FujiFilm SonoSite S Series User manual

Cleaning and Disinfecting
FUJIFILM SonoSite Products
User Guide

2
X-Porte, iViz, Edge, M-Turbo, NanoMaxx, S Series, SonoSite, and the SonoSite logo are registered and unregistered trademarks of FUJIFILM
SonoSite, Inc. in various jurisdictions.
DICOM is a registered trademark of the National Electrical Manufacturers Association.
All other trademarks are the property of their respective owners.
Part Number: P22043-01
Publication Date: October 2015
Copyright © 2015 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 law restricts this device to sale by or on the order of a physician.

iii
CONTENTS
Chapter 1: Introduction
About this guide 1
Conventions 1
Technical support 2
Chapter 2: Cleaning and disinfecting the iViz ultrasound system
Cleaning and disinfecting 4
Cleaning and disinfecting the system and protective case 5
Cleaning and disinfecting the transducer 6
Determining the required cleaning and disinfection level 6
Level A: Intermediate-level disinfection (non-critical) 7
Level B: High-level disinfection (semi-critical) 10
Cleaning and disinfecting the transducer 10
Cleaning the iViz carry case 13
Storing 13
Transporting 13
Disposing of the system 13
Compatible cleaners and disinfectants (system and transducers) 14
Compatible cleaners and disinfectants (accessories) 17
Compatible high-level disinfectants compatible (transducers) 17
Chapter 3: Cleaning and disinfecting the X-Porte ultrasound sys-
tem
Before getting started 20
Cleaning and disinfecting 21
Determining the required cleaning and disinfecting level 21
Spaulding classifications 21
Clean and disinfect system and transducer to a high level (semi-critical uses) 22
Cleaning and disinfecting the system and transducer (semi-critical) 22
Clean and disinfect system and transducer to a low level (non-critical uses) 25
Cleaning and disinfecting the system and transducer (non-critical)26
Storing the transducer 27
Transporting the transducer 28
Compatible cleaners and disinfectants (system and transducers) 30
Compatible cleaners and disinfectants (system accessories) 34
Compatible high-level disinfectants (transducers) 38

iv
CONTENTS
Chapter 4: Cleaning and disinfecting the Edge ultrasound system
Before getting started 43
Cleaning and disinfecting 44
Determining the required cleaning and disinfecting level 44
Spaulding classifications 44
Clean and disinfect system and transducer to a high level (semi-critical uses) 45
Cleaning and disinfecting the system and transducer (semi-critical)45
Clean and disinfect system and transducer to a low level (non-critical uses) 48
Cleaning and disinfecting the system and transducer (non-critical)49
Storing the transducer 50
Transporting the transducer 51
Compatible cleaners and disinfectants (system and transducers) 53
Compatible cleaners and disinfectants (system accessories) 56
Compatible high-level disinfectants (transducers) 61
Chapter 5: Cleaning and disinfecting the SonoSite Edge II ultra-
sound system
Before getting started 64
Cleaning and disinfecting 65
Determining the required cleaning and disinfecting level 65
Spaulding classifications 65
Clean and disinfect system and transducer to a high level (semi-critical uses) 66
Cleaning and disinfecting the system and transducer (semi-critical)66
Clean and disinfect system and transducer to a low level (non-critical uses) 69
Cleaning and disinfecting the system and transducer (non-critical)70
Storing the transducer 71
Transporting the transducer 72
Compatible cleaners and disinfectants (system and transducers) 74
Compatible cleaners and disinfectants (system accessories) 78
Compatible high-level disinfectants (transducers) 81
Chapter 6: Cleaning and disinfecting the S Series ultrasound sys-
tem
Before getting started 85
Cleaning and disinfecting 86

