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CHAPTER TWENTY-THREE

Mode of operation

180

Mode of operation

23.3.2

Hearing Level determination

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. For short duration stimuli the dBppSPL values are always

much higher than their dBHL value. For the Click dBppSPL in the ear

simulator exceeds Otoport dBHL value by 33.6dB. For the Chirp dBppSPL

in the ear simulator exceeds Otoport dBHL value by 29.5dB.

23.3.3

Sensitivity

The sensitivity of a hearing screener relates to the ability of the device

to detect ears with hearing loss (the true positive rate). Sensitivity is

measured as the probability of a ‘No Valid ABR’ result being correctly

reported by the device when no ABR is actually present. Departure from

the desired 100% sensitivity figure indicates false passes caused by the

device misinterpreting electrical noise (biological and/or environmental) as

an ABR. The sensitivity of a device must therefore be measured with the

device operating in its screening test mode and exposed to all the differing

levels of EEG noise and power line interference in which the device can be

used, but without any ABR actually being present.

It is important to note that the measured sensitivity of an instrument relates

to the outcome of tests where there is no ABR present. When there is a

hearing loss we can assume that no ABR is present only if the stimulus

level is below the elevated threshold. The demonstrated instrument

sensitivity therefore only applies to the detection of hearing losses greater

than the hearing level of the applied stimulus. It is the applied stimulus

level that determines the range of hearing losses that will be detectable

and to which the sensitivity figure applies. For example if only a small

hearing loss is present such that the hearing threshold is still lower than the

hearing level of the applied stimulus, then a true ABR will be present. The

instrument may correctly detect that response and not detect the hearing

loss.

It is therefore strongly recommended that the stimulus level is set to the

lowest value compatible with the aims and targets of the hearing screening

program. For the reliable detection of mild hearing impairment many

professionals bodies recommend stimulus levels 35dBnHL. Some major

infant screening programs use 40dBHL. Screening with stimulus levels

above 40dBnHL will miss some mild hearing losses.

Содержание Otoport Lite

Страница 1: ...Otoport OAE ABR Otoport Lite model Issue 4 Otoport OAE ABR User Manual for Otoport Lite model...

Страница 2: ...26 1 16 onwards Doc Ref MANABR2 7 4 Copyright Notice No part of this publication may be copied by any means translated or distributed to third parties without the express written permission of Otodyn...

Страница 3: ...3 Supplied in both kits 19 2 4 Optional accessories 22 2 5 Otoport controls indicators and connections 24 2 6 Scanner 25 2 7 OAE labelling 26 2 8 Otoport OAE ABR controls indicators and connections 2...

Страница 4: ...CHAPTER ONE Introduction 4 Introduction...

Страница 5: ...onment checks for ABR 48 5 3 Tip selection and probe fitting 49 5 4 Electrode fitting 51 6 Test troubleshooting 54 6 1 OAE test problems 54 6 2 ABR test problems 55 7 OAE test procedure 57 7 1 Checkfi...

Страница 6: ...CHAPTER ONE Introduction 6 Introduction...

Страница 7: ...103 11 3 Test settings 103 11 4 Date and time 115 11 5 System 116 11 6 Users 122 12 Printing and downloading 125 12 1 Bluetooth wireless printing and download 125 12 2 Wired downloading 126 12 3 When...

Страница 8: ...15 2 Probe cable clip 150 15 3 Probe tips 152 16 Probe care 155 16 1 Cleaning 155 16 2 Changing probe coupler tubes 155 16 3 Probes safety note 157 17 Care of the Otoport 158 17 1 Use of the Otoport a...

Страница 9: ...fault messages 171 20 Training 172 21 Obtaining service 173 22 Calibration 174 23 Mode of operation 175 23 1 TEOAE model 175 23 2 DPOAE model 177 23 3 ABR test 178 24 Technical specifications 184 24...

Страница 10: ...ined screener audiologist or medical professional Use of the device is indicated when the patient is unable to give reliable voluntary responses to sound especially with infants Use of the device faci...

Страница 11: ...m results and short test times the room should be quiet and the patient should be very quiet and still during the test The device will clearly indicate levels of acoustic noise and electrical interfer...

Страница 12: ...d on the same ear The Otoport has built in signal analysis proven to distinguish true OAEs and ABRs from artefactal signals Checks should be performed weekly and before each test session to confirm th...

Страница 13: ...rophone tube will prevent the Otoport from sensing the stimulus level in the ear and from detecting the OAE As a result the Otoport may apply a louder than normal sound to the ear All surfaces of the...

