Interacoustics Lyra User manual

Instructions for Use - EN
Lyra
Science made smarter
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Table of contents
1Introduction ..................................................................................................................................1
About this manual ................................................................................................................1
Intended use ........................................................................................................................1
Contraindications .................................................................................................................1
Product description ..............................................................................................................1
Warnings ..............................................................................................................................3
2Unpacking and installation .........................................................................................................5
Unpacking and Inspection....................................................................................................5
Definition of symbols............................................................................................................6
Safety precautions ...............................................................................................................7
Connecting the Lyra to the PC/laptop ............................................................................... 10
2.4.1 Powering the Lyra ..............................................................................................................10
2.4.2 Data storage ......................................................................................................................10
Safety precautions to take when connecting the Lyra to PC/laptop. ................................ 10
IA OAE Suite software installation .................................................................................... 11
Installation of the driver..................................................................................................... 13
Standalone installation of IA OAE Suite software............................................................. 13
License.............................................................................................................................. 13
3Operating instructions.............................................................................................................. 15
Handling and selection of ear tips..................................................................................... 16
Probe test for TEOAE ....................................................................................................... 17
3.2.1 Performing the Probe Test.................................................................................................17
3.2.2 Functioning probe ..............................................................................................................17
3.2.3Faulty probe.......................................................................................................................18
4The IA OAE Suite....................................................................................................................... 19
PC power configuration..................................................................................................... 19
Compatible devices........................................................................................................... 19
4.2.1 Starting from OtoAccess™.................................................................................................19
4.2.2 Starting from Noah 4..........................................................................................................19
4.2.3 Simulation mode ................................................................................................................19
4.2.4 Crash report.......................................................................................................................20
Using the menu................................................................................................................. 21
Using the DPOAE module ................................................................................................ 22
4.4.1 Preparing for the test..........................................................................................................22
Using the TEOAE module................................................................................................. 29
4.5.1 Preparing for the Test ........................................................................................................29
Using the Print Wizard ...................................................................................................... 35
5Maintenance............................................................................................................................... 37
General maintenance procedures..................................................................................... 37
General maintenance procedures..................................................................................... 37
Cleaning the probe tip....................................................................................................... 38
Concerning repair.............................................................................................................. 39
Warranty............................................................................................................................ 39
6General technical specifications ............................................................................................. 41
Lyra Hardware – technical specifications ......................................................................... 41
Calibration properties........................................................................................................ 44
Electromagnetic compatibility (EMC) ................................................................................ 45

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1Introduction
About this manual
This manual is valid for the IA OAE Suite software version 1.0. The product is manufactured by:
Interacoustics A/S
Audiometer Allé 1
5500 Middelfart
Denmark
Tel.: [phone]
Fax: [phone]
E-mail: [e-mail]
Web: www.interacoustics.com
Intended use
The Lyra with DPOAE software is intended for use in the audiologic evaluation and documentation of ear
disorders using Distortion Product Otoacoustic Emissions. The target population for Lyra with DPOAE
includes all ages.
The Lyra with TEOAE software is intended for use in the audiologic evaluation and documentation of ear
disorders using Transient Evoked Otoacoustic Emissions. The target population for Lyra with TEOAE
includes all ages.
The Lyra system is to be used by trained personnel only, such as audiologists, ENT surgeons, doctors,
hearing healthcare professionals or personnel with a similar level of education. The device should not be
used without the necessary knowledge and training to understand its use and how results should be
interpreted.
Contraindications
Contraindications include the placement of the OAE probe in/on a patient’s ear in case of a discharging ear,
acute external auditory canal trauma, discomfort (e.g. severe otitis externa) or occlusion of the external
auditory canal. Testing should not be performed on patients with such symptoms without a medical doctor’s
approval.
For US only: Federal law restricts the sale, distribution, or use of this device to, by, or on the order of a
licensed medical practitioner.
Product description
The Lyra is a diagnostic device that interfaces with integrated audiologic software modules on a PC. Lyra
can perform (license controlled):
•Distortion Product Otoacoustic Emissions
•Transient Evoked Otoacoustic Emissions

