Sibelmed Sibelsound 400 User manual

SIBELSOUND 400
520-700-MU2 • REV. 2.06 • 2019-03
USER MANUAL
AUDIOMETRY

SIBEL S.A.U., Rosellón 500 bajos, 08026 BARCELONA (Spain)
National Sales: Tel. [phone] e-mail: [email protected]
International Sales:Tel. [phone] e-mail: [email protected]
Technical service: Tel. [phone] e-mail: [email protected]
Fax: [phone] , Web: www.sibelmed.com

Contents
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520-700-MU2 • REV. 2.06
INDEX
SAFETY ............................................................................. 6
1. INSTRUCTIONS FOR INSTALLATION AND USE ............ 10
1.1 INTRODUCTION ........................................................... 11
1.2. INTRODUCTORY INFORMATION..................................... 12
1.3. SIBELSOUND 400 AUDIOMETER MODELS ....................... 13
1.4. LAYOUT OF CONTROLS, INDICATORS AND CONNECTORS . 17
2XF 1.6A H 250V............................................................... 19
1.5. INSTALLATION AND START-UP ...................................... 21
1.6. FUNCTION TREE ......................................................... 25
1.7. PERSONALISING THE DEVICE....................................... 27
1.8. AUDIOMETRIC TESTS .................................................. 41
1.9. PROCEDURE FOR TONE AUDIOMETRY ........................... 46
1.10 PROCEDURE FOR SISI TEST ........................................ 62
1.11. PROCEDURE FOR SPEECH AUDIOMETRY TEST .............. 68
1.12. PROCEDURE FOR PERFORMING THE FOWLER TEST........ 75
1.13. TONE DECAY TEST PROCECURE................................... 81
1.14. LUSCHER TEST PROCEDURE ....................................... 86
1.15. WEBER TEST PROCEDURE .......................................... 92
1.16 PURE TONE HF TEST PROCEDURE................................. 98
1.17. PROCEDURE FOR FREE AUDIOMETRY......................... 104
1.19. PRINTING AND SAVING AUDIOMETRIC TESTS............. 106
1.20. COMMUNICATIONS SYSTEMS.................................... 120
1.21. UPDATING THE UNIT FIRMWARE ............................... 122
1.22. MAINTENANCE PROGRAM......................................... 123
2. TECHNICAL SPECIFICATIONS ................................... 135
2.1 TYPES OF TESTS........................................................ 136
2.2. SIGNAL GENERATORS................................................ 136
2.3. CONTROL OF SIGNAL LEVELS .................................... 139
2.4. OTHER FUNCTIONS ................................................... 140
2.5. TRANSDUCERS ......................................................... 141
2.6. APPLICABLE STANDARDS ........................................... 141
2.7. GENERAL DATA......................................................... 144
2.8. SYMBOLS................................................................. 145
3. OPERATING PRINCIPLES .......................................... 147
3.1. RIGHT / LEFT CHANNEL ............................................ 150
3.2. MICROPROCESSOR ................................................... 151

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3.3. INTERCOM (Optional) ................................................ 153
3.4. FREE FIELD (Optional) ............................................... 153
4. AUDIOMETRY TECHNIQUE ........................................ 155
5. UPKEEP, PREVENTIVE AND CORRECTIVE
MAINTENANCE ......................................................... 157
5.1. UPKEEP ................................................................... 158
5.2. PREVENTIVE MAINTENANCE ....................................... 159
5.3. CORRECTIVE MAINTENANCE....................................... 160
6. MODIFICATIONS ...................................................... 163
APPENDIX 1 ................................................................. 165
ELECTROMAGNETIC COMPATIBILITY ............................ 165
APPENDIX 2 ................................................................. 171
COMPLIANCE WITH THE DATA PROTECTION REGULATIONS
................................................................................. 171
APPENDIX 3 ................................................................. 175
CALCULATION TABLES FOR DIAGNOSES ....................... 175

520-700-MU2 • REV. 2.06
Declaration of Conformity
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The SIBELSOUND 400 Audiometer has been designed
and manufactured in accordance with the SIBEL S.A.U. In
accordance with the latter directive.
Revised Approved
Date: 2019-03 Date: 2019-03
Antoni Picó Albert Grau
Technical Director Sales Director
PRODUCT CONFORMS WITH
93/42/EEC Medical Devices Directive
Class II a