Страница 14: ...the tones in the cochlea at a third frequency 2f1 f2 Different pairs of f1 an f2 frequencies are used in turn to acquire emissions from different areas along the length of the cochlea The two measure...

Страница 15: ...or observation is necessary OAE testing is frequently used as the initial screen within the at risk population Passing the OAE test indicates that normal middle ear and cochlear function is present Th...

Страница 16: ...which are commonly known as auditory evoked potentials A response which occurs within 20ms of the onset of the stimulus is referred to as an Auditory Brainstem Responses ABR As the amplitude of the AB...

Страница 17: ...ment identification 2 1 Supplied only in Otoport OAE ABR kit Otoport Lite OAE ABR REF ABR EC1 Electrode cables 1m REF ABR EC2 Electrode cables 2m REF ABR SK Starter kit of electrodes skin preparation...

Страница 18: ...ection control sleeve for Otoport OAE ABR unit only Shown fitted REF ABR CAS Equipment case for Otoport OAE ABR kit 2 2 Supplied only in Otoport Lite kit REF LTC ST or LTC SD Otoport Lite REF OP CAS E...

Страница 19: ...uipment identification 19 REF PR CLIP Probe cable clip REF PR POUCH Drawstring probe pouch REF PR UGS UGS TEOAE probe Supplied with TEOAE model REF PR UGD UGD DPOAE probe Supplied with DPOAE model 2 3...

Страница 20: ...10 or 100 REF DPC DPC probe coupler tubes x 5 Supplied with DPOAE probe Re order quantity 10 or 100 REF BGS BGS probe body and lid x 1 Supplied with TEOAE probe Re order quantity 10 REF BGD BGD probe...

Страница 21: ...tification 21 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 gui...

Страница 22: ...downloading to PC REF OMP R Otoport printer Wired and wireless models available for Otoport Lite Wireless model available for Otoport OAE ABR REF OPP CAS Large equipment case For use with Otoport Lit...

Страница 23: ...Printer accessories and consumables REF OMP PAP R Otoport printer paper rolls Quantity 8 REF OMP CAB R Otoport printer cable For use with Otoport OAE device not for use with ABR REF OMP CHG R Otoport...

Страница 24: ...5 Otoport 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 Charging stat...

Страница 25: ...Otoport OAE ABR User Manual for Otoport Lite model Equipment identification 25 2 6 Scanner Barcode RFID scanner not included as standard Grip strip...

Страница 26: ...Equipment identification 2 7 OAE labelling 2 7 1 Symbols The label uses one or more of the following symbols DC Caution Refer to user manual Class II electrical protection double insulated Type BF app...

Страница 27: ...model code LTC or LDC year and month of manufacture yymm and unique manufacture ID xxxx The complete serial number is therefore LXX yymmxxxx 0120 2 7 2 Certification or regulatory marks The label feat...

Страница 28: ...n 2 8 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 connec...

Страница 29: ...del Equipment identification 29 2 9 ABR labelling 2 9 1 Symbols The label uses the following symbols DC Bluetooth enabled Caution Refer to user manual Class II electrical protection double insulated T...

Страница 30: ...eference Otoport Lite OAE ABR 11 Production date 31st January 2015 21 Serial numbers 1234 Otoport 1234 ABR if ABR module is supplied 240 Additional product ID BRT used to identify any hardware modules...

Страница 31: ...equipment as follows 3 1 Assembling the ABR Module with an Otoport The ABR Module is designed to be fitted as a sleeve to an Otoport unit as described in the following instructions Do NOT force the Ot...

Страница 32: ...1 4 Carefully insert the Otoport into the sleeve and slide it down until the connector at the bottom of the sleeve is inserted into the port at the bottom of the Otoport 3 1 5 Tilt the upper section...

Страница 33: ...arted 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 3 1 6 Lower the sleeve until the connector at the top of t...

Страница 34: ...ect it from the port at the bottom of the sleeve and remove it from the Module Do NOT tilt the Otoport forward while lifting it up 3 3 Otoport OAE ABR with non removable module If you have purchased a...

Страница 35: ...del 35 Getting started 3 4 Connecting probes and electrodes The connections panel for probes and electrodes is found at the top end of the module 3 4 1 Connecting the probe Follow instructions for con...

Страница 36: ...d electrodes that are terminated with 1 5mm Touchproof DIN 42 802 connectors may be used Carefully align the electrode connector plug with the appropriate electrode socket observe colour coding and th...

Страница 37: ...e 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 le...

Страница 38: ...ted first then lower case then numbers e g ABCabc2 For subsequent characters lower case is shown first e g abcABC2 More characters can be stored than can be displayed on the screen Arrows are displaye...

