FujiFilm VisualSonics Vevo MD User manual

Legal Notices
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
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.
SonoSite, VisualSonics, Vevo, Vevo MD and the VisualSonics logo are registered and unregistered
trademarks of FUJIFILM SonoSite, Inc. in various jurisdictions. All other trademarks are the property of
their respective owners.
Patents: CA 2501647; CA 2525220; CN 201430080125.0; CN ZL200380101220.3; CN ZL200380105066.7; CN ZL20040013162.3; CN
ZL200480019107.5; CN ZL200580020418.8; CN ZL200680014137.6; CN 200680018668; CN 200680050246; CN ZL200780016016.X; CN
ZL200780027688.0; EU 1853169; FR 1465531; FR 1625630;FR 1642154; FR 1715897; FR 1738407; FR 1853169; FR 1952175; FR 2029025; DE
1465531; DE 1738407; DE 1853169; DE 1952175; DE 2029025; DE 602004007521; DE 602004010098; DE 602005021057; HK 1085109; HK
1087316; HK 1129243; HK 1132644; IE 1465531; IT 1465531; IT 1715897; IT 1738407; IT 1952175; JP 4713339; JP 4331720; JP 4805140; JP
4805254; JP 4807761; JP 4869932; JP 4942666; JP 5254867; JP 5415086; JP 2014-7668; JP 2014-7669; JP 2014-7671; NL 1465531; NL 1715897;
NL 1738407; ES 1465531; ES 1952175; GB 1465531; GB 1625630; GB 1642154; GB 1715897; GB 1738407; GB 1952175; GB 2029025; US
6,851,392; US 6,984,284; US 7,052,460; US 7,133,713; US 7,230,368; US 7,255,678; US 7,426,904; US 7,434,542; US 7,674,228; US 7,750,536; US
7,798,963; US 7,808,156; US 7,830,069; US 7,901,358; US 8,078,256; US 8,275,449; US 8,316,518; US 8,317,714; US 8,343,289; US 8,529,452; US
8,708,909; US 8,827,907; US 8,847,467; US 8,945,014 and pending.
Part Number: 52722 1.0
Publication Date: December 21, 2015
Copyright © 2015 FUJIFILM SonoSite, Inc. All rights reserved.
3

Contents
Cleaning and Disinfecting - English 7
Nettoyage et désinfection - Français 31
Reinigung und Desinfektion – Deutsch 57
Pulizia e disinfezione - Italiano 85
Limpieza y desinfección - Español 109
5

Cleaning and Disinfecting - English
This guide includes the following sections:
lCleaning and disinfecting on the next page
lStepA: Semi-critical contact cleaning and disinfecting of system and
transducer on page 11
lStep B: Non-critical contact cleaning and disinfecting of the system and
transducer on page 18
lCleaning and disinfecting the foot switch on page 23
Cleaning and Disinfecting - English 7

Cleaning and disinfecting
The system and transducer must be cleaned and disinfected after each exam. It is
important to follow these cleaning and disinfecting instructions without skipping any
steps.
System Transducer
Determining the required cleaning and disinfecting level
Note: Please be aware that you must perform both a cleaning as well as a
disinfection for each component.
The level of cleaning and disinfecting required for the system and transducer is
dictated by the type of tissue it contacts during use. Use the Cleaning and disinfecting
guide on the facing page 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 transducer are designed for use within
the Spaulding classifications of non-critical and semi-critical, as per the Cleaning and
disinfecting guide on the facing page.
8 Cleaning and Disinfecting - English

Did any part of the system or transducer come in contact with
broken skin, blood, or bodily fluids?
YES
(semi-critical) ►
StepA: Semi-critical contact
cleaning and disinfecting of
system and transducer on
page 11
OR
NO
(non-critical) ►
Step B: Non-critical contact
cleaning and disinfecting of
the system and transducer on
page 18
Cleaning and disinfecting guide
Before getting started
lInspect the system and transducer 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.
lConfirm that cleaning and disinfecting materials are appropriate for your
facility’s use. FUJIFILM SonoSite tests disinfectants and disinfectant devices
for use with the system and transducer.
lVerify expiration dates, concentration, and efficacy of chemicals (for example,
a chemical strip test). Disinfectants and cleaning methods listed are
recommended by FUJIFILM SonoSite for efficacy and material compatibility
with the products.
lEnsure that the disinfectant type and the solution strength and duration are
appropriate for the equipment.
Cleaning and Disinfecting - English 9

lFollow manufacturer recommendations and local regulations, when preparing,
using, and disposing of chemicals.
lFollow the disinfectant manufacturer’s recommendations regarding appropriate
personal protective equipment (PPE), such as protective eye wear and gloves.
WARNING: 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 or
transducer connectors.
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.
10 Cleaning and Disinfecting - English

