2AVOO-RE1RAReal ear measurement system+Audiometer

Inventis SRL

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Application Details

Equipment Class: DCD - Part 15 Low Power Transmitter Below 1705 kHz
Date of Grant: Jul 21, 2020
Application Purpose: Original Equipment
Date of Application: Jul 20, 2020
Equipment Note: Real ear measurement system+Audiometer
Frequency Range: 0.14230000 - 0.14230000
Company: Inventis SRL
Country: Italy

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Document Text

Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.

Users Manual

TRUMPET REAL EAR MEASUREMENTS SYSTEM AUDIOMETER USER MANUAL ii iii Read this manual carefully before using the instrument. Pay particular attention to the instructions given in Chapter 1 (“Safety: warnings and information”) and in Chapter 3 (“Installation”). Internal inspection and servicing of the instrument must be entrusted entirely to technicians approved by Inventis S.r.l. Copyright: Inventis S.r.l. is the owner of the copyright on this manual. It is forbidden to copy, reproduce or alter the manual, in its entirety or in part, without the express written authorization of Inventis S.r.l.. Inventis ® is a registered trademark owned by Inventis S.r.l.. Inventis S.r.l. Corso Stati Uniti, 1/3 35127 Padova, Italia Tel.: 049.8962844 Fax: 049.8966343 www.inventis.it [email protected] Revision: 17 Date: 24/06/2020 v Summary Summary ....................................................................................v CHAPTER 1 Safety: warnings and information ................... 1 1.1 User Manual ............................................................ 1 1.2 Operator responsibilities ........................................ 1 1.3 Intended use of the device ...................................... 2 1.4 Indication for use and end users of the device...... 2 1.5 Precautions .............................................................. 3 1.6 Disposal .................................................................... 6 1.7 Conformity ............................................................... 7 1.8 FCC/ISED use restrictions and warnings ............. 7 1.9 Symbols on labels .................................................... 9 CHAPTER 2 Introduction .................................................... 11 2.1 Description of the product .................................... 11 2.2 Accessories ............................................................. 13 2.3 Preparation for an REM test ............................... 20 CHAPTER 3 Installation ...................................................... 31 3.1 Connections............................................................ 31 CHAPTER 4 Maintenance ................................................... 39 4.1 Calibration and equalization (REM)................... 39 4.2 Periodic checks ...................................................... 40 4.3 Cleaning and maintenance of transducers.......... 40 vi 4.4 Replaceable parts .................................................. 41 4.5 Repairs and technical assistance .......................... 42 4.6 Enable new licenses ............................................... 42 4.7 Firmware upgrade ................................................ 43 4.8 Calibration of microphones by code.................... 43 APPENDIX A: Technical Specifications ............................. 45 REM specifications ................................................................ 45 Audiometer specifications ...................................................... 47 Other specifications ................................................................ 53 APPENDIX B: Specifications of speaker for free field tests ................................................................................................. 59 APPENDIX C: Troubleshooting .......................................... 61 APPENDIX D: Electromagnetic emissions ......................... 65 1 CHAPTER 1 Safety: warnings and information 1.1 USER MANUAL Be sure to read this manual through completely, so that all of the features offered by the Trumpet instrument can be used to their full potential. In particular, be sure to read this chapter in its entirety, as it contains information and warnings that are of fundamental importance in ensuring safe and correct use of the device. The safety warning symbol illustrated below is used in this manual to draw the attention of the reader to information of particular importance in matters of safety, and to guard against incorrect use. 1.2 OPERATOR RESPONSIBILITIES The Trumpet device guarantees consistent and dependable performance only when used in accordance with the instructions and procedures described in this manual. In the event of the device malfunctioning and needing to undergo repair or maintenance work, it must be disconnected from the electrical power supply, and not used again until after this work has been completed. When defective or failed parts must be renewed, accept only original replacement parts supplied by Inventis s.r.l. Any repairs must be entrusted exclusively to Inventis or to service technicians approved by Inventis. No parts of the device must be modified or replaced without authorization from Inventis. 2 The user of the device assumes full responsibility for any malfunction resulting from improper use or operation, likewise from maintenance or repair work performed by third parties other than Inventis s.r.l. or Service Centres approved by Inventis. Inventis s.r.l. and approved Service Centres will answer for the performance and reliability of the equipment only if: 1. adjustments, modifications or repairs have been entrusted to persons authorized by Inventis; 2. the electrical system and earthing of the installation are in compliance with the specifications of standards for electro-medical appliances. 1.3 INTENDED USE OF THE DEVICE Trumpet is a real ear measurement system. A real ear measurement system allows the determination of the intensity of sounds reaching the tympanic membrane of the patient. To this end it uses a couple of microphones, one located at the level of the patient’s earlobe (the reference microphone), and one inserted in the patient ear canal through a silicon tube (the probe microphone). The operator, using the system, delivers to the patient sound stimuli different in intensity and in frequency content, and measures the intensity of the sound received by the two microphones. A real ear measurement system is generally used to quantify the gain provided by a hearing aid, when this is …

