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Operating Instructions MB 11

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1. i i 3 ae General Power Driver Details Power Management DYD CD ROM drives Floppy disk controllers p gt USB Root Hub Floppy disk drives IDE ATAJATAPI controllers gt Keyboards O the computer to turn off this device to save power Allow this device to bring the computer out of standby Mice and other pointing devices Monitors 8 Network adapters 41 9 Ports COM amp LPT Processors SCSI and RAID controllers Sound video and game controllers System devices Universal Serial Bus controllers 2 Intel r 8280144 USB Universal Host Controller USB Root Hub Figure 6 Figure 7 Cancel If there are more than one listed USB Root Hubs please repeat the procedure as de scribed above and take out the check mark if preselected Do not allow the computer to turn off this device to save power GEBA_8100496_MB11_BERAphone_e_3 18_14b 9 8100496 3 07 14 M Operating Instructions MB 11 MAICO 4 3 2 Change Power Options To change power options select Run within the START column type powercfg cpl and confirm Run E Type the name of a program Folder document or F Internet resource and Windows will open it For you Open powerctg cpl Cancel Browse Figure 8 Figure 9 If you use a desktop computer select Home Office Desk within the Power
2. File Settings About MAICO Accepted 2400 Artifacts 28 Artifact limit 20 gt 10 20 uY wo i a a Ina Anne Uinta a e a ated lt a e REARS Enea WE an Aa A uw z 0 Amplitude 20 0 4 8 12 16 20 24 28 32 36 40 0 5 uv Time ms a 10dBnHL 20dBnHL 30dBnHL 40dBnHL 50dBnHL 60dBnHL 250 gt gee IRL RLV III PLA LLP PLING PLO PPAR PAPO Vin PAPE W a 250 NIGI 7 a ae 2005 5 10 5 25 30 35 40 _ advanced Time m Stimulus Level 60 dBnHL Click Time Step Stimulus Stee Bact e M MB 11 Classic with EAR 34 s n 0000000 Figure 37 MB 11 program result Time Step Stimulus 5 29 2012 4 GEBA_8100496_MB11_BERAphone_e_3 18_14b 49 8100496 3 07 14 M MAICO Operating Instructions MB 11 8 1 3 Advanced display Time Step Sumulus Test The advanced display mode can be entered by clicking on the box advanced on the left side of the test screen This test screen contains additional information and features This mode is available for the current test result as well as for the stored data Figure 58 and 59 display the test result shown in chapter 8 1 2 figure 59 in the advanced display format During the test the single measurement sweeps are stored alternatively in the A and B Buffer It is possible to display data within the A and B Buffers separately by selecting the A B func tion located at the left of the test screen When
3. V should be visible Other options and displays shown in this Standard ABR screen are explained in detail in chapter 8 1 2 of this manual M MB11 Miller Norma Born 5 9 2012 Age 20 day s E 5 x Accepted 2400 Artifacts 9 File Settings About MAICO Artifact limit 20 20 pV Amplitude 20 0 4 8 12 16 20 24 28 32 36 40 0 5 uY Time ms EEG uV AEP jn Right Ear _ advanced i Trevis j j 5 2 Stimulus Level 60 dBnHL Click Standard ABR Other Ear Start Measurement Pause Quit MB 11 Classic with EAR 34 s n 0000000 5 29 2012 Figure 42 MB 11 program test screen Standard ABR GEBA_8100496_MB11_BERAphone_e_3 18_14b 51 8100496 3 07 14 M Operating Instructions MB 11 MAICO 9 Care and maintenance of the instrument 9 1 Cleaning the MB 11 BERAphone The BERAphone s steel electrodes and the earphone are designed to make direct con tact with the baby s skin Assuming intact skin on the baby the instrument is consid ered non critical according to the CDC guidelines for minimizing cross intection mean ing that the instrument contacts the patient only externally on intact skin Therefore sterilization is not required However the instrument must be cleaned and disintected with a medical or hospital grade disinfectant prior to re use Individual manufacturer s instruction should be followed for use of this disinfecting agent to
4. MAICO 12 2 Sensitivity and specificity of the Auditory Steady State algorithm For a successful universal newborn hearing screening UNHS program it is essential to have a high rate of detection of severe hearing losses and a low referral rate of babies with normal hearing For better understanding the terms Sensitivity and Specificity are explained below in general and also specitically related to the ASSR algorithm which is implemented in the MB 11 Sensitivity Percentage of positive results Refer Fail for newborns with severe hearing disorder Specificity Percentage of negative results Pass for normal hearing newborns The ASSR regarding specificity Clinical investigations of newborns in a hearing screening program do normally not produce data from which an unbiased estimate of the specificity can be calculated Therefore the precise value of the Specificity cannot be given Besides Hearing Loss restless babies during the test or electrical distorting fields in the test facility can lower the Speciticity Regarding sensitivity and critical test value One way to assess the sensitivity is to test a high number of babies with known hearing loss However mostly a sufficient number of babies with known hearing loss is not available Therefore here another method was used Due to the high stimulus repetition rate of 93 Hz a periodic signal ASS re sponse will be generated from the audi tory system see figure 6
5. MAICO Diagnostic GmbH Operating Instructions MB 11 MAICO Diagnostic GmbH Salzufer 13 14 D 10587 BERLIN Tel 49 30 70714650 Fax 49 30 70714699 MAICO Table of Contents 1 Introduction 2 Important safety instructions 3 Description 3 1 Auditory Brainstem Response ABR audiometry 3 2 The BERAphone 3 3 Automatic Screening with Auditory Steady State Algorithm 4 Installation and Settings 4 1 USB Specitications 4 2 Installation of MB 11 Software 4 3 Computer Settings for optimal performance 4 3 1 Deactivate save power USB hubs 4 3 2 Change Power Options 4 3 3 Change visual effects 4 3 4 Change Display Properties 4 3 5 BIOS Setup 5 Getting started 5 1 Unpacking your instrument 5 2 Preparing the MB 11 for use 5 3 Getting familiar with the MB 11 BERAphone 5 4 Starting the software and menu 5 4 1 Menu File 5 4 2 Menu Settings 5 4 3 Menu About 5 5 Operation with mouse and keyboard or touch screen 5 6 Registry of new patient data 5 7 Loading of stored patient data 5 8 Working with a Today s list 6 Automatic testing in the ABR screening mode 6 1 Preparing the baby for measurements 6 2 Placement of the BERAphone 6 3 Performing the screening test 6 3 1 Impedance Test 6 3 2 The signal quality control 6 3 3 Advanced display mode EEG Display 6 3 4 The function buttons 6 3 5 Test result Pass 6 3 6 Test result Refer 6 3 7 Test result Abort 7 T
6. ets and relaxes The stimulus continues when the screening is Paused When the baby is quiet Resume the test GEBA_8100496_MB11_BERAphone_e_3 18_14b 70 8100496 3 07 14 M Operating Instructions MB 11 MAICO 5 Before applying the BERAphone to the baby s skin make sure that the electrodes and ear cushion are completely dry after using the disinfectant wipe to clean the de vice The disinfectant is not good for the baby s skin and can also affect the quality of the recording if the electrodes are still wet 6 When using the MB 11 BERAphone it is easier to monitor the correct positioning of the BERAphone on the baby s head when the screener is positioned looking in to the face of the baby Itis more challenging to achieve good electrode and ear phone placement on the baby when the screener is positioned looking at the back of the baby s head 7 During screening be watchful that the ear cushion surrounding the baby s ear is constantly in contact with the baby s head around its entire perimeter Gaps be tween the ear cushion and the baby s skin will allow some of the stimulus intensity to leak out of the earphone cavity reducing the volume of the stimulus reaching the baby s ear 8 Screenings can be successfully performed even in relatively noisy places like a NICU However a quieter test environment is desirable when it can be achieved Aware ness of the noise level in the test room and attempts to control it w
7. ry PC devices such as those with external power supply like USB Units printers and local area network cables LAN If it is necessary to use accessory devices while you operate in the battery mode ensure a separate continuous and sufficient grounding of your PC Connecting plugs Connection Specification USB socket USB 1 1 max 400 mA w 2 Figure 45 Connector of MB 11 GEBA_8100496_MB11_BERAphone_e_3 18_14b 58 8100496 3 07 14 M Operating Instructions MB 11 MAICO 12 Scientific Background Information 12 1 CE Chirp Stimulus The stimulus for an ABR based newborn hearing screening should generate auditory evoked brainstem responses with an amplitude as great as possible at the level of 35 dB HL High response amplitudes allow a fast objective detection with high specificity and short measuring time Up to now in the field of hearing screening the standard click was used as stimulus The standard click is generated by delivering a short rectangular electrical impulse to a transducer This click generates a traveling wave along the basilar membrane The trav eling wave runs from the basal part of the cochlea along the basilar membrane to the tip of the cochlea apex Hereby it excites each of the frequency areas of the cochlea starting with high frequency part and ending with the low frequency part The velocity of the traveling wave is the greatest at the basal part of the cochlea and slows expo nentially t
8. 1 Carrying bag 1 bottle electrode gel 1 USB drive with MB 11 software and training video 1 Operating instructions 1 Short manual Optional Accessories Laptop or Conventional PC if not user supplied on request Electrode gel bottle 8111433 Stainless steel electrode 3 pieces 8001006 Gel protection for electrodes 3 pieces 8002638 Stainless steel electrode for pre matures extra long 8111433 GEBA_8100496_MB11_BERAphone_e_3 18_14b 15 8100496 3 07 14 M Operating Instructions MB 11 MAICO Ear cushion 8010943 Label Printer 8110985 Roll of printer labels 8110477 GEBA_8100496_MB11_BERAphone_e_3 18_14b 16 8100496 3 07 14 M Operating Instructions MB 11 MAICO 5 2 Preparing the MB 11 for use The MB 11 unit is supplied in the Transducer Interface Box that is connected with the BERAphone through a non removable cable A USB cable connects the MB 11 with a USB port of a Notebook or desktop computer The MB 11 s power is directly supplied through the computer via the USB port No ex ternal power supply is needed This makes the MB 11 BERAphone easy and safe to use D 0 OOO 00 Setting Vertex Electrode Vertex Electrode Handle Ear cushion Ground Electrode Earphone Mastoid Electrode Connecting cable Signal quality indicator Gel protection MB 11 box USB cable Cradle DOO O Figure 18 BERAphone and MB 11 box SSSSOQO VWOAPMSHOWSO 5 3 Getting
9. The statistical test decision is based ona _ comparison of calculated test values from Ae 20 a ast Steady State Response in the measured data with a so called critical the frequency domain test value To perform this calculation the continuously recorded EEG is separated into epochs of one second Only epochs having passed the artefact criterion will be used for further analyzing Each accepted epoch is transformed into the frequency domain by Fast Fourier Transformation FFT In the fre quency domain the evoked response is described by a certain number of spectral har monics as described above Each spectral component is characterized by a phase angel and amplitude of the corresponding sinusoidal wave These data can be displayed as vectors in a polar coordinate system see figure 71A If no response to the stimulus is present the epoch contains only noise If this is the case the vector endpoints in the polar display show a random distribution see figure 71 B 90 A single spectral component B No response C Response present random disribution spectral lines of harmonics grouped together Figure 51 Amplitude and phase angel of the sinusoidal waves corresponding to the spectral lines dis played in the polar coordinate system GEBA_8100496_MB11_BERAphone_e_3 18_14b 64 8100496 3 07 14 M Operating Instructions MB 11 MAICO Calculation of the critical test value The algorithm uses the phase angle a
10. click packet is presented in only 25 ms the patient is not aware of the complex composition but it is still processed with a high level of time precision in the brainstem If the six sound pres sure levels of the click chain are arranged in such a way that the hearing threshold lies within this sound pressure range then a single averaging suffices to objectively de termine the hearing threshold as those clicks below this level of course do not evoke any potential step Stimulus ABR EAEN at i im SL eer eer Sirti kg Srl 2 1000 Figure 33 Stimuli Presentation with Standard ABR and Time Step Stimulus ABR Threshold Detection with the Time Step Stimulus Signal Response on 20 30 40 50 60 dB click no response Eb EEE ESE 10 dB 20 dB 30 dB 40 dB 50 dB 60 dB S ms 0 5 10 15 20 25 30 35 40 Figure 34 Typical ABR Response with the Time Step Stimulus Signal The white bars show the frame within which wave V for each of the evoking clicks is expected Click intensities are located above the corresponding column white bar The step stimulus curves permit a direct reading of the ABR hearing threshold The white bars with the anticipated latency of the relevant wave V are very useful The cen ter of these white bars is set for the timing of the normal latency intensity function and is shifted according to the age of the patient as entered in the patient data GEBA_8100496_MB11_BERAphon
11. o Sons _oves 8 8 4x Type the name of a program folder document or Internet resource and Windows will open it for you Cancel Browse GEBA_8100496_MB11_BERAphone_e_3 18_14b 13 8100496 3 07 14 M Operating Instructions MB 11 MAICO Display Properties 2 Display Properties ea Ea Themes Desktop Screen Saver Appearance Settings Themes Desktop Screen Seven Appearance Settings Screen saver Windows sP 4 None Background D None 7 Browse hiin Gab auswahl kd Settings Preview tume password protect Position Gab Autumn swedar B Azul Color power settings and save energy FAW Bliss i Elin 10 E Customize Desktop i i Power hlystif Cancel Apply i o Cancel Apply 4 3 5 BIOS Setup Because the MB 11 software uses real time and processor intensive algorithms we rec ommend disabling energy saving processor settings in the BIOS like throttling on Intel Pentium or Power Now on AMD Athlon For further details consult the documentation for your main board or ask your local computer dealer Additionally it is recommended to adjust the value of system performance inside the system control to optimal GEBA_8100496_MB11_BERAphone_e_3 18_14b 14 8100496 3 07 14 M Operating Instructions MB 11 MAICO 5 Getting started All Notebooks delivered by MAICO have the correct settings and th
12. 14 M Operating Instructions MB 11 MAICO Annual calibration by a qualified MAICO distributor is recommended Contact your local MAICO representative for scheduling information GEBA_8100496_MB11_BERAphone_e_3 18_14b 70 8100496 3 07 14 M Operating Instructions MB 11 MAICO Specifications are subject to change MAICO Diagnostic GmbH Salzufer 13 14 10587 Berlin Telefon 49 3070 71 46 50 Telefax 49 30 70 71 46 99 E Mail sales maico biz MAICO Internet www maico biz GEBA_8100496_MB11_BERAphone_e_3 18_14b 7 8100496 3 07 14
