Maico ERO-SCAN Operation Manual
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Maico ERO-SCAN Operation Manual

Screening and diagnostic version
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Operation Manual
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ERO•SCAN
Screening and Diagnostic Version

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Summary of Contents for Maico ERO-SCAN

  • Page 1 Operation Manual ERO•SCAN Screening and Diagnostic Version...

  • Page 3: Table Of Contents

    Operation Manual ERO•SCAN Table of Contents Trademark Notice ....................4 Standards Compliance ..................5 Warranty ......................6 Intended Use .................... 6 Indications for Use ................... 6 Contraindications for Use ................ 7 Essential Performance ................7 Warnings, Cautions and Errors ............... 8 Status/Error Messages ................
  • Page 4 Operation Manual ERO•SCAN 10 Operating Instructions ..................23 10.1 Preparing the Patient for Testing ............23 10.2 Turning On the Instrument ..............23 10.3 Control Panel ..................23 10.4 Main Menu ..................... 24 10.5 Selecting the Test Protocol ..............24 10.6 Probe Check (Beginning a Test) ............
  • Page 5 Operation Manual ERO•SCAN 17.3 Auto Shutdown Time ................44 17.4 Save Mode/Storing Test Results............45 17.5 Minimum Amplitude ................46 17.6 Clock Mode ................... 46 17.7 Graph Style .................... 46 17.8 Boys Town Norms ................. 47 17.9 Language ....................47 17.10 Reset to Default ..................

  • Page 6: Trademark Notice

    Copyright © 2018 MAICO Diagnostics All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means without the prior written permission of MAICO. The information in this publication is proprietary to MAICO.

  • Page 7: Standards Compliance

    Operation Manual ERO•SCAN 1 Standards Compliance Issue Standard Date Title ANSI/ASA 3.6 2010 Specification for Audiometers ANSI/AAMI 2005 Medical Electrical Equipment – General Requirements for Basic 60601-1 Safety and Essential Performance, Ed. 3 IEC 60645-1 2012 Electroacoustics - Audiological equipment -- Part 1: Pure-tone audiometers IEC 60645-3 2007...

  • Page 8: Warranty

    For assistance with this ERO•SCAN Otoacoustic Emission Test System contact your Special Equipment Distributor or contact MAICO Diagnostics by phone at + 49 30 / 70 71 46-50 or by fax at + 49 30 / 70 71 46-99. 2.1 Intended Use The ERO•SCAN...

  • Page 9: Contraindications For Use

    Operation Manual ERO•SCAN 2.3 Contraindications for Use Testing should not be performed on patients with one of the following symptoms without a medical doctor’s approval: • Recent stapedectomy or other middle ear surgery • Discharging ear • Acute external auditory canal trauma •...

  • Page 10: Warnings, Cautions And Errors

    Equipment is not user repairable. Repairs must be performed by a qualified service representative only. No modifications of the equipment are allowed by anyone other than a qualified MAICO representative. Modification of the equipment could be hazardous. No part of the equipment can be serviced or maintained while in use with the patient.

  • Page 11: Status/Error Messages

    Operation Manual ERO•SCAN CAUTION US federal law restricts this device to sale by or on the order of a physician or licensed hearing care professional. Instruments which bear the Underwriters Laboratories, Inc. label should be interconnected with accessories that have the proper electrical compatibility and are listed as meeting the requirements of the UL Medical and Dental Equipment Standard.
  • Page 12 Operation Manual ERO•SCAN Printer Paper Out! Indicates that printer paper has run out. Time/Date Error The clock is checked during power on to ensure it has not lost time and been reset. In the case of clock reset, this message is shown. The user should set the correct date/time.

  • Page 13: Customer Responsibility

    Operation Manual ERO•SCAN 4 Customer Responsibility NOTE: In the unlikely case of a serious incident, inform MAICO as well as your local distributor. This product and its components will perform reliably only when WARNING operated and maintained in accordance with the instructions contained in this manual, accompanying labels, and/or inserts.

  • Page 14: Safety Precautions

    If the system is not functioning properly, do not operate it until all WARNING necessary repairs are made and the unit is tested and calibrated for proper functioning in accordance with MAICO published specifications. Use only the disposable eartips designed for use with this instrument.

  • Page 15: Warning - Electric Shock Hazards

    WARNING flammable anesthetics or other gases. 5.5 Warning - Battery Safety This instrument contains a rechargeable lithium-ion battery. The battery is not user replaceable and must be returned to an authorized MAICO WARNING service location for repair. 26/11/2018 8106556 Rev. 10...

