TRUMPET REAL EAR MEASUREMENTS SYSTEM AUDIOMETER USER MANUAL
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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.
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 ......................................
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 .............................................................
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 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. 2. 1.
These tests must be conducted in a quiet environment to avoid artifacts and to ensure that errors are not committed when determining the hearing threshold. 1.5 PRECAUTIONS To ensure correct and safe use of the device, the following precautions must be observed. 1.4.1 Installation and general precautions Make certain that the required ambient conditions are met (during transport, storage and operation).
The Trumpet has been tested under the following ambient conditions: Temperature between 18 °C and 28 °C Relative humidity between 20% and 80% Atmospheric pressure between 81.3 kPa and 106.3 kPa. The Trumpet is designed for use after being positioned on a stable work surface (such as a desk) or a suitable supporting structure (such as a stand).
When conducting audiometry tests, the presence of a transducer that has not be calibrated will be flagged by the software. It will not be possible to present any stimulus to the patient using transducers that have not been calibrated. Take note of the calibration interval indicated for the audiometer and the REM probes. Use of the instrument beyond the calibration interval expiry date can lead to unreliable diagnoses. 1.4.
these levels are amplified by a hearing aid, the same kind of damage can occur in as little as 30 seconds. To avoid any such risks when conducting an REM test, make certain that the thresholds of the hearing aid have been set correctly, if necessary after running the MPO (Maximum Power Output) test using the relative function included in the Maestro software application (refer to Maestro – Fitting and hearing aid test functionalities – User Manual).
Thanks to the sorted collection of waste items and the subsequent processing, recovery and disposal operations they undergo, appliances can be made from recycled materials, and any negative impact of improper waste management on the environment and on health can be suitably limited. 1.7 CONFORMITY The Inventis Trumpet device is a class II device, in accordance with Annex IX of the medical devices directive 93/42/EEC as amended and supplemented by directive 2007/47/EC. Inventis s.r.l.
instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: • • • • Reorient or relocate the receiving antenna.
1.9 SYMBOLS ON LABELS Name and address of manufacturer. Warning: the use of this instrument calls for certain precautions; to ensure safe use, consult the accompanying documentation. Read the operator manual. This symbol indicates that the product is subject to the requirements of Directive 2012/19/EU on waste electrical and electronic equipment (WEEE). In the event of this product being sold and/or scrapped, it must not be disposed of as ordinary household or industrial waste, but collected separately.
CHAPTER 2 Introduction 2.1 DESCRIPTION OF THE PRODUCT The Trumpet is an REM device allowing in-situ evaluation of all the parameters required to ensure optimum fitting of a hearing aid. It is characterized by a small and lightweight set of probes, and a powerful speaker mounted to the front panel of the instrument. The Trumpet is also a diagnostic audiometer that can be used to perform pure tone and speech audiometry by air or bone conduction.
During an REM test, the instrument can operate only in FF (Free Field) mode, and the power adapter must be connected (see chapter entitled 3 Installation). The following table summarizes the tests that can be conducted in audiometer mode. Test PURE TONE AUDIOMETRY AUTOTHRESHOLD SPEECH AUDIOMETRY MASTER HEARING AID Channel Inputs Outputs Ch. 1 Pure tone, warble, NBN AC, BC, FF Ch. 2 NBN, WN AC, BC, FF Ch. 1 Pure tone AC Ch. 1 Ch. 2 Ch. 1 Ch.
2.2 ACCESSORIES The Trumpet can be supplied with all or only certain of the accessories described, depending on the module purchased. If a licence is purchased at a later time, then the corresponding accessories will also be supplied (those not included in the version of the instrument purchased initially). The table below lists the accessories included in the relative modules.
Operator Manuals RECD unit • opt. Audiometer version Trumpet unit • Supra-aural headphones (Telephonics TDH-39 or Radioear DD45) • Insert earphones (Etymotics ER-3C) opt. Noise-excluding enclosures (Amplivox Audiocups) opt.
2.2.1 Probes (REM) Two probes are located at the ends of the REM headset. Detailed description below: F G A B D C A. Housing for probe tube B. Probe tube C. O-ring for attachment to ear D. Reference microphone E E. Graduated scale F. Guide housing for insertion of tube G. Probe calibration guides It is advisable, where possible, to use the REM probes inserted in the headset Insertion of probe tube The Trumpet comes with a set of probe tubes (REM licence).
