FujiFilm SONOSITE X-PORTE Betriebsanleitung

Simultaneous Doppler Imaging

User Guide Supplement

SonoSite, SonoMB, X-Porte, and the SonoSite logo are registered and unregistered trademarks of FUJIFILM SonoSite, Inc. in various

jurisdictions. Value from Innovation is a trademark of FUJIFILM Holdings America Corporation.

All other trademarks are the property of their respective owners.

Part number: P19437-01

Publication date: January 2017

Manufacturer

FUJIFILM SonoSite, Inc.

21919 30th Drive SE

Bothell, WA 98021 USA

T: 1-888-482-9449 or

1-425-951-1200

F: 1-425-951-1201

EC Authorized Representative

Emergo Europe

Molenstraat 15

2513 BH, The Hague

The Netherlands

Australia Sponsor

FUJIFILM SonoSite Australasia Pty Ltd

114 Old Pittwater Road

BROOKVALE, NSW, 2100

Australia

Caution United States federal law restricts this device to sale by or on the order of a

physician.

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Introduction 1

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SonoSite X-Porte Simultaneous Doppler Imaging

User Guide Supplement

Introduction ..................................................................................................................................................... 1

Document conventions ........................................................................................................................................................................... 1

Getting help ................................................................................................................................................................................................... 2

Simultaneous Doppler imaging .................................................................................................................... 2

Intended uses ............................................................................................................................................................................................... 2

Scanning .......................................................................................................................................................................................................... 3

Acoustic output .............................................................................................................................................. 5

Output display ............................................................................................................................................................................................. 5

Transducer surface temperature rise ............................................................................................................................................... 5

Acoustic output tables ............................................................................................................................................................................. 6

Introduction

Document conventions

The document follows these conventions:

A WARNING describes precautions necessary to prevent injury or loss of life.

A Caution describes precautions necessary to protect the products.

A Note provides supplemental information.

Numbered and lettered steps must be performed in a specific order.

Bulleted lists present information in list format but do not imply a sequence.

Single-step procedures begin with .

For a description of labeling symbols that appear on the product, see "Labeling Symbols" in the ultrasound

system user guide.

2Simultaneous Doppler imaging

Getting help

For technical support, please contact FUJIFILM SonoSite as follows:

Printed in the U.S.

Simultaneous Doppler imaging

This user guide supplement describes the simultaneous Doppler imaging feature on the SonoSite X-Porte

ultrasound system.

Intended uses

Simultaneous Doppler imaging assesses body structures simultaneously in two modes: 2D and PW Doppler,

or three modes: 2D, Color, and PW Doppler.

The system is used with a transducer attached and is powered either by battery or by AC electrical power.

The clinician is positioned beside the patient and places the transducer onto the patient’s body where

needed to obtain the desired ultrasound image.

The system transmits ultrasound energy into the patient's body to obtain ultrasound images as listed in the

following section.

Phone

(U.S. or Canada)

877-657-8118

Phone

(outside U.S. or

Canada)

425-951-1330, or call your local representative

Fax 425-951-6700

Email ffss-service@fujifilm.com

Web www.sonosite.com

Europe Service Center Main: +31 20 751 2020

English support: +44 14 6234 1151

French support: +33 1 8288 0702

German support: +49 69 8088 4030

Italian support: +39 02 9475 3655

Spanish support: +34 91 123 8451

Asia Service Center +65 6380-5581

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Simultaneous Doppler imaging 3

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Arterial and venous imaging applications

You can assess the carotid arteries, deep veins and arteries in the arms and legs, superficial veins in the arms

and legs, great vessels in the abdomen, and various small vessels feeding organs for the presence or

absence of pathology.

Transducers and exam types available

Simultaneous Doppler imaging is available only on the transducers and exam types listed in Tab le 1.

Scanning

Simultaneous Doppler imaging is off by default.

To perform a scan using simultaneous Doppler

1Tap TRANSDUCERS & EXAMS at the top of the touch panel.

Cards for the available transducers appear.

2On the card for the appropriate transducer, do one of the following:

Double-tap the exam type.

Tap the exam type, and then tap SCAN.

Scrolling through the list displays available exam types.

