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