Sibelsound 400: User Manual
Sibelsound 400: User Manual
Sibelsound 400: User Manual
AUDIOMETRY
USER MANUAL
ÍNDICE
Contents
DECLARATION OF CONFORMITY......................................... 7
SAFETY............................................................................... 9
1. INSTRUCTIONS FOR INSTALLATION AND USE.............. 13
1.1 INTRODUCTION.......................................................... 14
1.2. INTRODUCTORY INFORMATION................................ 15
1.3. SIBELSOUND 400 AUDIOMETER MODELS................... 16
1.4. LAYOUT OF CONTROLS, INDICATORS AND
CONNECTORS................................................................... 20
1.5. INSTALLATION AND START-UP.................................. 24
1.6. FUNCTION TREE........................................................ 30
1.7. PERSONALISING THE DEVICE.................................... 32
1.8. AUDIOMETRIC TESTS................................................ 45
1.9. PROCEDURE FOR TONE AUDIOMETRY ....................... 50
1.10 PROCEDURE FOR SISI TEST ..................................... 66
1.11. PROCEDURE FOR SPEECH AUDIOMETRY TEST . ....... 73
1.12. PROCEDURE FOR PERFORMING THE FOWLER TEST.. 80
1.13. TONE DECAY TEST PROCECURE................................ 85
1.14. LUSCHER TEST PROCEDURE..................................... 91
1.15. WEBER TEST PROCEDURE........................................ 97
1.16 PURE TONE HF TEST PROCEDURE........................... 103
1.17. PROCEDURE FOR FREE AUDIOMETRY..................... 109
1.19. PRINTING AND SAVING AUDIOMETRIC TESTS...... 111
1.20. COMMUNICATIONS SYSTEMS................................ 125
1.21. UPDATING THE UNIT FIRMWARE........................... 128
1.22. MAINTENANCE PROGRAM...................................... 129
2. TECHNICAL SPECIFICATIONS..................................... 141
2.1 TYPES OF TESTS....................................................... 142
2.2. SIGNAL GENERATORS.............................................. 142
2.3. CONTROL OF SIGNAL LEVELS ................................. 145
Instruction manual
Contents
Instruction manual
Contents
Instruction manual
DECLARATION OF CONFORMITY
Declaration of Conformity
The SIBELSOUND 400 Audiometer has been designed
and manufactured in accordance with the SIBEL S.A.
Quality Manual which complies with quality standard EN ISO
13485:2004 and ISO 9001:2000, as well as with European
Medical Devices Directive 93/42/EEC. In accordance with the
latter directive this is a class IIa device.
It also complies with the following standards:
Revised Approved
Date: January 2009 Date: January 2009
SAFETY
Safety
SPECIAL PRECAUTIONS
INTENDED USE
ELECTRICAL RISKS
RISK OF EXPLOSION
Safety
DO NOT use this equipment in the presence of anaesthetics or
inflammable gases. THIS COULD CAUSE AN EXPLOSION.
INTERFERENCE RISK
1.1 INTRODUCTION
Chapter 1: Instructions for Installation and Use
WARNING
IF YOU FIND ANY DAMAGE TO THE PACKAGING, YOU
SHOULD IMMEDIATELY CONTACT THE TRANSPORT
AGENCY AND THE DISTRIBUTOR BEFORE PROCEEDING
TO INSTALL. YOU MUST NOT DISCARD THE PACKAGING,
BAGS, ETC. BEFORE THOROUGHLY VERIFYING THAT THE
EQUIPMENT FUNCTIONS CORRECTLY.
Instruction
Instructionmanual
manual 16
16
SIBELSOUND 400 A
SIBELSOUND 400 AM
SIBELSOUND 400 AO
SIBELSOUND 400 AOM
SIBELSOUND 400 AOM+
SIBELSOUND 400 SUPRA
305-600-050 1 CABLE USB TIPO A-B 2.0 / USB CABLE TYPE A-B 2.0
1
520-760-000 MODULO RS232 / RS232 MODULE
NOTA:
- LOS ARTÍCULOS Y CANTIDADES RELACIONADAS ANTERIORMENTE HAN SIDO CUIDADOSAMENTE COMPROBADAS. EN CASO DE FALTAS O
DESPERFECTOS PROCEDAN A COMUNICÁRNOSLO LO MAS PRONTO POSIBLE.
- SI DETECTA ALGÚN DETERIORO EN EL EMBALAJE, CONTACTE INMEDIATAMENTE CON LA AGENCIA DE TRANSPORTE Y CON SU DISTRIBUIDOR
ANTES DE PROCEDER A INSTALARLO. NO SE DEBE DESPRENDER DE LOS EMBALAJES, BOLSAS, ETC. HASTA QUE VERIFIQUE TOTALMENTE EL
CORRECTO FUNCIONAMIENTO DEL EQUIPO.
- SÍRVANSE DEVOLVERNOS UNA COPIA DEL ALBARAN SELLADA Y FIRMADA.
