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Interacoustics OtoRead Instructions For Use Manual

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Instructions for Use ─ US
OtoRead™
D-0116685-A – 2017/02

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Summary of Contents for Interacoustics OtoRead

  • Page 1 Instructions for Use ─ US OtoRead™ D-0116685-A – 2017/02...

  • Page 3: Table Of Contents

    Battery lifetime and charging time ............15 2.6.2.3 Indication lights on OtoRead ..............15 2.6.2.4 Connecting the Micro-Probe to the OtoRead ........15 OPERATING INSTRUCTIONS ......................17 Battery charge status indicator ................18 General ........................19 Attaching ear tips ....................19 Removing ear tips ....................
  • Page 4 Viewing results ......................24 Viewing DPOAE results with normative data............24 Rounding results ..................... 25 General ........................26 Saving results ......................26 Deleting results ....................... 26 Printing to a thermal printer ..................27 Connection to the PC module ................. 28 Menu Structure .......................
  • Page 5 APPENDICES..........................55...

  • Page 7: Introduction

    OtoRead™ Instructions for Use - US Page 1 1 Introduction About this manual This manual is valid for the OtoRead™ (valid from version 3.20). This product is manufactured by: Interacoustics A/S Audiometer Allé 1 5500 Middlefart Denmark Tel.: +45 6371 3555...
  • Page 8 The level of these emissions can be compared with the level of the noise. The SPL and frequencies of the test tones and the averaging time used to process the signals can be determined by the tester through adjustable settings maintained in static memory within the OtoRead instrument.
  • Page 9 OtoRead™ Instructions for Use - US Page 3 The system consists of the following included and optional parts: Included Components Item Number 8504335 OtoRead device 8504337 Micro-Probe 8029254 Micro-USB Power Supply for Charging the Lithium-Ion Battery 8101864 Micro B to A USB Cable for PC Communication/Charging...
  • Page 10 OtoRead™ Instructions for Use - US Page 4...

  • Page 11: Unpacking And Installation

    Return Report, which can be found in the shipping box, will be of great help to us and is your best guarantee that the correction of the problem will be to your satisfaction. Storage If you need to store the OtoRead™ for a period, please ensure it is stored under the conditions specified in the section for technical specifications.
  • Page 12 Failing to do so may endanger the environment. The CE-mark indicates that Interacoustics A/S meets the requirements of Annex II of the Medical Device Directive 93/42/EEC. TÜV Product Service, Identification No. 0123, has approved the quality system.
  • Page 13 CAUTION If the system is not functioning properly, do not operate it until all necessary repairs have been completed and the unit has been tested and calibrated for proper functioning in accordance with Interacoustics published specifications. Do not drop or otherwise cause undue impact to this device. If the instrument is dropped or otherwise damaged, return it to the manufacturer for repair and/or calibration.

  • Page 14: Environmental Factors

    Connect only accessories purchased from Interacoustics to the OtoRead . Only accessories which have been stated by Interacoustics to be compatible are allowed to be connected to the device or cradle. WARNING This equipment is intended to be connected to other equipment thus forming a Medical Electrical System.

  • Page 15: Electrical And Electrostatic Safety

    OtoRead™ Instructions for Use - US Page 9 Electrical and electrostatic safety Before performing any service to the insert earphones you must detach CAUTION the OtoRead transducers from the patient. Electromagnetic compatibility (EMC) Although the instrument fulfills the relevant EMC requirements, precautions CAUTION should be taken to avoid unnecessary exposure to electromagnetic fields, e.g.,...

  • Page 16: Use Of Equipment After Transport And Storage

    OtoRead™ Instructions for Use - US Page 10 Use of equipment after transport and storage Please make sure the instrument is functioning correctly before use by running a test on a normal hearing subject. If the instrument has been stored in a colder environment (even for a short period of time) please allow the instrument to become acclimatized.
  • Page 17 U-shaped placement guides. Proper placement in the cradle is needed to ensure charging of the battery. Grasp the upper portion of the OtoRead above the cradle placement guides and lift it out of the cradle.

  • Page 18: Battery Charging

    OtoRead™ Instructions for Use - US Page 12 Installing the Sanibel MPT-II printer (optional) The OtoReadTM communicates with the MPT-II using a wireless connection protocol. Use only the recommended label printer from provided with the equipment. Battery charging The label printer is powered by a Lithium-ion battery. Connect the power charger to the outlet on the left hand side of the printer.

