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Operating Instructions MB 11 Classic

1. User Profiles Desktop settings related to your logon Settings Startup and Recovery System startup system failure and debugging information Settings Environment Yarnables Error Reporting cet __ Figure 16 GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 17 8100802 5 06 14 i Operating Instructions MB 11 MAICO Performance Options ajx E ee avancen Data Execution Prevention Select the settings you want to use For the appearance and performance of Windows on this computer Let Windows choose what s best for my computer Adjust for best appearance djust For best performance Custom J Animate windows when minimizing and maximizing LJ Fade or slide menus into view J Fade or slide ToolTips into view J Fade out menu items after clicking J show shadows under menus show shadows under mouse pointer Show translucent selection rectangle C Show window contents while dragging J Slide open combo boxes J Slide taskbar buttons 1 Smooth edges of screen Fonts Figure 17 GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 18 8100802 5 06 14 i Operating Instructions MB 11 MAICO 4 4 4 Change Display Properties Optional at low power PC To change display properties select Run within the START column type desk cpl and confirm Select Desktop and change background settings to none Select Screen Saver setting to none Type the name of a
2. MAICO Diagnostic GmbH MAICO Operating Instructions MB 11 Classic 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 MB 11 Classic 3 3 Automatic Screening with the ASSR Algorithm 4 Installation and Settings 4 1 USB Specifications 4 2 Installation of MB 11 Software 4 3 Minimum computer specifications 4 3 1 Power supply 4 4 Operating system settings 4 4 1 Deactivate save power USB hubs 4 4 2 Change Power Options 4 4 3 Change visual effects 4 4 4 Change Display Properties 4 4 5 BIOS Setup 5 Getting started 5 1 Unpacking your instrument 5 2 Preparing the MB 11 for use 5 3 Device Recognition 5 4 Menus 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 stored patient data 5 8 Working with a Today s list 6 Automatic testing in the automatic ABR screening mode 6 1 Preparing the Patient for measurements 6 2 Placement of the Electrodes 6 3 Placement of EarCups 6 3 1 Insert earohone tubing and adapters 6 3 2 Use of adhesive EarCup couplers 6 3 4 Removal of disposables 6 4 Performing the screening test 4 1 Impedance Test 4 2 The signal quality control 4 3 EEG Display 6 4 4 Test result P
3. The lack of grounding will lead to enhanced humming noise with a large affect on the measurement quality The buzzing noise also affects the audio output of computers and produces a masking noise signal This will falsity the results of the measurements PC battery Mode To assure the most undisturbed humming noise tree measurement and masking noise free stimuli it is necessary to disconnect all external accessory 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 GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 54 8100802 5 06 14 M Operating Instructions MB 11 MAICO 9 Scientific Background Information 9 1 CE Chirp Stimulus The stimulus for an automated ABR 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 traveling wave runs from the basal part of the cochlea along
4. Figure 36 MB 11 program Test stop Other Ear After the test is completed on one ear use this button to change to the other ear Then select Start Measurement when ready Note that when an MB 11 Classic is attached to the PC the Other ear button cycles through selections for Right ear Left ear and Binaural i e Both ears tests if the Binaural testing setting is enabled in the Options dialog Be sure that you cycle through to your desired ear measurement based on the ear s to which you have coupled the insert phones Start Measurement Click on the Start Measurement button to begin a 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 result Abort will be displayed and stored in the database for quality controlled tracking If tracking is enabled then a pop up window will open allowing you to choose the reason for the test termination Pause Stops the collection and processing of EEG samples although the acoustic stimulus continues to be presented The function button changes to Continue and the status indication at the bottom of the screen shows Test in progress Select the Continue button to resume data processing Quit Completes the screening phase and returns to the main screen GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 42 8100802 5 06 14 A Operating Instruc
5. 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 GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 26 8100802 5 06 14 i Operating Instructions MB 11 MAICO 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 Physician this is a Hilrack field The list of physicians 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 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 is a Hilrack 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
6. After cleaning the residue of this cleaning product should be wiped away so that the skin is dry to promote optimal adhesion of the electrode to the skin Electrodes will be placed on three locations on the patient s head i e the center of the forehead at the hairline the side of the forehead near the temple or alternatively on the cheek and the nape of the neck The adhesive EarCups around the ear couplers need to be used with the insert earphones to deliver the acoustic stimulus The patient should be made as comfortable and relaxed as possible to minimize any potential muscle artifacts and ensure optimum test outcome in the shortest time Make sure that the face neck and shoulder of the patient are relaxed GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 34 8100802 5 06 14 M Operating Instructions MB 11 MAICO 6 2 Placement of the Electrodes For electrode placement the skin should be cleaned with an electrode skin preparation product to remove any oil and dirt from the skin s surface Using a cotton tipped applicator or your finger rub the skin briskly but gently several times with the product This will help to reduce skin impedance and ensure proper recording conditions After skin preparation use a tissue to wipe away any residue of the skin prep product and to dry the skin Then with the electrode cables already snapped clipped onto the disposable electrodes apply an adhesive electrode on each of the thre
7. Drusy BB Born 10 11 2011 Age 17 day s File Settings About MAICO EEG EEG uv 20 Time rns Passcriteria Stimulus Level 35 dBnHL 80 30 100 Test Time s Notes Pass Other Ear Start Measurement MB 11 Classic with EAR 34 s n 0047594 10 28 2011 Figure 40 MB 11 Binaural screening program Test result PASS GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 46 8100802 5 06 14 MAICO M Operating Instructions MB 11 If no response is detected in one or both ears the line for that ear will not reach the 100 green area after 180 seconds the result will be REFER NOTE For Binaural Testing a PASS result can only be obtained when the 100 pass criteria are reached by both ears If either of the ears fails to reach the 100 pass criteria after three minutes even if the other ear had reached the 100 pass criteria the screening result will be shown and recorded in the database as REFER for proper follow up actions Figure File Settings About MAICO EEG 10 se 25 a g W 5 a 20 40 Time fms Passcriteria lt 7 bed API Stimulus Level 35 dBnHL 0 10 20 30 40 50 80 30 1 140 Test Time s Notes Refer Other Ear Start Measurement Quit MB 11 Classic with EAR 34 s n 0047594 10 28 2011 Figure 41 MB 11 Binaural screening program Test result REFER GEBA_8100802 5_MB_11_Classic_EarCups_ 3 18 e 14b 47 8100802 5 06 14 i Operating Instructions MB
