Inventis TRUMPET User manual

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. 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.: [phone]
Fax: [phone]
www.inventis.it
[email protected]
Revision: 17
Date: 24/06/2020

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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 ............................... 19
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

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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

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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.

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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 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.
1.4 INDICATION FOR USE AND END USERS OF THE
DEVICE
Trumpet is intended for use by healthcare ENT professionals in hospitals,
ENT clinics and audiology offices or by hearing care professionals in
conducting hearing evaluations, in assisting in diagnosis of possible
otologic disorders, and in performing the verification of fitting of a hearing
aid.
There is no patient population restriction in the use of the device; always be
sure to perform an otoscopy before using the device.

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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 will not be protected if exposed during use to
flammable anaesthetic gases or similar products. Risk of
explosion.
Avoid installing and using the device near sources of strong
electromagnetic fields: these could interfere with the operation
of the equipment.
Use only original accessories supplied by Inventis s.r.l., unless
specifically indicated otherwise.
Use only the power adapter supplied by Inventis s.r.l.
The Trumpet is a medical device: if connected to a computer (or
any external device) located within the "patient area" (as
defined in EN 60601-1-1), this likewise must be a medical
device, or protected by an isolating transformer, in order to
ensure that the combination of computer (external device) +
Trumpet is in compliance with EN standard 60601-1-1.
The Trumpet can be used in conjunction with a soundproof
booth to conduct tests under optimum acoustic conditions.
Before connecting the instrument to a soundproof booth, check
that the sockets are compatible with the specifications
prescribed for each connector.

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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).
The Trumpet must be installed and operated taking account of
the information regarding electromagnetic compatibility (EMC)
provided in Appendix D of this manual
The proximity of portable and mobile appliances used for RF
communications can affect the operational efficiency of the
Trumpet box. Refer to the information regarding
electromagnetic compatibility (EMC) provided in Appendix D of
this manual.
1.4.2 Calibration
The calibration of the audiometer and the REM probes is
dependable only for the transducers supplied with the
instrument. If a transducer is replaced, the instrument must be
recalibrated.
The calibration of the audiometer and the REM probes is
dependable for transducers supplied with the product, if
connected directly to the instrument, without any interposition
of extension leads and without the passage from connectors to
panel (as habitually occurs in soundproof booth installations).
If the transducers are not connected directly to the Trumpet , a
new calibration procedure will be required before the
instrument is used.
Calibration of the output in free field conditions can be
considered dependable as long as the acoustic properties of the
surroundings are not altered significantly. If this condition
cannot be maintained, or the instrument is moved, a fresh
calibration procedure will be required.

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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.
1.4.3 Hygiene and infections
The earpieces of ER-3C earphones are disposable; do not use
the same earpiece for different patients. Dispose of earpieces
after use.
Disinfect the cushions of headphones between one patient and
the next, otherwise there is the risk that infections could be
passed on.
The silicone tubes connected to the microphone of REM probes
are disposable; do not use the same tubes for different patients,
as there is the risk that infections could be passed on. Dispose
of tubes after use.
Probe tubes can be reused for the same patient: clean using a
cloth moistened lightly with alcohol before inserting into the
ear. Check also that there are no obstructions internally of the
tube: if the bore is not completely clear, use a new tube.
Use only biocompatible silicone tubes supplied by Inventis srl.
An ear inspection must always be performed before inserting
the probe tube, to make certain that the auditory canal is free of
any obstruction caused by accumulations of wax, and that there
is no inflammation or possible infection.
1.4.4 Avoiding discomfort for the patient
The Trumpet is capable of generating pure tones at an intensity potentially
harmful to the patient (up to 90-100 dB SPL). Take particular care over the
intensity of the tone before presenting it: studies have shown that exposure
to a sound reaching the auditory canal at an intensity greater than or equal to
85 dB SPL for more than 7 hours can result in damage to hearing, but if

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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). At all events, the software
includes an option for checking that UCL (UnComfortable loudness Level)
values attributed to the patient are not exceeded for a given length of time,
which interrupts the sound output if such a situation should occur (refer to
Maestro –Fitting and hearing aid test functionalities –User Manual for
directions on how to enable or disable this option). If the user has an
audiometer license, it is possible to determine the UCL thresholds for the
patient (refer to Maestro –Impedance audiometry functionalities - User
manual).
During the course of an audiometry test, the system will prompt for further
confirmation before the intensity of the sound emitted can be increased to a
level higher than 100 dB HL.
When conducting REM tests at high levels, used to verify the limits of the
hearing aid (as in the case of MPO), the duration of the emission must not
exceed 15 seconds.
It is important to remain watchful for any adverse reaction of the patient, so
that action can be taken swiftly if clear signs of discomfort or pain are
shown during the course of the test, either interrupting the signal at source
or distancing the transducer from the test area.
1.6 DISPOSAL
Like any other electronic device, the Trumpet contains certain extremely
hazardous substances such as cadmium or mercury, albeit in extremely
small proportions. If released into the normal refuse collection system
without suitable preliminary treatment, these substances can cause serious
damage to the environment and to health. At the end of its service life,
accordingly, each component of the device must go through a sorted
collection process.
This means that the user should deliver (or despatch) waste items to the
sorted collection centres set up by local authorities, or alternatively, hand
them back to the dealer when purchasing a new appliance of the same or
similar type.

