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Operation Manual

ERO•SCAN

8106556 Rev. 11

13//08/2020

6.4 Electrical Safety, EMC and Associated Standards

•

IEC 60601-1:2005+A1:2012 Medical Electrical Equipment, Part 1 General

Requirements for basic safety and essential performance

•

ANSI/AAMI ES60601-1:2005/(R)2012 Medical Electrical Equipment, Part 1

General Requirements

•

CAN/CSA-C22.2 No. 60601-1: 2014 Medical Electrical Equipment, Part 1

General Requirements for Safety Electrical Equipment for Laboratory Use

•

IEC/EN 60601-1-2:2014 Medical Electrical Equipment, Part 1 -

Electromagnetic Compatibility - Requirements and Tests

•

Essential Requirements of the current European Union Medical Device

Directive 93/42/EEC

•

2011/65/EU of 8 June 2011 on the restriction of the use of certain hazardous

substances in electrical and electronic equipment (RoHS)

•

Directive 2002/96/EC of the European Parliament and of the Council of

27 January 2003 on waste electrical and electronic equipment (WEEE)

Содержание ERO SCAN

Страница 1: ...Operation Manual ERO SCAN Screening and Diagnostic Version ...

Страница 2: ......

Страница 3: ... 8 Battery Safety 13 3 Warranty Maintenance and After Sales Service 14 3 1 Warranty 14 3 2 Maintenance 14 3 3 Cleaning and Disinfection Recommendations 15 3 4 Disposables Eartips 16 3 5 Disposables Probe Tubes 17 3 6 Troubleshooting 18 3 7 Recycling Disposal 22 4 Unpacking and Hardware Orientation 23 4 1 Unpacking the System 23 4 2 ERO SCAN Hardware and Components 25 4 3 Handling the Micro Probe 2...

Страница 4: ...4 5 8 Interpreting Test Results 40 5 9 Managing Test Results 44 5 10 Settings 47 6 Technical Data 59 6 1 ERO SCAN Hardware 59 6 2 Pin Assignment 64 6 3 Electromagnetic Compatibility 65 6 4 Electrical Safety EMC and Associated Standards 68 6 5 Configurations and Test Protocols 69 6 6 Flowcharts 70 ...

Страница 5: ...in any form or by any means without the prior written permission of MAICO The information in this publication is proprietary to MAICO Compliance MAICO Diagnostics is an ISO 13485 certified corporation Caution for USA Federal Law restricts this device to sale by or on the order of a licensed medical professional Trademark Notice ERO SCAN is a U S registered trademark of Etymotic Research Inc HearSI...

Страница 6: ...ent The OAEs are generated by a series of clicks that are directed into the ear canal Otoacoustic emissions are low level audio frequency sounds that are produced by the cochlea as part of the normal hearing process Available evidence suggests that otoacoustic emissions are generated by the cochlea s outer hair cells and that the presence of OAEs is an indication that the outer hair cells are viab...

Страница 7: ...ener TEOAE ERO SCAN Screener DPOAE TEOAE 2 DP and 2 TE protocols with fixparameters ERO SCAN Diagnostic DPOAE ERO SCAN Diagnostic TEOAE ERO SCAN Diagnostic DPOAE TEOAE 5 DP and 3 TE protocols 4 DPOAE and 2 TEOAE are customizable 1 4 3 Printing Options Printing test results from the ERO SCAN is accomplished in a variety of ways Print directly from ERO SCAN using the optional wireless label printer ...

Страница 8: ...nes presented in sequence to screen patients for cochlear hearing loss The emissions are clearly related to the stimulus and therefore can be measured via a sensitive microphone placed in the patient s ear canal 1 5 4 Sensitivity and Specificity Sensitivity and specificity of this type of device are based on the test characteristics defined by the user and may vary depending on environmental and o...

