SONIX ULTRASOUND SYSTEM

USER MANUAL
Ultrasonix Medical Corporation

SONIX Series Ultrasound System

Ultrasonix Medical Corporation

301 – 3480 Gilmore Way
Burnaby, BC V5G 4Y1
Canada

www.ultrasonix.com

1.866.437.9508

© 2006 Ultrasonix Medical Corporation

SUM – 001, Revision C, March 20, 2006
All rights reserved. Printed in Canada.

US Patents 6,911,008 - 6,558,326 - 6,325,759

SONIX User Manual SUM – 001, Revision C

TABLE OF CONTENTS

CHAPTER 1 - INTRODUCTION .................................................................................................................. 1

1.0 AUDIENCE ....................................................................................................................................................... 1
1.1 CONVENTIONS................................................................................................................................................ 1
1.2 UPDATES ......................................................................................................................................................... 1
1.3 LICENSE AGREEMENTS................................................................................................................................. 2
1.4 TRADEMARKS AND PATENTS ....................................................................................................................... 2

CHAPTER 2 - SONIX INTRODUCTION ...................................................................................................... 3

2.0 SYSTEM COMPONENTS................................................................................................................................. 3
2.1 OPERATOR CONSOLE ................................................................................................................................... 4
2.2 SYSTEM CASE................................................................................................................................................. 9
2.3 PERIPHERAL CONNECTIVITY PANEL ........................................................................................................... 9
2.4 POWER PANEL................................................................................................................................................ 9

CHAPTER 3 - GETTING STARTED .......................................................................................................... 11

3.0 TURNING ON SYSTEM.................................................................................................................................. 11
3.1 CONNECTING TRANSDUCERS.................................................................................................................... 11
3.2 QSONIX FEATURE ........................................................................................................................................ 12
3.2.1 Quick Exam Start-up............................................................................................................................ 12
3.2.2 Operator Console Tutorial ................................................................................................................... 15
3.2.3 On-Line Live Chat Support .................................................................................................................. 16
3.3 ENTERING PATIENT DATA........................................................................................................................... 17
3.4 ENDING AN EXAM ......................................................................................................................................... 19
3.5 SELECTING TRANSDUCER, APPLICATION AND IMAGING PRESET ........................................................ 19
3.5.1 Selecting a Transducer, Application or Preset..................................................................................... 19
3.5.2 User-Defined Presets (Non-3D/4D Formats) ....................................................................................... 20

CHAPTER 4 - PATIENT MANAGEMENT ................................................................................................. 21

4.0 ENTERING PATIENT DATA........................................................................................................................... 21
4.0.1 Patient Information............................................................................................................................... 23
4.0.2 Application Information ........................................................................................................................ 24
4.0.3 Exam Information................................................................................................................................. 26
4.0.4 Storage Tabs ....................................................................................................................................... 27
4.1 LOCAL DIRECTORY - ENTERING/SELECTING A PATIENT ........................................................................ 29
4.1.1 Entering a New Patient ........................................................................................................................ 29
4.1.2 Selecting a Patient from Local Directory.............................................................................................. 29
4.1.3 Searching the Local Patient Directory.................................................................................................. 30
4.2 DICOM WORKLIST – SELECTING A PATIENT............................................................................................. 31
4.2.1 Selecting a Worklist Patient ................................................................................................................. 31
4.2.2 Performing a Worklist Search .............................................................................................................. 32

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CHAPTER 5 - IMAGING ............................................................................................................................ 33
5.0 2D/M-MODE....................................................................................................................................................33
5.0.1 2D (B-Mode) ........................................................................................................................................33
5.0.2 Clarity (Speckle Reduction)..................................................................................................................37
5.0.3 Spatial Compound Imaging..................................................................................................................37
5.0.4 2D Zoom Imaging ................................................................................................................................37
5.0.5 Dual Imaging Format ...........................................................................................................................38
5.0.6 Quad Imaging Format ..........................................................................................................................39
5.0.7 M-Mode Imaging Mode ........................................................................................................................40
5.0.8 Cine Clip Storage and Thumbnail Image/Clip Review .........................................................................41
5.1 COLOR/POWER DOPPLER ...........................................................................................................................44
5.1.1 Color Doppler Imaging Mode ...............................................................................................................46
5.1.2 Color Power Doppler Imaging Mode ....................................................................................................46
5.1.3 Simultaneous 2D/Color and 2D............................................................................................................46
5.2 PULSED WAVE (PW) DOPPLER ...................................................................................................................47
5.2.1 Pulsed Wave (PW) Doppler Imaging Mode..........................................................................................49
5.2.2 Triplex Imaging Mode ..........................................................................................................................49
5.3 PANORAMIC IMAGING ..................................................................................................................................50

CHAPTER 6 - 3D/4D IMAGING ................................................................................................................. 53

6.0 3D/4D IMAGING..............................................................................................................................................53
6.0.1 Freehand 3D Imaging (All Non-4D SONIX Transducers).....................................................................58
6.0.2 3D Imaging (SONIX 4D Transducer) ...................................................................................................60
6.0.3 4D Imaging (SONIX 4D Transducer) ...................................................................................................61
6.0.4 4D-Specific LCD Display Details..........................................................................................................61
6.0.5 3D/4D Image Formats for the LCD Display..........................................................................................62
6.0.6 Optimizing a 3D Image ........................................................................................................................63
6.0.7 Optimizing a 4D Image ........................................................................................................................65
6.0.8 3D/4D Active Rotation..........................................................................................................................69
6.0.9 4D and Cine .........................................................................................................................................70
6.0.10 User-Defined Presets for 3D/4D ..........................................................................................................70

CHAPTER 7 - CLINICAL ANALYSIS ........................................................................................................ 73

7.0 2D BASIC MEASUREMENTS.........................................................................................................................74
7.0.1 2D Linear Measurement ......................................................................................................................74
7.0.2 Area or Circumference (Area/Circ) Measurement................................................................................75
7.0.3 Volume Calculation ..............................................................................................................................76
7.0.4 Percent Diameter Reduction Calculation (% Diam Red) ......................................................................77
7.0.5 Percent Area Reduction Calculation (% Area Red)..............................................................................78
7.1 M-MODE BASIC MEASUREMENTS ..............................................................................................................82
7.1.1 M-Mode Heart Rate Measurement.......................................................................................................82
7.1.2 M-Mode Slope Measurement (Time, Slope and Distance) ..................................................................82
7.2 PW DOPPLER BASIC MEASUREMENTS......................................................................................................83
7.2.1 Velocity Measurement(s) .....................................................................................................................83
7.2.2 Doppler Manual Trace Measurement...................................................................................................84
7.2.3 Doppler Auto Trace Measurement (D-Range) .....................................................................................85
7.2.4 Doppler Heart Rate Measurement .......................................................................................................86
7.3 APPLICATION-SPECIFIC MEASUREMENT/CALCULATION ........................................................................87
7.4 REPORTS/CLINICAL ANALYSIS ...................................................................................................................89
7.4.1 Reports for all Applications ..................................................................................................................89
7.4.2 Obstetrics Report .................................................................................................................................89

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CHAPTER 8 - TEXT, ANNOTATIONS and PICTOGRAMS ..................................................................... 93
8.0 TEXT AND ANNOTATIONS ........................................................................................................................... 93
8.0.1 Keyboard Text ..................................................................................................................................... 93
8.0.2 Set Text Home Position ....................................................................................................................... 93
8.0.3 Application-Specific Annotations.......................................................................................................... 94
8.0.4 Deleting Text/Annotation ..................................................................................................................... 94
8.0.5 Text Arrow ........................................................................................................................................... 94
8.1 PICTOGRAMS ................................................................................................................................................ 95

CHAPTER 9 - SYSTEM SETUP ................................................................................................................ 97

9.0 USER SETTINGS ........................................................................................................................................... 99
9.0.1 Imaging Presets................................................................................................................................... 99
9.0.2 Imaging Presets – Annotations.......................................................................................................... 102
9.0.3 Imaging Presets – Pictograms ........................................................................................................... 104
9.0.4 Imaging Presets – 3D/4D................................................................................................................... 106
9.0.5 Annotations........................................................................................................................................ 107
9.0.6 Measurements ................................................................................................................................... 108
9.0.7 3D Settings ........................................................................................................................................ 116
9.0.8 Display Settings ................................................................................................................................. 118
9.1 ADMIN SETTINGS........................................................................................................................................ 119
9.1.1 System Settings................................................................................................................................. 119
9.1.2 Software Updates .............................................................................................................................. 121
9.1.3 Licensing and System Options .......................................................................................................... 122
9.1.4 DICOM Configuration ........................................................................................................................ 124
9.1.5 Peripherals ........................................................................................................................................ 134
9.1.6 Patient Settings ................................................................................................................................. 139
9.1.7 Print Keys .......................................................................................................................................... 141
9.1.8 Capture Settings ................................................................................................................................ 143
9.1.9 Network Configuration (Internet or Dialup) ........................................................................................ 144
9.2 SERVICE MENU........................................................................................................................................... 146

CHAPTER 10 - CONNECTIVITY and PERIPHERALS ........................................................................... 147

10.0 SYSTEM CASE CONNECTIVITY PANEL .................................................................................................... 147
10.1 BACK CONNECTIVITY PANEL .................................................................................................................... 149
10.2 FRONT CONSOLE CONNECTIVITY............................................................................................................ 150
10.3 ULTRASONIX-APPROVED DEVICES ......................................................................................................... 150

CHAPTER 11 - IMAGE STORAGE and REVIEW................................................................................... 151

11.0 IMAGE STORAGE ........................................................................................................................................ 151
11.1 IMAGE REVIEW ........................................................................................................................................... 151
11.1.1 Deleting Image/Study ........................................................................................................................ 155
11.2 IMAGE TRANSFER ...................................................................................................................................... 156

CHAPTER 12 - SYSTEM SPECIFICATIONS.......................................................................................... 159

12.0 TRANSDUCER SPECIFICATIONS .............................................................................................................. 162
12.1 MEASUREMENT ACCURACY ..................................................................................................................... 162
12.1.1 Geometric Measurement Accuracy.................................................................................................... 162
12.1.2 Non-Geometric Measurement Accuracy............................................................................................ 164
12.2 ACOUSTIC OUTPUT TABLES ..................................................................................................................... 165
12.3 ULTRASOUND INDICATIONS FOR USE TABLES...................................................................................... 197

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CHAPTER 13 - SAFETY, MAINTENANCE and CLEANING.................................................................. 207
13.0 SAFETY ........................................................................................................................................................207
13.0.1 ALARA Principle and Output Displays ...............................................................................................207
13.0.2 Basic Precautions ..............................................................................................................................208
13.0.3 Symbol Definitions .............................................................................................................................209
13.0.4 Electrical Safety Requirements ..........................................................................................................210
13.0.5 EMC (Electro-Magnetic Compatibility) Requirements ........................................................................210
13.0.6 Environment Conditions .....................................................................................................................210
13.0.7 Limiting Transducer Surface Heating.................................................................................................211
13.0.8 Latex ..................................................................................................................................................211
13.1 TRANSDUCER AND SYSTEM MAINTENANCE ..........................................................................................212
13.1.1 Guidelines ..........................................................................................................................................212
13.1.2 Ultrasound Coupling Gels ..................................................................................................................212
13.1.3 Cleaning/Sterilizing Recommendations and Warnings for all Non-Invasive Transducers ..................213
13.1.4 Cleaning/Sterilizing Recommendations and Warnings for all Invasive Transducers..........................216
13.1.5 System Cleaning Recommendations .................................................................................................219

CHAPTER 14 - REFERENCES ............................................................................................................... 221

14.0 OB REFERENCES........................................................................................................................................221
14.1 GENERAL AND CARDIAC REFERENCES ..................................................................................................225

CHAPTER 15 - GLOSSARY.................................................................................................................... 227

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CHAPTER 1 - INTRODUCTION

This user manual provides SONIX system operator details and specifications. This is not a service
manual. A separate manual with SONIX service details is available.

1.0 AUDIENCE

This user manual is a reference for operators using the SONIX ultrasound system. It is designed
for a reader familiar with ultrasound imaging techniques; it does not provide training in sonography
or clinical practices. Before using the system the operator must have ultrasound training.

1.1 CONVENTIONS

The following conventions are used in this manual:

• Words that are bold and italic refer to items on the monitor screen (onscreen).
• Words that are BOLD and CAPITALISED refer to buttons, dials and toggle buttons located on
the Operator Console.
• “Press” and “Turn” indicate the actions required to activate the operator console buttons, toggle
buttons and dials.
• “Tap” indicates the action required to activate a touch screen item.
• “Select” indicates the action required to choose items from onscreen (on monitor) forms, menus
and dialog boxes. The console trackball is used to position the onscreen arrow and flashing
cursor.
• The SELECT button on the Operator Console acts much as the “left-click” on a mouse. It will
set the cursor location for text entry or select an onscreen item. Use the trackball to position the
cursor.)
• To “right-click”, as with a mouse, press the UPDATE button on the Operator Console.
• A “Warning” describes precautions necessary to prevent injury or loss of life.
• A “Caution” describes precautions necessary to protect the products.
• A “Note” describes helpful information.
• A high-lighted “Note” describes a helpful hidden functionality.
• When the steps in the operating instructions must be performed in a specific order, the steps
are numbered.
• Bulleted lists present information in list format, but they do not imply a sequence.

1.2 UPDATES

Updated user manuals will accompany all future SONIX ultrasound system updates.

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1.3 LICENSE AGREEMENTS

All SONIX computer programs have been patented by Ultrasonix Medical Corporation (Ultrasonix).
Such programs are licensed under the following software license agreement:

Ultrasonix, or its suppliers, retain(s) ownership of and title to any computer program supplied
with the Equipment and to the trade secrets embodied in such computer programs. Subject to
the Buyer’s acceptance and fulfillment of the obligations in this paragraph, Ultrasonix grants
the Buyer a personal, non-transferable, perpetual, non-exclusive license to use any computer
program supplied with the Equipment that is necessary to operate the Equipment solely on
the medium in which such program is delivered for the purpose of operating the Equipment in
accordance with the instructions set forth in the operator’s manuals supplied with the
Equipment and for no other purpose whatsoever. Buyer may not reverse – assemble, reverse
– compile or otherwise reverse – engineer such computer programs nor may Buyer make a
copy of such program or apply any techniques to derive the trade secrets embodied therein.
In the event of a failure by Buyer to comply with the terms of this license, the license granted
by this paragraph shall terminate. Further, because unauthorized use of such computer
programs will leave Ultrasonix without an adequate remedy at law, Buyer agrees that
injunctive or other equitable relief will be appropriate to restrain such use, threatened or
actual. Buyer further agrees that (i) any of the Ultrasonix suppliers of software is a direct and
intended beneficiary of this end-user sublicense and may enforce it directly against Buyer
with respect to software supplied by such supplier, and (ii) NO SUPPLIER OF ULTRASONIX
SHALL BE LIABLE TO BUYER FOR ANY GENERAL, SPECIAL, DIRECT, INDIRECT,
CONSEQUENTIAL INCIDENTIAL OR OTHER DAMAGES ARISING OUT OF THE
SUBLICENSE OF THE COMPUTER PROGRAMS SUPPLIED WITH THE EQUIPMENT.

1.4 TRADEMARKS AND PATENTS

Ultrasonix SONIX systems are protected under US patents 6,911,008 - 6,558,326 - 6,325,759.

Windows® is a trademark of Microsoft Corporation.

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CHAPTER 2 - SONIX INTRODUCTION

Congratulations on your purchase of the Ultrasonix SONIX Ultrasound system. The SONIX is a high
quality, easy to use diagnostic ultrasound system. The Ultrasonix SONIX system is stable, highly mobile
and is designed to be convenient and comfortable to operator.

The system components (LCD display, LCD display lift system, operator console with keyboard, base,
cart and ultrasound transducers) may be configured to better support system use. The console soft touch
controls are arranged in a manner that allows easy access.

2.0 SYSTEM COMPONENTS

LCD Display

LCD Display
Lift System
Touch Screen

Console Release
Operator Console Handle
with Keyboard

CD/DVD and Front Pull Handle

USB Ports

Peripherals Bay
System Case with
Three Transducer Ports

Wheel Base with

Four Locking Wheels
Foot Rest

Note: The rear wheels on the SONIX SP are directionally locking, while the front wheels lock in a single
position. All SONIX OP wheels lock in a single position.

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2.1 OPERATOR CONSOLE

The Operator Console is comprised of a panel with patient management, system setup and
ultrasound imaging controls: trackball, buttons, dials, toggle buttons, touch screen and keyboard.
These operator controls provide the SONIX functions such as selecting transducers, changing
imaging modes, adjusting parameters like TGC, depth and others.

Buttons light up when the feature/functionality is available for use. For instance the buttons used for
adjusting the Color imaging parameter will not light up on the console until the COLOR imaging
mode is selected thus indicating they are available for use.

Thumb Grips
for Rotating
Console

Note: Not all features listed are available on all systems configurations.

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 Location System Control Functionality
Turns system ON/OFF. Refer to section 9.1.1 System Settings to
1 Power Button
configure for Fast Boot-up mode.
2 ID Button Provides access to Patient Management System.
3 PROBE Button Provides access to Transducer selection keys on touch screen.
4 MENU Button Provides access to System Setup menus.
Turns on/off application specific Pictogram graphics. Tap through
PICTOGRAM the various icons. A long pause between taps deletes the
5
Button pictogram. Trackball positions/rotates the orientation marker.
UPDATE toggles trackball between position and rotate control.

Turns on/off Arrow graphic on the image field. Trackball positions

6 ARROW Button
and rotates the arrow graphic.
QWERTY keyboard used for text entry (i.e., patient data, system
7 Keyboard
setup, image text, etc.).
Provides:
• Quick exam start-up
8 QSONIX Button
• SONIX Operator Console Tutorial
• On-line support access
Activates the keyboard for Text entry and initiates the application
9 TEXT Button
specific touch screen annotations.
Deletes the most recent Text or Annotation entry. Provides “delete
10 DEL Button
character” function during data entry mode (ID page).
Used to position the onscreen arrow graphic, flashing text cursor,
11 Trackball
arrow cursor, calipers, etc.
In Measure mode, deletes most recently saved measurement.
12 DEL Button
Deletes selected thumbnail image.
Initiates/closes the Measurement/Calculation package. Removes
13 MEASURE Button measurements from frozen image field. Application specific
measurement tabs available on touch screen.

Provides a wide variety of functions dependent on the imaging

14 SELECT Button state (i.e., select and set measurements, set annotation home
location, select on-screen keys, etc.).
Provides a wide variety of functions dependent on the imaging
state (i.e., toggle between image fields on dual/quad image, toggle
15 UPDATE Button
between 2D and Doppler trace image fields, toggles the active
caliper, etc) and provides a “Right Click” functionality.
16 FREEZE Button Pause/resume a live image.

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 Location System Control Functionality
One of 3 programmable buttons used to auto store/print images or
17 PRINT 1 Button
cine loops to a configured printers, archiver, etc.
Print Controls

One of 3 programmable buttons used to auto store/print images or

18 PRINT 2 Button
cine loops to a configured printers, archiver, etc.
One of 3 programmable buttons used to auto store/print images or
PRINT 3/
19 cine loops to a configured printers, archiver, etc. or set to provide
ARCHIVE Button
access to the Patient Management Image Review System.

B-MODE/2D Activates (press dial) 2D/B-Mode imaging mode and controls 2D

20
Button/Dial gain (turn dial) and M-mode gain.
Activates Dual (press once) and Quad (press twice) split screen
DUAL/QUAD
21 imaging. UPDATE button toggles between image fields. Press B-
Button
B-Mode/2D and M-Mode Controls

MODE to return to single screen imaging.

Activates M-mode imaging. B-Mode dial controls M-mode gain.
22 M-MODE Button
UPDATE button activates M-mode sweep.

FOCUS Adjusts the location of the image focal zone UP or DOWN on the
23
Toggle Button image field.

DEPTH Adjusts the 2D imaging depth UP (less depth) or DOWN (more

24
Toggle Button depth).

ZOOM Adjusts the 2D magnification UP (more magnification) or DOWN

25
Toggle Button (less magnification). Trackball used to Pan image.
Adjusts the 2D image Frequency UP or DOWN :
• Harmonics (if available)
FREQ
26 • Resolution (high frequency)
Toggle Button
• General
• Penetration (low frequency)

COLOR Doppler Activates (press dial) Color Doppler imaging mode and controls
27
Button/Dial Color Doppler gain (turn dial). Controls Power Doppler gain.
Color Doppler Controls

28 INVERT Button Reverses the direction of the Color Doppler map.

PRF Adjusts the Color Doppler PRF (Pulse Repetition Frequency) UP

29
Toggle Button (higher PRF) or DOWN (lower PRF).
Adjusts the Color Doppler Wall Filter UP (more filtering) or DOWN
30 WF Toggle Button
(less filtering).

POWER Activates/Deactivates the Color Power Doppler imaging mode. The

31
DOPPLER Button Color Doppler dial controls the Color Power gain.

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 Location System Control Functionality
Adjusts the steering angle dependent on the active imaging mode:
STEER • Color Doppler Region of Interest (ROI) box
32
Toggle Button • PW Doppler sample line
• B-Mode/2D beam on linear transducers

Activates/Deactivates (press dial) Pulsed Wave (PW)

Doppler imaging mode and controls PW Doppler gain (turn dial).
PULSED Controls CW Doppler gain.
33 DOPPLER
UPDATE button switches between trace and 2D image.
Button/Dial
Note: To adjust the PW gate size on full screen 2D/Doppler
cursor, turn the Pulsed Doppler dial.
PW Doppler Controls

34 CW Button Not available in this release.

BASE
35 Adjusts the PW Doppler Trace baseline UP or DOWN.
Toggle Button

PRF Adjusts the PW Doppler PRF (Pulse Repetition Frequency) UP

36
Toggle Button (higher PRF) or DOWN (lower PRF).
37 INVERT Button Reverses the direction of the PW Doppler trace.

Activates (press dial) the PW angle correct feature. Each

ANGLE
subsequent press toggles through 0, +60, -60 degrees. Turn the
38 CORRECT
dial right or left to adjust the angle correct in 2 degree increments
Button/Dial
up or down.

RESEARCH
39 Activates/Deactivates the optional Research Imaging Package.
Button
40 & 41 Inactive Buttons Currently in-active buttons – future.

SPATIAL
42 COMPOUND Activates/Deactivates the Spatial Compounding imaging mode.
Button
43 3D/4D Button Activates/Deactivates the optional 3D and 4D imaging modes.
Activates/Deactivates the auto optimize feature for the Doppler
44 OPTIMIZE Button
trace.
Adjusts (turn dial) the Acoustic Power and toggles (press dial) MI,
ACOUSTIC TIS, TIC, TIB display dependent on the active imaging mode.
45 POWER
Button/Dial Warning: Refer to section 13.0.1 ALARA Principle and
Output Displays.

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 Location System Control Functionality
46 TGC Slide Pods Adjusts the TGC (Time Gain Compensation) curve.

Four (4) dials that control remappable touch screen keys which
change depending on the imaging mode/state.
Note: In measure mode if a “‹‹|››” appears on the touch screen
key the measurement can be performed using different
47 – 50 Touch Screen Dials methods. Tap to select the measurement. Turn the touch
screen dial directly below the desired measurement to page
through the various method choices available. The method
selected appears in an information bubble to the bottom
right of the image screen. Refer to Chapter 7 - Clinical
Analysis for further details.

Displays remappable touch screen menus which change

depending on the imaging mode/state.
51 Touch Screen
Note: The active tab on a touch screen menu will be indicated by a
“dot” pattern below the tab name.

AUDIO VOLUME
52 Adjusts the audio volume of the Doppler signal.
Dial
53 Microphone Vent Future - voice command feature

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2.2 SYSTEM CASE

The system case contains the system PC and internal connectivity panel. Three transducer ports
are available at the front of the system case.

Caution: Access to the internal connectivity panel (through the top of the system case) should be
restricted to qualified service personnel only. Contact your local service representative
for further information.

Refer to the Service Manual for complete details about the system case.

Warning: Do not touch the signal input and signal out ports, located within the system case
and the patient simultaneously.

2.3 PERIPHERAL CONNECTIVITY PANEL

The peripheral connectivity panel is located on the peripheral tower which extends up from the
back of the system case. Refer to section 10.1 Back Connectivity Panel for peripheral
connectivity details.

2.4 POWER PANEL

The power panel is located on the back lower portion of the system case. The power panel
includes the power cord plug, main power switch, voltage switch and fuse.
Note: If the system does not power up, ensure the power cord is plugged in and the main power
switch on the back of the system case is turned to the ON position. The Main Power switch
is not required for regular power shut downs and should remain in the ON position.

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CHAPTER 3 - GETTING STARTED

This chapter provides a basic step-by-step guide through the basic operation of the SONIX Ultrasound
System.

3.0 TURNING ON SYSTEM

To turn on the system:

1. Connect the AC power cord to the back of the system case and connect to a power
outlet - hospital-grade electrical outlet recommended.
2. Press the Power button located on the left side of the Operator Console to turn the
system ON or OFF. Refer to section 2.1 Operator Console for power button location.
Note: If the system does not power up, ensure the Main Power switch on the back of the
system case is turned to the ON position (”--“). Refer to section 2.4 Power Panel for
main power switch location. The Main Power switch is not required for regular power
shut downs and should remain in the ON position.

3.1 CONNECTING TRANSDUCERS

The connection ports for the SONIX transducers are located on the front of the SONIX system
case. Refer to section 2.0 System Components for location of transducer ports.

To connect a transducer:
1. Turn the latch to the open position – rotate counter-clockwise to the open (un-lock)
position as seen in graphic image below.
2. Insert the connector of the transducer into the connection port with the cable directed to
the right of the system.

Caution: The 4D transducer MUST be inserted into the upper most transducer
connection port to ensure proper function.

3. Ensure the transducer is snugly in place and turn the latch mechanism clockwise to
lock in place.
4. Turn the latch mechanism counter-clockwise to un-lock (open) and remove the
transducer.
Note: When a new exam is initiated, the transducer used in the most recent exam will
still be selected if it is still connected. If it’s no longer connected, the system will
default to the first available transducer. This default transducer selection is not
affected even if the system is turned off between exams.

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3.2 QSONIX FEATURE

The QSONIX button provides three basic functions:

• Quick Exam Start-up (1)
• Operator Console Tutorial (2)
• On-line Support Access (3)

Note: If desired, after initial access to the QSONIX feature, use the trackball and SELECT
button to check Skip Welcome Page to remove this page from future viewing.

3.2.1 Quick Exam Start-up

The Quick Exam Start-up feature provides a series of menus which guide the user through
the steps required for configuring the system in order to begin a study:
• Select the clinical application
• Select the transducer
• Select the imaging preset
• Enter the basic patient data.

To begin the Quick Exam Start-up:

1. Press the QSONIX button located at the center of the Operator Console.
2. If the Welcome to QSONIX page appears on the LCD display, select Next.
Note: If the Welcome to QSONIX page has been set to “skip”, it can be reset to
appear by selecting the Welcome Page button. Select Skip to prevent the
Welcome Page from appearing the next time QSONIX button is selected.

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 3. Use the trackball and console SELECT button to highlight the desired application from
the Select Exam Type/Application page, then select Next.

4. Use the trackball and console SELECT button to highlight the desired transducer from
the Select Transducer page, then select Next.

Note: Only transducers currently connected to the system and applicable to the
previously-selected clinical application will be available. If the selected clinical
application is not available for use with the currently connected transducers, the
system will prompt for a different transducer, or select Back to return to the
previous step to select a different clinical application.

5. Use the trackball and console SELECT button to highlight the desired Preset from the
Select Imaging Preset page, then select Next.

Note: If an Imaging Preset has been hidden, it will not be available for selection. Refer
to 9.0.1 Imaging Presets, for details on Show/Hide Imaging Presets.

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 6. Use the keyboard to enter data in the Input Patient Information page. Press Tab on the
keyboard to move through the data fields.

The Insert Symbol tool

enables the insertion of
text symbols not available
on the keyboard
(e.g., apostrophe).

More… links to
the full Patient
Information page.

Note: If additional patient information is required select More… to open the full Patient
Management data entry pages. Refer to Chapter 4 - Patient Management for
complete details on Patient Management data entry.

7. Tab down to Start Exam and press the console SELECT button to start imaging.

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 3.2.2 Operator Console Tutorial

This feature provides the user with a quick overview of the functionality of the operator
console buttons, toggle button, dials, etc.

To access the Operator Console Tutorial:

1. Press the QSONIX button in the center of the operator console.
2. The Welcome to QSONIX page appears on the LCD Display.

Note: If the Welcome to QSONIX page does not appear, select the Welcome Page
button.

3. Select SONIX Console Tutorial. As per the onscreen instruction, after selecting each
of the various console and touch screen buttons, dials, etc., the Tutorial will provide a
brief, onscreen description of the function of the selected item.

4. Select Exit Tutorial to return to the Welcome to QSONIX page.

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 3.2.3 On-Line Live Chat Support

The On-line support feature is a real-time help discussion with the Ultrasonix Technical
Support team. Refer to section 9.1.9 Network Configuration (Internet or Dialup) to
configure the system for live chat support and network connectivity.

To access the on-line live chat support:

1. Press the QSONIX button in the center of the operator console.
2. To access the online chat window, select Online Support… from the bottom left side
of the Welcome to QSONIX page.

3. Use the keyboard to type in the desired message in the text box. Press the Send
button to send the message.

4. To close the online chat window, select the “X” in the red box in the upper right corner
of the window.

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3.3 ENTERING PATIENT DATA

The patient management (ID) page enables users to enter patient and exam related data into the
system created patient file. The system creates a patient file to store patient and exam data which
are used to automatically populate the patient report pages. This section describes the steps
required to enter patient data for non-DICOM users. Refer to section 4.2 DICOM Worklist for
details on DICOM Worklist patient data entry.

To begin a new study:

1. Press the ID button located on the upper left side of the operator console to access the
patient management data entry page.
2. The patient management ID page appears on the monitor.

The Insert Symbol tool enables the

insertion of text symbols not available
on the keyboard (e.g., apostrophe).

3. The text cursor defaults to the Patient ID data field unless a current exam is open. To
end the current exam session, select the End Exam button near the top right corner of
the screen.
4. Use the keyboard and trackball to enter the patient and study data as required.
Note: The Tab key may be used to move through the page. The Enter key is used to
make drop down menu selections.

5. If the Patient ID or Name has previously been saved to the system, the patient may be
selected from the list of patient files located under the Local tab at the bottom of the
Patient management page. Use the trackball to position the arrow cursor over the
desired patient. Press SELECT on the console to auto-populate the patient data fields.
Study data may be edited as required.
6. Select OK from the top of the ID page or tap OK on the touch screen to save the
changes and move to live imaging. The patient ID, name, LMP (if applicable) and
operator ID details appear at the top of the image field.

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 Notes:
• OK saves the changes made to the Patient Management ID page and returns to live
2D imaging.
• End Exam ends the current exam session, clears the Patient, Application and Exam
data fields and clears the printer queue (i.e., If printer image sheet is set for 2 x 2 and
only 2 images were saved, ending the exam signals the system that no more images
are coming to fill up the sheet and sends the image sheet to the printer.). All previous
exam measurements saved to report are cleared.
• Clear clears the Patient and Study data fields. Clear will also “End” the current exam if
one is open.
• Cancel cancels any changes made to the ID page and returns to live imaging. Cancel
will not undo the End Exam function.
• OK, End Exam, Cancel, Clear, Update Worklist and Toggle Tabs (toggle between
Local, Hide and Worklist tabs) are accessible from the touch screen.
Note: Worklist options are only available if Worklist has been enabled in DICOM.

• The patient ID cannot be changed after the exam has begun.

• Select the appropriate clinical application (Cardiac, Gynecology, Obstetrics or Other) in
the Application Information section to enter application specific data (i.e., LMP,
previous OB measurements for trending, height, weight, etc.) The application selected
here is not tied to the imaging presets or exam type.
• If Patient Name, ID, LMP, etc. are not displayed at the top of the image screen, the
system may be setup to hide the patient data. Refer to section 9.1.6 Patient Settings
to Show/Hide Patient Data.
• To show/hide Patient and Study data fields, refer to section 9.1.6 Patient Settings.
• Review opens the Image Management page for the current patient or selected
patient(s) from the Local file storage.
• Delete removes the currently selected patient(s) from the Local file storage.
• Use the “Insert” Symbol tool to enter a symbol not available on the keyboard (i.e.,
apostrophe).

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3.4 ENDING AN EXAM

To end the current exam session:

1. Press the ID button and tap END EXAM on the touch screen or select End Exam from
the ID page.
Note: End Exam ends the current exam session, clears the Patient and Study data
fields and clears the printer queue (i.e., if printer image sheet is set for 2 x 2 and
only 2 images were saved, End Exam signals the system that no more images
are coming to fill up the sheet). All previous exam measurements saved to the
current Report are cleared.

3.5 SELECTING TRANSDUCER, APPLICATION AND IMAGING PRESET

Imaging presets specific to each clinical application are available with each of the SONIX system
transducers. The clinical applications and presets vary depending on the transducer type.
Additional user-defined, custom imaging presets may be created and stored with the factory
installed Presets.

3.5.1 Selecting a Transducer, Application or Preset

To select or change a transducer, application or imaging preset:

1. Press the PROBE button on the left side of the operator console.
2. Up to three (3) options are presented on the touch screen listing the transducers
connected to the system. Select the transducer required for the exam by tapping the
appropriate key.
3. A Presets tab appears on the touch screen with two sections. The upper section lists
the clinical applications available for the selected transducer and the lower section lists
the associated imaging presets. Tap the desired clinical application.
4. The system will update the lower portion of the Presets tab with the available Imaging
Presets for the selected clinical application. Tap the desired Imaging Preset. The
system will move to live imaging.
Note: If an Imaging Preset has been hidden, it will not be available for selection from
the touch screen. This option applies to both default and user-defined Presets.
Refer to 9.0.1 Imaging Presets, for details on Show/Hide Imaging Presets.

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 3.5.2 User-Defined Presets (Non-3D/4D Formats)

User-defined Presets may be created and saved to the system clinical application. They
are presented for selection along with factory defaults when selecting Transducer,
Application and Preset. Refer to section 9.0.1 Imaging Presets for details on user-defined
Presets.
In addition to standard Presets, the SONIX also allows users to create and save user-
defined 3D/4D presets. Because a 3D/4D image must be acquired before a 3D/4D user-
defined Preset can be created, please refer to 6.0.10 User-Defined Presets for 3D/4D for
details.
During imaging, a user-defined Preset name is shown on the LCD display in square
brackets (e.g., [User-Defined Preset]). On the touch screen, user-defined presets are
presented in italics (e.g., User-Defined Preset).

To save user-defined Presets:

1. Select a Preset similar to the required user-defined Preset.
2. Adjust the imaging parameters (e.g., depth, dynamic range, gain, sector size, default
color direction, etc…).
3. Tap the Presets tab on the touch screen.
4. Tap the Save Preset button on the bottom of the touch screen. The Save Preset
dialog box will be presented.

