FujiFilm SonoSite Edge II Bedienungsanleitung

SonoSite Edge II

Ultrasound System User Guide

USER GUIDE

SiteLink, SonoSite Edge, SonoHD2, SonoMB, Steep Needle Profiling, SonoSite, and the SonoSite logo 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: US 9,151,832; 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; 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: P20516-04

Publication Date: May 2017

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 Federal (United States) law restricts this device to sale by or on the order of a

physician.

iii

CONTENTS

1. Introduction

Changes in version 1.2 ....................................................................................................................................... 1-1

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

Getting help .............................................................................................................................................................. 1-2

2. Getting Started

About the system .................................................................................................................................................. 2-1

License key ............................................................................................................................................................... 2-1

Intended uses ......................................................................................................................................................... 2-1

Hardware features ................................................................................................................................................. 2-4

Preparing the system .......................................................................................................................................... 2-5

Installing or removing the battery ....................................................................................................... 2-5

Using AC power and charging the battery .................................................................................... 2-7

Turning the system on or off ................................................................................................................. 2-8

Connecting transducers ............................................................................................................................ 2-9

Inserting and removing USB storage devices ............................................................................2-10

System controls ...................................................................................................................................................2-12

Screen layout .........................................................................................................................................................2-14

General interaction ..............................................................................................................................................2-15

Touchpad and cursor ..............................................................................................................................2-15

On-screen controls ....................................................................................................................................2-16

Annotation and text ................................................................................................................................2-17

Preparing the transducers ...............................................................................................................................2-19

3. System Setup

Displaying the setup pages .............................................................................................................................. 3-1

Restoring default settings ................................................................................................................................. 3-1

A & B Key, Footswitch setup ........................................................................................................................... 3-1

Administration setup ............................................................................................................................................ 3-2

Security settings ........................................................................................................................................... 3-2

User setup ....................................................................................................................................................... 3-4

Exporting or importing user accounts ............................................................................................... 3-5

Exporting and clearing the Event log ................................................................................................ 3-5

Logging in as user ....................................................................................................................................... 3-6

Choosing a secure password ................................................................................................................. 3-6

Annotations setup ................................................................................................................................................. 3-7

Audio, Battery setup ............................................................................................................................................ 3-8

Cardiac Calculations setup ............................................................................................................................... 3-9

Connectivity setup ................................................................................................................................................ 3-9

Date and Time setup ......................................................................................................................................... 3-10

Display Information setup .............................................................................................................................. 3-10

Network Status setup ....................................................................................................................................... 3-11

OB Calculations setup ...................................................................................................................................... 3-11

OB Custom Measurements setup .............................................................................................................. 3-12

OB Custom Tables setup ................................................................................................................................. 3-12

Presets setup ........................................................................................................................................................ 3-14

System Information setup .............................................................................................................................. 3-15

USB Devices setup ............................................................................................................................................ 3-16

Limitations of JPEG format ................................................................................................................... 3-17

4. Imaging

Imaging modes ....................................................................................................................................................... 4-1

2D imaging ...................................................................................................................................................... 4-1

M Mode imaging .......................................................................................................................................... 4-4

CPD and Color imaging ............................................................................................................................. 4-4

PW and CW Doppler imaging ............................................................................................................... 4-6

Adjusting depth and gain .................................................................................................................................. 4-9

Freezing, viewing frames, and zooming ................................................................................................. 4-10

Visualizing needles ............................................................................................................................................. 4-11

About Steep Needle Profiling technology ................................................................................... 4-11

Needle size and angle ............................................................................................................................ 4-13

Additional recommendations .............................................................................................................. 4-14

Centerline ................................................................................................................................................................ 4-14

Imaging modes and exams available by transducer ........................................................................ 4-15

Annotating images ............................................................................................................................................. 4-23

Patient information form .................................................................................................................................. 4-25

Patient information form fields ........................................................................................................... 4-27

