Titan
Titan
Titan
Titan
4 Maintenance ...................................................................................................................................... 83
General maintenance procedures ............................................................................................... 83
Cleaning the probe tip ................................................................................................................. 84
Concerning repair ........................................................................................................................ 85
Warranty ...................................................................................................................................... 85
Interacoustics A/S
Audiometer Alle 1
5500 Middelfart
Denmark
Tel.: +45 6371 3555
Fax: +45 6371 3522
E-mail: [email protected]
Web: www.interacoustics.com
Intended use
The Titan with IMP440 Impedance System is an electroacoustic test instrument that produces controlled
levels of test tones and signals intended for use in conduction diagnostic hearing evaluations and assisting in
the diagnosis of possible otologic disorders. It features tympanometry and acoustic reflexes. It also
measures various acoustic properties of the ear, namely power reflectance, power absorption, transmittance,
reflectance group delay, complex acoustic impedance and admittance, and equivalent ear canal volume.
These measures allow the evaluation of the functional condition of the middle and outer ear.
The target population for Titan with IMP440 includes all ages.
The Titan with DPOAE440 is intended for use in the audiologic evaluation and documentation of ear
disorders using Distortion Product Otoacoustic Emissions. The target population for Titan with DPOAE440
includes all ages.
The Titan with ABRIS4401 is intended for use in the audiologic evaluation and documentation of ear and
nerve disorders using auditory evoked potentials from the inner ear, the auditory nerve and the brainstem.
The target population for Titan with ABRIS440 is newborns.
The Titan with TEOAE440 is intended for use in the audiologic evaluation and documentation of ear
disorders using Transient Evoked Otoacoustic Emissions. The target population for Titan with TEOAE440
includes all ages.
The Titan 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.
Product description
The Titan is a multifunctional screening and/or diagnostic device that interfaces with integrated audiologic
software modules on a PC or can be operated as a standalone handheld device. Depending on the installed
software modules, it can perform:
• Impedance and Wide Band Tympanometry (IMP440/WBT440)
• Distortion Product Otoacoustic Emissions (DPOAE440)
• Automated Auditory Brainstem Responses (ABRIS440) 1
• Transient Evoked Otoacoustic Emissions (TEOAE440)
1 This license and corresponding hardware may not be available in your region.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 1
The system consists of the following included and optional parts:
TDH39C contra cup headset (ID plug)2 Optional n/a n/a n/a
DD45C contra cup headset (ID plug)2 Optional n/a n/a n/a
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 2
E-A-RTONE 3A insert contra (ID plug)2 Optional* n/a n/a n/a
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 3
1.3.1 Probe, transducers and cable configurations
Titan operates with different transducers and cable configurations. The table below shows which transducers
and cable configurations are possible for use with the Titan.
Detachable probe directly connected Not permitted Not permitted Not permitted Not permitted
to preamplifier
Available contra phones for use with the Long Clinical Extension Cable (shoulder box):
CIR55 (insert)
E-A-RTONE 3A (single insert) (US only)
TDH39 (single headphone)
DD45 (single headphone)
IP30 contra with minijack
To run contralateral reflex measurements via the preamplifier cable, you will need a contra phone ID
transducer using the omnetics plug. The contra phone that connects to the (IMP/OAE) shoulder box uses a
different plug and is not compatible with the preamplifier cable. Please contact your distributor if you require
a preamplifier cable compatible contralateral headset (ID transducer).
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 4
Warnings
Throughout this manual the following meanings of warnings, cautions and notices apply:
Data protection
The General Data Protection Regulation (GDPR) that came into force on May 25, 2018 and stipulates how
patient data is handled and stored. The Titan device, together with the Titan Suite software module is used
to test patients, store and view measurement data. It is the customer’s responsibility to ensure that the way
you use the software and device and how you share information within your organization and with third
parties is complaint with the guidelines set out in the GDPR.
It is also the customer’s responsibility to clean up any computer where the Titan Suite is installed or any
Titan device where patient data is present prior to disposal, in accordance with the GDPR guidelines.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 5
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 6
2 Unpacking and installation
Unpacking and inspection
Check box and contents for damage
When the instrument is received please check the shipping box for rough handling and damage. If the box is
damaged it should be kept until the contents of the shipment have been checked mechanically and
electrically. If the instrument is faulty please contact your local distributor. Keep the shipping material for the
carrier’s inspection and insurance claim.
Reporting Imperfections
Inspect before connection
Prior to connecting the product it should once more be inspected for damage. All of the cabinet and the
accessories should be checked visually for scratches and missing parts.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 7
Markings
The following markings can be found on the instrument.
Please note that only safety symbols are visible on the Titan device. The remaining regulatory information is
found in the battery compartment (see section 2.10).
Symbol Explanation
WEEE (EU-directive)
This symbol indicates that when the end-user wishes to discard this product,
it must be sent to separate collection facilities for recovery and recycling.
Failing to do so may endanger the environment.
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.
0123
Serial number.
Date of manufacture.
Manufacturer.
Reference number.
Do not re-use.
Parts like ear-tips and similar are for single use only.
Keep dry.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 8
Hardware installation
When connecting the Titan to the mains supply and to a 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 in 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 a qualified medical technician or your local representative. If the instrument is
connected to a PC (IT equipment forming a system) ensure not to touch the patient while operating
the PC.
2. If the instrument is connected to a PC (IT equipment forming a system) assembly and modifications
shall be evaluated by a qualified medical technician according to safety regulations in IEC 60601.
3. Note! The USB connection on the instrument has insulation protections to the patient connections.
4. The consequence of not following this precaution could be a too high leakage current to the patient.
5. Before connection to the mains network, be sure that the local mains voltage corresponds to the
voltage labeled on the instrument. Always disconnect the power cord if the instrument is to be
opened for inspection.
6. For maximum electrical safety, turn off the power from a mains powered instrument when it is left
unused.
7. In order to maintain a high level of safety it is necessary to have the instrument and its power supply
checked according to the medical electrical safety standard IEC 60601-1 on a yearly basis by a
qualified service technician.
8. Do not disassemble or modify the product as this may impact on the safety and/or performance of
the device.
9. No parts of the equipment can be serviced or maintained while in use with the patient.
NOTICE
1. DO NOT connect the Titan hardware to the computer before the software has been installed!
2. Storage in temperatures below 0°C /32°F and above 50°C /122°F may cause permanent damage to
the instrument and its accessories.
3. Do not place the instrument next to a heat source of any kind and allow sufficient space around the
instrument to ensure proper ventilation.
4. Although the instrument fulfils 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, caution must be taken to observe that no mutual disturbance appears.
6 Great care should be exercised when handling transducers, as rough handling, for example dropping
onto a hard surface may break or damage the parts.
7. The best way to protect the Titan from ESD is to avoid the build-up of electrostatic charges through
the use of conductive footwear and floor coverings. Humidification of the air is also an effective
preventive means. Failing to comply with these measures can cause the build-up of voltage levels of
several thousand volts. If the Titan is subjected to such an ESD pulse, it may be necessary to
remove the battery for a few seconds and then restart the instrument.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 9
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.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 10
Installing the cradle
Slide off the back plate of the cradle.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 11
Place the steel cable holder into the holes provided on
the back of the cradle.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 12
Mounting a cradle on the wall
In order to mount the cradle to the wall you will need the following tools: a drill and a screwdriver.
You may need to find out which plugs and screws are best to use depending on the material of the wall.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 13
Cradle indication lights
The LEDs on the cradle indicate the following:
LED 1 will show a solid green light when the Titan is placed
inside the cradle and its battery is fully charged. LED 1 will
1 2 3 flash green while the battery is charging.
LED 2 will show a solid green light when the spare battery is
placed inside the cradle and is fully charged. LED 2 will flash
green while the battery is charging.
