Interacoustics Lyra Instructions For Use Manual

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Instructions for Use - EN

Lyra

Science made smarter

D-0119867-C – 2019/03

Table of contents

Introduction ..................................................................................................................................1

About this manual ................................................................................................................1

Intended use ........................................................................................................................1

Contraindications .................................................................................................................1

Product description ..............................................................................................................1

Warnings ..............................................................................................................................3

Unpacking 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

Operating 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

3.2.3 Faulty probe ....................................................................................................................... 18

The 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

Maintenance ............................................................................................................................... 37

General maintenance procedures..................................................................................... 37

Cleaning the probe tip ....................................................................................................... 38

Concerning repair.............................................................................................................. 39

Warranty ............................................................................................................................ 39

General technical specifications ............................................................................................. 41

Lyra Hardware – technical specifications ......................................................................... 41

Calibration properties ........................................................................................................ 44

Electromagnetic compatibility (EMC) ................................................................................ 45

1 Introduction

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.: +45 6371 3555 Fax: +45 6371 3522 E-mail: info@interacoustics.com 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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DPOAE

TEOAE

Included parts:

The system consists of the following included and options 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

Applied part according to IEC 60601-1

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WARNING

CAUTION

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.

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2 Unpacking 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

Symbol

Explanation

Type B applied parts Follow Instructions for Use

The CE-mark indicates that Interacoustics A/S meets the requirements of

Year of manufacture Manufacturer

Serial number

Reference number

Keep dry Transport and storage temperature range

Transport and storage humidity limitations

The following symbols can be found on the instrument and/or accessories.

This is used for parts applied to the patient that require only ordinary electrical protection, e.g. headphones.

Caution

Refer to Instructions for Use

Annex II of the Medical Device Directive 93/42/EEC. TÜV Product Service, Identification No. 0123, has approved the quality system.

0123

Do not re-use Ear tips and similar are for single use only

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Transport and storage atmospheric pressure limitations

4005727

Conforms to

ANSI/AAMI ES60601-1:2005/A1:2

C ert i f i ed t o

CAN/CSA-C22.2 No. 60601-1:20

ETL CLASSI FIED

ETL listing mark

Company logo

WARNING

LED light on

LED light off

On (Power: connection to the USB power)

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.

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CAUTION

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.

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Do not disassemble or modify the product as this may impact on the safety

For maximum electrical safety, turn off the power from a mains powered PC when it is left unused.

Although the instrument fulfills the relevant EMC requirements, precautions

a hyperbaric chamber, oxygen tent, etc.

WARNING

CAUTION

WARNING

2.3.3 Electrical safety

and/or performance of the device. Refer servicing to qualified personnel.

Do not use the equipment if it is showing visible signs of damage.

2.3.4 Electromagnetic compatibility (EMC)

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. appendix regarding EMC.

Please also refer to the

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

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.

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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.

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.

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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

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

7 32-bit and 64-bit

8 64-bit

10 64-bit

To use the software in conjunction with a database (e.g. Noah 4 or OtoAccess

), 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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CAUTION

3 Operating 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.

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Use instead the mushroom shaped ear tips. Make sure that this ear tip inserts completely into

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, Sanibel

OAE ear tips must be used.

The Sanibel

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.

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.

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Figure 1 - Probe test has passed/functioning probe

Probe test for TEOAE

Probe performance is crucial to TEOAE test results. We recommend that you conduct a probe test at the beginning of each day before starting to test on patients to ensure that the probe is functioning correctly.

• Before conducting the probe test, ensure that the probe tip is clean and free of wax and/or debris

• Always conduct the probe test in a quiet test environment

• Only use the recommended cavity for testing. Using a different type of cavity may either not detect

probe faults or may incorrectly indicate a faulty probe

3.2.1 Performing the Probe Test

1. Select the TEOAE 1-4kHz.protocol.

2. Insert the probe tip without an ear tip attached into the 2cc cavity provided with the Lyra.

3. Press the Start button and let the test run until it stops after 2 minutes. Do not stop the test manually.

4. If the probe is functioning correctly (no TE bands get a checkmark), it is possible to continue with daily testing.

5. If error messages appear during testing or if one or more of the TE bands has a checkmark above it at the end of the test, the probe test has failed. Check and clean the probe tip for wax or debris and redo the probe test. If the probe test fails a second time, the Lyra must

not be used to test on patients. Contact your local distributor for assistance.

3.2.2 Functioning probe

If the probe is functioning correctly, none of the TE bands will have a checkmark above them when the test ends similar to Figure 1 below.

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Figure 2 - Probe test has failed/faulty probe

3.2.3 Faulty probe

If error messages appear during testing or if one or more of the TE bands has a checkmark above it at the end of the test, the probe test has failed.

The most common cause of a probe test failure is wax or debris in the probe tip. Check and clean the probe tip for wax or debris and redo the probe test. If the probe functions correctly after removing wax or debris, continued use of the probe to test patients is ok.

If the probe status indicates “Too noisy”, this indicates that the environment is too noisy for testing or there is a probe fault. Stop the test, clean the probe and/or move to a quieter area and perform the test again.

If the probe test still indicates a faulty probe after a second test, the Lyra must not be used to test on patients. Contact your local distributor for assistance.

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4 The IA OAE Suite

PC power configuration

NOTICE

Allowing the PC to go into sleep mode or hibernation may cause the IA OAE Suite software to crash when the PC wakes up again. From the Start menu of your operating system, go to the Control Panel | Power

Options to change these settings.

Compatible devices

The IA OAE Suite software is compatible with Interacoustics Lyra, Eclipse and Titan. This software can show recordings from all the devices, but protocol and patient upload/download to the handheld device Titan is only operated from the Titan Suite. However once saved to the database, the IA OAE Suite software can be used to open and display the recordings.

4.2.1 Starting from OtoAccess™

For instructions about working with the OtoAccess™ database, please see the instruction for use for OtoAccess™.

