VNP-ASAudioStream

Cochlear Implants User Manual AudioStream AW40784_1.0 (English US) 1 Table of Contents 1. Introduction ..............................................................................................................2 2. Intended use – Indications – Contraindications ........................................................3 Intended use ......................................................................................................................3 Indications..........................................................................................................................3 Contraindications ...............................................................................................................3 3. AudioStream ..............................................................................................................4 Using AudioStream for the first time .................................................................................4 How to use AudioStream ...................................................................................................5 4. General precautions and warnings ............................................................................6 5. Care and maintenance ..............................................................................................8 Maintenance ......................................................................................................................8 Disposal ..............................................................................................................................8 6. Troubleshooting ........................................................................................................9 7. Technical data ..........................................................................................................10 Regulatory statements......................................................................................................11 Symbols .............................................................................................................................11 Guidance and manufacturer’s declaration .......................................................................12 8. Appendices ..............................................................................................................14 Warranty ...........................................................................................................................14 Manufacturer address .......................................................................................................14 9. Contact MED-EL .......................................................................................................15 Introduction 2 1. Introduction This user manual provides information and instructions for the MED‑EL AudioStream (Ma070401), an optional battery pack cover for the SONNET and SONNET EAS series 1 , referred as SONNET series in this user manual. It includes descriptions of assembling instructions and instructions for proper care of the device. Please contact your healthcare provider or local MED‑EL representative with any additional questions you may have. NOTE: Please read the user manual of your audio processor carefully before reading this manual. Symbols used in this user manual Information indicating a hazardous situation that, if not avoided, could result in minor injury or inconvenience for the user and/or property damage. Information relevant for parents, guardians, or caregivers of children who use the system. ― 1 This covers SONNET/SONNET EAS and SONNET 2/SONNET 2 EAS audio processors. Intended use – Indications – Contraindications 3 2. Intended use – Indications – Contraindications Intended use AudioStream is an optional battery pack cover that can be used with the SONNET series audio processor to stream audio content from mobile devices (e.g. smartphone) to the SONNET series audio processor. Indications AudioStream is intended for users of any age, who