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Guidance and manufacturer’s declaration – electromagnetic immunity

The Otoport OAE+ABR is intended for use in the electromagnetic environment specified below. The 

customer or the user of the Otoport OAE+ABR should ensure that it is used in such an environment.

Immunity  

IEC 60601   Compliance 

Electromagnetic environment -

test 

test level 

level 

guidance

  

 

 

Portable and mobile RF communications equipment 

  

 

 

should be used no closer to any part of the Otoport  

  

 

 

OAE+ABR including cables, than the recommended  

  

 

 

separation distance calculated from the equation  

  

 

 

applicable to the frequency of the transmitter.

  

 

 

Recommended separation distance

Conducted RF 

1 Vrms 

1 Vrms 

d

 = 3.5√

P

 

IEC 61000-4-6 

150 kHz

  

to 80 MHz

Radiated RF 

1 V/m 

1 V/m 

d

 = 3.5√

P

 80 MHz to 800 MHz

IEC 61000-4-3 

80 MHz  

 

d

 = 7√

P

 800 MHz to 2.5 GHz

  

to 2.5 GHz

  

 

 

where 

P

 is the maximum output power rating of 

  

 

 

the transmitter in watts (W) according to the 

  

 

 

transmitter manufacturer and 

d

 is the 

  

 

 

recommended separation distance in metres (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 vicinity of 

  

 

 

equipment marked with the following symbol:

 

  

The conducted and radiated RF immunity levels are less than the IEC 60601 test levels. This is because the 

Otoport OAE+ABR depends for its operation on the measurement of very low level physiological signals. 

Two physiological signals are measured: an electro-physiological (ABR) signal of about 0.01 FemtoWatts 

(giving about 100nV RMS across 1K); and, an acoustic signal of about 0.1 FemtoWatt acoustic power 

(giving about 700nV RMS across 5K input impedance). It is impractical to measure these signals in the 

presence of RF energy at the IEC 60601 test levels.

At high levels of RF energy both the ABR and OAE tests will be paused by the artifact rejection functions of 

the instrument - it will go into ‘reject mode’. If this occurs then either the source of RF energy should be re-

duced or the measurement should be taken further from the source. In practice this means either switching 

off other equipment (for example, mobile phones and noisy wall plug power supplies) or moving to another 

location.

Technical specifications

Otoport OAE+ABR

User Manual for Advance and Screener

Содержание Otoport Advance

Страница 1: ...Otoport OAE ABR Otoport Advance model Issue 8 1 Otoport OAE ABR User Manual for Otoport Advance model...

Страница 2: ...rds Doc Ref MANOA BK 8 1 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 Otodynamics Ltd Co...

Страница 3: ...d in OAE and OAE ABR kits 24 2 4 Optional accessories 27 2 5 Controls indicators and connections 29 2 6 Scanner 30 2 7 OAE labelling 31 2 8 Otoport OAE ABR controls indicators and connections 33 2 9 A...

Страница 4: ...5 3 Tip selection and probe fitting 61 5 4 Helpful hints 63 5 5 Electrode fitting 64 6 Test troubleshooting 67 6 1 OAE test problems 67 6 2 ABR test problems 68 6 3 OAEs and screening 70 7 Testing op...

Страница 5: ...Checkfit 112 11 4 ABR test 114 11 5 Bilateral ABR testing 120 12 Saving a test 122 12 1 Test review screens 123 13 Multi Test 124 14 Records 126 14 1 Records menu 126 14 2 Find patient 127 14 3 Work l...

Страница 6: ...her settings 179 17 10 ABR Other settings 181 17 11 Multi Test config 183 17 12 Test setup defaults 184 18 Transfer printing and downloading 193 18 1 Bluetooth wireless printing and download 193 18 2...

Страница 7: ...aning 234 22 2 Changing probe coupler tubes 234 22 3 Probes safety note 236 23 Care of the Otoport 237 23 1 Use of the Otoport and cleaning 237 24 Otoport power 239 24 1 Battery life 239 24 2 Initial...

Страница 8: ...264 30 1 Confidence levels in DPOAE tests 264 30 2 Confidence levels in TEOAE tests 267 30 3 Conclusions 269 31 Technical specifications 271 31 1 General 271 31 2 Electromagnetic Compatibility Otopor...

Страница 9: ...re automatically interpreted and a clear Pass or Refer result is presented to the user who will be a trained screener audiologist or medical professional Use of the device is indicated when the patien...

Страница 10: ...and the patient should be very quiet and still during the test The device will clearly indicate levels of acoustic noise and electrical interference with ABR Use this as a guide to improve the testin...

Страница 11: ...circumstances either an equipment fault or failure to comply fully with the instructions in this manual may result in unreliable test results Results with total OAE responses greater than 40 dB SPL sh...

Страница 12: ...ng loss Damaged outer hair cells do not produce emissions so cochlear hearing loss is associated with reduced or absent otoacoustic emissions Damage can occur to one part of the cochlea while other pa...

Страница 13: ...specific frequencies f1 and f2 to stimulate the cochlea The instrument records the distortion generated when outer hair cells respond to the stimulus combination Pairs of f1 and f2 at different freque...

Страница 14: ...blishing the extent of cochlear pathology Recordings can be concentrated on selected frequency ranges When used with lower stimulus levels DPOAEs are just as sensitive to slight hearing losses as TEOA...

Страница 15: ...t F2 F1 1 22 This is the ratio that gives the greatest DPOAE response at the frequency 2F1 F2 The 2F1 F2 response is believed to originate largely in the region of the cochlea which is most sensitive...

Страница 16: ...rred to as fine structure this interference is very dependent on frequency so small changes in test frequency can enhance or depress the OAE level recorded with the change having no bearing on cochlea...

Страница 17: ...and optimum increment in L1 over L2 become smaller 1 5 3 DP level and test sensitivity Higher DP stimulus levels result in tests that are less sensitive to small amounts of cochlear damage but nevert...

Страница 18: ...mplex but with systematic changes in L1 and L2 the change can often be linear This linear relationship can be used to provide a slope or gradient measure which gives the change in DPOAE for a given ch...

Страница 19: ...s still very inaccurate One limitation is that the exact combination of L1 and L2 levels that gives the greatest DP may vary between individuals Another is that inner hair cell sensitivity is a major...

Страница 20: ...f the stimulus depending on frequency and intensity of the stimulus Voltages potentials can be measured at the skin with surface electrodes the electrode montage consisting of three such electrodes As...

Страница 21: ...e of the equipment may also be provided by previously trained staff and qualified audiologists Ensure your local policy for infection control is followed as well as reading the recommendations in this...

Страница 22: ...ly in Otoport OAE ABR kit REF ADV ABR Otoport Advance OAE ABR or REF SCR ABR Otoport Screener OAE ABR REF ABR SK Starter kit of electrodes pack skin preparation gel and pack of cotton wool pads REF AB...

