FujiFilm SonoSite Edge II Bedienungsanleitung

SonoSite Edge II

Ultrasound System User Guide

USER GUIDE

SiteLink, Edge, SonoCalc, SonoHD2, SonoMB, Steep Needle Profiling, SonoSite, and the SonoSite logo are registered and unregistered

trademarks of FUJIFILM SonoSite, Inc. in various jurisdictions.

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

All other trademarks are the property of their respective owners.

Patents: US 8,956,296; US 8,861,822; US 8,858,436; US 8,834,372; 8,805,047; US 8,527,033; 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; US8,052,606; US 7,819,807; US 7,804,970; US 7,740,586;

US 7,686,766; US 7,604,596; US7,591,786; 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; US6,569,101; 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; US5,817,024;

US 5,782,769; US 5,722,412; AU: 730822; AU: 727381; CA 2,372,152; CA: 2,371,711; CN 98108973.9; CN98106133.8; CN 97113678.5; DE

69831698.3; DE 69830539.6; DE 69730563.5; DE 602004027882.3; DE602004023816.3; 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; FR0881492; 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 4696150; KR 532359; KR 528102; NO 326814; NO 326202 and pending.

Part Number: P20516-02

Publication Date: March 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 law restricts this device to sale by or on the order of a physician.

Contents

Chapter 1: Introduction

About the SonoSite Edge II User Guide .................................................................1

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

Getting help .....................................................................................................................2

Chapter 2: Getting Started

About the system ...........................................................................................................3

Intended use ...................................................................................................................3

Hardware features .........................................................................................................6

Preparing the system ....................................................................................................7

Installing or removing the battery .................................................................7

Using AC power and charging the battery ..................................................9

Turning the system on or off ..........................................................................10

Connecting transducers ...................................................................................10

Inserting and removing USB storage devices ..........................................12

System controls ............................................................................................................13

Screen layout .................................................................................................................15

General interaction .....................................................................................................16

Touchpad and cursor .......................................................................................16

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

Annotation and text ..........................................................................................17

Preparing the transducers ........................................................................................19

Chapter 3: System Setup

Displaying the setup pages ......................................................................................21

Restoring default settings ........................................................................................21

A & B Key, Footswitch setup .....................................................................................21

Administration setup ..................................................................................................22

Security settings ..................................................................................................22

User setup .............................................................................................................23

Exporting or importing user accounts ........................................................24

Exporting and clearing the Event log .........................................................25

Logging in as user ..............................................................................................26

Choosing a secure password ..........................................................................26

Annotations setup .......................................................................................................26

Audio, Battery setup ...................................................................................................28

Cardiac Calculations setup ......................................................................................28

Connectivity setup ......................................................................................................28

Date and Time setup ...................................................................................................29

Display Information setup ........................................................................................29

Network Status setup .................................................................................................30

OB Calculations setup ................................................................................................30

OB Custom Measurements setup ..........................................................................31

OB Custom Tables setup ...........................................................................................31

Presets setup .................................................................................................................33

System Information setup ........................................................................................34

USB Devices setup .......................................................................................................34

Limitations of JPEG format ..............................................................................35

eFilm Lite image-viewer ...................................................................................36

Chapter 4: Imaging

Imaging modes ............................................................................................................37

2D imaging ...........................................................................................................37

M Mode imaging ................................................................................................39

CPD and color Doppler imaging ...................................................................40

PW and CW Doppler imaging ........................................................................41

Adjusting depth and gain .........................................................................................44

Freezing, viewing frames, and zooming .............................................................45

Needle visualization ...................................................................................................46

About Steep Needle Profiling technology ................................................46

Needle size and angle .......................................................................................48

Additional recommendations ........................................................................49

Centerline .......................................................................................................................49

Imaging modes and exams available by transducer ......................................50

Annotating images .....................................................................................................55

Patient information form ..........................................................................................57

Images and clips ..........................................................................................................60

Saving images and clips ...................................................................................60

Reviewing patient exams ...............................................................................61

Printing, exporting, and deleting images and clips ...............................63

ECG Monitoring ............................................................................................................65

Chapter 5: Measurements and Calculations

Measurements ..............................................................................................................67

Working with calipers .......................................................................................67

2D measurements ..............................................................................................68

M Mode measurements ...................................................................................70

Doppler measurements ...................................................................................70

General calculations ...................................................................................................73

