SonoSite 180 User Guide P02614-03A

SonoSite 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 0AP UK T: +44-1462-444800 F: +44-1462-444801 Caution:

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

SiteCharge, SitePack, SiteStand, and SonoHeart are registered trademarks or trademarks of SonoSite, Inc. Non-SonoSite product names may be trademarks or registered trademarks of their respective owners. Protected by U.S. patents: 5722412, 5817024, 5893363, 6135961, 6364839, 6371918, 6383139, 6416475, 6447451, 6471651, 6648826, 6569101, 6604630, 6962566, D456509, D461895. Patents pending.

P02614-03 05/2007 Copyright 2007 by SonoSite, Inc. All rights reserved. Printed in the USA.

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Contents Chapter 1: Introduction About the User Guide ...1 Conventions ...1 Symbols and Terms ...1 Upgrades and User Guide Updates ...1 Customer Comments ...1 About the System ...2 Conventions Used on System ...2 About the System Software ...5 Software Licensing ...5 Chapter 2: Preparing the System Connecting and Removing Transducers ...7 Turning the System On or Off ...8 Installing and Removing Battery ...9 Using AC Power ...10 Upgrading the System Software ...10 Obtaining a License Key ...11 Installing a License Key ...12 Checking and Charging the Battery ...14 Using the SiteCharge® Dual Battery Charger ...16 Using System Setup ...17 Using the SiteStand® Mobile Docking Station ...23 Using Software ...23 SiteLink Image Manager ...23 IrfanView Software ...24 Chapter 3: Imaging Preparing for the Exam ...25 Transducer, Exam Type, and Imaging Mode ...26 2D Imaging ...28 M-mode Imaging ...30 Color Power Doppler (CPD) or Directional Color Power Doppler (DCPD) Imaging ...32 Pulsed Wave (PW) and Continuous Wave (CW) Doppler Imaging 33 ECG Monitoring ...36 Annotating Images ...37 Needle Guidance ...40 Printing Images ...40 Saving and Reviewing Images ...41 Recording Images ...42 After the Exam ...42

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Chapter 4: Measurements and Calculations Measurements ... 43 2D Measurements ... 43 M-mode Measurements ... 44 Doppler Measurements–Pulsed Wave (PW) and Continuous Wave (CW) ... 45 Calculations ... 50 Volume Calculation ... 50 Volume Flow Calculation ... 52 OB Calculations ... 54 Vascular Calculations ... 57 Cardiac Calculations ... 59 Viewing Patient Report ... 69 Chapter 5: Safety Electrical Safety ... 71 Equipment Protection ... 73 Battery Safety ... 73 Biological Safety ... 74 Electromagnetic Compatibility (EMC) ... 75 Manufacturer’s Declaration ... 76 The ALARA Principle ... 79 Applying ALARA ... 79 Direct Controls ... 80 Indirect Controls ... 80 Receiver Controls ... 80 Output Display ... 80 Related Guidance Documents ... 81 Acoustic Output Measurement ... 81 In Situ, Derated, and Water Value Intensities ... 81 Tissue Models and Equipment Survey ... 82 Intended Uses ... 83 About the Acoustic Output Table ... 85 Acoustic Output Tables ... 87 Global Maximum Derated ISPTA and MI Values ... 95 Acoustic Measurement Precision and Uncertainty ... 97 Labeling Symbols ... 98 Chapter 6: Troubleshooting and Maintenance Troubleshooting ... 101 Maintenance ... 103 Recommended Disinfectant ... 103 Safety ... 103 Cleaning and Disinfecting the Ultrasound System ... 104 Cleaning and Disinfecting Transducers ... 105 Cleaning and Disinfecting the ECG Cables ... 107 Sterilizing Transducers ... 107 Cleaning and Disinfecting Transducer Cables ... 107

