GEOAXON KUDUWAVE 5000 User manual
GeoAxon KUDUwave User Manual Version 7.7 2
T
TABLE
ABLE
OF
OF C
CONTENTS
ONTENTS
I Warnings and afety Notices......................................................7
II End User License Agreement (EULA).........................................10
III Warranty and Disclaimer........................................................11
1. Limited Warranty................................................................11
2. Disclaimer..........................................................................11
IV Introduction..........................................................................12
1. Purpose of this manual........................................................12
2. Description of Markings and Labels.......................................13
3. Intended Use of the KUDUwave 5000....................................14
IV.3.1. Application pecification............................................14
IV.3.1.a. Medical Purpose.................................................14
IV.3.1.b. Patient Populations............................................14
IV.3.1.c. Device Placement...............................................14
IV.3.1.d. Operator Profile.................................................14
IV.3.1.e. Application........................................................15
IV.3.2. Frequently Used Functions.........................................15
IV.3.3. Details of Applied Parts.............................................15
4. Operator Training Requirements............................................16
IV.4.1. Basic Requirements..................................................16
IV.4.2. Training and Certification Requirements.......................16
5. Expected ervice Life..........................................................16
6. Disposal and Recycling........................................................16
V Technical pecification.............................................................17
1. ystem description & related models.....................................17
2. Conformity with tandards...................................................17
3. KUDUwave 5000.................................................................18
V.3.1. General pecifications................................................18
V.3.2. Audiometry pecifications...........................................19
V.3.3. Frequency pecifications............................................20
V.3.3.a. Air Conduction....................................................20
V.3.3.b. Bone Conduction.................................................20
V.3.3.c. Narrow Band Masking..........................................21
VI Getting tarted.....................................................................22
1. Introduction.......................................................................22
2. KUDUwave 5000 Description................................................22
3. PC Requirements................................................................24
VI.3.1. Minimum PC specifications........................................24
VI.3.2. How do I confirm my PC specifications?......................24
VI.3.3. In Need of Assistance?..............................................25
GeoAxon KUDUwave User Manual Version 7.7 3
4. KUDUwave oftware Pre-installation check list for PC..............25
5. Installation of the KUDUwave 5000.......................................26
VI.5.1. Unpacking the KUDUwave hardware...........................26
VI.5.2. Packaging Checklist..................................................26
VI.5.3. Model & erial number.............................................27
VI.5.3.a. erial number [ N]............................................27
VI.5.3.b. Model number...................................................27
VI.5.4. oftware installation.................................................28
VI.5.4.a. Installation from U B tick.................................28
VI.5.5. oftware Removal....................................................28
VI.5.6. Device Drivers.........................................................29
VI.5.7. oftware Launch......................................................29
VI.5.8. oftware Language..................................................30
VI.5.9. Registration.............................................................30
VI.5.10. Checking Device Connectivity..................................32
6. Post-installation check list....................................................33
VII Using and maintaining the KUDUwave 5000.............................34
1. Introduction.......................................................................34
2. Preparing the Test Environment............................................34
3. Preparing and Positioning the Patient....................................34
4. Preparing the KUDUwave 5000 equipment.............................35
VII.4.1. U B Cables............................................................35
VII.4.2. KUDUwave 5000 headset.........................................35
VII.4.3. Ear inserts.............................................................35
VII.4.4. Patient Response Button..........................................35
5. Positioning the KUDUwave 5000 headset...............................36
VII.5.1. tep 1: KUDUwave 5000 – Initial Position..................36
