User manual - MADSEN Alpha OAE

MADSEN Alpha OAE Screener

User Manual

Doc. No. 7-50-1370-US/04

Part No. 7-50-13700-US

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© 2015, 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.

Registered trademarks and Trademarks

MADSEN Itera II,MADSEN OTOflex 100, OTOsuite,AURICAL FreeFit, AURICAL Visible Speech, MADSEN Astera², MADSEN Xeta, ICS

Chartr 200 VNG/ENG, ICS Chartr EP, OTOcam 300, MADSEN AccuScreen, MADSEN AccuLink,ICS AirCal, AURICAL Aud, AURICAL HIT,

ICS Impulse, OTObase and MADSEN Capella² are either registered trademarks ortrademarks of GN Otometrics A/S.

Versionrelease date

12-16-2015

Technicalsupport

Please contact your supplier.

2 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

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

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

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

5

Testing with Alpha OAE

5.1

Selecting Child Mode

5.2

Ready to test

5.3

The DPOAE test

5.3.1 DPOAE test protocol

5.3.2 Starting the test

5.3.3 The DPOAE test

5.3.4 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

Otometrics - MADSEN Alpha OAE

17

17

18

18

17

17

17

19

19

14

14

14

14

15

23

25

27

27

27

21

21

22

22

22

22

10

11

11

11

10

10

9

9

9

9

11

12

12

13

6

6

6

7

8

8

3

4

5.6.1 Test View

5.6.2 The Test History screen

6

Printing

6.1

Printing from Alpha OAE

6.2

Printouts from label printer

7

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

8

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

9

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 built-in 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

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

App. 2 Status and Error Messages

App. 2.1 Device related messages

App. 2.2 Usage and test related messages

47

48

48

48

45

45

45

46

46

47

49

49

49

42

43

43

43

40

40

40

41

42

42

44

44

37

37

37

38

38

38

27

28

29

29

29

32

33

33

33

31

31

31

34

35

35

36


App. 3 Technical Specifications

App. 3.1 Accessories

App. 3.2 Measurement techniques

App. 3.3 Device

App. 3.4 Power supply and battery

App. 3.5 1077 docking station

App. 3.6 OAE probe

App. 3.7 Device class

App. 3.8 Notes on EMC (Electromagnetic Compatibility)

Index

53

54

54

55

56

51

51

51

51

59

Otometrics - MADSEN Alpha OAE 5

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.

1.1

1.2

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.

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.

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.

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 adults.


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.

When the device is used to screen infants, they should be asleep or in a quiet state at the time of screening.

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 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 ► 9 , and

Preparing for testing ► 17

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 ► 9

and 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.

Maintenance and cleaning

For instructions on how and when to clean Alpha OAE and accessories, please see

Maintenance and Cleaning ► 40

.


1 Introduction

1.4

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 precautionary 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.

1.4.1

Navigating this manual

Menus, icons and functions to select are shown in bold type, as for instance in:

• Press the

OK

button.


2 Unpacking and Installation

2

2.1

2.2

2.2.1

Unpacking and Installation

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.

Views of Alpha OAE

Front and rear view

A.

B.

C.

On/Off switch

Touch screen display

Power and charging status light indicator

D.

E.

F.

Test cavity

Button for opening battery compartment

Cover on battery compartment with serial number label



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.

C.

Probe body

Probe cable



2.3

2.4

2.5

2.5.1

Storage

Store Alpha OAE and accessories in the soft case provided to protect the equipment from damage. See also Operating environment in Technical Specifications.

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 charger ► 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

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

.

The battery

The battery used in Alpha OAE:

• is a rechargeable Li-Ion battery

• 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 ► 53 .

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.



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

12

• 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.



2.5.4

• 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%

10 - 0%

Battery should be charged.

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.

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.


3 Getting Started with Alpha OAE

3

3.1

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:

•


•

Testing with Alpha OAE ► 21

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

3.1.2

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.

The Alpha OAE screens

• Buttons are described in

–

–

Function buttons ► 37

General buttons ► 37


3.1.3

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.

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 .



• See

Printing ► 29 .

• See

Deleting data ► 38

.

• See

Alpha OAE settings ► 31

.

• See

Selecting Child Mode ► 21

.


4 Preparing for testing

4

4.1

4.2

Preparing for testing

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.

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

4.2.2

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.

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.



4.3

4.4

Disconnecting the probe

Caution

•

Do not pull the plug by the cable when you disconnect the probe. Instead, pull the sleeve of the grey connector.

To disconnect do not twist the plug. 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.

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 completely 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.

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 result of the test.



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 appropriate 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.

4.4.2

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 .

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 downwards, 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.



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.


5

5.1

Testing with Alpha OAE

Before you begin to test:

1. Decide on which ear you wish to perform the test.

2. Do as described in


.

Selecting Child Mode

On the

Home

ing testing.

screen, you can select Child Mode to display a child-friendly screen dur-

• Press the

Child Mode

button to activate or deactivate the function.

5 Testing with Alpha OAE

When

Child Mode

is activated, an animated car is displayed on the screen during testing instead of the data that is normally displayed.



5.2

Ready to test

• On the

Home

screen, press the

Test

button corresponding to the ear you wish to test.

5.3

5.3.1

5.3.2

The DPOAE test

DPOAEs are responses generated by the inner ear to a two-tone stimulation. For each frequency that is tested, a pair of tones is presented. The frequency of one of the tones presented is called F1 and the level of that tone is called L1. The other tone is called F2 and its level is L2.

