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Summary of Contents for natus MADSEN Alpha OAE+
- Page 1 MADSEN® Alpha OAE+ Screener User Manual Doc. No. 7-50-1360-US/07 Part No. 7-50-13600-US...
- Page 2 Rx only Copyright notice © 2014, 2018, 2021 Natus Medical Denmark ApS. All rights reserved. ® Otometrics, the Otometrics Icon, AURICAL, MADSEN, Otoscan, ICS and HORTMANN are registered trademarks of Natus Medical Denmark ApS in the U.S.A. and/or other countries.
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Page 3: Table Of Contents
MADSEN Alpha OAE+ Screener User Manual Table of Contents Introduction ................................5 1.1 Brief description ......................5 1.2 Docking station ......................5 1.3 Printing ......................... 5 1.4 Intended Use ......................... 5 1.5 Physical operating principle ................... 6 1.6 About this manual ......................6 1.7 Typographical conventions .................... - Page 4 MADSEN Alpha OAE+ Screener User Manual 10 Maintenance and Cleaning ............................45 10.1 Probe tip / Probe body ..................45 10.2 Eartips ......................... 47 10.3 Cleaning Alpha OAE+ ................... 47 10.4 Battery safety and maintenance ................48 Appendix 1. Standards and Safety ........................49 Appendix 1.1 Warranty ....................
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Page 5: Introduction
Note: The 1077 device comes in various configurations. The Alpha OAE+ device, which is a 1077 device, is only available in an OAE configuration. Note: Natus Medical Denmark ApS does not guarantee the accuracy of the test results or the tests themselves, if accessories other than those supplied by Natus Medical Denmark ApS are used for this device (e.g., eartips). -
Page 6: Physical Operating Principle
You should read this manual before you start operating Alpha OAE+ to become familiar with the device before testing on a client. Note: To obtain a free printed copy of the user documentation, contact Natus Medical Denmark ApS ( natus.com). -
Page 7: Warnings - Alpha Oae
MADSEN Alpha OAE+ Screener User Manual 1.9 Warnings – 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. •... - Page 8 MADSEN Alpha OAE+ Screener User Manual 1.9.3 Glossary of Symbols Symbol Standard Reference Standard Title Symbol Title Explanation 93/42/EEC EU Medical Device Regulation CE marking Signifies European technical conformity. Medical Device Directive (Notified body XXXX number appears under symbol.) 21 CFR Labeling-Prescription devices Prescription only Indicates that the...
- Page 9 MADSEN Alpha OAE+ Screener User Manual Symbol Standard Reference Standard Title Symbol Title Explanation ISO 15223-1 Indicates the Medical devices — Symbols to be used Catalogue number manufacturer’s with medical device labels, labelling and catalogue number Symbol 5.1.6 information to be supplied so that the medical device can be identified.
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Page 10: Unpacking And Installation
MADSEN Alpha OAE+ Screener User Manual 2 Unpacking and Installation 2.1 Unpacking Unpack the device carefully. When you unpack the device and accessories, you should keep the packing material. If you need to send the device in for service, the original packing material will protect against damage during transport, etc. - Page 11 MADSEN Alpha OAE+ Screener User Manual 2.2.1 Docking station Front Indicators POWER. Lit when power is supplied to the docking station. Lit when data is being transferred: during transfer of a report to the PC during printing from label printer USB.
- Page 12 MADSEN Alpha OAE+ Screener User Manual 2.2.2 Display The touchscreen display has icons and fields. Note: Never use any type of sharp instrument on the display. If you do, reliable operation of Alpha OAE+ can no longer be guaranteed. 2.2.3 Ear probe A.
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Page 13: Storage
MADSEN Alpha OAE+ Screener User Manual 2.3 Storage Store Alpha OAE+ and accessories in the soft case provided to protect the equipment from damage. See also Operating environment in Technical Specifications. 2.4 Assembly before When you receive Alpha OAE+, perform the following steps you connect the probe. - Page 14 MADSEN Alpha OAE+ Screener User Manual 2.5.2 Inserting the battery in Alpha OAE+ 1. Push the button of the battery compartment upwards. The battery compartment opens. 2. Remove the discharged battery. 3. Place a new, charged battery in the compartment. –...
- Page 15 MADSEN Alpha OAE+ Screener User Manual 2.5.3 Battery status • The battery symbol is shown in the top right corner of the display, enabling you to view the status of the battery at all times. • When less than 25% of the battery capacity remains, you should change the battery and recharge it as soon as possible. •...
