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Otodynamics DP Clinical User Manual Download Page 24

CHAPTER TWO

Equipment identification

24

Equipment identification

2.6

  OAE labelling

2.6.1

 

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 applied part 

 

 

 

 

  

  

Bluetooth® enabled

 

  

 

Otoport Product Label – International

(OLABL-0083-IEC)

100173-IEC

JB

DWG No:

SCALE:

DIMENSIONS:

DRAWN:

CHECKED:

APPROVED:

TITLE:

30-38 Beaconsfield Rd, Hatfield, Hertfordshire, AL10 8BB

ISS.

DATE

D.C.N.

CHECKED

UNLESS OTHERWISE STATED ASSUME:
ANGULAR TOLERANCE:

± ½°

WHOLE UNITS:

±0.5mm

1 DECIMAL PLACES:

±0.3mm

2 DECIMAL PLACES:

±0.1mm

GEOMETRIC TOLERANCES SEE BS308 METRIC

DETAILS ON THIS DRAWING ARE 

COPYRIGHTED AND MUST NOT BE 

REPRODUCED WITHOUT THE PRIOR 

CONSENT OF OTODYNAMICS LTD.

JM

JM

1        20-03-14                                   JM  

Label Information

Size: 

49mm x 29mm, corner radius 2.5mm

Material:

 Matt Silver Polyester

Adhesive:

 Permanent

Printer:

 thermal transfer, 300dpi

Ribbon:

 ARMOR AXR®8, black

Printed label shall meet the durability requirements of :

IEC 60601-1

2        04-02-15                                   JM  

Symbols Key

DC

Caution

    

Class II electrical protection (double insulated)

          

Type BF applied part

          

Refer to operating instructions

     

Manufacturer

 

           Bluetooth module fitted

C

    

CE mark with Notified Body number (SGS)

     Serial Number

     

WEEE Directive applies

Arial Black 9pt

Arial 7pt

Unique Device Identifier (UDI)

GS1 barcode – application identifiers:

(01)  Global Trade Item Number (GTIN)

        (different GTIN for each Otoport variant)

(11)  Production Date

(21)  Serial Number

(240)  Additional Product Identification (optional modules fitted)

(250)  Secondary Serial Number (GSN)

Barcode format:

Datamatrix: Xdim = 0.34mm, ECC 200,

Text encode = US/Western Europe (ISO 8859-1)

Arial Bold 

4.5pt

90% width

Arial Bold 4pt

90% width

Arial Bold 4pt

90% width

Arial Narrow Bold 6pt 80% width

Variable field - product (firmware) variant

Arial Bold 6pt

80% width

Variable field – Serial No.

Variable field – UDI

Arial Bold 3pt

3        07-05-15                                   JM  

n/a

4        21-11-16                                   JM  

Not to scale

Summary of Contents for DP Clinical

Page 1: ...Otoport OAE ABR User Manual for Otoport DP TE models Including DP Clinical DP Clinical Flexi DP TE and Otoport Flexi Otoport OAE ABR Otoport DP TE models Issue 5...

Page 2: ...permission of Otodynamics Ltd Copyright 2017 Otodynamics Ltd All Rights Reserved Otodynamics Ltd 30 38 Beaconsfield Rd Hatfield Herts AL10 8BB UK 0120 User Manual for Otoport OAE ABR Otoport DP TE mo...

Page 3: ...17 2 3 Supplied in both kits 18 2 4 Optional accessories 21 2 5 Controls indicators and connections 23 2 6 OAE labelling 24 2 7 Otoport OAE ABR controls indicators and connections 26 2 8 ABR labellin...

Page 4: ...ctrode fitting 55 6 Test troubleshooting 58 6 1 OAE test problems 58 6 2 ABR test problems 59 7 Test selection 61 7 1 Choose test type or worklist 61 7 2 Patient details 63 7 3 Select test ear 64 7 4...

Page 5: ...details 101 11 3 Review 102 11 4 Last 103 11 5 Result 105 12 Link Test 106 13 Work List 107 13 1 Adding Patients 107 13 2 Editing details 108 13 3 Deleting Patients 109 13 4 Testing from the Work List...