DPOAE test protocol

The test is conducted by measuring the frequencies in decreasing order; the results are displayed with the frequencies increasing from left to right. The frequencies tested are:

5 kHz

4 kHz

3 kHz

2 kHz

The L1/L2 pair is 65/55 dB SPL. Only

F2

is shown.

Starting the test

Calibration and speaker test are performed before the actual test starts.

Calibration

If the probe does not fit correctly, adjust the position of the probe.


Speaker test

The calibration is followed by a speaker test to make sure that the two speakers function correctly.


The test starts automatically when calibration is completed.

“Incomplete” message

If the message

Incomplete

appears:

• Refit the probe and make sure that it fits correctly.

• Press the

Start

button to restart the test.

If the calibration fails due to large ear canal volume (for example, due to a PE tube in the patient's ear), and if the

Manual start

option is enabled in

Test Settings

, then a double arrow appears on the result screen. Press the double-arrow to start the measurement with maximum calibrated output levels.

5.3.3

The DPOAE test

The test as it progresses is shown on the display. The test ear and the frequency currently being tested is shown at the top of the screen.

If

Child Mode

is activated, an animated car is displayed on the screen during testing.

(See

Selecting Child Mode ► 21

.)

The progress bar under the animated picture is green if the test conditions are good and it is red if there is too much noise. Noise can come from the environment or the patient.

The bar gets longer as each test frequency in the sequence is completed.



If

Child Mode

is not activated, a bar chart is displayed. See the

Test details

table below for a description of the bar chart and other data displayed.

24

• If needed, press the

Stop

button to stop the test. The test will be saved as an incomplete test.

The test frequencies are

• 5 kHz

• 4 kHz

• 3 kHz

• 2 kHz where 5 kHz is tested first.

The default

Pass/Clear Response

and

Refer/No Clear Response

criterion is 3/4. The test stops automatically if 3 frequencies reach a


result or 2 frequencies receive a


result.

Test details

Shows which ear is being tested.

Bar chart

Noise

Excessive Noise

Noise is above 41 dB SPL for more than 50% of the test duration for the frequency.

Registered DPOAE response: Frequency passed

DPOAE frequency being tested or referred

The height of the bars represents the noise/response amplitude.

The test frequencies are shown below the bar chart.

DPOAE

Response at current test frequency.



5.3.4

Test details

Noise

Current noise level. Make sure the noise level is as low as possible. The noise bar turns red when the noise level is over 41 dB

SPL.

Test duration - Regular DPOAE

Approximately 10 seconds on patients with normal hearing under quiet conditions, but highly dependent on test conditions in general.

DPOAE test results

In Child Mode, when a test is completed, the Reward screen is displayed, regardless of the test result. This screen shows an animated bunch of balloons floating up to the sky. The outcome of the test is then displayed on the

Test result

screen.If

Child Mode is not activated, the

Test result

screen is displayed immediately after the test is completed.

See

Options in the test result screens ► 27

for a description of the buttons available.

Pass/Clear Response

A single frequency


is determined by a statistical algorithm based on weighted averaging, which ensures high-sensitivity detection. A

Pass/Clear

Response

result for a single frequency indicates that the patient has normal outer hair cell function in the corresponding frequency region of the cochlea at the time of testing.

The complete test is terminated successfully with a


if DPOAEs could be registered for at least 3 out of 4 frequencies.

Note

•

Retro-cochlear hearing loss cannot be detected by DPOAE testing.



Refer/No Clear Response

A


result indicates that in at least 2 frequency bands out of

4, no significant DPOAE response could be detected.

The DPOAE result specifies each frequency tested. This facilitates decisions concerning further procedures. A


at a single frequency indicates near to normal outer hair cell function in the corresponding frequency region of the cochlea.

The common reasons for non-detection are noisy test conditions or a poor probe fit. In

DPOAEs this is especially true for the lowest frequencies. Therefore, low frequency


with high frequency


is a strong indicator that test conditions were not optimal. If this is the case, it is recommended that you improve test conditions and repeat the test.

Inconclusive test

If it is not possible to achieve a Pass result and:

1. the patient has a large ear canal volume and the test was started with the

Manual

Start

(double-arrow) button after a failed calibration,

or

2. the test environment is too noisy, then the test result may be

Inconclusive

.

In the case of a large ear canal volume (due to PE tubes or perforation of the ear drum) it may not be possible for the L1/L2 to reach the required stimulus levels. Adequate stimulus levels are crucial in order to achieve an accurate response. In this case, the result is

Inconclusive

, and a message indicates that there was a large ear canal volume or a poor probe fit.

If noise exceeds acceptable levels for more than half of the test time, the result is

Inconclusive

and a message indicates that the noise was too high.

Incomplete test

If the test was stopped, an error message is shown.

The result screen appears differently from the one shown, if the test failed or was aborted during calibration.



5.4

5.5

5.6

5.6.1

Options in the test result screens

Test result options

Print results

See

Printing ► 29

.

Test Other Ear

Starts test in the other ear.

Start

If you wish to repeat the test, press the

Start

button.

OK

Press to return to the

Home

screen.

Continuing testing on the other ear

1. Before you continue testing the other ear, check to make sure that the probe is clean. See also

Maintenance and Cleaning ► 40

.

2. If needed, reposition the patient so that you can test the other ear and insert the probe in the new test ear.

3. Press the

Test Other Ear

button in the test results screen.

The test starts automatically.

Viewing a patients test record

A patient screened by Alpha OAE is either given a


, a


, or an

Inconclusive

test result.

• If the result is a


, no further action is required.

• If the result is a


, it is recommended that you retest the patient. If the patient is given yet another


, this patient should be referred for further testing.

