Siemens
ACUSON Redwood Supplement to the User and Reference Manuals Sw Ver VA20
Supplement
48 Pages
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Page 1
Product Version 2.0 Software Version VA20 ©2023 Siemens Medical Solutions USA, Inc. All Rights Reserved. Date of first issue: 2023-04 The following trademarks are owned by Siemens Medical Solutions USA, Inc. (hereinafter "Siemens"): ACUSON, ACUSON Redwood All other product names are references to third-party products and are trademarks of their respective companies. Siemens includes references to third-party products in the user documentation for informational purposes only. Siemens does not endorse third-party products referenced in the user documentation. Siemens does not assume responsibility for the performance of third-party products. Siemens reserves the right to change its products and services at any time. In addition, this publication is subject to change without notice. Manufacturer Siemens Medical Solutions USA, Inc. Ultrasound 22010 S.E. 51st Street Issaquah, WA 98029 U.S.A. Phone: +1-888-826-9702 siemens-healthineers.com
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Siemens Healthineers Headquarters Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen Germany Phone: +49 9131 84-0 siemens-healthineers.com
Su p pl e me n t t o t he Us er a nd R ef er enc e M a nu a ls
Supplement to the User and Reference Manuals (English) The information in this supplement provides updates to your existing user manuals. For a complete set of operating instructions, you must use this supplement and your ultrasound product's user and reference manuals.
Transducer Surface Temperature (Updated content: Page 2-19, Instructions for Use) Maximum Temperature Transducer
TMM
Still Air
18L6
41.3°C
37.5°C
5C1
42.9°C
40.0°C
5V1
42.7°C
39.4°C
2D-mode Features (Updated content: Page A-5, Instructions for Use)
Persistence levels: transducer dependent
Updates to the Acoustic Output Reference (Updated content: Appendix D, Instructions for Use) The tables on pages 4 through 16 in this publication provide information about the acoustic output reporting for the indicated transducer models.
Summary Table for Acoustic Output
2D with Color and PW Doppler
2D with M-mode
X
X
X
X
Contrast
2D with PW Doppler
X
Elasticity
PW Doppler
X
CW Doppler
2D with Color
18L6
M-mode with Color
Transducer Model
B-mode (2D)
Operating Mode
X
5C1
X
X
X
X
X
X
X
5V1
X
X
X
X
X
X
X
X X
X X
Note: A legend and definitions for the acoustic output reporting tables are available on pages D-6 and D-7 in your Instructions for Use.
Su p pl e me n t t o t he Us er a nd R ef er enc e M a nu a ls
3 / 48
Acoustic Output Reporting Table - Track 3, FDA 510(k) and IEC 60601-2-37 (Per transducer/mode that exceeds MI or TI value of 1.0) Transducer model: 18L6
Operating mode: 2D-mode
Index Label
MI
TIS At surface
Maximum Index Value
1.18
Index Component Value
Operating Control Conditions
Other Information
Acoustic Parameters
IEC
TIB
Below surface
At surface
0.66 0.66
0.66 0.66
0.66
0.79 0.66
Units
pr,α at zMI
(MPa)
P
(mW)
#
22.54
P1x1
(mW)
16.10
16.10
zs
(cm)
zb
(cm)
zMI
(cm)
1.20
zpii,α
(cm)
1.20
fawf
(MHz)
7.22
prr
(Hz)
#
srr
(Hz)
114.47
npps
---
2.00
Ipa,α at zpii,α
(W/cm²)
420.39
Ispta,α at zpii,α or zsii,α
(mW/cm²)
13.93
Ispta at zpii or zsii
(mW/cm²)
21.80
pr at zpii
(MPa)
4.16
TX-Level
(dB)
Focus
(mm)
#
TIC
Below surface
3.08 54.09
# #
8.61
8.61
6.93
0.00
0.00
0.00
0.00
15.00
7.50
7.50
30.00
No data is provided for this operation condition.
Acoustic Output Reporting Table - Track 3, FDA 510(k) and IEC 60601-2-37 (Per transducer/mode that exceeds MI or TI value of 1.0) Transducer model: 18L6
Operating mode: 2D with Color
Index Label
MI
TIS At surface
Maximum Index Value
1.26
Index Component Value
Operating Control Conditions
Other Information
Acoustic Parameters
IEC
#
4 / 48
TIB
Below surface
At surface
0.92 0.90
TIC
Below surface 0.92
0.90
0.90
1.18 0.90
Units
pr,α at zMI
(MPa)
P
(mW)
#
35.56
P1x1
(mW)
22.09
22.09
zs
(cm)
zb
(cm)
zMI
(cm)
1.00
zpii,α
(cm)
1.00
fawf
(MHz)
5.47
prr
(Hz)
#
srr
(Hz)
190.26
npps
---
12.00
Ipa,α at zpii,α
(W/cm²)
380.86
Ispta,α at zpii,α or zsii,α
(mW/cm²)
29.95
Ispta at zpii or zsii
(mW/cm²)
40.51
pr at zpii
(MPa)
3.51
TX-Level
(dB)
Focus
(mm)
2.95 79.91
# #
8.53
8.53
6.96
0.00
0.00
0.00
0.00
15.00
52.50
52.50
40.00
No data is provided for this operation condition.