StepA: Semi-critical contact cleaning and disinfecting of
system and transducer
Part 1 of 2: Cleaning of system and transducer, disinfecting of system for
semi-critical contact
Follow the manufacturer's instructions when using cleaners and disinfectants. The
materials listed in the table below are chemically compatible with the system and
transducer. Confirm that cleaning and disinfecting materials are appropriate for your
facility’s use.
Product System Transducers
(UHF22, UHF48, UHF70) Wet Contact Time
Tristel Sporicidal Wipes 30 seconds
Microbac Tissues 1 minutes
Cleanisept wipes 2 minutes
Sani-Cloth AF3
(grey top)*3 minutes
Sani-Cloth Bleach
(orange top)*4 minutes
Sani-Cloth HB
(green top) 10 minutes
Compatible cleaners and disinfectants
Cleaning and Disinfecting - English 11

Product System Transducers
(UHF22, UHF48, UHF70) Wet Contact Time
PI-Spray II 10 minutes
*Qualified for use as an intermediate-level disinfectant for mycobacteria
Compatible cleaners and disinfectants
WARNING: Disconnect the system from the power before cleaning to avoid
electrical shock.
Wear the appropriate personal protective equipment (PPE) recommended by
the chemical manufacturer, such as eyewear and gloves.
Caution: Do not spray cleaners and disinfectants directly on surfaces or on the
connectors of the system and transducer—doing so may cause solutions to leak
into the system, damaging it and voiding the warranty.
Do not scratch the clinical display.
Do not attempt to disinfect a transducer using a method or chemical that is not
included here. This can damage the transducer and void the warranty.
Use only FUJIFILM SonoSite recommended disinfectants. Using a non-
recommended disinfecting solution or incorrect solution strength can damage the
system and void the warranty. Follow the disinfectant manufacturer’s
recommendations.
12 Cleaning and Disinfecting - English

START
Semi-critical cleaning and disinfection
1 Put on gloves, for protection from cleaning and disinfecting materials. Change
gloves as needed throughout the procedure.
2 Turn off the system by pressing the Power button.
3 Turn off the main power switch located on the bottom of the system near the back,
where the power cord connects.
4 Unplug the power cord from the outlet.
5 Unplug the network cable, if applicable.
6 Disconnect and remove the transducer from the system.
7 Remove the transducer sheath (probe cover), if applicable.
8 Obtain a compatible cleaner. Compatible cleaning materials are listed in the table
Compatible cleaners and disinfectants on page 11.
Caution: Make sure the solution does not get into any of the connector ports.
Apply the disinfectant solution to the cloth rather than applying it directly to
surfaces if not using a wipe.
9 Clean the transducer cable and transducer body to remove any visible gel, debris,
or bodily fluids.
♦ Starting from the transducer connector end, clean the transducer cable and
transducer body in a downward motion toward the scanhead. Wipe from clean areas
to the soiled areas to avoid cross-contamination.
Caution: Do not wipe the transducer connector.
Cleaning and Disinfecting - English 13

10 Clean the system to remove any visible gel, debris or bodily fluids.
♦Wipe from clean areas to the soiled areas to avoid cross-contamination.
11 Verify that all gel, debris, and bodily fluids have been removed from the transducer
and system. If necessary, repeat Steps 9 and 10, with a new wipe.
12 Obtain a compatible disinfectant. Compatible disinfectant materials listed in the
table Compatible cleaners and disinfectants on page 11.
Caution: Make sure the solution does not get into any of the connector ports.
Apply the disinfectant solution to the cloth rather than applying it directly to
surfaces if not using a wipe.
13 Disinfect the system by wiping all surfaces including:
lclinical display (upper monitor)
lcontrol panel (lower monitor)
ltransducer and gel holders
lcable hooks
lgrab bars
lall surfaces that may have been touched and/or contaminated
14 Ensure the system stays wet with the disinfectant for the wet contact time listed
in the table Compatible cleaners and disinfectants on page 11. This may require
reapplication to achieve the required wet time.
♦ For example, if you are using Sani-Cloth Bleach it has a wet contact time of 4
minutes. Wipe the entire system until thoroughly wet. If the system starts to dry
before the 4 minutes is reached, use a new wipe and re-wet the system. Continue the
process of re-wetting with a new wipe until a total wet time of 4 minutes is reached.
15 Allow the system to air dry in a clean, well ventilated space. Do not dry with a
cloth.
14 Cleaning and Disinfecting - English

16 Continue to Part 2 of 2: High-level disinfecting of transducer for semi-critical
contact below.
Part 2 of 2: High-level disinfecting of transducer for semi-critical contact
WARNING: Wear the appropriate personal protective equipment (PPE)
recommended by the chemical manufacturer, such as eyewear and gloves.
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.
Caution: Do not skip any steps or abbreviate the disinfecting process in any way.
Do not use unapproved disinfecting agents.
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 disinfectants. Using a non-
recommended disinfecting solution or incorrect solution strength can damage or
discolor the transducer and void the transducer warranty.
Cleaning and Disinfecting - English 15

