Maico MB 11 Classic User manual

Operation Manual
MB 11 Classic

Operation Manual MB 11 Classic
8100498-4_OM_MB11_Classic_3.18_EN_16a.docx
1
01/16
Table of Contents Page
1 Introduction 3
2 Important safety instructions 4
3 Description 6
3.1 Auditory Brainstem Response (ABR) audiometry 6
3.2 The MB 11 Classic 6
3.3 Automatic Screening with the "Fast Steady State Algorithm” 6
4 Installation and Settings 8
4.1 USB Specifications 8
4.2 Installation of MB 11 Software 8
4.3 Minimum computer specifications 8
4.3.1 Power supply 9
4.4 Operating system settings 9
4.4.1 Deactivate “save power” (USB hubs) 9
4.4.2 Change Power Options 13
4.4.3 Change visual effects 17
4.4.4 Change Display 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 “Settings” 24
5.4.3 Menu “About” 27
5.5 Operation with mouse and keyboard or touch-screen 28
5.6 Registry of new patient data 30
5.7 Loading stored patient data 31
5.8 Working with a “Today’s list” 32
6 Automatic testing in the automated ABR screening mode 33
6.1 Preparing the Patient for measurements 33
6.2 Placement of the Electrodes 34
6.3 Placement of Insert earphones 34
6.3.1 Insert earphone tubing and adapters 34
6.3.2 In-the-ear Eartips 35
6.3.2.1 Selecting a disposable ear tip 35
6.3.2.3 Placement of eartips for infants 35
6.3.2.4 Placement of eartips for adults 35
6.3.3 Use of adhesive EarCup couplers 36

Operation Manual MB 11 Classic
8100498-4_OM_MB11_Classic_3.18_EN_16a.docx
2
01/16
6.3.4 Removal of disposables 36
6.4 Performing the screening test 37
6.4.1 Impedance Test 38
6.4.2 The signal quality control 39
6.4.3 EEG-Display 40
6.4.4 Test result “Pass” 42
6.4.5 Test result "Refer" 43
6.5 Binaural Screening 44
6.5.1 Preparing for a Binaural Screening 45
6.5.2 Binaural Screening Result 45
7 Tracking 47
7.1 Tracking Settings 47
7.2 Input of Tracking data 48
7.3 Advanced Tracking data 49
7.4 The export functions of the MB 11 database (no tracking 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 with the Time Step Stimulus 54
8.1.3 Advanced display Time Step Stimulus Test 56
8.2 Testing with Standard-ABR 57
57
9 Care and maintenance of the instrument 58
10 Trouble shooting 59
10.1 Instrument does not turn on 59
10.2 Poor impedance at one or more electrode sites. 59
10.3 High artifact (poor signal quality) during the screening 59
10.4 Screening result is not progressing 59
11 Technical Data 61
12 Scientific Background Information 64
12.1 CE-Chirp Stimulus™ 64
13 Warranty, Maintenance and After-Sales Service 68
14 Safety Regulations 69

Operation Manual MB 11 Classic
8100498-4_OM_MB11_Classic_3.18_EN_16a.docx
3
01/16
1 Introduction
Thank you for purchasing a quality product from the MAICO family. This
automatic ABR-test system MAICO MB 11 Classic (Standard) 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 functions will be simple and
inexpensive. That means that you have invested in a device that will adjust
to your future needs.
If you have problems or have ideas for further improvements, please get in
touch with us. Simply call.
Your MAICO-team

Operation Manual MB 11 Classic
8100498-4_OM_MB11_Classic_3.18_EN_16a.docx
4
01/16
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.
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 is not allowed in close proximity to the MB 11
Classic.
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 601-1
safety against electrical hazard. This is only guaranteed, when
the connected notebook computer is powered by batteries or
the computers power supply accords to IEC 601-1 or IEC 950-1
safety regulations and an isolation transformer meeting
requirements of IEC 61558-2-1 or 60601-1 is used. The
complete system must meet the leakage current requirements of
IEC 60601-1-1. This complete system consisting of the MB11
Classic, computer and isolation transformer, 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 from
Notebook or computer. Alternatively work in battery mode, use
a Medical-PC or a special mains adapter according IEC 601-1.

