SII User Guide Feb 2021

Manufacturer

EC Authorized Representative

Australia Sponsor

FUJIFILM SonoSite, Inc.

FUJIFILM SonoSite B.V.

FUJIFILM SonoSite Australasia Pty Ltd

21919 30th Drive SE

Joop Geesinkweg 140

114 Old Pittwater Road

Bothell, WA 98021 USA

1114 AB Amsterdam,

BROOKVALE, NSW, 2100

T: 1-888-482-9449 or 1-425-951-1200

The Netherlands

Australia

F: 1-425-951-1201

Caution

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

SonoSite SII, SonoHD2, SonoMB, SONOSITE and the SONOSITE logo are trademarks and registered trademarks of FUJIFILM SonoSite, Inc. in various jurisdictions. FUJIFILM is a registered trademark of FUJIFILM Corporation 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 9,895,133; US 9,671,491; US 9,151,832; US 8,861,822; US 8,500,647; US 8,435,183; US 8,398,408; US 8,213,467; US 8,137,278; US 8,088,071; US 8,066,642; US 7,978,461; US 7,849,250; US 7,686,766; US 7,591,786; US 7,588,541; US 7,534,211; US 7,169,108; US 6,962,566; US 6,648,826; US 6,575,908; US 6,569,101; US D625,015; US D625,014; US D559,390; CA 2796067; CN 101868184; CN 103237499; CN 105997139; EP 1552792, validated in DE, FR, and GB; EP 1589878, validated in DE, FR, and GB; EP 2187813, validated in FR and DE; EP 2555683, validated in CH, DE, FR, GB, IE, and NL; DE 602004023816; ES 2337140; JP 5452491; JP 5894571; JP 5972258; JP 6258367; JP 6322321; JP 6462164. Part number: P20536-06 Publication date: February 2021 Copyright © 2021 FUJIFILM SonoSite, Inc. All rights reserved.

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1. Introduction

CONTENTS

Document conventions ... 1-1 Getting help ... 1-2

2. Getting Started

About the system ... 2-1 License Key ... 2-1 Preparing the system ... 2-2 Components and connectors ... 2-2 Installing or removing the battery ... 2-3 Using AC power and charging the battery ... 2-4 Turning the system on or off ... 2-5 Connecting transducers ... 2-6 Inserting and removing USB storage devices ... 2-7 System controls ... 2-9 Screen layout ... 2-9 General interaction ...2-11 Touchpad ...2-11 Touch screen ...2-12 Control buttons and knobs ...2-12 Entering text ...2-12 Preparing transducers ...2-14 Acoustic coupling gel ...2-14 Intended uses ...2-15

3. System Setup

Displaying the Settings pages ... 3-1 Administration setup ... 3-2 Security settings ... 3-2 Administering users ... 3-3 Exporting and clearing the Event log ... 3-5 Logging in as user ... 3-5 Choosing a secure password ... 3-5 System setup ... 3-6 Annotations settings ... 3-6 Audio, Battery settings ... 3-7

iii

Cardiac Calculations settings ... 3-8 Connectivity settings ... 3-8 Date and Time settings ... 3-10 Display Information settings ... 3-10 Footswitch settings ... 3-10 Network Status settings ... 3-11 OB Calculations settings ... 3-11 Presets settings ... 3-11 System Information settings ... 3-13 USB Devices settings ... 3-13 Limitations of JPEG format ... 3-14

4. Imaging Imaging modes ... 4-1 2D imaging ... 4-1 M Mode imaging ... 4-3 CPD and Color imaging ... 4-4 PW and CW Doppler imaging ... 4-5 Adjusting depth and gain ... 4-8 Freezing, viewing frames, and zooming ... 4-8 Needle visualization ... 4-10 About Steep Needle Profiling technology ... 4-10 Needle size and angle ... 4-12 Additional recommendations ... 4-13 Centerline ... 4-13 Imaging modes and exams available by transducer ... 4-14 ... 4-15 Annotating images ... 4-20 Patient information form ... 4-22 Patient information form fields ... 4-24 Images and clips ... 4-25 Saving images and clips ... 4-25 Reviewing patient exams ... 4-26 Printing, exporting, and deleting images and clips ... 4-28 ECG ... 4-30 ECG controls ... 4-31

5. Measurements and Calculations Measurements ... 5-1 Working with calipers ... 5-1 Saving measurements ... 5-3 2D measurements ... 5-4 M Mode measurements ... 5-5 Doppler measurements ... 5-6

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Calculations ... 5-9 Calculations menu ... 5-9 Performing and saving measurements in calculations ... 5-10 Displaying and deleting saved measurements in calculations ... 5-10 General calculations ... 5-11 Arterial calculations ... 5-13 Cardiac calculations ... 5-15 MSK calculations ... 5-31 Gynecology (Gyn) calculations ... 5-32 OB calculations ... 5-33 Patient report ... 5-36 MSK worksheets ... 5-37