Страница 39: ...t to accept the date displayed or Cancel to ignore the changes If the date has not been edited it will remain as dd Mmm yyyy by default For Date of Birth entry D O B the Otoport will not permit entry...

Страница 40: ...7 seconds following any key press and remains on during testing The backlight can be configured see chapter 8 Configuration 3 6 9 Stimulus and Noise OK indicators blue LEDs The two blue LEDs above th...

Страница 41: ...be to the Otoport 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 Socket keyway Prob...

Страница 42: ...nticlockwise direction until the thread is disengaged Then gently pull the probe out from the probe socket Push the probe into the socket until it hits the end stop DO NOT force the probe in further S...

Страница 43: ...model 43 Getting started Remove probe Important Note Main probe body Do NOT attempt to screw or unscrew the probe by holding the main probe body smooth chrome section This will result in damage to the...

Страница 44: ...the keypad The display screen will show Switch Unit On Select Yes to confirm Otoport switch on or No to turn the unit off again If Yes or No are not selected within two seconds of pressing the on off...

Страница 45: ...raphic will appear to the right of the logo to provide an indication of the Battery Power remaining Please refer to chapter 18 Power for battery information A prompt will be shown if the Otoport is du...

Страница 46: ...is selected use the data entry keypad to enter a corresponding Password if required for that user To improve security during Login a symbol will replace each character as it is entered in the Password...

Страница 47: ...Result of the last test select the Last patient tested or perform a Test The heading on the screen indicates whether the Otoport is a TEOAE or DPOAE model TEOAE model DPOAE Model Use the left and rig...

Страница 48: ...scharge from the ear to be tested Choose a quiet room without background noises Ensure the patient is comfortable and settled Ensure you can clearly see the ear to be tested 5 2 Environment checks for...

Страница 49: ...hat it is clear and free from debris If debris subsequently enters the probe sound tubes do not attempt to clean them the coupler tubes should be changed The correct size tip will look slightly larger...

Страница 50: ...eft ear or 5 o clock for right ear Push the probe firmly into the ear canal at this angle Hold the probe for several seconds Then release the probe No discomfort should be felt by the patient The weig...

Страница 51: ...3 to 4 moderately firm strokes in order to obtain a satisfactory connection to the skin Excessive caution with skin preparation can disturb the baby more than firmer strokes If using a wet prep use a...

Страница 52: ...ons avoid hair when possible When using wet gel electrodes the sticky area around the central gel should be pressed to the skin not the central area itself Shoulder common black and nape of neck negat...

Страница 53: ...The Otoport is optimised for the electrode placements described above Alternative placements are possible including Recommended Alternative 1 Alternative 2 Positive Red High forehead High forehead Hi...

Страница 54: ...ng session when the ear has had time to clear usually brings success Babies are best tested when they are sleeping or sleepy and successful OAE recordings are most often made one hour after a feed The...

Страница 55: ...Neuroline 720 can dry out especially if the foil pouch they are kept in has been opened for some time This can result in very high impedances Check the expiry date on the electrode pouch and then ope...

Страница 56: ...Solutions 1 Check that all electrode and cable connections are secure 2 Switch off any non essential equipment in the room 3 Do not use mobile cellular phones when operating the equipment 4 Separate...

Страница 57: ...procedure A Test may be started by selecting Test or Last from the main menu screen from the Worklist or by selecting Test from the Patient details screen in the Records area You will not be able to...

Страница 58: ...increasing size indicating increasing ear canal volumes The size of ear canal detected in Checkfit is indicated by an arrow During Checkfit the Otoport repeatedly plays a click at a fixed level and re...

Страница 59: ...which is represented by the horizontal line across the Noise Level Indicator In poor testing conditions when the noise level is above the Noise Reject Level the bar will be red The letter below the in...

Страница 60: ...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...

Страница 61: ...ion 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...

Страница 62: ...strength of the OAE detected compared with the level of noise recorded the SNR A fuller circle indicates that the SNR and signal level are closer to the pass criteria Circles The Circles display shows...

Страница 63: ...ise reject threshold level This can be altered using the up and down arrow keys The noise level indicator allows continuous monitoring of the noise level during a test Test condition information When...

Страница 64: ...layed Maximum number of NLo sweeps If a test has not met the set pass criteria it will stop when the Maximum NLo Sweeps NLo sweeps are recordings made with a noise level below the rejection threshold...

Страница 65: ...t 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...

Страница 66: ...will depend on your application see 11 3 Test settings Note The following results will only occur if a TEOAE Pass is not obtained No Valid OAE The data collected has not met the set pass criteria and...