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The system consists of the following included and options parts:
DPOAE
TEOAE
Included parts:
Lyra unit with permanent OAE probe1
BET25 Ear tips
Test cavity 0.2 and 0.5cc
IA OAE Suite software with DPOAE &
TEOAE
OtoAccess™ database software
USB cable
Carrying pouch
Included parts:
Lyra unit with permanent OAE probe1
BET25 Ear tips
Test cavity 0.2 and 0.5cc
IA OAE Suite software with DPOAE &
TEOAE
OtoAccess™ database software
USB cable
Carrying pouch
1Applied part according to IEC 60601-1

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Warnings
Throughout this manual the following meanings of warnings, cautions and notices apply:
The WARNING label identifies conditions or practices that may present
danger to the patient and/or user.
The CAUTION label identifies conditions or practices that could result in
damage to the equipment.
NOTICE NOTICE is used to address practices not related to personal injury.
WARNING
CAUTION

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2Unpacking and installation
Unpacking and Inspection
Check shipping box
As soon as the instrument is received, please check the shipping box for any sign of rough handling or
damage. If the box is damaged, keep the shipping material as it may be required for inspection by the carrier
regarding any potential insurance claim.
Keep carton
The Lyra comes in its own custom-made shipping carton. Please keep this carton as it will be needed if the
instrument has to be returned for service or repair.
Inspect instrument before connection
Prior to connecting the product, it should once more be inspected for potential damage. The cabinet and the
accessories should all be visually examined for scratches and missing parts.
Report immediately any concerns
Any missing part or any mechanical or electrical malfunction should be reported immediately to your local
distributor together with the invoice, serial number, and a detailed report of the problem.
Please refer to section ‘Return report’ in the back of this manual for information regarding Interacoustics returns
procedure.
Storage
If you need to store the Lyra for a period, please ensure it is stored under the appropriate conditions as
described in the Technical Specifications section, see chapter ‘Lyra Hardware – Technical Specifications’.

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Definition of symbols
The following symbols can be found on the instrument and/or accessories.
Symbol
Explanation
Type B applied parts
This is used for parts applied to the patient that require only ordinary
electrical protection, e.g. headphones.
Follow Instructions for Use
Caution
Refer to Instructions for Use
0123
The CE-mark indicates that Interacoustics A/S meets the requirements of
Annex II of the Medical Device Directive 93/42/EEC. TÜV Product Service,
Identification No. 0123, has approved the quality system.
Year of manufacture
Manufacturer
Serial number
Reference number
Do not re-use
Ear tips and similar are for single use only
Keep dry
Transport and storage temperature range
Transport and storage humidity limitations

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Transport and storage atmospheric pressure limitations
4005727
Conforms to
ANSI/AAMI ES60601-1:2005/A1:2
C er t i f i ed t o
CAN/CSA-C22.2 No. 60601-1:20
ETL CLASSIFIED
ETL listing mark
Company logo
LED light on On (Power: connection to the USB power)
LED light off Off (Power: disconnection from power)
Safety precautions
When connecting the instrument to the computer, the following warnings must be observed:
1. This equipment is intended to be connected to other equipment thus forming a Medical Electrical
System. External equipment intended for connection to signal input, signal output or other
connectors shall comply with the relevant product standard e.g. IEC 60950-1 for IT equipment and
the IEC 60601-series for medical electrical equipment. In addition, all such combinations – Medical
Electrical Systems – shall comply with the safety requirements stated the general standard IEC
60601-1, edition 3, clause 16. Any equipment not complying with the leakage current requirements in
IEC 60601-1 shall be kept outside the patient environment i.e. at least 1.5 m from the patient support
or shall be supplied via a separation transformer to reduce the leakage currents. Any person who
connects external equipment to signal input, signal output or other connectors has formed a Medical
Electrical System and is therefore responsible for the system to comply with the requirements. If in
doubt, contact qualified medical technician or your local representative. If the instrument is connect
to a PC (IT equipment forming a system) ensure not to touch the patient while operating the PC.
2. A Separation Device (isolation device) is needed to isolate the equipment located outside the patient
environment from the equipment located inside the patient environment. In particular such a
Separation Device is required when a network connection is made. The requirement for the
Separation Device is defined in IEC 60601-1 clause 16.
WARNING