4.2.2 Starting from Noah 4

Ensure that the Lyra is connected before opening the software module. If the hardware is not detected, the IA OAE Suite software is opened in reader mode.

To start the IA OAE Suite software from Noah 4:

1. Open Noah 4.

2. Search for and select the patient you want to work with.

3. If the patient is not yet listed:

- Click on the Add a New Patient icon

- Fill in the required fields and click OK

4. Click on the IA OAE Suite software module icon at the top of the screen.

For further instructions about working with the database, please see the operation manual for Noah 4.

4.2.3 Simulation mode

You can enable simulation mode from Menu-Setup-Simulation mode. In simulation mode you can simulate protocols and views before the actual testing on subject. Print report previews can also be tested if needed. When the software is launched, simulation mode is always disabled by default to ensure no “artificial recordings” are made by accident. “Recordings” made in the simulation mode cannot be saved as the data are random and not patient related.

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4.2.4 Crash report

In the event that the IA OAE Suite software crashes and the details can be logged by the system, the Crash Report window will appear on the test screen (as shown below). The crash report provides information to Interacoustics about the error message and extra information can be added by the user outlining what they were doing before the crash occurred to assist in fixing the problem. A screen shot of the software can also be sent.

The “I agree to the Exclusion of Liability” check box must be checked before the crash report can be sent via the internet. For those users without an internet connection, the crash report can be saved to an external drive so it can be sent from another computer with an internet connection.

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Menu provides access to Setup, Print, Edit and Help.

Using the menu

The following section describes the elements of the Menu which is accessible from both DPOAE and TEOAE module tab:

• Menu | Setup | Protocol setup create custom test protocols, or change the default protocols

• Menu | Setup | Temporary setup change protocols temporarily

• Menu | Setup | Show/Hide protocols hide or show protocols as preferred

• Menu | Setup | General setup Set specific OAE test parameters and automated print to pdf

• Menu | Setup | Norm data setup customize and import/export OAE norm data

• Menu | Setup | Password protection set a password for the setup

• Menu | Setup | Language allows selection of one of the available .languages. The language

selection change will come into effect after the IA OAE Suite software is reopened

• Menu | Setup | Simulation mode activate the simulation mode, and trial out the protocols or see how data is visualized

• Menu | Print preview print, print wizard and print

• Menu | Edit export the data to an XML file

• Menu | Help | About OAE software… displays an information window showing the

following:

o IA OAE Suite software version o Hardware version o Firmware version o Copyright Interacoustics

Further, you can reach the Interacoustics website from this window by clicking on the link to

www.interacoustics.com

By pressing the License button you are able to change the license keys of the device. The license keys for the device are specific for each serial number and define which modules, tests, protocol settings and other functionalities are available. Never change the license key without help of an authorized technician

• Menu | Help | Documents… launches digital version of the Instructions for Use Manual and Additional information manual (Adobe Reader required)

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Using the DPOAE module

4.4.1 Preparing for the test

Patient instruction

Place the patient on a bed or comfortable chair or on an examination table if necessary. Small children may feel more comfortable sitting on a parent's or nurse's lap. Show the probe to the patient and then explain the following:

• The aim of the test is to screen the hearing organ for its functionality

• The tip of the probe will be inserted into the ear canal and has to make a good seal

• Multiple tones will be heard during the test

• No participation is expected from the patient

• Coughing, moving, talking and swallowing will disturb OAE test results

Visual inspection of the ear canal

Check the external ear canal for wax with an otoscope and remove excessive wax to prevent the probe opening from clogging which will inhibit testing. Excessive hairs may have to be cut. If contraindications exist, the patient should be inspected by ENT or medical specialist.

Probe performance is crucial to OAE test results. We recommend that you conduct a probe test at the beginning of each day before starting to test on patients to ensure that the probe is functioning correctly.

Prepare the equipment

1. Turn on Lyra by connection the USB to the PC.

2. Open the OtoAccess

3. Double click on the IA OAE Suite software. Icon to launch the software and click on the OAE module tab DP.

4. Select the desired test protocol from the dropdown list.

5. Select the ear for testing.

Before conducting the OAE test, ensure that the probe tip is clean and free of wax and/or debris.

Test environment

Always conduct the OAE test in a quiet test environment, high ambient background noise will affect the OAE recording.

6. Select an ear tip size that will ensure a good seal in the ear canal.

7. Check the probe check status in the software to verify a good seal.

or Noah database and enter new patient details.

When the probe is detected to be Out of ear the color is red, In ear the color is green.

When Blocked or Too Noisy the colored bar is amber.

8. Results for DP-Gram testing, OAE present right side and no OAE response left side.

The type of test (DP-Gram or DP-IO) and ear side symbol and color is written on the top of the graph. The green checkmarks indicates the DP points there have met the DP criteria as set in the protocol, as

show above for the right ear. The DP points having no checkmark did not meet the DP criterion and can be either below the noise or absent. The DP points are line connected with the ear side color, to give an overall impression of the DPOAE levels. The grey area is the background noise in the DP test.

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Menu provides access to Setup, Print, Edit or Help (refer to Guidance button opens the user guide which shows

Print allows for printing the onscreen results directly to your Print to PDF icon appears when setup via the General Save & New Session saves the current session in Noah 4

Save & Exit saves the current session in Noah 4 or Toggle Ear changes from right to left ear and vice versa in

4.4.2 Elements in the DPOAE module

The following section describes the elements of the DPOAE screen.

the Additional Information document for more details about the menu items).

instructions for testing within the module. The guidance can be personalized in the User guide setup window.

default printer. You will be prompted to select a print template if the protocol does not have one linked to it (refer to the Additional Information document for more details about the print wizard).

Setup. This allows for printing directly to a PDF document that is saved to the PC. (Refer to the Additional Information document for setup information).

or OtoAccess™ (or to a commonly used XML file when running in standalone mode) and opens a new session.

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OtoAccess™ (or to a commonly used XML file when running in standalone mode) and exits the OAE software.

all modules.