Страница 67: ...Configuration The default pass criteria is an SNR of 6dB and a minimum signal of 5dBSPL in at least three frequency bands It is the responsibility of the user to ensure that the pass criteria set mee...

Страница 68: ...d if the response from the probe indicates a large ear canal 7 3 2 Test screen The Otoport looks at the ratio of the OAE signal to the noise this is known as the Signal to Noise Ratio or SNR The Otopo...

Страница 69: ...s continuous monitoring of the noise level during a test Test condition information When conditions are good for data collection DP TEST will be shown at the top of the screen and progress indicators...

Страница 70: ...cancelling the test 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 Se...

Страница 71: ...eening or clinical measurement see 11 3 Test settings Note The following results will only occur if a DPOAE Pass is not obtained No Valid OAE The data collected has not met the set pass criteria and t...

Страница 72: ...o the right ear The test will be saved to the current patient or will be given an automatic ID and name This name and ID may be edited by selecting Last from the main menu screen see section 7 8 If Au...

Страница 73: ...to run another test on the same patient or No to return to the main menu 7 4 2 Quick Save Off If Quick Save is Off select Save to skip to the Patient Details screen ready to Save Select Review to vie...

Страница 74: ...mark is displayed to indicate a pass If the display is set to Circles small circles appear with a checkmark in each band that met pass criteria Note If the SNR criteria are met but not the minimum sig...

Страница 75: ...Otoport It is not possible to store different facilities for different patients If you wish to change the Facility download and erase all test records from the Otoport first It is also not possible t...

Страница 76: ...ar 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 sel...

Страница 77: ...Ear screen If Auto print is selected the print routine will be activated at this stage 7 7 Final review After saving the user is given the opportunity for a final test review There are options to Prin...

Страница 78: ...ord by selecting Last from the main menu Patient details can be amended and tests printed using this function From the Main Menu select Last The Patient Details screen is displayed Select Test to star...

Страница 79: ...ect 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...

Страница 80: ...VEN OAE test procedure 80 OAE test procedure 7 9 Result Select Result to review the tests results for the current patient Select displays the detailed result for this test Select Print to print this t...

Страница 81: ...connection cable and may differ if other cables are in use Connect the electrode leads and the OAE probe to the ABR unit and prepare your patient Connect the red ve cable to the high forehead the whit...

Страница 82: ...test conditions are good The ABR test will start automatically if the electrode impedances are good and the electrical noise EEG is low for a few moments If test conditions are moderately good If test...

Страница 83: ...rt and it will not be possible to start a test manually A message on the screen will show the problem It will tell you if EEG Noise Powerline Noise or Impedance are preventing the test from starting T...

Страница 84: ...ore than 16 k Poor The green LED lights on the top of the ABR unit will be lit if the connection of the electrode closest to that light is optimum good or moderate Autostart requires that all impedanc...

Страница 85: ...and other devices This level is high if there is a lot of interference from electrical noise and or one or more of the electrodes is poorly connected has high impedance If impedance levels are accepta...

Страница 86: ...7 1 for details Checkfit with ear cups is described below 8 3 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...

Страница 87: ...device will go straight to ear cup Checkfit without checking for ear cup use Ear Cup mode set to Off The device will go straight to normal Checkfit without checking for ear cup use 8 4 ABR test Durin...

Страница 88: ...indication of the amplitude of the current electrical noise level The lower this value is the faster the test will be The data measured during this time will be ignored If there is high noise for a c...

Страница 89: ...d ABR result as continuing the test would not find an ABR present 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 8 4...

Страница 90: ...s are within range again The Otoport will beep to warn the user of test conditions if either Check Probe Fit or Noisy conditions persist If the Check probe fit message is shown it is most likely becau...

Страница 91: ...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 AutoStop If the test data coll...

Страница 92: ...p the test 8 4 7 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 show...

Страница 93: ...eversed Only obtained with pass criteria PC2 and PC3 High Mains Noise Interference from electrical equipment prevented the test from passing The Fsp pass threshold was elevated due to this interferenc...

Страница 94: ...default but can be switched Off in the Config area see chapter 11 Access the Worklist by using the left or right navigation keys from the main menu 9 1 Adding Patients If the worklist already contain...

Страница 95: ...these patient details Up to 50 patients may be added to the Worklist 9 2 Testing from the Worklist Scroll to the required patient Select Test to begin testing this patient When a test has been saved...

Страница 96: ...ents 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 t...

Страница 97: ...revious 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 11 Records also allows the user...

Страница 98: ...e current patient is twelfth in a list of 34 patients Use the up and down arrow keys to scroll through the list one patient record at a time A selected patient will be shown as highlighted in the list...

