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ERO•SCAN® Operating Instruction

1. HO 43 E ae Dt m 43 19 Advanced Options for TEOAE Testing e eere eee 44 19 1 Instructions for Customizing a Test PrOtOCOl cccccceseccccesseccceesececeeeceeceeecceeeesececsuseceseuneceeseeeeeetas 44 19 2 Selecting the Averaging TIT i mis cinsan y l nn ette tuwh i30 makinan kah kun Ak ista retibus ba ei Miser esi e ARM 45 19 3 SebInse The PASS SNR ooo gt gt gt hnnrnrnrnsnnb mmmrmmmm__ 45 19 4 Setting the Number of Frequencies for PASS kek keke k k KK KK KRA 46 195 xe PRU TM 46 196 Save are MONET TT err s 46 20 Cleaning and Maintenance 4 xxckkkkkkkkkkkkkkkk kaka kk kk KAK KA A KWA AKAR A WAA 47 20 1 Cleaning and DISINFECTION si ks 4ayy nikanin n Kayay ben s enne nnns nnns sarta nns nnne W 47 MAWA ANGIE SINAN E RT mme 48 20 3 Probe Tube Replace meli ii sinne lenekala eee eka n k Case toute lade casn k n n SOUPE k n k ne bav e h ke 48 TT 8106286 Rev A m ERO SCAN Operating Instruction MAICO A VOU NSS INGO UNO EO E EE E pn mm 49 22 SOCCINICACION S courantes v IS MENISKINSSFSUNNSEDFFAS MU TENDS NSRI SEU NEU UNE an 52 Appendix A PIOWCTA N u cuda p RIDERSMI ERE EEA NONEM EM EE 54 Appendix B Test Sequence MhA xx xxu kkkkkkkk kaka kaka kk kk k CE INIM DNUS WAA E 56 Appendix C Pass Refer Criteria eeeeee eese e eene
2. 11ceeeeeee eese eeee eene KAK A KK nnn nnn nnn 10 B aras elan el Nr cl E kv 12 8 1 How Does the ERO SCAN Device Work cccccssssssesesesesesesesesesesesescscsvsvsvevevevavavavavavasacacacacacaceseseees 12 8 2 How are the Results Stored and Reported eessessssssseeseseeeee eene nennen essen nnns 13 8 3 i acid and es sre Ly DD EB B Ba m ne enero ne eee ee 13 9 SEUD 14 9 1 LTA eC MS ES COI EE E id domes O E PETE E EEEE TT 14 9 2 nza EINE eae ene On Oa rd 14 9 3 oe Ni real plea ll yel ae a UONYNNNDDNNNNDEMDMDMIMIMMMMNMVMVMNNENRN NJM MM M LO 15 9 4 PUT UG PUN Te AU OG Sc tere RP 16 8106286 RevA ERO SCAN Operating Instruction MAICO 10 Operating Instructions J K seek eva kk kk kk UU KAKA AA AK KA KAK KA A kK KA KK A EG 17 10 1 Preparing he atlelll Tor Wes CINE n n yen nen D0N nt Sa Pn car nid R s na A NUMEN Me IU N k o p di n dR Dk 17 10 2 I rping On The Inst PUE B DE si ae enn en re o Td eS k bek KA K Se R DEus kane w S Wa eb 17 NNE Eo go a S erz TT Tj j TT np R 17 WA EE da 18 LOS Selecting the Test PIOLtOCO ci si s lena e pt cots Eoi esai ntes E 18 10 6 PROBE Checks BCCI iS 3 TeSt iil ua HIS eC chier AR KA K k SUI KA 19 10 7 Calib at on al I S REESE 20 o MEE US aA EEUU 20 t EI UT oU LA lO ane
3. 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 how to initiate Bluetooth search please refer to your device s user manual NOTE See the chapter Bluetooth Device Pairing for more detailed information Technical specifications Print mode e Thermal line dot print e Printing width 48 mm 1 9 in e Resolution 8 dots mm 203 dots per in dpi e Dots per line 384 dots Thermal paper e Paper width 56mm 1 mm 2 2 in 0 04 in max 40 mm 1 6 in diameter Battery pack e 2 cell Li lon battery pack 7 4 V 1500 mAh Power supply charger e 12 V 1 AUE15WCP1 120125SPA e Maximum current consumption 0 5 A See also Figure 11 UI u Figure 11 Physical properties Size 102 mm x 75 mm x 45 mm 4 02 in x 2 95 in x 1 77 in W x L x H Weight 205 g including battery without paper Environmental specifications Operational temperature range 10 C to 50 C 14 F to 122 F Operational humidity range 20 to 85 96 Storage temperature range 20 C to 70 C 4 F to 158 F 8106286 RevA M A ERO SCAN Operating Instruction MAICO 13 Interpreting Results 13 1 Understanding the Display The display on the EROeSCAN 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 r
4. Problem Instrument does not turn on The test will not start The results will not print Display is frozen and instrument will not respond to button presses Solutions The wDOWN arrow must be pressed for a full second the Yellow TEST LED will illuminate Connect the charger as shown in Figure 2 on page 15 Confirm that the blue Charging LED is illuminating in a slow blink pattern Wait at least 10 minutes and then attempt to turn on the instrument Contact MAICO for service if the problem persists Select a different sized eartip Reposition the probe Change the probe tube Verify that the eartip is sealed in the ear canal via feedback from the PROBE CHECK screen Check that the instrument will start 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 persists across several patients 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 Be sure the printer has paper If paper comes out of the printer but there is no text on the paper then the paper is in backwards Press the large printer button twice rapidly to run demo print Contact MAICO for service if the problem persists Press and hold the WDOWN arrow button for 10 seconds to force t
5. normal hearing However a passing result using this instrument is not an indication that the full auditory system is normal Thus a PASS result should not be allowed to override other indications that hearing is not normal A full audiologic evaluation should be administered if concerns about hearing sensitivity persist A REFER test result should not be assumed to be an indicator of a lack of auditory function however it should be followed with full audiologic diagnostic testing 13 8106286 Rev A M A ERO SCAN Operating Instruction MAICO 9 Setup 9 1 Unpacking the System The following is a list of parts shipped with each EROeSCANS system EROeSCAN Instrument Micro Probe Box of Single Use Eartips Package of Probe Tubes Micro USB Power Supply for Charging the Lithium Ion Battery Operating Instructions PC Database Software with Manual Micro B to A USB Cable for PC Communication Charging Protective Carrying Case Optional e Printer e Printer Power Supply for Charging Printer e Thermal Printer Paper Roll If any of these parts are missing contact your special equipment distributor or MAICO Diagnostics at 888 941 4201 We recommend that you save the shipping box and packing materials in case you need to store or ship the system 9 2 Battery Charging The EROeSCANS instrument is powered by an integrated rechargeable lithium ion battery 1800 mAh providing 20 hours 1000 tests minimum of operation between full c
6. the PASS SNR must be set This number refers to the number of decibels that the DPOAE signal must be above the noise to be considered a PASS at that frequency The limits for the PASS SNR are 3 dB to 10 dB Pressing the LEFT or RIGHT arrow keys will increase or decrease the requirement This requirement is used in combination with the number of frequencies discussed below to determine an overall PASS REFER for each test Press the CHANGE keys to select an option and the YNEXT key to exit Display 30 42 8106286 Rev A M MAICO ERO SCAN Operating Instruction 18 5 Setting the Number of Frequencies for PASS O FREQS FOR PASS lt CHANGE gt w NEXT Display 31 18 6 Reset Protocol RESET PROTOCOL RESET 22 w NEXT Display 32 18 7 Save Protocol SAVE PROTOCOL SAVE d w DONE Display 33 The number of frequencies required for determining a PASS can be set from O to 12 If the setting is on O then no indication of PASS REFER will be made This setting is used in conjunction with the PASS SNR Display 30 page 42 to set the criteria for the overall test PASS REFER indication For example if the PASS SNR is set to 5 dB and the number of frequencies for PASS is set to 3 then the test must contain at least 3 frequencies where the emission is at least 5 dB above the noise to indicate a PASS The number of frequencies for PASS should also be based on the number of frequencies
7. 2 5 L O Lu 0 u 2 0 d 1 596 THREE IN 1000 PROBABILITY OF 4 dB OR GREATER SNR IN 3 OF 6 FREQUENCIES 1 096 0 596 5 of 6 FREQ 0 096 dB SNR Diagram 2 60 8106286 Rev A M A ERO SCAN Operating Instruction MAICO Appendix D Configurations and Test Protocols DPOAE Protocols BN tt are ous lina Un Name Freq Freq kHz L1 L2 g Time SNR o Pass Screening DP4s 4 2 3 4 5 EREN DP2 4 2 3 4 5 6555 2se 6dB 3 4 5 65 55 4sec 6dB 3 Bal TU Lan 2U a an 2 0 5 0 ESSE poseen Sn o e e 1 5 6 0 65 55 4sec 6dB O Diagnostic version also includes DP 4s screening protocol TEQAE Protocols cs tm Ke RR EA am WER Name Bands bands kHz Time max Pass SNR for Test Pass Screening TE 64s 1 5 2 2 5 3 64 4 dB uu TE pane 4 dB T2 4 40 A 4 0 8 4 Diagnostic version also includes TE 64s screening protocol Customizable fields L1 L2 DP 40 to 70 dB SPL Average time DP 0 5 1 0 2 0 or 4 0 sec TE 4 8 16 32 or 64 sec Pass SNR DP and TE 3 dB to 10 dB Passing Freq for Test Pass DP and TE 1 to 12 61 8106286 Rev A M A ERO SCAN Operating Instruction MAICO Appendix E EMC Compatibility Portable and Mobile RF communications equipment can affect the EROeSCAN Install and operate the ERO eSCAN according to the EMC information presented on this page and the next 4 pages The EROeSC
8. DPOAEs Without that difference the numerical SNR value for a PASS with the two methods would be quite similar The EROeSCAN uses a novel noise rejection algorithm patent pending that permits accurate DPOAE and TEOAE measurements in background noise and babble as high as 55 dB SPL to 65 dB SPL A weighted Briefly explained use of available memory in the EROeSCAN processor permits a post hoc statistical analysis that identifies those samples whose retention would improve the overall accuracy Those samples are included in the final analysis the noisier samples are rejected The improved operation in noise with the new algorithm was so substantial that we conducted a complete replica of our original validation tests in fully impaired ear cavities and were able to verify that no increase in false negatives false passes was introduced Under no test conditions was any such degradation uncovered 59 8106286 Rev A M A ERO SCAN Operating Instruction MAICO 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 PROBABILITY OF MISSING MOD SEVERE HL N SNR INCIDENCE BY PASS CRITERIA METAL CAVITY 4 596 4 096 1 of 6 FREQ 3 5 w 2 of 6 FREQ z 3 0 3 of 6 FREQ 5 4 of 6 FREQ Z
9. Instruction MAICO 5 Safety Precautions The following safety precautions must be observed at all times General safety precautions must be followed when operating electrical equipment Failure to observe these precautions could result in damage to the equipment and injury to the operator or patient The employer should instruct each employee in the recognition and avoidance of unsafe conditions and the regulations applicable to his or her work environment to control or eliminate any hazards or other exposure to illness or injury It is understood that safety rules within individual organizations vary If a conflict exists between the material contained in this manual and the rules of the organization using this instrument the more stringent rules should take precedence The EROeSCANS is intended 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 Cautions General CAUTION If the system is not functioning properly do not operate it until all JX 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 Never insert the probe tube into the ear canal without affixing an eartip The eartips are disposable and for single patient use only
