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ERO•SCAN® Operating Instruction

1. M A ERO SCAN Operating Instruction MAICO MUP button to enter the device connection screen Display 10 Press the CONNECT button n The EROeSCAN will search for the paired printer showing Display PLEASE 11 while searching When the printer is found all the test results LIMIT T that are stored in memory will print out automatically bda The ERO SCAN instrument will power off when printing is CANCEL complete i d Display 11 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 11 3Connecting to the PC Database Software Connection to the PC database software is achieved by using the provided Micro USB to USB A cable 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 EROeSCANS instrument will detect the connection to the PC and wait for an action or communication from the PC database software NOTE See the EROeSCAN Database Software Manual for instructions on using the application 24 8105730 Rev B MAICO M A ERO SCAN Operating Instruction 12 MPT II SANIBEL Mobile thermal m
2. During instrument operation the user is warned of a low battery condition by the following illumination of the CHARGE indicator e wo fast blinks followed by a pause and then repeated until the battery is charged 9 3 Installing the Micro Probe Turn off the EROeSCAN and insert the Micro Probe connector into the socket on the top of the EROeSCAN Figure 3 The plug will fit in only one direction The MAICO logo will align with the instrument control panel NOTE Misalignment of the plug and socket can cause damage Figure 3 The plug and socket should be visually inspected prior to each installation of the remote probe If damage is observed contact MAICO Diagnostic 15 8105730 Rev B MAICO 9 4 Attaching Eartips i Figure 4 Figure 5 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 inserting 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
3. example PRT 00 df 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 NvMain Menu to exit the Bluetooth pairing menu NOTE See the Troubleshooting section on page 45 if Bluetooth pairing is unsuccessful or if any error messages are displayed 33 8105730 Rev B MAICO M A ERO SCAN Operating Instruction 16 2 Clearing Test Results f l2 TEST RESULTS CLEAR HEST Display 19 The Test Results Clear menu Display 19 allows the user to clear the test results stored in the unit without printing them Select the LEFT or RIGHT arrow key to clear the results and select Yes or No to verify clearing or to cancel To advance to the next menu without clearing the results press NEXT 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 16 3 Auto Shutdown Time i MINUTE CHANGE NEXT Display 20 POWER OFF The Power Off menu Display 20 refers to the Auto Shutdown time which controls how long the EROeSCAN instrument waits before s
4. HEAT Display 14 Display 15 If either the date or time is incorrect press the CHANGE key to access the menu to change the month Display 14 Press the LEFT or RIGHTD keys to scroll forward or backward through the months You will see the abbreviated name for each month Display 14 When the desired month appears on the display press the NEXT key to enter the day selection screen Pressing the LEFT or RIGHT keys will scroll through the days of the month After the correct day is selected press the NEXT key to enter the day selection display Again use the LEFT or RIGHT arrow keys to set the correct day Repeat this process for the year hour and minute using the LEFT or RIGHT arrow keys to make the selection and the NVNEXT key to advance to the next display When the correct minute is selected pressing the DOWN arrow key Display 15 will return to the Main Menu The time and date changes are automatically saved 32 8105730 Rev B MAICO M A ERO SCAN Operating Instruction 16Instrument Settings The EROeSCANS instrument allows the user to change many of the instrument s settings or functions These settings include Bluetooth9 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 CHANGE at the main menu Display 2 and then press V
5. Press the CHANGE keys to select an option and the NVNEXT key to exit Display 29 17 6 Reset Protocol RESET PEDTOCUOL T RESET HEAT Display 30 17 7 Save Protocol CL cvi PROTOLUL SHY DOME Display 31 Selecting the RESETD arrow key in the Reset Protocol menu Display 30 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 lt SAVE gt keys Display 31 Press the NVDONE key to exit 39 8105730 Rev B M A ERO SCAN Operating Instruction MAICO 18 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 19 The Advanced Options menu permits modification of the test stimuli and measurement values for the TE Custom Protocol 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 pre pr
6. from memory 34 8105730 Rev B M MAICO ERO SCAN Operating Instruction 16 5 Minimum Amplitude MIM VALUE Lil LDHHMGE HEST i Display 22 The Minimum Amplitude setting allows the user to set the unit to include minimum amplitude values in the pass refer criterion Display 22 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 The EROeSCANS is set with this feature turned OFF when it is shipped from the factory To change the mode to Minimum Amplitude setting press the LEFT or RIGHT arrow keys to select ON or OFF Once you have made your selection press NEXT The minimum DP amplitude is 5 dB SPL The minimum TE amplitude is 10 dB SPL 16 6Clock Mode LOE MOLE a HOUR LHHMGE HEAT Display 23 16 7 Language LANGUAGE EHGL EH CHANGE HEXT Display 24 The Clock Mode menu Display 23 allows the user to change the clock trom a 24 hour mode to a 12 hour mode To change the clock mode press the CHANGED keys Press the WNEXT to exit this menu The Language setting Display 24 allows the user to select among several languages To change the language press the
7. r considered a PASS at that frequency The limits for the PASS SNR HRHH E are 3 dB to 10 dB Pressing the LEFT or RIGHTD arrow keys will MEST increase or decrease the requirement This requirement is used in combination with the number of frequencies discussed below to Display 28 determine an overall PASS REFER for each test Press the CHANGE keys to select an option and the NVNEXT key to exit Display 28 38 8105730 Rev B M MAICO ERO SCAN Operating Instruction 17 5Setting the Number of Frequencies for PASS d FREDL FOUR LEZ CHANGE HEW Display 29 The number of frequencies required 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 Display 28 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 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
8. 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 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 Ero Scan is used exceeds the applicable RF compliance level above the Ero Scan 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 Scan b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 61 8105730 Rev B Specifications are subject to change without notice MAICO MAICO Diagnostic 7625 Golden Triangle Drive Eden Prairie MN 55344 Tel 888 941 4201 Fax 952 278 4481 E mail info maico diagnostics com Internet www maico diagnostics com 8105730 Rev B 3 14 D 0103992