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Chapter 7: References Measurement Accuracy ...123 Display Size ...123 Caliper Placement ...123 2D Measurements and Calculations ...123 Sources of Measurement Errors ...125 Acquisition Error ...125 Algorithmic Error ...125 Terminology and Measurement Publications ...125 Cardiac References ...126 Obstetrical References ...129 General References ...132 Chapter 8: Specifications Physical Dimensions ...135 Monitor ...135 Transducers ...135 Imaging Modes ...135 Applications ...136 Display Elements ...136 Ultrasound System Controls ...137 Measurements and Calculations ...137 2D ...137 M-mode ...137 PW and CW Doppler Mode ...137 Volume ...137 Volume Flow ...138 Cardiac Calculations ...138 Obstetrical Calculations ...139 Fetal Tables ...140 Vascular ...140 Image Storage ...140 Accessories ...141 Peripherals ...142 Medical Grade ...142 Non-medical Grade (Commercial) ...142 Temperature, Pressure, and Humidity Limits ...142 System Operating ...142 System Shipping/Storage ...142 Battery Operating ...142 Battery Shipping/Storage ...142 Transducers Operating ...142 Transducers Shipping/Storage ...143

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Electrical ... 143 Battery ... 143 Electromechanical Safety Standards ... 143 EMC Standards Classification ... 144 Airborne Equipment Standards (without ECG Cable attached) ... 144 ECG Standard ... 144

Chapter 9: Glossary Symbols ... 145 Icons ... 146 Terms ... 150 Acronyms ... 160 Index ... 165

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Chapter 1: Introduction Introduction

Please read the information in this user guide before using the ultrasound system. It applies to the ultrasound system, transducers, accessories, and peripherals.

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. See the manufacturers’ instructions for specific information about peripherals.

Conventions 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. • Numbered steps in the operating instructions must be performed in a specific order. • Bulleted lists present information in list format, but they do not imply a sequence. • The left side of the system is to your left as you face the system. The system handle is at the top of the system, the battery compartment is at the bottom of the system.

Symbols and Terms Symbols and terms used on the system, are explained in, Chapter 5, “Safety”and/or Chapter 9, “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].

Chapter 1: Introduction

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Introduction

About the System The SonoSite system has various configurations and features. All are described in this manual but not every option may apply to your system. System features are dependent on your system configuration, transducer and exam type. The SonoSite system is a portable, software-controlled, ultrasound system. It has an all-digital architecture. It is used to acquire and display high-resolution, real-time, 2D, color power Doppler (CPD), directional color power Doppler (DCPD), Tissue Harmonic Imaging (THI), M-mode, pulsed wave (PW) Doppler, and continuous wave (CW) Doppler ultrasound images. The system has electrocardiography (ECG), cine review, image zoom, labeling, biopsy, measurements and calculations, serial connection for image transfer, image storage and review, printing and recording with the capability of archiving Doppler with audio output to a videotape. The system setup also has a selection to support optical character recognition (OCR) of the English character set for time, date, patient name, and patient identification. The OCR screen characters are optimized for use with the ALI NewPORT DICOM image capture station peripheral available from ALI. For more information about the ALI NewPORT 2.1, see the ALI NewPORT 2.1 Image Capture Station User’s Guide. Currently, the system supports the following transducers: • C8/8-5 MHz 8-mm microcurved array • C11/7-4 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/7-4 MHz 11-mm intracavitary array • L25/10-5 MHz 25 mm linear array • L38/10-5 MHz 38-mm linear array System accessories include a SiteStand® mobile docking station, flat panel display, VCR bracket for SiteStand, SiteCharge® dual battery charger, a power adapter, a battery, ECG cable, video and printer cables, audio cable, SiteLink image manager software, Basic Stand, CRT Stand, ScanPack quick access carrier, Grab and Go Carrying Case, and SitePack® protective carry pack. System peripherals include medical grade (conforming to the requirements of EN60601-1) and non-medical (commercial) grade products. System medical grade peripherals include an external color monitor, video printers, and VCR. System non-medical grade peripherals include a digital video recorder, a battery charger, a lithium-ion battery, printer, and a handheld monitor. Use of peripherals is covered in the manufacturers’ instructions, which accompany each peripheral. System setup instructions for the use of peripherals are covered in “Using System Setup” on page 17.

