Interacoustics Titan IMP440 Operating and safety instructions

Titan – Setup
& Installation
80655241 ver. 06/2011

Table of contents
1Introduction ............................................................................................................................... 1
1.1Intended Use ...................................................................................................................... 1
1.1.1Typical Applications........................................................................................................ 1
1.2Safety Notes ....................................................................................................................... 2
1.3Warranty ............................................................................................................................. 4
1.4General Maintenance Procedures...................................................................................... 5
1.5Unpacking and Inspection .................................................................................................. 5
1.6Reporting Damage ............................................................................................................. 6
1.7Concerning Maintenance and Repair................................................................................. 6
2System Setup ............................................................................................................................ 7
2.1System Requirements ........................................................................................................ 7
2.1.1PC minimum Requirements ........................................................................................... 7
2.1.2Supported Operating Systems ....................................................................................... 7
2.1.3Supported Noah3 Office Systems.................................................................................. 7
2.2System Installation ............................................................................................................. 8
2.2.1Hardware Installation...................................................................................................... 8
2.2.1.1Installing the Cradle................................................................................................ 8
2.2.1.2Mounting a Cradle on the wall.............................................................................. 10
2.2.1.3Cradle Indication Lights........................................................................................ 11
2.2.1.4Calibration Cavities and Issues ............................................................................ 11
2.2.1.5Installing the Thermal Printer ............................................................................... 11
2.2.1.6Installing Paper in the Thermal Printer................................................................. 12
2.2.1.7 Installing Bluetooth for direct printing with HP Officejet H470, HP Deskjet 6940
or thermal printer .................................................................................................. 12
2.2.1.8Installing Titan and its Battery .............................................................................. 13
2.2.1.9Charging the Battery............................................................................................. 14
2.2.1.10Battery Lifetime and Charging Time................................................................. 14
2.2.1.11Changing Probes and Extension Cords on the Titan ....................................... 15
2.2.1.12Connecting transducers to the shoulder box and PreAmp............................... 16
2.2.2Safety Precautions to take when connecting the Titan. ............................................... 17
2.2.3Software and Driver Installation ................................................................................... 23
2.2.3.1Before you start installation .................................................................................. 23
2.2.3.2Software Installation ............................................................................................. 23
2.2.3.3Installation of the Driver........................................................................................ 25
2.2.3.4Installation of NOAH Toolbar shortcut.................................................................. 25
2.2.3.5Standalone Use of Titan Suite.............................................................................. 26
2.2.3.6License ................................................................................................................. 26
2.2.3.7PC controlled Measurements with use of Bluetooth connection .......................... 26
2.2.4Selection of transducers............................................................................................... 26
2.2.5Handling and selection of ear tips ................................................................................ 27
2.2.6Placing and using the Shoulder Box or PreAmplifier ................................................... 28
2.2.7Placing the Montage-Indication Stickers on the PreAmplifier ...................................... 29
2.3Cleaning the Probe Tip..................................................................................................... 29
3Technical Specifications........................................................................................................ 31
4Return Report – form 001....................................................................................................... 39

Titan Setup and Installation Manual Page 1
1Introduction
1.1 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 acoustics reflex. 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 ABRIS440 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.
1.1.1 Typical Applications
Titan is well suited for screening, as well as
diagnostic work. Newborn screening
programs will particularly appreciate the
Automated Auditory Brainstem Response
(AABR) test implemented under the ABRIS
module and the option to create user
defined PASS/REFER protocols for DPOAE
screening. The presence of the 1000Hz
probe tone for tympanometry also allows
more reliable tympanometry results in
infants.
Titan, as a screener, will typically be
operated as a hand held device. Results
can be printed using the (Bluetooth) thermal
printer or a Bluetooth PC printer. Optionally,
measurements can be transferred later to a
database on your PC for printing.
In combination with the cradle and shoulder
box for IMP440 and DPOAE440, the Titan
gives you more flexibility in placing the
probe. Choice of ear, start and stop of the
measurement can be controlled from the
shoulder box.
In combination with the Preamplifier (PreAmp), the Titan is capable of performing the full range of
tests from the ABRIS440, DPOAE440 and IMP440 modules.
The Titan, when licensed with a diagnostic or clinical version of the IMP440 or DPOAE440
software, is generally operated via the PC. PC operation allows access to advanced testing
parameters, for example, it permits manual pressure control within the impedance module and the
ability to add extra test points in DPOAE after testing. Testing is as quick in PC controlled mode as
when using the handheld device. Results are saved in your database and can be printed on an
external printer. Protocols can be modified with all the flexibility you need.

