Maico MB 11 BERAphone Operation Manual Download Page 75

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Operation Manual MB 11 BERAphone

/Classic

8100496 Rev. 6

23/10/2019

6 Technical Data

This section offers you important information about

▪

the MB 11 hardware specifications

▪

the pin assignment

▪

calibration values

▪

electromagnetic compatibility (EMC)

▪

electrical safety, EMC and associated Standards

MB 11 Hardware

The MB 11

is an active, diagnostic medical product according to the class

IIa of the EU medical directive 93/42/EEC.

General Information About Specifications

The performance and specifications of the device can only be guaranteed if it is
subjected to technical maintenance at least once per year.

MAICO Diagnostics puts diagrams and service manuals at the disposal of authorized
service companies.

STANDARDS

Medical CE-mark

Yes

Device Safety

IEC 60601-1:2005 + A1:2012
ANSI/AAMI ES60601-1: 2005 / A1/2,
Class II, Type BF applied parts
IEC 60601-2-40:2016

EMC

IEC 60601-1-2:2014 (EMC test done with default settings)

Calibration

ISO 389-6

ABR

IEC 60645-7:2009, Type 2

Summary of Contents for MB 11 BERAphone

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

Page 2: ......

Page 3: ...ce 13 Warranty 13 Maintenance 13 Cleaning and Disinfection Recommendations 14 Troubleshooting 19 Recycling and Disposal 21 4 Unpacking and Hardware Orientation 22 Unpacking the System 22 Use of Equipment after Transport and Storage 23 MB 11 Hardware and System Assembly 24 MB 11 Software Installation 25 Storage 37 5 Operating the PC Software 38 Getting Started with MB 11 Software 38 Preparing for T...

Page 4: ...cs Compliance MAICO Diagnostics is an ISO 13485 certified corporation Caution for USA Federal Law restricts this device to sale by or on the order of a licensed medical professional Trademark Notice CE CHIRP is a trademark by MAICO Diagnostics GmbH registered in the USA the European Union Switzerland and Norway Nuprep is a U S registered trademark of Weaver and Company Windows is a registered trad...

Page 5: ...automated ABR tests If you have questions or suggestions for further improvements please do not hesitate to contact MAICO Intended Use Statement The MAICO MB 11 BERAphone and MB 11 Classic are intended for use in the audiologic evaluation and documentation of ear and nerve disorders using auditory evoked potentials from the auditory nerve and the brainstem The devices are intended to be used for N...

Page 6: ...charging ear acute external auditory canal trauma discomfort e g severe otitis externa or occlusion of the external auditory canal Testing should not be performed on patients with such symptoms without a medical doctor s approval The BERAphone Classic 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 co...

Page 7: ...e MB 11 Software for ABR testing The MB 11 Classic can be used with EarCupsTM or eartips With integrated electrodes and speaker the MB 11 BERAphone provides a cost effective and environmentally friendly alternative for ABR based hearing screening ABR The MB 11 uses fast rate auditory brainstem response ABR technology to screen patients for hearing loss A modified click stimulus the CE CHIRP of 35 ...

Page 8: ...ication of electrode gel The only disposable supplies needed for screening with the BERAphone are electrode gel and disinfectant wipes to clean and disinfect the instrument after each baby is tested Figure 2 The BERAphone hardware is especially suited for infants The vertex electrode is located in an adjustable mounting allowing the distance to the ground electrode to be varied to adjust for diffe...

Page 9: ...commendations It is highly recommended that users read the manual in its entirety prior to use of the MB 11 device on a patient READ THIS ENTIRE MANUAL BEFORE ATTEMPTING TO USE THIS SYSTEM Use this device only as described in this manual All images and screenshots are only examples and may differ in appearance from the actual device settings In this manual the following two labels identify potenti...

Page 10: ...actured by or available from MAICO NOTE Customer responsibility includes proper maintenance and cleaning of the device see sections 3 2 to 3 4 and section 6 Breach of the customer responsibility can lead to limitations of Manufacturer s Liability and Warranty see sections 2 3 and 3 1 NOTE In the unlikely case of a serious incident inform MAICO aswellas your localdistributor Precautions for Patient...

