Siemens Acuson S3000 - Track 3, FDA 510(k) and IEC 60601-2-37 Acoustic Output Reporting

Appendix F Acoustic Output Reference
F - 6 Instructions for Use
Track 3, FDA 510(k) and IEC 60601-2-37 Acoustic Output
Reporting
Data presented in Track 3 and IEC 60601-2-37 format represents the average MI/TI values of
each transducer model measured under worst-case acoustic output conditions. The on-screen
MI/TI values are based on measurements on one transducer rounded up to the nearest display
increment. It is possible that the values displayed on screen may exceed the MI/TI values
presented in the Track 3 and IEC 60601-2-37 format.
Summary Table for Acoustic Output
An "X" indicates that either the MI index or TI indices is greater than 1.0 for each
transducer/mode. A Track 3 and IEC 60601-2-37 format acoustic output table is supplied for
each transducer/mode combination marked with an "X."
Operating Mode
Transducer
Model
B-mode
(2D)
2D-mode
(THI)
M-mode
Pulsed
Doppler
Color Flow
or Power
SCW
Doppler
CW
Doppler
(Available on the ACUSON S1000 system, ACUSON S2000 system, and the ACUSON S3000 system)
4C1 X X X X X
6C2
X
X
X
X
X
9L4
X
X
X
X
X
12L4
X
X
X
X
X
14L5 X X X X X
14L5 SP X X X X X
18L6 HD
X
X
X
X
X
4P1
X
X
X
X
X
X
4V1
X
X
X
X
X
4V1c X X X X X X
8V3
X
X
X
X
X
X
10V4
X
X
X
X
X
X
V5Ms
X
X
X
X
X
V7M X X X X X
EV-8C4 X X X X X
EC9-4
X
X
X
X
X
MC9-4
X
X
X
X
X
7CF1 X X X X X
7CF2
X
X
X
X
X
9EVF4
X
X
X
X
X
CW2
X
CW5 X
AcuNav 8F X X X X X
AcuNav 10F X X X X X
(Available only on the ACUSON S2000 system and the ACUSON S3000 system)
6C1 HD X X X X X
8C3 HD
X
X
X
X
X