Page 1 Otoport User Manual for Otoport Advance model Otoport OAE+ABR Otoport Advance model Issue 8.1...
Page 2 No part of this publication may be copied by any means, translated or distributed to third parties without the express written permission of Otodynamics Ltd. Copyright © 2016 Otodynamics Ltd. All Rights Reserved. Otodynamics Ltd 30-38 Beaconsfield Rd Hatfield Herts AL10 8BB UK...
Page 3 Contents Introduction Intended Use General Guidance General use precautions Types of otoacoustic emissions Advanced DPOAE test measurements Auditory Brainstem Response Training Equipment identification Supplied only in Otoport OAE+ABR kit Supplied only in Otoport OAE kit Supplied in OAE and OAE+ABR kits Optional accessories Controls, indicators and connections Scanner...
Page 4 Switching on Switch on screen Logo screen Login Scrolling modules Test preparation General checks before testing Environment checks for ABR Tip selection and probe fitting Helpful hints Electrode fitting Test troubleshooting OAE test problems ABR test problems OAEs and screening Testing options Patient details Entering patient data...
Page 5 Otoport OAE+ABR User Manual for Advance and Screener DPOAE test Test choice 10.1 DPOAE Checkfit 10.2 Calibration 10.3 DPOAE recording 10.4 DPOAE test results 10.5 DP Growth 10.6 ABR test Test choice 11.1 Impedance check 11.2 ABR Checkfit 11.3 ABR test 11.4 Bilateral ABR testing 11.5...
Page 6 Management Management menu 16.1 Users menu 16.2 Facility and risk 16.3 Date and time 16.4 Other options 16.5 Test set-up Test setup menu 17.1 Edit mode menu 17.2 Test config 17.3 TEOAE test config 17.4 DPOAE test config 17.5 ABR test config 17.6 Stop criteria 17.7...
Page 7 Otoport OAE+ABR User Manual for Advance and Screener QA area QA area menu 20.1 Probe test 20.2 ABR cable test 20.3 Probe, tips and accessories Probe and service accessories 21.1 Probe cable clip 21.2 Probe tips 21.3 Probe care Cleaning 22.1 Changing probe coupler tubes 22.2...
Page 8 Training Obtaining service Calibration Mode of operation TE Test 29.1 DP Test 29.2 ABR test 29.3 Response detection Confidence levels in DPOAE tests 30.1 Confidence levels in TEOAE tests 30.2 Conclusions 30.3 Technical specifications General 31.1 Electromagnetic Compatibility: Otoport 31.2 Electromagnetic Compatibility: Otoport OAE+ABR 31.3 EN60645-3 conformance notes...
Page 9: Intended Use
Otoport OAE+ABR User Manual for Advance and Screener Introduction This manual provides instructions for the use of the Otoport OAE+ABR (Otoport Advance and Screener models). Instructions that apply only to the Otoport Advance are indicated with the following symbol: OTOPORT ADVANCE...
Page 10: General Guidance
Setup, section , ABR stop criteria). OAE screening functions include 17.7.3 Otodynamics classic Quickscreen TEOAE technology and Rapid DPOAE technology (depending on the model). The device can be used in a wide range of different environments for example in the well-baby nursery, the NICU, a doctor’s office, an audiology clinic, the outpatient clinic or in the home.
Page 11: General Use Precautions
Otoport OAE+ABR User Manual for Advance and Screener General use precautions TRAINING REQUIRED The Otoport pass criteria are set in the Test set-up area (see section 17.7 It is the responsibility of the user to ensure that the pass criteria set meet their requirements.
Page 12: Types Of Otoacoustic Emissions
If additional hygienic protection is required, clear plastic infection control sleeves designed to contain the Otoport during use are available from Otodynamics. Otodynamics does not guarantee the accuracy of the test results or the tests themselves, if accessories other than those supplied by Otodynamics are used.
Page 13 With a click or other brief stimulus it is possible to record Transient Evoked Otoacoustic Emissions (TEOAE) The Otoport Advance currently records DPOAEs and TEOAEs, the Otoport Screener records TEOAEs only. The difference between TEOAE and DPOAE measurements is largely in the means used to generate and measure the emission, rather than in the interpretation of emission.
Page 14 Recording otoacoustic emissions below 2kHz can be more difficult with DPOAEs in noisy situations than with TEOAEs. Otodynamics recommends a combination of both tests and a range of stimulus levels for clinical investigations.
Page 15: Advanced Dpoae Test Measurements
Otoport OAE+ABR User Manual for Advance and Screener Advanced DPOAE test measurements OTOPORT ADVANCE ONLY Setting stimulus parameters 1.5.1 DPOAE tests are defined by the frequencies presented (referred to as F1 and F2) and the amplitude level at which they are presented (L1, the level of F1 and L2 the level of F2).
Page 16 CHAPTER ONE Introduction Stim F2 (Hz) Stim F1 (F2/1.22) (Hz) DPOAE (2F1-F2) (Hz) 1000 1189 1414 1159 1682 1379 1076 2000 1640 1280 The pts/oct setting chosen depends on the requirements of the test. The higher the resolution the more accurately the cochlea is assessed but the test duration is longer.
Page 17 Otoport OAE+ABR User Manual for Advance and Screener Setting stimulus intensity levels 1.5.2 The levels of stimuli F1 and F2 (L1 and L2 respectively) are important test parameters. In general, higher L1 and L2 levels lead to higher DPOAE responses but result in tests which are less sensitive to hearing loss.
Page 18 CHAPTER ONE Introduction DPgrams made with lower levels of stimulation are more sensitive to early pathology than those with high stimulus levels. When DPOAEs are found at higher stimulus levels but not lower stimulus levels, the suspicion of significant damage and hearing loss is increased but the suspicion of a severe loss is reduced.
Page 19 Otoport OAE+ABR User Manual for Advance and Screener Uses of DP Growth 1.5.5 Healthy ears tend to show a shallow slope (linear growth of DP decibel level with stimulus level) and low DP threshold values. Ears with hearing loss tend to show a steeper slope and higher DP thresholds.
Page 20: Auditory Brainstem Response
CHAPTER ONE Introduction Auditory Brainstem Response Auditory Brainstem Response (ABR) is an electrophysiologic response that measures the auditory system’s response to sound. Three sensors are placed on the patient and a probe is placed in the test ear. The equipment sends a soft clicking sound to the ears and the sensors pick up the nerve’s response to that sound.
Page 21: Training
The manual should be read before use and note taken of the sections marked with the training required symbol. Training in the UK is provided by Otodynamics Ltd. Training elsewhere is via an approved dealer who has been trained by Otodyanmics. Training on OAEs, ABRs and use of the equipment may also be provided by previously trained staff and qualified audiologists.
Page 22: Equipment Identification
CHAPTER TWO Equipment identification Equipment identification Supplied only in Otoport OAE+ABR kit REF ADV-ABR Otoport Advance OAE+ABR SCR-ABR Otoport Screener OAE+ABR REF ABR-EC1 Electrode cables - 1m ABR-EC2 Electrode cables - 2m REF ABR-SK Starter kit of electrodes pack, skin preparation gel and pack of...
Page 23: Supplied Only In Otoport Oae Kit
Probe cavity and ABR cable tester REF ABR-INF Infection control sleeve for Otoport OAE+ABR unit only REF ABR-CAS Equipment case for Otoport OAE+ABR kit Supplied only in Otoport OAE kit REF OAC-S Otoport Advance OSC-S Otoport Screener REF OAE-CAV Probe test cavity...
Page 24: Supplied In Oae And Oae+Abr Kits
REF OP-CAS Equipment case for Otoport OAE kit Supplied in OAE and OAE+ABR kits REF PR-UGD UGD DPOAE probe Supplied with Otoport Advance REF PR-UGS UGS TEOAE probe Supplied with Otoport Screener REF PR-POUCH Drawstring probe pouch Re-order quantity: 10...
Page 25 Re-order codes: REF TPC-10 (quantity: 10) REF TPC-100 (quantity: 100) REF BGD BGD probe body and lid x 1 Supplied with Otoport Advance Re-order quantity: 10 REF BGS BGS probe body and lid x 1 Supplied with Otoport Screener Re-order quantity: 10...
Page 26 Charger and mains lead REF OP-CAB PC downoad cable REF OTOLINK Otolink software CD REF OP-INF Infection control sleeve for Otoport only Shown fitted REF ODS Docking station Supplied with Otoport Advance. Provides connections for printing, charging and downloading to PC...
Page 27: Optional Accessories
Includes instrument and software manuals, quickstart and probe use guides Optional accessories REF OPP-CAS Large equipment case For use with Otoport Advance and Otoport Screener OAE devices, with additional compartment for printer REF ODS Docking station Optional accessory for Otoport Screener.
Page 28 CHAPTER TWO Equipment identification Printer accessories and consumables 2.4.1 REF OMP-CAB-R Otoport printer cable For use with Otoport Advance and Otoport Screener OAE devices (not for use with ABR) REF OMP-CHG-R Otoport printer charger REF OMP-PAP-R Otoport printer paper rolls...
Page 29: Controls, Indicators And Connections
Otoport OAE+ABR User Manual for Advance and Screener Controls, indicators and connections Probe socket Stimulus OK (S) and Noise OK (N) indicators Display screen Menu selection keys Arrow (up/down/ left/right navigation) keys Data entry keypad On/Off power key Charging status indicators Speaker Charger and PC...
Page 30: Scanner
CHAPTER TWO Equipment identification Scanner Barcode/RFID scanner (not included as standard) Grip strip...
Page 31: Oae Labelling
Otoport OAE+ABR User Manual for Advance and Screener OAE labelling Symbols 2.7.1 The label uses one or more of the following symbols: Caution Refer to user manual Class II electrical protection (double insulated) Type BF applied part Bluetooth ® enabled RFID enabled...
Page 32 CHAPTER TWO Equipment identification Manufacturer Serial Number The Otoport serial number comprises model code (OAC or OSC), year and month of manufacture (yymm) and unique manufacture ID (xxxx). The complete serial number is therefore OXX/yymmxxxx. Certification or regulatory marks 2.7.2 The label features one or more of the following certification/regulatory marks: CE Mark (with Notified Body number) (EEA)
Page 33 Otoport OAE+ABR User Manual for Advance and Screener Otoport OAE+ABR controls, indicators and connections Probe sockets and electrode sockets Impedance check indicator LEDs Quick-release clips Otoport unit Otoport controls and keypad ‘USB/PSU’ connected’ and ‘battery charging’ indicator LEDs Charger / PC cable socket...
Page 34: Abr Labelling
CHAPTER TWO Equipment identification ABR labelling Symbols 2.9.1 The label uses the following symbols: Bluetooth enabled Caution Refer to user manual Class II electrical protection (double insulated) Type BF applied part Manufacturer Serial Number...
Page 35: Serial Number
User Manual for Advance and Screener Serial number 2.9.2 The Otoport Advance OAE+ ABR system complies with the unique device identifier system to aid the identification of medical devices within the healthcare supply chain. The fields in the serial number are made up of the following parts:...
Page 36: Getting Started
CHAPTER THREE Getting started Getting started If you have purchased the ABR Module as an upgrade to your Otoport, you will first need to assemble the equipment, as follows. Assembling the ABR Module with an Otoport The ABR Module is designed to be fitted as a ‘sleeve’ to an Otoport unit, as described in the following instructions: Do NOT force the Otoport into the ABR sleeve.