  • Page 19: Using The Printer

    OtoRead™ Instructions for Use - US Page 13 Using the printer Printer self-test: While printer is powered OFF, press and hold PAPER FEED button, then press and hold POWER BUTTON simultaneously. When beep is heard after approx. 3 seconds, release both buttons, and a test page will print with information on current status and character samples.

  • Page 20: Charging And Powering The Otoread Tm

    OtoRead™ Instructions for Use - US Page 14 The probe houses a microphone and two speaker tubes which produce test stimuli and measure the sound pressure level (SPL) present in the sealed ear canal. Interface of the instrument to the ear canal is accomplished through disposable ear tips made of industrial elastomer which fit onto the probe tip.

  • Page 21: Battery Lifetime And Charging Time

    OtoRead . The plug will fit in only one orientation. An Interacoustics logo is on the probe connector and will align with the instrument control panel. Misalignment of the plug and socket can cause damage. The plug and socket should be visually inspected prior to each installation of the remote probe.
  • Page 22 HDMI connector that allows the calibration data to be stored within the cable/plug (also known as an ID tranducer). Transducers (probes) can be swapped between devices without requiring recalibration to a specific OtoRead device. OtoRead will automatically detect...

  • Page 23: Operating Instructions

    OtoRead™ Instructions for Use - US Page 17 3 Operating instructions General precautions When operating the instrument, please observe the following general precautions: WARNING 1. Use this device only as described in this manual. 2. Use only the disposable Sanibel ear tips designed for use with this instrument.

  • Page 24: Battery Charge Status Indicator

    Calibration reminder The Otoread comes with a calibration reminder to remind you that the yearly calibration of the device will be required soon. The calibration reminder will be prompted when the OtoRead is switched on. Battery charge status indicator When the OtoRead battery’s power capacity becomes low, the first...

  • Page 25: General

    OtoRead™ Instructions for Use - US Page 19 Preparing the patient for testing Otoscopic examination of the patient’s ear canals should be performed prior to testing. Excessive cerumen or vernix in the ear canals may interfere with the test and give invalid or incomplete results. Patients with excessive cerumen, debris, or foreign bodies in the ear canals should be referred to an audiologist or physician for removal of the blockage prior to testing.

  • Page 26: The Probe Tube

    OtoRead™ Instructions for Use - US Page 20 The probe tube Probe tubes are disposable and should be replaced when they become clogged. A package of replacement probe tubes is included with this instrument. Do not attempt to clean the probe tube.

  • Page 27: Selecting The Test Protocol

    OtoRead™ Instructions for Use - US Page 21 Performing the test Selecting the Test Protocol The currently selected protocol is shown on the Main Menu. To change the selected protocol press CHANGE at the Main Menu. The Change Protocol Display will appear.

  • Page 28: Select The Test Ear

    Calibration after probe check Immediately after the probe check, the OtoRead will automatically perform a calibration prior to the start of each test. During calibration a series of tones will be presented to the ear canal to calibrate the levels of the frequencies to be tested.

  • Page 29: Testing Children With Pe Tubes

    Starting a new test for the same ear will overwrite the existing test. See the next section Managing Results on page 24 for more information on how the OtoRead saves results. See the section Instrument Settings – Save Mode on page 40 for more information on the OtoRead save mode options.

  • Page 30: Viewing Results

    OtoRead™ Instructions for Use - US Page 24 Viewing results When testing is complete, the green ’READY’ light is illuminated and a display similar to Main Menu will appear. This screen again indicates the test ear and also gives the results of the test.

  • Page 31: Rounding Results

    OtoRead™ Instructions for Use - US Page 25 Rounding results The user needs to be aware that the SNR and single PASS criteria are calculated from the full internal precision of the instrument, and not from the values shown in the printout for the emission (TE) and noise floor (NF) estimates.

  • Page 32: General

    Page 26 Managing results General Users have the option of printing to the thermal printer or transferring results to the OtoRead PC Module. Each OtoRead will include one or more of these options. Your specific options will vary depending on the configuration of the system purchased.

  • Page 33: Printing To A Thermal Printer

    Data can be deleted using the Clear function in the System Menu (page 39) Through the PC module: • Data is deleted when new Patient Names are uploaded from the PC Module to the OtoRead warning is provided that data will be deleted) • Data can be deleted in the OtoRead...