10. Power Frequency 50 60 Hz IEC 61000 4 8 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode lt 5 UT gt 95 96 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 96 UT 29596 dip in UT for 5 sec 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode b 96 UT gt 95 96 dip in UT for 0 5 cycle 40 96 UT 6096 dip in UT for 5 cycles 70 96 UT 3096 dip in UT for 25 cycles 5 UT gt 95 dip in UT for 5 sec Note UT is the a c mains voltage prior to application of the test level 64 Electromagnetic Environment Guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be greater than 3096 Mains power quality should be that of a typical commercial hospital or residential environment Mains power quality should be that of a typical commercial hospital or residential environment Mains power quality should be that of a typical commercial hospital or residential environment If the user of the EROeSCAN requires continued operation during power mains interruptions it is recommended that the ERO SCAN be powered from an uninterrupted power supply Power frequency magnetic fields
11. and the yellow TEST LED will flash Discovery can be canceled by pressing the ACANCEL button When discovery is complete all discovered devices will be shown in the order in which they were found Display 17 A compatible thermal printer will appear as PRT e g PRT 54 81 and other devices will be shown by their name which can vary depending on the device Use the CHANGE buttons to select the desired device and then use the wPAIR button to pair the EROeSCAN to the selected device Pairing will be confirmed Display 18 The pairing process is complete Select WMain Menu to exit the Bluetooth pairing menu NOTE See the 7roubleshooting section on page 49 if Bluetooth pairing is unsuccessful or if any error messages are displayed 36 8106286 Rev A M A ERO SCAN Operating Instruction MAICO 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 15 Bluetooth Settings Options COM Ports Hardware Share PIM Interface Discovery Allow Bluetooth devices to find this PC A Bluetooth devices will see the name of this PC Figure 15 Bluetooth Settings Select the Bluetooth pairing Menu Display 16 page 36 and press lt DISCOVER gt to start the pairing process When the computer
12. being tested Setting the number of frequencies for PASS to 5 when 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 O NOTE Diagnostic protocols display the SNR graph with purple bars Once the Number of Frequencies for PASS is set above zero green bars display to identify this setting Press the CHANGE keys to select an option and the YNEXT key to exit Display 31 Selecting the RESET arrow key in the Reset Protocol menu Display 32 will return the selected protocol settings to their original factory settings Press the WNEXT key to exit NOTE This does not affect the instrument settings or the settings of any other protocol Once all of the settings have been selected for the protocol these settings can be saved by selecting the SAVE keys Display 33 Press the WDONE key to exit Selection of the WDONE before saving will not save the selection made to the protocol 43 8106286 Rev A M A ERO SCAN Operating Instruction MAICO 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 Changes to the protoc
13. 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 Place the patient in a position that will allow easy access to the ear canal Use the shirt clip on the remote probe to secure the probe to clothing or bedding The patient should remain still and quiet while the test is being performed 10 2 Turning On the Instrument To turn on the EROeSCAN instrument press the WDOWN key located below the instrument s display screen see Figure 7 The yellow TEST light will appear briefly just above the display screen The green READY light will remain on indicating 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 version serial number for example ME1234567 and a recalibration date If the battery is sufficiently charged the EROeSCAN will power on and automatically check the date and time If there are no date time errors detected the Main Menu Display 1 page 18 will appear on the display If this is the first time the EROeSCAN is being used or if you wish to change the date or time see the section Clock Settings on pa
14. defects in material and workmanship and when properly used will perform in accordance with applicable specifications If this instrument does not meet these criteria within one year of original shipment it will be repaired or at our option replaced at no charge when returned to our service facility 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 THIS WARRANTY IS IN LIEU OF ALL 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 Test System contact your Special Equipment Distributor or contact MAICO Diagnostics by phone at 888 941 4201 or by fax at 952 903 4100 2 1 Intended Use The ERO SCAN OAE Test Instrument is indicated for testing of cochlear function in infants children and adults by measuring otoacoustic emissions OAEs This instrument is suitable for use in all settings including hospitals schools physician s offices and audiologist practices Factory defined protocols allow for simple screening measurements and user customizable protocols allow for diagnostic evaluations The EROeSCANS is intended to be used by hearing healthcare professionals i e ENT doctors audiologist
15. is seen on the device select WPAIR While the device is pairing to the computer a notification will display on your computer Add a device Select this notification on your computer and enter PIN 1234 Once paired the instrument will show Display 18 on page 36 The first time the EROeSCAN Database Manager Software is opened select Detect Com Port to finalize the EROeSCAN connection 17 2 Clearing 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 lt LEFT or RIGHT gt arrow key to clear the results and select lt Yes or RESULTS No to verify clearing or to cancel To advance to the next menu lt CLEAR gt without clearing the results press WNEXT w NEXT 2 Veal NOTE Following printing or data transfer to the PC software all tests saved in memory are marked for deletion and will be permanently deleted when a new test is started It is not necessary to manually clear the results using this menu Display 19 17 3 Auto Shutdown Time The Power Off menu Display 20 refers to the Auto Shutdown POWER OFF time which controls how long the EROeSCAN instrument waits before shutting itself off after a period of inactivity It is not necessary to manually turn off the EROeSCANS unit The Automatic Shutdown feature Is designed to prolong the battery lite of the instrument when it is not in use By default the instrument 1
16. loss is roughly 2 per 1 000 verifying a 99 7 96 accuracy would require testing hundreds of thousands of babies with a given system Thus to demonstrate that only 3 babies out of 1 000 with hearing loss were missed would require follow up testing on 500 000 babies To our knowledge no one has performed such tests to date 58 8106286 Rev A M A ERO SCAN Operating Instruction MAICO PROBABILITY OF MISSING MOD SEVERE HL SNR DISTRIBUTION METAL CAVITY 100 90 ONE IN 100 PROBABILITY OF SNR 5 dB AT 3 OF 4 FREQUENCIES 80m urs BINOMIAL DIST 70 E ka ONE IN TEN 60 PROBABILITY OF SNR gt 7 dB 50 AT ONE FREQUENCY 40 ONE IN 100 PROBABILITY 30 OF SNR gt 7 dB AT a 3 OF 6 FREQUENCIES i BINOMIAL DIST NUMBER OF OCCURRENCES 20 CUM DIST 3 FREQ DISTRIBUTION CUM DIST 1 FREQ i CUM DIST 2 FREQ 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 96 NOTE The SNR limits for transients are lower than the corresponding limits for distortion products primarily because the traditional noise calculation used in TEOAE measurements and in the EROeSCAN instrument gives a 3 dB lower SNR than the calculation used for
17. minute lt CHANGE gt w NEXT Display 20 automatically shuts off after 1 minute has elapsed 37 8106286 Rev A M A ERO SCAN Operating Instruction MAICO 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 wv NEXT 17 4 Save Mode Storing Test Results The EROeSCANS unit automatically stores only the most recent test result for each ear L R Display 21 but has the capacity to store SAVE L R 250 individual tests To change the mode to save up to 250 tests TESTS press the LEFT or RIGHT arrow keys to change the menu to lt CHANGE gt 250 Once you have made your selection press W NEXT w NEXT l There are two options in the Save 250 mode Display 22 Display 21 1 The EROeSCAN will automatically number each test from 1 to 250 2 The EROeSCAN Database Software is used to transfer patient names to the EROeSCAN and the EROeSCAN will SAVE 250 display the names Up to 50 names can be stored in the TESTS device and 250 tests lt CHANGE gt VE NEXT When numbers are used no patient names are uploaded from the ERO SCAN Database Software to the ERO SCAN each test is Display 22 automatically incremented starting with test number 1 When patient names are used patient names are uploaded from the EROeSCAN Database Software to the EROeSCAN unit the patient nam
18. mr ne n y key ban PR e w K es Pe T 21 i Hall NOLE OUE m 22 IO IT Turning OP the BS Pell i Ann nonu ada E atu kerin leye la n K E nt d 22 T Managing Results eee ee el enan ana n be Eco Dua wende nii de ke duwa daa b da 23 kG RR Dn SS E JJ oxx0 wvwnxnx2 23 17 Delene RO UN aues _r_r_r_rerereernrn ee Dn o r _moo_ 24 11 3 Printing to a Thermal Printer nennen nennen kK KK K nennen 24 11 4 Connecting to the PC Database SOTtWALFe ici repite i eoo E eru ege EUR b na b UY EN pev Rb EE van 25 12 MPT II SANIBEL Mobile thermal mini printer 26 p ME eue PP MAMA JJJJ m 27 13 Interpreting Results M L kk kk Pu kk CUrxE ERE KAKA KK KK KA A MEM SEU KK A A 30 131 Understanding the Display 3 mi in xeten ken nika bede eyn b Koy i ke N ibd d y Sen bis kek n d 90eyn kinn beb n 30 be NRE PON N Tm c mm 31 o Hd De RR 31 14 Interpreting Printed Results Ml k kk kk eee eee A KK KA 32 14 1 Understanding the DPOAE Printout sccccssssssessoussecccnscscnensssessoussscuenssscneusssestoususeseussscneusssens 32 14 2 Understanding the TEOAE PELIDUOUL s yi eie tole tua olg bek eh k huc Idea taco a LEER UR ENT W n eb N A Kab k 33 15 ROU ICING ReSulES i N NNN Dy N r XM eee 34 16 Clock SENOS accesses see rset eee RE dUN AE NRUUSMN RE N
19. nstrument Settings Save Mode on page 38 for more information on the EROeSCAN save mode options 10 9 Test Technique As with other otoacoustic emission test instruments there is a technique to learn when using the EROeSCANS instrument especially while testing infants Experience with existing OAE systems suggests that it may take up to 3 months to become completely proficient at screening infants When testing an infant with the EROeSCAN 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 Pull gently down and back on the pinna to straighten out the ear canal Gently place the probe tube into the infant s ear canal When testing children and adults pull gently up and back on the outer ear during insertion to straighten the ear canal and ensure proper placement 21 8106286 Rev A M A ERO SCAN Operating Instruction MAICO 10 10 Noise Sources When the noise level exceeds the noise rejection limit of the instrument the orange NOISE light will appear It is common for the NOISE light See Figure 1 page 12 to appear while testing The light will appear infrequently if the noise 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 soun
20. of the device allow the user to control testing and printing and to reset test protocols The Micro Probe houses speaker and microphone which produce test stimuli and measure the sound pressure level SPL present in the sealed ear canal Interface of the instrument to the ear canal is accomplished through disposable eartips which fit onto the probe tube The disposable eartips are color coded to facilitate easy selection by size 12 8106286 Rev A M A ERO SCAN Operating Instruction MAICO 8 2 How are the Results Stored and Reported When the EROeSCANS 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 EROeSCANS instrument is capable of storing up to 250 test results The results are displayed via the OLED on the front of the device and are stored in the device s internal memory After testing is completed results can be printed using the printer and or exported to a computer Test results are stored in the non volatile 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 defined by the user and may vary depending on environmental and operating conditions The presence of otoacoustic emissions suggests normal outer hair cell function which in turn correlates to