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2.3.1 Cautions - general
If the system is not functioning properly, do not operate it until all necessary repairs are made and the unit is
tested and calibrated for proper functioning in accordance with Interacoustics’ specifications.
Do not drop or in any other way cause undue impact to this device. If the instrument is damaged, return it to
the manufacturer for repair and/or calibration. Do not use the instrument if any damage is suspected.
This product and its components will perform reliably only when operated and maintained in accordance with
the instructions contained in this manual, accompanying labels, and/or inserts. A defective product should
not be used. Make sure all connections to external accessories are secured properly. Parts which may be
broken or missing or are visibly worn, distorted, or contaminated should be replaced immediately with clean,
genuine replacement parts manufactured by or available from Interacoustics.
Equipment is not user repairable. Repairs must be performed by an authorized service representative only.
No modifications of the equipment are allowed by anyone other than a qualified Interacoustics
representative. Modification of the equipment could be hazardous.
Interacoustics will make available on request circuit diagrams, component part lists, descriptions, calibration
instructions, or other information that will assist authorized service personnel to repair those parts of this
instrument that are designated by Interacoustics as repairable by service personnel.
No parts of the equipment can be serviced or maintained while in use with the patient.
Connect only accessories purchased from Interacoustics to the instrument. Only accessories which have
been stated by Interacoustics to be compatible are allowed to be connected to the device.
2.3.2 Environmental factors
Storage outside temperature range as specified in section 5.1 may cause
permanent damage to the instrument and its accessories.
Do not use the device in the presence of fluid that can come into contact with any of the electronic
components or wiring. Should the user suspect fluids have contacted the system components or
accessories, the unit should not be used until deemed safe by an authorized service technician.
Do not place the instrument next to a heat source of any kind, and allow sufficient space around the
instrument to ensure proper ventilation.
CAUTION
CAUTION

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2.3.3 Electrical safety
Do not disassemble or modify the product as this may impact on the safety
and/or performance of the device. Refer servicing to qualified personnel.
For maximum electrical safety, turn off the power from a mains powered PC
when it is left unused.
Do not use the equipment if it is showing visible signs of damage.
2.3.4 Electromagnetic compatibility (EMC)
Although the instrument fulfills the relevant EMC requirements, precautions
should be taken to avoid unnecessary exposure to electromagnetic fields, e.g.,
from mobile phones, etc. If the device is used adjacent to other equipment it
must be observed that no mutual disturbance appears. Please also refer to the
appendix regarding EMC.
2.3.5 Explosion hazards
Do not use in the presence of flammable anesthetics or other gases.
Do NOT use in the presence of flammable gaseous mixtures. Users should
consider the possibility of explosions or fire when using this device in close
proximity to flammable anesthetic gases.
Do NOT use the instrument in a highly oxygen-enriched environment, such as
a hyperbaric chamber, oxygen tent, etc.
NOTICE
DO NOT connect the instrument to the computer before the software has been installed!
Great care should be exercised when handling OAE probe, as rough handling, for example dropping onto a
hard surface may break or damage the parts.
Within the European Union it is illegal to dispose of electrical and electronic waste as
unsorted municipal waste. Electrical and electronic waste may contain hazardous
substances and therefore have to be disposed of separately. Such products will be marked
with the crossed-out wheelie-bin image shown to the left. User cooperation is important in
order to ensure a high level of reuse and recycling of electrical and electronic waste. Failure
to recycle such waste products in an appropriate way may endanger the environment and
consequently the health of human beings.
Outside the European Union, local regulations should be followed when disposing of the product after its
useful life.
WARNING
CAUTION
WARNING

