prosound -α 6 Instruction Manual Power Data Book rev 1 PDF download

DIAGNOSTIC ULTRASOUND SYSTEM

Instruction Manual Power Data Book (volume 1/2)

Instruction manuals consist of Safety Instruction, this manual, How to Use and Measurement. Before using this system, please read Safety Instruction.

MN1-5860 rev.1

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

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

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

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

-

–

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

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

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

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

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

pulse-intensity integral

Ipi, α

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

pluse duration

X, Y

-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

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

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

25

HIGH

17.0

F4

5MHz

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

25

HIGH

17.0

F4

4MHz

eF THE

85

n/a

25

HIGH

15.0

F8

5.71MHz

eF EPHD

81

2.8

6.9

n/a

-

n/a

-

A aprt<1cm A aprt>1cm

2

Non-scan

TIS 2

TIB

n/a

-

Nonscan

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

-

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

-

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

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

Flow Filter

Triplex Velocity Range

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

(cm/sec)

Doppler Velocity Range

Color Image Select

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)

Other

Y

X

(MHz)

(cm)

(MPa)

0.57

Dim of A aprt

f awf

d eq(z b)

z at max. I pi,α

(cm)

(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)

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

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

99.6

F2

5MHz

PENET

n/a

Off

96

n/a

99.6

F2

5MHz

PENET

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)

(MHz)

(cm)

(mW)

(MPa)

1.2

n/a

3.0

F4

4MHz

eF THE

100

266

3.1

1000

0.38

4.3

1.7

2.5

n/a

-

Scan

n/a

3.0

F6

5MHz

eF EPHD

90

2.6

4.5

0.57

1.1

4.8

12

0.27

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

3.0

F4

5MHz

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

-

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

99.6

F2

5MHz

PENET

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

-

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

Flow Filter

Triplex Velocity Range

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

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)

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

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

123

F4

4MHz

PENET

25

HIGH

9.0

F1

8MHz

Off

83

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)

(MHz)

(cm)

(mW)

(MPa)

n/a

0.50

F4

4MHz

PENET

n/a

13.0

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

-

Scan

n/a

0.57

F2

5MHz

PENET

n/a

13.0

n/a

Off

99

3.4

0.50

0.57

0.22

5.0

12

0.29

n/a

-

n/a

-

n/a

-

A aprt<1cm A aprt>1cm

2

Non-scan

TIS 2

TIB

n/a

0.76

F2

5MHz

PENET

n/a

13.0

n/a

Off

96

0.27

0.57

0.22

5.0

0.25

0.23

12

1.0

Nonscan

n/a

0.57

F2

5MHz

PENET

n/a

13.0

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

-

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

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

-

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

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)

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

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

15

#5

HIGH

MID

0.12

F2

4MHz

PENET

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)

(MHz)

(cm)

(mW)

(MPa)

1.2

n/a

15

#5

HIGH

MID

0.69

F2

4MHz

PENET

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

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

-

A aprt<1cm A aprt>1cm

2

Non-scan

TIS 2

TIB

n/a

-

n/a

-

Nonscan

n/a

15

#5

HIGH

MID

0.12

F2

4MHz

PENET

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

-

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

-

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

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

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)

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

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)

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

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

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

25

HIGH

4.0

F8

5MHz

-

100

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

25

HIGH

4.0

F5

5MHz

-

100

80

n/a

25

HIGH

4.0

F8

5MHz

-

100

2.9

5.3

n/a

-

n/a

-

A aprt<1cm A aprt>1cm

2

Non-scan

TIS 2

TIB

n/a

-

Nonscan

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

-

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

-

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

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

Flow Filter

Triplex Velocity Range

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

(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)

Other

Y

X

(MHz)

(cm)

(MPa)

0.80

Dim of A aprt

f awf

d eq(z b)

z at max. I pi,α

(cm)

(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)