VII.5.2. tep 2: Ear Inserts.................................................36
VII.5.3. tep 3: KUDUwave 5000 – Final Position...................37
VII.5.4. tep 4: Patient Response Button...............................39
VII.5.5. (Optional) tep 5: Bone Vibrator Positioning..............40
6. Performing a Test................................................................40
VII.6.1. Remote testing.......................................................41
7. Cleaning and Maintenance...................................................41
VII.7.1. General Care..........................................................41
VII.7.2. Cleaning Procedure.................................................41
8. Calibration.........................................................................42
VII.8.1. Daily.....................................................................43
VII.8.2. Annual...................................................................43
9. torage and hipping..........................................................43
10. Traveling with your KUDUwave...........................................44
GeoAxon KUDUwave User Manual Version 7.7 4
VIII Upgrades, Maintenance and upport......................................45
1. Upgrades and New Features.................................................45
2. Frequently Asked Questions (FAQ)........................................45
3. upport ervice..................................................................48
VIII.3.1. Overview..............................................................48
VIII.3.2. Loan Devices.........................................................48
VIII.3.3. PC Problems..........................................................48
VIII.3.4. Online Virtual upport............................................49
VIII.3.5. ervice, upport and Maintenance Contract..............49
4. Troubleshooting..................................................................49
VIII.4.1. Troubleshooting Checklist.......................................50
VIII.4.2. Troubleshooting Form.............................................51
IX Notes...................................................................................53
GeoAxon KUDUwave User Manual Version 7.7 5
GeoAxon KUDUwave User Manual Version 7.7 6
I
I W
WARNINGS
ARNINGS
AND
AND S
SAFETY
AFETY N
NOTICES
OTICES
1) GENERAL WARNINGS AND NOTICES
The KUDUwave 5000 is highly sensitive and technically complex and
should be treated with care.
The KUDUwave is NOT suitable for use in the presence of flammable
anesthetic.
No modification of this equipment is allowed. Only use the components
supplied with the KUDUwave 5000.
2) POWER SUPPLY SAFETY
The KUDUwave 5000 is powered from two standard U B ports on a PC.
These are specified as being part of the KUDUwave 5000 medical
equipment system.
The KUDUwave 5000 must not be operated via a U B hub.
The Personal Computer used with the KUDUwave must be suitably
approved and setup as per its instructions. Particular attention must be
paid to ensure that the PC and all peripherals connected to it are
properly earthed if required.
3) PRECAUTIONS AGAINST EMC INTERFERENCE
Radiated electromagnetic fields, particularly from high powered medical
devices, must be avoided as they may possibly cause the KUDUwave
5000 to become temporarily unresponsive. Likewise high powered
portable/mobile RF devices may possibly affect its performance. As
such, the KUDUwave 5000 should not be used adjacent to, or stacked
with, other electrical equipment, or if such placement is absolutely
necessary, the device must be observed to verify normal operation
before being used to test patients.
I Warnings and afety Notices
GeoAxon KUDUwave User Manual Version 7.7 7
The KUDUwave 5000 may emit low levels of radiation, as such care
must be taken not to use sensitive equipment in close proximity.
hould the KUDUwave 5000 or PC software become unresponsive this
is a typical indication that the unit is experiencing significant EMC
interference. Please ensure that the KUDUwave 5000 is used in an EMC
interference free environment.
) OPERATOR QUALIFICATIONS AND TRAINING
Audiometry must be performed by skilled, trained caregivers. and
GeoAxon is not liable for morbidity caused by any untrained operators.
Please see the Operator Training Manuals and the Operator Training
section in this User Manual for more details.
5) SAFE USE OF USB CABLES
Please wind the U B cable up in large loops to prevent unnecessary
damage to the U B cables. Always fold the cable double before winding
up the twisted dual cable in large loops.
6) SOFTWARE OPERATION
The KUDUwave system software, eMOYO, must be installed before the
KUDUwave headset is attached for the first time. This will ensure that
the PC settings do not interfere with the functionality of the KUDUwave.
The eMOYO application must be launched with Administrative rights in
order for it to function correctly.
7) ACCESSORIES AND DISPOSABLES
Use only the KUDUfoam ear tips supplied by GeoAxon. The KUDUwave
is calibrated specifically for use with KUDUfoam ear tips. Other insert
ear tips will cause incorrect test results.
I Warnings and afety Notices
GeoAxon KUDUwave User Manual Version 7.7 8
The KUDUfoam ear tips are disposable and for single use only to
prevent hazardous cross contamination. GeoAxon will not be liable for
any complications if you re-use the ear tips.
