AmpliVox Otowave 102 User manual

Otowave 102
Operating Manual

ABOUT THIS MANUAL
READ THIS OPERATING MANUAL BEFORE ATTEMPTING TO USE THE
INSTRUMENT.
This manual is valid for the Otowave 102 (applies from firmware version
1.71.C onwards –please refer to SYSTEM INFORMATION screen).
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.

OM001-16 Otowave 102 Operating Manual Page 1
CONTENTS
1. Introduction......................................................................................3
1.1. Intended applications.........................................................................3
1.2. Features ............................................................................................3
1.3. Unpacking..........................................................................................3
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
3. Principles of Operation...................................................................6
3.1. Compliance measurement.................................................................6
3.2. Tympanogram ...................................................................................6
3.3. Stapedial reflex measurement...........................................................7
4. Using the Otowave..........................................................................7
4.1. Installing & replacing batteries ..........................................................7
4.2. Operating language...........................................................................8
4.3. Controls and indicators......................................................................8
4.4. The probe........................................................................................10
4.5. Start-up and menu displays.............................................................10
4.6. Initial settings...................................................................................11
5. Taking measurements...................................................................11
5.1. Prior to testing and Ambient conditions...........................................11
5.2. Ear tip(s)..........................................................................................12
5.3. Performing a test.............................................................................12
5.4. Ear seal check.................................................................................17
5.5. Reflex options..................................................................................18
5.6. Error messages...............................................................................18
6. Saving Results in the Internal Database.....................................19
6.1. Data entry........................................................................................19
6.2. Database full....................................................................................20
7. IrDA Communications...................................................................20

Page 2 OM001-16 Otowave 102 Operating Manual
8. Transferring the Results...............................................................21
8.1. Sending the results to a printer........................................................21
8.2. Data transfer to NOAH or TympView ..............................................22
9. Data Management..........................................................................23
9.1. List records......................................................................................24
9.2. Delete records.................................................................................25
9.3. Print records....................................................................................25
9.4. Send records to a computer............................................................25
10. Performing Daily Checks..............................................................25
11. Routine Maintenance ....................................................................26
11.1. Cleaning the Otowave.....................................................................26
11.2. Ear tip and Probe.............................................................................26
11.3. Calibration and Repair of the Instrument.........................................27
12. Menu Summary..............................................................................27
12.1. Main menu.......................................................................................27
12.2. Sub-Menu selections.......................................................................28
13. Error Messages & Fault Conditions.............................................30
14. Technical Specification.................................................................32
14.1. Performance....................................................................................32
14.2. Equipment classification..................................................................35
14.3. Symbols...........................................................................................35
15. Ordering Consumables and Accessories...................................36
16. Disposal Information.....................................................................37
17. EMC Guidance & Manufacturer’s Declaration ............................38
18. Use with Non-medical Electrical Equipment...............................44

OM001-16 Otowave 102 Operating Manual Page 3
1. Introduction
Thank you for purchasing an Amplivox Otowave 102, a hand-held, portable
tympanometer that will give many years of reliable service if treated with
care. This operating manual covers product variants 102-1 & 102-4.
1.1. Intended applications
The Otowave 102 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 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
measures ipsilateral reflexes and, when selected, reflex measurement is
automatically carried out after a tympanogram is taken.
1.2. Features
Automatic measurement of ear canal volume, tympanic
compliance peak, placement of the peak and the gradient
Automatic detection of stapedial reflexes
Up to 30, dual-ear patient tests can be stored in non-volatile
memory
Configurable settings for 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 a computer via an infrared IrDA link for storage
viewing & printing using either the Amplivox “TympView” software
or the NOAH application
English, French or German operating languages (user-selectable)
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 your instrument or
Amplivox if you purchased direct.
Please retain the original shipping carton and packaging to transport the
tympanometer for annual calibration or repair.

Page 4 OM001-16 Otowave 102 Operating Manual
1.4. Standard contents
Otowave 102 Tympanometer 4 in 1 test cavity assembly
4 x 1.5V ‘AA’ Batteries Carrying case
Set of disposable ear-tips Calibration certificate
Operating manual & TympView Warranty card
NOAH impedance module
1.5. Optional accessories
Additional sets of ear tips Additional probe tip
Portable thermal printer Infra-red USB Adapter
Additional rolls of thermal printer paper
Note: If the thermal printer has been purchased it should be charged for a
minimum of 15 hours before being used. Refer to the printer instructions for
further details.
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.
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 ear tips is
dependent upon conditions of use. These parts are
only guaranteed against faulty materials or
manufacture.