Page 11: ...sult accompanying documents Warning consult accompanying documents Return to authorized representative special disposal required Reference number Patient applied part type BF according to IEC 60601 1 Refer to operation manual mandatory Keep away from rain Transport and storage temperature range Transport and storage humidity limitations Transport and storage atmospheric pressure limitations Voltag...

Page 12: ...representative Modification of the equipment could be hazardous No parts of the equipment can be serviced or maintained while in use with the patient Connect only accessories purchased from MAICO to the MB 11 Only accessories which have been stated by MAICO as being compatible are allowed to be connected to the device Electrical and Electrostatic Safety This icon indicates that patient applied par...

Page 13: ... be supplied via a separation transformer to reduce the leakage currents Any person who connects external equipment to signal input signal output or other connectors has formed a Medical Electrical System and is therefore responsible for the system to comply with the requirements If in doubt contact qualified medical technician or your local representative If the device is connected to a PC IT equ...

Page 14: ...1000 4 2 Use the device only in an electrostatic controlled environment The device fulfills the relevant EMC requirements Avoid unnecessary exposure to electromagnetic fields e g from mobile phones etc If the device is used adjacent to other equipment it must be observed that no mutual disturbance appears Please also refer to EMC consideration in section 6 4 The MB 11 has been verified by an indep...

Page 15: ...any faults by yourself or commissioning non experts to do so Do not modify this equipment without authorization of the manufacturer If this equipment is modified appropriate inspection and testing must be conducted to ensure continued safe use of the equipment No modification of this equipment is allowed In the event of repair during the guarantee period please enclose evidence of purchase with th...

Page 16: ...nfect the plastic housing of the MB 11 and its accessories by wiping the surfaces with wet disinfection wipes or a comparable product Follow the instructions on the specific disinfection product Wipe before and after each patient After contamination After infectious patients To avoid damage of the device and its accessories please mind the following Do not autoclave or sterilize Do not use the dev...

Page 17: ... cleaned and disinfected with a medical or hospital grade disinfectant prior to re use For a detailed description of cleaning and disinfection of the BERAphone see the following sections 3 3 3 2 to 3 3 3 4 3 3 3 2 Disinfectants Use of a non alcohol based disinfectant is recommended Non alcohol based products contain the active ingredient referred to as quaternary ammonia compound The quaternary am...

Page 18: ...infectant product b If the disinfectant wipe is very wet do not allow disinfectant to drip down into the black speaker inside the BERAphone 3 Disinfect any other components that touched the baby or the baby s bedding such as the cable BERAphone handle etc 4 Allow the disinfectant to dry thoroughly according to the manufacturer s instructions for maximum efficiency before using it on the next patie...

Page 19: ...ton tipped applicator to reach into the cavity to remove any gel inside 6 Allow the gel protector and stainless steel electrode to dry thoroughly and then re assemble 7 Inspect the inside of the fixed electrode post for any sign of electrode gel 8 If the stainless steel electrodes or the gel protectors cannot be adequately cleaned replace them with a new set of electrodes 9 Remove the ear cushion ...

Page 20: ...spring loaded pin and pressing them fully onto the pin 3 3 5 3 Replacement of Ear Cushions MB 11 BERAphone Only Replace the ear cushion with a new one as needed Replacement of the ear cushion is recommended at least every 3 months More frequent replacement of the ear cushion will be required if the facility uses an alcohol based disinfectant product Replacement cushions are available from MAICO or...

Page 21: ...electrode gel 2 Remove the BERAphone and massage a little more gel at the site Apply a little more gel 3 Use an electrode skin preparation product such as Nuprep or an electrode skin prep pad at the site wipe it off and then re apply gel to the site Measurement is running properly but with large regular EEG fluctuations Electrical artifact in environment or poor electrode contact 1 Check the conne...

Page 22: ...t poor signal quality during the screening 1 Check the state of the baby A quiet sleeping baby ismostconducive toa high qualityscreening Calm the baby with a pacifier if appropriate 2 Position the baby so he she is comfortable and in a way to release any tension in the neck A rolled up blanket tucked to support the baby s back and in the curve of the back and neck can help to release tension in th...

