FujiFilm SonoSite Edge II Betriebsanleitung

User Guide Errata P20025-01

SONOSITE, the SONOSITE logo, SONOSITE EDGE and Steep Needle Profiling are trademarks and registered trademarks of FUJIFILM

Sonosite, Inc. in various jurisdictions. Value from Innovation is a trademark of FUJIFILM Holdings America Corporation.

DICOM is a registered trademark of the National Electrical Manufacturers Association.

All other trademarks are the property of their respective owners.

Patents:

SonoSite Edge II: US 8,956,296; US 8,861,822; US 8,858,436; US 8,834,372; US 8,805,047; US 8,527,033; US 8,500,647; US

8,439,840; US 8,398,408; US 8,355,554; US 8,216,146; US 8,213,467; US 8,147,408; US 8,137,278; US 8,088,071; US 8,066,642;

US 8,052,606; US 7,819,807; US 7,804,970; US 7,740,586; US 7,686,766; US 7,604,596; US 7,591,786; US 7,588,541; US

7,534,211; US 7,449,640; US 7,169,108; US 6,962,566; US 6,648,826; US 6,575,908; US 6,569,101; US 6,471,651; US 6,416,475;

US 6,383,139; US 6,364,839; US 6,203,498; US 6,135,961; US 5,893,363 ; US 5,817,024; US 5,782,769; US 5,722,412; US

8,805,047; US 8,527,033; US 8,858,436; US 8,861,822; US 8,956,296; AU: 730822; AU: 727381; CA 2,372,152; CA: 2,371,711;

CN103237499; CN101231457; CN 98108973.9; CN 98106133.8; CN 97113678.5; DE 69831698.3; DE 69830539.6; DE

69730563.5; DE 602004027882.3; DE 602004023816.3; DE: 60034670.6; DE 60029777.2; EP 1589878; EP 1552792; EP 1180971;

EP 0875203; EP 0815793; EP 1180970; EP 0881492; ES 2229318; ES 159878; ES 1552792; ES 0881492; FR 158978; FR 1552792;

FR 1180970; FR 0881492; FR 0875203; FR 0815793; GB 158978; GB 1552792; GB 1180971; GB 1180970; GB 0881492; GB

0875203; GB 0815793; IT 1589878; IT 1552792; IT 0881492; IT 0815793; JP 5782428; JP 4696150; KR 532359; KR 528102; NO

326814; NO 326202 and pending.

Part number: P20025-01

Publication date: August 2016

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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Introduction 1

Nederlands

SonoSite Edge II User Guide Errata P20025-01

Introduction ..................................................................................................................................................... 1

Document conventions ........................................................................................................................................................................... 1

Getting Help .................................................................................................................................................................................................. 2

Getting Started ............................................................................................................................................... 3

Using AC power and charging the battery ................................................................................................................................... 3

Cleaning and disinfecting .............................................................................................................................. 4

Safety ............................................................................................................................................................... 5

Labeling symbols ........................................................................................................................................................................................ 5

Standards ........................................................................................................................................................................................................ 5

IT Network ....................................................................................................................................................... 6

Functions ......................................................................................................................................................................................................... 6

Network for connecting the device .................................................................................................................................................. 6

Specifications for the connection ....................................................................................................................................................... 6

Introduction

The content in this document was either not included or incorrect in the system user guide; the revisions

will be made in the next update.

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.

For a description of labeling symbols that appear on the product, see "Labeling Symbols" in the ultrasound

system user guide.

2Introduction

Getting Help

For technical support, please contact FUJIFILM SonoSite as follows:

Printed in the U.S.

Phone

(U.S. or Canada)

+1-877-657-8118

Phone

(outside U.S. or

Canada)

+1-425-951-1330, or call your local representative

Fax +1-425-951-6700

Email ffss-service@fujifilm.com

Web www.sonosite.com

Europe Service Center Main: +31 20 751 2020

English support: +44 14 6234 1151

French support: +33 1 8288 0702

German support: +49 69 8088 4030

Italian support: +39 02 9475 3655

Spanish support: +34 91 123 8451

Asia Service Center +65 6380-5581

English Deutsch Español Français Italiano Português

Getting Started 3

Nederlands

Getting Started

Using AC power and charging the battery

To separate the system (and any connected equipment) from a supply mains

Disconnect the AC power cord from the power supply or (alternatively, if using a stand) from the AC

adapter on the stand base.

Cautions The equipment is not provided with an AC mains power switch. To disconnect the

equipment from mains, use the appliance coupler or mains plug on the power

supply cord.

Install the ultrasound system in a place where you can easily connect or

disconnect the AC power cord.

Disconnecting only the DC power cable from the system does not separate the

system from the supply mains.