Do not use an ear tip! Place the probe tip completely into
the cavity. Perform the measurement. Check the volume
that was measured.
The allowed tolerance in the volume measurement is ± 0.1
ml for cavities up to 2 ml and ± 5% for larger cavities. These
tolerances are applicable for all probe tone frequencies.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 14
Installing the thermal printer
Ensure that the printer is properly installed and ready to use by following the Instructions for Use for the
printer.
If you want to print out measured results on a wirelessly connected thermal printer it is recommended to
switch on the printer before doing the measurements. This will allow the printer enough time to connect and
be ready for printing when measurements are completed.
NOTICE
Make sure the battery contacts line up with the contacts
inside the Titan battery compartment.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 15
2.9.1 Charging the battery
Typically, the Titan can perform the following number of continuous tests for the various modules:
The figures below have been calculated taking into consideration an average test time of 1 minute per test
for IMP, DPOAE and TEOAE. A test time of 3 minutes has been used to calculate the number of tests that
can be performed in ABRIS.
The Titan battery automatically starts charging when placed in the cradle if this is connected to mains power.
Keeping the spare battery in the cradle charging compartment means you will always have fully charged
spare battery.
Interacoustics provides a medically approved mains power supply to be used for charging the Titan. A DC
USB adaptor can be used to connect the Titan to the medically approved mains power supply when the
cradle is not in use. Then the battery in Titan is charged within the same time frame as if it was placed in the
cradle.
The Titan battery can also be charged via connection to a PC with a USB cable provided.
Testing can be performed while the Titan battery is charging.
The following table gives an estimate of the charging time (ct) in hours for the battery. Be aware that
negative numbers mean that the battery is discharging. Charge times for the spare battery in the cradle and
the battery in the Titan while placed in the cradle are the same.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 16
ct through cradle ct through USB ct through cradle ct through USB
up to 80% (PC) up to 80% up to 100% (PC) up to 100%
Off 1,5 3,8 2,3 5,7
On (not testing) 2,8 -32 4,1 -47
Note that the length of the tubing influences the pump speed in the IMP440 module. When the probe is
directly connected to the Titan, pump speeds are about 60% higher than when it is connected via the long
clinical extension cable (shoulder box) or preamplifier cable. For the most accurate measurements it is
recommended to use probe while connected via the long clinical extension cable (shoulder box) or
preamplifier cable.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 17
Connecting transducers to the shoulder box and preamplifier
You can only perform contralateral stimulation during impedance reflex measurements when the long clinical
extension cable (shoulder box) or preamplifier cable is connected to the Titan.
Placing and using the Long Clinical Extension Cable (Shoulder Box) or
preamplifier cable
The long clinical extension cable with the small shoulder box can be used for impedance and OAE
measurements. The preamplifier cable is required for ABRIS testing and can also be used with all other
modules.
Use the clip on the back of the long clinical extension cable (shoulder box) to attach it to the clothing of the
patient. For most patients it may be suitable to attach the shoulder box to the collar of their shirt/blouse. For
the preamplifier cable it may be more suitable to attach it to the strap which can then be placed around the
neck of the parent who is holding the patient.
The shoulder box button (1) can be used for operating the Titan
during and in between testing.
In between testing, when the probe is out of the ear, pressing the
button will change the selected ear from right to left and vice
versa.
2
The button (2) on the preamplifier can be used to START or
STOP a test.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 18
Placing the montage-indication stickers on the preamplifier
A sheet containing Montage-Indication stickers has been enclosed to provide assistance to the user for
correct placement of the electrodes and cables. Each sheet contains two stickers; the top one showing the
mastoid montage setup and the bottom one showing the nape montage setup.
Remove the required sticker from the sheet and attach inside the
recess on the back of the preamplifier.
Use of the IP30 or E-A-RTONE ABR transducer with ear tips, foam inserts or
EarCups (ABRIS440 only)
There are two versions of the IP30 / E-A-RTONE ABR transducer for use with the ABRIS440 module.
The IP30 / E-A-RTONE ABR transducer is for use The IP30/ E-A-RTONE Earcup transducer is for use
with the 3.5mm or 4.0mm infant ear tips, foam with EarCups via an adaptor. The transducer is
insert ear tips or the Titan probe ear tips via an labeled “Calibrated for use with EarCups”.
adaptor. The transducer is labeled “Calibrated for
use with inserts”.
NOTICE
Even though the transducers appear to be the same, ensure you are using the transducer with the
disposable it is calibrated for. Misuse may lead to incorrect results due to differences in the calibration.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 19
Safety Precautions to take when connecting the Titan
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 instructions below.
Fig 1. Titan used with the medically approved power supply and DC USB adaptor.
Fig. 2. Titan used with the cradle and the medically approved power supply
Fig. 3. Titan used with the cradle, medically approved power supply and a wireless printer.
Wireless
Fig. 4. Titan used with the cradle, medically approved power supply and a wireless connection to a
PC.
Wireless
Fig. 5. Titan used with the cradle, medically approved safety transformer and a wired connection to a
PC. Not suitable for ABRIS440 use as patient safety is not maintained – refer fig. 7.
Medical power supply Titan in cradle
Printer
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 20
Fig. 6. Titan used with the Cradle, medically approved safety transformer, wired connection to a PC,
and a wireless connection to a printer. Not suitable for ABRIS440 use as patient safety is not
maintained – refer fig. 7.
Wireless
Printer
Fig. 7. Titan used with the Cradle, medically approved power supply, optical USB connection to a PC,
and a wireless connection to a printer. Suitable configuration for use with ABRIS440 – patient safety is
maintained.
Wireless
Printer
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 21
Software installation
To know before you Start Installation
You must have administrative rights to the computer on which you are installing the Titan Suite.
Further information about the normative data can be obtained from the Titan Additional Information Manual
and from Interacoustics.
NOTICE
1. DO NOT connect the Titan hardware to the computer before the software has been installed!
2. Interacoustics will not make any guarantee to the functionality of the system if any other software is
installed, with exception of the OtoAccess® Database or Noah 4.10 or higher.
PC minimum requirements
• Core i3 CPU or better (Intel recommended)
• 4GB RAM or more
• Hard drive with min 10 GB free space (Solid State Drive (SSD) recommended)
• Minimum display resolution of 1280x1024 pixels
• DirectX 11.x compatible graphics (Intel/NVidia recommended)
• One or more USB ports, version 1.1 or higher
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.
To use the software in conjunction with a database (e.g. Noah or the OtoAccess® Database), make sure the
database is installed prior to the Titan Suite 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 Titan Suite.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 22
Software installation on Windows® 7, Windows® 8 and Windows® 10
Insert the installation USB and follow the steps below to install the Titan Suite software. If the installation
procedure does not start automatically, click “Start”, then go to “My Computer” and double click the USB
drive to view the contents of the installation USB. Double click the “setup.exe” file to initiate the installation.
1. Wait for the dialog shown below to appear, agree to the license terms and conditions, then click
“Install”.
2. Follow the onscreen Titan 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 Titan 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 Titan works as intended. If not installed, the Titan will not be
detected by the computer when connected via USB
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 23
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 Instruction for Use Manual (EN or US) of the
Titan Suite.
Note that all regional factory protocols will be available through the show/hide protocols option for each
separate module. Refer to the Titan Additional Information document for more details.
Note that the language can always be changed by selecting Menu | Setup | Language in the MAIN tab of
the Titan Suite after installation
1. Connect the Titan via a USB connection (directly or via the cradle) to the PC. Turn the Titan on by
pressing down either the R or L button on the handheld unit.
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 Titan appears
under Medical devices.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 24
Standalone installation of Titan Suite
If you do not want to run the Titan Suite through Noah or the OtoAccess® Database you can make a
shortcut on the desktop to directly launch the Titan Suite as a standalone module.
