EN

AUDIOMETER
TRIANGLE

USER MANUAL
 Read this manual thoroughly before using the device. Pay particular
attention to Chapter 1 (“Safety: warnings and information”) and
Chapter 2 (“Installation, power up and power down”).

Internal inspections and repairs must only be performed by

authorized personnel.

Copyright: INVENTIS S.r.l. 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 S.r.l..

Inventis ® is a registered trademark owned by INVENTIS S.r.l..

Document title: AU1S-User Manual EN

Revision: 07
Date: 03/08/2022
 Summary
Foreword ............................................................................................................ v
Chapter 1 Safety: warnings and information ...................................................1
1.1 Operator responsibilities ...................................................................1
1.2 Intended purpose ................................................................................2
1.3 Indication for use and end users of the device .................................2
1.4 Medical conditions ..............................................................................2 EN
1.5 Precautions ..........................................................................................2
1.6 Disposal ...............................................................................................5
1.7 Compliance .........................................................................................5
1.8 Symbols ...............................................................................................5
Chapter 2 Installation, power-up and power down ..........................................7
2.1 Package opening and contents inspection ........................................7
2.2 Precautions ..........................................................................................7
2.3 Connections .........................................................................................8
2.4 Keyboard Controls .............................................................................8
2.5 Power-up, power-down and main screen .........................................9
2.6 Connection to PC .............................................................................. 10
Chapter 3 Controls and exams ........................................................................ 11
3.1 Controls for direct access to exams ................................................. 11
3.2 Audiometry ....................................................................................... 11
3.3 Patient management ......................................................................... 15
3.4 Settings .............................................................................................. 16
Chapter 4 Maintenance ................................................................................... 19
4.1 Periodic checks ................................................................................. 19
4.2 Maintenance of transducers ............................................................ 20
4.3 Cleaning the instrument .................................................................. 21
4.4 Replacing the battery ....................................................................... 21
4.5 Repairs and technical assistance ..................................................... 22
Chapter 5 Troubleshooting .............................................................................. 23

iii
 Foreword

Thank you for purchasing an Inventis audiology device.

Advantageously compact and lightweight, the Triangle audiometer is a powerful
and versatile portable device, ideal for fast and accurate hearing level screening.
EN
The Inventis company has always considered the use of its devices in conjunction
with computers to be a factor of key importance. Installing the Maestro software
suite, available with or without proprietary database or as a Noah module, any
Inventis audiology device can be connected to a computer, and all examinations
conducted then archived in the user’s own database.
Bear in mind also that Inventis has developed a complete line of audiology
devices: in addition to audiometers, the company’s product line includes a range
of middle ear analyzers, REM and HIT hearing aid fitting devices, a wireless
video otoscope and much more.

For further information, and to report any problems of any kind, contact the
company at:

INVENTIS S.r.l.
Corso Stati Uniti, 1/3
35127 Padova, Italia
Tel.: 049.8962844 – Fax: 049.8966343
www.inventis.it [email protected]

v
 Chapter 1
Safety: warnings and information

Be sure to read this manual through completely, so that all of the features offered
by the 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. EN
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.

1.1 OPERATOR RESPONSIBILITIES

The Triangle audiometer is guaranteed to work efficiently and reliably only when
used according to the instructions and procedures outlined in this manual.
Should the device need to undergo repair or maintenance, it must be disconnected
from the electrical power supply and not used again until after the servicing has
been completed. Defective or faulty parts must only be replaced with original
spare parts supplied by Inventis, and all repairs must be carried out exclusively
by Inventis or by personnel it has authorized. No parts of the device must be
modified or replaced without authorization from Inventis.
The user 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 or its approved Service Centers. Inventis and approved
Service Centers will answer to the performance and reliability of the equipment
only if:
1. Adjustments, modifications or repairs are performed exclusively by
personnel authorized by Inventis.
2. The electrical system and earthing of the installation comply with the
standards for electro-medical devices.

1
1.2 INTENDED PURPOSE
The Triangle medical device is an audiometer. An audiometer is a device that
helps the operator define the patient’s auditory sensitivity by generating and
delivering to the patient sound stimuli of different types and intensities for
diagnostic purposes.

1.3 INDICATION FOR USE AND END USERS OF THE DEVICE

Triangle is intended for use by healthcare ENT professionals in hospitals, ENT
clinics and audiology offices in conducting hearing evaluations and assisting in
diagnosis of possible otologic disorders. There is no patient population restriction
in the use of the device. Always be sure to perform an otoscopy before using the
device.
These tests must be conducted in a quiet environment to avoid artifacts.

