OM001 15 Otowave 102 Operating Manual

Amplivox Ltd
Otowave 102 Hand Held Tympanometer

Operating Manual
(Applies from serial number 37400 onwards)
Amplivox Ltd
6 Oasis Park
Eynsham
Oxfordshire
OX29 4TP
United Kingdom
Tel: +44 (0)1865 880846

Fax: +44 (0)1865 880426
sales@amplivox.ltd.uk
www.amplivox.ltd.uk
0473
For supply in US only
Caution: Federal Law restricts this device to sale by or on the order of a

licenced medical professional.
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
OM001-15 Otowave 102 Operating Manual Page 1

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
Page 2 OM001-15 Otowave 102 Operating Manual

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.

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.

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.

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

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.

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.

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).
Indicators
Ear tip
Probe
Display
On/Off key
Navigation
Keys
The indicators show the status of the system. Typical indications during a
measurement sequence are as follows:
Green Yellow Status

Indicator Indicator
Off Off Otowave turned off
On Off Idle, test completed or test cancelled
Ensure probe is held steady while an
Off Slow flash
ear seal is obtained
Testing - tympanogram and/or reflex
Slow flash Off
measurement
For a full description of indicators used, messages displayed and possible

error conditions refer to Section 13.

4.4. The probe
Nut
Boss
Probe Tip
Seal Nose Cone
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:

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.

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

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

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.

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.

REFLEX SUMMARY
dB
100   X -
90  X  
80 X   
70 X  X X
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

 Review the results as described above
 Return to the main menu
See Sections 6 to 8 for more information on these options.
The results of the last test performed remain available even if the Otowave
has been turned off. To view these results select VIEW THE LAST TEST
from the main menu. After selecting the required ear the tympanogram will
be displayed. It will then be possible to view the results and select the
PROCESS RESULTS menu as if the test had just been completed.
Results of the last test will be erased as soon as a new

test is started. Test results should be saved to the
Otowave’s database, printed or sent to a computer to
ensure that data is not lost.
5.4. Ear seal check

The type of ear seal check employed at the start of a test can be set in the
CONFIGURATION menu (Section 12.2). The default QUICK option is
adequate for most tests, although it may not always be possible to
generate the extremes of pressure with this setting.
However if difficulty is experienced in using the ear tips to create a seal the
alternative THOROUGH option may be helpful. This checks that a range of
pressures will be available before starting a test by means of a visual
indication of the quality of the seal:
TESTING LEFT EAR
Obtaining ear seal
Low :
High :
Cancel
The number of bars shown indicates the robustness of the seal. The probe
should be adjusted in the ear until two or more bars are shown for Low &
High.

5.5. Reflex options
The CONFIGURATION options (Section 12.2) may be used to make the

following settings for the reflex test conditions. Refer also to Section 3.3.
Reflex selection
Use the ▲ and ▼ keys to choose the circumstances when a reflex
measurement is to be made (always, never, only if a compliance peak is
found, or only after confirmation is made at the start of the test sequence).
In cases where a compliance peak has not been established a pressure of
0daPa is used. Press the ► key to confirm the selection or the ◄ key to
cancel.
Reflex levels
Use the ▲ and ▼ keys to choose the maximum level of reflex stimulus to
apply and the step size between the levels of the preceding stimuli. The
maximum level of stimulus may be set between 85dBHL & 100dBHL. Press
the ► key to confirm the selection or the ◄ key to cancel.
Reflex frequencies Otowave 102-4 only
Use the ▲ and ▼ keys to choose between 1000Hz only or 500Hz, 1000Hz,
2000Hz & 4000Hz for the frequencies at which the reflex stimulus is to be
applied. Press the ► key to confirm the selection.
Reflex threshold
Use the keys to choose the change in compliance required to signify that a
reflex response has been detected (0.01ml to 0.5ml). The default is 0.03ml.
Reflex autostop
By default the reflex test at each frequency will stop at the lowest level of
stimulus that produces a response. By setting REFLEX AUTO-STOP to NO
the Otowave 102 will test for a reflex at all selected levels. (Note that
100dBHL at 4000Hz is not available).
Reflex filter
Use the keys to choose either 2Hz or 1.5Hz. The default of 2Hz is suitable
for most circumstances. However if a smoother reflex plot is required for
better interpretation 1.5Hz may be chosen.
5.6. Error messages

The following error messages may be seen during the test sequence.

Indicator
Message Displayed Likely Cause(s)
Status
WITHDRAW Yellow The probe has been moved during
PROBE Flashing measurement. Re-insert the probe to
repeat the test.
Volume outside Yellow The ear canal volume is above the
range Flashing 5ml. This message can also occur
WITHDRAW when the probe is not properly inserted
PROBE into the ear.
Blocked ear Green The ear canal volume is below 0.1ml.
WITHDRAW Flashing Check that the probe is not blocked
PROBE and correctly inserted into the ear.
INSERT PROBE Yellow The seal was lost. Reinsert the probe
Flashing to repeat the test.
6. Saving Results in the Internal Database
Up to 30 tests can be saved in the Otowave 102 internal database.