Страница 23: ...EF OSC S Otoport Screener REF OAE CAV Probe test cavity REF ABR CAV Probe cavity and ABR cable tester REF ABR INF Infection control sleeve for Otoport OAE ABR unit only 2 2 Supplied only in Otoport OA...

Страница 24: ...R POUCH Drawstring probe pouch Re order quantity 10 REF PR UGD UGD DPOAE probe Supplied with Otoport Advance 2 3 Supplied in OAE and OAE ABR kits REF OP CAS Equipment case for Otoport OAE kit REF PR U...

Страница 25: ...S probe body and lid x 1 Supplied with Otoport Screener Re order quantity 10 TPC probe coupler tubes x 5 See chapter 22 for fitting instructions Re order codes REF TPC 10 quantity 10 REF TPC 100 quant...

Страница 26: ...d REF OP CAB PC downoad cable REF OTOLINK Otolink software CD REF ODS Docking station Supplied with Otoport Advance Provides connections for printing charging and downloading to PC REF OP INF Infectio...

Страница 27: ...s with additional compartment for printer Documentation pack Includes instrument and software manuals quickstart and probe use guides REF ODS Docking station Optional accessory for Otoport Screener Pr...

Страница 28: ...P R Otoport printer paper rolls Quantity 8 REF OMP CAB R Otoport printer cable For use with Otoport Advance and Otoport Screener OAE devices not for use with ABR REF OMP CHG R Otoport printer charger...

Страница 29: ...u selection keys Arrow up down left right navigation keys Data entry keypad Charging status indicators Speaker Charger and PC cable socket On Off power key 2 5 Controls indicators and connections Equi...

Страница 30: ...CHAPTER TWO Equipment identification 30 Barcode RFID scanner not included as standard 2 6 Scanner Grip strip Equipment identification...

Страница 31: ...s one or more of the following symbols DC Caution Refer to user manual Class II electrical protection double insulated Type BF applied part Bluetooth enabled RFID enabled Equipment identification Otop...

Страница 32: ...onth of manufacture yymm and unique manufacture ID xxxx The complete serial number is therefore OXX yymmxxxx 0120 2 7 2 Certification or regulatory marks The label features one or more of the followin...

Страница 33: ...s and electrode sockets Impedance check indicator LEDs Quick release clips Otoport unit Otoport controls and keypad USB PSU connected and battery charging indicator LEDs Charger PC cable socket Equipm...

Страница 34: ...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 Type BF applied part Manufacturer...

Страница 35: ...21 Serial numbers 1234 Otoport 1234 ABR if ABR module is supplied 240 Additional product ID BRT used to identify any hardware modules fitted 250 Secondary serial number AB1 This is a proprietary elect...

Страница 36: ...sembling the ABR Module with an Otoport The ABR Module is designed to be fitted as a sleeve to an Otoport unit as described in the following instructions Do NOT force the Otoport into the ABR sleeve 3...

Страница 37: ...e 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 of the ABR Module forward so that it is level with the Oto...

Страница 38: ...port 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 the ABR Module is inserted i...

Страница 39: ...ve 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 an Otoport OAE ABR with a permanently fitted sleeve someti...

Страница 40: ...he top end of the module 3 4 1 Connecting the probe Follow instructions for connecting the probe to the Otoport in section 3 8 If you are using two probes ensure that the probe head colour matches the...

Страница 41: ...wired 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 an...

Страница 42: ...re using your Otoport for the first time fully charge the unit See chapter 24 Otoport Power for details 3 6 Quickstart Quickstart guides for OAE and ABR tests included as separate items in your docume...

Страница 43: ...ayed while system checks are per formed 1 Use the buttons to select TEOAE or DPOAE Test modules 2 Select QUICK with the button to view the test menu 1 Select an appropriate DP tip blue 2 Fit the DP ti...

Страница 44: ...t a band meets stop criteria 3 The test result will be displayed at the top of the test screen Press the button for SAVE options 2 Use the buttons and keypad to enter patient details Press to SAVE 1 P...

Страница 45: ...the and buttons to select the test mode knurled sleeve 1 Select an appropriate tip 2 Fit the tip to the earpiece 3 Fit the earpiece in the ear canal 3 A vertical stimulus needle and low noise with tw...

Страница 46: ...auto stop and a result graphic will be shown Press the button to review the result Step 4 Saving patient and test details 6 The test result will be displayed at the top of the test screen Press the bu...

Страница 47: ...w buttons to navigate to the ABR screen 4 Choose ear tested by using the and arrow buttons and confirming with the button to complete and save the test 3 Enter patient and test details using the keypa...

Страница 48: ...nctions vary from screen to screen but generally the right circle key provides affirmative options and the left square key provides negative options 3 7 2 Arrow navigation keys The arrow navigation ke...

Страница 49: ...bsequent characters lower case is shown first e g abcABC2 More characters can be stored than can be displayed on the screen Arrows are displayed to indicate that the string continues to the left or th...

Страница 50: ...ayed or press Cancel to ignore the changes If the date has not been edited it will remain as dd Mmm yyyy For Date of Birth entry D O B the Otoport will not permit entry of a future date Invalid D O B...

Страница 51: ...the keypad data entry function or deleted with the delete key Continue to press delete to erase characters to the right of the cursor 3 7 8 Backlight The screen and keypad are backlit to assist in te...

Страница 52: ...d range It is extinguished if the stimulus is outside range During testing this is the range defined in Test setup see chapter 17 The Noise OK LED is highlighted with an N It is lit when the noise lev...

Страница 53: ...the probe socket on the Otoport Align arrow with front of Otoport It is possible to feel when the probe key is aligned as the probe will mate with the socket easily Arrow The arrow at the front of the...

Страница 54: ...obe Turn knurled sleeve anti clockwise 3 9 Disconnecting the probe To disconnect the probe unscrew the knurled sleeve in an anticlockwise direction until the thread is disengaged Turn knurled sleeve c...

Страница 55: ...robe socket Important Note 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 probe and will invalidate the probe warra...

Страница 56: ...e display screen will show Switch Unit On Select Yes to confirm Otoport switch on or No to turn the unit off again If Yes or No are not selected within two seconds of pressing the on off power key the...

Страница 57: ...A battery graphic will appear to the right of the logo to provide an indication of the Battery power remaining Please refer to chapter 24 Otoport power for battery information The date and time are al...

Страница 58: ...ta 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 field To review chara...

Страница 59: ...tch on The DPOAE Test screen Otoport Advance only ABR Test screen and other module screens can be accessed using the left right arrow keys Choose Select to enter each menu OTOPORT ADVANCE ONLY OTOPORT...

