advertisement
MADSEN Alpha OAE Screener
User Manual
Doc. No. 7-50-1370-US/05
Part No. 7-50-13700-US
Copyright notice
© 2014, 2018 Natus Medical Denmark A/S .
All rights reserved.
® Otometrics, the Otometrics Icon, AURICAL, MADSEN, ICS and HORTMANN are registered trademarks of Natus Medical Denmark A/S in the U.S.A.
and/or other countries.
Version release date
04-24-2018 (183899)
Technical support
Please contact your supplier.
2 Otometrics - MADSEN Alpha OAE
Table of Contents
1
1.1
1.2
1.3
1.4
1.5
1.6
2
2.1
2.2
2.2.1 Front and rear of Alpha OAE
2.2.2 Top and bottom of AccuScreen
2.3
2.4
2.5
2.5.2 Inserting the battery in Alpha OAE
2.5.4 Charging the battery with the external charger
3
Getting Started with Alpha OAE
3.1
3.1.1 Power-saving mode and automatic power-off
4
4.1
4.2
4.2.1 Preparing the probe for testing
4.3
Preparing the test environment
4.4
4.4.1 Fitting the eartip on the probe
4.4.2 Inserting the probe with eartip in the patient’s ear canal
5
5.1
5.2
5.3
5.4
Options in the test result screens
Otometrics - MADSEN Alpha OAE
17
14
21
9
6
3
4
5.5
Continuing testing on the other ear
5.6
Viewing a patients test record
5.7
5.8
6
6.1
6.2
7
7.1
7.2
7.2.1 Performing the probe test
7.3
7.4
7.5
7.6
7.7
7.8
8
8.1
8.2
8.3
9
9.1
9.1.1 Cleaning and disinfecting the probe tip
9.2
9.3
9.3.1 Cleaning and disinfecting the built-in test cavity
9.4
Battery safety and maintenance
9.4.3 Disposal of old batteries
App. 1
App. 1.3 Docking station symbols
App. 1.4 Warning notes - Alpha OAE
App. 1.6 Repair, after-sales service and regular checks
App. 1.7.1 Responsibility of the manufacturer
App. 2
40
37
45
49
31
29
Otometrics - MADSEN Alpha OAE
App. 2.1 Device related messages
App. 2.2 Usage and test related messages
App. 3
App. 3.2 Measurement techniques
App. 3.4 Power supply and battery
App. 3.8 Notes on EMC (Electromagnetic Compatibility)
51
59
Otometrics - MADSEN Alpha OAE 5
1 Introduction
1
1.1
Introduction
Brief description
Thank you for purchasing the Alpha OAE handheld Otoacoustic Emissions Screener.
Note • This manual is your guide to the use and maintenance of Alpha OAE. We strongly recommend that you read it carefully before using Alpha OAE for the first time.
We also recommend that you take particular note of the cleaning and maintenance instructions.
Failure to use and maintain Alpha OAE correctly may void your warranty.
Alpha OAE is a fast, reliable, easy to use, and lightweight hearing screener.
Alpha OAE provides for easy navigation using its touch screen function.
1.2
1.3
Printing
For printing instructions see
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.
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.
6 Otometrics - MADSEN Alpha OAE
1 Introduction
The device is intended for use by audiologists, ENT's and other healthcare professionals.
Note • There are no known contra-indications for use of Type 1077 device and accessories.
Note • The 1077 device comes in various configurations. The Alpha OAE device, which is a 1077 device, is only available in an OAE configuration.
Important •
Natus Medical Denmark A/S does not guarantee the accuracy of the test results or the tests themselves, if accessor-ies other than those supplied by
Natus Medical Denmark A/S are used for this device (i.e.
eartips).
1.4
1.5
Physical operating principle
Alpha OAE uses DPOAE (Distortion Product Otoacoustic Emissions) technology. Otoacoustic Emissions measure cochlear mechanics and indicate whether the cochlea is functioning correctly or not. Emission strength usually decreases with age or hearing impairment.
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
describes how to unpack Alpha OAE, prepare and connect cables, and set up the device.
Safety
This manual contains information and warnings which must be followed to ensure the safe performance of Alpha OAE.
Local government rules and regulations, if applicable, should also be followed at all times.
Please see the overview of device labeling in
and read the warning notes in
Training
It is recommended that you read this manual before you start operating Alpha OAE so that you become familiar with the device before testing on a client.
To obtain a free printed copy of the user documentation, contact Otometrics (www.otometrics.com).
Maintenance and cleaning
For instructions on how and when to clean Alpha OAE and accessories, please see
Maintenance and Cleaning ► 40 .