Calculations menu .............................................................................................73

Performing and saving measurements .....................................................74

Displaying, repeating, and deleting saved measurements ................74

EMED calculations ..............................................................................................75

Percent reduction calculations ......................................................................75

Volume calculations ..........................................................................................76

Volume flow calculations .................................................................................77

Exam-based calculations ..........................................................................................79

Cardiac calculations ...........................................................................................79

Gynecology (Gyn) calculations ......................................................................95

OB calculations ....................................................................................................96

iii

Small Parts and MSK calculations ..............................................................100

Transcranial Doppler and Orbital calculations ......................................101

Vascular calculations ...................................................................................... 104

Patient report .............................................................................................................106

Vascular and cardiac patient reports ........................................................ 106

TCD patient report .......................................................................................... 107

OB patient report .............................................................................................107

EMED and MSK worksheets ......................................................................... 108

Chapter 6: Measurement References

Measurement accuracy ..........................................................................................111

Sources of measurement errors ..........................................................................112

Measurement publications and terminology ................................................. 113

Cardiac references ...........................................................................................113

Obstetrical references ....................................................................................123

Gestational age tables ...................................................................................125

Growth analysis tables ...................................................................................127

Ratio calculations .............................................................................................129

General references ..........................................................................................129

Chapter 7: Troubleshooting and Maintenance

Troubleshooting ........................................................................................................133

Software licensing ....................................................................................................134

Maintenance ...............................................................................................................135

Chapter 8: Cleaning and Disinfecting

Cleaning and disinfecting the system and transducer ...............................137

Before getting started ....................................................................................137

Determining the required cleaning and disinfecting level ..............138

Option A: Semi-critical cleaning of system and transducer and disinfecting of system and transducer

(semi-critical uses) ...........................................................................................139

Option B: Non-critical cleaning and low-level disinfecting of system and transducer (non-critical uses) 143

.................................................... Cleaning and disinfecting the battery 145

Cleaning the footswitch ................................................................................145

Cleaning and disinfecting the ECG cable and slave cable ................ 145

Chapter 9: Safety

Ergonomic safety ......................................................................................................147

Position the system ......................................................................................... 148

Position yourself ............................................................................................... 148

Take breaks, exercise, and vary activities ................................................149

Electrical safety ..........................................................................................................149

Electrical safety classification ......................................................................152

Equipment safety ......................................................................................................152

Battery safety ..............................................................................................................153

Clinical safety ..............................................................................................................154

Hazardous materials ................................................................................................ 155

Electromagnetic compatibility ............................................................................ 156

Wireless transmission ..................................................................................... 157

Electrostatic discharge .................................................................................. 157

Separation distance ........................................................................................ 159

Compatible accessories and peripherals ................................................ 159

Manufacturer’s declaration .......................................................................... 162

Labeling symbols ...................................................................................................... 165

Specifications ............................................................................................................. 170

Dimensions ........................................................................................................ 170

Environmental limits ..................................................................................... 170

Electrical specifications ................................................................................. 171

Battery specifications ..................................................................................... 171

Standards ..................................................................................................................... 172

Electromechanical safety standards ......................................................... 172

EMC standards classification ....................................................................... 172

Biocompatibility standards .......................................................................... 173

Airborne equipment standards .................................................................. 173

DICOM standard ............................................................................................... 173

HIPAA standard ................................................................................................ 173

Chapter 10: Acoustic Output

ALARA principle ........................................................................................................ 175

Applying the ALARA principle .................................................................... 175

Direct controls .................................................................................................. 176

Indirect controls ............................................................................................... 176

Receiver controls ............................................................................................. 176

Acoustic artifacts ...................................................................................................... 176

Guidelines for reducing MI and TI ....................................................................... 177

Output display ........................................................................................................... 180

MI and TI output display accuracy ............................................................. 181

Factors that contribute to display uncertainty ..................................... 181

Related guidance documents ..................................................................... 182

Transducer surface temperature rise ................................................................. 182

Acoustic output measurement ............................................................................ 183

In Situ, derated, and water value intensities .......................................... 183

Tissue models and equipment survey ..................................................... 185

Acoustic output tables ............................................................................................ 186

Terms used in the acoustic output tables ............................................... 233

Acoustic measurement precision and uncertainty ............................. 234

Glossary

Terms ............................................................................................................................. 237

Abbreviations ............................................................................................................. 239

About the SonoSite Edge II User Guide 1

Chapter 1: Introduction

About the SonoSite Edge II User Guide

The SonoSite Edge II Ultrasound System User Guide provides information about configuring and using the

SonoSite Edge II ultrasound system including:

Managing patient data

Performing exams

Taking measurements and calculations

Cleaning and disinfecting the system

The information and procedures in this user guide apply to the SonoSite Edge II ultrasound system and its

included accessories. Other accessories and third-party equipment are subject to their own instructions and

restrictions.