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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. is a company certified to ISO 13485.
1.8 FCC/ISED USE RESTRICTIONS AND WARNINGS
With reference to:
FCC ID: 2AVOO-RE1RA
IC: 25857-RE1RA
HVINs: Trumpet REM & AUD Wireless, Trumpet REM, Trumpet AUD,
Trumpet REM & AUD, Trumpet REM Wireless
and
FCC ID: 2AVOO-RE1RAWP
IC: 25857-RE1RAWP
HVIN: WPROBE
Changes or modifications not expressly approved by the party responsible
for compliance could void the user's authority to operate the equipment.
This device complies with part 15 of the FCC Rules. Operation is subject to
the following two conditions: (1) This device may not cause harmful
interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation.
This equipment has been tested and found to comply with the limits for a
Class B digital device, pursuant to part 15 of the FCC Rules. These limits
are designed to provide reasonable protection against harmful interference
in a residential installation. This equipment generates, uses and can radiate
radio frequency energy and, if not installed and used in accordance with the

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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.
•Increase the separation between the equipment and receiver.
•Connect the equipment into an outlet on a circuit different from
that to which the receiver is connected.
•Consult the dealer or an experienced radio/TV technician for help.
Responsible party’s contact located in the Canada:
Canadian Certification Consulting, Inc.
2210 Horizon Drive, Suite 17
West Kelowna, BC V1Z 3L4
Tel. No.: 1-250-575-1719
E-mail: [e-mail]
This device contains license-exempt transmitter(s)/receiver(s) that comply
with Innovation, Science and Economic Development Canada’s license
exempt RSS(s). Operation is subject to the following two conditions: (1)
This device may not cause interference. (2) This device must accept any
interference, including interference that may cause undesired operation of
the device.
L’emetteur/recepteur exempt de licence contenu dans le present appareil est
conforme aux CNR d’Innovation, Sciences et Developpement economique
Canada applicables aux appareils radio exempts de licence. L’exploitation
est autorisee aux deux conditions suivantes: (1) L’appareil ne doit pas
produire de brouillage; (2) L’appareil doit accepter tout brouillage
radioelectrique subi, meme si le brouillage est susceptible d’en
compromettre le fonctionnement.
ICES-003 Class B Notice -Avis NMB-003 Classe B:
This Class B digital device complies with Canadian ICES-003
Cet appareil numerique classe B est conforme à la norme Canadien NMB-
003.
CAN ICES-3(B) /NMB-3(B)

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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.
Device with applied parts, Type B (EN60601-1)
Mark indicating conformity with Council Directive 93/42/EEC
concerning medical devices (as amended and expanded by
Directive 2007/47/EC) –Class IIa device, notified body 0123 (TÜV
SÜD Product Service GmbH).
IP20
IP (Ingress Protection) code: this device is protected against the
penetration of objects larger than 12.5 mm; it is not protected
against the penetration of liquids.
Rx only
Warning: under US federal law, the device can only be sold
through or on the instruction of authorized healthcare
professionals.
MODEL
Model of the device
REF
Catalogue code
Serial number of the appliance. The number is made up of 13
alphanumeric characters indicating the model, series, year of
manufacture and serial number. In particular, the number
comprises these segments:
-first 5 characters: Inventis product code
-characters 6 and 7: year of manufacture ("16" denotes 2016)
-character 8: model series
-characters 9-13: pro serial number
UDI code
SN

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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.
At least one of the two modules (REM or audiometer) is purchased together
with the instrument, with the option of integrating both at a later date by
purchasing the relative licence.
The instrument is controlled by way of the Maestro application, which can
be installed only on a Windows PC.
The following table summarizes the tests that are available with the REM
module of the Trumpet:
Measurements
Inputs
Outputs
Standard/advanced
Real Ear
Measurements
Prerecorded files PN,
WN, ISTS, ICRA
Built-in speaker
LIVE measurements
Prerecorded files PN,
WN, ISTS, ICRA, live
speech
Built-in speaker

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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
Channel
Inputs
Outputs
PURE TONE
AUDIOMETRY
Ch. 1
Pure tone, warble,
NBN
AC, BC, FF
Ch. 2
NBN, WN
AC, BC, FF
AUTO-
THRESHOLD
Ch. 1
Pure tone
AC
SPEECH
AUDIOMETRY
Ch. 1
MIC, (USB1,
USB2)
AC, BC, FF
Ch. 2
SN, WN, MIC
(USB1, USB2)
AC, BC, FF
MASTER
HEARING AID
Ch. 1
MIC, (USB1,
USB2)
AC
Ch. 2
MIC, (USB1,
USB2)
AC
Optional tests
QuickSIN
Ch. 1
Pure tone, warble
AC, FF
Ch. 2
NBN
AC, FF
If the power adapter of the Trumpet is disconnected during an audiometry
exam, only AC (Air Conduction) and BC (Bone Conduction) modes remain
enabled, whereas FF (Free Field) mode is disabled. To enable free field
mode, the power adapter must be reconnected (see Chapter 3 Installation).
If the instrument is powered up only by way of the USB cable, the
maximum limits of the enabled outputs will be reduced by 10 dB.

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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.
REM version
Trumpet unit
•
Wired REM probes
•
Set of probe parts (includes probe tubes, insertion guides and
spare O-rings)
•
USB cable
•
Monitor headphones with microphone
•
Medical grade power adapter 15V/2A
•
Inventis Software Suite
•
Operator Manuals
•
RECD unit
opt.
Wireless REM version
Trumpet unit
•
Wireless REM probes
•
Set of probe parts (includes probe tubes, insertion guides and
spare O-rings)
•
USB cable
•
Monitor headphones with microphone
•
Medical grade power adapter 15V/2A
•
Inventis Software Suite
•

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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.
Set of connectors for external speakers
•
Bone vibrator B71
•
Patient response button
•
Monitor headphones with microphone
•
Clip-on talk-back microphone
•
Inventis Software Suite
•
USB cable
•
Medical grade power adapter 15V/2A
•
Operator Manuals
•
Compatibility has been verified only with transducers and
accessories supplied by Inventis S.r.l. Do not use other
transducers or accessories.