Use only accessories and disposables that are defined as part of the
KUDUwave 5000 system.
8) PATIENT POSITIONING
Please ensure the patient is at all times positioned at least 1.5 meters
from the PC in order to ensure that the Patient Zone is free from all
hazards and distractions.
In order to minimize any risk of sound interference, the “Patient Zone”
must be both quiet and free from all distractions that could potentially
influence and distract either the operator or the patient.
9) SHIPPING AND STORAGE
The original casing is the preferred method for use when shipping the
KUDUwave. IMPORTANT: Always seal the shipping case securely and
mark as FRAGILE.
I Warnings and afety Notices
GeoAxon KUDUwave User Manual Version 7.7 9
II
II E
END
ND U
USER
SER L
LICENSE
ICENSE A
AGREEMENT
GREEMENT
(EULA)
(EULA)
This GeoAxon End-User License Agreement (EULA) is a legal agreement
between you (either an individual or a single entity) and GeoAxon for
the KUDUwave device and software. oftware includes the PC software
and the KUDUwave device firmware.
oftware may be installed and used by any number of people (either an
individual or a single entity). The software may be installed on any
number of computers. The software can be operated over a network by
any number of people from any number of computers. Whenever it is
plugged in, the KUDUwave will check that the PC oftware is suitable to
control it. Additional software functionality purchased will be associated
with a single device and such software will only work for devices that
have the license to use the new software.
The hardware may be used by any number of people (either an
individual or a single entity). The hardware may be used on any
number of PCs. The hardware can be operated over a network by any
number of people from any number of PCs.
Even though GeoAxon took care to ensure a safe and compliant device,
there is always the slightest possibility for error. GeoAxon and its
employees and consultants do not take responsibly for any
complications that may be the result of errors in the device or
software.
Due to continued development and product enhancement,
specifications are subject to change without notice.
GeoAxon reserves all rights not expressly granted.
II End User License Agreement (EULA)
GeoAxon KUDUwave User Manual Version 7.7 10
III
III W
WARRANTY
ARRANTY
AND
AND D
DISCLAIMER
ISCLAIMER
1.
1. Limited Warranty
Limited Warranty
GeoAxon warrants that the KUDUwave, if properly used and installed
(as per GeoAxon’s instructions), will be free from defects in material
and workmanship and will substantially conform to GeoAxon’s high
quality specifications for the period of 3 years as also stipulated on the
Terms and Conditions of your purchase invoice.
This WARRANTY:
begins on the date of purchase. (For your convenience, please
keep the dated tax invoice as evidence of this date)
is extended through distributors
covers defects
does not cover tamper, drop, misuse or modifications
If the KUDUwave, which is the subject of this Limited Warranty, fails
during the warranty period for reasons covered by this Limited
Warranty, GeoAxon will have the option to repair or replace the
KUDUwave. All shipping costs to repair or replace the device remain
the responsibility of the purchaser.
2.
2. Disclaimer
Disclaimer
The Purchaser shall have no claim against GeoAxon whatsoever,
notwithstanding the termination or lapse of any contract. GeoAxon will
not be responsible for loss or damage of any nature whatsoever
whether direct or indirect, consequential or otherwise, sustained as a
result of any goods or equipment supplied or any advice given or any
installation effected or any maintenance undertaken by GeoAxon being
in any way defective or absent or not conforming to the description
thereof as a result of any other cause whatsoever. Under no
circumstances will GeoAxon be liable for damage arising from misuse
or abuse of the goods. The Customer does hereby indemnify and hold
GeoAxon harmless against any claim by any third person arising
directly or indirectly out of any defect/s in the goods or equipment
supplied and or advice given to the Customer.
III Warranty and Disclaimer
GeoAxon KUDUwave User Manual Version 7.7 11
IV
IV I
INTRODUCTION
NTRODUCTION
1.
1. Purpose of this manual
Purpose of this manual
The intention of this manual is to give the user a good understanding of
how to operate the KUDUwave 5000 and to understand how the
different technologies work. It contains not only the technical
specifications but also details all potential hazards, usage
methodologies and all other information related to the purchasing,
maintenance and safe usage of the device.
