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Resonance r14o User Handbook Manual

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Summary of Contents for Resonance r14o

  • Page 1 OAE Screener QUICK USER’S HANDBOOK...

  • Page 2: Release History

    Release history November 2017 First issue February 20237 added DPOAE Screener M.R.S. s.r.l. is the manufacturer of the R14O OAE Screener. www.resonance-audiology.com...
  • Page 3 Index ENGLISH...
  • Page 4 this page is intentionally left blank...

  • Page 5: Table Of Contents

    ENGLISH Table of contents 1- Introduction and intended use 2 - Description 2.1 Precautions 2.2 Warranty and maintenance 2.3 Unpacking and checking the r14o 2.4 Accessories 2.5 Connecting the accessories 2.6 Power Sources 2.7 Installation 2.8 Battery indicator 2.9 Symbols present on device 3 - Components and connectors 3.1 Power on and off the device...

  • Page 6: Description

    Carefully store this manual away in a safe place for each future consultation. The r14o OAE Screener is designed and manufactured to meet or exceed all quality and safety requi- rements, and has been certified with CE-symbol according to European Medical Devices Directive. All the functions are software-controlled, upgrading the software at a later date will be simple and free of charge.

  • Page 7: Precautions

    Any possible modification and/or alteration to this device is prohibited, without prior authorization thereto by the Manufacturer. If the r14o is connected to other devices with their own power source, the system conforms to IEC 60601-1 must be checked under the responsibility of the installer; in the event that isolation devices are used to achieve such conformity, these must comply with IEC 60601-1.

  • Page 8: Warranty And Maintenance

    Warranty and maintenance RESONANCE warrants that: The r14o is free from defects in material and workmanship under normal use and service for a period of • 24 months from the date of device’s installation by authorized personnel to the first purchaser.

  • Page 9: Unpacking And Checking The R14O

    Should the device be dropped or fall, it may sustain hidden damage that may result in hazardous operation. In case of any doubt, please do not use the device and either contact your Resonance Dealer, or e-mail the Resonance Customer Support Service directly at support@resonance-audiology.com Keep all original packaging for future use.
  • Page 10 Accessories Image Description Standard / Optional Plug OAE Probe* ● PROBE (3) OAE Test cavity ● Kit Tips OAE ● Medical CE approved power supply: Model: MENB1010A0503(xyz) (xyz) = B01 changeable direct plug-in 5 VDC (xyz) = Q01 with power cord ●...
  • Page 11 USB pen drive for PC use ● Carrying bag ● Wi-Fi thermal printer ○ External USB Keyboard ○ = standard = optional * = applied part ● ○ The applied parts are represented by the transducers and pushbutton which are placed in contact with the patient.

  • Page 12: Connecting The Accessories

    Connecting the accessories Please connect all the cables before powering on the device. Reference Symbol Function 5 VDC Socket for external power supply USB Host port for connection of pen drive (for software update) or external keyboard (optional) Probe Socket for Probe: OAE probe USB Slave connector: used for wired data transfer 5 - 6 n.a.

  • Page 13: Power Sources

    Power Sources The device can operate with its own internal rechargeable battery (Li-ion 3.6 V / 3 Ah), or connected to the medical power supply, or placed on the charging cradle. The average recharge time of an empty battery is less than 4 hours, both with direct feeder link or with its charging cradle.

  • Page 14: Symbols Present On Device

    Symbols present on device 5 VDC - Direct current (Medical CE approved power supply) Refer to instruction Refer to manual for transducer and power supply connection Class II device. (Symbol refers to external medical power supply with double insulation) BF type applied parts Electric and electronic waste may contain hazardous substances and therefore has to be collected separately Together with name and address indicates the manufacturer of the instrument...

  • Page 15: Power On And Off The Device

    Description Socket for Probe 2 - 3 Not used 7” TFT Resistive touch screen display Main switch Led: shows that battery is charging Socket for medical power supply USB Slave connector: used for wired data transfer USB Host port for connection of pen drive (for software update) or external keyboard (optional) 3.1 Power on and off the device To turn on the device, press briefly the Main switch (5) and wait for the appearance of the boot screen...

  • Page 16: Pin Code Request

    3.2 PIN Code request When switching the device on a PIN code is requested to access both the device functionalities and the data it contains. The default PIN code set by the manufacturer is 1234. After the PIN code has been typed in the starting screen is presented.

  • Page 17: Teoae Screening

    4.1 TEOAE Screening The Otoacoustic Emissions Test allows evaluating outer hair cell functionality. The test is performed using a small probe which is inserted into the external ear canal, stimulating the cochlea by a wideband signal and measuring the response signal produced by the outer cells. The automatic screening result is based on the signal to noise ratio of the otoacoustic emissions.
  • Page 18 When the test is finalized, the results are shown on the screen: PASS: test passed, valid OAE response detected. REFER: test failed, no OAE response detected. NOT COMPLETED: test stopped by the operator. Press SETUP (see picture beside) to open the test setup page. The screening setup page is protected with a PIN code.

