EDGE User Guide June 2019

USER GUIDE

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 FUJIFILM SonoSite B.V. Joop Geesinkweg 140 1114 AB Amsterdam, The Netherlands

Australia Sponsor FUJIFILM SonoSite Australasia Pty Ltd Suite 9, 13a Narabang Way Belrose, New South Wales 2085 Australia

Caution:

United States law restricts this device to sale by or on the order of a physician.

Edge, SiteLink, SonoCalc, SonoHD2, SonoMB, SonoMBe, 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 8,439,840; 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; 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: 4696150; KR: 532359; KR: 528102; NO: 326814; NO: 326202 and pending.

P15200-04 06/2019 Copyright © 2019 FUJIFILM SonoSite, Inc. All Rights reserved.

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Contents Introduction Conventions, symbols, and terms ... ix Customer comments ... ix

Chapter 1: Getting Started About the system ...1 Preparing the system ...1 Installing or removing the battery ...1 Using AC power and charging the battery ...2 Turning the system on or off ...3 Connecting transducers ...3 Inserting and removing USB storage devices ...4 System controls ...6 Screen layout ...8 General interaction ...9 Touchpad and cursor ...9 On-screen controls ...9 Annotation and text ...10 Preparing transducers ...11 Training videos ...12 Intended uses ...13

Chapter 2: System Setup Displaying the setup pages ...15 Restoring default settings ...15 A & B Key, Footswitch setup ...15 Administration setup ...15 Security settings ...16 User setup ...16 Exporting or importing user accounts ...17 Exporting and clearing the Event log ...17 Logging in as user ...18 Choosing a secure password ...18 Annotations setup ...18 Audio, Battery setup ...19 Cardiac Calculations setup ...19 Connectivity setup ...19 Date and Time setup ...20 Display Information setup ...20 IMT Calculations setup ...20 Network Status setup ...20

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OB Calculations setup ...20 OB Custom Measurements setup ...21 OB Custom Tables setup ...21 Presets setup ...22 System Information setup ...22 USB Devices setup ...22 Limitations of JPEG format ...23 eFilm Lite image-viewer ...23

Chapter 3: Imaging Imaging modes ...25 2D imaging ...25 M Mode imaging ...26 CPD and color Doppler imaging ...27 PW and CW Doppler imaging ...28 Adjusting depth and gain ...30 Freezing, viewing frames, and zooming ...30 Needle visualization ...31 About MBe ...31 Needle size and angle ...32 MBe subcontrols ...32 Additional recommendations ...33 Imaging modes and exams available by transducer ...33 Annotating images ...35 Patient information form ...36 Images and clips ...38 Saving images and clips ...38 Reviewing patient exams ...39 Printing, exporting, and deleting images and clips ...40 ECG Monitoring ...41

Chapter 4: Measurements and Calculations Measurements ...43 Working with calipers ...43 2D measurements ...44 M Mode measurements ...45 Doppler measurements ...45 General calculations ...47 Calculations menu ...47 Performing and saving measurements in calculations ...47 Displaying, repeating, and deleting saved measurements in calculations ...48 EMED calculations ...48 Percent reduction calculations ...48

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Volume calculations ...50 Volume flow calculations ...51 Exam-based calculations ...53 Cardiac calculations ...53 Gynecology (Gyn) calculations ...62 IMT calculations ...62 OB calculations ...65 Small Parts calculations ...68 Transcranial Doppler and Orbital calculations ...69 Vascular calculations ...71 Patient report ...72 Vascular and cardiac patient reports ...72 TCD patient report ...73 OB patient report ...73 EMED and MSK worksheets ...73

Chapter 5: Measurement References Measurement accuracy ...75 Sources of measurement errors ...76 Measurement publications and terminology ...77 Cardiac references ...77 Obstetrical references ...82 Gestational age tables ...83 Growth analysis tables ...84 Ratio calculations ...86 General references ...86

Chapter 6: Troubleshooting and Maintenance Troubleshooting ...89 Software licensing ...90 Maintenance ...90 Cleaning and disinfecting ...91 Cleaning and disinfecting the ultrasound system ...92 Cleaning and disinfecting transducers ...92 Cleaning and disinfecting the battery ...94 Cleaning the footswitch ...94 Cleaning and disinfecting ECG cables ...94