9. 19 13 12 The level of the emission in dB SPL TE 13 The noise floor in dB SPL NF Figure 14 14 The signal to noise ratio SNR 2 TE NF 30 8105730 Rev B M A ERO SCAN Operating Instruction MAICO 14 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 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 full precision value for the SNR must be equal to or greater than the pass criterion b 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 d
10. America MAICO Diagnostic 7625 Golden Triangle Drive Eden Prairie MN 55344 Tel 888 941 4201 Fax 952 278 4481 E mail info maico diagnostics com Internet www maico diagnostics com Batteries may explode or cause burns if disassembled crushed or exposed WARNING A to fire or high temperatures 9 8105730 Rev B M A ERO SCAN Operating Instruction MAICO 7 Regulatory Symbols Symbol 980 amp 60601 1 Serial Number ow 980 amp 60601 1 Date of Manufacture X 980 amp 60601 1 TE A Caution Consult Accompanying 980 8 60601 1 Documents Return to Authorized Representative Special Disposal Required Reference Number B Patient Applied Part According to IEC60601 1 980 8 60601 1 Consult Operating Instructions 60601 1 Transport and Storage Temperature range EC REP 980 amp 60601 1 a Conforms to European Medical Device 10 8105730 Rev B 60601 1 EU Authorized Representative M MAICO ERO SCAN Operating Instruction KE A A MEDICAL GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI AAMI ES60601 1 2005 3rd ed and F359876 CAN CSA C22 2 No 60601 1 2008 11 8105730 Rev B 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 Emis
11. Refer servicing to A qualified personnel Do not touch the contacts on the bottom of the instrument and the patient at the same time Do not connected 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 14 5 4 Warning Explosion WARNING This system is not explosion proof Do not use in the presence of A 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 Proper use of this device depends on careful reading of all instructions 8 8105730 Rev B M A ERO SCAN Operating Instruction MAICO 6 Recycling Disposal Many local laws and regulations require special procedures to recycle or dispose of X electrical equipment related waste including batteries printed circuit boards electronic components wiring and other elements of electronic devices Follow all mm w your respective local laws and regulations for the proper disposal of batteries and any other parts of this system Below is the contact address for proper return or disposal of electronic wastes relating to MAICO products in North and South
12. 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 4 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 5 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 tor further information 16 8105730 Rev B MAICO M A ERO SCAN Operating Instruction 10 Operating Instructions 10 1 Preparing the Patient for Testing Otoscopic examination of the patient s ear canals should be performed prior to testing Excessive cerumen or vernix in the ear canals may interfere with the test and give invalid or incomplete results Patients with excessive cerumen debris or foreign bodies in the ear canals should be referred to a qualified professional for removal of the blockage prior to testing 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 bedd
13. 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 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 54 8105730 Rev B 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 etwi BINOMIAL DIST 70 E ki ONE IN TEN 60 ki 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 e DISTRIBUTION CUM DIST 1 FREQ 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
14. listed as meeting the requirements of the UL Medical and Dental Equipment Standard Connection of accessories not meeting these requirements may result in electrical leakage currents in excess of those allowed by the standard and present a potential electrical shock hazard to the person being tested E359876 This icon indicates that patient applied parts of the instrument contorm to IEC 60601 1 2005 Type B requirements Any program aimed at obtaining reliable measurements of otoacoustic emissions should be staffed and supervised by appropriately trained individuals 4 8105730 Rev B 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 of 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 Bluetooth 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 i
15. 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 43 8105730 Rev B M A ERO SCAN Operating Instruction MAICO 19 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 contaminated should be replaced immediately with clean genuine replacement parts manufactured by or available from MAICO Equipment is not user repairable Repairs and battery replacement must be performed by a qualified service representative only 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 19 3Probe 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 t
16. 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 2 keys to select an option and the NEXT key to exit Display 34 41 8105730 Rev B M MAICO 18 5 Reset Protocol EET Sesso soe Son PROTOCOL Display 35 18 6 Save Protocol de 2HVE PROTOLUL SPE DONE wets Display 36 ERO SCAN Operating Instruction Selecting the RESETD arrow key in the Reset Protocol menu Display 35 will return the selected protocol settings to their original factory settings Press the NEXT 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 lt SAVE gt keys Display 36 Press the VDONE key to exit 42 8105730 Rev B M A ERO SCAN Operating Instruction MAICO 19Cleaning and Maintenance 19 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 contaminat
17. ty tw ik fl ake ak kk kek l ka kk a pa a ka ak a E a kk e pet a n 12 8 1 How Does the ERO SCAN Device Work ccssssssssesssssesesesesesesesesesesescscevsvevevevevavavavavacavacacacaesesseees 12 8 2 How are the Results Stored and Reported Mh E kk eee nennen nnns 13 8 3 Sept Sid SDOEITIEILU Dt m ronu rn_n_n_ _ ooO_ _ o gt gg I HHH PPP MU22 jj 13 9 SETUD 14 9 1 LTA SC NS EEE LENN AES PE ab at bo it ia eave oon kk en PENE EE EENE d e ie ei O TEE 14 9 2 Bate CAG INNS r apwe tin elit lk e e at i bene at a neve er kn e e ao oka e e kou data SER ciini 14 9 3 installing the Micro PrOD DD NN Mna3D ft ei pk tt ki a AAS 15 9 4 ACAMEE gale Nt 16 10 Operating Instructions s w te ri ti ki dik ak at a kk tw ata a na ak l kk a ak fk AA k IG kal KA A a A AA 17 10 4 Prepanne the Patient TON O S LLA3 i kt et ki in a a e a naj ot ak ka e aa a KA N ak ke take WR Kab ta be 17 10 2 T rnine ts Inst FUR SA kisa ia ip a ta kisal e e n n ie n kn ki a e n nor kek e on ent 17 8105730 Rev B ERO SCAN Operating Instruction MAICO PGES COTO EIN ane foi io ti pa ia es pi tp e b n e td ba ei pan b e pet raz rrr da ko k 18 TOA W TIN NET VA sait ils E e e e ka eee ks e ot eee ka on in Dan 18 wS Selects the Test FA COCO zet kit ossi da kosa a aka a ko lott ie Xa n ki nye ek aj ae n ee asan 19 10 6 JAutoStart Beginning d Test silk ol