Страница 9: ...irety prior to use of the ERO SCAN device on a patient READ THIS ENTIRE OPERATION MANUAL BEFORE ATTEMPTING TO USE THIS SYSTEM Use this device only as described in this operation manual All images and screenshots are only examples and may differ in appearance from the actual device settings In this manual the following two labels identify potentially dangerous or destructive conditions and procedur...

Страница 10: ...tive product should not be used Make sure all connections to external accessories are snug and secured properly 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 NOTE Customer responsibility includes proper maintenance and cleaning of the device Section 3 2 M...

Страница 11: ...detailed information Return to authorized representative special disposal required Reference number Medical Device Global Trade Item Number Patient applied part type B according to IEC 60601 1 Refer to operation manual mandatory Keep away from rain Transport and storage temperature range Transport and storage humidity limitations Transport and storage atmospheric pressure limitations Voltage trans...

Страница 12: ...f accessories transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation The list of accessories transducers and cables can be found in Section 6 3 Electromagnetic Compatibility Do not immerse the device in any fluids ...

Страница 13: ...not complying with the leakage current requirements in IEC 60601 1 shall be kept outside the patient environment i e at least 1 5 m from the patient support or shall be supplied via a separation transformer to reduce the leakage currents Any person who connects external equipment to signal input signal output or other connectors has formed a Medical Electrical System and is therefore responsible f...

Страница 14: ...g to qualified personnel 2 7 Electromagnetic Compatibility EMC The device fulfills the relevant EMC requirements Avoid unnecessary exposure to electromagnetic fields e g from mobile phones etc If the device is used adjacent to other equipment it must be observed that no mutual disturbance appears Also refer to EMC consideration in Section 6 3 Electromagnetic Compatibility The ERO SCAN has been ver...

Страница 15: ...he battery by someone other than an authorized representative will not qualify for repair under the product warranty 2 8 2 Battery Capacity The capacity of the battery will degrade over time with repeated charging discharging cycles The need to replace the battery due to diminishing capacity depends on usage patterns To extend battery capacity do not allow the battery to fully discharge To learn h...

Страница 16: ...ry of the device to the original purchaser The device shall only be repaired and serviced by your distributor or by an authorized service center Opening the device case voids the warranty In the event of repair during the guarantee period please enclose evidence of purchase with the device 3 2 Maintenance In order to ensure that the device works properly it has to be checked and calibrated at leas...

Страница 17: ...ith wet disinfection wipes Follow the instructions on the specific disinfection product Wipe before and after each patient After contamination After infectious patients To avoid damage of the device and its accessories please mind the following Do not autoclave or sterilize the device or probes Do not use the device in the presence of fluid that can come into contact with any of the electronic com...

Страница 18: ...not be cleaned If you use the same eartips for different patients you enhance the risk of bacterial cross contamination which can cause serious infections Replace the eartips with unused ones at the end of each patient s examination and discard the used ones IMPORTANT NOTE All disposable supplies included with the ERO SCAN are produced by Sanibel Supply The system has only been tested using dispos...

Страница 19: ...head Figure 3 3 4 3 Removing Eartips Figure 4 In order to remove the eartip grasp the eartip at the base using the eartip removal tool and pull it smoothly straight off the probe tube Figure 4 If you do not have a Removal tool grasp the eartip at the base with your fingers and twist it while pulling off the probe tube Grasping the base of the eartip will prevent the probe tube from being inadverte...

Страница 20: ...be tube will pull out from the probe Discard the probe tube Figure 6 3 5 3 Applying a New Probe Tube Figure 7 Figure 8 1 Place a new tube into the hole on the top of the tool 2 Align the probe with the probe tube Figure 7 3 Push the probe onto the probe tube until the probe contacts the face of the probe tube tool and a snapping sound is heard Figure 8 4 Slide the tool off leaving the tube in plac...

Страница 21: ...be Results are not printed Check the printer status Turn the printer on wake from sleep mode by pressing the large button If the printer does not turn on plug in the power supply to charge the battery Make sure the printer has paper If paper comes out of the printer but nothing is printed on the paper the paper roll may have been inserted the wrong way round Press the large printer button twice ra...