v
CONTENTS
Determining the required cleaning and disinfecting level 86
Spaulding classifications 86
Clean and disinfect system and transducer to a high level (semi-critical uses) 87
Cleaning and disinfecting the system and transducer (semi-critical)87
Clean and disinfect system and transducer to a low level (non-critical uses) 90
Cleaning and disinfecting the system and transducer (non-critical)91
Storing the transducer 92
Transporting the transducer 93
Compatible cleaners and disinfectants (system and transducers) 95
Compatible cleaners and disinfectants (system accessories) 99
Compatible high-level disinfectants (transducers) 103
Chapter 7: Cleaning and disinfecting the M-Turbo ultrasound sys-
tem
Before getting started 106
Cleaning and disinfecting 107
Determining the required cleaning and disinfecting level 107
Spaulding classifications 107
Clean and disinfect system and transducer to a high level (semi-critical uses) 108
Cleaning and disinfecting the system and transducer (semi-critical)108
Clean and disinfect system and transducer to a low level (non-critical uses) 111
Cleaning and disinfecting the system and transducer (non-critical)112
Storing the transducer 113
Transporting the transducer 114
Compatible cleaners and disinfectants (system and transducers) 116
Compatible cleaners and disinfectants (system accessories) 120
Compatible high-level disinfectants (transducers) 124
Chapter 8: Cleaning and disinfecting the NanoMaxx ultrasound
system
Before getting started 126
Cleaning and disinfecting 127
Determining the required cleaning and disinfecting level 127
Spaulding classifications 127
Clean and disinfect system and transducer to a high level (semi-critical uses) 128
Cleaning and disinfecting the system and transducer (semi-critical)128
Clean and disinfect system and transducer to a low level (non-critical uses) 131

vi
CONTENTS
Cleaning and disinfecting the system and transducer (non-critical)132
Storing the transducer 133
Transporting the transducer 134
Compatible cleaners and disinfectants (system and transducers) 136
Compatible cleaners and disinfectants (system accessories) 139
Compatible high-level disinfectants (transducers) 142

About this guide 1
Chapter 1: Introduction
About this guide
This guide contains instructions for cleaning and disinfecting SonoSite systems, transducers, and accessories.
Each system is presented in its own chapter, with cleaning and disinfecting instructions designed specifically
for that system.
If your FUJIFILM SonoSite system is not listed here, refer to the system user guide, or contact FUJIFILM SonoSite
for cleaning instructions.
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 labeling symbols used, see the corresponding ultrasound system user guide.

2Technical support
Technical support
To order sheaths, bite guards, tip covers, and other supplies, see www.civco.com.
For more information or for technical support, contact FUJIFILM SonoSite as follows.
Phone (U.S. or Canada) 877-657-8118
Phone (Outside U.S. or
Canada) 425-951-1330, or call your local representative
Fax [phone]
E-mail [email protected]
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]

3
Chapter 2: Cleaning and disinfecting the iViz ultrasound
system
Cleaning and disinfecting .............................................................................................................................. 4
Cleaning and disinfecting the system and protective case .............................................................................................. 5
Cleaning and disinfecting the transducer .............................................................................................................................. 6
Determining the required cleaning and disinfection level ......................................................................... 6
Level A: Intermediate-level disinfection (non-critical) ....................................................................................................... 7
Level B: High-level disinfection (semi-critical) ..................................................................................................................... 10
Cleaning the iViz carry case ......................................................................................................................... 13
Storing ........................................................................................................................................................... 13
Transporting ................................................................................................................................................. 13
Disposing of the system ............................................................................................................................... 13
Compatible cleaners and disinfectants (system and transducers) ........................................................... 14
Compatible cleaners and disinfectants (accessories) ................................................................................ 17
Compatible high-level disinfectants compatible (transducers) ............................................................... 17
This chapter contains instructions for cleaning and disinfecting the iViz ultrasound system, transducers, and
accessories. Use the FUJIFILM SonoSite recommendations when cleaning and disinfecting your ultrasound
system, transducer, and accessories. Use the cleaning recommendations in the accessory manufacturer’s
instructions when cleaning or disinfecting your accessories.
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.
See www.sonosite.com/transducers for images of transducers.
Also included is a listing of disinfectants that SonoSite has tested and deemed compatible with the iViz
system, transducers, and accessories. This information is presented in the following tables.
Table 2-1,“Cleaning and disinfection guidelines”on page 7 shows compatibility between disinfectants,
the system, and transducers.
Table 2-6, “Cleaners and disinfectants compatible with iViz accessories”on page 17 shows
compatibility between disinfectants and accessories.
Table 2-7, “High-level disinfectants compatible with iViz transducers”on page 17 shows compatibility
between high-level disinfectants and transducers.
Note
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.