18. B 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 31 8105730 Rev B MAICO 15 Clock Settings EE ais is ERR UE Display 12 M A ERO SCAN Operating Instruction When the EROeSCAN 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 month day year e g Feb 28 12 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 Display 12 may appear If this message appears reset the time and date 15 1 Accessing the clock menu CHRHGE Display 13 To change the time and date press CHANGE at the main menu Display 2 and then press WSETUP at the protocol selection display Display 3 The current date and time presently set in the unit will be shown Display 13 If the time and date are correct press the MUP key to escape back to the main menu 15 2 Changing the Date Time ses Pir BIK
19. CHANGE keys until the desired language is shown Press V NEXT to exit this menu 35 8105730 Rev B M A ERO SCAN Operating Instruction MAICO 16 8Reset to Default The Reset to Default menu Display 25 will return all instrument pror qoe settings and protocol settings to their original factory defaults DEFAULT Select the lt LEFT or RIGHT arrow keys to reset and select YES amp BREE Pb or NO2 to verify reset To exit the System menu without resetting D HE the instrument press N NEXT to return to the Main Menu Display 25 NOTE This will unpair the Bluetooth device clear the test results and reset ALL system and protocol settings 36 8105730 Rev B M A ERO SCAN Operating Instruction MAICO 17 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 19 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 pre programmed protocol sett
20. Ero Scan be powered from an uninterrupted power supply Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment 8105730 Rev B M A ERO SCAN Operating Instruction MAICO Guidance and Manufacturer s Declaration Electromagnetic Immunity The Ero Scan is intended for use in the electromagnetic environment specified below The customer or the user of the Ero Scan should assure that it is used in such an environment Immunity Test IEC 60601 Test Electromagnetic Environment Guidance Level Portable and mobile RF communications Conducted RF 3 Vrms 150 kHz equipment should be used no closer to any part IEC 61000 4 6 to 80 MHz of the Ero Scan including cables than the recommended separation distance calculated Radiated RF 3 V m 80 MHz to from the equation applicable to the frequency of IEC 61000 4 3 2 5 GHz the transmitter Recommended separation distance d 1 17NP 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 A Note
21. Evoked Otoacoustic Emissions TEOAE Screener version DPOAE 2 0 kHz to 5 0 kHz TEOAE 1 5 kHz to 4 0 kHz Diagnostic version DPOAE 1 5 kHz to 12 0 kHz TEOAE 0 7 kHz to 4 0 kHz 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 Q 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 X1 23 X 5 78 In Instrument Weight 180 g 6 4 oz Liquid Crystal Display to provide user information and progress of measurement 4 button keypad to control instrument functions Integrated USB communication capability for battery 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 48 8105730 Rev B M A ERO SCAN Operating Instruction MAICO POWER SUPPLY SPECIFICATIONS use only approved power supply Model No UEOSWCP 050160SPA Output 5 0V DC 1 6 A Input 100 V 240 V AC 50 Hz 60 Hz 400 mA ENVIRONMENTAL REQUIREMENTS Operating Temperature 159 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 ula F to 104 F Temperature
22. ION 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 3 8105730 Rev B M A ERO SCAN Operating Instruction MAICO 3 Warnings Cautions and Errors WARNING The EROeSCAN Otoacoustic Emission Test System should be A 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 No modifications of the equipment are allowed by anyone other than a qualified MAICO representative Modification of the equipment could be hazardous The EROeSCANS 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 the 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 35 5 N Instruments which bear the Underwriters Laboratories Inc label UL should be interconnected with accessories that have the proper electrical compatibility and are
23. Interruptions and Voltage Variations on Power Supply Lines IEC 61000 4 11 Power Frequency 50 60 Hz IEC 61000 4 8 IEC 60601 Test Level 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 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 UT gt 95 dip in UT for 5 sec Compliance 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 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 UT gt 95 dip in UT for 5 sec Note UT is the a c mains voltage prior to application of the test level 60 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 30 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 Ero Scan requires continued operation during power mains interruptions it is recommended that the
24. KK A Aa 50 Appendix B Test Sequence eeeeseeeseeeee eene KAK KAK KAK KAK RAA KAR KA A A 52 Appendix C Pass Refer Cri terl kk seen eene nnne 54 Appendix D Configurations and Test Protocols 57 Appendix E EMC Compatibility kk kk kk kk kk kk KAR 58 TT 8105730 Rev B M A ERO SCAN Operating Instruction MAICO Title EROeSCAN OAE Instrument Operating Instructions MAICO Diagnostic 7625 Golden Triangle Drive Eden Prairie MN 55344 Tel 888 941 4201 Fax 952 278 4481 E mail info maico diagnostics com Internet www maico diagnostics com EC REP CE MAICO Diagnostic GmbH Salzufer 13 14 10587 Berlin Germany Tel 49 30 70 71 46 50 Fax 49 30 70 71 46 99 E mail salesQmaico biz Internet www maico biz Copyright 2014 MAICO Diagnostic All rights reserved No part of this publication may be reproduced or transmitted in any form or by any means without the prior written permission of MAICO The information in this publication is proprietary to MAICO Compliance MAICO Diagnostic is an ISO 13485 certified corporation IV 8105730 Rev B 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 Da