  • Page 16: Warning - Pc-Connection

    Operation Manual ERO•SCAN 5.6 Warning – PC-Connection Safety against electrical hazard is guaranteed only when the WARNING connected notebook computer is powered by batteries respectively the computer´s power supply accords to the IEC 60601-1 or IEC 60950-1 safety regulations. To transfer data to a PC, establishing a PC-connection via USB is WARNING required.

  • Page 17: Recycling/Disposal

    Operation Manual ERO•SCAN 6 Recycling/Disposal Many local laws and regulations require special procedures to recycle or dispose of electrical equipment-related waste including batteries, printed circuit boards, electronic components, wiring and other elements of electronic devices. Follow all your respective local laws and regulations for the proper disposal of batteries and any other parts of this system.

  • Page 18: Regulatory Symbols

    Operation Manual ERO•SCAN 7 Regulatory Symbols REGULATORY SYMBOLS SYMBOL DESCRIPTION Serial number Date of manufacture Manufacturer Caution, consult accompanying documents Warning, consult accompanying documents Return to authorized representative, special disposal required Reference number Patient applied part type B according to IEC 60601-1 Refer to instruction manual (mandatory) Keep away from rain Transport and storage temperature range...

  • Page 19: Introduction

    Operation Manual ERO•SCAN 8 Introduction The purpose of the ERO•SCAN test system is to provide a rapid measurement and documentation Distortion Product Otoacoustic Emissions (DPOAEs) Transient Evoked Otoacoustic Emissions (TEOAEs) at several frequencies. The ERO•SCAN is available as a Screening or Diagnostic version. Please see chapter 18 and 19 for further information.

  • Page 20: How Are The Results Stored And Reported

    Operation Manual ERO•SCAN 8.2 How are the Results Stored and Reported? When the ERO•SCAN is set in its default settings, the instrument will store the results from one patient (left and right ear) in its non-volatile memory for subsequent printing. However, the ERO•SCAN instrument is capable of storing up to 250 test results.

  • Page 21: Setup

    Operation Manual ERO•SCAN 9 Setup 9.1 Unpacking the System Check Box and Contents for Damage • ERO•SCAN It is recommended that you unpack your carefully making sure that all components are removed from the packing materials. • Verify that all components are included as shown on the packing slip included with your shipment. •...

  • Page 22: Battery Charging

    NOTE: Misalignment of the plug and socket can cause damage. The plug and socket should be visually inspected prior to each installation Figure 2 of the charging cable. If damage is observed, contact MAICO Diagnostics. The indicator labeled ‘CHARGE’ (Figure 3) provides a visual indication (BLUE) of the battery recharging function and battery status during operation.

  • Page 23: Installing The Micro-Probe

    ERO•SCAN (Figure 4). The plug will fit in only one direction. A MAICO logo is on the probe connector and will align with the instrument control panel. NOTE: Misalignment of the plug and socket can cause damage. The...

  • Page 24: Establishing A Pc-Connection

    Operation Manual ERO•SCAN 9.7 Establishing a PC-Connection To transfer data to a PC, establishing a PC-connection via USB is required. If the ERO•SCAN used with office equipment that is not a medical device itself (see Table 1, PC-Connection 1), make sure to establish the PC-connection in one of the following ways (see Table 1, PC Connection 2, 3 or 4).

  • Page 25: Operating Instructions

    Operation Manual ERO•SCAN 10 Operating Instructions 10.1 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 a qualified professional for removal of the blockage prior to testing.

  • Page 26: Main Menu

    Operation Manual ERO•SCAN 10.4 Main Menu Selected Protocol Date & Time Battery Status Save Mode and Test # Start Right Start Left Ear Test Ear Test Display 2 Change Protocol and Settings 10.5 Selecting the Test Protocol The currently selected protocol is shown on the Main Menu (Display 2).

  • Page 27: Probe Check (Beginning A Test)

    Operation Manual ERO•SCAN 10.6 Probe Check (Beginning a Test) To obtain a seal and measure emissions, gently insert the eartip into the patient’s ear canal (Figure 9). It should fit snugly and comfortably. The best test results are obtained when an eartip is inserted deeply into the ear canal instead of flush with the ear canal.

  • Page 28: Viewing Results

    Operation Manual ERO•SCAN The ERO•SCAN instrument will automatically perform a calibration prior to the start of each test. During calibration test signals will be presented to the ear canal to calibrate the levels of the frequencies to be tested. Following calibration of the test signals, the test phase will begin automatically.