Go to Start | Programs | Interacoustics | Titan Suite. Right click on Titan Suite and select Send To | Desktop
(create shortcut). A shortcut for the Titan Suite 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 Titan product it already contains the license including the software modules you have
ordered. If you would like to add another module that is available in the Titan Suite, please contact your
dealer for a license.
1. Select Protocol | My Titan |Titan and change wireless connection to PC, by pressing the R or L
button.
2. From the task bar, left click on the Bluetooth Icon and select Add Device.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 25
3. When the screen below appears, select the Titan for pairing and then click Next. Enter the pairing
code (1234) and click Next.
4. The Titan and your PC are now connected via Bluetooth. Click Close.
To confirm the Bluetooth pairing, Start up the Titan Suite (see the Titan Additional Information
Manual for further instructions). Ensure that the Titan is still switched on.
5. After launching the Titan Suite go to MAIN | Menu | Setup | Enable wireless. The dialog box below
will appear and the software will search for wireless devices. When the Titan is found, a button will
appear indicating the serial number (which can be viewed from the Protocol | My Titan | Setup |
License… screen). Press the button to initialize the wireless connection.
With a proper wireless connection the wireless icon next to the Titan will indicate the strength of the
connection. If the Titan cannot be reached, check that the wireless connection is enabled on the
device and set for PC, it is within reasonable range of the PC.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 26
Now the Titan can be operated from PC in the same way as if it was connected via a USB cable.
Note: If the Titan will not connect correctly and your PC has its manufacturer’s Bluetooth Driver
installed, you may need to uninstall this and then try re-pairing the Titan with your PC.
1. Select Protocol | My Titan |Titan and change wireless connection to PC, by pressing the R or L
button.
2. From the task bar, right click on the Bluetooth Icon and select Add a Bluetooth Device.
3. When the screen below appears, select the Titan for pairing and then click Pair. Enter the pairing
code (1234) and click Next.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 27
4. The Titan is now wireless paired to your PC. Close the dialog box.
5. To confirm the pairing, Start up the Titan Suite (see the Titan Additional Information Manual for
further instructions). Ensure that the Titan is still switched on.
6. After launching the Titan Suite go to MAIN | Menu | Setup | Enable wireless. The dialog box below
will appear and the software will search for wireless devices. When the Titan is found, a button will
appear indicating the serial number (which can be viewed from the Protocol | My Titan | Setup |
License… screen). Press the button to initialize the wireless connection.
With a proper wireless connection the wireless icon next to the Titan will indicate the strength of the
connection. If the Titan cannot be reached, check that the wireless connection is enabled on the
device and set for PC, it is within reasonable range of the PC.
Note: If the Titan will not connect correctly and your PC has its manufacturer’s Bluetooth Driver
installed, you may need to uninstall this and then try re-pairing the Titan with your PC.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 28
3 Operating instructions
The instrument is switched on by pressing either the R or L button on the handheld unit. When operating the
instrument, please observe the following general precautions:
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 29
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 Titan 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 of 15°C /
59°F – 35°C / 95°F
4. The headphone and insert phone are calibrated to the shoulder box of this instrument – introducing
transducers from other equipment requires a re-calibration.
5. Never clean the transducer housing with water or insert non-specified instruments into the
transducer
6. Do not drop and avoid other undue impact to this device. If the instrument is dropped or otherwise
damaged, return it to the manufacturer for repair and/or calibration. Do not use the instrument if any
damage is suspected.
7. Although the instrument fulfils 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, caution must be taken to observe that no mutual disturbance appears.
When using the Titan probe and CIR55 contra phone, Sanibel 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 probe (and CIR55 contra phone) 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.
When performing a quick impedance screening test you may choose an umbrella shaped ear
tip. Umbrella ear tips seal the ear canal without the probe tip going into the ear canal. Press
the ear tip firmly into the ear canal in such a way that a seal remains during the complete test.
For more stable testing, we recommend using an extension cord with a mushroom shaped
ear tip. Make sure that this ear tip inserts completely into the ear canal. Mushroom shaped
ear tips allow you to test ‘hands free’ from the Titan. This reduces the chance of contact noise
disturbing the measurement.
Refer to the “Selecting the Correct Ear Tip” Quick Guide for an overview of ear tip sizes and selection.
To switch the Titan off, hold down both the and button at the same time for 1 second.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 30
NOTICE
The Titan takes approximately 2 seconds to boot up. Allow the unit to warm up for 1 minute before use.
Probe status
The probe status is indicated by the color of the light at the end of the extension cord, on the shoulder box or
on the probe status bar in the software. Below, the colors and their meanings are explained:
Color Status
Red Right ear is selected. Probe is out of the ear.
Blue Left ear is selected. Probe is out of the ear.
Green Probe is in the ear and a seal is maintained.
Yellow Probe is in the ear and is blocked, leaking or too noisy.
White The probe has just been attached. Probe status is unknown. If the probe light
stays white in any other situation the Titan may need to be switched off and
back on again to regain proper probe status.
Green changing The current test has been completed.
to red/blue
No light Titan is no longer monitoring the probe status, or the probe is in a big cavity
e.g when using Forced Start (for impedance and OAE).
Symbol Function
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 31
Operating Titan in handheld mode
3.5.1 Startup
The Titan will always start on the previously used protocol Test screen, ready to start a measurement.
When switching on the Titan in handheld mode after disconnecting from a PC, it will start in the Select
Protocol screen and you will have to select which protocol to use next.
3.5.2 Battery
When the Titan battery’s power capacity becomes low, the first indication you will see is the battery symbol in
the top right hand corner of the hand held unit change color. When the battery’s power level becomes too
low that measurements can no longer be performed, a warning will appear on screen, the measurement will
be stopped and all recorded data will be stored. You will have to turn off the handheld unit and change
battery or place the Titan in the cradle to be able to continue testing. Upon restarting the Titan, the previously
measured data will be recovered and you can continue with your measurements without retesting.
IMP440
The center of the screen is where the test measurement is displayed.
The normative box indicates the normative area where the peak of the
tympanogram is expected under normal conditions. The dimensions of the
normative box are defined in the protocol settings.
Vol = Volume
Press = Pressure
Comp = Compliance
Grad = Gradient
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 32
ABRIS440
The circles on the baby’s head indicate the electrode montage for the test
and the status of the electrode impedance; green = acceptable, amber =
poor.
Below the test time, the impedance value for each of the three electrodes
(white, red, blue) is displayed.
The three buttons on the bottom row of the screen correspond with the top
three function buttons on the hand held unit
During testing:
The EEG bar is displayed and shows the EEG peak values. The black bar
represents the EEG peak level above which a measurement will be rejected
(displayed in amber).
If the test is started when the electrode impedance indicators are amber
(poor), the impedance is not ideal warning window will appear. The user
must confirm whether they wish to proceed with testing if impedance values
are poor. Poor impedance can lead to longer test times and noisier
recordings.
DPOAE440
The center of the screen is where the test
measurement is displayed.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 33
TEOAE440
The center of the screen is where the test
measurement is displayed.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 34
Operating from this screen:
- Top left button will result in printing the test results of the left and right ears. Note that this will only
occur if a printer is wireless connected.
- Top middle button will bring you to the Select Client & Save Screen from where client data can be
saved. The Titan is made for intuitive use and after saving data Titan prepares itself for a new
measurement by clearing its working memory and returning to the Test screen. You can either
choose to print data before you save it or retrieve saved measurements from the session list and
print later
- Top right button displays a pop up a message asking, “Delete current or both ears?” when pressed.
