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        Otoport Lite Manual Issue 3
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1.        e    A    s          10    CHAPTER ONE  Introduction    Visually inspect the coupler tubes before use  A blocked sound delivery  tube may prevent the Otoport from achieving its target stimulation level and  so prevent testing  It may also attenuate certain frequencies and limit the  number of pass bands  A blocked microphone tube will prevent the Otoport  from sensing the stimulus level in the ear and from detecting the OAE  As  a result the Otoport may apply a louder than normal sound to the ear     All surfaces of the Otoport may be cleaned with an alcohol based wipe or  cloth with antiseptic fluid  Dry the device immediately with tissue     Do not allow liquid to enter the instrument     If additional hygienic protection is required  clear plastic infection control  sleeves designed to contain the Otoport during use are available from  Otodynamics     2 1    2 1 a    2 1 6    2 1       22128    Otoport Lite   11  User Manual    Getting started    Otoport Lite case contents    Note   Otoport and accessories not  shown to scale       Take a few moments to familiarise yourself with your Otoport kit     Otoport Lite   handheld OAE instrument       Soft fabric drawstring probe bag        Q                7   3      Je     Q  9        12   CHAPTER TWO  Getting started    2 1 e    PAi    2 1 9    2 1 h    21i    Test cavity for probe checks       Probe accessories  see chapter 12 for further information      ie Probe cable clip    ee Sample probe coupler tubes    a  Spare 
2.       To print patient details and all test results for that patient  select Print on  the Patient Details screen     88   CHAPTER NINE  Printing    923c  Toprint patient details and the result of a specific test  select the Results  summary screen  scroll through the different tests for the patient  using the  up and down arrow keys  and select Print          TEQAE  Lf A TEOAE PASS      u Any2Bands  Bde    OAE 12 308  OOOO  Noise 3ga L  34  1 Jan 12 12 16 ADN    BACK PRINT       924     Sample prints    DAE Test result  ELT NNN  PATIENT DETAILS    ID Notes  PASS    Name  JA  0 0 8  11 Nou  2009  Gender  Female  Comments   Left Ear  TEDRE  9 8 dBSPL  ID Notes  PASS  Technical details  haB E cia  eh TORR E   rovocol  Wide and Left Ear  N Reject  Med Noisy  0   Sell 37  Sun S7 TRAS PHE  tabi 100  Repro  95  m  Duration 35   User AD Noise   3  0 Set    Detailed print Summary print    9 3    9 3 a    9 3 b    9 3 c    9 3     9 3 e    Otoport Lite   89  User Manual    The printing process    If you are using the wired printing method ensure the printer is connected  to the Otoport using the printing cable provided  Connect the flat connector  to the Otoport with the arrows facing upwards and the square connector to  the back of the printer              n     O    Taaa a a    Printer cable socket  The wireless printing method has a range of up to 10m in direct line of  sight  Itis recommended that the printing distance is reduced to 5m to help  ensure robust communication  Remain 
3.      11 1       11 1 f    11 1 9    11 1 h    Otoport Lite   101  User Manual    Remove the tip from the probe and place the cavity on a flat surface  Insert  the probe into the test cavity at a 90 degree angle to the top of the cavity   between the screws  as shown below left  Press the probe firmly into the  cavity until the shoulder of the probe touches the top of the cavity  When  released  the probe will rise a little to its natural position and the shoulder  may no longer touch the cavity  Inserting the probe at the wrong angle   or with the probe head over one of the screws may result in incorrect test  results        Select OK to begin the Probe Test or Cancel to return to the Probe Menu  screen     The probe outputs sound at 1  2 and 4kHz via its loud speaker s   There  is one loud speaker in the UGS  TEOAE  probe and two in the UGD   DPOAE  probe  The Otoport compares the response at each frequency  against an absolute range and probe specific values stored on the probe  connected     Checking the probe response against the absolute range determines if  the probe is OK for use  Checking the probe response against the probe  specific values is more sensitive and provides a warning if the response of  the probe has changed     Probe checks    102   CHAPTER ELEVEN  Probe checks    11 1 1    11 1 1 a    11 1 1 b    11 1 1 c    i Wg      11 1 1       Results    The possible results of the test are     Pass       OK    The levels recorded at all frequencies are within the
4.      If a user has been assigned Administrator rights  an A will be present in the  right hand Status column of the table     Edit user    Select Edit to alter the details of a highlighted user     Select Save to save changes to the user   s details and return to the User  List     Select Delete to remove the selected user from the User List  A  confirmation message will 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 possible to delete the default    Admin    user     The message Cannot Delete  User has tests in database will appear if  the user has performed tests that are still present within the database  It is  necessary to delete all Patient Records from the device prior to deletion of  users  Note  Patient Results should be downloaded to PC first     c     we             5   D   m   S   o   Oo       84   CHAPTER EIGHT  Configuration    8 6 2 i Select Cancel at any time to discard changes and return to the User List     8 6 2  Settings  862k Select Settings to turn the Login facility On or Off     8 6 2 1 Select Save to save a change to the settings or Cancel to turn to the  Users menu     Otoport Lite   85       User Manual  9 Printing  o1 Printer accessory  9 1 4 An Otoport mini printer is available as an optional accessory  The printer    is used to create a paper record of the OAE test results recorded on the  Otoport  The Otoport either communicates with the printer using B
5.      It is the responsibility of the user to ensure that the pass criteria set meet  their requirements     DP stimulus calibration    CALIBRATING          Before starting the test the Otoport will calibrate the levels of the stimulus  tones which are to be used in the test  This is necessary to account for the  acoustic properties of individual patients    ear canals  If the required levels  cannot be reached then the Otoport will display the message Unable to  calibrate  Check probe fit and return to the checkfit screen     If calibration fails  check the probe fit and check that the probe coupler  tubes are clear  Excessive noise may inhibit calibration  so ensure  environmental noise levels are low  Make sure a DP  UGD   grey  probe is  connected to the Otoport and not a TE  UGS   red  probe     Test    46   CHAPTER FIVE    Test    5 3 1 c    5 3 1 d    5 3 1 e    5 3 2    5 3 2 a       3 2 b    5 3 2 C    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 and replace if necessary  then run Probe Checks  see  chapter 11  to test the probe and Otoport performance     Following Stimulus Calibration  the OAE recording begins and data is  collected     With Neonate mode On  the user is warned if the response from the probe  indicates a large ear canal  see 5 2 1 d graphic and section 8 3 5      A     Probe out of ear  of large cavity    detected  
6.    Location 4 In Patient    Facility Hospital       CANCEL RECORDS SAVE    Zid    2   1 a    24 00    2 7 8    2 7 8 a    2 7 9 a    2 1 9 b    2 7 9 c    2 7 10    2 7 10 a    Otoport Lite   23  User Manual    Deleting characters       The bottom right hand Contrast Delete key is used as a delete key  If the  cursor is at the end of a row of characters  press this key to delete the last  character     Left and right arrow keys can be used to scroll back through the text  The  selected blinking character can be replaced using the keypad data entry  keys or deleted with the delete key  Continue to press the delete key to  erase characters to the right of the cursor     Backlight    The screen and keypad are backlit to assist in testing in dimly lit  environments  The backlight stays on for 7 seconds following any key  press and remains on during testing  The backlight can be configured  see  chapter 8 Configuration      Stimulus and Noise OK indicators  blue LEDs     The two blue LEDs above the screen on the Otoport give an indication of  whether stimulus and noise levels are acceptable for data collection     The Stimulus LED is marked with an S  It is lit when the stimulus level  recorded by the probe microphone is within the expected range     The Noise OK LED is marked with an N  It is lit when the noise level  recorded by the probe microphone is below the set noise reject level  see  chapter 8 Configuration      Hard reset    In the unlikely event that the Otoport fails t
7.    Poor Probe Fit  Er     No Valid OAE    Too Few Bands    Stopped Too  Soon    Description  The data collected has met the criteria set     The optimum test setting will depend on your  application  see 8 3 Test settings     The following results will only occur if a TEOAE Pass  is not obtained    The noisy data collected is three times greater than  the low noise data collected    Probe movement has been detected    The data collected has not met the set pass criteria  and the test conditions were acceptable    Insufficient bands meet their pass criteria    The test was ended manually before the  required minimum amount of data has been collected    5 3    5 3 a    5 3 b    5 3 1    5 3 1 a    5 3 1 b    Otoport Lite   45  User Manual    DP Test  DPOAE model     During testing the Otoport plays pairs of tones at different frequencies   into the ear and records the response  The OAE signal is very small and  difficult to distinguish from the noise made by other sounds in the room   and by the patient  The longer the Otoport records for  the easier it is   to distinguish the OAE signal from the noise  The Otoport looks at the   ratio of the OAE signal to the noise  this is known as the Signal to Noise  Ratio or SNR  The Otoport measures the SNR in a number of different  frequencies  The pass criteria is set in the Configuration area  see  chapter 8 Configuration   The default pass criteria is an SNR of 6dB and a  minimum signal of  gt  5dBSPL in at least three frequency bands
8.    Probe checks should be carried out on a weekly basis     There are four different probe checks  described below  The Probe Test  is initiated from within the Configuration menu  the Cavity  Occlusion and  Real Ear tests involve running a standard TEOAE or DPOAE test     Probe checks    100   CHAPTER ELEVEN  Probe checks    n   Probe test    CONFIGURATION PROBE  UGD C 108003    A E    Probe Test     L NEY ri LD NEW    2 Test Settings    76 4175 7176 sve A   gt  KHz tle  78 4 78 5 77 91       atd 6 7 75 876 776 10      3 Date  amp  Time  4 System  5 Users       BACK SAVE RETEST    11 1 4 Probe Test is an option accessed from the configuration menu  see  chapter 8 Configuration      11 1 b A Probe Test should be performed regularly to monitor the calibration of  the probe s output stimulus level and microphone response     11 1    Note     Probes supplied with a new Otocheck system are tested with the  system and Probe Test levels are stored  These levels form a  baseline to compare future tests against in order to monitor any  calibration drift  It is not necessary to save a new baseline level  for these probes     Replacement probes supplied should be tested with your  Otocheck system and new Probe Test results saved as a  baseline reference  see 11 1 1    below      itid On selection of Probe Test the message Place Probe into Otodynamics  Test Cavity  Press OK to begin test  will be displayed     0    Place probe into  Otodynamics test    cavity  Press OK  to begin test   
9.    The Rapid mode is appropriate for secure detection of the presence of  OAEs at a set number of frequencies for screening purposes  A good  Signal to Noise Ratio  SNR  in this mode indicates high confidence level  that an OAE is present     The Standard mode can also be used for screening but only in quiet test  conditions  Tests will take longer than the Rapid mode and the confidence  level of the result will exceed that needed for screening     Otodynamics does not recommend the Rapid mode for clinical  measurements as the dBSPL accuracy may not be sufficient to quantify  changes over time     Further details of the Noise Modes are included in chapter 19  Mode of  operation     8 4    8 4 a    8 4 b    8 4 c    8 4 d    8 4 e    8 4 f       Otoport Lite   75    User Manual    Date and time    DATE  amp  TIME    10 46 24Hr      01 Feb 2012    dd  Mmm yyyy    The date and time set on the device can be altered in the Date  amp  Time  screen     When the Date field is highlighted press the right arrow key to access the  calendar pop up table  By default  the day will be highlighted first and can  be altered using the up  and down arrow keys  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 dd Mmm yyyy and mm dd yyyy  or dd mm yyyy via the choice bar     Select Save to set the current date and time settings and return to the  Configuration sc
10.   9             142    CHAPTER TWENTY ONE  Technical specifications    Guidance and manufacturer   s declaration     electromagnetic immunity    The Otoport is intended for use in the electromagnetic environment specified below  The customer or the  user of the Otoport should ensure that it is used in such an environment     Immunity IEC 60601 Compliance Electromagnetic environment    test test level level guidance    Portable and mobile RF communications equipment  should be used no closer to any part of the Otoport  including cables  than the recommended separation  distance calculated from the equation applicable to the  frequency of the transmitter     Recommended separation distance    Conducted RF 3 Vrms 3 Vrms d 1 2 P  IEC 61000 4 6 150 kHz  to 80 MHz  Radiated RF 3 V m 3 V m d   1 2VP 80 MHz to 800 MHz  IEC 61000 4 3 80 MHz d   2 3 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      should be less than the compliance level in each  frequency range       Interference may occur in the vicinity of  equipment marked with the following symbol              Notes   1 At 80 MHz and 800 MHz  the higher frequency range applies     2 These guidelines may not apply in all situations  Electromagnetic propagation is  affect
11.   CANCEL CHECKFIT START       Test screen    The Otoport looks at the ratio of the OAE signal to the noise  this is known  as the Signal to Noise Ratio or SNR  The Otoport measures the SNR in a  number of different frequencies     The display shows a series of small circles  each representing the SNR  recorded at a particular DP frequency  The numbers below the circles  indicate the F2 frequency in kHz        The pass criteria are set in the Configuration area  see chapter 8  Configuration   The default pass criteria are an SNR of 6dB  a minimum  signal of  gt  5dBSPL and at least 1 28s of data collected in at least three  frequency bands     5 3 2 0    5 3 2 e    5 3 2 f    5 3 2 g    5 3 2 h    5 3 2 i    5 3 2     5 3 3    5 3 3 a    5 3 3 b    5 3 3 c    5 3 3 d    5 3 3 e    Otoport Lite   47  User Manual    It is the responsibility of the user to ensure that the pass criteria set meet  their requirements     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 good testing conditions  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 green if it is below   The noise level shown is calculated from the peak sound level recorded  within each response window     The letter below the indicator represents the noise reject threshold l
12.   D   m   S   o   Oo       18    CHAPTER EIGHT  Configuration    8 5 3    8 5 3 a    8 5 3 b    8 5 3 c    8 5 3     8 5 3 e    Battery  BATTERY    Charge o7      Time 529 min  Health g1 3   Voltage 4 0V    ICECECETI       BACK CONDITION    The Battery screen provides information on the current battery status  The  total Battery Power remaining is displayed as a percentage and as an  approximate operation time  The calculated time is only an approximate  indication as the power requirements will vary depending on the mode of  operation     The Battery graphic on the right of the screen conveys the total remaining  Battery Power  The battery segments are shaded according to the  following criteria     Segments Displayed Battery Power      95   100  75   94  55   74  40   54  30   39  20   29  1 10   19  0  lt  10    NM      AJ aI OIN    The Battery Voltage and Health values are provided as a diagnostic tool  at the bottom of the screen     The battery graphic is also displayed on the Logo screen to inform the user  of the Battery Power every time the device is switched on     Select condition to discharge the Otoport battery  See chapter 15 Otoport  power for more information     8 5 4    8 5 4 a    8 5 4 6    8 5 4 c    8 5 4 d    8 5 4 e    8 5 4 f    8 5 4 9    8 5 4 h    8 5 4 i    8 5 4 j    8 5 4 k       Otoport Lite   79  User Manual    Setup    SETUP    Quick Save   Print Manual  End Print Test  Print type Detailed    T    CANCEL SAVE    Quick Save    If Quick Save is 
13.   scroll down to the last line  which  will be empty  then select Add  If your Otoport has RFID or Bluetooth  facilities  you may enter patient details by selecting Scan     Complete the required details  The ID Notes and Name fields are prefilled  but can be over written     PATIENT DETAILS    ID    Motes OGPM2100  Name Brooks    D O B 01 Feb 2012  a Male  gt      BACK SAVE TEST    60   CHAPTER SIX    Worklist    6 1 c    6 1 d    6 2    6 2 a    6 3    6 3 a    When details are complete  select Save to save the details to the Worklist   Test to run a test on this patient  or Back to discard these patient details     Up to 50 patients may be added to the Worklist     Testing from the worklist    WORK LIST wa  NAME ID INOTES  Roberts OGPMiVoO2    OGPM1IVOS  OGPM1VO04       DELETE DETAILS TEST    Scroll to the required patient  Select Test to begin testing this patient   When a test has been saved to a patient those details are removed from    the Worklist     Editing details    Scroll to the required patient  Select Details to edit  The options available  are the same as when adding a patient     6 4    6 4 a    6 4 b    Otoport Lite   61  User Manual    Deleting patients    Scroll to the required patient  Select Delete to remove     CONFIRM DELETE       Select Yes to delete the selected patient from the worklist  Select All  to delete all of the patients from the worklist  Select No to return to the  Worklist without deleting any patient details     62   CHAPTER SIX    Workl
