AmpliVox Otowave 202 User manual

Otowave 202
Operating Manual

ABOUT THIS MANUAL
READ THIS OPERATING MANUAL BEFORE ATTEMPTING TO USE THE
INSTRUMENT.
This manual is valid for the Otowave 202. 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.ltd.us
For all enquiries please contact us under:
Tel: [phone]
Fax: [phone]
[e-mail]
Tel: [phone]
Fax: [phone]
[e-mail]

For supply in US only
Caution: Federal Law restricts this device to sale by or on the order of a
licenced medical professional.
Indications for Use
The Otowave 202 Portable Tympanometer is designed for use by trained
operators (audiologists, general practitioners, hearing aid dispensers, and
child health professionals) in hospitals, ENT clinics, and audiologist offices
for the detection of possible otologic disorders in the general population
associated with the functioning of the middle ear.
The instrument performs two types of measurement:
Tympanometry is used to measure the acoustic admittance (which is also
known as “compliance”) of the tympanic membrane and middle ear at a
fixed frequency over a range of pressures.
Reflex tests are used to measure stapedial reflexes. The Otowave 202
measures ipsilateral reflexes and, when selected, reflex measurement is
automatically carried out after a tympanogram is taken.
Release date: June 21st 2017

D-0115696-B Otowave 202 Operating Manual Page 1
CONTENTS
1. Introduction......................................................................................3
1.1. Intended applications.........................................................................3
1.2. Features ............................................................................................3
1.3. Unpacking..........................................................................................4
1.4. Standard contents .............................................................................4
1.5. Optional accessories.........................................................................4
1.6. Warranty card (UK Customers only)..................................................4
1.7. Guarantee..........................................................................................4
2. Important Safety Instructions.........................................................5
2.1. Precautions........................................................................................5
2.2. Electromagnetic compatibility (EMC) considerations ........................6
2.3. Power supply options ........................................................................7
2.4. Tympanometer connections..............................................................8
2.5. Data transfer to a printer....................................................................8
2.6. Data transfer to a computer...............................................................9
3. Principles of Operation...................................................................9
3.1. Admittance measurement..................................................................9
3.2. Tympanogram ...................................................................................9
3.3. Stapedial reflex measurement.........................................................10
4. Using the Otowave........................................................................10
4.1. Installing & replacing batteries ........................................................10
4.2. Operating language.........................................................................11
4.3. Controls and indicators (base unit)..................................................11
4.4. Controls and indicators (probe).......................................................12
4.5. Indicators and system status...........................................................12
4.6. Probe components ..........................................................................13
4.7. Contralateral transducer..................................................................14
4.8. Start-up and menu displays.............................................................14
4.9. Initial settings...................................................................................15
5. Taking Measurements...................................................................15
5.1. Prior to testing and ambient conditions ...........................................16
5.2. Test arrangement............................................................................16
5.3. Ear tip(s)..........................................................................................17
5.4. Performing a test.............................................................................18
5.5. Sweep settings................................................................................24
5.6. Reflex options..................................................................................29
5.7. Error messages...............................................................................30
6. Saving Results in the Internal Database.....................................30
6.1. Data entry........................................................................................30
6.2. Database full....................................................................................31
7. Sending the Results to a Printer..................................................31
8. Data Transfer to NOAH or TympView..........................................34

Page 2 D-0115696-B Otowave 202 Operating Manual
9. Data Management..........................................................................35
9.1. List records......................................................................................35
9.2. Delete records.................................................................................36
9.3. Print records....................................................................................37
9.4. Connect via USB.............................................................................37
10. Performing Daily Checks..............................................................37
11. Routine Maintenance ....................................................................38
11.1. Cleaning the Otowave.....................................................................38
11.2. Eartips and Probe............................................................................39
11.3. Calibration and Return of the Instrument.........................................39
12. Menu Summary..............................................................................40
12.1. Main menu.......................................................................................40
12.2. Sub-Menu selections.......................................................................40
13. Error Messages & Fault Conditions.............................................44
14. Technical Specification.................................................................48
14.1. Performance....................................................................................48
14.2. Equipment classification..................................................................52
14.3. Symbols...........................................................................................52
15. Ordering Consumables and Accessories...................................54
16. Disposal Information.....................................................................55
17. EMC Guidance & Manufacturer’s Declaration ............................56
18. Use with Non-medical Electrical Equipment...............................62
19. 1000Hz Tympanometry and Meatus Compensation...................67
19.1. Tympanometric Properties ..............................................................67
19.2. Tympanometric Measurements.......................................................67
19.3. Additional Points to Consider ..........................................................69