  • Page 29: Test Technique

    Operation Manual ERO•SCAN determine from the printout whether the test should be repeated. To review the results, push the DOWN arrow key to return to the graph. After reviewing the results, push the UP arrow key to return to the Main Menu (Display 2, page 23). NOTE: Completed tests are automatically saved.

  • Page 30: Teoae And Pause Function

    Operation Manual ERO•SCAN 10.11 TEOAE and Pause Function The ERO•SCAN instrument incorporates a pause function within the TEOAE test when a leak is detected. When the detection occurs, all three LED lights at the top of the device (Noise, Test and Ready) will illuminate to display the device is in pause mode.

  • Page 31: Managing Results

    Operation Manual ERO•SCAN 11 Managing Results Users have the option of printing to the thermal printer or transferring results to the PC. Each ERO•SCAN system will include one or more of these options. Your specific options will vary depending on the configuration of the system purchased. 11.1 Saving Results The ERO•SCAN...

  • Page 32: Deleting Results

    Operation Manual ERO•SCAN 11.2 Deleting Results The ERO•SCAN holds data in non-volatile memory. The data stays in the memory even after data is printed by the thermal printer, printed with the Direct-to-Print Software or downloaded to the ERO•SCAN Database Software. Data can be deleted through a few methods, depending on the Save mode.

  • Page 33: Connecting To The Pc Database Software

    Operation Manual ERO•SCAN The ERO•SCAN instrument will power off when printing is complete. NOTE: All printed test results are marked for deletion, but will continue to be stored in memory until a new test is started at which time all tests in the memory will be erased. This allows the user to reprint the tests if printing is unsuccessful (for example, the paper runs out before printing is complete).

  • Page 34: Connecting To The Direct-To-Print Software

    Operation Manual ERO•SCAN 11.5 Connecting to the Direct-to-Print Software Connection to the Direct-to-Print Software is achieved by using the provided Micro-USB to USB- A cable only. USB Connection: 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 ERO•SCAN instrument.

  • Page 35: Mpt-Ii Sanibel Mobile Thermal Mini Printer

    Operation Manual ERO•SCAN 12 MPT-II SANIBEL Mobile thermal mini printer • RISK OF EXPLOSION IF BATTERY IS REPLACED BY CAUTION AN INCORRECT TYPE. • DISPOSE OF USED BATTERIES ACCORDING TO LOCAL REGULATIONS. • Do not place the battery in fire or heat the battery. •...

  • Page 36: Operation

    Open the lid by pushing on the sides, insert paper roll as shown, and close the lid (Figure 10). Figure 10 NOTE: Reorder paper from MAICO or your local distributor. Battery pack insertion: Insert battery as shown (Figure 11). Figure 11...
  • Page 37 Operation Manual ERO•SCAN Indicators: Green LED indicator Blue LED indicator Status Sound Note Fast flash Charging Power On Charging Power Off Battery nearly Slow flash discharged Charging Power On completed Charging Power Off completed Power ON, battery Slow flash Slow flash Out of paper Beep Slow flash...
  • Page 38 Operation Manual ERO•SCAN NOTE: Do not have several printers powered on and within range while searching. NOTE: See the chapter Wireless Device Pairing for detailed information. Technical specifications of Printer: Print mode: • Thermal line dot print • Printing width: 48 mm (1.9 in.) •...

  • Page 39: Interpreting Results

    Operation Manual ERO•SCAN 13 Interpreting Results 13.1 Understanding the Display The display on the ERO•SCAN test instrument will indicate the results of the test with a graphic display. The display will be generated and shown during the test and can be reviewed after the test is complete.

  • Page 40: Snr Graph View

    Operation Manual ERO•SCAN 13.2 SNR Graph View Display 13 shows the SNR bar graph view. These are the signal-to- noise ratio (SNR) test results which are displayed as the emissions and noise floor are measured. Each column represents one DP test frequency or TE frequency band.

  • Page 41: Interpreting Printed Results

    Operation Manual ERO•SCAN 14 Interpreting Printed Results Results from the ERO•SCAN can be printed in multiple ways. It is up to the examiner to select the appropriate method for their practice needs. The printing options include: 1. Thermal Printout: An optional wireless printer can be purchased for immediate printing to a thermal printer.
  • Page 42 Operation Manual ERO•SCAN The following information is provided for each test (Figure 16): 1) Manufacture Logo 2) The software version number (e.g.: V105.05) 3) The time and date of the test, based on the setting of the internal clock; if the clock is set correctly, this time and date will be correct 4) The test number (if operating in “Save 250”...

