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Operating Instruction  
ERO•SCAN

®

 

Screening and Diagnostic Version

 

 

operating_instructions_8106556-6_EROSCAN_e_15a 

 

10 

8106556-5   02/15 

 

 

7

 

Regulatory Symbols 

 
No. 

Symbol 

IEC Pub. 

Description 

 

 

980 & 60601-1  Serial Number 

 

 

980 & 60601-1  Date of Manufacture  

 

 

980 & 60601-1  Manufacturer 

 

 

980 & 60601-1 

Caution, Consult Accompanying 
Documents 

 

 

980 & 60601-1 

Return to Authorized Representative, 
Special Disposal Required 

 

 
 

980 & 60601-1  Reference Number 

 

 

60601-1 

B Patient Applied Part According to 
IEC60601-1 

 

 

 

980 & 60601-1  Consult Operating Instructions 

 

 

60601-1 

Keep Dry 

 

 

60601-1 

Transport and Storage Temperature 
range 

 

 

 

 

 

Logo 

 

EC REP

 

980 & 60601-1 

 

EU Authorized Representative 

 

 

 

980 & 60601-1 

 

Conforms to European Medical 
Device Directive 93/42/EEC  

 

REF 

Содержание ERO SCAN

Страница 1: ...MAICO Diagnostic GmbH Salzufer 13 14 10587 Berlin Germany Tel 49 30 70 71 46 50 Fax 49 30 70 71 46 99 Operating Instruction ERO SCAN Screening and Diagnostic Version...

Страница 2: ......

Страница 3: ...8 5 3 Warning In Case of Emergency 8 5 4 Warning Explosion 8 5 5 Warning Battery Safety 8 5 6 Warning General 8 6 Recycling Disposal 9 7 Regulatory Symbols 10 8 Introduction 12 8 1 How Does the ERO S...

Страница 4: ...mal Printer 25 11 4 Connecting to the PC Database Software 26 12 MPT II Mobile thermal mini printer 27 12 1 Operation 28 13 Interpreting Results 32 13 1 Understanding the Display 32 13 2 SNR Graph Vie...

Страница 5: ...Protocol 45 18 7 Save Protocol 45 19 Advanced Options for TEOAE Testing 45 19 1 Instructions for Customizing a Test Protocol 46 19 2 Selecting the Averaging Time 47 19 3 Setting the PASS SNR Level 47...

Страница 6: ...Electrical Safety EMC and Associated Standards 64 Guidance and Manufacturer s Declaration Electromagnetic Emissions 65 Recommended Separation Distances between Portable and Mobile RF Communications Eq...

Страница 7: ...et 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 writte...

Страница 8: ...5 3 2007 Electroacoustics Audiometric equipment Part 3 Test signals of short duration IEC 60645 6 2010 Electroacoustics Audiometric Equipment Part 6 Instruments for the measurement of otoacoustic emis...

Страница 9: ...OTHER WARRANTIES EXPRESSED OR IMPLIED INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE For assistance with this ERO SCAN Otoacoustic Emission Te...

Страница 10: ...sult when a three prong to two prong adaptor is connected between the ERO SCAN power supply and an AC outlet No modifications of the equipment are allowed by anyone other than a qualified MAICO repres...

Страница 11: ...mpatibility 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 current...

Страница 12: ...tests are within 5 tests of the maximum limit Memory Full The maximum saved test limit is reached The user will need to clear the memory before any additional tests can be performed Power Low The bat...

Страница 13: ...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 th...

Страница 14: ...to be used by hearing healthcare professionals i e ENT doctors audiologists and or technicians neonatal nurses and school nurses who have been trained by a hearing healthcare professional 5 1 Caution...

Страница 15: ...Warning In Case of Emergency In case of emergency disconnect the instrument from the supply mains by removing the micro USB cable from the connector as shown in Figure 2 on page 16 5 4 Warning Explos...

Страница 16: ...ements of electronic devices Follow all your respective local laws and regulations for the proper disposal of batteries and any other parts of this system Below is the contact address for proper retur...

Страница 17: ...nufacturer 980 60601 1 Caution Consult Accompanying Documents 980 60601 1 Return to Authorized Representative Special Disposal Required 980 60601 1 Reference Number 60601 1 B Patient Applied Part Acco...

Страница 18: ...Operating Instruction ERO SCAN Screening and Diagnostic Version operating_instructions_8106556 6_EROSCAN_e_15a 11 8106556 5 02 15...

Страница 19: ...they are printed The plastic housing contains circuit boards that provide the signal processing and Display the test results The instrument also contains a rechargeable lithium ion battery to power t...

Страница 20: ...latile memory so the operator can delay printing until a later time if desired 8 3 Sensitivity and Specificity Sensitivity and specificity of this type of device are based on the test characteristics...

Страница 21: ...tional 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...

