AmpliVox Otowave 302 User manual

Otowave 302
Operating Manual

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D-0115696-C (OM038) –Otowave 302 Operating Manual
ABOUT THIS MANUAL
READ THIS OPERATING MANUAL BEFORE ATTEMPTING TO USE THE INSTRUMENT.
This manual is valid for the Otowave 302. This product is manufactured by:
Amplivox Ltd.
6 Oasis Park, Eynsham
Oxfordshire, OX29 4TP
United Kingdom
www.amplivox.ltd.uk
Amplivox Ltd.
10393 West 70th Street
Eden Prairie
MN 55344
www.amplivox.us
For all enquiries please contact us under:
Tel: [phone]
Fax: [phone]
[email protected]k
Tel: [phone]
Fax: [phone]
[email protected]

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D-0115696-C (OM038) –Otowave 302 Operating Manual
TABLE OF CONTENTS
1. INTRODUCTION.................................................................................................................................................. 1
1.1. THANK YOU........................................................................................................................................................... 1
1.2. INTENDED APPLICATIONS ......................................................................................................................................... 1
1.3. CONTRADICTIONS................................................................................................................................................... 1
1.4. STANDARD AND OPTIONAL COMPONENTS.................................................................................................................... 2
1.5. WARNINGS ........................................................................................................................................................... 3
2. UNPACKING AND INSTALLATION........................................................................................................................ 4
2.1. GENERAL .............................................................................................................................................................. 4
2.2. MARKINGS............................................................................................................................................................ 4
2.3. SAFETY INSTRUCTIONS............................................................................................................................................. 5
2.3.1. General ..................................................................................................................................................... 5
2.3.2. Cautions –General ................................................................................................................................... 5
2.3.3. Environmental factors .............................................................................................................................. 6
2.3.4. Electrical and electrostatic safety............................................................................................................. 7
2.3.5. Electromagnetic compatibility (EMC) ....................................................................................................... 7
2.3.6. Explosion hazards ..................................................................................................................................... 7
2.3.7. Measuring Security ................................................................................................................................... 8
2.3.8. Miscellaneous ........................................................................................................................................... 8
2.3.9. Use of equipment after transport and storage......................................................................................... 8
2.4. CONNECTIONS ....................................................................................................................................................... 9
2.5. CONTROLS AND INDICATORS (BASE UNIT)................................................................................................................. 10
2.6. CONTROLS AND INDICATORS (PROBE) ...................................................................................................................... 11
2.6.1. The Probe Head ...................................................................................................................................... 11
2.7. LIGHT INDICATORS................................................................................................................................................ 12
2.8. CONTRALATERAL TRANSDUCER................................................................................................................................ 12
2.9. CHOOSING THE CORRECT EAR TIPSIZE ...................................................................................................................... 12
2.10. HARDWARE INSTALLATION ..................................................................................................................................... 13
2.11. INITIAL SETTINGS .................................................................................................................................................. 13
2.11.1. Operating language................................................................................................................................ 13
2.11.2. Date and time ......................................................................................................................................... 13
2.12. THE MPT-II PRINTER .............................................................................................................................................. 14
2.12.1. Installing the mpt-ii printer..................................................................................................................... 14
2.12.2. switching the printer on and off ............................................................................................................. 14
2.12.3. Using the printer..................................................................................................................................... 14
3. PRINCIPLES OF OPERATION ...............................................................................................................................15
3.1. OTOSCOPIC EXAMINATION ..................................................................................................................................... 15
3.2. PRINCIPALS OF ADMITTANCE MEASUREMENT............................................................................................................. 15
3.3. TYMPANOGRAM .................................................................................................................................................. 15
3.4. ACOUSTIC REFLEX MEASUREMENT............................................................................................................................ 16
4. USING THE OTOWAVE .......................................................................................................................................17
4.1. GENERAL PRECAUTIONS......................................................................................................................................... 17
4.2. SWITCHING THE INSTRUMENT ON AND OFF................................................................................................................ 18
4.3. HIGH FREQUENCY OPTION...................................................................................................................................... 18
4.4. MENU DISPLAYS .................................................................................................................................................. 18