Page 37 Otoport OAE+ABR User Manual for Advance and Screener Slightly tilt the upper section back (see diagram on label inside Module). 3.1.3 Do NOT tilt it forwards and do NOT force it back. Carefully insert the Otoport into the sleeve and slide it down until the 3.1.4 connector at the bottom of the sleeve is inserted into the port at the bottom of the Otoport...
Page 38 CHAPTER THREE Getting started Do NOT insert the Otoport into the top of the module first, or insert into the bottom of the sleeve at an angle, as this may cause damage. Lower the sleeve until the connector at the top of the ABR Module is 3.1.6 inserted into the Otoport. Close the clips. 3.1.7...
Page 39 Otoport OAE+ABR User Manual for Advance and Screener Removing the Otoport from the ABR Module If you need to remove the Otoport from the ABR Module at a later time, carefully follow these steps: Open the clips on each side. 3.2.1 Slide the top half of the ABR sleeve up and and tilt it back.
Page 40: Connecting Probes And Electrodes
CHAPTER THREE Getting started Connecting probes and electrodes The connections panel for probes and electrodes is found at the top end of the module. Connecting the probe 3.4.1 Follow instructions for connecting the probe to the Otoport in section If you are using two probes, ensure that the probe head colour matches the probe socket;...
Page 41: Connecting The Electrodes
Otoport OAE+ABR User Manual for Advance and Screener Some Otoport models only allow a single probe connection to probe socket one. In this case, one probe socket will be blocked. Connecting the electrodes 3.4.2 The Otoport OAE+ABR is supplied with an electrode cable loom featuring snap stud connectors for electrode attachment.
Page 42: Initial Charge
CHAPTER THREE Getting started Initial charge Before using your Otoport for the first time, fully charge the unit. See chapter Otoport Power for details. Quickstart Quickstart guides for OAE and ABR tests, included as separate items in your document pack, are shown on the following pages.
Page 43 OAE QUICKSTART Otoport Advance Step 1. Setting up your Otoport knurled sleeve With the arrow at the front, Press the button to turn Date, time and battery connect the DP (grey) probe on the Otoport. Confirm status are displayed while and screw the knurled sleeve within 2 seconds by system checks are per-...
Page 44 Select Right or Left ear using details for a new patient. and keypad to enter patient buttons. details. Press to SAVE. SAVE and CONFIRM your choice. Otodynamics Ltd www.otodynamics.com US Toll free: 1 800 659 7776 International: +44 (0)1707 267667 Email: support@otodynamics.com...
Page 45 OAE QUICKSTART Otoport Screener Step 1. Setting up your Otoport knurled sleeve With the arrow at the front, Press the button to turn Date, time and battery connect the probe and screw on the Otoport. Confirm status are displayed while the knurled sleeve until finger within 2 seconds by system checks are...
Page 46 Do NOT turn the main probe Gently pull out the probe. body. Otodynamics Ltd 30-38 Beaconsfield Rd Hatfield Herts AL10 8BB UK 0120 www.otodynamics.com Email: support@otodynamics.com US Toll free: 1 800 659 7776 © Otodynamics International: +44 (0)1707 267667 Ref: MOSCQ.2 October 2015...
Page 47 Otodynamics Ltd. 30-38 Beaconsfield Rd Hatfield Herts AL10 8BB UK www.otodynamics.com, International: +44 (0)1707 267667, Email: support@otodynamics.com © Otodynamics Ref: MOABRQ.6 Oct 2015 0120...
Page 48: Using The Keys And Keypad
CHAPTER THREE Getting started Using the keys and keypad Control keys 3.7.1 The keys directly below the screen marked with a square, a diamond or a circle enable you to execute the functions offered on the screens. Their functions vary from screen to screen, but generally the right (circle) key provides affirmative options and the left (square) key provides negative options.
Page 49 Otoport OAE+ABR User Manual for Advance and Screener Entering characters 3.7.3 Character entry is similar to a mobile phone where numbered keys can be pressed sequentially to select the required character. The order of the characters is dependent on context. For example when used to enter: Patient ID Numbers are presented first then capitals, e.g.
Page 50 CHAPTER THREE Getting started Entering dates 3.7.5 A right arrow symbol is shown at the end of a date field. When the field is highlighted, press the right arrow key to access the calendar pop-up table. The day will be highlighted first and can be altered using the up/down arrow keys.
Page 51 Otoport OAE+ABR User Manual for Advance and Screener Deleting characters 3.7.7 The bottom right hand key is the Delete key. If the cursor is at the end of a row of characters, press this key to delete the last character. The Contrast function indicated on this key is no longer available.
Page 52 CHAPTER THREE Getting started Stimulus and Noise OK indicators (blue LEDs) 3.7.10 The two blue LEDs above the screen on the Otoport give an indication of whether stimulus and noise levels are acceptable for data collection. The Stimulus LED is highlighted with an S. It is lit when the stimulus level recorded by the probe microphone is within the expected range.
Page 53: Connecting The Probe
Otoport OAE+ABR User Manual for Advance and Screener Connecting the probe TRAINING REQUIRED Prior to the testing session, connect the probe to the Otoport. The probe plug contains a ‘key’ that must be aligned with the ‘keyway’ in the probe socket on the Otoport. Probe key Socket keyway The arrow at the front of the probe plug indicates the position of the ‘key’...
Page 54: Disconnecting The Probe
CHAPTER THREE Getting started Push the probe into the socket until it hits the end stop. DO NOT force in the probe. Probe in socket Screw up the knurled sleeve in a clockwise direction until finger tight. Turn knurled sleeve clockwise Disconnecting the probe To disconnect the probe, unscrew the knurled sleeve in an anticlockwise direction until the thread is disengaged.
Page 55 Otoport OAE+ABR User Manual for Advance and Screener Then gently pull the probe out from the probe socket. Remove probe Important Note: Do NOT attempt to screw or unscrew the probe by holding the main probe body (smooth chrome section). Main probe body This will result in damage to the probe and will invalidate the...
Page 56: Switching On
CHAPTER FOUR Switching on Switching on Switch on screen To switch on the Otoport press the green On/Off power key found at the bottom left of the keypad. The display screen will show Switch Unit On?. Select Yes to confirm Otoport switch on, or No to turn the unit off again. If Yes or No are not selected within two seconds of pressing the on/off power key, the device will automatically turn off.
Page 57: Logo Screen
User Manual for Advance and Screener Logo screen Following switch on, an Otodynamics logo animation is displayed whilst the device performs a series of hardware system checks. In the unlikely event of any of the systems checks failing, an error message will be displayed Hardware fault messages for details).
Page 58: Login
CHAPTER FOUR Switching on Login If Login is On the login screen will be displayed and the user will be required to enter a name and password. Use the left/right arrow keys to choose the correct user name from the choice bar.
Page 59: Scrolling Modules
User Manual for Advance and Screener Scrolling modules The TEOAE Test module screen is displayed following switch-on. The DPOAE Test screen (Otoport Advance only), ABR Test screen and other module screens can be accessed using the left/right arrow keys. Choose Select to enter each menu.
Page 60: Test Preparation
CHAPTER FIVE Test preparation Test preparation TRAINING REQUIRED Good preparation for testing will improve test results and make testing more efficient and less stressful for the baby, parents and tester. General checks before testing Ensure the Otoport is charged (see chapter Otoport power for information).
Page 61: Tip Selection And Probe Fitting
Otoport OAE+ABR User Manual for Advance and Screener Tip selection and probe fitting Tip selection and probe fit are essential to ensure successful OAE recordings. A good probe fit will help to block out external noise and enhance the OAE signal. The Otoport is supplied with a full range of tips to fit all ear canal sizes (see section Probe tips).
Page 62 CHAPTER FIVE Test preparation Fitting for infants using ear cups 5.3.2 Only the Sanibel Infant Earcup (www.sanibelsupply.com) is approved for use with the Otoport ABR. Fit a tip to the probe before fitting the probe to the ear cup. The T7M tip for TE probes and the R7M tip for DP probes should be used;...
Page 63: Helpful Hints
Otoport OAE+ABR User Manual for Advance and Screener The weight of the probe cable should be supported to minimise the risk of the probe being pulled out during testing. Use the probe cable clip supplied, ensuring there is sufficient slack in the cable to allow for movement of the patient’s head.
Page 64: Electrode Fitting
CHAPTER FIVE Test preparation Electrode fitting Skin preparation 5.5.1 The skin at the electrode sites must be prepared to ensure that the impedance is low enough for a good recording. Use electrode skin preparation pads/tape, exfoliating pads (e.g. Dry Prep), or a swab coated with Nuprep™...
Page 65 Otoport OAE+ABR User Manual for Advance and Screener Placement (montage) 5.5.2 Electrodes are placed at three sites: the high forehead, the nape of the neck, and a reference (common) electrode on either the shoulder or cheek. In all locations avoid hair when possible. When using wet gel electrodes the sticky area around the central gel should be pressed to the skin –...
Page 66 CHAPTER FIVE Test preparation If using snap stud electrodes, now connect the electrode cables to the sensors. Connect the red cable to the high forehead, the white cable to the nape of the neck and the black cable to the back of the shoulder. Alternative electrode placements The Otoport is optimised for the electrode placements described above.
Page 67: Test Troubleshooting
Otoport OAE+ABR User Manual for Advance and Screener Test troubleshooting OAE test problems The most frequent cause of unsuccessful OAE recordings is failure to fit the probe correctly, so that it is deep enough in the ear canal. The presence of fluid and debris in the ear canal or middle ear will also inhibit recordings.
Page 68: Abr Test Problems
CHAPTER SIX Test troubleshooting ABR test problems Impedance values are too high and the test will not run 6.2.1 Solutions: Wait for about two minutes. During this time the electrodes may connect better to the skin and, therefore, reduce the impedance values. 1.
Page 69 Otoport OAE+ABR User Manual for Advance and Screener 5. Touch each electrode to identify which is causing the problem, try: • holding the skin around the electrode taut • maintaining light pressure on the electrode • gently stroking the baby’s head •...
Page 70: Oaes And Screening
CHAPTER SIX Test troubleshooting OAEs and screening OAE testing is commonly used as the primary hearing screen in newborns with no known hearing loss risk factors. Failure to show a strong OAE indicates that further testing or observation is necessary. OAE testing is frequently used as the initial screen within the ‘at risk’...
Page 71: Testing Options
Otoport OAE+ABR User Manual for Advance and Screener Testing options OTOPORT ADVANCE ONLY On the Test module screens, there are two options. The Quick button will enable you to choose a test type and perform a test before entering patient details. This option gives the user flexibility when testing conditions are variable.
Page 72 CHAPTER SEVEN Testing options The only option on the Multi-Test screen (Advance only) is to enter patient details or select a patient before testing. OTOPORT ADVANCE ONLY You will not be able to start a test if the Otoport is connected to a PC or charger.
Page 73: Patient Details
Otoport OAE+ABR User Manual for Advance and Screener Patient details Choose Select on one of the test module screens to view the Patient menu. After selecting or completing patient details, select Test. Select Save at the end of a Quick test to view the Save Options menu. After selecting a stored patient or saving details of a new patient, you will , Saving a test.
