Interacoustics Affinity 2.0 Manual De Instrucciones página 4

Affinity
2.0
may be used for analyzing hearing aids‟ acoustic performance in the manufacturing or fitting
The Affinity
situation.
It may also be used to do audiometry and various acoustic demonstration tasks in the sales process.
Warning – Interacoustics will not make any guaranty to the functionality of the system if any other software is
installed, with exception of the Interacoustics measurement (HIT440/AC440/REM440) modules and a NOAH3 or a
NOAH3 compatible Office System.
Notice - The specification for the instrument is valid if the instrument is operated within the following
environmental limits:
Temperature: 15°C to 35 °C.
Humidity: 30 %RH to 90 %RH
Supply voltage:100 – 240 Vac
Supply frequency: 50 – 60 Hz
Notice - The instrument must warm up for at least 1 minute before use.
Notice - The reference and the probe microphones can be verified using the procedures described in calibration
software.
Notice - Be sure to insert the probe tip in a way, which will assure an air tight fit without causing any harm to the
patient. Using a proper and clean ear tip is mandatory.
Notice - We recommend using a new ear tip for each patient.
If the clinician rinses the ear tips they should be subjected to standard disinfecting procedure between patients.
This includes physically cleaning the ear tip and use of a recognised disinfectant. Individual manufacturer's
instruction should be followed for use of this disinfecting agent to provide an appropriated level of cleanliness.
Notice - Be sure to use only stimulation intensities, which will be acceptable for the patient.
Notice - The transducers (headphones, bone conductor, etc.) supplied with the instrument are calibrated to this
instrument - exchange of transducers require a re-calibration.
Notice - 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
recognised disinfectant. Individual manufacturer's instruction should be followed for use of this disinfecting agent
to provide an appropriated level of cleanliness.
Notice - Please note that the CE Marking is only legal if this Instruction is translated into the national language of
the user no later than at the delivery to him, if the national legislation demands a text in the national language
according to MDD article 4.4.
Notice - 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.
Although the instrument fulfills the relevant EMC requirements precautions should be taken to
Notice:
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.
Notice – No installation precautions are necessary to avoid unwanted sound radiation from the audiometer.
If this apparatus 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.
2.0
Instruction for Use - English
Date: 2008-10-03
Intended Use
Precautions
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