  • Page 34: Connection To The Pc Module

    Plug the correct end (USB-A) of the cable into an available USB port on the computer and the correct end (Micro-USB) of the cable into the port found on the bottom of the OtoRead The OtoRead will detect the connection to the PC and wait for an action or communication from the PC Module.

  • Page 35: Menu Structure

    Please note that editing of the DPOAE and TEOAE settings is only available if either a TEOAE or DPOAE protocol has been selected. DPOAE Menu and TEOAE Menu are not accessible in the OtoRead Screening and Screening Plus Version. A dedicated flowchart can be found in the diagram below.
  • Page 36 OtoRead™ Instructions for Use - US Page 30...

  • Page 37: Date And Time Settings (Menu M1)

    OtoRead™ Instructions for Use - US Page 31 Date and time settings (menu M1) 3.11.3.1 Setting initial date and time When the OtoRead is first used, the correct date and time will need to be set on its internal clock. The date and time are listed on the test printout as day-month-year (e.g., 07-MAR-17).

  • Page 38: Device Settings (Menu M2)

    PAIR. While the device is pairing to the computer a notification will display on your computer ’Add a device’. Select this notification on your computer and enter PIN 1234. The first time the OtoRead Module is opened, select Detect Com Port to finalize the OtoRead connection. 3.11.4.2 Clearing test results The Test Results Clear menu allows the user to clear the test results stored in the unit without printing them.

  • Page 39: Power Mode

    When using the ‘250 test’ mode, it is important to keep a record of the test number for each patient. When 245 tests have been saved, the user will be warned that the memory is almost full. When the OtoRead unit reaches 250 saved tests, it will not allow any further testing.

  • Page 40: Minimum Value

    OtoRead™ Instructions for Use - US Page 34 3.11.4.5 Minimum value The Minimum (Amplitude) Value setting allows the user to set the unit to include minimum amplitude values in the pass/refer criterion. The OtoRead is set with this feature turned OFF when it is shipped from the factory.

  • Page 41: Language

    OtoRead™ Instructions for Use - US Page 35 3.11.4.8 Language The Language setting allows the user to select among several languages. To change the language, press the CHANGE key until the desired language is shown. Press NEXT to exit this menu.

  • Page 42: Customizing A Test Protocol

    OtoRead™ Instructions for Use - US Page 36 3.11.5.2 Customizing a test protocol To enter the DPOAE Menu: 1. Press CHANGE at the main menu. 2. Using the CHANGE buttons, select the DPOAE protocol you want to customize (the ’DP 4s’...

  • Page 43: Setting The Pass Snr Level

    OtoRead™ Instructions for Use - US Page 37 3.11.5.5 Setting the PASS SNR level n order to provide a PASS/REFER determination for each test, the PASS SNR must be set. This number refers to the number of decibels that the DPOAE signal must be above the noise to be considered a PASS at that frequency.

  • Page 44: Save Protocol

    OtoRead™ Instructions for Use - US Page 38 3.11.5.8 Save protocol Once all of the settings have been selected for the protocol, these settings can be saved by selecting the SAVE key. Press the DONE key to exit. Selection of DONE before saving will not save the selection made for the protocol.

  • Page 45: Setting The Averaging Time

    OtoRead™ Instructions for Use - US Page 39 3.11.6.3 Setting the averaging time The Averaging Time can be changed to one of five settings. The Averaging Time will have a significant impact on the time required to perform the test and on the signal-to-noise ratio (SNR). A 4 second average would produce a test in about 4 seconds.

  • Page 46: Reset Protocol

    OtoRead™ Instructions for Use - US Page 40 3.11.6.6 Reset protocol Selecting the RESET arrow key in the Reset Protocol menu will return the selected protocol settings to their original factory settings. Press the NEXT key to exit. This does not affect the instrument settings or the settings of any other protocol.

