Download MA33 Operating Manual

MA33 Operating Manual
Maico Diagnosticsi7625 Golden Triangle DriveiEden Prairie, MN 55344iToll Free 888.941.4201
Maico Diagnostic GmbHiSalzufer 13/14i10587 Berlin, GermanyiTelephone ++030 70 71 46 50
MA33 Operating Manual
Table of Contents
Page
1. Introduction ................................................................................................ 1
1.1 PC-System Requirement ............................................................................... 1
2. Description .................................................................................................. 2
2.1 Important Safety Note ................................................................................. 2
2.2 Unpacking and Checking the MA33 ............................................................ 3
2.3 Standard Accessories ................................................................................... 3
2.4 Connecting the accessories .......................................................................... 4
3. Software Installation .................................................................................. 5
3.1 MA33 Software installation ......................................................................... 5
4. Manual Device Driver Installation ............................................................. 7
5. Working with the MA33 ............................................................................ 9
5.1 Operation with Mouse and Keyboard......................................................... 10
5.1.1 Different Keyboard Function Keys........................................................ 10
5.2 Tone Setting .............................................................................................. 11
5.2.1 Display ................................................................................................ 12
5.2.2 Masking .............................................................................................. 12
5.2.3 Operation ........................................................................................... 12
5.2.4 Function Keys ...................................................................................... 12
5.2.5 Frequency ........................................................................................... 13
5.2.6 Settings............................................................................................... 13
5.3 Speech Settings ......................................................................................... 14
5.3.1 View ................................................................................................... 16
5.3.2 Counter .............................................................................................. 16
5.3.3 Operation ........................................................................................... 16
5.3.4 Information ......................................................................................... 16
5.3.5 Functionality ....................................................................................... 16
5.3.6 Settings............................................................................................... 17
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MA33 Operating Manual
Table of Contents (Cont.)
Page
6. Testing Process.......................................................................................... 17
6.1 Preparing for Measurement ....................................................................... 18
6.2 Air Conduction Threshold Measurement .................................................... 19
6.3 Air Conduction Screening .......................................................................... 20
6.4 Bone Conduction Threshold ....................................................................... 21
6.5 SISI-Test ..................................................................................................... 22
6.5.1 Preparing for the Tests ........................................................................ 22
6.5.2 Training of the Patient ......................................................................... 23
6.5.3 Execution of the SISI-Tests ................................................................... 23
6.6 Speech Testing .......................................................................................... 25
6.6.1 Conducting a Speech Test ................................................................... 25
7.
QuickSIN
TM
............................................................................................. 27
TM
7.1
7.2
7.3
7.4
7.5
QuickSIN Methodology...................................................................... 27
Calibration ............................................................................................ 27
Presentation Level ................................................................................. 27
Test Instructions .................................................................................... 27
Scoring ................................................................................................. 28
7.6
7.7
7.8
7.9
7.10
Averaging Multiple QuickSIN Lists...................................................... 28
What is SNR Loss? ................................................................................. 28
Where does the number 25.5 come from? ............................................ 29
Reliability .............................................................................................. 30
Comparison Between Two Conditions................................................... 31
TM
8 Ownership, Warranty and Disclaimer ..................................................... 32
9 Safety Regulations.................................................................................... 35
10 Technical Data ......................................................................................... 36
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MA33 Operating Manual
1. Introduction
Thank you very much for choosing a quality product from the MAICO family. The MA33 is
designed and manufactured to meet all quality and safety requirements, and has been
certified with the CE-symbol according to Medical Directive.
Particular attention has been taken during the designing of the MA33 to ensure its userfriendliness, meaning that its operation is simple, easy to learn and to understand. As all the
functions are software-controlled, upgrading the software and/or adding additional functions
later will be simple and cost-effective. By purchasing the MAICO MA33, you have made a
decision towards long-term investment.
This operating manual aims to make learning and understanding the different functions of the
MAICO MA33 as quick and as easy as possible. Should you encounter any problems or have
ideas for further improvements, we are only a phone call away. Please contact us.
Your MAICO-Team 888-941-4201
ATTENTION
Though much attention is paid to the accuracy of this manual, some recommendations and
instructions given may differ depending on your application. It is recommended to contact
the MAICO prior to installation- if your use of the MA33 will be in an atypical setting. The use
and application of the MA33 is directly connected to the Microsoft Windows Operating
system as well as your computer’s hardware components, including your soundcard. These
components may directly affect the operation of your MA33 and MAICO makes no claims of
compatibility with the MA33 and any other software/hardware not specifically referenced in
this documentation.
1.1 PC-System Specification.
Processer (CPU):
System RAM:
Hard Disk Space:
Optical Drive:
Screen Resolution:
Interface Port:
Operating System:
Minimum
Intel Pentium III processor or comparable
at 1.4 GHz
512 MB
2 GB free space
CD ROM Drive
1024 x 768
USB
Windows XP Pro SP3
*Please note we do not support home or
basic editions*
1
Recommended
Intel Pentium 4 processor or
comparable at 2.4 MHz
1024 MB
2 GB free space
CD-RW drive
1024 x 768
USB 2.0
Windows XP Pro SP3, Windows 7
Professional (32/64-bit)
*Please note we do not support
home or basic editions*
MA33 Operating Manual
2. Description
•
The MA33 is a small and light weight PC based audiometer that provides air, bone, and speech
testing using your PC’s existing soundcard
2.1 Important Safety Note
The MA33 should always be operated in a quiet room with minimal magnetic influence, so
the examinations are not disturbed by external noise.
Electro-medical instruments that emit strong electromagnetic fields (e.g. microwaves,
radiotherapy devices) can affect the functions of the MA33.
Therefore the operation of these instruments in close proximity to the MA33 should at all time
be avoided.
The examination room should have a normal temperature of 15˚C/ 59˚F to 35˚C/ 95˚F. If the
instrument has been cooled down during transportation, please wait for it to warm up to
room temperature before operation.
MAICO MA33 is specified according to EN 60 601-1.
Protection against electrical hazard is guaranteed only when the instrument is connected
to a safety ground. Please note that the instrument should always be connected to a
battery-operated or mains-operated notebook computer that is in compliance with EN 60
601-1 or EN 60 950-1 during operation. In case of a damaged main cable, connector or
wall socket, please do not use the instrument under any circumstance.