OM001-16 Otowave 102 Operating Manual Page 5
2. Important Safety Instructions
The Otowave 102 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
The tympanometer is for indoor use only and should be used only as
described in this manual.
Refer to the precautions specified in Section 4.1 regarding the use of
batteries.
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.
Never insert the probe into a patient’s ear canal without a suitable ear tip
fitted to the probe.
Use only the recommended disposable ear tips (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.

Page 6 OM001-16 Otowave 102 Operating Manual
As with all instruments of this nature the measurements taken will be
influenced by significant changes in altitude & pressure. The Otowave 102
tympanometer must be re-calibrated at the intended operating elevation if it
is to be used at elevations greater than 1000m 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
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 unavoidable the
instrument should be observed to verify normal operation.
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. Compliance measurement
The Otowave 102 measures the compliance of the tympanic membrane
and middle ear by playing a continuous 226Hz tone into the ear canal at a
level calibrated to give 85dB SPL into a 2ml cavity. The sound level this
produces in the ear canal is measured using a microphone and the
compliance calculated from the result. In line with normal audiometric
practice compliance is displayed as an equivalent volume of air in ml.
3.2. Tympanogram
To record the tympanogram the compliance is measured while the air
pressure in the ear canal is varied from +200daPa to -400daPa by means
of a small pump. The compliance peaks when the air pressure is the same

OM001-16 Otowave 102 Operating Manual Page 7
on both sides of the tympanic membrane. The changing compliance with
pressure is displayed as a graph.
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
compliance 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 compliance exceeds a predetermined threshold this constitutes a reflex
and the change in compliance 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 compliance, so reflex measurements
are taken after the tympanogram is measured when the peak compliance
pressure has been established.
The Otowave model 102-1 measures stapedial reflex at 1000Hz, while the
model 102-4 measures at 500Hz, 1000Hz, 2000Hz and 4000Hz. 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 5.5).
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 102 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.
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.

Page 8 OM001-16 Otowave 102 Operating Manual
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.
Note that local regulations are likely to cover disposal of used batteries.
4.2. Operating language
To set the operating language (English, French or German) use the options
within the CONFIGURATION menu (see Section 12.2).
4.3. Controls and indicators
Press the On/Off key momentarily to turn the Otowave on or off (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.
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.

OM001-16 Otowave 102 Operating Manual Page 9
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 not performing a test the Otowave 102 will switch off automatically
after 90 or 180 seconds if no key is pressed (see Section 12.2 to make this
selection).
The indicators show the status of the system. Typical indications during a
measurement sequence are as follows:
Green
Indicator
Yellow
Indicator
Status
Off
Off
Otowave turned off
On
Off
Idle, test completed or test cancelled
Off
Slow flash
Ensure probe is held steady while an
ear seal is obtained
Slow flash
Off
Testing - tympanogram and/or reflex
measurement
For a full description of indicators used, messages displayed and possible
error conditions refer to Section 13.
Ear tip
Probe
Display
Navigation keys
On/off key
Indicators

Page 10 OM001-16 Otowave 102 Operating Manual
4.4. The probe
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 body of the instrument.
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).
4.5. Start-up and menu displays
When the Otowave 102 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:
Nut
Boss
Seal
Probe Tip
Nose Cone

OM001-16 Otowave 102 Operating Manual Page 11
MAIN MENU
NEW TEST
VIEW THE LAST TEST
DAILY CHECK
Select
Use the navigation keys to scroll through and select menu options. The
menus are summarised in Section 12.
4.6. 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 (DD/MM/YY or MM/DD/YY)
correct battery type
power-off delay (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
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 a quiet
room or in an acoustic booth.

