FujiFilm SonoSite Edge Betriebsanleitung

User Guide Supplement

SonoSite, the SonoSite logo, Edge, S Series and M-Turbo are trademarks and registered 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: P20272-04

Publication date: January 2016

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.

English Deutsch Español Français Italiano Português

Document conventions 1

Nederlands

SonoSite Edge, SonoSite S Series, SonoSite

M-Turbo User Guide Supplement

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

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

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

Supplemental information (SonoSite Edge) ............................................................................................... 2

Cable diagnostics ........................................................................................................................................................................................ 2

Errata ............................................................................................................................................................... 3

Patents ............................................................................................................................................................................................................. 3

Hazardous materials (SonoSite Edge) ............................................................................................................................................ 4

Electrical safety ............................................................................................................................................................................................ 4

Unexpected data loss .............................................................................................................................................................................. 5

Measurements ............................................................................................................................................................................................. 5

Measurement references ....................................................................................................................................................................... 6

Cleaning and disinfecting ....................................................................................................................................................................... 7

Introduction

The content in this document includes new features, as well as corrections and updates to the user guide.

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 user guide.

2GettingHelp

Getting Help

For technical support, please contact FUJIFILM SonoSite as follows:

Printed in the U.S.

Supplemental information (SonoSite Edge)

The following section provides information supplementing the SonoSite Edge system user guide only.

Cable diagnostics

A cable diagnostic feature has been added to the SonoSite Edge system to prevent malfunctioning

transducer cables from damaging the system. The feature returns one of two different error messages

depending on whether damage has been detected to the system or transducer. Contact FUJIFILM SonoSite

Technical Support for further assistance.

Testing transducer cables for damage

All transducers should be tested after performing a system software upgrade, or after receiving a repaired

system back from SonoSite. This should be done before the system is put back into use.

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 service@sonosite.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

English Deutsch Español Français Italiano Português

Patents 3

Nederlands

The order in which you test transducers is important. Test transducers in the following order:

To test transducer cables for damage

1Any transducer (except the following)

2P21x

3HFL38x

4C60x

5L38x

Errata

The following section provides corrections and updates to the user guide.

Patents

SonoSite Edge system

Patents: US 9,151,832; US 8,956,296; US 8,861,822; US 8,858,436; US 8,834,372; US 8,805,047; US

8,439,840; US 8,398,408; US 8,355,554; US 8,216,146; US 8,213,467; US 8,147,408; US 8,137,278; US

8,088,071; US 8,066,642; US 8,052,606; US 7,819,807; US 7,804,970; US 7,740,586; US 7,686,766; US

7,604,596; US 7,591,786; US 7,588,541; US 7,534,211; US 7,449,640; US 7,169,108; US 6,962,566; US

6,648,826; US 6,575,908; US 6,569,101; 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: 730822; AU:

727381; CA 2,372,152; CA: 2,371,711; CN103237499 B; CN101231457 B; CN 98108973.9; CN

98106133.8; CN 97113678.5; DE 69831698.3; DE 69830539.6; DE 69730563.5; DE 602004027882.3; DE

602004023816.3; DE 60034670.6; DE 60029777.2; EP 1589878; EP 1552792; EP 1180971; EP

0875203; EP 0815793; EP 1180970; EP 0881492; ES 2229318; ES 159878; ES 1552792; ES 0881492;

FR 158978; FR 1552792; FR 1180970; FR 0881492; FR 0875203; FR 0815793; GB 158978; GB 1552792;

GB 1180971; GB 1180970; GB 0881492; GB 0875203; GB 0815793; IT 1589878; IT 1552792; IT

0881492; IT 0815793; JP5782428 (B2); JP 4696150; KR 532359; KR 528102; NO 326814; NO 326202.

