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Otocheck ABR

User Manual

37

Test troubleshooting

6.2

  High myogenic activity/artefact reject

 

The most common cause of electrical interference is myogenic (muscle) 

activity from a restless baby. 

   

Solutions: 

 

1.  Check that all electrode and cable connections are secure.

 

2.  Switch off lights in the test area.

 

3.  Do not place the Reference (Common) electrode close to the heart 

(front or back of the patient). Noise can be generated by a large EKG 

response.

 

4.  Smooth and swaddle the baby in an effort to calm him/her. Note that 

electric muscle artefacts may arise from non-moving but tensed muscles 

(isometric contraction) – pay particular attention to the nape of the neck 

with this condition.

 

5.  Touch each electrode to identify which is causing the problem, try:

 

  • holding the skin around the electrode taut

 

  • maintaining light pressure on the electrode

 

  • gently stroking the baby’s head

 

  • repositioning the baby’s head

Summary of Contents for Otocheck ABR

Page 1: ...Otocheck ABR Issue 4 Otocheck ABR User Manual...

Page 2: ...ards Doc Ref MANABR4 4 Copyright Notice No part of this publication may be copied by any means translated or distributed to third parties without the express written permission of Otodynamics Ltd Copy...

Page 3: ...2 Optional accessories 15 2 3 Controls indicators and connections 16 2 4 Labelling 17 3 Getting started 19 3 1 Connecting probes and electrodes 19 3 2 Initial charge 22 3 3 Using the keys and keypad 2...

Page 4: ...al hearing 38 7 ABR test 39 7 1 Impedance check 40 7 2 Checkfit 44 7 3 Ear cup Checkfit 46 7 4 ABR test 47 7 5 Quick Save option 54 7 6 Review 55 7 7 Save 56 8 Worklist 59 8 1 Adding Patients 59 8 2 T...

Page 5: ...nter 93 11 9 Changing the battery 94 12 Scanning 95 12 1 Scanning facility 95 12 2 Scanner types 95 12 3 When to use the scanners 97 13 Quality tests 99 13 1 Probe test 99 13 2 ABR cable test 104 13 3...

Page 6: ...uipment troubleshooting 124 18 1 Otocheck lock up 124 18 2 Switch on 124 18 3 System details 124 18 4 Instrument fault message 125 18 5 Hardware fault messages 126 19 Training 127 20 Obtaining service...

Page 7: ...for use with infants The ABR screening function uses conventional Fsp methodology to detect the response supported by waveform identification Template Correlation which is optimised for infants from 3...

Page 8: ...it is not recommended that tests be allowed to continue indefinitely even if there is no result The Otocheck includes stop criteria which will automatically terminate the test when an ABR pass has bee...

Page 9: ...ocked microphone tube will prevent the Otocheck from sensing the stimulus level in the ear As a result the Otocheck may apply a louder than normal sound to the ear All surfaces of the Otocheck may be...

Page 10: ...monly known as auditory evoked potentials A response which occurs within 20ms of the onset of the stimulus is referred to as an Auditory Brainstem Responses ABR As the amplitude of the ABR is very sma...

Page 11: ...fication 2 Equipment identification 2 1 Supplied in Otocheck ABR kit Otocheck ABR REF ABR EC1 Electrode cables 1m REF ABR EC2 Electrode cables 2m REF ABR SK Starter kit of electrodes skin preparation...

Page 12: ...entification 12 Equipment identification REF ABR CAV Probe cavity and ABR cable tester REF PR CLIP Probe cable clip REF PR POUCH Drawstring probe pouch Re order quantity 10 REF PR UGS UGS probe REF OA...

Page 13: ...ABR CAS Equipment case for Otocheck ABR kit TPC probe coupler tubes x 5 See chapter 15 for fitting instructions Re order codes REF TPC 10 quantity 10 REF TPC 100 quantity 100 REF BGS BGS probe body an...

Page 14: ...ntification 14 Equipment identification REF OTOLINK Otolink software CD Documentation pack Includes instrument and software manuals quickstart and probe use guides REF OP CAB PC downoad cable REF OP C...

Page 15: ...ABR User Manual 15 Equipment identification 2 2 Optional accessories REF OMP R Otocheck printer Wireless printing REF ABR CUP Ear cups Optional accessory for ABR screening as an alternative to direct...