Страница 99: ...nt Selecting Test from this screen starts a new test the result of which will be saved with the records of the selected patient Selecting the up and down arrow keys on the patient details screen displ...

Страница 100: ...he screen show that there are other saved test records for this patient The left and right arrow indicators display the Patient Details for this patient Select Print to print an individual test summar...

Страница 101: ...Total noise level dBSPL Date of Test Time of Test User ID Total OAE signal level dBSPL Test type Stimulus level Pass criteria TEOAE test summary screen Patient s Name No of Test saved to the patient r...

Страница 102: ...lity 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 Time to set the current date and time Select Syst...

Страница 103: ...is divided into General settings which affect all tests and settings that affect only TEOAE DPOAE or ABR tests depending on the functionality of your Otoport 11 3 1 General Use the arrow keys to navig...

Страница 104: ...een Ear canal cavities greater than 0 5cc will trigger the warning With Neonate setting Off default no warning message is displayed if a large ear volume is detected NReject The threshold above which...

Страница 105: ...solute limit for testing is reached Start With Start 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...

Страница 106: ...z Set Not Set if you are unsure of the mains frequency in your region Setting ABR mains from the main menu If ABR mains is Not Set then you will be prompted to set it when an ABR test is selected from...

Страница 107: ...evel criteria The default setting is One circle If Circles is selected the information on OAE levels in half octave frequency bands centred at 1 1 5 2 3 and 4 kHz is displayed during testing An empty...

Страница 108: ...z narrow mode only The attenuation at these frequencies is 3dB Attenuation increases by 80dB decade below and 40dB decade above these frequencies Mode Mode sets the pass criteria for screening The Wid...

Страница 109: ...timulus level for the TEOAE test or to switch the mode Off If it is set to Off this test mode will not be available for testing 11 3 3 DPOAE Display The display for the Otoport DP is Circles and canno...

Страница 110: ...cy in terms of the dBSPL of the OAE is required at each frequency A good Signal to Noise Ratio SNR in this mode indicates that a high accuracy of measurement has been reached The Rapid mode is appropr...

Страница 111: ...the selected mode ABRscreen or ABRcustom is not available for testing and it will not appear in the main menu carousel The ABRscreen mode is intended for newborn hearing screening The stim level can...

Страница 112: ...d for the setting of precise custom stimulus levels e g for compatibility with prior screening practice Low stimulus levels down to 5dBnHL can be used for the audiological confirmation subjective test...

Страница 113: ...pass criteria are met If Stop is turned OFF the test will run for longer but the ABR levels will be more accurately measured If Stop is ON when screening the test will be as short as possible Stop is...

Страница 114: ...TC exceeds the minimum TC level Or Fsp level exceeds the minimum Fsp and TC exceeds the strict TC level PC4 requires Fsp level exceeds the dynamic Fsp with no template requirement Or Fsp level exceeds...

Страница 115: ...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 Continue to use the left a...

Страница 116: ...cting Erase deletes all test records from the Otoport after requesting confirmation from the user A screen confirming the Erase is then displayed and the user is returned to the main menu If there is...

Страница 117: ...ck to ignore changes and return to the Controls Menu Brightness The screen Brightness can be altered by pressing the left right arrow keys Select Save to accept the adjusted Brightness level Select Ca...

Страница 118: ...y graphic on the right of the screen conveys the total remaining battery power The battery segments are shaded according to the following criteria Segments Displayed Battery Power 7 95 100 6 75 94 5 5...

Страница 119: ...ooth is set to PC Load then the Otoport can use Bluetooth communication to send test results to a PC Details of how to set up wireless download to PC are included in your Otolink manual If Bluetooth i...

Страница 120: ...Cancel to discard any change Note To avoid printout duplication it is not possible to set Auto Send to On and End Data to Patient Print If Print is set to Automatic then the test result is automatica...

Страница 121: ...sts for the last Patient or All unprinted tests Printing will only start if the Otoport is on and displaying one of the main module screens see section 3 4 If Cancel is selected during the print three...

Страница 122: ...s identification and mode of operation The firmware revision number and issue date is stated together with the unit s unique hardware ID The next scheduled Calibration Due date is also shown A dash is...

Страница 123: ...capitalised only optional Admin Select Yes to give the new N A user administrator rights Select No to restrict the user N A to screener rights The User ID is added to a saved test record to identify...

Страница 124: ...etails of a highlighted user Select Save to save changes to the user s details and return to the User List Select Delete to remove the selected user from the User List A confirmation message will appe...

Страница 125: ...rinting and download 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 in...

Страница 126: ...ll 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 bla...