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4.5. CONFIGURATION.................................................................................................................................................. 19
4.5.1. Sweep Settings........................................................................................................................................ 19
4.5.2. Reflex Settings ........................................................................................................................................ 20
4.5.3. System Settings....................................................................................................................................... 21
4.6. DAILY CHECK....................................................................................................................................................... 22
4.7. DISPLAY MODE.................................................................................................................................................... 22
4.8. SYSTEM INFORMATION.......................................................................................................................................... 23
4.9. PERFORMING A TEST ............................................................................................................................................. 24
4.9.1. Selecting the ear side.............................................................................................................................. 24
4.9.2. Performing tympanometry ..................................................................................................................... 24
4.9.3. Understanding the tympanometry test result ........................................................................................ 26
4.9.4. Performing tympanometry and acoustic reflex testing .......................................................................... 27
4.9.5. Understanding the acoustic reflex test result......................................................................................... 28
4.10. IMMEDIATE PROCESS OF RESULTS ........................................................................................................................ 30
4.10.1. General ................................................................................................................................................... 30
4.10.2. Sending Results to a Printer.................................................................................................................... 30
4.10.3. Saving Results to the Internal Database................................................................................................. 30
4.11. (RE)VIEW THE LAST TEST(S)................................................................................................................................... 32
4.12. DATA MANAGEMENT............................................................................................................................................ 33
4.12.1. General ................................................................................................................................................... 33
4.12.2. List records (View, Print, Delete)............................................................................................................. 33
4.12.3. Delete Records........................................................................................................................................ 34
4.12.4. Print Records........................................................................................................................................... 35
4.12.5. Data Transfer to noah or ampliSuite ...................................................................................................... 35
4.12.6. Database Full.......................................................................................................................................... 36
5. TROUBLESHOOTING ..........................................................................................................................................37
6. ROUTINE MAINTENANCE...................................................................................................................................39
6.1. GENERAL MAINTENANCE PROCEDURES .................................................................................................................... 39
6.2. CLEANING THE OTOWAVE ...................................................................................................................................... 40
6.3. CLEANING THE PROBE ........................................................................................................................................... 40
6.4. DISPOSABLES....................................................................................................................................................... 40
6.5. ACCESSORIES/REPLACEMENT PARTS ......................................................................................................................... 41
6.6. REPAIR............................................................................................................................................................... 41
6.7. WARRANTY......................................................................................................................................................... 41
6.8. WARRANTY CARD (UK CUSTOMERS ONLY)................................................................................................................ 42
6.9. CALIBRATION AND RETURN OF THE INSTRUMENT........................................................................................................ 42
7. TECHNICAL SPECIFICATIONS..............................................................................................................................43
7.1. STANDARD AND REGULATORY ................................................................................................................................. 43
7.2. GENERAL ............................................................................................................................................................ 43
7.3. TYMPANOMETRY.................................................................................................................................................. 44
7.4. ACOUSTIC REFLEX TESTING ..................................................................................................................................... 44
8. EMC GUIDANCE & MANUFACTURER’S DECLARATION .......................................................................................46
9. SAFETY PRECAUTIONS TO TAKE WHEN CONNECTING OTOWAVE 302 ...............................................................51
10. APPENDIX A –1000 HZ TYPANOMETRY & MEATUS COMPENSATION............................................................53
10.1. TYMPANOMETRIC PROPERTIES ................................................................................................................................ 53
10.2. TYMPANOMETRIC MEASUREMENTS ......................................................................................................................... 53

