X-Porte User Guide Nov 2015

Manufacturer

EC Authorized Representative

Australia Sponsor

FUJIFILM SonoSite, Inc.

Emergo Europe

FUJIFILM SonoSite Australasia Pty Ltd

21919 30th Drive SE

Molenstraat 15

114 Old Pittwater Road

Bothell, WA 98021 USA

2513 BH, The Hague

BROOKVALE, NSW, 2100

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

The Netherlands

Australia

F: 1-425-951-1201

Caution

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

SonoMB, SonoSite, Steep Needle Profiling, X-Porte, and the SonoSite logo are registered and unregistered 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 8,216,146; US 8,213,467; US 8,147,408; US 8,137,278; US 8,088,071; US 8,066,642; US 7,804,970; US 7,740,586; 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 6,471,651; 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: 727381; AU: 730822; CA: 2,371,711; CA: 2,372,152; CN: 97113678.5; CN: 98106133.8; CN 98108973.9; DE: 602004023816.3; DE: 602004027882.3; DE: 60029777.2; DE: 60034670.6; DE: 69730563.5; DE: 69830539.6; DE: 69831698.3; EP: 0815793; EP: 0875203; EP 0881492; EP: 1180971; EP 1180970; EP: 1589878; EP: 1552792; ES: 0881492; ES: 1552792; ES: 159878; ES: 2229318; FR: 0815793; FR: 0875203; FR: 0881492; FR: 1180970; FR: 1552792; FR: 158978; GB: 0815793; GB: 0875203; GB: 0881492; GB: 1180970; GB: 1180971; GB: 1552792; GB: 158978; IT: 0815793; IT: 0881492; IT: 1552792; IT: 1589878; JP: 4696150; KR: 528102; KR: 532359; NO: 326814; NO: 326202. Part Number: P14645-03 Publication Date: November 2015 Copyright © 2015 FUJIFILM SonoSite, Inc. All Rights reserved.

CONTENTS

Chapter 1: Introduction About the X-Porte User Guide ...1 Welcome to the X-Porte User Guide ...2 Document conventions ...2 Getting help ...3

Chapter 2: Getting started About the system ...5 Accessories and peripherals ...7 Preparing the system ...7 Turning on the system ...7 Adjusting the height and angle ...8 USB devices ...9 General interaction ... 11 Clinical monitor ... 11 VGA video output ... 12 Touch panel ... 12 Onscreen keyboard ... 14 Preparing transducers ... 15 Connecting transducers ... 15 Selecting a transducer and exam type ... 18 Gel ... 23 Sheaths ... 24 Ports ... 24 Battery charge indicator ... 25 Transporting the system ... 25 Visual Guide videos ... 26 Intended uses ... 27

Chapter 3: Setting up the system Administration settings ... 31 About security settings ... 32 Managing the Administrator account ... 32 Protecting patient information ... 33 Adding and managing user accounts ... 34 Logging in ... 35

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CONTENTS

Audio settings ... 36 Calculations settings ... 37 Cardiac calculations settings ... 37 Obstetrics calculations settings ... 37 CDA Report settings ... 41 Connectivity settings ... 42 Importing and exporting connectivity settings ... 43 DICOM ... 44 Configuring the system for DICOM transfer ... 45 Connecting to the network ... 45 DICOM configuration pages ... 47 Associating devices with locations ... 55 Date and Time settings ... 56 Display Information settings ... 57 Logs ... 58 Network Status settings ... 59 Power and Battery settings ... 60 Presets settings ... 60 General preferences ... 61 Brightness ... 61 Labels ... 61 Exam types ... 62 User profile settings ... 64 Importing and exporting ... 66 Routing selections ... 66 Associating routing selections with exams ... 67 Specifying educational DICOM archivers ... 67 System Information settings ... 68 USB settings ... 69 Limitations of JPEG format ... 70 eFilm Lite image-viewer ... 70

Chapter 4: Imaging Imaging modes ... 71 2D ... 72 M Mode ... 72 Color ... 73 Doppler ... 75 Dual ... 76 Imaging controls ... 78