Страница 22: ... port is open Establishing the serial port is handled by the PC and or the software not by the ERO SCAN Wireless Error xxx There is an error condition with the wireless device Check wireless device printer or PC status Attempt to connect to wireless device again Wireless Not Configured Printing has been attempted but no wireless device is paired with the ERO SCAN Pair the ERO SCAN with the wireles...

Страница 23: ...mit Error Overflow error during the calculation of the DFTs for a DP test Repeat the test Restart the device Memory Almost Full Saved tests are within 5 tests of the maximum limit Print or transfer test result to avoid interruption in testing Memory Full The maximum saved test limit is reached Clear the memory before starting a new test Power Low The battery charge level is too low for operation C...

Страница 24: ...ticle 9 of DIRECTIVE 2002 96 EC on waste electrical and electronic equipment WEEE MAICO has changed their sales policy To avoid additional distribution costs we assign the responsibility for the proper collection and treatment according to legal regulations to our customers Non European countries Outside the European Union local regulations should be followed when disposing of the product after it...

Страница 25: ... immediately to report the shortage If any component appears to be damaged in shipment contact your distributor immediately to report it Do not attempt to use any component or device that appears to be damaged Reporting Imperfections Notify the carrier immediately if any mechanical damage is noted This will ensure that a proper claim is made Save all packaging material so the claim adjuster can in...

Страница 26: ... Charging the Lithium Ion Battery UES12LCP 050160SPA Micro Probe Eartip Removal Tool Probe Tube Removal Tool PC Database Software with Operation Manual Printer Kit incl Power Supply for Charging Printer UE15WCP1 120125SPA and Thermal Printer Paper Micro USB Cable for PC Communication Carrying Case Operation Manual Quick Guide Applied parts according to IEC 60601 1 Disposables supplied NOTE MAICO s...

Страница 27: ...RO SCAN device 2 Micro Probe 3 single use eartips for single use only 4 probe tubes for single use only 5 Micro USB cable 6 Thermal Printer Figure 9 shows the ERO SCAN device Figure 9 Control Panel with Membrane Type Push Buttons Charge Status Indicator Display Organic Light Emitting Diode OLED Test Status Indicators Light Emitting Diode LED Probe Connector Micro USB Connector ...

Страница 28: ...gns with the device control panel NOTE 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 If damage is observed contact MAICO Diagnostics 4 4 Battery Charging Figure 12 The ERO SCAN is powered by an integrated rechargeable lithium ion battery 1700 mAh providing 15 hours 1000 tests minimum of operation...

Страница 29: ...arging is needed Slow blinking Charging is in progress Fast blinking Indicates an error Contact your local representative or MAICO for help Steady Battery is fully charged 4 5 Establishing a PC Connection To transfer data to a PC establishing a PC connection via USB is required If the ERO SCAN is used with office equipment that is not a medical device itself see Table 3 PC Connection 1 make sure t...

Страница 30: ...n 4 Medical device Laptop battery driven 4 6 Using the MPT IIThermal Printer 4 6 1 Powering the Thermal Printer Battery pack insertion Figure 15 Insert battery as shown Figure 15 Charging the battery Figure 16 The thermal printer is powered by a Lithium ion battery In order to charge the battery you must insert the plug of the power supply into the laterally placed socket and plug the power supply...

Страница 31: ...harging Light Indicators Table 7 MPT II Charging Light Indicator Green LED indicator Blue LED indicator Status Sound Note Off Fast flash Charging Power On Off On Charging Power Off Off Slow flash Battery nearly discharged Off On Charging completed Power On Off Off Charging completed Power Off On Off Power ON battery powered Slow flash Slow flash Out of paper Beep Slow flash Off Sleep mode Self tes...

