Sonosite Edge User Manual

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:

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:97 113678.5; DE: 69831698.3; DE: 69830539.6; DE:

69730563.5; DE: 602004027882.3; DE: 60200402 3816.3; DE: 60034 670.6; DE: 60029 777.2; EP: 15898 78; EP: 1552792; E P: 1180971; EP: 0875203; EP: 0815793; EP 1180970; EP 0881492; ES: 2229318; ES: 159878; ES: 1552792; ES: 0881492; FR: 158978; FR: 155279 2; FR: 1180970; FR: 0881492; FR: 0875203; FR:0815793; GB: 158978; GB: 1552792; GB: 1 180 971; 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.

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



0086

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

iii

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

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

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

Glossary

Terms ....................................................................................................................................173

Abbreviations ...................................................................................................................175

Index ..................................................................................................................................185

vii

viii

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.

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

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

Chapter 7, and Glossary.

.

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):

Phone (Outside U.S. and Canada):

Fax: 425-951-6700

E-mail: service@sonosite.com

Web site: www.sonosite.com

Europe Service Center:

877-657-8118

425-951-1330 Or call your local representative.

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

x Customer comments

Chapter 1: Getting Started

23 4

About the system

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.

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.

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.)

Getting Started

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

3 Press the

information form.

4 Press an imaging mode key: 2

DOPPLER.

PATIENT key, and complete the patient

D, MMODE, COLOR,

Preparing the system

Installing or removing the battery

WARNING:

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.

See also “Battery safety” on page 100.

Chapter 1: Getting Started 1

To install the battery

1 Disconnect the power supply from the

ultrasound system.

To remove the battery

1 Disconnect the power supply from the

ultrasound system.

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.

4 Slide the battery forward until it locks into place.

5 Slide the two locking levers outward to secure

the battery.

2 Remove the system from the mini-dock

(if present) and turn it upside down.

3 Pull up the two locking levers.

4 Slide the battery back.

5 Lift the battery from the compartment.

Using AC power and charging the battery

Caution:

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.

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

WARNING:

Figure 3 Install the Battery

Caution:

2 Preparing the system

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.

Verify that the hospital supply voltage corresponds to the power supply voltage range. See

“Electrical specifications” on

page 118.

To operate the system using AC power

1 Connect the DC power cable from the power

supply to the connector on the system. See

Figure 2 on page 1.

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.

Connecting transducers

WARNING:

Caution:

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 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.

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

Getting Started

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 3

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

sure that the USB storage device you use does not have

password protection enabled. See also

“Troubleshooting”

USB storage devices. Make

on page 89.

WARNING:

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.

4 Preparing the system

Caution:

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.

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.

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.

Getting Started

Chapter 1: Getting Started 5

System controls

109

1 Control keys Adjust on-screen controls.

2 Alphanumeric keys Enters text and numbers.

3 Annotation keys See “Alphanumeric keyboard” on page 10.

4 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.

5 AUTO GAIN Adjusts gain automatically.

DEPTH UP,

Decreases and increases imaging depth.

DEPTH DOWN

7 ZOOM Magnifies the image 100%.

6 System controls

8SET

CALIPER

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

9 CALCS Turns the calculations menu on and off.

10 Touchpad Selects, adjusts, and moves items on-screen.

11 FREEZE Stops live imaging and displays a frozen image.

12 SAVE Saves an image to internal storage. If configured, also saves calculations

to the report. See “Presets setup” on page 22.

13 SAVE CALC

CLIP

A & B shortcut keys Keys that you can program to perform common tasks.

Imaging Modes

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

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.

16 UPDATE Toggles between dual and duplex screens and imaging modes in

M Mode and Doppler (for example, between D-line and Doppler spectral trace).

17 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.

Forms

Getting Started

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.

19 Power switch Turns system on and off.

Chapter 1: Getting Started 7

Screen layout

1 Mode Data Area Current imaging mode information (for example, Gen, Res, THI,

and PW).

2 Orientation Marker Indication for image orientation. In dual and duplex images, the

orientation marker is green on the active screen.

3 Text Text entered using keyboard.

4 Pictograph Pictograph to indicate anatomy and transducer position. You can select

anatomy and screen location.

5 Calculations Menu Contains available measurements.

6 Image Ultrasound image.

7 Measurement and

Current data on measurements and calculations.

Calculations Data Area

8 On-screen Controls Controls available in the current context.

9 Patient Header Header details such as current patient name, ID number, user, and

date/time. Specified on the display information setup page.

10 System Status Information on system status (for example, exam type, transducer,

AC connected, battery charging, and USB).