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10.3. SCALAR VS.VECTOR BASELINE ................................................................................................................................. 55
10.4. REFERENCE POINT FOR BASELINE VALUE..................................................................................................................... 56
11. APPENDIX B –BASELINE MODE......................................................................................................................57
11.1. GENERAL ............................................................................................................................................................ 57
11.2. 226 HZ TYMPANOMETRY –Y COMPENSATION ONLY.................................................................................................... 57
11.3. 1000 HZ TYMPANOMETRY ..................................................................................................................................... 58
11.3.1. scalar Mode –y-compensation............................................................................................................... 58
11.3.2. Vector Mode –b-g-compensation .......................................................................................................... 58
11.3.3. Component Mode –YBG......................................................................................................................... 58

INTRODUCTION
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D-0115696-C (OM038) –Otowave 302 Operating Manual
1. INTRODUCTION
1.1. THANK YOU
Thank you for purchasing an Amplivox Otowave 302, a desktop controlled impedance meter that will give many
years of reliable service if treated with care.
This operating manual applies to the Otowave 302 which is available as a standard option (with 226Hz probe
tone) and as an H-option (1000Hz probe tone in addition).
1.2. INTENDED APPLICATIONS
This instrument is designed for use by trained personnel only, such as audiologists, ENT surgeons, doctors,
general practitioners, hearing aid dispensers, child health professionals and hearing healthcare professionals
with a similar level of education. It is not recommended to utilize the equipment without the necessary
knowledge and training.
The Otowave is to be used to obtain information on medical and functional conditions of the middle and outer
ear as well as to assess hearing functions throughout acoustic reflex testing. The Otowave 302 can be used
on all ages and performs the following kinds of measurements:
Tympanometry: To measure the compliance of the tympanic membrane and middle ear at 226 or
1000 Hz over a range of pressures.
Acoustic Reflex Testing: The Otowave measures both ipsilateral and contralateral acoustical
reflexes. The tests are performed either at ambient or peak pressure, based on the outcome of the
tympanometry.
1.3. CONTRADICTIONS
Always visually inspect the outer ear and the external auditory canal for abnormalities before testing. Testing
should not be performed on patients in the following items is applicable.
Acute external auditory canal trauma
Discomfort (e.g. severe otitis externa)
Occlusion of the external auditory canal
Discharging ear
Recent stapedectomy or middle ear surgery
Presence of tinnitus, hyperacusis or other sensitivity to loud sounds may contraindicate testing when
high intensity stimuli are used

INTRODUCTION
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D-0115696-C (OM038) –Otowave 302 Operating Manual
1.4. STANDARD AND OPTIONAL COMPONENTS
Shipping documentation will reference the stock number quoted above, and images of the parts alongside the
relevant stock number are available on the Amplivox website (www.amplivox.ltd.uk). The required fitting
instructions are supplied with each part.
STANDARD COMPONENTS
Otowave 302 Tympanometer
8508021
Contralateral reflex transducer (probe
tip & earpiece lead)
85021771
Power Supply - FW7660M/05
8006059
Set of disposable ear-tips
80293441
CD with Software (ampliSuite and
Noah impedance module) and
Operating Manuals
8506719
4 in 1 cavity assembly
(0.2 ml/0.5 ml/2.0 ml/5.0 ml)
8011362
Cable USB a to USB B (1.8 m)
8507230
Carrying case
8507539
Calibration certificate
Warranty card
OPTIONAL COMPONENTS
Sanibel MPT-II Thermal Printer
8503007
Thermal Printer paper for Sanibel
MPT-II
8029305
Probe tip for contralateral reflex
transducer
80011181
Earpiece lead for contralateral
reflex transducer
8004447
Additional sets of ear tips
Probe tip
80025921
Otowave probe assembly
W0071
Seal (in probe tip)
80020091
OTHER COMPONENTS TO REORDER
Printer cable –Otowave to Sanibel
MPT-II
A102
Power supply for printer
Probe tip for contralateral reflex
transducer
80011181
Earpiece lead for contralateral
reflex transducer
8004447
Otowave probe assembly
W0071
Seal (in probe tip)
80020091
Ear tip Otowave 3-5mm
T205
Ear tip Otowave 4-7mm
T206
Ear tip Otowave 7mm
T207
Ear tip Otowave 8mm
T208
Ear tip Otowave 9mm
T209
Ear tip Otowave 10mm
T210
Ear tip Otowave 11mm
T211
Ear tip Otowave 12mm
T212
Ear tip Otowave 13mm
T213
Ear tip Otowave 14mm
T214
Ear tip Otowave 15mm
T215
Ear tip Otowave 19mm
T219
1
Applied part as according to IEC 60601-1