WARNING The PW Doppler sensitivity and waveform appearance in simultaneous Doppler

may be inferior to that in non-simultaneous (update) Doppler imaging modes. You

can turn off simultaneous imaging to confirm Doppler waveform characteristics.

Table 1: Transducers and exam types available with simultaneous Doppler imaging

Transducer Arterial Venous

HFL38xp

HSL25xp

L25xp

L38xp

4Simultaneous Doppler imaging

3Tap Doppler to begin imaging.

Position and adjust the D-line and gate. Refer to the SonoSite X-Porte User Guide.

4Tap Start or Update to display the spectral trace.

5Tap Simultaneous. When Simultaneous is available, the control is highlighted.

If this control is hidden, tapping More Controls displays it.

6The image now scans simultaneously in 2D/PW Doppler, or 2D, Color, and PW Doppler.

7Tap More Controls to display and adjust specific controls for each of the three modes.

To view frames in the cine buffer in simultaneous Doppler

1Freeze the image.

2Do either of the following:

Drag the slider. Right moves forward, and left moves backward.

While the slider bar represents the complete set of collected imaging data, the scrolling display shows

only one cycle of imaging data at a time. The green CINE marker ( ) indicates a single column on the

scrolling display, which corresponds in time to the displayed image.

Drag the slider. Right moves forward, and left moves backward.

Tap or to move forward or backward through frames one at a time.

Tapping these controls moves the green CINE marker ( ), showing a column on the scrolling display

and its corresponding image.

Note Tapping Update toggles the display of 2D, Color, and Doppler controls and

calculations.

Note The Simultaneous control can only be found in the Doppler controls.

Note Full screen display is unavailable in simultaneous Doppler mode.

Note You can customize an exam type to display the Simultaneous control button by

default. Refer to the SonoSite X-Porte User Guide for instructions on how to

customize exams.

Simultaneous

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Acoustic output 5

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Acoustic output

Guidelines for reducing MI and TI

Refer to the tables in this section of the SonoSite X-Porte User Guide.

Output display

Transducer surface temperature rise

Refer to the tables in this section of the SonoSite X-Porte User Guide.

Table 2: TI or MI ≥ 1.0

Transducer Model Index 2D + PW Doppler 2D + Color + PW

Doppler

HFL38xp MI No Yes

TIC, TIB, or TIS Yes Yes

HSL25xp MI Yes Yes

TIC, TIB, or TIS No No

L25xp MI Yes Yes

TIC, TIB, or TIS No No

L38xp MI Yes Yes

TIC, TIB, or TIS Yes Yes

Even if MI is less than 1.0, the system provides a continuous real-time display of MI in all imaging modes, in

increments of 0.1.

The system meets the output display standard for TI and provides a continuous real-time display of TI in all imaging

modes, in increments of 0.1.

The TI consists of three user-selectable indices, and only one of these is displayed at any one time. In order to

display TI properly and meet the ALARA principle, the user selects an appropriate TI based on the specific exam

being performed. FUJIFILM SonoSite provides a copy of AIUM Medical Ultrasound Safety, which contains

guidance on determining which TI is appropriate (see “Related guidance documents” on page 14).

6Acoustic output

Acoustic output tables

Table 3: Transducer Model: HFL38xp, Operating Mode: 2D + PW Doppler

Index Label M.I.

TIS TIB

TIC

Scan Non-scan Non-

scan

Aaprt≤1 Aaprt>1

Global Maximum Index Value (a) 1.0 1.5 (b)

Associated

Acoustic

Parameter

pr.3 (MPa) #

W0(mW) 1.79 32.9 30.0 #

min of [W.3(z1),ITA .3 (z1)] (mW) -

z1(cm) -

Zbp (cm) -

Zsp (cm) 1.63

z@Pll.3max (cm) #

deq(Zsp)(cm) 0.24

Fc(MHz) #8.72 5.97 -5.97 #

Dim of Aaprt X (cm) 0.84 1.20 -0.96 #

Y (cm) 0.40 0.40 -0.40 #

Other

Information

PD (μsec) #

PRF (Hz) #

pr@PIImax (MPa) #

deq@Pllmax (cm) 0.18

Focal Length FLx(cm) 2.79 4.68 - #

FLy(cm) 2.50 2.50 - #

IPA.3@MImax (W/cm2)#

Operating

Control

Conditions

Control 1: Exam Type Venous Venous

Control 2: 2D Optimization Gen Gen

Control 3: Depth 5.6 cm 4.4 cm

Control 4: Sample Volume Size 1 mm 1 mm

Control 5: Sample Volume

Position

Zone 11 Zone 9

Control 6: PW PRF 10417 Hz 5208 Hz

(a) This index is not required for this operating mode; value is <1.

