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
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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.

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Clean and disinfect system and transducer to a high level (semi-critical uses) 9
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aUse either a pre-moistened wipe or a soft cloth dampened with cleaner or disinfectant. Choose a cleaner
from the list of approved cleaners.
bRemove all gel, debris, and bodily fluids from the system.
cWith a new wipe, clean the system, including the display, by wiping from clean areas to the soiled areas.
This method helps to avoid cross-contamination.
dObserve the minimum wet contact time and refer to manufacturer’s instructions. Monitor the system
for wet appearance. Re-apply with a new wipe if no longer wet.
eAllow the ultrasound console to air dry in a clean, well-ventilated space.
6Cleanthe ultrasound system STAND to remove any debris or bodily fluids. For information about cleaning
the stand, see the Edge Stand and H-Universal Stand User Guide.
Approved cleaners/disinfectants for the ultrasound system
Cleaner/disinfectant Minimum wet contact time1
SaniCloth AF323 minutes
SaniCloth Plus 3 minutes
PI-Spray II 10 minutes
1For maximum effectiveness, the component being cleaned must remain wet with disinfectant for a minimum
period of time.
2Qualified for use as an intermediate-level disinfectant for mycobacteria.
Refer to the cleaners and disinfection document available at www.sonosite.com for a more complete list of the
most current cleaners and disinfectants.

10 Clean and disinfect system and transducer to a high level (semi-critical uses)
7Cleanthe TRANSDUCER CABLE AND BODY to remove any debris or bodily fluids. Use the following
procedure:
aUse either a pre-moistened wipe or a soft cloth dampened with cleaner or disinfectant. Choose a cleaner
from the list of approved cleaners.
bRemove all gel, debris, and bodily fluids from the system.
cWith a new wipe, clean the cable and transducer, starting from the cable, wiping toward the scanhead.
This method helps to avoid cross-contamination.
dObserve the minimum wet contact time recommended by the manufacturer. Monitor the transducer
for wet appearance. Re-apply with a new wipe if no longer wet.
Approved cleaners/disinfectants for the transducer
Product Compatible Transducer Minimum wet contact time1
Sani-Cloth AF32C8x, C11x, C35x, HFL38xi,
HFL50x, HSL25x, ICTx, L25x,
L38xi, P10x, P11x3, rC60xi,
rP19x
3 minutes
Sani-Cloth Plus HFL50x, L52x43 minutes
PI-Spray II C8x, C11x, HFL38xi, HFL50x,
HSL25x, ICTx, L25x, L38xi,
L52x4, P10x, P11x3, rC60xi,
rP19x
10 minutes
1For maximum effectiveness, the component being cleaned must remain wet with disinfectant for a minimum
period of time.
2Qualified for use as an intermediate-level disinfectant for mycobacteria.
3 The L52x Transducer is for veterinary use only.
4 The P11x Transducer is not licensed for use in Canada.
Refer to the cleaners and disinfection document available at www.sonosite.com for a more complete list of the
most current cleaners and disinfectants.
Caution Do not allow moisture near the electronic components of the connector.

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Clean and disinfect system and transducer to a high level (semi-critical uses) 11
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8Verifythat all gel, debris, and bodily fluids have been removed from the system and transducer. If
necessary, repeat steps 5, 6 & 7 with a new wipe.
9Examine the system, transducer and cable for damage, such as cracks or splitting where fluid can enter.
If damage is evident, do not use. Instead, contact FUJIFILM SonoSite or your local representative.
10 Prepare the disinfectant for use.
aChoose a high-level disinfectant from the list of approved disinfectants.
bCheck the expiration date on the bottle to ensure the disinfectant has not expired.
cMix or check that the disinfection chemicals have the concentration recommended by the manufacturer
(for example, a chemical strip test).
dCheck that the temperature of the disinfectant is within the manufacturer’s recommended limits.
11 Perform a high-level disinfection of the transducer. Use the following procedure:
aImmerse the transducer in a high-level disinfectant solution.
WARNING Failure to remove all gel, debris, and bodily fluid could leave contaminants on the
probe.
High-level disinfectants compatible with SonoSite Edge II transducers
Disinfectant Compatible transducers Temperature Disinfectant Soak Duration
Cidex C8x, C11x, C35x, HFL38xi,
HFL50x, HSL25x, ICTx, L25x,
L38xi, P10x, P11x1, rC60xi,
rP19x
25°C, 77°F 45 minutes
Cidex OPA C8x, C11x, HFL38xi, HFL50x,
HSL25x, ICTx, L25x, L38xi,
L52x2, P10x, rC60xi, rP19x
20°C, 68°F 12 minutes
1 The P11x Transducer is not licensed for use in Canada.
2 The L52x Transducer is for veterinary use only.
Refer to the cleaners and disinfection document available at www.sonosite.com for a complete list of the most
current cleaners and disinfectants.
WARNING High-level disinfectants can cause harm to the patient if not completely removed
from the transducer. Follow the manufacturer’s rinse instructions to remove
chemical residue.

