Ulthera DeepSEE DS 4 - 4.5, Instructions For Use Manual

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Ulthera, Inc. Page
25
Measurement uncertainty for power, pressure, intensity, and other quantities
that are used to derive the values in the acoustic output table were derived
in accordance with Section 6.4 of the Output Display Standard and were
below limits which would affect global output levels. The measurement
uncertainty values were determined by making repeat measurements.
Table 4.3 Acoustic Measurement Precision and Uncertainty
PARAMETER
UNCERTAINTY
(95% CONFIDENCE)
Pr 14.5%
Pr
.3
14.5%
Wo 29%
Fc 2%
PI I 29%
PI I
.3
29%
4.4.3. References
•
[1] Medical Ultrasound Safety, American Institute of Ultrasound in
Medicine (AIUM), 1994.
•
[2] Acoustic Output Measurement Standard for Diagnostic Ultrasound
Equipment, NEMA UD2-2004.
• [3] Standard for Real-Time Display of Thermal and Mechanical Acoustic
Output Indices on Diagnostic Ultrasound Equipment, American Institute of
Ultrasound in Medicine, 2004a.
•
[4] Acoustic Output Labeling Standard for Diagnostic Ultrasound
Equipment, American Institute of Ultrasound in Medicine, 2008.
•
[5] Information for Manufacturers Seeking Marketing Clearance of
Diagnostic Ultrasound Systems and Transducers, FDA, 2008.
4.5. Electromagnetic Compatibility and Immunity
The Ulthera System’s RF emissions are very low and are not likely to cause
interference in nearby electronic equipment.
Ulthera is suitable for use in all establishments other than domestic and those
directly connected to the public low voltage power supply network that
supplies buildings used for domestic purposes.
Mains (AC) power quality should be that of a typical commercial or hospital
environment.