  • Page 19: Teoae Diagnostic

    Artefact Level In this field the maximum acceptable noise level can be selected. When the noise exceeds the set value, the measurement is rejected (artefact). By touching this field a value between 20 and 60 dB SPL can be selected or can be switched off. SNR dB By clicking the SNR labels, the signal to noise ratios are set for the individual frequencies.
  • Page 20 The main screen displays three graphs: on the left side a histogram showing the signal/noise ratio for all frequencies, on the upper right the A and B buffers and on the lower right the signal and noise frequency response. Press the left graph to switch ear side. Press START to start the test.
  • Page 21 The menu allows for the setting of a few test parameters: Adjustable parameters: Max Stimuli Max test time. By touching this field the maximum test time, between 30 and 75 seconds, can be selected. When a valid result is obtained the test is automatically stopped. Artefact Level In this field the maximum acceptable noise level can be selected.

  • Page 22: Dpoae

    4.3 DPOAE Screening The DPOAE (Distortion Product Otoacoustic Emissions) test is performed by simultaneously presenting two tonal stimuli to which a normal cochlear function responds is the generation of other tonal responses. The size of these responses is plotted in a graph as function of one of the stimulus frequencies and is called a DP-gram.
  • Page 23 When the test is finalized, the results are shown on the screen: PASS: test passed, valid OAE response detected. REFER: test failed, no OAE response detected. NOT COMPLETED: test stopped by the operator. Press SETUP (see picture beside) to open the test setup page. The screening setup page is protected with a PIN code.
  • Page 24 Adjustable parameters: Timeout Maximum search time per single frequency. By touching this field the maximum waiting time, between 2 and 16 seconds, can be selected. When selecting “Auto” the test proceeds to the next frequency on reaching the pass criterion for the current frequency. Stimulus Level F1 This field allows to select the pure tone signal intensity for F1.
  • Page 25 4.4 DPOAE Diagnostic The DPOAE (Distortion Product Otoacoustic Emissions) test is performed by simultaneously presenting two tonal stimuli to which a normal cochlear function responds is the generation of other tonal responses. The size of these responses is plotted in a graph as function of one of the stimulus frequencies and is called a DP-gram.
  • Page 26 PASS: test passed; the measurement met the set criteria. Detection criteria can be customized in the setup menu, based on the specific screening or diagnostic needs. REFER: test failed, no OAE response detected. The measurement did not meet the set criteria. NOT COMPLETED: test stopped by the operator.
  • Page 27 Adjustable parameters: Timeout Maximum search time per single frequency. By touching this field the maximum waiting time, between 2 and 16 seconds, can be selected. When selecting “Auto” the test proceeds to the next frequency on reaching the pass criterion for the current frequency. Stimulus Level F1 This field allows to select the pure tone signal intensity for F1.

  • Page 28: General Setup

    After switching on the device, set the parameters that affect the test operation. Press the SETUP icon (see adjacent image) to enter the setup page, there the settings are grouped as follow: GENERAL; OAE. 5.1 General Setup Press one of the tabs to access the respective Setup page:...
  • Page 29 Bluetooth Press the BLUETOOTH icon (see adjacent image) to activate database data transmission to PC, if set to OFF transmission is disabled. Autosave Press the AUTOSAVE icon (see adjacent image) to enable the autosave mode. If enabled, once selected a patient, every performed test will be automatically stored into the data- base after pressing the EXIT icon;...
  • Page 30 Report header customization You can customize the report header you print by importing a graphic file that contains your logo or information about your company. The graphic file must be in BMP format, black and white (1 bit x pixel) and have a maximum size of 600x400 pixels. Create a folder named Printer Logo in the root of the pen drive, copy the file or files to be used inside and insert it in the USB HOST port of the device.
  • Page 31 The DELETE button will allow you to delete the selected file. If the printer is connected, using this key it is possible to print the test page with its logo.
  • Page 32 Licenses Press the LICENSES icon (see adjacent image) to check the active test licenses. The following is displayed: To add a new license, press the ADD NEW button and enter the license code:...
  • Page 33 The ADD NEW button should be pressed again to confirm the device recognizes the validity of the license and will display a confirmation message stating the test that has been added An error is displayed if the license is not valid. If there are no active licenses, the tests can be used in demonstration mode up to 10 times.
  • Page 34 Date and time Press the DATE icon (see adjacent image) to set date and time. Use the arrows to adjust the date and time. Press this icon to confirm. Security Opens the security page. Allows setting the GDPR pin code which is used at startup of the instrument Allows setting the Screening pin code which is used to grant access to the setup in Screening TEOAE and Screening DPOAE.
  • Page 35 Patient Mandatory Fields Allows setting what fields of the patient database are obligatory. The Mother’s name is specific for newborn screening programs and can be disabled / hidden. About Pressing the ABOUT icon displays the devices’ serial number, firmware, and software versions.
  • Page 36 5.2 OAE Setup Press the OAE tab to enter the respective setup page: End of test criterion after obtaining the PASS With this key (see adjacent image) it is possible to establish the criterion for ending the test in case of Pass: it is possible to end the test just when the Pass is obtained or, even if the pass was obtained, continue to the end of time and see overall result.

