ERO.SCAN Pro Operating Instructions Rev A Jan 2012

Operating Instructions EROCSCAN Pro Table of Contents

Page

1. Introduction ... 1 1.1 1.2 1.3

Instrument Description ... 1 Otoacoustic Emissions ... 2 Tympanometry ... 3

2. Important Safety Precautions ... 5 2.1 2.2

Disclaimer ... 5 Precautions ... 6

3. Getting Started ... 8 3.1 2.2 2.3

Unpacking the system ... 8 Battery Installation ... 9 Environmental conditions ... 9

4. Getting familiar with the ERO•SCAN Pro ... 10 4.1 4.2 4.3

Controls and display ... 10 Internal Probe ... 10 External Probes (optional) ... 11

5. Conducting a Measurement ... 13 5.1 5.2 5.3 5.4 5.5 5.6 5.7

Quick Start ... 13 Powering on the Instrument ... 13 Selecting a Protocol or Protocol Series ... 14 Selecting an Eartip ... 14 Preparing the Patient ... 14 Conducting a measurement ... 15 Proceeding to the next test ... 18

6. Interpreting Results... 19 6.1 6.2 6.3 6.4

Understanding the OAE Results Display ... 19 Understanding the Tympanometry Results Display ... 19 Interpreting the Tympanometric test result ... 20 Abnormal Values ... 20

7. Managing Test Results ... 21 7.1 7.2

Reviewing Test Results ... 21 Deleting Test Results ... 22

8. Printing Test Results... 23 8.1 8.2 8.3 8.4 8.5

Connecting the cradle to a computer ... 23 Quick-Print to PDF or to the default PC printer ... 24 Thermal printer set up ... 28 Connecting the cradle to the Printer ... 30 Printing with the Thermal Paper Printer ... 30

9. Set Up ... 33 9.1 9.2 9.3 9.4 9.5 9.6 9.7 9.8 9.9 9.10

Language ... 33 Time/Date ... 33 Display Contrast ... 34 Instrument Details ... 34 DP Early Stop... 34 OAE Minimums ... 35 Save Mode (Patients) ... 35 Sounds ... 36 Graph Style ... 37 Reset ... 37

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Operating Instructions EROCSCAN Pro 10. Customizing Protocols and Series ... 38 10.1 10.2 10.3

Creating/Editing Protocol Files ... 38 Managing Protocols in the Instrument ... 45 Creating Series ... 47

11. Troubleshooting ... 50 12. Care and Maintenance ... 51 12.1 12.2 12.3

Cleaning and Disinfecting the Instrument ... 51 Maintenance & Calibration ... 51 Probe Tip Replacement ... 51

13. System Specifications... 53 14. Warranty, Maintenance and Service ... 54 15. Replacement Parts and Upgrades ... 55 16. Safety Regulations ... 56 Appendix A: ERO-SCAN Pro Software Installation Instructions ... 58 Appendix B: Default Test Protocols and Protocol Series ... 70 Appendix C: Test Technique and Sequence ... 75 Appendix D: Pass/Refer Criteria ... 77 Appendix E: High Frequency Measurements ... 79

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Operating Instructions EROCSCAN Pro 1. Introduction The ERO•SCAN™ Pro Test Instrument is designed to be a screening device for cochlear hearing loss and/or middle ear pathology (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. However, a passing result using this instrument is not an indication that the full auditory system is normal. Thus, a PASS result should not be allowed to override other indications that hearing is not normal. A full audiologic evaluation should be administered if concerns about hearing sensitivity persist. A REFER test result should not be assumed to be an indicator of a lack of auditory function or the presence of pathology; however, it should be followed with full audiologic diagnostic testing and/or medical evaluation as appropriate. Note: 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. 1.1 Instrument Description What is the ERO•SCAN Pro Instrument? The ERO•SCAN Pro test instrument is a hand-held device designed to provide an objective measure of middle ear and outer hair cell function through the measurement of otoacoustic emissions and tympanometry (using an optional external tympanometry probe). It consists of the handheld unit, external probe(s), printer, single-use eartips and other accessories (Figure 1). 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 the OAE or tympanometry 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 Figure 1 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.