INTRODUCTION
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D-0115696-C (OM038) –Otowave 302 Operating Manual
1.5. WARNINGS
Throughout this manual, the following meanings of warnings and cautions apply:
The WARNING label identifies conditions or practices that may present danger
to the patient and/or user.
The CAUTION label identifies conditions or practices that could result in damage
to the equipment.
WARNING
CAUTION

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D-0115696-C (OM038) –Otowave 302 Operating Manual
2. UNPACKING AND INSTALLATION
2.1. GENERAL
Please check the contents of the shipping carton against the delivery note to make sure that all items ordered
have been included. If anything is missing, please contact the distributor who supplied the tympanometer or
Amplivox if purchased directly.
Please retain the carton and packaging as the instrument will need calibrating on an annual basis and should
be returned to Amplivox in its original shipping carton.
For supply in US only: Federal Law restricts this device to sale by or on the order of a licensed medical
professional.
2.2. MARKINGS
The following markings can be found:
Symbol
Explanation
Type B applied parts. According to IEC 60601-1.
Patient applied parts that are not conductive and can be immediately released from the
patient.
Refer to instruction manual.
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.
0476
The CE-mark indicates that Amplivox Ltd. 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.
Serial number.
Date of manufacture.
The output from the mains AC adapter is Direct Current.
Do not re-use.
Ear-tips and similar are for single use only.
CAUTION

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D-0115696-C (OM038) –Otowave 302 Operating Manual
Keep dry.
Transport and storage humidity range.
Transport and storage temperature range.
Logo.
Turns the instrument on or off. Long press to turn off. Short press to wake the device
from sleep mode (display off).
2.3. SAFETY INSTRUCTIONS
2.3.1. GENERAL
The following safety precautions must be observed at all times. General safety precautions must be followed
when operating electrical equipment. Failure to observe these precautions could result in damage to the
equipment and injury to the operator or patient.
The employer should instruct each employee in the recognition and avoidance of unsafe conditions and the
regulations applicable to his or her work environment to control or eliminate any hazards or other exposure to
illness or injury.
Amplivox Ltd. is aware that safety rules within individual organizations vary. If a conflict exists between the
instructions in this manual and the rules of the organization using this instrument, the more stringent rules
should take precedence.
The Otowave 302 is intended to be used by hearing healthcare professionals (i.e. ENT doctors, audiologists),
nurses or technicians who have been trained in the proper use of the device.
2.3.2. CAUTIONS –GENERAL
If the system is not functioning properly, do not operate it until all necessary repairs are made and the unit is
tested and calibrated for proper functioning in accordance with Amplivox’s specifications.
Do not drop or in any other way cause undue impact to this device. If the instrument is damaged, return it to
the manufacturer for repair and/or calibration. Do not use the instrument if any damage is suspected.
This product and its components will perform reliably only when operated and maintained in accordance with
the instructions contained in this manual, accompanying labels, and/or inserts. A defective product should not
CAUTION