1.4 MEDICAL CONDITIONS

Conditions of impaired sensitivity of the auditory system or any conditions in
which the auditory system is thought to play a role in diagnosis.

1.5 PRECAUTIONS
Any serious incident that has occurred in relation to the device
should be reported to the manufacturer and the competent authority
of the Member State in which the user and/or patient is established.
To ensure correct and safe use of the device, the following precautions must be
observed.

1.5.1 General precautions

Make certain that the required environmental conditions are met
(during transport, storage and operation):
Temperature: 15°C (59°F) and 35°C (95°F)
Relative humidity: 30% to 90% (no
Operation
condensation)
Pressure: 700 hPa to 1060 hPa

2
 Temperature: between -10°C (14°F) and
50°C (122°F)
Transport and
Relative humidity: 0% to 90% (no
storage
condensation)
Pressure: 500 hPa to 1060 hPa
Warm-up time 1 minute

The device will not be protected if exposed during use to flammable

anesthetic gases or similar products. Risk of explosion.
Avoid installing and using the device near sources of strong
electromagnetic fields, which could interfere with the equipment’s EN
operation.
Use only original accessories supplied by INVENTIS S.r.l., unless
specifically indicated otherwise.

Use only the medical-grade power supply unit supplied with the
device, which complies with the IEC 60601-1 standard, with the
following specifications:
Rechargeable Li-Ion, 18650 standard,
3.7V 2.6Ah
Endurance: Minimum 12h continuous use
Auto-off time: 5 minutes
Internal battery
Stand-by time: 1 minute
Recharge time: from PC, standard USB
port: 10h max; from dedicated power
adapter: 3h max
External power Input 100-240Vac 50/60Hz, 0.3-0.15A
adapter Output 5Vdc 1.4A
Compliant with the IEC 60601-1 standard.
Triangle is a medical device: if connected to a computer (or any
external device) located within the “patient area” (as defined in
IEC 60601-1), this likewise must be a medical device, or protected
by an isolating transformer, in order to ensure that the combination
of computer (external device) + audiometer is in compliance with
IEC 60601-1.
Triangle must be installed and operated in accordance with the
information on electromagnetic compatibility (EMC) provided at
the end of this manual.
The proximity of portable and mobile appliances used for RF
communications can affect the operational efficiency of the
3
 instrument box. Refer to the information regarding electromagnetic
compatibility (EMC) provided at the end of this manual.

1.5.2 Calibration
The calibration should be performed at least once every 12 months,
and whenever a transducer is replaced.

The calibration of the instrument is valid only for the transducers

supplied. If a transducer is replaced, the instrument must be
recalibrated.

The calibration is valid for transducers supplied with the equipment,

if connected directly to the device without any interposition of
extension leads or other connectors. If a transducer is replaced or
not connected directly to the device, a new calibration is required
before using the device.

If the transducer selected is not calibrated, an alert will appear in

the test screens. It will not be possible to present any stimulus to the
patient using non-calibrated transducers.

Take note of the calibration interval indicated. Use of the device

after the calibration expiration can lead to unreliable diagnoses.

1.5.3 Hygiene
Disinfect the headphone pads between one patient and the next,
following the procedure described in Chapter 4: Maintenance.

Earpieces of the insert earphones are disposable. Do not use the

same earpiece for different patients. Dispose of them after use.

1.5.4 Use
The device can generate tones at an intensity potentially damaging
to the patient. Take particular care to set the intensity of the tone
correctly before it is presented.

When conducting audiometry using insert earphones, do not insert

or in any way try to conduct measurements without proper foam tip
in place.

4
 Maintaining the previous intensity of the stimulus when changing
frequency, transducer or stimulation side can result in potentially
harmful signals being presented to the patient.

Do not perform any service or maintenance while the device is being

used on a patient.

1.6 DISPOSAL
Like any other electronic device, your audiometer contains extremely small
quantities of certain hazardous substances. If such substances enter the normal EN
waste disposal cycle without suitable preliminary treatment, they can cause
damage to the environment and to health. Accordingly, at the end of its service
life, each component of the device must go through a sorted collection process.
This means that the user should deliver (or dispatch) waste items to the sorted
collection centers set up by local authorities, or alternatively return them to the
reseller when purchasing a new device of the same or similar type.
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 COMPLIANCE
The Triangle audiometer is a class IIa device, according to Annex VIII of
Medical Device Regulation (MDR) 2017/745/EU.
The Inventis Quality Management System has been certified by leading
assessment body TÜV as compliant with ISO 13485 standard.

1.8 SYMBOLS
Warning: the use of this device requires certain precautions.
To ensure safe use, consult the accompanying documentation.