4Cleaning and disinfecting
Cleaning and disinfecting
The iViz ultrasound system consists of the system (tablet), accessory case, and transducer.
This section includes instructions for cleaning and disinfecting the iViz ultrasound system. The system must
be cleaned and disinfected after each exam. It is important to follow this cleaning and disinfection process
without shortening or skipping steps. Only use cleaners and disinfectants approved by FUJIFILM SonoSite on
the iViz system. Be sure to observe the solution strength and duration requirements detailed in the cleaning
and disinfection procedures.
Included in this section are instructions for two levels of cleaning and disinfection for both the transducer and
the system. The level of cleaning and disinfection required depends on the type of tissue the system comes
into contact with during an exam. For more information, see “Cleaning and disinfecting the system and
protective case” on page 5.
The materials used in the iViz system are designed and tested to work with the cleaners and disinfectants listed
in this chapter. The iViz system will not be damaged if cleaned according to the approved instructions and with
the approved cleaners and disinfectants. Before using a disinfectant, confirm that it is appropriate for your
facility’s use. Verify expiration dates, concentration, and efficacy of chemicals (for example, a chemical strip
test).
WARNINGS
Ensure that cleaning and disinfecting solutions and wipes are not expired.

Some cleaners and disinfectants can cause an allergic reaction to some individuals.
Transducer
System (tablet)
Accessory case

Cleaning and disinfecting 5
When preparing, using, and disposing of chemicals, be sure to follow manufacturer recommendations and
local regulations.
Cleaning and disinfecting the system and protective case
The following procedures can be used to clean and disinfect the system and protective case.
To clean the system and protective case
1Make sure the system is turned off.
2Disconnect the transducer.
3Remove the system from the protective case.
4Using a soft, damp cloth (dampened with cleaner or disinfectant) or a premoistened disinfectant wipe,
clean any particulate matter or bodily fluids from all system and protective case surfaces.
Be sure to use only cleaners listed in Table 2-2, “Compatible cleaners and disinfectants”on page 7.
Wipe from clean areas to the soiled areas to avoid cross-contamination.
WARNINGS Residual chemicals from some disinfectants can cause an allergic reaction in some
individuals.
Cautions Follow the manufacturer’s cleaning label instructions for solution strengths and
disinfectant contact duration.
Check the expiration date on all cleaning and disinfection solutions and wipes. Do
not use chemicals or wipes that have expired.
Do not allow cleaning solution or disinfectant into the battery compartment,
system controls, 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.
Use only a soft cloth lightly dampened in a mild soap or compatible cleaning
solution to remove any disinfectant on metal surfaces.
Caution Do not immerse the system or the protective case in any liquid.
WARNINGS Wear the appropriate personal protective equipment (PPE), such as eyewear and
gloves, recommended by the chemical manufacturer.

6 Determining the required cleaning and disinfection level
5Verify that all gel, particulate matter, and bodily fluids have been removed.
To disinfect the system and protective case
1Wipe all surfaces with a premoistened wipe or a cloth moistened with a compatible disinfectant listed in
Table 2-2, “Compatible cleaners and disinfectants”on page 7.
Apply the disinfectant solution to the cloth rather than applying it directly to surfaces.
Follow the chemical manufacturer’s requirements for wet contact time.
2Allow the system to air dry following the chemical manufacturer’s requirements for wet contact time.
Cleaning and disinfecting the transducer
Cleaning and disinfecting the transducer requires that you chose the proper cleaning and disinfecting level.
Determining the required cleaning and disinfection level
Before cleaning, visually inspect the ultrasound system to determine that it is 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.
Spaulding classifications are a tool to help reduce cross-contamination and infection by specifying the level
of cleaning and disinfecting required for your medical equipment. The Spaulding classification is based on the
type of device, its usage, and the risk of infection. Based on these criteria, the iViz ultrasound system is
classified as either non-critical or semi-critical, depending on how it is used.
Cautions Do not spray cleaners or disinfectants directly on the system surfaces. Doing so may
cause solution to leak into the system, damaging it and voiding the warranty.
Do not allow moisture to get on the transducer connector or into the connector
ports on the system.
Do not scratch the display screen.
Note Repeat steps 4-5 with new cleaning materials, if necessary.
Caution Use only FUJIFILM SonoSite recommended disinfectants. Using a non-
recommended disinfect solution or incorrect solution strength can damage or
discolor the transducer and void the transducer warranty.