A B A. Button with status LED B. Bluetooth transmitter (battery compartment on the back) To turn the probes on it is sufficient to press the transparent button in the center. The status LED will begin to blink in blue while searching for the Trumpet, and it will become orange when it is connected to it.
The probes LED will turn green for a short time to confirm the start of the charging phase, then it will turn orange again. If the LED does not turn green, try to slightly change the position of the probes since they are aligned with the center of the device, or try to put them off charge position, wait 5 seconds then put them back on paying particular attention to the fact that they are correctly placed in the center of the device.
It is strongly advised to put the probes on charge when they are not in use, to avoid to reach a low charge level and not being able to complete the exam. The correct insertion polarity of the batteries is the following: + The “–” pole of the battery with the “VARTA” writing shall be face down while inserting it in the slot. If the probes are sold together with the Trumpet they will already be paired with the device, otherwise before using them it is necessary to perform the pairing procedure: 1. 2. 3. 4.
Ensure that there is no other Trumpet connected to the power plug and to the USB plug in the surroundings, otherwise the probes could pair to the wrong device. In case of any problemi it is possible to turn off the probes manually by keeping the button pressed for more than 10 seconds. They are however turned off every time that Trumpet is not in use by Maestro, unless they are in charge position.
2.3 PREPARATION FOR AN REM TEST The REM test must be conducted only by a person specialized in and authorized to perform audiology procedures. Use of the instrument by a person without the necessary expertise could result in damage to the hearing of the patient. Change the probe for each new patient. Reusing the tube on different people could result in the spread of ear infections. Do not push the tube too far into the patient's ear: there is the risk of perforating the eardrum.
markings of the ruler on the headset as indicated in the image below). The recommended distances are: a. b. c. Men: 27 mm Women: 27 mm Children: 20-25 mm NOTE: the distances can vary depending on the patient. To avoid problems, in any event, start with an ear inspection: this will give some idea as to the dimensions of the auditory canal. 3. Position the probe headset on the patient, adjusting the loops (Orings) so that the probe is positioned just under the ear lobe. 4.
In this way it will be possible to ensure the probe tube is kept straight when inserted into the auditory canal. 5. If required for the measurement (i.e. for REAR measurements), place the hearing aid in the patient's ear, making certain that the probe tube remains in the same position and is not occluded by the hearing aid.
It is very important that the probe microphones are correctly calibrated every time a new tube is used. Incorrect or failed calibrations can influence the acquisition of curves and lead to false measurements. It is advisable, where possible, to use the REM probes inserted in the headset 2.3.
RECD unit Before proceeding with the test, the speaker of the RECD unit must be equalized and the microphones calibrated. The operation requires that the coupler microphone and the reference microphone, suitably aligned one with another, should be positioned on the speaker of the RECD unit as illustrated in the image below. For further information, refer to the heading entitled Coupler measurements in Maestro – Fitting and hearing aid test functionalities – User manual.
1 2 3 - - Adapter (1) is designed for use with ITE, ITC and CIC hearing aids. Make certain that hearing aid is securely connected by using adhesive insulating putty. Adapter (2) allows connection of BTE type hearing aids to coupler using an ear hook. Adapter (3) is designed for use with RIC hearing aids. Here again, always use adhesive insulating putty to make certain of a secure connection.
Before a fitting procedure can be carried out using the RECD unit, the operator must always begin with the acquisition of an RECD curve, so that all the measurements made with the coupler can effectively simulate those normally obtainable in the ear. The software will enable the coupler measurement functionality only after the acquisition of an RECD curve has occurred. The acquisition of an RECD curve involves two steps: measurement of a response in the ear and measurement of a response in the coupler.
Once the measurement in the ear has been obtained, the response in the coupler can be measured. Electing to use a disposable tip for acquisition of the measurement in the ear, the response in the coupler can be measured only with the adapter (1): this situation is identified as the HA1 configuration. Accordingly, connect the adapter (1) to the coupler, and the insert transducer to the tip.
The response in the auditory canal can also be measured using the earmold of the patient's hearing aid, rather than a disposable tip. Likewise in this instance, the probe tube must first be inserted in the auditory canal of the patient as described in Heading 2.3.1, following which the mold, connected previously to the insert transducer, can be placed in the ear. Here again, special care must be taken during the operation to avoid displacing the probe tube inserted previously from its correct position.
HA1-mold configuration The second configuration, on the other hand, identified as HA2, requires the connection of the adapter (2) to the coupler.