Страница 32: ...ing the MPT II Thermal Printer to ERO SCAN The connection of the ERO SCAN and the printer is made via wireless pairing Section 5 10 2 2 Wireless Device Pairing NOTE It ispossible to pairfourdevices with one printer Do not have severalprinterspowered on and within range while searching 4 7 Storage When the ERO SCAN is not in use store it in the carry case or in a location where it will be safe from...

Страница 33: ...up The ERO SCAN should be operated in a quiet room so that the audiometric examinations are not influenced by outside noises Ambient sound pressure levels in an audiometric test room shall not exceed the values specified in the norm ISO 8253 1 or ANSI S3 1 5 1 3 Noise Sources When the noise level exceeds the noise rejection limit of the device the orange NOISE light will appear It is common for th...

Страница 34: ...eds a nominal threshold of 55 dB SPL Test duration will be prolonged Section 5 1 3 Noise Sources Also used to indicate some error conditions and when the outcome of test is Refer Noisy or No Seal TEST Orange The selected test is being performed This indicator light remains lit throughout the test procedure READY Green The device is ready to perform a test CHARGE Blue Shows the battery recharging f...

Страница 35: ...e Device Figure 23 To turn on the ERO SCAN press the DOWN key located below the display Figure 22 The yellow light TEST will appear briefly just above the display screen The green light READY will remain on indicating the device is ready for use The Flash Screen Figure 23 appears briefly It shows the device version Screening Version SCR Screener Plus SC Standard STD or Combo CMB the software versi...

Страница 36: ...down Time 5 6 Main Menu Figure 25 gives explanation to the Main Menu Figure 25 5 7 Testing Procedure 5 7 1 Calibration and Test The ERO SCAN automatically performs a calibration prior to the start of each test During calibration test signals are presented to the ear canal to calibrate the levels of the frequencies to be tested After calibration the test phase starts automatically NOTE The testing ...

Страница 37: ...d TE Figure 27 Graph Value view The Graph Value view shows the absolute emission and noise levels for each DP test frequency or TE test band Figure 27 Section 5 10 2 8 Graph Style Settings 5 7 2 Selecting the Test Protocol Figure 28 The currently selected protocol is shown on the Main Menu To select another protocol press CHANGE to proceed to the next screen CHANGE to select another protocol Figur...

Страница 38: ...he baby in a blanket with the arms wrapped inside is recommended This will calm the baby and keep the baby from interfering with the screening device components Otoscopic examination 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 exc...

Страница 39: ...uperficial Release the earlobe You should not hold the OAE probe during the measurement since this can cause acoustic noise Figure 9 5 7 4 Starting a Test Probe Check IMPORTANT NOTE To test children with Pressure Equalizer PE tubes the Probe Check needs to be omitted Proceed as follows to disable the AutoStart function Hold down the LEFT or RIGHT arrow keys for 3 seconds until the green LED READY ...

Страница 40: ... during the test procedure If the probe check is not successful try the following 1 Select an eartip that fits the ear canal of the patient better 2 Try once more to place the probe see description above If you can still not start the test proceed as follows Turn off the device Change the probe tube Make sure that the probe connector is seated properly in the socket Try again to start a test 5 7 5...

Страница 41: ... 5 1 3 Noise Sources No Seal A seal was not maintained throughout the test Try another eartip size and retest FIT ERR Probe placement in the ear canal is inadequate to produce target stimulus intensities Try to achieve a better probe fit and retest NOTE The results of the test are automatically saved in the memory as soon as the test is complete The results are saved even if the device turns off o...

Страница 42: ... 5 10 2 8 Graph Style SNR Graph View Figure 38 Figure 38 shows the SNR bar graph view You see 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 The height of each column represents the SNR measured in dB If you have selected a protocol with a Pass criterion you see a horizon...

Страница 43: ...onal display features include the grey shaded area representing the Boys Town Norms The green line represents the minimum amplitude setting has been turned on Both of these settings are optional to be displayed and are independent from one another These settings are defaulted off 5 8 2 Interpreting Printed Results Results from the ERO SCAN can be printed in multiple ways It is up to the examiner t...