Page 16: ...ets and electrode sockets Impedance check indicator LEDs Quick release clips Otoport Lite controls and keypad USB PSU connected and battery charging indicator LEDs Charger PC cable socket Menu selecti...

Page 17: ...l 17 Equipment identification 2 4 Labelling 2 4 1 Symbols The label uses the following symbols DC Caution Refer to user manual Class II electrical protection double insulated Type BF applied part Manu...

Page 18: ...cs Item reference Otocheck ABR Screener 11 Production date 31st January 2015 21 Serial numbers 1234 Otoport 1234 ABR 240 Additional product ID BRT used to identify any hardware modules fitted 250 Seco...

Page 19: ...ting started 3 1 Connecting probes and electrodes The connections panel for probes and electrodes is found at the top end of the module 3 1 1 Connecting the probe The probe plug contains a key that mu...

Page 20: ...the knurled sleeve in a clockwise direction until finger tight 3 1 2 Disconnecting the probe To disconnect the probe unscrew the knurled sleeve in an anticlockwise direction until the thread is diseng...

Page 21: ...ectrodes that are terminated with 1 5mm Touchproof DIN 42 802 connectors may be used Carefully align the electrode connector plug with the appropriate electrode socket observe colour coding and then p...

Page 22: ...a circle enable you to execute the functions offered on the screens Their functions vary from screen to screen but generally the right circle key provides affirmative options and the left square key p...

Page 23: ...d first then lower case then numbers e g ABCabc2 For subsequent characters lower case is shown first e g abcABC2 More characters can be stored than can be displayed on the screen Arrows are displayed...

Page 24: ...the date displayed or Cancel to ignore the changes If the date has not been edited it will remain as dd Mmm yyyy by default For Date of Birth entry D O B the Otocheck will not permit entry of a futur...

Page 25: ...econds following any key press and remains on during testing The backlight can be configured see chapter 10 Configuration 3 3 9 Stimulus and Noise OK indicators blue LEDs The two blue LEDs above the s...

Page 26: ...the keypad The display screen will show Switch Unit On Select Yes to confirm Otocheck switch on or No to turn the unit off again If Yes or No are not selected within two seconds of pressing the on off...

Page 27: ...ppear to the right of the logo to provide an indication of the Battery Power remaining Please refer to chapter 18 Power for battery information A prompt will be shown if the Otocheck is due to be cali...

Page 28: ...is selected use the data entry keypad to enter a corresponding Password if required for that user To improve security during Login a symbol will replace each character as it is entered in the Password...

Page 29: ...the main menu screen From here you can view the Result of the last test select the Last patient tested or perform a Test ABRcustom only available if configured see chapter 10 Use the left and right a...

Page 30: ...y discharge from the ear to be tested Choose a quiet room without background noises Ensure the patient is comfortable and settled Ensure you can clearly see the ear to be tested 5 2 Environment checks...

Page 31: ...r and free from debris If debris subsequently enters the probe sound tubes do not attempt to clean them the coupler tubes should be changed The correct size tip will look slightly larger than the ear...

Page 32: ...eft ear or 5 o clock for right ear Push the probe firmly into the ear canal at this angle Hold the probe for several seconds Then release the probe No discomfort should be felt by the patient The weig...

Page 33: ...tely firm strokes in order to obtain a satisfactory connection to the skin Excessive caution with skin preparation can disturb the baby more than firmer strokes If using a wet prep use a gauze pad to...

Page 34: ...ons avoid hair when possible When using wet gel electrodes the sticky area around the central gel should be pressed to the skin not the central area itself Shoulder common black and nape of neck negat...

Page 35: ...is optimised for the electrode placements described above Alternative placements are possible including Recommended Alternative 1 Alternative 2 Positive Red High forehead High forehead High forehead N...

Page 36: ...ly onto the electrodes if impedance is only slightly high 3 Remove and re prep the electrode site that has high impedance If that fails to work re prep all sites 4 If re prepping does not work try a f...

Page 37: ...close to the heart front or back of the patient Noise can be generated by a large EKG response 4 Smooth and swaddle the baby in an effort to calm him her Note that electric muscle artefacts may arise...

Page 38: ...ent in the room 3 Do not use mobile cellular phones when operating the equipment 4 Separate the electrode cables from the probe cable if intertwined 5 Move to a quieter location if possible 6 4 No res...