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Safety
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SAFETY
SPECIAL PRECAUTIONS
The SIBELSOUND 400 audiometer has been designed to the
highest safety standards.
You should read all operating instructions carefully before
operating the device. Failure to do so could cause injury to
the user or patient and damage to the equipment and/or
accessories.
INTENDED USE
The audiometer generates a series of acoustic and vibrational
stimuli and calculates a series of parameters relating to human
audiometry.
The audiometer is intended for use by medical staff only, under
the supervision and instruction of a doctor.
The audiometer is not intended for use outdoors, nor in
conditions or with energy sources other than as set out in
this manual.
DO NOT use transducers (headphones for air/bone conduction,
loudspeakers, ...) that have not been calibrated with the
audiometer. THAT COULD INVALIDATE THE AUDIOMETRIC
TEST PERFORMED.
The device should be placed in a safe position to prevent falls
that may cause a damage to the equipment or harm to the
patient and/or user.
USER PROFILE
Prole of technical specialist or doctor:
The audiometer is designed to be used exclusively by health
personnel, being supervised and instructed by a doctor. Specic
training is recommended in the technique of Audiometry.
To obtain additional training on the technique or on product
contact SIBEL, S.A.U. or your usual provider.

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Prole of the patient:
Age:> 4 years until old age
Weight: without limitations
Height: without limitations
Health status: physical and mental condition necessary to
understand the doctor's instructions and to be able to indicate
the acoustic perceptions.
THE ROLE OF THE PATIENT IN THE USE OF THE
AUDIOMETER
The audiometry tests require the cooperation of the patient.
The patient must press a button to communicate the detection
of a stimulus. The doctor must evaluate the patient's ability
to carry out the audiometry tests. Special care must be taken
with children, the elderly and the handicapped.
LIMITATIONS OF USE. CONTRAINDICATIONS
Interpretation of test results and any resulting treatment must
be carried out by a doctor.
The medical staff must evaluate any symptoms presented by
the patient before any audiometric tests are carried out.
The suitability of audiometric testing is the responsibility of
the medical staff.
The audiometer should not be used when it is likely that
the validity of the results could be compromised by external
factors.
Take care NOT to place the equipment where it could be
splashed by water or other liquids or cover it with objects
that prevent air from circulating around it while it is running.
The device should NOT be used stacked or adjacent to other
equipment.
The equipment must be stored and used within the temperature,
pressure and humidity ranges specied in this manual.

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Safety
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ELECTRICAL RISKS
DO NOT tamper with the integrity of the system's electric
earth connection. Protection against electrical discharge is
provided by the connection of the chassis to an electrical
earth connection. The earth connection is only effective when
the three-wire power cable supplied with the equipment is
connected to a suitably earthed electrical socket.
DO NOT use multiple mains sockets, unless they comply with
EN-60601-1. They can degrade electrical safety.
DO NOT remove the device cover. Servicing and repair of
the apparatus must only be carried out by trained personnel.
Contact with the voltage inside the system can cause serious
injury.
DO NOT use the equipment if the power cable is in poor
condition or cracked.
DO NOT use the transducers if they are in poor condition.
NEVER immerse any part of the equipment in liquid.
THIS COULD CAUSE AN ELECTRICAL DISCHARGE.
To ensure safety in accordance with standard EN 60601-1,
only connect equipment which meets current electrical safety
standards to this instrument.
The generation of acoustic and vibration signals is considered
essential (in order to comply with the specied accuracy and/
or not affect the patient's diagnosis), the presentation of
results and the storage and integrity of the data in memory.
The communication with the computer, the printing of the
results or the intercommunication signals are not considered
essential operation, provided that the integrity of the data is
guaranteed and that no data is transmitted incorrectly.
RISK OF EXPLOSION
DO NOT use this equipment in the presence of anaesthetics
or inammable gases. THIS COULD CAUSE AN EXPLOSION.

