Page 1 Otoport User Manual for Otoport DP+TE models Including: DP Clinical, DP Clinical Flexi, DP+TE and Otoport Flexi Otoport OAE+ABR Otoport DP+TE models Issue 5...
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 © 2017 Otodynamics Ltd. All Rights Reserved. Otodynamics Ltd 30-38 Beaconsfield Rd Hatfield Herts AL10 8BB UK...
Page 3: Table Of Contents
Otoport OAE+ABR User Manual for Otoport DP+TE model Contents Introduction Intended use General guidance General use precautions Types of otoacoustic emissions OAEs and screening Auditory Brainstem Response Equipment identification Supplied only in Otoport OAE+ABR kit Supplied only in Otoport DP+TE kit Supplied in both kits Optional accessories Controls, indicators and connections...
Page 4 Switching On Switch on screen Logo screen Mode select Login Test choice Test preparation General checks before testing Environment checks for ABR Tip selection and probe fitting Electrode fitting Test troubleshooting OAE test problems ABR test problems Test selection Choose test type or worklist Patient details Select test ear Checkfit...
Page 5 Otoport OAE+ABR User Manual for Otoport DP+TE model ABR test Impedance check 10.1 Checkfit 10.2 Ear cup Checkfit 10.3 ABR test 10.4 Bilateral ABR testing 10.5 Saving the test Quick Save option 11.1 Patient details 11.2 Review 11.3 Last 11.4 Result 11.5 Link-Test...
Page 6 Printing and downloading Bluetooth wireless printing and download 16.1 Wired downloading 16.2 When you can print 16.3 The printing process 16.4 Printer fault detection 16.5 Printer light summary 16.6 Paper 16.7 Charging the printer 16.8 Changing the battery 16.9 Quality tests Probe test 17.1 ABR cable test...
Page 7 Otoport OAE+ABR User Manual for Otoport DP+TE model Power Battery life 21.1 Initial charge 21.2 Standby 21.3 Battery charge 21.4 Charging the Otoport 21.5 Conditioning the Otoport battery 21.6 Otoport OAE+ABR 21.7 Equipment troubleshooting Otoport lock-up 22.1 Switch on 22.2 System details 22.3 Instrument fault message...
Page 9: Introduction
Introduction This manual provides instructions for use for two compact, handheld instruments, the Otoport OAE+ABR (Otoport DP+TE models) and the Otoport DP+TE OAE system. This includes DP Clinical, DP Clinical Flexi, DP+TE and Otoport Flexi variants. Intended use This Otodynamics Otoport/Otocheck OAE+ABR device is indicated for use when there is a requirement to screen for hearing disorders by objective and non-invasive means.
Page 10: General Guidance
Configuration, section Pass criteria). OAE screening functions 15.2.4 include 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 Otoport DP+TE model General use precautions TRAINING REQUIRED Do not connect the patient to high frequency (HF) surgical equipment and to an Otoport in ABR mode simultaneously. Failure to observe this precaution may result in burns at the site of the electrodes and possible damage to the Otoport.
Page 12 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: Types Of Otoacoustic Emissions
Otoport OAE+ABR User Manual for Otoport DP+TE model Types of otoacoustic emissions Otoacoustic emissions are sounds which can be recorded in the ear canals of functionally normal ears. This Otoport can make two types of OAE measurements: Transient Evoked OAEs (TEOAEs) and Distortion Product OAEs (DPOAEs). The difference between the measurements is largely in the means used to generate and measure the emission, rather than in the source of the emission itself.
Page 14: Oaes And Screening
CHAPTER ONE Introduction 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’ population.
Page 15: Auditory Brainstem Response
Otoport OAE+ABR User Manual for Otoport DP+TE model Auditory Brainstem Response Auditory Brainstem Response (ABR) is an electrophysiological response that measures the auditory system’s response to sound. Three voltage sensors (electrodes) are placed on the patient and a sound probe is placed in the test ear.
Page 16: Equipment Identification
CHAPTER TWO Equipment identification Equipment identification Supplied only in Otoport OAE+ABR kit REF DTC+ABR Otoport DP+TE OAE+ABR REF ABR-EC1 Electrode cables - 1m REF ABR-EC2 Electrode cables - 2m REF ABR-SK Starter kit of electrodes pack, skin preparation gel and pack of cotton wool pads...
Page 17: Supplied Only In Otoport Dp+Te Kit
Otoport OAE+ABR User Manual for Otoport DP+TE model REF ABR-CAV Probe cavity and ABR cable tester REF ABR-INF Infection control sleeve for Otoport OAE+ABR unit only Shown fitted REF ABR-CAS Equipment case for Otoport OAE+ABR kit Supplied only in Otoport DP+TE kit REF DTC-S Otoport DP+TE REF OP-CAS...
Page 18: Supplied In Both Kits
CHAPTER TWO Equipment identification REF OAE-CAV Probe test cavity Supplied in both kits REF PR-UGD UGD DPOAE probe REF PR-POUCH Drawstring probe pouch REF PR-CLIP Probe cable clip...
Page 19 Otoport OAE+ABR User Manual for Otoport DP+TE model REF DPC DPC probe coupler tubes x 5 Re-order quantity: 10 or 100 REF BGD BGD probe body and lid x 1 Re-order quantity: 10 REF DP-BOX Sample probe tips See chapter 18 Probe, tips and accessories for re-order codes REF OP-CHG...
Page 20 CHAPTER TWO Equipment identification REF OTOLINK Otolink software CD REF OP-INF Infection control sleeve for Otoport only Shown fitted Documentation pack Includes instrument and software manuals, quickstart and probe use guides...
Page 21: Optional Accessories
Otoport OAE+ABR User Manual for Otoport DP+TE model Optional accessories REF ODS Docking station For use with Otoport DP+TE. Provides connections for printing, charging and downloading to PC REF OCC Charging cradle For use with Otoport DP+TE REF OMP-R Otoport printer Wired and wireless models available for Otoport DP+TE Wireless model available for...
Page 22 CHAPTER TWO Equipment identification Printer accessories and consumables 2.4.1 REF OMP-CAB-R Otoport printer cable For use with Otoport OAE device (not for use with ABR) REF OMP-CHG-R Otoport printer charger REF OMP-PAP-R Otoport printer paper rolls Quantity: 8 REF OMP-PAP-R Otoport printer self-adhesive paper rolls Quantity: 8...
Page 23: Controls, Indicators And Connections
Otoport OAE+ABR User Manual for Otoport DP+TE model Controls, indicators and connections Probe socket Stimulus OK (S) and Noise OK (N) indicators Display screen Menu selection keys Up/down/left/right navigation keys Data entry keypad On/Off power key Charging status indicators Speaker Charger and PC cable socket...
Page 24: Oae Labelling
21-11-16 TITLE: DETAILS ON THIS DRAWING ARE Otoport Product Label – International COPYRIGHTED AND MUST NOT BE REPRODUCED WITHOUT THE PRIOR (OLABL-0083-IEC) CONSENT OF OTODYNAMICS LTD. ISS. DATE D.C.N. CHECKED Class II electrical protection (double insulated) Type BF applied part...
Page 25 Otoport OAE+ABR User Manual for Otoport DP+TE model Manufacturer Serial Number The Otoport serial number comprises model code (DTC in this instance), year and month of manufacture (yymm) and unique manufacture ID (xxxx). The complete serial number is therefore DTC/yymmxxxx. Certification or regulatory marks 2.6.2 The label features one or more of the following certification/regulatory...
