otometrics MADSEN Alpha OAE User manual

MADSEN Alpha OAE Screener
User Manual
Doc no. 7-50-1370-US/01
Part no. 7-50-13700-US
0 4 5 9

Copyrightnotice
No part of this documentation or program may be reproduced, stored in a retrieval system, ortransmitted, in any form orby any
means, electronic,mechanical,photocopying, recording, or otherwise, without the prior written consent of GNOtometricsA/S.
Copyright© 2013, GNOtometricsA/S
Published in Denmark by GNOtometricsA/S, Denmark
All information, illustrations, and specifications in this manual are based on the latest productinformation available at the time of
publication. GNOtometricsA/S reserves the right to make changes atany time without notice.
Versionrelease date
2013-12-04
Technicalsupport
Please contact your supplier.
2 Otometrics - MADSEN Alpha OAE

Table of Contents
1 Introduction 7
1.1 Printing 7
1.2 Intended Use 7
1.3 About this manual 8
1.4 Typographical conventions 9
1.4.1 Navigating this manual 9
2 Unpacking and Installation 11
2.1 Unpacking 11
2.2 Views of Alpha OAE 11
2.2.1 Front and rear view 11
2.2.2 Top and bottom view 12
2.2.3 Display 12
2.2.4 Ear probe 12
2.3 Storage 13
2.4 Assembly 13
2.5 Powering 13
2.5.1 The battery 13
2.5.2 Inserting the battery in Alpha OAE 14
2.5.3 Batterystatus 14
2.5.4 Charging the battery with the external charger 15
3 Getting Started with Alpha OAE 17
3.1 Switch on Alpha OAE 17
3.1.1 Power-saving mode and automatic power-off 17
3.1.2 The Alpha OAE screens 17
3.1.3 The Home menu 18
4 Preparing for testing 21
4.1 Preparing Alpha OAE 21
4.2 Preparing the equipment 21
4.2.1 Preparing the probe for testing 21
4.2.2 Connecting the probe 21
4.3 Preparing the test environment 22
4.4 Preparing the patient 22
4.4.1 Fitting the eartip on the probe 23
4.4.2 Inserting the probe with eartip in the patient’s ear canal 23
5 Testing with Alpha OAE 25
5.1 Selecting child mode 25
5.2 Ready to test 26
5.3 The DPOAE test 26
5.3.1 Starting the test 26
5.3.2 The DPOAE test 27
5.3.3 DPOAE test results 28
5.4 Options in the test result screens 30
5.5 Continuing testing on the other ear 30
5.6 Viewing a patients test record 30
5.6.1 Test View 30
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5.6.2 The Test History screen 31
6 Printing 33
6.1 Printing from Alpha OAE 33
6.2 Printouts from label printer 33
7 Alpha OAE settings 35
7.1 The Settings menu 35
7.2 Probe Test 35
7.2.1 Performing the probe test 36
7.2.2 From the Settings menu 36
7.3 Test Settings 37
7.4 Time and Date setting 37
7.5 Language setting 38
7.6 Sound setting 39
7.7 Display Brightness 39
7.8 System Info 40
8 Handling Data in Alpha OAE 41
8.1 Function buttons 41
8.2 General buttons 41
8.3 Deleting data 42
8.3.1 Deleting one test 42
8.3.2 Deleting all tests 42
9 Maintenance and Cleaning 45
9.1 The probe tip and probe body 45
9.1.1 Cleaning and disinfecting the probe tip 45
9.1.2 Cleaning the probe body 46
9.1.3 Probe calibration 47
9.2 Eartips 47
9.3 Cleaning Alpha OAE 47
9.3.1 Cleaning and disinfecting the test cavity 47
9.4 Battery safety and maintenance 48
9.4.1 Safety information 48
9.4.2 Increasing service life 48
9.4.3 Disposal of old batteries 48
App. 1 Standards and Safety 51
App. 1.1 Alpha OAE symbols 51
App. 1.2 Accessory symbols 51
App. 1.3 Docking station symbols 52
App. 1.4 Warning notes - Alpha OAE 52
App. 1.5 Warranty 53
App. 1.6 Repair, after-sales service and regular checks 53
App. 1.6.1 Declaration 54
App. 1.7 Manufacturer 54
App. 1.7.1 Responsibility of the manufacturer 54
App. 2 Status and Error Messages 55
App. 2.1 Device related messages 55
App. 2.2 Usage and test related messages 55
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App. 3 Technical Specifications 57
App. 3.1 Accessories 57
App. 3.1.1 Standard accessories 57
App. 3.1.2 Optional accessories 57
App. 3.2 Measurement techniques 57
App. 3.2.1 DPOAE 57
App. 3.3 Device 57
App. 3.3.1 Dimensions 58
App. 3.3.2 Weight 58
App. 3.3.3 Display 58
App. 3.3.4 Keypad 58
App. 3.3.5 Sound 58
App. 3.3.6 Language settings 58
App. 3.3.7 Memory 58
App. 3.3.8 Connectors 58
App. 3.3.9 Real time clock 59
App. 3.3.10 Data interfaces 59
App. 3.3.11 Transport and storage environment 59
App. 3.3.12 Operating environment 59
App. 3.3.13 Warm-up time 59
App. 3.3.14 Disposal 59
App. 3.3.15 Standards 60
App. 3.4 Power supply and battery 60
App. 3.5 1077 docking station 60
App. 3.5.1 Printer/modem interface 60
App. 3.5.2 DC power input 61
App. 3.5.3 Power adapter 61
App. 3.6 OAE probe 61
App. 3.6.1 Probe cable 61
App. 3.6.2 Dimensions 61
App. 3.6.3 Weight 61
App. 3.6.4 Eartips 61
App. 3.7 Device class 61
App. 3.8 Notes on EMC (Electromagnetic Compatibility) 62
Index 65
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6 Otometrics - MADSEN Alpha OAE

