KUDUwave 5000 User manual

eMoyo
thinking out the booth
User Manual

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Doc Number: EM-KW-IFU | Revision 07
Tel: [phone] | Fax: [phone] | Email: [e-mail]
Address: 179 Beyers Naude Drive, Northcli, Johannesburg, 2195, South Africa
eMoyoDotNet (Pty) Ltd | Reg No: 2005/032169/07 | www.emoyo.net

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Contents
1. Introducon
Purpose of this Manual
Medical Purpose
Paent Populaons
Device Descripon
Device Placement
Applicaon
Frequently Used Funcons
Details of Applied Parts
Descripon of Symbols and Markings
2. Operator Training Requirements
Basic Requirements
Training and Cercaon Requirements
3. Geng Started
Unpacking the KUDUwave™ Hardware
KUDUwave™ Conguraons
Packaging Checklist
Serial Number
Soware Installaon
Device Drivers
Soware Launch
Soware Language
Preparing the Test Environment
Preparing and Posioning the Paent
Checking Device Connecvity
4. Preparing the KUDUwave™ Equipment
Twisted KUDUwave™ Dual USB Cable
KUDUwave™ Headset
Ear Inserts
USB Paent Response Buon
5. Posioning the KUDUwave™ Headset
Step 1: KUDUwave™ – Inial Posion
Step 2: Insert Earps
Step 3: KUDUwave™ – Final Posion
Step 4: Paent Response Buon
Step 5: Bone Vibrator Posioning (Oponal)
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6. Performing a Test
Remote Tesng
7. Cleaning and Maintenance
General Care
Cleaning Procedure
When Cleaning the KUDUwave™
Calibraon
Daily Calibraon
Annual Calibraon
Ad Hoc Calibraons
Calibraons by Other Organisaons
8. Storage and Shipping
9. Expected Service Life
10. Disposal and Recycling
11. Traveling with Your KUDUwave™
12. Upgrades, Maintenance and Support
Upgrades and New Features
Frequently Asked Quesons (FAQs)
13. Support Service
Loan Devices
Personal Computer Problems
Online Virtual Support
Service, Support and Maintenance Contract
14. Troubleshoong
Troubleshoong Checklist
In Need of Assistance
15. Technical Specicaons
Standards
Instrument Specicaons
Audiometry Specicaons
Air Conducon Frequency Specicaons
Bone Conducon Frequency Specicaons
Narrowband Masking
Replacement Item Specicaon
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16. Electromagnec Compability (EMC)
17. End User License Agreement (EULA)
18. Warranty and Disclaimer
Limited Warranty
Disclaimer
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1. Introducon
Purpose of this Manual
The intention of this manual is to provide you with a good understanding of
the KUDUwave 5000 (from hereon referred to as KUDUwave™) operaons, and to
understand how its dierent technologies work together.
The manual contains technical specicaons and also details potenal hazards,
usage methodologies and other informaon related to the purchasing, maintenance
and safe usage of the device.
Please note that this manual’s purpose is not to train KUDUwave™ operators to be
healthcare professionals or to act as such.
If you would like to aain a hard copy of this manual, please contact eMoyo and
one will be delivered to you free of charge.
Note: In tele-audiology, a subsecon of telemedicine, a facilitator that might not be
trained to perform the professional tests and interpret the results may t the
KUDUwave™ on the paent for an operator. This facilitator cannot act as an
operator or a professional. The role of the facilitator is to assist an operator or
professional to complete the process of remote tele-audiology tests.
The following secons providing a broad overview of the KUDUwave™ from a
user’s perspecve.
Medical Purpose
The KUDUwave™ is a mobile audiometer featuring Ambi-Dome™ technology, which
provides compliant tesng outside a cered sound room using its built-in sound
proong, while including the funcons found in a typical audiometer. This is achieved
through a combinaon of sound damping and real me monitoring of ambient noise. The
KUDUwave™’s medical purpose is to assist in tesng a paent’s behavioural auditory
responses in order to determine their hearing thresholds, and as such assist in diagnosing
any hearing impediments.

