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 The Alpha OAE+ docking station 1.2 Printing 1.3 Intended Use 1.4 About this manual 1.5 Typographical conventions 1.5.1 Navigating this manual

7 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 The docking station 2.2.4 Display 2.2.5 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 Powering the docking station 2.5.5 Charging the battery from the docking station 2.5.6 Charging the battery with the external charger 2.6 Installing the MADSEN Alpha OAE+ Printing Tool

11 11 11 11 12 12 13 14 14 14 14 14 15 16 16 17 17 18

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 3.2 Patient handling in Alpha OAE+ 3.2.1 Adding a new patient 3.2.2 Finding a patient 3.2.3 Editing patient data

19 19 19 19 20 21 21 22 23

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

25 25 25 25 25 26 26 27 27

5

Testing with Alpha OAE+ 5.1 Selecting child mode

29 29

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3

5.2 5.3

5.4 5.5 5.6 5.7 5.8

Ready to test The DPOAE test 5.3.1 Starting the test 5.3.2 The DPOAE test 5.3.3 DPOAE test results Options in the test result screens Adding comments to a test 5.5.1 Adding a standard comment 5.5.2 Viewing comments Continuing testing on the other ear Handling test results Viewing a patients test record 5.8.1 Test View 5.8.2 The Test View screen

6

Quick Start tests 6.1 Performing a Quick Start test 6.2 Handling Quick Start test results

41 41 41

7

Printing 7.1 Printing from Alpha OAE+ 7.2 Printouts from label printer

45 45 47

8

Alpha OAE+ settings 8.1 The Settings menu 8.2 Probe Test 8.2.1 Performing the probe test 8.2.2 From the Settings menu 8.3 Test Settings 8.4 Time and Date setting 8.5 Language setting 8.6 Sound setting 8.7 Display Brightness 8.8 System Info

49 49 49 50 51 51 52 53 53 54 54

9

Handling Data in Alpha OAE+ 9.1 Entering data in Alpha OAE+ 9.1.1 Using the keypad 9.2 Function buttons 9.3 General buttons 9.4 Deleting data 9.4.1 Deleting one patient 9.4.2 Deleting one test 9.4.3 Deleting all patients

55 55 55 56 57 57 57 58 59

10 Maintenance and Cleaning 10.1 The probe tip and probe body 10.1.1 Cleaning and disinfecting the probe tip 10.1.2 Cleaning the probe body 10.1.3 Probe calibration 10.2 Eartips 10.3 Cleaning Alpha OAE+ 10.3.1 Cleaning and disinfecting the test cavity

4

29 30 31 32 33 35 36 36 36 36 37 38 38 38

61 61 61 62 63 63 63 63

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10.4 Battery safety and maintenance 10.4.1 Safety information 10.4.2 Increasing service life 10.4.3 Disposal of old batteries

64 64 64 64

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 Warning notes - docking station App. 1.6 Warranty App. 1.7 Repair, after-sales service and regular checks App. 1.7.1 Declaration App. 1.8 Manufacturer App. 1.8.1 Responsibility of the manufacturer

67 67 67 68 68 69 69 69 70 70 70

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

71 71 71

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 PC interface App. 3.5.2 Printer/modem interface App. 3.5.3 DC power input App. 3.5.4 Power adapter App. 3.6 OAE probe App. 3.6.1 Probe cable App. 3.6.2 Dimensions App. 3.6.3 Weight

73 73 73 73 73 73 73 73 74 74 74 74 74 74 74 74 75 75 75 75 75 75 76 76 76 76 77 77 77 77 77 77

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5

6

App. 3.6.4 Eartips App. 3.7 Device class App. 3.8 Notes on EMC (Electromagnetic Compatibility)

77 78 79

Index

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Otometrics - MADSEN Alpha OAE+

1 Introduction

1

Introduction 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

The Alpha OAE+ docking station The Alpha OAE+ is supplied with a docking station, which provides for:

1.2

•

easy recharging of the battery

•

printing from a document printer

•

creating a PDF with test results

•

printing from a label printer

Printing For printing instructions see Printing ► 45.

Alpha OAE+ You can place Alpha OAE+ in the docking station and send reports to a PC. You can then print the reports from the PC. If you have an optional label printer, it can be connected to the docking station and then you can print test results from the label printer.

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 disorders. The device is especially indicated for use in the screening of infants to determine hearing loss.

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1 Introduction

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.

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).

1.4

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 ► 25 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 ► 67.

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 ► 61.

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1 Introduction

1.5

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.

1.5.1

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

A. Probe socket

2.2.3

Bottom

B.

Docking Station connectors

The docking station

Front indicators POWER Lit when the mains power supply to the docking station is on.

Lit when data is being transferred: • during transfer of a report to the PC •

during printing from label printer

USB Lit when docking station is connected to the PC via a USB cable.

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2 Unpacking and Installation

Rear sockets PC/USB Socket for USB connection to the PC

Printer/Modem Socket for printer/modem connection

Socket for power adapter

2.2.4

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.