1 Introduction
Thank you for purchasing the Alpha OAE handheld Otoacoustic Emissions Screener.
Note •This manual is your guide to the use and maintenance of Alpha OAE. We
strongly recommend that you read it carefully before using Alpha OAE for the first time.
We also recommend that you take particular note of the cleaning and maintenance instructions.
Failure to use and maintain Alpha OAE correctly may void your warranty.
Alpha OAE is a fast, reliable, easy to use, and lightweight hearing screener.
Alpha OAE provides for easy navigation using its touch screen function.
Alpha OAE uses DPOAE (Distortion Product Otoacoustic Emissions) technology. Otoacoustic Emissions measure cochlear
mechanics and indicate whether the cochlea is functioning correctly or not. Emission strength usually decreases with age
or hearing impairment.
1.1 Printing
For printing instructions see Printing ►33.
Alpha OAE
With Alpha OAE you can print test results from a label printer connected to Alpha OAE.
You can connect a label printer via a special printer cable supplied with the label printer.
For reasons of safety, testing cannot be carried out as long as the label printer with external power supply is connected to
Alpha OAE. During this time the test function is automatically disabled.
An optional docking station is also available with Alpha OAE. You can place Alpha OAE in the docking station and print to a
label printer connected to the docking station.
1.2 Intended Use
The Type 1077 device is indicated for use in the recording and automated analysis of human physiological data (screening
auditory brainstem responses and/or otoacoustic emissions) necessary for the diagnosis of auditory and hearing-related dis-
orders. The device is especially indicated for use in the screening of infants to determine hearing loss.
Distortion Product Otoacoustic Emissions and Transient Evoked Otoacoustic Emissions: The Type 1077 DPOAE module
and TEOAE module can be used for patients of all ages, from children to adults, including infants and geriatric patients. It
is especially indicated for use in testing individuals for whom behavioral audiometric results are deemed unreliable, such
as infants, young children, and cognitively impaired or uncooperative adults.
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1 Introduction