When both measurements have been taken, in the ear and in the coupler, the difference between them allows automatic calculation of the RECD curve, which will be used during the course of the coupler mode fitting procedure. For further details on using the Maestro software for acquisition of the RECD curve, refer to the heading entitled RECD in the Operator manual Maestro – Fitting and hearing aid test functionalities – User Manual.
CHAPTER 3 Installation Whilst the installation of the Trumpet device is a relatively simple procedure, it should be entrusted to a person with the requisite skills. If the installation is not performed correctly, the system could be affected by safety problems when in use. This chapter describes the procedure for installing the system. Keep the packaging materials, in case the instrument should need to be sent to the dealer or to Inventis for any reason. 3.1 CONNECTIONS 3.1.
Plug the transducers and accessories into the respective sockets as indicated in the following table: Connector PAT.
Connect the power adapter to the input and to the relative power cord, which should be plugged into an a.c. mains socket supplying the voltage indicated on the adapter label. All connections must be made with the instrument switched off, or at least before plugging in the power cord and the USB cable. Use only the power adapter supplied by Inventis s.r.l. Connect the device only to medical equipment or to devices equipped with an isolating transformer.
Connector PROBE Accessory Set of wired probes used for REM measurements A Led positioned around the connector indicates the communication status between the Trumpet and the computer. Whenever the device is communicating with the PC controlling it, the Led will remain alight.
3.1.
PC/Power supply 3.1.
Speakers for free field tests Option 1: External speakers Option 2: RECD speaker + built-in Trumpet speaker (*) Option 3: Built-in Trumpet speaker only (*) In this configuration, the built-in speaker functions as the left hand and the RECD speaker as the right hand. Before using any one of the three options, calibration of the relative speakers in free field conditions is required. Options 1 and 2 must be enabled by an authorized technician during the calibration procedure.
PC/Power supply 3.1.5 Positioning the device The Trumpet can be positioned: • on a table, • mounted on a stand, • wall mounted using a standard VESA bracket (optional), • wall-mounted using a dedicated bracket, which can also house the AUD transducers (optional) When securing the Trumpet to a VESA wall mount, take care to use M4 screws that penetrate the threaded holes to a depth of no more than 6 mm.
CHAPTER 4 Maintenance When cleaning operations of any kind are required, the instrument must first be disconnected and switched off by unplugging the power cord and the USB cable. Internal inspection and servicing of the instrument must be entrusted entirely to technicians approved by Inventis S.r.l. Transducers are manufactured utilizing ultra-fragile diaphragms that could be damaged in the event of impact. Handle with care during maintenance operations.
If an RECD unit is being used, the calibration of the reference microphone must be validated by technicians approved by Inventis S.r.l. The operation should be carried out at least once every 12 months, and whenever the coupler is replaced. 4.2 PERIODIC CHECKS To maximize the service life of the instrument and all its accessories, it is advisable that the following tests be carried out on a daily basis: The tests must be conducted with the instrument positioned for normal use.
these items are to be used on a new patient, always wipe the surfaces with a hypoallergenic proprietary disinfectant, following the maker's instructions. The earpieces of insert earphones are made of biocompatible material and must be used once only, then discarded in compliance with current waste disposal regulations.
4.5 REPAIRS AND TECHNICAL ASSISTANCE Before contacting the service department, make certain that all the possible solutions in the "Troubleshooting" appendix C have been tried. There are no requirements for the sterilization or disinfection of parts being returned to the manufacturer for repair and servicing.
The licenses currently active on the device are shown in the central area of the window. Enter the license key received from Inventis in the 5 fields (4 characters per field), exactly as written on the license document. Now click the “Enable License” button: if the license has been enabled, a message confirms the success of the operation and the relative check box in the central part of the screen will be ticked.
APPENDIX A: Technical Specifications REM specifications REM classification Real Ear Measurement system, class 2a (MDD 93/42) REM GENERAL SPECIFICATIONS Frequency range 125 Hz – 12 kHz Reference microphones measurement range Probe microphones measurement range 40 – 110 dB SPL Stimulus intensity at 1 m 50 dB SPL – 90 dB SPL, steps of 5 dB (+/- 3 dB) Equalization method Modified Pressure Method with Concurrent Equalization (Stored Equalization for open fitting) Analysis 1/3 – 1/24 octave bands (selec
• • Pink noise (PN) White noise (WN).