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D-0115696-C (OM038) –Otowave 302 Operating Manual
be used. Make sure all connections to external accessories are secured properly. Parts which may be broken
or missing or are visibly worn, distorted, or contaminated should be replaced immediately with clean, genuine
replacement parts manufactured by or available from Amplivox Ltd.
Equipment is not user repairable. Repairs must be performed by an authorized service representative only.
No modifications of the equipment are allowed by anyone other than a qualified Amplivox Ltd. representative.
Modification of the equipment could be hazardous.
Amplivox Ltd. will make available on request circuit diagrams, component part lists, descriptions, calibrations
instructions, or other information that will assist authorized service personnel to repair those parts of this
instrument that are designated by Amplivox Ltd. as repairable by service personnel.
No parts of the equipment can be serviced or maintained while in use with the patient.
Connect only accessories purchased from Amplivox Ltd. to the Otowave 302. Only accessories which have
been stated by Amplivox Ltd. to be compatible are allowed to be connected to the device or cradle.
To comply with the standards IEC 60601-1 for safety and IEC 60601-1-2 for electromagnetic compatibility
(EMC) the tympanometer is designed to be used only with the medically-approved mains adapter supplied,
which is specified as part of the equipment. Do not use any other type of mains adapter with this
instrument.
The output from the mains adapter is fitted with electronic circuit protection. In case of overload the adapter
will shut down and the indicator will be extinguished. When the fault is cleared the adapter will operate as
normal.
The input to the mains adapter is protected with a non-replaceable fuse. If this fails the adapter will not operate.
The mains adapter is the mains disconnect device and therefore the tympanometer should be positioned such
that easy access to the mains adapter is possible.
2.3.3. ENVIRONMENTAL FACTORS
Use and store the instrument indoors only. It is recommended that the instrument
be operated within an ambient temperature range of 15 °C / 59 °F to 35 °C / 95 °F
and in relative humidity between 30 % and 90 % (non-condensing).
Do not use the device in the presence of fluid that can come into contact with any of the electronic components
or wiring. Should the user suspect fluids have contacted the system components or accessories, the unit
should not be used until deemed safe by an authorized service technician.
As with all instruments of this nature the measurements taken will be influenced by significant changes in
altitude & pressure. The Otowave 302 tympanometer must be re-calibrated if it is to be used at elevations
greater than 800 m above mean sea level.
CAUTION

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D-0115696-C (OM038) –Otowave 302 Operating Manual
2.3.4. ELECTRICAL AND ELECTROSTATIC SAFETY
Before performing any service to the insert earphones you must uncouple the
Otowave 302 transducers from the patient.
Do not touch the contacts on the back of the instrument and the patient at the
same time. The consequence could be a too high leakage current to the patient.
Do not open the case of the instrument. Refer servicing to qualified personnel.
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 must 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 –must comply with the
safety requirements stated in the general standard IEC 60601-1, (edition 3.1), clause 16. Any equipment not
complying with the leakage current requirements in IEC 60601-1 must be kept outside the patient environment
i.e. at least 1.5m from the patient support or must 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
these requirements. If in doubt, contact a qualified medical technician or your local representative. When the
instrument is connected to a PC, or other similar items, beware of not touching the PC and patient
simultaneously.
A Separation Device (isolation device) is needed to isolate the equipment located outside the patient
environment from the equipment located inside the patient environment. In particular such a Separation Device
is required when a network connection is made. The requirement for the Separation Device is defined in IEC
60601-1 clause 16.
Do not use any additional multiple socket-outlet or extension cord. Use only FW7660M/05 Power Supply.
2.3.5. ELECTROMAGNETIC COMPATIBILITY (EMC)
Although the instrument fulfills the relevant EMC requirements, precautions
should be taken to avoid unnecessary exposure to electromagnetic fields, e.g.,
from mobile phones, etc. If the device is used adjacent to other equipment it
must be observed that no mutual disturbance appears. Please also refer to the
appendix regarding EMC.
2.3.6. EXPLOSION HAZARDS
Risk of explosion.
Do not use in the presence of flammable anesthetics or other gases.
Do NOT use in the presence of flammable gaseous mixtures. Users should
consider the possibility of explosions or fire when using this device in close
proximity to flammable anesthetic gases.
Do NOT use the Otowave 302 in a highly oxygen-enriched environment, such
as a hyperbaric chamber, oxygen tent, etc.
CAUTION
WARNING
CAUTION
WARNING