Page 74: Entering Patient Data
CHAPTER EIGHT Patient details History of last Select History Of Last to review test results of the last saved patient. This option will not function if there is no patient information stored on the Otoport. Find patient Select Find Patient to search for a patient with records already stored in the database.
Page 75 Otoport OAE+ABR User Manual for Advance and Screener Mandatory patient details The ID field is prefilled with a unique value and the name field prefilled with Auto. The prefilled values can be overwritten but the fields are mandatory and so the test cannot be saved if they are blanked. Beginning a test Select Test to enter the Test Choice screen.
Page 76: Beginning A Test
CHAPTER EIGHT Patient details Beginning a test Select Test to begin the OAE test once the correct patient details have been entered or Cancel to return to the Patient menu screen. Select test ear 8.2.1 The Select Ear screen represents the patient facing you. Press the right menu selection key or the right arrow key to select the Left Ear or press the left menu selection key or the left arrow key to select the Right Ear.
Page 77: Teoae Test
Otoport OAE+ABR User Manual for Advance and Screener TEOAE test TRAINING REQUIRED Transient Evoked OAE testing involves exposing the ear to a brief sound and recording the response from the cochlea. After choosing either the Quick option, or selecting Test on the patient details screen, the test choice screen is available.
Page 78: Teoae Checkfit
CHAPTER NINE TEOAE test TEOAE Checkfit Checkfit display 9.2.1 It is important to perform a test in the appropriate conditions. The Checkfit screen allows a user to assess the testing environment. Conditions such as high ambient noise, poor fit of the probe in the ear (including leaks) and blocked probes can be detected before starting the test.
Page 79 Otoport OAE+ABR User Manual for Advance and Screener Stimulus level indicator A Stimulus Level Indicator is shown in the centre of the Checkfit screen. With the probe in an ear, by default the device will attempt to adjust the stimulus to the set testing level. The indicator’s needle and the numeric display above the arc show the change in stimulus level during adjustment.
Page 80 CHAPTER NINE TEOAE test Ringing is displayed when there is obvious oscillation within the Stimulus Waveform after the initial positive and negative peaks instead of a flat line response. The table below describes the highlighted message which will appear if more than one condition is met.
Page 81 Otoport OAE+ABR User Manual for Advance and Screener Stimulus waveform display 9.2.2 Press the left/right arrow keys during Checkfit to access the Stimulus Waveform display. This shows a real time view of the stimulus waveform. With a good probe fit the waveform should have an initial large positive then negative peak followed by a flat line response.
Page 82: Teoae Recording
CHAPTER NINE TEOAE test TEOAE recording Following Checkfit, the OAE recording begins and data is collected and displayed on a choice of four test screens - two OAE histograms and two data tables. The screens are continually updated to give a real time representation of the OAE response.
Page 83 Otoport OAE+ABR User Manual for Advance and Screener Test condition information When conditions are good for data collection TE TEST will be shown at the top of the screen. This fades in and out to show that a test is currently running.
Page 84 CHAPTER NINE TEOAE test Response spectrum 9.3.2 The response spectrum screen shows the signal and noise levels recorded in 80Hz frequency bands. This is the information which is summarised by the half-octave histogram but the response spectrum displays the data at a much higher frequency resolution.
Page 85 Otoport OAE+ABR User Manual for Advance and Screener Response waveform 9.3.3 The response waveform screen displays the two interleaved OAE waveforms (named A and B). Waveform A is shown in white and waveform B in yellow. Waveforms that correlate well represent good quality recordings with low noise.
Page 86 CHAPTER NINE TEOAE test Data tables 9.3.5 During the test the two data tables are accessed by pressing the left/right arrow keys. The first data table displays the dB levels at the specified half octave frequencies. The following table describes each field: Field Description Signal...
Page 87 Otoport OAE+ABR User Manual for Advance and Screener The following table describes each field in detail: Field Description Units The total OAE Signal level dB SPL Noise The total Noise level dB SPL The amount of data accepted due to noise being below the noise reject level The amount of data rejected due to noise being above the noise reject level...
Page 88: Teoae Test Results
CHAPTER NINE TEOAE test TEOAE test results The following table lists all possible test results and gives an explanation of the circumstances under which each result would be shown. Test Result Description TE SNR OK The data collected has met the criteria set. The optimum test setting will depend on your application e.g.
Page 89: Dpoae Test
Otoport OAE+ABR User Manual for Advance and Screener DPOAE test OTOPORT TRAINING ADVANCE REQUIRED ONLY Distortion Product OAE testing involves presenting two continuous pure tones of different frequencies (f1 and f2 where f2 = 1.22 x f1). Distortion is produced by the cochlea and is measured at a third frequency (2f1-f2). After choosing either the Quick option, or selecting Test on the patient details screen, the test choice screen is available.
Page 90 CHAPTER TEN DPOAE test If only one DP mode is On in the Test Setup area (see chapter ), the test choice screen will not appear and the test will start immediately. Standard DPgram tests are performed at half-octave resolution. The frequencies presented depend on the test setup (see chapter );...
Page 91: Dpoae Checkfit
Otoport OAE+ABR User Manual for Advance and Screener DPOAE Checkfit 10.2 Checkfit display 10.2.1 It is important to perform a test in the appropriate conditions. The Checkfit screen allows a user to assess the testing environment before starting the test. Excessive noise or a poor probe fit may mean that it is not possible to record OAEs.
Page 92 CHAPTER TEN DPOAE test If there is a disagreement between the size indicated and the ear canal size expected of your patient then there may be a problem with the probe or the probe fit. For example: an indication of a large ear canal in a neonate may occur if the probe has fallen out of the ear;...
Page 93 Otoport OAE+ABR User Manual for Advance and Screener Stimulus waveform display 10.2.2 Press the left/right arrow keys during Checkfit to access the Stimulus Waveform display. The Stimulus Waveform shows a real time view of the stimulus waveforms produced by each of the stimulus channels. Channel A is shown in white and Channel B in yellow.
Page 94 CHAPTER TEN DPOAE test The stimulus spectrum should be a smooth, rounded curve. A jagged stimulus response in the low frequencies or a sharp peak in the mid- frequency range indicates a poor probe fit. Dips in the stimulus spectrum may be caused by standing waves in the ear canal.
Page 95: Calibration
Otoport OAE+ABR User Manual for Advance and Screener Calibration 10.3 Before starting the test the Otoport will calibrate the levels of the tones which are to be used in the test. This is necessary to account for the acoustic properties of the patient’s ear canal. If the required levels cannot be reached then the Otoport will display the message Unable to calibrate.
Page 96: Dpoae Recording
CHAPTER TEN DPOAE test DPOAE recording 10.4 Following Calibration, the OAE recording begins and data is collected and displayed on a choice of test screens - an OAE DP-Gram and data tables. The screens are continually updated to give a real time representation of the OAE response.
Page 97 Otoport OAE+ABR User Manual for Advance and Screener If no data has been collected at any given frequency then no histogram will be drawn and a diamond symbol will appear instead. If at a particular frequency the environmental noise level is high during data collection, no good data will be collected at that frequency and the diamond symbol may remain for a number of loops.
Page 98 CHAPTER TEN DPOAE test The following table describes the test condition information which appear if more than one condition is met: Consistent Stimulus Highlighted High Noise Out of Range Message DP TEST Check Probe Fit Noisy Check Probe Fit Cancel and End Select Cancel at any time during a test to pause the test.
Page 99 Otoport OAE+ABR User Manual for Advance and Screener The following table describes each field: Field Description The stimulus levels recorded at the frequencies f1 and f2 L1 and L2 in dB SPL. L1 or L2 values shown in grey indicate that the Target level is displayed The signal level recorded at the distortion product frequency (2f1-f2) for the specified test frequency in dB SPL...
Page 100 CHAPTER TEN DPOAE test Note that reaching the minimum valid signal level indicates only that the signal recorded is valid for processing, not that the DPOAE level at that frequency is normal or that it meets the signal to noise requirement set for the test.
Page 101 Otoport OAE+ABR User Manual for Advance and Screener The following table describes each field in detail: Field Description ΣOAE The sum of OAE Signal level at all DP frequencies (Pa sum converted to dBSPL) The number of 80ms data samples accepted due to noise being below the noise reject level The number of 80ms data samples rejected due to noise being above the noise reject level...
Page 102 CHAPTER TEN DPOAE test Test stop reasons 10.4.4 When Stop criteria have been met, the test will stop automatically and a single beep will sound for a positive OAE result or a double beep for a negative OAE result. When the test stops a result graphic is displayed on the screen (example below).
Page 103: Dpoae Test Results
Otoport OAE+ABR User Manual for Advance and Screener DPOAE test results 10.5 The following table lists all possible test results and associated graphics. The table gives an explanation of the circumstances under which each result would be shown. Test Result Description DP SNR OK The data collected has met the criteria set.
Page 104: Dp Growth
CHAPTER TEN DPOAE test DP Growth 10.6 DP growth tests produce measurements that are not used in other OAE tests. These are derived from the fitting of a straight line to the DPOAE levels recorded during the sequence of test stimuli. DP Growth data table 10.6.1 DP Thresh...
Page 105 Otoport OAE+ABR User Manual for Advance and Screener Slope This is the rate of growth of DPOAE with increase in L2. SLOPE has been related to the quality of the cochlea. A low (shallow) SLOPE and a high “dB at 80” value being indicative of good cochlear health. Units: μPa/dB or dB/dB dB at 80 This is a predicted level of DPOAE obtained by extrapolating the data to...
Page 106 CHAPTER TEN DPOAE test DP Growth graph 10.6.2 The DPG graph shows the DPOAE levels recorded at each of the six intensity levels presented. The x-axis shows the target L2 levels (45-70dBSPL). The y-axis shows the DPOAE level recorded in uPa or dBSPL depending on the test setting (see chapter Test set-up).
Page 107: Abr Test
Otoport OAE+ABR User Manual for Advance and Screener ABR test TRAINING REQUIRED The Auditory Brainstem Response (ABR) test records the electrophysiological response of the auditory system to sound. Select ABR Test from the scrolling modules using the arrow keys. After choosing either the Quick option, or selecting Test on the patient details screen, the test choice screen is shown.
Page 108: Impedance Check
CHAPTER ELEVEN ABR test Impedance check 11.2 The Otoport checks the quality of the connection between the skin and each of the three electrodes. This takes 2-3 seconds. A low impedance provides a good connection. Achieving optimum electrode impedance requires practice and experience. The Otoport also checks the noise levels, marked TN and PN on the screen.
Page 109 Otoport OAE+ABR User Manual for Advance and Screener If the test still does not start automatically, observe the two noise bars TN (EEG Noise), and PN (Powerline Noise). They may be high. For advice on how to reduce the noise see section ABR test problems.
Page 110 CHAPTER ELEVEN ABR test Further advice on ... Otoport impedance measurements The impedance of each electrode, Forehead (+ve), Nape (-ve) and Common are shown in the Impedance Check panel. Green circles are displayed for all impedance values where testing is possible.
Page 111 Otoport OAE+ABR User Manual for Advance and Screener Further advice on ... Electrical noise indicators The bars on the left of the screen indicate the electrical noise levels. The lower the test noise the more rapidly an ABR response will be detected. Electrical noise has multiple sources: •...