• If the result is

Inconclusive

, it is recommended that you retest the patient in a quieter environment. If the result is still

Inconclusive

, then the patient could be considered for further testing.

See also

DPOAE test results ► 25

Test View

You can view tests from the

Home

screen.

1. On the

Home

screen, press the

Test View

button.

This will take you to a list of tests.



5.6.2

The Test History screen

The

Test History/Print

screen shows the tests that have been made.

The tests are numbered and listed according to date, with the most recent tests at the top of the list.

1. To view more tests, if available, press the arrow buttons to scroll up or down in the list.

The

Test History/Print

screen shows you information about

– on which ear the test was made.

– the date and time on which the test was made.

The test results

•

Pass/Clear Response

Testing successful (OAE present)

•

•

•

Refer/No Clear Response

OAE criterion not reached

Inconclusive

OAE criterion not reached and noisy test conditions or large cavity volume detected.

Incomplete

2. To view the individual test results, press the result icon. This will take you to a test result screen displaying the test you wish to view.

3. To print the individual test results, press the

Print

icon next to the test you wish to print.

For a description of the individual test result types, see

DPOAE test results ► 25

.


6 Printing

6

6.1

6.2

Printing

You can print complete results on a label printer connected directly to Alpha OAE. 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.

Printing from Alpha OAE

Warning

•

Before you make any printouts, make sure that the patient is not in contact with Alpha OAE by removing the probe from the patient's ear.

Warning

•

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

Note

•

Testing is not possible when Alpha OAE is placed in the docking station or connected to the printer.

Note

•

Do not switch off Alpha OAE while printing is in progress. Doing so may result in distorted test data.

Note

•

If the label printer is not connected or if it is switched off, an error message appears on the screen.

Note

•

Use only the label printer recommended. Alpha OAE automatically recognizes the label printer.

Note

•

Do not print from MADSEN Alpha OAE when the label printer status light indicates "Cooling down" or

"Buffer overflow."

1. Connect the label printer cable to Alpha OAE.

2. Switch on the printer.

To print individual test results, select

Test View

from the

Home

screen and press the

Print

icon next to the test you wish to print.

Printouts from label printer

The printouts show:

• Test type

• Left and/or right ear result, date and time


6 Printing

• At the top of the print-out you will find additional fields for entering:

– Last Name

– First Name

– ID

– Date of Birth

– Examiner

Pass/Clear Response Refer/No Clear Response

Legend

Legend

L

R

P

R

N

• Left ear

• Right ear

• Pass

• Refer

• Inconclusive due to Noise


7 Alpha OAE settings

7

7.1

Alpha OAE settings

You can configure your Alpha OAE from the Alpha OAE

Settings

menu.

Alpha OAE

From the Alpha OAE

Settings

menu you can:

• test the probe

• change the setting to delete old tests automatically

• change time and date settings

• change the language setting

• change the sound settings

• change the brightness of the display

• view system information

The Settings menu

From the

Settings

menu, you can change the basic settings of Alpha OAE, and see information about the hardware and the software installed.

1. Press the

Settings

button on the

Home

screen.

From the

Settings

menu you can access the settings available in Alpha OAE.

7.2

Probe Test

Every day before you start testing on patients, you should test the probe to make sure that it functions correctly.

Caution

•

Make sure that the probe tip has been cleaned and disinfected before you insert it in the test cavity.

See

Cleaning and disinfecting the built-in test cavity ► 43

.

You can start the probe test in two ways:

• Simply by inserting the probe in the test cavity of Alpha OAE (see

Performing the probe test ► 32

).



7.2.1

• From the

Settings

menu (for example, to restart the test or to test the probe using an external test cavity).

Performing the probe test

1. Insert the probe tip without eartip in the test cavity.

The test starts automatically.

Note

•

The probe test does not start automatically e.g. when a patient is being created.

If the probe functions correctly, the message

Probe OK

appears.

32

If the probe does not function correctly, the message

Probe failed

appears.

You will also see a list of possible errors.

2. Press the

OK

button to confirm the test result.

If needed, repeat the test.


7.2.2

7.3

7.4

From the Settings menu

1. Insert the probe tip without eartip in the test cavity on the device, or in an external test cavity.

2. Press the

Probe Test

button on the

Settings

screen.

3. For more information, see

Performing the probe test ► 32

.

Test Settings

On the

Test Settings

screen, you can determine what happens when the device memory becomes full.

The

Delete old tests

option determines what happens after 50 tests have been stored and the memory on Alpha OAE is full.

If you select the


check box, then the oldest test will automatically be deleted to make room for the newest test.

If you do not select the


check box, then a message will be displayed when the memory is full, and you will be required to manually delete old tests. (See

Deleting data ► 38

.)

The

Manual start

option determines whether you are able to manually start a measurement after calibration has failed. If the

Manual start

option is enabled and calibration fails due to large ear canal volume (for example, due to PE tubes in the child's ears), then a double arrow appears on the result screen. You can then press the doublearrow to start the measurement with maximum calibrated output levels.

Time and Date setting

1. Press the

Time and Date

button on the

Settings

screen.

You can set the date in the upper part of the screen and the time in the lower part.

Note

•

If you leave the Time and Date screen by pressing the OK button, the setting of seconds is set to zero.

2. Press the arrows to select the day (DD), month (MM), year (YYYY), hours (HH) and minutes (MIN).




3. Press the

Tool

button to change the date and time formats.

–

Date format

Select from the list how the date setting is to be shown on the screen.

–

Time format

Select from the list how the time setting is to be shown on the screen.

7.5

Language setting

1. Press the

Language

button on the

Settings

screen.