Page 6: ...er 157 16 9 Changing the battery 158 17 Quality tests 159 17 1 Probe test 159 17 2 ABR cable test 165 17 3 Cavity test 166 17 4 Occlusion test 167 17 5 Real ear test 168 18 Probe tips and accessories...

Page 7: ...87 22 2 Switch on 187 22 3 System details 187 22 4 Instrument fault message 188 22 5 Hardware fault messages 189 23 Training 190 24 Obtaining service 191 25 Calibration 192 26 Mode of operation 193 26...

Page 8: ...8...

Page 9: ...fer result is presented to the user who will be a trained screener audiologist or medical professional Use of the device is indicated when the patient is unable to give reliable voluntary responses to...

Page 10: ...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 interference with ABR...

Page 11: ...inue indefinitely even if there is no result The Otoport includes stop criteria which will automatically terminate the test when an OAE or ABR pass has been achieved or within ten minutes Whilst this...

Page 12: ...may apply a louder than normal sound to the ear Before inserting the probe the ear should be inspected to ensure that the ear canal is clean If this precaution is not taken the probe may be damaged T...

Page 13: ...generated by 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 Th...

Page 14: ...n 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 The specific ri...

Page 15: ...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 A...

Page 16: ...ion 2 Equipment identification 2 1 Supplied only in Otoport OAE ABR kit REF DTC ABR Otoport DP TE OAE ABR REF ABR EC1 Electrode cables 1m REF ABR EC2 Electrode cables 2m REF ABR SK Starter kit of elec...

Page 17: ...ABR INF Infection 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 DP TE kit REF DTC S Otoport DP TE REF OP CAS...

Page 18: ...R TWO Equipment identification 18 Equipment identification REF PR CLIP Probe cable clip REF PR POUCH Drawstring probe pouch REF PR UGD UGD DPOAE probe 2 3 Supplied in both kits REF OAE CAV Probe test...

Page 19: ...ion REF DPC DPC probe coupler tubes x 5 Re order quantity 10 or 100 REF BGD BGD probe body and lid x 1 Re order quantity 10 REF DP BOX Sample probe tips See chapter 18 Probe tips and accessories for r...

Page 20: ...ification 20 Equipment identification REF OTOLINK Otolink software CD REF OP INF Infection control sleeve for Otoport only Shown fitted Documentation pack Includes instrument and software manuals quic...

Page 21: ...ng and downloading to PC REF OMP R Otoport printer Wired and wireless models available for Otoport DP TE Wireless model available for Otoport OAE ABR REF OPP CAS Large equipment case For use with Otop...

Page 22: ...r 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 printe...

Page 23: ...ification 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 status indicators Speaker Charger and PC...

Page 24: ...ERANCES SEE BS308 METRIC DETAILS ON THIS DRAWING ARE COPYRIGHTED AND MUST NOT BE REPRODUCED WITHOUT THE PRIOR CONSENT OF OTODYNAMICS LTD 1 20 03 14 JM Label Info Size 49mm x Material Ma Adhesive Pe Pr...

Page 25: ...code DTC in this instance year and month of manufacture yymm and unique manufacture ID xxxx The complete serial number is therefore DTC yymmxxxx 0120 2 6 2 Certification or regulatory marks The label...

Page 26: ...n 2 7 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...

Page 27: ...7pt Symbols Key DC Caution Class II elec Type BF app Refer to ope Manufacture Serial Numb C CE mark wit WEEE Direc DWG No SCALE TITLE 30 38 Beaconsfield Rd Hatfield Hertfordshire AL10 8BB ISS DATE D...

Page 28: ...eference Otoport DP TE 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 module...

Page 29: ...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...

Page 30: ...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...

Page 31: ...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...

Page 32: ...he ABR sleeve up and and tilt it back 3 2 3 Move the Otoport up to disconnect it from the port at the bottom of the sleeve and remove it from the Module Do NOT tilt the Otoport forward while lifting i...

Page 33: ...nd electrodes is found at the top end of the module 3 4 1 Connecting the probe Follow instructions for connecting the probe to the Otoport in section 3 7 If you are using two probes ensure that the pr...

Page 34: ...tud connectors for electrode attachment Alternatively any wired electrodes that are terminated with 1 5mm Touchproof DIN 42 802 connectors may be used Carefully align the electrode connector plug with...

