Titan User Guide P03322-08A Oct 2008

®

Ultrasound System User Guide

Manufactured by 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 SonoSite Ltd Alexander House 40A Wilbury Way Hitchin Herts SG4 OAP UK T: +44-1462-444800 F: +44-1462-444801 Caution:

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

SonoSite, SonoSite TITAN, and TITAN are trademarks of SonoSite, Inc. Kensington is a registered trademark of Kensington Technology Group. CompactFlash is a registered trademark of Symbol Technologies. Non-SonoSite product names may be trademarks or registered trademarks of their respective owners. The SonoSite product(s) referenced in this document may be covered by one or more of the following patents: 5722412, 5817024, 5893363, 6135961, 6203498, 6364839, 6371918, 6383139, 6416475, 6447451, 6471651, 6569101, 6648826, 6575908, 6604630, 6817982, 6835177, 6962566, 7169108, D456509, D461895, D509900, D538432, D544962, D558351, D559390. Patents pending. Other international patents may also apply.

P03322-08 08/2008 Copyright 2008 by SonoSite, Inc. All rights reserved. Printed in the USA.

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Contents Chapter 1: Introduction About the User Guide ...1 Conventions Used in This User Guide ...2 Symbols and Terms Used in This User Guide ...2 Upgrades and User Guide Updates ...2 Customer Comments ...2 About the System ...3 About the System Software ...5 Chapter 2: Getting Started Healthy Scanning Guidelines ...7 System Preparation ...10 Installing or Removing Battery ...10 Installing and Removing the CompactFlash Card ...11 Using AC Power/Charging Battery ...12 Turning System On/Off ...12 Connecting and Removing the Transducer ...13 System Controls ...14 Screen Layout ...16 General Interaction ...18 Touchpad ...18 Context Menus ...18 Remappable Controls ...19 Annotation and Text ...19 Forms ...21 System Setup ...21 Chapter 3: Imaging Patient Information ...41 Transducer, Exam Type, and Imaging Mode ...43 Transducer Preparation ...45 General Use ...45 Invasive Use ...46 Modes ...47 2D Imaging ...47 M Mode Imaging ...50 Color Doppler Imaging ...52 Pulsed Wave (PW) and Continuous Wave (CW) Doppler Imaging ...54 ECG Monitoring ...57 Annotation ...58 Biopsy ...59

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Image Storage ... 60 Save to CompactFlash ... 60 Print to Local Printer ... 60 Image Review ... 61 Patient List ... 61 Patient Images ... 62

Chapter 4: Measurements and Calculations Measurements ... 63 2D Measurements ... 63 M Mode Measurements ... 65 Doppler Measurements ... 68 Calculations ... 72 Percent Reduction Calculations ... 72 Volume Calculation ... 74 Volume Flow Calculation ... 76 Gyn Calculations ... 78 OB Calculations ... 81 Vascular Calculations ... 89 Cardiac Calculations ... 92 Patient Report ... 101 Chapter 5: DICOM Connectivity TITAN System Setup for DICOM ... 105 Ethernet Connection ... 105 DICOM Setting Backup ... 105 DICOM Configuration ... 106 Configuring Locations ... 106 Configuring Archivers ... 109 Configuring Printers ... 112 Configuring Worklist Servers ... 116 Configuring Procedures ... 119 Importing and Exporting Configurations ... 120 Reviewing the Network Log ... 121 DICOM Usage ... 122 DICOM Image Archive and Print ... 124 Patient Information ... 126 DICOM Worklists ... 127 Chapter 6: Safety Ergonomic Safety ... 129 Electrical Safety ... 129 Equipment Safety ... 131 Battery Safety ... 131 Biological Safety ... 132 Electromagnetic Compatibility (EMC) ... 133 Manufacturer’s Declaration ... 134

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The ALARA Principle ...137 Applying ALARA ...137 Direct Controls ...138 Indirect Controls ...138 Receiver Controls ...138 Output Display ...139 Related Guidance Documents ...140 Acoustic Output Measurement ...140 In Situ, Derated, and Water Value Intensities ...141 Tissue Models and Equipment Survey ...141 Intended Uses ...142 About the Acoustic Output Table ...144 Acoustic Output Tables ...146 Global Maximum Derated ISPTA and MI Values ...155 Acoustic Measurement Precision and Uncertainty ...157 Labeling Symbols ...158

