User Guide
366 Pages
Preview
Page 1
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 Emergo Europe Molenstraat 15 2513 BH, The Hague The Netherlands
Australia Sponsor FUJIFILM SonoSite Australasia Pty Ltd 114 Old Pittwater Road BROOKVALE, NSW, 2100 Australia
Caution Federal (United States) law restricts this device to sale by or on the order of a physician. SonoMB, SonoSite, Steep Needle Profiling, X-Porte, and the SonoSite logo are trademarks or registered 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 8,216,146; 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: 97113678.5; DE: 69831698.3; DE: 69830539.6; DE: 69730563.5; DE: 602004027882.3; DE: 602004023816.3; DE: 60034670.6; DE: 60029777.2; EP: 1589878; EP: 1552792; EP: 1180971; EP: 0875203; EP: 0815793; EP 1180970; EP 0881492; ES: 2229318; ES: 159878; ES: 1552792; ES: 0881492; FR: 158978; FR: 1552792; FR: 1180970; FR: 0881492; FR: 0875203; FR: 0815793; GB: 158978; GB: 1552792; GB: 1180971; 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 Copyright © 2014 FUJIFILM SonoSite, Inc. All Rights reserved. Part Number: P14645-02 Publication Date: May 2014
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CONTENTS
CHAPTER 1 Introduction About the X-Porte User Guide Welcome to the X-Porte User Guide Document conventions Getting help
1 1 2 2 3
CHAPTER 2 Getting started About the system Accessories and peripherals Preparing the system Turning on the system Adjusting the height and angle USB devices USB memory sticks General interaction Clinical monitor Touch panel Onscreen keyboard Preparing transducers Connecting transducers Selecting a transducer and exam type Gel Sheaths Ports Battery charge indicator Transporting the system Visual Guide videos Intended uses Contraindications
5 5 6 7 7 8 9 9 10 10 11 12 13 13 16 20 21 21 21 22 23 25 26
CHAPTER 3 Setting up the system
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CONTENTS Administration settings About security settings Managing the Administrator account Protecting patient information Adding and managing user accounts Logging in Audio settings Calculations settings Cardiac calculations settings Obstetrics calculations settings Specifying gestational age and growth analysis Creating custom obstetrics measurements Viewing obstetric calculation tables Setting up custom obstetric tables Exporting and importing custom obstetric tables and measurements Deleting custom obstetric tables CDA Report settings Connectivity settings Importing and exporting connectivity settings Date and Time settings DICOM Configuring the system for DICOM transfer Connecting to the network DICOM configuration pages Configuration setup fields Associating devices with locations Display Information settings Labels Logs Network Status settings Power and Battery settings Presets settings General preferences Brightness Labels Exam types Customizing exam types User profile settings Importing and exporting Routing selections Associating routing selections with exams
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28 29 29 30 31 34 34 35 35 36 36 36 38 38 39 40 41 43 43 45 46 47 47 50 52 59 61 62 63 65 66 66 67 67 68 69 70 71 73 74 75
CONTENTS Specifying educational DICOM archivers System Information settings USB settings Limitations of JPEG format eFilm Lite image-viewer
76 77 77 79 79
CHAPTER 4 Imaging Understanding imaging modes 2D M-line M Mode Color D-line Doppler Dual Scanning 2D Color Dual Doppler M Mode Imaging controls Controls in 2D Controls in frozen 2D Controls in Color Controls in frozen Color Controls in M Mode Controls in frozen M Mode Controls in Doppler Controls in D-line Controls in scrolling Doppler Adjusting depth and gain Depth Gain Freezing, viewing frames, and zooming Freezing the image Viewing the cine buffer Zooming in on the image Visualizing needles
81 81 82 83 83 85 86 86 88 88 89 90 91 93 96 99 101 108 110 115 116 120 120 121 127 135 135 136 136 136 138 138 140
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CONTENTS Needle size and angle Additional recommendations Labeling images Text Arrows Pictographs Setting the home position Labeling during review Entering patient information Editing patient information Entering patient information manually Entering patient information from the worklist Updating and querying the worklist Ending the exam Patient form fields Images and clips Reviewing Patient list Reviewing images and video clips Printing images Archiving and exporting Archiving exams Exporting exams Saving images and video clips Saving images Saving video clips Managing internal storage space DVR recording ECG