2. To change the language on Alpha OAE, press the button with the preferred language.

Note

•

Your screen showing the available languages may not appear as the one shown.



7.6

Sound setting

1. Press the

Sound

button on the

Settings

screen.

You can switch sounds on/off for button strokes and test results by pressing the relevant button.

7.7

Sound on

–

Key click

Pressing a button will produce a sound (a click)

–

Result sound

A


or


sound is heard at the end of the test.

Sound off

Shows that the sound is disabled.

Display Brightness

1. Press the

Display Brightness

button on the

Settings

screen.

To change the brightness of the display, press the buttons on either side of the green bar.

Note

•

A high level of brightness will influence the power consumption of the device.

– Darkens the display

– Brightens the display

– Press the Default button to use the default setting for the display brightness.



7.8

System Info

1. Press the

System Info

button on the

Settings

screen to view information regarding:

– Firmware release

– HW version and Serial number

– Next MADSEN Alpha OAE service date

– Connected probe

– Next service date for the connected probe

– Memory usage


8

8.1

Handling Data in Alpha OAE

Function buttons

Available functions are shown in the function bar of the Alpha OAE screens.

These functions vary from screen to screen.

• To perform these functions, simply press the relevant function button.

Function buttons

• Scroll to see more/next page

8.2

General buttons

Available main functions are shown in the footer bar of the Alpha OAE screens.

• To perform these functions, simply press the relevant button.

8 Handling Data in Alpha OAE



General buttons

• Return to previous screen

• Help

• Go to the Home screen

• OK/Confirm/Save/Go to next field/Go to next screen

8.3

8.3.1

Deleting data

Deleting one test

1. To delete one single test, press the

Delete

button on the

Home

screen.

This takes you to the

Delete

menu.

2. Press the

Single test

button.

This takes you to the

Test History/Delete

screen to select one or more tests to delete.

8.3.2

3. Press the

Delete

button to the right of the test you wish to delete.

You will be prompted to confirm that you wish to delete this test.

4. When you have deleted all the tests you wish to delete, press the

Home

button to go to the

Home

screen.

Deleting all tests

1. To delete all tests, press the

Delete

button on the

Home

screen.


This will take you directly to the

Delete

menu.

2. Press the

All tests

button.

You will be prompted to confirm that you wish to delete all tests.

All tests will be deleted.



9 Maintenance and Cleaning

9

9.1

Maintenance and Cleaning

The probe tip and probe body

Be sure to follow any established infection control procedures for the setting in which you are working.

Warning

•

Never place the probe tip in the ear canal without using a clean eartip.

The probe tip usually does not come into contact with the skin or secretion from the ear canal, as it is covered by the eartip, but you should check the channels in the probe tip every time you have used the probe. Even small amounts of cerumen or vernix can block the probe channels or be deposited on the probe tip.

Warning

•

If needed, replace the probe tip with a spare one.

Note

•

Probe tips should be disposed of according to local regulations.

9.1.1

Cleaning and disinfecting the probe tip

Please remove the ear probe from the patient’s ear and separate the probe tip from the disposable eartip before cleaning.

Caution

•

You should always comply with local hygienic standards.

See

Hygienic precautions ► 18

.

The probe tip

– Remove the probe tip from the probe.



– Use the cleaning wire to clean the sound channels of the probe tip from the rear.

Note

•

Remember to clean the cleaning wire when it protrudes from the probe tip.

When you have finished using the cleaning wire, then remember to disinfect the cleaning wire in accordance with local procedures.

Disinfecting procedures for the probe tip

The probe tip material is highly resistant to a wide range of temperature and chemical influences.

In order to disinfect the probe tip, perform the following:

• After cleaning, immerse the probe tip in a bath of 70-90% ethyl or isopropyl alcohol for 10-30 minutes contact time.

When you have disinfected the probe tip, rinse it thoroughly in regular water.

If your established infection control procedure dictates autoclaving, make sure that the probe tip has not been deformed by the autoclaving process.

Make sure that the sound channels are completely dry before you fit the tip back onto the probe body. If needed, use a spare probe tip.

9.1.2

Cleaning the probe body

Important

•

For periodical cleaning of the probe body, contact your authorized service department.

Caution

•

The probe body contains sensitive components. Never clean the sound apertures in the probe body mechanically or with liquids. Doing so may cause damage to the probe.

Caution

•

Even the slightest amount of moisture may dissolve any residual cerumen and contaminate the sensitive parts in the body of the probe.

– Use a moist tissue with alcohol for regular surface cleaning.

Caution

•

No part of the ear probe should be subjected to ultrasonic cleaning solutions or machines.



9.1.3

9.2

Probe calibration

The Alpha OAE probe is calibrated at the factory prior to delivery. This is why there may not be a full year to the next calibration date stated on the calibration certificate when you receive Alpha OAE.

The first time you connect the probe to Alpha OAE and perform a test, the calibration date will be set so that there is one year to the next calibration.

To view the next calibration date, select

Settings > System info

. Before you perform the first test, the date field will be blank.

Calibration frequency

The probe should be calibrated annually by authorized service personnel at an authorized workshop.

Eartips

Eartips are disposable and should not be cleaned.

Note

•

Eartips should be disposed of according to local regulations.

9.3

Cleaning Alpha OAE

• Before cleaning, switch off Alpha OAE and unplug it from any external power source.

• Unplug the probe from Alpha OAE.

• Use a tissue moistened with cleaning fluid to clean the surface of the device.

