Inventis TIMPANI Manual Del Usuario página 12

The Timpani is a medical device: if connected to a computer (or any
external device) located within the "patient area" (as defined in IEC
60601-1-1), this likewise must be a medical device, or protected by an
isolating transformer, in order to ensure that the combination of
computer (external device) + tympanometer is in compliance with IEC
60601-1-1 standard.
The Timpani tympanometer can be used in conjunction with a
soundproof booth to conduct tests under optimum acoustic conditions.
Before connecting the instrument to a soundproof booth, check that
the sockets are compatible with the specifications prescribed for each
connector.
The Timpani must be installed and operated taking account of the
information
provided in Appendix C.
The proximity of portable and mobile appliances used for RF
communications can affect the operational efficiency of the
instrument box. Refer to the information regarding electromagnetic
compatibility (EMC) provided in Appendix C.
1.7.2 Calibration
The calibration of the instrument is dependable only for the
transducers supplied. If a transducer is replaced, the instrument must
be recalibrated.
The calibration is dependable for transducers supplied with the
equipment, if connected directly to the instrument, without any
interposition of extension leads and without the passage from
connectors to panel (as habitually occurs in soundproof booth
installations). If the transducers are not connected directly to the
device, a new calibration procedure will be required before the
instrument is used.
If the transducer selected is not calibrated, an alert will appear in the
test screens. It will not be possible to present any stimulus to the
patient using transducers that have not been calibrated.
Take note of the calibration interval indicated. Use of the instrument
beyond the calibration interval expiry date can lead to unreliable
diagnoses.
1.7.3 Hygiene
The earpieces of the tympanometer probes are disposable; do not use
the same earpiece for different patients. Dispose of earpieces after
use.
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regarding electromagnetic compatibility (EMC)