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Page 16: Madsen Alpha Oae+ Printing Tool Install
2.5.2 Charge battery with external charger Caution: Use only the charger supplied by Natus Medical Denmark ApS. The battery for Alpha OAE+ is charged by an external charger (optional accessory). Note: See the charger manufacturer documentation for specifications and instructions for use. -
Page 17: Getting Started With Alpha Oae
MADSEN Alpha OAE+ Screener User Manual 3 Getting Started with Alpha OAE+ You can find instructions on switching on Alpha OAE+. You can also find detailed instructions for preparing and testing in Preparing for testing, Testing with Alpha OAE+, 23. 3.1 Switch on On/Off Switch on Alpha OAE+: Press the... -
Page 18: Alpha Oae+ Patient Information
MADSEN Alpha OAE+ Screener User Manual 3.1.3 Home menu Home menu shows the Alpha OAE+ functions. Quick Start. See TEOAE test, Find Patient. See View a patient test record, New Patient. See View a patient test record, Print. See Printing, Delete. - Page 19 MADSEN Alpha OAE+ Screener User Manual Searching in an extended patient list Find Patient ( Find Patient To search in an extended list of patients, press in the screen. The default search criteria is the patient's last name. If you wish to change the search criteria, press Search Criteria ( Enter the patient’s data (for example, last name or record number) according to the search criteria you have chosen.
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Page 20: Preparing For Testing
MADSEN Alpha OAE+ Screener User Manual 4 Preparing for testing 4.1 Preparing Alpha OAE+ • Follow the instructions in Getting Started with Alpha OAE+, • See Testing with Alpha OAE+, 23 on how to proceed with the specific tests. 4.2 Preparing the equipment Every day before you start testing on patients, you should test the probe to make sure that it functions correctly. -
Page 21: Preparing The Patient
MADSEN Alpha OAE+ Screener User Manual 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. •... - Page 22 MADSEN Alpha OAE+ Screener User Manual 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.
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Page 23: Testing With Alpha Oae
MADSEN Alpha OAE+ Screener User Manual 5 Testing with Alpha OAE+ Before you begin to test: • Decide on which ear you wish to perform the test. • Prepare as described in Preparing for testing, 5.1 Selecting Child Mode Press Child Mode ( ) to display a child-friendly screen during testing. -
Page 24: Dpoae Test
MADSEN Alpha OAE+ Screener User Manual Select or create a patient – and then start a test Find ( ) or add ( ) a new patient. (see Finding a patient, 18 Add new patient, 18). Press OK ( ). The patient Test Menu appears. Note: There are 7 DPOAE protocols and 1 TEOAE protocol. - Page 25 MADSEN Alpha OAE+ Screener User Manual Protocol 5 and 6 6 kHz 5 kHz 4 kHz 3 kHz 2 kHz 1.5 kHz Minimum DP amplitude equals -5 dB. Protocol 5: a Pass/Clear Response result requires that 4 of the 6 frequencies receive a Pass/Clear Response result. The test stops automatically if 4 frequencies reach a Pass/Clear Response result or 3 frequencies receive a Refer/No Clear Response result.
- Page 26 MADSEN Alpha OAE+ Screener User Manual 5.3.2 Starting the test Press Start ( next to the test protocol and ear you want to test. Calibration and speaker tests are performed. Calibration. If the probe does not fit correctly, adjust the position of the probe. Speaker Test.
- Page 27 MADSEN Alpha OAE+ Screener User Manual 5.3.3 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. Child Mode When is activated, an animated car appears during testing. (See Selecting Child Mode, 23.) The progress bar under the animated car is green if the test conditions are good.
- Page 28 MADSEN Alpha OAE+ Screener User Manual 5.3.4 DPOAE test results In Child Mode, when a test is completed, the Reward screen is displayed, regardless of the test result (screen shows balloons). The test Test result outcome is displayed. If Child Mode is not activated, the screen is displayed immediately after the test is complete.
- Page 29 MADSEN Alpha OAE+ Screener User Manual Inconclusive test If it is not possible to achieve a Pass result and: • the patient has a large ear canal volume and the test was started with the Manual Start ( ) after a failed calibration, -or- •...