To maximize the housing lifetime, avoid the following chemicals:

• Isopropyl, 70%

• Ethanol, >40% concentration

• Formaldehyde

• Dichloro-meta-xylenol 5-10%

If disinfecting Alpha OAE is considered necessary, some suitable alternatives are cleaning agents that contain:

• Hydrogen peroxide, 3%, 30%

• Peracetic acid 0.5-5%

• Sodium hypochlorite 1-10%

• Glutaraldehyde 2-5%

• Ortho-phthalaldehyde (a.k.a. OPA) 0.5-2%

• Chlorhexidingluconat 2-4%

Caution

•

Always make sure that no moisture enters the probe, the sockets (data interface connector and probe plugs) or the test cavity.



Caution

•

Never immerse Alpha OAE into water or other cleaning solutions.

Caution

•

Use of cleaning agents other than those recommended in the user manual can cause damage to the device (for example, stress cracks in molded plastic).

9.3.1

9.4

9.4.1

Cleaning and disinfecting the built-in test cavity

If needed, use a tissue moistened with any of the recommended disinfectant agents described in section 11.4 to clean the entry surface of the test cavity.

Caution

•

Make sure that no liquid enters the test cavity.

If the test cavity has been contaminated with debris from the probe tip, make sure that the test cavity cannot be used, for instance by sticking a piece of tape across the entry hole, and contact your authorized service department for cleaning and/or replacement of the test cavity.

Battery safety and maintenance

Safety information

Explosion hazard

Warning

•

Keep the battery away from heat or open fire, and do not throw it into fire, as this may cause the battery to explode.

Warning

•

The battery used in this device may present a risk of fire or chemical burn if mistreated. Do no disassemble, heat above 60°C (140°F) or incinerate.

• Incorrect handling, applying excessive charging current or reversing the poles can overcharge or destroy the battery.

• Do not open, alter or dismantle the battery.

• Do not place the battery in contact with metal objects.

• The terminals must under no circumstances be short-circuited.



9.4.2

9.4.3

Increasing service life

• Use only the battery type and charger stated in

Power supply and battery ► 53 .

• Charge the battery at room temperature whenever possible.

• Do not drop the battery or expose it to sharp impact.

• Store in a cool, dry place.

• Keep the battery's terminals clean. Clean with a soft cloth if necessary.

Battery renewal

The battery capacity will gradually degrade by many charging/discharging cycles and by ageing. We recommend that you fit the instrument with a new battery approximately every 12 to 18 months.

The need for renewing the battery depends on the usage pattern and the battery capacity needed.

Disposal of old batteries

Note

•

Li-Ion batteries can be recycled!

Caution

•

Dispose of used battery promptly.

Caution

•

Keep away from children.

Caution

•

Do not disassemble and do not dispose of in fire.

Environmental protection

• When the Li-Ion battery loses its capacity to be charged, make sure that it is disposed of according to local environmental regulations, or return it to your dealer.




This manual contains information and warnings that must be followed to ensure safe performance of Alpha OAE. Local government rules and regulations, if applicable, should be followed at all times.

App. 1.1

Alpha OAE symbols

Symbol Definition

Consult user manual for warnings and cautions.

Complies with Type BF requirements of IEC60601-1.

MEDICAL - General Medical Equipment as to electrical shock, fire and mechanical hazards only in accordance with UL 60601-1, first edition, 2003 CAN/CSA-22.2 No. 601.1-M90.

Complies with Medical Devices Directive 93/42/EEC and RoHS Directive (2011/65/EC).

Electronic equipment covered by the Directive 2002/96/EC on waste electrical and electronic equipment

(WEEE).

All electrical and electronic products, batteries, and accumulators must be taken to separate collection at the end of their working life. This requirement applies in the European Union. Do not dispose of these products as unsorted municipal waste.

You can return your device and accessories to Otometrics, or to any Otometrics supplier. You can also contact your local authorities for advice on disposal.

App. 1.2

Accessory symbols


Non sterile product.

Do not reuse.



App. 1.3

Docking station symbols


Consult user manual for warnings and cautions.

Suitable for direct current only.

Complies with Medical Devices Directive 93/42/EEC and RoHS Directive (2011/65/EC).

Electronic equipment covered by the Directive 2002/96/EC on waste electrical and electronic equipment

(WEEE).

All electrical and electronic products, batteries, and accumulators must be taken to separate collection at the end of their working life. This requirement applies in the European Union. Do not dispose of these products as unsorted municipal waste.

You can return your device and accessories to Otometrics, or to any Otometrics supplier. You can also contact your local authorities for advice on disposal.

App. 1.4

Warning notes - Alpha OAE

Warning

•

The following conditions or practices might present possible injury or danger to the patient and/or the user:

• Do not connect any external device (e.g., printer) to Alpha OAE during testing.

• If Alpha OAE is used during surgery, the probe and connectors must not touch conductive items including ground.

• The probe socket is intended to connect the ear probe to Alpha OAE. No other device may be connected to this socket.

• Avoid accidental contact between connected but unused applied parts and other conductive parts including those connected to protective earth.

• Do not store or operate Alpha OAE at temperatures and humidity exceeding those stated in Technical Specifications,

Operating environment.

• Do not use the instrument in the presence of flammable anesthetics (gases).

• No parts may be eaten, burnt, or in any other way used for purposes other than audiometry.

• The instrument and any device to be connected which has its own power supply should be turned off before any connections are established.

• We recommend that an annual calibration be performed on Alpha OAE and probe. Furthermore, we recommend that calibration be performed if the equipment has suffered any potential damage.

• For safety reasons, accessories connected to the equipment's outlet sockets must be supplied with the system.



• Disposable accessories, such as eartips, should not be reused and must be replaced between patients to prevent crossinfection.

