Otodynamics Otocheck ABR User Manual
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Otodynamics Otocheck ABR User Manual

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Issue 4

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Summary of Contents for Otodynamics Otocheck ABR

  • Page 1 Otocheck User Manual Otocheck Issue 4...
  • 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

    User Manual Contents Introduction Intended Use General guidance General use precautions Auditory Brainstem Response Equipment identification Supplied in Otocheck ABR kit Optional accessories Controls, indicators and connections Labelling Getting started Connecting probes and electrodes Initial charge Using the keys and keypad...
  • Page 4 CHAPTER ONE Introduction ABR test problems Impedance values are too high and the test will not run High myogenic activity/artefact reject High environment electrical noise No response in ear with known normal hearing ABR test Impedance check Checkfit Ear cup Checkfit ABR test Quick Save option Review...
  • Page 5 Otocheck ABR User Manual Printing and downloading Bluetooth wireless printing and download 11.1 Wired downloading 11.2 When you can print and download 11.3 The printing process 11.4 Printer fault detection 11.5 Printer light summary 11.6 Paper 11.7 Charging the printer 11.8...
  • Page 6 18.2 System details 18.3 Instrument fault message 18.4 Hardware fault messages 18.5 Training Obtaining service Calibration Mode of operation ABR test 22.1 Technical specifications Otocheck ABR 23.1 Electromagnetic Compatibility: Otocheck ABR 23.2 EN60645-3 conformance notes 23.3 Symbol explanations 23.4 Index...

  • Page 7: User Manual

    User Manual Introduction Intended Use This Otodynamics Otocheck ABR device is indicated for use when there is a requirement to screen for hearing disorders by objective and non-invasive means. ABR screening test results are automatically interpreted and a clear ‘Pass’ or ‘Refer’ result is presented to the user who will be a trained screener, audiologist or medical professional.

  • Page 8: General Use Precautions

    CHAPTER ONE Introduction General use precautions TRAINING REQUIRED Do not connect the patient to high frequency (HF) surgical equipment and to an Otocheck in ABR mode simultaneously. Failure to observe this precaution may result in burns at the site of the electrodes and possible damage to the Otocheck.

  • Page 9: User Manual

    Otocheck ABR User Manual If contamination occurs the coupler tubes must be replaced (see 15.2 Changing probe coupler tubes). Visually inspect the coupler tubes before use. A blocked sound delivery tube may prevent the Otocheck from achieving its target stimulation level and so prevent testing.

  • Page 10: Auditory Brainstem Response

    If EEG and myogenic artefacts are below a tolerable (noise reject) level, the Otocheck ABR firmware will detect the ABR and automatically give a simple Pass/Fail response to the user. Other details of the test including the ABR waveforms may also be viewed, and results interpreted, manually...

  • Page 11: Equipment Identification

    Otocheck ABR User Manual Equipment identification Supplied in Otocheck ABR kit OC-ABR Otocheck ABR REF ABR-EC1 Electrode cables - 1m REF ABR-EC2 Electrode cables - 2m REF ABR-SK Starter kit of electrodes, skin preparation gel and pack of cotton wool pads...
  • Page 12 CHAPTER TWO Equipment identification REF PR-UGS UGS probe REF PR-POUCH Drawstring probe pouch Re-order quantity: 10 REF PR-CLIP Probe cable clip REF ABR-CAV Probe cavity and ABR cable tester REF OAE-CAV Probe test cavity...

  • Page 13: User Manual

    Otocheck ABR User Manual REF ABR-INF Infection control sleeve for Otocheck ABR unit only REF ABR-CAS Equipment case for Otocheck ABR kit TPC probe coupler tubes x 5 See chapter 15 for fitting instructions Re-order codes: REF TPC-10 (quantity: 10)
  • Page 14 CHAPTER TWO Equipment identification REF OP-CHG Charger and mains lead REF OP-CAB PC downoad cable REF OTOLINK Otolink software CD Documentation pack Includes instrument and software manuals, quickstart and probe use guides...

  • Page 15: Optional Accessories

    Otocheck ABR User Manual Optional accessories REF OMP-R Otocheck printer Wireless printing REF ABR-CUP Ear cups Optional accessory for ABR screening as an alternative to direct probe use...

