Siemens Sonoline G60 S User manual

SONOLINE G60 S Ultrasound Imaging System System Reference

Siemens Medical Solutions USA, Inc. 10034099-ABS-001-01-01

SONOLINE G60 S Ultrasound Imaging System System Reference

Software Version 10

Siemens Medical Solutions USA, Inc. Ultrasound Division 1230 Shorebird Way Mountain View, CA 94043-1344 U.S.A.

(800) 498-7948 (650) 969-9112

CE Declaration

For systems affixed with a CE mark: This product is provided with a CE marking in accordance with the regulations stated in Council Directive 93/42/EEC of June 14, 1993 concerning Medical Devices. Siemens Medical Solutions USA, Inc., is certified by Notified Body 0123 to Annex II.3 – Full Quality System.

Authorized EC Representative: Siemens Aktiengesellschaft Medical Solutions Henkestraße 127 D-91052 Erlangen Germany

February 2006 Manuals distributed from the United States of America are printed in the

United States of America.

SONOLINE G60 S, Axius, DTI, fourSight, SieScape, MultiHertz, DIMAQ, microCase, ErgoDynamic, SynAps, QuickSet, SuppleFlex, Crescendo, and Evolve Package are trademarks of Siemens Medical Solutions USA, Inc.

Windows, CIDEX, CIDEX Plus, CIDEX OPA, Milton, Virkon, and Gigasept FF are registered trademarks of their respective owners.

Siemens reserves the right to change system specifications at any time.

SYSTEM REFERENCE i

ii SYSTEM REFERENCE

About This Manual

The Instructions for Use consists of two volumes:

 [1] Instructions for Use The [1] Instructions for Use includes both a general overview and a

technical description of the ultrasound imaging system. This manual contains detailed information on the safety and care of the ultrasound system and its transducers. A chapter is dedicated to the description of all system controls. The [1] Instructions for Use also includes the procedures for system setup and beginning an exam.

 [2] Instructions for Use The [2] Instructions for Use includes procedures for acquiring and

optimizing images. This manual provides procedures for general and exam-specific measurements and calculations.

The System Reference provides reference information for the ultrasound imaging system.

The Electromagnetic Emissions and Immunity: Guidance and Manufacturer's Declaration publication provides information regarding the electromagnetic compatibility (EMC) testing of this system.

SYSTEM REFERENCE v

Conventions

Conventions used throughout this manual are listed below. Take a moment to familiarize yourself with these conventions.

Cross-References

This manual provides you information by topic. When additional information exists within this or other manuals, a reference graphic and the name of the book is provided in the right column. If the information exists within the chapter, a cross-reference to the page number is listed. Otherwise, information is referenced by chapter number.

System Presets

You can use the options and settings available in the system presets menu to set up the ultrasound system with your preferences. Presets define the configuration of the system software whenever you power on the system.

A complete listing of system presets is located in the System Reference. Whenever a system preset is discussed in other chapters or in the User and Reference Manuals, a graphic is provided in the right column.

The graphic identifies a preset option or setting in the system presets menu that is available for you to customize your ultrasound system. The name of the category on the menu containing the system preset is listed for your convenience.

[1] Instructions for Use

Screen Saver Ch 1 Intended Use Ch 1

[2] Instructions for Use

Imaging Functions Ch A1

System Reference

Accessories

and Options Ch 2



F4

Default Settings

► Automatic Freeze

Response

vi SYSTEM REFERENCE

Warnings, Cautions, and Notes

WARNING: Warnings are intended to alert you to the importance of following

the correct operating procedures where risk of injury to the patient or system user exists.

Caution: Cautions are intended to alert you to the importance of following

correct operating procedures to prevent the risk of damage to the system.

Note: Notes contain information concerning the proper use of the system and/or correct execution of a procedure.

Control Panel Keys, Controls, and LCD Selections

Keys and controls located on the control panel are identified by uppercase, boldface type.

Example: Rotate the ZOOM control.

Function keys located on the keyboard are identified by the number of the function key.

Example: Press the F4 key.

LCD keys are indicated by a (|) symbol with the name of the selection in boldface type.

Example: Press |Next to access the second page of LCD selections.

SYSTEM REFERENCE vii

Selection of On-Screen Objects

The SET key on the control panel functions as a point-and-select device (similar to a computer mouse) when used with the trackball. To select an on-screen object such as a button or a T symbol, roll the trackball to position the pointer (cursor) on the object and then press the SET key on the control panel.

In this manual, the term "select" or "click" describe the trackball and SET key action required to select an on-screen object. In the example below, phrases A, B, C, and D are equivalent actions.

A. Roll the trackball to the Search button and then press the SET key. B. Select the Search button. C. Click the Search button. D. Click Search.

Special Terms and Menu Options

Special terms are indicated in boldface italics and are accompanied by a brief description on their first use in the manual.

Example: Provides on-screen anatomical graphics of

indicate the anatomy under evaluation.

Within a procedure, options in the system presets are identified in text as boldface type.

Example: Highlight the Keyboard – Annotation option.

pictograms

that

viii SYSTEM REFERENCE

1 Acoustic Output Reference

Transducer Technical Data and Acoustic Output............................................ 3

Display Resolution and Measurement Accuracy ........................................... 3

Default Displayed MI and TI Values by Transducer .......................................4

Transducers and Intended Applications......................................................... 5

IEC 61157 Acoustic Output Reporting .............................................................. 6

Track 3, FDA 510(k) Acoustic Output Reporting............................................ 15

Summary Table for Acoustic Output ........................................................... 15

Definitions ................................................................................................... 16

SYSTEM REFERENCE 1 - 1

1 Acoustic Output Reference

1 - 2 SYSTEM REFERENCE

1 Acoustic Output Reference

γ

Transducer Technical Data and Acoustic Output

Display Resolution and Measurement Accuracy

For any transducer capable of exceeding a mechanical or thermal index value of 1.0, the ultrasound imaging system displays indices starting from

0.4. The resolution of the display is 0.1 for all displayed values of MI. For all TI values, the resolution of the display is 0.2.

It is important to note that displayed indices are obtained through measurement, and are subject to measurement errors. Specific measurement uncertainties for acoustic power, pressure, and center frequency are 5.4%, 8.5%, and 2.1% respectively. Measurement precision for ultrasonic power, peak rarefactional pressure, and center frequency from a standard test transducer/driver combination is 8.2%, 4.6%, and 1.1% respectively. The reported values assume 90% population (P ) at 90% confidence level ( 1998 AIUM/NEMA document entitled Standard for Real-Time Display of

Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment – Revision 1 (also known as the Output Display Standard).

).Definitions for these parameters can be found in the

SYSTEM REFERENCE 1 - 3

1 Acoustic Output Reference

Default Displayed MI and TI Values by Transducer

(Per transducer/mode that exceeds default MI or TI value of 1.0)

Note: For SONOVISTA systems only: The 3.5C55S transducer is the equivalent of the C6-2 transducer. The 3D-ABD transducer is the equivalent of the C6F3 transducer. The 6.5EV13 transducer is the equivalent of the EV9-4 transducer.

Mode

B M PwD Color cwD

Transducer

P4-2 1.0 1.0 1.0 3.2 2.6 P9-4 1.6 1.0 1.8 2.0 1.2 2.0 L10-5 1.0

7.5L70 1.2

5.0L45 1.2 VF13-5 1.1 1.1 1.2 VF13-5SP 1.0 1.0 1.8 CH5-2 1.4 1.4 2.4 C6-2 1.0 1.0 1.8 C6-3 3D/C6F3

5.0C50+ 1.6 C8-5 1.0 BE9-4 1.0 1.0 EC9-4 EV9-4 1.0 1.0 1.0 CW21 3.0 CW51 1.8

MI TI MI TI MI TI MI TI MI TI

1

Not available for SONOVISTA systems

1 - 4 SYSTEM REFERENCE

1 Acoustic Output Reference

Transducers and Intended Applications

Only the following transducers from Siemens are compatible with the G60 S ultrasound imaging system:

Note: For SONOVISTA systems only: The 3.5C55S transducer is the equivalent of the C6-2 transducer. The 3D-ABD transducer is the equivalent of the C6F3 transducer. The 6.5EV13 transducer is the equivalent of the EV9-4 transducer.