Conventions Used on System The software that runs the system uses graphic display elements similar to those used in many personal computers. System symbols and terms are explained in the “Glossary”. If a menu item or icon is selectable, then the menu item or icon is light gray. If a menu item or icon is not selectable, then the menu item or icon is dark gray. The active menu item or icon is green.

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Chapter 1: Introduction

The following figure and table describe the system controls.

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Introduction

1

2 11

Rear view

3 12 4

13

5

6 7 8

14 15 16 17

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Number

Feature

1

Power switch, located on the rear of the system handle

2

Near, affects gain of shallow echoes

3

Far, affects gain of deeper echoes

4

Gain, affects overall gain

5

Menu select controls

6

Menu, Depth, and Zoom

7

Trackball

8

Patient

9

Function key

10

Battery charge indicators

Chapter 1: Introduction

3

Introduction

Number

Feature

11

LCD (liquid crystal display) brightness control

12

LCD contrast control

13

LCD

14

Print/VCR or Print key

15

Cine Arrow keys and Freeze key

16

Mode controls

17

Battery release

The following figure shows the display and the layout of the screen: Patient name

Patient ID

Picto Scale

Scale Text Annotation

Exam type Menu select

Transducer

Measurements/ menu labels

Reference image/mode Optimization/angle correct

Menu icons

MI/TI Working/print/record

Menu labels

Battery/AC plug Image memory

ECG trace

Depth

Message line 1 (calc results) Message line 2 (calc measurements)

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Chapter 1: Introduction

Date

Time

About the System Software Introduction

Your SonoSite system contains software that controls its operation. From time to time, SonoSite may provide new software for use with your system. This software is provided using a software update module or a transducer. This software is either required or optional. A single module or transducer can be used to update one or more systems. When the new software is required, you must install it if you wish to use the new software features (e.g., new transducer). If you choose not to install it, you must remove the transducer and replace it with one that is compatible with the software that is currently installed in your system. When the software is optional, you can either install it or choose to use your existing software. If you choose not to install the software, the system will prompt you again whenever the system is started, and whenever the transducer is disconnected and then reconnected to the system. See “Upgrading the System Software” on page 10 for more information on software upgrades.

Software Licensing Use of the software that you receive from SonoSite is controlled by a license key. A license key is a number sequence containing exactly 12 decimal digits. License keys are obtained from SonoSite or from its authorized representatives. You must obtain one key for each system that will use the new software. See “Obtaining a License Key” on page 11 for information on obtaining a license key. Software that you receive from SonoSite may be installed and will operate for a short period of time without requiring a valid license key. We refer to this period of time as the “grace period.” The grace period is variable. When you first install your software, your SonoSite system will prompt you for a license key. If you have not yet obtained a valid license key, you can elect to use the software as long as the grace period time has not been fully consumed. We refer to this mode of operation as “running in the grace period.” When a system is running in the grace period, all system functions are available. As you use the system, the grace period is slowly consumed. When the grace period has expired, the system will not be usable until a valid license key has been entered. Grace period time is not consumed while the system is powered off or when it is in “sleep” mode. Whenever a system is running in the grace period, the grace period time remaining is available on the license update screen. For information on displaying this screen, see “Installing a License Key” on page 12“. Caution:

When the grace period expires, all system functions except for licensing will become unavailable until a valid license key is entered into the system.

Chapter 1: Introduction

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Introduction

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Chapter 1: Introduction

Chapter 2: Preparing the System Connecting and Removing Transducers

Warning:

The transducer connector can become hot during operation. This is normal. Operate the system in the SiteStand mobile docking station 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 or by rough handling. Do not touch the electrical contacts. Keep foreign material out of the connector. Keep a transducer connected to the system whenever possible.

Transducer connector

Preparing System

Note: Only one transducer can be connected to the system at a time.

Transducer connector latch

Chapter 2: Preparing the System

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To connect the transducer:

Preparing System

1 2

3 4

On the transducer connector, pull the latch up and rotate it clockwise until it snaps to a stop. The latch should be easy to move. Do not force the latch. Align the transducer connector with the connector on the rear of the system and insert it by pushing the transducer connector into the system connector. The transducer connector should be easy to insert. Do not force the transducer connector. Turn the latch counterclockwise until it snaps to a stop. Press the latch down until it snaps into place, securing the transducer connector to the system.

