prosound -α 6 Instruction Manual Power Data Book rev 1

Page 2

ProSound logo is a registered trademark or trademark of Hitachi Aloka Medical, Ltd. in the Japan and/or other

countries.

Microsoft, Windows and Windows Media are either registered trademarks or trademarks of Microsoft Corporation in

the United States and/or other countries.

VS-FlexGrid Pro copyright©1999-2000 Videosoft Corporation.

Portions of this software are based in part on the work of the Independent JPEG Group.

All brand name, product name, and system name are registered trademarks or trademarks of their respective owners. In

this manual, ™ and ® are omitted.

Copyright©Hitachi Aloka Medical, Ltd. All rights reserved.

MN1-5860 rev.1

Page 3

Introduction

Introduction

This is an instruction manual for the model ProSound α6, a diagnostic ultrasound system.

Read the manual carefully before using the system. Take special note of the items in Chapter 1,

"Safety Precautions" of the Safety Instruction manual.

Maintain this manual for future reference.

Symbols Used in this Document

The following items are important in preventing harm or injury to equipment operator or patient.

There are four levels of harm/damage that can be caused by ignoring instructions or displays

and using the equipment incorrectly: "Danger", "Warning", "Caution", and "Note".

These types are indicated by the following symbols.

Indicates an imminently hazardous situation that will result in the death of or

serious injury to the equipment operator.

Indicates a hazardous situation that could result in death or serious injury.

Indicates a hazardous situation that may result in slight or moderate injury, or

property damage.

Indicates a request concerning an item that must be observed in order to

prevent damage or deterioration to the equipment and also to ensure effective

use.

Cautions use the following graphics.

This mark indicates and alert, additional information.

This mark indicates that the action is not allowed.

This mark indicates that the action is required.

Conventions used in this manual.

NOTE:

Notes containing additional information.

IMPORTANT:

Information that is considered especially important.

Input, output and screen-messages are presented in the following font: message.

Menus and switches are written as Menu. Submenus are indicated by the use of angle

brackets:Menu > sub-menu > sub-menu.

MN1-5860 rev.1

3

Page 4

Introduction

About the model “ProSound α6”

The ProSound α6 is intended to be used by doctors and other qualified personnel in fracture

diagnostics and hemodynamic diagnostics.

However, this equipment is not designed to be used in ophthalmic ultrasound diagnosis, as its

sound intensity is not compliant with ophthalmic restrictions established by the FDA.

Only physicians and other qualified personnel should operate this equipment for diagnostic

purposes. Read section 1-1 of the Safety Instruction.

1)

PRECAUTIONS Concerning the Use/Management of the ProSound α6

•

Do not disassemble, repair or remodel this equipment or optional features without our

consent.

NOTE:

Disassemble means to remove the parts or options from the equipment

using tools.

NOTE:

Remodel means to install or connect unauthorized parts or equipment,

including the power cord.

•

Assembly of the equipment or optional accessories shall be performed by a third party

certified by us. Please contact one of our offices listed on back cover.

NOTE:

Assemble means to install or connect parts or optional accessories on the

device using tools.

2)

•

Transporting this equipment (by vehicle/ship) shall be performed by a third party certified

by the manufacturer. Please contact one of our offices listed on back cover.

•

Please conduct routine cleaning and inspection of the equipment. Refer to Chapter 5 of the

Safety Instruction for details.

•

Ensure that the output level of the scan conforms to the required duration of diagnosis.

•

If any malfunction or abnormality is discovered during operation of the equipment, remove

the probe from the patient immediately and discontinue use. If any abnormality is observed

in the patient, provide proper care as quickly as possible. Refer to Chapter 4 of the Safety

Instructions for more information on dealing with the equipment appropriately. If the

malfunction is not listed in Chapter 4 of the Safety Instruction manual, contact one of our

offices listed on back cover.

PRECAUTIONS for the ProSound α6 Installation

This equipment is a electrical medical device that is intended for use in hospitals, and

research facilities. The device should be installed in accordance with the following

guidelines.

•

Install in accordance with Chapter 3 of the Safety Instructions.

•

Install in an environment that conforms to the operating environments indicated in section

2-2-2 of the Safety Instruction manual.

•

Install in an environment that ensures electromagnetic compatibility, in accordance with

section 1-2-6 of the Safety Instruction manual, "Precautions Concerning the Maintenance

of Electromagnetic Compatibility," and Item 1-3, "Guidelines for Electromagnetic

compatibility."

NOTE:

The electromagnetic compatibility (EMC) is the ability of device to function

satisfactorily in its electromagnetic environment without introducing intolerable

electromagnetic disturbance to anything in that environment.

4

MN1-5860 rev.1

Page 5

Introduction

Classification of model “ProSound α6”

• Protection against electric shock (ME equipment): class I • ME equipment

• Protection Against Electric Shock (Applied Parts): Type BF Applied Parts

–

Probe/scanner applied parts and parts treated as applied parts:

Refer to the following diagram (Probe/Scanner Pattern Diagram) and table.

Figure: Probe/Scanner Pattern Diagram

Above illustrates a surface/intraoperative probe. Below shows a coelomic probe.

B

C

A

connector

D

connector

C

A

Applicable part

of body

Applied part

parts treated as applied

parts

B - C length

surface of body

Ultrasonic irradiation area (D)

A to B

100 cm

Intraoperative

Ultrasonic irradiation area (D)

A to B

20 cm

Endocavity

A to C

A to C

-

–

ECG

The 2-meter length of the ECG cable extending from the ECG electrodes is treated as

applied part (see diagram below).

2 meters

ECG electrodes

connector

ECG patient lead

• Protection against electric shock (Defibrillation-proof applied parts): Not suitable

• Protection against harmful ingress of water or particulate matter

–

Equipment: IPX0 (Ordinary equipment)

–

Probe applied part: IPX7 (Watertight equipment)

• Suitability for use in an oxygen rich environment: Not suitable

• Method(s) of sterilization: Not suitable for sterilization/disinfection with medicinal

solution, gas or radiation.

• Mode of operation: Continuous operation

MN1-5860 rev.1

5

Page 6

CONTENTS

1 Acoustic Output Tables

1-1

Acoustic power measurement value ...................................................................................... 1-1

1-2

Display accuracy of MI/TI ....................................................................................................... 1-2

1-3

Acoustic Output Tables .......................................................................................................... 1-2

1-3-1

1-3-2

1-3-3

1-3-4

1-3-5

1-3-6

1-3-7

6

List of symbols for Acoustic Output Tables ............................................................................. 1-2

Convex Sector Probes ............................................................................................................ 1-4

Linear Probes ........................................................................................................................ 1-88

Phased ArraySector Probes ................................................................................................ 1-166

Biplane Probes .................................................................................................................... 1-196

3D Probes ........................................................................................................................... 1-208

Independent Probes ............................................................................................................ 1-220

MN1-5860 rev.1

Page 7

1 Acoustic Output Tables

1-1 Acoustic power measurement value

1

Acoustic Output Tables

1-1

Acoustic power measurement value

The acoustic measurements contained in this manual were made with this equipment ultrasound

system set to the maximum output in each mode. Measurements were obtained in water

following procedures outlined by the IEC, FDA, AIUM and NEMA.