143 143 143 143 145 146 147 147 150 150 151 151 153 155 156 158 158 158 161 164 165 165 168 169 170 171 172 173 174
CHAPTER 5 Measurements and calculations Measuring Calipers Viewing and deleting measurement results Basic measurements in 2D Basic measurements in M Mode Basic measurements in Doppler Automatic trace results Assigning measurements to calculations About calculations
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177 177 177 178 178 180 180 182 183 183
CONTENTS Overview Percent reduction calculations Volume calculation Volume flow calculation Required measurements Considerations Calculating volume flow Exam-based calculations Arterial calculations Cardiac calculations Gynecological calculations Measuring uterus Measuring ovaries Measuring follicles Obstetrics calculations Measuring gestational sacs Small Parts calculations Acute Care calculations Worksheets and reports Report preview Arterial and cardiac reports Obstetrics reports Obstetrics graphs Acute Care and MSK worksheets Printing reports and worksheets Displaying reports and worksheets after the exam has ended
184 186 188 188 189 189 189 190 190 192 207 207 208 209 209 215 215 217 220 221 221 222 222 223 224 225
CHAPTER 6 Measurement references Measurement accuracy Sources of measurement errors Measurement publications and terminology Cardiac references Obstetrical references Gestational age tables Abdominal Circumference (AC) Biparietal Diameter (BPD) Cisterna Magna (CM) Crown Rump Length (CRL) Femur Length (FL)
227 227 229 229 230 238 240 240 240 240 240 241
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CONTENTS Fetal Trunk Cross-Sectional Area (FTA) Gestational Sac (GS) Head Circumference (HC) Humerus (HL) Occipito-Frontal Diameter (OFD) Tibia Transverse Trunk Diameter (TTD) Growth analysis tables Abdominal Circumference (AC) Biparietal Diameter (BPD) Estimated Fetal Weight (EFW) Femur Length (FL) Head Circumference (HC) Head Circumference (HC)/Abdominal Circumference (AC) Ratio calculations FL/AC Ratio FL/BPD Ratio FL/HC Ratio HC/AC Ratio General references
241 241 241 241 242 242 242 242 242 242 242 243 243 243 243 243 243 244 244 244
CHAPTER 7 Troubleshooting and maintenance Troubleshooting Software licensing Maintenance Disinfecting System backups Patient data System configuration settings Servicing Cleaning and disinfecting Introduction Ultrasound system Cleaning and disinfecting the ultrasound system Compatible disinfectants for the ultrasound system Transducers Cleaning and disinfecting transducers Compatible disinfectants for standard transducers Compatible disinfectants for specialty transducers Accessories
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249 249 251 252 252 252 252 252 253 255 255 255 256 256 257 258 259 263 264
CONTENTS Cleaning and disinfecting accessories Cleaning and disinfecting the stand or Triple Transducer Connect (TTC) Cleaning the footswitch or ECG cable Compatible disinfectants for accessories
264 264 265 265
CHAPTER 8 Safety Ergonomic safety Position the system Position yourself Take breaks, exercise, and vary activities Electrical safety Electrical safety classification Isolating the X-Porte ultrasound system from power Equipment safety Clinical safety Hazardous materials Electromagnetic compatibility Wireless transmission Electrostatic discharge Separation distance Compatible accessories and peripherals Manufacturer’s declaration Immunity testing requirements Labeling Symbols Specifications Dimensions Environmental limits Operating Shipping and storage Electrical Imaging modes Image and video clip storage capacity Standards Electromechanical safety standards EMC standards classification DICOM standard HIPAA standard
271 271 272 272 273 273 275 275 276 277 278 278 279 279 281 281 284 288 288 293 293 293 294 294 294 294 294 295 295 295 296 296
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CONTENTS CHAPTER 9 Acoustic output ALARA principle Applying the ALARA principle Direct, indirect, and receiver controls Acoustic artifacts Guidelines for reducing MI and TI Output display MI and TI output display accuracy Factors that contribute to display uncertainty Related guidance documents Transducer surface temperature rise Acoustic output measurement In Situ, derated, and water value intensities Tissue models and equipment survey Acoustic output tables Acoustic measurement precision and uncertainty Terminology in acoustic output tables
Glossary General terms Terminology in acoustic output tables
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CHAPTER 1
Introduction This section introduces the X-Porte ultrasound system and this user guide.