have received a SONNET series audio processor. AudioStream is intended for use in typical everyday environments (home, office, outdoor, etc.) and suitable for everyday use during a user`s waking hours. Contraindications A user must not receive AudioStream if the individual is known to be intolerant of the materials used in AudioStream. AudioStream is not intended to be used in environments where radiofrequency (RF) transmissions are prohibited. AudioStream 4 3. AudioStream AudioStream wirelessly connects your audio processor with mobile devices (smartphone, tablet, etc.) to stream sound like a phone call or music directly to your ears without the need of intermediate accessories. For compatible Apple ® and Android™ 2 devices please visit our webpage at medel.com. AudioStream is an optional streaming gadget that is activated by slipping the cover over your battery pack option. Please refer to the applicable audio processor user manual for further information about how to lock the cover into place. Using AudioStream for the first time Assembling AudioStream To assemble AudioStream, proceed as follows: unlocked locked ①Switch off the audio processor by sliding off the battery pack cover you have been using (make sure that the lock on the cover is in the unlocked position). ②Assemble a compatible battery pack frame or rechargeable battery adapter to your audio processor if not already in use. A compatible battery pack frame or rechargeable battery adapter is indicated by this symbol . ③Make sure that the lock of the AudioStream cover is in the unlocked position. ④Slide AudioStream completely over the battery pack frame or rechargeable battery adapter to switch on the audio processor. PARENTAL GUIDANCE When the user is a young child, the battery pack cover lock must always be turned clockwise into the locked position once the cover has been moved completely over the frame or rechargeable battery adapter to prevent the child from disassembling the aud…

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FCC, Request for non-disclosure Date: 21-Nov-2018 RF_501, Issue 8 Page 1 of 1 Company Name: MED-EL Eletromedizinische Geräte G.m.b.H Address : Fürstenweg 77a City: 6020 Innsbruck Country: Austria To: Telefication B.V., Dept. FCC TCB Edisonstraat 12A 6902 PK ZEVENAAR The Netherlands Subject: Request for confidentiality FCC ID: VNP-AS Reference number: ###### Dear FCC TCB, 1. Long-Term Confidentiality Pursuant to 47 CFR Section 0.459(a) & (b), we hereby requests non-disclosure and confidential treatment of the following materials submitted in support of FCC certification application: Bill(s) of Material Block Diagrams Operational Description Schematic Diagrams Tune-up Procedure Above materials contain secrets, proprietary and technical information, which would customarily be guarded from competitors under 47 CFR, section 0.457(d)(2). Disclosure or publication or any portion of this company confidential material to other parties could cause substantial competitive harm and provide unjustified benefits for competitors. 2. Short-Term Confidentiality (STC) Pursuant to Public Notice DA 04-1705 of the Commission’s policy, in order to comply with the marketing regulations in 47 CFR §2.803 and the importation rules in 47 CFR §2.1204, a pplicant hereby requests Short-Term Confidential treatment of the following materials (See notes below): Internal Photos User’s Manual Test Set-up Photos External Photos Justification: These documents contain detailed system and equipment description and related information about the product, which Harman International Industries, Inc. considers to be proprietary. This information should never get into the possession of competitors, which would be harmful for our business Date: 10,26,2020 Name and signature of applicant: Abdellah Ahakki Notes: 1) A document or type of document can only have ONE type of confidentiality! 2) Short-Term confidentiality is in principle for 45 days from date of grant; it can be extended max 3 times (total time 180 days max.)! The planned date should stated in the RF731 application form. 3) FCC must be informed when marketing begins earlier. 4) Release takes place automatically thus extension must be requested in time. Telefication does not remind you of this! 5) Request for extension or for release must be received by Telefication at least 7 days before date of actual marketing or before expiration of the STC period FCC, Request for non-disclosure Date: 21-Nov-2018 RF_501, Issue 8 Page 1 of 1