The derated intensities provided are estimated from the following 3 factors.

• The intensity as measured water.

• The depth at which the intensity is obtained.

• The acoustic frequency of the probe.

Derated intensities are estimated from these factors using the following formula:

( -α s fawf s z  10 )

Iα  Iw s 10

Iα is the estimated intensity in tissue [mW/cm2]

Iw is the intensity measured in water at a distance [mW/cm2]

α is the acoustic attenuation coefficient[dB cm-1MHz-1]

fawfis the acoustic working frequency [MHz]

As this formula supposes acoustic attenuation coefficient (α) within tissues to be equal at 0.3[dB

cm-1MHz-1] and this value is lower than the acoustic attenuation of typical soft tissues, the

calculated exposure is generally higher than the actual exposure in the same position. However,

in the case of ultrasound beam transmitting through tissues filled with liquid, there may be cases

conversely that calculated exposure to be lower than the actual exposure at the same position,

because of transmitting with slight attenuation.

MN1-5860 rev.1

1-1

Page 8

1 Acoustic Output Tables

1-2 Display accuracy of MI/TI

1-2

Display accuracy of MI/TI

Mechanical index MI is related to the attenuated peak rarefactional acoustic pressure, pr,α. The

display accuracy of mechanical index should be related to the measurement uncertainties of pr.

Thermal index TI is related to the total power, P and the attenuated spatial-peak

temporal-average intensity Ispta,α both. The display accuracy of thermal indices should be

related to the measurement uncertainties of P and Ipi.

The display accuracies of MI and TI are provided on each acoustic output table.

1-3

Acoustic Output Tables

1-3-1

List of symbols for Acoustic Output Tables

Table: List of Symbols for Acoustic Output Table according IEC61157 4.2.2

1-2

Maximum Power

temporal-average power output (maximum power) (mW)

p-

peak-rarefactional acoustic pressure measured in water (MPa)

Iob

output beam intensity (mW/cm2)

Ispta

spatial-peak temporal-average intensity measured in water (mW/cm2)

lp

distance from the transducer output face to the point of maximum

pulse-pressure-squared integral (or maximum mean square acoustic pressure

for continuous wave systems) (mm)

ltt

transducer to transducer-output-face distance (mm)

lts

typical value for the transducer stand-off distance (mm)

wpb6 ( || )

-6 dB pulse beam-width at the point of maximum pulse-pressure-squared

integral for parallel direction (mm)

wpb6 ( ┴ )

-6 dB pulse beam-width at the point of maximum pulse-pressure-squared

integral for per-pendicular direction (mm)

prr (PRF)

pulse repetition rate (pulse repetition frequency) (Hz)

srr

scan repetition rate (Hz)

Output beam

dimensions

output beam dimensions (mm) X, Y

fawf

acoustic working frequency (MHz)

MN1-5860 rev.1

Page 9

1 Acoustic Output Tables

1-3 Acoustic Output Tables

Table: List of Symbols for Acoustic Output Table according IEC60601-2-37 (2007) Table

201.103

α

acoustic attenuation coefficient

Aaprt

- 12 dB output beam area

deq

equivalent aperture diameter

fawf

acoustic working frequency

Ipa, α

attenuated pulse-average intensity

Ipi

Ipi, α

pulse-intensity integral

attenuated pulse-intensity integral

MI

mechanical index

P

output power

Pα

attenuated output power

pr

peak-rarefactional acoustic pressure

pr, α

attenuated peak-rarefactional acoustic pressure

prr

pulse repetition rate

TI

thermal index

TIB

bone thermal index

TIC

cranial-bone thermal index

TIS

soft-tissue thermal index

td

X, Y

pluse duration

-12dB output beam dimensions

z

distance from the source to a specified point

zb

depth for TIB

zbp

break point depth

zs

depth for TIS

Acoustic output tables (Table 201.103) are provided for all probes with each mode regardless

of the value of TI and MI.

Following probes shall not exceed 1.0 of MI and TI throughout any operating condition;

• UST-533

• UST-987-7.5

• UST-995-7.5

• UST-MC11-8731

MN1-5860 rev.1

1-3

Page 10

1-4

pr

(mm)

(mm)

(%)

(ӆ) (mm)

(Hz)

(Hz)

(ц) (mm)

(ӆ) (mm)

(MHz)

(%)

19.05%

measurement uncertainty (%)

23.38%

P

36.03%

I pi

fawf

Acoustic Power-up fraction

Power-up mode

Acoustic Initialization fraction

Initialization mode

Acoustic output freeze

ltt

lts

Inclusive modes

prr(PRF)

srr(SRF)

Output beam dimensions

Mode

parameter

Maximum power

(mW)

p(MPa)

Iob

(mW/cm2)

2

Ispta

(mW/cm )

DVA%

(%)

Function

B/W Frequency Select

(MHz)

B/W Focus

B/W-Range

(cm)

B/W Line Density

B/W Scan Area

(%)

Doppler Image Select

Doppler Frequency Select

(MHz)

Doppler Focus

Doppler Velocity Range

(cm/sec)

Color Image Select

Color Doppler Frequency Select

(MHz)

Flow Focus

Color Velocity Range

(m/sec)

Color Line Density

Color Average

Flow Filter

Flow Scan Area

(%)

Triplex Velocity Range

lP

(mm)

wpb6

(ц) (mm)

BIspta

13

2.1

56

29

88

eF THE

4MHz

F3

12.0

HIGH

25

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

16

2.1

3.0

n/a

80

4.0

5.7

4.2

n/a

n/a

n/a

n/a

Yes

0.97

contact

Bp

13

2.6

36

29

85

eF THE

4MHz

F4

17.0

HIGH

25

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

19

1.7

2.2

n/a

60

6.2

5.7

4.3

n/a

n/a

n/a

n/a

Yes

0.97

contact

5.3

3.2

15

224

100

eF THE

5MHz

F4

3.0

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

22

1.6

2.0

1002

n/a

6.2

5.7

4.9

n/a

n/a

n/a

n/a

Yes

0.97

contact

(B+M)

Mp

Convex / Endorectal, Endovaginal

Acoustic power is controllable by the user.