  • Page 43: Rounding Results

    Operation Manual ERO•SCAN 15 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 44: Clock And Date Settings

    Operation Manual ERO•SCAN 16 Clock and Date Settings When the ERO•SCAN test instrument is first used, the correct date and time may 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-14).

  • Page 45: Instrument Settings

    Operation Manual ERO•SCAN 17 Instrument Settings The ERO•SCAN instrument allows the user to change many of the instrument's settings or functions. These settings include Wireless Device Pairing, Clearing Test Results, Auto Shutdown Time, Minimum Amplitude Value, Save Mode, Clock Mode, Language, and Reset to Default Settings.

  • Page 46: Clearing Test Results

    Operation Manual ERO•SCAN When pairing to a computer for use with the Database Manager Software, confirm the computer has wireless connectivity availability or a dongle will be required. Confirm the wireless settings of the computer (See Figure 18). Figure 18 Wireless Connection Settings Select the wireless pairing Menu (Display 18, page 43) and press DISCOVER...

  • Page 47: Save Mode/Storing Test Results

    Operation Manual ERO•SCAN The Auto Shutdown time may be increased or decreased by pressing the CHANGE keys. The times available are 30 seconds, 1, 2, or 4 minutes. Once you have made your selection, press NEXT. NOTE: The device will Power Off immediately following a printout independent of Power Off setting.

  • Page 48: Minimum Amplitude

    Operation Manual ERO•SCAN 17.5 Minimum Amplitude The Minimum Amplitude setting allows the user to set the unit to include minimum amplitude values in the pass/refer criterion (Display 25). The ERO•SCAN is set with this feature turned OFF when it is shipped from the factory. If the MIN VALUE is set to “ON”, a result is not considered a pass unless the amplitude at each frequency is equal to or greater than the minimum value programmed into the unit.

  • Page 49: Boys Town Norms

    Operation Manual ERO•SCAN 17.8 Boys Town Norms The Norms setting (Display 28) allows the user to show the Boys Town Norms on the device when in Value Graph mode. This display will be visible in the Menu selection only if Value Graph is selected. If SNR Graph is selected, this menu screen will be hidden as it is not applicable to the SNR graph.

  • Page 50: Reset To Default

    Operation Manual ERO•SCAN 17.10 Reset to Default The Reset to Default menu (Display 30) will return all instrument settings and protocol settings to their original factory defaults. Select the LEFT or RIGHT arrow keys to reset and select YES or NO to verify reset. To exit the System menu without resetting the instrument, press NEXT to return to the Main Menu.

  • Page 51: Advanced Options For Dpoae Testing

    Operation Manual ERO•SCAN 18 Advanced Options for DPOAE Testing NOTE: The Advanced Options for DPOAE Testing section is reserved for those units purchased as a diagnostic device. Instruments purchased as a screener can skip to Section 20. The Advanced Options menu permit modification of the test parameters and pass criterion for the customizable DP protocols.

  • Page 52: Selecting The Level Of Primary Tones

    Operation Manual ERO•SCAN 18.2 Selecting the Level of Primary Tones The intensity of the primary tones (L1, L2) may be changed to any level between 40 dB SPL and 70 dB SPL. The level L1 will change in 1 dB increments by pushing the LEFT or RIGHT arrow keys (Display 32) and press NEXT to move to the L2 screen.

  • Page 53: Setting The Number Of Frequencies For Pass

    Operation Manual ERO•SCAN 18.5 Setting the Number of Frequencies for PASS The number of frequencies required for determining a PASS can be set from 0 to 12. If the setting is on 0, then no indication of PASS/REFER will be made. This setting is used in conjunction with the PASS SNR (Display 35) to set the criteria for the overall test PASS/REFER indication.

  • Page 54: Advanced Options For Teoae Testing

    Operation Manual ERO•SCAN 19 Advanced Options for TEOAE Testing NOTE: The Advanced Options for TEOAE Testing section is reserved for those units purchased as a diagnostic device. Instruments purchased as a screener can skip to Section 20. The Advanced Options menu permits modification of the test stimuli and measurement values for the TE Custom Protocol.

  • Page 55: Selecting The Averaging Time

    Operation Manual ERO•SCAN 19.2 Selecting 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 56: Setting The Number Of Frequencies For Pass

    Operation Manual ERO•SCAN 19.4 Setting the Number of Frequencies for PASS The number of frequencies for determining a PASS can be set from 0 to 6. If the setting is on 0, then no indication of PASS/REFER will be made. This setting is used in conjunction with the PASS SNR to set the criteria for the overall test PASS/REFER indication.