Chapter 7: Troubleshooting and Maintenance Troubleshooting ...161 Software Licensing ...163 Obtaining a License Key ...169 Installing a License Key ...170 Maintenance ...171 Recommended Disinfectant ...171 Safety ...171 Cleaning and Disinfecting the Ultrasound System ...172 Cleaning and Disinfecting Transducers ...173 Sterilizable Transducers ...174 Cleaning and Disinfecting Transducer Cables ...175 Cleaning and Disinfecting the Battery ...176 Chapter 8: References Display Size ...189 Caliper Placement ...189 2D Measurements ...189 Sources of Measurement Errors ...191 Acquisition Error ...191 Algorithmic Error ...191 Terminology and Measurement Publications ...191 Cardiac References ...192 Obstetrical References ...196 Gestational Age Tables ...197 Growth Analysis Tables ...199 Ratio Calculations ...200 General References ...201

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Chapter 9: Specifications System Dimensions ... 203 Display Dimensions ... 203 Transducers ... 203 Imaging Modes ... 203 Applications ... 204 Image Storage ... 204 Accessories ... 204 Hardware, Software, and Documentation ... 204 Cables ... 205 Peripherals ... 205 Medical Grade ... 205 Non-Medical Grade ... 205 Temperature, Pressure, and Humidity Limits ... 205 Operating Limits: System ... 205 Shipping/Storage Limits: System without Battery ... 205 Operating Limits: Battery ... 205 Shipping/Storage Limits: Battery ... 205 Operating Limits: Transducer ... 206 Shipping/Storage Limits: Transducer ... 206 Electrical ... 206 Battery ... 206 Electromechanical Safety Standards ... 206 EMC Standards Classification ... 206 Airborne Equipment Standards ... 207 DICOM Standard ... 207 HIPAA Standard ... 207 Chapter 10: Glossary Terms ... 209 Acronyms ... 211 Index ... 217

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Chapter 1: Introduction Introduction

Please read the information in this user guide before using the TITAN® high-resolution ultrasound system. It applies to the ultrasound system, and transducers.

About the User Guide This user guide is a reference for using the ultrasound system. It is designed for a reader familiar with ultrasound techniques; it does not provide training in sonography or clinical practices. Before using the system, you must have ultrasound training. The user guide covers the preparation, use, and maintenance of the ultrasound system, transducers, and accessories. Refer to the manufacturers’ instructions for specific information about peripherals. The user guide includes a table of contents and an index to help you find the information that you need. The user guide is divided into the following chapters: Chapter 1

“Introduction”

Contains general information about the user guide and the system. Customer assistance information is also included.

Chapter 2

“Getting Started”

Contains information on healthy scanning practices, basic operation, and changing system settings.

Chapter 3

“Imaging”

Contains detailed information about preparing for the exam, entering patient information, adjusting imaging modes, annotating images, saving images and reviewing patient images.

Chapter 4

“Measurements and Calculations”

Contains information on performing measurements and calculations in the different imaging modes.

Chapter 5

“DICOM Connectivity”

Contains instructions for configuring and using DICOM.

Chapter 6

“Safety”

Contains information required by various regulatory agencies, including information about the ALARA (as low as reasonably achievable) principle, the output display standard, acoustic power and intensity tables, intended uses, and other safety information.

Chapter 7

“Troubleshooting and Maintenance”

Contains information to assist in the correction of problems with system operation. Also contains information about proper care of the system, transducers, and accessories.

Chapter 8

“References”

Contains information about measurement accuracy and the sources from which the system measurements and calculations are derived.

Chapter 1: Introduction

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Introduction

Chapter 9

“Specifications”

Contains system and accessory specifications and agency approvals. Specifications for recommended peripherals can be found in the manufacturers’ instructions.

Chapter 10

“Glossary”

Contains definitions of ultrasound system terms and features.

Conventions Used in This User Guide These conventions are used in this user guide: • A Warning describes precautions necessary to prevent injury or loss of life. • A Caution describes precautions necessary to protect the products. • When the steps in the operating instructions must be performed in a specific order, the steps are numbered. • Bulleted lists present information in list format, but they do not imply a sequence. • The system handle is on the front of the system, and the battery compartment is on the back of the system.

