TRUMPET

REAL EAR MEASUREMENT SYSTEM

AUDIOMETER

USER MANUAL
 Read thoroughly this manual before using the device. Pay
particular attention to Chapter 1 (“Safety: warnings and
information”) and Chapter 3 (“Installation”)

Only authorised personnel are allowed to perform internal

inspections and repairs.

Copyright: Inventis srl has the copyright on this manual. It may not be
copied, reproduced or altered, in total or in any part, without the written
specific authorization from Inventis srl.

Inventis ® is a trademark of Inventis srl.

Inventis srl
Corso Stati Uniti, 1/3
35127 Padova
Tel.: 049.8962844
Fax: 049.8966343
www.inventis.it
info@inventis.it

Revision: 10
Date: 24/11/2017

ii
 Summary

Summary .......................................................................................... iii

CHAPTER 1 Safety: warnings and information ............................. 1
1.1 User manual ..................................................................... 1
1.2 Operator responsibilities ................................................ 1
1.3 Intended use ..................................................................... 2
1.4 Precautions ...................................................................... 2
1.5 Disposal ............................................................................ 6
1.6 Conformity ....................................................................... 6
1.7 Symbols on labels ............................................................ 7
CHAPTER 2 Introduction................................................................ 9
2.1 Product description ......................................................... 9
2.2 Included parts ................................................................ 11
2.3 Prepare the patient for a REM exam .......................... 14
CHAPTER 3 Installation ............................................................... 23
3.1 Connections.................................................................... 23
CHAPTER 4 Maintenance ............................................................. 31
4.1 REM probes calibration and equalization .................. 31
4.2 Periodic checks .............................................................. 32
4.3 Transducers cleaning and maintenance ...................... 32
4.4 Replaceable parts .......................................................... 33
4.5 Repairs and technical assistance .................................. 33
4.6 Enable new licenses ....................................................... 34

iii
 4.7 Firmware upgrade ........................................................ 35
4.8 Microphone calibration through code ......................... 35
APPENDIX A: Technical specifications ....................................... 37
REM technical specifications .......................................................... 37
Audiometer technical specifications ............................................... 39
Other specifications ......................................................................... 44
APPENDIX B: Specifications of speakers for free field ............... 49
APPENDIX C: Troubleshooting.................................................... 51
APPENDIX D: Electromagnetic emissions ................................... 55

iv
 CHAPTER 1

Safety: warnings and information

1.1 USER MANUAL

We recommend that you thoroughly read this manual in order to obtain
maximum efficiency and safety from your Trumpet device. It is particularly
important that you read this chapter in its entirety. It contains essential
warnings and important information on the safe and correct use of the
instrument.
In this manual, the safety symbol shown below draws your attention to
information that is particularly important for safe and correct use.

1.2 OPERATOR RESPONSIBILITIES

Trumpet is guaranteed to efficiently and reliably work only if used
according to the instructions and procedures given in this manual.
In the event that the instrument develops a malfunction or requires repair,
disconnect it from the main electrical supply and do not use it again until
the necessary repairs and servicing have been completed. Defective and
malfunctioning parts must be replaced only with original spare parts
supplied by Inventis srl. All repairs must be performed exclusively by
Inventis or by personnel authorized by Inventis.
No part of the instrument may be modified or replaced without Inventis
prior written authorization.

1
Users are entirely responsible for any malfunction caused by improper use,
or by maintenance or repair operations performed by any party other than
Inventis srl or an authorised Service Centre. Inventis srl and its Service
Centres accept responsibility for the performance and reliability of the
instrument only if:
1. all connections, adjustments, modifications, and repairs are
performed exclusively by personnel authorized by Inventis;
2. electrical power supply and ground connections comply with the
applicable standards for electro-medical devices.

1.3 INTENDED USE

Trumpet is designed to be used only by audiology specialists in conducting
both Real Ear Measurement (REM) tests, and pure-tone and speech
audiometry tests.
The tests must be conducted in a quiet environment, in accordance with
British Society of Audiology (BSA) recommended procedures or other
national guidelines.
Trumpet is designed to be used only by people with a detailed knowledge of
the procedures involved in conducting a REM and an audiometric test; the
operator must therefore be either an audiologist (or a technician with
knowledge and experience of audiometry) or a doctor in possession of
specific skills (audiology specialist or occupational physician).

1.4 PRECAUTIONS
To ensure correct and safe use of the instrument, the following precautions
must be observed.

1.4.1 Installation and general precautions

Make sure that the required enviromental conditions are

guaranteed (during transport, storage, and operation).

Trumpet will not be protected if exposed to flammable

anaesthetic gases or similar products. Risk of explosion.

2
Avoid installing and using Trumpet close to any sources of
strong electromagnetic field, which could interfere with the
device operation.

Use only original accessories supplied by Inventis srl, unless

specifically stated otherwise.

Use only power supply provided by Inventis srl.

Trumpet is a medical device: if connected to a computer (or to

any external device) located within the “patient area” (as
defined in EN 60601-1-1), the computer (or the external device)
must be either a medical device, or protected by an isolating
transformer, in order to ensure that the computer (external
device) + Trumpet combination is in compliance with EN
standard 60601-1-1

In order to conduct tests under optimum acoustic conditions,

Trumpet can be used in conjunction with a soundproof booth.
Before connecting the device to a soundproof booth, check that
the connections are compatible with the specifications
prescribed for each connector.

Trumpet was tested within the following environmental

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 was designed and is intended to be placed on a

desk or on a compatible stand.

Trumpet needs special precautions regarding EMC and needs to

be installed and put into service according to the EMC
information provided in Appendix D.

Use of portable and mobile RF communications equipment can

affect the correct operation of Trumpet device. Make reference
to the EMC information in the Appendix D.

3
1.4.2 Calibration
The calibration of the audiometer and of the REM probes are
valid only for those transducers that have been supplied with the
device. If a transducer is replaced, the device must be
recalibrated.
The calibration of the audiometer and of the REM probes are
valid for transducers supplied with the device, 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 device, a new
calibration procedure will be required before the instrument is
used.
The calibration of the FF output remains valid until the
environment acoustic properties do not significantly change. If
they change (e.g. after the device has been moved), a new
equalization will be necessary.
For audiometric tests, when a non-calibrated transducer is
selected, the software will inform the user, who will not be able
to send any stimulus through non-calibrated transducers.
Take note of the calibration expiration date indicated for the
audiometer and the REM probes. Use of the instrument beyond
the calibration expiry date can lead to unreliable diagnoses.

1.4.3 Hygiene
The eartips for ER-3C insert earphones are disposable; do not
use the same eartip for different patients. Dispose of eartips
after use.

