Inventis TRIANGLE Manual página 11

the device to a soundproof booth, check that the sockets are
compatible with the specifications prescribed for each connector.
Use only the medical grade power adapter supplied with the device,
IEC 60601-1 certified. For further information see Appendix A.
Triangle is a medical device: if connected to a computer (or any
external device) located within the "patient area" (as defined in IEC
60601-1), this likewise must be a medical device, or protected by an
isolating transformer, in order to ensure that the combination of
computer (external device) + audiometer is in compliance with IEC
60601-1.
Triangle must be installed and operated taking into account the
information regarding electromagnetic compatibility (EMC)
provided in Appendix C.
Avoid installing and using the device near sources of strong
electromagnetic fields, which could interfere with the equipment's
operation.
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.
1.5.2 Calibration
The calibration is valid for transducers supplied with the equipment,
if connected directly to the device without any interposition of
extension leads or other connectors (e.g. when connected to a
soundproof booth). If a transducer is replaced or not connected
directly to the device, a new calibration is required before using the
device.
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 non-calibrated transducers.
Take note of the calibration interval indicated. Use of the device
after the calibration expiration can lead to unreliable diagnoses.
EN
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