Interacoustics Callisto Gebrauchsanweisung Seite 8

Callisto™ Instruction for Use -GB
Page 4
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 guaranty 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 Noah3.7.
compatible 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.
Only recorded speech material with a stated relationship with the calibration signal
should be used. In the calibration of the instrument it is assumed that the
calibration signal level is equal to the average level for the speech material. If this is
not the case, the calibration of the sound pressure levels will be invalid and the
instrument needs recalibration.
To establish conformity with the IEC 60645-2 standard, it is important that the
speech input level is adjusted to 0VU. It is equally important that any free field
installation is calibrated at the site where it is used and under the conditions that
exists during normal operation.