Page 26: Otoport Oae+Abr Controls, Indicators And Connections
CHAPTER TWO Equipment identification 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 27: Abr Labelling
ABR Sleeve Product Label 18-11-16 COPYRIGHTED AND MUST NOT BE REPRODUCED WITHOUT THE PRIOR International (OLABL-0085-IEC) DWG No: CONSENT OF OTODYNAMICS LTD. ISS. DATE D.C.N. CHECKED Refer to user manual Class II electrical protection (double insulated) Type BF applied part...
Page 28 The fields in the serial number are made up of the following parts: (01) Company prefix: Otodynamics, Item reference: Otoport DP+TE OAE+ABR (11) Production date: 31st January 2015 (21)
Page 29: Getting Started
Otoport OAE+ABR User Manual for Otoport DP+TE model 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’...
Page 30 CHAPTER THREE Getting started...
Page 31 Otoport OAE+ABR User Manual for Otoport DP+TE model 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.
Page 32: Removing The Otoport From The Abr Module
CHAPTER THREE Getting started 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. 3.2.2 Move the Otoport up to disconnect it from the port at the bottom of the 3.2.3...
Page 33: Connecting Probes And Electrodes
Otoport OAE+ABR User Manual for Otoport DP+TE model 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 34 CHAPTER THREE Getting started 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 35: Initial Charge
Otoport OAE+ABR User Manual for Otoport DP+TE model Initial charge Before using your Otoport for the first time, fully charge the unit. See chapter Otoport Power for details. Quickstart guides Quickstart guides for OAE and ABR tests, included as separate items in your document pack, are shown on the following pages.
Page 36 OAE QUICKSTART Otoport DP+TE 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...
Page 37 Select Right or Left ear. The size of the ear being An OAE histogram is tested is indicated by the continuously updated during graphic. Press to START. the test. to Retest the same The test result will be Press The test will auto-stop and a to Finish the displayed at the top of the patient or...
Page 38 NLO bar represents the test. button. o save the test, amount of data collected. press the button. 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.7 May 2017 0120...
Page 39: Using The Keys And Keypad
Otoport OAE+ABR User Manual for Otoport DP+TE model 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 40 CHAPTER THREE Getting started 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 41 Otoport OAE+ABR User Manual for Otoport DP+TE model 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 and down arrow keys.
Page 42 CHAPTER THREE Getting started Deleting characters 3.7.7 The bottom right hand key is used as a Delete or Contrast key. If the cursor is at the end of a row of characters, press this key to delete the last character. Left and right arrow keys can be used to scroll back through the text.
Page 43: Connecting The Probe To The Otoport
Otoport OAE+ABR User Manual for Otoport DP+TE model Connecting the probe to the Otoport 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.
Page 44: 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 45 Otoport OAE+ABR User Manual for Otoport DP+TE model 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 46: 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 on/off power key, the device will automatically turn off.
Page 47: Logo Screen
User Manual for Otoport DP+TE model 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 48: Mode Select
CHAPTER FOUR Switching on Mode select The Otoport DP+TE has two distinct operating modes: Screen and Clinical. The Screen mode is designed to run tests in the shortest possible time and to stop automatically when there is conclusive evidence that a response is present.
Page 49: Login
Otoport OAE+ABR User Manual for Otoport DP+TE model 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 and right arrow keys to choose the correct user name from the choice bar.
Page 50: Test Choice
CHAPTER FOUR Switching on Test choice Following the logo screen, or after successful login, the test screen for the last test used is displayed. From here you can view the Result for the last patient tested, edit the details for the Last patient tested or start a Test on a new patient.
Page 51 Otoport OAE+ABR User Manual for Otoport DP+TE model OAE+ABR model ABRcustom only available if configured (see chapter 15) See chapter Test selection for further information on choosing a test.
Page 52: 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 Otoport power for Ensure the Otoport is charged (see chapter information).
Page 53: Tip Selection And Probe Fitting
Otoport OAE+ABR User Manual for Otoport DP+TE model Tip selection and probe fitting Appropriate tip selection and good 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 DPOAE+TEOAE 18.3...
Page 54 CHAPTER FIVE Test preparation Fitting for newborns using ear cups 5.3.2 When using ear cups, there are two probe tips that you can use for the best fit of the probe to the ear cup. These are the T7M tip for TE probes and the R7M tip for DP probes;...
Page 55: Electrode Fitting
Otoport OAE+ABR User Manual for Otoport DP+TE model Electrode fitting Skin preparation 5.4.1 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 56 CHAPTER FIVE Test preparation Placement (montage) 5.4.2 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 57 Otoport OAE+ABR User Manual for Otoport DP+TE model 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 58: Test Troubleshooting
CHAPTER SIX Test troubleshooting 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. If a pass result is not obtained, remove the probe and inspect the probe tip.
Page 59: Abr Test Problems
Otoport OAE+ABR User Manual for Otoport DP+TE model 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 60 CHAPTER SIX Test troubleshooting 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 • repositioning the baby’s head High environment electrical noise 6.2.3 Audible noise in the room as well as interference from other electrical...
Page 61: Test Selection
Otoport OAE+ABR User Manual for Otoport DP+TE model Test selection TRAINING REQUIRED Choose test type or worklist OAE+ABR model ABRcustom only available if configured (see chapter 15) Using the left and right arrow keys, choose one of the test types. The available modes will depend on whether Screen or Clinical test mode was selected.
Page 62 CHAPTER SEVEN OAE test procedure The default Clinical modes are TEOAE, DP High, DP Low and DP 12 Frequency. The default Screen modes are TEOAE, DP Low and ABRscreen. Small icons indicate whether Screen or Clinical mode is in use. The Configuration).
Page 63: Patient Details