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Safety
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INTERFERENCE RISK
This is an electronic product, so high frequency emissions can
interfere with its correct use. For this reason, products which
can cause interference (radios, mobile telephones, etc.) must
be kept away from the audiometer.
SibelSound 400 as an electronic device, and special precautions
regarding Electromagnetic Compatibility must be taken. The
device must be installed following the electromagnetic guide
in Annex 1.
The use of accesories and cables different from the specied
in this manual, can inuence patient safety or device safety
and they can produce also an increase of the emissions of the
device or a decrease of the inmunity of the device.
DISPOSAL OF ELECTRICAL OR ELECTRONIC DEVICES BY
DOMESTIC USERS IN THE EUROPEAN UNION
This symbol on the product indicates that it must not be
disposed of as part of domestic waste.
Rather, if it is to be disposed of, it is the user's responsibility
to take it to a designated recycling point for electrical and
electronic devices. The separate collection and recycling
of different kinds of waste at the point of disposal helps to
preserve natural resources and to ensure that recycling will
safeguard health and the environment. If you require further
information about where to take products of this type for
recycling, contact your local authority, the local domestic waste
disposal service or the distributor from whom you purchased
the product.

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1. INSTRUCTIONS FOR
INSTALLATION AND USE

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1.1 INTRODUCTION
The SIBELSOUND 400 clinical audiometer is a compact
two-channel device, the main components of which are a
tone generator, a noise generator, a set of headphones for air
conduction, a vibrator for bone conduction and an alphanumeric
liquid crystal screen. The whole system is controlled by a Digital
Signal Processor (DSP) that allows audiometric investigation
to be carried out quickly, simply and reliably to establish
hearing thresholds and to carry out screening tests such as
suprathreshold tonal tests.
The SIBELSOUND 400 audiometer has been developed
entirely in Spain, based on current technology and more than
20 years experience in the design and manufacture of this
kind of equipment. Its functional design and the elimination
of most of the electromechanical components have made
possible a device that can provide long service in the eld of
audiometric testing.
The SIBELSOUND 400 audiometer has been designed in
collaboration with Barcelona University's Surgery Department
(Otorhinolaryngology and Audiology) in the Faculty of Medicine
and recognised specialists in the area, and meets the standards
criteria of both national (U.N.E) and international institutions
(I.E.C., I.S.O., etc.).

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1.2. INTRODUCTORY INFORMATION
This instruction manual applies to all models and all options
which may be included in the SIBELSOUND 400 audiometer.
Accordingly, only those functions or options which are found
in your particular model will be relevant.
This audiometer is made from professional quality solid state
components, under strict quality control. However, accidents
can occur during the transport or storage of the equipment.
It is therefore advisable to carry out an initial check on its
condition, and that of the accompanying accessories, before
installation.
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.

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1.3. SIBELSOUND 400 AUDIOMETER MODELS
The SIBELSOUND 400 audiometer comprises six different
models:
SIBELSOUND 400 A
SIBELSOUND 400 AM
SIBELSOUND 400 AO
SIBELSOUND 400 AOM
SIBELSOUND 400 AOM+
SIBELSOUND 400 SUPRA
The table below shows each model's built-in features as
standard (Shadedo) and other items which can be included
as optional (White). You can upgrade to a higher model by
adding the relevant features at any time. All you need to do is
contact the SIBEL S.A.U. Sales Department or your distributor.