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Operating Instructions EROCSCAN Pro 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 mechanical 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 subsequent printing. The results are displayed via the display 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 optional thermal paper printer or the default PC printer via software interface. Tests can also be exported to a computer database via optional software. Test results are stored in the non-volatile memory so the operator can delay printing until a later time if desired.

1.2 Otoacoustic Emissions What Are DPOAEs? Distortion Product Otoacoustic Emissions (DPOAEs) are acoustic signals that can be detected in the ear canal of a person with normal outer hair cell function, subsequent to stimulation of the auditory system with a pair of pure tones at frequencies f1 and f2. The resulting emission of interest is the distortion product tone at the frequency 2f1-f2. What Are TEOAEs? Transient Evoked Otoacoustic Emissions (TEOAEs) are acoustic signals that can be detected in the ear canal of a person with normal outer hair cell function, subsequent to stimulation of the auditory system with a series of wideband clicks.

Figure 2

What Do Otoacoustic Emissions Results Tell Us? Available evidence suggests that otoacoustic emissions (OAEs) are generated by the cochlea’s outer hair cells, and that the presence of OAEs is an indication that the outer hair cells are normal. Although OAE test data provide no indication of inner hair cell function, or of hearing ability, current research indicates that the majority of hearingimpaired individuals will be identified by a simple OAE test. Patients who fail to generate OAEs should be rescreened and/or referred for additional audiological testing.

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Operating Instructions EROCSCAN Pro 6

How Does the ERO•SCAN Pro Device Measure DPOAEs? The ERO•SCAN Pro instrument generates a series of test tones, directs them into the ear canal, and then measures the level of the DPOAE tone generated by the cochlea. By using different test frequencies, the ERO•SCAN Pro device provides an estimate of outer hair cell function over a wide range of frequencies. How Does the ERO•SCAN Pro Device Measure TEOAEs? The ERO•SCAN Pro instrument generates a series of clicks, directs them into the ear canal, and then analyzes the spectrum of the returning signal, separating the noise and emission. By using bandpass filters, the ERO•SCAN Pro device provides an estimate of outer hair cell function over a wide range of frequencies. 7

How Does the ERO•SCAN Pro Device Work? The digital signal processor in the instrument generates two pure tones (f1 and f2) for DPOAEs or a series of wideband clicks for TEOAEs through a digital-to-analog converter. These tones or clicks are presented to the ear via speaker tubes located in the probe. A microphone in the probe measures the sound in the ear canal and transmits the signal to the analog-to-digital converter. The digital signal processor then uses Fast-Fourier Transforms (FFTs) to filter the signal into narrow frequency bands, and detects any emissions present. The level of these emissions can be compared with the level of the noise.

The SPL and frequencies of the test tones and the averaging time used to process the signals can be determined by the tester through adjustable settings maintained in static memory within the ERO•SCAN Pro instrument. What Frequency Range of Hearing is Estimated? DPOAEs: Approximately 1.5 kHz to 12 kHz (depending on the frequency range selected). Since the health of the hair cells in the region of the f2 test frequency are estimated, and a) the 2f1-f2 emission frequency is at about six-tenths of the f2 frequency, b) emissions tend to be weak below 600 Hz or so, and c) the ambient noise tends to be highest at low frequencies, the lowest f2 test frequency that can be routinely measured is about 1 kHz. TEOAEs: Roughly 500 Hz to 4 kHz. TEOAEs can be reliably recorded at lower frequencies than DPOAEs, but cannot be measured reliably above 4 kHz.

1.3 Tympanometry What is tympanometry? Tympanometry is the objective measurement of middle ear mobility (compliance) and pressure within the middle ear system. During the test, a probe tone (226 or 1,000 Hz) is presented to the ear canal by means of the Tymp OAE Probe. This tone is used to measure the change in compliance in the middle ear system while the air pressure is varied automatically from a positive value (+200 daPa) to a negative value (-400 daPa max.). How is compliance measured? Maximum compliance of the middle ear system occurs when the pressure in the middle ear cavity is equal to the pressure in the external auditory canal. This is the highest peak

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Operating Instructions EROCSCAN Pro of the curve as it is recorded on the chart. The position of the 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 can be found in a later section of this manual. What other measurements are calculated? Gradient calculations are reported as the tympanogram width at half of peak compliance expressed in daPa. A “limits” box is available on both the display and printout to aid in diagnosis. Compliance is measured with respect to an equivalent volume of air, with the scientific quantity milliliter (ml). Air pressure is measured in deca-Pascals (daPa).