21. refer criterion Display 23 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 This is in addition to meeting the other pass criteria including the minimum SNR and the number of passing frequencies for overall test 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 WNEXT The minimum DP amplitude when ON is 5 dB SPL The minimum TE amplitude selections are 5 and 10 dB SPL The Clock Mode menu Display 24 allows the user to change the clock from a 24 hour mode to a 12 hour mode To change the clock mode press the CHANGE keys Press the WNEXT to exit this menu The Graph Style menu Display 25 allows the user to select from two options for viewing the results The SNR graph view shows the signal to ratio for each DP test frequency or TE test band The Value graph view shows the absolute emission and noise levels for each DP test frequency or TE test band See the section nteroreting Results on page 30 for further information 39 8106286 Rev A MAICO 17 8 Language LANGUAGE English lt CHANGE gt w NEXT Display 26 17 9 Reset to Default RESETO DEFAULT RESET 2
22. the reference for comparison roughly half the time Extended measurements of the noise distributions in both the DPOAE filter channel DP level and the rms average of the 4 adjacent channels N level indicate that the signal to noise ratio the difference between DP and N has a standard deviation of 5 5 dB As shown in Diagram 1 page 60 this implies a 10 96 probability of seeing a 7 dB SNR simply from the variability of the noise levels in the 2 filter sets Requiring an SNR of 6 dB in three out of four frequencies drops the probability of passing an ear with significant hearing loss to 1 96 or less NOTE By the binomial distribution two of three frequencies at gt 8 4 dB or three of six frequencies at gt 7 dB should also ensure less than 1 96 probability of passing a moderately severe hearing impaired infant Preliminary EROeSCAN trials with infants indicate that the tester s technique is the single most important variable in the pass rate on normal hearing infants Some testers pick up the technique see Operating Instructions section page 17 with only a couple of day s practice producing pass rates comparable to those for other DPOAE equipment they have used for months other testers take longer Occasional claims of extraordinarily low probabilities of missing an ear with hearing loss appear to be based on poor statistics As discussed by Gorga Mayo Clinic Teleconference 1998 since the incidence of significant hearing
23. AN has been tested for EMC emissions and immunity as a standalone instrument Do not use the EROeSCAN adjacent to or stacked with other electronic equipment If adjacent or stacked use is necessary the user should verify normal operation in the configuration 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 Electromagnetic Compatibility Although the instrument fulfills the relevant EMC requirements precautions should be taken to 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 Electrical Safety EMC and Associated Standards 1 UL 60601 1 Medical Electrical Equipment Part 1 General Requirements for Safety 2 IEC EN 60601 1 Medical Electrical Equipment Part 1 General Requirements for Safety 3 CAN CSA C22 2 No 60601 1 Medical Electrical Equipment Part 1 General Requirements for Safety Electrical Equipment for Laboratory Use 4 EC EN 60601 1 1 Collateral Standard Safety Requirements for Medical Electrical Systems 5 EC EN 60601 1 2 Medical Electrical Equipment P
24. Do not clean or reuse eartips Probe tubes are disposable and should be replaced when clogged If a probe tube is reused after removal from the probe head it will not sit as tight as before Do not attempt to clean probe tubes This may cause damage to the probe Do not drop or otherwise cause undue impact to this device If the instrument is dropped or otherwise damaged return it to the manufacturer for repair and or calibration Do not use the instrument if any damage is suspected 8106286 Rev A M A ERO SCAN Operating Instruction MAICO 5 2 Warning Electric Shock Hazards WARNING DPO not open the case of the EROeSCAN Instrument Refer servicing to JX qualitied personnel Do not touch the contacts on the bottom of the instrument and the patient at the same time Do not connect the instrument to the patient and the PC at the same time 5 3 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 15 5 4 Warning Explosion WARNING This system is not explosion proof Do not use in the presence of JIN flammable anesthetics or other gases 5 5 Warning Battery Safety not user replaceable and must be returned to an authorized MAICO This instrument contains a rechargeable lithium ion battery The battery is WARNING N service location for repair 5 6 Warning General e Pro
25. GHT arrow keys to CHANGE the selection NOTE If you push the WDOWN arrow key without holding it for 3 seconds you will scroll through date and time etc rather than accessing the custom menus 44 8106286 Rev A MAICO M A ERO SCAN Operating Instruction 19 2 Selecting the Averaging Time AVERAGING Jii ES RS lt CHANGE gt w NEXT Display 34 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 A 32 second average would produce a test in about 32 seconds This timing does not reflect the Probe Check process The possible settings for the Averaging Time are as follows 4 8 16 32 or 64 seconds 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 WNEXT key to exit Display 34 19 3 Setting the PASS SNR Level PASS SNR 4 lt CHANGE gt w NEXT Display 35 In order to provide a PASS REFER determination for each test the PASS SNR must be set This number refers to the number of decibels that the TEOAE signal must be above the noise to be considered a PASS at that frequency The limits for the PASS SNR are 3 dB to 10 dB Pressing the lt LEFT or RIGHT gt arrow keys will increase or decrease
26. Left Pass 4 The protocol selected e g DP 4s EN 5 The averaging time used for this test e g 4 sec avg 2 0 mum 6 Instrument Probe serial number SN jj mmn unm 7 The ear selected Right or Lefb 5 0 nnnm 8 A PASS REFER indication if there is a criterion set for the fii 0 NF 8 DP F2 DP NF SNR F2 DP NF SNR selected protocol The open blocks indicate the noise floor in dB SPL rhr rmm 10 The solid blocks indicate the emission level in dB SPL aae a BUE 11 The f2 frequency in kHz e g 2 0 3 0 4 0 5 0 12 The level of the emission in dB SPL DP 13 The noise floor in dB SPL NF Figure 13 14 The signal to noise ratio SNR DP NF 32 8106286 Rev A M A ERO SCAN Operating Instruction MAICO 14 2 Understanding the TEOAE Printout The following information is provided for each test Figure 14 Wi MAICO EROSCANQAZ 1 The software version number e g V100 01 cy frs s 2 The time and date of the test based on the setting of the TE 32s 10 sec aug internal clock if the clock is set correctly this time and date SN PMEI001003 ME2001005 will be correct BEER ro xwar n yan na esa 3 The test number if operating in Save 250 mode Left Pass 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 number SN 7 The ear selected Right or Left 0 nmm 8 A PASS REFER indication if there is a criterion set for
27. M Maico Diagnostics li So y j j ji i La www medicaldevicedepot com 1 877 646 3300 Operating Instruction EROeSCAN Screener Plus Diagnostic Plus M MAICO ERO SCAN Operating Instruction Table of Contents T Standards Conmpliali B cs lo sci kis ake ekayane keninanda a ane ka n nnn sa ne ka a CN da raa 1 M ll al Near ec er r r_ 2 2 1 mendo H qm c 2 3 Warnings Cautions and Errors K K jdE i LbKiSjkK K Z llllkkkkkkkkk kaka kak kaka kk AKA AKA nnns 3 3 1 SESLUSZERFOPIVISSSOBIBS eee ae ee me 5 4 Customer RespolHsiDIIE arcsec eee cree eee ene kaka kk kk kk ce EU KA AA KK AA 6 5 Safety PI CAUt OS 44 EEE kk kk aka kk k KAKA KAKA KA AA KA AA KA AA RAA A KA A A KAR KAKA RR WR 7 5 1 Cautions General EE o ka W n bawan b n k n ka m 7 5 2 Warning Electric Shock Hazards aces ii yasikasey i hel en kas bi y ne Vana B h Sei Money b h l ee a eh Sedi U KIR S d 8 5 3 Warning n Case of EMEEN i an Lel in ne b dites b n ak y ki aya eka dae Uto te n bU Ue tn DPA RE RAN 8 5 4 ba Es wal D gt X X eP P P PD_b_kYYUrERERRERER r rRr r a a Rm 8 5 5 alal Dor rrraraaX XrX rrmL mcmLm m mm mms Ds mmB mx _ mcx V m mc m ggpzzggmmg gg g yox 8 5 6 Manning we ca gt en en E uU 8 6 Recychnd DIs DOSO esea 9 7 Regulatory Symbols
28. OF EXPLOSION IF BATTERY IS REPLACED BY AN INCORRECT TYPE DISPOSE OF USED BATTERIES ACCORDING TO LOCAL REGULATIONS Do not place the battery in fire or heat the battery Do not connect the positive terminal and the negative terminal of the battery to each other with any metal object Do not place the batteries in microwave ovens high pressure containers or 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 fluid could cause damage to the eye This equipment is for professional use only Do not open the cover while printing The printer head might be hot Do not expose the printer to any liquid Do not disassemble the printer If printer is stored for a longer period of time store the battery separately For correct battery charging make sure to follow charging instruction MPT II printer MPT II rechargeable battery pack Thermal printer paper Printer Power supply charger with plug adapters 26 8106286 Rev A M MAICO 12 1 Operation Paper loading Battery pack insertion Power on ERO SCAN Operating Instruction Open the lid by pushing on the sides insert paper roll as shown and close the lid Figure 8 Figure 8 NOTE Reorder paper from Maico or your local distributor Insert battery as shown Figure 9 Figure 9 Push POWER BUT
29. RDS ONLY IN ACCORDANCE WITH ANSI AAMI ES60601 1 2005 3rd ed and E359876 CAN CSA C22 2 No 60601 1 2008 11 8106286 Rev A M MAICO 8 Introduction ERO SCAN Operating Instruction The purpose of the EROeSCAN 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 The EROeSCANS is available as a Screening or Diagnostic version Please see chapter 18 and 19 for further information 8 1 How Does the EROeSCAN Device Work Probe Connector Test Status Indicators Display User Interface Buttons Charge Status Indicator Micro USB Connector Figure 1 The system consists of the instrument Micro Probe single use eartips replaceable probe tubes and other accessories The EROeSCAN instrument contains the hardware and software for generating the test stimuli measuring and displaying the OAEs and storing the results until 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 the device The instrument uses an organic light emitting diode OLED display screen and three light emitting diodes LEDs to provide a visual display of test status to the operator Four membrane type push buttons located on the keypad