• This class of equipment is allowed in domestic establishments when used under the jurisdiction of a health care professional.

• Alpha OAE’s RF emissions are very low and are not likely to cause any interference in nearby electronic equipment, but negative effect or loss of functionality of other local devices may occur if they are placed in close vicinity of Alpha

OAE.

• When assembling an electro-medical system, the person carrying out the assembly must take into account that other connected equipment which does not comply with the same safety requirements as this product may lead to a reduction in the overall safety level of the system.

• In the United States of America, Federal law restricts this device to sale by or on the order of a licensed physician.

App. 1.5

Warranty

Alpha OAE is guaranteed against original defects in material and workmanship. It is also guaranteed to perform in accordance with the manufacturer's specifications for a full 2 years from the date of purchase.

The warranty does not apply to the battery, to wear parts and disposable items.

This warranty only applies to those instruments purchased from authorized distributors or representatives. The purchaser must return the instrument to an authorized distributor or representative and bear the cost of shipping.

This warranty does not cover breakage or failure due to tampering, misuse, neglect, accidents, modification or shipping and is void if the instrument is not used in accordance with the manufacturer's instructions.

Please return your instrument to your local distributor or representative for warranty attention!

Important

•

The warranty will become void if the probe cleaning instructions are not strictly adhered to. If the probe is not cleaned regularly as directed in the instructions, cerumen may result in blockage of the probe, where sensitive components are contained and could be damaged.

App. 1.6

Repair, after-sales service and regular checks

If Alpha OAE as such is found to be defective or in some way varies from the manufacturer's specifications, an authorized dealer will repair, replace or re-calibrate the instrument at no cost to the purchaser while Alpha OAE is within the warranty period.

Service and repair of electro-medical equipment should only be carried out by the equipment manufacturer or by authorized representatives.

The manufacturer reserves the right to disclaim all responsibility for the operation safety, reliability and performance of equipment serviced or repaired by other parties.

Following repair, a qualified electronics engineer should verify the safety of all equipment.

Calibration should be performed annually by suitably qualified personnel using the appropriate equipment.



App. 1.6.1

Declaration

All devices of the type Alpha OAE should be checked and calibrated annually through a service center authorized by the manufacturer.

App. 1.7

Manufacturer

GN Otometrics A/S

Hoerskaetten 9, 2630 Taastrup

Denmark

( +45 45 75 55 55

7 +45 45 75 55 59 www.otometrics.com

App. 1.7.1

Responsibility of the manufacturer

The manufacturer is to be considered responsible for effects on safety, reliability, and performance of the equipment only if:

• All assembly operations, extensions, re-adjustments, modifications or repairs are carried out by the equipment manufacturer or personnel authorized by the manufacturer.

• The electrical installation to which the equipment is connected complies with EN/IEC requirements.

• The equipment is used in accordance with the instructions for use.

The manufacturer reserves the right to disclaim all responsibility for the operating safety, reliability and performance of equipment serviced or repaired by other parties.




App. 2.1

Device related messages

Error message

Low battery voltage

The real time clock data is invalid. Please set time and date.

Hardware failure

Real time clock error

Memory error

FLASH runtime error

Codec malfunction

Cause

• The battery charge is low.

• The battery charge is low.

• The real time clock power backup has been completely drained.

Solution

• Recharge Alpha OAE or replace the battery with a spare.

• Recharge Alpha OAE or replace the battery with a spare.

• Set the time and date: Select

Settings > Date and Time

.

• Contact your supplier.

• Self test error.


• Self test error: Invalid test data has been found in flash memory.




• Try to delete all test data and restart the device. If the message re-appears, contact your supplier.

• Restart the device. If the message re-appears, contact your supplier.

App. 2.2

Usage and test related messages

Error message

Measurement memory full.

Measurement cannot be carried out.

Probe FAILED

Cause

• Alpha OAE's measurement memory is full.

• The probe did not pass the test.

There may be several causes:

– the probe tip is blocked

– the test cavity is blocked

– the probe is damaged

Too much noise • Testing environment is too noisy.

Solution

• Delete tests.

• Make sure that the probe tip is clean and that the channels are not blocked.

• Make sure that the test cavity is not blocked by e.g., dust, lint or such.

• Replace the probe with a spare one and carry out the probe test to establish if the probe is damaged.

• Reduce noise (talking, mobile phones, etc.).



Error message

Stimulus high

Stimulus low

Paper feed error

Cause

• The probe has a poor fit in the ear canal.

• The probe is not in the ear canal.

• The probe has a poor fit in the ear canal.

• The probe tip is blocked.

• The labels are not adjusted correctly in the label printer or there is a paper jam.

Solution

• Try to refit the probe.

• Try to refit the probe. If the problem persists, clean the probe tip or replace it with a spare.

• Re-adjust the labels and remove possible blocking of paper feed.




App. 3.1

Accessories

Standard accessories and optional accessories may vary from country to country - please consult your local distributor.

Standard accessories

Starter kit

OAE probe

External battery charger

User Manual

Battery

Cleaning cloth

Transportation bag

Optional accessories

Label printer with printer cable

Probe

Docking station, including power adapter

App. 3.2

Measurement techniques

DPOAE

Evaluation method:

Stimulus:

Available test frequencies:

Default test frequencies:

Default test level:

Test display:

Result display:

SNR:

Minimum Amplitude:

Noise-weighted phase statistics

Primary tone pair, F2/F1 = 1.24

F2 = 2, 3, 4 and 5 kHz

F2 = 2, 3, 4 and 5 kHz (


at 3 out of 4)

L1/L2 = 65/55 dB SPL

DP-Gram, DPOAE level, noise level

Overall


or


, DP-Gram with DPOAE and noise level.

