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MADSEN Alpha OAE+ Screener User Manual

1.9.3

Glossary of Symbols

Symbol

Standard Reference

Standard Title

Symbol Title

Explanation

XXXX

93/42/EEC

U Medical Device Regulation

Medical Device Directive

E marking

ignifies European

technical conformity.
(Notified body
number appears
under symbol.)

Rx only

21 CFR
801.109(b)(1)

Labeling-Prescription devices

Prescription only

Indicates that the
product is authorized
for sale by or on the
order of a licensed
healthcare
practitioner.

UL Listing

N/A

Nationally
Recognized

Testing Laboratories

(NRTL) certifications

IEC 60417

Table D.1 #20

Medical electrical equipment

– Part 1:

General requirements for basic safety
and Essential performance

Type BF applied
part

Identifies a type BF
applied part
complying with IEC
60601-1.

ISO 15223-1, Symbol
5.4.3

Medical devices

– Symbols to be used

with medical device labels, labelling,
and information to be supplied

Consult
Instructions for
Use

Indicates the need
for the user to
consult the
instructions for use.

IEC 60601-1,
Table D.2 #10

Medical electrical equipment

– Part 1:

General requirements for basic safety
and essential performance

Follow Instructions
for Use

Refer to instruction
manual/Booklet.

NOTE on ME
EQUIPMENT

“Follow Instructions
for use”.

2012/19/EU

Waste Electrical and Electronic
Equipment (WEEE)

Disposal at the end
of operating life
instructions

Indicates that
electrical and
electronic equipment
waste should not be
discarded together
with unseparated
waste but must be
collected separately.

ISO 15223-1

Symbol 5.2.8

Medical devices

– Symbols to be used

with medical device labels, labelling,
and information to be supplied

Do not use if
package
is damaged

Indicates that the
medical device
should not be used if
the package has
been damaged or
opened.

ISO 15223-1, Clause
5.2.7

Medical devices

— Symbols to be used

with medical device labels, labelling and
information to be supplied

Non sterile

Indicates that the
medical device that
has not been
subjected to a
sterilization process.

ISO 15223-1

Symbol 5.4.2

Medical devices

– Symbols to be used

with medical device labels, labelling,
and information to be supplied

Do not re-use

Indicates that the
medical device is
intended for one
use, or for use on a
single patient during
a single procedure.

IEC 60601-1,
Table D.1 #4

Medical electrical equipment

— Part 1:

General requirements for basic safety
and Essential performance

Direct current

Indicates on the
rating plate that the
equipment is
suitable for direct
current only; to
identify relevant
terminals.

Not applicable

An indication of
Medical Device

This product is a
medical device.

Содержание MADSEN Alpha OAE+

Страница 1: ...MADSEN Alpha OAE Screener User Manual Doc No 7 50 1360 US 07 Part No 7 50 13600 US ...

Страница 2: ...com Rx only Copyrightnotice 2014 2018 2021 Natus MedicalDenmarkApS Allrights reserved Otometrics the Otometrics Icon AURICAL MADSEN Otoscan ICSand HORTMANN are registered trademarks of Natus MedicalDenmarkApSin the U S A and orothercountries Version release date 11 05 2021 204006 Technicalsupport Please contact yoursupplier ...

Страница 3: ...0 4 1Preparing Alpha OAE 20 4 2Preparing the equipment 20 4 3Preparing the test environment 20 4 4Preparing the patient 21 5 Testing with Alpha OAE 23 5 1Selecting Child Mode 23 5 2Ready to test 23 5 3DPOAE test 24 5 4TEOAE test 30 5 5Test result options 34 5 6Test Comments 34 5 7Continue testing on other ear 35 5 8Handling test results 35 5 9View a patient test record 35 5 10 Test View 35 5 11 Te...