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Connecting the Lyra to the PC/laptop
NOTICE
DO NOT connect the Lyra hardware to the computer before the software has been installed!
First ensure the PC/laptop has the IA OAE Suite software installed, where the driver is also located. Please
refer to section 2.6 and 2.7.
Attach the USB cable to the Lyra device and to a free USB port on the PC/laptop.
The Lyra can be connected to a PC/laptop, where the software is installed.
2.4.1 Powering the Lyra
The Lyra is fully powered alone from the USB connection, no extra power or batteries are needed.
Ensure that the USB port can provide sufficient power to the Lyra, e.g. you may need to disable power save
schemes.
When the Lyra is powered, the LED light on the device will turn on, and off when not powered/connected.
NOTICE
The Lyra takes approximately 2 seconds to boot up.
2.4.2 Data storage
Any recordings and patients are stored only on the PC/Laptop, the Lyra does not store any recording or
patient data.
Safety precautions to take when connecting the Lyra to PC/laptop.
NOTICE
Please note that if connections are made to standard equipment like printers and networks, special
precautions must be taken in order to maintain medical safety.
Please follow the instructions below.
Fig. 1. Lyra connected to the PC/Laptop running on battery.
Fig. 2. Lyra connected to the PC/Laptop connected to a medical approved transformer.

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IA OAE Suite software installation
You must have administrative rights to the computer on which you are installing the IA OAE Suite software.
NOTICE
DO NOT connect the Lyra hardware to the computer before the software has been installed!
Important note on the use of Normative Data
The software have normative data available that can be displayed and compared to recordings made.
Further normative data can be created and the current ones can be edited.
Interacoustics claims no diagnostic consequence of degree of fit between the recorded results and whatever
normative data examples the operator chooses to bring forward for comparison.
Further information about the normative data can be obtained from the Lyra Additional Information Manual
and from Interacoustics.
PC minimum requirements
•Core i3 CPU or better (Intel recommended)
•8GB RAM or more
•Hard drive with min 10 GB free space (Solid State Drive (SSD) recommended)
•Minimum display resolution of 1280x1024 pixels or higher recommended)
•DirectX 11.x compatible graphics (Intel/NVidia recommended)
•One USB ports, version 1.1 or higher
Supported operating systems
•Microsoft Windows®7 32-bit and 64-bit
•Microsoft Windows®8 64-bit
•Microsoft Windows® 10 64-bit
Windows®is a registered trademark of Microsoft Corporation in the United States and other countries.
Important: make sure you have the latest service packs and critical updates installed for the version of
Windows®that you are running.
What you will need:
1. IA OAE Suite software Installation media
2. USB cable
3. Lyra hardware
To use the software in conjunction with a database (e.g. Noah 4 or OtoAccessTM), make sure the database is
installed prior to the IA OAE Suite software installation. Follow the manufacturer’s installation instructions
provided to install the relevant database.
Note that if you are using AuditBase System 5, you must ensure to launch this office system prior to this
installation of the IA OAE Suite software.

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Software installation on Windows®7, Windows®8 and Windows®10
Insert the installation media and follow the steps below to install the IA OAE Suite software. If the installation
procedure does not start automatically, click “Start”, then go to “My Computer” and double click the
“setup.exe” file to initiate the installation.
1. Wait for the installation dialog to appear, agree to the license terms and conditions, then click Install.
2. Follow the onscreen Lyra Installer instructions until the installation has been completed. Click on
“Close”. The software is now installed and ready to use.
During installation, Windows® may:
a) Ask if you want to allow changes to the computer. Click Yes if this happens
b) Ask to download and install a new Windows Feature (e.g., .NET Framework 3.5). Download and
install new features to ensure that the IA OAE Suite software works as intended
c) Warn you that Windows cannot verify the publisher of this driver software. Install the driver
software anyway to ensure the Lyra works as intended. If not installed, the Lyra will not be
detected by the computer when connected via USB
3. Upon launching the software for the first time, you will be asked to choose your regional settings
which activate a selection of factory protocols and the Instructions for Use (EN or US) of the IA OAE
Suite software.
Note that all regional factory protocols will be available through the show/hide protocols option for each
separate module. Refer to the Lyra Additional Information document for more details.
Note that the language can always be changed by selecting Menu | Setup | Language in the IA OAE Suite
software after installation.

