FujiFilm VisualSonics Vevo MD Manual de usuario

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

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

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

(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

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