Page 1 SonoSite Edge II USER GUIDE Ultrasound System User Guide...
Page 2 1552792; FR 1180970; FR0881492; 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 and pending. Part Number: P20516-02 Publication Date: March 2016 Copyright © 2016 FUJIFILM SonoSite, Inc. All Rights reserved.
Page 3: Table Of Contents
Contents Chapter 1: Introduction About the SonoSite Edge II User Guide ..............1 Document conventions ..................1 Getting help ........................2 Chapter 2: Getting Started About the system ......................3 Intended use ........................3 Hardware features ......................6 Preparing the system ....................7 Installing or removing the battery ..............
Page 4 OB Custom Tables setup ...................31 Presets setup .........................33 System Information setup ..................34 USB Devices setup .......................34 Limitations of JPEG format ................35 eFilm Lite image-viewer ...................36 Chapter 4: Imaging Imaging modes ......................37 2D imaging ......................37 M Mode imaging ....................39 CPD and color Doppler imaging ..............40 PW and CW Doppler imaging ................41 Adjusting depth and gain ..................44 Freezing, viewing frames, and zooming .............45...
Page 5 Small Parts and MSK calculations .............. 100 Transcranial Doppler and Orbital calculations ........101 Vascular calculations ..................104 Patient report ......................106 Vascular and cardiac patient reports ............106 TCD patient report ..................107 OB patient report ..................... 107 EMED and MSK worksheets ................. 108 Chapter 6: Measurement References Measurement accuracy ..................
Page 6 Hazardous materials ....................155 Electromagnetic compatibility ................156 Wireless transmission ..................157 Electrostatic discharge .................. 157 Separation distance ..................159 Compatible accessories and peripherals ..........159 Manufacturer’s declaration ................162 Labeling symbols ...................... 165 Specifications ......................170 Dimensions ......................170 Environmental limits ..................
Page 7: Chapter 1: Introduction
Other accessories and third-party equipment are subject to their own instructions and restrictions. The SonoSite Edge II Ultrasound System User Guide is intended for a user familiar with ultrasound. It does not provide training in sonography, ultrasound, or clinical practices. Before using the system, you must complete such training.
Page 8: Getting Help
Getting help In addition to this user guide, the following resources are available: Instructional videos available on-line. FUJIFILM SonoSite Technical Support: Phone 877-657-8118 (U.S. or Canada) Phone 425-951-1330, or call your local representative (outside U.S. or Canada) 425-951-6700 Email service@sonosite.com www.sonosite.com...
Page 9: Chapter 2: Getting Started
Chapter 2: Getting Started Use this section to help familiarize yourself with the SonoSite Edge II ultrasound system and its uses. About the system The SonoSite Edge II 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.
Page 10 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.
Page 11 Note For the intended transducer and imaging modes for each exam type, refer to “Imaging modes and exams available by transducer” on page 50. Contraindications The SonoSite Edge II ultrasound system has no known contraindications. Intended use...
Page 12: Hardware Features
Hardware features The front of the system is shown in Figure 2-1. Figure 2-1 Front of the SonoSite Edge II Ultrasound System Control panel USB ports AC power indicator Handle Display The back of the system is shown in Figure 2-2.
Page 13: Preparing The System
Basic operating steps 1 Attach a transducer. 2 Turn the system on. For power switch location, see “System controls” on page 13. 3 Press the PATIENT key, and complete the patient information form. 4 Press an imaging mode key:  ...
Page 14 3 Place the battery into the battery compartment, at a slight angle. 4 Slide the battery forward until it locks into place. 5 Slide the two locking levers outward to secure the battery. 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.
Page 15: Using Ac Power And Charging The Battery
Using AC power and charging the battery When using AC power, position the system to allow easy access to disconnect it. Caution When using AC power, position the system to allow easy access to disconnect it. The battery charges when the system is connected to the AC power supply. A fully discharged battery recharges in less than five hours.
Page 16: Turning The System On Or Off
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. To turn the system on or off ...
Page 17 2 Pull the transducer latch up, and rotate it clockwise. Align the transducer connector with the connector on the bottom of the system. 3 Insert the transducer connector into the system connector. 4 Turn the latch counterclockwise. 5 Press the latch down, securing the transducer connector to the system. To remove a transducer 1 Pull the transducer latch up.
Page 18: Inserting And Removing Usb Storage Devices
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. Note USB storage devices must be in FAT-32 format. 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.
Page 19: System Controls
System controls NEAR SELECT SAVE CALC UPDATE PROGRAM ZOOM CALIPER CLIP DOPPLER COLOR GAIN MODE CALC SAVE FREEZE DEPTH AUTO Table 2-1: Keyboard map Control keys Adjust on-screen controls. Alphanumeric keys Enter text and numbers. Annotation keys “Alphanumeric keyboard” on page 17. Gain NEAR Adjusts the gain applied to the near field of the image.
Page 20 Table 2-1: Keyboard map (continued) AUTO Adjusts gain automatically. Magnifies the image 100%. ZOOM DEPTH UP, Decreases and increases imaging depth. DEPTH DOWN Sets a trace measurement. CALIPER Displays calipers on-screen for measuring. CALC Turns the calculations menu on and off. Touchpad Selects, adjusts, and moves items on-screen.
Page 21: Screen Layout
Table 2-1: Keyboard map (continued) EXAM Opens exam menu. REVIEW Accesses the patient list, saved images, and archiving functions. REPORT Accesses the patient report and EMED worksheets. Power switch Turns system on and off. Screen layout Sample screen: Table 2-2: Screen map Mode Data Area Current imaging mode information (for example, Gen, Res, THI, and PW).
Page 22: General Interaction
Table 2-2: Screen map (continued) Calculations Menu Contains available measurements. Image Ultrasound image. Measurement and Current data on measurements and calculations. Calculations Data Area On-screen Controls Controls available in the current context. Patient Header Header details such as current patient name, ID number, user, and date/ time.
Page 23: Annotation And Text
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. Refer to “Audio, Battery setup”...
Page 24 Table 2-3: Alphanumeric keyboard map (continued) TEXT Turns the keyboard on and off for text entry. PICTO Turns pictographs on and off. arrow Displays an arrow graphic that can be moved and rotated within the image area. spacebar Turns the keyboard on for text entry. In text entry, adds a space. DELETE Removes all text from the screen during text entry and when not measuring.
Page 25: Preparing The Transducers
Some gels and disinfectants can cause an allergic reaction on some individuals. To avoid damage to the transducer, use only gels recommended by FUJIFILM Cautions SonoSite. Using gels other than the one recommended by FUJIFILM SonoSite can damage the transducer and void the warranty.
Page 26 To apply a transducer sheath  For invasive use, apply a transducer sheath. FUJIFILM SonoSite recommends the use of market-cleared, transducer sheaths for intracavitary applications.To lessen the risk of contamination, apply the sheath only when you are ready to perform the procedure.
Page 27: Chapter 3: System Setup
Chapter 3: 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 SETTINGS 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 ...
Page 28: Administration Setup
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 To avoid contamination, do not use the footswitch in a sterile environment. The footswitch is not sterilized.
Page 29: User Setup
To require user login You can set the system to display the User Login screen at startup. 1 Log in as Administrator. 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.
Page 30: Exporting Or Importing User Accounts
6 Select Save. To modify user information 1 Log in as Administrator. 2 Under User List, select the user. 3 Under User Information, make changes as desired. 4 Select Save. Note Any change to the user name replaces the previous name. To delete a user 1 Log in as Administrator.
Page 31: Exporting And Clearing The Event Log
4 Select the USB storage device, and select Export. Note 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. 2 Log in as Administrator. 3 Select Import on-screen.
Page 32: Logging In As User
To clear the Event log 1 Display the Event log. 2 Select Clear on-screen. 3 Select Yes. 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 23.
Page 33 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 56. 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.
Page 34: Audio, Battery Setup
4 Select Done in the dialog box that appears. All predefined label groups for all exams are replaced with those from the USB storage device. Audio, Battery setup  On the Audio, Battery setup page, select options in the following lists: Key click.
Page 35: Date And Time Setup
To enable wireless connection  See Setting Up a Wireless Network. To receive storage alerts  On the Connectivity setup page, select Internal Storage Capacity Alert. The system displays a message if internal storage is near capacity when you end an exam. The system then deletes archived patient exams if specified in DICOM setup.
Page 36: Network Status Setup
Network Status setup The Network Status setup page displays information on: System IP address Location Ethernet MAC address The wireless connection (if any) OB Calculations setup On the OB Calculations setup page, you select authors for OB calculation tables. You can also import or export additional OB calculation tables.
Page 37: Ob Custom Measurements Setup
2 On the OB Calculations setup page, select Import on-screen. 3 Select the USB storage device, and then select Import. 4 Select OK in the dialog box that appears. The system restarts. OB Custom Measurements setup On the OB Custom Measurements setup page, you can define measurements that appear in the OB calculations menu and OB report.
Page 38 The system provides gestational age measurements by selected authors for the following: GS CRL BPD OFD HC TTD APTD AC FTA FL EFW Tibia HL Five additional custom measurement labels Growth Analysis Table Measurements The system provides growth graphs or curves for the following: BPD HC AC...
Page 39: Presets Setup
5 In the Author box, type a unique name. 6 Enter the data. 7 Select Save on-screen. To display the measurement for the custom table in the calculations menu, see “To specify gestational age and growth analysis” on page 30. To edit or delete an OB custom table 1 On the OB Calculations or OB Custom Measurements setup page, select Tables on-screen.