The Top left button will cancel the process. The Top middle button will delete the data of the
currently selected ear and bring you back to the Test screen. The Top right button will delete data
on both ears and bring you back to the Test screen
- Right and Left buttons will respectively select the right or left ear for testing and will bring you back
to the Test screen. If data exists for the test ear, a pop-up will appear asking “Overwrite existing
data?”. The Top left and Top right buttons allow yes and no answers respectively
- Right and Left buttons will respectively select the right or left ear for testing and will bring you back
to the Test screen. Existing data from the chosen ear will only be deleted after pressing “Yes” to
“Overwrite existing data” (except IMP440). If the probe is detected to be in the ear with a proper seal
and the protocol has autostart enabled, a new measurement will automatically overwrite existing
data (IMP440 only)
- Up and Down buttons allow you to scroll through the different test results. When viewing the first or
last test of an ear, pressing Up or Down respectively will take you to the test results of the other ear.
- Shoulder box button will result in bringing you back to the Test screen
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 35
3.5.6 Edit New Screen
This screen allows you to input the client’s details before saving the measurement.
Operating from this screen:
- Top left button saves the client’s details and takes you back to the
Select Client & Save screen
- Top middle button will select the highlighted character and input it into
the selected field where the cursor appears. Backspace is found as an
arrow in the top right hand corner. Adding a space is achieved by
moving the course to the bar below the letters and hitting Select
- Top right button will tab to the next field available for editing
- Right and Left buttons allow you to move from left to right on the
keyboard panel
- Up and Down buttons allow you to move up and down on the keyboard
panel. When editing the birth date the Up and Down buttons will
change the numerical value
- Shoulder box button has no function while in this screen
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 36
3.5.9 Edit Details Screen
This screen shows the client ID, First Name, Last Name and Birth Date. On entering this screen, the First
name is selected for editing.
Operating from this screen:
- Top left button takes you back to the View Details screen
- Top middle button will select the highlighted character and input it
into the selected field where the cursor appears. Backspace is found
as an arrow in the top right hand corner. Adding a space is achieved
by moving the course to the bar below the letters and hitting Select
- Top right button will tab to the next field available for editing
- Right and Left buttons allow you to move from left to right on the
keyboard panel
- Up and Down buttons allow you to move up and down on the
keyboard panel. When editing the birth date the Up and Down
buttons will change the numerical value
- Shoulder box button has no function while in this screen
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 37
Operating from this screen:
- Top left takes you back to the View Sessions screen
- Top middle button will print all. Note that this will only occur if a printer is wireless connected to the
Titan.
- Top right button has no function
- Right and Left buttons will toggle between the saved recordings for the right or left ear respectively,
if available
- Up and Down buttons allow you to scroll through the different tests that are saved in the selected
session
- Shoulder box button has no function
Note: If forced saving has been enabled on the hand held unit,
this screen is not available.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 38
3.5.14 Language Screen
Use the Right and Left buttons to adjust the language. Available
languages are English, German, Spanish, French, Italian, Portuguese,
Czech, Russian, Japanese, Chinese and Korean.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 39
Use the Top right button to search for a wireless connection to a
printer. When more than one printer is found, use the Up and Down
buttons to select the printer of your choice. Press the Top right button
to select the printer.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 40
3.5.20 About Screen
Here you will find information about the Titan’s firmware version and
calibration dates.
Pressing the Up and Down buttons simultaneously will give you the
MCU and DSP compile dates.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 41
Daily system checks for OAE devices
It is recommended to perform a daily check of your OAE equipment to ensure that it is in good working order,
before testing on patients. Running a probe integrity test and a real-ear check allows for any probe faults or
system distortions that can masquerade as biological responses to be detected. A daily check ensures that
you can be certain that the results obtained throughout the day are valid.
Test procedure:
1. Insert the probe into the provided test cavity or ear simulator. It’s important to use the correct-sized
cavity for valid test results.
2. Select an OAE test protocol directly from the device or using the Titan Suite. As system distortion is
dependent on stimulus output level, select a protocol that reflects what is used most often in clinical
practice.
3. Start the test and allow it to run until the test stops automatically. Do not stop the test manually.
Test results:
If the probe is functioning correctly, none of the frequency bands (TEOAE) or points (DPOAE) should have a
checkmark, i.e., no artifacts/OAEs should be detected above the noise floor.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 42
No system distortion System distortion present
If an error message appears during testing or if one or more of the OAE bands or points has a checkmark
(meaning detected), the probe integrity test has failed. This could indicate that:
1. There is wax or debris in the probe tip and cleaning is required.
2. The probe was not placed in the test cavity or ear simulator correctly, or,
3. The probe’s calibration needs to be checked.
4. The test environment may be too noisy for testing. Find a quieter location for testing.
Check and clean the probe tip and retry the test. If the probe test fails a second time, the probe should not
be used to test on patients. Contact your local service technician for assistance.
If results from the real-ear test do not match the expected result after checking items 1 to 5 above, the probe
should not be used to test on patients. Contact your local service technician for assistance.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 43
Operating in PC controlled mode
NOTICE
Allowing the PC to go into sleep mode or hibernation may cause the Suite 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.
For further instructions about working with the database, please see the operation manual for Noah.
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.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 44
Wireless PC controlled operation
PC operated measurements can be made while connecting wirelessly (no USB cable required). Ensure that
your PC allows for a wireless connection and that it is switched on.
Check that your Titan is setup to use its wireless connection to a PC (and not to a printer). This is done by
switching on the handheld unit and pressing Protocol | My Titan | Titan… Item Wireless connection
should be set to “PC”.
After starting the Titan Suite go to Main | Menu | Setup | Enable wireless. The dialog box below will appear
and the software will search for wireless devices. When the Titan is found, a button will appear indicating the
serial number (which can be viewed from the Protocol | My Titan | Setup | License… screen). Press the
button to initialize the wireless connection.
With a proper wireless connection the wireless icon next to the Titan will indicate the strength of the
connection. If the Titan cannot be reached, check that the wireless connection is enabled on the device and
set for PC, it is within reasonable range of the PC.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 45
Using the main tab
The following section describes the elements of the Main tab:
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 46
• Menu | Setup | Enable wireless will activate automatic wireless search for
a Titan nearby ready for pairing, when no Titan is connected via USB.
• Menu | Setup | Enable quick transfer enables the Quick Transfer function
which will be accessible through the main screen. See further description of
the Quick Transfer function below in this section.
• Menu | Setup | Reset standalone database deletes all sessions in the
standalone database upon confirmation through the dialog box as shown
below.
Main returns you to the main screen from the Client upload or Session download
screen.
Names and other details of patients who are expected for an assessment can be
stored on the hardware prior to testing. Patient data can be uploaded from either
the OtoAccess® Database or Noah.
The OtoAccess® Database allows multiple patient transfer. The Noah database
allows transfer of one patient to the hardware at a time.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 47
4. After selecting one or more patients, press Add to add the names to the
Clients on device.
5. If you want to change the order in which the patients appear on the device,
select a patient in the Client on device list and use the up and down arrows
to move them in the list.
6. Press Save to hardware to store the patient data on the device.
7. To remove a patient from the device, highlight it in the Clients on device list
and click on Remove.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 48
Session download allows saved patient data to be transferred and stored in the
OtoAccess® Database or Noah database
In the instance where you have patients (e.g, ID 1) stored on the handheld unit that
are not linked to patients in the OtoAccess® Database, the Client not known in
database window will pop up (see figure below). Here you are prompted to link
sessions to patients in the OtoAccess® Database. Continue the downloading
process in the Client not known in database window as described below. For
each Unknown client the generic name (A) and the sessions (B) stored for that
patient are listed on the screen.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 49
1. From the Select client target in database list you can select the patient to
which you want to store these sessions.
2. If your patient is not in the list you can search in the OtoAccess® Database
by selecting the Field you wish to search in and typing a query in the
Search field.
3. Once the correct patient is selected, press Save to store the session in the
OtoAccess® Database.