  • Page 37: Oae Calibration

    If the malfunction persists, contact technical support. Extension of the maximum ear volume limit The device automatically adjusts the levels of stimuli adapting to the volume of the ear, the maximum limit is about 2.8ml. In some cases, it may be necessary to perform the test even if a higher volume is detected (e.g., perforated eardrum).
  • Page 38 The device has an internal memory which can store patient data and test results. The data- base is accessed by pressing the PATIENT button on the home screen. In the database, all data stored can be displayed. Database The left column lists patients, the center column shows test sessions associated to the patient, and the right-hand column displays demographics.
  • Page 39 “Session report” MDS function. If you wish to print directly from the unit, switch the printer on and insert the WiFi dongle in the R14O USB port. Please note that the two devices require 20-30 seconds to connect.
  • Page 40 Data transfer from the device to PC is possible via Bluetooth connection. To transfer test results stored within the R14O and subsequently view, edit, print or store them in a NOAH database, the PC suite Resonance MDS must be installed on to a computer. The installation file named MRS Resonance Setup.exe is supplied on the USB pen-drive which includes this operating manual.
  • Page 41 Device labels TOP HOUSING BOTTOM HOUSING...
  • Page 42 Save the test in the database? Save current settings in setup? Is it possible to perform the print out. The button is active only if the printer is active and connected to the Wi-Fi adapter. Update also the calibration date? Calibration expired.
  • Page 43 Attention, optional test license is not Optional test license is correct. correct. Attention, battery is running low. Connect The noise level is too high for the test to be the device to its medical power supply to performed. Check the probe correct positioning and/or the selected noise level in recharge and continue the test.
  • Page 44 The connected probe is not suitable for No probe is connected. Connect a probe. the selected test. The probe needs to be replaced with the correct one. The connected probe is coupled to another The probe is not properly inserted into the device.
  • Page 46 Calibration and any possible repair, installation and/or update of the device must be strictly carried out only by specialized technical personnel, duly authorized by the r14o manufacturer and in full compliance with the terms and conditions specified in the Technical Manual.

  • Page 47: Otoacoustic Emission Probe Maintenance

    Otoacoustic emission probe maintenance 11.1 Before using the probe, make sure it is clean and its transparent plastic tip is totally free from ear wax residues to prevent blockages. To clean the probe proceed as follows: 1. Slightly but firmly hold the probe and turn the upper part to align the two black dots.
  • Page 48 5. Make sure the 3 channels are comple- tely free from any kind of debris. Eventually change the probe tip with a new one. 6. Place the transparent probe tip back making sure the recess on the tip is properly matched with the correspon- ding tooth on the front part of the probe.

  • Page 49: Electrical Safety

    As a manufacturer, we recommend to perform an annual inspection and calibration in order to ensure safety and quality of the measurement. Annual calibration and maintenance should only be carried out by RESONANCE authorized personnel. M.R.S. will not be liable for any failure to comply with the specified inspection date, according to the...
  • Page 50 Model r14o-TE r14o-DP r14o-TE/DP Code 4300103010 4300103030 4300103015 4300103040 4300103050 Test TEOAE Screener ● ● ○ ○ ● TEOAE Advanced screener ○ ● ○ ○ ● DPOAE Screener ○ ○ ● ● ● DPOAE Advanced screener ○ ○ ○ ●...
  • Page 51 Otoacoustic Emissions Number of probes: Acquisition 24 bit 44.1Ksps TEOAE Stimulus level: 70 ÷ 90 dB peSPL Stimulus frequency: 66 Hz Stimulus type: non-linear click Measurement interval: 512 samples, 5 to 15 msec. Bandwidth: from 750 Hz to 5 KHz Artefact noise level: from 20 to 60 dB SPL or off Protocols:...
  • Page 52 Dimensions W x D x H: 180 x 135 x 41 mm Weight: 572 g net Environmental conditions Transport and storage: Temperature: from -20 to +50 °C Humidity: from 20 to 90% without condensation Pressure: from 500 hPa to 1060 hPa Operation: Temperature: from +15 °C to +35 °C Humidity: from 20 to 90% without condensation Pressure: from 700 hPa to 1060 hPa...
  • Page 53 Guidance and manufacturer’s declaration – Electromagnetic emissions The R14O is suitable for use in the specified electromagnetic environment. The purchaser or user of the R14O should assure that it is used in an electromagnetic environment as described below: Emissions test...
  • Page 54 70 % Un for 25 cycles Test level interruptions, it is recommended supply input lines 0 % Un for 5 s that the R14O be powered from IEC 61000-4-11 an uninterruptible power supply or a battery. Power frequency magnetic fields...
  • Page 55 this page is intentionally left blank...

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