ALARA training is provided by the American Institute of Ultrasound in Medicine (AIUM) in a booklet, “Medical Ultra-
sound Safety.” This booklet is provided as a PDF link in the Butterfly iQ™ App and the Butterfly Cloud web interface.
It provides training and educational information on ultrasound bio effects and biophysics, prudent use and imple-
menting ALARA.
An example of the ALARA principle is during obstetric ultrasound. Minimizing, for example, the use of Color Doppler,
limiting dwell time, scanning only critical structures required for the study, and avoiding studies for non medical rea-
sons are all manifestations of a reduction in exposure to ultrasonic energy.
Output display uncertainty
MI and TI output display accuracy is dependent on the precision of the measurement system, engineering assump-
tions within the acoustic model used to calculate the parameters, and variability in the acoustic output of probes.
Butterfly compares both internal and 3rd party acoustic and confirms that both measurements are within recommen-
ded display quantization of 0.2 as outlined by the standards. Note that all MI and TI values displayed on the device
will not exceed the maximum global values (listed in the tables below) by more than 0.2.
Track 3 Specific Information
The Butterfly iQ™ adheres to conformance with FDA Track 3 output settings, output display and ALARA safety prin-
ciples. In support of Track 3 acoustic output, the following tables provide the global maximum acoustic output indices
for the probe and each of its clinical output modes.
Table 10. Probe/Mode Combination Summary System: Butterfly iQ™
Probe Model
Mode of Operation
B
M
PWD
CWD
Color Doppler
Power Doppler
Combined (Specify)
Other* (Specify)
Butterfly iQ™
X
X
X
X
X
B+M Mode
Table 11. Diagnostic Ultrasound Indications for Butterfly iQ™
Transducer: Butterfly iQ™ Ultrasound System transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application
Mode of Operation
General (Track 1 Only)
Specific (Tracks 1 & 3)
B
M
Power
PWD
Color Doppler
Combined (Specify)
Ophthalmic
Ophthalmic
X
X
X
B-Mode + Color Doppler
B-Mode + Power Doppler
Fetal Imaging & Other
Fetal/Obstetric
X
X
X
X
B-Mode + M-Mode
B-Mode + Color Doppler
B-Mode + Power Doppler
Abdominal
X
X
X
X
B-Mode + M-Mode
B-Mode + Color Doppler
B-Mode + Power Doppler
Intraoperative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
X
X
X
X
B-Mode + M-Mode
B-Mode + Color Doppler
B-Mode + Power Doppler
Small Organ (including
scrotum, thyroid, breast)
X
X
X
X
B-Mode + M-Mode
B-Mode + Color Doppler
B-Mode + Power Doppler
Acoustic Output
Specifications
45