Maico ERO-SCAN Operating Instructions Manual
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Summary of Contents for Maico ERO-SCAN
- Page 1 Operating Instruction ® ERO•SCAN Screening and Diagnostic Version MAICO Diagnostic GmbH, Salzufer 13/14, 10587 Berlin, Germany, Tel. +49 30-70 71 46 50, Fax +49 30-70 71 46 99...
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Page 3: Table Of Contents
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version Table of Contents 1 Standards Compliance ................1 2 Warranty ....................2 Intended Use ............................2 3 Warnings, Cautions, and Errors .............. 3 Status/Error Messages .........................5 4 Customer Responsibility ................6 5 Safety Precautions ................... 7 Cautions –... - Page 4 Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 10.4 Main Menu ............................19 10.5 Selecting the Test Protocol ....................... 19 10.6 Probe Check (Beginning a Test) ......................20 10.7 Calibration and Test .......................... 21 10.8 Viewing Results ..........................22 10.9 Test Technique..........................
- Page 5 Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 17.6 Clock Mode ............................41 17.7 Graph Style ............................41 17.8 Language ............................42 17.9 Reset to Default ..........................42 18 Advanced Options for DPOAE Testing ..........43 18.1 Instructions for Customizing a Test Protocol ..................43 18.2 Selecting the Level of Primary Tones ....................
- Page 6 Operating Instruction ® ERO•SCAN Screening and Diagnostic Version Electromagnetic Compatibility ......................64 Electrical Safety, EMC and Associated Standards ................64 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions ........65 Recommended Separation Distances between Portable and Mobile RF Communications ® Equipment and the ERO•SCAN .......................
- Page 7 Internet: www.maico-diagnostic. biz EC REP Copyright © 2014 MAICO Diagnostic. 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.
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Page 8: Standards Compliance
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 1 Standards Compliance Issue Standard Date Title ANSI/ASA 3.6 2010 Specification for Audiometers IEC 60601-1 2007 Medical Electrical Equipment – General Requirements for Basic Safety and Essential Performance, Ed. 3 IEC 60645-1 2004 Electroacoustics –... -
Page 9: Warranty
NOTE: Changes in the product not approved by MAICO Diagnostics shall void this warranty. MAICO Diagnostics shall not be liable for any indirect, special or consequential damages, even if notice has been given of the possibility of such damages. -
Page 10: Warnings, Cautions, And Errors
ERO•SCAN power supply and an AC outlet. No modifications of the equipment are allowed by anyone other than a qualified MAICO representative. Modification of the equipment could be hazardous. ® The ERO•SCAN product has been verified by an independent laboratory to conform to international standards for EMC (electromagnetic emissions and immunity). - Page 11 Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 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. Connection of accessories not meeting these requirements may result in electrical leakage currents in excess of those allowed by the standard and present a potential electrical shock hazard to the person being...
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Page 12: Status/Error Messages
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 3.1 Status/Error Messages Display Messages: Attach Probe No probe is detected at the start of a test. ® BT Device Not The paired Bluetooth device cannot be detected. The device may be turned off or too far away. -
Page 13: Customer Responsibility
Should the user suspect fluids have contacted the system components or accessories, the unit should not be used until deemed safe by a MAICO certified service technician. Do NOT use in the presence of flammable gaseous mixtures. Users should consider the possibility of explosions or fire when using this device in close proximity to flammable anesthetic gases. -
Page 14: Safety Precautions
MAICO published specifications. Use only the disposable eartips designed for use with this instrument. Never insert the probe tube into the ear canal without affixing an eartip. -
Page 15: Warning - Electric Shock Hazards
5.5 Warning - Battery Safety This instrument contains a rechargeable lithium-ion battery. The battery WARNING is not user replaceable and must be returned to an authorized MAICO service location for repair. 5.6 Warning - General Proper use of this device depends on careful reading of all instructions. -
Page 16: Recycling/Disposal
Below is the contact address for proper return or disposal of electronic wastes relating to MAICO products in in Europe and other localities. MAICO Diagnostic GmbH Salzufer 13/14... -
Page 17: Regulatory Symbols
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 7 Regulatory Symbols Symbol IEC Pub. Description 980 & 60601-1 Serial Number 980 & 60601-1 Date of Manufacture 980 & 60601-1 Manufacturer Caution, Consult Accompanying 980 & 60601-1 Documents Return to Authorized Representative, 980 &... - Page 18 Operating Instruction ® ERO•SCAN Screening and Diagnostic Version operating_instructions_8106556-6_EROSCAN_e_15a 8106556-5 02/15...
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Page 19: Introduction
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 8 Introduction ® The purpose of the ERO•SCAN test system is to provide a rapid measurement and documentation of Distortion Product Otoacoustic Emissions (DPOAEs) or Transient Evoked Otoacoustic Emissions (TEOAEs) at several frequencies. ®... -
Page 20: How Are The Results Stored And Reported
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 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, ®... -
Page 21: Setup
If any of these parts are missing or you want to order optional accessories or Sanibel disposables, contact your special equipment distributor or MAICO Diagnostic at (+49) 30 70 71 46-50. We recommend that you save the shipping box and packing materials in case you need to store or ship the system. - Page 22 Operating Instruction ® ERO•SCAN Screening and Diagnostic Version operating_instructions_8106556-6_EROSCAN_e_15a 8106556-5 02/15...