Страница 44: ...g 001 5 The protocol selected e g DP 2 0 5 0 6 The averaging time used for this test e g 4 sec avg 7 Device Probe serial number SN 8 The ear selected Right or Left 9 A PASS REFER indication if there is a criterion set for the selected protocol 10 Graphic display of results 11 Printout notification when Minimum Amplitude is On e g MIN 12 The f2 frequency in kHz e g 2 0 3 0 4 0 5 0 13 SPL of present...

Страница 45: ...correct 4 The test number if operating in Save 500 mode e g 001 5 The protocol selected e g TE 64s 6 The test time used to complete the test e g 4 sec avg 7 Device Probe serial number SN 8 The ear selected Right or Left 9 A PASS REFER indication if there is a criterion set for the selected protocol 10 Graphic display of results SNR or Value graph 11 Printout notification when Minimum Amplitude is ...

Страница 46: ...pletion of testing to avoid potential loss of data How the test results are saved depends on the save mode Section 5 10 2 5 Save Mode Storing Test Results Choose between Save L R mode only the most recent test results for the left and right ear are saved for printing and or transfer to a PC Save 500 mode The last 500 test results are saved for printing and or transfer to a PC If patient data are t...

Страница 47: ...lts 5 9 4 Transferring Test Results to a PC It is possible to transfer data from the ERO SCAN to the following PC software MAICO Sessions Standalone MAICO Sessions with OtoAccess Database MAICO Sessions with Noah Database MAICO Sessions with your existing Practice Management Software via BDT GDT interface HearSIMTM Software with OtoAccess Database only results of the test protocols TE 32s TE 64s D...

Страница 48: ...reen shows PLEASE WAIT Figure 44 CANCEL to cancel the printing process if wanted 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 Figure 44 5 9 ...

Страница 49: ... it after tests are saved will not change the date on the printout i e whatever date was previously in memory will be the date on the printout To enter the clock menu proceed as follows CHANGE to enter the Protocol Selection Menu SETUP to enter the Clock menu Figure 45 The Clock menu shows the currently set date and time Figure 45 Press CHANGE briefly to proceed to the next screen NOTE If you pres...

Страница 50: ...hutdown Time Minimum Amplitude Value Save Mode Clock Mode Language Reset to Default Settings Access the General Device Settings Menu CHANGE to access the PROTOCOL menu SETUP to access the CLOCK menu CHANGE hold for 3 s to enter the WIRELESS DEVICE menu Press and hold for 3 s until the green LED READY turns off Figure 20 NOTE It is also possible to set advanced options for the DPOAE and TEOAE tests...

Страница 51: ...est results Figure 49 DISCOVER to search for wireless devices approx 15 s Display shows Please wait and yellow LED TEST flashes CANCEL to cancel discovery if wanted Figure 50 Discovered devices are displayed A compatible thermal printer is displayed with PRT XX XX e g PRT e4 8c Figure 50 CHANGE to select the printer PAIR to pair with the printer Figure 51 If the display shows WIRELESS PAIRED the p...

Страница 52: ...C PAIR to pair with your PC Figure 55 If the display shows WIRELESS PAIRED the pairing process was successful NOTE If wireless pairing is unsuccessful or if any error messages are displayed see Section 3 6 MainMenu to exit the wireless pairing menu 5 10 2 3 Clearing Test Results Figure 56 The TEST RESULTS menu allows the user to clear the test results stored in the device Figure 56 NOTE After prin...

Страница 53: ...00 Tests mode with the ERO SCAN there are two ways of operating When a Software is used to transfer patient names to the device 50 patients can be transferred to the device The ERO SCAN will show the names in an alphabetical order You can cycle through the names using the left and right arrow A patient named Unnamed is always included at the beginning of the ERO SCAN list for instances when a pati...