Audiometer specifications Audiometer classification Pure tone audiometer type 2 and speech audiometer class A (IEC 60645-1, ANSI S3.6) SIGNALS AVAILABLE FOR AUDIOMETRY Type Tone Warble tone MIC input for speech audiometry (live speech)* Narrow band noise (NBN) White noise (WN). Speech noise (SN) • • • • • • *the microphone must be positioned in front of the operator's mouth. Attenuator step Presentation mode SIGNAL CHARACTERISTICS 1, 2 and 5 dB Continuous Pulsed at a rate of 0.
• Stenger PURE TONES AND WARBLE AVAILABLE FREQUENCIES AND MAXIMUM OUTPUTS Freq. (Hz) AC TDH39 DD451 (dB HL) AC ER-3C1 (dB HL) BC1 (dB HL) FF Int. 2 (dB HL) FF Ext. 2 (dB HL) 125 250 500 750 1.000 1.500 2.000 3.000 4.000 6.000 8.
NBN, WN AND SN MASKING AVAILABLE FREQUENCIES AND MAXIMUM OUTPUTS Freq. (Hz) 125 250 500 750 1.000 1.500 2.000 3.000 4.000 6.000 8.000 WN SN AC TDH391 (dB EM) AC DD451 (dB EM) AC ER-3C1 (dB EM) BC1 (dB FL) FF Int. 2 (dB HL) FF Ext.
COMPATIBLE TRANSDUCERS Type Supra-aural headphones Supra-aural headphones Insert earphones Bone vibrator Manufacturer Model Impedance Telephonics Corp. TDH39 10 ohm (1 kHz) Radioear Corp. DD45 10 ohm (1 kHz) Etymotic Research Inc. Radioear Corp. ER-3C B71 10 ohm (1 kHz) 10 ohm (1 kHz) AMBIENT NOISE ATTENUATION VALUES FOR TRANSDUCER TDH 39 / DD45 ER-3C Freq with MX41\AR or PN 51 cushions [Hz] [dB] [dB] 125 3 33.5 250 5 34.5 500 7 34.5 750 1000 15 35 1500 2000 26 33 3000 4000 32 39.
51 ISO 389-1 [dB] re 20 µPa] ISO 389-1 (ANSI S3.6) [dB] re 20 µPa] [Hz] 9.5 15.5 13 4000 6000 8000 12 20.5 9 8 8 8 6 0 2 5.5 3.5 3 2 0 2 5.5 14 26 [dB] re 20 µPa] ISO 389-2 (ANSI S3.6) ER 3C 40 40 35.5 30 31 36.5 42.5 48.5 58 67 - [dB] re 1 µPa] ISO 389-3 (ANSI S3.6) B71* FF 12.6 4.3 -5.4 -5.8 -1.3 2.4 2.4 2.4 4.4 11.4 22.1 [dB] re 20 µPa] ISO 389-7 (ANSI S3.
SPEECH AUDIOMETRY REFERENCE EQUIVALENT THRESHOLD VALUES IEC 60645-1 TDH39 DD45 ER 3C B71 Coupler: ANSI S3.7 (NBS-9A) / IEC 60318-3 (6cc) IEC 60318-5 IEC 60318-6 dB [re 20 µPa] 20.0 dB [re 20 µPa] 20.0 dB [re 1 µN] 55.0 dB [re 20 µPa] 20.0 Free field Referred to 0 degrees incidence dB [re 20 µPa] 20.0 Applied to USB, MIC, SPEECH NOISE and WHITE NOISE signals SPEECH AUDIOMETRY REFERENCE EQUIVALENT THRESHOLD VALUES ANSI S3.6 TDH39 DD45 ER 3C B71 Coupler: ANSI S3.
Other specifications CONTROL OF DEVICE By way of Inventis Maestro software installed on PC. • POWER SUPPLY Consumption 30 Watts 15V, 2A d.c. utilizing external adapter rated 100240 Vac 50/60 Hz (included in the pack), responding to EN 60601-1 standard Power supply Maximum emitted power Operating frequency band RADIO MODULES - 10 mW (Bluetooth module) - 37.
AMBIENT CONDITIONS Temperature between +15°C and +35°C Relative humidity: between 30% and 90% (no condensation) Pressure: between 700 hPa and 1060 hPa Temperature between -10°C and +50°C Relative humidity: 90% max, no condensation Pressure: between 500 hPa and 1060 hPa 1 minute Operation Transport and storage Warm-up time Dimensions (LxDxH) Weight of instrument only MECHANICAL 15.5 x 10 x 24.5 cm / 6.1 x 3.9 x 9,7 in 1.5 Kg / 3.