Page 112: Abr Checkfit
CHAPTER ELEVEN ABR test ABR Checkfit 11.3 The test stimulus in ABR tests can be provided either by applying an ear cup to the ear and inserting the probe into the ear cup or by inserting the probe directly into the ear, as for OAE testing. Which option is used, and how the probe checkfit functions, depends on the Ear Cups setting in Test Setup (see chapter Ear Cup mode set to On...
Page 113 Otoport OAE+ABR User Manual for Advance and Screener The ear icon shown below indicates that the Otoport is in Ear Cup mode. Ear Cup mode set to Off With Ear Cups set to Off, Checkfit proceeds as for OAE tests (see section for details).
Page 114: Abr Test
CHAPTER ELEVEN ABR test ABR test 11.4 During the test the Otoport plays a series of clicks into the ear and records the electrical response from the sensors (electrodes). The ABR signal is very small and difficult to distinguish from other electrical signals. The ABR test screen shows progress towards the detection of an ABR response.
Page 115 Otoport OAE+ABR User Manual for Advance and Screener Data summary 11.4.1 The Fsp is a measure of the likelihood that a response is present (see Eberling C., Don M. Scand Audiol 1984;13:187-197). Template correlation (TC) is a measure of the similarity of the current waveform to a template constructed from the responses of 30 neonates aged 0 to 6 weeks.
Page 116 CHAPTER ELEVEN ABR test Waveform display 11.4.2 This screen shows the averaged ABR waveforms collected. Two waveforms are collected from interleaved averages so that the correlation between the two can be assessed. The screen shows both of the interleaved waveforms (in yellow and orange) and the average of the two (in white).
Page 117 Otoport OAE+ABR User Manual for Advance and Screener Impedance monitoring 11.4.4 During the test, if progress towards ABR detection is slow, the impedance levels are automatically checked in the background. • If impedance levels are low, the test will continue. •...
Page 118 CHAPTER ELEVEN ABR test ABR test results 11.4.7 The following table lists all possible test results and associated graphics. The table gives an explanation of the circumstances under which each result would be shown. Test Result Description ABR Pass The data collected has met the criteria set. The optimum test setting will depend on your application, e.g.
Page 119 Otoport OAE+ABR User Manual for Advance and Screener High Mains Noise Interference from electrical equipment prevented the test from passing. The Fsp pass threshold was elevated due to this interference and the Fsp did not reach this higher threshold. High Impedance The electrode impedances measured at the end of the test were high and may have prevented an ABR from being recorded.
Page 120: Bilateral Abr Testing
CHAPTER ELEVEN ABR test Bilateral ABR testing 11.5 Bilateral ABR tests automatically run tests on both ears in sequence, right ear then left ear. Ear cups are recommended for bilateral testing and both ears should be prepared before testing commences. The current test ear is indicated during the test by a blue or red icon on the test screen.
Page 121 Otoport OAE+ABR User Manual for Advance and Screener When the right ear is completed the test result will be displayed briefly before testing on the opposite ear starts. When both tests are complete, stop reason icons for both ears will be shown on the screen together.
Page 122: Saving A Test
CHAPTER TWELVE Saving a test Saving a test TRAINING REQUIRED When a test is completed, select Save to save the result (the display will vary depending on the type of test performed). Select Cancel to discard the result; a confirmation screen is provided which gives the option to restart the test at Checkfit.
Page 123: Test Review Screens
Otoport OAE+ABR User Manual for Advance and Screener Test review screens 12.1 When the test record has been saved to the database the test screens are displayed again to allow for further review of the data collected. The left/ right arrow keys can be used to toggle between the test screen choices. Select Retest to repeat the test.
Page 124: Multi-Test
CHAPTER THIRTEEN Multi-Test Multi-Test OTOPORT ADVANCE ONLY The Multi-Test function allows a sequence of tests to be run automatically. It can be used to run a number of different tests on the same ear, for example: a TEOAE test followed by a DPOAE test or to run the same test repeatedly on the same ear (in order to monitor changes in the response over time).
Page 125 Otoport OAE+ABR User Manual for Advance and Screener Select Resume to continue multi-test, select Yes to finish testing or select Lock to set the Otoport to ignore any further keypad input until the test is complete (see Multi-Test Config section ).
Page 126: Records
126 CHAPTER FOURTEEN Records Records Records menu 14.1 Select Find to search for saved Patient Records within the database. Select Work List to edit or add a new patient to the Worklist. The Worklist can be reviewed and a patient selected to test. Select Summary for information on the current records in the database.
Page 127: Find Patient
Otoport OAE+ABR User Manual for Advance and Screener Find patient 14.2 The Otoport provides powerful database search facilities. The Find Patient screen gives the option to search and filter the Patient Records by specific criteria. Enter characters to filter for patients by ID, Family name, First name or Mother’s name.
Page 128 128 CHAPTER FOURTEEN Records Patient list 14.2.1 The Patient List will display Patient Records that meet the search criteria or will list all the patients in the database if no search criteria were specified. The Patient List displays patients alphabetically from the Family name field and also shows the patient ID.
Page 129: Test Summary
Otoport OAE+ABR User Manual for Advance and Screener Test summary 14.2.2 TRAINING REQUIRED When reviewing Results, a summary of each of the patient’s tests is given on screen. The diagrams on the next page detail all features of the Test Summary screens.
Page 130 130 CHAPTER FOURTEEN Records TEOAE test summary screen Patient’s family Current test of total name Test mode number of tests Test result Set stimulus level Ear tested R (Right) or L (Left) Band pass indicators showing which ½ octave bands Total OAE signal achieved their Stop level (dB SPL)
Page 131 Otoport OAE+ABR User Manual for Advance and Screener DP Zoom test summary screen Patient’s family Current test of total name OTOPORT number of tests ADVANCE ONLY Test type Set stimulus level Test result Lowest frequency tested Ear tested R (Right) or L (Left) Highest frequency tested ID of user who...
Page 132 132 CHAPTER FOURTEEN Records ABR test summary screen Patient’s family Test type name No. of Test saved to Test Result the patient record Ear Tested R (Right) or L (Left) Stimulus level Test progress Pass criteria indicator User ID Time of Test Test duration Date of Test...
Page 133 Otoport OAE+ABR User Manual for Advance and Screener Detailed test review 14.2.3 TRAINING REQUIRED Test Results can be reviewed in detail by choosing Select on the Test Summary screen. The OAE test data is shown on various test screens. Please refer to chapters for a full description of the screen displays for the relevant test type.
Page 134 134 CHAPTER FOURTEEN Records Review patient details in database 14.2.4 A non-editable version of highlighted Patient Details can be reviewed by selecting Detail in the Patient List. Please refer to chapter Patient Details for a full description of the screen format. Select Test to start the test for this patient.
Page 135: Work List
Otoport OAE+ABR User Manual for Advance and Screener Work list 14.3 The Work List facility allows for Patient Details to be entered and saved prior to the test, to reduce data entry time during the testing session. Select Add Patient to add a new patient to the work list. Select View Work List to review, edit or test a patient on the current Work List.
Page 136 136 CHAPTER FOURTEEN Records Once the correct patient details have been entered select Save to add the patient to the Work List or select Cancel to return to the Work List Menu screen and discard entered data. A warning will appear if the patient added to the Work List is already present in the Otoport database.
Page 137 Otoport OAE+ABR User Manual for Advance and Screener Review patient details in work list 14.3.3 Selecting Detail on the Work List screen displays the selected Patient Details in a non-editable format. Select Test to run a test on this patient. Please refer to chapter TEOAE Test or DPOAE Test for an explanation on how to setup and perform a...
Page 138: Database Summary
138 CHAPTER FOURTEEN Records Erase work list 14.3.4 The complete Work List can be deleted by selecting Erase work list. Database summary 14.4 A database Summary can be accessed from the Records Menu screen. It details the present number of Patients and Tests saved to the database. The Otoport can store up to 1024 patient records and over 5000 test results.
Page 139: Erase All
Otoport OAE+ABR User Manual for Advance and Screener Erase all 14.5 The Erase all function will delete all tests stored in the database. It is then necessary to confirm the erase request to help eliminate accidental deletion. Select Yes to Erase all tests or No to leave the records stored on the Otoport.
Page 140: System Menu
Select Controls to adjust Volume, Brightness and timing of the Backlight. Select Battery to view current battery status. System Details displays information for Otodynamics engineers. Select About for Otoport firmware revision number and issue date and device identification numbers. Select Back to return to the System module screen.
Page 141: Controls Menu
Otoport OAE+ABR User Manual for Advance and Screener Controls menu 15.2 Select Volume to increase or decrease the unit’s volume level or to turn sound off. Select Brightness to adjust the brightness of the screen for varying light conditions. Select Backlight to configure the status of the screen and keypad backlights.
Page 142 CHAPTER FIFTEEN System Brightness 15.2.2 The screen Brightness can be altered by pressing the left/right arrow keys. Select Save to accept the adjusted Brightness level. Select Cancel to ignore changes and return to the Controls Menu. Backlight 15.2.3 Use the left/right arrow keys to toggle between the Backlight control choices for the screen and keypad.
Page 143: Battery
Otoport OAE+ABR User Manual for Advance and Screener Battery 15.3 The Battery screen provides information on the current battery status. The total Battery Power remaining is displayed as a percentage and as an approximate operation time. The calculated time is only an approximate indication as the power requirements will vary depending on the mode of operation.
Page 144: System Details
Select Condition to condition the Otoport battery. See chapter Otoport power for more information. System details 15.4 System Details displays information for Otodynamics engineers. The device performs electrical self-checks and any errors during these tests are displayed (see section in Troubleshooting for further details). 25.3 About 15.5...
Page 145: Management
Otoport OAE+ABR User Manual for Advance and Screener Management Management menu 16.1 Select Users to add a New User or to review and edit the current User List. Select Facility & Risk to enter custom Facility or Risk Factor options. Select Date &...
Page 146: Users Menu
CHAPTER SIXTEEN Management Users menu 16.2 Select Add New User to enter details of a new user and save to the User List. Adding users to the Otoport allows test results to be attributed to individuals and allows password control of areas such as test setup. Select View Users to review, edit or delete users from the current User List.
Page 147 Otoport OAE+ABR User Manual for Advance and Screener Field Description Max No. Characters Name User’s name that appears at Login User ID The user’s unique identification (capitalised only) This is attached to a test record when saved to the database Password An alphanumeric password required for secure login.
Page 148 CHAPTER SIXTEEN Management Default Location, Facility and NICU options can be set for each user. On future login by the user, the Patient Details for each new patient will switch to these default options. If a test is not being performed in the normal testing location the default options can be easily changed when entering Patient Details.
Page 149 Otoport OAE+ABR User Manual for Advance and Screener Edit user 16.2.3 Select Edit to alter the details of a highlighted user. Select Save to save changes to the user’s details and return to the User List. Select Delete to remove the selected user from the User List. A confirmation message will appear at the top of the screen.
Page 150 CHAPTER SIXTEEN Management Login 16.2.4 The Otoport provides the option of User Login. When Login is switched on, the Login screen will appear automatically following device switch on. Check that the correct User name is displayed. The Otoport will remember the last user of the device and automatically default to that user at the next login.