  • Page 16: Controls, Indicators And Connections

    CHAPTER TWO Equipment identification Controls, indicators and connections Probe sockets and electrode sockets Impedance check indicator LEDs Stimulus OK (S) and Noise OK (N) indicators Display screen Quick-release clips Menu selection keys Up/down/left/right navigation keys Otoport Lite controls and keypad On/Off power key ‘USB/PSU’...

  • Page 17: Labelling

    Otocheck ABR User Manual Labelling Symbols 2.4.1 The label uses the following symbols: Caution Refer to user manual Class II electrical protection (double insulated) Type BF applied part Manufacturer Serial Number...
  • Page 18 Equipment identification Serial number 2.4.2 The Otocheck 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 19: Getting Started

    Otocheck ABR User Manual 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 3.1.1 The probe plug contains a ‘key’ that must be aligned with the ‘keyway’ in...

  • Page 20: Disconnecting The Probe

    CHAPTER THREE Getting started It is possible to feel when the probe key is aligned as the probe will mate with the socket easily. Probe key Arrow Push the probe into the socket until it hits the end stop. DO NOT force the probe in further.

  • Page 21: User Manual

    Otocheck ABR User Manual Connecting the electrodes 3.1.3 The Otocheck ABR is supplied with an electrode cable loom featuring snap stud connectors for electrode attachment. Alternatively, any wired electrodes that are terminated with 1.5mm ‘Touchproof’ DIN 42-802 connectors may be used.

  • Page 22: Initial Charge

    CHAPTER THREE Getting started Initial charge Before using the equipment for the first time, fully charge the unit. See chapter Power for details. Using the keys and keypad Control keys 3.3.1 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.

  • Page 23: User Manual

    Otocheck ABR User Manual Entering characters 3.3.3 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 24 CHAPTER THREE Getting started Entering dates 3.3.5 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 25: User Manual

    Otocheck ABR User Manual Deleting characters 3.3.7 The bottom right hand key shown above is used as a delete key. If the cursor is at the end of a row of characters, press this key to delete the last character.

  • Page 26: Switching On

    CHAPTER FOUR Switching on Switching On Switch on screen To switch on the Otocheck 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 Otocheck 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 27: Logo Screen

    User Manual 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 28: Login

    CHAPTER FOUR Switching on Login If Login is on (see section ) the login screen will be displayed and the 10.6 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 29: Main Menu

    Otocheck ABR User Manual Main menu You are then presented with the main menu screen. From here you can view the Result of the last test, select the Last patient tested or perform a Test. ABRcustom only available if configured (see chapter 10) Use the left and right arrows to access Records and the Work List. See chapters for further details.

  • Page 30: 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 Power for information). Ensure the Otocheck is charged (see chapter Ensure the Otocheck weekly checks are being regularly conducted (see chapter Quality tests for information).

  • Page 31: Tip Selection And Probe Fitting

    Otocheck ABR User Manual Tip selection and probe fitting Appropriate tip selection and good probe fit are essential to ensure successful recordings. A good probe fit will help to block out external noise and enhance the signal. The Otocheck is supplied with a full range of tips to fit all ear canal sizes.
  • Page 32 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 33: Electrode Fitting

    Otocheck ABR User Manual 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 34 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 35: User Manual

    Otocheck ABR User Manual 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.

  • Page 36: Abr Test Problems

    CHAPTER SIX Test troubleshooting ABR test problems Impedance values are too high and the test will not run 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 37: High Myogenic Activity/Artefact Reject

    Otocheck ABR User Manual High myogenic activity/artefact reject The most common cause of electrical interference is myogenic (muscle) activity from a restless baby. Solutions: 1. Check that all electrode and cable connections are secure. 2. Switch off lights in the test area.

  • Page 38: High Environment Electrical Noise

    CHAPTER SIX Test troubleshooting High environment electrical noise Audible noise in the room as well as interference from other electrical equipment may trigger an artefact reject signal. Solutions: 1. Check that all electrode and cable connections are secure. 2. Switch off any non-essential equipment in the room. 3.

  • Page 39: Abr Test

    Otocheck ABR User Manual 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 10.3.4...

  • Page 40: Impedance Check

    CHAPTER SEVEN ABR test procedure Impedance check The Otocheck 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 Otocheck also checks the noise levels, marked TN and PN on the screen.

