Butterfly Network iQ - Page 98

and to minimize patient exposure to potential harmful effects and unnecessary risk. Ultrasound users should be
knowledgeable in ultrasound procedures and be able to perform them at output levels and exposure times that are
As Low As Reasonably Achievable (ALARA). ALARA is defined as ultrasound exposure kept as low as reasonably
achievable while optimizing diagnostic information.
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
reasons 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
assumptions 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
recommended 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/ iQ+/ iQ3 adheres to conformance with FDA Track 3 output settings, output display and ALARA
safety principles. 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 22. Diagnostic Ultrasound Indications for Butterfly iQ/ iQ+/ iQ3
Transducer: Butterfly iQ/ iQ+/ iQ3 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
iQ
Slice
iQ
Fan
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 X
B-Mode + M-
Mode
B-Mode + Color
Doppler
B-Mode + Power
Doppler
B-Mode + iQ
Slice
Lung
X X X
B-Mode + M-
Mode
B-Mode + iQ Fan
Intraoperative
(Specify)
Intra-operative
(Neuro)
Laparoscopic
Acoustic Output
Specifications 98