Страница 60: ...he 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 ABR Try to mi...

Страница 61: ...nters the probe sound tubes do not attempt to clean them the coupler tubes should be changed The correct size tip will look slightly larger than the ear canal and should fit snugly forming a complete...

Страница 62: ...for more information on probe tips The probe may be inserted into the earcup before or after applying the earcup to the infant Push the probe into the ear cup until the front face of the tip is flush...

Страница 63: ...often cleared by feeding or turning the baby If there is no success during the first OAE testing attempts a second OAE testing session when the ear has had time to clear usually brings success Babies...

Страница 64: ...kes 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 gauze pad to remove any res...

Страница 65: ...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 negative white High forehead positive red The sensor should be...

Страница 66: ...r the electrode placements described above Alternative placements are possible including Recommended Alternative 1 Alternative 2 Positive Red High forehead High forehead High forehead Negative White N...

Страница 67: ...lear Babies are best tested when they are sleeping or sleepy and successful OAE recordings are most often made one hour after a feed The baby may settle down more easily if swaddled Babies older than...

Страница 68: ...ecially 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 open a fresh pouch if in doubt ab...

Страница 69: ...secure 2 Switch off any non essential equipment in the room 3 Do not use mobile cellular phones when operating the equipment 4 Separate the electrode cables from the probe cable if intertwined 5 Move...

Страница 70: ...y 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 The specific risks must be e...

Страница 71: ...ils This option gives the user flexibility when testing conditions are variable At the end of the test select Save to access the Save Options menu The Select button will enable you to enter patient de...

Страница 72: ...e only option on the Multi Test screen Advance only is to enter patient details or select a patient before testing You will not be able to start a test if the Otoport is connected to a PC or charger O...

Страница 73: ...nt The device will check that the previous patient has test data for both the left and right ears If only one test has been saved then a pop up message will appear stating Only RIGHT LEFT Ear Test Sav...

Страница 74: ...tient stored in the worklist 8 1 Entering patient data The Enter Details screen allows patient data to be entered and saved with the test record Patient details fields Fields can be selected by pressi...

Страница 75: ...20 First The patient s first name 20 D O B The patient s date of birth n a Gender The patient s gender n a Mother The mother s maiden name 20 Notes Any additional comments relating to the patient 15...

Страница 76: ...t Ear or press the left menu selection key or the left arrow key to select the Right Ear ABR tests run using ear cups may be run bilaterally on both ears so a third option BOTH can be chosen Further i...

Страница 77: ...g Test on the patient details screen the test choice screen is available 9 1 Test choice Choose a TEOAE test from the list using the arrow keys then press Select Descriptions of the test modes are giv...

Страница 78: ...on the click stimulus level required to give 84dBpe in the ear canal Large ear canals such as found in adults require a large stimulus and fill the bar Small ear canals such as found in neonates requ...

Страница 79: ...s the bar should be consistently below the Noise Reject Level which is represented by the horizontal line across the Noise Level Indicator The bar is filled red if the level is above the threshold and...

Страница 80: ...o Patient Details Stim out of Range will appear if Start is selected when the stimulus is outside the accepted range It is advisable to select Back to return to Checkfit and readjust Select Continue t...

Страница 81: ...e fit of the probe and the geometry of the individual ear canal The stimulus spectrum should be a smooth rounded curve A jagged stimulus response in the low frequencies or a sharp peak in the mid freq...

Страница 82: ...sents the OAE signal level within each band and the red section represents the noise level at that frequency A tick will appear above a bar if the TE in the half octave band has met its Stop criteria...

Страница 83: ...e noise level during a test The noise reject level is displayed numerically below the indicator Use the up down arrow keys to adjust the noise reject level Cancel and End Select Cancel at any time dur...

Страница 84: ...en quite irregular and should not be interpreted as showing variation in cochlear health at a fine frequency resolution However changes in the detail may relate to changes in the cochlear status TEOAE...

Страница 85: ...window and low frequencies later Waveforms dominated by a single frequency may be the product of strong spontaneous OAEs Waveforms dominated by a single frequency which decays rapidly may be due to a...

Страница 86: ...tave frequencies The following table describes each field Field Description Signal The signal level recorded in dB SPL Noise The Noise levels recorded in dB SPL SNR The Signal to Noise Ratio signal mi...

Страница 87: ...elation of the two OAE waveforms Time Test time seconds Stim The Checkfit Stimulus level dB pe Probe The probe serial number n a File The unique test file name populated on Save 9 3 6 Test stop reason...

Страница 88: ...tions were acceptable Noisy If the noisy data collected is three times greater than the low noise data collected Poor Probe Fit If the final test stimulus level is outside the stimulus ok range or if...

Страница 89: ...her the Quick option or selecting Test on the patient details screen the test choice screen is available 10 1 Test choice Choose a DP mode from the listed test modes using the arrow keys then press Se...

Страница 90: ...Setting low and high frequencies focuses testing on the region of interest and enables testing to be completed more quickly Then select the frequency resolution points per Octave Pts Oct for your test...

Страница 91: ...ck level will auto adjust if stimulus levels are stable If levels do not auto adjust the user can force adjustment by selecting Adjust using the middle diamond menu key If Autostart is on the test wil...

Страница 92: ...s vertical The white line and number represent the stimulus from channel A while the yellow line and number represent channel B Noise level indicator A Noise Level Indicator is shown on the right of t...

Страница 93: ...response The two waveforms displayed should be very similar Significant differences between the two may be the result of a poor probe fit or a blockage in the probe 10 2 3 Stimulus spectrum display Th...

Страница 94: ...probe faults 10 2 4 Test condition information Checkfit OK will appear at the top of the screen if the adjusted stimulus level is correct and the noise is consistently below the reject level Noisy ap...

Страница 95: ...l return to the checkfit screen Note The calibration method used for DP stimuli above 5kHz has been enhanced from firmware version 1 14 0 0 onwards If necessary for comparison with old recorded data t...

Страница 96: ...two screens display the same test data graphically either as a line graph or a bar graph The blue dots or bars at each frequency show the DPOAE signal level and the red section represents the noise l...

Страница 97: ...anual When this frequency test loop has been repeated twice default see Min Loops in Test setup chapter by selecting Go manual the user has the option to change the test frequency with the left and ri...

Страница 98: ...pause the test This may be useful if the ambient noise increases Cancel Test is displayed at the top of the screen and three options are provided Yes will terminate the test No will continue the OAE r...

Страница 99: ...r canal at these frequencies mean that the stimulus levels recorded at the probe may be considerably lower than the stimulus level at the tympanic membrane Due to this for frequencies above 5000Hz the...