Страница 54: ...y measured Default MIN VALUE setting is 10 dB SPL CHANGE to select a value between 10 dB SPL to 5 dB SPL or to set it OFF NEXT to proceed to the next screen 5 10 2 7 Clock Mode Figure 61 The CLOCK MODE menu allows the user to change the clock from a 24 hour mode to a 12 hour mode Figure 61 CHANGE to select 12 Hour or 24 Hour NEXT to proceed to the next screen 5 10 2 8 Graph Style Figure 62 The use...

Страница 55: ... for DPOAE testing Figure 64 CHANGE to select REV FREQ ON or REV FREQ OFF NEXT to proceed to the next screen 5 10 2 11 Auto Stop Figure 65 The activated AUTO STOP function stops the DPOAE test automatically as soon as the required number of passed frequencies is reached for time saving reasons Figure 65 CHANGE to select AUTO STOP ON or AUTO STOP OFF NEXT to proceed to the next screen 5 10 2 12 Lan...

Страница 56: ...sonnel usually the administrator If you are not familiar with the use of these variables do not attempt to change the protocols Changes to any of these characteristics may yield test results that differ from those obtained in other test modes IMPORTANT NOTE Any change of the parameters Level SNR for PASS Number of Frequencies for PASS and Minimum Value has an influence on the Sensitivity and Speci...

Страница 57: ...E menu Press and hold for 3 s until the green LED READY turns off NEXT to select a protocol parameter to change CHANGE to change a parameter DONE to save the parameters and exit the TEOAE menu NOTE If you push the DOWN arrow key without holding it for 3 seconds you will scroll through date and time etc rather than accessing the custom menus 5 10 3 2 Advanced Options for DPOAE Testing Selecting the...

Страница 58: ...e an overall PASS REFER for each test Figure 71 CHANGE to select a value between 3 dB and 10 dB NEXT to proceed to the next screen Setting the Number of Frequencies for PASS Figure 72 The user can adjust the number of frequencies that have to fulfill the SNR PASS criterion and optionally the MIN VALUE criterion in order to generate an overall PASS result on the screening measurement If the defined...

Страница 59: ...exit the menu NOTE If you press DONE before saving you lose the settings made 5 10 3 3 Advanced Options for TEOAE Testing Selecting the Averaging Time Figure 75 A longer averaging time increase measurement duration and result quality A shorter averaging time decreases measurement duration and result quality Figure 75 CHANGE to set the averaging time to 4 s 8 s 16 s 32 s or 64 s NEXT to proceed to ...

Страница 60: ... a number between 0 and 6 NEXT to proceed to the next screen Reset Protocol Figure 78 Figure 79 This RESET TO DEFAULT menu allows you to reset the settings of the currently selected protocol to the factory settings Figure 78 NOTE Using this function you only reset the currently selected protocol The device settings and settings of other protocols remain unaffected RESET to proceed to the RESET PRO...

Страница 61: ...cording to the class IIa of the EU medical directive 93 42 EEC 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 STANDARDS Device Safety IEC 60601 1 2012 Internally power T...

Страница 62: ... 176 g 6 2 oz 204 g 7 2 oz with probe Display Display Size 42 7 mm x 33 4 mm 1 7 in x 1 3 in Resolution 160 x 128 Mode of operation Continuous Connectors OAE HDMI Connector for connection to the Micro Probe USB Micro USB Data Interfaces PC connection Micro USB Wireless connection Printing Wireless connection User Feedback Acoustical Integrated speaker Visual Color display and LED User Interface OL...

Страница 63: ... 60 Hz 0 5 A Output 5 0V DC 1 6A MAX Safety IEC 60601 1 Class II DPOAE Stimulus Frequency range 1500 Hz to 12 kHz Frequency accuracy 1 Default frequencies See Section 6 5 Configurations and Test Protocols Nominal frequency F2 F2 F1 Ratio 1 2 Level range 40 dB SPL to 70 dB SPL Level accuracy 1 5 dB Default level L1 L2 65 dB SPL 55 dB SPL with in ear calibration Transducer OAE Probe Recording Maximu...

