iViz User Guide Sept 2015

Contents Chapter 1: Introduction About the iViz User Guide ... 1 Document conventions ... 1 Getting help ... 2

Chapter 2: Getting Started About iViz ... 3 Intended use ... 3 Diagnostic ultrasound ... 3 Vital signs monitoring ... 4 Accessories and peripherals ... 4 Hardware features ... 5 General interaction ... 7 Using the touchscreen ... 7 Using gestures ... 8 Opening menus and tool drawers ... 9 Entering text ... 10 Put the system into the protective case ... 10 Plugging in a transducer ... 11 Installing the battery and charging iViz ... 11 Installing the battery ... 11 Charging the battery ... 12 Removing the battery ... 14 Turning iViz on and off ... 14 Turning on iViz ... 15 Turning off iViz ... 15 Putting the system into sleep mode ... 15

Chapter 3: Configuring iViz Configuring Android settings ... 17 Activating security settings ... 17 Connecting to a wireless network ... 17 Connecting to a Bluetooth device ... 18 Setting the date and time ... 18 Adjusting the volume ... 19 Adjusting the screen brightness ...19 Configuring sleep mode ... 20 Adding a wireless printer ... 20

i

Configuring iViz settings ...21 Opening the iViz Settings screen ...21 Configuring preferences ...21 Configuring OB measurements and calculations ...22 Configuring labels ...22 Setting up a DICOM profile ...24 Configuring patient search settings ...26 Configuring EMR settings and preferences ...26 Connecting to a separate display ...27

Chapter 4: Managing Patient Records About iViz studies ...29 Accessing patient information ...29 Searching for a patient record ...29 Managing studies ...31 Viewing scheduled studies ...31 Browsing scheduled studies ...31 Creating or updating a patient study ...32 Ending a study ...33 Sharing a study ...34 Managing reports ...35 Editing a report ...35 Printing a report ...36 Sharing a report ...36

Chapter 5: Performing an Exam Understanding optimal thermal performance ...37 Beginning an exam ...37 Understanding imaging modes ...38 Exam overview ...38 Choosing a transducer and exam type ...40 Reviewing patient information ...41 Scanning in 2D ...42 Scanning in color ...42 Switching between CVD and CPD ...44 Controlling color gain ...45 Adjusting scale ...46 Inverting the blood flow colors ...47 Filtering ...47 Controlling flow ...48 Scanning in M Mode ...48 Moving the M Line ...49 Updating in M Mode ...49 Changing the sweep speed ...49

ii

Setting the image orientation ... 50 Optimizing the image ... 51 Adjusting depth and gain ... 52 Adjusting depth ... 52 Adjusting gain ... 53 Controlling the dynamic range ... 54 Accessing guided protocols ... 55 Physical ... 55 eFAST ...56 FATE ... 56 RUSH ... 57

Chapter 6: Managing Images and Clips Freezing an image ... 59 Saving an image or a clip ... 60 Reviewing an image or clip ... 61 Zooming in and out of an image ... 61 Adding labels ... 61 Deleting images and clips ... 63 Sending and sharing images and clips ... 63

Chapter 7: Measurements and Calculations Taking measurements ... 65 Working with calipers ... 65 Viewing and deleting measurement results ... 66 Taking basic measurements ... 66 About calculations ... 69 Overview ... 69 Calculating volume ... 70 Exam-based calculations ... 72 Cardiac calculations ... 72 Obstetrics calculations ... 74 Abdomen and Lung calculations ... 77 Working with the Smartheart Pro device ... 77

Chapter 8: Measurement References Measurement accuracy ... 81 Measurement publications and terminology ... 83

Chapter 9: Troubleshooting and Maintenance Troubleshooting ... 93

iii

Common problems ...93 Understanding error messages. ...93 Troubleshooting connectivity problems ...96 DICOM common problems ...96 Maintenance ...98 Over the air upgrades ...98 iViz performance testing ...99 Overview ...99 Recommended test equipment ...99 Functional acceptance ...99 2D performance tests ... 100 Additional performance tests ... 103 M Mode imaging ... 103