Titan Setup and Installation Manual Page 2
1.2 Safety Notes
It is recommended that all staff working with the Titan read this manual and thereby learn the
precautionary measures.
1. External equipment intended for connection to signal input, signal output or other
connector, shall comply with the relevant IEC standard (e.g. IEC 60950 for IT equipment
and the IEC 60601 series for medical electrical equipment). In addition, all such
combinations - systems - shall comply with the standard 60601-1-1, Safety requirements
for medical electrical systems. Equipment not complying with IEC 60601 shall be kept
outside the patient environment, as defined in the standard (at least 1.5 m from the
patient).
2. Any person who connects external equipment to signal input, signal output or other
connectors has created a system and is therefore responsible for the system complying
with the requirements of IEC 60601-1-1. If in doubt, contact your service technician or local
representative for help.
3. In order to comply with IEC 60601, use of the direct power adapter to mains for the thermal
printer when it is connected to the cradle is not permitted. The cradle connection provides
power for the thermal printer.
4. 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.
1. Use this device only as described in this manual.
2. Use only the disposable Interacoustics ear tips designed for use with this instrument.
3. Never insert the probe tip into the ear canal without affixing an ear tip as omission may
damage the patient’s ear canal.
4. Keep the box of ear tips outside the reach of the patient.
5. Be sure to insert the probe tip in a way which will assure an airtight fit without causing any
harm to the patient. Use of a correct and clean ear tip is mandatory.
6. Be sure to use only stimulation intensities acceptable to the patient.
WARNING indicates a hazardous situation which, if not avoided, could
result in death or serious injury.
CAUTION, used with the safety alert symbol, indicates a hazardous
situation which, if not avoided, could result in minor or moderate injury.
NOTICE is used to address practices not related to personal injury.

Titan Setup and Installation Manual Page 3
7. When presenting contralateral stimuli using the insert phones – do not insert the phones or
in any way try to conduct measurements, without a correct insert ear tip in place.
8. When presenting contralateral stimuli using headphones – do not try to conduct
measurements without the MX41 cushion in place.
9. Clean the headphone cushion regularly using a recognized disinfectant.
10. We recommend using a new ear tip for each patient.
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. OSHA defines a quiet room for audiometric hearing testing in
its guideline OSHA 29 CFR 1910.95.
3. It is recommended that the instrument be operated within an ambient temperature range of
15°C / 59°F – 35°C / 95°F.
4. Storage in temperatures below 0°C /32°F and above 50°C /122°F may cause permanent
damage to the instrument and its accessories.
5. The headphone and insert phone are calibrated to the shoulder box of this instrument –
introducing transducers from other equipment requires a re-calibration.
6. Never clean the transducer housing with water or insert non-specified instruments into the
transducer.
7. 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.
8. 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.
9. The temperature of the battery pack in the thermal printer will rise if it is powered through
both the printer’s power supply and through the RJ12 cable to the cradle. Use either one or
the other power connections, but never both, as this may severely reduce the lifetime of
the battery.
10. The connectors marked with the symbol shown below should not be touched without taking
necessary ESD (electrostatic discharge) precautions.
11. 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.

Titan Setup and Installation Manual Page 4
The precautionary symbol:
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.
1.3 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;
•subject to misuse or negligence or accident, or that has had the serial or lot number
altered, defaced or removed; or
•improperly maintained or used in any manner other than in accordance with the
instructions provided by Interacoustics.
This warranty is in lieu of all other warranties, express or implied, and of all other obligations or
liabilities of Interacoustics. Interacoustics does not give or grant, directly or indirectly, the
authority to any representative or other person to assume on behalf of Interacoustics any other
liability in connection with the sale of Interacoustics products.
INTERACOUSTICS DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED,
INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FOR FUNCTION OF FITNESS
FOR A PARTICULAR PURPOSE OR APPLICATION.

Titan Setup and Installation Manual Page 5
1.4 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 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.
3 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.
4 For maximum electrical safety, turn off the power from a mains powered instrument when it is
left unused.
5 Do not place the instrument next to a heat source of any kind, and allow sufficient space
around the instrument to ensure proper ventilation.
6 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.
7 If the surface of the instrument or parts of it are contaminated, it can be cleaned using a soft
cloth moistened with a mild solution of water and detergent or similar. The use of organic
solvents and aromatic oils must be avoided. 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.
8 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 ear tips 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. The use of organic solvents and aromatic oils must
be avoided.
9 Great care should be exercise when handling transducers, as rough handling, for example
dropping onto a hard surface may break or damage the parts.
1.5 Unpacking and Inspection
Check the box and its 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.
Keep the carton for future shipment
The Titan comes in its own shipping carton, which is specially designed for the Titan. Please keep
this carton. It will be needed if the instrument has to be returned for service.
If service is required please contact your local distributor.

Titan Setup and Installation Manual Page 6
1.6 Reporting Damage
Inspect before connection
Prior to connecting the product to the mains it should re-inspected for damage. The entire cabinet
and accessories should be checked visually for scratches and missing parts.
Report immediately any faults
Any missing part or malfunction should be reported immediately to the supplier of the instrument
together with the invoice, serial number, and a detailed report of the problem. In the back of this
manual you will find a "Return Report" where you can describe the problem.
Please use the "Return Report"
Completion of the Return Report is advisable so that the service engineer can easily understand
the problem being reported and correct/repair to your satisfaction. Without this relevant
information, it may be difficult to determine where the fault/problem lies.
1.7 Concerning Maintenance and 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:
•assembly operations, extensions, readjustments, modifications or repairs are carried out by
authorized persons,
•a 1 year service interval is maintained
•the electrical installation of the relevant room complies with the appropriate requirements, and
•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 Interacoustics, Drejervaenget 8, DK-5610 Assens, Denmark. 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).