Su p pl e me n t t o t he Us er a nd R ef er enc e M a nu a ls
Acoustic Output Reporting Table - Track 3, FDA 510(k) and IEC 60601-2-37 (Per transducer/mode that exceeds MI or TI value of 1.0) Transducer model: 18L6
Operating mode: PW Doppler
Index Label
MI
TIS At surface
Maximum Index Value
0.54
Index Component Value
Operating Control Conditions
Other Information
Acoustic Parameters
IEC
TIB
Below surface
At surface
1.29 1.29
1.37 0.57
0.77
1.01 1.37
Units
pr,α at zMI
(MPa)
P
(mW)
#
19.51
P1x1
(mW)
31.88
#
zs
(cm)
zb
(cm)
zMI
(cm)
1.00
zpii,α
(cm)
1.00
fawf
(MHz)
5.44
prr
(Hz)
7961.78
srr
(Hz)
#
npps
---
Ipa,α at zpii,α
(W/cm²)
44.49
Ispta,α at zpii,α or zsii,α
(mW/cm²)
437.00
Ispta at zpii or zsii
(mW/cm²)
667.39
pr at zpii
(MPa)
1.56
TX-Level
(dB)
Focus
(mm)
#
TIC
Below surface
1.25 35.24
1.40 0.90
8.51
8.34
7.25
0.00
0.00
0.00
0.00
15.00
52.50
22.50
52.50
#
No data is provided for this operation condition.
Acoustic Output Reporting Table - Track 3, FDA 510(k) and IEC 60601-2-37 (Per transducer/mode that exceeds MI or TI value of 1.0) Transducer model: 18L6
Operating mode: 2D with PW Doppler
Index Label
MI
TIS At surface
Maximum Index Value
1.10
Index Component Value
Operating Control Conditions
Other Information
Acoustic Parameters
IEC
#
TIB
Below surface
At surface
1.28 1.26
TIC
Below surface 1.35
0.55
0.64
1.00 1.29
Units
pr,α at zMI
(MPa)
P
(mW)
#
18.91
P1x1
(mW)
31.04
#
zs
(cm)
zb
(cm)
zMI
(cm)
0.80
zpii,α
(cm)
0.80
fawf
(MHz)
7.99
prr
(Hz)
#
srr
(Hz)
11.71
npps
---
1.00
Ipa,α at zpii,α
(W/cm²)
337.77
Ispta,α at zpii,α or zsii,α
(mW/cm²)
0.74
Ispta at zpii or zsii
(mW/cm²)
1.15
pr at zpii
(MPa)
3.83
TX-Level
(dB)
Focus
(mm)
3.07 34.27
1.40 1.40
8.51
7.14
7.25
0.00
0.00
0.00
0.00
10.00
52.50
22.50
52.50
No data is provided for this operation condition.
Su p pl e me n t t o t he Us er a nd R ef er enc e M a nu a ls
5 / 48
Acoustic Output Reporting Table - Track 3, FDA 510(k) and IEC 60601-2-37 (Per transducer/mode that exceeds MI or TI value of 1.0) Transducer model: 18L6
Operating mode: 2D with Color and PW Doppler
Index Label
MI
TIS At surface
Maximum Index Value
1.16
Index Component Value
Operating Control Conditions
Other Information
Acoustic Parameters
IEC
TIB
Below surface
At surface
1.29 1.29
1.33 0.57
0.62
1.01 1.25
Units
pr,α at zMI
(MPa)
P
(mW)
#
18.37
P1x1
(mW)
31.84
#
zs
(cm)
zb
(cm)
zMI
(cm)
1.20
zpii,α
(cm)
1.20
fawf
(MHz)
7.22
prr
(Hz)
#
srr
(Hz)
9.08
npps
---
2.00
Ipa,α at zpii,α
(W/cm²)
407.00
Ispta,α at zpii,α or zsii,α
(mW/cm²)
0.12
Ispta at zpii or zsii
(mW/cm²)
0.19
pr at zpii
(MPa)
4.11
TX-Level
(dB)
Focus
(mm)
#
TIC
Below surface
3.05 33.98
1.40 1.40
8.51
7.14
7.25
0.00
0.00
0.00
0.00
15.00
52.50
22.50
52.50
No data is provided for this operation condition.