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RELACIÓN DE CONTENIDO / PACKING LIST Página 1 de 2
SIBELSOUND 400 520-708-010 REV. 5
07/11
MODELOS / MODELS
CÓDIGO
CODE
CANT.
QTY.
DESCRIPCIÓN
DESCRIPTION A A
M
A
O
A
O
M
A
O
M
+
S
U
P
R
A
__________ 1 SIBELSOUND 400 MODELO / MODEL SN: 207-
01217 1 CABLE CONEXIÓN DE RED 2m / MAINS PLUG CABLE 2m
03658 1 CABLE USB TIPO A-B 2.0 / USB CABLE TYPE A-B 2.0
01807 1 CONEXIÓN AVISO PACIENTE / PATIENT SWICHT
02260 1 ARICULARES VIA AEREA / EARPHONE SET
03078 1 SUPRESOR DE RUIDO VA / AUDIOCUPS AC
__________ 1 MANUAL DE USO DEL SIBELSOUND 400 (Doc. 520-700-MU1)
/ SIBELSOUND 400 USER MANUAL (Doc. 520-700-MU2)
__________ 1 GUIA RAPIDA DE USO SIBELSOUND 400 (Doc. 520-711-GR1)
/ SIBELSOUND 400 QUICK REFERENCE (Doc. 520-711-GR2)
03024 1
SOFTWARE AUDIOMETRÍA W-50 DEMO/ AUDIOMETRY DEMO
SOFTWARE W-50
02303
__________
1
1
LICENCIA SOFT. W-50 / W-50 LICENSE SOFT. (520-66A)
•MANUAL USO (Doc. 520-660-MU1) (Incluido en CD)/
USER MANUAL (Doc. 520-660-MU2)(Included in CD)
01507 1 BOLSA DE TRANSPORTE / CARRING BAG
07030
07430
1
1
MODULO RS232 / RS232 MODULE
•CABLE RS232 / RS232 CABLE
07029
01382
03623
03573
1
1
1
1
MODULO MONITOR-INTERCOMUNICADOR Compuesto por :
MONITOR MODULE Composed by:
•AURICULAR MONITOR / EARPHONE MONITOR
•MICROFONO PACIENTE ELECTRET-PINZA /ELECTRET
CLIP MICROPHONE
•ADAPTADOR JACK 3.5H/6.5M
00807
03623
07029
01382
03623
03573
1
1
1
1
1
1
OPCION FIRMWARE LOGOAUDIOMETRÍA Compuesto por:
SPEECHAUDIOMETRY FIRMWARE OPTION Composed by:
•MICROFONO DOCTOR ELECTRET-PINZA / ELECTRET
CLIP MICROPHONE
•MODULO MONITOR-INTERCOMUNICADOR Compuesto por
:
MONITOR MODULE Composed by:
oAURICULAR MONITOR / EARPHONE
MONITOR
oMICROFONO PACIENTE ELECTRET-PINZA
/ELECTRET CLIP MICROPHONE
oADAPTADOR JACK 3.5H/6.5M
02559
07431
1
1
OPCIÓN FIRMWARE CAMPO ABIERTO/ FREE FIELD
•JUEGO ALTAVOCES CAMPO ABIERTO/
FREE FIELD LOUDSPEAKER SET
02557
07429
1
1
OPCIÓN FIRWARE ALTA FRECUENCIA
•AURICULARES ALTA FRECUENCIA/ EARPHONE HIGH
FREQUENCY SET
--- --- ---

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RELACIÓN DE CONTENIDO / PACKING LIST Página 2 de 2
SIBELSOUND 400 520-708-010 REV. 5
07/11
CÓDIGO
CODE
CANT.
QTY.
DESCRIPCIÓN
DESCRIPTION A A
M
A
O
A
O
M
A
O
M
+
S
U
P
R
A
06408 1 OPCION FIRMWARE FRECUENCIAS INTERMEDIAS
INTERMEDIATED FREQUENCY SOFTWARE OPTION
06402 1 OPCION FIRMWARE FRECUENCIAS MUSICALES
MUSICAL FREQUENCIES FIRMWARE OPTION
06403 1 OPCION FIRMWARE ENMASCARAMIENTO SINCRONIZADO
AUTOMATIC MASKING FIRMWARE OPTION
06404 1 OPCION FIRMWARE TONO REFERENCIA
REFERENCE TONE FIRMWARE OPTION --- --- ---
02564 1 OPCION FIRMWARE SISIGRAMA
SISIGRAM FIRMWARE OPTION
00753 1 OPCION FIRMWARE BASE DE DATOS INTERNA
INTERNAL DATA BASE FIRMWARE OPTION
00755 1 OPCION FIRMWARE PRUEBAS SUPRALIMINARES
SUPRALIMINARY FIRMWARE OPTION
02558
02258
1
1
OPCIÓN FIRMWARE AUD. TONAL VIA OSEA
•VIBRADOR VIA OSEA / BONE VIBRATOR SET
00764 1 TONO PULSANTE/ALTERNADO Y MODULADO/ALTERNADO
ALTERNATED PULSE TONE AND ALTERNATED MODULE
06405 1 OPCION FIRMWARE RUIDO BANDA ESTRECHA
NARROW BAND NOISE FIRMWARE OPTION
00763 1 OPCION FIRMWARE FRECUENCIA Y AMPLITUD MODULADA
FREQUENCY AND AMPLITUDE MODULATION FIRMWARE OPTION
--- --- ---
06406 1 OPCION FIRMWARE ENMASCARAMIENTO RUIDO BLANCO
MASKING WITH WHITE NOISE FIRMWARE OPTION
06407 1 OPCION FIRMWARE ENMASCARAMIENTO RUIDO VOCAL
MASKING WITH SPEECH NOISE FIRMWARE OPTION
STANDARD OPCIONAL / OPTIONAL --- NO DISPONIBLE / NOT AVAILABLE
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.
PREPARADO/PREPARED BY ..................................... FECHA/DATE: / /