4. If the patient details are not yet stored in the OtoAccess® Database, press
the Enter new patient button to create a new patient in the OtoAccess®
Database. When the New client data window pops up, enter the relevant
patient details and press OK to save the session to this new patient or
press Cancel to abort.
5. The process will now continue for the remaining sessions you have
selected to copy to the OtoAccess® Database. After the last session is
stored, the window will close.
6. Pressing the Skip this Client button skips the patient and sessions shown
on screen and progresses to the next patient selected from the Copy to PC
list. Sessions for the skipped patient are not saved to the OtoAccess®
Database, but will remain on the device.
After the download process is finished, a confirmation pop up will appear to indicate
that the procedure was successful. Press OK to close the confirmation window.
The Status of download column will now be updated to show which sessions were
downloaded. In the Copy to PC column, the checkboxes for the downloaded
sessions will now be grayed out to avoid downloading them twice to the database.
When the Titan is disconnected from your PC the download screen will be reset.
1. Open Noah. Make sure the Titan is connected and switched on.
2. Search for and select the patient from the Client Register screen who you
want to download the saved session to from the handheld unit. The screen
will change to show the saved sessions of the selected patient.
3. Open the Module Selection dialog box, go to the Measurement tab and
double click on the Titan Suite icon.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 50
4. Press the Session Download icon on the Main tab.
5. A list of stored sessions will automatically be shown. Underneath the Copy
to PC header, select which sessions you would like to copy to the Noah
client you are working with.
6. Press Download.
Repeat the above process for all sessions to be transferred from the device to the
Noah database.
Quick Transfer allows for the fast and easy transfer of the last saved patient data
from the Handheld Unit to either the standalone Titan software or to the currently
selected OtoAccess® Database or Noah patient file.
Following transfer, the data recorded on the handheld unit will be available for
review and printing from the historic session dropdown list in the respective module
tabs.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 51
Using the IMP module
The following operations are available on the Imp tab of Titan Suite.
Print allows for printing the onscreen results directly to your 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).
Print to PDF icon appears when setup via the General 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).
Save & New Session saves the current session in Noah or the
OtoAccess® Database (or to a commonly used XML file when running
in standalone mode) and opens a new session.
Save & Exit saves the current session in Noah or the OtoAccess®
Database (or to a commonly used XML file when running in standalone
mode) and exits the Suite.
Toggle Ear changes from right to left ear and vice versa in all modules.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 52
List of Defined Protocols allows for selecting a test protocol for the
current test session (refer to the Additional Information document for
more details about protocols).
Report editor button opens a separate window for adding and saving
notes to the current or historic session.
List of age groups will show when the protocol contains a wide band
tympanometry test. The selection in this list will by default match the
known age of the patient. Changing the age will impact which normative
data is displayed in absorbance graphs. Also, the calibration values of
wide band tympanometry tests depend on the age selection. Below and
above the age of six months the used calibration values change. Thus
make sure to have the correct age selected before the measurement
starts.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 53
Show sketched absorbance examples allow to view examples of how
normal as well as pathologic absorbance curves could appear on
screen.
The protocol listing shows all tests that are part of the selected
protocol. The test that is displayed in the test screen area is highlighted
blue or red, depending on the chosen ear.
If more tests than can fit in the window are included in the protocol, a
scrollbar will be visible.
A checkmark in the box indicates that the test will run when 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 START.
A white checkmark indicates that (at least some) data for this test is
stored in the memory.
START and STOP button are used for starting and stopping the
session.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 54
The following operations are available in manual mode.
In the tymp test:
Press the Record button to start recording the tympanogram.
Press the Stop button to stop the recording of the tympanogram.
Press the Release Pressure button to have the pressure released
and brought back to 0 daPa.
This Start (and Stop) button is used to start and stop the manual
pressure changing. When stopped, Titan will try to keep the
pressure constant.
With the duration slider you can set the stimulus length to 10, 15,
20, 25 or 30 seconds during manual reflex decay testing.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 55
Using the 3D Tympanometry and Absorbance test
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 56
Activating Draw pressure line (tymp) highlights a tympanogram in
the 3D graph at the frequency selected with the slider.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 57
The following numerical information is displayed:
- The equivalent ear canal volume
- The lowest available resonance frequency at peak pressure.
The tympanogram found at this resonance frequency can be
interesting for differentiating between some pathologies (for
example to distinguish between a flaccid eardrum and a
discontinuity of the ossicular chain)
- Peak pressure as found in the frequency averaged
tympanogram
- The peak compliance for both tympanograms at 226 Hz (in ml)
and 1000 Hz (in mmho)
The Wide Band Tympanogram is the average curve in a range of the measurement. For babies under the
age of 6 months the curves from 800 to 2000 Hz are averaged. For older children and adults the average is
taken from 375 to 2000 Hz. It has been shown that WB tympanograms perform better than 1000 Hz
tympanograms in explaining why an OAE screening has resulted in a refer, particularly in infants.
The WB tympanogram is influenced less by noise and offers more reliable information than the traditional
frequencies of 1000 Hz in infants and 226 Hz for older children and adults. Sanford et al. 4 recommend
considering the implementation of the WB tympanogram in the follow up diagnostics of neonatal screening
programs.
The Selected Frequency allows you to view the tympanogram of each frequency from 200-4000 Hz in a 50
Hz step resolution. This function is license dependent.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 58
Using the right mouse click in the tympanogram window gives a
pop up window. The following options are available:
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 59
The table with measurement values. Here you will find
- V or Volume, the equivalent ear canal volume
- C or Compliance, the peak compensated static acoustic
admittance, or in other words: When the tympanogram is shown
baseline compensated, C is the compliance value at the peak. A
peak compliance (or peak absorbance) for the averaged
tympanogram is not calculated
- P or Pressure, the pressure at which the peak (or highest
compliance) is detected
- G or Gradient. If it is chosen to show gradient in pressure values,
it gives the tympanogram width at half the height of the peak
compensated static acoustic admittance. If it is chosen to show
gradient as a compliance value it gives the average of the two
compensated admittance values which are 50 daPa away from
the peak pressure. Gradient is not calculated for averaged tymps
Note that the view of the table changes when activating Peak
difference.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 60
The Absorbance difference from norm provides a view of how
the absorbance curve differentiates from the 50% percentile. This
provides as a tool to see if there is a significant deviation from the
norm. If that is the case the peak height and peak size will appears
as values below the graph.
The calculation is based on the study by Merchant et al. 2015 5. For
a more detailed description of the use of the calculation please
refer to the quick guide. This function is license dependent.
5Merchant et. al. (2015). Power Reflectance as a Screening Tool for the Diagnosis of Superior Semicircular
Canal Dehiscence. Otology & Neurotology.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 61
Using the ABRIS module
The following section describes the elements of the ABRIS screen.
Print to PDF icon appears when setup via the General Setup.
This allows for printing directly to a PDF document that is saved
to the PC. (Refer to the Additional Information for setup
information).
Save & New Session saves the current session in Noah or the
OtoAccess® Database (or to a commonly used XML file when
running in standalone mode) and opens a new session.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 62
Save & Exit saves the current session in Noah or the
OtoAccess® Database (or to a commonly used XML file when
running in standalone mode) and exits the Suite.
Toggle Ear changes from right to left ear and vice versa in all
modules. When the transducer setup allows it (with headphones
or inserts) you can also toggle to binaural.
Before testing, the Timer symbol indicates after how much time
the ABRIS 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.
START (and STOP) button are used for starting and stopping the
session.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 63
Patient noise displays the EEG peak values.
Displays the EEG rejection level and the arrow buttons allow
modification of the rejection level
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 64
Impedance is not ideal warning window will appear if any of the
electrode impedance indicators are amber in color. The user
needs to confirm whether they wish to proceed with testing if
impedance values are poor.
When enabled in the software, the Residual Noise value and the
Residual Noise Stopping Criteria will be displayed.