Page 40: System Information Setup
SiteLink organizes files in a SiteLink-style folder structure. Clips export in H.264 video saved as MP4 files. To view them, FUJIFILM SonoSite recommends QuickTime 7.0 or later. DICOM creates files readable by a DICOM reader. DICOM is an optional feature.
Page 41: Limitations Of Jpeg Format
2 Under USB Export select the AutoExport box. To include private tags If you use DICOM export type and a FUJIFILM SonoSite software product, include private tags on the images.  On the USB Devices setup page, select Include private tags.
Page 42: Efilm Lite Image-Viewer
eFilm Lite image-viewer You can include a copy of the eFilm Lite image-viewer with exams that you export to a USB memory stick in DICOM format. eFilm Lite lets you view DICOM-formatted images on a computer running Windows. Note eFilm Lite is a licensed feature. To start eFilm Lite image-viewer after exporting exams 1 Insert the USB memory stick into your computer.
Page 43: Chapter 4: Imaging
Chapter 4: Imaging Imaging modes The system has a high-performance display and advanced image-optimization technology that simplifies user controls. Imaging modes available depend on the transducer and exam type. See “Imaging modes and exams available by transducer” on page 50. 2D imaging 2D is the system's default imaging mode.
Page 44 Displays the ECG trace. Refer to “ECG Monitoring” on page 65. This feature is optional and requires a FUJIFILM SonoSite ECG cable. Clips Displays the clip controls. Refer to “To capture and save a clip”...
Page 45: M Mode Imaging
Table 4-1: 2D on-screen controls (continued) Turns Tissue Harmonic Imaging on and off. When on, THI appears in the upper left-hand screen. This feature depends on transducer and exam type. Centerline Turns the centerline graphic on or off. See“Centerline” on page 49. Page x/x Indicates which page of controls is displayed.
Page 46: Cpd And Color Doppler Imaging
To set a duplex layout “Presets setup” on page 33. CPD and color Doppler imaging Color Power Doppler (CPD) and color Doppler (Color) are optional features. CPD is used to visualize the presence of detectable blood flow. Color is used to visualize the presence, velocity, and direction of blood flow in a wide range of flow states.
Page 47: Pw And Cw Doppler Imaging
Table 4-2: CPD and Color on-screen controls (continued) Flow The current setting appears on-screen. Low optimizes the system for low flow states. Sensitivity Med optimizes the system for medium flow states. High optimizes the system for high flow states. PRF Scale Select the desired pulse repetition frequency (PRF) setting by pressing the control keys.
Page 48 To display the D-line The default Doppler imaging mode is PW Doppler. In cardiac exams, you can select the CW Doppler on-screen control. 1 Press the D key. Note If the D-line does not appear, make sure that the image isn’t frozen. 2 Do any of the following as needed: Adjust controls as described in “PW Doppler controls”...
Page 49 PW Doppler controls In PW Doppler imaging, you can set the following on-screen controls. Table 4-3: PW Doppler on-screen controls PW, CW CW applies to Cardiac exam only. Toggle between PW Doppler and CW Doppler. The current selection appears in the upper left-hand screen. Corrects the angle to 0°, +60°, or -60°.
Page 50: Adjusting Depth And Gain
Table 4-4: Spectral trace on-screen controls (continued) Line Sets the baseline position. (On a frozen trace, the baseline can be adjusted if Live Trace is off.) Invert Vertically flips the spectral trace. (On a frozen trace, Invert is available if Live Trace is off.) Volume Increases or decreases Doppler speaker volume (0-10).
Page 51: Freezing, Viewing Frames, And Zooming
To adjust gain manually  Turn the gain knobs to the left to decrease gain. Turn the knobs to the right to increase gain: NEAR adjusts the gain applied to the near field of the 2D image. FAR adjusts the gain applied to the far field of the 2D image. GAIN adjusts the overall gain applied to the entire image.
Page 52: Needle Visualization
Needle visualization WARNING To avoid incorrect needle placement when SNP is on: Using movement and fluid injection, verify the needle-tip location and trajectory. Steep Needle Profiling technology enhances linear structures within a selected angle range on the ultrasound plane. Linear structures outside the selected angle —...
Page 53 Figure 4-1 Image with SNP on (linear transducer) Needle Dotted line Outlined area enhanced by SNP Unenhanced area Figure 4-2 With a curved array transducer, only segments of the needle shaft may show Upper needle shaft Needle tip Segment of needle shaft not shown (depends on specific image) Needle visualization...
Page 54: Needle Size And Angle
Needle size and angle Use a 17-gauge to 25-gauge needle (recommended). Enhancement results can depend on the type and brand of needle used. For more information, consult the medical literature on needle visibility in ultrasound-guided procedures. You can angle the needle up to 50° from the transducer surface as shown in Figure 4-3.
Page 55: Additional Recommendations
Back returns to the previous screen. If Steep Needle Profiling technology is on, SNP is highlighted and SNP appears in the mode data area. Pressing SNP again redisplays the SNP controls. Note If Steep Needle Profiling technology is on, the MB control is unavailable. Additional recommendations Avoid setting the gain too high when using Steep Needle Profiling technology, as unnecessarily high gain can cause artifacts in the image.
Page 56: Imaging Modes And Exams Available By Transducer
Small tilts or rotations of the transducer can affect the relationship between any external reference points and the anatomy that appears on the ultrasound image. Figure 4-5 Relationship of the ultrasound image to the transducer angle or tilt. Imaging modes and exams available by transducer To prevent misdiagnosis or harm to the patient, understand your system’s WARNINGS capabilities prior to use.
Page 57 On the patient information form, select from the Type list under Exam. See “Patient information form” on page 57. Table 4-6: Imaging modes and exams available by transducer Imaging mode Transducer Exam Type Color Doppler M Mode Doppler C11x rC60xi standard/ armored Imaging modes and exams available by transducer...
Page 58 Table 4-6: Imaging modes and exams available by transducer (continued) Imaging mode Transducer Exam Type Color Doppler M Mode Doppler HFL38xi Lung HFL50x Imaging modes and exams available by transducer...
Page 59 Table 4-6: Imaging modes and exams available by transducer (continued) Imaging mode Transducer Exam Type Color Doppler M Mode Doppler HSL25x Lung ICTx Imaging modes and exams available by transducer...
Page 60 Table 4-6: Imaging modes and exams available by transducer (continued) Imaging mode Transducer Exam Type Color Doppler M Mode Doppler L25x Lung L38xi standard/ armored Lung P10x Imaging modes and exams available by transducer...
Page 61: Annotating Images
Table 4-6: Imaging modes and exams available by transducer (continued) Imaging mode Transducer Exam Type Color Doppler M Mode Doppler P11x rP19x standard/ armored Lung TEExi a. Exam type abbreviations are as follows: Abd = Abdomen, Art = Arterial, Bre = Breast, Crd = Cardiac, Gyn = Gynecology,Msk = Musculoskeletal, Neo = Neonatal, Nrv = Nerve, OB = Obstetrical, Oph = Ophthalmic, Orb = Orbital, SmP = Small Parts, Sup = Superficial, TCD = Transcranial Doppler, Ven = Venous.
Page 62 To place text on an image You can place text in the following imaging layouts: full-screen 2D, full-screen trace, dual, or duplex. You can place text manually or add a predefined label. 1 Press the TEXT key. A highlighted cursor appears. 2 Move the cursor where desired: Use the touchpad or arrow keys.
Page 63: Patient Information Form
2 If you need to adjust the arrow's orientation, press the SELECT key and then use the touchpad. When the orientation is correct, press the SELECT key again. 3 Using the touchpad, position the arrow where desired. 4 Press the arrow key to set the arrow. The arrow turns white. a To remove the arrow, press the arrow key and then select Hide.
Page 64 3 Fill in the form fields.as described in “Patient information form fields” on page 58. 4 Select Done. also“To append images and clips to a patient exam” on page 62. To enable bar code lookup of patient data You can query the worklist for patient data by scanning a Patient ID bar code with the bar code scanner. The patient data are then automatically entered into the patient information form.
Page 65 Accession Enter number, if applicable Date of birth Gender Indications Enter desired text User User initials Procedure (button) Available if the DICOM worklist feature is licensed and configured. Refer to the document Sending and Receiving DICOM Data on SonoSite Systems. ...
Page 66: Images And Clips
Institution Department ID Images and clips Saving images and clips When you save an image or clip, it saves to internal storage. The system beeps afterward if Beep Alert is on, and the percentage icon flashes. See “Audio, Battery setup” on page 28.
Page 67: Reviewing Patient Exams
Reviewing patient exams Caution If the internal storage icon does not appear in the system status area, internal storage may be defective. Contact FUJIFILM SonoSite Technical Support. See “Getting help” on page 2. The patient list organizes saved images and clips in patient exams. You can delete, view, print, or archive exams.
Page 68 To sort the patient list After the system starts, the patient list is arranged by date and time, with the most recent patient file first. You can re-sort the patient list as needed.  Select the column heading that you want to sort by. Select it again if sorting in reverse order. Note column heading is selectable.
Page 69: Printing, Exporting, And Deleting Images And Clips
3 Select x/x to cycle to the image or clip you want to review. 4 (Clip Only) Select Play. The clip plays automatically after loading. The load time depends on clip length. Note You can select Pause to freeze the clip and can select a playback speed 1x, 1/ 2x, 1/4x.
Page 70 To export patient exams to a USB storage device You can export patient exams if they are ended. See “To end the exam” on page 58. A USB storage device is for temporary storage of images and clips. Patient exams should be archived regularly. To specify file format, see “USB Devices setup”...