Chapter 7: Safety Ergonomic safety ...95 Position the system ...96 Position yourself ...96 Take breaks, exercise, and vary activities ...97 Electrical safety ...97 Electrical safety classification ...99

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Equipment safety ...100 Battery safety ...100 Clinical safety ...102 Hazardous materials ...103 Electromagnetic compatibility ...103 Electrostatic discharge ...104 Separation distance ...106 Compatible accessories and peripherals ...107 Guidance and manufacturer’s declaration ...109 Labeling symbols ...113 Specifications ...117 Dimensions ...117 Environmental limits ...117 Electrical specifications ...118 Battery specifications ...118 Standards ...118 Electrical safety standards ...118 EMC standards classification ...119 Acoustic standards ...119 Biocompatibility standards ...119 Airborne equipment standards ...120 DICOM standard ...120 HIPAA standard ...120

Chapter 8: Acoustic Output ALARA principle ...121 Applying the ALARA principle ...121 Direct controls ...122 Indirect controls ...122 Receiver controls ...122 Acoustic artifacts ...122 Guidelines for reducing MI and TI ...123 Output display ...125 MI and TI output display accuracy ...126 Factors that contribute to display uncertainty ...127 Related guidance documents ...127 Transducer surface temperature rise ...128 Acoustic output measurement ...128 In Situ, derated, and water value intensities ...129 Tissue models and equipment survey ...130 Acoustic output tables ...131 Terms used in the acoustic output tables ...170 Acoustic measurement precision and uncertainty ...171

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Glossary Terms ...173 Abbreviations ...175

Index ...185

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Introduction

The user guide is intended for a reader familiar with ultrasound techniques and who has received training in sonography and clinical practices. Before using the system, you must receive such training. See the applicable FUJIFILM SonoSite accessory user guide for information on using accessories and peripherals. See the manufacturer’s instructions for specific information about peripherals.

Conventions, symbols, and terms 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.

•

Numbered steps in procedures must be performed in order.

•

Items in bulleted lists do not require performance in sequence.

•

Single-step procedures begin with .

Customer comments Questions and comments are encouraged. FUJIFILM SonoSite is interested in your feedback regarding the system and the user guide. Please call FUJIFILM SonoSite at 888-482-9449 in the U.S. Outside the U.S., call the nearest FUJIFILM SonoSite representative. For technical support, please contact FUJIFILM SonoSite as follows: FUJIFILM SonoSite Technical Support Phone (U.S. or Canada):

877-657-8118

Phone (Outside U.S. and Canada):

425-951-1330 Or call your local representative.

Fax:

425-951-6700

E-mail:

[email protected]

Web site:

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 6380-5589

Symbols and terms used on the system and transducer are explained in Chapter 1, Chapter 6, Chapter 7, and Glossary.

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Introduction

Edge Ultrasound System User Guide provides information on preparing and using the Edge ultrasound system and on cleaning and disinfecting the system and transducers. It also provides references for calculations, system specifications, and safety and acoustic output information.

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Customer comments

Chapter 1: Getting Started About the system

A license key is required to activate the software. See “Software licensing” on page 90. 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.

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Getting Started

The Edge ultrasound system 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.

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Figure 2 System Back Connectors: (1) DC input connector, (2) Battery, (3) I/O connector, and (4) ECG connector

Basic operating steps 1 Attach a transducer. 2 Turn the system on. (For power switch location, see “System controls” on page 6.) 3 Press the PATIENT key, and complete the patient information form. 4 Press an imaging mode key: 2D, M MODE, COLOR, or DOPPLER.

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Preparing the system 4

Installing or removing the battery 1

WARNING:

To avoid injury to the operator and to prevent damage to the ultrasound system, inspect the battery for leaks prior to installing.

WARNING:

To avoid data loss and to conduct a safe system shutdown, always keep a battery in the system.

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Figure 1 System Front Features: (1) Control panel, (2) AC power indicator, (3) Display, (4) USB ports, (5) Handle

See also “Battery safety” on page 100.

Chapter 1: Getting Started

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To install the battery

To remove the battery

1 Disconnect the power supply from the ultrasound system.

1 Disconnect the power supply from the ultrasound system.

2 Remove the system from the mini-dock (if present) and turn it upside down.

2 Remove the system from the mini-dock (if present) and turn it upside down.

3 Place the battery into the battery compartment, at a slight angle. See Figure 3.

3 Pull up the two locking levers.

4 Slide the battery forward until it locks into place. 5 Slide the two locking levers outward to secure the battery.

4 Slide the battery back. 5 Lift the battery from the compartment.

Using AC power and charging the battery Caution:

When using AC power, position the system to allow easy access to disconnect it.