5. From the Select Application drop down menu, chose the appropriate Application
under which the new Preset will be stored: Obstetrics, Pelvic, Abdomen, Vascular,
Small Parts, Generic, Cardiac.
6. Use the keyboard to enter a Preset Name.
7. Select OK to save the Preset or Cancel to exit the menu without saving the changes.
8. The user-defined Preset will now be available on the Imaging Presets page under the
selected clinical application.
Note: For details on the Imaging Presets page, refer to 9.0.1 Imaging Presets.

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CHAPTER 4 - PATIENT MANAGEMENT

This chapter provides details about the Patient Data Entry, Worklist and Patient Review features available
on the SONIX Ultrasound System.

4.0 ENTERING PATIENT DATA

To access the patient and study data entry page, press the ID button on the operator console. The
following page appears on the monitor:
The ID page is sectioned into Patient Information, Application Information and Exam
Information data entry areas. The Patient List queues (Local storage and Worklist – if applicable)
are located on the lower portion of the page.
Note: Once an exam has been concluded, the patient’s file will deleted if no Patient Name was
entered, no images were stored and no measurements were taken.

The Insert Symbol tool enables the

insertion of text symbols not available
on the keyboard (e.g., apostrophe).

Local Storage tab

Worklist Tab (if enabled in DICOM)
Hide Tab (Blank for Patient Data Privacy)

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 Notes:
• A patient must be selected prior to saving images and performing 3D/4D imaging.
• Use the keyboard and trackball to enter the patient and study data as required. The Tab key
may be used to move through the page. The Enter key may be used to make drop down menu
selections.
• OK saves the changes made to the Patient Management page, begins a new exam and returns
to live 2D imaging. The system automatically creates a unique ID if one is not entered manually
(e.g., {C9B3F82B-BE52-4C79-8C45-28375D69F8C9}).
• End Exam ends the current exam session, clears the Patient, Application and Exam data fields
and clears the printer queue (i.e., If printer image sheet is set for 2 x 2 and only 2 images were
saved, ending the exam signals the system that no more images are coming to fill up the sheet
and sends the image sheet to the printer.). All previous exam measurements saved to report
are cleared.
• Clear clears the Patient and Study data fields. Clear will “End” current exam if one is open.
• Cancel cancels any changes made to the ID page and returns to live imaging. Cancel will not
undo the End Exam function.
• OK, End Exam, Cancel, Clear, Update Worklist and Toggle Tabs (toggle between Local,
Worklist and Hide tabs) are accessible from the touch screen.
• The Patient ID cannot be changed after the exam has begun.
• Select the appropriate clinical application (Cardiac, Gynecology, Obstetrics or Other) in the
Application Information section to enter application specific data (i.e., LMP, previous OB
measurements for trending, height, weight, etc.). The application selected here is not tied to the
imaging presets or exam type.
• If Patient Name, ID, LMP, etc. are not displayed at the top of the image screen, the system may
be setup to hide the patient data. Refer to section 9.1.6 Patient Settings to Show/Hide Patient
Data.
• To show/hide Patient and Study data fields, refer to section 9.1.6 Patient Settings.
• Search Worklist opens up a separate Worklist search page allowing for a Worklist specific
search (i.e., by date or modality).
• Insert Symbol enables users to insert a text symbol not available on the keyboard (e.g.,
apostrophe) into the data fields.
• Review opens the Image Management page for the current patient or selected patient(s) from
the Local file storage.
• Delete removes the currently selected patient(s) from the Local file storage.
• Update Worklist updates the Worklist patient list.

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 4.0.1 Patient Information

To enter Patient Information data:

1. Use the keyboard, trackball and console SELECT button to enter the patient
information as required.
• The Tab key may be used to move through the page.
• The Enter key may be used to move through drop down menu options.

Patient Information Data Fields:

Patient identifier – Enter letters and/or numbers

• the ID cannot be modified after the patient file has been created
Patient ID
• the system automatically creates a unique ID if one is not entered
manually (e.g., {C9B3F82B-BE52-4C79-8C45-28375D69F8C9}).

Last Name Patient’s last, first and middle names

First Name
• any of the names can be modified at any point during the exam.
Middle Name

DOB Patient’s date of birth – MM/DD/YYYY format

(Date Of Birth) • a DOB entry will auto-populate the Age field.

Patient’s age
Age • the age field will auto-populate if a DOB is entered
• a specific age can be entered instead of the DOB.

Patient’s sex
Sex
• select from Female, Male, Other or Unknown.

Study accession number

Accession #
• accession # auto populates when DICOM Worklist is used.

Insurance # Patient’s insurance number.

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 4.0.2 Application Information

To enter Application specific data:

1. Press the console ID button to open the Patient Management ID page.
2. Tab to the Application drop down menu on the right side of the Application Information
section.
3. Select the desired Application from the drop down menu.

4. The application related data entry fields to the left side of the Application Information
section change with the selection of the various applications. The Enter key may be
used to make drop down menu selections.
Note: Selecting an Application here does not select a specific imaging application or
preset.

Application Information Data Fields:

Cardiac

• Height and Weight – select between metric and imperial measurements.

• BSA (body surface area) – calculated and displayed when Height/Weight entered
• HR (Heart Rate) – bpm (beats per minute)

Gyn
• LMP (Last Menstrual Period)
• Exp. Ovul. (Expected Date of Ovulation)
• Day of Cycles
• Gravida, Para and Aborta fields

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 Application Information Data Fields:

• LMP (Last Menstrual Period) – auto calculates GA and EDD

• LMP is displayed at the top of the image field
• GA (Gestational Age) – auto calculates EDD
Note: Must enter both weeks (w) and days (d) to auto calculate EDD.
OB • EDD (Estimated Delivery Date) – auto calculates GA
Note: If the GA and EDD are entered manually, they will override the LMP field
entry.
• Gravida, Para and Aborta fields
• Fetus # – enter for multiple gestations (maximum of 3)
o Required to activate multiple (A, B, C) measurement packages
• BBT (Basal Body Temperature) – enter Celsius or Fahrenheit
Note: BBT is only available if it was selected in Patient Settings (9.1.6 – Patient
Settings)
• Previous Exam – enter previous OB exam data for fetal trending (details below)

Other

• Height and Weight - select between metric and imperial measurements.

• BSA (Body Surface Area) – calculated and displayed when Height/Weight entered

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 4.0.2.1 OB Previous Exams

To enter previous exam data for fetal trending:

1. Press the console ID button to open the Patient Management ID page.
2. Select Previous Exam from the OB Application Information data entry section.
3. The previous exam data entry page appears on the screen.

4. Use the keyboard and trackball to enter the previous exam date and corresponding
fetal measurement data (BPD, HC, etc.) for the fetus(es) as required.
Note: The Tab key may be used to move through the page.

5. Select OK to save the data and return to the Patient Management page or select
Cancel to exit the page without saving the data.
6. The data entered is plotted on the growth graphs as part of the OB report package.
Note: Trending data from previous exams stored on the system does not appear in this
list. Instead, it is displayed on the individual trending graph OB report pages with
an active patient.

4.0.3 Exam Information

To create a Custom Label, refer to 9.1.6 Patient Settings.

To enter exam information data:

1. Press the console ID button to open the Patient Management ID page.
2. Use the keyboard and trackball to enter the exam information as required.
3. Once entered, the text entered is available for recall from the drop down menu.
Note: The Tab key may be used to move through the page. The Enter key may be
used to move through the drop down menu selections.

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 Exam Information Data Fields:

Enter name of the Reporting Physician manually or select from drop down
Reporting Physician
menu of previously entered and currently active physician names.

Enter name of the Referring Physician manually or select from drop down
menu of previously entered and currently active physician names.
Referring Physician
The Referring Physician auto-populates when the patient is selected from
DICOM Worklist.
Enter name or initials of the operator or select from drop down menu of
Operator ID previously entered and currently active Operator IDs.
Operator ID appears at the top of image field.

Enter Exam Type manually or select from drop down menu of previously
entered and currently active exam types.
Exam Type
Exam Type is auto-populated when the patient is selected from DICOM
Worklist but can be modified.

Enter exam indication manually or select from drop down menu of

previously entered and currently active indications.
Clinical Indication
Clinical Indication is auto populated when the patient is selected from
DICOM Worklist but can be modified.

Custom Label 1
Enter user-defined data manually or select from drop down menu of
Custom Label 2
previously entered and currently active data.
Custom Label 3

Note: Refer to 9.1.6 Patient Settings, for details on editing/maintaining the data in these fields.

4.0.4 Storage Tabs

To the right of the Patient List is a series of up to three (3) vertical Storage tabs:

Storage Tabs
Local Select the Local tab to display a list of patients stored to the system’s local memory.

Select the Worklist tab to display the a patient list recently retrieved from DICOM
Worklist.
Worklist
Note: This tab is available only when the system is configured for DICOM Worklist.

Select the Hide tab to blank out the patient data. This feature provides patient data
Hide
privacy.

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 To change the layout of the patient data columns :
1. Press the console ID button to open the Patient Management ID page.
2. Use the trackball to position the arrow cursor over the Field Header to be moved.

Field Header

3. Simultaneously hold down the SELECT button and use the trackball to drag the column
to the desired location.

Note: To change the order of the list (e.g., from numerical by ID number to alphabetical
by Last Name), position the cursor over the relevant Field Header and press
SELECT. To reverse the order press SELECT again.

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4.1 LOCAL DIRECTORY - ENTERING/SELECTING A PATIENT

4.1.1 Entering a New Patient

To enter a new patient:

1. Press the console ID button to open the Patient Management data entry page.
Note: Ensure that no exam is currently open before attempting to enter a new patient
in this manner.

2. Use the trackball and SELECT button to position the text cursor in the Patient ID field
to begin data entry.
3. Use the keyboard and trackball to enter the patient and study data as required.
Note: The Tab key may be used to move through the page. The Enter key may be
used to move through the drop down menu selections.

4. Select OK to save the data and move to live imaging. The patient is added to the Local
directory at the bottom of the page.
Note: Once an exam has been concluded, the patient’s file will deleted if no Patient
Name was entered, no images were stored and no measurements were taken

Note: When a new exam is initiated, the transducer used in the most recent exam will
still be selected if it is still connected. If it’s no longer connected, the system will
default to the first available transducer. This default transducer selection is not
affected even if the system is turned off between exams.

4.1.2 Selecting a Patient from Local Directory

To manually select a previously stored patient from the local directory:

1. Press the console ID button to open the Patient Management ID page.
2. Select the Local tab at the bottom of the Patient Management page to display the
Local Patient Directory. A list of locally stored (system memory) patients is displayed.

Local Storage Tab

3. Use the trackball and SELECT button to select the desired patient. The patient data
fields are auto populated.
4. Modify patient and study data fields as required.

Note: The patient ID cannot be modified.

5. Select OK to save the data and move to live imaging.

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 Note: When a new exam is initiated, the transducer used in the most recent exam will
still be selected if it is still connected. If it’s no longer connected, the system will
default to the first available transducer. This default transducer selection is not
affected even if the system is turned off between exams.

4.1.3 Searching the Local Patient Directory

To search the local directory for a previously stored patient:

1. Press the console ID button to open the Patient Management page.
2. Select the Local tab at the bottom of the page to display the Local Patient Directory. A
list of locally stored (system memory) patients is displayed.
3. Use the keyboard and trackball to enter the patient search data (ID or Name, etc.). The
local patient directory narrows the list of patients that meet the entered search data.
4. Do one of the following:
• when the search criteria has narrowed the list to one selection, select it with the
trackball and press the ENTER button to populate the data fields with the
information
• when the search criteria has narrowed the list sufficiently (e.g., all patients with the
desired last name are visible), use the trackball and console SELECT button to
choose the correct Patient and then press ENTER.

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4.2 DICOM WORKLIST – SELECTING A PATIENT

Note: The system must be configured for DICOM Worklist for the Worklist feature to function. For
Worklist setup instructions, refer to section 9.1.4 DICOM Configuration.

4.2.1 Selecting a Worklist Patient

Advanced Worklist Search Button

Worklist Update Button

Worklist Tab

To select a patient from the Worklist:

1. Press the console ID button to open the Patient Management page.
2. Select the Worklist tab at the bottom of the page to display the DICOM Worklist
Patient list.
3. If the desired patient is not available from list, select Update Worklist to the right of the
list to update the Worklist.
Note: Updates will be base upon the last search performed.

4. Use the trackball and SELECT button to select the desired patient. The patient data
fields are auto populated.
5. Modify patient and study data fields as required. The patient ID can not be modified.
Note: Modifications to auto-populated Worklist fields (Name and Accession #) are
not recommended.

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 6. Select OK to save the data and move to live imaging. A patient file is created in the
Local Directory. The patient file is automatically deleted at the end of the exam if no
images are stored to the system for this patient.
Note: When a new exam is initiated, the transducer used in the most recent exam will
still be selected if it is still connected. If it no longer connected, the system will
default to the first available transducer. This default transducer selection is not
affected even if the system is turned off between exams.

4.2.2 Performing a Worklist Search

To perform a Worklist search:

1. Select Search Worklist from the Patient Management page.
2. The Worklist Search Criteria page appears on the screen.

3. Use the keyboard and trackball to enter the patient search data (ID or Name, etc.).
Note: Worklist text fields can be searched with wildcards, e.g., entering SMI* in the
Last Name field will find all names beginning with SMI.

4. Select Search to update the Worklist with the advanced search criteria.
Note: The parameters from the last search will be retained for the duration of the
current (computer-defined) date.

Note: Worklist Search results are limited to a maximum of 100 records. Any result list
longer than 100 records will be truncated.

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CHAPTER 5 - IMAGING

The SONIX buttons controlling key imaging methods are organized into specific sections on the operator
console (i.e., 2D, Color, Doppler, Print, etc.). Refer to section 2.1 Operator Console for layout details.
Additional imaging controls are accessible on the touch screen when a specific imaging mode is active.
Touch screen imaging controls are organized by tabs for each active imaging mode.
Note: Not all imaging modes or features are available with all system configurations.

5.0 2D/M-MODE

5.0.1 2D (B-Mode)

2D or B-mode is the default imaging mode on the SONIX system. The key 2D imaging
controls are located to the upper right portion of the operator console with the exception of
the 2D STEER button which is located between the Color and Doppler controls:

2D Imaging Console Controls:

Turn to adjust overall gain
B-MODE button/dial
Press to exit other imaging modes and return to 2D imaging
FREQ toggle button Press up or down to adjust the transducer frequency
Press up or down to zoom the image in or out. Press B-Mode to
ZOOM toggle button
exit Zoom.
DEPTH toggle button Press up or down to adjust the imaging depth up or down
FOCUS toggle button Press up or down to adjust focal zone position up or down

DUAL/QUAD button Press once to activate Dual and twice to activate Quad imaging
M-MODE button Press to activate M-mode imaging mode

Press to steer the 2D beam on linear transducers. This function is

STEER toggle button
not available when Color or Doppler imaging modes are active.

The TGC slide pods located to the right of the touch screen are used to adjust the time gain
compensation (TGC).
Note: Press the B-MODE button/dial to exit other imaging modes (Color, PW Doppler, M-
Mode, Panoramic, 3D, etc.) at any time during the imaging session and return to 2D
imaging.

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 Patient Name Institution Name & LMP/GA (if applicable)
& ID Fields Transducer – Application – Preset & Operator ID Fields

2D/B-Mode Imaging
Parameters

Cine Loop Frames Indicator Appears RED when cine clip storage in progress.

Note: Refer to 9.1.6 Patient Settings for details on LMP vs. GA selection.

The SONIX broadband transducers provide a range of imaging frequencies:

• Harmonics: (not available with all transducers) Provides artifact reduction
• Resolution: Provides highest frequency/best resolution
• General: Standard imaging frequency for average patients
• Penetration: Provides lowest frequency/most penetration for deep anatomical
structures.

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2D/B-Mode Onscreen Imaging Parameters

Image Optimization: (Harmonics, DEPTH Indicator

Resolution, General, Penetration)
Sector size in % or Ext
FREQ – frequency of transducer (Extended field of
view/trapezoid)
B-Mode Gain
Frames per Second
Frame Rate
Persistence
Dynamic Range
B-Mode Map
Acoustic Power Output
Chroma Map
Mechanical Index
or Thermal Index Clarity = Speckle
Reduction (Off, Med, High)

To adjust the imaging frequency (Image Optimization):

1. Press the FREQ toggle button on the 2D/B-MODE section of the operator console.
2. Press up on the toggle button to increase the 2D imaging transmit frequency
(Resolution).
3. Press down on the toggle button to decrease the 2D imaging transmit frequency
(Penetration).
4. Press up on the toggle button past Resolution to access Harmonics imaging mode.
Note: Availability of this option is transducer dependent.

Additional 2D imaging parameters are available on the touch screen under the “B” mode
tab:

2D /B-Mode Touch Screen Controls: (tap to activate)

Reverse Tap to reverse the image orientation Right/Left.

Invert Tap to invert the image orientation Up/Down.

Tap to display biopsy guidelines.
Biopsy Note: This option is only available for the following transducers: C5-2,
C7-3, EC9-4, L14-5/38 and L14-5/60.

Pano Tap to activate the Panoramic imaging mode.

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 To select/adjust the following touch screen 2D imaging parameters:
1. Select B mode tab from touch screen menu.
2. Tap desired selection (e.g., Persistence) from the touch screen menu.
3. Use the touch screen dial below the column containing the desired selection to make
the adjustment to the imaging parameter (e.g., turn dial left to decrease
Persistence/turn dial right to increase Persistence).

2D/B-Mode Touch Screen Controls: (tap to activate and dial to adjust)

Fr Rate Adjusts the Frame Rate

Adjusts the image Sector size.

Sector Note: Extended Field of View (FOV) and trapezoid imaging if
available.

Focus Span Adjusts the distance between focal zones.

Adjusts the number of transmit focal zones on the screen. The

maximum number of focal zones varies depending on which
Focus # transducer is selected.
Note: Increasing the number of focal zones may reduce the Frame
Rate.

Clarity Adjusts the level of speckle reduction: Off, Med, High.

Adjusts the overall image contrast resolution in 1 dB increments.
Dyn Displayed dynamic range varies from 45dB to 105dB. Complete
(Dynamic Range) system dynamic range is 262dB.
Note: Increase in dB increases the level of greys displayed.

Chroma Adjusts the color of the 2D image: 0 to 4.

Persist Adjusts the level of visual smoothing of the 2D image.

Map Adjusts the grey scale map: 1 to 9.

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 5.0.2 Clarity (Speckle Reduction)

Clarity imaging mode enhances the 2D image by performing adaptive filtering of the image.
Clarity provides improved visibility of real structures with various levels of speckle
reduction: Off, Medium, High. The default Clarity level for most imaging presets is Medium.

To adjust the Clarity (speckle reduction) imaging mode:

1. Tap the 2D/B-mode tab on the touch screen.
2. Tap Clarity on the touch screen menu.
3. Use the touch screen dial below Clarity to adjust the level of speckle reduction. The
Clarity level is stated at the bottom of the 2D imaging parameters listed to the right of
the image field.

5.0.3 Spatial Compound Imaging

To activate Real Time Spatial Compound Imaging:

1. Press SPATIAL COMPOUND at the top of the Operator Console.
2. To exit spatial compound imaging, press SPATIAL COMPOUND.
Note: Spatial Compound Imaging is available as an option with some transducers, but
is not available during Color imaging modes.

5.0.4 2D Zoom Imaging

To activate the Zoom feature:

1. On a live or frozen image, press the ZOOM toggle button up to the desired level of
magnification.
2. Use the trackball to reposition the magnified field of view.
Note: Repositioning of the Zoom field of view is only possible after the image is
magnified off the image field.

3. To reduce the level of magnification, press the ZOOM toggle button down to the
desired level.
4. To exit the zoom feature, press the B-MODE button to return to 2D imaging.

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 5.0.5 Dual Imaging Format

Indicates active side:

Active RT (right)
Active LT (left)

To activate the Dual imaging format:

1. Press DUAL/QUAD once. A live image appears to the right of the image field (Active
RT).
2. Press UPDATE to freeze the Active RT image and unfreeze (i.e., make active) the left
image, in one step.
Note: Instead of pressing UPDATE, press FREEZE to freeze the right image. Pressing
UPDATE will then toggle between the frozen images. Press FREEZE again at
any time to activate the current image.

3. Press UPDATE to toggle back and forth between the dual images, freezing the inactive
image and unfreezing the newly active image.
4. Press B-MODE to exit Dual imaging format.

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 5.0.6 Quad Imaging Format

Note: Color Doppler imaging is available during Dual imaging format. Color Doppler is not
available during Quad imaging format.

Indicates active quadrant:

Active ULT (upper right)
Active URT (upper left)
Active BLT (bottom right)
Active BRT (bottom left)

To activate the Quad imaging format:

1. Press DUAL/QUAD twice to access a live image in the upper left (ULT) quadrant of the
image field.
2. Press UPDATE to freeze the Active ULT image and activate the upper right (URT)
quadrant, in one step.
Note: Instead of pressing UPDATE, press FREEZE to freeze the active image. Press
UPDATE to move to the next quadrant which will also contain a frozen image.
Press FREEZE to activate it or UPDATE to move to the next quadrant.

3. Press UPDATE again to freeze the current image and move to the next quadrant in
one step, freezing the inactive image and creating the newly active image
Note: UPDATE toggles through the images sequentially: ULT, URT, BLT, BRT.

4. Continue pressing UPDATE to page through the four images as required. Depending
on the method selected above (UPDATE only or FREEZE and UPDATE), the images
will be active or frozen, respectively.
5. Press DUAL/QUAD or B-MODE to exit Quad imaging format.

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 5.0.7 M-Mode Imaging Mode

To activate the M-Mode imaging mode:

1. Press the console M-MODE button.
2. A live full screen 2D image appears with an M-mode cursor.
Note Refer to section 9.1.1 System Settings (Imaging Modes) to customize the
M-Mode display settings (side by side, etc.)

3. Use the trackball to position the M-mode zoom location.

4. Use the touch screen dial below M Zoom to adjust the M-Mode magnification.
5. Use the touch screen dial below Sweep to adjust the speed.
6. Use the touch screen dials below Chroma and Map to make any necessary
adjustments.
7. Press M-MODE or B-MODE to exit M-mode imaging mode and return to 2D imaging.

The following M-Mode imaging parameters are available on the touch screen during active
M-mode imaging:

M-Mode Touch Screen Controls: (tap to activate and dial to adjust)

Sweep Adjusts the speed of M-mode Sweep: Low, Medium, High.

Adjusts the amount of M-mode magnification. Use the trackball to

M Zoom
reposition M-zoom location.

Chroma Adjusts the color of the M-mode sweep: 0 to 5.

Map Adjusts the grey scale Map: 1 to 3.

To select/adjust the above touch screen M-Mode imaging parameters:

1. Select M-Mode tab from touch screen menu.
2. Tap desired selection (e.g., Chroma) from the touch screen menu.
3. Use the touch screen dial below the column containing the desired selection to make
the adjustment to the imaging parameter.

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 5.0.8 Cine Clip Storage and Thumbnail Image/Clip Review

Note: Cine clip storage is not available for M-mode and PW. Changes made to depth, gain,
etc., will reset the number of frames available for review or storage. Cine loop
storage is a retrospective acquisition.

Cine Clip Storage:

To store a 2D, 2D/Color or 4D Cine clip:

1. Select FREEZE to freeze the image field and display the Cine touch screen controls.
Tap the Cine tab on the touch screen if not currently active.
Note: Refer to Chapter 6 - 3D/4D Imaging for details on capturing a 4D image.

The following Cine clip storage controls are available on the touch screen with a frozen 2D
or 4D image:

Cine Touch Screen Controls: (tap to activate)

Play Fwd Select to play forward the available cine frames.

Play Rev Select to play in reverse the available cine frames.

Stop Select to stop the cine frames from playing.

Record Select to store the selected cine frames to the system.

Cine Touch Screen Controls: (tap to activate and dial to adjust)

FrmByFrm Fast Use to select currently displayed frame - 10 frames at a time.

FrmByFrm Use to select currently displayed frame - one (1) frame at a time.

Start Fast Use to select start frame for cine clip - 10 frames at a time.

Start Use to select start frame for cine clip – one (1) frame at a time.

End Fast Use to select end frame for cine clip – 10 frames at a time.

End Use to select end frame for cine clip – one (1) frame at a time.

Play Speed Use to select cine play speed (⅛, ¼, ½, full (1) or double (2).

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 To select/adjust the previous touch screen Cine controls:
1. Select Cine tab from touch screen menu.
2. Tap desired selection (e.g., Start Fast) from the touch screen menu.
3. Use the touch screen dial below the column containing the desired selection to make
the adjustment to the cine clip.

Cine Frame Indicators (located at bottom left of the image field on frozen image)

Current Frame/Total # of Frames Available

Start ... End Frames
(Select start and end frames for clip storage).

Appears RED when cine clip

storage is in progress.

Stored Thumbnail Review (displayed at bottom of the LCD display):

To review a thumbnail image/cine clip:

1. Move the trackball arrow over the desired thumbnail and press SELECT.
Note: If the trackball arrow is not available, it may be occupied by other imaging or
measurement modes. To retrieve it, exit the imaging mode completely and then
re-enter.

2. Press SELECT again to return to imaging mode.

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 The following Cine Clip Review controls are available on the touch screen with cine clip review:

Cine Review Touch Screen Controls: (tap to activate)

Select to toggle between two methods of reviewing the stored loop.
Toggle Repeat - Repeat the clip over/loop – indicated by curved arrow
- Stop clip at end – indicated by straight arrow.

Exit Select to exit the clip review and return to 2D imaging.

Play Select to play the clip forward.

Pause Select to pause the stored clip.

Cine Review Touch Screen Controls: (tap to activate and dial to adjust)
FrmByFrm Use to select currently displayed frame – one (1) frame at a time.

Speed Use to select cine review play speed (⅛, ¼, ½, full (1/1) or double (2/2).

To select/adjust the above touch screen Cine Review controls:

1. Select Review tab from touch screen menu.
2. Tap desired selection (e.g., Speed) from the touch screen menu.
3. Use the touch screen dial below the column containing the desired selection to make
the adjustment to the cine review.

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5.1 COLOR/POWER DOPPLER

Color Doppler is used to detect blood flow and determine flow direction. Power Doppler is more
sensitive to low flow rate in small vessels, but offers no directional information. Directional Color
Power Doppler is Power Doppler with a red/blue color map providing directional flow information.

Color Doppler
Imaging Parameters

The key Color/Power Doppler imaging controls are located in the upper center position of the
operator console:

Color Doppler Console Controls:

COLOR button/dial Press to select Color Doppler imaging/turn to adjust Color gain

Press to activate Power Doppler imaging/turn the Color dial to adjust

POWER DOPPLER button
the Power Doppler gain
WF toggle button Press up or down to adjust the Color Wall Filter higher or lower
Press up or down to adjust the Color Doppler Pulse Repetition
PRF toggle button
Frequency (PRF) up or down
INVERT button Press to invert the direction of the color map
Press to steer Color ROI box right or left.
STEER toggle button
Used to steer PW Doppler and 2D linear image field.

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 Additional Color/Power Doppler image optimization controls are available on the touch screen
Color tab when the Color imaging mode is active:

Color Doppler Touch Screen Controls: (tap to activate)

Tap to activate/deactivate simultaneous side-by-side split screen:
Simult 2D/Col
Live 2D/Color – Left side || Live 2D – Right side

Available when PW imaging mode is activated. Tap to activate/deactivate Triplex

Triplex
imaging mode.

To select/adjust the following touch screen Color imaging parameters:

1. Select the Color tab from the touch screen menu.
2. Tap the desired selection (e.g., Persistence) from the touch screen menu.
3. Use the touch screen dial below the column containing the desired selection to make
the adjustment to the imaging parameter (e.g., turn dial left to decrease the amount of
Persistence/turn dial right to increase the amount of Persistence).

Color Doppler Touch Screen Controls: (tap to activate and dial to adjust)
Baseline Adjusts the color Doppler Baseline

Priority Adjusts the color Doppler to 2D Priority

Persistence Adjusts the color Doppler Persistence

Map Adjusts the color Doppler Map. Choose from any of nine (9) different color Maps.

Freq Adjusts the Frequency of the color Doppler

Box Height Adjusts the size of the color ROI box horizontally
Adjusts the image frame rate.
Fr Rate Note: Decreasing the Frame Rate increases the color quality providing higher
color line density. Increasing the Frame Rate decreases the color quality.

Box Width Adjusts the size of the color ROI box vertically

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 5.1.1 Color Doppler Imaging Mode

To activate Color Doppler imaging mode:

1. Press the COLOR button. A live full screen 2D image with Color ROI box is displayed.
2. Use the trackball to position the Color ROI box to the area of interest.
3. Press SELECT to toggle control of the trackball to resize the Color ROI box.
4. Use the trackball to resize the Color ROI box or use the touch screen controls to make
the horizontal and vertical Color ROI box adjustments.
Note: During multiple mode imaging (i.e., 2D/Color/PW Doppler) use the SELECT
button to toggle control of the trackball for color ROI box positioning, color ROI
box resizing and PW cursor /Gate positioning. Alternate controls are available on
the Color tab to resize the color ROI box. The color ROI box moves with the PW
cursor.

5. Press COLOR to exit Color Doppler imaging.

5.1.2 Color Power Doppler Imaging Mode

To activate Color Power Doppler imaging mode:

1. Press the POWER DOPPLER button. A live full screen 2D image with Color Power
ROI box is displayed.
2. Use the trackball to position the Color Power ROI box to the area of interest.
3. Press SELECT to toggle control of the trackball to resize the Color Power ROI box.
4. Use the trackball to resize the Color Power ROI box or use the touch screen controls to
make the horizontal and vertical Color Power ROI box adjustments.
Note: During multiple mode imaging (i.e., 2D/Color/PW Doppler) use the SELECT
button to toggle control of the trackball for color ROI box positioning, color ROI
box resizing and PW cursor /Gate positioning. Alternate controls are available on
the Color tab to resize the color ROI box. The color ROI box moves with the PW
cursor.

5. Press POWER DOPPLER to exit Color Doppler imaging.

5.1.3 Simultaneous 2D/Color and 2D

To activate split screen with simultaneous live 2D/Color and live 2D:
1. Activate color imaging mode.
2. Tap the Color tab on the touch screen.
3. Tap Simult 2D/Color on the touch screen. The live, 2D image with Color is displayed
on the left side of the image field and the same live, 2D image without Color is
simultaneously displayed on the right side of the image field. Freezing the image will
freeze both sides simultaneously.
4. To exit the simultaneous 2D/Color and 2D imaging mode, tap Simult 2D/Color located
on the Color tab on the touch screen.

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5.2 PULSED WAVE (PW) DOPPLER

PW Doppler
Imaging Parameters

Indicates Cine frames actively

available for each imaging mode:
Indicates active imaging mode(s) when unfrozen:
PW (Doppler Trace) Active PW (Doppler Trace)
B (2D with and without color) Active B (B-mode or 2D)
Active B/PW (simultaneous 2D and Doppler Trace)
Press UPDATE button to toggle Active B/C (2D with Color)
control between modes. Triplex

Press UPDATE button to toggle control between modes.

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 The key PW Doppler imaging controls are positioned to the upper left portion of the operator
console:

Doppler Console Controls:

PW button/dial Press to activate PW Doppler mode/turn to adjust PW Doppler gain.
CW button Not available in this release.
BASE toggle button Press up or down to adjust the Doppler trace baseline up or down
PRF toggle button Press up or down to adjust the Doppler PRF up or down
INVERT button Press to invert the direction of the Doppler trace

ANGLE CORRECT Press to toggle between +60, -60 and 0 degree Doppler angle correct
button/dial selections. Turn the dial to make angle corrections in 2 degree increments.
Press to steer Doppler cursor angle right or left. Also used to steer Color
STEER button
ROI box and 2D linear image field.

The Doppler volume control dial is located to the left of the touch screen on the operator console.

Additional PW Doppler imaging parameters are available on the touch screen to optimize the Live
Doppler trace:

Doppler Touch Screen Controls: (tap to activate and dial to adjust)

Activates/deactivates live spectral Doppler trace display with measurement
Trace On/Off
values.

Available when Color imaging mode is activated. Tap to activate/deactivate

Triplex
Triplex imaging mode.

Sweep Adjusts the sweep speed of Doppler trace (Low, Medium, High, Extra High)

Reject Adjusts the Doppler spectrum threshold

Adjusts the PW sample volume gate size
Gate
(Sample Volume) Note: To adjust the Gate size in full screen 2D/PW cursor, turn the PULSED
DOPPLER button dial.

Map Adjusts the gray scale map of the Doppler trace

Chroma Adjusts the chroma (color) map of the Doppler trace (0 to 7)

Freq Adjusts the Doppler transmit frequency

WF (Wall Filter) Adjusts the Doppler wall filter

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 To select/adjust the above touch screen PW Doppler imaging parameters:
1. Select PW Doppler tab from touch screen menu.
2. Tap desired selection (e.g., PW gate size) from the touch screen menu.
3. Use touch screen dial below the column containing the desired selection to make the
adjustment to the imaging parameter (e.g., turn dial left to decrease Gate size/turn dial
right to increase Gate size).

5.2.1 Pulsed Wave (PW) Doppler Imaging Mode

To activate PW Doppler imaging mode:

1. Press the PULSED DOPPLER button. A live full screen 2D image with PW cursor is
displayed.
Note: The default Doppler display settings are 1/3 -2D || 2/3 -trace (“Large Spectrum”)
with full screen 2D/Doppler cursor upon initial activation. Refer to 9.1.1 System
Settings (Imaging Modes) to customize the Doppler display settings.

Note: To adjust the sample volume Gate size in full screen 2D/PW cursor, turn the PW
button/dial.

2. Use the trackball to position the Doppler cursor/gate to the area of interest.
3. Press UPDATE to display a live Doppler trace and a frozen 2D image/cursor.
4. Press UPDATE to toggle back and forth between PW trace and 2D/cursor.
5. Press B-MODE to exit PW imaging mode.

5.2.2 Triplex Imaging Mode

Triplex imaging mode combines live 2D/Color Doppler with live PW or CW Doppler imaging
modes allowing the user to image with 2D/Color and PW or CW Doppler modes
simultaneously.

Caution: Triplex imaging mode may diminish the quality of the 2D/Color image and may
cause Doppler artifacts.

To activate Triplex imaging mode:

1. Activate Color and PW Doppler imaging modes.
2. Tap PW Doppler tab from touch screen menu.
3. Tap Triplex from the touch screen menu.
4. To return to Duplex imaging, tap Triplex from the touch screen menu or press
UPDATE on the operator console.

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5.3 PANORAMIC IMAGING

Panoramic imaging enables the user to generate a panoramic view of the 2D ultrasound image
field – much wider than the typical transducer field of view. Panoramic images are composed of
several standard ultrasound images acquired as the transducer is moved along the anatomical
area of interest in a direction parallel to the transducer array. The resultant compound or composite
image displays a large cross section of the area of interest which can then be viewed, measured,
labeled and archived.

