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Description and Operation

- mark of conformance to Russian standards requirements.

- mark of conformance to 93/42/EEC “Concerning Medical Devices”
directive.

- mark of conformance to 2002/96/EC “On waste electrical and electronic
equipment (WEEE)” directive.

Содержание Neuro-Audio-Screen

Страница 1: ...Technical Manual Neuro Audio Screen Neuro Audio Screen OAE Portable All in One ABR DPOAE TEOAE Hearing Screening Systems TM057 02 002 000 14 11 2012...

Страница 2: ...Neurosoft Ltd 2013 5 Voronin str Ivanovo 153032 Russia P O Box 10 Ivanovo 153000 Russia Phone 7 4932 24 04 34 Fax 7 4932 24 04 35 E mail com neurosoft ru Internet www neurosoft ru...

Страница 3: ...Parameters 22 5 1 3 Connectors 24 5 2 Turning on 25 5 3 Rechargeable Battery Charge 25 5 4 Entering of Personal Data of New Patient Selection of Patient from Database Removal of Patient Data 29 5 5 Pa...

Страница 4: ...oning Check Using Test Cavity 85 9 5 OAE Probe Check 86 9 6 Conservation 90 10 Packing and Transportation 90 11 Storage Regulations 91 12 Utilization of Neuro Audio Screen and Neuro Audio Screen OAE 9...

Страница 5: ...sing otoacoustic emission and auditory brainstem response techniques The manual is the document certifying the technical parameters of the products which are guaranteed by the manufacturer Read carefu...

Страница 6: ...y brainstem response BERA brainstem evoked response audiometry DPOAE distortion product evoked otoacoustic emission IHC inner hair cells LCD liquid crystal display OAE otoacoustic emission OHC outer h...

Страница 7: ...he instrument indoors only Do not expose this device or its accessories to temperatures below 5 C or above 40 C or to relative humidity of more than 90 Do not drop or otherwise cause undue impact to t...

Страница 8: ...Screen and Neuro Audio Screen OAE screening systems can result in the device failure and the rechargeable battery outage Do not connect the printer power supply unit to Neuro Audio Screen and Neuro A...

Страница 9: ...t evoked otoacoustic emission TEOAE is an acoustic signal that can be detected in the ear canal of a person with normal outer hair cell OHC function subsequent to stimulation of the auditory system wi...

Страница 10: ...tem response ABR is an electrical signal recorded from the electrodes placed on the head of a patient with the normally functioning organs of hearing including the auditory nerve and projection areas...

Страница 11: ...e 400 5000 Hz Stimulus intensity range 50 90 dB SPL Stimulus spectrum flatness in the frequency range 0 5 2 5 kHz in the frequency range 0 5 5 kHz not more than 10 dB not more than 20 dB Noise level i...

Страница 12: ...tion in the electromagnetic environment conditions which are specified in the appendix 1 Electromagnetic Emission and Immunity Portable and mobile RF communication equipment may affect the system work...

Страница 13: ...on 13 mark of conformance to Russian standards requirements mark of conformance to 93 42 EEC Concerning Medical Devices directive mark of conformance to 2002 96 EC On waste electrical and electronic e...

Страница 14: ...External power supply 9 V Fig 1 In the OAE test mode the central processor module CPM generates the test signal in a digital form and transfers it to the digital to analogue converter DAC The DAC conv...

Страница 15: ...he device operation keeps the settings and test results displays the test procedure test results service information using the LCD display To transfer the results to the computer or thermal printer an...

Страница 16: ...ery Set Number pcs Name Document code or main specifications 1 2 Neuro Audio Screen electronic unit NSFT 057201 015 1 Neuro Audio Screen OAE electronic unit NSFT 057201 016 1 Power supply unit PSU 9 N...

Страница 17: ...uld be permitted in the country 2 OAE probe NSFT 006355 003 01 is supplied with probe tip NSFT 006221 001 and OAE probe NSFT 006355 003 00 is supplied with probe tip ER10D RPT Table 3 Additional Equip...