The battery charges when the system is connected to the AC power supply. A fully discharged battery recharges in less than five hours. The system can run on AC power and charge the battery if AC power is connected to the system directly, to a mini-dock, or to a docking system. The system can run on battery power for up to two hours, depending on the imaging mode and the display brightness. When running on battery power, the system may not restart if the battery is low. To continue, connect the system to AC power. WARNING:

The equipment shall be connected to a center-tapped single phase supply circuit when users in the United States connect the equipment to a 240V supply system.

Caution:

Verify that the hospital supply voltage corresponds to the power supply voltage range. See “Electrical specifications” on page 118.

Figure 3 Install the Battery

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Preparing the system

Connecting transducers

1 Connect the DC power cable from the power supply to the connector on the system. See Figure 2 on page 1.

WARNING:

To avoid injury to the patient, do not place the connector on the patient. Operate the ultrasound system in a docking system or on a flat hard surface to allow air flow past the connector.

Caution:

To avoid damaging the transducer connector, do not allow foreign material in the connector.

Push the cable in firmly to ensure a secure attachment. 2 Connect the AC power cord to the power supply and to a hospital-grade electrical outlet.

To separate the system (and any connected equipment) from a supply mains Note: Disconnecting only the DC power cable from the system or dock does not separate the system from the 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.

Turning the system on or off Caution:

Do not use the system if an error message appears on the display. Note the error code and turn off the system. Call FUJIFILM SonoSite or your local representative.

Getting Started

To operate the system using AC power

To connect a transducer 1 Remove the system from the mini-dock (if present), and turn it upside down. 2 Pull the transducer latch up, and rotate it clockwise. 3 Align the transducer connector with the connector on the bottom of the system. 4 Insert the transducer connector into the system connector. 5 Turn the latch counterclockwise. 6 Press the latch down, securing the transducer connector to the system.

To turn the system on or off  Press the power switch. (See “System

controls” on page 6.)

To wake up the system To conserve battery life while the system is on, the system goes into sleep mode if the lid is closed or if the system is untouched for a preset time. To adjust the time for sleep delay, see “Audio, Battery setup” on page 19.  Press a key, touch the touchpad, or open the lid.

Chapter 1: Getting Started

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Inserting and removing USB storage devices You can use a USB storage device to import and export various logs and setup configurations and to archive images and clips. Images and clips are saved to internal storage and are organized in a sortable patient list. You can archive the images and clips from the ultrasound system to a PC using a USB storage device or Ethernet connection. Although the images and clips cannot be viewed from a USB storage device on the ultrasound system, you can remove the device and view them on your PC. There are two USB ports on the system, and one on the mini-dock. For additional USB ports, you can connect a USB hub into any USB port. Note: The system does not support password-protected USB storage devices. Make sure that the USB storage device you use does not have password protection enabled. See also “Troubleshooting” on page 89. WARNING:

• Do not remove the USB storage device or turn off the ultrasound system while the system is exporting. • Do not bump or otherwise apply pressure to the USB storage device while it is in a USB port on the ultrasound system. The connector could break.

Figure 4 Connect the Transducer

To remove a transducer 1 Pull the transducer latch up, and rotate it clockwise. 2 Pull the transducer connector away from the system.

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Preparing the system

To avoid damaging the USB storage device and losing patient data from it, observe the following:

Caution:

If the USB icon does not appear in the system status area on-screen, the USB storage device may be defective or password-protected. Turn the system off and replace the device.

To insert a USB storage device  Insert the USB storage device into any USB port

on the system or mini-dock. See Figure 1 on page 1. The USB storage device is ready when the USB icon appears.

Getting Started

To view information about the device, see “USB Devices setup” on page 22.

To remove a USB storage device Removing the USB storage device while the system is exporting to it may cause the exported files to be corrupted or incomplete. 1 Wait five seconds after the USB animation stops. 2 Remove the USB storage device from the port.

Chapter 1: Getting Started

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System controls 1

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Control keys

Adjust on-screen controls.

