D-0101246-Q – 2022/05
Callisto™ Instructions for Use - US Page 6
calibration signal level is equal to the average level f or 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.
Great care should be exercised by the handling of earphones and other
transducers, as mechanical shock may cause change of calibration.
The specif ication for the instrument is valid if the instrument is operated within
the environmental limits specif ied in technical specif ications.
Supply voltage: USB-powered (USB Type B connector).
To prevent system faults, take appropriate precautions to avoid PC viruses and
similar.
Using operating systems where Microsoft have discontinued sof tware and
security support will increase the risk f or viruses and malware, which may result
in breakdowns, data loss and data thef t and misuse.
Interacoustics A/S cannot be held liable f or your data. Some Interacoustics A/S
products support or may work with operating systems unsupported by
Microsoft. Interacoustics A/S recommends you to always use Microsoft
supported operating systems that are kept f ully security updated.
1.6 Malfunction
In the event of a product malfunction, it is important to protect patients, users, and other
persons against harm. Therefore, if the product has caused, or potentially could cause such
harm, it must be quarantined immediately.
Both harmf ul and harmless malfunctions, related to the product itself or to its use, must
immediately be reported to the distributor where the product was acquired. Please remember to
include as many details as possible e.g., the type of harm, serial number of the product,
sof tware version, connected accessories and any other relevant inf ormation.
In case of death or serious incident in relation to the use of the device, the incident must
immediately be reported to Interacoustics and the local national competent authority.
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