Page 71: Ecg Monitoring
1 On the patient list, select the exam. 2 Select Info. ECG Monitoring ECG Monitoring is an optional feature and requires a FUJIFILM SonoSite ECG cable. To prevent misdiagnosis, do not use the ECG trace to diagnose cardiac rhythms. WARNINGS The FUJIFILM SonoSite ECG control is a non-diagnostic feature.
Page 72 3 Adjust controls as desired. ECG Monitoring controls Table 4-8: ECG on-screen controls Show/Hide Turns on and off ECG trace. Gain Increases or decreases ECG gain. Settings are 0-20. Position Sets the position of the ECG trace. Sweep Speed Settings are Slow, Med, and Fast. Delay Displays Line and Save for clip acquisition delay.
Page 73: Chapter 5: Measurements And Calculations
Chapter 5: Measurements and Calculations You can measure for quick reference, or you can measure within a calculation. You can perform general calculations as well as calculations specific to an exam type. Measurements are performed on frozen images. For references used, refer to Chapter 6, “Measurement References.
Page 74: 2D Measurements
Within a calculation, calipers appear when you select from the calculations menu. Refer to “To select from the calculations menu” on page 73. Note For an accurate measurement, accurate placement of calipers is essential. To switch the active calipers  Do one of the following: To switch the active caliper within a set, press the SELECT key.
Page 75 You can perform a combination of distance, area, circumference, and manual trace measurements at one time. The total number possible depends on their order and type. To measure distance (2D) You can perform up to eight distance measurements on a 2D image. 1 On a frozen 2D image, press the CALIPER key.
Page 76: M Mode Measurements
M Mode measurements The basic measurements that you can perform in M Mode imaging are as follows: Distance in cm/Time in seconds Heart Rate (HR) in beats per minute (bpm) The time scale above the trace has small marks at 200 ms intervals and large marks at one-second intervals. To measure distance (M Mode) You can perform up to four distance measurements on an image.
Page 77  Resistive Index (RI) Acceleration You can also trace manually or automatically. For Doppler measurements, the Doppler scale must be set to cm/ s. See “Presets setup” on page 33. To measure Velocity (cm/s) and Pressure Gradient (Doppler) 1 On a frozen Doppler spectral trace, press the CALIPER key. A single caliper appears. 2 Using the touchpad, position the caliper to a peak velocity waveform.
Page 78 3 Using the touchpad, position the caliper at the beginning of the desired waveform, and press the SELECT key. Note If calipers are not positioned correctly, the result is inaccurate. 4 Using the touchpad, trace the waveform. a To make a correction, select Undo on-screen, backtrack with the touchpad, or press the backspace key. b Press the SET key.
Page 79: General Calculations
Acceleration Time (AT) Time Average Peak (TAP) Gate Depth General calculations Within calculations, you can save measurement results to the patient report. You can display, repeat, and delete measurements from a calculation. Some measurements can be deleted directly from the patient report pages.
Page 80: Performing And Saving Measurements
Performing and saving measurements In performing a measurement within a calculation, you select from the calculations menu, position the calipers that appear, and then save the calculation. Unlike measurements performed outside a calculation, the calipers appear by selecting from the calculations menu, not by pressing the CALIPER key. The type of calipers that appear depends on the measurement.
Page 81: Emed Calculations
2 Select Delete on-screen. The measurement last saved is deleted from the patient report. If it is the only measurement, the check mark is deleted from the calculations menu. Note Some measurements can be deleted directly from the patient report pages. See “Patient report”...
Page 82: Volume Calculations
1 On a frozen 2D image, press the CALCS key. 2 Do the following for A and then for A a From the calculations menu, select the measurement name under Area Red. b Using the touchpad, move the caliper to the trace starting point, and press the SELECT key. c Using the touchpad, trace the desired area.
Page 83: Volume Flow Calculations
To calculate volume The volume calculation involves three 2D distance measurements: D , and D . After all measurements are saved, the result appears on-screen and in the patient report.  Do the following for each image you need to measure: a On the frozen 2D image, press the CALCS key.
Page 84 Use the gate size. If you do not measure the diameter of the vessel, the system automatically uses the gate size and “(gate)” appears in the calculation results. The Doppler sample volume should completely insonate the vessel. You can measure either the time average mean or time average peak.
Page 85: Exam-Based Calculations
c Using the touchpad, position the vertical caliper at the beginning of the waveform. Note If calipers are not positioned correctly, the calculation result is inaccurate. d Press the SELECT key to display a second vertical caliper. e Using the touchpad, position the second vertical caliper at the end of the waveform. f Press the SET key to complete the trace and to display the results.
Page 86 The following table shows the measurements required to complete different cardiac calculations. For definitions of acronyms, see the“Glossary” on page 237. Table 5-1: Cardiac calculations and results Calculation list Measurement name (imaging mode) Results LVDd (2D or M Mode) EF…EF LVDs (2D or M Mode) …LV Vol (EF) A4Cd (2D)
Page 87 Table 5-1: Cardiac calculations and results (continued) Calculation list Measurement name (imaging mode) Results Ao (2D or M Mode) Ao/LA LA/Ao AAo (2D) LA (2D or M Mode) LA/Ao LVOT D (2D) LVOT D LVOT area ACS (M Mode) LVET (M Mode) LVET EF:Slope (M Mode) EF SLOPE...
Page 88 Table 5-1: Cardiac calculations and results (continued) Calculation list Measurement name (imaging mode) Results LVOT D (2D) HR (Doppler) LVOT VTI (Doppler) LVOT D Max D (2D or M Mode) Collapse ratio Min D (2D or M Mode) LA A4C (2D) Atria LA Area LA Volume...
Page 89 Table 5-1: Cardiac calculations and results (continued) Calculation list Measurement name (imaging mode) Results Vmax (Doppler) AV…AV Vmax PGmax VTI (Doppler) Vmax PGmax Vmean PGmean …LVOT Vmax (Doppler) Vmax PGmax VTI (Doppler) Vmax PGmax Vmean PGmean …AI PHT (Doppler) AI PHT AI slope TRmax (Doppler) Vmax...
Page 90 Table 5-1: Cardiac calculations and results (continued) Calculation list Measurement name (imaging mode) Results Vmax (Doppler) Vmax PGmax VTI (Doppler) Vmax AT (Doppler) PGmax Vmean PGmean Ann D (2D) PISA PISA Area Radius (Color) MV Rate Regurgitant Volume MR VTI (Doppler) Regurgitant Fraction MV VTI (Doppler) LVOT D (2D)
Page 91 Table 5-1: Cardiac calculations and results (continued) Calculation list Measurement name (imaging mode) Results a. You can enter the HR measurement three ways: Patient information form, Doppler measurement. See “To calculate Heart Rate (HR)” on page 86, or M Mode measurement See “To measure heart rate (M Mode)”...
Page 92 4 Press the SELECT key, and position the second caliper. 5 Press the SELECT key. Another caliper appears, and the calculations menu highlights the next measurement name. 6 Position the caliper, and press the SELECT key. Repeat for each measurement name in the calculation group.
Page 93 3 Adjust the distance of the calipers using the touchpad. 4 Save the calculation as described in “To save a calculation” on page 74 To measure TAPSE 1 On a frozen M Mode trace, press the CALCS key. 2 From the calculations menu, select the measurement name. 3 Adjust the distance of the calipers using the touchpad.
Page 94 6 Save the calculation as described in “To save a calculation” on page 74. To calculate LV Mass 1 On a frozen 2D image, press the CALCS key. 2 In the calculations menu, locate LV mass. 3 Do the following for EPI and then for Endo: a Select the measurement name from the calculations menu.
Page 95 To calculate Velocity Time Integral (VTI) Note This calculation computes other results in addition to VTI. Refer to Table 5-1 page 80. 1 On a frozen Doppler spectral trace, press the CALCS key. 2 From the calculations menu, select VTI under MV, AV, TV, PV, or LVOT. 3 Position the caliper at the start of the waveform, and press the SELECT key to start the trace.
Page 96 In AV, position the caliper at the end diastole. 4 Save the calculation as described in “To save a calculation” on page 74. To calculate Proximal Isovelocity Surface Area (PISA) The PISA calculation requires a measurement in 2D, a measurement in Color, and two measurements in Doppler spectral trace.
Page 97 2 Using the touchpad, position the caliper at the aortic valve closure. 3 Press the SELECT key. A second vertical caliper appears. 4 Using the touchpad, position the second caliper at onset of mitral inflow. 5 Save the calculation as described in “To save a calculation”...
Page 98 2 In Doppler, measure LVOT Vmax, and then measure AV Vmax. See “To measure peak velocity” on page 88. From the calculations menu, select AV, select sample site, and then select Vmax.: Note Vmax can also be determined from the VTI measurement. See “To calculate Velocity Time Integral (VTI)”...
Page 99 a On a frozen 2D image, press the CALCS key. b From the calculations menu select Ao/LA then LVOT D. c Position the calipers. d Save the calculation as described in “To save a calculation” on page 74. 3 Measure from LVOT (Doppler). Refer to “To calculate Velocity Time Integral (VTI)”...
Page 100 d Save the calculation as described in “To save a calculation” on page 74. Trace automatically (Doppler). The automatic trace tool always measures the peak regardless of the Live Trace setting in Presets setup. a Display the Doppler spectral trace (waveform). b Select Trace on-screen, and then select Above or Below for the position of the automatic trace tool relative to the baseline.
Page 101: Gynecology (Gyn) Calculations
Gynecology (Gyn) calculations Gynecology (Gyn) calculations include Uterus, Ovary, Follicle, and Volume. For instructions to calculate volume, refer to “Volume calculations” on page 76. WARNING To avoid incorrect calculations, verify that the patient information, date, and time settings are accurate. To avoid misdiagnosis or harming the patient outcome, start a new patient information form before starting a new patient exam and performing calculations.