8. MB 11 MAICO 5 6 Registry of new patient data File Settings About MAICO oe Patient Last name First name M d yyyy Pat ID Screener Ear L 11 Classic with EAR 34 s n 0047594 10 27 2011 Figure 27 MB 11 program start screen with patient data For a fast screening test without tracking it is sufficient to enter the last and first name birthday gender and Patient ID If you do not enter this information but continue with collection anyway the patient and tests performed will not be saved in the database Tracking may require more detailed data Read more in Chapter 7 Tracking Enter the surname and first name of the patient baby with the keyboard Move between the different entry fields using the lt tab gt key or a mouse click in the required data field The current PC date is displayed as the default value for the date of birth Use the calendar control to modify the birthdate Mark the sex of the patient by clicking the male or female radio button The lt Del gt key can be used to delete the default setting prior to entering a different value Additionally you can load stored patient data see 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 buttons located just above the Measure button Now you are ready for testing The test procedure
9. 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 trom within the MB 11 software For efficiency it is recommended that you set the typical printer you will use to print your MB 11 results as the default printer in the operating system settings Encode Export Data If this option is enabled all tracking Tiles will be encrypted during export In order to make sure that exported data can t be read or manipulated by any unauthorized person A password is required to enable or disable this option The exported text Tile can be decrypted by a separate decoder tool Usually this is done at the tracking centre where the exported file is send to A description 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 trom the drop down field Examiner Screener
10. is described in chapter 6 GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 31 8100802 5 06 14 A Operating Instructions MB 11 MAICO 5 7 Loading stored patient data Load from Database uw Q xx First Name Abby Burns Carey Dirks earlyh ueue Fred Garvin Grow Hanna 12345678 Mike adfadf odfedF 23 3 Sea S08 S Sta Data Filters a Data Export ascii al Tracking Export Start export on Start export on 10 6 2011 10 6 2011 Last Name A n End export on End export on Test Result All Results 10 6 2011 10 6 2011 i filtered Patients in Database Number of patients 12 i Figure 28 Load from database After clicking on the button Search all stored patients will be shown see Figure 28 Select a patient by double clicking on the name with the mouse or highlight the desired name and select the OK button If a test result already exists for Fe Sargs ibat this patient the button Show Measurements on the right if lt ali the screen see Figure 30 a ram m O becomes active By clicking on this button you can view a list of all tests performed on this patient and review each test result Figure 29 MB 11 program with loaded patient data and active Show Measurement button GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 32 8100802 5 06 14 i Operating Instructions MB 11 MAICO 5 8 Working with a Today s list
11. screen of the MB 11 program GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 23 8100802 5 06 14 M Operating Instructions MB 11 MAICO 5 4 Menus 5 4 1 Menu File New Entry of a new patient see also Tracking Patient data Clears all fields if they contain gy Settings About information on a previously tested patient New Search Search Launches a dialogue that allows selection of a patient from the integrated database In this window a patient can be _ Wut selected by clicking the patient s name with the Faure 24 mouse Various means are provided to filter the fle Menu patient database so that fewer names appear in the list After clicking on the desired patient the patient s information appears in the fields of the start screen Print 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 trom today data trom last 3 days data from last 7 days data from last 30 days data trom the past year 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 Meas
12. 11 MAICO 7 Tracking The MB 11 software has an export function which allows export of patient and test data into files that are compatible with a few data management programs designed specifically to track newborn hearing screening information HI TRACK OZ ESP or an ascii file 7 1 Tracking Settings M MB11 unnamed Choose Settings Sub menu File ESS About Options Figure 42 i The Options dialog opens and the tracking Options controls are Figure 42 No Tracking no tracking file will be Menu setting Options access to Tracking 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 management 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 OZ Systems As data is collected the patient and test information is saved automatically in a Tile that can be exported into the OZ web based data management system Note binaural tests collected with the MB 11 Classic hardware are not compatible with the OZ tracking system at this time If you use OZ as your tracking database perform only monaural tests with your MB 11 Tracking File Name To define the desired name for the tracking file Tracking Path Here you can define the path for the track
13. 2 8100802 5 06 14 i Operating Instructions MB 11 MAICO 5 3 Device Recognition You can connect multiple MB 11 devices to a single computer When more than one MB 11 device is attached to the PC a pop up window displays the connected instruments when the software is launched At that time you can choose the device you want to use with a mouse click The most common scenario in which you would experience this pop up window is if you have purchased a combination system including both the MB 11 BERAphone and the MB 11 Classic hardware To change between the BERAphone and the Classic hardware between screenings after the software has been launched press CTRL U and the pop up window opens allowing you to select your alternate hardware 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 After starting the computer launch the MB 11 software by clicking the shortcut icon MB 11 USB Version on the desktop or direct from the program menu The program launches with the start screen see Figure 23 Fie Settings About MAICO MB 11 Patient Search Add to Today s List Bom Last name First name M d yyyy 10 5 2011 7T O male Pat ID Screener USER mis_ksm o Ts O female Figure 23 Start
14. 33 8100802 5 06 14 i Operating Instructions MB 11 MAICO 6 Automatic testing in the automatic ABR screening mode It is fast and easy to screen patients with the built in patented automatic Fast Steady State Algorithm At the conclusion of the test or when the test is Manually terminated one of the following results will display and be saved with the screening Test Result Definitions PASS As soon as the indication mark reaches the green area has met the Pass criteria the result is PASS For binaural measurements a PASS is only displayed if both ears passed the test REFER If no response at the test level of 35 dB nHL is present after 180 seconds of data collection the test is automatically terminated with a REFER result In this case follow your screening program protocol to determine whether another screening should be performed or whether the baby will be referred for a diagnostic follow up test ABORT If the test is aborted Stoo Measurement is pressed during the test the test is labeled as ABORT If any tracking is enabled then a pop up window appears for selection of a reason for stopping the test 6 1 Preparing the Patient for measurements Optimal ABR recording requires low skin electrode resistance electrode impedance To achieve low electrode impedance the skin in the location where the disposable electrodes will be applied must be cleaned with an electrode skin preparation product