Page 23: ...arked with a crossed out wheeled bin Within the limits of Article 9 of DIRECTIVE 2002 96 EC on waste electrical and electronic equipment WEEE MAICO has changed their sales policy To avoid additional distribution costs we assign the responsibility for the proper collection and treatment according to legal regulations to our customers Non European countries Outside the European Union local regulatio...

Page 24: ... distributor immediately to report the shortage If any component appears to be damaged in shipment contact your distributor immediately to report it Do not attempt to use any component or device that appears to be damaged Reporting Imperfections Notify the carrier immediately if any mechanical damage is noted This will insure that a proper claim is made Save all packaging material so the claim adj...

Page 25: ...ectrodes 3 Cables Yellow White and Black Nuprep Abrasive Skin Preparation Gel with EarCupTM Infant EarCupsTM with Snap Electrodes EarCupTM adapter set with eartip Pack of disposable snap electrodes Disposable Eartips of Different Sizes Eartip adapter set Software Electronic Files CD or USB Drive with MB 11 Software Applied part according to IEC 60601 1 Use of Equipment after Transport and Storage ...

Page 26: ...aker 8 Mastoid electrode 9 Connection cable 10 MB 11 box 11 USB cable 12 Power Signal quality indicator 13 Cradle MB 11 Classic Hardware and System Assembly The MB 11 Classic unit consists of a USB box connected with the MB 11 Classic preamplifier by a cable The insert earphones and electrode leads plug into jacks in the preamplifier see Figure 11 The red plug of the insert earphone cable plugs in...

Page 27: ...onnection To perform measurements with the MB 11 device establishing a PC connection via USB is required If the MB 11 is used with office equipment that is not a medical device itself see section 4 4 1 PC connection 1 make sure to establish the PC connection in one of the following ways see section 4 4 1 PC Connection 2 3 or 4 Make sure you use only office equipment with the device that is a medic...

Page 28: ...B RAM or more 4 GB recommended Hard drive with minimum 10 GB free space Solid State Drive SSD recommended Minimum display resolution 1280 x 1024 or higher recommended DirectX 9 0C compatible graphics Intel NVIDIA recommended One USB port for every connected device version 1 1 2 0 or 3 0 Operating system compatibility The MB 11 software is compatible with the following operating systems Windows 10 ...

Page 29: ... to change the USB hub output Installation of MB 11 Software 4 4 4 1 Starting the Installation Process NOTE Make sure that the device is not connected with your computer while installing Note that you need administration rights for software installation Close all open or running programs Insert the Setup CD into the CD driver or plug the USB drive delivered with the device The InstallShield Wizard...

Page 30: ... Press Browse to choose another Destination Location and or press Next to proceed Figure 16 Press Back if a review or change of the settings is wanted Press Next to proceed Figure 17 Figure 16 Figure 17 The Device Driver Installation Wizard starts automatically Press Next to proceed Figure 18 Setup of the Device Driver is complete Press Finish to complete the installation Figure 19 Figure 18 Figur...

Page 31: ...er 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 the note above about using USB ports After a few seconds the system will show a message about a newly found USB device MAICO MB 11 4 4 4 3 Computer Settings for Optimal Performance To get the best possible power for the MB 11 BERAphone Classic it migh...

Page 32: ...he Device Manager item from the matches list Expand the Universal Serial Bus Controllers list to view the entire list Right click on each item in the list and select the Power Management tab Disable the checkbox Allow the computer to turn off the device to save power Select OK Repeat this for each item in the USB controllers list that has a Power Management tab ...

Page 33: ... the list and select the Power Management tab Disable the checkbox Allow the computer to turn off the device to save power Select OK Repeat this for each item in the Human Interface Device list that has a Power Management tab SCREEN SAVER In the Windows Search field type in Change screen saver and Enter Select the Change screen saver item from the matches list ...

Page 34: ... Power and sleep and Enter Select the Power sleep settings item from the matches list Set the values as follows Screen Set On battery power turn off after to 10 minutes Set When plugged in turn off after to 15 minutes Sleep Set On battery power PC goes to sleep after to Never Set When plugged in PC goes to sleep after to Never Select Additional power settings ...