Acoustic Output Reporting Table - Track 3, FDA 510(k) and IEC 60601-2-37 (Per transducer/mode that exceeds MI or TI value of 1.0) Transducer model: 18L6
Operating mode: 2D with M-mode
Index Label
MI
TIS At surface
Maximum Index Value
1.18
Index Component Value
Operating Control Conditions
Other Information
Acoustic Parameters
IEC
#
6 / 48
TIB
Below surface
At surface
0.58 0.05
TIC
Below surface 0.65
0.03
0.05
0.74 0.12
Units
pr,α at zMI
(MPa)
P
(mW)
#
1.31
P1x1
(mW)
1.31
#
zs
(cm)
zb
(cm)
zMI
(cm)
1.20
zpii,α
(cm)
1.20
fawf
(MHz)
7.22
prr
(Hz)
720.05
srr
(Hz)
#
npps
---
1.00
Ipa,α at zpii,α
(W/cm²)
420.39
Ispta,α at zpii,α or zsii,α
(mW/cm²)
61.77
Ispta at zpii or zsii
(mW/cm²)
112.27
pr at zpii
(MPa)
4.16
TX-Level
(dB)
Focus
(mm)
3.08 2.79
0.70 0.70
7.99
7.99
6.93
0.00
0.00
0.00
0.00
15.00
10.00
10.00
30.00
No data is provided for this operation condition.
Su p pl e me n t t o t he Us er a nd R ef er enc e M a nu a ls
Acoustic Output Reporting Table - Track 3, FDA 510(k) and IEC 60601-2-37 (Per transducer/mode that exceeds MI or TI value of 1.0) Transducer model: 18L6
Operating mode: Contrast
Index Label
MI
TIS At surface
Maximum Index Value
1.21
Index Component Value
Operating Control Conditions
Other Information
Acoustic Parameters
IEC
TIB
Below surface
At surface
1.14 1.05
1.14 1.05
1.05
1.31 1.05
Units
pr,α at zMI
(MPa)
P
(mW)
#
43.66
P1x1
(mW)
31.01
31.01
zs
(cm)
zb
(cm)
zMI
(cm)
1.20
zpii,α
(cm)
1.20
fawf
(MHz)
6.16
prr
(Hz)
#
srr
(Hz)
48.51
npps
---
3.00
Ipa,α at zpii,α
(W/cm²)
416.55
Ispta,α at zpii,α or zsii,α
(mW/cm²)
2.96
Ispta at zpii or zsii
(mW/cm²)
4.33
pr at zpii
(MPa)
3.61
TX-Level
(dB)
Focus
(mm)
#
TIC
Below surface
2.99 83.21
# #
7.10
7.10
7.05
0.00
0.00
0.00
0.00
15.00
10.00
10.00
40.00
No data is provided for this operation condition.
Acoustic Output Reporting Table - Track 3, FDA 510(k) and IEC 60601-2-37 (Per transducer/mode that exceeds MI or TI value of 1.0) Transducer model: 5C1
Operating mode: 2D-mode
Index Label
MI
TIS At surface
Maximum Index Value
1.40
Index Component Value
Operating Control Conditions
Other Information
Acoustic Parameters
IEC
#
TIB
Below surface
At surface
1.73 1.73
TIC
Below surface 1.73
1.73
1.73
3.54 1.73
Units
pr,α at zMI
(MPa)
P
(mW)
#
191.40
P1x1
(mW)
99.26
99.26
zs
(cm)
zb
(cm)
zMI
(cm)
5.10
zpii,α
(cm)
5.10
fawf
(MHz)
2.24
prr
(Hz)
#
srr
(Hz)
33.27
npps
---
1.00
Ipa,α at zpii,α
(W/cm²)
314.31
Ispta,α at zpii,α or zsii,α
(mW/cm²)
65.21
Ispta at zpii or zsii
(mW/cm²)
111.91
pr at zpii
(MPa)
2.96
TX-Level
(dB)
Focus
(mm)
2.07 418.67
# #
3.65
3.65
2.24
0.00
0.00
0.00
0.00
80.00
60.00
60.00
130.00
No data is provided for this operation condition.