To save the results of a test select SAVE RESULTS from the PROCESS
RESULTS menu that is displayed on completion of a test. This option can
also be accessed by selecting VIEW THE LAST TEST from the main menu
and scrolling through the results using the ► key as long as the test results
have not already been saved or deleted (e.g. by starting and then aborting
a new test).
A three character identifier is used for the record. This is also used as the
reference for the patient’s name on the printed record and for data
transferred to a computer. The identifier would typically be the patient’s
initials, and as the tympanometer uses a combination of this identifier and
the date/time of a test to refer to stored records this same identifier may be
used for different tests for the same patient.
6.1. Data entry
PATIENT INITIALS
_____
ABCDEFGHIJKLM
NOPQRSTUVWXYZ
-01233456789
Hold to enter / cancel

To enter the identifier:
Use the ▲, ▼, ◄ and ► keys to select a character.
Press and hold the ► key to enter the selected character.
Press and hold the ◄ key to delete the last character.
To save the test results:
Enter all three characters for the identifier.
Press and hold the ► key to save the record.
To cancel saving the last test:
Delete any characters that have been entered.
Press and hold the ◄ key.
6.2. Database full
A warning will be displayed if the database is full when attempting to save a

test:
MEMORY FULL!
MANAGE DATA
DELETE OLDEST
Cancel
Selecting MANAGE DATA will display the DATA MANAGEMENT menu
(Section 9) which provides options for printing or transferring data to a
computer prior to deleting records to make space for the new test.
DELETE OLDEST will overwrite the oldest record in memory with the
results being stored.
Cancel will return to the previous menu.
7. IrDA Communications
Please refer to Section 18 for important information

regarding the connection of non-medical electrical
equipment to medical electrical equipment

The Otowave 102 can send test results to a designated printer or a
suitably-equipped computer via an infra-red link.
If the computer does not have an infra-red port a suitable infra-red adapter
will be required. The Actysis ACT-IR2000U USB adapter is specified for
and has been tested for use with the Otowave 102. This adapter may be
purchased from Amplivox (see Section 15) and only this device should be
used for this purpose.
The Otowave sends data through a small window on the right of the probe.
For a printer the data is received through a window in the front of the
printer; for a computer the data is received through a window located either
on the case or on the plug-in adapter if this is used.
The environment in which the Otowave is used can affect the data transfer
process. The following are recommendations but may need to be modified
depending on the environment.
 The two communication windows should be in line and pointing directly

at each other, 10-20cm apart
 Both units must be out of direct sunlight for optimum communication
 For transferring data to a printer ensure that no computer or printer
other than the one to be used is within range
 Similarly, for transferring data to a computer ensure that no other IrDA
device is within range
 The infra-red link must not be broken once a connection between the
printer/computer and the Otowave has been established
 If the printer/computer or Otowave are moved, or an object between
them breaks the link, the data may become corrupted or the Otowave
may not respond to the controls until the data transfer process has
timed-out (this could take 30 to 40 seconds); this may also occur if the
printer batteries are discharged while attempting to print
Once the data transfer process has timed-out the resulting error message
can be cleared and the data re-sent; if the data is still corrupted select
Cancel on the Otowave and then send the data again.
8. Transferring the Results
8.1. Sending the results to a printer

Two designated thermal printers (the Able AP1300 or the Martel MCP8830)
are available as options and only these printers should be used. Printers

supplied with the Otowave 102 are correctly configured for communication
but it is important to ensure that the correct printer is selected (use the
MENU options described in Section 12.2 to make this selection).
If the Martel MCP8830 does not communicate properly (i.e. will not print)
please check that the Option2 setting (for IrDA communications) is set to 2
(9600 baud)
If the Martel MCP8830 printer is also to be used with an Amplivox
audiometer it may be necessary to ensure that the Option 4 setting (for
RS232 Baud Rate) is set to 4 (2400 baud). Refer to the documentation
supplied with the printer.
The Able printer has no user-settable configuration options.
Before attempting to print ensure the printer is fully charged, switched on,
loaded with paper and ready to print.
To print the results of the last test select SEND TO PRINTER from the
PROCESS RESULTS menu on completion of the test. (Similar facilities for
printing are available from the VIEW THE LAST TEST and DATA
MANAGEMENT options in the MAIN MENU.)
Press ◄ to cancel printing.
The three character identifier for the record (see Section 6) is printed in the
“Name” field followed by the Otowave graphical displays, the analysis and
the results. The name of the hospital, the department, and the calibration
dates for the instrument may also be printed if required (see Section 12.2).
There is space for additional details to be handwritten by the clinician
(patient name/age, operator & comments).
Thermal paper printouts can fade with exposure to light or heat. Consider
transferring the data to a computer for permanent storage.
8.2. Data transfer to NOAH or TympView
To transfer test results stored within the tympanometer to a NOAH

database the Amplivox NOAH Impedance module must be installed on to a
computer. Alternatively, Amplivox TympView allows data to be transferred
to a computer and subsequently viewed, annotated & printed. This software
is supplied on a CD which includes this operating manual.
Refer to the installation & operating instructions provided with the NOAH
Impedance Module or TympView for further details.