Page 35: ...item Expand the Turn off hard disk after item Set On battery Minutes to Never Set Plugged in to Never Select OK button Expand the Sleep item Expand the sub items Set the values as follows Sleep after On battery Plugged in Never Allow hybrid sleep On battery Plugged in Off Hibernate after On battery Plugged in Never Allow wake timers On battery Plugged in Disable Select OK button ...

Page 36: ... Set the values as follows Minimum processor stated On battery 5 Plugged in 100 System cooling policy On battery Plugged in Active Maximum processor state On battery 100 Plugged in 100 Select OK button Expand the Display item Expand the sub items Set the values as follows Turn off display after On battery 15 Minutes Plugged in Never Display brightness On battery 100 Plugged in 100 Dimmed display b...

Page 37: ...Plugged in Off Low battery action On battery Do nothing Plugged in Do nothing Reserve battery level On battery 7 Plugged in 7 Select OK button Expand the Wireless Adapter Settings item Expand the sub items Set the values as follows PowerSavingMode Onbattery MaximumPerformance Pluggedin MaximumPerformance Select OK button Expand the Power buttons and lid item Expand the sub items Set the values as ...

Page 38: ...olders and Enter Select the Show hidden files and folders item from the matches list Set the View tab Select the circle in front of the Show hidden files folders and drives item to enable it Disable the checkbox in front of Hide extensions for known file types Select OK DISPLAY SETTINGS In the Windows Search field type in Change display settings and Enter Select the Change display settings item fr...

Page 39: ...Scale and layout Changed the size of text apps and other items Default Recommended Resolution Default Recommended Orientation Landscape Storage When the MB 11 is not in use store it in a location where it will be safe from damage to sensitive components such as the acoustic transducers and cables Store according to the recommended temperature conditions described in section 6 ...

Page 40: ...vice is connected to the USB port of your computer Start the MB 11 software by clicking the icon MB 11 USB Version on the desktop or direct from the program menu The program launches with the start screen see section 5 1 3 Connection to MB 11 Device The connected MB 11 device are always detected automatically After program start the message Scanning devices is displayed The connection is establish...

Page 41: ...try 12 Connected device type and SN 6 Tracking to entertrackingdata HiTrackTM 13 Quit to close the software 7 Select or toggle ear to test 14 Screener to select screener 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 If you use a touch screen you can run the program by t...

Page 42: ...D Alt D Display Today s list W Alt W Ctrl M Show Measurements R Alt R Right Ear L Alt L Left Ear E Alt E Change Ear M Alt M Measure Ctrl U USB Pop up window with the connected MB 11 devices Measurement Screen M Alt M Start Measurement T Alt T Stop Measurement P Alt P Pause Measurement C Alt C Continue Measurement O Alt O Other Ear Table 7 MB 11 Function Keys FUNCTION KEYS DESCRIPTION F2 Add to Tod...

Page 43: ...ient Click on the button Search to show a list of all stored patients in the Load from Database dialog see Section 5 6 2 Select a patient by double clicking on the name with the mouse or highlight the desired name and select the OK button Database filters are available in the Load from Database dialog to find patients more easily Enter a Pat ID or Last Name to filter the list by your entry Select ...

Page 44: ... low level stimulus delivered by the hearing screening system is overwhelmed by the background noise Acoustic noise can also awaken the baby causing less than optimal recording conditions and artifacts that prolong the test time Acoustic noise can lead to a REFER result even for a baby with normal hearing What can the screener do to reduce acoustic noise Find a location for the screening that is a...

Page 45: ... electrode impedance To achieve low electrode impedance electrode gel must be massaged into to the skin in the areas where the electrodes will make contact You can also prepare the skin with an alcohol pad or with a skin preparation product such as Nuprep Figure 22 IMPORTANT NOTE If any lotion has been applied to the baby s skin in the area of the electrodes then this should be removed with soap a...

Page 46: ... BERAphone on the baby s head Figure 23 First position the mastoid electrode below the earlobe If the baby moves follow the head movements with the BERAphone When the baby has stopped moving lower the other two electrodes into place making sure to achieve good contact with the prepared skin sites Figure 23 When you start the test the impedance test will show you if the electrodes are making good c...