Page 102: Ob Calculations
OB calculations EFW is calculated only after appropriate measurements are completed. If any one of these parameters results in an EDD greater than what the OB calculation tables provide, the EFW is not displayed. Make sure that you have selected the OB exam type and the OB author for the WARNINGS OB calculation table you intend to use.
Page 103 Table 5-2: Results from System-Defined OB Measurements and Table Authors Calculation Result Gestational OB Measurements Table Authors — Gestational Age Hansmann, Nyberg, Tokyo U. Hadlock, Hansmann, Osaka, Tokyo U. Chitty, Hadlock, Hansmann, Osaka, Tokyo U. Hansmann Chitty, Hadlock, Hansmann Hansmann, Tokyo U. APTD Tokyo U.
Page 104 Table 5-2: Results from System-Defined OB Measurements and Table Authors (continued) Calculation Result Gestational OB Measurements Table Authors Ratios HC/AC Campbell FL/AC Hadlock FL/BPD Hohler FL/HC Hadlock Amniotic Fluid Index Jeng Growth Analysis Chitty, Hadlock, Jeanty Tables Chitty, Hadlock, Jeanty Chitty, Hadlock, Jeanty Chitty, Hadlock, Jeanty Brenner,...
Page 105 3 Do the following for each measurement you want to take: a From the calculations menu, select the measurement name. b For twins, select Twin A or Twin B, and then select the measurement name. Note The caliper tool may change depending on the measurement selected, but the position remains constant.
Page 106: Small Parts And Msk Calculations
a From the calculations menu, select the measurement name under MCA (Middle Cerebral Artery) or UmbA (Umbilical Artery). b Position the calipers: For S/D, RI, position the first caliper at the peak systolic waveform. Press the SELECT key, and position the second caliper at the end diastole on the waveform.
Page 107: Transcranial Doppler And Orbital Calculations
2 From the calculations menu, select Right or Left. 3 Under d:D Ratio, select Fem Hd (femoral head). 4 Using the touchpad, position and resize the circle. The SELECT key toggles between position and size. Press the SET key. The baseline automatically appears with the left caliper active. 5 Position the caliper.
Page 108 Table 5-3: Transcranial and Orbital calculations Menu Heading TCD and Orb Measurements Results Dist Prox Bifur* Gate Size ACoA* TICA PCAp1 PCAp2 PCoA Siphon Gate Size ECICA Gate Size Prox Dist Gate Size Exam-based calculations...
Page 109 Table 5-3: Transcranial and Orbital calculations (continued) Menu Heading TCD and Orb Measurements Results ECVA Gate Size *Available but not required 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 opthalmic use.
Page 110: Vascular Calculations
Confirm that the system-generated boundary is correct. If you are not satisfied with the trace, obtain a higher quality Doppler spectral trace image, or trace manually. c Press the SET key. d Save the calculation as described in “To save a calculation” on page 74.
Page 111 Table 5-5: Vascular measurements and results Menu Heading Vascular Measurement Calculation Results Prox s (systolic), d (diastolic) s (systolic), d (diastolic) Dist s (systolic), d (diastolic) Bulb s (systolic), d (diastolic) Prox s (systolic), d (diastolic) s (systolic), d (diastolic) Dist s (systolic), d (diastolic)
Page 112: Patient Report
b Using the touchpad, position the caliper at the peak systolic waveform. Press the SELECT key. A second caliper appears. c Using the touchpad, position the second caliper at the end diastole on the waveform. d Save the calculation as described in “To save a calculation”...
Page 113: Tcd Patient Report
To modify the ICA/CCA ratio (Vascular)  In the Ratio list in the vascular patient report, select measurements for the ICA/CCA ratio for both the right and left sides. To adjust the RA pressure (Cardiac)  On the Summary page of the cardiac patient report, select from the RA list. Note Changing the RA pressure from the default 5 affects the RVSP calculation result.
Page 114: Emed And Msk Worksheets
1 On the Anatomy Checklist page in the OB patient report, select the check boxes. 2 Press the TAB key to move between fields and the spacebar to select and deselect items in the checklist. To complete the OB biophysical profile On page 2 of the OB patient report, select values under BPP.
Page 115 To display an MSK worksheet The MSK worksheets have lists from which you can select and a field for entering comments. 1 During or after the exam, press the REPORT key. 2 Select MSK on-screen. 3 Select the worksheet from the Worksheet list. a To display additional pages in the worksheet, select x/x on-screen.
Page 116 Patient report...
Page 117: Chapter 6: Measurement References
Chapter 6: Measurement References Measurement accuracy The measurements provided by the system do not define a specific physiological or anatomical parameter. Rather, the measurements are of a physical property such as distance for evaluation by the clinician. The accuracy values require that you can place the calipers over one pixel. The values do not include acoustic anomalies of the body.
Page 118: Sources Of Measurement Errors
An RMI 413a model phantom with 0.7 dB/cm MHz attenuation was used. Full scale for time implies the total time displayed on the scrolling graphic image. d. FUJIFILM SonoSite special test equipment was used. Table 8: PW Doppler Mode measurement and calculation accuracy and range...
Page 119: Measurement Publications And Terminology
Algorithmic Error is the error introduced by measurements, which are input to higher order calculations. This error is associated with floating-point versus integer-type math, which is subject to errors introduced by rounding versus truncating results for display of a given level of significant digit in the calculation. Measurement publications and terminology The following sections list the publications and terminology used for each calculation result.
Page 120 0.425 0.725 BSA = 0.007184 * Weight * Height Weight = kilograms Height = centimeters Cardiac Index (CI) in l/min/m Oh, J.K., J.B. Seward, and A.J. Tajik. The Echo Manual. 3rd Edition., Philadelphia: Lippincott, Williams, and Wilkins, (2007), 69-70. CI = CO/BSA where: CO = Cardiac Output BSA = Body Surface Area...
Page 121 Delta Pressure: Delta Time (dP:dT) in mmHg/s Otto, C.M. Textbook of Clinical Echocardiography. 2nd ed., W.B. Saunders Company, (2000), 117-118. 32 mmHg/time interval in seconds E:A Ratio in cm/sec E:A = velocity E/velocity A E/Ea Ratio Reynolds, Terry. The Echocardiographer’s Pocket Reference. 2nd ed., School of Cardiac Ultrasound, Arizona Heart Institute, (2000), 225.
Page 122 Heart Rate (HR) in bpm HR = 3 digit value input by user or measured on M Mode and Doppler image in one heart cycle Interventricular Septum (IVS) Fractional Thickening, percent Laurenceau, J. L., M.C. Malergue. The Essentials of Echocardiography. Le Hague: Martinus Nijhoff, (1981), 71. IVSFT = ((IVSS –...
Page 123 h = Height of stacked oval disks making up the LA D1 = Orthogonal minor axis D2 = Orthogonal major axis Left Ventricular End Volumes (Teichholz) in ml Teichholz, L.E., T. Kreulen, M.V. Herman, et. al. “Problems in echocardiographic volume determinations: echocardiographic-angiographic correlations in the presence or absence of asynergy.
Page 124 LVID = Internal Dimension PWT = Posterior Wall Thickness IVST = Interventricular Septal Thickness 1.04 = Specific gravity of the myocardium 0.8 = Correction factor Left Ventricular Volume: Biplane Method in ml Schiller, N.B., P.M. Shah, M. Crawford, et.al. “Recommendations for Quantitation of the Left Ventricle by Two- Dimensional Echocardiography.
Page 125 Oh, J.K., J.B. Seward, and A.J. Tajik. The Echo Manual. 3rd Edition, Philadelphia: Lippincott Williams and Wilkins, (2007), 115. LVDFS = ((LVDD – LVDS)/LVDD) * 100% where: LVDD = Left Ventricle Dimension at Diastole LVDS = Left Ventricle Dimension at Systole Left Ventricular Posterior Wall Fractional Thickening (LVPWFT), percent Laurenceau, J.
Page 126 Va = aliasing velocity Pressure Gradient (PGr) in mmHG Oh, J.K., J.B. Seward, and A.J. Tajik. The Echo Manual. 3rd Edition, Philadelphia: Lippincott, Williams, and Wilkins, (2007), 63-66. PGr = 4 * (Velocity) Peak E Pressure Gradient (E PG) E PG = 4 * PE Peak A Pressure Gradient (A PG) A PG = 4 * PA Peak Pressure Gradient (PGmax)
Page 127 Qp/Qs Oh, J.K., J.B. Seward, and A.J. Tajik. The Echo Manual. 3rd Edition, Boston: Philadelphia: Lippincott Williams and Wilkins, (2007), 70-72. Qp/Qs = SV Qp site/SV Qs site = RVOT SV/LVOT SV where: RVOT SV = RVOT CSA* RVOT VTI = π/4 * RVOT diameter * RVOT VTI LVOT SV = LVOT CSA * LVOT VTI = π/4 * LVOT diameter * LVOT VTI...
Page 128 RA Vol = Right Atrial Volume in ml h = Height of stacked circular disks making up the RA D1 = Orthogonal minor axis Right Ventricular Systolic Pressure (RVSP) in mmHg Oh, J. K., J. B. Seward, and A. J. Tajik. The Echo Manual. 3rd Edition, Philadelphia: Lippincott Williams and Wilkins, (2007), 66.
Page 129: Obstetrical References
Stroke Volume (SV) 2D and M Mode in ml Oh, J.K., J.B. Seward, and A.J. Tajik. The Echo Manual. 2nd Edition, Boston: Little, Brown and Company, (1994), 44. SV = (LVEDV – LVESV) where: SV = Stroke Volume LVEDV = End Diastolic Volume LVEDSV = End Systolic Volume TAPSE Rudski L, Lai W, et al.