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Page 23: Installing The Micro-Probe
Micro-Probe connector ® into the socket on the top of the 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. Figure 4 operating_instructions_8106556-6_EROSCAN_e_15a... -
Page 24: Attaching Eartips
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 9.4 Attaching Eartips ® The ERO•SCAN instrument comes with a box of disposable eartips that fit a variety of ear canal sizes. The probe tube must have an eartip attached before inserting it into an ear canal. The determination of the appropriate eartip size should be made by persons with proper training and experience. -
Page 25: Operating Instructions
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 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. -
Page 26: Operating_Instructions_8106556-6_Eroscan_E_15A I 8106556-5
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 10.4 Main Menu Selected Protocol Battery Status Date & Time Start Right Start Left Ear Test Ear Test Display 1 Change Protocol and Settings 10.5 Selecting the Test Protocol The currently selected protocol is shown on the Main Menu (Display 1). -
Page 27: Probe Check (Beginning A Test)
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 10.6 Probe Check (Beginning a Test) To obtain a seal and measure emissions, gently insert the eartip into the patient’s ear canal. 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: Calibration And Test
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version NOTE: To test children with PE tubes, the AutoStart needs to be disabled. This is accomplished by first inserting the probe with appropriate eartip into the ear canal and obtaining a proper seal. -
Page 29: Viewing Results
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 10.8 Viewing Results When testing is complete, a Display similar to Display 8 will appear. The results of the test are automatically saved in memory as soon as the test is complete. The results will be saved even if the unit turns off or the batteries are temporarily depleted. -
Page 30: Noise Sources
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version ® When testing an infant with the ERO•SCAN instrument, the infant has to be relatively quiet and calm; it is usually preferred for the infant to be asleep. A pacifier may be used to calm the infant, however, sucking will add noise to the test and decrease the likelihood of a passing result. -
Page 31: Managing Results
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 11 Managing Results Users have the option of printing to the thermal printer or transferring results to the ® ® ERO•SCAN PC Database. Each ERO•SCAN system will include one or more of these options. -
Page 32: Deleting Results
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 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 or downloaded to the ERO•SCAN Database Software. -
Page 33: Connecting To The Pc Database Software
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version ® The ERO•SCAN will search for the paired printer showing Display 10 while searching. When the printer is found, all the test results that are stored in memory will print out automatically. ®... -
Page 34: Mpt-Ii Mobile Thermal Mini Printer
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 12 MPT-II Mobile thermal mini printer Cautions RISK OF EXPLOSION IF BATTERY IS REPLACED BY AN INCORRECT TYPE. CAUTION DISPOSE OF USED BATTERIES ACCORDING TO LOCAL REGULATIONS. Do not place the battery in fire or heat the battery. ... -
Page 35: Operation
Open the lid by pushing on the sides, insert paper roll as shown, and close the lid (Figure 9). Figure 9 NOTE: Reorder paper from Maico or your local distributor. Battery pack insertion: Insert battery as shown (Figure 10). Figure 10... - Page 36 Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 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 powered Slow flash...
- Page 37 Operating Instruction ® ERO•SCAN Screening and Diagnostic Version NOTE: Do not have several printers powered on and within range while searching. It is possible to pair up to 8 instruments with one printer. If more instruments are paired the oldest will be deleted. ®...
- Page 38 Operating Instruction ® ERO•SCAN Screening and Diagnostic Version Technical specifications Print mode: Power supply / charger: Thermal line dot print 12 V/1 A UE15WCP1-120125SPA Printing width: 48 mm (1.9 in.) Maximum current consumption 0.5 A Resolution: 8 dots/mm (203 dots per See also Figure 12.