13. 3 07 14 M Operating Instructions MB 11 MAICO which the customer must purchase from OZ This setting also impacts the Tracking ex port function that is accessed in the Search dialog So there are two ways to create an OZ tracking file One occurs automatically when the OZ tracking function is enabled One is performed through a manual process by exporting based on a manually entered date range entered in the Search dialog Tracking Export area Tracking File Name Allows the user to define the desired name for the tracking file that is saved automatically during data collection Tracking Path Allows the user to define the desired data path for saving of the au tomatically created tracking Tile The Test Settings area allows the user to enable checked or disable unchecked the following features that occur during a measurement Display EEG Screening sets the EEG view as the default when enabled otherwise the quality indicator bar is displayed above the measurement graphic during data collec tion Beep after test enables an audible beep that occurs when a measurement is complete The quality and audibility of the beep may be affected by the specific PC that is used Automatically close test distortion message enabling of this control causes a pop up message regarding test distortion to disappear after 7 seconds When disabled the user must manually close this message t
14. For new users daily inspection inside the gel protector and fixed electrode post is rec ommended If the inspection is routinely showing no indications of gel inside the gel protectors or posts the frequency of this inspection process can be reduced 1 Remove the electrode tip gel protector assemblies from the fixed electrode posts by pulling them straight out 2 Inspect the inside of the gel protectors looking for any sign of electrode gel a The presence of gel inside the gel protector is generally an indication that the screeners are applying an excessive amount of gel to the electrode and or the baby Re instruct the screeners to use only a small amount of gel on the electrode and to reduce the amount of gel used to prepare the baby s skin 3 If gel is observed inside the gel protector remove it from the stainless steel part of the electrode by sliding it off 4 Clean the stainless steel part of the electrode with an alcohol or disinfectant wipe a The stainless steel part of the detached electrode can be autoclaved if desired 5 Clean the gel protector with a disinfectant wipe using a cotton tipped applicator to reach into the cavity to remove any gel inside 6 Allow the gel protector and stainless steel electrode to dry thoroughly and then re assemble 7 Inspect the inside of the fixed electrode post for any sign of electrode gel a Gel inside the fixed electrode post Is an indication that the screeners are applyin
15. GEBA_8100496_MB11_BERAphone_e_3 18_14b 8100496 3 07 14 M Operating Instructions MB 11 MAICO 4 Installation and Settings 4 1 USB Specifications The MB11 is a high powered device that requires a USB port with 500 mA dc current over the Vuss line Passive USB hubs without an internal or sepa rate power supply do not work with the MB 11 BERAphone We recommend using a USB port directly on the PC or notebook computer In most cases these ports allow the use of high powered functions devices If you use additional USB devices on your PC and the MB11 does not work or bothers the function of parallel used USB devices try another USB port to change the USB hub output 4 2 Installation of MB 11 Software Boot the PC and wait until the operating system finishes the start process Please note that the MB11 is only supported by MS Windows 2000 SP4 on up and MS Windows XP SP1 and Windows 7 Professional or Windows 8 Pro The following installation guide bases on the use of MS Windows XP Install the MB 11 Software with the USB driver files Please note that you need admin istration rights for software installation Install the MB 11 software before connecting the MB 11 with the USB port Connect the MB 11 with the USB port of your PC and check that the red LED on the BERAphone lights up If this LED does not light up ensure that your USB port supports high powered USB devices or change the USB port and try again Also see t
16. MB 11 MAICO 10 Trouble shooting If you should find that your instrument is no longer working properly during a test run please check the following points 1 Instrument does not turn on Are all cords plugged in correctly and is the USB plug well fitted in the jack 2 The measurement is running properly but with large regular EEG fluctuations Can an improvement be effected via slightly moving the BERAphone 3 No potential or only unclear potential is registered Listen briefly to the earphone and verify that the stimulus is present Ensure that the EEG was not interrupted by polarization of the electrodes which is easy to identify by extremely smooth curves shown in the EEG section and without any reaction to gentle movements of the MB 11 BERAphone on the baby s head A simple test is to place the MB 11 BERAphone on the inner side of your left arm The Skin of the arm should be prepared with electrode gel and a drop of electrode gel has been put on the electrodes The current variation is determined by the muscle potentials of the arm It is important to test that the muscle potentials of the arm are being rec orded correctly that means contraction yields larger potentials relaxation smaller ones 4 Error Message EEG quality This message appears if there is an enhanced humming noise with a large affect on the measurement quality It is suggested to remove the disturbance source or to test at an other place Click
17. Schemes and select never Turn Off monitor never Turn off hard disk never System on standby never B11 Service_Manual doc Microsoft Word Power Options Properties x Power Schemes Alarms Power Meter Advanced Hibernate l Select the power scheme with the most appropriate settings for thie computer Mote that changing the settings below will modify he selected scheme Power schemes Home Ofhice Desk Save 4s Delete Settings for HomeUffice Desk power scheme 4 Running on batteries When computer is Turn off monitor Tum off hard disks System standby mea __ Figure 10 GEBA_8100496_MB11_BERAphone_e_3 18_14b 10 8100496 3 07 14 M MAICO Operating Instructions MB 11 Select Hibernate within the menu bar and change Hibernate settings to off as shown in the picture 611 Service_Manual doc Microsoft Word a Power Options Properties 2x Power Schemes Alarms Power Meter Advanced Hibernate I When your computer hibernates it stores whatever it has in ky mema on your hard disk and then shuts down When pour computer comes out of hibernation it retums to its previous state Hibernate Disk space for hibernation Free disk space 3 603 MB Disk space required to hibemate n04 ME cancel w Figure 11 If you use a Notebook computer select Portable Laptop within the Power Schemes and select as follows Plugged in
18. an OZ or HiTrack compatible format To do this the OZ or HiTrack Tracking option must be enabled in the Settings Tracking settings menu To export the data click Search on the start screen The Load from Database dialogue appears Fig 49 Choose the data for export using the filter fields set the date range in the Tracking Export area and click the Export button in the Track ing Export area A browser dialog will open al lowing you to type in the name of the export file and the location for storage Be sure that the file name and extension you enter here is the one that OZ or HiTrack will be looking for to merge Figure 49 the data You can limit the list of exported data L029 from Database using the various search filters described in section 5 5 1 GEBA_8100496_MB11_BERAphone_e_3 18_14b 44 8100496 3 07 14 M Operating Instructions MB 11 MAICO 8 Follow up measurements Not available for the MB 11 BERAphone Screener Diagnostic test for the follow up after a REFER result can be enabled by clicking on the box advanced on the lower right of the start screen The start screen now dis plays two additional tests Time Step Stimulus and Standard ABR These two diagnostic tests should only be used by the experienced expert O x File Settings About MAICO MBil Patient New seach Add to Today s List Display Today s List Show Measurem
19. and data with test dates within a defined range The computer s current date and test dates for the patients are used to make this determination Test Result filter Use of the drop down allows you to filter the database for screening test outcomes Pass Refer Abort Not Measured This filter will limit the names of the babies displayed in the list to those that have a test in the database that matches the displayed outcome This filter does not filter for the last or best test result In other words a baby that ultimately passed a screening but at some point had a Refer result will be displayed in the list when the Refer filter is enabled Examiner Screener Name filter Use of this drop down allows you to filter the database for babies screened by a specific screener Number of cases field This read only field displays a count of the number of babies in the database that match the data filtering definitions Data export function The Data Export controls allow you to set a data range using cal endar controls and export patients and tests performed in this date range to an file that can be read in a spreadsheet program such as MS Excel A Windows browser will ap pear to allow you to define the path and filename to which the data will be saved This file can be opened for viewing using a text editor or a spreadsheet application Infor mation contained in the txt file includes ID No as entered by the user Name last First
20. baby to be tested select the ear to be tested right R or left L and start the test by clicking on the button Measure For the test procedure refer to chap ter 6 Names entered into today s list will be erased automatically 48 hours after entry or as soon as a test is initiated However even if a test is not performed the name will re main in the database GEBA_8100496_MB11_BERAphone_e_3 18_14b 28 8100496 3 07 14 M Operating Instructions MB 11 MAICO 6 Automatic testing in the ABR screening mode It is fast and easy to screen with the built in patented automatic Fast Steady State Algorithm Screening means that only a pass or refer result will be displayed at the end of the test The purpose of a screening test is to determine if the newborn patient has the possibility of a significant hearing loss and needs further evaluation Because no judgements or interpretations of the screening results are necessary the test can be easily done by properly trained personnel Additional information and results are available at any time for the doctor or specialist see chapter 5 4 PASS As soon as the indication mark reaches the green area this indicates that the Pass criterion has been met and the result is PASS REFER If no response at the test level of 35 dBnHL is detected the test result is RE FER ABORT If the test is aborted Stop Measurement is pressed during the test the test is
21. familiar with the MB 11 BERAphone The MB 11 BERAphone should be operated in a quiet room so that the examinations are not influenced by outside acoustic noises This may be determined by a person spe cially trained in acoustics and hearing testing such as an audiologist OSHA defines a quiet room for audiometric hearing testing in its guideline OSHA 29 CFR 1910 95 For more information see also chapter 2 Important Safety Instructions GEBA_8100496_MB11_BERAphone_e_3 18_14b 17 8100496 3 07 14 M Operating Instructions MB 11 MAICO 5 4 Starting the software and menu After starting the computer launch the MB11 BERAphone software by clicking the icon MB 11 USB Version on the desktop or direct from the program menu The pro gram launches with the start screen see figure 23 File Settings About MAICO MB11 Patient oowoo Search Add to Today s List Display Today s List Show Measurements Last name First name Born 5 29 2012 male Pat ID Screener rs O female e a MB 11 BERAphone s n 0000000 Figure 19 Start screen of the MB 11 program 5 29 2012 4 Device recognition You can connect up to 3 MB 11 BERAphone devices A pop up window displays the connected instruments If more than one MB 11 is connected you can choose the device you want with a mouse click To change the instrument dur in
22. measure ment now that the baby has quieted down Don t remove the BERAphone when you Stop and Start again as this movement may awaken the baby The point is to start the recording again when the baby is now quiet so that the data quality is better from the beginning of the screening 11 Ultrasound gel is NOT recommended for use with the MB 11 BERAphone It s is chemically different from the recommended electrode gel Parker SignaGel Electrode gel or Sonavelle Electrode gel Additionally it is thinner in viscosity and therefore is more prone to spreading out on the baby s skin perhaps causing the gel from dif ferent electrode sites to merge causing poor recording conditions 12 Switching to a new screening screening device or technology often requires some change in technique Even a seasoned screener will experience higher refer rates as she adjusts to a new device A screener who tests lots of babies will gain experi ence and improve the refer rate quickly Screeners in low volume birthing hospitals who screen babies infrequently will take longer to reach the optimum refer rate In low birth rate hospitals it may be wise to limit the number of individuals performing the screening so that each one gets more practice rather than attempting to have all staff members perform screening GEBA_8100496_MB11_BERAphone_e_3 18_14b 72 8100496 3 07 14 M Operating Instructions MB 11 MAICO APPENDIX B Cleaning Disinfection amp Maint
23. name Sex Birthdate Born Date of test date and time Screener Ear side Test type Mode Result Note If additional fields are completed using the Hi Track tracking feature these fields are not exported through this function In a spreadsheet this Tile should be viewed as a comma delimited file structure Tracking export function The Tracking Export controls allow you to set a data range using calendar controls and export patients and tests performed in this date range to a file that is formatted according to the selection of either OZ or HiTrack set in the Op tions dialog A Windows browser will appear to allow you to define the path and file name to which the data will be saved This file can be merged into HiTrack or OZ You GEBA_8100496_MB11_BERAphone_e_3 18_14b 19 8100496 3 07 14 M Operating Instructions MB 11 MAICO must have purchased these third party databases from HiTrack or OZ and you must fol low their procedures for merging the data in these export files into their databases Print The function implemented by selection of the Print item depends on which Print Mode setting is enabled in the Options dialog Quit Exits the MB 11 program GEBA_8100496_MB11_BERAphone_e_3 18_14b 20 8100496 3 07 14 M Operating Instructions MB 11 MAICO 5 4 2 Menu Settings Save Test settings Saves configurable test set tings as user selected defaults Menu item is
