56
Initial setting range
of sound output
10% to 100%
The maximum acoustic output limit depending on the selected mode of the probe surface
temperature rise and the provisions of the FDA acoustic output of each probe.
Be
careful
When you turn on the scanner, change transducer, set a new patient, the
system settings will be the default ones.. The user in accordance with the
principle of ALARA and meet the FDA 510 (k) Guidance-Track3 limits, the
user can through the corresponding increase in the sound power soft menu
you can also set the AP value in the preset level.
The sound output system is based on EN 60601-2-37:2008+A1:2015, FDA 510 (K)
GUIDANCE, the diagnostic ultrasound equipment acoustic output measurement standard
(NEMA UD-2 2004) , diagnostic ultrasound equipment thermal and mechanical index real-
time display standard (AIUM and NEMA UD-3 2004) were measured and calculated. For
a definition of terms used in the acoustical output tables, see Appendix C.
9.6
Acoustic power control
Sound output depends on the system operator, the operator should obtain qualified under
the premise of effective diagnostic image to reduce the acoustic output. There are three
types of operation control and sound output control: direct control and indirect control and
receiver control.
⚫
Direct control
The system of direct control of acoustic output through the soft menu area [] sound power
project adjusting acoustic output size. But in any mode of the acoustic output maximum
value can not exceed the acoustic output limit (MI limit of 2 TI, the limit value is 6, ISPTA.3
limit of 720 mW/cm
2
).
⚫
Indirect control
Indirect control of acoustic output is mainly caused by the control of image related
parameters. These include control operation mode, probe and frequency, focus, depth
image and pulse repetition frequency (PRF).
The operating mode determines the ultrasonic beam is scanning and non scanning mode,
the thermal effect with M, Doppler, Color are closely related.
The attenuation of the tissue is directly related to the change of the probe and its frequency.
The image depth is related to the effective aperture of the probe.
⚫
Receiver control
