otometrics MADSEN Alpha OAE User manual

MADSEN Alpha OAE Screener
User Manual
Doc. No. 7-50-1370-US/05
Part No. 7-50-13700-US

Copyright notice
© 2014,2018Natus Medical Denmark A/S. All rights reserved. ® Otometrics, the OtometricsIcon, AURICAL, MADSEN, ICS
and HORTMANN are registered trademarks of Natus Medical Denmark A/S in the U.S.A. and/or other countries.
Version release date
04-24-2018 (183899)
Technical support
Please contact your supplier.
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Table of Contents
1 Introduction 6
1.1 Brief description 6
1.2 Printing 6
1.3 Intended Use 6
1.4 Physical operating principle 7
1.5 About this manual 7
1.6 Typographical conventions 8
1.6.1 Navigating this manual 8
2 Unpacking and Installation 9
2.1 Unpacking 9
2.2 Overview of Alpha OAE 9
2.2.1 Front and rear of Alpha OAE 9
2.2.2 Top and bottom of AccuScreen 10
2.2.3 Display 10
2.2.4 Ear probe 10
2.3 Storage 11
2.4 Assembly 11
2.5 Powering 11
2.5.1 The battery 11
2.5.2 Inserting the battery in Alpha OAE 12
2.5.3 Battery status 12
2.5.4 Charging the battery with the external charger 13
3 Getting Started with Alpha OAE 14
3.1 Switch on Alpha OAE 14
3.1.1 Power-saving mode and automatic power-off 14
3.1.2 The Alpha OAE screens 14
3.1.3 The Home menu 15
4 Preparing for testing 17
4.1 Preparing Alpha OAE 17
4.2 Preparing the equipment 17
4.2.1 Preparing the probe for testing 17
4.2.2 Connecting the probe 17
4.3 Preparing the test environment 18
4.4 Preparing the patient 18
4.4.1 Fitting the eartip on the probe 19
4.4.2 Inserting the probe with eartip in the patient’s ear canal 19
5 Testing with Alpha OAE 21
5.1 Selecting Child Mode 21
5.2 Ready to test 21
5.3 The DPOAE test 22
5.3.1 DPOAE test protocol 22
5.3.2 Starting the test 22
5.3.3 The DPOAE test 23
5.3.4 DPOAE test results 24
5.4 Options in the test result screens 26
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5.5 Continuing testing on the other ear 27
5.6 Viewing a patients test record 27
5.7 Test View 27
5.8 The Test History screen 27
6 Printing 29
6.1 Printing from Alpha OAE 29
6.2 Printouts from label printer 29
7 Alpha OAE settings 31
7.1 The Settings menu 31
7.2 Probe Test 31
7.2.1 Performing the probe test 32
7.2.2 From the Settings menu 33
7.3 Test Settings 33
7.4 Time and Date setting 33
7.5 Language setting 34
7.6 Sound setting 35
7.7 Display Brightness 35
7.8 System Info 36
8 Handling Data in Alpha OAE 37
8.1 Function buttons 37
8.2 General buttons 37
8.3 Deleting data 38
8.3.1 Deleting one test 38
8.3.2 Deleting all tests 38
9 Maintenance and Cleaning 40
9.1 The probe tip and probe body 40
9.1.1 Cleaning and disinfecting the probe tip 40
9.1.2 Cleaning the probe body 41
9.1.3 Probe calibration 42
9.2 Eartips 42
9.3 Cleaning Alpha OAE 42
9.3.1 Cleaning and disinfecting the built-in test cavity 43
9.4 Battery safety and maintenance 43
9.4.1 Safety information 43
9.4.2 Increasing service life 44
9.4.3 Disposal of old batteries 44
App. 1 Standards and Safety 45
App. 1.1 Alpha OAE symbols 45
App. 1.2 Accessory symbols 45
App. 1.3 Docking station symbols 46
App. 1.4 Warning notes - Alpha OAE 46
App. 1.5 Warranty 47
App. 1.6 Repair, after-sales service and regular checks 47
App. 1.6.1 Declaration 48
App. 1.7 Manufacturer 48
App. 1.7.1 Responsibility of the manufacturer 48
App. 2 Status and Error Messages 49
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App. 2.1 Device related messages 49
App. 2.2 Usage and test related messages 49
App. 3 Technical Specifications 51
App. 3.1 Accessories 51
App. 3.2 Measurement techniques 51
App. 3.3 Device 51
App. 3.4 Power supply and battery 53
App. 3.5 1077 docking station 54
App. 3.6 OAE probe 54
App. 3.7 Device class 55
App. 3.8 Notes on EMC (Electromagnetic Compatibility) 56
Index 59
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1 Introduction
1.1 Brief description
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.
1.2 Printing
For printing instructions see Printing ►29.
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.
1.3 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.
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 res-
ults are deemed unreliable, such as infants, young children, and cognitively impaired adults.
Auditory Brainstem Response:
The Type 1077 ABR module is especially intended for infants from 34 weeks (gestational age) up to 6 months of age.
When the device is used to screen infants, they should be asleep or in a quiet state at the time of screening.
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1 Introduction