24. new test The function button changes to Stop Measurement Stop Measurement An ongoing test can be aborted by clicking on the button Stop Measurement The pop up window Test aborted because opens The re sult Abort and the reason will be displayed and stored in the database for quality controlled tracking Pause Stops the ongoing test In this case this button changes into Continue and the status indication at the bottom of the screen shows Test in progress Quit Finishes the measurement and returns to the start screen EEG View This shows the EEG during measurements GEBA_8100496_MB11_BERAphone_e_3 18_14b 3 7 8100496 3 07 14 M Operating Instructions MB 11 MAICO 6 3 5 Test result Pass M MB11 Anderson Carl Born 3 21 2012 Age 69 day s i Oj x File Settings About MAICO MB11 _ EEG Pass Criteria O S Pass ft Stimulus Level 35 dBnHL 0 10 20 30 40 50 60 70 100 110 120 130 140 150 160 170 180 80 90 Test Time s Other Ear Start Measurement Pause Quit MB 11 BERAphone s n 0000000 Figure 29 MB 11 program Test result PASS 5 29 2012 4 During the test a small segment of a line is drawn after each 1 second of data collec tion The line displays as blue for a left ear test and red for a right ear test During the test the indication line for pass criteria in the diagram continue
25. off the baby and start again ii Change the power condition of the system That is if you are running on PC battery plug the PC into an outlet Or if you are running on AC power un plug the system printer too and run on PC battery power only See if the rolling artifact in the EEG quiets with this change iii Move to a different location for screening Sometimes moving to a different power outlet in the wall and moving the system and baby across the room can position the system in a part of the room that Is electrically quieter 10 Screening is in progress on a quiet baby with good signal quality green light on BE RAphone but the red or blue data progress line is remaining flat and is not over time trending upward toward the GREEN Pass area a See 7 above b See 9 above c Was the baby initially active when you started the screening and now has be come quiet Sometimes a period of mildly noisy data collection at the begin ning of the recording can prolong the test and delay the progress toward the GEBA_8100496_MB11_BERAphone_e_3 18_14b 71 8100496 3 07 14 M Operating Instructions MB 11 MAICO Pass area even after the baby has become quiet That is the data collection dur ing the quiet time has to overcome the beginning of the data collection that was noisy It may actually save time to Stop the recording in progress if you note that time is going by and it is not trending upward and Start a new
26. on OK and the test will start automatically Alternatively use the keyboard short cut lt Ctrltw gt and the information about the humming noise will disappear after 10 seconds 5 The vertex electrode does not reach the vertex point Depending on the size of the head the position of the vertex electrode can be adapted by rotating the black disc in which the electrode is mounted In case of exceptionally small heads pre mature or NICU babies it may occur that the vertex electrode Is too short to reach the vertex point For this special case an extra long electrode is available and can be ordered as optional accessory See Stainless steel elec trode for pre matures GEBA_8100496_MB11_BERAphone_e_3 18_14b 54 8100496 3 07 14 M Operating Instructions MB 11 MAICO 6 Poor impedance at one or more electrode sites Shift the position of the BERAphone electrode s with poor impedance slightly making sure it is in contact with the area of the skin that was prepared with the electrode gel Remove the BERAphone and massage a little more gel at the site Apply a little more gel onto the electrode itself Use an electrode skin preparation product such as Nuprep or an electrode skin prep pad at the site wipe it off and then re apply gel to the site 7 High artifact poor signal quality during the screening Check the state of the baby A quiet sleeping baby is most conducive to a high quality screening Calm the baby with a pacifie
27. only avail T able for selection from within the Measurement screen eee Reset settings to default Resets configurable a eee test settings to the original defaults Menu item is only mts available for selection from within the Measurement SE screen Settings menu M MB11 unnamed Options Figure 26 This dialog allows you to define a number of user selectable settings The item is only selectable trom within the Main screen The fields in the Software Settings area include Language The program language can be changed to any of the available lan guages that are supported by the fonts installed on your PC Database Path The path for the saving of the MB 11 database can be defined in this field The MB 11 database file includes all patient and test information as well as screener physician screening location and birth hospital entries entered in the List Field Setup area Print Mode This allows the type of printout to be Figure 26 selected Options Enable Label to print to a supported label printer In this mode the best result for both ears will print out by default even if it is not the most current one performed If there is no Pass result for one or both ears then the most current Refer and then Aborted test will print Use the Selected Data Printout setting to override this default printing scheme and choose your desired screening tes
28. screen a measurement is per formed and the number in the box Accepted increases by one GEBA_8100496_MB11_BERAphone_e_3 18_14b 48 8100496 3 07 14 M Operating Instructions MB 11 MAICO If the EEG signal is larger than the Artifact limit this measurement will not be used and the numeric value indicated as Artifacts increases by one If the evoked potentials are large you can change the Artifact limit with the mouse by clicking on the arrow right of the Artifact limit box on the top left of the screen Values between 5 uV and 50 uV are selectable It is important to have a good quality EEG during the test This is especially important when there is a suspected hearing loss or the estimated evoked potentials are low In this case do not increase the artifact threshold but try to calm the baby You could also consider testing the baby at another time when the baby is sleeping Figure 57 shows an example of a test screen for the Time Step Stimulus The analysis time is 40 ms The corresponding wave V responses should occur in the range of the respective white areas Above the white areas are the corresponding click levels Blue stands for the left ear and red for the right ear The magnitude of the curve can be ad justed by changing the Amplitude value from the pull down menu on the left side of the screen Values between 0 1 uV and 1 1 uV are selectable MMB1 1 Miller Norma Born 5 9 2012 Age 20 day s iol x
29. use for the appearance and performance of Windows on this computer You must be logged on as an Administrator to make most of these changes Let Windows choose what s best for my computer M Performance Adjust for best appearance Visual effects processor scheduling memory usage and virtual memory djust for best performance Custom C Animate windows when minimizing and maximizing J Fade or slide menus into view J Fade or slide ToolTips into view C Fade out menu items after clicking O Show shadows under menus Show shadows under mouse pointer Settings J Show translucent selection rectangle O Show window contents while dragging J Slide open combo boxes J Slide taskbar buttons System startup system failure and debugging information M Smooth edges of screen Fonts x Settings User Profiles Desktop settings related to your logon M Startup and Recovery Environment Variables Error Reporting Cancel Cancel Apply Figure 16 Figure 17 4 3 4 Change Display Properties Optional at low power PC To change display properties select Run within the START column type desk cpl and contirm Select Desktop and change background settings to none Select Screen Saver setting to none Display Properties O Properties 2x a Sieen Saver Appearance Settings background plus a set of sounds icons and other elements Clsksnas caneeieses anaaan one cick
30. 00496 3 07 14 M Operating Instructions MB 11 MAICO 1 Introduction Thank you very much for purchasing a quality product from the MAICO family This au tomatic ABR test system MAICO MB 11 BERAphone is manufactured to meet all quali ty and safety requirements and has been certified with the CE symbol according to Medical Directive 93 42 EEC In designing the MAICO MB 11 we placed particular importance in making it a user friendly device meaning its operation is simple and easy to understand And because all functions are software controlled upgrading later to new extended measurement functions will be simple and inexpensive That means that you have invested in a device that will adjust to your future needs If you have problems or have ideas for further improvements please get in touch with us Simply call Your MAICO team GEBA_8100496_MB11_BERAphone_e_3 18_14b 3 8100496 3 07 14 M Operating Instructions MB 11 MAICO 2 Important safety instructions The MAICO MB 11 BERAphone is designed to be used only by skilled personnel Audi ologists Physicians or other trained supervised personnel No person should attempt to use this instrument without the necessary knowledge and training to understand how this equipment is to be properly utilized and interpreted The MAICO MB 11 BERAphone is intended for use on intact external skin around the ears and on the scalp It should not be used if the skin is no
31. 1 The cradle connection provides power for the thermal printer In order to maintain a high level of safety it is necessary to have the instrument and its power supply checked accord ing to the medical electrical safety standard IEC 60601 1 on a yearly basis by a qualified service technician GEBA_8100496_MB11_BERAphone_e_3 18_14b 68 8100496 3 07 14 MAICO M Operating Instructions MB 11 15 Recommended literature Audiometric Interpretation Auditory Disorders Handbook of Clinical Audiology Roesers Audiology Desk Reference Auditory Diagnosis Rapid threshold estimation using the chained stimuli technique for auditory brain stem response measurement 1991 Automated auditory response detection statistical problems with repeated testing Objective Detection of Auditory Steady State Responses Comparison of One Sample and g Sample Tests New efficient Stimuli tor Evoking Frequency Specitic Auditory Steady State Responses New Click like Stimuli for Newborn Hearing Screening GEBA_8100496_MB11_BERAphone_e_3 18_14b A Manual of Basic Audiometry Lloyd Lyle L and Kaplan Harriet Baltimore University Park Press 1980 A Manual for Clinical Evaluation Jerger Susan and James Jerger Boston College Hill Press 1981 Katz Jack Baltimore William amp Wilkins 1994 Roeser Ross J New York Stuttgart Thieme 1996 Silam Shlomo and Silvermann Carol A San Diego London Singular Publishing G
32. 10 117 2005 With the given exact critical test value a sensitivity of nearly 100 99 3 is main tained This is proved by testing noise data no response generated by extensive Monte Carlo Simulations A detailed description of the used ASSR procedure is published by Sturzebecher E Cebulla M and Neumann K Click evoked ABR at high stimulus repeti tion rates for neonatal hearing screening Int J Audiol 42 2 59 70 2003 GEBA_8100496_MB11_BERAphone_e_3 18_14b 65 8100496 3 07 14 M Operating Instructions MB 11 MAICO 13 Warranty Maintenance and After Sales Service The MB 11 BERAphone ABR Screener is guaranteed for 1 year This warranty is ex tended to the original purchaser of the instrument by MAICO through the Distributor from whom it was purchased and covers defects in material and workmanship for a period of one year from date of delivery of the instrument to the original purchaser The MB 11 BERAphone may be repaired only by your dealer or by a service centre rec ommended by your dealer We urgently advise you against attempting to rectify any faults yourself or commissioning non experts to do so In the event of repair during the guarantee period please enclose evidence of purchase with the instrument In order to ensure that your instrument works properly the audiometer should be checked and calibrated at least once a year This check has to be carried out by your dealer When returning the instrument
33. 1_BERAphone_e_3 18_14b 31 8100496 3 07 14 M Operating Instructions MB 11 MAICO e All electrodes must contact the skin well e Care must be taken that the mastoid electrode really remains positioned below the earlobe If there is any doubt carefully move the MB 11 BERAphone to one side and check e The stainless steel electrodes with gel protectors on the MB 11 BERAphone can be reused after cleaning and disinfection according to the hospital s protocol ATTENTION After the test of a baby is finished the electrodes with gel protectors and the ear cush ion must be cleaned see chapter 9 If it is required to use new electrodes for every baby they can be disassembled just by pulling them out of the MB 11 BERAphone Put a new disinfected set of electrodes with gel protectors onto the MB 11 BERAphone just by pressing them gently into the three stainless steel pins The used electrodes with gel protectors must then be disinfected for new use It is rec ommended to have as many sets of electrodes with gel protectors available as needed for a day The disinfection can then take place during the night GEBA_8100496_MB11_BERAphone_e_3 18_14b 32 8100496 3 07 14 M Operating Instructions MB 11 MAICO 6 3 Performing the screening test M MB11 Anderson Carl Born 3 21 2012 Age 69 day s jol x File Settings About w MAICO MB11 Patient New Add to Today s List Display Today s List Show Measurements
34. 9 The averaging result in the time domain shows a clearly visible wave between 8 and 10ms with a broader part between 2 and 6ms ie Aey D gt Q z lt The ASSR detection algorithm operates in the frequency domain After transfor mation of the measured response into the frequency domain the periodical re Figure 49 sponse is represented by a relatively low Example of one period of a Auditory Steady State number of harmonics see Figure 70 response in the time domain stimulus repetition rate 93 Hz Amplitude and phase of all harmonics below 1200 Hz are considered by the test Statistic at a chirp repetition rate of 93 s 12 harmonics are included Between the harmonics a large number of spectral components at a resolution of 1 Hz approx 90 spectral components are located which contain no information about the response but only noise GEBA_8100496_MB11_BERAphone_e_3 18_14b 63 8100496 3 07 14 M Operating Instructions MB 11 MAICO In normal hearing newborns with a good 12 ASS response the amplitudes of the har 1o Fundamental frequency monics of the averaged response are sig nificantly higher than the noise compo nents If a hearing loss is present the harmonics would not be present signifi cantly higher than the noise components and so would just blend in with the noise floor a0 harmonics Spektrale Amplitude o gt a Frequenz Hz