List of Defined Protocols allows for selecting a test

Temporary setup allows for making temporary changes to

List of historical sessions accesses historical sessions for

session date to overlay historic sessions on the graph.

Go to current session takes you back to the current

Probe status is shown by a colored bar with description next

Summary view toggles between displaying result graph or

Monaural/Binaural view toggles between showing the

Report editor button opens a separate window for adding

Checking the Acceptable noise level Off box disables the

The Acceptable noise level slider allows setting the

amber in color when exceeding the set level.

The hardware indication picture indicates whether the Lyra

in simulation mode (user chosen).

protocol for the current test session (refer to the Additional Information document for more details about protocols).

the selected protocol. The changes will be valid for the current session only. After making the changes and returning to the main screen, the name of the protocol will be followed by an asterisk (*).

review or the Current Session.

The historical session box can be expanded by dragging downwards with the mouse or minimized/maximized by clicking on the arrow button.

The session highlighted in orange, is the selected session displayed on screen. Check the checkbox next to the

session.

to it.

When the probe status is Out of ear it will show the color of the selected ear (blue for left and red for right). When the probe is detected to be In ear the color is green. When Blocked, Leaking or Too Noisy the colored bar is amber. When No probe is detected the status bar is grey.

result graph with test summary tables.

results of a single ear or both ears.

and saving notes to the current or historic session.

rejection of any recording even when there is too much noise in the recording.

acceptable noise level limit between -30 and +30 dB SPL above which recordings are considered to be too noisy. The VU meter indicates the current noise level and becomes

or Eclipse hardware is connected. Simulation mode is indicated when operating the software

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Before testing, the Timer symbol indicates after how much

The protocol listing shows all tests that are part of the A checkmark in the box indicates that the test will run when

A white checkmark indicates that (at least some) data for

Pause becomes active after testing has started. It allows for

START (and STOP) button are used for starting and

The probe check graph provides a visual display of the probe

time the DPOAE test will automatically stop. During testing the timer counts down to zero. You can disable the countdown by clicking on the timer during testing. As a result the timer will begin counting up and indicate how much test time has passed. Then the test will continue until you manually press stop.

When the measurement is rejecting, the timer will stop counting. Artifact rejection is dependent upon the Acceptable Noise Level setting and Level tolerance level set in the protocol.

selected protocol. The test that is displayed in the test screen area is highlighted blue or red, depending on the chosen ear.

START is pressed. During testing the tests which have been completed will automatically become unchecked. Uncheck the boxes of tests you do not wish to run under the selected protocol before pressing ST ART.

this test is stored in the memory.

pausing during a test.

stopping the session.

fit in the patient’s ear before and after testing.

During testing, the probe check is not running and the graph will not display a curve.

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The response graph shows the response recorded by the

Hovering the mouse over a measurement point shows

The DP found checkmark symbol, a black checkmark in a

The DP found checkmark symbol, a black checkmark,

The time out symbol, a clock, indicates that the

The noise floor symbol, an arrow pointing at a line,

probe microphone (in dB SPL) as a function of the frequency (in Hz). Only the frequency range that is relevant for the currently measured or currently selected point is plotted.

1. The two test stimuli are easily recognized as the two peaks in the response graph.

2. The stimulus tolerance range is indicated by two shaded areas above and below the peak of the stimulus.

3. The red or blue line indicates the DPOAE frequency at which the main distortion product is expected.

See the Additional Information document for further details.

details about the ongoing or finished measurement.

See the Additional Information document for more specific details of each item in the mouse over table.

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green circle, indicates that this individual measurement met its specified criterion and no further testing at this frequency will occur.

indicates that this individual measurement met its specified criterion, but testing will continue until the test time runs out or the test is manually stopped.

measurement has ended without reaching the specified criterion for the individual point within the time allowed. In the general setup it can be chosen whether or not this type of indication is shown.

indicates that the measurement has ended because the residual noise floor limit was reached. In the general setup it can be chosen whether or not this type of indication is shown.

Pointing at the desired graph and then using the scroll

Right clicking on the DP-Gram graph provides the following

Add an additional frequency after testing of the original

Next measurement point interrupts the automatic test

Measure only selected frequency results in re-testing the

DPOAE norm data allows you to change which DP norm

Right clicking on the DP-I/O graph provides the following

wheel of your mouse allows zooming in and out on the Response and DP-Gram graph. Once zoomed in on, the graph then can be dragged in respect to the frequency axis.

options:

The scroll wheel of your mouse allows zooming in and out with respect to the frequency axis. Additionally you can Zoom in, Zoom out or Restore view by selecting the appropriate item from the right mouse click menu.

protocol has finished. Point and right click your mouse at the frequency that you would like to test. Click on Add then select an available frequency from the list to measure. After adding one or more frequencies you will notice that the Start button changes to say Continue. Clicking Continue will measure all inserted frequencies without a time limit. Press Stop when the additional points are sufficiently tested.

procedure and forces the device to start testing the next frequency immediately. This function is available when max test point has been selected in the protocol.

currently selected measurement point only. Select a measurement point to re-test by right clicking on it. A black circle around the measurement point indicates that it is selected. After pressing Continue (where the Start button was) the selected point will be tested without a time limitation. Press Stop to stop testing.

data is shown in the DP-Gram.

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options:

Add an additional level after testing of the original protocol

Next measurement point interrupts the automatic test

Measure only selected level results in re-testing the

The minimum test requirements as defined in the protocol

The Point Summary table displays the f2 test frequencies,

When the stimulus level goes outside the tolerance set in the

Screening protocol results can be PASS, REFER or

has finished. Point and right click your mouse at the frequency that you would like to test. Click on Add then select an available level to additionally measure. After adding one or more levels you will notice that the Start button changes to say Continue. Clicking Continue will measure all inserted levels without a time limit. Press Stop when the additional points are sufficiently tested.

procedure and forces the Lyra to start testing at the next intensity immediately. This function is available when max test point has been selected in the protocol.

are displayed beside some of the items in the Test summary table. These numbers in parentheses change to a check mark when the minimum requirement has been met during testing.