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Paent Populaons
There are no restricons on a paent’s gender, age, weight, general health or race
for using the KUDUwave™. However, the KUDUwave™ cannot be used to test
very young children, or people with physical or mental disabilies that prevent
them from clearly signaling that they have heard a test audio tone presented to
them. During tesng the paent should be calm and comfortable and should not be
distracted.
Device Descripon
The KUDUwave™ looks like a normal circumaural earphone headset typically
used to listen to music. However, the KUDUwave™’s circumaural cups also help
to aenuate environmental ambient noise. The KUDUwave™ electronics are
all built into the headset, meaning the headset and the control are combined
into a single, compact device and not separate physical modules (i.e. there is no
separate box to drive the audiometer).
Device Placement
Place the KUDUwave™ headset on the paent’s head, above the ears and carefully
insert the foam earps into the each of the paent’s ears. Carefully place each Ambi-
Dome™ over one ear at a me, and once placement is secure, ensure that the sound
tubes are sll connected before starng with a test. If needed, the KUDUwave™’s
bone vibrator can be aached and posioned on the paent’s forehead. When not in
use there are no specic requirements, beyond those outlined in this document, for its
placement and storage.
Applicaon
The KUDUwave™ is designed to be completely portable and should be operated
and maintained by a trained operator. It may be used for tesng as oen as required
(potenally more than 100 mes a day), typically indoors in an area free from noise
and distracons. The KUDUwave™ should not be used in an excessively wet, hot
or dusty environment. The KUDUwave™ can be used in an open air tesng that
adheres to the above requirements.

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Frequently Used Funcons
As the KUDUwave™ is designed for connuous, regular usage. An analysis of all
its frequently used funcons has been performed in order to ensure that none
constute as an unacceptable risk to either the operator or paent. These funcons
are detailed in the relevant secons of this User Manual, with guidance describing
how to minimise any potenal risks.
Details of Applied Parts
The following parts are dened as “applied parts” in accordance with
BS EN 60601-1:
Ear Inserts: The Le and Right Ear Inserts will
be posioned in the outer ear by the operator.
They do not carry any electrical, chemical or
mechanical energy and contain no metallic parts,
and facilitate the delivery of sound energy to the
paent’s ears.
Bone Vibrator: The bone vibrator is posioned
against the paent’s forehead by the operator.
From this posion it can be used to deliver
sound energy to the paent’s cochlea. The
KUDUwave™ uses a cered bone vibrator
from Radioear.

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Descripon of Symbols
The following important symbols are used on the KUDUwave™ and its accessories:
Symbol Descripon
Manufacturer, eMoyoDotNet (Pty) Ltd, 179 Beyers Naude Drive,
Johannesburg, South Africa
EC Authorised Representave, PSF Medical BV, Marten Messweg 8, 3068AV
Roerdam, The Netherlands
Symbol for CE Mark with Noed Body Number.
Conforms to Medical Device Direcve 93/42/EEC.
Symbol designang Type B Applied Parts according BS EN 60601-1.
or
Cauon. Indicates the need for the user to consult the instrucons for use
for important cauonary informaon such as warnings and precauons that
cannot, for a variety of reasons, be presented on the medical device itself.
or
Consult instrucons for use. Indicates the need for the user to consult the
instrucons for use.
Single use only.
Serial number.
Batch code. Indicates the manufacturer's batch code so that the batch or lot
can be idened.
Ingress protecon.
Keep Dry. Indicates that the medical device needs to be protected from
moisture
Temperature limit. Indicates the temperature limits to which the medical
device can be exposed safely.
Humidity limit. Indicates the range of humidity to which the medical device
can be safely exposed.
Fragile, handle with care. Indicates a medical device that can be broken or
damaged if not handled carefully.