Страница 4: ...rvice and regular checks 49 Appendix 1 3 Declaration 49 Appendix 1 4 Responsibility of the manufacturer 49 Appendix 2 Status and Error Messages 50 Appendix 2 1 Device related messages 50 Appendix 3 Technical Specifications 51 Appendix 3 1 Accessories 51 Appendix 3 2 Measurement techniques 51 Appendix 3 3 Device 52 Appendix 3 4 Power supply and battery 53 Appendix 3 5 1077 docking station 54 Append...

Страница 5: ... 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 dis orders 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 ad...

Страница 6: ...ocumentation contact Natus Medical Denmark ApS natus com Maintenance and cleaning For instructions on how and when to clean Alpha OAE and accessories please see Maintenance and Cleaning 45 1 7 Typographical conventions Warnings Cautions and Notes To draw your attention to information regarding safe and appropriate use of the device or software the manual uses precautionary statements as follows Wa...

Страница 7: ...not within patient reach 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 Use only the power supplies specified in Technical Specifications Power adapter Alpha OAE must not be us...

Страница 8: ...ME EQUIPMENT Follow Instructions for use 2012 19 EU Waste Electrical and Electronic Equipment WEEE Disposal at the end of operating life instructions Indicates that electrical and electronic equipment waste should not be discarded together with unseparated waste but must be collected separately ISO 15223 1 Symbol 5 2 8 Medical devices Symbols to be used with medical device labels labelling and inf...

Страница 9: ... Humidity limitation Indicates the range of storage humidity to which the medical device can be safely exposed ISO 15223 1 Symbol 5 3 9 Medical devices Symbols to be used with medical device labels labelling and information to be supplied Atmospheric pressure limitation Indicates the acceptable upper and lower limits of atmospheric pressure for transport and storage ISO 15223 1 Symbol 5 3 7 Medica...

Страница 10: ...ble damage If damage has occurred do not operate the device Contact your local distributor for assistance Check the packing list to ensure you have received all necessary parts and accessories If your package is incomplete contact your local distributor 2 2 Alpha OAE Overview 2 2 1 Front and rear A On Off switch D Test cavity B Touchscreen E Button for opening battery compartment C Power and charg...

Страница 11: ...docking station Lit when data is being transferred during transfer of a report to the PC during printing from label printer USB Lit when docking station is connected to the PC through a USB cable Rear Sockets PC USB Socket for USB connection to the PC Printer Modem Socket for printer modem connection Power Adapter Socket ...

Страница 12: ...splay 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 Probe tip B Probe body C Probe cable Probe cable plug ...

Страница 13: ...e Charge battery with external charger 16 2 5 1 Alpha OAE 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 No...

Страница 14: ...button of the battery compartment upwards The battery compartment opens 2 Remove the discharged 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 toward the compartment bottom 4 Close the compartment ...

Страница 15: ... station The Alpha OAE docking station is powered through an adapter from the mains outlet To comply with the safety requirements for a medical device system connection to the docking station must always be done outside the patient area min 1 5 meters 5 feet from the patient You will find an adapter plug kit when you unpack Alpha OAE The adapter plug kit contains a range of adapter plugs you can c...

Страница 16: ...tation 2 If the installation wizard does not start automatically then browse to d Alpha OAE where d denotes the location disk drive or USB port of the installation media and double click MADSEN OAE Printing Tool version number exe 3 Configure the printing tool using the installation wizard Configure Save PDF file If you select this option the file dialog will be shown each time you create a report...

Страница 17: ...matic power off If you do not use Alpha OAE for a certain time Alpha OAE will switch to power saving mode and then switch off automatically When Alpha OAE is in power saving mode the display displays black and the power indicator illuminates green Touch the screen to reactivate Alpha OAE 3 1 2 Alpha OAE screens Buttons are described in Function buttons 43 Navigating the screens in Alpha OAE The sc...

Страница 18: ... mode See Selecting Child Mode 23 3 2 Alpha OAE patient information 3 2 1 Add new patient 1 Press New Patient The New Patient screen appears 2 Enter patient data and then press OK 3 Press down arrow to view more new patient fields 4 Press OK The data is saved and the Test Menu appears 3 2 2 Finding a patient 1 To find a patient press Find Patient on the Home screen The Find Patient screen appears ...