DP level, Noise, SNR and Reliability percentage. The Detected column displays a check mark when the specified frequency has met the criteria as setup in the protocol.

DP level, Noise and SNR values are rounded based on raw data. Therefore, the calculated SNR value displayed may not always equal the DP level minus the Noise.

protocol setup, the stimulus levels outside tolerance pop- up dialogue will appear on screen.

Press Stop to stop testing. Press Skip if you want to continue testing without the frequency for which this message appeared.

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INCOMPLETE and are indicated above the measurement.

The statistical significance of the detected result is dependent upon a combination of the following user defined settings in the protocol setup: Test time, Stimulus levels, SNR, Min DP level, DP tolerance, Reliability, Number of points required for a pass, Mandatory points required for a pass.

Using the TEOAE module

4.5.1 Preparing for the Test

Patient Instruction

• The aim of the test is to screen the hearing organ for its functionality

• The tip of the probe will be inserted into the ear canal and has to make a good seal

• Multiple tones will be heard during the test

• No participation is expected from the patient

• Coughing, moving, talking and swallowing will disturb OAE test results

Visual inspection of the ear canal

Check the external ear canal for wax with an otoscope and remove excessive wax to prevent the probe opening from clogging which will inhibit testing. Excessive hairs may have to be cut. If contraindications exist the patient should be inspected by ENT or medical specialist.

Prepare the equipment

1. Turn on Lyra by connection the USB to the PC.

™

2. Open the OtoAccess

3. Double click on the IA OAE Suite software. icon to launch the software and click on the OAE module tab TE.

4. Select the desired test protocol from the dropdown list.

5. Select the ear for testing.

Before conducting the OAE test, ensure that the probe tip is clean and free of wax and/or debris.

Test environment always conduct the OAE test in a quiet test environment, high ambient background noise will affect the OAE recording.

6. Select an ear tip size that will ensure a good seal in the ear canal.

7. Check the probe check status in the software to verify a good seal.

or Noah database and enter new patient details.

When the probe is detected to be Out of ear the color is red, In ear the color is green.

When Blocked or Too Noisy the colored bar is amber.

8. Results for TE response testing, OAE present right side and no OAE response left side.

The ear side symbol and color is written on the top of the graph. The checkmarks indicates the TE bars there have met the DP criteria as set in the protocol, as show

above for the right ear. The TE bars having no checkmark did not meet the TE criterion and can be either below the noise or absent. The grey area is the background noise in the TE test.

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Menu provides access to Setup, Print, Edit or Help (refer to the Guidance button opens the user guide which shows instructions

Print allows for printing the onscreen results directly to your default

Print to PDF icon appears when setup via the General Setup. This Save & New Session saves the current session in Noah 4 or

Save & Exit saves the current session in Noah 4 or OtoAccess™ Toggle Ear changes from right to left ear and vice versa in all

List of Defined Protocols allows for selecting a test protocol for

document for more details about protocols).

4.5.2 Element in the TEOAE module

The following section describes the elements of the TEOAE screen.

Additional Information document for more details about the menu items).

for testing within the module. The guidance can be personalized in the User guide setup window.

printer. You will be prompted to select a print template if the protocol does not have one linked to it (refer to the Additional Information document for more details about the print wizard).

allows for printing directly to a PDF document that is saved to the PC. (Refer to the Additional Information document for setup information).

OtoAccess™ (or to a commonly used XML file when running in standalone mode) and opens a new session.

(or to a commonly used XML file when running in standalone mode) and exits the OAE software.

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modules.

the current test session (refer to the Additional Information

Temporary setup allows for making temporary changes to the

List of historical sessions accesses historical sessions for review

Go to current session takes you back to the current session.

Probe status is shown by a colored bar with description next to it.

Summary view toggles between displaying result graph or result

Monaural/Binaural view toggles between showing the results of a

Report editor button opens a separate window for adding and

The Acceptable noise level slider allows setting the acceptable

The hardware indication picture indicates whether the Lyra or

Before testing, the Timer symbol indicates after how much time the

selected protocol. The changes will be valid for the current session only. After making the changes and returning to the main screen, the name of the protocol will be followed by an asterisk (*).

or the Current Session.

The historical session box can be expanded by dragging downwards with the mouse or minimized/maximized by clicking on the arrow button.

The session highlighted in orange, is the selected session displayed on screen. Check the checkbox next to the session date to overlay historic sessions on the graph.

graph with test summary tables.

single ear or both ears.

saving notes to the current or historic session.

noise level limit between +30 and +60 dB SPL. Sweeps recorded above the set acceptable noise level are considered to be too noisy and are rejected.

The VU meter indicates the current noise level and becomes amber in color when exceeding the set level.

Eclipse hardware is connected. Simulation mode is indicated when operating the software in simulation mode (user chosen).

TEOAE test will automatically stop. During testing the timer counts down to zero. You can disable the countdown by clicking on the timer during testing. As a result the timer will begin counting up and indicate how much test time has passed. Then the test will continue until you manually press stop.

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When the measurement is rejecting, the timer will stop counting.

The protocol listing shows all tests that are part of the selected

A checkmark in the box indicates that the test will run when

A white checkmark indicates that (at least some) data for this test

Pause becomes active after testing has started. It allows for

START (and STOP) button are used for starting and stopping the

The SNR (Signal-to-noise ratio) is displayed within each of the

Pointing at the desired graph and then using the scroll wheel of

It is possible to change the view of the TE response graph by right

start counting without a time limitation. Press Stop to stop testing.

Artifact rejection is dependent upon the Acceptable Noise Level setting and Level tolerance level set in the protocol.

protocol. The test that is displayed in the test screen area is highlighted blue or red, depending on the chosen ear.

is stored in the memory.

pausing during a test.

session.

frequency bands tested and is calculated in dB.

Hovering the mouse over a frequency band shows details about the ongoing or finished measurement.

your mouse allows zooming in and out on all graphs.

clicking. The dropdown menu gives the following options:

View allows you to change from the Original view to FFT view, 1/1, 1/2, 1/3, 1/6 and 1/12 octave band display.