Determining the required cleaning and disinfection level 7
Each Spaulding classification mandates a specific level of cleaning and disinfection of the equipment before
it can be used in the next exam. Use the following guide to determine the level of cleaning and disinfection
for the iViz ultrasound system according to the appropriate Spaulding classification.
Level A: Intermediate-level disinfection (non-critical)
Clean and disinfect the system and protective case immediately after use. Be sure to follow the manufacturer's
instructions when using cleaners and disinfectants. See “Cleaning and disinfecting the system and
protective case” on page 5.
For non-critical disinfection, clean the transducer as described in “To clean the transducer” on page 8, and
then disinfect it as described in “To disinfect the transducer” on page 9.
If the transducer has come into contact with broken skin, mucosal membranes, or blood, you must then do a
high-level disinfection; see “Level B: High-level disinfection (semi-critical)” on page 10.
The materials listed in Table 2-2, “Compatible cleaners and disinfectants”on page 7 are chemically
compatible with the system and transducers. Confirm that the cleaners and disinfectants are appropriate for
your facility’s use.
Table 2-1: Cleaning and disinfection guidelines
If any part of the system came into contact
with... Then disinfect to the following level
Unbroken skin, no blood or bodily fluids (non-
critical)
“Level A: Intermediate-level disinfection (non-
critical)” on page 7
Broken skin, mucosal membranes, blood, and/or
bodily fluids (semi-critical)
“Level B: High-level disinfection (semi-critical)”
on page 10
Table 2-2: Compatible cleaners and disinfectants
Product System Protective
case Carry case P21v transducer
Sani-Cloth AF3 (grey top)
Sani-Cloth Bleach Wipes (yellow top)
Sani-Cloth Plus (red top)
Sani-Cloth HB (green top)
Super Sani-Cloth (purple top)

8 Determining the required cleaning and disinfection level
To clean the transducer
1Clean the transducer cord using either a soft, damp, soapy cloth or a premoistened wipe. Start at the
connector and wipe toward the scan head. Do not get any water or cleaner on the connector.
2Clean all transducer surfaces using either a soft cloth dampened with cleaner or disinfectant or a
premoistened wipe. Be sure to remove any gels or particulate matter.
3Clean the transducer cooling slot using a thin, disposable instrument, such as a swab, to push a soft cloth
lightly dampened with a cleaning solution or a premoistened wipe through the slot.
aPull the cloth back and forth from one side of the slot to the other.
bPull the cloth up and down from the transducer connector to the transducer head.
T-Spray II (PI-Spray II)
Note
Proper cleaning of the slot is important because good airflow through the slot
improves cooling of the transducer electronics and extends the life of the
equipment.
Table 2-2: Compatible cleaners and disinfectants
Product System Protective
case Carry case P21v transducer

Determining the required cleaning and disinfection level 9
cRemove the cloth from the slot.
dDispose of the cloth and the instrument used to insert the cloth.
eVerify that all gel, particulate matter, and bodily fluids have been removed.
To disinfect the transducer
1Disinfect the transducer cord and body by wiping with a cloth moistened with a compatible disinfectant or
premoistened disinfectant wipe. Do not get any disinfectant on the connector.
2Disinfect the cooling slot by using a thin instrument, such as a swab, to push a disinfectant wipe into the slot
.
aPull the wipe back and forth from one side of the slot to the other.
bPull the wipe up and down from the transducer connector to the transducer head.
cRemove the disinfecting wipe from the slot.
dAir dry.
3Examine the transducer and cable for damage, such as cracks or splitting where fluid can enter.
If damage is evident, do not use the transducer and contact FUJIFILM SonoSite or your local representative.
Note Repeat Step 3 with new cleaning materials, if necessary.