Page 35: ...3 5 Initial charge Before using your Otoport for the first time fully charge the unit See chapter 21 Otoport Power for details 3 6 Quickstart guides Quickstart guides for OAE and ABR tests included as...

Page 36: ...2 Fit the DP tip to the earpiece 3 Fit the earpiece in the ear canal 1 With the arrow at the front connect the DP grey probe and screw the knurled sleeve until finger tight 2 Press the button to turn...

Page 37: ...AVE the test E Disconnecting the probe Step 4 Disconnecting the probe P O 3 Gently pull out the probe 1 Unscrew the knurled sleeve 2 Do NOT turn the main probe body 9 Press to Retest the same patient...

Page 38: ...ate sized tip to the probe and insert the probe in the ear to be tested Ensure electrodes are attached correctly 1 Prepare and clean the skin at the electrode sites to ensure low impedances Apply elec...

Page 39: ...ed on the screens Their functions vary from screen to screen but generally the right circle key provides affirmative options and the left square key provides negative options 3 7 2 Arrow navigation bu...

Page 40: ...ed 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 displayed...

Page 41: ...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 yyy by default For Date of Birth entry D O B the Otoport will not permit entry o...

Page 42: ...ays on for 7 seconds default following any key press and remains on during testing This setting can be changed in the Configuration area see chapter 15 3 7 9 Stimulus and Noise OK indicators blue LEDs...

Page 43: ...tains a key that must be aligned with the keyway in the probe socket on the Otoport Socket keyway Probe key The arrow at the front of the probe plug indicates the position of the key and should be ali...

Page 44: ...end stop DO NOT force in the probe Screw up the knurled sleeve in a clockwise direction until finger tight 3 9 Disconnecting the probe To disconnect the probe unscrew the knurled sleeve in an anticlo...

Page 45: ...hen gently pull the probe out from the probe socket Main probe body Important Note Do NOT attempt to screw or unscrew the probe by holding the main probe body smooth chrome section Remove probe This w...

Page 46: ...f the keypad The display screen will show Switch Unit On Select Yes to confirm Otoport switch on or No to turn the unit off again If Yes or No are not selected within two seconds of pressing on off po...

Page 47: ...n the unlikely event of any of the systems checks failing an error message will be displayed see section 22 5 Hardware fault messages for details A battery graphic will appear to the right of the logo...

Page 48: ...e is present The Clinical mode is designed to run longer more detailed tests that will run until the user is satisfied with the quality of the data Select the mode which meets your requirements Both m...

Page 49: ...e the user is selected use the data entry keypad to enter a corresponding Password if set for that user To improve security during Login a symbol will replace each character as it is entered in the Pa...

Page 50: ...r after successful login the test screen for the last test used is displayed From here you can view the Result for the last patient tested edit the details for the Last patient tested or start a Test...

Page 51: ...ort OAE ABR User Manual for Otoport DP TE model 51 Switching on See chapter 7 Test selection for further information on choosing a test OAE ABR model ABRcustom only available if configured see chapter...

Page 52: ...y discharge 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...

Page 53: ...its size and to check that 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 wi...

Page 54: ...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...

Page 55: ...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...

Page 56: ...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...

Page 57: ...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...

Page 58: ...ng session usually brings success when the ear has had time to clear Babies are best tested when they are sleeping or sleepy and successful OAE recordings are most often made one hour after a feed The...

Page 59: ...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...

Page 60: ...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...

Page 61: ...selection 7 1 Choose test type or worklist Using the left and right arrow keys choose one of the test types The available modes will depend on whether Screen or Clinical test mode was selected TRAINI...

Page 62: ...P 12 Freq tests from 1 8kHz at quarter octave points Note Configure the modes available in the Config area see chapter 15 Configuration Modes turned Off here will not be available The banner at the to...

Page 63: ...three fields are available by scrolling down using the arrow keys These are NICU Yes or No Location Inpatient Outpatient or At Home and Facility Note It is only possible to store one Facility on the O...

Page 64: ...the left arrow key to select the Right Ear ABR tests may be run bilaterally on both ears so a third option Both can be chosen Further information on bilateral ABR testing follows in chapter 10 If the...