Страница 18: ...mmendations stated in section 7 2 1 1 Monitor LCD 19 1 1 Printer for personal computer Laser or jet 1 1 Printer for electronic unit CUSTOM S Print BT Citizen CMP10 2 Bluetooth 1 1 Note 1 The accessori...

Страница 19: ...ages 4 2 Room Selection and Placement The Neuro Audio Screen and Neuro Audio Screen OAE screening systems are portable devices that is why its exploitation is allowed in any rooms of patient care inst...

Страница 20: ...sitivity date and time Set the report type The detailed procedure is described in section 6 5 System Settings Step 5 Insert the ear tip deeply into the patient s ear canal to obtain a seal The order o...

Страница 21: ...e saving of the exams the reviewing of the test results etc The function of each button varies depending on the current operation mode the exam the review etc and is displayed in the text line straigh...

Страница 22: ...g of the menu the settings the exam procedure and results the additional information battery condition free space Bluetooth mode on off and the text line the function of multifunctional buttons 2 The...

Страница 23: ...ry as a sign with three segments At the completely charged rechargeable battery all the three segments are displayed During the battery discharge the number of the displayed segments lessens 2 The ico...

Страница 24: ...e is absent in Neuro Audio Screen OAE 2 The connector for OAE probe 3 The connector for the telephones attachment is absent in Neuro Audio Screen OAE The telephones are not included in the base delive...

Страница 25: ...s switched off at the buttons release see the section Troubleshooting If the rechargeable battery is absent it is necessary to connect the power supply unit included in the delivery set It is prohibit...

Страница 26: ...is defined only by the indicator located on the front panel After the charge process finishing the indicator on the front device panel should glow green what means the successful completion of the cha...

Страница 27: ...servicing The charge and the discharge are the most important wear out factors As far as the Li ion battery have no memory effect it is allowed to charge discharge the battery at any charge level Thou...

Страница 28: ...ttery Li ion battery should be stored charged If Li ion battery is kept with 2 75 V voltage and lower for three months or more the battery capacity will be lowered greatly Besides the corrosion of the...

Страница 29: ...onsidered the one whose per sonal data are not saved in the device memory it is necessary to enter her his data to the device To do this select the item Patient of the main menu Fig 8 using the arrow...

Страница 30: ...ering for example 30 12 05 press the Close button If there are any special data concerning a patient you would like to save name of a doctor performing a exam possible causes of a disease etc than cho...

Страница 31: ...box with the request concerning the removal of the entire patient s data will appear on the screen To confirm the removal press Yes button to cancel the removal press No button In the result of this...

Страница 32: ...wake a newborn up and make her him nervous In this case it is more preferable to use mushroom shapes ear tips At the application of the mushroom shapes ear tip pay attention to the ear tip insertion I...

Страница 33: ...panel To register TEOAE in newborns it is necessary to calm a baby down and make her him keep quiet and calm The external ear canal of the newborns can close during the OAE probe insertion To prevent...

Страница 34: ...g the initial sharp peaks is characteristic for this condition In this case the OAE probe should be reinstalled The Fig 15 b shows the impact of the excessive noise to the stimulus shape The cause can...

Страница 35: ...ng a short term check the device detects that the OAE probe is fitted bad the Check probe fitting message will appear above the stimulus shape curve In this case it is necessary to press the Close fun...

Страница 36: ...rmation is displayed here The number of the averaged responses number of artifacts is located against the Stim Art label The big number of artifacts indicates either the strong external acoustic noise...

Страница 37: ...of averaging 1000 by default OAE is not detected the test is stopped and the REFER signature appears on the information panel After the test termination you can print the result on the wireless therm...

Страница 38: ...tion when the probe tip is fit against the wall of the ear canal or when the canal is closed for example by the impacted cerumen If the device considers that the OAE probe is fitted correctly it will...

Страница 39: ...PASS or REFER signature appears on the information panel opposite the corresponding frequency and the device continues the testing on the next frequency As soon as all the frequencies are tested the...

Страница 40: ...mmended to perform the testing at the disconnected external power supply of the device and away from the electromagnetic noise sources such as the electric wiring and the electrical appliances The pla...