Page 39: ...able and may differ if other cables are in use Connect the electrode leads and the probe to the ABR unit and prepare your patient Connect the red ve cable to the high forehead the white ve cable to th...

Page 40: ...test conditions are good The ABR test will start automatically if the electrode impedances are good and the electrical noise EEG is low for a few moments If test conditions are moderately good If tes...

Page 41: ...l not be possible to start a test manually A message on the screen will show the problem It will tell you if EEG Noise Powerline Noise or Impedance are preventing the test from starting Try to resolve...

Page 42: ...More than 16 k Poor The green LED lights on the top of the ABR unit will be lit if the connection of the electrode closest to that light is optimum good or moderate Autostart requires that all impedan...

Page 43: ...vices This level is high if there is a lot of interference from electrical noise and or one or more of the electrodes is poorly connected has high impedance If impedance levels are acceptable but the...

Page 44: ...s 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 Otocheck repeatedly plays a...

Page 45: ...nal in an adult may occur because of wax blocking the canal Noise level indicator A Noise Level Indicator is shown on the right of the Checkfit screen The red green bar moves in response to changes in...

Page 46: ...will be prompted with a message to confirm There will be three options Yes No and Checkfit Using the probe direct in a neonate ear will always create a small cavity but using large adult ears may trig...

Page 47: ...ally when either the circle is filled there is a ABR response present when the blue NLO bar is filled a full set of data has been recorded but no response has been detected or when test noise ABR nois...

Page 48: ...o NLo shows the number of sweeps accepted into the average NHi shows the number of sweeps rejected due to high electrical noise levels Accepted Shows the number of sweeps accepted into the average Rej...

Page 49: ...clear response is present right disagreement between them shows the presence of noise left Excess noise may obscure an ABR The alternative waveforms are displayed in orange and yellow The average of...

Page 50: ...tart 7 4 5 Pausing the test Select Pause to temporarily stop data collection You may wish to do this if the test environment worsens for example the subject becomes temporarily active an electrode bec...

Page 51: ...e checkmark will be displayed The test result can be saved at this point or the results can be reviewed prior to saving If Review is selected three screens are available by using the left and right ar...

Page 52: ...circumstances under which each result would be shown Test Result Description ABR Pass The data collected has met the pass criteria A clear ABR has been found Note Optimum pass criteria will depend on...

Page 53: ...trical equipment prevented the test from passing The Fsp pass threshold was elevated due to this interference and the Fsp did not reach this higher threshold High Impedance The electrode impedances me...

Page 54: ...o 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 If Automatic...

Page 55: ...ck Save Off If Quick Save is Off select Save to skip to the Patient Details screen ready to Save Select Review to view the data of the completed test prior to saving Select Cancel to discard the test...

Page 56: ...ossible to store different facilities for different patients If you wish to change the Facility download and erase all test records from the Otocheck first It is also not possible to set the NICU fiel...

Page 57: ...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 R...

Page 58: ...ight 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 scr...

Page 59: ...y default but can be switched Off in the Config area see chapter 10 Access the Worklist by using the left or right navigation keys from the main menu 8 1 Adding Patients If the worklist already contai...

Page 60: ...details Up to 50 patients may be added to the Worklist 8 2 Testing from the Worklist Scroll to the required patient Select Test to begin testing this patient When a test has been saved to a patient t...

Page 61: ...ients Scroll to the required patient Select Delete to remove Select Yes to delete the selected patient from the Worklist Select All to delete all of the patients from the Worklist Select No to return...

Page 62: ...may be erased from the Memory Status screen accessed from the Configuration area see chapter 10 Records also allows the user to select a previously tested patient for a new test Selecting Records fro...

Page 63: ...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 li...

Page 64: ...st from this screen starts a new test the result of which will be saved with the records of the selected patient Selecting the up and down arrow keys on the patient details screen displays the patient...

Page 65: ...that there are other saved test records for this patient The left and right arrow indicators display the Patient Details for this patient Select Print to print an individual test summary Select Back a...

Page 66: ...ty Tests to check the performance of the probe or the ABR electrode cables Select Test Settings to change test display and pass criteria Select Date Time to set the current date and time Select System...

Page 67: ...the probe and elecrode cable tests are in chapter 14 Quality tests 10 3 Test settings The Otocheck ABR has two different ABR test modes ABRscreen and ABRcustom ABRscreen is optimised for the screenin...