D-0115696-B Otowave 202 Operating Manual Page 3
1. Introduction
Thank you for purchasing the Amplivox Otowave 202, a portable
tympanometer incorporating an ergonomically-designed remote probe
assembly that will give many years of reliable service if treated with care.
This operating manual applies to the Otowave 202 which is available as a
standard option (with 226Hz probe tone) and as an H-option (with 226Hz
and 1000Hz probe tones). Text that applies to 1000Hz operation only is
marked H.
1.1. Intended applications
The Otowave 202 is designed for use by audiologists, general practitioners,
hearing aid dispensers and child health professionals.
The instrument performs two types of measurement:
Tympanometry is used to measure the acoustic admittance (which is also
known as “compliance”) of the tympanic membrane and middle ear at a
fixed frequency over a range of pressures.
Reflex tests are used to measure stapedial reflexes. When selected, reflex
measurement is automatically carried out after a tympanogram is taken.
1.2. Features
Automatic measurement of ear canal volume, tympanic admittance
peak and placement of the peak using either 226Hz or 1000Hz H
probe tone with various display options for the tympanometric data
Automatic detection of stapedial reflexes using a choice of
ipsilateral and/or contralateral reflex stimulus
Choice of frequency and level for reflex stimulus
Up to 18, dual-ear patient tests can be stored in non-volatile
memory
An intuitive menu system for operation, setting test options and
other user preferences, held in non-volatile memory
Printout via an infrared (IrDA) link to one of two thermal printers
that may be selected by the user
Data transfer to computer via a USB connection for storage,
viewing & printing using either the Amplivox “TympView” software
or the NOAH application

Page 4 D-0115696-B Otowave 202 Operating Manual
English, German, French, Spanish, Portuguese or Italian operating
language (selectable by the user)
1.3. Unpacking
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 original shipping carton and packaging to transport the
tympanometer for annual calibration or repair.
1.4. Standard contents
Otowave 202 Tympanometer Detachable probe assembly
Mains adapter Contralateral transducer
4 x 1.5V Alkaline ‘AA’ Batteries 4 in 1 cavity assembly
Set of disposable ear-tips Carrying case
Operating manual & TympView Calibration certificate
NOAH impedance module Warranty card
1.5. Optional accessories
Additional sets of ear tips Additional probe tip
Portable thermal printer USB cable
Additional rolls of thermal paper
1.6. Warranty card (UK Customers only)
Please complete the enclosed warranty registration card and return it to
Amplivox. This will enable us to register your purchase, help with your
enquiries and provide technical support.
1.7. Guarantee
All Amplivox instruments are guaranteed against faulty materials and
manufacture. The instrument will be repaired free of charge for a period of
two years from the date of dispatch if returned, carriage paid, to the
Amplivox service department. Return carriage is free of charge for
customers in the UK and chargeable for overseas customers.

D-0115696-B Otowave 202 Operating Manual Page 5
The following exceptions apply:
The pressure pump and transducers may go out of
calibration due to rough handling or impact (dropping)
The lifetime of probe, probe seals and eartips is
dependent upon conditions of use. These parts are
only guaranteed against faulty materials or
manufacture.
2. Important Safety Instructions
The Otowave 202 instrument must be used only by
practitioners qualified to perform tympanometric tests. It
is intended for transient use as a screening and
diagnostic tool; however no surgical or medical
procedure should be undertaken solely on the basis of
results obtained from the instrument.
2.1. Precautions
READ THIS OPERATING MANUAL BEFORE ATTEMPTING TO USE
THE INSTRUMENT
To comply with the standards IEC 60601-1 for safety and IEC 60601-1-2
for 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. Refer to Section 15 for the stock number of the adapter.
The tympanometer is for indoor use only and should be used only as
described in this manual.
The transducers supplied with the tympanometer are specifically calibrated
with it; if these transducers are changed recalibration will be required.
When using the instrument with batteries refer to the precautions specified
in Sections 2.3 and 4.1.
Before the first use of the instrument each day, or if suspect or inconsistent
results are apparent, the checks specified in Section 10 must be carried
out. If these do not give the results specified, the instrument must not be
used.