Auditory Brainstem Response: The Type 1077 ABR module is especially intended for infants from 34 weeks (gestational
age) up to 6 months of age.
Type 1077 is intended to be used by qualified clinic personnel. The device is simple to operate. It does not require special
technical skills or interpretation of results by the device operator. Basic training with the device is sufficient to learn how
to operate it. Healthy newborn infants are eligible for screening 6 hours after vaginal delivery, or 24 hours after caesarean
section delivery.
There are no known contra-indications for use of Type 1077 device and accessories.
The 1077 device comes in various configurations. The Alpha OAE device, which is a 1077 device, is only available in an
OAE configuration.
Important•GNOtometricsA/S does not guarantee the accuracy of the test results or the tests themselves, if
accessories other than those supplied by GNOtometricsA/S are used for this device (i.e. eartips).
1.3 About this manual
Important•Please note that menu selections and screen shots in this manual may not reflect the configuration
of your test device.
This manual contains a description of the main functions of Alpha OAE.
We recommend that you make yourself familiar with the following issues:
Installation
Unpacking and Installation ►11, and Preparing for testing ►21 contain a full description of unpacking instructions, con-
trols and socket connections, and how to set up the device.
Safety
This manual contains information and warnings which must be followed to ensure the safe performance of Alpha OAE.
Local government rules and regulations, if applicable, should also be followed at all times.
Please see the overview of device labeling in Views of Alpha OAE ►11 and read the warning notes in Standards and
Safety ►51.
Training
It is recommended that you read this manual before you start operating Alpha OAE so that you become familiar with the
device before testing on a client.
Maintenance and cleaning
For instructions on how and when to clean Alpha OAE and accessories, please see Maintenance and Cleaning ►45.
8 Otometrics - MADSEN Alpha OAE
1 Introduction

1.4 Typographical conventions
The use of Warning, Caution and Note
For safety reasons and appropriate use of the device and/or software, the manual contains Warnings,Cautions and Notes.
These headings are used as follows:
Warning•Indicates that there is risk of death or serious injury to the user or patient.
Caution•Indicates that there is a risk of injury to the user or patient or risk of damage to data or the device.
Note •Indicates that you should take special notice.
1.4.1 Navigating this manual
Menus, icons and functions to select are shown in bold type, as for instance in:
• Press the OK button.
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1 Introduction

1 Introduction
10 Otometrics - MADSEN Alpha OAE

2 Unpacking and Installation
2.1 Unpacking
1. Unpack the device carefully.
When you unpack the device and accessories, it is a good idea to keep the packing material in which they were
delivered. If you need to send the device in for service, the original packing material will protect against damage dur-
ing transport, etc.
2. Visually inspect the equipment for possible damage.
If damage has occurred, do not put the device into operation. Contact your local distributor for assistance.
3. Check with the packing list to make sure that you have received all necessary parts and accessories. If your package is
incomplete, contact your local distributor.
2.2 Views of Alpha OAE
2.2.1 Front and rear view
A. On/Off switch
B. Touch screen display
C. Power and charging status light indicator
D. Test cavity
E. Button for opening battery compartment
F. Cover on battery compartment with serial number label
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2 Unpacking and Installation

2.2.2 Top and bottom view
Top Bottom
A. Probe socket B. Connector for label printer
2.2.3 Display
The display is a touch-screen display, where the icons and fields shown serve as buttons.
• Touch the buttons to activate a function.
Caution•Never use any type of sharp instrument on the display. If you do, reliable operation of Alpha OAE can
no longer be guaranteed.
2.2.4 Ear probe
Probe cable plug
A. Probe tip B. Probe body
C. Probe cable
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2 Unpacking and Installation