Otometrics - MADSEN Alpha OAE 7
1 Introduction
1.6
Typographical conventions
The use of Warning, Caution and Note
To draw your attention to information regarding safe and appropriate use of the device or software, the manual uses 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.
1.6.1
Navigating this manual
Menus, icons and functions to select are shown in bold type, as for instance in:
• Press the
OK
button.
8 Otometrics - MADSEN Alpha OAE
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.
Overview of Alpha OAE
Front and rear of Alpha OAE
A.
On/Off switch
B.
Touch screen display
C.
Power and charging status light indicator
D.
Test cavity
E.
Button for opening battery compartment
F.
Cover on battery compartment with serial number label
Otometrics - MADSEN Alpha OAE 9
2 Unpacking and Installation
2.2.2
Top and bottom of AccuScreen
Top Bottom
A.
Probe socket B.
Connector for label printer
2.2.3
Display
The display is a touch-screen display, where the icons and fields shown serve as buttons.
• Touch the buttons to activate a function.
Caution • Never use any type of sharp instrument on the display. If you do, reliable operation of Alpha OAE can no longer be guaranteed.
2.2.4
Ear probe
Probe cable plug
A.
Probe tip B.
Probe body
C.
Probe cable
10 Otometrics - MADSEN Alpha OAE
2 Unpacking and Installation
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 .
2. Turn on Alpha OAE. See
.
3. Set the date on the device. See
Now you can connect the probe. See
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 Lithium-Ion rechargeable battery
• has a high capacity
• is lightweight
• has a low rate of self discharge
• can be charged continuously
• guarantees approximately 8 hours of operating time
On delivery, the battery is charged approximately 50%. We recommend to charge the battery fully before starting to test.
Use only the battery type, docking station and charger stated in
and
.
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.
Otometrics - MADSEN Alpha OAE 11
2 Unpacking and Installation
2.5.2
Inserting the battery in Alpha OAE
1. Push the button of the battery compartment upwards.
The battery compartment pops out.
2. If needed, remove the battery.
3. Place a new, charged battery in the compartment.
– Hold the battery so that the arrow with the text “Insert this direction” points downwards towards the bottom of the compartment.
4. Close the compartment.
2.5.3
Battery status
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.
Otometrics - MADSEN Alpha OAE
2 Unpacking and Installation
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% The battery is fully charged.
75 - 50%
50 - 25%
25 - 10%
10 - 0%
The battery should be charged.
The battery is very low and testing is not possible.
If the necessary minimum voltage should drop, Alpha OAE switches off automatically. Recharge or change the battery as soon as possible.
Charging the battery with the external charger
Caution • Use only the charger supplied by
Natus Medical Denmark A/S
.
The battery for Alpha OAE is charged by an external charger.
See the charger manufacturer’s documentation for specifications and instructions for use.
Otometrics - MADSEN Alpha OAE 13
3 Getting Started with Alpha OAE
3
3.1
Getting Started with Alpha OAE
In the following, you will find quick instructions for how to use Alpha OAE:
• Switching on Alpha OAE
You will find detailed instructions for preparing and testing in:
•
•
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
–
–
14 Otometrics - MADSEN Alpha OAE
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.
3 Getting Started with Alpha OAE
• See
• See
Viewing a patients test record ► 27
.
Otometrics - MADSEN Alpha OAE 15
3 Getting Started with Alpha OAE
• See
• See
.
• See
• See
16 Otometrics - MADSEN Alpha OAE
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
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
Caution • Insert only disinfected probe tips in the test cavity. See
Cleaning and disinfecting the built-in test cavity ►
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.
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.
Otometrics - MADSEN Alpha OAE 17
4 Preparing for testing
4.3
4.4
When disconnecting the plug, do not twist it. Instead, hold the sleeve of the plug and release it by pulling it straight out of the socket.
The probe will not be released if you pull anywhere else than on the sleeve of the plug.
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.
18 Otometrics - MADSEN Alpha OAE
4 Preparing for testing
4.4.1
Fitting the eartip on the probe
1. Select an eartip that fits the patient's ear canal. You may have to try out a number of sizes in order to select the 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
) and that the probe is connected.
See also
.
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.
Otometrics - MADSEN Alpha OAE 19
4 Preparing for testing
Note • Make sure that the cable is not in contact with any vibrating surfaces during testing.
Warning • In case of ear or ear canal trauma, don’t start any measurements.
20 Otometrics - MADSEN Alpha OAE
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
screen, you can select Child Mode to display a child-friendly screen during testing.
• 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.
Otometrics - MADSEN Alpha OAE 21
5 Testing with Alpha OAE
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.