External Photos Date: 06.Nov.2020 Company: MED-EL Model: AudioStream (Ma070401) FCC-ID: VNP-AS IC: 11986A-AS Dimensions: Height: 46 mm; Width: 15 mm; Depth: 8 mm

FCC / IC label and location Date: 06.Nov.2020 Company: MED-EL Model: AudioStream (Ma070401) FCC-ID: VNP-AS IC: 11986A-AS Label location: The FCC label and the IC label are located in the user manual only because the available space for labeling on the device itself is limited (about 8 mm x 13 mm). Labesl are located in the User Manual AW40784:

Internal Photos Date: 06.Nov.2020 Company: MED-EL Model: AudioStream (Ma070401) FCC-ID: VNP-AS IC: 11986A-AS

SAR Considerations Date: 11.Jan.2021 Company: MED-EL PMN: AudioStream HVIN: Ma070401 FCC-ID: VNP-AS IC: 11986A-AS Purpose This rationale demonstrates that the AudioStream is exempt from SAR Evaluation according to 47 CFR §2.1093, KDB 447498 D01 and RSS-102. 47 CRF § 2.1093 & KDB 447498 D01 Compliance The AudioStream is a portable device as defined in 47 CFR § 2.1093. According to 47 CFR $ 2.1093(c)(2) it is categorically excluded from routine environmental evaluation for RF exposure. KDB 447498 D01, section 4.3.1, defines the SAR Test Exclusion Threshold conditions. Requirements: Applicable exemption limits are defined in KDB 447498 D01: For 100 MHz to 6 GHz, and test separation distances ≤ 50 mm, the 1-g test exclusion threshold is determined by the following: 푚푎푥.푝표푤푒푟 표푓 푐ℎ푎푛푛푒푙,푖푛푐푙푢푑푖푛푔 푡푢푛푒−푢푝 푡표푙푒푟푎푛푐푒 (푚푊) 푚푖푛.푡푒푠푡 푠푒푝푎푟푎푡푖표푛 푑푖푠푡푎푛푐푒 (푚푚) ∗ √ 푓 ( 퐺퐻푧 ) ≤3.0 Maximum conducted output power of the RF channel requiring evaluation, adjusted for tune- up tolerance, and the minimum test separation distance shall be used. Calculation: Parameter Value in dB Value in dBm Value in mW Rounded to the nearest mW measured max. output power (e.i.r.p) 0.6 dBm Note 1 2.1 dBm 1.62 mW 2 mW max. tune-up tolerance 1.5 dB Parameter Value in mm Rounded to the nearest mm separation distance ≤ 5 Note 2 5 mm Parameter Value in GHz Value in GHz (highest) frequency 2.48 2.48 the formula above results in (rounded to one decimal place) 2 푚푊 5 푚푚 ∗ √ 2.48 퐺퐻푧=0.6≤3.0 Result: This calculation shows that the calculated value of 0.6 satisfies the SAR Test Exclusion Threshold condition of being smaller than the exemption limit of 3.0 and the AudioStream is therefore exempt from SAR Evaluation according to KDB 447498 D01 Seite 2 von 2 RSS-102 Compliance This section demonstrates that the AudioStream is exempt from routine SAR and RF exposure evaluation as the AudioStream complies with the requirements stated in RSS-102, 2.5.1 Requirements: • The applicable exemption limit according to RSS-102, 2.5.1 is as follows: Frequency (MHz) Exemption Limits (mW) for the output power At separation distance of ≤ 5 mm 2450 4 mW • This exemption limit can be used for devices that operate at a distance of equal or less than 20 cm from the radiating element to the user • The output power shall be the higher of the maximum conducted or equivalent isotropocally radiated power (e.i.r.p) source-based, time-averaged output power and adjusted for tune-up tolerance Calculation: The calculation is done with the following values: Parameter Value in dB Value in dBm Value in mW Measured max. output power (e.i.r.p) 0.6 dBm 2.1 dBm 1.62 mW max. tune-up tolerance 1.5 dB Result: The calculation shows that the calculated value of 1.62 mW is below the exemption limit of 4.0 mW and the AudioStream is therefore exempt from SAR Evaluation according to RSS-102. Conclusion It was demonstrated that the AudioStream is exempt from SAR Evaluation and complies with the SAR Test Exclusion Threshold stated in KDB 447498 D01 and RSS-102 Note 1: A duty cycle of 100% is assumed, thus the measured EIRP is equivalent to the average EIRP Note 2: According to KDB 447498 D01, 4.3.1, for separation distances ≤ 5 mm, a test distance of 5 mm shall be used