12 Clean and disinfect system and transducer to a high level (semi-critical uses)
bEnsure that the connector and most of the cable remain out of the fluid. You may submerge 2 inches
(5 cm) of the cable proximal to the transducer scanhead.
Figure 1 Transducer component names
12 Rinse the transducer three separate times using the following procedure:
aRinse the transducer in clean, running water according to the disinfectant manufacturer’s instructions
(at least one minute).
bEnsure that the connector and at least 12-18 inches (31-46 cm) of the cable from the connector remain
dry.
cRepeat this step until the transducer has been rinsed three separate times.
13 Dry the transducer with a sterile lint-free cloth.
14 Dispose of the disinfectant according to the manufacturer’s guidelines.
Caution Do not soak the transducer longer than recommended by the chemical
manufacturer.
Do not immerse the transducer connector in any disinfectant solution.
Use only FUJIFILM SonoSite recommended cleaners and disinfectants. Using a
non-
recommended disinfecting solution or incorrect solution strength can
damage or discolor the transducer and void the warranty.
WARNING High-level disinfectants can cause harm to the patient if not completely removed
from the transducer. Follow the manufacturer’s rinse instructions to remove
chemical residue.
Maximum
5 cm
(2 inches)
Do not submerge
Scan head
Cable
Connector

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Clean and disinfect system and transducer to a low level (non-critical uses) 13
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15 Examine the transducer and cable for damage, such as cracks or splitting where fluid can enter.
If damage is evident, discontinue use of the transducer, and contact FUJIFILM SonoSite or your local
representative.
Clean and disinfect system and transducer to a low level
(non-critical uses)
Use the following procedure to clean and disinfect the ultrasound system and transducer if it has not come
into contact with blood, broken skin, mucosal membranes, or bodily fluids.
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.
WARNING If the system or transducer has come into contact with any of the following, use
the high-level cleaning and disinfection procedure. See “Clean and disinfect
system and transducer to a high level (semi-critical uses)” on page 7:
Blood
Broken skin
Mucosal membranes
Bodily fluids
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 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.
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.
Do not attempt to disinfect a transducer or transducer cable using a method or
chemical that is not included here. Doing so can damager the transducer and void
the warranty.
B
Option

14 Clean and disinfect system and transducer to a low level (non-critical uses)
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 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 system.
5Cleanthe exterior surfaces of the ULTRASOUND SYSTEM to remove any debris. Use the following
procedure:
aUse either a pre-moistened wipe or a soft cloth dampened with cleaner and disinfectant. Choose a
cleaner from the list of approved cleaners.
bRemove all gel and debris from the system.
cWith a new wipe, clean the system, including the display, by wiping from clean areas to the soiled areas.
This method helps to avoid cross-contamination.
dObserve the minimum wet contact time and refer to manufacturer’s instructions. Monitor the system
for wet appearance. Re-apply with a new wipe if no longer wet.
6Cleanthe ultrasound system STAND to remove any debris. For information about cleaning the stand, see
the Edge Stand and H-Universal Stand User Guide.
7Cleanthe TRANSDUCER CABLE AND BODY to remove any debris. Use the following procedure:
Approved cleaners/disinfectants for the ultrasound system:
Cleaner/disinfectant Minimum wet contact time1
SaniCloth AF323 minutes
SaniCloth Plus 3 minutes
PI-Spray II 10 minutes
1For maximum effectiveness, the component being cleaned must remain wet with disinfectant for a minimum
period of time.
2Qualified for use as an intermediate-level disinfectant for mycobacteria.
Refer to the cleaners and disinfection document available at www.sonosite.com for a more complete list of the
most current cleaners and disinfectants.

