Inventis TRIANGLE User manual

EN
IT
DE
FR
ES
PT
NL
PL
AUDIOMETER
TRIANGLE
MULTILANGUAGE USER
MANUAL
Document title: AU1S-User Manual
Revision: 02
Date: 03/07/2020

EN
AUDIOMETER
TRIANGLE
USER MANUAL

Read this manual carefully before using the device. Pay particular
attention to the instructions given in Chapter 1 and in Chapter 2.
Internal inspections and repairs must only be performed by
authorized personnel.
Copyright: Inventis srl. 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 srl.
Inventis ® is a registered trademark owned by Inventis srl.
Document title: AU1S-User Manual EN
Revision: 04
Date: 03/07/2020

iii
EN
Summary
Foreword............................................................................................................v
Chapter 1 Introduction......................................................................................1
1.1 Operator responsibilities ...................................................................1
1.2 Intended use........................................................................................1
1.3 Indication for use and end users of the device .................................2
1.4 Main features......................................................................................2
1.5 Warnings and Precautions.................................................................2
1.6 Disposal ...............................................................................................4
1.7 Conformity..........................................................................................4
1.8 Symbols ...............................................................................................4
Chapter 2 Installation and use..........................................................................7
2.1 Package opening and contents inspection ........................................7
2.2 Parts, accessories and licenses...........................................................7
2.3 Precautions..........................................................................................8
2.4 Connections.........................................................................................8
2.5 Keyboard Controls.............................................................................9
2.6 Power-up and main screen ..............................................................10
Chapter 3 Audiometry......................................................................................11
3.1 Touchscreen controls .......................................................................11
3.2 Common indicators..........................................................................11
3.3 Manual audiometry..........................................................................12
3.4 Automatic audiometry .....................................................................14
Chapter 4 Patient management.......................................................................17
4.1 Touchscreen controls .......................................................................17
4.2 Create new patient............................................................................18
4.3 View patient data..............................................................................18
4.4 Store tests ..........................................................................................18
Chapter 5 Settings............................................................................................19
5.1 User-settable parameters.................................................................19
Chapter 6 Interface with PC............................................................................21

iv
6.1 Connection to PC .............................................................................21
Chapter 7 Maintenance...................................................................................23
7.1 Periodic checks.................................................................................23
7.2 Transducers maintenance ...............................................................24
7.3 Cleaning the device ..........................................................................24
7.4 Replacing the battery.......................................................................25
7.5 Repairs and technical assistance.....................................................25
Appendix A Technical Specifications.............................................................27
Appendix B Troubleshooting ..........................................................................33
Appendix C Electromagnetic compatibility ....................................................35

v
EN
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.
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 srl
Corso Stati Uniti, 1/3
35127 Padua Italy
Tel.: [phone] –Fax: [phone]
www.inventis.it [e-mail]

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EN
Chapter 1
Introduction
Be sure to read this manual through completely, so that all the features offered
by the device can be used to their full potential.
In this manual, the safety symbol shown below draws the reader’s attention to
information that is particularly important for safe and correct 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.
1.2 INTENDED USE
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

2
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 and to
ensure that errors are not committed when determining the hearing threshold.
1.4 MAIN FEATURES
The Triangle is a portable device that can be used to conduct audiometric
screening tests simply, swiftly and accurately. The device is able to meet the
needs of private medical practices, clinics and hospitals alike.
The main strengths of the device are:
-Backlit color display with touchscreen interface.
-Compact and ergonomic design, lightweight construction.
-Long durability with built-in rechargeable lithium battery.
1.5 WARNINGS AND PRECAUTIONS
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 ambient conditions are met (during
transport, storage and operation) as indicated in Appendix A.
The device will not be protected if exposed during use to flammable
anesthetic gases or similar products. Risk of explosion.
Use only original accessories supplied by Inventis srl, unless
specifically indicated otherwise.
Triangle can be used in conjunction with a soundproof booth to
conduct tests under optimum acoustic conditions. Before connecting

3
EN
the device to a soundproof booth, check that the sockets are
compatible with the specifications prescribed for each connector.
Use only the medical grade power adapter supplied with the device,
IEC 60601-1 certified. For further information see Appendix A.
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 taking into account the
information regarding electromagnetic compatibility (EMC)
provided in Appendix C.
Avoid installing and using the device near sources of strong
electromagnetic fields, which could interfere with the equipment’s
operation.
The proximity of portable and mobile appliances used for RF
communications can affect the operational efficiency of the
instrument box. Refer to the information regarding electromagnetic
compatibility (EMC) provided in Appendix C.
1.5.2 Calibration
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 (e.g. when connected to a
soundproof booth). 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.