10 Determining the required cleaning and disinfection level
Level B: High-level disinfection (semi-critical)
Clean and disinfect the transducer immediately after use.
Be sure to follow the manufacturer's instructions when using cleaners and disinfectants.
Refer to Table 2-3, “Compatible cleaners and disinfectants”on page 10 for a list of cleaners and
disinfectants recommended for use with the transducer.
Cleaning and disinfecting the transducer
Use the following procedures to clean and disinfect the transducer.
To clean the transducer
1Clean the transducer cord using either a cloth dampened with cleaner or disinfectant or a premoistened
disinfectant wipe. Start at the connector and wipe toward the scan head. Do not get any water or cleaner
on the connector.
2Clean all transducer surfaces using either a soft, damp, soapy cloth or disinfectant wipe. Be sure to remove
any gels or particulate matter.
Table 2-3: Compatible cleaners and disinfectants
Product P21v transducer
Sani-Cloth AF3 (grey top)
Sani-Cloth Bleach Wipes (yellow top)
Sani-Cloth Plus (red top)
Sani-Cloth HB (green top)
T-Spray II (PI-Spray II)

Determining the required cleaning and disinfection level 11
3Clean the transducer cooling slot using a thin, disposable instrument, such as a swab, to push a soft cloth
lightly dampened with a cleaning solution or premoistened wipe through the slot.
aPull the cloth back and forth from one side of the slot to the other.
bPull the cloth up and down from the transducer connector to the transducer head.
cRemove the cloth from the slot.
dDispose of the cloth and the instrument used to insert the cloth.
eVerify that all gel, particulate matter, and bodily fluids have been removed.
To high-level disinfect the transducer
1Mix the disinfectant solution following disinfectant label instructions for solution strengths and disinfectant
contact duration.
Be sure to use a compatible disinfectant as listed in Table 2-7,“High-level disinfectants compatible with
iViz transducers”on page 17.
Note Repeat Step 3 with new cleaning materials, if necessary.
Caution Use only FUJIFILM SonoSite recommended disinfectants. Using a non-
recommended disinfection solution, incorrect solution strength, or immersing a
transducer deeper or for a longer period of time than recommended can damage or
discolor the transducer and void the transducer warranty.

12 Determining the required cleaning and disinfection level
2Immerse the transducer and about two inches of the cable in the disinfectant solution.
Use this diagram as a reference and then follow the instructions on the disinfectant label for the duration of
the transducer immersion.
3Using the instructions on the disinfectant label, rinse to the point of the previous immersion, and then air
dry or towel dry with a clean, non-linting cloth.
4Examine the transducer and cord 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
Cleaning and disinfecting the transducer requires that you chose the proper cleaning and disinfecting level.
Caution Do not immerse the transducer connector in any liquid.
Table 2-4: Approved high-level disinfectants and soak times
Disinfectant Temperature Duration
Cidex 25° C (77° F) 45 minutes
Cidex OPA 20° C (68° F) 12 minutes

Cleaning the iViz carry case 13
Cleaning the iViz carry case
To clean the iViz carry case, use mild soap and water, and wash it by hand or machine. You can also use one of
the cleaners listed in Table 2-2, “Compatible cleaners and disinfectants”on page 7 to clean it.
Using other chemicals may cause discoloration.
Storing
Clean and disinfect the iViz ultrasound system prior to storing it.
Store the system in a clean place with good airflow. Disconnect the transducer from the system, and hang it
vertically.
Transporting
When transporting the iViz ultrasound system, you must take precautions to protect the equipment from
damage and avoid cross-contamination.
Clean and disinfect the system by following the instructions in “Cleaning and disinfecting the system and
protective case” on page 5.
Be sure to transport the system in a container approved by your facility.
Disposing of the system
If the iViz ultrasound system shows damage or deterioration, such as corrosion, discoloration, pitting, or
cracking, do not dispose of it. Contact FUJIFILM SonoSite or your local representative.
WARNINGS
The battery inside this unit may explode if exposed to very high temperatures. Do
not destroy this unit by incinerating or burning. Return the unit to FUJIFILM
SonoSite or your local representative for disposal.

14 Compatible cleaners and disinfectants (system and transducers)
Compatible cleaners and disinfectants (system and
transducers)
Table 2-5: Cleaners and disinfectants compatible with the iViz system and transducers
Disinfectants
iViz system Protective case P21v
Airkem A-33
Alcohol-Ethanol
Aniosyme DD1- 5%
Anioxide 1000
Asepti Wipe II
Baxedin Pre-Op
Caviwipes
Cidalkan
Cidalkan Lingettes
Clinell Universal Sanitising
Wipes
Control III
Coverage Germicidal Surface
Wipes
Coverage Plus Germicidal
Surface Wipes
Coverage Spray TB
DisCide Ultra Disinfecting
Towlettes