Attention
PLEASE READ THE ENTIRE MANUAL CAREFULLY BEFORE OPERATING THIS
INSTRUMENT.
Please only use this instrument as described by the manual.
Please familiarize yourself with the instrument and its operation before using.
Should defects or damages be suspected, please do not, under any circumstances,
use or attempt to fix the instrument yourself.
Calibration of the instrument: The audiometer and the headphones (both air and
bone conduction) complement each other and share the same serial number (i.e.
7663252). Therefore the instrument shall not be used with another headphone
prior to recalibration. Recalibration should also apply when a defected headphone
is replaced.
Un-calibrated instruments may lead to faulty measurement and sometimes even
damage the hearing of the examinee.
Take note that all the accessories are properly connected. PC shall only be turned
on after the MA33 has been connected.
Parts that come direct into patient contact (i.e. headphone cushion) should be
disinfected using commercial disinfectant after each use to avoid person-to-person
cross contamination of communicable diseases. In accordance to the Electronic
Equipment Act for disposal of electronic equipment, the customer is obliged to
dispose of the used consumables according to appropriate regulation at own cost.
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MA33 Operating Manual
2.2 Unpacking and Checking the MA33
Checking for Packaging and Content Damage
Thoroughly inspect the exterior of the shipping for sign of damage or tempering. Should any
damage be noted, please notify the carrier and your dealer immediately. If the content box is
damaged during transportation, the instrument should be checked for any electrical or
mechanical defects. Should any defects be identified, please contact the responsible dealer.
Keep all original packaging to facilitate any insurance claims against the damages.
PLEASE KEEP ALL ORIGINAL PACKAGING FOR FUTURE USE!
The MA33 is packaged in a specially-designed box. Please keep the box as it will be useful for
sending the instrument for it is recommended annual calibration.
Please contact your dealer for annual calibration and service.
2.3 Standard Accessories
MA33 PC-Screening Audiometer
•
•
•
•
•
•
•
•
•
EAR 3A Insert Earphones
B71 Bone Conduction Headset
Patient response switch
Microphone
MA33 User software
Maico Database
USB Connection Cable
Operating Manual
Software Installation Manual
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MA33 Operating Manual
2.4 Connecting the accessories
All the connection jacks can be found on the rear side of the MA33. All the cables and
accessories should be connected before the USB cable is plugged in.
NOT USED
Figure 1 Rear of MA33
A = Bone Conduction Headphone
B = Right Air Conduction Headphone (Red Plug)
C = Left Air Conduction Headphone (Blue Plug)
D = Patient Response Switch
E = USB Connector
DO NOT CONNECT THE MICROPHONE TO ‘EL OUT!’ This connection jack is not used!
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MA33 Operating Manual
3. Software Installation
Do NOT connect the MA33 to the PC until instructed by installation wizard!
The MAICO-Database should be installed prior to the software installation. After the
installation a MAICO database icon can be found on the desktop that links directly to the
patient database.
3.1 MA33 Software installation
All programs should be closed before inserting the MAICO MA33 installation CD into the CDRom.
In case the installation does not start automatically, please go to Window Explorer and click on
“Setup.exe” from the CD.
The User software should be installed in this directory: C:\Program Files\MAICO
Note: Your path may be C:\Program Files (x86)\MAICO on a 64-bit Operating System.
Figure 3
Figure 2
Figure 4
Figure 5
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MA33 Operating Manual
Figure 7
Figure 6
Figure 8
*Note: Be sure to click INSTALL and check “Always trust software from “Maico Diagnostics
GmbH”
Figure 9
NOTE: Connect the MA33 to the computer using the USB Cable
You may see several prompts from Windows indicating a new device has been found.
Disregard these messages.
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MA33 Operating Manual
4. Manual Device Driver Installation
If for any reason the driver does not get loaded during the software installation you may
manually load the driver.
Click Start or Windows logo (in lower left corner) and type ‘device manager’ in the search box
Under “Other Devices” right click on ESCAPE and select UPDATE DRIVER
Figure 11
Figure 10
Click “Browse my computer for driver software. Click “Let me pick from a list….”
Figure 13
Figure 12
Click “Show All Devices” then click Next, Click “Have Disk”
Figure 14
Figure 15
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MA33 Operating Manual
Type “D:” in the text field. Windows will find the best driver for your system. Click “Maico
Note: “D” is the letter of your CD drive that contains The MA33 User Software
Figure 17
Figure 16
Click “Show All Devices” then click Next, Click “Have Disk” “MA33” and then NEXT
Figure 18
You are now ready to use the MA33!
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MA33 Operating Manual
5. Working with the MA33
Start the patient database and load the patient to be tested, and then start the MA33
software.
Figure 19 shows the starting screen of the program. There will be slight differences in settings
and functionality based on the different set-up menu items.
Figure 19 – Start Screen of MA33
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MA33 Operating Manual
5.1
Operation with Mouse and Keyboard
The MA33 can be easily operated with the mouse by simply pointing and clicking on required
button or input field on the screen.
Different combination of keys allows for quick operation. Hold down the <ALT> key together
with the underlined letter on the different function key to execute the said function.
Delete: Delete the previous measurement.
Load: Load a previously stored measurement. The loaded thresholds will be displayed in
different color.
Save: Save current measurement.
End: End the Program.
Remarks: Comments and additional remarks can be added here.
Connection Status: Indicates if the instrument is properly connected to the PC.
5.1.1 Different Keyboard Function Keys
F2
F3
F4
F5
F6
F8
F9
F12
TAB
Ctrl (right)
Ctrl (left)
Spacebar
Delete
Alt+L
Alt+S
Alt+X
Alt+U or ?
B
Alt+T
E
N
L
R
T
↑↓
Home
Page ↑↓
S
W
P
M
Switch between tone and speech screen
Switching between left and right
Masking right channel
Air Conduction
Bone Conduction
Pulse tone on/ off
Masking left channel
Interrupter / Presenter Mode
Switching between left/right ears
Presenter / Tone transducer right
Presenter / Tone transducer left
Presenter / Tone transducer for the active side
Delete last measurement
Load available measurement
Save measurement
End program
Mark unclear threshold with “?”