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Alphanumeric keys

Enters text and numbers.

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Annotation keys

See “Alphanumeric keyboard” on page 10.

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Gain NEAR

Adjusts the gain applied to the near field of the image.

FAR

In live imaging, adjusts the gain applied to the far field of the image. On a frozen PW Doppler image, adjusts the angle.

GAIN

In live imaging, adjusts the overall gain applied to the entire image. On a frozen image, moves the cine buffer.

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AUTO GAIN

Adjusts gain automatically.

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DEPTH UP, DEPTH DOWN

Decreases and increases imaging depth.

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ZOOM

Magnifies the image 100%.

System controls

SET CALIPER

Sets a trace measurement. Displays calipers on-screen for measuring.

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CALCS

Turns the calculations menu on and off.

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Touchpad

Selects, adjusts, and moves items on-screen.

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FREEZE

Stops live imaging and displays a frozen image.

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SAVE

Saves an image to internal storage. If configured, also saves calculations to the report. See “Presets setup” on page 22.

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SAVE CALC CLIP

Saves calculations and their measurements to the patient report. Saves a clip to internal storage.

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A & B shortcut keys

Keys that you can program to perform common tasks.

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Imaging Modes M MODE

Turns M Mode on, toggles between M-line and M Mode trace.

DOPPLER

Turns Doppler on, toggles between D-line and Doppler trace.

COLOR

Turns CPD/Color on and off.

2D

Turns 2D on.

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UPDATE

Toggles between dual and duplex screens and imaging modes in M Mode and Doppler (for example, between D-line and Doppler spectral trace).

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SELECT

Used with the touchpad to select items on-screen. Also switches between Color and Doppler controls, calipers for measurement, pictograph-marker position and angle, frozen images in duplex and dual screens, and arrow position and orientation.

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Forms

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PATIENT

Accesses patient information.

EXAM

Opens exam menu.

REVIEW

Accesses the patient list, saved images, and archiving functions.

REPORT

Accesses the patient report and EMED worksheets.

Power switch

Turns system on and off.

Chapter 1: Getting Started

Getting Started

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Screen layout 9 1 2 3 4

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Mode Data Area

Current imaging mode information (for example, Gen, Res, THI, and PW).

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Orientation Marker

Indication for image orientation. In dual and duplex images, the orientation marker is green on the active screen.

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Text

Text entered using keyboard.

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Pictograph

Pictograph to indicate anatomy and transducer position. You can select anatomy and screen location.

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Calculations Menu

Contains available measurements.

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Image

Ultrasound image.

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Measurement and Calculations Data Area

Current data on measurements and calculations.

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On-screen Controls

Controls available in the current context.

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Patient Header

Header details such as current patient name, ID number, user, and date/time. Specified on the display information setup page.

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System Status

Information on system status (for example, exam type, transducer, AC connected, battery charging, and USB).

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Depth Marker

Marks in .5 cm, 1 cm, and 5 cm increments depending on depth.

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Screen layout

General interaction Touchpad and cursor Caution:

Action Performs an action. You can press either key. Or you can instead select the control by using the touchpad and the SELECT key.

Figure 5 On-screen controls (2D imaging shown)

Use the touchpad to adjust and move objects on-screen. The touchpad controls caliper position, CPD or Color box position and size, the cursor, and more. The arrow keys control much of the same functionality as the touchpad. The cursor appears in the setup pages, the patient information form, and patient report. You control the cursor through the touchpad. For example, in the patient information form, place the cursor over the last name field and press the SELECT key to activate that field. Additionally, you can use the cursor to select check boxes and items in lists.

On-screen controls The on-screen controls let you make adjustments and select settings. The controls available depend on context. Each control is controlled by the pair of keys below it. Depending on the control, the keys function in one of four ways: Cycle Moves through a list of settings continuously. The upper key cycles upward. The lower key cycles downward. Up-Down Moves through a list of settings, stopping at the top or bottom. The upper key moves upward. The lower key moves downward. By default, a beep sounds when you reach either end of the range. (See “Audio, Battery setup” on page 19.)

Chapter 1: Getting Started

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Getting Started

Make sure to keep the touchpad dry while in use. Moisture on the touchpad can cause the cursor to respond erratically.

On-Off Turns a feature on or off. You can press either key. In forms, you can instead select the control by using the touchpad and the SELECT key.