Cushions of headphones should be disinfected according to

local guidelines.
The silicone tubes used in the REM probes are disposable; do
not use the same tubes for different patients. Dispose of tubes
after use.
When testing the same patient, it is possible to reuse the same
silicone tubes. Before proceeding with the probe tube insertion,
clean them with an alcohol-soaked cloth, checking that they are
free from obstructions. Use new probe tubes otherwise.

4
 Use only biocompatible silicone tubes provided by Inventis srl.

Always perform an otoscopy before inserting the probe tubes.

This allows checking the ear canal is free from obstructions and
from inflammations.

1.4.4 Avoid patient discomfort

Trumpet can generate sounds at an intensity potentially damaging to the
patient (i.e., up to 90 – 100 dB SPL). Take particular care to correctly set
the intensity of the sound before presenting it: it has been demonstrated that
extended exposures (i.e., longer than 7 hours) to noises that reach 85 dB
SPL can cause permanent damage to the hair cells in the inner ear. If this
level is further amplified by the ear canal, 30 seconds of exposure are
sufficient to report an equivalent damage.
In order to avoid risks when performing a REM test, make sure that the
hearing aid thresholds have been correctly set. If necessary, check the MPO
(Maximum Power Output) by using the relative feature in Maestro software
(cfr Maestro - Fitting and hearing aid test functionalities – User manual).
The software provides an option which allows the operator to check that the
presented sound is not exceeding the patient’s UCL (UnComfortable
loudness Level). The sound emission is stopped otherwise (cfr Maestro -
Fitting and hearing aid test functionalities – User manual to see how to
enable / disable this option). If the audiometer license is activated in
Trumpet, the operator can use it to determine the patient’s UCL (cfr
Maestro - Impedance-audiometry functionalities – User manual).
During an audiometric exam, a confirmation is required in order to increase
the emitted sound over 100 dB HL.
In REM tests where high levels are used in order to verify the hearing aid
thresholds (i.e. if checking the MPO), the sound emission must be shorter
than 15 s.
It is necessary to constantly monitor the patient’s reactions, in order to be
ready to intervene if he/she shows discomfort or pain during the exam. In
this case, stop the exam or move the patient away from the test area.

5
1.5 DISPOSAL
Like all electronic devices, Trumpet contains extremely small quantities of
certain hazardous substances such as cadmium or mercury. If such
substances are allowed to enter the normal waste disposal cycle without
suitable preliminary treatment, they can cause damage to the environment
and to health. All parts of the device must therefore be disposed of
separately.

At the end of its life, take (or have taken) the disused instrument to a civic
waste disposal and recycling facility, or return it to the reseller against the
purchase of an equivalent new instrument.

Separate waste collection and subsequent operations of treatment, recycling

and disposal facilitate the manufacture of new devices from recycled
materials, limiting any negative impact on the environment and on public
health.

1.6 CONFORMITY
The Inventis Trumpet is a class IIa medical device, according to Annex IX
of Medical Device Directive (MDD) 93/42/EEC as amended by
2007/47/EC directive.
Inventis srl is certified ISO 9001 and ISO 13485.

6
1.7 SYMBOLS ON LABELS

Name and address of the manufacturer.

Caution: specific warnings or precautions are associated with this

device; consult the attached documents for a safe use.

Consult user manual.

This symbol means this product is covered by the Directive

2012/19/EU on waste electrical and electronic equipment (WEEE).
It is required not to dispose this product as unsorted municipal
waste, but to collect it separately.
Device with applied parts of type B (EN60601-1)

Product conforms to European Community Medical Device

Directive (MMD) 93/42/EEC, as amended by 2007/47/EC
directive. Class IIa device; number of notified body: 0123 (TÜV
SÜD Product Service GmbH).
IP (Ingress Protection) Code: this device is protected against the
IP20
access of objects sized > 12.5 mm, not protected against liquid.
Caution: Federal Law (USA) restricts this device to sale by or on
Rx only
the order of a licensed healthcare practitioner.
MODEL Device model.
REF Catalogue number
Device serial number. 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
SN - characters 6 and 7: year of manufacture (“16” denotes 2016)
- character 8: model series
- characters 9-13: serial number

UDI code

7
 CHAPTER 2

Introduction

2.1 PRODUCT DESCRIPTION

Trumpet is a Real Ear Measurement (REM) system capable of assessing all
the in-situ parameters required for a complete hearing aid fitting process. It
is characterized by a small and light in-situ probe headset, and by a
powerful built-in speaker.
Trumpet features also a diagnostic audiometer capable of performing pure
tone and speech audiometry exams, both in air, free field, and in bone
conduction.
At least one of the two modules (either REM or Audiometry) are bought
together with Trumpet. If desired, the second module can be integrated in a
second moment, after buying the relative license.
Trumpet is controlled by the Maestro application, running on Windows PC.
The following table indicates the types of tests available on Trumpet REM:

Measure Input Output

REM standard and PN, WN, ISTS, ICRA, Embedded

advanced measures personal files loudspeaker

PN, WN, ISTS, ICRA, Embedded

LIVE measure
personal files, live speech loudspeaker

During a REM test, Trumpet can be used only with Free Field (FF) output
and it is necessary to ensure the power supply is plugged in (cfr Chapter 3
Installation).

9
The following table summarizes the types of tests available in audiometry
mode.

Exam Channel Input Output

Pure tone, warble,
PURE TONE Ch. 1 AC, BC, FF
NBN
AUDIOMETRY
Ch. 2 NBN, WN AC, BC, FF
AUTO-
Ch. 1 Pure tone AC
THRESHOLD
MIC, (USB1,
Ch. 1 AC, BC, FF
SPEECH USB2)
AUDIOMETRY SN, WN, MIC
Ch. 2 AC, BC, FF
(USB1, USB2)
MIC, (USB1,
Ch. 1 AC
MASTER USB2)
HEARING AID MIC, (USB1,
Ch. 2 AC
USB2)
Optional exams
Ch. 1 Pure tone, warble AC, FF
QuickSIN
Ch. 2 NBN AC, FF

If during an audiometric exam Trumpet power supply is unplugged, only

the Air Conduction (AC) and the Bone Conduction (BC) output are enabled.
The Free Field (FF) output is disabled. In order to enable it, it is necessary
to plug the power supply in (cfr Chapter 3 Installation). If the device is
powered via USB cable only then the maximum limits of the available
outputs are reduced by 10 dB.

10
2.2 INCLUDED PARTS
According to the module that has been bought together with Trumpet,
Inventis supplies the device with either all the following accessories or a
subset of them. If an additional license is bought in a second moment,
Inventis will supply all the related accessories (unless already included in
the previously bought license).

