Butterfly Network iQ - Acoustic Output Limits; Acoustic Output Tables

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)
Cardiac Pediatric X X X
B-Mode + M-
Mode
B-Mode + Color
Doppler
Intravascular
(Cardiac)
Trans-esoph.
(Cardiac)
Intra-cardiac
Peripheral
Vessel
Peripheral vessel X X X X
B-Mode + M-
Mode
B-Mode + Color
Doppler
B-Mode + Power
Doppler
Other (Carotid,
deep vein
thrombosis,
arterial studies)
X X X X
B-Mode + M-
Mode
B-Mode + Color
Doppler
B-Mode + Power
Doppler
Other (Procedural
Guidance)
X X X X X
B-Mode + M-
Mode
B-Mode + Color
Doppler
B-Mode + Power
Doppler
18.6.1. Acoustic Output Limits
The ultrasound system maintains acoustic outputs below the appropriate limits for each application listed below.
Non ophthalmic applications:
System Probe
I
SPTA.3
TI Type TI Value MI I
PA.3
@MI
max
Butterfly iQ/ iQ+/ iQ3 146.47 mW/cm
2
TIB 0.85 0.51 102 W/cm
2
Ophthalmic applications:
System Probe
I
SPTA.3
TI Type TI Value MI I
PA.3
@MI
max
Butterfly iQ/ iQ+/ iQ3 8.12 mW/cm
2
TIB 0.047 0.162 6.48 W/cm
2
For additional information please visit support.butterflynetwork.com.
18.6.2. Acoustic Output Tables
NOTE
For complete definitions of the measurements used in Acoustic Output Tables [100] please
reference Table 201.101 in IEC 60601-2-37.
Acoustic Output
Specifications 100