VNP-FTFine Tuner for speech processor

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28.09.2007 From: Generic Office of Engineering Technology [mailto:[email protected]] Sent: Friday, April 20, 2007 2:21 PM To: Bernhard Stöbich Subject: Response to Inquiry to FCC (Tracking Number 375119) Inquiry: Ladies and gentlemen, we are a manufacturer of special hearing aids. These hearing aids are equipped with a battery powered handheld remote control that allows the user to vary certain parameters of the hearing aid (e.g volume). The remote control transmits its commands to the hearing aid via a wireless inductive link with a carrier frequency (= fundamental frequency) of 9.07kHz. Having reviewed the FCC part 15 rules we are of the opinion that verification might be the appropriate authorization procedure for this type of device (acc. to 15.201, devices operating below 490kHz), however, in order to be absolutely sure, we are posting this inquiry. We assume that for verification testing the most relevant requirements are: - All emissions from 9kHz to 100kHz (i.e. up to tenth harmonic of the fundamental frequency acc. to 15.33a1) must be at least 40dB below the limits given in the table in 15.209a. - The level of unwanted emissions must always be below the level of the fundamental emission (acc. to 15.209c). - As the remote control incorporates a class B digital device with an internal clock frequency of 4 MHz (unintentional radiator), the spurious emissions up to 1000 MHz must be measured and the limits acc. to 15.109a apply (acc. to 15.209f). Are our above assumptions concerning verification testing correct? Thank you very much for your help in advance. Response: Based on your description that the handheld remote control is only a transmitter and the digital logic is only used to control and operate the transmitter then verifying this as a digital device under part 15B is not permitted. Section 15.201 does permit verification if the intentional operating frequency is below 490 KHz and all emissions are 40 dB below the limits in 15.209. If you are in situation were you can not meet the 15.209 verification limits because of the digital logic, then your only choice is to certify the transmitter. Do not reply to this message. Please select the Reply to an Inquiry Response link from the OET Inquiry System to add any additional information pertaining to this inquiry. Seite 2 von 2 28.09.2007

mikes-testingpartners gmbh File No. T30390-07-00AA, page 5 of 20 Ohmstrasse 2-4 x 94342 Strasskirchen Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.1 3 EQUIPMENT UNDER TEST 3.1 Photo documentation of the EuT External photos

mikes-testingpartners gmbh File No. T30390-07-00AA, page 6 of 20 Ohmstrasse 2-4 x 94342 Strasskirchen Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.1 Internal Photos PCB – Front side mikes-testingpartners gmbh File No. T30390-07-00AA, page 7 of 20 Ohmstrasse 2-4 x 94342 Strasskirchen Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.1 Internal Photos PCB – Rear side mikes-testingpartners gmbh File No. T30390-07-00AA, page 8 of 20 Ohmstrasse 2-4 x 94342 Strasskirchen Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.1 Internal photo Rear side Internal photo Antenna mikes-testingpartners gmbh File No. T30390-07-00AA, page 9 of 20 Ohmstrasse 2-4 x 94342 Strasskirchen Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.1 Internal photo Battery case