To activate the Panoramic (Pano) imaging mode:

1. Tap Pano on the 2D touch screen during live 2D imaging.
2. A message box appears on the image screen to indicate the “Pano tables are being
loaded”.
Note: This may take a few seconds. The panoramic feature is ready to use when a
white Pano ROI (region of interest) box appears on the 2D image and “Pano
Ready” appears in the lower left corner of the image field.

3. To begin acquiring a panoramic image, position the left side of the anatomical area of
interest within the Pano ROI box.
4. Press UPDATE or tap Start on the touch screen to begin the panoramic acquisition.
5. Move the transducer along a path parallel to the transducer array along the area of
interest. For best results move the transducer at a slow and steady pace.
6. To complete the Pano acquisition, press the FREEZE button on the operator console
or tap Stop on the touch screen.
7. The generated panoramic image appears in the image field.
Note: Pano post-processing parameters are available on the touch screen to rotate or
enlarge the panoramic image.

8. Tap Exit on the touch screen to exit the Panoramic imaging mode and return to 2D
imaging.

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 Caution: Measurements performed on the acquired panoramic image may be
inaccurate as the accuracy of the geometric re-composition is very user-
dependent. Measurements performed on the acquired panoramic image
should be used for informational purposes only.

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CHAPTER 6 - 3D/4D IMAGING

6.0 3D/4D IMAGING

The following 3D/4D imaging parameters are available on the touch screen to optimize the image:

3D/4D Touch Screen Controls: (tap to activate, dial to adjust)

VR Displays only the Volume Rendering of the 3D/4D image.
Displays side-by-side, split-screen view of the Acquisition (A) Plane image with a
A | VR
3D/4D VR of the image.
Displays side-by-side, split-screen view of the Coronal (C) Plane image with a
C | VR
3D/4D VR of the image.
A|B Displays the A, B (Transverse) and C planes images along with a 3D/4D VR of
C | VR the image.
Reset Returns many settings to their default.
Exit Exits 3D/4D imaging.
Tap and dial to adjust the Quality of the image(s). There are three (3) available
levels: Low Medium and High.
Quality Quality, in conjunction with the FOV, creates the Volumes per Second (VPS)
setting recorded on the bottom of the LCD display for 4D images only.
Note: Not available for 3D Freehand. This setting is not affected by Reset.
3D/4D Main

Tap and dial to adjust the Field of View (FOV) of the rendered 3D/4D image. This
setting ranges from 5° to 60° (in 5° increments) and is tracked across the bottom
of the LCD display (4D images only).
FOV FOV, in conjunction with the Quality, creates the Volumes per Second (VPS)
setting recorded on the bottom of the LCD display for 4D images only.
Note: Not available for 3D Freehand. This setting is not affected by Reset.

Tap and dial to suppress image artifacts or noise with a Threshold adjustment.
Reset applies to this option.
Threshold
Note: The dynamic range of the image will be optimized automatically based on
the selected Threshold setting.

Adjusts image Transparency settings on the LCD display. Reset applies to this
Transp
option.
X-axis Rotates the selected image about the X-axis.
Y-axis Rotates the selected image about the Y-axis.
Z-axis Rotates the selected image about the Z-axis.
Sets the Orientation of the VR. Reset applies to this option.
VR Orient Note: This setting is tracked under Current Display on the right hand side of the
LCD display.

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 Note: 3D/4D Display, Sculpt… options (below) cannot be applied during image acquisition.
During 4D image acquisition, if the Sculpt… option is selected without pressing the console
FREEZE button, image acquisition will be suspended, although the 4D transducer will
continue to operate. Once the user exits Sculpt…, image acquisition will resume.

Lasso Traces a freehand Lasso around the desired area and deletes all items
(inside) inside the shape.

Lasso Traces a freehand Lasso around the desired area and deletes all items
(outside) outside the shape.

Rect Traces a Rectangle around the desired area and deletes all items inside the
(inside) shape.

Rect Traces a Rectangle around the desired area and deletes all items outside
(outside) the shape.

Ellipse Traces an Ellipse around the desired area and deletes all items inside the
(inside) shape.
Sculpt …
3D/4D Advanced

Ellipse Traces an Ellipse around the desired area and deletes all items outside the
(outside) shape.
Undoes all the edits made during the session.

Undo All Note: A session is considered ended once the user exits Sculpt….
Re-entering Sculpt… is considered a new session even if the same
image is being edited.

Undo Last Undoes the edits made during the session, one at a time, in reverse order.

Exit Exits Sculpt….

Sets the Orientation of the selected image.
VR Orient Note: This setting is tracked under Current Display on the right hand side of
the LCD display.

X-axis Rotates the selected image about the X-axis.

Y-axis Rotates the selected image about the Y-axis.

Z-axis Rotates the selected image about the Z-axis.

Displays the actual slices of the 3D image as determined by the A, B and C

Slice Lines planes. To view their position without Slice Lines selected, turn on
Reference Planes.
3D/4D Display

Displays the positioning of the 3-dimensional planes as they would appear in

Reference
the VR or MPR Rendering, without actually “slicing” the planes through the
Planes
image. To view the actual slices, turn on Slice Lines.

Boundary Box Inserts a yellow, 3D box that represents the outer edges of the 3D/4D data.
Axes Displays the color-coded axes markers through the VR image.

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 Save Once the settings have been adjusted as desired, tap to save as a user-
New Preset defined 3D/4D Preset.

Tap and dial to adjust the Quality of the VR image. There are three (3)
available levels: Low, Medium and High.
Quality Quality, in conjunction with FOV, creates the Volumes per Second (VPS)
setting recorded on the bottom of the LCD display for 4D images only.
Note: Not available for 3D Freehand. This setting is not affected by Reset.

Tap and dial to adjust the Field of View (FOV) of the rendered 3D/4D image.
This setting ranges from 5° to 60° (in 5° increments) and is tracked across
the bottom of the LCD display (4D images only).
FOV FOV, in conjunction with Quality, creates the Volumes per Second (VPS)
setting recorded on the bottom of the LCD display for 4D images only.
Note: Not available for 3D Freehand. This setting is not affected by Reset.

Tap and dial to adjust the color of the LCD display Background. This setting
has a range of 01 to 100, inclusive, where 01 is the darkest and 101 is the
Background lightest.
3D/4D Display cont’d

Note: This setting is tracked under Current Display on the right hand side of
the LCD display. This setting is not affected by Reset.

Adjusts VR image Contrast settings on the LCD display. Reset applies to

Contrast
this option.
Tap and dial to adjust the coloration of the VR image using pre-defined color
maps. The range for this setting is 01 to 19, inclusive. Reset applies to this
VR Map option.
Note: This setting is tracked under Current Display on the right hand side of
the LCD display.

Tap and dial to adjust the smoothness of the rendered 3D/4D image. This
setting ranges from 0 to 3, inclusive and is tracked across the bottom of the
Smooth LCD display (4D images only).
Note: Not available for 3D Freehand. This setting is not affected by Reset.

Tap and dial to adjust the coloration of the MPR images using pre-defined
color maps. The range for this setting is 01 to 34, inclusive. Reset applies to
MPR Map this option.
Note: This setting is tracked under Current Display on the right hand side of
the LCD display.

Tap and dial to adjust the position from which the VR is viewed. There are six
(6) positions available: Top, Bottom, Left, Right, Front, Back. Reset
VR View applies to this option.
Note: This setting is tracked under Current Display on the right hand side of
the LCD display.

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 Once a 3D/4D image has been captured, there are several editing parameters are available on the
LCD display.

Sample 3D/4D Image Display

Current Display
options are controlled
via the touch screen

Visualization options
are controlled via the
LCD display.

Image Quadrants

Green: Acquisition (A) Plane Blue: Transverse (B) Plane

Perpendicular to the Acquisition Plane

Red: Coronal (C) Plane Volume Rendering (VR)

Parallel to the Acquisition Plane
AND/OR
MPR Rendering

Note: 4D images default to the A|VR dual image screen.

Note: For more information on adjusting the items in Current Display, refer to the appropriate
fields in the tables above.

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 Transverse
Plane

X
Z Acquisition
Plane

C-Plane
Initial
Viewpoint

This diagram demonstrates the various planes and axes of a 3D image once it has been acquired
and before any changes are made to it. Remember that once an image has been edited (e.g., the
MPR ROI has been altered) the positions of the planes shown here will have been altered as well.
Once changes have been made, use the touch screen Reset button on 3D/4D Main to return the
image to its original geometric position.

Note: Using Reset will also return other settings to their original positions, including: Threshold,
VR View and Contrast.

3D/4D Visualization options (edit using trackball and console SELECT button)
Select to view the Region of Interest (ROI) in each view of the image. By default,
this field will be selected after every image capture.
3D Rendering

Note: Enable MPR ROI cannot be selected at the same time as Section Plane.
Enable
MPR ROI Select the radio button for Position to adjust the positioning of the image in
relation to the ROI. The Position ROI is comprised of solid lines.
Select the radio button for Size to adjust the size of the ROI. The Size ROI is
comprised of dotted lines.
Section Planes

Select Section Planes to view to the intersection point of all planes on the VR or
MPR Rendering.
Show VR Note: Section Planes cannot be selected at the same time as Enable MPR ROI.
Select Show VR to adjust the intersection point of all planes on the VR or MPR
Rendering.

Exit Select to exit the current editing session.

Note: To move a selected item (e.g., the Acquisition Plane ROI) use the trackball to position the
cursor then hold down the SELECT button continuously and use the trackball to drag the
desired item to its new position. Release the SELECT button to complete the action.

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 6.0.1 Freehand 3D Imaging (All Non-4D SONIX Transducers)

Configuration for freehand 3D imaging is controlled through System Setup (9.0.7 3D

Settings). The 3D Config dialog box may be configured to appear after image acquisition
or not to display at all, in which case the freehand imaging parameters are controlled via
the touch screen, before image acquisition.

Freehand 3D image acquisition is accomplished using either a Parallel or Fan transducer

motion.

Freehand 3D Image Configuration Options (via touch screen/dial or dialog box)

Select Parallel as the Scan Type to measure a linear path in centimeters.
The default setting is 10 cm. The selection range is 1 cm to 25 cm, with
Parallel adjustments available in 1 cm increments
Note: Slide the transducer along a linear path.

Select Fan as the Scan Type to measure a pivot angle in degrees. The
default setting is 40°. The selection range is 5° to 90°, with adjustments
Fan available in 5° increments
Note: Pivot the transducer in a rocking motion.

To obtain a freehand, 3D image with configuration BEFORE acquisition:

1. Press 3D/4D at the top of the operator console.
2. If a Preset other than default is required, tap that Preset name on the touch screen.
3. Turn the dial below Scan Type to select either Parallel or Fan.
4. Tap Value and turn its associated dial to select a Value for Length or Angle
Note: The Value type (Length vs. Angle) will change depending on the Scan Type
selection made in the previous step.

5. Position the transducer to one side of the anatomical area of interest.

6. Press UPDATE to begin the acquisition.
7. Move the transducer over the area of interest in a motion relevant to the Scan Type
selection made in Step 2, above (Parallel or Fan).
8. Press the console FREEZE button to complete the 3D freehand acquisition.
Note: If the process takes too long, the system will complete the image automatically
before the FREEZE button is pressed. The following explanation will be
presented in a message bubble.

9. The acquired 3D image will be rendered to the LCD display in the A|B|C|VR format.
Note: Use the 3D/4D Main touch screen selections to change the viewing format.

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 To obtain a freehand 3D image with configuration AFTER acquisition:
1. Press 3D/4D at the top of the console.
2. On the touch screen, tap the desired Preset name.
3. Position the transducer to one side of the anatomical area of interest.
4. Press UPDATE to begin the acquisition.
5. Move the transducer over the area of interest in either a Parallel or Fan motion.
6. Press the console FREEZE button to complete the freehand 3D acquisition.
Note: If the process takes too long, the system will complete the image automatically
before the FREEZE button is pressed. The following explanation will be
presented in a message bubble.

7. Use the trackball and SELECT button to choose the freehand Scan Type from the 3D
Config dialog box: Parallel or Fan.

8. Select the appropriate Length/Angle setting from the drop down menu.
9. Select OK to complete the configuration.
10. The acquired 3D image will be rendered to the LCD display in the A|B|C|VR format.
Note: Use the 3D/4D Main touch screen selections to change the viewing format.

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 6.0.2 3D Imaging (SONIX 4D Transducer)

To obtain a 3D image with a SONIX 4D transducer:

1. Press the console PROBE button to view a list of available transducers on the touch
screen.

Caution: The 4D transducer MUST be inserted into the upper most transducer
connection port to ensure proper function. Refer to section 3.1 for details on
connecting transducers.

2. Tap the appropriate transducer on the touch screen.

3. Tap the Presets tab.
4. Tap the desired Application.
5. Tap the desired Preset.
6. Press the console 3D/4D button.
7. Tap the 3D button on the touch screen.
8. Position the 4D transducer over the area of interest.
9. Press UPDATE to begin the acquisition.
Note: Hold the transducer steady while the image is being acquired.

10. The acquired 3D rendering with its associated views will be presented on the LCD
display.
Note: See 6.0.5 3D/4D Image Formats for the LCD Display for details on image
views.

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 6.0.3 4D Imaging (SONIX 4D Transducer)

To obtain a 4D image using a SONIX 4D transducer:

1. Press the console PROBE button to view a list of available transducers on the touch
screen.
2. Tap the appropriate 4D transducer on the touch screen.
3. Press the console 3D/4D button.
4. Position the 4D transducer over the area of interest.
5. Press UPDATE to begin the acquisition.
6. The acquired 4D rendering with its associated Acquisition Plane will be presented on
the LCD display.
7. Slowly move the transducer over the area of interest.
8. Press the console FREEZE button to complete the acquisition.
Note: See 6.0.5 3D/4D Image Formats for the LCD Display for details on image
views.

6.0.4 4D-Specific LCD Display Details

Cine

When a 4D image is acquired, the LCD display will have an additional line across the
bottom. These settings are not available onscreen with 3D images.
For details on manipulating the Cine options, refer to 5.0.8 Cine Clip Storage and
Thumbnail Image/Clip Review.
For details on the FOV, Quality and Smooth settings, refer to the 3D/3D Display Options
table on page 53.
The VPS (Volumes per Second) setting is automatically calculated based on the Quality
and/or FOV settings, located on both the 4D Main and 4D Display tabs of the touch
screen.
The MI (Mechanical Index) is displayed for informational purposes only.

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 6.0.5 3D/4D Image Formats for the LCD Display

There are four different image formats available for the LCD display: VR, A|VR, e and
A|B|C|VR.

After acquiring a 3D freehand or 3D image, the LCD display will default to the A|B|C|VR
option, while a 4D acquisition will default to A|VR.

VR A|VR (4D Default)

C|VR A|B|C|VR (3D Default)

Note: If the Show VR radio button is not selected in the Visualization menu on the LCD
display, then the MPR Rendering will be displayed in place of the VR image.

MPR Rendering Accompanying Current Display Settings

The combination of the

VR Orient and VR View
settings determine the
initial presentation of the
MPR Rendering.

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 To change the format of a rendered 3D/4D image on the LCD display:
1. Tap the 3D or 4D tab from touch screen menu.
2. Make the appropriate selection on the 3D/4D Main touch screen panel: VR, A|VR,
C|VR or A|B|C|VR.
Note: The Image format can also be changed during 4D image acquisition. Refer to
page 67 for details on optimizing a 4D image during acquisition.

6.0.6 Optimizing a 3D Image

A 3D image can only be optimized after it has been acquired. Both the image and its
environment can be optimized in several ways, including: Quality*, Display*, Threshold,
Transparency, VR Orient, Background, Contrast, VR Map, Smooth*, MPR Map and VR
View.
For a comprehensive list of options for editing a 3D image and its environment, please refer
to the tables beginning on page 53.
Note: Options marked with an asterisk (*) are not available for 3D Freehand images.

To optimize a 3D image AFTER acquisition:

1. Follow the directions in section 6.0.1 or 6.0.2 to acquire a 3D Freehand or 3D image.
2. Once the image has been rendered to the screen, tap 3D/4D Main on the touch
screen.
3. Tap the desired image format: VR, A|VR, C|VR or A|B|C|VR.
4. Tap the desired tab on the touch screen: 3D/4D Main, 3D/4D Advanced or 3D/4D
Display.
5. Tap/dial to make the necessary changes, tapping page tabs to move through the touch
screens as necessary.
6. To adjust the Visualization options on the LCD display, use the trackball and console
SELECT button to check the 3D Rendering radio button.
7. Check Enable MPR ROI, then the Position radio button to adjust the location of the
ROI rectangle (solid line).

8. Press the console SELECT button, then use the trackball to drag the image to the
desired position (in either the A, B or C Plane).
9. Press SELECT again to lock in the position of ROI rectangle.

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 10. To change the size of the ROI rectangle (dotted line), check the Size radio button.
11. Press the console SELECT button, then use the trackball to drag the ROI rectangle to
the desired dimension (in either the A, B or C Plane).
12. Press SELECT again to lock in the size of ROI rectangle.
13. To view/edit the intersection point of all planes on the image, use the trackball and
console SELECT button to check the (Visualization option) Section Planes radio
button on the LCD display.

Note: Select the Show VR check box or not as desired.

The plane shown is controlled by the combined settings of VR View and VR
Orient which are listed to the right under Current Display (e.g., VR Orient =
270° and VR View = Top).

14. To move the intersection point of the Section Planes, move the cursor over the right
hand (or bottom right hand) image on the LCD display.
15. Press and hold the console SELECT button then use the trackball to drag the image’s
Section Planes to the desired intersection point.
Note: To make it easier to determine the location of the intersection point, tap 3D/4D
Display and turn on/off any combination of Slice Lines, Reference Planes,
Axes or the Boundary Box

16. Release the SELECT button once the desired affect has been achieved.
Note: If desired, the image can be set to rotate freely. Refer to 6.0.8 3D/4D Active
Rotation for details on this functionality.

17. To undo the changes made to the image, tap Reset on 3D/4D Main.
Note: Reset will return many, but not all, settings to their original positions.

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 6.0.7 Optimizing a 4D Image

A 4D image can be optimized during acquisition, or after it has been acquired. Both the
image and its environment can be optimized in several ways, including: Quality, Display,
Threshold, Transparency, VR Orient, Background, Contrast, VR Map, Smooth, MPR Map
and VR View.
For a comprehensive list of options for editing a 4D image and its environment, please refer
to the tables beginning on page 53.

To optimize a 4D image AFTER acquisition:

1. Follow the directions in 6.0.3 to obtain a 4D image.
2. Once the image has been rendered to the screen, tap 4D Main on the touch screen.
3. Tap the desired image format: VR, A|VR, C|VR or A|B|C|VR.
4. Tap the desired tab on the touch screen: 4D Main, 4D Advanced or 4D Display.
Note: Once a 4D image has been acquired, the touch screen will have a fourth tab:
Cine. Refer to 5.0.8 Cine Clip Storage and Thumbnail Image/Clip Review for
details on Cine manipulation.

5. Tap/dial to make the necessary changes, tapping page tabs to move through the touch
screens as necessary.
6. To adjust the Visualization options on the LCD display, use the trackball and console
SELECT button to check the 3D Rendering radio button.
7. Check Enable MPR ROI, then the Position radio button to adjust the location of the
ROI rectangle (solid line).

8. Press the console SELECT button, then use the trackball to drag the image to the
desired position (in either the A, B or C Plane).
9. Press SELECT again to lock in the position of ROI rectangle.
10. To change the size of the ROI rectangle (dotted line), check the SIZE radio button.
11. Press the console SELECT button, then use the trackball to drag the ROI rectangle to
the desired dimension (in either the A, B or C Plane).
12. Press SELECT again to lock in the size of ROI rectangle.

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 13. To view/edit the intersection point of all planes on the image, use the trackball and
console SELECT button to check the (Visualization option) Section Planes radio
button on the LCD display.

Note: Select the Show VR check box or not as desired.

The plane shown is controlled by the combined settings of VR View and VR
Orient which are listed under Current Display (e.g., VR Orient = 270° and VR
View = Top).

14. To move the intersection point of the Section Planes, move the cursor over the right
hand (or bottom right hand) image on the LCD display.
15. Press and hold the console SELECT button then use the trackball to drag the image’s
Section Planes to the desired intersection point.
Note: To make it easier to determine the location of the intersection point, tap 3D/4D
Display and turn on/off any combination of Slice Lines, Reference Planes,
Axes or the Boundary Box.

16. Release the SELECT button once the desired affect has been achieved.
Note: If desired, the image can be set to rotate freely. Refer to 6.0.8 3D/4D Active
Rotation for details on this functionality.

17. To undo the changes made to the image, tap Reset on 3D/4D Main.
Note: Reset will return many, but not all, settings to their original positions.

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 To optimize a 4D image DURING acquisition:
1. Follow the directions in 6.0.3 to obtain a 4D image, but do NOT freeze the image,
instead, simply allow it to keep acquiring data.
2. Tap 4D Main on the touch screen.
3. Tap the desired image format: VR, A|VR, C|VR or A|B|C|VR.
4. Tap the desired tab on the touch screen: 4D Main, 4D Advanced or 4D Display. Once
the touch screen page presents the desired options, tap/dial to make the necessary
changes.
Note: 4D Advanced Sculpt… options cannot be applied during image acquisition.
During 4D acquisition, if the Sculpt… option is selected without pressing the
console FREEZE button, image acquisition will be suspended, although the 4D
transducer will continue to operate. Once the user exits Sculpt…, image
acquisition will resume.

5. Tap/dial to make the necessary changes, tapping page tabs to move through the touch
screens as necessary.
6. To adjust the Visualization options on the LCD display, use the trackball and console
SELECT button to check the 3D Rendering radio button.
7. Check Enable MPR ROI, then the Position radio button to adjust the location of the
ROI rectangle (solid line).

8. Press the console SELECT button, then use the trackball to drag the image to the
desired position (in either the A, B or C Plane).
9. Press SELECT again to lock in the position of ROI rectangle.
10. To change the size of the ROI rectangle (dotted line), check the SIZE radio button.
11. Press the console SELECT button, then use the trackball to drag the ROI rectangle to
the desired dimension (in either the A, B or C Plane).
12. Press SELECT again to lock in the size of ROI rectangle.

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 13. To view/edit the intersection point of all planes on the image, use the trackball and
console SELECT button to check the (Visualization option) Section Planes radio
button on the LCD disaply.

Note: Select the Show VR check box or not as desired.

The plane shown is controlled by the combined settings of VR View and VR
Orient which are listed under Current Display (e.g., VR Orient = 270° and VR
View = Top).

14. To move the intersection point of the Section Planes, move the cursor over the right
hand (or bottom right hand) image on the LCD display.
15. Press and hold the console SELECT button then use the trackball to drag the image’s
Section Planes to the desired intersection point.
Note: To make it easier to determine the location of the intersection point, tap 3D/4D
Display and turn on/off any combination of Slice Lines, Reference Planes,
Axes or the Boundary Box.

16. Release the SELECT button once the desired affect has been achieved.
Note: If desired, the image can be set to rotate freely. Refer to 6.0.8 3D/4D Active
Rotation for details on this functionality.

17. To undo the changes made to the image, tap Reset on 3D/4D Main.
Note: Reset will return many, but not all, settings to their original positions.

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 6.0.8 3D/4D Active Rotation

If desired, the VR or MPR Rendering can be set to spin on 3D Freehand, 3D and 4D

images.

To initiate/end 3D/4D Active Rotation

1. Follow the directions in 6.0.1, 6.0.2 or 6.0.3 to obtain a 3D Freehand, 3D or 4D image.
Note: Active Rotation can also be done during the acquisition of a 4D image. The 4D
image that is set to rotate will be static and although the 4D transducer will
continue to function, it is not acquiring data. Once Active Rotation is stopped,
the 4D transducer will once again begin to acquire a live 4D image.

2. Tap 3D/4D Main on the touch screen.

3. Tap the desired image format: VR, A|VR, C|VR or A|B|C|VR.
4. Tap the desired tab on the touch screen: 3D/4D Main, 3D/4D Advanced or 3D/4D
Display. Once the touch screen page presents the desired options, tap/dial to make
the necessary changes.
5. To initiate Active Rotation, press and hold the console SELECT button.
6. Keep the trackball moving when releasing the console SELECT button.
Note: The trackball’s speed and angle of movement will determine the rotation’s speed
and angle of movement.

7. To end Active Rotation, position the cursor over the rotating image and press the
console SELECT button.
8. Ensure that the track ball is stationary, then release the SELECT button.
9. The image will once again be stationary, however, the image will remain in whatever
position it was in just prior to freezing it. It will not return to its original position unless
the 3D/4D Main Reset button is tapped.
Note: Reset will return many, but not all, settings to their original positions.

Sample VR Image with Axes, Boundary Box and Reference Planes

Axes: green, blue and red arrows.

Boundary Box: exterior yellow box.

Reference Planes: green, blue and

red boxes.

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 6.0.9 4D and Cine

Once a 4D image has been acquired, the touch screen will have a fourth tab: Cine. Refer
to 5.0.8 Cine Clip Storage and Thumbnail Image/Clip Review for details on Cine
manipulation.
Note: A 4D image must be frozen before the Cine option can be applied.

6.0.10 User-Defined Presets for 3D/4D

As with other imaging formats, user-defined 3D/4D Presets can be designed/saved for
future use.
During imaging, a user-defined Preset name is shown on the LCD display in square
brackets (e.g., [User-Defined Preset]). On the touch screen, user-defined presets are
presented in italics (e.g., User-Defined Preset).
All available 3D/4D Presets (both factory default and user-defined) are listed under User
Settings, Presets. Refer to 9.0.4 Imaging Presets – 3D/4D for more details.

Note: Unlike other user-defined Presets, renaming or deleting user-defined 3D/4D Presets
is handled through User Settings, 3D. Refer to 9.0.7 3D Settings for details.

To save a user-defined 3D Preset during freehand, 3D image acquisition:

1. Obtain a 3D freehand image, following the steps detailed in either of the two sets of
instructions (page 58 or page 59).
Note: It doesn’t matter if 3D freehand image configuration is done before or after the
image is acquired.
2. To save the image configurations as a Preset, tap the 3D Display tab in the touch
screen.
3. Tap Save New Preset.

4. Use the keyboard to type in a Preset Name.

Note: Duplicate Preset Names are not allowed. If a duplicate name is entered, the
system will present the Invalid Preset Name warning bubble. If this happens,
use the trackball and console SELECT button and press Cancel to exit, or type
in a different name and press OK to accept it.

5. Use the trackball and console SELECT button to press OK to accept the Preset name
or Cancel to exit without saving.

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 To save a user-defined 3D Preset after image acquisition:
1. Obtain a 3D image, following the steps detailed in 6.0.2 3D Imaging (SONIX 4D
Transducer).
2. Optimize the image as required (6.0.6 Optimizing a 3D Image).
3. Tap the 4D Display tab.
4. Tap Save New Preset.

5. Use the keyboard to type in a Preset Name.

Note: Duplicate Preset Names are not allowed. If a duplicate name is entered, the
system will present the Invalid Preset Name warning bubble. If this happens,
use the trackball and console SELECT button and press Cancel to exit, or type
in a different name and press OK to accept it.

6. Use the trackball and console SELECT button to press OK to accept the Preset name
or Cancel to exit without saving.

To save a user-defined 4D Preset after image acquisition:

1. Obtain a 4D image, following the steps detailed in 6.0.3 4D Imaging (SONIX 4D
Transducer).
2. Optimize the image as required (6.0.7 Optimizing a 4D Image).
3. Tap the 4D Display tab.
4. Tap Save New Preset.

5. Use the keyboard to type in a Preset Name.

Note: Duplicate Preset Names are not allowed. If a duplicate name is entered, the
system will present the Invalid Preset Name warning bubble. If this happens,
use the trackball and console SELECT button and press Cancel to exit, or type
in a different name and press OK to accept it.

6. Use the trackball and console SELECT button to press OK to accept the Preset name
or Cancel to exit without saving.

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CHAPTER 7 - CLINICAL ANALYSIS

Measurements provide the user with the functionality to perform clinical analysis on an ultrasound image.
They range from simple measurements that calculate length, circumference, area, volume, etc., to
measurement packages that use calculation formulas to determine fetal age, heart rate, etc.
The reporting feature takes the application specific measurement values and generates a report
document. This document contains patient information, facility information, labeled measurement values
and calculation results. Some reports may contain auto-generated graphs.
The SONIX system provides both Basic and application-specific measurement/calculation packages. The
following measurement/calculation packages are available:
• Obstetrics: Fetal Biometry, Early OB and AFI
• Pelvic: Pelvic, Lt Follicle and Rt Follicle
• Vascular: 2D Vascular
• Cardiac: Ao/LA/LVO and Lt Ventricle
• Urology: Prostate, PreV Blad, PostV Blad, Rt Kidney, Lt Kidney
• Basic: Dist, Area “|”, Volume,% Area Red “|”, % Diam Red.
The measurement/calculation package defaults to the clinical application selected (i.e., Obstetrical
calculation package is the default when the Obstetrics application is selected). To access measurements
specific to an alternate clinical application tap Select App on the touch screen.
Notes:
• On a frozen image use the MEASURE button to activate the Measurements package.
• To view a report page (if available), tap Report from the Measurements touch screen. Tap Exit
Report to exit the report page.
• When several methods of performing a measurement are available a “‹‹|››” appears on the touch
screen key. Tap the selected measurement key on the touch screen and turn the dial beneath the
selection to select the preferred method. The method selected appears in a message bubble on
the lower right corner of the LCD display. The method selected becomes the default.

(i.e., for percent area reduction) % Area Red

‹‹ | ››

% Area Reduction measurements set

to Ellipse for outer and Ellipse for inner.

• Press the console DEL button (to the left of the MEASURE button) to remove the measurements
from the screen. If saved to report, DEL will remove the measurement from the report. Continue
to press DEL for each of the measurements to be deleted.
• Press the MEASURE button to remove all the measurements on a frozen image screen. Pressing
MEASURE does not delete the measurements from the report.
• Use the SELECT button to select, set and activate calipers, ellipse, etc.
• Use the UPDATE button to toggle between the calipers prior to finalize (set) the measurement.
• Use the keyboard BSP (backspace) key to correct an incorrect move on a trace measurement.

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7.0 2D BASIC MEASUREMENTS

The 2D basic measurements are accessible by tapping Basic on the touch screen when the
Measurement feature is active.

7.0.1 2D Linear Measurement

To perform a linear measurement:

1. With a frozen 2D image press MEASURE button located above the trackball.
2. A caliper will appear on the image on the LCD display. Use the trackball to position the
first caliper.
3. Press SELECT button to set the first caliper and activate the second caliper. Use the
trackball to position the second caliper.
4. To reposition the first caliper press the UPDATE key to toggle control between the two
calipers.
5. Press SELECT to set the measurement. The measurement value will appear on the
bottom of the LCD display.

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 7.0.2 Area or Circumference (Area/Circ) Measurement

There are two methods of performing the area/circumference measurement: Ellipse and
Trace.

7.0.2.1 Trace Method Area or Circumference Measurement

To perform a Trace Method area or circumference measurement:

1. With a frozen 2D image press MEASURE button located above the trackball.
2. If the Basic measurement tab is not active on the touch screen, tap Basic on the touch
screen to activate it.
3. A caliper will appear on the image on the LCD display.
4. To select the desired method, tap Area/Circ on the touch screen and turn the dial
directly below Area/Circ touch screen button until the desired method flashes on the
lower right portion of the LCD display (e.g., “SONIX – Calcs Area set to “Continual
Trace”).
5. Use the trackball to position the caliper at the start position.
6. Press SELECT to set the first caliper.
Note: Use the keyboard BSP key to delete the previous trace move/position. Press
BSP several times to undo several previous positions. Alternatively, use DEL,
located next to the MEASURE button.

7. Use the trackball to trace the circumference the area of interest.

8. Press SELECT to set the trace.
9. The area and circumference values will appear on the bottom right of the LCD display.

7.0.2.2 Ellipse Method Area or Circumference Measurement

To perform an Ellipse Method area or circumference measurement

1. With a frozen 2D image press MEASURE button located above the trackball.
2. If the Basic measurement tab is not active on the touch screen, tap Basic on the touch
screen to activate it.
3. A caliper will appear on the image on the LCD display.
4. To select the desired method, tap Area/Circ on the touch screen and turn the dial
directly below Area/Circ until the desired method flashes on the lower right portion of
the LCD display (e.g., “SONIX Calcs – Area set to “Ellipse””).
5. Use the trackball to position the first caliper.
6. Press SELECT to set the caliper position and activate the second caliper of the ellipse.
7. Use the trackball to position the second caliper.
8. Press SELECT to set the second caliper position and activate the ellipse sides.

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 9. Use the trackball to increase/decrease the sides of the ellipse.
Note: Press UPDATE to toggle control of the calipers/ellipse prior to completion of
ellipse measurement.

10. Press SELECT to complete the ellipse measurement.

11. The area and circumference values will appear on the bottom right of the LCD display.

7.0.3 Volume Calculation

To perform a volume calculation:

1. With a frozen 2D image press MEASURE button located above the trackball.
2. A caliper will appear on the image on the LCD display.
3. If the Basic measurement tab is not active on the touch screen, tap Basic on the touch
screen to activate it.
4. Tap Volume on the touch screen. A second touch screen menu appears with L
(Length), H (Height) and W (Width).
5. Tap L, H or W to activate the first set of calipers for the Volume calculation.
6. Use the track ball to position the first caliper.
7. Press SELECT to set the caliper position and activate the second caliper.
Note: Press UPDATE to toggle control of the calipers prior to completion of each linear
measurement.

8. Use the trackball to position the second caliper.

9. Press SELECT to set the second caliper position and complete the measurement.
Note: On the touch screen, an asterisk beside the L, H or W indicates that that specific
measurement has been completed.

10. Repeat steps 5 through 9 until all three linear measurements have been completed.
The three measurement values with volume results appear on the bottom right of the
LCD display.
11. Tap Cancel to exit the volume calculation sequence.
Notes:
• All three measurements must be completed to calculate the volume
• The measurements will remain on the LCD display between freeze and unfreeze
until the volume calculation is complete.

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 7.0.4 Percent Diameter Reduction Calculation (% Diam Red)

To perform a % diameter reduction:

1. With a 2D frozen image press MEASURE button located above the trackball.
2. A caliper will appear on the image on the LCD display.
3. If the Basic measurement tab is not active on the touch screen, tap Basic on the touch
screen to activate it.
4. Tap % Diam Red on the touch screen.
Note: The first caliper set is used for the outer measurement of the % diameter
reduction and the second caliper set is used for the inner measurement.

5. Use the trackball to position the first caliper of the outer measurement.
6. Press SELECT to set the caliper position and activate the second caliper of the outer
measurement.
Note: Press UPDATE to toggle control of the calipers prior to completion of linear
measurement.