If communication between the Otowave 102 and the computer cannot be
established the message “Device not found” is displayed. The following
points should be checked:
 Ensure the environment is suitable (see Section 7)

 The computer has its IrDA software properly installed and the
interface enabled
 If the computer has been in “Hibernate” mode the IrDA
interface is not always re-enabled; try restarting the computer
 The IrDA adapter on the computer is compatible with the
Otowave
 Turn the Otowave off and on again before trying to send the
data again
If communication is lost while sending the data the message “Link was
unreliable” will be displayed. Press ◄ to cancel sending the data and start
the operation again.
If any other messages are displayed while sending data, turn the Otowave
off and then on again and try re-sending the data. If the problem persists
contact an Amplivox service centre.
9. Data Management
Records stored in the database of the Otowave 102 can be listed, viewed,
deleted, printed or sent to a computer using the DATA MANAGEMENT
option of the main menu:
DATA MANAGEMENT
LIST RECORDS
DELETE RECORDS
PRINT RECORDS
Back  Select
Scroll down to see the remaining choice:

DATA MANAGEMENT
DELETE RECORDS
PRINT RECORDS
SEND RECORDS TO PC
Back  Select
If it is required to work with the record of an individual test, select LIST
RECORDS. All other options operate on groups of records.
9.1. List records

LIST RECORDS shows the stored tests, 6 at a time, most recent first:
Records Stored: 6/30

ABC 02/01/06 14:15 2
DEF 31/12/10 09:43 L
1SF 20/12/05 11:54 R
MJL 17/10/05 15:48 2
AS- 17/10/05 14:22 L
BBC 12/10/05 10:24 2
Back  Select
Each entry shows:
 Three-letter patient identifier entered when the test was stored;
 Date and time of the test
 Whether the test has been printed ( )
 Whether the test has been sent to a computer ( )
 Whether the test is for the Left (L), Right (R) or both (2) ears
Press ▲ or ▼ to scroll through the records
Press ► to select the highlighted record
Press ◄ to return to the previous menu
When a record is selected the PROCESS RECORD menu will be
displayed. This accesses the following functions:
 View the selected record

 Print the selected record
 Send the selected record to a computer
 Delete the selected record

See Sections 7 and 8 for further information on printing a record or sending
it to a computer.
9.2. Delete records

DELETE RECORDS allows a group of records to be deleted. It is possible
to delete all records, all records that have been printed or all records that
have been sent to a computer.
Confirmation of the deletion is required.
9.3. Print records

PRINT RECORDS allows a group of records to be sent to the printer. It is
possible to print all stored records or just those records that have not
already been printed. Refer to Section 8.1 for more general information. If
printing the entire database it is recommended that a full roll of paper is
loaded into the printer.
9.4. Send records to a computer

SEND RECORDS TO PC allows a group of records to be sent to a
computer. It is possible to send all stored records or just those records that
have not already been sent. Refer to Section 8.2 for more general
information.
10. Performing Daily Checks
The operation of the Otowave 102 should be checked daily using the 4 in 1
test cavity assembly supplied with the instrument.
Select the DAILY CHECK option in the main menu:
DAILY CHECK
Volume: Open
Cancel
Wait until “Open” is displayed.

Insert the probe, without an ear tip, into the hole at the 2ml end of the test
cavity. Make sure that the probe is pushed fully home and is held tight
against the stop. The probe must be square to the end of the test cavity.
The display should show the volume of the test cavity to within ± 0.1ml.
DAILY CHECK
Volume: 2.0 ml
Cancel
Remove the probe and repeat the test with the three remaining test
cavities. The display should show the volume of the 0.2ml and 0.5ml test
cavities to within ± 0.1ml. The 5.0ml test cavity should be within ± 0.25ml.
When the checks have been completed press ◄ to return to main menu.
11. Routine Maintenance
11.1. Cleaning the Otowave
The Otowave is a precision instrument. Handle it carefully in order to

ensure its continued accuracy and service. Before cleaning the instrument
remove the batteries. Use a soft damp cloth and mild detergent to clean
the instrument panel and case. Ensure no moisture enters the instrument.
11.2. Ear tip and Probe
Ear tips should be replaced after a single use.