Page 65: ...Size Indicator this shows a series of ears of increasing size indicating increasing ear canal volumes The size of ear canal detected in Checkfit is indicated by an arrow During Checkfit the Otoport r...

Page 66: ...e 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 green if it is be...

Page 67: ...re than one condition is met Note that highlighted messages also appear during the test Consistent Stimulus Out Stimulus Highlighted High Noise of Range Ringing Message No No No Checkfit Yes No No Noi...

Page 68: ...d not a TE UGS red probe If calibration continues to fail regardless of the position of the probe in the ear it is likely that the probe has become blocked In this case inspect the probe coupler tubes...

Page 69: ...The initial test screen displayed depends upon the display option set from the Configuration menu see chapter 15 Configuration Switch between the test screens by pressing the left or right arrow keys...

Page 70: ...rms are for indication only and do not affect stop criteria The F2 frequencies are displayed below the bars dots The blue section of each band represents the DP signal level at the 2F2 F1 frequency an...

Page 71: ...en the test has stopped a tick check mark is shown in the circles that passed The Circles display is not available in DP 12 Freq mode 8 2 3 Infant distraction screens These screens are designed to enc...

Page 72: ...the test points the test duration and the test mode used 8 2 5 Noise level indicator A noise level indicator is shown on the right of screen The bar moves in response to changes in noise For good test...

Page 73: ...es as listed in table below and with stimulus levels above 65dBSPL the minimum recordable signal level increases and so a larger signal is required for a DPOAE to be recorded If the signal level is be...

Page 74: ...and Yes to end the test 8 3 1 Test timeout If a test has not met the set pass criteria and the noise is consistently above the Noise Reject Threshold Level so that the Maximum NLo Sweeps cannot be ac...

Page 75: ...ation feedback to the user No Valid OAE The 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...

Page 76: ...has the option to Continue or Cancel the test In these circumstances Otodynamics recommends that the test is cancelled Efforts should then be made to improve the probe fit check the probe coupler tub...

Page 77: ...f 6dB and a minimum signal of 5dBSPL in at least two frequency bands It is the responsibility of the user to ensure that the pass criteria set meet their requirements The test screen display depends u...

Page 78: ...es Each small circle represents the SNR recorded in a particular octave frequency band when the minimum signal level is met If the minimum signal level is not met the circle will not fill completely e...

Page 79: ...A is shown in orange and waveform B in yellow Waveforms that correlate well represent good quality recordings with low noise Significantly different waveforms indicate a noisy recording As the test co...

Page 80: ...uring the test by pressing right or left arrow keys 9 2 6 Noise level indicator A Noise Level Indicator is shown on the right of the Checkfit screen The bar moves in response to changes in noise For g...

Page 81: ...beep twice if the test has stopped with any other result 9 3 1 AutoStop If the test data collected meets the set pass criteria then the test will AutoStop and a large checkmark will be displayed 9 3 2...

Page 82: ...to pause a test for instance during periods of noise When the test is paused it is possible to cancel the test and discard the data Select Cancel to pause the test Select Yes to end the test and disca...

Page 83: ...ted is three times greater than the low noise data collected Poor Probe Fit Probe movement has been detected Too Few Bands Insufficient bands meet their pass criteria Stopped Too The test was ended ma...

Page 84: ...de 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 w...

Page 85: ...r poor If 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 go...

Page 86: ...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 Try to resolve t...

Page 87: ...ate More 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 imp...

Page 88: ...es 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 acceptable but the PN...

Page 89: ...section 7 2 for details Checkfit with ear cups is described below 10 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 o...

Page 90: ...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 10 4 ABR test During the test the...

Page 91: ...NSE is an 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 nois...

Page 92: ...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 10 4 2 Waveform dis...

Page 93: ...e levels are within range again The Otoport will beep to warn the user if test conditions of either Check Probe Fit or Noisy conditions are present for too long If the Check probe fit message is shown...

Page 94: ...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 collected meets th...

Page 95: ...e will stop the test 10 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 wo...

Page 96: ...tained 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 interference and the Fsp d...