Refer to instruction manual for use.

Medical device
Serial number of the device. The number is made up of 13
alphanumeric characters indicating the model, series, year of

5
 manufacture and serial number. In particular, the number
comprises these segments:
- Characters 1-5: Inventis product code
- Characters 6 and 7: year of manufacture (“20” means
2020)
- Characters 8-13: progressive serial number
Catalog code

Name and address of manufacturer

Type B applied parts (IEC 60601-1)

Product conforms to European Community Medical Device

Regulation (MDR) 2017/745/EU. Class IIa device; number of
notified body: 0123 (TÜV SÜD Product Service GmbH).
Caution: US Federal law restricts the sale of this device to or on
behalf of sale by or on the order of a licensed healthcare
practitioner
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.
Do not reuse.
Components bearing this mark can be used only once and must
not be reused thereafter.

UDI code

6
 Chapter 2
Installation, power-up and power
down

2.1 PACKAGE OPENING AND CONTENTS INSPECTION EN

Upon receiving the package, check that the box is not damaged and that the parts
contained are neither damaged nor defective.
Having made the various connections, carry out a further visual inspection before
switching on, to check for possible damage.
Should the device or any of its parts or detachable parts appear to be damaged or
defective, contact the dealer or Inventis service.

Keep the packaging materials in case you need to send the device to
the dealer or to Inventis for any reason.

2.2 PRECAUTIONS
Installation of the Triangle audiometer is easy but needs to be done carefully.
Incorrect installation could lead to safety issues while using the system.
Like any other electrical or electronic device, the audiometer will emit
electromagnetic waves. While the level of emissions is guaranteed to remain
within statutory limits, other electronic devices operating in the immediate
vicinity could be affected if particularly sensitive to electromagnetic
interference. If this should occur (interference is verifiable by turning the device
off and then turning it on again), it may be possible to solve the problem by
adopting one or more of the following solutions:
- Change the orientation and/or position of the affected device.
- Change the device’s distance from the audiometer.
- Plug the affected device into a power socket on a circuit that is different
from that of the audiometer.
- Consult the manufacturer or a service center for assistance.

7
2.3 CONNECTIONS
All connectors for detachable parts are located on the rear panel.

Plug all transducers and detachable parts into the respective sockets as indicated
in the following table:
Connector Attachment
Bone vibrator
AC headphones: Left
AC headphones: Right
Patient response switch
USB cable for power adapter or PC

Connect transducers and patient response switch only with the

device turned off.
Make certain that the electrical power supply and ground
connections comply with the applicable standards for electro-
medical devices. Risk of electric shock

2.4 KEYBOARD CONTROLS

Control Operation
When the device is OFF, press to
power ON. If the device is ON, press
to safely power it OFF, or hold down
for 10 seconds to turn off the device
without saving session data.
When pressed with other buttons,
enables the second functions

Send stimulus

Send masking

8
 Store the hearing level

Store a “no response”

Talk to the patient through the mic

(located above the Talk over button)

Change the stimulus level

EN

Change the masking level

Change the testing frequency

2.5 POWER-UP, POWER-DOWN AND MAIN SCREEN

Once all the cables are connected, Triangle can be turned on by pressing and
holding the power button for few seconds. The device can be turned off at any
time by pressing and holding the same button.
A few seconds after power-up, the display will show the following screen:

9
2.6 CONNECTION TO PC
The Triangle audiometer can be interfaced with a personal computer equipped
with the Inventis Maestro software. Connect the Triangle audiometer to a USB
port of the computer using the cable provided.
The Triangle can be connected either to a PC for recharging and transferring test
data, or to the power adapter supplied.

Use the supplied cable to connect the Triangle to one of the USB
ports of the computer

After a few seconds, the connected device will be recognized by the operating
system.
Refer to Maestro user manual for more details about the software.

10
 Chapter 3
Controls and exams

3.1 CONTROLS FOR DIRECT ACCESS TO EXAMS

Button Function EN
Access the manual Pure Tone Audiometry
(PTA)

Access the Automatic PTA

Access Patient Management

Save the current test to patient record

Delete the current exam

Access the Settings screen

3.1.1 Function buttons

Button Function

Go back to the main screen

Select the ear to be tested (Right selected in this example)

Delete the threshold saved for the selected ear

3.2 AUDIOMETRY
3.2.1 Common indicators
The following indicators are common to both manual and automatic tone
audiometry tests.
11
 Indication Information
Patient response button not pressed

Patient response button pressed

Headphones
right left

Headphones with active stimulus

Bone (only in Manual testing mode)

