvägen 14, 43533 Mölnlycke, SWEDEN Testing period and place Test Location DEKRA Testing and Certification S.A.U. Date (start) 2018-11-20 Date (finish) 2019-01-18 Report No: (NIE) 57186RRF.005 Page 5 of 16 2019-02-21

DEKRA Testing and Certification, S.A.U. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España C.I.F. A29 507 456 Document history Report number Date Description 57186RRF.005 2019-02-21 First release Environmental conditions In the control chamber, the following limits were not exceeded during the test: Min. = 15 ºC Temperature Max. = 35 ºC Min. = 20 % Relative humidity Max. = 75 % Shielding effectiveness > 100 dB Electric insulation > 10 k Reference resistance to earth <1 In the semianechoic chamber, the following limits were not exceeded during the test. Min. = 15 ºC Temperature Max. = 35 ºC Min. = 20 % Relative humidity Max. = 75 % Min. = 860 mbar Air pressure Max. = 1060 mbar Shielding effectiveness > 100 dB Electric insulation > 10 k Reference resistance to earth <1 < ±4 dB at 10 m distance between item under test Normal site attenuation (NSA) and receiver antenna, (30 MHz to 1000 MHz) More than 75% of illuminated surface is between 0 Field homogeneity and 6 dB (26 MHz to 1000 MHz). In the chamber for conducted measurements, the following limits were not exceeded during the test: Temperature Min. = 15 ºC Max. = 35 ºC Relative humidity Min. = 20 % Max. = 35 % Air pressure Min. = 860 mbar Max. = 1060 mbar Shielding effectiveness > 100 dB Electric insulation > 10 k Reference resistance to earth <1 Report No: (NIE) 57186RRF.005 Page 6 of 16 2019-02-21

DEKRA Testing and Certification, S.A.U. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España C.I.F. A29 507 456 Remarks and comments The tests have been performed by the technical personnel: Juan Carlos Fuentes, Carolina Postigo, Francisco José Alcaide. Used instrumentation: Conducted Measurements: Last Calibration Due Calibration 1. Signal and spectrum analyzer R&S FSV40 2017/07 2019/07 2. DC power supply R&S NGPE 40/40 2018/02 2021/02 Radiated Measurements: Last Calibration Due Calibration 1. Semianechoic Absorber Lined Chamber ETS N.A. N.A. LINDGREN FACT 3 200 STP 2. Shielded Room ETS LINDGREN S101 N.A. N.A. 3. EMI Receiver ROHDE AND SCHWARZ ESU40 2018/06 2020/06 4. Active Loop Antenna Hewlett Packard 11966A 2018/06 2020/06 5. Biconical/Log Antenna ETS LINDGREN 3142E 2017/04 2020/04 6. RF Pre-amplifier, 38 dB, 30 MHz-6 GHz BONN 2018/07 2019/07 ELEKTRONIK BLNA 0360-01N Report No: (NIE) 57186RRF.005 Page 7 of 16 2019-02-21

DEKRA Testing and Certification, S.A.U. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España C.I.F. A29 507 456 Testing verdicts Not applicable: N/A Pass: P Fail: F Not measured: N/M Summary 1. SRD 5 MHz FCC PART 15.209 / RSS-Gen PARAGRAPH Requirement – Test case Verdict Remark Occupied bandwidth P 15.209 Subclause (a) / RSS-Gen Clause 8.9. Transmitter emission limits P Supplementary information and remarks: None. Report No: (NIE) 57186RRF.005 Page 8 of 16 2019-02-21

DEKRA Testing and Certification, S.A.U. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España C.I.F. A29 507 456 Appendix A: Test results Report No: (NIE) 57186RRF.005 Page 9 of 16 2019-02-21

DEKRA Testing and Certification, S.A.U. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España C.I.F. A29 507 456 INDEX TEST CONDITIONS ...............................................................................................................................................11 Occupied Bandwidth ...............................................................................................................................................13 Section 15.209 Subclause (a) / RSS-Gen Clause 8.9. Transmitter emission limits ...............................................14 Report No: (NIE) 57186RRF.005 Page 10 of 16 2019-02-21