mikes-testingpartners gmbh File No. T30390-07-00AA, page 1 of 20 Ohmstrasse 2-4 x 94342 Strasskirchen Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.1 EMI -- T E S T R E P O R T Test Report No. : T30390-07-00AA 20. September 2007 ______________________________________________________________________________________________ Date of issue Type / Model Name : Fine Tuner Product Description : Remote control for speech processor for cochlear implant Applicant : MED-EL Elektromedizinische Geräte GmbH Address : Fürstenweg 77a A-6020 Innsbruck, Austria Manufacturer : MED-EL Elektromedizinische Geräte GmbH Address : Fürstenweg 77a A-6020 Innsbruck, Austria Licence holder : MED-EL Elektromedizinische Geräte GmbH Address : Fürstenweg 77a A-6020 Innsbruck, Austria Test Result according to the standards listed in clause 1 test standards: POSITIVE The test report merely corresponds to the test sample. It is not permitted to copy extracts of these test results without the written permission of the test DAT-P-207/05-00 laboratory. mikes-testingpartners gmbh File No. T30390-07-00AA, page 2 of 20 Ohmstrasse 2-4 x 94342 Strasskirchen Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.1 Contents 1 TEST STANDARDS 3 2 SUMMARY 4 3 EQUIPMENT UNDER TEST 5 3.1 PHOTO DOCUMENTATION OF THE EUT 5 3.2 POWER SUPPLY SYSTEM UTILISED 10 3.3 SHORT DESCRIPTION OF THE EQUIPMENT UNDER TEST (EUT) 10 4 TEST ENVIRONMENT 11 4.1 ADDRESS OF THE TEST LABORATORY 11 4.2 ENVIRONMENTAL CONDITIONS 11 4.3 STATEMENT OF THE MEASUREMENT UNCERTAINTY 11 4.4 MEASUREMENT PROTOCOL FOR FCC, VCCI AND AUSTEL 11 5 TEST CONDITIONS AND RESULTS 13 5.1 CONDUCTED EMISSIONS 13 5.2 FIELD STRENGTH OF THE FUNDAMENTAL WAVE 14 5.3 SPURIOUS EMISSIONS (MAGNECTIC FIELD) 9 KHZ – 30 MHZ 16 5.4 RADIATED EMISSIONS (ELECTRIC FIELD) 30 MHZ – 1 GHZ 18 6 USED TEST EQUIPMENT AND ACCESSORIES 20 mikes-testingpartners gmbh File No. T30390-07-00AA, page 3 of 20 Ohmstrasse 2-4 x 94342 Strasskirchen Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.1 1 TEST STANDARDS The tests were performed according to following standards: FCC Rules and Regulations Part 15 Subpart C- Intentional Radiators (May 04, 2007) Part 15, Subpart C, Section 15.209 Radiated emissions, general requirements mikes-testingpartners gmbh File No. T30390-07-00AA, page 4 of 20 Ohmstrasse 2-4 x 94342 Strasskirchen Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.1 2 SUMMARY GENERAL REMARKS: None. FINAL ASSESSMENT: The equipment under test fulfills the EMI requirements cited in clause 1 test standards. Date of receipt of test sample : acc. to storage records Testing commenced on : 19. September 2007 Testing concluded on : 19. September 2007 Checked by: Tested by: Klaus Gegenfurtner Dipl.-Ing.(FH) Manager: Radio Group Anton Altmann Dipl.-Ing. (FH) mikes-testingpartners gmbh File No. T30390-07-00AA, page 5 of 20 Ohmstrasse 2-4 x 94342 Strasskirchen Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.1 3 EQUIPMENT UNDER TEST 3.1 Photo documentation of the EuT External photos mikes-testingpartners gmbh File No. T30390-07-00AA, page 6 of 20 Ohmstrasse 2-4 x 94342 Strasskirchen Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.1 Internal Photos PCB – Front side mikes-testingpartners gmbh File No. T30390-07-00AA, page 7 of 20 Ohmstrasse 2-4 x 94342 Strasskirchen Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.1 Internal Photos PCB – Rear side mikes-testingpartners gmbh File No. T30390-07-00AA, page 8 of 20 Ohmstrasse 2-4 x 94342 Strasskirchen Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.1 Internal photo Rear side Internal photo Antenna mikes-testingpartners gmbh File No. T30390-07-00AA, page 9 of 20 Ohmstrasse 2-4 x 94342 Strasskirchen Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.1 Internal photo Battery case mikes-testingpartners gmbh File No. T30390-07-00AA, page 10 of 20 Ohmstrasse 2-4 x 94342 Strasskirchen Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.1 3.2 Power supply system utilised Power supply voltage : 3V DC 3.3 Short description of the Equipment under Test (EuT) The remote control (market name: „Fine Tuner“) is an accessory to a speech processor, which is a medical device similar to a hearing aid. The remote control allows the user to modify various parameters as e.g. volume or microphone sensitivity of the speech processor. The working frequency is at 9.07 kHz. Number of tested samples: 1 Serial number: 02670 EuT operation mode: The equipment under test was operated during the measurement under the following conditions: - Tx continuous wave - TX modulated EuT configuration: (The CDF filled by the applicant can be viewed at the test laboratory.) The following peripheral devices and interface cables were connected during the measurements: - Model : - Model : - Model : - Model : - Model : - Model : mikes-testingpartners gmbh File No. T30390-07-00AA, page 11 of 20 Ohmstrasse 2-4 x 94342 Strasskirchen Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.1 4 TEST ENVIRONMENT 4.1 Address of the test laboratory mikes-testingpartners gmbh Ohmstrasse 2-4 94342 Strasskirchen Germany 4.2 Environmental conditions During the measurement the environmental conditions were within the listed ranges: Temperature: 15-35 ° C Humidity: 30-60 % Atmospheric pressure: 86-106 kPa 4.3 Statement of the measurement uncertainty The data and results referenced in this document are true and accurate. The reader is cautioned that there may be errors within the calibration limits of the equipment and facilities. The measurement uncertainty was calculated for all measurements listed in this test report acc. to CISPR 16-4-2 /11.2003 „Uncertainties, statistics and limit modelling – Uncertainty in EMC measurements“ and is documented in the quality system acc. to DIN EN ISO/IEC 17025. Furthermore, component and process variability of devices similar to that tested may result in additional deviation. The manufacturer has the sole responsibility of …

