Interacoustics Callisto AC440 Instructions For Use Manual page 8

NOTICE
D-0101246-M – 2020/05
Callisto™ - Instructions for Use - US
When using insert ear phones, make sure that foam or ear-tip is mounted
correctly.
It is recommended that the disposable foam ear-tips supplied with the optional
IP30, E.A.R Tone 3A or E.A.R Tone 5A insert transducers are replaced after
each client tested. Disposable plugs also insure that sanitary conditions exist for
each of your clients.
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 appropriated level of cleanliness.
The transducers (headphones, bone conductor, etc.) supplied with the
instrument are calibrated to this instrument - exchange of transducers requires
a new calibration.
Interacoustics will not make any guarantee to the functionality of the system if
any other software is installed, with exception of the Interacoustics
measurement (AC440/REM440) modules and AuditBase system4, OtoAccess®
or a Noahcompatible Office Systems or later releases.
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.
The instrument is intended for continued use. However, there is a risk of
damaging the transducers if they are operated at the highest intensities for
longer periods.
The transducers (headphones etc.) supplied with the instrument are calibrated
to this instrument - exchange of transducers requires a new calibration.
No installation precautions are necessary to avoid unwanted sound radiation
from the audiometer.
There is no warm-up time for the instrument, but allow it to become
acclimatised before use.
Be sure to use only stimulation intensities, which will be acceptable for the
patient.
The reference and the probe microphones can be verified using the procedures
described in calibration software.
Within the European Union it is illegal to dispose of electrical and electronic
waste as unsorted municipal waste. Electrical and electronic waste may contain
hazardous substances and therefore have to be disposed of separately. Such
products will be marked with the crossed-out wheelie-bin image shown to the
left. User cooperation is important in order to ensure a high level of reuse and
recycling of electrical and electronic waste. Failure to recycle such waste
products in an appropriate way may endanger the environment and
consequently the health of human beings.
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