4Hazardous materials (SonoSite Edge)

SonoSite M-Turbo system

Patents: US 9,151,832; US 8,956,296; US 8,861,822; US 8,858,436; US 8,834,372; US 8,805,047; US

8,398,408; US 8,355,554; US 8,216,146; US 8,213,467; US 8,164,011; US 8,137,278; US 8,088,071; US

8,066,642; US 7,804,970; US 7,740,586; US 7,686,766; US 7,591,786; US 7,588,541; US 7,534,211; US

7,449,640; US 7,169,108; US 6,962,566; US 6,648,826; US 6,569,101; US 6,471,651; US 6,416,475; US

6,383,139; US 6,371,918; US 6,364,839; US 6,135,961; US 5,893,363; US 5,817,024; US 5,782,769; US

5,722,412; US D538,432; US D509,900; AU 727381; AU 730822; CA 2,371,711; CA 2,372,152; CA

2,373,065; CN103237499 B; CN101231457 B; CN 97113678.5; CN 98106133.8; CN 200830007734.8;

EP 0875203; EP 0881492; EP 1175713; EP 1180970; EP 1180971; EP 1552792; EP 1589878;

JP5782428 (B2); JP 4696150; KR 528102; and KR 532359.

SonoSite S Series system

Patents: US 9,151,832; US 8,956,296; US 8,861,822; US 8,858,436; US 8,834,372; US 8,805,047; US

8,376,103; US 8,216,146; US 8,213,467; US 8,137,278; US 8,066,642; US 7,978,461; US 7,804,970; US

7,740,586; US 7,686,766; US 7,591,786; US 7,588,541; US 7,534,211; US 7,449,640; US 7,169,108; US

6,962,566; US 6,648,826; US 6,569,101; US 6,471,651; US 6,416,475; US 6,383,139; US 6,371,918; US

6,364,839; US 6,135,961; US 5,893,363; US 5,817,024; US 5,782,769; US 5,722,412; USD592,750;

USD591,423; AU 727381; AU 730822; CA 2,371,711; CA 2,372,152; CA 2,373,065; CN103237499 B;

CN101231457 B; CN 97113678.5; CN 98106133.8; CN 200830007734.8; EP 0875203; EP 0881492; EP

1175713; EP 1180970; EP 1180971; EP 1552792; EP 1589878; JP5782428 (B2); JP 4696150; KR

528102; and KR 532359.

Hazardous materials (SonoSite Edge)

Disregard the following warning for the SonoSite Edge ultrasound system only:

Electrical safety

The following warning was added to the other electrical safety warnings in the Safety chapter of the user

guides.

WARNING The liquid crystal display (LCD) contains mercury. Dispose of the LCD properly

in accordance with local regulations.

WARNING Avoid patient contact with any part of the system other than the transducer or

the ECG leads.

English Deutsch Español Français Italiano Português

Unexpected data loss 5

Nederlands

Unexpected data loss

Patient exam calculations on ultrasound workflows can be lost without warning or indication if certain

settings change prior to ending any current (open) studies. See the following caution:

Measurements

To calculate Stroke Volume (SV) or Stroke Index (SI)

1Fill in the Height and Weight fields on the patient information form. The BSA is calculated automatically.

(SI only.)

2Measure from LVOT (2D).

a On a frozen 2D image, press the calcs key.

b From the 2D main menu, select AO/LA.

cFromtheCalculations menu, select LVOT D.

d Position the calipers.

e Save the calculation.

3Measure from LVOT (Doppler).

a On a frozen Doppler image, press the calcs key.

bFromtheCalculations menu, select AV, and then select LVOT VTI.

c Position the calipers.

d Save the calculation.

To calculate Aortic Valve Area (AVA)

The AVA calculation requires a measurement in 2D and two measurements in Doppler. After the

measurements are saved, the result appears in the patient report.

Caution Changes made to any of the following settings will cause analysis values in the

current (open) study to be cleared. These settings should not be changed before

ending any open study on the system.

Date and time

OB tables or custom measurements

Cardiac TDI labels

IMT labels

Doppler units

6Measurementreferences

1In 2D, measure from LVOT:

a On a frozen 2D image, press the calcs key.

bFromtheCalculations menu, select AV then LVOT D.

c Position the calipers.

d Save the calculation.

2In Doppler, select AV, measure LVOT, and then measure the AV.

Measurement references

Aortic Valve Area (AVA) by Continuity Equation in cm2

Oh, J.K., J.B. Seward, and A.J. Tajik. The Echo Manual. 3rd Edition., Philadelphia: Lippincott, Williams, and

Wilkins, (2007), p.73, 191-195.