What does tympanometry tell us?

Figure 3

The impedance measurement assists in diagnosing of the condition of the middle ear and can therefore not be compared directly with other audiometric tests such as sound or speech audiometry which assists in the measurement of hearing. Furthermore the impedance measurement is an objective Figure 4 measuring method which does not depend on the cooperation of the test person and can therefore not be falsified by the patient. The impedance measurement examines the acoustic resistance of the middle ear. If the eardrum is hit by a sound, part of the sound is absorbed and sent via middle ear to the inner ear while the other part of the sound is reflected. The stiffer the eardrum is the more sound is reflected and the less sound reaches the inner ear. Inside the probe of the impedance measuring instrument a small loudspeaker is installed which emits a low frequency sound through a tube (Figure 3) into the auditory canal before the eardrum. Another tube (Figure 3) is connected to the microphone inside the probe which receives the sound. Together with a third tube (Figure 3), all three are inserted nearly to the eardrum and are made airtight against outside pressure by the ear tip. A manometer and a pump, which can produce both positive and negative pressure, are connected with tube C. Less sound is reflected to the microphone when the eardrum is stiff and the eardrum transmits the majority of the sound via the middle ear to the inner ear. The highest compliance is normally reached with an air pressure corresponding to the outside pressure. When performing tympanometry during a measurement, a continuous change of positive and negative pressure is produced by the pump of the instrument in the outer

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Operating Instructions EROCSCAN Pro auditory canal. The compliance is measured simultaneously and shown in a diagram (the tympanogram) which illustrates the compliance in ml or mmho over the pressure in daPa. In Figure 4, the area for 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 decreases. So you can draw conclusions on the condition of the middle ear from the form and the values of the tympanogram. NOTE: 1.02 mm H2O = 1.0 daPa.

2. Important Safety Precautions The ERO•SCAN Pro Test System should be used only by those individuals trained to perform the testing for which it has been designed. No person should attempt to use this instrument without the necessary knowledge and training to understand how this equipment is to be properly utilized and interpreted. The ERO•SCAN Instrument probe tip must not be inserted into an ear at any time without a disposable eartip properly affixed. IMPORTANT In the event of a critical system failure, the message shown to the left will be displayed. Discontinue use of the instrument and contact your Special Equipment Distributor or contact MAICO Diagnostic by phone at (888) 941-4201 or by fax at (952) 9034100. 2.1 Disclaimer The MAICO ERO•SCAN™ Test Instrument is designed to be a screening device for hearing loss. 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 REFER test result should not be assumed to be an indicator of a lack of auditory function; however, it should be followed with full audiologic diagnostic testing. NOTICE: Under certain circumstances, especially in low-humidity environments, common electrostatic discharge may cause this instrument to turn itself off. This effect causes no permanent damage, and the instrument may be turned on again by the normal procedure of holding the DOWN button.

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Operating Instructions EROCSCAN Pro 2.2 • • • • • • • • • • • • • •

Precautions READ THIS ENTIRE MANUAL BEFORE ATTEMPTING TO USE THIS SYSTEM. Use this device only as described in this manual. Use only the disposable eartips designed for use with this instrument. Never insert the probe tip into the ear canal without affixing an eartip. The eartips are disposable and for single patient use only. Do not clean or reuse eartips. Use only disposable 1.5v AA/UM-3/R6 Alkaline batteries for the test instrument. Do not use rechargeable cells 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. See the Care and Maintenance section of this manual for proper cleaning procedures. 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. Use and store the instrument indoors only. Do not use this instrument or its accessories in temperatures below 40°F (4°C) or above 100°F (38°C), or in relative humidity of more than 90%. Do not attempt to open or service the instrument. Return the instrument to the manufacturer for all service. Opening the instrument case will void the warranty. Do not operate the printer if the power supply has a damaged cord or plug. See the instructions on the following page. Do not expose the printed results to sunlight or heat. Printing on thermal paper fades with exposure to light or heat. Photocopies of test results should be made if the records are to be kept indefinitely.