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Cover Letter(s)

Inventis srl Corso Stati Uniti 1/3 35127 Padova (PD), Italy Equipment Autorisation Division Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 FCC ID: 2AVOO-RE1RA Product Name: Real ear measurement system + Audiometer Request for Confidentiality Pursuant to Sections 0.457(d) and 0.459 of the commissions rules, we hereby request that the following documents be held confidential: • Schematics • Block diagrams • Operation Description • Part list These materials contain trade secrets and proprietary information and are not customarily released to the public. The public disclosure of this information might be harmful to the company and provide unjustified benefits to our competitors. Dated this 12 Day of June 20 20 By: Massimo Martinelli Signature Printed Title: Managing Director On behalf of : Inventis SRL Telephone: +39 347 7045497

Cover Letter(s)

Inventis srl Corso Stati Uniti 1/3 35127 Padova (PD), Italy Nemko Canada Inc 303 River Road Ottawa, Ontario, Canada K1V 1H2 Attn: Director of Certification Authority to Act as Agent On our behalf, I appoint Nemko Canada Inc. to act as our agent in the preparation of this application for equipment certification. I certify that submitted documents properly describe the device or system for which equipment certification is sought. I also certify that each unit manufactured, imported or marketed, as defined in Industry Canada’s regulations will have affixed to it a lab identical to that submitted for approval with this application. For instances where our authorized agent signs the application for certification on our behalf, I acknowledge that all responsibility for complying with the terms and conditions for certification, as specified by Nemko Canada Inc, still resides with Inventis srl, Corso Stati Uniti 1/3, 35127 Padova (PD), Italy. Dated this 12 Day of June 20 20 Agency agreement expiration date: 27 April 2021 By: Massimo Martinelli Signature Printed Title: Managing Director On behalf of : Inventis SRL Telephone: +39 347 7045497

Cover Letter(s)

