Interacoustics ASSR Bedienungsanleitung

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

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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 

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



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:

Power

Turns power on/off

Mains 50-60 Hz

Plug for mains cable

Aux Out

For future use

Preamp.

Plug for preamplifier

Pat. Resp.

Plug for patient response knob

Trigger In/Out

Connector for trigger input/output

Talk Back

Connector for talk back microphone

Talk Forward

Connector for talk forward microphone

OAE

Plug for the eight pin OAE probe

Left

Plug for left phone

Right

Plug for right phone

Bone

Plug for bone conductor

USB/PC

Plug for USB cable or PC

Plug for power supply for optical USB extension cable

Connection for functional ground

Explanation to symbols which can be found on the instrument:

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)

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