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Operating Instructions   

 

 

 

 

 

 

 

1  Introduction 

 

The 

ERO•SCAN

® 

Pro test Instrument is indicated for testing cochlear and middle ear function in infants, 

children, and adults by measuring otoacoustic emissions (OAEs), tympanometry, and acoustic reflex  
(with optional external 

Tymp•OAE

  Probe

). The presence of otoacoustic emissions suggests normal 

outer hair cell function, which in turn correlates to normal hearing. The presence of a normal 
tympanogram suggests normal middle ear function and the presence of acoustic reflex responses at or 
below 95 dB HL indicates normal inner hair cell function.  
 
The 

ERO•SCAN 

Pro 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. 

1.1  Instrument Description 

What is the 

ERO•SCAN 

 Pro Instrument? 

The 

ERO•SCAN 

Pro test instrument consists of the handheld unit, external probe(s), printer, single-use 

eartips and other accessories. The 

ERO•SCAN

  Pro  instrument may be used as a screening tool, or in 

conjunction with conventional tests as part of a full diagnostic evaluation. 
 

The  ERO•SCAN

 

Pro  instrument contains the 

hardware and software for generating the test 
stimuli, measuring and displaying test  results, and 
storing the results until they are printed  or 
downloaded to the PC software. The plastic 
housing contains circuit boards that provide the 
signal processing and display the test results. The 
instrument also contains 4 AA/UM-3/R6 alkaline 
batteries to power the device. The instrument uses 
an organic LED  display (OLED) and light-emitting 
diodes (LEDs) to provide a visual display of test data 
and test conditions to the operator.  Two 
membrane-type push buttons and a 4-way 
navigation control located on the control panel  of 
the device allow the user to power the instrument 
on and off, control testing, and initiate printing. 
 
The probe sections  of the instrument and external 
probes house a microphone, two transducers, and 

two speaker tubes which produce test stimuli and measure the sound pressure level (SPL) present in the 
sealed ear canal. 

Additionally,  the  combined  Tymp•OAE  Probe™  contains  a  m

echanical pump system 

and pressure sensor to control and monitor air pressure variation in the ear canal.  Each probe houses a 
keypad with 

two buttons (right and left) which can be used to start a test with the probe.  LED’s on the 

probe keypad indicate ear being tested and test status. 
 
Interface of the instrument to the ear canal is accomplished through disposable eartips made of 
industrial elastomer, which fit onto the probe tip.  The disposable eartips are color coded to facilitate 
easy selection by size. 
 
How are the Results Stored and Reported? 
When the 

ERO•SCAN

  Pro  is set in its default settings, the instrument will store the results from one 

patient (most recent left and right ear  test for each available protocol) in its non-volatile memory for 

 

Summary of Contents for Ero Scan Pro

Page 1: ...Operating Instructions MAICO Diagnostics 10393 West 70th Street Eden Prairie MN 55344 USA Toll Free 888 941 4201...

Page 2: ...test 14 5 Understanding the Test Results 15 5 1 Understanding the OAE Results Display 15 5 2 Understanding the Tympanometry Results Display 16 5 3 Interpreting the Tympanometric test result 17 5 4 Abn...

Page 3: ...leaning and Disinfecting the Instrument 51 11 2 Maintenance Calibration 51 11 3 Probe Tip Replacement 51 12 Important Safety Precautions 52 12 1 Precautions 52 13 System Specifications 53 14 Warranty...

Page 4: ...lastic housing contains circuit boards that provide the signal processing and display the test results The instrument also contains 4 AA UM 3 R6 alkaline batteries to power the device The instrument u...

Page 5: ...air cell function or of hearing ability current research indicates that the majority of hearing impaired individuals can be identified by a simple OAE test Patients who fail to generate OAEs should be...

Page 6: ...he peak on the horizontal axis and on the vertical axis of the chart will provide diagnostic information regarding the function of the middle ear system Examples of normal and abnormal tympanograms ca...