The probe tip and its associated seal are disposable devices.
The probe tip should be checked before each ear insertion to ensure it is
undamaged and that none of the tubes through it are blocked. It should be
replaced if necessary.
The seal should be replaced when the probe tip is replaced, if it shows
signs of wear, or if a pressure leak is suspected.
Refer to Section 4.4 for illustrations of these components.

Handle the probe and accessories with care. Do not
allow moisture, condensation, fluids or debris to enter
the probe.
11.3. Calibration and Repair of the Instrument
Amplivox recommends that the Otowave is calibrated annually. Please

contact Amplivox for details.
If the instrument is to be used at elevations above that specified in Section
2.1 re-calibration must be undertaken at the intended operating elevation.
The instrument should be returned to the manufacturer

for service & repair. There are no user-serviceable
parts within it.
Please use the original shipping carton and packaging to transport the
instrument. Place the instrument in a plastic bag before packing to prevent
dirt and dust getting into the probe. Do not return the batteries with the
instrument.
12. Menu Summary

Default values are shown in bold.
12.1. Main menu

Menu Sub-menu
MAIN MENU NEW TEST
VIEW THE LAST TEST
DAILY CHECK
DATA MANAGEMENT
CONFIGURATION
SYSTEM INFORMATION

12.2. Sub-Menu selections
Sub-menu Option Choices / Description
NEW TEST SELECT EAR Choose which ear(s) to test and
start the test. A tympanogram is
taken followed by reflex
measurements, if selected. On-
screen messages & indicators show
progress. Graphical displays are
shown automatically at the end.
VIEW THE LAST SELECT EAR Recalls the last stored test for the
TEST selected ear. Shows the
tympanogram and reflex responses,
if available. Also allows the last test
to be printed, sent to a computer or
stored in the internal database
DAILY CHECK Shows the volume in ml measured
by the probe.
DATA LIST RECORDS Lists the test results stored in the
MANAGEMENT internal database. Allows individual
records to be viewed, printed, sent
to a computer or deleted.
DELETE Delete stored records. Select:
RECORDS
ALL PRINTED RECORDS – Delete
all records that have been printed.
ALL SENT RECORDS – Delete all

records that have been sent to a
computer.
ALL RECORDS – Delete all records

PRINT Print stored records. Select:
RECORDS
UNPRINTED RECORDS – Print all
records not previously printed.
ALL RECORDS – Print all records

SEND Transfer records to a computer.
RECORDS TO Select:
PC
UNSENT RECORDS – Send all
records not previously sent.
ALL RECORDS – Send all records

CONFIGURATION TODAY’S DATE Set the internal clock date and time;
use the ◄ & ► keys to select a
field and the ▲ & ▼ keys to adjust
the value.
REFLEX Select when reflexes will be
SELECTION measured (see Section 5.5):
ALWAYS MEASURE
NEVER MEASURE
ONLY IF PEAK FOUND
PROMPT TO MEASURE
REFLEX See Section 5.5. Set to 100dB (with
LEVELS 5dB or 10dB steps) or 95dB, 90dB
or 85dB with 5dB steps.
REFLEX See Section 5.5. Default 500, 1000,
FREQUENCIES 2000 and 4000 Hz (for 102-4)
REFLEX See Section 5.5. Default 0.03 ml
THRESHOLD
REFLEX AUTO- See Section 5.5. Default YES
STOP
REFLEX FILTER See Section 5.5. Default 2 Hz
PRINTER Select Able AP1300 or Martel
MCP8830
BATTERY TYPE Select Alkaline or NiMH (This
effects the battery state display and
low battery warning).
POWER-OFF The time after which the unit turns
DELAY off automatically if no key is
pressed. Select 90 or 180 seconds
LCD CONTRAST Change the display contrast. 0 – 15.
Default 7.
EAR SEAL Select QUICK or THOROUGH
CHECK See Section 5.4.
REPORT CAL. Select PRINT CAL. DATES or
DATES HIDE CAL.DATES

SET DATE Select DD/MM/YY or MM/DD/YY
FORMAT (used for display and printouts)
HOSPITAL Allows the Hospital name to be
NAME entered (this will appear at the top
of the print out). See Section 6.1 for
the data entry method; then position
the cursor on # symbol and hold ►
to confirm or ◄ to cancel.
DEPARTMENT Allows the Department name to be
entered (this will appear at the top
of the print out). See Section 6.1 for
the data entry method; then position
the cursor on # symbol and hold ►
to confirm or ◄ to cancel.
RELOAD Select YES to reset the options
DEFAULTS above to their default values.
SELECT Select ENGLISH, GERMAN or
LANGUAGE FRENCH for operating language
SYSTEM Shows: Battery voltage (Battery)
INFORMATION Software version (Version)
Date calibrated (Last Cal)
Next calibration date (Next
Cal)
Instrument serial number
(Serial No)
Current date and time
13. Error Messages & Fault Conditions

If a fault condition cannot be cleared, the operator is
cautioned against repeatedly starting the instrument.
In some fault conditions the internal pump may
progressively advance towards the end of its travel in
an attempt to clear the fault. If the end of travel is
reached in such conditions the instrument may lock up
and become un-usable.
If difficulties resolving fault conditions occur the

equipment distributor (or Amplivox if purchased
directly) should be consulted.