Otoport OAE+ABR User Manual for Otoport DP+TE model Patient details Patient details can be entered before testing by selecting Test (with Quick Save Off). Details can also be entered after the test by selecting Last, this is the only route for entering details if Quick Save is On. If you are retesting an existing patient then they can be selected, and their details viewed, from Records (see chapter A Date of Birth (D.O.B) and Gender may also be added for the patient.
Page 64: Select Test Ear
CHAPTER SEVEN OAE test procedure Select test ear 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 65: Checkfit
Otoport OAE+ABR User Manual for Otoport DP+TE model Checkfit 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 66 CHAPTER SEVEN OAE test procedure If the position of the Fit Size Indicator corresponds with the age of the patient and Checkfit is displayed on the top of the screen then the probe fit and the test conditions are adequate for testing. The Stimulus and Noise OK indicators (above the screen) should also be illuminated.
Page 67 Otoport OAE+ABR User Manual for Otoport DP+TE model The following table describes which highlighted message will appear if more than one condition is met. Note that highlighted messages also appear during the test. Consistent Stimulus Out Stimulus Highlighted High Noise of Range Ringing Message...
Page 68: Dpoae Test
CHAPTER EIGHT DPOAE test DPOAE test DP stimulus calibration Before starting the test the Otoport will calibrate the levels of the stimulus tones which are to be used in the test. By default, this process will start automatically following Checkfit, or if Start is selected. This is necessary to account for the acoustic properties of individual patients’...
Page 69: Dp Test Screen
Otoport OAE+ABR User Manual for Otoport DP+TE model DP test screen The initial test screen displayed depends upon the display option set from the Configuration menu (see chapter Configuration). Switch between the test screens by pressing the left or right arrow keys. The Otoport will remember the last screen displayed and return to it in the next test.
Page 70 CHAPTER EIGHT DPOAE test Line and Bar graphs 8.2.1 The two screens display the same test data graphically, either as a line graph or a bar graph. The blue dots or bars at each frequency show the DPOAE signal level and the red section represents the noise level in this frequency region.
Page 71 Otoport OAE+ABR User Manual for Otoport DP+TE model Circles 8.2.2 The display shows a series of small circles, each representing the SNR recorded at a particular DP frequency when the minimum signal level is met. If the minimum signal level is not met, the circle will not fill completely, even if SNR criterion has been achieved.
Page 72 CHAPTER EIGHT DPOAE test Data tables 8.2.4 During the test the data tables can be accessed by pressing right or left arrow keys. Data Table 1 displays the dBSPL levels of: The signal level recorded at distortion product frequency (2F1-F2) The average Noise level recorded at the corresponding DP frequency region (this value depends on the Noise Mode set - see chapter...
Page 73 Otoport OAE+ABR User Manual for Otoport DP+TE model Test condition information 8.2.6 When conditions are good for data collection DP TEST will be shown at the top of the screen and progress indicators will move either side of the title to show that a test is currently running.
Page 74: Test Stop Reasons
CHAPTER EIGHT DPOAE test Test stop reasons There are three possible ways in which a test can stop: AutoStop, Test Timeout and Manual End. When the test stops the data collected is assessed and a result is given as a graphic image and then written highlighted at the top of the test screen.
Page 75: Dpoae Test Results
Otoport OAE+ABR User Manual for Otoport DP+TE model DPOAE test results The following table lists all possible test results with the associated results graphic and gives an explanation of the circumstances under which each result would be shown. Test Result Description DPOAE Pass The data collected has met the criteria set.
Page 76: Teoae Test
Stim out of range will be displayed. The user then has the option to Continue or Cancel the test. In these circumstances Otodynamics recommends that the test is cancelled. Efforts should then be made to improve the probe fit, check the probe coupler tubes are clear and improve the test environment.
Page 77: Teoae Test Screen
Otoport OAE+ABR User Manual for Otoport DP+TE model TEOAE test screen During testing the Otoport plays a series of clicks into the ear and records the response. The OAE signal is very small and difficult to distinguish from the noise made by other sounds in the room and by the patient. The longer the Otoport records for, the easier it is to distinguish the OAE signal from the noise.
Page 78 CHAPTER NINE TEOAE test If either the OAE signal or noise level at a frequency band is greater than 20dB SPL, an up arrow will appear above the band to the right of the tick to show the level is off the graphical scale. If no data has been collected, then a histogram will not be drawn and diamond symbols will be shown instead.
Page 79 Otoport OAE+ABR User Manual for Otoport DP+TE model Infant distraction screens 9.2.3 These screens are designed to encourage young patients to keep still and quiet during OAE testing. They show a simple drawing that becomes more colourful if they are quiet. The quieter they are the more quickly the picture progresses.
Page 80 CHAPTER NINE TEOAE test Data tables 9.2.5 Two data tables may be accessed during the test by pressing right or left arrow keys. The first data table displays the dB levels at the specified half octave frequencies. Signal The signal level recorded in dB SPL Noise The Noise levels recorded in dB SPL The Signal-to-Noise Ratio (SIGNAL minus NOISE dB);...
Page 81: Test Stop Reasons
Otoport OAE+ABR User Manual for Otoport DP+TE model Test condition information 9.2.7 When conditions are good for data collection TE TEST will be shown at the top of the screen and progress indicators will move either side of the title to show that a test is currently running.
Page 82 CHAPTER NINE TEOAE test Pausing and cancelling the test 9.3.5 You may wish to pause a test for instance during periods of noise. When the test is paused, it is possible to cancel the test and discard the data. Select Cancel to pause the test. Select Yes to end the test and discard the data, No to resume the test and Checkfit to restart the test at the Checkfit stage.
Page 83: Teoae Test Results
Otoport OAE+ABR User Manual for Otoport DP+TE model TEOAE test results The following table lists all possible test results with the associated result graphic and gives an explanation of the circumstances under which each result would be shown. Test Result Description TEOAE Pass The data collected has met the criteria set.
Page 84: Abr Test
CHAPTER TEN ABR test ABR test TRAINING REQUIRED Use the left or right arrow key to choose your ABR test screen. Note: The ABR test can operate in different Modes. The following text refers to Screening Mode, where Autostart is ON. See section in the Configuration chapter for Mode configuration 15.2.4 option.
Page 85: Impedance Check
Otoport OAE+ABR User Manual for Otoport DP+TE model Impedance check 10.1 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.