DEKRA Testing and Certification, S.A.U. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España C.I.F. A29 507 456 TEST CONDITIONS POWER SUPPLY (V): Vnominal: 1.45 Vdc Type of power supply: DC voltage from battery. Type of antenna: Integral antenna (inductive coil). TEST FREQUENCIES: Nominal Operating Frequency: 5 MHz CONDUCTED MEASUREMENTS The equipment under test EUT was set up in a shielded room and it is connected to the spectrum analyzer through a RF cable and a coupling device. RADIATED MEASUREMENTS All radiated tests were performed in a semi-anechoic chamber. The measurement antenna is situated at a distance of 3 m (Loop antenna for the range between 9 kHz to 30 MHz and Bilog antenna for 30 MHz to 60 MHz ). For radiated emissions in the range 9 kHz to 30 MHz that is performed at a distance closer than the specified distance, an inverse proportionality factor of 40 dB per decade is used to normalize the measured data for determining compliance. The equipment under test was set up on a non-conductive platform above the ground plane and the situation and orientation was varied to find the maximum radiated emission. It was also rotated 360º and the antenna height was varied from 1 to 4 meters to find the maximum radiated emission. In the range between 9 kHz and 30 MHz the measurements were made in the three different orientation planes of the loop antenna to determine the maximum received field. Measurements above 30 MHz up to 60 MHz were made in both horizontal and vertical planes of polarization. The test was performed with the equipment transmitting first with only the 5 MHz radio and repeated with the Bluetooth Low Energy 2.4 GHz radio and then the Proprietary protocol 2.4 GHz radio transmitting simultaneously to check the impact of the co-location of the other radio interfaces. The results and plots below show the worst results obtained. Report No: (NIE) 57186RRF.005 Page 11 of 16 2019-02-21

DEKRA Testing and Certification, S.A.U. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España C.I.F. A29 507 456 Radiated measurements setup f < 30 MHz: Radiated measurements setup f > 30 MHz up to 60 MHz: Report No: (NIE) 57186RRF.005 Page 12 of 16 2019-02-21

DEKRA Testing and Certification, S.A.U. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España C.I.F. A29 507 456 Occupied Bandwidth RESULTS: 99% bandwidth (MHz) 3.89 Measurement uncertainty (kHz) <±5.51 Report No: (NIE) 57186RRF.005 Page 13 of 16 2019-02-21

DEKRA Testing and Certification, S.A.U. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España C.I.F. A29 507 456 Section 15.209 Subclause (a) / RSS-Gen Clause 8.9. Transmitter emission limits SPECIFICATION: Except as provided elsewhere in this subpart, the emissions from an intentional radiator shall not exceed the field strength levels specified in the following table (see §15.205(c) / RSS-Gen): Frequency Range Field strength (µV/m) Field strength Measurement (MHz) (dBµV/m) distance (m) 0.009-0.490 2400/F(kHz) - 300 0.490-1.705 24000/F(kHz) - 30 1.705 - 30.0 30 29.54 30 30 - 88 100 40 3 88 - 216 150 43.5 3 216 - 960 200 46 3 Above 960 500 54 3 RESULTS: All tests were performed in a semi-anechoic chamber at a distance of 3 m. The spectrum was inspected from 9 kHz to 60 MHz searching for spurious signals. The field strength is calculated by adding correction factor to the measured level from the spectrum analyser. This correction factor includes antenna factor and cable loss. Frequency range 9 kHz - 30 MHz No spurious signals were found at less than 20 dB respect to the limit. Verdict: PASS Frequency range 30 - 60 MHz Spurious frequency Detector Emission Level Polarization Measurement (MHz) (dBµV/m) Uncertainty (dB) 30.5615 Quasi peak 28.8 V <± 3.88 Verdict: PASS Report No: (NIE) 57186RRF.005 Page 14 of 16 2019-02-21

DEKRA Testing and Certification, S.A.U. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España C.I.F. A29 507 456 FREQUENCY RANGE 9 kHz-30 MHz Resolution bandwidth: 200 Hz for 9 kHz ≤ f ≤ 150 kHz 9 kHz for 150 kHz ≤ f ≤ 30 MHz Note: The scan is performed with a peak detector. The limits shown in the above plot are extrapolated to 3 meters. Report No: (NIE) 57186RRF.005 Page 15 of 16 2019-02-21

DEKRA Testing and Certification, S.A.U. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España C.I.F. A29 507 456 FREQUENCY RANGE 30 - 60 MHz Note: The scan is performed with a peak detector. Report No: (NIE) 57186RRF.005 Page 16 of 16 2019-02-21


Document Created: 2019-02-21 17:27:25
Document Modified: 2019-02-21 17:27:25
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