14.  2 Electromagnetic Compatibility  21 3 EN60645 3 conformance notes  21 4 Symbol explanations    22 Index    126    126  126  126    128    129    130    131    132    132  134    135    135  139  144  146    148    Otoport Lite 7  User Manual          2  er    3            e   d  ww          8   CHAPTER ONE  Introduction    1    1 0 b    1 0 d    Introduction    The Otoport provides high quality OAE measurement features in a  compact  handheld format  Different models are available to perform either  TEOAE or DPOAE tests     The Otoport is simple to use and with powerful measurement features  performs an automatic analysis of cochlear status within seconds   Customisable pass criteria control the test s automatic stop mechanism and  a clear Pass Refer indication is provided     The Otoport   s impressive list of features includes     TEOAE Quickscreen or DPOAE testing  Ultra fast interactive graphic display  ILO Gold Standard data format  Frequency band analysis   Cell phone type keypad   500 record secure database   Long battery life    Options     e Wireless Printer  e Docking Station     RFID Scanner   e Barcode Scanner    1 1 b    1 1 d    1 1 f    1 1 9    a    Otoport Lite   9    User Manual    General use precautions    s    TRAINING  REQUIRED       The Otoport pass criteria are set in the Configuration area  see chapter 8  Configuration   Itis the responsibility of the user to ensure that the pass  criteria set meet their requirements     Measuring OAEs requires that 
15.  36N  Jan 27 2012 12 01 53    OO00007 72EFO  OP  UGB C108003       8 5 5 e The About screen provides information relating to the Otoport   s  identification and mode of operation  The firmware revision number and  issue date is stated  together with the unit   s unique hardware ID  If a probe  is connected  the Probe ID will also be displayed for reference     c     ad  6      5  D   m  S      Oo       82   CHAPTER EIGHT    Configuration    8 6    8 6 a    8 6 b    8 6 c    8 6 d    8 6 1    8 6 1 a    8 6 1 b    Users    1 Add New User  2 View Users    3 Settings       Select Add New User to enter details of a new user and save to the User  List  Adding users to the Otoport allows test results to be attributed to  individuals 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 Settings to turn Login on or off     Select Back to return to the Configuration Menu screen     Add New User    To add a New User  complete the field entries shown on the New User  screen  The following table describes the field choices available     Field    Name    User ID    Password    Admin    Description Max No  Characters  User   s name that appears 8   at Login   The user   s unique 3   identification  capitalised only     This is attached to a test  record when saved to the database    An alphanumeric password 8   required for secure login  capitalised only    optional    Select Yes to give the n
16.  8 4  8 5  8 6    9 1  92  9 3  9 4  9 5  9 6  9 7  9 8    Patient list    Configuration    Configuration menu  Probe test   Test settings   Date and time  System   Users    Printing    Printer accessory  When you can print  The printing process  Printer fault detection  Printer light summary  Paper   Charging the printer  Changing the battery    10    11    12    13    14    15    scanning    10 1 Scanning facility  10 2 Scanner types  10 3  When to use the scanners    Probe checks    11 1 Probe test   11 2 Cavity test   11 3 Occlusion test  11 4 Real ear test    Probe  tips and accessories    121 Probe and service accessories  12 2 Probe cable clip  12 3 Probe tips    Probe care    13 1 Cleaning  13 2 Changing probe coupler tubes  13 3 Probes safety note    Care of the Otoport Lite    14 1 Use of the Otoport and cleaning    Otoport Lite power    15 1 Battery life   15 2 Initial charge   153 Standby   154 Battery charge   15 5 Charging the Otoport   15 6 Conditioning the Otoport battery    95    95    97    99    100  105  106  107    108    108  109  110    113    113  113  115    116    116    118    118  118  119  120  122  125    Otoport Lite   5  User Manual    i    16 Troubleshooting    16 1 Otoport lock up   16 2 Switch on   16 3 System details   164 Instrument fault message  16 5 Hardware fault messages    17 Training  18 Obtaining service  19 Calibration    20 Mode of operation    20 1 TEOAE model  20 2 DPOAE model    21 Technical specifications    21 1 General   21
17.  Check the subject has no middle or outer ear problems  such as a cold or  wax blockage  which might prevent OAE recording     e Check a good probe fit has been achieved    e Check that the probe is not blocked    e Check the probe still passes the probe calibration test  see above    e Try recording emissions from another subject     If you are still unable to achieve a Real Ear OK result then  if the resources  are available try recording with a different probe or with a different Otoport   If the problem persists  contact your dealer or Otodynamics     Probe checks    108   CHAPTER TWELVE  Probe  tips and accessories    12    12 1    12 1 a    12 1 b    12 1 c    12 1 d    Probe  tips and  accessories    Probe and service accessories    Your kit will include either a TEOAE or DPOAE probe  with appropriate  accessories and sample probe tips  depending on the Otoport model  purchased     UGS TEOAE probe  red  or UGD DPOAE probe  grey  with screw locking  connector  see 2 8 Connecting the probe      TPC Coupler Tubes for UGS probe or DPC or UGD  See chapter 13  Probe care for information on changing coupler tubes     BGS Body  amp  Lid for UGS probe or BGD Body  amp  Lid for UGD probe                   Otoport Lite   109  User Manual    22 Probe cable clip       12 2 4 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  clip can improve your test times by reducing noise from cabl
18.  Collateral standard   programmable electrical medical systems    UL 60601 1  Medical Electrical Equipment  Part 1   General Requirements for Safety    CSA C22 601  Medical Electrical Equipment    21 2    Otoport Lite   139  User Manual    Electromagnetic Compatibility    The Otoport should be put into service according to the EMC  Electromagnetic  Compatibility  information provided here     Portable and mobile RF  Radio Frequency  communications equipment can affect  the operation of the Otoport  In particular  mobile telephones     cellphones     should  not be operated within 3 3m of the Otoport     The use of probes  chargers and connection cables other than those supplied by  Otodynamics Ltd  and specifically for use with the Otoport may result in increased  emissions or decreased immunity of the Otoport     Guidance and manufacturer   s declaration     electromagnetic emissions  The Otoport is intended for use in the electromagnetic environment  specified below  The user of the Otoport should ensure that it is used in such    an environment     Emissions test Compliance   Electromagnetic environment    guidance    RF emissions The Otoport uses RF energy only for    CISPR 11 its internal function  Therefore  its RF  emissions are very low and are not  likely to cause any interference in  nearby equipment    RF emissions Class B The Otoport is suitable for use in all   CISPR 11 establishments  including domestic    establishments and those directly  connected to the publ
19.  absolute range and  within   3dB of the probe specific values     Fail       One or more of the levels recorded are outside the absolute range  specified for the probe  If a Fail is shown on screen inspect the probe  coupler tubes for debris  replace the coupler if necessary and repeat the  Probe Test  by selecting Retest  ensuring the ear piece is firmly inserted  in the test cavity  If the test continues to fail there may be a fault with the  probe or system  Contact your dealer or Otodynamics for advice     i a    11 1 1 g    11 1 1 h    11 1 1 i    14145    Otoport Lite   103  User Manual    Query       The levels recorded at all frequencies are with the absolute range but one  or more frequencies is more than   3 dB of the probe specific values  If   a Query is shown inspect the probe coupler tubes for debris  replace   the coupler if necessary and repeat the Probe Test by selecting Retest   ensuring the ear piece is firmly inserted in the test cavity  A Query result  indicates that there have been changes in the probe but that these changes  are not large enough to invalidate testing  It may be possible for the probe  calibration to be adjusted if the probe is returned to Otodynamics     Noisy       There was significant noise during the calibration test  This noise may  have influence the levels recorded so a Retest should be performed     Select Back to exit the probe test and return to the Probe Menu screen     Probe checks    104   CHAPTER ELEVEN  Probe checks    1
20.  been contaminated  The body  and lid should be replaced if contaminated  Visually check the ear piece for  signs of dirt before each test     Otoport Lite   117  User Manual    14 1  Before fitting each tip  ensure the sound tubes are carefully examined for  any sign of debris that may have entered them  Replace any part of the  probe ear piece as necessary   See chapter 13 Probe care for details     14 1    Ensure your hands are cleaned thoroughly between each patient tested     14 14 Clean the Otoport each day before a testing session  or according to local  requirements  Ensure the Otoport 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 liquid to enter the instrument and do not immerse in fluid  Do not  allow liquid to come into contact with the connection sockets  Do no poke  any materials into either the probe or charger pc cable sockets     14 1 9 If additional hygienic protection is required  use the Otoport in an infection  control sleeve  This can also be cleaned with a sterile wipe or cloth with  antiseptic fluid  The sleeves are disposable  so should be replaced weekly  or after approximately every 50 tests        bm  Q  Q    e   ar  O  Q        y    e   Q  S               118   CHAPTER FIFTEEN  Otoport power    15    15 0 a    15 1    15 1 a    15 2    15 2 a    Otoport Lite power    Important Note     Only cha
21.  fault  If  this message is displayed  turn the unit off  disconnect the probe and then  turn it back on  If the message is consistently displayed with the probe  disconnected  then contact Otodynamics     17    17 0 a    17 0 b    17 0 c    17 0 d    17 0 e    Otoport Lite   129  User Manual    Training    It is important that the operator of the Otoport is properly trained before  using the instrument  The manual should be read before use and note  taken of the sections marked with the training required symbol     TRAINING  REQUIRED       Where the training symbol is directly beneath a chapter title  it indicates that  training is required for everything within the chapter  Where the symbol  appears beneath a section heading  it indicates that training is required for  that section 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 by previously trained  staff and qualified audiologists     Ensure your local policy for infection control is followed  as well as reading  the recommendations in this manual  see section 20 1 Use of the Otoport  and cleaning      If a problem occurs during the operation of your Otoport or Otolink software  or a message or warning appears that you don   t understand  make note of   the issue and messages provided  Refer these to your department lead  or   directly to Otodynamics or your dealer
22.  for support     130   CHAPTER EIGHTEEN  Obtaining service    18    18 0 a    18 0 b    18 0 c    18 0 d    Obtaining service    Otodynamics or its authorised distributor will replace or service  free of  charge  this Otoport for a period of 12 months from the date of purchase   where the fault is not associated with misuse  Servicing after that period  will be provided at reasonable cost     Probes failing because of faulty construction will be replaced subject to  inspection  Probes must be treated with care  Do not allow cleaning fluid to  enter the sound tubes     When sending 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 be contamination free when returned to you and suggest that it is  cleaned in accordance with your infection control protocols before being  put back into use     Please contact your distributor or Otodynamics for advice before returning  an item for repair  You will be asked for your instrument serial number   which can be found on the back on the Otoport     Otodynamics Ltd    30 38 Beaconsfield Road  Hatfield   Hertfordshire AL10 8BB  UK    Tel   44 1707 267540  Fax   44 1707 262327  E mail  support otodynamics com       www otodynamics com    19    19 0 a    19 0 b    19 0 c    Otoport Lite   131  User Manual    Calibration    The Otoport is a precision instrument designed to make accurate  me
23.  only does this pose a contamination risk  but OAEs  cannot be recorded through fluid     In the event of an accident with body fluids  the tip  coupler tubes and  probe body must be changed     Otoport Lite   113  User Manual    13 Probe care    S    TRAINING  REQUIRED       31 Cleaning    13 1 a The following is the suggested method of cleaning an Otodynamics probe   It should be noted that the probe is a precision assembly and  as such   care should be taken throughout in its handling and cleaning     13 1 b Cable   The cable may be cleaned with antiseptic fluid or wipes     13 1    Probe casing   The probe casing may be cleaned using antiseptic wipes  and dried with a tissue immediately afterwards  Do not allow liquids to  enter the sound tubes     13 1 d Coupler assembly   Each coupler assembly has two sound tubes  These  are protected from ingress of foreign materials by wax guards in the tubes  and by the disposable probe tip  There is a loudspeaker at the end of one  tube and a microphone at the end of the other  Cleaning solution must not  penetrate the tubes     2 Changing probe coupler tubes       13 2 a The probe has sound tubes combined into a single coupler assembly that  can easily be replaced at regular intervals or when contaminated     Q  in       s       2   e   in  Bo        114   CHAPTER THIRTEEN  Probe care    13 2 1    13 2 1 a    13 2 2    13 2 2 a    13 2 3    Disassembling the probe    First  unplug the probe from the instrument  Remove the tip and t
24.  referred to as waveforms A and B     Otoport Lite   133  User Manual    Signal and noise calculation  Measures of signal and noise levels are based  on the correlation and differences between  waveforms A and B     Stimulus repetition rate  One stimulus every 13ms  approximately 80 stims  per second     Response window  2 5 12 5 ms or 4 10ms after start of stimulus   Cosine filtered with rise and fall time of 2ms     Response frequency bands  Half octave  centres at 1  1 4  2  2 8 and 4kHz     Response frequency range  841 4757Hz    Microphone input filter  1189 4757Hz  The attenuation at these frequencies is 3dB   Attenuation increases by 80dB decade below and  40dB decade above these frequencies     Memory capacity  Patients 500  Tests per patient 256  Total tests 500          e   Pa        S   i    Q   e     m    e    3   Le    e           134   CHAPTER TWENTY  Mode of operation    20 2    DPOAE model    Parameter Description    Checkfit stimulus  80us positive broadband square wave pulse with an  intensity of 64dB pe  peak equivalent  in a 1cc cavity     Sample rate 25 6kHz  Sample buffer 80ms  gives 2048 points     FFT frequency bin  25Hz    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 points gives the  noise level  In the    Standard    noise mode the mean of  these points plus two standard deviations gives the  noise level     Noise rejection calculatio
25.  remaining  If the central soft key is pressed  an E  will be displayed and the test will run until autostop criteria are met  it is  manually stopped or the absolute limit for testing is reached     Start    With Start set to On  default   the testing will proceed from Checkfit to  Test as soon as the Otoport detects a stable probe fit  without the need for  the user to select Start     With Start set to 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 key is available in order that the  user can initiate a test     DP Stims  DP only     This sets the target stimulus levels for the tones L1 and L2 that are  represented during the test  The options available are     60 50  60 55  65 50  65 55  70 70    Higher intensities give a less sensitive hearing screen but may be  necessary to record a response in older patients     c     ad             5   D   m   S   o   Oo       74    CHAPTER EIGHT    Configuration  s310 Noise mode  8 3 10 a Noise mode sets the method by which the noise floor in DP tests is    8 3 10 b    8 3 10 c    8 3 10 d    8 3 10 e    8 3 10 f    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 frequency  A good Signal to Noise Ratio   SNR  in this mode indicates that a high accuracy of measurement has  been reached  
26.  test time 300 seconds   Max low noise  NLo  260 sweeps of 16 stimulus presentations  sweeps averaged   Ring reject  20dB    Max ratio of stimulus peak to the level 3ms after stimulus presentation   Stimulus ring can hamper accurate OAE measurement    Input filter 1189Hz   475 7Hz or 1600 3200Hz   narrow mode only     The attenuation at these frequencies is 3dB  Attenuation increases by 80dB decade  below and 40dB decade above these frequencies    8 3 3 g    8 3 4  8 3 4 a    8 3 4 6    8 3 4 c    Otoport Lite   71  User Manual    The default setting is Any 2 Bands  However  it is recommended that you  carefully choose pass criteria which suit your particular screening program     Configurable test parameters    Name Any 2 Any 3 Any 4 Wide Narrow  Min pass   bands 2 3 4 None None   Min total  wide   band  SNR None None None 6dB 6dB   Min SNR per   pass band 6dB 6dB 6dB None None  Filter  Hz  1189 4757 1189 4757 1189 4757 1189 4757 1600 3200  Response    Window  ms  2 5 12 5  2 5 12 5 2 5 12 5 2 5 12 5 4 10    Mode  DPOAE     Mode sets the pass criteria for screening     The Any 2 Bands  Any 3 Bands and Any 4 Bands settings require a 6dB  SNR and a minimum signal level of  SdBSPL in each of the stated number  of half octave frequency bands to meet the pass criteria     The default setting is Any 3 Bands  However  it is recommended that pass  criteria is carefully chosen to suit the particular OAE testing programme     Fixed test parameters    Min band signal  5dBSPL  Max test 