6 - 8 dB

- 5 dB or -10 dB

App. 3.3

Device

MADSEN Alpha OAE is type 1077 from GN Otometrics A/S.

Dimensions

Approx.

200 x 73 x 34 mm (7.9 x 2.9 x 1.3 inches)



Weight

Approx.

240 g (8.5 oz) excluding battery

280 g (9.9 oz) including battery

Display

Type:

Dimensions:

Resolution:

Color, TFT, touch screen with adjustable LED backlight

89.4 mm (3.5 inches)

240 x 320 pixels

Keypad

Resistive touch screen (can be used with gloves)

Sound

Built-in speaker for key click and


and


sounds

Language settings

Up to 7 user selectable languages available in selected language package

Memory

Test memory capacity:

Connectors

OAE probe connector:

Max. 50 tests

14 pin ODU Medisnap - For OAE Probe

Real time clock

Integrated real time clock for time-stamping of measurements. The clock is automatically synchronized with PC clock when docked.

Accuracy:

Backup:

Max. deviation 12 minutes/year

Min. 7 days, when battery is removed from unit

Data interfaces

Label printer: RS232 interface to Label Printer

Transport and storage environment

Temperature range:

Humidity range:

Air pressure

-20 - +60°C (-4 - 140°F)

10 - 90 % rel., non-condensing

500 hPa to 1040 hPa



Operating environment

Mode of operation:

Temperature range:

Humidity range:

Air pressure

Continuous

10 - 40°C (50 - 104°F)

30 - 90 % rel., non-condensing

600 hPa* to 1040 hPa

*At locations where the normal air pressure is below 800 hPa (at altitudes of more than 2000 meters), it is recommended to recalibrate the OAE probe.

Warm-up time

< 20 seconds.

Note

•

Should be extended if MADSEN Alpha OAE has been stored in a cold environment.

Disposal

MADSEN Alpha OAE can be disposed of as normal electronic waste, according to WEEE and local regulations.

Standards

Otoacoustic emissions:

Patient Safety:

EMC:

EN 60645-6, Type 2

• EN 60601-1, Internally Powered, Type BF, IPXO

• U2601-1; CAN/CSA-C22.2 NO 601.1-90,

• IEC 60601-2-26

• IEC 60601-2-40

EN 60601-1-2

App. 3.4

Power supply and battery

Device

Supply voltage: Nom. 3.70 V,

Max. 4.20 V,

Min. 3.20 V (measured with device load)

1.5 W while measuring Maximum battery power consumption:

Estimated battery life:

Battery level indicator:

8 hours of continuous use (based on a typical use scenario. Actual use can influence the battery life time.)

5-step battery level indicator



Battery

Caution

•

Use only rechargeable battery supplied by GN Otometrics A/S, Part no. 8-73-02400. Use of any other battery may present a risk of fire or explosion.

Battery type: Rechargeable Li-ion 3.7 V/1800 mAh (6.7 Wh), fully charged

App. 3.5

1077 docking station

The docking station is an optional accessory.

Printer/modem interface

Interface type:

Connector type:

RS232

6-pol Mini Din

DC power input

Input voltage: 5 V DC ±5%

Max. power consumption when Alpha OAE is docked: 5 VA (5 V, 1.0 A)

Max. power consumption when Alpha OAE is not docked: 0.25 VA (5 V, 50 mA)

Power adapter

Input voltage/range:

Output voltage:

Output current:

Mains plug types:

100-240 V AC, 50-60 Hz

5.0 V DC

Minimum 1.0 A

US, UK, Europe and Australia

App. 3.6

OAE probe

Probe cable

Flexible, shielded cable, approx. length: 150 cm (approx. 59 inches)

Dimensions

Probe body:

Probe tip:

Weight

Probe incl. probe tip:

20 mm Ø x 23 x 11 mm (0.8 inch Ø x 0.9 inch x 0.43 inch)

3.3 mm Ø x 10 mm (0.13 inch Ø x 0.4 inch)

Approx. 4.5 g


Eartips

Silicone tree tip:

Foam tip:

5 - 8 mm, Blue

7 - 11 mm, Orange

11 - 15 mm, Red

Small, 11 mm, Orange

Medium, 12 mm, Orange

Large, 14 mm. Orange

App. 3.7

Device class

II a (according to Council Directive 93/42/EEC Appendix IX)




App. 3.8

Notes on EMC (Electromagnetic Compatibility)

• MADSEN Alpha OAE is part of a medical electrical system and is thus subject to special safety precautions. For this reason, the installation and operating instructions provided in this document should be followed closely.

• Portable and mobile high-frequency communication devices, such as mobile phones, may interfere with the functioning of MADSEN Alpha OAE.

Guidanceand manufacturer's declaration - electromagnetic emissions for all equipment and systems

MADSEN Alpha OAE is intended for use in the electromagnetic environment specified below. The user of MADSEN Alpha OAE should ensure that it isused in such an environment.

Emissionstest Compliance Electromagnetic environment - guidance

RF emissions

CISPR 11

RF emissions

CISPR 11

Group 1

Class B

MADSEN Alpha OAE uses RF energy only for its internal function. Therefore, its RF emissionsare very low and are not likely to cause any interference in nearby electronic equipment.