Binaural
Opens Setting menu
Edit
No response
Left ear
Right Ear
Talk-forward
Intensity adjustment for the test ear
Return to 1kHz
Intensity adjustment for the opposite ear (masked ear)
SISI test in tone screen/Start-Stop in speech screen
Warble tone
Pulse tone/ play-pause in speech screen
Turns masking noise on/off
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MA33 Operating Manual
5.2 Tone Setting
In the tone screen under the option “Setting“, different setting options are available
for display, masking, control, test functions, frequency and settings.
Figure 20 – Setting Options for MA33
The setting can be changed by clicking on the different setting options. Click “OK” to
apply the new setting.
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MA33 Operating Manual
5.2.1 Display
Combined Audio: Displays both ear measurement in one audiogram.
R < - - - > L: Switching between left or right ear display.
Degrees HL: Display degrees of hearing loss on the audiogram.
Edit: Edit the measured curves.
Speech Sounds: Display the “speech banana” on the audiogram.
5.2.2 Masking
Automatic: Different intensity of masking can be entered directly when “Automatic”
masking is activated.
Default masking for air conduction and bone conduction are -30 dB and +10 dB, respectively.
These levels can be changed by using the mouse to move the vertical arrow keys.
Manual: Enables masking level to be adjusted manually during testing.
Graphic: To view the masking setting graphically, click “Graphic“.
5.2.3 Operation
Mouse: Frequency and intensity level can be easily adjusted by pointing and right/left-clicking
the mouse on a specific place in the audiogram.
Audio-Keyboard: the function keys will be activated when an Audio-Keyboard (additional
accessories) is connected to the computer.
Interrupter: Switch to interrupter mode.
Presenter: Switch to presenter mode.
Store Value by Interrupt: Every time a tone is presented, a threshold will be plotted. Only
the last level presented will be stored.
5.2.4 Function Keys
Screening 20 dB: By clicking the button a window opens to offer screening test at different
decibel level. Moving the decibel bar increases or decreases the tone intensity to be used for
screening. Default is set at 20 dB.
Level Settings: The starting level can be changed from -10 dB to 50 dB with this function
key.
Level after Accept: The level by which the test level decreases after a threshold is saved can be
set. Choices are changes of 0 (no change) to -20 (decrease by 20 dB).
After changing ears: If “Keep level” is activated, the level will remain at the same value when
switching between right and left ears.
Up/down keys: Up/down arrow keys can be reversed for increasing/decreasing of the level.
Help: Currently not in use.
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MA33 Operating Manual
Info: Gives information about the audiometer including hardware/software version, serial
number and calibration due date. A reminder can also be set for the next calibration to be
scheduled.
5.2.5 Frequency
Block/ PTA- Frequencies: Certain frequencies can be blocked and hence will be skipped over
during audiometric testing (this does not apply when a mouse is used). Also, choose
frequencies to be used for Pure-tone average calculation.
Step by : After saving the data use the “Enter“ key to move the cursor one frequency at a
time.
Auto Settings: Choose when the audiometer should automatically return to 1kHz. When
wrapping is activated, instead of returning to 1 KHz at the end of the frequency range, the
cursor will return to the start of the frequency range, as if circulating the frequency range.
Safety Function: If turned on, this prevents immediate increase of level above 70dB when
changing frequency.
5.2.6 Settings
Permanent pulse: A pulsing tone will be the default if this feature is activated
Binaural: Selecting “individual” allows the level for each ear to be adjusted separately.
Selecting “simultaneous” allows both sides to be adjusted with only one attenuator.
Print: Offers different print settings such as Color Print (Standard Setting B/W), DIN A5
(Standard A4) and other print options should standard print not be preferred. In addition,
degrees of hearing loss and speech sounds can be added to the audiogram on the printout.
Clinic name and address details can be added under “Address“.
Evaluation: If “Evaluation” is selected, the software will not look to connect the hardware
device when the program is opened. This status is displayed in the lower right corner of the
screen. This starts the program faster and will automatically load the last measurement if
running within the Maico database. This feature can be used to quickly look up evaluations or
print results when testing is not being conducted.
Default Settings: Remove all changes and returns all to factory default settings.
OK: By clicking “OK“ the changes in Setting will be applied and the program returns to start
screen.
Ask for Examiner: Should more than one examiner use the program, each examiner can save
his/her customized settings for future use and reference.
Examiner: Several different settings can be customized and saved for different examiners
should more than one examiner be using the MA33 program.
Cancel: Confirm if the changes should be saved before returning to the start screen.
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MA33 Operating Manual
5.3 Speech Settings
In the tone screen under the option “Setting“, different setting options are available
for display, masking, control, test functions, frequency and settings.
Figure 21 – Speech settings screen
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MA33 Operating Manual
5.3.1 View
R < - - - > L: Switching between left or right ear display.
Edit: Edit the measured curves.
5.3.2 Counter
Relative: This setting scores word lists as a % correct according to how many words have
actually been presented.
Absolute: This setting scores word lists as a % correct of the entire number of words in the
selected list, regardless of how many of the words are actually presented to the patient.
5.3.3 Operation
Mouse: Frequency and intensity level can be easily adjusted by pointing and right/left-clicking
the mouse on a specific place in the audiogram.
Store value by interrupt: Every time a tone is presented, a threshold will be plotted. Only the
last level presented will be stored.
5.3.4 Information
Help: Currently not in use.
Info: Gives information about the audiometer including hardware/software version, serial
number and calibration due date. A reminder can also be set for the next calibration to be
scheduled.
5.3.5 Functionality
Switching Ear: If not activated (reset level, switch off noise), the level will return to the default
starting level and masking noise will be turned off when switching ears on the test screen. If
activated (keep level & noise), the settings will remain when switching between ears.
Microphone: Select Sound card, input, and adjust level of microphone.
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MA33 Operating Manual
5.3.6 Settings
Level Control: If activated, displays a warning if the presentation level is changed during a
speech test.
Binaural: Selecting “individual” allows the level for each ear to be adjusted separately.
Selecting “simultaneous” allows both sides to be adjusted with only one attenuator.