Message Meaning / Action
PROBE NOT CLEAR Examine the probe tip for
Please ensure the probe is not blocked blockages. If necessary
or obstructed remove it and clean or replace
PUMP ERROR it, see Section 4.4. If the
Pump error. RESTART THE UNIT. If problem persists, contact your
problem persists, contact Amplivox Amplivox service centre.
WARNING! CALIBRATION EXPIRED. The current date is later than
Recalibration needed before further tests the next calibration date. Check
are performed that the clock is set to the
correct date. If so, arrange for
the instrument to be
recalibrated. Tests can still be
performed.
“WARNING! BATTERIES LOW. Replace the batteries
Replace batteries before performing tests immediately, see Section 4.1
Powering down The Otowave is turning off
because the batteries are
discharged. Replace the
batteries.
PUMP ERROR. Cannot determine pump Pump fault. If the fault persists
direction. If problem persists, contact contact your Amplivox service
Amplivox centre.
PUMP ERROR. If problem persists, Contact your Amplivox service
contact Amplivox centre.
Measurement timed out This occurs when the ear seal
check is set to THOROUGH if:
(i) The pump failed to achieve
the starting pressure within 4
seconds. This may be because
the probe was moved in the
ear.
(ii) The pressure failed to reach
-400 daPa within 12 seconds.
Retry the test. If the problem
persists, contact your Amplivox
service centre.
“WARNING! DEVICE UNCALIBRATED. This message should never
One or more default values require normally be seen. If it persists
recalibration before further tests are contact your Amplivox service
performed centre.

WARNING! DEFAULTS RELOADED. This message should never be
Default configuration settings reloaded. seen. Check all the
Check before making new tests CONFIGURATION settings
before taking measurements. If
the error persists, contact your
Amplivox service centre.
ERROR The Otowave was unable to
Transfer failed send data to the computer. See
No device found or Link was unreliable Section 8 for details.
WITHDRAW PROBE The probe has been moved
during measurement. Re-insert
the probe to repeat the test.
Volume outside range The ear canal volume is above
WITHDRAW PROBE the 5ml. This message also
occurs when the probe is not
properly inserted into the ear.
Blocked probe The ear canal volume is below
WITHDRAW PROBE 0.1ml. This message also
occurs when the probe tip is
blocked. Check that the probe
is correctly inserted into the
ear. Check that the probe is not
blocked.
INSERT PROBE The seal was lost. Reinsert the
probe to repeat the test.
14. Technical Specification
14.1. Performance
Tympanometry
Instrument type Meatus compensated tympanometer
Analysis performed Compliance peak level (in ml) &
pressure; Gradient (in daPa);
Ear Canal Volume (ECV) @ 200 daPa
Probe tone levels and accuracy 226Hz +/- 2%; 85dB SPL +/-2dB over
range 0.2ml to 5ml
Pressure levels and accuracy +200daPa to -400daPa +/-10daPa or
+/-10% (whichever is larger) over range
Ear volume measurement range 0.2ml to 5ml +/- 0.1ml or +/-5%
and accuracy (whichever is larger) over entire range

Sweep speed Typically 200-300daPa/sec; dependent
on ear/cavity volume
Pressure limits (safety cutout) +600 to -800 daPa
Number of samples stored 100 per tympanogram
Reflex measurements
Measurement mode Ipsilateral
Reflex tone levels and accuracy 102-1: 1kHz (+/-2%)
102-4: 500Hz,1kHz,2kHz,4kHz (+/-2%)
(referenced to 2ml calibration Configurable over range 70dB
volume - compensates for to100dBHL +/-3dB (4kHz restricted to
measured ear volume) 95dBHL)
Number of reflex levels (see Four: 100dB with 5dB or 10 dB steps;
Section 3.3) 95dB, 90dB or 85dB with 5 dB steps
Reflex analysis Reflex pass/fail at each level tested;
maximum amplitude of each reflex;
nominal pressure used for the reflex
test (computer display only)
Pressure used for reflex Pressure at tympanogram peak, or at
measurement 0daPa (if no peak found)
Reflex stimulus control Stimulus presented at all levels, or
stimulus ceases when a reflex is found
Reflex detection threshold and 0.01ml to 0.5ml +/-0.01ml (configurable
accuracy in 0.01ml steps)
Reflex tone duration 0.6 seconds
Number of records stored in 30
Patient Database
Data storage Any recording can be stored once the
tympanogram is viewed. Patient Initials
(A-Z, 0-9, “-“) must be entered before
storage.
Data held Patient Initials, Tympanogram and
Reflex graphs and analysis for Left Ear
and/or Right Ear, Time and Date of
recording, which ears were tested,
whether or not the record has been
printed and/or sent to a computer,
parameters used for analysis, 128 bit
Globally Unique Identifier (GUID)
Display mode Records listed in reverse chronological
order (latest first), with indication of data
stored as described above

