Surface Heating of Invasive Transducers
The average and peak radiated acoustic powers of all [Company] transducers are limited by detection circuitry, to insure that the surface heating of the transducer array is less than 43ºC.
To limit the average acoustic power output, the maximum pulse repetition frequency (PRF) is tested in hardware by comparing a PRF counter to a preset value. Exceeding the maximum allowable PRF triggers an error message that displays on the host computer, and the [Company] Ultrasound System acoustic output is disabled. The preset maximum PRF is chosen to limit the transducer case temperature to less than 43ºC.
The peak acoustic power is constrained by the maximum voltage applied to the transducer-array elements. In hardware, peak power is monitored by a watchdog device that measures instantaneous power and compares it to two thresholds. The first threshold is a non-programmable four-watt limit. The second threshold is a programmable limit that [Company] has set in accordance with IEC 60601-2-37 and AIUM Nema UD2 and UD3 (1998 and 2004).
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