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 ... 6-13 General references ... 6-18

7. Troubleshooting and Maintenance Troubleshooting ... 7-1 Software licensing ... 7-2 Maintenance ... 7-3 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 ... 8-12 Cleaning accessories ... 8-13 Cleaning and disinfecting the ECG cable and slave cable ... 8-13

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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 classification ... 9-4 Electrical safety ... 9-4 Equipment safety ... 9-6 Battery safety ... 9-7 Clinical safety ... 9-8 Hazardous materials ... 9-9 Electromagnetic compatibility ... 9-9 Wireless transmission ... 9-10 Electrostatic discharge ... 9-11 Separation distance ... 9-13 Compatible accessories and peripherals ... 9-13 Manufacturer’s declaration ... 9-15 Labeling symbols ... 9-22 Specifications ... 9-29 System ... 9-30 Imaging modes ... 9-30 Images and clips storage ... 9-30 Accessories ... 9-30 Peripherals ... 9-31 Environmental limits ... 9-31 Electrical specifications ... 9-31 Battery specifications ... 9-32 Standards ... 9-32 Electromechanical safety standards ... 9-32 EMC standards classification ... 9-33 Biocompatibility standards ... 9-33 Airborne equipment standards ... 9-33 DICOM standard ... 9-33 HIPAA standard ... 9-34

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 Guidelines for reducing MI and TI ... 10-3 Output display ... 10-6 MI and TI output display accuracy ... 10-7

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Factors that contribute to display uncertainty ... 10-8 Related guidance documents ... 10-8 Transducer surface temperature rise ... 10-9 Acoustic output measurement ... 10-9 Tissue models and equipment survey ... 10-11 Acoustic output tables ... 10-12 Acoustic measurement precision and uncertainty ... 10-69

11. IT Network Functions ... 11-1 Network for connecting the device ... 11-1 Specifications for the connection ... 11-1 Hardware specification ... 11-1 Software Specifications ... 11-1 Security ... 11-2 Data flow ... 11-2

A. Glossary Terms ...A-1 Abbreviations ...A-3

Index ...B-1

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Chapter 1

Introduction This SonoSite SII Ultrasound System User Guide provides information on preparing and using the SonoSite SII 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 this version Features

Description

Cleaner removed

Removed the PI Spray II cleaner from the Cleaning and disinfecting chapter.

Labeling symbols updated

Updated the Labeling symbols to comply with new regulations.

Incorporated user guide supplement and erratas

P21465-05 P21659-09 P22338-04

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.

Introduction

1-1

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 . Symbols and terms used on the system and transducer are explained in “Labeling symbols” on page 9-22 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:

1-2

United States or Canada

+1 877-657-8118

Other regions

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

Europe and Middle East

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 and Pacific

+61 2 9938 8700

Fax

+1 425-951-6700

Email

Main: [email protected] United Kingdom: [email protected] Europe, Middle East, and Africa: [email protected] Asia and Pacific: [email protected]

Web

www.sonosite.com

Introduction

Getting Started

Chapter 2

About the system The SonoSite SII ultrasound system is a portable, software-controlled device using all-digital architecture. The SonoSite SII includes the following configurations: S-Total S-Vascular S-Vet 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.

License Key A license key is required to activate the software. Refer to “Software licensing” on page 7-2. On occasion, a software upgrade may be required. FUJIFILM SonoSite provides a USB device containing the software. One USB device can upgrade multiple systems. Basic steps 1 Turn the system on. For power switch location, refer to Figure 2-1 on page 2-2. 2 Attach a transducer. 3 Tap Patient, and then tap Information. 4 Complete the patient information form. If all imaging modes are licensed, press Mode, and select an imaging mode. Note

Getting Started

By default, the system is in 2D imaging.

2-1

Preparing the system Components and connectors The back of the system has compartments for the battery and two transducers as well as connectors for USB devices, power cord, network cable, and more. Refer to Figure 2-1.

Power switch Connector block (see detail below) Battery Mounting holes Connector block detail ECG port

USB ports

RJ45 Network port

HDMI out

Printer output

DC power in

Transducer connector ports

Figure 2-1 System Back

2-2

Getting Started

Each connector has a symbol that describes its use. USB DC input Composite video out Print control Ethernet HDMI

HDMI video out

Installing or removing the battery WARNINGS To avoid injury to the operator and to prevent damage to the ultrasound system, inspect the battery for leaks prior to installing. To avoid data loss and to conduct a safe system shutdown, always keep a battery in the system. To install the battery 1 Ensure the ultrasound system is turned off. 2 Disconnect the power supply. 3 At the back of the system, slide the four prongs on the end of the battery into the slots on the right side of the battery compartment.