Page 47: ...aby s ear canal The sections below offer the following information see Table 8 Table 8 Overview Preparing the Patient for Testing with EarCupsTM and eartips Section Use with Information 5 2 3 2 EarCupsTM and eartips Placing electrodes for ABR testing 5 2 3 3 EarCupsTM Placing the EarCupsTM on the patient 5 2 3 4 eartips Placing the eartips on the patient 5 2 3 2 Placing electrodes for ABR testing ...

Page 48: ... electrodes and any other conductive parts Figure 24 Connect the white black and yellow pinch clip electrode lead wires to a snap electrode Figure 24 Figure 25 Figure 26 Peel the electrodes from the backing card and place them on the electrode positions following this color scheme A graphic near the electrode jacks on the preamplifier illustrates proper placement for the nape montage as a reminder...

Page 49: ...ng card Place it around the baby s left ear with the adapter and tubing pointing toward the top of the head Press around the entire circumference of the EarCupsTM to ensure adhesion to the baby s skin Place the insert earphone transducer boxes above or to the side of the baby s head 5 2 3 4 Placing Eartips on the Patient Eartips Only Choose the proper size of eartips based on your inspection of th...

Page 50: ...er boxes above or to the side of the baby s head IMPORTANT NOTE The calibration value for the insert earphone is saved in the device Calibration values for inserts with eartips are different from calibration values for inserts used with EarCupsTM Never modify an insert earphone by replacing the original tubes and adapters with the other adapter type This will result in incorrect stimulus levels ca...

Page 51: ...e easily performed by properly trained personnel Additional information and results are available at any time for the doctor or specialist see section 5 1 6 PASS As soon as the indication mark reaches the green area this indicates that the Pass criterion has been met and the result is PASS REFER If no response is detected the test result is REFER ABORT If the test is aborted Stop Measurement is pr...

Page 52: ...Figure 33 Prepare the baby as described in section 5 2 When the baby is quiet start the test by clicking on the Start Measurement button Before starting the measurement an automatic impedance test is performed Figure 33 The measurement screen allows the operation with function buttons and a check box See Table 10 for more information ...

Page 53: ...nd returns to the start screen EEG If EEG is enabled check box the EEG signal is displayed during measurements otherwise signal quality bar indicators display Impedance Test The impedance is the resistance between the measuring electrodes Vertex Mastoid and the ground electrode This impedance is influenced by the resistance of the electrodes and more important the resistance of the skin Ideally th...

Page 54: ... impedance remains poor then use of a more abrasive skin preparation product such as Nuprep or an electrode skin prep pad may be needed Poor impedance can occur if lotion has been applied to the baby s skin The impedance test is passed when all three electrodes show green or yellow for seven seconds After passing the impedance test the measurement starts and the impedance indicator lights change i...

Page 55: ...f 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 Advanced Display Mode EEG Display The advanced display mode can be entered by clicking on the box EEG on the left of the test screen The EEG view at the top of the screen allows you to monitor the ongoing real ...

Page 56: ...st was passed successfully The result PASS is shown in the green area see Figure 39 Figure 39 5 5 5 2 Test Result REFER If the pass criterion is not reached after a specified time the result REFER displays in the lower right corner Figure 40 If the setting Allow reduced test time is enabled a REFER will be recorded at 120 seconds in case the progress line has never reached 60 toward the pass crite...

Page 57: ...button The test will be saved as an aborted test in the database If tracking is enabled a pop up window with reasons appears see Figure 41 Figure 41 Figure 42 A message box is shown to select the stop reason and add a note if wanted Figure 42 After confirming a reason the result ABORT with the reason is shown in the green area see Figure 43 Figure 43 ...

Page 58: ...e 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 For details on data filter options when searching for stored patient data see Figure 44 and Table 11 Print Select this menu item to print the measurement of the selected patient The printout format depends on which Print Mode is enabled...

Page 59: ...determination Test Result Use of the drop down allows you to filter the database for screening test outcomes PASS REFER ABORT Not Measured This filter will limit the names of the babies displayed in the list to those that have a test in the database that matches the displayed outcome This filter does not filter for the last or best test result In other words a baby that ultimately passed a screeni...