Real Time Clock
Time stamps Time and date stamp applied to all
recordings, and to the last calibration
date
Backup power supply > 30 days without main batteries fitted
Languages
Operating Languages English, German or French
Printing
Supported printer Martel MCP8830 or Able AP1300
Interface Infra-red, IrDA hardware, 9600 baud
Information printed Tympanogram, Tympanogram analysis
parameters, Reflex graphs, Reflex
analysis parameters, Serial Number of
device, Last and Next Due Calibration
dates; space for patient & clinician’s
details to be entered.
Serial Interface to computer
Interface OBEX (Object Exchange) service
running on top of IrDA stack. Auto-
selects between 9600-115200 baud.
Information sent Patient header, left and right ear data.
Power Supply
Battery Types 4 AA cells; either Alkaline (1.5V
nominal) or NiMH rechargeable (1.2V
nominal, which must be 2.3 Ah capacity
or greater).
Warm-up period None at room temperature
Number of recordings from one Approx. 200 (Alkaline) or 100 (NiMH)
set of cells
Auto power-off delay 90 or 180 seconds
Idle current 70mA
Current while testing 230mA
Physical
Display 128 x 64 pixels / 8 lines of 21
characters
Dimensions 190mm long x 80mm wide x 40mm high
excluding probe
210mm long including probe
Weight (without batteries) 285 g
Weight (with batteries) 380 g

Environmental
Operating temperature range +15oC to +35oC
Operating humidity range 30% to 90% RH, non-condensing
Operating atmospheric pressure 980 to 1040 mb (see Section 2)
range
Transport and storage -20oC to +70oC
temperature range
Transport and storage humidity 10% to 90% RH, non-condensing
range
Transport and storage 900 to 1100 mb
atmospheric pressure range
Standards conformance
Safety IEC 60601-1(plus UL, CSA & EN
deviations)
EMC IEC 60601-1-2
Performance IEC 60645-5, Type 2 Tympanometer
CE mark To the EU Medical Device Directive
14.2. Equipment classification

Type of protection against electric shock Internally Powered
Degree of protection against electric shock Type BF applied part
Degree of protection against ingress of water Not protected
Mode of operation Continuous operation
Equipment mobility Portable
The Otowave 102 Tympanometer is classified as a Class IIa device under

Annex IX (Section 1) of the EU Medical Devices Directive.
14.3. Symbols
Definition: Refer to instruction manual (mandatory)
Definition: Type BF applied part – an applied part

providing a higher degree of protection against electric
shock than that provided by a Type B applied part,
particularly regarding allowable patient leakage current and
patient auxiliary current.
The applied part is the ear tip.

15. Ordering Consumables and Accessories
To order consumables, additional accessories and to replace detachable

parts that have been damaged, please contact Amplivox for current prices
and delivery charges. The items available are listed below:
Stock No. Description

T527 Probe tip
T518 Seal
T030 4 in 1 test cavity assembly (0.2ml/0.5ml/2.0ml/5.0ml)
T20 Ear tip set
T205 Ear tip Otowave 3-5mm
T206 Ear tip Otowave 4-7mm
T207 Ear tip Otowave 7mm
B132 Carrying case
PT01 Printer Able AP1300
C0103 Thermal printer paper for Able AP1300
A091 Printer Martel MCP8830
C01 Thermal printer paper for Martel MCP8830
T91 ACTiSYS infrared USB adapter
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.

16. Disposal Information
Amplivox Limited is fully compliant with the WEEE (Waste
Electrical and Electronic Equipment) Regulations. Our PRN
(Producer Registration Number) is WEE/GA0116XU and
we are registered with the approved WEEE Compliance
Scheme, B2B Compliance, approval number
WEE/MP3338PT/SCH.
The main purpose of the WEEE Regulations is to

encourage the segregation of waste electrical items from
the general waste stream and into reuse, recovery and
recycling routes.
Therefore for any waste electrical units purchased from Amplivox that
either:
 bear the crossed out wheeled bin symbol with black bar
underneath, or
 have been replaced with new Amplivox products on a like-for-like
basis
please contact our WEEE Compliance Scheme, B2B Compliance, using

the details below. B2B Compliance will be able to provide further
information on how to recycle your waste electrical units and answer any
queries you may have.
B2B Compliance
Tel: +44 (0) 1691 676 124 (Option 2)
Email: operations@b2bcompliance.org.uk