Chapter 10: Cleaning and Disinfecting Cleaning and disinfecting the system and protective case ... 106 Cleaning and disinfecting the transducer ... 107 Determining the required cleaning and disinfection level ... 107 Level A: Intermediate-level disinfection (non-critical) ... 108 Level B: High-level disinfection (semi-critical) ... 112 Cleaning the iViz carry case ... 115 Storing ... 115 Transporting ... 115 Disposing of the system ... 115

Chapter 11: Safety Ergonomic safety ... 117 Minimize eye and neck strain ... 118 Support your back during an exam ... 118 Minimize reaching and twisting ... 118 Promote comfortable shoulder and arm postures ... 118 Employ comfortable postures ... 118 Use comfortable wrist and finger postures with transducers ... 119 Take breaks, exercise, and vary activities ... 119 System and transducer temperatures ... 120 Electrical safety ... 120 Electrical safety classification ... 122 Equipment safety ... 122 Battery safety ... 123 Clinical safety ... 125 Hazardous materials ... 125 Electromagnetic compatibility ... 126 Wireless transmission ... 127 Electrostatic discharge ... 128

iv

Separation distance ...129 Compatible accessories and peripherals ...129 Guidance and manufacturer’s declaration ...130 iViz labeling symbols ...137 Specifications ...139 Dimensions ...139 Environmental limits ...140 Electrical specifications ...140 Battery specifications ...141 Equipment specifications ...141 Standards ...141 Electrical safety standards ...141 EMC standards classification ...141 Acoustic standards ...142 Biocompatibility standards ...142 Airborne equipment standards ...142 DICOM standard ...142 Security and privacy standards ...142 Wireless standards ...142

Chapter 12: Acoustic Output ALARA principle ...145 Applying the ALARA principle ...145 Direct, indirect, and receiver controls ...146 Acoustic artifacts ...146 Guidelines for reducing MI and TI ...147 Output display ...148 MI and TI output display accuracy ...148 Factors that contribute to display uncertainty ...148 Related guidance documents ...149 Transducer surface temperature rise ...149 Acoustic output measurement ...150 Tissue models and equipment survey ...151 Acoustic output tables ...152 Acoustic measurement precision and uncertainty ...156 Terminology in acoustic output tables ...156 Glossary ...158 General terms ...158

Chapter 13: IT Network Functions ...161 Network for connecting the device ...161 Specifications for the connection ...161 Hardware specification ...161

v

Software specifications ... 161 Security ... 161 Data flow ... 162 IT network failure recovery measures ... 163

vi

Chapter 1: Introduction About the iViz User Guide The iViz User Guide provides information about configuring and using the iViz ultrasound system, including: Managing patient data Performing exams Taking measurements and calculations Cleaning and disinfecting The information and procedures in this user guide apply to the iViz system and its included accessories. Other accessories and third-party equipment are subject to their own instructions and restrictions. The iViz User Guide is intended for a user familiar with ultrasound. It does not provide training in sonography, ultrasound, or clinical practices. Before using iViz, you must complete such training.

Document conventions The document follows these conventions: A WARNING describes precautions necessary to prevent injury or loss of life. A Caution describes precautions necessary to protect the products. A Note provides supplemental information. Numbered and lettered steps must be performed in a specific order. Bulleted lists present information in list format but do not imply a sequence.

About the iViz User Guide

1

Getting help In addition to this user guide, the following resources are available: Instructional videos On-board help videos FUJIFILM SonoSite Technical Support:

2

Phone (U.S. or Canada)

877-657-8118

Phone (outside U.S. or Canada)

425-951-1330, or call your local representative

Fax

425-951-6700

Email

[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 6380-5581

About the iViz User Guide

Chapter 2: Getting Started Use this section to help familiarize yourself with the iViz system and its uses.

