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Operation Manual MB 11 Classic

8100498-4_OM_MB11_Classic_3.18_EN_16a.docx

01/16

11 Technical Data

The MB 11 Standard (Classic)

is an active, diagnostic medical product

according to the class IIa of the EU medical directive 93/42/EEC.

Standards:

IEC 601-1, IEC 645-3, IEC 645-7 Type 2

Test signals:

Screening: CE-Chirp™ Stimulus
Time Step Stimulus (Opt.): Chained Click
ABR (Opt.): Click

Stimulus rate:

Screening:  93/s
Time Step Stimulus:  20/s
Standard ABR:  14/s

Stimulus 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

Quality control:

Integrated indicator in Pre-amp unit and display in
software with signal quality display or with EEG

Operation
conditions:

+ 15 to + 35

C (+ 59 to + 95° F); max humidity

75%

Storage conditions:

+ 5 to + 50

C (+ 41 to + 122° F); max humidity

90%

Transducer:

ER3A insert earphones

Electrodes:

Disposable snap

Preamplifier:

Integrated, 87 dB Amplification (23.000x)

Quality control:

Integrated indicator red (signal quality low), green
(signal quality OK)

Weight:

300 g

Instrument

Содержание MB 11 Classic

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

Страница 2: ......

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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