15. 8100802 5 06 14 i Operating Instructions MB 11 MAICO USB Root Hub Properties x General Power Driver Details Power Management fe r USB Aoot Hub low the computer to turn off this device to save power a this device to bring the computer out of standby Deactivate both Cancel Figure 7 If there are more than one listed USB Root Hubs please repeat the procedure as described above and take out the check mark if preselected for each of them Do not allow the computer to turn off this device to save power GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 12 8100802 5 06 14 iY Operating Instructions MB 11 MAICO 4 4 2 Change Power Options To change power options select Run within the START column type powercfg cpl and confirm I VaReOT DUCE Neues Office Dokument a _Office Dokument ffnen ES Windows Catalog Databook windows Update Set Program Access and Defaults SS WinRAR exe Programs 4 Documents a Settings 2 ig Recycle Bini Psat BGO Y pkey 3 06 PM Figure 8 Ro eee Type the name of a program Folder document or _ Internet resource and Windows will open it For you Open powercFa cpl Cancel Browse Figure 9 GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 13 8100802 5 06 14 i Operating Instructions MB 11 MAICO If you use a desktop computer select Home Office Desk within the Power Schemes and select
16. M MB11 Carpenter BG Born 9 13 2011 Age 44 day s File Settings About MAICO are Patient EO es Born Last name First name M d yyyy ee G a a Oa Pat ID Screener i E Tracking na MB 11 Classic with EAR 3A s n 0047594 10 27 2011 Figure 30 MB 11 Today s list If several tests will be conducted in one day it may be easier to enter the data of all babies before you start to test In this case click on the button New data and enter the name birthdate ID and sex as described in chapter 5 6 If you are saving additional information for HiTrack click on the Tracking button and enter this additional data as well After all the desired data is entered click on the button Add to Today s list Now click again on the button New data 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 so that you can select the desired name After selecting the baby to be tested select the ear to be tested right R or left L or Binaural and start the test by clicking on the button Measure For the test procedure refer to chapter 6 Names entered into Today s List will remain until at least one test has been initiated on the patient or until 48 hours have elapsed GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b
17. SB driver Tiles Please note that you need administration rights for software installation Install the MB 11 software before connecting the MB 11 to the USB port on the computer After installation of the MB 11 software connect the MB 11 to the USB port of your PC and check that the red LED on the MB 11 pre amplifier 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 4 1 above about using USB ports After a few seconds the system will show a message about a newly found USB device MAICO MB 11 Allow the wizard to install the MB 11 driver if necessary 4 3 Minimum computer specifications Processor Intel Pentium 800 MHz compatible or better RAM 256 MB Hard disk 2 GB Interface USB 1 1 or 2 MB 11 requires a USB port with 500 mA dc current over the VUSB line Display SVGA 800x600 Grounded power supply Operating system Windows XP SP 1 or later Windows 2000 SP 4 or later Windows 7 Professional or Windows 8 Pro GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 8 8100802 5 06 14 i Operating Instructions MB 11 MAICO 4 3 1 Power supply NOTE The PC used with the MB 11 must either be grounded or the laptop must be in used in battery mode Use only protective earth conductor plugs and wiring for the power supply The lack of grounding will lead to enhanced humming noise with a large affect on the measurement qualit
18. _14b 52 Operating Instructions MB 11 The MB 11 Classic is an active diagnostic medical product according to the class Ila of the EU medical directive 93 42 EEC IEC 60601 1 IEC 645 3 IEC 645 7 Type 2 Screening CE Chirp Stimulus Screening 93 s Screening 35 dB nHL 125 1250 Hz Integrated 87 dB amplification 23 000 x 16 kHz Integrated indicator in Pre amp unit and display in software with signal quality display or with EEG 15 to 35 4 59 to 95 F max humidity 75 5 to 50 C 41 to 122 F max humidity 90 ER 3A insert phones with EarCup adapter Disposable snap Integrated indicator red signal quality low green signal quality OK 300 g 8100802 5 06 14 M Operating Instructions MB 11 MAICO Instrument MB 11 Box Power Supply via USB port of computer Power Consumption max 400 mA Weight 1659 Dimensions WxDxH 12x9x3 cm Computer requirements computer not included Type Intel Pentium Ill 800 MHz compatible or better RAM minimal 256 MB RAM Hard disk Minimal 2 GB Interface USB 1 1 or 2 Display SVGA Colour Display 800x600 or Operating system GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b better Windows 2000 SP 4 Windows XP SP 1 or later Windows 7 Professional 32 64bit Windows 8 Pro 32 64bit 53 8100802 5 06 14 M Operating Instructions MB 11 MAICO Mains supply Use only protective earth conductor plugs and wiring for the power supply
19. acking feature these fields are not exported through this function In a spreadsheet this file should be viewed as a comma delimited Tile 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 Tile that is formatted according to the selection of either OZ or HiTrack set in the Options dialog A Windows browser will appear to allow you to define the path and filename to which the data will be saved This file can be merged into HiTrack or OZ You must have purchased these third party databases trom HiTrack or OZ and you must follow their procedures for merging the data in these export Tiles 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 5 4 2 Menu Settings M MB11 unnamed Save Test settings Saves configurable test settings Fie EARS about as user selected defaults Menu item Is only available for n 4 selection from within the Measurement screen Options Reset settings to default Figure 25 Resets configurable test settings to the original defaults gt ettings Menu Menu item is only available for selection trom within the Measurement screen Options Figure 25 This dialog allows you to define a number of user se
20. am test result PASS not achieved after 180 seconds of artifact tree EEG sampling the test is terminated with a REFER result Please see section 11 for additional scientific background on the stimulus and algorithm used with the MB 11 device Pass Neither the algorithm nor critical test values are adjustable by the user GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 8100802 5 06 14 i Operating Instructions MB 11 MAICO 4 Installation and Settings 4 1 USB Specifications The MB 11 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 separate power supply do not work with the MB 11 hardware 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 MB 11 does not work or interferes with the function of simultaneously 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 up process Please note that the MB 11 is only supported by MS Windows 2000 SP4 and above and MS Windows XP SPland above Windows 7 Protessional and Windows 8 Pro The following installation guide is based on the use of MS Windows XP MS Vista is not supported Install the MB 11 Software with the U
21. ass 6 6 6 GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 1 M Operating Instructions MB 11 Page N9 _ gt OWONWOUWOUOMMWAA WA maoa A A W NON N NO NN PUW 24 8100802 5 06 14 i Operating Instructions MB 11 MAICO 6 4 5 Test result Refer 44 6 5 Binaural Screening 45 6 5 1 Preparing tor a Binaural Screening 46 6 5 2 Binaural Screening Result 46 7 Tracking 48 7 1 Tracking Settings 48 7 2 Input of Tracking data 49 7 3 Advanced Tracking data 50 7 4 The export functions of the MB 11 database no tracking enabled 50 7 5 The export functions of the MB 11 database Tracking enabled 51 8 Technical Data 52 9 Scientific Background Information 55 9 1 CE Chirp Stimulus 55 10 Warranty Maintenance and After Sales Service 59 11 Safety Regulations 60 GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 2 8100802 5 06 14 M Operating Instructions MB 11 MAICO 1 Introduction Thank you for purchasing a quality product trom the MAICO family This automatic ABR test system MAICO MB 11 Classic is manufactured to meet all quality 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 functio