Note: Certain transducers may require features not available on your system. Refer to the Accessories and Options chapter of the System Reference for a list of system-specific features and options, including transducers.

EMC Note: Operating the transducer in close proximity to sources of strong electromagnetic fields, such as radio transmitter stations or similar installations, may lead to temporary degradation or interference visible on the monitor screen. A lightening of image background may be noticed while visualizing hypoechoic structures, or color spectral interference, or jitter, or horizontal lines in the image screen may occur. The transducer and the system have been designed and tested to withstand such interference and will not be permanently damaged. Refer to the Electromagnetic Emissions and Immunity Guidence and Manufacturer's Declaration.

TRANSDUCER NAME

CH5-2

C6-2

C6-3 3D/C6F3 C8-5

5.0C50+ BE9-4

EC9-4 EV9-4

5.0L45

7.5L70

L10-5

VF13-5

VF13-5SP

P9-4

P4-2

CW21

Error! Bookmark

CW5

not defined.

OPERATING FREQUENCY MODES OF OPERATION INTENDED APPLICATIONS

CURVED AND LINEAR ARRAY TRANSDUCERS

2 – 5 MHz B, C, M, PW

2 – 6 MHz B, C, M, PW

2 – 5 MHz B, C, M, PW 5 – 8 MHz B, C, M, PW

3.5 – 7.5 MHz B, C, M, PW TBD – TBD

MHz 4 – 9 MHz B, C, M, PW 4 – 8 MHz B, C, M, PW

3.6 – 6.0 MHz B, C, M, PW

5 – 10 MHz B, C, M, PW

5 – 13 MHz B, C, M, PW

4 – 9 MHz B, C, M, PW, CW

2 – 4 MHz B, C, M, PW, CW

2 MHz CW 5 MHz CW

B, C, M, PW

PHASED ARRAY TRANSDUCERS

CONTINUOUS WAVE TRANSDUCERS

Abdomen, Renal, Obstetrics, Gynecology, Peripheral Vascular

Abdomen, Obstetrics, Gynecology, Pelvic Neonatal Cephalic, Neonatal Abdomen Abdomen, Obstetrics, Gynecology, Pediatric Endorectal, Endovaginal

Prostate, Early Obstetrics, Gynecology Early Obstetrics, Gynecology Peripheral Vascular, Cerebrovascular,

Musculoskeletal, Breast, Thyroid Breast, Thyroid,

Orthopedics, Musculoskeletal Thyroid, Breast, Testis, Cerebrovascular,

Orthopedics, Musculoskeletal Breast, Testis, Thyroid,

Superficial, Musculoskeletal Intraoperative Abdominal, Intraoperative

Neurological, Pediatric, Small Organ, Peripheral Vessel, Musculoskeletal, Superficial Musculoskeletal

Pediatric, Cardiology, Abdomen, Neonatal Cephalic

Adult Cardiology, Abdomen, Renal, Transcranial Imaging

Adult Cardiology Vascular

1

Not available for SONOVISTA systems

SYSTEM REFERENCE 1 - 5

1 Acoustic Output Reference

IEC 61157 Acoustic Output Reporting

Acoustic output information for the G60 S ultrasound imaging system. Phased Array Transducer. Type: P4-2

Manufacturer: Siemens Medical Solutions USA, Inc., Ultrasound Group

Parameter Mode Bp Bi Mp Mi (B+C)p (M+C)i Dp Di CwD

p_ (MPa)

I

(mW/cm2) 540 590 550 560 590 1600 1200 1600 1200

spta

System settings 3.0 MHz 2.1 MHz 3.0 MHz 2.1 MHz

Focus in mm 49 49 49 49 71 84 100 84 60

Output in dB 0 0 0 0 0 0 0 0 0

Ip (mm) 39 36 39 36 56 66 70 67 41

W

(II) (mm) 2.2 2.6 2.2 2.6 2.9 3.3 4.4 2.9 3.8

pb6

(⊥) (mm)

prr (kHz)

srr (Hz)

Output beam dimensions (mm) 14 x 13 14 x 13 14 x 13 14 x 13 20 x 13 20 x 13 20 x 13 20 x 13 9.3 x 13

f

(MHz) 2.5 2.1 2.5 2.1 2.1 2.6 2.1 2.6 2.5

awf

APF a (%)

AIF b (%)

Maximum power (mW) 340 410 51 61 69 250 250 190 150

I

(mW/cm2) 180 220 27 33 27 96 98 73 130

ob

Power-up mode B B B B B B B B B

Initialization mode n/a n/a n/a n/a n/a n/a n/a n/a n/a

Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes

Itt (mm) n/a n/a n/a n/a n/a n/a n/a n/a n/a

Its (mm) contact contact contact contact contact contact contact contact Contact

Inclusive modes - - B+M B+M M+C,

a Acoustic power-up fraction

b Acoustic initialization fraction

Acoustic output information for the G60 S ultrasound imaging system. Phased Array Transducer. Type: P9-4

Manufacturer: Siemens Medical Solutions USA, Inc., Ultrasound Group

Parameter Mode Bp Bi Mp Mi (M+C)p (M+C)i Dp Di CwD

p_ (MPa)

I

(mW/cm2) 88 190 180 260 920 1800 1300 1900 1600

spta

System settings 8.0 MHz 4.0 MHz 8.0 MHz 4.0 MHz

Focus in mm 19 35 19 35 35 50 42 50 29

Output in dB 0 0 0 0 0 0 0 0 0

Ip (mm) 13 26 13 26 31 43 34 43 33

W

(II) (mm) 1.0 1.9 1.0 1.9 1.3 1.6 1.7 1.6 2.2

pb6

(⊥) (mm)

prr (kHz)

srr (Hz)

Output beam dimensions (mm) 4.6 x 8.0 6.0 x 8.0 4.6 x 8.0 6.0 x 8.0 6.7 x 8.0 7.7 x 8.0 7.7 x 8.0 7.7 x 8.0 3.6 x 8.0

f

(MHz) 5.5 4.2 5.5 4.2 5.3 5.3 5.3 5.3 5.1

awf

APF a (%)

AIF b (%)

Maximum power (mW) 59 79 13 18 26 66 50 69 74

I

(mW/cm2) 160 160 36 37 48 110 81 110 260

ob

Power-up mode B B B B B B B B B

Initialization mode n/a n/a n/a n/a n/a n/a n/a n/a n/a

Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes

Itt (mm) n/a n/a n/a n/a n/a n/a n/a n/a n/a

Its (mm) contact contact contact contact contact contact contact contact contact

Inclusive modes - - B+M B+M B+C,B+C

a Acoustic power-up fraction

b Acoustic initialization fraction

Acoustic output information is presented according to the recommendations of the International Electrotechnical Commission (IEC) as expressed in IEC 61157.