UST-676P

10

3.2

30

441

99

eF EPHD

5MHz

F4

3.0

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

22

1.6

2.0

2003

n/a

6.2

5.7

4.9

n/a

n/a

n/a

n/a

Yes

0.97

contact

(B+M)

MIspta

9.4

1.7

29

342

100

Off

n/a

n/a

n/a

n/a

n/a

PENET

5.71MHz

F5

16.6

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

27

1.9

1.8

2480

n/a

5.7

5.7

5.7

n/a

n/a

n/a

n/a

Yes

0.97

contact

(Mflow)

Dp

12

1.6

45

445

97

Off

n/a

n/a

n/a

n/a

n/a

PENET

5MHz

F4

28.5

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

22

1.9

2.0

3720

n/a

4.8

5.7

5.0

n/a

n/a

n/a

n/a

Yes

0.97

contact

(Mflow)

DIspta

12

3.2

41

313

100

eF THE

5MHz

F4

17.0

HIGH

25

PENET

4MHz

F4

36.2

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

22

1.6

2.0

n/a

7.9

6.2

5.7

4.9

n/a

n/a

n/a

n/a

Yes

0.97

contact

(B+D)p

12

0.95

45

439

75

Off

6.67MHz

F1

17.0

HIGH

25

PENET

5MHz

F4

61.3

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

22

1.9

2.0

n/a

8.5

4.8

5.7

5.0

n/a

n/a

n/a

n/a

Yes

0.97

contact

(B+D)Ispta

12

3.2

41

44

100

THE

5MHz

F4

17.0

HIGH

25

n/a

n/a

n/a

n/a

PENET

4MHz

F4

0.33

MID

HIGH

#5

15

n/a

22

1.6

2.0

n/a

17

6.2

5.7

4.9

n/a

n/a

n/a

n/a

Yes

0.97

contact

13

1.2

50

54

78

Off

3.64MHz

F1

11.0

HIGH

25

n/a

n/a

n/a

n/a

PENET

4MHz

F4

0.10

MID

HIGH

#5

15

n/a

18

2.0

2.2

n/a

20

4.8

5.7

4.1

n/a

n/a

n/a

n/a

Yes

0.97

contact

12

3.2

44

387

100

eF THE

5MHz

F4

17.0

HIGH

25

PENET

5MHz

F4

28.5

PENET

3.64MHz

F4

0.06

MID

HIGH

#5

15

B_FIX

22

1.6

2.0

n/a

2.3

6.2

5.7

4.9

n/a

n/a

n/a

n/a

Yes

0.97

contact

12

0.89

46

434

75

Off

6.67MHz

F1

13.0

HIGH

25

PENET

5MHz

F4

72.4

PENET

4MHz

F2

0.06

MID

HIGH

#5

15

B_FIX

22

1.9

2.0

n/a

2.9

4.8

5.7

5.0

n/a

n/a

n/a

n/a

Yes

0.97

contact

(B+Bflow)p (B+Bflow)Ispta (B+Bflow+D)p (B+Bflow+D)Ispta

Acoustic output data in accordance with IEC 61157/4.2.2, accompanying literature

VER.1.1.0

1-3-2

Prosound 6

2012/11/6

1 Acoustic Output Tables

1-3 Acoustic Output Tables

Convex Sector Probes

MN1-5860 rev.1

Page 11

MN1-5860 rev.1

Index label

(mW)

d eq at max. I pi

TIC

B/W Line Density

n/a

Flow Scan Area

96

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

25

HIGH

17.0

F4

5MHz

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

25

HIGH

3.0

F2

5MHz

eF EPHD eF EPHD

85

B/W Focus

B/W Frequency Select

B/W Line Density

B/W-Range

Triplex Velocity Range

Flow Scan Area

Flow Filter

Color Average

Color Line Density

Color Velocity Range

Flow Focus

Color Doppler Frequency Select

Color Image Select

Doppler Velocity Range

Doppler Focus

Doppler Frequency Select

Doppler Image Select

conditions B/W Scan Area

control

Operating

Function

DVA%

FLy

Focal Length FLx

(%)

(m/sec)

(MHz)

(cm/sec)

(MHz)

(%)

(cm)

(MHz)

(%)

(cm)

(W/cm )

(cm)

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

25

HIGH

17.0

F4

4MHz

eF THE

85

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

25

HIGH

15.0

F8

5.71MHz

eF EPHD

81

2.8

6.9

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

-

-

-

-

-

-

-

-

-

-

-

-

-

-

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

A aprt<1cm A aprt>1cm

2

Non-scan

TIS

2

TIB

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Nonscan

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

25

HIGH

3.0

F2

4MHz

eF THE

99

2.4

0.50

0.57

1.0

4.1

13

0.36

TIC

23.38%

36.03%

19.05%

P

I pi

pr

TI

40% or 0.4, whichever larger

20% or 0.2, whichever larger

Display accuracy

pr

I pi

P

19.05%

36.03%

23.38%

measurement uncertainty (%)

TI

MI

40% or 0.4, whichever larger

20% or 0.2, whichever larger

Display accuracy

NOTE 5˴

MI

NOTE 5˴

NOTE 4˴If the requirements of 201.12.4.2b are met, it is not required to enter any data in the column related to MI.

measurement uncertainty (%)

NOTE 3˴If the requirements of 201.12.4.2a are met, it is not required to enter any data in the columns related to TIS, TIB or TIC.

NOTE 4˴If the requirements of 201.12.4.2b are met, it is not required to enter any data in the column related to MI.

NOTE 3˴If the requirements of 201.12.4.2a are met, it is not required to enter any data in the columns related to TIS, TIB or TIC.

NOTE 2㵘Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or

neonatal cephalic uses

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

-

-

-

-

-

-

-

2.6

0.50

2.6

190

0.57

1.8

5.7

9.9

0.27

Scan

NOTE 2㵘Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or

neonatal cephalic uses

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

-

-

-

-

-

-

-

-

-

2

3880

0.38

4.3

1.7

2.1

1.0

MI

B-mode

NOTE 1㵘Data should only be entered in one of the columns related to TIS

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

25

HIGH

3.0

F8

5.71MHz

eF THE

79

-

-

information I pa,α at max.MI

Operating Mode:

NOTE 1㵘Data should only be entered in one of the columns related to TIS

n/a

n/a

Flow Filter

Triplex Velocity Range

n/a

Color Average

(%)

n/a

n/a

Color Line Density

n/a

(m/sec)

n/a

Color Velocity Range

(MHz)

Flow Focus

Color Doppler Frequency Select

n/a

n/a

(cm/sec)

Doppler Velocity Range

Color Image Select

n/a

n/a

Doppler Focus

Doppler Frequency Select

25

HIGH

n/a

(MHz)

F4

17.0

Doppler Image Select

(%)

(cm)

(MHz)

4MHz

B/W Focus

B/W Frequency Select

B/W-Range

conditions B/W Scan Area

control

Operating

eF THE

89

2.8

(cm)

(%)

6.9

209

(W/cm )

(cm)

2

(μsec)

(Hz)

(cm)

(cm)

(cm)

Other

Y

X

(MHz)

(cm)

(cm)

(MPa)

0.57

Dim of A aprt

f awf

d eq(z b)

z at max. I pi,α

(cm)

(cm)

(cm)

(mW)

(mW)

(MPa)

d eq at max. I pi

(cm)

0.17

0.57

1.0

4.9

z bp

parameters z b

acoustic

Associated z s

P

Min of [P α(z s), I ta,α(z s)]

p r, α

Maximum Index Value

2.7

-

0.62

4.9

11

0.39

(MPa)