  • Page 47: Care And Maintenance

    OtoRead™ Instructions for Use - US Page 41 4 Care and maintenance General maintenance procedures It is recommended that routine check procedures are carried out weekly in full on all equipment in use. Checks 1-8 outlined below should be carriedout on the equipment on each day of use.
  • Page 48 It is important that the customer (distributor) fills out the RETURN REPORT every time a problem arises. This should also be done every time an instrument is returned to Interacoustics. (This of course also applies in the unthinkable worst case of death or serious deterioration to patient or user).
  • Page 49 This shall apply solely to the original purchaser. This warranty shall not apply to any subsequent owner or holder of the product. Furthermore, this warranty shall not apply to, and Interacoustics shall not be responsible for, any loss arising in connection with the purchase or use of any Interacoustics product that has been: •...
  • Page 50 OtoRead™ Instructions for Use - US Page 44...

  • Page 51: Troubleshooting

    Try again • Paired to PC Computer or dongle: Check that the serial port is open. Establish that the serial port is handled by the PC and/or the software, not by the OtoRead instrument • BT Error Check BT device (printer or PC) status •...
  • Page 52 User should refit the probe and retry the test • Replace the probe tube • Contact Interacoustics or your local distributor for service if the problem persists across several patients • Fit Error For a DP test, the level of the calibration tone is too high. User...

  • Page 53: General Technical Specifications

    6 General technical specifications OtoRead hardware – Technical specifications Medical CE- The CE-mark indicates that Interacoustics A/S meets the requirements of Annex II of the Medical mark Device Directive 93/42/EEC. Approval of the quality system is made by TÜV – identification no0123...
  • Page 54 OtoRead™ Instructions for Use - US Page 48 DPOAE Stimulus Frequency range: 1500 to 12000 Hz Nominal frequency: Level: 40 - 70 dB SPL Level Step: 1 dB Transducer: Probe auto detection, auto calibrated Recording Analysis time: 0.5 to 2 sec.
  • Page 55 OtoRead™ Instructions for Use - US Page 49 Reference equivalent threshold values for transducer Table 2: Frequency and Intensity with G.R.A.S. RA0045 OES Output Minimum Maximum Minimum Maximum Frequency (Hz) Frequency (Hz) Frequency (Hz) Magnitude (dB SPL) Magnitude (dB SPL) 732.4...
  • Page 56 OtoRead™ Instructions for Use - US Page 50 Electromagnetic compatibility (EMC) WARNING • This instrument is suitable in hospital environments except for near active HF surgical equipment and RF shielded rooms of systems for magnetic resonance imaging, where the intensity of electromagnetic disturbance is high •...
  • Page 57 The OtoRead is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the OtoRead can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF...
  • Page 58 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The OtoRead is intended for use in the electromagnetic environment specified below. The customer or the user of the OtoRead should ensure that it is used in such an environment. Immunity Test IEC 60601 Test...
  • Page 59 If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the OtoRead (b*) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
  • Page 60 OtoRead™ Instructions for Use - US Page 54...
  • Page 61 OtoRead™ Instructions for Use - US Page 55 7 Appendices Appendix A: test sequence A complete test sequence consists of a probe check, calibration, and test phase. The probe check phase determines when the calibration phase should proceed, while the calibration phase calibrates the level of the tones that will be applied during the actual test phase.
  • Page 62 OtoRead™ Instructions for Use - US Page 56 Appendix B: test sequence Pass/Refer criteria for DPOAE The decision that a DPOAE exists is based on detecting a signal whose level is significantly above the background noise level. This requires a statistical decision, since the random noise level in the DPOAE filter channel can be expected to exceed the average of the random noise levels in the four adjacent filter channels —...
  • Page 63 Please note: The SNR limits for transients are lower than the corresponding limits for distortion products primarily because the traditional noise calculation used in TEOAE measurements (and in the OtoRead instrument) gives a 3 dB lower SNR than the calculation used for DPOAEs. Without that difference, the numerical SNR value for a PASS with the two methods would be quite similar.
  • Page 64 OtoRead™ Instructions for Use - US Page 58 Appendix C: Configurations and test protocols DPOAE protocols Protocolname # of F2 Freq. [kHz] L1/L2 Averaging Pass SNR # Passing Freq. Time [s] [dB] Freq. for Test Pass Screening DP 2s 2, 3, 4, 5...
  • Page 65 Other : Date : Person : Please provide e-mail address or fax No. to whom Interacoustics may confirm reception of the returned goods: The above mentioned item is reported to be dangerous to patient or user In order to ensure instant and effective treatment of returned goods, it is important that this form is filled in and placed together with the item.

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