Symbols and Terms Used in This User Guide Symbols and terms used on the system, are explained in “Screen Layout” on page 16, Chapter 5, “DICOM Connectivity”and/or Chapter 10, “Glossary.”

Upgrades and User Guide Updates SonoSite may offer software upgrades, new features, and improvements to the system performance. User guide updates accompany the upgrade software and provide detailed information on the enhancements.

Customer Comments Questions and comments are encouraged. SonoSite is interested in your feedback regarding the system and the user guide. Please call SonoSite at 1-888-482-9449. If you are outside the USA, call the nearest SonoSite representative. You can also send electronic mail (e-mail) to SonoSite at the following address: [email protected].

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Chapter 1: Introduction

About the System Introduction

The ultrasound system has multiple configurations and feature sets. All are described in this user guide but not every option may apply to your system. System features are dependent on your system configuration, transducer, and exam type.

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1 2 5

3

Figure 1 TITAN System Front View Table 1: System Front Features Number

Feature

1

Control panel

2

Transducer connection

3

Handle

4

Display

5

CompactFlash™ slots (front for image storage, back for system and transducers updates, import/export OB tables, user names/passwords, and DICOM configurations)

Chapter 1: Introduction

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Introduction

1

2

3

4

Figure 2 TITAN System Back View Table 2: System Back Connectors Number

Feature

1

DC input connector

2

I/O connector

3

Battery

4

ECG connector

The TITAN system is a portable, software-controlled, ultrasound system using all-digital architecture. The system is used to acquire and display high-resolution, real-time ultrasound images: 2D, color power Doppler (CPD), directional color power Doppler (DCPD), Color Doppler (Color), Tissue Harmonic Imaging (THI), M Mode, pulsed wave (PW) Doppler, and continuous wave (CW) Doppler. The system has cine buffer, image zoom, labeling, biopsy, measurements, calculations, a USB connection for image transfer, image storage, image review, printing, recording, and the ability to archive Doppler with audio output to a videotape. Currently, the system supports the following broadband transducers: • C8/8-5 MHz 8 mm microcurved array • C11/8-5 MHz 11 mm microcurved array • C15/4-2 MHz 15 mm microcurved array • C60/5-2 MHz 60 mm curved array • HST/10-5 MHz 25 mm linear array • ICT/8-5 MHz 11 mm intracavitary array • L25/10-5 MHz 25mm linear array • L38/10-5 MHz 38 mm linear array System accessories include the following: TITAN mobile docking system, TITAN MDS Lite, TITAN mini-dock, Triple Transducer Connect, a power supply, a battery, ECG cable, video and printer cables, SiteLink Image Manager 2.2 software, and DICOM connectivity. See the TITAN Accessory User Guide for information on the accessories.

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Chapter 1: Introduction

Introduction

System peripherals include medical grade (conforming to the requirements of EN60601-1) and non-medical (commercial) grade products. System medical grade peripherals include a printer, VCR, and DVD. System non-medical grade peripherals include a CompactFlash card and a Kensington Security Cable. System setup instructions for the use of peripherals are covered in Chapter 2, “System Setup” on page 21. Manufacturer’s instructions accompany each peripheral. Instructions for the use of peripherals with the system are covered in the TITAN Accessory User Guide.

About the System Software The ultrasound system contains software that controls its operation. A software upgrade may be required. SonoSite will provide you with a CompactFlash card containing the software. Typically new software provides new capabilities. A single CompactFlash card can be used to update one or more systems. Software upgrades use the back CompactFlash slot on the right hand side of the system. CompactFlash cards installed in the front CompactFlash slot do not upgrade the system.

Chapter 1: Introduction

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Introduction

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Chapter 1: Introduction

Chapter 2: Getting Started

Healthy Scanning Guidelines These guidelines are intended to assist you in the comfort and effective use of your ultrasound system. Warning:

Getting Started

This chapter contains information on healthy scanning practices, basic operation, and changing system settings.