The SonoSite Edge II Ultrasound System User Guide is intended for a user familiar with ultrasound. It does not

provide training in sonography, ultrasound, or clinical practices. Before using the system, you must complete

such training.

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.

2Gettinghelp

Getting help

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

Instructional videos available on-line.

FUJIFILM SonoSite Technical Support:

Printed in the U.S.

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 service@sonosite.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

About the system 3

Chapter 2: Getting Started

Use this section to help familiarize yourself with the SonoSite Edge II ultrasound system and its uses.

About the system

The SonoSite Edge II is a portable, software-controlled device using all-digital architecture. The system has

multiple configurations and feature sets used to acquire and display high-resolution, real-time ultrasound

images. Features available on your system depend on system configuration, transducer, and exam type.

A license key is required to activate the software. See “Software licensing” on page 134. On occasion, a

software upgrade may be required. FUJIFILM SonoSite provides a USB device containing the software. One

USB device can be used to upgrade multiple systems.

Intended use

The SonoSite Edge II ultrasound system is a general purpose ultrasound system intended for use by qualified

physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the

human body.

The system is used with a transducer attached and is powered either by battery or by AC electrical power. The

clinician is positioned beside the patient and places the transducer onto (or into for invasive procedures) the

patient’s body where needed to obtain the desired ultrasound image.

The system transmits ultrasound energy into the patient’s body to obtain ultrasound images as described

below.

Abdominal Imaging Applications

You can assess the liver, kidneys, pancreas, spleen, gallbladder, bile ducts, transplanted organs, abdominal

vessels, and surrounding anatomical structures for the presence or absence of pathology transabdominally.

Cardiac Imaging Applications

You can assess the heart size and function, cardiac valves, great vessels, visualize blood flow through cardiac

valves, and assess for the presence or absence of pathology. In addition, you can identify the presence and

location of fluid around the heart and lungs used to assist in pericardiocentesis and thoracentesis procedures.

You can detect normal lung motion for the presence or absence of pathology.

4Intendeduse

You can obtain the patient’s electrocardiogram (ECG). The ECG is used for timing of cardiac events.

Gynecology and Infertility Imaging Applications

You can assess the uterus, ovaries, adnexa, and surrounding anatomical structures for the presence or absence

of pathology transabdominally or transvaginally.

Interventional Imaging Applications

You can use the system for ultrasound guidance in biopsy and drainage procedures, vascular line placement,

peripheral nerve blocks, ova harvesting, amniocentesis and other obstetrical procedures, and provide

assistance during abdominal, breast, and neurological surgery.

Obstetrical Imaging Applications

You can assess the fetal anatomy, viability, estimated fetal weight, gestational age, amniotic fluid, and

surrounding anatomical structures for the presence or absence of pathology transabdominally or

transvaginally. CPD and Color imaging are intended for high-risk pregnant women. High-risk pregnancy

indications include, but are not limited to, multiple pregnancy, fetal hydrops, placental abnormalities, as well

as maternal hypertension, diabetes, and lupus.

Pediatric and Neonatal Imaging Applications

You can assess the pediatric and neonatal abdominal, pelvic and cardiac anatomy, pediatric hips, neonatal

head, and surrounding anatomical structures for the presence or absence of pathology.

WARNING The ECG is not used to diagnose cardiac arrhythmias and is not designed for long

term cardiac rhythm monitoring.

WARNINGS To prevent injury or misdiagnosis, do not use this system for Percutaneous

Umbilical Blood Sampling (PUBS) or in vitro Fertilization (IVF) The system has not

been validated to be proven effective for these two uses.

CPD or Color images can be used as an adjunctive method, not as a screening

tool, for the detection of structural anomalies of the fetal heart and as an

adjunctive method, not as a screening tool, for the diagnosis of Intrauterine

Growth Retardation (IUGR).

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