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CONTENTS

Controls in 2D ... 79 Controls in Color ... 84 Controls in M Mode ... 86 Controls in Doppler ... 87 Adjusting depth and gain ... 91 Depth ... 91 Gain ... 92 Freezing, viewing frames, and zooming ... 93 Freezing the image ... 93 Viewing the cine buffer ... 93 Zooming in on the image ... 94 Visualizing needles ... 95 Needle size and angle ... 98 Additional recommendations ... 98 Labeling images ... 99 Adding text labels ... 99 Adding arrows ...100 Adding pictographs ...100 Setting the home position ...101 Labeling during review ...101 Entering patient information ...102 Editing patient information ...103 Entering patient information manually ...103 Entering patient information from the worklist ...103 Ending the exam ...107 Patient form fields ...107 Images and clips ...109 Reviewing ...109 Printing images ...112 Archiving and exporting ...113 Saving images and video clips ...116 DVR recording ...119 Image Gallery ...120 ECG ...121

Chapter 5: Measurements and calculations Measuring ...125 Calipers ...125 Viewing and deleting measurement results ...126 Basic measurements in 2D ...126

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CONTENTS

Basic measurements in M Mode ...127 Basic measurements in Doppler ...128 Assigning measurements to calculations ...131 About calculations ...132 Overview ...133 Percent reduction calculations ...135 Volume calculation ...136 Volume flow calculation ...136 Exam-based calculations ...138 Abdominal calculations ...138 Arterial calculations ...139 Cardiac calculations ...142 Gynecological calculations ...160 Obstetrics calculations ...162 Small Parts and MSK calculations ...168 Acute Care calculations ...169 Transcranial Doppler and Orbital calculations ...172 Worksheets and reports ...175 Report preview ...176 Acute Care and MSK worksheets ...178 Printing reports and worksheets ...179 Displaying reports after the exam has ended ...180 Customizing worksheets ...180 Measuring during review ...181

Chapter 6: Measurement references Measurement accuracy ...183 Sources of measurement errors ...185 Measurement publications and terminology ...185 Cardiac references ...186 Obstetrical references ...196 General references ...202

Chapter 7: Troubleshooting and maintenance Troubleshooting ...205 Software licensing ...206 Maintenance ...209 System backups ...209

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Servicing ...210

CONTENTS

Chapter 8: Cleaning and disinfecting Before getting started ...213 Determining the required cleaning and disinfecting level ...214 Spaulding classifications ...214 Clean and disinfect system and transducer to a high level (semi-critical uses) ...215 Clean and disinfect system and transducer to a low level (non-critical uses) ...220 Storing the transducer ...223 Transporting the transducer ...223 Accessories ...225 Cleaning and disinfecting accessories ...225 Cleaning and disinfecting the stand or Triple Transducer Connect (TTC) ...226 Cleaning the footswitch ...226 Cleaning ECG cables ...227

Chapter 9: Safety Ergonomic safety ...229 Position the system ...230 Position yourself ...230 Take breaks, exercise, and vary activities ...231 Electrical safety ...231 Electrical safety classification ...234 Isolating the X-Porte ultrasound system from power ...234 Equipment safety ...235 Clinical safety ...236 Electromagnetic compatibility ...237 Wireless transmission ...238 Electrostatic discharge ...239 Separation distance ...240 Compatible accessories and peripherals ...241 Manufacturer’s declaration ...243 Labeling Symbols ...247 Specifications ...251 Dimensions ...251

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CONTENTS

Environmental limits ...252 Electrical ...252 Imaging modes ...252 Image and video clip storage capacity ...253 Standards ...254 Electromechanical safety standards ...254 EMC standards classification ...255 DICOM standard ...255 HIPAA standard ...255

Chapter 10: Acoustic output ALARA principle ...257 Applying the ALARA principle ...257 Direct, indirect, and receiver controls ...258 Acoustic artifacts ...259 Guidelines for reducing MI and TI ...259 Output display ...263 MI and TI output display accuracy ...264 Factors that contribute to display uncertainty ...265 Related guidance documents ...265 Transducer surface temperature rise ...266 Acoustic output measurement ...266 Tissue models and equipment survey ...268 Acoustic output tables ...269 Acoustic measurement precision and uncertainty ...324 Terminology in acoustic output tables ...326

Glossary Terms ...329 Abbreviations ...330

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CHAPTER 1

Chapter 1: Introduction This section introduces the X-Porte ultrasound system and this user guide.

About the X-Porte User Guide The X-Porte User Guide is intended for a user familiar with ultrasound. It does not provide training in sonography, ultrasound, or clinical practices. Before using the X-Porte ultrasound system, you must complete such training.

About the X-Porte User Guide

1

Welcome to the X-Porte User Guide

Document conventions A WARNING describes precautions necessary to prevent injury or loss of life. A Caution describes precautions necessary to protect the products. A Note provides supplemental information. Numbered and lettered steps must be performed in a specific order. Bulleted lists present information in list format but do not imply a sequence. For a description of labeling symbols that appear on the product, see “Labeling Symbols” on page 247.

