Interacoustics ASSR Instructions For Use Manual

Instructions for Use

Interacoustics ASSR

- for the Eclipse

Valid from software version 1.00

80701304 -10/2010

Instructions for Use  GB

Manual de instrucciones  ES

Instrucções para a utilização  PT

   GR

Brugsanvisning  DK

Gebruiksaanwijzing  NL

 PL

 IT

Gebrauchsanweisung  DE

 FR

Bruksanvisning  SE

Upute za uporabu  HR

Navadila za uporabo  SL

Instructiuni de utilizare - RO

Bruksanvisning  S

Instructions for Use - GB

Interacoustics ASSR

- for the Eclipse

Valid from software version 1.00

ASSR Instructions for Use  English

Date: 2009-09-01 Page 1/10

Intended use of the Interacoustics ASSR

The Interacoustics ASSR is indicated for use in the recording and analysis of human physiological data

used for the diagnosis of auditory and hearing-related disorders.

This product, Interacoustics ASSR is a diagnostic device intended to be used as part of a set of

audiometric test protocols. It is especially indicated for use in defining the configuration of the hearing

loss particularly for individuals whose behavioral audiometric results are deemed unreliable. It allows

for the estimation of hearing threshold at various frequencies, through the use of ASSR (Auditory

Steady-State Response) test protocols. It is designed to be used as a diagnostic test procedure by

individuals who are trained in the performance and interpretation of evoked potentials such as

audiologists and physicians. The results of the test will be used by trained hearing health care

professionals to make recommendations regarding appropriate intervention strategies.

The use of the Interacoustics ASSR is to be performed under the prescription and supervision of a

physician or other trained health care professional.

The patient group includes all ages and sexes.

Precautions

1. Be sure to use only stimulation intensities, which will be acceptable for the patient.

2. The transducers (headphones, bone conductor, etc.) supplied with the device are calibrated to

this device - exchange of transducers require a new calibration.

3. It is recommended that parts which are in direct contact with the patient (e.g. earphone

cushions) are subjected to standard disinfecting procedure between patients. This includes

physically cleaning and use of a recognized disinfectant. Individual manufacturer's instruction

should be followed for use of this disinfecting agent to provide an appropriate level of

cleanliness.

4. Please note that if connection is made to standard equipment like printers and network, special

precautions must be taken in order to maintain medical safety. Optical isolation unit for USB is

available from your supplier.

5. Although the instrument fulfils the relevant EMC requirements precautions should be taken to

avoid unnecessary exposure to electromagnetic fields, e.g. from mobile phones etc. If the

device is used adjacent to other equipment it must be observed that no mutual disturbance

appears.

6. The specification for the instrument is valid if the instrument is operated within the following

environmental limits:

WARNING indicates a hazardous situation which, if not avoided, could

result in death or serious injury.

CAUTION, used with the safety alert symbol, indicates a hazardous

situation which, if not avoided, could result in minor or moderate injury.

NOTICE is used to address practices not related to personal injury.

ASSR Instructions for Use  English

Date: 2009-09-01 Page 2/10

Temperature: 15°C to 35 °C.

Humidity: 30 %RH to 90 %RH

Supply voltage:100  240 Vac

Supply frequency: 50  60 Hz

If this device is connected to one or more other devices with medical CE marking, to

make up a system or pack, the CE marking is only valid also for the combination if the

supplier has issued a declaration stating that the requirements in the Medical Device

Directive article 12 are fulfilled for the combination.

ASSR Instructions for Use  English

Date: 2009-09-01 Page 3/10

Operation Instruction

Preparations prior to the ASSR Test

For obtaining reliable and valid test results it is most important that the patient is well prepared for the

test.

Preparation of the Skin

It is very important to clean the skin where the electrodes are to be placed in order to obtain an

acceptable low skin impedance.

1. Clean the skin thoroughly with the skin preparation gel.

2. Wash off the gel with alcohol before applying the electrodes.

Placement of Electrodes

Place an electrode on each mastoid or earlobe, one at vertex (or hair-line) (for white connector) and

one on the cheek (for black connector). Connect all four electrode leads.

Insertion of the insert earphones

Make sure that the end of the black tube is not occluded by the yellow foam when you roll the insert

earphone tip into the smallest diameter possible.

Insert the tip well into the ear canal. The correct insertion depth into the ear canal is obtained when the

rear edge of the insert earphone is 1-2 mm inside the entrance of the ear canal.

Hold the insert earphone in the ear canal until expanded.

Use a new pair of ear tips for each patient.