Su p pl e me n t t o t he Us er a nd R ef er enc e M a nu a ls
7 / 48
Acoustic Output Reporting Table - Track 3, FDA 510(k) and IEC 60601-2-37 (Per transducer/mode that exceeds MI or TI value of 1.0) Transducer model: 5C1
Operating mode: 2D with Color
Index Label
MI
TIS At surface
Maximum Index Value
1.41
Index Component Value
Operating Control Conditions
Other Information
Acoustic Parameters
IEC
TIB
Below surface
At surface
1.73 1.69
1.73 1.69
1.69
4.69 1.69
Units
pr,α at zMI
(MPa)
P
(mW)
#
236.68
P1x1
(mW)
89.98
89.98
zs
(cm)
zb
(cm)
zMI
(cm)
5.00
zpii,α
(cm)
5.00
fawf
(MHz)
2.08
prr
(Hz)
#
srr
(Hz)
13.62
npps
---
2.00
Ipa,α at zpii,α
(W/cm²)
303.56
Ispta,α at zpii,α or zsii,α
(mW/cm²)
5.95
Ispta at zpii or zsii
(mW/cm²)
9.83
pr at zpii
(MPa)
2.70
TX-Level
(dB)
Focus
(mm)
#
TIC
Below surface
1.99 551.02
# #
3.96
3.96
2.67
0.00
0.00
0.00
0.00
60.00
55.00
55.00
190.00
No data is provided for this operation condition.
Acoustic Output Reporting Table - Track 3, FDA 510(k) and IEC 60601-2-37 (Per transducer/mode that exceeds MI or TI value of 1.0) Transducer model: 5C1
Operating mode: PW Doppler
Index Label
MI
TIS At surface
Maximum Index Value
0.55
Index Component Value
Operating Control Conditions
Other Information
Acoustic Parameters
IEC
#
8 / 48
TIB
Below surface
At surface
2.16 0.96
TIC
Below surface 4.24
2.16
0.78
3.68 4.24
Units
pr,α at zMI
(MPa)
P
(mW)
#
301.75
P1x1
(mW)
76.90
#
zs
(cm)
zb
(cm)
zMI
(cm)
3.80
zpii,α
(cm)
3.80
fawf
(MHz)
3.31
prr
(Hz)
7961.78
srr
(Hz)
#
npps
---
Ipa,α at zpii,α
(W/cm²)
Ispta,α at zpii,α or zsii,α
(mW/cm²)
400.27
Ispta at zpii or zsii
(mW/cm²)
1117.70
pr at zpii
(MPa)
1.57
TX-Level
(dB)
Focus
(mm)
1.01 408.07
3.80 3.90
2.62
2.06
2.60
0.00
0.00
0.00
0.00
40.00
110.00
95.00
145.00
# 44.84
No data is provided for this operation condition.
Su p pl e me n t t o t he Us er a nd R ef er enc e M a nu a ls
Acoustic Output Reporting Table - Track 3, FDA 510(k) and IEC 60601-2-37 (Per transducer/mode that exceeds MI or TI value of 1.0) Transducer model: 5C1
Operating mode: 2D with PW Doppler
Index Label
MI
TIS At surface
Maximum Index Value
1.40
Index Component Value
Operating Control Conditions
Other Information
Acoustic Parameters
IEC
TIB
Below surface
At surface
2.14 0.93
4.18 2.10
0.76
3.54 4.17
Units
pr,α at zMI
(MPa)
P
(mW)
#
296.70
P1x1
(mW)
74.81
#
zs
(cm)
zb
(cm)
zMI
(cm)
4.00
zpii,α
(cm)
4.00
fawf
(MHz)
2.20
prr
(Hz)
#
srr
(Hz)
3.99
npps
---
2.00
Ipa,α at zpii,α
(W/cm²)
194.90
Ispta,α at zpii,α or zsii,α
(mW/cm²)
4.43
Ispta at zpii or zsii
(mW/cm²)
7.88
pr at zpii
(MPa)
2.23
TX-Level
(dB)
Focus
(mm)
#
TIC
Below surface
2.08 380.52
3.80 3.90
2.62
2.06
2.60
0.00
0.00
0.00
0.00
95.00
110.00
95.00
145.00
No data is provided for this operation condition.
Acoustic Output Reporting Table - Track 3, FDA 510(k) and IEC 60601-2-37 (Per transducer/mode that exceeds MI or TI value of 1.0) Transducer model: 5C1
Operating mode: 2D with Color and PW Doppler
Index Label
MI
TIS At surface
Maximum Index Value
1.40
Index Component Value
Operating Control Conditions
Other Information
Acoustic Parameters
IEC
#
TIB
Below surface
At surface
2.07 0.93
TIC
Below surface 4.11
2.06
0.75
3.70 4.08
Units
pr,α at zMI
(MPa)
P
(mW)
#
290.57
P1x1
(mW)
74.32
#
zs
(cm)
zb
(cm)
zMI
(cm)
4.10
zpii,α
(cm)
4.10
fawf
(MHz)
2.13
prr
(Hz)
#
srr
(Hz)
4.53
npps
---
2.00
Ipa,α at zpii,α
(W/cm²)
173.09
Ispta,α at zpii,α or zsii,α
(mW/cm²)
9.40
Ispta at zpii or zsii
(mW/cm²)
16.19
pr at zpii
(MPa)
2.60
TX-Level
(dB)
Focus
(mm)
2.02 371.34
3.80 3.90
2.62
2.06
2.60
0.00
0.00
0.00
0.00
130.00
110.00
95.00
145.00
No data is provided for this operation condition.