7. A second caliper appears on the LCD display. Use the trackball to position the second
caliper of the outer measurement.
8. Press SELECT to set the second caliper.
9. Use the trackball to position the first caliper of the inner measurement.
10. Press SELECT to set the caliper position and activate the second caliper of the inner
measurement.
11. A second caliper appears on the LCD display. Use the trackball to position the second
caliper of the inner measurement.
12. Press SELECT to set the second caliper.
13. The resulting % Diameter Reduction appears on the bottom right of the LCD display
along with the inner and outer diameter measurements that were used in the
calculation.

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 7.0.5 Percent Area Reduction Calculation (% Area Red)

Two methods of performing the outer and inner % area reduction measurements are
available – ellipse and trace.
To select the desired method, tap % Area Red on the touch screen and turn the dial below
it. The selected method appears in a message bubble on the lower right portion of the LCD
display.

Note: The first caliper set is used for the outer measurement of the % Area Reduction and
the second caliper set is used for the inner measurement.

Ellipse/Ellipse Uses the “Ellipse” method for both outer and inner measurements.

Uses the “Ellipse” method for the outer measurement and the “Trace”
Ellipse/Trace
method for the inner measurement.
Trace/Trace Uses the “Trace” method for both outer and inner measurements.

Uses the “Trace” method for the outer measurement and the “Ellipse”
Trace/Ellipse
method for the inner measurement.

7.0.5.1 Ellipse/Ellipse Method of Percent Area Reduction Calculation (% Area Red)

To perform an Ellipse/Ellipse Method % area reduction:

1. With a 2D frozen image press MEASURE button located above the trackball.
2. A caliper will appear on the LCD display.
3. If the Basic measurement tab is not active on the touch screen, tap Basic on the touch
screen to activate it.
4. Tap % Area Red on the touch screen.
5. Turn the touch screen dial directly below % Area Red and select “Ellipse/Ellipse”.
6. Use the trackball to position the first caliper of the outer ellipse.
7. Press SELECT to set the caliper position and activate the second caliper of the outer
ellipse.
8. Use the trackball to position the second caliper.
9. Press SELECT to set the second caliper position and activate the outer ellipse sides.
10. Use the trackball to increase/decrease the sides of the outer ellipse.
Note: Press UPDATE to toggle control of the calipers/ellipse prior to completion of
ellipse measurement.

11. Press SELECT to complete the outer ellipse measurement.

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 12. Use the trackball to position the first caliper of the inner ellipse.
13. Press SELECT to set the caliper position and activate the second caliper of the inner
ellipse.
14. Use the trackball to position the second caliper.
15. Press SELECT to set the second caliper position and activate the inner ellipse sides.
16. Use the trackball to increase/decrease the sides of the inner ellipse.
17. Press SELECT to complete the inner ellipse measurement.
18. The resulting % Area Reduction appears on the bottom right of the LCD display along
with the inner and outer measurements that were used in the calculation.

7.0.5.2 Ellipse/Trace Method of Percent Area Reduction Calculation (% Area Red)

To perform an Ellipse/Trace Method % area reduction:

1. With a 2D frozen image press MEASURE button located above the trackball.
2. A caliper will appear on the LCD display.
3. If the Basic measurement tab is not active on the touch screen, tap Basic on the touch
screen to activate it.
4. Tap % Area Red on the touch screen.
5. Turn the touch screen dial directly below % Area Red and select “Ellipse/Trace”.
6. Use the trackball to position the first caliper of the outer ellipse.
7. Press SELECT to set the caliper position and activate the second caliper of the outer
ellipse.
8. Use the trackball to position the second caliper.
9. Press SELECT to set the second caliper position and activate the outer ellipse sides.
10. Use the trackball to increase/decrease the sides of the outer ellipse.
Note: Press UPDATE to toggle control of the calipers/ellipse prior to completion of
ellipse measurement.

11. Press SELECT to complete the outer ellipse measurement.

12. Use the trackball to position the second caliper at the start position of the inner trace
measurement.
13. Press SELECT to set the second caliper.
14. Use the trackball to trace the circumference the area of interest.
15. Press SELECT to set the second caliper position.
16. The resulting % Area Reduction appears on the bottom right of the LCD display along
with the inner and outer measurements that were used in the calculation.

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 7.0.5.3 Trace/Trace Method of Percent Area Reduction Calculation (% Area Red)

To perform a Trace/Trace Method % area reduction:

1. With a 2D frozen image press MEASURE button located above the trackball.
2. A caliper will appear on the LCD display.
3. If the Basic measurement tab is not active on the touch screen, tap Basic on the touch
screen to activate it.
4. Tap % Area Red on the touch screen.
5. Turn the touch screen dial directly below % Area Red to select “Trace/Trace”.
6. Use the trackball to position the first caliper at the start position.
7. Press SELECT to set the first caliper.
8. Use the trackball to trace the circumference the area of interest.
Note: Use the keyboard BSP key to delete the previous trace move/position. Press
BSP several times to undo several previous positions.

9. Press SELECT to set the trace.

10. Use the trackball to position the second caliper at the start position.
11. Press SELECT to set the second caliper.
12. Use the trackball to trace the circumference the area of interest.
13. Press SELECT to set the second caliper position.
14. The resulting % Area Reduction appears on the bottom right of the LCD display along
with the inner and outer measurements that were used in the calculation.

7.0.5.4 Trace/Ellipse Method of Percent Area Reduction Calculation (% Area Red)

To perform a Trace/Ellipse Method % area reduction:

1. With a 2D frozen image press MEASURE button located above the trackball.
2. A caliper will appear on the LCD display.
3. If the Basic measurement tab is not active on the touch screen, tap Basic on the touch
screen to activate it.
4. Tap % Area Red on the touch screen.
5. Turn the touch screen dial directly below % Area Red to select “Trace/Ellipse”.
6. Use the trackball to position the first caliper at the start position.
7. Press SELECT to set the first caliper.
8. Use the trackball to trace the circumference the area of interest.
Note: Use the keyboard BSP key to delete the previous trace move/position. Press
BSP several times to undo several previous positions.

9. Press SELECT to set the trace.

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 10. Use the trackball to position the first caliper of the inner ellipse.
11. Press SELECT to set the caliper position and activate the second caliper of the inner
ellipse.
12. Use the trackball to position the second caliper.
13. Press SELECT to set the second caliper position and activate the inner ellipse sides.
14. Use the trackball to increase/decrease the sides of the inner ellipse.
Note: Press UPDATE to toggle control of the calipers/ellipse prior to completion of
ellipse measurement.

15. Press SELECT to complete the inner ellipse measurement.

16. The resulting % Area Reduction appears on the bottom right of the LCD display along
with the inner and outer measurements that were used in the calculation.

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7.1 M-MODE BASIC MEASUREMENTS

7.1.1 M-Mode Heart Rate Measurement

To perform an M-mode heart rate measurement:

1. With a frozen M-mode image press MEASURE located above the trackball.
2. A measurements tab appears on the touch screen. By default the HR caliper cursor
appears on the M-Mode sweep.
Note: The default measurements shown are preset by clinical application and imaging
mode. To access measurements specific to a clinical application tap Select App
on the touch screen to select an alternate clinical application.

3. Use the trackball to position the caliper cursor on the M-Mode sweep to the first beat.
4. Press SELECT to set the first cursor and activate a second caliper cursor.
5. Use the trackball to position the second caliper cursor to the next beat.
Note: The default heart rate measurement requires one heart beat. Refer to section
9.0.6 Measurements to change the # of beats required for the HR calculation.

6. To reposition either cursor press UPDATE to toggle control between the two cursors.
7. Press SELECT to set the measurement. The heart rate value appears on the bottom
right of the LCD display.

7.1.2 M-Mode Slope Measurement (Time, Slope and Distance)

Note: The M-mode Slope measurement includes Time, Slope and Distance.

To perform an M-mode slope measurement:

1. With a frozen M-mode image press MEASURE located above the trackball.
2. A measurements tab appears on the touch screen. A caliper cursor appears on the M-
Mode sweep.
3. Tap Slope on the touch screen.
4. Use the trackball to position the first caliper cursor on the M-Mode sweep.
5. Press SELECT to set the first cursor and activate a second caliper cursor.
6. Use the trackball to position the second caliper cursor to the desired location.
7. Press SELECT to set the measurement. The time, distance and slope values appear
on the bottom right of the LCD display.

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7.2 PW DOPPLER BASIC MEASUREMENTS

When several methods of performing a measurement are available tap, the selected measurement
on the touch screen and turn the touch screen dial beneath the selection to choose the preferred
method. The method selected appears in a message bubble on the lower right corner of the
monitor (i.e., Continual Manual Doppler Trace versus Point by Point Manual Doppler Trace

7.2.1 Velocity Measurement(s)

Note: Refer to section 9.0.6 Measurements to configure the Display Options for
Velocity. There are six (6) available Velocity display values: PSV, EDV, PSVPG,
EDVPG, RI, SD.

To perform a velocity measurement:

1. With a frozen Doppler trace press MEASURE located above the trackball.
2. A measurements tab appears on the touch screen. By default the Velocity caliper
appears on the Doppler trace.
Note: The default measurements shown are preset by clinical application and imaging
mode. To access measurements specific to a clinical application tap Select App
on the touch screen to select an alternate clinical application.

3. Use the trackball to position the caliper to the peak velocity. A velocity (PSV) value
appears on the LCD display.

4. Press SELECT to set the first velocity caliper and begin a second velocity
measurement.
5. Use the trackball to position the second caliper.
6. An end velocity (EDV) value with associated RI and SD ratios appear on the LCD
display.

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 7.2.2 Doppler Manual Trace Measurement

Note: Refer to section 9.0.6 Measurements to configure the Doppler trace display values.
There are 11 available Doppler trace display values: PSV, EDV, AVp, AVm, AT, DT,
VTI, PGr, RI, PI, SD

7.2.2.1 Doppler Manual Trace Measurement – Continual Method

To perform a manual Doppler trace, using the Continual method:

Note: To ensure the most accurate results, position the first caliper at the start of the
waveform and set the last caliper at end diastole for manual Doppler traces.

1. With a frozen Doppler trace select MEASURE located above the trackball.
2. A measurements tab appears on the touch screen. By default the Velocity caliper
appears on the Doppler trace.
3. Tap D-Trace on the touch screen to assign the caliper to D-Trace.
4. Turn the touch screen dial directly below D-trace to select “SONIX – Calcs Trace set
to Continual Trace.”
Note: The selected method will appear in a message bubble on the lower right portion
of the LCD display.

5. Use the trackball to position the first caliper at the start of the desired Doppler
waveform.
6. Press SELECT to set the start position.
7. Use the trackball to draw the trace along the desired waveform right up to the point of
end diastole.
8. Press SELECT to end and set the trace.
Note: Use the BSP (Backspace) key on the keyboard to correct an incorrect move on
a trace measurement.

9. The trace values will appear on the LCD display.

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 7.2.2.2 Doppler Manual Trace Measurement - Point by Point Method

To perform a manual Doppler trace, using the Point by Point method:

Note: To ensure the most accurate results, position the first caliper at the start of the
waveform and set the last caliper at end diastole for manual Doppler traces.

1. With a frozen Doppler trace select MEASURE located above the trackball.
2. A measurements tab appears on the touch screen. By default the Velocity caliper
appears on the Doppler trace.
3. Tap D-Trace on the touch screen to assign the caliper to D-Trace.
4. Turn the touch screen dial directly below D-trace to select “SONIX – Calcs Trace set
to Point by Point.”
Note: The selected method will appear in a message bubble on the lower right portion
of the LCD display.

5. Use the trackball to position the first caliper at the start of the desired Doppler
waveform.
6. Press SELECT to set the start position.
Note: Use the BSP (Backspace) key on the keyboard to correct an incorrect move on
a trace measurement.

7. Use the trackball to position the next trace position along the Doppler trace.
8. Press UPDATE to set the next caliper position.
9. Continue until the point of end diastole.
10. Press SELECT to end and set the trace.
11. The trace values will appear on the LCD display.

7.2.3 Doppler Auto Trace Measurement (D-Range)

To perform an auto Doppler trace (D-Range):

1. With a frozen Doppler trace select MEASURE located above the trackball.
2. A measurements tab appears on the touch screen. By default the Velocity caliper
appears on the Doppler trace. Tap D-Range on the touch screen to assign the caliper
to D-Range.
3. Use the trackball to position the first caliper. Press SELECT to set it.
4. The second caliper appears on the screen. Use the trackball to position it. Press
SELECT to set the D-Range.
5. The trace values appear on the screen.

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 7.2.4 Doppler Heart Rate Measurement

To perform a Doppler Heart Rate:

1. With a frozen Doppler trace select MEASURE located above the trackball.
2. A measurements tab appears on the touch screen. By default the Velocity caliper
appears on the Doppler trace. Tap HR on the touch screen.
3. Use the trackball to position the caliper on the Doppler trace to the first beat.
Note: The default heart rate measurement requires one heart beat. Refer to section
9.0.6 Measurements in System Setup to change the # of beats required for the
HR calculation.
4. Press SELECT to set the first caliper and activate a second caliper. Use the trackball to
position the second caliper to the desired next beat.
5. Press SELECT to set the measurement. The heart rate value appears on the screen.

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7.3 APPLICATION-SPECIFIC MEASUREMENT/CALCULATION
Warning: Various factors may affect the accuracy of Obstetrical measurements. Ensure the
system date/time is configured correctly. Ensure the desired Obstetrical calculation
author has been selected for each parameter. Ensure the saved Obstetrical
measurement data from the previous exam has been deleted prior to saving new
Obstetrical measurement data. Ensure correct fetus (A, B or C) is selected on the
Measurements touch screen prior to performing obstetrical measurements. Fetal labels
are not displayed with the measurement on the image field. Ultrasonix recommends
that the user annotate the image as required to differentiate the measurements.

Notes:
• For twins and triplets obstetrical (OB) measurements, ensure fetus # is “2” or “3” on the Patient
Management (ID) data entry page.
• Selection of OB Doppler measurements MCA (middle cerebral artery) and Umb A (umbilical
artery) enable a 2 velocity measurement to be made which displays PSV, EDV, RI and S/D
ratio results. To obtain a PI (Pulsatility Index) measurement for MCA or Umb A, select MCA –
PI or Umb A – PI to enable a Doppler trace measurement which displays PSV, EDV, RI, S/D
and PI results.
• An asterisk (*) beside the parameter label on the touch screen implies a measurement has
been previously saved to report.

To assign an application-specific label to a measurement:

1. With a frozen 2D, M-mode or Doppler image press the MEASURE button located
above the trackball.
2. A measurements tab appears on the touch screen. A default caliper appears on the
image.
3. The default measurements shown are preset by clinical application and imaging mode.
To access measurements specific to a clinical application tap Select App on the touch
screen to select an alternate clinical application.
4. Tap the desired label from the touch screen menu. Use the trackball to position the first
caliper.
5. Press SELECT to activate the second caliper. Use the trackball to position the caliper.
Note: For additional details on performing a particular type of measurement (i.e., HC
requires a Circumference - trace or ellipse, refer to sections 7.0, 7.1 and 7.2
under Basic Measurements).
6. To reposition either caliper press UPDATE to toggle control between the two calipers.
7. Press SELECT to set the measurement. The measurement value appears on the
image screen. The measurement is stored to the application specific report page.
8. To delete the measurement either unfreeze the image or press DEL to the left of the
MEASURE button. Press the MEASURE button to remove all the measurements from
the frozen image screen.
Note: For additional details on performing a particular type of measurement (i.e., HC
requires a Circumference - trace or ellipse, refer to sections 7.0, 7.1 and 7.2
under Basic Measurements).

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 Sample Application-Specific Measurement

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7.4 REPORTS/CLINICAL ANALYSIS

7.4.1 Reports for all Applications

Reports are not saved to the patient file. In order to access them after an exam has ended,
individual pages must either be printed or stored (refer to 9.1.7 Print Keys for setup details
on the PRINT 1, PRINT 2 and PRINT 3/ARCHIVE console buttons).
All reports have the following functionality in common:
• controls are available using the touch screen/dials and on Report pages via the console
• Comment section where extra data may be entered using the keyboard (maximum of
10 lines).

To access the report pages for the active patient/exam:

1. During an exam, after taking at least one measurement (and while the console
MEASURE button is still active), tap Report on the touch screen.
Note: The Report type and its associated measurements are dependent upon the
Preset chosen for the exam.

2. For OB Reports, use the trackball and SELECT button to page through the Report.
3. To exit the Report, select the Close button on the LCD display or tap Report on the
touch screen.
Note: In order to access an individual report page after an exam has ended, it must
either be printed or stored (refer to 9.1.7 Print Keys for setup details on the
PRINT 1, PRINT 2 and PRINT 3/ARCHIVE console buttons).

7.4.2 Obstetrics Report

An OB Report includes several items that are not available with other report types:
• page number total recorded at bottom of each page, e.g., “Page 1 of 1” or “Page 3 of 6”
• only OB reports include graphs
• only an OB report can have specific measurements deleted.

To delete obstetrical biometry measurements from report:

1. With a frozen image, select MEASURE located above the trackball.
2. A measurements tab appears on the touch screen. If the default tab is not OB
biometry, choose the OB application using Select App on the touch screen.
3. Tap the biometry label (e.g., BPD) of the measurement to be deleted.
Note: Biometric labels with associated measurements are marked with an asterisk (*).

4. Tap History on the bottom of the touch screen.

5. A list of the selected biometry’s three (3) most recently saved measurements will
appear on the touch screen.
6. Tap the measurement to be deleted.

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 7. Tap Delete and the measurement will be removed from the OB report pages.

Caution: In the case of twins or triplets, ensure the correct fetus is selected prior to
deleting the OB parameter measurement.

8. Tap Back on the touch screen to return to OB Biometry.

Sample Obstetrical Report

As with this Print

button, anything that
is “grayed” out is not
available for use.

Page numbering Available only

Use these buttons to move directly to specific pages
for OB Reports.
of the OB Report. The buttons will vary by Report
page (i.e., the Graphs selection will not be available
on the actual Graphs page of this Report.

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 Each item on the Obstetrics
Report Anatomy Checklist
page has a small, editable
comment field.

Use Select/Clear All to

select/deselect all items in
the Anatomy Checklist at
the same time.

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 Multi-line, editable Comment
field (available with all reports). Each graph is labeled in
Enter data using the keyboard. Percentile (as this one is)
or Standard Deviation
(e.g., ± 2SD)

Note: Graphs are only available on the Obstetrics Report.

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CHAPTER 8 - TEXT, ANNOTATIONS and PICTOGRAMS

Text, annotation and pictograms enable the user to label the image prior to image transfer and storage.

8.0 TEXT AND ANNOTATIONS

The SONIX system enables the user to add text (via the keyboard) or preset annotations (listed on
the touch screen) to the image field. Annotations are factory preset by clinical application. Users
may customize the annotations. Refer to section 9.0.2 Imaging Presets - Annotations to
customize the SONIX annotation packages. An auto-complete text feature is available that
anticipates the word being entered (section 9.0.5 Annotations). An annotation arrow is available.

8.0.1 Keyboard Text

To enter keyboard text:

1. Press the TEXT button on the console (to the right of the keyboard) to activate the
text/annotation mode.
2. A text cursor appears on the image screen.
3. Use the trackball to position the text cursor as required.
4. Use the keyboard to enter the desired text or tap the required Annotation on the touch
screen.
Note: When the Auto Complete function is active (9.0.5 Annotations), enter the first
letter(s) of the preset word and the rest of the word will be presented in blue. If
more than one preset word with the same first letter exists, then use the Tab key
to cycle through all the preset words with that letter. To set the selected preset
word, press Enter on the keyboard.

5. Use the trackball to relocate the text cursor as required.

6. Use the keyboard back space arrow to remove the letter(s) to the left of the text cursor.
7. Press the TEXT button to exit text/annotation mode.

8.0.2 Set Text Home Position

To set the text home position:

1. Press the TEXT button on the console (to the right of the keyboard) to activate the
text/annotation mode.
2. Use the trackball to position cursor in the desired Home location.
3. Tap Set Home on the touch screen to set the home position.
Note: Tap the Home Position button on the touch screen to automatically reposition
the cursor to the previously-defined Text Home position.

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 8.0.3 Application-Specific Annotations

To enter application specific annotations:

1. Press the TEXT button on the console (to the right of the keyboard) to activate the
text/annotation mode.
2. Once the text/annotation cursor location is presented on the screen, use the trackball
to reposition the cursor as required.
3. Tap the desired annotation from the selection presented on the touch screen.

Note: To modify the preset Annotations, refer to section 9.0.2 Imaging Presets -
Annotations.

4. Repeat Step 2 and 3 as many times as required.

5. Press the TEXT button to exit text/annotations mode.

8.0.4 Deleting Text/Annotation

To delete all text/annotations:

1. Press the TEXT button on the console (to the right of the keyboard) to activate the
text/annotation mode.
2. Press the console DEL button (below the TEXT button on the console) to delete all
user entered text/annotation from the image field.

Note: Alternatively, move the cursor to the desired position and use the keyboard back
space arrow to remove the letter(s) to the left of the text cursor.
To remove the most recently entered annotation, select Delete Last from the
touch screen while in Text mode. Repeating this action will delete each
subsequent entry in reverse order.

3. Press the TEXT button to exit annotation mode.

8.0.5 Text Arrow

To enter the text arrow:

1. Press the console ARROW button (above and to the left of the keyboard).

2. When the arrow appears on the image screen, use the trackball to position/rotate it.
3. Press the console ARROW button to remove the text arrow.

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8.1 PICTOGRAMS

Pictograms are preset, application-specific icons that enable the user to visually label the imaging
location. Customizing specific Pictograms within Presets is controlled through 9.0.3 Imaging
Presets – Pictograms.

To activate an application specific pictogram:

1. Press the PICTOGRAM button on the console (above and to the left of the keyboard).

2. Rotate the knob below the Pictogram heading on the touch screen to move through
the various pictograms available.
3. Once the desired Pictogram is located, press the console PICTOGRAM button again.

4. Press the console SELECT button and then use the trackball to position the Pictogram
orientation marker to the desired location on the pictogram.
5. To rotate the Pictogram orientation marker, tap Rotate on the touch screen and turn
the knob until the desired position is reached.
6. Once positioned as required, press SELECT again.
7. To re-access the pictogram functions after performing other imaging functions, press
the Pictogram button again and repeat Steps 2 to 6.
8. To hide the Pictogram from view, tap the Hide button on the touch screen.

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CHAPTER 9 - SYSTEM SETUP

The various features and setting of the SONIX ultrasound system can be customized via one of the three
(3) System Setup menus: User, Administrator and Service. Because the menu structure is hierarchical,
Admin settings are accessed via the Users Settings menu and Service settings are accessed via the
Admin Settings menu.

Password protection can be applied as follows:

• Users Settings: no password protection

• Admin Settings: optional password protection
• Service Settings: always password protected. Only qualified Ultrasonix Medical Corporation service
personnel can access this menu.

The following table provides a quick overview of the system’s setup menus. Refer to the specific sections
later in this chapter for further details on any particular setup page.

MENU (operator console button)

USER SETTINGS Software version is displayed across the bottom of the menu.

Presets View and manage imaging presets.

Toggle on/off the three (3) available global Annotation Settings: Auto
Complete, Capitalize All Annotations and Clear On Unfreeze.
Annotations
Note: Customization of Preset-specific Annotations is handled through
the Preset menu. Be sure the Annotations tab is selected.

Configure graphic settings, including: connection points, text and caliper

sizes as well as colors for connection points and calipers.
Use OB Settings to configure fetal age, growth and weight calculations
Measurements based on a variety of authors, such as Hadlock – or create custom age
and growth tables.
Set Pregnancy Weeks, Heart Rate Beats and Volume Units.
Select Display Options for Area, Velocity and Doppler traces.

Set default configuration for freehand 3D image acquisition – Parallel

3D
(cm) or Fan (degrees). Set display timing for 3D Config dialog box.

Select display size - High Res (Image screen with saved image
Display thumbnails) or Full Screen (no thumbnails).
Adjust screen brightness and touch screen brightness/contrast.

Admin… Access the Admin Settings menu.

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 Using the System menu, users have the option to globally password
ADMIN SETTINGS
protect all Admin Settings.

Customize the Institution Name.

Set defaults for: Interface Language, Internal Settings (regional and
language settings) and Date/Time.
Set default imaging mode entry point and screen layouts for M-Mode and
Doppler.
System
Select system shutdown options: Confirm Shutdown and Enable Fast
Boot.)
Import or export user-defined data (OB tables, DICOM settings, etc.).
Reset system to Factory Defaults.
Set a single, Administrative password.

Software Updates Update system software via the Internet, CD or a USB connection.

Licensing View and add license details.

DICOM Enable and configure DICOM Storage, Print and Worklist.

Configure peripherals: Paper Printer, Monitor, VCR/Photo, Footswitch

Peripherals
and (Image) Brightness/Contrast.

Customize the entry of Patient information using a variety of options,

Patient including: show/hide fields, create new fields, allow/disallow editing of
specific fields, select gender and application defaults.

Set the Store, Print, Archive access parameters for the three (3) Print
Print Keys
Keys located on the operator console.

Configure the capture settings for still images, video output and cine loop
Capture
storage.

Configure settings for connecting to the: network (LAN or dialup),

Network
TCP/IP, e-mail and online support.

Service… Access the Service Settings menu .

The SONIX system is delivered with this setting under Password

protection.
SERVICE SETTINGS
Note: Only qualified Ultrasonix Medical Corporation service personnel
can access this menu.

Use the trackball and SELECT button to Close each menu and exit the menu system. To exit the entire
menu system in one step, press the MENU button.
Note: Be sure to save whatever edits are in progress before pressing the Menu button to exit, otherwise
those changes will be lost.

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 To access the System Setup menus:
1. Press the MENU button located on the left side of the operator console.
2. The User Settings menu will be presented.

Software Version Number

9.0 USER SETTINGS

9.0.1 Imaging Presets

Presets Setup enables users to manage factory default and user-defined imaging presets.
Note: Refer to 3.5.2 User-Defined Presets to create 2D user-defined Presets.
3D/4D user-defined Presets are handled in a different manner. Please refer to 9.0.4
Imaging Presets – 3D/4D for more details.

Preset
Checkbox

Rename
and
Delete

Note: Rename and Delete are only available if user-defined Presets have been created.

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 To access the Presets Setup page:
1. Press the MENU button located on the left side of the operator console.
2. From the User Settings menu, select Presets.

Default settings are locked (as indicated by the lock icon adjacent to the Preset name). The
only user-definable aspects of the default settings are available through the Annotations,
Pictograms and 3D/4D tabs on the right hand of the page and through Annotations on the
User Settings menu.
User-defined Presets are marked with a key icon. These cannot be locked.
The menu displayed on the left hand side of the page contains all existing Presets, both
default and custom. Each clinical application is delivered with at least one default Preset.
Note: The list of Presets is transducer dependent. Ensure that the desired transducer is
connected in order to view its associated Presets.

9.0.1.1 Show/Hide Imaging Presets:

Preset availability can be controlled using the Preset checkbox. When selected, as
indicated by the presence of the green check mark, the Preset will be visible on the touch
screen during an exam (providing the applicable transducer is connected). When de-
selected, the Presets will not be visible on the touch screen, and therefore unable to be
selected for use during an exam.
Note: This show/hide function applies to both default and user-defined Presets.

To show/hide an Imaging Preset on the touch screen

1. Press the MENU button located on the left side of the operator console.
2. From the User Settings menu, select Presets.
3. Using the trackball, position the cursor over the relevant Preset checkbox and press
SELECT.

4. Select OK to accept the changes or Cancel to exit without saving.

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 9.0.1.2 Rename User-Defined Imaging Preset:
Note: Refer to 3.5.2 User-Defined Presets to create 2D user-defined Presets.

To rename a previously created user-defined Preset:

1. Press the MENU button located on the left side of the operator console.
2. From the User Settings menu, select Presets.
3. Using the trackball, position the cursor over the user-defined Preset to be renamed and
press SELECT.
4. Select Rename (located near the bottom left onscreen menu).
5. Type a new, unique name in the Rename Preset message box.

6. Select OK to accept the changes or Cancel to exit without saving.

9.0.1.3 Delete User-defined Imaging Preset:

To delete a user-defined imaging preset:

1. Press the MENU button located on the left side of the operator console.
2. From the User Settings menu, select Presets.
3. Using the trackball, position the cursor over the user-defined Preset to be deleted and
press SELECT.
4. Select Delete from the bottom left onscreen menu.
5. Select Yes to confirm the deletion or No to cancel the operation.

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 9.0.2 Imaging Presets – Annotations

Note: Refer to 9.0.5 Annotations for details on Global Annotation Settings.

The ability to manipulate specific Annotations attached to both user-defined and default
Presets is handled through the Annotations tab on the Presets Setup page. Annotation
text appears by clinical application on the console touch screen.

Annotations Tab

Page Selection

New Page

Delete Page

Restore Defaults

Note: The order in which Annotations appear here is matched on the touch screen during
text entry (8.0 Text and Annotations).

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 9.0.2.1 Modify Annotations:

Changes can only be made to the Annotations of one Preset at a time.

To modify a Preset’s Annotations:

1. Press the MENU button located on the left side of the operator console.
2. From the User Settings menu, select Presets.
3. The Presets Setups page will be presented with the Annotations tab selected.
4. With the trackball and SELECT button, highlight the relevant Preset from the menu on
the left hand side of the screen.
5. With the trackball and SELECT button, highlight the relevant Annotation on the right
hand side of the screen.
6. Use the keyboard to type in the new Annotation.
7. If the desired Preset has multiple pages of Annotations, use the trackball to move the
cursor to the onscreen Page Selection button, then hit the console SELECT button.
8. Repeat this operation to move through additional pages of Annotations, repeating steps
5 and 6 (above), as necessary.

9.0.2.2 Set Text/Annotation Cursor Home Position

Once a text/Annotation cursor home position has been selected, it will remain as it was set
until another position is selected.

To set the text/Annotation cursor home position:

1. When in imaging mode, press the console TEXT button located to the left of the
trackball.
2. Use the trackball to move the cursor wherever the home cursor position should be.
3. On the Annotations touch screen, tap Set Home.
4. To locate the home position whenever the TEXT button is selected, tap Home
Position on the touch screen and the cursor will be reoriented to the appropriate place.

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 9.0.3 Imaging Presets – Pictograms

The ability to attach/detach specific Pictograms to both user-defined and default Presets is
handled via the Pictograms tab in Presets Setup. Re-ordering the sequence in which they
will appear on the touch screen during a scanning session is handled here as well.

Pictogram
Selectors

Pictograms
Tab

Default or
Selected Pictogram Order Pictogram
Selections

Restore Defaults
List of Pictograms
List of attached to selected Preset
Available
Pictograms

9.0.3.1 Modify the Pictogram Selections Attached to Imaging Presets:

To Add Pictograms to an Imaging Preset:

1. Press the MENU button located on the left side of the operator console.
2. From the User Settings menu, select Presets.
3. The Presets Setups page will be presented with the Annotations tab selected. Click
on the Pictograms tab.
4. With the trackball and SELECT button, highlight the relevant Preset in the left hand
column on the screen.
5. Highlight the relevant Pictogram in the list of available Pictograms in the center of the
screen.
6. Once a Pictogram has been highlighted, use the right facing selector button to move it
to the list of selected Pictograms.
7. Repeat Steps 5 and 6 as many times as required.

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 To Delete Pictograms from an Imaging Preset:
1. Press the MENU button located on the left side of the operator console.
2. From the User Settings menu, select Presets.
3. The Presets Setups page will be presented with the Annotations tab selected. Click
on the Pictograms tab.
4. With the trackball and SELECT button, highlight the relevant Preset in the left hand
column on the screen.
5. Highlight the relevant Pictogram in the list of selected Pictograms on the right hand
side of the screen.
6. Once the Pictogram has been highlighted, use the left facing selector button to delete it
from the list of selected Pictograms.
7. Repeat Steps 5 and 6 as many times as required.

To Reorder Selected Pictograms Attached to an Imaging Preset:

1. Press the MENU button located on the left side of the operator console.
2. From the User Settings menu, select Presets.
3. The Presets Setups page will be presented with the Annotations tab selected. Click
on the Pictograms tab.
4. With the trackball and SELECT button, highlight the relevant Preset in the left hand
column on the screen.
5. Highlight the relevant Pictogram in the list of selected Pictograms on the right hand
side of the screen.
6. Once the Pictogram has been highlighted, use the up or down arrow button (on the
right hand side of the screen) to move it another place in the list of selected
Pictograms.
7. Repeat Steps 5 and 6 as many times as required.

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 9.0.4 Imaging Presets – 3D/4D

The ability to attach/detach specific 3D/4D Presets to both user-defined and default Presets
is handled via the 3D/4D tab in Presets Setup.
Default settings are locked (as indicated by the lock icon adjacent to the 3D/4D Preset
name) and cannot be edited.
User-defined Presets are marked with a key icon. These cannot be locked and can be
renamed or deleted through 9.0.7 3D Settings.
During imaging, a user-defined Preset name is shown on the LCD display in square
brackets (e.g., [User-Defined Preset]). On the touch screen, user-defined presets are
presented in italics (e.g., User-Defined Preset).
To create a user-defined, 3D/4D Preset, refer to 6.0.10 User-Defined Presets for 3D/4D.

3D/4D Tab
Assigned 3D Preset

Restore Defaults

To View the 3D/4D Imaging Selection Attached to Imaging Presets:

1. Press the console MENU button.
2. From the User Settings menu, select Presets.
3. The Presets Setups page will be presented with the Annotations tab selected. Click
on the 3D/4D tab.
Note: If a 4D transducer is not connected to the SONIX, then the 4D Imaging Presets
normally available will not be present in the left hand column on the LCD display.

4. With the trackball and SELECT button, view the Presets listed in the drop menu box.

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 9.0.5 Annotations

There are three (3) Global Annotation settings available:

When selected, this feature automatically fills in a word

when the first letter(s) is entered on the monitor.
If more than one Preset begins with the same letter, use the
Auto Complete tab key to move through the list or continue typing the
Preset name. When enough of the name has been
completed in order to jump to the correct entry, the desired
Preset name will appear on the monitor and can be
selected.

When selected, this feature will automatically type an upper

Capitalize All Annotations
case letter for each word in the Annotation.

When selected, this feature will automatically clear the

Annotations from the image field with unfreeze. If this option
Clear On Unfreeze
has not been selected, the text will remain on the image
field until the user deletes it.

To access the global Annotations settings page:

1. Press the MENU button located on the left side of the operator console.
2. From the User Settings menu, select Annotations.

Note: Please refer to 9.0.2 Imaging Preset – Annotations for details on configuring
Preset-specific Annotations.

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 9.0.6 Measurements

The Measurements menu enables users to configure the measurement/calculation

packages.
Measurements are available on the touch screen by clinical application with the selection of
the MEASURE button.

Warning: Ultrasonix does not endorse user-defined measurements for diagnostic purposes.
All user-defined measurements are used at the operator’s discretion and risk only.

To access the Measurements configuration menu:

1. Press the MENU button located on the left side of the operator console.
2. From the User Settings menu, select Measurements.