-

-

-

0.19

1.7

3.8

0.26

Index label

td

Function

DVA%

FLy

Focal Length FLx

information I pa,α at max.MI

Other

prr

p r at max. I pi

0.57

-

-

-

-

-

-

TIB

Nonscan

prr

p r at max. I pi

(cm)

Y

1.8

5.7

-

2

0.38

(cm)

X

Dim of A aprt

4.3

1.7

8.7

0.24

A aprt<1cm A aprt>1cm

2

Non-scan

TIS

3460

(MHz)

f awf

1.1

2.2

Scan

UST-676P

Table 201.103 – Acoustic output reporting table

(μsec)

(Hz)

(cm)

td

(cm)

(cm)

parameters z b

d eq(z b)

(cm)

z at max. I pi,α

(cm)

z bp

acoustic

Associated z s

(mW)

(MPa)

p r, α

P

Min of [P α(z s), I ta,α(z s)]

Maximum Index Value

MI

Table 201.103 – Acoustic output reporting table

Transducer Model:

B/M-mode

Prosound 6

Operating Mode:

Transducer Model:

UST-676P

Prosound 6

1 Acoustic Output Tables

1-3 Acoustic Output Tables

1-5

Page 12

1-6

Index label

(mW)

(MHz)

(cm)

(cm)

X

Y

f awf

Dim of A aprt

1.5

(cm)

d eq at max. I pi

B/W Line Density

n/a

Flow Scan Area

TIC

z bp

Other

Dim of A aprt

f awf

d eq(z b)

z at max. I pi,α

parameters z b

acoustic

Associated z s

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

99.6

F2

5MHz

PENET

n/a

n/a

n/a

n/a

n/a

Off

96

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

99.6

F2

5MHz

PENET

n/a

n/a

n/a

n/a

n/a

Off

96

B/W Focus

B/W Frequency Select

B/W Line Density

B/W-Range

Triplex Velocity Range

Flow Scan Area

Flow Filter

Color Average

Color Line Density

Color Velocity Range

Flow Focus

Color Doppler Frequency Select

Color Image Select

Doppler Velocity Range

Doppler Focus

Doppler Frequency Select

Doppler Image Select

conditions B/W Scan Area

control

Operating

Function

DVA%

FLy

Focal Length FLx

information I pa,α at max.MI

d eq at max. I pi

Y

X

P

Min of [P α(z s), I ta,α(z s)]

p r, α

Maximum Index Value

2

(%)

(m/sec)

(MHz)

(cm/sec)

(MHz)

(%)

(cm)

(MHz)

(%)

(cm)

(W/cm )

(cm)

(cm)

(MPa)

(μsec)

(Hz)

(cm)

(cm)

(MHz)

(cm)

(cm)

(cm)

(cm)

(cm)

(mW)

(mW)

(MPa)

1.2

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

3.0

F4

4MHz

eF THE

100

266

3.1

1000

0.38

4.3

1.7

2.5

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

-

-

-

-

-

-

-

-

-

-

-

-

Scan

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

3.0

F6

5MHz

eF EPHD

90

2.6

4.5

0.57

1.1

4.8

12

0.27

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

-

-

-

-

-

-

-

-

-

-

-

-

-

-

A aprt<1cm A aprt>1cm

2

Non-scan

TIS

2

TIB

99

2.6

2.1

0.57

0.62

4.9

10

0.39

TIC

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

3.0

F4

5MHz

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

3.0

F4

5MHz

eF EPHD eF EPHD

99

0.17

0.57

0.62

4.9

0.19

1.7

10

0.71

Nonscan

23.38%

36.03%

19.05%

P

I pi

pr

TI

40% or 0.4, whichever larger

20% or 0.2, whichever larger

Display accuracy

pr

I pi

P

19.05%

36.03%

23.38%

measurement uncertainty (%)

TI

MI

40% or 0.4, whichever larger

20% or 0.2, whichever larger

Display accuracy

NOTE 5˴

MI

NOTE 5˴

NOTE 4˴If the requirements of 201.12.4.2b are met, it is not required to enter any data in the column related to MI.

measurement uncertainty (%)

NOTE 3˴If the requirements of 201.12.4.2a are met, it is not required to enter any data in the columns related to TIS, TIB or TIC.

NOTE 4˴If the requirements of 201.12.4.2b are met, it is not required to enter any data in the column related to MI.

NOTE 3˴If the requirements of 201.12.4.2a are met, it is not required to enter any data in the columns related to TIS, TIB or TIC.

NOTE 2㵘Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or

neonatal cephalic uses

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

-

-

-

-

n/a

n/a

n/a

n/a

n/a

-

-

3.4

0.50

0.57

0.22

5.0

12

0.77

MI

M-mode

NOTE 2㵘Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or

neonatal cephalic uses

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

99.6

F2

5MHz

PENET

n/a

n/a

n/a

n/a

n/a

Off

96

-

-

0.27

0.57

0.22

5.0

0.25

0.23

12

1.0

Index label

Operating Mode:

NOTE 1㵘Data should only be entered in one of the columns related to TIS

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

-

-

-

-

n/a

n/a

n/a

n/a

n/a

-

-

3.4

0.50

TIB

Nonscan

UST-676P

Table 201.103 – Acoustic output reporting table

NOTE 1㵘Data should only be entered in one of the columns related to TIS

n/a

n/a

Flow Filter

Triplex Velocity Range

n/a

Color Average

(%)

n/a

n/a

Color Line Density

n/a

(m/sec)

n/a

Color Velocity Range

(MHz)

Flow Focus

Color Doppler Frequency Select

n/a

36.2

(cm/sec)

Doppler Velocity Range

Color Image Select

F4

Doppler Focus

4MHz

Doppler Frequency Select

(MHz)

PENET

n/a

n/a

n/a

n/a

Doppler Image Select

(%)

(cm)

(MHz)

n/a

B/W Focus

B/W Frequency Select

B/W-Range

conditions B/W Scan Area

control

Operating

Off

100

-

(cm)

(%)

-

(W/cm )

(cm)

Function

DVA%

FLy

Focal Length FLx

66

3790

(MPa)

prr

p r at max. I pi

2

-

-

-

-

-

-

-

2

prr

p r at max. I pi

0.57

0.22

5.0

12

0.29

A aprt<1cm A aprt>1cm

2

Non-scan

TIS

td

-

-

-

-

-

Scan

0.94

4.1

1.6

1.2

0.60

(μsec)

(Hz)

information I pa,α at max.MI

Other

(cm)

td

(cm)

(cm)

parameters z b

d eq(z b)

(cm)

z at max. I pi,α

(cm)

z bp

acoustic

Associated z s

(mW)

(MPa)

p r, α

P

Min of [P α(z s), I ta,α(z s)]

Maximum Index Value

MI

Table 201.103 – Acoustic output reporting table

Transducer Model:

PWD-mode

Prosound 6

Operating Mode:

Transducer Model:

UST-676P

Prosound 6

1 Acoustic Output Tables

1-3 Acoustic Output Tables

MN1-5860 rev.1

Page 13

MN1-5860 rev.1

Index label

(mW)

(MHz)

(cm)

(cm)

X

Y

f awf

Dim of A aprt

3.1

(cm)

B/W Line Density

n/a

Flow Scan Area

TIC

z bp

Other

Dim of A aprt

f awf

d eq(z b)

z at max. I pi,α

parameters z b

acoustic

Associated z s

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

123

F4

4MHz

PENET

25

HIGH

9.0

F1

8MHz

Off

83

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

66.4

F2

5MHz

PENET

25

HIGH

13.0

F2

4MHz

eF THE

100

B/W Focus

B/W Frequency Select

B/W Line Density

B/W-Range

Triplex Velocity Range

Flow Scan Area

Flow Filter

Color Average

Color Line Density

Color Velocity Range

Flow Focus

Color Doppler Frequency Select

Color Image Select

Doppler Velocity Range

Doppler Focus

Doppler Frequency Select

Doppler Image Select

conditions B/W Scan Area

control

Operating

Function

DVA%

FLy

Focal Length FLx

information I pa,α at max.MI

d eq at max. I pi

Y

X

P

Min of [P α(z s), I ta,α(z s)]

p r, α

Maximum Index Value

2

(%)

(m/sec)

(MHz)

(cm/sec)

(MHz)

(%)

(cm)

(MHz)

(%)

(cm)

(W/cm )

(cm)

(cm)

(MPa)

(μsec)

(Hz)

(cm)

(cm)

(MHz)

(cm)

(cm)

(cm)

(cm)

(cm)

(mW)

(mW)

(MPa)

n/a

n/a

n/a

n/a

n/a

0.50

F4

4MHz

PENET

n/a

n/a

n/a

n/a

n/a

n/a

13.0

n/a

n/a

eF EPHD

100

66

1.5

5210

0.71

4.1

1.6

1.2

0.60

n/a

n/a

n/a

n/a

n/a

-

-

-

-

n/a

n/a

n/a

n/a

n/a

n/a

-

n/a

n/a

-

-

-

-

-

-

-

-

-

Scan

n/a

n/a

n/a

n/a

n/a

0.57

F2

5MHz

PENET

n/a

n/a

n/a

n/a

n/a

n/a

13.0

n/a

n/a

Off

99

3.4

0.50

0.57

0.22

5.0

12

0.29

n/a

n/a

n/a

n/a

n/a

-

-

-

-

n/a

n/a

n/a

n/a

n/a

n/a

-

n/a

n/a

-

-

-

-

-

-

-

-

-

-

-

A aprt<1cm A aprt>1cm

2

Non-scan

TIS

2

TIB

n/a

n/a

n/a

n/a

n/a

0.76

F2

5MHz

PENET

n/a

n/a

n/a

n/a

n/a

n/a

13.0

n/a

n/a

Off

96

0.27

0.57

0.22

5.0

0.25

0.23

12

1.0

Nonscan

n/a

n/a

n/a

n/a

n/a

0.57

F2

5MHz

PENET

n/a

n/a

n/a

n/a

n/a

n/a

13.0

n/a

n/a

Off

99

3.4

0.50

0.57

0.22

5.0

12

0.77

TIC

23.38%

36.03%

19.05%

P

I pi

pr

TI

40% or 0.4, whichever larger

20% or 0.2, whichever larger

Display accuracy

pr

I pi

P

19.05%

36.03%

23.38%

measurement uncertainty (%)

TI

MI

40% or 0.4, whichever larger

20% or 0.2, whichever larger

Display accuracy

NOTE 5˴

MI

NOTE 5˴

NOTE 4˴If the requirements of 201.12.4.2b are met, it is not required to enter any data in the column related to MI.

measurement uncertainty (%)

NOTE 3˴If the requirements of 201.12.4.2a are met, it is not required to enter any data in the columns related to TIS, TIB or TIC.

NOTE 4˴If the requirements of 201.12.4.2b are met, it is not required to enter any data in the column related to MI.

NOTE 3˴If the requirements of 201.12.4.2a are met, it is not required to enter any data in the columns related to TIS, TIB or TIC.

NOTE 2㵘Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or

neonatal cephalic uses

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

-

-

-

-

-

-

-

-

-

-

-

3.4

0.50

0.57

0.22

4.1, 5.0

12

0.72

MI

Mflow-mode

NOTE 2㵘Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or

neonatal cephalic uses

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

123

F3

5MHz

PENET

25

HIGH

17.0

F1

6.67MHz

Off

88

-

-

0.20

0.57

0.48

4.1

0.20

1.4

12

0.93

Index label

Operating Mode:

NOTE 1㵘Data should only be entered in one of the columns related to TIS

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

-

-

-

-

-

-

-

-

-

-

-

3.4

1.1

TIB

Nonscan

UST-676P

Table 201.103 – Acoustic output reporting table

NOTE 1㵘Data should only be entered in one of the columns related to TIS

n/a

n/a

Flow Filter

Triplex Velocity Range

n/a

(%)

n/a

Color Average

n/a

Color Line Density

n/a

(m/sec)

n/a

Color Velocity Range

(MHz)

Flow Focus

Color Doppler Frequency Select

n/a

36.2

(cm/sec)

Doppler Velocity Range

Color Image Select

F4

Doppler Focus

4MHz

Doppler Frequency Select

(MHz)

PENET

25

Doppler Image Select

(%)

HIGH

17.0

F4

4MHz

(cm)

(MHz)

B/W Frequency Select

B/W-Range

B/W Focus

eF THE

100

-

(cm)

(%)

-

(W/cm )

(cm)

Function

DVA%

FLy

Focal Length FLx

266

3540

(MPa)

d eq at max. I pi

2

-

-

-

-

-

-

-

2

prr

p r at max. I pi

0.57

0.35

5.0

12

0.29

A aprt<1cm A aprt>1cm

2

Non-scan

TIS

td

-

-

-

-

-

Scan

0.38

4.3

1.7

prr

p r at max. I pi

conditions B/W Scan Area

control

Operating

1.2

2.5

(μsec)

(Hz)

information I pa,α at max.MI

Other

(cm)

td

(cm)

(cm)

parameters z b

d eq(z b)

(cm)

z at max. I pi,α

(cm)

z bp

acoustic

Associated z s

(mW)

(MPa)

p r, α

P

Min of [P α(z s), I ta,α(z s)]

Maximum Index Value

MI

Table 201.103 – Acoustic output reporting table

Transducer Model:

B/PWD-mode

Prosound 6

Operating Mode:

Transducer Model:

UST-676P

Prosound 6

1 Acoustic Output Tables

1-3 Acoustic Output Tables

1-7

Page 14

1-8

Index label

(mW)

(MHz)

(cm)

(cm)

X

Y

f awf

Dim of A aprt

3.1

(cm)