27.  the front of the printer has a number of colour combinations   which indicate various conditions     Constant green   Normal operation  running on battery power     Flashing green  The printer is storing print information  spooling  that  cannot be printed at the time  e g no paper  or printer lid open     Flashing green orange   Battery is being charged  Red   Low battery or other problem    No light   Unit is in sleep mode  has a flat battery  or the battery is not  connected    92   CHAPTER NINE    Printing    9 6    9 6 a    9 6 b    9 6 c    9 6 d    9 6 e    Paper    When the printer is switched on  the button provides a paper feed function   A double press of the button will initiate a test print     The printer is supplied with spare paper rolls  To change the printer roll   pull the lid release catch  1  forwards with your thumb and the paper roll lid  will spring open        Unwind a 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 using  the paper feed function  and  tear off any excess by pulling  the paper sharply towards you  across the serrated tear bar    In the event of a jam or other  paper loading problem  release    the lid and straighten the paper    before closing again     Self adhesive paper rolls   are also available and may  be used in the same way as  standard paper  but can be  stuck to y
28.  there  are other saved test records for this patient  The left and right arrow  indicators display the Patient Details for this patient     Select Print to print an individual test record     Select Back at any time to exit the test summary screen and return to the  Patient List to review tests of an alternative patient     N  xo   i   0  0     x       66   CHAPTER SEVEN  Records    TEOAE test summary screen    No  of Test saved to    Test type  the patient record    Patients Name       Test Result  Stimulus level  Ear Tested TEOAE  R  Right  or L  Left      gt  ae ae  Westie PASS Band Pass Indicators  Paean kw showing which bands  achieved their pass  1152 3 4 criteria  not shown if  Total OAE signal 31 Jan ADN Ue ae is Wide  level  ABSPL    and or Narrow     Time of Test  Total noise User ID  level  ABSPL   Date of Test    DPOAE test summary screen    Test type  Patients Name yP  Test Result No  of Test saved to  Brown the patient record  DPOAE  DPOAE PASS  Ear Tested a ANY3BANDS  65 5508 Stimulus Levels  R  Right  or L  Left     Pass Criteria  User ID    Total OAE signal  level  ABSPL        Band Pass Indicators  Date of Test  dots  showing which  Time of Test   frequency bands  achieved their pass  Test Duration criteria    8 1    8 1 a    8 1 b  8 1 c  8 1 d  8 1 e    8 1 f    8 1 9    8 2    8 2 a    Configuration    TRAINING  REQUIRED    CONFIGURATION     1 Probe Test   2 Test Settings  3 Date  amp  Time  4 System    Configuration menu       Otoport Lite   67  User Ma
29. 1 1 1 k    11 1 1     11 1 1 m    11 1 1 n    11 1 1 0    11 1 1 p    11 1 1 q       Details    PROBE    UGD C108003    A B      OLO NEW OLD NEW      75 4 75 776 575 80      Madera 3 1 78 478 577 90  Maca 76 7  75 8 76 7 78 1       BACK SAVE RETEST    The full test result can be viewed by selecting Details  The details screen  shows the levels recorded from the probe loud speaker at each frequency  tested  The NEW column shows the levels just recorded and the OLD  results are the levels that are stored in the probe     Results are given for each frequency tested     Pass    Tick Check mark           The NEW and OLD  Stored  data for each of  the two channels are within   3dB and are within the absolute limits     Query   Question mark     Values differ by more than   3dB  The NEW  and OLD levels are highlighted     Fail     Cross  X  Values are outside the absolute range  The NEW level  only is highlighted     The 1  2 and 4kHz values may not be stored in the probe if a new probe is  being used with the system  To save new data  run a Probe Test  record the  values 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 available if the test was  noisy or if the levels were outside the absolute range     On selecting Save  the screen title Overwrite Stored  will be shown  highlighted  Select Yes to save the new data or No to keep the curren
30. 133  Response window 133   Result 58   Results 65   RFID scanning 96   Ringing 37    S    Sample buffer 134   Sample rate 134   Save 53   Scanner 16   Scanning 95   Select Ear 54   Serial number 16   Service 130   Signal and noise calculation 133  Speaker 15   Standby 119   Start 73   Stimulus 132   Stimulus Adjustment 37  39  Stimulus and Noise OK indicators 37  Stimulus frequencies  F2  134  Stimulus LED 23   Stimulus pattern 132  Stimulus repetition rate 133  Switch on 27   Symbol explanations 146  System 76  77   System details 126    T    Test Result 44  49  Test screen 40  46  Test settings 68   Test timeout 42  47  TE Test 38   Tips 110   Tip selection 32   Too Few Bands 44  49  TPC 108   Training 129    Otoport Lite   151  User Manual    U    UGS 108   Up down left right navigation buttons 15  User List 83   Users 82    W    Waveform sample rate 132  Worklist 80    152   CHAPTER TWENTY TWO  Index    
31. 14 0 b    14 1    14 1 a    14 1 b    14 1 c    Care of the Otoport Lite    TRAINING  REQUIRED         The Otoport is robustly constructed but is a precision instrument  so should  be handled with care  Be careful when connecting the probe  charger  PC  cable or printer cable     e Do not drop the Otoport   e Do not leave in strong sunlight   e Do not expose to high temperatures   e Do not touch the connector socket pins by hand   e Do not force the connection of the probe or charger PC cable printer  cable    Use of the Otoport and cleaning    The following is a suggested cleaning method for the Otoport and probe   The Otoport and accessories are precision assemblies  so care should be  taken throughout handling and cleaning     Other than the probe ear piece and cable  the Otoport hardware should  not come into contact with the patient being tested  Otodynamics probe  tips are disposable and for single use only  A new tip should be used for  each ear tested  The tip protrudes   0 5mm beyond the end of the probe  coupler  to prevent contact of the sound tubes with the patient     Between patients  wipe the probe ear piece and cable with an alcohol  based sterile wipe or cloth and antiseptic fluid  Dry the assembly with  tissue immediately afterwards and do not let liquid pass down the coupler  sound tubes  The probe ear piece is serviceable and its body  lid and  coupler tubes can be replaced  The coupler tubes should be replaced  weekly or after 20 40 tests  or if they have
32. 5 1 1 b  5 1 1 c    5 1 1 d  5 1 1 e  5 1 1 f  5 1 1 g  5 1 1 h    5 1 1 i    Checkfit    Checkfit display    CHECKFIT       It is important to perform a test in the appropriate conditions  The Checkfit  screen allows a user to assess the testing environment  Conditions such  as high ambient noise  poor fit of the probe in the ear  including leaks  and  blocked probes can be detected before starting the test     Excessive noise or a poor probe fit may mean that the test cannot be  performed or that the quality of data collected may be too low for an  accurate test result to be determined     Fit Size Indicator    The Checkfit screen shows a Fit 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 repeatedly plays a click at a fixed level and  records the sound level this click produces in the ear     The sound level recorded depends on the fit of the probe and the size of  the ear canal in which the probe is inserted     Ear canal size increases from birth to adulthood  So  given a good probe fit  the sound level recorded correlates with the age of the patient     For example  if the arrow is below the smallest ear  this indicates that the  sound level recorded is that which would be expected from a small ear  canal  You would expect this if you were testing a baby     Individual ear canals vary considerably in size  so the 
33. 5 cycles for 5 cycles    IEC 61000 4 11  70  Ur 70  UT   30  dip in Ut     30  dip in Ur   for 25 cycles for 25 cycles     lt 5  Ur  lt 5  UI    gt 95  dip in Ut      gt 95  dip in Urs   for5s for5s       Power frequency   3 A m 3 A m   50 60 Hz   magnetic field    IEC 61000 4 8    Electromagnetic  environment   guidance    Floors should be wood   concrete or ceramic tile    If floors are covered with  synthetic material  the  relative humidity should be  at least 30      Mains power quality should  be that of a typical  commercial or hospital  environment     Mains power quality should  be that of a typical  commercial or hospital  environment     Mains power quality should  be that of a typical  commercial or hospital  environment  If the user   of the Otoport requires  continued operation during  power mains interruptions   it is recommended   that the Otoport be powered  from an uninterruptible  power supply or a battery     Power frequency magnetic  fields should be at levels  characteristic of a typical  location in a typical  commercial or hospital  environment     NOTE Uz is the a c  mains voltage prior to application of the test level     Otoport Lite   141  User Manual    The following functions of the Otoport are deemed    essential performance    and were  tested for immunity in compliance with IEC60601 1 2      a  The collection of Otoacoustic Emissions  OAEs    b  The retention of user settings and test results               a  G  Q         G  2   N      s      
34. 7   3      Par     ov           22    CHAPTER TWO  Getting started    200    2 7 5 a    2 7 5   b    2 7 5 C    2 7 5 d    2 7 5 e    2 7 6 a    Entering dates    ENTER DETAILS ENTER DETAILS    ID Notes OGPM1V01 ID Notes OGPM1V01 _      Dec  2011    D O B dd Mmm  Yyyy AD  Eig Jan  Gender i NotGiven        CANCEL RECORDS SAVE       A right arrow symbol is shown at the end of a date field     When the field is highlighted  press the right arrow key to access the  calendar pop up table  The day will be highlighted first and can be altered  using the up and down arrow keys  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     Select Insert 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 of a future  date  Invalid D O B  will be displayed briefly at the top of the screen then  the date of birth will revert to today   s date  Re edit and confirm the D O B   if necessary     Choice bars    Left and right arrow keys are used to move through choice bar options   For example when entering patient details in the Gender field  pressing  the right arrow key will rotate the selected option between Not Given   Male  Female and Unknown  Choice bars options are enclosed by arrow  graphics     ENTER DETAILS    D O B 02 Jan 2012  Gender 4 NotGiven 
35. Cancel the test     In these circumstances Otodynamics recommends that the test is  cancelled  Efforts should then be made to improve the probe fit  check   the probe coupler tubes are clear and improve the test environment  If  adjustment 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 and replace if necessary  then run probe checks  see  chapter 11 Probe Checks  to test the probe and Otoport performance  If  stimulus adjustment is still unsuccessful  continuing the test may provide  useful results but it is likely that the stimulus level will be incorrect  This will  affect the level of OAE recorded     With Neonate mode On  the user is warned if the response from the probe  indicates a large ear canal  as shown below  see also section 8 3 5      a     Probe out of ear  or large cavity  detected    CANCEL CHECKFIT START       Test    40    CHAPTER FIVE    Test    5 2 2    5 2 2 a    5 2 2      5 2 2 C    5 2 2 d    5 2 2 e    Test screens    The test screen display depends upon the display option set from the  Configuration menu  see chapter 8 Configuration   The default display is  a simple One circle view     One circle    TE TEST       In the One circle display a single circle represents progress towards  meeting the pass criteria  The level of green displayed within the circle  represents the strength of the OAE detected compared with the level of  nois
36. Lo Sweeps  NLo sweeps are recordings made with a noise level below  the rejection threshold  is reached  This is a representation of the amount  of good data sweeps required before a No valid OAE result can be given     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 achieved  then the test will stop after 300 seconds   regardless of the amount of good data collected  This is to prevent  overexposure of stimulus in an ear and to limit the test time to allow for  reassessment of the ambient noise and of probe fit before a retest     Manual end    Selecting End at any time will stop the test     5 2 3     5 2 0 i    Otoport Lite   43  User Manual    Pausing and cancelling the test       CANCEL TEST              KHE       M  CHECEFIT YES    You may wish to pause a test for instance during periods of noise  When  the test is paused  it is possible to cancel the test and discard the data   Select Cancel to pause the test  Select Yes to end the test and discard the    data  No to resume the test and Checkfit to restart the test at the Checkfit  stage     Test    44   CHAPTER FIVE    Test    5 2 4    5 2 4 a    Test results    The following table lists all possible test results with the associated result  graphic and gives an explanation of the circumstances under which each  result would be shown     Test Result    TEOAE Pass          Note     Noisy  al T  IH 
37. OAE test uses short duration stimuli  During test setup a     rectangular stimulus    is used  During data collection a    bipolar stimulus    is used   The rectangular is a unipolar pulse of 78uS length  The bipolar stimulus is 1  cycle of a triangle waveform of 240uS period  Both stimuli are low pass filtered  by a 10kHz anti alias filter  which    rounds    any    sharp edges         b  Transducers and headband force     The stimulus is delivered to the patient   s ear using a UGS or UGD Otodynamics  probe  The probe tip holds the probe ear piece in the ear canal  with no  headband or other retaining device required      c  Sound field system   The sound field is generated by the probe sealed in the ear canal by its tip    d  amp  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 4157   The probe  was mounted in a DB2012 adaptor using an Otodynamics probe tip  The sound  ports of the probe were aligned with the 4157 reference plane  AUGD probe  was used for the calibration  Sound levels from the 4157 ear simulator were  measured in dB SPL peak to peak equivalent  as defined in EN60645 3      f  Signal levels     The following conversion factors convert between the stimulus level reported on  the Otoport screen and the signal level in the IEC 60711 occluded ear simulator     rectangular stimulus   6 1dB  bipolar stimulus   7 1dB    The follo
38. On then test results can be saved from the test result  screen with a single key push  see chapter 5 Test for details      If Quick Save is Off then options to enter patient details and review the  test result are available before test is saved     Print    If Print is set to Automatic then the test result is automatically printed after  the test is saved     If Print is set to Manual then the user has the option to print the test after  save     End Print    If End Print is set to Patient  then all the test results for the current patient  are printed at the end of the test     lf End Print is set to Test  then only the last test performed is printed at the  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 Print to  Automatic and End Print to Patient     c     ad             5   D   m   S   o   Oo       80    CHAPTER EIGHT    Configuration  8 5 4 1 Print type  8 5 4 m Print type controls the length and detail contained in the Otoport printout     8 5 4 n    8 5 4 0    8 5 4      8 5 4 q    8 5 4 4    8 5 4 5    8 5 4 t    8 5 4 u    8 5 4 v    8 5 4 w    8 5 4 x    8 5 4 y    The Summary format prints only core patient and test details  The  Detailed format prints a fuller set of patient and test quality details   See  chapter 9 2 4 for printout examples      On connect    On connect printing allows printing to be initiated as soon as a wired  printer is connected  Thi
39. Otoport Lite    User Manual          Otoport Lite  Issue 3          Otoport Lite    Issue C3   January 2013  Otoport Lite v3 24 1 0 onwards  Doc Ref  MANOLC 03    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     Copyright    2013 Otodynamics Ltd  All Rights Reserved     Otodynamics Ltd  onal 30 38 Beaconsfield Rd  Hatfield Herts AL10 8BB       Contents    1 Introduction    1 1    General use precautions    2 Getting started    2 1  22  2 3  2 4  2 5  2 6  2 1  2 8  2 9    Otoport Lite case contents   Optional accessories   Controls  indicators and connections  Scanner and labelling   Initial charge   Quickstart   Using the keys and keypad  Connecting the probe   Disconnecting the probe    3 Switching On    3 1  3 2  3 3  3 4    Switch on screen  Logo screen  Login   Main menu    4 Test preparation    4 1  4 2  4 3  4 4  4 5    General checks before testing  Connecting the probe   Tip selection and probe fitting  Helpful hints   OAEs and screening    31    31  31  32    34    Otoport Lite   3  User Manual            5 Test    5 1  5 2  5 3  5 4  5 5  5 6  5 7  5 8  5 9    6 1  6 2  6 3  6 4    Checkfit   TE test  TEOAE model   DP Test  DPOAE model   Quick Save option  Review   Save   Final review   Last   Result    Worklist    Adding Patients   Testing from the worklist  Editing details   Deleting patients        Records    7 1    8 1  3 2  8 3 
