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Summary of Contents for otometrics MADSEN Alpha OAE
- Page 1 MADSEN Alpha OAE Screener User Manual Doc. No. 7-50-1370-US/05 Part No. 7-50-13700-US...
- Page 2 Copyright notice © 2014, 2018 Natus Medical Denmark A/S. All rights reserved. ® Otometrics, the Otometrics Icon, AURICAL, MADSEN, ICS and HORTMANN are registered trademarks of Natus Medical Denmark A/S in the U.S.A. and/or other countries. Version release date 04-24-2018 (183899) Technical support Please contact your supplier.
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Page 3: Table Of Contents
Testing with Alpha OAE Selecting Child Mode Ready to test 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 Options in the test result screens Otometrics - MADSEN Alpha OAE... - Page 4 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 Otometrics - MADSEN Alpha OAE...
- Page 5 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 Otometrics - MADSEN Alpha OAE...
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Page 6: Introduction
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. Otometrics - MADSEN Alpha OAE... -
Page 7: Physical Operating Principle
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... -
Page 8: Typographical Conventions
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 button. Otometrics - MADSEN Alpha OAE... -
Page 9: Unpacking And Installation
Front and rear of Alpha OAE A. On/Off switch D. Test cavity B. Touch screen display Button for opening battery compartment C. Power and charging status light indicator Cover on battery compartment with serial number label Otometrics - MADSEN Alpha OAE... -
Page 10: Top And Bottom Of Accuscreen
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 Otometrics - MADSEN Alpha OAE... -
Page 11: Storage
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... -
Page 12: Inserting The Battery In Alpha Oae
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... -
Page 13: Charging The Battery With The External Charger
Charging the battery with the external charger Use only the charger supplied by Natus Medical Denmark A/S. Caution • 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... -
Page 14: Getting Started With Alpha Oae
When Alpha OAE is in power-saving mode, the display goes black and the power indicator lights up green. • Simply touch the screen to reactivate Alpha OAE. 3.1.2 The Alpha OAE screens • Buttons are described in – Function buttons ► – General buttons ► Otometrics - MADSEN Alpha OAE... -
Page 15: The Home Menu
3.1.3 The Home menu The Home menu Home From the menu, you can select all main functions in Alpha OAE. • The DPOAE test ► • Viewing a patients test record ► Otometrics - MADSEN Alpha OAE... - Page 16 3 Getting Started with Alpha OAE ► • Printing ► • Deleting data • Alpha OAE settings ► • Selecting Child Mode ► Otometrics - MADSEN Alpha OAE...
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Page 17: Preparing For Testing
3. Gently insert the probe plug into the probe socket. The plug does not require force to be inserted properly. Disconnecting the probe Caution • Do not pull the plug by the cable when you disconnect the probe. Instead, pull the sleeve of the grey con- nector. Otometrics - MADSEN Alpha OAE... -
Page 18: Preparing The Test Environment
2. Grasp the pinna and gently pull back and slightly away from the patient's head. 3. Look into the ear canal. 4. Inspect the ear canal to make sure it is clear of cerumen or debris as this may affect the res- ult of the test. Otometrics - MADSEN Alpha OAE... -
Page 19: Fitting The Eartip On The Probe
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... - Page 20 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. • Otometrics - MADSEN Alpha OAE...
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Page 21: Testing With Alpha Oae
Ready to test Home Test • On the screen, press the button corresponding to the ear you wish to test. Otometrics - MADSEN Alpha OAE... -
Page 22: The Dpoae Test
The test starts automatically when calibration is completed. “Incomplete” message Incomplete If the message appears: • Refit the probe and make sure that it fits correctly. Start • Press the button to restart the test. Otometrics - MADSEN Alpha OAE... -
Page 23: The Dpoae Test
See the table below for a description of the bar chart and other data displayed. Stop • If needed, press the button to stop the test. The test will be saved as an incomplete test. Otometrics - MADSEN Alpha OAE... -
Page 24: Dpoae Test Results
The outcome of the test is then displayed on the Test result screen.If Test result Child Mode is not activated, the screen is displayed immediately after the test is completed. Options in the test result screens ► for a description of the buttons available. Otometrics - MADSEN Alpha OAE... - Page 25 Refer/No Clear Response Pass/Clear Response with high frequency is a strong indic- ator that test conditions were not optimal. If this is the case, it is recommended that you improve test conditions and repeat the test. Otometrics - MADSEN Alpha OAE...
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Page 26: Options In The Test Result Screens
Test result options Print results ► Printing Test Other Ear Starts test in the other ear. Start Start If you wish to repeat the test, press the button. Press to return to the Home screen. Otometrics - MADSEN Alpha OAE... -
Page 27: Continuing Testing On The Other Ear
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... - Page 28 Print 3. To print the individual test results, press the icon next to the test you wish to print. For a description of the individual test result types, see DPOAE test results ► Otometrics - MADSEN Alpha OAE...
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Page 29: Printing
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... - Page 30 6 Printing – – Date of Birth – Examiner Pass/Clear Response Refer/No Clear Response Legend Legend • Left ear • Right ear • Pass • Refer • Inconclusive due to Noise Otometrics - MADSEN Alpha OAE...