Page 68: ...HL If Stim Level is set to OFF then the selected mode ABRscreen or ABRcustom is not available for testing and it will not appear in the main menu carousel The ABRscreen mode is intended for newborn he...

Page 69: ...lus level 1dB steps are intended for the setting of precise custom stimulus levels e g for compatibility with prior screening practice Low stimulus levels down to 5dBnHL can be used for the audiologic...

Page 70: ...staken for an ABR The minimum fixed Fsp threshold is higher than the largest Fsp ever likely to be achieved by chance in EEG noise The minimum TC requirement should be achieved when recording an ABR w...

Page 71: ...is setting allows the use of ear cups and it can be set in three different ways OFF Will always go into test assuming ear cups are not being used AUTO Will detect whether ear cups are being used and p...

Page 72: ...mulus level Stim Type is configurable only in ABRcustom default is chirp in both modes Start If Start is ON then the ABR test will proceed from the Impedance Check screen to data collection autostart...

Page 73: ...users who are testing only babies The warning message is displayed after Checkfit and before the test starts Selecting Start will start the test as normal Checkfit returns the user to Checkfit Cancel...

Page 74: ...ue 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...

Page 75: ...ng Erase deletes all test records from the Otocheck 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 le...

Page 76: ...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 ignor...

Page 77: ...raphic on the right of the screen conveys the total remaining battery power The battery segments are shaded according to the following criteria Segments Displayed Battery Power 7 95 100 6 75 94 5 55 7...

Page 78: ...o PC Load then the Otocheck can use Bluetooth communication to send test results to a PC Details of how to set up wireless download to PC are included in your Otolink manual If Bluetooth is set to Pri...

Page 79: ...ancel to discard any change Note To avoid printout duplication it is not possible to set Auto Send to On and End Data to Patient Print If Print is set to Automatic then the test result is automaticall...

Page 80: ...All unprinted tests Printing will only start if the Otocheck is on and displaying one of the main module screens see section 4 4 If Cancel is selected during the print three options are available If...

Page 81: ...identification and mode of operation The firmware revision number and issue date is stated together with the unit s unique hardware ID The next scheduled Calibration Due date is also shown A dash is s...

Page 82: ...only optional Admin Select Yes to give the new N A user administrator rights Select No to restrict the user N A to screener rights The User ID is added to a saved test record to identify the user who...

Page 83: ...ils 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...

Page 84: ...available on Bluetooth enabled Otocheck ABR and Otoport instruments If a Bluetooth module is fitted a Bluetooth symbol shown above is included on the product label Downloading can also be performed w...

Page 85: ...ructions When the connection to the PC is ready to send data the PC Load text on the Otocheck screen is green If the connection is not complete then the PC Load text on the Otocheck screen is black Bl...

Page 86: ...an print and download The Otocheck provides flexible options as described on the following pages Print and PC Load settings are located under Configuration in System Setup Bluetooth must be set to Pri...

Page 87: ...download when the test is saved see 10 5 4 Setup for details The test is saved and a print download initiated with one key push 11 3 3 Printing or downloading from records Results can be printed or do...

Page 88: ...ferent tests for the patient using the up and down arrow keys and select Print or PC Load Select PC Load on the Records menu to download all new records for all patients and tests that haven t previou...

Page 89: ...onnection to a single printer the last Otocheck to print must be switched off before another Otocheck can print The printer is powered from batteries or can be connected to mains power when printing P...

Page 90: ...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 Otocheck w...

Page 91: ...d spooled and printed when the detected condition is rectified The printer s green light will flash when a print job is being stored 11 6 Printer light summary The light at the front of the printer ha...

Page 92: ...unt 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 p...

Page 93: ...A full charge will take approximately 15 hours Charger jack plug socket The printer can be used as normal whilst charging Once fully charged the printer has enough power for around 10 hours standby u...

Page 94: ...ynamics To change the battery pack Remove the screw 1 from the battery compartment cover TRAINING REQUIRED Push down and slide back the battery compartment cover 2 Remove the old battery pack and disc...

Page 95: ...ogin Each operator can be assigned a login card which the Otocheck will scan and verify in order to provide access to the machine 12 2 Scanner types The Otocheck has two scanning methods available 12...

Page 96: ...ans radio frequency identification RFID chips which can hold enough alphanumeric data for a complete patient data record on the Otocheck To scan with the RFID scanner hold the card up to the Otocheck...