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Operating Instructions EROCSCAN Pro Printer AC Power Source Precautions • The printer AC power source converts main voltage (120V AC or 230V AC) to a low voltage (12V DC) for powering the printer. Use only the power source supplied for this purpose. • This product is for indoor use only. Do not expose to water or excessive dust. • This product is not suitable for operation in the presence of flammable anesthetic mixture with air or with nitrous oxide. • Do not cover the power source body as it may result in excessive heating. The power source operates when the plug is inserted into an outlet. To turn it off, remove the plug from the outlet. The outlet must be easily accessible and located near the printer. Should a faulty condition occur, remove the plug from the outlet immediately. • High Voltage Inside! Do not remove the power supply cover! All service or maintenance must be done by trained personnel. Return the power supply to the manufacturer for service. Cleaning and Disinfecting the Unit Wipe the surface with a cloth slightly dampened with mild detergent or normal hospital bactericides. Do not immerse the unit. Do not clean the unit with isopropyl alcohol or other solvents. Optional Printer Rechargeable Battery Precautions • Do not attempt to open the battery pack. The printer battery pack contains NiMh cells. Cadmium is a potentially toxic heavy metal, and exposing the cells increases the risk of leakage or short-circuiting. • Do not short circuit the battery contacts. This could cause burns or a fire. • Disconnect the printer power supply before removing or replacing the battery pack. • Observe local regulations for handling, transport, and disposal of Ni-Mh cells. Regulations in many areas prohibit the disposal of Nickel-Cadmium cells. Complete battery packs may be returned to the manufacturer for recycling. • The battery pack must be charged for a minimum of five hours before using the printer for the first time. Failure to fully charge the battery pack before use may reduce the life of the battery pack. 5

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Operating Instructions EROCSCAN Pro 3. Getting Started 3.1 Unpacking the system Standard System Parts (OAE): (1) ERO•SCAN™ Pro Handheld unit w/ internal probe (1) Cradle (1) USB cable (4) AA/UM-3/R6 Alkaline batteries (4) Internal probe tips (4/pkg) (1) Box of disposable eartips in assorted sizes (1) Thermal Paper Printer with Lithium Ion battery installed with: (1) Thermal printer paper roll (1) Printer charger (1) Power supply cord (1) Printer cable (1) ERO•SCAN Pro PC software CD (1) Operating Manual Additional Standard Parts for ERO SCAN Pro with Tymp: (1) External TympyOAE Probe™ with: (1) Calibration cavity (4) External probe tips (4/pkg) Optional System Parts: (1) External OAE•Probe™ (4) External probe tips (4/pkg)

Standard System Parts

Handheld

Cradle

AA Batteries

Eartip Kit Internal Probe Tips

Printer

Thermal Paper Roll

Power supply cord

Operating Manual & PC Software CD

Printer Cable

Standard Parts for OAE and Tymp

Note: It is recommend that you save the box and packing materials in case you need to store or ship the system.

TympyOAE Probe

Figure 5

Ext. OAE Probe

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USB Cable

Calibration Cavity

External Probe Tips

Optional Parts

8

External Probe Tips

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Operating Instructions EROCSCAN Pro 2.2

Battery Installation

The ERO•SCAN Pro instrument uses 4 AA/UM-3/R6 Alkaline batteries. Open the battery compartment by sliding the battery panel down and install the batteries as indicated on label inside the compartment. Once the batteries are correctly in place, slide the panel back onto its tracks to close the battery compartment. (Figure 6)

Figure 6

2.3 Environmental conditions The MAICO ERO•SCAN™ Pro should be operated in a quiet room, so that the examinations are not influenced by outside noises. Electro-medical instruments, which emit strong electromagnetic fields (e.g. microwaves radiotherapy devices), can influence the function of the MAICO ERO•SCAN™ Pro. Therefore the use of these instruments is not allowed in close proximity to the MAICO ERO•SCAN™ Pro. The test room must be at normal temperature, usually 15°C / 59°F to 35°C / 95°F, to guarantee precise measuring results. If the device has been cooled down (e.g. during transport), please wait until it has warmed up.