22. asurement Quit MB 11 BERAphone s n 0057602 10 7 2011 Figure 38 MB 11 program Test result REFER If 100 of the pass criteria is not reached after 180 seconds of data collection time the test is automatically terminated and a REFER will be displayed below and to the right of the graph In this case follow your screening program protocol to determine whether another screening should be performed or whether the baby will be referred for a diagnostic follow up test When you leave the test screen by clicking on the button QUIT the test result will be stored automatically in the data base GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 44 8100802 5 06 14 M Operating Instructions MB 11 MAICO M har File Settings About MAICO _ EEG Passcriteria Ab ort Stimulus Level 35 dBnHL 0 10 20 30 40 50 0 90 100 110 120 130 140 150 160 170 180 Test Time s Notes Abort Other Ear Start Measurement MB 11 BERAphone s n 0057602 10 7 2011 Figure 39 Test result Abort If the test is aborted by manual selection of the Stop Measurement button or the Quit button by the screener the test will be documented as an Abort If Tracking is enabled a pop up window will display to allow selection of a reason for termination After confirming a reason the result Abort with reason is shown in the green area see Figure 39 When you leave the test screen by clicking on the bu
23. best EEG quality The top of the test screen shows the impedance traffic light Figure 33 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 and red signals poor impedance The impedance values measured for Vertex Ground and Nape Ground lines are shown in the status line in the lower left corner at the screen In case of red light the impedance needs to be corrected Check the connection of the electrode to this site and if necessary use additional skin preparation material to clean the site better In some cases it takes a few seconds until the electrode gel takes effect The impedance test is passed when all three electrodes show green or yellow for approximately 7 seconds After passing the impedance test the measurement starts automatically and the impedance traffic light changes into the signal quality traffic light GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 39 8100802 5 06 14 Operating Instructions MB 11 6 4 2 The signal quality control MAICO O t6 Notes Test in progress Notes Test in progress Figure 34 MB 11 program test screen showing bad and good signal quality The signal quality is determined by the ratio of artifacts versus accepted samples of EEG data Artifacts are large potentials that are rejected during the recording They can be caused by electrical noise in the environ
24. c_EarCups_3 18_e_14b 50 Figure 46 Load from Database 8100802 5 06 14 i 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 an OZ or Hilrack 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 Figure 47 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 Tracking Export area A browser dialog will open allowing you to type in the name of the export Tile and the location for storage Be sure that the filename and extension you enter here is the one that OZ or Hilrack figure 47 will be looking for to merge the data You Load from Database can limit the list of exported data using the various search filters described In section 5 5 1 GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 51 8100802 5 06 14 M MAICO 8 Technical Data CE 0123 Standards Test signals Stimulus rate Stimulus intensity EEG filter Preamplifier Sample rate Quality control Operation conditions Storage conditions Transducer Electrodes Quality control Weight GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e
25. damage is suspected Do not immerse the unit in any fluids See the Cleaning section of this manual for proper cleaning procedures Use and store the instrument indoors only Do not expose this instrument or its accessories 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 manufacturer for all service Opening the instrument case will void the warranty The MAICO MB 11 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 operating conditions The presence of normal evoked potentials 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 indications 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 Use only Sanibel EarCups The device is only calibrated to this ear coupler If other ear coupler or in the ear insert phones are used the stimulus is not applied anymo
26. dealer Additionally it is recommended to adjust the value of system performance inside the system control to optimal GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 20 8100802 5 06 14 M Operating Instructions MB 11 MAICO 5 Getting started 5 1 Unpacking your instrument Your MB 11 Classic was carefully inspected and packed for shipping However it Is good practice to thoroughly inspect the outside of the shipping box for signs of damage 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 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 accessories MB 11 Classic e MB 11 Classic with pre amplitier e Box of Infant Ear Cups and snap electrodes e Electrode cable kit for snap electrode 3 pcs Black Yellow White e ER 3A Insert Phones e EarCup adapters 2 pcs e Nuprep abrasive skin preparation
27. e electrode placement points the high forehead temple or cheek and nape of the neck 6 3 Placement of EarCups IMPORTANT NOTES Insert earohones can be used only with EarCups that adhere to the skin around the ear The EarCup adapter need to be attached at the end of the insert earphone tubing to connect them properly to the EarCups Changing to in the ear insert phones or other disposables without proper calibration of your device will result in inaccurate test results due to calibration differences needed for different disposables There is a RIGHT ear and a LEFT ear insert earphone It is important that you match the insert earphone to the correct ear for the results to be assigned to the proper ear in the database For the right ear the red insert phone tube is used and Tor the left ear the blue one 6 3 1 Insert earphone tubing and adapters Verify that the tubing and adapter installed onto the insert phones correspond to the EarCup disposables 6 3 2 Use of adhesive EarCup couplers To apply the stimulus to the babies ear adhesive EarCups that surround the baby s ear are used Remove the card with the EarCups from the package Peel the EarCup off of the backing card and place it around the baby s ear with the opening for the insert phone tube adapters positioned at the top of the baby s ear Gently apply pressure around the circumference of the EarCup to adhere the EarCup to the baby s skin Repeat this process with the s
28. econd EarCup placed on the other ear Insert the insert phone tube adapters into each of the EarCups GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 35 8100802 5 06 14 i Operating Instructions MB 11 MAICO Be sure that the EarCup attached to the Right insert earphone red is applied to the right ear Be sure that the EarCup attached to the Left insert earphone blue is applied to the left ear Make sure that the opening of the insert phone tube adapters are not blocked by the baby s ear and the insert phone tubes are not bended Otherwise the stimulus is not presented properly to the ear This can cause in wrong measurement results 6 3 4 Removal of disposables After the screening the electrodes and ear tips or EarCups should be removed trom the patient and discarded These disposables are intended for single patient use only Removal of the electrodes and EarCups may cause some temporary discomfort to the patient GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 36 8100802 5 06 14 i Operating Instructions MB 11 MAICO 6 4 Performing the screening test Fie Settings About MAICO MB 11 f Patient Born Last name First name M d yyyy 10 27 2011 77 O male Pat ID Screener Mary Smith female R Ear L os 1 Classic with EAR 34 s n 0047594 10 27 2011 Figure 31 MB 11 program start screen Enter or load patient data Prepare the patient and as described in chapter 6 1 and p