17. EMC Guidance & Manufacturer’s Declaration
Guidance and manufacturer’s declaration – electromagnetic

emissions
The Otowave 102 Tympanometer is intended for use in the
electromagnetic environment specified below. The customer or user of
the Otowave 102 Tympanometer should assure that it is used in such an
environment.
Emissions test
Compliance Electromagnetic
environment – guidance
RF emissions Group 1
The Otowave 102
Tympanometer uses RF
CISPR 11 energy only for its internal
function. Therefore, its RF
emissions are very low and are
not likely to cause interference
in nearby electronic equipment.
RF emissions
Class B The Otowave 102
Tympanometer is suitable for
CISPR 11 use in all establishments,
Harmonic emissions including domestic
Not
establishments and those
applicable
directly connected to the public
IEC 61000-3-2 low-voltage power supply
Voltage network that supplies buildings
Not
fluctuations/flicker used for domestic purposes.
applicable
emissions
IEC 61000-3-3

Guidance and manufacturer’s declaration – electromagnetic immunity
(1)
The Otowave 102 Tympanometer is intended for use in the electromagnetic
environment specified below. The customer or user of the Otowave 102
Tympanometer should assure that it is used in such an environment.
Immunity test IEC 60601 Compliance Electromagnetic
test level level environment –
guidance
Electrostatic ±6 kV contact ±6 kV contact
Floors should be
Discharge (ESD)
wood, concrete or
±8 kV air ±8 kV air ceramic tile. If floors
IEC 61000-4-2 are covered with
synthetic material,
the relative humidity
should be at least
30%
Electrical fast ±2 kV for
Not applicable Not applicable
transient/burst power supply
lines
IEC 61000-4-4
±1 kV for
input/output
lines
Surge ±1 kV
differential
mode
IEC 61000-4-5
±2 kV
common
mode

Immunity test IEC 60601 Compliance Electromagnetic
test level level environment –
guidance
Voltage dips, <5% UT
short (>95% dip in
interruptions and UT) for 0.5
voltage variations cycle
on power supply
input lines 40% UT
(60% dip in
UT) for 5
IEC 61000-4-11
cycles
70% UT
(30% dip in
UT) for 25
cycles
<5% UT
(>95% dip in
UT) for 5 sec
Power frequency
3 A/m 3 A/m Power frequency
(50/60 Hz)
magnetic fields
magnetic field
should be at levels
characteristic of a
IEC 61000-4-8 typical location in a
typical commercial
or hospital
environment.
NOTE UT is the a.c. mains voltage prior to the application of the test level

Guidance and manufacturer’s declaration – electromagnetic immunity (2)
The Otowave 102 Tympanometer is intended for use in the electromagnetic
environment specified below. The customer or user of the Otowave 102
Tympanometer should assure that it is used in such an environment.
Immunity IEC 60601 Compliance Electromagnetic
test test level level environment – guidance
Portable and mobile RF
communications equipment
should be used no closer to
any part of the Otowave 102
Tympanometer, including
cables, than the
recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
Radiated 3 V/m 3 V/m Recommended separation

RF distance
80MHz to
IEC 2.5GHz
d = 1.2√P 80MHz to 800MHz
61000-4-3
d = 2.3√P 800MHz to 2.5GHz
where P is the maximum

output power rating of the
transmitter in Watts (W)
according to the transmitter
manufacturer and d is the
recommended separation
distance in metres (m).
Field strengths from fixed RF

transmitters, as determined
by an electromagnetic site
survey, a should be less than
the compliance level in each
frequency range. b

Guidance and manufacturer’s declaration – electromagnetic immunity (2)
Interference may occur in the
vicinity of equipment marked
with the following symbol:
NOTE 1 At 80MHz and 800MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic

propagation is affected by absorption and reflection from structures, objects
and people.
a Field strengths from fixed transmitters, such as base stations for
radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured
field strength in the location in which the Otowave 102
Tympanometer is used exceeds the applicable RF compliance
level above, the Otowave 102 Tympanometer should be observed
to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or
relocating the Otowave 102 Tympanometer.
b over the frequency range 150 kHz to 80 MHz, field strengths

should be less than 3 V/m.

Recommended separation distances between portable and mobile RF
communications equipment and the Otowave 102 Tympanometer
The Otowave 102 Tympanometer is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The
customer or the user of the Otowave 102 Tympanometer can help prevent
electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the
Otowave 102 Tympanometer as recommended below, according to the
maximum output power of the communications equipment.
Rated Separation distance according to frequency of
maximum transmitter
output power
of transmitter
m
150 kHz to 80 80 MHz to 800 800 MHz to 2.5
W MHz MHz GHz
d = 1.2√P
d = 1.2√P d = 2.3√P
0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in metres (m) can be estimated using
the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in Watts (W) according to
the transmitter manufacturer.
NOTE 1 At 80MHz and 800MHz, the separation distance for the higher
frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects
and people.

