Interacoustics ASSR Instrucciones De Uso página 5

Date: 2009-09-01
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.
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.
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:
All manuals and user guides at all-guides.com
ASSR Instructions for Use – English
Precautions
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