30. TON 19 OFF One short beep will be heard at power ON two short beeps at power OFF for two seconds in order to power ON or QE Green Power indicator will be lit if printer is MPT 8MAICO powered by battery Figure 10 Figure 10 2 8106286 Rev A ERO SCAN Operating Instruction Indicators Green LED indicator Blue LED indicator Fast flash Charging Poweron Battery nearly Charging Power On completed Charging Power Off completed Power ON battery Slow flash amp Slow flash 5 Out of paper Beep Slow flash o Off O Sleep mode EEE Self test While printer is powered OFF press and hold PAPER FEED s button then press and hold POWER BUTTON simultaneously When beep is heard after approx 3 seconds release both buttons and a test page will print with information on current status and character samples Paper feed When powered press PAPER FEED amp long as the button is pressed button Paper will feed as Bluetooth setup Pairing with the instrument is necessary before printing via Bluetooth is possible Pairing process Power on printer Let the instrument PC search for other Bluetooth9 devices A device called MPT II should occur in the list of devices When prompted enter password 1234 Finish pairing 28 8106286 Rev A M MAICO ERO SCAN Operating Instruction NOTE Do not have several printers powered on and within range while searching
31. UM UMNE MEE 35 16 1 MP oe aun aee iia o 35 162 Chaneine daB Iz AMT TK l ayn k kenl 35 T 8106286 Rev A M A ERO SCAN Operating Instruction MAICO 17 Instrument S MING S saiya bank anaenene csi E dka S Sakan EE 36 17 1 Bluetooth Device Pairing ccccccccecsccssescececescecesceceseecsceececaceecscsceecscscevseeecacseeesacsececaceecavsceevaceecevacen 36 YA BR dewe TS Re 0 ee ee ern 37 TAN MEE Unos velo IM sis s54y U m 37 17 4 SaveMode Storing Test Results isses rire kk odo ERR Pe EKA KEKE KAKA KK Rr adus OPI KEK YA 38 179 JMinimum AmDIll U m RO m mm 39 UP MEG uoo RE m omm 39 Ur ME E em 39 DS uiu E 40 FO RESET TOD N e EAA 40 18 Advanced Options for DPOAE Testing e serene 41 18 1 Instructions for Customizing a Test PIFOLtOCO h EE kk k k keke nnns 41 18 2 Selecting the Level of Primary TO S keke eke ke nnne nene nere aeneae sereno nenas 42 15 3 Seting the Averaging Dig 4 eiost poe eere W n ee GA bena be k le ebed Ka B be Ew bA ba n eb vom duc MERO RE n A kawa 42 15 34 OURS the PASS SNR Leye l i xan n da ena ae bun an b n va keya eb k ya tee 42 18 5 Setting the Number of Frequencies for PASS keke eke keke kK Kek KK K KK KA 43 i E cd unes
32. aminated 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 Annual calibration is recommended Have an authorized service technician perform electrical safety checks on the unit in order to maintain continued compliance to 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 attempt to clean the probe tube To replace the probe tube use the eartip to grasp the probe tube the clear plastic tube and twist slightly while pulling the probe tube straight out of the probe head Figure 16 Figure 16 Dispose of the used probe tube immediately to avoid confusing used tubes and new tubes Take a new probe tube from the package and insert the tube into the probe head until it is fully seated Figure 17 A properly inserted probe tube will snap securely into place when it is fully seated in the probe head Figure 17 NOTE If the probe tube is re used after it was removed from the probe head once it will not sit as tight as before CAUTION DO NOI ATTEMPT TO CLEAN PROBE TUBES THIS MAY CAUSE DAMAGE TO THE PROBE 48 8106286 Rev A MAICO M A ERO SCAN Operating Instruction 21 Troubleshooting
33. art 1 Electromagnetic Compatibility Requirements and Tests 6 Essential Requirements of the current European Union Medical Device Directive 93 42 EEC 7 RoHS Restriction of the use of certain Hazardous Substance 8 WEEE Waste Electrical amp Electronic Equipment Legislation 62 8106286 Rev A M A ERO SCAN Operating Instruction MAICO Guidance and Manufacturer s Declaration Electromagnetic Emissions The EROeSCANS is intended for use in the electromagnetic environment specified below The customer or the user of the EROeSSCANS should assure that it is used in such an environment Emissions Test Compliance Electromagnetic environment Guidance RF Emissions Group 1 The ERO SCAN uses RF energy only for its CISPR 11 internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The EROeSCAN is suitable for use in all CISPR 11 commercial industrial business hospital and IEC 61000 3 2 Voltage Fluctuations Complies Flicker Emissions IEC 61000 3 3 Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the EROeSCAN The ERO SCAN is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the EROeSCAN can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communic
34. ations equipment transmitters and the EROeSCAN as recommended below according to the maximum output power of the communications equipment Rated Maximum Separation distance according to frequency of transmitter Output Power of m Transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz W d 1 17NP d 1 17VP d 2 23vP For transmitters rated at a maximum output power not listed above the recommended separation distance c in meters m can be estimated using the equation applicable to the frequency of the transmitters where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply to all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 63 8106286 Rev A M MAICO ERO SCAN Operating Instruction Guidance and Manufacturer s Declaration Electromagnetic Immunity The EROeSCANS is intended for use in the electromagnetic environment specified below The customer or the user of the EROeSCAN should assure that it is used in such an environment Immunity Test Electrostatic Discharge ESD IEC 61000 4 2 Electrical Fast Transient Burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage Dips Short Interruptions and Voltage Variations on Power Supply Lines IEC 61000 4 11
35. battery is fully charged This identifies that the charging cycle has been completed or was not implemented because the battery was already fully charged e Slow blink illumination indicates that the charging function is in process e Fast blink illumination indicates a fault condition in which the user would be directed by the user manual to return the instrument for service During instrument operation the user is warned of a low battery condition by the following illumination of the CHARGE indicator e Two fast blinks followed by a pause and then repeated until the battery is charged 9 3 Installing the Micro Probe e Ma n N gt a C Figure 4 Turn off the ERO SCAN and insert the Micro Probe connector into the socket on the top of the EROeSCAN 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 plug and socket should be visually inspected prior to each installation of the remote probe If damage is observed contact MAICO Diagnostics 15 8106286 Rev A M MAICO 9 4 Attaching Eartips i Figure 5 Gar Figure 6 ERO SCAN Operating Instruction The EROeSCANS 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 inserti
36. ce startup once per day For a DP test the desired level L1 or L2 cannot be obtained within allowable limits User should retit 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 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 low User should refit the probe and retry the test Replace the probe tube Contact MAICO for service if the problem persists across several patients 50 8106286 Rev A M A ERO SCAN Operating Instruction MAICO Solutions e Overflow error during the calculation of the DFTs for a DP test User should repeat the test e Cycle instrument power e Contact MAICO for service if the problem persists Memory almost full e Saved tests are within 5 tests of the maximum limit Print or transfer test result to avoid interruption in testing Memory Full e The maximum saved test limit is reached The user will need to clear the memory before any additional tests can be performed Power Low e The battery charge level is too low for operation The user must charge the battery before additional tests can be performed Printer Error e Indicates a problem with the printer Check the printer status e Reset the printer
37. ds Any noise in the ear canal at the time of testing can mask this emission This noise can come from a variety of sources The largest source of noise can come from the patient This is biological noise such as movement coughing sucking talking etc The patient must be calm and not move or talk Ambient noise in the testing environment can also be a large source of noise during the test A properly sealed eartip can block a large amount of this noise but performing the testing in a relatively quiet environment is recommended 10 11 Turning Off the Instrument The EROeSCANS instrument has an automatic shutdown feature designed to prolong battery life The unit will automatically shut down after 1 minute default of inactivity To turn it back on simply press the large WDOWN key This feature can be re programmed for various periods of inactivity before shutdown See the Changing nstrument Settings Auto Shutdown Time on page 37 NOTE The AUP arrow can be used to manually power off the instrument 22 8106286 Rev A M A ERO SCAN Operating Instruction MAICO 11 Managing Results Users have the option of printing to the thermal printer or transferring results to the EROeSCAN PC Database Each EROeSCANS 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 EROeSCAN instrument automatically saves the re
38. e instrument is used adjacent to other devices or equipment the user is instructed to verify that no disturbance is found in the operation of this or other equipment in proximity This icon indicates that patient applied parts of the instrument conform to IEC 60601 1 2005 Type B requirements 3 8106286 Rev A M A ERO SCAN Operating Instruction MAICO Instruments which bear the Underwriters Laboratories Inc label should be interconnected with accessories that have the proper oS electrical compatibility and are listed as meeting the requirements of the UL Medical and Dental Equipment Standard Connection of L accessories not meeting these requirements may result in electrical E359876 leakage currents in excess of those allowed by the standard and present a potential electrical shock hazard to the person being tested Any program aimed at obtaining reliable measurements of otoacoustic emissions should be staffed and supervised by appropriately trained individuals 4 8106286 Rev A MAICO M A ERO SCAN Operating Instruction 3 1 Status Error Messages Display Messages Attach Probe BT Device Not Found BI Error xxx BT Not Configured Device not Responding Due For Service Fit Error Cannot Obtain L Fit Error Too High Fit Error Too Low Limit Error Memory Almost Full Memory Full Power Low Printer Error Printer Paper Out Time Date Error No probe is detected at the start o
39. e Level of Primary Tones LEVEL Ll 65 lt CHANGE gt w NEXT Display 28 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 28 and press WNEXT to move to the L2 screen Press the WNEXT key to set the level of L2 as with L1 above 18 3 Setting the Averaging Time AVERAGING TIME 1 lt CHANGE gt w NEXT Display 29 The Averaging Time can be changed to one of four settings The Averaging Time will have a large impact on the time required to pertorm the test and on the signal to noise ratio SNR A 2 second average for 6 frequencies would produce a test in about 18 seconds which includes the Probe Check sequence The possible settings for the Averaging Time are as follows 0 5 sec 1 0 sec 2 0 sec or 4 0 sec Press the CHANGE keys to select an option and the WNEXT key to exit Display 29 NOTE Longer averaging times help to reduce the noise floor which can improve the likelihood of obtaining a passing result particularly with a noisy patient like a baby sucking a pacifier or in a noisy environment However shorter averaging times may be preferred for young children and or uncooperative patients 18 4 Setting the PASS SNR Level PASS SNR 6 lt CHANGE gt w NEXT Display 30 In order to provide a PASS REFER determination for each test
