FujiFilm SonoSite Edge II Bedienungsanleitung

User Guide Errata

SonoSite, SonoSite Edge, and the SonoSite logo are registered and unregistered trademarks of FUJIFILM SonoSite, Inc. in various

jurisdictions.

All other trademarks are the property of their respective owners.

Part Number: P19439-02

Publication Date: November 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.

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Document conventions 1

English Deutsch Español Français Italiano Português Nederlands

SonoSite Edge II Ultrasound System

User Guide Errata

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

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

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

Saving images and clips ................................................................................................................................ 2

Measurement references .............................................................................................................................. 2

Measurement publications and terminology ............................................................................................................................... 2

Cleaning and disinfecting .............................................................................................................................. 5

Before getting started .............................................................................................................................................................................. 6

Determining the required cleaning and disinfecting level .................................................................................................... 6

Clean and disinfect system and transducer to a high level (semi-critical uses) ....................................................... 7

Clean and disinfect system and transducer to a low level (non-critical uses) ........................................................ 13

Storing the transducer ............................................................................................................................... 16

Transporting the transducer ...................................................................................................................... 16

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 user guide.

2Getting Help

Getting Help

For technical support, please contact FUJIFILM SonoSite as follows:

Printed in the U.S.

The following content was either not included or incorrect in the system user guide; the revisions will be

made in the next update.

Saving images and clips

The percentage icon in the system status area shows the percentage of space available in internal storage.

Measurement references

The following measurement references have been corrected.

Measurement publications and terminology

Effective Regurgitant Orifice (ERO) in mm2

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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Measurement publications and terminology 3

English Deutsch Español Français Italiano Português Nederlands

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

and Wilkins, (2007), 73-76, 210.

ERO = MV Flow Rate/MR Vel * 100

Ejection Fraction (EF), percent

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

(2007), 115-116.

EF = ((LVEDV – LVESV)/LVEDV) * 100%

where: EF = Ejection Fraction

LVEDV = Left Ventricular End Diastolic Volume

LVESV = Left Ventricular End Systolic Volume

Elapsed Time (ET) in msec

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

(2007), p.147, 148, figure 9-8

ET = time between velocity cursors in milliseconds

Left Atrial Volume

Lang R. et al. “Recommendations for Cardiac Chamber Quantification: A report from the American Society

of Echocardiography’s Guidelinesand Standards Committee and the Chamber Quantification Writing Group,

Developed in Conjunction with the European Association of Echocardiography, a Branch of the European

Society of Cardiology.” J Am Soc Echocardiography (2005), 18:1440-1463.

Lang R, Bierig M, Devereux R, et al. “Recommendations for Cardiac chamber Quantification by

Echocardiography in Adults: An Update from the American Society of Echocardiography and the European

Association of Cardiovascular Imaging.” J Am Soc Echocardiography (2015), 28:1-39.

LA Vol = π/4(h) Σ(D1)(D2)

where: LA Vol = Left Atrial Volume in ml

h = Height of stacked oval disks making up the LA

D1 = Orthogonal minor axis

D2 = Orthogonal major axis

2-plane Simpson’s rule (method of disks)

LA Vol = π/4(h) Σ(D1)(D2)

4Measurement publications and terminology

Simpson’s algorithm divides the LA into a series of stacked oval disks where h is the height of the stacked

disks and D1 and D2 are the orthogonal minor and major axes

1-plane Simpson’s rule (method of disks)

LA Vol =π/4(h) Σ(D1)2

Same as the 2-plane method of disks except there is an assumption that the stacked disks are circular.

The equation for the LA Vol Index is: LA Vol Index = LA Vol/BSA

MV Flow Rate in cc/sec

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

Wilkins, (2007), 73-76, 210.

Flow = PISA * Va

where: PISA = Proximal Isovelocity SurfaceArea

Va = aliasing velocity

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), 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.

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Measurement publications and terminology 5

English Deutsch Español Français Italiano Português Nederlands

PG mean = sum(4v2)/N

where: v =peak velocity at interval n

N = the number of intervals in the Riemann sum.