Страница 22: ...Operating Instruction ERO SCAN Screening and Diagnostic Version operating_instructions_8106556 6_EROSCAN_e_15a 15 8106556 5 02 15...

Страница 23: ...of the charging function and is defined as follows Steady state illumination indicates that the battery is fully charged This identifies that the charging cycle has been completed or was not implement...

Страница 24: ...artips are disposable and should be replaced after each patient After selecting an eartip push it onto the probe tube until it is flush against the base of the probe tube Figure 5 Twisting the eartip...

Страница 25: ...ndicating the instrument is ready for use The Flash Screen will appear briefly This Display will indicate the type of instrument Screener SCR Screener Plus SC Standard STD or Combo CMB software versio...

Страница 26: ...e selected protocol Press the UP arrow to return to the Main Menu to begin testing Press the SETUP to enter the setup menus For either DPOAEs or TEOAEs screener devices there are two default test prot...

Страница 27: ...icates that the probe is not inserted into the ear or placed properly When the bars are all the way to the right Display 4 this represents the volume is too small for the test to begin or indicates th...

Страница 28: ...calibration of the test tones the test phase will begin automatically During the test phase a set of bars should appear on the Display Display 6 These are the test results which are displayed as the e...

Страница 29: ...nd retest If the test result is REFER the tester can 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 reviewin...

Страница 30: ...level in the ear canal is low and it will appear more often if the noise level in the ear canal is high Otoacoustic emissions are very low level sounds Any noise in the ear canal at the time of testin...

Страница 31: ...h patient in the default mode When operating in the Save 250 mode the ERO SCAN will save up to 250 tests There are two options in the Save 250 mode 1 The ERO SCAN will automatically number each test f...

Страница 32: ...ng is provided that data will be deleted Data can be deleted using the Clear function in the System Menu page 39 Data can be deleted in the ERO SCAN from the Database Software when the device is conne...

Страница 33: ...the paper runs out before printing is complete NOTE See the ERO SCAN Database Software Manual for instructions on printing from the Database Software 11 4 Connecting to the PC Database Software Connec...

Страница 34: ...on induction cookware In the event that the battery leaks and the fluid gets into one s eye do not rub the eye Rinse well with water and immediately seek medical care If left untreated the battery flu...

Страница 35: ...per roll as shown and close the lid Figure 9 NOTE Reorder paper from Maico or your local distributor Battery pack insertion Figure 10 Insert battery as shown Figure 10 Power on Push POWER BUTTON for t...

Страница 36: ...ode 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 pa...

Страница 37: ...ral 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 For detailed instructions...

Страница 38: ...m 2 2 in 0 04 in max 40 mm 1 6 in diameter Battery pack 2 cell Li Ion battery pack 7 4 V 1500 mAh Power supply charger 12 V 1 A UE15WCP1 120125SPA Maximum current consumption 0 5 A See also Figure 12...

Страница 39: ...s complete The display might differ depending on the settings used for the test Figure 133 The display above shows a 6 column graph Figure 13 Each frequency DPOAEs or frequency band TEOAEs is indicate...

Страница 40: ...represent a pass a yellow bar is a non Pass at the frequency band NOTE Diagnostic protocols can display green or purple bars Green is displayed when a PASS criterion is set in the device For more info...

Страница 41: ...re 14 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 if the clock is set correctly this time and date will be correct 3 The test n...

Страница 42: ...and date will be correct 3 The test number if operating in Save 250 mode e g 001 4 The protocol selected e g TE 32s 5 The averaging time used for this test e g 10 sec avg 6 Instrument Probe serial nu...

Страница 43: ...in SNR 4 9 dB The printout values are rounded up to the nearest integer and are shown as TE 5 NF 0 and SNR 5 This can result in what appears to be an error with regard to the pass criterion If the pas...

Страница 44: ...ess SETUP at the protocol selection Display Display 2 page 19 The current date and time presently set in the unit will be shown Display 13 If the time and date are correct press the UP key to escape b...

Страница 45: ...The ERO SCAN unit can be paired with only one device at any time To establish Bluetooth pairing turn on the device that will be paired with the ERO SCAN unit e g thermal printer Then select DISCOVER t...

Страница 46: ...ing Test Results The Test Results Clear menu Display 19 allows the user to clear the test results stored in the unit without printing them Select the LEFT or RIGHT arrow key to clear the results and s...

Страница 47: ...starting with test number 1 When patient names are used patient names are uploaded from the ERO SCAN Database Software to the ERO SCAN unit the patient names are displayed on the ERO SCAN Unit in the...

Страница 48: ...st Pass To change the mode to Minimum Amplitude setting press the LEFT or RIGHT arrow keys to make a selection Once you have made your selection press NEXT The minimum DP amplitude when ON is 5 dB SPL...

Страница 49: ...is shown Press NEXT to exit this menu 17 9 Reset to Default The Reset to Default menu Display 27 will return all instrument settings and protocol settings to their original factory defaults Select the...