29. eed when the connected notebook computer is powered by batteries or the computers power supply accords to IEC 60601 1 or IEC 950 1 safety regulations and an isolation transformer meeting rt 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 MB 11 Classic computer and isolation transtormer is suitable for use In the patient environment 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 Classic cables must not be bend or buckled Do not use the instrument if the mains cable and or the outlet is damaged Patient safety Place the patient at least 1 5 m away trom Notebook or computer Alternatively work in battery mode use a Medical PC or a special mains adapter according IEC 60601 1 GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 4 8100802 5 06 14 Operating Instructions MB 11 Precautions Disclaimer A A 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 damaged return it to the manufacturer for repair and or calibration Do not use the instrument if any
30. gel e USB cable e Carrying bag e USB drive with MB 11 software e Operation Manual GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 2 1 8100802 5 06 14 i Operating Instructions MB 11 MAICO 5 2 Preparing the MB 11 for use The MB 11 unit consists of a USB interface box connected with the MB 11 Classic preamplifier by a cable A USB cable connects the MB 11 interface box with a USB port of a mobile or desktop computer Electrode leads GY P MB 11 box Preamplifier n Figure 22 MB 11 Classic with electrodes and Sanibel EarCups The MB 11 s power is directly supplied through the computer via the USB port No external power supply is needed Sanibel EarCups The insert earphones and electrode leads plug into jacks in the preamplifier see Figure 22 The MB 11 like any hearing screening device should be operated in a quiet room so that the screening results are not negatively intluenced by outside acoustic noises Electro medical instruments with strong electromagnetic fields e g microwaves radiotherapy devices can influence the function of the MB 11 Classic Therefore the use of these instruments in close proximity to the MB 11 Classic should be avoided 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 GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 2
31. h the addition of a large number of cosines with a fixed frequency difference The frequency difference is selected in accordance with the desired stimulus repetition rate Amplitude O Spectral ampltude dB Amplitude Spectral amplitude dB n du 0 5 10 15 20 25 30 35 40 0 250 500 750 1000 7250 7500 7750 6000 Time ms Freguenz Hz c Amplitude oOo Spectral ampitude dB Figure 49 Figure 49 a shows in the right panel the frequency spectrum of such a click Every component of the spectrum represents a cosine The difference between the single cosines is 90 Hz and is equal to the stimulation rate of 90 s A ripple between the individual pulses of the stimulus in the time domain shown in the left panel of Figure 49 a can be effectively reduced by halving the amplitudes of the cosines with the lowest and the highest frequency In contrast to the standard click generated in the time domain the new stimulus is a steady state signal GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 56 8100802 5 06 14 i Operating Instructions MB 11 MAICO The patented stimulus constructed from individual cosines offers the possibility of introducing a trequency dependent phase correction in order to compensate for the propagation time in the cochlea From this phase correction a synchronized activation of the whole basilar membrane can be expected Figure 49 b shows to the left the time course of a phase corrected click The c
32. he EEG display mode can be accessed by clicking on the EEG checkbox on the lett 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 baby and electrical conditions in the environment are quiet When the baby becomes active 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 activity 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 indicate that the electrode gel trom two sites on the baby s head have merged This can negatively affect the quality of the recording Fie Settings About MAICO EEG EEG uv 1005 20 Time ms Stimulus Level 35 dBnHL 80 90 100 Test Time s Notes Test in progress ie st in progress 10 7 2011 Figure 35 Test screen with EEG view enabled GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 41 8100802 5 06 14 i Operating Instructions MB 11 MAICO At the bottom of the test screen are several function buttons M MB11 Carpenter BG Born 9 13 2011 Age 44 day s File Settings About MAICO Lise Signal Quality Stimulus Level 35 dBnHL 80 90 100 Test Time s 60 70 110 120 130 150 160 170 180 Notes Test in progress
33. hether the delay of the different models has to be considered to reflect the group delay or the phase delay of the cochlea The phase delay describes how much a steady state cosine of a specific frequency is delayed trom 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 contirmed the assumption that the latencies of the frequency specitic ABR reflect the group delay Since the stimulus shall compensate for the cochlear delay of single frequencies the phase delay calculated trom the group delay was used for the phase correction of the individual cosines of the stimulus Figure 49 c shows the time course of the resulting CE Chiro Stimulus For preventing an overlapping of response harmonics by electrical artifacts the above described frequency offset has to be added too GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 57 8100802 5 06 14 Operating Instructions MB 11 CE Chirp Rel Amplitude arb units 0 5 Time ms Figure 50 Extensive investigations on newborns have shown that the CE Chirpo Stimulus generates significant better results than other acoustical stimuli used for newborn hearing screening At 35 dBnHL stimulus level usually used for automatic ABR newborn hearing screening we found a high specificity and short test time in newborns The combination
34. ing directory GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 48 8100802 5 06 14 i 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 MAICO MB 11 Patient Pe Born Last name First name Mid yyyy Pat ID Screener i USER_mis_ksm E Sa O female Figure 43 Start screen with function button Tracking data Click on the Tracking button to open the input window ae Patient data will be copied from the us a main screen am Time of brth rth weignt grams Fill out the form with the information see pa S pon your program tracks Click on the staus ipase nae ie advanced button to open the next S input window which contains at ee Nursery type Well baby additional fields as seen in Figure 44 et a a Figure 44 Tracking data GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 49 8100802 5 06 14 M MAICO 7 3 Advanced Tracking data Advanced Tracking data Mother s data Last name S Date of birth Phone 456 789 0123 City Town Zip code State Fest name i Maiden name Language English zi Address 1 Address 2 Risk indicator s Family history T Weight lt 1500g Iv Bact meningitis Ototoxic medic Iv Mech ventilation Iv Abnorm apgar sc T Operating Instructions MB 11 Stigmata Hyperbilirubinermia T Co
35. 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 file 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 trom 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 Tile 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 Tracking Export area OZ during collection a file will be continuously saved and appended to with each screening test This file will be in the format required by the OZ third party database which the customer must purchase from OZ This setting also impacts the Tracking export function that Is accessed in the Search dialog So there are two ways to create an OZ tracking Tile One occurs automatically when the OZ tracking function is enabled One is performed through a manual process by exporting based on a manually en