Страница 100: ...equency F2 kHz Level L2 5 2 5 6 5 9 6 1 6 4 6 7 7 0 7 3 7 6 8 0 65dBSPL 10 10 10 10 10 10 10 10 10 10 70dBSPL 10 10 10 7 8 10 9 8 10 10 75dBSPL 10 10 2 6 7 10 8 7 7 10 For DP Zoom DPZ tests the data f...

Страница 101: ...ary scale 1 9 where 1 small neonate ear and 9 large adult ear Time Time elapsed since start of data collection seconds Probe The probe serial number File The unique test file name populated on Save 10...

Страница 102: ...or a positive OAE result or a double beep for a negative OAE result When the test stops a result graphic is displayed on the screen example below Select OK to accept the test stop reason The result is...

Страница 103: ...three times greater than the low noise data collected Poor Probe Fit The final test stimulus level is outside the stimulus ok range or the final stimulus STMOK value is 85 Too Few Bands Insufficient...

Страница 104: ...as been found to be correlated to the threshold of hearing but there are other factors and considerable variation between individuals so DP threshold cannot be used as a reliable indicator of hearing...

Страница 105: ...an R2 of 1 A value of R2 close to 0 indicates that the line is a very poor fit to the data A low R2 value means that test results depending on the fit of the line to the data such as Thresh and Slope...

Страница 106: ...epending on the test setting see chapter 17 Test set up If the uPa scale is used then the range is auto adjusted between 0 30 and 0 200 uPa depending on the largest DPOAE signal or noise level recorde...

Страница 107: ...est choice screen is shown 11 1 Test choice Choose an ABR mode from the listed test modes using the arow keys then press Select Descriptions of the test modes are given in section 17 10 1 If the ABR m...

Страница 108: ...e 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 conditions are mo...

Страница 109: ...on the screen will show the problem It will tell you if EEG Noise Powerline Noise or Impedance are preventing the test from starting Try to resolve the issue so that testing can start If any electrod...

Страница 110: ...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 impedances are optimum or...

Страница 111: ...rence from electrical noise and or one or more of the electrodes is poorly connected has high impedance If impedance levels are acceptable but the PN noise level remains high try Turning off or moving...

Страница 112: ...s depends on the Ear Cups setting in Test Setup see chapter 17 Ear Cup mode set to On With Ear Cups set to On the Otoport will check whether the stimulus level recorded is consistent with ear cup use...

Страница 113: ...mode Ear Cup mode set to Auto With Ear Cup mode set to Auto the Otoport will first assess size of the cavity the probe is in If the cavity is large it will ask the user if ear cups are being used If t...

Страница 114: ...ircle is filled there is a ABR response present when the blue NLO bar is filled a full set of data has been recorded but no response has been detected or when test noise ABR noise has become so low th...

Страница 115: ...to high electrical noise levels Accepted Shows the number of sweeps accepted into the average Rejected Shows the number of sweeps rejected due to high electrical noise levels ABR Noise Shows the estim...

Страница 116: ...noise 11 4 3 Stimulus monitoring At intervals during the testing the acoustic stimulus level is checked If the stimulus level has changed the Check Probe Fit message is shown If the environment has b...

Страница 117: ...d electrical noise is monitored as in section 11 2 2 Failure to measure discernible ABR data within the defined test time and within acceptable NLO range will return a Refer result Failure to measure...

Страница 118: ...data collected has not met the set pass criteria and the test conditions were acceptable Noisy The noisy data collected is three times greater than the low noise data collected Poor Probe Fit The las...

Страница 119: ...end of the test were high and may have prevented an ABR from being recorded This could be caused by electrodes becoming disconnected from the patient during testing High EEG Noise Electrical noise dur...

Страница 120: ...sts on both ears in sequence right ear then left ear Ear cups are recommended for bilateral testing and both ears should be prepared before testing commences The current test ear is indicated during t...

Страница 121: ...en together The same stop reason graphics used for single ear tests see section 11 4 7 ABR test results are used for the Right and Left ear results It is not possible to review bilateral ABR tests in...

Страница 122: ...is completed select Save to save the result the display will vary depending on the type of test performed Select Cancel to discard the result a confirmation screen is provided which gives the option t...

Страница 123: ...t arrow keys can be used to toggle between the test screen choices Select Retest to repeat the test Select Print or PC Load to print or download the patient details and test result see chapter 18 Tran...

Страница 124: ...olling modules Enter Patient Details see chapter 8 Select the test ear see chapter 12 The test ear is selected before the test begins rather than after as for other test modes so that tests may then p...

Страница 125: ...ultiple loops have been set see Multi Test Config section 17 11 a summary screen is shown after each loop is completed When Multi Test has ended a summary screen shows the number of tests and the numb...

Страница 126: ...the database Select Work List to edit or add a new patient to the Worklist The Worklist can be reviewed and a patient selected to test Select Summary for information on the current records in the dat...

Страница 127: ...de the option to search for patient tests within the specified date range Enter a date in D O B to filter by date of birth The number on the right at the top of the screen shows the number of patients...

Страница 128: ...other Patient Records not currently visible on screen Use the up 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 Us...

Страница 129: ...n Press the up down arrow keys to scroll between tests The test number will increment accordingly The up and down arrow indicators to the left of the screen show that other Test Results are available...

Страница 130: ...est Total noise level dB SPL Date of test Total OAE signal level dB SPL Test mode Set stimulus level DPOAE test summary screen Patient s family name Current test of total number of tests Band pass ind...

Страница 131: ...ch set signal and SNR criteria Number of points tested DP Growth test summary screen Patient s family name Current test of total number of tests Test type Ear tested R Right or L Left Date of test Tim...

Страница 132: ...s family name No of Test saved to the patient record Test Result Ear Tested R Right or L Left Test duration Date of Test Time of Test User ID Test type Stimulus level Pass criteria Test progress indic...

Страница 133: ...shown on various test screens Please refer to chapters 7 and 8 for a full description of the screen displays for the relevant test type Use the left right arrow keys to scroll between the screens Sele...

Страница 134: ...cting Detail in the Patient List Please refer to chapter 6 Patient Details for a full description of the screen format Select Test to start the test for this patient Please refer to chapter 7 TEOAE Te...

Страница 135: ...ntly held in the worklist The user will be prompted to confirm the erase before the operation is completed Select Back to return the Records Menu 14 3 1 Add patient A new patient can be added to the c...

Страница 136: ...e again 14 3 2 View work list The Work List displays the ID and Family name of each patient to be tested The format of the Work List is identical to the Patient List Use the up down arrow keys to scro...

Страница 137: ...efer to chapter 6 Patient Details for guidance on field entry and format Select Save when changes to the Patient Details have been made A pop up message may appear if edits to mandatory fields e g ID...

Страница 138: ...summary A database Summary can be accessed from the Records Menu screen It details the present number of Patients and Tests saved to the database The Otoport can store up to 1024 patient records and o...