Su p pl e me n t t o t he Us er a nd R ef er enc e M a nu a ls
9 / 48
Acoustic Output Reporting Table - Track 3, FDA 510(k) and IEC 60601-2-37 (Per transducer/mode that exceeds MI or TI value of 1.0) Transducer model: 5C1
Operating mode: 2D with M-mode
Index Label
MI
TIS At surface
Maximum Index Value
1.40
Index Component Value
Operating Control Conditions
Other Information
Acoustic Parameters
IEC
TIB
Below surface
At surface
1.39 0.31
2.59 0.90
0.36
3.54 2.29
Units
pr,α at zMI
(MPa)
P
(mW)
#
190.93
P1x1
(mW)
32.91
#
zs
(cm)
zb
(cm)
zMI
(cm)
3.80
zpii,α
(cm)
3.80
fawf
(MHz)
2.29
prr
(Hz)
720.05
srr
(Hz)
#
npps
---
1.00
Ipa,α at zpii,α
(W/cm²)
154.86
Ispta,α at zpii,α or zsii,α
(mW/cm²)
107.51
Ispta at zpii or zsii
(mW/cm²)
190.60
pr at zpii
(MPa)
2.64
TX-Level
(dB)
Focus
(mm)
#
TIC
Below surface
2.09 130.50
3.80 3.80
1.95
1.95
2.24
0.00
0.00
0.00
0.00
145.00
145.00
190.00
130.00
No data is provided for this operation condition.
Acoustic Output Reporting Table - Track 3, FDA 510(k) and IEC 60601-2-37 (Per transducer/mode that exceeds MI or TI value of 1.0) Transducer model: 5C1
Operating mode: M-mode with Color
Index Label
MI
TIS At surface
Maximum Index Value
1.40
Operating Control Conditions
Other Information
Acoustic Parameters
Index Component Value
TIB
Below surface
At surface
2.22 0.98
4.45 2.16
0.67
Units
pr,α at zMI
(MPa)
P
(mW)
#
261.08
P1x1
(mW)
78.55
68.42
zs
(cm)
zb
(cm)
zMI
(cm)
4.10
zpii,α
(cm)
4.10
fawf
(MHz)
2.13
prr
(Hz)
213.00
srr
(Hz)
#
npps
---
1.00
Ipa,α at zpii,α
(W/cm²)
173.09
Ispta,α at zpii,α or zsii,α
(mW/cm²)
39.86
Ispta at zpii or zsii
(mW/cm²)
70.97
pr at zpii
(MPa)
2.60
TX-Level
(dB)
Focus
(mm)
10 / 48
3.86 3.68
IEC
#
TIC
Below surface
2.02 397.06
3.90 3.90
2.62
2.06
2.60
0.00
0.00
0.00
0.00
130.00
110.00
95.00
145.00
No data is provided for this operation condition.
Su p pl e me n t t o t he Us er a nd R ef er enc e M a nu a ls
Acoustic Output Reporting Table - Track 3, FDA 510(k) and IEC 60601-2-37 (Per transducer/mode that exceeds MI or TI value of 1.0) Transducer model: 5C1
Operating mode: Elasticity
Index Label
MI
TIS At surface
Maximum Index Value
1.24
Index Component Value
Operating Control Conditions
Other Information
Acoustic Parameters
IEC
TIB
Below surface
At surface
1.07 0.85
2.15 0.98
0.83
2.81 2.06
Units
pr,α at zMI
(MPa)
P
(mW)
#
164.27
P1x1
(mW)
71.05
#
zs
(cm)
zb
(cm)
zMI
(cm)
3.50
zpii,α
(cm)
3.50
fawf
(MHz)
2.50
prr
(Hz)
#
srr
(Hz)
2.32
npps
---
Ipa,α at zpii,α
(W/cm²)
281.88
Ispta,α at zpii,α or zsii,α
(mW/cm²)
203.84
Ispta at zpii or zsii
(mW/cm²)
342.69
pr at zpii
(MPa)
2.46
TX-Level
(dB)
Focus
(mm)
#
TIC
Below surface
1.96 214.03
4.60 5.60
2.50
2.50
2.50
0.00
0.00
0.00
0.00
26.90
74.20
69.20
92.00
#
No data is provided for this operation condition.