35. ERAphone ear cushion around the baby s ear when the baby is tightly swaddled with the blanket obstructing the ear and neck area a Loosen the blanket so that you can achieve better access to the baby s ear b Swaddle the baby so that the shoulders are not pushed up tightly toward the neck and ears A baby who is tense in the neck and shoulder area will take longer to screen since muscle tension near the electrodes can cause artifacts slowing the test and increas ing the chance for a refer result Position the baby in a way that promotes neck and shoulder relaxation a This might be achieved by rolling the baby slightly on his her side with a rolled up blanket tucked along the back and into the curve of the neck b Grasping the baby s hand and gently guiding the arm down and toward the midline of his her body can promote relaxation of the shoulder and neck A tightly fisted hand is a sign that the baby is tensing the shoulder and neck mus cles c A baby is likely to initially react to the placement of the BERAphone by tensing up the shoulder and neck Typically however after a few seconds of continuing to hold the device in place following the baby s head movements the baby will begin to relax Beginning the collection can sometimes distract or relax the baby as they listen to the soft chirp sound If the baby is moving or tense start the screening so that the stimulus begins and then Pause the test until the baby qui
36. Last name First name Born Anderson Carl 3 21 2012 male Pat ID Screener 8457325252 Mary Smith O female R L L advanced MB 11 BERAphone s n 0000000 5 29 2012 4 Figure 24 MB 11 program start screen Enter or load patient data then select the ear to be tested by clicking on R for right and on L for left see figure 35 Next click on Measure The measurement screen opens see figure 36 nderson Carl Born 3 21 2012 Age 69 day s Ab MAICO EEG EEG ju p ow t e o 8 GE 0 5 10 15 25 30 35 40 20 Time ms Right Ear 70 Stimulus Level 35 dBnHL 0 10 20 30 40 50 60 80 30 Test Time s Notes Other Ear Start Measurement Pause MB 11 BERAphone s n 0000000 5 29 2012 4 Figure 25 Start measurement Prepare the baby and BERAphone as described in chapter 6 1 and place the BE RAphone as described in chapter 6 2 Start the test by clicking on Start Measurement button Before starting the measurement an automatic impedance test is performed GEBA_8100496_MB11_BERAphone_e_3 18_14b 33 8100496 3 07 14 Stimulus Level 35 dBnHL J Test Tune A Notes P Check impedance 72012 tirni CE Oep impedance of Verba ire 0 9 bObm mpedexe of Naitoti ine 0 9 ktm MB 11
37. Place the patient at least 1 5 m away from Note book or computer Alternatively work in battery mode use a Medical PC or a special mains adapter according IEC 601 1 GEBA_8100496_MB11_BERAphone_e_3 18_14b 4 8100496 3 07 14 M Operating Instructions MB 11 MAICO Precautions READ THE ENTIRE MANUAL BEFORE ATTEMPTING TO USE THIS UNIT Use this device only as described in this manual Before measurement make sure that the device works properly Do not drop or cause undue impact to this device If the instrument is dropped or dam aged return it to the manufacturer for repair and or calibration Do not use the instru ment if any damage is suspected Do not immerse the unit in any fluids See the Cleaning section of this manual for prop er cleaning procedures Use and store the instrument indoors only Do not expose this instrument or its acces sories to temperatures below 59 F 15 C or above 95 F 35 C or to relative humidity of more than 75 Do not attempt to open or service the instrument Return the instrument to the manu facturer for all service Opening the instrument case will void the warranty Disclaimer The MAICO MB 11 BERAphone Test Instrument is designed to be a screening device for hearing loss Sensitivity and specificity of this type of device are based on the test parameters defined by the user and may vary depending on environmental and operat ing conditions The presence of normal evoked pot
38. The ASSR is described in the frequency do main by a few spectral lines harmonics mathematically related to the stimulus rate of 93 Hz The statistical test uses the phase and amplitude information of the harmonics below 1200 Hz Frequencies in the processed EEG that are not related to the stimulus GEBA_8100496_MB11_BERAphone_e_3 18_14b 6 8100496 3 07 14 M Operating Instructions MB 11 MAICO rate contain no response to the auditory stimulus but only contain generalized EEG activity or noise These spectral lines will not be considered in the test result This sig nal detection algorithm is associated with short test times as well as high immunity against distortion from electrical interference The statistical test is performed using repeated EEG samples of one second The first test is done after passing the impedance test and then the test is repeated every sec ond until the overall test result arrives at critical value the green marked PASS criteria see figure 3 Then the test will be stopped with the test result PASS If the PASS cri terion is not achieved after 180 seconds of artifact free EEG sampling the test is termi nated with a REFER result Please see section 12 for additional scientific background on the stimulus and algorithm used with the MB 11 device Neither the algorithm nor critical test values are adjustable by the user Figure 3 MB 11 program test result PASS
39. Turn off monitor never Turn off hard disk never System standby never System hibernates never l Service_Manual doc Microsoft Word Edit View Insert Format Tools Table Window Help Adobe PDF Power Options Properties 2 x Power Schemes Alarms Power Meter Advanced Hibemate E Select the power scheme with the most appropriate settings for A this computer Note that changing the settings below will modify the selected scheme m Power schemes Portable Laptop z Save s Delete Settings for Portable Laptop power scheme When computer is E Running on Plugged in Never After 30 mins v Turn off hard disks Never After 30 mins Never Never Turn off monitor System standby Cancel Apply Figure 12 GEBA_8100496_MB11_BERAphone_e_3 18_14b 8100496 3 07 14 11 Running on batteries after 30min after 30min never never MAICO M Operating Instructions MB 11 Select Hibernate within the menu bar and change Hibernate settings to off as shown in the picture B11 5ervice_Manual doc Microsoft Word iPower Options Properties IES Power Schemes Alarms Power Meter Advance Hibernate When your computer hibernate it stores whatever it has in t memor on your hard disk and then shuts down When your computer comes out of hibernation it returns to its previous state Hibernate Disk space for h
40. al quality is good or not As long as the signal quality on the screen is red the signal quality indicator lights red too As soon as the signal quality is better and the test starts the signal quality indicator on the MB 11 BERAphone changes to green If the signal quality decreases for a certain time the signal quality indicator on the MB 11 BERAphone changes to red again and the test is paused Try to increase the signal quality again by moving the MB 11 BERAphone slightly to improve the impedance If the bad signal quality is caused by movements from the baby and muscle artifact the test will continue automatically as soon as the baby is calm and the signal quality is good again If necessary due to excessive agitation of the baby consider manually paus ing the data collection by pressing the PAUSE button and allow the baby to calm down before continuing the screening GEBA_8100496_MB11_BERAphone_e_3 18_14b 35 8100496 3 07 14 M Operating Instructions MB 11 MAICO 6 3 3 Advanced display mode EEG Display M MB11 Anderson Carl Born 3 21 2012 Age 69 day s i Ioj x File Settings About MAICO M Ec 20 Time ms NA Rig Stimulus Level 35 dBnHL 30 100 Test Time s 70 110 120 130 150 160 170 180 Notes Test in progress MB 11 BERAphone s n 0000000 Figure 39 Test screen in advanced display mode sjz9j2012 4 The advanced display mode c
41. an be entered by clicking on the box advanced on the left of the test screen The EEG view at the top of the screen allows you to monitor the ongoing real time EEG activity The EEG in this view will be relatively flat when the ba by and electrical conditions in the environment are quiet When the baby becomes ac tive you will note higher amplitude activity in the EEG representing myogenic activity from the baby If there is electrical interference in the room you may note spikes of ac tivity showing in the EEG This may be improved by checking the placement of the electrodes on the baby s head View of a rolling cyclical waveform in the EEG can indi cate that the electrode gel from two sites on the baby s head have merged This can negatively affect the quality of the recording GEBA_8100496_MB11_BERAphone_e_3 18_14b 36 8100496 3 07 14 Operating Instructions MB 11 6 3 4 The function buttons M MB11 Anderson Carl Born 3 21 2012 Age 69 day s Oj x File Settings About MAICO MB11 _ EEG Pass Criteria St pass PP Stimulus Level 35 dBnHL Notes el Pass MB 11 BERAphone s n 0000000 5 29 2012 4 Figure 28 MB 11 program Teststop At the bottom part of the test screen are the function buttons Other EAR After the test is finished you can change the ear to be tested Start Measurement Clicking on the Start Measurement button starts a
42. be saved HI TRACK A Tracking button will be added to the main screen Selection of this button opens a window providing access to a wide variety of fields that are compatible with the HI TRACK data man agement application The entered information and test findings are saved in a Tile that can be exported into the HI TRACK application see section 7 2 Figure 44 Menu setting Options OZ Systems As data is collected the patient and test information is saved automati cally in a Tile that can be exported into the OZ web based data management system Tracking File Name Here you can define the desired name for the tracking file Tracking Path Here you can define the path for the tracking directory GEBA_8100496_MB11_BERAphone_e_3 18_14b 41 8100496 3 07 14 M Operating Instructions MB 11 MAICO 7 2 Input of Tracking data If Settings HI TRACK is activated the function button Tracking appears on the start screen figure 45 MMB11 unnamed 10 x File Settings About Patient Add to Today s List Display Today s List Show Measurements Last name First name Born 5 29 2012 male Pat ID Screener Oo s O female Figure 45 Start screen with function button Tracking data Click on the Tracking button to open the in put window Figure 46 xl Pat ID 845 Patient data will be copied from the main screen Last nam
43. considered an aborted attempt If Tracking is enabled a pop up window with rea sons will appear requiring you to choose a reason for aborting the test l e Test abort ed because Technical Problems Invalid The reason will be stored in the database for quality controlled tracking 6 1 Preparing the baby for measurements Proper EEG measurements require a low skin electrode resistance electrode imped ance IMPORTANT If the baby s head has been lotioned oiled or treated with any greasy skin care products in the region where the elec trodes should contact then the lotion oil must be removed carefully prior to further preparation The choice of the remover Should be discussed with the nurse or doc tor Electrode gel must be applied softly on the skin in the areas for electrode contact so that the uppermost layer epidermis be comes highly conductive oe ity ane E T oei A Figure 31 Applying of electrode gel at the shown locations in direction of the arrows GEBA_8100496_MB11_BERAphone_e_3 18_14b 29 8100496 3 07 14 M Operating Instructions MB 11 MAICO The contact points are optimized for testing babies and determined by the spacing of the electrodes Figure 32 Application of electrode gel Step 1 Application of Step 2 Step 3 Application of electrode gel above the Application of electrode electrode gel below the ear contact of the ground gel on the vertex contact ear lobe c
44. creening Time Step Stimulus Standard ABR 70 dBnHL R E L advanced MB 11 Classic with EAR 34 s n 0000000 Figure 35 Program start screen with Time Step Stimulus 5 29 2012 4 After clicking on the button Time Step Stimulus the start screen shown in figure 55 is displayed You can select the maximum intensity of the time step stimulus test signal with the Level slider between 50 dBnHL and 70 dBnHL The default value is 60 dBnHL If the baby reacts sensitively to loud signals you should select 50 dBnHL After entering or loading the patient data select the ear to be tested Click on the MMB11 Miller Norma Born 5 9 2012 Age 20 day s lol x Eile Settings About MAICO Accepted 0 Artifact limit 20 uv Amplitude 0 5 uv k Time ms 10dBnHL 20dBnHL 30dBnHL 40dBnHL S0dBnHL 60dBnHL 24 28 Right Ear L advanced Stimulus Level 60 dBnHL Click Time Step Stimulus Other Ear Start Measurement MB 11 Classic with EAR 34 s n 0000000 Figure 36 MB 11 TSS Test Screen with Measurement 20 Time ms 5 29 2012 4 Measure button and the test screen as shown in figure 56 appears The EEG scaled in uV is displayed at the top of the screen If the EEG level is within the selected Artifact limit see box at the top left of the
45. e Notes Figure 47 Advanced tracking data vv The Advanced tracking dialog allows entry of Mother s data an Alternate Contact s information as well as documentation of the relevant risk factors for the baby 7 4 The export functions of the MB 11 database no tracking enabled The MB 11 software allows the export of patient and test data from the database The export Tile will be exported as text Tile txt in the Excel compatible CSV format The CSV format allows easy import into Excel or other software To export the data click Search on the start screen NNDS REEERE REER EeeE The Load from Database dialogue appears Fig 48 Choose the data for export using the filter fields and set the date range in the Date Export area Then click on the Export but ton below A browser dialog will open allowing you to type in the name of the export file and the location for storage You can limit the list of exported data using the various search filters described in section 5 5 1 Bi 9 27 9 1 5 4 9 25 9 27 201 9 29 201 9 25 10 3 9 5 201 10 2 201 1 1 2001 anans Figure 48 Load from Database GEBA_8100496_MB11_BERAphone_e_3 18_14b 43 8100496 3 07 14 M Operating Instructions MB 11 MAICO 7 5 The export functions of the MB 11 database Tracking enabled The MB 11 software allows the export of patient and test data from the database into
46. e First name Carl Date of birth Fill out the form with the information your Time of birth M 09 22 H Multiple birth code single birth Sex Mae program tracks Click on the advanced Race White E button to open the next input window which seau contains additional fields as seen in Figure 47 Sea iJ O O o Nou Nursery type Welbaby gt Physician Eve Adam Insurance code Unknown advanced Figure 46 Tracking data screen x Cancel GEBA_8100496_MB11_BERAphone_e_3 18_14b 42 8100496 3 07 14 M Operating Instructions MB 11 MAICO 7 3 Advanced Tracking data Advanced Tracking data l x Mother s data Risk indicator s Lastname Anderson Firstname am nET stigmata Maiden po Ee ies TER Weight lt 1500g Iv Hyperbilirubinemia I Phone 486 789 0123 Language English Bact meningitis E Congen infection City Town Areni Ototoxic medic Cranio facial anom I Mech ventilation Iv Head trauma I Zip code Address 2 Abnorm apgar sc Recu otitis media J State ID NICU IV Syndr w progr loss D E Date of birth E 5 29 1992 Alternate contact Care giver concern Neonatal ind I Last name ee Exp date ofbirth 5 29 2012 Phone Lanquage English Other City Town Relationship to mother Region unique ID Zip code Address 1 ist tracking variable State Address 2 2st tracking variabl