Страница 139: ...tests stored in the database It is then necessary to confirm the erase request to help eliminate accidental deletion Select Yes to Erase all tests or No to leave the records stored on the Otoport Rec...

Страница 140: ...ss and timing of the Backlight Select Battery to view current battery status System Details displays information for Otodynamics engineers Select About for Otoport firmware revision number and issue d...

Страница 141: ...and keypad backlights Select Back at any time to return to the System Menu 15 2 1 Volume Use the left right arrow keys to decrease or increase the Volume level To turn the sound off press the left arr...

Страница 142: ...light Use the left right arrow keys to toggle between the Backlight control choices for the screen and keypad The backlight can be configured to be either always on or off or on for a limited period o...

Страница 143: ...after a limited period of time When the screen Backlight turns off the operation time will increase as a consequence of a change in power requirement This difference in calculated time will show the b...

Страница 144: ...nformation for Otodynamics engineers The device performs electrical self checks and any errors during these tests are displayed see section 25 3 in Troubleshooting for further details 15 5 About The A...

Страница 145: ...enter custom Facility or Risk Factor options Select Date Time to adjust the date and time settings Select Other Options to alter patient ID format add a site and device identification which are then s...

Страница 146: ...and allows password control of areas such as test setup Select View Users to review edit or delete users from the current User List Select Login to turn the login function on or off Select Back to ret...

Страница 147: ...igurable choices NICU Are patients tested by this user N A predominantly in the neonatal intensive care unit Yes or No The User ID is added to a saved test record to identify the user who performed th...

Страница 148: ...List will appear with the newly saved user highlighted on screen The message Cannot Save Please enter Name and User ID may appear on press of Save if either of these two fields have been left unfille...

Страница 149: ...he selected user from the User List A confirmation message will appear at the top of the screen Select Yes to confirm the deletion or No to retain the user and return to the Edit User screen It is not...

Страница 150: ...a User from the choice bar if necessary Once a User is selected use the arrow keys to return to the password entry row and the data entry keypad to enter a corresponding Password To improve security d...

Страница 151: ...ger than 10 characters and identify the hospital clinic or other locality where the device is to be regularly used These options are then presented in the Facility choice bar when entering new Patient...

Страница 152: ...the list of 15 risk factors available The name chosen to identify each risk factor should be no longer than 12 characters Select Save to save changes to the Risk Factors list and return to the Default...

Страница 153: ...arrow keys to jump between the Day Month Year and the up down arrow keys to select the required date The date format can be changed from dd Mmm yyyy to dd mm yyyy or mm dd yyyy for use in the USA Sel...

Страница 154: ...hen adding new Patient Details characters will be restricted for Patient ID input according to the chosen format Below is a table listing the options available ID Format Description 123 Numeric only 1...

Страница 155: ...code such as yellow blue etc The Device ID will be saved to each test record so it cannot be changed until all data has been downloaded from the database and the database has been cleared Select Save...

Страница 156: ...BR detection logic where the device will automatically end the recording when the criteria have been met There are 15 separate test modes four TE eight DP Advance only and three ABR twelve of which ma...

Страница 157: ...see all the modes Switch each mode On or Off using the arrow keys Select Save to keep any changes you have made to the modes available at the start of a test A message confirming the save will be show...

Страница 158: ...ry modes 17 3 Test config Various test parameters can be configured in this area Up and down arrows on the screen indicate other fields are available but not currently visible Use the up down navigati...

Страница 159: ...reject level will allow more data to be collected in noisy conditions This could have a negative affect on data quality as it could contain more noise and there is an increased risk of noise artefact...

Страница 160: ...narrower frequency range of emissions but includes the period in which the largest emissions are generally recorded Because it includes only the period when emissions are strongest this setting can im...

Страница 161: ...lect the parameter to edit and to move between the Low and High columns and left right arrow keys to edit the settings Move down at the bottom of the High column to edit the Low column Select Back and...

Страница 162: ...se floor in DP tests is calculated The Standard mode implements a noise floor which is appropriate for clinical measurements in which high accuracy in terms of the dBSPL of the OAE is required at each...

Страница 163: ...ep takes 80ms so Time Point options are multiples of 80ms Range 0 32s 4 sweeps 0 64s 8 1 28 16 2 56 32 5 12 64 or 10 2s 128 Freq range The f2 frequencies at which testing will take place 1 1 5 2 3 4 a...

Страница 164: ...L1 levels are set by the parameters Max L2 70 L1 and Step L2 5 L1 Field Description Max L2 70 L1 The highest intensity of L2 is fixed at 70dBSPL The highest intensity of L1 is presented here Range 75...

Страница 165: ...the levels presented would be L1 L2 70 70 65 65 60 60 55 55 50 50 45 45 Alternatively if Max L2 70 L1 67 and Step L2 5 L1 2 then the levels presented would be L1 L2 67 70 65 65 63 60 61 55 59 50 57 45...

Страница 166: ...give a larger ABR response for the same stimulus level Stim level Peak target stimulus level for testing Range 5 60 dBHL In ear cup mode the stimulus level limits are 40dBHL when the stimulus type is...

Страница 167: ...7 7 1 OAE Stop criteria When Setup Bands is selected a pop up table enables the edit of each band criteria Use the up down arrows to select the parameter to edit and to move between the SNR and RQRD r...

Страница 168: ...signal required Range 0 to 20 or Off Min band sig The minimum level of OAE signal required in each band Range 10 to 20 or Off Pass bands The minimum number of band passes required in order to meet the...

Страница 169: ...s Min OAE Minimum OAE Total OAE summed across all frequencies required Range 10 to 20 or off Min band Minimum signal at any frequency required Sig Range 10 to 20 or off Pass bands The number of DP fre...

Страница 170: ...ent selecting the frequencies with a dot using Go Manual will increase their NLo count and trigger autostop 17 7 2 Display logic DP Growth tests In the DP Growth section the Stop Criteria section is r...

Страница 171: ...evel is always reported in dBSPL The DPOAE level can be displayed on either a logarithmic dBSPL scale or an absolute sound pressure micro Pascal Pa scale The dBSPL DP intensity scale cannot represent...

Страница 172: ...mistaken for an ABR The minimum fixed Fsp threshold is higher than the largest Fsp ever likely to be achieved by chance in EEG noise The minimum TC requirement should be achieved when recording an ABR...

Страница 173: ...ons PC2 is designed for neonate screening and is the default setting for the ABRscreen mode PC3 and PC4 may give higher specificity in challenging noise environments potentially passing healthy ears s...

Страница 174: ...n Use the up down arrows to highlight a setting and use the left right arrows to change the choice bar setting 17 8 1 TE automation Auto Start With Auto Start On the stimulus level will automatically...