25. M Maico Diagnostics Operating Instruction EROeSCAN MAICO Diagnostic 7625 Golden Triangle Drive e Eden Prairie MN e 55344 e Tel 888 941 4201 e Fax 952 903 4100 M A ERO SCAN Operating Instruction MAICO Table of Contents 1 Standards COMO NAN C s u tk ak kt n l ke a tk ya kapeka aran tk nek aa e n ak e 1 2 lll IY oa a n 2 2 1 mended USE b t ke E e at n bk a e k l et n kt a et e ee pt n of et nt ke ree 3 3 Warnings Cautions and Errors kesye bi kas k k Riot as exon abs aer ba punk A KA AKA 4 3 1 aE ME Dl ca err aw w zzuzkzuz Il CPUs ME e rrr 5 4 Customer RespolsiDIIL D cece ce tactus kk ta n eaten ene in e KK ce 6 5 Safety Precautions enpe aa an den cree kaka aka kk kk AKA KA AA KA AA KA A A KA A A KA A A KA A A KAR A an ni 7 5 1 Cautions GE M T P 7 5 2 Warning Electric Shock FI IZAPAS kapab aa ves kin kk Sei a E a a we a ik sedo kaa ERES 8 5 3 Wam ng In CASE ON ENTE NE Cy ss nun at lat n ai a en l a te pa e an a bana aka eo es 8 5 4 Wada adip de o S ON entere tis artis TONER 8 5 5 IN AKNE SAB CES FY SAO DD fd ad on e ai ei da a na l e dtan ei a e a a e n a ba bi fe M DER 8 5 6 YA AF aL LA GEN SAA li 4e itilite sa owa tel p t rap ea tl nt eki akt a ea an e sa a a e an e e a kb w a e e a e e MM UM rn 8 6 Ro VCINNG DIS P S A ouem ae e ot n e a cents EE 9 7 Regulatory SymbDOIS coerente ak ik en n e po n n fe KAK l n KK 10 B AA WOU WEA ON it it cet
26. Meni ERNEUT TEE 32 15 2 Changing the Dal TID l Are nae nn EA 32 16 Instrument Settings ai ti wii a tit kai aa n a at ke kk yan PR a KAK KAKA KAKA WAK AA KWA KAK WA AA 33 16 1 Bluetooth Device Pairing ccccccececsccesescecesescceccececeecscececaceececsceecscscevaceecersceesacsecevaceecavacesaceecevacen 33 U MEME ARIS OSE URN si seta a ale e ke epe pin bos ba 34 163 Auto SAUEGOWN TINO Dn E kisoi ka ob bl ie klan kte kata ine kt kob bot d ota bad detan ken 34 16 4 Save Modae Storiing Test RESURS skandal n bari kip a a laz ne a e n a l V an z ene er 34 165 Minimum AM PITO AE i Siy baka iya pat ked pad pan biw kaki dede m 35 ios CIOCH N OUE fe eres enema ener an ia ket ket e n t ko et a r e er er ee a Dr er pu e M 35 T 8105730 Rev B ERO SCAN Operating Instruction MAICO tO ENEI O e di kok 35 16e RECTO DO AU kise m 36 17 Advanced Options for DPOAE Testing eese 37 17 1 Instructions for Customizing a Test Protocol seeeesseeeeeeeennnennnen enema 37 17 2 Selecting the Level of Primary TONES ccccccccsssecccceseccccesececsesececeeececeenscceseusececeuaecesseneceesenneeetes 38 17 3 Setting the Averaging TIIl u i Phu ki ik bla ke pi etes SEP Fade quaeso pi rado ni ad s a dosie eer Obs i pube PEE qus 38 VA SOUS the PASS NR EBUBL nu nebst mE TIVI Io eta auc ONE EUM EEUU s
27. R 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 8105730 Rev B 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 e 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 Diagnostic 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 EROeSCAN instrument is powered by an integrated rechargeable lithium ion battery 1800 mAh providing 20 hours 1000 tests minimum of operation between full charging The battery status is indicated by the battery icon shown in the upper right corner of the Main Menu Display 2 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 Figure 2 NOTE e Battery life will v
28. RO 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 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 47 8105730 Rev B MAICO 21Specifications 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
29. SETUP at the Protocol Change Display 3 to enter the Clock menu Display 13 At the Clock menu hold down the CHANGE key for 3 seconds until the Ready light green LED turns off and release the key NOTE Releasing the key will access the menus to change the instrument settings 16 1 Bluetooth Device Pairing 7 MEL BT DELICE DISCOUER HEST Display 16 PRATSOSS CHANGE PAIR DISCOUERED Display 17 ET DEUICE FRIRED FRHTSLE S3 JIointieniu 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 DISCOVER2 to initiate discovery of available Bluetooth devices The EROeSCAN will search for available Bluetooth devices for approximately 15 seconds During this time the user will see the message Please Wait on the display and the yellow LED will flash Discovery can be canceled by pressing the CANCEL 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
30. SPL The level L1 will change in Er 1 dB increments by pushing the LEFT or RIGHTD arrow keys and EE e press NEXT to move to the L2 screen Display 26 LHHHGE de MERE TE Press the NVNEXT key to set the level of L2 as with L1 above Display 26 Display 26 17 3Setting the Averaging Time The Averaging Time can be changed to one of four settings The ERE EP IM Averaging Time will have a large impact on the time required to dead perform the test and on the signal to noise ratio SNR A 0 5 Tilik second average for 6 frequencies would produce a test in about 4 o DHHHLE ou seconds A 2 second average for 6 frequencies would produce a HEST test in about 14 seconds The possible settings for the Averaging J Time are as follows Display 27 0 5 sec 1 0 sec 2 0 sec or 4 0 sec Press the CHANGE keys to select an option and the NEXT key to exit Display 27 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 17 4Setting the PASS SNR Level In order to provide a PASS REFER determination for each test the PASS SNR must be set This number refers to the number of EE on decibels that the DPOAE signal must be above the noise to be SMR
31. TE Do not have several printers powered on and within range while searching It is possible to pair up to 8 instruments with one printer If more instruments are paired the oldest will be deleted 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 sa en ay e Thermal line dot print L e Printing width 48 mm 1 9 in e Resolution 8 dots mm 203 dots per in y dpi e Dots per line 384 dots ues Thermal paper Physical properties e Paper width 56mm 1 mm 2 2 in e Size 102 mm x 75 mm x 45 mm 4 02 0 04 in max 40 mm 1 6 in in x 2 95 in x 1 77 in W x L x H diameter e Weight 205 g including battery without paper Battery pack e 2 cell Li lon battery pack 7 4 V 1500 Environmental specifications mAh e Operational temperature range 10 C to 50 C 14 F to 122 F Power supply charger e Operational humidity range 20 to 85 e 12 V 1 AUE15WCP1 120125SPA e Maximum current consumption 0 5 A e Storage temperature range 20 C to See also Figure 11 70 C 4 F to 158 F 28 8105730 Rev B M A ERO SCAN Operating Instruction MAICO 13Interpreting 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 d
32. ain 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 EROeSCANS Instrument Establish Bluetooth pairing The printer is not responding to queries from 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 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 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 46 8105730 Rev B MM A E
33. ary 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 of the battery remains 14 8105730 Rev B M A ERO SCAN Operating Instruction MAICO 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 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 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
34. ator 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 8105730 Rev B M A ERO SCAN Operating Instruction MAICO 4 Customer Responsibility WARNING This product and its components will perform reliably only when A operated and maintained in accordance with the instructions contained in this manual accompanying labels and or inserts 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 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 certifi