To remove the transducer: 1 2

On the transducer connector, pull the latch up and rotate it clockwise until it snaps to a stop. Carefully pull the transducer connector away from the system.

Turning the System On or Off When turning power on or off, you must push and hold the Power switch for approximately one second before the system responds. This feature prevents battery discharge, resulting from accidentally turning the system on. It also prevents accidentally turning the system off during an exam. The first time you turn on the system, set the date and time. See “To set the date and time:” on page 57. Caution:

Do not use the system if an error message appears on the image display. Note the error code. Call SonoSite or your local representative. When an error code occurs, turn off the system by pressing and holding the power switch until the system powers down.

To turn power on/off: 1 2 3

Locate the Power switch on the back of the left side of the system handle. See the System Controls photograph in Chapter 1 on page 1. Press and hold the Power switch until the system beeps (approximately one second). Release the Power switch.

To wake up the system: The system has a sleep delay, which is activated through the sleep delay system setup. When the battery charge indicators are blinking, but the other system lighting is off, press any key to wake up the system.

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Chapter 2: Preparing the System

Installing and Removing Battery The battery comprises six lithium-ion cells (two sets of three connected in series) plus electronics, a temperature sensor, and the battery contacts. When in use, it is inserted into the system. If you are holding the system, when you remove the battery, place your hand beneath the battery. If it falls to the floor, it could be damaged, or cause personal injury.

If the battery is being installed for the first time, it will need to be charged. See “Checking and Charging the Battery” on page 14. Make sure to remove the protective tape from the battery contacts before charging the battery.

Preparing System

Warning:

To install the battery: 1 2

Locate the battery compartment at the bottom of the system. To install a new battery (label side up) into the battery compartment, push it into the compartment until both sides click into place. (Do not force the battery into the compartment, check the battery orientation if the battery is difficult to install.) Ensure that both sides of the battery are fully connected and that the battery release button is not pressed.

To remove the battery: 1 2

Turn off the system. Locate the battery compartment at the bottom of the system.

Warning:

3

If you are holding the system, when you remove the battery, place your hand beneath the battery. If it falls to the floor, it could be damaged, or cause personal injury.

To release the battery, press the battery release button (lower, right side) on the system.

Chapter 2: Preparing the System

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Using AC Power

Preparing System

The battery charges when the system is using AC power. If the system is off and connected to AC power, a fully discharged battery will charge in about three hours.

To operate the system using AC power: 1 2 3

Connect the AC line cord of the AC power adapter to a hospital-grade electrical outlet. Connect the DC line cord of the AC power adapter to the power connector on the system. See arrow labeled 1 in the figure below. Connect the AC power adapter to the system using the upper, left connector on the left side of the system. See Table 1, “System Connectors” on page 15 for placement of connectors.

Upgrading the System Software As described in Chapter 1, “Introduction”, on page 1, transducers that you receive from SonoSite may contain either required or optional upgrades to the system software that resides on your SonoSite system. Whenever you connect a transducer to a SonoSite system, the system communicates with the transducer to determine if it contains software that would upgrade the system. Caution:

Initiating any upgrade of the system software erases any images stored on your system. Do not upgrade the system software until you have determined that any stored images are no longer needed.

To upgrade the system software: 1

When you first connect a transducer with new software and turn the system on, the following message is displayed: Do you want to upgrade the system software?

2

For required upgrades: You must either perform the upgrade or replace the transducer with one that is compatible with the software currently installed on your system. Do one of the following: • Select no (disconnect transducer) to reject the system software upgrade. • Select yes (up to 20 minutes) to accept the system software upgrade and go to step 2. For optional upgrades: You may either install the new software or continue to use the existing software. SonoSite recommends that you install these optional upgrades soon after receiving them. Do one of the following: • Select no (continue) to use the system without upgrading. • Select yes (up to 20 minutes) to accept the upgrade and go to step 2. When you have accepted the upgrade, the system loads the new software and displays the following message: Upgrade in progress (20 minutes total).