Images and clips .................................................................................................................................................. 4-28

Saving images and clips ........................................................................................................................ 4-28

Reviewing patient exams ..................................................................................................................... 4-30

Printing, exporting, and deleting images and clips ................................................................. 4-32

ECG ............................................................................................................................................................................ 4-34

ECG controls ................................................................................................................................................ 4-35

5. Measurements and Calculations

Measurements ......................................................................................................................................................... 5-1

Working with calipers ................................................................................................................................ 5-1

Saving measurements ............................................................................................................................... 5-2

2D measurements ....................................................................................................................................... 5-3

M Mode measurements ........................................................................................................................... 5-4

Doppler measurements ............................................................................................................................ 5-5

General Calculations ............................................................................................................................................. 5-7

Calculations menu ........................................................................................................................................ 5-7

Performing and saving measurements in calculations ............................................................. 5-8

Displaying, repeating, and deleting saved measurements ................................................... 5-8

EMED calculations ....................................................................................................................................... 5-9

Percent reduction calculations ............................................................................................................... 5-9

Volume calculation .................................................................................................................................... 5-11

Volume flow calculation ......................................................................................................................... 5-11

Exam-based calculations ................................................................................................................................ 5-13

Arterial calculations .................................................................................................................................. 5-13

Cardiac calculations .................................................................................................................................. 5-15

Gynecology (Gyn) calculations .......................................................................................................... 5-29

OB calculations ........................................................................................................................................... 5-30

Small Parts and MSK calculations ..................................................................................................... 5-35

Transcranial Doppler and Orbital calculations ............................................................................ 5-36

Patient reports and worksheets .................................................................................................................. 5-38

Arterial and cardiac patient reports ................................................................................................. 5-39

OB patient report ...................................................................................................................................... 5-39

TCD patient report .................................................................................................................................... 5-40

EMED and MSK worksheets ............................................................................................................... 5-40

6. Measurement references

Measurement accuracy ...................................................................................................................................... 6-1

Sources of measurement errors ........................................................................................................... 6-3

Measurement publications and terminology ........................................................................................... 6-4

Cardiac references ....................................................................................................................................... 6-4

Obstetrical references ............................................................................................................................. 6-14

General references ................................................................................................................................... 6-20

7. Troubleshooting and Maintenance

Troubleshooting ...................................................................................................................................................... 7-1

Software licensing ................................................................................................................................................. 7-3

Maintenance ............................................................................................................................................................. 7-4

Cleaning and disinfecting ......................................................................................................................... 7-4

8. Cleaning and Disinfecting

Before getting started ......................................................................................................................................... 8-1

Determining the required cleaning and disinfecting level ................................................................ 8-2

Spaulding classifications ........................................................................................................................... 8-3

Clean and disinfect system and transducer to a high level (semi-critical uses) ................... 8-3

......................Clean and disinfect system and transducer to a low level (non-critical uses) 8-8

Storing the transducer ..................................................................................................................................... 8-11

Transporting the transducer .......................................................................................................................... 8-11

Cleaning the stand ............................................................................................................................................. 8-13

Cleaning accessories ......................................................................................................................................... 8-13

Cleaning and disinfecting the ECG cable and slave cable ................................................... 8-13

9. Safety

Ergonomic safety ................................................................................................................................................... 9-1

Position the system .................................................................................................................................... 9-2

Position yourself ........................................................................................................................................... 9-2

Take breaks, exercise, and vary activities ....................................................................................... 9-3

Electrical safety ....................................................................................................................................................... 9-4

Electrical safety classification ................................................................................................................. 9-7

Equipment safety ................................................................................................................................................... 9-8

Battery safety .......................................................................................................................................................... 9-9

Clinical safety ........................................................................................................................................................ 9-10

Hazardous materials .......................................................................................................................................... 9-11

Electromagnetic compatibility ...................................................................................................................... 9-11