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mikes-testingpartners gmbh File No. T30390-07-00AA, page 14 of 20 Ohmstrasse 2-4 x 94342 Strasskirchen Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.1 5.2 Field strength of the fundamental wave For test instruments and accessories used see section 6 Part CPR 1. 5.2.1 Description of the test location Test location: OATS1 Test distance: 3 metres 5.2.2 Photo documentation of the test set-up mikes-testingpartners gmbh File No. T30390-07-00AA, page 16 of 20 Ohmstrasse 2-4 x 94342 Strasskirchen Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.1 5.3 Spurious emissions (Magnectic field) 9 kHz – 30 MHz For test instruments and accessories used see section 6 Part SER 1. 5.3.1 Description of the test location Test location: OATS1 Test distance: 3 metres 5.3.2 Photo documentation of the test set-up 5.3.3 Description of Measurement The spurious emissions from the EuT will be measured on an open area test site in the frequency range of 9 kHz to 30 MHz using a tuned receiver and a shielded loop antenna. The antenna was positioned 3, 10 or 30 meters horizontally from the EuT. Measurements have been made in all three orthogonal axes and the shielded loop antenna was rotated to locate the maximum of the emissions. In the case where larger measuring distances are required the results will extrapolated based on the values measured on the closer distances according to Section 15.31 (f) (2) [2]. The final measurement will be performed with an EMI Receiver set to Quasi Peak detector except for the frequency bands 9 kHz to 90 kHz and 110 to 490 kHz where an average detector will be used according to Section 15.209 (d) [2]. The final level, expressed in dBμV/m, is arrived at by taking the reading from the EMI receiver (Level dBμV) and adding the antenna correction factor and cable loss factor (Factor dB) to it. This result then has to be compared with the relevant FCC limit. The resolution bandwidth during the measurement is as follows: 9 kHz – 150 kHz: ResBW: 200 Hz 150 kHz – 30 MHz: ResBW: 9 kHz mikes-testingpartners gmbh File No. T30390-07-00AA, page 18 of 20 Ohmstrasse 2-4 x 94342 Strasskirchen Tel.:+49(0)9424-94810 x Fax:+49(0)9424-9481240 Rev. No. 1.1 5.4 Radiated emissions (electric field) 30 MHz – 1 GHz For test instruments and accessories used see section 6 Part SER 2. 5.4.1 Description of the test location Test location: OATS1 Test distance: 3 metres 5.4.2 Photo documentation of the test set-up