40. Pa    10  to 90  non condensing     lt 10s when unit is stored within stated temperature  range    Indoor use    5 to 40 Celsius    Max 80  up to 31C decreasing linearly to  5  RH at 40C    Otodynamics instruments and probes are calibrated at an ambient pressure of 101  kPa  standard atmospheric pressure at sea level   Lowering the ambient pressure    significantly  e g  when operating at altitude  alters the acoustic response of the  probe  For instance  at an ambient pressure of 80 kPa  standard atmospheric pres   sure at 2000m  changes of up to 2 dB can be observed in the response of the probe  around 2KHz  This could cause the probe to fail standard calibration tests     N        eel  G  0     0  Q  Q        G   lt   S  oan  Q  Q          138   CHAPTER TWENTY ONE  Technical specifications    21 1 11    Classifications and standards  Device Class 2a  Directive 93 42 EEC     BS EN ISO   13485 2003  REF  EN46001 superseded 01 03 2004   ISO 14971  Application of risk management   BS EN 60601 1  Medical Electrical Equipment Part 1     General Requirements for Safety    BS EN 60601 1 1  Medical Electrical Equipment    Part 1  General Requirements for Safety    Collateral Standard   Safety Requirements  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 electrical equipment   Part 1  General requirements for safety   Section 4
41. apter s Configuration     Quick Save On       RIGHT CANCEL LEFT    If Quick Save is On  select Left to save the test to the left ear  or Right to  save to the right ear     The test will be saved to the current patient or will be given an automatic  ID and name  This name and ID may be edited by selecting Last from the  main menu screen  see chapter 5 8      lf Automatic print is selected  see chapter 8 Configuration   the print  routine will be activated at this stage  After printing or immediately after  saving  the unit will return to the Main Menu     Select Cancel to proceed without saving the test  The user will be  prompted to confirm Cancel without save         CONFIRM CANCEL        Otoport Lite   51  User Manual    54 1 e After the save is confirmed  the option to retest the same patient will be  displayed  Select Yes to run another test on the same patient or No to  return to the main menu     Retest same    patient        54 2 Quick Save Off    5 4 2 4 If Quick Save is Off  select Save to enter Patient Details and then save  the ear tested        CANCEL SAVE REVIEW    54 2  Select Review to view the data of the completed test  prior to saving     54 2 Select Cancel to discard the test result  A prompt requiring confirmation  will be shown before the result is discarded     Test    52   CHAPTER FIVE    Test    5 5    5 5 a    5 5b    5 5 c    5 5 d    5 5 e    Review    The review screen shows the result of the test     If the display is set to One Circle  TE model 
42. arging status  indicators                Speaker    Charger and PC 3      cable socket    mo   Q     J         N  0   S  Pa     Q  9        16   CHAPTER TWO    Getting started    24 Scanner and labelling    BIE    Barcode RFID  scanner  not          included as  standard   ic fe  Hit o  i i   PE  Haye zo  pane ori  W  FAR L e4  FE ip    Pra  A      Pi Ej    Model  serial am    gt     number  ole  x  certification  s  a 4  manufacturer details HE E       The Otoport serial  number comprises  model code  LTC or  LDC in this instance    year and month   of manufacture   yymm  and unique  manufacture ID  xxxx    The complete serial  number is therefore  LTC yymmxxxx        Grip strip       jir  i    2 5    2 5 a    2 6    2 6 a    Otoport Lite   17  User Manual    Initial charge    Before using your Otoport for the first time  fully charge the unit  See  chapter 15 Otoport Lite Power for details     Quickstart    The Quickstart guide  included as a separate item in your document pack   is shown on the next two pages         Q     ae      de  7   3      Je     ov           18   CHAPTER TWO  Getting started     Ctodynamics    Audiology Systems    QUICKSTART    Otoport Lite    Setting up your Otoport    knurled sleeve    1 With the arrow at the front  2 Press the g button to turnon 3 The startup screen shows  connect the probe and the Otoport  Confirm within the date  time and battery  screw the knurled sleeve 2 seconds by pressing the   status   until finger tight  button     1 Sel
43. articular frequency  as with the  TEOAE Circles test display described above     Test frequencies  F2  for DPOAE are 2  3  4 and 6 kHz     c     ad             5   D   m   S   o   Oo       70    CHAPTER EIGHT  Configuration    8 3 3    8 3 3 a    8 3 3 5    8 3 3     8 3 3 d    8 3 3 e    8 3 3 1    Mode  TEOAE     Mode sets the pass criteria for screening     The Wide Band setting requires a signal to noise ratio  SNR  of 6dB over  the 841 4757Hz frequency range in order to meet the pass criteria     The Narrow setting also requires a signal to noise ratio  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 environmental noise on the  recording  This makes this setting particularly appropriate for screening in  a noisy environment     The Any 2 Bands  Any 3 Bands and Any 4 Bands settings require a 6dB  SNR and a minimum signal level of  SdBSPL in each of the stated number  of half octave frequency bands to meet the pass criteria     All test modes require a minimum overall  wide band  signal level of  OdBSPL and that the amount of data collected has reached a minimum  level to met the pass criteria     The fixed and configurable test parameters are summarised in the tables  below     Fixed test parameters    Min sweeps  NLo  30   Min total  wide band  OAE signal OdBSPL   Min band signal  5dBSPL   Stimulus level 84     1dB pe   Max
44. asurements of OAE responses  Before it leaves Otodynamics  each  system supplied is calibrated using high quality acoustic measuring  equipment traceable to national standards     Users should conduct the recommended weekly checks  see chapter 11  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 calibration checks at intervals not exceeding  3 years and ideally annually     Contact your dealer or Otodynamics to arrange a calibration check           Q  rar      i                  132   CHAPTER TWENTY  Mode of operation    20 Mode of operation    oi TEOAE model    Parameter Description    Stimulus Idle  80us positive broadband square wave pulse with an  intensity of 64dB pe  peak equivalent  in a 1cc cavity     Adjusted  80us positive broadband square wave     Test  300us biphasic broadband triangular pulse     Waveform sample rate  20kHz    Stimulus pattern  Each sweep presents 8 stimuli for each to the two  response buffers  16 stimuli in total   The stimulus  presentation pattern is   XXX Y  X  X  X  Y  Where  Y    3X    Response buffer averaging  The responses from each stimuli in a sweep are  summed and averaged     Averaging this stimulus pattern removes artefacts  which scale linearly leaving only the OAE signal  which is non linear     These sub averages are alternately added to two  separate averages  These separate averages are 
45. be changed  The correct  size tip will look slightly larger than the ear canal and should fit snugly   forming a complete seal with the ear canal wall        Fitting for newborns    Gently lift the pinna upwards  away from the baby   s head  and then towards  the back of the head  This will open the ear canal     Insert the probe at approximately 10 o clock  for left ear  or 2 o clock  for  right ear      Turn the probe ear piece to 12 o clock     Hold the probe for several seconds  Then release the pinna and let go of  the probe        4 3 2    4 3 2 a    4 3 2 b    4 3 2 c    4 3 2 d    4 4    4 4 a    4 4 b    Otoport Lite   33  User Manual    Fitting for children and adults  Line up the probe to 7 o clock  for left 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 weight of the probe   cable should be supported to minimise the risk of the probe being pulled  out during testing  Use the probe cable clip supplied  ensuring there is  sufficient slack in the cable to allow for movement of the patient   s head  If  the correct tip is used  the probe should stay in place without aid  However   it is acceptable to hold the probe gently in the ear if the patient is restless     Helpful hints    The most frequent cause of unsuccessful OAE recordings is failure to fit the  probe correctly  so that it is deep enough in the ea
46. charged and try again  If the Otoport still fails to complete its start up  sequence then contact your dealer or Otodyamics for support     System details    The Configuration area includes in the System menu a System details  screen     This screen provides information for Otodynamics engineers relating to the  Otoport hardware  If your device is not functioning correctly or you suspect  a fault  go to the System details menu and check for any error number  reported at the top of the screen  If zeros are reported at the top of the  screen  no errors have been detected on the device  For support regarding  a fault  report error numbers to your dealer or Otodynamics     Select Reset to reset the Otoport to factory default settings  Changes from  the default setting and any users or worklist patients added to the device  will be lost  No test data will be removed     Otoport Lite   127  User Manual    16 3 d Select Format to reformat the Otoport database  Any records held on the  device will be irrecoverably lost     16 3 e The Format and Reset options are only available to users with Admin  rights       a Instrument fault message    16 4 a In the event of an instrument fault  the following message will be displayed  at the start a test     Instrument Fault   Turm off Otoport   then run system checks    x    16 4 b Instrument fault  turn off Otoport then run system checks        16 4 c No stimulus will be delivered from the Otoport probe and you will not be  able to start a tes
47. ched 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 alternative printer  ALTER  or retry      amp     Printer not Found   Retry or search  for an Alternative  Printer     CANCEL ALTER RETRY       To retry the print  ensure the printer is switched on and is within range  5m    Then select Retry  If printing wirelessly and you have an alternative printer  available  select Alter  and the Otoport will connect to this printer     To cancel the printout  select Cancel     Once your print has completed  pull the paper sharply towards you across  the serrated tear bar to remove the printout and store it with your patient  records     9 4    9 4 a    9 4 b    9 4 c    9 4 d    9 5    9 5 a    9 5 b    9 5 c    9 5 d    9 5 e    9 5 f    Otoport Lite   91  User Manual    Printer fault detection    The printer can detect if the paper roll has run out  or if the lid is open     Under these circumstances the Otoport will report the printer is out of paper  and the following message will be displayed     OUT OF PAPER        Select OK to cancel the print job  Retry the printout when you have  rectified the problem    For wireless printing  print jobs sent to the printer will be stored  spooled   and printed when the detected condition is rectified  The printer   s green  light will flash when a print job is being stored     Printer light summary    The light at
48. ck sound from being omitted from the ear piece and to prevent  ambient noise from being read by the microphone  Then start a test as  normal     All the cavity size indicators in Checkfit should be filled  indicating a very  low sound level and Check probe fit should be displayed     If so  the Occlusion Test has passed     If not  check that the coupler is fitted to the probe correctly  making sure the  coupler tube ends are fully occluded by a finger and that the environmental  noise level is low  It may be necessary to change the coupler tubes   Repeat the test if necessary     11 4    11 4 a    11 4 b    11 4 c    11 4 d    11 4 e    11 4 f    Otoport Lite   107  User Manual    Real ear test    Testing with a known good ear allows for test data to be checked for  reproducibility     Before starting a real ear test  change the Test Settings Display to  Circles  see chapter 8 Configuration   This will help when comparing  results for reproducibility     A test may then be performed using the standard test procedure on the  known good ear  This result may then be compared with previous results  from the same ear  Real ear tests should be performed in similar test  environments to be comparable     Some adult ears with no significant hearing loss produce little or no  TEOAE  If possible the Real Ear Test should be performed on an ear  which is known to have strong TEOAEs        If you are unable to achieve a Real Ear OK result in an ear which is known  to have OAEs then     e
49. d     If the result Stopped Too Soon  Too Noisy or Poor Probe Fit is achieved   retest checking that the probe ear piece 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 either No Valid OAE or Pass result is  given     If Pass is shown at the end of the test or if the circle for any band is more  than 1 filled  save and retest making sure the ear piece has been firmly  pressed into the test cavity     Check the top of the test cavity and ensure it is securely attached to the  clear plastic part of the test cavity  If the resources are available  repeat  the test with a different test cavity and then with a different probe  This  will identify which component is responsible for the problem  Contact your  dealer or Otodynamics for further advice     Probe checks    106    CHAPTER ELEVEN  Probe checks    11 2 k    11 3    11 3 a    11 3 b    11 3 c    11 3 d    11 3       Note     If a signal is detected in the test cavity  ensure that five  successful cavity tests are performed on the Otoport before  returning it to use  Refit the probe in the cavity between each  test     Occlusion test    If the probe coupler is not fitted correctly  sound may leak between the  probe loudspeaker and microphone  The Occlusion Test helps 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 blo
50. dicates progress towards pass criteria     If all test criteria have been met  when the test is finished the circle will be  completely filled and show a large checkmark     8 3 1 6    8 3 1 1    8 3 1 9    8 3 1 h    8 3 1 1    8 3 1 j    8 3 1 k    8 3 1 1    8 3 2    8 3 2 a    8 3 2 6    Otoport Lite   69  User Manual    At the end of the test  a full circle may be displayed without a checkmark   indicating the SNR criteria have been met but not the minimum signal level  criteria     The default setting is One circle     If Circles is selected the information on OAE levels in half octave  frequency bands centred at 1  1 5  2  3 and 4 kHz is displayed during  testing     TE TEST       An empty circle means that OAE data has not yet been recorded at that  frequency  The circle fills from the bottom  indicating good quality OAE  data is being collected in that frequency region     As a circle fills  this indicates progress towards band pass criteria     If band pass criteria have been met  when the test has finished the circle  representing that frequency band will be completely filled and show a large  checkmark     When the test has finished  bands displaying a full circle without a  checkmark have met the SNR criteria but not the minimum signal level  criteria     The Circles setting is not available if Mode is set to Wide Band or  Narrow     Display  DPOAE     The display for the Otoport DP is Circles and cannot be changed  Each  circle represents the SNR recorded at a p
51. e recorded  the SNR   A fuller circle indicates that the SNR and signal  level are closer to the pass criteria     Circles    TE TEST    1 16 2 4 E   KR    CANCEL       The Circles display shows a series of small circles like the large circle   in the simple One circle display  Each small circle represents the SNR  recorded in a particular 1   2 octave frequency band when the minimum signal  level is met  If the minimum signal level is not met  the circle will not fill  completely  even if SNR criterion has been achieved  The numbers below  the circles indicate the kHz frequency of the centre of the 1   2 octave band     5 2 2 f    5 2 2 9    5 2 2 h    5 2 2 i    5 2 2     5 2 2 k    5 2 2 l    5 2 2 m    5 2 2 n    Otoport Lite   41  User Manual    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 good testing conditions  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 green if it is below   The noise level shown is calculated from the peak sound level recorded  within each response window     The letter below the indicator represents the noise reject threshold level   This can be altered using the up and down arrow keys     The noise level indicator allows continuous monitoring of the noise level  during a test     Test condi
52. e rub and  providing greater probe stability     12214 Using the cable clip    12 2 1 2 Push the plunger to open the cable grip        12 2 1  Place the probe cable in the slot and release the plunger  The position of  the clip on the cable can be adjusted if necessary        12 2 1 c Open the crocodile clothing clip        12 2 14 Attach the probe cable clip to the patient s clothing     l a   a  q  be  1  L       12 21 e If the cable slips through the grip  turn the head to grip the cable     122 14 Use a sterile wipe to clean the clip               vo  O            Q  O  O      5     6          ae  Q  2  O  ku  A       110   CHAPTER TWELVE  Probe  tips and accessories    12 3    12 3 a    12 3 1    Probe tips    Samples of either TEOAE or DPOAE tips are provided with your  instrument  Further supplies may be obtained from your distributor or from    Otodynamics     TEOAE tips    T3E   REF  A90 01 2 0    Fits  3mm ear canal  Small and premature  newborns    T5C   REF   A90 20 2 0    Fits  5mm ear canal  Newborns    T6 5B   REF  A90 04 2 0    Fits  6 5mm ear canal  Large newborns and  first year infants    TSM  A90 05 2 0    Fits  8mm ear canal  Infants and small  adult ears    T11M   REF  A90 07 2 0    Fits  11mm ear canal      Large adult ears       T4 5C   REF  A90 02 2 0    Fits  4 5mm ear canal  Small newborns    T5 5B   REF  A90 03 2 0    Fits  5 5mm ear canal  Most newborns    T7M  A90 24 2 0    Fits  7mm ear canal  Infants and children    TSM   REF  A90 06 2 0    Fit
53. ect Result when a patient is highlighted to inspect the patient   s saved  Test Results  A summary of each test will be shown     Select Back at any time to exit the Patient List screen and return to the  main menu     N  xo   i   0  0     x       64   CHAPTER SEVEN  Records    TAA Details    PATIENT DETAILS  W114  ID Notes OGPM2108  Name Hale  D O B 01 Feb 2012  Gender 4 Male b       BACK PRINT TEST    711 2 The Patient Details screen allows the user to see the ID Notes field   Name  Date of Birth  DOB  and Gender stored for a particular patient     7 11  Selecting Test from this screen starts a new test  the result of which will be  saved with the records of the selected patient     71 1 c Selecting the up and down arrow keys on the patient details screen  displays the patients before or after the current patient in the patient list   Selecting the left and right arrow screens displays the test results for the  selected patient     7 1 1 4 Select Back to return to the Patient list     7 1 2    7 1 2 a    7 1 2 b    TAZC    T1246    7 1 2 e       Otoport Lite   65  User Manual    Results      lt     TRAINING  REQUIRED    The test summary gives an overview of the test result including  2 octave  band passes and total OAE signal level  The diagrams following illustrate  the features of a test summary screen     The number of tests currently saved to the patient is displayed in the top  right of the screen     The up and down arrow indicators to the left of the screen show that