Page 6 D-0115696-B Otowave 202 Operating Manual
Never insert the probe or the contralateral transducer into a patient’s ear
canal without a suitable ear tip fitted.
Use only the recommended disposable ear tips for the probe and the
contralateral transducer (see Section 15 for details). These are for single
use only - that is, each ear tip is intended to be used once only for a single
ear for a single patient. Do not reuse ear tips as this will pose the risk of
ear-to-ear or patient-to-patient cross infection.
Do not immerse the unit in any fluids. See Section 11 of this manual for the
proper cleaning procedure for the instrument and its accessories and the
function of single-use parts.
Do not use the instrument in an oxygen-rich environment or in the presence
of a flammable anaesthetic mixture or other flammable agents.
Do not drop or otherwise impact this instrument. If the instrument is
dropped or damaged, return it to the manufacturer for repair and/or
calibration. Do not use the instrument if any damage is suspected.
The instrument must be stored and used indoors within the specified
temperature, pressure and humidity ranges, see Section 14.
As with all instruments of this nature the measurements taken will be
influenced by significant changes in altitude & pressure. The Otowave 202
tympanometer must be re-calibrated if it is to be used at elevations greater
than 800m above mean sea level.
Do not attempt to open, modify or service the instrument. Return the
instrument to the manufacturer or distributor for all repair and servicing
requirements. Opening the instrument will void the warranty.
2.2. Electromagnetic compatibility (EMC) considerations
Medical electrical equipment needs special precautions regarding EMC and
needs to be installed and put into service according to the EMC information
provided in Section 17. This provides guidance on the electromagnetic
environment in which to operate the instrument.
Portable and mobile radio-frequency (RF) communications equipment can
affect medical electrical equipment. The instrument should not be used
adjacent to or stacked with other equipment; if this is necessary the
instrument should be observed to verify normal operation.

D-0115696-B Otowave 202 Operating Manual Page 7
2.3. Power supply options
The tympanometer is designed for continuous operation and may be
powered either by a mains adapter (which is supplied, and specified as part
of the equipment) or optional internal batteries.
Do not connect or disconnect the mains adapter lead
while the instrument is operational as this may cause it
to shut down. Always switch off first (see Section 4.3).
Rechargeable batteries must be charged outside of the
instrument –they are not charged by the mains
adapter when this used.
Battery operation
Refer to Section 4.1 regarding the types of battery that may be used and
their installation, replacement and other precautions. Note that local
regulations are likely to cover disposal of used batteries.
Mains operation
All other connections must be made before connecting the output lead from
the adapter into the POWER socket on the front face of the tympanometer.
Switch on the mains supply - the indicator on the adapter will illuminate
green.
The output from 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.
If a replacement mains adapter is required, please contact Amplivox or
your Amplivox distributor.

Page 8 D-0115696-B Otowave 202 Operating Manual
2.4. Tympanometer connections
All the relevant accessory terminals and connections are labelled to ensure
correct identification and connection as follows:-
Socket Label
Socket Type
Connected Part
Notes
PROBE
15-way D connector
Remote probe (electrical) *
AIR
4mm (nominal) Luer
Remote probe (pressure) *
CONTRA
3.5mm jack
Contralateral transducer *
USB Connector
Type B
Computer (via USB port)
See 2.6
POWER
2.5mm power jack
Mains AC/DC Adapter *
The relevant part numbers are indicated in Section 15.
For connected parts marked * 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 Otowave 202
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. For other sockets
refer to Section 18.
2.5. Data transfer to a printer
Please refer to Section 18 for important information
regarding the connection of non-medical electrical
equipment to medical electrical equipment
The tympanometer can be upgraded with an option to allow connection via
the infrared (IrDA) link to one of two designated portable thermal printers