Inventis srl Corso Stati Uniti 1/3 35127 Padova (PD), Italy Model Differences Letter The Trumpet family of products for North America market is composed by: Trumpet REM & AUD Wireless Trumpet REM & AUD Trumpet REM Wireless Trumpet REM Trumpet AUD The only difference between them is: No external or internal difference, aesthetic or electrical, is present between the models in the main Trumpet unit. The models differ only for the provided transducers and licenses, that are exclusively software-related. The family representative is “Trumpet REM & AUD Wireless” because it is provided with the most comprehensive set of transducers and licenses. Model Main device hardware (Trumpet) Equipped transducers Active licenses (SOFTWARE) Trumpet REM & AUD Wireless ☒RE1-EL001 board ☒RE1-EL002 board ☒RE1-EL009 board ☒Wireless REM probe (RE1-EL007 board) ☒Audiometric transducers ☐Wired REM probe ☒REM license ☒AUD license Trumpet REM & AUD ☒RE1-EL001 board ☒RE1-EL002 board ☒RE1-EL009 board ☐Wireless REM probe (RE1-EL007 board) ☒Audiometric transducers ☒Wired REM probe ☒REM license ☒AUD license Trumpet REM Wireless ☒RE1-EL001 board ☒RE1-EL002 board ☒RE1-EL009 board ☒Wireless REM probe (RE1-EL007 board) ☐Audiometric transducers ☐Wired REM probe ☒REM license ☐AUD license Trumpet REM ☒RE1-EL001 board ☒RE1-EL002 board ☒RE1-EL009 board ☐Wireless REM probe (RE1-EL007 board) ☐Audiometric transducers ☒Wired REM probe ☒REM license ☐AUD license Trumpet AUD ☒RE1-EL001 board ☒RE1-EL002 board ☒RE1-EL009 board ☐Wireless REM probe (RE1-EL007 board) ☒Audiometric transducers ☐Wired REM probe ☐REM license ☒AUD license Inventis srl Corso Stati Uniti 1/3 35127 Padova (PD), Italy The customer can buy a license or a different set of transducers after buying a specific model. For example, if he buys a Trumpet REM that is provided with a wired probe, he can buy a wireless probe afterwards and use the software to instruct the device to use the wireless probe instead of the wired one. According to RSP 100, Issue 12, Clause 9.3: Multiple versions of a product design are permitted to be certified under a single family certification service with one ISED Certification Number provided that all the product variants within a family certification meet the following conditions: Clause Response a. the enclosure and general appearance of all product versions in a family certification shall be identical except for enclosure colour and/or minor external cosmetic differences There is no difference in the main device between models of the same family: it is exactly the same device except for the label on the back (see below) b. two or more versions of a product with one printed circuit board (PCB) design with different frequency bands/technologies enabled by software The only change that can be enabled by the software is to enable or not the Bluetooth communication for the wireless probe, for all the models c. a new version of a certified product which may have minor PCB modifications to improve existing frequency bands/technologies and/or add non-RF features First radio certification d. all the product versions within the family certification shall be identical or have differences permitted under Class I and III permissive changes All the products within the family certification are identical. Inventis srl Corso Stati Uniti 1/3 35127 Padova (PD), Italy Label difference images: Trumpet REM & AUD Wireless Inventis srl Corso Stati Uniti 1/3 35127 Padova (PD), Italy Trumpet REM & AUD Inventis srl Corso Stati Uniti 1/3 35127 Padova (PD), Italy Trumpet REM Wireless Inventis srl Corso Stati Uniti 1/3 35127 Padova (PD), Italy Trumpet REM Inventis srl Corso Stati Uniti 1/3 35127 Padova (PD), Italy Trumpet AUD Inventis srl Corso Stati Uniti 1/3 35127 Padova (PD), Italy Dated this 12 Day of June 20 20 By: Massimo Martinelli Signature Printed Title: Managing Director Telephone: +39 347 7045497 Applicant: Inventis SRL