B/W Line Density

B/W-Range

B/W Focus

TIC

n/a

-

-

-

-

-

-

-

-

n/a

n/a

n/a

n/a

-

-

-

-

-

-

-

n/a

15

#5

HIGH

MID

0.12

F2

4MHz

PENET

n/a

n/a

n/a

n/a

25

HIGH

3.0

F1

4MHz

eF THE

100

3.0

0.50

0.57

0.69

4.1, 4.2

z bp

Other

Dim of A aprt

f awf

d eq(z b)

z at max. I pi,α

parameters z b

acoustic

Associated z s

B/W Focus

B/W Line Density

B/W-Range

Triplex Velocity Range

Flow Scan Area

Flow Filter

Color Average

Color Line Density

Color Velocity Range

Flow Focus

Color Doppler Frequency Select

Color Image Select

Doppler Velocity Range

Doppler Focus

Doppler Frequency Select

Doppler Image Select

conditions B/W Scan Area

control

Operating

B/W Frequency Select

Function

DVA%

FLy

Focal Length FLx

information I pa,α at max.MI

d eq at max. I pi

Y

X

P

Min of [P α(z s), I ta,α(z s)]

p r, α

Maximum Index Value

2

(%)

(m/sec)

(MHz)

(cm/sec)

(MHz)

(%)

(cm)

(MHz)

(%)

(cm)

(W/cm )

(cm)

(cm)

(MPa)

(μsec)

(Hz)

(cm)

(cm)

(MHz)

(cm)

(cm)

(cm)

(cm)

(cm)

(mW)

(mW)

(MPa)

1.2

n/a

15

#5

HIGH

MID

0.69

F2

4MHz

PENET

n/a

n/a

n/a

n/a

25

HIGH

11.0

F4

4MHz

THE

100

266

3.1

6940

0.38

4.3

1.7

2.5

n/a

15

#5

HIGH

MID

0.12

F3

5MHz

PENET

n/a

n/a

n/a

n/a

25

HIGH

11.0

F1

5.71MHz

THE

85

3.4

1.1

0.57

0.82

5.0, 5.5

13

0.30

Scan

n/a

-

-

-

-

-

-

-

-

n/a

n/a

n/a

n/a

-

-

-

-

-

-

-

-

-

-

-

-

-

-

n/a

-

-

-

-

-

-

-

-

n/a

n/a

n/a

n/a

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

A aprt<1cm A aprt>1cm

2

Non-scan

TIS

2

TIB

n/a

-

-

-

-

-

-

-

-

n/a

n/a

n/a

n/a

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Nonscan

n/a

15

#5

HIGH

MID

0.12

F2

4MHz

PENET

n/a

n/a

n/a

n/a

25

HIGH

3.0

F1

4MHz

eF THE

100

3.0

0.50

0.57

0.69

4.1, 4.2

13

0.46

TIC

23.38%

36.03%

19.05%

P

I pi

pr

TI

40% or 0.4, whichever larger

20% or 0.2, whichever larger

Display accuracy

pr

I pi

P

19.05%

36.03%

23.38%

measurement uncertainty (%)

TI

MI

40% or 0.4, whichever larger

20% or 0.2, whichever larger

Display accuracy

NOTE 5˴

MI

NOTE 5˴

NOTE 4˴If the requirements of 201.12.4.2b are met, it is not required to enter any data in the column related to MI.

measurement uncertainty (%)

NOTE 3˴If the requirements of 201.12.4.2a are met, it is not required to enter any data in the columns related to TIS, TIB or TIC.

NOTE 4˴If the requirements of 201.12.4.2b are met, it is not required to enter any data in the column related to MI.

NOTE 3˴If the requirements of 201.12.4.2a are met, it is not required to enter any data in the columns related to TIS, TIB or TIC.

NOTE 2㵘Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or

neonatal cephalic uses

n/a

-

-

-

-

-

-

-

-

n/a

n/a

n/a

n/a

-

-

-

-

-

-

-

-

-

-

-

-

-

13

0.46

MI

B/Bflow-mode

NOTE 1㵘Data should only be entered in one of the columns related to TIS

n/a

-

-

-

-

-

-

-

-

n/a

n/a

n/a

n/a

-

-

-

-

-

-

-

-

-

-

Index label

Operating Mode:

NOTE 2㵘Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or

neonatal cephalic uses

n/a

15

#5

HIGH

MID

0.12

F3

5MHz

PENET

n/a

n/a

n/a

n/a

25

HIGH

11.0

F1

5.71MHz

THE

85

-

-

TIB

Nonscan

UST-676P

Table 201.103 – Acoustic output reporting table

NOTE 1㵘Data should only be entered in one of the columns related to TIS

n/a

15

(%)

#5

Triplex Velocity Range

Flow Scan Area

Color Average

Flow Filter

MID

HIGH

Color Line Density

F2

0.69

(m/sec)

4MHz

Color Velocity Range

(MHz)

Flow Focus

Color Doppler Frequency Select

PENET

n/a

(cm/sec)

Doppler Velocity Range

Color Image Select

n/a

n/a

Doppler Focus

Doppler Frequency Select

25

HIGH

n/a

(MHz)

F4

11.0

Doppler Image Select

(%)

(cm)

THE

4MHz

(MHz)

B/W Frequency Select

100

3.4

(cm)

(%)

1.1

(W/cm )

(cm)

Function

DVA%

FLy

Focal Length FLx

266

6940

(MPa)

d eq at max. I pi

2

-

-

-

-

-

-

-

2

prr

p r at max. I pi

-

-

-

-

-

A aprt<1cm A aprt>1cm

2

Non-scan

TIS

td

0.57

0.82

5.0, 5.5

13

0.30

Scan

0.38

4.3

1.7

prr

p r at max. I pi

conditions B/W Scan Area

control

Operating

1.2

2.5

(μsec)

(Hz)

information I pa,α at max.MI

Other

(cm)

td

(cm)

(cm)

parameters z b

d eq(z b)

(cm)

z at max. I pi,α

(cm)

z bp

acoustic

Associated z s

(mW)

(MPa)

p r, α

P

Min of [P α(z s), I ta,α(z s)]

Maximum Index Value

MI

Table 201.103 – Acoustic output reporting table

Transducer Model:

Power flow-mode

Prosound 6

Operating Mode:

Transducer Model:

UST-676P

Prosound 6

1 Acoustic Output Tables

1-3 Acoustic Output Tables

MN1-5860 rev.1

Page 15

MN1-5860 rev.1

Index label

UST-676P

(mW)

(MHz)

(cm)

(cm)

X

Y

f awf

Dim of A aprt

3.1

B/W Line Density

B/W-Range

B/W Focus

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

B_FIX

15

#5

HIGH

MID

0.06

F5

5MHz

PENET

44.3

F2

5MHz

PENET

25

HIGH

5.0

F1

5.71MHz

eF THE

100

3.4

0.50

0.57

0.22

5.0

7.8

0.19

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

A aprt<1cm A aprt>1cm

2

Non-scan

TIS

2

B_FIX

15

#5

HIGH

MID

0.06

F1

4MHz

PENET

123

F4

4MHz

PENET

25

HIGH

9.0

F1

8MHz

Off

83

0.20

0.57

0.48

4.1

0.20

1.4

12

0.93

Nonscan

TIB

B/Bflow/D-mode

B_FIX

15

#5

HIGH

MID

0.06

F1

5MHz

PENET

66.4

F2

5MHz

PENET

25

HIGH

7.0

F1

4MHz

eF THE

100

3.4

0.50

0.57

0.22

5.0

12

0.74

TIC

NOTE 5˴

23.38%

36.03%

19.05%

P

I pi

pr

measurement uncertainty (%)

TI

MI

40% or 0.4, whichever larger

20% or 0.2, whichever larger

Display accuracy

NOTE 4˴If the requirements of 201.12.4.2b are met, it is not required to enter any data in the column related to MI.