The following table indicates the parts included with Trumpet, according to
the chosen license

REM license

Trumpet unit •
REM probe headset •
Set of probe spares (includes silicone tubes, probe tube guides
and o-rings) •
USB cable •
Monitor headset with boom microphone •
Patient headset •
Medical 15V/2A power supply •
Inventis Software Suite •
User manuals •
RECD box opt.

Audiometry license

Trumpet unit •
Supra-aural headset (Radioear DD45 or Telephonics TDH-39) •
Insert earphones (Etymotics ER-3C) opt.

Amplivox Audiocups noise excluding enclosures opt.

11
 B71 bone vibrator •
Set of connectors for external loudspeakers •
Patient response switch •
Monitor headset with boom microphone •
Clip-on microphone for patient-to-operator communication •
Inventis Software Suite •
USB cable •
Medical 15V/2A power supply •
User manuals •

Only the compatibility of transducers and parts provided by

Inventis SRL were verified. Do not use other transducers or
parts.

12
2.2.1 REM probes
Two probes are located at the extremities of the bow. In this paragraph, a
thorough description is provided.

F G
A

D E
B C

A. Probe tube slot E. Graduation

B. Probe tube F. Probe tube insertion guide slot
C. O-ring G. Probe tube calibration guides
D. Reference microphone

If possible, it is recommended to place the REM probes in their

bow while using them.

Probe tube insertion

A set of probe tubes is provided together with Trumpet (REM license). In

order to insert a probe tube, place the blue coloured part of the tube on the
metallic cylinder that represents the probe tube slot (A in figure), then
gently push until a complete insertion is reached.

Be careful with the probe tube insertion: the microphone probe

might be damaged by a forced insertion.

2.2.2 In use loudspeaker equalization (REM)

In order to perform the loudspeaker equalization, place the bow in front of
the loudspeaker, approximately at the same distance and position in which

13
the patient’s head will be placed during the REM exam. For better results, it
is recommended to apply the bow to the patient before performing the
equalization. An approximate distance of 1 meter is an optimal choice for
both the equalization and the exam.
Be sure that the microphones are free from obstructions (e.g. hairs).
For any further information regarding the equalization procedure, cfr
Maestro - Fitting and hearing aid test functionalities – User manual.

2.2.3 Probe tube calibration (REM)

In order to perform microphone probe calibration, the proper setup is shown
below (for any further information regarding the calibration procedure, cfr
Maestro - Fitting and hearing aid test functionalities – User manual.). The
probe tube tip must be inserted in one of the specific guides. Be careful to
place the tip as close as possible to the reference microphone. Then place
the bow in front of the loudspeaker, at an approximate distance of 1 meter.

2.3 PREPARE THE PATIENT FOR A REM EXAM

Only audiologists (or technicians with knowledge and experience of
audiometry) or doctors in possession of specific skills (audiology
specialist or occupational physician) can perform a REM test. If
performed by non-qualified/authorized personnel, the exam might
cause acoustic damage to the patient.

Use new probe tubes for each patient. The use of the same probe
tube with different patients might cause infection dissemination.

14
 Do not force the probe tube insertion in the patient’s ear canal: you
might cause eardrum perforation. In order to determine the most
proper insertion depth, use the reference rule in the bow.
Obstruction in the ear canal might prevent the execution of the
REM test. In order to avoid the presence of obstruction, always
perform an otoscopy before proceeding with a REM exam.

2.3.1 Measure a real ear response

In order to prepare a patient for the REM exam, comply with the following
procedure:

1. Place the patient in front of the loudspeaker, at an approximate

distance of 1 meter, in order to have his/her ears in line with the
device.
2. Move the probe tube back ring in order to have it at the desired
insertion length (the ruler in the bow can be of help, as shown in
the picture). Recommended distances are:
a. Males: 27 mm
b. Females: 27 mm
c. Children: 20-25 mm

NOTE: insertion lengths might vary among patients. We

recommend performing an otoscopy in order to have a correct idea
of the ear canal dimensions.

15
 3. Have the patient wear the headset probe, adjusting the o-rings so
that the probe is just below the earlobe.
4. Carefully insert the probe tube in the patient’s ear canal, until its
black ring reaches the inter-tragus notch. Do not force insertion.
In order facilitate the correct insertion of the probe tube, and to
avoid having it stuck in the ear canal, the operator can use the
provided guides. Insert the guide in the specific hole (for any
further information, see Paragraph 2.2.1 REM probes) and the tube
as shown in the explanatory picture. This procedure allows
avoiding any bending of the tube during the insertion in the ear
canal.

5. Measures such as REAR require the insertion of the hearing aid in

the patient’s ear canal. In this case, insert the hearing aid in the ear
canal, carefully checking that it does not occlude the probe tube.
Besides, check that the probe tube does not change its position.

The following picture shows the correct positioning of the bow and of the
tube:

16
 It is extremely important to properly calibrate the microphone
probes each time a new tube is used. Erroneous or missing
calibrations might condition the measures and lead to incorrect
results.

If possible, it is recommended to place the REM probes in their

bow while using them.

2.3.2 Measure a coupler response

17
When it is not possible to perform an entire REM test with a cooperative
patient, measures can be performed in coupler with an RECD box.
Before proceeding with the exam, the equalization of the RECD
loudspeaker and the calibration of its microphones are mandatory, and can
be performed placing the coupler microphone in front of the reference
microphone, on the RECD loudspeaker, as shown in the following figure.
For further details, see Maestro - Fitting and hearing aid test functionalities
– User manual, Paragraph In coupler measurements.

In order to correctly connect the coupler with different types of hearing aids
(e.g., BTE, ITE, CIC, …), several adapters are provided. They can be seen
in the following picture.

18
 1 2

- Adapter (1) shall be used for ITE, ITC, and CIC hearing aids, and for
BTE hearing aids with thin tube instead of ear hook. In order to
properly couple the hearing aid to the adapter, the use of an acoustic
putty is recommended
- Adapter (2) allows connecting the 2cc coupler to BTE hearing aids
through an ear hook
- Adapter (3) shall be used for both RIC hearing. The use of the acoustic
putty is recommended.
- An additional, optional adapter shall be used in case of body worn
hearing aids.

As soon as the hearing aid has been properly connected to the coupler, the
operator shall position it on the RECD box, so that
- hearing aid microphone is perpendicular to the RECD box speaker
- reference microphone of the RECD box is as close as possible to the
hearing aid microphone.
Please see an example of a correct setting in the following picture.

