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Abbreviations

5

Abbreviations

ADC — analog-to-digital converter

VЕМ

P — vestibular evoked myogenic potential

AEP — long-latency evoked potential

TEOAE — transient evoked otoacoustic emission

ABR — auditory brainstem response

MC — microcontroller

OAE — otoacoustic emission

DPOAE — distortion product otoacoustic emission

PC — personal computer

DSP — digital signal processor

AEP — auditory evoked potential

SOAE — spontaneous oto

а

coustic emission

MLAEP — middle-latency auditory evoked potential

ASSR — auditory steady-state response

EcochG — electrocochleography/electrocochleogram

Summary of Contents for Neuro-Audio

Page 1: ...Technical Manual Neuro Audio Digital System for Auditory EP OAE and Screening PTA TM032 02 003 002 30 06 2020...

Page 2: ...Neurosoft 2020 5 Voronin str Ivanovo 153032 Russia P O Box 10 Ivanovo 153000 Russia Phone 7 4932 95 99 99 7 4932 24 04 34 Fax 7 4932 24 04 35 E mail info neurosoft com Internet www neurosoft com...

Page 3: ...se 21 3 1 Setting Up Procedures 21 3 2 Performing Tests 22 3 3 Troubleshooting 23 3 4 Actions in Emergency 25 4 Maintenance 25 4 1 General Requirements 25 4 2 User Maintenance 26 4 3 Periodic Maintena...

Page 4: ...this manual You can send your responses and recommendations at the following address P O Box 10 Ivanovo 153000 Russia or by e mail help neurosoft com You can find additional information on Neurosoft p...

Page 5: ...ssion ABR auditory brainstem response MC microcontroller OAE otoacoustic emission DPOAE distortion product otoacoustic emission PC personal computer DSP digital signal processor AEP auditory evoked po...

Page 6: ...ust be used by trained personnel only such as audiologists ENT surgeons hearing healthcare professionals trained technicians or personnel with a similar level of education in a hospital clinic healthc...

Page 7: ...ystem and surgical HF equipment to the patient simultaneously it can cause system damage or patient s flash burns in places of electrode placement plug in any products not included into the delivery s...

Page 8: ...es and licenses it supports the following tests auditory evoked potentials ABR AABR ECochG MLR LLR otoacoustic emission TEOAE DPOAE SOAE auditory steady state response ASSR multi ASSR cognitive evoked...

Page 9: ...DSP generates audio stimulator signal in a digital form which is converted to the analogous form by the digital analogue converter DAC Then the signal is amplified by the audio amplifier and delivered...

Page 10: ...e measurement mode and the LED indicator The channels are marked with figures 1 and 2 The on off indicator glows yellow when the unit is connected to PC and it glows green during the signal recording...

Page 11: ...obe There are two types of connectors to attach the headphones 3 5 stereo and 6 3 mono Depending on the plug they can be inserted in this or that connector If you use the headphones with 6 3 mono plug...

Page 12: ...tymotic Research 4 connector for bone vibrator The front and back panels of the bone conduction amplifier are shown in Fig 5 and Fig 6 The description of indicator colors is shown in Table 1 Fig 5 Fro...

Page 13: ...ge The built in rechargeable battery is charging from mains it usually takes 6 7 hours for complete charge Charge indicator green flashing Battery is fully charged Ready indicator red The bone vibrato...

Page 14: ...S1 128 barcode that includes the GTIN code and the serial number Fig 8 Fig 8 The GS1 128 barcode 1 identification key GTIN 2 start digit 3 company number 4 article reference 5 check digit 6 serial num...

Page 15: ...ting and setting the digital system select a place for it taking into consideration the power wiring and protective ground in the room and follow the requirements and recommendations listed below Requ...

Page 16: ...ugh the system connecting cables that leads to the equipment break down 2 3 Reducing Electrical Noise There are some factors that may impact ABR test results They are the electrodes placement and its...

Page 17: ...h a notebook as a part of the digital system take special measures to ensure the notebook ground contact to the outlet ground To do this use the power supply units with the required contact a tripolar...

Page 18: ...site should be wired and connected directly to the true ground using at least three earth rods The best test site for ABR recordings is 1 The electric magnetic shielded room it is also soundproof as...

Page 19: ...ere https neurosoft com en pages dealers The digital system consists of the electronic unit and can be supplied with the patient button depending on the delivery set variant Fig 10 The electronic unit...

Page 20: ...s 8 to USB connector 9 PC system unit Place the holder to the testing site as near as possible and fix the Neuro Audio electronic unit on it Connect the required equipment according to Fig 10 The elec...

Page 21: ...Check the Always trust software from Neurosoft LLC checkbox and press Install Fig 11 Windows Security window When the system is connected for the first time the message box will appear in the right b...

Page 22: ...mpedance measurement Switch on the impedance measurement mode see the user manual The order of signal recording and further analysis is given in details in the user manual If the bone conduction ampli...

Page 23: ...t work restart the computer Program message Link error Neuro Audio is not connected or defective Electronic unit of the Neuro Audio digital system is not connected to PC Check whether the electronic u...

Page 24: ...of the system Ground the computer safely Ask the electrician to check the quality of tripolar sockets and the integrity of protective ground circuit The presence of powerful noise sources X ray equip...

Page 25: ...ical insulation disturbance of any digital system component which causes the emergency fire mechanical failure flood medical staff evacuation and occurrence of threat of electrical shock for patient o...

Page 26: ...the TEOAE mode connect the OAE probe to the system remove the ear tip and insert the OAE probe into the test cavity as far as it can go Start TEOAE recording see the user manual As the test cavity do...

Page 27: ...hones appear on the screen Fig 14 Fig 14 Frequency response calibration When the test is over the result should be REFER There must be no emission for all frequencies Fig 15 Fig 15 Result of DPAOE che...