Print: Offers different print settings such as Color Print (Standard Setting B/W), DIN A5
(Standard 81/2” x 11”) and other print options should standard print not be preferred. In
addition, degrees of hearing loss and speech sounds can be added to the audiogram on the
printout.
Evaluation: If “Evaluation” is selected, the software will not look to connect the hardware
device when the program is opened. This status is displayed in the lower right corner of the
screen. This starts the program faster and will automatically load the last measurement if
running within the Maico database. This feature can be used to quickly look up evaluations or
print results when testing is not being conducted. If your MA33 is connected but not
presenting tone make sure the status in lower right hand corner shows connected and the
software is not set to “Evaluation.”
Default Settings: Remove all changes and returns all to factory default settings.
OK: By clicking “OK“ the changes in Setting will be applied and the program returns to start
screen.
Ask for Examiner: Should more than one examiner use the program, each examiner can save
his/her customized settings for future use and reference.
Examiner: Several different settings can be customized and saved for different examiners
should more than one examiner be using the MA33 program. The examiner with the check
mark near their name is currently selected.
Cancel: Confirm if the changes should be saved before returning to the start screen.
Language: Change language of software display. Choices are English, German, or Spanish.
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MA33 Operating Manual
6. Testing Process
Hearing Threshold
In tone audiometry, the sound intensity is usually measured in Decibel (dB) and the frequency
in Hertz (Hz). Decibels are used as an indication of the hearing threshold. A hearing threshold
of 0 dBHL is defined as “Normal Hearing” based on a large number of measured values. It is
also possible to have a hearing threshold of -10 dBHL , when the patient has exceptionally
good hearing.
Tone Audiometry
The Tone Audiometry is the most used method to determine hearing threshold. Generally the
test is executed with sinus tones in the frequency range of 125 – 8000Hz for adult, and 250 –
4000Hz for children. The lowest hearing threshold is determined when the patient can just
barely hear the tone. The test requires a high degree of concentration and cooperation of the
patient. Therefore it is sometimes difficult to determine the hearing threshold for young
children, as it is often difficult for children to understand the test procedure properly and hold
their attention for the entire test session.
Pulse Tone Measurement
Due to the above reason Pulse Tone Measurement often replaces the Sinus Tone
Measurement for hearing investigation in children. Changing to the pulsed tone may hold the
child’s attention for a bit longer during the test session.
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MA33 Operating Manual
6.1 Preparing for Measurement
Figure 22 – Start screen MA33
The start screen opens automatically when the MA33 program is started.
The left/right signals and the transducer tone can be selected by using the mouse.
Select the headphone. By default when the right channel of the headphone is “Tone“ the left
would be set to “Off“. The measurement begins with 1 KHz. The colored bars (red for right
and blue for left) at the bottom of the audiogram indicate the activated channel.
Explaining the Test Procedure: The patient will be presented with a series of soft tones
hence it is important to pay attention. As soon as a tone is heard, even very soft, the patient
should respond by pressing the Patient Response button. The test will begin first with the
right ear followed by the left.
Preparing the Patient: The patient should be seated at least 1 meter away from the
instrument. Particular attention should be paid to ensure no hair comes between the ears and
the headphone. Glasses should be removed before the test. The headphone should be
placed with correct positioning that the earphone is exactly over the ears, and that the red
earphone covers the right ear and the blue one on the left.
The test normally begins with the right ear.
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MA33 Operating Manual
6.2 Air Conduction Threshold Measurement
Figure 23 –MA33 Air Conduction Start Screen
The level can be changed using the ↓↑ keys or with the mouse.
The left and right Ctrl buttons can be used to present the tone for the left and right ears.
Depending on the different setting the spacebar can be used as a tone presenter.
The level is displayed as marker as well as in numerical values in the audiogram and above the
audiogram, respectively.
The measuring frequency can be adjusted using the cursor or with the mouse click. The
hearing threshold can be measured several times, with each new measurement overwriting
the previous ones. The measured values are automatically incorporated into the threshold
curve if only one intermediate frequency is sampled.
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MA33 Operating Manual
6.3 Air Conduction Screening
Select “Screening“
Screening“ in the lower-middle
middle part of the start screen.
screen
Figure 24 - Start screen – Screening activated
The setting is as followed:
followed Intensity 20 dB (changeable
changeable under
under “Setting“, “Function Keys“,
“Screening“),
Screening“), Frequency 1KHz, pulse tone. The measurement will start with the right ear.
ear
Test the frequency:
frequency It begins at 1 KHz.
The right arrow key increases the frequency while the left decreases it.
The test tone can be presented by pressing the spacebar.
The patient responds by pressing the Patient Response switch when a tone is heard. The
examiner can record the measured value by pressing the
th “Enter“
Enter“ key or with the center
button of the mouse.
mouse The red marking O is for the right and blue X is for the left ear.
ear
If the patient responds to all sounds, then the screening
screening result would be considered a “pass”.
“pass”
Forr hygiene purposes,
purpose the foam insert earphone tips should be discarded after each patient.
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MA33 Operating Manual
6.4 Bone Conduction Threshold
Figure 25 – Bone Conduction Start screen for MA33
Bone conduction, i.e. the transmission of sound waves through the skull directly to the inner
ear, provides information about the function of the inner ear, so to determine if the hearing
impairment is sensorineural or conductive in nature. In this case the possibility of a middle ear
hearing impairment can be excluded.
Preparing the Patient: Place the bone conduction headphone on the patient so that the
sound emission plate is directly against the mastoid i.e. palpable protrusion of the skull bone
just behind the ears. The other plate should be positioned around the temple area on the
other side of the head.
Measurement: Click on bone conduction to measure the bone conduction threshold. The
test procedure is similar to that of Air Conduction Threshold Measurement.
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MA33 Operating Manual
6.5 SISI-Test
The SISI (Short Increment Sensitivity Index) test is used to predict cochlear pathological
conditions.
The SISI test is started by pressing the SISI key. To train the patient to the SISI test,
louder increments such as of 5, 3, or 2dB are presented to the patient before the
actual test. The test tone is increased by 1 dB for a period of 0.2 seconds every 4.8
seconds.