54. ect an appropriate tip  2 Fit the tip to the earpiece  3 Fit the earpiece in the ear  canal     1 To run a TEST  press the D 2 The size of the ear being 3 During the test the circle fills  button  l tested is indicated by the as OAEs are detected  TE  graphic  Press w to START  model only   Display depends  on test setup        Otoport Lite   19  User Manual    ENTER DETAILS    RHI M3NO00  Oliver  23 Mar 2012    SCAN SAVE  4 DP tests display a circle for 5 The test will auto stop with 6 Enter the patient details and  each frequency  the result shown  Select Save   Save with the   button     CONFIRM      J  RETEST PRINT FINISH    7 Select the ear tested with the 8 Select Save with the 9 After saving you have options  E   buttons  button  to Retest the patient  Print  i   the result or Finish the test     Step 4  Disconnecting the probe    1 Unscrew the knurled sleeve  2 Do NOT turn the main probe 3 Gently pull out the probe   body        N   Otodynamics Ltd   2 R  www otodynamics com hes  International   44  0 1707 267540 sos  Email  support otodynamics com or  z  OY        Q     an       e  u   3      Par     Q  9        20   CHAPTER TWO  Getting started    2 7    PATE    2 7 1 a    2 1 2    2   2 a    2 7 2 D    Using the keys and keypad    Control keys       The keys directly below the screen marked with a square  a diamond or a  circle enable you to execute the functions offered on the screens  Their  functions vary from screen to screen  but generally the right  circle  k
55. ed by absorption and reflection from structures  objects and people      a  Field strengths from fixed transmitters  such as base stations for radio  cellular cordless  telephones and land mobile  radios  amateur radio  AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy  To  assess the electromagnetic environment due to fixed RF transmitters  an electromagnetic site survey should be considered    If the measured field strength in the location in which the Otoport is used exceeds the applicable RF compliance level above   the Otoport should be observed to verify normal operation  If abnormal performance is observed  additional measures may be  necessary  such as re orienting or relocating the Otoport      b  Over the frequency range 150 kHz to 80 MHz  field strengths should be less than 3 V m     Otoport Lite   143  User Manual    Recommended separation distances between portable and mobile RF communications  equipment and the Otoport    The Otoport is intended for use in an electromagnetic environment in which radiated RF  disturbances are controlled  The user of the Otoport can help prevent electromagnetic  interference by maintaining a minimum distance between portable and mobile RF  communications equipment  transmitters  and the Otoport as recommended below  according  to the maximum output power of the communications equipment        Rated maximum Separation distance according to frequency  output power of of transmitter  m   trans
56. er that there is limited storage  capacity left     8 5 1 f    8 5 2    8 5 2 a    8 5 2 6    8 5 2 C    8 5 2 0    8 5 2 e    8 5 2 f    8 5 2 9    8 5 2 h    8 8 2 1    8 5 2     8 5 2 k    8 5 2 l    Otoport Lite   77  User Manual    If the Memory Status screen has been displayed because the Otoport  memory is full or nearly full  the user will also have the option to Download  data to a PC using Otolink     Controls    CONTROLS    2 Brightness    3 Backlight       Volume    Use the left and right arrow keys to decrease or increase the Volume level   To turn the sound off press the left arrow key repeatedly until Sound Off  appears in the centre of the display     Select Save to accept the new Volume level     Select Back to ignore changes and return to the Controls Menu     Brightness    The screen Brightness can be altered by pressing the left right arrow keys   Select Save to accept the adjusted Brightness level     Select Cancel to ignore changes and return to the Controls Menu     Backlight    Use the left and right arrow keys to toggle between the Backlight control  choices for the screen and keypad  The backlight can be configured to  be either always on or off  or on for a limited period of time  7  10  20 or  30 seconds  after a key press  Reduction in the backlight time will help to  preserve battery charge during operation     Select Save to accept the Backlight setting     Select Back to ignore changes and return to the Controls Menu     c     ad             5 
57. evel   This can be altered using the up and down arrow keys     The noise level indicator allows continuous monitoring of the noise level  during a test     Test condition information    When conditions are good for data collection DP TEST will be shown at the  top of the screen and progress indicators will move either side of the title to  show that a test is currently running     Test stop reasons    There are three possible ways in which a test can stop  AutoStop    Test Timeout and Manual End  When the test stops the data collected  is assessed and a result given as a pop up graphic and then written  highlighted at the top of the test screen  The Otoport will beep once if a  test has stopped with a DPOAE Pass result and will beep twice if the test  has stopped with any other result  AutoStop and Stopping  Pass  criteria  are configured in the test settings area  section 8 3      AutoStop    If the test data collected meets the set pass criteria then the test will  AutoStop and a large checkmark will be displayed     Test timeout    If a test has not met the set pass criteria then the test will stop after 60  seconds     Test    48    CHAPTER FIVE    Test    5 3 3 f    5 3 3 g    5 3 3 h    5 3 3 i    Manual end    Selecting End at any time will stop the test     Pausing and cancelling the test    CANCEL TEST        ka  CHECKFIT YES    You may wish to pause a test for instance during periods of noise  When  the test is paused  it is possible to cancel the test and discard 
58. ew N A   user administrator rights    Select No to restrict the user N A    to screener rights    8 6 1 c    8 6 1 d    8 6 1 e    8 6 1 f    8 6 2    8 6 2 a    8 6 2 b    8 6 2 c    8 6 2 d    8 6 2 e    8 6 2 f    8 6 2 g    8 6 2 h    Otoport Lite   83  User Manual    The User ID is added to a saved test record to identify the user who  performed 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  return to the New User screen where the User ID field will be selected for  editing     Selecting Save will add the user to the User List  The User List will  appear with the newly saved user highlighted on screen  The message  Cannot Save  Please enter Name and User ID may appear after  selecting Save if either of the two fields have been left unfilled     Select Cancel to cancel the addition of a New User and return to the  Users menu screen     A new user is given a choice of two levels of access rights  If Yes is  selected in the administrator field  then the user will have full access to  all the Config areas of the device  Select No to restrict the user   s rights  to only the Probe test area in Config  disabling access to higher level  functions     View Users    The User List displays the Name  Password and Status of all users  currently saved to the device     Select Back to exit the User List and return to the Users Menu
59. ey  provides affirmative options and the left  Square  key provides negative  options     Arrow  navigation  keys       The arrow  navigation  keys provide Left  Right  Up and Down control and  allow the user to move to options available on the screen  The selected  option becomes highlighted     The left and right arrow keys scroll through the main menu options     240    2 7 3 a    210 0    2 7 3 C    2 7 4    2   4 a    Otoport Lite   21    User Manual    Entering characters    ra    f         Character entry is similar to a mobile phone where numbered keys can be  pressed sequentially to select the required character     The order of the characters is dependent on context  For example when  used to enter     Patient ID  Numbers are presented first then capitals  e g  2ABC     Family Name   For the first character capitals are presented 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 to indicate that the string continues to the left or  the right Pressing the appropriate Arrow navigation keys will display the  hidden characters     Foreign character table       A foreign character pop up table can be accessed by holding down the 1  key for 1 5 sec  Use the Arrow keys to navigate around the table  Select  Insert to enter the required character or select Cancel to close the table  window         Q     ae      de  
60. g the  main probe body  smooth chrome section      Main probe  body       This will result in damage to the probe and will invalidate the  probe warranty     3 1    3 1 a       Otoport Lite   27  User Manual    switching On    Switch on screen    a       To switch on the Otoport press the green On Off power key found at the  bottom left of the keypad  The display screen will show Switch Unit On            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 device will automatically turn off  The unit will turn off if any key  other than Yes is selected  This is to prevent accidental switch on during  transit     28   CHAPTER THREE  Switching on    3 2    3 2 a    3 2 b    3 2 C    3 2 0       Logo screen    44 Jan 12    g    r  Li  T  T  T  I    Following switch on  an Otodynamics    logo animation is displayed whilst the  device performs a series of hardware system checks  In the unlikely event  of any of the systems checks failing  an error message will be displayed   see chapter 16 5 Hardware fault messages for details      A battery graphic will appear to the right of the logo to provide an indication  of the Battery Power remaining  Please refer to chapter 15 Otoport Power  for battery information     The date and time are also shown at the top of the screen and can be reset  if necessary via the Configuration menu  see chapter 8      Selecti
61. hen the  lid  fig  1   Remove the coupler tubes by pushing the end of the tubes  down onto a hard surface  fig  2   Pull out the tubes by gripping them  fig   3   Never remove them by pulling on the cable  Finally  pull the coupler  tubes away from the probe  fig  4              H       Lay  Po BY    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  fit a new tip  fig  4          SEs             14  14        wd     i     ll  oly    Notes     e Fit a new tip for each test     e Check that the coupler tubes are not contaminated before  fitting the tip     e Ifthe coupler tubes are contaminated  replace them  We  recommend fitting new coupler tubes at regular intervals   approx every 20 40 tests  as a preventive measure     e Perform weekly probe QA tests  see chapter 11 Probe tests      13 3    13 3 a    13 3 b    13 3 C    Otoport Lite   115  User Manual    Probes safety note    Probes are designed for use with an Otodynamics disposable tip  Use of a  tip is essential     Use without a tip will expose the ear canal to the hard plastic sound tubes  and this might cause injury     Use without a tip or with an incorrect or non Otodynamics tip may also  Cause serious errors in measurement  This could invalidate the OAE  recording        Probe care    116   CHAPTER FOURTEEN  Care of the Otoport    14    14 0 a    
62. hen the Otoport has  reached this level of charge  The Otoport should be charged as soon as  convenient     15 4 3 Auto switch off    15 4 3 a The Otoport will automatically switch off when the battery is empty  It will  be necessary to charge the Otoport before it will switch on again     hn  O   gt   O   3  wo  tan  O  2   O  ae  O       122   CHAPTER FIFTEEN  Otoport power    15 5    15 5 a    15 5 b    15 5 c    15 521    15 5 1 a    15 5 1 b    15 5 1       Charging the Otoport   lt   gt     TRAINING  REQUIRED       Observe the on screen battery indicators to determine when to charge your  Otoport  In general it is advisable to charge the Otoport batteries when the  indicator is empty  showing less than 10  charge  However  the batteries  should be at least 30  charged if a full day   s testing is planned     It is recommended to charge the Otoport using the charger supplied  but  it is also possible to charge the device using the PC cable connected to a  PC     Note     Do not charge more than one Otoport on the same PC at any  one time     Connecting the Otoport for charging  Switch off the Otoport prior to charging     Connect the mains lead to the charger and 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 the Otoport  Ensure the arrow is   facing upwards    cee   r ay j  F   o gt    2    h oy          Otoport Lite   123  User Man
63. ic low voltage  power supply network that supplies  buildings used for domestic purposes  Harmonic emissions   Class A   IEC 61000 3 2       Voltage fluctuations    Complies  flicker emissions  IEC 61000 3 3    The Otoport should not be used adjacent to or stacked with other equipment and  that if adjacent or stacked use is necessary the Otoport should be observed to verify  normal operation in the configuration in which it is used     N  S  c  eel  G  0     0  Q  Q        G   lt   S  oan  Q  Q          140    CHAPTER TWENTY ONE  Technical specifications    Guidance and manufacturer   s declaration     electromagnetic immunity    The Otoport is intended for use in the electromagnetic environment specified below   The user of the Otoport should ensure that it is used in such an environment     Immunity test   IEC 60601 Compliance  test level level    Electrostatic   6 kV contact   6kV contact  discharge  ESD      8 kV air  8 kV air  IEC 61000 4 2  Electrical fast   2 kV for power     2kV for power  transient burst supply lines supply lines    IEC 61000 4 4    1 kV forinput     1kV for input   output lines output lines    Surge   1 kV line s  to     1kV differential  line s  mode    IEC 61000 4 5    2kVline s to     2kKV common    earth mode  Voltage dips   lt 5  Ut  lt 5  Ur  short interrup    gt 95  dip in Ut      gt 95  dip in U7   tions and voltage   for 0 5 cycle for 0 5 cycle  variations on  power supply 40  Ur 40  Ur  input lines  60  dip in Ut     60  dip in Ur     for 
64. ications    21 1 5  21 1 6  21 17  21 1 8  21 1 9    Clock Calendar    Internal Real Time Clock Calendar operates to 2099    Power    Li Polymer Battery   Intelligent multi level power control for charging testing idle sleep shutdown   After 1 5 minutes unit will enter sleep mode   After 20 minutes in sleep mode unit will shut down    Sleep time  20 hours minimum  with fully charged battery   Running time  6 hours minimum  continuous data collection   Battery voltage    operating range  3 4 2V  Max consumption   when testing  720mW  Max consumption   when charging  2 5W  Source  1000mAh lithium polymer internal rechargeable cells  Charge time  3 hours to 90  capacity   Approximately 4 hours to 100     Hardware Options    Bluetooth wireless printing  Barcode scanner  RFID reader    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    Analogue performance    Output channels  2 x 16bit resolution  Input channels  1 x 16bit resolution  Sample rate  Variable    Frequency response  Electrical     160Hz to 12KHz    2110 Environmental  X 7    N    Otoport Lite   137  User Manual    a N Protect from heat and radioactive sources          Keep dry          Transport and storage     Pressure     Humidity        Qs    Warm up time     Operating      fe  oS    Humidity     Temperature range     Temperature range     0 to 40 Celsius    23KPa to 101K
65. indication of canal  size can only be used as an approximate guide to probe fit     Otoport Lite   37  User Manual    5 1 1 j If the position of the Fit Size Indicator corresponds with the age of the  patient and Checkfit is displayed on the top of the screen then the probe  fit and the test conditions are adequate for testing  The Stimulus and Noise  OK indicators  above the screen  should also be illuminated  Select Start  to continue the test     511k If there is a disagreement between the Fit Size Indicator and the ear  canal size expected of your patient  then there may be a problem with the  probe or the probe fit  For example  an indication of a large ear canal in a  neonate may occur if the probe has fallen out of the ear or if the probe is  blocked  an indication of a small ear canal in an adult may occur because  of wax blocking the canal     5 1 1 1 Noise Level Indicator    5 1 1    A Noise Level Indicator is shown on the right of the Checkfit screen  The  red green bar moves in response to changes in noise  For good testing  conditions the bar should be green and remain consistently below the  Noise Reject Level  which is represented by the horizontal line across the  Noise Level Indicator  In poor testing conditions  when the noise level is  above the Noise Reject level  the bar will be red     51 1 n The letter below the indicator represents the noise reject threshold level   This can be altered using the up and down arrow keys     5 11 0 Generally higher noise 