Transducer Disinfectant Temperature Disinfectant
soak duration
Clean water
soak time
UHF22
UHF48
UHF70
Cidex 25°C (77°F) 45 minutes 3 x 1 minute
Compatible high-level disinfectants for semi-critical contact
1 Ensure you have cleaned the transducer as seen in Part 1 of 2: Cleaning of system
and transducer, disinfecting of system for semi-critical contact on page 11.
2 Obtain compatible high-level disinfecting materials. Compatible materials listed in
the table Compatible high-level disinfectants for semi-critical contact above.
Caution: Ensure that you select the proper disinfectant according to your
transducer.
Cidex OPA is not compatible with any FUJIFILM SonoSite UHFtransducer.
Use only FUJIFILM SonoSite recommended disinfectants listed in the table
Compatible high-level disinfectants for semi-critical contact above to avoid damage
to the transducer.
3 Follow the information in the table Compatible high-level disinfectants for semi-
critical contact above for solution strengths and soak times. Refer to the disinfectant
manufacturer’s instructions for additional information.
4 Immerse the transducer into the high-level disinfectant solution. Refer to the table
Compatible high-level disinfectants for semi-critical contact above for soak times.
Ensure that the transducer connector remains out of the fluid. Ensure that the
scanhead and only 2 in (5 cm) are immersed. Refer to the figure below.
16 Cleaning and Disinfecting - English

Cannot be immersed Can be immersed
Connector Cable Scanhead
5 Rinse by soaking the area that was immersed, in sterile or clean water, according
to the disinfectant manufacturer’s instructions. See the table Compatible high-level
disinfectants for semi-critical contact on the previous page for a list of clean water
soak times.
♦ For example, Cidex OPA recommends a minimum 1 minute soak repeated 3 times.
This requires either replacing the water three times or having 3 bins with fresh water.
6 Dry with a clean lint-free cloth, or allow to air dry completely.
7 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.
DONE
Cleaning and Disinfecting - English 17

Step B: Non-critical contact cleaning and disinfecting of
the system and transducer
Follow the manufacturer's instructions when using cleaners and disinfectants. The
materials listed in the table below are chemically compatible with the system and
transducer. Confirm that cleaning and disinfecting materials are appropriate for your
facility’s use.
Product System Transducers
(UHF22, UHF48, UHF70) Wet Contact Time
Tristel Sporicidal Wipes 30 seconds
Microbac Tissues 1 minutes
Cleanisept wipes 2 minutes
Sani-Cloth AF3 (grey
top)*3 minutes
Sani-Cloth Bleach
(orange top)*4 minutes
Sani-Cloth HB
(green top) 10 minutes
PI-Spray II 10 minutes
*Qualified for use as an intermediate-level disinfectant for mycobacteria
Compatible cleaners and disinfectants
18 Cleaning and Disinfecting - English

WARNING: Disconnect the system from the power before cleaning to avoid
electrical shock.
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 surfaces or on the
connectors of the system and transducer—doing so may cause solutions to leak
into the system, damaging it and voiding the warranty.
Do not scratch the clinical display.
Do not attempt to disinfect a transducer using a method or chemical that is not
included here. This can damage the transducer and void the warranty.
Use only FUJIFILM SonoSite recommended disinfectants. Using a non-
recommended disinfecting solution or incorrect solution strength can damage the
system and void the warranty. Follow the disinfectant manufacturer’s
recommendations.
Cleaning and Disinfecting - English 19

START
Non-critical cleaning and disinfecting
1 Put on gloves, for protection from cleaning and disinfecting materials. Change
gloves as needed throughout the procedure.
2 Turn off the system by pressing the Power button.
3 Turn off the main power switch located on the bottom of the system near the back,
where the power cord connects.
4 Unplug the power cord from the outlet.
5 Unplug the network cable, if applicable.
6 Disconnect and remove the transducer from the system.
7 Remove the transducer sheath (probe cover), if applicable.
8 Obtain a compatible cleaner. Compatible cleaning materials are listed in the table
Compatible cleaners and disinfectants on page 18.
Caution: Make sure that the solution does not get into any of the connector ports.
Apply the disinfectant solution to the cloth rather than applying it directly to
surfaces, if not using a wipe.
9 Clean the transducer cable and transducer body to remove any visible gel, debris or
bodily fluids.
♦ Starting from the transducer connector end, clean the transducer cable and
transducer body in a downward motion toward the scanhead. Wipe from clean areas
to the soiled areas to avoid cross-contamination.
Caution: Do not wipe the transducer connector.
20 Cleaning and Disinfecting - English