Note: The system upgrade can take up to 20 minutes; however, many software upgrades will be completed in less time.

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Chapter 2: Preparing the System

To cancel the upgrade in progress, select cancel. If this is a required upgrade: • The existing software remains installed. • The system displays the following message: Incompatible transducer, upgrade the system software.

Successful upgrade.

4

If the software upgrade is unsuccessful, the system displays an error code and you must contact SonoSite technical support at 1-877-657-8118. Select reboot to restart your system. During the restart, the initial system screen shows two progress indicator bars. These progress indicator bars are present while the system is replacing its operating software and disappear when the process is completed. When the operating software has been replaced, the system presents you with the license update screen so that you may license the software. At this point, the software upgrade process is complete, but the system software is not yet licensed. The following section explains how to license your software.

Preparing System

3

If this is an optional upgrade: • The existing software remains installed. • The system will go to live scan. When the system has loaded the new software, the following message is displayed:

Obtaining a License Key A license key is required to update your SonoSite system. It may be obtained by doing one of the following: If you encounter difficulty with the system, use the information in this chapter to help correct the problem. If the problem is not covered here, call SonoSite technical support at the following numbers or addresses:

Technical support

1-877-657-8118

International technical support:

Contact your local representative or call 425-951-1330

Technical support fax:

1-425-951-6700

Technical support e-mail:

[email protected]

SonoSite website:

www.sonosite.com and select Products & Solutions and then Technical Support

To receive your license key, you will need to provide the following information, which is displayed on the system information screen of your system (except for the person installing the upgrade and the system serial number): • Name of the person installing the upgrade • System serial number (SN) (located on the back of your system) • ARM Ver: (version) • PCBA Serial No: (number) See “To display the system information screen:” on page 51.

Chapter 2: Preparing the System

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Preparing System

Installing a License Key When you have obtained a license key for your software, you must enter it into the system. Once a valid license key has been entered, the system remains licensed until the next time the system software is upgraded. 1 Turn on the system. If the software is not yet licensed, the license update screen displays. The license update screen displays the following information: the License Update number, the ARM Ver (version), the PCBA Serial No. (number), the SonoSite web site address and telephone number, the license number, the register later or done remaining) on your system.

2

, and the grace period (time

Note: The software versions on your system may vary based on your upgrade and configuration. Enter your license key in the license number field. If the license key that you entered is recognized by the system as being valid for your system

and the software you installed, done appears on-screen. Select done from the on-screen menu to install the license key and license your software. If the license key that you entered is not recognized by the system, the register later button remains on the screen as long as the defined grace period has not expired. If the grace period has expired, the menu item will indicate this by showing zero hours remaining in the grace period. At this point, you must then enter a valid license key before you can use the system with this or any other transducer. Note: If you have entered a valid license key and you cannot complete the licensing procedure, verify that the license key has been entered correctly. The license key should be exactly 12 digits (for example, 123348990552) with no other characters or punctuation. Note: If after confirming correct entry of the license key, you are still unable to license your system, call SonoSite technical support. USA/Canada customers call 1-877-657-8118. International customers call your local representative or 1-425-951-1330. If the system is on and the grace period expires, the license update screen must be displayed from the system information screen.

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Chapter 2: Preparing the System

To display the system information screen:

Preparing System

1 Press and release the Function key. 2 Press and release I. The system information screen displays. The system information screen displays the following information: the Boot/PIC Vers (version), the ARM/DSP Vers, the PCBA Serial No (number), the Product Name, the Status, the PLD 1, 2, Vers, CPLD SH Ver, SHDB Ver (scanhead database version), and the Sh Serial No (scanhead serial number). Note: The software versions on your system may vary based on your upgrade and configuration.

To display the license update screen: 1 2

On the system information screen, select the unlock icon (upper left corner of the screen). The license update screen displays. Perform the steps in “Installing a License Key” on page 12.

Chapter 2: Preparing the System

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