Page 60: ...If additional fields are completed using the Hi Track tracking feature these fields are not exported through this function In a spreadsheet this file should be viewed as a comma delimited file structure Tracking Export The Tracking Export controls allow you to set a data range using calendar controls and export patients and tests performed in this date range to a file that is formatted according t...

Page 61: ...lecting the baby to be tested select the ear to be tested right R or left L and start the test by clicking on the button Measure For test procedure see section 5 5 Names added to the Today s list will be erased automatically 48 hours after entry or as soon as a test is initiated However even if a test is not performed the name will remain in the database Printing You can print out the measurement ...

Page 62: ...ch you wish to print and confirm with OK NOTE For Selected each monaural test is printed on a separate label The following information will be printed out on the label Figure 47 Figure 47 NOTE For further information about printing labels see the operation manual of the label printer List Printout The list printout includes a header with address information and logo a section with patient informat...

Page 63: ...t The detailed printout includes a header with address information and logo a section with patient information followed by the tests For each measurement is diagram is printed on the left showing the progress line of the test and the available measurement information on the right side Result Test date and time Duration s Artifacts Impedance kΩ Test mode Stimulus Stimulus level dB nHL Screener Faci...

Page 64: ...esults Figure 50 By confirming with OK the selected results will be printed in the format according to the setting Print Mode Figure 50 Export Tests Tracking 5 6 5 1 General 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 HiT...

Page 65: ...in the Auto Tracking Settings area of the Options screen the button Tracking appears on the start screen Figure 51 Figure 51 Click on the Tracking button to open the input window Figure 49 Patient data are automatically copied from the main screen Figure 52 Figure 52 Fill out the form with the information your program tracks ...

Page 66: ...ed Nevertheless it is possible to press Cancel to bypass the screen Figure 53 5 6 5 4 Export Functions of the MB 11 Database Tracking disabled The MB 11 software allows the export of patient and test data from the database The export file will 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 Sear...

Page 67: ...s the one that OZ or HiTrackTM will be looking for to merge the data Settings To configure the MB 11 software select Options from the Settings menu The Options dialog Figure 25 is opened This menu item is only selectable from the Start screen Table 13 gives an explanation of the different selections in the Settings menu Table 13 Settings Menu MENU ITEM INFORMATION Settings Save Test Settings Saves...

Page 68: ...planation below Figure 56 Language Choose one of the following program languages English default 中文 Nederlands Vlaanderen English Australian Français Deutsch Magyar Italiano 日本語 Порусский Español and Türkçe Database Path The default path for saving the MB 11 database is displayed in this field The MB 11 database file includes all patient and test information as well as screener physician screening...

Page 69: ... most recent ABORTED test will print Latest In this mode the most recent result for both ears will print out by default with no regard to the result Selected In this mode the Printing measurements dialog is displayed so the user can select Individual tests for printing Printer Settings This control opens a standard Windows printer screen from within the MB 11 software For efficiency it is recommen...

Page 70: ...ly the same format as they are entered in the HiTrackTM application or there will be merge errors upon importing the tracking file into HiTrackTM Birth Hospital this is a HiTrackTM field The list of hospitals is accessible for selection when HiTrackTM is enabled and when the user enters the Tracking screen by selecting the Tracking control on the main screen It is referred to as the Hospital code ...

Page 71: ...erformed through a manual process by exporting based on a manually entered date range entered in the Search screen 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 ...

Page 72: ...ables 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 Automati cally close test distortion message Enabling of this control causes a pop up message regarding test distortion to disappear automatically When disabled the user must manually close this message that occurs immediately after an impedance te...

Page 73: ...y the right ear or left ear can be selected and only a monaural test can be performed Patient ID Settings The Patient ID Settings area allows the user to set preferences regarding the handling of the patient ID Figure 62 Figure 62 Select one of the following options Disable disables the field for the patient ID Control is not available when Tracking is enabled Disabling the Pat ID field allows you...

Page 74: ...le or disable this option Both passwords for enabling or disabling this feature and for changing settings of the MB 11 Software are only provided to an authorized person on request Figure 63 Figure 63 IMPORTANT NOTE If the option Password Protected Settings is enabled a password must be entered to make changes to any of the settings The password entry screen displays after selecting the OK button ...