9.0.6.1 Modify Caliper/Caliper-Text Graphics:

The following items are available to customize the appearance of the graphics for the
caliper, caliper label and measurement values displayed on the image field:

Show Connection When selected, this feature displays the connection points (dotted
Points line) between the linear calipers.
Allows the selection of one of four measurement label font size
Display Text
options: Small, Regular, Medium and Large.
Allows the selection of one of four caliper size options: Small,
Caliper Size
Regular, Medium and Large.

Connection Point Allows the selection of the color of the caliper connection points
Color (dots) between the linear calipers. The default is turquoise.

Allows the selection of the color of the caliper end points. The
Caliper Color
default is turquoise.

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 Caution: Some caliper sizes/colors, font sizes or dot colors may not appear clearly on the
image screen, stored image or printed/recorded image. To ensure clear
visualization of the caliper, label font and connection points, Ultrasonix
recommends setting the caliper graphics to at least Regular or Medium size.

Note: To ensure the caliper modifications have been activated, switch imaging modes after
exiting the Setup menus.

9.0.6.2 Display Options for measurement/calculation values:

AR Area
CIR Circumference
Area
SA Short Axis
LA Long Axis
PSV Peak Systolic Velocity
EDV End Diastolic Velocity
PSVPG Peak Systolic Velocity Pressure Gradient
Velocity
EDVPG End Diastolic Velocity Pressure Gradient
RI Resistive Index
SD Systolic/Diastolic Ratio
PSV Peak Systolic Velocity
EDV End Diastolic Velocity
AVp Peak Average Velocity
AVm Mean Average Velocity
AT Acceleration Time
Doppler Trace DT Deceleration Time
VTI Velocity Time Integral
PGr Pressure Gradient
RI Resistive Index
PI Pulsatility Index
SD Systolic/Diastolic Ratio
PV Peak Velocity
PGr Pressure Gradient
Doppler Trace (Cardiac) VTI Velocity Time Integral
MV Mean Velocity
MGr Mean Pressure Gradient

To set each of the measurement display options:

1. From Display Options, select a measurement type from the first drop down menu:
Area, Velocity, Doppler Trace or Doppler Trace (Cardiac).
2. Select the desired measurements/calculations from the second drop down menu to
display with the measurement type.
3. Select OK to save the changes and exit the setup page.

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 9.0.6.3 Additional Measurement Settings (Pregnancy Weeks, Heart Beats, etc.):

Defines the number of weeks used to calculate the EDD (Estimated

Pregnancy Weeks Delivery Date) based on LMP (Last Menstrual Period). Range: 35 –
45 weeks.
Number of beats used to measure the heart rate (HR and FHR) on
Heart Rate Beats
an M-mode and Doppler trace. Range: 1 – 7 beats.
Volume Units Type of unit used to display Volume calculation: ml or cc.

9.0.6.4 Obstetrical Settings:

Note: Factory preset obstetrical tables can not be modified or deleted.

The following OB parameters are available on the SONIX system:

Parameter Authors
Hadlock
Hansmann
AC
Lessoway
Tokyo
APTD Tokyo (No age table – used for EFW only)

Hadlock
Hansmann
BPD Lessoway
Osaka
Tokyo
CEREB Hill

Hadlock
Fetal Age Hansmann
CRL Lessoway
Osaka
Rempen
Hadlock
Hansmann
Lessoway
FL
Merz
Osaka
Tokyo
FTA Osaka

Hansmann
GS Nyberg
Rempen

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 Parameter Authors
Hadlock
HC Hansmann
Lessoway
HL Jeanty

Fetal Age cont’d OFD Hansmann

TL Jeanty
Hansmann
TTD
Tokyo (No age table – used for EFW only)
UL Jeanty
Hadlock (AC/BPD/FL/HC)
(AC/FL/HC)
(AC/BPD/FL)
Estimated (AC/FL)
EFW
Fetal Weight Hansmann
Shepard
Tokyo
Osaka
Hadlock
AC Lessoway
Tokyo
AFI Moore
Hadlock
Lessoway
BPD
Osaka
Tokyo
Doubilet
BW% Hadlock
Osaka
Fetal Growth Hadlock
CRL Lessoway
Osaka
Hadlock
Jeanty
FL Lessoway
Osaka
Tokyo
FTA Osaka
Hadlock
HC
Lessoway
HL Jeanty

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 Parameter Authors
CI (HC) Hadlock
FL/AC Hadlock
Ratios FL/BPD Hohler
FL/HC Hadlock
HC/AC Campbell

Warning: Ultrasonix does not endorse user-defined measurements, calculations and

tables for diagnostic purposes. All user-defined measurements, calculations and
tables are used at the operator’s discretion and risk only.

To set the Obstetrical Calculation Authors:

1. Press the MENU button located on the left side of the operator console.
2. From the User Settings menu, select Measurements.
3. Select OB Settings from the top right corner of the Measurements page.

4. Select the Fetal Age parameter, Fetal Growth parameter or Estimated Fetal Weight
authors from the drop down menus.
5. Select OK to save the changes and exit or Cancel to exit without saving changes.

Warning: Various factors may affect the accuracy of Obstetrical measurements. Ensure the
system date and time are configured correctly. Ensure the desired Obstetrical
calculation author has been selected for each parameter. Ensure the saved
Obstetrical measurement data from the previous exam has been deleted prior to
saving new patient LMP, etc. data and measurement data.

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 To create new Obstetrical Calculation Authors and Look-up Tables:
1. Press the MENU button located on the left side of the operator console.
2. From the User Settings menu, select Measurements.
3. Select OB Settings from the top right corner of the Measurements page.
4. Select the Tables button from the bottom right of the OB Settings page.
5. The OB Table Editor page will be presented.

6. Select Create Author from the menu on the right hand side of the page.
7. Enter a new Table Author and select Create to save the name to the author list.

8. Highlight the newly created author from the list and select the Create Table button.

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 Note: Default Tables are locked (as indicated by the lock icon adjacent to the Table
name) and cannot be edited/deleted. User-created tables are marked with a key
icon and can be edited/deleted.

9. From the drop down, Based on menu, select the desired parameter (BPD, HC, etc.).

10. Select the desired table Range Representation: Percentile, Standard Deviation, None.
11. Select the desired Table Type: Age Table, Growth Table.
12. From the drop down Measurement menu, select the desired unit: blank, %, cm, mm.
Note: The “blank” setting is useful when dealing with ratios.

Note: AC and HC are assumed to be circumference measurements.

13. From the drop down Gestational Age menu, select the desired unit: days, weeks.
14. Select Save to complete the changes and return to the OB Table Editor or Cancel to
exit without saving changes.

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 To enter data into a new OB table:
1. Select the newly created Table (listed under the user-defined author) the Table list.
The right hand section of the screen will show the columns for the table parameters as
previously defined.

Note: In this example, the Table was configured Based on “AC”, with the Range
Representation defined as “None”, Table Type as “Age Table” and Units
“Measurement = “mm”.

2. Use the keyboard, trackball and tab key as required to enter the table data. Insert Row
and Delete Row buttons are available to make this process easier.
Warning: Enter Gestational Age values in “days” or “weeks+days”

(e.g., 86 or 12+2, 84 or 12+0)

The system assumes all entries are in days unless the “+” sign is entered.

3. Select the Save & Exit button on the left hand side of the screen to save any newly
entered/edited data and exit the page, Save to save any newly entered/edited data but
remain in the OB Table Editor or Exit to cancel any newly entered/edited data and exit
the page.

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 9.0.7 3D Settings

3D Settings enables users to configure the 3D Config dialog box parameters (available
during freehand 3D imaging) and to manage user-defined 3D/4D Presets.
The 3D Config dialog box can be configured to appear after 3D Freehand image acquisition
or only when requested (via the touch screen during an exam). This setting applies to all
3D/4D Presets used during freehand image acquisition.
Additionally, user-defined 3D/3D Presets (marked with a key icon) can be renamed or
deleted here.
Note: Factory default Presets are marked with a lock icon adjacent to the Preset name.
They cannot be renamed or deleted.

During imaging, a user-defined Preset name is shown on the LCD display in square
brackets (e.g., [User-Defined Preset]). On the touch screen, user-defined presets are
presented in italics (e.g., User-Defined Preset).

To Configure 3D Settings for freehand image acquisition:

1. Press the console MENU button.
2. From the User Settings menu, select 3D to access 3D Settings.
3. Use the trackball and console SELECT button to configure the 3D Options setting:
Provide 3D Freehand Options After Acquisition.
Note: This is a global option and applies to all 3D/4D Presets.

4. Select OK to accept the setting or Cancel to exit without saving.

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 To Rename User-defined 3D/4D Presets:
1. Press the console MENU button.
2. From the User Settings menu, select 3D to access 3D Settings.
3. Use the trackball and console SELECT button to highlight the user-defined 3D/4D
Preset to be renamed.
Note: User-defined Presets are marked with a key icon.

4. Use the trackball and console SELECT button to select the Rename button.
5. Use the keyboard to enter a new name in the Save Preset dialog box.

Note: The system will not allow duplicate Preset names. If a duplicate name is entered,
a message bubble will prompt for a different name.

6. Select OK to accept the setting or Cancel to exit without saving.

To Delete User-defined 3D Presets:

1. Press the console MENU button.
2. From the User Settings menu, select 3D to access 3D Settings.
3. Use the trackball and console SELECT button to highlight the user-defined 3D/4D
Preset to be deleted.
Note: User-defined Presets are marked with a key icon.

4. Use the trackball and console SELECT button to select the Delete button.
5. Select Yes to accept the deletion or No to exit without deleting the Preset.

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 9.0.8 Display Settings

The Display Settings page enables the adjustment of various display parameters:

Image screen display options:

Displays image screen with high resolution image field and

Image w/ Thumbnails thumbnail images below.
Note: The Ultrasonix recommends this setting
Screen Format

Displays full screen image field with NO thumbnail images.

Reduced image resolution. Provides larger image field for
viewing LCD screen from a distance (i.e., Surgical
Procedures).
Image Only
Caution: Option to display full screen image field may result
in some portions of report page to be clipped with
video out image transfer (VCR, thermal printers,
etc.)

Screen Brightness Adjusts the LCD image screen overall brightness.

Opens the touch panel/screen contrast and brightness

Touchpanel
adjustment controls on the console touch screen.

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9.1 ADMIN SETTINGS

Admin or Administrative Settings allow the system administrator to configure high level system
parameters. Typically these parameters are set at time of initial installation and only require limited
access and adjustment. By default, Admin Settings are not delivered with an active password,
however, as a precaution a password can be applied if desired (see page 121 for details).

To access Admin Settings:

1. Press the MENU button located on the left side of the operator console.
2. From the User Settings menu, select Admin… to access the Admin Settings menu.

9.1.1 System Settings

System Settings are used to configure the Institution Name, Regional Parameters,
Imaging Modes, Shutdown Options, User Data settings and Admin Password.

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 The following settings are available to configure from the System Settings page:

Enter the Institution/Facility Name using the keyboard. The text

Institution Name
entered here appears at the top of the image field.

Interface
Select the desired Interface (Software) Language.
Language
Regional

Internal Select country-specific parameters – date and time formats and

Settings… number display modes.

Date/Time… Configure the actual date and time.

Selecting Direct M-mode automatically displays split screen 2D/M-

mode sweep immediately after pressing M-MODE.
Direct M-mode De-selecting Direct M-mode displays a full screen 2D with M-mode
cursor line immediately after pressing M-MODE. Requires pressing
of UPDATE button to activate M-mode sweep.
Imaging Modes

Selecting Direct Doppler automatically displays split screen

2D/Doppler trace immediately after activating Doppler mode.
Direct Doppler De-selecting Direct Doppler displays a full screen 2D with Doppler
SV cursor immediately after pressing Doppler. Requires pressing of
UPDATE button to activate the Doppler trace.

Opens Doppler and M-mode screen layouts configuration page.

• Side by side Display
Screen Layouts… • Split 1:1......................... (½ 2D – ½ Trace)
• Large Trace Display...... (⅓ 2D – ⅔ Trace)
• Small Trace Display...... (⅔ 2D – ⅓ Trace)

Confirm Selecting Confirm Shutdown forces the system to request

Shutdown confirmation when powering down.
Shutdown
Options

Selecting Enable Fast Boot allows the system to power up faster,

Enable Fast Boot by reducing the amount of initial system auto-testing.
(Hibernation mode) Ultrasonix recommends de-selecting this feature occasionally in
order to ensure maximum system performance.
Imports user-configured system data from a USB storage device
previously exported from a SONIX system.
Import… Data transferred: DICOM setups, user-created tables, user-
configured annotations and pictograms, user-defined imaging
User Data

presets and user-defined setups for font and caliper color and size.
Exports user-configured system data to a USB storage device.
Export… Data retrieved: DICOM setups, user-created tables, user-configured
annotations and pictograms, user-defined imaging presets and user-
defined setups for font and caliper color and size.
Restore Factory Reset system to Factory Defaults.

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 Admin Enables creation/removal of a global, administration level password
Password… in order to protect Admin Settings configuration.

This tool is used to insert text symbols that are not available on the
Insert Symbol
keyboard (e.g., apostrophe).

To password protect Admin Settings access:

1. Press the MENU button located on the left side of the operator console.
2. From the User Settings menu, select Admin… to access the Admin Settings menu.
3. Select System from the Admin Settings menu.
4. Select Admin Password.
5. Enter a password when prompted by the message box.

6. Select OK to accept the password or Cancel to exit without saving.

9.1.2 Software Updates

Software updates can be completed through the Software Updates option on the Admin
Settings menu, via the internet, with a CD or with a USB key.
Note: Access to Software Updates is available only with a valid warranty license.

To perform a Software Update:

1. Press the MENU button located on the left side of the operator console.
2. From the User Settings menu, select Admin… to access the Admin Settings menu.
3. Select Software Updates from the Admin Settings menu.

Release Notes Link

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 4. Select an Update Location from the drop down menu:
• Internet: If the system is connected to the Internet, an automatic search for
available software updates occurs. If successful, the Available
Updates drop down menu populates with the software revisions
available for download. The latest revision is automatically
selected but older software revisions are also available.
• CD and USB: If no internet connection is available, the update can be performed
by accessing a CD or USB port. Select the desired item from the
Available Updates drop down menu,
Note: The CD and/or USB must be inserted prior to selecting
Software Update from Admin Settings in order to appear
in the Update Location drop down menu.

5. Select Release Notes to access the link to the revision history window.
Note: An internet connection is required to access Release Notes.

6. Select Update to begin the update process or Cancel to leave exit without updating.
Note: The Update Progress bar displays the download progress. Upon completion of
the download process, the software update is auto installed on the system and
the system will restart automatically.

9.1.3 Licensing and System Options

Licensing displays the Options available on the SONIX system. When additional features
are enabled, their Status and Expiry dates will be listed in the appropriate columns.

Add License
Text Box

Show Key Local Drive Button

Separations

Add License Button

Note: To obtain a new license key and enable features, please contact your Ultrasonix
representative.

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 To access the Licensing (System Options) Page:
1. Press the MENU button located on the left side of the operator console.
2. From the User Settings menu, select Admin… to access the Admin Settings menu.
3. Select Licensing from the Admin Settings menu.
4. The Licensing Status list details the specifics of the system’s Options, their Status
(Active, Expired, etc.) and the applicable Expiry date.
Note: An Option that has its Status listed as “Active” but has no entry in the Expiry
field will never expire.
5. Enter the new license key in the Add License text box.
• If the new license key is being entered manually, select the Show Key
Separations check box to enable the entry of the key block-by-block. If it is
typed in as one long text sting, the dashes (“-“) will also have to be entered in
order to ensure the License Key format conforms to the required standard.
• If the new license key has been received in an electronic format that lends
itself to the standard “copy and paste” method, do not select the Show Key
Separations check box. Simply copy the key and paste it into the Add
License text box as one long string, with the formatting intact.
Note: As an alternative, add a new license key by selecting the Local Drive…
button and choosing a license file (*.key) to import/enable the new license.

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 9.1.4 DICOM Configuration

The system uses the Digital Imaging and Communications in Medicine (DICOM) standard
to share medical information with other digital imaging systems. The SONIX system, by
means of the DICOM protocol, communicates with Storage, Print and Modality Worklist
Service Class Providers. DICOM setup/configuration is an Administrative level setup and
may be password protected by the User. Refer to section 9.1.9 to configure the system for
network connectivity.
A Text Symbol Insert tool is available on the DICOM configuration pages to enable
entering of text symbols not available on console keyboard (e.g., Underscore).

To configure for DICOM connectivity:

1. Select DICOM from the Admin Settings. The DICOM Configuration page appears on
the display with a section for each of the DICOM features (Storage, Print, Worklist)
2. To activate/deactivate access to a DICOM feature, select/de-select the appropriate
“Turn on…” check box beside the desired feature.
3. The Settings menu to the right of the screen becomes available when the DICOM
feature is activated.

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 9.1.4.1 DICOM Storage Configuration:

The DICOM Storage Settings pages offer basic and advanced settings for configuring the
SONIX system for DICOM Image Storage.

To configure the DICOM storage setting:

1. Select Settings next to the “Turn on DICOM Storage” checkbox on the DICOM
configuration screen.
2. An onscreen menu with four (4) tabs to configure appears on the screen:
• AE (Application Entity) Configuration
• Storage Settings
• Brightness/Contrast
• Storage Commitment

The DICOM Storage AE Configuration property page enables configuration of Application

Entity properties:

Local Host Properties (SCU – Service Class User) – SONIX system

Application Entity
AE Title of the SONIX system
(AE) Title
Port Listening port of the SONIX system (unused).

IP Address Unique identifier of the SONIX system (for information only).

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 Remote Host Properties (SCP – Service Class Provider)

Application Entity
AE Title of the Storage SCP.
(AE) Title
Port Listening port of the Storage SCP.

IP Address Unique identifier of Storage SCP.

Select to send verification request to DICOM storage device (ping

Connection Test
to verify connection).
Text Symbol Insert Used to insert text symbol not available from console keyboard.

The DICOM Storage Settings property page specifies how images are stored:

Store Greyscale Images Select to store images as greyscale images.

Select to swap the color components of the image pixel data—

Convert BGR to RGB
the blue colors are swapped with the red colors.

Lossy Compression
Select the quality (1%–100%) of image compression.
Quality
Select the image storage location (local or remote folder
directory) where the images will be stored.
Storage Location Note: If a value is specified, the AE Configuration and Storage
Commit pages are disabled – images can not be stored
to a SCP.

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 Select the location of a script that will be run immediately
Script Location before images are stored (e.g. a script to run filters on images
before storing them).

Select to ensure system messages are displayed on the

Show Error Balloons screen that inform user about DICOM image storage issues
(i.e., “failed to connect to DICOM).

The DICOM Storage Brightness/Contrast property page changes the brightness and
contrast settings. These settings are applied to the images that are sent to the SCP not the
images stored locally. The effects of these settings can be seen in the Before and After
images.

Contrast Adjusts the level of contrast applied to the images.

Brightness Adjusts the level of brightness applied to the images.

Resets the values of the DICOM storage contrast and

brightness back to zero.

Reset Note: To adjust the brightness/contrast settings, position the

trackball arrow over the brightness or contrast slider,
hold down the Select button at the same time as
moving the trackball left or right to the desired position.

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 The DICOM Storage Commitment property page enables configuration of the Storage
Commitment AE.
Check “Turn on Storage Commitment” to enable Storage Commitment feature.

Local Host Properties of Storage Commitment SCU ( Service Class User) – SONIX
system:
SCU AE Title AE Title of the SONIX system.

SCU Port Listening port of the SONIX system.

SCU Host Name Host name of the SONIX system SCU (for information only).

Remote Host Properties SCP ( Service Class Provider):

SCP AE Title AE Title of the Storage Commitment SCP

SCP Port Listening port of the Storage Commitment SCP.

SCP Host Name Host name of the Storage Commitment SCP

Storage Commitment Listener AE:

AE Title AE title of the Storage Commitment Listener SCU.

Port Listening port

Packet Data Unit

PDU size in bytes.
(PDU) Size
Text Symbol Insert Use to insert text symbol not available on console keyboard.

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 9.1.4.2 DICOM Print Configuration:

The DICOM Print Settings pages offer basic and advanced settings for configuring the
SONIX system for DICOM Print.

To configure the DICOM print setting:

1. Select Settings next to the “Turn on DICOM Print” checkbox.
2. An onscreen menu with four (4) tabs to configure appears on the screen:
• AE Configuration
• Print Settings
• Advanced Print Settings
• Brightness/Contrast

The DICOM Print AE Configuration property page enables configuration of Application

Entity properties:

Local Host Properties SCU (Service Class User) – SONIX System

Application Entity (AE) Title AE Title of the SONIX system
Port Listening port of the SONIX system (unused).

IP Address Unique identifier of the SONIX system (for information only).

Remote Host Properties SCP (Service Class Provider)

Application Entity (AE) Title AE Title of the Print SCP.

Port Listening port of the Print SCP.

IP Address Unique identifier of Print SCP.

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 Select to send verification request to DICOM print device
Connection Test
(ping to verify connection).

Used to insert text symbol not available from console

Text Symbol Insert
keyboard.

The Print Settings property page enables configuration of general print properties:

Select to print images in color, otherwise they are printed in

Print in Color
greyscale. Default is unchecked (print in greyscale)
Reversed Brightness Select to print images in reversed brightness.

Columns Select the number of columns per page.

Rows Select the number of rows per page.

Number of Copies Select the number of copies of each page to be printed.

Select the type of medium that images are printed on (Paper,

Medium Type
Clear Film or Blue Film).

Print Priority Select the print job priority (High, Medium or Low).

Film Destination Select the location print is sent to (processor or magazine).

Text Symbol Insert Use to insert text symbol not available on console keyboard.

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 The Advanced Print Settings property page enables configuration of advanced print
properties:

Orientation Select the orientation of the print page.

Size Select the size of the print page.

Magnification Select the method of magnification used.

Select the smoothing. Printer specific – only available if

Smoothing
Cubic Magnification is selected.

Trim Select Yes or No to use a border (trim) on each page.

Border Density Enter the border density in hundredths of OD.

Empty Density Enter the empty density in hundredths of OD.

Minimum Density Enter the minimum image density.

Maximum Density Enter the maximum image density.

Configuration Information Enter printer specific configuration information.

Polarity Enter the type of polarity to be used.

Image Size Printer specific image size in mm.

Use to insert text symbol not available on console

Text Symbol Insert
keyboard.

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 The DICOM Print Brightness/Contrast property page changes the brightness and contrast
settings:
These settings are applied to the images that are sent to the SCP not to the images stored
locally.
The effect of these settings can be seen in the Before and After images

Contrast Adjusts the level of contrast applied to the images.

Brightness Adjusts the level of brightness applied to the images.

Resets the values of the DICOM print contrast and brightness back to zero.
Note: To adjust the brightness/contrast settings, position the trackball
Reset arrow over the brightness or contrast slider, hold down the Select
button at the same time as moving the trackball left or right to the
desired position.

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 9.1.4.3 DICOM Worklist Configuration:

The DICOM Worklist Settings pages offer advanced settings for configuring the DICOM
Worklist SCU (Service Class User).

To configure the DICOM Worklist settings:

1. Select Settings next to the “Turn on DICOM Worklist” checkbox.
2. An onscreen menu with two tabs appears on the display to configure:
• AE Configuration

The DICOM Worklist AE Configuration property page enables configuration of Application

Entity properties.

Local Host Properties SCU (Service Class User) – SONIX System

Application Entity (AE) Title AE Title of the SONIX system.
Port Listening port of the SONIX system (unused).
IP Address Unique identifier of the SONIX system (for information only).

Remote Host Properties SCP (Service Class Provider)

Application Entity (AE) Title AE Title of the Worklist SCP.
Port Listening port of the Worklist SCP.
IP Address Unique identifier of Worklist SCP.
Select to send verification request to DICOM Worklist device
Connection Test
(ping to verify connection).
Used to insert text symbol not available from console
Text Symbol Insert
keyboard.

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 9.1.5 Peripherals

The Peripheral setup pages enable software configuration for the various peripherals that
are approved to connect to the SONIX ultrasound system. For installation details of
peripheral connections refer to Chapter 10 - Connectivity and Peripherals.
To access the Peripherals setup pages, select Peripherals from the Admin Settings
menu.

The peripherals menu tabs appear on the screen. Select the tab for the desired peripheral:
• Paper Printer
• Monitor (LCD)
• VCR/Photo
• Footswitch

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 9.1.5.1 Paper Printer Configuration:

The Paper Printer configuration page is used to enable a regular laser or inkjet paper
printer connected to the system. If the printer is connected via a parallel or USB port, the
system will recognize the printer and subsequently list it as a recognized printer at the top
of the Paper Printer tab.

To configure the system for a paper printer:

1. Select the printer from the list of recognized printers. If there are multiple printers, press
the UPDATE (right-click) button on the operator console and select Set as Default
Printer from the onscreen menu.
Note: The selected printer can be a network or a local printer and can be configured
for specific formats by selecting Preferences.

2. To select/de-select Image Sheet Printing (e.g., 2 x 3 image sheets), check/uncheck the

Enable box.
3. Enter the number of columns and rows desired in the text boxes provided.
4. To add an optional Header or Footer to the image sheet, enter the desired text in the
boxes provided. (or to supply special commands as required).
Notes: To configure a PRINT button on the operator console to send images to the
default printer, refer to section 9.1.7 Print Keys in System Setup.
To send partial print pages (i.e., 3 images remaining on a 4 image/sheet format)
at the end of an exam, select END EXAM on the patient management ID page
accessed through the ID button on the left side of the operator console.

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 9.1.5.2 Monitor Settings:

The following LCD monitor settings are available to adjust:

• Saturation
• Hue
• Gamma
• Brightness
• Contrast
• Color Mode
• Gain (Red, Green and Blue)

To adjust the various LCD monitor settings:

1. Position the trackball arrow over the desired setting slider, hold down the SELECT
button while moving the trackball left or right to the desired position.
2. Select Restore Factory to restore the default monitor settings.

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 9.1.5.3 VCR Configuration:

On the VCR/Photo configuration page, enable or disable the live output video.
The output video includes only the image area (or full screen when a dialog such as Patient
Management ID page, 3D/4D rendering screen and Image Review pages are displayed on
the screen). The output video does not include the thumbnail images.

9.1.5.4 Footswitch Configuration:

The footswitch configuration page enables the user to configure the desired operation of
the footswitch: Print or Freeze.
To set the operation of the footswitch, select the desired action from the drop down menu.

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 9.1.5.5 Brightness/Contrast:

The brightness/contrast tab enables users to change the brightness/contrast of images

transferred to peripherals to ensure optimum quality on the specified peripherals. The
brightness/contrast values set on this tab are not applied to the image on the screen or
images stored to the system.

The effects of the brightness/contrast settings are seen in Before and After images.

To adjust the brightness and contrast settings:

1. Position the trackball arrow over the brightness or contrast slider, hold down the
SELECT button while moving the trackball left or right to the desired position.
2. Select Reset to restore the default brightness/contrast settings.

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 9.1.6 Patient Settings

Patient Settings allows users to configure options for both Patient Information input and
the on-screen display of patient data.

To access the Patient Settings Page:

1. Press the MENU button located on the left side of the operator console.
2. From the User Settings menu, select Admin… to access the Admin Settings menu.
3. Select Patient from the Admin Settings menu.

The patient data entry fields available on the Patient Management data
entry page are listed on the left hand side of the page. Select/de-select
the patient fields as desired. Selected patient fields appear on the
Patient Management data entry page.
There are three (3) user-defined data entry fields which can be
created. Select Custom 1, Custom 2 or Custom 3 and create the
desired label in the Field Title text entry box (i.e., Nationality). The
customized label appears as one of the data entry fields on the Patient
Management data entry page.
Field Settings
Note: Entries in the Reporting Physician, Referring Physician,
Operator ID, Exam Type, Clinical Indication and Custom 1, 2
and 3 fields can now be edited/maintained from this page
without affecting existing patient data.
Deleting data from any of these fields (e.g., an Operator’s ID)
does not affect existing patient data. It simply removes that data
from the drop down menu on the Patient Information page.
Deleted data can always be re-added at a later date, either here
or when completing a Patient Information page.

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 General Options control the ability to include/exclude or display/hide
certain fields in the Patient Bar on the imaging screen.

Patient Information Bar Display Options

Patient ID The option selected here (Patient ID or Accession #) will be displayed
OR in the Patient Information Bar along the top of the monitor during an
General Options

Accession # exam

The option selected here (LMP or GA) will be displayed in the Patient
LMP
Information Bar along the top of the monitor during an exam.
OR
Note: If GA is chosen, it will only be visible if an obstetrical Preset is
GA selected.

Hide Patient Select/de-select this field to display/hide the Patient Information

Information during an exam.
Capitalize Patient Select this option to capitalize all letters in a patient’s name or
Names and Patient ID identification number.
Default Sex
When Default to last selected text is chosen, opening a fresh
Patient Management ID page will result in the Sex field being
Default to last populated with the same gender that was selected in the last patient
selected text management ID page.
Default Selection Settings

OR When Select default sex is chosen, the user must also select a
specific sex from the drop down menu. The sex selected will then
Select default sex become the default and be automatically entered in the Sex field of
every new patient record that is created. There are four (4) choices
available: Female, Male, Other, Unknown.

Default Application
Select Default to last selected application to configure the patient
management ID page to set the Application field to the last selected
Default to last clinical application.
selected application
When Select default application is chosen, the user must also
OR select a specific application from the drop down menu. The
Select default application selected will then become the default and be
application automatically entered in the Application field of every new patient
record that is created. There are four (4) choices available: Cardiac,
OB, Gyn, Other

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 9.1.7 Print Keys

Print Keys setup enables users to configure the three (3) PRINT buttons located on the
bottom right of the operator console (directly above the FREEZE button).
There are three (3) Print Keys setup pages. They are accessible by selecting the Print 1,
Print 2 or Print 3 tab, which correspond to the PRINT 1, PRINT 2 and PRINT 3/ARCHIVE
console buttons, respectively. Each print tab (and therefore each console PRINT button)
can be configured to trigger one or multiple actions:
Note: Multiple actions can be configured and performed per PRINT button.

To access the Print Keys setup pages:

1. Press the MENU button located on the left side of the operator console.
2. From the User Settings menu, select Admin… to access the Admin Settings menu.
3. Select Print Keys from the Admin Settings menu.

This setting is always selected by default and can only be deselected (or
reselected) if:
1. Trigger is selected.
2. No other Print Keys options are selected.
Store Locally
When selected, regardless of other settings, images will always be saved to
the system’s local storage address.
Note: Access to locally stored images is through Patient Management -
Image Review.

DICOM Store sends images to a DICOM archiver. Refer to 9.1.4 DICOM

DICOM Store
Configuration, for details on DICOM Store configuration.

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 Selecting this setting will configure the system to send output to a paper
Printer
printer. Refer to 9.1.5 Peripherals, for details on printer setup.
When selected, this option will be used to generate a trigger signal to
Trigger attached video printers (i.e., Thermal Printer)
(Photo Printer/VCR) Note: To access the Store Locally option (above), this field must be
selected and all other options must be deselected.

When selected, images will be sent to a DICOM printer. Refer to 9.1.4

DICOM Print
DICOM Configuration for details on DICOM Print configuration.
This setting enables the system to be configured to record a cine loop. The
Record Cine loop duration can be set up through the Capture menu (9.1.8 Capture
Settings).
When configured, this allows the user to send animated DICOM to a DICOM
DICOM Store Cine
archiver (9.1.4 DICOM Configuration).
The Archive option provides instant access to the Patient Review screen.
Archive Note: This function is only accessible via the console PRINT 3/ARCHIVE
button (Print 3 tab).

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 9.1.8 Capture Settings

The Capture Settings configuration page enables the user to select between image and
full screen for image storage and configure the loop storage record time.

Select between Full Screen and Image field for still image storage.
Note: “Image” includes image field, imaging parameters and
Still Image

Local Storage patient data bar - the thumbnail images are not included.
“Full screen” includes the entire display including the
thumbnails.

Video Output Unused.

Select the AVI movie Compressor type – MS-CRAM is the default.
Compressor Caution: This setting should not be changed without a thorough
understanding of Compressor types.
Loops

Select the Quick Record Time (1 to 30 seconds) for post recording

(retrospective acquisition). Refer to section 9.1.7 Print Keys to
Quick Record configure the console print button for Quick Record. Quick Record
Time is only available for 2D or 2D/Color imaging.
Note: Longer record time may slow down system performance.

To access the Capture Settings page:

1. Press the MENU button located on the left side of the operator console.
2. From the User Settings menu, select Admin… to access the Admin Settings menu.
3. Select Capture from the Admin Settings menu.

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 9.1.9 Network Configuration (Internet or Dialup)

The Network page enables the user to configure the system’s network connection (Internet
or Dialup).
The Online Remote Support button is used to connect with an Ultrasonix online
technician. An Ultrasonix technician will help configure this option should it ever be
required.

Note: A network connection is required for DICOM image transfer and on-line chat support.

To access the Network page:

1. Press the MENU button located on the left side of the operator console.
2. From the User Settings menu, select Admin… to access the Admin Settings menu.
3. Select Network from the Admin Settings menu.

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 To configure the Network:
1. Press the MENU button located on the left side of the operator console.
2. From the User Settings menu, select Admin… to access the Admin Settings menu.
3. Select Network from the Admin Settings menu.
4. Select either Dialup Internet Connection or Internet Connection using LAN.
• Dialup Internet Connection: Enter Phone Number, Username, Password,
Timeout (seconds).
• Internet Connection using LAN: Select TCP/IP Settings to configure the
TCP/IP (Transmission Control Protocol/Internet Protocol) pages.

5. Enter Server Address and Server Port to configure E-mail Setup.

6. Check the Online Support box to enable On-line Live Chat Support available through
the QSONIX button on the operator console.

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9.2 SERVICE MENU

Access to Service… is password protected and is restricted to certified, Ultrasonix service

representatives.

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CHAPTER 10 - CONNECTIVITY and PERIPHERALS

The SONIX system includes multiple connectivity features that allow the user to attach various types of
peripherals to the system simultaneously. Refer to the service manual for further details on peripherals
connectivity.

Warning: Do not touch the signal input and signal out ports, located within the system case and
the patient simultaneously.

10.0 SYSTEM CASE CONNECTIVITY PANEL

Caution: The system case contains the system PC and internal connectivity panel. Access to the
internal connectivity panel (through the top of the system case) should be restricted to
qualified service personnel only. Contact your local service representative for further
information.

The System Case Connectivity Panel is accessible from the top of the system case.

13
11 12

15 17

14 16
18

4
1

10 19
9

2 3 5 6 7 8

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1 PS2 Mouse port In use by the operator console trackball.

2 PS2 Keyboard port In use by the operator console keyboard.

3 RS232 Serial port In use by the operator console.

A factory installed dongle is connected to this port required to activate

4 Parallel port selected system features. This port may be additionally be used to
connect an Ultrasonix-approved parallel-port printer.