Страница 127: ...ser Manual for Otoport Lite model 127 Printing 12 3 When you can print The Otoport provides flexible printing options as described on the following pages Print settings are located under Configuration...

Страница 128: ...e test is saved see 11 5 4 Setup for details The test is saved and a print initiated with one key push rather than starting the printout separately 12 3 3 Printing or downloading from records Results...

Страница 129: ...hrough 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 h...

Страница 130: ...CHAPTER TWELVE Printing and downloading 130 Printing 12 3 4 Sample prints Detailed print Summary print...

Страница 131: ...ation of the printout Printouts will not complete if wireless communication is lost The Print option will be shown in green if the Otoport is currently connected to a printer wirelessly Otherwise the...

Страница 132: ...ed will be displayed Check the printer is connected correctly and switched on then re try If there is a problem connecting to the printer using the wireless method the following screen will be display...

Страница 133: ...will be stored spooled and printed when the detected condition is rectified The printer s green light will flash when a print job is being stored 12 6 Printer light summary The light at the front of t...

Страница 134: ...mall amount of paper from the roll Insert the new roll 2 ensuring the paper will pass through the paper feed 3 and close the cover with a click After loading check that the paper advances properly usi...

Страница 135: ...lso illuminate A full charge will take approximately 15 hours Charger jack plug socket The printer can be used as normal whilst charging Once fully charged the printer has enough power for around 10 h...

Страница 136: ...r or Otodynamics To change the battery pack Remove the screw 1 from the battery compartment cover TRAINING REQUIRED Push down and slide back the battery compartment cover 2 Remove the old battery pack...

Страница 137: ...system during login Each operator can be assigned a login card which the Otoport will scan and verify in order to provide access to the machine 13 2 Scanner types The Otoport has two scanning methods...

Страница 138: ...scans radio frequency identification RFID chips which can hold enough alphanumeric data for a complete patient data record on the Otoport To scan with the RFID scanner hold the card up to the Otoport...

Страница 139: ...central menu option will now change to Scan Select Scan to populate the patient details Make further edits manually with the keypad Then continue to either test or save the result as normal 13 3 2 Add...

Страница 140: ...on for more details On the New user screen select Scan The RFID method can set all user parameters For barcode scanning the user name ID and password are automatically set but the other user parameter...

Страница 141: ...initiated from within the Configuration menu the Cavity Occlusion and Real Ear tests involve running a standard TEOAE or DPOAE test 14 1 Probe test Probe Test is an option accessed from the configurat...

Страница 142: ...ress the probe firmly into the cavity until the shoulder of the probe touches the top of the cavity When released the probe will rise a little to its natural position and the shoulder may no longer to...

Страница 143: ...t are Pass The levels recorded at all frequencies are within the absolute range and within 3dB of the probe specific values Fail One or more of the levels recorded are outside the absolute range speci...

Страница 144: ...selecting Retest ensuring the ear piece is firmly inserted in the test cavity A Query result indicates that there have been changes in the probe but that these changes are not large enough to invalida...

Страница 145: ...absolute range The NEW level only is highlighted The 1 2 and 4kHz values may not be stored in the probe if a new probe is being used with the system To save new data run a Probe Test record the values...

Страница 146: ...ble Test and wait for the result to be displayed If the electrode cables are OK then a large tick is displayed on the screen If any of the cables fail the test a large cross is displayed Select Detail...

Страница 147: ...cate a large cavity volume If the result No Valid OAE is displayed and the Circles are no more than 25 percent full when the test stops the cavity test has passed If the result Stopped Too Soon Too No...

Страница 148: ...und from being emitted from the ear piece and to prevent ambient noise from being read by the microphone Then start a test as normal All the cavity size indicators in Checkfit should be filled indicat...

Страница 149: ...dult ears with no significant hearing loss produce little or no TEOAE If possible the Real Ear Test should be performed on an ear which is known to have strong TEOAEs If you are unable to achieve a Re...

Страница 150: ...body lid depending on the Otoport model purchased See chapter 2 Equipment identification for details 15 2 Probe cable clip The probe cable clip is provided to aid the practical aspects of positioning...

Страница 151: ...le 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...

Страница 152: ...orns T4 5C REF T T4 5C Fits 4 5mm ear canal Small newborns T5 5B REF T T5 5B Fits 5 5mm ear canal Most newborns T11M REF T T11M Fits 11mm ear canal Large adult ears T13M REF T T13M Fits 13mm ear canal...

Страница 153: ...8mm ear canal Most newborns R6 8B REF T R6 8B Fits 6 8mm ear canal Large newborns and first year infants R8M REF T R8M Fits 8mm ear canal Infants and small adult ears R9M REF T R9M Fits 9mm ear canal...