MADSEN Alpha OAE is suitable for use in all environments, including domestic environments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Guidanceand manufacturer's declaration - electromagnetic immunity for all equipment and systems


Immunitytest IEC 60601 test level

Compliancelevel Electromagnetic environment - guidance

Electrostatic discharge

(ESD)

IEC 61000-4-2

+/- 6 kV contact

+/- 8 kV air

+/- 6 kV contact

+/- 8 kV air

Floors should bewood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Power frequency

(50/60 Hz) magnetic field

IEC 61000-4-8

3A/m 3A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Note

•

U

T is the AC mains voltage prior to application of the test level.



Guidanceand manufacturer's declaration - electromagnetic immunity - for equipment and systems that are NOT life-supporting


Immunitytest IEC 60601 test level

Compliancelevel Electromagnetic environment - guidance

Radiated RF

IEC 61000-4-3

150 kHzto 80 MHz outsideISM bands a

3V/m

80MHz to 2.5 GHz

3V/m

Portableand mobile RF communications equipment should be used no closer to any part of

MADSEN Alpha OAE, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance: d = 1.2

d = 1.2

for 80MHz to 800 MHz d = 2.3

for 80MHz to 2.5 GHz, where

P

is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).

Field strengthsfrom fixed RF transmitters, as determined by an electromagnetic site survey, a should beless than the compliance level in each frequency range.

b

Interference may occur in the vicinity of equipment marked with this symbol:

Note 1: At 80 MHz and 800 MHz the separation distance for the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a. Field strengthsfrom fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,amateur radio, AM and FMradio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should beconsidered. If the measured field strength in the location in which MADSEN Alpha OAE is used exceeds the applicable

RF compliance level above, the MADSEN Alpha OAE should be observed to verify normal operation. If abnormal performance isobserved, additional measures might be necessary, such asreorienting or relocating MADSEN Alpha OAE.

b. Over the frequency range 150 kHzto 80MHz, field strengths should beless than 3 V/m.



Recommended separation distances between portable and mobile RF communications equipment and MADSEN Alpha OAE

The MADSEN Alpha OAEis intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the MADSEN Alpha OAE can help prevent electromagnetic interference by maintaining aminimum distance between portable and mobile RF communications equipment (transmitters) and the MADSEN Alpha OAEas recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter

W

Separation distance according to frequency of transmitter m

150 kHz to 80 MHz d = 1.2

80 MHzto 800 MHz d = 1.2

800 MHz to 2.5 GHz d = 2.3

0.01

0.1

1

10

100

0.12

3.8

12

0.38

1.2

0.12

3.8

12

0.38

1.2

0.23

7.3

23

0.73

2.3

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where

P

is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note 1

:At 80 MHzand 800 MHz the separation distancefor the higher frequency range applies.

Note 2

:These guidelinesmay not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.


Index

A

Accessory symbols 45

After-sales service 47

Alpha OAE

printing 6

starting 14 switch on 14

Assembling the device 11

Automatic power off 14

B

Battery 11

changing 12

disposal 44 extending life 44

maintenance 43

operating time 11

recharging 13

status 12

status symbols 13

storage 11 type 11

Brightness, display 35

Buttons

function bar buttons 37 general 37

C

Changing battery 12

Cleaning 40

device 42

probe tip 40

test cavity 43

Connecting probe to Alpha OAE 17

D

Data

deleting data 38

Delete a test 38

Delete all tests 38


Index

Device

bottom view 10

cleaning 42

front view 9

preparing for testing 17

rear view 9

technical specifications 51

top view 10

Display 10

error messages 49

Display brightness 35

Disposal

device 45

eartips 42

old battery 44

DPOAE

test 23

test procedure 22

test results 25

E

Ear probe

view 10

Eartips

disposal 42

fitting on probe 19

maintenance 42

Environment

preparing test 18

Equipment preparation 17

Error message 49 device related 49 usage and test related 49

F

Function buttons 37

G

General buttons 37

I

Inserting probe in ear 19

L

Labelprinter 29

59

Index

Language settings 34

M

Maintenance 40

battery 43

cleaning device 42

cleaning test cavity 43

disposal of batteries 44

eartips 42

increasing battery life 44

probe 40 probe body 40

probe calibration 42

probe tip 40

Manufacturer 48

Messages on display 49

P

Patient

preparing 18

Pinna 18

Power

power off automatic 14 saving mode 14

Powering Alpha OAE 11

Preparing

device for testing 17

fitting eartip on probe 19

for testing 17

patient 18

Preparing equipment 17

Printing 29

from Alpha OAE 6

types of printout 29

Probe

body 10 cable 10

cleaning tip 40

connecting to Alpha OAE 17

fitting eartip 19

maintenance 40

prepare for testing 17

tip 10 view 10

60

Probe body

maintenance 40

Probe calibration

maintenance 42

Probe tip

cleaning 40 maintenance 40

R

Recharging battery 13

Remove

battery 12

test 38

Repair 47

Results

test view 27

S

Safety information 43, 45

Safety symbols 45

Screens

Home menu 15

Service life

increasing 44

Settings 31

brightness 35

from the Settings menu 33

language 34

performing probe test 32

probe test 31

sound 35

system info 36

the Settings menu 31

time and date 33

Sharp instruments, using on

display 10

Sound setting 35

Starting Alpha OAE 14

Status messages 49

Storing Alpha OAE 11

Switching on Alpha OAE 14

System info 36

T

Technical specifications 51


Index

Test

DPOAE procedure 22

options in screens 27

prepare probe for 17

ready to 22

test view 27

Test cavity

cleaning 43

Test environment 18

Test result

DPOAE 25

Test View 27

screen 28

Testing

preparing for 17

Time and date settings 33

U

Unpacking 9

V

Views

device top 10 display 10 ear probe 10

front 9 rear 9

W

Warning notes 46

Warranty repair 47


No results