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

# No data are reported for this operating condition since the global maximum index value is not reported for the

reason listed. (Reference Global Maximum Index Value line.)

- Data are not applicable for this transducer/mode.

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Acoustic output 7

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Table 4: Transducer Model: HFL38xp, Operating Mode: 2D + Color + PW Doppler

Index Label M.I.

TIS TIB

TIC

Scan Non-scan Non-

scan

Aaprt≤1 Aaprt>1

Global Maximum Index Value 1.1 1.0 1.3 (b)

Associated

Acoustic

Parameter

pr.3 (MPa) 2.67

W0(mW) 12.0 22.5 12.4 #

min of [W.3(z1),ITA.3(z1)] (mW) -

z1(cm) -

Zbp (cm) -

Zsp (cm) 0.40

z@Pll.3max (cm) 1.1

deq(Zsp)(cm) 0.21

Fc(MHz) 5.90 5.89 5.97 -6.00 #

Dim of Aaprt X (cm) 1.72 1.20 -0.24 #

Y (cm) 0.40 0.40 -0.40 #

Other

Information

PD (μsec) 0.63

PRF (Hz) 4196

pr@PIImax (MPa) 3.32

deq@Pllmax (cm) 0.16

Focal Length FLx(cm) 4.4 4.7 - #

FLy(cm) 2.5 2.5 - #

IPA.3@MImax (W/cm2)415

Operating

Control

Conditions

Control 1: Exam Type Arterial Venous Venous

Control 2: 2D Optimization Gen Gen Gen

Control 3: Depth 5.6 cm 5.6 cm 1.5 cm

Control 4: Colorbox Size/Position Wide/

Default

Narrow/Default Wide/

Default

Control 5: Sample Volume Size 3 mm 1 mm 1 mm

Control 6: Sample Volume

Position

Zone 2 Zone 11 Zone 0

Control 7: PW PRF 10417

10417 Hz 15625

(a) This index is not required for this operating mode; value is <1.

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

# No data are reported for this operating condition since the global maximum index value is not reported for the

reason listed. (Reference Global Maximum Index Value line.)

- Data are not applicable for this transducer/mode.

8Acoustic output

Table 5: Transducer Model: HSL25xp, Operating Mode: 2D + PW Doppler

Index Label M.I.

TIS TIB

TIC

Scan Non-scan Non-

scan

Aaprt≤1 Aaprt>1

Global Maximum Index Value 1.1 (a) (a) (b)

Associated

Acoustic

Parameter

pr.3 (MPa) 2.98

W0(mW) # # # #

min of [W.3(z1),ITA.3(z1)] (mW) -

z1(cm) -

Zbp (cm) -

Zsp (cm) #

z@Pll.3max (cm) 1.00

deq(Zsp)(cm) #

Fc(MHz) 6.81 # # - # #

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

Y (cm) # # - # #

Other

Information

PD (μsec) 0.19

PRF (Hz) 7670

pr@PIImax (MPa) 3.77

deq@Pllmax (cm) #

Focal Length FLx(cm) # # - #

FLy(cm) # # - #

IPA.3@MImax (W/

cm2)

374

Operating

Control

Conditions

Control 1: Exam Type Venous

Control 2: 2D Optimization Gen

Control 3: Depth 2.0 cm

Control 4: Sample Volume Size 1 mm

Control 5: Sample Volume

Position

Zone 0

Control 6: PW PRF 1562 Hz

(a) This index is not required for this operating mode; value is <1.

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

# No data are reported for this operating condition since the global maximum index value is not reported for the

reason listed. (Reference Global Maximum Index Value line.)

- Data are not applicable for this transducer/mode.

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