Page 97: ...option will now change to Scan Select Scan to populate the patient details Make further edits manually with the keypad Then continue to either test or save the result as normal 12 3 2 Adding a patient...

Page 98: ...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...

Page 99: ...u 13 1 Probe test Probe Test is an option accessed from the configuration menu see chapter 10 Configuration A Probe Test should be performed regularly to monitor the calibration of the probe s output...

Page 100: ...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 Selec...

Page 101: ...e 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 rep...

Page 102: ...selecting Retest ensuring the ear piece is firmly inserted in the test cavity A Query result indicates that there have been changes in the probe but that these changes are not large enough to invalida...

Page 103: ...e 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 fre...

Page 104: ...le Test and wait for the result to be displayed If the electrode cables are OK then a large tick is displayed on the screen If any of the cables fail the test a large cross is displayed Select Details...

Page 105: ...s the cavity test has passed 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...

Page 106: ...spare probe body lid See chapter 2 Equipment identification for details 14 2 Probe cable clip The probe cable clip is provided to aid the practical aspects of positioning and securing the probe cable...

Page 107: ...t and release the plunger The position of the clip on the cable can be adjusted if necessary Open the crocodile clothing clip Attach the probe cable clip to the patient s clothing If the cable slips t...

Page 108: ...Small newborns T5 5B REF T T5 5B Fits 5 5mm ear canal Most newborns T11M REF T T11M Fits 11mm ear canal Large adult ears T13M REF T T13M Fits 13mm ear canal Extra large adult ears T8M REF T T8M Fits 8...

Page 109: ...aning fluid into the tubes The design of the tips for the UGS probe 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 wi...

Page 110: ...c wipes and dried with a tissue immediately afterwards Do not allow liquids to enter the sound tubes Coupler assembly Each coupler assembly has two sound tubes These are protected from ingress of fore...

Page 111: ...obe fig 4 15 2 2 Reassembling the probe Fit the new coupler tubes to the probe assembly fig 1 Fit the outer shell figs 2 and 3 followed by the lid fig 4 Click the lid into place using firm finger pres...

Page 112: ...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...

Page 113: ...than the probe ear piece and cable the Otocheck hardware should not come into contact with the patient being tested Otodynamics probe tips are disposable and for single use only A new tip should be u...

Page 114: ...aned if it becomes contaminated Clean surfaces of the Otocheck with an alcohol based sterile wipe or cloth and antiseptic fluid Dry the Otocheck with tissue immediately afterwards Do not allow liquid...

Page 115: ...tery life depends on the Otocheck usage pattern 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...

Page 116: ...nd return to the previous screen displayed If the Otocheck 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 us...

Page 117: ...a battery indicator which displays the remaining level of battery charge The indicator has 5 segments which convey the total Battery Charge remaining The battery segments are shaded according to the f...

Page 118: ...tery 17 4 2 Critical battery When the battery power reaches 7 remaining a Critical Battery warning message will appear on screen This equates to approximately 10 minutes of use Select OK to accept the...

Page 119: ...to a PC Note Do not charge more than one Otocheck on the same PC at any one time 17 5 1 Connecting the Otocheck ABR to the charger cable Switch off the instrument prior to charging Connect the mains l...

Page 120: ...up to 4 hours When the device is fully charged a large tick will appear on the screen 17 5 2 Charge indicator lights There are additional charge indicators on the side of the Otocheck ABR Power light...

Page 121: ...s may be convenient if you wish to leave the device charging overnight 17 5 3 Disconnecting the Otocheck When the charging cable is disconnected the power light will extinguish on the Otocheck and if...

Page 122: ...d then fully charging the device see chapter 10 Configuration The condition utility is available from the Configuration menu by selecting System then Battery Selecting Condition and confirming will se...

Page 123: ...Otocheck ABR User Manual 123 Power 17 7 Additional battery care If the Otocheck is not in regular use in order to maintain the battery fully charge the device every two months...

Page 124: ...nd complete its start up sequence check that it is charged and try again If the Otocheck still fails to complete its start up sequence then contact your dealer or Otodyamics for support 18 3 System de...

Page 125: ...instrument fault the following message will be displayed at the start a test No stimulus will be delivered from the Otocheck probe and you will not be able to start a test Turn off the device and the...

Page 126: ...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 ab...