40. e of clicks and calculates the voltage required to obtain the target peak pressure If the desired peak pressure cannot be obtained the unit will use the maximum voltage The test phase consists of measuring the response obtained from repeated sequences of clicks applied to the receivers The click sequence is 3 1 1 1 repeated twice Signal and noise floor estimates are obtained by adding subtracting the two response sequences respectively The energy of the signal and noise floor estimates in various frequency bands is obtained in real time and displayed once per second The average peak pressure of the stimulus is calculated after completion of the test Artifact rejection is employed during the test phase to reduce the effect of transient noise bursts by the use of an adaptive rejection threshold The unit attempts to accept the quieter sections of the test while rejecting the noisier portions of the test When the noise level is approximately constant during the test the instrument will tend to accept most of the data in the test However as the level of the noise becomes more variable over time the instrument will attempt to accept the quieter portions of the recording Noise estimates are obtained approximately 32 times per second and a suitable threshold is estimated from the data Data segments with a noise floor above this threshold are rejected which tends to lower the noise 56 8106286 Rev A M A ERO SCAN Operating Instructi
41. ejection is employed during the test phase to reduce the effect of transient noise bursts Immediately after the test button is pressed the Probe Check phase of the test begins Probe Check phase checks both the quality and stability of the seal by measuring the response obtained from a sequence of test tones The stability of the seal is determined by comparing the responses obtained over time When the level of the response is within an acceptable range and is stable over time the unit proceeds to the calibration phase FOR DPOAE The calibration phase automatically measures the response obtained from a sequence of calibration tones and calculates the voltage needed to obtain the desired pressures If the desired peak pressure cannot be obtained the unit will use the maximum voltage A successful calibration leads to the actual test phase The test phase consists of measuring the response obtained from the pairs of test frequencies f1 12 applied to the receivers Two receivers are used with each receiver generating one frequency in order to reduce intermodulation distortion Frequency domain 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 averaging the power in the 4 closest 2 bins to the DP bin FOR TEOAE The calibration phase automatically measures the peak pressure obtained from a sequenc
42. en the probe check is anywhere in the green area Display 5 the ear canal volume is in the target area for testing to begin The test will begin automatically if the probe fit is stable Appropriate adjustment of the probe eartip position and eartip size selection should be made until the indicator falls within the green area and remains stable If the test will not progress past the Probe Check phase change the probe tube check that the probe connector is fully seated in the socket and try again NOTE Do not remove or insert the probe from the probe connector unless the device is off When a seal is obtained the unit will automatically begin testing AutoStart and the yellow TEST LED will illuminate throughout the test NOTE To test children with PE tubes the AutoStart needs to be disabled This is accomplished by first inserting the probe with appropriate ear tip into the ear canal and obtaining a proper seal To disable AutoStart at the main menu select the ear to be tested by holding down the LEFT or RIGHT arrow keys for 3 seconds until the green TEST light turns off Once the key is released the EROeSCANS will calibrate and test as before 19 8106286 Rev A MAICO M A ERO SCAN Operating Instruction 10 7 Calibration and Test 10 8 Viewing Results EAR fest wv REVIEW Display 8 The EROeSCAN instrument will automatically perform a calibration prior to the start of each test During calib
43. enne nnns 58 Appendix D Configurations and Test Protocols 61 Appendix E EMC Compatibility 2 ness ad oi eiua ox oux LER kk kk kk kk kk 62 IV 8106286 Rev A M MAICO ERO SCAN Operating Instruction 1 Standards Compliance Standard ANSI ASA 3 6 IEC 60601 1 IEC 60645 1 IEC 60645 3 IEC 60645 6 ISO 14971 ISO 10993 EN 60601 1 2 FCC Part 15 UL 60601 1 Issue Date 2010 2007 2004 2007 2010 2007 2009 2007 2005 Title Specification tor Audiometers Medical Electrical Equipment General Requirements for Basic Safety and Essential Performance Ed 3 Electroacoustics Audiological equipment Part 1 Pure tone audiometers Electroacoustics Audiometric equipment Part 3 Test signals of short duration Electroacoustics Audiometric Equipment Part 6 Instruments for the measurement of otoacoustic emissions Application of Risk Management to Medical Devices Biological Evaluation of Medical Devices Medical electrical equipment Part 1 2 General requirements for basic safety and essential performance Collateral standard Electromagnetic compatibility Requirements and Tests FCC 47CFR Part 15 247 amp 15 249 Bluetooth Clause 8 9 1 8 Pollution Degree Classification 2 1 8106286 Rev A M A ERO SCAN Operating Instruction MAICO 2 Warranty MAICO Diagnostics warrants that this product is free from
44. es there are two default test protocols that vary by averaging time Appendix D contains complete information on protocol settings For instructions for customizing diagnostic protocols review chapter 18 and 19 NOTE Screener default protocols cannot be customized Diagnostic protocols are customizable 18 8106286 Rev A lt AICO ERO SCAN Operating Instruction 10 6 Probe Check Beginning a Test PROBE CHECK Display 3 PROBE CHECK Display 4 PROBE CHECK Display 5 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 To begin a test insert the probe into the ear and select either the LEFT or RIGHT arrow key to indicate which ear will be tested After the test ear is selected the Probe Check screen will be shown This display shows a horizontal bar graph representing the ear canal volume and at the same time the fitting of the probe When the bars are in the orange to the left Display 3 this represent a very large ear canal volume or the probe is not inserted into the ear or place properly When the bars are all the way to the right Display 4 this represent the volume is too small for the test to begin or probe tip is blocked Reinsertion and or inspection of the probe tip is necessary Wh
45. es are displayed on the EROeSCANS Unit in the same order as displayed on the Database Software To move to a different name than the one displayed on the EROeSCANS screen use the left or right arrows to cycle through the names until the desired name is on the display A patient named Unnamed is always included at the beginning of the EROeSCAN list for instances when a patient is being tested but the patient name was not transferred to the EROeSCAN It is recommended that you go to the Test Results Clear screen Display 19 page 37 to clear any previous memory locations after you changed the save mode setting NOTE When using the 250 test mode it is important to keep a record of the test number for each patient When 245 tests have been saved the user will be warned that the memory is almost full When the EROeSCAN unit reaches 250 saved tests it will not allow any further testing At this point either the results must be printed transferred to the PC software or they must be cleared from memory 38 8106286 Rev A M MAICO ERO SCAN Operating Instruction 17 5 Minimum Amplitude MIN VALUE OFF lt CHANGE gt w NEXT Display 23 17 6 Clock Mode Ole Bulo 24 Hour lt CHANGE gt w NEXT Display 24 17 7 Graph Style GRAPH SNR lt CHANGE gt w NEXT Display 25 The Minimum Amplitude setting allows the user to set the unit to include minimum amplitude values in the pass
46. ese guidelines may not apply to 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 TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the EROeSCAN is used exceeds the applicable RF compliance level above the EROeSCAN should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the ERO eSCANS b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 65 8106286 Rev A
47. eviewed after the test is complete The display might differ depending on the settings used for the test Pe tc di N Q i v a o o nm Q 2 Q ad min G o anum N Each column represents an individual frequency Figure 12 The display above shows a 6 column graph Figure 12 Each frequency DPOAEs or frequency band TEOAES is indicated by one column The EROeSCANQ allows the user to select from two options for viewing the results The SNR graph view shows the signal to noise ratio for each DP test frequency or TE test band The Value graph view shows the absolute emission and noise levels for each DP test frequency or TE test band 30 8106286 Rev A MAICO 13 2 SNR Graph View Display 11 M A ERO SCAN Operating Instruction 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 The height of each column represents the SNR measured When a protocol with a PASS criteria has been selected the user will see a horizontal green line at the decibel level corresponding to the SNR required for a pass Green vertical bars 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 criteria Is set in the device For more in
48. f a test The paired Bluetooth9 device cannot be detected The device may be turned off or too far away There is an error condition with the Bluetooth9 device Check the status The EROeSCAN instrument is not paired with any Bluetooth device The printer is not responding to queries from the instrument Indicates calibration of instrument is recommended Message will appear upon the calibration due date set in the device Message appears during device startup once per day For a DP test the desired level L1 or L2 cannot be obtained within allowable limits User should refit the probe and retry the test For a DP test the level of the calibration tone is too high User should refit the probe and retry the test For a DP test the level of the calibration tone is too low User should refit the probe and retry the test Overflow error during the calculation of the DFTs for a DP test User should repeat the test Saved tests are within 5 tests of the maximum limit The maximum saved test limit is reached The user will need to clear the memory before any additional tests can be performed The battery charge level is too low for operation The user must charge the battery before additional tests can be performed Indicates a problem with the printer Check the printer status Indicates that printer paper has run out The clock is checked during power on to ensure it has not lost time and been reset In the case of clock reset
49. formation on this see Setting the PASS SNR Level on page 42 13 3 Value Graph View Display 12 shows the Value graph view for right ear test Red circle symbols represent the absolute emission levels at each DP test frequency or TE frequency band For the left ear dark blue X symbols will represent the absolute emission levels at each DP test frequency or TE frequency band White upside down triangles represent the noise floor at each DP test frequency or TE frequency band Refer to page 39 for instructions to switch the default setting of the graphs between the SNR Bar Graph and Value Graph 31 8106286 Rev A M MAICO ERO SCAN Operating Instruction 14 Interpreting Printed Results Results from the EROeSCANS can be transferred to a portable thermal printer or the EROeSCANQG Database Software for a full page printout The information as specified in section 14 1 and 14 2 is included on both printouts For instruction on printing from the database see the EROeSCAN Database Software Manual 14 1 Understanding the DPOAE Printout The following information is provided for each test Figure 13 1 The software version number e g V100 01 IBMAICO EROSCANQAZ 2 The time and date of the test based on the setting of the we internal clock if the clock is set correctly this time and date 001 DP 4s 4 sec aug will be correct wis adana 3 The test number if operating in Save 250 mode e 9 001