The Residual Noise value will update during the test as the
measurement is progressing.
If the Residual Noise value reaches the Stop testing at (nV)
value before a Pass has been detected, the test will stop
automatically, and the result displayed will be a Refer.
EEG too high indicates that the EEG peak level causes rejection
of the measurement.
Mains noise detected Mains noise detected indicates that mains interference is
detected by the algorithm. All measurements are rejected while
this message is displayed on screen.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 65
Connect transducer means that there is no transducer
connected the preamplifier.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 66
Using the DPOAE module
The following section describes the elements of the DPOAE screen.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 67
Toggle Ear changes from right to left ear and vice versa in
all modules.
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.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 68
Report editor button opens a separate window for adding
and saving notes to the current or historic session.
The protocol listing shows all tests that are part of the
selected protocol. The test that is displayed in the test screen
area is highlighted blue or red, depending on the chosen ear.
A checkmark in the box indicates that the test will run when
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 START.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 69
START (and STOP) button are used for starting and
stopping the session.
During testing, the probe check is not running and the graph
will not display a curve.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 70
The DP found checkmark symbol, a black checkmark in a
green circle, indicates that this individual measurement met
its specified criterion and no further testing at this frequency
will occur.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 71
Measure only selected frequency results in re-testing the
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.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 72
The Point Summary table displays the f2 test frequencies,
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.
When the stimulus level goes outside the tolerance set in the
protocol setup, the stimuli levels outside tolerance pop-up
dialogue will appear on screen.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 73
Using the TEOAE tab
The following section describes the elements of the TEOAE screen.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 74
Toggle Ear changes from right to left ear and vice versa in
all modules.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 75
The Acceptable noise level slider allows setting the
acceptable 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 protocol listing shows all tests that are part of the
selected protocol. The test that is displayed in the test
screen area is highlighted blue or red, depending on the
chosen ear.
A checkmark in the box indicates that the test will run when
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 START.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 76
The stimulus graph displays the click stimulus being
presented to the ear as a function of magnitude (Pa) over
time (ms). The scroll wheel of your mouse allows for
zooming in and out with respect to the magnitude (y) axis.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 77
Pointing at the desired graph and then using the scroll
wheel of your mouse allows zooming in and out on all
graphs.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 78
The minimum test requirements as defined 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.
When the stimulus level goes outside the tolerance set in the
protocol setup, the stimulus levels outside tolerance pop-
up dialogue will appear on screen.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 79
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 Titan Suite tabs (IMP, DPOAE, TEOAE or ABRIS)
b. If you want to make a template or select an existing one to link to a specific protocol: Go to Module
tab (IMP, DPOAE, TEOAE or ABRIS) 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 2 6
3 4
11 12a 13
12b
1. Underneath 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 IMP440,
ABRIS440, DPOAE440 or TEOAE440 window is recognized by a checkmark.
6. Press the New Template button to open a new empty template.
7. Select one of the existing templates and press the Edit Template button to modify the selected
layout.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 80
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 Titan Additional Information document.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 81
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 82
4 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 repairer 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. For TEOAE, a daily probe test is recommended to confirm the probe is
functioning properly before testing on patients.
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 mains power
adaptor and battery 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. If ear cushions or are contaminated, it is strongly recommended to
remove them from the transducer before they are cleaned. Water should be used for frequent
cleaning, but in the case of severe contamination it may be necessary to use a disinfectant.
• Before cleaning always switch off and disconnect from the power supply
• Use a soft cloth lightly dampened with cleaning solution to clean all exposed surfaces
• Do not allow liquid to come in contact with the metal parts inside the earphones / headphones
• 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 screens on the instruments
• Ensure that isopropyl alcohol does not come into contact with any silicone tubes or rubber parts
Procedure
• Clean the instrument by wiping outer case with a lint free cloth lightly dampened in cleaning solution
• Clean cushions and patient hand switch and other parts with a lint free cloth lightly dampened in
cleaning solution
• Make sure not to get moisture in the speaker portion of the earphones and similar parts
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 83
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.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 84
Notice:
Do not use the cleaning tool to clean the probe base. This will destroy the filters.
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 and
sends it to DGS Diagnostics Sp. z o.o., ul. Sloneczny Sad 4d, 72-002 Doluje, Polska.
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 Titan 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 centre 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
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 85
• 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.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 86
5 General technical specification
Titan hardware – technical specifications
Medical CE-mark The CE-mark indicates that Interacoustics A/S meets the requirements of Annex II of the Medical
Device Directive 93/42/EEC.
Approval of the quality system is made by TÜV – identification no0123
Standards Safety: IEC 60601-1: 2005, Internally powered, Type B and BF applied parts
EMC: IEC 60601-1-2: 2014
Impedance: IEC 60645-5:2004 /ANSI S3.39, Type 1
Test Signal: IEC 60645-1:2012 /ANSI S3.6 , IEC 60645-3: 2007
OAE: IEC 60645-6:2009, TEOAE Type 1 & 2 Otoacoustic emissions
IEC 60645-6:2009, DPOAE Type 2 Otoacoustic emissions
ABR: IEC 60645-7: 2009, Type 2
FIPS: Complaint in accordance with FIPS PUB 140-2
Cradle Safety: IEC 60601-1:2014, Class II
Power Astrodyne ASA30M-0301 or UE24WCP
Mains voltages and 100 – 240 VAC, 47 – 63 Hz
frequencies:
Consumption: 0.8 – 0.4 A
Battery Use only: NP120 or CGA103450
Operation environment Temperature: 15 – 35 °C
Relative Humidity: 30 – 90%
Ambient Pressure: 98kPa – 104kPa
Warm-up Time: 1 minute
Transport & Storage Storage Temperature: 0°C – 50°C
Transport Temperature: -20 – 50 °C
Rel. Humidity: 10 – 95%
Impedance measuring system
Probe tone Frequency: Classic tympanometry: 226 Hz, 678 Hz, 800 Hz, 1000 Hz; pure
tones; AGC controlled to protect for loud probe tone stimuli in small
ear canals.
WBT: 226 Hz – 8000 Hz broadband stimulus, 21.5/sec.
Level: 226 Hz: 85 dB SPL (≈ 69 dB HL)
WBT: 96 dB peSPL (infant) / 100 dB peSPL (adult). (100 dB peSPL
≈ 65 dB nHL)
Air pressure Control: Automatic.
Indicator: Measured value is displayed on the graphical display.
Range: -600 to +300 daPa.
Pressure limitation: -750 daPa and +550 daPa.
Pressure change rate: Minimum, medium, maximum or automatic with minimum speed at
compliance peak. Selectable in the setup.
Compliance Range: 0.1 to 8.0 ml at 226 Hz probe tone (Ear volume: 0.1 to 8.0 ml) and 0.1
to 15 mmho at 678, 800 and 1000 Hz probe tone.
Test types Tympanometry Automatic, where the start and stop pressure can be user-
programmed in the setup function.
Manual control of all functions.
Eustachian tube function 1 – Williams test
Non perforated eardrum
Eustachian tube function 2 – Toynbee test
Perforated eardrum
Eustachian tube function 3 – Continuous sensitive impedance measurement for 30 up to 150 s.
Patulous Eustachian tube
Indicators Graphical display Compliance is indicated as ml and pressure as daPa. In PC
controlled mode admittance, susceptance and conductance can be
printed.
Stimulus level is indicated as dB Hearing Level.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 87
Memory Tympanometry: 1 curve per ear per tympanometry test. 3 curves per ear per
Eustachian tube function test. And theoretically an infinite number of
tests per protocol.
There is no deviation between static and dynamic mode.
Reflex functions
Signal sources Tone - Contra, Reflex: 250, 500, 1000, 2000, 3000, 4000, 6000, 8000 Hz.
Tone - Ipsi, Reflex: 500, 1000, 2000, 3000, 4000 Hz.