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2. Operator Training Requirements
Basic Requirements
The operator must be a trained healthcare professional (typically an audiologist,
hearing aid acouscian, general praconer, ENT, nurse or audiometrist) or a
praconer who has been trained in audiometry. The operator must be able to read
and communicate uently in English, and as needed, in the primary language of the
paent.
Training and Cercaon Requirements
eMoyo provides structured training for both facilitators and operators of
the KUDUwave™. The operator will receive a cercate of compleon aer
successfully compleng his/her training.
3. Geng Started
This secon outlines the installaon and setup procedures of the KUDUwave™.
Warning: The KUDUwave™ is highly sensive and technically complex and
should be treated with care.
The ear cups of the KUDUwave™ block out the ambient noise as a rst
aenuaon barrier. Tubes which t earps can be found at the boom of each
ear cup. Earps are inserted into the paent’s ear, and act as a second sound
aenuaon barrier. The ear cups are ed over the insert earps.
The KUDUwave™ is controlled via standard USB cables that connect each earcup
of the The KUDUwave™ to a personal computer. The USB cables also provide the
requisite power to the KUDUwave™.

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The bone vibrator is mounted on an independent headband and is connected
directly to the KUDUwave™ headset. The bone vibrator can be kept in posion on
the KUDUwave™ using the headband screw.
Unpacking the KUDUwave™ Hardware
The KUDUwave™ is packaged in a robust shock absorbing case designed to protect
it during transportaon. Inspect the case for signs of any damage and nofy your
supplier immediately if any signs of mechanical or physical damage are found.
Warning: eMoyo recommends that you use the robust shock absorbing carry
case to ship your KUDUwave™. Please mark the package as FRAGILE.
Circumaural Ear Seal
(ear comfort cushion)
Circumaural ear cushion for secure and comfortable
t and the second noise blocking stage
Bone Vibrator
For diagnosc
pure tone bone
conducon tesng
Bone Vibrator Spring & Swivel
Adjustable Headband
& Swivel link
Allows for secure and
adjusts to t all head sizes
KUDUwave
TM Memory Foam Earp
The third stage of noise blocking with a noise
reducon rang (NRR) of 34 dB (disposable)
Sound Reecve Ear Cup
Each cup houses an individual
audiometer as well as
funconing as the rst stage of
noise blocking

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KUDUwave™ Conguraons
KUDUwave™ Prime KUDUwave™ Plus KUDUwave™ Pro
Screening Screening Screening
-Diagnosc Diagnosc
--Monitoring of Ototoxicity
Pure Tone Air Conducon Pure Tone Air
and Bone Conducon
Pure Tone Air and Bone
Conducon
Acve Noise Monitoring Acve Noise Monitoring Acve Noise Monitoring
Automated and Manual
Tesng Protocols
Automated and Manual
Tesng Protocols
Automated and Manual
Tesng Protocols
Paent Management and
Medical Record Suite
Paent Management and
Medical Record Suite
Paent Management and
Medical Record Suite
Telemedicine Enabled Telemedicine Enabled Telemedicine Enabled
- - Extended High
Frequency (up to 16kHz)
PC Based Soware PC Based Soware PC Based Soware
Packaging Checklist
Please check that all items listed below are received in good condion. If any items
are missing or damaged, immediately nofy your KUDUwave™ distributor.
• The KUDUwave™ headset
• Three meter long twisted KUDUwave™ dual USB cable
•
USB paent response buon
•
Radio Ear Bone vibrator with headband aached to the KUDUwave™
headband with a headband screw (Plus and Pro conguraons only)
•
Calibraon cercate
•
Two sound tubes with earp couplers aached to the KUDUwave™
•
Spares (6 sound tubes and 1 brass connector)
• Starter pack of earps