Insert earphones

3.2.2 Manual audiometry

Without “Bone conductor” license With “Bone conductor” license

The following controls and information are available only when the “Bone
conduction” license is enabled:

12
 Button Function

Select the transducer

Enable tracking (keep the same difference in dB between

stimulus and masking)

Indication Information

Masking level
EN
Masking enabled

Masking disabled

Swipe the screen to the left to view the stored thresholds. Swipe the screen to the
right to access the parameters:
- Stimulus type: Tone or Warble. Default: Warble.
- Stimulus mode: Continuous or Pulsed 1 Hz. Default: Continuous.
- Default intensity: Sets the default intensity of the stimulus. Default:
40 dB HL.
- Maintain intensity: Maintain the level after changing the frequency.
Default: disabled.
- Interrupter mode: Allows the interrupter key to be used as a button
(stimulation is active when the key is pressed) or switch (the first key
pressure activates the stimulus, the second one deactivates it). Default:
button.
- Automatic frequency jump: Enables/disables automatic frequency jump
after a value is stored. Default: disabled.
- Frequency selection: Access the frequency selection screen to
individually enable/disable the frequencies to be tested. Default value:
all frequencies enabled.

3.2.3 Automatic audiometry

Automatic audiometry is performed only with the AC transducer, without
masking.

13
 Button Function

Start the test

Pause the test

Stop the test

Swipe the screen to the left to view the stored thresholds. Swipe the screen to the
right to access the parameters:
- Frequency selection: Access the frequency selection screen to
individually enable/disable the frequencies to be tested. Default value:
all frequencies enabled.
- Test mode: Select the desired automatic algorithm:
o Hughson-Westlake auto-threshold, modified by Martin (the
threshold is taken in case of 2 correct answers out of 3)
o Quick search (a single correct answer stores the threshold)
o Fixed intensity (every frequency is tested once)
Default: Houghson-Westlake
- Minimum Level / Maximum Level: Set the range of test levels. Default:
-10 – 100 dB
- Familiarization: Enables/disables the additional phase used to train the
patient on the threshold determination procedure.

14
3.2.4 Results

Frequency not tested

No Response

EN

3.3 PATIENT MANAGEMENT

The Patient management screen allows adding (or modifying) patients and
reviewing stored exams. The first time the Patient Management screen is
accessed, Triangle asks for a PIN to prevent data access from unwanted accesses.
You can choose either to enter the PIN or disable data protection.

Message prompt at the first Patient Patient Management screen

Management screen access

Button Function
Go back to the main screen

Create a new patient

15
 Delete all the stored patients

Go back to the patient list

Side of thresholds stored

Delete current patient

3.4 SETTINGS
The Settings screen allows the user to modify the Triangle’s parameters.

Button Function

Go back to the main screen

Access the info screen, with serial number of the device,
calibrated transducers, firmware version and other
information for service

3.4.1 User-settable parameters

General configuration parameters for the device are listed below.
- Language: Interface language. Default value: English (may vary based
on destination)
- Date and time: Access the menu to adjust date and time and its format.
- Audiometry: Access the menu to select
16
 o AC output type: Select the AC transducer type, headphones
(AC) or insert earphones (AC-INS). Default: AC.
o PTA at start-up: Automatically start the device in Manual pure
tone screen. Default: disabled.
- Stand-by timeout: Sets the time before going to low-power mode.
Default: 1 minute.
- Data security: Access the menu to modify the PIN and enable/disable it.
- Display brightness: Set the display brightness between 20% and 100%.
Default: 80%.
EN
- Licenses: Access the menu to enable additional licenses.

17
 Chapter 4
Maintenance

The Triangle audiometer does not require any special periodic maintenance other
than calibration and normal cleaning, both of which are described in this chapter.
The device must be turned off before starting any kind of cleaning operation.
EN
The performance and safety of the device will be assured as long as the
recommendations for care and maintenance indicated here are correctly
followed.

Apart from replacing the battery, the inspection and servicing of

internal components must be left 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.

4.1 PERIODIC CHECKS

The procedure described under this heading must be carried out
when the device is used for the first time each day.

The tests must be conducted with the device positioned for normal
use.
- Before switching on the device, be sure that there is no sign of damage
visible on the equipment, including the detachable parts and the external
power adapter. Visually inspect the power cable and connectors to
verify the insulation’s integrity, and make sure that they are not subject
to any kind of mechanical loading or stress that could cause damage.
Make sure that all parts and cables are properly connected.
- Check subjectively that the air conduction and bone conduction output
is equal on both channels and all frequencies, e.g. by generating a
stimulus @ 10 or 15 dB, just enough to hear. The person who carries
out this check should have good hearing.