Whenever the patient hears the increment, he/she presses the patient response switch. The
SISI test information and the test score are shown on the screen. The test will end
automatically after 20 presented increments.
6.5.1 Preparing for the Tests
The SISI Test start screen appears over the audiogram of the opposite ear on the screen when
the “SISI“ button on the start screen is activated. Click “R” or “L” to select the ear for testing:
The test level can be adjusted using the up/down arrow keys on the keyboard, and the
increment level can be adjusted using the page up/page down keys. The test is typically
conducted at 20dB SL to test for cochlear pathology; however, the level can also be raised to
75dB HL for detection of retrocochlear pathology.
Figure 26 Start screen MA33 SISI-Test
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MA33 Operating Manual
6.5.2 Training of the Patient
The patient must be given a thorough briefing and training to ensure consistent and accurate
results. The patient should be instructed to press the response key when a louder tone is
heard.
Press the start button or <S> key to start the SISI test.
By clicking on the arrows the intensity can be adjusted. For the training the intensity increases
by 5 dB every 5 seconds. For example, 60 dBHL to 65 dBHL.
Increment presentation can be identified when the light next to “Given” lights yellow on the
screen.
A green light next to “Identified” indicates that the patient pressed the Patient Response
Switch.
The cumulative number of identified increments increases as valid responses are registered.
If the patient demonstrates familiarity of the test by answering correctly, reduce the increment
level to 3 dB, and subsequently to 2 dB, for further training and familiarization.
6.5.3 Execution of the SISI-Tests
Use the page up/down keys to change the increment intensity level from 5-1dB.
If the patient is responding correctly to the familiarization, begin the SISI test with the
increments of 1 dB by clicking the start button. The following 20 signals will be presented
with incremental intensity and the examiner can track the progress on the test screen. The
intensity increase can be prolonged by tapping the spacebar.
The test stops automatically and the result will be displayed on the screen after 20 increments
have been achieved. The percentage of correctly-identified increments, together with the
total presented increments will be presented on the screen.
If the test result is satisfactory before twenty increments are presented, the test can be
terminated by pressing the “Stop” button.
The SISI test can be stopped and the result saved by clicking the “Exit“ key after 10
increments have been given.
The result will be shown automatically in the SISI table in the measuring screen. The total
incremental ratio of SISI test is expressed in percentage (Figure 27).
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MA33 Operating Manual
Figure 27 – SISI Testing Screen: Stop after 10 Increments
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MA33 Operating Manual
6.6 Speech Testing
Select the speech screen by clicking on the “speech” icon located in the upper-right
corner of the tone screen.
Figure 28- Speech Screen
6.6.1 Conducting a Speech Test
Select, test ear, transducer and adjust level just as in the tone test. Next, click on the
Wave file button and then select type of measurement (SRT, SAT, WRS, MCL, UCL).
Then click on the category of wordlist to use (i.e. adult, child, QuickSIN, Spanish).
Select a specific list from the category and the words will display on the screen. Click
on the word where the test should begin, then click the play button.
The words will automatically be presented to the patient when they are high-lighted
yellow. Use the incorrect/correct keys to score the word. It will be marked red for
incorrect or green for correct. To change the pause time between each word, click the
up/down arrows next to the “Interval” display on the bottom right of the word box.
When the test is finished, click the Stop button, then click “Store” to store the results
in the speech table displayed on the screen.
The audiogram can be displayed on the speech screen as well, by clicking on the icons
, for the left or right audiogram.
To conduct a speech test using the live-voice microphone, select the Microphone
button. The level of the microphone can be adjusted in the Speech Settings menu
under “Microphone.” Adjust the level until the VU meter peaks at green. Press F12 to
change to interrupter mode, if desired.
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MA33 Operating Manual
Figure 29 - Speech from CD-Rom Controls
To present speech that is pre-recorded on a CD, first insert the CD into the CD-Rom of
the computer. Then select the CD-Rom button in the MA33 software. The pause/play,
stop, and forward/back keys displayed on the screen will now control the CD. Press
the calibration button at the top of the screen to adjust VU meter to cal tone on CD.
Select the track on CD that contains the cal tone then press play. Click the arrows
located under calibration to adjust VU meters until the green bar is displayed.
Stop the CD track, then press OK to save the value.
26
MA33 Operating Manual
7
QuickSIN
TM
Purpose of the QuickSIN
TM
The primary complaint of hearing-impaired persons is difficulty in background noise.
The measurement of SNR loss (signal-to-noise ratio loss) is important because speech
understanding in noise cannot be reliably predicted from the pure tone audiogram
(Killion & Niquette, 2000).
The QuickSINTM test was developed to:
Provide a one-minute estimate of SNR loss
Provide a quick way for clinicians to quantify a patient’s ability to hear in noise
Assist professionals in choosing appropriate amplification and other assistive
technologies
Provide information useful in counseling patients regarding realistic
expectations
7.1 QuickSINTM Methodology
A list of six sentences with five key words per sentence is presented in four-talker
babble noise. The sentences are presented at pre-recorded signal-to-noise ratios which
decrease in 5-dB steps from 25 (very easy) to 0 (extremely difficult). The SNR’s used
are: 25, 20, 15, 10, 5 and 0, encompassing normal to severely impaired performance
in noise.
7.2 Calibration
A calibration file is included for the QuickSINTM lists. To check calibration, click on the
TM
QuickSIN button, select a list and click Calib. This will open the calibration window.
Play the calibration tone by clicking on the button, adjust the up/down arrow keys for
both channels until a green bar appears. Save the settings by clicking OK. The
calibration window will close, and the pull-down menu of QuickSINTM lists will still be
open. Click OK to display the list in the word-list box.
7.3 Presentation Level
For pure-tone average (PTA) < 45dBHL, set the attenuator to 70 dB HL. For PTA of 50
dBHL or greater, set the attenuator to a level that is judged to be “loud, but OK.” The
sound should be perceived as loud, but not uncomfortably loud.
7.4 Test Instructions
“Imagine that you are at a party. There will be a woman talking and several other
talkers in the background. The woman’s voice is easy to hear at first, because her
voice is louder than the others. Repeat each sentence the woman says. The
background talkers will gradually become louder, making it difficult to understand the
woman’s voice, but please guess and repeat as much of each sentence as possible.”