Acoustic Output Reporting Table - Track 3, FDA 510(k) and IEC 60601-2-37 (Per transducer/mode that exceeds MI or TI value of 1.0) Transducer model: 5C1
Operating mode: Contrast
Index Label
MI
TIS At surface
Maximum Index Value
1.40
Index Component Value
Operating Control Conditions
Other Information
Acoustic Parameters
IEC
#
TIB
Below surface
At surface
1.45 0.98
TIC
Below surface 1.45
0.98
0.98
4.00 0.98
Units
pr,α at zMI
(MPa)
P
(mW)
#
137.44
P1x1
(mW)
85.26
85.26
zs
(cm)
zb
(cm)
zMI
(cm)
3.70
zpii,α
(cm)
3.80
fawf
(MHz)
2.27
prr
(Hz)
#
srr
(Hz)
3.70
npps
---
2.00
Ipa,α at zpii,α
(W/cm²)
153.75
Ispta,α at zpii,α or zsii,α
(mW/cm²)
14.22
Ispta at zpii or zsii
(mW/cm²)
25.75
pr at zpii
(MPa)
2.50
TX-Level
(dB)
Focus
(mm)
2.10 390.06
# #
2.41
2.41
2.31
0.00
0.00
0.00
0.00
190.00
40.00
40.00
130.00
No data is provided for this operation condition.
Su p pl e me n t t o t he Us er a nd R ef er enc e M a nu a ls
11 / 48
Acoustic Output Reporting Table - Track 3, FDA 510(k) and IEC 60601-2-37 (Per transducer/mode that exceeds MI or TI value of 1.0) Transducer model: 5V1
Operating mode: 2D-mode
Index Label
MI
TIS At surface
Maximum Index Value
1.37
Index Component Value
Operating Control Conditions
Other Information
Acoustic Parameters
IEC
TIB
Below surface
At surface
2.85 2.85
2.85 2.85
2.85
5.13 2.85
Units
pr,α at zMI
(MPa)
P
(mW)
#
304.68
P1x1
(mW)
194.33
194.33
zs
(cm)
zb
(cm)
zMI
(cm)
5.10
zpii,α
(cm)
5.10
fawf
(MHz)
2.01
prr
(Hz)
#
srr
(Hz)
109.39
npps
---
2.00
Ipa,α at zpii,α
(W/cm²)
361.49
Ispta,α at zpii,α or zsii,α
(mW/cm²)
45.53
Ispta at zpii or zsii
(mW/cm²)
78.29
pr at zpii
(MPa)
2.79
TX-Level
(dB)
Focus
(mm)
#
TIC
Below surface
1.96 215.69
# #
3.08
3.08
3.17
0.00
0.00
0.00
0.00
60.00
60.00
60.00
20.00
No data is provided for this operation condition.
Acoustic Output Reporting Table - Track 3, FDA 510(k) and IEC 60601-2-37 (Per transducer/mode that exceeds MI or TI value of 1.0) Transducer model: 5V1
Operating mode: 2D with Color
Index Label
MI
TIS At surface
Maximum Index Value
1.37
Index Component Value
Operating Control Conditions
Other Information
Acoustic Parameters
IEC
TIB
Below surface
At surface
2.33 1.20
2.33 1.20
1.20
Units
(MPa)
P
(mW)
#
112.19
P1x1
(mW)
74.50
74.50
zs
(cm)
zb
(cm)
zMI
(cm)
5.10
zpii,α
(cm)
5.10
fawf
(MHz)
2.01
prr
(Hz)
#
srr
(Hz)
17.38
npps
---
2.00
Ipa,α at zpii,α
(W/cm²)
361.49
Ispta,α at zpii,α or zsii,α
(mW/cm²)
4.60
Ispta at zpii or zsii
(mW/cm²)
7.90
pr at zpii
(MPa)
2.79
TX-Level
(dB)
Focus
(mm)
12 / 48
4.07 1.20
pr,α at zMI
#
TIC
Below surface
1.96 109.57
# #
3.38
3.38
1.97
0.00
0.00
0.00
0.00
60.00
20.00
20.00
80.00
No data is provided for this operation condition.