The intention of this manual is not to train operators to be
professionals or to act as professionals.
Note: In Tele-Audiology, a subsection of Tele-Medicine, a facilitator
that might not be trained to perform the professional tests and
interpret the results might fit the KUDUwave on the patient for an
operator. This facilitator can not act as an operator or a professional.
The role of the facilitator is to assist an operator or professional to
facilitate the process of remote Tele-Audiology tests.
IV Introduction
GeoAxon KUDUwave User Manual Version 7.7 12
2.
2. Description of Markings and Labels
Description of Markings and Labels
The following markings and labels are used on the KUDUwave 5000
and on its accessories:
Symbol Description and Notes
Name and Address of Manufacturer:
GeoAxon Holdings (Pty) Limited
953 Soekmekaar street,
Faerie Glen,
00 3,
Gauteng,
South Africa
ymbol designating Type B Applied Parts
afety sign advising operator that accompanying
documents must be consulted
ymbol for the European Union Representative
erial Number ymbol and Unique erial Number for
this device
ymbol for “ ingle Use Only” application (this symbol
appears only on the ear-inserts packaging)
ymbol for CE Mark
IV Introduction
GeoAxon KUDUwave User Manual Version 7.7 13
3.
3. Intended Use of the KUDUwave 5000
Intended Use of the KUDUwave 5000
IV.3.1.
IV.3.1. Application Specification
Application Specification
The following sections comprise the Application pecification providing
a broad overview of the KUDUwave from a user’s perspective.
IV.3.1.a.
IV.3.1.a. Medical Purpose
Medical Purpose
The KUDUwave 5000 is an innovative audiometer featuring
“Ambidome” which provides compliant testing using its built-in sound
proofing, while including the functions found in a typical audiometer. It
achieved this through a combination of sound damping and real time
monitoring of the ambient noise. Its medical purpose is to assist in
testing a patient’s auditory responses in order to determine his or her
hearing thresholds and hence assist in diagnosing any hearing
impediments.
IV.3.1.b.
IV.3.1.b. Patient Populations
Patient Populations
There are no restrictions on a patient’s gender, age, weight, general
health or race for using the KUDUwave 5000. However, the KUDUwave
5000 cannot be used to test either very young children, or people with
physical or mental disabilities that prevent them from clearly signaling
that they have heard a test audio tone presented to them using the
patient response button. The patient should be calm and comfortable
and should not be distracted during testing.
IV.3.1.c.
IV.3.1.c. Device Placement
Device Placement
When in use the KUDUwave 5000 headset will be placed on the
patient’s head in exactly the same manner as normal headphones
would. The KUDUfoam ear tips will be positioned in the outer ear. If it is
to be used, the optional Bone Vibrator can subsequently be attached
and positioned on the patient’s forehead. When not in use there are no
specific requirements, beyond those outlined in this document, for its
placement and storage.
IV.3.1.d.
IV.3.1.d. Operator Profile
Operator Profile
The operator must be a trained healthcare professional (typically an
audiologist, general practitioner or occupational therapist or a
practitioner who has been trained in audiometry. They must have
IV Introduction
GeoAxon KUDUwave User Manual Version 7.7 14
received Operator pecific Training in using the KUDUwave 5000 by
GeoAxon (Pty) Ltd within the last 5 years. The operator should be able
to communicate fluently in English, and if different, in the primary
language of the patient.
IV.3.1.e.
IV.3.1.e. Application
Application
The KUDUwave 5000 is intended to be highly portable and should be
operated and maintained by a trained operator. It may be used as often
as is necessary (potentially more than 100 times a day), typically
indoors in an area free from noise and distractions. The KUDUwave
5000 should not be used in an excessively wet, hot or dusty
environment.
IV.3.2.
IV.3.2. Frequently Used Functions
Frequently Used Functions
As the KUDUwave 5000 is designed for continuous, regular usage, an
analysis of all frequently used functions has been performed in order to
ensure that none constitute an unacceptable risk to either the operator
or patient. These functions are detailed in the relevant sections of this
User Manual along with guidance as to how to minimize any potential
risks.