Страница 41: ...tor The OAE probe application is analogous to the one described in section 5 5 Patient Preparation for OAE Test When using the insert earphones please make sure that the front tubes are clean and the...

Страница 42: ...rawn If all the three circles are colored green it means that the impedance val ues for all the electrodes are within the norm and the next stage will be automatically started in several seconds At th...

Страница 43: ...isplayed in the top of the window The color gamma depends on the selected ear the blue color is for the left ear and the red one is for the right one The displaying scale can be changed in the limited...

Страница 44: ...atmosphere or after the probe resetting When the values of all the calculated parameters exceed the liminal ones the regis tration is stopped and the signature indicating the test result PASS appears...

Страница 45: ...is represented Fig 24 If the check box is checked it means that the test is passed the result is positive in case the check box is unchecked the test is failed The first figure indicates the sequence...

Страница 46: ...scale using the up and down arrow buttons The View button serves for the switching between the modes of the curves displaying on the screen There are two modes of the displaying sum averaged curve Fi...

Страница 47: ...y After the printing termination the connection deactivates that is why there is no need to change Bluetooth settings in the Settings menu If you want to review print the results of other test choose...

Страница 48: ...tected from the direct sunlight 5 10 2 Removal of Test Results This paragraph describes the way of removal of ONE patient s test results To delete ALL the results of ALL tests and patient s personal d...

Страница 49: ...following components 1 Name of a patient if it was entered 2 Date of birth if it was entered 3 Date of the test performing based on the settings of the internal clock If the clock is set correctly the...

Страница 50: ...s given 12 Analysis table column by frequencies in which the OAE presence absence on the given frequency is shown The symbol means the OAE presence and its absence denotes the OAE missing 13 Stimulus...

Страница 51: ...ies in kHz 8 Column with the results by frequencies If the emission on the given frequency is presented it is indicated by the symbol if not by symbol If the considerable noise or nonstable OAE probe...

Страница 52: ...f birth if it was entered 3 Date of the test performing based on the settings of the internal clocks If the clock is set correctly the date in the report will also be correct 4 Ear right left 5 Test r...

Страница 53: ...the settings menu using down ar row button and press the Select button After that press Standard button At that the dialog box for the conforming of the standard settings application for OAE and ABR...

Страница 54: ...55 Noise level dB SPL 25 SNR pass criteria dB 8 Frequencies for pass 50 Point time s 5 The standard settings for ABR test Template Screening 60 dB Intensity dB nHL 60 Stim rate Hz 92 Rejection thresh...

Страница 55: ...ect the required type of the report To exit this menu press Close button The Bluetooth setting activates deactivates this type of the wireless connection used for the data transfer to the personal com...

Страница 56: ...equencies from 1 up to 4 kHz and one frequency 5 kHz 3 any three frequencies 4 any four frequencies 5 any five frequencies Stim rate Hz Range from 49 up to 66 Number of frequencies 5 1 0 5 0 5 frequen...

Страница 57: ...e dialog box with the request concerning the default settings setup will appear on the screen Press Yes button to set them or No button to cancel If you press Yes button the standard settings will be...

Страница 58: ...ew template and set it up If you want to remove the template press Delete button Fig 34 DPOAE test parameters setting To change the settings in your template select the required setting using up and d...

Страница 59: ...with the request concerning the default settings setup will appear on the screen Press Yes button to set them or No button to cancel If you press Yes button the standard settings will be set only for...

Страница 60: ...buttons left 1 and right 1 or by 10 units by pressing 10 and 10 buttons If you want to set the standard settings press the Standard button The dialog box with the request concerning the default setti...

Страница 61: ...the System settings item using up and down arrow buttons and press Change button The window represented in the Fig 36 will appear on the screen Fig 36 The window of system parameters setting The Sensi...

Страница 62: ...technical manual to learn the printer address For example for SPRINT printers at the switching on the power supply it is necessary to press and hold the control button till the page with the printer...

