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Operation Manual MB 11 Classic

8100498-4_OM_MB11_Classic_3.18_EN_16a.docx

01/16

Specifications are subject to change without notice.

MAICO Diagnostics GmbH
Sickingenstr. 70-71
10553 Berlin
Germany
Tel.:       + 49 30 / 70 71 46-50
Fax:       + 49 30 / 70 71 46-99
E-mail:   [email protected]
Internet: www.maico.biz

Summary of Contents for MB 11 Classic

Page 1: ...Operation Manual MB 11 Classic...

Page 2: ......

Page 3: ...ay Properties 18 4 4 5 BIOS Setup 19 5 Getting started 20 5 1 Unpacking your instrument 20 5 2 Preparing the MB 11 for use 21 5 3 Device Recognition 22 5 4 Menus 23 5 4 1 Menu File 23 5 4 2 Menu Setti...

Page 4: ...king enabled 49 7 5 The export functions of the MB 11 database Tracking enabled 50 8 Follow up measurements 51 8 1 Testing with the Time Step Stimulus 52 8 1 1 The Time Step Stimulus 52 8 1 2 Testing...

Page 5: ...cording 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 becau...

Page 6: ...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 601 1 safety against electrical hazard This is only guara...

Page 7: ...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 Disclaimer The MAICO MB 11 Test Instrument i...

Page 8: ...a fixed intensity 35 dB nHL ABR screening It is particularly suited for newborn hearing screening 3 3 Automatic Screening with the Fast Steady State Algorithm The acoustical CE Chirp stimulus is prese...

Page 9: ...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 not achieved after 180 seconds of artifact free...

Page 10: ...llowing installation guide is based on the use of MS Windows XP MS Vista is not supported Install the MB 11 Software with the USB driver files Please note that you need administration rights for softw...

Page 11: ...ode 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 suppl...

Page 12: ...16 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...

Page 13: ...Operation Manual MB 11 Classic 8100498 4_OM_MB11_Classic_3 18_EN_16a docx 11 01 16...

Page 14: ...N_16a docx 12 01 16 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...

Page 15: ...Operation Manual MB 11 Classic 8100498 4_OM_MB11_Classic_3 18_EN_16a docx 13 01 16 4 4 2 Change Power Options To change power options select Run within the START column type powercfg cpl and confirm...

Page 16: ...assic 8100498 4_OM_MB11_Classic_3 18_EN_16a docx 14 01 16 If you use a desktop computer select Home Office Desk within the Power Schemes and select never Turn Off monitor never Turn off hard disk neve...

Page 17: ...nd change Hibernate settings to off as shown in the picture If you use a Notebook computer select Portable Laptop within the Power Schemes and select as follows Plugged in Running on batteries Turn of...

Page 18: ..._16a docx 16 01 16 Select Hibernate within the menu bar and change Hibernate settings to off as shown in the picture Select Advanced within the menu bar and change Advanced settings to When I close th...

Page 19: ...anual MB 11 Classic 8100498 4_OM_MB11_Classic_3 18_EN_16a docx 17 01 16 4 4 3 Change visual effects Optional at low power PC To change visual effects select Run within the START column type sysdm cpl...

Page 20: ...8_EN_16a docx 18 01 16 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 back...

Page 21: ...ntensive 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 yo...

Page 22: ...e 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 C...

Page 23: ...The MB 11 like any hearing screening device should be operated in a quiet room so that the screening results are not negatively influenced by outside acoustic noises Electro medical instruments with...

Page 24: ...he MB 11BERAphone and the MB11 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 open...

Page 25: ...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...

Page 26: ...urchased these third party databases from HiTrack or OZ and you must follow their procedures for merging the data in these export files into their databases Print The function implemented by selection...

Page 27: ...e 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...

Page 28: ...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...

Page 29: ...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 up in the dialog if an MB 11 Classic is attached...

Page 30: ...reen Keyboard short cuts can also be used for fast operation Press the ALT key together with the underlined letter of the required button i e to start the measurement press the keys ALT and M together...

Page 31: ...here 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...

Page 32: ...y fields using the tab 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...

Page 33: ...he name with the mouse or highlight the desired name and select the OK button If a test result already exists for this patient the button Show Measurements on the right of the screen see Figure 10 bec...

Page 34: ...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 yo...

Page 35: ...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 locatio...