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Page 39: Interpreting Results
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 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
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 13.2 SNR Graph View Display 11 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
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 14 Interpreting Printed Results ® Results from the ERO•SCAN can be transferred to a portable thermal printer or the ® ERO•SCAN Database Software for a full page printout. The information, as specified in section 14.1 and 14.2, is included on both printouts. -
Page 42: Understanding The Teoae Printout
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 14.2 Understanding the TEOAE Printout The following information is provided for each test (Figure 15): 1) The software version number (e.g.: V100.01) 2) The time and date of the test, based on the setting of the internal clock;... -
Page 43: Rounding Results
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 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/Time Settings
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 16 Clock and Date/Time Settings ® When the ERO•SCAN test instrument 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-14). -
Page 45: Instrument Settings
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 17 Instrument Settings ® The ERO•SCAN instrument allows the user to change many of the instrument's settings or ® functions. These settings include Bluetooth 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
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version When pairing to a computer for use with the Database Manager Software, confirm the computer has Bluetooth ® availability or a Bluetooth ® dongle will be required. Confirm the ® ® Bluetooth settings of the computer ‘Allow Bluetooth devices to find this PC (See Figure 16). -
Page 47: Save Mode/Storing Test Results
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version seconds, 1, 2, or 4 minutes. Once you have made your selection, press NEXT. 17.4 Save Mode/Storing Test Results ® The ERO•SCAN unit automatically stores only the most recent test result for each ear L/R (Display 21), but has the capacity to store 250 individual tests. -
Page 48: Minimum Amplitude
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 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 23). The ERO•SCAN is set with this feature turned OFF when it is shipped from the factory. -
Page 49: Language
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 17.8 Language The Language setting (Display 26) allows the user to select among several languages. To change the language, press the CHANGE keys until the desired language is shown. Press NEXT to exit this menu. Display 26 17.9 Reset to Default The Reset to Default menu (Display 27) will return all instrument... -
Page 50: Advanced Options For Dpoae Testing
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 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 The Advanced Options menus permit modification of the test parameters and pass criteria for the customizable DP protocols. -
Page 51: Selecting The Level Of Primary Tones
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version Selecting the Level of Primary TonesThe 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... -
Page 52: Setting The Number Of Frequencies For Pass
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 18.4 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. -
Page 53: Instructions For Customizing A Test Protocol
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 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 The Advanced Options menu permits modification of the test stimuli and measurement values for the TE Custom Protocol. -
Page 54: Selecting The Averaging Time
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 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). -
Page 55: Setting The Number Of Frequencies For Pass
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 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. -
Page 56: Cleaning And Maintenance
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 20 Cleaning and Maintenance 20.1 Cleaning and Disinfection Use new eartips for each patient. Eartips are for single patient use only. 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 57: Probe Tube Replacement
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 58: 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 59 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 60 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.
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Page 61: Specifications
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 22 Specifications MICRO-PROBE SPECIFICATIONS Measurement Type: Distortion Product Otoacoustic Emissions (DPOAE) Transient Evoked Otoacoustic Emissions (TEOAE) Frequency Range: Screener version: DPOAE: 2.0 kHz to 5.0 kHz TEOAE: 1.5 kHz to 4.0 kHz Diagnostic version: DPOAE: 1.5 kHz to 12.0 kHz TEOAE: 0.7 kHz to 4.0 kHz... - Page 62 Operating Instruction ® ERO•SCAN Screening and Diagnostic Version POWER SUPPLY SPECIFICATIONS (use only approved power supply) Model No: UE08WCP-050160SPA Output: 5.0 V DC, 1.6 A Input 100 V-240 V AC, 50 Hz - 60 Hz, 400 mA ENVIRONMENTAL REQUIREMENTS Operating Temperature: 15 °...
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Page 63: Appendix A: Flowcharts
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version Appendix A: Flowcharts A.1 Test Operation Flowchart operating_instructions_8106556-6_EROSCAN_e_15a 8106556-5 02/15... -
Page 64: Setup Menu Flowchart
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version A.2 Setup Menu Flowchart ® NOTE: DPOAE Menu and TEOAE Menu are not accessible in the ERO•SCAN Screening version. operating_instructions_8106556-6_EROSCAN_e_15a 8106556-5 02/15... -
Page 65: Appendix B: Test Sequence
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version Appendix B: 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. Artifact rejection is employed during the test phase to reduce the effect of transient noise bursts. - Page 66 Operating Instruction ® ERO•SCAN Screening and Diagnostic Version lower the noise floor of the test. In order to reduce the possibility of obtaining an artificially low noise floor, the minimum threshold level is limited. Comment about Variations in the SNR Estimate The user needs to be aware that the SNR estimate has an inherent statistical variation due to the effects of random noise, especially when no emission is actually present.
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Page 67: Appendix C: Pass/Refer Criteria
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version Appendix C: Pass/Refer Criteria 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 68 Operating Instruction ® ERO•SCAN Screening and Diagnostic Version Diagram 1 Pass/Refer Criteria for TEOAE The same basic principles that underlie DPOAE Pass/Fail criteria underlie TEOAE Pass/Fail criteria. In the case of transients, requiring SNR of 4 dB at any three out of the six test frequencies drops the probability of passing an ear with a significant hearing loss to less than 1 %.
- Page 69 Operating Instruction ® ERO•SCAN Screening and Diagnostic Version The artifact rejection can only reject the noisiest samples in a measurement period. If the ambient noise level rises too high (and/or the eartip seal is poor), then all samples will be noisy and accurate measurements will be impossible, in which case the test result will indicate “noisy”.
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Page 70: Appendix D: Configurations And Test Protocols
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version Appendix D: Configurations and Test Protocols DPOAE Protocols # of Averagin Pass # Passing Freq. Name Freq. F2 Freq. [kHz] L1/L2 g Time for Test Pass Screening DP 4s 2, 3, 4, 5 65/55 4 sec 6 dB... -
Page 71: Appendix E: 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 72: Guidance And Manufacturer's Declaration - Electromagnetic Emissions
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 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 73: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 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 74: Guidance And Manufacturer's Declaration - Electromagnetic Immunity
Operating Instruction ® ERO•SCAN Screening and Diagnostic Version 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 75 Operating Instruction ® ERO•SCAN Screening and Diagnostic Version Specifications are subject to change without notice MAICO Diagnostic GmbH Salzufer 13/14 10587 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...