47. e MB 11 software is already installed If you use a computer that is NOT provided by MAICO please follow the instruction in chapter Installation and Settings or contact your local dealer 5 1 Unpacking your instrument Your MB 11 BERAphone was carefully inspected and packed for shipping However it is good practice to thoroughly inspect the outside of the shipping box for signs of dam age Carefully remove the instrument from the shipping box Remove the plastic bag from the instrument and inspect the case for any damage If any damage is noted please notify the carrier immediately This will assure that a proper claim is made Save all packing material so the claim adjuster can inspect it as well Notify your dealer or MAICO when the adjuster has completed the inspection SAVE ALL THE ORIGINAL PACKING MATERIAL AND THE SHIPPING CONTAINER SO THE INSTRUMENT CAN BE PROPERLY PACKED IF IT NEEDS TO BE RETURNED FOR SERVICE OR CALIBRATION All accessories are already packed in the compartment connected with the MB 11 BE RAphone Please check that all accessories listed below are received in good condition If any accessories are missing or damaged immediately notify your dealer or MAICO Standard Components 1 BERAphone complete with integrated preamplifier earohone and three stainless steel electrodes with gel protectors 1 Cradle for BERAphone 3 Additional stainless steel electrodes with gel protectors 1 USB connection cable
48. e phase delay describes how much a steady state cosine of a specific frequency is delayed from the input to the output of a system of the cochlea The group delay describes how much the envelope of a signal formed by a narrow group of frequencies is delayed through the system The results of a study confirmed the assumption that the latencies of the frequency specific ABR reflect the group delay Since the stimulus shall compensate for the coch lear delay of single frequencies the phase delay calculated from the group delay was used for the phase correction of the individual cosines of the stimulus Figure 68 shows the time course of the resulting CE Chirp Stimulus For preventing an overlapping of response harmonics by electrical artefacts the above described frequency offset has be added too CE Chirp 0 5 0 0 Rel Amplitude arb units Time ms Figure 48 Extensive investigations on newborns have shown that the CE Chirp Stimulus gener ates significant better results than other acoustical stimuli used for newborn hearing screening At 35 dBnHL stimulus level usually used for ABR based newborn hearing screening we found a high specificity and short test time in newborns The combina tion of the CE Chirp the ASSR algorithm and the BERAphone leads to very short ex amination times for newborn hearing screening GEBA_8100496_MB11_BERAphone_e_3 18_14b 62 8100496 3 07 14 M Operating Instructions MB 11
49. e_e_3 18_14b 46 8100496 3 07 14 M Operating Instructions MB 11 MAICO Therefore The latencies of the wave V s for an individual must always be in the same temporal relationship to the bars It is not possible for wave V at 50 dB for example to be at the end of the 50 dB bar but for 40 dB at the beginning of the 40 dB bar From the highest intensity onwards waves must be traceable without a gap through to the threshold The amplitude of the highest intensity can turn out to be slightly smaller but must still be recognisable It is not possible tor the 60 dB and 50 dB waves and also the 30 dB wave for example to be clearly recognizable but no response identifiable at 40 dB In this case the wave at 30 dB is determined to be artifact and not a reliable evoked potential If necessary repeat the measurement to clarify the situation A good indication for genuine ABR potentials is a peak one column width before the wave V This is the wave Ill but it is not always well formed GEBA_8100496_MB11_BERAphone_e_3 18_14b 47 8100496 3 07 14 M Operating Instructions MB 11 MAICO 8 1 2 Testing with the Time Step Stimulus MMB11 Miller Norma Born 5 9 2012 Age 20 day s lol xi File Settings About MAICO MB11 Patient New san Add to Today s List Display Today s List Show Measurements Last name First name Born Miller Norma 5 9 2012 O male Pat ID Screener Main 4fc4805F40f Mary Smith female S
50. ee chapter 5 7 or create a today s list of the patients to be tested today see chapter 5 8 Select the ear to be tested lt R gt for right or lt L gt left using the Ear button or the R L toggle control just above the Measure button GEBA_8100496_MB11_BERAphone_e_3 18_14b 26 8100496 3 07 14 M Operating Instructions MB 11 MAICO 5 7 Loading of stored patient data Load from Database Born 9 27 2011 9 1 2011 5 4 2011 9 25 2011 9 27 2011 9 29 2011 9 25 2011 10 3 2011 9 5 2011 10 2 2011 1 1 2008 anise soni uw gt First Name Abby Burns Carey Dirks earlyh ueueU Fred 10 Garvin Grow 11 Hanna 12345678 Mike odf dF odfedF 33 8533 4 53 5 3 3 ao Data Filters Data Export ascii Tracking Export Start export on 10 6 2011 Start export on 10 6 2011 v Last Name Range of Date 3j End export on End export on Test Result fal Results Droen E Oe Screener jal Screeners bd Export i i Export filtered Patients in Database dk a Number of patients 12 Cancel Figure 21 Load from database a l l Clicking on the Search button will display all stored patients see figure 28 Highlight a patient with the mouse and load the stored data by pressing the Enter but ton or double click the desired patient name with the mouse If a test result of this patient already exists the button Show Measure ments on the right of the scree
51. electrodes and gel protectors after cleaning Please make sure that the electrode with gel protection is plugged cor rectly and completely into the MB 11 BERAphone after cleaning In certain cases and only when considered necessary both the electrodes and the ear o_ Push the gel protector back on the electrode Plug the electrode with gel protection into the BERAphone Figure 44 cushions can easily be replaced with replacement parts as an alternative For more information see also Appendix B 9 2 Tips regarding use of the electrode gel It is important to avoid getting electrode gel into the inner parts of the MB 11 BE RAphone For this reason gel protectors are put on to the electrodes Only a small amount of gel placed on the electrode is typically required to perform a screening Avoid use of excessive amounts of gel that can seep down below the gel protector and into the critical components inside the electrode housing Never apply the electrode gel to the electrodes directly trom the gel bottle or tube It is not always possible to control the flow of gel from the bottle and you want to avoid accidentally squeezing a large quantity of gel on the electrodes or on the sensitive ear phone At frequent intervals the MB 11 BERAphone electrodes should be removed and cleaned thoroughly with a hospital grade disinfectant GEBA_8100496_MB11_BERAphone_e_3 18_14b 53 8100496 3 07 14 M Operating Instructions
52. enance Recommendations The MB 11 BERAphone is a considered a non critical patient care item since it comes into contact with intact skin but not mucous membranes For such devices guidelines from both the US Center for Disease Control CDC and the Robert Koch Institut Bun desinstitut f r Infektionskrankheiten und nicht Ubertragbare Krankheiten Berlin Ger many recommend cleaning and disinfection with a hospital grade surface disinfectant Important information The MAICO MB 11 BERAphone is intended for use on intact external skin around the ears and on the scalp It should not be used if the skin is not intact or if the baby has a contagious dermatological condition Recommendations for cleaning and disinfection of the BERAphone presented in this document are not intended to replace or contradict policies in effect or procedures required for infection control at the facility Definitions of terms Fixed elec megs por Electrode gel protector as _ Gel protector sembly gt black plastic m A Electrode tip stainless steel Electrodes X Spring loaded pin inside each fixed electrode post Ear Cushion Cleaning amp disinfection after screening each baby The BERAphone must be cleaned and disinfected after use on each baby 1 Clean off residual gel from the electrodes and ear cushion using a tissue or disin fectant wipe 2 Disinfect the electrodes ear cushion and other components tha
53. entials suggests normal hearing However a passing result using this instrument is not an indication that the full auditory system is normal Thus a passing result should not be allowed to override other indica tions that hearing is not normal A full audiologic evaluation should be administered if concerns about hearing sensitivity persist A REFER test result should not be assumed to be an indicator of a lack of auditory function however it should be followed with full audiologic diagnostic testing GEBA_8100496_MB11_BERAphone_e_3 18_14b 5 8100496 3 07 14 M Operating Instructions MB 11 MAICO 3 Description MB 11 tests hearing function by measuring the brainstem auditory evoked response of the auditory pathway Processing of EEG samples allows the auditory brainstem response generated by the delivery of the acoustic stimulus and present in the EEG to be differentiated from gen eralized EEG activity 3 1 Auditory Brainstem Response ABR audiometry Brainstem potentials BERA brainstem evoked response audiometry or ABR auditory brainstem response are optimally measured on a quiet sleeping patient In fact sleep is conducive to improving the quality of the recording and reducing test time 3 2 The BERAphone Traditional ABR screening of infants uses disposable elec trodes that adhere to the baby s skin for recording the response The patented BERAphone has spring mounted stainless steel electrodes a headph
54. ents Last name First name Born 5 29 2012 male Pat ID Screener rs O female a a MB 11 BERAphone s n 0000000 5 29 2012 4 Figure 32 MB 11 program start screen in advanced mode This offers the possibility of an immediate diagnostic evaluation of hearing after a screening result of REFER has occurred Using the BERAphone these tests are done under the same test conditions as the screening test For this purpose you can choose between Standard ABR with adjustable intensity or the Time Step Stimulus method which tests six intensities simultaneously Under good test conditions it is possible for an advanced tester to perform these meas urements with a calm or sleeping baby If you are not able to get good test results you should keep the baby calm by possibly feeding or sedating it You could also consider testing the baby another time when the baby is sleeping 8 1 Testing with the Time Step Stimulus 8 1 1 The Time Step Stimulus In the Standard ABR test the evoked potential is measured for individual clicks of a detined sound intensity Instead of individual clicks the step stimulus uses packets of GEBA_8100496_MB11_BERAphone_e_3 18_14b 45 8100496 3 07 14 M Operating Instructions MB 11 MAICO 6 clicks following each other very rapidly in which the intensity increases in 10 dB in crements for each click in the packet figures 53 and 54 As the entire
55. escription how to decrypt the tracking file and the password to enable or disable this option is only provided to an authorized person on demand The List Field Setup area allows you to add and delete names from the drop down fields Use the Add control to add new names to the drop down list Use the Delete control to remove the displayed name from the drop down field Examiner Screener a default name is present based on the PC name Names added to the Examiner Screener drop down list field will be accessible in the main screen The key combination of Ctrl E locks and unlocks the screener field on the main screen When locked then the screener field is ghosted with the default name displayed and cannot be changed When entering these names to be used with merging data to HiTrack they must be entered in exactly the same format as they are entered in the HiTrack application or there will be merge errors upon importing the tracking file into HiTrack Physician this is a HiTrack field The list of physicians is accessible tor selection when HiTrack is enabled and when the user enters the Tracking dialog by selecting the Tracking control on the main screen When entering these names to be used with merging data to HiTrack they must be entered in exactly the same format as they are entered in the HiTrack application or there will be merge errors upon importing the tracking Tile into HiTrack Screening location this
56. for repairs it is essential to send all the components as well Send the device to your dealer or to a service centre authorized by your dealer Please include a detailed description of faults In order to prevent damage in transit please use the original packing if possible when returning the instrument The customer is committed to dispose of the delivered goods according to the rules stipulated by law The costs for disposal have to be paid by the end user GEBA_8100496_MB11_BERAphone_e_3 18_14b 66 8100496 3 07 14 M Operating Instructions MB 11 MAICO 14 Safety Regulations 14 1 Electrical Safety The MB 11 BERAphone ABR Screener is specified to comply with the international standard IEC 601 1 EN 60601 1 The MAICO MB 11 is guaranteed according to IEC 601 1 safety against electrical hazard only when the connected notebook com puter is powered by batteries or the computers power supply ac cords to IEC 601 1 or IEC 950 1 safety regulations The instruments are not intended for operation in areas with an ex plosion hazard 14 2 Measuring security To guarantee that the instrument works properly it has to be checked at least once a year A The service and calibration must be performed by an authorized ser vice centre In accordance with the regulations of the EU medical di rective we will drop our liability if these checks are not done 14 3 Device control The user of the instrument should perform a
57. g an excessive amount of gel to the electrode and or the baby Re instruct the screeners to use only a small amount of gel on the electrode and to reduce the amount of gel used to prepare the baby s 4 Skin 8 If gel is observed inside the fixed electrode post use a dry cotton tipped applica tor to gently swab around the spring loaded pin to remove the gel GEBA_8100496_MB11_BERAphone_e_3 18_14b 74 8100496 3 07 14 M Operating Instructions MB 11 MAICO a Be careful not to bend the spring loaded pin so that it is no longer centered in the electrode post D A bent pin may cause the electrode to stick in the fully pushed in position If this happens you may have to manually release the electrode so it will soring out to make contact with the baby s skin C A bent pin can sometimes be manually pushed back into a centered position however a repair may be required if the electrode is constantly sticking in the pushed in position 9 When the disinfection product has thoroughly dried reconnect the removable electrodes to the fixed posts by aligning them with the spring loaded pin and pressing them Tully onto the pin Replacement of electrodes Replacement of the removable electrodes is recommended on a yearly basis It may be convenient to change the electrodes at the time of the device annual calibration More frequent replacement of electrodes may be required based on the cleaning and mainte nance