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

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

66.4

F1

5MHz

PENET

n/a

-

100

n/a

66.4

F1

5MHz

PENET

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

4.0

F5

5MHz

-

100

80

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

-

A aprt<1cm A aprt>1cm

2

Non-scan

TIS 2

TIB

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

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

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

-

2.9

(W/cm ) (cm)

1.4

1000

0.16

4.8

-

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

49.8

F8

5MHz

PENET

n/a

-

70

-

Focal Length FLx

2

(μsec) (Hz)

(cm)

(MHz)

2.5

0.99

0.45

MI

M-mode

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

n/a

-

n/a

-

2.9

0.63

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

Flow Filter

Triplex Velocity Range

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

28.5

(cm/sec)

Doppler Velocity Range

Color Image Select

F5

Doppler Focus

5MHz

(MHz)

Doppler Frequency Select

n/a

PENET

(%)

(cm)

Doppler Image Select

conditions B/W Scan Area

control

Operating

n/a

(MHz)

B/W Frequency Select

100

-

(cm) (%)

-

(W/cm ) (cm)

103 -

Other

Y

X

(cm)

0.80

Dim of A aprt

f awf

(cm)

(MPa)

2

0.27

0.80

4.9 0.28

d eq(z b)

z at max. I pi,α

(cm)

(mW)

(MPa)

d eq at max. I pi

(cm) 5.3

4.9 0.28

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

1.8

-

19

0.87

(MPa)

0.80

1.2

4.8

0.28

0.30

19

1.4

Index label

td

Function

DVA%

FLy

Focal Length FLx

information I pa,α at max.MI

Other

prr p r at max. I pi

-

TIB Nonscan

prr p r at max. I pi

(cm)

Y

4.9

24

0.55

2

0.70

(cm)

Dim of A aprt

-

A aprt<1cm A aprt>1cm

2

Non-scan

TIS

3720

(MHz) X

f awf

2.6

1.3

0.57

Scan

UST-984-5 Table 201.103 – Acoustic output reporting table

(μsec) (Hz)

(cm)

td

(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-984-5

Prosound 6

1 Acoustic Output Tables 1-3 Acoustic Output Tables

MN1-5860 rev.1

MN1-5860 rev.1 Index label

(mW)

(MHz) (cm) (cm)

X Y

f awf

Dim of A aprt

1.8

(cm)

d eq at max. I pi

B/W Focus

B/W Line Density

B/W-Range

F1 4.0

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

88.5

F4

3.64MHz

PENET

25

HIGH

15.0

F1

6.67MHz

-

98

n/a

66.4

F2

5MHz

PENET

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

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)

(MHz)

(cm)

(mW)

(MPa)

n/a

0.44

F6

3.64MHz

PENET

n/a

8.0

n/a

-

100

58

1.4

4210

1.0

3.8

2.6

1.1

0.55

n/a

-

n/a

-

n/a

-

Scan

n/a

0.44

F8

3.64MHz

PENET

n/a

8.0

n/a

-

97

2.6

4.9

0.80

1.2

3.8

25

0.44

n/a

-

n/a

-

n/a

-

A aprt<1cm A aprt>1cm

2

Non-scan

TIS 2

TIB

PENET

n/a

8.0

n/a

-

100

2.6

0.75

0.80

0.35

3.8

18

0.76

TIC

n/a

0.84

F4

n/a

0.89

F2

3.64MHz 3.64MHz

PENET

n/a

8.0

n/a

-

88

0.22

0.80

0.56

3.8

0.24

1.9

21

1.2

Nonscan

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

-

2.9

0.75

0.80

0.35

4.6, 4.9

20

0.79

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

83.9

F8

5MHz

PENET

25

HIGH

11.0

F8

6.67MHz

-

73

-

0.22

0.80

0.56

3.8

0.24

1.9

21

1.2

Index label

Operating Mode:

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

n/a

-

2.9

5.3

TIB Nonscan

UST-984-5 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

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

39.8

(cm/sec)