19
Before starting the fitting procedure with the RECD box, the operator shall
acquire an RECD curve, so that each measure acquired in coupler can be
properly converted into a measured acquired in ear.
The software allows performing the fitting procedure in coupler only if an
RECD curve has been acquired.
The acquisition of the RECD curve is performed in two steps: one measure
shall be acquired in ear, and one in coupler. In particular, in order to
perform a measure in ear, after having inserted the probe tube in the ear
canal of the patient as described in Paragraph 2.3.1, the operator shall put
the insert earphones in the ear canal. This operation shall be carefully
performed, in order not to move the probe tube from its position. An
example of correct placement of the probe tube and the insert earphone is
shown in the following picture

20
Once the in-ear measure has been acquired, the coupler measure can be
performed. To do so, the tube of the insert earphone shall be connected to
the coupler adapter as shown in the following picture:

As soon as both in-ear and in coupler measures have been acquired, the
RECD curve can be automatically computed. The RECD curve will be used
throughout the fitting procedure performed with the RECD box. For further
details on the use of Maestro software as far as the RECD curve acquisition
is concerned, see Maestro - Fitting and hearing aid test functionalities –
User manual, Paragraph RECD.

21
22
 CHAPTER 3

Installation

Even if the installation of Trumpet is a relatively simple procedure, it

should be entrusted to a qualified person. If the installation is not performed
correctly, the system could be affected by safety problems when in use.
This chapter describes the correct procedure for the installation of the
system.

Keep the packaging materials, in case the device needs to be sent

to the dealer or to Inventis.

3.1 CONNECTIONS

3.1.1 Rear panel

The following table reports the connectors placed on the rear panel of the
instrument.

23
Plug available transducers and components into the respective connectors as
indicated in the following table:

Connector Component

PAT. RESP Patient response switch

BC Bone vibrator

Supra-aural headphones (TDH-39 or DD45): Right

AC L and AC R
(ACR) and Left (ACL)

TALK BACK Patient microphone

Operator microphone for communication with

TALK OVER
patient

SPK L (blue) & R External loudspeaker for free field exam: right (R,
(red) red) and left (L, blue)

RECD transducers right (R) and left (L)

RECD/INSERT or
L&R insertion earphones (ER-3C) for AC: right (R) and
left (L)

RECD BOX RECD loudspeaker for coupler measurements

Patient headphones for counselling (hearing aid

CLIENT
and hearing loss simulators)

MON Monitor headphones for operator

USB USB cable for the connection to the PC

SPK (green) Reserved for future use

15V/2A
Power supply

24
Plug the power supply into its connector in the rear panel and connect the
relative power cord, which should be plugged into an AC mains socket
supplying the voltage reported on the adapter label.

All connections must be established with the device switched off,

meaning that the power cord and the USB cable are not plugged in.

Use only power supply provided by Inventis srl.

Connect the device only to medical equipment or to devices

equipped with isolation transformer.

Connect the device only to power lines with a voltage range of 100-
240 V and a frequency range of 50-60 Hz.

3.1.2 Front panel

The connector for REM probe set is placed near the bottom right corner of
Trumpet (only connector present in the front panel).

25
 Connector Component

PROBE In-situ REM probes set

Around the probe connector, a LED indicates the communication status

between Trumpet and the PC: the LED is on when the device is connected
to the controlling PC

NOTE:
In order to perform a REM test it is necessary to connect only the USB
cable and the power supply (and optionally the MON headphones) to the
rear panel, and the in-situ REM probes set to the front panel.

26
3.1.3 REM mode wiring diagram

REM probes

Patient
communication

RECD
measurements

27
 PC/Power

3.1.4 Audiometer mode wiring diagram

AC/BC
Transducer
s

28
 Free field
speakers

Option 1: External loudspeakers

Option 2: RECD loudspeaker + Trumpet integrated loudspeaker (*)
Option 3: Trumpet integrated loudspeaker only

(*) In this configuration the integrated loudspeaker is considered the left speaker and the
RECD loudspeaker the right speaker.

The involved loudspeakers must be calibrated before using any of the three options
above.
Options 1 or 2 must be enabled, during calibration, by a technician approved by Inventis
srl.

Patient
communication

29
PC/Power

3.1.5 Positioning the device

The Trumpet can be placed:
• on a table,
• mounted on a stand
• hung on a wall via a standard VESA mount (optional)
• hung on a specific wall hanger (optional), with an optional support
for the AUD transducers

To hold the Trumpet with a VESA mount it is recommended to use

M4 screws that enter into the available threaded holes not more
than 6 mm (0.236 inches)

30
 CHAPTER 4

Maintenance

Trumpet does not require any special periodic maintenance other than
calibration and normal cleaning, both described in this chapter.

Before commencing any kind of cleaning operation, the instrument

must be switched off and disconnected from the power supply and
USB.

The inspection and servicing of internal components must be

entirely performed by technicians approved by Inventis srl.
Transducers are manufactured utilizing ultra-fragile diaphragms
that could be damaged in the event of impact. Handle with care
during maintenance operations.

4.1 REM PROBES CALIBRATION AND EQUALIZATION

Reference microphone calibration must be entrusted to technicians
approved by Inventis srl. The operation should be performed at
least once every 12 months, and whenever a transducer is replaced.

Every time the environmental setup of the REM device is modified a

speaker equalization must be performed by the operator (for further
information, see “Maestro - Fitting and hearing aid test
functionalities – User manual”).

Every time the probe tube is changed, and then every time there is a
new patient, a probe tube calibration must be performed by the
operator (for further information, see “Maestro - Fitting and
hearing aid test functionalities – User manual”).

31
 In case of RECD box, reference microphone calibration must be
entrusted to technicians approved by Inventis srl. The operation
should be performed at least once every 12 months, and whenever a
coupler is replaced.

4.2 PERIODIC CHECKS

In order to maximize the life of both the device and of all of its accessories,
the following tests should be performed daily:

The tests must be performed with the instrument in its installation

position. For further information see Maestro software manuals.

- Before switching the instrument on, check that all the contacts are
perfectly connected and that the cables and/or connectors as well as all
other elements do not appear to be broken or damaged externally.

- Calibrate probe tube microphones using a new probe tube to check their
functionality.

- Check subjectively that the air conduction and bone conduction output
are equal on both channels and all frequencies. A sound level of 10 or
15 dB HL is enough to hear if the stimulus has been sent. The person
who carries out this check should have good hearing.

- Check at a level of 60dB HL in AC and 40dB HL in BC that there are

no distortions, noise or parasitic signals at any frequencies.

- Check that patient response trigger works correctly.

- Check the headband strain of headset and of bone vibrator.

- Check the communication with the patient.

4.3 TRANSDUCERS CLEANING AND MAINTENANCE

Do not use liquids or sprays to clean the device. In order to clean
the device, use a soft cloth moistened with mild detergent.

The headphone earpads and the bone vibrator are made of biocompatible
material but are not sterile. To avoid the spread of infections it is necessary

32
to disinfect them before using them on a new patient, using hypoallergenic
disinfectants and follow the producer’s instructions.