  • Page 41: User Manual

    Otocheck ABR User Manual 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 chapter ABR test problems.
  • Page 42 CHAPTER SEVEN ABR test procedure Further advice on ... Otocheck 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 43: User Manual

    Otocheck ABR User Manual 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 44: Checkfit

    CHAPTER SEVEN ABR test procedure Checkfit Before the ABR test starts, the probe fit will be checked. Checkfit display 7.2.1 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 45: User Manual

    Otocheck ABR User Manual 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 46: Ear Cup Checkfit

    CHAPTER SEVEN ABR test procedure Ear cup Checkfit To test with ear cups, the Ear Cup mode in ABR Other Settings must be set to Auto or On. The T7M tip (UGS probes) or the R7M tip (UGD probes) should be used to secure the probe to the ear cup. See section for more details.

  • Page 47: Abr Test

    Otocheck ABR User Manual ABR test During the test the Otocheck 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.
  • Page 48 CHAPTER SEVEN ABR test procedure Data summary 7.4.1 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 49: User Manual

    Otocheck ABR User Manual If ABR noise is too high (>85nV), a valid ABR cannot be detected, so the test will continue to run even if other pass criteria are met. Waveform display 7.4.2 Noisy ABR Good ABR 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.
  • Page 50 CHAPTER SEVEN ABR test procedure Stimulus monitoring 7.4.4 At intervals during the testing the acoustic stimulus and noise levels are checked. If the stimulus level has changed the ‘Check Probe Fit’ message is shown. If the environment has become too noisy to test the ‘Noisy’ message is shown.

  • Page 51: User Manual

    Otocheck ABR User Manual AutoStop If the test data collected meets the set pass criteria then the test will AutoStop and a large checkmark will be displayed. The test result can be saved at this point, or the results can be reviewed prior to saving.
  • Page 52 CHAPTER SEVEN ABR test procedure 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. Probe fit lost or high acoustic noise If the ‘Check Probe Fit’...

  • Page 53: User Manual

    Otocheck ABR User Manual Stopped Too Soon The test has been ended manually before the minimum amount of data required had been collected. Atypical Waveform The template correlation (TC) is low but Fsp is high. A possible ABR has been detected but it did not match the neonate template.

  • Page 54: Quick Save Option

    CHAPTER SEVEN ABR test procedure Quick Save option The options available from the test result screen depend on the Quick Save option (see chapter Configuration) Quick Save On 7.5.1 If Quick Save is On, select Left to save the test to the left ear, or Right to save to the right ear.

  • Page 55: Review

    Otocheck ABR User Manual After the save is confirmed, the option to retest the same patient will be displayed. Select Yes to run another test on the same patient or No to return to the main menu. Quick Save Off 7.5.2...

  • Page 56: Save

    CHAPTER EIGHT Worklist Save The Enter details screen is shown. The patient ID is filled with an automatically generated ID. The Name field displays Auto. The user may either save these details or overwrite them with alternative patient’s details. If an ID is not required, this field may be used as a notes field. A Date of Birth (D.O.B) and Gender may also be added for the patient.

  • Page 57: User Manual

    Otocheck ABR User Manual Select left or right ear 7.7.1 The Select Ear screen represents the patient facing you. By defaulting to a No Ear Choice the Select Ear screen forces the user to choose an ear before the test can be saved. Press the right control key or the right arrow to select the Left Ear or press the left control key or the left arrow key to select the Right Ear.
  • Page 58 CHAPTER EIGHT Worklist The pop up message Last Test Saved to Left/Right Ear. Save Test to Left/Right Ear Again? may appear on Save if the patient’s previous test was saved to the same ear. Select Yes to accept the current ear choice or No to return to the Select Ear screen.

  • Page 59: Worklist

    Otocheck ABR User Manual Worklist The Worklist allows details for multiple patients to be entered into the Otocheck prior to testing. This eliminates the need for data entry while with the patient, allowing for faster, more flexible testing. The Worklist is On by...

  • Page 60: Testing From The Worklist

    CHAPTER EIGHT Worklist When details are complete, select Save to save the details to the Worklist, Test to run a test on this patient, or Back to discard these patient details. Up to 50 patients may be added to the Worklist. Testing from the Worklist Scroll to the required patient.

  • Page 61: Deleting Patients

    Otocheck ABR User Manual Deleting patients Scroll to the required patient. Select Delete to remove. Select Yes to delete the selected patient from the Worklist. Select All to delete all of the patients from the Worklist. Select No to return to the...