66. ist    M    7 0 a  7 0 b  7 0 c    7 0 d    Records    Records       The Records section allows the user to see the Results of previous tests  and to view the Details of patients previously tested     Records may be via from the Memory Status screen accessed from the  Configuration area  see chapter 8      Records also allows the user to select a previously tested patient for a new  test     Selecting Records from the Main Menu takes the user to the Patient List  screen     7 1    7 1 a    7 1 b    7 1 c    7 1 d    7 1 e    7 1 f    Otoport Lite   63  User Manual    Patient list    PATIENT wit  NAME ID NOTES     OGPM2108  OGPM2107    OGPM2106    OGPM2105  OGPM2103    DETAIL RESULT       The Patient list displays the ID Notes field and Name of each patient   The up and Down arrow indicators to the left of the Patient List show that  there are other Patient Records not currently visible on screen  At the  top of the screen  the total number of patients in the list and the position of  the current patient in the list are displayed  12 34 indicates that the current  patient is twelfth in a list of 34 patients     Use the up and down arrow keys to scroll through the list one Patient  Record at a time  A selected patient will be shown as highlighted in the list     Use the left and right arrow keys to skip through the Patient List   5  records at a time     Select Detail to review the complete Patient Details of the highlighted  patient or to run a new test on this patient     Sel
67. l test   Testing should only be conducted in rooms where the noise level recording  on the Otoport is mainly below the noise reject level when the probe is not  fitted in the ear  Some intermittent noise can be tolerated  but constant  high noise will inhibit successful recordings     OAEs and screening       OAE testing is commonly used as the primary hearing screen in newborns  with no known hearing loss risk factors  Failure to show a strong OAE  indicates that further testing or observation is necessary     OAE testing is frequently used as the initial screen within the    at risk     population  Passing the OAE test indicates that normal middle ear and  cochlear function is present  The specific risks must be evaluated to  determine whether ABR  auditory brainstem response  testing is necessary   even after a pass at OAE  Certain clinical conditions indicate the possibility  of retro cochlear neurological disorders which the OAE test cannot detect     Otoport Lite   35  User Manual    TRAINING  REQUIRED    LAST TEST LAST    WORK LIST   PATIENT DETAILS  WA  ID Notes OGPM1VO00  Name Brown  D O B 05 Jan 2012  4 Female       BACK PRINT TEST    5 0 a A Test may be started by selecting Test or Last from the main menu  screen  from the Worklist or by selecting Test from the Patient details  screen  in the Records area    5 0 b    You will not be able to start a test if the Otoport is connected to a PC or  power supply     Test    36   CHAPTER FIVE    Test  5 1  5 1 1  5 1 1 a  
68. luetooth  wireless technology  optional  or with a custom printer cable     86   CHAPTER NINE  Printing    a2 When you can print    9 2 a The Otoport provides flexible options to print from various areas of the user  interface  including printing at the end of the test     9 2 b Print settings are located under Configuration in System  Setup     CONFIGURATION SYSTEM    1 Probe Tesi 1 Memory Status    2 Test Settings 2 Controls   3 Date  amp  Time 3 Battery   4 System 4 Setup   5 Users 5 System Info    SELECT    SETUP                      Manual  Test  Detailed       9 2 1    9 2 1 a    9 2 2    9 2 2 a    9 2 3    9 2 3 a    9 2 3 b    Otoport Lite   87  User Manual    Printing at the end of a test       D  PRINT FINISH    When the OAE recording is finished and the result has been saved  select  Print for a printout of the patient details and test results  see chapter  8 5 4 9      Automatic print on save    For efficiency  you can configure the Otoport to automatically print when  the test is saved  see 8 5 4 Setup for details   The test is saved and a print  initiated with one key push  rather than starting the printout separately     Printing from records    PATIENT DETAILS  Wit  ID Notes OGPM 2108  Name Hale  D O B 01 Feb 2012  Gender 4 Wale I       BACK PRINT TEST    Results can be printed from the Otoport Records area  Select the patient  for which you would like to print results  see the Records section for details  of how to retrieve specific records from the database
69. ment cover     9 8 d Push down  and slide back the  battery compartment cover  2      9 8    Remove the old battery pack  and disconnect the battery pack  connector  noting its orientation     9 8 f Fit the battery pack connector  3   taking care to insert it correctly     9 8 g Fit the battery pack ensuring  wires  4  are not trapped     9 8 h Slide back the battery  compartment cover and replace  the screw     Important Note     Only charge the printer if it contains an approved battery pack   supplied by your dealer or Otodynamics Ltd     10    10 1    10 1 a    10 1 b    10 2  10 2 a    10 2 1    10 2 1 a    10 2 1 b    Otoport Lite 95  User Manual    scanning    Scanning facility    As well as the standard data entry method  using the keypad  the Otoport provides   two optional methods for data entry using  scanners  The scanning methods are  designed to reduce testing session times by  making the patient data entry method efficient        The scanners can also be used as part of the device security system during  login  Each operator can be assigned a login card  which the Otoport will  scan and verify in order to provide access to the machine     Scanner types    The Otoport has two scanning methods available     Barcode scanning    This method will scan barcodes which as standard hold numerical data   In screening programs which use barcode identification for patient ID  the  Otoport can be used to scan this number quickly into the device     To scan with the barcode 
70. message 127   FFT frequency bin 134   Fit Size Indicator 37  Foreign Character Table 21  Frequency ratio 134    Otoport Lite   149  User Manual    G    Good Stimulus 15    Hard reset 23  Hardware Options 136  Hardware processing and storage 136    Initial charge 118  Interfaces 135    K    Keypad 20  135    L    Language 80  LEDs 23  Lock up 126  Login 29   Logo 28   Low Battery 121    150   CHAPTER TWENTY TWO    Index    Main menu 30   Manual end 42  48  Manufacturer details 16  Maximum NLo Sweeps 42  Memory capacity 133  134  Memory status 76  77  Menu selection buttons 15  Microphone input filter 133  Mode  DPOAE  71   Mode  TEOAE  70   Model 16    Neonate setting 72   NLo sweeps 42   No Clear Response 44  49  Noise Level Indicator 37  41  47  Noise OK LED 23   Noise rejection calculation 134  Noisy 37  103   NReject 72    O    Occlusion test 106  On Off power button 15  On connect 80   One circle 40   Options 8   Otocheck lock up 126    P    Paper 92   Pass 102   Password 29   Patient list 63   Pausing the test 43  48  Poor Probe Fit 44  49  Power 118  136  Precautions 9   Printer 14   Printer battery 94  Printer fault detection 91  Printer light summary 91  Printing 85   Probe 24   Probe cable clip 109  Probe care 113   Probe checks 99  Probe fit 32   Probe socket 15  Probes safety 115  Probe test 100   Probe tips 110    Q    Query 103  Quickstart 17    Real ear test 107   Records 62   Response buffer averaging 132  Response frequency bands 133  Response frequency range 
71. mitter  W   150 kHz to 80 MHz to 800 MHz to  80 MHz 800 MHz 2 5 GHz  d  1 2V P d  1 2VP d 2 3VP  0 01 0 23  0 1 0 38 0 38 0 73    For transmitters rated at a maximum output power not listed above  the recommended  separation distance d in metres  m  can be estimated using the equation applicable to the  frequency of the transmitter  where P is the maximum output power rating of the transmitter in  watts  W  according to the transmitter manufacturer     Notes     1 At 80 MHz and 800 MHz  the separation distance for the higher  frequency range applies     2 These guidelines may not apply in all situations  Electromagnetic  propagation is affected by absorption and reflection from structures   objects and people     The Otoport can be optionally configured with either both Bluetooth and RFID functions   The frequency bands for reception and transmission of RF energy for these functions are as  follows      a  Bluetooth     2 4GHz to 2 4835GHz   b  RFID     13 56MHz    The Bluetooth and RFID functions of the Otoport may be interfered with by other equipment   even if that equipment complies with CISPR emission requirements     N  S  c  q  G  0     0  Q  Q        G   lt   S  oan  Q  Q          144   CHAPTER TWENTY ONE  Technical specifications    21 3    EN60645 3 conformance notes    These notes are provided in compliance with EN60645 3    Electroacoustics  audiometric equipment   Part 3  test signals of short duration         a  Types of short duration stimuli     The Otoport TE
72. n  The noise level for noise reject is calculated from  the difference between consecutive 80ms samples     Stimulus frequencies  F2   Sine waves of 6  4  3 and 2 kHz    Frequency ratio    F2   1 22 F1  Memory capacity  Patients 500  Tests per patient 256    Total tests 500    Otoport Lite 135  User Manual    24 Technical specifications    11 General    Note     The Otoport has no user serviceable parts  Any required  servicing must be conducted by Otodynamics Ltd or authorised  service facilities only    21 1 1 Physical    Hand held device  197mm x 70mm max  x 30mm  Weight 0 55lbs  250g   Charger  90mm x 38mm x 28mm     Weight 120g    2142 Interfaces    Probe connector compatible with Otodynamics UGx probes  8 pin    Charging Data connector   connects to Otodynamics PSU  charging  or to PC USB  port  USB 1 10r 2 0  via Data Cable   Bluetooth wireless print  option    RFID reader  option     21413 Indicators    Data Display  Resolution  QVGA  320 x 240 pixels   166 dpi  Technology  Colour LCD  16 bit  displaying 65K colours   Viewable Area  46 5mm x 36 5mm    Backlight  White   intelligent control  Probe fit  Noise OK  Blue LED     N      Stimulus OK  Blue LED     S      Power Charge  Power OK  Green LED  Fast charge  Amber LED  Audible  Wide range speaker provides audio feedback of status    21 1 4 Keypad    19 key alphanumeric with cursor control and soft keys    N  S     eel  G  0     0  Q  Q        G   lt   g  one  Q  Q          136    CHAPTER TWENTY ONE  Technical specif
73. ng Config during start up takes the user to the Configuration menu  where probe test  test settings  date  time  system details and users may  be viewed or edited  see chapter 8 Configuration      3 9    3 3 a    3 3 b    3 3 c    3 3 d    3 3 e    Otoport Lite   29  User Manual       SCAN LOGIN    If Login is on  see chapter 8 6  the login screen will be displayed and the  user will be required to enter a name and password     Use the left and right arrow keys to choose the correct user name from the  choice bar     After 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 Password field  To review charcters that have been  entered  simply scroll back through the   using the left and right arrow keys     When the User and Password have been chosen  select Login to access  the device  If the Password has been entered incorrectly  then a warning  message will appear as below     incorect Login  Password     x       30   CHAPTER THREE    Switching on  3 Main menu  3 4 4 You are then presented with the main menu screen  From here you can  view the Result of the last test  select the Last patient tested or perform  a Test  The heading on the screen indicates whether the Otoport is a  TEOAE or DPOAE model     3 4 b       LAST TEST RESULT LAST    TEOAE model DPOAE Model    Use the left and right arrows to access Records and the W
74. nual    The Configuration menu can be accessed by selecting Config on the logo    screen after switching on     Select Probe Test to check the calibration performance of a probe     Select Test Settings to change test display and pass criteria     Select Date  amp  Time to set the current date and time   Select System for memory  battery and system information     Select Users for login options     Note     Users without Admin rights will only have access to Probe Test     The other items will be hidden     Probe test    Details of how to perform a probe test are in chapter 11 Probe checks     c     ad             5   D   m   S   o   Oo       68   CHAPTER EIGHT  Configuration    8 3    8 3 a    8 3 b    8 3 c    8 3 1    8 3 1 a    8 3 1 6    8 3 1 C    8 3 1 d    Test settings    TEST SETTINGS    Display i   Circles     Mode  Any3Bands  gt     Neonate 4 Off b  Nreject 4 Variable      T    CANCEL SAVE       Use the arrow keys to navigate and choose between the setup options   described below      Select Save to apply the settings changes you have made and return to the  Configuration screen     Select Cancel to discard changes made to date and time settings and  return to the Configuration screen     Display  TEOAE     TE TEST       If One circle is selected  a single circle display is shown     An empty circle means that OAE data has not yet been recorded  The  circle fills from the bottom  indicating good quality OAE data is being  collected     As the circle fills  this in
75. o respond to user control  hold  the On Off key down for 10 seconds  in order to reset the device  You may  then switch on the device as normal         Q     ae      de  7   3      Par     ov           24   CHAPTER TWO  Getting started    2 8    2 8 a    2 8 b    2 8 C    2 6 0    Connecting the probe         TRAINING  REQUIRED       Prior to the testing session  connect the probe to the Otoport     The probe plug contains a    key    that must be aligned with the    keyway    in  the probe socket on the Otoport     Probe key Socket keyway       The arrow at the front of the probe plug indicates the position of the    key     and should be aligned with the front of the Otoport     Arrow       It is possible to feel when the probe key is aligned as the probe will mate  with the socket easily     Align arrow with  front of Otoport       2 8 e    2 8 f    2 9    2 9 a    Otoport Lite   25  User Manual    Push the probe into the socket until it hits the end stop  DO NOT force in  the probe        Probe in socket    Turn knurled  sleeve clockwise    Disconnecting the probe    To disconnect the probe  unscrew the knurled sleeve in an anticlockwise  direction until the thread is disengaged     Turn knurled  sleeve  anti clockwise           Q     ae      de  7   3      Je     ov           26   CHAPTER TWO  Getting started    2 9 b Then gently pull the probe out from the probe socket     Remove probe       2 9 c Important Note     Do NOT attempt to screw or unscrew the probe by holdin
76. of clicks into the ear and records  the response  The OAE signal is very small and difficult to distinguish from  the noise made by other sounds in the room and by the patient  The longer  the Otoport records for  the easier it is to distinguish the OAE signal from  the noise  The Otoport looks at the ratio of the OAE signal to the noise   this is known as the Signal to Noise Ratio or SNR  The Otoport measures  the SNR in a number of different frequency bands  The pass criteria is set  in the Configuration area  see chapter 8 Configuration   The default pass  criteria is an SNR of 6dB and a minimum signal of  gt  5dBSPL in at least two  frequency bands     It is the responsibility of the user to ensure that the pass criteria set meet  their requirements     5 2 1    5 2 1 a    5 2 1 b    5 2 1 c    5 2 1 d    Otoport Lite   39  User Manual    Stimulus adjustment    ADJUSTING          When START is selected  the Otoport will attempt to adjust the stimulus  level to the required level  The message Adjusting    is displayed while  this is happening  Once the correct level has been reached  by default the  Otoport automatically begins the test     The Otoport may not be able to adjust the stimulus to the correct level   in noisy environments  if the probe fit is poor or if the patient   s ear canal   is unusually large  If the correct stimulus level is not reached after 10  seconds then the message Stim out of range will be displayed  The user  then has the option to Continue or 
77. only   a large checkmark is  displayed to indicate a pass          H  RETEST PRINT FINISH    If the display is set to Circles  full circles appear with a checkmark in each  band that met pass criteria     FEQAE PASS    0000e    ees F  e A   KHE       M  RETEST PRINT FINISH    Note     If the SNR criteria are met but not the minimum signal criteria   see chapter 8 Configuration  a full circle will be displayed  without a checkmark     The user may Save or Cancel the result from the Review screen  at the  end of review      5 6    5 6 a    5 6 b    5 6 c    5 6 d    5 6 e    5 6 f    5 6 g    5 6 h    Otoport Lite   53    User Manual    Save    ENTER DETAILS    ID Notes OGPM1V00    dd Mmm yyyy  Gender    NotGiven      CANCEL RECORDS SAVE       The Enter details screen is shown  The patient ID is filled with an  automatically generated ID  The Name field displays Auto  The user may  either save these details or overwrite them with alternative patient s details   If an ID is not required  this field may be used as a notes field     A Date of Birth  D O B  and Gender may also be added for the patient     A further 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     Only one Facility can be stored on the Otoport  It is not  possible to store different facilities for different patients  If you  wish to change the Facility  download and erase all test records  from the O
78. or    Noise OK indicator    Refer to operating instructions    Training required    Otoport Lite   147  User Manual    148   CHAPTER TWENTY TWO    Index    22 Index    A    Accessories 14   Adjusting    39   Analogue performance 136  Arrow  navigation  buttons 20  AutoStop 42  47   Auto switch off 121    Backlight 23  Barcode RFID scanner 16  Barcode scanning 95  Battery 28  78  118  120  Beep 42  47   BGS 108   Blue LEDs 23   Body  amp  Lid 108  Brightness 77   Buttons 20    C    Calendar 136   Cancelling the test 43  48   Case 14   Cavity test 105   Certification 16   Changing probe coupler tubes 113  Charger and PC cable socket 15  Charging status indicators 15  Charging the Otoport 122  Charging the printer 93   Checkfit 36   Checkfit stimulus 134   Check probe fit 37   Choice bars 22   Circle 40   Circles 40   Cleaning 113  116   Clear Response 44   Clock 136   Conditioning the Otoport battery 125  Connecting the probe 24  Control buttons 20   Coupler assembly 113   Coupler tubes 108  113   Critical battery 121    Data entry keypad 15  Data summary screen 41  Date 28   Date and time 75  Deleting characters 23  Details 104  Disconnecting the probe 25  Dismantling the probe 114  Display 15   Display  DPOAE  69  Display  TEOAE  68  Docking station 14   DP Noise calculation 134  DP Stims  DP only  73   DP stimulus calibration 45  DP Test 45    Ear canal size 36   Edit User 83   Entering Characters 21  Entering Dates 22  Environmental 137  Extend 73    j     Fail 102   Fault 