5 Video output port (disabled) Port is disabled.

6 USB ports Two (2) USB ports – In use at front of operator console.
Two (2) additional USB ports. These ports may be used to connect
7 Additional USB ports
printers and other Ultrasonix-approved USB peripherals
Line-in – may be used to connect an Ultrasonix-approved audio input
device.
8 Sound connections
Speaker – In use by system speakers.
Microphone – In use by operator console microphone – disabled.
May be used to connect either:
• an Ultrasonix-approved RGB-Sync
output video device such as a VCR or
DVD recorder. (A custom cable is
9 Video VGA output
provided)
• an Ultrasonix-approved computer
video output device such as a LCD
projector or a VGA monitor.

10 RS232 Serial Port May be used to connect an Ultrasonix-approved RS232 serial device.

11 Speaker power connector In use by the system speakers.

12 System Power Switch In use by the operator console - ON/OFF switch.

Connected to a video splitter module that outputs Black & White (B&W)
and Color video. It will look like one of the two (2) photos, below.
Note: The B&W and Color video outputs are typically routed to the
back connectivity panel. These may also be connected directly
to a video output device. See the “Back connectivity panel”
section for details.

13 Video outputs

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 Digital Video DVI video In use by the system LCD monitor. A DVI splitter may be used to
14
output connect additional Ultrasonix-approved DVI Video output devices.

15 RS232 Serial port In use by the operator console.

The modem line is typically routed directly to the back connectivity

16 Modem connections panel. It may also be connected directly to a phone line from this
location.

17 Console power connector In use by the operator console.

May be used to trigger a freeze or print function by connecting directly

Freeze Bayonet Neill to an Ultrasonix-approved switching device, such as a foot pedal.
18
Concelman (BNC) Refer to section 9.1.5 Peripherals to configure the trigger action of the
Foot Pedal device.
Port may be connected directly to an Ultrasonix-approved triggered
19 Print BNC device, such as a video printer.
Refer to section 9.1.7 Print Keys to configure the print keys.
The Ethernet connection is typically routed to the back connectivity
panel. It may also be connected directly to the Ethernet from this
20 Ethernet location.
This port supports 10/100Mb as well as 1Gb Ethernet connections.

10.1 BACK CONNECTIVITY PANEL

The Back Connectivity Panel can be accessed from the back of the system. The connectors are
routed internally to the system case connectivity panel which enables easy configuration. In its
standard configuration, the panel provides:

B&W video output – this port can be used to connect an Ultrasonix-

approved video output device such as a B&W video printer or a frame
grabber.

Color video output – this port can be used to connect an Ultrasonix-

approved video output device such as a Color video printer, VCR or a frame
grabber.

Net (Network) – this port can be used to connect the system to a network.
This port supports 10Mb/100Mb and 1Gb Ethernet networks.

Phone – this port can be used to connect the system to a phone line for
chat support.

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10.2 FRONT CONSOLE CONNECTIVITY

The SONIX system provides 2 USB ports and a DVD/CD writer at the front of the operator console.

The 2 USB Ports can be used to connect Ultrasonix-approved USB devices such as USB thumb
drives to the system for image file transfer.

10.3 ULTRASONIX-APPROVED DEVICES

Warning: Refer to the Service Manual for connection of AC power for third-party
peripherals. The internal AC connector should only be used with Ultrasonix
certified third-party peripherals.
The power drawn from the internal AC peripheral power cable must not exceed
150W.

The following peripherals have been approved for use with the system:
• USB thumb drive connected to USB port
• SONY B&W Video printer connected to B&W Video and Trigger output
• SONY VCR and SONY DVD Recorder connected to RGB-Sync
• Canon i80 InkJet Printer connected to Parallel Port.

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CHAPTER 11 - IMAGE STORAGE and REVIEW

The SONIX system includes an onboard (local) patient image management system with image storage
and review functionalities. This chapter describes both the image storage and image review
functionalities.

11.0 IMAGE STORAGE

Each time a new patient data is entered into the system ID page, a local file is created for that
patient. All saved images and cine clips are stored in the patient file and organized by exam date
and type. The saved images and cine clips may be retrieved and later transferred to a DICOM
archiver, printer, etc.
The system hard drive capacity for patient data storage is 80 gigabytes. When the hard drive
begins to reach its capacity a message box will send an alert prompting the user to purge old files.
Depending on the number and type of images stored, the system memory can hold up to
approximately 50,000 exams before the hard drive is full. Ultrasonix recommends regular back-up
of patient/image files and regular purging of older patient files.

11.1 IMAGE REVIEW

Select to access Patient Review page

- review current or selected patient(s) image files.

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 To access the Image Review page (3 access methods):
• For current patient, press the console PRINT3/ARCHIVE print button to the right of the
trackball (refer to section 9.1.7 for Print Key configuration). The Image Review window
appears on the monitor with the current exam images.
• With an active patient exam, press the ID button on the console to open the Patient
Management ID screen. Select Review from the onscreen menu. The Image Review
page appears with the current exam.
• Select desired Patient(s) from the Local Patient list on the Patient Management ID
page and select Review from the onscreen menu. The Image Review window appears
on the monitor with the exam files for the selected patient(s).

Note: To review multiple patient files simultaneously, hold down SHIFT (on keyboard) and
select the patients from the list.

Patient data for currently

displayed image file.

Check patient(s) and study(s)

file for image transfer or

White arrow head indicates more images

– trackball arrow cursor triggers scrolling of
thumbnails both to the right and left.

Check to select individual images

for image transfer or deletion.

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 The image review page displays selected patient(s), study(s) and images:
• The current patient data is displayed at the top of the page.
• The Patient Name section contains the list of patient(s) selected from the Patient
Management ID page.
• The Study Date/Exam section displays the exam files/images for the Patient selected above.
The number of images and cine clips stored appears in the right column of the study list.
• By default, if only one patient file is listed in the Patient Name list the system auto displays
the images from that patient’s most recent study.
• If multiple patients are listed, select each of the patients individually to list the exam dates for
that patient.
• Use the screen Layout section to setup the image display area (Single, 2 x 2, etc.). The
default layout is 2 x 2.
• Stored cine clips are identified by a small “movie” symbol on the lower right of the
image thumbnail. When selecting a movie to replay, the movie will replay in the
review window.
• The image thumbnails on the lower portion of the Image Management screen represent all
the available images in the study under review. To scroll through the thumbnails, use the
trackball to move the cursor over to the right or left side of the thumbnails. The thumbnails will
scroll automatically.
• The Image Management section provides a method for deleting images and studies.

Image Management Touch Screen Controls:

Exit Tap to exit the Image Management page.

Tap to select all the lists patients/patient files/images for image transfer or
Select All
deletion.

Tap to initiate image transfer. The “Select Storage Destination” selection

Transfer
page is displayed on the screen.

Tap to delete the selected (checked boxes) patient(s), patient study file(s)
Delete
and/or image(s).

Add Patient Tap to add (check box) the next patient into the queue.

Add Study Tap to add (check box) the next study file to the queue.

Add Image Tap to add (check box) the next image to the queue.

Tap to uncheck (deselect) all patient(s), patient study file(s) and image(s)
Clear Queue
selected.
Use remappable dial below key to select image(s) displayed. Turn dial to the
Image right to select the next image available. Turn the dial to the left to select the
previous image.

Use remappable dial below key to move through thumbnail images. Turn dial
Thumbnail to the right to select the next thumbnail image. Turn dial to the left to select
the previous thumbnail image.

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 Use remappable dial below key to change the display layout (Single, 2x2,
Layout
3x3, etc.).

Tap Patient key. Use remappable dial below the key to page through the list
Patient
of available patients. Press SELECT to select highlighted patient.

Tap Study key. Use remappable dial below the key to page through the list of
Study
available studies. Press SELECT to select the highlighted study file.

Uncheck to de-select Check to select individual images

individual images. for image transfer or deletion.

The following Cine Clip Review controls are available on the touch screen with cine clip
review:

Cine Review Touch Screen Controls: (tap to activate)

Select to toggle between two methods of reviewing the stored loop.
Toggle Repeat - Repeat the clip over/loop – indicated by curved arrow
- Stop clip at end – indicated by straight arrow.

Exit Select to exit the clip review and return to 2D imaging.

Play Select to view the clip.

Pause Select to pause viewing of the stored clip.

Cine Review Touch Screen Controls: (tap to activate and dial to adjust)
FrmByFrm Use to select currently displayed frame – one (1) frame at a time.

Speed Use to select cine review play speed (⅛ , ¼, ½, full (1/1) or double (2/2).

To select/adjust the above touch screen Clip Review controls:

1. Select Review tab from touch screen menu.
2. Tap desired selection (e.g., Speed) from the touch screen menu.
3. Use the remappable dial below the column containing the desired selection to make
the adjustment to the cine review.

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 11.1.1 Deleting Image/Study

To delete individual images:

1. Select the desired patient and study date to display the images.
2. To select the desired image(s), use the trackball and SELECT button to place a check
in the associated box(s) as shown below.
3. Select Delete from the onscreen menu

To delete entire study:

1. Select the desired patient and study date.
2. Select Delete from the onscreen menu or tap Delete on the touch screen.

Check to select individual studies

for image transfer or deletion.

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11.2 IMAGE TRANSFER

The image management system enables users to transfer stored images and cine clips to a
storage medium (DICOM Archiver or Printer, CD, USB key, DVD).
• To select an entire study, check the checkbox for the desired study.
• To select all studies for a patient, check the checkbox for the desired patient.
• To select only desired images, open each study and check the checkbox for the desired
images.

To transfer patient studies:

1. Select the desired patient, study date and/or images. The amount of memory required
is listed in the Image Management section – Queue Size.

2. Select Transfer from the onscreen menu.

3. A message box appears on the screen. A list of the available storage destinations is
displayed. Select the desired Storage Destination. (Insert a USB key or CD/DVD to
display them in the list of destinations.)

Notes:
• Insert a USB key, CD or DVD into the system to have it appear in the list of
destinations.
• Ultrasonix approved digital storage peripherals that are connected to the system
will appear in the list of destinations.
• Checking “Create Patient Disc (Images Only)” in the Patient Disc Option creates
a CD with just the images (directory and measurement data are not included). If
multiple patients are selected with this option, all images will be in one file.
• Select Clear to reset the screen and de-select the patient(s), study(s) and
image(s). Clear does not delete the images – it resets the screen by unchecking
the selections.

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 4. Select the desired Image Format (.png, .jpeg, .bmp, .gif),

5. Select Send to transfer the files and/or images. The original files will remain
unchanged in the Local memory.
Note: The default image format is PNG. Selecting a different image format will extend
the image transfer time since images must be converted from the default PNG to
the selected format.
The average default PNG image size is 100 KB. Converting the image to a
Bitmap (BMP) increases the image size as follows:
• 800 x 600 Bitmap image = approximately 2 MB
• 1024 x 768 Bitmap image = approximately 3 MB.

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CHAPTER 12 - SYSTEM SPECIFICATIONS

Note: Optional features may not be available on all system configurations. Ultrasonix Medical Corporation
reserves the right to alter system specifications at any time.

SONIX OP SONIX SP SONIX RP

Clinical Applications
Abdominal ♦ ♦ ♦
Vascular ♦ ♦ ♦
Small Parts/Breast ♦ ♦ ♦
Obstetrical/Gynecological/Fertility ♦3 ♦3 ♦3
Superficial ♦ ♦ ♦
Musculoskeletal ♦ ♦ ♦
Prostate ♦ ♦ ♦
Basic Adult Cardiac ♦ ♦ ♦

Imaging Modes
B, Dual B, Quad B ♦ ♦ ♦
B/M mode ♦ ♦ ♦
Color, Power and Directional Power Doppler ♦ ♦ ♦
Split B/Color mode ♦ ♦ ♦
Pulsed Wave Doppler (mono and duplex) ♦ ♦ ♦
Triplex mode ♦ ♦ ♦
Clarity (adaptive image adjustment) ♦ ♦ ♦
Real-time Spatial Compound Imaging ♦ ♦ ♦
Tissue Harmonic Imaging (THI) ♦ ♦ ♦
Trapezoidal imaging (linear transducers) ♦ ♦ ♦
Tint (chroma) ♦ ♦ ♦
Panoramic Imaging ♦ ♦ ♦
3D ♦1 ♦ ♦
4D imaging ♦ ♦

Broadband Transducers
4DC6-3/40 broadband (3-6MHz), 40mm radius, 75" (1m90) cable, 4D ♦ ♦
motor-driven electronic curved array transducer
4DC7-3/40 broadband (3-7 MHz) 40 mm radius, 75” (1mm90) ♦ ♦
cable, 4D motor-driven electronic curved array transducer
C5-2/60 broadband (2-5MHz), 60mm radius, 75" (1m90) cable, curved ♦ ♦ ♦
array transducer
C7-3/50 broadband (3-7 MHz), 50mm radius, 75” (1m90) cable, curved ♦ ♦ ♦
array transducer
EC9-5/10 broadband (5-9MHz), 10mm radius, 75" (1m90) cable, ♦ ♦ ♦
endocavity microconvex array transducer
L14-5/38 broadband (5-14MHz), 38mm, 75" (1m90) cable, linear array ♦ ♦ ♦
transducer
L14-5W/60 broadband (5-14MHz), 60mm, 75" (1m90) cable, wide ♦ ♦ ♦
linear array transducer
PA4-2/20 broadband (2-4MHz), 20mm, 75" (1m90) cable, phased array ♦ ♦ ♦
transducer

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 SONIX OP SONIX SP SONIX RP
System Parameters
Digital broadband channels 512 1024 1024
Maximum frames/sec 223 223 >500
Maximum Display Size 1024x768 1024x768 1600x1200
Dynamic range (Internal) 262dB 262dB 262dB
Dynamic range (Display) 45 - 105dB 45 - 105dB 45 - 105dB
Physical Characteristics
Small footprint: 53cm x 61cm (21" x 24") ♦ ♦ ♦
Height: 145 cm (57”) ♦ ♦ ♦
Weight: 68 kg (150 lbs) ♦ ♦ ♦
ErgoMetrics console ♦ ♦
TFT Matrix 17" LCD monitor ♦ ♦ ♦
Transducer connectors 3 3 3
Peripheral Bay ♦ ♦ ♦

Presets
Default presets ♦ ♦ ♦
Unlimited user presets ♦ ♦ ♦

User Interface
QSONIX (quick exam start) ♦ ♦ ♦
Universal language option ♦ ♦ ♦
TGC, B mode gain ♦ ♦ ♦
Color gain, Spectral gain ♦ ♦ ♦
Depth selection from 2 to 24 cm (transducer dependent) ♦ ♦ ♦
Focus (up to 5 transmit zones with span) ♦ ♦
Focus (up to 10 transmit zones with span) ♦
Persistence (B Mode) ♦ ♦ ♦
Persistence (Color and Spectral Doppler) ♦ ♦ ♦
Acoustic Power ♦ ♦ ♦
Dynamic range ♦ ♦ ♦
Sector size ♦ ♦ ♦
Zoom ♦ ♦ ♦
Color maps ♦ ♦ ♦
Line density (B Mode) ♦ ♦ ♦
Line density (Color and Spectral Doppler) ♦ ♦ ♦
Steer (B Mode) ♦ ♦ ♦
Steer (Color and Spectral Doppler) ♦ ♦ ♦
Baseline, PRF (Color and Spectral Doppler) ♦ ♦ ♦
Display method (scroll or moving bar, Spectral Doppler, B/M) ♦ ♦ ♦
Sweep Speed (M Mode, PW) ♦ ♦ ♦
Automatic optimization key (Spectral Doppler) ♦ ♦ ♦
Simplicit (User Interface) ♦ ♦ ♦
LCD touch screen command centre ♦ ♦ ♦
User-programmable Print keys ♦ ♦ ♦
Text , Annotations, Pictograms ♦ ♦ ♦

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 SONIX OP SONIX SP SONIX RP
Remote Support
Real-time live chat support ♦3 ♦3 ♦3
Ultrasonix remote system diagnostic capability ♦3 ♦3 ♦3
1-Step Software upgrades (CD-ROM or Internet)* ♦3 ♦3 ♦3

Cine Memory
Up to 4 minutes of data (Transducer/sector size dependant) ♦ ♦ ♦
Total available memory >2048 fr >2048 fr >2048 fr
Storage and Connectivity
DICOM service classes (Print/Store/Worklist) ♦ ♦ ♦
Hard-drive storage ♦ ♦ ♦
Still image storage (JPG, DICOM, BMP, TIF) ♦ ♦ ♦
Cineloop storage & trim (AVI, MPEG) – 2D only ♦ ♦ ♦
Front-load integrated CD and DVD-Writer ♦ ♦ ♦
Front-load USB 2.0 ports (2) ♦ ♦ ♦
Built-in Firewall ♦ ♦ ♦
Video output - Composite Color ♦ ♦ ♦
Video output - Composite B&W ♦ ♦ ♦
Video output - Separate VGA output ♦ ♦ ♦
Video output - S-Video out ♦ ♦ ♦
Video output – Digital video DVI output ♦ ♦ ♦
Video input - S-Video ♦ ♦ ♦
Serial connector ♦ ♦ ♦
Parallel and USB standard inkjet or laser printer output ♦ ♦ ♦
Integrated modem and Network connection ♦ ♦ ♦

Measurements and Analysis

Obstetrical calculation package ♦ ♦ ♦
Gyn/Fertility calculation package ♦ ♦ ♦
Basic Cardiac calculation package ♦ ♦ ♦
Vascular calculation package ♦ ♦ ♦
Use of HTML based reports and tables ♦ ♦ ♦

Peripherals
Color Video Printer (option) ♦ ♦ ♦
B/W Video Printer (option) ♦ ♦ ♦
VHS Video Cassette recorder (option) ♦ ♦ ♦
Footswitch (option) ♦ ♦ ♦
MO Drive (option) ♦ ♦ ♦

Non Clinical Applications (For Investigational Use Only)

Research Package ♦
Pre-beamforming realtime acquisition software ♦
RF mode ♦
SDK for Client Applications ♦

♦1 OP 3D software option.
♦2 Where available. Requires Internet connection and ISP.
♦3 Ultrasonix Medical Corporation is not responsible for misdiagnosis from customized measurements.

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12.0 TRANSDUCER SPECIFICATIONS

Transducer Name Type Applications

4DC6-3/40 3D Abdominal Obstetrics, Abdomen, Gyn
4DC7-3/40 3D Abdominal Obstetrics, Abdomen, Gyn
C5-2/60 Convex Abdomen, Obstetrics, Gyn/Fertility
C7-3/50 Convex Abdomen, Obstetrics, Gyn/Fertility
EC9-5/10 Endocavity Transvaginal, Transrectal
L14-5/38 Linear Small parts, Superficial, Msk, Vascular, Superficial Abd
L14-5W/60 Wide Linear Small parts, Superficial, Msk, Vascular, Superficial Abd
PA4-2/20 Phased array Abdomen, Cardiac (Adult), OB/Gyn

12.1 MEASUREMENT ACCURACY

12.1.1 Geometric Measurement Accuracy

For modes including: B, M, Color Flow and Pulsed Doppler

Measurements Transducers

Accuracy:
L14-5/38,
C5-2/60
L14-5W/60, PA4-2/20
C7-3/50
EC9-5/10
Axial Distance 99.2% 96.9% 98.7%
Lateral Distance 98.7% 98.8% 99.4%
Diagonal Distance 97.9% 97.6% 96.6%
Elliptical Area 94.4% 94.4% 92.1%
Elliptical Circumference 96.4% 96.5% 94.5%
Traced Area 97.1% 96.5% 86.2%
Traced Circumference 89.3% 92.4% 91.9%
M-mode Depth (M-display only) 99.0% 98.0% 98.8%

Accuracy is defined as how exact or precise we can make a measurement. For example if we are
measuring a 1.0 cm diagonal distance with a convex transducer, we should be able to measure
within +/- 0.02 cm on our system. (1.0 – (1.0 * 0.979)) = 0.021.

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 Range:
L14-5/38,
C5-2/60
L14-5W/60, PA4-2/20
C7-3/50
EC9-5/10
Axial Distance 1mm – 300mm 0.5mm – 70mm 0.5mm – 120mm
Lateral Distance 1mm – 250mm 0.5mm – 40mm 0.5mm – 200mm
Diagonal Distance 1mm – 300mm 0.5mm – 80mm 0.5mm – 250mm
Elliptical Area 0.1cm2 – 400cm2 0.05cm2 – 154cm2 0.05cm2 – 200cm2
Elliptical Circumference 1mm – 500mm 0.5mm – 220mm 0.5mm – 300mm
Traced Area 0.1cm2 – 400cm2 0.05cm2 – 154cm2 0.05cm2 – 200cm2
Traced Circumference 1mm – 500mm 0.5mm – 220mm 0.5mm – 300mm
M-mode Depth (M-display only) 0.5mm – 300mm 0.5mm – 70mm 0.5mm – 120mm

Methodology:

Testing done on Multipurpose Phantom, ATS Laboratories, Serial no: 305332/0.5.

Various measurements attempted on wires and other structures inside phantom. 5 of each
measurement were performed (per transducer), each trial measuring a unique distance, area or
circumference.

Protocol Steps:
• Turn on ultrasound system
• Select Transducer and Mode
• Complete series of measurements (e.g. 1 Axial Distance, 1 Elliptical Area, 1 Traced
Circumference etc.)
• Repeat Step 3 five times for each transducer.
• Repeat Step 2 for all transducers.

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 12.1.2 Non-Geometric Measurement Accuracy

For modes including: M-mode and Pulsed Doppler

Measurements Transducers

Accuracy:
L14-5/38,
C5-2/60
L14-5W/60, PA4-2/20
C7-3/50
EC9-5/10
M-mode time/frequency 99.2% 99.5% 99.3%
M-mode velocity 98.2% 98.1% 97.6%
Doppler time/frequency 100% 100% 100%
Doppler velocity 93.4% 95.1% 96.4%
Doppler acceleration 92.4% 94.3% 94.6%

Range:
L14-5/38,
C5-2/60
L14-5W/60, PA4-2/20
C7-3/50
EC9-5/10
M-mode time/frequency 0.01s – 7.5s 0.01s – 7.5s 0.01s – 7.5s
M-mode velocity ±0.5cm/s – ±60cm/s ±0.5cm/s – ±60cm/s ±0.5cm/s – ±60cm/s
Doppler time/frequency 0.01s – 7.5s 0.01s – 7.5s 0.01s – 7.5s
Doppler velocity ±0.1cm/s – 50cm/s ±0.1cm/s – 50cm/s ±0.1cm/s – 50cm/s
Doppler acceleration ±1cm/s2 – ±600cm/s2 ±1cm/s2 – ±600cm/s2 ±1cm/s2 – ±600cm/s2

Methodology:

Note that time/frequency measurements accounts for heart-rate.

For time/frequency and velocity measurements, a Doppler phantom was placed beside the
Ultrasonix SONIX system and beside an ATL HDI 5000 system.
Using the equivalent transducers, placed at the exact same position and using the exact same
angles on each system, measurements were taken when the Doppler phantom was running on
Pulsed Flow mode, preset #5.
Values were recorded for 3 different pulse repetition periods for each transducer, except the 4C1,
where 2 different pulse repetition periods were used due to valid ranges we could get for the
particular phantom flow.
These values assumed that the HDI 5000 was calibrated correctly by the manufacturer and that the
measurements taken were accurate within a certain range.
The values measured on the SONIX system were then compared to the values taken from the HDI
5000 and evaluated on accuracy. There is an uncertainty of ± 5% on all velocity values and
time/frequency values.

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12.2 ACOUSTIC OUTPUT TABLES

Track 3 - Acoustic Output Reporting Table

Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: 4DC6-3/40 Operating Mode: B Mode
Index Label MI TIS TIB TIC
Scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 0.60 (a) (a) (a) (a) (a)
Pr.3 [MPa] 1.10
Wo [mW] (a) (a) (a) (a)
min of [W.3(z1) : ITA.3(z1)] [mW] (a)
Z1 [cm] (a)
Assoc. zbp [cm] (a)
Acoustic
Param. zsp [cm] 4.31 (a)
deq(zsp) [cm] (a)
fc [MHz] 3.33 (a) (a) (a) (a) (a)
X [cm] (a) (a) (a) (a) (a)
Dim of Aaprt
Y [cm] (a) (a) (a) (a) (a)
PD [µsec] 0.79
PRF [Hz] 17
pr@PIImax [MPa] 1.80
Other
Information deq@PIImax [cm]
X [cm] (a) (a) (a) (a)
Focal Length
Y [cm] (a) (a) (a) (a)
2
IPA.3@MImax [W/cm ] 38

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
#No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

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 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: 4DC6-3/40 Operating Mode: Color Flow
Index Label MI TIS TIB TIC
Scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 0.58 0.08 (c) (c) (a) 0.15
Pr.3 [MPa] 0.91
Wo [mW] 6 (c) (a) 6
min of [W.3(z1) : ITA.3(z1)] [mW] (c)
Z1 [cm] (c)
Assoc. zbp [cm] (c)
Acoustic
Param. zsp [cm] 4.53 (a)
deq(zsp) [cm] (a)
fc [MHz] 2.50 2.50 (c) (c) (a) 2.50
X [cm] 1.00 (c) (c) (a) 1.00
Dim of Aaprt
Y [cm] 0.80 (c) (c) (a) 0.80
PD [µsec] 1.52
PRF [Hz] 198
pr@PIImax [MPa] 1.34
Other
Information deq@PIImax [cm]
X [cm] 4.53 (c) (c) 4.53
Focal Length
Y [cm] 4.53 (c) (c) 4.53
2
IPA.3@MImax [W/cm ] 64

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
#No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

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 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: 4DC6-3/40 Operating Mode: M Mode
Index Label MI TIS TIB TIC
Scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 0.57 0.03 (c) (c) (c) 0.02
Pr.3 [MPa] 1.04
Wo [mW] 2 (c) (c) 2
min of [W.3(z1) : ITA.3(z1)] [mW] (c)
Z1 [cm] (c)
Assoc. zbp [cm] (c)
Acoustic
Param. zsp [cm] 4.31 (c)
deq(zsp) [cm] (c)
fc [MHz] 3.33 3.33 (c) (c) (c) 3.33
X [cm] 1.00 (c) (c) (c) 1.00
Dim of Aaprt
Y [cm] 2.56 (c) (c) (c) 2.56
PD [µsec] 0.84
PRF [Hz] 125
pr@PIImax [MPa] 1.71
Other
Information deq@PIImax [cm]
X [cm] 4.31 (c) (c) 4.31
Focal Length
Y [cm] 4.31 (c) (c) 4.31
2
IPA.3@MImax [W/cm ] 41

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
# No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

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 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: 4DC6-3/40 Operating Mode: PW Doppler
Index Label MI TIS TIB TIC
Scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 0.46 (c) 1.94 (c) 1.93 3.71
Pr.3 [MPa] 0.73
Wo [mW] (c) 163 169 150
min of [W.3(z1) : ITA.3(z1)] [mW] (c)
Z1 [cm] (c)
Assoc. zbp [cm] (c)
Acoustic
Param. zsp [cm] 4.53 4.53
deq(zsp) [cm] 0.41
fc [MHz] 2.50 (c) 2.50 (c) 2.50 2.50
X [cm] (c) 1.00 (c) 1.00 1.00
Dim of Aaprt
Y [cm] (c) 0.80 (c) 0.80 0.80
PD [µsec] 2.45
PRF [Hz] 1250
pr@PIImax [MPa] 1.08
Other
Information deq@PIImax [cm]
X [cm] (c) 4.53 (c) 4.53
Focal Length
Y [cm] (c) 4.53 (c) 4.53
2
IPA.3@MImax [W/cm ] 26

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
#No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

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 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: 4DC7-3/40 Operating Mode: B Mode
Index Label MI TIS TIB TIC
Scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 0.66 (a) (a) (a) (a) (a)
Pr.3 [MPa] 1.21
Wo [mW] (a) (a) (a) (a)
min of [W.3(z1) : ITA.3(z1)] [mW] (a)
Z1 [cm] (a)
Assoc. zbp [cm] (a)
Acoustic
Param. zsp [cm] 4.36 (a)
deq(zsp) [cm] (a)
fc [MHz] 3.33 (a) (a) (a) (a) (a)
X [cm] (a) (a) (a) (a) (a)
Dim of Aaprt
Y [cm] (a) (a) (a) (a) (a)
PD [µsec] 0.58
PRF [Hz] 17
pr@PIImax [MPa] 2.00
Other
Information deq@PIImax [cm]
X [cm] (a) (a) (a) (a)
Focal Length
Y [cm] (a) (a) (a) (a)
2
IPA.3@MImax [W/cm ] 54

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
#No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

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 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: 4DC7-3/40 Operating Mode: Color Flow
Index Label MI TIS TIB TIC
Scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value .54 0.00 (c) (c) (a) 0.00
Pr.3 [MPa] 0.85
Wo [mW] 0 (c) (a) 0
min of [W.3(z1) : ITA.3(z1)] [mW] (c)
Z1 [cm] (c)
Assoc. zbp [cm] (c)
Acoustic
Param. zsp [cm] 3.82 (a)
deq(zsp) [cm] (a)
fc [MHz] 2.50 2.50 (c) (c) (a) 2.50
X [cm] 0.00 (c) (c) (a) 0.00
Dim of Aaprt
Y [cm] 0.86 (c) (c) (a) 0.86
PD [µsec] 1.64
PRF [Hz] 216
pr@PIImax [MPa] 1.18
Other
Information deq@PIImax [cm]
X [cm] 3.82 (c) (c) 3.82
Focal Length
Y [cm] 3.82 (c) (c) 3.82
2
IPA.3@MImax [W/cm ] 17

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
#No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

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 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: 4DC7-3/40 Operating Mode: M Mode
Index Label MI TIS TIB TIC
Scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 0.51 0.03 (c) (c) (c) 0.03
Pr.3 [MPa] 0.92
Wo [mW] 2 (c) (c) 2
min of [W.3(z1) : ITA.3(z1)] [mW] (c)
Z1 [cm] (c)
Assoc. zbp [cm] (c)
Acoustic
Param. zsp [cm] 3.82 (c)
deq(zsp) [cm] (c)
fc [MHz] 3.33 3.33 (c) (c) (c) 3.33
X [cm] 1.00 (c) (c) (c) 1.00
Dim of Aaprt
Y [cm] 2.75 (c) (c) (c) 2.75
PD [µsec] 0.71
PRF [Hz] 188
pr@PIImax [MPa] 1.43
Other
Information deq@PIImax [cm]
X [cm] 3.82 (c) (c) 3.82
Focal Length
Y [cm] 3.82 (c) (c) 3.82
2
IPA.3@MImax [W/cm ] 24

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
# No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

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 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: 4DC7-3/40 Operating Mode: PW Doppler
Index Label MI TIS TIB TIC
Scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 0.19 (c) 0.25 (c) 0.54 1.06
Pr.3 [MPa] 0.30
Wo [mW] (c) 21 37 44
min of [W.3(z1) : ITA.3(z1)] [mW] (c)
Z1 [cm] (c)
Assoc. zbp [cm] (c)
Acoustic
Param. zsp [cm] 3.82 3.82
deq(zsp) [cm] 0.41
fc [MHz] 2.50 (c) 2.50 (c) 2.50 3.50
X [cm] (c) 1.00 (c) 1.00 1.00
Dim of Aaprt
Y [cm] (c) 0.86 (c) 0.86 0.86
PD [µsec] 2.46
PRF [Hz] 1250
pr@PIImax [MPa] 0.41
Other
Information deq@PIImax [cm]
X [cm] (c) 3.82 (c) 3.82
Focal Length
Y [cm] (c) 3.82 (c) 3.82
2
IPA.3@MImax [W/cm ] 3

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
#No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

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 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: C5-2/60 Operating Mode: B Mode
Index Label MI TIS TIB TIC
Scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 0.92 (a) (a) (a) (a) (a)
Pr.3 [MPa] 1.69
Wo [mW] (a) (a) (a) (a)
min of [W.3(z1) : ITA.3(z1)] [mW] (a)
Z1 [cm] (a)
Assoc. zbp [cm] (a)
Acoustic
Param. zsp [cm] 4.31 (a)
deq(zsp) [cm] (a)
fc [MHz] 3.33 (a) (a) (a) (a) (a)
X [cm] (a) (a) (a) (a) (a)
Dim of Aaprt
Y [cm] (a) (a) (a) (a) (a)
PD [µsec] 0.71
PRF [Hz] 18
pr@PIImax [MPa] 2.77
Other
Information deq@PIImax [cm]
X [cm] (a) (a) (a) (a)
Focal Length
Y [cm] (a) (a) (a) (a)
2
IPA.3@MImax [W/cm ] 81

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
#No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

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 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: C5-2/60 Operating Mode: Color Flow
Index Label MI TIS TIB TIC
Scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 0.67 0.07 (c) (c) (a) 0.13
Pr.3 [MPa] 1.06
Wo [mW] 6 (c) (a) 6
min of [W.3(z1) : ITA.3(z1)] [mW] (c)
Z1 [cm] (c)
Assoc. zbp [cm] (c)
Acoustic
Param. zsp [cm] 4.19 (a)
deq(zsp) [cm] (a)
fc [MHz] 2.50 2.50 (c) (c) (a) 2.50
X [cm] 1.00 (c) (c) (a) 1.00
Dim of Aaprt
Y [cm] 1.00 (c) (c) (a) 1.00
PD [µsec] 1.55
PRF [Hz] 198
pr@PIImax [MPa] 1.52
Other
Information deq@PIImax [cm]
X [cm] 4.19 (c) (c) 4.19
Focal Length
Y [cm] 4.19 (c) (c) 4.19
2
IPA.3@MImax [W/cm ] 67

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
#No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

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 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: C5-2/60 Operating Mode: M Mode
Index Label MI TIS TIB TIC
Scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 0.69 0.08 (c) (c) (c) 0.06
Pr.3 [MPa] 1.25
Wo [mW] 5 (c) (c) 5
min of [W.3(z1) : ITA.3(z1)] [mW] (c)
Z1 [cm] (c)
Assoc. zbp [cm] (c)
Acoustic
Param. zsp [cm] 7.27 (c)
deq(zsp) [cm] (c)
fc [MHz] 3.33 3.33 (c) (c) (c) 3.33
X [cm] 1.00 (c) (c) (c) 1.00
Dim of Aaprt
Y [cm] 3.20 (c) (c) (c) 3.20
PD [µsec] 0.75
PRF [Hz] 157
pr@PIImax [MPa] 2.89
Other
Information deq@PIImax [cm]
X [cm] 4.31 (c) (c) 4.31
Focal Length
Y [cm] 4.31 (c) (c) 4.31
2
IPA.3@MImax [W/cm ] 48

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
#No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