The device is intended for use by audiologists, ENT's and other healthcare professionals.
Note •There are no known contra-indications for use of Type 1077 device and accessories.
Note •The 1077 device comes in various configurations. The Alpha OAE device, which is a 1077 device, is only avail-
able in an OAE configuration.
Important • Natus Medical Denmark A/S does not guarantee the accuracy of the test results or the tests themselves,
if accessor-ies other than those supplied by Natus Medical Denmark A/S are used for this device (i.e. eartips).
1.4 Physical operating principle
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.
1.5 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 ►9, and Preparing for testing ►17 describes how to unpack Alpha OAE, prepare and connect
cables, and 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 Overview of Alpha OAE ►9and read the warning notes in Standards and
Safety ►45.
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.
To obtain a free printed copy of the user documentation, contact Otometrics (www.otometrics.com).
Maintenance and cleaning
For instructions on how and when to clean Alpha OAE and accessories, please see Maintenance and Cleaning ►40.
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1 Introduction

1.6 Typographical conventions
The use of Warning, Caution and Note
To draw your attention to information regarding safe and appropriate use of the device or software, the manual uses pre-
cautionary statements as follows:
Warning •Indicates that there is a 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.
1.6.1 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

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 Overview of Alpha OAE
2.2.1 Front and rear of Alpha OAE
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 of AccuScreen
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 in Technical Specifications.
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 ►12.
We recommend that you charge the battery fully in the external charger (Charging the battery with the external char-
ger ►13).
2. Turn on Alpha OAE. See Switch on Alpha OAE ►14.
3. Set the date on the device. See Time and Date setting ►33.
Now you can connect the probe. See Connecting the probe ►17
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 ►13.
2.5.1 The battery
The battery used in Alpha OAE:
• is a Lithium-Ion rechargeable battery
• has a high capacity
• is lightweight
• 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%. We recommend to charge the battery fully before starting to test.
Use only the battery type, docking station and charger stated in Power supply and battery ►53 and 1077 dock-
ing station ►54.
See Battery safety and maintenance ►43.
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% The battery is fully charged.
75 - 50%
50 - 25%
25 - 10% The battery should be charged.
10 - 0% The 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 Natus Medical Denmark 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

3 Getting Started with Alpha OAE
In the following, you will find quick instructions for how to use Alpha OAE:
• Switching on Alpha OAE
You will find detailed instructions for preparing and testing in:
•Preparing for testing ►17
•Testing with Alpha OAE ►21
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 ►37
–General buttons ►37
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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 ►22
• See Viewing a patients test record ►27.
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3 Getting Started with Alpha OAE

• See Printing ►29.
• See Deleting data ►38.
• See Alpha OAE settings ►31.
• See Selecting Child Mode ►21.
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3 Getting Started with Alpha OAE