Страница 50: ...memory so the settings will be retained even when the battery is discharged temporarily 18 1 Instructions for Customizing a Test Protocol To enter the DPOAE Menu 1 Press CHANGE at the main menu Displa...

Страница 51: ...s 0 5 sec 1 0 sec 2 0 sec or 4 0 sec Press the CHANGE keys to select an option and the NEXT key to exit Display 29 NOTE Longer averaging times help to reduce the noise floor which can improve the like...

Страница 52: ...only 4 frequencies are being tested would result in every test being labeled as a REFER NOTE To disable the PASS REFER indication set the number of frequencies for pass to 0 NOTE Diagnostic protocols...

Страница 53: ...so the settings will be retained even when changing the batteries 19 1 Instructions for Customizing a Test Protocol To enter the TEOAE Menu 1 Press CHANGE at the main menu Display 1 page 19 2 Using t...

Страница 54: ...onds The instrument will automatically stop the test when the pass criterion is met prior to the averaging time Press the CHANGE keys to select an option and the NEXT key to exit Display 34 19 3 Setti...

Страница 55: ...to indicate a PASS Press the CHANGE keys to select an option and the NEXT key to exit Display 36 NOTE Diagnostic protocols display the SNR graph with purple bars Once the Number of Frequencies for PAS...

Страница 56: ...is appropriate for this type of instrument This may not conform to the infection control guidelines of the user s facility The disinfection materials and procedures applied in the users facility may b...

Страница 57: ...IEC and UL 60601 1 20 3 Probe Tube Replacement 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...

Страница 58: ...t in your own ear with the proper eartip for testing yourself If the test will not start or if the AutoStart tones sound unusual replace the probe tube Contact MAICO for service if the problem persist...

Страница 59: ...blish Bluetooth pairing Device Not Responding The printer is not responding to queries from the instrument Check printer status Awaken printer from sleep mode Charge printer battery if necessary Due f...

Страница 60: ...ruption in testing Memory Full The maximum saved test limit is reached The user will need to clear the memory before any additional tests can be performed Power Low The battery charge level is too low...

Страница 61: ...SPL at 1 kHz 1 Hz bandwidth Dimensions and Weight Length 1 0 meter 40 in Weight 28 g 1 00 oz Connector HDMI INSTRUMENT SPECIFICATIONS Power Supply Lithium Ion rechargeable Battery Life 1000 tests per...

Страница 62: ...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 C to 35 C 59 F to 95 F Oper...

Страница 63: ...Operating Instruction ERO SCAN Screening and Diagnostic Version operating_instructions_8106556 6_EROSCAN_e_15a 56 8106556 5 02 15 Appendix A Flowcharts A 1 Test Operation Flowchart...

Страница 64: ...on ERO SCAN Screening and Diagnostic Version operating_instructions_8106556 6_EROSCAN_e_15a 57 8106556 5 02 15 A 2 Setup Menu Flowchart NOTE DPOAE Menu and TEOAE Menu are not accessible in the ERO SCA...

Страница 65: ...main estimates of the actual L1 L2 distortion DP and noise floor NF are obtained via the discrete Fourier Transform with a bin resolution of approximately 31 Hz The NF estimate is obtained by averagin...

Страница 66: ...lly when no emission is actually present If a test is performed with the instrument s probe placed in a test cavity it can be shown theoretically that the SNR will be greater than 6 dB approximately 7...

Страница 67: ...ncies drops the probability of passing an ear with significant hearing loss to 1 or less NOTE By the binomial distribution two of three frequencies at 8 4 dB or three of six frequencies at 7 dB should...

Страница 68: ...ed for DPOAEs Without that difference the numerical SNR value for a PASS with the two methods would be quite similar The ERO SCAN uses a novel noise rejection algorithm patent pending that permits acc...

Страница 69: ...62 8106556 5 02 15 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...

Страница 70: ...5 6 6 3 7 1 8 65 55 4 sec 6 dB 0 DP 1 5 12 12 1 5 2 3 4 5 6 7 8 9 10 11 12 65 55 4 sec 6 dB 0 Diagnostic version also includes DP 4s screening protocol TEOAE Protocols Name of Freq Bands Freq center b...

Страница 71: ...ng sure the system complies with the IEC 60601 1 2 standard Electromagnetic Compatibility Although the instrument fulfills the relevant EMC requirements precautions should be taken to avoid unnecessar...

Страница 72: ...is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the ERO SCAN can help prevent electromagnetic interferences by maint...

Страница 73: ...hospital or residential environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial hospi...

Страница 74: ...ended separation distance in meters m Field Strengthens from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b...

Страница 75: ...perating_instructions_8106556 6_EROSCAN_e_15a 68 8106556 5 02 15 Specifications are subject to change without notice MAICO Diagnostic GmbH Salzufer 13 14 10587 Berlin Germany Tel 49 30 70 71 46 50 Fax...

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