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 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: C5-2/60 Operating Mode: PW Doppler
Index Label MI TIS TIB TIC
scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 0.47 (c) 1.62 (c) 1.66 3.02
Pr.3 [MPa] 0.74
Wo [mW] (c) 136 134 136
min of [W.3(z1) : ITA.3(z1)] [mW] (c)
Z1 [cm] (c)
Assoc. zbp [cm] (c)
Acoustic
Param. zsp [cm] 4.31 4.31
deq(zsp) [cm] 0.41
fc [MHz] 2.50 (c) 2.50 (c) 2.50 2.50
X [cm] (c) 1.00 (c) 1.00 1.00
Dim of Aaprt
Y [cm] (c) 1.00 (c) 1.00 1.00
PD [µsec] 2.29
PRF [Hz] 1250
pr@PIImax [MPa] 1.08
Other
Information deq@PIImax [cm]
X [cm] (c) 4.31 (c) 4.31
Focal Length
Y [cm] (c) 4.31 (c) 4.31
2
IPA.3@MImax [W/cm ] 23

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
#No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

Chapter 12 – System Specifications SUM – 001, Revision C SONIX User Manual

176
 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: C7-3/50 Operating Mode: B Mode
Index Label MI TIS TIB TIC
Scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 0.40 (a) (a) (a) (a) (a)
Pr.3 [MPa] 0.74
Wo [mW] (a) (a) (a) (a)
min of [W.3(z1) : ITA.3(z1)] [mW] (a)
Z1 [cm] (a)
Assoc. zbp [cm] (a)
Acoustic
Param. zsp [cm] 4.28 (a)
deq(zsp) [cm] (a)
fc [MHz] 3.33 (a) (a) (a) (a) (a)
X [cm] (a) (a) (a) (a) (a)
Dim of Aaprt
Y [cm] (a) (a) (a) (a) (a)
PD [µsec] 0.66
PRF [Hz] 18
pr@PIImax [MPa] 1.21
Other
Information deq@PIImax [cm]
X [cm] (a) (a) (a) (a)
Focal Length
Y [cm] (a) (a) (a) (a)
2
IPA.3@MImax [W/cm ] 19

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
#No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

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177
 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: C7-3/50 Operating Mode: Color Flow
Index Label MI TIS TIB TIC
Scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 0.42 0.01 (c) (c) (a) 0.02
Pr.3 [MPa] 0.76
Wo [mW] 1 (c) (a) 1
min of [W.3(z1) : ITA.3(z1)] [mW] (c)
Z1 [cm] (c)
Assoc. zbp [cm] (c)
Acoustic
Param. zsp [cm] 4.28 (a)
deq(zsp) [cm] (a)
fc [MHz] 3.33 2.50 (c) (c) (a) 2.50
X [cm] 1.00 (c) (c) (a) 1.00
Dim of Aaprt
Y [cm] 0.80 (c) (c) (a) 0.80
PD [µsec] 0.69
PRF [Hz] 282
pr@PIImax [MPa] 1.24
Other
Information deq@PIImax [cm]
X [cm] 4.44 (c) (c) 4.44
Focal Length
Y [cm] 4.44 (c) (c) 4.44
2
IPA.3@MImax [W/cm ] 19

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
#No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

Chapter 12 – System Specifications SUM – 001, Revision C SONIX User Manual

178
 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: C7-3/50 Operating Mode: M Mode
Index Label MI TIS TIB TIC
Scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 0.42 0.02 (c) (c) (c) 0.02
Pr.3 [MPa] 0.76
Wo [mW] 1 (c) (c) 1
min of [W.3(z1) : ITA.3(z1)] [mW] (c)
Z1 [cm] (c)
Assoc. zbp [cm] (c)
Acoustic
Param. zsp [cm] 4.28 (c)
deq(zsp) [cm] (c)
fc [MHz] 3.33 3.33 (c) (c) (c) 3.33
X [cm] 1.00 (c) (c) (c) 1.00
Dim of Aaprt
Y [cm] 2.56 (c) (c) (c) 2.56
PD [µsec] 0.69
PRF [Hz] 282
pr@PIImax [MPa] 1.24
Other
Information deq@PIImax [cm]
X [cm] 4.28 (c) (c) 4.28
Focal Length
Y [cm] 4.28 (c) (c) 4.28
2
IPA.3@MImax [W/cm ] 19

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
#No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

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179
 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: C7-3/50 Operating Mode: PW Doppler
Index Label MI TIS TIB TIC
scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 0.27 (c) 0.38 (c) 0.38 0.80
Pr.3 [MPa] 0.43
Wo [mW] (c) 32 32 32
min of [W.3(z1) : ITA.3(z1)] [mW] (c)
Z1 [cm] (c)
Assoc. zbp [cm] (c)
Acoustic
Param. zsp [cm] 4.44 4.44
deq(zsp) [cm] 0.41
fc [MHz] 2.50 (c) 2.50 (c) 2.50 2.50
X [cm] (c) 1.00 (c) 1.00 1.00
Dim of Aaprt
Y [cm] (c) 0.80 (c) 0.80 0.80
PD [µsec] 2.50
PRF [Hz] 1250
pr@PIImax [MPa] 0.63
Other
Information deq@PIImax [cm]
X [cm] (c) 4.44 (c) 4.44
Focal Length
Y [cm] (c) 4.44 (c) 4.44
2
IPA.3@MImax [W/cm ] 4

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
#No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

Chapter 12 – System Specifications SUM – 001, Revision C SONIX User Manual

180
 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: EC9-5/10 Operating Mode: B Mode
Index Label MI TIS TIB TIC
Scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 0.31 (a) (a) (a) (a) (a)
Pr.3 [MPa] 0.70
Wo [mW] (a) (a) (a) (a)
min of [W.3(z1) : ITA.3(z1)] [mW] (a)
Z1 [cm] (a)
Assoc. zbp [cm] (a)
Acoustic
Param. zsp [cm] 2.23 (a)
deq(zsp) [cm] (a)
fc [MHz] 5.00 (a) (a) (a) (a) (a)
X [cm] (a) (a) (a) (a) (a)
Dim of Aaprt
Y [cm] (a) (a) (a) (a) (a)
PD [µsec] 2.79
PRF [Hz] 60
pr@PIImax [MPa] 1.03
Other
Information deq@PIImax [cm]
X [cm] (a) (a) (a) (a)
Focal Length
Y [cm] (a) (a) (a) (a)
2
IPA.3@MImax [W/cm ] 5

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
#No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

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181
 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: EC9-5/10 Operating Mode: Color Flow
Index Label MI TIS TIB TIC
Scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 0.17 0.01 (c) (c) (a) 0.01
Pr.3 [MPa] 0.39
Wo [mW] 0 (c) (a) 0
min of [W.3(z1) : ITA.3(z1)] [mW] (c)
Z1 [cm] (c)
Assoc. zbp [cm] (c)
Acoustic
Param. zsp [cm] 2.35 (a)
deq(zsp) [cm] (a)
fc [MHz] 5.00 5.00 (c) (c) (a) 5.00
X [cm] 0.70 (c) (c) (a) 0.70
Dim of Aaprt
Y [cm] 0.41 (c) (c) (a) 0.41
PD [µsec] 3.21
PRF [Hz] 330
pr@PIImax [MPa] 0.59
Other
Information deq@PIImax [cm]
X [cm] 2.35 (c) (c) 2.35
Focal Length
Y [cm] 2.35 (c) (c) 2.35
2
IPA.3@MImax [W/cm ] 4

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
#No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

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 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: EC9-5/10 Operating Mode: M Mode
Index Label MI TIS TIB TIC
Scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 0.31 0.00 (c) (c) (c) 0.00
Pr.3 [MPa] 0.70
Wo [mW] 0 (c) (c) 0
min of [W.3(z1) : ITA.3(z1)] [mW] (c)
Z1 [cm] (c)
Assoc. zbp [cm] (c)
Acoustic
Param. zsp [cm] 2.23 (c)
deq(zsp) [cm] (c)
fc [MHz] 5.00 5.00 (c) (c) (c) 5.00
X [cm] 0.70 (c) (c) (c) 0.70
Dim of Aaprt
Y [cm] 1.07 (c) (c) (c) 1.07
PD [µsec] 2.95
PRF [Hz] 251
pr@PIImax [MPa] 1.03
Other
Information deq@PIImax [cm]
X [cm] 2.23 (c) (c) 2.23
Focal Length
Y [cm] 2.23 (c) (c) 2.23
2
IPA.3@MImax [W/cm ] 5

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
#No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

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 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: EC9-5/10 Operating Mode: PW Doppler
Index Label MI TIS TIB TIC
scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 0.13 (c) 0.09 (c) 0.03 0.11
Pr.3 [MPa] 0.34
Wo [mW] (c) 3 3 3
min of [W.3(z1) : ITA.3(z1)] [mW] (c)
Z1 [cm] (c)
Assoc. zbp [cm] (c)
Acoustic
Param. zsp [cm] 2.35 2.35
deq(zsp) [cm] 0.21
fc [MHz] 6.66 (c) 6.66 (c) 6.66 6.66
X [cm] (c) 0.70 (c) 0.70 0.70
Dim of Aaprt
Y [cm] (c) 0.41 (c) 0.41 0.41
PD [µsec] 2.41
PRF [Hz] 1250
pr@PIImax [MPa] 0.59
Other
Information deq@PIImax [cm]
X [cm] (c) 2.35 (c) 2.35
Focal Length
Y [cm] (c) 2.35 (c) 2.35
2
IPA.3@MImax [W/cm ] 3

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
#No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

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 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: L14-5/38 Operating Mode: B Mode
Index Label MI TIS TIB TIC
scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 0.96 (a) (a) (a) (a) (a)
Pr.3 [MPa] 2.47
Wo [mW] (a) (a) (a) (a)
min of [W.3(z1) : ITA.3(z1)] [mW] (a)
Z1 [cm] (a)
Assoc. zbp [cm] (a)
Acoustic
Param. zsp [cm] 1.34 (a)
deq(zsp) [cm] (a)
fc [MHz] 6.67 (a) (a) (a) (a) (a)
X [cm] (a) (a) (a) (a) (a)
Dim of Aaprt
Y [cm] (a) (a) (a) (a) (a)
PD [µsec] 0.36
PRF [Hz] 49
pr@PIImax [MPa] 3.36
Other
Information deq@PIImax [cm]
X [cm] (a) (a) (a) (a)
Focal Length
Y [cm] (a) (a) (a) (a)
2
IPA.3@MImax [W/cm ] 230

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
#No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

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 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: L14-5/38 Operating Mode: Color Flow
Index Label MI TIS TIB TIC
scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 0.45 0.02 (c) (c) (a) 0.04
Pr.3 [MPa] 1.02
Wo [mW] 1 (c) (a) 1
min of [W.3(z1) : ITA.3(z1)] [mW] (c)
Z1 [cm] (c)
Assoc. zbp [cm] (c)
Acoustic
Param. zsp [cm] 1.68 (a)
deq(zsp) [cm] (a)
fc [MHz] 5.00 5.00 (c) (c) (a) 5.00
X [cm] 0.70 (c) (c) (a) 0.70
Dim of Aaprt
Y [cm] 0.60 (c) (c) (a) 0.60
PD [µsec] 1.00
PRF [Hz] 299
pr@PIImax [MPa] 1.36
Other
Information deq@PIImax [cm]
X [cm] 1.68 (c) (c) 1.68
Focal Length
Y [cm] 1.68 (c) (c) 1.68
2
IPA.3@MImax [W/cm ] 42

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
# No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.
.

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 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: L14-5/38 Operating Mode: M Mode
Index Label MI TIS TIB TIC
Scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 0.79 0.02 (c) (c) (c) 0.01
Pr.3 [MPa] 2.04
Wo [mW] 1 (c) (c) 1
min of [W.3(z1) : ITA.3(z1)] [mW] (c)
Z1 [cm] (c)
Assoc. zbp [cm] (c)
Acoustic
Param. zsp [cm] 1.67 (c)
deq(zsp) [cm] (c)
fc [MHz] 6.67 6.67 (c) (c) (c) 6.67
X [cm] 0.70 (c) (c) (c) 0.70
Dim of Aaprt
Y [cm] 1.80 (c) (c) (c) 1.80
PD [µsec] 0.39
PRF [Hz] 167
pr@PIImax [MPa] 3.00
Other
Information deq@PIImax [cm]
X [cm] 1.67 (c) (c) 1.67
Focal Length
Y [cm] 1.67 (c) (c) 1.67
2
IPA.3@MImax [W/cm ] 132

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
#No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

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 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: L14-5/38 Operating Mode: PW Doppler
Index Label MI TIS TIB TIC
Scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 0.36 (c) 1.71 (c) 1.29 2.22
Pr.3 [MPa] 0.92
Wo [mW] (c) 54 55 65
min of [W.3(z1) : ITA.3(z1)] [mW] (c)
Z1 [cm] (c)
Assoc. zbp [cm] (c)
Acoustic
Param. zsp [cm] 1.68 1.68
deq(zsp) [cm] 0.21
fc [MHz] 6.66 (c) 6.66 (c) 6.66 6.66
X [cm] (c) 0.70 (c) 0.70 0.70
Dim of Aaprt
Y [cm] (c) 0.60 (c) 0.60 0.60
PD [µsec] 2.24
PRF [Hz] 1250
pr@PIImax [MPa] 1.36
Other
Information deq@PIImax [cm]
X [cm] (c) 1.68 (c) 1.68
Focal Length
Y [cm] (c) 1.68 (c) 1.68
2
IPA.3@MImax [W/cm ] 27

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
#No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

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 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: L14-5W/60 Operating Mode: B Mode
Index Label MI TIS TIB TIC
Scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 1.09 (a) (a) (a) (a) (a)
Pr.3 [MPa] 2.81
Wo [mW] (a) (a) (a) (a)
min of [W.3(z1) : ITA.3(z1)] [mW] (a)
Z1 [cm] (a)
Assoc. zbp [cm] (a)
Acoustic
Param. zsp [cm] 1.34 (a)
deq(zsp) [cm] (a)
fc [MHz] 6.67 (a) (a) (a) (a) (a)
X [cm] (a) (a) (a) (a) (a)
Dim of Aaprt
Y [cm] (a) (a) (a) (a) (a)
PD [µsec] 0.34
PRF [Hz] 51
pr@PIImax [MPa] 3.82
Other
Information deq@PIImax [cm]
X [cm] (a) (a) (a) (a)
Focal Length
Y [cm] (a) (a) (a) (a)
2
IPA.3@MImax [W/cm ] 244

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic
output indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
#No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

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 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: L14-5W/60 Operating Mode: Color Flow
Index Label MI TIS TIB TIC
Scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 0.74 0.05 (c) (c) (a) 0.05
Pr.3 [MPa] 1.66
Wo [mW] 2 (c) (a) 2
min of [W.3(z1) : ITA.3(z1)] [mW] (c)
Z1 [cm] (c)
Assoc. zbp [cm] (c)
Acoustic
Param. zsp [cm] 1.74 (a)
deq(zsp) [cm] (a)
fc [MHz] 5.00 5.00 (c) (c) (a) 5.00
X [cm] 0.70 (c) (c) (a) 0.70
Dim of Aaprt
Y [cm] 0.92 (c) (c) (a) 0.92
PD [µsec] 0.86
PRF [Hz] 351
pr@PIImax [MPa] 2.25
Other
Information deq@PIImax [cm]
X [cm] 1.74 (c) (c) 1.74
Focal Length
Y [cm] 1.74 (c) (c) 1.74
2
IPA.3@MImax [W/cm ] 101

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
#No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

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 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: L14-5W/60 Operating Mode: M Mode
Index Label MI TIS TIB TIC
Scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 0.96 0.03 (c) (c) (c) 0.02
Pr.3 [MPa] 2.49
Wo [mW] 1 (c) (c) 1
min of [W.3(z1) : ITA.3(z1)] [mW] (c)
Z1 [cm] (c)
Assoc. zbp [cm] (c)
Acoustic
Param. zsp [cm] 1.67 (c)
deq(zsp) [cm] (c)
fc [MHz] 6.67 6.67 (c) (c) (c) 6.67
X [cm] 0.70 (c) (c) (c) 0.70
Dim of Aaprt
Y [cm] 2.76 (c) (c) (c) 2.76
PD [µsec] 0.39
PRF [Hz] 167
pr@PIImax [MPa] 3.66
Other
Information deq@PIImax [cm]
X [cm] 1.67 (c) (c) 1.67
Focal Length
Y [cm] 1.67 (c) (c) 1.67
2
IPA.3@MImax [W/cm ] 201

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
#No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

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 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: L14-5W/60 Operating Mode: PW Doppler
Index Label MI TIS TIB TIC
Scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 0.38 (c) 2.06 (c) 1.39 1.69
Pr.3 [MPa] 0.99
Wo [mW] (c) 65 63 61
min of [W.3(z1) : ITA.3(z1)] [mW] (c)
Z1 [cm] (c)
Assoc. zbp [cm] (c)
Acoustic
Param. zsp [cm] 1.74 1.74
deq(zsp) [cm] 0.21
fc [MHz] 6.66 (c) 6.66 (c) 6.66 6.66
X [cm] (c) 0.70 (c) 0.70 0.70
Dim of Aaprt
Y [cm] (c) 0.92 (c) 0.92 0.92
PD [µsec] 2.24
PRF [Hz] 1250
pr@PIImax [MPa] 1.47
Other
Information deq@PIImax [cm]
X [cm] (c) 1.74 (c) 1.74
Focal Length
Y [cm] (c) 1.74 (c) 1.74
2
IPA.3@MImax [W/cm ] 40

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
#No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

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 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: PA4-2/20 Operating Mode: B Mode
Index Label MI TIS TIB TIC
Scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 0.59 (a) (a) (a) (a) (a)
Pr.3 [MPa] 0.94
Wo [mW] (a) (a) (a) (a)
min of [W.3(z1) : ITA.3(z1)] [mW] (a)
Z1 [cm] (a)
Assoc. zbp [cm] (a)
Acoustic
Param. zsp [cm] 5.42 (a)
deq(zsp) [cm] (a)
fc [MHz] 2.50 (a) (a) (a) (a) (a)
X [cm] (a) (a) (a) (a) (a)
Dim of Aaprt
Y [cm] (a) (a) (a) (a) (a)
PD [µsec] 0.76
PRF [Hz] 22
pr@PIImax [MPa] 1.50
Other
Information deq@PIImax [cm]
X [cm] (a) (a) (a) (a)
Focal Length
Y [cm] (a) (a) (a) (a)
2
IPA.3@MImax [W/cm ] 45

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
#No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

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193
 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: PA4-2/20 Operating Mode: Color Flow
Index Label MI TIS TIB TIC
Scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 0.43 0.01 (c) (c) (a) 0.04
Pr.3 [MPa] 0.60
Wo [mW] 1 (c) (a) 1
min of [W.3(z1) : ITA.3(z1)] [mW] (c)
Z1 [cm] (c)
Assoc. zbp [cm] (c)
Acoustic
Param. zsp [cm] 5.94 (a)
deq(zsp) [cm] (a)
fc [MHz] 2.00 2.00 (c) (c) (a) 2.00
X [cm] 1.00 (c) (c) (a) 1.00
Dim of Aaprt
Y [cm] 0.60 (c) (c) (a) 0.60
PD [µsec] 1.09
PRF [Hz] 162
pr@PIImax [MPa] 0.91
Other
Information deq@PIImax [cm]
X [cm] 5.94 (c) (c) 5.94
Focal Length
Y [cm] 5.94 (c) (c) 5.94
2
IPA.3@MImax [W/cm ] 11

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
#No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

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194
 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: PA4-2/20 Operating Mode: M Mode
Index Label MI TIS TIB TIC
Scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 0.38 0.02 (c) (c) (c) 0.02
Pr.3 [MPa] 0.59
Wo [mW] 2 (c) (c) 1
min of [W.3(z1) : ITA.3(z1)] [mW] (c)
Z1 [cm] (c)
Assoc. zbp [cm] (c)
Acoustic
Param. zsp [cm] 4.93 (c)
deq(zsp) [cm] (c)
fc [MHz] 2.50 2.50 (c) (c) (c) 2.50
X [cm] 1.00 (c) (c) (c) 1.00
Dim of Aaprt
Y [cm] 1.92 (c) (c) (c) 1.92
PD [µsec] 1.04
PRF [Hz] 189
pr@PIImax [MPa] 0.91
Other
Information deq@PIImax [cm]
X [cm] 4.99 (c) (c) 4.99
Focal Length
Y [cm] 4.99 (c) (c) 4.99
2
IPA.3@MImax [W/cm ] 14

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
#No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

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195
 Track 3 - Acoustic Output Reporting Table
Acoustic Output Reporting Table for Track 3
(provide data where global maximum displayed index exceeds 1.0)
Transducer Model: PA4-2/20 Operating Mode: PW Doppler
Index Label MI TIS TIB TIC
Scan non-scan non-scan
Aaprt≤1 Aaprt1
Global Maximum Index Value 0.18 (c) 0.69 (c) 0.62 2.81
Pr.3 [MPa] 0.28
Wo [mW] (c) 58 97 98
min of [W.3(z1) : ITA.3(z1)] [mW] (c)
Z1 [cm] (c)
Assoc. zbp [cm] (c)
Acoustic
Param. zsp [cm] 5.94 5.42
deq(zsp) [cm] 0.55
fc [MHz] 2.50 (c) 2.50 (c) 2.50 2.50
X [cm] (c) 1.00 (c) 1.00 1.00
Dim of Aaprt
Y [cm] (c) 0.60 (c) 0.60 0.60
PD [µsec] 3.55
PRF [Hz] 1250
pr@PIImax [MPa] 0.47
Other
Information deq@PIImax [cm]
X [cm] (c) 5.94 (c) 5.42
Focal Length
Y [cm] (c) 5.94 (c) 5.42
2
IPA.3@MImax [W/cm ] 2

Control 1
Operating Control 2
Control
Conditions Control 3
Control n

Notes:
a ) This index is not required for this operating mode;
see section 4.1.3.1 of the Standard for real-time display of thermal and mechanical acoustic output
indices on diagnostic ultrasound equipment (AIUM/NEMA 1998b)
b ) This probe is not intended for trans-cranial or neonatal cephalic uses.
c ) This formulation for TIS is less than that for an alternate formulation in this mode.
#No data are reported for this operating condition since the global maximum index value is not
reported for the reason listed.

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196
12.3 ULTRASOUND INDICATIONS FOR USE TABLES

SONIX Ultrasound Scanner - Diagnostic Ultrasound Indications for Use Form

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Mode of Operation

Clinical Application Color

Color Amplitude Combined Other
A B M PWD CWD Velocity
Doppler Doppler (specify) (specify)
Imaging

Ophthalmic
Fetal P P P P P P P (*1) P (*2)
Abdominal P P P P P P P P (*1) P (*2)
Intraoperative
P P P P P P P (*1) P (*2)
(specify)
Intraoperative
P P P P P P P (*1) P (*2)
Neurological
Pediatric P P P P P P P P (*1) P (*2)
Small Organ (specify) P P P P P P P (*1) P (*2)
Neonatal Cephalic P P P P P P P (*1) P (*2)
Adult Cephalic P P P P P P P (*1) P (*2)
Cardiac P P P P P P P P (*1) P (*2)
Transesophageal P P P P P P P (*1) P (*2)
Transrectal P P P P P P P (*1) P (*2)
Transvaginal P P P P P P P (*1) P (*2)
Transurethral
Intravascular
Peripheral Vascular P P P P P P P (*1) P (*2)
Laparoscopic
MSK Conventional P P P P P P P (*1) P (*2)
MSK Superficial P P P P P P P (*1) P (*2)
Other (specify) (*3) P P P P P P P (*1) P (*2)

N = new indication; P = previously cleared

Additional Comments:
Small Organ: breast, thyroid, testicle
Intraoperative : abdominal organs and vascular
*1. B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
*2. Freehand 3D imaging, live 3D imaging, Directional Power Doppler (DPD)
*3. Transcranial Doppler

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 Diagnostic Ultrasound Indications for Use Form
4DC6-3/40 motorized convex 3.5 MHz 40mm radius transducer

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Mode of Operation

Clinical Application Color

Color Amplitude Combined Other
A B M PWD CWD Velocity
Doppler Doppler (specify) (specify)
Imaging

Ophthalmic
Fetal P P P P P P P (*1) P (*2)
Abdominal P P P P P P P (*1) P (*2)
Intraoperative
(specify)
Intraoperative
Neurological
Pediatric P P P P P P P (*1) P (*2)
Small Organ (specify) P P P P P P P (*1) P (*2)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular P P P P P P P (*1) P (*2)
Laparoscopic
MSK Conventional P P P P P P P (*1) P (*2)
MSK Superficial P P P P P P P (*1) P (*2)
Other (specify) (*3)

N = new indication; P = previously cleared

Additional Comments:
Small Organ: breast, thyroid, testicle
*1. B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
*2. Freehand 3D imaging, Live 3D imaging, Directional Power Doppler (DPD)

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 Diagnostic Ultrasound Indications for Use Form
4DC7-3/40 motorized convex 3/7 MHz 40mm radius transducer

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Mode of Operation

Clinical Application Color

Color Amplitude Combined Other
A B M PWD CWD Velocity
Doppler Doppler (specify) (specify)
Imaging

Ophthalmic
Fetal N N N N N N N (*1) N (*2)
Abdominal N N N N N N N (*1) N (*2)
Intraoperative
(specify)
Intraoperative
Neurological
Pediatric N N N N N N N (*1) N (*2)
Small Organ (specify) N N N N N N N (*1) N (*2)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular N N N N N N N (*1) N (*2)
Laparoscopic
MSK Conventional N N N N N N N (*1) N (*2)
MSK Superficial N N N N N N N (*1) N (*2)
Other (specify) (*3)

N = new indication; P = previously cleared

Additional Comments:
Small Organ: breast, thyroid, testicle
*1. B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
*2. Freehand 3D imaging, Live 3D imaging, Directional Power Doppler (DPD)

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 Diagnostic Ultrasound Indications for Use Form
C5-2/60 convex 3.2 MHz 60mm radius transducer

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Mode of Operation

Clinical Application Color

Color Amplitude Combined Other
A B M PWD CWD Velocity
Doppler Doppler (specify) (specify)
Imaging

Ophthalmic
Fetal P P P P P P P (*1) P (*2)
Abdominal P P P P P P P (*1) P (*2)
Intraoperative
(specify)
Intraoperative
Neurological
Pediatric P P P P P P P (*1) P (*2)
Small Organ (specify) P P P P P P P (*1) P (*2)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular P P P P P P P (*1) P (*2)
Laparoscopic
MSK Conventional P P P P P P P (*1) P (*2)
MSK Superficial P P P P P P P (*1) P (*2)
Other (specify)

N = new indication; P = previously cleared

Additional Comments:
Small Organ: breast, thyroid, testicle
*1. B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
*2. Freehand 3D imaging, Directional Power Doppler (DPD)

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 Diagnostic Ultrasound Indications for Use Form
C7-3/50 convex 3/7 MHz 50mm radius transducer

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Mode of Operation

Clinical Application Color

Color Amplitude Combined Other
A B M PWD CWD Velocity
Doppler Doppler (specify) (specify)
Imaging

Ophthalmic
Fetal N N N N N N N (*1) N (*2)
Abdominal N N N N N N N (*1) N (*2)
Intraoperative
(specify)
Intraoperative
Neurological
Pediatric N N N N N N N (*1) N (*2)
Small Organ (specify) N N N N N N N (*1) N (*2)
Neonatal Cephalic N N N N N N N (*1) N (*2)
Adult Cephalic N N N N N N N (*1) N (*2)
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular N N N N N N N (*1) N (*2)
Laparoscopic
MSK Conventional N N N N N N N (*1) N (*2)
MSK Superficial N N N N N N N (*1) N (*2)
Other (specify)

N = new indication; P = previously cleared

Additional Comments:
Small Organ: breast, thyroid, testicle
*1. B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
*2. Freehand 3D imaging, Directional Power Doppler (DPD)

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 Diagnostic Ultrasound Indications for Use Form
EC9-5/10 microconvex endocavity 6.6 MHz 10mm radius transducer

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Mode of Operation

Clinical Application Color

Color Amplitude Combined Other
A B M PWD CWD Velocity
Doppler Doppler (specify) (specify)
Imaging

Ophthalmic
Fetal
Abdominal
Intraoperative
(specify)
Intraoperative
Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal P P P P P P P (*1) P (*2)
Transvaginal P P P P P P P (*1) P (*2)
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Other (specify) (*3)

N = new indication; P = previously cleared

Additional Comments:
*1. B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
*2. Freehand 3D imaging, Directional Power Doppler (DPD)

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 Diagnostic Ultrasound Indications for Use Form
L14-5/38 linear 8 MHz 38mm transducer

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Mode of Operation

Clinical Application Color

Color Amplitude Combined Other
A B M PWD CWD Velocity
Doppler Doppler (specify) (specify)
Imaging

Ophthalmic
Fetal P P P P P P P (*1) P (*2)
Abdominal P P P P P P P (*1) P (*2)
Intraoperative
(specify)
Intraoperative
Neurological
Pediatric P P P P P P P (*1) P (*2)
Small Organ (specify) P P P P P P P (*1) P (*2)
Neonatal Cephalic P P P P P P P (*1) P (*2)
Adult Cephalic P P P P P P P (*1) P (*2)
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular P P P P P P P (*1) P (*2)
Laparoscopic
MSK Conventional P P P P P P P (*1) P (*2)
MSK Superficial P P P P P P P (*1) P (*2)
Other (specify)

N = new indication; P = previously cleared

Additional Comments:
Small Organ: breast, thyroid, testicle
*1. B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
*2. Freehand 3D imaging, Directional Power Doppler (DPD)

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 Diagnostic Ultrasound Indications for Use Form
L14-5W/60 linear 8 MHz 60mm transducer

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Mode of Operation

Clinical Application Color

Color Amplitude Combined Other
A B M PWD CWD Velocity
Doppler Doppler (specify) (specify)
Imaging

Ophthalmic
Fetal P P P P P P P (*1) P (*2)
Abdominal P P P P P P P (*1) P (*2)
Intraoperative
(specify)
Intraoperative
Neurological
Pediatric P P P P P P P (*1) P (*2)
Small Organ (specify) P P P P P P P (*1) P (*2)
Neonatal Cephalic P P P P P P P (*1) P (*2)
Adult Cephalic P P P P P P P (*1) P (*2)
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular P P P P P P P (*1) P (*2)
Laparoscopic
MSK Conventional P P P P P P P (*1) P (*2)
MSK Superficial P P P P P P P (*1) P (*2)
Other (specify)

N = new indication; P = previously cleared

Additional Comments:
Small Organ: breast, thyroid, testicle
*1. B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
*2. Freehand 3D imaging, Directional Power Doppler (DPD)

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 Diagnostic Ultrasound Indications for Use Form
PA4-2/20 phased array 2.8 MHz transducer

Intended use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows
Mode of Operation

Clinical Application Color

Color Amplitude Combined Other
A B M PWD CWD Velocity
Doppler Doppler (specify) (specify)
Imaging

Ophthalmic
Fetal
Abdominal P P P P P P P P (*1) P (*2)
Intraoperative
(specify)
Intraoperative
Neurological
Pediatric P P P P P P P P (*1) P (*2)
Small Organ (specify)
Neonatal Cephalic P P P P P P P (*1) P (*2)
Adult Cephalic P P P P P P P (*1) P (*2)
Cardiac P P P P P P P P (*1) P (*2)
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
MSK Conventional
MSK Superficial
Other (specify) (*3) P P P P P P P (*1) P (*2)

N = new indication; P = previously cleared

Additional Comments:
*1. B/M, B/PWD, B/CWD, B/CFM/PWD, B/AD/PWD, B/DPD/PWD, B/CFM/CWD, B/AD/CWD, B/DPD/CWD
*2. Freehand 3D imaging, Directional Power Doppler (DPD)
*3. Transcranial Doppler

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CHAPTER 13 - SAFETY, MAINTENANCE and CLEANING

13.0 SAFETY

This section contains important information about the safe use of the SONIX ultrasound system.
Much of the information is required by various regulatory agencies and should be read prior to
using the SONIX ultrasound system.

13.0.1 ALARA Principle and Output Displays

The Acoustic Power Output Display for the SONIX ultrasound system meets FDA
requirements and the guidance standards set out by AIUM and NEMA – “Standard for
Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic
Ultrasound Equipment”.
The SONIX system provides real-time Mechanical Index (MI) and Thermal Index (TI)
acoustic power output display values depending on the transducer and imaging mode.
• MI – Mechanical Index (2D imaging)
• TIB – Bone Thermal Index
• TIC – Cranial Thermal Index
• TIS – Soft Tissue Thermal Index

To change the index value displayed:

1. Press ACOUSTIC POWER button/dial on the right upper portion of the operator
console.
2. Press several times to toggle through the MI, TIS, TIC and TIB values available to
display depending on the imaging mode.

Note: The MI and TI values are displayed to the right of the image field. The MI and TI
values are updated as changes are made to the system, which affect the
acoustic power output.

The ALARA principle, provided by AIUM in “Ultrasound Medical Safety – Implementing

ALARA”, guides the ultrasound user on the prudent use of diagnostic ultrasound. Display of
the acoustic power output value enables the ultrasound user to better implement the
ALARA principle. The ultrasound user can determine the right balance of ultrasound
exposure benefits to risks by using acoustic power output levels that are As Low As
Reasonably Achievable (ALARA). Without compromising diagnostic quality, patient
ultrasound exposure should be kept to a minimum while using the lowest output power
possible.

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 13.0.2 Basic Precautions

DO NOT operate the SONIX Ultrasound System in the presence of flammable anesthetics.

NEVER allow water or other liquids onto the keyboard, operator console or interior of the
system case.

ALWAYS handle transducers with care. Dropping the transducer or allowing it to strike a
hard surface can damage the transducer elements and the acoustic lens. Such a collision
can also crack the transducer housing and destroy its electrical safety features.

To avoid the risk of electrical shock, before using the transducer, inspect the transducer
face, housing and cable. DO NOT use the transducer if the transducer or cable is
damaged.

ALWAYS turn off the system before cleaning or changing fuses.

To avoid the risk of electrical shock and fire hazard, inspect the power supply, AC power
cord and plug on a regular basis. Ensure they are not damaged.

Follow local governing ordinances and recycling plans regarding disposal or recycling of
device components.

Keep the system clean. Carefully follow the procedures described later in this manual for
cleaning the system, transducers and cooling fans.

ALWAYS FREEZE the system when not imaging to prevent the transducer from
overheating.

Ensure the monitor and operator console are secure when imaging is being done or when
the system is left unattended.

ALWAYS choose the appropriate transducer and parameters for the type of clinical
application.

When scanning subjects, always work to use As Low As Reasonably Achievable (ALARA)
acoustic scanning energies. Refer to section 13.0.1 ALARA Principles and Output
Displays before using the SONIX. Do not use more than the minimum energy necessary to
conduct an ultrasound exam. This is especially necessary where fetal and cephalic scans
are being conducted.

DO NOT remove panels or covers from the system base.

ALWAYS power the system from a grounded outlet.

Ultrasonix does not recommend the use of transducer covers containing natural rubber
latex and talc as these ingredients are known to cause an allergic reaction in some
individuals. Please refer to "21 CFR 801.437” user labeling for more details on latex use.