NB noise - Contra, Reflex: 250, 500, 1000, 2000, 3000, 4000, 6000, 8000 Hz.
NB noise - Ipsi, Reflex: 1000, 2000, 3000, 4000 Hz.
Noise - Contra, Reflex: Wide Band, High Pass, Low Pass.
Noise - Ipsi, Reflex: Wide Band, High Pass, Low Pass.
Stimulus duration: 750 ms (continuous), 1500 ms (pulsed)
Outputs Contra Earphone: TDH39 earphone, DD45 earphone, CIR55 insert and/or E-A-RTONE
3A/IP30 insert for Reflex measurements.
Ipsi Earphone: Probe earphone incorporated in the probe system for Reflex
measurements.
Air: Connection of the air system to the probe.
Test types Manual Reflex Manual control of all functions.
Automated Reflex Automatic reflexes:
- Single intensities
- Reflex growth
Reflex Decay Automatic, 10 dB above threshold and manually controlled with
stimulus durations of 10 to 30 s.
Reflex latency Automated, first 300 ms from stimulus start.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 88
DPOAE
Stimulus Frequency range: 500 to 10000 Hz
Nominal frequency: f2
Frequency step: 1 Hz
Level: 30 to 80 dB SPL (75 dB SPL for 6kHz and 65 dB SPL for 8kHz to
10kHz)
Level Step: 1 dB
Transducer:
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
Averaging method: Bayesian weighted averaging
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), noise rejection level, tympanic peak
pressure
Basic or advanced view of the DP-Gram, test summary table, point
summary table
Probe specifications Titan IOWA probe: Clinical extension cable with fixed IOWA probe. Auto detection and
auto calibrated. IMP, DPOAE and TEOAE capable
Replaceable probe tip
Test Pressure Ambient pressure
Tympanic peak pressure (from IMP module)
The Titan with DPOAE440 uses an improved method of stimuli level control, which more accurately delivers the specified intensity in the
full range of ear canals, from infants to adults. The applicability of the IEC 60645-6 standard is currently limited to adult ears. Therefore,
in order to better serve a market with a product that provides more accurate stimulus levels to a wide range of ear canal volumes
(specifically infants), we have elected to utilize a more comprehensive calibration procedure for DPOAEs that is outside the scope of
IEC 60645-6 for some protocols.
This improved method of stimulus control is enabled when the “Use Microphone compensation” checkbox is checked. To use the
IEC60645-6 calibration method, uncheck the “ Use Microphone compensation” in the Advanced tab of the protocol setup.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 89
TEOAE
Stimulus Frequency range: 500 to 5500 Hz
Frequency step: 1 Hz (Custom bands)
Stimulus type: Non-Linear and 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 Hz 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
Time recording window: 4 – 23 msec (max). A and B buffer time-samples @ sampling rate
11025 Hz
Freq. response window: 256 points frequency response, bin spacing 43 Hz
Averaging method: Bayesian weighted averaging
Residual noise: A RMS value for each octave band, based on the Bayesian weighted
average for the defined OAE time window
Display Other information: In ear status (active before during & after test), noise rejection level,
tympanic peak pressure
Basic or advanced view, FFT view, test summary table. band
summary table
Probe specifications Titan IOWA probe: Clinical extension cable with fixed IOWA probe. Auto detection and
auto calibrated. IMP, DPOAE and TEOAE capable.
Replaceable probe tip
Test Pressure Ambient pressure
Tympanic peak pressure (from IMP module)
General
PC control USB: Titan can be fully operated from a PC via a USB connection.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 90
Long extension cable 66 g / 0.14lbs
shoulder box weight
Long extension cable 9.5 x 4.5 x 2.2 cm / 3.7 x 1.8 x 0.8 inches
shoulder box dimensions
Long extension cable 234 cm / 92 inches
length
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 91
Table 1: Frequencies and intensity ranges for IMP440
Titan Maximums IMP
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 92
Specification of input/output connections
Outputs
Phones, Left/ Right Jack, 3,5mm Voltage: Up to 3V rms. by 10Ω load
4-pole Min. load impedance: 8Ω Pin 3:
Pin 1: CH1 GND
Pin 2: CH1 OUT (left)
Pin 3: CH2 OUT (right)
Pin 4: CH1 GND
Phones, Jack, 3,5mm Voltage: Up to 3V rms. by 10Ω load
Contralateral 4-pole Min. load impedance: 8Ω
Pin 1: CH1 GND
Pin 2: CH1 OUT (left)
Pin 3: CH2 OUT (right)
Pin 4: CH1 GND
Transducer IA proprietary, Pin 1: CH1 out
12-pole Pin 2: CH1 GND
Pin 3: DGND
Pin 4: GND A / GND Microphone
Pin 5: Microphone – input / Analog balanced in
Pin 6: Microphone + input / Analog balanced in
Pin 7: Power supply +3/+5V
Pin 8: CH2 out
Pin 9: CH2 GND
Pin 10: I2C CLK
Pin 11: I2C DATA
Pin 12: I2C Interrupt
Data I/O
USB USB type”B” USB port for communication
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 93
Calibration properties
Calibrated Contralateral Earphone:
TDH39 or DD45 with a static force of 4.5N ±0.5N
Transducers and/or E-A-RTONE 3A/IP30 and/or CIR55 insert
phone
Probe system: Ipsilateral Earphone: is integrated in the probe system
Probe frequency transmitter and receiver and
pressure transducer is integrated in the probe system
Accuracy General: Generally the instrument is made and calibrated to be
within and better than the tolerances required in the
specified standards:
Reflex Frequencies: ±1%
Contralateral Reflex and ±3 dB for 250 to 4000Hz and ±5 dB for 6000 to
Audiometer Tone Levels: 8000Hz
Ipsilateral Reflex Tone ±5 dB for 500 to 2000Hz and +5/-10 dB for 3000 to
Levels: 4000Hz
DPOAE Levels: ±1.5 dB for 1000 to 4000Hz and ±3 dB outside range
TEOAE Levels: ±2 dB for click stimulus
ABRIS Levels: ±2 dB for all stimulus types
Pressure measurement : ±5% or ±10 daPa, whichever is greater
Compliance measurement: ±5% or ±0.1 ml, whichever is greater
Stimulus Presentation Reflexes: ON-OFF ratio = ≥ 70 dB
Control Rise time = 27 ms
Fall time = 24.6 ms
A weighted SPL in Off = 31 dB
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 94
Reflex calibration standards and spectral properties:
General Specifications for stimulus and audiometer signals are made to follow IEC 60645-5
Contralateral Pure tone: ISO 389-1 for TDH39/DD45 and ISO 389-2 for
Earphone CIR 55.
Wide Band noise (WB): Interacoustics Standard
− Spectral properties: As “Broad band noise” specified in IEC 60645-5, but
with 500 Hz as lower cut-off frequency.
Low Pass noise (LP): Interacoustics Standard
− Spectral properties: Uniform from 500 Hz to 1600 Hz, ±5 dB re. 1000 Hz
level
High Pass noise (HP): Interacoustics Standard
− Spectral properties: Uniform from 1600 Hz to 10KHz, ±5 dB re. 1000 Hz
level
Ipsilateral Earphone Pure tone: Interacoustics Standard.
Wide Band noise (WB): Interacoustics Standard
− Spectral properties: As “Broad band noise” specified in IEC 60645-5, but
with 500 Hz as lower cut-off frequency.
Low Pass noise (LP): Interacoustics Standard
− Spectral properties: Uniform from 500 Hz to 1600 Hz, ±10 dB re. 1000 Hz
level
High Pass noise (HP): Interacoustics Standard
− Spectral properties: Uniform from 1600 Hz to 4000 Hz, ±10 dB re. 1000
Hz level
General about levels: The actual sound pressure level at the eardrum will
depend on the volume of the ear. See Table 2 for
details.