Impedance Check

After having attached the electrodes to the patient it is crucial to check the skin impedance. For best

results, impedance at each electrode should be as low as possible, preferably 3 k or less.

Return to ERA mode by clicking IMP button.

ASSR Instructions for Use  English

Date: 2009-09-01 Page 4/10

Quick Guide

The Quick Guide describes a typical examination using one of the preset protocols.

Starting OtoAccess: ASSR

1. Switch on your ASSR workstation and wait for windows® to start.

2. Double 

1

Icon

3. Choose an existing client (or enter and save a new client)

4. Double click on the ASSR icon .

Performing an ASSR measurement

1. Prepare the patienence for Preparing the Patien

2. Select desired ASSR test protocol. ex.

3. If needed, adjust the rejection level to have a large size EEG displayed, but without the EEG

changing to red. Settings higher than 20 µV indicates a less than ideally relaxed patient (or electrical

noise interference), and less than perfect recording results are thus to be

expected. 80 µV or higher will not provide optimum results.

4. Click on the Start button to begin the ASSR test.

5. As results are obtained, additional test intensities can be selected by

right clicking within the desired frequency pane.

6. When the test is completed it is possible to:

Provide an Estimated Audiogram



applying a different correction table or by manually dragging audiogram points

with the mouse.

Print the examination

Click on the print button in the toolbar or choose Print under the File menu.

Creating a Report

Select the Report button . Select a report template. Modify text if needed.

Save and Exit

Click on the save and exit button in the toolbar.

Helpful tools:

Temporary change to Auto Test: Prior to starting a test, the default selection of frequenencies to be

he upper left hand corner of the recording screen.

Temporary Setup disable or enable frequencies, change intensities, adjust parameters to patient

arousal state etc, temporarily for this session. Changes are effective in the current session only, and

will NOT permanently change the test protocol.

ASSR Instructions for Use  English

Date: 2009-09-01 Page 5/10

O



Browse between historical sessions: use the PgUp and PgDn keys to toggle between historical

sessions.

Additional controls during testing : Right click in desired frequency pane, to be able to select

extension of test time or to stop an ongoing test on that frequency.

Connection Panel Eclipse

Position:

Symbol:

Function:

1

Power

Turns power on/off

2

Mains 50-60 Hz

Plug for mains cable

3

Aux Out

For future use

4

Preamp.

Plug for preamplifier

5

Pat. Resp.

Plug for patient response knob

6

Trigger In/Out

Connector for trigger input/output

7

Talk Back

Connector for talk back microphone

8

Talk Forward

Connector for talk forward microphone

9

OAE

Plug for the eight pin OAE probe

10

Left

Plug for left phone

11

Right

Plug for right phone

12

Bone

Plug for bone conductor

13

USB/PC

Plug for USB cable or PC

14

DC

Plug for power supply for optical USB extension cable

15

Connection for functional ground

Explanation to symbols which can be found on the instrument:

I

On (Power: connection to the mains)

Off (Power: disconnection from the mains)

Ground

!

See explanation in manual

Type BF equipment

ASSR Instructions for Use  English

Date: 2009-09-01 Page 6/10

Technical Specifications

The technical specifications provided here cover the general aspects of the instrument, while more

specific details can be found in the Operation Manual in english.

Standards:

IEC 60601-1 (General safety) Class I, Type BF

IEC 60601-1-1 (Safety of systems) Class I, Type BF

IEC 60601-1-2 (EMC)

IEC 60601-2-26 (Electroencephalographs)

IEC 60645-1/ANSI S3.6 (Audiometers)

IEC 60645-3 (Auditory test signals)

Medical CE-mark:

Interacoustics A/S meets the requirements of Annex II of the Medical Device Directive 93/42/EEC.

Approval of the quality system is made by TÜV  identification no. 0123.

PC Requirements (PC not included):

Operating System: Windows XP©, Windows 98se, Windows 2000, Vista

Processor: Pentium III, 800Mhz or better

RAM: 256MB

Hard disk: 1GB

Display Resolution: 1024 x 768 or better

USB: 1.1 or higher

System:

Eclipse Black box to connect to your own PC

Safety:

Medical Safety transformer built-in

Optical isolation to PreAmplifier

Optical USB Isolation to PC (optional)

PreAmplifier:

2 channels.

Gain: 80 dB/60 dB.

Frequency Response: 0.5-5 k Hz

Noise:4 22µV RMS (0-3kHz))

CMR ratio: Minimum >118 dB. Typical 130 dB <100 Hz



Power: From main unit

Anti Aliasing Filter:

Analogue 5kHz 24dB / octave (30kHz Sampling rate)

ASSR Instructions for Use  English

Date: 2009-09-01 Page 7/10

Impedance Check:

33Hz rectangle.