Page 97: ...R tests automatically run tests on both ears in sequence right ear then left ear Ear cups are recommended for bilateral testing and both ears should be prepared before testing commences The current te...

Page 98: ...ear starts When both tests are complete stop reason icons for both ears will be shown on the screen together It is not possible to review bilateral ABR tests in detail at the end of test If you wish t...

Page 99: ...Save Off If Quick Save is Off select Save to Save the test result Select Cancel to discard the test result A prompt requiring confirmation will be shown before the result is discarded Select Review to...

Page 100: ...scarded Select Retest to save the result and run another test on the same patient This will navigate back to the ear selection screen to select the test ear for the next test Select Finish to return t...

Page 101: ...npatient Outpatient or At Home and Facility Note It is only possible to store one Facility on the Otoport and it should not be changed for individual patients If you wish to change the Facility downlo...

Page 102: ...sults to Retest the same patient or to Finish and return to the main menu Retest will start a new test of the same type for the patient This can be used to retest the same ear or to test the opposite...

Page 103: ...tient record by selecting Last from the main menu Patient details can be amended and tests printed using this function From the Main Menu select Last The Patient Details screen is displayed Select Tes...

Page 104: ...and then entering the new data using the keypad All fields except Location Facility and NICU can be edited When an edit has been made the screen will change If you are happy with the changes you have...

Page 105: ...r Manual for Otoport DP TE model 105 Saving the test 11 5 Result Select Result to review the tests results for the current patient Select displays the detailed result for this test Select Print to pri...

Page 106: ...e Select Link Test from the scrolling modules Enter Patient Details and select the test ear Test ear is selected before the test begins rather than after as for other test modes so that tests may then...

Page 107: ...e testing To use the Work List it must be turned on in the Config area see chapter 15 Access the Work List by using the left or right navigation keys from the main menu If there are patients in the Wo...

Page 108: ...over written When details are complete select Save to save the details to the Work List Test to run a test on this patient immediately or Back to discard these patient details Up to 50 patients may b...

Page 109: ...the patients from the Work List Select No to return to the Work List without deleting any patient details 13 4 Testing from the Work List Scroll to the required patient and select Test Use the left an...

Page 110: ...ly tested Record also allows the user to select a previously tested patient for a new test Records may only be deleted from within the Configuration area via the System menu from the Memory Status scr...

Page 111: ...that the highlighted patient is 226th in a list of 234 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 i...

Page 112: ...lecting 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 arrows on the patient details screen displays the p...

Page 113: ...right of the screen The up and down arrow indicators to the left of the screen show that there are other saved test records for this patient The left and right arrow indicators display the details fo...

Page 114: ...Tested R Right or L Left Total Noise response Date of Test Time of Test User ID Total OAE signal response Test type Stimulus level Pass criteria DPOAE test summary screen Patient s Name No of Test sa...

Page 115: ...left and right arrow keys to scroll between the screen choices Select Back at any time to exit and return to the test summary Select Print to print results see chapter 16 Printing TRAINING REQUIRED P...

Page 116: ...est Settings to change test display and pass criteria Select Date Time to set the current date and time Select System for memory battery and system information Select Users for login options Note User...

Page 117: ...n a mode off use the up or down arrow keys to select Screen or Clinical then the left or right keys to display Off Select Edit to change the settings for either mode Select Save to keep your changes o...

Page 118: ...changes made to settings and return to the Configuration screen Display If dBSPL is selected a bar chart showing signal and noise at each frequency is displayed during testing If Circles is selected e...

Page 119: ...est screen Ear canal cavities greater than around 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 threshol...

Page 120: ...atio SNR in this mode indicates that a high accuracy of measurement has been reached The Rapid mode is appropriate for secure detection of the presence of OAEs at a set number of frequencies for scree...

Page 121: ...gion is 60Hz 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 se...

Page 122: ...atio SNR of 6dB over the 841 4757Hz frequency range in order to meet the pass criteria However this setting uses a filter of 1 6 3 2kHz and a stimulus response window 4 10ms to reduce the impact of en...

Page 123: ...meters Min sweeps NLo 30 Min total wide band OAE signal 0dBSPL Min band signal 5dBSPL Stimulus level 84 1dB pe Max test time 300 seconds Max low noise NLo 260 sweeps of 16 stimulus presentations sweep...