  • Page 57: Cleaning And Maintenance

    Operation Manual ERO•SCAN 20 Cleaning and Maintenance 20.1 Cleaning and Disinfection Use a new eartip for each patient. Eartips are for single patient use only. WARNING The probe tube, which does not make direct contact with the patient, should be replaced if there is any sign of contamination or if the test will not progress past the Probe Check phase.

  • Page 58: Maintenance

    Parts which may be broken or missing or are visibly worn, distorted or contaminated should be replaced immediately with clean, genuine replacement parts manufactured by or available from MAICO. Equipment is not user repairable. Repairs and battery replacement must be performed by a qualified service representative only.

  • Page 59: Troubleshooting

    If the test will not start or if the AutoStart tones sound unusual, replace the probe tube. • Contact MAICO for service if the problem persists across several patients. • Check the printer status. Turn the printer on (wake from sleep...
  • Page 60 User should refit the probe and retry the test. • Replace the probe tube. • Contact MAICO for service if the problem persists across several patients. • For a DP test, the level of the calibration tone is too high. User...
  • Page 61 Error User should repeat the test. • Cycle instrument power. • Contact MAICO for service if the problem persists. • Saved tests are within 5 tests of the maximum limit. Print or Memory almost full transfer test result to avoid interruption in testing.

  • Page 62: Specifications

    General Information About Specifications The performance and specifications of the device can only be guaranteed if it is subject to technical maintenance at least once per year. MAICO Diagnostics puts diagrams and service manuals at the disposal of authorized service companies. MICRO-PROBE SPECIFICATIONS...
  • Page 63 Operation Manual ERO•SCAN INSTRUMENT SPECIFICATIONS Battery: Lithium-Ion rechargeable Battery Life: 1000 tests per charge, minimum 15 hours on-time Dimensions and Weight: Dimensions: W x D x H: 65.5 mm x 31.2 mm x 146 mm (2.58 in. x 1.23 in.x 5.78 in.) Instrument Weight: 176 g (6.2 oz.) User Interface: OLED display to provide user information and progress of...

  • Page 64: Appendix A: Flowcharts

    Operation Manual ERO•SCAN Appendix A: Flowcharts A.1 Test Operation Flowchart 26/11/2018 8106556 Rev. 10...

  • Page 65: Setup Menu Flowchart

    Operation Manual ERO•SCAN A.2 Setup Menu Flowchart NOTE: DPOAE Menu and TEOAE Menu are not accessible in the ERO•SCAN Screening version. 26/11/2018 8106556 Rev. 10...

  • Page 66: Appendix B: Configurations And Test Protocols

    Operation Manual ERO•SCAN Appendix B: Configurations and Test Protocols DPOAE Protocols Passing Freq. for Freq. Averagin Pass Test Name Freq. [kHz] L1/L2 g Time Pass Screening DP 4s 2, 3, 4, 5 65/55 4 sec 6 dB DP 2s 2, 3, 4, 5 65/55 2 sec 6 dB...

  • Page 67: Appendix C: Emc Compatibility

    The use of accessories, transducers and cables other than those specified, with the exception of servicing parts sold by MAICO Diagnostics as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the device. Anyone connecting additional equipment is responsible for making sure the system complies with the IEC 60601-1-2 standard.
  • Page 68 Operation Manual ERO•SCAN Guidance and Manufacturer’s Declaration - Electromagnetic Emissions The ERO•SCAN is intended for use in the electromagnetic environment specified below. The customer or the user of the ERO•SCAN should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic environment - Guidance...
  • Page 69 Operation Manual ERO•SCAN Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The ERO•SCAN is intended for use in the electromagnetic environment specified below. The customer or the user of the ERO•SCAN should assure that it is used in such an environment. Immunity Test IEC 60601 Test Level Compliance...
  • Page 70 Operation Manual ERO•SCAN Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The ERO•SCAN is intended for use in the electromagnetic environment specified below. The customer or the user of the ERO•SCAN should assure that it is used in such an environment. Immunity Test IEC 60601 Test Compliance...
  • Page 71 Specifications are subject to change without notice MAICO Diagnostics GmbH Sickingenstr. 70-71 10553 Berlin Germany Tel.: + 49 30 / 70 71 46-50 Fax: + 49 30 / 70 71 46-99 E-mail: sales@maico.biz Internet: www.maico.biz...

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