Use of an ultrasound system may be linked to musculoskeletal disordersa,b,c. Use of an ultrasound system is defined as the physical interaction between the operator, the ultrasound system, and transducer. When using an ultrasound system, as with many similar physical activities, you may experience occasional discomfort in your hands, fingers, arms, shoulders, eyes, back, or other parts of your body. However, if you experience symptoms such as constant or recurring discomfort, pain, throbbing, aching, tingling, numbness, burning sensation, or stiffness, do not ignore these warning signs. Promptly see a qualified health professional. Symptoms such as these can be linked with musculoskeletal disorders (MSDs). MSDs can be painful and may result in potentially disabling injuries to the nerves, muscles, tendons, or other parts of the body. Examples of MSDs include carpal tunnel syndrome and tendonitis. While researchers are not able to definitively answer many questions about MSDs, there is a general agreement that certain factors are associated with their occurrence including: preexisting medical and physical conditions, overall health, equipment and body position while doing work, frequency of work, duration of work, and other physical activities that may facilitate the onset of MSDsd. This chapter provides guidelines that may help you work more comfortably and may reduce your risk of MSDse,f.

a. Magnavita, N., L. Bevilacqua, P. Mirk, A. Fileni, and N. Castellino. “Work-related Musculoskeletal Complaints in Sonologists.” Occupational Environmental Medicine. 41:11 (1999), 981-988. b. Craig, M. “Sonography: An Occupational Hazard?” Journal of Diagnostic Medical Sonography. 3 (1985),121-125. c. Smith, C.S., G.W. Wolf, G. Y. Xie, and M. D. Smith. “Muscoskeletal Pain in Cardiac Ultrasonographers: Results of a Random Survey.” Journal of American Society of Echocardiography. (May1997), 357-362. d. Wihlidal, L.M. and S. Kumar. “An Injury Profile of Practicing Diagnostic Medical Sonographers in Alberta.” International Journal of Industrial Ergonomics. 19 (1997), 205-216. e. Habes, D.J. and S. Baron. “Health Hazard Report 99-0093-2749.” University of Medicine and Dentistry of New Jersey. (1999). f. Vanderpool, H.E., E.A. Friis, B.S. Smith, and K.L. Harms. “Prevalence of Carpal Tunnel Syndrome and Other Work-related Muscoskeletal Problems in Cardiac Sonographers.” Journal of Medicine. 35:6 (1993), 605-610.

Chapter 2: Getting Started

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Position the System To promote comfortable shoulder, arm and hand postures, consider the following: Getting Started

•

Use the TITAN mobile docking system to support the weight of the ultrasound system.

To minimize eye strain, consider the following: • •

When the exam/procedure allows, position the system within reach. Adjust the angle of the system/display to minimize glare from overhead or outside lighting.

To minimize neck strain, consider the following: •

If using a stand, adjust the stand height such that the display is at or slightly below eye level.

Position Yourself To support your back, consider the following: • • • •

Use a chair that has support for your lower back. Use a chair that adjusts to your work surface height and promotes a natural body posture. Use a chair that allows for quick height adjustments. Always sit or stand in an upright manner. Avoid bending or stooping.

To minimize reaching and twisting, consider the following: • • • • •

Use a bed which is height adjustable. Position the patient as close to you as possible. Face forward. Avoid twisting your head or body. Move your entire body front to back and position your scanning arm next to or slightly in front of you. Stand for difficult exams to minimize reaching.

To promote comfortable shoulder and arm postures for your scanning arm, consider the following: • • •

Keep your elbow close to your side. Relax your shoulders in a level position. Support your arm using a support cushion or pillow, or rest it on the bed.

To minimize neck bending and twisting, consider the following: • •

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Position the ultrasound system/display directly in front of you. Provide an auxiliary monitor for patient viewing.

Chapter 2: Getting Started

Go Lightly To promote comfortable hand, wrist, and finger postures for your scanning arm, consider the following: Hold the transducer lightly in your fingers. Minimize the pressure applied on the patient. Keep your wrist in a straight position.

Take Breaks Minimizing scanning time and taking breaks can be very effective in allowing your body to recover from physical activity, which can help you avoid any MSDs. Some ultrasound tasks may require longer or more frequent breaks. One way of taking a break is to stop and relax. However, simply changing tasks can help some muscle groups relax while others remain or become active.

Getting Started

• • •

To vary your daily activities, consider the following: • • •

Plan your work so there are breaks in between ultrasound exams. Work efficiently when performing an ultrasound exam by using the software and hardware features correctly. Learn more about these features in Chapter 3 of this guide. Keep moving. Avoid sustaining the same posture by varying your head, neck, body, arm, and leg positions.