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

8 Screen layout

General interaction

Touchpad and cursor

Caution:

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 activate that field. Additionally, you can use the cursor to select check boxes and items in lists.

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

SELECT key to

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

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

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

SELECT key.

Getting Started

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 9

Annotation and text

56 8 97

Alphanumeric keyboard

1 TAB Moves cursor among fields in

the forms, and tabs between text position in dual screens.

CAPS LOCK

Sets the keyboard to capital letters.

7 SPACEBAR Turns the keyboard on for

text entry. In text entry, adds a space.

8 DELETE Removes all text from the

screen during text entry and when not measuring.

SHIFT Allows entry of capitalized

characters and international characters.

9Arrow

Keys

Move highlighted selection in calculations menu, move cursor one space when entering text, move caliper position, move cine buffer forward and backward, and move among pages in image review and reports.

TEXT Turns the keyboard on and

off for text entry.

10 BACKSPACE Removes the character left

of the cursor in text-entry mode.

PICTO Turns pictographs on and off. 11 ENTER Moves cursor among fields

in forms and saves calculations to report.

ARROW Displays an arrow graphic

that can be moved and rotated within the image area.

10 General interaction

Symbols

You can enter symbols and special characters in select fields and forms. The symbols and special characters available depend on context.

Patient information form: Last, First, Middle, Patient ID, Accession, Indications, Procedure ID, User, Reading Dr., Referring Dr., and Institution fields

DICOM or SiteLink configuration page: Alias and AE Title fields

A & B Key, Footswitch setup page: Text field

Text mode (imaging): Annotation field

Figure 6 Symbols Dialog Box

To enter symbols or special characters

1 Select the field, and then select Symbols.

2 Select the desired symbol or character.

Preparing transducers

WARNING:

Caution:

Some transducer sheaths contain natural rubber latex and talc, which can cause allergic reactions in some individuals. Refer to 21 CFR 801.437, User labeling for devices that contain natural rubber.

Some gels and sterilants can cause an allergic reaction on some individuals.

To avoid damage to the transducer, use only gels recommended by FUJIFILM SonoSite. Using gels other than the one recommended by FUJIFILM SonoSite can damage the transducer and void the warranty. If you have questions about gel compatibility, contact FUJIFILM SonoSite or your local representative.

FUJIFILM SonoSite recommends that you clean transducers after each use. See “Cleaning and

disinfecting transducers” on

page 92.

Getting Started

You can also press the keys on the keyboard.

3 Select OK.

Acoustic coupling gel must be used during exams. Although most gels provide suitable acoustic coupling, some gels are incompatible with some transducer materials. FUJIFILM SonoSite recommends Aquasonic with the system.

For general use, apply a liberal amount of gel between the transducer and the body. For invasive or surgical use, apply a transducer sheath.

gel and provides a sample

Chapter 1: Getting Started 11

4 Select the Videos tab.

WARNING:

To prevent contamination, the use of sterile transducer sheaths and sterile coupling gel is recommended for clinical applications of an invasive or surgical nature. Do not apply the transducer sheath and gel until you are ready to perform the procedure.

To apply a transducer sheath

FUJIFILM SonoSite recommends the use of market-cleared, transducer sheaths for intracavitary or surgical applications.To lessen the risk of contamination, apply the sheath only when you are ready to perform the procedure.

1 Place gel inside the sheath.

2 Insert the transducer into the sheath.

3 Pull the sheath over the transducer and cable

until the sheath is fully extended.

4 Secure the sheath using the bands supplied

with the sheath.

5 Check for and eliminate bubbles between the

face of the transducer and the sheath.

Bubbles between the face of the transducer and the sheath may affect the ultrasound image.

6 Inspect the sheath to ensure that there are no

holes or tears.

5 If the list does not appear, select the correct USB

device:

a Select Select USB.

b In the Select USB device for media

playback dialog box, select the Education

Key USB device (“Training” appears under Type), and then select Select.

Note: Image Gallery is an unsupported feature.

To view a video

1 Display the list of videos.

2 Select the video.

3 Select View on-screen.

The video begins playing.

4 Select any of the following, as needed:

• Adjusts the volume. The higher the number, the louder the sound. Zero is mute.

• Back Rewinds the video 10 seconds.

• Pause Pauses the video.

• Play Resumes playing of a paused video.

• Forward Advances the video 10 seconds.

To exit a video

 Select one of the following:

• List to return to the video list.

• Done to return to 2D imaging.

Training videos

The SonoSite® Education Key™ training videos are an optional feature.

To display the list of videos

1 Insert the Education Key USB device into a USB

port on the system.

2 Press the

3 If there is an active exam, select List on-screen.

12 Training videos

REVIEW key.