36. lace the electrodes as described in chapter 6 2 attach the adhesive EarCups 6 3 Select the ear to be tested To perform a simultaneous binaural test select the Ear button until it displays the word Binaural and the color of the button turn pink If the Binaural ear choice does not display check the Binaural Test Allowed setting in the Options menu to make sure that binaural testing Is enabled Next click on Measure The measurement screen opens see Figure 31 Tene ma Stimulus Level 35 dBnHL Notes Other Ear Figure 32 Start measurement Start the test by clicking on Start Measurement button GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 3 7 8100802 5 06 14 i Operating Instructions MB 11 MAICO Before the measurement is started an automatic impedance test is performed GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 38 8100802 5 06 14 Operating Instructions MB 11 6 4 1 Impedance Test MAICO F Ees NBII Hurra Bares Born Pe Stree Mas MAICO Qc Figure EE Impedance traffic lights at top of measurement window The impedance is the resistance between the measuring electrodes Vertex and Nape and the ground electrode This impedance is influenced by the resistance of the electrodes and the resistance of the skin The impedance should be in the range of 250 Ohm to 15 000 Ohm for each electrode reading Impedance in this range will allow the
37. lectable settings The item is only selectable from within the Main screen The fields in the Software Settings area include Language The program language can be changed to any of the available languages 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 Figure 26 Options The MB 11 database Tile includes all patient and test information as well as GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 25 8100802 5 06 14 i Operating Instructions MB 11 MAICO 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 selected 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 detault printing scheme and choose your desired screening tests for printing to the label printer 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
38. ment muscle activity related to movement of the baby muscle tension or loss of acceptable electrode impedance Excessive periods of artifact can prolong the test time and may increase the chance of a Refer result After the impedance test is completed and data collection begins the signal quality light is displayed at the top of the test screen Red indicates poor recording quality artifact yellow indicates fair quality and green indicates good signal quality When the signal quality meets conditions to display a yellow or green bar the test proceeds When the signal quality is poor red light then artifacts are occurring which in effect pauses data collection The signal quality indicator light on the MB 11 Classic amplifier box also shows a color indicator of signal quality that matches the display on the screen If the signal quality remains poor for a prolonged period check the contact of the electrodes to the skin If poor 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 pausing the data collection by pressing the PAUSE button and allow the baby to calm down before continuing the screening GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 40 8100802 5 06 14 M Operating Instructions MB 11 MAICO 6 4 3 EEG Display T
39. 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 i Select the power scheme with the most appropriate settings for this computer Note that changing the settings below will modify Ae selected scheme Power schemes Home Office Desk Running on batteries Turn off monitor Turn off hard disks System standby mea __ Figure 10 GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 14 8100802 5 06 14 i Operating Instructions MB 11 MAICO Select Hibernate within the menu bar and change Hibernate settings to off as shown in the picture 611 Service_Manual doc Microsoft Word Power Options Properties Power Schemes Alarms Power Meter Advanced Hibernate i When pour computer hibermates it stores whatever it has in mema on your hard disk and then shuts down When pour Disk space for hibernation Free disk space 3 603 MB Disk space required to hibemate n04 ME Figure 11 computer comes out of hibernation it returns to its previous state Hibernate If you use a Notebook computer select Portable Laptop within the Power Schemes and select as follows Plugged in Turn off monitor never Turn off hard disk never System standby never System hibernates never i Service_Manual doc Micr
40. ngen infection I Cranio facial anom Head trauma I Recu otitis media o Alternate contact NICU Iv Care giver concern Last name First name Phone Language English Relationship to mother city Town Address 1 Zip code Address 2 State Notes o O Figure 45 Advanced tracking data Syndr wf progr loss I Neonatal ind Exp date of birth Other Region unique ID ist tracking variable 2st tracking variable a ce 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 file 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 The Load from Database dialogue appears Figure 46 Choose the data for export using the filter fields and set the date range in the Date Export area Then click on the Export button appears A browser dialog will open allowing you to type in the name of the export Tile and the location for storage You can limit the list of exported data using the various search filters described in section 5 5 1 GEBA_8100802 5_MB_11_Classi
41. ns 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_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 3 8100802 5 06 14 i Operating Instructions MB 11 MAICO 2 Important safety instructions The MAICO MB 11 Classic is designed to be used only by skilled personnel Audiologists Physicians or other trained 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 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 e g microwaves radiotherapy devices can intluence the function of the MB 11 Classic Therefore the use of these instruments is not allowed in close proximity to the MB 11 Classic Electro medical instruments with strong electromagnetic fields 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 classic is specified according to IEC 60601 1 safety against electrical hazard This is only guarant
42. ocessed to determine its frequency content The ASSR is described in the frequency domain by a few spectral lines harmonics mathematically related to the stimulus rate of about 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 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 signal detection algorithm is associated with short test times as well as high immunity against distortion from electrical interference The detection algorithm enables simultaneous binaural measurements The stimulus for the left and right ear is presented with slightly different repetition rates The ASSR response of each ear have harmonics at different frequencies those can be detected separately by the detection algorithm GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 6 8100802 5 06 14 M Operating Instructions MB 11 MAICO 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 second until the overall test result arrives at critical value the green marked PASS criteria see figure 2 Then the test will be stopped with the test result PASS If the PASS criterion is ae progr
43. of the CE Chiro and the Standard leads to very short examination times for newborn hearing screening Click evoked ABR at high stimulus repetition rates for neonatal hearing screening Sturzebecher E Cebulla M and Neumann K Int J Audiol 42 2 59 70 2003 GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 58 8100802 5 06 14 i Operating Instructions MB 11 MAICO 10 Warranty Maintenance and After Sales Service The MB 11 Classic ABR Screener is guaranteed for 2 year This warranty is extended to the original purchaser of the instrument by MAICO through the Distributor from whom it was purchased and covers detects in material and workmanship tor a period of one year from date of delivery of the instrument to the original purchaser The MB 11 Classic may be repaired only by your dealer or by a service center recommended 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 MB 11 should be checked and calibrated at least once a year This check must be performed by an authorized MAICO dealer When returning the instrument for repairs it is essential to send all the components Send the device to your dealer or to a service center authorized by your dealer Please include a detailed descripti