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Installation of the driver
Now that the IA OAE Suite software is installed, you must install the driver for the Lyra.
1. Connect the Lyra via a USB connection (directly or via the cradle) to the PC.
2. The system will automatically detect the new hardware and a pop-up will appear on the task bar near
the clock indicating that the driver is installed and the hardware is ready to use.
To check that the driver has been installed properly, go to Device
Manager and verify Lyra appears under Medical devices.
Standalone installation of IA OAE Suite software
If you do not want to run the IA OAE Suite software through Noah 4 or OtoAccess™ you can make a
shortcut on the desktop to directly launch the IA OAE Suite software as a standalone module.
Go to Start | Programs | Interacoustics | IA OAE Suite software. Right click on IA OAE Suite software and
select Send To | Desktop (create shortcut). A shortcut for the IA OAE Suite software will now appear on your
desktop.
Note: Saving sessions in standalone mode will not link the measurements to a specific patient and cannot be
transferred to a patient in the database later.
License
When you receive the Lyra product, it already contains the license including the software modules you have
ordered. If you would like to add another module or function that is available in the IA OAE Suite software,
please contact your dealer for a license.

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3Operating instructions
The instrument is switched on by a powered USB connection. When operating the instrument, please
observe the following general precautions:
1. Use this device only as described in this manual.
2. Use only the disposable Sanibel ear tips designed for use with this instrument.
3. Always use a new ear tip for each patient to avoid cross-contamination. The ear tip is not designed
for reuse.
4. Never insert the OAE probe tip into the ear canal without affixing an ear tip as omission may damage
the patient’s ear canal.
5. Keep the box of ear tips outside the reach of the patient.
6. Be sure to insert the OAE probe tip in a way which will assure an airtight fit without causing any harm
to the patient. Use of a correct and clean ear tip is mandatory.
7. Be sure to use only stimulation intensities acceptable to the patient.
8. It is recommended to conduct an OAE probe test at the beginning of each day to ensure that the
probe and/or cable is functioning correctly for DPOAE/TEOAE measurements.
9. Clean the probe tip regularly to ensure wax or other debris stuck in the probe tip does not affect the
measurement.
10. The presence of tinnitus, hyperacusis or other sensitivity to loud sounds may contraindicate testing
when high intensity stimuli are used.
.
CAUTION

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NOTICE
1. Careful handling of the instrument whenever in contact with a patient should be given high priority.
Calm and stable positioning while testing is preferred for optimal accuracy.
2. The Lyra should be operated in a quiet environment, so that measurements are not influenced by
outside acoustic noises. This may be determined by an appropriately skilled person trained in
acoustics. ISO 8253 Section 11, defines a quiet room for audiometric hearing testing in its guideline.
3. It is recommended that the instrument be operated within an ambient temperature range as specified
in section 5.1.
4. Never clean the OAE probe housing with water or insert non-specified instruments into the OAE
probe.
Handling and selection of ear tips
When using the Lyra probe, SanibelTM OAE ear tips must be used.
The SanibelTM ear tips are single use only and should not be reused. Reuse of ear tips can lead to the
spread of infection from patient to patient.
The OAE probe must be fitted with an ear tip of a suitable type and size before testing. Your choice will
depend on the size and shape of the ear canal and ear. Your choice may also depend on personal
preference and the way you perform your test.
The umbrella shaped ear tips are not suitable for diagnostic OAE testings.
Use instead the mushroom shaped ear tips. Make sure that this ear tip inserts completely into
the ear canal.
Refer to the “Selecting the Correct Ear Tip” Quick Guide included in the Lyra Additional Information
document for an overview of ear tip sizes and selection.