Page 127: ...y Training in the UK is provided by Otodynamics Ltd Training elsewhere is via an approved dealer who has been trained by Otodynamics Training on ABRs and use of the equipment may also be provided by p...

Page 128: ...nt to Otodynamics for service or repair please ensure all items particularly the instrument and probe are clean and free from contamination Otodynamics cannot guarantee the equipment will be contamina...

Page 129: ...apter 13 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 calibr...

Page 130: ...18 8ms Amplifier gain 75dB Amplifier CMRR 60dB at 100 Hz Input impedance 1M 10 nF Amplifier noise 20 nV Hz 0 1 1 kHz Input bandwidth 150 1000 kHz Notch filter None Impedance sense current 0 2 A Impeda...

Page 131: ...The frequency dispersion of the chirp is defined by the delay at frequency T f k f d with k 0 0920 and d 0 4356 The wide band chirp waveform was cosine filtered in the time domain to give the require...

Page 132: ...differing levels of EEG noise and power line interference in which the device can be used but without any ABR actually being present It is important to note that the measured sensitivity of an instrum...

Page 133: ...a realistic wide range of neonate electrode noise signals i e from sleeping to restless is processed by the device As no acoustic stimulation actually reached the ear no real ABR was present so all pa...

Page 134: ...imulus at a level of 35dBnHL and a rate of 52 per second The normal distribution spread of ABR amplitudes was determined from an historical study of 3200 infant ABR recordings at 30dBHL in particular...

Page 135: ...ng with a click stimulus rather than our short chirp will slightly decrease specificity because click stimuli generate a slightly smaller ABR response than a chirp of identical hearing level due to re...

Page 136: ...Electrode connectors compatible with 1 5mm Touchproof DIN 42 802 connectors Charging Data connector connects to Otodynamics PSU charging or to PC USB port USB 1 1or 2 0 via Data Cable Bluetooth wirel...

Page 137: ...ous 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...

Page 138: ...uencies above 4kHz 23 1 11 Environmental Protect from heat and radioactive sources Keep dry Transport and storage Temperature range 0 to 40 Celsius Pressure 23KPa to 101KPa Humidity 10 to 90 non conde...

Page 139: ...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 Compat...

Page 140: ...lies buildings used for domestic Harmonic emissions Class A purposes IEC 61000 3 2 Voltage fluctuations Complies flicker emissions IEC 61000 3 3 23 2 Electromagnetic Compatibility Otocheck ABR The Oto...

Page 141: ...kV differential Mains power quality should line s mode be that of a typical commercial or hospital IEC 61000 4 5 2 kV line s to 2kV common environment earth mode Voltage dips 5 UT 5 UT Mains power qua...

Page 142: ...l specifications The following functions of the Otocheck ABR are deemed essential performance and were tested for immunity in compliance with IEC60601 1 2 a The collection of Auditory Brainstem Respon...

Page 143: ...trengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equip...

Page 144: ...r radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey...

Page 145: ...5 3 5 7 10 11 11 22 100 35 35 70 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to t...

Page 146: ...e sound field is generated by the probe sealed in the ear canal by its tip d e Calibration cavity and measurement type For the purposes of EN60645 3 calibration was performed in an occluded ear canal...

Page 147: ...eck 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...

Page 148: ...planations Training required Class II Type BF DC Caution USB 1 1 When discarded the item must be sent to separate collection facilities for recovery and recycling Probe socket Battery charging indicat...

Page 149: ...eck ABR User Manual 149 Index Refer to operating instructions Otodynamics factory address Product catalogue number Product date of manufacture Product serial number Bluetooth enabled RF transmitter SN...

Page 150: ...e LEDs 25 Bluetooth 84 Brightness 76 C Calendar 137 Cavity test 105 Certification 18 Changing probe coupler tubes 110 Charging the Otoport 119 Charging the printer 93 Chirp stimulus 72 Choice bars 24...

Page 151: ...character table 23 Fsp 48 G Good Stimulus 16 H Hard reset 25 Hardware options 137 Hardware processing and storage 137 High EEG noise 53 High impedance 53 High mains noise 53 I Impedance check 40 Impe...

Page 152: ...cks 99 Quality tests 99 Query 102 R Records 62 Regulatory marks 18 RFID scanning 96 S Save 56 Scanner 17 Scanning 95 Select ear 57 Service 128 Skin preparation 33 Standby 117 Stimulus adjustment 45 St...

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