Extend test allows continued testing after the test has ended on its

own or been manually stopped. The counter will revert to 0 and

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The response waveform along with the recording window and

Right clicking on the response waveform graph allows for

Norm data allows you to change which TE norm data is displayed

in the TE response graph.

response reproducibility range are shown.

The arrows indicate the recording window start and stop time. The area outside the recording window is grayed out. The recording window start and stop time can be changed prior to starting a test by moving the arrows on the graph with the mouse,

The waveform reproducibility window range is indicated by a black line on the x axis. Only the waveform within this range accounts for the calculation of the waveform reproducibility

percentage.

Clicking on the aqua or purple circles at the end of each waveform

and moving the mouse, allows for separation of the curves within the graph

changing the display.

View buffers A & B is the default view showing the two superimposed averaged OAE waveforms. View noise displays the noise in the waveform (Noise = A buffer – B buffer). View average displays the mean of the A and B waveforms.

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The minimum test requirements as defined in the protocol are

The Band Summary table displays the test frequencies, TE level,

When the stimulus level goes outside the tolerance set in the

Screening protocol results can be PASS, REFER or

required for a pass.

displayed beside some of the items in the Test summary table. These numbers in parentheses change to a check mark when the minimum requirement has been met during testing.

Noise, SNR. The Detected column displays a check mark when the specified frequency has met the criteria as setup in the protocol.

TE level, Noise and SNR values are rounded based on raw data. Therefore, the calculated SNR value displayed may not always equal the TE level minus the Noise.

protocol setup, the stimulus levels outside tolerance pop-up dialogue will appear on screen.

Press Stop to stop testing. Press Skip if you want to continue testing without the frequency for which this message appeared.

INCOMPLETE and are indicated above the measurement.

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2 3 4

12a

12b

Using the Print Wizard

In the Print Wizard you have the option to create customized print templates which can be linked to individual protocols for quick printing. The Print Wizard can be reached in two ways.

a. If you want to make a template for general use, or select an existing one for printing: Go to Menu |

Print | Print wizard… in any of the IA OAE Suite software tabs (DPOAE, TEOAE)

b. If you want to make a template or select an existing one to link to a specific protocol: Go to Module

tab (DPOAE, TEOAE) relating to the specific protocol and select Menu | Setup | Protocol setup. Select the specific protocol from the drop down menu and select Print Wizard at the bottom of the window

Now the Print Wizard window opens and shows the following information and functionalities:

1. Categories you can select:

• Templates to show all available templates

• Factory defaults to show only standard templates

• User defined to show only custom templates

• Hidden to show hidden templates

• My favorites to show only templates marked as a favorite

2. Available templates from the selected category are shown in the Templates viewing area.

3. Factory default templates are recognized by the lock icon. They ensure that you always have a standard template and do not need to create a customized one. However, they cannot be edited according to personal preferences without resaving with a new name. User defined/created templates can be set to Read-only (showing the lock icon), by right clicking on the template and selecting Read-only from the drop down list. Read-only status can also be removed from User defined templates by following the same steps.

4. Templates added to My favorites are marked with a star. Adding templates to My favorites allows quick viewing of your most commonly used templates.

5. The template that is attached to the selected protocol when entering the print wizard via the DPOAE or TEOAE window is recognized by a checkmark.

6. Press the New Template button to open a new empty template.

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7. Select one of the existing templates and press the Edit Template button to modify the selected layout.

8. Select one of the existing templates and press the Delete Template button to delete the selected template. You will be prompted to confirm that you want to delete the template.

9. Select one of the existing templates and press the Hide Template button to hide the selected template. The template will now be visible only when Hidden is selected under Categories. To unhide the template, select Hidden under Categories, right click on the desired template and select View/Show.

10. Select one of the existing templates and press the My Favorites button to mark the template as a favorite. The template can now be quickly found when My Favorites is selected under Categories. To remove a template marked with a star from My Favorites, select the template and press the My Favorites button.

11. Select one of the templates and press the Preview button to print preview the template on screen.

12. Depending how you reached the Print Wizard, you will have the option to press

a. Print for using the selected template for printing or press b. Select for dedicating the selected template to the protocol from which you got into the Print

Wizard

13. To leave the Print Wizard without selecting or changing a template press Cancel.

Right clicking on a specific template provides a drop down menu offering an alternative method for performing the options as described above:

More detailed information about the Print Wizard can be found in the Lyra Additional Information document.

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5 Maintenance

General maintenance procedures

The performance and safety of the instrument will be maintained if the following recommendations for care and maintenance are observed:

1. It is recommended that the instrument go through at least one annual service, to ensure that the acoustical, electrical and mechanical properties are correct. This should be carried out by an authorized technician in order to guarantee proper service and repair.

2. Observe that no damage is present to the insulation of the mains cable or the connectors and that it is not exposed to any kind of mechanical load that could involve damage.

3. To ensure that the reliability of the instrument is maintained, we recommend that the operator at short intervals, for instance once a day, performs a test on a person with known data. This person could be the operator.

4. If the surface of the instrument or parts of it is contaminated, it can be cleaned using a soft cloth moistened with a mild solution of water and detergent or similar. Always disconnect the USB connection during the cleaning process, and be careful that no fluid enters the inside of the instrument or accessories.

5. After each patient examination, ensure that there has been no contamination to the parts touching the patient. General precautions must be observed in order to avoid cross-contamination of disease from one patient to another. Water should be used for frequent cleaning, but in the case of severe contamination it may be necessary to use a disinfectant.