Page 130 Results are displayed as month/day/year. EDD = system date + (280 days – AUA in days) Estimated Date of Delivery (EDD) by Last Menstrual Period (LMP) The date entered into the patient information for LMP must precede the current date. Results are displayed as month/day/year.
Page 131: Gestational Age Tables
Journal of Medical Ultrasonics, 23:12 (1996), 885. WARNING The gestational age calculated by your FUJIFILM SonoSite system does not match the age in the aforementioned reference at the 20.0 cm and 30.0 cm abdominal circumference (AC) measurements. The implemented algorithm extrapolates the...
Page 132 Crown Rump Length (CRL) Hadlock, F., et al. “Fetal Crown-Rump Length: Re-evaluation of Relation to Menstrual Age (5-18 weeks) with High-Resolution, Real-Time Ultrasound. ” Radiology, 182: (February 1992), 501-505. Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-Verlag, (1986), 439. Osaka University.
Page 133: Growth Analysis Tables
Head Circumference (HC) Chitty, L. S. and D.G. Altman. “New charts for ultrasound dating of pregnancy. ” Ultrasound in Obstetrics and Gynecology 10: (1997), 174-191, Table 5, 182. Hadlock, F., et al. “Estimating Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth Parameters. ” Radiology, 152: (1984), 497-501.
Page 134 Biparietal Diameter (BPD) Chitty, Lyn S. et al. “Charts of Fetal Size: 2. Head Measurements. ” British Journal of Obstetrics and Gynaecology 101: (January 1994), 43, Appendix: BPD-Outer-Inner. Hadlock, F., et al. “Estimating Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth Parameters. ” Radiology, 152: (1984), 497-501.
Page 135: Ratio Calculations
Hadlock, F., et al. “Estimating Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth Parameters. ” Radiology, 152: (1984), 497-501. Jeanty P, E. Cousaert, and F. Cantraine. “A longitudinal study of Fetal Head Biometry. ” American J of Perinatology, 1: (January 1984), 118-128, Table 3. (Also published in Hansmann, Hackeloer, Staudach, Wittman.
Page 136 where: A = velocity cursor + B = velocity cursor x Acceleration Index (ACC) Zwiebel, W.J. Introduction to Vascular Ultrasonography, 4th ed., W.B. Saunders Company, (2000), 52. ACC = abs (delta velocity/delta time) Elapsed Time (ET) ET = time between velocity cursors in milliseconds Hip Angle/d:D Ratio Graf, R.
Page 137 Pressure Gradient (PGr) in mmHG Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. 2nd ed., Lippincott, Williams, and Wilkins, (1999), 64. 4 * (Velocity) Peak E Pressure Gradient (E PG) E PG = 4 * PE Peak A Pressure Gradient (A PG) A PG = 4 * PA2 Peak Pressure Gradient (PGmax) PGmax = 4 * PV2...
Page 138 TAM = mean (mean Trace) Time Averaged Peak (TAP) in cm/s TAP = peak (peak Trace) Volume (Vol) Beyer, W.H. Standard Mathematical Tables, 28th ed., CRC Press, Boca Raton, FL, (1987), 131. Volume cm = (4/3) * π * Length/2 * Width/2 * Height/2 Volume Flow (VF) in ml/m Allan, Paul L.
Page 139: Chapter 7: Troubleshooting And Maintenance
Troubleshooting If you encounter difficulty with the system, use the following list to help troubleshoot the problem. If the problem persists, contact FUJIFILM SonoSite Technical Support. See “Getting help” on page 2.
Page 140: Software Licensing
Delete any unwanted images or clips from the patient exam. Software licensing FUJIFILM SonoSite software is controlled by a license key. After you install new software, the system prompts you for a license key. You must obtain one key for each system or transducer that uses the software.
Page 141: Maintenance
To obtain a license key for your software, contact FUJIFILM SonoSite Technical Support. See “Getting help” page 2. You need to provide the following information. Refer to “System Information setup” on page 34. System Software Transducer Software Name of person installing the upgrade...
Page 142 Maintenance...
Page 143: Chapter 8: Cleaning And Disinfecting
(PPE), such as protective eyewear and gloves. Inspect the system to determine that it is free of any unacceptable deterioration, such as corrosion, discoloration, pitting, or cracked seals. If damage is evident, discontinue use, and contact FUJIFILM SonoSite or your local representative.
Page 144: Determining The Required Cleaning And Disinfecting Level
Do not allow cleaning solution or disinfectant into the system connectors, or Cautions transducer connector. Do not use strong solvents such as thinner or benzene, or abrasive cleansers, since these will damage the exterior surfaces. Use only FUJIFILM SonoSite recommended cleaners or disinfectants. Determining the required cleaning and disinfecting level Note Be aware that you must perform both a cleaning as well as a disinfection for each component.
Page 145: Option A: Semi-Critical Cleaning Of System And Transducer And Disinfecting Of System And Transducer (Semi-Critical Uses)
Table 8-1: Cleaning and disinfecting guide (continued) Did any part of the system or transducer come in contact with broken skin, blood, or bodily fluids? Option B Did not come in contact with “Option B: Non-critical cleaning and low-level disinfecting of system and transducer (non-critical broken skin, blood, or bodily fluid uses)”...
Page 146 This can damage the transducer and void the warranty. Use only FUJIFILM SonoSite recommended cleaners and disinfectants. Using a non- recommended disinfecting solution or incorrect solution strength can damage the System and transducer and void the warranty. Follow the disinfectant manufacturer’s recommendations for solutions strengths.
Page 147 10 Examine the transducer and cable for damage, such as cracks or splitting where fluid can enter. If damage is evident, discontinue use of the transducer, and contact FUJIFILM SonoSite or your local representative. Part 2 of 2: High-level disinfecting of transducer for semi-critical contact Be sure to use the appropriate Personal Protective Equipment (PPE) whenever...
Page 148 3 Dry with a sterile lint-free cloth, or allow to air dry completely in a well-ventilated area. 4 Examine the transducer and cable for damage, such as cracks or splitting where fluid can enter. If damage is evident, discontinue use of the transducer, and contact FUJIFILM SonoSite or your local representative.
Page 149: Option B: Non-Critical Cleaning And Low-Level Disinfecting Of System And Transducer (Non-Critical Uses)
Doing so may cause solution to leak into the system, damaging it and voiding the warranty. Use only FUJIFILM SonoSite recommended cleaners and disinfectants. Using a non- recommended disinfecting solution or incorrect solution strength can damage the System and transducer and void the warranty. Follow the disinfectant manufacturer’s recommendations for solutions strengths.
Page 150 To clean the system and transducer 1 Turn off the system by pressing the Power button. 2 Unplug the power cord from the outlet. 3 Disconnect the transducer from the system. 4 Remove the transducer sheath, if applicable. 5 Use either a pre-moistened wipe or a soft cloth dampened with cleaner and disinfectant. Table 8-4, “Cleaner transducer compatibility and wet contact time”...
Page 151: Cleaning And Disinfecting The Battery
Cleaning and disinfecting the battery Caution To avoid damaging the battery, do not allow cleaning solution or disinfectant to come in contact with the battery terminals. To clean and disinfect a battery (wipe method) 1 Remove the battery from the system. 2 Clean the surface using a soft cloth lightly dampened in a mild soap or detergent cleaning solution.
Page 152 3 Clean the surface using a soft cloth lightly dampened in a mild soap, cleaning solution, or pre-moistened wipe. Apply the solution to the cloth rather than the surface. 4 Wipe the surfaces with a FUJIFILM SonoSite Approved cleaner or disinfectant 5 Air dry or dry with a clean cloth.
Page 153: Chapter 9: Safety
Chapter 9: Safety This chapter contains ergonomic, electrical, and clinical safety information required by regulatory agencies. The information applies to the ultrasound system, transducer, accessories, and peripherals. This chapter also defines labeling symbols, specifications, and standards. For safety information regarding the ALARA principle and acoustic output, see Chapter 10, “Acoustic Output.
Page 154: Position The System
3. Smith, C.S., G.W. Wolf, G. Y. Xie, and M. D. Smith. “Musculoskeletal Pain in Cardiac Ultrasonographers: Results of a Random Survey. ” Journal of American Society of Echocardiography. (May1997), 357-362. 4. Wihlidal, L.M. and S. Kumar. “An Injury Profile of Practicing Diagnostic Medical Sonographers in Alberta. ” International Journal of Industrial Ergonomics.
Page 155: Take Breaks, Exercise, And Vary Activities
Keep your wrist in a straight position. Take breaks, exercise, and vary activities Minimizing scanning time and taking breaks can effectively allow your body to recover from physical activity and help you avoid MSDs. Some ultrasound tasks may require longer or more frequent breaks. However, simply changing tasks can help some muscle groups relax while others remain or become active.
Page 156 To avoid the risk of electrical shock: WARNING This equipment must be connected only to a supply mains with protective earth. Use only properly grounded equipment. Shock hazards exist if the power supply is not properly grounded. Grounding reliability can be achieved only when equipment is connected to a receptacle marked “Hospital Only”...
Page 157 Do not use the system if an error message appears on the image display: note the Cautions error code; call FUJIFILM SonoSite or your local representative; turn off the system by pressing and holding the power key until the system powers down.
Page 158: Electrical Safety Classification
Electrical safety classification Class I equipment The ultrasound system is classified as Class I equipment when pow- ered from the external power supply or mounted on the stand because the external power supply is a Class 1 protectively earthed power supply. The stand has no protective earth.