22
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.
Otometrics - MADSEN Alpha OAE
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 Testing with Alpha OAE
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
.)
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.
• If needed, press the
Stop
button to stop the test. The test will be saved as an incomplete test.
Otometrics - MADSEN Alpha OAE 23
5 Testing with Alpha OAE
5.3.4
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 Pass/Clear Response result or 2 frequencies receive a Refer/No Clear Response 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.
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 ► 26
for a description of the buttons available.
24 Otometrics - MADSEN Alpha OAE
Pass/Clear Response
A single frequency Pass/Clear Response 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 Pass/Clear Response 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 Refer/No Clear Response 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 Pass/Clear Response 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
Refer/No Clear Response with high frequency Pass/Clear Response 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.
5 Testing with Alpha OAE
Otometrics - MADSEN Alpha OAE 25
5 Testing with Alpha OAE
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
Options in the test result screens
Test result options
Print results
See
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.
26 Otometrics - MADSEN Alpha OAE
5 Testing with Alpha OAE
5.5
5.6
5.7
5.8
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 Pass/Clear Response , a Refer/No Clear Response , or an Inconclusive test result.
• If the result is a Pass/Clear Response , no further action is required.
• If the result is a Refer/No Clear Response , it is recommended that you retest the patient. If the patient is given yet another Refer/No Clear Response , 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
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.
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.
Otometrics - MADSEN Alpha OAE 27
5 Testing with Alpha OAE
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 to print.
icon next to the test you wish
For a description of the individual test result types, see
.
28 Otometrics - MADSEN Alpha OAE
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 Alpha OAE when the label printer status light indicates "Cooling down" or "Buffer overflow."
1. Connect the label printer cable to Alpha OAE.
To print individual test results, select
Test View
from the
Home
screen and press the
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
• At the top of the print-out you will find additional fields for entering:
– Last Name
– First Name
Otometrics - MADSEN Alpha OAE 29
6 Printing
– ID
– Date of Birth
– Examiner
Pass/Clear Response Refer/No Clear Response
Legend
P
R
L
R
N
Legend
• Left ear
• Right ear
• Pass
• Refer
• Inconclusive due to Noise
30 Otometrics - MADSEN Alpha OAE
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 Alpha OAE and the
AccuLinkinstalled.
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
).
• From the
Settings
menu (for example, to restart the test or to test the probe using an external test cavity).
Otometrics - MADSEN Alpha OAE 31
7 Alpha OAE settings
7.2.1
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.
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.
32 Otometrics - MADSEN Alpha OAE
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
Delete old tests
check box, then the oldest test will automatically be deleted to make room for the newest test.
If you do not select the
Delete old tests
check box, then a message will be displayed when the memory is full, and you will be required to manually delete old tests. (See
.)
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
Settings
and the time in the lower part of the
Settings
.
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).
7 Alpha OAE settings
Otometrics - MADSEN Alpha OAE 33
7 Alpha OAE settings
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.
34 Otometrics - MADSEN Alpha OAE
7 Alpha OAE settings
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 Pass/Clear Response or Refer/No Clear Response 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
Alpha OAE.
– Darkens the display
– Brightens the display
– Press the Default button to use the default setting for the display brightness.
Otometrics - MADSEN Alpha OAE 35
7 Alpha OAE settings
7.8
System Info
1. Press the ing:
System Info
button on the
Settings
screen to view information regard-
– Firmware release
– HW version and Serial number
– Next Alpha OAE service date
– Connected probe
– Next service date for the connected probe
– Memory usage
36 Otometrics - MADSEN Alpha OAE
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.
8 Handling Data in Alpha OAE
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.
Otometrics - MADSEN Alpha OAE 37
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.
38 Otometrics - MADSEN Alpha OAE
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.
8 Handling Data in Alpha OAE
Otometrics - MADSEN Alpha OAE 39
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
The probe tip
– Remove the probe tip from the probe.
40 Otometrics - MADSEN Alpha OAE
9 Maintenance and Cleaning
– 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.
Otometrics - MADSEN Alpha OAE 41
9 Maintenance and Cleaning
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.
42 Otometrics - MADSEN Alpha OAE
9 Maintenance and Cleaning
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.
Otometrics - MADSEN Alpha OAE 43
9 Maintenance and Cleaning
9.4.2
9.4.3
Increasing service life
• Use only the battery type and charger stated in
.
• 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 replace the 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 rechargeable 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.
44 Otometrics - MADSEN Alpha OAE
App. 1 Standards and Safety
App. 1 Standards and Safety
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
Symbol Definition
Non sterile product.
Do not reuse.