About iViz iViz is a portable, hand-held device that acquires and displays high-resolution, real-time ultrasound images. Features available on the system include: 2D scanning mode with color Doppler Measurement and calculation support Image labeling DICOM support EMR system integration On-board help videos

Intended use Diagnostic ultrasound The SonoSite iViz Ultrasound System is a general purpose ultrasound system and non-continuous patient monitoring platform intended for use in clinical care by qualified physicians and healthcare professionals for evaluation by ultrasound imaging and fluid flow analysis. In the ultrasound scanning application, the iViz system with an attached transducer obtains ultrasound images as described below. Abdominal imaging applications are designed to 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. Abdominal imaging can be used to evaluate and perform interventional abdominal procedures and evaluate the presence or absence of blood flow in abdominal organs. Cardiac imaging applications are designed to assess the pericardial effusion or cardiac tamponade possibility, cardiac valves, the great vessels, heart size, cardiac function, lung, and surrounding anatomical structures for the presence or absence of pathology. Obstetrical imaging applications are designed to assess the fetal anatomy, viability, estimated fetal weight, fetal heart rate, fetal position, gestational age, amniotic fluid, and surrounding anatomical structures for the presence or absence of pathology transabdominally.

About iViz

3

Color Power Doppler (CPD) and Color Velocity Doppler (CVD) imaging tools are intended to evaluate the blood flow of the fetus, placenta, umbilical cord, and surrounding maternal structures in all cases, including high-risk pregnancies. High-risk pregnancy indications include, but are not limited to, multiple pregnancies, fetal hydrops, placental abnormalities, maternal hypertension, diabetes, and lupus. CPD and color imaging tools are not intended as a sole means of diagnosis nor as a sole method of highrisk pregnancy screening.

Vital signs monitoring iViz is intended for use in vital signs monitoring of the human body in a non-continuous ECG monitoring application. iViz obtains an ECG report through interaction with the Smartheart Pro software application and wireless 12-lead Smartheart Pro device.

Accessories and peripherals Caution

Use only accessories and peripherals recommended by FUJIFILM SonoSite, including the power supply. Connection of accessories and peripherals not recommended by FUJIFILM SonoSite could result in electrical shock. Contact FUJIFILM SonoSite or your local representative for a list of accessories and peripherals available from or recommended by FUJIFILM SonoSite.

The iViz ultrasound system is designed to support a variety of accessories and peripherals, including: 2-in-1 micro USB flash drive (64 GB) Protective case with handle and kickstand iViz carry case Pelican case iViz batteries USB charger Battery bay charger with power supply Dual charging station To order accessories, or to find out if a specific piece of equipment is compatible with the iViz ultrasound system, contact FUJIFILM SonoSite or your FUJIFILM SonoSite representative. See “Getting help” on page 2.

4

Accessories and peripherals

Hardware features The front of the system is shown in Figure 2-1.

Figure 2-1 Front of the iViz ultrasound system 1

Volume up

6

Micro USB port

2

Volume down

7

Power on/off

3

Transducer socket

8

Power status LED

4

Audio out

9

Microphone

5

Micro HDMI port

10

Front camera

Hardware features

5

The back of the system is shown in Figure 2-2.

Figure 2-2 Back of the iViz ultrasound system

6

1

Battery bay

2

Camera and flash

3

Speaker

Hardware features

General interaction When you first turn on iViz, the Home screen displays, as shown in Figure 2-3.

Figure 2-3 iViz Home screen The system has three main modules that are accessible from the Home screen: Patient, Scan, and Learn. Patient - This module lets you search for a patient, view the scheduled list of patients, and select an iViz study. In addition, you can add and edit a patient form and view and share images and clips. Scan - This module is where you perform patient exams. Learn - This module contains general ultrasound training videos and iViz on-board help videos.

Using the touchscreen When scanning, the iViz touchscreen is divided into two main areas: the left side contains your controls, and the right side is the scan area, as shown in Figure 2-4.

General interaction

7

FREEZE

Patient: John Smith

SAVE

ID: 1234567890

P21v: Abdomen MI: 0.0 TI: 0.0

RES

PEN

C

DR: 0

COLOR

THI

Pen MHz 0.00

Orient

2D Dynamic Range

Opt 89% 13%  01/01/2015 09:15

Depth: 16.4cm

End Study

Figure 2-4 Touchscreen while in scan mode 1 Scan mode selector

7

Type of exam

2 Thumb-operated control wheel

8

Time, date, and percent charged

3 Freeze an image

9

Tool drawer handle

4 Capture an image or a clip

10

Scan area

5 Number of saved images and clips in this study

11

Android controls

6 Patient name and data (tap to go to Patient module)

12

End the study and return to patient record

The system is designed so that you can use one hand to hold the system and the other hand to hold the transducer. If you’re not scanning, you can always use two hands.