Page 86 CHAPTER TEN ABR test 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. The test will start automatically when conditions are good.
Page 87 Otoport OAE+ABR User Manual for Otoport DP+TE model 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 88 CHAPTER TEN ABR test 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 89: Checkfit
Otoport OAE+ABR User Manual for Otoport DP+TE model Checkfit 10.2 The test stimulus in ABR tests can be provided either by inserting the probe into the ear, as for OAE testing, or by applying an ear cup to the ear and inserting the probe into the ear cup. Ear cups can be particularly useful in neonates with very small ear canals where a secure probe fit is not possible.
Page 90: Abr Test
CHAPTER TEN ABR test If Checkfit is selected, the device will go back into Checkfit and re-check whether ear cups are being used or not. If Yes is selected, the device will go into ear cup Checkfit as shown below. Ear Cup mode set to On The device will go straight to ear cup Checkfit without checking for ear cup use.
Page 91 Otoport OAE+ABR User Manual for Otoport DP+TE model The circle indicates the probability that an ABR response is present. The circle is filled when there is 99% confidence that a response is present. NLO is an indication of the amount of data which has been collected with the noise lower than the noise reject level.
Page 92 CHAPTER TEN ABR test NHi/NLo NLo shows the number of sweeps accepted into the average. NHi shows the number of sweeps rejected due to high electrical noise levels. Accepted Shows the number of sweeps accepted into the average. Rejected Shows the number of sweeps rejected due to high electrical noise levels. ABR Noise Shows the estimate of residual noise in the averaged response that is used in the Fsp calculation.
Page 93 Otoport OAE+ABR User Manual for Otoport DP+TE model Impedance monitoring 10.4.3 During the test, if progress towards ABR detection is slow, the impedance levels are automatically checked in the background. • If impedances are low, the test will continue. • If impedances are high, the test is paused and the ‘Impedance Check’ screen will be displayed.
Page 94 CHAPTER TEN ABR test Test stop reasons 10.4.6 There are five possible ways in which a test can stop, described below. When the test stops the data collected is assessed. The result is given as a pop-up graphic and written highlighted at the top of the test screen. The Otoport will beep once if a test has stopped with an ABR Pass result and will beep twice if the test has stopped with any other result.
Page 95 Otoport OAE+ABR User Manual for Otoport DP+TE model Test timeout If a test has not met the set pass criteria then the test will stop after 10240 sweeps have been collected, or after 10 minutes. Noise target reached If the residual noise in the averaged test (ABR Noise) becomes so low that any ABR present would already have been detected, then further testing is redundant, so the test is ended.
Page 96 CHAPTER TEN ABR test Poor Probe Fit The last stimulus level recorded changed from that recorded at the start of the test by >3dB, or the last acoustic noise level recorded was high. Stopped Too Soon The test has been ended manually before the minimum amount of data required had been collected.
Page 97: Bilateral Abr Testing
Otoport OAE+ABR User Manual for Otoport DP+TE model Bilateral ABR testing 10.5 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 98 CHAPTER TEN ABR test 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. It is not possible to review bilateral ABR tests in detail at the end of test.
Page 99: Saving The Test
Otoport OAE+ABR User Manual for Otoport DP+TE model Saving the test TRAINING REQUIRED Quick Save option 11.1 The options available from the test result screen depend on the Quick Save option (see chapter Configuration) Quick Save Off 11.1.1 If Quick Save is Off, select Save to Save the test result. Select Cancel to discard the test result.
Page 100 CHAPTER ELEVEN Saving the test Select PC Load or Print (the option available will depend on your setup (see ) to send the test result to the Otoport printer or to the PC. 15.4.4 Quick Save On 11.1.2 If Quick Save is On, the options after test are Retest, Cancel and Finish. Select Cancel to discard the test result.
Page 101: Patient Details
Otoport OAE+ABR User Manual for Otoport DP+TE model Patient details 11.2 The Enter details screen is displayed. The patient ID is filled with an automatically generated ID. If an ID is not required, this field may be used to enter notes. The Name field displays Auto. The user may save these details or overwrite them with alternative patient details.
Page 102: Review
CHAPTER ELEVEN Saving the test Review 11.3 After Saving the user is given the option to Print the test results, to Retest the same patient or to Finish and return to the main menu. Retest will start a new test of the same type for the patient. This can be used to retest the same ear or to test the opposite ear.
Page 103: Last
Otoport OAE+ABR User Manual for Otoport DP+TE model Last 11.4 After one ear has been tested, further tests can be added to the same patient record by selecting Last from the main menu. Patient details can be amended and tests printed using this function. From the Main Menu select Last.
Page 104 CHAPTER ELEVEN Saving the test The details stored can be edited by using the up/down buttons to locate the correct field and then entering the new data using the keypad. All fields except Location, Facility and NICU can be edited. When an edit has been made the screen will change: If you are happy with the changes you have made select Save.
Page 105: Result
Otoport OAE+ABR User Manual for Otoport DP+TE model Result 11.5 Select Result to review the tests results for the current patient. Select displays the detailed result for this test. Select Print to print this test result.
Page 106: Link-Test
CHAPTER TWELVE Link-Test Link-Test The Link-Test function allows a sequence of tests to be run automatically. It can be used to run all the tests currently available on the same ear (i.e. if all modes are set in Config as On, then it will run a TE, then a DP High, then a DP Low.
Page 107: Work List
Otoport OAE+ABR User Manual for Otoport DP+TE model Work List The Work List allows details for multiple patients to be entered into the Otoport prior to testing. This eliminates the need for data entry while with the patient, enabling faster, more flexible testing. To use the Work List, it must be turned on in the Config area (see chapter Access the Work List by using the left or right navigation keys from the main menu.
Page 108: Editing Details
CHAPTER THIRTEEN Worklist Complete the required details on the Patient Details screen. The ID/ Notes and Name fields are pre-filled but can be over-written. When details are complete select Save to save the details to the Work List, Test to run a test on this patient immediately or Back to discard these patient details.
Page 109: Deleting Patients