Page 151: Facility And Risk
Otoport OAE+ABR User Manual for Advance and Screener Facility and risk 16.3 Select Facility to edit the name of the hospitals or clinics where the device is commonly used. Select Risk Factors to view or customise the list of 15 patient risk factor choices available.
Page 152 CHAPTER SIXTEEN Management Risk factors 16.3.2 The Risk Factors screen allows a user with Administrator access to modify the list of 15 risk factors available. The name chosen to identify each risk factor should be no longer than 12 characters. Select Save to save changes to the Risk Factors list and return to the Defaults Menu screen.
Page 153: Date And Time
Otoport OAE+ABR User Manual for Advance and Screener Date and time 16.4 The date and time set on the device can be altered in the Date & Time screen. The Otoport displays the time in a 24-hour format. When the Date field is highlighted press the right arrow key to access the calendar pop-up table.
Page 154: Other Options
CHAPTER SIXTEEN Management Other options 16.5 Other Options are available to customise the use of the device within a specified testing environment. ID Input 16.5.1 The ID Input choice bar can be used to alter the input format of the Patient’s ID field.
Page 155 Otoport OAE+ABR User Manual for Advance and Screener Device ID 16.5.3 The Device ID is a six-letter device identifier. This could be used to give simple identification of a unit if multiple units are used in one site, for example using colours to code such as yellow, blue etc. The Device ID will be saved to each test record so it cannot be changed until all data has been downloaded from the database and the database has been cleared.
Page 156: Test Set-Up
CHAPTER SEVENTEEN Test set-up Test set-up TRAINING REQUIRED Test setup menu 17.1 The Otoport provides comprehensive test configuration settings to enable you to tailor the device to specific testing requirements. Flexible programmable Stop criteria control the device’s OAE/ABR detection logic, where the device will automatically end the recording when the criteria have been met.
Page 157 Otoport OAE+ABR User Manual for Advance and Screener Select TEOAE or DPOAE to view the TE or DP test modes. OTOPORT ADVANCE ONLY OTOPORT ADVANCE ONLY Modes which are On will be available for selection at the start of test. Modes which are Off will not be available.
Page 158: Edit Mode Menu
CHAPTER SEVENTEEN Test set-up Edit mode menu 17.2 OTOPORT ADVANCE ONLY The mode selected for edit is displayed at the top of the screen. The available parameters depend on the mode type (ABR, TE, DP or DP Zoom) selected. Choose the section to edit then Select. It is not possible to edit the ABR, TE or DP factory modes.
Page 159: Teoae Test Config
Otoport OAE+ABR User Manual for Advance and Screener TEOAE test config 17.4 Field Description TE mode name User settable mode name Range: 8 characters max Stim level Peak target stimulus level for testing Range: 70-90 dB pe Stim range Stimulus OK range – the permitted change in stimulus level during TEOAE testing before probe movement warnings are provided.
Page 160 CHAPTER SEVENTEEN Test set-up Max NLo This is a test timeout function, which stops the test when the specified number of low noise data samples (when the noise present is below the reject level) has been collected. Range: 10-990 Max time The maximum time the test will run before automatic stop.
Page 161 Otoport OAE+ABR User Manual for Advance and Screener When Norms is set to On a pop up table enables configuring of Low and High norms for each frequency test point. Use the up/down arrow keys to select the parameter to edit and to move between the Low and High columns and left/right arrow keys to edit the settings.
Page 162: Dpoae Test Config
CHAPTER SEVENTEEN Test set-up DPOAE test config 17.5 OTOPORT ADVANCE ONLY Field Description DP mode name User settable mode name Range: 8 characters max Stim L1 Target stimulus level for f1 frequencies for testing Range: 50 to 75 dBSPL Stim L2 Target stimulus level for f2 frequencies Range: 50 to 75 dBSPL Noise reject...
Page 163 Otoport OAE+ABR User Manual for Advance and Screener Field Description Time/Point Sets the time spent at each point before changing frequency. Setting a low Time/Point enables results across a range of frequencies to be obtained rapidly. Whenever the test frequency is changed there is a brief pause in data collection.
Page 164 CHAPTER SEVENTEEN Test set-up DP Growth test config 17.5.1 OTOPORT ADVANCE ONLY The sequence of stimulus levels delivered during a DP Growth test is important and will greatly affect the growth function obtained. The sequence of L2 stimulus levels used in DP Growth tests are pre-set. The sequence of L1 levels are set by the parameters Max L2=70 L1 and Step L2 = -5 L1.
Page 165 Otoport OAE+ABR User Manual for Advance and Screener The two settings together determine the levels (L1 and L2) at which the tones (F1 and F2) are presented. For example if Max L2=70 L1 70 and Step L2 = -5 L1 -5 then the levels presented would be: Alternatively if Max L2=70 L1 67 and Step L2 = -5 L1 -2 then the levels presented would be:...
Page 166: Abr Test Config
CHAPTER SEVENTEEN Test set-up ABR test config 17.6 Field Description Mode name User settable mode name Range: 8 characters max Stim type Stim type sets the stimulus type used in the ABR test. The types available are ‘click’ and ‘chirp’. See chapter Mode of operation for further details of these stimulus types.
Page 167: Stop Criteria
Otoport OAE+ABR User Manual for Advance and Screener Stop criteria 17.7 The test stop logic is controlled in this section. Up and down arrows on the screen indicate that other fields are available, but not currently visible. Use the up/down arrow keys to scroll up and down the settings and highlight a parameter to edit.
Page 168 CHAPTER SEVENTEEN Test set-up TEOAE Stop criteria Field Description Min NLo The minimum number of low noise data samples (when the noise present is below the reject level) required for autostop that has to be collected. Range: 10 to 222 Min OAE sig The minimum total OAE signal level required.
Page 169 Otoport OAE+ABR User Manual for Advance and Screener DPOAE Stop criteria OTOPORT ADVANCE ONLY Field Description Min DP Loops Minimum number of completed frequency cycles from the highest to the lowest test frequency points. Manual operation is not available until this criterion is met. Averaging for less than two loops may increase the chance of an artefact being recorded.
Page 170 CHAPTER SEVENTEEN Test set-up Notes: The SNR calculated is dependent on the noise mode used (see chapter DPOAE test config). 17.5 On the test histogram a dot will appear above a bar if the DP at that frequency has met minimum signal and SNR criteria. If SNR and Signal levels at a frequency are met, but min NLo is not, the Otoport will not autostop.
Page 171 Otoport OAE+ABR User Manual for Advance and Screener DPOAE Growth Display Logic Field Description Min DP Loops Minimum number of completed frequency cycles from the highest to the lowest test frequency points. Manual operation is not available until this criterion is met. Range: 2 to 50 or off Min Band Sig Minimum signal at each point required for a tick to be...
Page 172 CHAPTER SEVENTEEN Test set-up ABR Stop criteria 17.7.3 Pass criteria Pass criteria sets the conditions in which the ABR test will give a pass result. Pass criteria is based on a statistical measure similar to signal to noise ratio known as Fsp, and a measure of the extent to which the averaged response waveform resembles a typical neonate ABR, a value referred to as template correlation (TC).
Page 173 Otoport OAE+ABR User Manual for Advance and Screener When to use each PC PC1 is ideal for performing an ABR test on adult subjects and is the default setting for ABRcustom mode. It is useful for training, demonstration and clinical investigations. PC2 is designed for neonate screening and is the default setting for the ABRscreen mode.
Page 174: Automation
CHAPTER SEVENTEEN Test set-up Automation 17.8 The Otoport has programmable automation logic to enable the user to configure the test routine to their preference. The test process can be set to be fully automated or manually operated, depending on the desired control over the test.
Page 175 Otoport OAE+ABR User Manual for Advance and Screener Auto Stop With Auto Stop On, the test will stop when the Stop criteria are met. With Auto Stop Off, the test will timeout in accordance with the maximum NLo figure (amount of data accepted into the result, when the noise present is below the reject level) set in Test Config.
Page 176 CHAPTER SEVENTEEN Test set-up DP automation 17.8.2 OTOPORT ADVANCE ONLY Auto Start With Auto Start On, the stimulus level calibration will automatically begin and the test will commence automatically. The device will check if the probe fit is stable and will not calibrate or start the test until a good probe fit is obtained.
Page 177 Otoport OAE+ABR User Manual for Advance and Screener NSE Smart NSE Smart enables more efficient testing by skipping points that have already achieved an acceptably low noise level so that test time can be spent on other points that are still contaminated by noise. With NSE Smart On, any point which has a noise level below the level set is skipped.
Page 178 CHAPTER SEVENTEEN Test set-up ABR Automation 17.8.3 Auto Start If Auto Start is ON then the ABR test will proceed from the Impedance Check screen to data collection (autostart) without any action from the tester if test conditions are good. If Auto Start is OFF the tester determines when to proceed from Impedance Check to data collection (manual start).
Page 179: Oae Other Settings
Otoport OAE+ABR User Manual for Advance and Screener OAE Other settings 17.9 The Other Settings area is not available in DP Zoom or DP Growth tests. Mandatory 17.9.1 The Mandatory save setting controls whether tests started have to be saved. This option may be useful if you would like to save all tests performed.
Page 180 CHAPTER SEVENTEEN Test set-up Environmental noise is normally greatest at low frequencies while the TEOAE signal is normally strongest in the middle frequencies. This means that filtering out low frequencies reduces noise levels more than OAE signal levels making it easier to record OAEs in noisy environments. There is also some advantage in filtering high frequencies.
Page 181: Abr Other Settings
Otoport OAE+ABR User Manual for Advance and Screener ABR Other settings 17.10 Neonate mode 17.10.1 With Neonate mode On the user is warned if the response from the probe indicates a large ear canal. This provides an additional check of probe fit for users who are testing only babies.
Page 182 CHAPTER SEVENTEEN Test set-up Use the arrow keys to choose 50Hz or 60Hz then press Select. You will be prompted to confirm whether to ‘Always use this setting?’: Select No if you are unsure of this setting and wish to leave ABR mains Not Set.
Page 183: Multi-Test Config
Otoport OAE+ABR User Manual for Advance and Screener Multi-Test config 17.11 OTOPORT ADVANCE ONLY The Multi-Test function allows a sequence of tests to be run automatically. Up to four different test modes may be selected and this set of tests may be repeated a number of times.
Page 184: Test Setup Defaults
1.6kHz are reduced so this mode should not be used if frequency specific information is required. The mode is similar to that used in the Otodynamics Echocheck. OAE1 mode is designed for general clinical TEOAE measurement in the range 1-4kHz. Users manually start and end the test. At test end three...
Page 185 Otoport OAE+ABR User Manual for Advance and Screener OAE2 is a replication of the settings used for the Universal Newborn Hearing Screening Programme in England. It is similar to OAE1 but requires only two half-octave bands for a pass and does not included 1kHz among possible pass bands.
Page 186 CHAPTER SEVENTEEN Test set-up DPG Modes OTOPORT ADVANCE ONLY Growth Pa uses optimised stimulus levels and a uPa scale so that DP threshold can be estimated. Growth dB uses equal stimulus levels and a dB scale. ABR Modes The ABR Screen mode is intended for newborn hearing screening. The default setting is 40dBHL, but you should set this level according to your screening program.