Getting Started

2-3

4 Push the battery into the battery compartment and press until the latch engages.

To remove the battery 1 Ensure the ultrasound system is turned off. 2 Disconnect the power supply. 3 Slide the locking lever on the left side of the battery, and lift the battery up.

Using AC power and charging the battery The battery charges when the system is connected to the AC power supply. A fully discharged battery recharges in less than five hours. When the system is connected to AC power, the system can operate and charge the battery at the same time. Depending on the imaging mode and the display brightness, the system can run on battery power for up to two hours. When running on battery power, the system may not restart if the battery charge is low. If the system will not start due to a low battery condition, connect the system to AC power. WARNINGS Verify that the hospital supply voltage corresponds to the power supply voltage range. Refer to “Electrical specifications” on page 9-31. Plug the system only into a grounded hospital-grade outlet. Use only power cords provided by FUJIFILM SonoSite with the system.

2-4

Getting Started

To operate the system using AC power Caution

Be sure to keep the battery inserted in the system even if the system is connected to the AC power supply.

1 Connect the DC power cable from the power supply to the power connector on the system. Refer to Figure 2-1 on page 2-2. 2 Connect the AC power cord to the power supply, and then plug it in to a hospital-grade electrical outlet. To separate the system (and any connected equipment) from a supply mains 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.

 Disconnect the AC power cord from 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.

To turn the system on or off  Press the power switch. Refer to Figure 2-1 on page 2-2.

To wake up the system To conserve battery life while the system is on, the system goes into sleep mode if untouched for a preset time. To adjust the time for sleep delay, refer to “Audio, Battery settings” on page 3-7.  Press a key, or touch the touchpad.

Getting Started

2-5

Connecting transducers WARNING

To avoid injury to the patient, do not place the connector on the patient.

Caution

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

To connect a transducer 1 Pull the transducer latch up, and rotate it clockwise. 2 Align the transducer connector with the connector on the back of the system. 3 Insert the transducer connector into one of the transducer ports on the system.

4 Turn the latch counterclockwise.

5 Press the latch down, securing the transducer connector to the system.

2-6

To remove a transducer 1 Pull the transducer latch up, and rotate it clockwise.

2 Pull the transducer connector away from the system.

Inserting and removing USB storage devices 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. Although the images and clips cannot be viewed from a USB storage device on the ultrasound system, you can remove the USB storage device and view the images on your PC. You can also import and export user accounts and the Event log using a USB storage device. There are three USB ports located on the back of the system near the top. For additional USB ports, you can connect a USB hub into any USB port. WARNINGS

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

Caution

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

Note

The system does not support password-protected or encrypted USB storage devices. Make sure that the USB storage device you use does not have password protection or encryption enabled. USB storage devices must be in FAT-32 format.

Getting Started

2-7

To insert a USB storage device Insert the USB storage device into a USB port on the system. Refer to Figure 2-1 on page 2-2. The USB storage device is ready when the USB icon appears. To remove a USB storage device Removing the USB storage device while the system is exporting may cause the exported files to be corrupted or incomplete. 1 Wait at least five seconds after the USB animation stops. 2 Remove the USB storage device from the port.

2-8

Getting Started

System controls 1

Control knobs

Turn to adjust gain, depth, cine buffer, brightness, and more, depending on context. Current functions appear on-screen above the knobs.

2

Freeze key

Press and hold to freeze or unfreeze the image.

3

Touchpad

When the touchpad is lit, use it to control items displayed on the screen. Double-tap the touchpad to switch between functions.

4

Touchpad key

Works in conjunction with the touchpad. Tap to activate an item on-screen, or to switch between functions.

5

Print key

Available only when a printer is connected to the system. Tap to print from a live or frozen scan.

6

Save keys

Tap one of these keys to save an image or a clip.

7

Image mode

Tap one of these keys to change the imaging mode.

8

System controls

Change system settings, switch transducers, add labels, or see patient information.

9

Image, ECG, and Doppler controls

Use these to adjust the image, select the ECG function, or select the Doppler imaging mode.

10

Touchscreen

Use the touchscreen the same way you would use the touchpad.

10

8

9 9 1

2

3

4

5

7

6

Figure 2-2 Control layout

Screen layout The layout of the SonoSite SII system screen and the controls that appear on it change according to imaging mode or the specific task you are performing, such as measuring or annotating. During scanning, the following information is available:

Getting Started

2-9

Patient name Image status

System controls

Exam number

Facility

Date and time Exam type Transducer Mechanical & thermal indexes

Depth Image controls Figure 2-3 Screen layout

2-10

Getting Started