79. ork List  See  chapters 6 and 7 for further details     Records   WORK LIST       4 1    4 1 a    4 1 b    4 1 c    4 1 d    4 1 e    4 1 f    4 2    4 2 a    Otoport Lite   31  User Manual    Test preparation    s    TRAINING       REQUIRED      General checks before testing    Ensure the Otoport is charged  see chapter 15 Otoport power for  information      Ensure the Otoport weekly checks are being regularly conducted  see  chapter 11 Probe checks for information      Do not run an OAE test if there is any 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     Connecting the probe    Prior to the testing session  connect the probe to the Otoport        S     al        tee       a   G   du   em  del   O          32   CHAPTER FOUR  Test preparation    4 3    4 3 a    4 3 1    4 3 1 a    4 3 1 b    4 3 1 c    4 3 1 d    Tip selection and probe fitting    Appropriate tip selection and good probe fit are essential to ensure  successful OAE recordings  A good probe fit will help to block out external  noise and enhance the OAE signal  The Otoport is supplied with a full  range of tips to fit all ear canal sizes  When selecting a tip  first inspect  the ear to be tested to assess 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 
80. ost     Over time batteries will wear and lose their capacity  resulting in  quicker discharge  The batteries may therefore need replacing  around every 4 years of use     Otoport power    120   CHAPTER FIFTEEN  Otoport power    4 Battery charge       15 4 a When the Otoport is switched on  the opening screen shows a battery  indicator which displays the remaining level of battery charge     15 4 b The indicator has 5 segments which convey the total Battery Charge  remaining  The battery segments are shaded according to the following  criteria     Segments Displayed Battery Power      95   100  75   94  55   74  40   54  30   39  20   29  1 10   19  0  lt  10    NIO BR  aI OJIN    Otoport Lite   121  User Manual    15 4 1 Low battery    LOW BATTERY     Please charge unit        15 4 1 2 When the battery power reaches less than 10  remaining a Low Battery  warning message will be displayed  This equates to approximately 30  minutes of testing time  Select OK to accept the message and return to the  previous screen  This screen will continue to appear every minute  as a  reminder to charge the battery     1542 Critical battery    A      CRITICAL BATTERY   Charge Otoport    before starting a new  test        15 4 2 2 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 message and return to the previous  screen  It will not be possible to start a new test w
81. our patient records        9 7    9 7 a    9 7 b    9 7 C    9 7 d    Otoport Lite   93  User Manual    Charging the printer    s    TRAINING  REQUIRED       To charge the printer  plug the charger into a mains outlet socket and insert  the charger jack plug into the rear of the printer  The light on the printer will  flash green orange to show the printer is on charge  The red charger light  will also illuminate  A full charge will take approximately 15 hours     ie          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 print several  rolls of paper  The printer light will flash green red when the batteries are  low     Note     The printer charger is not medically approved  The Otoport must  not be in patient contact if connected to the printer whilst the  printer is charging     94   CHAPTER NINE    Printing    9 8    9 8 a    9 8 b    9 8 c       9 8 i       Changing the battery    Ss    TRAINING  REQUIRED    The printer battery will   provide up to 500 charge and  discharge cycles  If the battery  performance deteriorates   the batteries will need to be  changed  A spare battery  cradle  which takes 4 AAA  batteries  is provided with the  printer  Alternatively a new  battery pack can be obtained from your dealer or Otodynamics        To change the battery pack     Remove the screw  1  from the battery compart
82. probe body and lid    Charger and mains lead or charging cradle             PC cable for downloading patient and test data to PC    ET    Sample probe tips in compartmented box          sij    2k    2s lal    Otoport Lite   13  User Manual    Otolink software CD       T    pa a  e aie a att  iy  r    Infection control sleeve   transparent  easy clean cover for optional use  with Otoport  shown fitted below right        Documentation pack   including instrument and software manuals   Quickstart and probe use guides        Q     ae      de  7   3      Par     ov           14   CHAPTER TWO  Getting started    2 2    2 2 a    2 2 b    2 2 6    220    Optional accessories    A range of additional accessories are available from your distributor or from  Otodynamics     Otoport docking station   a stable base to hold the Otoport  with  connections for printing  charging and downloading to PC  shown with  Otoport below right        Otoport printer   a small  portable printer for wired or optional wireless  connection       is gm  ae i F p     aT       Large Otoport case  with additional compartment for printer  shown below  left with Otoport kit including printer        Otoport Lite   15  User Manual    m Controls  indicators and connections    Probe socket 9          _____           a       Stimulus OK  S   and Noise OK  N     and Otodynamics  indicators       Display screen    Menu selection  keys    Up down left right  navigation keys    Data entry keypad    On Off power key    Ch
83. r canal  The presence of  fluid and debris in the ear canal or middle ear will also inhibit recordings     If a pass result is not obtained  remove the probe and inspect the probe tip   Discard the tip if it has collected debris or moisture  Also check that the  probe coupler tubes are clear and replace these if a blockage is noticed   Then refit the probe and try again  Problems of debris and middle ear   fluid occur mostly in babies younger than 6 hours and are often cleared   by feeding or turning the baby  If there is no success during the first OAE  testing attempts  a second OAE testing session usually brings success  when the ear has had time to clear     S     we        tee       a   G   du   em  del   O          34    CHAPTER FOUR  Test preparation    4 4 c    4 4 d    4 5    4 5 a    4 5 b    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 one month may be  too active to test  When testing a child it can help to entertain them during  the test  so they don t become too restless  Try to keep the probe cable out  of their reach  using the probe cable clip may help  Instruct adults to be still  and remain quiet     Noises from the patient may not prevent successful recording  but will  increase the test time  Constant environmental background noise  for  example from air conditioning or machinery  may prevent a successfu
84. r 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 by either a charger or PC  the Otoport is powered from the  attached device and not its internal batteries     When connected to a charger it is possible to switch on and control the  Otoport but it is not possible to run a test     When connected to a PC it is not possible to control the Otoport  If the  Otoport is on when it is connected to a PC the current screen displayed will  remain until the device is unplugged again     Disconnecting the Otoport    When the charging cable is disconnected  the power light will extinguish  on the Otoport and if the Otoport was off prior to the charging session  the  screen will return to blank  If on during the charging session the current  screen will remain displayed     Otoport Lite   125  User Manual    se Conditioning the Otoport battery    15 6 a In order to maintain the Otoport battery and keep it at optimal performance  you should condition the battery once per year  or if the unit   s battery  appears to run down more quickly than expected  This process involves  completely discharging the battery  using a function provided in the  Otoport System area and then fully charging the device  see chapter 8  Configuration      15 6 b The condition utility is available from the Configuration menu by selecting  System then Battery  Selecting Condition and confi
85. reen     Select Cancel to discard changes made to date and time settings and  return to the Configuration screen     Important Note     Do not set the date on the Otoport to an earlier date  if there is  data stored on the device     c     ad             5   D   m   S   o   Oo       76   CHAPTER EIGHT  Configuration    8 5    8 5 a    8 5 1    8 5 1 a    8 5 1 b    8 5 1 c    8 5 1 d    8 5 1 e    system    SYSTEM    1 Memory Status  2 Controls   2 Battery   4 Setup   5 System Info    SELECT       The System screen allows users to view information on Memory Status   Controls  Battery power  System Information or to change the Setup     Memory status    MEMORY STATUS    Test Mermory    T Fe   i Si    97  Free Memory    BACK ERASE       The Otoport has the capacity to store up to 500 test records  The memory  status screen displays the number of records currently stored and the  percentage memory still available     Selecting Erase deletes all test records from the Otoport after requesting  confirmation from the user  A screen confirming the Erase is then  displayed and the user is returned to the main menu     If there is less than 10  free memory then the Memory Status screen will  be displayed at start up     If there is 0  free memory then the Memory Status screen will be  displayed automatically and no further tests may be performed until tests  have been erased     The Memory Status screen will be displayed immediately after the 450th  result has been saved warning the us
86. reject can give faster data collection but poorer  quality data  The best noise reject setting depends on both test conditions  and the strength of the emission being tested  Strong emissions may be  detected in a noisy environment with a high noise reject threshold  Weak  emissions may only be detected in a quiet environment with a low noise  reject threshold     51 1     Checkfit condition information    5 3 1 q When conditions are good for data collection TE TEST  or DP TEST  will  be shown at the top of the screen and progress indicators will move either  side of the title to show that a test is currently running     5 4 1 1 Check Probe Fit is shown if the stimulus level falls outside the accepted  range     5 1 1  Noisy appears if the noise level is consistently above the Noise Reject  Level for a period of time     5 1 1  Ringing is displayed when there is obvious oscillation within the Stimulus  Waveform after the initial expected positive and negative peaks     38    CHAPTER FIVE    Test    5 1 1 u    5 2    5 2 a    5 2 b    The following table describes what Highlighted Message will appear if  more than one condition is met     Consistent Stimulus Out Stimulus Highlighted  High Noise of Range Ringing Message   No No No Checkfit   Yes No No Noisy   No Yes No Check Probe Fit  No No Yes Ringing   Yes Yes No Check Probe Fit  Yes No Yes Ringing   No Yes Yes Check Probe Fit  Yes Yes Yes Check Probe Fit    TE test  TEOAE model     During testing the Otoport plays a series 
87. rge your Otoport with the charger  charging cradle  or  docking station supplied by Otodynamics    Battery life    The Otoport is powered using an internal rechargeable battery  The battery  will provide enough power for over 250 tests from a single charge  With  built in power save functions and by switching the device off for the periods  between tests  the battery will provide enough power for over a week   s  intensive use     Initial charge    The Otoport is fully charged before it leaves the Otodynamics factory   However  the battery will discharge slowly  even if the device is switched  off  Itis therefore recommended that an initial charge is provided to fully  charge the battery before using your Otoport for the first time     15 3    15 3 a    15 3 b    15 3 c    15 3 d    15 3 e    Otoport Lite   119  User Manual    Standby    To save power  the Otoport will go into standby mode after 3 minutes of  inactivity  The standby screen will be displayed     The Otoport will not go into standby if a test is being performed     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 standby it will turn off  An audible  beep will be emitted from the device for a period of 10 seconds to alert the  user prior to the automatic shut down     Notes     Following an OAE recording  always save test data  as data that  has not been saved prior to auto switch off will be l
88. rming will set the  device to full power to drain the battery     SYSTEM    1 Memory Status  2 Controls    3 Battery    4 Setup  5 System Info    SELECT       15 6 c This process can take up to 6 hours  Select Cancel to stop the  conditioning process  The Otoport will automatically switch off when  the battery has been fully discharged  Now fully charge the Otoport to  complete the battery condition cycle  Wait for the tick on the screen and for  the charge light to extinguish  to confirm a full charge     BATTERY DISCHARGE BATTERY     Charge 95   7 Charge 80   7    Time 369 min E   Time 551 min  Health oo   I Health 99    voltage 41V I Voltage 40      BACK CONDITION NO       1561 Additional battery care    15 6 1 a If the Otoport is not in regular use  in order to maintain the battery  fully  charge the device every two months     hn  O   gt   O   3  we  tan  O  2   O  ae  O       126   CHAPTER SIXTEEN  Troubleshooting    16    16 1    16 1 a    16 2    16 2 a    16 3    16 3 a    16 3 b    16 3 c    Troubleshooting    Otoport lock up    In the unlikely event of an Otoport lock up and it is not possible to control  the device  turn the unit off and switch it on again  If this is not possible   hold down the on off power key for 10 seconds  this will force the unit to  switch off  Turn on the Otoport again     Switch on    During switch on  the Otoport conducts a series of system checks  If the  Otoport will not switch on and complete its start up sequence  check that  it is 
89. s  9mm ear canal  Most adult ears    T13M  A90 18 2 0    Fits  13mm ear canal  Extra large adult ears    DPOAE TEOAE tips    R4 8S  A90 08 2 0    Fits  4 8mm ear canal  Small newborns    R6 8B  A90 17 2 0    Fits  6 8mm ear canal  Large newborns and  first year infants    R8M  A90 09 2 0    Fits  8mm ear canal  Infants and small  adult ears    R11M  _  REF   A90 11 2 0  Fits  11mm ear canal  Large adult ears       Otoport Lite   111  User Manual    R5 8B   REF   A90 16 2 0    Fits  5 8mm ear canal  Most newborns    R7M  A90 25 2 0    Fits  7mm ear canal  Infants and children    ROM  A90 10 2 0    Fits  9mm ear canal  Most adult ears    R13M  A90 19 2 0    Fits  13mm ear canal  Extra large adult ears         2  vo  O            Q  O  O      5  z  6          ae  Q  2  O  ku  A       112   CHAPTER TWELVE  Probe  tips and accessories    12 3 3    12 3 3 a    12 3 3 b    12 3 3 C    12 3 3 d    Use of tips      Ss    TRAINING  REQUIRED       All Otodynamics probe tips are disposable and MUST be discarded after  each test  The probe coupler tubes should be visually examined for signs  of contamination and the outer parts cleaned with an antiseptic wipe  Take  care not to squeeze any cleaning fluid into the tubes     The TEOAE tip design leaves a  0 5mm gap between the end of the  coupler tubes and the end of the tip  Therefore  the tubes should never  come into contact with the patient     OAEs should NOT be conducted if there is evidence of fluid of any kind  in the ear canal  Not
90. s is particularly useful if the Otoport is used with a  Docking 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 Patient  or All unprinted tests     Printing will only start if the Otoport is on and displaying one of the main  module screens  see chapter 3 4      If Cancel is selected during the print  three options are available     lf Cancel Print is selected  the Otoport will not attempt to automatically  print the test s  again  test may still be selected to be printed manually      If Retry is selected then printing will recommence   If Stop On Connect is selected then the On connect setting is turned off  and the Otoport will not attempt to print tests on connection in future     Worklist    The Worklist allows details for multiple patients to be entered into the  Otoport prior to testing  If Worklist is set to On  the list is accessible  from the main menu  see chapter 6   If the Worklist is set to Off  it is not  available     Language    Select the language you require using the left and right arrowkeys     Otoport Lite   81  User Manual    sss System info    8 5 5 a The System Info screen provides information on the Otoport     855b System Details    8 5 5 c System Details displays information for Otodynamics engineers   See  chapter 16 3 for further details      855d About    ABOUT  Lite Otocheck DP  Revision 3 17 1
91. scanner  position the Otoport parallel with the  barcode at a distance of around 10cm and select Scan  Line up the red  light across the barcode     96    CHAPTER TEN  scanning    10 2 1 c    10 2 1 d    10 2 2    10 2 2 a    10 2 2 6    10 2 2 c    The Otoport will show a Scanning screen     Wi       CANCEL    When the barcode is read successfully a beep will sound and the barcode  number will populate the required field  Select Cancel to abort the scan     RFID scanning    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 to the Otoport scanning  window  Select Scan and swipe the Otoport across the card slowly  The  Otoport will show a Scanning screen as above     When the RFID card is read successfully a beep will sound and data will  populate the required fields  Select Cancel to abort the scan     Otoport Lite   97  User Manual    os When to use the scanners    1031 Entering patient details    ENTER DETAILS    ID JUDLS700  Family AUTO    Edd  Mmm yyyy      SCAN TEST       10 3 4 a If a scan option is fitted  patient details may be entered using the Scan  facility  To access the Scan function  first press any key  except the menu  selection keys   The central menu option will now change to Scan     Select Scan to populate the patient details  Make further edits manually  with the keypad     10 3 1  Then continue to ei