General maintenance procedures

• Before cleaning always switch off and disconnect from the power supply (PC)

• Use a soft cloth lightly dampened with cleaning solution to clean all exposed surfaces

• Do not allow liquid to come in contact with the inner parts inside the OAE probe

• Do not autoclave, sterilize or immerse the instrument or accessory in any fluid

• Do not use hard or pointed objects to clean any part of the instrument or accessory

• Do not let parts that have been in contact with fluids dry before cleaning

• Rubber ear-tips or foam ear-tips are single use components

• Ensure that isopropyl alcohol does not come into contact with any connection parts or rubber parts

Recommended cleaning and disinfection solutions:

• Warm water with mild, nonabrasive cleaning solution (soap)

• 70% isopropyl alcohol only on hard cover surfaces

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OAE probe

1. Unscrew the probe cap.

2. Remove the probe tip.

3. Thread the stiff end of the cleaning floss

4. Pull the cleaning floss completely through

5. Assemble the probe again.

Notice:

Cleaning the probe tip

In order to secure correct measurements it is important to make sure that the probe system is kept clean at all times. Therefore please follow the below illustrated instructions on how to remove e.g. cerumen from the small acoustic and air pressure channels of probe tip.

into one of the tubes.

the probe tip tube. Clean each of the tubes as required. Discard floss after use.

Do not use the cleaning tool to clean the probe base. This will destroy the acoustic filters.

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Concerning repair

Interacoustics is only considered to be responsible for the validity of the CE marking, effects on safety, reliability and performance of the equipment if:

1. assembly operations, extensions, readjustments, modifications or repairs are carried out by authorized persons,

2. a 1 year service interval is maintained

3. the electrical installation of the relevant room complies with the appropriate requirements, and

4. the equipment is used by authorized personnel in accordance with the documentation supplied by Interacoustics.

It is important that the customer (agent) fills out the RETURN REPORT every time a problem arises. This should also be done every time an instrument is returned to Interacoustics. (This of course also applies in the unlikely worst case scenario of death or serious injury to a patient or user).

Warranty

Interacoustics guarantees that:

• The Lyra is free from defects in material and workmanship under normal use and service for a period of 24 months from the date of delivery by Interacoustics to the first purchaser

• Accessories are free from defects in material and workmanship under normal use and service for a period of ninety (90) days from the date of delivery by Interacoustics to the first purchaser

If any product requires service during the applicable warranty period, the purchaser should communicate directly with the local Interacoustics service center to determine the appropriate repair facility. Repair or replacement will be carried out at Interacoustics’ expense, subject to the terms of this warranty. The product requiring service should be returned promptly, properly packed, and postage prepaid. Loss or damage in return shipment to Interacoustics shall be at purchaser's risk.

In no event shall Interacoustics be liable for any incidental, indirect or consequential damages in connection with the purchase or use of any Interacoustics product.

This shall apply solely to the original purchaser. This warranty shall not apply to any subsequent owner or holder of the product. Furthermore, this warranty shall not apply to, and Interacoustics shall not be responsible for, any loss arising in connection with the purchase or use of any Interacoustics product that has been:

• repaired by anyone other than an authorized Interacoustics service representative

• altered in any way so as, in Interacoustics opinion, to affect its stability or reliability

• subject to misuse or negligence or accident, or that has had the serial or lot number altered,

defaced or removed; or

• improperly maintained or used in any manner other than in accordance with the instructions provided by Interacoustics

This warranty is in lieu of all other warranties, express or implied, and of all other obligations or liabilities of Interacoustics. Interacoustics does not give or grant, directly or indirectly, the authority to any representative or other person to assume on behalf of Interacoustics any other liability in connection with the sale of Interacoustics products.

INTERACOUSTICS DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FOR FUNCTION OF FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION.

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Approval of the quality system is made by TÜV – identification no0123

Standards

Safety:

IEC 60601-1:2005, A1:2012 Type B applied parts

EMC:

IEC 60601-1-2:2014

Test signal:

IEC 60645-1:2012 /ANSI S3.6 , IEC 60645-3: 2007

DPOAE IEC 60645-6:2009, Type 2 Otoacoustic emissions

Operation environment

Temperature:

15°-35°C

Relative humidity:

30-90%

Ambient pressure:

98 kPa-104 kPa

Boot time

Less than 2 seconds

Warm-up time:

Less than 2 seconds

Relative humidity:

10-95%

Maximum 470 mA

a PC.

Dimensions

8 x 18 x 2 cm (cable length 112 cm)

Lyra weight

165 gram incl. OAE probe

DPOAE

Stimulus

Frequency range:

500 to 10000 Hz

Nominal frequency:

f2 Frequency step:

1 Hz Level:

30 to 70 dB SPL (30 to 65 dB SPL for 8 kHz to 10 kHz)

Level step:

1 dB

Recording

Analysis time:

1 second to unlimited time

A/D resolution:

24 bit, 5.38 Hz resolution

Artifact rejection system:

-30 to +30 dB SPL or off

Stimulus tolerance:

Adjustable between 1 and 10 dB

SNR criteria:

Adjustable between 3 and 25 dB

DP criteria:

SNR, Min DP level, DP tolerance, Residual noise, mandatory points, DP reliability

Probe check window:

256 points frequency response of the ear canal due to a click stimulus.

DP-response window:

4096 points frequency response

Residual noise:

A RMS average measurement in the DP-bin frequency area (26 bins at frequencies < 2500 Hz & 60 bins ≥ 2500 Hz).

Display

Other information:

In ear status (before/after test) and noise rejection level

Basic or advanced view of the DP-Gram, test summary table, point summary table

Probe specifications

Lyra OW A probe:

Combined DPOAE and TEOAE OWA probe

Replaceable probe tip

6 General technical specifications

Lyra Hardware – technical specifications

Medical CE-mark The CE-mark indicates that Interacoustics A/S meets the requirements of Annex II of the Medical

OAE: TEOAE IEC 60645-6:2009, Type 1 & 2 Otoacoustic emissions

Device Directive 93/42/EEC.

