FujiFilm SONOSITE X-PORTE Betriebsanleitung

rP19xp Transducer

User Guide Supplement

SonoSite, 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.

Patents: US 9,151,832; US 8,956,296; US 8,861,822; US 8,834,372; US 8,805,047; US 8,355,554; US 8,216,146; US 8,213,467; US

8,137,278; US 8,088,071; US 8,066,642; US 7,804,970; US 7,740,586; US 7,604,596; US 7,449,640; US 7,169,108; US 6,962,566;

US 6,648,826; US 6,471,651; US 6,416,475; US 6,383,139; US 6,364,839; US 6,203,498; US 6,135,961; US 5,893,363; US

5,817,024; US 5,782,769; US 5,722,412; AU 727381; AU 730822; CA 2,371,711; CA 2,372,152; CN 103237499; CN 101231457;

CN 97113678.5; CN 98106133.8; CN 98108973.9; DE 60029777.2; DE 60034670.6; DE 69730563.5; DE 69830539.6; DE

69831698.3; EP 0815793; EP 0875203; EP 0881492; EP 1180971; EP 1180970; ES 0881492; ES 2229318; FR 0815793; FR

0875203; FR 0881492; FR 1180970; GB 0815793; GB 0875203; GB 0881492; GB 1180970; GB 1180971; IT 0815793; IT 0881492;

JP 5972258; JP 5782428; JP 4696150; KR 528102; KR 532359; NO 326814 and NO 326202.

Part number: P23130-01

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 rP19xp Transducer User Guide

Supplement

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

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

Getting Help .................................................................................................................................................................................................. 2

Imaging modes ................................................................................................................................................ 3

Cleaning and disinfecting .............................................................................................................................. 4

Safety ............................................................................................................................................................... 4

Compatible accessories and peripherals ........................................................................................................................................ 5

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

Guidelines for reducing MI and TI ..................................................................................................................................................... 5

Output display ............................................................................................................................................................................................. 6

Acoustic output tables ............................................................................................................................................................................. 7

Introduction

This user guide supplement provides information on the rP19xp transducer, compatible with the SonoSite

X-Porte ultrasound system.

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.

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

system user guide.

2Introduction

Getting Help

For technical support, please contact FUJIFILM SonoSite as follows:

Printed in the U.S.

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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Imaging modes 3

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Imaging modes

Table 1: Available exam types and imaging modes

Transducer Exam type

Imaging mode

M Mode ColoraPW

Dopplerb

Doppler

rP19xp Abdomen CVD, CPD —

Cardiac CVD, Var

Lung CVD, CPD —

Obstetrics CVD, CPD —

Orbital CVD, CPD —

Transcranial CVD, CPD —

aVar = Color Doppler Variance, which is available in the cardiac exam only. CPD = Color Power

Doppler, which is available in all exams except the cardiac exam type. CVD = Color Velocity Doppler.

bFor the cardiac exam type, PW TDI is also available.

Note The rP19xp transducer is needle guide-capable. For more information, refer to

Using CIVCO Products with FUJIFILM SonoSite Systems.

4Cleaning and disinfecting

Cleaning and disinfecting

Safety

Table 2: Approved cleaners

Product Compatible transducer Minimum wet contact timea

SaniCloth AF3brP19xp 3 minutes

PI-Spray II rP19xp 10 minutes

aFor maximum effectiveness, the component being cleaned must remain wet with disinfectant for a minimum

period of time.

bQualified for use as an intermediate-level disinfectant for mycobacteria.

Refer to the cleaners and disinfection document available at www.sonosite.com for a complete list of the most

current cleaners and disinfectants.

Table 3: Approved high-level compatible disinfectants

DisinfectantaCompatible transducer Temperature Disinfectant soak duration

Cidex rP19xp 25oC, 77oF45 minutes

Cidex OPA rP19xp 20oC, 68oF12 minutes

aRefer to the cleaners and disinfection document available at www.sonosite.com for a complete list of the most

current cleaners and disinfectants.

WARNING To avoid device damage or patient injury, do not use the rP19xp needle-guide

bracket on patients with pacemakers or medical electronic implants. The needle-

guide bracket for rP19xp contains a magnet that is used to ensure that the bracket

is correctly oriented on the transducer. The magnetic field in direct proximity to the

pacemaker or medical electronic implant may have an adverse effect.