- EN CASO DE DEVOLUCIÓN DE MATERIAL O EQUIPO EN DEPOSITO, ROGAMOS NOS LO ENVÍEN EN PERFECTO ESTADO, COMPLETO DE ACCESORIOS
Y DEBIDAMENTE EMBALADO. CUALQUIER DESPERFECTO OCASIONADO PROVOCARÍA UN CARGO CORRESPONDIENTE A LA REPARACIÓN O
REPOSICIÓN.
NOTE:
- THE ITEMS AND QUANTITIES RELATED BEFORE HAVE BEEN CAREFULLY CHECKED. IN CASE OF ANY PART IS MISSING OR IS DAMAGED,NOTIFY US
AS QUICKLY AS YOU CAN.
- IF YOU DETECT ANY DAMAGE IN THE PACKAGING, CONTACT WITH YOUR DISTRIBUTOR BEFORE PROCEEDING TO INSTALL IT.
- DO NOT THROW AWAY THE PACKAGING, BAGS, ETC. UNTIL THE CORRECT FUNCTIONING OF THE DEVICE IS VERIFIED
- IN THE CASE OF RETURNING THE GOODS, IT WILL BE APPRECIATED THAT YOU SEND THE DEVICE IN PERFECT ORDER, WITH ALL THE
ACCESSORIES AND PROPERLY PACKAGED. ANY DAMAGE SUFFERED WILL MAKE A CHARGE CORRESPONDING TO REPAIR OR NEW PARTS.
WARNING
MANUFACTURER'S RESPONSIBILITIES
CONNECTORS
FRONT PANEL
1
4 11 12
5 6 7 10
8 9
13 14
15
16 17 18 19
Instruction manual 21
1- Display.
REAR PANEL
5 4 3 2 1 14
Instruction
64
Instructionmanual
manual
10 11 16 16 17 15
13 12 9 7 8 6
22
22
Instruction manual 23
1- Bone Conduction
4- Patient Microphone
5- Doctor's Microphone
7- Free field
8- Auxiliary input
9- Intercom headset
• Storage temperature 0 to 60 °C
RS MODULE INSTALLATION
Chapter 1: Instructions for Installation and Use
START-UP
Chapter 1: Instructions for Installation and Use
SIBELMED
SIBELSOUND 400
Both the keyboard and screen are located on the front panel
of the device.
Printer
All models can be connected, whether as a standard feature
or an option, to an external printer, if this option has been
selected previously in the Configuration. In this event, follow
the instructions for the relevant printer.
Attenuators
You can change the channel which controls an attenuator.
This allows you to control both channels with the same
attenuator.
To do so, press the relevant attenuator (the one you wish to
take control) for 1 second. On effecting the change an indication
appears (RIGHT <- / -> LEFT) for a few seconds, showing
the new channel controlled by the particular attenuator.
The volume of the signal from the doctor and the sensitivity
Chapter 1: Instructions for Installation and Use
The key returns to the previous menu (if this key is held
down for more than 1 seconds it returns to the Main Menu).
When the device is turned on, the screen for the test which
has been configured appears (default test is the Free test).
On turning the device on for the first time, the two configurations
are the same. The configuration which is loaded at the start
is the user's.
The sub-section INITIAL CONFIGURATION explains the
procedure for selecting a particular initial configuration.
PERSONALISING DIAGNOSIS
MENU
2. CONFIGURATION
2 Select
CONFIGURATION
4. DIAGNOSIS
PERSONALISING FREQUENCIES
Chapter 1: Instructions for Installation and Use
MENU
2. CONFIGURATION
CONFIGURATION
5. FREQUENCY
FREQUENCY
1. FREQ. SEL.
2 Select
CONFIGURATION
5. SEL. FREQ
MENU
2. CONFIGURATION
Instruction manual 35
2 Select
FREQUENCY
1. MUSICAL FREQ.
3 Use the attenuators to choose whether or not you want to
use musical frequencies and press “ENTER”.
FREQUENCY
Mus. Freq. ON(*)
option selected:
Chapter 1: Instructions for Installation and Use
A HZ C A HZ C
60 1000* 60
PERSONALISING PRINTING
MENU
2. CONFIGURATION
2 Select
CONFIGURATION
6. PRINTER
3 Choose the printer you wish to use
PERSONALISING LANGUAGE
To personalise language:
MENU
2. CONFIGURATION
2 Select
MENU
7. LANGUAGE
Instruction manual 37
MENU
3. MAINTENANCE
2 Select
MAINTENANCE
2. CALIBRATION
CALIBRATION
1. ANSI / ISO
ANSI / ISO
F1: YES F3: NO
MENU
Chapter 1: Instructions for Installation and Use
3. MAINTENANCE
2 Select
MAINTENANCE
2. CALIBRATION
CALIBRATION
2. CAL. WARNING
3 The following screen appears
Last Calibration
01-05-08
Press
Maint. Interval
Days: 365
WARNING
It is not advisable to change the date once it has been
MENU
3. MAINTENANCE
2 Select
MAINTENANCE
2. CALIBRATION
CALIBRATION
3. DEFAULT CAL
3 The following screen appears
DEFAULT CAL
F1: YES F3: NO
PERSONALISING CONTRAST
MENU
2. CONFIGURATION
2 Select
CONFIGURATION
8. CONTRAST
3 Choose the required contrast.
MENU
2. CONFIGURATION
2 Select
CONFIGURATION
9. DATE - TIME
Instruction manual 41
3 Use the attenuators to navigate through the various fields.
AUTOMATIC MASKING
MENU
6. AUTO MASK
2 Use the attenuators to select whether or not to use automatic
masking and press .