Page 12 OM001-16 Otowave 102 Operating Manual
5.2. Ear tip(s)
These must be selected and fitted by a practitioner qualified to perform
tympanometric tests.
The probe tip must be fitted with a new ear tip before it
is presented to a patient’s ear canal. The ear tip must
be fitted completely to the probe tip and must not
occlude any of the four holes in the probe tip. The ear
tip size is chosen to suit the patient’s ear and provide
a comfortable pressure seal.
Refer to Sections 2.1 and 11.2 regarding these single-
use parts.
5.3. Performing a test
Having selected the required test settings a typical tympanogram
measurement and reflex tests are carried out as follows.
From the MAIN MENU select NEW TEST:
MAIN MENU
NEW TEST
VIEW THE LAST TEST
DAILY CHECK
Select
Select the ear(s) required for test:
SELECT EAR
BOTH
LEFT
RIGHT
Back  Select

OM001-16 Otowave 102 Operating Manual Page 13
The message “Deleting last test” will be displayed momentarily followed by
a message to insert the probe into the ear to be tested:
TESTING LEFT EAR
INSERT PROBE
Cancel
Present the ear tip to the ear and obtain a seal. If a good seal has been
detected the following sequence of messages will be seen
TESTING LEFT EAR
Equalising Pressure
Cancel
TESTING LEFT EAR
Pressure Settling
Cancel
Press ◄ at any time to cancel the test and return to the ear selection
menu.
TESTING LEFT EAR
Seal Obtained 
Taking Tympanogram
Cancel

Page 14 OM001-16 Otowave 102 Operating Manual
Once an adequate seal is detected the tympanogram measurement is
made. This takes about 3 seconds. It is important not to move the probe
and to ask the patient to remain very still during the test.
When the tympanogram is complete the instrument will perform the reflex
test(s), if selected. By default this test is only performed if a peak is found in
the tympanogram. This and other reflex test options may be changed in the
CONFIGURATION menu, see Sections 12.2 and 5.5.
Before starting the reflex test the ear canal pressure will be set to the value
that gave the peak compliance during the tympanogram test. The
instrument will then step through the tone frequencies and levels set in the
CONFIGURATION menu searching for a reflex response.
TESTING LEFT EAR
Seeking Reflex
1000 Hz 80 dB
Cancel
The display changes to show the frequency and level being used, starting
with the lowest frequency and level selected.
When the measurement is complete the indicator on the instrument
changes from flashing green to steady green. The display confirms that the
test has been completed along with the instruction WITHDRAW PROBE.
Remove the ear tip from the patient and after a short period the
tympanogram will be displayed.

OM001-16 Otowave 102 Operating Manual Page 15
The display shows:
The peak compliance, in ml (Pk)
The pressure which gave the peak compliance in daPa
The Gradient, in daPa (Gr)
The Ear Canal Volume (ECV) in ml measured at 200 daPa.
A plot of compliance against pressure.
Review the tympanogram to ensure that the peak compliance point
selected by the Otowave is suitable. If required it is possible to select an
alternative peak using the ▲ and ▼ keys. The figures displayed will
change to reflect the peak selected, and will be saved with the
tympanogram.
To repeat the test, press ◄.
When satisfied with the tympanogram press ►.
If reflex test(s) were carried out these results will now be displayed:
The display shows:
The frequency and level of the reflex stimulus
“PASS” if a reflex was found, else “NR” (No Response)
A plot of compliance against time
If the reflex test was performed at more than one frequency use the ▲and
▼keys to view the results for the other frequencies.
If the Otowave 102 was set to test for a reflex at all levels of the stimulus
(see Reflex autostop in Section 5.5) press ► to view an additional display
following the reflex graphs. This shows a summary of the levels and
frequencies at which a reflex was detected. The dash symbol “-” is shown if
a reflex tone was not presented at the level indicated.

Page 16 OM001-16 Otowave 102 Operating Manual
REFLEX SUMMARY
dB
100 X-
90 X
80 X
70 XXX
Hz 500 1k 2k 4k
Press ◄ to return and view the tympanogram, reflex results or to repeat the
test. When satisfied with the results press ►.
The message “Saving as last test” will be displayed and the results will be
saved in the “last test” memory. The results will remain available until a
new test is started, even if the Otowave is turned off.
If both ears were chosen for test the entire sequence will now be repeated
for the right ear:
TESTING RIGHT EAR
INSERT PROBE
Cancel Skip
Press ► to skip testing of the right ear and display the PROCESS
RESULTS menu. Press ◄ to cancel and return to the ear selection menu.
In both cases the left ear results are retained and may be viewed as the
LAST TEST.
Otherwise insert the probe; the right ear test will then proceed as described
above.
When the selected ears have been tested and the results saved the
PROCESS RESULTS menu will be displayed. This accesses the following
functions:
Print the results
Send the results to a computer
Save the results in the internal database