3.3 2.6 3.3 2.6 2.9 1.8 2.4 1.2 0.17

3.6 3.6 3.6 3.6 3.4 4.0 4.1 3.5 2.9

4.5 4.5 1.0 1.0 1.0 4.1 1.3 15.2 -

118 118 - - - - - - -

n/a n/a n/a n/a n/a n/a n/a n/a n/a

B+C+D

3.7 2.5 3.7 2.5 3.5 1.7 2.8 1.9 0.19

5.9 2.9 5.9 2.9 1.9 1.9 1.9 1.9 1.8

3.0 3.0 1.0 1.0 1.9 12.5 1.3 5.8 -

78 78 - - - - - - -

n/a n/a n/a n/a n/a n/a n/a n/a n/a

+D

B+C,

B+C+D

B+C,B+C

+D

B+D,

B+M+D

B+D,B+M

+D

B+D,

B+M+D

B+D,B+M

+D

-

1 - 6 SYSTEM REFERENCE

1 Acoustic Output Reference

Acoustic output information for the G60 S ultrasound imaging system. Linear Array Transducer. Type: L10-5

Manufacturer: Siemens Medical Solutions USA, Inc., Ultrasound Group

Parameter Mode Bp Bi Mp Mi (B+C)p (M+C)i Dp Di

p_ (MPa)

I

(mW/cm2) 64 99 100 140 140 1300 820 1300

spta

System settings 10.0 MHz 6.5 MHz 10.0 MHz 6.5 MHz

Focus in mm 26 26 26 26 26 26 26 26

Output in dB 0 0 0 0 0 0 0 0

Ip (mm) 19 20 19 20 19 20 19 20

W

(II) (mm) 1.1 1.3 1.1 1.3 1.2 1.1 1.2 1.1

pb6

(⊥) (mm)

prr (kHz)

srr (Hz)

Output beam dimensions (mm) 5.7 x 5.0 5.7 x 5.0 5.7 x 5.0 5.7 x 5.0 5.7 x 5.0 5.7 x 5.0 5.7 x 5.0 5.7 x 5.0

f

(MHz) 5.7 5.6 5.7 5.6 5.2 7.0 5.2 7.0

awf

APF a (%)

AIF b (%)

Maximum power (mW) 12 24 1.8 3.5 3.2 19 19 18

I

(mW/cm2) 40 80 6.1 12 11 65 65 63

ob

Power-up mode B B B B B B B B

Initialization mode n/a n/a n/a n/a n/a n/a n/a n/a

Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes

Itt (mm) n/a n/a n/a n/a n/a n/a n/a n/a

Its (mm) contact contact contact contact contact contact contact contact

Inclusive modes - - B+M B+M M+C,

a Acoustic power-up fraction

b Acoustic initialization fraction

2.4 2.1 2.4 2.1 3.3 1.8 2.7 1.4

1.3 1.7 1.3 1.7 1.6 1.1 1.6 1.1

4.5 4.5 1.0 1.0 1.3 7.6 1.3 15.2

94 94 - - - - - -

n/a n/a n/a n/a n/a n/a n/a n/a

B+C+D

B+C,

B+C+D

B+D,

B+M+D

B+D,

B+M+D

Acoustic output information for the G60 S ultrasound imaging system. Linear Array Transducer. Type: 7.5L70

Manufacturer: Siemens Medical Solutions USA, Inc., Ultrasound Group

Parameter Mode Bp Bi Mp Mi (M+C)p (M+C)i Dp Di

p_ (MPa)

I

(mW/cm2) 58 120 150 250 700 1500 710 1500

spta

System settings 6.0 MHz 7.5 MHz 6.0 MHz 7.5 MHz

Focus in mm 20 25 20 25 25 30 17 30

Output in dB 0 0 0 0 0 0 0 0

Ip (mm) 13 16 13 16 18 23 14 23

(II) (mm) 1.1 1.5 1.1 1.5 1.1 1.1 1.3 1.1

W

pb6

(⊥) (mm)

prr (kHz)

srr (Hz)

Output beam dimensions (mm) 5.0 x 5.0 6.5 x 5.0 5.0 x 5.0 6.5 x 5.0 6.5 x 5.0 7.9 x 5.0 4.3 x 5.0 7.9 x 5.0

f

(MHz) 6.4 6.0 6.4 6.0 7.0 7.0 5.2 7.0

awf

APF a (%)

AIF b (%)

Maximum power (mW) 18 33 2.6 4.9 9.3 23 13 23

I

(mW/cm2) 71 100 10 15 29 57 61 57

ob

Power-up mode B B B B B B B B

Initialization mode n/a n/a n/a n/a n/a n/a n/a n/a

Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes

Itt (mm) n/a n/a n/a n/a n/a n/a n/a n/a

Its (mm) contact contact contact contact contact contact contact contact

Inclusive modes - - B+M B+M B+C,

a Acoustic power-up fraction

b Acoustic initialization fraction

3.5 2.9 3.5 2.9 3.3 1.8 3.0 1.8

1.4 1.1 1.4 1.1 1.0 1.1 1.2 1.1

4.5 4.5 1.0 1.0 1.3 8.7 1.3 10

94 94 - - - - - -

n/a n/a n/a n/a n/a n/a n/a n/a

B+C+D

B+C,

B+C+D

B+D,

B+M+D

B+D,

B+M+D

Acoustic output information is presented according to the recommendations of the International Electrotechnical Commission (IEC) as expressed in IEC 61157.

SYSTEM REFERENCE 1 - 7

1 Acoustic Output Reference

Acoustic output information for the G60 S ultrasound imaging system. Linear Array Transducer. Type: VF13-5

Manufacturer: Siemens Medical Solutions USA, Inc., Ultrasound Group

Parameter Mode Bp Bi Mp Mi (B+C)p (M+C)i Dp Di

p_ (MPa)

I

(mW/cm2) 81 94 130 170 110 990 520 1000

spta

System settings 12.0 MHz 8.0 MHz 12.0 MHz 8.0 MHz

Focus in mm 15 12 15 12 12 21 5.0 21

Output in dB 0 0 0 0 0 0 0 0

Ip (mm) 7.0 6.0 7.0 6.0 6.0 13 4.0 13

W

(II) (mm) 1.1 1.0 1.1 1.0 1.0 1.1 1.1 1.1

pb6

(⊥) (mm)

prr (kHz)

srr (Hz)

Output beam dimensions (mm) 4.0 x 2.5 3.2 x 2.5 4.0 x 2.5 3.2 x 2.5 3.2 x 2.5 5.6 x 2.5 1.6 x 2.5 5.6 x 2.5

f

(MHz) 7.5 7.3 7.5 7.3 7.0 7.0 7.0 7.0

awf

APF a (%)

AIF b (%)

Maximum power (mW) 13 15 1.9 2.2 1.4 22 8.3 22

I

(mW/cm2) 130 190 19 27 17 160 210 160

ob

Power-up mode B B B B B B B B

Initialization mode n/a n/a n/a n/a n/a n/a n/a n/a

Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes

Itt (mm) n/a n/a n/a n/a n/a n/a n/a n/a

Its (mm) contact contact contact contact contact contact contact contact

Inclusive modes - - B+M B+M M+C,

a Acoustic power-up fraction

b Acoustic initialization fraction

3.7 3.0 3.7 3.0 3.6 1.8 3.4 1.4

1.1 1.1 1.1 1.1 1.1 1.7 1.3 1.7

4.5 4.5 1.0 1.0 1.0 6.6 1.3 15.2

94 94 - - - - - -

n/a n/a n/a n/a n/a n/a n/a n/a

B+C+D

B+C,

B+C+D

B+D,

B+M+D

B+D,

B+M+D

Acoustic output information for the G60 S ultrasound imaging system. Linear Array Transducer. Type: VF13-5SP

Manufacturer: Siemens Medical Solutions USA, Inc., Ultrasound Group

Parameter Mode Bp Bi Mp Mi (B+C)p (M+C)i Dp Di

p_ (MPa)

I

(mW/cm2) 81 130 130 220 110 990 520 1000

spta

System settings 12.0 MHz 8.0 MHz 12.0 MHz 8.0 MHz

Focus in mm 15 12 15 12 12 21 5.0 21

Output in dB 0 0 0 0 0 0 0 0

Ip (mm) 7.0 6.0 7.0 6.0 6.0 13 4.0 13

W

(II) (mm) 1.1 1.0 1.1 1.0 1.0 1.1 1.1 1.1

pb6

(⊥) (mm)

prr (kHz)

srr (Hz)

Output beam dimensions (mm) 4.0 x 2.5 3.2 x 2.5 4.0 x 2.5 3.2 x 2.5 3.2 x 2.5 5.6 x 2.5 1.6 x 2.5 5.6 x 2.5

f

(MHz) 7.5 7.3 7.5 7.3 7.0 7.0 7.0 7.0

awf

APF a (%)

AIF b (%)

Maximum power (mW) 13 20 1.9 3.0 1.4 22 8.3 22

I

(mW/cm2) 130 250 19 37 17 160 210 160

ob

Power-up mode B B B B B B B B

Initialization mode n/a n/a n/a n/a n/a n/a n/a n/a

Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes

Itt (mm) n/a n/a n/a n/a n/a n/a n/a n/a

Its (mm) contact contact contact contact contact contact contact contact

Inclusive modes - - B+M B+M M+C,

a Acoustic power-up fraction

b Acoustic initialization fraction

3.7 3.4 3.7 3.4 3.6 1.8 3.4 1.4

1.1 1.1 1.1 1.1 1.1 1.7 1.3 1.7

4.5 4.5 1.0 1.0 1.0 6.6 1.3 15.2

94 94 - - - - - -

n/a n/a n/a n/a n/a n/a n/a n/a

B+C+D

B+C,

B+C+D

B+D,

B+M+D

B+D,

B+M+D

Acoustic output information is presented according to the recommendations of the International Electrotechnical Commission (IEC) as expressed in IEC 61157.