D-0115696-B Otowave 202 Operating Manual Page 9
for printing tympanometric test results (see Section 7). Upon receipt of the
printer it must be initially charged for a minimum of 15 hours prior to use.
2.6. Data transfer to a computer
Please refer to Section 18 for important information
regarding the connection of non-medical electrical
equipment to medical electrical equipment
The tympanometer is supplied with software to allow connection to a
computer for the transfer of test results (see Section 8). You must use the
designated USB cable which is available from Amplivox (see Section 15).
3. Principles of Operation
Please note: This operating manual is not intended as a training manual
for tympanometry. The reader should consult standard audiology texts for
the theory and application of the screening tests provided by this
instrument.
3.1. Admittance measurement
The Otowave 202 measures the admittance of the tympanic membrane
and middle ear by playing a continuous tone into the ear canal at either
226Hz or 1000Hz H. The level of this tone is calibrated to give 85dB SPL
(226Hz) or 79dB SPL (1000Hz H) into a 2ml 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
226Hz) or mmho/mƱ (for 1000Hz H).
3.2. Tympanogram
To record the tympanogram the admittance is measured while the air
pressure in the ear canal is varied from +200daPa to -400daPa 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.

Page 10 D-0115696-B Otowave 202 Operating Manual
3.3. Stapedial reflex measurement
Using the same principle it is also possible to establish whether a stapedial
reflex is present. In this case, the 226Hz tone is used to measure the
admittance of the ear, while a short tone at a different frequency is
presented (the reflex stimulus). The level of this stimulus is increased in
steps until the stapedial muscles respond causing the tympanic membrane
to become stiffer, or a preset maximum level is reached. When the change
in admittance exceeds a predetermined threshold this constitutes a reflex
and the change in admittance at that level when the stimulus is applied is
displayed as a plot against time.
The stapedial reflex is measured at the static ear canal pressure that
produces the maximum membrane admittance, so reflex measurements
are taken after the tympanogram is measured when the peak admittance
pressure has been established.
The reflex stimulus may be produced in the ear being measured (ipsilateral
mode), the opposite ear (contralateral mode) or in both ears (ipsilateral
mode followed by contralateral mode). For contralateral stimulation the
reflex tone is produced in a separate transducer supplied with the
instrument.
The Otowave 202 can measure a stapedial reflex at 500Hz, 1000Hz,
2000Hz and 4000Hz; any combination of these frequencies may be
selected for ipsilateral and contralateral mode. The maximum level for the
reflex stimulus may be preset, along with the step size in dB between the
three preceding lower levels of stimulus (see Section 5.7).
4. Using the Otowave
This instrument 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. Refer to Section 12.2.
4.1. Installing & replacing batteries
The Otowave 202 may be powered from Alkaline ‘AA’ batteries or
rechargeable Nickel-Metal Hydride (NiMH) batteries (see Section 14). Four
batteries are required. Do not mix battery types or old and new batteries.

D-0115696-B Otowave 202 Operating Manual Page
11
If the Otowave is to be used infrequently the use of alkaline cells is
recommended. NiMH batteries have a high self-discharge rate and are
likely to need recharging if left unused for several weeks.
Remove batteries from the instrument if it is not going to be used for more
than a month (refer to Section 14 for the internal memory hold-up time).
The type of cell fitted must be set in the CONFIGURATION menu. By
default this is ALKALINE. Change the setting in the CONFIGURATION
menu (scroll to BATTERY TYPE as described in Section 12.2).
To fit the cells remove the battery compartment cover on the base of the
tympanometer. Fit the cells as indicated inside the battery compartment
and replace the battery compartment cover.
Batteries should only be changed outside the patient
environment. The operator should not touch the
battery connectors and the patient simultaneously.
A battery state indicator is shown in the top right corner of the display
(except when showing test results). This shows the battery state as a
progressively emptying battery. The batteries should be replaced when the
symbol “!”appears next to the battery state indicator, or when advised to
do so, for example at switch-on.
Changing the batteries does not affect the configuration, the contents of the
database, the calibration settings or the results of the last test.
4.2. Operating language
To set the operating language (English, German, French, Spanish,
Portuguese or Italian) use the options within the CONFIGURATION menu
(see Section 12.2).
4.3. Controls and indicators (base unit)
Press the On/Off key momentarily to turn the Otowave 202 on (refer to the
diagram below).
No warm-up time is required, although a short diagnostic routine will run for
a few seconds. During this time the internal pump will operate. To switch
off, again press the On/Off key momentarily.