Otoport OAE+ABR User Manual for Otoport DP+TE model Deleting Patients 13.3 Scroll to the required patient. Select Delete to remove the patient from the Work List. Select Yes to confirm the deletion of the selected patient from the Work List. Select All to delete all of the patients from the Work List. Select No to return to the Work List without deleting any patient details.
Page 110: Utilities
CHAPTER FOURTEEN Utilities Utilities Select Record to see the Result of previous tests and to view the details of patients previously tested. Record also allows the user to select a previously tested patient for a new test. Records may only be deleted from within the Configuration area, via the System menu, from the Memory Status screen (see chapter Selecting Record presents the user with the list of patients tested.
Page 111: Patients Tested
Otoport OAE+ABR User Manual for Otoport DP+TE model Patients tested 14.1 The Patient list displays the Name and ID/Notes field for each patient. The Up and Down arrow indicators to the left show that there are other patient records not currently visible on screen. At the top of the screen, the total number of patients in the list and the position of the selected patient are displayed: 226/234 indicates that the highlighted patient is 226th in a list of 234 patients.
Page 112: Patient Details
CHAPTER FOURTEEN Utilities Patient details 14.2 The Patient Details screen allows the user to see the ID/Notes, Name, Date of Birth (DOB) and Gender stored for a particular patient. Selecting Test from this screen starts a new test, the result of which will be saved with the records of the selected patient.
Page 113: Summary Results
Otoport OAE+ABR User Manual for Otoport DP+TE model Summary results 14.3 TRAINING REQUIRED The test summary gives an overview of the test result. The diagrams following illustrate the features of test summary screens. The number of tests currently saved to the patient is displayed in the top right of the screen.
Page 114 CHAPTER FOURTEEN Utilities DPOAE test summary screen Test type Patient’s Name Test Result No. of Test saved to the patient record Ear Tested R (Right) or L (Left) Stimulus Levels Pass Criteria Band Pass Indicators (ticks) Total OAE signal showing which response frequency bands achieved their pass...
Page 115: Detailed Results
Otoport OAE+ABR User Manual for Otoport DP+TE model ABR test summary screen Test type Patient’s Name No. of Test saved to Test Result the patient record Ear Tested R (Right) or L (Left) Stimulus level Pass criteria Test progress indicator Test duration User ID Time of Test...
Page 116: Configuration
CHAPTER FIFTEEN Configuration Configuration TRAINING REQUIRED The Configuration menu is available from the Utilities screen. Select Quality Tests to check the performance of the probe or the ABR electrode cables. Select Test Settings to change test display and pass criteria. Select Date &...
Page 117: Test Settings
Otoport OAE+ABR User Manual for Otoport DP+TE model Test settings 15.2 Mode select 15.2.1 The test settings are divided into Screen and Clinical modes. The default Test Mode settings for each are listed at the end of this section ( 15.2.7 Defaults).
Page 118 CHAPTER FIFTEEN Configuration General 15.2.3 Use the arrow keys to navigate and choose between the setup options (described below). Select Save to apply the settings changes you have made and return to the Configuration screen. Select Cancel to discard changes made to settings and return to the Configuration screen.
Page 119 Otoport OAE+ABR User Manual for Otoport DP+TE model Neonate mode 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. The warning message is displayed after Checkfit and before the test starts.
Page 120 Tests will take longer than the Rapid mode and the confidence level of the result will exceed that needed for screening. Otodynamics does not recommend the Rapid mode for clinical measurements as the dBSPL accuracy may not be sufficient to quantify changes over time.
Page 121 Otoport OAE+ABR User Manual for Otoport DP+TE model ABR mains ABR mains sets the ABR test configuration for optimum test recording in mains (powerline) noise. The mains frequency varies in different countries. Set 50Hz if the mains in your region is 50Hz and 60Hz if your region is 60Hz.
Page 122 CHAPTER FIFTEEN Configuration TEOAE 15.2.4 The TE Quick setting is used to switch the TE mode on (default) and off. When on, the mode will provide a Quickscreen click stimulus of 84dB. If it is set to off, this test mode will not be available. Mode Mode sets the pass criteria for screening.
Page 123 Otoport OAE+ABR User Manual for Otoport DP+TE model The fixed and configurable test parameters are summarised in the following tables: Configurable test parameters Name Any 2 Any 3 Any 4 Wide Narrow Min pass bands None None Min total (wide band) SNR None None...
Page 124 CHAPTER FIFTEEN Configuration Norms TE Norms are set and displayed in the same way that DP Norms are set. Start With start mode set to On (default), the testing will proceed from Checkfit to Test as soon as the Otoport detects a stable probe fit, without the need for the user to select Start.
Page 125 Otoport OAE+ABR User Manual for Otoport DP+TE model DPOAE 15.2.5 The Otoport DP+TE has three different DPOAE test modes, DP High, DP Low and DP 12 Freq. Choose the mode you wish to edit from the menu. DP Levels Configuring Levels sets two DP stimulus pairs (L1 and L2), which are available for selection prior to test.
Page 126 CHAPTER FIFTEEN Configuration If either mode is set to Off then this mode will not be available for selection from the main menu. Mode Mode sets the pass criteria for screening. The Any 2 Bands, Any 3 Bands, Any 4 Bands and Any 5 Bands settings require a 6dB SNR and a minimum signal level of -5dBSPL in each of the stated number of half octave frequency bands to meet the pass criteria.
Page 127 Otoport OAE+ABR User Manual for Otoport DP+TE model Norms Norms allows the user to set the expected range of OAE response levels. This range is then marked on the DP-gram or bar-chart screen during tests as a visual aid. Setting Norms does not affect any pass criteria that has been set. Pass criteria are based on signal-to-noise ratios and are intended for screening applications or for data quality control.
Page 128 CHAPTER FIFTEEN Configuration Freq range The frequency range tested may be selected with the left and right arrow keys. 1.5-8k tests at six F2 frequencies: 1.5, 2, 3, 4, 6 and 8kHz 1-6k tests at six F2 frequencies: 1, 1.5, 2, 3, 4 and 6kHz 2-6k tests at four F2 frequencies: 2, 3, 4 and 6kHz The frequency range for DP 12 Freq is fixed at 1-8kHz.
Page 129 Otoport OAE+ABR User Manual for Otoport DP+TE model 15.2.6 The Otoport OAE+ABR has two different ABR test modes, ABRscreen and ABRcustom. ABRscreen is optimised for the screening of neonates and is less configurable than ABRcustom. Choose the mode you wish to edit from the menu.