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Page 30: Teoae Test
MADSEN Alpha OAE+ Screener User Manual 5.4 TEOAE test 5.4.1 TEOAE test protocol Protocol 8 measures non-linear TEOAE. The frequency range for the test signal is approximately 1 kHz to 4 kHz. A Pass/Clear Response result requires detection of 8 peaks in the range 6 ms to 12 ms of the response. Start ( Protocol 8 To start the test, press... - Page 31 MADSEN Alpha OAE+ Screener User Manual 5.4.2 TEOAE test Selecting Child Mode If Child Mode is activated, an animated car is displayed on the screen during testing. (See 23.) 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.
- Page 32 MADSEN Alpha OAE+ Screener User Manual 5.4.3 TEOAE test results Child Mode When a test is completed, the Reward screen is displayed regardless of the test result. The outcome of the test is displayed on the Test result screen. If Child Mode is not activated, the Test result screen is displayed after the test is completed. Press OK ( ) to return to the Test Menu.
- Page 33 MADSEN Alpha OAE+ Screener User Manual If there is large ear canal volume (due to PE tubes or perforation of the eardrum) it may not be possible for the L1/L2 to reach the required stimulus levels. Adequate stimulus levels are crucial to achieve an accurate response. The result is Inconclusive, and a message indicates that there was a large ear canal volume or a poor probe fit.
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Page 34: Test Result Options
MADSEN Alpha OAE+ Screener User Manual 5.5 Test result options Test result options To add comments to the test results, press Comments ( ). The Comments screen appears. Select a predefined comment. See Test Comments, Test Other Ear Starts test in the other ear. Start Start ( To repeat the test, press... -
Page 35: Continue Testing On Other Ear
MADSEN Alpha OAE+ Screener User Manual 5.7 Continue testing on other ear Before you continue testing the other ear, make sure that the probe is clean. See also Maintenance and Cleaning, If needed, reposition the patient so that you can test the other ear and insert the probe in the new test ear. Press Test Other Ear ( ) in the test results screen. -
Page 36: Test View Screen
MADSEN Alpha OAE+ Screener User Manual 5.11 Test View screen The Test View screen displays the tests that have been made on a particular patient. The tests are listed according to date, with the most recent tests at the top of the list. To view more tests press scroll up or down in the list. -
Page 37: Printing
MADSEN Alpha OAE+ Screener User Manual 7 Printing Depending on your configuration, you can print complete results from Alpha OAE+ using a docking station connected to a PC with a printer, or using a label printer connected to the docking station. 7.1 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. -
Page 38: Label Printouts
MADSEN Alpha OAE+ Screener User Manual 7.2 Label printouts The printouts show the following: patient first / last name, Patient ID, Date of testing, Test type, Left and/or right ear result (date and time), comments. Best results The most recent and best results for the selected patient are printed for all test types. One label per test is printed. Selected tests A label is printed for each of the selected tests. -
Page 39: Alpha Oae+ Settings
MADSEN Alpha OAE+ Screener User Manual 8 Alpha OAE+ settings You can configure your Alpha OAE+ from the Alpha OAE+ Settings menu. 8.1 Settings menu Settings From ), you can change Alpha OAE+ settings. 8.2 Probe Test You should test the probe daily to ensure that it functions correctly. You must test the probe before patient testing. Note: Make sure that the probe tip has been cleaned and disinfected before you insert it in the test cavity. -
Page 40: Test Settings
MADSEN Alpha OAE+ Screener User Manual 8.2.1 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. Probe OK Probe failed If the probe functions correctly, the... -
Page 41: Time And Date Setting
MADSEN Alpha OAE+ Screener User Manual Delete old tests. To determine what occurs after 500 tests (or 250 patients) have been stored and the Alpha OAE+ memory is full. Press Delete old tests and the oldest test will be deleted to free up room for the newest test. Delete old tests If you do not select a message appears when the memory is full. -
Page 42: System Info
MADSEN Alpha OAE+ Screener User Manual 8.7 System Info Press System Info to view information regarding: – Firmware release – HW version and Serial number – Next Alpha OAE+ Service date – Connected probe – Next Probe Service date for the connected probe –... -
Page 43: Handling Data In Alpha Oae
MADSEN Alpha OAE+ Screener User Manual 9 Handling Data in Alpha OAE+ 9.1 Function buttons To enter or edit data, select the characters and digits from the keypad. Tap Shift ( ) to type uppercase letters. Double-press Shift ( ) to turn Caps Lock on. Press abc ( ) or çêü... -
Page 44: Deleting Data
MADSEN Alpha OAE+ Screener User Manual 9.2 Deleting data Delete Press Delete ( ) to delete: Single test or All tests. Single test. Press Delete ( ) next to the test. Confirm deletion. All tests. Confirm that you want to delete all tests. 9.2.1 Delete one test To delete one single test, press Delete (... -
Page 45: Maintenance And Cleaning
MADSEN Alpha OAE+ Screener User Manual 10 Maintenance and Cleaning 10.1 Probe tip / Probe body Follow established infection control procedures for the setting in which you are working. Never place the probe tip in the ear canal without using a clean eartip. Note: The probe tip usually does not contact the skin or secretion from the ear canal, as it is covered by the eartip. - Page 46 10.1.3 Probe calibration Note: Natus Medical Denmark ApS recommends that an annual calibration be performed on Alpha OAE+ and probe. Natus Medical Denmark ApS also recommends that calibration be performed if the equipment has suffered any potential damage. The Alpha OAE+ probe is calibrated at the factory. There may not be a full year to the next calibration date stated on the calibration certificate.