44. on 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_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 59 8100802 5 06 14 i Operating Instructions MB 11 MAICO 11 Safety Regulations 14 1 Electrical Safety The MB 11 Classic ABR Screener is S specified to comply with the international standard IEC 60601 1 EN 60601 1 The MAICO MB 11 Is guaranteed according to IEC 60601 1 safety against electrical hazard only when the connected notebook computer is powered by batteries or the computers power supply accords to IEC 60601 1 or IEC 950 1 safety regulations The instruments are not intended for operation in areas with an explosion hazard 14 2 Measuring security To guarantee that the instrument works properly it has to be checked at least once a year The service and calibration must be performed by an authorized service centre In accordance with the regulations of the EU medical directive we will drop our liability if these checks are not done 14 3 Device control The user of the instrument should perform a 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 Classic i
45. orresponding amplitude spectrum is shown at the right side The red arrows mark the position of the first six spectral harmonics of the brainstem response evoked by the phase corrected stimulus These harmonics were analyzed by the objective statistical test Implemented in the automatic test algorithm of the MB 11 software It is easy to see that five of the six harmonics of the brainstem responses are overlapping with the stimulus frequencies This overlapping could lead to false results of the statistical test when electrical stimulus artifacts occur For elimination of this source of error a frequency offset is introduced into the cosines This frequency offset causes a displacement of the stimulus frequency spectrum In the time domain the frequency offset leads to an alternating stimulus With this 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 trom de Boer is based on measurements 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 optimal For this reason a new model function of the frequency dependent propagation time in the cochlea was calculated based on the latency data of frequency specitic ABR recorded at low stimulus levels In this context the question arises as to w
46. osoft Word o Edit View Insert Format Tools Table Window Help Adobe PDF Power Options Properties 2 x Power Schemes Alarms Power Meter Advanced Hibernate i Select the power scheme with the most appropriate settings for A this computer Note that changing the settings below will modify the selected scheme Power schemes Portable Laptop Save As Delete Settings for Portable Laptop power scheme When computer is E Running on i Plugged in Never After 30 mins Never After 30 mins Turn off monitor Turn off hard disks System standby Cancel Apply Figure 12 GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 15 Running on batteries after 30min after 30min never never 8100802 5 06 14 MAICO iY 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 iPower Options Properties 2 x Power Schemes Alarms Power Meter Advanced Hibernate When your computer hibermates it shores whatever it has in memory on your hard disk and then shuts down When your computer comes out of hibernation it returns to its previous state Hibernate T Enable hibernation Disk space for hibernation Free disk space 3 803 MB Disk space required to hibernate n04 ME cereal Ansly _ Fig
47. p 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 without 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 5 4 3 Menu About Click on About to see product information about the software version and contact information GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 28 8100802 5 06 14 i Operating Instructions MB 11 MAICO 5 5 Operation with mouse and keyboard or touch screen The MB 11 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 l
48. program Folder document or Internet resource and Windows will open it For vou Cancel Browse Figure 18 Display Properties x Themes Screen Saver Appearance Settings 4 theme iz a background plus 4 set of sounds icons and other elements to help You personalize your computer with one click Theme Windows Classic save As Delete Sample io xi Normal Disabled Selected Window Text a Figure 19 GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 19 8100802 5 06 14 i Operating Instructions MB 11 MAICO Display Properties x Themes Desktop Screen Saver Appearance Settings Browse Position Stretch Color il Bliss eee Customize Desktop mea os Figure 20 Display Properties x Themes Desktop CScreen Saves Appearance Settings Screen saver windows XP Settings Freeview None T FiweBo tume password protect 30 Flying Objects 3D Pipes power settings and save energy hy Pictures Slideshow Power Mystify Starfield Windows sP Cancel Apply Figure 21 4 4 5 BIOS Setup Because the MB 11 software uses real time and processor intensive algorithms we recommend 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
49. re with the correct level No relibale results will be obtained GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 5 8100802 5 06 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 generalized 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 MB 11 Classic The MB 11 Classic uses standard disposable electrodes to record an auditory brainstem response ABR Sanibel EarCups are used to deliver the acoustic stimulus The MB 11 performs a fixed intensity 35 dB _ NHL ABR screening It is particularly suited for Figure 1 newborn hearing screening Testing with MB 11 Classic 3 3 Automatic Screening with the ASSR Algorithm 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 pr
50. s designed to be used only by skilled personnel Audiologists physicians or other trained 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 GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 60 8100802 5 06 14 Operating Instructions MB 11 Specifications are subject to change MAICO Diagnostic GmbH Salzufer 13 14 10587 Berlin Germany Tel 49 3070 71 46 50 Fax 49 30 70 71 46 99 MAICO E mail sales maico biz Internet Wwww maico biz GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 61 8100802 5 06 14
51. t TAB gt key from field to field Pressing the Enter key activates the selected 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 i e to start the measurement press the keys lt ALT gt and lt M gt together Keyboard short cuts Alt F File Alt S Settings Alt A About AIt N New Alt C Search Load trom Database Alt T Add to Today s list Alt R Right Ear Alt L Lett Ear Alt 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 MB 11devices Ctrl B Beep at the end of the measurement Ctrl E Open close the screener field Ctrl W Automatic closing of test distortion message GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 29 8100802 5 06 14 i Operating Instructions MB 11 MAICO There are also several shortcuts accessible by using the Function keys F1 Help F2 Add to Today s List F3 Display Today s List F4 Ear Other Ear F5 Measure Start Measurement F6 Advanced Display On Off F7 Pause Continue F8 Stop Measurement F9 Print F10 Quit F11 Beep at end of test On Off GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 30 8100802 5 06 14 i Operating Instructions
52. tered date range entered in the Search dialog Tracking Export area Tracking File Name Allows the user to define the desired name for the tracking Tile that is saved automatically during data collection GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 2 8100802 5 06 14 i Operating Instructions MB 11 MAICO Tracking Path Allows the user to define the desired data path for saving of the automatically 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 collection 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 that 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 preferences related to testing when the hardware being used is the MB 11 Classic rather than the BERAphone This control will only show u