Intended uses

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 listed below.

For the intended transducer and imaging modes for each exam type, see “Imaging modes and exams

available by transducer” on page 33.

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, cardiac valves, great vessels, surrounding anatomical structures, overall cardiac performance, and heart size for the presence or absence of pathology.

In addition, you can identify the presence and location of fluid around the heart and lungs, use to assist in pericardiocentesis and thoracentesis procedures, visualize blood flow through cardiac valves, and detect normal lung motion for the presence or absence of pathology.

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

WARNING:

The ECG is not used to diagnose cardiac arrhythmias and is not designed for long term cardiac rhythm monitoring.

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, spinal nerve blocks and taps, 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.

WARNING:

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).

Getting Started

Chapter 1: Getting Started 13

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.

Superficial Imaging Applications You can assess the breast, thyroid, testicle, lymph nodes, hernias, musculoskeletal structures, soft tissue structures, ophthalmic structures, and surrounding anatomical structures for the presence or absence of pathology. You can use the system for ultrasound guidance in biopsy and drainage procedures, vascular line placement, peripheral nerve blocks, and spinal nerve blocks and taps.

Vascular Imaging Applications You can assess the carotid arteries, deep veins, and arteries in the arms and legs, superficial veins in the arms and legs, great vessels in the abdomen, and various small vessels feeding organs for the presence or absence of pathology.

WARNING:

To avoid injury to the patient, use only an Orbital (Orb) or Ophthalmic (Oph) exam type when performing imaging through the eye. The FDA has established lower acoustic energy limits for ophthalmic use. The system will not exceed these limits only if the Orb or Oph exam type is selected.

Transcranial Imaging Applications You can assess the anatomical structures and vascular anatomy of the brain for presence or absence of pathology. You can use imaging temporally, trans-occipitally, or trans-orbitally.

WARNING:

14 Intended uses

Chapter 2: System Setup

The system setup pages let you customize the system and set preferences.

Displaying the setup pages

To display a setup page

1 Press the SETUP key.

2 Select the setup page under Setup Pages.

To return to imaging from a setup page, select

Done on-screen.

Restoring default settings

To restore default settings for a setup page

 On the setup page, select Reset on-screen.

To restore all default settings

1 Turn the system off.

2 Connect the system to AC power. (See “To

operate the system using AC power” on

page 3.)

3 Simultaneously press 1 and the power key.

The system beeps several times.

A & B Key, Footswitch setup

Footswitch (L), Footswitch (R) The function of the left and right footswitches: Save Clip, Freeze, Save Image, or Print. See also “To connect the

footswitch.”

To connect the footswitch

The FUJIFILM SonoSite footswitch allows hands-free operation with a customizable two-pedal footswitch. The footswitch is an optional feature.

WARNING:

1 Connect the footswitch USB cable to the USB

port on the system or mini-dock.

2 On the A & B Key, Footswitch setup page, select

a function for the left and right footswitches.

To avoid contamination, do not use the footswitch in a sterile environment. The footswitch is not sterilized.

Administration setup

On the Administration setup page, you can configure the system to require users to log in and enter passwords. Required login helps protect patient data. You can also add and delete users, change passwords, import and export user accounts, and view the event log.

Setup

On the A & B Key, Footswitch setup page, you can program the shortcut keys and footswitch to perform common tasks. Select from the following lists:

A Key, B Key The function of the shortcut keys. By default, the A shortcut key is set to Print and the B shortcut key is set to none. The shortcut keys are below the alphanumeric keypad.

Chapter 2: System Setup 15

Security settings

WARNING:

Health care providers who maintain or transmit health information are required by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the European Union Data Protection Directive (95/46/EC) to implement appropriate procedures: to ensure the integrity and confidentiality of information; to protect against any reasonably anticipated threats or hazards to the security or integrity of the information or unauthorized uses or disclosures of the information.

2 In the User Login list, select On.

• On requires a user name and password at startup.

• Off allows access to the system without a user name and password.

To change the administrator password or let users change passwords

1 Log in as Administrator.

2 Under User List, select Administrator.

3 Do any of the following:

• Change the administrator password: Under User Information, type the new password in the Password box and Confirm box. (See “Choosing a secure password” on page 18.)

Security settings on the system allow you to meet the applicable security requirements listed in the HIPAA standard. Users are ultimately responsible for ensuring the security and protection of all electronic protected health information collected, stored, reviewed, and transmitted on the system.

To log in as Administrator

1 On the Administration setup page, type

Administrator in the Name box.

2 Type the administrator password in the

Password box.