AUTO MASK
Auto Mark ON (*)
HIGH FREQUENCY
Chapter 1: Instructions for Installation and Use
MENU
1. TEST
MENU
9. FREEE
2 Press simultaneously + o
+ keys.
HIGH FREQ
High Freq ON (*)
INITIAL CONFIGURATION
1 Set the controls to the positions which you would like them
to be in when the audiometer is turned on.
2 Access each of the tests and select: the values for the
attenuators, the conduction route, the mode, the source and
the frequency.
Instruction manual 43
MENU
2. CONFIGURATION
CONFIGURATION
1. SAVE CONF.
Press to confirm
Instruction
Instructionmanual
manual 44
44
SAVE CONF.
Chapter 1: Instructions for Installation and Use
CONF. SAVED
Once this has been done, the audiometer will set itself in the
selected position each time it is turned on.
DEFAULT CONFIGURATION
MENU
2. CONFIGURATION
2 Select
CONFIGURATION
2. MODIF DEFAULT
3 The following message appears:
MODIF. DEFAULT
F1: YES F3: NO
Press to confirm
Instruction manual 45
MODIF. DEFAULT
DEFAULT CHANGED
MENU
2. CONFIGURATION
2 Select
CONFIGURATION
3. RESET DEFAULT
RESET DEFAULT
F1: YES F3: NO
Press to confirm
RESET DEFAULT
DEFAULT RESET
For ease of use, the Main Menu allows you to access the
Chapter 1: Instructions for Installation and Use
These tests include other variants that are not included. The
procedures for the latter fall to the specialist to determine.
For anyone not familiar with these techniques, we recommend
reference to relevant literature.
TONE AUDIOMETRY
SISI TEST
SPEECH AUDIOMETRY
FOWLER
Instruction
Instructionmanual
manual 48
48
Chapter 1: Instructions for Installation and Use
The Fowler test is used to verify the balance between the two
ears. This involves comparing equal sound intensity between
the two ears at the same frequency. This is aimed more at
predominantly unilateral deafness: the two ears must not
be identical. This test is performed to ascertain whether
recruitment occurs when the hearing threshold is normal or
less than 30 dB and the other ear shows a hearing loss of 25
to 60 dB. It is also called ABLB (Alternate Binaural Loudness
Balance).
TONE DECAY
LUSCHER
PURE TONE HF
FREE AUDIOMETRY
GENERAL CONSIDERATIONS
Technician
The technician performing the test must be trained in the
theory and practice of audiometric testing, since they will have
to take decisions such as:
• Which ear to test first? (Usually the one the patient thinks
has the better hearing function)
Test duration
Patient exhaustion should be avoided, as it can be difficult to
obtain results if the test lasts longer than 20 minutes and the
patient is not allowed any rest time.
Instruction manual 51
Ambient Conditions
We recommend installing the audiometer together with a
Patient preparation
Recent exposure on the part of the patient to elevated noise
levels could cause a temporary increase in hearing thresholds.
Therefore, high noise levels should be avoided before the
test or this should be indicated on the report. To avoid errors
due to physical effort, we recommend that the patient be at
the location of the test at least five minutes before it takes
place.
An otoscopic examination is usually carried out by a qualified
person, to establish whether there is an obstruction in the
external ear canal that needs to be removed.
It is vital that the patient is comfortably seated, calm and
rested so they can give maximum attention to the test.
Patient instructions
The technician carrying out the test must explain to the patient
what it involves, and also the following:
• The patient must respond when they hear the tone, not
when they think they hear it.
ABCDEFGHIJKLMNOP
ABCDEFGHIJKLMNOP
On the first line:
MENU
Chapter 1: Instructions for Installation and Use
1. TESTS
TESTS
1. PURE TONE
A HZ C A HZ C
60 1000 60
3 Push the
NEW PATIENT
Ref:
Enter the reference and press
SAVE PREVIOUS
F1: YES F3: NO
NEW TEST
F1: YES F3: NO
Instruction manual 55
4 Press
A HZ C A HZ C
AIR AIR
5 Press
A HZ C A HZ C
TONE TONE
6 Press
Instruction
Instructionmanual
manual 56
56
Chapter 1: Instructions for Installation and Use
A HZ C A HZ C
CONTIN. CONTIN.