A2= A1* V1/V2

where:

A2= Ao valve area

A1= LVOT area(CSA)

V1= LVOT velocity(VMax)

V2= Ao valve velocity (VMax)

LVOT = Left Ventricular Outflow Tract

Pressure Gradient (PGr) in mmHG

Oh, J.K., J.B. Seward, and A.J. Tajik. The Echo Manual. 3rd Edition, Philadelphia: Lippincott, Williams, and

Wilkins, (2007), p.63-66.

PGr = 4 * (Velocity)2

Peak E Pressure Gradient (E PG)

E PG = 4 * PE2

Peak A Pressure Gradient (A PG)

A PG = 4 * PA2

Peak Pressure Gradient (PGmax)

PGmax = 4 * PV2

Mean Pressure Gradient (PGmean)

Echocardiographic Assessment of Valve Stenosis: EAE/ASE Recommendations for Clinical Practice Journal

of American Society of Echocardiography, (January, 2009), 4-5.

English Deutsch Español Français Italiano Português

Cleaning and disinfecting 7

Nederlands

PG mean = sum(4v2)/N

where:

v =peak velocity at interval n

N = the number of intervals in the Riemann sum

Qp/Qs

Qp/Qs = SV Qp site/SV Qs site = RVOT SV/LVOT SVOh, J.K., J.B. Seward, and A.J. Tajik. The Echo Manual.

3rd Edition, Boston: Philadelphia: Lippincott Williams and Wilkins, (2007), p.70-72.

where:

RVOT SV = RVOT CSA* RVOT VTI = π/4 * RVOT diameter2 * RVOT VTI

LVOT SV = LVOT CSA * LVOT VTI = π/4 * LVOT diameter 2 * LVOT VTI

Stroke Volume (SV) Doppler in ml

Oh, J.K., J.B. Seward, and A.J. Tajik. The Echo Manual. 3rd Edition, Boston: Philadelphia: Lippincott Williams

and Wilkins, (2007), p.69-71.

SV = (CSA * VTI)

where:

CSA = Cross Sectional Area of the orifice (LVOT area)

VTI = Velocity Time Integral of the LVOT

Cleaning and disinfecting

This section updates the instructions for cleaning and disinfecting the ultrasound system, transducers, and

accessories.

Use the FUJIFILM SonoSite recommendations when cleaning or disinfecting your ultrasound system,

transducer, and accessories. Use the cleaning recommendations in the peripheral manufacturer’s instructions

when cleaning or disinfecting your peripherals.

8Cleaning and disinfecting

See www.sonosite.com/transducers, for transducer images.

Before getting started

Follow the disinfectant manufacturer’s recommendations regarding appropriate personal protective

equipment (PPE), such as protective eyewear and gloves.

Inspect the system and transducer to determine that they are free of any unacceptable deterioration, such

as corrosion, discoloration, pitting, or cracked seals. If damage is evident, discontinue use,and contact

FUJIFILM SonoSite or your local representative.

Confirm that cleaning and disinfecting materials are appropriate for your facility’s use. FUJIFILM SonoSite

tests cleaners and disinfectants for use with the FUJIFILM SonoSite systems and transducers.

Disinfectants and cleaning methods listed in this chapter are recommended by FUJIFILM SonoSite for

efficacy and material compatibility with the products.

Ensure that the disinfectant type and the solution strength and duration are appropriate for the equipment

and application.

Follow manufacturer recommendations and local regulations, when preparing, using and disposing of

chemicals.

Determining the required cleaning and disinfecting level

Notes The system and transducers must becleaned and disinfected after each exam.

It is important to follow these cleaning and disinfecting instructions without

skipping any steps.

For cleaning the TEEx transducer, refer to the cleaning and disinfection

instructions in the TEEx User Guide.

WARNINGS Ensure that cleaning and disinfecting solutions and wipes are not expired.

Some cleaners and disinfectants can cause an allergic reaction to some

individuals.

WARNINGS Ensure that cleaning and disinfecting solutions and wipes are not expired

Some cleaners and disinfectants can cause an allergic reaction to some

individuals

Cautions Do not allow cleaning solution or disinfectant into the system

connectors, or

transducer connector.

Do not use strong solvents such as thinner or benzene, or abrasive cleansers,

since these will damage the exterior surfaces. Use only FUJIFILM SonoSite

recommended cleaners or disinfectants.

WARNING The cleaning instructions contained in this section are based on requirements

mandated by the American Food and Drug Administration (FDA). Failure to

follow these instructions may result in cross contamination and patient infection.

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