External Photos

ID Label/Location Info

Internal Photos

INVENTIS S.R.L. CORSO STATI UNITI, 1/3 35127 PADOVA - ITALIA TEL: +39 049.8962 844 FAX: +39 049.8966 343 C.F./P.IVA:IT03957810280 R.E.A. PD 350789 [email protected] WWW.INVENTIS.IT INTERNAL PHOTOS Real ear measurement system + Audiometer FCC ID: 2AVOO-RE1RA IC: 25857-RE1RA - Trumpet REM & AUD Wireless - Trumpet REM & AUD - Trumpet REM Wireless - Trumpet REM - Trumpet AUD The following photographic documentation is absolutely identical (aesthetically and mechanically) for all the product variants: All PCBs, wirings and components are the same for all the above listed variants which are electrically identical. INVENTIS S.R.L. CORSO STATI UNITI, 1/3 35127 PADOVA - ITALIA TEL: +39 049.8962 844 FAX: +39 049.8966 343 C.F./P.IVA:IT03957810280 R.E.A. PD 350789 [email protected] WWW.INVENTIS.IT RE1-EL001 board – top view (for components reference, please refer to the appendix) INVENTIS S.R.L. CORSO STATI UNITI, 1/3 35127 PADOVA - ITALIA TEL: +39 049.8962 844 FAX: +39 049.8966 343 C.F./P.IVA:IT03957810280 R.E.A. PD 350789 [email protected] WWW.INVENTIS.IT RE1-EL001 board – bottom view (for components reference, please refer to the appendix) INVENTIS S.R.L. CORSO STATI UNITI, 1/3 35127 PADOVA - ITALIA TEL: +39 049.8962 844 FAX: +39 049.8966 343 C.F./P.IVA:IT03957810280 R.E.A. PD 350789 [email protected] WWW.INVENTIS.IT RE1-EL002 board – top view (for components reference, please refer to the appendix) INVENTIS S.R.L. CORSO STATI UNITI, 1/3 35127 PADOVA - ITALIA TEL: +39 049.8962 844 FAX: +39 049.8966 343 C.F./P.IVA:IT03957810280 R.E.A. PD 350789 [email protected] WWW.INVENTIS.IT RE1-EL002 board – bottom view (for components reference, please refer to the appendix) INVENTIS S.R.L. CORSO STATI UNITI, 1/3 35127 PADOVA - ITALIA TEL: +39 049.8962 844 FAX: +39 049.8966 343 C.F./P.IVA:IT03957810280 R.E.A. PD 350789 [email protected] WWW.INVENTIS.IT RE1-EL009 board – top view (for components reference, please refer to the appendix) INVENTIS S.R.L. CORSO STATI UNITI, 1/3 35127 PADOVA - ITALIA TEL: +39 049.8962 844 FAX: +39 049.8966 343 C.F./P.IVA:IT03957810280 R.E.A. PD 350789 [email protected] WWW.INVENTIS.IT RE1-EL009 board – bottom view (for components reference, please refer to the appendix) INVENTIS S.R.L. CORSO STATI UNITI, 1/3 35127 PADOVA - ITALIA TEL: +39 049.8962 844 FAX: +39 049.8966 343 C.F./P.IVA:IT03957810280 R.E.A. PD 350789 [email protected] WWW.INVENTIS.IT RE1-EL001 and RE1-EL002 boards assembly RE1-EL009 board bottom part assembly Trumpet frontal view – no speaker grid Frontal speaker unmounted INVENTIS S.R.L. CORSO STATI UNITI, 1/3 35127 PADOVA - ITALIA TEL: +39 049.8962 844 FAX: +39 049.8966 343 C.F./P.IVA:IT03957810280 R.E.A. PD 350789 [email protected] WWW.INVENTIS.IT RE1-EL001 and RE1-EL002 boards assembly before adding the chassis Internal view of the boards assembly place INVENTIS S.R.L. CORSO STATI UNITI, 1/3 35127 PADOVA - ITALIA TEL: +39 049.8962 844 FAX: +39 049.8966 343 C.F./P.IVA:IT03957810280 R.E.A. PD 350789 [email protected] WWW.INVENTIS.IT Placement of the RE1-EL009 Bluetooth board Back of the speaker Appendix