A HZ C A HZ C
60 1000 60
• To apply the signal to the patient press the or
WARNING:
THIS DEVICE IS PROVIDED WITH A PROTECTION
SYSTEM THAT PROTECTS THE TDH39 AERIAL
HEADPHONES FROM SIGNALS THAT ARE TOO HIGH
DURING PROLONGED PERIODS OF TIME. AS A RESULT,
AT CERTAIN FREQUENCIES THE SIGNAL DEACTIVATES
AUTOMATICALLY AFTER A FEW SECONDS AT MORE THAN
100 DB.
The signal indicator looks like this
Instruction manual 57
A HZ C A HZ C
60 II 1000 60
You can switch from one option to the other by holding down
• SCREENING AUDIOMETRY
As explained earlier, this manual explains the mechanism
for carrying out various audiometric investigations. This
is not the only possible mechanism and must therefore
be adapted to the criteria which the specialist regards
as most appropriate in each case.
A description of each type of tone audiometry in
accordance with standard ISO 8253-1, is shown below
Hz 125 250 500 750 1000 1500 2000 3000 4000 6000 8000
Max dB HL 80 100 120 120 120 120 120 120 120 110 110
Min. dB HL -10 -10 -10 -10 -10 -10 -10 -10 -10 -10 -10
Once the steps described above have been carried out, you can
proceed to determine the hearing thresholds in each ear.
WARNING
IF YOU WISH TO SAVE THE THRESHOLDS TO PRINT
THEM AS A GRAPH, SAVE THEM IN THE INTERNAL
DATABASE AND/OR TRANSFER THEM TO A DATABASE
IN A PC, SEE SECTION 1.14 PRINTING AND SAVING
AUDIOMETRIC TESTS.
The test tone is continuous and has a duration between 1 and
2 seconds. The signal is applied in "direct" mode using the
Instruction manual 59
NOTE:
When the patient presses the response button, the
response is displayed on the screen and the decibel level
of the signal applied is shown blinking.
If the patient presses the button in the absence of
a signal, the message “NO SIGNAL” appears on the
screen.
4 On the graph of the ear being tested, write down the hearing
threshold level which corresponds to the lowest level at which
the number of patient responses exceeds half the number of
ascents.
Note:
If the lowest response levels for a particular frequency differ
by more than 10 dB, the threshold hearing level should
be regarded as dubious and it is advisable to repeat the
process.
If there is a difference greater than or equal to 15 dB between
two correlative frequencies, the audiometry can be considered
doubtful, unless this represents a sustained gradient along the
curve. In the event of neurosensory hypoacusia with a serious
loss of high frequencies, there tends to be more than 15 dB
between two correlative frequencies, but the whole curve
exhibits that gradient.
To avoid the test tone being heard by the ear other than the
one being tested, it is necessary to apply a masking noise to
that ear.
Hz 125 250 500 750 1000 1500 2000 3000 4000 6000 8000
Max dB HL 60 80 100 100 100 100 100 100 100 100 90
Min. dB HL -10 -10 -10 -10 -10 -10 -10 -10 -10 -10 -10
1 Apply a test tone to the ear being tested with a level equal
to the hearing threshold without masking. Select narrow band
noise NBN in the other audiometer channel and apply a level of
effective masking to the other ear that is equal to the hearing
threshold level of the latter.
Increase the level of masking until the test zone is inaudible
or until it exceeds the level of the test tone.
than 10 dB. This level of masking (which is the level from which
no subsequent increase in the level of tone was required to
make it audible) is the correct level and this process should
have resulted in the correct hearing threshold for the test
frequency. Make a note of the correct level of masking.
WARNING
THE BONE CONDUCTION VIBRATOR IS A VERY FRAGILE
COMPONENT, AND EVEN SMALL IMPACTS CAN LEAD
TO A DETERIORATION IN ITS CHARACTERISTICS.
THEREFORE, YOU ARE ADVISED TO HANDLE IT WITH
GREAT CARE.
SCREENING AUDIOMETRY
A HZ C - HZ C
40 1000 40
subject detects both tones, they have passed the test at this
frequency. If only one tone was heard, present another tone.
If the third tone has been detected, the subject has passed
the test at this frequency. If the third tone or the first two
tones were not heard by the subject, they have not passed
the screening test at this frequency.
6 Once the right ear has been tested, repeat the process
described in points 4 and 5, blocking the right channel signal
and activating the left, according to
- HZ C A HZ C
40 1000 40
(The dB level specified is a guideline)
A Rxx S A Sxx S
ABCDEFGHIJKLMNOP
and that they will hear a pure continuous tone and from time
to time detect a jump in the volume of the tone.
MENU
1. TEST
TEST
2. SISI
A R00 S A S00 -
60 1000 60
NEW PATIENT
Chapter 1: Instructions for Installation and Use
Ref:
SAVE PREVIOUS
F1:YES F3:NO
NEW TEST
F1:YES F3:NO
Select F1 to delete all the thresholds saved for the current test
and start the test again.