Page 124: ...th the Start setting Off the user must initiate the test by selecting Start when the probe fit and test conditions are satisfactory Irrespective of the Start setting the Start button is available in o...

Page 125: ...Levels Configuring Levels sets two DP stimulus pairs L1 and L2 which are available for selection prior to test Stimuli in DP High must be of a higher intensity than those set in DP Low Note It is not...

Page 126: ...a of Any 5 Bands as it will not be possible for the test to meet the pass criteria DP 12 Freq mode can be set at Any 2 to Any 12 Bands Fixed test parameters Min band signal 5dBSPL Max test time Approx...

Page 127: ...w com 2013 10 an overview of oaes and normative data for dpoaes The default norm levels in the Otoport represent the range from the 10th to the 90th percentile of the test population aged 18 25 This m...

Page 128: ...Start With the Start setting Off the user must initiate the test by selecting Start when the probe fit and test conditions are satisfactory Irrespective of the Start setting the Start button is availa...

Page 129: ...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 b...

Page 130: ...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...

Page 131: ...measured If Stop is ON when screening the test will be as short as possible Stop is configurable only in ABRcustom default is ON in both modes Pass criteria Pass criteria sets the conditions in which...

Page 132: ...for performing an ABR test on adult subjects and is the default setting for ABRcustom mode It is useful for training demonstration and clinical investigations PC2 is designed for neonate screening an...

Page 133: ...On Noise Mode Rapid Standard TEOAE TE Quick 84 dBpe 84 dBpe Mode Narrow Any2Bands Norms Off Off Start On On Stop On Off DP High DP Levels Off 70 70 Mode Any3Bands Any3Bands Smart On On Norms Off Off F...

Page 134: ...els Off 65 55 Mode Any9Bands Any9Bands Smart On On Norms Off On Start On On Stop On Off Band SNR 6 6 ABR Screen Stim Level 40 dBHL Off Pass Criteria PC2 PC2 Ear Cups Auto Auto ABR Custom Stim Level Of...

Page 135: ...and down arrow keys Continue to use the left and right arrow keys to jump between the Day Month Year and the up and down arrow keys to select the required date The date Format can be changed between d...

Page 136: ...the user A screen confirming the Erase is then displayed and the user is returned to the main menu If there is less than 10 free memory then the Memory Status screen will be displayed at start up When...

Page 137: ...n the display by a number of shaded blocks Use the Left Right Arrow buttons to decrease or increase the Volume level To turn the sound off press the left arrow key repeatedly until Sound Off appears i...

Page 138: ...acklight Use the left and 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 specific...

Page 139: ...mode of operation The battery graphic on the right of the screen conveys the total remaining power The battery segments are shaded according to the following criteria Segments Displayed Battery Power...

Page 140: ...etooth Bluetooth sets how the Otoport s wireless communication will be used If Bluetooth is set to PC Load then the Otoport can use Bluetooth communication to send test results to a PC Details of how...

Page 141: ...end of the test Select Save to accept the setting and 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...

Page 142: ...st Patient or All unprinted tests Printing will only start if the Otoport is on and displaying one of the main module screens If Cancel is selected during the print three options are available If Canc...

Page 143: ...d mode of operation including the model variant name The firmware revision number and issue date are stated together with the unit s unique Hardware ID and machine ID GSN The next scheduled Calibratio...

Page 144: ...ed the test The User ID must therefore be unique and the message Cannot Save User ID already exists will appear on Save if the chosen User ID is already associated with a current user The device will...

Page 145: ...ave changes to the user s details and return to the user list Select Delete to remove the selected user from the user list A confirmation message will appear at the top of the screen Select Yes to con...

Page 146: ...ng 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 include...

Page 147: ...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 printing is described thro...

Page 148: ...ading 148 Printing 16 3 When you can print The Otoport provides flexible options to print from various areas of the user interface including printing at the end of the test Print settings are located...

Page 149: ...he current patient depending on the Otoport configuration see chapter 15 16 3 2 Printing or downloading from records Results can be printed or downloaded from the Otoport Records area Select the patie...