The earpieces of insert earphones are made of biocompatible material and

disposable: use once only and dispose of in accordance with current health
and safety regulations.

Use a soft cloth moistened with a small amount of non-caustic medical

grade disinfectant to clean the parts of the bow in contact with the patients
(i.e. o-rings and rear probe shells).

Keep the device and the microphones away from liquids

Do not allow moisture inside the unit. Moisture inside the unit can
damage the instrument and it may result in a risk of electrical shock
to the user or patient.
The earpieces of insert earphones are not sterile. The use of
unsterilized earpieces can cause ear infections.
The silicone probe tubes are intended for single use only. Do not
clean or re-use them.
No part of Trumpet or its accessories is suitable for autoclaving or
thermal disinfection/sterilization methods.

4.4 REPLACEABLE PARTS

The transducers and accessories can be disconnected from the device.
Should a fault develop in any one of these devices, the device must be
switched off and isolated from the power supply, and the defective item
must be disconnected from the device

All accessories of Trumpet are specifically designed for use with the
device. Only accessories supplied by Inventis should be connected
to Trumpet..

4.5 REPAIRS AND TECHNICAL ASSISTANCE

Before contacting the service department, make certain that all the possible
solutions in the “Troubleshooting” section (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.

33
If the instrument needs to be shipped back to Inventis service department or
returned to the dealer, it is important that the original packing is used, and
that all accessories and transducers are enclosed.
Contact the dealer or Inventis service department before shipping it back. In
most cases it is possible to solve the problem without shipping your unit
back.

4.6 ENABLE NEW LICENSES

When a new license key is purchased from Inventis, this can be used to
enable new functionalities of the Trumpet system. The “Licenses Activation
Tool” software that is needed to enable the license can be found in Maestro
installation folder, under path Service/Trumpet/LicensesActivationTool.
Be sure to have the license key available. Connect Trumpet to the PC with
the USB cable provided and plug the adapter into the mains power socket
(for more information, consult chapter 3 of the Trumpet - User Manual).
Close Maestro and any other programs using the device, and go to Maestro
installation drive or .zip file build and copy on your PC the file
Extras\Service\Trumpet\RE1LicensesActivationTool.zip. Unzip this folder
and open the program RE1LicensesActivationTool.exe. The following
window will appear:

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

34
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. If a message appears warning that the key is not valid,
check that it has been entered correctly. Remember that for licenses to be
enabled, the device must be connected to the computer by way of the USB
cable provided.

If there is no doubt that the key has been entered correctly and the
license still cannot be enabled, contact Inventis customer service.

4.7 FIRMWARE UPGRADE

The firmware upgrade is described in Maestro - Fitting and hearing aid test
functionalities – User manual, and can be performed using software
“Firmware Upgrader” that can be found in Maestro installation folder under
Service/Trumpet/FirmwareUpgrader.

4.8 MICROPHONE CALIBRATION THROUGH CODE

The calibration of the REM probe reference microphones, or of the RECD
coupler mic, through a calibration code, is described in Maestro - Fitting
and hearing aid test functionalities – User manual, and can be performed
using the Maestro software.

35
36
 APPENDIX A:

Technical specifications

REM technical specifications

REM Classification
Class 2A Real Ear Measurement system (MDD 93/42)

REM GENERAL SPECIFICATIONS

Frequency range 125 Hz – 12 kHz

Reference microphones
40 – 110 dB SPL
measurement range
Probe microphones
40 – 130 dB SPL
measurement range
1 m stimulus intensity 50 dB SPL – 90 dB SPL, 5 dB step (+/- 3 dB)
Modified Pressure Method with Concurrent
Equalization method
Equalization (Stored Equalization for open fitting)
Analysis 1/3 – 1/24 octave bands (user-definable)
Silicon: 1mm nominal diameter, 80 mm nominal
Probe tubes
length

REM AVAILABLE SIGNALS

Type
ICRA •
ISTS •
Live speech •
Custom files •
Pink Noise (PN) •
White Noise (WN) •

37
 REM AVAILABLE MEASUREMENTS
REUR / REUG •
REOR / REOG •
REAR / REAG / REIG •
RECD opt
MPO •
Advanced •
Live •

AVAILABLE FITTING RULES

NAL-NL1 •
NAL-NL2 •
DSL V5 •

REM AVAILABLE OUTPUTS AND TRANSDUCERS

In situ REM probes •
Insertion transducers for RECD •
Integrated loudspeaker (free field) •
Coupler base (opt) •

38
 Audiometer technical specifications

Audiometer Classification
Type 2 Pure Tone Audiometer (EN 60645-1, ANSI S3.6)
Type A Speech Audiometer (EN 60645-2, ANSI S3.6)

AUDIOMETRY AVAILABLE SIGNALS

Type
Pure tone •
Warble tone •
MIC input for speech audiometry (live speech) •
Narrow Band Noise (NBN) •
White Noise (WN) •
Speech Noise (SN) •

AVAILABLE AUDIOMETRIC TESTS

Pure Tone Audiometry •
Autothreshold •
Speech Audiometry •
Master Hearing Aid •
QuickSIN opt

AUDIOMETRY AVAILABLE OUTPUTS

Output
Air conduction ( DD45 or TDH-39 headphones) •
Air conduction (ER-3C insert earphones) •
Bone conduction (B-71 bone vibrator) •
Free field (embedded loudspeaker, passive external loudspeakers) •

39
 PURE AND WARBLE TONE
AVAILABLE FREQUENCIES AND MAXIMUM
INTENSITIES
AC
AC FF FF
Freq. TDH39 BC1
ER-3C1 Int. 2 Est. 2
(Hz) DD451 (dB HL)
(dB HL) (dB HL) (dB HL)
(dB HL)
125 80 90 - 60 65
250 100 105 45 75 80
500 110 110 65 85 90
750 115 115 70 85 90
1,000 120 120 75 85 90
1,500 120 120 80 85 90
2,000 120 120 80 85 90
3,000 120 120 75 85 90
4,000 120 110 75 85 90
6,000 105 100 55 85 90
8,000 95 90 50 75 80

SPEECH AUDIOMETRY
MAXIMUM INTENSITIES
AC AC AC FF FF
BC1
TDH-391 DD451 ER-3C1 Int. 2 Est. 2
(dB HL)
(dB HL) (dB HL) (dB HL) (dB HL) (dB HL)