4 Press
Instruction manual 71
A R00 S A S00 -
air air
5 Press
A R00 S A S00 -
SISI DISAB.
A R00 S A S00 -
60 1000 60
A R00 S A S00 -
INC 1.0 FREQ 1
you are NOT pressing the key. (Similarly for the left
channel)
frequency.
13 Once all frequencies have been tested for the right ear,
the test proceeds with the left ear.
An audiometric file output via a printer is shown at the end
of this chapter.
ABCDEFGHIJKLMNOP
ABCDEFGHIJKLMNOP
On the first line:
Select with .
AB Number of words
Select with right attenuator, (number of questions NQ) to
ask the patient during the test.
MENU
1. TEST
TEST
3.SPEECH
A SP C A SPA C
60 00/10 60
NEW PATIENT
Ref:
SAVE PREVIOUS
F1:YES F3:NO
SAVE PREVIOUS
F1:YES F3:NO
Select F1 to delete all the thresholds saved for the current test
and start the test again.
4 Press
A SP C A SP C
AIR AIR
5 Press
Using the corresponding attenuator, select the signal source:
speech audiometry (SP), or masking with speech noise
(SPN).
A SP C A SP C
SPEECH SPEECH
6 Press
Using the corresponding attenuator, select the mode of
Instruction
Instructionmanual
manual 78
78
A SP C A SP C
CONTIN. CONTIN.
A SP C A SP C
60 00/10 60
ABCDEFGHIJKLMNOP
ABCDEFGHIJKLMNOP
MENU
1. TESTS
TESTS
4. FOWLER
A HZ C A HZ C
60 1000 60
NEW PATIENT
Ref:
Instruction manual 83
SAVE PREVIOUS
F1: YES F3: NO
NEW TEST
F1: YES F3: NO
NEW PATIENT
Age:
NEW PATIENT
Sex: Male
A HZ C A HZ
Chapter 1: Instructions for Installation and Use
AIR AIR
Use the corresponding attenuator to select the application
conduction of the signal for each channel: aerial (A), or
disabled (-).
5 Press
A HZ C A HZ
TONE TONE
6 Press the
A HZ C A HZ
CONTIN. CONTIN.
A HZ C A HZ
60 1000 60
A HZ C A HZ
60 1000 60
FOWLER TEST
THRESHOLD SAVED
DEL. THRESHOLDS
F1:YES F3: NO
ABCDEFGHIJKLMNOP
ABCDEFGHIJKLMNOP
The test starts by applying the tone using the SIGNAL key
in "direct" or "inverted" mode for 60 seconds if the response
persists. Otherwise, the tone level is increased.
Instruction
Instructionmanual
manual 88
88
Chapter 1: Instructions for Installation and Use
MENU
1. TESTS
TESTS
5. TONE DECAY
And access the test by pressing the .
A HZ C A HZ C
60 1000 60
3 Press the :
Instruction manual 89
NEW PATIENT
SAVE PREVIOUS
F1: YES F3: NO
NEW TEST
F1: YES F3: NO
NEW PATIENT
Age:
NEW PATIENT
Sex: Man
4 Press the
Instruction
Instructionmanual
manual 90
90
Chapter 1: Instructions for Installation and Use
A HZ C A HZ
AIR AIR
5 Press
A HZ C A HZ
TONE TONE
6 Press the
A HZ C A HZ
CONTIN. CONTIN.
A HZ C A HZ
60 1000 60
Instruction manual 91
In this test the intensity level and its duration are recorded.
To save the threshold the must be pressed. The
following screen will appear:
characters each.
Chapter 1: Instructions for Installation and Use
ABCDEFGHIJKLMNOP
ABCDEFGHIJKLMNOP
On the first line:
MENU
1. TESTS
TESTS
6. LUSCHER
A HZ M A HZ M
60 1000 60
3 Press the :
NEW PATIENT
Ref:
SAVE PREVIOUS
NEW TEST
F1: YES F3: NO
NEW PATIENT
Age:
NEW PATIENT
Sex: Man
A HZ M A HZM
AIR AIR
Use the corresponding attenuator to select the application
conduction of the signal for each channel: air (A), or disabled
(-).
Instruction
Instructionmanual
manual 96
96
Chapter 1: Instructions for Installation and Use
5 Press
A HZ M A HZ M
TONE TONE
6 Press the
A HZ M A HZ M
MODULA. MODULA.
A HZ M A HZ M
60 1000 60
A HZ M A HZ M
60 1000 60
A HZ M A HZ M
LUSCHER TEST
THRESHOLD SAVED
characters each.
ABCDEFGHIJKLMNOP
ABCDEFGHIJKLMNOP
MENU
1. TESTS
TESTS
7. WEBER
B HZ C - HZ C
60 1000 60
3 Press the :
NEW PATIENT
Ref:
SAVE PREVIOUS
F1: YES F3: NO
NEW TEST
F1: YES F3: NO
NEW PATIENT
Age:
NEW PATIENT
Sex: Man
4 Press the
B HZ C - HZ C
BONE DISABLED.