4 Preparing for testing
4.1 Preparing Alpha OAE
• Follow the instructions in Getting Started with Alpha OAE ►14.
• See Testing with Alpha OAE ►21 on how to proceed with the specific tests.
4.2 Preparing the equipment
Every day before you start testing on patients, you should test the probe to make sure that it functions correctly. See
Probe Test ►31.
Caution •Insert only disinfected probe tips in the test cavity. See Cleaning and disinfecting the built-in test cavity ►
43.
4.2.1 Preparing the probe for testing
Inspect the probe for deterioration (color changes, surface changes) of the reusable probe parts before every usage. If
deterioration occurs, contact your distributor.
4.2.2 Connecting the probe
1. Place Alpha OAE face down.
2. Align the ridge on the probe plug with the notch in the grey-bordered socket on the top end of Alpha OAE.
3. Gently insert the probe plug into the probe socket. The plug does not require force to be inserted properly.
Disconnecting the probe
Caution •Do not pull the plug by the cable when you disconnect the probe. Instead, pull the sleeve of the grey con-
nector.
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4 Preparing for testing

When disconnecting the plug, do not twist it. Instead, hold the sleeve of the plug and release it by pulling it straight out of
the socket.
The probe will not be released if you pull anywhere else than on the sleeve of the plug.
4.3 Preparing the test environment
Physical environment
• Make sure that the test environment is as quiet as possible. The quieter the room is, the more accurate and quick
your testing will be.
• Check that testing is not being done under an air conditioner or in front of a fan or ventilator.
• Check that there are no mobile phones in the vicinity, people talking etc.
Hygienic precautions
• Be sure to follow any established infection control procedures for the setting in which you are working.
• Clean probe body, probe cable and probe plug before each patient or if surface is visibly contaminated.
• Use a sterile alcohol wipe to clean the surfaces and wait until the probe body, probe cable and probe plug are com-
pletely dry.
Note •A sterile alcohol wipe typically contains isopropyl alcohol 70%. It is important to have the disinfectant in
contact with the surface for the time period specified by the disinfectant manufacturer to ensure its effectiveness.
• Always use new eartips.
4.4 Preparing the patient
General preparations of the patient
1. Position the patient so that you can easily access the ear to be tested.
2. Grasp the pinna and gently pull back and slightly away from the patient's head.
3. Look into the ear canal.
4. Inspect the ear canal to make sure it is clear of cerumen or debris as this may affect the res-
ult of the test.
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4 Preparing for testing

4.4.1 Fitting the eartip on the probe
1. Select an eartip that fits the patient's ear canal. You may have to try out a number of sizes in order to select the appro-
priate size.
2. Gently push the eartip onto the probe tip until it rests firmly against the base of the probe. It is much easier to attach
and remove the eartip if you turn it gently. When you do so, make sure that you hold the probe by the probe body
and not by the cable.
Note •Accurate testing is only guaranteed if you use the eartips provided.
Note •The eartip can be used for both ears. If you suspect infection in one ear, change the eartip and clean the probe
tip, or replace it with a spare, before you continue testing on the other ear.
Warning •Using a probe with an unsuitably sized eartip or applying excessive force may irritate the ear canal.
Note •In case of a probe error, make sure that the probe tip channels are clear (see Maintenance and Cleaning ►40)
and that the probe is connected.
See also Probe Test ►31.
4.4.2 Inserting the probe with eartip in the patient’s ear canal
1. When you have fitted an eartip on the probe, gently pull the pinna back and slightly
down and insert the probe in the ear canal, with a slight pressure, twisting the probe
slightly as you insert it.
Verify visually the correct fitting.
The probe can be inserted with the probe cable pointing either upwards or down-
wards, depending on which direction fits best.
Make sure that the probe fits well. Any leakage may increase the test duration
because of sound leakage, excessive noise or both.
Attach the clip to the patient's clothing or bedding to secure the probe cable.
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4 Preparing for testing

Note •Make sure that the cable is not in contact with any vibrating surfaces during testing.
Warning •In case of ear or ear canal trauma, don’t start any measurements.
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4 Preparing for testing