Ch 7 Performance & Safety Flashcards
No confirmed adverse effect in mammals exposed in vivo:
Below 1 W/cm2 SPTA
W/ low megahertz range
And
Focused beam
Typical output intensity (SPTA) for US
1 mW/cm2
Hydrophone membrane made of
Polyvinylidene fluoride (PVDF)
Temp rises significant if
Exceed 2 degrees C
Tissue phantoms simulate tissue properties and assess:
Detail/contrast resolution, penetration, dynamic range, and TGC
Tissues w/ well-defined gas (like lungs) have been observed for in situ peak rare factional pressures
Below 0.4 MPa or MI less than 0.4
Highest acoustic pressure output
Spectral Doppler
Lowest outputs
Gray-scale
Attenuation due to
Absorption (conversion of US to heat)
Test objects contain _____ and ______ to evaluate _______ and ________. They do not _______.
Nylon lines; scattering layers
Detail resolution; beam profiles
Simulate tissue characteristics
Regular quality control testing required by ___ at a minimum _____.
ACR
Semiannually
Bio effects have not occurred below ___. Above that bio effects depend on ___and ___.
39*C
Temp, time
Temp increases in tissues close to transducer surface significantly caused by
Transducer self-heating
Bio effects of hyperthermia:
Fetal absorption/abortion, IUGR, microphthalmia, cataract production, abdominal wall defects, renal agenesis, palatal defects, reduced brain waves, microencephaly, anencephaly, spinal cord defects, renal amyoplasia, forefoot hypoplasia, tibial/fibular deformities, abnormal tooth genesis
Phantoms and test objects can be used by
Service personnel and instrument operators.
Manufacturers must submit ___ to the ___ before _________.
Pre market notifications
FDA
marketing a device for a specific application in the U.S.
No significant adverse bio effects have been observed for exposure duration up to ____ from temp increases ____ above normal.
50 hours
Less than or equal to 2*C
Doppler test objects useful for testing:
Effective penetration of Doppler beam
Ability to distinguish different flow directions
Accuracy of sample volume (gate) location
Accuracy of measured flow speed
Sonography requires application of _____ principle which requires _______________.
ALARA
medical indication and using minimum output and exposure time necessary
Output of some current US machines can generate levels that _____.
Produce hemorrhage in lungs and intestines of lab animals.