Page 36: ...Insert earphones IMPORTANT NOTES Insert earphones can be used with in the ear disposable eartips or on some systems with EarCups that adhere to the skin around the ear The adapter tips at the end of...

Page 37: ...likely to fall out during the test so a secure placement is important While it is possible to perform a screening test in both ears simultaneously using the MB11 Classic it is sometimes a challenge t...

Page 38: ...the compatible insert earphone tube adapters into each of the EarCups Peel the EarCup off of the backing card and place it around the baby s ear with the adapter tube positioned at the top of the baby...

Page 39: ...tested To perform a simultaneous binaural test select the Ear button until it displays the word Binaural If the Binaural ear choice does not display check the Binaural Test Allowed setting in the Opt...

Page 40: ...The green color symbolizes good impedance yellow means not optimal and red signals poor impedance The impedance values measured for Vertex Ground and Mastoid or Nape Ground lines are shown in the sta...

Page 41: ...ty 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 occu...

Page 42: ...ditions 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...

Page 43: ...earphones 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 th...

Page 44: ...ft 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 reache...

Page 45: ...rminated 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...

Page 46: ...er 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...

Page 47: ...he patient as described in chapter 6 but apply the disposable ear tips or EarCups and insert earphones for both ears Select the Ear button on the Main window or the Other Ear on the measuring screen u...

Page 48: ...FER 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...

Page 49: ...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 file that can be exporte...

Page 50: ...s on the start screen Click on the Tracking button to open the input window Patient data will be copied from the main screen Fill out the form with the information your program tracks Click on the adv...

Page 51: ...be exported as text file 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 Databa...

Page 52: ...k Search on the start screen The Load from Database dialogue appears Fig 30 Choose the data for export using the filter fields set the date range in the Tracking Export area and click the Export butto...

Page 53: ...of REFER has occurred 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 condit...

Page 54: ...the step stimulus uses packets of 6 clicks following each other very rapidly in which the intensity increases in 10 dB increments for each click in the packet figures 32 and 33 As the entire click pa...

Page 55: ...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 m...

Page 56: ...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...

Page 57: ...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 consi...

Page 58: ...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 curves on the screen The cut off frequencies of the fil...

Page 59: ...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 41 will appear In contrast to the time step stimulus the Standard ABR will on...

Page 60: ...ake sure the instrument is clean and the tubing are free of clogging from dirt or oil Make sure that the cables are not broken or tangled or oppressed in any manner as this may destroy the wire embedd...

Page 61: ...A quiet sleeping baby is most conducive to a high quality screening Calm the baby with a pacifier if appropriate Position the baby so he she is comfortable and in a way to release any tension in the...

Page 62: ...Check that the insert earphone eartip remains securely inserted into the baby s ear canal s If you are using the EarCups check that they are in contact with the baby s skin around the entire circumfe...

Page 63: ...lus intensity Screening 35 dB nHL Time Step and Standard ABR 0 70 dB nHL EEG filter 125 1250 Hz Time Step and Standard ABR Preamplifier Integrated 87 dB amplification 23 000 x Sample rate 16 kHz Quali...

Page 64: ...later Windows 7 Professional 32 64bit Windows 8 Pro 32 64bit Mains supply Use only protective earth conductor plugs and wiring for the power supply The lack of grounding will lead to enhanced humming...

Page 65: ...l MB 11 Classic 8100498 4_OM_MB11_Classic_3 18_EN_16a docx 63 01 16 If it is necessary to use accessory devices while you operate in the battery mode ensure a separate continuous and sufficient ground...

Page 66: ...g the basilar membrane The traveling 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...

Page 67: ...a In contrast to the conventional generation of a click in the time domain in the frequency domain a click like stimulus can be created through the addition of a large number of cosines with a fixed f...

Page 68: ...is 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 sho...

Page 69: ...ave shown that the CE Chirp Stimulus generates significant better results than other acoustical stimuli used for newborn hearing screening At 35 dBHL stimulus level usually used for automatic ABR newb...

Page 70: ...ults 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 w...

Page 71: ...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...

Page 72: ...MB11_Classic_3 18_EN_16a docx 70 01 16 Specifications are subject to change without notice MAICO Diagnostics GmbH Sickingenstr 70 71 10553 Berlin Germany Tel 49 30 70 71 46 50 Fax 49 30 70 71 46 99 E...

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