1 - 8 SYSTEM REFERENCE

1 Acoustic Output Reference

Acoustic output information for the G60 S ultrasound imaging system. Curved Array Transducer. Type: 5.0L45

Manufacturer: Siemens Medical Solutions USA, Inc., Ultrasound Group

Parameter Mode Bp Bi Mp Mi (M+C)p (M+C)i Dp Di

p_ (MPa)

I

(mW/cm2) 170 240 210 230 900 1500 900 1300

spta

System settings 5.0 MHz 4.0 MHz 5.0 MHz 4.0 MHz

Focus in mm 29 35 29 35 29 42 29 42

Output in dB 0 0 0 0 0 0 0 0

Ip (mm) 20 23 20 23 23 30 23 30

W

(II) (mm) 1.5 1.8 1.5 1.8 1.3 1.7 1.3 1.7

pb6

(⊥) (mm)

prr (kHz)

srr (Hz)

Output beam dimensions (mm) 6.8 x 7.0 8.1 x 7.0 6.8 x 7.0 8.1 x 7.0 6.8 x 7.0 9.3 x 7.0 6.8 x 7.0 9.3 x 7.0

f

(MHz) 5.1 3.9 5.1 3.9 5.2 5.2 5.2 5.2

awf

APF a (%)

AIF b (%)

Maximum power (mW) 36 52 5.4 7.8 15 42 15 38

I

(mW/cm2) 76 93 11 14 31 65 31 59

ob

Power-up mode B B B B B B B B

Initialization mode n/a n/a n/a n/a n/a n/a n/a n/a

Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes

Itt (mm) n/a n/a n/a n/a n/a n/a n/a n/a

Its (mm) contact contact contact contact contact contact contact contact

Inclusive modes - - B+M B+M B+C,

a Acoustic power-up fraction

b Acoustic initialization fraction

3.2 2.9 3.2 2.9 3.0 1.6 3.0 1.5

1.5 1.5 1.5 1.5 1.1 1.4 1.1 1.4

4.5 4.5 1.0 1.0 1.3 6.9 1.3 8.6

136 136 - - - - - -

n/a n/a n/a n/a n/a n/a n/a n/a

B+C+D

B+C,

B+C+D

B+D,

B+M+D

B+D,

B+M+D

Acoustic output information for the G60 S ultrasound imaging system. Curved Array Transducer. Type: C6-2

Manufacturer: Siemens Medical Solutions USA, Inc., Ultrasound Group

Parameter Mode Bp Bi Mp Mi (M+C)p (M+C)i Dp Di

p_ (MPa)

I

(mW/cm2) 100 100 180 180 720 1700 610 1200

spta

System settings 5.0 MHz 5.0 MHz 5.0 MHz 5.0 MHz

Focus in mm 73 73 73 73 86 73 86 73

Output in dB 0 0 0 0 0 0 0 0

Ip (mm) 44 44 44 44 57 50 57 50

W

(II) (mm) 2.9 2.9 2.9 2.9 3.0 2.7 3.0 2.7

pb6

(⊥) (mm)

prr (kHz)

srr (Hz)

Output beam dimensions (mm) 11 x 11 11 x 11 11 x 11 11 x 11 13 x 11 11 x 11 13 x 11 11 x 11

f

(MHz) 3.3 3.3 3.3 3.3 3.5 3.5 3.5 3.5

awf

APF a (%)

AIF b (%)

Maximum power (mW) 210 210 32 32 79 190 66 130

I

(mW/cm2) 180 180 27 27 55 160 47 110

ob

Power-up mode B B B B B B B B

Initialization mode n/a n/a n/a n/a n/a n/a n/a n/a

Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes

Itt (mm) n/a n/a n/a n/a n/a n/a n/a n/a

Its (mm) contact contact contact contact contact contact contact contact

Inclusive modes - - B+M B+M B+C,

a Acoustic power-up fraction

b Acoustic initialization fraction

2.7 2.7 2.7 2.7 2.6 1.5 2.4 1.2

5.1 5.1 5.1 5.1 3.1 3.4 3.1 3.4

4.5 4.5 1.0 1.0 1.3 7.6 1.3 8.6

94 94 - - - - - -

n/a n/a n/a n/a n/a n/a n/a n/a

B+C+D

B+C,

B+C+D

B+D,

B+M+D

B+D,

B+M+D

Acoustic output information is presented according to the recommendations of the International Electrotechnical Commission (IEC) as expressed in IEC 61157.

SYSTEM REFERENCE 1 - 9

1 Acoustic Output Reference

Acoustic output information for the G60 S ultrasound imaging system. Curved Array Transducer. Type: CH5-2

Manufacturer: Siemens Medical Solutions USA, Inc., Ultrasound Group

Parameter Mode Bp Bi Mp Mi (M+C)p (M+C)i Dp Di CwD

p_ (MPa)

I

(mW/cm2) 140 170 200 220 710 1300 820 1300 140

spta

System settings 5.0 MHz 4.0 MHz 5.0 MHz 4.0 MHz 5.0 MHz

Focus in mm 73 73 73 73 73 86 86 86 73

Output in dB 0 0 0 0 0 0 0 0 0

Ip (mm) 50 50 50 50 55 61 61 61 50

W

(II) (mm) 3.2 3.6 3.2 3.6 2.8 3.2 3.2 3.2 3.2

pb6

(⊥) (mm)

prr (kHz)

srr (Hz)

Output beam dimensions (mm) 13 x 14 13 x 14 13 x 14 13 x 14 13 x 14 16 x 14 13 x 14 16 x 14 13 x 14

f

(MHz) 2.7 2.1 2.7 2.1 2.6 2.6 2.6 2.6 2.7

awf

APF a (%)

AIF b (%)

Maximum power (mW) 190 240 29 35 83 180 110 170 190

I

(mW/cm2) 100 130 15 19 44 80 48 73 100

ob

Power-up mode B B B B B B B B B

Initialization mode n/a n/a n/a n/a n/a n/a n/a n/a n/a

Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes Yes

Itt (mm) n/a n/a n/a n/a n/a n/a n/a n/a n/a

Its (mm) contact contact contact contact contact contact contact contact contact

Inclusive modes - - B+M B+M B+C,B+C

a Acoustic power-up fraction

b Acoustic initialization fraction

2.3 1.5 2.3 1.5 2.3 1.7 2.6 1.8 2.3

3.8 3.9 3.8 3.9 3.5 3.5 3.5 3.5 3.8

4.5 4.5 1.0 1.0 1.0 4.4 1.4 4.1 4.5

155 155 - - - - - - 155

n/a n/a n/a n/a n/a n/a n/a n/a n/a

+D

B+C,B+C

+D

B+D,B+M

+D

B+D,B+M

+D

-

Acoustic output information for the G60 S ultrasound imaging system. Curved Array Transducer. Type: C6-3 3D/C6F3