Страница 175: ...obe fit is stable Select ADJUST to manually initiate stimulus adjustment If Autoadjust is Off it is necessary for the operator to select ADJUST during the test Checkfit stage This will initiate the st...

Страница 176: ...t stage Auto Stop With Auto Stop On the test will stop when the Stop criteria are met or when all frequencies have met the NSE Smart criteria or the Stop criteria see below Auto Stop is not available...

Страница 177: ...setting a high value for NSE Smart might prevent a frequency or level from being tested for long enough to reveal a valid OAE If using Auto Stop the highest level at which NSE Smart can be securely s...

Страница 178: ...conditions are good If Auto Start is OFF the tester determines when to proceed from Impedance Check to data collection manual start Auto Stop The Auto Stop setting controls whether the test automatica...

Страница 179: ...ng the data With Mandatory Save Off it is possible to Cancel the test or abort the data saving process 17 9 2 TEOAE Mic filter It is possible to select various Mic Input Filters on the Otoport which c...

Страница 180: ...ld be used if the 6k Band see 17 3 Test configuration is turned on as it gives the least high frequency attenuation 0 8 4 8k 841 4757Hz Attenuates OAE signal and noise collected at 1 and 4Khz by a few...

Страница 181: ...greater than around 0 5cc will trigger the warning With Neonate setting Off no warning message is displayed if a large ear volume is detected 17 10 2 ABR Mains ABR mains sets the ABR test configurati...

Страница 182: ...Mains setting Note that changing the setting of ABR mains in one test mode will also change the setting in other ABR test modes 17 10 3 Ear cups This setting allows the use of ear cups and it can be...

Страница 183: ...intervals For example to investigate how TEOAE responses change while a subject is sleeping 17 11 1 Test 1 4 Use the left and right arrow keys to select among the test modes available on the Otoport w...

Страница 184: ...ptions Below is a description of each of the default modes available with the mode settings detailed in the tables following TE Modes Screening mode is designed for rapidly detecting the presence of T...

Страница 185: ...ch stops the test when an OAE has been detected High mode is designed for general clinical DPOAE measurement in the range 1 5 8kHz using high stimulus levels 70 70 Users manually start and end the tes...

Страница 186: ...Newborn Hearing Screening 2014 Some major infant screening programs use 40dBHL e g in UK Screening with stimulus levels above 40dBnHL will miss some mild hearing losses The ABR Custom mode is not int...

Страница 187: ...HL adult ears up to the volume of a neonate screening ear cup The Otoport OAE ABR is capable of recording ABR responses from patients of all ages provided a non template Fsp only pass criteria is sele...

Страница 188: ...OFF 6k Band OFF OFF OFF OFF TE Stop criteria Min NLo 30 30 40 40 Min OAE Sig 0dB SPL 0dB SPL 0dB SPL 0dB SPL Min SNR 6dB OFF OFF OFF Min Band Sig 5dB 5dB 5dB 5dB Pass Bands 1 3 2 3 Band Settings SNR R...

Страница 189: ...1 2s Min OAE Sig OFF OFF OFF OFF Min Band Sig 5dB SPL 5dB SPL 5dB SPL 5dB SPL Pass Bands 3 3 3 3 Band Settings SNR Rqrd SNR Rqrd SNR Rqrd SNR Rqrd 1K 6 NO 6 NO 6 NO 6 NO 1 5K 6 NO 6 NO 6 NO 6 NO 2K 6...

Страница 190: ...70 55 Noise Reject 52 52 Noise Mode Standard Standard Time Point 0 32 0 32 Max time 360 360 Norms Off Off DP Stop Criteria Min DP Loops 2 2 Min Band Sig 5dB SPL 5dB SPL Min Band SNR 6 6 Pass Bands 70...

Страница 191: ...ax L2 70 L1 67 70 Step L2 5 L1 2 5 Noise Reject 52 52 Noise Mode Standard Standard Time Point 0 64s 0 64s Max time 360 360 DP Display Logic Min DP Loops 2 2 Min Band Sig 10dB SPL 10dB SPL Min Band SNR...

Страница 192: ...st Config Stim Type Chirp Chirp Stim Level 40dBHL 45dBHL Max NLo 10240 10240 Max time 600 sec 600 sec ABR Automation Autostart On On Autostop On Off ABR Stop Criteria Pass Criteria PC2 PC1 ABR Other S...

Страница 193: ...ting 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 Downlo...

Страница 194: ...When the connection to the PC is ready to send data the PC Load text on the Otoport screen is green If the connection is not complete then the PC Load text on the Otoport screen is black Bluetooth pri...

Страница 195: ...ct Print or PC Load for a printout or download of the patient details and test results 18 3 2 Printing or downloading from records Results can be printed or downloaded from the Otoport Records area Se...

Страница 196: ...details and then Print or PC Load 18 4 Transfer menu From the Otoport Transfer screen choose Select to open the Transfer menu where it is possible to initiate prints or downloads for the Last Test or...

Страница 197: ...to the mini printer Wireless printing and download are only available on Bluetooth enabled Otoports You can tell if a Bluetooth module is fitted as a Bluetooth symbol shown above is included on the p...

Страница 198: ...ing Station as it allows results to be printed as soon as the Otoport is dropped into the docking station On connect may be turned Off or set to print the last Test all unprinted tests for the last Pa...

Страница 199: ...ill be shown in green if the Otoport is currently connected to a printer wirelessly Otherwise the Print option is shown in black Note When using multiple Otoports with wireless connection to a single...

Страница 200: ...he printout is completed the screen from which the print was initiated will be displayed If there is a problem connecting to the printer using the wired method the message Check Connection will be sho...

Страница 201: ...ilable printers taking up to 30 seconds Up to five available printers will now be listed in order of signal strength The first number displayed on the screen corresponds with the serial number printed...

Страница 202: ...re spool the print job and flash the green light during this process When the printer problem has been rectified the printout should complete automatically If the printout does not complete automatica...

Страница 203: ...ng on battery power Flashing green The printer is storing print information spooling that cannot be printed at the time e g no paper or printer lid open Flashing green orange Battery is being charged...

Страница 204: ...r 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 using the paper feed f...

Страница 205: ...Charger jack plug socket The printer can be used as normal whilst charging Once fully charged the printer has enough power for around 10 hours standby use The batteries should provide enough power to...

Страница 206: ...To change the battery pack Remove the screw 1 from the battery compartment cover Push down and slide back the battery compartment cover 2 Remove the old battery pack and disconnect the battery pack c...

Страница 207: ...d which the Otoport will scan and verify in order to provide access to the machine 19 2 Scanner types The Otoport has two scanning methods available 19 2 1 Barcode scanning This method will scan barco...

Страница 208: ...g This method 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 t...

