FujiFilm SonoSite Edge II User manual

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
Copyright © 2016 FUJIFILM SonoSite, Inc. All Rights reserved.
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 [phone]
Email [e-mail]
Web www.sonosite.com
Europe Service Center Main: [phone]
English support: [phone]
French support: [phone]
German support: [phone]
Italian support: [phone]
Spanish support: [phone]
Asia Service Center [phone]

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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.
OR
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
B
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.