IV.3.3.
IV.3.3. Details of Applied Parts
Details of Applied Parts
The following parts are defined as “applied parts” in accordance with
IEC60601-1:
•Ear Inserts: The Left and Right Ear Inserts will be positioned in
the outer ear by the operator. They do not carry any electrical,
chemical or mechanical energy and contain no metallic parts but
they do facilitate the delivery of sound energy to the patient’s
ears.
•Bone Vibrator: The Bone Vibrator is positioned
against the patient’s forehead by the operator
where it can be used to deliver sound energy to
the patient. The KUDUwave 5000 uses a certified
Bone Vibrator from Radioear, model number
“B71”.
IV Introduction
GeoAxon KUDUwave User Manual Version 7.7 15
.
. Operator Training Requirements
Operator Training Requirements
IV.4.1.
IV.4.1. Basic equirements
Basic equirements
The operator must be a trained healthcare professional (typically an
audiologist, general practitioner or occupational therapist) or a
practitioner who has been trained in audiometry.
The operator must be able to read and communicate fluently in English,
and if different, in the primary language of the patient. More details
can be found in the GeoAxon Operator Training Manual.
IV.4.2.
IV.4.2. Training and Certification equirements
Training and Certification equirements
GeoAxon provides structured training for both facilitators and operators
of the KUDUwave 5000.
The operator must have received this training in using the KUDUwave
5000 within the last 5 years. The operator will be awarded a certificate
on completion of this training.
5.
5. Expected Service Life
Expected Service Life
The KUDUwave 5000 has an expected service life of at least 5 years of
continuous use. Regular maintenance and general care will prolong the
service life considerably. The KUDUwave 5000 can be used any number
of times without restriction as long as it is both calibrated, and used
and cleaned in accordance with the instructions in this User Manual.
6.
6. Disposal and Recycling
Disposal and Recycling
There are no specific disposal requirements for the KUDUwave 5000.
However, it is advisable that the unit is returned to GeoAxon so that
they may dispose of, or recycle it, in the most suitable manner.
IV Introduction
GeoAxon KUDUwave User Manual Version 7.7 16
V
V T
TECHNICAL
ECHNICAL S
SPECIFICATION
PECIFICATION
1.
1. System description & related models
System description & related models
The GeoAxon KUDUwave 5000 can test both pure tone air and bone to
the amplitude threshold levels of that of a Type 2 Clinical Diagnostic
Audiometer as described in the European tandard EN60645-1
specification. It conforms to the Type B requirements as set out in the
European tandard EN60645-2 Additionally, the KUDUwave 5000
headset provides a virtual “booth” allowing for compliant testing
without a physical booth.
A “+” in the model name is indicative that that KUDUwave can also
perform High-Frequency audiometry testing up to a frequency of
16kHz.
The KUDUwave 5000 can be upgraded to include built-in tympanometry
. A “T” for “Tympanometer” at the end of the model number of the
KUDUwave 5000 indicates that this device has a built-in
Tympanometer.
A “D” at the end of the model number is indicative that the KUDUwave
5000 can also perform DPOAE (Distortion Product Otoacoustic
Emissions) testing.
An “I” at the end of the model number indicates that the KUDUwave
can perform in ear testing while fitting a hearing aid.
2.
2. Conformity with Standards
Conformity with Standards
The KUDUwave 5000 has been independently examined, tested and
certified by a registered Notified Body in order to ensure it conforms in
full with each of with the Audiometry, afety and Design tandards
detailed in the General and Audiometry pecifications.
V Technical pecification
GeoAxon KUDUwave User Manual Version 7.7 17
3.
3. KUDUwave 5000
KUDUwave 5000
V.3.1.