Page 28: ...h the system Checking with the probe out of the test cavity leads to wrong results The check is performed in a special OAE probe check mode In this mode the comparison of OAE probe responses with alre...

Page 29: ...eral pairs of bars The probe check is performed on several frequencies each bar pair for each probe loudspeaker corresponds to one frequency If the colour of bars is green the OAE probe is operable If...

Page 30: ...t touch the OAE probe cable and try to avoid its casual vibrations Fig 19 Saving specifications of a new OAE probe Then press Close The Remember this probe as a new one message will appear Fig 20 Fig...

Page 31: ...patient The sound level meter microphone is positioned at the proposed head center The room acoustics should conform to the requirements for free field audiometry The room and its interior should pro...

Page 32: ...aural 0 DEMO for monaural listening when one ear is tested in free field the other must be occluded for instance with a special protection headphone or audiometric earphone with masking noise introduc...

Page 33: ...rd Loudspeaker and serial number of loudspeaker in its name in parentheses Press OK and exit the Neuro Audio NET program After that the newly created calibration file will be used by the program whene...

Page 34: ...c or 70 alcohol 0 5 chlorohexidine 3 If any dangerous viruses or skin diseases are suspected use Aldehydes Cidex etc or chlorinates Diversol BX 4 Remove disinfectant with a dry cloth 4 5 Lifetime The...

Page 35: ...tions The battery contains the poisonous hydride of heavy metals and should be disposed in special places 7 Acceptance Delivery Set and Package Data The Neuro Audio digital system for auditory EP OAE...

Page 36: ...the period from reclamation submission up to repair completion see section 9 Reclamation 8 3 The warranty is voided in the following cases if the rules of operation storage transportation and assembly...

Page 37: ...e the reasons and circumstances preceding fault detection in addition it is recommended to attach test report exam data photos and other materials that allow solving the problem as soon as possible 9...

Page 38: ...e than 0 5 V High pass filter 0 01 5000 Hz Low pass filter 10 10000 Hz On off notch filter 50 or 60 Hz switchable not less than 40 dB Common mode rejection not less than 100 dB Gain 21 20832 Auditory...

Page 39: ...kHz bandwidth 1 2 octave Stimulus polarity condensation rarefaction alternating Frequency characteristics of masking noise white noise 0 02 10000 Hz Noise masking intensity 0 127 dB SPL stimulus rela...

Page 40: ...amplifier unit 190 140 50 mm 235 63 166 mm Weight Neuro Audio electronic unit bone conduction amplifier unit 0 9 kg 0 2 kg Climatic conditions Operating conditions temperature relative humidity atmosp...

Page 41: ...ic Compatibility Electromagnetic compatibility EMC is ensured by compliance with EN 60601 1 2 2015 requirements The system is intended for operation in the electromagnetic environment conditions which...

Page 42: ...038 1 1 1 Holder mount NS006200 002 1 1 1 Patient button NS028201 009 020 1 7 2 USB hub1 DS042 02 01 001 000 1 Accessories for OAE Studies OAE probe OAE 02 2 NS006355 003 01 1 1 OAE probe tip NS006221...

Page 43: ...1 Cable for disposable electrode connection Alligator clip touch proof blue 1 m NS990103 027 06 10 1 1 Disposable surface electrode 2 F 9049 FIAB Italy 100 100 Auditory stimulators and accessories Aud...

Page 44: ...r Manual AU999 01 003 000 1 1 1 1 OAE Probes OAE 02 OAE 03 OAE 04 and aScreen Probe guidelines GL032 03 001 001 1 1 EABR Test guidelines GL032 04 001 000 1 1 1 1 VEMP Vestibular Evoked Myogenic Potent...

Page 45: ...es for EMG and EP Studies technical manual NS990998 048 01 1 pack 1 pack EEP NS990106 072 01 10 5 pcs 5 pcs 1234 NS990106 049 Y adapter NS006103 019 1 1 Auditory stimulator headphones TDH 39 with earc...

Page 46: ...PTA Study Patient button NS028201 009 02 1 1 1 7 2 USB hub 2 DS042 02 01 001 000 1 1 1 Equipment for ECochG Study Electrode for electrocochleography TED001 SPES MEDICA S R L Italy 10 10 10 10 Insert...

Page 47: ...guidance RF emissions CISPR 11 2009 Group 1 The digital system uses RF energy only for its internal function Therefore its RF emissions are very low and not likely to cause any interference in nearby...

Page 48: ...kV 2 Mains power quality should be that of typical commercial or hospital environment 2 kV common mode 0 5kV 1 kV 2kV 2 Voltage dips IEC 61000 4 11 2004 0 UT during 0 5 period at 0 45 90 135 180 225...

Page 49: ...nication equipment IEC 61000 4 3 2006 Band MHz Immunity level V m The use of portable and mobile RF communications equipment can adversely affect the recording do not use an operating cellular phone w...

Page 50: ...y of transmitter d m P d 17 1 in the band from 150 kHz up to 80 MHz P d 17 1 in the band from 80 up to 800 MHz P d 33 2 in the band from 800 MHz up to 2 5 GHz 0 01 0 117 0 117 0 233 0 1 0 369 0 369 0...

Page 51: ...ith the internal stimulators The plug soldering and trig pulse parameters are given in Fig 22 If the trig in is used then the negative polarity TTL pulse with not less than 5 s duration must be at the...

Page 52: ...n start from the external stimulator 4 In the stimulation settings it is recommended to set those stimulus parameters which the external stimulator has as these particular values are saved together wi...

Page 53: ...timulator checkbox in the stimulation parameters settings 5 In the stimulation settings it is recommended to set those stimulus parameters which the external stimulator has as these particular values...

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