Transport & Storage Storage temperature:

Transport temperature:

Power Powered trough USB 5V

PC control USB: Input/output for computer communication. Lyra is fully operated from

0°C-50°C

-20°-50 °C

Minimum 330 mA Typical 420 mA

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TEOAE

Stimulus

Frequency range:

500 to 5500 Hz

Frequency step:

1 Hz (Custom bands)

Stimulus type:

Non-Linear (according to IEC 60645-3)

Level:

30 to 90 dB peSPL, peak to peak calibrated, AGC controlled

Level step:

1 dB

Click rate:

43.5 or 80 Hz

Stimulus tolerance:

Adjustable between 1 and 3 dB

Recording

Analysis time:

30 seconds to 30 minutes or 300 to 30000 sweeps

A/D Resolution:

24 bit

Artifact rejection system:

0 to +60 dB SPL

SNR criteria:

Adjustable between 5 and 25 dB

TE criteria:

SNR, min sweeps, min Total OAE, min TE level, mandatory bands

Stimulus time window:

128 points instant recording of first click in sequence of clicks

Probe check window:

256 points frequency response of the ear canal recorded click stimulus

11025 Hz

window:

average for the defined OAE time window

level

summary table

Probe specifications

Lyra OWA probe:

Combined DPOAE and TEOAE OWA probe

Replaceable probe tip

Time recording window: 4-23 msec (max). A and B buffer time-samples @ sampling rate

Frequency response

Residual noise: A RMS value for each octave band, based on the Bayesian weighted

Display Other information: In ear status (active before, during & after test) and noise rejection

256 points frequency response, bin spacing 43 Hz

Basic or advanced view, FFT view, test summary table, band

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Lyra Maximums DPOAE

Center Freq. [Hz]

IPSI

ch2

Reading

Reading Tone

Tone

[dB SPL]

500

750

1000

1500

2000

3000

4000

6000

8000

65 10000

Specification of input/output connections

Inputs

Connector type

Electrical properties

Data I/O

USB

USB type”B”

USB port for communication

Table 1: Frequencies and intensity ranges for DPOAE

Lyra Maximum TEOAE level

Maximum TEOAE Click Intensity: 90 dB peSPL.

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Calibrated Transducers

Probe system:

Probe frequency transmitter and receiver are integrated in the probe system

Accuracy

General:

Generally the instrument is made and calibrated to be

specified standards:

DPOAE levels:

±1.5 dB for 1000 to 4000 Hz and ±3 dB outside range

±2 dB for click stimulus

Calibration properties

within and better than the tolerances required in the

TEOAE levels:

Coupler types used for calibration

DPOAE:

Probe stimuli L1 and L2 are calibrated individually in SPL values using the IEC 711 ear simulator coupler made in accordance to IEC 60318-4.

TEOAE:

Probe stimuli are calibrated in peSPL values using the IEC 711 ear simulator coupler made in accordance to IEC 60318-4.

General information about specifications

Interacoustics continuously strives to improve its products and their performance. Therefore the specifications can be subject to change without notice. The performance and specifications of the instrument can only be guaranteed if it is subject to technical maintenance at least once per year. This should be carried out by a workshop authorized by Interacoustics.

Interacoustics puts diagrams and service manuals at the disposal of authorized service companies.

Enquiries about representatives and products may be sent to: Interacoustics A/S Phone: +45 63713555 Audiometer Allé 1 Fax: +45 63713522 5500 Middelfart E-mail: info@interacoustics.com Denmark http: www.interacoustics.com

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Electromagnetic compatibility (EMC)

• This instrument is suitable in hospital environments except for near active HF surgical equipment and RF shielded rooms of systems for magnetic resonance imaging, where the intensity of electromagnetic disturbance is high

• Use of this instrument adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this instrument and the other equipment should be observed to verify that they are operating normally

• Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. The list of accessories, transducers and cables can be found in this appendix.

• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of this instrument, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result

NOTICE ESSENTIAL PERFORMANCE for this instrument is defined by the manufacturer as:

• This instrument does not have an ESSENTIAL PERFORMANCE Absence or loss of ESSENTIAL PERFORMANCE cannot lead to any unacceptable immediate risk

• Final diagnosis shall always be based on clinical knowledge There are no deviations from the collateral standard and allowances uses

• This instrument is in compliance with IEC60601-1-2:2014, emission class B group 1

NOTICE: There are no deviations from the collateral standard and allowances uses NOTICE: All necessary instruction for maintaining compliance with regard to EMC can be found in the general maintenance section in this instruction. No further steps required.

D-0119867-C – 2019/03 Lyra - Instructions for Use - EN Page 45

Guidance and manufacturer’s declaration - electromagnetic emissions

The LYRA is intended for use in the electromagnetic environment specified below. The customer or the user of the LYRA should assure that it is used in such an environment.

Emissions Test

Compliance

Electromagnetic environment - guidance

RF emissions

Group 1

The LYRA uses RF energy only for its internal function.

interference in nearby electronic equipment.

RF emissions CISPR 11

Class B

The Lyra is suitable for use in all commercial, industrial, business, and

Harmonic emissions IEC 61000-3-2

Complies Class A Category

Voltage fluctuations /

IEC 61000-3-3

Complies

Recommended separation distances between portable and mobile RF communications equipment and the Lyra.

The Lyra is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of

communications equipment.

Rated Maximum output

Separation distance according to frequency of transmitter [m]

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

0.01

0.12

0.23

0.1

0.37

0.74 1 1.17

1.17

2.33

3.70

7.37

100

11.70

23.30

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated

objects and people.

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

The Lyra is intended for use in the electromagnetic environment specified below. The customer or the user of the Lyra should assure that it is used in such an environment.

Immunity Test

IEC 60601 Test level

Compliance

Electromagnetic Environment-Guidance

Electrostatic Discharge

+6 kV contact

Floors should be wood, concrete or Electrical fast

+2 kV for power supply lines

Mains power quality should be that of a

Surge

+1 kV differential mode

Mains power quality should be that of a

Voltage dips, short

< 5% UT

(>95% dip in UT) for 5 sec

< 5% UT (>95% dip in UT)

Mains power quality should be that of a

Portable and mobile RF communications equipment can affect the Lyra. Install and operate the Lyra according to the EMC information presented in this chapter. The Lyra has been tested for EMC emissions and immunity as a standalone Lyra. Do not use the Lyra adjacent to or stacked with other electronic equipment. If adjacent or stacked use is necessary, the user should verify normal operation in the configuration. The use of accessories, transducers and cables other than those specified, with the exception of servicing parts sold by Interacoustics as replacement 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.