Using gestures You interact with the touchscreen the same as with many other touchscreen devices:

8

General interaction

Swipe - Move your finger quickly across the screen.

Drag - Move one or two fingers across the screen, usually to move an object from one location to another. Tap - Quickly touch the screen once. Press and hold - Touch your finger to the screen, and hold it there for about two seconds. Pinch or zoom - Slide two fingers together or apart on the screen.

The controls that appear on the wheel depend on the scan mode you've selected. The function of each control is discussed in detail in Chapter 5, “Performing an Exam.”

Opening menus and tool drawers You can access additional controls by opening menus and tool drawers.

This symbol indicates a drop-down menu. Tap or swipe this symbol to open the menu. For instance, the Exam Type menu allows you to choose between several preset exam types.

This symbol indicates a drawer that you can open. Swipe up on this symbol to open the tool drawer. The tool drawer contains additional options such as labels, measurements, and guided protocols.

General interaction

9

This symbol indicates the drawer that opens the cine buffer when you are taking measurements or adding labels. Slide the drawer to the right to display the cine buffer, and slide it to the left to close it.

Entering text When filling out forms in iViz, such as when you are updating patient records or configuring settings, you can enter text by tapping the text field you want to edit. An on-screen keyboard appears, as shown in Figure 2-5.

Figure 2-5 Use the keyboard to type information.

Put the system into the protective case Caution

iViz device emits RF emissions. While the system meets SAR standards, using the protective case is recommended to reduce RF exposure.

To put the system into the protective case 1 Insert the system into one end of the case. 2 Bring the opposite case ends over the system to hold it in place.

10

Put the system into the protective case

Plugging in a transducer  Insert the transducer connector into the bottom of the iViz system, with the transducer connector facing away from the other connectors, until you hear it click.

Installing the battery and charging iViz Installing the battery Note

Battery performance depends on numerous factors, such as the scanning modes used, battery age, and display brightness.

To install the battery WARNING

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

1 On the back of the iViz system, position the battery in the battery slot so that the beveled edge of the battery is nearest the side of the iViz system.

2 Press the battery firmly into the back of the iViz system until it locks in place.

Plugging in a transducer

11

Charging the battery WARNING

To avoid the risk of electrical shock, burn, or fire, use only the FUJIFILM SonoSite USB charger (P19927).

Cautions

The battery can be stored at temperatures between -20°C (-4°F) to 60°C (140°F). Charge batteries only when the ambient temperature is between 10°C (50°F) and 40°C (104°F). iViz will not operate without a battery installed, even if the USB charger is plugged in. Verify that the hospital supply voltage corresponds to the power supply voltage range. See “Electrical safety standards” on page 141. When the battery charge is low on your iViz system, you have the option of plugging the system in to recharge, or replacing the battery with a freshly charged one. To avoid risk from loss of power, plug the system into an appropriate power source or change batteries when the battery is low.

There are two ways to charge the iViz batteries; you can use the included battery charger or plug in the USB charger while a battery is installed in system. To charge the battery while it’s installed in the iViz system 1 Turn off the system. See “Turning off iViz” on page 15. 2 Connect the line cord of the USB power adapter to a hospital-grade electrical outlet.

12

Installing the battery and charging iViz

3 Connect the AC power adapter to the micro-USB power receptacle on the system.

Notes

iViz cannot perform scanning functions while the AC power adapter is attached to the system. Charging the battery this way may require more time than when using the battery charger. iViz is not provided with an AC mains power switch. To disconnect the equipment from the mains, unplug the DC adapter from the wall outlet.

4 When you are finished charging the battery, disconnect the system from AC power. 5 Turn the system on to check the battery charge. To charge the battery using the iViz battery charger 1 Connect the line cord of the AC power adapter to a hospital-grade electrical outlet. 2 Connect the AC power adapter to the receptacle on the battery charger. 3 Remove the battery from the iViz system, and insert it in a slot on the battery charger. You can charge up to two batteries at a time. Note

The optional iViz dual charging station allows you to charge up to four batteries at a time.

Installing the battery and charging iViz

13