5 Press
Instruction
Instructionmanual
manual 102
102
Chapter 1: Instructions for Installation and Use
B HZ C - HZ C
TONE TONE
Use the corresponding attenuator to select the source of the
signal for each channel: in this case only the frequency in Hz
of the pure tone (HZ).
6 Press the
B HZ C - HZ C
CONTEN. CONTEN.
B HZ C - HZ C
60 1000 60
B HZ C - HZ C
60 1000 60
In this test, the side and the frequency at which the patient
states hearing with the greatest intensity are recorded. To
save the threshold the key must be pressed.
The following screen will appear:
WEBER TEST
THRESHOLD SAVED
ABCDEFGHIJKLMNOP
ABCDEFGHIJKLMNOP
Select with or .
MENU
1. TESTS
TESTS
8. PURE TONE HF
A HZ C A HZ C
60 8000 60
NEW PATIENT
Ref:
SAVE PREVIOUS
F1: YES F3:NO
NEW TESTS
F1: YES F3:NO
NEW PATIENT
Age (y):
NEW PATIENT
Sex: Man
A HZ C A HZ C
AIR AIR
A HZ C A HZ C
Chapter 1: Instructions for Installation and Use
TONE TONE
A HZ C A HZ C
CONTIN. CONTIN.
A HZ C A HZ C
60 8000 60
A HZ C A HZ C
60 8000 60
corresponding channel.
TONE HF TEST
THRESHOLD SAVED
SECURITY
Diagnoses are only calculated for Pure Tone and Pure Tone HF
tests. If both tests are realized, only Pure Tone test results
are shown.
A. Type of printer
• TONE AUDIOMETRY
• SISI TEST
• SPEECH AUDIOMETRY
• FOWLER
• TONE DECAY
• LUSCHER
• WEBER
• PURE TONE HF.
The process to follow when carrying out the tests you wish to
print is as follows:
The only proviso is that, once each hearing threshold has been
determined, along with the level for the channel corresponding
to that threshold, the key must be pressed for a
few seconds until the message "THRESHOLD SAVED" appears
on the screen. If masking is being applied to the other ear, it
must be at the right level before pressing .
WARNING
Saving of data is carried out independently for each
threshold and each level of masking, if applicable.
The device only saves the latest threshold detected
before pressing the key.
SAVE THRESHOLD
F1: YES F3:NO
SISI TEST
SPEECH AUDIOMETRY
FOWLER
In the Fowler test, once the signal has been applied to the
patient in both ears and the patient presses the button to
notify equal perception of level in both ears, press the ENTER
key to record the frequency and the intensity levels on the
machine.
LUSCHER
WEBER
PURE TONE HF
WARNING
FREE AUDIOMETRY
Having performed the tests, if you entered via this option you
can neither print nor save the results in the database.
test (TNL, SSI, SP, FWL, DEC, LCH, WBR, THF). The remainder
of the information depends on the type of test selected,
A SSI A
75% 1000 100%
A --- SP A ---
60 100% 75% 60
4. Fowler: threshold, frequency and conduction.
A FWL A
60 1000 60
A 15 DEC A
60 1000 60
conduction.
Chapter 1: Instructions for Installation and Use
A LCH A
0.3 1000 0.2
B WBR B
R.E.<L.E 1000
8. Pure Tone HF: Threshold, frequency, conduction and mask.
If masking has been applied, the level is indicated above the
threshold.
5 When carrying out more than one kind of test for the
same patient, it is not necessary to print a report after each
test separately. All the results can be printed together at the
end.
Each of these last three pages are only printed out if a Tone
Decay, Fowler, Weber, Speech or Pure Tone HF tests are carried
out or if more tan one diagnosis has been selected in the
configuration.
SAVING A TEST
TYPE OF TEST
TEST SAVED
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MENU
4. DATABASE
and press .
3 Then select
DATABASE
1. VER
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DELETE PATIENT
F1: YES F3:NO
12345 TONE
21-07-05 11:35
12345 TONE
PRINTING
• Select other tests for the same patient (if any), using the
attenuators.
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Chapter 1: Instructions for Installation and Use
MENU
4. DATABASE
and press .
3 Then select
DATABASE
2. CLEAR DB
CLEAR DB
F1:YES F3:NO
CLEARING DB
ıııııııııııııı
Warning:
This process destroys all information held in the Internal
Database and it can NOT be RECOVERED.
MENU
4. DATABASE
and press .
3 Then select
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Chapter 1: Instructions for Installation and Use
DATABASE
3. PAT. SEARCH
PATIENT SEARCH
Ref:
Enter the reference for the patient you wish to find using the
numeric keypad. If the patient is stored in the Database, the
following screen appears:
Rec 1/10
Ref: 12345
MENU
4. DATABASE
DATABASE
4. CLEAR PATIENT
DELETE PATIENT
F1:YES F3:NO
• USB (standard)
3 From the PC load the data in the database using the option
Import tests from the menu Options – Importing tests in the
W-50 Software.