Page 7: ...normal tympanogram curves is hatched Here you can see that the highest compliance is reached with normal pressure When you create positive and negative pressure the eardrum stiffens the compliance dec...

Page 8: ...cavity 1 Thermal Paper Printer with Lithium Ion battery installed with 1 Thermal printer paper roll 1 Printer charger 1 Printer data cable Note It is recommend that you save the box and packing materi...

Page 9: ...lose the battery compartment 3 Getting familiar with the ERO SCAN Pro Instrument 3 1 Controls and display Figure 1 Power Button Press to power on Press and hold to power off Info Button View detailed...

Page 10: ...to the ear canal Interface of the instrument to the ear canal is accomplished through disposable eartips made of industrial elastomer which fit onto the probe tip A disposable internal probe tip snap...

Page 11: ...a row of LED s above the left and right buttons The LED located between the left and right buttons indicates status of the probe Green Probe has been detected and instrument is ready to test Flashing...

Page 12: ...obe Disconnect and reinsert the connector if the status indicator on the probe is not illuminated or is yellow rather than green To return to using the internal probe of the handheld turn the instrume...

Page 13: ...obe is connected the pump will perform an initialization Do NOT insert the Tymp OAE Probe into the ear canal while the pump is performing this initialization The probe should be placed in the ear cana...

Page 14: ...with the ear canal opening The fit should be secure so that the probe will remain in the ear canal even with a light tug on the probe Caution must be taken however to ensure that the eartip does not e...

Page 15: ...e is positioned on the patient using the lanyard affixed to the back of the probe enclosure The lanyard is designed to be used as either a neck loop or a shirt clip Selecting the style for use will de...

Page 16: ...ll introduce noise into the measurement Common sources of noise are environmental room noise biological patient breathing moving talking chewing etc or physical probe movement AutoStart 1 Probe not in...

Page 17: ...tion regarding test results see section 5 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 t...

Page 18: ...for DPOAE and 4 dB for TEOAE A hashed block indicates that the SNR is less than these specified values Examples are shown in the display to the left This allows the user to judge the quality of the me...

Page 19: ...p and down arrow buttons to scroll through the details screen If any details are out of the viewable area select SHIFT to extend the viewable area of the display When finished viewing the details sele...

Page 20: ...eak compliance to the negative may occur with congestion and are rarely to the positive side Establish criteria for abnormal negative pressure when you become more familiar with using the equipment It...

Page 21: ...ir pressure while ear canal volume is normal Middle ear fluid such as in serious otitis media will yield a very flat tympanogram with no definite peak and negative air pressure A resolving case or beg...

Page 22: ...he stimulus type is followed by a yes no indication that the compliance change reached the selected criteria to consider the reflex present A compliance change meeting or exceeding the selected criter...

Page 23: ...right arrow button From the Review Results screen select Review Results using the right arrow button Review Results will display all tests saved in the instrument For each saved test the ear under tes...

Page 24: ...enu Deleting all tests To delete all saved tests select Show Results from the main menu From the Review Results screen use the up and down arrow buttons on the control panel to select Delete All and s...

Page 25: ...5 x 11 PC printer and customization of protocols and series See section 9 for more information on customizing protocols and series See Appendix A for software installation instructions Use the include...

Page 26: ...cting Preferences and then Printing Test Results from the menu Do not automatically print test results no action will be taken when he instrument in placed in the cradle Print test results to the defa...

Page 27: ...skip this step if no patient name is desired You will be prompted to save the file The software will suggest a file name or you may use a file name of your choice Click Cancel to abort the file save...

Page 28: ...s criteria has been met for the indicated frequency Signal to Noise Graph Vertical axis SNR dB Horizontal axis f2 frequency tested Hz Green bars indicate that the pass criteria have been met Red bars...

Page 29: ...50 of the peak Compliance displays the peak compliance Peak Pressure displays the pressure corresponding to peak compliance Graph Vertical relative canal volume ml indicated by the arrow and dynamic c...