CISPR 11

flicker emissions

the Lyra can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Lyra as recommended below, according to the maximum output power of the

power of transmitter [W]

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 higher frequency range applies. Note 2 These guidelines may not apply to all situations. Electromagnetic propagation is affected by absorption and reflection from structures,

d = 1.17√

Therefore, its RF emissions are very low and are not likely to cause any

residential environments.

d = 1.17√

d = 2.23√

(ESD)

IEC 61000-4-2

transient/burst

IEC61000-4-4

IEC 61000-4-5

interruptions and voltage variations on power supply lines

IEC 61000-4-11

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+8 kV air

+1 kV for input/output lines

+2 kV common mode

(>95% dip in UT) for 0.5 cycle

40% UT (60% dip in UT) for 5 cycles

70% UT (30% dip in UT) for 25 cycles <5% UT

+8 kV air

+1 kV for input/output lines

+2 kV common mode

for 0.5 cycle

40% UT (60% dip in UT) for 5 cycles

70% UT (30% dip in UT) for 25 cycles <5% UT

ceramic tile. If floors are covered with synthetic material, the relative humidity should be greater than 30%.

typical commercial or residential environment.

typical commercial or residential environment. If the user of the Lyra requires continued operation during power mains interruptions, it is recommended that the Lyra be powered from an uninterruptable power supply or its battery.

Power frequency (50/60

3 A/m

Power frequency magnetic fields should

Note: UT is the A.C. mains voltage prior to application of the test level.

Guidance and manufacturer’s declaration — electromagnetic immunity

The Lyra is intended for use in the electromagnetic environment specified below. The customer or the user of the Lyra should assure that it is used in such an environment,

Immunity test

IEC / EN 60601 test level

Compliance level

Electromagnetic environment – guidance

Portable and mobile RF communications

d 2,

NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies

objects and people.

(a)

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Description

Length

Screened

OAE cable

2.0 m

Screened

USB Cable

2.0 m

Screened

Hz)

IEC 61000-4-8

Conducted RF IEC / EN 61000-4-6

Radiated RF IEC / EN 61000-4-3

3 Vrms 150kHz to 80 MHz

3 V/m 80 MHz to 2,5 GHz

3 Vrms

3 V/m

be at levels characteristic of a typical location in a typical commercial or residential environment.

equipment should be used no closer to any parts of the Lyra, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

80 MHz to 800

MHz

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 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,

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 the measured field strength in the location in which the Lyra is used exceeds the applicable RF compliance level above, the Lyra should be observed to verify normal operation, If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Lyra.

(b)

Conformance to the EMC requirements as specified in IEC 60601-1-2 is ensured if the cable types and cable lengths are as specified below:

D-0119867-C – 2019/03 Lyra - Instructions for Use - EN Page 47

Opr. dato: af:

2014-03-07 EC

Rev. dato: 2015-04-15 af:

MSt

Rev. nr.:

Return Report – Form 001

Company:

Address:

Phone:

Address DGS Diagnostics Sp. z o.o.

ul. Sloneczny Sad 4d 72-002 Doluje Polska

Fax or e-mail:

Contact person:

Following item is reported to be:

returned to INTERACOUSTICS for: defective as described below with request of assistance repaired locally as described below showing general problems as described below

Item: Type: Quantity:

Description of problem or the performed local repair:

Returned according to agreement with:

Please provide e-mail address or fax No. to whom Interacoustics may confirm reception of the returned goods:

The above mentioned item is reported to be dangerous to patient or user

In order to ensure instant and effective treatment of returned goods, it is important that this form is filled in and placed together with the item. Please note that the goods must be carefully packed, preferably in original packing, in order to avoid damage during transport. (Packing material may be ordered from Interacoustics)

EC Medical Device Directive rules require immediate report to be sent, if the device by malfunction deterioration of performance or characteristics and/or by inadequacy in labelling or instructions for use, has caused or could have caused death or serious deterioration of health to patient or user.Page 1 of

Included parts:

Date : Person :

repair,

exchange, other:

Serial No.: Supplied by:

Important! - Accessories used together with the item must be included if returned (e.g. external power supply, headsets, transducers and couplers).

Interacoustics, Other :

Date:

Interacoustics Lyra Instructions For Use Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

1 Introduction

About this manual

Intended use

Contraindications

Product description

Warnings

2 Unpacking and installation

Unpacking and Inspection

Definition of symbols

Safety precautions

2.3.1 Cautions - general

2.3.2 Environmental factors

2.3.3 Electrical safety

2.3.4 Electromagnetic compatibility (EMC)

2.3.5 Explosion hazards

Connecting the Lyra to the PC/laptop

2.4.1 Powering the Lyra

2.4.2 Data storage

Safety precautions to take when connecting the Lyra to PC/laptop.

IA OAE Suite software installation

Installation of the driver

Standalone installation of IA OAE Suite software

License

3 Operating instructions

Handling and selection of ear tips

Probe test for TEOAE

3.2.1 Performing the Probe Test

3.2.2 Functioning probe

3.2.3 Faulty probe

4 The IA OAE Suite

PC power configuration

Compatible devices

4.2.1 Starting from OtoAccess™

4.2.2 Starting from Noah 4

4.2.3 Simulation mode

4.2.4 Crash report

Using the menu

Using the DPOAE module

4.4.1 Preparing for the test

4.4.2 Elements in the DPOAE module

Using the TEOAE module

4.5.1 Preparing for the Test

4.5.2 Element in the TEOAE module

Using the Print Wizard

5 Maintenance

General maintenance procedures

General maintenance procedures

Cleaning the probe tip

Concerning repair

Warranty

6 General technical specifications

Lyra Hardware – technical specifications

Calibration properties

Electromagnetic compatibility (EMC)