Su p pl e me n t t o t he Us er a nd R ef er enc e M a nu a ls
Acoustic Output Reporting Table - Track 3, FDA 510(k) and IEC 60601-2-37 (Per transducer/mode that exceeds MI or TI value of 1.0) Transducer model: 5V1
Operating mode: PW Doppler
Index Label
MI
TIS At surface
Maximum Index Value
0.96
Index Component Value
Operating Control Conditions
Other Information
Acoustic Parameters
IEC
TIB
Below surface
At surface
2.04 1.56
4.46 2.04
0.71
3.50 4.46
Units
pr,α at zMI
(MPa)
P
(mW)
#
187.37
P1x1
(mW)
95.82
#
zs
(cm)
zb
(cm)
zMI
(cm)
1.50
zpii,α
(cm)
1.90
fawf
(MHz)
1.81
prr
(Hz)
5980.86
srr
(Hz)
#
npps
---
1.00
Ipa,α at zpii,α
(W/cm²)
55.00
Ispta,α at zpii,α or zsii,α
(mW/cm²)
500.09
Ispta at zpii or zsii
(mW/cm²)
700.85
pr at zpii
(MPa)
1.39
TX-Level
(dB)
Focus
(mm)
#
TIC
Below surface
1.30 248.27
2.70 3.30
3.42
1.98
2.96
0.00
0.00
0.00
0.00
20.00
150.00
100.00
180.00
No data is provided for this operation condition.
Acoustic Output Reporting Table - Track 3, FDA 510(k) and IEC 60601-2-37 (Per transducer/mode that exceeds MI or TI value of 1.0) Transducer model: 5V1
Operating mode: 2D with PW Doppler
Index Label
MI
TIS At surface
Maximum Index Value
1.37
Index Component Value
Operating Control Conditions
Other Information
Acoustic Parameters
IEC
#
TIB
Below surface
At surface
2.18 0.96
TIC
Below surface 4.52
1.26
0.73
3.97 3.95
Units
pr,α at zMI
(MPa)
P
(mW)
#
103.26
P1x1
(mW)
59.54
#
zs
(cm)
zb
(cm)
zMI
(cm)
4.50
zpii,α
(cm)
4.50
fawf
(MHz)
1.64
prr
(Hz)
#
srr
(Hz)
6.59
npps
---
1.00
Ipa,α at zpii,α
(W/cm²)
142.27
Ispta,α at zpii,α or zsii,α
(mW/cm²)
5.39
Ispta at zpii or zsii
(mW/cm²)
8.02
pr at zpii
(MPa)
2.11
TX-Level
(dB)
Focus
(mm)
1.75 134.99
2.70 1.90
3.37
1.81
2.96
0.00
0.00
0.00
0.00
60.00
100.00
20.00
120.00
No data is provided for this operation condition.
Su p pl e me n t t o t he Us er a nd R ef er enc e M a nu a ls
13 / 48
Acoustic Output Reporting Table - Track 3, FDA 510(k) and IEC 60601-2-37 (Per transducer/mode that exceeds MI or TI value of 1.0) Transducer model: 5V1
Operating mode: 2D with Color and PW Doppler
Index Label
MI
TIS At surface
Maximum Index Value
1.34
Index Component Value
Operating Control Conditions
Other Information
Acoustic Parameters
IEC
TIB
Below surface
At surface
1.98 1.17
4.37 1.53
0.72
3.69 3.86
Units
pr,α at zMI
(MPa)
P
(mW)
#
101.02
P1x1
(mW)
71.89
#
zs
(cm)
zb
(cm)
zMI
(cm)
3.80
zpii,α
(cm)
3.80
fawf
(MHz)
1.63
prr
(Hz)
#
srr
(Hz)
3.10
npps
---
1.00
Ipa,α at zpii,α
(W/cm²)
108.34
Ispta,α at zpii,α or zsii,α
(mW/cm²)
4.01
Ispta at zpii or zsii
(mW/cm²)
5.95
pr at zpii
(MPa)
1.85
TX-Level
(dB)
Focus
(mm)
#
TIC
Below surface
1.70 137.34
2.70 1.90
3.42
1.81
2.96
0.00
0.00
0.00
0.00
120.00
150.00
20.00
120.00
No data is provided for this operation condition.
Acoustic Output Reporting Table - Track 3, FDA 510(k) and IEC 60601-2-37 (Per transducer/mode that exceeds MI or TI value of 1.0) Transducer model: 5V1
Operating mode: 2D with M-mode
Index Label
MI
TIS At surface
Maximum Index Value
1.37
Index Component Value
Operating Control Conditions
Other Information
Acoustic Parameters
IEC
TIB
Below surface
At surface
2.77 0.39
3.02 0.28
0.51
Units
(MPa)
P
(mW)
#
91.60
P1x1
(mW)
25.88
#
zs
(cm)
zb
(cm)
zMI
(cm)
4.60
zpii,α
(cm)
4.60
fawf
(MHz)
2.05
prr
(Hz)
720.05
srr
(Hz)
#
npps
---
1.00
Ipa,α at zpii,α
(W/cm²)
333.51
Ispta,α at zpii,α or zsii,α
(mW/cm²)
186.46
Ispta at zpii or zsii
(mW/cm²)
354.17
pr at zpii
(MPa)
2.59
TX-Level
(dB)
Focus
(mm)
14 / 48
5.13 1.88
pr,α at zMI
#
TIC
Below surface
1.95 106.56
1.60 4.50
3.17
2.05
2.14
0.00
0.00
0.00
0.00
60.00
20.00
60.00
180.00
No data is provided for this operation condition.