58. g the measurement press CTRL U and the pop up window opens To close the program just click on the QUIT lt Q gt button located on the bottom right of the screen Additional functions are located in the Menu bar at the top of the screen It contains the menus File Settings and About GEBA_8100496_MB11_BERAphone_e_3 18_14b 18 8100496 3 07 14 M Operating Instructions MB 11 MAICO 5 4 1 Menu File New Clears all patient information fields if they con MAMO ETTE tain information on a previously tested patient mies Settings About New Search Search Launches a dialogue that allows selection of a patient trom the integrated database In this window a patient can be selected by clicking the patient s name with Print the mouse Various means are provided to filter the pa Quit tient database so that fewer names appear in the list After clicking on the desired patient the patient s information Figure 24 appears in the fields of the start screen File Menu Data Filter options in the Search dialog include Last Name Filter Entry of a last name will filter the database to show only those with a matching last name Range of date filter Use of the drop down allows you to filter the database for baby s screened within a certain time period all data data from today data from last 3 days data from last 7 days data from last 30 days data from the past year
59. hat occurs immediately after an impedance test when cyclical noise is detected in the EEG signal The MB 11 Classic area allows the user to set preference related to testing when the hardware being used is the MB 11 Classic rather than the BERAphone This control will only show up in the dialog if an MB 11 Classic is attached to the PC when the software is launched Binaural test allowed Enabling this setting allows access to a binaural test option during data collection with the MB 11 Classic If this control is disabled then only the right ear or left ear can be selected and only a monaural test can be performed The Patient ID Settings area allows the user to set preferences regarding the handling of the patient ID Disable disables the field for the patient ID Control is not available when Tracking is enabled Disabling the Patient ID field allows you to collect and save test data with out entering a patient ID Disabling the patient ID can make it difficult to differentiate patients with the same name Automatic disables the Patient ID field for user entry but automatically assigns a random ID number upon entry of a new patient User entered the default setting requires user to enter an ID for each patient GEBA_8100496_MB11_BERAphone_e_3 18_14b 23 8100496 3 07 14 M Operating Instructions MB 11 MAICO 5 4 3 Menu About Click on About to see product informatio
60. he note above about using USB ports After a few seconds the system will show a message about a newly found USB device MAICO MB 11 Connect the USB drive delivered with the device and start the setup exe in the folder MB11 Software 4 3 Computer Settings for optimal performance To get the best possible power for the MB 11 BERAphone it might be necessary to change the properties of the used computer notebook systems A description of these settings Is provided below for Windows XP computers These installation instructions can be applied in a similar way for Windows 7 or Windows 8 For questions please contact your local dealer GEBA_8100496_MB11_BERAphone_e_3 18_14b 8 8100496 3 07 14 M Operating Instructions MB 11 MAICO 4 3 1 Deactivate save power USB hubs Therefore select Run within the START column type devmgmt msc and confirm Run x Type the name of a program folder document or Internet resource and Windows will open it for you Open devmgmt msc Cancel Browse Figure 5 Select Universal Serial Bus controllers and then tan Ta select a listed USB Root Hub Double click to open and take out the check mark if preselected Don t allow the computer to turn off this device to save power i0 x Fie Action View Help e mf888 zza SSS USB Root Hub Properties 2 xi Computer
61. ibemation Free disk space 3 603 MB Disk space required to hibermmate 504 ME cancel Ano _ Figure 13 Select Advanced within the menu bar and change Advanced settings to When close the lid of my portable computer Do nothing as shown in the picture IBER Aphone dit view Favorites Tools Help 2 xl Power Options Properties Hibernate jea Select the power saving settings you want to use Power Schemes Alarms Power blete Options T Always show icon on the taskbar Prompt for password when computer resumes from standby Power buttons Wher close the lid of my portable computer Do nothing z When press the power button on my computer Shut down When press the sleep button on my computer Shut down E coed n Figure 14 GEBA_8100496_MB11_BERAphone_e_3 18_14b 12 8100496 3 07 14 M Operating Instructions MB 11 MAICO 4 3 3 Change visual effects Optional at low power PC To change visual effects select Run within the START column type sysdm cpl and confirm Run e Type the name of a program folder document or Internet resource and Windows will open it For you Open sysdm cpl Cancel Browse Figure 15 System Properties 7 Performance Options 2 xi System Restore i Updates Ges ea vance Data Execution Prevention General Computer Name Hardware Select the settings you want to
62. ill help you achieve better and quicker screening results a In Mother s room or multi purpose rooms when other people are present ask others to suspend conversations or talk quietly and mute the TV radio during the screening b If a room or hallway adjacent to your screening room is noisy close the door to reduce the background noise c Try to avoid testing in a location near concentrated noise such as air conditioner vents 9 Some environments in the hospital are very noisy in terms of electrical interfer ence from other pieces of equipment nearby or even on adjacent floors of the hos pital If you are experiencing poor signal quality as seen by viewing the Signal Qual ity indicator in the software or on the BERAphone LED lights when the baby ap pears to be relaxed and free of muscle tension in the neck shoulder the source of the degraded signal quality may be electrical interference a Enable the advanced checkbox on the collection window so you can view the incoming electrical signal from the electrodes EEG b Do you see any rolling cyclical waves present in the EEG It so i Check to be sure that the electrode gel trom 2 electrode sites on the baby s head have not merged into one large gel area This salt bridge condition can produce this rolling electrical artifact poor signal quality and poor re cordings If you suspect this may be the case terminate or pause the test and clean the electrode gel
63. impedance test The impedance is the resistance between the measuring electrodes Vertex Mastoid and the ground electrode This impedance is influenced by the resistance of the elec trodes of the BERAphone and more important the resistance of the skin The imped ance should be in the range of 250 Ohm to 10 000 Ohm for each electrode pair Mas toid Ground and Vertex Ground Impedance in this range will allow the best EEG quality The impedance is improved by the application of the electrode gel Low elec trode impedance is optimal for the best quality recording The top of the test screen shows the impedance indicator lights figure 37 Here the tester can see easily the status of the impedance test for each of the three electrodes The green color symbolizes good impedance yellow means not optimal but sufficient to perform the screening Red signals indicate bad impedance and the test will not pro ceed The impedance values measured for Vertex Ground and Mastoid Ground lines are shown in the status line in the lower left corner at the screen In the case of a red light the impedance must be corrected This can be done by re peating the preparation with the electrode gel to lower the impedance of the skin In some cases it may take a few minutes for the electrode gel to soak into the skin and take effect The impedance can sometimes be improved by shifting the position of the electrode at that site slightly making sure t
64. ions MB 11 MAICO 5 6 Registry of new patient data Fie Settings About MAICO MB11 Patient ooo oah Add to Today s List Display Today s List Show Measurements Last name First name Born 5 29 2012 male Pat ID Screener ns Ce O femal Ear C advanced MB 11 BERAphone s n 0000000 s 29j2012 4 Figure 20 MB 11 program start screen with patient data For a fast screening test without tracking only a name birthday gender and Patient ID is required to run and save a test Tracking may require more detailed data Read more in Chapter 7 Tracking Enter the last name and first name of the patient baby with the keyboard Move be tween the different entry fields using the lt tab gt key or a mouse click in the required data field The current date is displayed as the default value for the date of birth The arrows on the right of the date field can be operated with the mouse to increase or de crease the value alternatively use the up and down cursor buttons of the keyboard or enter the date with the numeric keyboard Mark the sex of the patient by clicking the box male or female The lt Del gt key can be used to delete the default setting prior to entering a different value When Tracking System is activated it is possible to mark the patient as an outpatient Additionally you can load stored patient data s
65. is a HiTrack field The list of screening locations is accessible for selection when HiTrack is enabled and when the user enters the Tracking dialog by selecting the Tracking control on the main screen Birth Hospital this is a HiTrack field The list of hospitals is accessible for selection when HiTrack is enabled and when the user enters the Tracking dialog by selecting the Tracking control on the main screen It is referred to as the Hospital code in the Tracking window The Auto Track Settings area allows you to set your tracking preference No tracking no tracking file will be saved HiTrack during collection a Tile will be continuously saved and appended to with each screening test This file will be in the format required by the HiTrack third party database which the customer must purchase from the HiTrack provider This setting also impacts the Tracking export function that is accessed in the Search dialog So there are two ways to create a HiTrack tracking file One occurs automatically when the HiTrack tracking function is enabled One is performed through a manual process by exporting based on a manually entered date range entered in the Search dialog Track ing Export area OZ during collection a Tile will be continuously saved and appended to with each screening test This Tile will be in the format required by the OZ third party database GEBA_8100496_MB11_BERAphone_e_3 18_14b 22 8100496
66. n see figure 29 becomes active By clicking on this button you can scroll through these test results and load them Figure 22 MB 11 program with loaded patient data and active Show Measurement button GEBA_8100496_MB11_BERAphone_e_3 18_14b 27 8100496 3 07 14 M Operating Instructions MB 11 MAICO 5 8 Working with a Today s list If several tests will be conducted in one day it may be easier to enter the data of all M MB11 Anderson Carl Born 3 21 2012 Age 69 day s Oj x File Settings About MAICO MB1i1 Patient sah Add to Today s List Display Today s List Show Measurements Es Last name First name Born Anderson carl 3 21 2012 male Pat ID Screener 8457325252 Mary Smith female o M Csr a one MB 11 BERAphone s n 0000000 5 29 2012 4 Figure 30 MB 11 Today s list babies before you start to test In this case click on the button New and enter the name birthdate and sex as described in chapter 5 6 After the data is entered click on the button Add to Today s list Now click again on the button New and proceed as described before Repeat this until you have entered the data of all babies to be tested Later on when testing you just have to click the button Display Today s list The list of the babies to be tested today appears on the screen After selecting the
67. n about the software version and contact information GEBA_8100496_MB11_BERAphone_e_3 18_14b 24 8100496 3 07 14 M Operating Instructions MB 11 MAICO 5 5 Operation with mouse and keyboard or touch screen The MB 11 BERAphone program can be operated with the mouse by pointing and clicking on the required input field or button on the screen It is also possible to jump with the lt TAB gt key from field to field Pressing the Enter key activates the field or button If you use a touch screen you can run the program by touching the appropriate field on the screen Keyboard short cuts can also be used for fast operation Press the lt ALT gt key together with the underlined letter of the required button l e to start the measure press the keys lt ALT gt and lt M gt together Alt F File Alt S Settings Alt A About Alt N New Alt C Search Load from Database Alt T Add to Today s list Alt R Right Ear Alt L Left Ear AIt E Change Ear Alt D Display Today s list Alt M Start Measurement Alt S Stop Measurement Alt Q Quit Alt W Show Measurements Alt P Print Ctrl U USB Pop up window with the connected devices Ctrl B Beep at the end of the measurement Ctrl W Information about humming noise will disappear after 7 seconds Opens the Examiner Screener field on the Main screen for use of Ctrl E the drop down control GEBA_8100496_MB11_BERAphone_e_3 18_14b 25 8100496 3 07 14 M Operating Instruct
68. nd the amplitude of the first eight harmonics of the response to calculate the test value The statistical test is carried out in the following way The first test value will be calculated with a sample of the first 15 epochs If the test value is less than the critical test value the sample will be increased by one epoch and tested again This procedure will be continued until the test value is equal to or greater than the critical test value Then the testing is stopped with a Pass result If the critical test value is not reached after 180 epochs the test will stop with a refer result This successive procedure is more efficient than using a fixed large sample size and a single statistical testing However using such repeated testing one has to consid er that the error probability of the test increases with each test step leading to a de crease of sensitivity A so called Bonfferoni correction of the critical test value is known to compensate for this effect But the Bonfferoni correction leads to an overcorrection in the case of dependent samples Therefore a new method for the calculation of the critical test value for repeated testing of dependent samples had been developed The new procedure for the calculation of the critical test values for repeated testing of de pendent samples is described in detail in St rzebecher et al 2005 Automated auditory response detection statistical problems with repeated testing Int J Audiol 42 2 1