Impedance information for each individual electrode.

No unplugging of electrode leads required.

Readout directly on Amplifier.

Measuring Current: 19uA.

-

Transducers:

Ear-Tone ABR insert phones included.

Independent calibration for TDH39 (TDH29 not included).

Number of Channels:

2 channel response detection. (EPA3: 1 channel).

8 channels for stimulus control

Test Protocols:

Test protocols included for children and for awake adults.

Customized protocols can be created by user.

Stimuli:

500Hz, 1kHz, 2kHz, 4kHz

Bandwidth: +/- ½ octave -3dB. Very steep roll offs.

Compensation for cochlear delays

Simultaneous stimuli: 8 (4 frequencies in each Ear)

Modulation Rates:

90Hz and 40Hz.

Can be changed within the same session.

Masking:

White noise

0  100dB HL

Stimulus Control:

Independent control of up to 8 simultaneous stimuli (max. 4 per ear).

Independent stimulus level control for each of the 8 stimuli, with dynamic range assistance

Independent start / stop control for each of the 8 stimuli

Data Acquisition:

2 channels

Separate Detection Algorithm for each Channel

A/D resolution: 16bit

Manual Start and Stop: Global as well as for each Stimulus

Time out limits:

Max 15min. (Default: 6min.)

Manual change in +/- 1 min. steps.

False Pass Probability Settings: 1% and 5%

ASSR Instructions for Use  English

Date: 2009-09-01 Page 8/10

Gain:

Manual: 6dB steps from 74dB to 110dB (5µV to 3200µV input).

Rejection system:

Manual increase and decrease of rejection limits during data acquisition.

Raw EEG:

Online display for each channel simultaneously.

Refresh rate: 10Hz typical.

Printout:

Customized printouts.

Hardcopy or as pdf file for EMR

Patient communication:

Talk back (built in loudspeaker).

OtoAccess Database:

Included

Database: SQL

Data format: XML

Unlimited storage. Patient Journal.



analyzers.

Easy back-up function.

Interacoustics ASSR may alternatively run without a database.

NOAH:

NOAH compatible (NOAH 3.6 or higher)

(Estimated Audiogram available for other NOAH modules)

Networks:

May connect to a network.

Subsequent sessions viewing from reader stations.

With optional software, even tests in progress may be monitored and controlled from any reader

station in the network.

Dimensions:

Eclipse: (L x W x H) 28 x 32 x 5,5 cm / 11 x 12.5 x 6 inches.

Weight:

Eclipse: 2,5 kg / 5,5 lbs excluding accessories

Other modules available for the Eclipse black box:



ening (ABRIS)





ASSR Instructions for Use  English

Date: 2009-09-01 Page 9/10

Detachable Parts

Included Parts (Complete System):

 ECLIPSE

 EPA Preamplifier

 ETB Standard electrode cable with buttons

 ETU Universal electrode cable

 ETR Electrode cable with re-usable electrodes

 PEG15 Set of 25 single use pre-gelled

electrodes

 20 pcs. of Infant eartip (2 x 10)

 EarTone ABR Insert ear phones w/foam tips

 SPG15 Tube of skin preparation gel

 Electrode gel

 Alcohol pads (100 pcs.)

 USB cable 2m

 Power cable

 Software CD

 Database Software

 Operation Manual

 CE Manual

Optional Parts:

 TDH39 Headset

 UCO15 Optical USB extension cable for Eclipse

Black Box (can be delivered with 1 or 5 metres

USB cable).

Concerning Repair

1. Interacoustics is only considered to be responsible for the validity of the CE marking, effects on

safety, reliability and performance of the equipment if:

assembly operations, extensions, readjustments, modifications or repairs are carried out

by authorized persons,

a 1 year service interval is maintained

the electrical installation of the relevant room complies with the appropriate requirements,

and

the equipment is used by authorized personnel in accordance with the documentation

supplied by Interacoustics.

2. Should a problem with the device arise, please contact your local distributor. The RETURN

REPORT located in the back of the operational manual must also be sent to Interacoustics,

Drejervanget 8, DK-5610 Assens in connection with reporting of problems, incidents, etc.