35. c interferences by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Ero Scan 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 200 MHz to 2 5 GHz W d 1 17VP d 1 17VP d 2 23VP For transmitters rated at a maximum output power not listed above the recommended separation distance a 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 59 8105730 Rev B M MAICO ERO SCAN Operating Instruction Guidance and Manufacturer s Declaration Electromagnetic Immunity The Ero Scan is intended for use in the electromagnetic environment specified below The customer or the user of the Ero Scan should assure that it is used in such an environment Immunity Test Electrostatic Discharge ESD IEC 61000 4 2 Electrical Fast Transient Burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage Dips Short
36. 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 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 55 8105730 Rev B 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
37. distributor Insert battery as shown Figure 9 Figure 9 Push POWER BUTTON 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 me Green Power indicator will be lit if printer is MPTI 8MAICO powered by battery Figure 10 Figure 10 26 8105730 Rev B ERO SCAN Operating Instruction Indicators Green LED indicator Blue LED indicator Fast flash Charging Poweron A Battery nearly EHI Power On completed Charging Power Off completed Power ON battery Slow flash amp Slow flash 5 Out of paper Slow flash 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 Bluetooth devices A device called MPT II should occur in the list of devices When prompted enter password 1234 Finish pairing 2 8105730 Rev B M A ERO SCAN Operating Instruction MAICO NO
38. e ear canal Refit the eartip and or change the eartip probe tube as necessary Appropriate adjustments should be made until a decrease in these bars Is seen 19 8105730 Rev B HEL TE VL IFE Display 6 ERO SCAN Operating Instruction Fe For an adult the VOLUME bar will decrease to about half Display 5 For an infant or child the VOLUME bar will decrease further to the left Display 6 The NOISE bar will show a decrease from the original reading 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 lt LEFT or RIGHTD 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 10 7 Calibration and Test Phe SUE Display 7 Display 8 The EROeSCAN instrument will automatically perform a calibration at the start of each test Display 7 During calibration 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 auto
39. e UID RM e mea a p 38 17 5 Setting the Number of Frequencies for PASS ccccccsssccccessccccesececeeseccceeecceeeeseceseuaeceesensceeseneeeetas 39 1o dps gn 39 DAY DAVE PO OU BERE T Tm 39 18 Advanced Options for TEOAE Testing eese 40 18 1 Instructions for Customizing a Test PrOTOCO cccccceseccccessececeesececeeseceeceeeceeceusececeeaecessegeceeseeeeeetes 40 18 2 S leclihgihe AVE rele IMS TAN O n n eny yiy y n l n DU let a ia Monter dum sa ek et a a ee k E baba 41 18 3 Seinge HE PASS SNPCEBUB si ee an Oe eee 41 18 4 Setting the Number of Frequencies for PASS cccccceseccccssseccceesececeeseceeeeescceeeuseceseuaeceseeneceeseeneeeten 41 185 TRESS P OTOU lg 42 lee SANS PRORO CON ete toute ee ti bo bd taste bebe ont 42 19 Cleaning and Maintenance erus oro k ah kika sanke a di sis AA KAKA WW AA 43 191 Cleaning and DISINI GOL JO iy ie kaa it ante ko ya oi Dakak Ne k RRES 43 CS DD a at e 44 195 Prope Tube KEPI ICE ANE AN kre aa a ant ia kata as rt a kf tn kt e a a aa rr e pv et a e e pat kk ba e uo y g g 44 20 TFOUDIESNGO CAN Ye ik ak onn a a n al ese a tn n dual ease 45 21 SP ANCONS TTL n a n bk to pen anes 48 Appendix A FIOWONAN CS ei wete vin ott it mt it sp ok gn ko e e KK e KK CEU kak ef KK
40. e screen The screen will indicate which button to push by showing the appropriate arrow ERO SCAN NOTE The UP key will always bring the instrument back to either the previous menu or the main menu The MUP key will also access the print command trom the Main Menu w MAICO Figure 6 10 4Main Menu Selected Protocol Time Battery Status f L TEST R4 CHANGE Start Left Ear Test Start Right Ear Test Display 2 Change Protocol and Settings 18 8105730 Rev B MAICO M A ERO SCAN Operating Instruction 10 5Selecting the Test Protocol PROTOCOL LIF dz CHHHGE de ETI Display 3 The currently selected protocol is shown on the Main Menu Display 2 To change the selected protocol press CHANGE at the Main Menu The Change Protocol display will appear Display 3 Use the CHANGE arrow buttons to change the selected protocol Press the NUP arrow to return to the Main Menu to begin testing Press the WSETUP to enter the setup menus For either DPOAEs or TEOAEs screener devices there are two default test protocols that vary by averaging time Appendix D contains complete information on protocol settings NOTE Screener default protocols cannot be customized Diagnostic protocols are customizable 10 6 AutoStart Beginning a Test To obtain a seal and measure emiss
41. e 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 7 seconds A 16 second average would produce a test in about 18 seconds 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 32 18 3Setting the PASS SNR Level Display 33 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 GB Pressing the lt LEFT or RIGHTD 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 CHANGE2 keys to select an option and the NEXT key to exit Display 33 18 4Setting the Number of Frequencies for PASS 3 FREGS FOR PASS CHANGE amp HEXT Display 34 The number of frequencies for determining a PASS can be set from 0 to 6 If the setting is on 0 then no indication of PASS REFER will be made This
42. e the Ero Scan according to the EMC information presented on this page and the next 4 pages The Ero Scan has been tested for EMC emissions and immunity as a standalone instrument Do not use the Ero Scan 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 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 Requiremen
43. ed 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 EROeSCANS 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 3096 and 9096 non condensing A 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 8105730 Rev B M A ERO SCAN Operating 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 ap