2.3 Storage
Store Alpha OAE and accessories in the soft case provided to protect the equipment from damage. See also Operating
environment ►59
2.4 Assembly
When you receive Alpha OAE, do the following before you connect the probe.
1. Insert the battery in the battery compartment. See Inserting the battery in Alpha OAE ►14.
We recommend that you charge the battery fully in the external charger (Charging the battery with the external char-
ger ►15).
2. Turn on Alpha OAE. See Switch on Alpha OAE ►17.
3. Set the date on the device. See Time and Date setting ►37.
Now you can connect the probe. See Connecting the probe ►21
2.5 Powering
Alpha OAE is powered by a rechargeable battery. The battery is charged
by the external charger supplied with Alpha OAE. See Charging the battery with the external charger ►15.
2.5.1 The battery
The battery used in Alpha OAE:
• is a rechargeable Li-Ion battery, Part no. 8-73-02400
• has a high capacity
• is low weight
• has a low rate of self discharge
• can be charged continuously
• guarantees approximately 8 hours of operating time
On delivery, the battery is charged approximately 50%.
Before you start testing, we recommend that you charge the battery fully.
Use only the battery type and charger stated in Power supply and battery ►60.
See Battery safety and maintenance ►48.
Battery Storage
If the battery is to be stored for a long time, it is recommended that it is stored with approximately 50% remaining battery
capacity and in a dry and cool place. Storing the battery in a refrigerator can be recommended.
If the battery is stored with full battery capacity and at room temperature or warmer, the battery will permanently
degrade with about 10-20% after one year.
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2 Unpacking and Installation

2.5.2 Inserting the battery in Alpha OAE
1. Push the button of the battery compartment upwards.
The battery compartment pops out.
2. If needed, remove the battery.
3. Place a new, charged battery in the compartment.
– Hold the battery so that the arrow with the text “Insert this direction” points
downwards towards the bottom of the compartment.
4. Close the compartment.
2.5.3 Battery status
• The battery symbol is shown in the top right corner of the display, enabling you to view the status of the battery at all
times.
• When less than 25% of the battery capacity remains, we recommend that you change the battery and recharge it as
soon as possible.
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2 Unpacking and Installation

• When the battery level drops below 10%, test results can be viewed, but testing is no longer possible.
Symbol Remaining battery capacity
100 - 75% Battery is fully charged.
75 - 50%
50 - 25%
25 - 10% Battery should be charged.
10 - 0% Battery is very low and testing is not possible.
If the necessary minimum voltage should drop, Alpha OAE switches off automatically. Recharge or change the battery
as soon as possible.
2.5.4 Charging the battery with the external charger
Caution•Use only the charger supplied by GNOtometricsA/S.
The battery for Alpha OAE is charged by an external charger.
See the charger manufacturer’s documentation for specifications and instructions for use.
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2 Unpacking and Installation

2 Unpacking and Installation
16 Otometrics - MADSEN Alpha OAE

3 Getting Started with Alpha OAE
In the following, you will find quick instructions for getting started with Alpha OAE:
• Switching on Alpha OAE
You will find in-depth instructions for preparing and testing in:
•Preparing for testing ►21
•Testing with Alpha OAE ►25
3.1 Switch on Alpha OAE
1. Switch on Alpha OAE: Press the On/Off switch.
A start-up screen is shown, while Alpha OAE performs a self-test.
A. On/Off switch
3.1.1 Power-saving mode and automatic power-off
If you do not use Alpha OAE for a certain period of time, Alpha OAE will first switch to power-saving mode, and finally
switch off automatically.
• When Alpha OAE is in power-saving mode, the display goes black and the power indicator lights up green.
• Simply touch the screen to reactivate Alpha OAE.
3.1.2 The Alpha OAE screens
• Buttons are described in
–Function buttons ►41
–General buttons ►41
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3 Getting Started with Alpha OAE

Navigating the screens in Alpha OAE
The screens in Alpha OAE are usually divided into 3 or 4 main areas:
A. The title bar, showing
– the time
– the screen title
– the battery status
B. The main screen where you will typically find
– test screens
C. The function bar with available function buttons
D. The footer with available buttons for main functions such as
– returning to the previous screen,
– accessing help,
– returning to the Home screen.
3.1.3 The Home menu
The Home menu
From the Home menu, you can select all main functions in Alpha OAE.
• See The DPOAE test ►26
• See Viewing a patients test record ►30.
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3 Getting Started with Alpha OAE

• See Printing ►33.
• See Deleting data ►42.
• See Alpha OAE settings ►35.
• See Selecting child mode ►25.
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3 Getting Started with Alpha OAE

3 Getting Started with Alpha OAE
20 Otometrics - MADSEN Alpha OAE