Test Laboratory: 7layers GmbH Borsigstrasse 11 40880 Ratingen Germany Note: The following test results relate only to the devices specified in this document. This report shall not be reproduced in parts without the written approval of the test laboratory. 7layers GmbH Geschäftsführer/ Borsigstraße 11 Managing Directors: Registergericht/registered: a Bureau Veritas 40880 Ratingen, Germany Frank Spiller Düsseldorf HRB 75554 Group Company T +49 (0) 2102 749 0 Bernhard Retka USt-Id.-Nr./VAT-No. DE203159652 F +49 (0) 2102 749 350 Alexandre Norré-Oudard Steuer-Nr./TAX-No. 147/5869/0385 www.7layers.com Commerzbank AG Account No. 303 016 000 Bank Code 300 400 00 IBAN DE81 3004 0000 0303 0160 00 Swift Code COBADEFF FCC Measurement/Technical Report on AudioStream FCC ID: VNP-AS IC: 11986A-AS Test Report Reference: MDE_MEDEL_1901_FCC_01 TEST REPORT REFERENCE: MDE_MEDEL_1901_FCC_01 Page 2 of 62 Table of Contents 1 Applied Standards and Test Summary 3 1.1 Applied Standards 3 1.2 FCC-IC Correlation Table 4 1.3 Measurement Summary 5 2 Revision History / Signatures 8 3 Administrative Data 9 3.1 Testing Laboratory 9 3.2 Project Data 9 3.3 Applicant Data 9 3.4 Manufacturer Data 10 4 Test object Data 11 4.1 General EUT Description 11 4.2 EUT Main components 11 4.3 Ancillary Equipment 12 4.4 Auxiliary Equipment 12 4.5 EUT Setups 12 4.6 Operating Modes / Test Channels 12 4.7 Product labelling 13 5 Test Results 15 5.1 Occupied Bandwidth (6 dB) 15 5.2 Occupied Bandwidth (99%) 18 5.3 Peak Power Output 21 5.4 Spurious RF Conducted Emissions 25 5.5 Transmitter Spurious Radiated Emissions 28 5.6 Band Edge Compliance Conducted 37 5.7 Band Edge Compliance Radiated 42 5.8 Power Density 45 6 Test Equipment 49 7 Antenna Factors, Cable Loss and Sample Calculations 54 7.1 LISN R&S ESH3-Z5 (150 kHz – 30 MHz) 54 7.2 Antenna R&S HFH2-Z2 (9 kHz – 30 MHz) 55 7.3 Antenna R&S HL562 (30 MHz – 1 GHz) 56 7.4 Antenna R&S HF907 (1 GHz – 18 GHz) 57 7.5 Antenna EMCO 3160-09 (18 GHz – 26.5 GHz) 58 7.6 Antenna EMCO 3160-10 (26.5 GHz – 40 GHz) 59 8 Setup Drawings 60 9 Measurement Uncertainties 61 10 Photo Report 62 TEST REPORT REFERENCE: MDE_MEDEL_1901_FCC_01 Page 3 of 62 1 APPLIED STANDARDS AND TEST SUMMARY 1.1 APPLIED STANDARDS Type of Authorization Certification for an Intentional Radiator. Applicable FCC Rules Prepared in accordance with the requirements of FCC Rules and Regulations as listed in 47 CFR Ch.1 Parts 2 and 15 (10-1-18 Edition). The following subparts are applicable to the results in this test report. Part 2, Subpart J - Equipment Authorization Procedures, Certification Part 15, Subpart C – Intentional Radiators § 15.201 Equipment authorization requirement § 15.207 Conducted limits § 15.209 Radiated emission limits; general requirements § 15.247 Operation within the bands 902-928 MHz, 2400-2483.5 MHz Note: The tests were selected and performed with reference to the FCC Public Notice “Guidance for Compliance Measurements on Digital Transmission System, Frequency Hopping Spread Spectrum System, and Hybrid System Devices Operating under Section 15.247 of the FCC Rules, 558074 D01 15.247 Meas Guidance v05r02, 2019-04-02”. ANSI C63.10–2013 is applied. TEST REPORT REFERENCE: MDE_MEDEL_1901_FCC_01 Page 4 of 62 1.2 FCC-IC CORRELATION TABLE Correlation of measurement requirements for DTS (e.g. WLAN 2.4 GHz, BT LE) equipment from FCC and IC DTS equipment Measurement FCC reference IC reference Conducted emissions on AC Mains § 15.207 RSS-Gen Issue 5: 8.8 Occupied bandwidth § 15.247 (a) (2) RSS-247 Issue 2: 5.2 (a) Peak conducted output power § 15.247 (b) (3), (4) RSS-247 Issue 2: 5.4 (d) Transmitter spurious RF conducted emissions § 15.247 (d) RSS-Gen Issue 5: 6.13 / 8.9/8.10; RSS-247 Issue 2: 5.5 Transmitter