Страница 209: ...3 2 At login In order for a user to login using the scanning method it is necessary to set up their login account in the Management area see chapter 16 Management for more details On the New user scre...

Страница 210: ...ER NINETEEN Scanning 210 To login using a scanner select Scan on the login screen The Otoport will automatically login the user with their appropriate access rights and present the Test main menu Scan...

Страница 211: ...tion performance of a probe QA test history Select QA Test History to review previously performed system checks QA tests Select QA Tests to conduct system checks to ensure the device is functioning co...

Страница 212: ...eline reference On selecting Probe Test the message Place Probe into Otodynamics Test Cavity Press OK to begin test will appear on screen Remove the tip from the probe and place the cavity on a flat s...

Страница 213: ...nse of the probe has changed 20 2 1 Results The possible results of the test are Pass The levels recorded at all frequencies are within the absolute range and within 3dB of the probe specific values F...

Страница 214: ...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 invalidate testing It ma...

Страница 215: ...show which probe result is displayed Detail The full test result can be viewed by selecting Detail The details screen shows the levels recorded from the probe loud speaker at each frequency tested The...

Страница 216: ...rd the values for each frequency and repeat by selecting Retest Check that the values from two sequential tests are within 0 5dB before selecting Save Save is only available to admin users It is not a...

Страница 217: ...electrode cables are OK then a large tick is displayed on the screen If any of the cables fails the test a large cross is displayed Select Details to see the results for each cable The impedances sho...

Страница 218: ...DP QA tests are used if DP data is to be recorded OAE Cavity test Select OAE Cavity Test to run a test in the test cavity Occlusion test Select Occlusion Test to check for sound leakage within the pro...

Страница 219: ...d Checkfit screen and begin the Cavity Test or Cancel to return to the QA Tests Menu screen Follow the Checkfit and Test screen sequences until the test stops In a cavity the testing stimulus level sh...

Страница 220: ...ce is firmly inserted into the test cavity and that the noise conditions within the room are acceptable for a test to be conducted Continue to retest until the result Cavity OK is given If Artefact is...

Страница 221: ...is allocated a unique date time stamp Patient Details Field Cavity Test Default ID QA1 Name QA First Cavity Each test can be reviewed individually in the QA Occlusion Test History area Note If an art...

Страница 222: ...Block Coupler Tube ends with Finger Press OK to begin test will appear on screen To occlude the probe place a finger firmly over the end of the coupler tubes which will stop sound from being emitted...

Страница 223: ...occluded by a finger and that the noise conditions within the room are low Continue to retest until the Occlusion OK result is given If Artefact is shown at the end of the test save and retest making...

Страница 224: ...nd the test is allocated a unique date time stamp Patient Details Field Occlusion Test Default ID QA2 Name QA First Occlusion Each test can be reviewed individually in the QA Occlusion Test History ar...

Страница 225: ...essage Place Probe into an appropriate Ear Press OK to begin test will appear on screen The Real Ear Test utilises the identical test sequence as a standard test The test will not autostop if an OAE i...

Страница 226: ...l be consistently used for the tests so that changes in response can be easily seen which may indicate a change in the Otoport performance If a Real Ear OK result cannot be achieved in an ear which is...

Страница 227: ...ow 0 kOhms Follow the Checkfit and Test screen sequences until the test stops Please refer to the ABR Test chapter for a detailed description of how to perform a standard test Data collected during th...

Страница 228: ...th the probe the test cavity or with the Otoport Electromagnetic interference is an invisible source of noise so if there are persistent problems and other hardware issues have been eliminated try to...

Страница 229: ...identification for details 21 2 Probe cable clip The probe cable clip is provided to aid the practical aspects of positioning and securing the probe cable during OAE testing Using the probe cable cli...

Страница 230: ...he plunger The position of the clip on the cable can be adjusted if necessary Open the crocodile clothing clip Attach the probe cable clip to the patient s clothing If the cable slips through the grip...

Страница 231: ...ts 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 Extra large adult ears T8M REF T T8M Fits 8mm ear canal Infants and small adul...

Страница 232: ...B 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 Most adult ears R11M REF T R11M...

Страница 233: ...aves 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 with the patient OAEs should NOT be conducted if there is evidence of fl...

Страница 234: ...casing may be cleaned using alcohol based 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...

Страница 235: ...fig 1 Fit the outer shell figs 2 and 3 followed by the lid fig 4 Click the lid into place using firm finger pressure only Finally fit a new tip fig 4 Illustrations show TPC TEOAE coupler tubes 22 2 3...

Страница 236: ...s 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 incorrect or non Otodyna...

Страница 237: ...e patient being tested Otodynamics probe tips are disposable and for single use only A new tip should be used for each ear tested The tip protrudes 0 5mm beyond the end of the probe coupler to prevent...

Страница 238: ...port with an alcohol based sterile wipe or cloth and antiseptic fluid Dry the Otoport with tissue immediately afterwards Do not allow liquid to enter the instrument and do not immerse in fluid Do not...

Страница 239: ...save functions and by switching the device off for the periods between tests the battery will provide enough power for over a week of intense use 24 2 Initial charge The Otoport is fully charged befor...

Страница 240: ...in every minute to alert the user To resume from standby press any key on the keypad The Otoport will wake up and return to the previous screen displayed If the Otoport is left for 20 minutes in stan...

Страница 241: ...level of battery charge The indicator has 7 segments which convey the total Battery Charge remaining The battery segments are shaded according to the following criteria Segments Displayed Battery Powe...

Страница 242: ...y 24 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 OK to accept the me...

Страница 243: ...or use If the Docking Station is not used observe the on screen battery indicators to determine when to charge your Otoport There are two alternative ways in which the Otoport may be charged By connec...

Страница 244: ...Otoport Ensure the arrows are facing upwards Note If forced it is possible to insert the charger connector into the Otoport the wrong way up In this position the Otoport will not charge Press in the r...

Страница 245: ...s possible to leave the charger connected to the Otoport for extended periods even if the device is fully charged This may be convenient if you wish to leave the device charging overnight When powered...

Страница 246: ...ease keys squeeze to disconnect otherwise just pull out the cable The power light will extinguish on the Otoport and if the Otoport was off prior to the charging session the screen will return to blan...

Страница 247: ...screen The device will automatically be set to full power to drain the battery This process can take up to 6 hours The conditioning process may be stopped during this period by selecting Cancel The O...

Страница 248: ...e hold down the On off power key for 10 seconds this will force the unit to switch off Turn on the Otoport again 25 2 Switch on During switch on the Otoport conducts a series of system checks If the O...

Страница 249: ...bers reported and when the error occurred For support regarding a fault report error numbers to your dealer or Otodynamics Select Reset to reset the Otoport to factory default settings Changes from th...

Страница 250: ...n off the device and then switch it on again Important note The Instrument Fault message can be triggered by a partially connected probe Ensure that the probe is fully connected and the knurled sleeve...