Страница 19: ...ample last name or record number according to the search criteria you have chosen 4 Press OK to start the search 5 The search will produce a list of patients matching the search criteria 6 Select a patient The Patient Details screen appears 7 Press Test View to view the patient tests performed 3 2 3 Editing patient data 1 Find a patient as described in Finding a patient 18 2 In the Patient Details...

Страница 20: ...onnected to this socket Place Alpha OAE face down Align the ridge on the probe plug with the notch in the grey bordered socket on the top end of Alpha OAE Gently insert the probe plug into the probe socket The plug does not require force to be inserted properly Disconnecting the probe Note Do not pull the plug by the cable when you disconnect the probe Instead pull the sleeve of the grey connector...

Страница 21: ... 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 specified by the disinfectant manufacturer to ensure its effectiveness Always use new eartips 4 4 Preparing the patient Preparing the patient 1 Position the patient so that you can easily access the ear to be tested 2 Grasp the pinna and gently ...

Страница 22: ...Caution Using a probe with an unsuitably sized eartip or applying excessive force may irritate the ear canal Note In case of a probe error make sure that the probe tip channels are clear see Maintenance and Cleaning 45 and that the probe is connected See also ProbeTest 39 4 4 2 Inserting the probe with eartip in the patient s ear canal When you have fitted an eartip on the probe grasp the pinna an...

Страница 23: ... An animated car is displayed on the screen during testinginstead of the data 5 2 Ready to test You can choose between two methods of starting a test 1 Start a test without selecting a patient 2 Select or create a patient and then start a test Start a test without selecting a patient 1 Press Quick Start The Test Menu screen 2 See the test descriptions in TEOAE test 30 and DPOAE test 24 After the t...

Страница 24: ...is L2 5 3 1 DPOAE test protocols The L1 L2 pair is 65 55 dB SPL Only F2 is shown The test is conducted by measuring the frequencies in decreasing order the results are displayed with the frequencies increasing from left to right Protocol 1 and Protocol 2 6 kHz 5 kHz 4 kHz 3 5 kHz 3 kHz 2 5 kHz Minimum DP amplitude equals 5 dB A Pass Clear Response result requires that 4 of the 6 frequencies receiv...

Страница 25: ...esponse result or 3 frequencies receive a Refer No Clear Response result Protocol 6 no overall Pass Clear Response or Refer No Clear Response result is generated All frequencies are tested Protocol 7 5 kHz 4 kHz 3 kHz 2 kHz Minimum DP amplitude equals 10 dB Protocol 7 a Pass Clear Response result requires that 3 of the 4 frequencies receive a Pass Clear Response result The test stops automatically...

Страница 26: ... both speakers function correctly The test starts automatically when calibration is completed Note If an Incomplete message appears Adjust the position of the probe Press Start to restart the test Note 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...

Страница 27: ...a bar chart is displayed See the Test details table below for a description of the bar chart Press Stop to stop the test The test will be saved as an incomplete test 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 r...

Страница 28: ...aring loss cannot be detected by DPOAE testing Refer No Clear Response In Protocols 1 2 and 5 a Refer No Clear Response result indicates that in at least 3 frequency bands out of 6 no significant DPOAE response could be detected In Protocols 3 4 and 7 a Refer No Clear Response result indicates that in at least 2 frequency bands out of 4 no significant DPOAE response could be detected Protocol 6 do...

Страница 29: ...imulus 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 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 is stopped an error message appears The result screen...

Страница 30: ...the test press Start next to Protocol 8 and that corresponds to the ear in which you placed the probe Calibration occurs before the actual test starts The test starts automatically when calibration is completed 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 appea...

Страница 31: ...counted both above and below the median line in order to lead to a Pass Clear Response 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 A high Noise level may indicate a high level of environmental noise or a noisy patient Artifact Shows the average artifact level in percent The artifact rate emanating from noi...