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Operating Instructions EROCSCAN Pro 4. Getting familiar with the ERO•SCAN Pro 4.1 Controls and display (Figure 7) Power Button: Press to power on Press and hold to power off Info Button: View detailed information about the selection Navigator: Up/down arrows change the selection shown on the middle line Left/right arrows initiate the action shown in the bottom line of the display. Test Status Indicators: Green – indicates the instrument is ready to test Yellow – indicates test is in progress Amber – indicates an error condition

Figure 7

4.2 Internal Probe The internal probe is located on the underside of the ERO•SCAN Pro instrument (Figure 8). It allows for the measurement of DPOAEs in the range of 1.5 kHz to 6 kHz and TEOAEs in the range of 0.7 kHz to 4 kHz. Note: Tympanometry and high frequency DPOAE measurements are not supported by the internal probe of the ERO•SCAN Pro. The internal probe consists of a patented dual isolated spring design which prevents hand movement from being transferred to the ear canal where it would be measured as noise (a common problem with any truly handheld OAE probes). Figure 8

The internal probe assembly houses the microphone which measures the acoustic information present in the ear canal and the tubing which carries the stimulus from the receiver(s) 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 snaps to the shaft of the spring assembly and serves as an attachment point for the disposable eartips.

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Operating Instructions EROCSCAN Pro 4.3 External Probes (optional) There are two types of external probe available for use with the ERO•SCAN Pro instrument (Figure 9). Each consists of the following basic parts (Figure 10): 1. Connection cable – connects probe to ERO•SCAN Pro instrument by way of the connector 2. Probe enclosure – contains the circuitry, one receiver, and, in the case of the Tymp•OAE Probe, the pump and pressure sensor 3. Keypad – consists of LED status indicators and Right/Left test start buttons 4. Probe cable – connects the probe enclosure to the probe head 5. Probe head – contains the microphone and one receiver 6. Probe tip – disposable tip onto which the eartip is affixed for sealing to the ear

Figure 9

Figure 10

OAE•Probe™ The OAE•Probe allows for the measurement of DPOAEs in the range of 1.5 kHz to 12 kHz and TEOAEs in the range of 0.7 kHz to 4 kHz. Tymp•OAE Probe™ The Tymp•OAE Probe allows for measurements of tympanometry with a 226 Hz or 1000 Hz probe tone, DPOAEs in the range of 1.5 kHz to 12 kHz, and TEOAEs in the range of 0.7 kHz to 4 kHz.

The external probe keypads consist of a left (indicated by L) and right (indicated by R) button to initiate the selected test protocol or series. Below the left and right buttons are blue (for left) and amber (for right) LEDs which illuminate during testing to indicate the ear under test (Figure 11)

Figure 11

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Each probe provides a status indictor in the form of LED(s) located on the keypad (Figure 11). In the case of the OAE•Probe the indicator is between the left and right buttons. On the Tymp•OAE Probe the indicator is a row of LED’s above the left and right buttons.

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Operating Instructions EROCSCAN Pro 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 Yellow: AutoStart in process Solid Yellow: Testing in progress The status indicator bar on the Tymp•OAE Probe will indicate the pressure sweep of the pump by showing a sweeping sequence of lights. Note: When idle (not testing) the probe status LED should be solid green. If the LED is yellow when idle then the probe has not been detected by the instrument. Power off the instrument, check the probe connection, and turn the instrument on again to detect the probe. The status LED should now be solid green.

The external probes are preferred by most users when conducting OAE measurements for infants, young children, and other difficult to test populations such as individuals with multiple handicaps. The external probe allows the user to insert the probe tip into the ear and then wait until the patient is quiet before starting the test. The internal probe may be preferred by some users for fast OAE testing of cooperative parents. Installing the External Probe 1. Turn off the ERO•SCAN Pro and insert the external probe plug into the socket on the top of the ERO•SCAN Pro (Figure 12). The plug will fit only in one direction. The arrows on the plug should face the display on the ERO•SCAN Pro. 2. Turn on the ERO•SCAN Pro. The status indicator on the external probe keypad will be solid greed indicating the ERO•SCAN Pro has detected the presence of the remote probe. 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 instrument off, disconnect the external probe and power up the instrument again. Figure 12

Note: Misalignment of the plug and socket when installing the remote probe can cause damage to the pins in the plug and the pin receptacles in the socket. The plug and socket should be visually inspected prior to each installation of the remote probe. If damage is observed, contact your Special Equipment Distributor or MAICO Diagnostic.