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D-0115696-C (OM038) –Otowave 302 Operating Manual
2.3.7. MEASURING SECURITY
To guarantee that the Otowave 302 works properly, the instrument should be checked and calibrated at least
once a year. The transducers supplied with the tympanometer are specifically calibrated with it; if these
transducers are changed recalibration will be required.
The service and calibration must be performed by an authorized service technician. If these checks are not
performed, EU Medical Device Directive (MDD) and other regulations may be violated and warranties may be
void.
The use of non-calibrated devices can lead to incorrect test results and is not advisable.
2.3.8. MISCELLANEOUS
Please note: DO NOT connect the Otowave 302 hardware to the computer before the software has been
installed!
Storage in temperatures below 0C /32F and above 50C /122F may cause permanent damage to the
instrument and its accessories.
Do not place the instrument next to a heat source of any kind.
Great care should be exercised when handling transducers, as rough handling, for example dropping onto a
hard surface may break or damage the parts.
Within the European Union it is illegal to dispose of electrical and electronic waste as unsorted
municipal waste. Electrical and electronic waste may contain hazardous substances and
therefore have to be disposed of separately. Such products will be marked with the crossed-
out wheelie-bin image shown to the left. User cooperation is important in order to ensure a
high level of reuse and recycling of electrical and electronic waste. Failure to recycle such
waste products in an appropriate way may endanger the environment and consequently the
health of human beings.
Outside the European Union, local regulations should be followed when disposing of the product after its end
of life.
2.3.9. USE OF EQUIPMENT AFTER TRANSPORT AND STORAGE
Please make sure that the instrument is functioning correctly before use. If the instrument has been stored in
a cold environment (even for short period of time), please allow the instrument to become acclimatized. This
can take long time depending on the conditions (such as environmental humidity). You can reduce the
condensation by storing the instrument in its original packaging. If the instrument is stored under warmer
conditions than the actual use conditions no special precaution is required before use. Always ensure proper
operation of the instrument by following routine check procedures for audiometric equipment.

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D-0115696-C (OM038) –Otowave 302 Operating Manual
2.4. CONNECTIONS
All connections are made to the rear panel of the tympanometer as shown below.
1
Probe holder
Cavity to store probe while not in use
2
Contra phone
Contralateral transducer
3.5mm jack
3
Air channel
Connection of probe (pressure)
Push-fit connector
4
Probe
Connection of probe (electrical)
15-way D connector
5
Printer
Connection of external printer
RJ12 socket (6-way)
6
USB
Connection for computer (via USB port)
USB Connector, Type B
7
Power
Mains AC/DC Adapter
2.5mm power jack
Please note: Only connect the accessories supplied with the instrument or supplied by Amplivox or an
Amplivox distributor. These parts have been tested for use with the Amplivox Otowave 302 tympanometer for
compliance with the standards IEC 60601-1 and IEC 60601-1-2. The use of accessories other than those
specified may compromise compliance with these standards.
2
3
1
4
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D-0115696-C (OM038) –Otowave 302 Operating Manual
2.5. CONTROLS AND INDICATORS (BASE UNIT)
The Otowave consists of an LCD screen, three button groups in total to operate the instrument and three status
LEDs.
a
Power indicator
(LED a)
Lights up as soon as the instrument is powered through the mains adapters
(also when the instrument is switched off).
b
Indicator LED b
Indicates if testing is in process or not.
c
Indicator LED c
Indicates if testing is in process or not.
1
On/Off switch
Short press to switch on the device, long press to switch it off.
2
Navigation keys
Press the up ▲ and down ▼ navigation keys to scroll through the menus
or set values
Press the right navigation key ►to accept a menu choice or go to the next
step.
Press the left navigation key ◄to cancel an operation or go back to the
previous step.
The function of the left and right keys is usually shown on the bottom line
of the display.
3
Display Mode
Quick view of the test settings currently used or change of baselinemode.
1
2
3
a
b c