Page 150: ...the different tests for the patient using the up and down arrow keys and select Print or PC Load Select PC Load on the Utilities menu to download all new records for all patients and tests that haven...

Page 151: ...ype There are two printing formats provided on the Otoport Summary and Detailed The Summary format below left prints core patient details and the test results The Detailed format right prints all the...

Page 152: ...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 Print...

Page 153: ...nected 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 displayed providing options to cancel search for an...

Page 154: ...tore it with your patient records 16 5 Printer fault detection The printer can detect if the paper roll has run out or if the lid is open The Otoport will report the printer is out of paper and the fo...

Page 155: ...cate various conditions Constant green Normal operation running on battery power Flashing green The printer is storing print information spooling that cannot be printed at the time e g no paper or pri...

Page 156: ...small 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 us...

Page 157: ...also 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...

Page 158: ...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...

Page 159: ...initiated from within the Configuration menu the Cavity Occlusion and Real Ear tests involve running a standard TEOAE or DPOAE test 17 1 Probe test Probe Test is an option accessed from the configurat...

Page 160: ...test cavities Remove the tip from the probe and place the cavity on a flat surface Insert the probe into the test cavity at a 90 degree angle to the top of the cavity between the screws as shown below...

Page 161: ...arning if the response of the probe has changed 17 1 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 prob...

Page 162: ...electing 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 invalidat...

Page 163: ...ity checks Dual probe result If two probes are connected to the Otoport then both are tested and a test result for each is shown The full test result for either can be selected when Detail is selected...

Page 164: ...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 for each...

Page 165: ...ect ABR Cable Test and wait for the result to be displayed If the electrode cables are OK then a large tick is displayed on the screen If any of the cables fail the test a large cross is displayed Sel...

Page 166: ...in the room are acceptable for a test to be conducted Continue to retest until a No Valid OAE result is given At the end of the test 1 Use the arrow keys to view the data table and check that the nois...

Page 167: ...elps to check that the probe is assembled and is performing correctly To occlude the probe place a finger firmly over the end of the coupler tubes to block sound from being omitted from the ear piece...

Page 168: ...ring 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 Real Ear OK result in an ear which...

Page 169: ...pare probe body lid See chapter 2 Equipment identification for details 18 2 Probe cable clip The probe cable clip is provided to aid the practical aspects of positioning and securing the probe cable d...

Page 170: ...n 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 cabl...

Page 171: ...T R4 8S Fits 4 8mm ear canal Small newborns R5 8B REF T R5 8B Fits 5 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...

Page 172: ...ually examined for signs of contamination and the outer parts cleaned with an antiseptic wipe Take care not to squeeze any cleaning fluid into the tubes OAEs should NOT be conducted if there is eviden...

Page 173: ...Probe casing The probe 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 cou...

Page 174: ...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 pressure only Finally...

Page 175: ...use with an Otodynamics disposable tip Use of a tip is essential Use without a tip will expose the ear canal to the hard plastic sound tubes and this might cause injury Use without a tip or with an in...

Page 176: ...er than the probe ear piece and cable the Otoport hardware should not come into contact with the patient being tested Otodynamics probe tips are disposable and for single use only A new tip should be...

Page 177: ...is 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 liq...

Page 178: ...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 between tests the battery will prov...

Page 179: ...turn 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 alert the user pri...

Page 180: ...a battery indicator which displays the remaining level of battery charge The indicator has 5 segments which convey the total battery charge remaining The battery segments are shaded according to the f...

Page 181: ...o charge the battery 21 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...

Page 182: ...harge 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 2...

Page 183: ...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...

Page 184: ...e 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 i...

Page 185: ...m The condition utility is available from the Configuration menu by selecting System then Battery Selecting Condition and confirming will set the device to full power to drain the battery This process...

Page 186: ...s lead to the charger plug the mains lead into a power socket and switch on the power The green light on the charger will illuminate indicating it is powered Then connect the slotted charger plug to t...

Page 187: ...system checks If the Otoport will not switch on and complete its start up sequence check that it is charged and try again If the Otoport still fails to complete its start up sequence then contact you...

Page 188: ...llowing message will be displayed at the start a test Instrument fault turn off Otoport then run system checks No stimulus will be delivered from the Otoport DP TE probe and you will not be able to st...