NOTE 3˴If the requirements of 201.12.4.2a are met, it is not required to enter any data in the columns related to TIS, TIB or TIC.

NOTE 2㵘Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or

neonatal cephalic uses

NOTE 1㵘Data should only be entered in one of the columns related to TIS

B_FIX

15

(%)

#5

Triplex Velocity Range

Flow Scan Area

Color Average

Flow Filter

MID

HIGH

Color Line Density

0.06

(m/sec)

Color Velocity Range

4MHz

F2

(MHz)

Flow Focus

Color Doppler Frequency Select

PENET

44.3

(cm/sec)

Doppler Velocity Range

Color Image Select

F4

4MHz

Doppler Focus

Doppler Frequency Select

25

HIGH

PENET

(MHz)

F4

17.0

Doppler Image Select

(%)

(cm)

4MHz

conditions B/W Scan Area

control

Operating

eF THE

(MHz)

B/W Frequency Select

100

-

(cm)

(%)

-

-

-

-

-

-

Scan

(W/cm )

(cm)

Function

DVA%

FLy

Focal Length FLx

266

(cm)

d eq at max. I pi

2

4470

(MPa)

prr

p r at max. I pi

0.38

4.3

1.2

2.5

1.2

MI

(μsec)

(Hz)

information I pa,α at max.MI

Other

(cm)

td

(cm)

(cm)

parameters z b

d eq(z b)

(cm)

z at max. I pi,α

(cm)

z bp

(mW)

(MPa)

p r, α

Associated z s

acoustic

Operating Mode:

Table 201.103 – Acoustic output reporting table

P

Min of [P α(z s), I ta,α(z s)]

Maximum Index Value

Transducer Model:

Prosound 6

1 Acoustic Output Tables

1-3 Acoustic Output Tables

1-9

Page 16

1-10

pr

19.05%

measurement uncertainty (%)

23.38%

P

36.03%

I pi

Mode

Bp

parameter

Maximum power

(mW)

7.3

p(MPa)

1.5

Iob

12

(mW/cm2)

2

Ispta

17

(mW/cm )

DVA%

(%)

100

Function

B/W Frequency Select

(MHz) 5.71MHz

B/W Focus

F6

B/W-Range

(cm)

4.0

B/W Line Density

HIGH

B/W Scan Area

(%)

25

Doppler Image Select

n/a

Doppler Frequency Select

(MHz)

n/a

Doppler Focus

n/a

Doppler Velocity Range

(cm/sec)

n/a

Color Image Select

n/a

Color Doppler Frequency Select

(MHz)

n/a

Flow Focus

n/a

Color Velocity Range

(m/sec)

n/a

Color Line Density

n/a

Color Average

n/a

Flow Filter

n/a

Flow Scan Area

(%)

n/a

Triplex Velocity Range

n/a

lP

(mm)

33

wpb6

(ц) (mm)

1.9

(ӆ) (mm)

1.7

prr(PRF)

(Hz)

n/a

srr(SRF)

(Hz)

89

Output beam dimensions

(ц) (mm)

7.7

(ӆ) (mm)

8.0

fawf

(MHz)

4.9

Acoustic Power-up fraction

(%)

n/a

Power-up mode

n/a

Acoustic Initialization fraction

(%)

n/a

Initialization mode

n/a

Acoustic output freeze

Yes

ltt

(mm)

1.0

lts

(mm) contact

Inclusive modes

Mp

0.99

1.5

1.6

38

100

5.71MHz

F6

4.0

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

33

1.9

1.7

1000

n/a

7.7

8.0

4.9

n/a

n/a

n/a

n/a

Yes

1.0

contact

(B+M)

BIspta

7.8

1.5

13

18

100

5MHz

F6

4.0

HIGH

25

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

33

1.9

1.8

n/a

89

7.7

8.0

4.8

n/a

n/a

n/a

n/a

Yes

1.0

contact

1.1

1.5

1.7

39

100

5MHz

F6

4.0

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

33

1.9

1.8

1002

n/a

7.7

8.0

4.8

n/a

n/a

n/a

n/a

Yes

1.0

contact

(B+M)

MIspta

DIspta

18

20

1.8

1.8

30

33

717

792

100

98

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

PENET

PENET

5MHz

5MHz

F6

F6

24.9

28.5

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

34

34

1.9

1.9

1.8

1.8

3255

3720

n/a

n/a

7.7

7.7

8.0

8.0

4.9

4.9

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

Yes

Yes

1.0

1.0

contact

contact

(Mflow)

(Mflow)

(B+D)

(B+D)

(B+Bflow+D) (B+Bflow+D)

Dp

22

1.5

44

87

100

5.71MHz

F6

14.0

HIGH

25

n/a

n/a

n/a

n/a

PENET

3.64MHz

F5

0.36

MID

HIGH

#5

15

n/a

33

1.9

1.7

n/a

9.9

7.7

8.0

4.9

n/a

n/a

n/a

n/a

Yes

1.0

contact

22

1.4

45

88

99

6.67MHz

F1

4.0

HIGH

25

n/a

n/a

n/a

n/a

PENET

3.64MHz

F5

0.72

MID

HIGH

#5

15

n/a

25

2.3

2.2

n/a

10

6.3

8.0

3.8

n/a

n/a

n/a

n/a

Yes

1.0

contact

(B+Bflow)p (B+Bflow)Ispta

Convex / Endovaginal Gynecological䋬Fetal

UST-984-5

Acoustic power is controllable by the user.