Page 187 Otoport OAE+ABR User Manual for Advance and Screener Notes: The Otoport OAE+ABR dynamically adjusts the delivered sound pressure level to achieve the selected normal hearing level (nHL) for each test. The instrument will achieve the selected dBnHL in all sizes of ear including, for screening levels (30-45dBnHL), adult ears up to the volume of a neonate screening ear cup.
Page 188 CHAPTER SEVENTEEN Test set-up TEOAE Test Setup Parameters Mode Name Screening OAE 1 OAE 2 Factory (locked) TE Test Config Stim Level 84dB pe 84dB pe 84dB pe 84dB pe Stim Range ± 1dB ± 1dB ± 1dB ± 1dB Noise Reject 52dB SPL 52dB SPL...
Page 189 Otoport OAE+ABR User Manual for Advance and Screener DPOAE Test Setup Parameters Mode name Screening High Factory OTOPORT (locked) ADVANCE ONLY DP Test Config Stim L1 Stim L2 Noise Reject Noise Mode Rapid Standard Standard Standard Time/Point 0.64s 0.64s 0.64s 0.64s Freq Range 1.5-8k...
Page 190 CHAPTER SEVENTEEN Test set-up DPOAE Zoom (DPZ) Test Mode Parameters Mode Name High OTOPORT ADVANCE DP Test Config ONLY Stim L1 Stim L2 Noise Reject Noise Mode Standard Standard Time/Point 0.32 0.32 Max time Norms DP Stop Criteria Min DP Loops Min Band Sig -5dB SPL -5dB SPL...
Page 191 Otoport OAE+ABR User Manual for Advance and Screener DP Growth (DPG) Test Mode Parameters Mode Name Growth Pa Growth dB OTOPORT ADVANCE DP Test Config ONLY Max L2 = 70 L1 Step L2 = -5 L1 Noise Reject Noise Mode Standard Standard Time/Point...
Page 192 CHAPTER SEVENTEEN Test set-up ABR Test Setup Parameters Mode Name Screen Custom ABR Test Config Stim Type Chirp Chirp Stim Level 40dBHL 45dBHL Max NLo 10240 10240 Max time 600 sec 600 sec ABR Automation Autostart Autostop ABR Stop Criteria Pass Criteria ABR Other Setting Mandatory...
Page 193 Otoport OAE+ABR User Manual for Advance and Screener Transfer (printing and downloading) Test results can be printed on the optional Otoport mini-printer or downloaded to PC for printing, archive or export. Wireless (via Bluetooth) and wired (via supplied cables) connections are available for both functions.
Page 194: Wired Downloading
CHAPTER EIGHTEEN Transfer Bluetooth download requires that Otolink software is installed and that your Otoport is paired with your PC. The password for pairing is 4679. See your Otolink manual for full instructions. When the connection to the PC is ready to send data the PC-Load text on the Otoport screen is green: If the connection is not complete then the PC-Load text on the Otoport screen is black.
Page 195: When You Can Print And Download
Otoport OAE+ABR User Manual for Advance and Screener When you can print and download 18.3 The Otoport provides flexible options to print or download from various areas of the user interface, including at the end of the test, from the patient database and via a dedicated menu.
Page 196: Transfer Menu
CHAPTER EIGHTEEN Transfer To print or download patient details and the result of a specific test, select the Results summary screen, scroll through the different tests for the patient (using the up and down arrow keys) and select Print or PC-Load, or Select the test details and then Print or PC-Load.
Page 197 Otoport OAE+ABR User Manual for Advance and Screener Transfer options 18.4.3 Bluetooth Bluetooth sets how the Otoport’s wireless communication will be used. If Bluetooth is set to PC-Load then the Otoport can use Bluetooth communication to send test results to a PC. Details of how to set up wireless download to PC are included in your Otolink manual.
Page 198 CHAPTER EIGHTEEN Transfer Print type There are two printing formats provided on the Otoport - Summary and Detailed. The Summary format prints core patient details and the test summary screen. The Detailed format (right) prints all the test screens and a fuller set of patient details. Example printout shown is of a TEOAE test.
Page 199: The Printing Process
Otoport OAE+ABR User Manual for Advance and Screener The printing process 18.5 If you are using the wired printing method ensure the printer is connected to the Otoport using the printing cable provided. Connect the flat connector to the Otoport with the arrows facing upwards and the square connector to the back of the printer.
Page 200 CHAPTER EIGHTEEN Transfer When a print is initiated, the Otoport will establish communication with the printer. The screen Searching for Printer will be displayed. The printout will then commence. The screen will display Printing during the print process. Select Cancel to terminate the printout. When the printout is completed, the screen from which the print was initiated will be displayed.
Page 201 Otoport OAE+ABR User Manual for Advance and Screener If there is a problem connecting to the printer using the wireless method, the following screen will be displayed providing options to Cancel, search for an alternative (Alter.) or Retry. To Retry the print, ensure the printer is switched on and is within range (5m).
Page 202: Printer Fault Detection
CHAPTER EIGHTEEN Transfer Printer fault detection 18.6 The printer can detect if the paper roll has run out, or if the lid is open. Under these circumstances the Otoport will report the printer is out of paper and the following message will be displayed. The printer will store (spool) the print job and flash the green light during this process.
Page 203: Printer Light Summary
Otoport OAE+ABR User Manual for Advance and Screener Printer light summary 18.7 The light at the front of the printer has a number of colour combinations, which indicate various conditions: Constant green: Normal operation, running on battery power Flashing green: The printer is storing print information (spooling) that cannot be printed at the time (e.g.
Page 204: Paper
CHAPTER EIGHTEEN Transfer Paper 18.8 When the printer is switched on, the key provides a paper feed function. A double press of the key will initiate a test print. The printer is supplied with spare paper rolls. To change the printer roll, pull the lid release catch (1) forwards with your thumb and the paper roll lid will spring open.
Page 205: Charging The Printer
Otoport OAE+ABR User Manual for Advance and Screener Charging the printer 18.9 TRAINING REQUIRED To charge the printer, plug the charger into a mains outlet socket and insert the charger jack plug into the rear of the printer. The light on the printer will flash green/orange to show the printer is on charge.
Page 206: Changing The Battery
Fit the battery pack ensuring wires (4) are not trapped. Slide back the battery compartment cover and replace the screw. Important Note: Only charge the printer if it contains an approved battery pack, supplied by your dealer or Otodynamics Ltd.
Page 207: Scanning
Otoport OAE+ABR User Manual for Advance and Screener Scanning Scanning facility 19.1 As well as the standard data entry method using the keypad, the Otoport provides two optional methods for data entry using scanners. The scanning methods are designed to reduce testing session times by making the patient data entry method efficient.
Page 208 CHAPTER NINETEEN Scanning The Otoport will show a Scanning screen. When the barcode is read successfully a beep will sound and the barcode number will populate the required field. Select Cancel to abort the scan. RFID scanning 19.2.2 This method scans radio frequency identification (RFID) chips, which can hold enough alphanumeric data for a complete patient data record on the Otoport.
Page 209: When To Use The Scanners
Otoport OAE+ABR User Manual for Advance and Screener When to use the scanners 19.3 Entering patient details 19.3.1 Select Scan when on the Enter details screen to populate the patient details. Make further edits manually with the keypad. Then continue to either test or save the result as normal. At login 19.3.2 In order for a user to login using the scanning method it is necessary...
Page 210 CHAPTER NINETEEN Scanning To login using a scanner, select Scan on the login screen. The Otoport will automatically login the user with their appropriate access rights and present the Test main menu.
Page 211: Qa Area Menu
Otoport OAE+ABR User Manual for Advance and Screener QA area QA area menu 20.1 The probe menu provides system functional checks which should be conducted weekly or if a fault is suspected. Probe test Select Probe Test to check the calibration performance of a probe. QA test history Select QA Test History to review previously performed system checks.
Page 212: Probe Test
Otoport system and new Probe Test results saved as a baseline reference. On selecting Probe Test the message Place Probe into Otodynamics Test Cavity. Press OK to begin test will appear on screen. Remove the tip from the probe and place the cavity on a flat surface. Insert the probe into the test cavity at a 90 degree angle to the top of the cavity, between the screws, as shown below left.
Page 213 Probe Test, by selecting Retest, ensuring the ear piece is firmly inserted in the test cavity. If the test continues to fail there may be a fault with the probe or system. Contact your dealer or Otodynamics for advice.
Page 214 It may be possible for the probe calibration to be adjusted if the probe is returned to Otodynamics. Noisy There was significant noise during the calibration test. This noise may have influenced the levels recorded so a Retest should be performed.
Page 215 Otoport OAE+ABR User Manual for Advance and Screener Dual probe result If two probes are connected to the Otoport, both are tested and a test result for each is shown: The full test result for either can be selected when Detail is selected and a probe icon will show which probe result is displayed.
Page 216 CHAPTER TWENTY QA area Pass - Tick/Check mark (P) – The NEW and OLD (stored) data for each of the two channels are within ± 3dB and are within the absolute limits. Query - Question mark (?) - Values differ by more than ± 3dB. The NEW and OLD levels are highlighted.
Page 217: Abr Cable Test
Otoport OAE+ABR User Manual for Advance and Screener ABR cable test 20.3 The ABR cable test checks the continuity of the electrode cables. Attach the probe snaps to the top of the cable tester as illustrated. Select ABR Cable Test and wait for the result to be displayed. If the electrode cables are OK then a large tick is displayed on the screen.
Page 218 CHAPTER TWENTY QA area QA test menu 20.4 OTOPORT ADVANCE ONLY When a QA test is selected the user will have the choice between a DPOAE and a TEOAE test (Advance only). Each QA type tests for different types of probe fault. As the TE QA only exercises one of the two output channels it is important that DP QA tests are used if DP data is to be recorded.
Page 219 On selection of Cavity Test from the QA Tests Menu and either TEOAE or DPOAE, the message Place Probe into Otodynamics Test Cavity. Press OK to begin test will appear on screen. Follow the instructions in Probe test for inserting the probe into the test cavity.
Page 220 Electromagnetic interference is an ‘invisible’ source of noise, so if there are persistent problems and other hardware issues have been eliminated, try to move to another location to perform the tests. Contact your dealer or Otodynamics for further advice.
Page 221 Otoport OAE+ABR User Manual for Advance and Screener If the result Cavity OK is displayed when the test stops, the test has passed. Save the test and perform the other QA tests if required or exit the QA Tests Menu screen. On selecting Save, Patient Details are automatically entered and the test is allocated a unique date/time stamp.
Page 222 CHAPTER TWENTY QA area Occlusion test 20.4.2 If the probe coupler is not fitted correctly, sound may leak between the probe loudspeaker and microphone. The Occlusion Test helps to check that the probe is assembled and is performing correctly. On selection of Occlusion Test from the QA Tests Menu and either TEOAE or DPOAE, the message Block Coupler Tube ends with Finger.
Page 223 Otoport OAE+ABR User Manual for Advance and Screener Test Result Description Artefact? If one band has > 6dB SNR and an absolute signal level > -5 dB SPL in acceptable conditions OR if two or more bands have greater than 3dB SNR with an absolute signal level >...
Page 224 CHAPTER TWENTY QA area If the result persists, contact your dealer or Otodynamics for further advice. On selecting Save, Patient Details are automatically entered and the test is allocated a unique date/time stamp. Patient Details Field Occlusion Test Default Name...