Manufacturer: Siemens Medical Solutions USA, Inc., Ultrasound Group

Parameter Mode Bp Bi Mp Mi (M+C)p (M+C)i Dp Di

p_ (MPa)

I

(mW/cm2) 19 21 120 140 470 860 500 820

spta

System settings 3.5 MHz 3.5 MHz 3.5 MHz 3.5 MHz

Focus in mm 73 73 73 73 51 61 51 61

Output in dB 0 0 0 0 0 0 0 0

Ip (mm) 52 53 52 53 46 54 46 54

W

(II) (mm) 2.6 2.7 2.6 2.7 2.3 2.3 2.3 2.3

pb6

(⊥) (mm)

prr (kHz)

srr (Hz)

Output beam dimensions (mm) 15 x 11 15 x 11 15 x 11 15 x 11 15 x 11 13 x 11 12 x 11 13 x 11

f

(MHz) 3.1 3.1 3.1 3.1 3.5 3.5 3.5 3.5

awf

APF a (%)

AIF b (%)

Maximum power (mW) 73 91 11 13 39 70 42 67

I

(mW/cm2) 44 54 6.5 8.0 30 49 32 46

ob

Power-up mode B B B B B B B B

Initialization mode n/a n/a n/a n/a n/a n/a n/a n/a

Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes

Itt (mm) n/a n/a n/a n/a n/a n/a n/a n/a

Its (mm) contact contact contact contact contact contact contact contact

Inclusive modes - - B+M B+M B+C,

a Acoustic power-up fraction

b Acoustic initialization fraction

2.1 2.0 2.1 2.0 1.8 1.4 1.9 1.4

3.1 3.1 3.1 3.1 3.0 3.0 3.0 3.0

4.5 4.5 1.0 1.0 1.3 3.3 1.3 3.3

47 47 - - - - - -

n/a n/a n/a n/a n/a n/a n/a n/a

B+C+D

B+C,

B+C+D

B+D,

B+M+D

B+D,

B+M+D

Acoustic output information is presented according to the recommendations of the International Electrotechnical Commission (IEC) as expressed in IEC 61157.

1 - 10 SYSTEM REFERENCE

1 Acoustic Output Reference

Acoustic output information for the G60 S ultrasound imaging system. Curved Array Transducer. Type: 5.0C50+

Manufacturer: Siemens Medical Solutions USA, Inc., Ultrasound Group

Parameter Mode Bp Bi Mp Mi (M+C)p (M+C)i Dp Di

p_ (MPa)

I

(mW/cm2) 100 100 250 250 1200 2800 1200 2700

spta

System settings 3.5 MHz 3.5 MHz 3.5 MHz 3.5 MHz

Focus in mm 51 51 51 51 61 61 61 61

Output in dB 0 0 0 0 0 0 0 0

Ip (mm) 44 44 44 44 49 49 49 51

W

(II) (mm) 1.9 1.9 1.9 1.9 2.2 2.2 2.2 1.5

pb6

(⊥) (mm)

prr (kHz)

srr (Hz)

Output beam dimensions (mm) 12 x 11 12 x 11 12 x 11 12 x 11 13 x 11 13 x 11 13 x 11 13 x 11

f

(MHz) 4.0 4.0 4.0 4.0 3.5 5.2 3.5 5.2

awf

APF a (%)

AIF b (%)

Maximum power (mW) 86 86 13 13 65 160 67 79

I

(mW/cm2) 102 102 15 15 44 110 45 53

ob

Power-up mode B B B B B B B B

Initialization mode n/a n/a n/a n/a n/a n/a n/a n/a

Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes

Itt (mm) n/a n/a n/a n/a n/a n/a n/a n/a

Its (mm) contact contact contact contact contact contact contact contact

Inclusive modes - - B+M B+M B+C,

a Acoustic power-up fraction

b Acoustic initialization fraction

3.0 3.0 3.0 3.0 2.8 1.7 2.9 1.7

2.3 2.3 2.3 2.3 2.2 2.2 2.2 1.6

4.5 4.5 1.0 1.0 1.3 12.5 1.3 12.5

94 94 - - - - - -

n/a n/a n/a n/a n/a n/a n/a n/a

B+C+D

B+C,

B+C+D

B+D,

B+M+D

B+D,

B+M+D

Acoustic output information for the G60 S ultrasound imaging system. Curved Array Transducer. Type: C8-5

Manufacturer: Siemens Medical Solutions USA, Inc., Ultrasound Group

Parameter Mode Bp Bi Mp Mi (M+C)p (M+C)i Dp Di

p_ (MPa)

I

(mW/cm2) 150 150 290 290 780 1300 880 1400

spta

System settings 5.0 MHz 5.0 MHz 5.0 MHz 5.0 MHz

Focus in mm 23 23 23 23 19 40 27 40

Output in dB 0 0 0 0 0 0 0 0

Ip (mm) 15 15 15 15 16 30 20 30

W

(II) (mm) 1.4 1.4 1.4 1.4 1.2 1.3 1.2 1.3

pb6

(⊥) (mm)

prr (kHz)

srr (Hz)

Output beam dimensions (mm) 6.2 x 5.0 6.2 x 5.0 6.2 x 5.0 6.2 x 5.0 5.2 x 5.0 10 x 5.0 7.1 x 5.0 10 x 5.0

f

(MHz) 4.7 4.7 4.7 4.7 5.2 5.2 5.2 5.2

awf

APF a (%)

AIF b (%)

Maximum power (mW) 40 40 5.9 5.9 13 44 16 48

I

(mW/cm2) 130 130 19 19 49 85 45 92

ob

Power-up mode B B B B B B B B

Initialization mode n/a n/a n/a n/a n/a n/a n/a n/a

Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes

Itt (mm) n/a n/a n/a n/a n/a n/a n/a n/a

Its (mm) contact contact contact contact contact contact contact contact

Inclusive modes - - B+M B+M B+C,

a Acoustic power-up fraction

b Acoustic initialization fraction

3.4 3.4 3.4 3.4 3.0 1.4 3.0 1.3

1.3 1.3 1.3 1.3 1.1 2.2 1.4 2.2

4.5 4.5 1.0 1.0 1.3 10.4 1.3 16.7

110 110 - - - - - -

n/a n/a n/a n/a n/a n/a n/a n/a

B+C+D

B+C,

B+C+D

B+D,

B+M+D

B+D,

B+M+D

Acoustic output information is presented according to the recommendations of the International Electrotechnical Commission (IEC) as expressed in IEC 61157.

SYSTEM REFERENCE 1 - 11

1 Acoustic Output Reference

Acoustic output information for the G60 S ultrasound imaging system. Curved Array Transducer. Type: EC9-4

Manufacturer: Siemens Medical Solutions USA, Inc., Ultrasound Group

Parameter Mode Bp Bi Mp Mi (M+C)p (M+C)i Dp Di

p_ (MPa)

I

(mW/cm2) 85 100 140 170 830 1200 860 1200

spta

System settings 6.5 MHz 4.2 MHz 6.5 MHz 4.2 MHz

Focus in mm 21 21 21 21 26 37 26 21

Output in dB 0 0 0 0 0 0 0 0

Ip (mm) 15 15 15 15 18 23 18 18

W

(II) (mm) 1.6 1.5 1.6 1.5 1.6 2.3 1.6 1.1

pb6

(⊥) (mm)

prr (kHz)

srr (Hz)

Output beam dimensions (mm) 5.3 x 5.0 5.3 x 5.0 5.3 x 5.0 5.3 x 5.0 5.7 x 5.0 7.4 x 5.0 5.7 x 5.0 5.3 x 5.0

f

(MHz) 5.0 4.8 5.0 4.8 5.2 5.2 5.2 7.0

awf

APF a (%)

AIF b (%)