50. full precision value for the SNR must be equal to or greater than the pass criterion 5 dB in this example for the P to be printed A similar apparent problem can occur in which the printed SNR value appears to be incorrect If the actual values were TE 4 5 dB NF 0 4 GB resulting in SNR 4 1 dB the printed values would be TE 5 dB NF O SNR 4 The printed SN value of 4 dB appears to be an error but is in fact correct 34 8106286 Rev A M A ERO SCAN Operating Instruction MAICO 16 Clock and Date Settings When the EROeSCANS 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 The clock should be set prior to testing as changing 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 Seasonal time changes such as Daylight Saving Time will also require resetting the clock If the instrument is being powered on for the first time or if the instrument s battery is completely discharged and the battery is not charged within approximately one hour a TIME DATE ERROR message will occur If this message appears reset the time and date 16 1 Accessing the Clock Menu To change the time and date press WCHANGE at the main menu Display 1 page 18 and then press WSETUP at the protocol 0 7 MAR 14 se
51. ge 35 If a time date error message is indicated follow the instructions in this section to set the correct date and time 10 3 Control Panel The EROeSCANS instrument uses 4 buttons to control all functions L gt 4 of the instrument Figure 7 These buttons are arranged in a directional cursor format The arrows on the keypad LEFT RIGHT AUP and YDOWN correspond to the arrows that are f N used on the screen The screen will indicate which button to push Figure 7 by showing the appropriate arrow NOTE The AUP key will always bring the instrument back to either the previous menu or the main menu The AUP key will also access the print command trom the Main Menu 17 8106286 Rev A MAICO 10 4 Main Menu Date amp Time Start Left Ear Test Change Protocol and Settings M A ERO SCAN Operating Instruction Selected Protocol Battery Status D 19 1 TEST Start Right w CHANGE Ear Test Display 1 10 5 Selecting the Test Protocol PROTOCOL DET LS lt CHANGE gt wv SETUP Display 2 The currently selected protocol is shown on the Main Menu Display 1 To change the selected protocol press WCHANGE at the Main Menu The Change Protocol display will appear Display 2 Use the CHANGE arrow buttons to change the selected protocol Press the AUP arrow to return to the Main Menu to begin testing Press the WSETUP to enter the setup menus For either DPOAEs or TEOAEs screener devic
52. harging The battery status is indicated by the battery icon shown in the upper right corner of the Main Menu Display 1 page 18 Full battery charge is represented by a full battery symbol on the display and reduces to an empty battery in increments corresponding to the discharge of the battery NOTE e Battery life will vary depending on each product configuration e The maximum capacity of this battery will decrease with time and usage e For maximum battery life do not completely deplete the battery but charge when 5 10 96 of the battery remains 14 8106286 Rev A Figure 2 CHARGE PAW COLO Figure 3 ERO SCAN Operating Instruction The Micro USB port on the bottom of the instrument is used for charging via the power supply Connect the charger as shown in Figure 2 NOTE Misalignment of the plug and socket can cause damage The plug and socket should be visually inspected prior to each installation 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 During battery charging the indicator will be lit whenever the Micro USB connector is engaged and powered The rate of illumination of the indicator provides a means of identifying the status of the charging function and is defined as follows e Steady state illumination indicates that the
53. he menu NOTE DPOAE Menu and TEOAE Menu are not accessible in the EROeSCAN Screening version SYSTEM MENU NEW BT DEVICE DISCOVER gt NEXT G TEST RESULTS amp CLEAR gt wv NEXT POWER OFF 1 minute lt CHANGE gt wv NEXT SAVE L R TESTS lt CHANGE gt NEXT MIN VALUE OFF lt CHANGE gt v NEXT eee dRwo 24 Hour CHANGE gt wv NEXT LANGUAGE English lt CHANGE gt v NEXT RESET TO DEFAULT RESET gt v NEXT DPOAE MENU L1 65 lt CHANGE gt wv NEXT LEVEL L2 55 lt CHANGE gt w NEXT AVERAGING TIME 4 lt CHANGE gt wv NEXT PASS SNR 6 lt CHANGE gt w NEXT 3 FREQS FOR PASS lt CHANGE gt w NEXT RESET PROTOCOL CORESEI 2 w NEXT SAVE PROTOCOL lt SAVE gt v DONE 29 M A ERO SCAN Operating Instruction TEOAE MENU AVERAGING TIME 64 lt CHANGE gt wv NEXT PASS SNR 4 lt CHANGE gt w NEXT 3 FREQS FOR PASS CHANGE gt NEXT RESET PROTOCOL G RESET gt w NEXT SAVE PROTOCOL SAVE gt w DONE 8106286 Rev A M A ERO SCAN Operating Instruction MAICO 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 r
54. he instrument to power off Powering the instrument back on again should reset restore normal function Contact MAICO for service if the problem persists 49 8106286 Rev A m MAICO BI Device Not Found BI Error XXX BT Not Configured Device Not Responding Due for Service Fit Error Cannot Obtain L Fit Error Too High Fit Error Too Low ERO SCAN Operating Instruction Solutions Probe not detected Check that the probe connector is fully seated in the socket Disconnect and reconnect the probe Cycle instrument power Contact MACIO for service if the problem persists Paired to Printer o Check that the printer is turned on o Move closer to the printer o Try again Paired to PC Computer or Bluetooth dongle o Check that the serial port is open Establishing the serial port is handled by the PC and or the software not by the EROeSCAN instrument Check BT device printer or PC status Attempt to connect to BT device again Contact MAICO if the problem persists Printing has been attempted but no BT device is paired with the EROeSCAN Instrument Establish Bluetooth pairing The printer is not responding to queries trom the instrument Check printer status Awaken printer from sleep mode Charge printer battery if necessary Indicates calibration of instrument is recommended Message will appear upon the calibration due date set in the device Message appears during devi
55. lection display Display 2 page 18 The current date and time 14 54 presently set in the unit will be shown Display 13 If the time and date are correct press the AUP key to escape back to the main CHANGE menu Display 13 NOTE When a Teal arrow is displayed for a wDOWN arrow this represents an alternative menu is available To access hold the vY DOWN arrow for 3 seconds until the READY light green LED turns off and release the key 16 2 Changing the Date Time If either the date or time is incorrect press the WCHANGE key to Month access the menu to change the month Display 14 Press the lt MAR gt lt LEFT or RIGHT gt keys to scroll forward or backward through the months NEXT You will see the abbreviated name for each month Display 14 Display 14 When the desired month appears on the display press the WNEXT key to enter the day selection screen Pressing the LEFT or RIGHT keys will scroll through the days of the month Repeat this process for the year hour and minute using the LEFT or RIGHT Minute arrow keys to make the selection and the WNEXT key to advance C 54 to the next display When the correct minute is selected pressing the WDOWN arrow key Display 15 will return to the Main Menu The time and date w DONE Display 15 changes are automatically saved 35 8106286 Rev A M MAICO ERO SCAN Operating Instruction 17 Instrument Settings The EROeSCANS instrume
56. nal factory settings Press the WNEXT key to exit NOTE This does not affect the instrument settings or the settings of any other protocol Once all of the settings have been selected for the protocol these settings can be saved by selecting the SAVE keys Display 38 Press the WDONE key to exit Selection of YDONE before saving will not save the selections made to the protocol 46 8106286 Rev A M A ERO SCAN Operating Instruction MAICO 20 Cleaning and Maintenance 20 1 Cleaning and Disinfection Use a 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 Disinfection of the probe tube between patients is not required External parts of the instrument probe can be cleaned to remove visible particulate contamination Do not attempt to insert any object into probe This instrument is not designated as a sterile device Wiping with a clean cloth or towel and a mild non alcohol based disinfecting solution provides a suitable form of cleaning and low level disinfection of the housing and probe exterior Repeat this weekly or as often as conditions warrant to prevent a build up of grime from normal handling and use We believe low level disinfection is appropriate for this type of instrument This may not conform
57. ng it into an ear canal The determination of the appropriate eartip size should be made by persons with proper training and experience The eartip must seal the ear canal The best test results are obtained when the eartip is inserted deeply into the ear canal instead of flush with the ear canal opening Caution must be taken however to ensure that the eartip does not extend too deeply into the ear canal Use only the eartips approved for use with the instrument The eartips 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 slightly while pushing it onto the probe is recommended Be sure the eartip is fully seated on the probe There should be no gaps between the eartip and the collar of the probe head Figure 6 To remove the eartip grasp the eartip at the base and twist it while pulling it straight off the end of the probe tube Grasping the base of the eartip will prevent the probe tube from being inadvertently pulled out of the probe head along with the eartip NOTE If the probe tube becomes dirty or clogged it must be replaced See the section Probe Tube Replacement Chapter 20 3 for further information 16 8106286 Rev A M A ERO SCAN Operating Instruction MAICO 10 Operating Instructions 10 1 Preparing the Patient for Testing Otoscopic examination of the patient s ear
58. nt 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 To access the menus to change these functions press wCHANGE at the main menu Display 1 page 18 and then press WSETUP at the Protocol Change Display 2 page 18 to enter the Clock menu Display 13 page 35 At the Clock menu hold down the WCHANGE key for 3 seconds until the READY light green LED turns off and release the key 17 1 Bluetooth Device Pairing NEW BT DEVICE lt DISCOVER gt NEXT Display 16 DISCOVERED PRI 54 81 lt CHANGE gt wv PAIR Display 17 BT DEVICE PAIRED wv MainMenu Display 18 The Bluetooth pairing menu Display 16 allows the user to pair the EROeSCAN unit with a Bluetooth device such as a thermal printer or personal computer for printing test results and data transfer The EROeSCAN unit can be paired with only one device at any time To establish Bluetooth9 pairing turn on the device that will be paired with the EROeSCANS unit e g thermal printer Then select lt DISCOVER gt to initiate discovery of available Bluetooth devices The EROeSCANS will search for available Bluetooth devices for approximately 15 seconds During this time the user will see the message Please Wait on the display