Otometrics - MADSEN Alpha OAE 45
App. 1 Standards and Safety
App. 1.3
Docking station symbols
Symbol Definition
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 or ear coupler 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 and due to effects on EMC, accessories connected to the equipment's outlet fittings must be identical to the type supplied with the system.
46 Otometrics - MADSEN Alpha OAE
App. 1 Standards and Safety
• Disposable accessories, such as eartips, should not be reused and must be replaced between patients to prevent crossinfection.
• We recommend that the device should not be stacked with other equipment or placed in a poorly ventilated space as this may affect the performance of the device. If it is stacked or placed adjacent to other equipment, make sure that the operation of the device is not affected.
• 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.
Otometrics - MADSEN Alpha OAE 47
App. 1 Standards and Safety
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
Natus Medical Denmark 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.
48 Otometrics - MADSEN Alpha OAE
App. 2 Status and Error Messages
App. 2 Status and Error Messages
App. 2.1
Device related messages
Error message Cause
• The battery charge is low.
or
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
Solution
• Recharge Alpha OAE or replace the battery with a spare.
• The real time clock power backup has been completely drained.
• Set the time and date: Select
Settings > Date and Time
.
• Contact your supplier.
• Self test error.
• Self test error.
• Self test error: Invalid test data has been found in flash memory.
• Self test error.
• Contact your supplier.
• Contact your supplier.
• 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
Stimulus high
• Testing environment is too noisy.
• The probe has a poor fit in the ear canal.
• The probe is not in the ear canal.
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.).
• Try to refit the probe.
Otometrics - MADSEN Alpha OAE 49
App. 2 Status and Error Messages
Error message
Stimulus low
Paper feed error
Cause
• 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. 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.
50 Otometrics - MADSEN Alpha OAE
App. 3 Technical Specifications
App. 3 Technical Specifications
App. 3.1
Accessories
Standard accessories and optional accessories may vary from country to country - please consult your local distributor.
Standard accessories
Starter kit (includes ear tips, probe tips, and probe tip cleaning tool)
OAE probe (Cable Approx. length: 150 cm/59 inches)
External battery charger
User Manual
Battery
Cleaning cloth
Transportation bag
Optional accessories
Ear tips
Probe tips
Probe tip cleaning tool
Label printer with printer cable
Probe (Approx. length: 150 cm/59 inches)
Docking station, including power adapter
Standard accessories and optional accessories may vary from country to country - please consult your local distributor.
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 ( Pass/Clear Response at 3 out of 4)
L1/L2 = 65/55 dB SPL
DP-Gram, DPOAE level, noise level
Overall Pass/Clear Response or Refer/No Clear Response , DP-Gram with
DPOAE and noise level.
6 - 8 dB
- 5 dB
App. 3.3
Device
MADSEN Alpha OAE is type 1077 from Natus Medical Denmark A/S .
Dimensions
Approx.
200 x 73 x 34 mm (7.9 x 2.9 x 1.3 inches)
Otometrics - MADSEN Alpha OAE 51
App. 3 Technical Specifications
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 Pass/Clear Response and Refer/No Clear Response 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
52 Otometrics - MADSEN Alpha OAE
App. 3 Technical Specifications
Operating environment
Mode of operation:
Temperature range:
Humidity range:
Air pressure
Continuous
10 - 40°C (50 - 104°F)
30 - 90 % rel., non-condensing
500 hPa* to 1060 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.
Essential performance
MADSEN Alpha OAE has no essential performance and accordingly, the applicable requirements are as stated in the following:
• Otoacoustic emissions as defined by EN 60645-6, Type 2
• Basic safety as defined by IEC 60601-1
All information required by IEC 60601-1-2:2007, #5.2.2.1-#5.2.2.10 is available in the MADSEN Alpha OAE User Manual.
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 60601-2-40
EN 60601-1-2
App. 3.4
Power supply and battery
Device
Supply voltage:
Maximum battery power consumption:
Nom. 3.70 V,
Max. 4.20 V,
Min. 3.20 V (measured with device load)
1.5 W while measuring
Otometrics - MADSEN Alpha OAE 53
App. 3 Technical Specifications
Estimated battery life:
Battery level indicator:
Battery
8 hours of continuous use (based on a typical use scenario. Actual use can influence the battery life time.)
5-step battery level indicator
Caution • Use only rechargeable battery supplied by
Natus Medical Denmark 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:
Max. power consumption when Alpha
OAE is docked:
Max. power consumption when Alpha
OAE is not docked:
Power adapter
Input voltage/range:
Output voltage:
Output current:
Mains plug types:
5 V DC ±5%
5 VA (5 V, 1.0 A)
0.25 VA (5 V, 50 mA)
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/59 inches
54 Otometrics - MADSEN Alpha OAE
App. 3 Technical Specifications
Dimensions
Probe body:
Probe tip:
Weight
Probe incl. probe tip:
Eartips
Silicone tree 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
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)
Otometrics - MADSEN Alpha OAE 55
App. 3 Technical Specifications
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.