Страница 154: ...not to squeeze any cleaning fluid into the tubes The TEOAE tip design leaves a 0 5mm gap between the end of the coupler tubes and the end of the tip Therefore the tubes should never come into contact...

Страница 155: ...ng antiseptic wipes and dried with a tissue immediately afterwards Do not allow liquids to enter the sound tubes Coupler assembly Each coupler assembly has two sound tubes These are protected from ing...

Страница 156: ...robe fig 4 16 2 2 Reassembling the probe Fit the new coupler tubes to the probe assembly fig 1 Fit the outer shell figs 2 and 3 followed by the lid fig 4 Click the lid into place using firm finger pre...

Страница 157: ...se 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 Use without a tip or with an inc...

Страница 158: ...ther 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 b...

Страница 159: ...s cleaned if it becomes contaminated Clean surfaces of the Otoport with an alcohol based sterile wipe or cloth and antiseptic fluid Dry the Otoport with tissue immediately afterwards Do not allow liqu...

Страница 160: ...single charge with a battery life of up to 8 hours Note that the battery life depends on the Otoport usage pattern With built in power save functions and by switching the device off for the periods b...

Страница 161: ...wake up and return to the previous screen displayed If the Otoport is left for 20 minutes in standby it will turn off An audible beep will be emitted from the device for a period of 10 seconds to ale...

Страница 162: ...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 fo...

Страница 163: ...o charge the battery 18 4 2 Critical battery When the battery power reaches 7 remaining a Critical Battery warning message will appear on screen This equates to approximately 10 minutes of use Select...

Страница 164: ...charge the Otoport using the charger supplied but it is also possible to charge the device using the PC cable connected to a PC Note Do not charge more than one Otoport on the same PC at any one time...

Страница 165: ...the arrow facing upwards If the cables provided with your Otoport have a locking connector as shown below squeeze the release keys at the sides of the connector when removing the plug When the Otopor...

Страница 166: ...device is fully charged This may be convenient if you wish to leave the device charging overnight When powered by either a charger or PC the Otoport is powered from the attached device and not its in...

Страница 167: ...ystem area and then fully charging the device see chapter 11 Configuration The condition utility is available from the Configuration menu by selecting System then Battery Selecting Condition and confi...

Страница 168: ...er cable 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 The green light on the charger will illuminat...

Страница 169: ...n 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 dealer or Otodyamics for support 19 3 System...

Страница 170: ...t of an instrument fault the following message will be displayed at the start a test No stimulus will be delivered from the Otoport probe and you will not be able to start a test Turn off the device a...

Страница 171: ...uld then be turned on and off a number of times to ensure that the error doesn t reoccur If you receive the hardware fault message again contact your distributor or Otodynamics for support Error 2 The...

Страница 172: ...y 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 p...

Страница 173: ...equipment to Otodynamics for service or repair please ensure all items particularly the OAE instrument and probe are clean and free from contamination Otodynamics cannot guarantee the equipment will b...

Страница 174: ...ks see chapter 14 to ensure the instrument is working correctly In addition to this the calibration of the instrument should be periodically checked with laboratory equipment Otodynamics advises regul...

Страница 175: ...lse Waveform sample rate 20kHz Stimulus pattern Each sweep presents 8 stimuli for each to the two response buffers 16 stimuli in total The stimulus presentation pattern is X X X Y X X X Y Where Y 3X R...

Страница 176: ...stims per second Response window 2 5 12 5 ms or 4 10ms after start of stimulus Cosine filtered with rise and fall time of 2ms Response frequency bands Half octave centres at 1 1 4 2 2 8 and 4kHz Resp...

Страница 177: ...noise from the five spectral points above and the five points below the DP frequency In the Rapid noise mode the mean of these points gives the noise level In the Standard noise mode the mean of thes...

Страница 178: ...plifier gain 75dB Amplifier CMRR 60dB at 100 Hz Input impedance 1M 10 nF Amplifier noise 20 nV Hz 0 1 1 kHz Input bandwidth 150 1000 kHz Notch filter None Impedance sense current 0 2 A Impedance sense...

Страница 179: ...ting polarity The frequency dispersion of the chirp is defined by the delay at frequency T f k f d with k 0 0920 and d 0 4356 The wide band chirp waveform was cosine filtered in the time domain to giv...

Страница 180: ...differing levels of EEG noise and power line interference in which the device can be used but without any ABR actually being present It is important to note that the measured sensitivity of an instrum...