Wireless transmission ............................................................................................................................. 9-12

Electrostatic discharge ............................................................................................................................ 9-13

Separation distance .................................................................................................................................. 9-14

Compatible accessories and peripherals ....................................................................................... 9-14

Manufacturer’s declaration ................................................................................................................... 9-17

Labeling symbols ................................................................................................................................................ 9-20

Specifications ........................................................................................................................................................ 9-24

Dimensions ................................................................................................................................................... 9-24

Environmental limits ................................................................................................................................ 9-25

Electrical specifications ........................................................................................................................... 9-25

Battery specifications .............................................................................................................................. 9-25

Standards ................................................................................................................................................................ 9-26

Electromechanical safety standards ................................................................................................ 9-26

EMC standards classification ............................................................................................................... 9-26

Biocompatibility standards ................................................................................................................... 9-27

Airborne equipment standards .......................................................................................................... 9-27

DICOM standard ........................................................................................................................................ 9-27

HIPAA standard .......................................................................................................................................... 9-27

10. Acoustic Output

ALARA principle .................................................................................................................................................. 10-1

Applying the ALARA principle ........................................................................................................... 10-1

Direct controls ............................................................................................................................................. 10-2

Indirect controls .......................................................................................................................................... 10-2

Receiver controls ....................................................................................................................................... 10-3

Acoustic artifacts ................................................................................................................................................. 10-3

vii

Guidelines for reducing MI and TI .............................................................................................................. 10-3

Output display ...................................................................................................................................................... 10-7

MI and TI output display accuracy ................................................................................................... 10-9

Factors that contribute to display uncertainty ........................................................................... 10-9

Related guidance documents ............................................................................................................. 10-9

Transducer surface temperature rise ..................................................................................................... 10-10

Acoustic output measurement ................................................................................................................. 10-11

In Situ, derated, and water value intensities ........................................................................... 10-11

Tissue models and equipment survey ........................................................................................ 10-12

Acoustic output tables .................................................................................................................................. 10-13

Terms used in the acoustic output tables ................................................................................. 10-68

Acoustic measurement precision and uncertainty ............................................................... 10-70

11. IT Network

Functions ................................................................................................................................................................. 11-1

Network for connecting the device ........................................................................................................... 11-1

Specifications for the connection ............................................................................................................... 11-1

Glossary

Terms ............................................................................................................................................................................A-1

Abbreviations ...........................................................................................................................................................A-2

Index .....................................................................................................................................B-1

viii

Introduction 1-1

CHAPTER 1

Introduction

This SonoSite Edge II Ultrasound System User Guide provides information on preparing

and using the SonoSite Edge II ultrasound system and on cleaning and disinfecting the

system and transducers. It also provides system specifications, and safety and acoustic

output information.

The user guide is for a reader familiar with ultrasound techniques. It does not provide

training in sonography or clinical practices. Before using the system, you must have

ultrasound training.

Refer to the applicable FUJIFILM SonoSite accessory user guide for information on using

accessories and peripherals. Refer to the manufacturer’s instructions for specific

information about peripherals.

Changes in version 1.2

Document conventions

The user guide 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.

Single-step procedures begin with .

Features Description

rP19x needle guide; HFL38xi

and L25x armored transducers;

lowered MI setting; new USB

export option

Needle guide enabled for the rP19x transducer.

HFL38xi and L25x armored transducers now

available. MI setting lowered for LVO On control.

Option to disable USB export.

1-2 Introduction

Symbols and terms used on the system and transducer are explained in “Labeling symbols” on page 9-20

and the “Glossary” on page A-1.

Getting help

In addition to this user guide, the following resources are available:

Instructional videos available on-line.

FUJIFILM SonoSite Technical Support:

Phone

(U.S. or Canada)

877-657-8118

Phone

(outside U.S. or Canada)

425-951-1330, or call your local representative

Fax 425-951-6700

Email [email protected]

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

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