Doppler Velocity Range

Color Image Select

F5

Doppler Focus

5MHz

25

HIGH

Doppler Frequency Select

(MHz)

5MHz

PENET

(%)

(cm)

(MHz)

100

-

(cm) (%)

-

(W/cm ) (cm)

Doppler Image Select

conditions B/W Scan Area

control

Operating

B/W Frequency Select

Function

DVA%

FLy

Focal Length FLx

103

5080

(MPa)

prr p r at max. I pi 2

-

2

prr p r at max. I pi

0.80

1.2

4.8

24

0.55

A aprt<1cm A aprt>1cm

2

Non-scan

TIS

td

-

Scan

0.70

4.9

2.6

1.3

0.57

(μsec) (Hz)

information I pa,α at max.MI

Other

(cm)

td

(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-984-5

Prosound 6

1 Acoustic Output Tables 1-3 Acoustic Output Tables

1-13

1-14 Index label

(mW)

d eq at max. I pi

B/W Focus

B/W Line Density

B/W-Range

TIC

F8

n/a

-

n/a

15

#5

HIGH

MID

0.12

F3

3.64MHz

PENET

n/a

25

HIGH

4.0

F2

3.64MHz

-

97

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)

PENET

n/a

25

HIGH

13.0

F2

5.71MHz

-

89

2.6

4.9

n/a

15

#5

HIGH

MID

0.61

F6

n/a

15

#5

HIGH

MID

0.66

F8

3.64MHz 3.64MHz

PENET

n/a

25

HIGH

15.0

F2

5MHz

-

100

58

n/a

-

n/a

-

n/a

-

n/a

-

A aprt<1cm A aprt>1cm

2

Non-scan

TIS 2

TIB

n/a

-

n/a

-

Nonscan

n/a

15

#5

HIGH

MID

0.12

F3

3.64MHz

PENET

n/a

25

HIGH

4.0

F2

3.64MHz

-

97

2.6

1.3

0.80

0.95

3.8, 4.4

22

0.57

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

-

2.6

1.3

1.4

0.80

1.7

3.8, 5.1

26

0.47

Scan

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

n/a

-

n/a

-

2

5570

1.0

3.8

2.6

1.1

0.55

MI

B/Bflow-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

0.66

-

n/a

-

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

15

(%)

#5

Triplex Velocity Range

Flow Scan Area

Color Average

Flow Filter

MID HIGH

Color Line Density

F6 0.61

(m/sec)

PENET

n/a

25

HIGH

13.0

F2

5.71MHz

-

89

3.64MHz 3.64MHz

Color Velocity Range

(MHz)

Flow Focus

Color Doppler Frequency Select

PENET

n/a

(cm/sec)

Doppler Velocity Range

Color Image Select

n/a

(MHz)

Doppler Focus

Doppler Frequency Select

25

HIGH

15.0

F2

5MHz

n/a

(%)

(cm)

(MHz)

-

100

2.6

(cm) (%)

4.9

58

(W/cm ) (cm)

2

(μsec) (Hz)

(cm)

Other

Y

X

(MHz)

(cm)

(MPa)

0.80

Dim of A aprt

f awf

d eq(z b)

z at max. I pi,α

(cm)

(mW)

(MPa)

d eq at max. I pi

(cm) -

-

0.95

3.8, 4.4

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

-

22

0.57

(MPa)

-

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

1.7

3.8, 5.1

-

2

1.0

(cm)

X

Dim of A aprt

3.8

26

0.47

A aprt<1cm A aprt>1cm

2

Non-scan

TIS

5570

(MHz)

f awf

2.6

1.1

0.55

Scan

UST-984-5 Table 201.103 – Acoustic output reporting table

(μsec) (Hz)

(cm)

td

(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-984-5

Prosound 6

1 Acoustic Output Tables 1-3 Acoustic Output Tables

MN1-5860 rev.1

ALOKA

ALOKA ProSound Ultrasound Systems

prosound -α 6 Instruction Manual Power Data Book rev 1