100 100 100 55 70 80

40
 NBN, WN AND SN MASKING
AVAILABLE FREQUENCIES AND MAXIMUM INTENSITIES

AC AC AC FF FF
Freq. BC1
TDH391 DD451 ER-3C1 Int. 2 Est. 2
(Hz) (dB FL)
(dB EM) (dB EM) (dB EM) (dB HL) (dB HL)
125 60 60 70 - 55 60
250 80 80 85 105 60 65
500 95 95 95 110 75 80
750 100 100 100 110 80 85
1,000 105 105 105 110 80 85
1,500 105 105 105 110 80 85
2,000 105 105 105 110 80 85
3,000 105 105 105 100 80 85
4,000 105 105 100 100 80 85
6,000 100 100 90 90 75 80
8,000 90 90 80 80 65 70
90 90 80 45 70 75
WN
dB EM dB EM dB EM dB EM dB HL dB HL
90 90 80 45 70 75
SN
dB EM dB EM dB EM dB EM dB HL dB HL

(1) When the device is powered via USB only, the reported maximum values have to
be decreased by 10 dB
(2) When the device is powered via USB only, the FF outputs are disabled

41
 COMPATIBLE TRANSDUCERS
Type Manufacturer Model Impedance
Supra-aural
Telephonics Corp. TDH39 10 ohm (1 kHz)
headphones
Supra-aural
Radioear Corp. DD45 10 ohm (1 kHz)
headphones
Insert earphones Etymotic Research Inc. ER-3C 10 ohm (1 kHz)
Bone vibrator Radioear Corp. B71 10 ohm (1 kHz)

AMBIENT NOISE ATTENUATION VALUES FOR DIFFERENT TRANSDUCERS

TDH 39 /
DD45 ER 3A/3C
Freq
with MX41\AR or PN
51 cushion
[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 39.5
6000 - -
8000 24 43.5

42
 REFERENCE EQUIVALENT THRESHOLD LEVELS

Freq TDH 39 DD45 ER 3C B71* FF

ISO 389-1 Vendor Tech. ISO 389-2 ISO 389-3 ISO 389-7
(ANSI S3.6) Specifications (ANSI S3.6) (ANSI S3.6) (ANSI S3.6)

[dB [dB [dB [dB [dB

[Hz]
re 20 µPa] re 20 µPa] re 20 µPa] re 1 µN] re 20 µPa]

125 45 47.5 26 - 22.1

250 25.5 27 14 67 11.4
500 11.5 13 5.5 58 4.4
750 7.5 (8) 6.5 2 48.5 2.4
1000 7 6 0 42.5 2.4
1500 6.5 8 2 36.5 2.4
2000 9 8 3 31 -1.3
3000 10 8 3.5 30 -5.8
4000 9.5 9 5.5 35.5 -5.4
6000 15.5 20.5 2 40 4.3
8000 13 12 0 40 12.6

(*) Calibration of bone vibrator (B71) refers to mastoid placement.

The reference norms are : ISO 389-1:2000, ISO 389-2:1997, ISO 389-3:1999, ISO 389-5:2007, ISO 389-8:2004,
ISO 389-7:2006 and ANSI S3.6:2010.

43
 REFERENCE EQUIVALENT THRESHOLD LEVEL FOR SPEECH
IEC 60645-2 1997
TDH39 DD45 ER3 C B71 Free Field
Coupler: ANSI S3.7-1995 (NBS-9A) /
IEC 60318-5 IEC 60373
IEC 60318-3 1998 (6ccm)
dB dB dB dB dB
[re 20 µPa] [re 20 µPa] [re 20 µPa] [re 1 µN] [re 20 µPa]
20.0 20.0 20.0 55.0 20.0
For stimulus: USB, MIC, SPEECH NOISE, WHITE NOISE

REFERENCE EQUIVALENT THRESHOLD LEVEL FOR SPEECH

ANSI S3.6 2010
TDH39 DD45 ER3 C B71 Free Field
Coupler: ANSI S3.7-1995 (NBS-9A) / refers to 0 deg
IEC 60318-5 IEC 60373
IEC 60318-3 1998 (6ccm) incidence
dB dB dB dB dB
[re 20 µPa] [re 20 µPa] [re 20 µPa] [re 1 µN] [re 20 µPa]
19.5 18.5 12.5 55.0 14.5
For stimulus: USB, MIC, SPEECH NOISE, WHITE NOISE

PATIENT – OPERATOR COMMUNICATION

Talk-over through microphone connected to the PC or to the device •
Talk back through headset connected to the PC or to the device •
Patient response trigger •

Other specifications
CONTROL OF THE DEVICE
With Inventis Maestro application installed on the PC. •
POWER SUPPLY
Consumption 30 Watt
15V, 2A cont., through an external 100-240 Vac
Power supply 50/60 Hz, power supply (included), compliant to
EN 60601-1 standard

CALIBRATION VALIDITY
Reference microphones 6-12 months
Transducers 12 months

44
 OPERATING ENVIRONMENT
Temperature: between +15°C (59°F) and +35°C (95°F)
Relative humidity: between 30% and 90% (non-
Use
condensing)
Pressure: from 700 hPa to 1060 hPa
Temperature: between -10°C (14°F) and 50°C (122°F)
Transport and storage Relative humidity: max. 90% non-condensing
Pressure: between 500 hPa and 1060 hPa
Warm-up time 1 minute

MECHANICS
Size (WxDxH) 15.5 x 10 x 24.5 cm / 6.1 x 3.9 x 9,7 in
Weight (device only) 1.5 Kg / 3.5 lbs

REAR PANEL CONNECTORS

Description Type Connector
Power supply InDC plug 2.1/5.5 mm
L and R headphones 2 jack audio 1/4” mono
Out
RECD / L and R insertion transducers 2 audio jack, 1/4” mono
Out
Bone vibrator Jack audio 1/4” mono
Out
2 connectors “Euro spring
Free field L and R (AUD) Out
clamp pluggable” type
Free field EXT (REM) (RESERVED Connector “Euro spring
Out
FOR FUTURE USE) clamp pluggable” type
Monitor headset Out Audio jack, 3.5 mm stereo
Client headset Out Audio jack, 3.5 mm stereo
RECD Loudspeaker In-out Mini DIN 6 pin
Patient response trigger In Jack audio 1/4” mono
External mic for talk-forward In Audio jack, 3.5 mm mono
Patient mic for talk back In Audio jack, 3.5 mm mono
USB In – Out USB type B
FRONT PANEL CONNECTORS
REM probes In 8 pin DIN connector

45
 ACOUSTICAL SAFETY OF THE DEVICE
Alert condition: tone intensity higher than 100 dB HL (EN
60645-1, §5.2)

Safety measures:
Audiometer
1) The operator has to press “Higher dB” button to increase
the intensity over 100 dB HL
2) Warning on the display
3) “Normally on” function disabled
Alert condition: tone intensity higher than UCL threshold or a
custom level in the range from 110 to 130 dB SPL in the ear
canal