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Clean and disinfect system and transducer to a low level (non-critical uses) 15
English Deutsch Español Français Italiano Português Nederlands
aUse either a pre-moistened wipe or a soft cloth dampened with cleaner or disinfectant. Choose a cleaner
from the list of approved cleaners.
bRemove all gel and debris from the transducer.
cWith a new wipe, clean the cable and transducer, starting from the cable, wiping toward the scanhead.
This method helps to avoid cross-contamination.
dObserve the minimum wet contact time recommended by the manufacturer. Monitor the transducer
for wet appearance. Re-apply with a new wipe if no longer wet.
8Verifythat all gel and debris have been removed from the system and transducer. If necessary, repeat
steps 5, 6, & 7 with a new wipe.
Approved cleaners/disinfectants for the transducer:
Product Compatible Transducer Minimum wet contact time1
Sani-Cloth AF32C8x, C11x, C35x, HFL38xi,
HFL50x, HSL25x, ICTx, L25x,
L38xi, P10x, P11x3, rC60xi,
rP19x
3 minutes
Sani-Cloth Plus HFL50x, L52x43 minutes
PI-Spray II C8x, C11x, HFL38xi, HFL50x,
HSL25x, ICTx, L25x, L38xi,
L52x4, P10x, P11x3, rC60xi,
rP19x
10 minutes
1For maximum effectiveness, the component being cleaned must remain wet with disinfectant for a minimum
period of time.
2Qualified for use as an intermediate-level disinfectant for mycobacteria.
3 The P11x Transducer is not licensed for use in Canada.
4 The L52x Transducer is for veterinary use only.
Refer to the cleaners and disinfection document available at www.sonosite.com for a complete list of the most
current cleaners and disinfectants.
Caution Do not allow moisture near the electronic components of the connector.

16 Storing the transducer
9Allow the ultrasound system, including the console and transducer, to air dry in a clean, well-ventilated
space.
10 Examine the system, transducer and cable for damage, such as cracks or splitting where fluid can enter.
If damage is evident, do not use. Instead, contact FUJIFILM SonoSite or your local representative.
Storing the transducer
To store the transducer
1Make sure the transducer has been cleaned and disinfected as detailed in the previous section.
2Store the transducer so that it hangs freely and vertically, and observe the following precautions:
Store the transducer away from any contaminated transducers.
Store the transducer in an environment that is safe and has good airflow. Do not store the transducer
in closed containers or where condensation may occur.
Avoid direct sunlight and exposure to x-rays. Recommended storage temperature range is between
0° C (32° F) and +45° C (113° F).
If using a wall-mounted rack for storage, ensure that:
It is securely mounted.
The storage slots do not mar the transducer or cause damage to the cable.
The rack is sized and positioned to prevent the transducer from inadvertently falling.
Make sure the connector is supported and secure.
Transporting the transducer
When transporting the transducer, you must take precautions to protect the transducer from damage and
avoid cross-contamination. Be sure to use a container approved by your organization.
To transport a soiled transducer for cleaning
A soiled transducer is one that has been contaminated and must be cleaned before using it in an exam.

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Transporting the transducer 17
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1Place the transducer in a clean, approved container.
2Transport the transducer in the container to the point of processing. Do not open the container until the
transducer is ready to be cleaned.
To transport a clean transducer
A clean transducer is one that has completed the cleaning and disinfection process, has been stored
properly, and is ready to be used in an examination.
1Place the transducer in a clean, approved container. To identify the transducer as clean, containers used
to transport clean transducers should carry a cleanliness verification sticker or certificate.
2Transport the transducer in the container to the point of use. Do not open the container until the
transducer is ready to be used.
To ship a transducer
1Place the transducer in the shipping container and seal it. Do not allow any part of the transducer to
protrude from the container.
2Ship the transducer using the following precautions:
Clearly label the container as fragile.
Do not stack items on top of the shipping container.
Do not exceed the shipping temperature range: -35° C (-31° F) to +65° C (149° F).
WARNING To prevent cross-contamination or unprotected exposure of personnel to biological
material, containers used to transport contaminated transducers should carry an
ISO biohazard label similar to the following:
Caution Ensure the transducer is dry before placing it in a closed container. Condensation
from a damp transducer can damage the connector.
Caution Do not leave the transducer in a sealed container for long periods of time.
WARNING Whenever possible, avoid shipping a contaminated transducer. Before shipping,
ensure the transducer has been cleaned and disinfected using the steps detailed in
this chapter or according to special instructions received from FUJIFILM SonoSite. If
you are returning the transducer to FUJIFILM SonoSite, document the disinfection
on a “Declaration of Cleanliness,” and attach it to the packing list.

18 Environmental limits
Do not open the shipping container until it reaches its final destination.
After arrival, the transducer must be cleaned and disinfected before it can be used in an exam.
Specifications
Environmental limits
Mode of Operation:
Continuous 40°C or below.