44. he ear selected Right or Left 5 0 jinin 8 A PASS REFER indication if there is a criterion set for the pee am mon selected protocol w 9 The open blocks indicate the noise floor in dB SPL s l m E 10 The solid blocks indicate the emission level in dB SPL ET DE r yi fs 11 The f2 frequency in kHz Gen 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 13 3 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 U100 0 2 The time and date of the test based on the setting of the 17 JUN 13 15 33 003 TE 325 10 sec aug internal clock if the clock is set correctly this time and date SN nEI001003 ME2001005 will be correct The test number if operating in e g 001 Save 250 mode 4 The protocol selected e g TE 325 1 5 ooo 1 5 The averaging time used for this test e g 10 sec avg an pest 6 Instrument Probe serial number SN 3 0 lI 7 The ear selected Right or Left Y m 7 8 A PASS REFER indication if there is a criterion set for the NEL MN Umm selected protocol 9 The open blocks indicate the noise floor in dB SPL a ide T a esasi 10 The solid blocks indicate the emission level in dB SPL Lal 1 12 gae 11 The frequency band center F 2 5 9 17 8 4 0 6
45. hutting itself off after a period of inactivity It is not necessary to manually turn off the EROeSCAN unit The Automatic Shutdown feature is designed to prolong the battery life of the instrument when it is not in use By default the instrument automatically shuts off after 1 minute has elapsed The Auto Shutdown time may be increased or decreased by pressing the CHANGED keys The times available are 30 seconds 1 2 or 4 minutes Once you have made your selection press VNEXT 16 4Save Mode Storing Test Results SAVE LAR TESTS Loic HEAT CHANGE Display 21 The EROeSCANS unit automatically stores only the most recent test result for each ear L R Display 21 but has the capacity to store 250 individual tests To change the mode to save up to 250 tests press the LEFT or RIGHTD arrow keys to change the menu to 250 Once you have made your selection press NEXT It is recommended that you go to the Test Results Clear screen Display 19 to clear any previous memory test results 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
46. ing The patient should remain still and quiet while the test is being performed 10 2Turning On the Instrument Display 1 To turn on the EROeSCAN instrument press the NVDOWN key located below the instrument s display screen see Figure 6 The yellow 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 Display 1 will appear briefly This display will indicate the type of instrument Screener SCR Screener Plus SC Standard STD or Combo CMB software version and serial number for example ME1234567 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 2 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 page 32 If a time date error message is indicated follow the instructions in this section to set the correct date and time 17 8105730 Rev B M A ERO SCAN Operating Instruction MAICO 10 3 Control Panel The EROeSCANS instrument uses 4 buttons to control all functions of the instrument Figure 6 These buttons are arranged in a directional cursor format The arrows on the keypad LEFT RIGHT SUP and VDOWN correspond to the arrows that are used on th
47. ings 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 17 1 Instructions for Customizing a Test Protocol To enter the DPOAE Menu 1 Press CHANGE at the main menu Display 2 2 Using the CHANGED buttons select the DPOAE protocol you want to customize the DP 4s protocol is not customizable 3 Press VSETUP at the Protocol menu Display 3 4 At the Clock menu Display 13 hold down the YVCHANGE key tor 3 seconds until the Ready light green LED turns off 5 At the New BT Device menu Display 16 hold down the VCHANGE key for 3 seconds until the Ready light green LED turns off You will now see the Level L1 screen Display 26 You are in the DPOAE menu and will be able to scroll the available protocol parameters with the NVNEXT button and make changes by using the LEFT or RIGHTD arrow keys to CHANGE the selection NOTE If you push the DOWN arrow key without holding it for 3 seconds you will scroll through date and time etc rather than accessing the displays that allow you to make changes to the custom protocols 3 8105730 Rev B M A ERO SCAN Operating Instruction MAICO 17 2Selecting the Level of Primary Tones 3 The intensity of the primary tones L1 L2 may be changed to any LEVEL level between 40 dB SPL and 70 aB
48. ini printer Cautions General information MPT II printer kit includes RISK 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 25 8105730 Rev B 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
49. ion or if the test will not progress past the AutoStart 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 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
50. ions 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 RIGHTD arrow key to indicate which ear will be tested After the test ear is selected the AutoStart screen Display 4 will be shown This display shows two horizontal bar graphs representing the environmental noise NOISE and the ear canal volume VOLUME When both bars fill the screen from left to right the environmental noise is high and the ear canal volume is large The NOISE and VOLUME bar readings should be used as an indication that the unit is sealing the ear canal e f the VOLUME and NOISE bars are filling the screen the eartip is not sealing the ear canal Select a different size and reposition the eartip e f the NOISE bar is filling the screen VOLUME bar is reduced the patient may be too noisy or the probe fit is unstable moving too much Reduce patient noise by swaddling a baby distracting a child and reinstructing an adult e f the VOLUME bar is filling the screen NOISE bar is reduced the patient may have a PE tube or eardrum perforation Try bypassing AutoStart see note on page 20 e f the VOLUME bar is not visible at all the eartip may be blocked by cerumen wax or vernix or is resting against the wall of th
51. is noise but performing the testing in a relatively quiet environment is recommended 10 11 Turning Off the Instrument The EROeSCAN 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 DOWN key This feature can be re programmed for various periods of inactivity before shutdown See the Changing nstrument Settings Auto Shutdown Time on page 34 NOTE The UP arrow can be used to manually power off the instrument 22 8105730 Rev B 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 S 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 EROQeSCANP instrument automatically saves the results 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 EROeSCAN instrument will save the most recent test resul