Page 189: ...ould then be turned on and off a number of times to ensure that the error doesn t recur If you receive the hardware fault message again contact your distributor or Otodynamics for support Error 2 An E...

Page 190: ...only 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 b...

Page 191: ...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...

Page 192: ...hecks see chapter 17 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 re...

Page 193: ...r 80ms gives 2048 points FFT frequency bin 25Hz DP Noise calculation DP noise from the five spectral points above and the five points below the DP frequency In the Rapid noise mode the mean of these p...

Page 194: ...sweep presents 8 stimuli responses with the stimulus presentation 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 betw...

Page 195: ...ly 80 stims per second Response window 2 5 12 5 ms or 4 10 ms 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 4kH...

Page 196: ...lifier 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...

Page 197: ...ating 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 gi...

Page 198: ...iffering 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 instrume...

Page 199: ...ses 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...

Page 200: ...mulus 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 t...

Page 201: ...ss than 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 hearin...

Page 202: ...ctor compatible with Otodynamics UGx probes 8 pin Charging Data connector connects to Otodynamics PSU charging or to PC USB port USB 1 1or 2 0 via Data Cable Bluetooth wireless print option 27 1 3 Ind...

Page 203: ...8 Hardware processing and storage Embedded microcontroller plus dedicated hardware DSP engine 4GB of non volatile memory for storing programs configuration patient details and test results 27 1 9 Ana...

Page 204: ...ressure 23KPa to 101KPa Humidity 10 to 90 non condensing Warm up time 10s when unit is stored within stated temperature range Operating Indoor use Temperature range 5 to 40 Celsius Humidity Max 80 up...

Page 205: ...nts 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 elect...

Page 206: ...ectromagnetic environment specified below The user of the Otoport should ensure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions Group...

Page 207: ...kV 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 M...

Page 208: ...chnical 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 OA...

Page 209: ...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...

Page 210: ...0 12 0 23 0 1 0 38 0 38 0 73 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 estima...

Page 211: ...s buildings used for domestic Harmonic emissions Class A purposes IEC 61000 3 2 Voltage fluctuations Complies flicker emissions IEC 61000 3 3 27 3 Electromagnetic Compatibility Otoport OAE ABR The Oto...

Page 212: ...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 Main...

Page 213: ...hnical 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 Emiss...

Page 214: ...tres 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 vic...

Page 215: ...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...

Page 216: ...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 d in metres m can be esti...

Page 217: ...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...

Page 218: ...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...

Page 219: ...tors 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...

Page 220: ...Symbol explanations Class II Type BF Bluetooth enabled Caution USB 1 1 When discarded the item must be sent to separate collection facilities for recovery and recycling Probe socket Battery charging...

Page 221: ...rt DP TE model 221 Technical specifications Refer to operating instructions Otodynamics factory address Product catalogue number Product date of manufacture Product serial number RF transmitter Traini...

Page 222: ...CHAPTER TWENTY SEVEN Technical specifications 222 Technical specifications...

Page 223: ...74 81 Bilateral ABR testing 97 Blue LEDs 42 Bluetooth 140 146 Brightness 138 C Cable clip 169 Calendar 203 Calibration 192 Cancelling the test 74 82 Cavity test 166 Certification 25 28 Changing probe...

Page 224: ...Electrodes 33 55 Electrode sockets 26 Electrode test 165 End data 141 End print 141 Entering dates 40 41 Environmental 204 Environment checks 52 Error 2 189 F Fault message 188 FFT frequency bin 193 F...

Page 225: ...ck up 187 P Paper 156 Pass 161 Password 49 Patient details 101 Patient list 111 Pausing and cancelling the test 82 Poor probe fit 75 83 Power 203 Print 141 Printer battery 158 Printer fault detection...

Page 226: ...tion rate 195 Stop 124 Summary results 113 Switch on 46 Symbol explanations 220 Symbols 24 System 136 System details 187 System info 143 T TC 91 Template correlation 91 TEOAE probe tips 171 TEOAE sett...

Page 227: ...Otoport OAE ABR User Manual for Otoport DP TE model 227 Index...

Page 228: ...CHAPTER TWENTY EIGHT Index 228 Index...

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