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Acoustic output 5

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Compatible accessories and peripherals

Acoustic output

Guidelines for reducing MI and TI

Table 4: Accessories and peripherals

Description Maximum Cable Length

rP19xp transducera6.0 ft /1.8 m

aFor transducers, maximum cable length is measured between the strain reliefs. The stated lengths do not include

the lengths of cable in the following locations: underneath the strain reliefs, inside the transducer enclosure, or inside

the transducer connector.

Table 5: Guidelines for reducing mechanical index (MI)

Transducer Depth

rP19xp

Decrease or lower setting of parameter to reduce MI.

Increase or raise setting of parameter to reduce MI.

6Acoustic output

Output display

Table 6: Guidelines for reducing thermal index (TI)

Transducer

CPD Settings PW

Settings

Box

Width

Box

Height

Box

Depth PRF Depth Optimize

rP19xp

(PRF)

Decrease or lower setting of parameter to reduce TI.

Increase or raise setting of parameter to reduce TI.

Table 7: TI or MI ≥1.0

Transducer Index 2D/

M Mode

CPD/

Color

Doppler

rP19xp MI Yes Yes Yes No

TIC, TIB, or TIS Yes Yes Yes Yes

Table 8: Transducer Surface Temperature Rise, External Use (°C )

Test rP19xp

Still air 15.8

Simulated use 8.8

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Acoustic output 7

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Acoustic output tables

Table 9: Transducer Model: rP19xp Operating Mode: 2D

Index Label M.I.

TIS TIB

TIC

Scan Non-scan Non-scan

Aaprt≤1 Aaprt>1

Global Maximum Index Value 1.5 1.2 — — — 2.9

Associated Acoustic

Parameter

pr.3 (MPa) 1.95

W0(mW) 120.0 — — 190.8

min of [W.3(z1),ITA.3(z1)] (mW) —

z1(cm) —

Zbp (cm) —

Zsp (cm) —

z@PII.3max 2.6

deq(zsp)(cm) —

Fc(MHz) 1.72 2.02 — — — 1.80

Dim of Aaprt X (cm) 1.92 — — — 1.92

Y (cm) 1.15 — — — 1.15

Other Information

PD (μsec) 1.227

PRF (Hz) 2933

pr@PIImax (MPa) 2.30

deq@Pllmax (cm) —

Focal Length FLx (cm) 3.42 — — 3.42

FLy(cm) 9.00 — — 9.00

IPA.3 @MImax (W/cm2)225

Operating

Control

Conditions

Control 1: Exam Type Crd Abd Abd

Control 2: Optimization Gen Pen Gen

Control 3: Depth 7 cm 5 cm 5 cm

Control 4: THI On Off On

Control 5: Sector Width Full N/A N/A

— Data are not applicable for this transducer/mode.

8Acoustic output

Table 10: Transducer Model: rP19xp Operating Mode: M Mode

Index Label M.I.

TIS TIB

TIC

Scan Non-scan Non-scan

Aaprt≤1 Aaprt>1

Global Maximum Index Value 1.5 1.1 0.9 3.0

Associated Acoustic

Parameter

pr.3 (MPa) 1.95

W0(mW) 105 9.8 25.4 180.5

min of [W.3(z1),ITA.3(z1)] (mW) —

z1(cm) —

Zbp (cm) —

Zsp (cm) 3.02

z@PII.3max 2.6

deq(zsp)(cm) 0.444

Fc(MHz) 1.72 2.09 2.09 —1.732 1.75

Dim of Aaprt X (cm) 1.92 0.78 —1.02 1.92

Y (cm) 1.15 1.15 —1.15 1.15

Other Information

PD (μsec) 1.227

PRF (Hz) 2693

pr@PIImax (MPa) 2.30

deq@Pllmax (cm) 0.427

Focal Length FLx (cm) 4.56 4.56 —2.25

FLy(cm) 9.00 9.00 —9.00

IPA.3 @MImax (W/cm2)225

Operating

Control

Conditions

Control 1: Exam Type Crd Abd Crd Abd

Control 2: Optimization Gen Pen Gen Gen

Control 3: Depth 7 cm 7 cm 13 cm 5 cm

Control 4: THI On Off On On

— Data are not applicable for this transducer/mode.

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