19
 - Check at a level of 60 dB in AC and 30 dB in BC that there is no
distortion, noise or parasitic signals in any of the frequencies.
- Check that the interrupter key, the patient response switch and the
keyboard indicators function correctly.
- Check that the attenuator knobs function correctly without noise or
interference between channels.
- Check the headband strain of headset and of the bone vibrator.
- Check the communication with the patient.

If any part or transducer has any malfunction, consult Appendix A

“Troubleshooting”.

Check whether that the calibration interval has not expired: the date is shown on
the info screen accessible from the setup menu.
Calibration must be entrusted to technicians approved by INVENTIS
S.r.l.. The operation should be performed at least once every 12
months and whenever a transducer is replaced.

4.2 MAINTENANCE OF TRANSDUCERS

Do not use liquids or sprays to clean the audiometer.

Do not allow dust to collect on the transducers. Also:

- the cushions of the headphones are made of biocompatible material but
are not sterile. To prevent the spread of infections and to ensure their
biocompatibility, they must be sanitized before being used on a new
patient using wipes or a microfiber cloth dampened with denatured
alcohol.
- The earpieces of the insert earphones are intended to be inserted in the
patient’s ear canal. They are made of biocompatible material and must
be used only once, then discarded in compliance with current waste
disposal regulations.

The eartips of insert earphones are not sterile. The use of

unsterilized earpieces can cause ear infections.

20
 The headphone cushions can be repeatedly cleaned as described in
the “Maintenance of Transducers” paragraph. In the event of any
malfunctioning after any cleaning operation, contact an Inventis
service technician.
Though the headphone cushions can be repeatedly cleaned, always
check that their characteristics and integrity are maintained. To do
so, it is sufficient to perform the tests described in the “Periodic
checks” paragraph. As soon as any failure is encountered, contact
an Inventis service technician to verify whether your transducer
needs to be replaced.
To avoid damaging the headphones, do not crush them against a flat EN
surface: this can create a vacuum and cause damage to the
transducer (suction cup effect).

4.3 CLEANING THE INSTRUMENT

Clean the device using a lint-free soft cloth moistened with water and mild
detergent. If it needs to be sanitized, moisten the cloth with a 3% solution of
hydrogen peroxide.

4.4 REPLACING THE BATTERY

If the device fails to operate as long as expected despite a full charge, the battery
may be damaged or dead.
Purchase a new battery from an Inventis-approved dealer, then replace the
existing battery as described below:
- Turn off the device and disconnect it from the USB cable.
- Position it face down (display directed downwards) on a soft surface.
- Undo the screw retaining the flap of the battery compartment.
- Remove the battery. Separate the connectors without tugging. Ease
apart using tweezers.
- Connect the new battery.
- Position the lead inside the compartment below the screw and position
the new battery in its housing, then close the flap and secure with the
retaining screw.
Recharge the device completely before use.
All detachable parts mentioned in the manual are designed
specifically for use with this device. Only detachable parts supplied
by Inventis should be connected to the audiometer.

21
4.5 REPAIRS AND TECHNICAL ASSISTANCE
Before contacting the service department, make certain that all the possible
solutions in appendix Troubleshooting have been tried.
Parts that are to be returned to the manufacturer must be cleaned and sanitized,
following the directions in this manual. Transducers must be shipped in a closed,
sealed transparent bag.
Should the instrument need to be sent to the service department or returned to
the dealer, it is important that the original packing be used, enclosing all
detachable parts and transducers.

22
 Chapter 5
Troubleshooting

Problem Possible cause Solution

Transducer not Make sure that the transducer is EN

connected properly connected properly
No signal from a
transducer
Transducer Contact the Inventis service
damaged department or dealer

Problems with USB Check the USB connection between

Unable to establish a connection the device and the computer
direct connection
between the PC and
the Triangle USB cable Change the USB cable (USB A –B
damaged standard)

The instrument does

Low battery Connect the device to a power source
not switch on

Touch the screen or press the power

Device in stand-by
button
The display remains
blank (LED on)
Contact the Inventis service
Display damaged
department or dealer

USB cable Change the USB cable (USB A –B

damaged standard)

Battery does not Contact the Inventis service

Adapter damaged
recharge department or dealer

Replace the battery - Contact the

Battery damaged
Inventis service department or dealer

23
 Problem Possible cause Solution

Press OK to continue. If the problem

message: Non-fatal internal
persists, contact the Inventis service
“Hardware error” error
department

Restart the device. If the problem

message:
Fatal internal error persists, contact the Inventis service
“Serious error”
department

24
 FR

AUDIOMETRE
TRIANGLE

MANUEL UTILISATEUR