About the X-Porte User Guide The X-Porte User Guide is intended for a user familiar with ultrasound. It does not provide training in sonography, ultrasound, or clinical practices. Before using the X-Porte ultrasound system, you must complete such training.
About the X-Porte User Guide
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Welcome to the X-Porte User Guide
Document conventions A WARNING describes precautions necessary to prevent injury or loss of life. A Caution describes precautions necessary to protect the products. Numbered and lettered steps must be performed in a specific order. Bulleted lists present information in list format but do not imply a sequence.
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CHAPTER 1
For a description of labeling symbols that appear on the product, see "Labeling Symbols" on page 288.
Getting help In addition to the X-Porte User Guide, the following are available: Visual Guide videos. See "Visual Guide videos" on page 23. On-system Help: tap MORE, and then tap Help. X-Porte Getting Started Guide. Service manual. FUJIFILM SonoSite Technical Support Phone (U.S. or Canada) (877) 657-8118 Phone (Outside U.S. or Canada) (425) 951-1330, or call your local representative Fax (425) 951-6700 E-mail [email protected] Web www.sonosite.com Europe Service Center Main: +31 20 751 2020 English support: +44 14 6234 1151 French support: +33 1 8288 0702 German support: +49 69 8088 4030 Italian support: +39 02 9475 3655 Spanish support: +34 91 123 8451 Asia Service Center +65 6380-5589 Printed in the U.S.
Getting help
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CHAPTER 1
CHAPTER 2
Getting started WARNING Do not use the system if it exhibits erratic or inconsistent behavior. Such behavior indicates a hardware failure. Contact FUJIFILM SonoSite Technical Support.
About the system X-Porte is a portable device that acquires and displays high-resolution, realtime ultrasound images. Features available depend on your system configuration, transducer, and exam type.
About the system
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Figure 2-1 X-Porte front view 1. Clinical monitor, 2. Touch panel, 3. Platform, 4. Hook (4), 5. Transducer connector, 6. Locking wheel (4), 7. Height-adjustment pedal, 8. Basket, 9. USB ports (3), 10. Power button
Figure 2-2 X-Porte rear view 1. Ports on dock, 2. Power cord connector, 3. Battery charge indicator, 4. Ports on dock
A license key is required to activate the software. See "Software licensing" on page 251. Basic operating steps 1 Connect a transducer. See "Connecting transducers" on page 13. 2 Turn on the system. See "Turning on the system" on the facing page. 3 Select the transducer and exam type (or use the default selections). See "Selecting a transducer and exam type" on page 16. 4 (Optional) Enter patient information. See "Entering patient information" on page 150. 5 Scan. See "Scanning" on page 88.
Accessories and peripherals The system supports various accessories and peripherals. See "Compatible accessories and peripherals" on page 281.