69. ndow The amplitude can be adjusted by clicking on the arrow right of the Amplitude box Values between 0 1 uV and 1 1 uV are selectable GEBA_8100496_MB11_BERAphone_e 3 18 14b 50 8100496 3 07 14 M Operating Instructions MB 11 MAICO 8 2 Testing with Standard ABR MMB1 1 Miller Norma Born 5 9 2012 Age 20 day s ioj x File Settings About MAICO MB11 Patient New Add to Today s List Display Today s List Show Measurements Last name First name Born Miller Norma 5 9 2012 O male Pat ID Screener Main 4fc4805f40f Mary Smith Screening Time Step Stimulus Standard ABR I 28 dBnHL Ue ONUA OOCOO R Ear L advanced MB 11 Classic with EAR 3A s n 0000000 5 29 2012 Figure 41 MB 11 program start screen in expert mode Standard ABR After clicking Standard ABR on the start screen an intensity level selector appears as shown in 45 The intensity level for the click can be adjusted between O and 70 dBnHL using the slider adjustment Next select the Ear to be tested by clicking R for right or L for left ear and then click Measure to begin the test The screen shown in figure 62 will appear In contrast to the time step stimulus the Standard ABR will only test at a single intensi ty When sufficiently high Stimulus levels are used all waves
70. ne_e_3 18_14b 39 8100496 3 07 14 M Operating Instructions MB 11 MAICO 6 3 7 Test result Abort M MB11 Anderson Carl Born 3 21 2012 Age 69 day s Oj x File Settings About MAICO MB11 E a O O O Abort Stimulus Level 35 dBnHL 0 10 20 30 40 50 60 70 80 90 100 110 120 130 140 150 160 170 180 Test Time s Notes Abort Other Ear Start Measurement Pause MB 11 BERAphone s n 0000000 5 29 2012 Figure 31 Test result Abort A test can be aborted by selecting the Stop Measurement button The test will be saved as an aborted test in the database If Tracking is enabled a pop up window with reasons appears After confirming a reason the result Abort with reason is shown in the green area see figure 43 GEBA_8100496_MB11_BERAphone_e_3 18_14b 40 8100496 3 07 14 M Operating Instructions MB 11 MAICO 7 Tracking The MB 11 software has an export function which allows export of patient and test da ta into files that are compatible with a few data management programs designed spe cifically to track newborn hearing screening information HI TRACK OZ or an ascii file 7 1 Tracking Settings Choose Settings Sub menu N MB11 unnamed Options Figure 44 See the area titled Auto Fie ESS About Tracking Settings in the dialog Tracking choices in this dialog are a Options No Tracking no tracking file will
71. o be in contact with area of the skin which was prepared with the electrode If these measures have been attempted and impedance remains poor then use of a more abrasive skin preparation product such as Nuprep or an electrode skin prep pad may be needed Poor impedance can occur if lotion has been applied to the baby s Skin The impedance test is passed when all three electrodes show green or yellow for seven seconds After passing the impedance test the measurement starts and the impedance indicator lights change into the signal quality light GEBA_8100496_MB11_BERAphone_e_3 18_14b 34 8100496 3 07 14 M Operating Instructions MB 11 MAICO 6 3 2 The signal quality control MB11 o signe Qua Stimulus Level 35 dBnHL Notes Test in progress Figure 27 MB 11 program test screen showing bad and good signal quality The signal quality in the screening mode is determined by the ratio of artifact and ac cepted signals Artifacts are big potentials caused by electrical noise muscle activity or muscle tension Signal quality depends strongly on the correct position of the electrodes and on electrical noise in the surrounding environment Also potentials from muscle activity disturb the measurements Excessive periods of artifact can prolong the test time and may increase the chance of a Refer result The signal quality indicator light on the MB 11 BERAphone also shows whether the sign
72. of the MB 11 BERAphone software eight harmonics were analyzed which means that seven of these eight har monics are overlapping with the stimulus frequencies This overlapping could lead to false results of the statistical test when electrical stimulus artefacts occur To eliminate this source of error a frequency offset Is introduced into the cosines This frequency off set causes a displacement of the stimulus frequency spectrum and prevents from any overlapping In the time domain the frequency offset leads to an alternating stimulus With this phase corrected stimulus a better detection time and shorter test time could be realized For further optimization the question of the adequate cochlea model for calculating the phase correction was addressed The cochlea model from de Boer is based on meas urements at ears of dead bodies with non physiological high stimulus levels Due to this fact the cochlea delay derived from the de Boer model has to be considered as not op timal For this reason a new model function of the trequency dependent propagation time in the cochlea was calculated based on the latency data of frequency specific ABR recorded at low stimulus levels GEBA_8100496_MB11_BERAphone_e_3 18_14b 61 8100496 3 07 14 M Operating Instructions MB 11 MAICO In this context the question arises as to whether the delay of the different models has to be considered to reflect the group delay or the phase delay of the cochlea Th
73. one to insure good contact with the prepared electrode sites It may take a few seconds to achieve opti mal impedance results If any electrode impedance continues to be red you may need to reapply gel to the skin and or to the electrode and try again If impedance remains poor after several attempts it may be necessary to use an elec trode skin preparation product such as NuPrep which is slightly abrasive to achieve good contact or to wash the area in case lotion was applied to the skin If washing is needed then reapply the gel to the site and to the electrode and try again Information In case of exceptionally small heads pre mature or NICU Babies it may be possible that the vertex electrode does not contact the vertex point For those special cases an extra long electrode Is available and can be ordered as an optional accessory Stainless steel electrode for pre mature infants IMPORTANT e The MB 11 BERAphone must never be applied with pressure You are support ing the BERAphone only to maintain the position of the electrodes and ear cush ion on the baby s head e The earphone with the black ear cushion must be positioned over the ear Make Sure there are no obvious gaps between the cushion and the baby s skin as this may reduce the intensity of the acoustic stimulus delivered to the baby s ear and increase the chance of a Refer test outcome e Never place the electrodes in the ear canal GEBA_8100496_MB1
74. one and preamplifier integrated in one unit see figures 1and 2 which is held to the infant s head after the three elec trode sites on the head have been rendered more con ductive by the application of electrode gel The only dis posable supplies needed for screening with the BE RApone are electrode gel and disinfectant wipes to clean and disinfect the instrument after each baby is tested Figure 1 Testing with BERAphone The BERAphone hardware is especially suited for in fants The vertex electrode is located in an adjustable mounting allowing the distance to the ground electrode to be varied to adjust for different head sizes Therefore the BERAphone can be used for ages from newborn up to older children depending on the size of their head The MB 11 BERAphone performs a fixed intensity 35 dB nHL ABR screening Figure 2 BERAphone with 3 3 Automatic Screening with Auditory Steady edad eoe and speaker State Algorithm The MB 11 uses a patented Auditory Steady State ABR algorithm This state of the art technology makes it possible to achieve faster test times than typical ABR screening de vices The acoustical CE Chirp stimulus is presented at a high repetition rate 93 second At this rate a so called Auditory Steady State Response ASSR occurs The objective Statistical determination of the presence of the ASSR is performed after the EEG Is pro cessed to determine its frequency content
75. ontact of the electrode of the mastoid electrode vertex electrode The mastoid electrode will be placed below the ear lobe Step 3 the ground electrode above the earlobe Step 1 and the vertex electrode in a straight line higher up in the direction of the forehead or vertex Step 2 Depending on the size of the head the posi tion of the vertex electrode can be adapted by rotating the black disc in which the elec trode is mounted in the BERAphone Put a small quantity approx 0 1 to 0 2 ml of gel on the tip of a finger and rub approx imately 10 to 15 times at the located areas direction of application as indicated in fig ure 31 It is advisable to start with the position above the earlobe then prepare for the vertex electrode and then finally apply electrode gel below the earlobe The baby should be in a relaxed and comfortable posi tion to minimize any potential muscular artifact and ensure optimum test outcome in the shortest time Make sure that the face neck and shoulder of the baby are relaxed and free of any obstructions Proper EEG measurements require a low skin electrode resistance electrode impedance Figure 23 IMPORTANT Avoid fluid bridges caused by electrode Application of electrode gel on the gel connections between the three gel sites on the PERAphone electrodes skin This can be achieved by always rubbing in the direction trom the face towards the back of the head see Tig 31 to ensure three di
76. owards the apex Figure 66 shows the delay of the travelling wave for reaching the various frequency bands in the cochlea calculated from the cochlea model of de Boer The Figure shows a Frequency Hz Time ms Figure 46 delay shorter than 2 ms for the region from 10 kHz to 1 kHz but a delay of 8 ms from the area of 1 kHz to 100 Hz Due to the resulting greater synchronization of excitation in the basal part of the cochlea only the higher frequency range contributes effectively to the click evoked activity The travelling wave delay in the more apical part of the cochlea is responsible for considerably dispersed responses from this area For this rea son the spatio temporally summated response does not achieve the amplitude that would result from a more synchronous excitation GEBA_8100496_MB11_BERAphone_e_3 18_14b 59 8100496 3 07 14 M Operating Instructions MB 11 MAICO The new CE Chirp Stimulus implemented in the MB 11 BERAphone allows a well syn chronized activation of the whole cochlea In contrast to the conventional generation of a click in the time domain in the frequen cy domain a click like stimulus can be created through the addition of a large number of cosines with a fixed frequency difference The frequency difference is selected in ac cordance with the desired stimulus repetition rate Figure 67 a shows in the right panel the frequency spectrum of such a click Every Amplitude o Spectral ampl
77. practices of the facility Replacement electrodes are available trom MAICO 1 Remove the electrode tip gel protector assemblies trom the fixed electrode posts by pulling each one straight out trom the fixed post 2 Discard the old electrodes 3 Connect a new set of electrodes to the posts by aligning them with the spring loaded pin and pressing them fully onto the pin Replacement of the ear cushion Replacement of the ear cushion is recommended on an annual basis It may be conven ient to change the ear cushion at the time of the device calibration More frequent re placement of the ear cushion will be required if the facility uses an alcohol based disin fectant product Replacement cushions are available from MAICO 1 Remove the ear cushion by pulling it off of the BERAphone 2 If there is any debris on the plastic mounting for the ear cushion clean and disin fect the area using a disinfectant wipe 3 Allow the disinfectant to dry thoroughly 4 Attach a new ear cushion to the BERAphone a A small notch at the top of the plastic mounting for the ear cushion can be used to start the connection of the ear cushion followed by a counter clockwise rotation of the ear cushion until it is fully attached to the plastic mounting D The ear cushion can also be attached by stretching it around the plastic mount ing until it is fully seated in place Annual calibration GEBA_8100496_MB11_BERAphone_e_3 18_14b 15 8100496 3 07
78. provide an appropri ated level of cleanliness Use of a non alcohol based disinfectant is recommended Non alcohol based products contain the active ingredient referred to as quaternary ammonia compound The qua ternary ammonia compound is specifically designed to disinfect rubber plastic silicone and acrylic products which are commonly used in hearing evaluation instruments Many common disinfectant wipes present in hospitals contain alcohol as a main disin fection ingredient However alcohol chemically denatures certain materials such as the material used in the BERAphone ear cushion With repeated exposure to alcohol based disinfectants the earohone material will harden crack and breakdown over time The higher the alcohol content of the disinfectant the faster the earphone will be af fected If alcohol disinfectant wipes are used to disinfect the BERAphone the earphone cush ion will need to be replaced more frequently than if a non alcohol based disinfection product Is used You can easily remove the stainless steel electrodes for cleaning purposes gt Ss O Remove electrodes carefully Remove gel protector from electrode Figure 43 GEBA_8100496_MB11_BERAphone_e_3 18_14b 52 8100496 3 07 14 M Operating Instructions MB 11 MAICO It is possible to sterilize the stainless steel electrodes not the gel protectors in an auto clave Alternatively you can perform a plasma sterilization of
79. r 8 Q Reusable stainless steel electrodes with gel protectors O to 70 dBnHL Factory preset at 35 GBnHL Factory adjustable only Integrated 87 dB Amplification 23 000x 8100496 3 07 14 M Operating Instructions MB 11 MAICO Quality control Integrated indicator red signal quality low green signal quali ty OK Weight 300 g Instrument MB 11 Box Power Supply via USB port of computer Power Consump max 400 mA tion Weight 165g Dimensions WxDxH 12x9x3cm Computer requirements com puter not included Type Intel Pentium 4 compatible or better RAM minimum 1GB Hard disk Minimal 5 GB free disk space Interface USB 1 1 or 2 Display SVGA Colour Display 800x600 or better Operating system Windows XP SP 3 Windows 7 32 64bit Professional or Ultimate Windows 8 Pro 32 64bit Mains supply Use only protective earth conductor plugs and wiring tor the power supply The lack of grounding will lead to enhanced humming noise with a large affect on the measure GEBA_8100496_MB11_BERAphone_e_3 18_14b 5 8100496 3 07 14 M Operating Instructions MB 11 MAICO ment quality The buzzing noise also affects the audio output of computers and pro duces a masking noise signal This will falsify the results of the measurements PC battery Mode To assure the most undisturbed humming noise free measurement and masking noise free stimuli it is necessary to disconnect all external accesso