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2.6. CONTROLS AND INDICATORS (PROBE)
1
Indicator light
Indicates if testing is in process or not.
2
Function button
Quick view of the test settings currently used or change of baselinemode.
3
Probe tip with ear tip
2.6.1. THE PROBE HEAD
1
Boss and Nut
Connection on probe body for attaching nose cone
2
Seal rubber
Gasket used to ensure air flow
3
Probe tip
Transparent probe tip housing the seal rubber
4
Nose cone
Top part of probe to securely fasten probe tip and seal rubber
To remove the probe tip, unscrew the nose cone and remove the probe tip from the boss. A small seal will be
found in the base of the probe tip. This should be examined and replaced if it is blocked or damaged. Do not
remove the nut securing the boss to the probe body.
When replacing the probe tip, ensure that the seal is correctly located with the flat side aligned with the flat
side within the base of the probe tip. Push the probe tip over the boss and replace the nose cone. Make sure
that the nose cone is screwed home firmly but do not over-tighten. Do not use any tools to tighten the nose
cone.
After replacing the tip a Daily Check should be carried out (refer to chapter 4.6).
Video available on how to clean the probe tip.
1 2 3
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2.7. LIGHT INDICATORS
The indicators on the Otowave and the probe show the status of the system.
STATUS
LED B
LED C
PROBE
Otowave turned off
Off
Off
Off
Idle, test completed or test cancelled
On
Off
Flashing (fast)
Insert probe or remove probe (refer to display for details)
Flashing
(fast)
Flashing
(fast)
Color alternating
(Green / Yellow)
Ensure probe is held steady while an ear seal is obtained
Off
Flashing
(slow)
Yellow flashing
(slow)
Testing - tympanogram and/or reflex measurement
Flashing
(slow)
Off
Green flashing
(slow)
2.8. CONTRALATERAL TRANSDUCER
1
Ear tip
Ear tip to be placed on probe tip of contra phone
2
Probe tip
Probe tip screwed onto contra phone
3
Plug
Connector to CONTRA socket on Otowave
The contralateral transducer is used when it is required to provide a reflex stimulus to the opposite ear to that
being tested with the main probe assembly. For use it should be connected to the CONTRA socket on the
base unit and fitted with a new ear tip.
The contralateral probe tip may be replaced if necessary (e.g. if damaged). To remove the contralateral probe
tip, carefully unscrew it from the body of the transducer. Carefully fit the replacement part and make sure that
it is screwed home firmly but do not over-tighten. Do not use any tools to tighten the contralateral probe tip.
2.9. CHOOSING THE CORRECT EAR TIP SIZE
Video available on how to choose the correct ear tip.
The probe tip must be fitted with a new ear tip before it is presented to a patient’s ear canal. If a contralateral
reflex stimulus is to be applied, fit a new ear tip to the contralateral transducer before presenting it to the
patient’s opposite ear canal.
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Please note: Never insert the probe or the contralateral transducer into a patient’s ear canal without a
suitable ear tip fitted.
The ear tip size is chosen based on the diameter of the
external ear canal and should suit the patient’s ear but also
provide a comfortable pressure seal.
Ensure that the ear tip is pushed all the way down on the
probe tip and that there is no gab between probe tip and ear
tip.
The small holes through the Otowave probe tip must be kept
clear. If these become blocked a warning message will be
displayed. The probe tip must be cleaned or removed and
replaced.
2.10. HARDWARE INSTALLATION
The instrument is shipped with the probe attached to the Otowave. The instrument is designed for continuous
operation and is powered by a mains adapter. Connect the output lead from the adapter into the POWER input
socket on the back of the Otowave. When power, the indicator on the adapter and the Power indicator (LED
a) on the Otowave will both illuminate green, showing that the instrument is ready for use.
If a contralateral transducer was purchased for contralateral reflex testing, connect the transducer to the
CONTRA socket (2) on the base unit and fitted.
2.11. INITIAL SETTINGS
2.11.1. OPERATING LANGUAGE
The instrument will be set in English by default. To change the operating language (English, German, French,
Spanish, Portuguese or Italian) ensure you start from the MAIN MENU.
MAIN MENU
Select down ▼ 1x.
Confirm with ►.
CONFIGURATION
Select down ▼ 2x.
Confirm with ►.
SYSTEM SETTINGS
Select down ▼ 8x.
Confirm with ►.
SELECT LANGUAGE
Select language with ▲ / ▼.
Store with ►.
2.11.2. DATE AND TIME
The Otowave is equipped with a real-time clock. Before use, please set the date & time to local values in
order to ensure that test data and calibration status are correctly identified.