Page 130 CHAPTER FIFTEEN Configuration Association (ASHA) - Expert Panel Recommendations on Newborn Hearing Screening (2014). Some major infant screening programs use 40dBHL (e.g. in UK). Screening with stimulus levels above 40dBnHL will miss some mild hearing losses. In ‘ABRcustom’ mode the stimulus level can be set from 5-60dBHL in 1dB steps.
Page 131 Otoport OAE+ABR User Manual for Otoport DP+TE model 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. The chirp stimulus has been demonstrated to give a larger ABR response for the same stimulus level.
Page 132 CHAPTER FIFTEEN Configuration The two measures Fsp and TC are combined in four different ways as follows: PC1 requires: Fsp level exceeds the dynamic Fsp with no template requirement PC2 requires: Fsp level exceeds the dynamic Fsp and TC exceeds the minimum TC level PC3 requires: Fsp level exceeds the dynamic Fsp and TC exceeds the minimum TC...
Page 133 Otoport OAE+ABR User Manual for Otoport DP+TE model Test mode defaults 15.2.7 Screen Mode Clinical Mode General Display Circles Bars Neonate Nreject Variable Variable Extend Noise Mode Rapid Standard TEOAE TE Quick 84 dBpe 84 dBpe Mode Narrow Any2Bands Norms Start Stop DP High...
Page 134 CHAPTER FIFTEEN Configuration Screen Mode Clinical Mode DP 12 Freq DP Levels 65-55 Mode Any9Bands Any9Bands Smart Norms Start Stop Band SNR ABR Screen Stim Level 40 dBHL Pass Criteria Ear Cups Auto Auto ABR Custom Stim Level Pass Criteria Ear Cups Auto Auto...
Page 135: Date And Time
Otoport OAE+ABR User Manual for Otoport DP+TE model Date and time 15.3 The date and time set on the device can be altered in the Date & Time screen. Use the keypad to change the Time. When the Date field is highlighted press the right arrow key to access the calendar pop-up table.
Page 136: System
CHAPTER FIFTEEN Configuration System 15.4 The System screen allows users to view information on Memory Status, Controls, Battery power, System Information or to change the Setup. Memory status 15.4.1 The Otoport has the capacity to store up to 1,000 test records. The memory status screen displays the number of records currently stored and the percentage of memory still available.
Page 137 Otoport OAE+ABR User Manual for Otoport DP+TE model Controls 15.4.2 Volume The current Volume level is represented on the display by a number of shaded blocks. Use the Left/Right Arrow buttons to decrease or increase the Volume level. To turn the sound off press the left arrow key repeatedly until Sound Off appears in the centre of the display.
Page 138 CHAPTER FIFTEEN Configuration Brightness 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 Use the left and right arrow keys to toggle between the Backlight control choices for the screen and keypad.
Page 139 Otoport OAE+ABR User Manual for Otoport DP+TE model Battery 15.4.3 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 140 CHAPTER FIFTEEN Configuration Setup 15.4.4 Quick Save The options available from the test result screen depend on the Quick Save option. If Quick Save is On, test results can be saved from the test result screen with a single button push but patient details can only be entered after testing by selecting Last on the main menu.
Page 141 Otoport OAE+ABR User Manual for Otoport DP+TE model Auto Send If Auto Send is set to On then the test result is automatically printed/ downloaded after the test is saved. If Auto Send is set to Off then the user has the option to print/download the test after save.
Page 142 CHAPTER FIFTEEN Configuration Print type Print type controls the length and detail contained in the Otoport printout. The Summary format prints only core patient and test details. The Detailed format prints a fuller set of patient and test quality details (see section 16.2.3 On connect...
Page 143: Users
User Manual for Otoport DP+TE model System info 15.4.5 The System Info area provides information on the Otoport. System Details displays information for Otodynamics engineers (see System details for further details). chapter 22.3 The About screen provides information relating to the Otoport’s identification and mode of operation including the model variant name.
Page 144 CHAPTER FIFTEEN Configuration Select View Users to review, edit or delete users from the current User List. Select Settings to turn Login on or off. Select Back to return to the Configuration menu screen. Add New User 15.5.1 To add a New User, complete the field entries shown on the New User screen.
Page 145 Otoport OAE+ABR User Manual for Otoport DP+TE model View user list 15.5.2 The user list displays the Name, Password and Status of all users currently saved to the device. Select Back to exit the user list and return to the Users menu. If a user has been assigned Administrator rights, an A will be present in the right hand Status column of the table.
Page 146: Printing And Downloading
CHAPTER SIXTEEN Printing and downloading 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 147: Wired Downloading
Otoport OAE+ABR User Manual for Otoport DP+TE model 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 148: When You Can Print
CHAPTER SIXTEEN Printing and downloading When you can print 16.3 The Otoport provides flexible options to print from various areas of the user interface, including printing at the end of the test. Print settings are located under Configuration in System, Setup.
Page 149 Otoport OAE+ABR User Manual for Otoport DP+TE model Printing at the end of a test 16.3.1 When the OAE recording is finished and the result has been saved, select Print for a printout of the patient details and current test result or all the test results for the current patient, depending on the Otoport configuration (see chapter Printing or downloading from records...
Page 150 CHAPTER SIXTEEN Printing and downloading 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. Select PC-Load on the Utilities menu to download all new records for all patients and tests that haven’t previously been downloaded.
Page 151 Otoport OAE+ABR User Manual for Otoport DP+TE model Print type 16.3.3 There are two printing formats provided on the Otoport - Summary and Detailed. The Summary format (below left) prints core patient details and the test results. The Detailed format (right) prints all the test details and a fuller set of patient details.
Page 152: The Printing Process
CHAPTER SIXTEEN Printing and downloading The printing process 16.4 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 153 Otoport OAE+ABR User Manual for Otoport DP+TE model When a print is initiated, the Otoport will establish communication with the printer. The screen Connecting to Printer will be displayed. The printout will then commence. When the printout is completed the screen from which the print was initiated will be displayed.
Page 154: Printer Fault Detection
CHAPTER SIXTEEN Printing and downloading Select the printer required with the navigation keys and then Select. Printing will then commence. To cancel the printout, select the Cancel button. When your print has completed, pull the paper sharply towards you across the serrated tear bar to remove the printout and store it with your patient records.