Page 75: ...IIa of the EU medical directive 93 42 EEC General Information About Specifications The performance and specifications of the device can only be guaranteed if it is subjected to technical maintenance at least once per year MAICO Diagnostics puts diagrams and service manuals at the disposal of authorized service companies STANDARDS Medical CE mark Yes Device Safety IEC 60601 1 2005 A1 2012 ANSI AAMI...

Page 76: ... in x 3 7 in x 1 2 in Weight 142 g 0 3 lb Language Settings English English Australian German Spanish French Italian Dutch Belgium Turkish Chinese Japanese Hungarian Magyar Russian Data Interfaces PC connection USB Connectors USB USB B to PC Power Supply USB Approximately 310 mA ABR Stimulus Type CE CHIRP 135 Hz to 7 5 kHz Level 35 dB nHL Stimulus rate 88 s left ear 92 5 s right ear Transducers IP...

Page 77: ...37 cm 14 5 in Tube length 25 cm 9 8 in Tube colors Red right ear and blue left ear Weight incl cables 53 g 1 87 oz BERAPHONE Preamplifier Channels One Gain 69 6 dB Frequency response 35 Hz to 4 3 kHz Noise 25 nV Hz CMR Ratio 120 dB at 80 Hz Input impedance 1100 MΩ 32 pF 98 MΩ at 50 Hz Power supply Isolated from USB box Speaker Integrated Dynamic 8 Ω Electrodes 3pcs with gel protectors Stainless st...

Page 78: ...AMPLIFIER Channels One Connectors 3 electrode lead wires black yellow white Transducer IP30 left and right Gain 69 8 dB Frequency response 35 Hz to 3 9 kHz Noise 25 nV Hz CMR Ratio 115 dB at 80 Hz Input impedance 1100 MΩ 32pF 98 MΩ at 50 Hz Power supply Isolated from main unit Weight 100 g 3 5 oz Dimensions 100 mm x 100 mm x 22 mm 3 9 in x 3 9 in x 0 9 in Cable length 187 cm 73 6 in Electrode lead...

Page 79: ...B 11 BERAphone Classic 8100496 Rev 6 77 23 10 2019 Pin assignment USB A USB B 1 5 VDC 2 Data 3 Data 4 Ground 1 5 VDC 2 Data 3 Data 4 Ground Connecting plugs Connection Specification USB socket USB B max 400 mA Figure 65 ...

Page 80: ...andard EN 60645 3 Correction values for EarCupTM calibration values are defined as MAICO standard values BERAphone with coupler 60318 3 TRANSDUCER CE CHIRP pe RETSPL dB re 20 µPa BERAphone 32 5 The calibration values for the BERAphone are according to the PTB Report from 2008 05 19 The values are equal to the click stimulus calibration values for the MB 11 BERAphone regarding the standard ISO 389 ...

Page 81: ...armonics of the stimulus repetition rate are extracted from the spectrum of the EEG signal All the amplitude and phase values of harmonics of all previous and the current epochs are included in the calculation of a test value After every calculation of the test value it is compared with a critical test value to determine presence or absence of a response Since the critical test value varies with e...

Page 82: ...transmitter m 150 kHz to 80 MHz d 1 17 𝑃 80 MHz to 800 MHz d 1 17 𝑃 800 MHz to 2 7 GHz d 2 23 𝑃 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 70 3 70 7 37 100 11 70 11 70 23 30 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P i...

Page 83: ...te survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field stren...

Page 84: ...N On the preamp Colour marked sockets with head symbol Analog input for Physio logical signals Electrical Safety EMC and Associated Standards IEC 60601 1 2005 A1 2012 ANSI AAMI ES60601 1 2005 A1 2 Medical Electrical Equipment Part 1 General Requirements for Safety CAN CSA C22 2 No 60601 1 2014 Medical electrical equipment Part 1 General requirements for basic safety and essential performance IEC E...

Page 85: ...ce MAICO Diagnostics 10393 West 70th Street Eden Prairie MN 55344 United States Tel 1 888 941 4201 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 sales maico biz Internet www maico biz ...

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