5 From this point you can select, view or print any of the tests
imported or transferred to the PC.
Instruction manual 127
Any changes you make directly using the audiometer are also
updated on the computer screen.
WARNING:
DO NOT CANCEL THIS LOADING PROCESS ONCE IT HAS
BEEN STARTED.
MENU
3. MAINTENACE
TEST DEVICE
MAINTENACE
Chapter 2: Technical Specifications
1. TEST DEVIE
CPU TEST
This option allows you to check the device's CPU. Use the
attenuators to select the option:
TEST DEVICE
1. CPU
RESTART TEST
F1:YES F3:NO
LCD TEST
This option allows you to check the device's LCD. Use the
attenuators to select the option:
TEST DEVICE
2. LCD
Instruction manual 131
TEST DEVICE
3. KEYBOARD
The test will request the user to press each of the keys on
the keyboard.
PRINTER TEST
UPDATING PASSWORD
TEST DEVICE
5. UPDATE KEY
VERSION
TEST DEVICE
6. VERSION
RESET DEVICE
TEST DEVICE
7. RESET DEVICE
RESET DEVICE
F1:YES F3:NO
Warning:
THIS WILL ALSO RESULT IN THE LOSS OF BOTH USER
AND STANDARD CONFIGURATION, WHICH WILL BE
REPLACED BY THE DEFAULT FACTORY CONFIGURATION
OF THE DEVICE.
MONITOR
Monitor mode:
MAINTANCE
3. MONITOR
SPEECH-INTER
This menu is used to adjust the level of the devices used in the
Speech test and the intercom function (both optional).
• Technician headphones
Chapter 2: Technical Specifications
• Technician microphone
• Patient microphone
Intercom mode:
MAINTANCE
4. SPEECH-INTER
AUXILIARY
MAINTANCE
5. AUXILIAR
The following table shows the signal flow and the adjustment
options of the previous menus:
Instruction manual 135
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137
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Chapter 1: Instructions for Installation and Use
Instruction
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139
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140
Chapter 2: Technical Specifications
Instruction manual 141
TONE AUDIOMETRY
• Air conduction without masking
• Bone conduction without masking
• Air conduction with masking
• Bone conduction with masking
• Screening audiometry
• Free field
SISI TEST
SPEECH AUDIOMETRY
FOWLER
TONE DECAY
LUSCHER
WEBER
PURE TONE HF
FREE AUDIOMETRY
• Right ear
• Left ear
Instruction manual 143
SIGNAL SOURCES
• Pure tones
LF Frequency: 125, 250, 500, 750, 1000, 1500, 2000,
3000, 4000, 6000 , 8000 Hz
Accuracy: 1%
• Speech audiometry
Range: Variable
Inputs:
. Electret microphone
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• Continuous
• SISI test
Presentation of increases: Manual or automatic
Level of increases: 1, 2, 3, 4 or 5 dB
Presentation in automatic mode: Every 1, 2, 3, 4,
5, 6, 7, 8 or 9 seconds
Duration of increase: 50 ms signal rise, 200 ms signal
and 50 ms signal fall
Accuracy: 3%
• Alternated pulse
As per EN-60645-1 the same characteristics as
the above but alternating between the right and the
left channels.
• Range modulation
Frequency: 2.5 Hz ±1%
Range modulation: 0.2, 0.3, 0.4, 0.5, 0.6, 0.8, 1,
2, 3, 4 or 5 dB.
Rise and fall time: 50 ms
Level meter: Indicator on LCD Display.
Accuracy: 3%
• Alternated modulation
The same characteristics as the above but
alternating between the right and the left channels.
Instruction manual 145
• Jumps of 5 dB ±1 dB
• Jumps of 1 dB (Reference tone)
INTERCOM
MEMORY
• Type: SDRAM
• Capacity: more than 1000 aerial and bone tone tests in both
channels at frequencies of 500,1000,2000,3000 y 4000 Hz
Instruction manual 147
OUTPUTS
2.5. TRANSDUCERS
BONE CONDUCTION
• Vibrator B71
FREE FIELD
• Loudspeakers with integrated amplifier
ELECTRICAL SAFETY
EMC
AUDIOMETERS
CALIBRATION
AUDIOMETRY
Ambient Conditions
• Storage temperature: 0 to 60 °C
• Working temperature: 10 to 40 °C
• Relative humidity < 90% (no condensation)
POWER SUPPLY
POWER
• < 50 VA
DIMENSIONS
• Width: 390 mm
• Depth: 260 mm
• Height: 105 mm
WEIGHT
40:0000
RAM
3 MT48LC4M16A2P-75 Addr = 010 11 0 1 Addr = 110 11 0 0 3
1MB x 16 X 4 POTE Amplificador Osea
I2C AD5242 Amplifier Bone
LM1877
USB
ISP1362
PRINT DSP Test Fuente de Alimentación / Power Supply
5502 ADS7830 +12,+5,+3.3,+1.26 0,7A
0,3A
-12V +5V
2 Addr = 100 10 A1 A0 2
-12V -5V +5V +1.26V
Contraste /Contrast -5V +1.26V
LCD ALF AD5247 0,25A
10TQ100C
Diagrama de Bloques Audiometro / Block diagram audiometer
Fallos
failures LCD Der./right Size Document Number Rev
A4 520-725-010 0
Date: Sheet 1 of 1
A B C D E
MODULATOR
ATTENUATOR
SOURCE SELECTOR
ROUTE SELECTOR
AMPLIFIER
3.2. MICROPROCESSOR
PHYSICAL DESCRIPTION
• Peripheral components.