NOTE:
Use the pause button between sentences if the patient responds
slowly. This will also allow enough time for scoring the sentences.
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MA33 Operating Manual
7.5 Scoring
Five key words are scored in each sentence. The key words are displayed in capital
letters.
Each of the key words can be marked as correct (green) or incorrect (red)
using the computer mouse. Clicking once will mark the word correct; clicking twice
will mark it incorrect. Any words left unmarked will be scored as incorrect. All key
words in a sentence may be marked as correct or incorrect by clicking the
correct/incorrect buttons at the bottom of the speech screen.
When the test is finished, press Store. The condition of the test and SNR Loss will
automatically be stored in the speech table.
(One point is given for each key word repeated correctly. SNR loss is calculated for
each list by using the formula: SNR Loss = 25.5 – Total correct words. More
information on this formula is provided below).
NOTE: For greater accuracy, two or more lists should be averaged (please see
next section).
7.6 Averaging Multiple QuickSINTM Lists
The MA33 audiometer will automatically calculate SNR Loss on multiple lists averaged
together. To do this, simply conduct a QuickSINTM test as stated above. Instead of
TM
pressing store, go back to the QuickSIN button, choose the next list to be averaged
into the score, and check the “Add” box. Then click OK. Conduct the test using this
new list. Continue in this manner until the number of desired tests have been “added’
and conducted. After the final list is scored, press Store. The SNR Loss displayed will
then be an average of all the lists added into the score.
7.7 What is SNR Loss?
We are interested in the patient’s performance in noise compared to normal-hearing
persons’ performance in noise. We consider this difference in performance the SNR
Loss.
Similar to the definition of pure tone hearing loss, SNR Loss is defined as the dB
increase in signal-to-noise ratio required by a hearing-impaired person to understand
speech in noise, compared to someone with normal hearing. A normal-hearing person
requires about +2dB signal-to-noise ratio (speech louder than the background noise by
2dB) to identify 50% of key words in sentences on the QuickSINTM test. The value of
SNR loss is derived from the SNR-50 (signal –to-noise ratio for 50% correct) score. A
hearing-impaired person who requires speech to be 8dB higher than the noise to
achieve a 50% correct score would have a 6dB SNR Loss.
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MA33 Operating Manual
7.8 Where does the number 25.5 come from?
First we need to explain where 27.5 comes from. Following the Tillman-Olsen (1973)
recommended method for obtaining spondee thresholds, we have a simple method for
estimating SNR-50 using nothing more than the total number of words correct. In the
Tillman-Olsen method, two spondees are presented at each level, starting at a level
where all spondees are repeated correctly and decreasing in two dB steps until no
responses are obtained for several words. The starting level plus 1 dB, minus the total
number of spondees repeated correctly, is the spondee threshold. The simple
arithmetic comes from the use of 2 dB steps and 2 words per step. If the audiometer
only has 5 dB steps, the corresponding method would use 5 words per step and take
the starting level plus 2.5 dB (half of the step size, just as in the case of 2 dB steps),
minus the total number of spondees repeated correctly.
The QuickSINTM has five words per step and 5dB per step. Our highest SNR is 25 dB so
we take 25 +2.5 = 27.5 minus the total number of words repeated correctly. This
gives what we call SNR-50, the signal-to-noise ratio required for a patient to repeat
50% of the words correctly. For example, if someone repeats all the words correctly
down to 15dB SNR and then misses everything beyond that point, they gave 15 correct
responses (five each at 25, 20, and 15 dB SNR). Since they scored 100% correct at 15
dB SNR and 0% correct at 10dB SNR, their SNR-50 would be about 25.5 dB, halfway
between 15 and 10. This is the value given by the formula 27.5-15 = 12.5 dB.
The formula for SNR Loss:
Since SNR-50 for normal hearing persons is 2dB, we subtract 2dB to derive the formula
for a patient’s SNR Loss: 25.5 – (Total words correct in 6 sentences)
SNR Loss
= SNR-50 – 2 dB
= 27.5 – (total words correct) – 2dB
= 25.5 – (total words correct)
To interpret the SNR loss score, see table below.
SNR LOSS
DEGREE OF SNR LOSS
EXPECTED IMPROVEMENT WITH DIRECTIONAL MIC
0-3 dB
Normal/near normal
May hear better than normals hear in noise
3-7 dB
Mild SNR loss
May hear almost as well as normals hear in noise
7-15 dB
Moderate SNR loss
Directional microphones help. Consider array mic.
>15 dB
Severe SNR loss
Maximum SNR improvement is needed. Consider FM system
29
MA33 Operating Manual
7.9 Reliability
TM
A QuickSIN score obtained in one minute from a single list is accurate to about 1.8 dB
at the 80% confidence level. By “about” we mean that 80% of the time (four times
out of five) the “true” score (obtained from many lists) will be within 1.8 dB of the
single-list test score. Statisticians would say we have “an 80% confidence level” that
the true QuickSINTM score will be within + 1.8 dB of the measured score. To put these
numbers in perspective, a typical clinical threshold is accurate to about 5dB at the 80%
confidence level. In other words, one time out of five a threshold can be expected to
be 5dB or more above or below the recorded value.
An 80% confidence level is normally adequate for clinical testing, where the results of
any one test are used in context with other factors. In the case of a test of SNR Loss,
for example, the clinician will already have formed an idea of the patient’s
communication difficulty from conversations with the patient. A 95% confidence level
is common for research and reporting, where a reduced risk of error is normally
required. Using a statistical criterion that gives a 95% confidence level reduces the
probability of error to one time in twenty.
The table below shows the number of lists required for a given accuracy for confidence
levels of 80%, 90%, and 95%.
TM
Number of Lists
1
2
3
4
5
6
7
8
9
95% C.I. +, in dB
2.7
1.9
1.6
1.4
1.2
1.1
1.0
1.0
0.9
90% C.I. +, in dB
2.2
1.6
1.3
1.1
1.0
0.9
0.8
0.8
0.7
80% C.I. +, in dB
1.8
1.3
1.0
0.9
0.8
0.7
0.7
0.6
0.6
Etymotic Research Inc. Used with permission.