  • Page 62: Records

    CHAPTER NINE Records Records The Records section allows the user to see the Results of previous tests and to view the Details of patients previously tested. Records may be erased from the Memory Status screen accessed from the Configuration area (see chapter Records also allows the user to select a previously tested patient for a new test.

  • Page 63: Patient List

    Otocheck ABR User Manual Patient list The Patient list displays the ID/Notes field and Name of each patient. The up and down arrow indicators to the left of the Patient list show that there are other patient records not currently visible on screen. At the top of the...
  • Page 64 CHAPTER NINE Records Details 9.1.1 The Patient Details screen allows the user to see the ID/Notes field, 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 65: User Manual

    Otocheck ABR User Manual Test summary 9.1.2 TRAINING REQUIRED The test summary gives an overview of the test result. The diagrams below illustrate the features of a test summary screen. The number of tests currently saved to the patient is displayed in the top right of the screen.

  • Page 66: Configuration

    CHAPTER TEN Configuration Configuration TRAINING REQUIRED Configuration menu 10.1 The Configuration menu can be accessed by selecting Config on the logo screen after switching on. 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.

  • Page 67: Quality Tests

    Details of how to perform the probe and elecrode cable tests are in chapter Quality tests. Test settings 10.3 The Otocheck 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.
  • Page 68 CHAPTER TEN Configuration ABRscreen and ABRcustom 10.3.1 Use the arrow keys to navigate and choose between the setup options. Select Save to apply the settings changes you have made and return to the Configuration screen. Select Cancel to discard changes and return to the Configuration screen. Stim level Stim Level sets the stimulus level used in the ABR test in dBHL.

  • Page 69: User Manual

    (30-45dBnHL), adult ears up to the volume of a neonate screening ear cup. The Otocheck ABR is capable of recording ABR responses from patients of all ages provided a non-template (Fsp only) pass criteria is selected (PC1 or PC4). However the specificity of the...
  • Page 70 CHAPTER TEN Configuration 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 71: User Manual

    Otocheck ABR User Manual 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 72 CHAPTER TEN Configuration 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 73: User Manual

    Otocheck ABR User Manual 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.

  • Page 74: Date And Time

    CHAPTER TEN Configuration Date and time 10.4 The date and time set on the device can be altered in the Date & Time screen. When the Date field is highlighted press the right arrow key to access the calendar pop-up table. By default, the day will be highlighted first and can be altered using the up and down arrow keys.

  • Page 75: System

    Otocheck ABR User Manual System 10.5 The System screen allows users to view information on Memory Status, Controls, Battery power, System Information or to change the Setup. Memory status 10.5.1 The Otocheck has the capacity to store up to 500 test records. The memory status screen displays the number of records currently stored and the percentage memory still available.
  • Page 76 CHAPTER TEN Configuration If the Memory Status screen has been displayed because the Otocheck memory is full or nearly full, the user will also have the option to Download data to a PC using Otolink. Controls 10.5.2 Volume Use the left and right arrow keys 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 77: User Manual

    Otocheck ABR User Manual Battery 10.5.3 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 78 CHAPTER TEN Configuration Setup 10.5.4 Quick Save If Quick Save is On then test results can be saved from the test result screen with a single key push (see chapter ABR Test for details). If Quick Save is Off then options to enter patient details and review the test result are available before test is saved.

  • Page 79: User Manual

    Otocheck ABR User Manual 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 80 CHAPTER TEN Configuration Print type Print type controls the length and detail contained in the Otocheck printout. The Summary format prints only core patient and test details. The Detailed format prints a fuller set of patient and test quality details. On connect On connect printing allows printing to be initiated as soon as a wired printer is connected.

  • Page 81: Users

    Otocheck ABR User Manual System info 10.5.5 The System Info screen provides information on the Otocheck. System Details System Details displays information for Otodynamics engineers. (See section for further details). 18.3 About The About screen provides information relating to the Otocheck’s identification and mode of operation.
  • Page 82 CHAPTER TEN 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 10.6.1 To add a New User, complete the field entries shown on the New User screen.

  • Page 83: User Manual

    Otocheck ABR User Manual A new user is given a choice of two levels of access rights. If Yes is selected in the administrator field, then the user will have full access to all the Config areas of the device. Select No to restrict the user’s rights to only the Probe test area in Config, disabling access to higher level functions.