V.3.1. General Specifications
General Specifications
Dimensions 210mm X 260mm X 110mm
Net Weight 250g
Shipping Weight 1,800g
Shipping Dimensions 410mm X 320mm X 190mm
Power supply 2 standard PC / Laptop U B ports (5V,
500mA max per port)
Safety and Design Standards IEC60601-1 2nd edition, IEC60601-1-
1; IEC6060-1-2, IEC60601-1-6,
I O14971
Medical Device Class Class IIa
Measurement & Labeling Standards I O1000/80/181/EEC, I O1041,
EN980
Type of protection (electric shock) Class II
Degree of protection (electric shock) Type B
Warm up time 10-20 seconds
Protection against ingress (IP) No specific protection
Operational Temperature 0°C to +40°C
Usage environment Indoor use only
Protection against pollution Pollution degree 2
Operational Humidity 5% to 90% non-condensing
Operational ambient pressure 500 hPa to 1 200 hPa
Operational background sound levels < 70 dB LP (100 Hz – 8 kHz)
Shipping & Storage Temperature -5°C to +55°C
Shipping & Storage Humidity 5% to 90% non-condensing
Supplied Equipment and Accessories
that make up the ME System
KUDUwave 5000 headset
KUDUfoam ear tips
2 x 3 meter U B cables
Logitech Precision Gamepad
B71 bone vibrator & headband
User Manual
Quick tart Cards
V Technical pecification
GeoAxon KUDUwave User Manual Version 7.7 18
V.3.2.
V.3.2. Audiometry Specifications
Audiometry Specifications
AudiometryStandards IEC60645-1, IEC60645-2; AN I 3.6
Pure Tone Audiometer Type Type 2, Basic Diagnostic in accordance
with IEC60645-1
Monosyllabic Speech Audiometer Type Type B, in acc. with IEC60645-2 (1993)
Maximum patient response time 1.5 seconds
Bone Conduction Frequency Range 250Hz to 8000Hz
Air Conduction Frequency Range 125Hz to 8000Hz
Frequency Accuracy <0.05%
Air Conduction Total Harmonic istortion <2.5%
Bone Conduction Total Harmonic
istortion
<5.5%
Air conduction transducers “Eartone 3A” transducer copies
Air conduction system ound is conducted through Ear Inserts.
The combined ear-cup and ear-insert
attenuation is always greater than 33dB
(typically between 50dB and 60dB).
Air conduction calibration Transducers calibrated using G.R.A.
IEC711. RET PL as per I O389.
Pure Tone presentation Pure Tone or Warble Tone
Warble Tone Waveform ine wave
Warble Tone Repetition Rate 4Hz to 20Hz (Default is 5Hz)
Warble Tone Frequency eviation 5% to 25% (Default is 10%)
Bone conduction transducer Radioear B71 (50Ω) Headband provides
5N static force.
Bone conduction system The Bone Vibrator is positioned on the
patient forehead. Airborne sound
vibration has no effect on testing due to
sound insulation and masking.
Masking Manual or automatic narrow band
masking. Levels equivalent to Pure Tones
Modes of operation Manual or Automatic (Hughson &
Westlake method - I O 8253-1)
Speech signal calibration All words in word lists calibrated against
a 1kHz calibration signal
Talk forward Adjustable 50dB PL to 110dB PL
V Technical pecification
GeoAxon KUDUwave User Manual Version 7.7 19
V.3.3.
V.3.3. Frequency Specifications
Frequency Specifications
V.3.3.a.
V.3.3.a. Air Conduction
Air Conduction
Maximum Air Hearing Levels
without harmonic distortion dB-SPL
125Hz 85
250Hz 95
500Hz 100
1000Hz 110
1500Hz 110
2000Hz 110
3000Hz 105
000Hz 100
6000Hz 95
8000Hz 90
V.3.3.b.
V.3.3.b. Bone Conduction
Bone Conduction
Maximum Bone Hearing Levels
without harmonic distortion dB-SPL
125Hz N/A
250Hz 35
500Hz 50
1000Hz 65
1500Hz 70
2000Hz 65
3000Hz 65
000Hz 65
6000Hz N/A
8000Hz N/A
V Technical pecification
GeoAxon KUDUwave User Manual Version 7.7 20
Table of contents