3. When instrument fuses need renewal, the correct type as stated on the instrument shall be used.

ASSR Instructions for Use  English

Date: 2009-09-01 Page 10/10

General Maintenance Procedures

The performance and safety of the instrument will be kept if the following recommendations for care

and maintenance are observed:

It is recommended to let the instrument go through at least one annual evaluation, to ensure that the

acoustical, electrical and mechanical properties are correct. This should be made by an experienced

workshop in order to guarantee proper service and repair.

Before the connection to the mains, be sure that the local mains voltage corresponds to the voltage

labelled on the instrument.

Observe that no damage is present on the insulation of the mains cable or the connectors and that it is

not exposed to any kind of mechanical load, which could involve damage.

For maximum electrical safety, turn off the power from a mains powered instrument when it is left

unused.

Do not place the instrument next to a heat source of any kind, and allow sufficient space around the

instrument to ensure proper ventilation.

To ensure the reliability of the instrument, periodic biological measurements should be performed on a

person with known data. This person could be the operator him/herself.

If the surface of the instrument or parts of it is dirty, it can be cleaned using a soft cloth moistened with

a mild solution of water and dish washing cleaner or similar. The use of organic solvents and aromatic

oils must be avoided. Always disconnect the mains plug during the cleaning process, and be careful

that no fluid is entering the inside of the instrument or the accessories.

After each examination of a patient, proper cleaning must ensure that there is no contamination on the

parts in connection with patients. General precautions must be observed to prevent transmission of

disease from one patient to another. If the ear cushions or ear tips are contaminated, it is strongly

recommended to remove them from the transducer before they are cleaned. Frequent cleaning using

water may be used, but periodic use of a mild disinfectant may also be used. The use of organic

solvents and aromatic oils must be avoided.

Great care should be exercised by the handling of earphones and other transducers, as mechanical

shock may cause change of calibration.

Instrucciones de uso - ES

Interacoustics ASSR

- para Eclipse

Válido a partir de la versión de software 1.00

Instrucciones de uso de ASSR - Español

Fecha: 2009-09-01 Rev.: Página 1/10

Aplicación de ASSR Interacoustics

ASSR Interacoustics está indicado para usarse en el registro y análisis de datos psicológicos humanos

para el diagnóstico de trastornos auditivos y relacionados con el oído.

Este producto, Interacoustics ASSR, es un dispositivo de diagnóstico previsto para formar parte de un

conjunto de protocolos de pruebas audiométricas. Su uso está especialmente indicado para definir la

configuración de pérdida de capacidad auditiva, en concreto la de aquellas personas cuyos resultados

audiométricos de conducta se estimen poco fiables. Permite la estimación del umbral de audición a

diversas frecuencias, mediante el empleo de protocolos de pruebas ASSR (respuestas auditivas de

estado estable). Está diseñado para que lo utilicen personas con la preparación adecuada que sepan

obtener e interpretar potenciales evocados, como audiólogos y médicos. Los resultados de la prueba

serán examinados por profesionales sanitarios especializados en audición que deberán recomendar

las estrategias de intervención pertinentes.

El empleo de ASSR Interacoustics debe realizarse bajo la prescripción y supervisión de un médico u

otro profesional sanitario con la formación apropiada.

El grupo de pacientes abarca todas las edades y ambos sexos.

Precauciones

1. cerciorarse de usar solamente intensidades de estimulación que sean aceptables para el

paciente

2. los transductores (auriculares, conductores óseos, etc.) suministrados con el dispositivo van

calibrados para dicho dispositivo; si se cambian los transductores, hará falta una nueva

calibración.

3. se recomienda someter al procedimiento habitual de desinfección entre pacientes las piezas

que estén en contacto directo con el paciente (ej., almohadillas de los auriculares). Dicho

procedimiento incluye la limpieza física y empleo de un desinfectante homologado. Al usar

dicho producto desinfectante, deben seguirse las instrucciones del fabricante para garantizar

un nivel de limpieza apropiado.

4. téngase en cuenta que si el dispositivo se conecta a equipos habituales, como impresoras o

redes, deben tomarse precauciones especiales con el fin de mantener la seguridad médica.

Su proveedor puede ofrecerle una unidad de aislamiento óptico para USB.

5. aunque el instrumento cumple los requisitos de compatibilidad electromagnética (CEM),

deben tomarse precauciones para evitar una exposición innecesaria a campos

electromagnéticos, p. ej., de teléfonos móviles, etc. Si se pone el dispositivo junto a otro

aparato, hay que asegurarse de que no se perturben mutuamente.

ADVERTENCIA indica una situación peligrosa que, de no evitarse,

podría ocasionar heridas graves o muerte.

PRECAUCIÓN, utilizado junto con el símbolo de alerta de seguridad,

indica una situación peligrosa que, de no evitarse, podría ocasionar

heridas leves o moderadas.

