FujiFilm SonoSite Edge Owner's manual

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
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.

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 [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]

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.