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WARNING
In accordance with the various standards, we recommend
testing and calibrating the electromedical equipment
periodically in order to guarantee reliable operation
of the functions and patient, user and environmental
safety.
In addition to the necessary routine maintenance of
the SIBELSOUND 400 audiometer, we recommend
calibrating the transducers and performing a general
check of the safety systems, adjustments, functions,
etc. at least once every twelve months (ISO 8253-1).
This should also be done whenever there is reason to
suspect that the equipment is malfunctioning.
These checks should be carried out by the maufacturer
or by qualied technical staff authorised by SIBEL S.A.U.,
in accordance with the manufacturer's (SIBEL S.A.U.)
Procedures for Verication and Adjustment.
MANUFACTURER'S RESPONSIBILITIES
SIBEL S.A.U. guarantees the safety, reliability and proper
functioning of this equipment provided that:
•The location where the equipment is installed complies
with the UNE (IEC) requirements for electrical installations,
with an earth connection, and such other standards as
may apply.
• Repairs, maintenance and modications, whether within
the warranty period or otherwise, are carried out by SIBEL
S.A.U. technical staff.
• The equipment is used by qualied staff and in accordance
with the recommendations in this Instruction Manual.

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1.4. LAYOUT OF CONTROLS, INDICATORS AND
CONNECTORS
FRONT PANEL
2
1
3
45678 9 10 11 12
13 14
15
16 17 18 19

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1- Display.
2- Doctor's microphone.
3- Attenuators: to increase or decrease the signal level applied
to the patient (dBs) and select the menu options.
4- Reset: deletes certain information.
5- Sisi: generates the manual increments for the SISI test.
6- Print: prints the audiometric le which has been created,
if thresholds have previously been saved.
7- F1: selects the conduction route for the application of the
signal.
8- F2: selects the signal source.
9- F3: selects the signal presentation mode.
10- Menu: provides access to the various options.
11- Database: saves a test in the database.
12- Intercom: activates the intercom.
13- Invert: inverts the "direct/inverted" operation of the
SIGNAL keys (no. 16 and 19).
14- Patient: enables entry of a patient reference for a test to
be printed, saved in the internal database or transferred
to a database on a PC.
15- Enter: used to save the thresholds recorded in a test or
to conrm information entered or selected.
16- Right hand channel signal: silencer or key - transmits or
blocks the signal to the patient when pressed, depending
on whether "direct" or "inverted" mode has been selected.
17- Decreases the frequency of the pure-tone signal applied
to the patient.
18- Increases the frequency of the pure-tone signal applied
to the patient.
19- Left hand channel signal (idem right channel).

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REAR PANEL
14
15
16
13 12 11
10 976
21
3
5
8
4
16 17
2XF 1.6A H 250V

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1- Bone Conduction
2- Air Conduction
3- High Frequency Air Conduction
4- Patient Microphone
5- Doctor's Microphone
6- Patient response button
7- Free eld
8- Auxiliary input
9- Intercom headset
10- Parallel printer
11- RS·232·C connection
12- USB – PC connection
13- USB connection – Printer
14- Terminal for mains earth connection
15- POWER input 100V - 240V
16- Fuse holder
NOTE: The 2 fuses used are 1.6A, fast (F), and high
cutting capacity (H).
17- On/off switch
NOTE: According to the EN60601-1 standard, the switch
isolates both phases at the same time isolating the
electric current when the equipment is off.