Page 155: Printer Light Summary
Otoport OAE+ABR User Manual for Otoport DP+TE model Printer light summary 16.6 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 no paper, or printer lid open) Flashing green/orange...
Page 156: Paper
CHAPTER SIXTEEN Printing and downloading Paper 16.7 When the printer is switched on, the button provides a paper feed function. A double press of the button 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 157: Charging The Printer
Otoport OAE+ABR User Manual for Otoport DP+TE model Charging the printer 16.8 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 158: 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 159: Quality Tests
Otoport OAE+ABR User Manual for Otoport DP+TE model Quality tests Damage or malfunction of the Otoport, the probe or the cables can lead to errors in testing. To ensure that any faults are detected before they lead to faulty data collection, the following tests can be performed. Quality tests should be carried out on a weekly basis.
Page 160 Otoport system and new Probe Test results saved as a baseline reference. On selection of Probe Test the message Place Probe into Otodynamics Test Cavity. Press OK to begin test. will appear on screen. If two probes are connected, then the probe test will run automatically on both, so it is necessary to insert both into test cavities.
Page 161 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 162 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 163 Otoport OAE+ABR User Manual for Otoport DP+TE model Dual probe result If two probes are connected to the Otoport, then 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 164 164 CHAPTER SEVENTEEN Quality checks Details The full test result can be viewed by selecting Details. The details screen shows the levels recorded from the probe loud speaker at each frequency tested. The NEW column shows the levels just recorded and the OLD results are the levels that are stored in the probe.
Page 165: Abr Cable Test
Otoport OAE+ABR User Manual for Otoport DP+TE model ABR cable test 17.2 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 166: Cavity Test
If the resources are available repeat the test with a different test cavity and then with a different probe. This will identify which component is responsible for the problem. Contact your dealer or Otodynamics for further advice.
Page 167: Occlusion Test
Otoport OAE+ABR User Manual for Otoport DP+TE model Note: If a signal is detected in the test cavity, ensure that five successful cavity tests are performed on the Otoport before returning it to use. Refit the probe in the cavity between each test.
Page 168: Real Ear Test
• Try recording emissions from another subject. If you are still unable to achieve a Real Ear OK result then, if the resources are available try recording with a different probe or with a different Otoport. If the problem persists, contact your dealer or Otodynamics.
Page 169: Probe, Tips And Accessories
Otoport OAE+ABR User Manual for Otoport DP+TE model Probe, tips and accessories Probe and service accessories 18.1 Your kit will include a DPOAE probe with sample coupler tubes and spare probe body/lid. See chapter Equipment identification for details. Probe cable clip 18.2 The probe cable clip is provided to aid the practical aspects of positioning and securing the probe cable during OAE testing.
Page 170 CHAPTER EIGHTEEN 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 171: Dpoae+Teoae Probe Tips
REF T-R11M REF T-R13M Fits ~11mm ear canal Fits ~13mm ear canal Extra large adult ears Large adult ears Samples of each tip size are provided with your instrument. Further supplies may be obtained from your distributor or from Otodynamics.
Page 172 18.3.1 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 173: Probe Care
REQUIRED Cleaning 19.1 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 174 174 CHAPTER NINETEEN Probe care Disassembling the probe 19.2.1 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 175: Probes Safety Note
User Manual for Otoport DP+TE model Probes safety note 19.3 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 176: 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 177 Otoport OAE+ABR User Manual for Otoport DP+TE model Before fitting each tip, ensure the sound tubes are carefully examined for any sign of debris that may have entered them. Replace any part of the probe ear piece as necessary. (See chapter Probe care for details) Ensure your hands are cleaned thoroughly between each patient tested.
Page 178 Initial charge 21.2 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 179 Otoport OAE+ABR User Manual for Otoport DP+TE model Standby 21.3 To save power, the Otoport will go into standby mode after 1.5 minutes of inactivity. The Otoport will not go into standby if a test is being performed. To resume from standby, press any button on the keypad. The Otoport will wake up and return to the previous screen displayed.
Page 180 CHAPTER TWENTY-ONE Power Battery charge 21.4 When the Otoport is switched on, the opening screen shows a battery indicator which displays the remaining level of battery charge. The indicator has 5 segments which convey the total battery charge remaining. The battery segments are shaded according to the following criteria.
Page 181 Otoport OAE+ABR User Manual for Otoport DP+TE model Low battery 21.4.1 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 182 CHAPTER TWENTY-ONE Power Charging the Otoport 21.5 TRAINING REQUIRED Observe the on-screen battery indicators to determine when to charge your Otoport. In general it is advisable to charge the Otoport batteries when the indicator is empty, showing less than 10% charge. However, the batteries should be at least 30% charged if a full day’s testing is planned.
Page 183 Otoport OAE+ABR User Manual for Otoport DP+TE model Notes: If forced it is possible to insert the charger connector into the Otoport the wrong way up. In this position the Otoport will not charge. Disconnect the connector and re-insert with the arrow facing upwards.
Page 184 CHAPTER TWENTY-ONE Power Additional charge indicators 21.5.2 There are additional charge indicators on the side of the Otoport. • Power light - The green light below the plug symbol shows that the device is powered. • Charging light - The orange light below the battery symbol will illuminate when the device is being charged.
Page 185 Otoport OAE+ABR User Manual for Otoport DP+TE model Conditioning the Otoport battery 21.6 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, using a function provided in the Otoport System area and then fully charging the device (see section 15.4...
Page 186 CHAPTER TWENTY-ONE Power Otoport OAE+ABR 21.7 The instrument is powered from the Otoport’s internal rechargeable battery. The Otoport may be charged in situ via the Charger and PC cable socket at the lower end of the ABR Module. Connecting the Otoport OAE+ABR to the charger cable 21.7.1 Switch off the instrument prior to charging.