Where intracavity transducers are used in clinical applications of semi- critical nature (e.g.,
trans-rectal, trans-vaginal, trans-esophageal), any covers used will be STERILE and have
received regulatory clearance for use.

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 Caution: Use of controls or adjustments or performance of procedures other than those
specified herein may result in hazardous exposure to ultrasonic energy.

Caution: Contact Ultrasonix if repairs are needed on the system. Repairs and
components maintenance must be carried out by Ultrasonix authorized
personnel only.

Warning: The SONIX ultrasound system may produce physiological effects of ultrasound
which may cause danger to the patient and operator.

13.0.3 Symbol Definitions

Symbols used on SONIX system are shown and described below:

System Symbols:

Symbol Location Meaning

On the serial plate that

indicates the serial
Alternating current
number and electrical
rating
Patient applied part meets the isolation
On transducers
requirements for type B applied part

Patient applied part meets the isolation

On inputs of ECG module
requirements for type BF applied part
Caution: Dangerous Voltages. Do not
On the warning/caution
remove cover or back. Refer servicing
labels(rear of system)
to qualified service personnel.

On the warning/caution Attention: Consult accompanying

labels documents

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 13.0.4 Electrical Safety Requirements

The SONIX Ultrasound System is classified in accordance with the IEC 601-1, the standard
for Medical Electrical Equipment as follows:

Standard IEC 601-1

Type of protection against electrical Class I

Degree of protection against electrical shock Type B

Degree of protection against ingress of water Ordinary

Warning: Accessory equipment connected to the analog and digital interfaces must be
certified according to the respective IEC standards (IEC 60950 for data
processing equipment and IEC 60601-1 for medical equipment). Furthermore,
all configurations shall comply with the system standard IEC 60601-1. Any
person who connects additional equipment to the signal input part or signal
output part configures a medical system and is therefore responsible for
ensuring that the system complies with the requirements of the system standard
IEC 60601-1-1. If you have any additional questions, contact your Ultrasonix
Customer Engineer.

13.0.5 EMC (Electro-Magnetic Compatibility) Requirements

The SONIX Ultrasound System has special precautions regarding EMC. Always install and
use according to the EMC information provided in the SONIX Service Manual.

Portable and mobile RF communications equipment can affect the SONIX Ultrasound
System.

Transducer cables have to be raised above the ground during scanning.

Warning: The use of accessories, transducers and cables other than those specified by
Ultrasonix may result in increased emissions or decreased immunity of the
SONIX.

13.0.6 Environment Conditions

Operating Environment:
• Ambient Operational Temperature: 61 to 95° F (16 to 55° C)
• Internal Operational Humidity: 10% to 80% (non-condensing)
• Storage Conditions: -4 to 140° F (-20 to 60° C)
• Storage Humidity: 10% to 90% (non-condensing)

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 13.0.7 Limiting Transducer Surface Heating

Ultrasonix has taken precautions to ensure the surface heating of the SONIX ultrasound
transducers will reach “No More Than 430 C in the event of a device malfunction”.

Surface heating may be created by transmitting energy on the same area of a transducer at
a high rate. This heating may occur, for example, during Pulsed Wave Doppler or Color
Doppler imaging. The only SONIX transducer where this surface heating issue could be an
issue is the EC9-5/10 transducer. To limit the surface heating, SONIX software conditions
are used to prevent the same area on the transducer from being excited to a rate of less
than 100us. Thorough testing has shown no noticeable EC9-5/10 transducer surface
heating. For added security the SONIX system high voltage excitation power circuit
contains “Polyswitches” that ensure no more than a specified current can be drawn from
these high-voltages circuits.

13.0.8 Latex

Ultrasonix does not recommend the use of transducer covers containing natural rubber
latex and talc as these ingredients are known to cause an allergic reaction in some
individuals. Please refer to "21 CFR 801.437” user labeling for more details on latex use.

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13.1 TRANSDUCER AND SYSTEM MAINTENANCE

13.1.1 Guidelines

Ultrasonix recommends inspecting the SONIX transducers prior to each use:

• Ensure the transducers are always clean before they are used. There must be no
ultrasound gel (from previous imaging), any debris, films or unusual odors present.
• Ensure there are no cracks or other damage to the transducers before they are
used. Inspect the transducer surfaces for cracks and feel for cracks with finger tips
as well.

Where endocavity transducers are being used in clinical applications of a semi-critical

nature (e.g., trans-rectal or trans-vaginal), ensure the transducer is covered with the
appropriate STERILE transducer cover which has received regulatory clearance for use.

13.1.2 Ultrasound Coupling Gels

The following ultrasound coupling gels are recommended for use with the SONIX
transducers:

Gel Name Manufacturer Address

286 Eldridge Road

Fairfield, NJ, 07004
Aquasonic 100 Parker Laboratories, Inc USA
Ph (800) 631-8888
Fax (973) 276-9510
774 Marine Drive
Bellingham, WA 98225
Clear Image Sonotech, Inc. USA
Ph (360) 671-9121
Fax (360) 671-9024

R.D.#2. Box 118

Echo-Oil® Echo Ultrasound Reedsville, PA 17084
USA
R.D.#2. Box 118
Echotrack® Echo Ultrasound Reedsville, PA 17084
USA

7050 Bramalea Road Unit C58

Mississauga, ON L5S 1S9
Ecogel 100& 200 Echo-Med Pharmaceutical Inc. Canada
Ph (905) 405-1050
Fax (905) 405-0775

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 Do not use gels that contain any of the following solutions:
• Acetone
• Methanol
• Denatured ethyl alcohol
• Mineral oil
• Iodine
• Any lotions or gels that contain perfume.

If there are any questions, please contact Ultrasonix Medical Corporation.

13.1.3 Cleaning/Sterilizing Recommendations and Warnings for all

Non-Invasive Transducers

Warnings:
Never sterilize the transducer with sterilization techniques such as autoclave, ultraviolet,
gamma radiation, gas, steam, or heat sterilization techniques. Severe damage will result
using the above sterilization techniques.
Use of precleaning solutions should be restricted to the external transducer face. DO NOT
get solution on any other areas or surfaces of the transducer. This includes transducer
connectors and contacts.
Some of the chemicals such as phenol, benzothonium chloride, pHisohex, benzoyl
peroxide, hydrogen peroxide are commonly found in clinic and hospital setting, or others
are found in antibacterial skin cleaners or lotions. Use of these chemicals will cause
damage to your transducer.
DO NOT use sterilization or disinfections methods that have not been recommended by
Ultrasonix. Severe damage will result. Please contact Ultrasonix if you have any doubt
about sterilization or disinfection methods.

Warning: Any transducers suspected of being contaminated with Creutzfeld Jacob

disease material cannot be cleaned or sterilized.
Contact Ultrasonix Medical Corporation to obtain instructions on the proper
disposal of these transducers.

Remove the ultrasound transmission gel with a dry or water-moistened soft cloth. It is
recommended that transducers are reprocessed as soon as is reasonably practical
following use.

Note: Repeated processing has minimal effect on these transducers. End of life is normally
determined by wear and damage due to use. Disassembly is not required.

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 13.1.3.1 Cleaning (Non-Invasive Transducers)

To clean the transducer:

1. After every patient exam, wipe the ultrasound transmission gel off the transducer.
2. Wipe the transducer and cable with a dry or water-moistened soft cloth.
3. Wipe the transducer with either:
• a recommended disinfectant
• Metrizyme
• Klenzyme
4. Remove any residue with a soft cloth moistened in water. Do not allow cleaning
solutions or isopropyl alcohol to air dry on the transducer.

Recommended disinfectants are:

High level disinfectant: Low level disinfectant:

• Cidex plus TM • Sani-Cloth
• Wavicide®-01 • T-spray
• Omnicide TM

13.1.3.2 Disinfecting (Non-Invasive Transducers)

The disinfectant solution may be used in accordance with the label instructions.
Recommended disinfectants are:

High level disinfectant: Low level disinfectant:

• Cidex plus TM • Sani-Cloth

• Wavicide®-01 • T-spray
• Omnicide TM

13.1.3.3 Sterilization (Non-Invasive Transducers)

Carefully follow the instructions included with the high level disinfectant.
Recommended disinfectants are:

High level disinfectant:

• Cidex plus TM
• Wavicide®-01
• Omnicide TM

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 13.1.3.4 Maintenance (Non-Invasive Transducers)
Cautions:
DO NOT drop the transducers.
DO NOT hit the transducers against any surface that can dislodge or damage any of the transducer
components.
DO NOT pinch or kink the transducer cable.
DO NOT use a brush to clean the transducer. (Use a soft cloth)
DO NOT immerse the transducer scan head past the first seam in any liquid.
DO NOT soak the transducer for extended periods of time.
DO NOT rinse or immerse near the strain relief.
DO NOT use coupling gels and cleaning agents that have not been recommended by Ultrasonix.
DO NOT use sterilization or disinfections methods that have not been recommended by Ultrasonix.
Severe damage will result. Please contact Ultrasonix if you have any doubt about sterilization or
disinfection methods. Use of non-recommended cleaning agents may cause damage to the housing
and will void transducer warranties.
DO NOT use chemicals such as phenol, benzothonium chloride, pHisohex, benzoyl peroxide,
hydrogen peroxide – commonly found in hospitals or clinics. These chemicals will damage the
transducer.

13.1.3.5 Inspection and Testing (Non-Invasive Transducers)

Inspect the transducers prior to each use:

• Always ensure the transducers are always clean before they are used. There must
be no ultrasound gel (from previous imaging), debris, films, or unusual odors
present.
• Ensure there are no cracks or other damage to the transducers before they are
used. Inspect the transducer surfaces for cracks and feel for cracks with finger tips
as well.
Cautions:
DO NOT use transducers if they are found to be cracked, damaged, or broken.
DO NOT use the transducer if transducer cable insulation is damaged, thereby exposing the wiring.

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 13.1.3.6 Storing and Packaging (Non-Invasive Transducers)

Always ensure the transducer is clean and disinfected before storing and/or packing it. This
will help to avoid contaminating the transducer holders or the foam lining of the carrying
case.
• store in one of the transducer holders
• avoid storing the transducer in areas with extreme temperatures or in direct
sunlight.
After placing a transducer in its carrying case, wrap the case in bubble wrap and place the
wrapped case in a cardboard box.

13.1.4 Cleaning/Sterilizing Recommendations and Warnings for all

Invasive Transducers

Warnings:
Never sterilize the transducer with sterilization techniques such as autoclave, ultraviolet,
gamma radiation, gas, steam, or heat sterilization techniques. Severe damage will result
using the above sterilization techniques.
Use of precleaning solutions should be restricted to the external transducer face. DO NOT
get solution on any other areas or surfaces of the transducer. This includes transducer
connectors and contacts.
Some of the chemicals such as phenol, benzothonium chloride, pHisohex, benzoyl
peroxide, hydrogen peroxide are commonly found in clinic and hospital setting, or others
are found in antibacterial skin cleaners or lotions. Use of these chemicals will cause
damage to your transducer.
Avoid transducer contact with strong solvents such as acetone, freon and other industrial
cleansers.
DO NOT use sterilization or disinfections methods that have not been recommended by
Ultrasonix. Severe damage will result. Please contact Ultrasonix if you have any doubt
about sterilization or disinfection methods.

Warning: Any transducers suspected of being contaminated with Creutzfeld Jacob

disease material cannot be cleaned or sterilized.
Contact Ultrasonix Medical Corporation to obtain instructions on the proper
disposal of these transducers.

Remove the ultrasound transmission gel with a dry or water-moistened soft cloth. It is
recommended that transducers are reprocessed as soon as is reasonably practical
following use.

Note: Repeated processing has minimal effect on these transducers. End of life is normally
determined by wear and damage due to use.

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 13.1.4.1 Cleaning (Invasive Transducers)

Disinfect the transducer prior to the first exam and every exam thereafter.

To clean the transducer:

1. Unplug the transducer.
2. Wash the transducer head and cable with soap and water to remove any protein
buildup; however do not rinse or immerse the transducer near the strain relief.
3. Disinfect the transducer with one of below disinfectants:
TM
• Cidex plus
• Wavicide®-01
• Omnicide TM
4. Remove the transducer from the disinfectant and rinse it thoroughly with sterile water.
5. Check the transducer for any residual organic material. If the residual of glutaraldehyde
left is higher than 10ppm, disinfect the transducer again.
Note: Where endocavity transducers are being used in clinical applications of a semi-
critical nature (e.g., trans-rectal or trans-vaginal), ensure the transducer is
covered with the appropriate STERILE transducer cover which has received
regulatory clearance for use.

13.1.4.2 Disinfecting (Invasive Transducers)

The disinfectant solution may be used in accordance with the label instructions.
Recommended disinfectants are:

High level disinfectant:

• Cidex plus TM
• Wavicide®-01
• Omnicide TM

13.1.4.3 Sterilization (Invasive Transducers)

Carefully follow the instructions included with the high level disinfectant.
Recommended disinfectants are:

High level disinfectant:

• Cidex plus TM
• Wavicide®-01
• Omnicide TM

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 13.1.4.4 Maintenance (Invasive Transducers)
Cautions:
DO NOT drop the transducers.
DO NOT hit the transducers against any surface that can dislodge or damage any of the transducer
components.
DO NOT pinch or kink the transducer cable.
DO NOT use a brush to clean the transducer. (Use a soft cloth.)
DO NOT immerse the transducer scan head past the first seam in any liquid.
DO NOT soak the transducer for extended periods of time.
DO NOT rinse or immerse near the strain relief.
DO NOT use coupling gels and cleaning agents that have not been recommended by Ultrasonix.
DO NOT use sterilization or disinfections methods that have not been recommended by Ultrasonix.
Severe damage will result. Please contact Ultrasonix if you have any doubt about sterilization or
disinfection methods. Use of non-recommended cleaning agents may cause damage to the housing
and will void transducer warranties.
DO NOT use chemicals such as phenol, benzothonium chloride, pHisohex, benzoyl peroxide,
hydrogen peroxide – commonly found in hospitals or clinics. These chemicals will damage the
transducer.

13.1.4.5 Inspection and Testing (Invasive Transducers)

Inspect the transducers prior to each use:

• Always ensure the transducers are always clean before they are used. There must
be no ultrasound gel (from previous imaging), debris, films, or unusual odors
present.
• Ensure there are no cracks or other damage to the transducers before they are
used. Inspect the transducer surfaces for cracks and feel for cracks with finger tips
as well.

Cautions:
DO NOT use transducers if they are found to be cracked, damaged, or broken.
DO NOT use the transducer if transducer cable insulation is damaged, thereby exposing the wiring.

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 13.1.4.6 Storing and Packaging (Invasive Transducers)

Always ensure the transducer is clean and disinfected before storing and/or packing it. This
will help to avoid contaminating the transducer holders or the foam lining of the carrying
case.
• store in one of the transducer holders
• store the transducer separately from other instruments to avoid inadvertent
transducer damage
• if storing the transducer in the original case or in a drawer, make sure the
transducer is thoroughly dry.
• avoid storing the transducer in areas with extreme temperatures or in direct
sunlight.
After placing a transducer in its carrying case, wrap the case in bubble wrap and place the
wrapped case in a cardboard box.

13.1.5 System Cleaning Recommendations

Ultrasonix recommends the following cleaning instructions for the SONIX system
components.

13.1.5.1 SONIX LCD Monitor Cleaning:

Turn off the system prior to cleaning the monitor. Apply a small amount of one of the
following recommended cleaning solutions to a soft, non-abrasive cloth:
• Water
• Vinegar/water solution
• Isopropyl Alcohol (i.e., Windex)
• Petroleum Benzene

Stroke the cloth across the display in one direction, moving from the top of the display to
the bottom.
Computer wipes may be used only if they specifically state they are designed for LCD
screens.
DO NOT apply the cleaning solution directly to the LCD.
DO NOT scratch the LCD screen.
DO NOT use paper towels to clean the LCD screen as they may cause damage and
scratches.
NEVER use any cleaning products containing the following:
• Acetone
• Ethyl Alcohol
• Ethyl acid
• Ammonia
• Methyl chloride

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 13.1.5.2 Touch Screen Cleaning:

Turn off the system prior to cleaning the touch screen on the operator console. Apply a
small amount of one of the following recommended cleaning solutions to a soft, non-
abrasive cloth:
• Water
• 1% Isopropyl Alcohol

DO NOT apply the cleaning solution directly to the touch screen.

DO NOT scratch the touch screen.
DO NOT use paper towels to clean the console touch screen as they may cause damage
and scratches.

13.1.5.3 Operator Console Cleaning:

Caution: DO NOT apply cleaning solutions directly to the operator console.

Turn off the system prior to cleaning the operator console. Apply a small amount of one of
the following recommended cleaning solutions to a soft, non-abrasive cloth:
• Water
• Mild detergent (PH level at or near 7) water solution

13.1.5.4 Transducer Cleaning:

Please be sure to clean and disinfect the SONIX transducers prior to use and storage.
Refer to section 13.1.3 and 13.1.4 for further details on transducer maintenance and
cleaning.

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CHAPTER 14 - REFERENCES

14.0 OB REFERENCES
AFI (Amniotic Fluid Index)
Jeng, C. J., et al. “Amniotic Fluid Index Measurement with the Four Quadrant Technique
During Pregnancy.” The Journal of Reproductive Medicine, 35:7 (July 1990), 674-677.
Moore, T. R, et al. “The amniotic fluid index in normal human pregnancy.” American Journal of
Obstetrics and Gynecology, (1990) 162: 1168-1173

EFW (Estimated Fetal Weight)

Hadlock, F., et al. “Estimated of Fetal Weight with the Use of Head, Body, and Femur
Measurements, A Prospective Study.” American Journal of Obstetrics and Gynecology, 151:13
(February 1, 1985), 333-337.
Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-
Verlag, (1986), 154.
Osaka University. Ultrasound in Obstetrics and Gynecology. (July 20, 1990), 103-105
Shepard M.J., V.A. Richards, R.L. Berkowitz, et al. “An Evaluation of Two Equations for
Predicting Fetal Weight by Ultrasound.” American Journal of Obstetrics and Gynecology, 142:1
(January 1, 1982), 47-54.
Tokyo, Shinozuka, N. FJSUM, et al. “Standard Values of Ultrasonographic Fetal Biometry.”
Japanese Journal of Medical Ultrasonics, 23:12 (1996), 880, Equation 1

FL/AC Ratio (Femur Length/Abdominal Circumference)

Hadlock, F.P., R.L. Deter, R.B. Harrist, E. Roecker, and S.K. Park. “A Date Independent
Predictor of Intrauterine Growth Retardation: Femur Length/Abdominal Circumference Ratio,”
American Journal of Roentgenology, 141: (November 1983), 979-984.

FL/BPD Ratio (Femur Length/Biparietal Diameter)

Hohler, C.W. & T.A. Quetel. “Comparison of Ultrasound Femur Length and Biparietal Diameter
in Late Pregnancy,” American Journal of Obstetrics and Gynecology, 141:7 (Dec. 1 1981), 759-
762.

FL/HC Ratio (Femur Length/Head Circumference)

Hadlock, F.P., R.B. Harrist, Y. Shah, & S/K. Park. “The Femur Length/Head Circumference
Relation in Obstetric Sonography.” Journal of Ultrasound in Medicine, 3: (October 1984), 439-
442.

HC/AC Ratio (Head Circumference/Abdominal Circumference)

Campbell, S., Thomas Alison. “Ultrasound Measurements of the Fetal Head to Abdomen
Circumference Ratio in the Assessment of Growth Retardation,” British Journal of Obstetrics
and Gynaecology, 84: (March 1977), 165-174.

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 Gestational Age Tables:
AC (Abdominal Circumference)
Hadlock, F., et al. “Estimated Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth
Parameters.” Radiology, 152: (1984), 497-501.
Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-
Verlag, (1986), 431.
Lessoway, V A. et al. “Ultrasound Fetal Biometry Charts for a North American Caucasian
Population.” Journal of Clinical Ultrasound, Vol 26, No 9 (1998), 433-453.
Tokyo, Shinozuka, N. FJSUM, et al. “Standard Values of Ultrasonographic Fetal Biometry.”
Japanese Journal of Medical Ultrasonics, 23:12 (1996), 885

BPD (Biparietal Diameter)

Hadlock,F., et al. “Estimated Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth
Parameters.” Radiology, 152 : 1984), 497-501.
Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-
Verlag, (1986), 440.
Lessoway, V A. et al. “Ultrasound Fetal Biometry Charts for a North American Caucasian
Population.” Journal of Clinical Ultrasound, Vol 26, No 9 (1998), 433-453.
Osaka University. Ultrasound in Obstetrics and Gynecology. (July 20, 1990), 98
Tokyo, Shinozuka, N. FJSUM, et al. “Standard Values of Ultrasonographic Fetal Biometry.”
Japanese Journal of Medical Ultrasonics, 23:12 (1996), 885

Cereb (Cerebellum)
Hill, Lyndon, M., et al. “The Transverse Cerebellar Diameter in Estimating Gestational Age in
the Large for Gestational Age Fetus.” Obstetrics and Gynecology, (June 1990) Vol. 75, No. 6,
981-985

CI (Cephalic Index)
Hadlock FP, et al., “Estimating Fetal Age: Effects on Head Shape on BPD,” American Journal
Roentgen, 1981; 137:83-85

CRL (Crown Rump Length)

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. NewYork: Springer-
Verlag, (1986), 439.
Lessoway, V A. et al. “Ultrasound Fetal Biometry Charts for a North American Caucasian
Population.” Journal of Clinical Ultrasound, Vol 26, No 9 (1998), 433-453.
Osaka University. Ultrasound in Obstetrics and Gynecology. (July 20, 1990)
Rempen, German Society for Gynecology and Obstetrics, March 1991, Issue 15, Vol 1, pp. 23
-28

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 FL (Femur Length)
Hadlock, F., et al. “Estimated Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth
Parameters.” Radiology, 152:(1984), 497-501.
Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-
Verlag, (1986), 431.
Lessoway, V A. et al. “Ultrasound Fetal Biometry Charts for a North American Caucasian
Population.” Journal of Clinical Ultrasound, Vol 26, No 9 (1998), 433-453.
Merz, German Society for Gynecology and Obstetrics, March 1991, Issue 15, Vol 1, pp. 23 -28
Osaka University. Ultrasound in Obstetrics and Gynecology. (July 20, 1990), 101-102
Tokyo, Shinozuka, N. FJSUM, et al. “Standard Values of Ultrasonographic Fetal Biometry.”
Japanese Journal of Medical Ultrasonics, 23:12 (1996), 886

FTA (Fetal Trunk Area)

Osaka University. Ultrasound in Obstetrics and Gynecology. (July 20, 1990), 99-100

GS (Gestational Sac)
Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-
Verlag, (1986)
Nyberg, D.A., et al. “Transvaginal Ultrasound.” Mosby Yearbook, (1992), 76.
Rempen, German Society for Gynecology and Obstetrics, March 1991, Issue 15, Vol 1, pp. 23
-28

HC (Head Circumference )
Hadlock,F., et al. “Estimated Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth
Parameters.” Radiology, 152:(1984), 497-501.
Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-
Verlag, (1986), 431.
Lessoway, V A. et al. “Ultrasound Fetal Biometry Charts for a North American Caucasian
Population.” Journal of Clinical Ultrasound, Vol 26, No 9 (1998), 433-453.

HL (Humeral Length)
Jeanty P, et al. “Estimation of Gestational Age from Measurements of Fetal Long Bones.“
Journal of Ultrasound Medicine (1984) 3:75-79

OFD (Occipito-Frontal Diameter)

Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-
Verlag, (1986), 431.

TL (Tibial Length)
Jeanty P, et al. “Estimation of Gestational Age from Measurements of Fetal Long Bones.“
Journal of Ultrasound Medicine (1984) 3:75-79

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 TTD (Transverse Trunk Diameter)
Hansmann, M., et al. Ultrasound Diagnosis in Obstetrics and Gynecology. New York: Springer-
Verlag, (1986), 431.

UL (Ulnarl Length)
Jeanty P, et al. “Estimation of Gestational Age from Measurements of Fetal Long Bones.“
Journal of Ultrasound Medicine (1984) 3:75-79

Growth Analysis Tables:

AC (Abdominal Circumference)
Hadlock, F., et al. “Estimated Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth
Parameters.” Radiology, 152:(1984), 497-501.
Lessoway, V A. et al. “Ultrasound Fetal Biometry Charts for a North American Caucasian
Population.” Journal of Clinical Ultrasound, Vol 26, No 9 (1998), 433-453.
Tokyo, Shinozuka, N. FJSUM, et al. “Standard Values of Ultrasonographic Fetal Biometry.”
Japanese Journal of Medical Ultrasonics, 23:12 (1996)

BPD (Biparietal Diameter)

Hadlock, F., et al. “Estimated Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth
Parameters.” Radiology, 152:(1984), 497-501.
Lessoway, V A. et al. “Ultrasound Fetal Biometry Charts for a North American Caucasian
Population.” Journal of Clinical Ultrasound, Vol 26, No 9 (1998), 433-453.
Osaka University. Ultrasound in Obstetrics and Gynecology. (July 20, 1990), 101-102
Tokyo, Shinozuka, N. FJSUM, et al. “Standard Values of Ultrasonographic Fetal Biometry.”
Japanese Journal of Medical Ultrasonics, 23:12 (1996)

CRL (Crown Rump Length)

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.
Lessoway, V A. et al. “Ultrasound Fetal Biometry Charts for a North American Caucasian
Population.” Journal of Clinical Ultrasound, Vol 26, No 9 (1998), 433-453.
Osaka University. Ultrasound in Obstetrics and Gynecology. (July 20, 1990)

EFW (Estimated Fetal Weight)

Hadlock, F., et al. “In Utero Analysis of Fetal Growth: A Sonographic Weight Standard.”
Radiology, 181:(1991), 129-133.
Osaka University. Ultrasound in Obstetrics and Gynecology. (July 20, 1990)

FL (Femur Length)
Hadlock, F., et al. “Estimated Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth
Parameters.” Radiology, 152:(1984), 497-501.
Jeanty P., E. et al. “Ultrasonic Evaluation of Fetal Limb Growth.” Radiology (1982)143: 751-754

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 Lessoway, V A. et al. “Ultrasound Fetal Biometry Charts for a North American Caucasian
Population.” Journal of Clinical Ultrasound, Vol 26, No 9 (1998), 433-453.
Osaka University. Ultrasound in Obstetrics and Gynecology. (July 20, 1990)
Tokyo, Shinozuka, N. FJSUM, et al. “Standard Values of Ultrasonographic Fetal Biometry.”
Japanese Journal of Medical Ultrasonics, 23:12 (1996)

FTA (Fetal Trunk Area)

Osaka University. Ultrasound in Obstetrics and Gynecology. (July 20, 1990), 99-100

HC (Head Circumference)
Hadlock, F., et al. “Estimated Fetal Age: Computer-Assisted Analysis of Multiple Fetal Growth
Parameters.” Radiology, 152:(1984), 497-501.
Lessoway, V A. et al. “Ultrasound Fetal Biometry Charts for a North American Caucasian
Population.” Journal of Clinical Ultrasound, Vol 26, No 9 (1998), 433-453.

HC/AC (Head Circumference/Abdominal Circumference)

Campbell S., Thomas Alison. “Ultrasound Measurements of the Fetal Head to Abdomen
Circumference Ratio in the Assessment of Growth Retardation,” British Journal Obstetrics and
Gynaecology, 84: (March 1977), 165-174.

HL (Humeral Length)
Jeanty P., E. et al. “Ultrasonic Evaluation of Fetal Limb Growth.” Radiology (1982) 143: 751-
754

14.1 GENERAL AND CARDIAC REFERENCES

ACC (Acceleration)
Zwiebel, W.J. Introduction to Vascular Ultrasonography. 4th ed., W.B. Saunders Company,
(2000), 52.

AT (Acceleration Time) & DT (Deceleration Time)

Oh, J.K., J.B. Seward, A.J.Tajik. The Echo Manual. 2nd ed., Lippincott, Williams, and Wikins,
(1999), 219.

CSA (Cross Sectional Area)

Reynolds, Terry. The Echocardiographer’s Pocket reference. 2nd ed., School of Cardiac
Ultrasound, Arizona Heart Institute, (2000), 383.

ET (Elapsed Time)
Redberg, Rita F., MD and Vogel, Robert A., MD, et al. “Task force #3 – what is the Spectrum of
Current and Emerging Techniques for the Noninvasive Measurement of Atherosclerosis?”
Journal of the American College of Cardiology. (June 4, 2003), 41:11, 1886-1898.

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 % Area Red and % A Red (Percent Area Reduction)
Taylor K.J.W., P.N. Burns, P. Breslau. Clinical Applications of Doppler Ultrasound, Raven
Press, N.Y., (1988), 130-136.
Zwiebel W.J., J.A. Zagzebski, A.B. Crummy, et al. “Correlation of peak Doppler frequency with
lumen narrowing in carotid stenosis.” Stroke, 3: (1982), 386-391.

% Diam Red and % D Red (Percent Diameter Reduction)

Handa, Nobuo et al., “Echo-Doppler Velocimeter in the Diagnosis of Hypertensive Patients:
The Renal Artery Doppler Technique,” Ultrasound in Medicine and Biology, 12:12 (1986), 945-
952.

PGr (Pressure Gradient) mmHG

Oh, J.K., J.B. Seward, A.J. Tajik. The Echo Manual. 2nd ed., Lippincott, Williams, and Wilkins,
(1999), 64.

PHT (Pressure Half Time)

Reynolds, Terry. The Echocardiographer’s Pocket reference. 2nd ed., School of Cardiac
Ultrasound, Arizona Heart Institute, (2000), 391.

PI (Pulsatility Index)
Kurtz, A.B. W.D. Middleton. Ultrasound-the Requisites. Mosby Year Book., Inc., (1996), 469.

RI (Resistive Index)
Kurtz, A.B., W.D. Middleton. Ultrasound-the Requisites. Mosby Year Book., (1996), 467.

VTI (Velocity Time Integral)

Reynolds, Terry. The Echocardiographer’s Pocket reference. 2nd ed., School of Cardiac
Ultrasound, Arizona Heart Institute, (2000), 383.

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CHAPTER 15 - GLOSSARY

Abbreviations and Acronyms

2D Two Dimensional AV Aortic Valve

3D Three Dimensional AVm Mean Average Velocity

4D Four Dimensional (Live 3D) AVp Peak Average Velocity

4DC 4D Curved Array Transducer B/M Mode 2D and M-Mode

Abd Abdomen Base Baseline (i.e., Doppler Baseline)

AC Abdominal Circumference BBT Basal Body Temperature

ACC Acceleration BGR Blue Green Red

AC Alternating Current (power supply) BNC Bayonet Neill Concelman

AD Angio Doppler BPD Biparietal Diameter

Admin Administrative BSA Body Surface Area

AE Application Entity (DICOM) Calcs Calculations

AFI Amniotic Fluid Index Card Cardiology

AFV Amniotic Fluid Volume CCA Common Carotid Artery

AIUM American Institute of Ultrasound in CD Compact Disc

Medicine
Cereb Cerebellum
ALARA As Low As Reasonably Achievable
CEREB Cerebellum
Ao Aorta
CFM Color Flow Mode
AO/LA Aorta/Left Atrium
CI Cephalic Index
AoV Aortic Valve
CIR Circumference
APD Anterior Posterior Diameter
COR Coronal
APTD Anterior Posterior Thorax Diameter
CRL Crown Rump Length
AR Area
CSA Cross Sectional Area
AT Acceleration Time
CW Continuous Wave
AUA Average Ultrasound Age
CWD Continuous Wave Doppler

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DEL Delete GA Gestational Age

DICOM Digital Imaging and Gen General

Communications in Medicine
GS Gestational Sac
DIST Distal
Gyn Gynecology
Dist Distance
HC Head Circumference
DPD Directional Power Doppler
HL Humeral Length
DT Deceleration Time
HR Heart Rate
DVD Digital Video Device
ICA Internal Carotid Artery
Dyn Dynamic Range
ICT Intracavity Transducer
EC Endocavity
IP Internet Protocol
ECA External Carotid Artery
IVS Interventricular Septum
EDD Estimated Date of Delivery
LA Long Axis
EDV End Diastolic Velocity
LA Left Atrium
EDVPG EDV Pressure Gradient
LAT Lateral
EF Ejection Fraction
LCD Liquid Crystal Display
EFW Estimated Fetal Weight
LMP Last Menstrual Period
EPSS E Point Septal Separation
LONG Longitudinal
ET Elapsed Time
LOV Left Ovary
EV Endovaginal
LT Left
FDA U.S. Food and Drug Administration
LV Left Ventricle
FHR Fetal Heart Rate
LVD Left Ventricular Diameter
FL Femur Length
LVOT Left Ventricular Outflow Tract
FOV Field Of View
LVPW Left Ventricular Posterior Wall
FR Frame Rate
MCA Middle Cerebral Artery
Freq Frequency
MED Medial
FrRate Frame Rate
MGr Mean Gradient
FTA Fetal Trunk Area

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MI Mechanical Index PSV Peak Systolic Velocity

M-M Motion Mode PSVPG PSV Pressure Gradient

MPR Multiplanar Reconstruction PV Peak Velocity

Msk Musculoskeletal PV Pulmonary Valve

MV Mean Velocity PW Pulsed Wave Doppler

MV Mitral Valve PWD Power Doppler

NEMA National Electrical Manufacturers Q Quadrant (i.e., AFI)

Association
Rad Radius
NF Nuchal Fold
Rect Rectangle
NT Nuchal Thickness
Res Resolution
NTSC National Television Standards
Committee
RF Radio Frequency
OB Obstetrics
RGB Red Green Blue
OD Optical Density
RI Resistive Index
OEM Original Equipment Manufacturer
ROI Region of Interest
OFD Occipital-Frontal Diameter
ROV Right Ovary
OOD Outer Orbital Diameter
RT Right
PA Phased Array
RV Right Ventricle
PAL Phased Alternating Line
RVOT Right Ventricular Outflow Tract
Pano Panoramic Imaging Mode
SA Short Axis
Pel Pelvis
SAG Sagital
Pen Penetration
SCP Service Class Provider
Persist Persistence
SCU Service Class User
PGr Pressure Gradient
SD Standard Deviation
PI Pulsatility Index
SD Systolic/Diastolic Ratio
Picto Pictogram
SDK Software Development Kit
PRF Pulse Repetition Frequency
Simult Simultaneous
PROX Proximal

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SV Stroke Volume UI User Interface

TCP Transfer Control Protocol UL Ulnar Length

TGC Time Gain Compensation URL Uniform Resource Locator

THI Tissue Harmonic Imaging VCR Video Cassette Recorder

TI Thermal Index Vel Velocity

TIB Thermal Index – Bone Vol Volume

TIC Thermal Index – Cranial VPS Volumes per Second

TIS Thermal Index – Soft Tissue VR Volume Rendering

TL Tibia Length VTI Velocity Time Integral

TRANS Transverse WF Wall Filter

Transp Transparency WWW World Wide Web

TTD Transverse Trunk Diameter YS Yolk Sac

TV Tricuspid Valve

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