52. isplay will be generated and shown during the test and can be reviewed after the test is complete The display might differ depending on the settings used for the test ER Each vertical ESI EHI EH T uai represents EH He E EE 2 dB SNR EH EEE HE EE HE HE X7 Frequency gt a deu A uns Q li Ez T a Q o Bum Q 2 Q z mila G amp 5 Bum Aa Each column represents an individual frequency Figure 12 The display shows a 6 column graph Figure 12 Each frequency DPOAEs or frequency band TEOAEs is indicated by one column Each row represents 2 dB of signal to noise ratio SNR For example if the column goes to the top of the display then the SNR is 12 dB or greater 6 rows of 2 dB each 29 8105730 Rev B M MAICO ERO SCAN Operating Instruction 13 2Understanding the DPOAE Printout The following information is provided for each test Figure 13 MIMAICO ERO SCANQAIE U100 01 17 JUN 13 15 27 001 P 45 4 sec avq SN ME1001003 ME2001005 1 The software version number e g V100 01 The time and date of the test based on the setting of the internal clock if the clock is set correctly this time and date will be correct The test number if operating in Save 250 mode eT ee e g 001 Left Pass 4 The protocol selected e g DP 4s 5 The averaging time used for this test e g 4 sec avg 2 0 nnnm 6 Instrument Probe serial number SN immu nm 7 T
53. matically During the test phase a set of bars should appear on the display Display 8 These are the test results which are displayed as the emissions are measured Each column represents one test frequency DP or frequency band TE Each row represents 2 dB of signal to noise ratio measured at each of the test frequencies or in each of the frequency bands Additional information is available in the section nterpreting Results on page 29 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 ANUP arrow key can be used to abort a test in progress No record of an aborted test will be saved in memory 20 8105730 Rev B M A ERO SCAN Operating Instruction MAICO 10 8 Viewing Results When testing is complete a display similar to Display 9 will appear i EFI EHE The results of the test are automatically saved in memory as soon be um um as the test is complete The results will be saved even if the unit TEST Ra turns off or the batteries are temporarily depleted This screen 2i m again indicates the test ear and further gives the results of the test 4ORBEVIEM Display 9 PASS on the screen indicates that the patient passed the screening REFER indicates that the patient did not pass the screening NOISY indicates that excessive noise was present during the te
54. ment 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 DOWN arrow button for 10 seconds to force the instrument to power off Powering the instrument back on again should reset restore normal function Contact MAICO for service if the problem persists 45 8105730 Rev B m MAICO BT Device Not Found BT 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 ag
55. 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 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 to appear while testing The light will appear intrequently 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 sounds 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 th
56. n 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 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 indic
57. ny 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 EROeSCAN Otoacoustic Emission Test System contact your Special Equipment Distributor or contact MAICO Diagnostic by phone at 888 941 4201 or by fax at 952 903 4100 2 8105730 Rev B M A ERO SCAN Operating Instruction MAICO 2 1 Intended Use The EROeSCAN 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 EROeSCAN 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 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 CAUT
58. oStart calibration and test phase The AutoStart phase determines when the calibration phase should proceed while the calibration phase calibrates the level of the tones that will be applied during the actual test phase Artifact rejection is employed during the test phase to reduce the effect of transient noise bursts Immediately after the test button is pressed the AutoStart phase of the test begins AutoStart 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 resol
59. ogrammed 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 18 1Instructions for Customizing a Test Protocol To enter the TEOAE Menu 1 Press CHANGE at the main menu Display 2 2 Using the CHANGE buttons select the TEOAE protocol you want to customize the TE 64s protocol is not customizable 3 Press VSETUP at the Protocol menu Display 3 4 At the Clock menu Display 13 hold down the CHANGE key for 3 seconds until the Ready light green LED turns Off 5 At the New BT Device menu Display 16 hold down the V CHANGE key for 3 seconds until the Ready light green LED turns off You will now see the Averaging Time screen Display 32 You are in the TEOAE menu and will be able to scroll the available protocol parameters with the NVNEXT button and make changes by using the lt LEFT or RIGHTD arrow keys to CHANGE the selection NOTE If you push the DOWN arrow key without holding it for 3 seconds you will scroll through date and time etc rather than accessing the displays that allow you to make changes to the custom protocols 40 8105730 Rev B MAICO M A ERO SCAN Operating Instruction 18 2Selecting the Averaging Time AVERAGING TINE 64 LHHHMGE d i4 bout i Display 32 The Averaging Time can be changed to one of fiv
60. plicable 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 EROeSCAN 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 A 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 Do not clean or reuse eartips 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 7 8105730 Rev B M A ERO SCAN Operating Instruction MAICO 5 2 Warning Electric Shock Hazards WARNING DO not open the case of the EROeSCAN Instrument
61. r 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 52 8105730 Rev B M A ERO SCAN Operating Instruction 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 53 8105730 Rev B 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 backgro
62. sions DPOAEs or Transient Evoked Otoacoustic Emissions TEOAEs at several frequencies The EROeSCANS is available as Screening or Diagnostic version Please see chapter 17 and 18 for further information 8 1 How Does the EROeSCAN Device Work Probe Connector Test Status Indicators Display OF SL TEST Re eCHANSE User Interface Buttons Charge Status Indicator Micro USB Connector Figure 1 The system consists of the instrument Micro Probe printer 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 a liquid crystal display LCD 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 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 ear
63. st NO SEAL indicates that a seal was not maintained throughout the test FT 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 DOWN arrow key to return to the bar graphs Display 9 After reviewing the results again push the DOWN arrow key to return to the Main Menu Display 2 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 See the next section Managing Results on page 23 for more information on how the EROeSCANS saves results and how to print or transfer those results to the PC database software See the section nstrument Settings Save Mode on page 34 for more information on the EROeSCAN save mode options 2 1 8105730 Rev B M A ERO SCAN Operating Instruction MAICO 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