The numbers in the table above are based on the rms average standard deviation of
1.4 dB in SNR found for the hearing-impaired subjects included in the Beta-site testing.
This figure comes from two numbers: a) the 1.3 standard deviation derived from the
combined individual test-retest scores, and b) the across-list standard deviation of 0.6
dB. If only normal-hearing subjects are used, the appropriate standard deviation drops
from 1.4 dB to 1.25 dB.
A standard deviation of 1.4 dB is slightly better than the standard deviation of 0.7 dB,
multiplied by the square root of five, would predict a standard deviation of 1.6 dB for
the QuickSINTM test which uses only one sentence at each level compared to five
sentences at each level on the SIN test. The more careful pre-selection of sentences
TM
used in the QuickSIN test may have contributed to the slightly better results.
30
MA33 Operating Manual
7.10 Comparison Between Two Conditions
TM
Averaging the results of several QuickSIN lists improves the reliability compared to a
single list. This is particularly important when QuickSINTM lists are used to compare two
conditions, often two hearing aids or hearing aid adjustments. In this case, the real
differences may not be large.
The table below gives the number of lists required for the comparison between two
conditions at the 80%, 90%, or 95% confidence level. For a critical difference of 1.9
dB, for example, four lists are required for each condition at the 95% level. For a
critical difference of 1.4 dB at the 95% confidence level, eight lists are required for
each condition. For a simple example, one list in each condition with the assumed
standard deviation of 1.4 dB gives a 95% confidence level of 1.96 x 1.41 x 1.4 = 3.9
dB.
To improve from 80% to 95% confidence level at a given criterion requires an
approximate doubling of test time. Example: Two lists in each condition gives a 1.8
DB critical difference at the 80% confidence level; four lists in each condition provide
1.9 dB at the 95% confidence level, and five lists in each condition provide 1.7 dB at
the 95% confidence level.
Lists per Condition
1
2
3
4
5
6
7
8
9
95% C.I. +, in dB
3.9
2.7
2.2
1.9
1.7
1.6
1.5
1.4
1.3
90% C.I. +, in dB
3.2
2.2
1.8
1.6
1.4
1.3
1.2
1.1
1.1
80% C.I. +, in dB
2.5
1.8
1.5
1.3
1.1
1.0
1.0
0.9
0.8
Etymotic Research Inc. Used with permission.
TM
(QuickSINTM is a Trademark of Etymotic Research Inc. Used with permission.)
31
MA33 Operating Manual
8 Ownership, Warranty and Disclaimer
8.1 Ownership
The Audiometry Software (hereinafter referred to as ”SOFTWARE“) is solely owned by MAICO
Diagnostic GmbH, Salzufer 13/14, D-10587 Berlin, Germany. By purchasing the SOFTWARE
entitles the buyer the right of usage, but not the ownership of the SOFTWARE. The
SOFTWARE is to be used in accordance to the agreed terms of usage provisioned by MAICO.
Copyrights
MAICO’s ownership of the SOFTWARE covers worldwide and is therefore protected against
any unauthorized copying of the SOFTWARE. Non conformity use of the SOFTWARE is strictly
prohibited.
8.2 Restrictions
You may not:
Reverse engineer or attempt in any manner to discover the source code of the Software.
Attempt to defeat any mechanisms in the software, including those mechanisms responsible
for password protection of data and limiting the number of concurrent users.
Rent, lease, sublicense or in any manner copy or transfer (except as permitted above) the
Software.
Obscure or obliterate any MAICO copyright or trademark notices which appear on the
Software, the documentation, the screen-display, or otherwise in connection with the
Software.
MAICO specifically calls your attention to the fact that any violation or infringement of above
restrictions will result in legal action.
8.3 Limited Warranty
MAICO warrants you that any physical media and physical documentation provided by MAICO
are free of defects in materials and workmanship. This limited warranty is effective for a
period of ninety (90) days from the original purchase date. If MAICO receives notification
within the warranty period of defects in materials or workmanship and determines that such
notification is correct, MAICO will replace defective media or documentation. DO NOT
RETURN ANY PRODUCT UNTIL YOU HAVE OBTAINED AUTHORIZATION TO DO SO FROM
YOUR SUPPLIER. The entire and exclusive liability and remedy for breach of this limited
warranty shall be limited to replacement of defective media or documentation supplied by
MAICO, and shall not include or extend to any claim for or right to recover any other
damages, including but not limited to, loss of profit, data, or use of the Software, or special,
incidental or consequential damages, or other similar claims, even if MAICO has been
specifically advised of possibility of such damages. In no event will MAICO’s liability for any
damages to you or any other person ever exceed the lowest list price or the actual price paid
for the license to use the software, regardless of the form of the claim.
32
MA33 Operating Manual
DISCLAIMER
MAICO COVERS, INCLUDING BUT NOT LIMITED TO; ALL WARRANTIES, REPRESENTATIONS
AND TERMS AND CONDITIONS, EITHER EXPRESSED OR IMPLIED; UNDER THE SPECIFIED
TERMS OF USE AND APPLICATION OF THE SOFTWARE FOR ITS SPECIFIC PURPOSE. ALL
OTHER TERMS AND CONDITIONS SHALL NOT APPLY.
Furthermore, MAICO does not guarantee that the SOFTWARE or Documentation is free of
bugs, or fulfill the relevant standards, requirement or needs of a user. In this case, all the
warranties, guarantees and terms and conditions on all MAICO delivered physical disk and
documentation shall be limited to the 90 days warranty period.
MAICO is not liable for any third party’s product, disks, software or documentation that is
used in conjunction with MAICO’s software or programs, but is not directly manufactured or
supplied by MAICO.
General Terms and Conditions
Any change made to this Agreement shall be notified in writing, agreed and signed between
both parties, namely the purchaser of the SOFTWARE and a representative of MAICO. In the
event that the essential purpose of the above remedy (limited warranty) is not fulfilled, all
other limited liability including the liability limits and exclusions of damage claims shall
continue to apply
This Software License Agreement shall be interpreted and construed according to, and
governed by, the laws of Jurisdiction of Republic of Germany.
