MADSEN Alpha OAE Screener User Manual Rev 01

Copyrightnotice No part of this documentation orprogram 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 byGN 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/Sreserves the right to make changes at any time without notice. Versionrelease date 2013-12-04 Technicalsupport Please contact your supplier.

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Otometrics - MADSEN Alpha OAE

Table of Contents 1

Introduction 1.1 Printing 1.2 Intended Use 1.3 About this manual 1.4 Typographical conventions 1.4.1 Navigating this manual

7 7 7 8 9 9

2

Unpacking and Installation 2.1 Unpacking 2.2 Views of Alpha OAE 2.2.1 Front and rear view 2.2.2 Top and bottom view 2.2.3 Display 2.2.4 Ear probe 2.3 Storage 2.4 Assembly 2.5 Powering 2.5.1 The battery 2.5.2 Inserting the battery in Alpha OAE 2.5.3 Battery status 2.5.4 Charging the battery with the external charger

11 11 11 11 12 12 12 13 13 13 13 14 14 15

3

Getting Started with Alpha OAE 3.1 Switch on Alpha OAE 3.1.1 Power-saving mode and automatic power-off 3.1.2 The Alpha OAE screens 3.1.3 The Home menu

17 17 17 17 18

4

Preparing for testing 4.1 Preparing Alpha OAE 4.2 Preparing the equipment 4.2.1 Preparing the probe for testing 4.2.2 Connecting the probe 4.3 Preparing the test environment 4.4 Preparing the patient 4.4.1 Fitting the eartip on the probe 4.4.2 Inserting the probe with eartip in the patient’s ear canal

21 21 21 21 21 22 22 23 23

5

Testing with Alpha OAE 5.1 Selecting child mode 5.2 Ready to test 5.3 The DPOAE test 5.3.1 Starting the test 5.3.2 The DPOAE test 5.3.3 DPOAE test results 5.4 Options in the test result screens 5.5 Continuing testing on the other ear 5.6 Viewing a patients test record 5.6.1 Test View

25 25 26 26 26 27 28 30 30 30 30

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5.6.2 The Test History screen

4

31

6

Printing 6.1 Printing from Alpha OAE 6.2 Printouts from label printer

33 33 33

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Alpha OAE settings 7.1 The Settings menu 7.2 Probe Test 7.2.1 Performing the probe test 7.2.2 From the Settings menu 7.3 Test Settings 7.4 Time and Date setting 7.5 Language setting 7.6 Sound setting 7.7 Display Brightness 7.8 System Info

35 35 35 36 36 37 37 38 39 39 40

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Handling Data in Alpha OAE 8.1 Function buttons 8.2 General buttons 8.3 Deleting data 8.3.1 Deleting one test 8.3.2 Deleting all tests

41 41 41 42 42 42

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Maintenance and Cleaning 9.1 The probe tip and probe body 9.1.1 Cleaning and disinfecting the probe tip 9.1.2 Cleaning the probe body 9.1.3 Probe calibration 9.2 Eartips 9.3 Cleaning Alpha OAE 9.3.1 Cleaning and disinfecting the test cavity 9.4 Battery safety and maintenance 9.4.1 Safety information 9.4.2 Increasing service life 9.4.3 Disposal of old batteries

45 45 45 46 47 47 47 47 48 48 48 48

App. 1 Standards and Safety App. 1.1 Alpha OAE symbols App. 1.2 Accessory symbols App. 1.3 Docking station symbols App. 1.4 Warning notes - Alpha OAE App. 1.5 Warranty App. 1.6 Repair, after-sales service and regular checks App. 1.6.1 Declaration App. 1.7 Manufacturer App. 1.7.1 Responsibility of the manufacturer

51 51 51 52 52 53 53 54 54 54

App. 2 Status and Error Messages App. 2.1 Device related messages App. 2.2 Usage and test related messages

55 55 55

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App. 3 Technical Specifications App. 3.1 Accessories App. 3.1.1 Standard accessories App. 3.1.2 Optional accessories App. 3.2 Measurement techniques App. 3.2.1 DPOAE App. 3.3 Device App. 3.3.1 Dimensions App. 3.3.2 Weight App. 3.3.3 Display App. 3.3.4 Keypad App. 3.3.5 Sound App. 3.3.6 Language settings App. 3.3.7 Memory App. 3.3.8 Connectors App. 3.3.9 Real time clock App. 3.3.10 Data interfaces App. 3.3.11 Transport and storage environment App. 3.3.12 Operating environment App. 3.3.13 Warm-up time App. 3.3.14 Disposal App. 3.3.15 Standards App. 3.4 Power supply and battery App. 3.5 1077 docking station App. 3.5.1 Printer/modem interface App. 3.5.2 DC power input App. 3.5.3 Power adapter App. 3.6 OAE probe App. 3.6.1 Probe cable App. 3.6.2 Dimensions App. 3.6.3 Weight App. 3.6.4 Eartips App. 3.7 Device class App. 3.8 Notes on EMC (Electromagnetic Compatibility) Index

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57 57 57 57 57 57 57 58 58 58 58 58 58 58 58 59 59 59 59 59 59 60 60 60 60 61 61 61 61 61 61 61 61 62 65

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1 Introduction

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 disorders. 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, controls 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.

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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

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Otometrics - MADSEN Alpha OAE

2 Unpacking and Installation

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 during 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

Otometrics - MADSEN Alpha OAE

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

2.2.3

B.

Connector for label printer

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

12

B. C.

Probe body 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 charger ► 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

14

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.

Otometrics - MADSEN Alpha OAE

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

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Otometrics - MADSEN Alpha OAE

3 Getting Started with 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 •

3.1

Testing with Alpha OAE ► 25

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.

3.1.2

•

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.

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

3.1.3

–

returning to the previous screen,

–

accessing help,

–

returning to the Home screen.

The Home menu The Home menu From the Home menu, you can select all main functions in Alpha OAE.

18

•

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

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Otometrics - MADSEN Alpha OAE

4 Preparing for testing

4

Preparing for testing

4.1

Preparing Alpha OAE

4.2

•

Follow the instructions in Getting Started with Alpha OAE ► 17.

•

See Testing with Alpha OAE ► 25 on how to proceed with the specific tests.

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 ► 35.

Caution • Insert only disinfected probe tips in the test cavity. See Cleaning and disinfecting the test cavity ► 47.

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 double arrow on the probe plug with the arrow in the grey bordering around the socket of Alpha OAE. 3. Gently insert the probe plug into the probe socket on top of Alpha OAE. 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.

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