RF Exposure Info

This Test Report, when bearing the Nemko name and logo is only valid when issued by a Nemko laboratory, or by a laboratory having special agreement with Nemko. TEST REPORT Title 47-Telecommunication Chapter I - Federal Communications Commission Subchapter A - General Part 1 - Practice and procedure Subpart I - Procedures Implementing the National Environmental Policy Act of 1969 Report Reference No. ................. : 381371-2TRFEMF Tested by (name, function and signature) ..... : P. Barbieri (project handler) Approved by (name, function and signature) ..... : D. Guarnone (verifier) Date of issue ................................. : 2020-05-15 Testing Laboratory ..................... : Nemko Spa Address ......................................... : Via del Carroccio, 4 – 20853 Biassono (MB) – Italy Testing location Nemko Spa Address ......................................... : Via del Carroccio, 4 – 20853 Biassono (MB) – Italy Registration number: 682159 and 9109A Applicant’s name ........................ : Inventis SRL Address ......................................... : Corso Stati Uniti, 1/3 – 35127 Padova (PD) – Italia Test specification: Standard ....................................... : FCC CFR 47 Part 1 Subpart I §1.1310 – Radiofrequency radiation exposure limits Test procedure.............................. : Nemko WM L0077, WM L0177 and WM L1002 Test Report Form No. ................. : FCCTRF TRF Originator .............................. : Nemko Spa Master TRF ................................... : 2014-03 Nemko Spa, 20853 Biassono (MB), Italy. All rights reserved. This publication may be reproduced in whole for non-commercial purposes as long as Nemko Spa is acknowledged as copyright owner and source of the material. Nemko Spa takes no responsibility for and will not assume liability for damages resulting from the reader's interpretation of the reproduced material due to its placement and context. Test item description ................ : Real ear measurement system + Audiometer Trade Mark ................................... : Inventis Manufacturer ................................. : Inventis SRL Address of manufacturer .............. : Corso Stati Uniti, 1/3 – 35127 Padova (PD) – Italia FCC ID .......................................... : 2AVOO-RE1RA Model ............................................ : TRUMPET REM & AUD Wireless Variants ......................................... : Trumpet REM & AUD; Trumpet REM Wireless; Trumpet REM; Trumpet AUD Ratings .......................................... : 100 – 240 V ~ 47 – 63 Hz This test report may not be partially reproduced, except with the prior written permission of Nemko Spa The test report merely corresponds to the tested sample. The phase of sampling / collection of equipment under test is carried out by the customer. Page 2 of 16 Report No. 381371-2TRFEMF Test Report No. : 381371-2TRFEMF 2020-05-15 ____________________________________________________________________________________________ Date of issue Short description of the EuT and Copy of marking plate Trumpet is a real ear measurement system. A real ear measurement system allows the determination of the intensity of sounds reaching the tympanic membrane of the patient. To this end it uses a couple of microphones, one located at the level of the patient’s earlobe (the reference microphone), and one inserted in the patient ear canal through a silicon tube (the probe microphone). The operator, using the system, delivers to the patient sound stimuli different in intensity and in frequency content, and measures the intensity of the sound received by the two microphones. A real ear measurement system is generally used to quantify the gain provided by a hearing aid, when this is worn by the patient. Trumpet can be also an audiometer. An audiometer is a device that helps the operator in defining the patient’s auditory sensitivity by generating and delivering to the patient sound stimuli of different types and intensities for diagnostic purposes. Number of tested samples: 1 Serial number: RE1RA20100003 Operating frequency: 110 kHz to 205 kHz Accessories and detachable parts included: The E.U.T. is composed of two units Other options included: - Testing Date of receipt of test sample: 2020-05-15 Testing commenced on: 2020-05-15 Testing concluded on: 2020-05-15 Possible test case verdicts: test case does not apply to the test object: N (Not applicable) test object does meet the requirement: P (Pass) test object does not meet the requirement: F (Fail) Symbols used in this test report The crossed square indicates that the listed condition or equipment is applicable for this report. The empty square indicates that the listed condition or equipment is not applicable for this report. Throughout this report point is used as decimal separator. The results contained in this report reflect the results for this particular model and serial number. It is the responsibility of the manufacturer to ensure that all production models meet the intent of the requirements detailed within this report. Verdict according to the standards listed at page 5: Pass Page 3 of 16 Report No. 381371-2TRFEMF PROJECT HISTORY Report number Modification to the report / comments Date 381371-2TRFEMF First release 2020-05-15 -- -- -- -- -- -- -- -- -- REMARKS -- PRODUCT VARIANTS Variant model Difference against the main model Test performed -- -- -- -- -- -- -- -- -- -- -- -- REMARKS -- Page 4 of 16 Report No. 381371-2TRFEMF Contents 1 T E S T S T A N D A R D S 5 2 S U M M A R Y O F T E S T R E S U L T S 5 3 E Q U I P M E N T U N D E R T E S T 6 3.1 POWER SUPPLY SYSTEM UTILISED 6 3.2 EUT OPERATION MODES 6 3.3 EUT CONFIGURATION MODES 6 3.4 INPUT/OUTPUT PORTS 6 3.5 EQUIPMENT USED DURING TEST 7 3.6 TEST SOFTWARE 8 4 T E S T E N V I R O N M E N T 9 4.1 ADDRESS OF THE TEST LABORATORY 9 4.2 ENVIRONMENTAL CONDITIONS 9 4.3 STATEMENT OF THE MEASUREMENT UNCERTAINTY 9 5 T E S T C O N D I T I O N S A N D R E S U L T S 1 1 5.1 RADIOFREQUE…