If you don’t have the administrator password, contact FUJIFILM SonoSite. (See “FUJIFILM

SonoSite Technical Support” on page ix.)

3 Select Login.

To log out as Administrator

 Turn off or restart the system.

To require user login

You can set the system to display the User Login screen at startup.

1 Log in as Administrator.

• Let users change their passwords: Select the Password changes check box.

4 Select Save.

User setup

To add a new user

1 Log in as Administrator.

2 Select New.

3 Under User Information, fill in the Name,

Password, and Confirm boxes. (See

“Choosing a secure password” on page 18.)

4 (Optional) In the User box, type the user’s

initials to display them in the patient header and the User field in the patient information form.

5 (Optional) Select the Administration Access

check box to allow access to all administration privileges.

6 Select Save.

To modify user information

1 Log in as Administrator.

2 Under User List, select the user.

16 Administration setup

3 Under User Information, make changes as

desired.

4 Select Save.

3 Select Import on-screen.

4 Select the USB storage device, and select

Import.

Any change to the user name replaces the previous name.

To delete a user

1 Log in as Administrator.

2 Under User List, select the user.

3 Select Delete.

4 Select Yes.

To change a user password

1 Log in as Administrator.

2 In the User List, select the user.

3 Type the new password in the Password box

and Confirm box.

4 Select Save.

Exporting or importing user accounts

The export and import commands let you configure multiple systems and back up user account information.

To export user accounts

1 Insert a USB storage device.

2 Log in as Administrator.

3 Select Export on-screen. A list of USB devices

appears.

4 Select the USB storage device, and select

Export.

All user names and passwords are copied to the USB storage device. Passwords are encrypted.

To import user accounts

1 Insert the USB storage device that contains the

accounts.

5 Restart the system.

All user names and passwords on the system are replaced with the imported data.

Exporting and clearing the Event log

The Event log collects errors and events and can be exported to a USB storage device and read on a PC.

To display the Event log

1 Log in as Administrator.

2 Select Log on-screen.

The Event log appears.

To return to the previous screen, select Back.

To export the Event log

The Event log and the DICOM network log have the same file name (log.txt). Exporting either one to a USB storage device overwrites any existing log.txt file.

1 Insert a USB storage device.

2 Select Log and then select Export on-screen.

A list of USB devices appears.

3 Select the USB storage device, and select

Export.

The Event log is a text file that you can open in a text-editing application (for example, Microsoft Word or Notepad).

To clear the Event log

1 Display the Event log.

2 Select Clear on-screen.

3 Select Yes.

Setup

2 Log in as Administrator.

Chapter 2: System Setup 17

Logging in as user

If user login is required, the User Login screen appears when you turn on the system. (See “To

require user login” on page 16.)

To log in as user

1 Turn on the system.

2 In the User Login screen, type your name and

password, and select OK.

To log in as guest

Guests can scan but can’t access system setup and patient information.

1 Turn on the system.

2 In the User Login screen, select Guest.

To change your password

1 Turn on the system.

2 In the User Login screen, select Password.

3 Type your old and new passwords, confirm the

new password, and then select OK.

Choosing a secure password

To ensure security, choose a password that contains uppercase characters (A-Z), lowercase characters (a-z), and numbers (0-9). Passwords are case-sensitive.

Annotations setup

On the Annotations setup page, you can customize predefined labels and set the preference for managing text when unfreezing images.

1 In the Exam list on the Annotations setup page,

select the exam type whose labels you want to specify.

2 For Group, select A, B, or C for the label group

you want associated with that exam.

The preset labels appear for the selected group.

3 Do any of the following:

• Add a custom label to the group: Type the label in the Text box, and select Add.

• Rename a label: Select the label, type the new name in the Text box, and select Rename.

• Move a label within the group: Select the label, and then select the on-screen up or down arrow.

• Delete a label from a group: Select the label, and select Delete.

You can use symbols in labels. See “Symbols” on page 11.

To specify text retention when unfreezing

You can specify which text to keep when you unfreeze an image or change the imaging layout.

 In the Unfreeze list on the Annotations setup

page, select Keep All Text, Keep Home Text, or Clear All Text.

The default setting is Keep All Text. For information on setting the home position, see

“To reset the home position” on page 36.

To export predefined label groups

1 Insert a USB storage device.

For instructions to annotate images, see

“Annotating images” on page 35.

To predefine a label group

You can specify which labels are available for an exam type when annotating an image. (See “To

place text on an image” on page 35.)

18 Annotations setup

2 On the Annotations setup page, select Export.

A list of USB devices appears.

3 Select the USB storage device, and select

Export.

A copy of all predefined label groups for all exams saves to the USB storage device.

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