Safety measures:
REM 1) Alert of UCL threshold exceeded and emission
interruption (if UCL threshold enabled)
2) Alert of custom value (from 110 to 130 dB SPL)
threshold in the ear canal exceeded and emission
interruption (if custom threshold enabled)
3) Alert if the control is disabled

INPUT COMPONENTS SPECIFICATIONS

Input Connector type Electrical property
Power supply DC plug 2.5mm Internal pin +15V, external pin 0V
Switches 3V to logical input (switch
Patient response Jack, 6.3mm mono current: 10mA)
Impedance: 10KΩ
RECD 6 pin DIN
-
Loudspeaker connector
Talk forward Jack, 3.5mm mono Electret or 200 Ω dynamic microphone
Impedance: 47KΩ
Talk back Jack, 3.5mm mono Freq. response: 100-12KHz +/- 3dB
Electret Bias: 2.2V through 2.2KΩ
4 omnidirectional mics Back Electret
Condenser
Impedance. 2.2KΩ
8 pin DIN
Probe REM Frequency range: 20 – 16000 Hz
connector
Nominal operating voltage: 2 V
Maximum operating voltage: 10V
Current consumption: max 0.5 mA

46
 OUTPUT TRANSDUCERS SPECIFICATIONS

Output Available Voltage Nominal impedance

TDH 39 16Vpp 10 Ω
DD45 16Vpp 10 Ω
ER 3C / RECD 16Vpp 10 Ω
B 71 16Vpp 10 Ω
Free Field (SPKF) 16Vpp 4-8 Ω
Monitor 1Vrms with 32 Ω load

AVAILABLE SIGNALS SPECIFICATIONS

True filtered random noise
WN Lower cut-off frequency: 50 Hz
Upper cut-off frequency: 20 kHz
SN As specified in EN 60645-2 §13
True filtered random noise
PN Lower cut-off frequency: 50 Hz
Upper cut-off frequency: 20 kHz
Frequency of the modulating signal: 10 Hz
Warble tone Modulation waveform: triangular wave
Modulation range: ±10%
NBN Band: ½ octave
International Speech Test Signal. See Holube, I.,
Fredelake, S., Vlaming, M. & Kollmeier, B. (2010).
ISTS Development and analysis of an international speech test
signal (ISTS). International Journal of Audiology, 49, 891-
903 for more details
International Collegium of Rehabilitative Audiology. See
ICRA
ICRA website “icra-audiology.org” for more details

47
 APPLICABILE STANDARDS
REM measurements IEC 61669:2015 / ISO 12124 / ANSI S3.46-2013
Pure Tone Audiometry EN 60645-1 / ANSI S3.6, Type 2
Speech Audiometry EN 60645-2 / ANSI S3.6, Type A
Autothreshold Modified from EN ISO 8253-1:2000
AC: EN ISO 389-1 (TDH 39),
EN ISO 389-2 (ER 3C),
Calibration vendor data (DD45)
BC: EN ISO 389-3
FF: EN ISO 389-7
Electrical saefty EN 60601-1 Class I Type B
EMC EN 60601-1-2

CE CERTIFICATE
93/42 DDM classification Class IIa
Classification rule (Annex IX,
10
93/42/EEC)
TÜV SÜD Product Service GmbH
Notified body Ridlerstrasse 65
D-80339 Műnchen
Number of the notified body 0123

48
 APPENDIX B:

Specifications of speakers for free field

In order to reach Free Field intensity values specified in Appendix A the

loudspeaker must meet the following specific requirements:

Minimum input power 25 W

Nominal impedance 4-8 Ω
Sensitivity (at 1 m for 1 W, 1 kHz) > 93 dB SPL
Passband 105 Hz – 20 kHz

49
50
 APPENDIX C:

Troubleshooting

Problem Possible cause Solution

Transducer not connected Connect the transducer to the

to the correct output correct output
No signal from a
transducer
Contact Inventis service
Damaged transducer
department or dealer

Connect the patient response

No signal from Wrong connection button to the correct
patient response connector
button when
pressed Patient response button Contact Inventis service
damaged department or dealer

Make sure the monitor

headphones are connected to
Wrong connection the correct connector,
according to the selected
No signal from
option (device or pc)
monitor
headphones
Increase the monitor volume
Monitor turned off or
using the relative slider in
headphone volume too
Maestro or turn the function
low
“Monitor” on

Patient’s voice Problems with TALK Check the connection to the

cannot be heard BACK input connection TALK BACK input

51
 TALK BACK volume too Adjust the TALK BACK
low volume control

Problems with USB

Connection Choose another USB port
connection
between PC and
device cannot be
Change the USB cable
established Damaged USB cable
(standard USB A/B cable)
REM: Reference
Calibrate the reference
microphones not
microphones
calibrated
REM: Equalization Perform a new equalization
expired or missing of the loudspeaker

REM: Probe microphones Calibrate the probe

not calibrated microphones.
Inconsistent
exam result REM: Wax in the ear Clean the ear canal, after
canal performing an otoscopy

AUD: Transducers not

Calibrate the transducers
calibrated

AUD: Wrong AC
Modify the selection of
transducer selected
current AC transducer, from
(headphones or
Maestro application
earphones)
Make sure that the probes are
correctly worn by the patient.
Probes in a wrong The patient must be placed in
Speaker position front of the device, at an
equalization approximate distance of 0.5
does not succeed m from the loudspeaker
Move the instrument in a
Background noise too
quieter room or try to reduce
loud
background noise

52
 If the problem persists,
Damaged REM reference
contact Inventis service
microphone
department or dealer

Probe tube occluded or

Change probe tube
damaged

Probe tube not correctly See Paragraph 2.2.2 Probe

inserted into his slot tube calibration

Probe tube
calibration does
not succeed Place the REM probes at an
Probes too far from
approximate distance of 0.5
loudspeaker
m from the loudspeaker

Damaged reference If the problem persists,

microphone or probe contact Inventis service
microphone department or dealer

Contact your reference

You cannot technical service to obtain the
Optional test not enabled
access a test license, communicating the
device serial number

FF output not Power supply not plugged Plug in the provided power
selectable in supply

With FF output
enabled, the Make sure that the correct
sound is not Wrong FF output configuration was selected
emitted by the configuration during the calibration
desired procedure
loudspeaker

53
 Place patient in front of the
Patient not in front of the loudspeaker, at an
Distorted sound device approximate distance of 1
emitted from meter from it
loudspeaker
Contact Inventis service
Damaged loudspeaker
department or dealer

When Trumpet is used in conjunction with a soundproof booth, check

that the connections both inside the booth and between the booth and
the instrument are correct.