59. ol should be made only by qualified personnel 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 The EROeSCANS instrument comes with pre programmed protocol settings See Appendix D for the manufacturer settings of these protocols Test protocol changes are saved in the non volatile memory 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 YCHANGE at the main menu Display 1 page 18 2 Using the CHANGE buttons select the TEOAE protocol you want to customize the TE 64s protocol is not customizable 3 Press WSETUP at the Protocol menu Display 2 page 18 4 At the Clock menu Display 13 page 35 the teal arrow represents a custom protocol Hold down the Y CHANGE key for 3 seconds until the READY light green LED turns off 5 At the New BT Device menu Display 16 page 36 the teal arrow represents a custom protocol menu is available Hold down the Y CHANGE key for 3 seconds until the READY light green LED turns off You will now see the Averaging Time screen Display 34 page 45 You are in the TEOAE menu and will be able to scroll the available protocol parameters with the WNEXT button and make changes by using the LEFT or RI
60. on MAICO 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 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 times out of 100 This is not a limitation of the instrument but a fundamental property of the method used to estimate the SNR in all emission testing In order to reduce the occurrence of this false emission the instrument limits the minimum value of NF which has the effect of reducing the SNR for tests that have a low noise floor As the noise level of the test increases the user will notice that more false emissions will appear which is to be expected 57 8106286 Rev A M A ERO SCAN Operating Instruction MAICO 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 used as
61. or cycle the printer power Printer Paper Out e Replace the paper roll Time Date Error e 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 5 1 8106286 Rev A MAICO 22 Specifications MICRO PROBE SPECIFICATIONS Measurement Type Frequency Range Stimulus Intensity Range Microphone System Noise Dimensions and Weight Connector INSTRUMENT SPECIFICATIONS Power Supply Battery Life Dimensions and Weight User Interface Connectors Communications M A ERO SCAN Operating Instruction Distortion Product Otoacoustic Emissions DPOAE Transient Evoked Otoacoustic Emissions TEOAE Screener Plus version DPOAE 2 0 kHz to 5 0 kHz TEOAE 1 5 kHz to 4 0 kHz Diagnostic Plus version DPOAE 1 5 kHz to 12 0 kHz TEOAE 0 7 kHz to 4 0 kHz DPOAE 40 dB SPL to 70 dB SPL TEOAE 83 dB SPL peak equivalent x3 dB 20 dB SPL at 2 kHz 1 Hz bandwidth 13 dB SPL at 1 kHz 1 Hz bandwidth Length 1 0 meter 40 in Weight 28 g 1 00 oz HDMI Lithium lon rechargeable 1000 tests per charge minimum 20 hours on time Dimensions W X D X H 2 58 X 1 23 X 5 78 in Instrument Weight 180 g 6 4 oz OLED display to provide user information and progress of measurement 4 button keypad to control instrument functions Integrated USB communication capability for batte
62. orn distorted or contaminated should be replaced immediately with clean genuine replacement parts manufactured by or available from MAICO This product should not be used in the presence of fluid that can come into contact with any of the electronic components or wiring 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 Do NOT use the EROeSCAN in a highly oxygen enriched environ ment such as a hyperbaric chamber oxygen tent etc Equipment is not user repairable Repairs and battery replacement must be performed by a qualified service representative only CAUTION Use and store the instrument indoors only It is recommended that the instrument be operated within an ambient temperature range of 15 C 59 F to 35 C 95 F and in relative humidity between 30 96 and 90 96 non condensing X Transport and store the instrument in temperature between 5 C 4 F 1 to 40 C 104 F Annual calibration recommended Have an authorized service technician perform electrical safety checks on the unit in order to maintain continued compliance to IEC and UL 60601 1 6 8106286 Rev A M A ERO SCAN Operating
63. ory will print out automatically WAIT The EROeSCAN instrument will power off when printing is CANCEL complete Display 10 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 NOTE See the EROeSCAN Database Software Manual for instructions on printing from the Database Software 11 4 Connecting to the PC Database Software Connection to the PC database software is achieved by using the provided Micro USB to USB A cable or via Bluetooth 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 EROeSCAN instrument The EROeSCAN instrument will detect the connection to the PC and wait for an action or communication from the PC database software Bluetooth Connection Refer to the EROeSCAN Database Software Manual for connection via Bluetooth NOTE See the EROeSCAN Database Software Manual for instructions on using the application 25 8106286 Rev A MAICO M A ERO SCAN Operating Instruction 12 MPT II SANIBEL Mobile thermal mini printer Cautions General information MPT II printer kit includes RISK
64. per use of this device depends on careful reading of all instructions 3 8106286 Rev A M A ERO SCAN Operating Instruction MAICO 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 EEWEHIEN any other parts of this system Batteries may explode or cause burns if disassembled crushed or exposed es to fire or high temperatures 9 8106286 Rev A M A ERO SCAN Operating Instruction MAICO 7 Regulatory Symbols Symbol 980 amp 60601 1 Serial Number 980 amp 60601 1 Date of Manufacture Caution Consult Accompanying 980 amp 60601 1 Documents Return to Authorized Representative Special Disposal Required 980 amp 60601 1 980 amp 60601 1 Reference Number B Patient Applied Part According to IEC60601 1 980 amp 60601 1 W mm pw amina n m MAICO ER EN O Ee REP o 980 amp 60601 1 EU Authorized Representative Conforms to European Medical Device 10 8106286 Rev A 60601 1 LI E ints mum M MAICO ERO SCAN Operating Instruction KE A QA MEDICAL GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK FIRE AND MECHANICAL HAZA
65. pre programmed protocol settings See Appendix D for the manufacturer settings of these protocols Test protocol changes are saved in the non volatile 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 YCHANGE at the main menu Display 1 page 18 2 Using the CHANGE buttons select the DPOAE protocol you want to customize the DP 4s protocol is not customizable 3 Press WSETUP at the Protocol menu Display 2 page 18 4 At the Clock menu Display 13 page 35 the teal arrow represents a custom protocol menu is available Hold down WCHANGE key for 3 seconds until the READY light green LED turns off 5 At the New BT Device menu Display 16 page 36 the teal arrow represents a custom protocol menu is available Hold down the WCHANGE key for 3 seconds until the READY light green LED turns off You will now see the Level L1 screen Display 28 page 42 You are in the DPOAE menu and will be able to scroll the available protocol parameters with the WNEXT button and make changes by using the LEFT or RIGHT arrow keys to CHANGE the selection NOTE If you push the WDOWN arrow key without holding it for 3 seconds you will scroll through date and time etc rather than accessing the custom protocol menus 41 8106286 Rev A MAICO M A ERO SCAN Operating Instruction 18 2 Selecting th
66. ration a series of tones will be presented to the ear canal to calibrate the levels of the frequencies to be tested Following 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 emissions are measured and can be reviewed after the test is complete Each column represents one test frequency DP or frequency band TE The EROeSCANQG allows the user to select from two options for viewing the results The SNR graph view Display 6 shows the signal to noise ratio for each DP test frequency or TE test band The Value graph view Display 7 shows the absolute emission and noise levels for each DP test frequency or TE test band For additional information review the section nteroreting Results on page 30 Testing is complete when the green READY light is illuminated Both the tester and patient should remain as still and quiet as possible until the green light turns on NOTE The AUP arrow key can be used to abort a test in progress No record of an aborted test will be saved in memory 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 This screen again indicates the test ear and fur
67. re to the EROeSCAN a warning is provided that data will be deleted e Data can be deleted using the Clear function in the System Menu page 37 Data can be deleted in the EROeSCAN from the Database Software when the device is connected to the PC and EROeSCANS Database Software is opened When Names is selected the window allows data to be deleted via the Clear Instrument button See the EROeSCAN Database Software Manual tor further instruction 11 3 Printing to a Thermal Printer Printing to an optional thermal printer is by way of Bluetooth9 connection First establish Bluetooth pairing between the CONNECT TO EROeSCAN instrument and the printer by following the PRI 34 S1 instructions in the section nstrument Settings Bluetooth Device lt CONNECT gt Pairing on page 36 wv MainMenu NOTE See the printer operating manual for instructions on using Display 9 the printer or chapter MPT SANIBEL Mobile Thermal mini printer Following instructions provided with your printer be sure the printer is on and ready for communication printing From the EROeSCAN instrument Main Menu Display 1 page 18 press the AUP button to enter the device connection screen Display 9 Press the CONNECT button 24 8106286 Rev A ERO SCAN Operating Instruction The EROeSCAN will search for the paired printer showing Display 10 while searching When the printer is found all the test results PLEASE that are stored in mem
68. ry charging and communication with PC based database programs or an optional printer HDMI Connector for connection to the Micro Probe Integrated Bluetooth Class 2 EDR with SPP Protocol for communication with optional printer 52 8106286 Rev A M A ERO SCAN Operating Instruction MAICO POWER SUPPLY SPECIFICATIONS use only approved power supply Model No UEOSWCP 0501605SPA Output 5 0V 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 Operating Relative Humidity 30 to 90 non condensing Maximum Operating Altitude 2000 meters 6000 feet Transport and Storage 5 C to 40 C adi Fto 104 F Temperature y rf 53 8106286 Rev A M A ERO SCAN Operating Instruction MAICO Appendix A Flowcharts A 1 Test Operation Flowchart onse J CONNECT TO Press DOWN Arrow PRI 393 17 for 1 Second lt CONNECT gt MainMenu PROBE CHECK PROBE CHECK PROTOCOL DP 4s lt CHANGE gt w SETUP TESI TESI w REVIEW w REVIEW 54 8106286 Rev A MAICO A 2 Setup Menu Flowchart DATE TIME MENU 2 0 MAR 14 12 234 SETUP CHANGE Month lt MAR gt w NEXT Minute amp 43 gt wv DONE A teal DOWN arrow VAS represents the availability of an alternative menu When displayed press the DOWN arrow for three seconds to access t
69. s and or technicians neonatal nurses and school nurses who have been trained by a hearing healthcare professional 2 8106286 Rev A M A ERO SCAN Operating Instruction MAICO 3 Warnings Cautions and Errors In this manual the following two labels identify potentially dangerous or destructive conditions and procedures WARNING The WARNING label identifies conditions or practices that may present danger to the patient and or user CAUTION The CAUTION label identifies conditions or practices that could result in damage to the equipment NOTE Notes help you identify areas of possible confusion and avoid potential problems during system operation charged using only the provided power supply Injury to personnel or damage to equipment can result when a three prong to two prong adaptor is connected between the EROeSCAN power supply and an AC outlet nes The EROeSCAN Otoacoustic Emission Test System should be No moditications of the equipment are allowed by anyone other than a qualified MAICO representative Modification of the equipment could be hazardous The EROeSCAN product has been verified by an independent laboratory to conform to international standards for EMC electromagnetic emissions and immunity The user is advised to avoid installation and use of this instrument in proximity with other devices or equipment that may emit or be susceptible to electromagnetic interference including mobile phones If th