Page 12 D-0115696-B Otowave 202 Operating Manual
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.
When powered by batteries and not performing a test the Otowave 202 will
switch off automatically after 90 or 180 seconds if no key is pressed (see
Section 12.2 to make this selection).
4.4. Controls and indicators (probe)
4.5. Indicators and system status
The indicators show the status of the system. Typical indications during a
measurement sequence are as follows:
Ear tip
Indicators
Indicator
Function button
Display
Navigation
Keys
On/Off key

D-0115696-B Otowave 202 Operating Manual Page
13
Base Unit
Indicator
(Green)
Base Unit
Indicator
(Yellow)
Probe
Indicator
(Green/Yellow)
Status
Off
Off
Off
Otowave turned off
On
Off
On (Green)
Idle, test completed or test
cancelled
Fast flash
Fast flash
Alternating
(Green/Yellow)
Insert probe or remove
probe (refer to display for
details)
Off
Slow flash
Slow flash
(Yellow)
Ensure probe is held steady
while an ear seal is
obtained
Slow flash
Off
Slow flash
(Green)
Testing - tympanogram
and/or reflex measurement
For a full description of indicators used, messages displayed and possible
error conditions refer to Section 13.
4.6. Probe components
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 removed and cleaned or replaced.
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.
Boss
Probe Tip
Seal
Nose cone
Nut

Page 14 D-0115696-B Otowave 202 Operating Manual
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 (see Section 10).
4.7. Contralateral transducer
This accessory 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 eartip (see Section 5.3).
The contralateral probe tip may be replaced if necessary (e.g. if damaged).
Refer to Section 15 for details of the replacement part. 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.
4.8. Start-up and menu displays
When the Otowave 202 is turned on the start-up screen is shown while
internal tests are performed and the pump is initialised. When the start-up
sequence is complete the MAIN MENU is displayed:
Ear tip
Probe
Tip

D-0115696-B Otowave 202 Operating Manual Page
15
MAIN MENU
NEW TEST
CONFIGURATION
VIEW THE LAST TEST
Select
Use the navigation keys to scroll through and select menu options. The
menus are summarised in Section 12.
4.9. Initial settings
Use the CONFIGURATION options (see Section 12.2) to select the
following options as required:
display contrast for ease of viewing
correct local date and time
date format for display and printouts etc (DD/MM/YY or
MM/DD/YY)
correct battery type (if used)
power-off delay under battery power when no key is pressed (90 or
180 seconds)
correct printer type (if used)
5. Taking Measurements
Ensure that the appropriate settings have been made
before carrying out a test. See below and the
CONFIGURATION options in Section 12.2
To view the test settings ensure that the MAIN MENU is displayed and then
press and hold the function button on the probe to display the TEST
SETTINGS screen as shown below.

Page 16 D-0115696-B Otowave 202 Operating Manual
TEST SETTINGS
Probe: 226 Hz
Reflexes: Ipsi+Contra
500 1k 2k 4k Max dB
I: 85/5
C: 85/5
Probe #: 12345
Contra #: 6789
This indicates the probe frequency being used, the reflex source selected,
and the selected frequencies, maximum level and step size of the reflex
stimulus. Also displayed are the serial numbers of the probe and the
contralateral transducer.
In the above example the probe frequency is 226Hz, all frequencies have
been selected for both the ipsilateral and contralateral reflex stimuli, and
the maximum level for both reflex stimuli is 85dBSPL with a step size of
5dB between the three preceding lower levels of stimulus.
5.1. Prior to testing and ambient conditions
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.
Tympanometric and reflex testing should always be performed in quiet
conditions.
5.2. Test arrangement
The schematic diagram below shows a typical example of the use of
audiometric test equipment. The Otowave tympanometer is located on the
desk of the operator as shown, and the operator is positioned (seated or
standing) so as to be able to initiate a test by using the tympanometer
controls and then apply the ipsilateral probe to the patient’s ear