  • Page 84: Printing And Downloading

    Wireless printing and downloading are only available on Bluetooth enabled Otocheck ABR and Otoport instruments. If a Bluetooth module is fitted, a Bluetooth symbol (shown above) is included on the product label. Downloading can also be performed with a wired connection, using the cables supplied.

  • Page 85: Wired Downloading

    User Manual Bluetooth download requires that Otolink software is installed and that your Otocheck ABR 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...

  • Page 86: When You Can Print And Download

    CHAPTER ELEVEN Printing When you can print and download 11.3 The Otocheck provides flexible options, as described on the following pages. Print and PC-Load settings are located under Configuration in System, Setup. Bluetooth must be set to Print or PC-Load as required (see section Setup).
  • Page 87 Otocheck ABR User Manual Printing at the end of a test 11.3.1 When the ABR test is finished and the result has been saved, select Print for a printout of the patient details and test results (see section 10.5 Automatic print/download on save 11.3.2...
  • Page 88 CHAPTER ELEVEN Printing 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 Records menu to download all new records for all patients and tests that haven’t previously been downloaded.

  • Page 89: The Printing Process

    Otocheck ABR User Manual The printing process 11.4 The wireless printing method has a range of up to 10m in direct line of sight. It is recommended that the printing distance is reduced to 5m to help ensure robust communication. Remain within this range for the duration of the printout.
  • Page 90 CHAPTER ELEVEN Printing 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 printer (Alter.) or retry. To retry the print, ensure the printer is switched on and is within range (5m). Then select Retry.

  • Page 91: Printer Fault Detection

    Otocheck ABR User Manual Printer fault detection 11.5 The printer can detect if the paper roll has run out, or if the lid is open. Under these circumstances the Otocheck will report the printer is out of paper and the following message will be displayed.

  • Page 92: Paper

    CHAPTER ELEVEN Printing Paper 11.7 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 93: Charging The Printer

    Otocheck ABR User Manual Charging the printer 11.8 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 94: Changing The Battery

    4 AAA batteries, is provided with the printer. Alternatively a new battery pack can be obtained from your dealer or Otodynamics. To change the battery pack: Remove the screw (1) from the battery compartment cover. Push down, and slide back the battery compartment cover (2).

  • Page 95: Scanning

    Otocheck ABR User Manual Scanning Scanning facility 12.1 As well as the standard data entry method using the keypad, the Otocheck 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 96 CHAPTER TWELVE Scanning The Otocheck 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 12.2.2 This method scans radio frequency identification (RFID) chips, which can hold enough alphanumeric data for a complete patient data record on the Otocheck.

  • Page 97: When To Use The Scanners

    Otocheck ABR User Manual When to use the scanners 12.3 Entering patient details 12.3.1 If a scan option is fitted, patient details may be entered using the Scan facility. To access the Scan function, first press any key (except the menu selection keys).
  • Page 98 CHAPTER TWELVE Scanning At login 12.3.3 In order for a user to login using the scanning method it is necessary to set- up their login account in the Users area (see chapter Configuration for more details). On the New user screen, select Scan. The RFID method can set all user parameters.

  • Page 99: Quality Tests

    Otocheck ABR User Manual Quality tests Damage or malfunction of the Otocheck, 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.
  • Page 100 CHAPTER THIRTEEN Quality checks On selection of Probe Test the message Place Probe into Otodynamics Test Cavity. Press OK to begin test. will be displayed. 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 101 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 102 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 103 Otocheck ABR User Manual 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 104: Abr Cable Test

    CHAPTER THIRTEEN Quality checks ABR cable test 13.2 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 105: Abr Cavity Test

    This will identify which component is responsible for the problem. Contact your dealer or Otodynamics for further advice. 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.

  • Page 106: Probe, Tips And Accessories

    CHAPTER FOURTEEN Probe, tips and accessories Probe, tips and accessories Probe and service accessories 14.1 Your kit will include a probe with appropriate sample coupler tubes and Equipment identification for details. spare probe body/lid. See chapter Probe cable clip 14.2 The probe cable clip is provided to aid the practical aspects of positioning and securing the probe cable during testing.
  • Page 107 Otocheck ABR User Manual 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.