UNPACKING AND INSTALLATION
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D-0115696-C (OM038) –Otowave 302 Operating Manual
2.12. THE MPT-II PRINTER
2.12.1. INSTALLING THE MPT-II PRINTER
The Sanibel MPT-II thermal printer is available as an option for use with the Otowave 302 and is connected
using the cable supplied. The printer may be specified when ordering and only this printer should be used. It
will be correctly configured for use.
1. Open the lid by pushing on the sides, insert paper roll as shown,
and close the lid.
2. Insert the battery.
2.12.2. SWITCHING THE PRINTER ON AND OFF
Push POWER BUTTON for two seconds in order to power ON or OFF. One
short beep will be heard at power ON, two short beeps at power OFF.
The green power indicator will be lit if the printer is powered by battery.
2.12.3. USING THE PRINTER
Printer self-test:
While printer is powered OFF, press and hold PAPER FEED button, then press
and hold POWER BUTTON simultaneously. When beep is heard after approx. 3
seconds, release both buttons, and a test page will print with information on current
status and character samples.
Paper feed:
When powered, press PAPER FEED button. Paper will feed as long as the button
is pressed.
Connecting
process:
Connect the printer via the cable with the device
Power on printer
Select print option in otowave
Please note: Do not have several printers powered on and within range while
searching.

PRINCIPLES OF OPERATION
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D-0115696-C (OM038) –Otowave 302 Operating Manual
3. PRINCIPLES OF OPERATION
3.1. OTOSCOPIC EXAMINATION
A suitably-qualified health care professional should perform a thorough otoscopic examination to establish that
the condition of the ear is suitable for the test options selected and that no contraindications are present. The
latter would include obstruction of the external ear canal due to excessive wax and/or hairs, both of which
would need to be removed. This is required to ensure that the probe tone delivered by the probe are able to
reach the ear drum and are not reflected by cerumen or debris and thereby alter the test result.
3.2. PRINCIPALS OF ADMITTANCE MEASUREMENT
The Otowave 302 measures the admittance of the tympanic membrane and middle ear by playing a continuous
tone into the ear canal at either 226 Hz or 1000 Hz. The level of this tone is calibrated to give 85 dB SPL (226
Hz) or 79 dB SPL (1000 Hz) into a 2 ml cavity. The sound level this produces in the ear canal is measured
using a microphone and the admittance calculated from the result.
In line with normal audiometric practice admittance is displayed as an equivalent volume of air in ml (for 226
Hz) or mmho/mƱ (for 1000 Hz). The residual ear canal volume between the probe and the tympanic membrane
is always displayed in ml; when using a 1000 Hz probe tone the measured value in mmho is converted to ml
using a conversion factor of 226/1000.
3.3. TYMPANOGRAM
Tympanometry is part of the objective impedance test battery and provides information about the middle ear
mobility and pressure in the middle ear system.
To record the tympanogram, the admittance is measured while the air
pressure in the ear canal is varied from +200 daPa to -400 daPa by means
of a small pump. The admittance peaks when the air pressure is the same
on both sides of the tympanic membrane. The change of admittance with
pressure is displayed graphically.