Страница 32: ...have a sensorineural hearing loss Always consider the factors below however when you interpret a Refer No Clear Response result It may be possible to improve the quality of the test and so on repeating the test a Pass Clear Response may be obtained It is always recommended that you repeat the test when a Refer No Clear Response result is obtained Consider for instance the following when you interp...

Страница 33: ... accurate response 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 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 and detailed results are shown The result screen is different if t...

Страница 34: ...es to show the result The buttons show the best most recent test Press the specific button to view the result 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 Test Completed 5 6 Test Comments 1 To add a standard comment press t...

Страница 35: ... report with a PC that has the MADSEN Alpha OAE printing tool installed or with a label printer See Printing from Alpha OAE 37 5 9 View a patient test record A patient is given a Pass Clear Response a Refer No Clear Response or an Inconclusive test result Pass Clear Response No further action is required Refer No Clear Response Retest the patient If the patient is given yet another Refer No Clear ...

Страница 36: ...test results 32 If you want to view test result comments press Comments 6 Quick Start Tests You can press the Quick Start button to start a test without selecting a patient beforehand You can print or save the results after performing the test or just delete the test 6 1 Quick Start Perform the steps in Preparing for testing 20 However do not add a new patient or assign the test to a specific pati...

Страница 37: ...e 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 Note The Alpha OAE docking station should not be connected simultaneously to both a PC and the ...

Страница 38: ... 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 Pass Clear Response Refer No Clear Response Legend L Left ear R Right ear P Pass R Refer N Inconclusive due to Noise ...

Страница 39: ...o 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 See Cleaning the built in test cavity 47 You can start the probe test in two ways Inserting the probe in the Alpha OAE test cavity see Performing the probe test 40 or Go to Settings to restart the test or to t...

Страница 40: ... see a list of possible errors 2 Press OK to confirm the test result If needed repeat the test 8 2 2 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 Settings Probe Test For more information see Performing the probe test 40 8 3 Test Settings Press Test Settings to select the test protocols to include in the Test You...

Страница 41: ... to PE tubes in the child s ears then a double arrow appears on the result screen Press double arrow to start the measurement with maximum calibrated output levels 8 4 Time and Date setting Press Settings Time and Date There are multiple date formats Note If you leave the Time and Date screen by pressing OK the seconds setting is set to zero Time You can set a 24 hour clock or 12 hour am pm 8 5 La...

Страница 42: ...ser Manual 42 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 Memory usage ...

Страница 43: ...xt mandatory field Patient Search Enter the patient s name Press OK to search Press sort to change the sort order Press up down to see the patients in a list Press test view to view the patient s test list General Buttons Use the main function buttons to return to a previous screen view help go home confirm an action or toggle search criteria Press return to return to the previous screen Press hel...

Страница 44: ...s Confirm that you want to delete all tests 9 2 1 Delete one test 1 To delete one single test press Delete The Delete menu appears 2 Press Single test 3 In the Delete screen select the patient whose test you want to delete This action takes you to the Test View screen to select one or more tests to delete 4 Press Delete You are prompted to confirm that you want to delete this test ...

Страница 45: ...obe tip Caution If needed replace the probe tip with a spare one Note Probe tips and the Alpha OAE Screener should be disposed of according to local regulations 10 1 1 Cleaning and disinfecting the probe tip Remove the ear probe from the patient s ear and separate the probe tip from the disposable eartip before cleaning Note You should always comply with local hygienic standards See Hygienic Preca...

Страница 46: ...be body mechanically or with liquids Doing so may cause damage to the probe Warning 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 No part of the ear probe should be subjected to ultrasonic cleaning solutions or machines 10 1 3 Probe calibration Note Na...

Страница 47: ...araldehyde 2 5 Ortho phthalaldehyde a k a OPA 0 5 2 Chlorhexidingluconat 2 4 Warning You should ensure that moisture does not enter the probe the sockets data interface connector and probe plugs or the test cavity Warning Never immerse Alpha OAE into water or other cleaning solutions Note Use of cleaning agents other than those recommended in the user manual can cause damage to the device for exam...