64. taktik st ni ma ba ik je e ae lakin a ia kw be RW WO W kon ae We WEK 19 10 7 Calibration MET m mh 20 TQS NOMS MEER 21 iE EI Eee E 22 10 10 HOLE SOC SS T 22 10 11 CIES OI toe pst Pamela eden er tuba etus tirer l des cae kan a a bise vadum aede boz 22 11 Managing ROSUIES 21 505 aR UXOR RAUS CREE ades ud opas oes oR dum A eee ee 23 R aA IU RR uc 23 11 2 BALE tous Thermal Printer aussedieenmadisonuDaqaet Uu codici eti xela ben atu l on Reta ama do SU ONT S m Sent n 23 11 3 Connecting tothe PC Database SOItWOF G Ec k l eet ret ek Hi k y K k o ad Loi EN abe Ped RA Kal k n b l 24 12 MPT II SANIBEL Mobile thermal mini printer 25 Te OPETI c 26 13 Interpreung KE SU AS eon gg eee 29 13 1 Understanding the DEPI AN aw i452an seok nayan ued tb bet ndi ton tap e NI msie P eta paf e se a b aba a BAUR te 29 13 2 Understanding the DPOAE PFT LO eo at n pike pala bo kaj oak DU e a ak ka ak ka ae ke ed Kanta be 30 13 3 Understanding the TEOAE Printout evi nt tl ka a n ka rv kk anka l as e KEK a kara n 30 14 Rounding Results ui eti kot ot lp ne n l n e KAKA KA A KA KK A KK KK e n CE 31 13 CIOCK SOUNS cr tense pea pk n kaa e ke pe e kon 32 151 Accessing NE clock
65. te 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 8105730 Rev B M A ERO SCAN Operating Instruction MAICO 2 Warranty MAICO Diagnostic warrants that this product is free from 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 Diagnostic shall void this warranty MAICO Diagnostic shall not be liable for a
66. tips which fit onto the probe tube The disposable eartips are color coded to facilitate easy selection by size 12 8105730 Rev B 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 LCD 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 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 REFE
67. ts for Medical Electrical Systems 5 IEC EN 60601 1 2 Medical Electrical Equipment Part 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 58 8105730 Rev B M A ERO SCAN Operating Instruction MAICO Guidance and Manufacturer s Declaration Electromagnetic Emissions The Ero Scan is intended for use in the electromagnetic environment specified below The customer or the user of the Ero Scan should assure that it is used in such an environment Emissions Test Compliance Electromagnetic environment Guidance RF Emissions Group 1 The Ero Scan uses RF energy only for its internal CISPR 11 function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment The Ero Scan is suitable for use in all commercial CISPR 11 industrial business hospital and residential 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 Ero Scan 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 Ero Scan can help prevent electromagneti
68. ts 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 with each test being numbered 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 See nstrument Settings Save Mode on page 34 for information on changing the save mode settings 11 2 Printing to a Thermal Printer COMMECT TU Printing to an optional thermal printer is by way of Bluetooth9 FEHTaSLESS connection First establish Bluetooth pairing between the e DONNHECT ET ERO SCAN Instrument and the printer by following the uM He A instructions in the section nstrument Settings Bluetooth Device HALE Pairing on page 33 9 Display 10 NOTE See the printer operating manual for instructions on using 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 EROeSCANS instrument Main Menu Display 2 press the 23 8105730 Rev B
69. ube and twist slightly while pulling the probe tube straight out of the probe head Figure 15 Figure 15 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 16 A properly inserted probe tube will snap securely into place when it is fully seated in the probe head Figure 16 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 44 8105730 Rev B MAICO M A ERO SCAN Operating Instruction 20Troubleshooting 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 DOWN arrow must be pressed for a full second the Yellow LED will illuminate Connect the charger as shown in Figure 2 on page 14 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 NOISE and VOLUME bars during AUTOSTART Check that the instru
70. und 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 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 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 7 dB should also ensure less than 196 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
71. ution 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 sequence 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 pe
72. will indicate noisy PROBABILITY OF MISSING MOD SEVERE HL v 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 25 L O Lu 0 W 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 56 8105730 Rev B M A ERO SCAN Operating Instruction MAICO Appendix D Configurations and Test Protocols DPOAE Protocols Ser ten n ea wa FEN NEK Name Frea F2 Freq kHz L1 L2 Time SNR for Test Pass 5 0 5 0 5 0 dB Wr lel e 4 0 5 0 6 0 dB Nr Base Roe o 4 0 3 2 3 6 4 dB NT esas oe 8 0 6 3 7 1 8 dB peor o mowpp mro 12 0 8 0 10 0 dB 12 0 Diagnostic version also includes DP 4s screening protocol TEOAE Protocols L e AT m We Name Bands bands kHz Time max SNR for Test Pass 3 5 4 0 mr amm a_j 3 5 4 0 4 0 3 5 4 0 dB tr jr A e kako Ege 4 0 2 0 2 8 4 0 dB Diagnostic version also includes TE64s screening protocol Customizable fields 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 6 5 8105730 Rev B M A ERO SCAN Operating Instruction MAICO Appendix E EMC Compatibility Portable and Mobile RF communications equipment can affect the Ero Scan Install and operat
73. y ak 49 8105730 Rev B M MAICO ERO SCAN Operating Instruction Appendix A Flowcharts A 1 Test Operation Flowchart To Start Press DOWN Arrow for 1 Second COHHECT TO PRHTSO35 CONNECT T miri lar Up Arrow To Connect to BT Device T HOISE R LUME ESSA cae w OLDNE EBEBE CHANGE a j Up Arrow to Return CRL TEST TEST MODE HP CHANGE SETUP HOISE L LEFT EAR Poss L TEST R REVIEW EHE L TEST R REVIEM 50 8105730 Rev B A ERO SCAN Operating Instruction MAICO A 2 Setup Menu Flowchart DATE TIME SYSTEM DPOAE TEOAE MENU MENU MENU MENU PRESSURE L1 65 Setup CHANGE CHANGE HEXT Month 12 TEST PRESSURE Feb RESULTS L2 55 SHR CLEAR CHANGE 3 NEXT HEST NEXT POWER OFF j 3 FREQS 1 minute FOR PASS CHANGE NEXT SAVE PROTOCOL SAVE DOHE SAYE PROTOCOL yore UE LANGUAGE EMGLISH CHAHGE HEST NOTE DPOAE Menu and TEOAE Menu are not accessible in the EROeSCANS Screening version 51 8105730 Rev B M A ERO SCAN Operating Instruction MAICO Appendix B Test Sequence A complete test sequence consists of an Aut

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ERO•SCAN® Operating Instruction