53. 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 exponentially towards the apex Frequency Hz Time ms Figure 48 Figure 48 shows the delay of the travelling wave for reaching the various frequency bands in the cochlea calculated trom the cochlea model of de Boer The figure shows a delay shorter than 2 ms for the region trom 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 traveling wave delay in the more apical part of the GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 55 8100802 5 06 14 i Operating Instructions MB 11 MAICO cochlea is responsible for considerably dispersed responses from this area For this reason the spatio temporally summated response does not achieve the amplitude that would result from a more synchronous excitation The new CE Chirp Stimulus implemented in the MB 11 Classic allows a well synchronized activation of the whole cochlea In contrast to the conventional generation of a click in the time domain in the frequency domain a click like stimulus can be created throug
54. tions MB 11 MAICO EEG Enabling the EEG checkbox replaces the signal quality indicator light with a display of ongoing EEG activity 6 4 4 Test result Pass M MB11 Grow Grow Born 9 5 2011 Age 32 day s ing File Settings About MAICO EEG Passcriteria Stimulus Level 35 dBnHL 0 30 100 Test Time s 60 70 110 120 130 150 160 170 180 Notes Pass Other Ear Start Measurement Quit MB 11 BERAphone s n 0057602 10 7 2011 Figure 37 MB 11 program Test result PASS During the test a small segment of a line is drawn after each 1 second of data collection The line displays as blue for a left ear test and red for a right ear test Progress toward reaching the criteria for a Pass result is indicated by the movement of the line upward toward the green area of the graph When the line reaches the green area a PASS result displays inside the green area see Figure 37 When you leave the test screen by clicking on the button QUIT the test result will be stored automatically in the data base Selecting Quit during active data collection will terminate the data collection with an Abort outcome GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 43 8100802 5 06 14 i Operating Instructions MB 11 MAICO 6 4 5 Test result Refer TAAN Burns Fie Settings About MAICO _ EEG Stimulus Level 35 dBnHL 90 Test Time s Notes Refer Other Ear Start Me
55. tton QUIT the test result will be stored automatically in the data base GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 45 8100802 5 06 14 i Operating Instructions MB 11 MAICO 6 5 Binaural Screening With the MB 11 Classic simultaneous binaural testing is possible This allows both ears to be screened at the same time Testing will continue until both ears achieve a Pass result or until one or both ears test terminates in a Refer result To perform a binaural test the setting Binaural Test Allowed in the Options dialog must be enabled Otherwise the selection of Binaural in the ear button control will not be possible 6 5 1 Preparing for a Binaural Screening Prepare the patient as described in chapter 6 but apply the disposable ear tios or EarCups for both ears Select the Ear button on the Main window or the Other Ear on the measuring screen until Binaural in pink letters is displayed Click on Start Measurement to begin measurement The stimulus and the data collection will begin for both ears simultaneously 6 5 2 Binaural Screening Result Unlike monaural test the binaural measurement will display two colored lines red for the right ear and blue for the left Both ears are screened for hearing loss at 35dBnHL If responses are detected from both ears the lines move upward until it reaches the 100 area colored green then the result will be shown as PASS M MB11
56. ure 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 i BERAphone j idit View Favorites Tools Help Power Options Properties 2 xi Power Schemes Alarms Power Mete Hibernate el 13 Select the power saving settings you want to use Options I Always show icon on the taskbar Prompt for password when computer resumes from standby M Power buttons When close the lid of my portable computer Do nothing When press the power button on my computer Shut down x When press the sleep button on my computer Shut down v Cancel Apply Figure 14 GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 16 8100802 5 06 14 A Operating Instructions MB 11 MAICO 4 4 3 Change visual effects Optional at low power PC To change visual effects select Run within the START column type sysdm cpl and contirm 2 x Type the name of a program Folder document or rh Internet resource and Windows will open it For vou Open sysdm cpl Cancel Browse Figure 15 System Properties ag x System Restore Automatic Updates Aemote General Computer Hame Hardware C Advanced You must be logged on as an Administrator to make most of these changes Performance Visual effects processor scheduling memon usage and virtual memory
57. ured 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 calendar controls and export patients and tests performed in this date range to a Tile that can be read in a spreadsheet program such as MS Excel A Windows browser will appear 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 Information GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 24 8100802 5 06 14 i Operating Instructions MB 11 MAICO contained in the txt Tile includes ID No as entered by the user Name last First 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 tr
58. vmgmt mse Cancel Browse Figure 4 Select Universal Serial Bus controllers and then select a listed USB Root Hub Double click to open the Properties and select the Power Management tab of the Properties dialog Remove the check mark if preselected Don t allow the computer to turn off this device to save power GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 10 8100802 5 06 14 iY Operating Instructions MB 11 MAICO o x mj Device Manager File Action View Help H Computer Se Disk drives B Display adapters 4 DYDICD ROM drives f Floppy disk controllers H Floppy disk drives f IDE ATALATAPT controllers a Keyboards 1 Mice and other pointing devices 2 Monitors EE Network adapters F Ports COM amp LPT E Processors DEC SCSI and RAID controllers Fe Sound video and game controllers Fl i System devices E Universal Serial Bus controllers Figure 5 iolx File Action View Help z F Computer Set Disk drives B Display adapters vaa DYDICD ROM drives Floppy disk controllers A Floppy disk drives f IDE ATASATAPT controllers a Keyboards 1 Mice and other pointing devices Monitors H8 Network adapters H Ports COM amp LPT EJ i Processors DEC SCSI and RAID controllers H Sound videa and game controllers E System devices Universal Serial Bus controllers Figure 6 GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 11
59. y The buzzing noise also affects the audio output of computers and produces a masking noise signal This will falsity 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 accessory 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 4 4 Operating system settings To get the best possible performance tor the MB 11 Classic it might be necessary to change the properties of the computer notebook systems used A description of these settings is provided below 4 4 1 Deactivate save power USB hubs Therefore select Run within the START column type devmgmt msc and contirm GEBA_8100802 5_MB_11_Classic_EarCups_3 18_e_14b 9 8100802 5 06 14 A Operating Instructions MB 11 MAICO iby basia fei etal ate alate Mey Jai LM Caia 0 8 Neues Office Dokument a Office Dokument ffnen ES windows Catalog Databook Windows Update Set Program Access and Defaults SS WinRAR exe Programs A Documents Da Recycle Bin Figure 3 I Type the name of a program Folder document or Internet resource and Windows will open it For vou Open de

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