Страница 48: ... type and charger stated in Appendix 3 4 Power supply and battery 53 Charge the battery at room temperature whenever possible Do not drop the battery or expose it to sharp impact Store in a cool dry place Keep the battery s terminals clean Clean with a soft cloth if necessary Battery renewal Caution The battery capacity will gradually degrade by many charging discharging cycles and by ageing Natus...

Страница 49: ...ectronics engineer should verify the safety of all equipment Calibration should be performed annually by suitably qualified personnel using the appropriate equipment Appendix 1 3 Declaration All devices of the type Alpha OAE should be checked and calibrated annually through a service center authorized by the manufacturer Appendix 1 4 Responsibility of the manufacturer Caution All assembly operatio...

Страница 50: ...be FAILED 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 Make sure that the probe tip is clean andthat 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 theprobe is damaged Speaker mis...

Страница 51: ... level 75 dB A 5 dB in 2 cc coupler self calibration depending on ear canal volume Click rate 65 80 clicks per second randomized Input filter 1 to 4 kHz Test display Averaged waveform no of TEOAE peaks noise level artifact level stability level and test progress Result display Averaged waveform no of TEOAE peaks and overall Pass Clear Response or Refer No Clear Response On Refer No Clear Response ...

Страница 52: ...e stamping The clock is automatically synchronized with PC clock when docked Accuracy Max deviation 12 minutes year Backup Min 7 days when battery is removed from unit Data interfaces PC IR data transmission to docking station USB interface from docking station to PC Label printer IR data transmission to docking station RS232 interface from docking station to label printer Modem IR data transmissi...

Страница 53: ...se the municipal collection schemes or the producer importers take back obligation or licensed waste carriers to reduce adverse environmental impacts in connection with disposal of waste electrical and electronic equipment and to increase opportunities for reuse recycling and recovery of waste electrical and electronic equipment Equipment marked with the below crossed out wheeled bin is electrical...

Страница 54: ...rom the USB interface Printer modem interface Interface type RS232 Connector type 6 pol Mini Din DC power input Input voltage 5 V DC 5 Max power consumption when Alpha OAE is docked 5 VA 5 V 1 0 A Max power consumption when Alpha OAE is not docked 0 25 VA 5 V 50 mA Power adapter Input voltage range 100 240 V AC 50 60 Hz Output voltage 5 0 V DC Output current Minimum 1 0 A Mains plug types US UK Eu...

Страница 55: ...t applicable Guidanceand manufacturer sdeclaration 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 insuch an environment Immunity test IEC 60601 test level Compliancelevel Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000...

Страница 56: ...F wireless communicationequipment must be more than 30cm 11 8inches Note These guidelines may not apply in all situations Electromagnetic propagation isaffected by absorption and reflection from structures objects and people 28V m 810MHz 870MHz 930MHz 28V m 810MHz 870MHz 930MHz 28V m 1720MHz 1845MHz 1970MHz 28V m 1720MHz 1845MHz 1970MHz 28V m 2450MHz 28V m 2450MHz 9V m 5240MHz 5500MHz 5785MHz 9V m...

Страница 57: ... 4 5 1kV line s to line s 2kV line s to earth 1kV line s to line s 2kV line s to earth Mainspower quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply inputlinesIEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 s 5 UT 95 dip...

Страница 58: ... an electromagnetic site survey a should be lessthan the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with thissymbol Radiated RF IEC 61000 4 3 3V m 80MHzto 2 5GHz 3V m 80MHzto 2 5GHz Note 1 At 80MHzand 800MHzthe separation distancefor thehigher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic p...

Страница 59: ...m output power of transmitter W Separation distance according to frequency of transmitter m 150kHzto 80MHz d 1 2 80MHzto 800MHz d 1 2 800MHzto 2 5GHz d 2 3 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 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 ...

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