AVISO se utiliza para hacer referencia a prácticas que no ocasionan

lesiones personales.

Instrucciones de uso de ASSR - Español

Fecha: 2009-09-01 Rev.: Página 2/10

6. Las características del equipo son válidas sólo en el caso de que el equipo funcione bajo los

siguientes límites ambientales:

Temperatura: 15°C a 35°C.

Humedad: 30% RH a 90% RH

Voltaje de alimentación: 100  240 Vac

Frecuencia de alimentación: 50  60 Hz

Si este aparato se conecta a uno o varios dispositivos con el marcado CE médico para

componer un sistema o paquete, el marcado CE sólo será válido para esa

combinación si el proveedor ha proporcionado una declaración que constate que dicha

combinación cumple el artículo 12 de la Directiva sobre dispositivos médicos.

Instrucciones de uso de ASSR - Español

Fecha: 2009-09-01 Rev.: Página 3/10

Instrucciones de funcionamiento

Preparativos previos para la prueba ASSR

Con el fin de obtener unos resultados válidos y fiables, es de suma importancia que el paciente esté

bien preparado para la prueba.

Preparación de la piel

Es muy importante limpiar la piel donde se vayan a colocar los electrodos a fin de conseguir una

impedancia baja de la piel aceptable.

3. Limpie la piel a conciencia con el gel de preparación.

4. Lave el gel con alcohol antes de colocar los electrodos.

Colocación de los electrodos

Ponga un electrodo en cada mastoides o lóbulo de oreja, uno en el vértice (o nacimiento del pelo)

(para el conector blanco) y otro en la mejilla (para el conector negro). Conecte los cuatro cables de los

electrodos.

Colocación de los auriculares de inserción

Asegúrese de que el extremo del tubo negro no quede concluido por la espuma amarilla al introducir la

punta del auricular de inserción hasta el diámetro mínimo posible.

Introduzca bien la punta en el canal auditivo. Se alcanza la profundidad correcta de inserción en el

canal auditivo cuando el borde trasero del auricular de inserción está 1-2 mm dentro de la entrada de

dicho canal.

Mantenga la auricular de inserción en el canal auditivo hasta que se expanda.

Use un par de puntas nuevas para cada paciente.

Comprobación de impedancia

Una vez fijados los electrodos al paciente, es fundamental comprobar la impedancia de la piel. Para

obtener los mejores resultados, la impedancia de cada electrodo debe ser lo más baja posible,

preferiblemenenos.

Para volver a ERA haga clic en el icono IMP.

Instrucciones de uso de ASSR - Español

Fecha: 2009-09-01 Rev.: Página 4/10

Guía rápida

La guía rápida describe un examen típico usando uno de los protocolos preestablecidos.

Iniciar OtoAccess: ASSR

1. encienda su estación de trabajo ASSR y espere a que se inicie Windows®.

2. Haga doble clic en el icono 

2

3. Seleccione un cliente existente (o introduzca y guarde un cliente nuevo).

4. Haga doble clic en el icono de ASSR.

Realizar una medición ASSR

1. Prepare al pacienencia rápida para preparar al pacien

2. Seleccione el protocolo de prueba ASSR deseado. Ej.

3. Si fuera necesario, ajuste el nivel de rechazo para que aparezca un EEG de tamaño grande, pero

sin que el EEG se ponga rojo. Los valores por encima de 20 µV indican un paciente menos relajado

de lo que sería ideal (interferencia de ruido eléctrico) por lo que han de

esperarse unos resultados de registro menos que perfectos. Con 80 µV

o más no se conseguirán resultados óptimos.

4. Haga clic en el botón Start (inicio) para comenzar la prueba ASSR.

5. A medida que se obtienen los resultados, pueden seleccionarse otras

intensidades para la prueba haciendo clic en el panel de frecuencia

0deseado.

6. Una vez terminada la prueba, se puede:

Obtener un audiograma estimado



pueden hacerse cambios aplicando una tabla de corrección distinta o arrastrando

manualmente con el ratón puntos de audiograma.

Imprimir el examen

Haga clic en el botón de impresión de la barra de herramientas o seleccione Print (Imprimir) en el

menú File.

Crear un informe

Seleccione el botón de informe. Seleccione una plantilla. Modifique el texto si es necesario.

Guardar y salir

Haga clic en el botón de guardar y salir de la barra de herramientas.

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Interacoustics ASSR Instructions For Use Manual

Interacoustics ASSR Instructions For Use Manual

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