70. should be at levels characteristic of a typical location in a typical commercial or hospital environment 8106286 Rev A M A ERO SCAN Operating Instruction MAICO Guidance and Manufacturer s Declaration Electromagnetic Immunity The EROeSCANS is intended for use in the electromagnetic environment specified below The customer or the user of the EROeSCANS should assure that it is used in such an environment Immunity Test IEC 60601 Test Electromagnetic Environment Guidance Level Portable and mobile RF communications Conducted RF 3 Vrms 150 kHz 3 Vrms equipment should be used no closer to any part IEC 61000 4 6 to 80 MHz of the EROeSCAN including cables than the recommended separation distance calculated Radiated RF 3 V m 80 MHz to 3 V m from the equation applicable to the frequency of IEC 61000 4 3 2 5 GHz the transmitter Recommended separation distance d 1 17VP d 1 17VP 80 MHz to 800 MHz d 1 17VP 800 MHz to 2 5 GHz where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended 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 Interference may occur in the vicinity of equipment marked ta Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 Th
71. sults of completed tests in the non volatile memory meaning tests are saved even if the battery is temporarily discharged However the EROeSCANS is not intended for long term storage of test results NOTE Users are strongly encouraged to print transfer all test results at the completion of testing to avoid potential loss of data When operating in the default Save L R mode the EROeSCANS instrument will save the most recent test results for each ear and print transfer only these results This allows the user to retest a patient after a REFER result and to print transfer only the most recent test result for each ear It is recommended that the results be printed after each patient in the default mode When operating in the Save 250 mode the EROeSCANS will save up to 250 tests There are two options in the Save 250 mode 1 The EROeSCAN will automatically number each test from 1 to 250 This allows the user to save all tests for each patient tests of the same ear are NOT overwritten and to test multiple patients before printing or transferring results In this mode it is important to keep a record of the test number s for each patient 2 The EROeSCAN Database Software is used to transfer patient names to the EROeSCAN and the EROeSCAN will display the names When patient names are used patient names are uploaded from the ERO eSCANS Database Software to the EROeSCAN unit the patient names are displayed on the EROeSCAN Uni
72. t in the same order as displayed on the Database Software To move to a different name than the one displayed on the EROeSCAN screen use the LEFT or RIGHT arrows to cycle through the names until the desired name is on the display A patient named Unnamed is always included at the beginning of the EROeSCANS list for instances when a patient is being tested but the patient name was not transferred to the EROeSCAN The Unnamed selection can be used multiple times when transferring to the Database Software See nstrument Settings Save Mode on page 38 for information on changing the save mode settings 23 8106286 Rev A M A ERO SCAN Operating Instruction MAICO 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 EROeSCAN Database Software Data can be deleted through a few methods depending on the Save mode Save L R Mode e A single test for the Left ear and a single test for the Right ear are held in memory Data is deleted when a new test for the left or right ear is acquired NOTE Following printing or data transfer to the PC software all tests saved in memory are marked for deletion and will be permanently deleted when a new test is started It is not necessary to manually clear the results Save 250 Mode e Data is deleted when new Patient Names are uploaded from the Database Softwa
73. the EE NEN Uem selected protocol The open blocks indicate the noise floor in dB SPL 10 The solid blocks indicate the emission level in dB SPL Aga 11 The frequency band center F 8 4 0 6 19 13 12 The level of the emission in dB SPL TE 13 14 5 0 5 n 5 0 O F TE NF SNR F TE NF SNR The noise floor in dB SPL NF Figure 14 The signal to noise ratio SNR TE NF 33 8106286 Rev A M A ERO SCAN Operating Instruction MAICO 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 This approach is used to preserve the full precision of the test results but can result in some apparent errors in the printout due to the effects of rounding In the printout example above assume the actual values at 1 5 kHz were TE 4 5 dB NF 0 4 dB which results in SNR 4 9 dB The printout values are rounded up to the nearest integer and are shown as TE 2 5 NF 0 and SNR 5 This can result in what appears to be an error with regard to the pass criterion If the pass criterion is 5 dB while the actual SNR 4 9 the printed value will be 5 but a P will NOT be printed Again the pass refer criterion is based on the full precision of the results and not the rounded values that are printed The
74. the requirement This requirement is used in combination with the number of frequencies discussed below to determine an overall PASS REFER for each test Press the CHANGE keys to select an option and the YNEXT key to exit Display 35 45 8106286 Rev A M MAICO ERO SCAN Operating Instruction 19 4 Setting the Number of Frequencies for PASS 3 FREQS FOR PASS lt CHANGE gt w NEXT Display 36 19 5 Reset Protocol RESET PROTOCOL 6 RESET rc w NEXT Display 37 19 6 Save Protocol SAVE PROTOCOL SAVE gt v DONE Display 38 The number of frequencies for determining a PASS can be set from O 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 For example if the PASS SNR is set to 4 dB and the number of frequencies for PASS is set to 3 then the test must contain at least 3 frequencies where the emission is at least 4 dB above the noise to indicate a PASS Press the CHANGE keys to select an option and the YNEXT key to exit Display 36 NOTE Diagnostic protocols display the SNR graph with purple bars Once the Number of Frequencies for PASS is set above zero green bars display to identify this setting Selecting the RESET arrow key in the Reset Protocol menu Display 37 will return the selected protocol settings to their origi
75. ther gives the results of the test e PASS on the screen indicates that the patient passed the screening e REFER indicates that the patient did not pass the screening e NOISY indicates that excessive noise was present during the test 20 8106286 Rev A M A ERO SCAN Operating Instruction MAICO e NO SEAL indicates that a seal was not maintained throughout the test e FIT ERR indicates inadequate probe placement in the ear canal to produce target stimulus intensities When the test result is NOISY NO SEAL or FIT ERR the tester should reposition the probe selecting a different size eartip if necessary and 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 WDOWN arrow key to return to the graph After reviewing the results again push the WDOWN arrow key to return to the Main Menu Display 1 page 18 NOTE Completed tests are automatically saved By default Save L R Mode the EROeSCAN instrument will save only the last test for each ear Starting a new test for the same ear will overwrite the existing test NOTE Once the review screen is exited results are no longer viewable within the device Printing or transferring to the PC is required for continued viewing options See the next section Managing Results on page 23 for more information on how the EROeSCANS saves results See the section
76. this message is shown The user should set the correct date time Indicator LEDs lights NOISE Orange TEST Yellow READY Green CHARGE Blue The indicator labeled NOISE provides a visual indication AMBER that the noise level measured during the test exceeds a nominal threshold Also used to indicate some error conditions and when the outcome of test is REFER NOISY or NO SEAL The indicator labeled TEST provides a visual indication YELLOW that the selected test is being performed This indicator will remain on steady state during the test function The indicator labeled READY lets the user know that the instrument is not currently performing a test function and that it is available to perform a test function The indicator labeled CHARGE provides a visual indication BLUE of the battery recharging function and battery status The rate of illumination of the indicator provides a means of identifying the status of the charging function D 8106286 Rev A M A ERO SCAN Operating Instruction MAICO 4 Customer Responsibility WARNING This product and its components will perform reliably only when VAN operated and maintained in accordance with the instructions contained in this manual accompanying labels and or inserts A detective 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 w
77. to the infection control guidelines of the user s facility The disinfection materials and procedures applied in the users facility may be more appropriate for their circumstances than the methods outlined above see cautions below The frequency of cleaning and disinfecting is dependent on the facility s risk assessment usage and test environment Important e Do not immerse the instrument or probe in fluids or attempt to sterilize the instrument or any of its accessories Do not allow any fluid to enter the device Do not use autoclave sterilization Do not use alcohol based disinfectants Take care not to put excessive pressure on the clear display window or allow any utensil to puncture the display window or control panel NOTE Long term exposure to any disinfecting agents has the potential to alter the material properties of the plastic housing and labeling of the device Always follow the safety and disposal guidelines given by the manufacturer of cleaning and disinfectant chemicals 47 8106286 Rev A M A ERO SCAN Operating Instruction MAICO 20 2 Maintenance This instrument requires no regular maintenance beyond routine cleaning and annual calibration The probe tube requires replacement only when it becomes clogged A defective 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 cont
78. w NEXT Display 27 M A ERO SCAN Operating Instruction 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 WV NEXT to exit this menu The Reset to Default menu Display 27 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 WNEXT to return to the Main Menu NOTE This will un pair the Bluetooth9 device clear the test results and reset ALL system and protocol settings 40 8106286 Rev A M A ERO SCAN Operating Instruction MAICO 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 menus permit modification of the test parameters and pass criterion for the customizable DP protocols Changes to the protocol should be made only by qualified personnel 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 The EROeSCANS instrument comes with

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ERO•SCAN® Operating Instruction