Operation Manual MB 11 Classic
8100498-4_OM_MB11_Classic_3.18_EN_16a.docx
5
01/16
Precautions
READ THE ENTIRE MANUAL BEFORE ATTEMPTING TO USE THIS
UNIT. Use this device only as described in this manual.
Before measurement make sure, that the device works properly.
Do not drop or cause undue impact to this device. If the
instrument is dropped or damaged, return it to the manufacturer
for repair and/or calibration. Do not use the instrument if any
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 59ºF (15ºC)
or above 95ºF (35ºC), 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.
Disclaimer
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.

Operation Manual MB 11 Classic
8100498-4_OM_MB11_Classic_3.18_EN_16a.docx
6
01/16
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 MB11 Classic uses standard disposable
electrodes to record an auditory brainstem
response (ABR). Insert earphones are used to
deliver the acoustic stimulus.
The MB11 performs 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 presented at a high repetition rate
(93/second). At this rate a so-called "Steady-State Response" (SSR) occurs.
The objective statistical determination of the presence of the SSR is
performed after the EEG is processed to determine its frequency content.
The SSR is described in the frequency domain by a few spectral lines
(harmonics), mathematically related to the stimulus rate of 93 Hz. The
statistical test uses the phase and amplitude information of the harmonics
below 1200 Hz. Frequencies in the processed EEG that are not related to the
stimulus 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.
Figure 1
Testing with MB11 Classic

Operation Manual MB 11 Classic
8100498-4_OM_MB11_Classic_3.18_EN_16a.docx
7
01/16
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 not
achieved after 180 seconds of artifact-free
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.
Neither the algorithm nor critical test values are adjustable by the user.
Figure 2
MB 11 - program test result - “PASS”

Operation Manual MB 11 Classic
8100498-4_OM_MB11_Classic_3.18_EN_16a.docx
8
01/16
4 Installation and Settings
4.1 USB Specifications
The MB11 is a high-powered device that requires a USB port with
500 mA dc current over the VUSB - 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 MB11 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 MB11 is only supported by MS Windows 2000 SP4 and
above and MS Windows XP SP1and above*, Windows 7 Professional 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 USB driver files. 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 and Windows 8 Pro.

Operation Manual MB 11 Classic
8100498-4_OM_MB11_Classic_3.18_EN_16a.docx
9
01/16
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 quality. The buzzing noise also affects the audio
output of computers and produces a masking noise signal. This will falsify
the results of the measurements.
PC battery Mode:
To assure the most undisturbed (humming noise free) measurement and
masking noise free stimuli, it is necessary to disconnect all external 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 for the MB11 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
confirm

Operation Manual MB 11 Classic
8100498-4_OM_MB11_Classic_3.18_EN_16a.docx
10
01/16
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 if preselected. (Don’t allow
the computer to turn off this device to save power.)

Operation Manual MB 11 Classic
8100498-4_OM_MB11_Classic_3.18_EN_16a.docx
11
01/16

Operation Manual MB 11 Classic
8100498-4_OM_MB11_Classic_3.18_EN_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 to turn off this device to save power).
Deactivate both
options

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

Operation Manual MB 11 Classic
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: never
System on standby: never

Operation Manual MB 11 Classic
8100498-4_OM_MB11_Classic_3.18_EN_16a.docx
15
01/16
Select Hibernate within the menu bar and 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 off monitor never after 30min
Turn off hard disk never after 30min
System standby never never
System hibernates never never

Operation Manual MB 11 Classic
8100498-4_OM_MB11_Classic_3.18_EN_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 the lid of my portable computer” Do nothing as shown in the
picture.

Operation Manual 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 and confirm

Operation Manual MB 11 Classic
8100498-4_OM_MB11_Classic_3.18_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 background settings to none.
Select Screen Saver setting to none.