54
 APPENDIX D:

Electromagnetic emissions

Trumpet has been thoroughly tested and respects the limits for electro-
medical devices specified by IEC 60601-1-2 standards. These limits ensure
reasonable protection against hazardous interference in typical medical
installations.
The instrument generates, uses and radiates radio frequency energy. If not
installed and used according to the instructions in this manual, it may
interfere with other nearby devices. No guarantee is given that interference
will not occur under certain conditions.
Trumpet should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, Trumpet should
be observed to verify normal operation in the configuration in
which it will be used.
The existence of electromagnetic interference can be verified easily by
switching the instrument off and back on again. If it is proven that the
device is indeed interfering with other devices, try to solve the problem by
adopting one of the following solutions:
- change the orientation and/or position of the affected device;
- move the two devices further away from each other;
- contact the manufacturer or authorised service organisation for
further assistance.

List of cables, transducers and accessories

Cables, transducers and accessories with which Inventis claims the
compliance with the IEC 60601-1-2 standard are the followings:
1) Power supply cable (maximum length: 1.8 m)
2) Power Supply, model no. MPU31-106-P01K002-B1F4-15V (L5)
3) REM Probe (manufactured by Inventis for Trumpet)
4) TDH39 or DD-45 transducers with 2 m double signal shielded cable (as
this one supplied with the device)
5) Bone vibrator B-71 transducer with twisted not shielded double signal
cable 2m (as this one supplied with the device)

55
6) Patient headset, manufacturer: Sennheiser, model: HD201 (as this one
supplied with the device)
7) Monitor headset with boom microphone, manufacturer: Sennheiser,
model: PC3 (as this one supplied with the device)
8) Talk back microphone with 1 m shielded cable (as this one supplied
with the device)
9) Patient response switch (manufactured by Inventis) with 2 m shielded
cable
10) Insert earphones, manufacturer: Etymotic, model: ER-3C (as this one
supplied with the device)
11) Loudspeaker cable, not shielded, maximum length: 5 m
12) USB cable, shielded, maximum length: 2 m

The use of accessories, transducers and cables other than those

specified, except for transducers and cables sold by the
manufacturer as spare parts for internal components, may result in
increased emissions or decreased immunity of the device.

Anyone connecting additional equipment is responsible for making sure the

system complies with the IEC 60601-1-2 standard.

Guidance and manufacturer’s declaration – electromagnetic emissions

Trumpet is intended for use in the electromagnetic environment specified below.
The customer or the user of Trumpet should assure that it is used in such an
environment.
Emissions test Compliance Electromagnetic environment-guidance
Trumpet uses RF energy only for its
internal function. Therefore, its RF
RF emissions
Group 1 emissions are very low and not likely to
CISPR11
cause any interference in nearby electronic
equipment.
RF emissions
Class B Trumpet is suitable for use in all
CISPR11
establishments including domestic
Harmonic emissions
Class A establishment and those directly connected
IEC 61000-3-2
to the public low-voltage power supply
Voltage fluctuations
network that supplies buildings used for
/ flickers emissions Complies
domestic purposes.
IEC 61000-3-3

56
 Guidance and manufacturer’s declaration – electromagnetic immunity
Trumpet is intended for use in the electromagnetic environment specified below.
The customer or the user of Trumpet should assure that it is used in such an
environment.
Electromagnetic
IEC 60601 Compliance
Immunity Test Environment -
test level Level
Guidance
Floors should be
wood, concrete or
Electrostatic ceramic tile. If floors
± 6kV contact ± 6kV contact are covered with
discharge (ESD)
± 8 kV air ± 8 kV air synthetic material,
IEC 61000-4-2 the relative humidity
should be at least
30%
± 2 kV for power ± 2 kV for power Mains power quality
Electrical fast should be that of a
supply lines supply lines
transient / burst typical commercial
± 1 kV for input / ± 1 kV for input / or hospital
IEC 61000-4-4 environment.
output lines output lines
± 1 kV differential ± 1 kV differential Mains power quality
mode mode should be that of a
Surge typical commercial
IEC 61000-4-5 ±2 kV common ±2 kV common or hospital
mode mode environment.
< 5% UT < 5% UT Mains power quality
should be that of a
(> 95% dip in UT) (> 95% dip in UT)
typical commercial
for 0,5 cycle. for 0,5 cycle. or hospital
Voltage dips, short 40% UT 40% UT environment. If the
user of Trumpet
interruptions and (60% dip in UT) (60% dip in UT) requires continued
voltage variations for 5 cycles. for 5 cycles. operation during
on power supply power mains
input lines 70% UT 70% UT
interruptions, it is
(30% dip in UT) (30% dip in UT) recommended that
IEC 61000-4-11 for 25 cycles. for 25 cycles. Trumpet be powered
from an
<5% UT <5% UT
uninterruptible
(> 95% dip in UT) (> 95% dip in UT) power supply or a
for 5 s. for 5 s. battery.
Power frequency
magnetic field
Power frequency should be at levels
(50/60 Hz) characteristic of a
magnetic field 3 A/m 3 A/m typical location in a
typical commercial
IEC 61000-4-8 or hospital
environment.
Note: UT is the a.c. main voltage prior to application of the test level.

57
 Guidance and manufacturer’s declaration – electromagnetic immunity
Trumpet is intended for use in the electromagnetic environment specified below.
The customer or the user of Trumpet should assure that it is used in such an
environment.
Immunity Test IEC 60601 Compl. Electromagnetic environment
Test Level Level – Guidance
Portable and mobile RF
communications equipment should
be used no closer to any part of
Trumpet, including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance
3 Vrms
Conducted RF
150 kHz to 3 Vrms d= 1,2 P
IEC 61000-4-6
80 Mhz

Radieted RF 3 V/m d= 1,2 P 80 MHz to 800MHz

80 Mhz to 3 V/m
IEC 61000-4-3
2,5 Ghz d= 2,3 P 800 MHz to 2,5 GHz

where P is the maximum output

power rating of the transmitter in
watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in
meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey,a should
be less than the compliance level in
each frequency range. b
Interference may occur in the
vicinity of equipment marked with
the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular / Cordless)
telephones and land mobile, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment
due to fixed RF transmitters, an electromagnetic site survey should be considered. If measured

58
field strength in the location in which Trumpet is used exceeds the applicable RF compliance
level above, Trumpet should be observed to verify normal operation. If abnormal performance
is observed, additional measures may be necessary, such as re-orienting or relocating Trumpet.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF

communications equipment and Trumpet
Trumpet is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of Trumpet can help prevent
electromagnetic interference by maintaining a minimum distance between portable
and mobile RF communications equipment (transmitters) and Trumpet as
recommended below, according to the maximum output power of the
communications equipment.
Separation distance according to frequency of transmitter
(m)
Rated maximum
output power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
transmitter (W)
d= 1,2 P d= 1,2 P d= 2,3 P
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
1 1,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) cam be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter in
watts (w) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

59
60