Страница 181: ...es obtained when a realistic wide range of neonate electrode noise signals i e from sleeping to restless is processed by the device As no acoustic stimulation actually reached the ear no real ABR was...

Страница 182: ...imulus at a level of 35dBnHL and a rate of 52 per second The normal distribution spread of ABR amplitudes was determined from an historical study of 3200 infant ABR recordings at 30dBHL in particular...

Страница 183: ...han 1dB Testing with a click stimulus rather than our short chirp will slightly decrease specificity because click stimuli generate a slightly smaller ABR response than a chirp of identical hearing le...

Страница 184: ...with Otodynamics UGx probes 8 pin Charging Data connector connects to Otodynamics PSU charging or to PC USB port USB 1 1or 2 0 via Data Cable Bluetooth wireless print option RFID reader option 24 1 3...

Страница 185: ...attery voltage operating range 3 4 2V Max consumption when testing 720mW Max consumption when charging 2 5W Source 1000mAh lithium polymer internal rechargeable cells Charge time 3 hours to 90 capacit...

Страница 186: ...ture range 5 to 40 Celsius Humidity 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 pressur...

Страница 187: ...ts for Medical Electrical Systems BS EN 60601 1 2 Medical Electrical Equipment Part 1 2 General Requirements for Safety Collateral Standard Electromagnetic Compatibility BS EN 60601 1 4 Medical electr...

Страница 188: ...work that supplies buildings used for domestic purposes Harmonic emissions Class A IEC 61000 3 2 Voltage fluctuations Complies flicker emissions IEC 61000 3 3 24 2 Electromagnetic Compatibility Otopor...

Страница 189: ...V line s to 1kV differential Mains power quality should line s mode be that of a typical commercial or hospital IEC 61000 4 5 2 kV line s to 2kV common environment earth mode Voltage dips 5 UT 5 UT Ma...

Страница 190: ...hnical 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 OAE...

Страница 191: ...etres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vi...

Страница 192: ...3 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation appl...

Страница 193: ...buildings used for domestic Harmonic emissions Class A purposes IEC 61000 3 2 Voltage fluctuations Complies flicker emissions IEC 61000 3 3 24 3 Electromagnetic Compatibility Otoport OAE ABR The Otop...

Страница 194: ...ine s to 1kV differential Mains power quality should line s mode be that of a typical commercial or hospital IEC 61000 4 5 2 kV line s to 2kV common environment earth mode Voltage dips 5 UT 5 UT Mains...

Страница 195: ...nical specifications The following functions of the Otoport OAE ABR are deemed essential performance and were tested for immunity in compliance with IEC60601 1 2 a The collection of Otoacoustic Emissi...

Страница 196: ...res m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vici...

Страница 197: ...radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey s...

Страница 198: ...1 1 2 2 1 3 5 3 5 7 10 11 11 22 100 35 35 70 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation ap...

Страница 199: ...by the probe sealed in the ear canal by its tip d e Calibration cavity and measurement type For the purposes of EN60645 3 calibration was performed in an occluded ear canal simulator conforming to IE...

Страница 200: ...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 g Polarity of stimulus The polarity of the s...

Страница 201: ...ors 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...

Страница 202: ...explanations Class II Type BF Bluetooth enabled RFID enabled Caution USB 1 1 When discarded the item must be sent to separate collection facilities for recovery and recycling Probe socket Battery cha...

Страница 203: ...ort Lite model 203 Technical specifications Refer to operating instructions Otodynamics factory address Product catalogue number Product date of manufacture Product serial number RF transmitter Traini...

Страница 204: ...canning 137 Battery 45 118 160 Beep 64 69 Blue LEDs 40 Bluetooth 119 125 Brightness 117 Buttons 37 C Calendar 185 Cancelling the test 65 70 Cavity test 147 Certification 27 30 Changing probe coupler t...

Страница 205: ...17 Electrodes 35 51 Electrode sockets 28 Electrode test 146 End data 120 Entering characters 38 Entering dates 39 Environmental 186 Environment checks 48 Equipment 17 Extend 104 F Fail 143 Fault mess...

Страница 206: ...t lock up 169 P Paper 134 Pass 143 Password 46 Patient list 98 Pausing the test 65 70 Poor probe fit 66 71 Power 185 Precautions 12 Printer battery 136 Printer fault detection 133 Printer light summar...

Страница 207: ...59 Stimulus frequencies F2 177 Stimulus LED 40 Stimulus pattern 175 Stimulus repetition rate 176 Switch on 44 Symbol explanations 202 Symbols 26 System 116 117 System details 169 T TC 88 Template cor...

Страница 208: ...CHAPTER TWENTY FIVE Index 208 Index...

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