Maximum power (mW) 30 31 4.4 4.6 23 53 24 18

I

(mW/cm2) 110 120 17 17 81 140 83 68

ob

Power-up mode B B B B B B B B

Initialization mode n/a n/a n/a n/a n/a n/a n/a n/a

Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes

Itt (mm) n/a n/a n/a n/a n/a n/a n/a n/a

Its (mm) contact contact contact contact contact contact contact contact

Inclusive modes - - B+M B+M B+C,

a Acoustic power-up fraction

b Acoustic initialization fraction

2.5 2.4 2.5 2.4 3.2 2.0 3.2 1.8

1.7 1.6 1.7 1.6 1.5 1.6 1.5 1.2

4.5 4.5 1.0 1.0 1.3 3.8 1.3 7.1

155 155 - - - - - -

n/a n/a n/a n/a n/a n/a n/a n/a

B+C+D

B+C,

B+C+D

B+D,

B+M+D

B+D,

B+M+D

Acoustic output information for the G60 S ultrasound imaging system. Curved Array Transducer. Type: EV9-4

Manufacturer: Siemens Medical Solutions USA, Inc., Ultrasound Group

Parameter Mode Bp Bi Mp Mi (M+C)p (M+C)i Dp Di

p_ (MPa)

I

(mW/cm2) 91 95 220 220 900 1400 610 1400

spta

System settings 6.5 MHz 5.5 MHz 6.5 MHz 5.5 MHz

Focus in mm 33 23 33 23 23 27 27 27

Output in dB 0 0 0 0 0 0 0 0

Ip (mm) 21 18 21 18 20 22 22 22

W

(II) (mm) 1.6 1.3 1.6 1.3 1.4 1.1 1.1 1.1

pb6

(⊥) (mm)

prr (kHz)

srr (Hz)

Output beam dimensions (mm) 6.8 x 6.0 5.4 x 6.0 6.8 x 6.0 5.4 x 6.0 5.4 x 6.0 6.1 x 6.0 6.1 x 6.0 6.1 x 6.0

f

(MHz) 5.2 5.2 5.2 5.2 5.2 7.0 7.0 7.0

awf

APF a (%)

AIF b (%)

Maximum power (mW) 39 30 5.8 4.5 19 19 8.4 19

I

(mW/cm2) 100 90 14 14 59 50 23 51

ob

Power-up mode B B B B B B B B

Initialization mode n/a n/a n/a n/a n/a n/a n/a n/a

Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes

Itt (mm) n/a n/a n/a n/a n/a n/a n/a n/a

Its (mm) contact contact contact contact contact contact contact contact

Inclusive modes - - B+M B+M B+C,

a Acoustic power-up fraction

b Acoustic initialization fraction

3.2 2.4 3.2 2.4 3.0 1.9 3.0 1.9

1.5 1.3 1.5 1.3 1.3 1.0 1.0 1.0

4.5 4.5 1.0 1.0 1.3 7.6 1.3 8.6

94 94 - - - - - -

n/a n/a n/a n/a n/a n/a n/a n/a

B+C+D

B+C,

B+C+D

B+D,

B+M+D

B+D,

B+M+D

Acoustic output information is presented according to the recommendations of the International Electrotechnical Commission (IEC) as expressed in IEC 61157.

1 - 12 SYSTEM REFERENCE

1 Acoustic Output Reference

Acoustic output information for the G60 S ultrasound imaging system. Curved Array Transducer. Type: BE9-4

Manufacturer: Siemens Medical Solutions USA, Inc., Ultrasound Group

Parameter Mode Bp Bi Mp Mi (B+C)p (M+C)i Dp Di

p_ (MPa)

I

(mW/cm2) 64 66 110 140 73 970 470 800

spta

System settings 9.0 MHz 6.5 MHz 9.0 MHz 6.5 MHz

Focus in mm 26 21 26 21 21 21 14 21

Output in dB 0 0 0 0 0 0 0 0

Ip (mm) 17 15 17 15 19 17 14 17

W

(II) (mm) 1.2 1.1 1.2 1.1 1.1 1.1 1.3 1.1

pb6

(⊥) (mm)

prr (kHz)

srr (Hz)

Output beam dimensions (mm) 5.6 x 4.3 5.2 x 4.3 5.6 x 4.3 5.2 x 4.3 5.2 x 4.3 5.2 x 4.3 4.0 x 4.3 5.2 x 4.3

f

(MHz) 5.4 5.2 5.4 5.2 7.0 5.2 5.2 5.2

awf

APF a (%)

AIF b (%)

Maximum power (mW) 18 20 2.7 3.0 1.4 22 14 18

I

(mW/cm2) 76 90 11 13 6.2 97 79 79

ob

Power-up mode B B B B B B B B

Initialization mode n/a n/a n/a n/a n/a n/a n/a n/a

Acoustic output freeze Yes Yes Yes Yes Yes Yes Yes Yes

Itt (mm) n/a n/a n/a n/a n/a n/a n/a n/a

Its (mm) contact contact contact contact contact contact contact contact

Inclusive modes - - B+M B+M M+C,

a Acoustic power-up fraction

b Acoustic initialization fraction

2.8 2.6 2.8 2.6 2.8 1.9 2.6 1.9

1.7 1.6 1.7 1.6 1.5 1.7 1.9 1.7

4.5 4.5 1.0 1.0 1.3 3.4 1.3 3.3

155 155 - - - - - -

n/a n/a n/a n/a n/a n/a n/a n/a

B+C+D

B+C,

B+C+D

B+D,

B+M+D

B+D,

B+M+D

Acoustic output information is presented according to the recommendations of the International Electrotechnical Commission (IEC) as expressed in IEC 61157.

SYSTEM REFERENCE 1 - 13

1 Acoustic Output Reference

Acoustic output information for the G60 S ultrasound imaging system. Continuous Wave Transducer. Type: CW2

Manufacturer: Siemens Medical Solutions USA, Inc., Ultrasound Group

Parameter Mode cwD

p_ (MPa)

I

(mW/cm2) 860

spta

System settings

Focus in mm 55

Output in dB 0

Ip (mm) 31

W

(II) (mm) 6.0

pb6

(⊥) (mm)

prr (kHz)

srr (Hz)

Output beam dimensions (mm) 13φ

f

(MHz) 2.2

awf

APF a (%)

AIF b (%)

Maximum power (mW) 290

I

(mW/cm2) 150

ob

Power-up mode CW

Initialization mode n/a

Acoustic output freeze Yes

Itt (mm) n/a

Its (mm) contact

Inclusive modes -

a Acoustic power-up fraction

b Acoustic initialization fraction

0.15

4.8

-

n/a

Acoustic output information for the G60 S ultrasound imaging system. Continuous Wave Transducer. Type: CW5

Manufacturer: Siemens Medical Solutions USA, Inc., Ultrasound Group

Parameter Mode cwD

p_ (MPa)

I

(mW/cm2) 1000

spta

System settings

Focus in mm 45

Output in dB 0

Ip (mm) 29

W

(II) (mm) 2.3

pb6

(⊥) (mm)

prr (kHz)

srr (Hz)

Output beam dimensions (mm) 10φ

f

(MHz) 5.1

awf

APF a (%)

AIF b (%)

Maximum power (mW) 79

I

(mW/cm2) 79

ob

Power-up mode CW

Initialization mode n/a

Acoustic output freeze Yes

Itt (mm) n/a

Its (mm) contact

Inclusive modes -

a Acoustic power-up fraction

b Acoustic initialization fraction

0.16

2.9

-

n/a

Acoustic output information is presented according to the recommendations of the International Electrotechnical Commission (IEC) as expressed in IEC 61157.

1 - 14 SYSTEM REFERENCE

1 Acoustic Output Reference

Track 3, FDA 510(k) Acoustic Output Reporting

Data presented in Track 3 format represents the average MI/TI values for five transducers measured under worst-case acoustic output conditions. The on-screen MI/TI values are based on measurements on one transducer under worst case acoutstic output conditions - 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 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 format acoustic output table is supplied for each transducer/mode combination marked with an "X".