Page 30: ...iteria Graphical table Each horizontal row shows the compliance changes for one stimulus type plotted as a function of stimulus intensity which is indicated in the header for each vertical column The...

Page 31: ...r supply is connected to the printer and an outlet The light on the face of the printer will illuminate solid green when the printer is powered up and ready to print A flashing green light indicates t...

Page 32: ...he button pressing and releasing the button twice in quick succession prints a demo test message showing the printer firmware version and settings 7 4 Connecting the cradle to the Printer Use the incl...

Page 33: ...and firmware version Patient number is indicated or a blank line is provided to write in the name See section 8 7 for information on using numbered patients The ear Right or Left and the test result P...

Page 34: ...using numbered patients The ear Right or Left and the test result Pass or Refer will be indicated on the printout Data Table F the frequency band P peak pressure level of the click stimulus TE the le...

Page 35: ...r Refer will be indicated on the printout Data table Frequency probe tone frequency 226 or 1 000 Hz Ear volume indicates the volume of the external ear canal Gradient indicates graph width in daPa val...

Page 36: ...ment serial number probe serial number and firmware version Patient number is indicated or a blank line is provided to write in the name See section 8 7 for information on using numbered patients The...

Page 37: ...anguages available will vary by instrument 8 2 Time Date To set the instrument time and date from the set up menu select the item showing the current date and time settings Use the right arrow button...

Page 38: ...s 8 5 DP Early Stop The user can select how the instrument will operate when performing a DPOAE test With the DP Early Stop feature off testing will be completed at all frequencies included in the sel...

Page 39: ...he test results are printed they are flagged for deletion and will be erased when a new test is completed The user can choose to enable the Numbered Patients feature When Numbered Patients are enabled...

Page 40: ...Patient Management software See Patient Management Manual 1162 0806 for more information 8 8 Sounds The ERO SCAN Pro provides audible feedback to the user to indicate when testing is complete To chang...

Page 41: ...e The authors of the referenced normative study Gorga et al 1997 suggest the 95th to 5th range as most accurately separating normal hearing and hearing impaired populations The Boys Town Norms templat...

Page 42: ...that run in sequence by pressing one button to begin the series Each ERO SCAN Pro comes preloaded with protocols and series 9 1 Creating Editing Protocol Files Protocol files originate on the computer...

Page 43: ...ing editing and managing protocol files saved on the computer These functions are View displays the settings and parameters for the selected protocol Create New begins the process to create a new DPOA...

Page 44: ...ssing frequencies for a test pass can be set to any value between 1 and 10 but cannot exceed the total number of frequencies tested F2 use the slider bars or type the numerical value into the text box...

Page 45: ...the first test frequency top row and then applied to all frequencies by clicking the Apply Values to All Frequencies button Creating or Modifying TEOAE Protocols To create a new protocol file click t...

Page 46: ...tween 8 and 64 seconds Evaluation Criteria check the box if a Pass or Refer outcome should be determined for this protocol Indicate the number of passing frequencies required for the overall test resu...

Page 47: ...evaluate Pass or Refer Setting the within limits box Minimum peak pressure for a pass selects the low pressure limit for the box 300 to 400 Maximum peak pressure for a pass selects the high pressure...

Page 48: ...and 4 but cannot exceed the total number of frequency bands tested Using the check boxes under the Reflex Stimulus column select up to 4 stimuli to be presented Using the check boxes 60 95 dBHL select...

Page 49: ...the Rename button located on the right panel of the protocol window Copying a Protocol File To copy a protocol select the protocol to be copied and click the Copy button located on the right panel of...

Page 50: ...he instrument Create New Series opens the Create New Series dialog shown in figure 85 Instructions for creating a new series of protocols can be found in section 9 3 of this manual Load opens the dire...

Page 51: ...g the new protocol file 9 3 Creating Series Protocol series are a sequence of individual protocols which are linked together A series can be composed of any combination of DPOAE TEOAE or Tympanometry...