Page 187 Otoport will not switch on and complete its start up sequence, check that it is charged and try again. If the Otoport still fails to complete its start up sequence then contact your distributor or Otodynamics for support. System details 22.3...
Page 188 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 189 Noise detected through the probe does not indicate a fault. If this message is displayed, turn the unit off, disconnect the probe and then turn it back on. If the message is consistently displayed with the probe disconnected, then contact Otodynamics.
Page 190 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 191 User Manual for Otoport DP+TE model 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 192 Calibration Calibration The Otoport is a precision instrument designed to make accurate measurements of OAE & 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 chapter ) to ensure the instrument is working correctly.
Page 193 Otoport OAE+ABR User Manual for Otoport DP+TE model Mode of operation DPOAE test 26.1 Parameter Description Checkfit stimulus 80µs positive broadband square wave pulse with an intensity of 64dB pe (peak equivalent) in a 1cc cavity. Sample rate 25.6kHz Sample buffer 80ms (gives 2048 points) FFT frequency bin 25Hz...
Page 194 CHAPTER TWENTY-SIX Mode of operation TEOAE test 26.2 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. Sample rate 20kHz Stimulus pattern...
Page 195 Otoport OAE+ABR User Manual for Otoport DP+TE model 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 2.5-12.5 ms or 4-10 ms after start of stimulus.
Page 196 CHAPTER TWENTY-SIX Mode of operation ABR test 26.3 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 197 Otoport OAE+ABR User Manual for Otoport DP+TE model Stimuli description 26.3.1 Click stimuli: 80µS duration square pulse of alternating polarity. Chirp stimuli: 2.5ms duration rapidly swept tone 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 198 CHAPTER TWENTY-SIX Mode of operation Hearing Level determination 26.3.2 The hearing threshold for these stimuli was determined in a group of 20 subjects with normal hearing aged <25. The peak-to–peak levels (dBppSPL) of these stimuli were measured in a Brϋel & Kjær Ear Simulator Type 4157.
Page 199 Otoport OAE+ABR User Manual for Otoport DP+TE model 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 200 CHAPTER TWENTY-SIX Mode of operation Specificity 26.3.4 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. Specificity is therefore the probability of a ‘Valid ABR’...
Page 201 Otoport OAE+ABR User Manual for Otoport DP+TE model • 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 202 90mm x 38mm x 28mm – Weight 120g Interfaces 27.1.2 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) Indicators 27.1.3...
Page 203 Otoport OAE+ABR User Manual for Otoport DP+TE model Clock/Calendar 27.1.5 Internal Real Time Clock/Calendar operates to 2099 Power 27.1.6 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 204 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 205 Otoport OAE+ABR User Manual for Otoport DP+TE model Classifications and standards 27.1.12 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...
Page 206 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 207 Otoport OAE+ABR User Manual for Otoport DP+TE model 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...
Page 208 CHAPTER TWENTY-SEVEN Technical specifications 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 209 Otoport OAE+ABR User Manual for Otoport DP+TE model 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 210 CHAPTER TWENTY-SEVEN Technical specifications 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 211 (‘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 212 CHAPTER TWENTY-SEVEN Technical specifications 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. Immunity test IEC 60601 Compliance...
Page 213 Otoport OAE+ABR User Manual for Otoport DP+TE model 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 214 CHAPTER TWENTY-SEVEN Technical specifications 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 215 Otoport OAE+ABR User Manual for Otoport DP+TE model 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 216 CHAPTER TWENTY-SEVEN Technical specifications 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 217 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 218 CHAPTER TWENTY-SEVEN Technical specifications 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 219 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 27.5.3...
Page 220 CHAPTER TWENTY-SEVEN Technical specifications Symbol explanations 27.6 Class II Type BF Bluetooth ® 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 Noise OK indicator...
Page 221 Otoport OAE+ABR User Manual for Otoport DP+TE model Refer to operating instructions Otodynamics’ factory address Product catalogue number Product date of manufacture Product serial number RF transmitter Training required TRAINING REQUIRED...
Page 222 CHAPTER TWENTY-SEVEN Technical specifications...
Page 223 Otoport OAE+ABR User Manual for Otoport DP+TE model Index Cable clip 169 ABR 52 Calendar 203 ABR cable test 165 Calibration 192 ABR controls 26 Cancelling the test 74, 82 ABR labelling 27 Cavity test 166 ABR module 29, 186, 219 Certification 25, 28 ABRScreen 129 Changing probe coupler tubes 173...
Page 224 CHAPTER TWENTY-EIGHT Index Data summary 91 Good stimulus 23 Data entry keypad 23 Date and time 135 Deleting characters 42 Detailed results 115 Hard reset 42 Disconnecting the probe 44 Hardware fault messages 189 Dismantling the probe 174 Hardware options 203 Display 23, 118 Hardware processing and storage 203 Downloading 146, 149...
Page 225 Otoport OAE+ABR User Manual for Otoport DP+TE model Maximum NLo Sweeps 81 Paper 156 Memory status 136 Pass 161 Menu selection buttons 23 Password 49 Minimum recordable signal level 73 Patient details 101 Mode 122 Patient list 111 Mode select 48, 117 Pausing and cancelling the test 82 Myogenic activity 59 Poor probe fit 75, 83...
Page 226 CHAPTER TWENTY-EIGHT Index Sample buffer 193 TC 91 Sample rate 193 Template correlation 91 Screen modes 62 TEOAE probe tips 171 Screen settings 117 TEOAE settings 122 Service 191 TEOAE test results 83 Setup 140 TE Quick 122 Signal and noise calculation 195 TE stimulus adjustment 76 Skin preparation 55 Test mode defaults 133...
Page 227 Otoport OAE+ABR User Manual for Otoport DP+TE model...
Page 228 CHAPTER TWENTY-EIGHT Index...

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Otoport oae+abr Dp clinical flexi Dp+te Otoport flex Otoport dp+te oae

Otodynamics DP Clinical User Manual

1 Introduction

2 Equipment Identification

3 Getting Started

4 Switching on

5 Test Preparation

6 Test Troubleshooting

7 Test Selection

8 DPOAE Test

9 TEOAE Test

10 ABR Test

11 Saving the Test

12 Link-Test

13 Work List

14 Utilities

15 Configuration

16 Printing and Downloading

17 Quality Tests

18 Probe, Tips and Accessories

19 Probe Care

20 Care of the Otoport

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