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CHAPTER 2
Preparing the system Turning on the system WARNING Verify that the hospital supply voltage corresponds to the power supply voltage range. WARNING Plug the system only into a grounded hospital-grade outlet. WARNING Use only power cords provided by FUJIFILM SonoSite with the system. Caution Do not use the system if an error message appears on the clinical monitor. Note the error code and turn off the system. Call FUJIFILM SonoSite or your local representative. Caution When using AC power, position the system to allow easy access to disconnect it. To turn on the system The system can be powered by the internal battery or by AC power. 1 If you are operating the system using AC power, connect the AC power cord to the stand, and then connect the AC power cord to a hospital-grade outlet. 2 Press the power button. The power button turns green when the system is ready for scanning. If the system does not maintain expected battery charge, or if the battery icon on the clinical monitor does not display the battery charge status, disconnect and reconnect the system to AC power. Connect the system to AC power to maintain battery charge, especially if the system will not be used for several days. To connect the system to AC power (battery charge maintenance) 1 Turn off the system. 2 Disconnect the system from AC power. 3 Check the battery switches; ensure that all three switches are depressed to the ʘ symbol, which is the ON position. Note The system will not charge and maintain the batteries if the battery switches are depressed to the ·O symbol, which is the OFF position. 4 Reconnect the system to AC power. The battery charge indicator at the base of the stand blinks green, and the battery icon on the clinical monitor displays the battery charging state. To turn off the system Note If the system appears unresponsive, wait several minutes before restarting it. Restarting the system while it is performing data-intensive background activities, such as transferring patient files, can result in loss of patient data. To power down an unresponsive system, press and hold the power button until the system shuts down. This procedure may take 5 seconds or longer. Press the power button.
Preparing the system
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Adjusting the height and angle WARNING Lock the wheels whenever the system is unattended or stationary. WARNING To avoid possible injury from an unexpected clinical monitor collapse during system transport, collapse the clinical monitor before system transport (see "To collapse the clinical monitor" below). To raise or lower the platform While pressing down the height-adjustment pedal, grasp both sides of the platform and push down or pull up to the desired height. To lock a wheel Press down the lever on the wheel. To unlock the wheel, press up on the bottom of the lever. To adjust the clinical monitor angle Grasping the clinical monitor on both sides, tilt or rotate it. To adjust the touch-panel angle Grasping the sides of the touch panel, pull it forward or push it backward to the desired angle. To collapse the clinical monitor Always collapse the clinical monitor before system transport. 1. Adjust the touch panel angle to the lowest position. 2. Grasping the clinical monitor on both sides, align it squarely above the touch panel. 3. Fold the clinical monitor downward over the touch panel.
Figure 2-3 Clinical monitor collapsed for system transport
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CHAPTER 2
USB devices You can use the USB ports on the system for connecting devices such as a USB printer or a USB memory stick. (For a list of supported devices, see "Compatible accessories and peripherals" on page 281. One of the USB ports at the back of the system is for DVR recording only. See "Ports" on page 21 and "DVR recording" on page 173.
USB memory sticks You can use a USB memory stick to export patient exams, import and export logs and setup configurations, and to import custom obstetric calculation tables. Note The system does not support password-protected USB memory sticks. Make sure that the USB memory stick you use does not have password protection enabled. Caution To avoid damaging the USB memory stick and losing patient data from it, observe the following: Do not remove the USB memory stick or turn off the ultrasound system while the system is exporting. Do not bump or otherwise apply pressure to the USB memory stick while it is in a USB port on the ultrasound system. The connector could break. Caution If the USB icon
does not appear in the system status area on the clinical monitor, the
USB memory stick may be defective or password-protected. Replace the USB memory stick. To connect a USB memory stick for importing or exporting Insert the USB memory stick into a USB port (see "About the system" on page 5).
The USB memory stick is ready when the USB icon
appears onscreen.
To view information about the device, see "USB settings" on page 77. To disconnect a USB memory stick Disconnecting the USB memory stick while the system is exporting to it may cause the exported files to be corrupted or incomplete.
1 If exporting, wait at least five seconds after the USB animation icon
stops.
2 Remove the USB memory stick from the port.
Preparing the system
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General interaction Clinical monitor WARNING FUJIFILM SonoSite recommends against using a monitor other than the clinical monitor provided by FUJIFILM SonoSite. Using a different monitor may result in image distortion and degradation of image quality. The clinical monitor displays the ultrasound image as well as details about the exam and system status.
Figure 2-4 Clinical monitor layout Legend: 1. Patient header 2. Measurement and calculation area 3. Selected transducer, exam type, and MI and TI values 4. Imaging mode or modes, controls selected 5. System status area 6. Depth scale
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CHAPTER 2