18. Use with Non-medical Electrical Equipment
Any person who connects external equipment to signal input, signal output
or other connectors has created a medical electrical system and is
therefore responsible for the system complying with the requirements of
clause 16 of IEC 60601-1:2005 (General requirements for basic safety and
essential performance).
If connections are made to standard equipment such as printers and

computers, special precautions must be taken in order to maintain medical
safety. The following notes are provided for guidance in making such
connections to ensure that the general requirements of clause 16 of IEC
60601-1:2005 are met.
The Otowave 102 tympanometer uses an industry-standard infra-red

means of communication (an IrDA port - as described in Section 7) in order
to reduce any potential hazard associated with the use of mains-powered
equipment connecting to this interface.
External equipment intended for connection to signal input, signal output or

other connectors, shall comply with the relevant IEC or international
standards (e.g. IEC 60950, CISPR 22 & CISPR 24 for IT equipment, and
the IEC 60601 series for medical electrical equipment).
Equipment not complying with IEC 60601 shall be kept outside the patient
environment, as defined in IEC 60601-1:2005 (at least 1.5m from the
patient).
The operator must not touch the connected equipment and the patient at
the same time as this would result in an unacceptable hazard.
Refer to Diagrams 1 & 2 below for typical configurations of connected

peripheral equipment.
Refer to Amplivox Limited at the address given on the front of this user
manual if advice is required regarding the use of peripheral equipment.

Diagram 1: Otowave 102 used with the supplied printer
Mains Outlet
Printer via IrDA Link
Printer Power
Supply
Otowave 102
Tympanometer

Diagram 2: Otowave 102 used with a computer & IrDA Link
Mains Outlet
Computer via IrDA Link
Computer Power
Supply
Otowave 102
Tympanometer

OM001 15 Otowave 102 Operating Manual

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OM001 15 Otowave 102 Operating Manual

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Amplivox Ltd

Otowave 102 Hand Held Tympanometer

Tel: +44 (0)1865 880846

Caution: Federal Law restricts this device to sale by or on the order of a

2. Important Safety Instructions......................................................... 5

3. Principles of Operation ................................................................... 6

4. Using the Otowave .......................................................................... 7

6. Saving Results in the Internal Database ..................................... 19

7. IrDA Communications ................................................................... 20

OM001-15 Otowave 102 Operating Manual Page 1

9. Data Management .......................................................................... 23

10. Performing Daily Checks .............................................................. 25

11. Routine Maintenance .................................................................... 26

12. Menu Summary .............................................................................. 27

13. Error Messages & Fault Conditions............................................. 30

14. Technical Specification................................................................. 32

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

Page 2 OM001-15 Otowave 102 Operating Manual

Thank you for purchasing an Amplivox Otowave 102, a hand-held, portable

1.1. Intended applications

The Otowave 102 is designed for use by audiologists, general practitioners,

OM001-15 Otowave 102 Operating Manual Page 3

1.5. Optional accessories

1.6. Warranty card (UK Customers only)

Please complete the enclosed warranty registration card and return it to

All Amplivox instruments are guaranteed against faulty materials and

 The pressure pump and transducers may go out of

 The lifetime of probe, probe seals and ear tips is

Page 4 OM001-15 Otowave 102 Operating Manual

READ THIS OPERATING MANUAL BEFORE ATTEMPTING TO USE

OM001-15 Otowave 102 Operating Manual Page 5

2.2. Electromagnetic compatibility (EMC) considerations

Medical electrical equipment needs special precautions regarding EMC and

3.1. Compliance measurement

The Otowave 102 measures the compliance of the tympanic membrane

To record the tympanogram the compliance is measured while the air

Page 6 OM001-15 Otowave 102 Operating Manual

3.3. Stapedial reflex measurement

Using the same principle it is also possible to establish whether a stapedial

4. Using the Otowave

4.1. Installing & replacing batteries

The Otowave 102 may be powered from Alkaline ‘AA’ batteries or

OM001-15 Otowave 102 Operating Manual Page 7

Batteries should only be changed outside the patient

4.2. Operating language

4.3. Controls and indicators

Page 8 OM001-15 Otowave 102 Operating Manual

Green Yellow Status

For a full description of indicators used, messages displayed and possible

OM001-15 Otowave 102 Operating Manual Page 9

Seal Nose Cone

4.5. Start-up and menu displays

Page 10 OM001-15 Otowave 102 Operating Manual

VIEW THE LAST TEST

4.6. Initial settings