2

About the X-Porte User Guide

Getting help In addition to the X-Porte User Guide, the following are available: Visual Guide videos. See “Visual Guide videos” on page 26. On-system Help: tap MORE, and then tap Help. X-Porte Getting Started Guide. Service manual. 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

E-mail

[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 6380-5589

Printed in the U.S.

Getting help

3

CHAPTER 2

Chapter 2: Getting started WARNING

Do not use the system if it exhibits erratic or inconsistent behavior. Such behavior could indicate a hardware failure. Contact FUJIFILM SonoSite Technical Support.

About the system X-Porte is a portable device that acquires and displays high-resolution, real-time ultrasound images. Features available depend on your system configuration, transducer, and exam type.

About the system

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1 10

2 3

9 4

5

8

4

1

3 6 7

2

Figure 2-1 X-Porte front view

Figure 2-2 X-Porte rear view

1. Clinical monitor, 2. Touch panel, 3. Platform, 4. Hook (4), 5. Transducer connector, 6. Locking wheel (4), 7. Height-adjustment pedal, 8. Basket, 9. USB ports (3),10. Power button

1. Ports on dock, 2. Power cord connector, 3. Battery charge indicator, 4. Ports on dock

A license key is required to activate the software. See “Software licensing” on page 206. Basic operating steps 1 Connect a transducer. See “Connecting transducers” on page 15. 2 Turn on the system. See “Turning on the system” on page 7. 3 Select the transducer and exam type (or use the default selections). See “Selecting a transducer and exam type” on page 18. 4 (Optional) Enter patient information. See “Entering patient information” on page 102. 5 Scan. See “Imaging modes” on page 83.

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About the system

Accessories and peripherals The system supports various accessories and peripherals. See “Compatible accessories and peripherals” on page 241.

Preparing the system Turning on the system WARNINGS

Verify that the hospital supply voltage corresponds to the power supply voltage range.  Plug the system only into a grounded hospital-grade outlet.  Use only power cords provided by FUJIFILM SonoSite with the system.

Cautions

Do not use the system if an error message appears on the clinical monitor. Note the error code and turn off the system. Call FUJIFILM SonoSite or your local representative. When using AC power, position the system to allow easy access to disconnect it.

To turn on the system The system can be powered by the internal battery or by AC power. 1 If you are operating the system using AC power, connect the AC power cord to the stand, and then connect the AC power cord to a hospital-grade outlet. 2 Press the power button. The power button turns green when the system is ready for scanning. If the system does not maintain expected battery charge, or if the battery icon on the clinical monitor does not display the battery charge status, disconnect and reconnect the system to AC power. Connect the system to AC power to maintain battery charge, especially if the system will not be used for several days. To connect the system to AC power (battery charge maintenance) 1 Turn off the system. 2 Disconnect the system from AC power. Preparing the system

7

3 Check the battery switches; ensure that all three switches are depressed to the ʘ symbol, which is the ON position. Note

The system will not charge and maintain the batteries if the battery switches are depressed to the ·O symbol, which is the OFF position.

4 Reconnect the system to AC power. The battery charge indicator at the base of the stand blinks green, and the battery icon on the clinical monitor displays the battery charging state. To turn off the system Note

If the system appears unresponsive, wait several minutes before restarting it. Restarting the system while it is performing data-intensive background activities, such as transferring patient files, can result in loss of patient data. To power down an unresponsive system, press and hold the power button until the system shuts down. This procedure may take 5 seconds or longer.

 Press the power button.

Adjusting the height and angle WARNINGS

Lock the wheels whenever the system is unattended or stationary. To avoid possible injury from an unexpected clinical monitor collapse during system transport, collapse the clinical monitor before system transport (see “To collapse the clinical monitor” on page 9).

To raise or lower the platform  While pressing down the height-adjustment pedal, grasp both sides of the platform and push down or pull

up to the desired height. To lock a wheel  Press down the lever on the wheel.

To unlock the wheel, press up on the bottom of the lever. To adjust the clinical monitor angle  Grasping the clinical monitor on both sides, tilt or rotate it.

8

Preparing the system

To adjust the touch-panel angle  Grasping the sides of the touch panel, pull it forward or push it backward to the desired angle.

To collapse the clinical monitor Always collapse the clinical monitor before system transport. 1 Adjust the touch panel angle to the lowest position. 2 Grasping the clinical monitor on both sides, align it squarely above the touch panel. 3 Fold the clinical monitor downward over the touch panel.