Страница 63: ...setting window will display on the screen The time is entered in the same way as date in the format it is represented in the menu HH MM SS hour minutes seconds The hour value is entered in 0 24 range...

Страница 64: ...ress Clear button You will automatically return to editing window of system settings In this window press Close button and answer Yes to the question concerning the necessity of changes saving The scr...

Страница 65: ...appear To save the changes press Yes button to exit without saving of the changes press No button 7 Data Exchange with Computer 7 1 Screening System Connection to Computer To exchange the data with Ne...

Страница 66: ...press it with the right mouse button and in the appeared menu choose the Join a Personal Area Network item Fig 39 Fig 39 Device connection with the computer Step 1 Step 2 If you already set the conne...

Страница 67: ...ox and press Next button Fig 41 Fig 41 Device connection with the computer Step 3 Step 4 The computer will perform searching and in some time will show the list of the detected devices Choose Neuro Au...

Страница 68: ...umenta tion and enter the passkey 12345 Fig 43 Press Next button Fig 43 Device connection with the computer Step 5 Step 6 The computer will exchange the passkeys with the screening system and will inf...

Страница 69: ...Windows XP Vista 7 operating system For the software setup there should be 1 Gb of free hard disk space and not less than 20 Mb of free hard disk space for the exam archive In case of operation under...

Страница 70: ...allation the shortcuts for Neuro Audio Screen Manager start will appear on the desktop and in the Start menu You can use any of them After the program start the main window will appear on the screen F...

Страница 71: ...test passing by TEOAE left and right ears DPOAE left and right ears and ABR left and right ears techniques is displayed The list of exams is also represented as the table with the following areas the...

Страница 72: ...f patients and exams from the device it is required to activate Bluetooth on it and make the connection as it was described above After that it is possible to receive the list of patients Press button...

Страница 73: ...x asking where the information should be saved will appear on the screen Fig 48 Fig 48 Folder selection After the folder selection the information saving will occur and the list of the selected patien...

Страница 74: ...file se lection will appear on the screen Fig 50 Fig 50 Database opening from the disk Select the folder where the information about the patients and exams is kept pa cients xml file should be availa...

Страница 75: ...m the report uncheck the checkboxes opposite them in the exam list before the report generation 7 2 4 Operation with Patients List One of the main tasks of Neuro Audio Screen manager software is the c...

Страница 76: ...with the mouse Fig 54 Fig 54 Patient removal from the list Press Delete patient button or Del key Confirm a patient removal in the ap peared dialog box Fig 55 by pressing OK button or deny the remova...

Страница 77: ...e transferred to the device It is performed with the use of Send changes to device button Bluetooth should be activated on the device and the connection should be established If at that moment the rec...

Страница 78: ...program language open Service menu and choose Se lect Language item The Select Language dialog box will appear on the screen Fig 58 Fig 58 Selection of program interface language Choose the required l...

Страница 79: ...ord the further operation will be possible only after the correct password entering 7 2 6 Firmware Updating Using the manager you can update the device firmware To do this switch on the de vice in the...

Страница 80: ...number which can be updated using the function of firmware update After the updating run the program checks the availability of this key In case the key is not detected or does not correspond to the d...

Страница 81: ...uring the updating it is prohibited to switch off the computer or disconnect from it If the updating file is damaged the error message will appear on the screen Fig 64 Fig 64 Incorrect updating file T...

Страница 82: ...ery The rechargeable battery is discharged The battery discharge limiting circuit activates in the screening system Connect the power supply unit and charge the rechargeable battery The time of the on...

Страница 83: ...this procedure results in the electronic unit opening and you may loose the warranty if you address to other service centers or open the unit yourself When you start any test the Memory is full error...

Страница 84: ...d technical manuals or typical rules When detecting the troubles it is recommended to use the information given in the section 8 Troubleshooting The screening system should be serviced while the opera...

Страница 85: ...and A B traces should be lesser than 0 Fig 65 Fig 65 The screen view after TEOAE check finishing If it is not so make sure it is quiet in the room the OAE probe sensitivity is specified correctly see...