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Page 47: Eartips
MADSEN Alpha OAE+ Screener User Manual 10.2 Eartips Eartips are disposable and should not be cleaned. Note: Eartips and the Alpha OAE+ Screener should be disposed of according to local regulations. 10.3 Cleaning Alpha OAE+ Before cleaning, switch off Alpha OAE+ and unplug it from any external power source. ... -
Page 48: Battery Safety And Maintenance
Keep the battery's terminals clean. Clean with a soft cloth if necessary. Battery renewal Caution: The battery capacity will gradually degrade by many charging/discharging cycles and by ageing. Natus Medical Denmark ApS recommends that you replace the battery approximately every 12 to 18 months. -
Page 49: Appendix 1. Standards And Safety
Appendix 1. Standards and Safety Appendix 1.1 Warranty For product warranty information, please see natus.com. Appendix 1.2 Repair, after-sales service and regular checks If Alpha OAE+ 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. -
Page 50: Appendix 2. Status And Error Messages
MADSEN Alpha OAE+ Screener User Manual Appendix 2. Status and Error Messages Appendix 2.1 Device related messages Error message Cause Solution Recharge Alpha OAE+ or replace the battery with a spare. • The battery charge is low. Low battery voltage Settings >... -
Page 51: Appendix 3. Technical Specifications
MADSEN Alpha OAE+ Screener User Manual Appendix 3. Technical Specifications Appendix 3.1 Accessories Standard accessories and optional accessories may vary from country to country – consult your local distributor. Standard accessories Carrying case Docking station, including power adapter and USB cable ... -
Page 52: Appendix 3.3 Device
MADSEN Alpha OAE+ Screener User Manual Appendix 3.3 Device MADSEN Alpha OAE+ is type 1077 from Natus Medical Denmark ApS. 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... -
Page 53: Appendix 3.4 Power Supply And Battery
Equipment) Directive 2012/19/EU. These regulations state that electrical and electronic waste must be separately collected for the proper treatment and recovery to ensure that WEEE is reused or recycled safely. In line with that commitment Natus Medical Incorporated may pass along the obligation for take back and recycling to the end user, unless other arrangements have been made. Please contact us for details on the collection and recovery systems available to you in your region at natus.com. -
Page 54: Appendix 3.5 1077 Docking Station
Charge time in Alpha OAE+ docking station: 80% charged: 4½ hours Battery Warning: Use only the rechargeable battery supplied by Natus Medical Denmark ApS, 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... -
Page 55: Appendix 3.7 Notes On Emc (Electromagnetic Compatibility)
MADSEN Alpha OAE+ Screener User Manual Appendix 3.7 Notes on EMC (Electromagnetic Compatibility) MADSEN Alpha OAE+ is part of a medical electrical system and is subject to special safety precautions. 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 MADSEN Alpha OAE+ functions. - Page 56 MADSEN Alpha OAE+ Screener User Manual Power frequency 30 A/m No relevant ports that could be Power frequency magnetic fields should be at levels (50/60 Hz) magnetic field affected characteristic of a typical location in a typical IEC 61000-4-8 commercial or hospital environment. is the AC mains voltage prior to application of the test level.
- Page 57 MADSEN Alpha OAE+ Screener User Manual 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.
- Page 58 MADSEN Alpha OAE+ Screener User Manual 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 59 MADSEN Alpha OAE+ Screener User Manual 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 OAE+ as recommended below, according to the maximum output power of the communications equipment.
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