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Operating Instructions EROCSCAN Pro 5. Conducting a Measurement 5.1

Quick Start

Figure 13

The ERO•SCAN Pro instrument arrives preloaded with default protocols and ready to test. Testing with the external probe can be started with just five easy steps. 1. Turn on the instrument. 2. From the main menu (Figure 13), select the desired protocol or series using the up or down arrows on the navigator. 3. Select an eartip and place if fully on the probe tip. 4. Secure the probe to the patient and insert the eartip deeply into the patient’s ear. 5. To begin a test Press the right or left arrow button on the control panel (Figure 7) or press the L or R button on the external probe (Figure 11). Note: The exact sequence for these steps can be adjusted based on user preferences, the probe being used (internal or external), and the patient being tested (adult or pediatric). Additional information on each step is provided below.

Important: When Tymp•OAE Probe 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 canal either BEFORE or AFTER the pump initialization.

5.2

Powering on the Instrument To turn on the ERO•SCAN Pro instrument, press the power button located on the handheld control panel just below the left corner of the display window.

Figure 14

A flash screen (Figure 14) showing the firmware version (first line), serial number (second line), and date set in the instrument (third line) will illuminate briefly before showing the main display (Figure 13).

Important If testing with the external probe, be sure to connect the external probe prior to powering on the instrument. When the probe is detected the status indicator on the external probe keypad will be green. If testing with the internal probe, be sure the external probe is disconnected prior to powering on the instrument.

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Operating Instructions EROCSCAN Pro 5.3

Selecting a Protocol or Protocol Series Protocols are individual DPOAE, TEOAE, or Tympanometry measurements. Protocol Series are a sequence of individual protocols linked together. A series can be composed of any combination of DPOAE, TEOAE, or Tympanometry protocols that are loaded into the instrument. The series will run with just one button press (left/right arrow on control panel or R/L Figure 15 button on probe) to begin testing. Series are indicated by multiplicity symbol to the left of the Series name (Figure 15). Each instrument comes preloaded with protocols and protocol series. For a description of the protocols and series included see Appendix B. For information on creating and customizing protocol series see section 9. The protocol selected will default to the last protocol or series used to conduct a measurement. This makes it easy to switch to the other for testing. To select a different protocol or series use the up and down arrows on the navigator located on the instrument control panel. 5.4 Selecting an Eartip The ERO•SCAN Pro instrument comes with a box of disposable eartips that fit a variety of ear canal sizes. The probe tip must have an eartip attached before inserting it into an ear canal. The eartip kit has 12 different size eartips that are color-coded for easy selection. 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. 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 extend too deeply into the ear canal. Use only the eartips approved for use with the instrument. Contact your local special equipment distributor or MAICO Diagnostic for ordering information. The eartips are disposable and should be replaced after each patient. Do not attempt to clean or reuse these eartips. After selecting an eartip, push it onto the probe tip until it is flush against the base of the probe tip. The sound outlet tubes on the probe tip are recessed to minimize the likelihood of clogging. If the probe tip does become plugged or clogged, it must be replaced. See section 11 on care and maintenance for further information. To remove the eartip, grasp the eartip at the base and twist it while pulling it straight off the end of the probe tip. 5.5 Preparing the Patient If possible, otoscopic or visual 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 an audiologist or physician for removal of the blockage prior to testing. Place the patient in a position that will allow easy access to the patient’s ears. The patient should remain still and quiet while the test is being performed.