4Cleaning and disinfecting

Cleaning and disinfecting

Table 1: Approved cleaners

Product Compatible Transducer Minimum wet contact timea

Sani-Cloth AF3bC11x, HFL38xi, HFL50x, HSL25x,

ICTx, L25x, L38xi, P10x, P11x,

rC60xi, rP19x

3 minutes

Sani-Cloth Plus HFL50x, L52x 3 minutes

PI-Spray II C11x, HFL38xi, HFL50x, HSL25x,

ICTx, L25x, L38xi, L52x, P10x,

P11x, rC60xi, rP19x

10 minutes

aFor maximum effectiveness, the component being cleaned must remain wet with disinfectant for a minimum period

of time.

bQualified for use as an intermediate-level disinfectant for mycobacteria.

Refer to the cleaners and disinfection document available at www.sonosite.com for a complete list of the most

current cleaners and disinfectants.

Table 2: High-level compatible disinfectants

Disinfectant Compatible transducers Temperature Disinfectant Soak Duration

Cidex C11x, HFL38xi, HFL50x, HSL25x,

ICTx, L25x, L38xi, P10x, P11x,

rC60xi, rP19x

25oC, 77oF45 minutes

Cidex OPA C11x, HFL38xi, HFL50x, HSL25x,

ICTx, L25x, L38xi, L52x, P10x,

rC60xi, rP19x

20oC, 68oF12 minutes

Refer to the cleaners and disinfection document available at www.sonosite.com for a complete list of the most

current cleaners and disinfectants.

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Safety 5

Nederlands

Safety

Labeling symbols

Standards

Table 3: Labels and symbols

Symbol Definition

Maximum weight load

Table 4: Electromechanical safety standards

Standard Description

ANSI/AAMI ES60601-

1:2005/(R) 2012, and

A1:2012

Medical electrical equipment, Part 1: General requirements for basic safety

and essential performance (Consolidated Edition 3.1)

CAN/CSA C22.2 No.

60601-1:2014 (Edition

3.1)

Medical electrical equipment - Part 1: General Requirements for Basic

Safety and Essential Performance

IEC 60601-1:2012

(Edition 3.1)

Medical electrical equipment - Part 1: General Requirements for Basic

Safety and Essential Performance

IEC 60601-2-37:2007 Medical Electrical Equipment – Part 2-37: Particular requirements for the

basic safety and essential performance of ultrasonic medical diagnostic and

monitoring equipment

IEC 60601-1-6:2010 Medical Electrical Equipment part 1-6: General requirements for basic

safety and essential performance – Collateral Standard: Usability

JIS T0601-1:2013 (3rd

Edition)

Japanese Industrial Standard, General Requirements for Safety of Medical

Electrical Equipment

6ITNetwork

IT Network

Functions

This device can be connected to an IT network to perform the following functions:

Storing the examination data (static images, clips) acquired by this device in a Picture Archiving and

Communication System (PACS) by DICOM communication.

Querying examination orders from the Modality Worklist (MWL) server by DICOM communication and

starting them.

Uploading images to the SonoSite Patient Data Archival Software (PDAS) or SiteLink Image Manager.

Setting the time of this device by interrogating the network time service.

Communicating procedure status via the Modality Performed Procedure Step (MPPS) service.

Requesting transfer of responsibility for image ownership to another system via the Storage Commitment

service.

Network for connecting the device

To ensure safety, use an IT network that is isolated from the external environment by a firewall.

Specifications for the connection

Hardware specification

802.11 b/g/n

Ethernet 100BASE-TX/10BASE-T using RJ45 port with patch cable

Software specifications

This device is connected to PACS and MWL by the DICOM standard. Refer to the DICOM Conformance

Statement of this device for details.

When available, this device connects to the network time server at startup.

The system conforms to the DICOM standard as specified in the SonoSite Edge II, SonoSite SII DICOM

Conformance Statement, available at www.sonosite.com. This statement provides information about the

purpose, characteristics, configuration, and specifications of the network connections supported by the

system.

Security

The port for DICOM communication (specified by the user in the system settings; typically port 104, 2762,

or 11112) is used for outgoing communication to the network.

Anti-virus software is not installed on this device.

English Deutsch Español Français Italiano Português

IT Network 7

Nederlands

This device has a single configurable listening port for the purposes of DICOM Echo and Storage

Commitment.

Data flow

DICOM

MWL Server------------------------> Edge II system-------------------------> PACS

Study order Study data

(DICOM MWL) (DICOM Storage)

Please refer to the SonoSite Edge II, SonoSite SII DICOM Conformance Statement (D18493) for details.

Caution 1 Connection of equipment to an IT network that includes other systems, could

result in previously unidentified risks to patients, operators or third parties. Before

connecting the equipment to an uncontrolled IT Network, make sure that all

potential risks resulting from such connections, were identified and evaluated,

and suitable countermeasures were put in place. IEC 80001-1:2010 provides

guidance for addressing these risks.

2 When a setting of the IT network to which this device is connected has been

changed, check that the change does not affect this device and take measures if

necessary. Changes to the IT network include:

Changes in network configuration (IP address, router etc.)

Connection of additional items

Disconnection of items

Update of equipment

Upgrade of equipment

Any changes to the IT network could introduce new risks requiring additional

evaluation to be performed as per item 1 above.

8ITNetwork

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