Page 159: Battery Safety
Do not connect the battery to an electrical power outlet. Do not continue recharging the battery if it does not recharge after two successive six hour charging cycles. Do not ship a damaged battery without instructions from FUJIFILM SonoSite Technical Support. Refer to “Getting help”...
Page 160: Clinical Safety
If the battery emits an odor or heat, is deformed or discolored, or in any way appears abnormal during use, recharging or storage, immediately remove it and stop using it. If you have any questions about the battery, consult FUJIFILM SonoSite or your local representative.
Page 161: Hazardous Materials
To avoid injury or reduce the risk of infection to the patient, observe the WARNINGS following: Follow Universal Precautions when inserting and maintaining a medical device for interventional and intraoperative procedures. Appropriate training in interventional and intraoperative procedures as dictated by current relevant medical practices as well as in proper operation of the ultrasound system and transducer is required.
Page 162: Electromagnetic Compatibility
Connection of accessories and peripherals not recommended by FUJIFILM SonoSite could result in malfunctioning of your ultrasound system or other medical electrical devices in the area. Contact FUJIFILM SonoSite or your local representative for a list of accessories and peripherals available from or recommended by FUJIFILM SonoSite.
Page 163: Wireless Transmission
Wireless transmission The SonoSite Edge II ultrasound system contains an IEEE 802.11 transmitter that utilizes the ISM frequency bands from 2.412 to 2.484GHz and implements two methods of transmission: IEEE 802.11b with Complimentary Code Keying (CCK), Differential Quarternary Phase Shift Keying (DQPSK), and Differential Binary Phase Shift Keying (DBPSK) at 16 dB IEEE 802.11g with Orthogonal Frequency Division Multiplexing (ODFM) at 13 dBm...
Page 164 WARNING Unless following ESD precautionary procedures, do not connect to or touch (with body or hand-held tools) pins (contacts) of connectors that have the ESD Sensitive Devices label: Electrostatic Sensitive Devices Label Pins (contacts) on transducer and back of TTC connector Pins (contacts) on the back of the Triple Transducer Connect (TTC) Pins (contacts)
Page 165: Separation Distance
Compatible accessories and peripherals FUJIFILM SonoSite has tested the SonoSite Edge II Ultrasound System with the following accessories and peripherals and has demonstrated compliance to the requirements of IEC60601-1-2:2007. You may use these FUJIFILM SonoSite accessories and third-party peripherals with the SonoSite Edge II ultrasound system.
Page 166 Use of the accessories with medical systems other than the SonoSite Edge II WARNINGS ultrasound system may result in increased emissions or decreased immunity of the medical system. Use of accessories other than those specified may result in increased emissions or decreased immunity of the ultrasound system.
Page 167 Table 9-2: Accessories and peripherals compatible with SonoSite Edge II ultrasound system (continued) Description Maximum Cable Length Color printer — Color printer power cable 3.3 ft/1 m Color printer video cable 6 ft/1.8 m ECG lead wires 24 in/0.6 m ECG module 5.8 ft/1.8 m...
Page 168: Manufacturer's Declaration
Emissions Test Compliance Electromagnetic Environment RF emissions Group 1 The SonoSite Edge II ultrasound ClSPR 11 system uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
Page 169 (>95% dip in U ) for interruptions and hospital environment. If the user 0.5 cycle 0.5 cycle voltage of the FUJIFILM SonoSite 40% U 40% U variations on ultrasound system requires (60% dip in U ) for 5 (60% dip in U...
Page 170 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the FUJIFILM SonoSite ultrasound system is used exceeds the applicable RF compliance level above, the FUJIFILM SonoSite ultrasound system should be observed to verify normal operation.
Page 171: Labeling Symbols
The SonoSite Edge II ultrasound system complies with the essential performance requirements specified in IEC 60601-1-2 and IEC 60601-2-37. Results of immunity testing show that the SonoSite Edge II ultrasound system meets these requirements and is free from the following: Noise on a waveform or artifacts or distortion in an image or error of a displayed numerical value that...
Page 172 Table 9-5: Labels and symbols (continued) Symbol Definition Class 1 device requiring verification by the Notified Body of sterilization or measurement features, or to a Class IIa, IIb, or III device requiring verification or auditing by the Notified Body to applicable Annex(es) of 93/42/EEC Attention, refer to the user guide Device complies with relevant Australian regulations for electronic devices.
Page 173 Table 9-5: Labels and symbols (continued) Symbol Definition Date of manufacture Manufacturer Direct Current (DC) Do not get wet. Do not stack over 2 high. Do not stack over 5 high. Do not stack over 10 high. Electrostatic sensitive devices Device complies with relevant FCC regulations for electronic devices.
Page 174 Table 9-5: Labels and symbols (continued) Symbol Definition Sterilized using irradiation STERILE R Sterilized using ethylene oxide STERILE EO Device emits a static (DC) magnetic field. Non-ionizing radiation Paper recycle Serial number type of control number Temperature limitation Atmospheric pressure limitation Humidity limitation Submersible.
Page 175 Chinese national standards for many products sold in the People’s Republic of China. WARNING: WARNING: Connect Only Connect Only Accessories and Peripherals Accessories and Recommended by FUJIFILM SonoSite Peripherals Recommended by SonoSite Follow instructions for use. Manufacturer, or Manufacturer and date of manufacture Authorized representative in the European Community...
Page 176: Specifications
Specifications Dimensions System Length: 13 in. (33 cm) Width: 12.4 in. (31.5 cm) Height: 2.5 in. (6.3 cm) Weight: 11.35 lbs. (4.6 kg) with the TEExi transducer and battery installed Display Length: 9.7 in. (24.6 cm) Height: 7.3 in. (18.5 cm) Diagonal: 12.1 in.
Page 177: Electrical Specifications
Electrical specifications Power Supply Input: 100-240 VAC, 50/60 Hz, 2.0 A Max @ 100 VAC Power Supply Output #1: 15 VDC, 5.0 A Max Power Supply Output #2: 12 VDC, 2.3 A Max Combined output not exceeding 75 watts. Battery specifications The battery comprises six lithium-ion cells plus electronics, a temperature sensor, and battery contacts.
Page 178: Standards
Standards Electromechanical safety standards Table 9-6: Electromechanical safety standards Standard Description AAMI ES60601-1:2005 Medical electrical equipment, Part 1: General requirements for basic safety and + C1(2009) + A2(2010) essential performance (3 edition plus Corrigendum 1 and Amendment A2) CSA C22.2 No. 60601- Medical electrical equipment –...
Page 179: Biocompatibility Standards
Biocompatibility standards AAMI/ANSI/ISO 10993-1:2009, Biological evaluation of medical devices—Part 1: Evaluation and testing (2009). AAMI/ANSI/ISO 10993-5, Biological evaluation of medical devices—Part 5: Tests for In Vitro cytotoxicity (2009). AAMI/ANSI/ISO 10993-10, Biological evaluation of medical devices—Part 10: Tests for irritation and delayed- type hypersensitivity (2002).
Page 180 Standards...
Page 181: Chapter 10: Acoustic Output
Chapter 10: Acoustic Output This chapter contains safety information required by regulatory agencies pertaining to acoustic output. The information applies to the ultrasound system, transducer, accessories, and peripherals. ALARA principle ALARA is the guiding principle for the use of diagnostic ultrasound. Sonographers and other qualified ultrasound users, using good judgment and insight, determine the exposure that is “as low as reasonably achievable.
Page 182: Direct Controls
The system has been designed to ensure that temperature at the face of the transducer will not exceed the limits established in Section 42 of EN 60601-2-37: Particular requirement for the safety of ultrasound medical diagnostic and monitoring equipment. See “Transducer surface temperature rise”...
Page 183: Guidelines For Reducing Mi And Ti
Reverberations Comet tails For more information on detecting and interpreting acoustic artifacts, refer to the following reference: Kremkau, Frederick W. Diagnostic Ultrasound: Principles and Instruments. 7th ed., W.B. Saunders Company, (Oct. 17, 2005). Guidelines for reducing MI and TI The following are general guidelines for reducing MI or TI. If multiple parameters are given, the best results may be achieved by minimizing these parameters simultaneously.
Page 184 Table 10-1: Guidelines for reducing MI (continued) Transducer Depth L25x L38xi standard/armored P10x rP19x standard/armored TEExi Decrease or lower setting of parameter to reduce MI. increase or raise setting of parameter to reduce MI. Table 10-2: Guidelines for reducing TI CPD Settings Transducer PW Settings...
Page 185 Table 10-2: Guidelines for reducing TI (continued) CPD Settings Transducer PW Settings Depth Optimize Width Height Depth HFL50x (Depth) HSL25x (PRF) ICTx Exam Gyn (PRF) L25x (PRF) L38xi standard/ armored (Sample volume zone or size) P10x (PRF) rP19x standard/ armored (Depth) TEExi (PRF)
Page 186: Output Display
Output display The system meets the AIUM output display standard for MI and TI. See “Related guidance documents” page 182. Table 10-3 indicates for each transducer and operating mode when either the TI or MI is greater than or equal to a value of 1.0, thus requiring display. Table 10-3: TI or MI ...
Page 187: Mi And Ti Output Display Accuracy
ALARA principle, the user selects an appropriate TI based on the specific exam being performed. FUJIFILM SonoSite provides a copy of AIUM Medical Ultrasound Safety, which contains guidance on determining which TI is appropriate. Refer to “Related guidance documents”...
Page 188: Related Guidance Documents
having an acoustic output that is representative of the nominal expected acoustic output for all transducer/ system combinations that might occur. Of course every transducer/system combination has its own unique characteristic acoustic output, and will not match the nominal output on which the display estimates are based.