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1.5.3 Hygiene
Disinfect the headphone cushions between one patient and the next,
following the procedure described in Chapter 7.
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.
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
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 CONFORMITY
The Triangle audiometer is a class IIa device, in accordance with Annex IX of
the medical devices directive 93/42/EEC as amended and supplemented by
directive 2007/47/EC. Inventis srl is a company ISO 13485 certified.
1.8 SYMBOLS
Warning: the use of this device requires certain precautions. To
ensure safe use, consult the accompanying documentation.

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EN
Refer to the instructions for use.
Follow instructions for use.
Device serial number:
-Characters 1-5: Inventis product code
-Characters 6-7: year of manufacture ("20" denotes 2020)
-Characters 8-13: progressive serial number
Catalog code
Name and address of manufacturer
Type B applied parts (IEC 60601-1)
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).
Rx only
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

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EN
Chapter 2
Installation and use
2.1 PACKAGE OPENING AND CONTENTS INSPECTION
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 accessories 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 PARTS,ACCESSORIES AND LICENSES
Parts and accessories supplied with the product are:
-Audiometer (lithium-ion battery included)
-RadioEar DD45 supra-aural headphones1or RadioEar DD65 circum-
aural headphones
1
-Patient response button1
-USB cable
-Medical grade USB multi socket power adapter
-Carrying case
-Audiometer user manual
-Audiogram cards
-Conformity and calibration certificates
Optional accessories are:
-Etymotic Research Inc. ER-3C
2
insert earphones
-RadioEar B-71 bone conductor2
1
Applied part according to IEC 60601-1
2
Applied part according to IEC 60601-1

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Additional licenses available are:
-“Computer connectivity” for the connection of the Triangle with the
computer.
-“Bone conduction” to enable the bone conduction stimulation and
noises on the AC contralateral headphone.
2.3 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 the position of the device affected by
interference.
-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.
2.4 CONNECTIONS
All connectors for accessories are located on the rear panel.
Plug all transducers and accessories into the respective sockets as indicated in
the following table:
Connector
Attachment
BONE
Bone vibrator
ACL
AC headphones: Left
ACR
AC headphones: Right
P.RESP
Patient response switch

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EN
USB cable for power adapter or PC
Connect transducers and patient response switch only with the
device turned off.
The Triangle can be connected either to a PC for recharging and transferring test
data, or to the power adapter supplied. Use only the USB cable supplied with the
product.
2.5 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
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
Change the masking level

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Change the testing frequency
2.6 POWER-UP 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:
Icon
Operation
Access the manual Pure Tone Audiometry
(PTA)
Access the Automatic PTA
Access the Patient Management (see Chapter 4)
Store the current exam in the patient memory
(see Chapter 4)
Delete the current exam
Access the Settings screen (see Chapter 5)

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EN
Chapter 3
Audiometry
The audiometry test can be conducted either in manual mode or in automatic
mode. Before proceeding with the test, have the patient wear the chosen
transducers and check the info screen accessible from the settings screen to make
sure that the transducers are the ones calibrated
3.1 TOUCHSCREEN CONTROLS
The following touchscreen controls are common for both Automatic and Manual
pure tone audiometry.
Icon
Operation
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 COMMON INDICATORS
The following indicators are common for both Automatic and Manual pure tone
audiometry.
Icon
Information
Patient response button not pressed
Patient response button pressed
right left
Headphones

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Headphones with active stimulus
Bone (only in Manual testing mode)
Insert earphones
3.3 MANUAL AUDIOMETRY
Use keyboard controls (see paragraph 2.5) and touch controls (see paragraph 3.1)
to modify the exam parameters and send stimulus to the patient.
Without “Bone conductor” license
With “Bone conductor” license
If either a threshold or a No Response has already been stored with the current
settings for transducer, side and frequency, the frequency label will be
highlighted with the color of the current side. Swipe the screen to the left to view
the stored thresholds.