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Page 31: Alpha Oae Settings
Simply by inserting the probe in the test cavity of Alpha OAE (see Performing the probe test 32). Settings • From the menu (for example, to restart the test or to test the probe using an external test cavity). Otometrics - MADSEN Alpha OAE... -
Page 32: Performing The Probe Test
Probe failed If the probe does not function correctly, the message appears. You will also see a list of possible errors. 2. Press the button to confirm the test result. If needed, repeat the test. Otometrics - MADSEN Alpha OAE... -
Page 33: From The Settings Menu
If you leave the screen by pressing the button, the set- ting of seconds is set to zero. 2. Press the arrows to select the day (DD), month (MM), year (YYYY), hours (HH) and minutes (MIN). Otometrics - MADSEN Alpha OAE... -
Page 34: Language Setting
2. To change the language on Alpha OAE, press the button with the preferred lan- guage. Note • Your screen showing the available languages may not appear as the one shown. Otometrics - MADSEN Alpha OAE... -
Page 35: Sound Setting
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... -
Page 36: System Info
– Firmware release – HW version and Serial number – Next Alpha OAE service date – Connected probe – Next service date for the connected probe – Memory usage Otometrics - MADSEN Alpha OAE... -
Page 37: Handling Data In Alpha Oae
To perform these functions, simply press the relevant function button. Function buttons • Scroll to see more/next page 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... -
Page 38: Deleting Data
4. When you have deleted all the tests you wish to delete, press the Home button to go to the Home screen. 8.3.2 Deleting all tests Delete Home 1. To delete all tests, press the button on the screen. Otometrics - MADSEN Alpha OAE... - Page 39 8 Handling Data in Alpha OAE Delete This will take you directly to the menu. All tests 2. Press the button. You will be prompted to confirm that you wish to delete all tests. All tests will be deleted. Otometrics - MADSEN Alpha OAE...
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Page 40: Maintenance And Cleaning
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. • Hygienic precautions ► The probe tip – Remove the probe tip from the probe. Otometrics - MADSEN Alpha OAE... -
Page 41: Cleaning The Probe Body
– 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... -
Page 42: Probe Calibration
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. Otometrics - MADSEN Alpha OAE... -
Page 43: Cleaning And Disinfecting The Built-In Test Cavity
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... -
Page 44: Increasing Service Life
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. Otometrics - MADSEN Alpha OAE... -
Page 45: App. 1 Standards And Safety
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 con- tact your local authorities for advice on disposal. -
Page 46: App. 1.3 Docking Station Symbols
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 con- tact your local authorities for advice on disposal. -
Page 47: App. 1.5 Warranty
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... -
Page 48: App. 1.6.1 Declaration
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. Otometrics - MADSEN Alpha OAE... -
Page 49: App. 2 Status And Error Messages
Reduce noise (talking, mobile phones, noisy. etc.). Stimulus high • The probe has a poor fit in the • Try to refit the probe. ear canal. • The probe is not in the ear canal. Otometrics - MADSEN Alpha OAE... - Page 50 The probe tip is blocked. Paper feed error • The labels are not adjusted cor- • Re-adjust the labels and remove possible rectly in the label printer or blocking of paper feed. there is a paper jam. Otometrics - MADSEN Alpha OAE...
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Page 51: App. 3 Technical Specifications
6 - 8 dB Minimum Amplitude: - 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... - Page 52 Data interfaces Label printer: RS232 interface to Label Printer Transport and storage environment Temperature range: -20 - +60°C (-4 - 140°F) Humidity range: 10 - 90 % rel., non-condensing Air pressure 500 hPa to 1040 hPa Otometrics - MADSEN Alpha OAE...
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Page 53: App. 3.4 Power Supply And Battery
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 fol- lowing: •... -
Page 54: App. 3.5 1077 Docking Station
100-240 V AC, 50-60 Hz Output voltage: 5.0 V DC Output current: Minimum 1.0 A Mains plug types: US, UK, Europe and Australia App. 3.6 OAE probe Probe cable Flexible, shielded cable. Approx. length: 150 cm/59 inches Otometrics - MADSEN Alpha OAE... -
Page 55: App. 3.7 Device Class
7 - 11 mm, Orange 11 - 15 mm, Red Foam tip: 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... -
Page 56: App. 3.8 Notes On Emc (Electromagnetic Compatibility)
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. - Page 57 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.
- Page 58 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.
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Page 59: Index
Cleaning device Function buttons probe tip test cavity Connecting probe to Alpha OAE General buttons Data Inserting probe in ear deleting data Delete a test Delete all tests Labelprinter Device Language settings bottom view Otometrics - MADSEN Alpha OAE... - Page 60 Starting Alpha OAE cleaning tip Status messages connecting to Alpha OAE Storing Alpha OAE fitting eartip Switching on Alpha OAE maintenance System info prepare for testing Technical specifications view Test Probe body DPOAE procedure maintenance Otometrics - MADSEN Alpha OAE...
- Page 61 Test cavity cleaning Test environment Test result DPOAE Test View screen Testing preparing for Time and date settings Unpacking Views device top display ear probe front rear Warning notes Warranty repair Otometrics - MADSEN Alpha OAE...
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