Pressure Half Time (PHT) in msec

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

(2007), 73-74.

PHT = DT * 0.29

where: DT = deceleration time

Regurgitant Fraction (RF) in percent

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

and Wilkins, (2007), 215-217.

RF = RV/ MV SV

where: RV = Regurgitant Volume

MV SV = Mitral Stroke Volume (Mitral CSA * Mitral VTI)

Mitral CSA = cross-sectional area calculated using Annulas Diameter

Regurgitant Volume (RV) in cc

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

and Wilkins, (2007), 215-217.

RV = ERO * MR VTI/100

Cleaning and disinfecting

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

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

transducer. Use the cleaning recommendations in the peripheral manufacturer’s instructions when cleaning

or disinfecting your peripherals.

6Before getting started

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.

Caution 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 chapter 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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Clean and disinfect system and transducer to a high level (semi-critical uses) 7

English Deutsch Español Français Italiano Português Nederlands

The level of cleaning and disinfecting required for the system is dictated by the type of tissue it contacts

during use. Use Table 1

to determine the level of cleaning and disinfecting required.

Spaulding classifications

Spaulding classifications (non-critical, semi-critical) determine the approach for cleaning and disinfecting

medical equipment based on the device, the way it has been used, and the risk of infection. The system and

transducers are designed for use within the Spaulding classifications of non-critical and semi-critical uses.

Clean and disinfect system and transducer to a high level

(semi-critical uses)

Use this procedure to clean and high-level disinfect the ultrasound system and transducer whenever it has

come into contact with blood, broken skin, mucosal membranes, or bodily fluids.

Table 1: Choosing a cleaning and disinfecting method

Did any part of the system or transducer come in contact with broken skin, blood, mucosal

membranes, or bodily fluids?

YES Came in contact with broken

skin, blood, mucosal membranes,

or bodily fluids.

Go to “Clean and disinfect system and

transducer to a high level (semi-critical

uses)” on page 7.

NO Did not come in contact with

broken skin, blood, or bodily

fluids.

Go to “Clean and disinfect system and

transducer to a low level (non-critical

uses)” on page 13.

Option A

Option

8Clean and disinfect system and transducer to a high level (semi-critical uses)

Follow the manufacturer's instructions when using cleaners and disinfectants. The cleaners and disinfectants

listed in the procedure are both chemically compatible and have been tested for efficacy with the system

and transducers. Confirm that the cleaners and disinfectants are appropriate for your facility’s use.

To clean and disinfect the system and transducer

1 Turn off the system by pressing the Power button.

2Unplugthe power cord from the outlet.

3Removethe disposable transducer sheath, if applicable.

4 Disconnect the transducer from the system. Temporarily place it where it will not cross-contaminate

clean equipment or surfaces while you clean the ultrasound console.

5Cleanthe exterior surfaces of the ULTRASOUND SYSTEM to remove any debris or bodily fluids. Use the

following procedure:

WARNINGS To avoid electrical shock, before cleaning, disconnect the system from the power

supply.

Wear the appropriate personal protective equipment (PPE) recommended by the

chemical manufacturer, such as eyewear and gloves.

Caution Do not skip any steps or abbreviate the cleaning and disinfecting process in any

way.

Do not spray cleaners or disinfectants directly on the system surfaces or on

system and transducer connectors. Doing so

may cause solution to leak into the

system, damaging it and voiding the warranty.

Do not attempt to disinfect a transducer or transducer cable using a method or

chemical that is

not included here. This can damage the transducer and void the

warranty.

Use only FUJIFILM SonoSite recommended cleaners and disinfectants. Using a

non-

recommended disinfecting solution or incorrect solution strength can

damage the System and transducer and void the warranty. Follow the

disinfectant manufacturer’s recommendations for solutions strengths.

Note You must clean and disinfect both the ultrasound system and the transducer after

each use, but only the transducer can be disinfected to a high level.

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