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Serial Number
The unique serial number is clearly marked on the boom of the KUDUwave™
headset. Serial number informaon is required when contacng customer support.
Soware Installaon
If your KUDUwave™ contoller PC was professionally congured by eMoyo, all
the necessary soware will already be installed, opmised and inialised. Should
this not be the case, or should you wish to install the soware on more than one
computer, please contact eMoyo and on of our friendly technicians will be assigned
to assist you.
Device Drivers
Drivers will automacally begin installing as the KUDUwave™’s USB cables have
been plugged into a personal computer. The KUDUwave™ is a plug and play device
and all drivers will be installed automacally.
If the device is plugged into a new USB port on the same computer for the rst
me, then some drivers will be installed again. Please wait unl Windows noes
you that the drivers have been installed successfully.
Warning: If you launch the KUDUwave™ soware before the drivers were
installed, the KUDUwave™ soware will prompt you that it could
not nd the device, even though the device is plugged in.
This can happen if you launch the KUDUwave™ soware shortly
aer plugging the KUDUwave™ into the USB ports for the rst me.

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Soware Launch
You should nd the emoyo4.0 shortcut on your PCs desktop. Alternavely you can
nd emoyo4.0 under programs in your start menu. Launch the soware by clicking
the emoyo4.0 icon.
Warning: The emoyo4.0 soware must be launched with Administrator
rights in Windows 7, 8 and 10 in order to ensure that it funcons
correctly. To do this right click on the emoyo4.0 icon and select “Run
as administrator”.
Soware Language
The soware is currently only available in English.
Preparing the Test Environment
It is essenal that the test environment is as quiet as possible in order to ensure test
compliance and that the paent is not disturbed.
The KUDUwave™ monitors the ambient noise in real me and will indicate if
ambient noise is suciently loud to disrupt the test.
The test environment should be free from any distracons that may disturb either

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the operator or the paent as these may result in incorrect test results.
Preparing and Posioning the Paent
The paent should be seated in the test environment at least 1.5 meters from
the test computer. It is important that the paent cannot see the screen of the
test computer. Care should be taken to ensure the paent is as comfortable as is
possible to minimise distracons.
Should the paent be unable to sit, care must be taken to ensure they are
posioned in as comfortable and relaxed a posion as is possible. Paents who are
notably anxious should be reassured and made as comfortable as possible.
Checking Device Connecvity
Make sure the KUDUwave™ is plugged into the personal computer before you
select any of the KUDUwave™ tests in the eMoyo soware.
If the KUDUwave™ is plugged into the personal computer both the Red and Blue
LED will light up and you will be able to press the “Next >>” buon to connue
performing the test. If the device is not plugged in it will not be possible to proceed.
4. Preparing the KUDUwave™ Equipment
Twisted KUDUwave™ Dual USB Cable
Plug the larger USB plugs of the twisted KUDUwave™ USB cable into the
USB ports of the test personal computer. Plug the smaller plugs of the twisted
KUDUwave™ USB cable directly into the boom of the KUDUwave™ headset. The
KUDUwave™ will indicate the right side with a red light, and will indicate the le
side with a blue light when powered.
Ensure that both USB cables are securely connected from the le and right
KUDUwave™ ear cups to two USB ports on the test personal computer.
The USB cables must not be tangled or le in a posion where they may cause
someone to trip over or become entangled in them.

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Warning: Please wind the USB cable up in large loops to prevent
unnecessary damage before storing it away in the KUDUwave™
case.
KUDUwave™ Headset
The headset must be placed on a stable surface. It must be cleaned and disinfected
aer each use with a cleaning wipe in compliance with EN1276 that are intended
for use on plasc items.
Ear Inserts
A new set of foam earps must be rmly aached to the plasc tubes. Used earps
must be disposed of as medical waste aer tesng.
Warning: The foam earps are disposable and for single use only to prevent
hazardous cross contaminaon. eMoyo will not be held liable for any
complicaons if earps are reused.
USB Paent Response Buon
The USB cable from the Paent Response
Buon must be rmly aached to the
USB connector on the le ear-cup of the
KUDUwave™. Aaching it to the right ear-cup