Страница 64: ... 3 3 5 4 Recording Maximum test time 64 s depends on averaging time of the selected protocol Maximum noise level 55 dB SPL Averaging method Bayesian weighted averaging Display SNR view value graph view Pass criteria SNR criteria Depends on protocol Response criteria Depends on protocol Freq bands Depends on protocol TRANSDUCER OAE Probe Microphone System Noise 20 dB SPL at 2 kHz 1 Hz bandwidth 13 ...

Страница 65: ... 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 81 Figure 81 Size 02 mm x 75 mm x 45 mm 4 02 in x 2 95 in x 1 77 in Weight Weight 205 g including battery without paper Environment Conditions Operational temperature range 10 C to 50 C 14 F to 122 F Operational humidity range 20 t...

Страница 66: ...D 5 Ground PROBE CONNECTOR TYPE A RECEPTACLE HDMI FEMALE Pin 1 Rcvr Pin 11 Unused Pin 2 Rcvr Shield Pin 12 Unused Pin 3 Rcvr Pin 13 Unused Pin 4 Reserved Pin 14 Reserved Pin 5 Shield Pin 15 Comm Power Pin 6 Reserved Pin 16 Comm Data Pin 7 Mic Power Pin 17 Ground Pin 8 Mic Shield Pin 18 3 3V Pin 9 Mic Out Pin 19 Ground Pin 10 Mic Power ...

Страница 67: ...n this instruction No further steps required Electromagnetic Compatibility EMC Portable and mobile RF communications equipment can affect the ERO SCAN Install and operate the ERO SCAN according to the EMC information presented in this chapter The ERO SCAN has been tested for EMC emissions and immunity as a standalone ERO SCAN Do not use the ERO SCAN adjacent to or stacked with other electronic equ...

Страница 68: ...c 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 Electromagnetic environment guidance Electrostatic Discharge ESD IEC 61000 4 2 8 kV contact 15 kV air 8 kV contact 15 kV air Floors should be wood concrete or cerami...

Страница 69: ... symbol NOTE1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and...

Страница 70: ...ectrical Equipment Part 1 General Requirements for Safety Electrical Equipment for Laboratory Use IEC EN 60601 1 2 2014 Medical Electrical Equipment Part 1 Electromagnetic Compatibility Requirements and Tests Essential Requirements of the current European Union Medical Device Directive 93 42 EEC 2011 65 EU of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical a...

Страница 71: ... 8 65 55 4 s 6 dB 0 DP 1 5 12 12 1 5 2 3 4 5 6 7 8 9 10 11 12 65 55 4 s 6 dB 0 TEOAE Protocols DEVICE VERSION NAME NUMBER OF FREQ F2 FREQ KHZ AVERAGING TIME PER FREQ PASS SNR NUMBER OF FREQ FOR PASS Screen ing TE 64s 6 1 5 2 2 5 3 3 5 4 64 s 4 dB 3 TE 32s 6 1 5 2 2 5 3 3 5 4 32 s 4 dB 3 Diag nostic TE 64s 6 1 5 2 2 5 3 3 5 4 64 s 4 dB 3 TE1 5 4 0 6 1 5 2 2 5 3 3 5 4 64 s 4 dB 3 TE0 7 4 0 6 0 7 1 1...

Страница 72: ...Operation Manual ERO SCAN 8106556 Rev 11 70 13 08 2020 6 6 Flowcharts 6 6 1 Test Operation Flowchart ...

Страница 73: ...Operation Manual ERO SCAN 1 8106556 Rev 11 71 13 08 2020 6 6 2 Setup Menu Flowchart NOTE DPOAE TEOAE Menu are only accessible in the ERO SCAN Diagnostic version ...

Страница 74: ...pecifications 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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