Maico MedRx Otowave 102 User manual

853497_OM001-14 Otowave 102 Operating Manual Page 1
MedRx Otowave 102
Hand Held Portable Tympanometer
Operating Manual
(Applies from serial number 37400 onwards)

Page 2 853497_OM001-14 Otowave 102 Operating Manual
CONTENTS
1. Introduction......................................................................................4
1.1. Intended applications.........................................................................4
1.2. Features ............................................................................................4
1.3. Unpacking..........................................................................................4
1.4. Standard contents .............................................................................5
1.5. Optional accessories.........................................................................5
1.6. Warranty card....................................................................................5
1.7. Guarantee..........................................................................................5
2. Important Safety Instructions......................................................... 6
2.1. Precautions........................................................................................6
2.2. Electromagnetic compatibility (EMC) considerations ........................7
3. Principles of Operation...................................................................7
3.1. Compliance measurement.................................................................7
3.2. Tympanogram ...................................................................................8
3.3. Stapedial reflex measurement...........................................................8
4. Using the Otowave..........................................................................8
4.1. Installing & replacing batteries ..........................................................9
4.2. Operating language...........................................................................9
4.3. Controls and indicators......................................................................9
4.4. The probe........................................................................................11
4.5. Start-up and menu displays.............................................................11
5. Taking measurements...................................................................12
5.1. Prior to testing and Ambient conditions...........................................12
5.2. Ear tip..............................................................................................12
5.3. Performing a test.............................................................................13
5.4. Ear seal check.................................................................................17
5.5. Reflex options..................................................................................18
5.6. Error messages...............................................................................19
6. Saving Results in the Database...................................................19
7. IrDA Communications...................................................................21
8. Transferring the Results...............................................................22
8.1. Sending the results to a printer........................................................22
8.2. Sending the results to a computer...................................................22

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9. Data Management..........................................................................24
9.1.List records......................................................................................25
9.2. Print records....................................................................................25
9.3. Send records to a computer............................................................25
9.4. Delete records.................................................................................26
10. Performing Daily Checks..............................................................26
11. Routine Maintenance ....................................................................27
11.1. Cleaning the Otowave.....................................................................27
11.2. Eartip and Probe..............................................................................27
11.3. Calibration and Repair of the Instrument.........................................27
12. Menu Summary..............................................................................28
12.1. Main menu.......................................................................................28
12.2. Sub-Menu selections.......................................................................28
13. Error Messages & Fault Conditions.............................................31
14. Technical Specification.................................................................33
14.1. Performance....................................................................................33
14.2. Equipment classification..................................................................36
14.3. Symbols...........................................................................................36
15. Ordering Consumables and Accessories...................................37
16. EMC Guidance & Manufacturer’s Declaration ............................38
17. Use with Non-medical Electrical Equipment...............................44

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1. Introduction
Thank you for purchasing a MedRx 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 MedRx Otowave 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 of data via an infrared link to one of two thermal printers
that may be selected by the user
Transfer of data to a computer via an infrared IrDA link for storage
and display using the NOAH application
English, French or German operating language
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 tympanometer or
MedRx if you purchased direct.
Please retain the carton and packaging as the tympanometer will need
calibrating on an annual basis and should be returned to MedRx in its
original shipping carton.

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1.4. Standard contents
MedRx Otowave 102 Tympanometer
4 x 1.5V ‘AA’ Batteries (UK only)
4 in 1 test cavity assembly
Set of disposable ear-tips
Carrying case
Operating manual
Calibration certificate
Warranty card
1.5. Optional accessories
NOAH impedance module Portable thermal printer
Additional sets of ear tips Additional probe tip
Additional rolls of thermal printer paper Infra-red USB Adapter
Note: If the thermal printer has been purchased it should be charged for a
period of 8 hours before being used. Refer to the printer instructions for
further details.
1.6. Warranty card
Please complete the enclosed warranty registration card and return it to
MedRx. This will enable us to register your purchase, help with your
enquiries and provide technical support.
1.7. Guarantee
All MedRx instruments are guaranteed against faulty materials and
manufacture. The instrument will be repaired free of charge for a period of
one year from the date of dispatch if returned, carriage paid, to the MedRx
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 eartips is
dependent upon conditions of use. These parts are
only guaranteed against faulty materials or
manufacture.

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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.
Use the recommended batteries (see Section 4.1); do not mix battery types
or old and new batteries.
Remove batteries from the instrument if the instrument is not going to be
used for more than a month.
Always set the BATTERY TYPE in the CONFIGURATION MENU to show
which type of batteries are fitted. See Section 12.
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.

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Thermal paper printouts fade with exposure to light or heat. Photocopying
the patient record test results will ensure a more permanent record is kept.
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 16. 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 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

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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 sound pressure level (SPL) of this
stimulus is increased in steps until the stapedial muscles respond causing
the tympanic membrane to become stiffer, or a preset maximum SPL 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).
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.

853497_OM001-14 Otowave 102 Operating Manual Page 9
4.1. Installing & replacing batteries
The Otowave 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 we recommend alkaline cells are
fitted. NiMH batteries have a high self-discharge rate and are likely to need
recharging if left unused for several weeks.
To fit the cells remove the battery compartment cover on the base of the
Otowave. Fit the cells as indicated inside the battery compartment.
Batteries should only be changed outside the patient
environment. The operator should not touch the
battery connectors and the patient simultaneously.
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).
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 has !in front of it, or when advised to do so at switch-on.
Removing the batteries does not affect the configuration, the contents of
the database, the calibration settings or the results of the last test.
4.2. Operating language
To set the operating language (English, 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 (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

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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 will switch off automatically if no
key is pressed for 90 seconds. This time can be extended to 180 seconds
in the CONFIGURATION menu (see Section 12.2).
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 & ready to use
Off
Slow flash
Waiting for probe to be inserted
Slow flash
Off
Taking a measurement
On
Off
Pump error at switch-on.
Measurement error, see Section 13.
On
Flickering
Sending data to a computer
Display
Indicators
Navigation
Keys
On/Off key
Probe