The risk of artifacts at higher stimulus levels in reflex measurements are minor and will not activate the
reflex detection system
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 95
Table 3: Reference values for stimulus calibration (impedance)
Freq. Reference values for stimulus calibration Variation of Sound
Ipsi stimulus attenuation
[dB re. 20 µPa] levels for values for
different TDH39
volumes of the earphones
ear canal using
Relative to the MX41/AR or
calibration PN51
performed on cushion
an IEC 126 [dB]
coupler
[dB]
0.5 ml 1 ml
(Interacoustics
(Interacoustics
(Interacoustics
Interacoustics
Interacoustics
Interacoustics
(ISO 8798)
Standard)
Standard)
Standard)
ISO 389-1
ISO 389-2
ISO 382-2
ISO 389-4
Standard
Standard
Standard
ISO389-1
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 96
Table 4: Reference values for stimulus calibration (ABR)
Stimulus Reference values for stimulus calibration
[dB re. 20 µPa]
Interacoustics Standard Values
TDH39 E-A-RTONE DD45 E-A-RTONE IOW Probe
ABR /IP30 ABR /IP30
inserts EarCups
CE-Chirp 27.5 31.5 26 58.5 32
CE- Chirp 26.5 26.5 25.5 50 27.5
peRETSPL
Low
CE- Chirp 28 31 28 58 32
High
Click 30.5 35 32.5 61.5 33.5
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 97
Coupler types used for calibration
IMP:
TDH39 is calibrated using a 6cc acoustic coupler made in accordance to IEC 60318-3, Ipsilateral earphone
and probe tone are calibrated using a 2cc acoustic coupler made in accordance to IEC 60318-5
ABRIS:
Probe and insert stimuli are calibrated in SPL values using an ear simulator coupler made in accordance to
IEC 60318-4. Headphones (TDH39 and DD45) stimuli are calibrated in SPL values using an artificial ear
coupler according to IEC 60318-1.
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.
Interacoustics puts diagrams and service manuals at the disposal of authorized service companies.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 98
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.
Portable and mobile RF communications equipment can affect the TITAN . Install and operate the TITAN according to the EMC information
presented in this chapter.
The TITAN has been tested for EMC emissions and immunity as a standalone TITAN . Do not use the TITAN 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.
Recommended separation distances between portable and mobile RF communications equipment and the TITAN .
The TITAN is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user
of the TITAN can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the TITAN as recommended below, according to the maximum output power of the
communications equipment.
Rated Maximum output Separation distance according to frequency of transmitter
power of transmitter [m]
[W] 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d = 1.17√𝑃𝑃 d = 1.17√𝑃𝑃 d = 2.23√𝑃𝑃
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 99
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The TITAN is intended for use in the electromagnetic environment specified below. The customer or the user of the TITAN should assure
that it is used in such an environment.
Immunity Test IEC 60601 Test Compliance Electromagnetic
level Environment-Guidance
Electrostatic Discharge +6 kV contact +6 kV contact Floors should be wood, concrete or
(ESD) ceramic tile. If floors are covered with
+8 kV air +8 kV air synthetic material, the relative humidity
IEC 61000-4-2 should be greater than 30%.
Electrical fast +2 kV for power supply lines +2 kV for power supply lines Mains power quality should be that of a
transient/burst typical commercial or residential
+1 kV for input/output lines +1 kV for input/output lines environment.
IEC61000-4-4
Surge +1 kV differential mode +1 kV differential mode Mains power quality should be that of a
typical commercial or residential
IEC 61000-4-5 +2 kV common mode +2 kV common mode environment.
Voltage dips, short < 5% UT < 5% UT (>95% dip in UT) Mains power quality should be that of a
interruptions and voltage (>95% dip in UT) for 0.5 cycle for 0.5 cycle typical commercial or residential
variations on power supply environment. If the user of the TITAN
lines 40% UT 40% UT (60% dip in UT) for requires continued operation during
(60% dip in UT) for 5 cycles 5 cycles power mains interruptions, it is
IEC 61000-4-11 recommended that the TITAN be
70% UT 70% UT (30% dip in UT) for powered from an uninterruptable power
(30% dip in UT) for 25 cycles 25 cycles supply or its battery.
<5% UT <5% UT
(>95% dip in UT) for 5 sec
Power frequency (50/60 3 A/m 3 A/m Power frequency magnetic fields should
Hz) be at levels characteristic of a typical
location in a typical commercial or
IEC 61000-4-8 residential environment.
Note: UT is the A.C. mains voltage prior to application of the test level.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 100
NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects and people.
(a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,
AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment
due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the
TITAN is used exceeds the applicable RF compliance level above, the TITAN should be observed to verify normal operation, If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating the TITAN .
(b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 101
To ensure compliance with the EMC requirements as specified in IEC 60601-1-2, it is essential to use
only the following accessories:
ITEM MANUFACTURER MODEL
Clinical Probe Extension Interacoustics -
Short Probe Extension Interacoustics -
ABRIS Preamplifier Interacoustics -
CIR55 Insert Phone Interacoustics CIR55
TDH39C Contra Headset Interacoustics TDH39C
DD45C Contra Headset Interacoustics DD45C
E-A-RTONE 3A with Minijack Interacoustics Ear3A
CIR55 Contra ID Earphone Interacoustics CIR55
IP30 contra with minijack Interacoustics IP30
TDH39C Contra ID Headset Interacoustics TDH39C
DD45C Contra ID Headset Interacoustics DD45C
E-A-RTONE 3A Contra ID Earphone Interacoustics Ear3A
TDH39 Stereo ID headset Interacoustics TDH39
DD45 Stereo ID headset Interacoustics TDH39
IP30 contra ID earphone Interacoustics IP30
E-A-RTONE ABR Stereo ID Headset Interacoustics Ear3A
EarCup Stereo ID Headset Interacoustics Ear3A
IP30 Earcup stereo ID headset Interacoustics IP30
IP30 ABR stereo ID earphone Interacoustics IP30
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:
Description Length Screened?
Mains Cable 2.0m Unscreened
USB Cable 2.0m Screened
PSU USB Adapter 0.1m Screened
Clinical Extension Cable 2.4m Unscreened
Short Extension Cable 0.4m Unscreened
ABRIS Preamplifier 2.0m Unscreened
CIR55 Insert Phone 0.4m Screened
TDH39C Contra Headset 0.5m Screened
DD45C Contra Headset 0.5m Screened
E-A-RTONE 3A with Minijack 0.5m Screened
IP30 contra with minijack 0.5m Screened
CIR55 Contra ID Earphone 0.4m Screened
TDH39C Contra ID Headset 0.5m Screened
DD45C Contra ID Headset 0.5m Screened
E-A-RTONE 3A Contra ID Earphone 0.5m Screened
IP30 contra ID earphone 0.5m Screened
TDH39 Stereo ID headset 0.5m Screened
DD45 Stereo ID headset 0.5m Screened
E-A-RTONE ABR Stereo ID Headset 0.5m Screened
E-A-RTONE EarCup Stereo ID 0.5m Screened
Headset
IP30 EarCup stereo ID headset 0.5m Screened
IP30 ABR stereo ID earphone 0.5m Screened
D-0100608-I – 2019/11
Titan - Instructions for Use - EN Page 102
Return Report – Form 001
Opr. dato: af: Rev. dato: 2015-04-15 af: Rev. nr.:
2014-03-07 EC MSt 4
Address
Company:
DGS Diagnostics Sp. z o.o.
ul. Sloneczny Sad 4d
Address: 72-002 Doluje
Polska
Phone:
Fax or e-mail:
Included parts:
Date : Person :
Please provide e-mail address or fax No. to whom Interacoustics may
confirm reception of the returned goods:
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)
1
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 1