HEARING SAFETY FEATURES Alert situations: audible signal levels higher than 100 dB HL (IEC 60645-1) Audiometer Safety measures: 1) Activation of “higher dB” button required to raise intensity beyond 100 dB HL 2) Warning on test screen 3) Activation of channel "Norm.
SPECIFICATIONS OF OUTPUT TRANSDUCERS Output Voltage available TDH 39 DD45 ER 3C / RECD B 71 Free field (SPKF), Monitor 16Vpp 16Vpp 16Vpp 16Vpp 16Vpp Nominal impedance 10 Ω 10 Ω 10 Ω 10 Ω 4-8 Ω 1Vrms with 32 Ω load SPECIFICATIONS OF SIGNALS AVAILABLE WN Pure random noise, filtered Low cut-off frequency: 50 Hz High cut-off frequency: 20 kHz SN As specified in IEC 60645-1 PN Warble tone Pure random noise, filtered Low cut-off frequency: 50 Hz High cut-off frequency: 20 kHz Frequency of modulation s
APPLICABLE STANDARDS REM measurements Electrical safety IEC 61669 / ANSI S3.46 IEC 60645-1 / ANSI S3.
APPENDIX B: Specifications of speaker for free field tests To produce the intensity levels in free field conditions specified in Appendix A, the speaker utilized must meet the specifications indicated below.
APPENDIX C: Troubleshooting Problem No signal from a transducer No signal from patient response button when pressed No signal from monitor earphones Patient's voice cannot be heard Possible cause Solution Transducer not connected to correct output Connect the transducer to the correct output Transducer damaged Contact Inventis service department or dealer Wrong connection Connect the patient response button to the correct socket Patient response button damaged Contact Inventis service departm
Connection between PC and device cannot be established Results of test not credible Speaker equalization procedure not successful TALKBACK volume too low Adjust the TALK BACK volume by way of the Maestro control USB port of the computer not working Connect the instrument to a different USB port USB cable damaged Replace the USB cable (standard USB cable, type A/B) REM: Reference microphones not calibrated Request calibration of reference microphones REM: Equalization not valid Run speaker equali
REM reference microphone not functioning properly If the problem persists after several attempts, contact customer service Probe tube blocked or worn Change the probe tube Probe tube not inserted to the correct position for calibration purposes See heading 2.2.2 Probe tube calibration REM probes too far from speaker Bring the REM probes nearer, to around 0.
Speaker faulty Contact customer service When using the instrument in conjunction with a soundproof booth, check that the connections both inside the booth and between the booth and the instrument are correct and secure.
APPENDIX D: Electromagnetic emissions The instrument has been tested and been found to comply with the limits for electromedical devices imposed by EN 60601-1-2 standard. These limits guarantee a reasonable level of protection against harmful interference in a typical medical installation.
5) B-71 bone vibrator, 2 m braided cable, not shielded, dual signal (same as supplied with the device) 6) Patient headphones, manufacturer: Sennheiser, model: HD201 7) Monitor headphones with microphone, manufacturer: Sennheiser, model: PC3 (same as supplied with the device) 8) Clip-on talk-back microphone, 1 m shielded cable (same as supplied with the device) 9) Patient response button (made by Inventis), 2 m shielded cable 10) Insert earphones, manufacturer: Etymotic, model: ER-3C (same as supplied with t
Manufacturer's indications and declaration - electromagnetic immunity The Trumpet is designed for use in an electromagnetic environment as specified below. The user of the Trumpet must ensure that the instrument is operated in ambient conditions as specified.
ambient conditions as specified. Immunity tests Test level to EN 60601 Level of Compliance Electromagnetic environment guidelines In the event that there are portable and mobile RF communication appliances operating in the vicinity of the Trumpet, and the relative cables, be sure to maintain at least the recommended separation distance, calculated on the basis of the equation pertinent to the transmitter frequency.
directional position or the location of the Trumpet. b) In the frequency range from 150 kHz to 80 MHz, field strengths must be lower than 3 V/m. Recommended separation distances between portable and mobile RF communication appliances and the device The Trumpet is designed for use in electromagnetic environments where radiated RF interference phenomena are kept under control.