Page 52: ...typically in your practice setting For example you may want to start with an OAE test and only proceed with the tympanometry test when there is a Refer outcome on the OAE test Another option might be...

Page 53: ...munication between instrument and computer Button on cradle is the printer position Check that the button on the cradle is the computer position down Cradle is not connected to the computer Check USB...

Page 54: ...o the right The tabs should audibly snap off the probe assembly Pull the probe tip directly off the probe and discard it Obtain a replacement probe tip and orient the tip with the arrows on the face o...

Page 55: ...s in this device do not mix battery types and do not mix old and new batteries Remove the batteries from the instrument if it will not be used for 4 weeks or more Do not immerse the unit in any fluids...

Page 56: ...FACT 10 dB SPL TYMPANOMETRY SYSTEM PROBE TONE Frequencies 226 Hz 1000 Hz Level 85 dB SPL with in ear calibration AIR PRESSURE Range 0 05cc to 3 0cc 300 to 400 daPa 3 0cc or greater at least 200 to 200...

Page 57: ...ven 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 MERCHANTABILI...

Page 58: ...SCAN Pro Software Installation Instructions 1 Application Installation To begin installation double click on the installer file EroscanPro_installer_user_p 120508 exe Then follow the steps as shown be...

Page 59: ...Operating Instructions 56 If the installed cradle driver is an older version it will be uninstalled and the new driver will be installed 7 8 9 10 11 12 13 14...

Page 60: ...ng Preferences and then Printing Test Results from the menu Do not automatically print test results no action will be taken when he instrument in placed in the cradle Print test results to the default...

Page 61: ...he desired information into the four text lines available in the Report Header dialog To add a custom logo to the report header use the Change button to set the path to a large or small logo file Fini...

Page 62: ...n Norms template on the DP Gram of the PDF or printed test report by selecting that option with Preferences Show Boys Town Norms Template with DP Graphs The Boys Town Norms template is explained in th...

Page 63: ...uickScreen Tymp 1000 Hz X X Infant TE TE QuickScreen Tymp 1000 Hz X X Screening DP Tymp 226 Hz Ipsi 1F 90 dB DP QuickScreen X X Screening TE Tymp 226 Hz Ipsi 1F 90 dB TE QuickScreen X X Infant DP DP Q...

Page 64: ...ing sure to keep any weight off the probe cable Although it is a matter of preference many users prefer to start the test prior to inserting the probe in the ear This allows the tester to focus on the...

Page 65: ...timulus 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...

Page 66: ...ents and in the ERO SCAN Pro 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 simil...

Page 67: ...ts vary considerably depending on subject population methodology and criteria for the study For example the reported limits for pressure can vary by 50 dapa and compliance limits can vary by 0 30 ml d...

Page 68: ...other actual data But in principle a Stapedial reflex indicates that the patient hears on the stimulus ear and that the sound lead on the probe ear functions It is for these reasons that acoustic ref...

Page 69: ...ndings in testing 8 children age 5 13 years and 12 adults age 50 78 years normal emissions to 12 kHz in children Figure 1 and no response above 8 or 10 kHz in older adults Figure 2 Although sufficient...

Page 70: ...Averaging the results of several DPOAE test improves the reliability compared to a single test This is particularly important when DPOAE test results are used to monitor changes in hearing sensitivity...

Page 71: ...e microphone in an OAE probe could occur at high frequencies In our own measurements we have seen occasional differences as large as 15 dB from the combination of wavelength effects and improper earti...

Page 72: ...ublishing Group Harris F P Lonsbury Martin B B Stagner A C Martin G K 1989 Acoustic distortion products in humans systematic changes in amplitude as a function of f2 f1 ratio Journal of the Acoustical...

Page 73: ...cations subject to change without notice MAICO Diagnostics 10393 West 70th Street Eden Prairie MN 55344 Tel 888 941 4201 Fax 952 278 4481 E mail info maico diagnostics com Internet www maico diagnosti...

Page 74: ...1162 0802 Rev E 05 12...

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