Page 189: Acoustic Output Measurement
Table 10-4: Transducer Surface Temperature Rise, External Use (°C) Test C11x rC60xi HFL38xi HFL50x HSL25x L25x L38xi P10x rP19x Still air 14.2 15.0 12.4 10.7 17.5 16.1 12.5 16.0 14.9 Simulated Table 10-5: Transducer Surface Temperature Rise, Internal Use (°C) Test ICTx TEExi...
Page 190 where: In Situ = In Situ intensity value Water = Water intensity value e = 2.7183 a = attenuation factor (dB/cm MHz) Attenuation factor (a) for various tissue types are given below: brain = 0.53 heart = 0.66 kidney = 0.79 liver = 0.43 muscle = 0.55 l = skinline to measurement depth in cm...
Page 191: Tissue Models And Equipment Survey
Tissue models and equipment survey Tissue models are necessary to estimate attenuation and acoustic exposure levels In Situ from measurements of acoustic output made in water. Currently, available models may be limited in their accuracy because of varying tissue paths during diagnostic ultrasound exposures and uncertainties in the acoustic properties of soft tissues.
Page 192: Acoustic Output Tables
Acoustic output tables Table 10-6 through Table 10-51 indicate the acoustic output for the system and transducer combinations with a TI or MI equal to or greater than one. These tables are organized by transducer model and imaging mode. For a definition of terms used in the tables, refer to “Terms used in the acoustic output tables”...
Page 193 Table 10-6: Transducer Model: C11x Operating Mode: PW Doppler Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — (MPa) (mW) — 24.6 21.7 min of [W (mW) — TA.3 (cm) — (cm) — (cm) 1.70 z@PII...
Page 194 Table 10-7: Transducer Model: rC60xi standard/armored Operating Mode: 2D Non-scan Index Label Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — — (MPa) 2.31 (mW) — — min of [W (mW) — TA.3 (cm) — (cm) — (cm) —...
Page 195 Table 10-8: Transducer Model: rC60xi standard/armored Operating Mode: M Mode Non-scan Index Label Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — (MPa) 2.18 (mW) — — 69.8 min of [W (mW) — TA.3 (cm) — (cm) —...
Page 196 Table 10-9: Transducer Model: rC60xi standard/armored Operating Mode: CPD/Color Non-scan Index Label Scan Non-scan 1 A >1 aprt aprt Global Maximum Index Value — — — (MPa) 2.21 (mW) 107.5 — — min of [W (mW) — TA.3 (cm) — (cm) —...
Page 197 Table 10-10: Transducer Model: rC60xi standard/armored Operating Mode: PW Doppler Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — (MPa) 1.73 (mW) — — 291.8 min of [W (mW) 187.5 TA.3 (cm) (cm) (cm) 3.60 z@PII...
Page 198 Table 10-11: Transducer Model: HFL38xi Operating Mode: 2D Non-scan Index Label Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — — (MPa) 3.05 (mW) — — min of [W (mW) — TA.3 (cm) — (cm) — (cm) —...
Page 199 Table 10-12: Transducer Model: HFL38xi Operating Mode: M Mode Non-scan Index Label Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — (MPa) 3.14 (mW) — min of [W (mW) — TA.3 (cm) — (cm) — (cm) z@PII (cm) .3max (cm)
Page 200 Table 10-13: Transducer Model: HFL38xi Operating Mode: CPD/Color Non-scan Index Label Non- Scan 1 scan >1 aprt aprt Global Maximum Index Value — — — (MPa) 3.05 (mW) — — min of [W (mW) — TA.3 (cm) — (cm) — (cm) —...
Page 201 Table 10-14: Transducer Model: HFL38xi Operating Mode: PW Doppler Non-scan Index Label Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — (MPa) 2.69 (mW) — 47.7 47.7 min of [W (mW) — TA.3 (cm) — (cm) — (cm) 1.10 z@PII...
Page 202 Table 10-15: Transducer Model: HFL50x Operating Mode: 2D Non-scan Index Label Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — — (MPa) 3.051 (mW) — — min of [W (mW) — TA.3 (cm) — (cm) — (cm) —...
Page 203 Table 10-16: Transducer Model: HFL50x Operating Mode: M Mode Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — (MPa) 3.14 (mW) — min of [W (mW) — TA.3 (cm) — (cm) — (cm) (cm) (MHz) 6.75...
Page 204 Table 10-17: Transducer Model: HFL50x Operating Mode: CPD/Color Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — — (MPa) 3.05 (mW) — — min of [W (mW) — TA.3 (cm) — (cm) — (cm) —...
Page 205 Table 10-18: Transducer Model: HFL50x Operating Mode: PW Doppler Non-scan Index Label Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — (MPa) 2.69 (mW) — 42.6 42.6 min of [W (mW) — TA.3 (cm) — (cm) — (cm) (cm) 0.33...
Page 206 Table 10-19: Transducer Model: HSL25x Operating Mode: 2D Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — — (MPa) 2.87 (mW) — — min of [W (mW) — TA.3 (cm) — (cm) — (cm) —...
Page 207 Table 10-20: Transducer Model: HSL25x Operating Mode: CPD/Color Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — — (MPa) 2.35 (mW) — — min of [W (mW) — TA.3 (cm) — (cm) — (cm) —...
Page 208 Table 10-21: Transducer Model: HSL25x Operating Mode: PW Doppler Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — (MPa) (mW) — 28.1 min of [W (mW) — TA.3 (cm) — (cm) — (cm) 0.75 z@PII (cm)
Page 209 Table 10-22: Transducer Model: HSL25x Ophthalmic Use Operating Mode: 2D Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value 0.17 0.02 — — — (MPa) 0.47 (mW) 0.70 — — min of [W (mW) — TA.3 (cm) —...
Page 210 Table 10-23: Transducer Model: HSL25x Ophthalmic Use Operating Mode: M Mode Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value 0.17 — 0.01 — 0.02 (MPa) 0.47 (mW) — 0.45 0.45 min of [W (mW) —...
Page 211 Table 10-24: Transducer Model: HSL25x Ophthalmic Use Operating Mode: CPD/Color Non-scan Index Label M.I. Scan Non-scan 1 A >1 aprt aprt Global Maximum Index Value 0.17 0.06 — — — (MPa) 0.42 (mW) — — min of [W (mW) — TA.3 (cm) —...
Page 212 Table 10-25: Transducer Model: HSL25x Ophthalmic Use Operating Mode: PW Doppler Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value 0.18 — 0.12 — 0.21 (MPa) 0.44 (mW) — min of [W (mW) — TA.3 (cm) —...
Page 213 Table 10-26: Transducer Model: ICTx Operating Mode: PW Doppler Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — (MPa) (mW) — 16.348 min of [W (mW) — TA.3 (cm) — (cm) — (cm) (cm) 0.192 (MHz)
Page 214 Table 10-27: Transducer Model: L25x Operating Mode: 2D Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — — (MPa) 2.87 (mW) — — min of [W (mW) — TA.3 (cm) — (cm) — (cm) —...
Page 215 Table 10-28: Transducer Model: L25x Operating Mode: CPD/Color Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — — (MPa) 2.35 (mW) — — min of [W (mW) — TA.3 (cm) — (cm) — (cm) —...
Page 216 Table 10-29: Transducer Model: L25x Operating Mode: PW Doppler Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — (MPa) (mW) — 32.1 min of [W (mW) — TA.3 (cm) — (cm) — (cm) 0.75 (cm) 0.30...
Page 217 Table 10-30: Transducer Model: L25x Ophthalmic Use Operating Mode: 2D Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value 0.17 0.02 — — — (MPa) 0.47 (mW) 0.70 — — min of [W (mW) — TA.3 (cm) —...
Page 218 Table 10-31: Transducer Model: L25x Ophthalmic Use Operating Mode: M Mode Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value 0.17 — 0.01 — 0.02 (MPa) 0.47 (mW) — 0.45 0.45 min of [W (mW) —...
Page 219 Table 10-32: Transducer Model: L25x Ophthalmic Use Operating Mode: CPD/Color Non-scan Index Label M.I. Scan Non-scan 1 A >1 aprt aprt Global Maximum Index Value 0.17 0.06 — — — (MPa) 0.42 (mW) — — min of [W (mW) — TA.3 (cm) —...
Page 220 Table 10-33: Transducer Model: L25xOphthalmic Use Operating Mode: PW Doppler Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value 0.18 — 0.12 — 0.21 (MPa) 0.44 (mW) — min of [W (mW) — TA.3 (cm) —...
Page 221 Table 10-34: Transducer Model: L38xi standard/armored Operating Mode: 2D Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — — (MPa) 3.30 (mW) — — min of [W (mW) — TA.3 (cm) — (cm) —...
Page 222 Table 10-35: Transducer Model: L38xi standard/armored Operating Mode: M Mode Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — (MPa) 3.54 (mW) — 37.1 min of [W (mW) — TA.3 (cm) — (cm) —...
Page 223 Table 10-36: Transducer Model: L38xi standard/armored Operating Mode: CPD/Color Non-scan Index Label M.I. Scan Non-scan 1 A >1 aprt aprt Global Maximum Index Value — — — (MPa) 3.30 (mW) 49.0 — — min of [W (mW) — TA.3 (cm) —...
Page 224 Table 10-37: Transducer Model: L38xi standard/armored Operating Mode: PW Doppler Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — (MPa) 2.59 (mW) — 114.5 114.5 min of [W (mW) — TA.3 (cm) — (cm) —...
Page 225 Table 10-38: Transducer Model: P10x Operating Mode: CPD/Color Non-scan Index Label M.I. Scan Non-scan 1 A >1 aprt aprt Global Maximum Index Value — — — (MPa) (mW) — — 42.2 min of [W (mW) — TA.3 (cm) — (cm) —...