Exercise Targeted exercises can strengthen muscle groups, which may help you avoid MSDs. Contact a qualified health professional to determine stretches and exercises that are right for you.

Chapter 2: Getting Started

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System Preparation

Getting Started

Installing or Removing Battery The battery comprises six lithium-ion cells plus electronics, a temperature sensor, and battery contacts. If the battery is being installed for the first time, it will need to be charged. Warning:

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

Locking levers

Figure 1 Insert Battery into System

To install the battery: 1 2 3 4

Turn the system upside down. Place the battery into the battery compartment, at a slight angle. See Figure 1. Slide the battery forward until it locks into place. Push down on the two locking levers to secure battery.

To remove battery: 1 2 3

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Push up on the two locking levers. Slide the battery back. Lift the battery from the compartment.

Chapter 2: Getting Started

Installing and Removing the CompactFlash Card Images are saved to a CompactFlash card and are organized in a patient list. The images in the patient list are organized alphabetically by the patient name and ID. Images are archived from the system to a PC using a USB or Ethernet connection. Images on the CompactFlash card cannot be read directly from a CompactFlash card reader.

Verify the ejector pin is fully pushed in. Insert the CompactFlash card into the front slot on the ultrasound system. See Figure 1 on page 3. The front slot is used to store images. The back slot is used to update systems/transducers and to import/export DICOM configuration information and OB Tables. The CompactFlash card is ready to use when the save icon and the image memory counter, showing the remaining available memory, are displayed on the screen. 1 2

Getting Started

To install the CompactFlash card:

To remove the CompactFlash card: Warning:

1 2 3 4 5

To prevent loss of data, loss of images, or damage to the CompactFlash card, turn the ultrasound system off before removing the CompactFlash card. When the CompactFlash card is removed before turning off the ultrasound system, the system must be restarted.

Turn off the ultrasound system before removing the card. Press the ejector pin in the front card slot to position it to the outside of the system. See Figure 1 on page 3. Press in the ejector pin to eject the CompactFlash card. Note: If the CompactFlash card does not eject properly, try a new card. Remove the card. Push in the ejector pin to avoid damaging the ejector pin.

Chapter 2: Getting Started

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Getting Started

Using AC Power/Charging Battery The battery charges when the system is connected to the AC power supply. If the system is off and connected to AC power, a completely discharged battery will fully charge in 2.5 to 3.5 hours. If the system is on and connected to AC power, a completely discharged battery will fully charge in 5 to 6 hours. The system can run on AC power and charge the battery in three ways. • Connected directly to the system • Connected to the mini-dock (See the TITAN Accessory User Guide.) • Connected to the docking system (See the TITAN Accessory User Guide.)

To operate the system using AC power (directly to system): Warning:

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

Caution:

Verify the hospital supply voltage corresponds to the power supply voltage range. See “Electrical” on page 206.

1 2

Connect the DC power cable from the power supply to the connector on the system. See Figure 2 on page 4. Connect the AC power cord to the power supply and connect to a hospital-grade electrical outlet.

Turning System On/Off To turn the system on/off: Caution:

1 2

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

Locate the Power key on the top left side of the system. See Figure 3 on page 14. Press the Power key once to turn on and once to turn off.

To wake up the system: To conserve battery life, the system is configured to go into sleep mode. The system goes into sleep mode when the lid is closed or if the system has not been touched for a preset amount of time. Press any key, touch the touchpad, or open the lid to wake up the system. To adjust the time for sleep delay, see “To set up Audio and Battery:” on page 28.

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Chapter 2: Getting Started

Connecting and Removing the Transducer The transducer connector can become hot during operation. This is normal. Operate the system in the docking system or on a flat, hard surface to allow air flow past the connector.

Caution:

The electrical contacts inside the system transducer connector may be damaged by foreign material. Keep foreign material out of the connector.

Getting Started

Warning:

Figure 2 Connect the Transducer

To connect the transducer: 1 2 3 4 5 6

Turn the system upside down (if not in docking system). Pull the transducer latch up and rotate it clockwise. Align the transducer connector with the connector on the bottom of the system. Insert the transducer connector into the system connector. Turn the latch counterclockwise. Press the latch down, securing the transducer connector to the system.

To remove the transducer: 1 2

Pull the latch up and rotate it clockwise. Pull the transducer connector away from the system.

Chapter 2: Getting Started

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