In the event any legal or commercial dispute or controversy arising out of or relating to this
agreement; provided MAICO is in all case violated of the rights, to the SOFTWARE or other
intellectual property protection right related to the SOFTWARE; shall be presented under the
Jurisdiction of Germany in the court of Berlin.
The SOFTWARE is protected under both Copyright Law and the International Copyright
Treaties. Copying of the SOFTWARE is strictly prohibited except for copies made of the
SOFTWARE for backup purposes to protect data loss.
The SOFTWARE can be used by any number of users, on any number of computer, and in any
place provided that they are not on more than one display screen at the same time.
33
MA33 Operating Manual
8.4 Warranty, Maintenance and After-Sales Service Hardware
The MA33 audiometer is guaranteed for 1 year. This warranty is extended to the
original purchaser of the instrument by MAICO through the Distributor from whom it
was purchased and covers defects in material and workmanship for a period of one
year from date of delivery of the instrument to the original purchaser.
The audiometer 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
audiometer should be checked and calibrated at least once a year. This check has to be
carried out by your dealer.
When returning the instrument for repairs it is essential to also send the headphone,
bone conduction receiver and other accessories. Send the device to your dealer or to a
service center authorized by your dealer. Please also include a detailed description of
the faults.
In order to prevent damage in transit, please use the original packing if possible when
returning the instrument.
34
MA33 Operating Manual
9 Safety Regulations
9.1 Electrical safety:
safety
The MA33 is in compliance with Class BF of EN
60601-1.
1.
The instrument is not to be used in environments
dealing with explosive material or equipment.
9.2 Measurement Safety:
Safety
In order to ensure safety and quality of the
measurement, an annual inspection and
calibration should be done. The annual checks can
be done by one of MAICO’s authorized service
centers.
MAICO will not be liable for any failure to comply
with the specified inspection date, according to the
Medical Product Law.
The use of uncalibrated and uninspected
u
audiometer is strictly prohibited.
9.3 Instrument Handling:
Handling
The instrument should be checked once per week.
9.4 Operation:
Operation
The instrument should only be handled and
operated by trained personnel (audiologists,
hearing-aid
aid dispensers, ENT doctors or personnel
with similar qualifications).
35
MA33 Operating Manual
10. Technical Data
Air Conduction
Intensity
From -10 to 105 dBHL
Safety limit
Headphone
Audiometer Class
Intensity > 70 dBHL
Insert Earphones 3A
Class 4 compliance with EN 60 645-1
Bone Conduction:
Intensity
Bone conductor
Audiometer Class
SISI-Test:
Modulation Test signal
Masking
General Information:
Test signal
Test frequency
Intensity level
From -10 to 70 dBHL
40dB at 6 kHz,
60 dB at 0,5 and 4 kHz,
65 dB at 3 kHz)
B 71 with headband
Class 3 compliance with EN 60 645-1
4.8/0.2s; 5, 4, 3, 2dB (preparation), 4.8/0.2s; 1dB (Test)
Narrow Band noise masking, manually- or automatically
adjustable
Pure tone, Pulse- and Warble tone
0,125; 0,25; 0,5; 0,75; 1; 1,5; 2; 3; 4; 6; 8 kHz
5 dB
Name
EN 60601-1, EN 60645-1
Instrument compliance with Directive 93/42/EWG
for Medical Product Class II a
PC-connection
Operating System
Dimension
USB 1.1 or 2.0
Windows XP SP3 Windows 7 Professional (32bit/64bit)
MA33 (W x L x H/ W): 15,4 x10,3 x 2,7 cm / 300 g
Connecting port:
Connector assignment:
Connection load:
⊇ Bone Conduction
Headphone
⊄ ⊂ Air Conduction
Headphone L/R
⊆ Patient Response Key
Pole= Ground,
Top= Exit
Pole= Ground,
Top= Exit
Pole= Ground,
Top= Entrance
ZA= 4 ΣΩ, UA= 5 Veff
ZA= 10 ΣΩ, UA= 1 Veff
RI= 500 ΣΩ
1 x USB- Entrance
∈ PC- Connection
Please refer to Figure 1 on page 4 of this Operating Manual
36
MA33 Operating Manual
Checklist for Subjective Audiometer Testing
- Clean the ear and head cushion!
- Untangle all lines when necessary
- Are the headphone cushion in good
condition?
If not replace
- Are plugs and leads in good condition/
undamaged?
- Are all controls working properly?
- Is the Patient Response Key working
properly (if available)?
- Check batteries and renew if necessary?
Instrument:........................................
Manufacturer:…................................
Serial No.:.........................................
Examiner:........................................
Test Signal Quality
All the test frequencies in the below table indicate typical hearing level and can be
changed when necessary:
Masking: “B” for Buzz tone, “G” for Noise, “V” for signal distortion, “S” for
switching masking noise.
kHz
LL
KL
Right Ear
0,25
0,5
Level
1
2
3
4
6
8
Left Ear
0,25
0,5
1
2
3
4
6
30dBHL
50dBHL
70dBHL
30dBHL
50dBHL
* When noise “B”, “G”, “V” or “S” is blocked, inform the service center!
* When the test tone is heard at the masking ear, contact the service center!
37
8
kHz
MA33 Operating Manual
Air Conduction Audiogram
Right Ear
0,25 0,5
kHz
Level
1
2
3
4
6
8
Left Ear
0,25 0,5 1
2
3
4
6
8
kHz
Should
dBHV*
Is
dBHV
Left
Earpiece
Right
Earpiece
**
Left Earpiece
Is
dBHV
Right Earpiece**
* Should is the last measurement of the patient
**For inverted measurement please reattach the headphone
If the frequency difference between „Should“ and „Is“ for one ear averages more than
10 dB, contact the SERVICE CENTER!
Bone Conduction Audiogram
kHz
Right Ear
0,25 0,5 1
Level
2
3
4
6
8
Left Ear
0,25 0,5 1
2
3
4
6
8
kHz
Should
dBHV*
Is
dBHV
If the frequency difference between „Should“ and „Is“ for one ear averages more than
10 dB, contact the SERVICE CENTER!
Tested.............................................................................................
Date:...............................................................................................
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1162-0905 REV. C
03/11