Operating Mode Transducer Model

P4-2

P9-4

L10-5

7.5L70

VF13-5

VF13-5SP

5.0L45

C6-2

CH5-2

C6-3 3D/C6F3

5.0C50+

C8-5

EC9-4

BE9-4

EV9-4

CW2

B-mode (2D) M-mode Pulsed Doppler Color Flow

or Power CW Doppler

X X X X X X X X X X X XXXXXX X

X X XX X X X XXXXXXXX

X X

X X X X X X X X X X X X

The following rules apply to the summary table:

X X

X

CW5

X X

System Reference

IEC 61157 1-6

B-mode (2D) No other mode active.

Only MI (when larger than 1.0) is reported for this mode. M-mode Includes simultaneous B-mode. PW-Doppler In duplex modes, the largest displayed TIS (scanned or non-scanned)

is reported if it is larger than 1.0. Color Flow

or Power

Other The output is reported as a separate mode if the largest formulation

Includes simultaneous color flow M-mode, B-mode, and Doppler.

In combined modes, the largest displayed TIS (scanned or

non-scanned) is reported if it is larger than 1.0.

of TIS, TIB, or TIC (if an intended use) is greater than the

corresponding value reported for all constituent mode.

TIC is reported if the transducer is intended for transcranial or

neonatal cephalic use.

SYSTEM REFERENCE 1 - 15

1 Acoustic Output Reference

Definitions

Symbol Definition Units

MI Mechanical Index N/A TIS Scan Soft Tissue Thermal Index in autoscanning mode N/A TIS Non-scan Soft Tissue Thermal Index in non-autoscanning mode N/A TIB Bone Thermal Index N/A TIC Cranial Thermal Index N/A A

Area of the active aperture cm2

aprt

P

r.3

Wo

W

)

.

3(Z1

I

) Derated spatial-peak, temporal-average intensity at axial distance Z1.

TA.3(Z1

Z1

Zbp Zsp For MI: axial distance at which P

deq (Zsp) Equivalent beam diameter as a function of axial distance, and is equal to

fc Center frequency MHz Dim. of A

aprt PD Pulse duration PRF Pulse repetition frequency Hz Pr @ PII

d eq@ PII

Peak rarefactional pressure at the point where the free-field, spatial-peak

max

FL Focal Length, or azimuthal and elevational lengths, if different cm I

@ MI

pa.3

max

Derated peak rarefactional pressure MPa

Ultrasonic power, except for TIS Scan, in which case it is the ultrasonic

mW

power passing through a one centimeter window. Derated ultrasonic power at axial distance Z

mW

1

mW/cm

Axial distance corresponding to the location of the max

[W

), I

.

3(Z1

1.69 (A

(Z) x 1 cm2)], where Z > Zbp.

TA.3

1/2

)

.

aprt

is measured

r.3

For TIB: axial distance at which TIB is a maximum (i.e., Z

sp

= Z

B.3

)

cm2

cm cm

cm

where ITA (Z) is the temporal-average intensity as a function of Z

Active aperture dimensions for the azimuth and elevational planes cm

μs

MPa

pulse intensity integral is a maximum

Equivalent beam diameter at the point where the free-field, spatial-peak

cm

pulse intensity integral is a maximum

Derated pulse-average intensity at the point of global maximum W/cm2

2

1 - 16 SYSTEM REFERENCE

1 Acoustic Output Reference

Acoustic Output Reporting Table – Track 3, FDA 510(k)

(Per transducer/mode that exceeds MI or TI value of 1.0)

Transducer model: P4-2 Operating mode: B-mode

Associated Acoustic Parameters

Maximum Value --- 1.5 (a) (a) (a) (a) (a)

min of [W.3(Z1), ITA.3(Z1)] (mW) #

deq (Zsp) (cm) #

Dim. of Aaprt X (cm) # # # # #

Other information

Pr @ PII max (MPa) 3.3

d eq@ PII max (cm) # #

Focal Length FLx (cm) # # # #

I pa.3 @ MI max (W/cm2) 570

Operator Control

MI TIS TIB TIC

Index Label Scan Non-scan Non-scan

Pr.3 (MPa) 2.4

Wo (mW) # # # #

Z1 (cm) #

Zbp (cm) #

Zsp (cm) 3.9 #

fc (MHz) 2.5 # # # # #

Y (cm) # # # # #

PD

PRF (Hz) 4500

FLy (cm) # # # #

TX-Level (dB) 0

Focus (mm) 49

PRF (Hz)

(μsec)

0.43

A

aprt

≤1

A

>1

aprt

Acoustic Output Reporting Table – Track 3, FDA 510(k)

(Per transducer/mode that exceeds MI or TI value of 1.0)

Transducer model: P4-2 Operating mode: M-mode

Associated Acoustic Parameters

Maximum Value --- 1.5 1.6 --- 0.26 1.4 2.2

min of [W

.

deq (Zsp)

Dim. of A

Other information

Pr @ PII max (MPa) 3.3

d eq@ PII max (cm) 0.24 1.0

Focal Length FLx (cm) 14 # 14 7.1

I pa.3 @ MI max (W/cm2) 570

Operator Control

a This Index is not relevant to this operating mode.

b This transducer is not intended for transcranial or neonatal cephalic uses.

c This formulation for TIS is less than that for an alternate formulation in this mode.

# No data is provided for this operation condition since the maximum index value is not reported for the reason listed.

MI TIS TIB TIC

Index Label Scan Non-scan Non-scan

Pr.3 (MPa) 2.4

W

o

), I

3(Z1

TA.3(Z1

Z1 (cm) 2.5

Zbp

Zsp

fc

aprt

Y (cm) 1.3 # 1.3 1.3 1.3

PD

PRF (Hz) 1000

FLy (cm) 5.5 # 5.5 5.5

TX-Level (dB) 0 0 0 0 0

Focus (mm) 49 140 140 49 71

PRF (Hz)

(mW) 350 # 26 350

)] (mW) 15

(cm)

(cm) 3.9

(cm)

(MHz) 2.5 2.6 # 2.6 2.1 2.4

X (cm)

(μsec)

2.5

3.6

0.25

1.7 # 1.7 1.4 1.7

0.43

A

aprt

≤1

A

>1

aprt

SYSTEM REFERENCE 1 - 17

1 Acoustic Output Reference

Acoustic Output Reporting Table – Track 3, FDA 510(k)

(Per transducer/mode that exceeds MI or TI value of 1.0)

Transducer model: P4-2 Operating mode: Pulsed Doppler

Associated Acoustic Parameters

MI TIS TIB TIC

Index Label Scan Non-scan Non-scan

A

Maximum Value --- 1.1 --- --- 1.1 3.9 2.2

P

(MPa) 1.7

r.3

min of [W

Dim. of A

W

o

), I

.

3(Z1

TA.3(Z1

Z1 (cm) 2.7

Zbp

Zsp

deq (Zsp)

fc

aprt

Y (cm) # # 1.3 1.3 1.3

(mW) # # 160 160

)] (mW) 92

(cm)

(cm) 3.7

(cm)

(MHz) 2.1 # # 2.1 2.1 2.1

X (cm)

2.7

3.8

0.59

# # 2.0 2.0 2.0

aprt

≤1

Other information

PD

PRF (Hz) 1300

Pr @ PII max (MPa) 2.0

d eq@ PII max (cm) 0.59 0.59

Focal Length FLx (cm) # # 14 14

FLy (cm) # # 5.5 5.5

I pa.3 @ MI max (W/cm2) 200

(μsec)

1.8

Operator Control

TX-Level (dB) 0 0 0 0

Focus (mm) 27 140 140 140

PRF (Hz) 13800 13800 13800

aprt

>1

Acoustic Output Reporting Table – Track 3, FDA 510(k)

(Per transducer/mode that exceeds MI or TI value of 1.0)

Transducer model: P4-2 Operating mode: Color / Power

Associated Acoustic Parameters

Maximum Value --- 1.3 --- --- 1.3 4.5 2.6

min of [W

.

deq (Zsp)

Dim. of A

Other information

Pr @ PII max (MPa) 3.0

d eq@ PII max (cm) 0.55 0.55

Focal Length FLx (cm) # # 14 14

I pa.3 @ MI max (W/cm2) 390

Operator Control

a This Index is not relevant to this operating mode.

b This transducer is not intended for transcranial or neonatal cephalic uses.

c This formulation for TIS is less than that for an alternate formulation in this mode.