Page 226 Table 10-39: Transducer Model: P10x Operating Mode: PW Doppler Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — (MPa) 1.92 (mW) — 34.4 31.9 26.9 min of [W (mW) — TA.3 (cm) — (cm) —...
Page 227 Table 10-40: Transducer Model: P10x Operating Mode: CW Doppler Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — (MPa) (mW) — 34.8 25.7 min of [W (mW) — TA.3 (cm) — (cm) — (cm) 0.70 z@PII...
Page 228 Table 10-41: Transducer Model: rP19x standard/armored Operating Mode: 2D Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — — (MPa) 2.10 (mW) 96.1 — — 177.8 min of [W (mW) — TA.3 (cm) —...
Page 229 Table 10-42: Transducer Model: rP19x standard/armored Operating Mode: M Mode Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — (MPa) 2.10 (mW) — 55.0 62.1 min of [W (mW) — TA.3 (cm) — (cm) —...
Page 230 Table 10-43: Transducer Model: rP19x standard/armored Operating Mode: CPD/Color Non-scan Index Label M.I. Scan Non-scan 1 A >1 aprt aprt Global Maximum Index Value — — — (MPa) 2.10 (mW) 115.6 — — 170.5 min of (mW) — TA.3 (cm) —...
Page 231 Table 10-44: Transducer Model: rP19x standard/armored Operating Mode: PW Doppler Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — (MPa) 1.94 (mW) — — 240.2 251.1 min of [W (mW) 173.7 TA.3 (cm) (cm) (cm) 3.35...
Page 232 Table 10-45: Transducer Model: rP19x standard/armored Operating Mode: CW Doppler Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — (MPa) (mW) — 125.4 125.4 125.4 min of [W (mW) — TA.3 (cm) — (cm) —...
Page 233 Table 10-46: Transducer Model: rP19x Orbital Use standard/armored Operating Mode: 2D Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value 0.17 0.03 — — — 0.07 (MPa) 0.25 (mW) — — min of [W (mW) —...
Page 234 Table 10-47: Transducer Model: rP19x Orbital Use standard/armored Operating Mode: M Mode Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value 0.17 — — 0.01 0.02 0.02 (MPa) 0.25 (mW) — — 1.34 1.34 min of [W (mW) TA.3 (cm)
Page 235 Table 10-48: Transducer Model: rP19x Orbital Use standard/armored Operating Mode: CPD/Color Non-scan Index Label M.I. Scan Non-scan 1 A >1 aprt aprt Global Maximum Index Value 0.17 0.09 — — — 0.23 (MPa) 0.25 (mW) — — 15.5 min of (mW) —...
Page 236 Table 10-49: Transducer Model: rP19x Orbital Use standard/armored Operating Mode: PW Doppler Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value 0.18 — — 0.27 0.59 0.57 (MPa) 0.27 (mW) — — 35.3 37.4 min of [W (mW) 25.3 TA.3...
Page 237 Table 10-50: Transducer Model: TEExi Operating Mode: PW Doppler Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — (MPa) (mW) — 35.8 min of [W (mW) — TA.3 (cm) — (cm) — (cm) 2.57 z@PII (cm)
Page 238 Table 10-51: Transducer Model: TEExi Operating Mode: CW Doppler Non-scan Index Label M.I. Scan Non-scan 1 >1 aprt aprt Global Maximum Index Value — — (MPa) (mW) — 34.4 min of [W (mW) — TA.3 (cm) — (cm) — (cm) z@PII (cm) .3max...
Page 239: Terms Used In The Acoustic Output Tables
Terms used in the acoustic output tables Term Definition Ispta.3 Derated spatial peak, temporal average intensity in units of milliwatts/cm TI type Applicable thermal index for the transducer, imaging mode, and exam type. TI value Thermal index value for the transducer, imaging mode, and exam type. Mechanical index.
Page 240: Acoustic Measurement Precision And Uncertainty
Term Definition deq(z) Equivalent beam diameter as a function of axial distance z, and is equal to       Wo      z     , where I (z) is the temporal-average intensity as a function of z in centimeters.
Page 241 Quantity Precision (% of standard deviation) Uncertainty (95% confidence) 3.2% +13.47 to -17.5% Acoustic output tables...
Page 242 Acoustic output tables...
Page 243: Terms
Glossary Terms For ultrasound terms not included in this glossary, refer to Recommended Ultrasound Terminology, Third Edition, published in 2011 by the American Institute of Ultrasound in Medicine (AIUM). as low as reasonably The guiding principle of ultrasound use, which states that you should keep achievable (ALARA) patient exposure to ultrasound energy as low as reasonably achievable for diagnostic results.
Page 244 SonoHD2™ Imaging A subset of the 2D imaging mode in which the 2D image is enhanced by Technology reducing speckle noise artifact at tissue margins and improving contrast resolution by reducing artifacts and improving visualization of texture patterns within the image. SonoMB technology, A subset of the 2D imaging mode in which the 2D image is enhanced by Steep Needle Profiling...
Page 245: Abbreviations
Abbreviations Table 11-1: Abbreviations in user interface Abbreviation Definition +/× “+” Caliper/”×” Caliper Ratio “A” Wave Peak Velocity A PG “A” Wave Peak Pressure Gradient A2Cd Apical 2 Chamber diastolic A2Cs Apical 2 Chamber systolic A4Cd Apical 4 Chamber diastolic A4Cs Apical 4 Chamber systolic Abdominal Aortic Aneurysm...
Page 246 Table 11-1: Abbreviations in user interface (continued) Abbreviation Definition Aorta Aortic Root Diameter Apical Apical View APTD Anteroposterior Trunk Diameter Acceleration (Deceleration) Time Average Ultrasound Age Calculated by averaging the individual ultrasound ages for the fetal biometry measurements performed during the exam. The measurements used to determine the AUA are based on the selected OB calculation authors.
Page 247 Table 11-1: Abbreviations in user interface (continued) Abbreviation Definition Continuous Wave Doppler CxLen Cervix Length Diameter D Apical Distance Apical DCCA Distal Common Carotid Artery DECA Distal External Carotid Artery DICA Distal Internal Carotid Artery Dist Distal dP:dT Delta Pressure: Delta Time “E”...
Page 248 Table 11-1: Abbreviations in user interface (continued) Abbreviation Definition Estimated Fetal Weight Calculated from the measurements performed during the exam. The measurements used to determine EFW are defined by the currently selected EFW calculation author. Endo Endocardial Epicardial EPSS “E” Point Septal Separation Estab.
Page 249 Table 11-1: Abbreviations in user interface (continued) Abbreviation Definition Humerus Length Heart Rate Internal Carotid Artery Inferior Vena Cava IVRT Iso Volumic Relaxation Time Interventricular Septum IVSd Interventricular Septum Diastolic IVSFT Interventricular Septum Fractional Thickening IVSs Interventricular Septum Systolic Left Atrium LA/Ao Left Atrium/Aorta Ratio LAT F...
Page 250 Table 11-1: Abbreviations in user interface (continued) Abbreviation Definition LVDFS Left Ventricular Dimension Fractional Shortening LVDs Left Ventricular Dimension Systolic LVEDV Left Ventricular End Diastolic Volume LVESV Left Ventricular End Systolic Volume LVET Left Ventricular Ejection Time Left Ventricular Opacification LVOT Left Ventricular Outflow Tract LVOT Area...
Page 251 Table 11-1: Abbreviations in user interface (continued) Abbreviation Definition Musculoskeletal Mitral Valve MV Area Mitral Valve Area MV Regurgitant Fraction Mitral Valve Regurgitant Fraction MV Regurgitant Volume Mitral Valve Regurgitant Volume MV/VTI Mitral Valve/Velocity Time Integral Mitral Valve Area MV ERO Mitral Valve Effective Regurgitant Orifice MV PISA Area Mitral Valve Proximal Iso Velocity Surface Area...
Page 252 Table 11-1: Abbreviations in user interface (continued) Abbreviation Definition PGmean Mean Pressure Gradient Pressure Gradient Pressure Half Time Pulsatility Index PICA Proximal Internal Carotid Artery PISA Proximal Isovelocity Surface Area Plaq Plaque POST F Posterior Far POST N Posterior Near Pulse Repetition Frequency Prox Proximal...
Page 253 Table 11-1: Abbreviations in user interface (continued) Abbreviation Definition RVWd Right Ventricular Free Wall Diastolic RVWs Right Ventricular Free Wall Systolic SonoHD technology Systolic/Diastolic Ratio Stroke Index Siphon Siphon (internal carotid artery) Submandibular Small Parts Suboccipital Superficial Stroke Volume Time Average Mean Time Average Peak TAPSE M Mode distance measurement of systolic excursion of the right ventricle...
Page 254 Table 11-1: Abbreviations in user interface (continued) Abbreviation Definition Ultrasound Age Calculated on the mean measurements taken for a particular fetal biometry. Umb A Umbilical Artery Vertebral Artery VArty Vertebral Artery Vascular Venous Volume Flow Vmax Peak Velocity Vmean Mean Velocity Volume Velocity Time Integral Yolk Sac...
Page 256 P20516-02 *P20516-02*...

FujiFilm SonoSite Edge II User Manual

Chapter 1: Introduction

Chapter 2: Getting Started

Chapter 3: System Setup

Chapter 4: Imaging

Chapter 5: Measurements and Calculations

Chapter 6: Measurement References

Chapter 7: Troubleshooting and Maintenance

Chapter 8: Cleaning and Disinfecting

Chapter 9: Safety

Chapter 10: Acoustic Output

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