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Test Report

Report reference ID: 381371-3TRFWL Page 1 of 31 This test report may not be partially reproduced, except with the prior written permission of Nemko Spa The test report merely corresponds to the tested sample. The phase of sampling / collection of equipment under test is carried out by the customer. ONE WORLDOURAPPROVAL Test report 381371-3TRFWL Date of issue: 2020-03-19 Applicant: Inventis SRL Corso Stati Uniti, 1/3 – 35127 Padova (PD) – Italia Product: Real ear measurement system + Audiometer Model: Trumpet REM & AUD Wireless; Trumpet REM & AUD Trumpet REM Wireless; Trumpet REM; Trumpet AUD FCC ID: IC Registration number: 2AVOO-RE1RA 25857-RE1RA Specifications:  FCC 47 CFR Part 15 Subpart C Intentional radiators Report reference ID: 381371-3TRFWL Page 2 of 31 Test location Company name: Nemko Spa Address: Via del Carroccio, 4 City: Biassono Province: MB Postal code: 20853 Country: Italy Telephone: +39 039 220 12 01 Facsimile: +39 039 220 12 21 Website: www.nemko.com Site number: FCC: 682159 Tested by (name, function and signature) P. Barbieri (project handler) Reviewed by (name, function and signature) D. Guarnone (verifier) Date: 2020-03-19 Limits of responsibility Note that the results contained in this report relate only to the items tested and were obtained in the period between the date of initial receipt of samples and the date of issue of the report. This test report has been completed in accordance with the requirements of ISO/IEC 17025. All results contain in this report are within Nemko Spa ISO/IEC 17025 accreditation. Copyright notification Nemko Spa authorizes the applicant to reproduce this report provided it is reproduced in its entirety and for use by the company’s employees only. Any use which a third party makes of this report, or any reliance on or decisions to be made based on it, are the responsibility of such third parties. Nemko Spa accepts no responsibility for damages, if any, suffered by any third party as a result of decisions made or actions based on this report. Report reference ID: 381371-3TRFWL Page 3 of 31 Table of contents Table of contents .......................................................................................................................................................................................................... 3 Section 1. Report summary ................................................................................................................................................................................. 4 1.1 Applicant and manufacturer .................................................................................................................................................................................... 4 1.2 Test specifications .................................................................................................................................................................................................... 4 1.3 Test methods ............................................................................................................................................................................................................ 4 1.4 Statement of compliance ......................................................................................................................................................................................... 4 1.5 Exclusions ................................................................................................................................................................................................................. 4 1.6 Test report revision history ...................................................................................................................................................................................... 4 Section 2. Summary of test results ....................................................................................................................................................................... 5 2.1 FCC Part 15 Subpart C, general requirements test results ........................................................................................................................................ 5 Section 3. Equipment under test (EUT) details ..................................................................................................................................................... 6 3.1 Sample information .................................................................................................................................................................................................. 6 3.2 EUT information ....................................................................................................................................................................................................... 6 3.3 Technical information .............................................................................................................................................................................................. 6 3.4 Product description and theory of operation ........................................................................................................................................................... 6 3.5 EUT exercise details .................................................................................................................................................................................................. 6 3.6 EUT setup diagram ................................................................................................................................................................................................... 7 3.7 EUT sub assemblies ...................................................................................................................................…

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