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Operating Instructions EROCSCAN Pro Explain to the patient that the measurement is painless. The patient does not have to respond when there are loud test sounds or when the pressure in the auditory canal changes. The patient should be instructed not to swallow, chew or move during the measurement. Securing the External Probe to the Patient The external probe 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 (Figure 16). Selecting the style for use will depend on patient factors and the preferences of the user. Adjusting Lanyard The lanyard is affixed to the probe enclosure with an auto-locking mechanism. To adjust the lanyard position, slide the locking mechanism down (toward to the connection cable) and hold the mechanism in the downward position while pulling the lanyard in the desired direction. Pull the lanyard down (toward the connection cable) to use the shirt clip or up (toward the probe cable) to use it as a neck loop. Once in position, release the locking mechanism and pull up gently on the lanyard.

Lanyard Use

Neck Loop

Shirt Clip Figure 16

Important: Secure the probe enclosure using the neck loop or shirt clip such that there is no weight on the probe cable and eartip. The probe enclosure should be positioned as close to the ear as possible 5.6 Conducting a measurement After selecting the desired protocol or series, press the right or left arrow button on the navigator or L or R button on the external probe keypad to begin a measurement. Select the left arrow or L button to start a left ear test. Press the right arrow or R button to start a right ear test.

AutoStart The first phase in the test sequence is AutoStart which checks the fit of the probe in the ear canal. The actual calibration and measurement will commence once an adequate probe fit has been achieved. The sequence can be started with the probe placed in the ear or prior to positioning the probe in the ear. This is a matter of user preference.

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Operating Instructions EROCSCAN Pro Users of the internal probe tend to prefer to start the test before positioning the probe in the ear. AutoStart consists of low-frequency, alternating tones which are used to check for the following conditions: Seal of the eartip to the ear canal, leak, blocked probe, clogged probe tip, stability of the probe, and noise. During AutoStart the condition of the probe in the ear is represented by the following images: Probe not in ear or leak (Figure 17):

Figure 17

This image indicates the probe is outside the ear canal or there is no seal. Continue to insert the probe into the ear canal. If this condition persists, a different eartip may be required. Be sure the eartip is securely seated deep in the ear canal. Probe in ear and seal detected (Figure 18):

Figure 18

This image indicates the probe is in the ear canal. The test will start soon as long as all conditions of AutoStart are met. If the test does not begin, that may be the result of instability (probe is moving because fit is not secure or the patient is too active) or there is excessive noise present. If this image persists and testing does not begin, refit the probe and try again. A different eartip may be required. Probe blocked (Figure 19):

This image indicates the probe is blocked. The eartip or probe tip might be blocked by ear wax (cerumen) or vernix (birth fluid) or the probe has been pushed against the wall of the ear canal. Figure 19

Remove the probe from the ear and check for wax/debris then reinsert changing angle or position of the probe until AutoStart image 2 appears. If the blocked probe condition persists, see section10 on Troubleshooting.

Note: Do not hold the probe in the ear during OAE testing. This will introduce noise into the measurement. Common sources of noise are environmental (room noise), biological (patient breathing, moving, talking, chewing, etc.), or physical (probe movement).

Testing ears with PE tubes. To test OAE’s of individuals with PE tubes or middle ear perforations, the autostart may need to be disabled. This is accomplished by first inserting the probe with eartip attached into the ear canal. Be sure the fit is deep and secure to obtain a proper seal, To disable autostart at the main menu select the ear to be tested by holding down the right or left arrow key for 3 seconds until the green light turns off. Once the key is released, the EROySCAN Pro will calibrate and test as usual. Calibration

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Operating Instructions EROCSCAN Pro The ERO•SCAN Pro will automatically perform a calibration prior to each frequency tested (DPOAE) or at the start of each test (TEOAE).

Test Phase During the test phase an hourglass symbol will appear to the right of the display (Figure 20). Test results are shown as they are collected. For more information 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 turns on. The display on the ERO•SCAN Pro test instrument will indicate the results of the test with a graphic display. The display will be generated and shown during the test and can be reviewed after the test is complete. The display you see might differ depending on the settings used for the test. Figure 20

Figure 21

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The results of the test are automatically displayed on screen (Figure 21) and saved in memory as soon as the test is complete. The results will be saved even if the unit turns off or the batteries are temporarily removed. This screen indicates the test ear and further gives the results of the test. “PASS” on the screen indicates the patient passed the screening, “REFER” indicates that the patient did not pass the screening. For additional information on test results, please see section 5 of this manual.

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