Page 225 Otoport OAE+ABR User Manual for Advance and Screener Real ear test 20.4.3 Testing with a known good ear checks that the Otoport correctly detects OAE responses. On selection of Real Ear Test from the QA Tests Menu and either TEOAE or DPOAE, the message Place Probe into an appropriate Ear.
Page 226 If a Real Ear OK result still cannot be achieved and if the resources are available, a recording should be performed with a different probe or with a different Otoport to help identify the problem. If the problem persists, contact your dealer or Otodynamics.
Page 227 Attach electrode cables to ABR cable tester will be shown. Attach the probe snaps to the top of the cable tester as illustrated below then press OK. Then the message Place Probe into Otodynamics Test Cavity. Press OK to begin test will is shown.
Page 228 Contact your dealer or Otodynamics for further advice. If the result Cavity OK is displayed when the test stops, the test has passed. Save the test and perform the other QA tests if required or exit the QA Tests Menu screen.
Page 229: Probe And Service Accessories
Otoport OAE+ABR User Manual for Advance and Screener Probe, tips and accessories Probe and service accessories 21.1 Your kit will include either a TEOAE or DPOAE probe, with appropriate sample coupler tubes and spare probe body/lid, depending on the Otoport model purchased.
Page 230 CHAPTER TWENTY-ONE Probe, tips and accessories Place the probe cable in the slot and release the plunger. The position of the clip on the cable can be adjusted if necessary. Open the crocodile clothing clip. Attach the probe cable clip to the patient’s clothing. If the cable slips through the grip, turn the head to grip the cable.
Page 231: Probe Tips
User Manual for Advance and Screener Probe tips 21.3 Samples of either TEOAE or DPOAE tips are provided with your instrument. Further supplies may be obtained from your distributor or from Otodynamics. TEOAE tips 21.3.1 (for probe supplied with Otoport Screener) REF T-T3E...
Page 232 CHAPTER TWENTY-ONE Probe, tips and accessories DPOAE+TEOAE probe tips 21.3.2 (for probe supplied with Otoport Advance) R5.8B R4.8S REF T-R5.8B REF T-R4.8S Fits ~5.8mm ear canal Fits ~4.8mm ear canal Most newborns Small newborns R6.8B REF T-R6.8B REF T-R7M Fits ~6.8mm ear canal...
Page 233 21.3.3 TRAINING REQUIRED All Otodynamics probe tips are disposable and MUST be discarded after each test. The probe coupler tubes should be visually examined for signs of contamination and the outer parts cleaned with an antiseptic wipe. Take care not to squeeze any cleaning fluid into the tubes.
Page 234: Probe Care
REQUIRED Cleaning 22.1 Otodynamics does not recommend the use of bleaches such as sodium hypochlorite based cleansers. The following is the suggested method of cleaning an Otodynamics probe. It should be noted that the probe is a precision assembly and, as such, care should be taken throughout in its handling and cleaning.
Page 235 Otoport OAE+ABR User Manual for Advance and Screener Disassembling the probe 22.2.1 First, unplug the probe from the instrument. Remove the tip and then the lid (fig. 1). Remove the coupler tubes by pushing the end of the tubes down onto a hard surface (fig. 2). Pull out the tubes by gripping them (fig. 3).
Page 236: Probes Safety Note
Probe care Probes safety note 22.3 Probes are designed for use with an Otodynamics disposable tip. Use of a tip is essential. Use without a tip will expose the ear canal to the hard plastic sound tubes and this might cause injury.
Page 237: Care Of The Otoport
Other than the probe ear piece and cable, the Otoport hardware should not come into contact with the patient being tested. Otodynamics probe tips are disposable and for single use only. A new tip should be used for each ear tested.
Page 238 CHAPTER TWENTY-THREE Care of the Otoport any sign of debris that may have entered them. Replace any part of the Probe care for details) probe ear piece as necessary. (See chapter Ensure your hands are cleaned thoroughly between each patient tested. Clean the Otoport each day before a testing session, or according to local requirements.
Page 239: Otoport Power
Initial charge 24.2 The Otoport is fully charged before it leaves the Otodynamics factory. However, the battery will discharge slowly, even if the device is switched off. It is therefore recommended that an initial charge is provided to fully...
Page 240: Standby
CHAPTER TWENTY-FOUR Otoport power Standby 24.3 To save power, the Otoport will go into standby mode after 90 seconds of inactivity. The Otoport will not go into standby if a test is being performed. If the Otoport goes into standby with a test result that has not been saved, then a beep will sound for five seconds in every minute to alert the user.
Page 241: Battery Charge
Otoport OAE+ABR User Manual for Advance and Screener Battery charge 24.4 When the Otoport is switched on, the opening screen shows a battery indicator which displays the remaining level of battery charge. The indicator has 7 segments which convey the total Battery Charge remaining.
Page 242 CHAPTER TWENTY-FOUR Otoport power Low battery 24.4.1 When the battery power reaches less than 10% remaining a Low Battery warning message will be displayed. This equates to approximately 30 minutes of testing time. Select OK to accept the message and return to the previous screen.
Page 243: Charging The Otoport
Otoport OAE+ABR User Manual for Advance and Screener Charging the Otoport 24.5 TRAINING REQUIRED It is recommended that when the Otoport is not in use, it is placed in the Docking Station, which should be plugged into the mains electricity supply, thereby ensuring that the Otoport is always fully charged and ready for use.
Page 244 CHAPTER TWENTY-FOUR Otoport power Connecting the Otoport to the charger cable 24.5.1 Switch off the Otoport prior to charging. Connect the mains lead to the charger, plug the mains lead into a power socket and switch on the power. The green light on the charger will illuminate indicating it is powered.
Page 245 Otoport OAE+ABR User Manual for Advance and Screener Additional charge indicators 24.5.2 There are additional charge indicators on the side of the Otoport. Power light - The green light above the plug symbol shows that the device is powered. Charging light - The orange light above the battery symbol will illuminate when the device is being charged.
Page 246 CHAPTER TWENTY-FOUR Otoport power Disconnecting the Otoport 24.5.3 If the cable has release keys, squeeze to disconnect, otherwise just pull out the cable. The power light will extinguish on the Otoport and if the Otoport was off prior to the charging session, the screen will return to blank. If on during the charging session the current screen will remain displayed.
Page 247: Conditioning The Otoport Battery
Otoport OAE+ABR User Manual for Advance and Screener Conditioning the Otoport battery 24.6 In order maintain the Otoport batteries and keep them at optimal performance you should condition the battery once per year, or if the unit batteries appear to run down more quickly than expected. This process involves completely discharging the battery and then fully charging the device.
Page 248: Troubleshooting
CHAPTER TWENTY-FIVE Troubleshooting Troubleshooting Otoport lock-up 25.1 In the unlikely event of an Otoport lock-up and it is not possible to control the device, turn the unit off and switch it on again. If this is not possible, hold down the On/off power key for 10 seconds; this will force the unit to switch off.
Page 249: System Details
25.3 The System main menu area includes System details. This screen provides information for Otodynamics engineers relating to the Otoport hardware. If your device is not functioning correctly or you suspect a fault, go to the System details menu and press the left or right arrow keys until the screen tittled Errs: is displayed.
Page 250: Instrument Fault Message
Run the probe checks (see chapter ). If the tests are ‘OK’ the device is functioning correctly and can be used for OAE testing again. If you receive the Instrument fault message again, contact your dealer or Otodynamics for support.
Page 251: Hardware Fault Messages
The Otoport should then be turned on and off a number of times to ensure that the error doesn’t reoccur. If you receive the hardware fault message again, contact your distributor or Otodynamics for support.
Page 252: Training
Training in the UK is provided by Otodynamics Ltd. Training elsewhere is via an approved dealer who has been trained by Otodynamics. Training on OAEs and use of the equipment may also be provided by previously trained staff and qualified audiologists.
Page 253: Obtaining Service
User Manual for Advance and Screener Obtaining service Otodynamics or its authorised distributor will replace or service, free of charge, this Otoport during the period of warranty, where the fault is not associated with misuse. Servicing after that period will be provided at reasonable cost.
Page 254: Calibration
Calibration Calibration The Otoport is a precision instrument designed to make accurate measurements of OAE and ABR responses. Before it leaves Otodynamics, each system supplied is calibrated using high quality acoustic measuring equipment traceable to national standards. Users should conduct the recommended weekly checks (see section ) to ensure the instrument is working correctly.
Page 255: Mode Of Operation
Otoport OAE+ABR User Manual for Advance and Screener Mode of operation TE Test 29.1 Parameter Description Stimulus Idle 80µs positive broadband square wave pulse with an intensity of 64dB pe (peak equivalent) in a 1cc cavity. Adjusted 80µs positive broadband square wave. Test 300µs biphasic broadband triangular pulse.
Page 256 CHAPTER TWENTY-NINE Mode of operation Signal and noise calculation Measures of signal and noise levels are based on the correlation and differences between waveforms A and B. Stimulus repetition rate One stimulus every 13ms, approximately 80 stims per second. Response window 3-13ms or 3-9ms after start of stimulus presentation.
Page 257: Parameter Description
Otoport OAE+ABR User Manual for Advance and Screener DP Test 29.2 OTOPORT ADVANCE ONLY Parameter Description Checkfit Stimulus Idle 80µs positive broadband square wave pulse with an intensity of 64dB pe (peak equivalent) in a 1cc cavity. Adjusted 80µs positive broadband square wave (intensity configurable) adjusted to 84dBpe.
Page 258: Abr Test
CHAPTER TWENTY-NINE Mode of operation ABR test 29.3 Stimulus level 5-60 dBHL Stimulus rate 51.8-57.9Hz Stimulus polarity Alternating Stimulus type Click or Chirp (see below) Stimulus repetition rate 51.8-57.9 Hz Evaluation method Fsp & Template Correlation Sampling rate 25.6 kHz Frame length 17.3-18.8ms Amplifier gain...
Page 259 Otoport OAE+ABR User Manual for Advance and Screener Stimuli description 29.3.1 Click stimuli: 80µS duration square pulse of alternating polarity. Chirp stimuli: 2.5ms duration of alternating polarity. The frequency dispersion of the chirp is defined by the delay at frequency T(f)= k * f^ with k=0.0920, and d=0.4356.
Page 260 CHAPTER TWENTY-NINE Mode of operation Hearing Level determination 29.3.2 The hearing threshold for these stimuli was determined in a group of 20 subjects with normal hearing aged <25. The stimuli were measured in a Brϋel & Kjær Ear Simulator Type 4157. The differences between the dBppSPL recorded in the B&K stimulator and the dBHL set on the Otoport were noted: Click dB...
Page 261 Otoport OAE+ABR User Manual for Advance and Screener Sensitivity of the Otoport OAE+ABR for ABR screening The sensitivity of the Otoport OAE+ABR for ABR screening was measured using 349 recordings from 30 neonates (3 days to 4 weeks old). The instrument was configured to deliver its short chirp stimulation at a level of 35dBnHL and at a rate of 52 per second.
Page 262 CHAPTER TWENTY-NINE Mode of operation Specificity 29.3.4 The specificity of an ABR hearing screening instrument quantifies the ability of the device to identify ears with normal hearing (the true negative rate). When there is no hearing loss we can assume that an ABR is present.