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is not recommended. Alternavely it may also be aached directly to the personal
computer.
5. Posioning the KUDUwave™ Headset
Although there are a number of ways to posion the KUDUwave™ correctly on the
paent’s head, the following technique is recommended:
Step 1: KUDUwave™ – Inial Posion
The KUDUwave™ headset should rst be gently placed on the paent’s head,
resng just above their ears. Care must be taken to ensure that the headset is the
correct way around (i.e. the le ear cup must be on the paent’s le hand side and
vice versa).
Step 2: Insert Earps
Insert the foam earp onto the tubing, and make sure that the earp is inserted
up to the end of the brass ridge. Squeeze the foam p between thumb and index
nger. Pull the ear by the pinna (up and back in adults and down in children) and
insert the squeezed foam p into the canal. Make sure the p is inserted deep
enough into the ear canal. The earp must be held in the ear canal unl the foam
has expanded suciently so that it is securely in place. If the earp is t loosely in
the ear canal then a larger size foam earp should be used. Sound leakage around a
loosely ed earp will result in tesng inaccuracy.

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Warning: Improper inseron of earps may aect test results.
Step 3: KUDUwave™ – Final Posion
The headset can now be lied up to, and simultaneously placed over, the paent’s
ears. Ensure the ear cups are supported by the headband and do not hang on the
ears. Care must be taken not to dislodge the ear inserts from the paent’s ear
canal.
It is important to li the le and right ear cups slightly in turn to visually conrm the
ear inserts are sll correctly posioned. Make sure that the tubing is not tangled
under the cups. The tubing should loop out under the cups towards the front of the
ear to avoid tangling and or bending.
Step 4: Paent Response Buon
The Paent Response Buon must be placed in the paent’s hands. Ensure that
the cable does not become tangled or damaged. The paent must keep his nger
on the buon and be ready to press it when a sound is played. The paent must be
told to press the buon as quickly as possible and then let go of the buon.

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Step 5: Bone Vibrator Posioning (Oponal)
If the bone vibrator is to be used, the metal headband must be adjusted and placed
over the paent’s head in such a way as to ensure that it is posioned carefully in
line with the middle paron between eyebrows/middle of the eyes of the paent’s
forehead.
Warning: Bone vibrators are calibrated to a specic KUDUwave™. They are
not interchangeable between KUDUwaves™. Swapping of bone
vibrators between devices may result in inaccurate tesng. If
you are unsure about which bone vibrator should be used with
your KUDUwave™ please check its calibraon cercate or
alternavely contact eMoyo support.
6. Performing a Test
Please see the emoyo4.0 User Manual for full details on how to perform KUDUwave™
tone threshold test (manual or automac), bisyllabic speech test (speech recepon
threshold) and monosyllabic speech test (speech discriminaon), using the
KUDUwave™.
For a quick reference, please see the emoyo4.0 Quick Start Guide included with your
device or use the help included in the eMoyo soware package (this can be accessed
by pressing the “?” buon in the eMoyo applicaon whilst performing a KUDUwave™
test.

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Remote Tesng
The KUDUwave™ can easily and safely be used for remote tesng over local and
internet connecons.
To test remotely
1. The trained operator starts the eMoyo soware applicaon on his or her
local personal computer.
2. A connecon is made to a KUDUwave™ headset connected to a remote
personal computer.
3. The remote personal computer is specied using its unique IP address.
4. A trained facilitator can then t the KUDUwave™ headset on the paent.
The operator can proceed with the test.
Both the operator and facilitator need to complete the required eMoyo
KUDUwave™ training.
7. Cleaning and Maintenance
General Care
The KUDUwave™ is a highly sensive, state of the art device that must be treated
with care. It must be cleaned and disinfected regularly and care should be taken not
to damage any of the sensive microphones or speakers when cleaning or handling
the device.
Cleaning Procedure
The KUDUwave™ must be thoroughly cleaned and disinfected aer each and
every use (i.e. before each new paent is tested) with a cleaning and disinfecon
wipes complying with EN1276 that are intended for use on plasc items.