92. t  Turn off the device and then switch it on again     16 4 d 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 screwed up correctly   See Connecting the  probe in the Getting started section      16 4 e Run the probe checks  see chapter 11   If the tests are    OK    the device is  functioning correctly and can be used for OAE testing again     16 4  If you receive the Instrument fault message again  contact your dealer or  Otodynamics for support     D         e   e           s  2    gt   el  Sow          128   CHAPTER SIXTEEN  Troubleshooting    16 5    16 5 a    16 5 b    16 5 c    16 5 d    16 5 e    Hardware fault messages    The Otoport performs a series of hardware tests when it is first turned  on  In the event of a fault being detected the following message will be  displayed     Hardware Fault  Error 03    x       The error code 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 doesn t  reoccur     If you receive the hardware fault message again  contact your distributor or  Otodynamics for support     Error 2    The above message indicates that excessive noise was detected during  start up  The noise may have been detected through the probe  if it was  connected  Noise detected through the probe does not indicate a
93. t  stored values which may be blank for a newly registered probe  Before  entering Probe Test the user will be prompted to register the probe with the  Otoport     Select Back to exit the Probe Test screen and return to the Configuration  screen     11 2    11 2 a    11 2 b    i hres    11 2 d    11 2       11 2 f    11 2 9    11 2 h    11 2     412     Otoport Lite   105  User Manual    Cavity test    Due to mechanical or electrical failure or a faulty probe  the system may  itself produce signals during a test that have similar characteristics to an  OAE response  The test cavity will not produce any OAE signal so any   signal produced in the cavity is the result of a fault     By performing an OAE test in a cavity rather than an ear it is possible  to determine whether signal responses recorded in the ear are being  generated by a fault     Before starting a cavity test  for the TE model  change the Test Settings  Display to Circles  for the DP model  change the stimulus level to 65 55   see chapter 8 Configuration      Follow the instructions on the previous page for inserting the probe into the  test cavity     Start a test on the Otoport as you would for an ordinary ear  see chapter 5  Test       Follow the Checkfit and Test screen sequences until the test stops  Ina  cavity the Checkfit screen should indicate a large cavity volume     If the result No Valid OAE is displayed and the Circles are no more than  25 percent full when the test stops  the cavity test has passe
94. t Ear  Save Test to  Left Right Ear Again  may appear on Save if the patient   s previous test  was saved to the same ear  Select Yes to accept the current ear choice or  No to return to the Select Ear screen     If Auto print is selected  the print routine will be activated at this stage     Final review    After saving the user is given the opportunity for a final test review     There are options to Print the test results  to Retest the same patient or to  Finish and return to the main menu     TEOAE PASS    M  RETEST PRINT FINISH    Retest will start a new test for the same patient  This can be used to retest  the same ear or to test the opposite ear     Print will print the current test result or all the test results for the current  patient  see chapter 9 2      Test    56   CHAPTER FIVE    Test    5 8    5 8 a    5 8 b    5 8 c       RESULT LAST    After one ear has been tested  further tests can be added to the same  patient record by selecting Last from the main menu  Patient details can  be amended and tests printed using this function     From the Main Menu select Last  The Patient Details screen is  displayed     PATIENT DETAILS  Wi  ID Notes OGPM1V00  Name Brown  D O B 05 Jan 2012  Gender 1 Female         BACK PRINT TEST    Select Test to start a new test with the patient details displayed  Select  Print to print all tests saved to this patient  or select Back to return to the    main menu     5 8 d    5 8 e       Otoport Lite   57    User Manual    The details s
95. the data   Select Cancel to pause the test  Select Yes to end the test and discard the  data  No to resume the test and Checkfit to restart the test at the Checkfit  stage     5 3 4    5 3 4 a    Test results    Otoport Lite   49  User Manual    The following table lists all possible test results with the associated result  graphic and gives an explanation of the circumstances under which each  result would be shown     Test Result    DPOAE Pass         Note     Noisy    IH       ye    Poor Probe Fit       oO  i    No Valid OAE  9     Too Few Bands  9     Stopped Too  Soon    p    Description    The data collected has met the criteria set  The  optimum test setting will depend on your application   e g  screening or clinical measurement    see 8 3 Test settings     The following results will only occur if a DPOAE Pass  is not obtained    The noisy data collected is three times greater than  the low noise data collected    Probe fit movement is detected that results in less  than 85  of stimuli reaching calibration levels    The data collected has not met the set pass criteria  and the test conditions were acceptable    Insufficient bands meet their pass criteria    The test has been ended manually before the  required minimum amount of data has been collected    Test    50   CHAPTER FIVE    Test    5 4    5 4 a    5 4 1    5 4 1 a    5 4 1 6    5 4 1 c    5 4 1 d    Quick Save option    The options available from the test result screen depend on the Quick  Save option  see ch
96. the ear is exposed to sound  Whilst the  level of this exposure is harmless under normal test conditions  it is not  recommended that tests be allowed to continue indefinitely even if there is  no result     The Otoport includes    stop criteria    which will automatically terminate the  test when an OAE pass has been achieved or after five minutes     Whilst this limits the sound exposure in a single test  the user is responsible  for limiting the number of separate tests performed on the same ear     The Otoport has built in signal analysis proven to distinguish true  otoacoustic emissions from artefactal signals  Checks should be performed  weekly and before each test session to confirm the system continues to  operate effectively  see chapter 11 Probe checks      In exceptional 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 should be  considered highly suspect and should not be relied on     The probe   s coupler tubes which carry sound to and from the ear canal  are protected from contamination by the disposable tip  The probe should  never be inserted into the ear without a disposable tip attached  Doing so  risks damage to the ear by the probe body and contamination of the probe  by the ear     If contamination occurs the coupler tubes must be replaced  see 13 2  Changing probe coupler tubes              Hr   0      
97. ther test or save the result as normal     10 3 2 Adding a patient to the Worklist    WORK LIST  NAME ID INOTES  Roberts OSPM1V02  OGPM1IVOS    homson OGPM1V04       10 3 2 a If the Worklist already contains patients  scroll down to the last line  which  will be empty  then select Scan  When the scanned details have been  entered  you may make further edits manually with the keypad     10 3 2  Then continue to either test or save the result as normal     98    CHAPTER TEN    Scanning    1033 At login    10 3 3 a    10 3 3 b    10 3 3 c       NEW USER    User ID  Password  Admin    CANCEL SCAN SAVE    In order for a user to login using the scanning method it is necessary to set   up their login account in the Users area  see chapter 8 Configuration for  more details   On the New user screen  select Scan  The RFID method  can set all user parameters  For barcode scanning  the user name  ID and  password are automatically set  but the other user parameters need to be    set manually   To login using a scanner  select Scan on the login screen     M       SCAN LOGIN    The Otoport will automatically login the user selected with their appropriate  access rights and present the main menu     11    11 0 a    11 0 5    11 0 c    Otoport Lite   99  User Manual    Probe checks    Damage or malfunction of the Otoport or the probe can lead to errors in  OAE recording  To ensure that any faults are detected before they lead to  faulty data collection  the following tests can be performed  
98. time Approx 40s  Min data collected 0 64s per frequency    c     ad          5  D   m  S  o   Oo       12                CHAPTER EIGHT  Configuration  8 3 5 Neonate  8 3 5 2 With Neonate setting On the user is warned if the response from the probe  indicates a large ear canal  This provides an additional check of probe fit  for users who are testing only babies   A  Probe out of ear  or large cavity  detected  CANCEL CHECKFIT START  8 3 5  The warning message is displayed after checkfit and before test start   Start starts the test as normal  Checkfit returns the user to Checkfit   Cancel returns the user to the Main Menu   8 3 5 c Ear canal cavities greater than around 0 5cc will trigger the warning   8 3 5 d With Neonate setting Off  no warning message is displayed if a large ear  volume is detected   8 3 6 NReject  8 3 6 a The threshold above which data is rejected can be fixed at High  Medium    or Low  Alternatively  Variable can be selected allowing the reject level to  be adjusted during checkfit and test     8 3 7    8 3 7 a    8 3 8    8 3 8 a    8 3 8 b    8 3 8 c    8 3 9    8 3 9 a    8 3 9 b    Otoport Lite   73    User Manual    Extend    DP TEST       lf Extend is On  the user has the option to extend the test beyond the  normal maximum duration  This may be useful if the test result is very  close to meeting the pass criteria at the normal test end  If Extend is On   the central key on the Otoport will show Extend when there are around  15 seconds of test time
99. tion information    When conditions are good for data collection TE TEST will be shown at the  top of the screen and progress indicators will move either side of the title to  show that a test is currently running  If test conditions are not optimum  a  highlighted message will appear  indicating the problem   See 5 1 1 p      Data summary screen    IE Jes     15 4 dBSPL   6 Sec   ANY 2 BANDS      i  END       Pressing the left and right arrow keys displays the Data Summary Screen     This screen displays the current total OAE  the total noise  the time elapsed  and the current test mode  Press the left and right arrow keys again to  return to the test screen     Test    42    CHAPTER FIVE    Test    5 2 3    5 2 3 a    5 2 3     5 2 3 C    5 2 3 d    5 2 3 e    5 2 3 1    5 2 3 g    5 2 3 h    5 2 3 i    Test stop reasons    There are four possible ways in which a test can stop  AutoStop   Maximum NLo Sweeps  Test Timeout and Manual End  When the test  stops the data collected is assessed and a result given as a pop up graphic  and then written highlighted at the top of the test screen  The Otoport will  beep once if a test has stopped with a TEOAE Pass result and will beep  twice if the test has stopped with any other result     AutoStop    If the test data collected meets the set pass criteria then the test will  AutoStop and a large checkmark will be displayed     Maximum number of NLo sweeps    If a test has not met the set pass criteria it will stop when the Maximum   N
100. toport first     It is also not possible to set the NICU field to Yes if Location  is set to Outpatient or At home  The fields are automatically  corrected in this case     Alternatively  the user may select Records and choose an existing patient  record to which the current results may be appended     If the test was run using the Last option test results will be saved with the  same details as the last performed test     If a scanner is installed on the Otoport  pressing any arrow key or key on  the data entry panel will enable scan functions to enter patient details  see  chapter 10 Scanning for more information      When the patient details are entered  select Save to store the result     Test    04   CHAPTER FIVE    Test    5 6 1    5 6 1 a    5 6 1 b    Select left or right ear    SELECT EAR       The Select Ear screen represents the patient facing you  By defaulting to  a No Ear Choice the Select Ear screen forces the user to choose an ear  before the test can be saved  Press the right control key or the right arrow  to select the Left Ear or press the left control key or the left arrow key to  select the Right Ear     CONFIRM       RIGHT SAVE    When the correct test ear has been selected press Save to save the test  record to the database  A screen will be displayed briefly which confirms  the test has been saved        5 6 1 c    5 6 1 d    5 7    5 7 a    5 7 b    5 7 C    5 7 d       Otoport Lite   55  User Manual    The pop up message Last Test Saved to Left Righ
101. tored can be edited by using the up down keys to locate the  correct field and then entering the new data using the keypad  All fields  except Location  Facility and NICU can be edited  When an edit has  been made the screen will change     ENTER DETAILS    ID Notes  Brown    05 Jan 2012  4 Female      SAVE    If you are happy with the changes you have made select Save  To discard  the changes select Cancel  Once changes are saved or cancelled the  initial menu options return  Back  Print or Test      Test    58   CHAPTER FIVE    Test    5 9    5 9 a    5 9 b    Result       RESULT LAST    Select Result to review the tests results for the current patient     Select displays the detailed result for this test  Select Print to print this test    result     TEQAE  TEOAE PASS    Any2Bands  Ege    13 200 GG  Noise 6 60ellLte2 3 4  14 Mar 12 10 23 ADN  PRINT SELECT       TEOAE PASS    0000 e    iw 2 F ad  KHz    RETEST PRINT FINISH    6 0 a    6 0 b    6 1    6 1 a    6 1 5          Otoport Lite   59  User Manual    Worklist    The Worklist allows details for multiple patients to be entered into the  Otoport prior to testing  This eliminates the need for data entry while with  the patient  allowing for faster  more flexible testing  The Worklist is On by  default but can be switched Off in the Config area  see chapter 8      Access the Worklist by using the left or right navigation keys from the main  menu     Adding Patients    WORK LIST    If the worklist already contains patients
102. ual    155 14 Notes     If forced it is possible to insert the charger connector into the  Otoport the wrong way up  In this position the Otoport will not  charge     Disconnect the connector and re insert with the arrow facing  upwards     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     08 2Ws       15 5 1 e When the Otoport is connected the display will show the current battery  level  This screen is updated every minute to show how the charge is  progressing     15 5 1 A full charge will take up to 4   hours     15 5 1g When the device is fully charged a large tick will appear on the screen        hn  O   gt   O   3  we  tan  O  2   O  ae  O       124   CHAPTER FIFTEEN  Otoport power    15 5 2    15 5 2 a    15 5 2 b    15 5 2       15 5 2 d    15 5 2 e    15 5 2 f    15 5 2 g    15 5 2 h    15 5 3    15 5 3 a    Additional charge indicators    There are additional charge indicators on the side of the Otoport        e Power light   The green light below the plug symbol shows that the  device is powered     e Charging light   The orange light below the battery symbol will illuminate  when the device is being charged     Note     If the device appears fully charged  with a tick displayed on  screen  but the charging light is still on  if convenient  allow the  device to continue to charge until the charge light goes out     It is possible to leave the charge
103. wing conversion factors convert between the signal level generated  in the ear simulator by the Otoport stimulus and the level that would be  generated by a    reference stimulus    of the same peak to peak electrical drive    The    reference stimulus is a 100uUS unipolar rectangular pulse  as defined in  EN60645 3       rectangular stimulus   3 0dB  bipolar stimulus   2 4dB    Otoport Lite   145  User Manual    Suppose  for example  that a stimulus level of 90dB is reported by the Otoport  during stimulus setup  rectangular stimulus   If this stimulus was replaced by the  reference stimulus  of the same amplitude  the level generated in a IEC 60711  ear simulator would be     90dB    6 1dB   3 0dB   86 9 dB SPL peak to peak equivalent             g  Polarity of stimulus     The polarity of the stimulus varies between positive and negative  according to  the TEOAE test sequence      h           Repetition rate     The stimulus is repeated every 12 5mS during standard Otoport TEOAE setup  and testing      i  Covered in  a  above     j  Covered in  f  above    N  S     el  G  0     0  Q  Q        G   lt   S  oan  Q  Q          146   CHAPTER TWENTY ONE    Technical specifications    xa Symbol explanations    TRAINING       el    REQUIRED    Class Il    Type BF    Caution    USB 1 1    When discarded  the item must be sent to  separate collection facilities for recovery and  recycling    Probe socket    Battery charging indicator    Power supply connection    Stimulus OK indicat
104. within this range for the duration 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 option is shown in  black     Note     When using multiple Otoports with wireless connection to a  single printer  the last Otoport to print must be switched off  before another Otoport can print     The printer is powered from batteries  or can be connected to mains  power when printing  Prior to printing  switch on the printer  using the  power button on the top  When the printer is powered  a green light will  be displayed  To save power  the printer will automatically switch off after  30 minutes of inactivity  If it is connected to mains power  the printer will  remain on indefinitely     90   CHAPTER NINE    Printing    2 34    9 3 g    9 3 h    9 3 i    9 3j    9 3 k    9 3 1    When a print is initiated  the Otoport will establish communication with the  printer  The screen Searching for Printer will be displayed     Searching for printer          The printout will then commence  Once the 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 Printer not connected  will be shown briefly and then the screen  from which the print was initiated will be displayed  Check the printer is  connected correctly and swit
    
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