Guidance and 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 is used in such an environment.
Emissions test 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 emissions are 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.
Guidance and manufacturer's declaration - electromagnetic immunity 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 is used in such an environment.
Immunity test IEC 60601 test level
Compliance level Electromagnetic environment - guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
+/- 6 kV contact
+/- 8 kV air
+/- 6 kV contact
+/- 8 kV air
Floors should be wood, 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
3 A/m 3 A/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.
56 Otometrics - MADSEN Alpha OAE
App. 3 Technical Specifications
Guidance and manufacturer's declaration - electromagnetic immunity - for equipment and systems that are NOT life-supporting
MADSEN Alpha OAE is intended for use in the electromagnetic environment specified below. The user of MADSEN Alpha OAE should ensure that it is used in such an environment.
Immunity test IEC 60601 test level
Compliance level Electromagnetic environment - guidance
Radiated RF
IEC 61000-4-3
150 kHz to 80 MHz outside ISM bands a
3 V/m
80 MHz to 2.5 GHz
3 V/m
Portable and 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 80 MHz to 800 MHz d = 2.3
for 80 MHz 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 strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less 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 strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio 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 be considered. 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 is observed, additional measures might be necessary, such as reorienting or relocating MADSEN Alpha OAE.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Otometrics - MADSEN Alpha OAE 57
App. 3 Technical Specifications
Recommended separation distances between portable and mobile RF communications equipment and MADSEN Alpha OAE
The MADSEN Alpha OAE is 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 a minimum 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 MHz to 800 MHz d = 1.2
800 MHz to 2.5 GHz d = 2.3
0.01
0.1
1
0.12
0.38
1.2
0.12
0.38
1.2
0.23
0.73
2.3
10
100
3.8
12
3.8
12
7.3
23
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 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.
58 Otometrics - MADSEN Alpha OAE
Index
Index
A
Accessory symbols
After-sales service
Alpha OAE printing starting
switch on
Assembling the device
Automatic power off
B
Battery
changing disposal
extending life maintenance
operating time recharging
status
status symbols
storage
type
Brightness, display
Buttons function bar buttons general
C
Changing battery
Cleaning
device
probe tip test cavity
Connecting probe to Alpha OAE
D
Data deleting data
Delete a test
Delete all tests
Device bottom view
Otometrics - MADSEN Alpha OAE cleaning front view
preparing for testing
rear view
technical specifications
top view
Display
error messages
Display brightness
Disposal device
DPOAE
eartips
old battery
test
test procedure test results
E
Ear probe view
Eartips
disposal
fitting on probe maintenance
Environment
preparing test
Equipment preparation
Error message
device related
usage and test related
F
Function buttons
G
General buttons
I
Inserting probe in ear
L
Labelprinter
Language settings
59
Index
60
M
Maintenance battery
cleaning device
cleaning test cavity disposal of batteries
eartips
increasing battery life
probe
probe body
probe calibration probe tip
Manufacturer
Messages on display
P
Patient preparing
Pinna
Power
power off automatic saving mode
Powering Alpha OAE
Preparing device for testing
fitting eartip on probe for testing
patient
Preparing equipment
Printing
from Alpha OAE types of printout
Probe body cable
cleaning tip
connecting to Alpha OAE fitting eartip
maintenance
prepare for testing tip
view
Probe body maintenance
Probe calibration maintenance
Probe tip
cleaning
maintenance
R
Recharging battery
Remove
battery test
Repair
Results test view
S
Safety information
Safety symbols
Screens
Home menu
Service life
,
increasing
Settings
brightness
from the Settings menu
language
performing probe test
probe test
sound
system info
the Settings menu time and date
Sharp instruments, using on display
Sound setting
Starting Alpha OAE
Status messages
Storing Alpha OAE
Switching on Alpha OAE
System info
T
Technical specifications
Test
DPOAE procedure
Otometrics - MADSEN Alpha OAE
Index options in screens prepare probe for ready to
test view
Test cavity cleaning
Test environment
Test result
DPOAE
Test View
screen
Testing preparing for
Time and date settings
U
Unpacking
V
Views device top display
ear probe front
rear
W
Warning notes
Warranty repair
Otometrics - MADSEN Alpha OAE 61
advertisement
Related manuals
advertisement