Страница 251: ...layed The number displayed indicates the type of error detected You should make a note of this error number The Otoport should then be turned on and off a number of times to ensure that the error does...

Страница 252: ...ing 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 previous...

Страница 253: ...particularly the OAE instrument and probe are clean and free from contamination Otodynamics cannot guarantee the equipment will be contamination free when returned to you and suggest that it is clean...

Страница 254: ...ction 20 2 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 regular cali...

Страница 255: ...resentation pattern A A A B A A A B Where B 3A Noise rejection calculation The noise level for noise reject is calculated from the difference between consecutive sweeps Averaging The responses from ea...

Страница 256: ...econd Response window 3 13ms or 3 9ms after start of stimulus presentation Cosine filtered with rise and fall time of 2ms Response frequency bands Half octave centred at 1 1 4 2 2 8 4 and 5 6kHz Respo...

Страница 257: ...ve points below the DP frequency In the Rapid noise mode the mean of these points gives the noise level Medium uses the mean plus one standard deviation and Standard uses the mean of these points plus...

Страница 258: ...mplifier 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 signal 400 Hz squa...

Страница 259: ...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 give the required duration and a frequency range of 1686 to 4614Hz 3dB points The...

Страница 260: ...an 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...

Страница 261: ...nals i e from sleeping to restless is processed by the device As no acoustic stimulation actually reached the ear no real ABR was present so all passes are false Pass Criteria PC1 PC2 PC3 PC4 Tests 32...

Страница 262: ...f 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 the probability of...

Страница 263: ...slightly decrease specificity because click stimuli generate a slightly smaller ABR response than a chirp of identical hearing level due to reduced synchronisation The typical ABR amplitude reduction...

Страница 264: ...vel of confidence Once the level of confidence and number of frequencies is decided the necessary SNR can be computed By running many repeat cavity tests the occurrence rates of different SNR levels i...

Страница 265: ...ing is independent of other test points the probability of a given number of passes amongst a number of tests points can be derived In addition to the selected Noise Mode and the SNR the number of pas...

Страница 266: ...nfidence 2 of 6 3 of 6 4 of 6 5 of 6 6 of 6 99 8dB 6dB 4dB 3dB 1dB 99 9 10dB 8dB 6dB 4dB 2dB 99 99 12dB 9dB 7dB 5dB 4dB Standard mean 2 Std based SNR values for six test points e g 1 6kHz or 1 5 8kHz...

Страница 267: ...ultiband tables found in section 29 2 2 below 30 2 1 Confidence for a single octave band Minimum SNR required for confidence Average of level in a single band all bands Confidence 1kHz 1 5kHz 2kHz 3kH...

Страница 268: ...ce for single band pass mode A separate screening mode can be selected on the Otoport where the pass criteria is judged by the signal and noise across all frequencies The default settings for this mod...

Страница 269: ...e Value NPV The false pass rate for a test depends on both the confidence in the results of an individual test and the incidence of the disorder tested for The incidence of permanent hearing loss 40 d...

Страница 270: ...e 0 3 incidence a screening protocol of 2 bands from 4 with a minimum 5dB SNR stipulation we could predict that the screening process would miss one baby with a detectable hearing impairment every 5 y...

Страница 271: ...todynamics PSU charging or to PC USB port USB 1 1or 2 0 via Data Cable Bluetooth wireless print option RFID reader option 31 1 3 Indicators Data Display Resolution QVGA 320 x 240 pixels 166 dpi Techno...

Страница 272: ...ge 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 capacity Approximately 4 hours to 1...

Страница 273: ...o 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 operat...

Страница 274: ...stems 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 electrical equipment Part 1 Genera...

Страница 275: ...sure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group 1 The Otoport uses RF energy only for CISPR 11 its internal function There...

Страница 276: ...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 power quality should sho...

Страница 277: ...sential performance and were tested for immunity in compliance with IEC60601 1 2 a The collection of Otoacoustic Emissions OAEs b The retention of user settings and test results Technical specificatio...

Страница 278: ...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 vicinity of equipment marked wi...

Страница 279: ...ximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output p...

Страница 280: ...Harmonic emissions Class A purposes IEC 61000 3 2 Voltage fluctuations Complies flicker emissions IEC 61000 3 3 31 3 Electromagnetic Compatibility Otoport OAE ABR The Otoport OAE ABR should be put in...

Страница 281: ...f 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 power quality should short interrup 95 dip in UT 95 dip in UT be that of...

Страница 282: ...lowing functions of the Otoport OAE ABR are deemed essential performance and were tested for immunity in compliance with IEC60601 1 2 a The collection of Otoacoustic Emissions OAEs b The retention of...

Страница 283: ...romagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol The conducted and radia...

Страница 284: ...ast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the m...

Страница 285: ...GHz d 3 5 P d 3 5 P d 7 P 0 01 0 35 0 35 0 7 0 1 1 1 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...

Страница 286: ...ar 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 IEC 60711 Bruel and Kjear type...

Страница 287: ...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 stimulus varies between positive and negative according to the TEOAE test s...

Страница 288: ...ics 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 vi...

Страница 289: ...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 ind...

Страница 290: ...ifications 290 Refer to operating instructions Otodynamics factory address Product catalogue number Product date of manufacture Product serial number RF transmitter Training required SN REF TRAINING R...

Страница 291: ...Auditory Brainstem Response 20 21 Automation 174 Auto stop 175 176 Auto Stop 178 Auto switch off 242 B Backlight 51 140 142 Barcode RFID scanner 30 Barcode scanning 207 Battery 57 143 Beginning a test...

Страница 292: ...Downloading 193 DP Growth 18 19 104 106 131 164 170 DP level 17 DP Noise rejection calculation 257 DPOAE probe tips 232 DPOAE recording 96 DPOAE test 89 DP Thresh 104 DP Zoom 90 170 E Ear canal size i...

Страница 293: ...rge 239 Instrument fault message 250 Interfaces 271 I O testing 18 K Keypad 48 271 L Line fit criteria 105 Location 75 147 Lock 184 Login 58 150 Logo 57 Loops 184 Low battery 242 M Management 145 Mand...

Страница 294: ...1 Probe socket 29 Probes safety 236 Probe test 212 Probe tips 231 232 Q QA test menu 218 Quickstart 42 R Real ear test 225 Records 126 Regulatory marks 32 35 Removing the Otocheck from the ABR Module...

Страница 295: ...nformation 79 94 97 Test config 158 159 162 166 Test frequency loop 97 Test main menu 59 Test result 88 103 Test results 88 103 118 Test review 123 133 Test review screens 123 Test sensitivity 17 Test...

Страница 296: ...CHAPTER THIRTY TWO Index 296...

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