# No data is provided for this operation condition since the maximum index value is not reported for the reason listed.

MI TIS TIB TIC

Index Label Scan Non-scan Non-scan

Pr.3 (MPa) 1.9

W

o

), I

3(Z1

TA.3(Z1

Z1 (cm) 2.7

Zbp

Zsp

fc

aprt

Y (cm) # # 1.3 1.3 1.3

PD

PRF (Hz) 1300

FLy (cm) # # 5.5 5.5

TX-Level (dB) 0 0 0 0

Focus (mm) 71 140 140 140

PRF (Hz) 4000 4000 4000

(mW) # # 190 190

)] (mW) 110

(cm)

(cm) 5.6

(cm)

(MHz) 2.1 # # 2.1 2.1 2.1

X (cm)

(μsec)

2.7

3.8

0.55

# # 2.0 2.0 2.0

1.8

A

aprt

≤1

A

>1

aprt

1 - 18 SYSTEM REFERENCE

1 Acoustic Output Reference

Acoustic Output Reporting Table – Track 3, FDA 510(k)

(Per transducer/mode that exceeds MI or TI value of 1.0)

Transducer model: P4-2 Operating mode: CW Doppler

Associated Acoustic Parameters

Maximum Value --- 0.08 --- 0.49 # 2.6 1.1

min of [W

.

deq (Zsp)

Dim. of A

Other information

Pr @ PII max (MPa) 0.16

d eq@ PII max (cm) 0.26 0.26

Focal Length FLx (cm) # 4.1 # 5.9

I pa.3 @ MI max (W/cm2) 0.54

Operator Control

MI TIS TIB TIC

Index Label Scan Non-scan Non-scan

P

(MPa) 0.12

r.3

W

o

), I

3(Z1

TA.3(Z1

Z1 (cm) #

Zbp

Zsp

fc

aprt

Y (cm) # 1.3 # 1.3 1.3

PD

PRF (Hz) -

FLy (cm) # 5.5 # 5.5

TX-Level (dB) 0 0 0 0

Focus (mm) 59 41 59 59

PRF (Hz)

(mW) # 41 55 55

)] (mW) #

(cm)

(cm) 3.7

(cm)

(MHz) 2.2 # 2.5 # 2.2 2.2

X (cm)

(μsec)

#

3.7

0.27

# 0.71 # 0.93 0.93

-

A

aprt

≤1

A

>1

aprt

Acoustic Output Reporting Table – Track 3, FDA 510(k)

(Per transducer/mode that exceeds MI or TI value of 1.0)

Transducer model: P9-4 Operating mode: B-mode

Associated Acoustic Parameters

Maximum Value --- 1.5 (a) (a) (a) (a) (a)

min of [W.3(Z1), ITA.3(Z1)] (mW) #

deq (Zsp) (cm) #

Dim. of Aaprt X (cm) # # # # #

Other information

Pr @ PII max (MPa) 3.4

d eq@ PII max (cm) # #

Focal Length FLx (cm) # # # #

I pa.3 @ MI max (W/cm2) 800

Operator Control

a This Index is not relevant to this operating mode.

b This transducer is not intended for transcranial or neonatal cephalic uses.

c This formulation for TIS is less than that for an alternate formulation in this mode.

# No data is provided for this operation condition since the maximum index value is not reported for the reason listed.

MI TIS TIB TIC

Index Label Scan Non-scan Non-scan

Pr.3 (MPa) 3.4

Wo (mW) # # # #

Z1 (cm) #

Zbp (cm) #

Zsp (cm) 0.60 #

fc (MHz) 5.4 # # # # #

Y (cm) # # # # #

PD

PRF (Hz) 2900

FLy (cm) # # # #

TX-Level (dB) 0

Focus (mm) 11

PRF (Hz)

(μsec)

0.12

A

aprt

≤1

A

>1

aprt

SYSTEM REFERENCE 1 - 19

1 Acoustic Output Reference

Acoustic Output Reporting Table – Track 3, FDA 510(k)

(Per transducer/mode that exceeds MI or TI value of 1.0)

Transducer model: P9-4 Operating mode: M-mode

Associated Acoustic Parameters

Maximum Value --- 1.5 2.4 0.49 --- 0.63 1.6

min of [W

.

deq (Zsp)

Dim. of A

Other information

Pr @ PII max (MPa) 3.4

d eq@ PII max (cm) 0.28 1.1

Focal Length FLx (cm) 14 14 # 6.0

I pa.3 @ MI max (W/cm2) 800

Operator Control

MI TIS TIB TIC

Index Label Scan Non-scan Non-scan

Pr.3 (MPa) 3.4

W

o

), I

3(Z1

TA.3(Z1

Z1 (cm) #

Zbp

Zsp

fc

aprt

Y (cm) 0.80 0.80 # 0.80 0.80

PD

PRF (Hz) 1000

FLy (cm) 3.5 3.5 # 3.5

TX-Level (dB) 0 0 0 0 0

Focus (mm) 11 140 140 11 60

PRF (Hz)

(mW) 57 14 6.6 57

)] (mW) #

(cm)

(cm) 0.60

(cm)

(MHz) 5.4 5.4 5.4 # 5.6 5.1

X (cm)

(μsec)

#

0.56

1.3

0.77 0.77 # 0.36 0.77

0.12

A

aprt

≤1

A

>1

aprt

Acoustic Output Reporting Table – Track 3, FDA 510(k)

(Per transducer/mode that exceeds MI or TI value of 1.0)

Transducer model: P9-4 Operating mode: Pulsed Doppler

Associated Acoustic Parameters

MI TIS TIB TIC

Index Label Scan Non-scan Non-scan

A

Maximum Value --- 0.82 --- 1.5 --- 2.6 1.6

P

(MPa) 1.9

r.3

min of [W

Dim. of A

W

o

), I

.

3(Z1

TA.3(Z1

Z1 (cm) #

Zbp

Zsp

deq (Zsp)

fc

aprt

Y (cm) # 0.80 # 0.80 0.80

(mW) # 57 75 57

)] (mW) #

(cm)

(cm) 0.50

(cm)

(MHz) 5.3 # 5.3 # 3.7 5.3

X (cm)

#

4.1

0.25

# 0.77 # 0.77 0.77

aprt

≤1

Other information

PD

PRF (Hz) 1300

Pr @ PII max (MPa) 2.0

d eq@ PII max (cm) 0.25 0.29

Focal Length FLx (cm) # 10 # 6.0

FLy (cm) # 3.5 # 3.5

I pa.3 @ MI max (W/cm2) 180

(μsec)

1.4

Operator Control

TX-Level (dB) 0 0 0 0

Focus (mm) 9.0 100 60 60

a This Index is not relevant to this operating mode.

b This transducer is not intended for transcranial or neonatal cephalic uses.

c This formulation for TIS is less than that for an alternate formulation in this mode.

# No data is provided for this operation condition since the maximum index value is not reported for the reason listed.

PRF (Hz) 10400 12500 10400

aprt

>1

1 - 20 SYSTEM REFERENCE

Siemens Sonoline G60 S User manual

Table of Contents

About This Manual

Conventions

1 Acoustic Output Reference

Transducer Technical Data and Acoustic Output

Display Resolution and Measurement Accuracy

Default Displayed MI and TI Values by Transducer

Transducers and Intended Applications

IEC 61157 Acoustic Output Reporting

Track 3, FDA 510(k) Acoustic Output Reporting

Summary Table for Acoustic Output

Definitions