PROGRAM
DRAM MEMORY
Chapter 3: Operating Principles
FLASH MEMORY
DSP
CODEC
PERIPHERALS
CPLD
RTC
USB CONTROLLER
5.1. UPKEEP
WARNING:
THE BONE CONDUCTION VIBRATOR IS A VERY FRAGILE
COMPONENT, AND EVEN SMALL IMPACTS CAN LEAD
TO A DETERIORATION IN ITS CHARACTERISTICS.
4 Check that the signal key works correctly in both direct and
inverted modes.
OBJECTIVE CHECK
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Chapter 6: Modifications
6. MODIFICATIONS
Instruction
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168
Chapter 6: Modifications
Instruction manual 169
EN-IEC 61000-3-3
Instruction manual 171
The Sibelsound 400 is designed to be used in the electromagnetic environment specified below.
The customer or user of the Sibelsound 400 must ensure that it is used in such an environment.
EN-IEC 61000-4-4 ±1 kV for input/ ±1 kV for input/ The length of I/O lines is less
output lines output lines than 3 m.
Note that Ut is the alternating current power supply expected for the purposes of the test.
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Appendix 1: Electromagnetic compatibility
All models of the DEVICE are designed to be used in the electromagnetic environment specified below. The customer or user of the
SBELHOME Plus must ensure that it is used in such an environment.
Immunity Test EN-IEC 60601 test level Level of Guide – Electromagnetic Environment
compliance
7
d =[ ] P from 800 MHz to 2.5 GHz
3
Note 1 At 80 MHz and 800 MHz, apply the higher frequency margin
Note 2 These recommendations may not apply in all possible situations. Electromagnetic propagation can be affected by absorption
and reflection by structures, objects and persons.
a
The exact field intensities emitted by fixed transmitters, such as radiotelephone base stations (wireless cellular-mobile phones)
and mobile radios, radio hams, AM, FM and TV radio broadcasts, cannot be theoretically calculated. To determine the
electromagnetic environment due to fixed transmitters, consider carrying out electromagnetic measurements in the area of use.
In the event that the field intensity in the area of use is greater than the compliant level, check whether the behaviour of the
DEVICE is normal. If not, it may be necessary to take additional measures such as the reorientation or relocation of the DEVICE.
b
Above the 150 kHz to 80 MHz frequency range, the field intensity must be less than 3 V/m.
Instruction manual 173
3.5 7
d =[ ] P d =[ ] P
3 3
1 1.17 2.33
10 3.69 7.38
For transmitters with a maximum output power not listed above, the recommended separa-
tion distance d in metres (m) can be estimated using the relevant equation according to the
frequency of the transmitter, where P is the maximum power of the transmitter in Watts (W)
according to the manufacturer.
Note 2 These recommendations may not apply in all possible situations. Electromagnetic
propagation can be affected by absorption and reflection by structures, objects and persons.
Appendix 2: Compliance with the Organic Law on Data Protection
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DIRECTIVE 95/46/EC.
IMPORTANT WARNING
• According to current legislation, the user of this equip-
ment is the only party responsible for saving and processing
the details of his patients according to the Law.
• Observance of the recommendations included in this sec-
tion under no circumstances guarantees the full adaptation
of the user’s activity to the data protection regulation.
• Printing documents:
• Data transmission:
APPENDIX 3
CALCULATION TABLES FOR
DIAGNOSES
Instruction manual 179
1. “MINISTRY” DIAGNOSIS
Example:
Example:
2. “COUNCIL” DIAGNOSIS
Appendix 3: Calculation tables for diagnoses
Example:
Example:
Example:
Example:
Appendix 3: Calculation tables for diagnoses
4. ELI
Example:
5. SAL INDEX
Appendix 3: Calculation tables for diagnoses
Once this value has been obtained, Table 5 of the SAL Index
is used to present the evaluation.
For this test, the 500, 1000, 2000 and 4000 frequencies are
investigated, and the criteria set out in Table 6 are applied:
1. If the threshold is not higher than 25 dB at any frequency,
the diagnosis is:
“Normal”
6. If all the frequencies are affected and one or more are above
55 dB, the diagnosis is:
“Advanced hypoacusia by noise”
“Conversational loss”