  • Page 108: Probe Tips

    CHAPTER FOURTEEN Probe, tips and accessories Probe tips 14.3 Samples of the tips are provided with your instrument. Further supplies may be obtained from your distributor or from Otodynamics. REF T-T3E Fits ~3mm ear canal Small and premature newborns T5.5B REF T-T5C REF T-T5.5B...
  • Page 109 14.3.2 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 110: Probe Care

    REQUIRED Cleaning 15.1 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. Cable - The cable may be cleaned with antiseptic fluid or wipes.
  • Page 111 Otocheck ABR User Manual Disassembling the probe 15.2.1 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.

  • Page 112: Probes Safety Note

    Probe care Probes safety note 15.3 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 113: Care Of The Otocheck

    Other than the probe ear piece and cable, the Otocheck 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 114 CHAPTER SIXTEEN Care of the Otocheck ABR 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 115: Power

    Otocheck ABR User Manual Power Important Note: Only charge your Otocheck with the charger supplied by Otodynamics. Battery life 17.1 The instrument is powered from the Otocheck’s internal rechargeable battery. The battery will provide enough power for over 100 ABR tests from a single charge with a battery life of up to 8 hours.

  • Page 116: Standby

    CHAPTER SEVENTEEN Power Standby 17.3 To save power, the Otocheck will go into standby mode after 3 minutes of inactivity. The standby screen will be displayed. The Otocheck will not go into standby if a test is being performed. To resume from standby, press any key on the keypad. The Otocheck will wake up and return to the previous screen displayed.

  • Page 117: Battery Charge

    Otocheck ABR User Manual Battery charge 17.4 When the Otocheck 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 118 CHAPTER SEVENTEEN Power Low battery 17.4.1 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 119: Charging The Otocheck

    Note: Do not charge more than one Otocheck on the same PC at any one time. Connecting the Otocheck ABR to the charger cable 17.5.1 Switch off the instrument prior to charging. Connect the mains lead to the charger, plug the mains lead into a power socket and switch on the power.
  • Page 120 When the device is fully charged a large tick will appear on the screen. Charge indicator lights 17.5.2 There are additional charge indicators on the side of the Otocheck ABR. • Power light - The green light above the plug symbol shows that the device is powered.
  • Page 121 Otocheck ABR User Manual It is possible to leave the charger connected to the Otocheck for extended periods, even if the device is fully charged. This may be convenient if you wish to leave the device charging overnight. Disconnecting the Otocheck 17.5.3...

  • Page 122: Conditioning The Otocheck Battery

    CHAPTER SEVENTEEN Power Conditioning the Otocheck battery 17.6 In order to maintain the Otocheck battery and keep it at optimal performance you should condition the battery once per year, or if the unit’s battery appears to run down more quickly than expected. This process involves completely discharging the battery, using a function provided in the Otocheck System area and then fully charging the device (see chapter Configuration).

  • Page 123: Additional Battery Care

    Otocheck ABR User Manual Additional battery care 17.7 If the Otocheck is not in regular use, in order to maintain the battery, fully charge the device every two months.

  • Page 124: Equipment Troubleshooting

    System details menu and check for any error number reported at the top of the screen. If zeros are reported at the top of the screen, no errors have been detected on the device. For support regarding a fault, report error numbers to your dealer or Otodynamics.

  • Page 125: Instrument Fault Message

    Otocheck ABR User Manual Select Reset to reset the Otocheck to factory default settings. Changes from the default setting and any users or worklist patients added to the device will be lost. No test data will be removed. Select Format to reformat the Otocheck database. Any records held on the device will be irrecoverably lost.

  • Page 126: Hardware Fault Messages

    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 127: 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 ABRs and use of the equipment may also be provided by previously trained staff and qualified audiologists.

  • Page 128: Obtaining Service

    128 CHAPTER TWENTY Obtaining service Obtaining service Otodynamics or its authorised distributor will replace or service, free of charge, this Otocheck during the period of warranty, where the fault is not associated with misuse. Servicing after that period will be provided at reasonable cost.

  • Page 129: Calibration

    The About screen displays the calibration due date for your Otocheck, if a date has been set (see section ). A prompt when switching on will 10.5.5 warn that calibration is due from 30 days before the due date. Contact your dealer or Otodynamics to arrange a calibration check.