Su p pl e me n t t o t he Us er a nd R ef er enc e M a nu a ls
Acoustic Output Reporting Table - Track 3, FDA 510(k) and IEC 60601-2-37 (Per transducer/mode that exceeds MI or TI value of 1.0) Transducer model: 5V1
Operating mode: M-mode with Color
Index Label
MI
TIS At surface
Maximum Index Value
1.37
Index Component Value
Operating Control Conditions
Other Information
Acoustic Parameters
IEC
TIB
Below surface
At surface
1.68 0.84
4.77 1.43
0.79
3.57 4.52
Units
pr,α at zMI
(MPa)
P
(mW)
#
208.78
P1x1
(mW)
88.85
#
zs
(cm)
zb
(cm)
zMI
(cm)
3.80
zpii,α
(cm)
3.80
fawf
(MHz)
1.99
prr
(Hz)
1042.46
srr
(Hz)
#
npps
---
1.00
Ipa,α at zpii,α
(W/cm²)
239.14
Ispta,α at zpii,α or zsii,α
(mW/cm²)
330.14
Ispta at zpii or zsii
(mW/cm²)
555.94
pr at zpii
(MPa)
2.52
TX-Level
(dB)
Focus
(mm)
#
TIC
Below surface
1.94 245.19
2.70 3.30
1.98
1.98
1.98
0.00
0.00
0.00
0.00
40.00
100.00
100.00
180.00
No data is provided for this operation condition.
Acoustic Output Reporting Table - Track 3, FDA 510(k) and IEC 60601-2-37 (Per transducer/mode that exceeds MI or TI value of 1.0) Transducer model: 5V1
Operating mode: CW Doppler
Index Label
MI
TIS At surface
Maximum Index Value
0.09
Index Component Value
Operating Control Conditions
Other Information
Acoustic Parameters
IEC
#
TIB
Below surface
At surface
0.42 0.42
TIC
Below surface 2.84
0.38
0.39
1.15 2.84
Units
pr,α at zMI
(MPa)
P
(mW)
#
51.72
P1x1
(mW)
48.83
#
zs
(cm)
zb
(cm)
zMI
(cm)
3.60
zpii,α
(cm)
3.60
fawf
(MHz)
1.80
prr
(Hz)
1818200.00
srr
(Hz)
#
npps
---
1.00
Ipa,α at zpii,α
(W/cm²)
0.50
Ispta,α at zpii,α or zsii,α
(mW/cm²)
498.30
Ispta at zpii or zsii
(mW/cm²)
791.67
pr at zpii
(MPa)
0.15
TX-Level
(dB)
Focus
(mm)
0.12 55.43
1.90 2.50
1.80
1.80
1.80
0.00
0.00
0.00
0.00
60.00
180.00
20.00
180.00
No data is provided for this operation condition.
Su p pl e me n t t o t he Us er a nd R ef er enc e M a nu a ls
15 / 48
Acoustic Output Reporting Table - Track 3, FDA 510(k) and IEC 60601-2-37 (Per transducer/mode that exceeds MI or TI value of 1.0) Transducer model: 5V1
Operating mode: Contrast
Index Label
MI
TIS At surface
Maximum Index Value
1.37
Index Component Value
Operating Control Conditions
Other Information
Acoustic Parameters
IEC
TIB
Below surface
At surface
1.38 1.20
1.38 1.20
1.20
Units
(MPa)
P
(mW)
#
121.48
P1x1
(mW)
77.48
77.48
zs
(cm)
zb
(cm)
zMI
(cm)
4.60
zpii,α
(cm)
4.60
fawf
(MHz)
2.04
prr
(Hz)
#
srr
(Hz)
82.12
npps
---
2.00
Ipa,α at zpii,α
(W/cm²)
322.20
Ispta,α at zpii,α or zsii,α
(mW/cm²)
46.94
Ispta at zpii or zsii
(mW/cm²)
84.77
pr at zpii
(MPa)
2.57
TX-Level
(dB)
Focus
(mm)
16 / 48
2.85 1.20
pr,α at zMI
#
TIC
Below surface
1.95 103.41
# #
3.26
3.26
2.30
0.00
0.00
0.00
0.00
60.00
60.00
60.00
20.00
No data is provided for this operation condition.
Su p pl e me n t t o t he Us er a nd R ef er enc e M a nu a ls
48 / 48
Su p pl e me n t t o t he Us er a nd R ef er enc e M a nu a ls