Page 263 Otoport OAE+ABR User Manual for Advance and Screener • Reduction of the stimulus level to 30dBnHL would decrease specificity to 95.5%, but increase the range of threshold elevations to which the instrument is sensitive. • Testing with a 60Hz powerline setting rather than 50Hz will have an no significant effect on specificity since the ABR response size change is minimal between 50 and 60 Hz stimulus rates (Less than 1dB).
Page 264: Response Detection
CHAPTER THIRTY Response detection Response detection OAE response detection is based on the Signal to Noise ratio (SNR) at each test frequency (for DPOAE tests) or across a specific frequency range (for TEOAE tests). Dependent upon the statistical nature of the noise, even with the probe in a cavity, there is a finite probability that data at the measurement frequency appears above the noise and will be considered as a ‘signal’...
Page 265 Otoport OAE+ABR User Manual for Advance and Screener Confidence for single frequency points 30.1.1 SNR required for single frequency Confidence Rapid (mean) Standard (mean +2sd) 10dB 99.9% 12dB 99.99% 16dB 10dB Note: Since diagnostic testing requires a high confidence of the OAE response at a single frequency, the standard noise mode is recommended.
Page 266 CHAPTER THIRTY Response detection Standard (mean +2 Std) based SNR values for four test points (e.g. 2-6kHz frequency range) Minimum SNR required Confidence 2 of 4 points 3 of 4 points 4 of 4 points 99.9% 99.99% Rapid (mean) based SNR values for six test points (e.g. 1-6kHz or 1.5-8kHz frequency range) Minimum SNR required Confidence...
Page 267: Confidence Levels In Teoae Tests
Otoport OAE+ABR User Manual for Advance and Screener Confidence levels in TEOAE tests 30.2 In the case of TEOAE measurements, data points are aggregated in to frequency bands. Normally this banding is performed as some proportion of octaves. Because of this logarithmic banding of data there is a frequency variance in the SNR required for any given level of confidence.
Page 268 (4-10ms). The SNR required for various confidence levels with these results are: Confidence Minimum SNR required for confidence level 99.9% 99.99% Note: All of the above data were derived empirically from laboratory studies using Otodynamics equipment in the presence of noise recorded from real clinics.
Page 269: Conclusions
Otoport OAE+ABR User Manual for Advance and Screener Conclusions 30.3 How to use this data in relation to OAE screening? 30.3.1 The test confidence percentage is a statistical indicator of how likely the test will correctly identify an ear with no OAE in response to the selected type and level of stimulus.
Page 270 CHAPTER THIRTY Response detection For example, with a birth rate 600,000 per annum, screening with TEOAE in a well-baby neonate population (assume 0.3% incidence), a screening protocol of 2 bands from 4 with a minimum 5dB SNR stipulation we could predict that the screening process would ‘miss’...
Page 271: Technical Specifications
90mm x 38mm x 28mm – Weight 120g Interfaces 31.1.2 Probe connector compatible with Otodynamics UGx probes (8 pin) Charging/Data connector - connects to Otodynamics PSU (charging) or to PC USB port (USB 1.1or 2.0) via Data Cable Bluetooth wireless print (option) RFID reader (option) Indicators 31.1.3...
Page 272 CHAPTER THIRTY-ONE Technical specifications Clock/Calendar 31.1.5 Internal Real Time Clock/Calendar operates to 2099 Power 31.1.6 Li-Polymer Battery Intelligent multi-level power control for charging/testing/idle/sleep/shutdown: After 1.5 minutes unit will enter sleep mode After 20 minutes in sleep mode unit will shut down Sleep time: 20 hours minimum (with fully charged battery) Running time:...
Page 273 Max 80% up to 31C decreasing linearly to 5% RH at 40C Otodynamics instruments and probes are calibrated at an ambient pressure of 101 kPa (standard atmospheric pressure at sea level). Lowering the ambient pressure significantly (e.g. when operating at altitude) alters the acoustic response of the probe.
Page 274 CHAPTER THIRTY-ONE Technical specifications Classifications and standards 31.1.11 Device Class 2a (Directive 93/42/EEC) BS EN ISO 13485:2003 (REF: EN46001 superseded 01/03/2004) ISO 14971: Application of risk management BS EN 60601-1: Medical Electrical Equipment Part 1: General Requirements for Safety BS EN 60601-1-1: Medical Electrical Equipment - Part 1: General Requirements for Safety - Collateral Standard - Safety Requirements...
Page 275: Electromagnetic Compatibility: Otoport
3.3m of the Otoport. The use of probes, chargers and connection cables other than those supplied by Otodynamics Ltd, and specifically for use with the Otoport may result in increased emissions or decreased immunity of the Otoport.
Page 276 CHAPTER THIRTY-ONE Technical specifications Guidance and manufacturer’s declaration – electromagnetic immunity The Otoport is intended for use in the electromagnetic environment specified below. The user of the Otoport should ensure that it is used in such an environment. Immunity test IEC 60601 Compliance Electromagnetic...
Page 277 Otoport OAE+ABR User Manual for Advance and Screener The following functions of the Otoport are deemed ‘essential performance’ and were tested for immunity in compliance with IEC60601-1-2: (a) The collection of Otoacoustic Emissions (OAEs) (b) The retention of user settings and test results...
Page 278 CHAPTER THIRTY-ONE Technical specifications Guidance and manufacturer’s declaration – electromagnetic immunity The Otoport is intended for use in the electromagnetic environment specified below. The customer or the user of the Otoport should ensure that it is used in such an environment. Immunity IEC 60601 Compliance...
Page 279 Otoport OAE+ABR User Manual for Advance and Screener Recommended separation distances between portable and mobile RF communications equipment and the Otoport The Otoport is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the Otoport can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Otoport as recommended below, according to the maximum output power of the communications equipment.
Page 280 (‘cellphones’) should not be operated within 10m of the Otoport OAE+ABR. The use of probes, electrodes, chargers and connection cables other than those supplied by Otodynamics Ltd, and specifically for use with the Otoport OAE+ABR may result in increased emissions or decreased immunity of the Otoport OAE+ABR.
Page 281 Otoport OAE+ABR User Manual for Advance and Screener Guidance and manufacturer’s declaration – electromagnetic immunity The Otoport OAE+ABR is intended for use in the electromagnetic environment specified below. The user of the Otoport OAE+ABR should ensure that it is used in such an environment.
Page 282 CHAPTER THIRTY-ONE Technical specifications The following functions of the Otoport OAE+ABR are deemed ‘essential performance’ and were tested for immunity in compliance with IEC60601-1-2: (a) The collection of Otoacoustic Emissions (OAEs) (b) The retention of user settings and test results...
Page 283 Otoport OAE+ABR User Manual for Advance and Screener Guidance and manufacturer’s declaration – electromagnetic immunity The Otoport OAE+ABR is intended for use in the electromagnetic environment specified below. The customer or the user of the Otoport OAE+ABR should ensure that it is used in such an environment. Immunity IEC 60601 Compliance...
Page 284 CHAPTER THIRTY-ONE Technical specifications Notes: 1 At 80 MHz and 800 MHz, the higher frequency range applies. 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. (a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
Page 285 Otoport OAE+ABR User Manual for Advance and Screener Recommended separation distances between portable and mobile RF communications equipment and the Otoport OAE+ABR The Otoport OAE+ABR is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the Otoport OAE+ABR can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Otoport OAE+ABR as recommended below, according to the maximum output power of the communications equipment.
Page 286: En60645-3 Conformance Notes
10kHz anti-alias filter, which ‘rounds’ any ‘sharp edges’. (b) Transducers and headband force: The stimulus is delivered to the patient’s ear using a UGS or UGD Otodynamics probe. The probe tip holds the probe ear piece in the ear canal, with no headband or other retaining device required.
Page 287 Otoport OAE+ABR User Manual for Advance and Screener Suppose, for example, that a stimulus level of 90dB is reported by the Otoport during stimulus setup (rectangular stimulus). If this stimulus was replaced by the reference stimulus, of the same amplitude, the level generated in a IEC 60711 ear simulator would be: 90dB + -6.1dB + 3.0dB = 86.9 dB SPL peak-to-peak equivalent.
Page 288: Abr Module
Probe connectors compatible with Otodynamics UGS and UGD probes (8 pin) Electrode connectors compatible with 1.5mm ‘Touchproof’ DIN 42-802 connectors Charging/Data connector - connects to Otodynamics PSU (charging) or to PC USB port (USB 1.1or 2.0) via Data Cable Indicators 31.5.3...
Page 289: Symbol Explanations
Otoport OAE+ABR User Manual for Advance and Screener Symbol explanations 31.6 Class II Type BF Bluetooth ® enabled RFID enabled Caution USB 1.1 When discarded, the item must be sent to separate collection facilities for recovery and recycling Probe socket Battery charging indicator Power supply connection Stimulus OK indicator...
Page 290 CHAPTER THIRTY-ONE Technical specifications Refer to operating instructions Otodynamics’ factory address Product catalogue number Product date of manufacture Product serial number RF transmitter Training required TRAINING REQUIRED...
Page 291: Index
Index Symbols ½ octave bands 82 Backlight 51 Barcode/RFID scanner 30 Barcode scanning 207 Battery 57 Beginning a test 75 About 144 Beginning a Test 76 ABR 20 Bilateral ABR testing 120 ABR Automation 178 Blue LEDs 52 ABR controls 33 Bluetooth wireless printing and ABR Mains 181 download 193...
Page 292 CHAPTER THIRTY-TWO Index Conditioning the battery 247 Confidence levels in DPOAE tests 264 Confidence levels in TEOAE tests 267 Ear canal size indicator 78 Connecting the electrodes 41 Ear cups 27 Connecting the probe 40 Edit mode menu 158 Consent 75 Edit user 149 Control buttons 48 Electrical interference 68...
Page 293 Half-octave histogram 82 Management 145 Hard reset 52 Mandatory patient details 75 Hardware fault messages 251 Mandatory save setting 179 Hardware ID 144 Menu selection buttons 29 Hardware options 272 Mic filter 179 Hardware processing and storage 272 Minimum recordable signal level 99 High EEG noise 119 Mode of operation 255 High impedance 119...
Page 294 CHAPTER THIRTY-TWO Index OAE 87 Real ear test 225 OAE Stop criteria 167 Records 126 OAE test problems 67 Regulatory marks 32 Occlusion test 218 Removing the Otocheck from the ABR On connect 198 Module 39 On/Off power button 29 Repair 253 Other options 154 Repeat 184...
Page 295 Stimulus LED 52 Time 87 Stimulus level indicator 79 Tips 231 Stimulus OK 29 Tip selection 61 Stimulus pattern 255 Too few bands 88 Stimulus repetition rate 256 Training 252 Stimulus spectrum 81 Transfer 196 Stimulus waveform 81 Transient Evoked OAE testing 77 Stop criteria 167 Types of otoacoustic emissions 12 Stop-Logic 87...
Page 296 CHAPTER THIRTY-TWO Index...

This manual is also suitable for:

Otoport oae+abr

Otodynamics Otoport Advance User Manual

Quick Links

Troubleshooting

Need help?

Questions and answers

Related Manuals for Otodynamics Otoport Advance

Summary of Contents for Otodynamics Otoport Advance

This manual is also suitable for:

Table of Contents