80. r if appropriate Position the baby so he she is comfortable and in a way to release any tension in the neck A rolled up blanket tucked at the baby s side and in the curve of the next can help to release any tension in this area Check that the BERAphone has not slipped away from the prepared electrode sites and the electrodes are in contact with the skin If so shift it back into place GEBA_8100496_MB11_BERAphone_e_3 18_14b 55 8100496 3 07 14 M MAICO Operating Instructions MB 11 11 Technical Data The MB 11 BERAphone is an active diagnostic medical product according to the class Ila of the EU medical directive 93 42 EEC 0123 Standards Approvals Test signals Stimulus rate EEG filter Sample rate Quality control Environmental condi tions Probe BERAphone Speaker Electrodes Level range Preamplifier GEBA_8100496_MB11_BERAphone_e_3 18_14b 56 IEC 601 1 IEC 645 3 IEC 645 7 Type 2 US F D A 510 k 082035 Screening CE Chirp Stimulus Time Step Stimulus Opt Chained Click ABR Opt Click Screening 93 s Time Step Stimulus 20 s Standard ABR 14 s 125 Hz 1 25 KHZ 16 kHz Integrated indicator in BERAphone and display in software with signal quality display or with EEG 15 4 35 59 95 F operation 5 4 50C 41 122 F storage Maximum humidity 75 operation Maximum humidity 90 storage Integrated dynamic wideband speake
81. racking 7 1 Tracking Settings 7 2 Input of Tracking data 7 3 Advanced Tracking data 7 4 The export functions of the MB 11 database no tracking enabled 7 5 The export functions of the MB 11 database Tracking enabled 8 Follow up measurements GEBA_8100496_MB11_BERAphone_e_3 18_14b 1 M Operating Instructions MB 11 0 Q Co D O oNNUuU UW BWWOWOWWMOMA WANN A W NNN U1 A NNN oo N O N O A UW Ww Ww W WW W WN O WO O NAU A Ww O 2 BRAAASHA e UW UW N IN UI 8100496 3 07 14 MAICO 8 1 Testing with the Time Step Stimulus 8 1 1 The Time Step Stimulus 8 1 2 Testing with the Time Step Stimulus 8 1 3 Advanced display Time Step Stimulus Test 8 2 Testing with Standard ABR 9 Care and maintenance of the instrument 9 1 Cleaning the MB 11 BERAphone 9 2 Tips regarding use of the electrode gel 10 Trouble shooting 11 Technical Data 12 Scientific Background Information 12 1 CE Chirp Stimulus 12 2 Sensitivity and specificity of the Auditory Steady State algorithm 13 Warranty Maintenance and After Sales Service 14 Safety Regulations 14 1 Electrical Safety 14 2 Measuring security 14 3 Device control 14 4 User Instruction 14 5 Patient safety 15 Recommended literature APPENDIX A APPENDIX B GEBA_8100496_MB11_BERAphone_e_3 18_14b 2 M Operating Instructions MB 11 45 45 48 50 51 51 52 53 54 50 59 59 63 66 6 6 6 6 6 6 69 70 73 81
82. roup 1997 Hamill T A Hussung R A and Sammeth C A Ear and Hearing 12 4 229 234 Sturzebecher E Cebulla M and Elberling C Int J Audiol 42 2 110 7 2005 Cebulla M StUrzebecher E and Elberling C J Am Acad Audiol 17 93 103 2006 Sturzebecher E Cebulla M Elberling C and Berger T J Am Acad Au diol 17 448 461 2006 Cebulla M StUrzebecher E and Elberling C J Am Acad Audiol to be pub lished soon 69 8100496 3 07 14 M Operating Instructions MB 11 MAICO APPENDIX A Tips for Screening with the MB11 BERAphone 1 A baby who is quiet comfortable and preferably sleeping is in the ideal state for screening While screening can be successful on a baby who is awake sucking in termittently on a pacifier or nursing the test time will be longer and the chance of a refer result will be higher However if the pacifier or nursing ultimately calms an agitated baby by all means try anything you can think of to calm a fussy baby Screening within a few hours after birth can be successful because the baby is often sleeping very soundly at this time However vernix blocking the ear canal can cause a refer result when screening is performed early Try to clear the canal by grasping the ear gently pulling and rotating the ear Massage the area just in front of the ear canal opening These maneuvers can help to open up the ear canal improving the chance for a Pass result It will be difficult to place the B
83. s to move upward on the graph until the green area is reached Then 100 of the pass criteria is fulfilled and the test was passed successfully The result PASS is shown in the green area see fig ure 41 However a PASS result using this instrument is not an indication that the full audito ry system is normal Thus a passing result should not be allowed to override other indi cations that hearing is not normal A full audiologic evaluation should be administered if concerns about normal hearing persist GEBA_8100496_MB11_BERAphone_e_3 18_14b 38 8100496 3 07 14 M Operating Instructions MB 11 MAICO 6 3 6 Test result Refer MMB11 Anderson Carl Born 3 21 2012 Age 69 day s 7 iol x File Settings About MAICO MB11 L EEG Stimulus Level 35 dBnHL 0 10 20 30 40 50 60 70 80 100 110 120 130 140 150 160 170 180 90 Test Time s Notes Refer Other Ear Start Measurement Pause MB 11 BERAphone s n 0000000 5 29 2012 4 Figure 30 MB 11 program Test result REFER If the pass criterion is not reached after 180 seconds of test time the result Refer displays in the lower right corner Figure 42 If you cannot exclude poor test conditions as a reason for the Refer you should con sider performing a retest when the conditions have improved Follow your program s protocol for handling patients with a Refer outcome GEBA_8100496_MB11_BERApho
84. stinct gel areas that do not contact each GEBA_8100496_MB11_BERAphone_e_3 18_14b 30 8100496 3 07 14 M Operating Instructions MB 11 MAICO other Particularly critical is the distance between the electrode above the ear ground electrode and the vertex electrode Ensure that a finger wide area remains free of elec trode gel Finally apply a small drop of electrode gel on each electrode of the BERAphone see fig 33 6 2 Placement of the BERAphone Once the measurement program has been started place the BERAphone on the ba by s head figure 34 First try to position only the mastoid electrode below the earlobe The other two electrodes are initially left without contact Once this electrode has been positioned fol low any movements of the head with the BE RAphone without losing the position of the mastoid electrode The other two electrodes still do not have contact with the skin Once the baby is calm the BERAphone is lowered to the vertex paying attention to a good contact of the electrodes The correct position of the BERAphone is checked with the Impedance Test see chapter 6 3 1 After passing the impedance test the measurement Figure 34 starts and the impedance display changes into Placement of the BERAphone the signal quality display If the impedance remains poor shown by a red background color at one or more of the electrode indicators on the screen slightly reposition the BERAph
85. subjective instrument check once a week For your own security you should copy the printout of the test and store it in your files 14 4 User Instruction The MAICO MB 11 BERAphone is de signed to be used only by skilled personnel Audiologists physicians or other trained personnel No person should attempt to use this in strument without the necessary knowledge and training to under stand how this equipment is to be properly utilized and interpreted 14 5 Patient safety Warning Do not take a test while charging the device via USB cable External equipment intended for connection to signal in put signal output or other connector shall comply with relevant IEC standard e g IEC 60950 for IT equipment and the IEC 60601 series for medical electrical equipment In addition all such combinations systems shall comply with the standard 60601 1 1 Safety requirements for medical electrical systems Equipment not complying with IEC 60601 shall be kept outside patient environment as defined in the standard at least 1 5 m from the patient Any person who connects external equipment to signal in put signal output or other connectors has created a sys tem and is therefore responsible for the system complying with the requirements of IEC 60601 1 1 If in doubt con tact your service technician or local representative for help GEBA_8100496_MB11_BERAphone_e_3 18_14b 6 8100496 3 07 14 MAICO M Operating Instructions MB 1
86. t intact or if the baby has a contagious dermatological condition Electro medical instruments with strong electromagnetic fields e g microwaves radio therapy devices can influence the function of the MB 11 BERAphone Therefore the use of these instruments is not allowed in close proximity to the MB 11 BERAphone The test room must be at normal temperature usually 15 C 59 F to 35 C 95 F If the device has been cooled down e g during transport please wait until it has warmed up to room temperature The MAICO MB 11 BERAphone is specified according to IEC 601 1 safe ty against electrical hazard This is only guaranteed when the connected notebook computer is powered by batteries or the computers power sup ply accords to IEC 601 1 or IEC 950 1 safety regulations and an isolation transformer meeting requirements of IEC 61558 2 1 or 60601 1 is used The complete system must meet the leakage current requirements of IEC 60601 1 1 This complete system consisting of the MB11 BRAphone computer and isolation transtormer is suitable for use in the patient envi ronment Equipment not complying with IEC 60601 shall be kept outside the patient environment Additional equipment not specified as part of the system shall not be connected Prevent cable breakage The MB 11 BERAphone cable must not be bend or buckled Do not use the instrument if the mains cable and or the outlet Is damaged gt p gt D Patient safety
87. t made contact with the baby or the baby s bedding by wiping them with a fresh hospital grade disin fectant wipe designed for use on hard surfaces a Use of a non alcohol based disinfectant product is recommended in order to pre serve the material of the ear cushion Non alcohol based disinfectants contain the ac tive ingredient referred to as quaternary ammonia compound GEBA_8100496_MB11_BERAphone_e_3 18_14b 73 8100496 3 07 14 M Operating Instructions MB 11 MAICO D If an alcohol based disinfectant is used repeatedly on the ear cushion the mate rial will be chemically denatured over time causing it to harden and crack It will need to be replaced on a more frequent basis The higher the alcohol content of the disin fectant product the faster the ear cushion will be denatured requiring replacement Replacement ear cushions are available from MAICO or your local distributor C Follow the directions for use and precautions on the disinfectant product d If the disinfectant wipe is very wet do not allow disinfectant to drip down into the black perforated speaker inside the BERAphone ear cushion area 3 Disinfect any other components that touched the baby or the baby s bedding such as the cable BERAphone handle etc 4 Allow the disinfectant to dry thoroughly on the BERAphone before using it on the next patient Routine periodic inspection inside electrode gel protectors and stationery electrode post
88. this is selected the averaged data will be dis played at the bottom and the data stored within the separate A and B Buffers will be displayed at the top The Filter function allows you to smooth the Che tirg bat MAICO Artifact limit ow z Amplitude r e R 5 ospy Time fs m t 3 N Figure 38 Test screen advanced 3 r Parma Dorme 5 0 2017 Ape 2D daya JE XJ 2e tinge Abas MAICO Accepted 2400 Artifacts 28 ifact linet pV EERS 0 5 pV Tim hme Ba AUG tei I HAA teu At Hit i itty ty Nyy Ht OY vy E Fit E ION Dr IL ALAA rn Gt INL IAL IAEA a a fa adhamcod y 7 i Thee fre i Stimulus Level 60 dBnHL Cick Time Step Stimulis lt Figure 39 Test screen advanced A B curves on the screen The cut off frequencies of the filter are 163 Hz and 1930 Hz The boxes for the adjustment of the artifact limit and the amplitude of the AEP display are located on the upper left part of the screen The actual value of the artifact limit is shown under Artifact limit For example in figure 60 the actual artifact limit is 20 uV The artifact limit can be adjusted by clicking on the arrow right of the Artifact limit box Values between 5 uV and 50 pV are selectable The display magni tude of the AEP s waves is shown under Amplitude in figure 60 the actual amplitude Is 1 0 uV Artifact limit 20 uY Amplitude 1 0uV fy For example Figure 40 EEG Quality wi
89. ts for printing to the label print er Enable Selected Data Printout to choose from a list of results for the current patient and print these results These results can be printed to either a standard printer or to a label printer When using a standard printer the results will print in lines on one print out When printing to a label printer each selected test will print out on an individual label Enable Screenshot Printout if you wish to print the graphical display of the final result for a chosen screening test This is the same view of the measurement screen that you see at the conclusion of a screening It does not print an ABR waveform Printer Settings This control opens a standard Windows printer dialog from within the MB 11 software For efficiency it is recommended that you set the typical printer you will use to print your MB11 results as the default printer in the operating system settings GEBA_8100496_MB11_BERAphone_e_3 18_14b 21 8100496 3 07 14 M Operating Instructions MB 11 MAICO Encode Export Data If this option is enabled all tracking files will be encrypted dur ing export In order to make sure that exported data cannot be read or manipulated by any unauthorized person A password is required to enable or disable this option The exported text file can be decrypted by a separate decoder tool Usually this is done at the tracking centre where the exported Tile is send to A d
90. tude dB Amplitude Spectral amplitude dB Amplitude Spectral ampltude dB i du n Figure 47 component of the spectrum represents a cosine The difference between the single co sines is 93 Hz and is equal to the stimulation rate of 93 s A ripple between the individ ual pulses of the stimulus in the time domain can be effectively reduced by halving the amplitudes of the cosines with the lowest and the highest frequency figure 67 a In contrast to the standard click generated in the time domain the new stimulus is a steady state signal The patented stimulus constructed from individual cosines offers the possibility of intro ducing a frequency dependent phase correction in order to compensate for the propa gation time in the cochlea From this phase correction a synchronized activation of the whole basilar membrane can be expected Figure 67 b shows at the left the time course of a phase corrected click The corre sponding amplitude spectrum is shown at the right side The red arrows mark as an GEBA_8100496_MB11_BERAphone_e_3 18_14b 60 8100496 3 07 14 M Operating Instructions MB 11 MAICO example the position of the first six spectral harmonics of the brainstem response evoked by the phase corrected stimulus It is easy to see that five of the six harmonics of the brainstem responses are overlapping with the stimulus frequencies By the objective statistical test implemented in the automatic test algorithm

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