Figure 2-3 Clinical monitor collapsed for system transport

USB devices You can use the USB ports on the system for connecting devices such as a USB printer or a USB memory stick. (For a list of supported devices, see “System components and compatible accessories” on page 241. One of the USB ports at the back of the system is for DVR recording only. See “Ports” on page 24 and “DVR recording” on page 119.

USB memory sticks You can use a USB memory stick to export patient exams, import and export logs and setup configurations, and to import custom obstetric calculation tables. Note

Preparing the system

The system does not support software-encrypted USB memory sticks.

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Cautions

To avoid damaging the USB memory stick and losing patient data from it, observe the following:  Do not remove the USB memory stick or turn off the ultrasound system while the system is exporting.  Do not bump or otherwise apply pressure to the USB memory stick while it is in a USB port on the ultrasound system. The connector could break. If the USB icon does not appear in the system status area on the clinical monitor, the USB memory stick may be defective or software-encrypted. Replace the USB memory stick.

To connect a USB memory stick for importing or exporting  Insert the USB memory stick into a USB port (see “About the system” on page 5).

The USB memory stick is ready when the USB icon

appears onscreen.

To view information about the device, see “USB settings” on page 69. To disconnect a USB memory stick Disconnecting the USB memory stick while the system is exporting to it may cause the exported files to be corrupted or incomplete. 1 If exporting, wait at least five seconds after the USB animation icon

stops.

2 Remove the USB memory stick from the port.

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Preparing the system

General interaction Clinical monitor WARNINGS

FUJIFILM SonoSite recommends against using a monitor other than the clinical monitor provided by FUJIFILM SonoSite. Only the images presented on the system monitor are validated for the intended use of the device. Do not use a monitor connected through the external VGA for medical diagnosis.

The clinical monitor displays the ultrasound image as well as details about the exam and system status. 1

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2

3 7

6

4

5 Figure 2-4 Clinical monitor layout 1

Patient header

5

System status area

2

Measurement and calculation area

6

Imaging mode or modes, controls selected

3

Ultrasound image

7

Depth scale

4

Selected transducer, exam type, and MI and TI values

8

Orientation marker

General interaction

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VGA video output WARNINGS

The VGA video output is intended for non-diagnostic use. To minimize risk of electrical shock, use only with medical-grade devices. To avoid applying unsafe voltage levels to the patient while a device is connected to the external VGA port, do not touch the ultrasound system and the patient simultaneously. For added protection, use an isolation transformer between the connecting device and AC power.

VGA video output resolution is 1280 x 800 at 60 Hz (non-interlaced), Reduced Blanking.

Touch panel The touch panel is where you adjust settings; select the exam type, transducer, and imaging mode; enter patient information; and more. As you adjust the image settings or controls, the results appear on the clinical monitor. When an image is frozen, the touch panel displays an outline of the image. You interact with the touch panel the same as with many other touchscreen devices: Swipe: Move your finger quickly across the panel. Faster than dragging. Drag: Move one or two fingers across the panel, usually to move an object from one location to another. Tap: Quickly touch the panel once; for example, to activate a control. Double-tap: Quickly touch the panel twice with one or more fingers. Pinch or spread: Slide two fingers together or apart on the panel. Use these gestures to perform these actions: Table 2-1: Gestures and actions Gesture

Action

Swipe

Steer D-line (linear transducers only) Steer color box (linear transducers only) Scroll through pages in forms, such as the patient form, worksheets, and thumbnails in Review Select previous or next images in full-screen Review

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General interaction

Table 2-1: Gestures and actions (continued) Gesture

Action

Drag

Adjust depth or gain Move color or zoom box Move calipers Move D-line or M-line Move Doppler baseline With two or more fingers, drag anywhere on the touch panel to move or resize the active object, such as the Color box or the Doppler gate Move depth marker in biopsy guide Change the D-line angle selection Move labels, pictograms, and transducer marker Move through frames in the cine buffer Move controls to the Controls bar Pan a frozen zoomed 2D image (panning is disabled if measurements or labels exist on the frozen zoomed image) Unfreeze a frozen image by dragging the Slide to Unfreeze slider

Tap

Freeze Adjust depth Select calipers Select image in dual Select mode in split screen (2D, D-line, or Doppler trace)

Double-tap

With two or more fingers, double-tap to freeze or unfreeze Double-tap with one finger in the zoom box to zoom Double-tap with one finger on a live zoomed image to unzoom

Pinch or spread

Sample volume size Resize color or zoom box

General interaction

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