Страница 86: ...EFER The emission should lack for all frequencies Fig 67 Fig 67 The screen view after DPOAE test finishing After the test finishing close the test When Save changes message box appears on the screen p...

Страница 87: ...n lead to loss of data concerning OAE probe specifications and the check of this probe will become impossible The given button is used only for the recording of specifications of new probe at the repl...

Страница 88: ...E probe check is performed on several frequencies each bar corresponds to one frequency If the bar color is green the OAE probe is operable in case the bar is red the probe is faulty Fig 70 Fig 70 The...

Страница 89: ...E probe The detailed instructions on cleaning and disinfection of the OAE probe and the removable OAE probe tip are stated in OAE Probe OAE 02 technical manual After OAE probe replacement it is requir...

Страница 90: ...he screening system components including accessories and operational documentation should be packed in separate plastic sachets and then placed in a manufacturer package 10 Packing and Transportation...

Страница 91: ...which can cause the corrosion The screening systems should be put on the shelves not more than in four lines The rechargeable battery should be 50 charged It is recommended to recharge it every 9 12 m...

Страница 92: ...ate The screening system is delivered to the customer ____________________________ date Screening system was handed ___________________________________________ signature Screening system was accepted...

Страница 93: ...d pastes The warranty period can be prolonged for period from reclamation submission up to repair completion chapters 18 19 14 3 Operation of guarantee commitment is stopped if the rules of operation...

Страница 94: ...erial number of the stimulator see chapter 13 of the present manual or the sys tem marking the copy of chapter 15 of this manual or the number and the date of the invoice or other document confirming...

Страница 95: ...Reclamation Data 95 Table 6 Reclamation Data The date of failure or trouble appearance Brief description of the trouble The date of reclamation sending Taken measures Note...

Страница 96: ...ng Systems Technical Manual 96 19 Repair Data Table 7 Repair Data Date Position name signature of person Name and code of faulty unit Degree of imperfectio n completio n of repair arrival Name of repa...

Страница 97: ...mpliance Electromagnetic environment guidance RF emissions according to ISPR 11 Group 1 The system uses RF energy only for its internal function Therefore its RF emissions are very low and are not lik...

Страница 98: ...ns power quality should be that of a typical commercial or hospital environment 1 kV differential mode 1 kV Surge by IEC 61000 4 5 2 kV common mode 2 kV Mains power quality should be that of a typical...

Страница 99: ...ned by an electromagnetic site survey 1 should be less than the compliance level in each frequency range 2 Interference may occur in the vicinity of equipment marked with the following symbol 1 Field...

Страница 100: ...ncy of transmitter m Rated maximum output power of transmitter W 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 23 2 in the band from 800 MHz up to 2 5 G...

Страница 101: ...5 ear 1 testResult 0 abr dpoae chk_631153848 date 03 03 2008 16 25 ear 1 testResult 0 dpoae teoae chk_1204550744 date 03 03 2008 16 25 ear 1 testResult 0 teoae left right abr chk_631153848 date 03 03...

Страница 102: ...lt 0 where chk_nnnnnnnnn a unique identificator of the exam with the chk_ prefix date the date and the time of the exam performing ear the ear 0 right 1 left testResult the result of the test 0 refer...

Страница 103: ...r Number of averagings integer artifactNumber Number of artifacts integer samplingFreq Sampling rate in Hz integer stimulIntensity Stimulus intensity real number impP Impedance real number impM Impeda...

Страница 104: ...es integer for the current version of the device is always equal to 12 sizeOffreqs1 Number of frequencies F1 integer freqs1 Frequencies of study F1 array of real numbers number of points sizeOffreqs1...

Страница 105: ...on date Date and time of the exam performing Format dd mm yyyy hh mm ear Ear for the exam performing 0 right 1 left integer testResult Test result 0 refer 1 pass integer averagesNumber Number of avera...

Страница 106: ...teriaIndex Number of frequencies for OAE separation 0 2 frequencies from 1 up to 4 kHz and additionally 5 kHz 1 any 3 frequencies 2 any 4 frequencies 3 all frequencies integer reproductivity Reproduci...

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