  • Page 130: Mode Of Operation

    CHAPTER TWENTY-TWO Mode of operation Mode of operation ABR test 22.1 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...
  • Page 131 Otocheck ABR User Manual Stimuli description 22.1.1 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 132 CHAPTER TWENTY-TWO Mode of operation Hearing Level determination 22.1.2 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 133 These electrode signals were then replayed at their original level into the Otocheck ABR and a total of 3257 ABR further tests were run to ensure all statistical combinations of noise and instrument timings were represented.
  • Page 134 The mean amplitudes of ABR from 270 infant was determined from healthy normally hearing baby’s ABR recorded by the Otocheck ABR using our short chirp stimulus at a level of 35dBnHL and a rate of 52 per second. The normal distribution (spread) of ABR amplitudes...
  • Page 135 Otocheck ABR User Manual • 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...

  • Page 136: Technical Specifications

    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 Bluetooth wireless print (option)
  • Page 137 Otocheck ABR User Manual Keypad 23.1.3 19 key alphanumeric with cursor control and soft keys Clock/Calendar 23.1.5 Internal Real Time Clock/Calendar operates to 2099 Power 23.1.6 Li-Polymer Battery Intelligent multi-level power control for charging/testing/idle/sleep/shutdown: After 1.5 minutes unit will enter sleep mode...
  • Page 138 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 139 Otocheck ABR User Manual Classifications and standards 23.1.12 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:...
  • Page 140 Otocheck ABR. Guidance and manufacturer’s declaration – electromagnetic emissions The Otocheck ABR is intended for use in the electromagnetic environment specified below. The user of the Otocheck ABR should ensure that it is used in such an environment. Emissions test...
  • Page 141 User Manual Guidance and manufacturer’s declaration – electromagnetic immunity The Otocheck ABR is intended for use in the electromagnetic environment specified below. The user of the Otocheck ABR should ensure that it is used in such an environment. Immunity test...
  • Page 142 CHAPTER TWENTY-THREE Technical specifications The following functions of the Otocheck ABR are deemed ‘essential performance’ and were tested for immunity in compliance with IEC60601-1-2: (a) The collection of Auditory Brainstem Responses (ABRs) (b) The retention of user settings and test results...
  • Page 143 User Manual Guidance and manufacturer’s declaration – electromagnetic immunity The Otocheck ABR is intended for use in the electromagnetic environment specified below. The customer or the user of the Otocheck ABR should ensure that it is used in such an environment.
  • Page 144 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Otocheck ABR is used exceeds the applicable RF compliance level above, the Otocheck ABR should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Otocheck ABR.
  • Page 145 The frequency bands for reception and transmission of RF energy for these functions are as follows: (a) Bluetooth – 2.4GHz to 2.4835GHz (b) RFID – 13.56MHz The Bluetooth and RFID functions of the Otocheck ABR may be interfered with by other equipment, even if that equipment complies with CISPR emission requirements.

  • Page 146: 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 147 Otocheck ABR User Manual Suppose, for example, that a stimulus level of 90dB is reported by the Otocheck 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 148: Symbol Explanations

    CHAPTER TWENTY-THREE Technical specifications Symbol explanations 23.4 Training required TRAINING REQUIRED Class II Type BF 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 149 Otocheck ABR User Manual Refer to operating instructions Otodynamics’ factory address Product catalogue number Product date of manufacture Product serial number Bluetooth ® enabled RF transmitter...

  • Page 150: Index

    CHAPTER TWENTY-FOUR Index Index ABR cable test 104 Calendar 137 ABR labelling 17 Cavity test 105 ABR module 115 Certification 18 ABRScreen 67 Changing probe coupler tubes 110 ABR test problems 36 Charging the Otoport 119 ABR test procedure 39 Charging the printer 93 Accuracy 138 Chirp stimulus 72...
  • Page 151 Otocheck ABR User Manual Ear canal size 44 Impedance check 40 Ear cup Checkfit 46 Impedance check indicator LEDs 16 Ear cups 15, 32, 46, 69, 71 Impedance monitoring 49 Edit User 83 Initial charge 115 Electrode cable loom 11...
  • Page 152 CHAPTER TWENTY-FOUR Index Paper 92 Save 56 Pass 101 Scanner 17 Password 28 Scanning 95 Patient list 63 Select ear 57 Power 137 Service 128 Precautions 8 Skin preparation 33 Printer battery 94 Standby 117 Printer fault detection 91 Stimulus adjustment 45 Printer light summary 91 Stimulus and Noise OK indicators 45 Printing 84...

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