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2 Unpacking and Installation

2.2.5

Ear probe

Probe cable plug

A. Probe tip

2.3

B. C.

Probe body Probe cable

Storage Store Alpha OAE+ and accessories in the soft case provided to protect the equipment from damage. See also Operating

environment ► 75

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+ ► 15. We recommend that you charge the battery fully by placing Alpha OAE+ in the docking station (Charging the battery from the docking station ► 17). 2. Turn on Alpha OAE+. See Switch on Alpha OAE+ ► 19. 3. Set the date on the device. See Time and Date setting ► 52. Now you can connect the probe. See Connecting the probe ► 25

2.5

Powering Alpha OAE+ is powered by a rechargeable battery. The battery is charged: • when Alpha OAE+ is placed in the docking station. See Charging the battery from the docking station ► 17. •

2.5.1

by the Alpha OAE+ external charger (optional accessory). See Charging the battery with the external charger ► 17.

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%.

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2 Unpacking and Installation

Before you start testing, we recommend that you charge the battery fully. Use only the battery type, docking station and charger stated in Power supply and battery ► 76 and 1077 docking station ► 76. See Battery safety and maintenance ► 64.

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.

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.

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2 Unpacking and Installation

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.

•

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

Powering the docking station The Alpha OAE+ docking station is powered through an adapter from the mains outlet.

Warning • In order to comply with the safety requirements for a medical device system, connection to the docking station must always be done outside the patient area (min. 1.5 meters/5 ft from the patient).

You will find an adapter plug kit when you unpack Alpha OAE+. The adapter plug kit contains a range of adapter plugs you can choose from to fit your mains outlet.

Connecting to the mains supply 1. Select the adapter plug appropriate to your mains outlet and fit it on the adapter. 2. Connect the adapter to the docking station and the mains supply, and switch on the mains supply. The POWER indicator will light up green.

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2 Unpacking and Installation

Caution • Electrical equipment must be positioned so that there is easy access to disconnect the power supply from the mains.

Disconnecting from the mains supply To disconnect Alpha OAE+ docking station from the mains supply, simply remove the adapter plug from the mains outlet.

2.5.5

Charging the battery from the docking station The battery in Alpha OAE+ charges automatically when you place Alpha OAE+ in the docking station. 1. Place Alpha OAE+ in the docking station. The light indicator on the front of Alpha OAE+ will light up.

Front light indicator Green

•

Fully charged

Orange - steady

•

Charging

Orange - flashing

•

During start-up

•

When there is a battery error, for example: –

No battery inserted

–

Battery inserted incorrectly

–

Defect battery

Charging a fully discharged battery from the docking station takes approximately:

2.5.6

80% charged

4½ hours

Fully charged

6 hours

Charging the battery with the external charger

Caution • Use only the charger supplied by GN Otometrics A/S.

The battery for Alpha OAE+ can be charged by an external charger (optional accessory). See the charger manufacturer’s documentation for specifications and instructions for use.

Otometrics - MADSEN Alpha OAE+

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2 Unpacking and Installation

2.6

Installing the MADSEN Alpha OAE+ Printing Tool You can install the MADSEN Alpha OAE+ printing tool in order to print reports from MADSEN Alpha OAE+ via the docking station. The printing tool allows you to configure the way that reports will be printed.

To install the tool 1. Insert the installation media for the MADSEN Alpha OAE+ Printing Tool in the PC to which you will attach the docking station. 2. If the installation wizard does not start automatically, then browse to d:Alpha OAE+ (where d: denotes the location disk drive or USB port - of the installation media) and double-click Alpha OAE+<version number>.exe. 3. The installation wizard helps you configure the printing tool, step-by-step. –

Configure how you want the tool to behave when you create a report from Alpha OAE+. There are the following options:

Save PDF file - If you select this option, the file dialog will be shown each time you create a report from MADSEN Alpha OAE+. You can then select a folder and enter a filename for the report.

Save PDF file to pre-defined folder - When you select this option, you must enter a folder where all reports will be saved. A filename will generated automatically for each report.

Show Print preview - If you select this option, the Test Report Preview window will open when you create a report from MADSEN Alpha OAE+. From the Test Report Preview window, you can view, save or print the report.

Show Printer selection dialog - If you select this option, the Print dialog will open when you create a report, and then you can select a printer.

Print to default printer - If you select this option, then reports that you create from MADSEN Alpha OAE+ will automatically be sent to the printer that is set up as default for the PC. –

Select the paper size for your reports.

–

Select a logo to print on your reports. Here you can select either a jpg or png file.

4. When you have reached the final page of the wizard, click Finish. To change the settings at a later time, you can locate the MADSEN Alpha OAE+ Printing Tool in Add or Remove Programs and then click Change.

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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+ •

Adding new patients

•

Finding patients

•

Editing patient data

You will find in-depth instructions for preparing and testing in: • Preparing for testing ► 25 •

3.1

Testing with Alpha OAE+ ► 29

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 •

Main instructions for data entry screens are described in –

•

Entering data in Alpha OAE+ ► 55.

Buttons are described in –

Function buttons ► 56

–

General buttons ► 57

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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

–

patient buttons

–

keypad for entering data, etc.

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+.

20

•

See Quick Start tests ► 41.

•

See Finding a patient ► 22.

•

See Adding a new patient ► 21.

Otometrics - MADSEN Alpha OAE+