Acoustic output data in accordance with IEC 61157/4.2.2, accompanying literature

VER.1.1.0

Prosound 6

2012/11/6

1 Acoustic Output Tables

1-3 Acoustic Output Tables

MN1-5860 rev.1

Page 17

MN1-5860 rev.1

Index label

(mW)

d eq at max. I pi

B/W Focus

B/W Line Density

B/W-Range

TIC

F5

4.0

n/a

Flow Scan Area

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

25

HIGH

4.0

F8

5MHz

-

100

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

25

HIGH

4.0

F8

5MHz

-

100

B/W Focus

B/W Line Density

B/W-Range

Triplex Velocity Range

Flow Scan Area

Flow Filter

Color Average

Color Line Density

Color Velocity Range

Flow Focus

Color Doppler Frequency Select

Color Image Select

Doppler Velocity Range

Doppler Focus

Doppler Frequency Select

Doppler Image Select

conditions B/W Scan Area

control

Operating

B/W Frequency Select

Function

DVA%

FLy

Focal Length FLx

(%)

(m/sec)

(MHz)

(cm/sec)

(MHz)

(%)

(cm)

(MHz)

(%)

(cm)

(W/cm )

(cm)

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

25

HIGH

4.0

F5

5MHz

-

100

80

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

25

HIGH

4.0

F8

5MHz

-

100

2.9

5.3

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

-

-

-

-

-

-

-

-

-

-

-

-

-

-

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

A aprt<1cm A aprt>1cm

2

Non-scan

TIS

2

TIB

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Nonscan

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

25

HIGH

4.0

F8

5MHz

-

100

2.9

5.3

0.80

2.0

4.6

11

0.19

TIC

36.03%

19.05%

pr

23.38%

I pi

P

TI

40% or 0.4, whichever larger

20% or 0.2, whichever larger

Display accuracy

pr

I pi

P

19.05%

36.03%

23.38%

measurement uncertainty (%)

TI

MI

40% or 0.4, whichever larger

20% or 0.2, whichever larger

Display accuracy

NOTE 5˴

MI

NOTE 5˴

NOTE 4˴If the requirements of 201.12.4.2b are met, it is not required to enter any data in the column related to MI.

measurement uncertainty (%)

NOTE 3˴If the requirements of 201.12.4.2a are met, it is not required to enter any data in the columns related to TIS, TIB or TIC.

NOTE 4˴If the requirements of 201.12.4.2b are met, it is not required to enter any data in the column related to MI.

NOTE 3˴If the requirements of 201.12.4.2a are met, it is not required to enter any data in the columns related to TIS, TIB or TIC.

NOTE 2㵘Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or

neonatal cephalic uses

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

-

-

-

-

-

-

-

2.9

5.3

1.4

0.80

2.0

4.6

9.4

0.20

Scan

NOTE 2㵘Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or

neonatal cephalic uses

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

-

-

-

-

-

-

-

-

-

2

7440

0.16

4.8

2.5

0.99

0.45

MI

B-mode

NOTE 1㵘Data should only be entered in one of the columns related to TIS

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

25

HIGH

4.0

F8

5MHz

-

100

-

-

information I pa,α at max.MI

Operating Mode:

NOTE 1㵘Data should only be entered in one of the columns related to TIS

n/a

n/a

Flow Filter

Triplex Velocity Range

n/a

Color Average

(%)

n/a

n/a

Color Line Density

n/a

(m/sec)

n/a

Color Velocity Range

(MHz)

Flow Focus

Color Doppler Frequency Select

n/a

n/a

(cm/sec)

Doppler Velocity Range

Color Image Select

n/a

Doppler Focus

n/a

25

HIGH

Doppler Frequency Select

(MHz)

5MHz

n/a

(%)

(cm)

(MHz)

100

2.9

(cm)

(%)

5.3

80

(W/cm )

(cm)

2

(μsec)

(Hz)

(cm)

(cm)

(cm)

Other

Y

X

(MHz)

(cm)

(cm)

(MPa)

0.80

Dim of A aprt

f awf

d eq(z b)

z at max. I pi,α

(cm)

(cm)

(cm)

(mW)

(mW)

(MPa)

d eq at max. I pi

(cm)

0.26

0.80

2.0

4.6

z bp

parameters z b

acoustic

Associated z s

P

Min of [P α(z s), I ta,α(z s)]

p r, α

Maximum Index Value

1.4

-

1.2

4.6

7.5

0.14

(MPa)

-

-

-

0.40

2.3

0.73

0.020

Index label

td

Doppler Image Select

conditions B/W Scan Area

control

Operating

B/W Frequency Select

Function

DVA%

FLy

Focal Length FLx

information I pa,α at max.MI

Other

prr

p r at max. I pi

0.80

-

-

-

-

-

-

TIB

Nonscan

prr

p r at max. I pi

(cm)

Y

2.0

4.6

-

2

0.16

(cm)

X

Dim of A aprt

4.8

2.5

5.9

0.13

A aprt<1cm A aprt>1cm

2

Non-scan

TIS

5180

(MHz)

f awf

0.45

0.99

Scan

UST-984-5

Table 201.103 – Acoustic output reporting table

(μsec)

(Hz)

(cm)

td

(cm)

(cm)

parameters z b

d eq(z b)

(cm)

z at max. I pi,α

(cm)

z bp

acoustic

Associated z s

(mW)

(MPa)

p r, α

P

Min of [P α(z s), I ta,α(z s)]

Maximum Index Value

MI

Table 201.103 – Acoustic output reporting table

Transducer Model:

B/M-mode

Prosound 6

Operating Mode:

Transducer Model:

UST-984-5

Prosound 6

1 Acoustic Output Tables

1-3 Acoustic Output Tables

1-11

Page 18

1-12

Index label

(mW)

d eq at max. I pi

TIC

B/W Focus

B/W Line Density

B/W-Range

n/a

Flow Scan Area

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

66.4

F1

5MHz

PENET

n/a

n/a

n/a

n/a

n/a

-

100

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

66.4

F1

5MHz

PENET

n/a

n/a

n/a

n/a

n/a

-

100

B/W Focus

B/W Line Density

B/W-Range

Triplex Velocity Range

Flow Scan Area

Flow Filter

Color Average

Color Line Density

Color Velocity Range

Flow Focus

Color Doppler Frequency Select

Color Image Select

Doppler Velocity Range

Doppler Focus

Doppler Frequency Select

Doppler Image Select

conditions B/W Scan Area

control

Operating

B/W Frequency Select

Function

DVA%

FLy

(%)

(m/sec)

(MHz)

(cm/sec)

(MHz)

(%)

(cm)

(MHz)

(%)

(cm)

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

4.0

F5

5MHz

-

100

80

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

-

-

-

-

-

-

-

-

-

-

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

4.0

F8

5MHz

-

100

2.9

5.3

0.80

1.2

4.6

1.5

0.032

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

-

-

-

-

-

-

-

-

-

-

-

-

-

-

A aprt<1cm A aprt>1cm

2

Non-scan

TIS

2

TIB

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

4.0

F6

5MHz

-

100

0.19

0.80

0.77

4.8

0.21

2.6

1.1

0.049

Nonscan

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

n/a

4.0

F8

5MHz

-

100

2.9

5.3

0.80

1.2

4.6

1.5

0.033

TIC

23.38%

36.03%

19.05%

P

I pi

pr

TI

40% or 0.4, whichever larger

20% or 0.2, whichever larger

Display accuracy

pr

I pi

P

19.05%

36.03%

23.38%

measurement uncertainty (%)

TI

MI

40% or 0.4, whichever larger