spurious radiated emissions § 15.247 (d); § 15.209 (a) RSS-Gen Issue 5: 6.13 / 8.9/8.10; RSS-247 Issue 2: 5.5 Band edge compliance § 15.247 (d) RSS-247 Issue 2: 5.5 Power density § 15.247 (e) RSS-247 Issue 2: 5.2 (b) Antenna requirement § 15.203 / 15.204 RSS-Gen Issue 5: 8.3 Receiver spurious emissions – – TEST REPORT REFERENCE: MDE_MEDEL_1901_FCC_01 Page 5 of 62 1.3 MEASUREMENT SUMMARY 47 CFR CHAPTER I FCC PART 15 Subpart C §15.247 § 15.247 (a) (2) Occupied Bandwidth (6 dB) The measurement was performed according to ANSI C63.10 Final Result OP-Mode Radio Technology, Operating Frequency Setup Date FCC IC Bluetooth LE 1 Mbps, high S01_BA01 2020-07-08 Passed Passed Bluetooth LE 1 Mbps, low S01_BA01 2020-07-08 Passed Passed Bluetooth LE 1 Mbps, mid S01_BA01 2020-07-08 Passed Passed Bluetooth LE 2 Mbps, high S01_BA01 2020-07-08 Passed Passed Bluetooth LE 2 Mbps, low S01_BA01 2020-07-08 Passed Passed Bluetooth LE 2 Mbps, mid S01_BA01 2020-07-08 Passed Passed 47 CFR CHAPTER I FCC PART 15 Subpart C §15.247 IC RSS-Gen & IC TRC-43; Ch. 6.7 & Ch. 8 Occupied Bandwidth (99%) The measurement was performed according to ANSI C63.10 Final Result OP-Mode Radio Technology, Operating Frequency Setup Date FCC IC Bluetooth LE 1 Mbps, high S01_BA01 2020-07-08 N/A Performed Bluetooth LE 1 Mbps, low S01_BA01 2020-07-08 N/A Performed Bluetooth LE 1 Mbps, mid S01_BA01 2020-07-08 N/A Performed Bluetooth LE 2 Mbps, high S01_BA01 2020-07-08 N/A Performed Bluetooth LE 2 Mbps, low S01_BA01 2020-07-08 N/A Performed Bluetooth LE 2 Mbps, mid S01_BA01 2020-07-08 N/A Performed 47 CFR CHAPTER I FCC PART 15 Subpart C §15.247 § 15.247 (b) (3) Peak Power Output The measurement was performed according to ANSI C63.10 Final Result OP-Mode Radio Technology, Operating Frequency, Measurement method Setup Date FCC IC Bluetooth LE 1 Mbps, high, conducted S01_BA01 2020-07-08 Passed Passed Bluetooth LE 1 Mbps, low, conducted S01_BA01 2020-07-08 Passed Passed Bluetooth LE 1 Mbps, mid, conducted S01_BA01 2020-07-08 Passed Passed Bluetooth LE 2 Mbps, high, conducted S01_BA01 2020-07-08 Passed Passed Bluetooth LE 2 Mbps, low, conducted S01_BA01 2020-07-08 Passed Passed Bluetooth LE 2 Mbps, mid, conducted S01_BA01 2020-07-08 Passed Passed TEST REPORT REFERENCE: MDE_MEDEL_1901_FCC_0…

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Test Laboratory: 7layers GmbH Borsigstrasse 11 40880 Ratingen Germany Note: The following test results relate only to the devices specified in this document. This report shall not be reproduced in parts without the written approval of the test laboratory. 7layers GmbH Geschäftsführer/ Borsigstraße 11 Managing Directors: Registergericht/registered: a Bureau Veritas 40880 Ratingen, Germany Frank Spiller Düsseldorf HRB 75554 Group Company T +49 (0) 2102 749 0 Bernhard Retka USt-Id.-Nr./VAT-No. DE203159652 F +49 (0) 2102 749 350 Alexandre Norré-Oudard Steuer-Nr./TAX-No. 147/5869/0385 www.7layers.com Commerzbank AG Account No. 303 016 000 Bank Code 300 400 00 IBAN DE81 3004 0000 0303 0160 00 Swift Code COBADEFF Photo Report on AudioStream Report Reference: MDE_MEDEL_1901_FCC_Photo_Setups Test report Reference: MDE_MEDEL_1901_FCC_Photo_Setups Page 2 of 6 Photo 1: Test setup for radiated measurements (stand alone , semi-anechoic chamber 30 MHz – 1 GHz; unintentional radiator §15.109, ANSI C63.4) Test report Reference: MDE_MEDEL_1901_FCC_Photo_Setups Page 3 of 6 Photo 2: Test setup for radiated measurements (stand alone setup, semi-anechoic chamber above 1 GHz ; unintentional radiator §15.109, ANSI C63.4) Test report Reference: MDE_MEDEL_1901_FCC_Photo_Setups Page 4 of 6 Photo 3: Test setup for radiated measurements (stand alone setup, 30 MHz - 1 GHz; FCC 15c247) Test report Reference: MDE_MEDEL_1901_FCC_Photo_Setups Page 5 of 6 Photo 4: Test setup for radiated measurements (stand alone setup, 1 GHz – 24 GHz; FCC 15c247) Test report Reference: MDE_MEDEL_1901_FCC_Photo_Setups Page 6 of 6 Photo 5: Test setup for radiated measurements, detailed view (stand alone setup, 1 GHz – 24 GHz; FCC 15c247)